<subtitle num="01" heading="Procedures"> <chapter num="01" heading="Income Tax Credits for Preceptors in Areas with Health Care Workforce Shortages"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>The purpose of this chapter is to establish regulatory provisions related to the State income tax credit program for the following qualified health care practitioners who serve as preceptors without compensation in health care workforce shortage areas:</text> <paragraph num="(1)"> <text>Physicians;</text> </paragraph> <paragraph num="(2)"> <text>Advanced practice registered nurses;</text> </paragraph> <paragraph num="(3)"> <text>Physician assistants;</text> </paragraph> <paragraph num="(4)"> <text>Registered nurses; and</text> </paragraph> <paragraph num="(5)"> <text>Licensed practical nurses.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter describes the procedures used by the Maryland Department of Health to assess eligibility of applicants, process applications, and certify income tax credits for approved applications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual:</text> <paragraph num="(a)"> <text>Who has submitted an application to the Department requesting State income tax credit; and</text> </paragraph> <paragraph num="(b)"> <text>Whose status for receipt of a tax credit certification has not yet been determined.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Health Care Practitioner” means an individual who is:</text> <paragraph num="(a)"> <text>A health care practitioner, as defined in Tax-General Article, §10–752, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>An advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>A licensed practical nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Health care workforce shortage area” means:</text> <paragraph num="(a)"> <text>A health professional shortage area;</text> </paragraph> <paragraph num="(b)"> <text>A medically underserved area;</text> </paragraph> <paragraph num="(c)"> <text>A medically underserved population;</text> </paragraph> <paragraph num="(d)"> <text>Federally designated rural areas;</text> </paragraph> <paragraph num="(e)"> <text>State defined shortage areas;</text> </paragraph> <paragraph num="(f)"> <text>State defined rural areas; or</text> </paragraph> <paragraph num="(g)"> <text>Other areas defined as in need by the Secretary of Health or Governor or as otherwise determined by the Department in consultation with the Governor’s Workforce Development Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Income tax credit” means a nonrefundable credit against State income tax.</text> </paragraph> <paragraph num="(6)"> <text>“Preceptor” means a health care practitioner participating in a preceptorship program.</text> </paragraph> <paragraph num="(7)"> <text>“Preceptorship program” has the meaning as stated in Tax-General Article, §§10–738, and 10-752, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Rotation” means a minimum of:</text> <paragraph num="(a)"> <text>100 hours of community-based clinical training between a:</text> <paragraph num="(i)"> <text>Medical student and a licensed physician preceptor;</text> </paragraph> <paragraph num="(ii)"> <text>Physician assistant student and a licensed physician, nurse practitioner, or physician assistant preceptor in family medicine, general internal medicine, or general pediatrics practice or setting; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>90 hours of community-based clinical training between a:</text> <paragraph num="(i)"> <text>Nurse practitioner student and a licensed physician or nurse practitioner preceptor;</text> </paragraph> <paragraph num="(ii)"> <text>A registered nurse student and an advanced practice registered nurse or registered nurse preceptor; or</text> </paragraph> <paragraph num="(iii)"> <text>A licensed practical nurse student and an advanced practice registered nurse, registered nurse, or licensed practical nurse preceptor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Taxable year” means the annual accounting period for keeping records and reporting income and expenses that starts on January 1 and ends on December 31 of the same year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Eligibility."> <text>A healthcare practitioner preceptor in a preceptorship program is eligible for an income tax credit if the individual served:</text> <paragraph num="A."> <text>Without compensation for a minimum of three rotations; and</text> </paragraph> <paragraph num="B."> <text>In a health care workforce shortage area.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Procedures."> <paragraph num="A."> <text>Applicant.</text> <paragraph num="(1)"> <text>By the published deadlines, on the form designated by the Department, an applicant shall:</text> <paragraph num="(a)"> <text>Submit a complete application to the Department;</text> </paragraph> <paragraph num="(b)"> <text>Facilitate submission of application components by all contributors; and</text> </paragraph> <paragraph num="(c)"> <text>Provide any supporting documentation as requested by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant may voluntarily withdraw the application without prejudice.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may submit a new application subject to §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall receive applications by January 5 for the previous taxable year during which rotations were completed.</text> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Accept applications received during the application period for Department review;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application if the:</text> <paragraph num="(a)"> <text>Application is complete;</text> </paragraph> <paragraph num="(b)"> <text>Applicant is determined to be eligible; and</text> </paragraph> <paragraph num="(c)"> <text>Funds are available in the appropriate Fund based on precepted student type;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Disapprove an application if the application:</text> <paragraph num="(a)"> <text>Fails to provide sufficient information or comply with requested documentation to determine eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Has the appropriate documentation but is determined to be ineligible; or</text> </paragraph> <paragraph num="(c)"> <text>Does not satisfy the requirements established by law or the Department; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide the applicant with written notice of the final disposition of the application within 45 calendar days of receipt of an application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Appeal of Disapproval of Application.</text> <paragraph num="(1)"> <text>An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application.</text> </paragraph> <paragraph num="(2)"> <text>If an applicant submits an appeal, the Department, within 60 calendar days of receipt of the appeal, shall:</text> <paragraph num="(a)"> <text>Sustain or reverse the decision on the application; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the decision on the application has been sustained or reversed; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. Following receipt of the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> <paragraph num="(4)"> <text>Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in:</text> <paragraph num="(a)"> <text>The appeal nullified and decision sustained;</text> </paragraph> <paragraph num="(b)"> <text>The hearing on the appeal not being rescheduled; or</text> </paragraph> <paragraph num="(c)"> <text>Appropriate sanctions as determined by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Verification and Audit of Income Tax Credits."> <paragraph num="A."> <text>The Department may:</text> <paragraph num="(1)"> <text>Request from an applicant additional information to verify statements in an application; and</text> </paragraph> <paragraph num="(2)"> <text>Use independent verification, such as a preceptor list and preceptor completion letters received by the medical and nursing schools, to verify information reported on an application for an income tax credit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Comptroller shall retain its audit authority under Tax-General Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Income Tax Credits."> <paragraph num="A."> <text>On approval of an application, the Department shall issue an income tax credit certificate to the approved healthcare practitioner in the amount of $1,000 for each qualifying student rotation for which the healthcare practitioner served as a preceptor.</text> </paragraph> <paragraph num="B."> <text>Income tax credits shall be issued for the taxable year of the application during which the health care practitioner served without compensation.</text> </paragraph> <paragraph num="C."> <text>The total amount of an income tax credit allowed for an individual in a taxable year may not exceed the:</text> <paragraph num="(1)"> <text>Maximum credit amount as indicated in Tax-General Article, §§10–738, 10-739, 10-739.1, and 10-752, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>State income tax imposed for that individual for that taxable year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Any unused amount of an income tax credit for a taxable year may not be carried over to any other taxable year by the preceptor, as referenced in Tax-General Article, §§10–738, 10-739, 10-739.1, and 10-752, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Responsibilities of the Comptroller."> <text>On notification that an income tax credit certificate has been issued by the Department, the Comptroller shall transfer an amount equal to the income tax credit amount stated in the income tax credit certificate from the Nurse Practitioner Preceptorship Tax Credit Fund, the Physician Assistant Preceptorship Tax Credit Fund, or Licensed Practical Nurse and Registered Nurse Preceptorship Tax Credit Fund, to the General Fund.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Expiration of Program."> <paragraph num="A."> <text>The Department shall issue final income tax credits based on available funds.</text> </paragraph> <paragraph num="B."> <text>This chapter remains in effect until:</text> <paragraph num="(1)"> <text>The date that funding for income tax credits ceases to be available; or</text> </paragraph> <paragraph num="(2)"> <text>Sunset on June 30, 2030.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Tax-General Article, §§10-738, 10-739, 10-739-1, and 10.752, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 29, 2018 (45:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 19, 2022 (49:19 Md. R. 868)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 2, 2026 (53:4 Md. R. 184)</annotation> </annotations> </chapter> <chapter num="02" heading="Procedures for Public Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to hearings the Secretary conducts to gather information from the general public before making a decision or taking an action such as adopting a regulation or issuing a license, certificate, or permit.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to contested case hearings or any hearing where the purpose is other than to gather information from the public at large or from a person with a specific interest in the issue.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Hearing” means a formal meeting, properly published and convened, the sole purpose of which is to gather information from the public at large, or other group or person as required by law, before making a decision or taking an action.</text> </paragraph> <paragraph num="(3)"> <text>“Hearing examiner” means the Secretary of Health or that employee of the Department designated by the Secretary to conduct a specific hearing or hearings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notice of Hearing."> <paragraph num="A."> <text>The Department shall publish a notice of the hearing in the Maryland Register and any other publication required by law.</text> </paragraph> <paragraph num="B."> <text>The Department shall include in any published or circulated notice of the hearing:</text> <paragraph num="(1)"> <text>The time of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>The place of the hearing, giving the street address, floor, and designated room;</text> </paragraph> <paragraph num="(3)"> <text>The purpose of the hearing;</text> </paragraph> <paragraph num="(4)"> <text>A statement that the Department will make reasonable accommodation for individuals with disabilities if these individuals advise the Department of their special needs by giving the Department reasonable advance notice; and</text> </paragraph> <paragraph num="(5)"> <text>Any other applicable publishing requirements in law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Testimony."> <paragraph num="A."> <text>The hearing examiner shall give all persons present who wish to testify an opportunity to do so but may limit repetitious testimony.</text> </paragraph> <paragraph num="B."> <text>The right of cross-examination is not applicable to hearings under this chapter.</text> </paragraph> <paragraph num="C."> <text>The hearing examiner may:</text> <paragraph num="(1)"> <text>Allow questions from the audience;</text> </paragraph> <paragraph num="(2)"> <text>Take questions from the audience and redirect the questions to others present at the hearing;</text> </paragraph> <paragraph num="(3)"> <text>Ask questions of anyone present at the hearing; and</text> </paragraph> <paragraph num="(4)"> <text>Refer questions to agency personnel who may respond after the hearing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The rules of evidence are inapplicable to hearings under this chapter.</text> </paragraph> <paragraph num="E."> <text>The hearing examiner shall receive and mark all exhibits offered in testimony if they are relevant to the hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Oaths and Affirmations."> <text>The formality of an oath may be dispensed with unless the hearing examiner believes the oath gives some assurance of veracity, formality, or decorum to the hearing.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Conduct and Control of Hearing."> <paragraph num="A."> <text>The hearing examiner shall determine the conduct of the hearing, including:</text> <paragraph num="(1)"> <text>The order of presentation; and</text> </paragraph> <paragraph num="(2)"> <text>Time limits for questions and testimony.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hearing examiner may:</text> <paragraph num="(1)"> <text>Order a person who engages in disruptive behavior, such as waving a sign or placard or shouting or jeering, that interferes with the orderly conduct of the hearing, to be removed from the hearing;</text> </paragraph> <paragraph num="(2)"> <text>Request police assistance to assure or restore order; and</text> </paragraph> <paragraph num="(3)"> <text>Recess a disorderly hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Recording, Photographing, Videotaping, Broadcasting, and Televising of Hearings.</text> <paragraph num="(1)"> <text>Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, may record a hearing with a tape recorder or other recording device if the:</text> <paragraph num="(a)"> <text>Device does not create excessive noise that interferes with the participation in or the observation of the hearing by a person present; and</text> </paragraph> <paragraph num="(b)"> <text>Recording is done openly so that it is obvious to those in attendance that the hearing is being recorded.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, may photograph, videotape, televise, or broadcast the proceedings of a hearing with a camera if the camera:</text> <paragraph num="(a)"> <text>Is operated without excessively bright or hot artificial light or excessive noise that interferes with the participation in or the observation of the hearing by a person present; and</text> </paragraph> <paragraph num="(b)"> <text>Is used openly so that it is obvious to those in attendance that the hearing is being recorded.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The hearing examiner may restrict the movement of a person who is using a recording device, camera, or broadcasting or televising equipment if the restriction is necessary to maintain the orderly conduct of the hearing.</text> </paragraph> <paragraph num="(4)"> <text>Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, who is recording, photographing, videotaping, broadcasting, or televising a hearing does not need to obtain the consent of a member of the public at the hearing to do so if the recording, photographing, videotaping, broadcasting, or televising is done openly so that it is obvious to those in attendance.</text> </paragraph> <paragraph num="(5)"> <text>A person who wishes to testify without being photographed, videotaped, or televised or without being recorded by anyone other than the court reporter service or Department may do so by making such a request of the hearing examiner.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A recording of a hearing made by anyone other than the court reporter service or Department, or a transcript derived from such a recording, is not part of the record of a hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="The Transcript."> <paragraph num="A."> <text>At the Department's discretion, the Department or a court reporter service shall stenographically record verbatim or tape record the hearing.</text> </paragraph> <paragraph num="B."> <text>If a court reporter service records the hearing:</text> <paragraph num="(1)"> <text>The Department shall arrange for the court reporter service to retain the tape recording or stenographic recording for 1 year following the final decision or action; and</text> </paragraph> <paragraph num="(2)"> <text>A person who desires a copy of the transcript may purchase a copy from the court reporter service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an employee of the Department records the hearing:</text> <paragraph num="(1)"> <text>The Department shall keep the tape recording or stenographic recording with the original of the record; and</text> </paragraph> <paragraph num="(2)"> <text>A person who desires a copy of the transcript may purchase a copy from the Department for a reasonable cost in accordance with COMAR 10.01.08.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="The Record."> <paragraph num="A."> <text>The hearing examiner controls the record.</text> </paragraph> <paragraph num="B."> <text>The hearing examiner shall assemble a record that consists of all of the following:</text> <paragraph num="(1)"> <text>Exhibits and documents entered into the record, such as:</text> <paragraph num="(a)"> <text>Proposed regulations or applications for licenses, certificates, or permits,</text> </paragraph> <paragraph num="(b)"> <text>Documentation of public notification of the hearing, and</text> </paragraph> <paragraph num="(c)"> <text>Relevant supporting and opposing documentation obtained before, during, and subsequent to the hearing;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The register of all persons who attended the hearing including their names, addresses, and any affiliations relevant to the hearing;</text> </paragraph> <paragraph num="(3)"> <text>In accordance with Regulation .07 of this chapter, any:</text> <paragraph num="(a)"> <text>Full or partial transcript of the hearing made or purchased by the Department, and</text> </paragraph> <paragraph num="(b)"> <text>Tape recording or stenographic notes of the hearing made by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A hearing examiner's report consisting of all of the following:</text> <paragraph num="(a)"> <text>A statement of the purpose of the hearing including citations of applicable laws and regulations,</text> </paragraph> <paragraph num="(b)"> <text>An account of the methods of public notification of the hearing,</text> </paragraph> <paragraph num="(c)"> <text>An account of the attendance and conduct of the hearing,</text> </paragraph> <paragraph num="(d)"> <text>A summary of supporting and opposing arguments and analyses of those arguments in light of relevant laws and regulations,</text> </paragraph> <paragraph num="(e)"> <text>Relevant findings such as compliance with law or sufficiency of proposed regulations, and</text> </paragraph> <paragraph num="(f)"> <text>Conclusions and recommendations for a final decision; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The final decision of the decision-making authority.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Maintenance of and public access to the record is governed by State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland, and by COMAR 10.01.08.</text> </paragraph> <paragraph num="D."> <text>The Department shall maintain copies of the record as follows:</text> <paragraph num="(1)"> <text>The Office of the Secretary shall maintain the original of the record; and</text> </paragraph> <paragraph num="(2)"> <text>Except for the tape recording or stenographic notes specified in §B(3)(b) of this regulation, the office of the director of the unit concerned shall maintain a copy of the record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Postponement and Continuance."> <text>The hearing examiner has sole discretion over:</text> <paragraph num="A."> <text>Postponement or continuance of the hearing; and</text> </paragraph> <paragraph num="B."> <text>Keeping the record open beyond the date of the hearing.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new Regulations .01—.09 adopted effective September 13, 1993 (20:18 Md. R. 1429)</annotation> </annotations> </chapter> <chapter num="03" heading="Procedures for Hearings Before the Secretary of Health"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to hearings that the Secretary is required to conduct by statute or regulation except for those hearings for which specific procedural regulations have been promulgated. This chapter does not apply to conferences, investigations, or proceedings at which the general public has been assembled to provide comments and opinions regarding a permit or license proposed to be issued by the Department, or to hearings before the Department’s Boards and Commissions, which are authorized by law to conduct their own hearings.</text> </paragraph> <paragraph num="B."> <text>These procedures are intended to supplement the procedures required by law. They are not substantive and are not to be construed as creating rights not set out by law. In the event of conflict, statutory provisions take precedence over this chapter.</text> </paragraph> <paragraph num="C."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this chapter shall be construed, whenever possible, as supplementing COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In a conflict between this chapter and COMAR 28.02.01, this chapter applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Civil Penalty.</text> <paragraph num="(a)"> <text>“Civil penalty” means a monetary penalty authorized by statute or regulation and imposed for a violation of a statute, regulation, permit, or license.</text> </paragraph> <paragraph num="(b)"> <text>“Civil penalty” does not include statutorily authorized reimbursement of State or federal expenditures.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health, or any of its constituent units.</text> </paragraph> <paragraph num="(3)"> <text>“Hearing” means a contested case hearing as defined by the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Administrative Law Judge (ALJ)” means an administrative law judge of the Office of Administrative Hearings as defined in COMAR 28.02.01.02B(1).</text> </paragraph> <paragraph num="(5)"> <text>“Office of Administrative Hearings (OAH)” means the independent unit in the Executive Branch of State government authorized to conduct hearings in contested cases, pursuant to the Administrative Procedures Act and this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Party” means any person or agency named or admitted as a party, including the Department.</text> </paragraph> <paragraph num="(7)"> <text>“Person” means any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any firm, partnership, association, corporation, or other entity including any public or municipal corporation and any agency, bureau, department, or instrumentality of federal, State, or local government.</text> </paragraph> <paragraph num="(8)"> <text>“Secretary” means the Secretary of Health, a designee of the Secretary, or that official empowered by statute to render the final agency decision in a contested case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Sanctions."> <text>This chapter shall be construed to secure the just and speedy determination of each action. If a party fails to follow this chapter, the ALJ or the Secretary may enter such orders in regard to the failure as are just, including limiting the issues to be heard and dismissing the request for hearing or entering an order on the merits against the Department.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="The Record."> <text>The record in each case shall include:</text> <paragraph num="A."> <text>The items listed in COMAR 28.02.01.22B; and</text> </paragraph> <paragraph num="B."> <text>In the case of a proposed decision:</text> <paragraph num="(1)"> <text>Any exceptions filed by any party;</text> </paragraph> <paragraph num="(2)"> <text>The response to those exceptions;</text> </paragraph> <paragraph num="(3)"> <text>The final decision; and</text> </paragraph> <paragraph num="(4)"> <text>Any correspondence relating to the proposed decision, the exceptions process, and the final decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Notice of the Right to a Hearing."> <text>The Department shall provide the notices of agency action and of the right to a hearing required by law. The notices shall contain the information required by State Government Article, §§10-207 and 10-208, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Request for Hearing."> <paragraph num="A."> <text>A person, either directly or through a representative, may request a hearing by mailing or delivering a written request via U.S. mail, facsimile, or electronic mail to the individual and unit of the Department specified in the notice</text> </paragraph> <paragraph num="B."> <text>The request shall state that the person desires a hearing in order to review a matter that is the proper subject of a hearing as provided under Department regulations or other applicable law. In addition, the person requesting the hearing shall enclose a copy of the notice of agency action being appealed.</text> </paragraph> <paragraph num="C."> <text>The request shall include a brief statement of the basis for the request, and other information required by law.</text> </paragraph> <paragraph num="D."> <text>The Department or constituent unit may require a statement to be made on a form if the person is notified of this requirement and is provided a copy of the form in the notice of the right to a hearing.</text> </paragraph> <paragraph num="E."> <text>A request for a hearing shall be deemed filed when received in the unit of the Department specified in the notice required by Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Delegation."> <paragraph num="A."> <text>Contested cases that are authorized by statute to be conducted by the Secretary or the Department shall be conducted by:</text> <paragraph num="(1)"> <text>OAH in accordance with a letter of delegation from the Secretary; or</text> </paragraph> <paragraph num="(2)"> <text>Such other person as authorized by law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In all cases delegated to OAH, the delegation is limited to the issues raised by the notice of agency action attached to the transmittal from the agency to OAH.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Service."> <text>When the Department is required to make service, service may be made in any manner reasonably calculated to provide the required notice to the intended recipient. Service upon a party who has applied for a permit, license, or certificate or to whom a permit or license or certificate has been issued by the Department may be made by delivering a copy to the last known address in the Department’s records.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Certificates of Service."> <text>Whenever a party is required by this chapter to serve a copy of a pleading or memorandum upon another party, a certificate shall be appended to the pleading or memorandum stating:</text> <paragraph num="A."> <text>To whom the copy was sent;</text> </paragraph> <paragraph num="B."> <text>The address to which the copy was sent;</text> </paragraph> <paragraph num="C."> <text>The name of the person who sent the copy; and</text> </paragraph> <paragraph num="D."> <text>The date the copy was sent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Continuances."> <paragraph num="A."> <text>On motion or on the Secretary’s own initiative, an exceptions hearing may be continued by the Secretary as justice may require.</text> </paragraph> <paragraph num="B."> <text>Requests for postponement shall be confirmed in writing, and the written request shall:</text> <paragraph num="(1)"> <text>Set forth the reason for the request; and</text> </paragraph> <paragraph num="(2)"> <text>Unless the parties agree to schedule beyond the 45-day period, list at least three dates within the 45-day period following the day originally scheduled on which the party and counsel would be available for a hearing.</text> </paragraph> <paragraph num="(3)"> <text>Whenever feasible, a postponed hearing shall be rescheduled within the 45-day period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Time Periods."> <text>For good cause, either the Secretary or the ALJ may shorten, extend, or waive any time periods provided in this chapter.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appointment of Interpreter."> <paragraph num="A."> <text>If a party cannot readily hear, speak, or understand the spoken English language, the Secretary may appoint a qualified interpreter to provide assistance during an exceptions hearing.</text> </paragraph> <paragraph num="B."> <text>Costs of an interpreter may be charged to the party on whose behalf the interpreter is obtained.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Appearance of Parties at Hearings; Representation."> <paragraph num="A."> <text>A party to a proceeding may be represented by an attorney, or, if allowed by law, appear in person or through another representative.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided by law, a person other than an individual shall be represented by an attorney authorized to practice law in the State.</text> </paragraph> <paragraph num="C."> <text>Unless the appearance is subsequently withdrawn in writing, any notice, decision, or other matter required to be sent to a party may be sent to the attorney at the attorney’s address.</text> </paragraph> <paragraph num="D."> <text>When any party is represented by counsel, all submission of evidence, examination, and cross-examination of witnesses, and all objections and motions on its behalf shall be made solely by counsel.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Discovery."> <paragraph num="A."> <text>Discovery on Request. By written request filed with OAH and served on other parties at least twenty days before the scheduled hearing, a party may require another party to produce, within 15 calendar days:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; and</text> </paragraph> <paragraph num="(3)"> <text>The name and curriculum vitae of any expert who will testify at the hearing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Parties are not entitled to discovery of items other than as listed in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Open Hearings."> <paragraph num="A."> <text>Unless otherwise provided by law, documents, notices, and records in the possession of the Secretary as a result of these contested case proceedings may be inspected by any person as provided in State Government Article, §10-611 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Cameras and other photographic equipment may be permitted in the exceptions hearing room at the discretion of the Secretary.</text> </paragraph> <paragraph num="C."> <text>The Secretary may cause the removal of any person whose conduct impedes the orderly progress of an exceptions hearing, or may recess the hearing until such time as it may proceed in an orderly fashion.</text> </paragraph> <paragraph num="D."> <text>The Secretary may exclude from an exceptions hearing a person or persons who have given the Secretary no advance notice of an intention to attend, if the size of the hearing room is too small to accommodate the presence of that person or persons.</text> </paragraph> <paragraph num="E."> <text>An exceptions hearing is open to public observation, except for the parts that the Secretary states are to be closed pursuant to a provision of law expressly authorizing that closure. To the extent that a hearing is conducted by telephone, television, or other electronic means, the availability of public observation is satisfied by giving members of the public an opportunity, at reasonable times, to hear the tape recordings, except for such portions of the hearing as are closed pursuant to this section.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Burden of Going Forward and Persuasion."> <paragraph num="A."> <text>When, by specific statute or regulation, the burden of going forward or the burden of persuasion rests upon a certain party, this regulation does not shift those burdens.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §A of this regulation:</text> <paragraph num="(1)"> <text>A party requesting a hearing following notice of the Department’s intent to deny or refuse to renew a permit or license bears the burden of going forward to establish a prima facie case of entitlement to the permit or license and the burden of persuasion that the permit or license should be issued;</text> </paragraph> <paragraph num="(2)"> <text>A party contesting the Department’s tentative decision to issue or renew a permit or license bears the burden of going forward to establish a prima facie case that grounds exist for denying the license or permit and the burden of persuasion that the license or permit should be denied;</text> </paragraph> <paragraph num="(3)"> <text>In a proceeding following notice by the Department of an intent to revoke or suspend a permit or license, the Department bears the burden of going forward to establish a prima facie case as to the existence of grounds for revocation or suspension and the burden of persuasion that the license or permit should be revoked or suspended;</text> </paragraph> <paragraph num="(4)"> <text>In a proceeding to impose a civil penalty or to issue an order, the Department bears the burden of going forward to establish a prima facie case as to existence of the grounds for imposition of a civil penalty or issuance of an order and the burden of persuasion that the civil penalty should be imposed or order issued; and</text> </paragraph> <paragraph num="(5)"> <text>In a proceeding in which a party seeks payment from the Department or contests the recoupment by the Department of an alleged overpayment, the party seeking payment or contesting recoupment has burden of going forward and the burden of persuasion.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided by §§A and B of this regulation, the party asserting the affirmative of an issue before the ALJ has the burden of going forward and the burden of persuasion.</text> </paragraph> <paragraph num="D."> <text>A party with the burden of persuasion shall be required to present its case first, unless otherwise agreed by the parties.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Final Decision."> <paragraph num="A."> <text>The Secretary is not bound by the ALJ’s proposed decision even in those cases where no exceptions are filed.</text> </paragraph> <paragraph num="B."> <text>If no exceptions have been filed and, after reviewing an ALJ’s proposed decision, the Secretary concludes that the Secretary is unable to approve that decision as written, the Secretary shall notify all parties and invite argument from the affected parties on the issues the Secretary is reconsidering.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Exceptions; Requests for Oral Argument."> <paragraph num="A."> <text>Exceptions to an ALJ’s proposed decision shall be filed with the Secretary within 21 days after the ALJ’s proposed decision is received. Receipt is presumed to occur 3 days after mailing.</text> </paragraph> <paragraph num="B."> <text>Exceptions shall be in writing and contain a concise statement as to each portion of the ALJ’s determination to which exception is taken and the asserted basis for taking the exception.</text> </paragraph> <paragraph num="C."> <text>Any party may file a written response to exceptions taken to the ALJ’s proposed decision within 14 days of the filing of exceptions.</text> </paragraph> <paragraph num="D."> <text>A copy of the exceptions and any response shall be served on all parties to the proceedings.</text> </paragraph> <paragraph num="E."> <text>The Secretary shall hear oral argument on the exceptions and may limit the time for oral argument in the discretion of the Secretary.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall consider the exceptions filed before rendering the final agency decision.</text> </paragraph> <paragraph num="G."> <text>A party that intends to refer to any evidence produced at the hearing before the ALJ shall notify the agency of the specific evidence in its request for exceptions. That party is responsible for filing with the Secretary a copy of the transcript of the hearing, or relevant portions of it, at that party’s expense, at least 5 days before the scheduled exception hearing.</text> </paragraph> <paragraph num="H."> <text>If all parties are in agreement, a stipulation of facts may be submitted instead of a transcript.</text> </paragraph> <paragraph num="I."> <text>Additional evidence may not be introduced, nor may testimony of witnesses be heard by the Secretary. All exception hearings or reviews shall be conducted on the basis of the record compiled before the ALJ.</text> </paragraph> <paragraph num="J."> <text>Within 90 days after the conclusion of the exceptions hearing, the Secretary shall adopt a final decision and, if appropriate, an order. Copies of the final decision and findings of fact and conclusions of law shall be delivered or mailed promptly to all parties or to their attorneys.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Stays."> <paragraph num="A."> <text>Except as prohibited by law, a party that is adversely affected by a final order may request a stay of the order from the Secretary pending judicial review.</text> </paragraph> <paragraph num="B."> <text>A request for a stay shall be filed with the Secretary within 10 days of the date of the final order from which the stay is sought.</text> </paragraph> <paragraph num="C."> <text>A request shall include a statement of the reasons a stay is sought.</text> </paragraph> <paragraph num="D."> <text>A request shall include a statement of the grounds for the appeal to the Board of Review or the petition for judicial appeal.</text> </paragraph> <paragraph num="E."> <text>The Secretary may grant a stay upon such conditions, including security or bond, as the Secretary determines to be proper.</text> </paragraph> <paragraph num="F."> <text>A request for stay may not operate as a stay, nor extend the time for appeal.</text> </paragraph> <paragraph num="G."> <text>The Secretary may hold a hearing on a request for a stay, or rule upon the request without a hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Judicial Review."> <text>Unless otherwise agreed between the parties, a party may not file a petition for the judicial review of a decision of the Secretary unless the party has filed exceptions with the Secretary to the proposed decision and the Secretary has rendered a final decision. This provision does not apply when the Secretary has delegated final decision-making authority to OAH.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b); State Government Article, §§9-1607.2(b) and 10-206(b); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 31, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 repealed and new Regulations .01—.38 adopted effective February 6, 1989 (16:2 Md. R. 158)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.38 repealed and new Regulations .01—.20 adopted effective April 13, 2015 (42:7 Md. R. 567)</annotation> </annotations> </chapter> <chapter num="04" heading="Fair Hearing Appeals Under the Maryland State Medical Assistance Program"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland, to adjudicate contested cases at the Maryland Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Action by an MCO” means:</text> <paragraph num="(a)"> <text>Denial or limited authorization of a requested service, including:</text> <paragraph num="(i)"> <text>The type or level of service;</text> </paragraph> <paragraph num="(ii)"> <text>Requirements for medical necessity;</text> </paragraph> <paragraph num="(iii)"> <text>Appropriateness;</text> </paragraph> <paragraph num="(iv)"> <text>Setting; or</text> </paragraph> <paragraph num="(v)"> <text>Effectiveness of a covered benefit;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Reduction, suspension, or termination of a previously authorized service;</text> </paragraph> <paragraph num="(c)"> <text>Denial, in whole or part, of payment for a service;</text> </paragraph> <paragraph num="(d)"> <text>Failure to provide services in a timely manner;</text> </paragraph> <paragraph num="(e)"> <text>Failure to act within the required time frames; or</text> </paragraph> <paragraph num="(f)"> <text>The denial of an enrollee’s request to dispute a financial liability, including:</text> <paragraph num="(i)"> <text>Cost sharing;</text> </paragraph> <paragraph num="(ii)"> <text>Copayments;</text> </paragraph> <paragraph num="(iii)"> <text>Premiums;</text> </paragraph> <paragraph num="(iv)"> <text>Deductibles;</text> </paragraph> <paragraph num="(v)"> <text>Coinsurance; or</text> </paragraph> <paragraph num="(vi)"> <text>Other enrollee financial liabilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L. 111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L. 112-56).</text> </paragraph> <paragraph num="(4)"> <text>“Appellant” means any individual who requests a fair hearing for the reasons specified in Regulation .02 of this chapter or that individual’s authorized representative.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized representative” has the same meaning as in Regulation .12.</text> </paragraph> <paragraph num="(6)"> <text>“Consolidated Services Center” means a call center operated by the Maryland Health Benefit Exchange to assist consumers who apply for, or participate in, Insurance Affordability Programs offered through the Maryland Health Connection.</text> </paragraph> <paragraph num="(7)"> <text>“Delegate agency” means the:</text> <paragraph num="(a)"> <text>Department of Human Services and its affiliated local departments which, under contractual agreements with the Department, determine initial and continuing eligibility in the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Maryland Health Benefit Exchange and its designated affiliates.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health, the single state agency which, pursuant to Title XIX of the Social Security Act, implements fair hearing requirements for Program applicants and recipients.</text> </paragraph> <paragraph num="(9)"> <text>“Insurance affordability program” means a program that is one of the following:</text> <paragraph num="(a)"> <text>The Maryland State Medicaid program;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium;</text> </paragraph> <paragraph num="(c)"> <text>A State basic health program established under §1331 of the Affordable Care Act;</text> </paragraph> <paragraph num="(d)"> <text>A program that makes available to eligible individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; and</text> </paragraph> <paragraph num="(e)"> <text>A program that makes available to eligible individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI-based insurance affordability programs, including, by delegation, certain eligibility in the Program.</text> </paragraph> <paragraph num="(11)"> <text>“Maryland Health Connection” means the electronic eligibility system maintained by the Maryland Health Benefit Exchange.</text> </paragraph> <paragraph num="(12)"> <text>“MCO” means a managed care organization qualified to participate in the Program under COMAR 10.67.04.</text> </paragraph> <paragraph num="(13)"> <text>“Program" means the Department’s Medical Assistance Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Opportunity for a Fair Hearing."> <paragraph num="A."> <text>An opportunity for a fair hearing shall be granted if:</text> <paragraph num="(1)"> <text>A Program applicant claims their application for Program eligibility is denied;</text> </paragraph> <paragraph num="(2)"> <text>A Program applicant claims that the determination of eligibility received through Maryland Health Connection is incorrect;</text> </paragraph> <paragraph num="(3)"> <text>A Program applicant claims their application for eligibility, or any part thereof, is not acted upon within:</text> <paragraph num="(a)"> <text>30 days from the date of application to an insurance affordability program;</text> </paragraph> <paragraph num="(b)"> <text>45 days from the date of application for aged or blind applicants to the Program; or</text> </paragraph> <paragraph num="(c)"> <text>60 days from the date of application to the Program in the case of determination of disability;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Program recipient asserts their claim for Program services has been erroneously denied or is not acted upon with reasonable promptness;</text> </paragraph> <paragraph num="(5)"> <text>A Program recipient asserts that the Program has acted erroneously;</text> </paragraph> <paragraph num="(6)"> <text>A Program recipient residing in a skilled nursing facility or nursing home asserts that the recipient has been or will be erroneously transferred or discharged;</text> </paragraph> <paragraph num="(7)"> <text>A Program recipient asserts that the Program has made an erroneous decision related to nursing home preadmission and annual review; or</text> </paragraph> <paragraph num="(8)"> <text>A Program participant in an MCO is appealing an action by an MCO and the appeal has been filed within 120 days from the date specified in the notice from the MCO as required by COMAR 10.67.09.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The administrative law judge may not grant a fair hearing if the sole issue is a federal or State law requiring an automatic change adversely affecting some or all Program recipients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notification of Right to Request a Fair Hearing."> <paragraph num="A."> <text>The Program, delegate agency, or MCO shall notify an individual and his or her authorized representative, if previously designated by the individual or recognized as valid by the Program, in writing:</text> <paragraph num="(1)"> <text>Of the right to obtain a fair hearing;</text> </paragraph> <paragraph num="(2)"> <text>Of the method to obtain the hearing; and</text> </paragraph> <paragraph num="(3)"> <text>That the individual may represent himself or use an authorized representative at a fair hearing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The notification specified in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Be provided by the Program, the MCO, or the delegate agency when:</text> <paragraph num="(a)"> <text>The individual applies for Program benefits;</text> </paragraph> <paragraph num="(b)"> <text>Any Program, MCO, or delegate agency action affects the individual’s claim to Program benefits;</text> </paragraph> <paragraph num="(c)"> <text>A skilled nursing facility or a nursing facility notifies the individual that the individual is to be transferred or discharged; and</text> </paragraph> <paragraph num="(d)"> <text>The individual receives an adverse determination by the Department or delegate agency with regard to skilled nursing facility or a nursing facility preadmission screening and annual resident review;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Include a statement of the action the Program, MCO, skilled nursing facility, or nursing facility intends to take;</text> </paragraph> <paragraph num="(3)"> <text>Include the reasons for the intended action;</text> </paragraph> <paragraph num="(4)"> <text>Include the specific regulations that support, or the change in federal or State law that requires, the action;</text> </paragraph> <paragraph num="(5)"> <text>Include an explanation of the individual’s right to request a fair hearing, including that expenses incurred in connection with a fair hearing, such as transportation and baby-sitting costs, but not including attorney's fees, shall be paid by the Department when incurred by the appellant and may be paid by the Department when incurred by the appellant's witnesses;</text> </paragraph> <paragraph num="(6)"> <text>Include information about fair hearings;</text> </paragraph> <paragraph num="(7)"> <text>Include an explanation of the circumstances under which assistance is continued if a fair hearing is requested, as provided in Regulation .04B of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Identify who may act as an authorized representative of the appellant in the fair hearing process, explain how an applicant or recipient may designate an authorized representative, and provide information about designation procedures under 10.09.04.12;</text> </paragraph> <paragraph num="(9)"> <text>Specify that the appellant or the appellant’s authorized representative may generally examine the appellant’s records upon reasonable notice to the Program, MCO, or delegate agency; and</text> </paragraph> <paragraph num="(10)"> <text>Except as specified in §C of this regulation, be mailed at least 10 days before the date of action.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice specified in §A of this regulation may be mailed less than 10 days before but not later than the date of action if:</text> <paragraph num="(1)"> <text>The Program has information confirming the recipient’s death;</text> </paragraph> <paragraph num="(2)"> <text>The Program receives a clear written statement signed by a recipient that:</text> <paragraph num="(a)"> <text>The recipient no longer wishes services; or</text> </paragraph> <paragraph num="(b)"> <text>Gives information that requires termination or reduction of services and indicates that the recipient understands that this change in services is the result of supplying that information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The recipient has been admitted to an institution where the recipient is ineligible under the Program for further services;</text> </paragraph> <paragraph num="(4)"> <text>Subject to Regulation .10B(4) of this chapter, the recipient's whereabouts are unknown and the post office returns to the Program or delegate agency mail directed to the recipient indicating no forwarding address;</text> </paragraph> <paragraph num="(5)"> <text>The Program establishes that the recipient has been accepted for Program services by another local jurisdiction, State, territory, or commonwealth;</text> </paragraph> <paragraph num="(6)"> <text>The recipient's physician prescribes a change in the level of care;</text> </paragraph> <paragraph num="(7)"> <text>The notice involves an adverse determination made with regard to preadmission screening requirements;</text> </paragraph> <paragraph num="(8)"> <text>The date of action will occur in less than 10 days and the action involves a long-term care facility’s resident transfer or discharge, in which case the notification shall be made as soon as practicable before transfer or discharge in accordance with 42 CFR §438.12;</text> </paragraph> <paragraph num="(9)"> <text>The Program has facts indicating that action should be taken because of probable fraud by the recipient and the facts have been verified, if possible, through secondary sources, in which case the notification may be mailed 5 days before the date of action; or</text> </paragraph> <paragraph num="(10)"> <text>The action is an eligibility determination, in which case notice shall be given at the same time as the determination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Request for Fair Hearing."> <paragraph num="A."> <text>Statement of Request.</text> <paragraph num="(1)"> <text>Any individual, either himself or through an authorized representative, may request a fair hearing by giving a clear statement, oral, electronic, or written, to any member of the Department or delegate agency, that the individual desires an opportunity to present for review any matter which is the proper subject of a fair hearing as provided in Regulation .02 of this chapter. The request shall be made by:</text> <paragraph num="(a)"> <text>Contacting the Program’s Office of Health Services in writing, by telephone or by fax, if the appeal concerns a recipient’s services being denied, suspended, terminated, or reduced;</text> </paragraph> <paragraph num="(b)"> <text>Contacting the Maryland Health Benefits Exchange in writing, by telephone, by email, or by fax, if the appeal concerns an applicant’s eligibility for insurance affordability programs;</text> </paragraph> <paragraph num="(c)"> <text>Contacting the Consolidated Services Center maintained by the Maryland Health Benefit Exchange in writing, by telephone, by email, or by fax, if the appeal concerns eligibility for insurance affordability programs; or</text> </paragraph> <paragraph num="(d)"> <text>Contacting the Office of Administrative Hearings in person, by mail, or by fax, if the appeal concerns the appellant’s eligibility for insurance affordability programs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Program’s Office of Health Services, the Consolidated Services Center, or the delegate agency that receives the request for a hearing shall assist the appellant or the appellant’s authorized representative in preparing the request.</text> </paragraph> <paragraph num="(3)"> <text>The Program's Office of Health Services, the Consolidated Services Center, or the delegate agency that receives a written statement requesting an appeal shall:</text> <paragraph num="(a)"> <text>Immediately forward an applicant’s statement to the Office of Administrative Hearings;</text> </paragraph> <paragraph num="(b)"> <text>Indicate whether the appeal is for a determination of eligibility under an insurance affordability program or for conventional Medicaid; and</text> </paragraph> <paragraph num="(c)"> <text>Note in its correspondence with the Office of Administrative Hearings if the appeal:</text> <paragraph num="(i)"> <text>Concerns the medical necessity of a denied benefit or service to an MCO enrollee or an application for eligibility insurance affordability programs;</text> </paragraph> <paragraph num="(ii)"> <text>Meets the Program’s criteria for an expedited resolution because the Program has determined that taking the time for a standard resolution could seriously jeopardize the individual’s life or health or ability to attain, maintain, or regain maximum function; and</text> </paragraph> <paragraph num="(iii)"> <text>Must be heard and decided upon within 3 working days after the Office of Administrative Hearings receives the fair hearing request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Appeals of eligibility determinations for insurance affordability programs requested through the Maryland Health Connection shall automatically be transmitted to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(5)"> <text>If a request for a hearing is made by someone other than the applicant or recipient, the Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Treat the appeal as timely noted if it complies with §D of this regulation unless no documentation is provided on or before the hearing date;</text> </paragraph> <paragraph num="(b)"> <text>Accept appropriate documentation, up to and including the date of the fair hearing, demonstrating that the representative is authorized; and</text> </paragraph> <paragraph num="(c)"> <text>Accept the representation of any member of the bar of Maryland that the individual appellant is his or her client without further documentation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Acknowledgement. The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Promptly acknowledge any request for a fair hearing;</text> </paragraph> <paragraph num="(2)"> <text>Give advance notice in writing of the date, time, and place of the fair hearing; and</text> </paragraph> <paragraph num="(3)"> <text>Provide the appellant with the information specified in Regulation .03B of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Postponements.</text> <paragraph num="(1)"> <text>If any party notifies the Office of Administrative Hearings that either the time or place designated by the Office of Administrative Hearings is not convenient to the party, and requests a different time or place for the fair hearing, the administrative law judge shall designate another time or place convenient to the parties if the administrative law judge deems that the party has sufficient reason for requesting the change.</text> </paragraph> <paragraph num="(2)"> <text>If the appellant is employed during the periods when fair hearings are normally held, the administrative law judge shall attempt to schedule the hearing so that the appellant will not be required to miss employment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Timeliness of Appeal. A request for a fair hearing may not be granted unless the request in §A of this regulation is:</text> <paragraph num="(1)"> <text>Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 120 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied by an MCO;</text> </paragraph> <paragraph num="(2)"> <text>Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 90 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied by the fee-for-service program; or</text> </paragraph> <paragraph num="(3)"> <text>Postmarked, delivered in person, or sent by facsimile to the Office of Administrative Hearings; or emailed to Maryland Health Benefit Exchange; telephoned or faxed to the Consolidated Services Center or postmarked, telephoned, faxed, or delivered in person to the delegate agency within 90 days of the receipt of the notification specified in Regulation .03A of this chapter if the appeal concerns the appellant’s eligibility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Dismissal.</text> <paragraph num="(1)"> <text>The Program, the delegate agency, or the Office of Administrative Hearings may dismiss a request for a fair hearing when the appeal has been:</text> <paragraph num="(a)"> <text>Withdrawn in writing addressed to the Office of Administrative Hearings, or in writing, by telephone, or by fax to the Office of Health Services, or in writing, by telephone, or electronically to the Maryland Health Benefit Exchange or other delegate agency, by the appellant or his authorized representative; or</text> </paragraph> <paragraph num="(b)"> <text>Abandoned.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An appellant shall be deemed to have abandoned the appellant’s request for a fair hearing if the appellant fails to appear for the fair hearing on the established date without good cause as determined by the administrative law judge.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Program’s Response. In responding to timely filed requests for a fair hearing, the Office of Administrative Hearings:</text> <paragraph num="(1)"> <text>May respond to a series of individual requests for hearing by conducting a single group hearing;</text> </paragraph> <paragraph num="(2)"> <text>May consolidate hearings only in cases in which the sole issue involved is one of federal or State law or policy;</text> </paragraph> <paragraph num="(3)"> <text>Shall follow the regulations of this chapter governing hearings in all group hearings; and</text> </paragraph> <paragraph num="(4)"> <text>Shall permit each applicant to present the appellant’s own case or be represented by the appellant’s authorized representative.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Pre-Hearing Procedures."> <paragraph num="A."> <text>A hearing summary shall be prepared containing pertinent information detailing the specific action that is the basis for the appeal. The summary shall be forwarded to the appellant or the appellant’s authorized representative and to the Office of Administrative Hearings at least 6 days before the hearing date.</text> </paragraph> <paragraph num="B."> <text>The appellant and the Department or MCO may request the names of all witnesses that the other party intends to call at the fair hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Hearing Procedures."> <paragraph num="A."> <text>The appellant, the Program, the MCO, and the delegate agency shall have the opportunity to:</text> <paragraph num="(1)"> <text>Present witnesses;</text> </paragraph> <paragraph num="(2)"> <text>Present documentary evidence;</text> </paragraph> <paragraph num="(3)"> <text>Present oral and written argument without undue interference;</text> </paragraph> <paragraph num="(4)"> <text>Establish all facts and circumstances the administrative law judge judges to be pertinent; and</text> </paragraph> <paragraph num="(5)"> <text>Question or refute any testimony or evidence, including an opportunity to confront and cross-examine all witnesses the administrative law judge judges to be adverse.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All parties that wish to call a witness at the hearing shall subpoena the witness in accordance with Office of Administrative Hearings procedures in COMAR 28.02.01.11. The appellant or authorized representative may subpoena any employees of the Department, MCO, or delegate agency whose action is being contested by the appellant or whose testimony may be relevant to the issues under consideration as determined by the administrative law judge.</text> </paragraph> <paragraph num="C."> <text>Right to Review Record.</text> <paragraph num="(1)"> <text>If the Program, MCO, or delegate agency introduces as evidence documents from the case record, special investigation file, or other sources, the appellant shall have the opportunity to examine the:</text> <paragraph num="(a)"> <text>Persons who prepared the documents; and</text> </paragraph> <paragraph num="(b)"> <text>Case record or special investigation file for the purpose of discovering information favorable to the appellant’s case.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as specified in Regulation .05A of this chapter, in addition to the rights specified in §C(1) of this regulation and for purposes of defining reasonable notice under Regulation .03B(9) of this chapter, the appellant or the appellant’s authorized representative shall have the opportunity to examine the appellant’s case record or investigation file upon reasonable notice to the Program, the MCO, or the delegate agency as specified in COMAR 07.01.02.04.</text> </paragraph> <paragraph num="(3)"> <text>The Program shall have access to relevant portions of the appellant’s medical record in accordance with Health-General Article, §4-305, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When a hearing involves a medical issue, such as a diagnosis, an examining physician's report or a medical review team's decision, an additional medical assessment of the appellant's condition shall be obtained and made part of the record if the administrative law judge considers it necessary. Any additional medical assessment shall be made by a person other than the person who made the original medical assessment and shall be obtained at the Department's expense.</text> </paragraph> <paragraph num="E."> <text>The delegate agency shall be a party to the fair hearing if the fair hearing involves an issue of eligibility.</text> </paragraph> <paragraph num="F."> <text>Appeal for an Individual Enrolled in an MCO.</text> <paragraph num="(1)"> <text>The parties to the appeal for an individual enrolled in an MCO include the MCO, the enrollee, and the enrollee’s representative or the personal representative of a deceased enrollee’s estate.</text> </paragraph> <paragraph num="(2)"> <text>If the appeal concerns the medical necessity of a denied, reduced, suspended, or terminated benefit or service to an MCO enrollee, and if the fair hearing meets the Department-established criteria for an expedited hearing as provided in Regulation .04A(3)(b)(ii) of this chapter, the Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Schedule the hearing and render a bench decision within 3 working days after the Office of Administrative Hearings receives the fair hearing request; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a follow-up written decision within 30 days of rendering the bench decision if the Office of Administrative Hearings, the appellant or the appellant’s authorized representative, and the MCO agree that a written decision is necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All other appeals from MCO decisions shall be:</text> <paragraph num="(a)"> <text>Scheduled for a hearing within 30 days of receipt of the appeal and decided on within 30 days of the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>Otherwise governed by COMAR 10.67.09.05.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="The Record."> <paragraph num="A."> <text>A verbatim recording of the fair hearing shall be made. Nonrecorded or confidential information, which the appellant does not have an opportunity to hear or see, may not be made a part of the hearing record. One transcribed copy of the recording shall be supplied to the appellant at no cost if the appellant takes a further appeal.</text> </paragraph> <paragraph num="B."> <text>The following shall constitute the exclusive record of the hearing:</text> <paragraph num="(1)"> <text>The transcript or recording of testimony and exhibits, or an official report containing the substance of what happened at the hearing;</text> </paragraph> <paragraph num="(2)"> <text>All papers and requests filed in the proceeding; and</text> </paragraph> <paragraph num="(3)"> <text>The administrative law judge’s decision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The recording of testimony shall remain in the custody of the Office of Administrative Hearings for a period not to exceed 2 years, or until all litigation involving the decision is terminated. All other components of the record shall remain in the custody of the Program for a period not to exceed 2 years, or until all litigation involving the decision is terminated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Findings, Timing of Decision, and Effect of Decision."> <paragraph num="A."> <text>Findings.</text> <paragraph num="(1)"> <text>The administrative law judge shall:</text> <paragraph num="(a)"> <text>Prepare a written summary of findings and conclusions based exclusively on the record; and</text> </paragraph> <paragraph num="(b)"> <text>Make a decision based on his findings and conclusions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The summary of findings and conclusions shall:</text> <paragraph num="(a)"> <text>State the evidence, policies, regulations, or laws upon which the administrative law judge's decision is based; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the appellant that, if they are not satisfied with the decision, they may seek additional appeals as specified in §C of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Timing of Hearing Decision.</text> <paragraph num="(1)"> <text>If the appellant is not enrolled in an MCO, the administrative law judge shall forward to the appellant a copy of the findings, conclusions, and decision within 90 days from the earlier of the following:</text> <paragraph num="(a)"> <text>The date the appellant postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services a request for a fair hearing pursuant to Regulation .04D(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The date the appellant postmarked, delivered in person, or sent by facsimile to the Office of Administrative Hearings or the delegate agency a request for a fair hearing pursuant to Regulation .04D(2) of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>The date the appellant emailed, postmarked or delivered in person to the Maryland Health Benefit Exchange a request for a fair hearing pursuant to Regulation .04D(2) of this chapter; or</text> </paragraph> <paragraph num="(d)"> <text>The date the appellant called or sent by facsimile to the Consolidated Services Center a request for a fair hearing pursuant to Regulation .04D(2) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the appellant is enrolled in an MCO, the administrative law judge shall forward to the appellant or the appellant’s authorized representative a copy of the findings, conclusions, and decision within:</text> <paragraph num="(a)"> <text>3 working days after the Office of Administrative Hearings receives the fair hearing request if the appeal concerns the medical necessity of a denied benefit or service, and the hearing that meets the criteria, as determined by the Department, for an expedited hearing as provided in Regulation .04A(3)(b)(ii) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>30 days of the hearing if the appeal does not concern the medical necessity of a denied benefit or service.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the date of the fair hearing is postponed at the appellant's request, the length of the postponement may not be counted as part of any of the time periods specified in §B(1) or (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Appeal Rights.</text> <paragraph num="(1)"> <text>Any party may seek administrative review of the administrative law judge’s decision as provided in Health-General Article, §§2-206 and 2-207, Annotated Code of Maryland, and subsequent judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland, except if the appeal is solely of a decision of the Maryland Health Benefit Exchange, in which case any party may seek judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>An administrative law judge’s decision adverse to the appellant shall be implemented immediately.</text> </paragraph> <paragraph num="(3)"> <text>To the extent an administrative law judge’s decision upholds the determination of the Maryland Health Benefit Exchange with respect to an applicant for an insurance affordability program described in Regulation .01B(9)(a)—(e), the applicant may appeal to the United States Department of Health and Human Services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Effect of Decision.</text> <paragraph num="(1)"> <text>When the decision requires action by the delegate agency, that agency shall notify the Program of its compliance with the decision.</text> </paragraph> <paragraph num="(2)"> <text>When the decision is favorable to the appellant, or when the Department, Program, or delegate agency grants the appellant the relief the appellant requests before the decision, the Department, Program, or delegate agency, where applicable, shall:</text> <paragraph num="(a)"> <text>Authorize corrected payments or relief retroactive to the date the incorrect action was taken; and</text> </paragraph> <paragraph num="(b)"> <text>If appropriate, provide for admission or readmission of the appellant to a facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Any payment or action by the Department, Program, or delegate agency in §D(2) of this regulation may not constitute a waiver of the Department’s, Program’s or delegate agency’s sovereign immunity from suit.</text> </paragraph> <paragraph num="(4)"> <text>When the decision is favorable to the appellant and is an MCO service, the MCO shall authorize or provide the disputed services no later than 72 hours from the date it receives notice reversing the MCO’s determination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Confidentiality."> <paragraph num="A."> <text>If the appellant waives in writing his privilege of confidentiality as to the fair hearing, the administrative law judge shall permit members of the public to attend the hearing.</text> </paragraph> <paragraph num="B."> <text>The administrative law judge may cause the removal of any member of the public whose conduct impedes the orderly progress of the hearing, or recess the hearing until it may proceed in orderly fashion.</text> </paragraph> <paragraph num="C."> <text>The administrative law judge may exclude from the hearing individuals who have not given the Department or MCO advance notice of their intention to attend if the size of the hearing room is too small to accommodate them.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Benefits During Appeals Process."> <paragraph num="A."> <text>Benefits Pending Outcome of the Hearing.</text> <paragraph num="(1)"> <text>The Program may terminate or reduce services effective as of the date specified in the notice if the Program timely mails the notice as required under Regulation .03 of this chapter and:</text> <paragraph num="(a)"> <text>The appellant or the appellant’s authorized representative does not timely request a hearing in accordance with Regulation .04 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The appellant or the appellant’s authorized representative withdraws in writing or abandons a request for a fair hearing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §A(3) of this regulation, the Program may not terminate or reduce services until a decision is rendered after the hearing if:</text> <paragraph num="(a)"> <text>The Program timely mails the notice as required under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The appellant requests a hearing before the date specified in the notice.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Program may terminate or reduce services before an administrative law judge renders a decision after a hearing if:</text> <paragraph num="(a)"> <text>The administrative law judge determines at the hearing that the sole issue is one of federal or State law or policy, or the request for a fair hearing is withdrawn in writing or abandoned; and</text> </paragraph> <paragraph num="(b)"> <text>The Program includes in the notification required by Regulation .03 of this chapter that services are to be terminated or reduced pending the hearing decision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The MCO shall continue benefits pending the outcome of the State fair hearing as described in COMAR 10.67.09.05F.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstating Benefits.</text> <paragraph num="(1)"> <text>If the Program terminates or reduces services pursuant to §A of this regulation, the Program may reinstate services if a Program recipient requests a hearing not more than 10 days after the date specified in the notice.</text> </paragraph> <paragraph num="(2)"> <text>The reinstated services shall continue until a hearing decision, unless, at the hearing, the administrative law judge determines that the sole issue is one of federal or State law or policy.</text> </paragraph> <paragraph num="(3)"> <text>The Program shall reinstate and continue services until a decision is rendered after a hearing if:</text> <paragraph num="(a)"> <text>Action is taken without the advance notice being given to the recipient as required by Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The recipient requests a hearing within 10 days of the mailing of the notice; and</text> </paragraph> <paragraph num="(c)"> <text>The Program determines that the action resulted from other than the application of federal or State law or policy.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a recipient's whereabouts are unknown, as indicated by the return of unforwardable Program mail directed to the recipient, any discontinued services shall be reinstated if the recipient’s whereabouts become known during the time the recipient is eligible for services.</text> </paragraph> <paragraph num="(5)"> <text>The administrative law judge may provide for an additional period during which time the request for a fair hearing will result in reinstatement of a recipient’s assistance to be continued until the hearing decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Applicability of Regulations."> <text>If a conflict exists between this chapter and the Rules of Procedure of the Office of Administrative Hearings in COMAR 28.02.01, this chapter shall govern.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Authorized Representatives."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>“Authorized representative” means an individual or organization acting responsibly on behalf of the applicant or recipient in accordance with §§B, C, D, and E of this regulation, in assisting with an applicant or recipient’s application, renewal of eligibility, appeals, and other ongoing communications with the agency.</text> </paragraph> <paragraph num="(2)"> <text>“Signature” includes electronic, including telephonically recorded, signatures and handwritten signatures transmitted by facsimile or other electronic transmissions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Designating an Authorized Representative.</text> <paragraph num="(1)"> <text>An applicant or recipient may designate any individual or organization to serve as an authorized representative.</text> </paragraph> <paragraph num="(2)"> <text>An authorized representative may be designated either:</text> <paragraph num="(a)"> <text>In writing, including the applicant or recipient’s signature; or</text> </paragraph> <paragraph num="(b)"> <text>By providing proof of legal authority to act on behalf of an applicant or recipient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Legal authority includes, but is not limited to those who are the:</text> <paragraph num="(a)"> <text>Applicant or, if applicant or recipient is a minor, recipient’s parent;</text> </paragraph> <paragraph num="(b)"> <text>Applicant or recipient’s legal guardian, if one has been appointed, or a person who has in good faith filed an application to be appointed the applicant or recipient’s legal guardian but who has not yet been appointed the applicant or recipient’s legal guardian;</text> </paragraph> <paragraph num="(c)"> <text>Applicant or recipient’s healthcare surrogate as defined in Health General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>Personal representative of the applicant or recipient’s estate, or a person who has in good faith filed an application to be appointed the personal representative of the applicant or recipient’s estate but who has not yet been appointed the personal representative of the applicant or recipient’s estate;</text> </paragraph> <paragraph num="(e)"> <text>Individual appointed to make legal or medical decisions on behalf of the applicant or recipient pursuant to a validly executed power of attorney; or</text> </paragraph> <paragraph num="(f)"> <text>Attorney or paralegal retained by the individual.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For individuals who lack the capacity to designate an authorized representative and for whom no other individual or organization has the legal authority to act under §B(2) of this regulation, an authorized representative can be any individual or organization acting responsibly on behalf of the applicant or recipient who:</text> <paragraph num="(a)"> <text>In good faith, is acting in the best interest of the applicant or recipient; and</text> </paragraph> <paragraph num="(b)"> <text>Declares the applicant or recipient lacks legal capacity, and for organizations, declares that its directors, employees, officers or employers, if any, do not have a direct financial interest in the outcome of the fair hearing.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For individuals who lack the capacity to designate an authorized representative, for whom no other individual or organization has the legal authority to act under §B(2) of this regulation, and on behalf of whom no individual or organization covered by §B(4) of this regulation is willing and able to act, an authorized representative can be any individual or organization with a direct financial interest in the outcome of the hearing or whose employer has a direct financial interest in the outcome of the hearing who:</text> <paragraph num="(a)"> <text>In good faith is acting in the best interest of the applicant or recipient;</text> </paragraph> <paragraph num="(b)"> <text>Declares that the applicant or recipient lacks legal capacity; and</text> </paragraph> <paragraph num="(c)"> <text>Declares that to the best of his or her belief, no other individual or organization is willing and able to act on the applicant or recipient’s behalf.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Time for Authorization. Designation of an authorized representative or the declarations by an individual or organization required under §B(4) and (5) of this regulation to become an authorized representative can take place at any time, including, but not limited to, the time of application, upon redetermination, upon filing an appeal, and at the appeal hearing.</text> </paragraph> <paragraph num="D."> <text>Validity of Representation. The power to act as an authorized representative is valid until the applicant or recipient modifies the authorization or notifies the agency that the representative is no longer authorized to act on his or her behalf, or the authorized representative informs the agency that the authorized representative is no longer acting in such capacity, or there is a change in the legal authority upon which the individual or organization’s authority was based. This notice shall be in writing and shall include the applicant or recipient’s signature or the authorized representative’s signature as appropriate.</text> </paragraph> <paragraph num="E."> <text>Powers of Authorized Representative. Authorized representatives may be authorized to:</text> <paragraph num="(1)"> <text>Sign an application on the applicant’s behalf;</text> </paragraph> <paragraph num="(2)"> <text>Complete and submit an update, a renewal form, or respond to a request for redetermination;</text> </paragraph> <paragraph num="(3)"> <text>Receive copies of the applicant or recipient’s notice and other communications from the agency; and</text> </paragraph> <paragraph num="(4)"> <text>Act on behalf of the applicant or recipient in all matters with the agency including appeals.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Obligations of the Authorized Representative. An authorized representative:</text> <paragraph num="(1)"> <text>Is responsible for fulfilling all the responsibilities encompassed within the scope of the authorized representation as described in §E of this regulation to the same extent as the individuals the authorized representative represents; and</text> </paragraph> <paragraph num="(2)"> <text>Shall agree to maintain, or be legally bound to maintain, the confidentiality of any information regarding the applicant or recipient provided by the agency.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Authorized Representatives Through an Organization. A provider, staff member or volunteer of an organization shall sign an agreement that he or she will adhere to the federal regulations governing authorized representatives as laid out in 42 CFR §435.923 or 45 CFR §155.227, or both, as well as relevant State and federal laws concerning conflicts of interest and confidentiality of information.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104 and 15-103, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 1, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulations .01C, .03C, 04A and C, .05A, .06B and D, .07B, .08, .09, .10 amended effective January 14, 1985 (12:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04D and .08B amended effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 19, 2012 (39:5 Md. R. 382)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 15, 2013 (40:7 Md. R. 610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 22, 2018 (45:21 Md. R. 973); May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 15, 2013 (40:7 Md. R. 610); May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, C amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2162)</annotation> </annotations> </chapter> <chapter num="05" heading="Board of Review Procedures" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 27, 1972</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective August 3, 1981 (8:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 3, 1981 (8:15 Md. R. 1306); February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.10 adopted effective October 15, 2001 (28:20 Md. R. 1782)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 2, 2018 (45:13 Md. R. 664)</annotation> </annotations> </chapter> <chapter num="06" heading="Fair Hearing Appeals under the Special Supplemental Food Program for Women, Infants, and Children (WIC)"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>“Appellant” means an individual, an applicant agency, a food vendor, or delegate agency who desires to participate in the WIC Program, who requests a fair hearing for the reasons specified in Regulation .02, of this chapter.</text> </paragraph> <paragraph num="B."> <text>“Applicant agency” means a public or private, non-profit health or welfare agency providing or contracting to provide health services, which has filed with the Department all the information required by the Department to apply to participate in the WIC Program.</text> </paragraph> <paragraph num="C."> <text>“Delegate agency” means a local agency or organization which, pursuant to contractual agreements with the Department, has accepted responsibilities under the WIC Program as defined by federal program regulations.</text> </paragraph> <paragraph num="D."> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="E."> <text>“Food vendor” means an individual or organization licensed to sell food products, who has, or has applied to have, a contractual agreement with the Department or delegate agency to supply approved foods to program recipients.</text> </paragraph> <paragraph num="F."> <text>“Hearing officer” means an impartial official designated by the Secretary of Health to conduct and make administrative decisions in fair hearings. The hearing officer may not have had any prior connection with the action which is the subject of the fair hearing.</text> </paragraph> <paragraph num="G."> <text>“Participant” means pregnant women, breastfeeding women, post-partum women, infants, and children who are receiving supplemental foods or food instruments (benefits) under the WIC Program, and the breastfed infants of participant breastfeeding women.</text> </paragraph> <paragraph num="H."> <text>“State Agency” means that unit of the Maryland Department of Health which is responsible for the administration and operation of the WIC Program in Maryland.</text> </paragraph> <paragraph num="I."> <text>“WIC” means the Special Supplemental Food Program for Women, Infants, and Children, a federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental nutritious food as an adjunct to good health care during critical times of growth and development to prevent the occurrence of health problems.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Opportunity for a Fair Hearing."> <text>A request for a fair hearing shall be granted in the following cases:</text> <paragraph num="A."> <text>An individual's application for participation in the WIC Program is denied by the Department or delegate agency;</text> </paragraph> <paragraph num="B."> <text>An eligible participant is required to pay the cash value of improperly issued benefits, or is denied benefits, suspended or terminated from the WIC Program by the Department or delegate agency;</text> </paragraph> <paragraph num="C."> <text>An applicant agency, delegate agency, or food vendor's:</text> <paragraph num="(1)"> <text>Application to participate in the WIC program is denied by the State or local agency,</text> </paragraph> <paragraph num="(2)"> <text>Participation in the WIC program is suspended or terminated by the State or local agency,</text> </paragraph> <paragraph num="(3)"> <text>Participation in the WIC program is affected by any other adverse action by the State or local agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notification of Right to Request a Fair Hearing."> <paragraph num="A."> <text>Written notification of the right to obtain a fair hearing shall be given by the Department or delegate agency to each appellant at each time of application.</text> </paragraph> <paragraph num="B."> <text>Written notification of the right to obtain a fair hearing, and the method of obtaining the hearing, shall be given by the Department or delegate agency whenever it notifies an appellant that it intends to recover the cash value of the improperly issued benefits or to deny, suspend, or terminate participation in the WIC Program. If benefits or eligibility for an individual or food vendor are to be denied, suspended, or terminated, written notice shall be mailed or given at least 15 days before the effective date. In the case of a delegate agency, the notice shall be provided 60 days in advance of the effective date. This notification is not required at the expiration of a certification period.</text> </paragraph> <paragraph num="C."> <text>The notification specified in §B, of this regulation, shall give the appellant the following information:</text> <paragraph num="(1)"> <text>The reason for the action which may adversely affect him or his benefits;</text> </paragraph> <paragraph num="(2)"> <text>The matters which are the proper subject of a fair hearing as provided in Regulation .02, of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Any positions or arguments on his behalf may be presented personally or by a representative such as a relative, friend, or legal counsel;</text> </paragraph> <paragraph num="(4)"> <text>The circumstances under which assistance is continued if a fair hearing is requested, as provided in Regulation .02, of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Request for Fair Hearing."> <text>An appellant, either himself or through a representative, may request a fair hearing by giving a clear statement, oral or written, to any member of the State WIC Staff or delegate agency, that he desires an opportunity to present for review any matter which is the proper subject of a fair hearing as provided in Regulation .02, of this chapter. The statement shall be forwarded immediately to the hearing officer. The State WIC staff or delegate agency to whom a request for a hearing is made shall assist the appellant in submitting and processing the request.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Acknowledgement of Request."> <paragraph num="A."> <text>The Department shall promptly acknowledge a request for a fair hearing and conduct it within 3 weeks from the date the Department received the request for a hearing.</text> </paragraph> <paragraph num="B."> <text>The appellant shall be given notice, in writing, at least 10 days before the date of the fair hearing.</text> </paragraph> <paragraph num="C."> <text>The notification specified in §B, of this chapter, shall include the following information:</text> <paragraph num="(1)"> <text>The date, time, and place of the fair hearing;</text> </paragraph> <paragraph num="(2)"> <text>His right to be represented by a lawyer or other person of his choice during the fair hearing process;</text> </paragraph> <paragraph num="(3)"> <text>His right to present witnesses and documents in his behalf at the fair hearing;</text> </paragraph> <paragraph num="(4)"> <text>A summary of rules for a fair hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Redesignation of Time and Place for Hearing."> <text>If a party notifies the Department that either the time or place designated by the Department is not convenient and requests a different time or place for the fair hearing, the hearing officer shall designate another time or place convenient to the parties, if he considers that the party has sufficient reason for requesting the change. If the appellant is employed during the periods when fair hearings are normally held, the hearing officer shall schedule the hearing so that the appellant will not be required to miss employment.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Period of Time for Requesting Hearing."> <text>A request for a fair hearing may not be granted unless it is made within 60 days from the date the notification specified in Regulation .03, of this chapter, is mailed or given to the appellant, or when Regulation .03, of this chapter, does not apply, within 60 days following the conclusion of the action or inaction which is the subject of the appeal.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Dismissal of Request for Hearing."> <text>The Department may dismiss a request for a fair hearing if:</text> <paragraph num="A."> <text>It has been withdrawn in writing by the appellant or his representative;</text> </paragraph> <paragraph num="B."> <text>The appellant or his representative fails, without good cause, to appear at the scheduled hearing;</text> </paragraph> <paragraph num="C."> <text>The appellant or his representative does not respond within 10 days to a Department letter asking whether he wishes to withdraw his request for a fair hearing;</text> </paragraph> <paragraph num="D."> <text>The request is not made within the time limits specified in Regulation .07, of this chapter; or</text> </paragraph> <paragraph num="E."> <text>The appellant has been denied participation by a previous hearing and cannot provide evidence that circumstances relevant to program eligibility have changed in such a way as to justify a hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Pre-Hearing Procedures."> <paragraph num="A."> <text>The Department shall prepare a hearing summary containing pertinent information respecting the specific action or inaction which is the basis for the appeal. The summary shall be forwarded to the appellant or his representative at least 6 days before the hearing date, and shall include notification that the appellant or his representative may examine documents and records to be used at the hearing at the office of the hearing officer, at a reasonable time before the date of hearing.</text> </paragraph> <paragraph num="B."> <text>The appellant and the Department may request the names of all witnesses that the other party intends to call at the fair hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Hearing Procedures."> <paragraph num="A."> <text>The fair hearing procedures may not be unduly complex or legalistic. The hearing official shall administer oaths or affirmations as required by the State. The appellant, the Department, and the delegate agency shall have the opportunity to present witnesses, documentary evidence, and oral and written argument, and to cross-examine all adverse witnesses. The appellant will have the opportunity to advance arguments without undue interference.</text> </paragraph> <paragraph num="B."> <text>If the appellant wishes to call as witnesses employees of the Department or delegate agency whose action or inaction is being contested by the appellant, or whose testimony, in the judgment of the hearing officer, is relevant to the issues under consideration, the hearing officer shall require their presence at the fair hearing, provided that, when the appellant has knowledge of the names or other identifying description of these employees before the fair hearing, he shall supply the hearing officer with the names or other identifying descriptions at least 3 days before the fair hearing.</text> </paragraph> <paragraph num="C."> <text>If the Department or delegate agency introduces documents as evidence, the appellant shall have the opportunity to examine persons who prepared the documents and to examine the case record or special investigation file for the purpose of discovering information favorable to his case.</text> </paragraph> <paragraph num="D."> <text>When the hearing involves medical issues, an additional medical assessment of the appellant's condition shall be obtained and made part of the record if either the hearing officer or the appellant considers it necessary. This additional medical assessment shall be made by a person satisfactory to the appellant other than the person or persons who made the original medical determination, and shall be obtained at the Department's expense.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="The Record."> <paragraph num="A."> <text>A verbatim recording of the fair hearing shall be made. One transcribed copy of the recording shall be supplied to the appellant, at no cost, if the appellant takes a further appeal. The recording, together with all exhibits and papers admitted into evidence, shall constitute the exclusive record for decision. Nonrecorded or confidential information which the appellant does not have an opportunity to hear or see may not be made a part of the hearing record. The written record of the hearing shall be preserved for a period of 3 years and shall be available for examination by the person or his representative at any reasonable time or place during this period.</text> </paragraph> <paragraph num="B."> <text>The recording and copies of all exhibits and papers shall remain in the custody of the hearing officer for at least 3 years, or until all litigation involving the decision is terminated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Findings, Conclusions, and Decision."> <paragraph num="A."> <text>The hearing officer shall prepare a written summary of findings and conclusions based exclusively on the record, and shall state the policies, regulations, or laws upon which the hearing officer's decision is based. The hearing officer's decision shall become a part of the record.</text> </paragraph> <paragraph num="B."> <text>A copy of the findings, conclusions, and decision shall be forwarded to the appellant or his representative no later than 45 days after the date of receipt of the initial request for a fair hearing; except that, if the date of the fair hearing is postponed at the appellant's request, the length of the postponement may not be counted as part of the 45-day period. The hearing officer further shall provide written notice to the appellant or his representative that if he is not satisfied with the decision, he may seek administrative review as provided in Health-General Article, §2-207, Annotated Code of Maryland, and judicial review as provided in Article 41, §225, Annotated Code of Maryland, or any other provision of law.</text> </paragraph> <paragraph num="C."> <text>The decision of the hearing officer shall be final and binding upon the Department and the delegate agency, and shall be implemented immediately unless otherwise specifically indicated in the decision, or unless the appellant takes an appeal as provided in Health-General Article, §2-207, Annotated Code of Maryland. However, if the decision being appealed is in favor of a delegate agency seeking to recover the cash value of improperly issued benefits, the delegate agency shall resume its claim collection efforts during pendency of the appeal. When the decision requires action by the delegate agency, that agency shall notify the Department of compliance with the decision.</text> </paragraph> <paragraph num="D."> <text>The hearing officer shall maintain a copy of the decision, with the name of the appellant and witnesses deleted, in a reference file or hearing decisions that will be accessible to the public. Copies of all decisions, either in full text or in summary form, shall be forwarded to the delegate agency and any agency or physician with which it has contracted to fulfill its program responsibilities and is involved in this fair hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Confidentiality as to Fair Hearings."> <text>If the appellant waives in writing his privilege of confidentiality as to the fair hearings, the hearing officer shall permit members of the public to attend the hearing; however, the hearing officer may cause the removal of any member of the public whose conduct impedes the orderly progress of the hearings, or may recess the hearings until a time when it may proceed in orderly fashion. The hearing officer also may exclude from the hearing persons who have given the Department no advance notice of their intention to attend, if the size of the hearing room is too small to accommodate them.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Continuation of Benefits or Participation Pending Hearing Decision."> <paragraph num="A."> <text>Whenever an individual, applicant agency, delegate agency, or food vendor is notified of a proposed action as provided in Regulation .03, of this chapter, the proposed action may not be taken unless at least one of the following occurs:</text> <paragraph num="(1)"> <text>A fair hearing is not requested in a timely manner, as provided by Regulation .07, of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A request for a fair hearing has been withdrawn in writing by the appellant or a representative;</text> </paragraph> <paragraph num="(3)"> <text>The appellant or representative fails, without good cause, to appear at the scheduled hearing;</text> </paragraph> <paragraph num="(4)"> <text>The appellant or representative, after failing to appear at a scheduled hearing, does not respond within 10 days to a departmental letter asking whether the appellant wishes to continue with the appeal;</text> </paragraph> <paragraph num="(5)"> <text>A decision affirming the proposed action of the Department or delegate agency is made by the hearing officer following a fair hearing;</text> </paragraph> <paragraph num="(6)"> <text>The Department has made a determination that the request for a fair hearing is not appropriate as provided for by Regulation .02, of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Whenever an eligible participant is notified during a certification period that benefits are to be denied, suspended, or terminated, those benefits will continue to be provided if the participant requests a fair hearing within the 15 day advance notice period provided by Regulation .03B, of this chapter. Those benefits will continue until one of the conditions specified in Regulation .14A, of this chapter, occurs.</text> </paragraph> <paragraph num="C."> <text>Whenever an eligible participating food vendor is notified that participation is to be denied, suspended, terminated, or affected by any other adverse action, the food vendor shall be allowed to continue to participate if the food vendor requests a fair hearing at least 10 days before the effective date of the proposed adverse action. Participation shall continue until one of the conditions specified in §A, of this chapter, occurs.</text> </paragraph> <paragraph num="D."> <text>Applicants who are denied benefits at initial certification or at subsequent certifications may appeal the denial but may not receive benefits while awaiting a hearing.</text> </paragraph> <paragraph num="E."> <text>An applicant agency or food vendor which is denied participation at time of application may appeal the denial but may not participate while awaiting a hearing.</text> </paragraph> <paragraph num="F."> <text>Whenever an eligible participant, participating delegate agency, or food vendor requests a fair hearing following the expiration of the time period as provided in §§B and C, of this regulation, the hearing officer, in his discretion, may provide an additional period during which time a request for a fair hearing shall result in continuation of benefits or participation until one of the conditions specified in §A, of this regulation, occurs.</text> </paragraph> <paragraph num="G."> <text>The adverse action affecting a participating delegate agency shall be postponed until a hearing decision is reached.</text> </paragraph> <paragraph num="H."> <text>Appealing an action does not relieve a delegate agency or food vendor permitted to continue in the program while its appeal is in process from the responsibility of continued compliance with the terms of any written agreement or contract with the State or local agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Criminal or Civil Sanctions."> <text>This fair hearing procedure may not be construed as excluding or replacing any criminal or civil sanctions or other remedies that may be applicable under any federal or State statute or local ordinance.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104; State Government Article, §10-215; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 2, 1977 (4:3 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 3, 1978 (5:22 Md. R. 1673); July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective August 22, 1980 (7:17 Md. R. 1672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E amended effective August 22, 1980 (7:17 Md. R. 1672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01G amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 3, 1978 (5:22 Md. R. 1673); July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective June 26, 1981 (8:13 Md. R. 1138)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective March 24, 1986 (13:6 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 7, 1980 (7:5 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 7, 1980 (7:5 Md. R. 474); July 18, 1983 (10:14 Md. R. 1262); March 24, 1986 (13:6 Md. R. 682); January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 22, 1980 (7:17 Md. R. 1672); July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 3, 1978 (5:22 Md. R. 1673); August 22, 1980 (7:17 Md. R. 1672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 26, 1981 (8:13 Md. R. 1138); April 12, 1982 (9:7 Md. R. 711); July 18, 1983 (10:14 Md. R. 1262); October 24, 1983 (10:21 Md. R. 1901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective March 24, 1986 (13:6 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 3, 1978 (5:22 Md. R. 1673); March 7, 1980 (7:5 Md. R. 474); July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective March 7, 1980 (7:5 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D adopted effective July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E adopted effective March 24, 1986 (13:6 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective June 26, 1981 (8:13 Md. R. 1138)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective June 26, 1981 (8:13 Md. R. 1138)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective April 12, 1982 (9:7 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective March 7, 1980 (7:5 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective March 24, 1986 (13:6 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14D adopted effective July 18, 1983 (10:14 Md. R. 1262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E—H adopted effective March 24, 1986 (13:6 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective November 3, 1978 (5:22 Md. R. 1673)</annotation> </annotations> </chapter> <chapter num="07" heading="Petitions for Adoption, Amendment, or Repeal of Regulations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all petitions submitted to the Department to promulgate, amend, or repeal a regulation over which the Secretary has rulemaking authority in accordance with State Government Article, §10-122, Annotated Code of Maryland..</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Petition” means a petition to promulgate, amend, or repeal a regulation.</text> </paragraph> <paragraph num="(3)"> <text>“Petitioner” means an interested person filing a petition to the Department to promulgate, amend, or repeal a regulation.</text> </paragraph> <paragraph num="(4)"> <text>“Regulation” has the meaning stated in State Government Article, §10-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Who May File."> <text>Any interested person may file a petition requesting the promulgation, amendment, or repeal of any regulation over which the Secretary has rulemaking authority.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Form and Submission of Petition."> <paragraph num="A."> <text>A petition shall be in writing and include:</text> <paragraph num="(1)"> <text>A detailed description of the regulation which the petitioner requests the Department to promulgate, amend, or repeal;</text> </paragraph> <paragraph num="(2)"> <text>If a request for amendment or repeal, a citation to the affected regulation;</text> </paragraph> <paragraph num="(3)"> <text>A statement in support of the petition; and</text> </paragraph> <paragraph num="(4)"> <text>The petitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Signature;</text> </paragraph> <paragraph num="(c)"> <text>Address; and</text> </paragraph> <paragraph num="(d)"> <text>Telephone number.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A petition shall be submitted by the petitioner to the Director of the Department’s Office of Regulation and Policy Coordination via email or U.S. Mail.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disposition and Notification Requirements."> <paragraph num="A."> <text>Disposition of Petition. Within 60 days after receipt of a petition, the Secretary shall:</text> <paragraph num="(1)"> <text>Deny the petition; or</text> </paragraph> <paragraph num="(2)"> <text>Initiate rulemaking proceedings.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notification Requirements.</text> <paragraph num="(1)"> <text>If the Secretary denies the petition, the Secretary shall provide in writing the reason for denial in accordance with Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary initiates rulemaking proceedings, the Secretary shall provide in writing notification to the petitioner:</text> <paragraph num="(a)"> <text>Upon the intent to initiate rulemaking proceedings;</text> </paragraph> <paragraph num="(b)"> <text>Upon publication of the proposed action in the Maryland Register; and</text> </paragraph> <paragraph num="(c)"> <text>Upon final disposition through either publication of a notice of final action in the Maryland Register or discontinuation of rulemaking.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Secretary discontinues rulemaking proceedings the written notification provided to the petitioner in accordance with §B(2) of this regulation shall state the reasons for discontinuation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall provide the written notification required under §B of this regulation to any other individual requesting notification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reasons for Denial of a Petition."> <text>The Secretary may deny a petition for any reason permitted by law, including, but not limited to:</text> <paragraph num="A."> <text>That the Secretary does not have the authority to grant the petition;</text> </paragraph> <paragraph num="B."> <text>That the Department does not have adequate information or resources to evaluate the petition;</text> </paragraph> <paragraph num="C."> <text>That the Department does not have adequate resources to implement the requested regulation if it is adopted;</text> </paragraph> <paragraph num="D."> <text>That the Secretary previously adopted a regulation dealing with the same subject matter as that of the petition and rejected the position taken by petitioner at that time, or the petitioner unreasonably failed to make his position known at that time; or</text> </paragraph> <paragraph num="E."> <text>That the requested regulation change is contrary to or inconsistent with Departmental policy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rulemaking Proceedings."> <paragraph num="A."> <text>Rulemaking proceedings may include any type of action which the Secretary is authorized or required by law to take when promulgating, amending, or repealing regulations, including:</text> <paragraph num="(1)"> <text>Studies to gather information concerning the regulation;</text> </paragraph> <paragraph num="(2)"> <text>Advance notice of proposed rulemaking if the Secretary determines that additional information or public comment is necessary or desirable before a proposed regulation can be formulated;</text> </paragraph> <paragraph num="(3)"> <text>Referral to advisory councils or other official or quasi-official agencies or groups responsible for reviewing the regulation;</text> </paragraph> <paragraph num="(4)"> <text>Proposal of the regulation in the Maryland Register;</text> </paragraph> <paragraph num="(5)"> <text>Reproposal of the regulation if the Secretary determines that, before final adoption, the proposed regulation should be altered and any part of the proposed text differs substantively from its original text; or;</text> </paragraph> <paragraph num="(6)"> <text>Modification of the regulation change either in form or in substance, and either before or after proposal in the Maryland Register, to better reflect the Secretary's responsibilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Despite the initiation of rulemaking proceedings, the Secretary may decide not to promulgate, amend, or repeal the regulation.</text> </paragraph> <paragraph num="C."> <text>Upon final disposition, the Secretary shall provide the notification required to the petitioner in accordance with Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Files of Petitions for Regulations."> <text>The Department shall maintain a file of all petitions submitted and their disposition. This file shall be available for public inspection in accordance with General Provisions Article, §§4-201—4-206, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §§10-122 and 10-123; Health-General Article, §2-104; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 9, 1981 (8:22 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 23, 1989 (16:1 Md. R. 69); December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 23, 1989 (16:1 Md. R. 69); December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 2, 2026 (53:4 Md. R. 184)</annotation> </annotations> </chapter> <chapter num="08" heading="Procedures for Access to Records"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes the procedures for requesting and gaining access to records and information of the Maryland Department of Health , its administrations, and its facilities.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to requests for medical records of individuals, which are governed by Health-General Article, §4-301 et seq., Annotated Code of Maryland, or to requests for drug and alcohol treatment records of individuals, which are governed by Health-General Article, §8-601, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means any person or governmental unit requesting disclosure of public records.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Official custodian” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(4)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Working day” means every day except Saturdays, Sundays, and official State holidays.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Procedures Regarding Inspection or Copying of a Record."> <paragraph num="A."> <text>To obtain access to records of the Department, an applicant shall submit to the custodian a written application containing the applicant's name, address, telephone number, if available, and a description of the record sought. If the applicant is an individual with a disability, the Department may arrange for an alternative.</text> </paragraph> <paragraph num="B."> <text>Upon receipt of an application, the custodian shall follow the procedures stated in State Government Article, §§10-614—10-619, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Response to Requests.</text> <paragraph num="(1)"> <text>The custodian shall respond to a record request as soon as possible, but not later than 10 business days after the receipt of the request, by:</text> <paragraph num="(a)"> <text>Providing access to the requested records;</text> </paragraph> <paragraph num="(b)"> <text>Denying access to the record or parts of the record with an explanation for the denial; or</text> </paragraph> <paragraph num="(c)"> <text>Advising that additional time is needed because the request:</text> <paragraph num="(i)"> <text>Is for voluminous records;</text> </paragraph> <paragraph num="(ii)"> <text>Requires legal advice; or</text> </paragraph> <paragraph num="(iii)"> <text>A record is in storage or archived.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a requested record has been destroyed or lost, the custodian shall notify the applicant of this fact within 10 working days of the request and shall explain in the response the circumstances of the destruction or loss.</text> </paragraph> <paragraph num="(3)"> <text>If access cannot be provided within 10 business days, the custodian shall:</text> <paragraph num="(a)"> <text>Cite the reasons why more time is needed; and</text> </paragraph> <paragraph num="(b)"> <text>Provide a good-faith estimate of how much additional time is required to fulfill the request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Time and Place of Inspection.</text> <paragraph num="(1)"> <text>An applicant may inspect a record between 8 a.m. and 5 p.m. on a working day.</text> </paragraph> <paragraph num="(2)"> <text>Inspection takes place where the document is located, unless the custodian determines that another location is more suitable.</text> </paragraph> <paragraph num="(3)"> <text>The custodian shall arrange for a suitable location and method of inspection for an individual with a disability.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Fees."> <paragraph num="A."> <text>Fee Schedule.</text> <paragraph num="(1)"> <text>Copies.</text> <paragraph num="(a)"> <text>When copies are reproduced using a computer printer or copier machine, the charge for each copy is 50 cents per page.</text> </paragraph> <paragraph num="(b)"> <text>For duplication of other storage media such as compact disks, magnetic tapes, zip disks, floppy disks, memory cards, microfilm, blueprints, drawings, and similar items the charge for reproduction is the actual cost to the Department.</text> </paragraph> <paragraph num="(c)"> <text>For preprinted material that is disseminated by the Department to the public, there is no charge or the charge is the same as that charged to the general public.</text> </paragraph> <paragraph num="(d)"> <text>For records that cannot be copied by the Department and that are copied outside the Department, the charge for reproduction is the actual cost to the Department. In the alternative, the custodian may arrange for the applicant to pay the charges directly to the entity that copies the record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Certification of Copies. The additional charge for each copy certified as a true copy of the original is 20 cents per page.</text> </paragraph> <paragraph num="(3)"> <text>Employee Time. Except for the first 2 hours which are free, the standard charge for responding to requests for public information is $25 per hour of employee time. Employee time to respond to a request may include time searching for records, preparing records to be copied, copying records, and any other similar tasks.</text> </paragraph> <paragraph num="(4)"> <text>Mailing. The charge for mailing or delivery is the actual cost to the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Estimated Charges. Before reproducing a record, the custodian shall provide the applicant with an estimate of the charge for reproduction and any other costs, and obtain agreement from the applicant that the charges will be paid. The custodian may demand prepayment of the estimated charges before reproducing the record.</text> </paragraph> <paragraph num="C."> <text>Waiver of Charges. The custodian may waive charges for:</text> <paragraph num="(1)"> <text>Advocacy groups;</text> </paragraph> <paragraph num="(2)"> <text>Medicaid and WIC recipients; or</text> </paragraph> <paragraph num="(3)"> <text>Applicants who demonstrate need and good cause.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b); State Government Article, §§10-611—10-628; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1981 (8:20 Md. R. 1635)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .14 amended, .07 and .09 repealed, and new .07 adopted effective July 16, 1984 (11:14 Md. R. 1250)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 16, 1984 (11:14 Md. R. 1250); July 29, 1985 (12:15 Md. R. 1516); May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 29, 1985 (12:15 Md. R. 1516); May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1 adopted effective July 29, 1985 (12:15 Md. R. 1516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective August 17, 1992 (19:16 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14G amended effective May 15, 1989 (16:9 Md. R. 994)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 18, 2014 (41:16 Md. R. 945)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 18, 2002 (16:9 Md. R. 220)</annotation> </annotations> </chapter> <chapter num="09" heading="Procedures for Hearing Before the Hospital Appeal Board and Nursing Home Appeal Board"> <regulation prefix="Regulation" num=".01" heading="General."> <text>This chapter sets out the procedures for appeals of final cost settlements before the Hospital Appeal Board, pursuant to COMAR 10.09.92.10, 10.09.93.12, and 10.09.95.12, and the Nursing Home Appeal Board, pursuant to COMAR 10.09.10.34.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Hospital Appeal Board or the Nursing Home Appeal Board.</text> </paragraph> <paragraph num="(2)"> <text>“Final cost settlement” means a determination by the Medical Assistance Program of any amounts due to or owed by a participating provider and includes the results of cost verifications and desk reviews.</text> </paragraph> <paragraph num="(3)"> <text>“Party” means a hospital or nursing home or the Medical Assistance Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notice of Appeal."> <paragraph num="A."> <text>An opportunity for a hearing shall be provided to any hospital or nursing home that requests review of a final cost settlement by filing a written notice of appeals with the Board not later than 30 days after receipt of the notice of final cost settlement. This notice shall be filed in a format prescribed by the Board.</text> </paragraph> <paragraph num="B."> <text>The notice of appeal shall be delivered in person to the Board at the address designated by the notice of final cost settlement or shall be sent by registered or certified mail, return receipt requested.</text> </paragraph> <paragraph num="C."> <text>The notice of appeal shall describe with specificity the particular cost adjustments appealed by the provider as well as the fiscal years in which those adjustments have been applied.</text> </paragraph> <paragraph num="D."> <text>The provider may elect one of the following types of procedures:</text> <paragraph num="(1)"> <text>The consideration by the Board solely of written material submitted by the provider and the Medical Assistance Program, or its designee, and upon which the Board shall render a decision. The Board may establish time limits within which the material is to be submitted.</text> </paragraph> <paragraph num="(2)"> <text>The consideration by the Board of written material submitted by the provider and the Medical Assistance Program, or its designee, and brief, informal oral arguments. Each party may submit oral arguments by not more than two persons. Formal testimony, swearing in, or witnesses or recording of proceedings may not take place. The Board shall render a decision based upon the written materials submitted and the oral arguments presented.</text> </paragraph> <paragraph num="(3)"> <text>A full evidentiary hearing, including a prehearing conference, in accordance with Regulations .04, .05, and .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The procedures provided in §D(3) of this regulation will be followed if the Medical Assistance Program objects in writing to the election of a procedure provided for in §D(1) or (2) of this regulation within 10 working days of receipt of the election.</text> </paragraph> <paragraph num="F."> <text>The Board shall prescribe the format in which the provider may elect the type of procedure desired with the submission of an appeal. This election shall be binding and constitutes a waiver of any other form of hearing before the Board for that particular appeal unless the Medical Assistance Program objects in the manner provided in §E of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Conference for Evidentiary Hearing."> <paragraph num="A."> <text>After receipt of a notice of appeal with an election by the provider of a full evidentiary hearing, the Board shall schedule a prehearing conference.</text> </paragraph> <paragraph num="B."> <text>The prehearing conference shall be presided over by a member of the Board or by a person designated by the Board.</text> </paragraph> <paragraph num="C."> <text>The prehearing conference may be conducted either in person or by telephone conference call.</text> </paragraph> <paragraph num="D."> <text>The presiding officer shall issue a prehearing order after the conference specifying the:</text> <paragraph num="(1)"> <text>Witnesses that each party intends to call, if any.</text> </paragraph> <paragraph num="(2)"> <text>Schedule for any briefs of the issues of fact and law involved in the hearing. These briefs shall be in the form and with the number of copies designated by the presiding officer.</text> </paragraph> <paragraph num="(3)"> <text>Date of the hearing, unless the parties agree to waive an oral hearing.</text> </paragraph> <paragraph num="(4)"> <text>Order in which the parties shall present their case.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A record shall be made of the prehearing conference by the officer in charge.</text> </paragraph> <paragraph num="F."> <text>All prehearing matters, including requests for postponements, shall be addressed to and determined by the officer who presides at the prehearing conference.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Evidentiary Hearing."> <paragraph num="A."> <text>The hearing shall be conducted by the Board, or by a person or agency designated by the Board.</text> </paragraph> <paragraph num="B."> <text>The rules of evidence in all hearings shall be those set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions, and motions. When a party is represented by counsel, all submissions of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel.</text> </paragraph> <paragraph num="D."> <text>The presiding officer or officers at the hearing may examine any witness called by any party or may call as a witness any persons in attendance at the hearing.</text> </paragraph> <paragraph num="E."> <text>Testimony taken at the hearing shall be under oath. The oath shall be in the following form: “Do you solemnly promise and affirm under the penalties of perjury that the testimony you are about to give in this matter now pending before the Board shall be the truth, the whole truth, and nothing but the truth?”</text> </paragraph> <paragraph num="F."> <text>If a party fails to appear at the hearing after due notice, the presiding officer or officers at the hearing may reschedule the hearing, or dismiss the appeal, or may proceed to determine the issues appealed on the available record.</text> </paragraph> <paragraph num="G."> <text>The presiding officer or officers shall prepare an official record of the hearing which shall include the notice of appeal, the presiding officer or officers' record of the prehearing conference, the prehearing order, a stenographic transcription of any oral evidence presented at the hearing, as well as any pleadings, written testimony, exhibits, and other memoranda or materials filed in the proceedings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Recommendation to the Board."> <paragraph num="A."> <text>If the hearing is not conducted before a Board consisting of three members as provided in COMAR 10.09.10.34, 10.09.92.10, 10.09.93.12, and 10.09.95.12, the presiding officer or officers at the hearing shall issue recommendations to the Board on all of the issues appealed in the notice of appeal.</text> </paragraph> <paragraph num="B."> <text>The recommendations shall be in writing and shall include findings of fact and conclusions of law.</text> </paragraph> <paragraph num="C."> <text>A copy of the recommendations shall be delivered or mailed promptly to each party or his attorney of record.</text> </paragraph> <paragraph num="D."> <text>Within 20 days after receipt of the recommendations, any party may file exceptions with the Board from all or a portion of the recommendations and may present argument before the Board as provided in State Government Article, §10-216, Annotated Code of Maryland, or waive oral argument and have the Board proceed only on the party's written exceptions. If exceptions to the recommendations are filed beyond the 20 day limit, these exceptions may not be considered by the Board when making its decision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision."> <paragraph num="A."> <text>If the hearing was presided over by the full Board, or after consideration by the full Board of the recommendations and exceptions to the recommendations and any argument in support of them, the Board shall issue a decision including findings of fact and conclusions of law on all issues appealed in the notice of appeal.</text> </paragraph> <paragraph num="B."> <text>The decision of the Board shall be implemented immediately unless otherwise specifically indicated in the decision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeal."> <text>Any party may file an appeal from the decision of the Board as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-108, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 43)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 19, 2006 (33:12 Md. R. 997); July 2, 2018 (45:13 Md. R. 664)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 19, 2006 (33:12 Md. R. 997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective June 19, 2006 (33:12 Md. R. 997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 2, 2018 (45:13 Md. R. 664)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective June 19, 2006 (33:12 Md. R. 997)</annotation> </annotations> </chapter> <chapter num="10" heading="Payment for Off-Grounds Medical Services"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The Secretary of Health (MDH) has established accounts for the purpose of payment of off-grounds medical services. These accounts are to be used by MDH facilities whose clients receive services from private medical providers that the facility cannot furnish or secure by contract. The care could include laboratory work, services from medical specialties, and acute hospitalization. The care does not include ambulance transportation.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Client” means a resident or patient in a Maryland Department of Health facility.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>Facility.</text> <paragraph num="(a)"> <text>“Facility” means an inpatient or residential facility owned and operated by the Department.</text> </paragraph> <paragraph num="(b)"> <text>“Facility” includes Mental Administration institutions, Developmental Disabilities Administration institutions, and chronic and rehabilitation facilities.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Medical providers” means private providers of medical care or related services who render care to clients of the Department's facilities.</text> </paragraph> <paragraph num="(5)"> <text>“Off-grounds medical services” means medical care or related services provided to clients of the Department's facilities rendered by medical providers at a site other than the facility.</text> </paragraph> <paragraph num="(6)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements."> <paragraph num="A."> <text>All facilities shall provide or arrange for the provision of medical care required by individuals placed in Department facilities.</text> </paragraph> <paragraph num="B."> <text>All facilities shall purchase medical services that cannot be provided in the facility by the facility's staff or visiting consultants from providers appropriately licensed in the state in which the service is to be rendered.</text> </paragraph> <paragraph num="C."> <text>All facilities shall purchase medical services from medical providers who agree to invoice the facility only for those services that are not covered by third-party payers, including federal, state, or federal-state programs.</text> </paragraph> <paragraph num="D."> <text>The financial agents shall assist the provider in identifying potential sources of recovery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Payment Procedures."> <paragraph num="A."> <text>Medical providers shall collect to the extent possible from third-party payers such as Medical Assistance, Medicare, and private insurers.</text> </paragraph> <paragraph num="B."> <text>Facilities shall direct medical providers to invoice the facility for the cost of those services not covered by third-party payers. For Medical Assistance recipients, the Secretary or the Secretary's designee shall determine which services are specifically provided for in the facility's budget and are included in the facility's Medical Assistance per diem rate, and, therefore, may not be billed directly to the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="C."> <text>The purchase of care agreement entered into with the provider shall state that “The provider, in accepting this client for care, agrees to pursue recovery of the cost of care from all third-party payers and any state, federal, and federal-state program for which this client might be eligible, based on the information furnished by the facility before invoicing (name of facility).”</text> </paragraph> <paragraph num="D."> <text>Payment in Full.</text> <paragraph num="(1)"> <text>If a third-party source of payment is intended to be payment in full, the facility may accept but may not pay invoices for the service rendered, unless payment by the third-party source is denied.</text> </paragraph> <paragraph num="(2)"> <text>If a third-party source of payment is not intended to be payment in full, the facility shall pay the amount of the bill not paid by the third-party payer.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Medical providers shall submit all invoices to the appropriate facility within 12 months of the date of services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If a client has insurance or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the client for any service covered by this chapter, the medical provider shall seek payment from that source.</text> </paragraph> <paragraph num="B."> <text>Payment. If payment is made by both the facility and insurance or other payer, the following conditions apply:</text> <paragraph num="(1)"> <text>If the facility has paid all or part of the invoice and the third-party payer has made payment that represents payment in full, then the medical provider shall return the facility's entire payment to the facility;</text> </paragraph> <paragraph num="(2)"> <text>If the facility has paid the invoice in full and if the third-party payer has made payment that represents partial payment, then the medical provider shall return the amount of the third-party payment to the facility;</text> </paragraph> <paragraph num="(3)"> <text>If a third-party payer has made payment that is intended to be a partial payment and the facility has paid the remainder, then no repayment to the facility is required.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall reimburse the facility for any overpayment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §2-104(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective September 1, 1983 (10:20 Md. R. 1780); adopted permanently effective December 19, 1983 (10:25 Md. R. 2268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 20, 1989 (16:3 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective February 20, 1989 (16:3 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 20, 1993 (20:25 Md. R. 1946)</annotation> </annotations> </chapter> <chapter num="11" heading="Correction or Amendment of Public Records"> <regulation prefix="Regulation" num=".01" heading="General."> <text>These regulations set out procedures for persons in interest who are authorized to inspect a public record to request the correction or amendment of that public record in the Maryland Department of Health under State Government Article, §10-625, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Person in interest” means:</text> <paragraph num="(a)"> <text>A person or governmental unit that is the subject of a public record, or a designee of the person or governmental unit;</text> </paragraph> <paragraph num="(b)"> <text>If the person has a legal disability, the parent or legal representative of that person; or</text> </paragraph> <paragraph num="(c)"> <text>As to requests for correction of certificates of death under Health-General Article, §5-310(d)(2), Annotated Code of Maryland, the spouse, adult child, parent, adult sibling, grandparent, or guardian of the person of the deceased at the time of the deceased's death.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Who May Request."> <text>A person in interest may request the Department to correct or amend any public record that the person in interest is authorized to inspect pursuant to State Government Article, §10-625, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Contents of Request."> <text>The person in interest shall request the correction or amendment in writing. The request shall:</text> <paragraph num="A."> <text>Identify the public record the person is seeking to correct or amend;</text> </paragraph> <paragraph num="B."> <text>State the precise correction or amendment requested;</text> </paragraph> <paragraph num="C."> <text>State the reason the correction or amendment is sought; and</text> </paragraph> <paragraph num="D."> <text>Include the statement that the record is, to the person's belief, currently inaccurate or incomplete.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Filing the Request."> <text>A person shall file a request for correction or amendment of the record with the Department by addressing it to the custodian of the record. If the custodian is unknown to the person in interest, the person may address the request to the Secretary of Health.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Return of Nonconforming Request."> <paragraph num="A."> <text>The Department shall accept a request to correct or amend a public record when it is received if it complies with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>If the request does not comply with Regulations .04 and .05 of this chapter, the Department shall return the request to the requester with:</text> <paragraph num="(1)"> <text>An explanation of the reason for the return; and</text> </paragraph> <paragraph num="(2)"> <text>A statement that, on receipt of a request that complies with Regulations .04 and .05 of this chapter, the request will be accepted and considered.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Response to Request."> <text>Within 30 days after the request for correction or amendment is received, the custodian of the record shall:</text> <paragraph num="A."> <text>Make the requested correction or amendment and inform the person of the action;</text> </paragraph> <paragraph num="B."> <text>Inform the person in writing of the:</text> <paragraph num="(1)"> <text>Department's refusal to make the requested correction or amendment, and</text> </paragraph> <paragraph num="(2)"> <text>Reason for the refusal; or</text> </paragraph> </paragraph> <paragraph num="C."> <text>Inform the person in writing that the request will not be acted on because:</text> <paragraph num="(1)"> <text>The person is not a person in interest;</text> </paragraph> <paragraph num="(2)"> <text>The record sought to be corrected or amended is not a public record;</text> </paragraph> <paragraph num="(3)"> <text>The person requesting the correction or amendment is not entitled to inspect the record under State Government Article, §§10-615—10-619, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>The record in which the change is requested is not in the Department's custody; or</text> </paragraph> <paragraph num="(5)"> <text>Of any other reason that is authorized by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Refusal of Request."> <text>If the Department's response under Regulation .07 of this chapter, is to refuse the requested correction or amendment, the person in interest may file with the Department a concise statement of the person's reasons for:</text> <paragraph num="A."> <text>The requested correction or amendment; and</text> </paragraph> <paragraph num="B."> <text>Disagreement with the Department's refusal to make the correction or amendment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Requirements for Statement of Disagreement."> <text>A person who desires to file the statement of disagreement specified in Regulation .08 of this chapter shall file the statement in not more than five, one-sided, 8-1/2 by 11 inch pages.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Information Provided to Third Parties."> <text>When the Department discloses to a third party information from a public record about which a statement in compliance with Regulations .08 and .09 of this chapter has been filed, the Department shall furnish a copy of the statement to the third party.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Administrative Review."> <paragraph num="A."> <text>A person may request a hearing by filing a request for a hearing with the custodian of the record, if the person has been denied:</text> <paragraph num="(1)"> <text>An amendment or correction of a record;</text> </paragraph> <paragraph num="(2)"> <text>The right to file a statement of disagreement; or</text> </paragraph> <paragraph num="(3)"> <text>The right to have a statement to a third party forwarded pursuant to Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person shall file the request for a hearing within 30 days of the date of the denial pursuant to §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>The custodian of the record shall file immediately the request for a hearing with the Office of Administrative Hearings, which shall conduct the hearing.</text> </paragraph> <paragraph num="D."> <text>The Office of Administrative Hearings shall conduct hearing proceedings in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and the administrative hearing regulations of the Department and the Office of Administrative Hearings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Judicial Review."> <text>A person who is aggrieved by the final decision following all administrative review, including the final decision of the Secretary and the decision of the Board of Review, may file for judicial review under State Government Article, §10-222, Annotated Code of Maryland, by filing a petition in the appropriate circuit court.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b); State Government Article, §§10-613(b) and 10-625; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 8, 1985 (12:7 Md. R. 702)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 18, 2014 (41:16 Md. R. 946)</annotation> </annotations> </chapter> <chapter num="12" heading="Declaratory Ruling"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Declaratory ruling” means a ruling made by a promulgating authority with respect to the manner in which the promulgating authority would apply a regulation or order of the promulgating authority, or a statute that the promulgating authority enforces, to a person or a property based on a given set of facts.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Person” means:</text> <paragraph num="(a)"> <text>An individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind;</text> </paragraph> <paragraph num="(b)"> <text>A partnership, firm, association, corporation, or other entity; and</text> </paragraph> <paragraph num="(c)"> <text>A political subdivision of the State or an instrumentality of a political subdivision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Promulgating authority” means the promulgating authority's designee or an officer or unit of the Department that is authorized by law to adopt regulations subject to State Government Article, §§10-101—10-139, Annotated Code of Maryland, or adjudicate contested cases subject to State Government Article, §§10-201—10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Petition."> <paragraph num="A."> <text>An interested person may file with the promulgating authority a petition for a declaratory ruling.</text> </paragraph> <paragraph num="B."> <text>Petition for Declaratory Ruling. The petition for a declaratory ruling shall be filed in writing and shall describe in detail:</text> <paragraph num="(1)"> <text>The interest of the petitioner in making the request;</text> </paragraph> <paragraph num="(2)"> <text>The issues involved;</text> </paragraph> <paragraph num="(3)"> <text>A statement of the facts;</text> </paragraph> <paragraph num="(4)"> <text>A list of documents or statements the petitioner believes should be considered; and</text> </paragraph> <paragraph num="(5)"> <text>A sworn statement by the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Consideration and Disposition."> <paragraph num="A."> <text>Consideration and Disposition. The promulgating authority shall:</text> <paragraph num="(1)"> <text>Consider the petition and may issue the declaratory ruling requested;</text> </paragraph> <paragraph num="(2)"> <text>Notify the petitioner in writing of the action decided upon and state the reasons for the decision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Publication and Inspection.</text> <paragraph num="(1)"> <text>The promulgating authority shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to statutes or regulations involved.</text> </paragraph> <paragraph num="(2)"> <text>The promulgating authority may publish declaratory rulings of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Appeal."> <text>A declaratory ruling is subject to judicial review as provided in State Government Article, §10-305, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §§10-301—10-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 15, 1987 (14:12 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Chapter adopted as COMAR 10.01.13 recodified to COMAR 10.01.12</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 23, 1989 (16:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 11, 1994 (21:7 Md. R. 530)</annotation> </annotations> </chapter> <chapter num="13" heading="Procedures for Interagency Coordination for Licensing Residential Child Care Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>An applicant for a license for a residential child care facility or a residential child care program may seek a variance or waiver under this regulation. This chapter applies to licenses regulated by COMAR 10.22.03, 10.22.11, 10.22.14, 10.23.02, and 10.47.01 if the population of the facility is comprised of at least 90 percent children and if they are not regulated by the Health Resources Planning Commission through the Certificate of Need process.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Variance” means an alternative procedure to satisfy a specific licensing regulation.</text> </paragraph> <paragraph num="(3)"> <text>“Waiver” means the setting aside of a specific licensing regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Variance."> <paragraph num="A."> <text>An applicant for a license under the chapters listed in Regulation .01, of this chapter, may request a variance to specific licensing regulations.</text> </paragraph> <paragraph num="B."> <text>An application for a variance shall:</text> <paragraph num="(1)"> <text>Be written;</text> </paragraph> <paragraph num="(2)"> <text>Contain specific details of the alternative procedures proposed by the applicant; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate that the alternative procedures proposed shall:</text> <paragraph num="(a)"> <text>Meet or produce the intended effects of each regulation for which the variance is requested and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the health, safety, and well-being of children in the facility at or above the level required by each regulation for which the variance is requested.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Department Action on Application for Variance."> <paragraph num="A."> <text>Upon consideration of an application for variance, the Secretary may grant the request for a variance, if the:</text> <paragraph num="(1)"> <text>Applicant has submitted an application in accordance with the provisions of Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Applicant has complied with all other applicable licensing regulations of the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Secretary determines that the alternative procedure proposed by the applicant shall:</text> <paragraph num="(a)"> <text>Meet or produce the intended effect of the regulation, and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the health, safety, and well-being of children in the facility at or above the level required by the regulation at issue.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The determination of the Secretary upon the application for variance shall be in writing, and mailed to the applicant within 60 days of the date the application for variance is received by the Department.</text> </paragraph> <paragraph num="C."> <text>If granted, the variance may remain in effect for the term of the license and may be renewed upon application of the licensee when the license is renewed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application for Waiver."> <paragraph num="A."> <text>An applicant for a license under the COMAR chapters listed in Regulation .01, of this chapter, may request a waiver of specific provisions of licensing regulations.</text> </paragraph> <paragraph num="B."> <text>An application for a waiver shall:</text> <paragraph num="(1)"> <text>Be written;</text> </paragraph> <paragraph num="(2)"> <text>Contain specific facts upon which the waiver is requested; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate that:</text> <paragraph num="(a)"> <text>The waiver is necessary to meet the requirements of any federal child care licensing program; or</text> </paragraph> <paragraph num="(b)"> <text>Enforcement of the regulation for which a waiver is requested is contrary to the purposes of the statute under which the regulations are promulgated, and it would be unduly burdensome and inequitable for the applicant to comply with the provisions of the regulation for which a waiver is requested.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Department Action on Application for Waiver."> <paragraph num="A."> <text>The Secretary may grant a waiver of provisions of the applicable licensing regulation if the:</text> <paragraph num="(1)"> <text>Applicant has filed a written request for a waiver in accordance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Waiver is not inconsistent with the purposes and provisions of the statute under which the regulations are promulgated, and the health, safety, and well-being of the children in the facility will not be jeopardized solely by the granting of the waiver; and</text> </paragraph> <paragraph num="(3)"> <text>Applicant has demonstrated the facts required in Regulation .05B(3) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The determination of the Secretary upon the application for waiver shall be in writing, and mailed to the applicant within 60 days of the date the application for the waiver is received by the Department.</text> </paragraph> <paragraph num="C."> <text>If granted, the waiver may remain in effect for the term of the license and may be renewed upon application of the licensee when the license is renewed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Appeals."> <text>An applicant aggrieved by a determination of the Secretary upon an application for waiver or variance may file an appeal of the determination in accordance with the Administrative Procedure Act, State Government Article, §§10-201—10-405, Annotated Code of Maryland, and the Department's regulations governing administrative appeals taken pursuant to the Administrative Procedure Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7-714, 7-903, 8-403, 8-404, 10-204, 10-514—10-524, and 10-920—10-926, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 11, 1993 (20:20 Md. R. 1571)</annotation> </annotations> </chapter> <chapter num="14" heading="Open Meetings — Attendance and Recording, Photographing, and Broadcasting of Sessions"> <regulation prefix="Regulation" num=".01" heading="Definition."> <text>“Public body” means the entity defined at State Government Article, §10-502(h), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Public Attendance."> <paragraph num="A."> <text>The general public may attend and observe an open session of a public body within or established by the Maryland Department of Health.</text> </paragraph> <paragraph num="B."> <text>Except in instances when a public body expressly invites public testimony, questions, comments, or other forms of public participation, or when public participation is otherwise authorized by law, a member of the public attending an open session may not participate in the session.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disruptive Conduct."> <paragraph num="A."> <text>Prohibition. An individual attending an open session of a public body may not engage in any conduct, including a visual demonstration such as the waving of a placard, sign, or banner, that disrupts the session or that interferes with the right of a member of the public to attend and observe the session.</text> </paragraph> <paragraph num="B."> <text>Action to Restore Order. The presiding officer may:</text> <paragraph num="(1)"> <text>Order an individual who engages in conduct prohibited by §A of this regulation, or who violates any other regulation concerning the conduct of an open session, to be removed from the session;</text> </paragraph> <paragraph num="(2)"> <text>Request police assistance to restore order; and</text> </paragraph> <paragraph num="(3)"> <text>Recess the session while order is restored.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Recording, Photographing, Videotaping, Broadcasting, and Televising of Open Sessions."> <paragraph num="A."> <text>A member of the public, including a representative of the news media, may record an open session of a public body by means of a tape recorder or another recording device, if the:</text> <paragraph num="(1)"> <text>Device does not create an excessive noise that interferes with the participation in a session by a member of the public body or the observation of the session by a member of the public;</text> </paragraph> <paragraph num="(2)"> <text>Device does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Recording is done openly so that it is obvious to those in attendance that the session is being recorded.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A member of the public, including a representative of the news media, may photograph or videotape the proceedings of a public body at an open session by means of a camera if the camera:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light or excessive noise that interferes with the participation of a member of the public body in the session or the observation of the session by a member of the public;</text> </paragraph> <paragraph num="(2)"> <text>Does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Is used openly so that it is obvious to those in attendance that the session is being recorded.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A representative of the news media may broadcast or televise the proceedings of a public body at an open session if the equipment used:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light or excessive noise that interferes with the participation of a member of the public body in the session or the observation of the session by a member of the public;</text> </paragraph> <paragraph num="(2)"> <text>Does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Is used openly so that it is obvious to those in attendance that the session is being broadcast or televised.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The presiding officer may restrict the movement of an individual who is using a recording device, camera, or broadcasting or televising equipment if the restriction is necessary to maintain the orderly conduct of the session.</text> </paragraph> <paragraph num="E."> <text>A public body may require that an individual, who intends to record, photograph, videotape, broadcast, or televise an open session, register in advance of the beginning of the meeting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Recordings Not Part of the Record."> <text>A recording of an open session made by a member of the public, or a transcript derived from the recording, is not a part of the record of a proceeding of a public body.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §10-507(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 24, 1993 (20:10 Md. R. 851)</annotation> </annotations> </chapter> <chapter num="15" heading="Exemption from Self-Referral Laws"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs exemptions from the prohibition on self-referral made by the Secretary in conjunction with the Maryland Health Care Commission.</text> </paragraph> <paragraph num="B."> <text>This chapter creates the means by which the Secretary and the Maryland Health Care Commission can determine whether:</text> <paragraph num="(1)"> <text>A health care practitioner's beneficial interest is essential to finance and to provide a health care entity; and</text> </paragraph> <paragraph num="(2)"> <text>The health care entity is needed to ensure appropriate access for a community to the services provided by the health care entity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter interprets certain definitions and terms used in the statute for the purpose of enforcement by the licensing boards of the Maryland Department of Health.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions—Applicable to Health Occupations Article, §1-301 et seq., Annotated Code of Maryland."> <paragraph num="A."> <text>For the purpose of enforcing Health Occupations Article, §1-301 et seq., Annotated Code of Maryland, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Group practice” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Health Care Service.</text> <paragraph num="(a)"> <text>“Health care service” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Health care service” includes but is not limited to:</text> <paragraph num="(i)"> <text>Supplies;</text> </paragraph> <paragraph num="(ii)"> <text>Drugs; and</text> </paragraph> <paragraph num="(iii)"> <text>Items furnished to a patient by a health care entity..</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Members of the group” means health care practitioners:</text> <paragraph num="(a)"> <text>With an ownership interest in the group practice; or</text> </paragraph> <paragraph num="(b)"> <text>Who are full-time or part-time contractors or employees during the time they furnish services to patients of the group practice that are furnished through the group and are billed in the name of the group.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Patient care services” means the total patient care time spent on any task performed by a group practice member that addresses the medical needs of specific patients, regardless of whether they involve direct patient encounters, and including but not limited to time spent:</text> <paragraph num="(a)"> <text>By a member of the group in consultation with other health care practitioners, whether or not they are members of the group; and</text> </paragraph> <paragraph num="(b)"> <text>Reviewing laboratory tests, as well as the services of other health care practitioners who do not directly treat patients.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Personally supervised” means the responsibility of a health care practitioner to exercise on-site supervision or immediately available direction for employees performing referred in-office ancillary services or tests.</text> </paragraph> <paragraph num="(6)"> <text>“Referring health care practitioner” means a health care practitioner, or group practice, who makes a referral.</text> </paragraph> <paragraph num="(7)"> <text>“Rental or lease of office space” means payments made for the rental or lease of utilities, use of equipment, and secretarial and support staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions—For Exemption from Self-Referral Laws."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Area of concentration” means a limitation of practice by demonstrable training and competence of a health care practitioner.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Essential” means a health care entity would not be able to exist but for the health care practitioner's beneficial interest in the health care entity.</text> </paragraph> <paragraph num="(4)"> <text>“Health care entity” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>Health Care Practitioner.</text> <paragraph num="(a)"> <text>“Health care practitioner has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Health care practitioner” does not include a mortician, an assisted living manager, or a nursing home administrator, unless the mortician, assisted living manager, or nursing home administrator is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services by any board other than the Board of Morticians and Funeral Directors or the Board of Long-Term Care Administrators.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Maryland Health Care Commission (MHCC)” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(7)"> <text>“Referral” has the meaning stated in Health Occupation Article, §1-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Requestor” means an individual other than the health care practitioner who is an attorney admitted to the Maryland Bar or specially admitted to practice law in the State under Maryland Rules Title 19.</text> </paragraph> <paragraph num="(9)"> <text>“Secretary” means the Secretary of the Maryland Department of Health or their designee.</text> </paragraph> <paragraph num="(10)"> <text>“Specialty” means “area of concentration” as defined in §B(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Exemption."> <text>The Secretary may exempt a health care practitioner from the prohibition on self-referral pursuant to Health Occupations Article, §1-302(d)(5), Annotated Code of Maryland, in accordance with this chapter.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Request for Exemption."> <paragraph num="A."> <text>A health care practitioner who has or wishes to have a beneficial interest in a health care entity may request from the Secretary an exemption from the self-referral laws.</text> </paragraph> <paragraph num="B."> <text>In order for a health care practitioner to obtain an exemption by the Secretary from the self-referral laws, the health care practitioner shall make a request to the Secretary in the manner specified by the Department that:</text> <paragraph num="(1)"> <text>Identifies the street address, political subdivision, and area of concentration of both the health care practitioner and the entity in which the practitioner has or wishes to have a beneficial interest;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates to the Secretary's satisfaction that the health care practitioner's beneficial interest is:</text> <paragraph num="(a)"> <text>Essential to finance and to provide the health care entity; and</text> </paragraph> <paragraph num="(b)"> <text>Needed to ensure appropriate access for the community to the services provided at the health care entity;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>States when the services are proposed to begin;</text> </paragraph> <paragraph num="(4)"> <text>Provides the health care practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Licensing board;</text> </paragraph> <paragraph num="(c)"> <text>License number;</text> </paragraph> <paragraph num="(d)"> <text>License expiration date;</text> </paragraph> <paragraph num="(e)"> <text>Business address; and</text> </paragraph> <paragraph num="(f)"> <text>Business telephone number;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Includes an attestation in writing that, if the health care practitioner seeks renewal of an exemption from the Secretary and the Secretary no longer deems the beneficial interest to be essential, the practitioner shall:</text> <paragraph num="(a)"> <text>Immediately cease accepting any referrals from sources prohibited under Health Occupations Article, §1-301 et seq., Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Divest the practitioner's beneficial interest in the entity within 1 year after the exemption is no longer applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Request to MHCC.</text> <paragraph num="(1)"> <text>The Secretary shall request, in writing, the advice of the Executive Director of the MHCC concerning whether the beneficial interest is needed to ensure appropriate access for the community to the services provided at the health care entity.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary shall provide, with the request to the Executive Director of the MHCC, a copy of any materials submitted to the Department in accordance with §B of this regulation and any additional items which may be pertinent to the MHCC’s review.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary shall follow the timetable set forth in Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Executive Director of the MHCC shall advise the Secretary in accordance with the timetable in Regulation .06 of this chapter as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity.</text> </paragraph> <paragraph num="E."> <text>If additional information is needed by the Secretary or the Executive Director of MHCC for their determination, the Department may ask the health care practitioner to provide additional information to establish that the practitioner’s beneficial interest is:</text> <paragraph num="(1)"> <text>Essential to finance and to provide the health care entity; and</text> </paragraph> <paragraph num="(2)"> <text>Needed to ensure appropriate access for the community to the services provided at the health care entity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Timetable for the Secretary's Action."> <paragraph num="A."> <text>The Secretary shall make the required determinations within 90 calendar days following receipt of a health care practitioner's request for exemption.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall request advice from the Executive Director of the MHCC as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 30 calendar days of receipt of the health care practitioner’s request for exemption.</text> </paragraph> <paragraph num="C."> <text>The Executive Director of the MHCC shall advise the Secretary as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 60 calendar days after receipt of the Secretary's letter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal of Exemption."> <paragraph num="A."> <text>The term of an exemption shall be in conjunction with a health care practitioner's professional license renewal and shall be renewed at the same time the health care practitioner's professional license is renewed.</text> </paragraph> <paragraph num="B."> <text>The exemption expires at the end of its term, unless the exemption is renewed in accordance with this regulation.</text> </paragraph> <paragraph num="C."> <text>An exempted health care practitioner, on renewal, shall meet all the requirements of this chapter at the time of renewal.</text> </paragraph> <paragraph num="D."> <text>Each health care practitioner who has been exempted by the Secretary from the prohibition on self-referral as an essential health care entity needed for access to health care shall renew the health care practitioner's exemption status in the manner provided by the Department at the time of licensure, certification, or other form of practice renewal authorized under the Health Occupations Article, Annotated Code of Maryland, within the time period specified on the form.</text> </paragraph> <paragraph num="E."> <text>At a minimum, the health care practitioner shall provide, at the time of renewal, to the Department:</text> <paragraph num="(1)"> <text>A copy of the initial exemption request;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the Secretary’s approval of the initial exemption;</text> </paragraph> <paragraph num="(3)"> <text>The items specified in Regulation .05B of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Any additional pertinent information as requested by the Secretary.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Each exempted health care practitioner shall keep the appropriate licensing, certification, or other practice authorizing board apprised of the health care practitioner’s current business address.</text> </paragraph> <paragraph num="G."> <text>On request by the Department, the relevant board or boards shall supply the current business addresses of exempted health care practitioners.</text> </paragraph> <paragraph num="H."> <text>The Department shall mail a notice of the required renewal to the health care practitioner at the current business address supplied by the appropriate board.</text> </paragraph> <paragraph num="I."> <text>If an exempted health care practitioner does not receive notice of renewal, it is the exempted health care practitioner's responsibility to notify the Department so that the Secretary may renew the exemption before the expiration of the current exemption.</text> </paragraph> <paragraph num="J."> <text>Failure to Renew Exemption.</text> <paragraph num="(1)"> <text>If an exempted health care practitioner fails to renew the exemption, the practitioner is not considered exempted under the Health Occupations Article, §1-301(d)(5), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>If an exempted health care practitioner fails to renew the exemption, and fails to carry out the agreed requirements set forth in Regulation .05B(6) of this chapter, the practitioner shall be subject to disciplinary action as set forth in Health Occupations Article, §1-307, Annotated Code of Maryland, for violation of the self-referral laws.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b); Health Occupations Article, §1-301 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 25, 2001 (28:12 Md. R. 1106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 30, 2026 (53:6 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 30, 2026 (53:6 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 30, 2026 (53:6 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 30, 2026 (53:6 Md. R. 290)</annotation> </annotations> </chapter> <chapter num="16" heading="Retention and Disposal of Medical Records and Protected Health Information"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to medical records and protected health information held by health care providers practicing in Maryland, their agents, and their records management service.</text> </paragraph> <paragraph num="B."> <text>This chapter does not supersede any federal or State laws or regulations that exceed this chapter's requirements by requiring that a medical record:</text> <paragraph num="(1)"> <text>Be retained for a longer period of time;</text> </paragraph> <paragraph num="(2)"> <text>Be afforded greater security measures;</text> </paragraph> <paragraph num="(3)"> <text>Be afforded more privacy measures; and</text> </paragraph> <paragraph num="(4)"> <text>Be more easily accessible to the patient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter is not intended to address the disposition of abandoned medical records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Divisible” means a medical record that is amenable to separation or division after the expiration of the retention time stated in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Health Care Provider.</text> <paragraph num="(a)"> <text>“Health care provider” means an acupuncturist, audiologist, chiropractor, dietician, dentist, electrologist, massage therapist, mortician, nurse, nutritionist, occupational therapist, optometrist, physical therapist, physician, podiatrist, professional counselor, psychologist, social worker, speech-language pathologist, or a health care facility or entity that is a:</text> <paragraph num="(i)"> <text>Freestanding, ambulatory care facility as defined in Health-General Article, §19-3B-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>Hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>Limited service hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>Related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vii)"> <text>Residential treatment center as defined in Health-General Article, §19-301, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(viii)"> <text>Health care facility as defined in Health-General Article, §10-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care provider” includes an agent, officer, director, or employee of any entity listed in §B(2)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medical Record.</text> <paragraph num="(a)"> <text>“Medical record” means any oral, written, or other transmission in any form or medium of information that:</text> <paragraph num="(i)"> <text>Is entered in the record of a patient;</text> </paragraph> <paragraph num="(ii)"> <text>Identifies or can readily be associated with the identity of a patient; and</text> </paragraph> <paragraph num="(iii)"> <text>Relates to the health care of the patient.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Medical record” includes any:</text> <paragraph num="(i)"> <text>Documentation of disclosures of the medical record to any person who is not an employee, agent, or consultant of the health care provider;</text> </paragraph> <paragraph num="(ii)"> <text>File or record maintained under Health Occupations Article, §12-403(b)(13), Annotated Code of Maryland, by a pharmacy of a prescription order for drugs, medicines, or devices that identifies or may be readily associated with the identity of a patient;</text> </paragraph> <paragraph num="(iii)"> <text>Documentation of an examination of a patient regardless of who requested the examination or is making payment for the examination;</text> </paragraph> <paragraph num="(iv)"> <text>File or record received from another health care provider that relates to the health care of a patient received from that health care provider, and identifies or can readily be associated with the identity of the patient; and</text> </paragraph> <paragraph num="(v)"> <text>To the extent not narrowed by §B(3)(a) and (b)(i)—(iv) of this regulation, “protected health information” as defined by 45 CFR §160.103, as amended.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Medical records series” means a set of medical records, as defined in §B(3) of this regulation, that is maintained on paper, microform, magnetic disk, magnetic tape, or other medium.</text> </paragraph> <paragraph num="(5)"> <text>“Patient” has the meaning stated in Health-General Article, §4-301(j), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Person in interest” has the meaning stated in Health-General Article, §4-301(k), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Records management service” means any agent that has been procured by a health care provider to transport, handle, manage, maintain, store, or destroy medical records.</text> </paragraph> <paragraph num="(8)"> <text>“Records retention schedule” means a records management plan that includes:</text> <paragraph num="(a)"> <text>A list and description of the medical records series of an office or unit;</text> </paragraph> <paragraph num="(b)"> <text>The minimum retention period required to keep each medical record series;</text> </paragraph> <paragraph num="(c)"> <text>The eventual disposition instructions;</text> </paragraph> <paragraph num="(d)"> <text>If desired:</text> <paragraph num="(i)"> <text>Maintenance procedures, such as access or copy control, for each medical records series both in office and in storage;</text> </paragraph> <paragraph num="(ii)"> <text>Scanning or microfilming instructions; or</text> </paragraph> <paragraph num="(iii)"> <text>Disposal methods such as shredding or incineration; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A signature of approval by an individual with authority over all the medical records series listed.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Sanitizing” means overwriting, degaussing, shredding, or burning electronic or other media.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>45 CFR Part 160, as amended; and</text> </paragraph> <paragraph num="B."> <text>45 CFR Part 164, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Maintenance of Medical Records."> <paragraph num="A."> <text>A health care provider shall develop and maintain a records retention schedule compatible with the requirements of Regulations .04—.07 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Except as provided in Regulations .06 and .07 of this chapter, a health care provider shall maintain medical records for all patients in the health care provider's care for a minimum of 5 years after the medical record is made or until the patient is 21 years old, whichever is longer.</text> </paragraph> <paragraph num="C."> <text>Medical records are the personal property of the entity providing health care and are maintained for:</text> <paragraph num="(1)"> <text>The patient;</text> </paragraph> <paragraph num="(2)"> <text>The medical or treatment staff; and</text> </paragraph> <paragraph num="(3)"> <text>Other treatment, payment, and health care operations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A health care provider shall retain medical records in:</text> <paragraph num="(1)"> <text>An office with access restricted to authorized staff;</text> </paragraph> <paragraph num="(2)"> <text>A computer or other device with appropriate security such as passwords or data encryption;</text> </paragraph> <paragraph num="(3)"> <text>A commercial records storage site with appropriate environmental and security controls; or</text> </paragraph> <paragraph num="(4)"> <text>Other storage options that ensure protection, security, and access control.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Maintenance of medical records may be contracted to a records management service that agrees to comply with and be subject to this chapter.</text> </paragraph> <paragraph num="F."> <text>Medical records that have been placed in storage remain the responsibility of the health care provider, including:</text> <paragraph num="(1)"> <text>Providing the patient or person in interest access to their medical records and authorized copies upon request in accordance with Health-General Article, §4-304, Annotated Code of Maryland, and 45 CFR §164.524, as amended;</text> </paragraph> <paragraph num="(2)"> <text>Ensuring the confidentiality of the medical records;</text> </paragraph> <paragraph num="(3)"> <text>Providing security and restricted access to the medical records; and</text> </paragraph> <paragraph num="(4)"> <text>Protecting the medical records from:</text> <paragraph num="(a)"> <text>Damage;</text> </paragraph> <paragraph num="(b)"> <text>Loss; and</text> </paragraph> <paragraph num="(c)"> <text>Deterioration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If a medical record is kept in electronic form, a health care provider shall:</text> <paragraph num="(1)"> <text>Maintain or have access to compatible electronic hardware and software that will enable the health care provider to generate a legible copy of the record in order to comply with patient and governmental access needs; and</text> </paragraph> <paragraph num="(2)"> <text>Prepare and maintain a current back-up copy of electronic medical record files.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disposal of Medical Records."> <paragraph num="A."> <text>A health care provider shall maintain a medical record in accordance with the records retention schedule and may dispose of the record when the minimum retention requirements as described in Regulation .04B of this chapter have been met.</text> </paragraph> <paragraph num="B."> <text>For purposes of destruction, a medical record is an indivisible entity unless, in the health care provider's professional judgment, the medical record is divisible.</text> </paragraph> <paragraph num="C."> <text>A health care provider shall ensure confidentiality of medical records throughout the disposal process:</text> <paragraph num="(1)"> <text>For paper records, by incineration, shredding, pulping, or other comparable process which renders the records permanently unreadable;</text> </paragraph> <paragraph num="(2)"> <text>For electronic or magnetic media, such as computer disks or magnetic tapes, by completely sanitizing the media, and not just by erasure or deletion;</text> </paragraph> <paragraph num="(3)"> <text>For other media, such as film, photos, or compact discs, by destroying the media with no possibility of recovery; and</text> </paragraph> <paragraph num="(4)"> <text>By complying with the HIPAA security provisions at 45 CFR §164.310(d), as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Instructions for Handling Medical Records Upon Discontinuation of Medical Practice."> <paragraph num="A."> <text>At the time a health care provider discontinues medical practice, the health care provider shall immediately secure the medical records until one of the following options are taken:</text> <paragraph num="(1)"> <text>Medical records may be transferred to a health care provider who will be assuming the medical practice;</text> </paragraph> <paragraph num="(2)"> <text>Medical records may be given to the patient;</text> </paragraph> <paragraph num="(3)"> <text>At the patient's direction, the medical record may be transferred to a new health care provider; or</text> </paragraph> <paragraph num="(4)"> <text>Medical records may be destroyed in accordance with §B of this regulation, Regulation .07 of this chapter, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On the death, retirement, surrender of license, or discontinuance of the practice or business of a health care provider, the administrator of the estate or a designee, who:</text> <paragraph num="(1)"> <text>Agrees to provide for the maintenance of the medical records of the practice; and</text> </paragraph> <paragraph num="(2)"> <text>States in writing to the appropriate health occupations board within a reasonable time that the medical records will be maintained in compliance with this chapter, shall:</text> <paragraph num="(a)"> <text>Publish a notice in a daily newspaper that is circulated locally for 2 consecutive weeks:</text> <paragraph num="(i)"> <text>Stating that the medical records will be destroyed or transferred; and</text> </paragraph> <paragraph num="(ii)"> <text>Designating a location, date, and time when the medical records may be retrieved by the person in interest; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Forward the notice required in §B(2)(a), of this regulation, to the patient in the following manner:</text> <paragraph num="(i)"> <text>In the case of an adult, the notification shall be sent by first-class mail to the last known address of the patient; or</text> </paragraph> <paragraph num="(ii)"> <text>In the case of a minor, notification shall be sent by first-class mail to the last known address of the parent or guardian, or if the medical care documented was provided under Health-General Article, §20-102(c) or 20-103(c), Annotated Code of Maryland, notification shall be given to the minor, by certified mail, addressee only.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prerequisites for Early Destruction of Medical Records."> <text>Medical records that have not met the retention requirements of Regulation .04 of this chapter, may be destroyed only if:</text> <paragraph num="A."> <text>In the case of an adult, notification is sent by first-class mail to the last known address of the patient which includes:</text> <paragraph num="(1)"> <text>The proposed date of disposal; and</text> </paragraph> <paragraph num="(2)"> <text>A statement that the record, or a synopsis of the record, may be retrieved at a designated location within 30 days of the proposed destruction; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the case of a minor, notification is sent by first-class mail to the last known address of the parent or guardian, or if the medical care documented was provided under Health-General Article, §20-102(c) or 20-103(c), Annotated Code of Maryland, notification is given to the minor, by certified mail, addressee only, which includes:</text> <paragraph num="(1)"> <text>The proposed date of disposal; and</text> </paragraph> <paragraph num="(2)"> <text>A statement that the record, or a synopsis of the record, may be retrieved at a designated location within 30 days of the proposed destruction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Enforcement."> <paragraph num="A."> <text>For entities and individuals not regulated by the Office of Health Care Quality or the appropriate health occupations board, the Secretary shall have the authority to investigate any complaint concerning medical records that are covered by this chapter. By letter, the Secretary may delegate this authority to any unit of the Department, including a health occupations board, the Office of Health Care Quality, or the Office of the Inspector General.</text> </paragraph> <paragraph num="B."> <text>To ensure compliance and enforce this chapter:</text> <paragraph num="(1)"> <text>The Office of Health Care Quality shall have authority over a health care facility; and</text> </paragraph> <paragraph num="(2)"> <text>A health occupations board shall have authority over an individual who is a health care provider.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Office of Health Care Quality, the appropriate health occupations board, or both, shall investigate any complaint concerning medical records that are or were in the possession of a person or entity covered by this chapter.</text> </paragraph> <paragraph num="D."> <text>After giving a person or entity an opportunity for a hearing to be held in accordance with the disciplinary hearing procedures that would be applicable to a health care provider who owned or possessed the medical records at issue, the Office of Health Care Quality, the appropriate health occupations board, or both, may impose any fines stated in Regulation .09B, of this chapter, as appropriate.</text> </paragraph> <paragraph num="E."> <text>After giving a person or entity an opportunity for a hearing to be held in accordance with COMAR 10.01.03, the Secretary may impose any fines stated in Regulation .09B of this chapter for entities which are not regulated by the Office of Health Care Quality or an appropriate health occupations board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Penalties."> <paragraph num="A."> <text>Damages. As provided in Health-General Article, §4-403(g)(1), Annotated Code of Maryland, a health care provider, record management service, or other person who knowingly violates any provision of Health-General Article, Title 4, Subtitle 4, is liable in court for actual damages.</text> </paragraph> <paragraph num="B."> <text>Fines.</text> <paragraph num="(1)"> <text>A health care facility that knowingly violates this chapter is subject to an administrative fine not to exceed $10,000 for all violations cited in a single day.</text> </paragraph> <paragraph num="(2)"> <text>In addition to any other penalties provided, an individual who is a health care provider, an agent, employee, officer, or director of a health care provider, or a records management service, who knowingly violates this chapter, is subject to administrative fines as follows:</text> <paragraph num="(a)"> <text>The first fine or set of fines assessed in a single day may not exceed $1,000;</text> </paragraph> <paragraph num="(b)"> <text>The second fine or second set of fines assessed concurrently for all violations cited in a single day may not exceed $2,500; and</text> </paragraph> <paragraph num="(c)"> <text>The third or subsequent fine assessed, or third or subsequent set of fines assessed concurrently, for all violations cited in a single day may not exceed $5,000.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Factors to be Considered in the Assessment of Penalties. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary, the Office of Health Care Quality, or the appropriate health occupations board shall consider the following factors:</text> <paragraph num="(1)"> <text>The nature and seriousness of the violations;</text> </paragraph> <paragraph num="(2)"> <text>The willfulness of the violation or violations;</text> </paragraph> <paragraph num="(3)"> <text>The history of previous violations;</text> </paragraph> <paragraph num="(4)"> <text>The extent of the actual harm or potential risk of divulging confidential information;</text> </paragraph> <paragraph num="(5)"> <text>The efforts made to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(6)"> <text>The existence of mitigating factors.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403, Annotated Code of Maryland;</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 2008 (35:6 Md. R. 697)</annotation> </annotations> </chapter> <chapter num="17" heading="Fees for Food Protection, Public Pools, Public Spas, Public Spray Grounds, and Youth Camp Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to entities regulated by the Office of Food Protection and the Office of Healthy Homes and Communities.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Secretary:</text> <paragraph num="A."> <text>Annual permit or inspection fee for:</text> <paragraph num="(1)"> <text>Bobtailer — $50;</text> </paragraph> <paragraph num="(2)"> <text>Bulk milk hauler/sampler — $50;</text> </paragraph> <paragraph num="(3)"> <text>Certified industry dairy farm inspector — $10;</text> </paragraph> <paragraph num="(4)"> <text>Distribution station — $25;</text> </paragraph> <paragraph num="(5)"> <text>Farmstead cheese processor — $100;</text> </paragraph> <paragraph num="(6)"> <text>Milk processor — $100;</text> </paragraph> <paragraph num="(7)"> <text>Milk tank truck cleaning facility — $25;</text> </paragraph> <paragraph num="(8)"> <text>Milk transportation company — $5, plus $5 for each milk tank truck;</text> </paragraph> <paragraph num="(9)"> <text>Receiving station — $25; and</text> </paragraph> <paragraph num="(10)"> <text>Transfer station — $25;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Annual youth camp application fee based on estimated camper days, that is, the estimated average number of campers enrolled each day multiplied by the estimated number of days a camp intends to operate during a camp season, for:</text> <paragraph num="(1)"> <text>Except as specified in §B(2) of this regulation:</text> <paragraph num="(a)"> <text>On or before December 31, 2016, day camp:</text> <paragraph num="(i)"> <text>1 to 500 camper days — $200;</text> </paragraph> <paragraph num="(ii)"> <text>501 to 2,000 camper days — $525;</text> </paragraph> <paragraph num="(iii)"> <text>2,001 to 5,000 camper days — $700; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 5,000 camper days — $900;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective January 1, 2017, day camp:</text> <paragraph num="(i)"> <text>1 to 500 camper days — $190;</text> </paragraph> <paragraph num="(ii)"> <text>501 to 2,000 camper days — $500;</text> </paragraph> <paragraph num="(iii)"> <text>2,001 to 5,000 camper days — $665; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 5,000 camper days — $855; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Residential camp:</text> <paragraph num="(i)"> <text>1 to 700 camper days — $500;</text> </paragraph> <paragraph num="(ii)"> <text>701 to 5,000 camper days — $1,000;</text> </paragraph> <paragraph num="(iii)"> <text>5,001 to 16,000 camper days — $1,500; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 16,000 camper days — $2,000; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a youth camp that is in good standing as defined in COMAR 10.16.06.02:</text> <paragraph num="(a)"> <text>On or before December 31, 2016, day camp:</text> <paragraph num="(i)"> <text>1 to 500 camper days — $50;</text> </paragraph> <paragraph num="(ii)"> <text>501 to 2,000 camper days — $130;</text> </paragraph> <paragraph num="(iii)"> <text>2,001 to 5,000 camper days — $175; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 5,000 camper days — $225;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective January 1, 2017, day camp:</text> <paragraph num="(i)"> <text>1 to 500 camper days — $45;</text> </paragraph> <paragraph num="(ii)"> <text>501 to 2,000 camper days — $125;</text> </paragraph> <paragraph num="(iii)"> <text>2,001 to 5,000 camper days — $165; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 5,000 camper days — $215; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Residential camp:</text> <paragraph num="(i)"> <text>1 to 700 camper days — $125;</text> </paragraph> <paragraph num="(ii)"> <text>701 to 5,000 camper days — $250;</text> </paragraph> <paragraph num="(iii)"> <text>5,001 to 16,000 camper days — $375; and</text> </paragraph> <paragraph num="(iv)"> <text>Greater than 16,000 camper days — $500.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Annual license fee for:</text> <paragraph num="(1)"> <text>Food processing plants:</text> <paragraph num="(a)"> <text>Bakery plant — $150;</text> </paragraph> <paragraph num="(b)"> <text>Cannery — $150;</text> </paragraph> <paragraph num="(c)"> <text>Charity deer processing plant, as defined in COMAR 10.15.04 — no fee;</text> </paragraph> <paragraph num="(d)"> <text>Civic or nonprofit organizations that process meat for human consumption no more than three times a year for 5 days or less each time — $150;</text> </paragraph> <paragraph num="(e)"> <text>Confectionary plant — $150;</text> </paragraph> <paragraph num="(f)"> <text>Crab meat plant — $150;</text> </paragraph> <paragraph num="(g)"> <text>Ice manufacturing plant — $150;</text> </paragraph> <paragraph num="(h)"> <text>Shellfish:</text> <paragraph num="(i)"> <text>Shucking, packing, or repacking plant — $150;</text> </paragraph> <paragraph num="(ii)"> <text>Shipping or reshipping plant — $150; or</text> </paragraph> <paragraph num="(iii)"> <text>Seasonal shellstock shipping or reshipping plant — $100;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Food manufacturing plant — $150;</text> </paragraph> <paragraph num="(j)"> <text>A food warehouse or distribution center that distributes:</text> <paragraph num="(i)"> <text>Potentially hazardous food — $150; or</text> </paragraph> <paragraph num="(ii)"> <text>Only non-potentially hazardous food — $150;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Bottled water plant — $150;</text> </paragraph> <paragraph num="(l)"> <text>Soft drink manufacturing plant — $150;</text> </paragraph> <paragraph num="(m)"> <text>Frozen food manufacturing plant — $150;</text> </paragraph> <paragraph num="(n)"> <text>Seasonal food manufacturing plant — $35;</text> </paragraph> <paragraph num="(o)"> <text>On-farm home processing plant — $30; and</text> </paragraph> <paragraph num="(p)"> <text>Producer mobile farmer’s market unit — $100; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Frozen dessert mix or frozen dessert plant with manufacturing capacity of:</text> <paragraph num="(a)"> <text>0 to 25,000 gallons — $10;</text> </paragraph> <paragraph num="(b)"> <text>25,001 to 100,000 gallons — $50;</text> </paragraph> <paragraph num="(c)"> <text>100,001 to 250,000 gallons — $100;</text> </paragraph> <paragraph num="(d)"> <text>250,001 to 500,000 gallons — $150; and</text> </paragraph> <paragraph num="(e)"> <text>Over 500,000 gallons — $200;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Except for a local subdivision with delegated authority, plan review fee for food processing plants:</text> <paragraph num="(1)"> <text>Bakery plant — $300;</text> </paragraph> <paragraph num="(2)"> <text>Bottled water plant — $300;</text> </paragraph> <paragraph num="(3)"> <text>Cannery — $300;</text> </paragraph> <paragraph num="(4)"> <text>Charity deer processing plant — no fee;</text> </paragraph> <paragraph num="(5)"> <text>Civic or nonprofit organizations that process meat for human consumption no more than three times a year for 5 days or less each time — $150;</text> </paragraph> <paragraph num="(6)"> <text>Confectionary plant — $300;</text> </paragraph> <paragraph num="(7)"> <text>Crab meat plant — $300;</text> </paragraph> <paragraph num="(8)"> <text>Food manufacturing plant — $300;</text> </paragraph> <paragraph num="(9)"> <text>Food manufacturing plant operating in another licensed food establishment — $200;</text> </paragraph> <paragraph num="(10)"> <text>Food warehouse or distribution center — $300;</text> </paragraph> <paragraph num="(11)"> <text>Frozen food manufacturing plant — $300;</text> </paragraph> <paragraph num="(12)"> <text>Ice manufacturing plant — $300;</text> </paragraph> <paragraph num="(13)"> <text>On-farm home processing plant — no fee;</text> </paragraph> <paragraph num="(14)"> <text>Producer mobile farmer’s market unit — no fee;</text> </paragraph> <paragraph num="(15)"> <text>Seasonal food manufacturing plant — no fee; and</text> </paragraph> <paragraph num="(16)"> <text>Shellfish:</text> <paragraph num="(a)"> <text>Shucking, packing, or repacking plant — $300;</text> </paragraph> <paragraph num="(b)"> <text>Shipping or reshipping plant — no fee; or</text> </paragraph> <paragraph num="(c)"> <text>Seasonal shellstock shipping or reshipping plant — no fee;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Plan review fee for a food service facility that is a retail chain or a franchise operation planning to construct two or more facilities in the State from a single uniform set of plans — $300;</text> </paragraph> <paragraph num="F."> <text>Food process or hazard analysis critical control point plan review:</text> <paragraph num="(1)"> <text>In a retail facility or a food processing plant — $200; or</text> </paragraph> <paragraph num="(2)"> <text>In a bona fide civic or nonprofit organization that processes meat for human consumption no more than three times a year for 5 days or less each time — $150; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Except for a local subdivision with delegated authority, application review fee for:</text> <paragraph num="(1)"> <text>Construction of a public pool or spa — $300;</text> </paragraph> <paragraph num="(2)"> <text>Alterations at a public pool or spa — $200; and</text> </paragraph> <paragraph num="(3)"> <text>Replacements at a public pool or spa — $50.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Criminal History Record Checks. Fees for criminal history record checks for youth camp personnel in accordance with COMAR 10.16.06.21 shall be:</text> <paragraph num="(1)"> <text>$20 per background criminal history record check processed for a camp; and</text> </paragraph> <paragraph num="(2)"> <text>Paid by a youth camp licensee annually.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 14-403, 14-403.1, 14-407(B)(4), 21-301, 21-308, 21-309, 21-309.1, 21-403, 21-412, 21-808, and21-812, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 adopted as an emergency provision effective November 1, 2004 (31:23 Md. R. 1649); adopted permanently effective February 14, 2005 (32:3 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 13, 2015 (42:7 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 13, 2015 (42:7 Md. R. 567); August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective April 5, 2011 (38:10 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 25, 2006 (33:19 Md. R. 1560)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective September 17, 2012 (39:18 Md. R. 1196); December 21, 2015 (42:25 Md. R. 1542)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E, F adopted effective September 17, 2012 (39:18 Md. R. 1196)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H adopted as an emergency provision effective January 6, 2025 (52:2 Md. R. 65); amended permanently effective April 14, 2025 (52:7 Md. R. 321)</annotation> </annotations> </chapter> <chapter num="18" heading="Sexual Abuse Awareness and Prevention Training"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Prohibits inappropriate sexual behavior in covered programs; and</text> </paragraph> <paragraph num="B."> <text>Adopts awareness and prevention training and reporting requirements regarding inappropriate sexual behavior that a covered program shall fulfill in order to be licensed by the Department or any of its Administrations, or approved by the Department or any of its Administrations to receive funding to provide services in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Admission” means the process by which an individual is accepted as a resident or patient in a State facility and includes the physical act of the individual entering the State facility.</text> </paragraph> <paragraph num="(2)"> <text>“Central coordinator” means an individual or individuals designated by the Deputy Secretary for the unit of the Department responsible for the operations of each State facility to:</text> <paragraph num="(a)"> <text>Oversee development of policies and materials;</text> </paragraph> <paragraph num="(b)"> <text>Monitor compliance; and</text> </paragraph> <paragraph num="(c)"> <text>Identify and make recommendations for improving a State facility’s prevention and detection of, and response to, inappropriate sexual behavior in State facilities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Covered program” means any of the following facilities and programs:</text> <paragraph num="(a)"> <text>A State facility as defined in §B(22) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Non-State operated residential treatment centers for emotionally disturbed children and adolescents, licensed under COMAR 10.07.04;</text> </paragraph> <paragraph num="(c)"> <text>Vocational and day services programs, licensed by the Developmental Disabilities Administration under COMAR 10.22.02 and 10.22.07; and</text> </paragraph> <paragraph num="(d)"> <text>The following programs licensed by the Behavioral Health Administration:</text> <paragraph num="(i)"> <text>Psychiatric rehabilitation programs for adults licensed under COMAR 10.63.03.09;</text> </paragraph> <paragraph num="(ii)"> <text>Residential rehabilitation programs licensed under COMAR 10.63.04.05;</text> </paragraph> <paragraph num="(iii)"> <text>Supported employment programs licensed under COMAR 10.63.03.16; and</text> </paragraph> <paragraph num="(iv)"> <text>Psychiatric rehabilitation programs for minors licensed under COMAR 10.63.03.10.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>External Law Enforcement Agency.</text> <paragraph num="(a)"> <text>“External law enforcement agency” means the Department of State Police or a police agency of a county or municipal corporation.</text> </paragraph> <paragraph num="(b)"> <text>“External law enforcement agency” does not include the police force of the Maryland Department of Health.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Inappropriate sexual behavior” means:</text> <paragraph num="(a)"> <text>Sexual abuse as defined in §B(17) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Any sexual act, as defined in §B(18) of this regulation, between a staff member of a covered program and an individual receiving services at the covered program.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Individual” means a person receiving services or treatment at a State facility.</text> </paragraph> <paragraph num="(8)"> <text>“Initial plan of care” means the first plan of care created for an individual by the treatment team and is created at the first treatment team meeting.</text> </paragraph> <paragraph num="(9)"> <text>“Internal complaint process” means a written policy and procedure for a covered program’s handling and investigation of reports of inappropriate sexual behavior, as defined in §B(3) of this regulation, and appropriate actions in response to verified incidents of inappropriate sexual behavior, occurring within the covered program.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed” means being licensed by the Department or approved by the Department to receive funding to provide services in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Peer training” means awareness and prevention training regarding inappropriate sexual behavior that is provided by a peer of the individual receiving services.</text> </paragraph> <paragraph num="(12)"> <text>“Plan of care” means a written document addressing the needs of the individual receiving services from a covered program, and the covered program’s plan for provision of services and treatment to meet those needs, developed in accordance with applicable State and federal laws and regulations.</text> </paragraph> <paragraph num="(13)"> <text>“Program director” means the individual who is responsible for the daily operations of a covered program as outlined in the chapter under the appropriate subtitle that delineates the requirements for a specific program.</text> </paragraph> <paragraph num="(14)"> <text>“Protection plan” means a document created to address the individual’s needs, with respect to the individual’s:</text> <paragraph num="(a)"> <text>Risk of being subjected to the perpetrator of inappropriate sexual behavior at the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Treatment team’s plan for mitigating the individual’s risk.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Reasonable Safety Precautions.</text> <paragraph num="(a)"> <text>“Reasonable safety precautions” means an established set of measures, procedures, and protocols taken in order to maintain the safety of individuals upon admission to the State facility.</text> </paragraph> <paragraph num="(b)"> <text>Reasonable safety precautions may include but are not limited to:</text> <paragraph num="(i)"> <text>Unit restriction, including dining on the unit;</text> </paragraph> <paragraph num="(ii)"> <text>Increased nursing contacts or more frequent observation by nurses;</text> </paragraph> <paragraph num="(iii)"> <text>Restrictions on activities;</text> </paragraph> <paragraph num="(iv)"> <text>Increased staffing assigned to the individual; and</text> </paragraph> <paragraph num="(v)"> <text>Similar or additional measures implemented.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The type of reasonable safety precautions implemented and the reason for the reasonable safety precautions shall be documented in the individual’s records.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Risk assessment screen” means a uniform tool, developed by the Department, used by a facility to:</text> <paragraph num="(a)"> <text>Screen an individual for a history of being subjected to, or perpetrating, inappropriate sexual behavior, and related trauma; and</text> </paragraph> <paragraph num="(b)"> <text>Assess an individual’s risk of being subjected to, or perpetrating, inappropriate sexual behavior while at the facility.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Sexual Abuse.</text> <paragraph num="(a)"> <text>“Sexual abuse” means any sexual act, as defined in §B(18) of this regulation, that is made or threatened to be made without the consent of an individual who is the recipient of the action, or without the consent of an individual solicited to take the action, which occurs on the premises of a covered program or at any off-premises activity sponsored by the covered program.</text> </paragraph> <paragraph num="(b)"> <text>“Sexual abuse” includes sexual harassment and sexual assault.</text> </paragraph> <paragraph num="(c)"> <text>“Sexual abuse” does not include an action taken reasonably related to the provision of care, treatment, or services to an individual including:</text> <paragraph num="(i)"> <text>The performance of an accepted medical or behavioral procedure pursuant to and in accordance with orders of an appropriately qualified licensed health care professional; and</text> </paragraph> <paragraph num="(ii)"> <text>An action taken by a staff member that complies with applicable laws and policies on the use of physical intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Sexual act” means any of the following, if it can reasonably be construed to be for sexual arousal or gratification, or for the abuse of either party, and not for an accepted medical or behavioral purpose:</text> <paragraph num="(a)"> <text>An act in which an object or part of an individual’s body penetrates, however slightly, into another individual’s genital opening or anus;</text> </paragraph> <paragraph num="(b)"> <text>Intentional physical contact, or an attempt to make physical contact, either directly or through clothing, between the genitals, finger or fingers, hand or hands, or mouth of one individual and the genitals, groin, inner thigh, buttocks, anus, breast, or mouth of another individual;</text> </paragraph> <paragraph num="(c)"> <text>Intentional physical contact, or an attempt to make physical contact, between the tongue or mouth of one individual and any part of the body of another individual;</text> </paragraph> <paragraph num="(d)"> <text>The following nonphysical contacts:</text> <paragraph num="(i)"> <text>The intentional exposure by an individual to another of the individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast;</text> </paragraph> <paragraph num="(ii)"> <text>The intentional exposure by an individual to another of photographs of an individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast;</text> </paragraph> <paragraph num="(iii)"> <text>The intentional observation by an individual of another individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast;</text> </paragraph> <paragraph num="(iv)"> <text>Verbal or written description of, questions or suggestions regarding, or requests for any of the physical contacts described in §B(18)(a)—(c) of this regulation;</text> </paragraph> <paragraph num="(v)"> <text>Photographing, drawing, transmitting an image of, saving an image of, or recording the naked body or body parts of another individual;</text> </paragraph> <paragraph num="(vi)"> <text>Intentionally exposing an individual to photographs, pictures, drawings, diagrams, or other graphic depictions of naked body or body parts of an individual; and</text> </paragraph> <paragraph num="(vii)"> <text>Intentionally causing another individual to make or attempt any of the physical contacts described in §B(18)(a)—(c) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Other intentional acts directed to another individual and performed for the purpose of arousing sexual thoughts or feelings and not for purposes related to the provision of care.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Sexual assault” means any of the following:</text> <paragraph num="(a)"> <text>A sexual offense as defined in Criminal Law Article, Title 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Any other sexual act that is a crime under State or federal law.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Sexual harassment” means intimidation, bullying, or coercion of a sexual nature or unwelcome sexual advances, requests for sexual favors, and other verbal or physical conduct of a sexual nature that tends to create a hostile or offensive environment.</text> </paragraph> <paragraph num="(21)"> <text>“Staff member” means any individual employed by a covered program, whether contractually or permanently, and any individual who volunteers with, is a contractor for or consultant to, works as an intern or resident for, or otherwise is engaged by, the covered program at any facility or location in which services are provided to individuals.</text> </paragraph> <paragraph num="(22)"> <text>“State facility” means the following institutions operated by the Department:</text> <paragraph num="(a)"> <text>A psychiatric hospital, licensed pursuant to COMAR 10.07.01;</text> </paragraph> <paragraph num="(b)"> <text>An intermediate care facility for individuals with developmental disabilities licensed pursuant to COMAR 10.07.20;</text> </paragraph> <paragraph num="(c)"> <text>A forensic residential center, licensed pursuant to COMAR 10.07.13; and</text> </paragraph> <paragraph num="(d)"> <text>Regional institutes for children and adolescents licensed and operated pursuant to COMAR 10.07.04 and COMAR 10.21.06.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Treatment team” means the group of individuals at the covered program who, in accordance with applicable State and federal law and regulations, are responsible for the development and implementation of a plan of care for an individual receiving services from the covered program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Program Policies."> <paragraph num="A."> <text>This regulation applies to the following covered programs as defined in Regulation .02 of this chapter:</text> <paragraph num="(1)"> <text>State facilities;</text> </paragraph> <paragraph num="(2)"> <text>Vocational and day service programs;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric rehabilitation programs for adults and minors;</text> </paragraph> <paragraph num="(4)"> <text>Residential rehabilitation programs; and</text> </paragraph> <paragraph num="(5)"> <text>Supported employment programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A covered program shall ensure that the covered program adopts and enforces policies that:</text> <paragraph num="(1)"> <text>Prohibit inappropriate sexual behavior that occurs while an individual is receiving services from a covered program:</text> <paragraph num="(a)"> <text>Between a staff member and an individual served by the covered program; and</text> </paragraph> <paragraph num="(b)"> <text>On the premises of the covered program or at any off-premises activity sponsored by the covered program, between:</text> <paragraph num="(i)"> <text>Individuals served by the covered program; or</text> </paragraph> <paragraph num="(ii)"> <text>An individual served by the covered program and another individual or individuals;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Require reporting of inappropriate sexual behavior in accordance with the requirements of Regulations .05 and .06 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Provide for training of staff members and individuals receiving services in accordance with Regulation .04 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Training Requirements."> <paragraph num="A."> <text>This regulation applies to the following covered programs as defined in Regulation .02 of this chapter:</text> <paragraph num="(1)"> <text>State facilities;</text> </paragraph> <paragraph num="(2)"> <text>Vocational and day service programs;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric rehabilitation programs for adults and minors;</text> </paragraph> <paragraph num="(4)"> <text>Residential rehabilitation programs; and</text> </paragraph> <paragraph num="(5)"> <text>Supported employment programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A covered program shall include awareness and prevention training on inappropriate sexual behavior as part of the established orientation process for:</text> <paragraph num="(1)"> <text>Staff members; and</text> </paragraph> <paragraph num="(2)"> <text>Individuals receiving services from the covered program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The inappropriate sexual behavior awareness and prevention training module:</text> <paragraph num="(1)"> <text>May be provided by the covered program or its contractor; and</text> </paragraph> <paragraph num="(2)"> <text>Shall be pre-approved by the Developmental Disabilities Administration or Behavioral Health Administration, as applicable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staff member training conducted in accordance with this regulation shall:</text> <paragraph num="(1)"> <text>Include, but not be limited to:</text> <paragraph num="(a)"> <text>An overview of inappropriate sexual behavior, including:</text> <paragraph num="(i)"> <text>Types and definitions of inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(ii)"> <text>Trauma of inappropriate sexual behavior and its long-range effects;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Types and characteristics of inappropriate sexual behavior, including signs and symptoms of inappropriate sexual behavior;</text> </paragraph> <paragraph num="(c)"> <text>Risk screening, protection plans, and prevention and detection measures for State facilities in accordance with Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Mandated reporting procedures, including the requirements of Regulations .05 and .06 of this chapter, regarding inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(e)"> <text>Confidentiality of information as it applies to inappropriate sexual behavior;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be completed during new employee orientation;</text> </paragraph> <paragraph num="(3)"> <text>Be updated on an annual basis; and</text> </paragraph> <paragraph num="(4)"> <text>Be documented in the staff members’ personnel training files.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Training for Individuals.</text> <paragraph num="(1)"> <text>Training conducted in accordance with this regulation for individuals receiving services shall:</text> <paragraph num="(a)"> <text>Be offered in language and terms, and using methods, appropriate to the ability of the individual being served to understand;</text> </paragraph> <paragraph num="(b)"> <text>Include an element of peer training, unless disapproved by an individual’s treatment team for reasons that are documented in the individual’s records;</text> </paragraph> <paragraph num="(c)"> <text>Be tailored to the individual’s abilities;</text> </paragraph> <paragraph num="(d)"> <text>Be provided to an individual served by a covered program in two stages, as follows:</text> <paragraph num="(i)"> <text>Key facts regarding identifying inappropriate sexual behavior and how to report it shall be provided within 5 days after initiation of services to the individual; and</text> </paragraph> <paragraph num="(ii)"> <text>Comprehensive training as set out in this regulation shall be provided to the individual as soon as practical but no later than 6 months after initiation of services to the individual;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Be updated on an annual basis; and</text> </paragraph> <paragraph num="(f)"> <text>Be documented in the individual’s plan of care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Training conducted in accordance with this regulation for individuals receiving services shall include, but not be limited to:</text> <paragraph num="(a)"> <text>The individuals’ rights and responsibilities with regard to inappropriate sexual behavior, including the right to be free from retaliation and further harm for reporting inappropriate sexual behavior;</text> </paragraph> <paragraph num="(b)"> <text>Identifying and reporting inappropriate sexual behavior;</text> </paragraph> <paragraph num="(c)"> <text>Crisis intervention, as appropriate; and</text> </paragraph> <paragraph num="(d)"> <text>Referral resources and methods.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mandatory Reporting Requirements."> <paragraph num="A."> <text>This regulation applies to the following covered programs as defined in Regulation .02 of this chapter:</text> <paragraph num="(1)"> <text>Non-State operated residential treatment centers for emotionally disturbed children and adolescents;</text> </paragraph> <paragraph num="(2)"> <text>Vocational and day service programs;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric rehabilitation programs for adults and minors;</text> </paragraph> <paragraph num="(4)"> <text>Residential rehabilitation programs; and</text> </paragraph> <paragraph num="(5)"> <text>Supported employment programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A covered program shall comply with the reporting requirements of:</text> <paragraph num="(1)"> <text>COMAR 07.02.16.04;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 07.02.07.04;</text> </paragraph> <paragraph num="(3)"> <text>This regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Any other applicable law or regulation requiring the reporting of inappropriate sexual behavior.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Any staff member who observes, receives a complaint regarding, or otherwise has reason to believe that an individual has been subjected to inappropriate sexual behavior shall file a report with the program director promptly, but in no circumstances more than 1 working day, after becoming aware of the situation.</text> </paragraph> <paragraph num="D."> <text>Upon the receipt of a report made under §C of this regulation, the program director shall:</text> <paragraph num="(1)"> <text>Immediately ensure:</text> <paragraph num="(a)"> <text>The safety, security, privacy, and emotional support of the individual or individuals involved; and</text> </paragraph> <paragraph num="(b)"> <text>That any medically appropriate and necessary care is provided to the individual or individuals involved;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Report the incident within 1 working day after receiving the report to:</text> <paragraph num="(a)"> <text>The Behavioral Health Administration or the Developmental Disabilities Administration, or both, as applicable;</text> </paragraph> <paragraph num="(b)"> <text>The Office of Health Care Quality; and</text> </paragraph> <paragraph num="(c)"> <text>The State’s designated protection and advocacy agency.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Report the incident immediately, and in no circumstances more than 1 working day, after receiving the report to the appropriate law enforcement authorities if the reported inappropriate sexual behavior violates or may violate the law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The report made under §B(2) of this regulation shall be made using the form required by the Department.</text> </paragraph> <paragraph num="F."> <text>Promptly after completing an investigation of a report of inappropriate sexual behavior, the program director shall report the results of the investigation to:</text> <paragraph num="(1)"> <text>The Behavioral Health Administration or the Developmental Disabilities Administration in accordance with applicable reporting procedures required by the Department;</text> </paragraph> <paragraph num="(2)"> <text>The Office of Health Care Quality;</text> </paragraph> <paragraph num="(3)"> <text>The State’s designated protection advocacy agency; and</text> </paragraph> <paragraph num="(4)"> <text>The appropriate law enforcement authorities if the results of the covered program’s investigation indicate a violation of the law may have occurred, but the allegations were not initially reported pursuant to §D(3) of this regulation because the allegations, as initially reported, did not involve inappropriate sexual behavior that may violate the law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reporting Requirements for State Facilities."> <paragraph num="A."> <text>This regulation applies to State facilities.</text> </paragraph> <paragraph num="B."> <text>For purposes of this regulation, “discovery” means staff observes, receives a complaint from an individual or other source, or otherwise has reason to believe that inappropriate sexual behavior has occurred.</text> </paragraph> <paragraph num="C."> <text>A State facility shall comply with the reporting requirements of:</text> <paragraph num="(1)"> <text>COMAR 07.02.16.04;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 07.02.07.04;</text> </paragraph> <paragraph num="(3)"> <text>This chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Any other applicable law or regulation requiring the reporting of inappropriate sexual behavior.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Policies and Training.</text> <paragraph num="(1)"> <text>The facility shall adopt and enforce written policies and procedures for the reporting and investigation of inappropriate sexual behavior in accordance with the requirements set forth in this regulation and Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall provide training to staff members, upon hire and annually thereafter, regarding facility policies and procedures governing the prevention, reporting, and investigation of allegations of inappropriate sexual behavior in accordance with this regulation and Regulation .04 of this chapter, including:</text> <paragraph num="(a)"> <text>Understanding the provisions of the memorandum of understanding;</text> </paragraph> <paragraph num="(b)"> <text>Transporting individuals for medical care or to a SAFE exam, including how to support the individual during transportation and actions that may be taken to avoid the use of restraint;</text> </paragraph> <paragraph num="(c)"> <text>Preservation of evidence; and</text> </paragraph> <paragraph num="(d)"> <text>Counseling alleged victims, including regarding emergency contraception, prophylaxes for HIV or other sexually transmitted infections, and follow-up medical care or appointments.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reporting and Investigation of Inappropriate Sexual Behavior.</text> <paragraph num="(1)"> <text>Facility staff members shall notify the administrative head of the facility, or the designee, of an allegation of inappropriate sexual behavior, immediately, but no later than 24 hours, from staff’s discovery of the allegation.</text> </paragraph> <paragraph num="(2)"> <text>The notification required in §E(1) of this regulation shall be made on the form or in the manner designated by the Department.</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notification in §E(1) of this regulation, the administrative head of the facility, or their designee, shall, within 24 hours of staff’s discovery of the allegation, provide written notice of the allegation to the:</text> <paragraph num="(a)"> <text>Office of Health Care Quality;</text> </paragraph> <paragraph num="(b)"> <text>Central coordinator;</text> </paragraph> <paragraph num="(c)"> <text>State-designated protection and advocacy agency;</text> </paragraph> <paragraph num="(d)"> <text>Treatment teams of the individuals involved in the allegation; and</text> </paragraph> <paragraph num="(e)"> <text>Appropriate law enforcement agency as set forth in §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the administrative head of the facility or the central coordinator has a conflict of interest in receiving the notification, facility staff members shall report the incident to another individual designated by the facility in the event of such conflict of interest.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Notification to Law Enforcement.</text> <paragraph num="(1)"> <text>The facility shall notify the appropriate external law enforcement agency, within 24 hours of discovery by the facility, of:</text> <paragraph num="(a)"> <text>An allegation of sexual assault occurring on the facility premises or at any off-premises activity sponsored by the facility between individuals served by the facility or an individual served by the facility and another individual; or</text> </paragraph> <paragraph num="(b)"> <text>An allegation of inappropriate sexual behavior between a staff member and an individual served by the State facility, regardless of the location of the incident.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §F(1)(b) of this regulation, allegations of inappropriate sexual behavior that are not criminal shall be reported to the Department’s police force for further investigation.</text> </paragraph> <paragraph num="(3)"> <text>The Department’s police force shall refer the allegations to the administrative head of the facility for further investigation as appropriate.</text> </paragraph> <paragraph num="(4)"> <text>An individual shall be permitted to report an allegation of inappropriate sexual behavior that is not criminal to an external law enforcement agency or complete a statement of charges with the District Court commissioner.</text> </paragraph> <paragraph num="(5)"> <text>The Department police force may not investigate a report of inappropriate sexual behavior made to an external law enforcement agency in accordance with §F(1) of this regulation unless the external law enforcement agency declines to investigate the report or requests the assistance of the Department police force.</text> </paragraph> <paragraph num="(6)"> <text>Upon the receipt of the notification made under §E of this regulation, the treatment team or teams of the alleged victim and alleged perpetrator, if applicable, shall:</text> <paragraph num="(a)"> <text>Review and, if appropriate, update the risk assessment screens and protection plans of the individuals involved in the allegation in accordance with Regulation .07G of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Review and, if appropriate, revise the plans of care of the individuals involved in the allegation in accordance with Regulation .07G of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Notify the central coordinator of the results of the treatment team’s review and assessment under this subsection;</text> </paragraph> <paragraph num="(d)"> <text>Take other appropriate action to ensure:</text> <paragraph num="(i)"> <text>The safety, privacy, and emotional support of the individual or individuals involved; and</text> </paragraph> <paragraph num="(ii)"> <text>That any medically appropriate and necessary care is provided to the individual or individuals involved; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Document the reported allegations and the results of any investigation of the allegations in the record of the individuals involved.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The facility and Department police shall investigate allegations of inappropriate sexual behavior in accordance with the following requirements:</text> <paragraph num="(a)"> <text>A facility staff member or Department police officer may not participate in, or conduct, an investigation of an allegation of inappropriate sexual behavior if that staff member or officer, or the staff member’s immediate family member, was involved in the incident or incidents underlying the allegation; and</text> </paragraph> <paragraph num="(b)"> <text>The facility shall comply with applicable laws and regulations governing the confidentiality of an individual’s information.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Promptly after completing an investigation of a report of inappropriate sexual behavior, the facility shall report the results of the facility’s investigation to the:</text> <paragraph num="(a)"> <text>Appropriate unit of the Department as required by applicable statutes or regulations;</text> </paragraph> <paragraph num="(b)"> <text>Office of Health Care Quality; and</text> </paragraph> <paragraph num="(c)"> <text>State’s designated protection and advocacy agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Regional Institutes for Children and Adolescents.</text> <paragraph num="(1)"> <text>Allegations of inappropriate sexual behavior on the premises of a regional institute for children and adolescents that are not criminal shall be referred to the administrative head of the regional institute for children and adolescents for further investigation.</text> </paragraph> <paragraph num="(2)"> <text>Allegations of sexual assault and inappropriate sexual behavior between an individual and a staff member shall be reported under §F(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The regional institute for children and adolescents shall report allegations of inappropriate sexual behavior to Child Protective Services pursuant to COMAR 07.02.07.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Annual Report.</text> <paragraph num="(1)"> <text>The central coordinator shall report annually to the Deputy Secretary for the unit within the Department which oversees the operations of each State facility on the following:</text> <paragraph num="(a)"> <text>Development of polices and materials to implement the requirements of this regulation and Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Suggested revisions to the uniform assessment and reporting forms required in this regulation and Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Compliance with the assessment and reporting requirements of this regulation and Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Compliance with the training requirements of this regulation and Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Identification of barriers to compliance with the requirements of this regulation and Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(f)"> <text>Recommendations to improve prevention, detection, and response by State facilities to inappropriate sexual behavior.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A copy of the report shall be provided to the State designated protection and advocacy agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Additional Requirements for State Facilities."> <paragraph num="A."> <text>This regulation applies to State facilities.</text> </paragraph> <paragraph num="B."> <text>Screening and Prevention Policies.</text> <paragraph num="(1)"> <text>The facility shall adopt and enforce written policies and procedures for ensuring the facility screens for, and takes reasonable steps to mitigate, an individual’s risk of being subjected to, or the perpetrator of, inappropriate sexual behavior in accordance with the requirements set forth in this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall provide training to staff members, upon hire and annually thereafter, regarding:</text> <paragraph num="(a)"> <text>The policies and procedures governing the risk screening and protection plans; and</text> </paragraph> <paragraph num="(b)"> <text>Detection and prevention of inappropriate sexual behavior in accordance with this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall utilize a uniform risk assessment screening tool.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Required Processes Upon Admission to Facility.</text> <paragraph num="(1)"> <text>As soon as practicable, but no later than 3 business days after the individual’s admission, the facility shall make reasonable efforts to collect the individual’s medical and treatment records in accordance with §H of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall implement reasonable safety precautions upon the individual’s admission.</text> </paragraph> <paragraph num="(3)"> <text>Within 48 hours of the individual’s admission, clinical staff shall:</text> <paragraph num="(a)"> <text>Complete a risk assessment screen of the resident, in accordance with §D of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Complete a suicide risk assessment; and</text> </paragraph> <paragraph num="(c)"> <text>If necessary, modify the reasonable safety precautions to mitigate the risks identified in the risk assessment screen.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Within 5 days after the individual’s admission, the treatment team shall meet to:</text> <paragraph num="(a)"> <text>Review and, if appropriate, update the risk assessment screen;</text> </paragraph> <paragraph num="(b)"> <text>Determine if a protection plan is necessary, based upon review of the risk assessment screen and, if so, develop a protection plan, in accordance with §E of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Develop the initial plan of care in accordance with §F of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Risk Assessment Screen.</text> <paragraph num="(1)"> <text>To complete the risk assessment screen, clinical staff shall:</text> <paragraph num="(a)"> <text>Use the form required by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Interview the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Document the individual’s responses regarding:</text> <paragraph num="(i)"> <text>The individual’s history of trauma and other issues relevant to the individual’s risk of being subjected to, or the perpetrator of, inappropriate sexual behavior in the facility;</text> </paragraph> <paragraph num="(ii)"> <text>Whether the individual feels safe in the facility, including why or why not; and</text> </paragraph> <paragraph num="(iii)"> <text>What the individual believes would make them feel safe in the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the individual cannot be interviewed, the clinical staff shall document the reason on the risk assessment screen form.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Protection Plan.</text> <paragraph num="(1)"> <text>The treatment team shall develop a protection plan if the treatment team determines that it is necessary to mitigate the risk identified in the risk assessment screen.</text> </paragraph> <paragraph num="(2)"> <text>The protection plan shall be completed on the form required by the Department.</text> </paragraph> <paragraph num="(3)"> <text>If a protection plan is determined to not be necessary to mitigate the risk identified in the risk assessment screen, the rationale shall be documented in the risk assessment screen.</text> </paragraph> <paragraph num="(4)"> <text>If an individual in a State facility has a behavior plan that includes the elements required in a protection plan, the behavior plan shall satisfy the requirements of this regulation and shall be labeled as a behavior and protection plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Plan of Care.</text> <paragraph num="(1)"> <text>When developing the initial plan of care, the treatment team shall:</text> <paragraph num="(a)"> <text>Review and, if appropriate, update the risk assessment screen based upon the information available to the treatment team; and</text> </paragraph> <paragraph num="(b)"> <text>Include a protection plan, if appropriate, pursuant to §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The initial and all subsequent plans of care shall:</text> <paragraph num="(a)"> <text>Incorporate the risk assessment screen and, if applicable, the protection plan;</text> </paragraph> <paragraph num="(b)"> <text>Include consideration of the effect of trauma on the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Be authorized by a physician, psychiatrist, or other appropriately qualified person under applicable legal and operational standards.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The plan of care shall be reviewed at least every 3 months and whenever an individual’s risk assessment screen is updated.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Review and Update of Risk Assessment Screens and Protection Plans.</text> <paragraph num="(1)"> <text>The treatment team shall review the risk assessment screen, and update if necessary, every 3 months as part of the plan of care review.</text> </paragraph> <paragraph num="(2)"> <text>The risk assessment may be reviewed more frequently if warranted by any new allegation of inappropriate sexual behavior or if additional information regarding risk factors is received by the treatment team.</text> </paragraph> <paragraph num="(3)"> <text>The plan of care shall be reviewed when the risk assessment is updated.</text> </paragraph> <paragraph num="(4)"> <text>The protection plan shall be reviewed and updated as needed or whenever the risk assessment is updated and when the plan of care is reviewed.</text> </paragraph> <paragraph num="(5)"> <text>When reviewing the protection plan, the treatment team shall consider:</text> <paragraph num="(a)"> <text>Effectiveness of strategies to reduce risk;</text> </paragraph> <paragraph num="(b)"> <text>Whether new or modified strategies are warranted; and</text> </paragraph> <paragraph num="(c)"> <text>The individual’s desires regarding the protection plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Medical and Other Records.</text> <paragraph num="(1)"> <text>The facility shall designate the staff member or members responsible for collecting the individual’s medical records in accordance with this subsection.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall make reasonable and documented efforts to collect medical records from the individual’s prior and current health care providers in accordance with this subsection, including:</text> <paragraph num="(a)"> <text>Discharge summaries from all hospitals where the individual received treatment in the 3 years before the individual’s admission to the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Somatic and other health assessments performed in the 3 years before the individual’s admission to the facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The facility shall make reasonable and documented efforts to collect any other significant records identified by the facility that the treatment team determines are clinically necessary to develop and implement the individual’s plan of care.</text> </paragraph> <paragraph num="(4)"> <text>Facilities shall make reasonable and documented efforts to collect information from the following sources related to the individual’s risk for being a victim or perpetrator of inappropriate sexual behavior, provision of trauma-related care or treatment, or the individual’s reduced decision-making capacity, as authorized by law:</text> <paragraph num="(a)"> <text>Other State facilities;</text> </paragraph> <paragraph num="(b)"> <text>Local jails or detention centers and facilities operated by the Department of Public Safety and Correctional Services;</text> </paragraph> <paragraph num="(c)"> <text>The Department of Juvenile Services;</text> </paragraph> <paragraph num="(d)"> <text>Local Departments of Social Services, to identify other sources;</text> </paragraph> <paragraph num="(e)"> <text>Private hospitals and clinics; and</text> </paragraph> <paragraph num="(f)"> <text>Any persons known to the Department to have knowledge to identify other sources, including sources indicated on the responses to the risk assessment screen.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Facilities shall access records in electronic databases whenever possible and as such data bases become available.</text> </paragraph> <paragraph num="(6)"> <text>The facility shall comply with applicable laws and regulations governing the confidentiality and release of medical and other personal information pursuant to applicable State and federal laws and regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Internal Complaint Process."> <paragraph num="A."> <text>This regulation applies to the following covered programs as defined in Regulation .02 of this chapter:</text> <paragraph num="(1)"> <text>Vocational and day service programs;</text> </paragraph> <paragraph num="(2)"> <text>Psychiatric rehabilitation programs for adults and minors;</text> </paragraph> <paragraph num="(3)"> <text>Residential rehabilitation programs; and</text> </paragraph> <paragraph num="(4)"> <text>Supported employment programs;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A covered program shall:</text> <paragraph num="(1)"> <text>Adopt and maintain an internal complaint process as defined in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Provide a copy of the covered program’s written internal complaint process to each individual receiving services from the covered program:</text> <paragraph num="(a)"> <text>During the individual’s orientation; and</text> </paragraph> <paragraph num="(b)"> <text>At any time upon an individual’s request;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prominently display, in accessible, centralized locations, the covered program’s internal complaint process;</text> </paragraph> <paragraph num="(4)"> <text>Develop and maintain a form to use to make a complaint of inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(5)"> <text>Have available a staff member who is not involved in the alleged inappropriate sexual behavior to assist the individual in completing the complaint form.</text> </paragraph> </paragraph> <paragraph num="C."> <text>State facilities shall comply with the procedures set forth in COMAR 10.21.14.</text> </paragraph> <paragraph num="D."> <text>The internal complaint process shall:</text> <paragraph num="(1)"> <text>Provide procedures for making a complaint of inappropriate sexual behavior;</text> </paragraph> <paragraph num="(2)"> <text>Permit an individual alleging that the individual was subjected to inappropriate sexual behavior to use the covered program’s grievance process to address the alleged incident;</text> </paragraph> <paragraph num="(3)"> <text>Include procedures for investigating a complaint of inappropriate sexual behavior;</text> </paragraph> <paragraph num="(4)"> <text>Require that the covered program’s investigation of a complaint of inappropriate sexual behavior be completed within 7 calendar days after the investigation is initiated;</text> </paragraph> <paragraph num="(5)"> <text>Allow participation by:</text> <paragraph num="(a)"> <text>Representatives of, and as designated by, the individual who allegedly was subjected to the inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(b)"> <text>Any individual who is alleged to have committed the inappropriate sexual behavior;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Allow information to be presented to support the position of:</text> <paragraph num="(a)"> <text>The individual who allegedly was subjected to the inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(b)"> <text>Any individual who is alleged to have committed the inappropriate sexual behavior;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Ensure the participation of the covered program staff members who have the authority to implement corrective action;</text> </paragraph> <paragraph num="(8)"> <text>Require that the substance of the complaint and any actions taken in response to the complaint be documented; and</text> </paragraph> <paragraph num="(9)"> <text>Require written notification of the covered program’s determination to:</text> <paragraph num="(a)"> <text>The individual who allegedly was subjected to the inappropriate sexual behavior:</text> </paragraph> <paragraph num="(b)"> <text>Any individual who is alleged to have committed the inappropriate sexual behavior; and</text> </paragraph> <paragraph num="(c)"> <text>Appropriate covered program staff members or other individuals as necessary to take disciplinary or corrective action, or both.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Any staff member determined to have engaged in inappropriate sexual behavior shall be permitted to make use of the covered program’s internal grievance process in any disciplinary action based upon the determination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Confidentiality."> <text>State and federal confidentiality laws and regulations shall govern the redisclosure of information disclosed in all actions taken upon a report or complaint of inappropriate sexual behavior.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Effective Date."> <text>This chapter is effective January 1, 2015.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104, 7.5-205, 7-1002, and 10-705, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 23, 2015 (42:23 Md. R. 1433)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 27, 2021 (48:26 Md. R. 1110)</annotation> </annotations> </chapter> <chapter num="19" heading="" reason="Vacant" /> <chapter num="20" heading="Nursing Facility Quality Assessment"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to the collection by the Maryland Department of Health of a quality assessment, pursuant to Health-General Article, §19-310.1, Annotated Code of Maryland, to be paid on a quarterly basis by nursing facilities subject to the assessment.</text> </paragraph> <paragraph num="B."> <text>All amounts collected under this chapter shall be distributed to a special fund to be used by the Department only to fund reimbursements to nursing facilities under the Medicaid program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assessment” means the quality assessment paid on a quarterly basis by each nursing facility subject to this chapter, determined by the Department for each facility based upon an amount per non-Medicare day of service for the previous quarter of the State fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Medicaid” means the Medical Assistance Program in the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>Nursing Facility.</text> <paragraph num="(a)"> <text>“Nursing facility”, for purposes of this chapter, means a nursing facility, as defined in Health-General Article, §19-301, Annotated Code of Maryland, that has 45 or more beds, and operates in the State.</text> </paragraph> <paragraph num="(b)"> <text>“Nursing facility” does not include a continuing care retirement community that has obtained a certificate of registration to provide continuing care under Human Services Article, Title 10, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Collection of Nursing Facility Quality Assessment."> <paragraph num="A."> <text>On or before the 60th day after each quarter of the State fiscal year, each nursing facility subject to the quality assessment shall pay the specified amount into a bank account established under the authority of the State Treasurer.</text> </paragraph> <paragraph num="B."> <text>Late Charge.</text> <paragraph num="(1)"> <text>Payments not postmarked on or before the 60th day after each quarter are subject to an interest amount equal to the State of Maryland General Fund investment portfolio interest rate in effect at the time the payment is due.</text> </paragraph> <paragraph num="(2)"> <text>The late charge is a one-time imposition for each quarterly delinquent payment and shall equal the applicable interest rate multiplied by the quality assessment amount that is unpaid on the payment due date.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The amount of each facility's quarterly quality assessment shall equal the product of:</text> <paragraph num="(1)"> <text>The per diem assessment amount, as annually calculated by and provided to the facility by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>The number of non-Medicare days of care provided by the facility during the previous quarter of the State fiscal year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>With each quarterly quality assessment payment, each nursing facility paying the quality assessment shall report, on a form provided by the Department, the nursing facility's total number of patient days and non-Medicare patient days for that quarter.</text> </paragraph> <paragraph num="E."> <text>Effective July 1, 2012, the aggregated annual assessment collected under this chapter may not exceed 6 percent of the operating revenue for all nursing facilities subject to this assessment.</text> </paragraph> <paragraph num="F."> <text>The Department shall pursue collection and referral of unpaid quality assessments in accordance with the timetables and agency collection standards set forth in COMAR 17.01.01.04.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-310.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective December 27, 2010 (37:26 Md. R. 1786); November 28, 2011 (38:24 Md. R. 1501); February 18, 2013 (40:3 Md. R. 217)</annotation> </annotations> </chapter> <chapter num="21" heading="Medical Orders for Life-Sustaining Treatment (MOLST) Form — Procedures and Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets out the Medical Orders for Life-Sustaining Treatment (MOLST) form, instructions, and certain related procedures and requirements developed by the Maryland Department of Health, in conjunction with the Board of Physicians and the Maryland Institute for Emergency Medical Services Systems.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advance directive” has the meaning stated in Health-General Article, §5-601(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Assisted living program” has the meaning stated in COMAR 10.07.14.02.</text> </paragraph> <paragraph num="(3)"> <text>“Authorized decision maker” means the health care agent, guardian of the person, or surrogate decision maker who is making health care decisions on behalf of a patient in accordance with the Health Care Decisions Act, Health-General Article, §§5-601—5-618, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“EMS DNR order” means an emergency medical services do not resuscitate order as defined in Health-General Article, §5-601(i), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Guardian of the person” means a person appointed by a court to be a guardian of the person of a disabled individual in accordance with Estates and Trusts Article, §13-705, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Health care” has the meaning stated in Health-General Article, §4-301(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Health care agent” means an agent as defined in Health-General Article, §5-601(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Health Care Decisions Act” means Health-General Article, §§5-601—5-618, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Health care facility” has the meaning stated in Health-General Article, §5-608.1(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Health care provider” has the meaning stated in Health-General Article, §5-601(l), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Home health agency” has the meaning stated in COMAR 10.07.10.02.</text> </paragraph> <paragraph num="(12)"> <text>“Hospice” means a hospice care program as defined in COMAR 10.07.21.02.</text> </paragraph> <paragraph num="(13)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Kidney dialysis center” has the meaning stated in COMAR 10.05.04.01</text> </paragraph> <paragraph num="(15)"> <text>“Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Medical record” has the meaning stated in Health-General Article, §4-301(i), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Minor” means an individual younger than 18 years old who is not married, not the parent of a child, and not otherwise authorized by law to consent to medical treatment.</text> </paragraph> <paragraph num="(18)"> <text>“Nurse practitioner” has the meaning stated in Health-General Article, §5-601(p), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19)"> <text>“Nursing home” means a comprehensive care facility or extended care facility as defined in COMAR 10.07.02.01.</text> </paragraph> <paragraph num="(20)"> <text>Patient.</text> <paragraph num="(a)"> <text>Except as provided in §(20)(b), “patient” has the meaning stated in Health-General Article, §4-301(k), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Patient” does not include someone:</text> <paragraph num="(i)"> <text>Whose primary diagnosis for the current treatment is a psychiatric disorder, except for dementia, delirium, or mental disorders due to a medical condition;</text> </paragraph> <paragraph num="(ii)"> <text>Whose primary diagnosis is related to a current pregnancy; or</text> </paragraph> <paragraph num="(iii)"> <text>Who is younger than 18 years old and who is unlikely to require a life-sustaining treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Physician” has the meaning stated in Health-General Article, §5-601(r), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Physician assistant” has the meaning stated in Health-General Article, §5-601(s), Annotated Code of Maryland</text> </paragraph> <paragraph num="(23)"> <text>“Practitioner” means a physician, nurse practitioner, or physician assistant.</text> </paragraph> <paragraph num="(24)"> <text>“Substantial change in health status” means a change in a patient’s health or functional status that:</text> <paragraph num="(a)"> <text>Demonstrates an improvement or decline in the patient’s status that requires the need for interdisciplinary review or revision of the patient’s health care; and</text> </paragraph> <paragraph num="(b)"> <text>Is not a temporary change that is self-limited.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Surrogate” means an individual who makes health care decisions for a patient pursuant to Health-General Article, §5-605, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Nature and Contents of the MOLST Form and Instructions."> <text>The content of the form and the form’s instructions are as follows:</text> <text>FORM AT END OF CHAPTER.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Use of the MOLST Form."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Defined Terms.</text> <paragraph num="(a)"> <text>“Completing a MOLST form” means:</text> <paragraph num="(i)"> <text>Certifying, when applicable, the bases for the orders contained therein;</text> </paragraph> <paragraph num="(ii)"> <text>Completing section one for all patients and only those sections two through nine of the form that are related to the patient’s current medical condition and wishes for care; and</text> </paragraph> <paragraph num="(iii)"> <text>Signing and dating the MOLST form.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Updating a MOLST form” means to revise an existing MOLST form by voiding the existing form and completing a new MOLST form in accordance with the form’s instructions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Beginning July 1, 2013, the following health care facilities are required to accept, update if appropriate, and complete the MOLST form for each patient during the admission process in accordance with the form’s instructions:</text> <paragraph num="(1)"> <text>An assisted living program;</text> </paragraph> <paragraph num="(2)"> <text>A home health agency;</text> </paragraph> <paragraph num="(3)"> <text>A hospice;</text> </paragraph> <paragraph num="(4)"> <text>A kidney dialysis center; and</text> </paragraph> <paragraph num="(5)"> <text>A nursing home.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An assisted living program or a nursing home shall also complete the MOLST form for a patient:</text> <paragraph num="(1)"> <text>Admitted before January 1, 2013; and</text> </paragraph> <paragraph num="(2)"> <text>Who continues to reside in the assisted living program or nursing home after July 1, 2013.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Beginning July 1, 2013, a hospital shall:</text> <paragraph num="(1)"> <text>Accept and update if appropriate, a completed MOLST form in accordance with the form’s instructions; or</text> </paragraph> <paragraph num="(2)"> <text>Complete a MOLST form for a patient during the patient’s inpatient stay if the patient is to be discharged or transferred to another health care facility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>When initially completing a MOLST form or updating an existing MOLST form, a health care facility shall:</text> <paragraph num="(1)"> <text>Offer the patient or authorized decision maker the opportunity to participate in completing or updating the MOLST form, and on request of the patient, offer any physician, nurse practitioner , or physician assistant selected by the patient the opportunity to participate in updating or completing the MOLST form;</text> </paragraph> <paragraph num="(2)"> <text>Note in the medical record when a patient or an authorized decision maker declines to participate in completing or updating the MOLST form, indicating the date and time of discussion, with whom the form was discussed, and a summary of the discussion;</text> </paragraph> <paragraph num="(3)"> <text>Inform the competent patient or authorized decision maker that the MOLST form will become part of the medical record and can be accessed through the procedures used to access a medical record; and</text> </paragraph> <paragraph num="(4)"> <text>Give the patient or authorized decision maker a copy of the completed form within 48 hours or sooner if the patient is discharged or transferred.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A practitioner who completes or updates a MOLST form shall do so in accordance with the form’s instructions.</text> </paragraph> <paragraph num="G."> <text>Except as otherwise provided in the Health Care Decisions Act, a practitioner shall complete, or update a MOLST form in a manner that is consistent with:</text> <paragraph num="(1)"> <text>The known decisions of:</text> <paragraph num="(a)"> <text>A competent patient; or</text> </paragraph> <paragraph num="(b)"> <text>An authorized decision maker; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any known advance directive if the patient is incapable of making an informed decision.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Any individual may request that a health care facility complete a MOLST form on his or her behalf, even if completion of a MOLST form is not required under these regulations or otherwise required by law. A health care facility that completes a MOLST form under these circumstances shall provide a copy of the completed form within 48 hours to the individual requesting completion of the form.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Resolving Conflicts Between MOLST Forms."> <paragraph num="A."> <text>If the medical records of a patient contain more than one MOLST form, the orders contained in the most recent MOLST form shall be followed unless and until the form is updated.</text> </paragraph> <paragraph num="B."> <text>If MOLST forms completed on different dates contain conflicting orders, a health care provider shall:</text> <paragraph num="(1)"> <text>To the extent feasible, discuss any conflicts with the patient or authorized decision maker; and</text> </paragraph> <paragraph num="(2)"> <text>Complete an updated MOLST form to reflect the current wishes of the patient or authorized decision maker.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an updated MOLST form is completed, all older forms shall be voided in accordance with the form’s instructions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reproduction and Alteration of the MOLST Form."> <paragraph num="A."> <text>A health care provider may freely copy, store electronically, and subsequently print or otherwise reproduce the form.</text> </paragraph> <paragraph num="B."> <text>A health care provider may not alter the contents or format of the form.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Immunity."> <text>A health care provider that, in good faith, authorizes the provision, withholding, or withdrawing of treatment in furtherance of orders contained in a MOLST form is entitled to the immunity provided under Health-General Article, §5-609, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 5-608, 5-608.1, and 5-609, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 2013 (39:25 Md. R. 1612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> </annotations> </chapter> <chapter num="22" heading="Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of the Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants is to improve health care access for all Marylanders by recruiting and retaining health care providers in areas of Maryland with health care professional shortages through education loan repayments assistance to program participants.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Education loan” has the meaning stated in Health-General Article, §24-1701, Annotated Code of Maryland. </text> </paragraph> <paragraph num="(3)"> <text>“Eligible field of employment” has the meaning stated in Health-General Article, §24–1704, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Full-time” means an individual’s work week consists of 40 or more hours at an eligible practice site.</text> </paragraph> <paragraph num="(5)"> <text>“Guidelines” means the Maryland Loan Repayment Programs Guidelines and any subregulatory guidance established by the Department.</text> </paragraph> <paragraph num="(6)"> <text>“Medical resident” means an individual who has completed medical school and is participating in a post-graduate residency education program accredited by the Accreditation Council for Graduate Medical Education, or its successor, or the American Osteopathic Association, or its successor, who is not licensed to practice medicine in the State.</text> </paragraph> <paragraph num="(7)"> <text>“Participant” means an individual who has been offered a Program award and is under a service obligation with the Program.</text> </paragraph> <paragraph num="(8)"> <text>“Part-time” means an individual’s work week consists of between 20 to 39 hours at an eligible practice site.</text> </paragraph> <paragraph num="(9)"> <text>“Physician” has the meaning stated in Health-Occupations Article, §14-101, Annotated Code of Maryland, who practices medicine either full-time or part-time.</text> </paragraph> <paragraph num="(10)"> <text>“Physician assistant” has the meaning stated in Health-Occupations Article, §15-101, Annotated Code of Maryland, who practices full-time or part-time.</text> </paragraph> <paragraph num="(11)"> <text>“Practice site” means a site where a participant provides clinical services and fulfills their service obligation.</text> </paragraph> <paragraph num="(12)"> <text>“Primary care” has the meaning stated in Health-General Article, §24-1701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Program” means the Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants.</text> </paragraph> <paragraph num="(14)"> <text>“Promissory Note” means a contractual agreement between a participant and the Department describing disbursement methods, participant roles and responsibilities, compliance penalties, and other terms as determined by the Department.</text> </paragraph> <paragraph num="(15)"> <text>“Service Obligation Agreement” means a contractual agreement between a participant and the Department specifying participant service obligations, total and annual Program award amounts, required data and verifications, penalties for breach, and other terms as determined by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Eligibility."> <paragraph num="A."> <text>Eligibility. To be eligible for the program the individual shall:</text> <paragraph num="(1)"> <text>Meet the licensure requirements set forth in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Be a United States citizen or national;</text> </paragraph> <paragraph num="(3)"> <text>Be liable and personally owe educational debt;</text> </paragraph> <paragraph num="(4)"> <text>Have a valid employment contract with an eligible practice site in the State that will be in effect by the start of any service obligation to be fulfilled;</text> </paragraph> <paragraph num="(5)"> <text>Provide evidence of practice as either part-time or full-time at that eligible practice site;</text> </paragraph> <paragraph num="(6)"> <text>Practice full-time or part-time providing health care services at an eligible practice site, with at least 80 percent of time spent in direct patient care for a minimum of 45 weeks per year; and</text> </paragraph> <paragraph num="(7)"> <text>Utilize Program funds for the repayment of eligible education loans.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure Requirements. To be eligible for the program, an individual shall be one of the following:</text> <paragraph num="(1)"> <text>A physician possessing active and valid licensure without restrictions or encumbrances to practice Allopathic Medicine in the State;</text> </paragraph> <paragraph num="(2)"> <text>A physician possessing active and valid licensure without restrictions to or encumbrances to practice Osteopathic Medicine in the State;</text> </paragraph> <paragraph num="(3)"> <text>A physician assistant possessing active and valid licensure without restriction or encumbrances in the State; or</text> </paragraph> <paragraph num="(4)"> <text>A final year medical resident who is specializing in primary care and overseen by a postgraduate training program in the State.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Eligibility Restrictions. An individual may not be eligible for the Program if they have:</text> <paragraph num="(1)"> <text>A federal or state judgment lien;</text> </paragraph> <paragraph num="(2)"> <text>Defaulted on any federal or state payment obligations even if the governmental creditor now considers them to be in good standing;</text> </paragraph> <paragraph num="(3)"> <text>Breached a prior service obligation to federal, state, or local government or other entity, even if the obligation is subsequently satisfied;</text> </paragraph> <paragraph num="(4)"> <text>Any federal or non-federal debt written off as uncollectible or received a waiver of any service or payment obligation;</text> </paragraph> <paragraph num="(5)"> <text>Any outstanding contractual obligations for a health care professional service to the federal government, another state loan repayment program, or other entity unless those service obligations are completely satisfied prior to the commencement of the Program service obligation; and</text> </paragraph> <paragraph num="(6)"> <text>Received the two maximum awards for service obligations to the Program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Eligible Practice Sites. An eligible practice site shall:</text> <paragraph num="(1)"> <text>Be an eligible field of employment in accordance with Health-General Article, §24–1704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be physically located in the State;</text> </paragraph> <paragraph num="(3)"> <text>Provide services to all patients regardless of their ability to pay; and</text> </paragraph> <paragraph num="(4)"> <text>If the practice site charges for health care professional services:</text> <paragraph num="(a)"> <text>Charge at the usual and customary prevailing rate;</text> </paragraph> <paragraph num="(b)"> <text>Utilize a financial aid policy of discounts or sliding fee scale for individuals with limited incomes; and</text> </paragraph> <paragraph num="(c)"> <text>Accept reimbursement from Medicare, the Maryland Medical Assistance Program, and the Maryland Children’s Health Insurance Program, if applicable to the patient type.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Procedures."> <paragraph num="A."> <text>By the published deadlines, on the form designated by the Department, an applicant shall:</text> <paragraph num="(1)"> <text>Submit a complete application to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Facilitate submission of application components by all contributors; and</text> </paragraph> <paragraph num="(3)"> <text>Submit any supporting documentation as requested by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall disapprove an application if the application:</text> <paragraph num="(1)"> <text>Fails to provide sufficient information or comply with requested documentation;</text> </paragraph> <paragraph num="(2)"> <text>Has the appropriate documentation but is determined to be ineligible; or</text> </paragraph> <paragraph num="(3)"> <text>Does not satisfy the requirements established by law or the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Selection."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Assess applicant eligibility based on documentation received by the published deadline;</text> </paragraph> <paragraph num="(2)"> <text>Require from an applicant additional documentation or use independent verification means to verify information in the application; and</text> </paragraph> <paragraph num="(3)"> <text>Score an eligible application based on priority criteria in accordance with:</text> <paragraph num="(a)"> <text>Health-General Article, §24–1705, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The guidelines established by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall respond to an award offer by submitting all required documentation to the Department within 90 calendar days of notice of award.</text> </paragraph> <paragraph num="C."> <text>Failure of the applicant to provide required documentation shall result in:</text> <paragraph num="(1)"> <text>An application determined as ineligible; or</text> </paragraph> <paragraph num="(2)"> <text>Cancellation of any offered awards.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Appeal of Disapproval of Application.</text> <paragraph num="(1)"> <text>An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application.</text> </paragraph> <paragraph num="(2)"> <text>If an applicant submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Sustain or reverse the decision on the application; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the decision on the application has been sustained or reversed; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> <paragraph num="(4)"> <text>Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in:</text> <paragraph num="(a)"> <text>The appeal nullified and decision sustained;</text> </paragraph> <paragraph num="(b)"> <text>Hearing on the appeal not rescheduled; or</text> </paragraph> <paragraph num="(c)"> <text>Appropriate sanctions taken as deemed by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Award Distribution."> <paragraph num="A."> <text>The distribution of Program awards shall be based on the funding prioritization in accordance with Health-General Article, §24–1704(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Department shall prioritize funding for the repayment of education loans in accordance with Health-General Article, §24–1705(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department shall annually determine, based on the availability of funds:</text> <paragraph num="(1)"> <text>The maximum number of participants for the Program in each priority area; and</text> </paragraph> <paragraph num="(2)"> <text>The minimum and maximum amount of loan repayment assistance awarded.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The amount of award offered and paid shall not exceed the lesser of:</text> <paragraph num="(1)"> <text>The loan repayment amount specified in the Service Obligation Agreement; or</text> </paragraph> <paragraph num="(2)"> <text>A participant's total verified debt from eligible education loans.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Participant Obligation."> <paragraph num="A."> <text>A participant shall provide the Department with required documentation including:</text> <paragraph num="(1)"> <text>Lender verification of education loan balance;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of employer verification;</text> </paragraph> <paragraph num="(3)"> <text>A signed Promissory Note that includes:</text> <paragraph num="(a)"> <text>The disbursement methods utilized by the Department in the repayment of education loans;</text> </paragraph> <paragraph num="(b)"> <text>The roles and responsibilities of the participant in the disbursement of funds to the lender institution;</text> </paragraph> <paragraph num="(c)"> <text>Penalties for failing to comply with terms and conditions of agreements with the Department; and</text> </paragraph> <paragraph num="(d)"> <text>Other terms as determined by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Service Obligation Agreement that includes:</text> <paragraph num="(a)"> <text>Obligations of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Total and annual amounts of the Program award;</text> </paragraph> <paragraph num="(c)"> <text>Completion of data and verifications required by the Department;</text> </paragraph> <paragraph num="(d)"> <text>Penalties for breach of the Promissory Note and Service Obligation Agreements;</text> </paragraph> <paragraph num="(e)"> <text>Incorporation of the Promissory Note and Program Guidelines; and</text> </paragraph> <paragraph num="(f)"> <text>Other appropriate terms as determined by the Department; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>All other documentations as requested by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant shall:</text> <paragraph num="(1)"> <text>Continue to meet the eligibility requirements as stated in Regulation .03A and B of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Serve a minimum service obligation as stipulated in the Service Obligation Agreement with the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A final year medical resident shall:</text> <paragraph num="(1)"> <text>Meet all requirements set forth in §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Complete residency training in primary care, and begin their service obligation without interruption; and</text> </paragraph> <paragraph num="(3)"> <text>Fulfill all requirements of §B of this regulation once the service obligation commences.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Verification of Service Obligation Fulfillment."> <paragraph num="A."> <text>The Department shall verify annually during Program participation, the participant’s compliance with:</text> <paragraph num="(1)"> <text>The Program Promissory Note;</text> </paragraph> <paragraph num="(2)"> <text>The Service Obligation Agreement; and</text> </paragraph> <paragraph num="(3)"> <text>Any subregulatory guidelines developed by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant shall respond to annual verification by submitting all required documentation to the Department within 180 calendar days of request.</text> </paragraph> <paragraph num="C."> <text>The Department shall annually receive confirmation from the:</text> <paragraph num="(1)"> <text>Approved practice site that the participant provided services in the previous year and continues to practice at the practice site; and</text> </paragraph> <paragraph num="(2)"> <text>Lender institution that the participant has an outstanding education loan balance that is not in default.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For a medical resident in their final year of medical residence, prior to the disbursement of award payment for the first obligation cycle, the Department shall:</text> <paragraph num="(1)"> <text>Receive confirmation from the residency training program that the participant is specializing in primary care; and</text> </paragraph> <paragraph num="(2)"> <text>Follow the same verification procedures stated in §§A and B of this regulation once service obligations by the participant commences.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to provide required reverification documentation to the Department will constitute a breach of agreement with the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Breach of Agreement and Penalties."> <paragraph num="A."> <text>A participant's failure to comply with the Service Obligation Agreement and Promissory Note shall constitute a breach of agreement with the Department.</text> </paragraph> <paragraph num="B."> <text>A final year medical resident who fails to begin a service obligation at the start of the next obligation cycle following the completion of primary care residency training, shall be in breach of the Service Obligation Agreement and Promissory Note.</text> </paragraph> <paragraph num="C."> <text>Penalties for breach of agreement with the Department shall be stated in the Service Obligation Agreement and Promissory Note, and may include:</text> <paragraph num="(1)"> <text>Financial penalties dependent on the funding source of the award provided to the participant;</text> </paragraph> <paragraph num="(2)"> <text>The elimination of future eligibility for the Program; or</text> </paragraph> <paragraph num="(3)"> <text>Referral of the participant to the Maryland Board of Physicians for investigation of the participant's violation of breach of service obligation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Amendments to a Participant’s Service Obligation."> <paragraph num="A."> <text>Practice Site Transfer.</text> <paragraph num="(1)"> <text>The Department may consider practice site transfer requests during a participant’s service obligation period.</text> </paragraph> <paragraph num="(2)"> <text>A participant shall submit a site transfer request to the Department for consideration and receive approval of the site transfer from the Department prior to a participant’s separation from an approved practice site.</text> </paragraph> <paragraph num="(3)"> <text>A site transfer request may not be submitted until the second service obligation year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may consider deferment of a participant’s service obligation or payment obligation for up to 1 year, if determined by the Department that compliance by the participant with the terms and conditions of the Service Obligation Agreement would involve extreme hardship as evidenced through documentation provided to the Department.</text> </paragraph> <paragraph num="C."> <text>Any request by a participant for service obligation amendments shall follow the written process and procedures as established by the Department in subregulatory guidance.</text> </paragraph> <paragraph num="D."> <text>A decision made by the Department upon request for a service obligation amendment shall be final.</text> </paragraph> <paragraph num="E."> <text>The Department may consider cancellation of a participant service obligation with evidence under the following circumstances:</text> <paragraph num="(1)"> <text>Illness or injury that prohibits future possibility of service; or</text> </paragraph> <paragraph num="(2)"> <text>Death as determined by a death certificate or other conclusive evidence of death under State law.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24–1701—24-1708, ; and Health Occupations Article, §§14–207 and 15–206(c), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 2, 2026 (53:4 Md. R. 184)</annotation> </annotations> </chapter> <chapter num="23" heading="Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of the Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff is to improve access to care for all Marylanders by recruiting and retaining health care providers in health care professional shortage areas of Maryland through the provision of education loan repayment assistance to eligible participants in exchange for their service obligations.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Education loan” has the meaning stated in Health-General Article, §24-1901, Annotated Code of Maryland. </text> </paragraph> <paragraph num="(3)"> <text>“Eligible field of employment” has the meaning stated in Health-General Article, §24–1904, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Full-time” means an individual’s work week consists of 40 or more hours at an eligible practice site.</text> </paragraph> <paragraph num="(5)"> <text>“Guidelines” means the Maryland Loan Repayment Programs Guidelines and any subregulatory guidance established by the Department.</text> </paragraph> <paragraph num="(6)"> <text>“Nurse” has the meaning stated in Health-General Article, §24–1901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Nursing Support Staff” has the meaning stated in Health-General-Article, §24–1901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” means an individual who has been offered a Program award and is under a service obligation.</text> </paragraph> <paragraph num="(9)"> <text>“Part-time” means an individual’s work week consists of between 20 to 39 hours at an eligible practice site.</text> </paragraph> <paragraph num="(10)"> <text>“Practice site” means a site where a participant provides clinical services and fulfills their service obligation.</text> </paragraph> <paragraph num="(11)"> <text>“Program” means the Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff.</text> </paragraph> <paragraph num="(12)"> <text>“Promissory Note” means a contractual agreement between a participant and the Department describing disbursement methods, participant roles and responsibilities, compliance penalties, and other terms as determined by the Department.</text> </paragraph> <paragraph num="(13)"> <text>“Service Obligation Agreement” means a contractual agreement between a participant and the Department specifying participant service obligations, total and annual Program award amounts, required data and verifications, penalties for breach, and other terms as determined by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Eligibility."> <paragraph num="A."> <text>Eligibility. To be eligible for the Program, a nurse or nursing support staff shall:</text> <paragraph num="(1)"> <text>Be liable and personally owe education loan debt;</text> </paragraph> <paragraph num="(2)"> <text>Be a United States citizen or national;</text> </paragraph> <paragraph num="(3)"> <text>Have a valid employment contract with an eligible practice site in the State that will be in effect by the start of any service obligation to be fulfilled;</text> </paragraph> <paragraph num="(4)"> <text>Provide evidence of practice as either part-time or full-time at the eligible practice site;</text> </paragraph> <paragraph num="(5)"> <text>Practice full-time or part-time providing health care services at an eligible practice site, with at least eighty percent of time spent in direct patient care for at least a minimum of 45 weeks per year;</text> </paragraph> <paragraph num="(6)"> <text>Utilize Program funds for the repayment of eligible education loans; and</text> </paragraph> <paragraph num="(7)"> <text>Possess an active and valid certificate or license to practice nursing or fulfill a nursing support staff role in the State, without restrictions or encumbrances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility Restrictions. To be eligible for the Program, a nurse or nursing support staff may not have:</text> <paragraph num="(1)"> <text>Federal or State judgment liens;</text> </paragraph> <paragraph num="(2)"> <text>Defaulted on any federal or State payment obligations even if the governmental creditor now considers them to be in good standing;</text> </paragraph> <paragraph num="(3)"> <text>Breached a prior service obligation to federal, State, or local government or any other entity, even if the obligation is subsequently satisfied;</text> </paragraph> <paragraph num="(4)"> <text>Any federal or non-federal debt written off as uncollectible or received a waiver of any service or payment obligation;</text> </paragraph> <paragraph num="(5)"> <text>Any outstanding contractual obligations for health care professional service to the federal government, another state loan repayment program, or other entities unless those service obligations are completely satisfied prior to the commencement of the Program service obligation; and</text> </paragraph> <paragraph num="(6)"> <text>Received the two maximum awards for service obligations to the Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Eligible Practice Sites. An eligible practice site shall:</text> <paragraph num="(1)"> <text>Be an eligible field of employment in accordance with Health-General Article, §24–1904, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be physically located in the State;</text> </paragraph> <paragraph num="(3)"> <text>Provide services to all patients regardless of their ability to pay;</text> </paragraph> <paragraph num="(4)"> <text>If the practice site charges for health care professional services:</text> <paragraph num="(a)"> <text>Charge at the usual and customary prevailing rate;</text> </paragraph> <paragraph num="(b)"> <text>Utilize a financial aid policy of discounts or sliding fee scale for individuals with limited incomes; and</text> </paragraph> <paragraph num="(c)"> <text>Accept reimbursement from Medicare, the Maryland Medical Assistance Program, and the Maryland Children’s Health Insurance Program, if applicable to the patient type.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Procedures."> <paragraph num="A."> <text>By the published deadline, on the form designated by the Department, an applicant shall:</text> <paragraph num="(1)"> <text>Submit a complete application to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Facilitate submission of application components by all contributors; and</text> </paragraph> <paragraph num="(3)"> <text>Submit any supporting documentation as requested by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall disapprove an application if the application:</text> <paragraph num="(1)"> <text>Fails to provide sufficient information or comply with requested documentation;</text> </paragraph> <paragraph num="(2)"> <text>Has the appropriate documentation but is determined to be ineligible; or</text> </paragraph> <paragraph num="(3)"> <text>Does not satisfy the requirements established by law or the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Selection."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Assess applicant eligibility based on documentation received by the published deadline;</text> </paragraph> <paragraph num="(2)"> <text>Require from an applicant additional documentation or use independent verification means to verify information in the application; and</text> </paragraph> <paragraph num="(3)"> <text>Score an eligible application based on priority criteria in accordance with:</text> <paragraph num="(a)"> <text>Health-General Article, §24–1905, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The guidelines established by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall respond to an award offer by submitting all required documentation to the Department within 90 calendar days of notice of award.</text> </paragraph> <paragraph num="C."> <text>Failure of the applicant to provide required documentation shall result in:</text> <paragraph num="(1)"> <text>An application determined as ineligible; or</text> </paragraph> <paragraph num="(2)"> <text>Cancellation of any offered award.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Appeal of Disapproval of Application.</text> <paragraph num="(1)"> <text>An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application.</text> </paragraph> <paragraph num="(2)"> <text>If an applicant submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Sustain or reverse the decision on the application; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the decision on the application has been sustained or reversed; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> <paragraph num="(4)"> <text>Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in:</text> <paragraph num="(a)"> <text>The appeal nullified and decision sustained;</text> </paragraph> <paragraph num="(b)"> <text>Hearing on the appeal not rescheduled; or</text> </paragraph> <paragraph num="(c)"> <text>Appropriate sanctions taken as deemed by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Award Distribution."> <paragraph num="A."> <text>The distribution of program awards shall be based on the funding prioritization in accordance with Health-General Article, §24-1904.1(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Department shall prioritize funding for the repayment of education loans in accordance with Health-General Article, §24–1904.1(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department shall annually determine, based on the availability of funds:</text> <paragraph num="(1)"> <text>The maximum number of participants for the Program in each priority area; and</text> </paragraph> <paragraph num="(2)"> <text>The minimum and maximum amount of loan repayment assistance awarded.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The amount of award offered and paid shall not exceed the lesser of:</text> <paragraph num="(1)"> <text>The loan repayment amount specified in the Service Obligation Agreement; or</text> </paragraph> <paragraph num="(2)"> <text>A participant's total debt from eligible education loans.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Participant Obligation."> <paragraph num="A."> <text>A participant shall provide the Department with required documentation including:</text> <paragraph num="(1)"> <text>Lender verification of education loan balance;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of employer verification;</text> </paragraph> <paragraph num="(3)"> <text>A signed Promissory Note that includes;</text> <paragraph num="(a)"> <text>The disbursement methods utilized by the Department in the repayment of education loans;</text> </paragraph> <paragraph num="(b)"> <text>The roles and responsibilities of the participant in the disbursement of funds to the lender institution;</text> </paragraph> <paragraph num="(c)"> <text>Penalties for failing to comply with terms and conditions of agreements with the Department; and</text> </paragraph> <paragraph num="(d)"> <text>Other terms as determined by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Service Obligation Agreement that includes;</text> <paragraph num="(a)"> <text>Obligations of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Total and annual amounts of the Program award;</text> </paragraph> <paragraph num="(c)"> <text>Completion of data and verifications required by the Department;</text> </paragraph> <paragraph num="(d)"> <text>Penalties for breach of the Promissory Note and Service Obligation Agreements;</text> </paragraph> <paragraph num="(e)"> <text>Incorporation of the Promissory Note and Program Guidelines; and</text> </paragraph> <paragraph num="(f)"> <text>Other appropriate terms as determined by the Department; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>All other documentation as required by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant shall:</text> <paragraph num="(1)"> <text>Continue to meet the eligibility requirements as stated in Regulation 03A and B of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Serve a minimum service obligation as stipulated in the Service Obligation Agreement with the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Verification of Service Obligation Fulfillment."> <paragraph num="A."> <text>The Department shall verify annually during Program participation, the participant’s compliance with:</text> <paragraph num="(1)"> <text>The Program Promissory Note;</text> </paragraph> <paragraph num="(2)"> <text>The Service Obligation Agreement; and</text> </paragraph> <paragraph num="(3)"> <text>Any subregulatory guidelines developed by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant shall respond to annual verification by submitting all required documentation to the Department within 180 calendar days of request.</text> </paragraph> <paragraph num="C."> <text>The Department shall annually receive confirmation from the:</text> <paragraph num="(1)"> <text>Approved practice site that the participant provided services in the previous year and continues to practice at the practice site; and</text> </paragraph> <paragraph num="(2)"> <text>Lender institution that the participant has an outstanding education loan balance that is not in default.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Failure to provide required reverification documentation to the Department will constitute a breach of agreement with the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Breach of Agreement and Penalties."> <paragraph num="A."> <text>A participant's failure to comply with the Service Obligation Agreement and Promissory Note shall constitute a breach of agreement with the Department.</text> </paragraph> <paragraph num="B."> <text>Penalties for breach of agreement with the Department shall be stated in the Service Obligation Agreement and Promissory Note, and may include:</text> <paragraph num="(1)"> <text>Financial penalties dependent on the funding source of the award provided to the participant;</text> </paragraph> <paragraph num="(2)"> <text>The elimination of future eligibility for the Program; or</text> </paragraph> <paragraph num="(3)"> <text>Referral of the participant to the Maryland Board of Nursing for further disciplinary actions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Amendments to a Participant’s Service Obligation."> <paragraph num="A."> <text>Practice Site Transfer.</text> <paragraph num="(1)"> <text>The Department may consider practice site transfer requests during a participant’s service obligation period.</text> </paragraph> <paragraph num="(2)"> <text>A participant shall submit a site transfer request to the Department for consideration and receive approval of the site transfer from the Department prior to a participant’s separation from an approved practice site.</text> </paragraph> <paragraph num="(3)"> <text>A site transfer request may not be submitted until the second service obligation year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may consider deferment of a participant’s service obligation or payment obligation for up to 1 year if determined by the Department that compliance by the participant with the terms and conditions of the Service Obligation Agreement would involve extreme hardship as evidenced through documentation provided to the Department.</text> </paragraph> <paragraph num="C."> <text>Any request by a participant for service obligation amendments shall follow the written process and procedures as established by the Department in subregulatory guidance.</text> </paragraph> <paragraph num="D."> <text>A decision made by the Department upon request for a service obligation amendment shall be final.</text> </paragraph> <paragraph num="E."> <text>The Department may consider cancellation of a participant service obligation with evidence under the following circumstances:</text> <paragraph num="(1)"> <text>Illness or injury that prohibits future possibility of service; or</text> </paragraph> <paragraph num="(2)"> <text>Death as determined by a death certificate or other conclusive evidence of death under State law.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24–1901—24-1906, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 2, 2026 (53:4 Md. R. 185)</annotation> </annotations> </chapter> </subtitle> <subtitle num="02" heading="Division of Reimbursements"> <chapter num="01" heading="Charges for Services Provided Through the Maryland Department of Health"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>It is the intent of this chapter that:</text> <paragraph num="A."> <text>The cost of care of a recipient of services be determined in accordance with the charges for health services set under this chapter;</text> </paragraph> <paragraph num="B."> <text>There be a single or, if appropriate, bundled charge for each health service rendered to an individual, including an individual in a group session or family group session; and</text> </paragraph> <paragraph num="C."> <text>The methods for determining full costs be uniform among all units.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>All inpatient facilities operated by the Department;</text> </paragraph> <paragraph num="B."> <text>All local health departments' programs funded by the Department;</text> </paragraph> <paragraph num="C."> <text>All private or public alcohol and drug abuse providers funded by the Behavioral Health Administration;</text> </paragraph> <paragraph num="D."> <text>Adult day care funded by the Office of Health Services; and</text> </paragraph> <paragraph num="E."> <text>Family planning services funded by the Prevention and Health Promotion Administration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Charge” means the dollar amount set or approved by the Secretary for each clinic visit, day of care, hour, procedure, or other unit of service, as specified in the Schedule of Charges, which is the single rate to be charged all recipients of service, estates, third-party payers and insurers, or chargeable persons.</text> </paragraph> <paragraph num="(2)"> <text>“Chargeable person” means:</text> <paragraph num="(a)"> <text>Any responsible relative of a recipient of services;</text> </paragraph> <paragraph num="(b)"> <text>Except for a recipient of services, any other person who is legally responsible for the cost of care of the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Any person who maintains a policy of health insurance under which a recipient of services is insured.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“CPT” means a Current Procedural Terminology listing descriptive terms and identifying codes for reporting clinical services and procedures.</text> </paragraph> <paragraph num="(4)"> <text>“Daily per capita inpatient cost of care” means the cost of providing a day of care at a State-operated inpatient facility.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Division” means the Cost Accounting and Reimbursement Division of the Department.</text> </paragraph> <paragraph num="(7)"> <text>Federal Indirect Cost.</text> <paragraph num="(a)"> <text>“Federal indirect cost” means the cost the federal government recognizes as the costs of operating an inpatient facility that are not directly attributable to the operation of the inpatient facility.</text> </paragraph> <paragraph num="(b)"> <text>“Federal indirect cost” includes costs which benefit the Department as a whole and the inpatient facility indirectly, but cannot be readily identified with the inpatient facility without disproportionate effort.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Fee” means the charge or that part of the charge after an ability-to-pay determination or the elimination of disallowed costs by any third-party payer or insurer.</text> </paragraph> <paragraph num="(9)"> <text>“Health service” means any service for which a charge is established that is provided to any person, client, or resident in or by a unit of the Department, political subdivision, or grantee which is deemed appropriate by that unit to the care and treatment of an individual under its care or enrolled in its program.</text> </paragraph> <paragraph num="(10)"> <text>“Local health department” means a governmental agency that:</text> <paragraph num="(a)"> <text>Is funded wholly or partly by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Assumes legal and financial responsibility and accountability both for funds awarded by the Department and for the provision of health services; and</text> </paragraph> <paragraph num="(c)"> <text>Operates under the general direction of a health officer who is duly appointed by and reports to the Secretary pursuant to Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance ” means the Maryland Medical Assistance Program, which is administered by the State and pays the medical bills of certain needy and low-income individuals pursuant to Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, and 42 U.S.C. Chapter 7, Subchapter XIX.</text> </paragraph> <paragraph num="(12)"> <text>“Non-inpatient related costs” means costs at a State-operated facility which do not relate to the delivery of inpatient care.</text> </paragraph> <paragraph num="(13)"> <text>“Out-of-network services” means health services that are provided to a recipient of services which are not subject to payment at a negotiated rate under an agreement between the provider and a public or private third-party payer or insurer for the recipient of services.</text> </paragraph> <paragraph num="(14)"> <text>“Private provider” means:</text> <paragraph num="(a)"> <text>All private or non-local health department alcohol and drug abuse service providers funded by the Behavioral Health Administration;</text> </paragraph> <paragraph num="(b)"> <text>Adult day care service providers funded by the Office of Health Services; and</text> </paragraph> <paragraph num="(c)"> <text>Family planning service providers funded by the Prevention and Health Promotion Administration.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Provider” means a facility operated by:</text> <paragraph num="(a)"> <text>The Department;</text> </paragraph> <paragraph num="(b)"> <text>A local health department; or</text> </paragraph> <paragraph num="(c)"> <text>A private provider.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Recipient of Services.</text> <paragraph num="(a)"> <text>“Recipient of services” means an individual who receives care, maintenance, treatment, or support from a facility, clinic, local health department, program, or other entity that is operated or funded wholly or partly by the Department.</text> </paragraph> <paragraph num="(b)"> <text>“Recipient of services” includes, but is not limited to an individual:</text> <paragraph num="(i)"> <text>In a public facility under Health-General Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>In a facility or Veterans' Administration hospital for comprehensive evaluation under Health-General Article, Title 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>In a residential public facility or a facility from which this State obtains residential care under Health-General Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>To whom juvenile screening or treatment services are provided under Human Services Article, §9-227(b)(1)(ii), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Responsible relative” means one or more of the following who are legally responsible for the cost of care of a recipient of services:</text> <paragraph num="(a)"> <text>The spouse of the recipient of services;</text> </paragraph> <paragraph num="(b)"> <text>A parent of the recipient of services who is a minor; and</text> </paragraph> <paragraph num="(c)"> <text>An adult child of the recipient of services.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Schedule of charges” means a list of charges for health services as determined pursuant to instructions provided by the Division and this chapter, and set or approved by the Secretary.</text> </paragraph> <paragraph num="(19)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(20)"> <text>“Shared costs” means costs arising out of shared functions between two State-operated inpatient facilities.</text> </paragraph> <paragraph num="(21)"> <text>Statewide and Departmental Overhead.</text> <paragraph num="(a)"> <text>“Statewide and departmental overhead” means those costs incurred by the State and allocated to the facility which benefit the State-operated inpatient facility's operation as a whole, but are not related to the delivery of direct patient care.</text> </paragraph> <paragraph num="(b)"> <text>“Statewide and departmental overhead” includes costs that are usually incurred for a common purpose benefiting the State-operated inpatient facility which are not readily identified with the State-operated inpatient facility without disproportionate effort, such as Statewide accounting, purchasing, and personnel functions.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Third-party payer disallowance” means the difference between the charge and the payment amount authorized by an agreement between a provider and a public or private third-party payer or insurer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Setting of Charges for Local Health Departments."> <paragraph num="A."> <text>The Secretary shall approve a Schedule of Charges for each local health department containing the CPT-based charges for health services provided by the local health department which remain in effect until changed as provided in this chapter.</text> </paragraph> <paragraph num="B."> <text>CPT-Based Charge.</text> <paragraph num="(1)"> <text>Each health service for which payment is sought shall be assigned an applicable CPT code.</text> </paragraph> <paragraph num="(2)"> <text>Approved Method for Determining CPT-Based Charges.</text> <paragraph num="(a)"> <text>The CPT-based charge for each health service shall be equivalent to 150 percent of the Medicare participating provider fee allowance for the corresponding CPT code in the most recent Medicare Physician’s Fee Schedule for Maryland or the Washington, DC, suburbs, as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, in accordance with 42 U.S.C. §1395w-4.</text> </paragraph> <paragraph num="(b)"> <text>For any health service performed by a local health department for which a rate is not assigned in the applicable Medicare Physicians Fee Schedule, the CPT-based charge shall be equivalent to 150 percent of the Maryland Medical Assistance participating provider fee allowance for the corresponding CPT code in the Professional Services Provider Manual and Fee Schedule, as published by the Department and incorporated by reference in COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="(c)"> <text>For any health service performed by a local health department for which a rate is not assigned on the applicable Medicare Physicians Fee Schedule or in the Professional Services Provider Manual and Fee Schedule, the CPT-based charge shall be equivalent to the average hourly rate of the employees providing the service to the recipients of services, calculated based upon current fiscal year salaries and fringe benefits, multiplied by the projected time of service with recipient of services, plus 20 percent for indirect costs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Revisions and modifications to a Schedule of Charges shall be made and approved by the Secretary pursuant to instructions issued by the Division, provided that the Schedule of Charges for each local health department is updated and approved by the Secretary at least annually.</text> </paragraph> <paragraph num="D."> <text>Each approved Schedule of Charges, with all revisions and modifications, shall be retained by the Division and also be prominently posted at each location of the local health department where health services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Setting of Charges for State-Operated Inpatient Facilities."> <paragraph num="A."> <text>Inpatient Charge.</text> <paragraph num="(1)"> <text>For each fiscal year, a daily per capita inpatient cost of care for a State-operated inpatient facility shall be determined by:</text> <paragraph num="(a)"> <text>Utilizing the legislatively approved budget for the inpatient facility;</text> </paragraph> <paragraph num="(b)"> <text>Adding the federal indirect cost and Statewide and departmental overhead, less shared cost, for the applicable fiscal year; and</text> </paragraph> <paragraph num="(c)"> <text>Dividing the amount determined in §A(1)(b), of this regulation, by the average daily population of the facility for the applicable fiscal year to arrive at the daily per capita inpatient cost of care for the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The per diem inpatient charge shall equal the daily per capita inpatient cost of care as determined in §A(1)(c) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The per diem inpatient charge shall be set forth in the Schedule of Charges.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medicare-Eligible Patient Charge.</text> <paragraph num="(1)"> <text>For each fiscal year, a Medicare daily per capita inpatient cost of care for a State-operated inpatient facility shall be determined by:</text> <paragraph num="(a)"> <text>Utilizing the legislatively approved budget for the inpatient facility, minus the cost of physician and ancillary services for the inpatient facility;</text> </paragraph> <paragraph num="(b)"> <text>Adding the federal indirect cost and Statewide and departmental overhead, less shared cost, for the applicable fiscal year; and</text> </paragraph> <paragraph num="(c)"> <text>Dividing the amount determined in §B(1)(b), of this regulation, by the average daily population of the facility for the applicable fiscal year to arrive at the Medicare daily per capita inpatient cost of care for the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The per diem Medicare-eligible inpatient charge shall equal the Medicare daily per capita inpatient cost of care as determined in §B(1)(c) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The per diem Medicare-eligible inpatient charge shall be set forth in the Schedule of Charges.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physician Charge.</text> <paragraph num="(1)"> <text>For each fiscal year, a charge of physician services provided at a Medicare-eligible State-operated inpatient facility shall be determined by utilizing the most recent Facility Medicare Physicians fee schedule for Maryland or Washington, D.C., suburbs as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, pursuant to 42 U.S.C §1395w-4.</text> </paragraph> <paragraph num="(2)"> <text>The physician charge shall be set forth in the Schedule of Charges.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ancillary Charge.</text> <paragraph num="(1)"> <text>For each fiscal year, a charge for ancillary services provided at a Medicare-eligible State-operated inpatient facility shall be determined by utilizing the most recent Facility Medicare Physicians fee schedule for Maryland or Washington, D.C., suburbs as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, pursuant to 42 U.S.C §1395w-4.</text> </paragraph> <paragraph num="(2)"> <text>The ancillary charge shall be set forth in the Schedule of Charges.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for State-operated inpatient facilities shall be based on the best estimate of costs, including all appropriate indirect costs, according to generally accepted cost accounting practice. State-operated inpatient facilities, in support of the proposed Schedule of Charges, shall report the estimate of costs in the form required by the Secretary. When the dollar amount is set by statute, the Schedule of Charges shall specify that amount.</text> </paragraph> <paragraph num="F."> <text>Revisions and modifications to the approved Schedule of Charges to reflect changes in charges or the addition of new services shall be made when recommended by the Division and approved by the Secretary.</text> </paragraph> <paragraph num="G."> <text>The approved Schedule of Charges, with all revisions and modifications, shall be retained in the Office of the Secretary and also be available for public inspection in the Superintendent's office of the State-operated inpatient facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Setting of Charges for Private Providers."> <paragraph num="A."> <text>A private provider shall submit annually, to the Division, a cost report and proposed recommended Schedule of Charges, pursuant to instructions provided by the Division.</text> </paragraph> <paragraph num="B."> <text>At least annually, the Secretary shall approve a Schedule of Charges recommended for each private provider containing the per service charges for each private provider which remain in effect until changed as provided in this chapter.</text> </paragraph> <paragraph num="C."> <text>Per Service Charge. A charge for each service provided shall be determined for each private provider by:</text> <paragraph num="(1)"> <text>Calculating the actual cost for each type of service provided;</text> </paragraph> <paragraph num="(2)"> <text>Adjusting the actual cost determined in §C(1) of this regulation for depreciation and inflation, less equipment cost; and</text> </paragraph> <paragraph num="(3)"> <text>Dividing the amount determined in §C(2) of this regulation by the actual units of service provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a private provider's service charges are established by the Health Services Cost Review Commission (HSCRC), the requirements of §C of this regulation, do not apply.</text> </paragraph> <paragraph num="E."> <text>A private provider's proposed service charges shall be based on the best estimate of costs, according to generally accepted cost accounting practices, including all appropriate indirect costs. Private providers, in support of their proposed Schedule of Charges shall report their estimates pursuant to instructions provided by the Division. When specific service charges are set by statute, the Secretary shall approve these service charges consistent with the statute.</text> </paragraph> <paragraph num="F."> <text>Revisions and modifications to the approved Schedule of Charges to reflect changes in cost estimates or the addition or deletion of services for a private provider shall be made when recommended by the Division and approved by the Secretary.</text> </paragraph> <paragraph num="G."> <text>The approved Schedule of Charges for a private provider, with all revisions and modifications, shall be retained in the Division and also be prominently posted at each location of the private provider where services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Setting of Charges for Laboratories Administration."> <paragraph num="A."> <text>The Laboratories Administration shall submit annually, to the Division, a cost report and proposed recommended Schedule of Charges, pursuant to instructions provided by the Division.</text> </paragraph> <paragraph num="B."> <text>At least annually, the Secretary shall approve a Schedule of Charges recommended for each type of laboratory service which remains in effect until changed as provided in this chapter.</text> </paragraph> <paragraph num="C."> <text>Charge for a Laboratory Service. A laboratory service charge shall be determined by:</text> <paragraph num="(1)"> <text>Calculating the total cost of a type of laboratory test which may include, but is not limited to, salary and fringe benefits of staff dedicated to the type of laboratory service, and reagents, supplies, and equipment used in the type of laboratory service;</text> </paragraph> <paragraph num="(2)"> <text>Calculating the total number of units of each type of laboratory test performed; and</text> </paragraph> <paragraph num="(3)"> <text>Dividing the total cost of a type of laboratory test, as determined in §C(1) of this regulation, by the total number of units of each laboratory service, as determined in §C(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Revisions and modifications to the approved Schedule of Charges for the Laboratories Administration shall be made when recommended by the Division, and approved by the Secretary, to reflect changes in cost estimates or the addition of new laboratory services.</text> </paragraph> <paragraph num="E."> <text>The approved Schedule of Charges for the Laboratories Administration, with all revisions and modifications, shall be retained in the Office of the Secretary and also be posted prominently in the administrative offices of the Laboratories Administration.</text> </paragraph> <paragraph num="F."> <text>Notwithstanding the procedure for determining a laboratory service charge set forth in §C of this regulation, the Secretary may adjust the Schedule of Charges if deemed to be in the best interest of public health.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Determination of Ability to Pay and Fees to be Collected."> <paragraph num="A."> <text>For inpatient care rendered in facilities operated by the Department, fees shall be established in conformity with applicable statutory requirements and regulations issued by the Secretary. The following apply:</text> <paragraph num="(1)"> <text>The total cost of care of each recipient of services is, in the first instance, the responsibility of the recipient of services and also the chargeable person as provided in Health-General Article, §16-102(b), Annotated Code of Maryland. Any uncollectible costs for services provided to the recipient shall become the responsibility of the State.</text> </paragraph> <paragraph num="(2)"> <text>In accordance with the provisions of Health-General Article, §16-101 et seq., Annotated Code of Maryland, recipients of services and other chargeable persons shall be jointly and severally liable for payment of inpatient charges as set forth in the Schedule of Charges adopted by the Secretary pursuant to Regulation .05 of this chapter. The Department will bill all recipients of services and chargeable persons on the basis of their available financial resources including insurance and third-party payers, up to but not exceeding the full per capita daily charge for services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Outpatient and Community Based Services.</text> <paragraph num="(1)"> <text>For all other services, including outpatient and other community based services, the provisions of this section apply.</text> </paragraph> <paragraph num="(2)"> <text>All recipients of services and chargeable persons shall be liable for payment of the charges as set forth in the Schedule of Charges, subject to the following:</text> <paragraph num="(a)"> <text>For uninsured recipients of services, a waiver or reduction of charges may be granted on a case-by-case basis, following an individual determination of financial need of a recipient of services or chargeable person, based upon criteria set forth by the Secretary pursuant to §B(4) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>For insured, in-network recipients of services, liability for payment will be reduced to account for any contractually agreed upon third-party payer disallowance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Secretary shall issue and revise annually an ability-to-pay method and schedule for use in making an individualized determination of financial need of a recipient of services or chargeable person. The difference between the charge for the services rendered and the fee derived from this schedule shall be an ability-to-pay allowance.</text> </paragraph> <paragraph num="(4)"> <text>All local health departments and other providers shall use the uniform method of determining ability to pay as set forth by the Secretary.</text> </paragraph> <paragraph num="(5)"> <text>In those instances where only a portion of a provider's programs are subject to these regulations and a method of determining ability to pay different from that set forth by the Secretary is used, the different method may be used if approved by the Secretary.</text> </paragraph> <paragraph num="(6)"> <text>Any errors, omissions, or false statements or documents used in the determination of ability to pay or billing of any amounts due, may result in a redetermination of ability to pay and billing of any amounts due.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Billing and Collection of Charges and Fees."> <paragraph num="A."> <text>Billings and collections for care rendered in State operated inpatient facilities shall be calculated by the Department in accordance with the following procedures:</text> <paragraph num="(1)"> <text>The Department shall conduct a financial investigation of a recipient of services or chargeable persons' ability-to-pay in accordance with the requirements of COMAR 10.04.02.03 and COMAR 10.04.02.04;</text> </paragraph> <paragraph num="(2)"> <text>Based on the foregoing investigation, the Department shall prepare a Notice of Rate Establishment Form setting forth that portion of those charges for which the recipient of services or chargeable person shall be responsible;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the Notice of Rate Establishment, a recipient of services or chargeable person may, within 10 days, request the Division to conduct an informal review of the billing in accordance with COMAR 10.02.03.04, or may note an appeal from the billing in accordance with COMAR 10.02.03.05, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary may require each local health department and other provider to submit for approval or modification a plan for billing and collection of charges, fees, and insurance benefits.</text> </paragraph> <paragraph num="C."> <text>This plan shall set forth:</text> <paragraph num="(1)"> <text>The procedures to be followed in applying the ability-to-pay determination method and schedule;</text> </paragraph> <paragraph num="(2)"> <text>The methods to be used for collecting the charges, fees, and insurance benefits;</text> </paragraph> <paragraph num="(3)"> <text>The methods for receiving and accounting for all sums of money collected;</text> </paragraph> <paragraph num="(4)"> <text>The procedure to be followed in making a reasonable effort to collect unpaid amounts due; and</text> </paragraph> <paragraph num="(5)"> <text>The procedure to write off unpaid amounts due, as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Distribution and Application of Amounts Collected."> <paragraph num="A."> <text>All payments made under the provisions of this subtitle for services rendered through facilities and programs of the Department shall be made to and collected by the Department, and shall be accounted for and deposited into the General Funds of the State Treasury by the Department.</text> </paragraph> <paragraph num="B."> <text>Local health departments and other providers shall report all funds collected as revenues which are to be treated in accordance with Department or federal grant guidelines or other agreements and contracts under which their programs are funded.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Records and Reports Required."> <paragraph num="A."> <text>An individual financial record for each recipient of services or chargeable person shall be maintained, which shall contain relevant financial information including:</text> <paragraph num="(1)"> <text>The ability-to-pay determination, including, when available, applicable documents appropriate to the verification of assets, income, expenses, allowances and exemptions;</text> </paragraph> <paragraph num="(2)"> <text>The types and dates of services rendered and the approved charges, the amounts and dates of collections;</text> </paragraph> <paragraph num="(3)"> <text>An indication of the recipient of services eligibility for any federal program providing funding for the services rendered;</text> </paragraph> <paragraph num="(4)"> <text>A signed authorization to release medical information and assignment of third-party benefits;</text> </paragraph> <paragraph num="(5)"> <text>Any other information as may be required by the Secretary from time to time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Financial records of fees assessed and collected shall include:</text> <paragraph num="(1)"> <text>Copies of prenumbered receipts;</text> </paragraph> <paragraph num="(2)"> <text>Cash receipts report;</text> </paragraph> <paragraph num="(3)"> <text>Records of deposits; and</text> </paragraph> <paragraph num="(4)"> <text>Other records necessary for proper audit trail.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may waive any of the requirements of this section where appropriate upon written requests supported by reasons and justifications.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§16-201—16-407, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 6, 1976 (3:4 Md. R. 215)</annotation> <annotation type="History" subtype="Administrative History">Promulgated as emergency provision April 14, 1976 (3:11 Md. R. 586)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 amended effective July 21, 1976 (3:15 Md. R. 791)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 5, 1986 (13:9 Md. R. 1027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective March 18, 1985 (12:7 Md. R. 693); adopted permanently effective June 3, 1985 (12:11 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective November 14, 1985 (12:25 Md. R. 2468); adopted permanently effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 5, 1986 (13:9 Md. R. 1027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 23, 1987 (14:6 Md. R. 714); June 27, 1988 (15:13 Md. R. 1552); April 1, 1991 (18:6 Md. R. 685)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05A and .07A amended effective May 5, 1986 (13:9 Md. R. 1027)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 1, 1995 (22:15 Md. R. 1112); revised permanently effective October 9, 1995 (22:20 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective June 29, 1996 (23:15 Md. R. 1080); amended permanently effective November 4, 1996 (23:22 Md. R. 1496)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended as an emergency provision effective November 14, 1997 (24:25 Md. R. 1717); amended permanently effective February 23, 1998 (25:4 Md. R. 243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended as an emergency provision effective September 14, 1998 (25:21 Md. R. 1571); amended permanently effective December 28, 1998 (25:26 Md. R. 1923)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); revised permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 17, 2015 (42:15 Md. R. 1055)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="02" heading="Abandonment or Abuse of Responsible Relatives by Recipients of Care"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abandonment” means wrongful and continuous absence by a:</text> <paragraph num="(a)"> <text>Spouse from the home for a period of 18 months or longer, immediately before the recipient of services' hospitalization; or</text> </paragraph> <paragraph num="(b)"> <text>Parent coupled with failure to support a child, or children, for a period of 18 months or more during the child's or children's minority.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Abuse” or “physical abuse” means:</text> <paragraph num="(a)"> <text>The sustaining of physical injury;</text> </paragraph> <paragraph num="(b)"> <text>Cruel or inhumane treatment;</text> </paragraph> <paragraph num="(c)"> <text>A malicious act or treatment; or</text> </paragraph> <paragraph num="(d)"> <text>Harm, or threatened harm, to the health or welfare of the individual.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Crime of violence” means:</text> <paragraph num="(a)"> <text>Abduction;</text> </paragraph> <paragraph num="(b)"> <text>Arson;</text> </paragraph> <paragraph num="(c)"> <text>Burglary;</text> </paragraph> <paragraph num="(d)"> <text>Daytime housebreaking;</text> </paragraph> <paragraph num="(e)"> <text>Kidnapping;</text> </paragraph> <paragraph num="(f)"> <text>Manslaughter, except involuntary manslaughter;</text> </paragraph> <paragraph num="(g)"> <text>Assault in the first degree;</text> </paragraph> <paragraph num="(h)"> <text>Murder;</text> </paragraph> <paragraph num="(i)"> <text>Rape;</text> </paragraph> <paragraph num="(j)"> <text>Robbery;</text> </paragraph> <paragraph num="(k)"> <text>Robbery with a deadly weapon;</text> </paragraph> <paragraph num="(l)"> <text>Sexual offense in the first degree;</text> </paragraph> <paragraph num="(m)"> <text>Sexual offense in the second degree;</text> </paragraph> <paragraph num="(n)"> <text>Use of a handgun in the commission of a felony or other crime of violence;</text> </paragraph> <paragraph num="(o)"> <text>An attempt to commit any one of the following offenses:</text> <paragraph num="(i)"> <text>Assault with intent to murder;</text> </paragraph> <paragraph num="(ii)"> <text>Assault with intent to rape;</text> </paragraph> <paragraph num="(iii)"> <text>Assault with intent to rob;</text> </paragraph> <paragraph num="(iv)"> <text>Assault with intent to commit a sexual offense in the first degree; and</text> </paragraph> <paragraph num="(v)"> <text>Assault with intent to commit a sexual offense in the second degree.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Minority” means the period of time when a child is 17 years old or younger.</text> </paragraph> <paragraph num="(5)"> <text>“Recipient of services”:</text> <paragraph num="(a)"> <text>Means an individual who receives care, maintenance, treatment, or support in a facility or program that is operated or funded wholly or partly by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Includes, but is not limited to, an individual in a:</text> <paragraph num="(i)"> <text>Public facility under the Maryland Mental Law, Health-General Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Facility or Veteran's Administration hospital for comprehensive evaluation under Health-General Article, Title 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Residential, public facility, or a facility from which the State obtains residential care under the Maryland Developmental Disabilities Law, Health-General Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>Facility operated by the Office of Chronic and Rehabilitation Facilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Responsible relative” means the:</text> <paragraph num="(a)"> <text>Spouse of a recipient of services;</text> </paragraph> <paragraph num="(b)"> <text>Parents of a recipient of services who is a minor; and</text> </paragraph> <paragraph num="(c)"> <text>Children of a recipient of services.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Sexual abuse”:</text> <paragraph num="(a)"> <text>Means an act that involves sexual molestation or exploitation of a person by another person;</text> </paragraph> <paragraph num="(b)"> <text>Includes, but is not limited to:</text> <paragraph num="(i)"> <text>Incest, rape, or sexual offenses in any degree,</text> </paragraph> <paragraph num="(ii)"> <text>Sodomy, and</text> </paragraph> <paragraph num="(iii)"> <text>Unnatural or perverted sexual practices.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>It is the policy of the Maryland Department of Health, in accordance with:</text> <paragraph num="A."> <text>Health-General Article, §16-203(a)(3), Annotated Code of Maryland, to excuse a legally responsible relative from contributing to the cost of in-patient care of a recipient of services if that legally responsible relative has been abandoned by the recipient of services;</text> </paragraph> <paragraph num="B."> <text>Health-General Article, §16-203(a)(4), Annotated Code of Maryland, to excuse all legally responsible relatives from contributing to the cost of in-patient care of a recipient of services if that recipient of services has committed any of the following actions in relation to any legally responsible relative:</text> <paragraph num="(1)"> <text>Abuse or physical abuse;</text> </paragraph> <paragraph num="(2)"> <text>Crime of violence; or</text> </paragraph> <paragraph num="(3)"> <text>Sexual abuse.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Burden of Proof."> <paragraph num="A."> <text>A responsible relative claiming to have been abused, sexually abused, abandoned, or subjected to a crime of violence by the recipient of services shall have the burden of establishing to the satisfaction of the Department by a preponderance of the evidence that the legally responsible relative was abandoned, abused, sexually abused, or subjected to a crime of violence by the recipient of services.</text> </paragraph> <paragraph num="B."> <text>Acceptable evidence for abuse and crimes of violence includes, but is not limited to:</text> <paragraph num="(1)"> <text>Police reports; or</text> </paragraph> <paragraph num="(2)"> <text>Medical records, or medical statements prepared by a physician, physician's assistant, or nurse.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Acceptable evidence for abandonment includes, but is not limited to, affidavits from disinterested parties of the facts surrounding the abandonment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §16-203, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02B, and .03A amended effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C repealed effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective June 27, 1988 (15:13 Md. R. 1552)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 under a new chapter, Abandonment or Abuse of Responsible Relatives by Recipients of Care, adopted effective June 27, 1988 (15:13 Md. R. 1552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 17, 2005 (32:1 Md. R. 27)</annotation> </annotations> </chapter> <chapter num="03" heading="Appeal Hearings to the Division of Reimbursements"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Appellant” means any individual who requests an appeal hearing for the reasons specified in Regulation .02, of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Chargeable person” means any responsible relative and, except for a recipient of services, any other person who is legally responsible in an individual or representative capacity for the care of the individual.</text> </paragraph> <paragraph num="(4)"> <text>“Division” means the Division of Reimbursements of the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>Recipient of Services.</text> <paragraph num="(a)"> <text>“Recipient of services” means an individual who receives care, maintenance, treatment, or support in a facility or program that is operated or funded wholly or partly by the Department.</text> </paragraph> <paragraph num="(b)"> <text>“Recipient of services” includes, but is not limited to an individual:</text> <paragraph num="(i)"> <text>In a public facility under Health-General Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>In a facility or Veterans Administration hospital for comprehensive evaluation under the Health-General Article, Title 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>In a residential, public facility or a facility from which this State obtains residential care under Health-General Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>In a facility operated under Public Health Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Responsible relative” means the:</text> <paragraph num="(a)"> <text>Spouse of a recipient of services;</text> </paragraph> <paragraph num="(b)"> <text>Parents of a recipient of services who is a minor; and</text> </paragraph> <paragraph num="(c)"> <text>Children of a recipient of services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Opportunity for an Appeal Hearing."> <text>An opportunity for an appeal hearing shall be granted when:</text> <paragraph num="A."> <text>A rate is established (or increased) against an individual in an amount which is deemed by the individual to be arbitrary and excessive in accordance with the individual's financial circumstances;</text> </paragraph> <paragraph num="B."> <text>An individual is aggrieved by any division policy, action, or inaction:</text> <paragraph num="(1)"> <text>Which affects the charges established or manner of billing; or</text> </paragraph> <paragraph num="(2)"> <text>Results in an increase in the rates established;</text> </paragraph> </paragraph> <paragraph num="C."> <text>In the judgment of a recipient of services, responsible relative, or other chargeable person, he or she is adversely affected by any other Division policy, action, or inaction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notification of Right to Request an Appeal Hearing."> <paragraph num="A."> <text>Whenever the Division conducts an investigation of an individual's financial resources and issues a notice of rate establishment for services rendered to a recipient of services in accordance with COMAR 10.02.01.05, the Division shall provide written notification to the individual of his or her right to seek an informal review or an appeal, or both, from the rates established by the Division.</text> </paragraph> <paragraph num="B."> <text>The notification specified in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Advise the individual of the matters which are the proper subject of an appeal hearing as provided in Regulation .02, of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Advise the individual of his right to be represented by a lawyer or other person of his choice during the entire hearing process;</text> </paragraph> <paragraph num="(3)"> <text>Advise the individual that he may present witnesses and documents in his behalf at the hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Request for a Rate Review."> <paragraph num="A."> <text>If a recipient of services or other chargeable person submits a written request that the Division review the notice of rate establishment, the financial agent for the Division shall:</text> <paragraph num="(1)"> <text>Review the notice of rate establishment to determine the accuracy of the charges established;</text> </paragraph> <paragraph num="(2)"> <text>Review all pertinent information presented by the individual to determine if any adjustments in the billing are appropriate under these regulations;</text> </paragraph> <paragraph num="(3)"> <text>Provide the individual with a final billing statement which indicates both the:</text> <paragraph num="(a)"> <text>Division's position with regard to any written claims for a reduction in the rate established by the Division which are submitted by the individual to the financial agent; and</text> </paragraph> <paragraph num="(b)"> <text>Final rates established by the Division for services rendered to a recipient of services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The recipient of services or chargeable person shall have such rights as are set forth in Regulation .05, of this chapter, to request an appeal hearing regarding the Division's informal rate review and the charges for services established by it. In order to note an appeal from the charges established pursuant to the informal rate review, the recipient of services or chargeable person shall follow the procedures as set forth in Regulation .05, of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Request for an Appeal Hearing."> <paragraph num="A."> <text>Any individual, either himself or through a representative, may request an appeal hearing by giving a clear statement, in writing, to any financial agent of the Division that he desires an opportunity to present for review any matter which is the proper subject of an appeal hearing as provided in Regulation .02. This statement shall be forwarded immediately to the Chief of Reimbursements. When the Division receives a request for a hearing, it shall assist the appellant in submitting and processing the request.</text> </paragraph> <paragraph num="B."> <text>The Division shall promptly acknowledge any request for an appeal hearing and shall thereafter set forth in writing the date, time, and place of the appeal hearing, after consulting with the Office of Administrative Hearings. The acknowledgement shall include the information specified in Regulation .03B of this chapter.</text> </paragraph> <paragraph num="C."> <text>If any party notifies the Division that the time designated by the Division is not convenient to the party, and requests a different time for the hearing, the Office of Administrative Hearings shall designate another time convenient to the parties if it deems that the party has sufficient reason for requesting the change.</text> </paragraph> <paragraph num="D."> <text>A request for an appeal hearing may not be granted unless it is made within 30 days of the receipt of the notification specified in Regulation .03A of this chapter or, if Regulation .03A does not apply, within 30 days following the conclusion of the action or inaction which is the subject of the appeal.</text> </paragraph> <paragraph num="E."> <text>The Division may dismiss a request for an appeal hearing when it has been withdrawn in writing by the appellant or his representative, or abandoned. An appellant shall be deemed to have abandoned his request if he does not appear for the hearing on the established date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Pre-Hearing Procedures."> <text>The appellant and the Division may request the names of all witnesses that the other party intends to call at the hearing.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Hearing Procedures."> <paragraph num="A."> <text>The appellant and the Division shall have the opportunity to present witnesses, documentary evidence, and oral and written argument, and to cross-examine all adverse witnesses.</text> </paragraph> <paragraph num="B."> <text>If the appellant wishes to call as witnesses any of the Division's current employees, or former employees who reside within the State, whose action or inaction is being contested by the appellant or whose testimony is, in the judgment of the appellant, relevant to the issues under consideration, the Office of Administrative Hearings shall require their presence at the hearing. If the appellant has knowledge of the names or other identifying descriptions of the employees before the hearing, the appellant shall supply the Office of Administrative Hearings with the names or other identifying descriptions at least 5 days before the hearing. Subpoenas may be issued under COMAR 28.02.02.11.</text> </paragraph> <paragraph num="C."> <text>If the Division introduces, as evidence, documents from the case record, special investigation file, or other sources, the appellant shall have the opportunity to examine persons who prepared the documents and to examine the case record or special investigation file for the purpose of discovering information favorable to his case. If these persons are no longer employees of the Division, the appellant shall be permitted to examine a Division representative familiar with the documents and applicable Division policies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="The Record."> <paragraph num="A."> <text>A recording of the hearing shall be made. A copy of the recording shall be supplied to the appellant whenever the appellant takes a further appeal. The recording, together with all exhibits and papers admitted into evidence, shall constitute the exclusive record for decision. Nonrecorded or confidential information which the appellant does not have an opportunity to hear or see may not be made a part of the hearing record.</text> </paragraph> <paragraph num="B."> <text>The recording and copies of all exhibits and papers shall remain in the custody of the hearing officer for a period not to exceed 2 years, or until all litigation involving the decision is terminated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Findings, Conclusions and Decisions."> <paragraph num="A."> <text>The administrative law judge shall prepare a written summary of findings and conclusions, based exclusively on the record, and shall make a recommendation based on those findings and conclusions. The summary of findings and conclusions shall state the policies, regulations, or laws upon which the decision is based.</text> </paragraph> <paragraph num="B."> <text>A copy of the findings, conclusions and decisions shall be forwarded to the appellant or his representatives no later than 60 days after the date of the hearing.</text> </paragraph> <paragraph num="C."> <text>The recommendation of the administrative law judge, after approval by the Secretary of Health, shall be final and binding upon the Division and shall be implemented immediately unless otherwise specifically indicated in the decision. When the hearing decision is favorable to the appellant, or when the Division grants the relief the appellant requests before the hearing decision, the Division, where applicable, shall authorize corrected billing or other relief retroactive to the date the incorrect action was taken.</text> </paragraph> <paragraph num="D."> <text>The decision, if not favorable to the appellant, may be appealed to the Board of Review as provided by law in Health-General Article, §2-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>Subsequent appeals, as provided by law, may be taken by the appellant.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-207, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02C, and .03A amended effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, C amended effective June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective May 5, 1986 (13:9 Md. R. 1028); June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, C amended effective June 28, 1999 (26:13 Md. R. 1019)</annotation> </annotations> </chapter> <chapter num="04" heading="Schedule of Charges for Providers of the Alcohol and Drug Abuse Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746); September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528); August 3, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="05" heading="Schedules of Charges for Providers of the Drug Abuse Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective September 4, 1989 (16:17 Md. R. 1885)</annotation> </annotations> </chapter> <chapter num="06" heading="Schedules of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Laboratories Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277): repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="07" heading="Schedule of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Community and Public Health Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 3, 1989 (16:6 Md. R. 727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 1991 (18:14 Md. R. 1604); amended permanently effective September 30, 1991 (18:19 Md. R. 2099)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 10, 1987 (14:16 Md. R. 1773); October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 1992 (19:14 Md. R. 1311); emergency status extended at 19:20 Md. R. 1812; emergency status expired February 1, 1993</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 2, 1993 (19:26 Md. R. 2287); October 11, 1993 (20:20 Md. R. 1571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 1993 (20:14 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 1994 (21:13 Md. R. 1152); emergency status expired August 9, 1994 (21:18 Md. R. 1506)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective August 10, 1994 (21:18 Md. R. 1505); amended permanently effective November 20, 1994 (21:23 Md. R. 1933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 9, 1995 (22:20 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 1996 (23:14 Md. R. 1006); amended permanently effective October 7, 1996 (23:20 Md. R. 1422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended and new Regulations .04—.27 adopted as an emergency provision effective August 22, 1997 (24:19 Md. R. 1335); adopted permanently effective November 17, 1997 (24:23 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="08" heading="Schedule of Charges for Providers of the Mental Hygiene Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1927)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746); September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="09" heading="Schedules of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Mental Retardation Developmental Disabilities Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1927)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2659)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="10" heading="Schedules of Charges for Providers of the Office of Chronic and Rehabilitative Facilities" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 4, 1989 (16:17 Md. R. 1885)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 2001 (28:5 Md. R. 551)</annotation> </annotations> </chapter> <chapter num="11" heading="Schedule of Charges for Providers of the Medical Care Policy Administration" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1985 (12:20 Md. R. 1928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 3, 1989 (16:6 Md. R. 728)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2659); December 28, 1987 (14:26 Md. R. 2746); October 29, 1990 (17:21 Md. R. 2528); October 28, 1991 (18:21 Md. R. 2307)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 29, 1990 (17:21 Md. R. 2528)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551)</annotation> </annotations> </chapter> </subtitle> <subtitle num="03" heading="Health Statistics"> <chapter num="01" heading="Vital Records"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Amendment.</text> <paragraph num="(a)"> <text>“Amendment” means an alteration of or change to a vital record based on a court order or documentation specified in this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Amendment” includes more than one alteration of or change to a vital record, if the alterations or changes are specified in the same court order or the same request supported by documentation specified in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Amendment to change a name” means changing or altering any part of the name on a vital record.</text> </paragraph> <paragraph num="(3)"> <text>“Attending clinician” means the physician, nurse midwife, or direct-entry midwife in charge of a birth outside an institution.</text> </paragraph> <paragraph num="(4)"> <text>Authorized Representative.</text> <paragraph num="(a)"> <text>“Authorized representative” means a parent, guardian, or other representative of the subject of the vital record who presents evidence, satisfactory to the Secretary, that that individual is an authorized representative.</text> </paragraph> <paragraph num="(b)"> <text>“Authorized representative” includes but is not limited to:</text> <paragraph num="(i)"> <text>A member of the immediate or surviving family;</text> </paragraph> <paragraph num="(ii)"> <text>A direct ascendant or descendent;</text> </paragraph> <paragraph num="(iii)"> <text>An executor;</text> </paragraph> <paragraph num="(iv)"> <text>An attorney; or</text> </paragraph> <paragraph num="(v)"> <text>After October 1, 1999, a confidential intermediary or the Director of the Social Services Administration of the Department of Human Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Common carrier” means a public transportation business, line, or system which moves persons or goods from place to place. For the purpose of these regulations, “common carrier” does not include a funeral director's hearse or vehicle.</text> </paragraph> <paragraph num="(6)"> <text>“Confidential intermediary” means an individual or child placement agency qualified by the Director of the Social Services Administration of the Department of Human Services for the purpose of providing search, contact, and reunion services, as defined at §B(19) of this regulation.</text> </paragraph> <paragraph num="(7)"> <text>“Correction of a name” means altering the spelling of a name to eliminate an obvious misspelling, such as Jaon to Joan, or to eliminate a spelling contrary to the one used by the family, such as Smith to Smythe.</text> </paragraph> <paragraph num="(8)"> <text>“Dead body” means a lifeless human body or parts of a body or its bones from the condition of which it reasonably may be concluded that death has occurred. The term “dead body” does not apply to amputated parts.</text> </paragraph> <paragraph num="(9)"> <text>“Delayed birth registration” means registration of a birth when the child is more than 1 year old.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(11)"> <text>“Direct-entry midwife” means an individual licensed to practice direct-entry midwifery under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Electronic signature” means an electronic process associated with a record and executed by an individual with the intent to sign the record.</text> </paragraph> <paragraph num="(13)"> <text>“Fetal death” means death before the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy. The death is indicated by the fact that after the separation, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.</text> </paragraph> <paragraph num="(14)"> <text>“Filing” means the presentation of a certificate, report, or other record provided for in this subtitle, of a birth, death, fetal death, adoption, marriage, or divorce for registration by the Secretary.</text> </paragraph> <paragraph num="(15)"> <text>“Final disposition” means the burial, interment, cremation, or other disposition of a dead body or fetus.</text> </paragraph> <paragraph num="(16)"> <text>“Human remains” means a dead body or dead fetus for whom a death certificate is required to be filed under this chapter or Health-General Article, Title 4, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Institution” means any establishment, public or private:</text> <paragraph num="(a)"> <text>Which provides in-patient medical, surgical, or diagnostic care or treatment;</text> </paragraph> <paragraph num="(b)"> <text>Which provides nursing, custodial, or domiciliary care to two or more unrelated individuals; or</text> </paragraph> <paragraph num="(c)"> <text>To which persons are committed by law.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Live birth” means the complete expulsion or extraction from its mother of a product of human conception, irrespective of the period of gestation, which, after separation, breathes or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether the umbilical cord has been cut or the placenta is attached.</text> </paragraph> <paragraph num="(19)"> <text>“Mortician” means a funeral director and mortician as defined in Health Occupations Article, Title 7, Annotated Code of Maryland, or other person who is authorized to make final disposition of the human remains.</text> </paragraph> <paragraph num="(20)"> <text>“Nurse midwife” means an individual certified to practice as a nurse midwife under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Physician” means a person authorized or licensed to practice medicine in this State pursuant to the provisions of Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Physician Assistant” means an individual who is licensed under Health Occupations Article, Title 15, Annotated Code of Maryland, to practice medicine with physician supervision.</text> </paragraph> <paragraph num="(23)"> <text>“Registration” means the acceptance by the Secretary and the incorporation in the Department's official records of certificates, reports, or other records provided for in this subtitle, of births, deaths, fetal deaths, adoptions, marriages, or divorces.</text> </paragraph> <paragraph num="(24)"> <text>“Search, contact, and reunion service” means a service to:</text> <paragraph num="(a)"> <text>Locate adopted individuals and biological parents of adopted individuals;</text> </paragraph> <paragraph num="(b)"> <text>Assess the mutual desire for communication or disclosure of information between adopted individuals and biological parents of adopted individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provide, or provide referral to, counseling for adopted individuals and biological parents of adopted individuals.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(26)"> <text>“Vital records” means records of birth, death, fetal death, marriage, divorce, adoption, and adjudication of paternity required by law to be registered with the Secretary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Preparation of Certificates."> <paragraph num="A."> <text>An individual who prepares a birth, death, or fetal death certificate shall file the record using the electronic vital records registration system maintained by the Department unless otherwise directed by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Electronic registration may be phased in, as determined by the Secretary, until an electronic vital records registration system is fully implemented.</text> </paragraph> <paragraph num="C."> <text>An institution, mortician, or attending clinician filing fewer than 10 certificates in a calendar year may not be required to use an electronic vital records registration system.</text> </paragraph> <paragraph num="D."> <text>An individual who files a record using an electronic vital records registration system shall attest to the record’s accuracy by electronic signature.</text> </paragraph> <paragraph num="E."> <text>An individual who is required to file records via the electronic vital records registration system:</text> <paragraph num="(1)"> <text>Shall participate in training, as determined by the Secretary, on the proper use of the system; and</text> </paragraph> <paragraph num="(2)"> <text>May be required to successfully complete a certification test on the proper filing of vital records before being granted access to the system.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A record that is not prepared electronically shall be:</text> <paragraph num="(1)"> <text>Typed or written plainly in black unfading ink; and</text> </paragraph> <paragraph num="(2)"> <text>Signed in black unfading ink to attest to the accuracy of the record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Birth Registration."> <paragraph num="A."> <text>Birth Registration Notice.</text> <paragraph num="(1)"> <text>The Secretary may issue a birth registration notice to parents named on the certificate stating that the birth certificate of their child has been registered.</text> </paragraph> <paragraph num="(2)"> <text>The notification in §A(1) of this regulation may not be an official copy of a birth certificate but may be used for proof of age at the discretion of any reviewing agency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Name on Certificate.</text> <paragraph num="(1)"> <text>Amendment to Change a Name.</text> <paragraph num="(a)"> <text>The name of an individual born in this State may be changed on that individual's birth certificate once without a court order if, within 12 months of birth, the Department receives:</text> <paragraph num="(i)"> <text>A written request from both parents named on the certificate requesting the change of name; and</text> </paragraph> <paragraph num="(ii)"> <text>An affidavit from both parents sworn before a notary public stating that they are the true parents of the child and are making this request of their own free will.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A subsequent change to the name within 12 months of the birth shall require a court order.</text> </paragraph> <paragraph num="(c)"> <text>A change to the name after 12 months of the birth shall require a court order.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Correction of Spelling of the Name.</text> <paragraph num="(a)"> <text>A name on a birth certificate may be corrected to its proper spelling at any time upon proof that the name as shown on the birth certificate is incorrect and that the requested spelling is the proper spelling.</text> </paragraph> <paragraph num="(b)"> <text>Documentation required by §B(4) of this regulation shall be necessary proof for the change to be made.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Adding a Name.</text> <paragraph num="(a)"> <text>When a person has never had a first and last name placed on a birth record, a name may be added upon proof that the name is the name in use.</text> </paragraph> <paragraph num="(b)"> <text>If a first name has never been placed on a birth record by a parent and the last name is different than the name being used by the subject of the birth record, the Secretary shall replace the last name on the individual's birth certificate when adding the first name, if the individual provides proof that the name is the name used by the individual.</text> </paragraph> <paragraph num="(c)"> <text>Documentation required by §B(4) of this regulation shall be necessary proof for the addition of a name.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Documents Needed to Correct or Add a Name.</text> <paragraph num="(a)"> <text>If the subject of the vital record is under 7 years old, one or more of the following documents shall be submitted:</text> <paragraph num="(i)"> <text>A notarized letter from a parent citing the correct name;</text> </paragraph> <paragraph num="(ii)"> <text>A notarized letter from the hospital citing the correct name;</text> </paragraph> <paragraph num="(iii)"> <text>A notarized letter from the attendant at birth citing the correct name;</text> </paragraph> <paragraph num="(iv)"> <text>A notarized physician's office record of the birth citing the correct name.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Department reserves the right to require more than one of the documents listed in §B(4)(a) of this regulation to be submitted as sufficient proof.</text> </paragraph> <paragraph num="(c)"> <text>If the subject of the vital record is 7 years old or older, two or more of the following documents citing the correct name shall be submitted:</text> <paragraph num="(i)"> <text>Baptismal or other church records. To be acceptable, a baptismal record shall be an original certificate or book record made at the time of baptism, or a copy of the certificate or book record executed under church seal by the custodian of the church record, or a notarized statement attesting to the baptism and bearing the signature of the custodian of the church record or records.</text> </paragraph> <paragraph num="(ii)"> <text>Insurance policy.</text> </paragraph> <paragraph num="(iii)"> <text>Hospital or clinic record.</text> </paragraph> <paragraph num="(iv)"> <text>Physician's office record of the birth.</text> </paragraph> <paragraph num="(v)"> <text>Pre-kindergarten record or grade school record.</text> </paragraph> <paragraph num="(vi)"> <text>Family Bible record. The Bible shall be exhibited to the Secretary, State registrar, or local registrar for execution of a certificate of inspection upon a form supplied by the Secretary.</text> </paragraph> <paragraph num="(vii)"> <text>Record of employment.</text> </paragraph> <paragraph num="(viii)"> <text>Record of military service.</text> </paragraph> <paragraph num="(ix)"> <text>Marriage license.</text> </paragraph> <paragraph num="(x)"> <text>Record from federal census.</text> </paragraph> <paragraph num="(xi)"> <text>Birth certificate of a child of the subject of the vital record.</text> </paragraph> <paragraph num="(xii)"> <text>Social Security Administration record of the subject of the vital record's original application for a Social Security Number.</text> </paragraph> <paragraph num="(xiii)"> <text>Other pertinent records which meet the Secretary's approval and corroborate the name of the subject of the vital record.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The Department reserves the right to:</text> <paragraph num="(i)"> <text>Require more than two of the documents listed in §B(4)(c) of this regulation to be submitted as sufficient proof to correct or add a name;</text> </paragraph> <paragraph num="(ii)"> <text>Refuse to correct or add a name if the Department finds the documentation submitted unsatisfactory proof of the facts alleged.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Amending or Correcting Data on Birth Certificate Other than Name.</text> <paragraph num="(1)"> <text>To amend or correct data other than the name on a birth certificate, the following documents and information shall be submitted:</text> <paragraph num="(a)"> <text>For date of birth, time of birth, sex (other than changed by surgery), and place of birth of the subject of the vital record:</text> <paragraph num="(i)"> <text>A letter citing the correct data from the medical records director of the hospital in which the birth occurred;</text> </paragraph> <paragraph num="(ii)"> <text>A letter citing the correct data from the physician, nurse midwife, or attending clinician in attendance at birth; or</text> </paragraph> <paragraph num="(iii)"> <text>A notarized letter citing the correct data from an attendant at birth other than the one set forth in §C(1)(a)(ii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a parent’s data to be amended or corrected, at least two documents from among those listed below:</text> <paragraph num="(i)"> <text>Parent's birth certificate;</text> </paragraph> <paragraph num="(ii)"> <text>Parent’s baptismal or other church records (refer to specifications under §B(4)(c)(i) of this regulation);</text> </paragraph> <paragraph num="(iii)"> <text>Parent's pre-kindergarten or grade school records;</text> </paragraph> <paragraph num="(iv)"> <text>Other pertinent records which meet the Secretary's approval and corroborate the parent's data.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For a parent’s name to be replaced by another individual’s name, the individual requesting the replacement shall obtain an order from a court of competent jurisdiction that orders that:</text> <paragraph num="(i)"> <text>The currently listed parent’s name and any other information about that individual be deleted from the birth certificate; and</text> </paragraph> <paragraph num="(ii)"> <text>A specified individual’s name and other parent’s information as required for a birth certificate be added for the newly named individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department reserves the right to require additional documentation or to refuse to amend or correct information on a birth certificate if it finds the documentation submitted unsatisfactory proof of the facts alleged.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Method for Amending or Correcting Data on Birth Certificates.</text> <paragraph num="(1)"> <text>Amendments and corrections under this regulation shall be made by:</text> <paragraph num="(a)"> <text>Placing a line through the original data and entering new data in black ink; or</text> </paragraph> <paragraph num="(b)"> <text>Entering the amendment or correction on electronic media.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual who makes the amendment or correction shall:</text> <paragraph num="(a)"> <text>Record the date the correction or amendment was made;</text> </paragraph> <paragraph num="(b)"> <text>Record the microfilm number if the amendment or correction is made on a paper copy of a record; and</text> </paragraph> <paragraph num="(c)"> <text>Initial the record or provide an electronic signature.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Certificate for Adjudication of Paternity Record. If the child's name is to be changed, the court order or paternity decree shall state that the name is to be changed and provide the name as it is to appear on the record.</text> </paragraph> <paragraph num="F."> <text>Audit of Birth Records.</text> <paragraph num="(1)"> <text>All institutions that register births through the electronic vital records registration system shall be:</text> <paragraph num="(a)"> <text>Subject to an audit of the accuracy of the birth records they submit, at an interval determined by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>Required to make the medical records available for review by the auditor for comparison to the items captured on the birth record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All attending clinicians in charge of births outside an institution who register those births via the electronic vital records registration system shall be:</text> <paragraph num="(a)"> <text>Subject to an audit of the accuracy of the birth records they submit, at an interval determined by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>Required to make the medical records available for review by the auditor for comparison to the items captured on the birth record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Delayed Birth Registration."> <paragraph num="A."> <text>Certificate Form. Delayed birth registrations, certificates, and all copies of them shall include, in addition to other items:</text> <paragraph num="(1)"> <text>The word “DELAYED”, prominently printed;</text> </paragraph> <paragraph num="(2)"> <text>The date of filing; and</text> </paragraph> <paragraph num="(3)"> <text>An abstract of the supporting evidence, giving a description of the essential features of the documents and the relevant content of them (any inconsistencies shall be specifically noted).</text> </paragraph> </paragraph> <paragraph num="B."> <text>Acceptable Records.</text> <paragraph num="(1)"> <text>Documents listed under Regulation .03B(4) of this chapter are the records which may be submitted as proof of the facts alleged.</text> </paragraph> <paragraph num="(2)"> <text>The name, birth date, and birthplace shall be established by three supporting records.</text> </paragraph> <paragraph num="(3)"> <text>The parentage shall be established by at least one record.</text> </paragraph> <paragraph num="(4)"> <text>Supporting records shall be at least 3 years old unless the individual is under 7 years old.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Examination and Approval of Evidence.</text> <paragraph num="(1)"> <text>The supporting records shall be submitted to the Secretary for approval, provided that bulky records, difficult to transport, may be submitted to a local health officer or a notary public for execution of a certificate of inspection, upon a form to be provided by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>Supporting evidence may not be regarded as finally approved unless accepted by the Secretary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Cancellation of Records.</text> <paragraph num="(1)"> <text>When the Secretary is satisfied that a delayed birth certificate was obtained through fraud or misrepresentation, the Secretary shall send to the person named in the certificate a notice in writing of the intention to cancel the certificate. The notice shall give this person an opportunity to appear and show cause why the certificate should not be cancelled.</text> </paragraph> <paragraph num="(2)"> <text>The notice may be served on the person named in the certificate or, in the case of a minor or incompetent person, to the person's parent or guardian by forwarding the notice by registered mail to the person's last known address on file in the Department.</text> </paragraph> <paragraph num="(3)"> <text>Unless the person named in the certificate, or the parent or guardian, within 30 days after the date of mailing the notice, shows cause satisfactory to the Secretary why the certificate should not be cancelled, the Secretary shall cancel the certificate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Death Registration — Fetal Deaths."> <paragraph num="A."> <text>A certificate for fetal death of 20 or more weeks gestation shall be filed regardless of the disposition of the remains.</text> </paragraph> <paragraph num="B."> <text>If the gestation period is unknown, but the fetus weighs 350 grams or more, a fetal death certificate shall be filed.</text> </paragraph> <paragraph num="C."> <text>A certificate for fetal death under 20 weeks gestation need not be filed unless the fetus is transported from place of delivery for cremation or private burial.</text> </paragraph> <paragraph num="D."> <text>A fetal death certificate need not be filed if the gestation period is under 20 weeks and the remains are to be used for scientific or educational purposes by a hospital or other medical facility.</text> </paragraph> <paragraph num="E."> <text>A dead fetus of any length of gestation may be cremated by a hospital if:</text> <paragraph num="(1)"> <text>The hospital has the facilities;</text> </paragraph> <paragraph num="(2)"> <text>The hospital obtains the written permission from the responsible parent or parents; and</text> </paragraph> <paragraph num="(3)"> <text>The case is not required to be referred to the Medical Examiner.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When a fetus of 20 or more weeks gestation period is retained or cremated by a hospital, the hospital administrator shall enter his name on the certificate as the funeral director or the person acting as funeral director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Transportation of Human Remains — Burial-Transit Permit."> <paragraph num="A."> <text>The mortician who takes custody of human remains shall obtain a burial transit permit before final disposition or removal of the human remains from the State. The form of the burial-transit permit shall be prescribed by the Secretary.</text> </paragraph> <paragraph num="B."> <text>The burial transit permit shall accompany the human remains to their final destination.</text> </paragraph> <paragraph num="C."> <text>The individual required to provide the date and place of final disposition on a burial transit permit shall submit the information using the electronic vital records registration system maintained by the Department unless otherwise directed by the Secretary.</text> </paragraph> <paragraph num="D."> <text>When human remains are to be shipped by common carrier, the casket containing the human remains or the outer case shall be so constructed as to prevent seepage or escape of odors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disinterment and Reinterment Permits."> <paragraph num="A."> <text>When human remains are to be removed from a cemetery or other final resting place and transferred to another cemetery or location, a disinterment and reinterment permit shall be obtained from the local health department in Baltimore City or the county in which the human remains are located or the Maryland Department of Health. The form of this permit shall be prescribed by the Secretary. The Department or local health department may only issue a permit on written authorization from the State's Attorney of the jurisdiction in which the human remains are located or in compliance with a court order. If the human remains are moved to a grave or tomb within the same cemetery for relocation purposes only, a permit is not required.</text> </paragraph> <paragraph num="B."> <text>When it is required to disinter human remains for an autopsy purpose, even though the human remains are to be reinterred in the same cemetery, an application for a disinterment and reinterment permit shall be made to the local health department or Maryland Department of Health by the Medical Examiner, or by the State's Attorney of Baltimore City or any county of Maryland when acting in the State's Attorney's official capacity in investigating the death.</text> </paragraph> <paragraph num="C."> <text>When it is proposed to disinter and relocate a number of human remains, only one application shall be made by the mortician. The mortician shall submit with the application an original and copy of a list of the human remains to be disinterred. One disinterment and reinterment permit will be issued. The original of the list shall be attached to the permit and made a part of it, and a copy or electronic file of the list shall be retained by the local health department or Maryland Department of Health. If the names of human remains are not known, this fact shall be indicated on the application. The mortician shall include in the application an identification number, grave space grid number, or other means to identify every one of the human remains to be disinterred and reinterred.</text> </paragraph> <paragraph num="D."> <text>The application for a disinterment and reinterment permit shall be made on a form prescribed by the Secretary. Upon approval of the completed application, the Secretary, Commissioner of Health of Baltimore City, or the county health officer or their designees, depending on where the human remains are located, shall sign and issue a disinterment and reinterment permit to:</text> <paragraph num="(1)"> <text>An individual qualified in the interment of human remains, such as a mortician or cemeterian;</text> </paragraph> <paragraph num="(2)"> <text>An individual qualified in the funerary rites appropriate to the cultural affiliation of the human remains, such as a minister, priest, or other religious leader; or</text> </paragraph> <paragraph num="(3)"> <text>An anthropologist or archaeologist.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The disinterment and reinterment permit shall be endorsed by the cemetery authority from which the human remains are disinterred, and also by the cemetery authority in which the human remains are reinterred. The authority of the latter cemetery shall return the permit to the Maryland Department of Health, the Baltimore City Health Department, or the local health department within 10 days after reinterment if reinterment took place in a Maryland county or Baltimore City. If there is no cemetery authority, the mortician shall endorse the permit and return it to the appropriate health department within the time limit specified in this section.</text> </paragraph> <paragraph num="F."> <text>A disinterred coffin or casket containing human remains shall be so constructed or encased as to prevent seepage or escape of odors.</text> </paragraph> <paragraph num="G."> <text>Maintenance of Disinterment and Reinterment Permits.</text> <paragraph num="(1)"> <text>The Department and each local health department shall maintain a record of permits issued.</text> </paragraph> <paragraph num="(2)"> <text>A local health department shall provide documentation to the Department relating to a permit issued by the local health department.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall maintain an up-to-date electronic file of all permits issued in the State.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A disinterment and reinterment permit expires on the 30th day after the date of issuance.</text> </paragraph> <paragraph num="I."> <text>Except as provided in Health-General Article, §4-215(e)(5), Annotated Code of Maryland, the Department may not disclose or allow public inspection of information in a permit record about the location of the site of a disinterment or reinterment if a local burial sites advisory board or the Director of the Maryland Historical Trust determines that:</text> <paragraph num="(1)"> <text>The site is historic property, as defined in Article 83B, §5-601, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Disclosure would create a substantial risk of harm, theft, or destruction to the site.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inspection of Records and Disclosure of Information."> <paragraph num="A."> <text>On request, for birth, death, and marriage records only, the Secretary may disclose data or issue certified copies of vital records, original certificates, or information when satisfied that the applicant has a direct and tangible interest in the content of the record. For divorce records, the Secretary may only verify data or issue information when satisfied that the applicant has a direct and tangible interest in the content of the record.</text> </paragraph> <paragraph num="B."> <text>Evidence of Direct or Tangible Interest.</text> <paragraph num="(1)"> <text>In the case of birth records, a direct and tangible interest shall be evidenced by a request from:</text> <paragraph num="(a)"> <text>The subject of the vital record;</text> </paragraph> <paragraph num="(b)"> <text>A parent named on the birth certificate;</text> </paragraph> <paragraph num="(c)"> <text>The subject of the vital record's legal guardian;</text> </paragraph> <paragraph num="(d)"> <text>The surviving spouse of the subject of the vital record;</text> </paragraph> <paragraph num="(e)"> <text>An authorized representative of the subject of the vital record;</text> </paragraph> <paragraph num="(f)"> <text>A confidential intermediary authorized by the Director of the Social Services Administration of the Department of Human Services in accordance with Family Law Article, Title 5, Subtitle 3A or 4B, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(g)"> <text>The Director of the Social Services Administration of the Department of Human Services in accordance with Family Law Article, Title 5, Subtitle 3A or 4B, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(h)"> <text>An adoptee 21 years old or older who requests a copy of the adoptee's original certificate of birth, if the adoption was ordered by the court on or after January 1, 2000; or</text> </paragraph> <paragraph num="(i)"> <text>A biological parent of an adoptee 21 years old or older who requests a copy of the adoptee's original certificate of birth, if the adoption was ordered by the court on or after January 1, 2000.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the case of death or fetal death records, a direct and tangible interest shall be evidenced by a request from:</text> <paragraph num="(a)"> <text>Surviving relatives;</text> </paragraph> <paragraph num="(b)"> <text>An authorized representative;</text> </paragraph> <paragraph num="(c)"> <text>A person who is a beneficiary of the deceased;</text> </paragraph> <paragraph num="(d)"> <text>An individual who wishes to establish an estate in the name of the deceased;</text> </paragraph> <paragraph num="(e)"> <text>A person who paid to the deceased while the deceased was alive or who has paid to or is trying to pay to the deceased's beneficiaries insurance benefits, pension benefits, welfare benefits, or other benefits;</text> </paragraph> <paragraph num="(f)"> <text>A person who demonstrates to the Secretary that the individual is trying to carry out a legal duty that was the responsibility of the deceased;</text> </paragraph> <paragraph num="(g)"> <text>A person who presents a subpoena that commands that a copy of the record be produced, if the subpoena is issued by:</text> <paragraph num="(i)"> <text>A court;</text> </paragraph> <paragraph num="(ii)"> <text>An administrative body empowered by statute to issue a subpoena; or</text> </paragraph> <paragraph num="(iii)"> <text>A person empowered by statute to issue a subpoena;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>A person who is a party or who represents a party in litigation in which there is an issue as to whether the subject of the record is deceased;</text> </paragraph> <paragraph num="(i)"> <text>A person who needs to prove that a beneficiary who is the subject of the record is deceased;</text> </paragraph> <paragraph num="(j)"> <text>A person who needs to prove that the subject of the record is deceased so that a piece of property may be transferred with a clear title;</text> </paragraph> <paragraph num="(k)"> <text>A person who is a creditor of the deceased;</text> </paragraph> <paragraph num="(l)"> <text>A government official who provides documentation satisfactory to the Secretary that a requested death certificate is required in order to carry out the duties or functions of the official’s office; or</text> </paragraph> <paragraph num="(m)"> <text>A hospital official who requests information pertaining to a patient whose cancer diagnosis was reported by the official's hospital to the Maryland Cancer Registry.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the case of marriage records, the direct and tangible interest shall be evidenced by a request from:</text> <paragraph num="(a)"> <text>The married parties; or</text> </paragraph> <paragraph num="(b)"> <text>An authorized representative.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the case of information regarding divorce, a direct and tangible interest shall be evidenced by a request from:</text> <paragraph num="(a)"> <text>The divorced parties; or</text> </paragraph> <paragraph num="(b)"> <text>An authorized representative.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Birth Records in Cases of Adoption Involving a Confidential Intermediary.</text> <paragraph num="(1)"> <text>A confidential intermediary may apply to the Secretary for:</text> <paragraph num="(a)"> <text>The original certificate of birth and any records that relate to the new certificate of birth of an adopted individual;</text> </paragraph> <paragraph num="(b)"> <text>The new certificate of birth that was substituted for the original certificate of birth of an adopted individual under Health-General Article, §4-211, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>The report of the decree or judgment of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To apply for a copy of a record listed in §C(1) of this regulation, a confidential intermediary shall submit to the Secretary:</text> <paragraph num="(a)"> <text>A written application, as required by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>A written statement signed by the Director of Social Services or the Adoption Program Manager of the Department of Human Services and witnessed by a notary public that authorizes the confidential intermediary to obtain a copy of the requested record.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a confidential intermediary complies with the requirements set forth at §C(2) of this regulation, the Secretary shall give a copy of a requested record that is on file with the Secretary to the confidential intermediary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Birth Records for Adoptions Finalized on or after January 1, 2000.</text> <paragraph num="(1)"> <text>This section of this regulation:</text> <paragraph num="(a)"> <text>Applies only to adoptions finalized on or after January 1, 2000; and</text> </paragraph> <paragraph num="(b)"> <text>Does not bar:</text> <paragraph num="(i)"> <text>An adoptee or biological parent from applying for search, contact, and reunion services under Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>The Director of Social Services of the Maryland Department of Human Services or a confidential intermediary from obtaining a copy of a record under Family Law Article, §5-4B-04(c) or 5-4B-06(b) or (c), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An adoptee 21 years old or older may apply to the Secretary for:</text> <paragraph num="(a)"> <text>An uncertified copy of the adoptee's original certificate of birth;</text> </paragraph> <paragraph num="(b)"> <text>A copy of records that relate to the adoptee's new certificate of birth, if any; and</text> </paragraph> <paragraph num="(c)"> <text>A copy of the report of the adoptee's order of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an adoptee is 21 years old or older, a biological parent of the adoptee may apply to the Secretary for:</text> <paragraph num="(a)"> <text>An uncertified copy of the adoptee's original certificate of birth;</text> </paragraph> <paragraph num="(b)"> <text>A certified copy of the new certificate of birth, if any, that was substituted, under Health-General Article, §4-211, Annotated Code of Maryland, for the adoptee's original certificate of birth;</text> </paragraph> <paragraph num="(c)"> <text>A copy of all records that relate to the adoptee's new certificate of birth; and</text> </paragraph> <paragraph num="(d)"> <text>A copy of the report of the adoptee's order of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Secretary shall inform an applicant applying for a record as set forth in §D of this regulation of the availability of adoption search, contact, and reunion services, as set forth in Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>A person applying for a record under §C(1) and (2) of this regulation shall apply in writing on a form as required by the Secretary and shall submit the form with the individual's signature witnessed by a notary public.</text> </paragraph> <paragraph num="(6)"> <text>The Secretary shall give a copy of the requested record that is on file with the Secretary to the applicant, subject to the restrictions set forth at §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disclosure Vetoes.</text> <paragraph num="(1)"> <text>File with the Director of the Social Services Administration of the Maryland Department of Human Services a disclosure veto to bar disclosure of any information concerning the individual filing the disclosure veto in a record accessible under §D of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Cancel a disclosure veto at any time; and</text> </paragraph> <paragraph num="(3)"> <text>Refile a disclosure veto at any time.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Birth certificate information may not be disclosed if the information is to be used for commercial solicitation or private gain.</text> </paragraph> <paragraph num="G."> <text>Duties of the Secretary of Health.</text> <paragraph num="(1)"> <text>Subject to §G(3) and (4) of this regulation, the Secretary shall give to an applicant who meets the requirements of §D of this regulation a copy of each record that the applicant requests and that the Secretary has on file.</text> </paragraph> <paragraph num="(2)"> <text>When a biological parent applies for a record, the Secretary shall remove from the copy all information as to:</text> <paragraph num="(a)"> <text>The other biological parent, if that parent has filed a disclosure veto in accordance with §E of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The adoptee and each adoptive parent, if the adoptee has filed a disclosure veto in accordance with §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When an adoptee applies for a copy of a record, the Secretary shall remove from the copy of the record to be given to the adoptee all information as to the biological parent, if the biological parent has filed a disclosure veto in accordance with §E of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>The Secretary shall give the applicant for a birth record under §§C and D of this regulation:</text> <paragraph num="(a)"> <text>An uncertified copy of the birth certificate, if a birth certificate is requested; and</text> </paragraph> <paragraph num="(b)"> <text>A copy of a notice of the adoption search, contact, and reunion services available under Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Identification of Applicant Data. An applicant who applies for a vital record shall submit:</text> <paragraph num="(1)"> <text>A completed and signed application form, as provided by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>If applying in person, the original of, and if applying by mail, a copy of, proof of identify in the form of:</text> <paragraph num="(a)"> <text>One of the following valid, unexpired, government-issued documents that includes an expiration date:</text> <paragraph num="(i)"> <text>Driver's license;</text> </paragraph> <paragraph num="(ii)"> <text>Nondriver photo identification card; or</text> </paragraph> <paragraph num="(iii)"> <text>Passport;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A signed statement that the applicant does not have one of the identification documents set forth in §H(2)(a) of this regulation and, in addition to the signed statement, two of the following documents or copies of the following documents that contain the applicant's name and current address:</text> <paragraph num="(i)"> <text>Utility bill;</text> </paragraph> <paragraph num="(ii)"> <text>Car registration form;</text> </paragraph> <paragraph num="(iii)"> <text>Pay stub;</text> </paragraph> <paragraph num="(iv)"> <text>Bank statement;</text> </paragraph> <paragraph num="(v)"> <text>Income tax return;</text> </paragraph> <paragraph num="(vi)"> <text>Income tax W-2 form;</text> </paragraph> <paragraph num="(vii)"> <text>Lease or rental agreement; or</text> </paragraph> <paragraph num="(viii)"> <text>Letter from a government agency requesting a copy of a vital record; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A signed statement that the applicant does not have the identification documents set forth in §H(2)(a) and (b) of this regulation and, in addition to the signed statement, a document other than the ones set forth in §H(2)(a) and (b) of this regulation that allows the Secretary to corroborate the identity of the applicant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Fees Collected by the Department.</text> <paragraph num="(1)"> <text>The Department shall collect a $12 fee when the Department:</text> <paragraph num="(a)"> <text>Issues a certified or abridged copy of a:</text> <paragraph num="(i)"> <text>Death certificate provided concurrently with an initial requested death certificate;</text> </paragraph> <paragraph num="(ii)"> <text>Fetal death certificate;</text> </paragraph> <paragraph num="(iii)"> <text>Marriage certificate;</text> </paragraph> <paragraph num="(iv)"> <text>Verification of divorce certificate;</text> </paragraph> <paragraph num="(v)"> <text>Certificate of foreign birth; or</text> </paragraph> <paragraph num="(vi)"> <text>Certificate of birth resulting in stillbirth; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Issues a report that a search of the fetal death, marriage, or divorce files was made and a requested record is not on file;</text> </paragraph> <paragraph num="(c)"> <text>Makes an amendment to a fetal death or marriage certificate pursuant to a request made more than 1 year after the certificate was registered with the Department; or</text> </paragraph> <paragraph num="(d)"> <text>Processes an adoption, foreign adoption, or legitimation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall collect a $10 fee when the Department:</text> <paragraph num="(a)"> <text>Issues a certified or abridged copy of:</text> <paragraph num="(i)"> <text>A birth certificate; or</text> </paragraph> <paragraph num="(ii)"> <text>The first copy of a death certificate issued in a single transaction;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Issues a report that a search of the birth or death certificate files was made and a requested record is not on file; or</text> </paragraph> <paragraph num="(c)"> <text>Makes an amendment to a birth or death certificate pursuant to a request made more than 1 year after the certificate was registered with the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Fees Collected by Local Health Departments.</text> <paragraph num="(1)"> <text>A local health department that issues birth certificates shall set and collect a fee for processing and issuing:</text> <paragraph num="(a)"> <text>A birth certificate; or</text> </paragraph> <paragraph num="(b)"> <text>A report that a search of the files was made and the requested record is not on file.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>From the fee collected for providing a certificate or report under §J(1) of this regulation, the local health department shall transfer $10 to the General Fund of the State.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Verification Requests. A federal, State, county, municipal government agency, or an accredited private social or welfare agency entitled to access to vital records may be charged a fee for verification of the data in this regulation.</text> </paragraph> <paragraph num="L."> <text>Certified Copies. Copies of records shall be only from original records on file with the Secretary. When a certified copy is issued, each certification shall contain:</text> <paragraph num="(1)"> <text>A statement that it is a true copy of a record on file with the Secretary;</text> </paragraph> <paragraph num="(2)"> <text>The date issued;</text> </paragraph> <paragraph num="(3)"> <text>The registrar's signature; and</text> </paragraph> <paragraph num="(4)"> <text>The seal of the Secretary.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Reproduction of Certificates Permitted. A person or agency may photocopy a certified copy of a birth, death, fetal death, or marriage certificate for any nonfraudulent and nondeceptive purpose.</text> </paragraph> <paragraph num="N."> <text>Statistical or Research Use of Vital Records Data. The Secretary may permit use of data on vital records for statistical or research purposes, subject to conditions the Secretary may impose to ensure that the use of the data is limited to the purposes in this section.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Inspection of Records and Disclosure of Information — Maryland Certificate of Foreign Birth."> <paragraph num="A."> <text>The Secretary shall prepare and register a Maryland certificate of foreign birth upon a request that the certificate be prepared from the court, an adopting parent, or an adopted individual 18 years old or older, if the adoption took place:</text> <paragraph num="(1)"> <text>Through a court of competent jurisdiction in this State; or</text> </paragraph> <paragraph num="(2)"> <text>Under the laws of a jurisdiction or country other than the United States:</text> <paragraph num="(a)"> <text>By an adopting parent who is a resident of this State; and</text> </paragraph> <paragraph num="(b)"> <text>With an IR-3 visa or IH-3 visa being granted to the adopted individual by the United States Immigration and Naturalization Service under the Immigration and Nationality Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In order for the Secretary to prepare a Maryland certificate of foreign birth pursuant to §A(2) of this regulation, a person shall provide to the Secretary:</text> <paragraph num="(1)"> <text>An application form, as provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>An official and authenticated copy with valid stamps and seals of the adoption decree from the foreign jurisdiction or country where the adopted individual was adopted;</text> </paragraph> <paragraph num="(3)"> <text>A certified translation of the foreign adoption decree, if the decree is not in English;</text> </paragraph> <paragraph num="(4)"> <text>Proof of the date and place of the adopted individual's birth, as set forth in §C(1) of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Proof of the IR-3 visa or IH-3 visa status of the adopted individual; and</text> </paragraph> <paragraph num="(6)"> <text>Proof that the adopting parent is a resident of this State, as set forth in §C(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To provide proof of the:</text> <paragraph num="(1)"> <text>Date and place of an adopted individual's birth, a person shall provide to the Secretary:</text> <paragraph num="(a)"> <text>A birth certificate or other birth record for the adopted individual from the jurisdiction or country where the individual was born; and</text> </paragraph> <paragraph num="(b)"> <text>A certified translation of the foreign birth certificate or other birth record, if the foreign birth certificate or other birth record is not in English; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maryland residency of an adopting parent, an individual shall provide to the Secretary, subject to the restrictions set forth in §D of this regulation, one or more of the following documents relating to the parent:</text> <paragraph num="(a)"> <text>Most recent Maryland tax return;</text> </paragraph> <paragraph num="(b)"> <text>Most recent Maryland property tax bill;</text> </paragraph> <paragraph num="(c)"> <text>Local gas and electric bill that is no more than 4 months old;</text> </paragraph> <paragraph num="(d)"> <text>Valid Maryland driver's license; or</text> </paragraph> <paragraph num="(e)"> <text>Another record that corroborates the Maryland residency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary may:</text> <paragraph num="(1)"> <text>Require more than one of the documents listed in §C(2) of this regulation to be submitted to establish Maryland residency; and</text> </paragraph> <paragraph num="(2)"> <text>Refuse to issue a certificate of foreign birth if the Secretary finds the documentation submitted does not conclusively establish Maryland residency.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Secretary shall prepare a certificate of foreign birth with the:</text> <paragraph num="(1)"> <text>Name of the subject of the record being the name of the adopted individual as the individual's name appears or is set in the foreign adoption decree; and</text> </paragraph> <paragraph num="(2)"> <text>Names of the adopting parents recorded as the parents of the adopted individual.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In order for the Secretary to enter as the subject of a certificate of foreign birth a name different from the name of the adopted individual in the foreign adoption decree, a person shall provide to the Secretary an order from a court of competent jurisdiction that directs the Secretary to prepare the certificate with the different name for the adopted individual.</text> </paragraph> <paragraph num="G."> <text>The Secretary shall amend the subject's name on a certificate of foreign birth that has already been prepared and registered on receipt of:</text> <paragraph num="(1)"> <text>An order of a court of competent jurisdiction that changes the adopted individual's name; and</text> </paragraph> <paragraph num="(2)"> <text>A request from the adopted individual, the adopting parents, or a guardian or legal representative of the adopted individual that the amendment be made.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Secretary shall include on the Maryland certificate of foreign birth:</text> <paragraph num="(1)"> <text>The words “Certificate of Foreign Birth”;</text> </paragraph> <paragraph num="(2)"> <text>The adopted individual's actual country of birth; and</text> </paragraph> <paragraph num="(3)"> <text>A statement that the Maryland certificate of foreign birth is not evidence of United States citizenship for the individual for whom it is issued.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Birth Certificate of a Deceased Person."> <paragraph num="A."> <text>On presentation of an official death certificate, a birth certificate on a deceased individual may be issued to:</text> <paragraph num="(1)"> <text>A parent;</text> </paragraph> <paragraph num="(2)"> <text>A surviving spouse;</text> </paragraph> <paragraph num="(3)"> <text>A legal guardian; or</text> </paragraph> <paragraph num="(4)"> <text>An authorized representative of the deceased who presents an affidavit attesting to the purpose for obtaining the record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The birth record shall be stamped “DECEASED” and the date of death shall be recorded on it.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Verification of Data."> <paragraph num="A."> <text>Birth, Death, and Marriage Verification.</text> <paragraph num="(1)"> <text>Verification of the facts contained on the vital records in this section may be furnished by:</text> <paragraph num="(a)"> <text>The Secretary or, for births and deaths only, the local health officer of the county of the occurrence of the event, to any of the agencies cited in Regulation .08K of this chapter, in the conduct of their official duties; or</text> </paragraph> <paragraph num="(b)"> <text>The Secretary to a government official who requests the verification in order to carry out the duties or functions of the official's office as specified in Public Law 108-458 or Public Law 109-13.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The verifications in §A(1) of this regulation shall be on forms prescribed by the Secretary or on comparable forms which are furnished by the requesting agency or government official and are acceptable to the Secretary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Divorce and Annulment of Marriage Verifications.</text> <paragraph num="(1)"> <text>Verifications of the facts in this section shall be made available to persons who are authorized by either subject of the record, including those cited in Regulation .08K of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The verifications in §B(1) of this regulation shall contain the:</text> <paragraph num="(a)"> <text>Names of the parties involved;</text> </paragraph> <paragraph num="(b)"> <text>Type of divorce action or annulment;</text> </paragraph> <paragraph num="(c)"> <text>County in which the divorce or annulment action took place;</text> </paragraph> <paragraph num="(d)"> <text>Date of the decree; and</text> </paragraph> <paragraph num="(e)"> <text>Signature of the authorized representative of the Secretary.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Reports of Divorce and Annulment."> <paragraph num="A."> <text>The parties to a divorce or an annulment of marriage action, or their respective attorneys, shall provide the necessary information to the clerk of the appropriate court for the clerk to prepare and forward to the Secretary the required report of divorce or annulment of marriage.</text> </paragraph> <paragraph num="B."> <text>Divorce or annulment of marriage report records maintained by the Secretary are not official copies of the decrees, and certified copies of the decrees may not be issued by the Secretary.</text> </paragraph> <paragraph num="C."> <text>A copy of the decrees in §B of this regulation shall be obtained from the appropriate circuit court of the several counties of the State or Baltimore City, depending on where the divorce or annulment action took place.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Commemorative Birth Certificate."> <paragraph num="A."> <text>The commemorative birth certificate shall:</text> <paragraph num="(1)"> <text>Cost $50 per copy, except under certain circumstances to be determined by the Secretary of Health, and be available for issuance to the subject of the vital record or an authorized representative of the subject of the vital record, or both, or an order of a court of competent jurisdiction;</text> </paragraph> <paragraph num="(2)"> <text>Constitute a certified copy of the original birth record and have the same legal status and be treated with the same protections afforded the photocopied or electronically produced certified copy of the original birth certificate; and</text> </paragraph> <paragraph num="(3)"> <text>Be in a form consistent with the need to protect the integrity of vital records but suitable for display.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Funds collected for this certificate shall be paid into the Children's Trust Fund established under Health-General Article, §13-2207, Annotated Code of Maryland. Up to $25 of each $50 collected shall go to the Department for production costs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Death Certificate — Amendment."> <paragraph num="A."> <text>In order for the name of the deceased, the cause of death and medical certification, the manner of death, the date and time of death, and the place where the death occurred to be amended on a death certificate, the facts necessitating the amendment shall be certified to the Secretary by the physician, physician assistant, or nurse practitioner who filled out and signed the death certificate, or by the medical examiner.</text> </paragraph> <paragraph num="B."> <text>When a death certificate is filled out and signed by the medical examiner, only the medical examiner may certify to the Secretary the facts necessitating an amendment on the death certificate to the name of the deceased, the cause of death and medical certification, the manner of death, the date and time of death, and the place where the death occurred.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Certificate of Birth Resulting in Stillbirth."> <paragraph num="A."> <text>The Secretary shall prepare a Maryland certificate of birth resulting in stillbirth upon the request of the parent or parents of a stillborn child.</text> </paragraph> <paragraph num="B."> <text>In order for the Secretary to prepare a Maryland certificate of birth resulting in stillbirth:</text> <paragraph num="(1)"> <text>A fetal death shall be registered pursuant to Regulation .05A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The parent or parents requesting the certificate of birth resulting in stillbirth shall be named on the registered fetal death certificate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Information on Certificate.</text> <paragraph num="(1)"> <text>Except as provided in §C(2) of this regulation, the Secretary shall include on the certificate of birth resulting in stillbirth the following information as it appears on the fetal death certificate:</text> <paragraph num="(a)"> <text>Name of fetus;</text> </paragraph> <paragraph num="(b)"> <text>Date of delivery;</text> </paragraph> <paragraph num="(c)"> <text>Mother's maiden name;</text> </paragraph> <paragraph num="(d)"> <text>Mother's married name;</text> </paragraph> <paragraph num="(e)"> <text>Father's name; and</text> </paragraph> <paragraph num="(f)"> <text>Jurisdiction of delivery, specifying:</text> <paragraph num="(i)"> <text>A county; or</text> </paragraph> <paragraph num="(ii)"> <text>Baltimore City.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary shall include on a certificate of birth resulting in stillbirth the words, “Not a Certificate of Live Birth”.</text> </paragraph> <paragraph num="(3)"> <text>If the parent or parents do not wish to provide a name for the stillborn child, the Secretary may not include on the certificate of birth resulting in stillbirth any name for the stillborn child other than that appearing on the fetal death certificate.</text> </paragraph> <paragraph num="(4)"> <text>If the parent or parents want to add a name to appear on the certificate of birth resulting in stillbirth for the stillborn child that does not appear on the fetal death certificate or amend the name for the stillborn child, the parent or parents shall follow the procedure for additions and amendments to a name on a birth certificate, as set forth in Regulation .03B of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Births Outside an Institution."> <paragraph num="A."> <text>An attending clinician in charge of a birth outside an institution shall:</text> <paragraph num="(1)"> <text>Prepare the forms required by the Secretary to register the birth; and</text> </paragraph> <paragraph num="(2)"> <text>File the forms.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a birth occurs outside an institution and an attending clinician is not in charge of the birth, the local health officer or designee of the jurisdiction where the birth occurs shall:</text> <paragraph num="(1)"> <text>Verify the facts regarding the birth by obtaining the documentation required by §D of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Sign the birth record; and</text> </paragraph> <paragraph num="(3)"> <text>File the birth record with the Secretary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the facts regarding a birth cannot be verified by the local health officer of the jurisdiction where the birth occurs, in order for the Secretary to create a birth record, an individual listed in Health-General Article, §4-208(b), Annotated Code of Maryland, shall obtain an order from a court of competent jurisdiction that:</text> <paragraph num="(1)"> <text>Lists the facts about the birth; and</text> </paragraph> <paragraph num="(2)"> <text>Authorizes the Secretary to create the birth record according to the facts.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The following documentation shall be required to verify a birth outside an institution when an attending clinician is not in charge of the birth:</text> <paragraph num="(1)"> <text>A valid, unexpired, government-issued identification document for the child’s mother in the form of a:</text> <paragraph num="(a)"> <text>Driver’s license;</text> </paragraph> <paragraph num="(b)"> <text>State-issued photo identification card;</text> </paragraph> <paragraph num="(c)"> <text>Passport;</text> </paragraph> <paragraph num="(d)"> <text>Permanent resident card;</text> </paragraph> <paragraph num="(e)"> <text>Military identification card; or</text> </paragraph> <paragraph num="(f)"> <text>A signed statement the mother does not have any of the identification documents listed in §D(1)(a)—(e) of this regulation and two of the following documents that contain the applicant’s name and current address:</text> <paragraph num="(i)"> <text>Utility bill;</text> </paragraph> <paragraph num="(ii)"> <text>Car registration form;</text> </paragraph> <paragraph num="(iii)"> <text>Pay stub;</text> </paragraph> <paragraph num="(iv)"> <text>Bank statement;</text> </paragraph> <paragraph num="(v)"> <text>Income tax return;</text> </paragraph> <paragraph num="(vi)"> <text>Income tax W-2 form;</text> </paragraph> <paragraph num="(vii)"> <text>Lease or rental agreement; or</text> </paragraph> <paragraph num="(viii)"> <text>Letter from a government agency;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evidence of pregnancy in the form of:</text> <paragraph num="(a)"> <text>A prenatal or postnatal medical record that is consistent with the date of delivery and includes the:</text> <paragraph num="(i)"> <text>Mother’s name, date of birth, and date of health exam; and</text> </paragraph> <paragraph num="(ii)"> <text>Health care provider’s signature, printed name, signature date, and license number;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A statement from a physician or certified nurse midwife licensed in the United States, or a direct-entry midwife licensed in Maryland, who has first-hand knowledge of the pregnancy and is willing to attest to the fact of pregnancy;</text> </paragraph> <paragraph num="(c)"> <text>Preregistration with the local health department during pregnancy, including a face-to-face interview and physical examination;</text> </paragraph> <paragraph num="(d)"> <text>Documentation of a home visit by a public health nurse or other health care provider who has first-hand knowledge of the pregnancy; or</text> </paragraph> <paragraph num="(e)"> <text>Other evidence acceptable to the Secretary;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Evidence of live birth in the form of:</text> <paragraph num="(a)"> <text>A statement from a physician, certified nurse midwife, or other licensed health care provider who saw or examined the infant within the first 2 weeks of life;</text> </paragraph> <paragraph num="(b)"> <text>An observation of the infant during a home visit by a public health nurse or licensed health care provider during the first 2 weeks of life; or</text> </paragraph> <paragraph num="(c)"> <text>Other evidence acceptable to the Secretary; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Evidence of place of delivery in the State as follows:</text> <paragraph num="(a)"> <text>If the birth occurred in the mother’s place of residence, evidence of place of delivery shall be in the form of:</text> <paragraph num="(i)"> <text>A driver’s license or other State-issued identification document that includes the mother’s current Maryland address;</text> </paragraph> <paragraph num="(ii)"> <text>A rent receipt, mortgage statement, or deed that includes the mother’s name and Maryland address;</text> </paragraph> <paragraph num="(iii)"> <text>A recent pay stub that includes the mother’s name and Maryland address; or</text> </paragraph> <paragraph num="(iv)"> <text>Other evidence acceptable to the Secretary;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the birth occurred outside the mother’s place of residence and the mother is a resident of Maryland, evidence shall be in the form of:</text> <paragraph num="(i)"> <text>An affidavit from the tenant of the premises where the birth occurred stating that the mother was present on those premises at the time of the birth;</text> </paragraph> <paragraph num="(ii)"> <text>Evidence of the affiant’s residence similar to that required in §D(4)(a) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Evidence of the mother’s residence in the State similar to that required in §D(4)(a) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the mother is not a resident of Maryland, evidence shall consist of clear and convincing evidence acceptable to the Secretary.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Family Law Article, §§5-359, 5-3A-42, and 5-3B-29, and Title 5, Subtitle 4B;Health-General Article, §§4-201—4-227 and 13-2207; Annotated Code of MarylandCh.316, Acts of 2016; Public Law 108-458; Public Law 109-13</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1963</annotation> <annotation type="History" subtype="Administrative History">Amended effective January 1, 1965; May 16, 1966; January 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed effective November 30, 1987 (14:24 Md. R. 2555)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.03.01.07 cited in Attorney General Opinion No. 85-035 (December 31, 1985)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted effective November 30, 1987 (14:24 Md. R. 2555)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 17, 1992 (19:16 Md. R. 1474); January 2, 1994 (20:26 Md. R. 2027); January 24, 2000 (27:1 Md. R. 75); February 19, 2001 (28:3 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 8, 2007 (34:20 Md. R. 1736); June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 25, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, E amended effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective September 13, 1993 (20:18 Md. R. 1430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective January 2, 1994 (20:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 2, 1994 (20:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 19, 2001 (28:3 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 19, 2001 (28:3 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 24, 2000 (27:1 Md. R. 75)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 8, 2007 (34:20 Md. R. 1736)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective January 2, 1994 (20:26 Md. R. 2027); August 25, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective August 17, 1992 (19:16 Md. R. 1474); January 2, 1994 (20:26 Md. R. 2027); June 15, 2009 (36:12 Md. R. 837); October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective August 17, 1992 (19:16 Md. R. 1474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 19, 2001 (28:3 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective July 9, 1990 (17:13 Md. R. 1610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective January 17, 2005 (32:1 Md. R. 27)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective July 9, 1990 (17:13 Md. R. 1610); June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1 adopted effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective March 31, 2003 (30:6 Md. R. 420); June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted as an emergency provision effective January 20, 1989 (16:3 Md. R. 336); adopted permanently effective July 10, 1989 (16:13 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted as an emergency provision effective November 15, 1989 (16:26 Md. R. 2782); adopted permanently effective February 19, 1990 (17:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective February 18, 1991 (18:3 Md. R. 305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective November 23, 2006 (33:23 Md. R. 1794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective August 17, 1992 (19:16 Md. R. 1474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); adopted permanently effective December 11, 2003 (30:24 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 28, 2013 (40:21 Md. R. 1774); June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective January 18, 2016 (43:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08I, J amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective June 4, 2018 (45:11 Md. R. 578)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 15, 2013 (40:7 Md. R. 610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective October 28, 2013 (40:21 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 adopted effective June 4, 2018 (45:11 Md. R. 578)</annotation> </annotations> </chapter> <chapter num="02" heading="Release of Confidential Information in the Maternal and Child Health Bureau"> <regulation prefix="Regulation" num=".01" heading="Confidential Information."> <text>All information relating to personal facts and circumstances, such as names and addresses, medical examinations, and financial resources, obtained by the State or local staff administering the programs of the Maternal and Child Health Bureau shall be treated as confidential and may not be disclosed without the individual’s consent, except as may be necessary to provide services to individual mothers and children or as otherwise required by law. Information may be disclosed, however, in summary, statistical, or other form which does not identify individuals.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure of Confidential Information."> <text>All records and information shall be held confidential and may not be disclosed without the individual's consent, except as may be necessary to provide services to the individual mother or child or as otherwise required by law. This means that:</text> <paragraph num="A."> <text>Confidential information may be released without the patient's or parent's consent to agencies, institutions, or individuals who are authorized to provide maternal and child health services to the mother or child as a part of the program of the Maryland Department of Health.</text> </paragraph> <paragraph num="B."> <text>Confidential information may be released to other public agencies to the extent that they are authorized to provide services for the health and welfare of the mother or child for whom the patient, or the patient’s parent in the case of a minor, has requested services. In these circumstances, the information may be disclosed only if written assurances are given to the Maternal and Child Health Bureau that:</text> <paragraph num="(1)"> <text>The confidential character of the information will be preserved;</text> </paragraph> <paragraph num="(2)"> <text>The confidential information will be used only for the purpose for which it is disclosed;</text> </paragraph> <paragraph num="(3)"> <text>The purposes for the disclosure are reasonably related to the purposes of the program of the Maryland Department of Health and the functioning of the other agencies; and</text> </paragraph> <paragraph num="(4)"> <text>The standards of protection established by the other agencies to which the confidential information is released are of equal or greater stringency than those established by the Maryland Department of Health itself.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibility for Confidential Records and Information."> <text>The Director of the Maternal and Child Health Bureau, working under the Secretary of Health:</text> <paragraph num="A."> <text>Is responsible for carrying out this regulation and procedures;</text> </paragraph> <paragraph num="B."> <text>Shall initiate suitable office practices to assure the protection of confidential records; and</text> </paragraph> <paragraph num="C."> <text>Is responsible for informing staff employees who have access to confidential records and information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Permissible Disclosure."> <text>Information may be disclosed in summary, statistical, or other form, which does not make it possible to identify any particular individual.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 4-102, 4-301—4-309, and 15-125, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 20, 1950</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 20, 1993 (20:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 22, 2007 (34:21 Md. R. 1914); March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 22, 2007 (34:21 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 22, 2007 (34:21 Md. R. 1914); March 14, 2016 (43:5 Md. R. 385)</annotation> </annotations> </chapter> </subtitle> <subtitle num="04" heading="Fiscal"> <chapter num="01" heading="Local Health Services Funding"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the provision of funding for local health services designated in Health-General Article, §2-304, Annotated Code of Maryland, and, at the discretion of the Secretary, any other State or federal funds that support these services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Annual formula adjustment” means the amount calculated after applying the percentage change as determined by Health-General Article, §2-302(b)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Federal non-matching funds” means federal funds made available annually by the State to a subdivision for local health services that do not require local matching funds.</text> </paragraph> <paragraph num="(4)"> <text>“Local health services” means the services specified in Health-General Article, §2-304, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Local matching funds” means the annual funding made available by a subdivision for local health services to qualify for State matching funds, plus any excess amount.</text> </paragraph> <paragraph num="(6)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(7)"> <text>“State funds” means State matching funds plus federal nonmatching funds.</text> </paragraph> <paragraph num="(8)"> <text>“State matching funds” means the general funds made available annually to a subdivision by the State for local health services that require local matching funds.</text> </paragraph> <paragraph num="(9)"> <text>“Subdivision” means a county of this State and Baltimore City.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Distribution of State Matching Funds."> <paragraph num="A."> <text>For fiscal year 2013 and each subsequent fiscal year, each subdivision shall receive, at a minimum, the amount of State matching funds distributed in fiscal year 2012 for local health services.</text> </paragraph> <paragraph num="B."> <text>The annual formula adjustment and any other adjustments for local health services shall be allocated to each subdivision based on each subdivision's percentage share of State funds distributed in the previous fiscal year, and to address a substantial change in community health need, if any, as determined in the discretion of the Secretary after consultation with local health officers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirement for Local Matching Funds."> <paragraph num="A."> <text>As to appropriations referenced in Health-General Article, §2-302, Annotated Code of Maryland, local matching funds shall be required as a condition of any distribution to a subdivision.</text> </paragraph> <paragraph num="B."> <text>The local match percentage for each subdivision shall equal the percentage required for each subdivision for fiscal year 1996.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Submission of Local Health Department Budget for Local Health Services."> <paragraph num="A."> <text>An operating budget to implement each local health department's projects for the next fiscal year, funded partially or wholly from funds provided through local health services, shall be prepared in sufficient detail and submitted to the Department for the Secretary to determine the acceptability of the budget.</text> </paragraph> <paragraph num="B."> <text>The format, content, and submission date of the budget shall be as set forth in the annual local health department budget instructions available on the Department's website or as otherwise determined by the Secretary.</text> </paragraph> <paragraph num="C."> <text>Each position shall be accounted for in only one project; however, funding for a position may be split among several projects.</text> </paragraph> <paragraph num="D."> <text>An agreement form signed by the county executive authority and the health officer of the subdivision shall be transmitted to the Department by a date established by the Secretary for the upcoming State fiscal year. The agreement shall include, but is not limited to, the following:</text> <paragraph num="(1)"> <text>A statement showing the amount of the local matching funds, along with any qualifications which cover that funding;</text> </paragraph> <paragraph num="(2)"> <text>A statement indicating whether the subdivision elects to be the paying agent for items other than salaries, or requests that the Department act in that capacity, and, in the event of such a request, the names of the persons upon whose authority commitments and expenditures are authorized; and</text> </paragraph> <paragraph num="(3)"> <text>A statement indicating whether the subdivision wishes to audit those records of the Department pertaining to disbursements made on behalf of the subdivision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the subdivision elects to make an audit as described in §D(3) of this regulation, the audit shall be done within 3 years after the close of the fiscal year that is the subject of the audit.</text> </paragraph> <paragraph num="F."> <text>On approval by the Secretary, the budget containing State and federal funds and the required local matching funds shall be used as the basis of operation by the health officer for State-supported services.</text> </paragraph> <paragraph num="G."> <text>Any substantive change in local health projects during the fiscal year is subject to Departmental review and approval, as set forth in the annual local health department budget instructions.</text> </paragraph> <paragraph num="H."> <text>Cash Transactions.</text> <paragraph num="(1)"> <text>The Department only assumes responsibility in any fiscal year for paying from its funds the State matching funds certified by the Secretary of Health in the agreement for local health services.</text> </paragraph> <paragraph num="(2)"> <text>If a subdivision elects the Department to be its disbursing agent, and the subdivision fails to deposit sufficient funds with the Department to satisfy the subdivision's share of local health services expenditures, the Department may not disburse funds for the subdivision until sufficient funds are deposited by the subdivision to meet the subdivision's financial obligations.</text> </paragraph> <paragraph num="(3)"> <text>If a subdivision elects the Department to be its disbursing agent, the Secretary may charge for the cost of the disbursement-related administrative services rendered by the Division of General Accounting.</text> </paragraph> <paragraph num="(4)"> <text>If the subdivision elects to be the disbursing agent:</text> <paragraph num="(a)"> <text>Disbursements shall be reported monthly to the Division of General Accounting of the Department, in the form and under the conditions as the Department may specify from time to time, in order that these disbursements may be entered on the central accounting records;</text> </paragraph> <paragraph num="(b)"> <text>Funds owed a subdivision shall be paid to the subdivision within 30 days following the end of each quarter, except that funds owed at fiscal year end shall be paid to the subdivision within 30 days following the completion of the annual cost settlement process; and</text> </paragraph> <paragraph num="(c)"> <text>Funds owed the State by a subdivision at fiscal year end shall be paid to the State within 30 days following the completion of the annual cost settlement process.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Procedures and Conditions."> <paragraph num="A."> <text>Purpose of Expenditure. State funds and local matching funds may only be expended if the activity to be funded is:</text> <paragraph num="(1)"> <text>The responsibility of the local health officer, the Secretary, or the Secretary of the Environment, as established by the general public laws of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Delegated to the local health officer by the Secretary or the Secretary of the Environment; and</text> </paragraph> <paragraph num="(3)"> <text>With respect to §A(1) and (2) of this regulation, not budgeted for separately in the State budget.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Procurement. If authorized by the principal executive or legislative authority of the subdivision's government in accordance with local ordinance, a local health department may use either the State procurement system or the procurement system of the subdivision in which the local health department is located. In the absence of such authorization, a local health department shall use the State procurement system in accordance with State Finance and Procurement Article, Annotated Code of Maryland, and COMAR Title 21.</text> </paragraph> <paragraph num="C."> <text>Expense Accounts. Amounts spent to reimburse personnel for travel expenses in accordance with COMAR 23.02.01 are eligible for State matching funds.</text> </paragraph> <paragraph num="D."> <text>Employee Fringe Benefits. The employer's payments for Social Security, retirement systems, health insurance, and unemployment insurance are eligible for State matching funds.</text> </paragraph> <paragraph num="E."> <text>Revenues. Amounts collected in accordance with COMAR 10.02.01 as the result of services rendered as part of local health services shall be treated as a reduction of expenditures for the corresponding project. Amounts collected by subdivisions shall be reported monthly to the Department.</text> </paragraph> <paragraph num="F."> <text>Interest. A subdivision shall:</text> <paragraph num="(1)"> <text>Deposit the collections and funds allocated to support local health services in a federally insured interest-bearing account when these funds are not required to meet current local health services expenses; and</text> </paragraph> <paragraph num="(2)"> <text>Treat interest income from the local health service revenues which generated the interest as a reduction of expenditures for the local health service which generated the interest.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Prohibited Expenditures.</text> <paragraph num="(1)"> <text>State matching funds may not be used to support the following categories of expenditures:</text> <paragraph num="(a)"> <text>Hospitalization of clients;</text> </paragraph> <paragraph num="(b)"> <text>Equipment and appliances for individuals;</text> </paragraph> <paragraph num="(c)"> <text>Salary supplements;</text> </paragraph> <paragraph num="(d)"> <text>Utilities;</text> </paragraph> <paragraph num="(e)"> <text>Janitorial expenses;</text> </paragraph> <paragraph num="(f)"> <text>Landscaping; or</text> </paragraph> <paragraph num="(g)"> <text>Other items the Secretary may specify.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>State matching funds may not participate in the capital costs of or improvements to the physical facilities in which local health department operations are conducted. This regulation applies regardless of the manner in which this cost is defrayed including but not limited to rental, lease, and direct payment of contract for construction or installation.</text> </paragraph> <paragraph num="(3)"> <text>State matching funds may not be used to defray the cost of debt service if the construction or improvement is financed by the creation of a long-term debt.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Insurance, Repair, and Maintenance of Physical Assets. The cost of insuring, repairing, or maintaining physical assets, the provision of which under this chapter is the responsibility of the subdivision, is not eligible for State matching funds.</text> </paragraph> <paragraph num="I."> <text>Reimbursement for Injuries. Amounts paid as compensation for injury incurred in the line of duty, and injury other than as a result of malpractice occurring on the premises of a facility of a local health department, as well as the cost of insuring for this liability, are eligible for State matching funds.</text> </paragraph> <paragraph num="J."> <text>Audits.</text> <paragraph num="(1)"> <text>All Department records of disbursements relating to local health department activities are available for audit by representatives of the county, if they so elect, as provided in Regulation .05D(3) and E of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>All records of disbursements and revenues of the counties relating to local health department activities shall be available for audit by representatives of the Department for at least 5 years following the close of each fiscal year or until audited by the State, whichever comes first.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(a), 2-105, 2-301—2-305; State Finance and Procurement Article, §12-109; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1956</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 20, 1989 (16:5 Md. R. 628)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 2, 1994 (20:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective May 22, 1995 (22:10 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.06 adopted effective February 26, 2007 (34:4 Md. R. 400)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 21, 2008 (35:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 14, 2011 (38:23 Md. R. 1421)</annotation> </annotations> </chapter> <chapter num="02" heading="Establishment and Payment of In-Patient Charges by Recipients of Services and Other Chargeable Persons for the Patient's Care"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>It is the policy of the Maryland Department of Health to determine the ability of recipients of services, responsible relatives, and other chargeable persons to pay for in-patient or in-residence services to individuals in State-operated facilities. These regulations shall govern the assessment of these charges unless specific charges are established by statutory enactment.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>“Adjusted gross monthly income” means gross monthly income less allowable deductions as set forth in Regulation .04C(5), of this chapter.</text> </paragraph> <paragraph num="B."> <text>“Assets” means all accumulated personal wealth over which a person has the authority or power to liquidate his interest, including but not limited to cash savings, savings accounts, certificates of deposit, money market certificates, checking accounts, stocks, bonds, real property, personal property, mortgages, and mutual funds.</text> </paragraph> <paragraph num="B-1."> <text>“Chargeable person” means:</text> <paragraph num="(1)"> <text>Any responsible relative; and</text> </paragraph> <paragraph num="(2)"> <text>Except for a recipient of services, any other person who is legally responsible in an individual or representative capacity for the care of an individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>“Collectively” means pertaining to any combination of one or more responsible relatives.</text> </paragraph> <paragraph num="D."> <text>“College expenses” means tuition cost for undergraduate studies.</text> </paragraph> <paragraph num="E."> <text>“Department” means Maryland Department of Health.</text> </paragraph> <paragraph num="F."> <text>“Dependent” means any person who qualifies as a dependent under the dependency test of the Internal Revenue Service.</text> </paragraph> <paragraph num="G."> <text>“Gross monthly income” means total annual gross income divided by 12.</text> </paragraph> <paragraph num="H."> <text>“Income” means a recurrent money benefit from any source.</text> </paragraph> <paragraph num="I."> <text>“Individually” means pertaining to one sponsor.</text> </paragraph> <paragraph num="J."> <text>“In-patient” means a person admitted to a State-operated facility.</text> </paragraph> <paragraph num="K."> <text>“In-patient day.” The number of days of service received by a patient for in-patient services is always in units of full days; a day begins at midnight and ends 24 hours later. The midnight method is to be used for billing days of care of patients. A part of a day, including the day of admission, counts as a full day, however, the day of discharge, the day of death, or a day on which a patient begins a leave of absence is not counted as a day. If admission and discharge or admission and death occur the same day, the day is considered a day of admission and counts as one in-patient day.</text> </paragraph> <paragraph num="L."> <text>“Monthly rate” means the charge as developed under Regulation .04C(9)(a) of this chapter.</text> </paragraph> <paragraph num="M."> <text>“Patient” means in-patient.</text> </paragraph> <paragraph num="N."> <text>“Payroll taxes” means Social Security, federal, State, and local income taxes.</text> </paragraph> <paragraph num="O."> <text>“Rate” means monthly rate.</text> </paragraph> <paragraph num="O-1."> <text>“Recipient of services” means an individual who receives care, maintenance, treatment, and support in a facility or program that is operated or funded wholly or partly by the Department.</text> </paragraph> <paragraph num="P."> <text>“Responsible relative” means the:</text> <paragraph num="(1)"> <text>Spouse of a recipient of services;</text> </paragraph> <paragraph num="(2)"> <text>Parents of a recipient of services who is a minor; and</text> </paragraph> <paragraph num="(3)"> <text>Children of a recipient of services.</text> </paragraph> </paragraph> <paragraph num="Q."> <text>“Secretary” means Secretary of Health.</text> </paragraph> <paragraph num="R."> <text>“Sponsor” means responsible relative.</text> </paragraph> <paragraph num="S."> <text>“State-operated facility” means those hospitals and centers as set forth in Health-General Article, §§7-305, 10-406, and 19-502, Annotated Code of Maryland.</text> </paragraph> <paragraph num="T."> <text>“Total lifetime hospitalization” means the sum total of all periods of inpatient hospitalization for a recipient of services in any State hospital or facility whether these periods are intermittent or continuous.</text> </paragraph> <paragraph num="U."> <text>“Treatment” means any process by which professional care or attention is given to a patient in a State-operated facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Determination of the Ability of a Recipient of Services to Pay."> <paragraph num="A."> <text>A recipient of services' primary liability-to-pay in-patient charges established in accordance with COMAR 10.02.01.04 shall be determined by conducting a financial investigation of the individual's income, assets, and expenses.</text> </paragraph> <paragraph num="B."> <text>Notwithstanding any other provision of law to the contrary, the Department or its designated financial agent may obtain and use financial information and, if and when necessary, a summary of medical and psychological diagnoses regarding a recipient of services. If the obtaining and use of this information is connected to the Department's billing and collection functions under Health-General Article, Title 16, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>The Department shall obtain a release from the recipient of services or a chargeable person to secure information from a financial institution;</text> </paragraph> <paragraph num="(2)"> <text>The Department shall request either copies of the recipient of services' most recently filed federal and state income tax returns or an affidavit that the recipient of services did not file tax returns for the previous tax year;</text> </paragraph> <paragraph num="(3)"> <text>The failure of the recipient of services to provide the Department with the required documents of financial status, including the most recently filed federal and state income tax returns, may result in the Department charging and the recipient of services being liable for the full per-capita daily charge for services as set forth in COMAR 10.02.01.04; and</text> </paragraph> <paragraph num="(4)"> <text>Except as provided in §C of this regulation, all information obtained by the Department or its designated agent shall be treated as confidential.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the financial information is connected to the treatment or care of a recipient of services, the Department or its designated financial agent may disclose the financial information to a designated clinical representative of a facility.</text> </paragraph> <paragraph num="D."> <text>The Department may set the amount of payments retroactively:</text> <paragraph num="(1)"> <text>For a period of not more than 6 months from the date when the Department sets the amount of payments; and</text> </paragraph> <paragraph num="(2)"> <text>After inquiry by the Department, for a greater period, if the recipient of services, the responsible relatives of the recipient, or any other person, agency, or organization having a summary of financial information or medical or psychological diagnoses about the recipient of services has failed or refused to give that information to the Department when the obtaining and use of this information is connected to the Department's billing and collection functions under this subtitle.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall make a claim against all available income or assets, or both, of a recipient of services.</text> </paragraph> <paragraph num="F."> <text>Health insurance coverage and other third party reimbursements correctly paid, or to be paid, for services provided by the Department shall be considered available for billing purposes.</text> </paragraph> <paragraph num="G."> <text>For purposes of determining a recipient of services' financial capacity to contribute towards the cost of his or her care, the Department shall consider all of the recipient of services' assets and income to be available for billing purposes subject to certain billing reductions. In recognition of an individual's ongoing financial needs, the Department shall consider a reduction in a recipient of services' billing by permitting the income allowances, asset exemptions, and allowable expenses indicated below. A billing reduction may not be permitted unless and until the recipient of services submits appropriate written documentation demonstrating his or her entitlement to the billing reduction. Permitted billing reductions are as follows:</text> <paragraph num="(1)"> <text>Exempted Assets. The following assets shall be excluded from the Department's ability to pay determinations:</text> <paragraph num="(a)"> <text>A primary residence, occupied by spouse or dependents.</text> </paragraph> <paragraph num="(b)"> <text>A primary residence unoccupied by a spouse or dependents. The assessed value of a recipient of services' primary residence may not be considered for the purpose of establishing charges incurred by the recipient of services during the first 6 months of the individual's hospitalization. An additional 6 months exemption may be allowed if the recipient of services provides written verification from the Department clinician who is primarily responsible for the individual's care which indicates that there is a reasonable clinical likelihood that the individual will be discharged from the facility not later than 12 months following his or her admission to the facility.</text> </paragraph> <paragraph num="(c)"> <text>Household furnishings.</text> </paragraph> <paragraph num="(d)"> <text>One motor vehicle plus other motor vehicles necessary for employment, education, medical care, or maintenance of family life.</text> </paragraph> <paragraph num="(e)"> <text>Liquid assets including but not limited to cash, certificates of deposit, savings and checking accounts, stocks and bonds whose total value does not exceed $2,500.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Income allowances. The following sources of income shall be excluded from the Department's ability to pay determinations:</text> <paragraph num="(a)"> <text>Therapeutic work activity income earned in a Department sponsored or approved program which may not exceed $100 per month;</text> </paragraph> <paragraph num="(b)"> <text>If the recipient of services is not involved in a therapeutic work activity program, a monthly personal income allowance of $40.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Allowable Expenses. The following documented expenses shall be deducted from the countable gross income in determining a person's ability-to-pay:</text> <paragraph num="(a)"> <text>Reasonable transportation expenses incurred by a recipient of services' relatives and designated visitors during the course of visits to a facility. Mileage allowances shall be calculated in accordance with the prevailing travel allowances permitted for State employees.</text> </paragraph> <paragraph num="(b)"> <text>Health insurance premiums.</text> </paragraph> <paragraph num="(c)"> <text>Life insurance premiums for policies which have a maximum face value which does not exceed $2,500.</text> </paragraph> <paragraph num="(d)"> <text>Reasonable allowances shall be made for necessary and appropriate purchases of clothing and other personal items which may be used by the recipient of services while in a residence or during the course of a clinically sponsored activity. Clinicians responsible for the recipient of services care and treatment shall be consulted to determine the appropriateness of the requested item.</text> </paragraph> <paragraph num="(e)"> <text>Reasonable income allowances reflecting the actual expenses incurred by a recipient of services in maintaining his or her primary residence or apartment provided that when the recipient of services:</text> <paragraph num="(i)"> <text>Is unmarried and has no dependents, the income allowance shall be permitted only for that period of time that the residence is afforded exempt status pursuant to Regulation .03G(1)(b); and</text> </paragraph> <paragraph num="(ii)"> <text>Income constitutes the primary source of financial support for a spouse or other individual claimed as dependents on that individual's federal income tax return, an additional monthly income allowance shall be permitted in an amount equal to the appropriate base monthly deduction as set forth in Regulation .04C(8).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Monthly Rate. If a combined income is available, the monthly rate charged to the recipient of services and spouse will be computed according to Regulation .04, of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Determination of the Ability of a Responsible Relative to Pay."> <paragraph num="A."> <text>Investigation of Financial Condition.</text> <paragraph num="(1)"> <text>A responsible relative's ability to pay will be determined by an investigation of the financial condition of the person or persons to be held liable for payment for the in-patient treatment rendered at a State-operated facility. The assets, income, and cost of living of responsible relatives will be the subject of the investigation.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall request either copies of the responsible relative's most recently filed federal and state income tax returns or an affidavit that the responsible relative did not file tax returns for the previous tax year.</text> </paragraph> <paragraph num="(3)"> <text>The failure of the responsible relative to provide the Department with the required documents of financial status, including the most recently filed federal and state income tax returns, may result in the Department charging and the responsible relative being liable for the full per-capita daily charge for services as set forth in COMAR 10.02.01.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A maximum monthly charge for which responsible relatives may be held liable, within the scope of these regulations, will be developed by the Department in the following manner:</text> <paragraph num="(1)"> <text>A charge will be developed by multiplying the daily charge set by the Secretary of the Department times 365 and dividing that product by 12.</text> </paragraph> <paragraph num="(2)"> <text>A responsible relative's ability to pay will be measured against the maximum monthly charge.</text> <paragraph num="(a)"> <text>Amounts assessed individually and collectively may not exceed the maximum monthly charge.</text> </paragraph> <paragraph num="(b)"> <text>When a rate is prorated because the total ability to pay of all responsible relatives exceeds the total of the responsible relatives' liability, charges to each responsible relative will be prorated by applying each responsible relatives' ability to pay as a percentage of all responsible relatives' ability to pay.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Procedure to be Followed for Computation of Monthly Rate.</text> <paragraph num="(1)"> <text>The rate for which a person may be held liable will be determined from that person's adjusted gross monthly income as determined from the financial investigation required by §A, above.</text> </paragraph> <paragraph num="(2)"> <text>The adjusted gross monthly income will be determined by deducting from the gross monthly income all payroll taxes as computed on tax deduction charts developed by the Department and all applicable special or unusual expenses as set forth in these regulations.</text> </paragraph> <paragraph num="(3)"> <text>Self-employment tax paid will be considered in lieu of Social Security tax.</text> </paragraph> <paragraph num="(4)"> <text>Payment into the Federal Retirement Fund will be considered in lieu of Social Security.</text> </paragraph> <paragraph num="(5)"> <text>Special or unusual expenses which may be allowed are:</text> <paragraph num="(a)"> <text>Reasonable child care expenses incurred by the working sponsor;</text> </paragraph> <paragraph num="(b)"> <text>Child support or alimony payments if payments are made to a person who does not qualify as a dependent;</text> </paragraph> <paragraph num="(c)"> <text>College expenses for dependents not to exceed the amount charged for tuition by the University of Maryland at College Park for undergraduate programs;</text> </paragraph> <paragraph num="(d)"> <text>Union dues;</text> </paragraph> <paragraph num="(e)"> <text>Mandatory contributions to retirement plans; and</text> </paragraph> <paragraph num="(f)"> <text>Expenses for special work clothes or special work equipment.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Rental Income. One half of gross rental income will be considered as net rental income and will be included in gross monthly income. This may be modified if justifiable reasons are substantiated.</text> </paragraph> <paragraph num="(7)"> <text>Medical Expenses.</text> <paragraph num="(a)"> <text>Paid medical expenses in excess of those used in the cost of living tables in §C(8) may be allowed as an additional deduction.</text> </paragraph> <paragraph num="(b)"> <text>Medical expenses which are covered by medical insurance will not be allowed.</text> </paragraph> <paragraph num="(c)"> <text>Medical insurance premiums will be allowed as medical expenses.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Base Monthly Deduction.</text> <paragraph num="(a)"> <text>The Department will develop a base monthly deduction, using the figures established by the Department of Commerce, for the average monthly consumption of a family of four of moderate means in an urban area. The Department will, using 1991 as the base year, adjust annually the base monthly deduction by the percentage by which benefits under Title II of the Social Security Act (42 U.S.C. 401 through 433) are increased by the federal government to reflect changes in the cost of living, as that percentage change is reported in the Federal Register in accordance with 42 U.S.C. 415(a)(1)(D).</text> </paragraph> <paragraph num="(b)"> <text>The base monthly deduction shall be retained in the Office of the Division of Reimbursements and in the Financial Agents' Office located at the Department's in-patient facilities.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Monthly Rate.</text> <paragraph num="(a)"> <text>The monthly rate will be determined by subtracting the base monthly deduction from the adjusted gross monthly income. The excess of the adjusted gross monthly income over the base monthly deduction will be the rate of charge for which the responsible relative will be held liable.</text> </paragraph> <paragraph num="(b)"> <text>If the base monthly deduction is equal to or greater than the adjusted gross monthly income, the rate will be zero.</text> </paragraph> <paragraph num="(c)"> <text>Rates will not be set if calculation of a rate results in an amount due of less than $5 per month.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Total Lifetime Hospitalization.</text> <paragraph num="(a)"> <text>If a chargeable person has paid for 24 months total lifetime hospitalization of a recipient of services, the liability of that person for the recipient of services after that period may not exceed 15 percent of the charges for services set forth in this section.</text> </paragraph> <paragraph num="(b)"> <text>The sum of any proceeds of applicable insurance, group health plan, or prepaid medical care that the insurer or plan pays because of liability for the payment of or repayment for the cost of care provided to the recipient of services does not count as payments paid by a chargeable person for the purpose of determining a recipient of services, total lifetime hospitalization.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§16-201—16-407, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 1, 1976 (3:18 Md. R. 981)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 amended effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 27, 1988 (15:13 Md. R. 1553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02S amended effective June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 27, 1988 (15:13 Md. R. 1553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 15, 2001 (28:20 Md. R. 1782)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 15, 2001 (28:20 Md. R. 1782)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended as an emergency provision effective December 2, 1983 (10:26 Md. R. 2336); emergency status expired May 10, 1984 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended as an emergency provision effective June 6, 1984 (11:13 Md. R. 1169); adopted permanently effective October 8, 1984 (11:20 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective June 3, 1985 (12:11 Md. R. 1048); March 23, 1987 (14:6 Md. R. 715); June 27, 1988 (15:13 Md. R. 1553); June 26, 1989 (16:12 Md. R. 1335); September 2, 1991 (18:17 Md. R. 1918); August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed effective May 5, 1986 (13:9 Md. R. 1028)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.04.02.03 cited in State of Maryland Central Collection Unit v. Stewart, 292 Md. 255, 438 A.2d 1311 (1981)</annotation> </annotations> </chapter> <chapter num="03" heading="Standards for Audits of Grants and Contracts with Providers and Local Health Departments"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to prescribe standards, policies, and procedures for the auditing of grants and contracts of the Maryland Department of Health with vendors, providers of service, and local health departments.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter shall apply to all contracts and grants made by the Maryland Department of Health with private vendors, grantees, and local health departments for which an audit is provided as described in State Finance and Procurement Article, §7-404, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The audit shall determine whether funds were spent in accordance with the contract or grant agreement.</text> </paragraph> <paragraph num="C."> <text>The auditor shall review expenditures and revenues to determine if they are consistent with the approved budget and supported by documentation in accordance with the contract or grant agreement and generally accepted accounting principles.</text> </paragraph> <paragraph num="D."> <text>The audit shall establish amounts due to or from the State by comparison of budgeted, reported, and audited expenditures net of revenues and funded amounts.</text> </paragraph> <paragraph num="E."> <text>The audit findings shall be the basis for making a final settlement of the grant or contract.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Contract” means a formal agreement between the Maryland Department of Health and a provider of services to conduct a program or perform specified services for a consideration.</text> </paragraph> <paragraph num="(2)"> <text>“Expenditures” means disbursement of funds to pay vendors and employees for goods or services provided.</text> </paragraph> <paragraph num="(3)"> <text>“Grant” means an award of financial assistance to an eligible recipient under programs that provide for this assistance based on review and approval of an application setting forth a proposed activity or program.</text> </paragraph> <paragraph num="(4)"> <text>“Grantee” means that institution, public or private agency, corporation, organization, or other legally accountable entity that receives a grant and assumes legal and financial responsibility and accountability both for the awarded funds and for the performance of the grant supported activity.</text> </paragraph> <paragraph num="(5)"> <text>“Revenues” mean monies generated by the program, such as client fees, payments by third parties, contributions and interest earned on deposited grant funds.</text> </paragraph> <paragraph num="(6)"> <text>“Subgrantee” means one of two or more entities whose activities, individually and collectively, are intended to fulfill the purpose of the grant program pursuant to an agreement between the subgrantee and the grantee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Agency Responsibility."> <paragraph num="A."> <text>The Secretary of Health shall provide for a periodic examination of the accounts and records of grantees and local health departments receiving funds under contracts and grants with the Department. In addition, periodic audits shall be conducted of the accounts and records of vendors providing purchase of care services for children, juveniles, and adults in non-governmental facilities. The purpose of the audit is to determine if the expenses incurred for which reimbursement was received were in accordance with allowable cost guidelines of the grant award and contractual agreement.</text> </paragraph> <paragraph num="B."> <text>The Audit Division of the Maryland Department of Health shall be responsible for auditing the accounts and records of all grantees, local health departments, and vendors providing purchase of care services under grants and contracts with the Department, except for those grants and contracts with local governments for which audits have been conducted in accordance with the Single Audit Act of 1984. If these audits are not conducted, or are conducted but do not satisfy the information requirements of the Department, the Audit Division shall be responsible for such further auditing as it deems necessary under the circumstances.</text> </paragraph> <paragraph num="C."> <text>The audits shall be conducted in accordance with the terms of the grant or contract, or both, and in accordance with allowable cost guidelines of the Maryland Department of Health and its various administrations.</text> </paragraph> <paragraph num="D."> <text>The Audit Division of the Maryland Department of Health may audit a subgrantee, notwithstanding the responsibility of the primary grantee when it is in the interest of the State to do so. The Department, when it elects to audit a subgrantee, shall inform the primary grantee, in writing, that the primary grantee is absolved of the responsibility stated in Regulation .05C, of this chapter.</text> </paragraph> <paragraph num="E."> <text>The Audit Division shall conduct an exit conference upon the conclusion of the audit. Before the exit conference the grantee, vendor, or local health department shall be given a draft audit report containing all findings, exceptions, and recommendations of the auditors. In addition, the draft report shall provide detailed information pertaining to amounts due to or from the State resulting from the audit.</text> </paragraph> <paragraph num="F."> <text>The Audit Division, after consideration and evaluation of additional information and evidence presented subsequent to the promulgation of the draft audit report, shall issue a final audit report.</text> </paragraph> <paragraph num="G."> <text>The final audit report shall be distributed to the:</text> <paragraph num="(1)"> <text>Grantee, provider, vendor, or local health department;</text> </paragraph> <paragraph num="(2)"> <text>Division of Program Cost and Analysis of the Maryland Department of Health, as applicable;</text> </paragraph> <paragraph num="(3)"> <text>Director of the appropriate program administration of the Maryland Department of Health.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Audit Division in the final audit report shall:</text> <paragraph num="(1)"> <text>Address and explain each exception identified by the auditor;</text> </paragraph> <paragraph num="(2)"> <text>Make recommendations for correction of each exception cited in the report;</text> </paragraph> <paragraph num="(3)"> <text>Specify amounts due and to whom;</text> </paragraph> <paragraph num="(4)"> <text>Comment on any other issue warranting attention.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The audits shall be performed at the intervals and in the manner approved and determined by the Secretary of Health or Director of the appropriate program administration, after consultation with the Chief of the Audit Division.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Grantee Responsibility."> <paragraph num="A."> <text>The grantee, provider, and local health departments shall provide full disclosure of all accounting, financial, and other records as needed, to the Audit Division during regular business hours of the audited organization.</text> </paragraph> <paragraph num="B."> <text>The grantee, provider, and local health department shall retain all accounts and records of the grant or contract for a period of 5 years following the close of each fiscal year for audit by the Department.</text> </paragraph> <paragraph num="C."> <text>Each primary grantee shall be responsible for auditing subgrantees in accordance with the chapter.</text> </paragraph> <paragraph num="D."> <text>Each grantee shall maintain detailed accounting records as to receipts and expenditures of grant funds pertaining to the direct administration of the program. Each subgrantee is accountable to the primary grantee, who is responsible directly to the Division of Program Cost and Analysis of the Maryland Department of Health.</text> </paragraph> <paragraph num="E."> <text>Revenues collected as a result of sale of goods and services rendered by persons or facilities receiving grant funds shall be credited to the grant program, and be applied as a reduction of the gross expenditures of the program. These revenues shall include fee collections, third-party payments, and proceeds from sales of goods obtained or manufactured with labor and materials paid for with grant funds. Revenues shall also include interest earned on deposited grant funds and contributions, with the exception of those contributions which are undesignated.</text> </paragraph> <paragraph num="F."> <text>The grantee, provider, or local health department shall have the right to present additional information and evidence to support its position relative to the audit findings. This information and evidence may be presented at the exit conference or at any time before the issuance of the final audit report.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">State Finance and Procurement Article, §7-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 12, 1985 (12:16 Md. R. 1605)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective March 6, 1989 (16:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective March 6, 1989 (16:4 Md. R. 497)</annotation> </annotations> </chapter> <chapter num="04" heading="Human Services Agreements Manual"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Agreement” means a legal document setting forth the rights and responsibilities of the Department and the vendor.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Human Services” means shelter, support and health or health-related care, including corollary operations necessary to the delivery of that care.</text> </paragraph> <paragraph num="(4)"> <text>“Vendor” means any organization, including a local health department, which delivers human services under a funding arrangement governed by an agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Manual."> <paragraph num="A."> <text>The Department may enter into an agreement with a vendor to provide human services.</text> </paragraph> <paragraph num="B."> <text>The agreement shall specify that the Department and the vendor comply with requirements and procedures set forth in the “Human Services Agreements Manual”, which is incorporated by reference.</text> </paragraph> <paragraph num="C."> <text>The Department shall supply each vendor with a copy of the “Human Services Agreements Manual”.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b); State Government Article, §10-110; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 5, 1988 (15:18 Md. R. 2147)</annotation> </annotations> </chapter> <chapter num="05" heading="Community Residential Services" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: March 14, 1994 (21:5 Md. R. 403)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed effective March 31, 2014 (41:6 Md. R. 378)</annotation> </annotations> </chapter> <chapter num="06" heading="Late Payments" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective July 1, 1996 (23:14) Md. R. 1006);adopted permanently effective October 7, 1996 (23:20 Md. R. 1422)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective November 3, 1997 (24:22 Md. R. 1551)</annotation> </annotations> </chapter> </subtitle> <subtitle num="05" heading="Freestanding Ambulatory Care Facilities"> <chapter num="01" heading="General Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to all freestanding ambulatory care facilities.</text> </paragraph> <paragraph num="B."> <text>An applicant or licensee shall also comply with the regulations of one of the following chapters as appropriate:</text> <paragraph num="(1)"> <text>COMAR 10.05.02;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.05.03;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.05.04; or</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.05.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Facility” means a freestanding ambulatory care facility as defined in §B(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>“FDA” means the Food and Drug Administration of the U.S. Department of Health and Human Services.</text> </paragraph> <paragraph num="(4)"> <text>“Freestanding ambulatory care facility” means a:</text> <paragraph num="(a)"> <text>Freestanding surgical facility;</text> </paragraph> <paragraph num="(b)"> <text>Freestanding endoscopy facility;</text> </paragraph> <paragraph num="(c)"> <text>Freestanding facility utilizing major medical equipment;</text> </paragraph> <paragraph num="(d)"> <text>Freestanding birthing center; or</text> </paragraph> <paragraph num="(e)"> <text>Freestanding kidney dialysis center.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Health care practitioner” means a person who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession.</text> </paragraph> <paragraph num="(6)"> <text>“License” means a document issued by the Secretary to a person to operate a freestanding ambulatory care facility.</text> </paragraph> <paragraph num="(7)"> <text>“Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(9)"> <text>"Unexpected adverse outcomes” means unanticipated negative outcomes, related to a patient's medical treatment and not related to the natural course of the patient’s illness or underlying disease condition.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person may not establish or operate a freestanding ambulatory care facility without obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary.</text> </paragraph> <paragraph num="C."> <text>A license issued under this chapter is not transferable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>A person desiring to operate a facility shall:</text> <paragraph num="(1)"> <text>Be in compliance with all applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>File an application on a written or electronic form provided by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Submit documentation that the Maryland Health Resources Planning Commission has determined that the facility either received a certificate of need or is exempt from certificate of need requirements; and</text> </paragraph> <paragraph num="(4)"> <text>Submit a written description of its quality assurance program as required by Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An officer of a corporation or association shall apply for a license on behalf of the entity. The owner shall apply on behalf of a sole proprietorship. An applicant shall submit the names of the entity's board members, owners, and investors having at least 2 percent ownership.</text> </paragraph> <paragraph num="C."> <text>An authorized individual of a government unit or agency shall apply for a license on behalf of the government unit or agency.</text> </paragraph> <paragraph num="D."> <text>For an existing Medicare-certified facility, the Department shall issue a license within 90 days of receiving:</text> <paragraph num="(1)"> <text>A license application;</text> </paragraph> <paragraph num="(2)"> <text>The license fee; and</text> </paragraph> <paragraph num="(3)"> <text>Evidence of compliance with applicable regulations.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application unconditionally if the applicant complies with all requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application conditionally; or</text> </paragraph> <paragraph num="(3)"> <text>Deny the application if the applicant:</text> <paragraph num="(a)"> <text>Has been convicted of:</text> <paragraph num="(i)"> <text>A felony that relates to Medicaid or Medicare, or</text> </paragraph> <paragraph num="(ii)"> <text>A crime involving moral turpitude; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Denial of License for Prior Revocation or Consent to Surrender License. The Secretary may deny a license to:</text> <paragraph num="(1)"> <text>A corporate applicant if the corporate entity has an owner, director, or officer:</text> <paragraph num="(a)"> <text>Whose conduct caused the revocation of a prior license, or</text> </paragraph> <paragraph num="(b)"> <text>Who held the same or similar position in another corporate entity which had its license revoked;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual applicant:</text> <paragraph num="(a)"> <text>Whose conduct caused the revocation of a prior license, or</text> </paragraph> <paragraph num="(b)"> <text>Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to deny a license.</text> </paragraph> <paragraph num="H."> <text>A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter.</text> </paragraph> <paragraph num="I."> <text>Renewal of License.</text> <paragraph num="(1)"> <text>At least 60 days before a license expires, the licensee shall submit a renewal application to the Secretary on a written or electronic form provided by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspections by Secretary of Health."> <paragraph num="A."> <text>Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to:</text> <paragraph num="(1)"> <text>Survey freestanding ambulatory care facilities as directed by the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(2)"> <text>Verify compliance with licensing regulations; or</text> </paragraph> <paragraph num="(3)"> <text>Investigate complaints.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Noncompliance.</text> <paragraph num="(1)"> <text>If the Secretary determines that a licensee fails to meet any provision of this chapter, the Secretary shall:</text> <paragraph num="(a)"> <text>Advise the licensee of the exact nature of the violation; and</text> </paragraph> <paragraph num="(b)"> <text>Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>This section does not preclude the Secretary from imposing any of the sanctions set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Records and Reports. The facility shall make its records and reports available to the Department or its designee for inspection. On the written request of the Department, the facility shall immediately provide photocopies of records and reports, including clinical records of patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Administration."> <paragraph num="A."> <text>The licensee is responsible for the overall conduct of the facility and for compliance with applicable laws and regulations.</text> </paragraph> <paragraph num="B."> <text>Governing Body. The governing body shall identify the administrator who has been given the authority and responsibility for overall policy and fiscal management of the facility. The governing body shall develop a written organizational plan.</text> </paragraph> <paragraph num="C."> <text>Administrator. The administrator is responsible for the daily operation of the facility, including but not limited to:</text> <paragraph num="(1)"> <text>Implementing the facility's policies and coordinating the provision of services that the facility provides;</text> </paragraph> <paragraph num="(2)"> <text>Organizing and coordinating the administrative functions of the facility;</text> </paragraph> <paragraph num="(3)"> <text>Establishing procedures for the accountability of those personnel involved in patient care;</text> </paragraph> <paragraph num="(4)"> <text>Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="(5)"> <text>Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; and</text> </paragraph> <paragraph num="(6)"> <text>Participating in the development of organizational and fiscal planning for the facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Policies and Procedures. The administrator, in consultation with the medical director, shall develop and implement policies and procedures governing the operation of the facility which include at a minimum:</text> <paragraph num="(1)"> <text>A description of the scope and delivery of services provided by the facility either directly or through contractual arrangements;</text> </paragraph> <paragraph num="(2)"> <text>A description of the provision of complete and partial charity care for indigent and Medicaid patients to promote access to all services regardless of an individual's ability to pay;</text> </paragraph> <paragraph num="(3)"> <text>Personnel practices;</text> </paragraph> <paragraph num="(4)"> <text>Discharge protocols and aftercare plans;</text> </paragraph> <paragraph num="(5)"> <text>Postoperative recovery, if applicable;</text> </paragraph> <paragraph num="(6)"> <text>The transfer or referral of patients who require services that are not provided by the facility;</text> </paragraph> <paragraph num="(7)"> <text>The transportation of a patient to the nearest appropriate hospital in the event of an emergency situation;</text> </paragraph> <paragraph num="(8)"> <text>Infection control for patients and staff;</text> </paragraph> <paragraph num="(9)"> <text>Pertinent safety practices, including the control of fire and mechanical hazards; and</text> </paragraph> <paragraph num="(10)"> <text>Preventive maintenance for equipment to ensure proper operation and safety.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The administrator shall ensure that all:</text> <paragraph num="(1)"> <text>Policies and procedures are reviewed by staff at least annually and are revised as necessary;</text> </paragraph> <paragraph num="(2)"> <text>Policies and procedures are available at all times for staff inspection and use; and</text> </paragraph> <paragraph num="(3)"> <text>Appropriate personnel implement all policies and procedures as adopted.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Personnel."> <paragraph num="A."> <text>The administrator shall ensure that all personnel:</text> <paragraph num="(1)"> <text>Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties;</text> </paragraph> <paragraph num="(2)"> <text>Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and</text> </paragraph> <paragraph num="(3)"> <text>Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The administrator shall have a sufficient number of qualified professional staff on duty at all times to ensure safe operation and maintenance of the facility.</text> </paragraph> <paragraph num="C."> <text>The facility shall have job descriptions on file for all personnel.</text> </paragraph> <paragraph num="D."> <text>The administrator shall ensure that all personnel are free from active reportable airborne communicable disease as evidenced by a physician's or other qualified health care practitioner's statement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Quality Assurance Program."> <paragraph num="A."> <text>The administrator shall ensure that the facility develops and maintains a quality assurance program which includes:</text> <paragraph num="(1)"> <text>Monitoring and evaluation of the quality of patient care;</text> </paragraph> <paragraph num="(2)"> <text>Identification, evaluation, and resolution of care problems; and</text> </paragraph> <paragraph num="(3)"> <text>A peer review process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.</text> </paragraph> <paragraph num="C."> <text>Peer Review. The administrator shall ensure that the facility establishes a peer review process that includes:</text> <paragraph num="(1)"> <text>A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually;</text> </paragraph> <paragraph num="(2)"> <text>Procedures, approved by a qualified health care practitioner to identify and minimize risks to the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of each health care practitioner's annual evaluation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Practitioner Performance Evaluation in a Facility.</text> <paragraph num="(1)"> <text>The administrator shall ensure that the facility establishes a practitioner performance evaluation process that includes a review of care which shall:</text> <paragraph num="(a)"> <text>Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes;</text> </paragraph> <paragraph num="(b)"> <text>Be based on objective review standards;</text> </paragraph> <paragraph num="(c)"> <text>Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and</text> </paragraph> <paragraph num="(d)"> <text>Be conducted by at least two members of the medical staff who:</text> <paragraph num="(i)"> <text>As appropriate, are of the same specialty as the member of the medical staff under review; and</text> </paragraph> <paragraph num="(ii)"> <text>Have been trained in the freestanding ambulatory care facility’s policies and procedures regarding practitioner performance evaluation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer.</text> </paragraph> <paragraph num="(3)"> <text>A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Equipment Quality Control.</text> <paragraph num="(1)"> <text>The administrator shall ensure that the facility develops a quality control procedure to monitor the safety and performance of all biomedical equipment.</text> </paragraph> <paragraph num="(2)"> <text>In developing its procedures, the administrator shall consider:</text> <paragraph num="(a)"> <text>FDA recommendations; and</text> </paragraph> <paragraph num="(b)"> <text>The equipment manufacturer's recommendations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Documentation.</text> <paragraph num="(1)"> <text>At the time of application, the applicant shall submit a written description of the facility's quality assurance program which includes, at a minimum:</text> <paragraph num="(a)"> <text>A description of how the facility will comply with §A of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The manner in which information will be collected.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The facility shall submit any revisions to its quality assurance program at the time of licensure renewal.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Quality Assurance Records. The facility shall document the following information for all quality assurance activities:</text> <paragraph num="(1)"> <text>A description of identified problems;</text> </paragraph> <paragraph num="(2)"> <text>Findings;</text> </paragraph> <paragraph num="(3)"> <text>Conclusions;</text> </paragraph> <paragraph num="(4)"> <text>Recommendations;</text> </paragraph> <paragraph num="(5)"> <text>Actions taken;</text> </paragraph> <paragraph num="(6)"> <text>Results; and</text> </paragraph> <paragraph num="(7)"> <text>Follow-up.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Medical Records."> <paragraph num="A."> <text>The facility shall maintain a complete, comprehensive, and accurate medical record for each patient.</text> </paragraph> <paragraph num="B."> <text>Each patient's medical record shall include at least the following:</text> <paragraph num="(1)"> <text>Patient identifier;</text> </paragraph> <paragraph num="(2)"> <text>Significant medical history and results of a physical examination;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of care or services provided;</text> </paragraph> <paragraph num="(4)"> <text>Evidence of consent; and</text> </paragraph> <paragraph num="(5)"> <text>Discharge diagnosis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The facility shall:</text> <paragraph num="(1)"> <text>Send a copy of the medical record with the patient on referral to another health care provider or on transfer to a hospital;</text> </paragraph> <paragraph num="(2)"> <text>Use the medical record, if appropriate, in instructing the patient and the family; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Patients' Rights and Responsibilities."> <paragraph num="A."> <text>The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities.</text> </paragraph> <paragraph num="B."> <text>The facility shall make the policies and procedures available to patients, guardians, or other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public.</text> </paragraph> <paragraph num="C."> <text>The policies and procedures shall ensure that:</text> <paragraph num="(1)"> <text>The facility informs patients of services that are available and the charges for services not covered by third-party payors;</text> </paragraph> <paragraph num="(2)"> <text>A physician, dentist, podiatrist, or other qualified health care practitioner informs patients of their medical conditions unless medically contraindicated as documented in their medical records;</text> </paragraph> <paragraph num="(3)"> <text>All patients are afforded an opportunity to participate in planning their medical treatments and to refuse to participate in experimental research; and</text> </paragraph> <paragraph num="(4)"> <text>All patients are ensured confidential treatment of their medical records, and may approve or refuse release of records to any individual outside the facility, except as provided by federal or State law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Physical Environment."> <paragraph num="A."> <text>The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction.</text> </paragraph> <paragraph num="B."> <text>The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06.</text> </paragraph> <paragraph num="C."> <text>The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Complaint Investigations."> <paragraph num="A."> <text>The Secretary may inspect a facility to investigate and resolve any complaint concerning patient care and safety.</text> </paragraph> <paragraph num="B."> <text>If the complaint concerns the performance of a health care practitioner or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the health care practitioner to provide services under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the licensee informing the licensee of the emergency suspension, giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension, and notifying the licensee of the licensee's right to request a hearing and to be represented by counsel.</text> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is immediately suspended, the licensee shall:</text> <paragraph num="(1)"> <text>Immediately return the license to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Stop providing services immediately.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter.</text> </paragraph> <paragraph num="F."> <text>The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .16 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="G."> <text>If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Revocation of License."> <paragraph num="A."> <text>Revocation of License. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Secretary may revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Has been convicted of:</text> <paragraph num="(a)"> <text>A felony that relates to Medicaid or Medicare, or</text> </paragraph> <paragraph num="(b)"> <text>A crime involving moral turpitude; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to revoke a license.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall notify the licensee in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the licensee is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the licensee is required to surrender the license to the Department if the revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Penalties."> <paragraph num="A."> <text>Criminal Penalty. A person who violates any provision of this chapter is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000, or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>Each day that a violation is continued after the first conviction is a separate offense.</text> </paragraph> <paragraph num="C."> <text>Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter.</text> </paragraph> <paragraph num="D."> <text>When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 23, 1999 (26:17 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, I amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="02" heading="Freestanding Birthing Centers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Certified nurse midwife” has the meaning stated in COMAR 10.27.05.01.</text> </paragraph> <paragraph num="(3)"> <text>Freestanding Birthing Center.</text> <paragraph num="(a)"> <text>“Freestanding birthing center” means a facility that provides nurse midwife services through individuals licensed to practice under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Freestanding birthing center” does not include:</text> <paragraph num="(i)"> <text>Birthing services that are licensed or accredited as a unit of a hospital; or</text> </paragraph> <paragraph num="(ii)"> <text>The private residence of the patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Immediate action” means all actions the freestanding birthing center has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely.</text> </paragraph> <paragraph num="(5)"> <text>Immediate Jeopardy.</text> <paragraph num="(a)"> <text>“Immediate jeopardy” means a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public.</text> </paragraph> <paragraph num="(b)"> <text>“Immediate jeopardy” consists of three components:</text> <paragraph num="(i)"> <text>Noncompliance with this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Serious injury, harm, or death; and</text> </paragraph> <paragraph num="(iii)"> <text>The need for immediate action.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Informal dispute resolution (IDR)” means an informal process that provides a freestanding birthing center the opportunity to dispute one or more deficiencies cited in a written Statement of Deficiencies issued by the Department or the Department’s designee related to a recent survey.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed certified midwife” has the meaning stated in Health Occupations Article, §8-6D-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed direct-entry midwife” has the meaning stated in COMAR 10.64.01.01.</text> </paragraph> <paragraph num="(9)"> <text>“Midwifery” means the antepartum, intrapartum, and postpartum management and care of birthing persons and their newborns.</text> </paragraph> <paragraph num="(10)"> <text>“Need for immediate action” means that immediate corrective action is necessary to remove the jeopardy.</text> </paragraph> <paragraph num="(11)"> <text>“Newborn” means an infant in the first 28 days of life.</text> </paragraph> <paragraph num="(12)"> <text>“Noncompliance” means the freestanding birthing center is non-compliant with one or more licensure requirements of this chapter.</text> </paragraph> <paragraph num="(13)"> <text>Normal Maternity.</text> <paragraph num="(a)"> <text>“Normal maternity” means a low risk, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.</text> </paragraph> <paragraph num="(b)"> <text>“Normal maternity” does not include the use of drugs for induction or augmentation of labor, general and regional anesthesia, vacuum extractors, forceps, recorded electronic fetal monitors, cesarean section, surgical procedures other than episiotomy or perineal repair, intrapartum care provided prior to 36 weeks gestation, or intrapartum care provided after 42 weeks gestation.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Healthcare Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(15)"> <text>“Plan of Correction” means a written plan submitted by the freestanding birthing center to the OHCQ which documents steps the freestanding birthing center will take to come into compliance with the licensure requirements.</text> </paragraph> <paragraph num="(16)"> <text>“Removal of the immediate jeopardy” means that the freestanding birthing center has implemented the removal plan, and the OHCQ has verified that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment, or death would occur or recur.</text> </paragraph> <paragraph num="(17)"> <text>“Serious injury, harm, or death” means a situation which has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public.</text> </paragraph> <paragraph num="(18)"> <text>“Statement of Deficiencies” means the written notification that the OHCQ issues to the free standing birthing center that contains a listing of deficiencies cited that require correction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation By Reference."> <text>In this chapter, the following document is incorporated by reference, National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="License Requirements."> <text>A freestanding birthing center shall only provide normal maternity care and shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>An applicant shall submit:</text> <paragraph num="(1)"> <text>An application on a written or electronic form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>All other reasonable documents as required by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>A business email address for the applicant or their organization.</text> </paragraph> </paragraph> <paragraph num="B."> <text>License Application Administratively Closed.</text> <paragraph num="(1)"> <text>An application is not complete until the Department has received the completed license application and all required documents.</text> </paragraph> <paragraph num="(2)"> <text>After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application.</text> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is administratively closed may reapply for a license by submitting a new application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Voiding of License.</text> <paragraph num="(1)"> <text>Maryland State Department of Assessments and Taxation (SDAT).</text> <paragraph num="(a)"> <text>A freestanding birthing center shall remain in good standing with (SDAT).</text> </paragraph> <paragraph num="(b)"> <text>If the freestanding birthing center fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the freestanding birthing center's license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ceases the Provision of Services.</text> <paragraph num="(a)"> <text>A license is void if the freestanding birthing center ceases to provide services to patients for a period of 180 consecutive days.</text> </paragraph> <paragraph num="(b)"> <text>The owner shall immediately cease all use of the previously issued freestanding birthing center license when the license is voided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Current Business Email Address. A freestanding birthing center is required to maintain a current business email address on file with the OHCQ.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspection by OHCQ."> <paragraph num="A."> <text>A licensee operating a freestanding birthing center shall undergo a routine annual survey.</text> </paragraph> <paragraph num="B."> <text>A licensee shall allow an on-site survey by the Department at any time during the center’s normal hours of operation to evaluate the center’s compliance with the applicable requirements and standards of this chapter.</text> </paragraph> <paragraph num="C."> <text>Center employees shall make data and records accessible within a reasonable time during the on-site survey.</text> </paragraph> <paragraph num="D."> <text>Notice of Deficiencies.</text> <paragraph num="(1)"> <text>If a survey identifies noncompliance with a requirement, the Secretary shall:</text> <paragraph num="(a)"> <text>Issue a written Statement of Deficiencies that cites each deficiency;</text> </paragraph> <paragraph num="(b)"> <text>Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies;</text> </paragraph> <paragraph num="(c)"> <text>Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and</text> </paragraph> <paragraph num="(d)"> <text>Offer the freestanding birthing center the opportunity for IDR.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Plan of Correction.</text> <paragraph num="(1)"> <text>The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including:</text> <paragraph num="(a)"> <text>How the freestanding birthing center will correct each deficiency;</text> </paragraph> <paragraph num="(b)"> <text>The date by which each deficient practice will be corrected;</text> </paragraph> <paragraph num="(c)"> <text>How the freestanding birthing center will prevent the deficient practice from recurring; and</text> </paragraph> <paragraph num="(d)"> <text>Who will be responsible for ensuring the deficiency will not reoccur.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction.</text> </paragraph> <paragraph num="(3)"> <text>A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Immediate Jeopardy.</text> <paragraph num="(1)"> <text>Declaration of Immediate Jeopardy.</text> <paragraph num="(a)"> <text>When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared.</text> </paragraph> <paragraph num="(b)"> <text>The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Removal Plan. The freestanding birthing center shall submit a written removal plan to the OHCQ that includes:</text> <paragraph num="(a)"> <text>The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring;</text> </paragraph> <paragraph num="(b)"> <text>All actions to remove past, present, and future jeopardy; and</text> </paragraph> <paragraph num="(c)"> <text>The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>OHCQ's Review of the Removal Plan.</text> <paragraph num="(a)"> <text>The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.</text> </paragraph> <paragraph num="(b)"> <text>The OHCQ shall verify that the freestanding birthing center has implemented the removal plan.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur.</text> </paragraph> <paragraph num="(5)"> <text>Plan of Correction. If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Informal Dispute Resolution (IDR).</text> <paragraph num="(1)"> <text>A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.</text> </paragraph> <paragraph num="(2)"> <text>The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies.</text> </paragraph> <paragraph num="(3)"> <text>The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration.</text> </paragraph> <paragraph num="(4)"> <text>At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing.</text> </paragraph> <paragraph num="(5)"> <text>IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department.</text> </paragraph> <paragraph num="(6)"> <text>The IDR process may not delay the effective date of any enforcement action.</text> </paragraph> <paragraph num="(7)"> <text>In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process.</text> </paragraph> <paragraph num="(8)"> <text>There is no appeal of the Department’s decision in an IDR.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Personnel."> <paragraph num="A."> <text>Administrator. The licensee shall appoint an administrator of the freestanding birthing center who is responsible for the:</text> <paragraph num="(1)"> <text>Daily administration of the center; and</text> </paragraph> <paragraph num="(2)"> <text>Training and supervision of all nonprofessional staff, unlicensed staff, and volunteers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Director of Midwifery Services. The administrator shall appoint a certified nurse midwife or licensed certified midwife as director of midwifery services who is responsible for the employment, training, and supervision of the licensed professional staff</text> </paragraph> <paragraph num="C."> <text>Clinical Director.</text> <paragraph num="(1)"> <text>The clinical director shall:</text> <paragraph num="(a)"> <text>Be a certified nurse midwife;</text> </paragraph> <paragraph num="(b)"> <text>Be a licensed certified midwife; or</text> </paragraph> <paragraph num="(c)"> <text>Be a physician with:</text> <paragraph num="(i)"> <text>Board certification in a specialty that provides services for pregnant and postpartum patients; or</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate experience in the care of pregnant and postpartum patients; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be responsible for advising and consulting with the center staff on all matters related to medical management of pregnancy, birth, postpartum, newborn, and gynecologic health care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The same individual may be clinical director and the director of midwifery services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Two licensed staff individuals in midwifery, one of whom shall be a certified nurse midwife or licensed certified midwife, shall:</text> <paragraph num="(1)"> <text>Attend each birth; and</text> </paragraph> <paragraph num="(2)"> <text>Be currently certified in:</text> <paragraph num="(a)"> <text>Adult cardiopulmonary resuscitation equivalent to the American Heart Association Class C basic life support; and</text> </paragraph> <paragraph num="(b)"> <text>Neonatal resuscitation by a course endorsed by the American Academy of Pediatrics and the American Heart Association.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Clinical Practice Guidelines."> <paragraph num="A."> <text>The clinical director and director of midwifery shall develop clinical practice guidelines for the management of routine and emergency care of the patient and the fetus or newborn during pregnancy, birth, and postpartum through discharge, whether through completion of the pregnancy or referral or transfer to other levels of care.</text> </paragraph> <paragraph num="B."> <text>The clinical practice guidelines shall include, at a minimum, procedures for the:</text> <paragraph num="(1)"> <text>Transfer of patients or newborns for appropriate hospital obstetric and newborn care;</text> </paragraph> <paragraph num="(2)"> <text>Monitoring of fetal heart tones consistent with the current standards of care; and</text> </paragraph> <paragraph num="(3)"> <text>Use of ultrasound imaging that is:</text> <paragraph num="(a)"> <text>Consistent with the current standards of care; and</text> </paragraph> <paragraph num="(b)"> <text>Within the scope of practice for a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Certified nurse midwife; or</text> </paragraph> <paragraph num="(iii)"> <text>Licensed certified midwife.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The administrator shall:</text> <paragraph num="(1)"> <text>Ensure that all clinical practice guidelines are fully implemented by the clinical staff;</text> </paragraph> <paragraph num="(2)"> <text>Periodically review the non-clinical policies and revise them when necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Make the [protocols] clinical practice guidelines available to staff for reference on site at all times.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed direct-entry midwife, certified nurse midwife, and licensed certified midwife practicing in a birthing center shall remain in compliance with applicable practice guidelines including but not limited to:</text> <paragraph num="(1)"> <text>Health Occupations Article, §8-6C-08, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.64.01.10;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.27.05.04; and</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.27.05.01(a)(8).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Consultation."> <text>A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall consult or collaborate with another health care practitioner who has the knowledge, skills, and expertise to manage a clinical issue, as needed or as required in Health Occupations Article, §8-6C-04, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Referral System."> <text>A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall refer and transfer patients with complications beyond their scope of practice to a health care practitioner with the knowledge, skills, and experience to manage the client.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Hospitalization."> <paragraph num="A."> <text>A freestanding birthing center shall have a written procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required.</text> </paragraph> <paragraph num="B."> <text>Procedures for emergency transfer to a hospital shall include, at minimum:</text> <paragraph num="(1)"> <text>Written clinical practice guidelines related to emergency transfer procedures;</text> </paragraph> <paragraph num="(2)"> <text>A mechanism for notifying the hospital of a pending emergency case;</text> </paragraph> <paragraph num="(3)"> <text>A mechanism for arranging appropriate transportation to the hospital; and</text> </paragraph> <paragraph num="(4)"> <text>Protocols for transmitting a copy of the patient’s medical record to the hospital.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A freestanding birthing center shall conduct a transfer drill with staff that may be involved in patient transfers at least once a year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Quality Assurance Program."> <paragraph num="A."> <text>A freestanding birthing center shall develop and implement a quality assurance program.</text> </paragraph> <paragraph num="B."> <text>A freestanding birthing center shall collect the following evaluative data in addition to that required in COMAR 10.05.01.08:</text> <paragraph num="(1)"> <text>Number of births;</text> </paragraph> <paragraph num="(2)"> <text>Intrapartum transfer rates and indications for transfer; and</text> </paragraph> <paragraph num="(3)"> <text>Postpartum maternal and neonatal hospital admissions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A freestanding birthing center shall conduct a quarterly review of all patients transferred to an emergency department or a hospital.</text> </paragraph> <paragraph num="D."> <text>Process of Filing a Complaint. The freestanding birthing center shall have a written process that describes how patients are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Physical Plant."> <paragraph num="A."> <text>Bedrooms. A freestanding birthing center shall:</text> <paragraph num="(1)"> <text>Locate bedrooms so as to provide unimpeded, rapid access to an exit of the building where emergency transportation vehicles may be accommodated;</text> </paragraph> <paragraph num="(2)"> <text>Have bedrooms that can accommodate:</text> <paragraph num="(a)"> <text>A double bed or a bed large enough to safely accommodate patient and baby,</text> </paragraph> <paragraph num="(b)"> <text>Birth attendants and support persons,</text> </paragraph> <paragraph num="(c)"> <text>Space for supplies, equipment, and family belongings, and</text> </paragraph> <paragraph num="(d)"> <text>Access to a sink with hot and cold running water equipped with elbow-wrist controls such as are common in home kitchens.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Toilet Facilities. A freestanding birthing center shall make available separate fixed toilet facilities to the laboring patient and separate toilet facilities for family and staff use.</text> </paragraph> <paragraph num="C."> <text>Bath Facilities. A freestanding birthing center shall make bath and shower facilities available to the laboring patient and have separate washing facilities available for staff and family.</text> </paragraph> <paragraph num="D."> <text>Storage, Utility, and Laundry Facilities. A freestanding birthing center shall have facilities that are designed and equipped for washing, sterilizing, storing, and handling equipment, linens, and medical supplies in a manner which ensures separation of clean linen, and sterile supplies and equipment from those that are soiled or contaminated.</text> </paragraph> <paragraph num="E."> <text>Heating and Ventilation. A freestanding birthing center shall have a safe and adequate source of heat and ventilation capable of maintaining temperature in the birthing unit between 75°F and 85°F.</text> </paragraph> <paragraph num="F."> <text>Lighting and Power. A freestanding birthing center shall have adequate lighting in the birthing rooms.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Fire Safety and Emergency Preparedness."> <paragraph num="A."> <text>Fire Safety Protection.</text> <paragraph num="(1)"> <text>Smoke Alarms. A freestanding birthing center shall place smoke alarms on each floor and at points as recommended by the State Fire Marshal or local fire authority. A freestanding birthing center shall have alarms that are audible throughout the center.</text> </paragraph> <paragraph num="(2)"> <text>Fire Extinguishers. A freestanding birthing center shall provide at least one approved fire extinguisher on each floor, including below ground level.</text> </paragraph> <paragraph num="(3)"> <text>Lighting and Power. A freestanding birthing center shall ensure that:</text> <paragraph num="(a)"> <text>Exits are illuminated during time of occupancy; and</text> </paragraph> <paragraph num="(b)"> <text>Emergency lighting is located to provide illumination in event of a power failure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Power Outage. A freestanding birthing center shall have:</text> <paragraph num="(1)"> <text>A written plan to address power outages; and</text> </paragraph> <paragraph num="(2)"> <text>Annual staff training relating to power outages.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Evacuation.</text> <paragraph num="(1)"> <text>A freestanding birthing center shall make written copies of its fire evacuation plan available to all personnel and instruct all personnel in the implementation of the evacuation plan.</text> </paragraph> <paragraph num="(2)"> <text>A freestanding birthing center shall keep all personnel informed of their responsibilities under the plan and conduct a supervised evacuation drill at least once a year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Equipment."> <paragraph num="A."> <text>Equipment and furnishings shall be constructed of materials that are easily cleaned and maintained and shall include, at a minimum:</text> <paragraph num="(1)"> <text>A heat source for infant examination or resuscitation;</text> </paragraph> <paragraph num="(2)"> <text>A transfer isolette or demonstrated capability of ready access to a transfer isolette;</text> </paragraph> <paragraph num="(3)"> <text>A sterilizer or demonstration of sterilizing capability;</text> </paragraph> <paragraph num="(4)"> <text>Blood pressure equipment, thermometers, and fetoscope or doptone;</text> </paragraph> <paragraph num="(5)"> <text>Intravenous equipment;</text> </paragraph> <paragraph num="(6)"> <text>Adult and neonatal resuscitation equipment including, but not limited to, oxygen equipment for patient and newborn that is stored in accordance with Standards for Health Care Facilities, NFPA 99; and</text> </paragraph> <paragraph num="(7)"> <text>Instruments for delivery, episiotomy, and repair.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Laundry.</text> <paragraph num="(1)"> <text>A freestanding birthing center shall provide for the sanitary handling of soiled linens in accordance with 29 CFR §1910.1030, which is incorporated by reference.</text> </paragraph> <paragraph num="(2)"> <text>A freestanding birthing center may have on-site laundry facilities or use a laundry service that is experienced in handling linens for health care facilities.</text> </paragraph> <paragraph num="(3)"> <text>When a freestanding birthing center uses on-site laundry facilities, the center shall disinfect soiled linens by using one of the following methods:</text> <paragraph num="(a)"> <text>Hot water at 160°F; or</text> </paragraph> <paragraph num="(b)"> <text>A low-temperature wash formula which specifies time, temperature, concentration, and pH control in conjunction with chlorine bleach as recommended by the detergent manufacturer for use in a health care setting.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A freestanding birthing center shall maintain an adequate linen supply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Health Record."> <paragraph num="A."> <text>In addition to meeting the requirements of this regulation, a freestanding birthing center shall comply with the requirements of COMAR 10.05.01.09.</text> </paragraph> <paragraph num="B."> <text>The health record of each patient shall contain documentation of all services provided while the patient and the fetus or newborn are under the care of the freestanding birthing center, including reports by outside providers who have examined or treated the patient at the request of the center.</text> </paragraph> <paragraph num="C."> <text>A freestanding birthing center shall:</text> <paragraph num="(1)"> <text>Send a copy of the health record with the patient or newborn, or both, on referral to another health care provider or on transfer to a hospital; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain birth and death certificates on file, as required by Health-General Article, Title 4, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 23, 1999 (26:17 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 8, 2016 (43:24 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective December 8, 2016 (43:24 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 13, 2025 (52:20 Md. R. 1000)</annotation> </annotations> </chapter> <chapter num="03" heading="Freestanding Major Medical Equipment Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Freestanding Facility Operating Major Medical Equipment.</text> <paragraph num="(a)"> <text>“Freestanding facility operating major medical equipment” means a facility using major medical equipment.</text> </paragraph> <paragraph num="(b)"> <text>“Freestanding facility operating major medical equipment” does not include any freestanding ambulatory care facilities or service owned or operated by a hospital and regulated under COMAR 10.07.01.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“JCAHO” means the Joint Commission on Accreditation of Healthcare Organizations, a private organization that creates standards, surveys, and accredits hospitals and health-related facilities.</text> </paragraph> <paragraph num="(3)"> <text>“Major medical equipment” means:</text> <paragraph num="(a)"> <text>All cardiac catheterization equipment necessary to perform heart catheterization;</text> </paragraph> <paragraph num="(b)"> <text>A computed tomography (CT) scanner;</text> </paragraph> <paragraph num="(c)"> <text>A lithotriptor;</text> </paragraph> <paragraph num="(d)"> <text>Radiation therapy equipment, including a linear accelerator; or</text> </paragraph> <paragraph num="(e)"> <text>A magnetic resonance imager (MRI).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Supervisor” means a physician who is licensed by the Board of Physician Quality Assurance and who has expertise in the operation of major medical equipment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>A facility operating major medical equipment shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>An owner of mobile major medical equipment shall obtain a license under this chapter.</text> </paragraph> <paragraph num="C."> <text>A facility operating major medical equipment that is engaged exclusively in biomedical research is not required to be licensed under this chapter if:</text> <paragraph num="(1)"> <text>Charges for any health care service provided with the equipment will not be paid by any patient or third-party payor; and</text> </paragraph> <paragraph num="(2)"> <text>The capital costs associated with the equipment and any related construction or renovation are not included in patient charges.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedure."> <paragraph num="A."> <text>A person desiring to establish or operate a facility that operates major medical equipment shall submit an application for licensure.</text> </paragraph> <paragraph num="B."> <text>The following information for each piece of equipment shall accompany the application:</text> <paragraph num="(1)"> <text>Manufacturer and model of the equipment;</text> </paragraph> <paragraph num="(2)"> <text>Address where the equipment is to be located; and</text> </paragraph> <paragraph num="(3)"> <text>Qualifications of the licensed physician who will be supervising the use of the equipment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant or licensee shall submit a nonrefundable fee of $700 with an application for:</text> <paragraph num="(1)"> <text>Initial licensure; or</text> </paragraph> <paragraph num="(2)"> <text>License renewal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Inspections by the Secretary."> <paragraph num="A."> <text>The Secretary may verify compliance with licensing requirements through on-site random sample record reviews.</text> </paragraph> <paragraph num="B."> <text>For the purpose of verifying compliance, the Secretary shall have access to:</text> <paragraph num="(1)"> <text>The facility or office where the equipment is located;</text> </paragraph> <paragraph num="(2)"> <text>Patients' medical records, including image or scan records;</text> </paragraph> <paragraph num="(3)"> <text>Quality assurance records, including peer review documentation;</text> </paragraph> <paragraph num="(4)"> <text>Records documenting in-service training on use of the equipment;</text> </paragraph> <paragraph num="(5)"> <text>Records verifying personnel training;</text> </paragraph> <paragraph num="(6)"> <text>Equipment quality control and inspection records;</text> </paragraph> <paragraph num="(7)"> <text>Radiation safety reports;</text> </paragraph> <paragraph num="(8)"> <text>Records of referrals and evidence of appropriate use of equipment;</text> </paragraph> <paragraph num="(9)"> <text>Policies and procedures that ensure safe operation of equipment; and</text> </paragraph> <paragraph num="(10)"> <text>Qualifications of personnel:</text> <paragraph num="(a)"> <text>Permitted to supervise use of the major medical equipment,</text> </paragraph> <paragraph num="(b)"> <text>Permitted to operate the major medical equipment, and</text> </paragraph> <paragraph num="(c)"> <text>Responsible for maintenance of the major medical equipment.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Personnel."> <paragraph num="A."> <text>Operators of Magnetic Resonance Imager (MRI) Equipment. Operators of MRI equipment shall demonstrate competency to successfully and safely complete magnetic resonance procedures.</text> </paragraph> <paragraph num="B."> <text>Operators of Radiation-Producing Equipment. The licensee shall ensure that operators of radiation-producing equipment are qualified in accordance with Health Occupations Article, §§14-306 and 14-606, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Students and Graduate Technologists. This regulation does not prohibit students or graduate technologists from operating equipment, if the students or technologists are directly monitored by a supervisor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Quality Assurance Program."> <paragraph num="A."> <text>A facility operating major medical equipment shall develop and implement:</text> <paragraph num="(1)"> <text>A quality assurance program in compliance with the guidelines outlined in COMAR 10.05.01.08; and</text> </paragraph> <paragraph num="(2)"> <text>Additional quality assurance requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Scope. The quality assurance program shall apply to all personnel supervising or operating major medical equipment.</text> </paragraph> <paragraph num="C."> <text>Appropriate Use.</text> <paragraph num="(1)"> <text>The administrator shall develop a procedure to monitor referral and appropriate use for each procedure performed using the major medical equipment, ensuring that:</text> <paragraph num="(a)"> <text>Referrals are consistent with the health care practitioner's scope of practice as defined in the Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The supervisor of major medical equipment is available to a referring health care practitioner to discuss appropriate use; and</text> </paragraph> <paragraph num="(c)"> <text>If the supervisor of major medical equipment questions the appropriateness of a requested procedure, the supervisor shall contact the referring health care practitioner for additional information relating to the appropriateness of using the equipment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When considering appropriate use, the supervisor of major medical equipment shall consider the patient's risks for undergoing specific testing, and the effectiveness of the particular equipment modality to aid in diagnosis.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The supervisor of the major medical equipment shall monitor the quality assurance program to determine the effectiveness of the delivery of services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Operating Standards for Safety."> <paragraph num="A."> <text>A person may not operate major medical equipment unless the operator uses safety measures to protect the patient and the operator in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The administrator shall ensure that all equipment:</text> <paragraph num="(1)"> <text>Is manufactured according to the requirements of 21 CFR 800—1299, which is incorporated by reference;</text> </paragraph> <paragraph num="(2)"> <text>Is appropriately labeled and includes an operating manual;</text> </paragraph> <paragraph num="(3)"> <text>Is considered safe and effective and approved for marketing by receipt of an FDA classification or a letter of approval according to 21 CFR 800—1050.10, which is incorporated by reference; and</text> </paragraph> <paragraph num="(4)"> <text>Meets all applicable standards for equipment adopted by the Division of Radiation Control of the Department of the Environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Safe Operation of Equipment. To ensure safe operation of the equipment, the administrator shall:</text> <paragraph num="(1)"> <text>Develop safety and performance testing procedures;</text> </paragraph> <paragraph num="(2)"> <text>Maintain records of inspection and test results;</text> </paragraph> <paragraph num="(3)"> <text>Develop procedures for identifying equipment malfunctions;</text> </paragraph> <paragraph num="(4)"> <text>Provide instruction and training for equipment operators;</text> </paragraph> <paragraph num="(5)"> <text>Develop policies and procedures that include the following safety rules:</text> <paragraph num="(a)"> <text>Proper safety precautions against fire, explosion, and electrical or mechanical hazards,</text> </paragraph> <paragraph num="(b)"> <text>Guidelines for the management of patients developing emergency situations while undergoing testing, and</text> </paragraph> <paragraph num="(c)"> <text>Safety precautions for equipment that emits radiation and magnetic fields;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Develop protocols and procedures to ensure that patients, operators, and individuals are not exposed to unnecessary hazards; and</text> </paragraph> <paragraph num="(7)"> <text>Ensure that operators are familiar with the most current safety procedures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Medical Records."> <paragraph num="A."> <text>A facility operating major medical equipment shall comply with all requirements of COMAR 10.05.01.09 and the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>A facility operating major medical equipment shall maintain a medical record for each patient on whom a test is performed and make the information available to the Secretary on request.</text> </paragraph> <paragraph num="C."> <text>Each patient's medical record shall include the following information:</text> <paragraph num="(1)"> <text>Symptoms exhibited by the patient;</text> </paragraph> <paragraph num="(2)"> <text>Suspected diagnosis before the test or procedure; and</text> </paragraph> <paragraph num="(3)"> <text>Nature of findings.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 23, 1999 (26:17 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="04" heading="Freestanding Kidney Dialysis Centers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>"Center administrator" means an individual appointed by the governing body who is responsible for the center's daily operation and the duties set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Certified nursing assistant—dialysis technician (CNA-DT)” means an individual certified by the Maryland Board of Nursing as a certified nursing assistant—dialysis technician (CNA-DT).</text> </paragraph> <paragraph num="(3)"> <text>“Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §405.2102, as amended, which is incorporated by reference.</text> </paragraph> <paragraph num="(3-1)"> <text>“In-center daytime hemodialysis” means a hemodialysis treatment that:</text> <paragraph num="(a)"> <text>Usually lasts 3 to 5 hours;</text> </paragraph> <paragraph num="(b)"> <text>Is performed on a routine basis, usually three times a week, to treat a chronic condition; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided in a kidney dialysis center during daytime hours.</text> </paragraph> </paragraph> <paragraph num="(3-2)"> <text>“In-center nocturnal hemodialysis” means a hemodialysis treatment that:</text> <paragraph num="(a)"> <text>Lasts 6 to 9 hours;</text> </paragraph> <paragraph num="(b)"> <text>Is performed on a routine basis, usually three times a week, to treat a chronic condition; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided in a kidney dialysis center.</text> </paragraph> </paragraph> <paragraph num="(3-3)"> <text>“Interdisciplinary team (IDT)” means a multidisciplinary team:</text> <paragraph num="(a)"> <text>Consisting of, at a minimum:</text> <paragraph num="(i)"> <text>The patient or the patient’s designee, if the patient chooses;</text> </paragraph> <paragraph num="(ii)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(iii)"> <text>A physician;</text> </paragraph> <paragraph num="(iv)"> <text>A nurse practitioner or physician assistant treating the patient for ESRD;</text> </paragraph> <paragraph num="(v)"> <text>A social worker; and</text> </paragraph> <paragraph num="(vi)"> <text>A dietitian; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Whose professional members have dialysis experience.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Kidney Dialysis Center.</text> <paragraph num="(a)"> <text>“Kidney dialysis center” means a facility that provides hemodialysis or chronic peritoneal dialysis.</text> </paragraph> <paragraph num="(b)"> <text>“Kidney dialysis center” does not include a center or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Patient comprehensive assessment” means an individualized comprehensive assessment that reflects the patient’s psychological, social, medical, dietary, and rehabilitation needs and identifies the care required to meet those needs as well as individualized modifications in the approaches required to meet the patient’s goals.</text> </paragraph> <paragraph num="(6)"> <text>“Patient plan of care” means a written plan that includes all of the care, services, and treatment interventions the interdisciplinary team decides to implement to meet the specific needs of the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>A kidney dialysis center shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>An applicant shall obtain Medicare certification as a condition of licensure for a kidney dialysis center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedure."> <text>A kidney dialysis center shall submit a nonrefundable fee of $700 with an application for initial licensure or $700 with an application for license renewal.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Administration."> <paragraph num="A."> <text>Governing Body. The governing body shall:</text> <paragraph num="(1)"> <text>Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and</text> </paragraph> <paragraph num="(2)"> <text>Develop a written organizational plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Administrator.</text> <paragraph num="(1)"> <text>Qualifications.</text> <paragraph num="(a)"> <text>The kidney dialysis center administrator, if not the chief executive officer, shall at a minimum:</text> <paragraph num="(i)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(ii)"> <text>Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation;</text> </paragraph> <paragraph num="(iii)"> <text>Have at least 1 year of dialysis experience; and</text> </paragraph> <paragraph num="(iv)"> <text>Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The administrator, if not the chief executive officer, shall have knowledge in:</text> <paragraph num="(i)"> <text>Infection control;</text> </paragraph> <paragraph num="(ii)"> <text>Principles of dialysis;</text> </paragraph> <paragraph num="(iii)"> <text>Water treatment;</text> </paragraph> <paragraph num="(iv)"> <text>Reuse;</text> </paragraph> <paragraph num="(v)"> <text>Data collection and quality assurance;</text> </paragraph> <paragraph num="(vi)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(vii)"> <text>Fiscal operations, including business management and personnel;</text> </paragraph> <paragraph num="(viii)"> <text>Regulations; and</text> </paragraph> <paragraph num="(ix)"> <text>Policies and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Duties.</text> <paragraph num="(a)"> <text>The administrator shall be on site or available on call.</text> </paragraph> <paragraph num="(b)"> <text>The administrator shall have overall responsibility for:</text> <paragraph num="(i)"> <text>Implementing the facility's policies and coordinating the provision of services that the facility provides;</text> </paragraph> <paragraph num="(ii)"> <text>Organizing and coordinating the administrative functions of the facility;</text> </paragraph> <paragraph num="(iii)"> <text>Establishing procedures for the accountability of those personnel involved in patient care;</text> </paragraph> <paragraph num="(iv)"> <text>Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="(v)"> <text>Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters;</text> </paragraph> <paragraph num="(vi)"> <text>Participating in the development of organizational and fiscal planning for the facility;</text> </paragraph> <paragraph num="(vii)"> <text>Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and</text> </paragraph> <paragraph num="(viii)"> <text>Informing patients of the availability of emergency services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Waiver of Requirements for Administrator.</text> <paragraph num="(a)"> <text>The Department may grant a kidney dialysis center a waiver, with or without conditions, for a center that operates an administrator-in-training program.</text> </paragraph> <paragraph num="(b)"> <text>A center with an administrator-in-training program shall submit to the Department the:</text> <paragraph num="(i)"> <text>Administrator-in-training curriculum, including course outline and supporting materials;</text> </paragraph> <paragraph num="(ii)"> <text>Center's requirements for individuals who are selected to participate in the administrator-in-training program; and</text> </paragraph> <paragraph num="(iii)"> <text>Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may:</text> <paragraph num="(i)"> <text>Inspect the kidney dialysis center; or</text> </paragraph> <paragraph num="(ii)"> <text>Confer with the governing body.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Grant or Denial of Waiver. The Department may grant a waiver request if it determines that:</text> <paragraph num="(i)"> <text>The administrator-in-training program sufficiently meets the requirements of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>A waiver will not adversely affect patients.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If the Department determines that the conditions of §B(3)(d) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.</text> </paragraph> <paragraph num="(f)"> <text>Written Decision.</text> <paragraph num="(i)"> <text>The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request.</text> </paragraph> <paragraph num="(ii)"> <text>If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed.</text> </paragraph> <paragraph num="(h)"> <text>Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Policies and Procedures.</text> <paragraph num="(1)"> <text>The administrator, in consultation with the governing body, shall develop and implement policies and procedures governing the operation of the facility, which includes at a minimum those items in COMAR 10.05.01.06D and the following:</text> <paragraph num="(a)"> <text>The provision of dialysis and other end-stage renal disease services;</text> </paragraph> <paragraph num="(b)"> <text>The reuse of dialysis supplies including hemodialyzers and blood tubing, if reuse of supplies is practiced by the facility;</text> </paragraph> <paragraph num="(c)"> <text>Implementing and evaluating the patient care plan and the long-term care program for each patient; and</text> </paragraph> <paragraph num="(d)"> <text>Informing patients of the availability of emergency services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The administrator shall ensure that all:</text> <paragraph num="(a)"> <text>Policies and procedures are:</text> <paragraph num="(i)"> <text>Reviewed by staff at least annually and are revised as necessary; and</text> </paragraph> <paragraph num="(ii)"> <text>Available at all times for staff inspection and use; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Appropriate personnel implement all policies and procedures adopted.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Assurance Program."> <paragraph num="A."> <text>The Administrator shall ensure that the kidney dialysis center has a quality assurance program as required under COMAR 10.05.01.08.</text> </paragraph> <paragraph num="B."> <text>The quality assurance team shall document information regarding the quality assurance activities in accordance with COMAR 10.05.01.08F and provide a report to the administrator.</text> </paragraph> <paragraph num="C."> <text>The administrator shall:</text> <paragraph num="(1)"> <text>Review the report specified in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Implement any necessary corrective actions; and</text> </paragraph> <paragraph num="(3)"> <text>Notify the quality assurance team when corrective actions have been implemented.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Personnel."> <paragraph num="A."> <text>Medical Director.</text> <paragraph num="(1)"> <text>The medical director shall:</text> <paragraph num="(a)"> <text>Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis;</text> </paragraph> <paragraph num="(b)"> <text>Be responsible for the development of patient care policies; and</text> </paragraph> <paragraph num="(c)"> <text>Provide medical guidance in the provision of patient care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician with the same qualifications of the medical director as specified in §A(1)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Charge Nurse. The charge nurse shall be a registered nurse with training in the provision of kidney dialysis services and at least 6 months experience in a dialysis center.</text> </paragraph> <paragraph num="C."> <text>Dialysis Monitoring.</text> <paragraph num="(1)"> <text>Staffing Ratio.</text> <paragraph num="(a)"> <text>In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be:</text> <paragraph num="(i)"> <text>A minimum of one staff member to three participants; and</text> </paragraph> <paragraph num="(ii)"> <text>Sufficient to meet the needs of patients.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In-Center Nocturnal Hemodialysis. When in-center nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis shall be:</text> <paragraph num="(i)"> <text>A minimum of one staff member to five participants; and</text> </paragraph> <paragraph num="(ii)"> <text>Sufficient to meet the needs of the patients.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.</text> </paragraph> <paragraph num="(d)"> <text>The charge nurse may not be included in the staffing ratio except:</text> <paragraph num="(i)"> <text>When there are nine or fewer patients; or</text> </paragraph> <paragraph num="(ii)"> <text>In the event of an emergency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Staffing Exception Reporting.</text> <paragraph num="(a)"> <text>The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:</text> <paragraph num="(i)"> <text>The date and shift of the exception;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the emergency staffing situation;</text> </paragraph> <paragraph num="(iii)"> <text>Actions taken in response; and</text> </paragraph> <paragraph num="(iv)"> <text>Any measures taken to ensure the center's future compliance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The exception reporting protocol shall be included in the center's quality assurance process.</text> </paragraph> <paragraph num="(c)"> <text>The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitoring individuals shall be trained in dialysis procedures and may be a:</text> <paragraph num="(a)"> <text>Physician;</text> </paragraph> <paragraph num="(b)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(c)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(d)"> <text>Licensed practical nurse; or</text> </paragraph> <paragraph num="(e)"> <text>Certified nursing assistant — dialysis technician.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The kidney dialysis center shall also provide dietetic and social work services and consultation by individuals with experience or training in caring for dialysis and transplant patients sufficient to meet the needs of patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Affiliations."> <text>In addition to the requirements in 42 CFR §405.2136(e), as amended, which is incorporated by reference, for affiliations, the facility shall provide, make referrals, or have access to a certified home dialysis training program.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Patient Long-Term Program."> <paragraph num="A."> <text>The facility’s interdisciplinary team shall develop and maintain an individualized interdisciplinary comprehensive assessment for each patient to ensure that each patient receives the appropriate treatment modality, whether dialysis or transplantation.</text> </paragraph> <paragraph num="B."> <text>Patient Comprehensive Assessment. The patient’s comprehensive assessment shall be developed by a multidisciplinary team.</text> </paragraph> <paragraph num="C."> <text>The health care team described in §B of this regulation shall review, document, and make appropriate revisions to each patient's comprehensive assessment at least every 12 months or more often as indicated by the patient's response to treatment.</text> </paragraph> <paragraph num="D."> <text>When a patient is transferred to another kidney dialysis center, the facility shall ensure that a copy of the patient's comprehensive assessment accompanies the patient, or is sent to the new kidney dialysis center within 1 working day after transfer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Patient Care Plan."> <paragraph num="A."> <text>Patient Care Plan. A health care team, consisting of at least the physician, nurse practitioner, or physician assistant responsible for the patient's end-stage renal disease care, a nurse responsible for nursing services, a social worker, and a dietitian, shall develop an individualized care plan for each patient.</text> </paragraph> <paragraph num="B."> <text>The patient or health care decision maker shall be involved in developing the care plan.</text> </paragraph> <paragraph num="C."> <text>The health care team shall review the patient care plan:</text> <paragraph num="(1)"> <text>At least monthly for a patient whose condition has not stabilized, as determined by a physician's assessment of the patient's laboratory values and physical condition; or</text> </paragraph> <paragraph num="(2)"> <text>Annually for a patient whose condition has stabilized.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The health care team shall revise the patient care plan as necessary to ensure that it meets the patient's ongoing needs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Dialyzer Reuse."> <paragraph num="A."> <text>Patient Information.</text> <paragraph num="(1)"> <text>The kidney dialysis center shall:</text> <paragraph num="(a)"> <text>Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for home dialysis; and</text> </paragraph> <paragraph num="(b)"> <text>Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The signed informed consent form shall be maintained in the patient's medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards. If the kidney dialysis center reuses dialysis supplies, the medical director shall:</text> <paragraph num="(1)"> <text>Develop a dialysis reuse policy in accordance with 42 CFR §§405.2139(a), 405.2140(a)(5), (b), and (c), and 405.2150, which are incorporated by reference; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure compliance with the policy.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Physical Plant."> <paragraph num="A."> <text>Floor Space.</text> <paragraph num="(1)"> <text>The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station.</text> </paragraph> <paragraph num="(2)"> <text>Floor space may include bed or chair space, nursing space, and work area, but excludes storage space.</text> </paragraph> <paragraph num="(3)"> <text>At least 20 square feet of the patient station floor space shall be available on the side of the patient to be occupied by the dialysis assembly.</text> </paragraph> <paragraph num="(4)"> <text>Arrangement of space shall be sufficiently flexible to provide access to any of the patient's four extremities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Treatment Area.</text> <paragraph num="(1)"> <text>The treatment area shall be designed and equipped to:</text> <paragraph num="(a)"> <text>Provide privacy and comfort for patients;</text> </paragraph> <paragraph num="(b)"> <text>Facilitate staff monitoring of patients receiving dialysis services; and</text> </paragraph> <paragraph num="(c)"> <text>Provide for the adequate isolation of hepatitis-positive patients.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The kidney dialysis center shall have sufficient space for maintenance and storage of equipment and supplies, and for preparing and testing dialyzers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Water Standards."> <paragraph num="A."> <text>The kidney dialysis center shall:</text> <paragraph num="(1)"> <text>Comply with 42 CFR §405.2140(a)(5), as amended, which is incorporated by reference; and</text> </paragraph> <paragraph num="(2)"> <text>Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Water Treatment System Safeguards.</text> <paragraph num="(1)"> <text>The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including:</text> <paragraph num="(a)"> <text>Appropriate prefiltration for particulate matter;</text> </paragraph> <paragraph num="(b)"> <text>Reverse osmosis monitored by resistivity or conductivity, or an equivalent method, or both; or</text> </paragraph> <paragraph num="(c)"> <text>A mixed-resin bed deionizer with a one megohm monitors light, or an equivalent method.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prefiltration shall be followed by charcoal filtration before reverse osmosis, or deionization, or both.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The kidney dialysis center shall monitor microbial levels described in §B(1) of this regulation on a monthly basis.</text> </paragraph> <paragraph num="D."> <text>The kidney dialysis center shall maintain a log of water treatment system function and monitor the values on each occasion the machine is operated.</text> </paragraph> <paragraph num="E."> <text>The kidney dialysis center shall record in a log system malfunctions or temporary failures to meet standards.</text> </paragraph> <paragraph num="F."> <text>The kidney dialysis center shall report any system malfunction greater than 1 working day's duration, within 24 hours of discovery of the malfunction, to:</text> <paragraph num="(1)"> <text>The Office of Health Care Quality;</text> </paragraph> <paragraph num="(2)"> <text>The supplier as to the unprotected state of the dialysis facility; and</text> </paragraph> <paragraph num="(3)"> <text>The Commission on Kidney Disease.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the kidney dialysis center experiences a water system failure that may threaten patient health or safety, the center shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §405.2140(d), as amended which, is incorporated by reference.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="In-Center Nocturnal Hemodialysis."> <text>Before performing in-center nocturnal hemodialysis, the facility’s interdisciplinary team shall:</text> <paragraph num="A."> <text>Determine the patient’s appropriateness for in-center nocturnal hemodialysis by considering the patient’s:</text> <paragraph num="(1)"> <text>Overall medical condition;</text> </paragraph> <paragraph num="(2)"> <text>Expectations for care;</text> </paragraph> <paragraph num="(3)"> <text>Response to in-center day-time hemodialysis; and</text> </paragraph> <paragraph num="(4)"> <text>Availability of transportation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Document the patient’s appropriateness for in-center nocturnal hemodialysis in the patient’s medical record; and</text> </paragraph> <paragraph num="C."> <text>Obtain an order from a physician, nurse practitioner, or physician assistant for in-center nocturnal hemodialysis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Emergency Management."> <paragraph num="A."> <text>A kidney dialysis center shall have an emergency plan.</text> </paragraph> <paragraph num="B."> <text>An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address:</text> <paragraph num="(1)"> <text>The safe management of individuals who are receiving services at the kidney dialysis center when an emergency occurs;</text> </paragraph> <paragraph num="(2)"> <text>Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis center;</text> </paragraph> <paragraph num="(3)"> <text>Staff coverage, organization, and assignment of responsibilities; and</text> </paragraph> <paragraph num="(4)"> <text>The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This regulation does not prohibit a kidney dialysis center from applying for and receiving reimbursement:</text> <paragraph num="(1)"> <text>Under any applicable insurance policy; or</text> </paragraph> <paragraph num="(2)"> <text>From any State or federal funds that may be available due to a declared State or federal emergency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A kidney dialysis center is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation.</text> </paragraph> <paragraph num="E."> <text>For purposes of coordinating local emergency planning efforts, a kidney dialysis center shall provide access to the emergency plan developed under this regulation to local organizations for emergency management.</text> </paragraph> <paragraph num="F."> <text>A dialysis provider shall provide the Office of Health Care Quality a 24/7 live operational contact phone number.</text> </paragraph> <paragraph num="G."> <text>Information Regarding the Status of Generators. A kidney dialysis center shall provide one of the following regarding the status of generators:</text> <paragraph num="(1)"> <text>Evidence of an on-site generator;</text> </paragraph> <paragraph num="(2)"> <text>The capacity to hook up a generator; or</text> </paragraph> <paragraph num="(3)"> <text>A copy of the contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the center has no plan to use the services of a generator, the center shall provide a copy of the center's emergency plan to the Office of Health Care Quality that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 7, 2000 (27:2 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 17, 2008 (35:23 Md. R. 2013)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 18, 2013 (40:3 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective February 18, 2013 (40:3 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 18, 2013 (40:3 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, C amended effective February 18, 2013 (40:3 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective February 18, 2013 (40:3 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective February 18, 2013 (40:3 Md. R. 217)</annotation> </annotations> </chapter> <chapter num="05" heading="Freestanding Ambulatory Surgical Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Allied health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services, except those individuals who are licensed to practice medicine, dentistry, or podiatry under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Freestanding Ambulatory Surgical Facility.</text> <paragraph num="(a)"> <text>“Freestanding ambulatory surgical facility” means a facility, service, office facility, or other entity that:</text> <paragraph num="(i)"> <text>Operates exclusively for the purpose of providing surgical services to patients requiring a period of postoperative observation but not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following admission; and</text> </paragraph> <paragraph num="(ii)"> <text>Seeks reimbursement from payors as a freestanding ambulatory surgical facility.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Freestanding ambulatory surgical facility” does not include:</text> <paragraph num="(i)"> <text>The office of one or more health care practitioners seeking only professional reimbursement for the provision of medical services unless the office operates under contract or other agreement with a payor as a freestanding ambulatory surgical facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive ambulatory surgical referrals in accordance with utilization review or other policies adopted by a payor;</text> </paragraph> <paragraph num="(ii)"> <text>A facility or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>The office of a health care practitioner with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by the health care practitioner for patients of the health care practitioner;</text> </paragraph> <paragraph num="(iv)"> <text>The office of a group of health care practitioners with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by members of the group practice for patients of the group practice; or</text> </paragraph> <paragraph num="(v)"> <text>An office owned or operated by one or more dentists licensed under the Health Occupations Article, Annotated Code of Maryland, for the sole purpose of practicing dentistry.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Freestanding Endoscopy Facility.</text> <paragraph num="(a)"> <text>“Freestanding endoscopy facility” means a facility:</text> <paragraph num="(i)"> <text>For the testing, diagnosis, or treatment of a medical disorder in conjunction with the use of microscopic, endoscopic, or laparoscopic equipment that is inserted in a naturally occurring orifice of the body; and</text> </paragraph> <paragraph num="(ii)"> <text>That seeks reimbursement as a freestanding endoscopy facility from third-party payors.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Freestanding endoscopy facility” does not include:</text> <paragraph num="(i)"> <text>The office of one or more health care practitioners unless the office operates under a contract or other agreement with a payor as a freestanding endoscopy facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive endoscopic referrals in accordance with utilization review or other policies adopted by a payor; or</text> </paragraph> <paragraph num="(ii)"> <text>A facility or service operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Payor” means:</text> <paragraph num="(a)"> <text>A health insurer, nonprofit health service plan, or health maintenance organization that holds a certificate of authority to offer health insurance policies or contracts in this State in accordance with Health-General Article, Title 19, Subtitle 7, and the Insurance Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A third-party administrator or any other entity, under contract with a Maryland business to administer health benefits; or</text> </paragraph> <paragraph num="(c)"> <text>A self-insured group.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Surgery.</text> <paragraph num="(a)"> <text>“Surgery” means a procedure conducted for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine.</text> </paragraph> <paragraph num="(b)"> <text>“Surgery” includes:</text> <paragraph num="(i)"> <text>The diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include, lasers, ultrasound, ionizing radiation, scalpels, probes, and needles;</text> </paragraph> <paragraph num="(ii)"> <text>Cut, burned, vaporized, frozen, sutured, probed, or manipulated tissue by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means; or</text> </paragraph> <paragraph num="(iii)"> <text>Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Surgical services” means surgical procedures performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ambulatory surgical center in accordance with approved policies and procedures of the ambulatory surgical center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>A freestanding ambulatory surgical facility shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>An applicant shall obtain Medicare certification as a condition of licensure for a freestanding ambulatory surgical facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedure."> <text>In addition to meeting all of the requirements of COMAR 10.05.01.03A—C, the applicant shall submit a nonrefundable fee of $1,000 for a 3 year period, with an application for initial licensure, or submit a nonrefundable fee of $1,000 with an application for license renewal for a 3 year period.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Administration."> <text>The medical director shall develop protocols for the management of surgical patients and emergency situations. These protocols shall be available on site at all times for reference. The medical director shall review these protocols annually and make revisions as necessary.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Personnel."> <paragraph num="A."> <text>Credentialing of Physicians, Dentists, Podiatrists.</text> <paragraph num="(1)"> <text>As part of the formal written appointment process, the administrator, in consultation with the medical director, shall collect, review, and document the following information concerning a physician, dentist, or podiatrist licensed under the Health Occupations Article, Annotated Code of Maryland:</text> <paragraph num="(a)"> <text>The physician's, dentist's, or podiatrist's education;</text> </paragraph> <paragraph num="(b)"> <text>The professional experience of the physician, dentist, or podiatrist, including:</text> <paragraph num="(i)"> <text>Any board certification or specialty training of the physician, dentist, or podiatrist, and</text> </paragraph> <paragraph num="(ii)"> <text>Any post-graduate training;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist, including DEA registration;</text> </paragraph> <paragraph num="(d)"> <text>Whether any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist has been:</text> <paragraph num="(i)"> <text>Suspended, or</text> </paragraph> <paragraph num="(ii)"> <text>Revoked;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Any hospital where the physician, dentist, or podiatrist was appointed or employed during the last 10 years, including:</text> <paragraph num="(i)"> <text>The name of the hospital,</text> </paragraph> <paragraph num="(ii)"> <text>The term of appointment or employment, and</text> </paragraph> <paragraph num="(iii)"> <text>Privileges held and any disciplinary action taken, including suspension, revocation, limitation, or voluntary surrender;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The physician's, dentist's, or podiatrist's professional liability insurance for the last 5 years, including:</text> <paragraph num="(i)"> <text>The physician's, dentist's, or podiatrist's present carrier,</text> </paragraph> <paragraph num="(ii)"> <text>The physician's, dentist's, or podiatrist's current limits of coverage,</text> </paragraph> <paragraph num="(iii)"> <text>The physician's, dentist's, or podiatrist's current types of coverage, and</text> </paragraph> <paragraph num="(iv)"> <text>Restrictions on the physician's, dentist's, or podiatrist's coverage;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Any claim that has been made against the physician, dentist, or podiatrist in the practice of a health occupation in the last 5 years, and the status of the claim;</text> </paragraph> <paragraph num="(h)"> <text>Any physical or mental condition that currently impairs the physician's, dentist's, or podiatrist's ability to exercise privileges;</text> </paragraph> <paragraph num="(i)"> <text>Any complaint or report, permitted to be disclosed by law, which has been filed with any state licensing or disciplinary body, or comparable body of the armed forces; and</text> </paragraph> <paragraph num="(j)"> <text>Data provided by the National Practitioner Data Bank.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The administrator shall consider the delineation of services requested by each physician, dentist, or podiatrist and approve, deny, or modify the request as the administrator deems appropriate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For a physician, dentist, or podiatrist who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §A(1) of this regulation.</text> </paragraph> <paragraph num="C."> <text>The administrator shall establish a procedure for the biennial reappointment of each physician, dentist, or podiatrist. The procedures shall include an evaluation of the following for all physicians, dentists, or podiatrists:</text> <paragraph num="(1)"> <text>An update of the information required in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>An assessment of the physician's, dentist's, or podiatrist's performance pattern based on an analysis of:</text> <paragraph num="(a)"> <text>Complaints filed with the freestanding ambulatory surgical facility,</text> </paragraph> <paragraph num="(b)"> <text>Malpractice claims filed,</text> </paragraph> <paragraph num="(c)"> <text>Utilization, quality, and risk data,</text> </paragraph> <paragraph num="(d)"> <text>Adherence to policies, bylaws, and procedures, and</text> </paragraph> <paragraph num="(e)"> <text>Physician, dentist, or podiatrist practice patterns as reviewed through the freestanding ambulatory surgical facility's quality assurance program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Credentialing of Allied Health Professionals.</text> <paragraph num="(1)"> <text>Direct Hires.</text> <paragraph num="(a)"> <text>The Administrator, in consultation with the medical director, shall collect, review, and verify evidence of the following information for all licensed or certified allied health professionals that are employed by the freestanding ambulatory surgical facility:</text> <paragraph num="(i)"> <text>A current license or certificate to practice in this State; and</text> </paragraph> <paragraph num="(ii)"> <text>Malpractice insurance, if required by the facility.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The administrator shall approve the delineation of services to be provided by each allied health professional.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nondirect Hires. When a licensed physician, dentist, or podiatrist uses an allied health practitioner to provide services at the freestanding ambulatory surgical facility, and that person is not employed by the facility, the licensed physician, dentist, or podiatrist who employs the allied health practitioner is responsible for verifying the information required in §D(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Medical Director.</text> <paragraph num="(1)"> <text>The freestanding ambulatory surgical facility shall have a medical director who:</text> <paragraph num="(a)"> <text>Is responsible for the overall medical care that is provided by the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Advises and consults with the staff of the facility on all medical issues relating to services provided by the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The medical director shall be a physician, dentist, or podiatrist licensed to practice in the general areas for which the freestanding ambulatory surgical facility provides services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Surgical Services."> <paragraph num="A."> <text>Surgical procedures shall be performed in a safe manner by qualified physicians, dentists, or podiatrists who have been granted clinical privileges by the administrator.</text> </paragraph> <paragraph num="B."> <text>The administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical services including but not limited to:</text> <paragraph num="(1)"> <text>Personnel;</text> </paragraph> <paragraph num="(2)"> <text>Pre-operative testing and examinations;</text> </paragraph> <paragraph num="(3)"> <text>Surgical procedures;</text> </paragraph> <paragraph num="(4)"> <text>Post-anesthesia care and observation;</text> </paragraph> <paragraph num="(5)"> <text>Discharge planning;</text> </paragraph> <paragraph num="(6)"> <text>Emergency services;</text> </paragraph> <paragraph num="(7)"> <text>Informed consent; and</text> </paragraph> <paragraph num="(8)"> <text>Safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before conducting a surgical procedure, a physician or other qualified health care practitioner shall conduct a history and physical examination.</text> </paragraph> <paragraph num="D."> <text>If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a qualified anesthetist shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient.</text> </paragraph> <paragraph num="E."> <text>If the assessments required by §§C and D of this regulation are performed before the day of surgery, a qualified health care practitioner shall on the day of surgery reassess and document any change in the patient's clinical status that could have an effect on the surgical procedure to be performed and the anesthesia to be used.</text> </paragraph> <paragraph num="F."> <text>Discharge.</text> <paragraph num="(1)"> <text>Before discharge from the facility, the anesthetist or, if local anesthesia is administered, the physician, dentist, or podiatrist who performed the surgery shall evaluate each patient for proper anesthesia recovery and document that evaluation.</text> </paragraph> <paragraph num="(2)"> <text>The physician, dentist, podiatrist, or anesthesiologist shall discharge each patient from the facility to a responsible adult, except those patients for whom no supervision is required as determined by the health care practitioner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Anesthesia Services."> <paragraph num="A."> <text>Anesthetics shall be administered by health practitioners who are licensed, certified, or otherwise authorized to do so under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Anesthetics shall be administered only by a:</text> <paragraph num="(1)"> <text>Qualified anesthesiologist;</text> </paragraph> <paragraph num="(2)"> <text>Physician or dentist qualified to administer anesthesia;</text> </paragraph> <paragraph num="(3)"> <text>Certified registered nurse anesthetist in accordance with Health Occupations Article, §8-205, Annotated Code of Maryland, and COMAR 10.27.06; or</text> </paragraph> <paragraph num="(4)"> <text>Podiatrist in accordance with Health Occupations Article, §16-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Emergency Services."> <paragraph num="A."> <text>Basic Life Support. Licensed personnel employed by the freestanding ambulatory surgical facility shall have certification in basic life support. A licensed staff individual trained in basic life support shall be on duty whenever there is a patient in the facility.</text> </paragraph> <paragraph num="B."> <text>The licensee shall have:</text> <paragraph num="(1)"> <text>A registered nurse available on site for emergency treatment whenever there is a patient in the freestanding ambulatory surgical facility;</text> </paragraph> <paragraph num="(2)"> <text>At least one physician available by phone 24 hours a day to respond to emergency situations; and</text> </paragraph> <paragraph num="(3)"> <text>Formal arrangements to obtain radiology and laboratory services at all times in case of emergencies.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The freestanding ambulatory surgical facility shall have at least the following emergency equipment available to the operating rooms:</text> <paragraph num="(1)"> <text>Emergency call system;</text> </paragraph> <paragraph num="(2)"> <text>Oxygen;</text> </paragraph> <paragraph num="(3)"> <text>Mechanical ventilatory assistance including airways, manual breathing bag, and ventilator;</text> </paragraph> <paragraph num="(4)"> <text>Cardiac defibrillator;</text> </paragraph> <paragraph num="(5)"> <text>Cardiac monitoring equipment;</text> </paragraph> <paragraph num="(6)"> <text>Tracheostomy set;</text> </paragraph> <paragraph num="(7)"> <text>Laryngoscopes and endotracheal tubes;</text> </paragraph> <paragraph num="(8)"> <text>Suction equipment; and</text> </paragraph> <paragraph num="(9)"> <text>Emergency medical equipment and supplies specified by the medical staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Hospitalization."> <paragraph num="A."> <text>The freestanding ambulatory surgical facility shall have an effective procedure for the transfer of patients to a hospital when care beyond the capabilities of the facility is required.</text> </paragraph> <paragraph num="B."> <text>Procedures for emergency transfer to a hospital shall include, at a minimum:</text> <paragraph num="(1)"> <text>Having a written transfer agreement with a local Medicare participating hospital or requiring all physicians, dentists, or podiatrists performing surgery in the freestanding ambulatory surgical facility to have admitting privileges at such a hospital;</text> </paragraph> <paragraph num="(2)"> <text>Having a mechanism for notifying the hospital of a pending emergency case;</text> </paragraph> <paragraph num="(3)"> <text>Having a mechanism for arranging appropriate transportation to the hospital; and</text> </paragraph> <paragraph num="(4)"> <text>The manner in which a facility sends a copy of the patient's medical record to the hospital.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Pharmaceutical Services."> <paragraph num="A."> <text>The freestanding ambulatory surgical facility shall:</text> <paragraph num="(1)"> <text>Provide drugs and biologicals under the direction of an authorized prescriber; and</text> </paragraph> <paragraph num="(2)"> <text>Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Administration of Drugs.</text> <paragraph num="(1)"> <text>Staff shall prepare and administer drugs according to established policies and acceptable standards of practice.</text> </paragraph> <paragraph num="(2)"> <text>Staff shall report adverse reactions to the patient's health care practitioner and document these reactions in the patient's medical record.</text> </paragraph> <paragraph num="(3)"> <text>Only physicians or registered nurses shall administer blood and blood products.</text> </paragraph> <paragraph num="(4)"> <text>Orders given orally for drugs and biologicals shall be followed by a written order which is signed by the authorized prescriber.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Laboratory and Radiologic Services."> <paragraph num="A."> <text>The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiologic services to meet the needs of patients. Policies and procedures shall include:</text> <paragraph num="(1)"> <text>Turn-around time;</text> </paragraph> <paragraph num="(2)"> <text>Review of laboratory reports; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of laboratory results.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Laboratory facilities shall be approved under the Clinical Laboratory Improvement Act (CLIA) and be licensed by this State.</text> </paragraph> <paragraph num="C."> <text>The freestanding ambulatory surgical facility shall include laboratory and radiologic reports in the patient's medical records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Medical Records."> <paragraph num="A."> <text>The facility shall comply with COMAR 10.05.01.09 and the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>Each medical record shall include, at a minimum:</text> <paragraph num="(1)"> <text>Preoperative diagnostic studies, entered before surgery, if performed;</text> </paragraph> <paragraph num="(2)"> <text>Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those tissues exempted by the medical director;</text> </paragraph> <paragraph num="(3)"> <text>Any allergies and abnormal drug reactions; and</text> </paragraph> <paragraph num="(4)"> <text>Entries related to anesthesia administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Physical Environment."> <paragraph num="A."> <text>The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services.</text> </paragraph> <paragraph num="B."> <text>Each operating room shall be designed and equipped to ensure that surgical procedures conducted can be performed in a manner that ensures the safety of all individuals in the area.</text> </paragraph> <paragraph num="C."> <text>The facility shall have a separate recovery room and waiting area.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 23, 1999 (26:17 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 19, 2013 (40:16 Md. R. 1343); December 21, 2015 (42:25 Md. R. 1542)</annotation> </annotations> </chapter> </subtitle> <subtitle num="06" heading="Diseases"> <chapter num="01" heading="Communicable Diseases and Related Conditions of Public Health Importance"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter does not apply to human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) surveillance, reporting, record maintenance, or confidentiality, which are covered by COMAR 10.18.02 and 10.18.03.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) control.</text> </paragraph> <paragraph num="C."> <text>This chapter provides regulations for coordinated control efforts for communicable diseases and related conditions by the Department, local health officers, medical laboratory directors, physicians, veterinarians, and other Maryland governmental agencies, as guided by policy statements such as:</text> <paragraph num="(1)"> <text>Recommendations of the Centers for Disease Control and Prevention, such as those of the Advisory Committee on Immunization Practices and the Advisory Council for the Elimination of Tuberculosis;</text> </paragraph> <paragraph num="(2)"> <text>Recommendations of the National Association of State Public Health Veterinarians, including:</text> <paragraph num="(a)"> <text>The Compendium of Animal Rabies Prevention and Control, 2016;</text> </paragraph> <paragraph num="(b)"> <text>The Compendium of Measures to Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017; and</text> </paragraph> <paragraph num="(c)"> <text>The Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2017.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>Control of Communicable Diseases Manual (American Public Health Association, Twentieth Edition, 2015);</text> </paragraph> <paragraph num="B."> <text>Compendium of Measures to Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017 (The Association of Avian Veterinarians, 2017);</text> </paragraph> <paragraph num="C."> <text>Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2017 (The National Association of State Public Health Veterinarians, 2017); and</text> </paragraph> <paragraph num="D."> <text>Compendium of Animal Rabies Prevention and Control, 2016 (The National Association of State Public Health Veterinarians, 2016).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The definitions of terms used in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of diseases within this State under this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Body Fluid.</text> <paragraph num="(a)"> <text>“Body fluid” means an excretion or fluid from a human body that contains visible blood and all other tissues, excretions or fluids including:</text> <paragraph num="(i)"> <text>Visible blood or any body fluid that is visibly contaminated with blood;</text> </paragraph> <paragraph num="(ii)"> <text>Semen or vaginal secretions;</text> </paragraph> <paragraph num="(iii)"> <text>Amniotic, cerebrospinal, pericardial, peritoneal, pleural, or synovial fluids;</text> </paragraph> <paragraph num="(iv)"> <text>Saliva in dental procedures; and</text> </paragraph> <paragraph num="(v)"> <text>All body fluids in situations where it is difficult or impossible to differentiate between body fluids.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Body fluid” does not include stool, nasal secretions, sputum, tears, urine, or vomitus.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Case” means an individual who has laboratory or clinical evidence of being infected by an infectious agent.</text> </paragraph> <paragraph num="(3)"> <text>“Case of a condition” means an individual who suffers from a condition that is not caused by an infectious agent, including, but not limited to:</text> <paragraph num="(a)"> <text>An animal bite;</text> </paragraph> <paragraph num="(b)"> <text>An adverse reaction to pertussis vaccine;</text> </paragraph> <paragraph num="(c)"> <text>Harmful algal bloom related illness;</text> </paragraph> <paragraph num="(d)"> <text>Pesticide related illness; or</text> </paragraph> <paragraph num="(e)"> <text>Ricin toxin poisoning.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Case (or suspected case) of avian psittacosis” means that a bird has:</text> <paragraph num="(a)"> <text>Laboratory evidence of Chlamydophila psittaci infection consisting of:</text> <paragraph num="(i)"> <text>Culture isolation of Chlamydophila psittaci from a clinical specimen;</text> </paragraph> <paragraph num="(ii)"> <text>A positive fluorescent antibody test for Chlamydophila psittaci on a clinical specimen;</text> </paragraph> <paragraph num="(iii)"> <text>A fourfold, or greater, increase in Chlamydophila psittaci antibody in a serologic titer, in two serum specimens obtained at least 2 weeks apart and assayed simultaneously at the same laboratory; or</text> </paragraph> <paragraph num="(iv)"> <text>Identification of Chlamydophila psittaci within macrophages in smears stained with Gimenez or Macchiavellos stain or sections of the bird's tissues; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Clinical evidence of Chlamydophila psittaci infection consisting of an epidemiologic link to an avian case that has laboratory evidence of infection, and has:</text> <paragraph num="(i)"> <text>Exhibited one or more signs of psittacosis;</text> </paragraph> <paragraph num="(ii)"> <text>Died;</text> </paragraph> <paragraph num="(iii)"> <text>Been clinically diagnosed as having psittacosis by a licensed veterinarian; or</text> </paragraph> <paragraph num="(iv)"> <text>Had gross necropsy findings or histopathological evidence consistent with psittacosis as reported by a veterinary pathologist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Child Care Facility.</text> <paragraph num="(a)"> <text>“Child care facility” means a licensed, registered, or unlicensed facility, institution, establishment, or home where children receive care or supervision for which money is paid when the child's parent has given the child's care over to another on a regular basis for some portion of a 24-hour day as a supplement to the parent's primary care of the child.</text> </paragraph> <paragraph num="(b)"> <text>“Child care facility” includes child care center, day care center, nursery, family day care home, and babysitter.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Clinical Material.</text> <paragraph num="(a)"> <text>“Clinical material” means:</text> <paragraph num="(i)"> <text>An organism isolated from a clinical specimen;</text> </paragraph> <paragraph num="(ii)"> <text>Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or</text> </paragraph> <paragraph num="(iii)"> <text>If the organism or material described in §B(6)(a)(i) and (ii) of this regulation is not available, material from an individual that has already been obtained by the medical laboratory, in the following order of preference: a patient specimen, microbial genetic material, or other laboratory material.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Clinical material” includes, for Mycobacterium tuberculosis, one culture obtained from the primary isolate on which the diagnosis of tuberculosis was established.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Colonization” means the proliferation of microorganisms on or within one or more body sites without detectable host immune response, cellular damage, or clinical expression.</text> </paragraph> <paragraph num="(8)"> <text>“Commissioner” means the Commissioner of Health of the Baltimore City Health Department.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Foodborne disease outbreak” means two or more epidemiologically related cases of illness following consumption of a common food item or items, or one case of botulism, cholera, mushroom poisoning, trichinosis, or fish poisoning such as ciguatera poisoning, scombroid poisoning, paralytic shellfish poisoning, and other neurotoxic shellfish poisoning.</text> </paragraph> <paragraph num="(11)"> <text>“Health care provider” includes, but is not limited to:</text> <paragraph num="(a)"> <text>Physicians;</text> </paragraph> <paragraph num="(b)"> <text>Physician assistants;</text> </paragraph> <paragraph num="(c)"> <text>Dentists;</text> </paragraph> <paragraph num="(d)"> <text>Chiropractors;</text> </paragraph> <paragraph num="(e)"> <text>Nurse practitioners;</text> </paragraph> <paragraph num="(f)"> <text>Nurses;</text> </paragraph> <paragraph num="(g)"> <text>Podiatrists;</text> </paragraph> <paragraph num="(h)"> <text>Medical examiners;</text> </paragraph> <paragraph num="(i)"> <text>Hospital administrators;</text> </paragraph> <paragraph num="(j)"> <text>Clinic administrators;</text> </paragraph> <paragraph num="(k)"> <text>Dispensary administrators;</text> </paragraph> <paragraph num="(l)"> <text>Nursing home administrators; and</text> </paragraph> <paragraph num="(m)"> <text>Any other licensed health care providers.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Health Care Worker.</text> <paragraph num="(a)"> <text>“Health care worker” means a paid or unpaid individual working in a health care setting who has the potential for exposure to:</text> <paragraph num="(i)"> <text>Infectious materials, including body substances;</text> </paragraph> <paragraph num="(ii)"> <text>Contaminated medical supplies and equipment;</text> </paragraph> <paragraph num="(iii)"> <text>Contaminated environmental surfaces; or</text> </paragraph> <paragraph num="(iv)"> <text>Contaminated air.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care worker” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Emergency medical service personnel;</text> </paragraph> <paragraph num="(ii)"> <text>Dental personnel;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory personnel;</text> </paragraph> <paragraph num="(iv)"> <text>Autopsy personnel;</text> </paragraph> <paragraph num="(v)"> <text>Nurses;</text> </paragraph> <paragraph num="(vi)"> <text>Nursing assistants;</text> </paragraph> <paragraph num="(vii)"> <text>Physicians;</text> </paragraph> <paragraph num="(viii)"> <text>Physician assistants;</text> </paragraph> <paragraph num="(ix)"> <text>Technicians;</text> </paragraph> <paragraph num="(x)"> <text>Therapists;</text> </paragraph> <paragraph num="(xi)"> <text>Pharmacists;</text> </paragraph> <paragraph num="(xii)"> <text>Students and trainees;</text> </paragraph> <paragraph num="(xiii)"> <text>Contractual staff not employed by the health care facility; and</text> </paragraph> <paragraph num="(xiv)"> <text>Individuals not directly involved in patient care but potentially exposed to infectious agents, for example, clerical, dietary, housekeeping, maintenance, and volunteer personnel.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City, or the duly designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(14)"> <text>“Infectious” means capable of being transmitted in a manner that can cause a disease or abnormal condition in an individual.</text> </paragraph> <paragraph num="(15)"> <text>“Invasive disease” means a disease in which an organism is detected in a specimen taken from a normally sterile body site.</text> </paragraph> <paragraph num="(16)"> <text>“Normally sterile body site” means a body site except for skin, external ear, oronasopharynx, gastrointestinal tract, urethral meatus, and vagina.</text> </paragraph> <paragraph num="(17)"> <text>“Novel influenza A virus infection” means a human case of infection with an influenza A virus subtype that is suspected to be markedly different from currently circulating human influenza A viruses, including, but not limited to, H2, H5, H7, or H9 subtypes.</text> </paragraph> <paragraph num="(18)"> <text>“Outbreak” means:</text> <paragraph num="(a)"> <text>A foodborne disease outbreak;</text> </paragraph> <paragraph num="(b)"> <text>Three or more cases of a disease or illness that is not a foodborne outbreak and that occurs in individuals who are not living in the same household, but who are epidemiologically linked;</text> </paragraph> <paragraph num="(c)"> <text>An increase in the number of infections in a facility, such as a hospital, long-term care facility, assisted living facility, school, or child care center, over the baseline rate usually found in that facility;</text> </paragraph> <paragraph num="(d)"> <text>A situation designated by the Secretary as an outbreak; or</text> </paragraph> <paragraph num="(e)"> <text>One case of:</text> <paragraph num="(i)"> <text>Anthrax;</text> </paragraph> <paragraph num="(ii)"> <text>Botulism;</text> </paragraph> <paragraph num="(iii)"> <text>Cholera (imported or seafood related);</text> </paragraph> <paragraph num="(iv)"> <text>Ciguatera poisoning;</text> </paragraph> <paragraph num="(v)"> <text>Mushroom poisoning;</text> </paragraph> <paragraph num="(vi)"> <text>Paralytic shellfish poisoning and other neurotoxic shellfish poisoning;</text> </paragraph> <paragraph num="(vii)"> <text>Plague;</text> </paragraph> <paragraph num="(viii)"> <text>Rabies (human);</text> </paragraph> <paragraph num="(ix)"> <text>Smallpox;</text> </paragraph> <paragraph num="(x)"> <text>Scombroid poisoning; or</text> </paragraph> <paragraph num="(xi)"> <text>Trichinosis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>Pet Animal.</text> <paragraph num="(a)"> <text>“Pet animal” means a live animal sold or distributed to the public with or without charge for pleasure or companionship and not for utility.</text> </paragraph> <paragraph num="(b)"> <text>“Pet animal” does not include domestic farm animals including, but not limited to:</text> <paragraph num="(i)"> <text>Equids;</text> </paragraph> <paragraph num="(ii)"> <text>Cattle;</text> </paragraph> <paragraph num="(iii)"> <text>Goats;</text> </paragraph> <paragraph num="(iv)"> <text>Sheep; and</text> </paragraph> <paragraph num="(v)"> <text>Swine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>Pet Store.</text> <paragraph num="(a)"> <text>“Pet store” means a facility that keeps, cares for, and houses animals classified as pet animals for the purpose of sale or distribution to the public.</text> </paragraph> <paragraph num="(b)"> <text>“Pet store” includes but is not limited to a:</text> <paragraph num="(i)"> <text>Commercial facility;</text> </paragraph> <paragraph num="(ii)"> <text>Feed store; or</text> </paragraph> <paragraph num="(iii)"> <text>Department store.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Physician” means an individual licensed to practice osteopathy or medicine by the State, or the physician's designee working under the supervision of the physician.</text> </paragraph> <paragraph num="(22)"> <text>“Reptile” means a cold blooded, air breathing vertebrate of the class Reptilia.</text> </paragraph> <paragraph num="(23)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(24)"> <text>“Sell” means to sell, hold for sale, or offer for commercial or public distribution, a pet animal.</text> </paragraph> <paragraph num="(25)"> <text>“Seller” means a person who sells, holds for sale, or offers for commercial or public distribution, a pet animal.</text> </paragraph> <paragraph num="(26)"> <text>“Sexually transmitted infection” means an infection which may be spread by sexual intercourse, including oral, anal, or vaginal sexual contact with an infected individual.</text> </paragraph> <paragraph num="(27)"> <text>Skin-Penetrating Body Adornment Procedure.</text> <paragraph num="(a)"> <text>“Skin-penetrating body adornment procedure” means a process that involves piercing or entering the skin or the mucous membrane of an individual for the purpose of inserting pigmented patterns, jewelry, or other forms of body decoration.</text> </paragraph> <paragraph num="(b)"> <text>“Skin-penetrating body adornment procedure” includes body-piercing and tattooing.</text> </paragraph> <paragraph num="(c)"> <text>“Skin-penetrating body adornment procedure” does not include piercing of an earlobe using a properly disinfected ear-piercing gun and single-use sterile studs and clutches.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>Standard Precautions.</text> <paragraph num="(a)"> <text>“Standard precautions” means a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed diagnosis or presumed infection status, given that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents.</text> </paragraph> <paragraph num="(b)"> <text>“Standard precautions” includes:</text> <paragraph num="(i)"> <text>Hand hygiene and use of gloves, gown, mask, eye protection, or face shield depending on anticipated exposure; and</text> </paragraph> <paragraph num="(ii)"> <text>Handling equipment or items in the patient environment likely to have been contaminated with infectious fluids in a manner to prevent transmission of infectious agents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Turtle” means an animal commonly known as a turtle, tortoise, or terrapin.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reportable Diseases, Conditions, Outbreaks, and Unusual Manifestations; Submitting Clinical Materials."> <paragraph num="A."> <text>A person, as set forth in Regulation .04 of this chapter, shall report the diseases or conditions listed in §C of this regulation, or any other condition as requested by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Upon a positive laboratory finding for a disease or condition listed in §C of this regulation, or upon request of the Secretary, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall:</text> <paragraph num="(1)"> <text>Submit clinical material to the Department's public health laboratory; and</text> </paragraph> <paragraph num="(2)"> <text>Include information about the clinical material on a form provided by the Secretary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>List of Reportable Diseases and Conditions.</text> <paragraph num="1."> <text>As required to report in Regulation .04A(1)—(3), (5), and (6) of this chapter.</text> </paragraph> <paragraph num="2."> <text>The time frame for reporting is specified in Regulation .04C of this chapter.</text> </paragraph> <paragraph num="3."> <text>Clinical material shall be submitted according to §B of this regulation.</text> </paragraph> <paragraph num="4."> <text>Any grouping or clustering of patients having similar disease, symptoms, or syndromes that may indicate the presence of a disease outbreak.</text> </paragraph> <paragraph num="5."> <text>Suspected hepatitis C as indicated by:</text> <paragraph num="(a)"> <text>Any hepatitis C antibody results that are positive;</text> </paragraph> <paragraph num="(b)"> <text>Any hepatitis C virus RNA results associated with the results in(a) of this footnote that are qualitative or quantitative, if the results are:</text> <paragraph num="(i)"> <text>Positive; or</text> </paragraph> <paragraph num="(ii)"> <text>Negative; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Any hepatitis C virus RNA results associated with the results in(a) of this footnote if the hepatitis C virus is:</text> <paragraph num="(i)"> <text>Detected; or</text> </paragraph> <paragraph num="(ii)"> <text>Undetected.</text> </paragraph> </paragraph> </paragraph> <paragraph num="6."> <text>Acquired immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV), including CD4+ lymphocyte count and viral load, are reportable under COMAR 10.18.</text> </paragraph> <paragraph num="7."> <text>Suspected syphilis as indicated by:</text> <paragraph num="(a)"> <text>Any treponemal or non-treponemal results that are qualitative or quantitative, if the results are:</text> <paragraph num="(i)"> <text>Positive;</text> </paragraph> <paragraph num="(ii)"> <text>Reactive; or</text> </paragraph> <paragraph num="(iii)"> <text>Inconclusive; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any negative or non-reactive results associated with the positive, reactive, or inconclusive results in(a) of this footnote.</text> </paragraph> </paragraph> <paragraph num="8."> <text>Tuberculosis confirmed by culture and suspected tuberculosis as indicated by:</text> <paragraph num="(a)"> <text>A laboratory confirmed acid-fast bacillus on smear;</text> </paragraph> <paragraph num="(b)"> <text>An abnormal chest radiograph suggestive of active tuberculosis;</text> </paragraph> <paragraph num="(c)"> <text>A laboratory confirmed biopsy report consistent with active tuberculosis; or</text> </paragraph> <paragraph num="(d)"> <text>Initiation of two or more anti-tuberculosis medications.</text> </paragraph> </paragraph> <paragraph num="9."> <text>Latent tuberculosis infection as indicated when:</text> <paragraph num="(a)"> <text>There is a positive result on an Interferon Gamma Release Assay, Tuberculin Skin Test, or any other test indicating tuberculosis infection; and</text> </paragraph> <paragraph num="(b)"> <text>Active or suspected tuberculosis has been ruled out.</text> </paragraph> </paragraph> <paragraph num="10."> <text>Vibriosis, non-cholera, identified in any specimen taken from teeth, gingival tissues, or oral mucosa is not reportable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reporting Procedures."> <paragraph num="A."> <text>Sources of Reports and to Whom to Report.</text> <paragraph num="(1)"> <text>An institution, as specified in Health-General Article, §18-202, Annotated Code of Maryland, and a health care provider who knows of a case of a reportable disease, condition, outbreak, or unusual manifestation shall report it to a health officer.</text> </paragraph> <paragraph num="(2)"> <text>A teacher at any public, private, or parochial school or a child care provider at any child care facility shall report an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation as set forth in Regulation .03 of this chapter to the principal, school nurse, or superintendent or assistant superintendent or designee, who shall transmit to a health officer a report of the name and address of a child who appears to have a reportable communicable disease or who has been exposed to a reportable communicable disease.</text> </paragraph> <paragraph num="(3)"> <text>The master or person in charge of a vessel or aircraft within the territory of the State shall report to the Secretary or a health officer at the nearest port of landing or entry, all known facts relating to the illness and physical condition of an individual aboard the vessel or aircraft who may have a reportable disease or condition, an outbreak, or an unusual manifestation.</text> </paragraph> <paragraph num="(4)"> <text>Directors of Medical Laboratories or Laboratories that Possess Biological Agents as Defined in COMAR 10.10.11.03B(8).</text> <paragraph num="(a)"> <text>The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall report:</text> <paragraph num="(i)"> <text>Laboratory evidence of a reportable condition as specified in Regulation .03C of this chapter from examination of a human specimen acquired from an individual in this State; and</text> </paragraph> <paragraph num="(ii)"> <text>Evidence of any other condition as requested by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) located in a Maryland jurisdiction shall report to the health officer of that jurisdiction.</text> </paragraph> <paragraph num="(c)"> <text>The director of a medical laboratory located outside of Maryland shall report to the Secretary.</text> </paragraph> <paragraph num="(d)"> <text>If a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) forwards clinical materials out of State for testing, the originating medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall comply with this subsection by:</text> <paragraph num="(i)"> <text>Reporting the results and submitting the clinical materials; or</text> </paragraph> <paragraph num="(ii)"> <text>Ensuring that the results are reported and materials submitted.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>When more than one specimen is taken from a patient during one disease episode, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) need not report every test result of a specimen that shows evidence of the same disease in that patient if:</text> <paragraph num="(i)"> <text>At least one positive test result is reported; and</text> </paragraph> <paragraph num="(ii)"> <text>A health officer has agreed that all test reports do not need to be reported.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any individual having knowledge of an animal bite shall report the bite according to the requirements of COMAR 10.06.02.</text> </paragraph> <paragraph num="(6)"> <text>The owner or operator of a food establishment as defined in Health-General Article, §21-301, Annotated Code of Maryland, shall report to a health officer an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Method and Content of Reports.</text> <paragraph num="(1)"> <text>A person, as listed in §A(1)—(4) of this regulation, shall report:</text> <paragraph num="(a)"> <text>In writing on a form provided by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>In a format approved by the Secretary, when electronic submittal is available.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The report shall include at a minimum the:</text> <paragraph num="(a)"> <text>Date of the report;</text> </paragraph> <paragraph num="(b)"> <text>Patient's name including first and last names and middle initial;</text> </paragraph> <paragraph num="(c)"> <text>Residence address of the patient including:</text> <paragraph num="(i)"> <text>House or apartment number;</text> </paragraph> <paragraph num="(ii)"> <text>Street;</text> </paragraph> <paragraph num="(iii)"> <text>City or town;</text> </paragraph> <paragraph num="(iv)"> <text>State; and</text> </paragraph> <paragraph num="(v)"> <text>Zip code;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Telephone number including area code;</text> </paragraph> <paragraph num="(e)"> <text>Date of birth;</text> </paragraph> <paragraph num="(f)"> <text>Sex;</text> </paragraph> <paragraph num="(g)"> <text>Race;</text> </paragraph> <paragraph num="(h)"> <text>Ethnicity;</text> </paragraph> <paragraph num="(i)"> <text>Pregnancy status if applicable; and</text> </paragraph> <paragraph num="(j)"> <text>Other epidemiologic information as specified by the Secretary or the health officer.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to what is specified in §B(2) of this regulation, institutions and health care providers, school and child care facility personnel, and masters of vessels or aircraft as listed in §A(1)—(3) of this regulation shall report:</text> <paragraph num="(a)"> <text>The date of onset of symptoms;</text> </paragraph> <paragraph num="(b)"> <text>The diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>For syphilis, gonococcal infection, and Chlamydia trachomatis infection, the treatment given; and</text> </paragraph> <paragraph num="(d)"> <text>Any laboratory information supporting the diagnosis of the disease or condition, as requested.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A director of a medical laboratory, in addition to what is specified in §B(2) of this regulation, shall report the:</text> <paragraph num="(a)"> <text>Name, address, telephone number, and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number of the laboratory performing the test;</text> </paragraph> <paragraph num="(b)"> <text>Date the specimen was received by the laboratory;</text> </paragraph> <paragraph num="(c)"> <text>Accession number or other unique identifier for the specimen;</text> </paragraph> <paragraph num="(d)"> <text>Type of test performed and the results, including:</text> <paragraph num="(i)"> <text>Reference range;</text> </paragraph> <paragraph num="(ii)"> <text>Quantitative results; and</text> </paragraph> <paragraph num="(iii)"> <text>Results of speciating, grouping, or typing of organisms;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Date of specimen collection;</text> </paragraph> <paragraph num="(f)"> <text>Type of specimen, for example, blood, urine, stool, or mucus, and the site of specimen collection, for example, cervix, eye;</text> </paragraph> <paragraph num="(g)"> <text>Date of the laboratory result;</text> </paragraph> <paragraph num="(h)"> <text>Name, address including number and street, city, state, and zip code, and phone number including area code of the health care provider who ordered the test;</text> </paragraph> <paragraph num="(i)"> <text>Name, address including number and street, city, state, and zip code, and phone number including area code of the facility that ordered the test; and</text> </paragraph> <paragraph num="(j)"> <text>For hepatitis C infection:</text> <paragraph num="(i)"> <text>Signal-to-cut-off ratios and critical values;</text> </paragraph> <paragraph num="(ii)"> <text>Hepatitis A IgM results; and</text> </paragraph> <paragraph num="(iii)"> <text>Hepatitis B IgM test results.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Timing of Reports.</text> <paragraph num="(1)"> <text>If the Secretary requires an immediate report, the person making the report:</text> <paragraph num="(a)"> <text>Shall communicate directly with an individual in person or by telephone; and</text> </paragraph> <paragraph num="(b)"> <text>May not leave a message on an answering device.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health care provider and a director of a medical laboratory shall report according to the time frame in Regulation .03C of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>School and child care facility personnel, a master of a vessel or aircraft, and the owner or operator of a food establishment shall report immediately.</text> </paragraph> <paragraph num="(4)"> <text>A health officer shall transmit to the Secretary, by mail or as otherwise specified by the Secretary, all information obtained:</text> <paragraph num="(a)"> <text>Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Within a shorter amount of time than 24 hours as specified by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Secretary shall transmit to the health officer of the jurisdiction where the patient resides, by mail or as otherwise specified by the Secretary, all information related to the notice of a reportable condition provided by a director of a medical laboratory located outside of Maryland:</text> <paragraph num="(a)"> <text>Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Within a shorter amount of time than 24 hours as specified by the Secretary.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Record Maintenance and Confidentiality."> <paragraph num="A."> <text>The custodian of a report identifying an individual that was filed by a reporting source (Regulation .04A) in compliance with the provisions of Health-General Article, §§18-201, 18-202, and 18-205, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Shall keep the report and record confidential;</text> </paragraph> <paragraph num="(2)"> <text>May not open a report or record to public inspection;</text> </paragraph> <paragraph num="(3)"> <text>Shall release a report or record or respond to a subpoena for a report or record in criminal or civil proceeding only pursuant to court order sealing the record; and</text> </paragraph> <paragraph num="(4)"> <text>Shall make a record or report available to a governmental agency performing its lawful duties as authorized by an act of the Maryland General Assembly or the United States Congress when the Secretary determines that the release of information is necessary to protect the public health or to prevent the spread of an infectious or contagious disease.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A report identifying an individual that was filed by a reporting source, as set forth under Regulation .04A of this chapter, in compliance with the provisions of Health-General Article, §§18-201, 18-202, and 18-205, Annotated Code of Maryland, and all information collected in connection with a report, are not medical records under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Communication with a Health Care Provider or Patient.</text> <paragraph num="(1)"> <text>The Secretary or a health officer may discuss a laboratory report with the attending physician or other health care provider caring for a patient.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary or a health officer may communicate with a patient directly to discuss a laboratory report if:</text> <paragraph num="(a)"> <text>The physician or other health care provider caring for a patient is not reasonably available; and</text> </paragraph> <paragraph num="(b)"> <text>The Secretary or health officer records the date and time of the efforts to contact the physician or other health care provider caring for the patient and documents the:</text> <paragraph num="(i)"> <text>Name of the individual with whom a message was left; or</text> </paragraph> <paragraph num="(ii)"> <text>Identification given by the answering machine, if a message was left on an answering machine.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="General Control Measures."> <paragraph num="A."> <text>Necessary Action. The Secretary or health officer shall:</text> <paragraph num="(1)"> <text>Take any action or measure necessary to prevent the spread of communicable disease or to control a reportable disease and condition; and</text> </paragraph> <paragraph num="(2)"> <text>Issue, when necessary, special instructions for control of a disease or condition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Epidemiologic Investigations.</text> <paragraph num="(1)"> <text>A health officer shall respond to each reported outbreak or suspected outbreak of disease within the health officer's jurisdiction in order to collect data to assist in establishing adequate control measures.</text> </paragraph> <paragraph num="(2)"> <text>A health officer shall investigate a reported case or suspect case of a condition as requested by the Secretary.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary may, in conjunction with the health officers, conduct the epidemiologic investigation for each reported case or suspected case in an outbreak involving two or more jurisdictions or states.</text> </paragraph> <paragraph num="(4)"> <text>An individual, a business, a facility, or an agency, including a health care provider, school or child care facility personnel, a master of a vessel or aircraft, or a medical laboratory director, shall make available to the Secretary or a health officer all records and information necessary to the epidemiologic response or investigation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A health officer or the Secretary shall order cessation of operation of a business or facility determined or suspected to be a threat to public health until the public health threat is determined by the health officer to have ceased.</text> </paragraph> <paragraph num="D."> <text>Carrier Approval.</text> <paragraph num="(1)"> <text>A health officer shall grant or deny approval to a carrier of an infectious agent to work in any of the following occupations involving:</text> <paragraph num="(a)"> <text>Care of young children;</text> </paragraph> <paragraph num="(b)"> <text>Care of the elderly;</text> </paragraph> <paragraph num="(c)"> <text>Food handling; and</text> </paragraph> <paragraph num="(d)"> <text>Patient care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health officer shall grant or deny approval to a carrier of an infectious agent to attend a:</text> <paragraph num="(a)"> <text>School; or</text> </paragraph> <paragraph num="(b)"> <text>Child care facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A health officer shall consider the following when granting or denying approval to a carrier of an infectious agent to work in occupations or to attend settings listed under §D(1) and (2) of this regulation:</text> <paragraph num="(a)"> <text>The seriousness of the disease;</text> </paragraph> <paragraph num="(b)"> <text>The route or routes of transmission of the disease;</text> </paragraph> <paragraph num="(c)"> <text>The contagiousness of the disease;</text> </paragraph> <paragraph num="(d)"> <text>The behavior, neurological development and condition, and physical condition of the carrier;</text> </paragraph> <paragraph num="(e)"> <text>The susceptibility to the disease of those likely to be exposed to the carrier in the occupation or setting;</text> </paragraph> <paragraph num="(f)"> <text>The precautions that may be taken to minimize or eliminate the danger of transmission; and</text> </paragraph> <paragraph num="(g)"> <text>Precedents in the practice of public health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Control of Food Handlers. A case with any of the following diseases may not serve or handle, in any manner whatsoever, food intended for public consumption:</text> <paragraph num="(1)"> <text>Disease causing diarrhea, unless physician-certified as noninfectious;</text> </paragraph> <paragraph num="(2)"> <text>Cholera;</text> </paragraph> <paragraph num="(3)"> <text>Escherichia coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC), as discussed in Regulation .08-3 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Hepatitis A, as discussed in Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Salmonellosis, as discussed in Regulation .16 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Shigellosis, as discussed in Regulation .19 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Typhoid or Paratyphoid fever or carrier of Salmonella Typhi or Paratyphi, as discussed in Regulation .21 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Control of Communicable Diseases in Schools and Child Care Facilities.</text> <paragraph num="(1)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Maintain the right to make physical inspections of pupils, teachers, or other persons attending, employed, or volunteering in schools or child care facilities whenever, in the judgment of the health officer, the inspections are necessary to investigate a suspected communicable disease; and</text> </paragraph> <paragraph num="(b)"> <text>Determine whether enrollees, pupils, or other individuals attending schools or child care facilities have received the immunizations required under COMAR 10.06.04, 13A.15.03.02, or 13A.16.03.04.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The principal or other person in charge of any school or child care facility shall comply with a measure or special instruction issued by the Secretary or a health officer under Regulation .06A of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Use of Sterile Instruments or Equipment. An individual who performs a procedure that penetrates the skin or mucous membrane of another individual shall:</text> <paragraph num="(1)"> <text>Utilize only sterile instruments or equipment for the procedure;</text> </paragraph> <paragraph num="(2)"> <text>Discard, after a single use, in accordance with COMAR 10.06.06, 26.13.11, and 26.13.12, any instruments or equipment designed for single use; and</text> </paragraph> <paragraph num="(3)"> <text>Clean and sterilize before reuse any instruments or equipment designed for multiple use.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Skin-Penetrating Body Adornment Procedures — Infection Control.</text> <paragraph num="(1)"> <text>An individual who performs a skin-penetrating body adornment procedure shall:</text> <paragraph num="(a)"> <text>Disclose the risks of the procedure, obtain the client's written consent for the performance of the procedure or, in the case of a minor, the consent of the parent or guardian, and retain the consent on file for a period of 3 years and make it available to the health officer, if requested;</text> </paragraph> <paragraph num="(b)"> <text>Maintain records of the name of the customer, the date and type of procedure performed, and the technician performing the procedure for a period of 3 years and make these records available to the health officer, if requested;</text> </paragraph> <paragraph num="(c)"> <text>Perform the procedure in a separate, enclosed room that has adequate lighting, and floors, walls, and a ceiling that are constructed to be smooth, impervious, and washable;</text> </paragraph> <paragraph num="(d)"> <text>Use only sterile instruments, equipment, and bandages;</text> </paragraph> <paragraph num="(e)"> <text>Wash both hands using soap and running water and dry the hands using individual single-use towels before and after each procedure;</text> </paragraph> <paragraph num="(f)"> <text>Wear single-use disposable latex or vinyl gloves for each procedure and discard the gloves after the procedure is completed;</text> </paragraph> <paragraph num="(g)"> <text>Wear a gown and face shield, or goggles and a mask, if spattering of blood is likely to occur during the procedure;</text> </paragraph> <paragraph num="(h)"> <text>Cleanse the client's skin before and after the procedure;</text> </paragraph> <paragraph num="(i)"> <text>Discard, after a single use, in accordance with COMAR 10.06.06, 26.13.11, and 26.13.12, any instruments or equipment designed for single use or any blood-soiled article;</text> </paragraph> <paragraph num="(j)"> <text>Clean and sterilize before reuse any instruments or equipment designed for multiple use;</text> </paragraph> <paragraph num="(k)"> <text>Provide written after-care instructions to the client;</text> </paragraph> <paragraph num="(l)"> <text>Use standard precautions in all situations where exposure to blood or body fluids may occur and comply with all applicable State and federal laws and regulations regarding worker protection; and</text> </paragraph> <paragraph num="(m)"> <text>Post the following notice in a prominent place:</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual who performs a procedure that penetrates the skin or mucous membrane may not:</text> <paragraph num="(a)"> <text>Perform a procedure on skin or mucous membrane that has a rash, infection, or other lesion;</text> </paragraph> <paragraph num="(b)"> <text>Perform a procedure when the person performing the procedure has an infected or bleeding lesion on the hands;</text> </paragraph> <paragraph num="(c)"> <text>Use a styptic pencil or alum block to staunch bleeding; or</text> </paragraph> <paragraph num="(d)"> <text>Reuse instruments or equipment intended for single use.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A health officer may investigate complaints received regarding compliance with this section.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Minimum Control Measures for Specific Diseases or Conditions."> <paragraph num="A."> <text>The definitions of terms used in the text and the recommendations for control included in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of disease within this State under the regulations of the Secretary, except in those instances in which the recommendations may be in conflict with Regulation .06A or Regulations .08—.21 of this chapter, in which case the regulations of the Secretary or special instructions of the Secretary or a health officer shall take precedence.</text> </paragraph> <paragraph num="B."> <text>The diseases and conditions described in Regulations .08—.21 of this chapter are subject to specific requirements and control procedures as specified.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Amebiasis."> <paragraph num="A."> <text>Control of a Case. A case may not participate in an occupation involving patient care, care of young children or the elderly, and food handling until chemotherapy is completed and 24 hours after diarrhea has ceased.</text> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>A health officer shall investigate household and close contacts whose occupations involve food handling, patient care, and care of young children or the elderly.</text> </paragraph> <paragraph num="(2)"> <text>A contact who has diarrhea shall submit three fecal specimens for examination. If a specimen is positive for Entamoeba histolytica, the contact becomes a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. Health care providers shall practice standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-1" heading="Campylobacteriosis."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>For a case with diarrhea due to or presumed due to campylobacteriosis, a health officer shall restrict or exclude a case from:</text> <paragraph num="(a)"> <text>Attending a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participating in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a case who has been without diarrhea for at least 24 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may:</text> <paragraph num="(a)"> <text>Attend a child care facility; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when:</text> <paragraph num="(a)"> <text>The case's fecal cultures are Campylobacter-free on two consecutive specimens collected:</text> <paragraph num="(i)"> <text>Not less than 24 hours apart; and</text> </paragraph> <paragraph num="(ii)"> <text>If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The health officer determines that the likelihood of disease transmission is low.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts at Increased Risk of Transmitting Campylobacteriosis.</text> <paragraph num="(1)"> <text>A health officer shall restrict or exclude a contact who has diarrhea from child care or an occupational setting until at least 24 hours after diarrhea ceases if the contact is in the household of a case or is a close contact who:</text> <paragraph num="(a)"> <text>Attends a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participates in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken:</text> <paragraph num="(a)"> <text>Not less than 24 hours apart; and</text> </paragraph> <paragraph num="(b)"> <text>If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If either of the specimens referred to in §B(2) of this regulation is positive for Campylobacter, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> <paragraph num="D."> <text>Control of Carriers. A health care provider shall apply the control measures specified in §A of this regulation to carriers in addition to cases.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-2" heading="Cholera (Vibrio cholera O1 or O139)."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>For a case with diarrhea due to or presumed due to cholera, a health officer shall restrict or exclude a case from:</text> <paragraph num="(a)"> <text>Attending a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participating in an occupation involving;</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a case who has been without diarrhea for at least 48 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may:</text> <paragraph num="(a)"> <text>Attend a child care facility; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when:</text> <paragraph num="(a)"> <text>The case's fecal cultures are Vibrio-free on two consecutive specimens collected:</text> <paragraph num="(i)"> <text>Not less than 24 hours apart; and</text> </paragraph> <paragraph num="(ii)"> <text>If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The health officer determines that the likelihood of disease transmission is low.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts at Increased Risk of Transmitting Cholera.</text> <paragraph num="(1)"> <text>A health officer shall restrict or exclude from child care or an occupational setting a contact who has diarrhea, until at least 48 hours after diarrhea ceases, if the contact is in the household of a case or is a close contact who:</text> <paragraph num="(a)"> <text>Attends a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participates in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken at:</text> <paragraph num="(a)"> <text>Not less than 24 hours apart; and</text> </paragraph> <paragraph num="(b)"> <text>If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If either of the specimens referred to in §B(2) of this regulation is positive for Vibrio cholera, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-3" heading="Escherichia coli O157:H7 and Other Shiga-Like Toxin Producing Escherichia coli (STEC)."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>A case may not attend a child care facility until:</text> <paragraph num="(a)"> <text>The case’s fecal cultures or stool Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves readmission based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A case, with or without diarrhea, may not participate in occupations involving food handling, patient care, or care of young children or the elderly until:</text> <paragraph num="(a)"> <text>The case’s fecal cultures or stool Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves resumption of occupational duties based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>A health officer shall require a culture of feces or stool Shiga-like toxin test only from a household member or other close contact who attends a child care facility or whose occupation involves food handling, patient care, or care of young children or the elderly.</text> </paragraph> <paragraph num="(2)"> <text>A household member or other close contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart.</text> </paragraph> <paragraph num="(3)"> <text>If either of the specimens submitted pursuant to §B(2) of this regulation is positive for E. coli O157:H7, other Shiga-Like Toxin Producing Escherichia coli (STEC), or Shiga-like toxin, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> <paragraph num="(4)"> <text>A household member or other close contact who currently has diarrhea or who has had an onset of diarrhea in the past 3 weeks may not attend a child care facility until:</text> <paragraph num="(a)"> <text>The household member or other close contact is without diarrhea for at least 24 hours and fecal cultures or Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves readmission based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A contact who currently has diarrhea or who has had an onset of diarrhea within the past week may not participate in occupations involving food handling, patient care, or care of young children or the elderly until:</text> <paragraph num="(a)"> <text>The contact is without diarrhea for at least 24 hours and fecal cultures or Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves resumption of occupational duties based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Foodborne and Waterborne Diseases."> <paragraph num="A."> <text>Control of a Case or Contacts. If one of the following diseases is identified, a health officer shall follow the procedures detailed in this chapter for the specific disease:</text> <paragraph num="(1)"> <text>Campylobacteriosis;</text> </paragraph> <paragraph num="(2)"> <text>Cholera;</text> </paragraph> <paragraph num="(3)"> <text>Escherichia coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC);</text> </paragraph> <paragraph num="(4)"> <text>Hepatitis, viral type A;</text> </paragraph> <paragraph num="(5)"> <text>Salmonellosis;</text> </paragraph> <paragraph num="(6)"> <text>Shigellosis; and</text> </paragraph> <paragraph num="(7)"> <text>Typhoid fever (Salmonella Typhi) or paratyphoid fever (Salmonella Paratyphi A, Salmonella Paratyphi B tartrate negative, and Salmonella Paratyphi C).</text> </paragraph> </paragraph> <paragraph num="B."> <text>Investigation and Control Measures.</text> <paragraph num="(1)"> <text>A food establishment as defined in Health-General Article, §21-301, Annotated Code of Maryland, shall provide to a health officer the information the health officer or the Secretary determines to be necessary and pertinent to the investigation.</text> </paragraph> <paragraph num="(2)"> <text>A health officer or the Secretary shall investigate the source, inspect food establishments, and collect samples of suspected foods and clinical specimens from food service workers and cases or contacts in an effort to determine the cause of a foodborne illness.</text> </paragraph> <paragraph num="(3)"> <text>A health officer or the Secretary shall submit all samples for laboratory examination.</text> </paragraph> <paragraph num="(4)"> <text>A health officer or the Secretary may detain a food item, issue a public notice requiring the recall or return of a food item, or prohibit the serving of food at a food service facility, until it is determined whether the food item or the facility is implicated as a source of illness.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Hepatitis, Viral Type A."> <paragraph num="A."> <text>Control of a Case. A case may not participate in an occupation involving food handling, patient care, or care of young children or the elderly for 1 week after onset of jaundice, or for 2 weeks after the onset of illness, if not jaundiced.</text> </paragraph> <paragraph num="B."> <text>Control of Contacts. For an individual who previously has not received hepatitis A vaccine, the physician in attendance or a health officer shall offer a single dose of single antigen hepatitis A vaccine or immune globulin to contacts for prophylaxis:</text> <paragraph num="(1)"> <text>As soon as possible, but within 2 weeks of exposure to household, sexual, child care, or other contacts as determined by a health officer; and</text> </paragraph> <paragraph num="(2)"> <text>According to the following recommendations:</text> <paragraph num="(a)"> <text>For a previously unvaccinated healthy individual 12 months old to 40 years old, single antigen hepatitis A vaccine at the age appropriate dose is recommended;</text> </paragraph> <paragraph num="(b)"> <text>For a previously unvaccinated individual older than 40 years old, immune globulin is recommended and single antigen hepatitis A vaccine may be used if:</text> <paragraph num="(i)"> <text>Immune globulin is not available; and</text> </paragraph> <paragraph num="(ii)"> <text>The individual is healthy; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For a previously unvaccinated child younger than 12 months old, an immunocompromised individual, an individual with chronic liver disease, or an individual for whom vaccine is contraindicated, immune globulin is recommended.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. Health care providers shall practice standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Hepatitis, Viral Type B."> <paragraph num="A."> <text>Control of a Case. A physician in attendance upon a case having viral hepatitis type B shall educate that case on the:</text> <paragraph num="(1)"> <text>Risks of sexual transmission, household contact transmission, maternal-infant transmission, and transmission by the sharing of hypodermic needles and other drug paraphernalia;</text> </paragraph> <paragraph num="(2)"> <text>Availability of hepatitis B vaccine and hepatitis B immune globulin for contacts who have had sexual contact with a case of hepatitis B within the preceding 14 days, contacts who have percutaneous exposures to hepatitis B, and infants born to case mothers who carry hepatitis B virus at delivery, and the need for referring those contacts to health care providers for preventive treatment;</text> </paragraph> <paragraph num="(3)"> <text>Importance of vaccination for viral hepatitis type A if the case is not already immune by reason of prior infection or prior vaccination; and</text> </paragraph> <paragraph num="(4)"> <text>Importance of testing pregnant women for hepatitis B surface antigen at each pregnancy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts. A physician or health officer in attendance upon a contact of viral hepatitis type B shall:</text> <paragraph num="(1)"> <text>Educate that contact about the availability of vaccine and hepatitis B immune globulin for contacts with exposure to the case’s blood or other infectious body fluids;</text> </paragraph> <paragraph num="(2)"> <text>Recommend preventive treatment consistent with current Centers for Disease Control and Prevention guidelines based on type of exposure; and</text> </paragraph> <paragraph num="(3)"> <text>Require that infants born to hepatitis B surface antigen positive mothers:</text> <paragraph num="(a)"> <text>Receive hepatitis B immune globulin and the first dose of hepatitis B vaccine within 12 hours of birth;</text> </paragraph> <paragraph num="(b)"> <text>Receive the rest of the vaccination series; and</text> </paragraph> <paragraph num="(c)"> <text>Are tested for hepatitis B surface antigen and hepatitis B surface antibody at 9 to 15 months old.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. Health care providers shall practice standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11-1" heading="Hepatitis, Viral Type C."> <paragraph num="A."> <text>Control of a Case. A physician in attendance upon a case of viral hepatitis type C shall educate that case on:</text> <paragraph num="(1)"> <text>The risks of transmission of viral hepatitis type C by:</text> <paragraph num="(a)"> <text>Sharing hypodermic needles and other injecting drug paraphernalia;</text> </paragraph> <paragraph num="(b)"> <text>Sexual transmission;</text> </paragraph> <paragraph num="(c)"> <text>Maternal-child transmission;</text> </paragraph> <paragraph num="(d)"> <text>Parenteral or permucosal exposure to blood or other infectious body fluids;</text> </paragraph> <paragraph num="(e)"> <text>Chronic hemodialysis;</text> </paragraph> <paragraph num="(f)"> <text>Transfusion; and</text> </paragraph> <paragraph num="(g)"> <text>Transplantation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>How to reduce the risk of transmission of viral hepatitis type C to other individuals;</text> </paragraph> <paragraph num="(3)"> <text>The importance of an individual health evaluation to determine if treatment should be recommended;</text> </paragraph> <paragraph num="(4)"> <text>The importance of vaccination for viral hepatitis types A and B if the case is not already immune by reason of prior infection or prior vaccination; and</text> </paragraph> <paragraph num="(5)"> <text>The prevention of further liver injury or more serious liver disease or liver failure.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts. A physician or health officer in attendance upon a contact of viral hepatitis type C shall educate the contact about:</text> <paragraph num="(1)"> <text>Any risk factors and signs of infection due to viral hepatitis type C;</text> </paragraph> <paragraph num="(2)"> <text>Testing that is available to determine whether an infection due to viral hepatitis type C is present, and facilitate that testing if medically appropriate or if requested by the contact; and</text> </paragraph> <paragraph num="(3)"> <text>How to reduce the contact's risk of receiving viral hepatitis type C from others.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall:</text> <paragraph num="(1)"> <text>Practice standard precautions; and</text> </paragraph> <paragraph num="(2)"> <text>Implement and maintain, in hemodialysis centers and other settings where viral hepatitis type C transmission is known to be an increased risk, additional infection control measures based upon the Centers for Disease Control and Prevention recommendations for prevention and control of hepatitis C infection and HCV-related chronic disease, as directed by the Secretary to reduce disease transmission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Education. The Secretary, with the assistance of the health officer, shall provide professional and public education and informational materials on viral hepatitis type C, modes of transmission, and prevention of viral hepatitis type C.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Measles (Rubeola)."> <paragraph num="A."> <text>Control of a Case. A health officer or health care provider shall recommend that a case may not attend a school, workplace, or child care facility from the onset of the illness at least through the 4th day after the rash appears.</text> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>Nonimmune Contacts.</text> <paragraph num="(a)"> <text>Nonimmune individuals for measles, in general, are people who:</text> <paragraph num="(i)"> <text>Have not received two doses of measles containing vaccine on or after the first birthday;</text> </paragraph> <paragraph num="(ii)"> <text>Have no documentation of immunity or disease; or</text> </paragraph> <paragraph num="(iii)"> <text>Were born in or after 1957.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A health officer or health care provider shall recommend that:</text> <paragraph num="(i)"> <text>Nonimmune contacts receive measles vaccine within 72 hours of exposure if not medically contraindicated; and</text> </paragraph> <paragraph num="(ii)"> <text>Nonimmune household or other close contacts, particularly contacts younger than 1 year old, pregnant women, persons with immunodeficiencies, or those for whom the vaccine is contraindicated, be given immune globulin within 6 days of exposure.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 21 days after the onset of rash in the last case of measles.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health officer:</text> <paragraph num="(a)"> <text>May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of measles is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and</text> </paragraph> <paragraph num="(b)"> <text>Shall authorize readmission upon documented proof of immunity in the form of immunization record, serologic test, or the low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. Health care providers shall practice airborne precautions from the onset of illness at least through the 4th day after the rash appears.</text> </paragraph> <paragraph num="D."> <text>Proof of Immunity for Health Care Workers.</text> <paragraph num="(1)"> <text>A worker born in or after 1957 working at least 20 hours each week who is newly retained as medical staff, a direct or contractual employee, or a volunteer of a hospital classified as a “general hospital” under Health-General Article, §19-307, Annotated Code of Maryland, shall have documentation of receipt of two doses of live measles virus vaccine after becoming 1 year old or proof of immunity by blood test for antibody to rubeola. The hospital shall keep the measles vaccination or immunity status of each worker on file.</text> </paragraph> <paragraph num="(2)"> <text>Exemptions.</text> <paragraph num="(a)"> <text>A hospital shall grant a medical exemption for any worker who presents a written statement from a licensed physician or a health officer indicating that immunization against measles is medically contraindicated or detrimental to the worker's health. The statement shall indicate whether the exemption should be permanent or temporary. If the exemption is temporary, the statement shall indicate the date on which the worker is to receive the immunization. A hospital shall withdraw a temporary medical exemption on the day following that date. If the exemption is permanent, the hospital shall maintain a record of the worker's measles antibody test results.</text> </paragraph> <paragraph num="(b)"> <text>If a worker objects to an immunization upon the grounds that it conflicts with the worker's bona fide religious beliefs and practices, the hospital shall grant a religious exemption to the worker for the immunization. The hospital shall maintain a record of the worker's measles antibody test results.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12-1" heading="Mumps."> <paragraph num="A."> <text>Control of a Case. A health officer or health care provider shall recommend that a case may not attend a school, workplace, or child care facility from the onset of illness through the 5th day after onset of parotitis.</text> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>Nonimmune Individuals.</text> <paragraph num="(a)"> <text>Nonimmune individuals for mumps, in general, are people who:</text> <paragraph num="(i)"> <text>Have not received two doses of mumps containing vaccine on or after the first birthday;</text> </paragraph> <paragraph num="(ii)"> <text>Have no documentation of immunity or disease; or</text> </paragraph> <paragraph num="(iii)"> <text>Were born in or after 1957.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 25 days after the onset of parotitis in the last case of mumps.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health officer:</text> <paragraph num="(a)"> <text>May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of mumps is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and</text> </paragraph> <paragraph num="(b)"> <text>Shall authorize readmission upon documented proof of immunity in the form of:</text> <paragraph num="(i)"> <text>An immunization record;</text> </paragraph> <paragraph num="(ii)"> <text>A serologic test; or</text> </paragraph> <paragraph num="(iii)"> <text>The low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice droplet precautions for 5 days after onset of parotitis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12-2" heading="Pertussis."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>A health officer or health care provider shall recommend that a case may not attend school, a workplace, or a child care facility until the patient has received at least 5 days of appropriate antibiotics.</text> </paragraph> <paragraph num="(2)"> <text>If a case does not receive antibiotics, a health officer shall restrict or exclude the case from attending a school, health care facility, child care facility, or workplace for 3 weeks after onset of cough.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts. A health officer may:</text> <paragraph num="(1)"> <text>Require all inadequately immunized household contacts younger than 7 years old to be excluded from schools, child care facilities, and public gatherings:</text> <paragraph num="(a)"> <text>For 21 days after last exposure; or</text> </paragraph> <paragraph num="(b)"> <text>Until the case patients and contacts have received 5 days of appropriate antibiotics;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Require all contacts to verify immunization status and be brought up to date if not adequately immunized to protect against subsequent exposure; and</text> </paragraph> <paragraph num="(3)"> <text>Require antibiotic prophylaxis for contacts of cases.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice droplet precautions for the shorter of:</text> <paragraph num="(1)"> <text>21 days after onset of cough; or</text> </paragraph> <paragraph num="(2)"> <text>When a case has been on appropriate antibiotics for 5 days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Psittacosis."> <paragraph num="A."> <text>There is no control of a human case or contacts.</text> </paragraph> <paragraph num="B."> <text>Infection Control. A health care provider shall practice appropriate disinfection and disposal of respiratory discharges.</text> </paragraph> <paragraph num="C."> <text>The sale and distribution of exotic birds and handling of exotic birds which are cases or suspected cases of avian psittacosis are subject to Health-General Article, §§24-101—24-110, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Department recommends that the Compendium of Measures To Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017, by the National Association of State Public Health Veterinarians, be followed for ill birds and birds that carry psittacosis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Rabies."> <paragraph num="A."> <text>Control of a Case (Human). A health care provider shall apply contact isolation to the case for the period of communicability.</text> </paragraph> <paragraph num="B."> <text>Control of Contacts. A health officer or health care provider shall evaluate individually a close contact or hospital contact to determine the need for post-exposure rabies prophylaxis. A health care provider shall warn an immediate attendant of the hazard of infection.</text> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice contact isolation.</text> </paragraph> <paragraph num="D."> <text>Confinement or Examination of Animals. A health officer or the Maryland Public Health Veterinarian shall direct the quarantine, examination, control, and disposition of any animal that bites or otherwise potentially exposes a human to rabies, according to COMAR 10.06.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Rubella (German Measles)."> <paragraph num="A."> <text>Control of a Case. A health officer or health care provider shall recommend that a case:</text> <paragraph num="(1)"> <text>Be isolated from a woman of childbearing age who is not immune or is of unknown immunity, from the onset of illness through the 7th day after appearance of the rash; and</text> </paragraph> <paragraph num="(2)"> <text>May not attend a school, workplace, or child care facility from the onset of the illness through the 7th day after the appearance of the rash.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>Nonimmune Contacts.</text> <paragraph num="(a)"> <text>Nonimmune individuals for rubella, in general, are people who:</text> <paragraph num="(i)"> <text>Have not received at least one dose of rubella containing vaccine on or after the first birthday;</text> </paragraph> <paragraph num="(ii)"> <text>Have no documentation of immunity or disease; or</text> </paragraph> <paragraph num="(iii)"> <text>Were born in or after 1957.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 21 days after the onset of rash in the last case of rubella.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health officer:</text> <paragraph num="(a)"> <text>May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of rubella is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and</text> </paragraph> <paragraph num="(b)"> <text>Shall authorize readmission by documented proof of immunity in the form of an immunization record, serologic test, or the low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice droplet precaution for 7 days after onset of the rash.</text> </paragraph> <paragraph num="D."> <text>Proof of Immunity for Health Care Workers.</text> <paragraph num="(1)"> <text>A worker born in or after 1957 working at least 20 hours each week who is newly retained as medical staff, a direct or contractual employee, or a volunteer of a hospital classified as a “general hospital” under Health-General Article, §19-307, Annotated Code of Maryland, shall have documentation of receipt of either one dose of live rubella virus vaccination on or after becoming 1 year old or proof of immunity by blood test for antibody to rubella. The hospital shall keep the vaccine or immunity status of each worker on file.</text> </paragraph> <paragraph num="(2)"> <text>Exemptions.</text> <paragraph num="(a)"> <text>A hospital shall grant a medical exemption for any worker who presents a written statement from a licensed physician or a health officer indicating that immunization against rubella is medically contraindicated or detrimental to the worker's health. The statement shall indicate whether the exemption should be permanent or temporary. If the exemption is temporary, the statement shall indicate the date on which the worker is to receive the immunization. A hospital shall withdraw a temporary medical exemption on the day following that date. If the exemption is permanent, the hospital shall maintain a record of the worker's rubella antibody test results.</text> </paragraph> <paragraph num="(b)"> <text>If a worker objects to an immunization upon the grounds that it conflicts with the worker's bona fide religious beliefs and practices, the hospital shall grant a religious exemption to the worker for the immunization. The hospital shall maintain a record of the worker's rubella antibody test results.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Salmonellosis."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>For a case with diarrhea due to or presumed due to salmonellosis, a health officer shall restrict or exclude a case from:</text> <paragraph num="(a)"> <text>Attending a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participating in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a case who has been without diarrhea for at least 24 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may:</text> <paragraph num="(a)"> <text>Attend a child care facility; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when:</text> <paragraph num="(a)"> <text>The case’s fecal cultures are Salmonella-free on two consecutive specimens collected:</text> <paragraph num="(i)"> <text>Not less than 24 hours apart; and</text> </paragraph> <paragraph num="(ii)"> <text>If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The health officer determines that the likelihood of disease transmission is low.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts at Increased Risk of Transmitting Salmonellosis.</text> <paragraph num="(1)"> <text>A health officer shall restrict or exclude from child care or an occupational setting a contact who has diarrhea, until at least 24 hours after diarrhea ceases, if the contact is in the household of a case or is a close contact who:</text> <paragraph num="(a)"> <text>Attends a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Participates in an occupation involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken not:</text> <paragraph num="(a)"> <text>Less than 24 hours apart; and</text> </paragraph> <paragraph num="(b)"> <text>Sooner than 48 hours following discontinuation of antibiotics if antibiotics have been given.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If either of the specimens referred to in §B(2) of this regulation is positive for Salmonella, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> <paragraph num="D."> <text>Control of Carriers. A health care provider shall apply the same control measures to carriers as to cases.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Syphilis and HIV."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>For an individual who appears to have or who has syphilis in a stage which is or may become communicable, or HIV, a physician shall instruct the individual in the use of any measure and render any treatment which may be necessary to prevent the spread of the disease.</text> </paragraph> <paragraph num="(2)"> <text>An individual under medical observation for diagnosis of syphilis or HIV shall remain under medical supervision until the:</text> <paragraph num="(a)"> <text>Observation for diagnosis has been completed;</text> </paragraph> <paragraph num="(b)"> <text>Syphilis or HIV, if present, has been reported to a health officer;</text> </paragraph> <paragraph num="(c)"> <text>Individual with syphilis has had the treatment that is necessary for the protection of the public health; and</text> </paragraph> <paragraph num="(d)"> <text>Individual with HIV has entered into HIV medical care.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A physician shall report to a health officer within 1 working day and in writing the name and address of an individual who is:</text> <paragraph num="(a)"> <text>Receiving or has received treatment for syphilis; or</text> </paragraph> <paragraph num="(b)"> <text>Under medical observation for diagnosis or treatment of syphilis in an infectious or potentially infectious stage, who fails to return for observation or treatment within 1 week of the date of a missed appointment, and is not known to the attending physician to be under medical observation or treatment elsewhere for this infection.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Investigate an individual reported to the health officer under the provisions of §A(3) of this regulation or Health-General Article, §18-201.1, Annotated Code of Maryland, who is within the health officer’s territorial jurisdiction;</text> </paragraph> <paragraph num="(b)"> <text>Take such measures as may be deemed necessary for the protection of the public health; and</text> </paragraph> <paragraph num="(c)"> <text>Forward to the Secretary immediately a report of an individual reported under the provisions of §A(3) of this regulation or Health-General Article, §18-201.1, Annotated Code of Maryland, who is outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>A physician in attendance upon a patient having syphilis or HIV:</text> <paragraph num="(a)"> <text>Shall endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by:</text> <paragraph num="(i)"> <text>Requesting a health officer to conduct a contact investigation of any case of syphilis or HIV; or</text> </paragraph> <paragraph num="(ii)"> <text>Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Shall report immediately to a health officer an individual identified as having had potentially infectious contact with a patient having syphilis reported under the provisions of §A(3) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>May report to a health officer an individual identified as having had potentially infectious contact with a patient having HIV reported under Health-General Article, §18-201.1, Annotated Code of Maryland, if a patient that has been informed of the patient’s HIV positive status refuses to notify the patient’s sexual and needle-sharing partners.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Investigate and notify immediately an individual reported under the provisions of §B(1)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with syphilis or HIV; and</text> </paragraph> <paragraph num="(b)"> <text>Forward immediately to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A reported individual shall:</text> <paragraph num="(a)"> <text>Within 1 week of notification, be examined to ascertain whether the individual has been infected with syphilis or HIV; and</text> </paragraph> <paragraph num="(b)"> <text>Be treated with a regimen appropriate for the stage of syphilis to which the individual has been exposed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> <paragraph num="D."> <text>Congenital Syphilis.</text> <paragraph num="(1)"> <text>A physician in attendance upon a pregnant woman shall:</text> <paragraph num="(a)"> <text>Serologically test her for syphilis in accordance with Health-General Article, §18-307, Annotated Code of Maryland, by taking a blood sample and assuring the test is completed:</text> <paragraph num="(i)"> <text>At the time the physician first examines the woman, either at the first prenatal visit or at the time of delivery if the woman has had no prenatal care;</text> </paragraph> <paragraph num="(ii)"> <text>In the third trimester at the prenatal visit at 28 weeks of gestation or the first prenatal visit after 28 weeks of gestation; and</text> </paragraph> <paragraph num="(iii)"> <text>At delivery, for high prevalence communities or high risk individuals;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Render appropriate treatment within 1 week whenever syphilis, in any stage, is diagnosed; and</text> </paragraph> <paragraph num="(c)"> <text>Report the case to a health officer immediately.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A physician in attendance upon an infant born to an untreated woman who has a positive serological test for syphilis shall:</text> <paragraph num="(a)"> <text>Evaluate the infant for possible congenital syphilis and render all indicated treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Report immediately to a health officer the following information:</text> <paragraph num="(i)"> <text>The name, address, and telephone number of the mother;</text> </paragraph> <paragraph num="(ii)"> <text>The results of the serological testing, including titers; and</text> </paragraph> <paragraph num="(iii)"> <text>The results of the medical evaluation for congenital syphilis for the infant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Investigate immediately an individual reported to the health officer under the provisions of §D(1)(c) and (2)(b) of this regulation, who is within the health officer's jurisdiction; and</text> </paragraph> <paragraph num="(b)"> <text>Forward immediately to the Secretary a report of an individual reported under the provisions of §D(1)(c) and (2)(b) of this regulation, who is outside the health officer's jurisdiction for referral to a health officer of the proper jurisdiction.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Other Sexually Transmitted Infections."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>Hepatitis, viral type B, as discussed in Regulation .11 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A physician in attendance upon a person who appears to have, or who has a sexually transmissible disease in a stage which is or may become communicable, shall:</text> <paragraph num="(a)"> <text>Instruct the person on the modes of transmission and the prevention of transmission;</text> </paragraph> <paragraph num="(b)"> <text>Render any necessary treatment to the case; and</text> </paragraph> <paragraph num="(c)"> <text>Advise the case to inform a sexual partner or partners of exposure and the need for examination and treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>Hepatitis, viral type B as discussed in Regulation .11 of this chapter</text> </paragraph> <paragraph num="(2)"> <text>A physician in attendance upon an individual who is a sexual contact of a case of a sexually transmitted infection shall perform a medical examination and render indicated treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prevention of Gonococcal Ophthalmia Neonatorum.</text> <paragraph num="(1)"> <text>A birth-attending physician or certified nurse-midwife shall apply to both eyes of a newborn one of the following prophylactic agents:</text> <paragraph num="(a)"> <text>A 1-percent silver nitrate solution provided in individual wax ampules for the prevention of gonococcal ophthalmia neonatorum;</text> </paragraph> <paragraph num="(b)"> <text>Tetracycline ophthalmic ointment; or</text> </paragraph> <paragraph num="(c)"> <text>Erythromycin ophthalmic ointment (USP).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A birth-attending physician or certified nurse-midwife shall document in a newborn's medical record the application of the prophylactic agent, the name of the agent used, and dose strength.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Shigellosis."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>A case may not attend a child care facility until:</text> <paragraph num="(a)"> <text>The case's fecal cultures are Shigella-free on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves readmission based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A case, with or without diarrhea, may not participate in occupations involving food handling, patient care, or care of young children or the elderly until:</text> <paragraph num="(a)"> <text>The case's fecal cultures are Shigella-free on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or</text> </paragraph> <paragraph num="(b)"> <text>A health officer approves resumption of occupational duties based on the low likelihood of disease transmission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts.</text> <paragraph num="(1)"> <text>A health officer shall require a culture of feces only from a household member or close contact who:</text> <paragraph num="(a)"> <text>Attends a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Whose occupation involves:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart.</text> </paragraph> <paragraph num="(3)"> <text>If either of the specimens collected under §B(2) of this regulation is positive for Shigella, the health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation shall apply.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Tuberculosis."> <paragraph num="A."> <text>Control of a Case and Suspected Case.</text> <paragraph num="(1)"> <text>A health care provider shall immediately send notification that they have a patient who is suspected of being in a communicable stage to the local health officer of the jurisdiction in which the patient is currently located.</text> </paragraph> <paragraph num="(2)"> <text>A health care provider may not discharge a patient who is suspected of being in a communicable stage until the local health department of the jurisdiction in which the patient is located has been informed of and concurs with the planned discharge or release of the individual.</text> </paragraph> <paragraph num="(3)"> <text>A health officer or health care provider shall isolate a patient who is in a communicable stage as long as the specific microorganism:</text> <paragraph num="(a)"> <text>Is excreted by the patient; or</text> </paragraph> <paragraph num="(b)"> <text>Can be isolated by culture in the case of multidrug resistant tuberculosis (MDR-TB) or extremely drug resistant tuberculosis (XDR-TB).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A patient fulfills the requirements of isolation as long as the patient receives adequate chemotherapy, is under medical supervision, and observes instructions for isolation issued by a health officer.</text> </paragraph> <paragraph num="(5)"> <text>A health care provider shall place individuals with tuberculosis and suspected tuberculosis on a tuberculosis treatment regimen that is in accordance with current national and State standards of care, and that provide for direct observation by a trained health care worker of ingestion of each dose of medication.</text> </paragraph> <paragraph num="(6)"> <text>A health officer or health care provider treating an individual with tuberculosis or suspected tuberculosis shall provide human immunodeficiency virus testing and counseling.</text> </paragraph> <paragraph num="(7)"> <text>A health officer shall monitor the treatment of individuals with tuberculosis and suspected tuberculosis to determine if the treatment is appropriate.</text> </paragraph> <paragraph num="(8)"> <text>A health officer may impose limitations on travel and place restrictions on hospital discharge for an individual with tuberculosis or suspected tuberculosis.</text> </paragraph> <paragraph num="(9)"> <text>A health officer may remove the limitations and restrictions set forth in §A(8) of this regulation when appropriate and consistent with the individual's tuberculosis treatment plan.</text> </paragraph> <paragraph num="(10)"> <text>A health officer or the Secretary shall manage tuberculosis patients who are noncompliant with tuberculosis treatment in accordance with Health-General Article, §§18-324 and 18-325, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>A health officer may require an individual having tuberculosis in a noncommunicable stage to be under medical supervision, which may include physical isolation from others, if the individual refuses to receive adequate chemotherapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts. A health officer shall:</text> <paragraph num="(1)"> <text>Direct that testing for tuberculosis infection using a Centers for Disease Control and Prevention approved method be performed on contacts of cases of tuberculosis in a communicable stage;</text> </paragraph> <paragraph num="(2)"> <text>Recommend appropriate treatment for latent tuberculosis infection; and</text> </paragraph> <paragraph num="(3)"> <text>Provide for the supervised presumptive treatment of latent tuberculosis infection for a child younger than 5 years old identified as a close contact to a confirmed case or suspected case of active pulmonary tuberculosis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Typhoid Fever (Salmonella Typhi) and Paratyphoid Fever (Salmonella Paratyphi A, Salmonella Paratyphi B tartrate negative, and Salmonella Paratyphi C)."> <paragraph num="A."> <text>Control of a Case.</text> <paragraph num="(1)"> <text>A case may not attend a child care facility until fecal specimens are Salmonella-free on three consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, or until a health officer approves readmission based on the low likelihood of transmission.</text> </paragraph> <paragraph num="(2)"> <text>A case may not participate in occupations involving food handling, patient care, or care of young children or the elderly until fecal specimens are Salmonella-free on three consecutive specimens collected not less than 24 hours apart, and not sooner than 48 hours after discontinuation of antibiotics.</text> </paragraph> <paragraph num="(3)"> <text>A health officer shall supervise a case and release a case from supervision only after fecal specimens are culture negative for Salmonella Typhi or Paratyphi on three consecutive specimens collected not:</text> <paragraph num="(a)"> <text>Less than 24 hours apart;</text> </paragraph> <paragraph num="(b)"> <text>Sooner than 48 hours following discontinuation of antibiotics; and</text> </paragraph> <paragraph num="(c)"> <text>Earlier than 1 month after onset or date of first positive culture if asymptomatic.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If any one of the specimens required in §A(3) of this regulation is positive, at least three consecutive negative cultures of feces at intervals of 1 month within the 12 months following onset shall be required for release from supervision.</text> </paragraph> <paragraph num="(5)"> <text>If a person continues to excrete Salmonella Typhi or Paratyphi at 12 months, the requirements of §D of this regulation apply.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Control of Contacts of a Case. Household, sexual, and other close contacts of a case may not attend a child care facility or participate in occupations involving food handling, patient care, or care of young children or the elderly until two consecutive cultures of feces taken at least 24 hours apart are negative for Salmonella Typhi or Paratyphi.</text> </paragraph> <paragraph num="C."> <text>Infection Control. A health care provider shall practice standard precautions.</text> </paragraph> <paragraph num="D."> <text>Control of Carriers.</text> <paragraph num="(1)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Monitor the location, occupation, and bacteriological status of a carrier of Salmonella Typhi or Paratyphi;</text> </paragraph> <paragraph num="(b)"> <text>Keep a complete file of all pertinent data on the carrier;</text> </paragraph> <paragraph num="(c)"> <text>Issue written instructions to the carrier concerning the restrictions upon and responsibilities of the carrier;</text> </paragraph> <paragraph num="(d)"> <text>Notify the carrier of the availability of treatments that may eliminate carriage;</text> </paragraph> <paragraph num="(e)"> <text>Contact each carrier in the health officer's jurisdiction at intervals of not more than 1 year to check on the carrier's occupation and address and to determine if all instructions are being followed;</text> </paragraph> <paragraph num="(f)"> <text>Release a carrier from supervision only after there have been three consecutive negative cultures of feces, taken 1 month apart at least 48 hours after antibiotic treatment; and</text> </paragraph> <paragraph num="(g)"> <text>Forward immediately to the Secretary a report of a carrier who has relocated outside the health officer's territorial jurisdiction for referral to the health officer of the proper jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A case or a case's physician shall submit the fecal specimens to the State Laboratory for the release of a carrier.</text> </paragraph> <paragraph num="(3)"> <text>A carrier:</text> <paragraph num="(a)"> <text>May not participate in occupations involving:</text> <paragraph num="(i)"> <text>Food handling;</text> </paragraph> <paragraph num="(ii)"> <text>Patient care; or</text> </paragraph> <paragraph num="(iii)"> <text>Care of young children or the elderly;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Shall abide by Regulation .06D and E; and</text> </paragraph> <paragraph num="(c)"> <text>Shall keep a health officer informed at all times of the carrier's address and occupation, and shall notify the health officer at once of any change in address or occupation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Control of Contacts of a Carrier.</text> <paragraph num="(1)"> <text>A health officer shall require culture of feces of those household and close contacts:</text> <paragraph num="(a)"> <text>Who attend a child care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Whose occupations involve:</text> <paragraph num="(i)"> <text>Food handling; or</text> </paragraph> <paragraph num="(ii)"> <text>Care of patients, young children, or the elderly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart.</text> </paragraph> <paragraph num="(3)"> <text>If either of the specimens required in §E(2) of this regulation is positive for Salmonella Typhi or Paratyphi, then the health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Sale and Distribution of Reptiles."> <paragraph num="A."> <text>Scope.</text> <paragraph num="(1)"> <text>Pursuant to the authority conferred upon the Secretary by Health-General Article, §18-219, Annotated Code of Maryland, the Secretary has determined that reptiles and reptile eggs are dangerous to human health and safety in that human contact with reptiles and reptile eggs may spread disease to humans.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary prohibits the sale or public distribution of turtles with a carapace length of less than 4 inches and viable reptile eggs.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary may permit the sale and public distribution of reptiles in accordance with specific requirements and conditions as stated in §B of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>This regulation does not apply to a turtle:</text> <paragraph num="(a)"> <text>Used for agricultural purposes;</text> </paragraph> <paragraph num="(b)"> <text>Used for scientific purposes;</text> </paragraph> <paragraph num="(c)"> <text>Used for educational purposes as certified by a health officer;</text> </paragraph> <paragraph num="(d)"> <text>Used for public exhibitions; or</text> </paragraph> <paragraph num="(e)"> <text>That the Secretary determines is not a threat to human health and safety.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The requirements of this regulation are in addition to any requirement imposed by Natural Resources Article, Title 10, Subtitle 9, Annotated Code of Maryland, and regulations adopted under it.</text> </paragraph> <paragraph num="(6)"> <text>The giving away of reptiles is subject to the crimes and punishments set forth in Criminal Law Article, §10-610, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reptile Sales.</text> <paragraph num="(1)"> <text>A person may not sell in Maryland viable reptile eggs or live turtles with a carapace length of less than 4 inches, except as otherwise provided in §A(4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A person may sell turtles with a carapace length of 4 inches or more and other live reptiles in Maryland if:</text> <paragraph num="(a)"> <text>A caution notice with the text as indicated in §C of this regulation is:</text> <paragraph num="(i)"> <text>Posted by the person selling reptiles;</text> </paragraph> <paragraph num="(ii)"> <text>Posted within 3 feet of each display of reptiles; and</text> </paragraph> <paragraph num="(iii)"> <text>A minimum of 8 x 11 inches in size; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>At the time of the sale of a reptile, the seller:</text> <paragraph num="(i)"> <text>Furnishes the buyer with a copy of the caution notice; or</text> </paragraph> <paragraph num="(ii)"> <text>Has the buyer sign a log or statement that the buyer has read the caution notice.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Caution Notice. A person who sells reptiles shall post a caution notice that:</text> <paragraph num="(1)"> <text>Is in 4 parts, each separated by a horizontal 4-point rule;</text> </paragraph> <paragraph num="(2)"> <text>In part 1 has the word “Caution” set in 100-point Times Roman Bold;</text> </paragraph> <paragraph num="(3)"> <text>In part 2 has the following paragraph set in 30-point Times Roman: “Reptiles and other pets may carry and transmit germs (including Salmonella) to humans. It is important to wash your hands thoroughly after handling reptiles and other pets or coming in contact with their water, food, housing material, or container. Do not allow pet water, food, or housing material to come in contact with your food or areas where food is prepared.”;</text> </paragraph> <paragraph num="(4)"> <text>In part 3 has the following sentence set in 42-point Times Roman Bold: “Provide your reptiles and other pets with a clean home, a suitable diet, and other proper care.”; and</text> </paragraph> <paragraph num="(5)"> <text>In part 4 has the following sentence set in 30-point Times Roman: “If you or any member of your family is prone to or has serious health problems or is pregnant or your family includes a child younger than 5 years old, you should consult your physician before purchase.”</text> </paragraph> </paragraph> <paragraph num="D."> <text>Penalties and Seizure of Contraband Reptiles.</text> <paragraph num="(1)"> <text>Pursuant to Health-General Article, §§18-219 and 18-222, Annotated Code of Maryland, a person who imports, transports, sells, transfers, breeds, raises, keeps, or possesses any live turtle with a carapace length of less than 4 inches, other reptiles, or reptile eggs in violation of §§A—C of this regulation is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $500, or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="(2)"> <text>An authorized law enforcement officer may seize a turtle with a carapace length of less than 4 inches, viable turtle and other reptile eggs, and other reptiles, which are considered a nuisance and a contraband pursuant to Health-General Article, §18-222, Annotated Code of Maryland, and §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Communicable Disease Information Provided With Sale and Distribution of Pet Animals."> <text>To help prevent the spread of a communicable disease, a seller or a group of sellers who prepares or causes to be prepared a pamphlet, flyer, or other printed information on the handling of one or more pet animals and who distributes the pamphlet, flyer, or other printed information, shall ensure that the pamphlet, flyer, or other printed information stresses the:</text> <paragraph num="A."> <text>Importance of handwashing after contact with a reptile or other pet animals or its surroundings; and</text> </paragraph> <paragraph num="B."> <text>Need to consult a physician if one or more of the following individuals live in the household for which a pet animal is purchased:</text> <paragraph num="(1)"> <text>A child younger than 5 years old;</text> </paragraph> <paragraph num="(2)"> <text>A pregnant woman; or</text> </paragraph> <paragraph num="(3)"> <text>An immunocompromised individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Control of Communicable Diseases in Pet Stores."> <paragraph num="A."> <text>A pet store shall utilize procedures to ensure prevention and control of diseases common to and shared among humans and animals.</text> </paragraph> <paragraph num="B."> <text>To ensure prevention and control of diseases common to and shared among humans and animals, the Department recommends that pet stores utilize the Compendium of Animal Rabies Prevention and Control, the Compendium of Measures To Control Chlamydophila psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), and the Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, issued by the National Association of State Public Health Veterinarians.</text> </paragraph> <paragraph num="C."> <text>A health officer shall annually inspect a pet store to determine compliance with §A of this regulation.</text> </paragraph> <paragraph num="D."> <text>A health officer:</text> <paragraph num="(1)"> <text>May delegate the authority to conduct annual pet store inspections to another specified agency such as, but not limited to, local animal control; and</text> </paragraph> <paragraph num="(2)"> <text>Shall execute and keep on file a written agreement with the delegated inspection agency.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Enforcement. An authorized law enforcement officer or local animal control authority shall promptly enforce a written order of a health officer or the Maryland Public Health Veterinarian issued pursuant to COMAR 10.06.02.</text> </paragraph> <paragraph num="F."> <text>Penalty. The owner of a pet store refusing or failing to comply with the provisions of this regulation is subject to the penalties set forth in Health-General Article, §§18-222, 18-604, and 24-110, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 18-102, 18-103, 18-105, 18-201, 18-201.1, 18-202, 18-205,18-208, 18-214.1, 18-307, 18-337, and 24-101—24-110, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 30, 1944</annotation> <annotation type="History" subtype="Administrative History">Amended April 1, 1966</annotation> <annotation type="History" subtype="Administrative History">Regulation .55 effective May 15, 1953</annotation> <annotation type="History" subtype="Administrative History">Regulation .56 effective October 18, 1951</annotation> <annotation type="History" subtype="Administrative History">Regulation .57 effective April 1, 1966</annotation> <annotation type="History" subtype="Administrative History">Regulation .58 effective December 20, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.54, .56, and .57 repealed and new Regulations .01—.22 adopted effective December 26, 1980 (7:26 Md. R. 2420)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02A and .03B amended as an emergency provision effective June 21, 1983 (10:14 Md. R. 1257); emergency status expired October 21, 1983</annotation> <annotation type="History" subtype="Administrative History">Regulations .02A and .03B amended effective October 24, 1983 (10:21 Md. R. 1901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14D amended as an emergency provision effective March 17, 1981 (8:7 Md. R. 639); emergency status expired August 1, 1981; adopted permanently effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 adopted as an emergency provision effective September 2, 1980 (7:20 Md. R. 1872); adopted permanently effective February 6, 1981 (8:3 Md. R. 227)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.22, .31, .55, and .58 repealed effective August 7, 1989 (16:15 Md. R. 1650)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 and .19—.24 adopted effective August 7, 1989 (16:15 Md. R. 1650)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted effective February 19, 1990 (17:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 5, 1993 (20:13 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended and Regulation .06G adopted as an emergency provision effective December 3, 1996 (23:26 Md. R. 1856); amended permanently effective March 24, 1997 (24:6 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17D amended as an emergency provision effective December 5, 1997 (24:26 Md. R. 1751); amended permanently effective January 26, 1998 (25:2 Md. R. 76)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 20, 2003 (30:1 Md. R. 24)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 12, 2007 (34:17 Md. R. 1505); emergency status extended at 35:3 Md. R. 285; amended permanently effective January 14, 2008 (35:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 13, 2006 (33:5 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 13, 2006 (33:5 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-2A, B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17-1 adopted as an emergency provision effective July 12, 2007 (34:17 Md. R. 1505); emergency status extended at 35:3 Md. R. 285; adopted permanently effective January 14, 2008 (35:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective October 1, 2008 (35:22 Md. R. 1946); emergency status extended at 36:10 Md. R. 714; revised permanently effective April 6, 2009 (36:7 Md. R. 522)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 24, 2017 (44:8 Md. R. 403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective April 6, 2009 (36:7 Md. R. 522)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 406); April 24, 2017 (44:8 Md. R. 403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17-1 repealed effective March 28, 2016 (43:6 Md. R. 406)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective April 24, 2017 (44:8 Md. R. 403)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective July 12, 2021 (48:14 Md. R. 538)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective July 12, 2021 (48:14 Md. R. 538)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D amended effective July 12, 2021 (48:14 Md. R. 538)</annotation> </annotations> </chapter> <chapter num="02" heading="Communicable Diseases — Rabies"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter provides for cooperative rabies control efforts by the Department, local health officers, physicians, veterinarians, and other Maryland government agencies as guided by policy statements such as the Compendium of Animal Rabies Prevention and Control, issued annually by the National Association of State Public Health Veterinarians.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adequately vaccinated” means a graduate veterinarian at a public antirabies clinic or a licensed veterinarian has:</text> <paragraph num="(a)"> <text>Immunized an animal against rabies in accordance with the current year's recommendations as circulated by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Documented the rabies immunization by issuing a valid rabies certificate.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Animal” means a nonhuman species of mammal.</text> </paragraph> <paragraph num="(3)"> <text>“Animal exposed to a rabid animal” means an animal that is known or is suspected to have had a bite from or non-bite contact with another animal that is known or suspected to be infected with rabies.</text> </paragraph> <paragraph num="(4)"> <text>“Apparently healthy” means an:</text> <paragraph num="(a)"> <text>Animal shows no signs of illness suggestive of rabies; and</text> </paragraph> <paragraph num="(b)"> <text>Investigation by the local health officer or the health officer’s designee shows that:</text> <paragraph num="(i)"> <text>The animal has not had a change in health or behavior in the past 30 calendar days, including but not limited to lethargy, lameness, weakness, slowness of movement or gait, paralysis, or loss of appetite; or</text> </paragraph> <paragraph num="(ii)"> <text>A licensed veterinarian, having examined the animal more than 30 days before the bite or non-bite contact, has identified and documented that behavior or health changes were caused by a condition unrelated to rabies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Area quarantine” means a geographic region designated by the Public Health Veterinarian within which animals of a species designated by the Public Health Veterinarian are subject to the restrictions specified in this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Bite contact” means penetration of the skin by the teeth of an animal, regardless of whether blood is visible.</text> </paragraph> <paragraph num="(7)"> <text>“Cat” means Felis catus.</text> </paragraph> <paragraph num="(8)"> <text>“Custodian” means a caretaker or keeper of an animal, or the local animal control authority who has responsibility for an unclaimed animal.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Department-approved facility” means a facility that has prior written approval of the Department to quarantine rabies suspect animals.</text> </paragraph> <paragraph num="(11)"> <text>“Dog” means Canis familiaris, not including canine hybrids.</text> </paragraph> <paragraph num="(12)"> <text>“Domestic animal” means a species of mammal that is accustomed to living in or about the habitation of man and is dependent on man for food or shelter, including but not limited to dogs, cats, ferrets, and livestock.</text> </paragraph> <paragraph num="(13)"> <text>“Feral dog or cat” means a dog or cat that:</text> <paragraph num="(a)"> <text>Shows no evidence, such as a collar, tag, or grooming, of being owned; and</text> </paragraph> <paragraph num="(b)"> <text>Exhibits savage or wild behavior or is living in the wild.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Ferret” means Mustela putorius furo.</text> </paragraph> <paragraph num="(15)"> <text>“Livestock” means domestic farm animals, including but not limited to cattle, horses and other equines, swine, sheep, and goats.</text> </paragraph> <paragraph num="(16)"> <text>“Local animal control authority” means that agency or individual appointed by the governing body of a county or the city of Baltimore to oversee animal control.</text> </paragraph> <paragraph num="(17)"> <text>“Local health department” means a county health department under the direction of a local health officer or the Baltimore City Health Department under the direction of the Baltimore City Commissioner of Health.</text> </paragraph> <paragraph num="(18)"> <text>“Local health officer” means the local health officer of a county or the Baltimore City Commissioner of Health, or the designee of the local health officer or the Commissioner of Health.</text> </paragraph> <paragraph num="(19)"> <text>Non-Bite Contact.</text> <paragraph num="(a)"> <text>“Non-bite contact” means a scratch or contamination of an abrasion, open wound, or mucous membrane with saliva or other potentially infectious material from an animal.</text> </paragraph> <paragraph num="(b)"> <text>“Non-bite contact” does not include exposure to non-infectious material such as dried saliva.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(21)"> <text>“Provoked” means that bite or non-bite contact from an animal resulted from human activity, such as an individual attempting to play with, pet, feed, handle, hold, harm, or redirect an animal’s actions.</text> </paragraph> <paragraph num="(22)"> <text>“Public Health Veterinarian” means the veterinarian designated by the Secretary as responsible for the Veterinary Public Health Program of the Department or the designee of the Public Health Veterinarian.</text> </paragraph> <paragraph num="(23)"> <text>“Quarantine” means, pursuant to an order of the Public Health Veterinarian or local health officer and on the private premises of the owner or custodian of the animal or at a Department-approved facility, confinement of an animal by leash, an escape-proof enclosure, or another manner, approved in writing by the Public Health Veterinarian or local health officer, that ensures protection of the public health.</text> </paragraph> <paragraph num="(24)"> <text>“Rabies” means an acute viral disease in humans and animals produced by a rhabdovirus belonging to the genus Lyssavirus.</text> </paragraph> <paragraph num="(25)"> <text>“Risk assessment” means the evaluation of the circumstances surrounding a bite or non-bite contact to determine the likelihood that an individual has been exposed to material potentially infectious with rabies.</text> </paragraph> <paragraph num="(26)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(27)"> <text>“Serologic monitoring” means monitoring of a dog or cat that was previously vaccinated against rabies to see if the animal demonstrates sufficient evidence of an immune response within seven days of being vaccinated against rabies.</text> </paragraph> <paragraph num="(28)"> <text>“State Epidemiologist” means the person designated as the State Epidemiologist by the Secretary or the designee of the State Epidemiologist.</text> </paragraph> <paragraph num="(29)"> <text>“Strict quarantine” means that:</text> <paragraph num="(a)"> <text>An animal is confined in an escape-proof enclosure that precludes direct contact with people and other animals;</text> </paragraph> <paragraph num="(b)"> <text>The animal is not removed from the enclosure at any time except for transport in a manner, approved in writing by the local health officer, that will safeguard the public health;</text> </paragraph> <paragraph num="(c)"> <text>Human contact with the animal is restricted to one adult caring for the animal or not allowed at all by the local health officer or Public Health Veterinarian; and</text> </paragraph> <paragraph num="(d)"> <text>The owner or custodian of the animal has signed an agreement with the local health department or animal control authority that the owner or custodian has met and agrees to meet the requirements specified in §B(28)(a)—(c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Unclaimed stray animal” means a domestic animal that is:</text> <paragraph num="(a)"> <text>Not a feral dog or cat; and</text> </paragraph> <paragraph num="(b)"> <text>Unclaimed by an owner after being held by the local animal control authority at least 72 hours for an owner to claim it.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Wild animal” means a member of a mammalian species that is:</text> <paragraph num="(a)"> <text>Not a domestic animal;</text> </paragraph> <paragraph num="(b)"> <text>A feral dog or cat; or</text> </paragraph> <paragraph num="(c)"> <text>An unclaimed stray animal.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Human Rabies."> <paragraph num="A."> <text>Reporting.</text> <paragraph num="(1)"> <text>A physician, medical authority, or another person having knowledge of or suspicion of a case of human rabies shall immediately report the facts to the local health officer.</text> </paragraph> <paragraph num="(2)"> <text>A local health officer who has received a report of a case or suspected case of human rabies shall immediately notify, by telephone or other immediate communication medium, the State Epidemiologist or the Public Health Veterinarian of the case or suspected case.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Isolation. A physician or administrator of a health care facility providing medical care to an individual who is suspected of having been infected with rabies shall isolate the individual in accordance with the order of a local health officer or the State Epidemiologist.</text> </paragraph> <paragraph num="C."> <text>Immunization; Preexposure.</text> <paragraph num="(1)"> <text>The Department shall provide rabies vaccine free of charge and the local health officer shall provide for the administration of preexposure immunization against rabies for any employee of the Department, a local health department, or another individual who provides rabies control services at the request of the Department.</text> </paragraph> <paragraph num="(2)"> <text>The local health officer may provide rabies preexposure immunization to other individuals who are determined by the Public Health Veterinarian to have a high risk of exposure to rabies infection.</text> </paragraph> <paragraph num="(3)"> <text>The local health officer shall:</text> <paragraph num="(a)"> <text>Report to the Public Health Veterinarian at least every 3 months, the number of preexposure immunizations administered; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain records of the name, address, age, sex, county of residence, occupation, and the results of any blood tests administered in conjunction with rabies preexposure immunization for each individual immunized.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Public Health Veterinarian and the State Epidemiologist shall make and distribute to local health officers recommendations on the dose and schedule of administration of rabies vaccine for the purpose of preexposure immunization of individuals.</text> </paragraph> <paragraph num="(5)"> <text>The local health officer shall administer rabies preexposure immunizations according to the recommendations developed by the Public Health Veterinarian and the State Epidemiologist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Treatment; Postexposure.</text> <paragraph num="(1)"> <text>The Public Health Veterinarian and the State Epidemiologist shall jointly issue and distribute to local health departments, physicians, hospitals, and other medical authorities, rabies postexposure treatment guidelines.</text> </paragraph> <paragraph num="(2)"> <text>A local health officer shall report to the Public Health Veterinarian:</text> <paragraph num="(a)"> <text>At least every 3 months, the number of postexposure treatments administered;</text> </paragraph> <paragraph num="(b)"> <text>At the completion of treatment, for each individual administered treatment, the individual’s:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Age;</text> </paragraph> <paragraph num="(iv)"> <text>Sex;</text> </paragraph> <paragraph num="(v)"> <text>County of residence; and</text> </paragraph> <paragraph num="(vi)"> <text>Occupation; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Other information as directed by the Public Health Veterinarian.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall ensure no one is denied rabies postexposure treatment due to the inability to pay when the treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist and recommended by a licensed health care provider.</text> </paragraph> <paragraph num="(4)"> <text>The local health officer of the jurisdiction where the resident resides shall ensure access to rabies postexposure treatment provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist.</text> </paragraph> <paragraph num="(5)"> <text>When rabies postexposure treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist, the Department shall pay the charge of the rabies biologics for persons unable to pay for them:</text> <paragraph num="(a)"> <text>Based on the current ability-to-pay schedule of the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Only after all available benefits and discounts are applied.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Animal Rabies."> <paragraph num="A."> <text>Reporting. An individual shall report immediately by telephone or in person to the local police, sheriff’s department, or local animal control authority if they know of an animal that:</text> <paragraph num="(1)"> <text>Has rabies;</text> </paragraph> <paragraph num="(2)"> <text>Is suspected of having rabies; or</text> </paragraph> <paragraph num="(3)"> <text>Has had a bite from or non-bite contact with an animal known to have or suspected of having rabies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposition of a Suspected Rabid Animal — No Bite or Non-Bite Human Contact.</text> <paragraph num="(1)"> <text>Dogs, Cats, and Ferrets.</text> <paragraph num="(a)"> <text>Except as provided in §B(3) of this regulation, the director of a Department-approved facility shall hold in strict quarantine, in a manner and place as established by the local health officer or the Public Health Veterinarian, any dog, cat, or ferret suspected of having rabies that has not had bite or non-bite contact with an individual in the preceding 10 days.</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §B(3) of this regulation, unless otherwise specified by the Public Health Veterinarian, the director of a Department-approved facility shall continue the strict quarantine of the suspected rabid animal for at least 10 days and maintain proper, humane care of the animal during the period of strict quarantine, after which the animal may be humanely killed or released to its owner or custodian or for adoption.</text> </paragraph> <paragraph num="(c)"> <text>At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, the owner, or the custodian of the animal may direct that the animal suspected of having rabies be humanely killed for the purpose of rabies testing.</text> </paragraph> <paragraph num="(d)"> <text>At any time during the strict quarantine period, the owner or custodian of the animal may direct that the animal be humanely killed.</text> </paragraph> <paragraph num="(e)"> <text>Rabies testing is not required if there is no human contact or contact with another animal.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Livestock.</text> <paragraph num="(a)"> <text>Except as provided in §B(3) of this regulation, the Public Health Veterinarian shall direct the owner or custodian of livestock that has not had bite or non-bite contact with an individual and is suspected of having rabies to hold the livestock in strict quarantine for at least 10 days and shall designate the place and manner in which the strict quarantine is to be carried out, after which the livestock may be humanely killed or released to the owner or custodian.</text> </paragraph> <paragraph num="(b)"> <text>At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, the owner, or the custodian of the animal may direct that the animal be humanely killed for the purpose of rabies testing.</text> </paragraph> <paragraph num="(c)"> <text>At any time during the strict quarantine period, the owner or custodian of the animal may direct that the animal be humanely killed.</text> </paragraph> <paragraph num="(d)"> <text>Rabies testing is not required if there is no human contact or contact with another animal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Wild Animals.</text> <paragraph num="(a)"> <text>The local health officer or Public Health Veterinarian may order a wild animal that is suspected of having rabies to be humanely killed if there is no evidence that the animal has an individual owner.</text> </paragraph> <paragraph num="(b)"> <text>If there is evidence of ownership, the Public Health Veterinarian, local health officer, or local animal control authority may order the humane killing of the animal if the owner or custodian does not appear within 24 hours to claim the animal or if there is imminent threat to human health or safety. For unclaimed stray animals, the 24-hour period is included within the period required under Regulation .02B(29) of this chapter.</text> </paragraph> <paragraph num="(c)"> <text>If an owner or custodian of the wild animal claims the animal within 24 hours, the Public Health Veterinarian may order the owner to hold the animal in strict quarantine in a place and manner determined by the Public Health Veterinarian for at least 30 days, after which it may be released to the owner or custodian if the animal has not developed rabies.</text> </paragraph> <paragraph num="(d)"> <text>At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, or the owner or custodian of the animal may direct that the animal be humanely killed for the purpose of rabies testing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Examination of Animals Suspected of Having Rabies.</text> <paragraph num="(1)"> <text>The Public Health Veterinarian or the local health officer may order a veterinary examination at any time of an animal suspected of having rabies.</text> </paragraph> <paragraph num="(2)"> <text>The examining veterinarian shall report the results of the examination to the local health officer immediately.</text> </paragraph> <paragraph num="(3)"> <text>The owner or custodian of the animal shall bear the expense of the examination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Disposition of an Animal Exposed to a Rabid Animal or to an Animal Suspected of Having Rabies.</text> <paragraph num="(1)"> <text>If the owner or custodian of a domestic animal that has been exposed to a rabid animal, or to an animal suspected of having rabies, is able to provide a current or expired rabies vaccination certificate for the animal, the owner or custodian shall:</text> <paragraph num="(a)"> <text>Have the animal re-vaccinated against rabies immediately; and</text> </paragraph> <paragraph num="(b)"> <text>Keep the animal under the owner or custodian’s control and observed for 45 calendar days or for such time as specified by the Public Health Veterinarian.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the owner or custodian of a domestic animal that has been exposed to a rabid animal, or to an animal suspected of having rabies, is unable to provide a current or expired rabies vaccination certificate:</text> <paragraph num="(a)"> <text>The owner or custodian shall:</text> <paragraph num="(i)"> <text>Have the animal humanely killed; or</text> </paragraph> <paragraph num="(ii)"> <text>Have the animal vaccinated against rabies immediately, and hold dogs and cats in strict quarantine for a minimum of 4 months and other animals in strict quarantine for a minimum of 6 months in a facility and a manner approved by the Public Health Veterinarian; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The local health officer or animal control authority may consult with the Public Health Veterinarian to determine if serologic monitoring can be used to keep a dog or cat under the owner or custodian’s control and observed for 45 calendar days rather than under strict quarantine for 4 months if the owner or custodian of a dog or cat states that the dog or cat was previously vaccinated.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The owner or custodian of a domestic animal that is being held in strict quarantine is responsible for all costs related to strict quarantine of the animal.</text> </paragraph> <paragraph num="(4)"> <text>The local health officer, the Public Health Veterinarian, or the local animal control authority may make inspections of the site where an animal is being held in strict quarantine to assure that the animal is being held in strict quarantine under the terms specified in this chapter.</text> </paragraph> <paragraph num="(5)"> <text>The local health officer or the Public Health Veterinarian may order the humane killing for rabies testing of an animal exposed to a rabid animal or to an animal suspected of having rabies if:</text> <paragraph num="(a)"> <text>The strict quarantine agreement defined in Regulation .02B(28) of this chapter is violated;</text> </paragraph> <paragraph num="(b)"> <text>The animal shows signs of having developed rabies;</text> </paragraph> <paragraph num="(c)"> <text>A bite or non-bite contact to a human occurs;</text> </paragraph> <paragraph num="(d)"> <text>A bite or non-bite contact to another animal occurs;</text> </paragraph> <paragraph num="(e)"> <text>The animal is a wild animal; or</text> </paragraph> <paragraph num="(f)"> <text>The exposed animal poses an imminent threat to human health or safety.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reporting Bite or Non-Bite Contacts to Humans."> <paragraph num="A."> <text>A person having knowledge of an individual's having a bite from or non-bite contact with an animal shall report the facts of the contact immediately by telephone or in person to the local police or sheriff's department, except in Frederick County, where the person shall report the facts to the animal control center of Frederick County.</text> </paragraph> <paragraph num="B."> <text>Except as provided at §C of this regulation, upon receipt of a report, the local police or sheriff's department or animal control personnel shall:</text> <paragraph num="(1)"> <text>Complete the Maryland Animal-Bite Report and Rabies Quarantine Agreement Form supplied by the Department, or an equivalent form developed by the local health department;</text> </paragraph> <paragraph num="(2)"> <text>Make the report available within 24 hours to the local health officer and, on request, to the Public Health Veterinarian; and</text> </paragraph> <paragraph num="(3)"> <text>Enforce all orders of the local health officer and the Public Health Veterinarian pursuant to this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The local health officer shall report the number of animal bite and non-bite contacts to the Public Health Veterinarian monthly as specified in COMAR 10.06.01.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Risk Assessment Following Bite or Non-Bite Contact to Humans."> <text>Following the report of a bite or non-bite contact to a human, the local health officer shall conduct a risk assessment that includes a determination of:</text> <paragraph num="A."> <text>The species of animal that made the contact;</text> </paragraph> <paragraph num="B."> <text>Whether the animal is apparently healthy;</text> </paragraph> <paragraph num="C."> <text>Whether the animal is adequately vaccinated appropriate to its age;</text> </paragraph> <paragraph num="D."> <text>The type of contact;</text> </paragraph> <paragraph num="E."> <text>Whether the bite or non-bite contact was provoked and what human activity may have provoked the bite or non-bite; and</text> </paragraph> <paragraph num="F."> <text>The reasonable likelihood that the contact animal may have rabies or may have been exposed to rabies within the past 6 months, including information about unsupervised out-of-doors escape episodes, injuries, and other potential contacts of the animal to wild animals or bats.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disposition of Animals Following Bite or Non-Bite Contact to Humans."> <paragraph num="A."> <text>When the local health officer has determined that quarantine of the exposing animal is allowable based on the findings of the risk assessment, the animal shall be quarantined.</text> </paragraph> <paragraph num="B."> <text>Quarantine Period.</text> <paragraph num="(1)"> <text>Dogs, Cats, and Ferrets, Including Unclaimed Stray Animals. Except as provided in §B(3) and (4) of this regulation, the owner or custodian of a dog, cat, or ferret that was involved in bite or non-bite contact with a human shall quarantine the animal in a place and manner approved by the local health officer or the Public Health Veterinarian for at least 10 days after the date of the bite or contact.</text> </paragraph> <paragraph num="(2)"> <text>Livestock Including Unclaimed Stray Animals. Except as provided in §B(3) and (4) of this regulation, the owner or custodian of livestock that has been involved in bite or non-bite contact with an individual shall quarantine the livestock in a place and manner approved by the Public Health Veterinarian in consultation with the Maryland Department of Agriculture for at least 10 days after the date of the bite or contact or a time period specified by the Public Health Veterinarian.</text> </paragraph> <paragraph num="(3)"> <text>Wild Animals.</text> <paragraph num="(a)"> <text>Except in situations in which the local health officer or the Public Health Veterinarian determines that an animal poses an imminent threat to public health or safety and must be killed immediately, the Public Health Veterinarian may order a wild animal involved in bite or non-bite contact with an individual to be placed in quarantine for at least 24 hours.</text> </paragraph> <paragraph num="(b)"> <text>If the animal is not claimed by an owner or custodian within that 24-hour period, the Public Health Veterinarian may order the animal to be humanely killed and its head submitted to the laboratory designated by the Department for rabies testing.</text> </paragraph> <paragraph num="(c)"> <text>For unclaimed stray animals, the 24-hour period is included within the period required under Regulation .02B(29) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Wild Animal with a Legal Owner. When a legally owned wild animal has been involved in bite or a non-bite contact with a human, the local health officer, in consultation with the Public Health Veterinarian, shall determine the disposition of the wild animal based on its individual risk assessment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Conditions of Quarantine.</text> <paragraph num="(1)"> <text>The Public Health Veterinarian or the local health officer may order the owner or custodian of an animal under quarantine that has had bite or non-bite contact with a human to have the animal examined by a Maryland-licensed veterinarian at any time during the quarantine period.</text> </paragraph> <paragraph num="(2)"> <text>The owner or custodian of an animal under quarantine shall pay for the cost of the veterinary examination and other associated costs.</text> </paragraph> <paragraph num="(3)"> <text>If a Maryland-licensed veterinarian determines that a quarantined animal has possible rabies manifestations, the veterinarian may humanely kill the animal and submit its head promptly through the local health officer or local animal control authority to the laboratory designated by the Department for testing for rabies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Limitation on Movement During Quarantine. A person may not move an animal under quarantine from the place of quarantine without the written permission of the local health officer or the Public Health Veterinarian.</text> </paragraph> <paragraph num="E."> <text>Humane Killing of an Animal for Rabies Testing. The local health officer or the Public Health Veterinarian may order in writing the humane killing of an animal that has had bite or non-bite contact with a human for the purpose of rabies testing if:</text> <paragraph num="(1)"> <text>The local health officer has determined that the contact animal is reasonably likely to have rabies based on the risk assessment;</text> </paragraph> <paragraph num="(2)"> <text>The owner or custodian requests humane destruction during the quarantine;</text> </paragraph> <paragraph num="(3)"> <text>The animal is a wild animal unclaimed for at least 24 hours by an owner or custodian, with, for unclaimed stray animals, the 24-hour period included within the period required under Regulation .02B(29) of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>The animal is inhumanely suffering.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Surrender of Animals. A person may not fail or refuse to surrender a dead or live animal for quarantine, humane killing, or rabies testing as required in this chapter when demand is made by written order of the local health officer or the Public Health Veterinarian.</text> </paragraph> <paragraph num="G."> <text>The police, sheriff, or animal control authority staff shall enforce all written orders of the local health officer or Public Health Veterinarian issued pursuant to this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Area Quarantine."> <paragraph num="A."> <text>If rabies is known to exist within an area, the Public Health Veterinarian, in conjunction with the Maryland Department of Agriculture, may establish an area quarantine for rabies, define the boundaries of the quarantine area, and specify the species of animal or animals subject to the quarantine.</text> </paragraph> <paragraph num="B."> <text>The owner or custodian of an animal subject to the area quarantine shall keep the animal in quarantine on the premises of the owner or custodian at all times until the area quarantine is terminated in writing by the Public Health Veterinarian, in conjunction with the Maryland Department of Agriculture.</text> </paragraph> <paragraph num="C."> <text>A person may not bring an animal subject to an area quarantine into or out of the quarantine area without the written permission of the Public Health Veterinarian and the Department of Agriculture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Laboratory Testing."> <paragraph num="A."> <text>A local health officer or local animal control authority shall submit rabies specimens for laboratory testing.</text> </paragraph> <paragraph num="B."> <text>The director of the rabies testing laboratory shall promptly forward a copy of the results of a rabies examination to the:</text> <paragraph num="(1)"> <text>Local health officer;</text> </paragraph> <paragraph num="(2)"> <text>Individual that originally submitted the specimen to the laboratory from the local animal control authority; and</text> </paragraph> <paragraph num="(3)"> <text>Public Health Veterinarian.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The director of the rabies testing laboratory shall promptly report by telephone to the local health officer a positive rabies finding on a specimen from an animal that has been involved in bite or non-bite contact with an individual.</text> </paragraph> <paragraph num="D."> <text>After receiving results of a positive finding of rabies, the local health officer shall notify the attending physician or attending veterinarian by telephone.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Vaccination of Animals."> <paragraph num="A."> <text>An owner or custodian of a dog, cat, or ferret shall have that animal adequately vaccinated against rabies by the time the dog, cat, or ferret is 4 months old.</text> </paragraph> <paragraph num="B."> <text>Vaccination Documentation.</text> <paragraph num="(1)"> <text>Except for a local animal control authority, an owner or custodian of an animal required to be licensed or registered shall have the animal adequately vaccinated and shall obtain a valid rabies vaccination certificate on the form specified by the Department. The certificate shall be completed and signed by a Maryland-licensed veterinarian or, in the case of public antirabies clinics, the certificate may be issued under the authority of the Public Health Veterinarian, documenting that the animal has been adequately vaccinated against rabies for the period of time covered by the rabies vaccination.</text> </paragraph> <paragraph num="(2)"> <text>Except for a kennel licensed by the local animal control authority as a boarding kennel, an owner or operator of a kennel shall present, upon the request of the local health officer, Public Health Veterinarian, or local animal control authority, a valid rabies vaccination certificate for each dog, cat, or ferret:</text> <paragraph num="(a)"> <text>Owned or kept by the kennel; and</text> </paragraph> <paragraph num="(b)"> <text>That is 4 months old or older.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Public Health Veterinarian may delay temporarily or indefinitely the rabies vaccination requirement for certain dogs, cats, or ferrets in the interest of public safety or for medical determinations or research.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless the Public Health Veterinarian has authorized a delay in vaccination, a local animal control authority may not license or register a dog, cat, or ferret without verifying the rabies vaccination status as documented by a current rabies vaccination certificate.</text> </paragraph> <paragraph num="D."> <text>Vaccination Certificates.</text> <paragraph num="(1)"> <text>A vaccine manufacturer shall issue the official National Association of State Public Health Veterinarians (NASPHV) Form 51, Rabies Vaccination Certificate, or an equivalent form.</text> </paragraph> <paragraph num="(2)"> <text>A veterinarian shall administer rabies vaccine to an animal in accordance with the specifications on the vaccine and recommendations for immunization procedures, such as the current Compendium of Animal Rabies Prevention and Control.</text> </paragraph> <paragraph num="(3)"> <text>The veterinarian administering rabies vaccine to an animal shall:</text> <paragraph num="(a)"> <text>Complete the NASPHV Form 51, or an equivalent form, containing the:</text> <paragraph num="(i)"> <text>Vaccine manufacturer and lot or serial number;</text> </paragraph> <paragraph num="(ii)"> <text>Date the vaccine was given;</text> </paragraph> <paragraph num="(iii)"> <text>Date the next vaccination is due by;</text> </paragraph> <paragraph num="(iv)"> <text>Signature of the veterinarian and the date the rabies certificate was signed;</text> </paragraph> <paragraph num="(v)"> <text>Veterinarian’s name, address, telephone number, and veterinary license number legibly stamped, typed, or printed;</text> </paragraph> <paragraph num="(vi)"> <text>Owner’s name, address, and telephone number;</text> </paragraph> <paragraph num="(vii)"> <text>Rabies tag number; and</text> </paragraph> <paragraph num="(viii)"> <text>Animal’s species, age, weight, predominant breed, and color; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>When vaccine is administered at public antirabies clinics, the local clinic staff shall complete the NASPHV Form 51, or an equivalent form, as directed by the Public Health Veterinarian and provide a copy to the local health officer and the animal owner.</text> </paragraph> <paragraph num="(5)"> <text>A veterinarian administering rabies vaccine shall maintain copies of vaccination certificates by tag number for a minimum of 5 years following the vaccination of an animal.</text> </paragraph> <paragraph num="(6)"> <text>An owner or custodian may use the vaccination certificate as proof of vaccination and shall provide it to police, the animal control authority, or health officials upon request.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Vaccination Procedures.</text> <paragraph num="(1)"> <text>A licensed veterinarian may select a rabies vaccine of the veterinarian’s choice and use procedures for administering it that are consistent with the recommendations of NASPHV, the United States Department of Agriculture, and the Compendium of Animal Rabies Prevention and Control.</text> </paragraph> <paragraph num="(2)"> <text>The Public Health Veterinarian shall select the vaccine or vaccines to be used in public clinics according to Department procedures.</text> </paragraph> <paragraph num="(3)"> <text>The Public Health Veterinarian may require specified lots of vaccine to be tested for potency, safety, and contamination as a prerequisite to their use.</text> </paragraph> <paragraph num="(4)"> <text>Except for veterinary staffing, the public antirabies clinics and the local health officer shall determine all administrative procedures for public antirabies clinics in keeping with the requirements of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>A vendor of rabies vaccine for animal use shall supply vaccine only to a veterinary biologic supply firm, a Maryland-licensed veterinarian, or the Public Health Veterinarian.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Rabies Tags.</text> <paragraph num="(1)"> <text>The Public Health Veterinarian shall specify annually the size, shape, and color of the rabies tag to be issued by veterinarians and public antirabies clinics.</text> </paragraph> <paragraph num="(2)"> <text>Public antirabies clinics and veterinarians who provide rabies vaccination services to dogs, cats, and ferrets shall promptly issue to the owner of each vaccinated animal a rabies certificate, tag, and s-shaped metal link for attaching the tag on the animal's collar.</text> </paragraph> <paragraph num="(3)"> <text>The local health officer shall order rabies tags through the Public Health Veterinarian for use in public antirabies clinics.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Antirabies Clinics.</text> <paragraph num="(1)"> <text>In conjunction with the Department, each local health department shall provide for low-cost, self-financing, antirabies clinics for animals in each county and Baltimore City.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall assure that at least two clinics are offered annually with at least one to be held between April 1 and July 1 at dates and locations determined by the local health department.</text> </paragraph> <paragraph num="(3)"> <text>The Public Health Veterinarian shall establish in writing the vaccination procedures to be used at the clinics and distribute these procedures to the local health officers.</text> </paragraph> <paragraph num="(4)"> <text>The local health departments may establish fees sufficient to cover the costs of operating the clinics.</text> </paragraph> <paragraph num="(5)"> <text>The local health officer shall report, in the manner specified by the Public Health Veterinarian, data concerning animals vaccinated at each clinic and the related costs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Importation of Animals."> <paragraph num="A."> <text>Except as provided in §§B and I of this regulation, the owner or custodian of a dog, cat, or ferret 4 months old or older to be imported into the State for any purpose shall forward a certificate, issued by a licensed veterinarian, to the Public Health Veterinarian, within 10 days of the animal's arrival in the State, that:</text> <paragraph num="(1)"> <text>Describes the dog, cat, or ferret, documenting that it was vaccinated against rabies;</text> </paragraph> <paragraph num="(2)"> <text>Lists the manufacturer or brand of vaccine used;</text> </paragraph> <paragraph num="(3)"> <text>Lists the date or dates the vaccine was given;</text> </paragraph> <paragraph num="(4)"> <text>Documents that the animal is adequately vaccinated; and</text> </paragraph> <paragraph num="(5)"> <text>Documents that the most recent dose of vaccine was given more than 30 days before the date the animal arrived in the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided in §I of this regulation, the owner or custodian of a dog, cat, or ferret brought into the State for a period of less than 30 days is exempt from the requirement to forward a certificate to the Public Health Veterinarian as specified in §A of this regulation, if a copy of a certificate signed by a licensed veterinarian can be presented to the local health officer immediately when requested.</text> </paragraph> <paragraph num="C."> <text>The local animal control authority may accept the certificate specified in §A of this regulation as proof of vaccination for licensing or registration purposes for the period specified on the certificate or 12 months, whichever period is shorter.</text> </paragraph> <paragraph num="D."> <text>The Public Health Veterinarian or the local health officer may order the owner or custodian of a dog, cat, or ferret brought into Maryland in violation of the provisions of this regulation to return the animal immediately to its point of origin at the owner's expense.</text> </paragraph> <paragraph num="E."> <text>If the local animal control authority is unable to locate an individual who will assume fiscal responsibility for an animal under an order to be returned to the point of origin within 48 hours of the issuance of the order, the authority may deem the animal abandoned and humanely kill it or place it for adoption.</text> </paragraph> <paragraph num="F."> <text>Research facilities and licensed dealers, as defined in 7 U.S.C. §2132 and 9 CFR 1.1 and 2.7, are exempt from §§D and E of this regulation when importing dogs, cats, and ferrets.</text> </paragraph> <paragraph num="G."> <text>The Secretary shall establish, in consultation with the Maryland Department of Agriculture, rabies control requirements for the importing and keeping of animals other than dogs, cats, and ferrets, such as livestock, wildlife, zoo animals, and exotic animals.</text> </paragraph> <paragraph num="H."> <text>The Secretary, with the agreement of the Secretary of Agriculture and the Secretary of Natural Resources, shall prohibit the importation of certain animals or species of animals from areas inside or outside the United States that are known to have a high prevalence of rabies and the animals subject to the ban are judged to present an unacceptable risk of rabies infection in humans or animals.</text> </paragraph> <paragraph num="I."> <text>The Public Health Veterinarian may waive the requirements of §§A and B of this regulation if the importation of the animal poses no risk to the public health or safety.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Permits Required for Keeping Certain Animals."> <text>The Secretary shall require a person to obtain from the Public Health Veterinarian a permit for keeping certain animals or species of animals if the Secretary has determined that these animals or species of animals represent a substantial threat of rabies to humans.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Disposition of Animals by Animal Shelters, Pounds, or Veterinarians."> <paragraph num="A."> <text>The owner or custodian of an animal who surrenders the animal to an animal shelter, pound, or veterinarian for the purpose of having the animal humanely killed or for the purpose of offering the animal for adoption shall certify in writing, under penalty of perjury, that the animal:</text> <paragraph num="(1)"> <text>If a dog, cat, ferret, or livestock, has not had bite or non-bite contact with an individual within the previous 10 days; or</text> </paragraph> <paragraph num="(2)"> <text>If a wild animal, has not had bite or non-bite contact with an individual within the previous 30 days.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided in §C of this regulation, if the animal has had bite or non-bite contact with an individual within the time periods specified in §A of this regulation, the animal shelter, pound, or veterinarian shall:</text> <paragraph num="(1)"> <text>If the animal is a dog, cat, ferret, or livestock, offer the owner or custodian, the option of:</text> <paragraph num="(a)"> <text>Quarantining the animal for 10 calendar days at the owner’s or custodian’s expense; or</text> </paragraph> <paragraph num="(b)"> <text>Humanely killing the animal and submitting the head for rabies testing; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the animal is a wild animal, immediately humanely kill the animal and submit its head for rabies testing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Public Health Veterinarian may waive the requirements of §B of this regulation if it is determined that the public health is not threatened.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Penalty."> <text>A person refusing or failing to comply with the provisions of this chapter, or with the orders or directives of the local health officer, the State Epidemiologist, or the Public Health Veterinarian as provided by this chapter, shall be guilty of a misdemeanor and, upon conviction, subject to a fine of not more than $500 for each offense.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 18-312—18-320, and 18-604, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 27, 1977 (4:9 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History">Preface and Regulation .01 recodified to Regulation .01 and Regulation .01-1, respectively, in July 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective February 14, 1994 (21:3 Md. R. 193)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.14 repealed and new Regulations .01—.14 adopted effective November 16, 1998 (25:23 Md. R. 1696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); emergency status extended at 35:9 Md. R. 892; amended permanently effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 15, 2016 (43:3 Md. R. 272); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, D amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E repealed effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, D amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); emergency status extended at 35:9 Md. R. 892; amended permanently effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective September 14, 2015 (42:18 Md. R. 1174); February 27, 2017 (44:4 Md. R. 253)</annotation> </annotations> </chapter> <chapter num="03" heading="ImmuNet"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs ImmuNet, a computer-based registry of immunizations, as established in Health-General Article, §18-109, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Authorized user” means:</text> <paragraph num="(a)"> <text>A child care facility;</text> </paragraph> <paragraph num="(b)"> <text>A health care provider;</text> </paragraph> <paragraph num="(c)"> <text>A health insurer;</text> </paragraph> <paragraph num="(d)"> <text>A health maintenance organization;</text> </paragraph> <paragraph num="(e)"> <text>An institution of higher learning;</text> </paragraph> <paragraph num="(f)"> <text>A local health department;</text> </paragraph> <paragraph num="(g)"> <text>A long-term care facility;</text> </paragraph> <paragraph num="(h)"> <text>A managed care organization;</text> </paragraph> <paragraph num="(i)"> <text>A nonprofit health service plan;</text> </paragraph> <paragraph num="(j)"> <text>A patient;</text> </paragraph> <paragraph num="(k)"> <text>A pharmacist authorized to administer vaccinations in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(l)"> <text>A school;</text> </paragraph> <paragraph num="(m)"> <text>A school-based health center;</text> </paragraph> <paragraph num="(n)"> <text>In the case of a minor child, a parent or guardian; and</text> </paragraph> <paragraph num="(o)"> <text>Any other authorized user designated by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“ImmuNet” means a computerized information and reminder system to:</text> <paragraph num="(a)"> <text>Improve the timely and appropriate delivery of immunizations;</text> </paragraph> <paragraph num="(b)"> <text>Provide a coordinated network for reminder notices when immunizations are due;</text> </paragraph> <paragraph num="(c)"> <text>Provide and collect information to be shared by authorized users; and</text> </paragraph> <paragraph num="(d)"> <text>Provide a quality indicator for the insurers’ health care provider practices and public health purposes.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Refusal to permit disclosure of information” means the right of an individual or the parent or guardian of a minor to prevent disclosure to authorized users of individual identifiable information that was reported to ImmuNet.</text> </paragraph> <paragraph num="(5)"> <text>Regional Registry.</text> <paragraph num="(a)"> <text>“Regional registry” means a database that contains immunization information for individuals residing in an area of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Regional registry” includes an immunization database or registry maintained and operated by a local health department.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Vaccine information statement (VIS)” means a document that:</text> <paragraph num="(a)"> <text>Is created and updated by the U.S. Centers for Disease Control and Prevention; and</text> </paragraph> <paragraph num="(b)"> <text>Relates:</text> <paragraph num="(i)"> <text>The purpose of specific vaccines;</text> </paragraph> <paragraph num="(ii)"> <text>Schedules of administration; and</text> </paragraph> <paragraph num="(iii)"> <text>Possible adverse reactions to specific vaccines.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Administration of ImmuNet."> <paragraph num="A."> <text>The Department shall support and administer ImmuNet.</text> </paragraph> <paragraph num="B."> <text>The Department may enter or edit information contained in ImmuNet.</text> </paragraph> <paragraph num="C."> <text>ImmuNet is subject to the security and reliability standards set forth in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Department shall make available to authorized users and to the general public all forms relevant to ImmuNet, such as the:</text> <paragraph num="(1)"> <text>User agreement;</text> </paragraph> <paragraph num="(2)"> <text>Refusal to Permit Disclosure of Information form; and</text> </paragraph> <paragraph num="(3)"> <text>Statement of Reactivation of Participation in ImmuNet form.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Information Reported to ImmuNet."> <paragraph num="A."> <text>The Department shall enter the following information from each birth certificate registered in Maryland:</text> <paragraph num="(1)"> <text>Child’s:</text> <paragraph num="(a)"> <text>First, middle, and last name;</text> </paragraph> <paragraph num="(b)"> <text>Date of birth;</text> </paragraph> <paragraph num="(c)"> <text>Sex; and</text> </paragraph> <paragraph num="(d)"> <text>Current or last known address; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Child’s mother’s:</text> <paragraph num="(a)"> <text>First and middle names;</text> </paragraph> <paragraph num="(b)"> <text>Maiden Name if applicable; and</text> </paragraph> <paragraph num="(c)"> <text>Current last name.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Following the administration of a vaccine to an individual residing in Maryland, the health care provider who administered the vaccine may enter the following information to ImmuNet:</text> <paragraph num="(1)"> <text>Patient’s:</text> <paragraph num="(a)"> <text>First, middle, and last name;</text> </paragraph> <paragraph num="(b)"> <text>Date of birth;</text> </paragraph> <paragraph num="(c)"> <text>Sex;</text> </paragraph> <paragraph num="(d)"> <text>Birth state and country;</text> </paragraph> <paragraph num="(e)"> <text>Current or last known address;</text> </paragraph> <paragraph num="(f)"> <text>If the patient is a minor, the name of the parent or guardian;</text> </paragraph> <paragraph num="(g)"> <text>Last four digits of Social Security number, if available; and</text> </paragraph> <paragraph num="(h)"> <text>Medicaid number, if available and applicable;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patient’s mother’s:</text> <paragraph num="(a)"> <text>First and middle names;</text> </paragraph> <paragraph num="(b)"> <text>Maiden name, if applicable; and</text> </paragraph> <paragraph num="(c)"> <text>Current last name;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For each vaccine administered:</text> <paragraph num="(a)"> <text>Antigen type;</text> </paragraph> <paragraph num="(b)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(c)"> <text>Expiration date;</text> </paragraph> <paragraph num="(d)"> <text>Lot number;</text> </paragraph> <paragraph num="(e)"> <text>Date VIS provided to patient;</text> </paragraph> <paragraph num="(f)"> <text>VIS date; and</text> </paragraph> <paragraph num="(g)"> <text>Date of administration;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Contraindication, adverse event, and exemption information for the patient, including:</text> <paragraph num="(a)"> <text>A medical contraindication or adverse event to the administration of one or more vaccines;</text> </paragraph> <paragraph num="(b)"> <text>Whether the contraindication is permanent or temporary and, if temporary, the date after which the contraindication will no longer exist or needs to be reassessed; and</text> </paragraph> <paragraph num="(c)"> <text>An objection to immunization based on a bona fide religious belief and practice;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Other medical information pertaining to vaccine-preventable diseases, including serologic test results;</text> </paragraph> <paragraph num="(6)"> <text>Other information designated by the U.S. Centers for Disease Control and Prevention as Immunization Information System Required Core Data Elements; and</text> </paragraph> <paragraph num="(7)"> <text>Other information designated by the Secretary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Correction of Inaccurate Information. A patient or a parent or a guardian of a minor patient whose immunization information is entered into ImmuNet may contact the Department to:</text> <paragraph num="(1)"> <text>View the information; and</text> </paragraph> <paragraph num="(2)"> <text>Provide information to correct any inaccuracies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="User Agreement."> <paragraph num="A."> <text>An authorized user who wishes to obtain information from ImmuNet shall enter into a user agreement with the Department for the purpose of protecting the confidentiality and security of ImmuNet information.</text> </paragraph> <paragraph num="B."> <text>The user agreement shall include but not be limited to the:</text> <paragraph num="(1)"> <text>Functions that may be performed by an authorized user of ImmuNet;</text> </paragraph> <paragraph num="(2)"> <text>Authorized uses of ImmuNet information as set forth in Health-General Article, §18-109(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Prohibitive uses of ImmuNet information as set forth in Health-General Article, §18-109(f), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Basic practices for safeguarding confidential information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Authorized users shall request the renewal of the user agreement on an annual basis.</text> </paragraph> <paragraph num="D."> <text>Authorized User Functions.</text> <paragraph num="(1)"> <text>An authorized user who has signed a user agreement may obtain the following information about an individual from ImmuNet:</text> <paragraph num="(a)"> <text>First, middle, and last name;</text> </paragraph> <paragraph num="(b)"> <text>Date of birth;</text> </paragraph> <paragraph num="(c)"> <text>Address;</text> </paragraph> <paragraph num="(d)"> <text>Telephone number;</text> </paragraph> <paragraph num="(e)"> <text>In the case of a minor child, the name of the parent or guardian;</text> </paragraph> <paragraph num="(f)"> <text>Immunizations given;</text> </paragraph> <paragraph num="(g)"> <text>Immunization dates;</text> </paragraph> <paragraph num="(h)"> <text>Contraindication, adverse event, and exemption information; and</text> </paragraph> <paragraph num="(i)"> <text>Other medical information pertaining to vaccine-preventable diseases, including serologic test results.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An authorized user that is a health care provider, local health department, long-term care facility, or school-based health center that administers immunizations may:</text> <paragraph num="(a)"> <text>Enter information into ImmuNet directly from medical records that are in the authorized user’s possession; and</text> </paragraph> <paragraph num="(b)"> <text>Edit information the authorized user has entered into ImmuNet.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An authorized user who is a patient or a parent or guardian of a minor may view the patient’s or the minor patient’s ImmuNet information without signing a user agreement by requesting the information from the patient’s or minor’s immunization provider or the Department.</text> </paragraph> <paragraph num="(4)"> <text>With approval from the Department, the following authorized users may enter information into ImmuNet:</text> <paragraph num="(a)"> <text>A child care facility;</text> </paragraph> <paragraph num="(b)"> <text>A health insurer;</text> </paragraph> <paragraph num="(c)"> <text>A health maintenance organization;</text> </paragraph> <paragraph num="(d)"> <text>An institution of higher learning;</text> </paragraph> <paragraph num="(e)"> <text>A managed care organization;</text> </paragraph> <paragraph num="(f)"> <text>A nonprofit health service plan; and</text> </paragraph> <paragraph num="(g)"> <text>A school.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Refusal and Reactivation."> <paragraph num="A."> <text>An individual or a parent or guardian of a minor child who has received an immunization may at any time prohibit information in ImmuNet from being disclosed to authorized users by providing to the Department a signed and dated Refusal to Permit Disclosure of Information form.</text> </paragraph> <paragraph num="B."> <text>An individual or a parent or guardian of a minor who has submitted a Refusal to Permit Disclosure of Information form may allow information in ImmuNet to be disclosed by submitting to the Department a signed and dated written Statement of Reactivation of Participation in ImmuNet form.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Permissible Use of ImmuNet Information."> <text>Information in ImmuNet may be used by authorized users for the following purposes:</text> <paragraph num="A."> <text>To provide coordinated immunization services, including sending reminder notices to individuals who need immunizations;</text> </paragraph> <paragraph num="B."> <text>To obtain an individual immunization history;</text> </paragraph> <paragraph num="C."> <text>To identify geographic areas or population groups who are underimmunized;</text> </paragraph> <paragraph num="D."> <text>To compile aggregate information and distribute statistical reports on the status of immunizations in geographic areas and population groups;</text> </paragraph> <paragraph num="E."> <text>To assist in the management of State and local immunization programs;</text> </paragraph> <paragraph num="F."> <text>To monitor the safety of vaccines;</text> </paragraph> <paragraph num="G."> <text>To assess compliance with immunization requirements by monitoring admissions to:</text> <paragraph num="(1)"> <text>Schools;</text> </paragraph> <paragraph num="(2)"> <text>Institutions of higher learning; and</text> </paragraph> <paragraph num="(3)"> <text>Child care facilities; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>For any other purpose that the Secretary deems necessary to prevent the spread of communicable diseases or assess the safety or effectiveness of vaccines in accordance with Health-General Article, §18-109(c), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Regional and Other State Immunization Registries."> <paragraph num="A."> <text>A regional registry shall submit to ImmuNet all immunization information on Maryland residents within 14 calendar days of receipt of the information.</text> </paragraph> <paragraph num="B."> <text>If the confidentiality of records of Maryland citizens is protected, the Department may enter into a collaborative agreement with other states for the purpose of sharing immunization information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Security and Reliability Standards."> <paragraph num="A."> <text>The Department shall maintain ImmuNet in accordance with system security requirements for federal information processing systems, including National Institute of Standards and Technology (NIST) 800-53 Special Publication, and prevailing agency information technology security policy standards and requirements.</text> </paragraph> <paragraph num="B."> <text>ImmuNet Security.</text> <paragraph num="(1)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Maintain ImmuNet information on a server protected by a firewall; and</text> </paragraph> <paragraph num="(b)"> <text>Encrypt information traveling to and from authorized users.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall maintain encryption keys in a secure location.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-109; Health Occupations Article, §12-508; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 27, 2015 (42:8 Md. R. 607)</annotation> </annotations> </chapter> <chapter num="04" heading="School Health Services and Required Immunizations Before Entry into School"> <regulation prefix="Regulation" num=".01" heading="School Health Services."> <text>The local health department shall cooperate with the local school system in implementing the School Health Services regulations found in COMAR 13A.05.05.05—15.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Health officer” means the health officer in each of the 23 counties of Maryland and the Commissioner of Health in Baltimore City, the designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(2)"> <text>“Preschool program” means a program that enrolls children in an educational program below the level of kindergarten.</text> </paragraph> <paragraph num="(3)"> <text>“Regulated child care program” means:</text> <paragraph num="(a)"> <text>A family day care provider registered pursuant to COMAR 07.04.01;</text> </paragraph> <paragraph num="(b)"> <text>The operator of a child care center licensed pursuant to COMAR 07.04.02; or</text> </paragraph> <paragraph num="(c)"> <text>The operator of a child care facility issued a letter of compliance pursuant to COMAR 07.04.05.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Required Immunizations."> <paragraph num="A."> <text>Except as provided in Regulations .04—.06 of this chapter, a preschool or school principal or other person in charge of a preschool or school, public or private, may not knowingly admit a student to or retain a student in a:</text> <paragraph num="(1)"> <text>Preschool program unless the student's parent or guardian has furnished evidence of age-appropriate immunity against Haemophilus influenzae, type b, and pneumococcal disease;</text> </paragraph> <paragraph num="(2)"> <text>Preschool program or kindergarten through the second grade of school unless the student's parent or guardian has furnished evidence of age-appropriate immunity against pertussis; and</text> </paragraph> <paragraph num="(3)"> <text>Preschool program or kindergarten through the 12th grade unless the student's parent or guardian has furnished evidence of age-appropriate immunity against:</text> <paragraph num="(a)"> <text>Tetanus;</text> </paragraph> <paragraph num="(b)"> <text>Diphtheria;</text> </paragraph> <paragraph num="(c)"> <text>Poliomyelitis;</text> </paragraph> <paragraph num="(d)"> <text>Measles (rubeola);</text> </paragraph> <paragraph num="(e)"> <text>Mumps;</text> </paragraph> <paragraph num="(f)"> <text>Rubella;</text> </paragraph> <paragraph num="(g)"> <text>Hepatitis B;</text> </paragraph> <paragraph num="(h)"> <text>Varicella;</text> </paragraph> <paragraph num="(i)"> <text>Meningitis; and</text> </paragraph> <paragraph num="(j)"> <text>Tetanus-diphtheria-acellular pertussis acquired through a Tetanus-diphtheria-acellular pertussis (Tdap) vaccine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided in Regulations .04—.06 of this chapter, a parent or guardian shall provide evidence of age-appropriate immunity to the preschool or school authority on a form provided by the Secretary or on a printed or computer-generated form that lists the following:</text> <paragraph num="(1)"> <text>Name of the student;</text> </paragraph> <paragraph num="(2)"> <text>Date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Name and address of parent or guardian;</text> </paragraph> <paragraph num="(4)"> <text>Complete history of vaccines received with month, day, and year of each vaccine dose; and</text> </paragraph> <paragraph num="(5)"> <text>Signature, title, and date of the physician, health official, school official, or regulated child care program providing the information on the form.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in Regulations .04—.06 of this chapter and §A(3) of this regulation, a student shall obtain immunizations in accordance with the schedule of immunizations recommended by the Medical and Chirurgical Faculty of Maryland and the Secretary, as set forth in §D of this regulation and as required to be implemented in §§E and F of this regulation.</text> </paragraph> <paragraph num="D."> <text>Schedule of Immunizations.</text> <paragraph num="(1)"> <text>Student in Preschool. In order for the immunization status of a student enrolled in a preschool to be complete, the student's parent or guardian shall provide proof of the following doses of immunizations:</text> </paragraph> <paragraph num="(2)"> <text>Student in Kindergarten Through 12th Grade.</text> <paragraph num="(a)"> <text>In order for the immunization status of a student enrolled in kindergarten through 12th grade to be complete, the student's parent or guardian shall provide proof of the immunizations or immunity as outlined in §D(2)(b)—(l) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>Diphtheria.</text> <paragraph num="(i)"> <text>Four doses of diphtheria immunization vaccine are required for a student younger than 7 years old; and</text> </paragraph> <paragraph num="(ii)"> <text>Three doses of diphtheria immunization vaccine are required for a student 7 years old or older.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Tetanus.</text> <paragraph num="(i)"> <text>Four doses of tetanus immunization vaccine are required for a student younger than 7 years old; and</text> </paragraph> <paragraph num="(ii)"> <text>Three doses of tetanus immunization vaccine are required for a student 7 years old or older.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Pertussis. Four doses of pertussis immunization vaccine are required for a student younger than 7 years old.</text> </paragraph> <paragraph num="(e)"> <text>Poliomyelitis (Oral or Injectable).</text> <paragraph num="(i)"> <text>Three doses of poliomyelitis immunization vaccine are required for a student younger than 18 years old; or</text> </paragraph> <paragraph num="(ii)"> <text>Proof of immunity from poliomyelitis by blood test is required for a student younger than 18 years old.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Rubella.</text> <paragraph num="(i)"> <text>Two doses of live rubella virus vaccine are required when the student is 1 year old or older; or</text> </paragraph> <paragraph num="(ii)"> <text>Proof of immunity from rubella by blood test is required when the student is 1 year old or older.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Measles (rubeola).</text> <paragraph num="(i)"> <text>Two doses of live measles (rubeola) virus vaccine are required when the student is 1 year old or older; or</text> </paragraph> <paragraph num="(ii)"> <text>Proof of immunity from rubeola by blood test is required when the student is 1 year old or older.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Mumps.</text> <paragraph num="(i)"> <text>Two doses of live mumps virus vaccine are required when the student is 1 year old or older; or</text> </paragraph> <paragraph num="(ii)"> <text>Proof of immunity from mumps by blood test is required when the student is 1 year old or older.</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Hepatitis B.</text> <paragraph num="(i)"> <text>Three doses of hepatitis B vaccine are required; or</text> </paragraph> <paragraph num="(ii)"> <text>Proof of immunity from hepatitis B by blood test is required.</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Varicella.</text> <paragraph num="(i)"> <text>All doses of varicella vaccine shall be given when the student is 1 year old or older.</text> </paragraph> <paragraph num="(ii)"> <text>Per the schedule of implementation in §E(1) of this regulation and except as provided in §D(2)(j)(iii) of this regulation, one dose of live varicella vaccine is required for a student younger than 13 years old, or two doses of live varicella vaccine are required for a student 13 years old or older, if the student does not have proof of vaccination against varicella at an age younger than 13 years old.</text> </paragraph> <paragraph num="(iii)"> <text>Proof of immunity from varicella by blood test or by medical diagnosis indicated by month and year of diagnosis may be provided instead of meeting the requirements of §D(2)(j)(ii) or (iv) of this regulation.</text> </paragraph> <paragraph num="(iv)"> <text>Per the schedule of implementation in §E(2) of this regulation and except as provided in §D(2)(j)(iii) of this regulation, two doses of live varicella vaccine are required.</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Meningococcal. One dose of meningococcal vaccine is required per the schedule of implementation in §F of this regulation.</text> </paragraph> <paragraph num="(l)"> <text>Tetanus-diphtheria-acellular pertussis (Tdap). One dose of Tetanus-diphtheria-acellular pertussis (Tdap) immunization vaccine is required per the schedule of implementation in §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Record Review for Student in Preschool Through 12th Grade. A preschool or school, public or private, may count as valid, vaccine doses administered less than or equal to 4 days before the minimum interval or age.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Schedule of Implementation: Varicella Effective Immunization Dates for a Student in Kindergarten Through 12th Grade.</text> <paragraph num="(1)"> <text>As set forth in §E(2) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the school that the student:</text> <paragraph num="(a)"> <text>Has received age appropriate vaccination with varicella vaccine; or</text> </paragraph> <paragraph num="(b)"> <text>Is immune to varicella by providing the results of a blood test or a medical diagnosis indicated by month and year of diagnosis.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>One-Dose Requirement Immunization Dates for a Student in Kindergarten Through 12th Grade.</text> </paragraph> <paragraph num="(3)"> <text>As set forth in §E(4) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the kindergarten or school that the student:</text> <paragraph num="(a)"> <text>Has received two doses of varicella vaccine; or</text> </paragraph> <paragraph num="(b)"> <text>Is immune to varicella by providing the results of a blood test or a medical diagnosis indicated by month and year of diagnosis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Two-Dose Requirement Immunization Dates for a Student in Kindergarten Through 12th Grade.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Schedule of Implementation: Meningococcal and Tetanus-diphtheria-acellular pertussis (Tdap) Effective Immunization Dates for a Student in Preschool Through 12th Grade.</text> <paragraph num="(1)"> <text>As set forth in §F(2) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the preschool or school that the student has received one dose of:</text> <paragraph num="(a)"> <text>Meningococcal immunization vaccine; and</text> </paragraph> <paragraph num="(b)"> <text>Tetanus-diphtheria-acellular pertussis (Tdap) immunization vaccine.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Immunization Dates for a Student in 7th Through 12th Grade.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Medical Contraindications."> <paragraph num="A."> <text>The requirements of Regulation .03 of this chapter do not apply to a student who presents a licensed physician's or health officer's written statement that the student's immunization against a disease in Regulation .03 of this chapter is medically contraindicated.</text> </paragraph> <paragraph num="B."> <text>The physician or health officer shall indicate in the statement presented under §A of this regulation whether the contraindication is:</text> <paragraph num="(1)"> <text>Permanent; or</text> </paragraph> <paragraph num="(2)"> <text>Temporary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the contraindication is temporary:</text> <paragraph num="(1)"> <text>The physician or health officer shall provide in the statement presented under §A of this regulation an estimate of when the immunization may be obtained by the student; and</text> </paragraph> <paragraph num="(2)"> <text>The student's parent or guardian shall furnish to the preschool or school evidence of the completion of the immunization in accordance with the estimate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A preschool or school, public or private, shall maintain a current list of all students enrolled who have an exemption to immunizations on medical grounds.</text> </paragraph> <paragraph num="E."> <text>Annually, by November 15, a preschool or school, public or private, shall report to the Secretary of Health the number of students with a medical exemption enrolled in all grades.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Religious Exemption."> <paragraph num="A."> <text>Using the form provided by the Maryland Department of Health, a student whose parent or guardian objects to immunization on the ground that the immunization conflicts with the parent's or guardian's bona fide religious beliefs and practices is exempt from the requirement to present a physician's certificate of immunization in order that the student be admitted to school.</text> </paragraph> <paragraph num="B."> <text>The exemption allowed under §A of this regulation does not apply when the Secretary declares an emergency or epidemic of disease.</text> </paragraph> <paragraph num="C."> <text>A preschool or school, public or private, shall maintain a current list of all students enrolled who have an exemption to immunizations on religious grounds.</text> </paragraph> <paragraph num="D."> <text>Annually, by November 15th, a preschool or school, public or private, shall report to the Secretary of Health the number of students with a religious exemption enrolled in all grades.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Temporary Admission or Retention."> <paragraph num="A."> <text>Subject to the provisions of §B of this regulation, a preschool or school, public or private, shall temporarily admit a student to or retain a student in a preschool or school if:</text> <paragraph num="(1)"> <text>The student is homeless; or</text> </paragraph> <paragraph num="(2)"> <text>The student's parent or guardian is unable to provide proof of immunization pursuant to the requirements of Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order for a student to be temporarily admitted to or retained in a preschool or school, the student's parent or guardian shall present evidence of the student's appointment with a health care provider or local health department to:</text> <paragraph num="(1)"> <text>Receive a required immunization;</text> </paragraph> <paragraph num="(2)"> <text>Reconstruct a lost record; or</text> </paragraph> <paragraph num="(3)"> <text>Acquire evidence of age-appropriate immunity on a form provided by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The date of the appointment pursuant to §B of this regulation may not be later than 20 calendar days following the date the student was temporarily admitted or retained.</text> </paragraph> <paragraph num="D."> <text>A preschool or school, public or private, shall exclude from school a student who has been temporarily admitted or retained on the next school day following the appointment date if the student's parent or guardian fails to provide evidence of required immunizations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Vaccine Provision."> <paragraph num="A."> <text>A student may have an immunization administered by the student's personal physician.</text> </paragraph> <paragraph num="B."> <text>If a parent or guardian cannot obtain the service of a private physician, the parent or guardian of the student may take the student to the local health department for the immunizations.</text> </paragraph> <paragraph num="C."> <text>A local health department shall provide the immunization referenced in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Record Review."> <text>A preschool or school, public or private, shall make immunization records of students available for review by a health officer as needed to assure compliance with regulations or to ascertain the immunization status of students.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Report on New Students."> <text>Annually, by November 15, on a form provided by the Department, a preschool or school, public or private, shall provide the health officer of the jurisdiction where the school is located with an immunization report of students in preschool through 12th grade who are new to the school.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Responsible Agencies."> <text>The local superintendents of schools and the local health officers shall be responsible for carrying out the provisions of this chapter.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §7-403 and Health-General Article, §18-102(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective May 10, 1977 (4:11 Md. R. 865); emergency status extended at 4:22 Md. R. 1667 and 4:27 Md. R. 2095 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 16, 1977 (4:26 Md. R. 2024) and May 18, 1979 (6:10 Md. R. 842)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended and C adopted effective February 11, 1985 (12:3 Md. R. 245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 2, 1984 (10:26 Md. R. 2340)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.06.04.03 cited in Davis v. State, 294 Md. 370 (1982), in which the court held that “membership in a recognized religious group cannot be required as a condition of exemption from vaccination”. The religious exemption was held to contravene the Establishment Clause of the First Amendment and was therefore invalid. The immunization requirement itself was found to be severable and remains in force.</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 30, 1992 (19:6 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 22, 1996 (23:8 Md. R. 605); May 19, 1997 (24:10 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 repealed and new Regulations .01—.10 adopted effective November 24, 2005 (32:23 Md. R. 1826)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 12, 2012 (39:22 Md. R. 1428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 25, 2006 (33:19 Md. R. 1560)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted as an emergency provision effective March 20, 2007 (34:8 Md. R. 766); emergency provision expired</annotation> </annotations> </chapter> <chapter num="05" heading="Meningococcal Vaccination Requirements for Students in Institutions of Higher Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to meningococcal vaccination of individuals enrolled in institutions of higher education who are living in on-campus student housing.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Enrolled” means having registered for a credit or noncredit course.</text> </paragraph> <paragraph num="(2)"> <text>“Institution of higher education” means a school of post-secondary education that generally limits enrollment to graduates of secondary schools and awards degrees at the associate, baccalaureate, or graduate level.</text> </paragraph> <paragraph num="(3)"> <text>“Meningococcal vaccination” means receipt of the vaccine protecting against at least the four serogroups of A, C, Y, and W-135 of meningococcal disease within the preceding 5 years before the individual moves into on-campus student housing.</text> </paragraph> <paragraph num="(4)"> <text>“On-campus student housing” means housing provided to individuals, regardless of the fee, that is owned, rented, or contracted for and operated by an institution of higher education, or through written agreement, with an agent of the institution of higher education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Required Meningococcal Vaccination."> <text>Except as provided in Regulation .05 of this chapter, an individual enrolled in an institution of higher education living in on-campus student housing shall:</text> <paragraph num="A."> <text>Obtain a meningococcal vaccination; and</text> </paragraph> <paragraph num="B."> <text>Submit written documentation to the institution of higher education from a health care professional or clinic of receipt of a meningococcal vaccination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Notification of Required Meningococcal Vaccination."> <text>An institution of higher education shall:</text> <paragraph num="A."> <text>Inform an individual or the parent or guardian of an individual younger than 18 years old of the requirement for meningococcal vaccination at the time the individual:</text> <paragraph num="(1)"> <text>Is accepted for admission to an institution of higher education; or</text> </paragraph> <paragraph num="(2)"> <text>Registers for classes, if the individual is not required to apply for admission before registering for courses;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Include notice of the requirement for meningococcal vaccination in:</text> <paragraph num="(1)"> <text>Admission acceptance information;</text> </paragraph> <paragraph num="(2)"> <text>Student health-related information and materials;</text> </paragraph> <paragraph num="(3)"> <text>Resident life information and materials;</text> </paragraph> <paragraph num="(4)"> <text>The student handbook; and</text> </paragraph> <paragraph num="(5)"> <text>The college catalog; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provide detailed information to an individual who resides or may reside in on-campus student housing or the parent or guardian of an individual younger than 18 years old who resides or may reside in on-campus student housing concerning:</text> <paragraph num="(1)"> <text>The risks associated with meningococcal disease; and</text> </paragraph> <paragraph num="(2)"> <text>The availability and effectiveness of meningococcal vaccine.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Exemption from Meningococcal Vaccination Requirement."> <paragraph num="A."> <text>An individual 18 years old or older is exempt from the meningococcal vaccination requirement set forth at Regulation .03 of this chapter if the individual presents to the institution of higher education a signed written waiver as set forth in Regulation .06A of this chapter stating that the individual has:</text> <paragraph num="(1)"> <text>Received and reviewed the information specified in Regulation .04C of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Chosen not to obtain the meningococcal vaccination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual younger than 18 years old is exempt from the meningococcal vaccination requirement set forth at Regulation .03 of this chapter if a signed written waiver as set forth in Regulation .06B of this chapter is presented to the institution of higher education on behalf of the individual stating that a parent or guardian of the individual has:</text> <paragraph num="(1)"> <text>Received and reviewed the information specified in Regulation .04C of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Chosen not to have the individual obtain the meningococcal vaccination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Waiver Form."> <paragraph num="A."> <text>A waiver form for an individual 18 years old or older shall:</text> <paragraph num="(1)"> <text>State that the individual:</text> <paragraph num="(a)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Has received and reviewed the information provided by the institution of higher education on the risk of meningococcal disease and the availability and effectiveness of meningococcal vaccine; and</text> </paragraph> <paragraph num="(c)"> <text>Chooses to waive the receipt of meningococcal vaccine; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide spaces for the:</text> <paragraph num="(a)"> <text>Printed name of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Signature of the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Date.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A waiver form for an individual younger than 18 years old shall:</text> <paragraph num="(1)"> <text>State that:</text> <paragraph num="(a)"> <text>The individual is younger than 18 years old;</text> </paragraph> <paragraph num="(b)"> <text>The parent or guardian of the individual has received and reviewed the information provided by the institution of higher education on the risk of meningococcal disease and the availability and effectiveness of meningococcal vaccine; and</text> </paragraph> <paragraph num="(c)"> <text>The parent or guardian of the individual chooses to waive the receipt of meningococcal vaccine for the individual; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide spaces for the:</text> <paragraph num="(a)"> <text>Printed name of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Printed name of the parent or guardian;</text> </paragraph> <paragraph num="(c)"> <text>Signature of the parent or guardian; and</text> </paragraph> <paragraph num="(d)"> <text>Date.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment for Meningococcal Vaccination."> <text>Nothing in this chapter shall be construed to require an institution of higher education or a local public health agency to provide or pay for a meningococcal vaccination.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-102(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 12, 2001 (28:22 Md. R. 1937)</annotation> </annotations> </chapter> <chapter num="06" heading="Communicable Disease Prevention — Handling, Treatment, and Disposal of Special Medical Waste"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>Scope.</text> <paragraph num="(1)"> <text>Regulations .01—.03 apply to a person who generates and handles special medical waste or sharps.</text> </paragraph> <paragraph num="(2)"> <text>Regulations .01—.07 apply to a person who treats and disposes of special medical waste.</text> </paragraph> <paragraph num="(3)"> <text>This chapter does not apply to:</text> <paragraph num="(a)"> <text>Waste generated from veterinary practices that is governed by COMAR 15.14.03.02;</text> </paragraph> <paragraph num="(b)"> <text>Radioactive medical waste that is governed by COMAR 26.12.01.01;</text> </paragraph> <paragraph num="(c)"> <text>Remains of a dead human; and</text> </paragraph> <paragraph num="(d)"> <text>Fetuses and placentas that are released to a funeral director or a parent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Purpose. The purpose of this chapter is to minimize the possibility of disease transmission by establishing requirements for the handling, treatment, and disposal of special medical waste.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Anatomical material” means human or animal body parts, including tissues and organs.</text> </paragraph> <paragraph num="(2)"> <text>“Autoclaving” means a process by which an article is subjected to steam under pressure for documented periods of time, temperature, and pressure that render the article incapable of transmitting disease to humans.</text> </paragraph> <paragraph num="(3)"> <text>“Blood” means human blood, human blood components, and products made from human blood.</text> </paragraph> <paragraph num="(4)"> <text>Bloodborne Pathogens.</text> <paragraph num="(a)"> <text>“Bloodborne pathogens” means pathogenic microorganisms that:</text> <paragraph num="(i)"> <text>Are present in human blood; and</text> </paragraph> <paragraph num="(ii)"> <text>Can cause disease in humans.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Bloodborne pathogens” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Human immunodeficiency virus;</text> </paragraph> <paragraph num="(ii)"> <text>Hepatitis B virus; and</text> </paragraph> <paragraph num="(iii)"> <text>Hepatitis C virus.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Chemical disinfection” means the application of a chemical agent to an article, so that the article is rendered incapable of transmitting disease to humans.</text> </paragraph> <paragraph num="(6)"> <text>“Contaminated” means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.</text> </paragraph> <paragraph num="(7)"> <text>“Cremation” means the incineration of human or animal remains.</text> </paragraph> <paragraph num="(8)"> <text>“Decontamination” means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on an article to render the article incapable of transmitting disease to humans.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Disinfection” means a method that inactivates:</text> <paragraph num="(a)"> <text>Vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log reduction or greater; and</text> </paragraph> <paragraph num="(b)"> <text>Bacillus stearothermophilus spores and Bacillus subtilis spores at a 4 log reduction or greater.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Encapsulation” means a process by which:</text> <paragraph num="(a)"> <text>An article is sealed in a material that renders the article no longer recognizable or capable of transmitting disease to humans; and</text> </paragraph> <paragraph num="(b)"> <text>The sealed material:</text> <paragraph num="(i)"> <text>Is decontaminated or disinfected during the encapsulation process; and</text> </paragraph> <paragraph num="(ii)"> <text>Remains sealed under physical stress.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Incineration” means a process during which an article is burned:</text> <paragraph num="(a)"> <text>In an incinerator that meets the requirements of the Department of the Environment as set forth in COMAR 26.11.08;</text> </paragraph> <paragraph num="(b)"> <text>To carbonized or mineralized ash that is capable of disposal as solid waste; and</text> </paragraph> <paragraph num="(c)"> <text>So the article is rendered incapable of transmitting disease to humans.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Infectious agent” means an organism, including viral, rickettsial, bacterial, fungal, protozoal, or helminthic, that is capable of producing infection or infectious disease in humans.</text> </paragraph> <paragraph num="(14)"> <text>“Interment” means burial in a location, other than a landfill, that is approved for that purpose under applicable law.</text> </paragraph> <paragraph num="(15)"> <text>“Mechanical destruction” means a physical process that renders an article no longer recognizable as the original article.</text> </paragraph> <paragraph num="(16)"> <text>“Microbiological laboratory waste” means waste from a microbiological laboratory that:</text> <paragraph num="(a)"> <text>Contains an infectious agent; and</text> </paragraph> <paragraph num="(b)"> <text>Includes cultures and stocks of infectious agents and associated biologicals.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Occupational exposure” means skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials, that results from the performance of an employee's duties.</text> </paragraph> <paragraph num="(18)"> <text>“Other potentially infectious material” means:</text> <paragraph num="(a)"> <text>The following human body fluids:</text> <paragraph num="(i)"> <text>Amniotic fluid;</text> </paragraph> <paragraph num="(ii)"> <text>A body fluid that is visibly contaminated with blood;</text> </paragraph> <paragraph num="(iii)"> <text>A body fluid that cannot be readily identified;</text> </paragraph> <paragraph num="(iv)"> <text>Cerebrospinal fluid;</text> </paragraph> <paragraph num="(v)"> <text>Pericardial fluid;</text> </paragraph> <paragraph num="(vi)"> <text>Peritoneal fluid;</text> </paragraph> <paragraph num="(vii)"> <text>Pleural fluid;</text> </paragraph> <paragraph num="(viii)"> <text>Saliva only when dental procedures are performed;</text> </paragraph> <paragraph num="(ix)"> <text>Semen;</text> </paragraph> <paragraph num="(x)"> <text>Synovial fluid; and</text> </paragraph> <paragraph num="(xi)"> <text>Vaginal secretions;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A tissue or organ from a living or dead human, not including intact skin, that has not been preserved by a chemical additive or preservative;</text> </paragraph> <paragraph num="(c)"> <text>The following human immunodeficiency virus, hepatitis B virus, or hepatitis C virus related items:</text> <paragraph num="(i)"> <text>HIV containing cell, tissue, or organ cultures;</text> </paragraph> <paragraph num="(ii)"> <text>HIV, Hepatitis B, or Hepatitis C containing media or other solutions; and</text> </paragraph> <paragraph num="(iii)"> <text>Blood, organs, or other tissues; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Microbiological laboratory waste.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(20)"> <text>“Sanitary sewer” means:</text> <paragraph num="(a)"> <text>A liquid waste piping network leading to a sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>An on-site sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Sharps” means an object contaminated by blood or other potentially infectious material that can cut or penetrate the skin, including but not limited to:</text> <paragraph num="(a)"> <text>A broken capillary tube;</text> </paragraph> <paragraph num="(b)"> <text>Broken glass;</text> </paragraph> <paragraph num="(c)"> <text>An exposed end of dental wire;</text> </paragraph> <paragraph num="(d)"> <text>A needle;</text> </paragraph> <paragraph num="(e)"> <text>A surgical instrument; and</text> </paragraph> <paragraph num="(f)"> <text>A syringe with an attached sharp.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Special medical waste” means:</text> <paragraph num="(a)"> <text>Liquid or semiliquid blood or another potentially infectious material;</text> </paragraph> <paragraph num="(b)"> <text>A contaminated article that releases liquid or semiliquid blood or another potentially infectious material if compressed;</text> </paragraph> <paragraph num="(c)"> <text>An article that contains dried blood or another potentially infectious material and is capable of releasing the blood or material during handling;</text> </paragraph> <paragraph num="(d)"> <text>Pathological and microbiological waste containing blood or another potentially infectious material;</text> </paragraph> <paragraph num="(e)"> <text>Contaminated sharps; and</text> </paragraph> <paragraph num="(f)"> <text>Anatomical material.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Handling of Special Medical Waste."> <text>A person shall handle special medical waste in accordance with the requirements of:</text> <paragraph num="A."> <text>29 CFR §1910.1030(d)(4)(iii)(A) and (B), which is incorporated by reference at COMAR 09.12.31; and</text> </paragraph> <paragraph num="B."> <text>COMAR 26.13.12.05 and 26.13.13.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Treatment of Special Medical Waste, Excluding Sharps, Before Disposal."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a person shall:</text> <paragraph num="(1)"> <text>Treat special medical waste, excluding sharps, before disposal; and</text> </paragraph> <paragraph num="(2)"> <text>Use one of the following treatment methods:</text> <paragraph num="(a)"> <text>Autoclaving;</text> </paragraph> <paragraph num="(b)"> <text>Chemical disinfection;</text> </paragraph> <paragraph num="(c)"> <text>Cremation;</text> </paragraph> <paragraph num="(d)"> <text>Disinfection;</text> </paragraph> <paragraph num="(e)"> <text>Mechanical destruction after decontamination;</text> </paragraph> <paragraph num="(f)"> <text>Incineration; or</text> </paragraph> <paragraph num="(g)"> <text>An alternative method that meets the criteria of Regulation .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A person may discharge certain special medical waste directly into a sewerage system, without treatment, in accordance with Regulation.07B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Treatment of Sharps Before Disposal."> <text>A person shall treat sharps:</text> <paragraph num="A."> <text>Before disposal; and</text> </paragraph> <paragraph num="B."> <text>By one of the following methods:</text> <paragraph num="(1)"> <text>Encapsulation;</text> </paragraph> <paragraph num="(2)"> <text>Incineration;</text> </paragraph> <paragraph num="(3)"> <text>Mechanical destruction after decontamination; or</text> </paragraph> <paragraph num="(4)"> <text>An alternative method that meets the criteria of Regulation .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Alternative Treatment Systems."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a person may not use a method for treatment of special medical waste other than those set forth at Regulations .04A(2) and .05B of this chapter.</text> </paragraph> <paragraph num="B."> <text>Criteria for Alternative Treatment System. A person may use a method for treatment of special medical waste that complies with the following standards for treatment and microbial test procedures:</text> <paragraph num="(1)"> <text>The method inactivates vegetative bacteria, fungi, parasites, lipophilic or hydrophilic viruses, and mycobacteria at a 6 log reduction or greater;</text> </paragraph> <paragraph num="(2)"> <text>The method inactivates bacterial spores at a 4 log reduction or greater; and</text> </paragraph> <paragraph num="(3)"> <text>The tests have been performed on a representative from each of the following microbial groups:</text> <paragraph num="(a)"> <text>Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15422);</text> </paragraph> <paragraph num="(b)"> <text>Candida albicans (ATCC 18804) or Penicillium chrysogenum (ATCC 24791);</text> </paragraph> <paragraph num="(c)"> <text>Polio 2 or Polio 3 or MS-2 Bacteriophage, (ATCC 15597-B1);</text> </paragraph> <paragraph num="(d)"> <text>Cryptosporidium spp. oocysts or Giardia spp. cysts;</text> </paragraph> <paragraph num="(e)"> <text>Mycobacterium terrae, Mycobacterium phlei, or Mycobacterium bovis (BCG) (ATCC 35743); and</text> </paragraph> <paragraph num="(f)"> <text>Bacillus stearothermophilus (ATCC 7953) or Bacillus subtilis (ATCC 19659).</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A person may not use a method for treating of special medical waste that:</text> <paragraph num="(1)"> <text>Creates a threat to health or safety; or</text> </paragraph> <paragraph num="(2)"> <text>Violates applicable federal and State environmental laws or regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disposal of Special Medical Waste."> <paragraph num="A."> <text>Subject to §§B and C of this regulation, a person shall dispose of special medical waste after treatment by one of the following methods:</text> <paragraph num="(1)"> <text>Interment;</text> </paragraph> <paragraph num="(2)"> <text>Depositing in a facility approved to accept the type of solid waste being disposed in accordance with §C of this regulation; or</text> </paragraph> <paragraph num="(3)"> <text>Incineration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person may discharge a special medical waste that is liquid, semiliquid, or anatomical material that has been mechanically destroyed into a sewerage system, if the discharge is allowed under:</text> <paragraph num="(1)"> <text>Local ordinance or regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Environment Article, Title 9, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person shall dispose of special medical waste in accordance with:</text> <paragraph num="(1)"> <text>State laws and regulations pertaining to solid waste disposal including Environment Article, Title 9, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Local ordinances and regulations to the extent that the local requirements are not preempted by or in conflict with State law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Enforcement."> <paragraph num="A."> <text>The Secretary may enter the property of any person who generates, handles, treats, or disposes of special medical waste to investigate a complaint the Secretary receives regarding the handling, treatment, or disposal of special medical waste.</text> </paragraph> <paragraph num="B."> <text>Criminal Penalties.</text> <paragraph num="(1)"> <text>A person who violates these regulations is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $500.</text> </paragraph> <paragraph num="(2)"> <text>Each day that a violation exists shall constitute a separate offense.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to any penalty under §B, if a person violates these regulations, the Secretary may suspend or revoke any license, permit, or certificate issued to the person under the Health-General Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-102, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective September 30, 1988 (15:22 Md. R. 2547); emergency status expired March 29, 1989; adopted permanently effective May 1, 1989 (16:8 Md. R. 909)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 20, 1993 (20:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 20, 1993 (20:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective December 20, 1993 (20:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective December 20, 1993 (20:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 repealed and new Regulations .01—.07 adopted effective September 1, 2004 (31:16 Md. R. 1254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> </annotations> </chapter> <chapter num="07" heading="Sexually Transmitted Infections — Expedited Partner Therapy for Chlamydia, Gonorrhea, and Trichomoniasis"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>The purpose of expedited partner therapy in Maryland is to:</text> <paragraph num="(1)"> <text>Provide antibiotic therapy to any partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis without a personal physical assessment of the partner, and without having a previous provider-patient relationship with the partner;</text> </paragraph> <paragraph num="(2)"> <text>Contain and stop the further spread of chlamydia, gonorrhea, and trichomoniasis; and</text> </paragraph> <paragraph num="(3)"> <text>Reduce the likelihood of reinfection in the diagnosed patient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter applies to the provision of expedited partner therapy, as described in §A of this regulation, in public and private health care settings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Antibiotic therapy” means the oral antibiotic treatment regimens:</text> <paragraph num="(a)"> <text>Currently recommended by the Centers for Disease Control and Prevention for the treatment of chlamydia and gonorrhea through expedited partner therapy; and</text> </paragraph> <paragraph num="(b)"> <text>For the treatment of trichomoniasis through expedited partner therapy:</text> <paragraph num="(i)"> <text>In accordance with Regulation .05A of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>As authorized by Health-General Article, §18-214.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Expedited partner therapy (EPT)” means the prescribing or dispensing of antibiotic therapy to any partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis by certain health care providers without making a personal physical assessment of the partner, and without having a previous provider-patient relationship with the partner, in order to contain and stop the further spread of the infection and reduce the likelihood of reinfection in the diagnosed patient.</text> </paragraph> <paragraph num="(4)"> <text>“Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City, or the duly designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(5)"> <text>“Partner” means an individual with whom one has, or has had, oral, anal or vaginal sexual contact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Partners Eligible for EPT."> <text>Partners eligible for EPT are:</text> <paragraph num="A."> <text>Any partner within 60 calendar days of the patient’s diagnosis; or</text> </paragraph> <paragraph num="B."> <text>The most recent partner of a patient if the patient has not had sex in the 60 days before diagnosis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Health Care Providers Authorized to Prescribe and Dispense EPT."> <text>Notwithstanding any other provision of law, and only in accordance with their current scope of practice, EPT may be prescribed or dispensed by the following health care providers:</text> <paragraph num="A."> <text>A physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>An authorized physician assistant licensed under Health Occupations Article, Title 15, Annotated Code of Maryland, acting in accordance with Health Occupations Article, §15-302.2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>An advanced practice registered nurse with prescriptive authority licensed under Health Occupations Article, Title 8, Annotated Code of Maryland, acting in accordance with Health Occupations Article, §8–508, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="D."> <text>A registered nurse employed by a local health department who complies with:</text> <paragraph num="(1)"> <text>The formulary developed and approved under Health-General Article, §3-403(b), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The requirements established under Health Occupations Article, §8-512, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Pharmacists Authorized to Dispense EPT."> <text>Notwithstanding any other provision of law, a pharmacist licensed under Health Occupations Article, Title 12, Annotated Code of Maryland, may dispense antibiotic therapy for EPT prescribed in accordance with Regulation .04 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Prescribing and Dispensing EPT Medications."> <paragraph num="A."> <text>Antibiotic therapy prescribed or dispensed for EPT shall be in accordance with treatment recommendations from the Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="B."> <text>Prescribing.</text> <paragraph num="(1)"> <text>A separate prescription shall be issued for each partner.</text> </paragraph> <paragraph num="(2)"> <text>The designation “EPT” or “Expedited Partner Therapy” shall be included on the face of the prescription for each prescription issued.</text> </paragraph> <paragraph num="(3)"> <text>If the partner’s name is known, the prescription shall be issued in the partner’s name.</text> </paragraph> <paragraph num="(4)"> <text>If the partner’s name is unknown, the written designation “EPT” or “expedited partner therapy” shall be sufficient for the pharmacist to fill the prescription.</text> </paragraph> <paragraph num="(5)"> <text>An EPT prescription may not be refilled.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Dispensing. Each EPT medication label shall:</text> <paragraph num="(1)"> <text>Include:</text> <paragraph num="(a)"> <text>The designation “EPT” or “Expedited Partner Therapy”; and</text> </paragraph> <paragraph num="(b)"> <text>The partner’s name, if known; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comply with Health Occupations Article, §12-505, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Counseling and Educational Information Requirements."> <paragraph num="A."> <text>A health care provider prescribing or dispensing EPT to a patient shall:</text> <paragraph num="(1)"> <text>Counsel the patient to encourage each partner to seek a personal physical assessment; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the patient with educational information for each partner, in accordance with §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacist dispensing EPT shall provide educational information for each partner, in accordance with §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>The educational information, that is available or comparable to that available on the Department’s website, shall include:</text> <paragraph num="(1)"> <text>Advice for the partner to seek a medical evaluation;</text> </paragraph> <paragraph num="(2)"> <text>Information about chlamydia, gonorrhea, and trichomoniasis;</text> </paragraph> <paragraph num="(3)"> <text>Medication instructions;</text> </paragraph> <paragraph num="(4)"> <text>Warnings about adverse drug or allergic reactions; and</text> </paragraph> <paragraph num="(5)"> <text>Advice to abstain from sexual activity as required during treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Documenting EPT in a Medical Chart."> <paragraph num="A."> <text>A health care provider prescribing or dispensing EPT shall document the provision of EPT in the patient’s chart.</text> </paragraph> <paragraph num="B."> <text>Documentation shall include the:</text> <paragraph num="(1)"> <text>Number of EPT prescriptions or medications provided to the patient for each partner; and</text> </paragraph> <paragraph num="(2)"> <text>Medication and dosage being provided to the patient for each partner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reporting of Chlamydia and Gonorrhea by a Health Care Provider or Institution."> <paragraph num="A."> <text>This chapter may not affect the obligation of a health care provider or institution to report to a health officer cases of chlamydia and gonorrhea and the treatment provided to those cases in accordance with COMAR 10.06.01.04.</text> </paragraph> <paragraph num="B."> <text>When reporting a case of chlamydia or gonorrhea for which EPT was prescribed or dispensed, a health care provider or institution shall report the number of partners for whom:</text> <paragraph num="(1)"> <text>Prescriptions were provided; and</text> </paragraph> <paragraph num="(2)"> <text>Medications were dispensed.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 18-102, 18-201, 18-202, and 18-214.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 28, 2016 (43:6 Md. R. 406)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective March 26, 2018 (45:6 Md. R. 318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted effective March 26, 2018 (45:6 Md. R. 318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective March 26, 2018 (45:6 Md. R. 318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 26, 2018 (45:6 Md. R. 318)</annotation> </annotations> </chapter> </subtitle> <subtitle num="07" heading="Hospitals"> <chapter num="01" heading="Acute General Hospitals and Special Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited hospital” means a hospital accredited by The Joint Commission or other accreditation organization approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>“Accredited special rehabilitation hospital” means a hospital that is accredited by the Commission on Accreditation of Rehabilitation Facilities for providing comprehensive physical rehabilitation services.</text> </paragraph> <paragraph num="(2-1)"> <text>“Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative day” means a day of care rendered to a patient who no longer requires the level of care the hospital is licensed to provide.</text> </paragraph> <paragraph num="(4)"> <text>“Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medical services.</text> </paragraph> <paragraph num="(4-1)"> <text>Aftercare.</text> <paragraph num="(a)"> <text>“Aftercare” means any assistance provided by a lay caregiver to a patient after discharge of the patient.</text> </paragraph> <paragraph num="(b)"> <text>“Aftercare” includes tasks that are limited to the patient’s condition at the time of discharge that do not require a licensed professional.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Agent” means the individual or individuals, or organization that shall conduct utilization review activities in fulfillment of a hospital's responsibilities under these regulations. The agent may be a hospital employee or employees, or it may be an independent group or organization.</text> </paragraph> <paragraph num="(6)"> <text>“Appointment” means designation of a physician to have staff privileges at the hospital.</text> </paragraph> <paragraph num="(7)"> <text>“Authorized decision maker” means the health care agent, guardian of the person, or surrogate decision maker who is making health care decisions on behalf of a patient in accordance with the Health Care Decisions Act, Health-General Article, §§5-601—5-618, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Calculated licensed bed capacity” means the total number of inpatient beds recalculated annually as 140 percent of a general hospital's average daily census as determined by the Health Services Cost Review Commission for the most recent 12-month period.</text> </paragraph> <paragraph num="(9)"> <text>“Claim” means a written demand for damages as a result of alleged professional malpractice.</text> </paragraph> <paragraph num="(10)"> <text>“Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services and accredits those who provide the services.</text> </paragraph> <paragraph num="(11)"> <text>“Comprehensive physical rehabilitation services” has the same meaning as defined in Health-General Article, §19-1201(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Credentialing process” means the process by which a hospital:</text> <paragraph num="(a)"> <text>Verifies qualifications of a physician;</text> </paragraph> <paragraph num="(b)"> <text>Delineates clinical privileges of a physician; and</text> </paragraph> <paragraph num="(c)"> <text>Monitors performance of a physician.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(14)"> <text>“Elective”, when applied to admission or to a health care service, means an admission or service that can be delayed without substantial risk to the health of the individual.</text> </paragraph> <paragraph num="(15)"> <text>“Healthcare-associated infection” means an infection that:</text> <paragraph num="(a)"> <text>Develops in a patient who is cared for in any setting where healthcare is delivered; and</text> </paragraph> <paragraph num="(b)"> <text>Was not incubating or present at the time the healthcare was provided.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Hospital” means an institution that:</text> <paragraph num="(a)"> <text>Has a group of at least five physicians who are organized as a medical staff for the institution;</text> </paragraph> <paragraph num="(b)"> <text>Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Admits or retains the individuals for overnight care.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Incident” means any circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to a patient.</text> </paragraph> <paragraph num="(18)"> <text>“The Joint Commission” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18-1)"> <text>“Lay caregiver” means an individual who:</text> <paragraph num="(a)"> <text>Is an adult;</text> </paragraph> <paragraph num="(b)"> <text>Is designated as a lay caregiver by a patient or the legal guardian of a patient; and</text> </paragraph> <paragraph num="(c)"> <text>Performs aftercare for the patient at the residence of the patient.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“License” means a license issued by the Secretary to operate a hospital in this State.</text> </paragraph> <paragraph num="(20)"> <text>“Long-term care” means, for the purpose of this chapter, care provided in a hospital, but is designed to treat conditions requiring treatment at a level below that of acute hospital care.</text> </paragraph> <paragraph num="(21)"> <text>“Maryland Medical Assistance Program” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. For the purpose of this chapter, this shall include those persons provided care under the program administered and financed by the State for eligible needy persons who do not meet the technical requirements of federally funded Medical Assistance.</text> </paragraph> <paragraph num="(22)"> <text>“Medical Orders for Life Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Medicare Program” means the federal program of health insurance for the aged and disabled established pursuant to 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(24)"> <text>“Nonaccredited hospital” means a:</text> <paragraph num="(a)"> <text>Hospital not accredited by The Joint Commission or other accreditation organization approved by the Department; or</text> </paragraph> <paragraph num="(b)"> <text>Special rehabilitation hospital not accredited by The Joint Commission.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Nonelective”, when applied to admission or to a health care service, means an admission or service that cannot be delayed without substantial risk to the health of the individual.</text> </paragraph> <paragraph num="(26)"> <text>“Palliative care” means specialized medical care for individuals with serious illnesses or conditions that:</text> <paragraph num="(a)"> <text>Is focused on providing patients with relief from the symptoms, pain, and stress of a serious illness or condition, whatever the diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Has the goal of improving quality of life for the patient, the patient’s family, and other caregivers;</text> </paragraph> <paragraph num="(c)"> <text>Is provided at any age and at any stage in a serious illness or condition; and</text> </paragraph> <paragraph num="(d)"> <text>Can be provided along with curative treatment.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Palliative care program” means an interdisciplinary team that provides palliative care services.</text> </paragraph> <paragraph num="(28)"> <text>“Physician” has the meaning stated under Health Occupations Article, §14-101(j), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Plan” means a thorough written specification of how the elements of review required by these regulations shall be performed.</text> </paragraph> <paragraph num="(30)"> <text>“Privilege” means the authority granted to a physician by a hospital to:</text> <paragraph num="(a)"> <text>Admit patients to the hospital; or</text> </paragraph> <paragraph num="(b)"> <text>Perform specific procedures or treatments on patients at the hospital.</text> </paragraph> </paragraph> <paragraph num="(30-1)"> <text>Residence.</text> <paragraph num="(a)"> <text>“Residence” means a dwelling that a patient considers to be home.</text> </paragraph> <paragraph num="(b)"> <text>“Residence” does not include:</text> <paragraph num="(i)"> <text>A rehabilitation facility;</text> </paragraph> <paragraph num="(ii)"> <text>A hospital;</text> </paragraph> <paragraph num="(iii)"> <text>A nursing home;</text> </paragraph> <paragraph num="(iv)"> <text>An assisted living; or</text> </paragraph> <paragraph num="(v)"> <text>A group home licensed by the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(32)"> <text>“Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>Telemedicine.</text> <paragraph num="(a)"> <text>“Telemedicine” means the use of interactive audio, video, or other telecommunications or electronic technology by a physician in the practice of medicine outside the physical presence of the patient.</text> </paragraph> <paragraph num="(b)"> <text>“Telemedicine” does not include:</text> <paragraph num="(i)"> <text>An audio only telephone conversation between the physician and patient;</text> </paragraph> <paragraph num="(ii)"> <text>An electronic mail message between a physician and a patient; or</text> </paragraph> <paragraph num="(iii)"> <text>A facsimile transmission between a physician and a patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Unexpected adverse outcomes” means unanticipated negative outcomes related to a patient’s medical treatment and not related to the natural course of the patient’s illness or underlying disease condition.</text> </paragraph> <paragraph num="(35)"> <text>“Uniform standard credentialing form” means:</text> <paragraph num="(a)"> <text>The form designated by the Department through COMAR 10.07.01.24C(6) for credentialing physicians who seek to be employed by or have staff privileges at a hospital; or</text> </paragraph> <paragraph num="(b)"> <text>The uniform credentialing form that the Insurance Commissioner designates under Insurance Article, §15–112.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Utilization review” means a system for reviewing the appropriate and efficient allocation of hospital resources and services given or proposed to be given to a patient or group of patients.</text> </paragraph> <paragraph num="(37)"> <text>“Utilization review plan” means a description of the standards governing utilization review activities performed by a private review agent or hospital utilization review agent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>The following documents are incorporated by reference:</text> <paragraph num="A."> <text>Guidelines for Design and Construction of Hospitals, The Facilities Guidelines Institute (2022 Edition); and</text> </paragraph> <paragraph num="B."> <text>2025 Hospital Accreditation Standards, Elements of Performance, The Joint Commission, (December 15, 2024).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Hospital Classification."> <paragraph num="A."> <text>General Hospital. A hospital shall be classified as a general hospital if the hospital at least has the facilities and provides the services that are necessary for the general medical and surgical care of patients.</text> </paragraph> <paragraph num="B."> <text>Special Hospital. A hospital shall be classified as a special hospital if the hospital:</text> <paragraph num="(1)"> <text>Defines a program of specialized services, such as obstetrics, mental health, tuberculosis, orthopedy, chronic disease, or communicable disease;</text> </paragraph> <paragraph num="(2)"> <text>Admits only patients with medical or surgical needs within the program; and</text> </paragraph> <paragraph num="(3)"> <text>Has the facilities for and provides those specialized services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Special Rehabilitation Hospital. A hospital shall be classified as a special rehabilitation hospital if the hospital provides or holds itself out as providing comprehensive physical rehabilitation services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure Application Procedure."> <paragraph num="A."> <text>A person desiring to open a hospital, to continue the operation of an existing hospital, or to change the classification of an existing hospital shall file an application with the Secretary, on a written or electronic form provided by the Secretary. An application shall state the classification of hospital for which a license is sought.</text> </paragraph> <paragraph num="B."> <text>Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed.</text> </paragraph> <paragraph num="C."> <text>License Renewal. An application for the renewal of the license on a written or electronic form provided by the Secretary shall be made:</text> <paragraph num="(1)"> <text>By a nonaccredited hospital at least 60 days before expiration of the issued license; or</text> </paragraph> <paragraph num="(2)"> <text>By an accredited hospital within 30 calendar days of the exit date of the triennial survey conducted by an accreditation organization approved by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>License Fees.</text> <paragraph num="(1)"> <text>All applications shall be accompanied by the fee established by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>Accredited hospitals shall submit a $3,000 nonrefundable license fee per accreditation period, payable to the Department.</text> </paragraph> <paragraph num="(3)"> <text>Nonaccredited hospitals shall submit a $1,000 nonrefundable annual license fee, payable to the Department.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In order to ensure that the hospital's licensure information is current, the hospital shall immediately notify the Department in writing of any change in the hospital's:</text> <paragraph num="(1)"> <text>Name;</text> </paragraph> <paragraph num="(2)"> <text>Administrator; or</text> </paragraph> <paragraph num="(3)"> <text>Contact information such as mailing address and telephone number.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In order to ensure the completion of any review or inspection by the Department of any major renovations, construction of patient care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, and not previously provided by the hospital, the hospital shall notify the Department 60 days before its occupancy or operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Duration of License."> <paragraph num="A."> <text>The Secretary shall issue a license to an accredited hospital or special rehabilitation hospital for the term of the facility's accreditation.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall issue a license to a nonaccredited hospital for a term not to exceed 1 year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Separate License Required."> <paragraph num="A."> <text>Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management.</text> </paragraph> <paragraph num="B."> <text>Separate licenses are not required for separate buildings on the same grounds.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="Licensed Bed Capacity."> <paragraph num="A."> <text>On or before July 1, 2000, and each July 1 thereafter, the Secretary shall determine the authorized licensed bed capacity for each hospital classified as a general hospital.</text> </paragraph> <paragraph num="B."> <text>Methodology for Calculating Total Authorized Licensed Bed Capacity.</text> <paragraph num="(1)"> <text>The average daily census for each general hospital shall be obtained from the most current Health Services Cost Review Commission inpatient utilization data for a 12-month period.</text> </paragraph> <paragraph num="(2)"> <text>The calculation of average daily census shall include the utilization of inpatient medical-surgical, gynecology, obstetric, pediatric, and acute psychiatric service beds. Newborn services are excluded from the calculation of average daily census.</text> </paragraph> <paragraph num="(3)"> <text>The total licensed bed capacity for each general hospital shall equal 140 percent of the calculated average daily census for all inpatient acute care hospital services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application for Designation of Licensed Bed Capacity by Service.</text> <paragraph num="(1)"> <text>The Secretary shall annually forward to each general hospital its calculated total licensed bed capacity for the next licensure period and the current allocation of beds by major service category.</text> </paragraph> <paragraph num="(2)"> <text>In a format specified by the Secretary, each general hospital shall notify the Department of its designation of total beds by major service category for the next licensure period.</text> </paragraph> <paragraph num="(3)"> <text>The Maryland Health Care Commission shall review and approve the designation of total beds by major service category.</text> </paragraph> <paragraph num="(4)"> <text>This section does not permit a general hospital to reallocate bed capacity in a manner inconsistent with applicable statute and regulations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>On or before July 1, 2000, and each July 1 thereafter, the Secretary shall delicense any licensed hospital beds determined to be excess bed capacity under Regulation .07B of this chapter.</text> </paragraph> <paragraph num="E."> <text>Temporary Adjustments to Calculated Licensed Bed Capacity.</text> <paragraph num="(1)"> <text>If necessary to adequately meet demand for services, a general hospital may exceed its calculated licensed bed capacity if:</text> <paragraph num="(a)"> <text>On average for the 12-month period, the hospital does not exceed its licensed bed capacity based on the annual calculation; and</text> </paragraph> <paragraph num="(b)"> <text>The hospital includes in its monthly report to the Health Services Cost Review Commission the following information:</text> <paragraph num="(i)"> <text>The number of days in the month the hospital exceeded its licensed bed capacity, and</text> </paragraph> <paragraph num="(ii)"> <text>The number of beds that were in excess on each of those days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A hospital exceeding its calculated licensed bed capacity shall notify the Department within 5 business days of the effective dates of the change in a format specified by the Secretary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspections."> <paragraph num="A."> <text>New Hospitals. A hospital that began initial operation on or after July 1, 1982, shall be inspected for compliance with the safety and sanitation components of the regulations promulgated by the Department until the hospital receives accreditation by an accreditation organization approved by the Department. If the hospital has not applied for accreditation by an accreditation organization approved by the Department within 1 year after beginning operation or has had its application for accreditation rejected, the Department shall inspect the hospital for compliance with the standards adopted under this subtitle.</text> </paragraph> <paragraph num="B."> <text>Accredited Hospitals and Accredited Special Rehabilitation Hospitals. An accredited hospital and an accredited special rehabilitation hospital shall be subject to inspection under this chapter by the Department to:</text> <paragraph num="(1)"> <text>Determine compliance with a quality requirement;</text> </paragraph> <paragraph num="(2)"> <text>Follow up on any serious problem identified by an accreditation organization approved by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Investigate a complaint; or</text> </paragraph> <paragraph num="(4)"> <text>Validate the findings of an accreditation organization approved by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nonaccredited Hospitals. Nonaccredited hospitals shall be subject to at least two inspections per year by the Department.</text> </paragraph> <paragraph num="D."> <text>Inspection by Secretary. The Secretary may inspect any:</text> <paragraph num="(1)"> <text>Hospital record or record of any utilization review agent of a hospital pertaining to review activities under the utilization review plan of the hospital to enforce the provisions of Regulations .13—.22 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Physician credentialing record to enforce the provisions of Regulation .24 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Hospital patient safety record, patient complaint record, or hospital patient record pertaining to review activities under a hospital's patient safety program to enforce the provisions of COMAR 10.07.06.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Complaint Investigations."> <paragraph num="A."> <text>Notwithstanding any other provisions of this subtitle, each hospital and residential treatment center shall be open to inspections by the Department to investigate and resolve any complaint concerning patient care, safety, medical and nursing supervision, physical environment, sanitation, or dietary matters.</text> </paragraph> <paragraph num="B."> <text>Complaints.</text> <paragraph num="(1)"> <text>To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency, the Department shall refer the complaint directly to the hospital.</text> </paragraph> <paragraph num="(2)"> <text>If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the hospital and may be referred to the appropriate licensure Board for resolution.</text> </paragraph> <paragraph num="(3)"> <text>If the Department determines that the hospital has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a life-threatening deficiency, the Department shall conduct an independent investigation. When conducting its independent investigation, the Department shall use the standards adopted by the Secretary under this subtitle and:</text> <paragraph num="(a)"> <text>For an accredited hospital, the hospital accreditation standards of the accreditation organization that accredits the hospital;</text> </paragraph> <paragraph num="(b)"> <text>For an accredited special rehabilitation hospital, the service standards adopted by the Secretary in Regulation .10 of this chapter; or</text> </paragraph> <paragraph num="(c)"> <text>For a nonaccredited hospital, the standards adopted by the Secretary in Regulation .09 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Service Standards — Nonaccredited Hospitals."> <paragraph num="A."> <text>Acute General Hospitals and Special Hospitals. Nonaccredited acute general and special hospitals shall comply with The Joint Commission’s Hospital Accreditation Standards.</text> </paragraph> <paragraph num="B."> <text>Waiver Authority. The Secretary may, for good cause, waive compliance with the incorporated Joint Commission standards. The hospital shall justify the need for the waiver in the manner prescribed by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Service Standards — Special Rehabilitation Hospitals."> <paragraph num="A."> <text>Before a special rehabilitation hospital can provide or hold itself out as providing comprehensive physical rehabilitation services, the special rehabilitation hospital shall:</text> <paragraph num="(1)"> <text>Except as otherwise provided in this regulation, be accredited by the Commission on Accreditation of Rehabilitation Facilities; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the standards of the Commission on Accreditation of Rehabilitation Facilities as set forth in the Medical Rehabilitation Standards Manual, which is incorporated by reference under COMAR 10.07.18.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Accreditation.</text> <paragraph num="(1)"> <text>To allow a special rehabilitation hospital to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any special rehabilitation hospital that has submitted an appropriate application for accreditation.</text> </paragraph> <paragraph num="(2)"> <text>The waiver under this section shall be effective for not more than 2 years from the later of:</text> <paragraph num="(a)"> <text>July 1, 1986; or</text> </paragraph> <paragraph num="(b)"> <text>The date on which the facility begins operations.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Special Rehabilitation Programs — Hospitals."> <paragraph num="A."> <text>Except as otherwise provided in this regulation, before a hospital can provide or hold itself out as providing any specialized rehabilitation program, the hospital shall be accredited by the Commission on Accreditation of Rehabilitation Facilities to provide the program.</text> </paragraph> <paragraph num="B."> <text>The requirement that a hospital be accredited by the Commission on Accreditation of Rehabilitation Facilities before the hospital can provide any specialized rehabilitation program shall be waived if the hospital has applied for accreditation for the program, for not more than 2 years from the later of:</text> <paragraph num="(1)"> <text>July 1, 1986; or</text> </paragraph> <paragraph num="(2)"> <text>The date on which the hospital begins operation of the specialized rehabilitation program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Records and Reports — Inspection."> <text>Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe by regulation, and all these records shall be open to inspection by the Secretary.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Utilization Review Plan."> <paragraph num="A."> <text>Before October 1, 1985, each hospital shall submit a proposed utilization review plan to the Secretary.</text> </paragraph> <paragraph num="B."> <text>Effective October 1, 1985, each hospital shall have in effect a utilization review plan approved by the Secretary pursuant to this chapter.</text> </paragraph> <paragraph num="C."> <text>The purpose of the hospital's utilization review program, as defined by the plan, shall be to determine for patients included in the hospital's review responsibilities the:</text> <paragraph num="(1)"> <text>Reasonableness and medical necessity of care given or proposed to be given at the hospital;</text> </paragraph> <paragraph num="(2)"> <text>Quality of care given at the hospital; and</text> </paragraph> <paragraph num="(3)"> <text>Appropriateness of the level of care proposed or given, including whether the care could be or could have been provided appropriately and more economically on an outpatient basis or in a facility that provides a lower level of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A utilization review plan shall:</text> <paragraph num="(1)"> <text>Identify the designated utilization review agent;</text> </paragraph> <paragraph num="(2)"> <text>Describe the criteria to be used in evaluating proposed or delivered hospital care;</text> </paragraph> <paragraph num="(3)"> <text>Delineate the types and kinds of cases that the agent will review and the circumstances under which either some or all patients in the hospital, or within specific diagnostic groups, will be selected;</text> </paragraph> <paragraph num="(4)"> <text>Make provisions for the collecting, storing, and reporting of data;</text> </paragraph> <paragraph num="(5)"> <text>Define measures by which the agent can evaluate the effectiveness of its program;</text> </paragraph> <paragraph num="(6)"> <text>Make provisions for screening medical records pertaining to patients for which the agent has review responsibility in order to identify and verify problems in the quality of care;</text> </paragraph> <paragraph num="(7)"> <text>Establish a mechanism through which patients, physicians, or third-party payers may seek reconsideration of decisions made by the utilization review agent;</text> </paragraph> <paragraph num="(8)"> <text>Detail how each of the following elements is to be performed by the agent:</text> <paragraph num="(a)"> <text>Pre-admission review of elective admissions;</text> </paragraph> <paragraph num="(b)"> <text>Post-admission review of nonelective admissions;</text> </paragraph> <paragraph num="(c)"> <text>Concurrent or retrospective review of admissions;</text> </paragraph> <paragraph num="(d)"> <text>Pre-authorization of certain selected procedures proposed to be performed on an inpatient basis;</text> </paragraph> <paragraph num="(e)"> <text>Institution of an objective second surgical opinion protocol to evaluate the desirability of performing selected surgical procedures on an elective basis;</text> </paragraph> <paragraph num="(f)"> <text>Discharge planning review;</text> </paragraph> <paragraph num="(g)"> <text>Continued stay review; and</text> </paragraph> <paragraph num="(h)"> <text>Re-admission review;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Meet all other requirements for utilization review promulgated by the Secretary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Utilization Review Agent."> <paragraph num="A."> <text>Each hospital shall appoint a utilization review agent to carry out the requirements of the utilization review plan. When the agent is composed of hospital related personnel the hospital's plan shall expressly designate the positions and the organizational structure within the hospital that constitute the utilization review agent for that institution.</text> </paragraph> <paragraph num="B."> <text>Each utilization review plan shall set forth the manner in which the agent:</text> <paragraph num="(1)"> <text>Utilizes the services of doctors of medicine or osteopathy and other practitioners capable of admitting patients, who are representative of practicing physicians in the area in which the hospital is located.</text> </paragraph> <paragraph num="(2)"> <text>Has available the services of sufficient numbers of physicians and dentists to assure the adequate review of medical specialty and subspecialty cases.</text> </paragraph> <paragraph num="(3)"> <text>Utilizes the services of registered nurses, medical records technicians, or similarly qualified persons supported and supervised by physicians in carrying out its review activities.</text> </paragraph> <paragraph num="(4)"> <text>Uses only a doctor of medicine, osteopathy, or dentistry to make a final determination that care rendered or to be rendered was, is, or may be medically inappropriate.</text> </paragraph> <paragraph num="(5)"> <text>Makes direct comparisons with professionally developed, objective criteria to determine the appropriateness of admission and continued stay. The criteria should:</text> <paragraph num="(a)"> <text>Be nationally recognized and accepted, unless a special exception is granted by the Secretary;</text> </paragraph> <paragraph num="(b)"> <text>Be capable of being utilized to define the type and extent of services which are to be considered as within the range of appropriate diagnosis and treatment for a given condition;</text> </paragraph> <paragraph num="(c)"> <text>Identify the level of care at which the services can appropriately and economically be rendered; and</text> </paragraph> <paragraph num="(d)"> <text>Recognize that for many conditions more than one mode or site of treatment or diagnosis may be medically acceptable.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Collects information relevant to its function, maintains records, and reports to the Department as required. The hospital's utilization review plan shall outline the method by which patient confidentiality shall be maintained.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A member of the agent's staff, or any person that the agent may delegate or employ, may not review or make a determination of appropriateness for care that that person was directly responsible for providing, or which was provided by or to a member of that person's family.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Performance Standards for Utilization Review."> <text>The hospital's program shall apply to all patients with the exceptions of those noted in Regulation .17, below. Except when noted for certain types of review, the program may delineate certain types and kinds of cases to be reviewed, so as to most efficiently carry out the purposes of these regulations. As a minimum, the hospital utilization review program shall satisfy the following performance standards:</text> <paragraph num="A."> <text>Pre-admission Review.</text> <paragraph num="(1)"> <text>A review of those elective admissions identified under the plan shall be performed by the agent in advance of the proposed admission.</text> </paragraph> <paragraph num="(2)"> <text>The purpose of this review shall be to determine the reasonableness and medical necessity of the admission, and the appropriateness of the level of proposed care.</text> </paragraph> <paragraph num="(3)"> <text>In conducting the review, the agent may supplement the information provided by the hospital through discussion with the patient's physician.</text> </paragraph> <paragraph num="(4)"> <text>The agent, using specific medical criteria, shall render a decision as to whether the admission is medically appropriate within 3 working days of the time it receives the case, except in those circumstances when responding within this period would not permit sufficient consultation or discussion to render a responsible opinion.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Post-admission Review.</text> <paragraph num="(1)"> <text>For those categories of emergency admissions identified for review in the hospital's plan, the agent shall carry out a review to ascertain the:</text> <paragraph num="(a)"> <text>Reasonableness and medical necessity of the admission;</text> </paragraph> <paragraph num="(b)"> <text>Appropriateness of the level of care provided; and</text> </paragraph> <paragraph num="(c)"> <text>Justification for the non-elective nature of the admission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agent shall be notified by the hospital within 24 working hours of the admission and the agent shall carry out the review within 3 working days of notification, except in cases when appropriate consultation cannot be carried out in this period of time.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Concurrent or Retrospective Review.</text> <paragraph num="(1)"> <text>For patients included in the plan the agent shall determine whether each day of the patient's hospitalization was medically necessary and appropriate based upon nationally recognized criteria. The agent shall also designate those days of hospitalization caused by administrative requirements including days on which patients await appropriate placement or equipment needed after discharge.</text> </paragraph> <paragraph num="(2)"> <text>The review may be concurrent with the patient's stay or take place after the patient is discharged.</text> </paragraph> <paragraph num="(3)"> <text>Days designated as administrative shall be found appropriate only if approved under discharge planning review, as discussed in §F.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Pre-authorization Review.</text> <paragraph num="(1)"> <text>The agent shall review prospectively all elective admissions in which one or more of the plan designated procedures is the principal procedure being performed for that admission.</text> </paragraph> <paragraph num="(2)"> <text>The procedures for which pre-authorization is required are set forth in Regulation .21.</text> </paragraph> <paragraph num="(3)"> <text>The agent may approve inpatient treatment for the listed procedures only if there is documentation that equivalent outpatient treatment would not be medically appropriate for the patient.</text> </paragraph> <paragraph num="(4)"> <text>All non-elective admissions that have not been pre-authorized and that subsequently involve performance of one or more of the plan designated procedures shall be reviewed concurrently or retrospectively by the agent.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Objective Second Opinion.</text> <paragraph num="(1)"> <text>Before an elective admission for a surgical procedure designated below, the patient shall obtain an objective second opinion.</text> </paragraph> <paragraph num="(2)"> <text>The procedures for which a second opinion is required are set forth in Regulation .22.</text> </paragraph> <paragraph num="(3)"> <text>The second opinion may be rendered by any physician of the patient's choosing except a physician having any financial relationship with the patient's original physician.</text> </paragraph> <paragraph num="(4)"> <text>Should a voluntary admission not take place within 6 months of the rendering of the second opinion, then another opinion shall be sought before admission.</text> </paragraph> <paragraph num="(5)"> <text>The agent may waive the requirement for obtaining a second opinion because:</text> <paragraph num="(a)"> <text>Obtaining the second opinion would impose a hardship on the patient; or</text> </paragraph> <paragraph num="(b)"> <text>The patient's medical insurance does not cover second opinions, and was:</text> <paragraph num="(i)"> <text>Issued and delivered in another state, and</text> </paragraph> <paragraph num="(ii)"> <text>Not intended to cover persons living or working in Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Discharge Planning.</text> <paragraph num="(1)"> <text>The utilization review plan shall set forth the hospital's discharge planning procedures.</text> </paragraph> <paragraph num="(2)"> <text>The agent shall review the effectiveness of the hospital's discharge planning.</text> </paragraph> <paragraph num="(3)"> <text>The agent shall review those days of care which have been designated to be administrative as a result of the agent's concurrent or retrospective review.</text> </paragraph> <paragraph num="(4)"> <text>Administrative days may be approved as necessary and appropriate only if evidence can be found that the hospital has developed and implemented a discharge plan at the earliest possible time and there is evidence that appropriate placement efforts have been made.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Continued Stay Review. For patients in beds licensed for long term care, the agent shall periodically review and certify as appropriate the level of care and placement, and the medical necessity of treatment prescribed.</text> </paragraph> <paragraph num="H."> <text>Re-admission Review. The agent shall review the appropriateness of the previous discharge and the indications for admission for hospitalizations occurring shortly after a previous discharge.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Protection of Patients — Patient Liability."> <paragraph num="A."> <text>Charges for any days disallowed as a result of retrospective review by the agent or by a payer conducting utilization review under these regulations shall be deducted from the gross charges in the bill to the patient as a contractual allowance unless the patient refuses or has refused to leave the hospital when it is medically appropriate to do so, and the disallowed days occur:</text> <paragraph num="(1)"> <text>After the hospital has notified the patient in writing of the potential disallowance; or</text> </paragraph> <paragraph num="(2)"> <text>As a direct result of the noncompliance by the patient to treatment or hospital regulations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a bill is generated before the receipt of the results of retrospective review, a subsequent adjustment to the bill, if required under Sec. A, above, shall be issued by the hospital. The final bill shall demonstrate all procedures, services, or days of care found to be inappropriate.</text> </paragraph> <paragraph num="C."> <text>In cases when a form of review other than retrospective review was performed, each patient bill generated by the hospital shall clearly demonstrate all procedures, services, or days of care which have been found to be inappropriate or have been disallowed by the hospital's utilization review agent or any other reviewer or payer conducting utilization review.</text> </paragraph> <paragraph num="D."> <text>The utilization review agent shall be responsible for establishing a process by which physicians and patients may request clarification and reconsideration of review decisions. These clarifications or reconsiderations shall be carried out in a timely fashion, and patients shall be granted full access to any medical records maintained by the agent pertaining to their care to the extent permitted under Health-General Article, § 4-302, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Exemptions from Hospital Utilization Review."> <paragraph num="A."> <text>A hospital shall be exempt from carrying out utilization review procedures for a given patient if the:</text> <paragraph num="(1)"> <text>Person, corporate entity, or insurance plan paying for the patient's hospitalization has a utilization review program that is determined by the Insurance Commissioner and the Secretary to substantially meet the minimum standards described in these regulations, including the reporting requirements detailed in Regulation .19 of this chapter, those programs and amendments to them having been submitted to the Commissioner for approval;</text> </paragraph> <paragraph num="(2)"> <text>Patient is a subscriber or a member of a health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>Patient is a Medicare or Maryland Medical Assistance Program beneficiary, and the services rendered at the hospital are within the scope of coverage provided by the relevant program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary will issue yearly lists of third-party payers known to have utilization review plans that qualify for the exemption described in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Record Maintenance by Utilization Review Agents."> <paragraph num="A."> <text>The plan shall describe how, in addition to maintaining documents which describe its utilization review procedures, the agent shall maintain the following records for each individual patient for whom any aspect of the utilization review procedure has been applied:</text> <paragraph num="(1)"> <text>The patient's name, hospital history number, source of payment, and other demographic information capable of identifying the patient.</text> </paragraph> <paragraph num="(2)"> <text>The principal diagnosis or diagnoses (with corresponding codes listed in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) as defined in COMAR 10.09.06.01P), and the particular category of patient chosen for review in accordance with the hospital's utilization review plan.</text> </paragraph> <paragraph num="(3)"> <text>The date or dates on which review activities were requested and the date or dates on which opinions were rendered.</text> </paragraph> <paragraph num="(4)"> <text>The type of review carried out, the nature of the criteria applied, and the results of the review. In the case of disallowed services, the reasons for disallowance shall be stated, as well as the name of the physician member of the agent's staff making the final disallowance determination.</text> </paragraph> <paragraph num="(5)"> <text>In the case of objective second opinions, documentation shall include the name of the physician rendering the second opinion, the physician's specialty, and the nature of the opinion.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each agent shall maintain a listing of all reviewed cases suitable for the selection of a sample of all cases reviewed within each 2-year certification period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Reports to the Secretary."> <paragraph num="A."> <text>Each hospital shall report annually to the Secretary the following summary statistics on the activity of its utilization review program:</text> <paragraph num="(1)"> <text>The number of discharges and total patient days reviewed under the program;</text> </paragraph> <paragraph num="(2)"> <text>For each of the procedures requiring pre-authorization for inpatient treatment, the number of patients:</text> <paragraph num="(a)"> <text>Reviewed; and</text> </paragraph> <paragraph num="(b)"> <text>Approved for inpatient treatment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For each of the procedures requiring an objective second opinion, the number of patients:</text> <paragraph num="(a)"> <text>Undergoing the procedure at the hospital;</text> </paragraph> <paragraph num="(b)"> <text>Admitted non-electively for the procedure;</text> </paragraph> <paragraph num="(c)"> <text>Admitted electively after the patient had obtained a second opinion; and</text> </paragraph> <paragraph num="(d)"> <text>Admitted electively but for whom the requirement of a second opinion was waived, including a tabulation of the reasons for waivers;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For admissions reviewed concurrently or retrospectively, the number of all reviewed admissions disapproved, and reasons for disapproval;</text> </paragraph> <paragraph num="(5)"> <text>The number of all reviewed days of hospitalization disapproved, by reason for disapproval;</text> </paragraph> <paragraph num="(6)"> <text>A summary of the findings of re-admission review, including the frequency and proportion of these cases, the diagnoses or treatments involved, and the reasons found;</text> </paragraph> <paragraph num="(7)"> <text>A listing and description of quality care problems found by the agent in the course of reviewing patient records in furtherance of its duties under the utilization review plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary shall be allowed access to hospital patient records and to the records of the hospital's utilization review agent pertaining to review activities under the plan for the purpose of enforcing these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Penalties."> <text>If a hospital fails to submit a utilization review plan or fails, after adequate discussion with the Department, to develop an approvable plan, or fails to operate a plan which has been approved, then the Secretary may impose upon the hospital the following penalties:</text> <paragraph num="A."> <text>Delicensure of the hospital; or</text> </paragraph> <paragraph num="B."> <text>A fine of $500 for each day that the hospital is in violation of these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Procedures for Which Preauthorization is Required — Repealed." /> <regulation prefix="Regulation" num=".22" heading="Practitioner Performance Evaluation."> <paragraph num="A."> <text>Consistent with the standards of the Joint Commission for focused and ongoing professional performance evaluations, the hospital shall establish a practitioner performance evaluation process that objectively evaluates the performance of each member of the medical staff.</text> </paragraph> <paragraph num="B."> <text>The hospital’s practitioner performance evaluation process shall include a review of care which shall:</text> <paragraph num="(1)"> <text>Be undertaken for cases:</text> <paragraph num="(a)"> <text>Chosen at random; and</text> </paragraph> <paragraph num="(b)"> <text>With unexpected adverse outcomes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be based on objective review standards;</text> </paragraph> <paragraph num="(3)"> <text>Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and</text> </paragraph> <paragraph num="(4)"> <text>Be conducted by members of the medical staff, or at the discretion of the hospital, by external reviewers, who:</text> <paragraph num="(a)"> <text>Are of the same specialty as the member of the medical staff under review;</text> </paragraph> <paragraph num="(b)"> <text>Have been trained to perform practitioner performance evaluation; and</text> </paragraph> <paragraph num="(c)"> <text>Are not otherwise associated with the case under review.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A hospital shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Guidelines Governing the Transfer of Patients Between Hospitals."> <paragraph num="A."> <text>If a hospital is able to provide adequate care to a patient, the hospital may not transfer the patient to another hospital unless:</text> <paragraph num="(1)"> <text>One or more of the following circumstances is present:</text> <paragraph num="(a)"> <text>The patient does not have a physician with privileges at the hospital and the patient refuses treatment by any physician with privileges at the hospital;</text> </paragraph> <paragraph num="(b)"> <text>The patient or a legally authorized representative of the patient requests the transfer;</text> </paragraph> <paragraph num="(c)"> <text>The transfer is in compliance with relevant sections of Health-General Article, Title 10, Subtitle 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>The transfer is in compliance with the Interstate Compact on Mental Health as adopted in Health-General Article, Title 11, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(e)"> <text>The transfer is in compliance with any agreement entered into between the Department and a hospital for the provision of acute inpatient psychiatric care in State hospital conversion beds;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>These circumstances are documented in the patient's medical record; and</text> </paragraph> <paragraph num="(3)"> <text>The provisions of this regulation are met.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A hospital may not use the inability of a patient to pay or the source of payment for a patient as a reason to transfer the patient to another hospital.</text> </paragraph> <paragraph num="C."> <text>Before moving a patient, the transferring hospital shall:</text> <paragraph num="(1)"> <text>Determine that the patient can be transferred without causing harm to the patient;</text> </paragraph> <paragraph num="(2)"> <text>Notify the receiving hospital of the transfer; and</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise provided for in an agreement with the Department for State hospital conversion beds, obtain from the receiving hospital confirmation that:</text> <paragraph num="(a)"> <text>The receiving hospital consents to accept the patient; and</text> </paragraph> <paragraph num="(b)"> <text>The patient meets any criteria that the receiving hospital has established for admission regarding:</text> <paragraph num="(i)"> <text>The patient's required level of care;</text> </paragraph> <paragraph num="(ii)"> <text>Physician services available; and</text> </paragraph> <paragraph num="(iii)"> <text>Other services necessary to treat the patient.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Explanation of Transfer.</text> <paragraph num="(1)"> <text>Except as otherwise provided in §C(2),, of this regulation, before moving a patient, the transferring hospital shall provide explanation of the reasons for the transfer and any alternative to the transfer to the patient or to a legally authorized representative of the patient.</text> </paragraph> <paragraph num="(2)"> <text>If the transferring hospital can document that the necessity to move the patient to the receiving hospital is immediate to protect the health, safety, or welfare of the patient, the transferring hospital may give the explanation required in §C(1), of this regulation, concurrently with the transfer.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In effecting a transfer, the transferring hospital shall provide that:</text> <paragraph num="(1)"> <text>Medically appropriate life-support measures that a reasonable and prudent physician exercising ordinary care would use are used to stabilize the patient before transfer and sustain the patient during transfer;</text> </paragraph> <paragraph num="(2)"> <text>Appropriate personnel and equipment that a reasonable and prudent physician exercising ordinary care would use are provided and used in the transfer; and</text> </paragraph> <paragraph num="(3)"> <text>All records necessary for continuing the patient's care are transferred with the patient.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall inspect hospitals for compliance with this regulation as provided in Regulations .07 and .08 of this chapter.</text> </paragraph> <paragraph num="G."> <text>Penalties.</text> <paragraph num="(1)"> <text>The Secretary may impose a penalty not exceeding $1,000 per violation on any hospital that violates this regulation.</text> </paragraph> <paragraph num="(2)"> <text>In determining the amount of the penalty, the Secretary shall consider:</text> <paragraph num="(a)"> <text>The hospital's history of previous violations;</text> </paragraph> <paragraph num="(b)"> <text>The seriousness of the violation;</text> </paragraph> <paragraph num="(c)"> <text>Whether the hospital demonstrated good faith in attempting to comply with this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>Whether the violation threatened the health or safety of:</text> <paragraph num="(i)"> <text>A patient; or</text> </paragraph> <paragraph num="(ii)"> <text>The public.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Physician Credentialing Process."> <paragraph num="A."> <text>General. In accordance with this regulation, a hospital shall have in effect a credentialing process.</text> </paragraph> <paragraph num="B."> <text>Scope of Credentialing Process. The credentialing process shall apply to any physician who shall admit or treat patients in the hospital.</text> </paragraph> <paragraph num="C."> <text>Specific Standard — Appointment and Employment Process.</text> <paragraph num="(1)"> <text>In accordance with this section, a hospital shall establish a formal written process for the appointment or employment of a physician by the hospital.</text> </paragraph> <paragraph num="(2)"> <text>The term of an appointment may not exceed the term established by the standards of the accreditation organization that accredits the hospital.</text> </paragraph> <paragraph num="(3)"> <text>The formal written appointment or employment process shall provide for a probationary period that shall be successfully completed before the finalization of the appointment or employment of the physician.</text> </paragraph> <paragraph num="(4)"> <text>As part of the formal written appointment and employment process, the hospital shall collect, verify, review, and document the following information about the physician:</text> <paragraph num="(a)"> <text>The physician's education;</text> </paragraph> <paragraph num="(b)"> <text>The clinical expertise of the physician;</text> </paragraph> <paragraph num="(c)"> <text>The professional experience of the physician including:</text> <paragraph num="(i)"> <text>Any board certification or specialty training of the physician;</text> </paragraph> <paragraph num="(ii)"> <text>The internship of the physician; and</text> </paragraph> <paragraph num="(iii)"> <text>The residencies of the physician;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Any license or registration to practice a health occupation ever held by the physician, including:</text> <paragraph num="(i)"> <text>A license to practice medicine; and</text> </paragraph> <paragraph num="(ii)"> <text>DEA registration;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Whether any license or registration to practice a health occupation ever held by the physician has been:</text> <paragraph num="(i)"> <text>Suspended;</text> </paragraph> <paragraph num="(ii)"> <text>Revoked;</text> </paragraph> <paragraph num="(iii)"> <text>Voluntarily surrendered or not renewed;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Concerning any hospital where the physician was appointed or employed:</text> <paragraph num="(i)"> <text>The name of the hospital;</text> </paragraph> <paragraph num="(ii)"> <text>The term of appointment or employment;</text> </paragraph> <paragraph num="(iii)"> <text>Privileges held and any disciplinary action taken on the privileges, including suspension, revocation, limitation, or voluntary surrender;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Concerning the physician's professional liability insurance:</text> <paragraph num="(i)"> <text>The physician's present carrier;</text> </paragraph> <paragraph num="(ii)"> <text>The physician's current limits of coverage;</text> </paragraph> <paragraph num="(iii)"> <text>The physician's current types of coverage;</text> </paragraph> <paragraph num="(iv)"> <text>Restrictions on the physician's coverage; and</text> </paragraph> <paragraph num="(v)"> <text>Whether or not the physician has maintained continuous malpractice coverage since first obtaining professional insurance;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Any claim that has been made against the physician in the practice of any health occupation and the status of the claim;</text> </paragraph> <paragraph num="(i)"> <text>The physician's medical history including the physician's current mental and physical health status;</text> </paragraph> <paragraph num="(j)"> <text>A complaint or report filed with:</text> <paragraph num="(i)"> <text>The Board of Physicians or any other state medical discipline agency;</text> </paragraph> <paragraph num="(ii)"> <text>A state medical society;</text> </paragraph> <paragraph num="(iii)"> <text>A state disciplinary body; or</text> </paragraph> <paragraph num="(iv)"> <text>A professional or specialty association.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>The formal written process shall provide for the documentation of any action taken by the hospital regarding the appointment or employment of the physician.</text> </paragraph> <paragraph num="(6)"> <text>Uniform Standard Credentialing Form.</text> <paragraph num="(a)"> <text>A hospital shall use the uniform standard credentialing form approved by the Department for the initial credentialing of a physician seeking appointment or employment.</text> </paragraph> <paragraph num="(b)"> <text>Use of the uniform standard credentialing form does not preclude a hospital from requiring additional information, attestations, or supplemental documentation as required by that hospital's credentialing process.</text> </paragraph> <paragraph num="(c)"> <text>A physician seeking hospital privileges shall submit an updated and complete uniform standard credentialing form at the time of application to each hospital.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Specific Standard — Granting of Delineated Clinical Privileges.</text> <paragraph num="(1)"> <text>In accordance with this section, a hospital shall establish a formal written process for the granting of delineated clinical privileges.</text> </paragraph> <paragraph num="(2)"> <text>The formal written process shall include:</text> <paragraph num="(a)"> <text>Criteria for determining whether a physician shall be granted privileges by the hospital to provide specific services;</text> </paragraph> <paragraph num="(b)"> <text>Criteria for ongoing evaluation of the performance of the services for which privileges have been granted;</text> </paragraph> <paragraph num="(c)"> <text>Procedures for altering, suspending, or revoking the delineated privileges.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The formal written process shall provide for documentation of any actions taken regarding delineated privileges.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Specific Standard — Reappointment.</text> <paragraph num="(1)"> <text>In accordance with this section, a hospital shall establish a formal written process for the reappointment of a physician who has been appointed to the hospital.</text> </paragraph> <paragraph num="(2)"> <text>The term of reappointment shall be 2 years or less.</text> </paragraph> <paragraph num="(3)"> <text>As part of the formal written appointment process, a hospital shall collect, verify, review, and document the following information about the physician:</text> <paragraph num="(a)"> <text>An update of the information regarding appointment under §C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Concerning the physician's pattern of performance based on an analysis of the following:</text> <paragraph num="(i)"> <text>Claims filed against the physician;</text> </paragraph> <paragraph num="(ii)"> <text>Utilization, quality and risk data;</text> </paragraph> <paragraph num="(iii)"> <text>A review of clinical skills;</text> </paragraph> <paragraph num="(iv)"> <text>Adherence to hospital bylaws, policies, and procedures;</text> </paragraph> <paragraph num="(v)"> <text>Compliance with continuing medical education requirements;</text> </paragraph> <paragraph num="(vi)"> <text>An assessment of current mental and physical health status;</text> </paragraph> <paragraph num="(vii)"> <text>Attitudes, cooperation, and the ability to work with others; and</text> </paragraph> <paragraph num="(viii)"> <text>The results of the Practitioner Performance Evaluation process as described in Health-General Article, §§19-3B-01—19-3B-09, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Specific Standard — Record Maintenance.</text> <paragraph num="(1)"> <text>In accordance with this section, a hospital shall maintain a separate credentialing file for each physician.</text> </paragraph> <paragraph num="(2)"> <text>The credentialing file for each physician shall contain documentation relating to the credentialing process required under this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Disaster Privileges.</text> <paragraph num="(1)"> <text>During an emergency or disaster in which the hospital's disaster or emergency management plan has been activated, when the Governor has declared that a state of emergency exists, or when the Secretary has issued an order pursuant to Health-General Article, §18-905, Annotated Code of Maryland, the chief executive officer, medical staff president, or designee may grant temporary disaster privileges to licensed physicians who have not been appointed to the hospital's medical staff.</text> </paragraph> <paragraph num="(2)"> <text>The hospital shall develop a medical staff plan for the granting of disaster privileges that identifies:</text> <paragraph num="(a)"> <text>The individual responsible for granting disaster privileges;</text> </paragraph> <paragraph num="(b)"> <text>The responsibilities of that individual;</text> </paragraph> <paragraph num="(c)"> <text>A system to manage, assign, and supervise the physicians who have been granted disaster privileges; and</text> </paragraph> <paragraph num="(d)"> <text>The process by which credentials and privileges are verified as soon as the situation allows, ensuring that the process complies with §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physicians granted disaster privileges by a hospital shall:</text> <paragraph num="(a)"> <text>Be registered and trained by the Department as part of the Department's Maryland Physician Volunteer Corps and possess the Department issued photo identification; or</text> </paragraph> <paragraph num="(b)"> <text>Comply with the hospital's medical staff plan for granting privileges in a disaster, which shall require at least one of the following:</text> <paragraph num="(i)"> <text>Presentation of a current Maryland license to practice medicine and a valid identification picture (ID) issued by a state, federal, or regulatory agency;</text> </paragraph> <paragraph num="(ii)"> <text>Presentation of a license to practice medicine from another state if a state of emergency has been declared by the Governor and the assistance of the physician has been requested by Maryland pursuant to the Emergency Management Assistance Compact, Public Safety Article, §14-702, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Presentation of a current photo identification card from another Maryland hospital where the physician is a member of the medical staff; or</text> </paragraph> <paragraph num="(iv)"> <text>Verification by a current member of the hospital's medical staff who has personal knowledge regarding the practitioner's identity and current Maryland medical licensure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Disaster privileges shall be discontinued when the hospital's chief executive officer, medical staff president, or designee determines that the emergency condition no longer exists and that the hospital has adequate resources to meet the patient's needs.</text> </paragraph> <paragraph num="(5)"> <text>The hospital shall maintain records that include:</text> <paragraph num="(a)"> <text>The number of hours worked by each physician;</text> </paragraph> <paragraph num="(b)"> <text>The type of service provided by each physician;</text> </paragraph> <paragraph num="(c)"> <text>The location where these services were provided; and</text> </paragraph> <paragraph num="(d)"> <text>Any additional information required by the Department for federal and State reimbursement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Telemedicine. Notwithstanding any other provision of COMAR 10.07.01.24, in its credentialing and privileging process for a physician who provides medical services to the patients at the hospital only through telemedicine from a distant-site hospital or distant-site telemedicine entity, a hospital may rely on the credentialing and privileging decisions made for the physician by the distant-site hospital or distant-site telemedicine entity as authorized under 42 C.F.R. Part 482, if:</text> <paragraph num="(1)"> <text>The physician who provides medical services through telemedicine holds a license to practice medicine in the State under Health Occupations Article, Title 14, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The credentialing and privileging decisions with respect to the physician who provides medical services through telemedicine are:</text> <paragraph num="(a)"> <text>Approved by the medical staff of the hospital; and</text> </paragraph> <paragraph num="(b)"> <text>Recommended by the medical staff of the hospital to the hospital’s governing body.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Request for Documentation by Department. On request from the Department, a hospital shall provide documentation that before:</text> <paragraph num="(1)"> <text>Appointment or employment of a physician or granting delineated privileges, the hospital has complied with the requirements of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Reappointment or renewing of employment or specific privileges, the hospital has complied with the requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Penalties. If a hospital fails to have in effect a credentialing process in accordance with these regulations, the Secretary may impose upon the hospital the following penalties:</text> <paragraph num="(1)"> <text>Delicensure of the hospital; or</text> </paragraph> <paragraph num="(2)"> <text>A fine of $500 for each day that the hospital is in violation of these regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Medical Professional Liability Closed Claim Form."> <paragraph num="A."> <text>A hospital shall complete and submit to the Department the approved Medical Professional Liability Closed Claim form, for each medical liability claim filed regarding the care or services received by a patient under the care of that hospital.</text> </paragraph> <paragraph num="B."> <text>Regardless of the result of a closed claim, the hospital shall submit the Medical Professional Liability Closed Claim form to the Department within 90 days after the end of the quarter during which the final judgment, settlement, or final disposition of the claim was made.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Anatomical Donations."> <paragraph num="A."> <text>This regulation does not:</text> <paragraph num="(1)"> <text>Limit the right of an individual to make a gift under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Interfere with the duties of the office of the Chief Medical Examiner.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A hospital shall develop and follow a protocol in accordance with this regulation for the procurement of organs and tissues.</text> </paragraph> <paragraph num="C."> <text>Requests for Donation on Death of Patient.</text> <paragraph num="(1)"> <text>In accordance with this regulation, whenever a patient of a hospital meets the following criteria, the administrator of the hospital shall designate a person to request that the representative of the patient consent to the donation of the organs and tissues of the patient:</text> <paragraph num="(a)"> <text>The patient may be pronounced dead in accordance with Health-General Article, §5-202, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The patient has not given actual notice of an objection to the donation of his or her organs and tissues; and</text> </paragraph> <paragraph num="(c)"> <text>The patient has not made a gift of all or part of his or her body under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A hospital may not make a request for consent to a donation if the use of all of the organs or tissues of the patient is medically contraindicated.</text> </paragraph> <paragraph num="(3)"> <text>In making a request required in §C(1), of this regulation, the hospital designee shall:</text> <paragraph num="(a)"> <text>Make a reasonable effort to locate and contact the appropriate person set forth in §D, of this regulation, as the representative of the deceased patient; and</text> </paragraph> <paragraph num="(b)"> <text>Request that the representative consent to a donation of any organ or tissue of the patient which is suitable for donation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Determination of Patient Representative for Consent to Donation.</text> <paragraph num="(1)"> <text>The representative of a deceased patient shall be:</text> <paragraph num="(a)"> <text>The spouse of the patient, but, if the spouse is not competent; then</text> </paragraph> <paragraph num="(b)"> <text>Any adult son or daughter of the patient, but, if no adult child of the patient is competent; then</text> </paragraph> <paragraph num="(c)"> <text>Either parent of the patient, but, if neither is competent; then</text> </paragraph> <paragraph num="(d)"> <text>Any adult brother or sister of the patient, but, if no adult sibling of the patient is competent; then</text> </paragraph> <paragraph num="(e)"> <text>Any guardian of the person of the patient, but, if the patient has no guardian of his or her person; then</text> </paragraph> <paragraph num="(f)"> <text>Any other person authorized or obligated by law to dispose of the body of the patient.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the death of a patient occurs suddenly and the patient was in apparent good health or unattended by a physician, the hospital shall notify and cooperate with the office of the Chief Medical Examiner before the removal of any organ or tissue.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Discretion and Sensitivity in Making Requests. In making a request for donation, the hospital designee shall show reasonable discretion and sensitivity to the:</text> <paragraph num="(1)"> <text>Circumstances of the family of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Religious beliefs of the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Suitability of the organs or tissues for donation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Documentation. The designee shall document in the medical record of the patient:</text> <paragraph num="(1)"> <text>Any request made for donation of organs or tissues;</text> </paragraph> <paragraph num="(2)"> <text>Any consent to donate organs or tissues;</text> </paragraph> <paragraph num="(3)"> <text>Whether a donation is made and accepted;</text> </paragraph> <paragraph num="(4)"> <text>Any objection to the donation made by:</text> <paragraph num="(a)"> <text>The patient, or</text> </paragraph> <paragraph num="(b)"> <text>An appropriate representative of a patient as set forth in §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The reason for electing not to make a request for organ or tissue donation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Discharge Planning Requirements."> <paragraph num="A."> <text>Discharge Options. A hospital may discharge a patient:</text> <paragraph num="(1)"> <text>Entirely;</text> </paragraph> <paragraph num="(2)"> <text>To another level of care, treatment, or services;</text> </paragraph> <paragraph num="(3)"> <text>To different health care professionals; or</text> </paragraph> <paragraph num="(4)"> <text>To settings for continued services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A hospital's process for transfer or discharge shall be based on a patient's assessed needs at the time of discharge.</text> </paragraph> <paragraph num="C."> <text>To facilitate discharge or transfer, the hospital shall:</text> <paragraph num="(1)"> <text>Assess the patient's needs beginning at an early stage of the patient's hospitalization and as the patient's needs change throughout the hospitalization;</text> </paragraph> <paragraph num="(2)"> <text>Develop plans for the patient's discharge or transfer with input, if appropriate, from the patient, the family, or other interested party;</text> </paragraph> <paragraph num="(3)"> <text>Identify appropriately qualified staff, such as registered nurses or licensed social workers, who have the knowledge and experience necessary to determine what services or type of providers can best meet the patient's discharge needs;</text> </paragraph> <paragraph num="(4)"> <text>Arrange or help to arrange for services needed to meet the patient's needs after discharge; and</text> </paragraph> <paragraph num="(5)"> <text>Provide the patient, or the provider who is responsible for providing continuing care to the patient, with written discharge instructions and other necessary medical information in a form the patient or provider can understand.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Emergency and Disaster Plan."> <paragraph num="A."> <text>A licensed acute general hospital or special hospital shall comply with the Emergency Management standards outlined in The Joint Commission’s Hospital Accreditation Standards.</text> </paragraph> <paragraph num="B."> <text>A licensee shall prepare an executive summary of the hospital's evacuation procedures to provide to a patient, family member, or legal representative upon request. The summary shall:</text> <paragraph num="(1)"> <text>Describe the hospital's Emergency Operation Plan (EOP), which is discussed throughout the Emergency Management standards cited in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Describe the role and responsibilities of a patient, family member, or legal representative in the event of an emergency situation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall have a tracking system to assist the hospital, family members, government representatives, and other authorized stakeholders, to locate and identify patients in the event of displacement due to an emergency or disaster.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Notice to Patients of Outpatient on Observation Status."> <paragraph num="A."> <text>A hospital shall provide both an oral and written notice to a patient of:</text> <paragraph num="(1)"> <text>The patient’s outpatient on observation status;</text> </paragraph> <paragraph num="(2)"> <text>The billing implications of the outpatient on observation status; and</text> </paragraph> <paragraph num="(3)"> <text>The impact of the outpatient on observation status on the patient’s eligibility for Medicare rehabilitation services if:</text> <paragraph num="(a)"> <text>The patient received on-site services from the hospital for more than 23 consecutive hours;</text> </paragraph> <paragraph num="(b)"> <text>The on-site services received by the patient include a hospital bed and meals that have been provided in an area of the hospital other than the Emergency Department; and</text> </paragraph> <paragraph num="(c)"> <text>The patient is classified as an outpatient at the hospital for observation rather than as an admitted inpatient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The written notice shall include:</text> <paragraph num="(1)"> <text>That the patient is considered to be on observation as an outpatient and is not admitted as an inpatient;</text> </paragraph> <paragraph num="(2)"> <text>The reason or rationale that the patient has not been admitted for inpatient services;</text> </paragraph> <paragraph num="(3)"> <text>That the patient, if needed upon discharge, may not qualify for Medicare Part A reimbursement for rehabilitation services, including such services provided under Medicare Part A in a skilled nursing facility;</text> </paragraph> <paragraph num="(4)"> <text>That there may be billing implications based on their outpatient status that may increase the patient’s out-of-pocket costs for their stay;</text> </paragraph> <paragraph num="(5)"> <text>The name and title of the staff who provided the oral notice stating the date and time of the oral notice; and</text> </paragraph> <paragraph num="(6)"> <text>The signature of the patient to verify an understanding and receipt of the written notice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Once the patient has received onsite services for more than 23 hours, the hospital shall provide written and oral notice to the patient that the physician has ordered services be provided as outpatient on observation status.</text> </paragraph> <paragraph num="D."> <text>The oral and written notice shall be provided in a manner that is understood by the patient.</text> </paragraph> <paragraph num="E."> <text>If the patient lacks capacity to understand the medical or financial implications of his or her outpatient on observation status, the oral and written notice shall be provided to a person authorized to make medical or financial decisions for the patient, including:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An agent appointed under an advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>An agent appointed under a power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>A representative payee or other similar fiduciary; or</text> </paragraph> <paragraph num="(7)"> <text>Any other person, if that person was designated by the patient who was competent at the time of designation, and the patient or representative has provided the hospital with documentation of the designation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>For Medicare patients only, a hospital has the option to provide only the notice required by Medicare under 42 CFR §489.20(y). Hospitals that elect to use that option shall be considered compliant with this regulation if the notice is provided to patients that receive on-site services for more than 23 hours.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Physical Environment."> <paragraph num="A."> <text>The facility shall be in compliance with:</text> <paragraph num="(1)"> <text>The Facilities Guidelines Institute's Guidelines for Design and Construction of Hospitals; and</text> </paragraph> <paragraph num="(2)"> <text>All applicable State and local governing laws, regulations, standards, ordinances, and codes for fire safety, building, and zoning requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Any waiver or other modification of these requirements shall be addressed by the appropriate State or local authority having jurisdiction in accordance with established procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Hospital Palliative Care Programs."> <paragraph num="A."> <text>Acute general hospitals and special hospitals-chronic care with 50 or more beds shall establish an active hospitalwide palliative care program that provides consultation services to patients suffering from pain and symptoms due to serious illnesses or conditions.</text> </paragraph> <paragraph num="B."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Promote the palliative care program;</text> </paragraph> <paragraph num="(2)"> <text>Provide information and referrals to patients and families when appropriate regarding the availability of palliative care services; and</text> </paragraph> <paragraph num="(3)"> <text>Inform patients of the patient’s right to request a palliative care consultation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>The hospital shall designate a qualified interdisciplinary care team with training in palliative care to staff the palliative care program.</text> </paragraph> <paragraph num="(2)"> <text>The hospital shall ensure that:</text> <paragraph num="(a)"> <text>A qualified health care professional coordinates the activities of the palliative care program with the palliative care patient’s interdisciplinary care team;</text> </paragraph> <paragraph num="(b)"> <text>Staff is appropriately trained, credentialed, or certified in the staff’s area of expertise;</text> </paragraph> <paragraph num="(c)"> <text>Staff receives continuing training and education; and</text> </paragraph> <paragraph num="(d)"> <text>Written policies and procedures for the hospital palliative care program are established, implemented, maintained, and updated periodically.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Palliative Care Education and Training. The hospital shall provide and document training to medical and other clinical staff as determined by the hospital regarding:</text> <paragraph num="(1)"> <text>Services provided by the palliative care program;</text> </paragraph> <paragraph num="(2)"> <text>Domains of palliative care; and</text> </paragraph> <paragraph num="(3)"> <text>Legal requirements for:</text> <paragraph num="(a)"> <text>Health care decisions; and</text> </paragraph> <paragraph num="(b)"> <text>MOLST as referenced in COMAR 10.01.21.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Interdisciplinary Plan of Care.</text> <paragraph num="(1)"> <text>The hospital shall incorporate the recommendations of the palliative care program into the palliative care patient’s interdisciplinary care plan.</text> </paragraph> <paragraph num="(2)"> <text>The hospital shall review the interdisciplinary plan of care and revise it as necessary to meet the needs of the palliative care patient.</text> </paragraph> <paragraph num="(3)"> <text>The palliative care program shall conduct care conferences as appropriate to review the plan of care with:</text> <paragraph num="(a)"> <text>The palliative care patient;</text> </paragraph> <paragraph num="(b)"> <text>The palliative care patient’s family;</text> </paragraph> <paragraph num="(c)"> <text>The health care professionals; and</text> </paragraph> <paragraph num="(d)"> <text>Other interdisciplinary team members.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Contents. The hospital shall ensure that the palliative care patient’s plan of care includes at a minimum:</text> <paragraph num="(a)"> <text>Initial assessments conducted by the interdisciplinary palliative care team;</text> </paragraph> <paragraph num="(b)"> <text>Psychological needs assessment;</text> </paragraph> <paragraph num="(c)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(d)"> <text>Choice of treatment options;</text> </paragraph> <paragraph num="(e)"> <text>Preferred care setting;</text> </paragraph> <paragraph num="(f)"> <text>Availability of hospice services;</text> </paragraph> <paragraph num="(g)"> <text>Preferred site of death and after-death arrangements, as appropriate;</text> </paragraph> <paragraph num="(h)"> <text>Grief and bereavement plan, as appropriate;</text> </paragraph> <paragraph num="(i)"> <text>Assessment of cultural needs;</text> </paragraph> <paragraph num="(j)"> <text>Assessment of legal needs; and</text> </paragraph> <paragraph num="(k)"> <text>Assessment of discharge needs.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Collaboration. The hospital shall document and provide palliative care services in collaboration with:</text> <paragraph num="(a)"> <text>The attending physician; and</text> </paragraph> <paragraph num="(b)"> <text>Any other health care provider managing the patient’s care.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Continuity of Care. The hospital shall coordinate services to ensure continuity of care for the palliative care patient. The hospital shall:</text> <paragraph num="(a)"> <text>Transfer the pertinent parts of the medical record, medical orders, and plan of care with the palliative care patient upon transfer to post-acute care;</text> </paragraph> <paragraph num="(b)"> <text>Ensure that MOLST forms are completed in accordance with COMAR 10.01.21;</text> </paragraph> <paragraph num="(c)"> <text>Convert a palliative care patient’s treatment goals into medical orders, as appropriate; and</text> </paragraph> <paragraph num="(d)"> <text>Have reporting mechanisms to keep all staff informed and updated about care changes and treatment goals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Palliative Care Services.</text> <paragraph num="(1)"> <text>The hospital or palliative care program shall counsel the palliative care patient or the patient’s authorized decision maker regarding:</text> <paragraph num="(a)"> <text>Health options;</text> </paragraph> <paragraph num="(b)"> <text>Pain management options;</text> </paragraph> <paragraph num="(c)"> <text>Prognosis;</text> </paragraph> <paragraph num="(d)"> <text>Risks and benefits of treatment;</text> </paragraph> <paragraph num="(e)"> <text>Availability of grief and bereavement services, as appropriate;</text> </paragraph> <paragraph num="(f)"> <text>Psychological services;</text> </paragraph> <paragraph num="(g)"> <text>Availability of spiritual care counseling through the hospital or outpatient providers; and</text> </paragraph> <paragraph num="(h)"> <text>Hospice services, as appropriate.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Referrals.</text> <paragraph num="(a)"> <text>As appropriate and upon request by the patient or authorized decision maker, the hospital may make timely referrals.</text> </paragraph> <paragraph num="(b)"> <text>The hospital shall document any referrals made to:</text> <paragraph num="(i)"> <text>Inpatient or outpatient bereavement providers;</text> </paragraph> <paragraph num="(ii)"> <text>Psychological services for the palliative care patient and the patient’s family;</text> </paragraph> <paragraph num="(iii)"> <text>Inpatient or outpatient spiritual care services; and</text> </paragraph> <paragraph num="(iv)"> <text>Hospice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pain and Symptom Management. The hospital shall:</text> <paragraph num="(a)"> <text>Conduct and document pain and symptom assessments using available standardized scales to appropriately manage a palliative care patient’s symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Provide adequate and appropriate dosage of analgesics and sedatives to meet the needs of the palliative care patient; and</text> </paragraph> <paragraph num="(c)"> <text>Educate the patient and the patient’s family about the use of opioids during end-of-life care.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Other Services. The hospital shall provide culturally and linguistically appropriate education and support about how to safely care for the patient at home or in an alternate residential setting as appropriate.</text> </paragraph> <paragraph num="(5)"> <text>Imminent Death. The palliative care program shall document and counsel the patient, the authorized decision maker, the patient’s family, and the interdisciplinary care team about the active dying phase and imminent death as appropriate.</text> </paragraph> <paragraph num="(6)"> <text>MOLST. The hospital shall comply with the procedures and requirements of the Medical Orders for Life-Sustaining Treatment Form, which is incorporated by reference at COMAR 10.07.21.</text> </paragraph> <paragraph num="(7)"> <text>Interpreter Services. The hospital shall ensure interpreter services are available and accessible to the palliative care program.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Advance Directives.</text> <paragraph num="(1)"> <text>The hospital shall recognize the authority of:</text> <paragraph num="(a)"> <text>An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>An authorized decision maker.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital shall ensure that any provided advance directive and authorized decision maker designation are in the patient’s medical record, including the electronic medical record.</text> </paragraph> <paragraph num="(3)"> <text>The hospital shall promote advance care planning and the completion of advance directives through community outreach activities.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Ethics Committee. The hospital shall allow staff, patients, and the patient’s family in the palliative care program access to an ethics committee to address ethical conflicts at the end of life.</text> </paragraph> <paragraph num="I."> <text>Quality Improvement. The palliative care program shall take part in the hospital’s quality improvement and performance improvement activities to the extent required by State and federal statute.</text> </paragraph> <paragraph num="J."> <text>Departmental Oversight. The Department shall have access to all data maintained through the hospital’s palliative care program to determine the hospital’s compliance with State and federal regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Penalties — General."> <paragraph num="A."> <text>The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="C."> <text>The Secretary may deny or revoke a license if the hospital does not meet the requirements of:</text> <paragraph num="(1)"> <text>Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A hospital subject to a fine or a penalty, or to delicensure, denial, or revocation of license under these regulations, may request a hearing as set forth under State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32-1" heading="Civil Money Penalties — Imposition."> <paragraph num="A."> <text>The Department may impose a civil money penalty not to exceed $10,000 for each failure of a hospital to comply with the requirements of Regulation .27 of this chapter.</text> </paragraph> <paragraph num="B."> <text>In determining whether to impose a civil money penalty, the Department may consider the following factors:</text> <paragraph num="(1)"> <text>The number of failures to comply;</text> </paragraph> <paragraph num="(2)"> <text>The nature and seriousness of the failure to comply;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the patient being discharged that is caused by the failure to comply;</text> </paragraph> <paragraph num="(4)"> <text>A hospital's prior history to comply with discharge requirements; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".32-2" heading="Civil Money Penalties — Payment of Penalty."> <paragraph num="A."> <text>If a hospital owes a civil money penalty to the Department, the hospital shall adhere to the procedures of this regulation.</text> </paragraph> <paragraph num="B."> <text>A civil money penalty payment is due to the Department 15 calendar days after:</text> <paragraph num="(1)"> <text>The time period for requesting a hearing has expired if a request for hearing is not received; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt of a written request from the hospital to waive its right to a hearing and reduce the amount of the civil penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".32-3" heading="Civil Money Penalties — Hearings."> <paragraph num="A."> <text>A hospital aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary has the burden of proof with respect to the imposition of civil money penalties.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Uniform Emergency Codes."> <paragraph num="A."> <text>Each hospital shall adopt and implement the following set of uniform codes for the identified emergency situations as part of its emergency or disaster plans:</text> <paragraph num="(1)"> <text>Fire — Code Red;</text> </paragraph> <paragraph num="(2)"> <text>Infant or Child Abduction — Code Pink;</text> </paragraph> <paragraph num="(3)"> <text>Cardiac Respiratory Arrest — Code Blue — Adult;</text> </paragraph> <paragraph num="(4)"> <text>Cardiac Respiratory Arrest — Code Blue — Child;</text> </paragraph> <paragraph num="(5)"> <text>Cardiac Respiratory Arrest — Code Blue — Infant;</text> </paragraph> <paragraph num="(6)"> <text>Combative Person — Code Green;</text> </paragraph> <paragraph num="(7)"> <text>Bomb Threat — Code Gold;</text> </paragraph> <paragraph num="(8)"> <text>Hazardous Material Spill or Release — Code Orange;</text> </paragraph> <paragraph num="(9)"> <text>Elopement — Code Gray;</text> </paragraph> <paragraph num="(10)"> <text>Security Only Response — Code Purple;</text> </paragraph> <paragraph num="(11)"> <text>Emergency or Disaster — Code Yellow; and</text> </paragraph> <paragraph num="(12)"> <text>Armed Assailant — Code Silver.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A hospital may adapt the uniform codes referenced in §A of this regulation to meet the specific needs of the hospital by adding a suffix or additional words after that code.</text> </paragraph> <paragraph num="C."> <text>For emergency situations not addressed by the codes in §A of this regulation, a hospital may establish its own identifying code.</text> </paragraph> <paragraph num="D."> <text>A hospital shall adopt only those uniform color codes that are consistent with the services or needs of the hospital.</text> </paragraph> <paragraph num="E."> <text>As part of its emergency or disaster plan, the hospital shall establish its own protocol for each of the uniform codes.</text> </paragraph> <paragraph num="F."> <text>A hospital shall provide orientation and training to all staff regarding the uniform emergency codes and the hospital's emergency or disaster plan.</text> </paragraph> <paragraph num="G."> <text>A hospital seeking exceptions to the requirements of this regulation shall submit its plan for emergency codes to the Department for review and approval:</text> <paragraph num="(1)"> <text>Within 90 days after the effective date of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Before implementation of changes in its emergency code that would not comply with §§A—F of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Infection Prevention and Control Program."> <paragraph num="A."> <text>The hospital shall have an active hospital-wide program for the prevention, control, and investigation of communicable diseases and infections.</text> </paragraph> <paragraph num="B."> <text>Staffing.</text> <paragraph num="(1)"> <text>The hospital shall designate qualified staff with training in infection prevention and control to be responsible for the implementation of the infection prevention and control program.</text> </paragraph> <paragraph num="(2)"> <text>Additional clinical and support staff shall be provided for the infection prevention and control program based on the size and complexity of the hospital's services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Prevention and Control Program.</text> <paragraph num="(1)"> <text>The infection prevention and control program shall be based on nationally recognized, evidence-based standards.</text> </paragraph> <paragraph num="(2)"> <text>The infection prevention and control program shall be developed using an interdisciplinary approach with input from:</text> <paragraph num="(a)"> <text>Administrative staff;</text> </paragraph> <paragraph num="(b)"> <text>Medical staff;</text> </paragraph> <paragraph num="(c)"> <text>Pharmacy staff;</text> </paragraph> <paragraph num="(d)"> <text>Laboratory personnel;</text> </paragraph> <paragraph num="(e)"> <text>Nursing staff;</text> </paragraph> <paragraph num="(f)"> <text>Physical plant personnel;</text> </paragraph> <paragraph num="(g)"> <text>Employee health personnel;</text> </paragraph> <paragraph num="(h)"> <text>Patient safety officer; and</text> </paragraph> <paragraph num="(i)"> <text>Staff from other departments whose knowledge and experience would contribute to improved infection prevention and control.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Written policies and procedures for the infection prevention and control program shall be established, implemented, maintained, and updated periodically.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Surveillance.</text> <paragraph num="(1)"> <text>The hospital shall:</text> <paragraph num="(a)"> <text>Have a process for the identification and surveillance of healthcare- associated infections;</text> </paragraph> <paragraph num="(b)"> <text>Analyze and utilize surveillance data to monitor and improve infection control and healthcare outcomes; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain a log of the identified infections.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The infection prevention and control program shall include:</text> <paragraph num="(a)"> <text>Processes for the monitoring and control of patients who have a communicable disease or infection to prevent its spread to other patients and staff;</text> </paragraph> <paragraph num="(b)"> <text>A process to identify and investigate the occurrence of outbreaks of communicable diseases or clusters of infections; and</text> </paragraph> <paragraph num="(c)"> <text>Reporting of infections, communicable diseases, and outbreaks to the local or State health department, as required by COMAR 10.06.01.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When an outbreak occurs, the infection control staff shall have adequate resources and authority to ensure comprehensive and timely investigation and to implement control measures.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Education.</text> <paragraph num="(1)"> <text>The hospital shall provide education to all staff and, if appropriate, to the patient and visitors regarding the prevention and control of communicable diseases and infections. Educational activities shall address problems identified by the infection prevention and control program.</text> </paragraph> <paragraph num="(2)"> <text>Nonclinical staff shall be included in infection prevention and control training consistent with their assigned responsibilities.</text> </paragraph> <paragraph num="(3)"> <text>Attendance or participation in an educational program shall be recorded. Educational programs shall be evaluated not less than annually for effectiveness.</text> </paragraph> <paragraph num="(4)"> <text>Education related to infection prevention and control shall be included in the hospital's orientation program for all new employees, including appropriate contractual personnel.</text> </paragraph> <paragraph num="(5)"> <text>Physicians who are employed or who have privileges and who do not receive training through the hospital's new employee training program shall receive alternative orientation education on infection prevention and control practices and the hospital's infection prevention and control program.</text> </paragraph> <paragraph num="(6)"> <text>Outside agency staff shall receive sufficient training in the hospital's infection prevention and control policies and procedures to provide safe care to the patients.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Prevention.</text> <paragraph num="(1)"> <text>The hospital shall establish processes and programs to prevent the spread of communicable diseases and infections.</text> </paragraph> <paragraph num="(2)"> <text>A hospital's processes and programs to prevent the spread of communicable diseases and infections shall include at least the items listed in §F(3) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Required Processes and Programs.</text> <paragraph num="(a)"> <text>Hand Hygiene.</text> <paragraph num="(i)"> <text>The infection prevention and control program shall include activities to educate staff on the need for hand hygiene prior to and after any patient contact and as directed by accepted professional practice.</text> </paragraph> <paragraph num="(ii)"> <text>Hand hygiene compliance by staff shall be monitored through the infection prevention and control program.</text> </paragraph> <paragraph num="(iii)"> <text>The infection prevention and control program shall maintain documentation of audits for compliance with this requirement.</text> </paragraph> <paragraph num="(iv)"> <text>Facilities and supplies to facilitate hand hygiene shall be provided and be accessible in all locations of the hospital where patient care is provided.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Sanitation.</text> <paragraph num="(i)"> <text>The hospital shall maintain a sanitary environment to prevent the spread of communicable diseases and infections.</text> </paragraph> <paragraph num="(ii)"> <text>The hospital shall have systems to maintain the environment in a clean and sanitary condition.</text> </paragraph> <paragraph num="(iii)"> <text>Systems shall be provided to ensure that housekeeping, linen handling, waste disposal including medical waste, food handling, ventilation systems, water systems, and pest control meet acceptable federal and State standards and guidelines.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Aseptic Technique. The hospital shall use aseptic techniques to prevent infections, including surgical site infections and device-associated infections.</text> </paragraph> <paragraph num="(d)"> <text>Immunocompromised Patients. The hospital shall use professionally accepted procedures to protect immunocompromised patients from infection.</text> </paragraph> <paragraph num="(e)"> <text>Standard Precautions. The hospital staff shall use standard precautions and other categories of isolation or precautions consistent with current Center for Disease Control (CDC) recommendations.</text> </paragraph> <paragraph num="(f)"> <text>Equipment and Supplies.</text> <paragraph num="(i)"> <text>The hospital shall have personal protective equipment, such as gloves, gowns, respirators, and masks or other facial protection for staff readily available.</text> </paragraph> <paragraph num="(ii)"> <text>Supplies and equipment needed to prevent the spread of communicable diseases and infections shall be available in all patient care areas.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Employee Health Program. The infection prevention and control program shall work in conjunction with the employee health program and include monitoring and identification of employee health concerns such as immunity to measles, mumps, rubella, and varicella (chicken pox).</text> </paragraph> <paragraph num="(5)"> <text>Immunizations for influenza shall be offered to staff and licensed independent practitioners. Reasons for refusal of the influenza vaccine by an employee shall be documented by the infection control or employee health program.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Performance Improvement.</text> <paragraph num="(1)"> <text>The infection prevention and control program shall include performance improvement and quality assurance measures to address the problems identified through the surveillance, control, and investigation of infections.</text> </paragraph> <paragraph num="(2)"> <text>The hospital shall develop and implement interventions to address identified problems and monitor the effectiveness of interventions to control and prevent infections.</text> </paragraph> <paragraph num="(3)"> <text>The infection prevention and control program shall be incorporated into the hospital's performance improvement program.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Patient Safety. The infection prevention and control program shall share data regarding healthcare-associated infections with the hospital's designated patient safety officer. Health care associated infections that meet the definition of a Level 1 adverse event shall be reported to the Department, and a root cause analysis submitted as required by COMAR 10.07.06.</text> </paragraph> <paragraph num="I."> <text>Reports to the Governing Body.</text> <paragraph num="(1)"> <text>Infection control data including reports on the numbers and types of healthcare-associated infections shall be reported to the hospital's medical staff and governing body on an ongoing basis.</text> </paragraph> <paragraph num="(2)"> <text>The hospital leadership shall support infection prevention and control activities, including the provision of adequate resources for the program.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Department Oversight.</text> <paragraph num="(1)"> <text>The hospital shall comply with all data reporting requirements of the Maryland Health Care Commission related to the prevention and acquisition of infections in accordance with Health-General Article, §19-134(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall have access to all data maintained through the hospital's infection prevention and control program to determine the hospital's compliance with State and federal regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Designation of Lay Caregivers."> <paragraph num="A."> <text>A hospital shall provide a patient or legal guardian of a patient with an opportunity to designate one lay caregiver before the discharge of the patient to their residence.</text> </paragraph> <paragraph num="B."> <text>The hospital’s discharge planning shall include the designation of the lay caregiver as soon as practicable in the discharge planning process.</text> </paragraph> <paragraph num="C."> <text>If a patient or legal guardian of a patient declines to designate a lay caregiver, the hospital shall:</text> <paragraph num="(1)"> <text>Document the decision in the patient’s medical record; and</text> </paragraph> <paragraph num="(2)"> <text>Be deemed to be in compliance with this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a patient or legal guardian of a patient designates a lay caregiver the hospital shall record in the patient’s medical record:</text> <paragraph num="(1)"> <text>The designation of the lay caregiver;</text> </paragraph> <paragraph num="(2)"> <text>The relationship of the lay caregiver to the patient; and</text> </paragraph> <paragraph num="(3)"> <text>The name, telephone number, and address of the lay caregiver.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Release of Medical Information.</text> <paragraph num="(1)"> <text>If the patient designates a lay caregiver, the hospital shall request the patient or legal guardian to consent in writing to release medical information to the lay caregiver. The release of records shall be in accordance with:</text> <paragraph num="(a)"> <text>The hospital’s procedures for releasing personal health information; and</text> </paragraph> <paragraph num="(b)"> <text>All applicable federal and State laws.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a patient or legal guardian of a patient declines to consent to the release of medical information to the lay caregiver, the hospital is not required to:</text> <paragraph num="(a)"> <text>Provide to the lay caregiver the notice required under Health-General Article, §19-382, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Consult with the lay caregiver or provide to the lay caregiver information contained in the discharge plan issued under Health-General Article, §19-383, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A patient or a legal guardian of the patient may change the designation of a lay caregiver in the event the lay caregiver becomes incapacitated.</text> </paragraph> <paragraph num="G."> <text>Regardless of the desire of the patient or legal guardian of the patient, the designated lay caregiver is not obligated to perform any aftercare for the patient.</text> </paragraph> <paragraph num="H."> <text>A patient or legal guardian is not required to designate a lay caregiver.</text> </paragraph> <paragraph num="I."> <text>Hospital Obligations.</text> <paragraph num="(1)"> <text>If a patient or legal guardian of a patient designates a lay caregiver, the hospital shall notify the lay caregiver as soon as practicable of the discharge of the patient or the patient’s transfer to another hospital, licensed health care facility or other residential facility.</text> </paragraph> <paragraph num="(2)"> <text>As soon as practicable before the discharge of a patient, the hospital shall attempt to:</text> <paragraph num="(a)"> <text>Consult with the patient’s lay caregiver to prepare the lay caregiver for the patient’s aftercare; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a discharge plan that describes the aftercare needs of the patient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The hospital shall make reasonable attempts to consult with the lay caregiver.</text> </paragraph> <paragraph num="(4)"> <text>The inability of the hospital to consult with a lay caregiver may not interfere with, delay, or otherwise affect the medical care provided to the patient or the patient’s planned discharge.</text> </paragraph> <paragraph num="(5)"> <text>The hospital shall document successful or unsuccessful attempts to contact the lay caregiver.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Discharge Planning Requirements. Regardless of the request for the designation of a lay caregiver, the hospital shall comply with all discharge planning requirements in:</text> <paragraph num="(1)"> <text>Regulation .27 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The standards imposed under the hospital’s accreditation by a State-approved accreditation organization; and</text> </paragraph> <paragraph num="(3)"> <text>42 CFR §482.43.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The designation of a lay caregiver may not:</text> <paragraph num="(1)"> <text>Interfere with the rights of an agent to make health care decisions under Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Create a private right of action against a hospital, a hospital employee, or a duly authorized agent of a hospital or otherwise supersede or replace existing rights or remedies under any other State or federal law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Patient Rights."> <paragraph num="A."> <text>A hospital shall develop a listing of the rights of patients that is consistent with the requirements of:</text> <paragraph num="(1)"> <text>The Joint Commission;</text> </paragraph> <paragraph num="(2)"> <text>Health-General Article, §19-342, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>42 CFR §482.13.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital’s patient rights shall at minimum address:</text> <paragraph num="(1)"> <text>Patient privacy and confidentiality;</text> </paragraph> <paragraph num="(2)"> <text>Informed decision making and informed consent;</text> </paragraph> <paragraph num="(3)"> <text>Visitation;</text> </paragraph> <paragraph num="(4)"> <text>Advance directives;</text> </paragraph> <paragraph num="(5)"> <text>Access to patient medical records;</text> </paragraph> <paragraph num="(6)"> <text>Complaint and grievance process;</text> </paragraph> <paragraph num="(7)"> <text>Freedom from:</text> <paragraph num="(a)"> <text>Physical or mental abuse;</text> </paragraph> <paragraph num="(b)"> <text>Neglect;</text> </paragraph> <paragraph num="(c)"> <text>Harassment; or</text> </paragraph> <paragraph num="(d)"> <text>Mistreatment;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A patient’s right to expect and receive appropriate assessment, management, and treatment of pain as an integral component of the patient’s care; and</text> </paragraph> <paragraph num="(9)"> <text>Communication in a manner the patient can understand.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All patients receiving services at the hospital, have the right to receive written copies of the hospital’s patient rights upon request.</text> </paragraph> <paragraph num="D."> <text>The hospital’s patient rights shall be easily accessible to patients and visitors.</text> </paragraph> <paragraph num="E."> <text>Hospital staff who are responsible for patient care shall:</text> <paragraph num="(1)"> <text>Receive training regarding the hospital’s patient rights; and</text> </paragraph> <paragraph num="(2)"> <text>Be able to assist patients and their families to:</text> <paragraph num="(a)"> <text>Access the services of the hospital’s patient advocacy staff;</text> </paragraph> <paragraph num="(b)"> <text>File a complaint or grievance; or</text> </paragraph> <paragraph num="(c)"> <text>Obtain a written copy of the hospital’s patient rights documents.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Maryland Health Care Decisions Act."> <text>A hospital shall comply with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-307.2, 19-308, 19-308.6, 19-308.8, 19-318—19-320, 19-323, 19-342, 19-349.1, and 19-380—19-385; Insurance Article, Title 4, Subtitle 4; Public Safety Article, §14-110.1; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 19, 1946</annotation> <annotation type="History" subtype="Administrative History">Amended effective March 20, 1959</annotation> <annotation type="History" subtype="Administrative History">Amended effective September 1, 1964</annotation> <annotation type="History" subtype="Administrative History">Regulations .03C, G, I, K; .04B, D; .05A, B; .06C; .07B, E; .08A, B; .09B, C; .10F; .11A, B; .12F amended effective February 24, 1978 (5:4 Md. R. 226)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 repealed and new Regulations .01—.10 adopted effective August 1, 1983 (10:15 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02B, .04A, .05A, .07, .08B amended; .02C, .09D, and new .10 and .11 adopted; existing .10—.20 recodified as .12—.22 as an emergency provision effective July 1, 1986 (13:15 Md. R. 1726); adopted permanently effective December 1, 1986 (13:24 Md. R. 2558)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 28, 1987 (14:26 Md. R. 2746); August 6, 1990 (17:15 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 11, 2002 (29:22 Md. R. 1721); April 21, 2008 (35:8 Md. R. 804); June 28, 2010 (37:13 Md. R. 852); April 16, 2012 (39:7 Md. R. 491); March 31, 2014 (41:6 Md. R. 378); March 27, 2017 (44:6 Md. R. 325); April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 recodified to be Regulation .03 and new Regulation .02 adopted effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D adopted effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D repealed effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and Regulation .02 recodified to be Regulation .03 effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 24, 1991 (18:12 Md. R. 1338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective February 26, 2007 (34:4 Md. R. 400)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C adopted as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-1 adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 28, 1987 (14:26 Md. R. 2746); June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B adopted effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 26, 2007 (34:4 Md. R. 400); March 31, 2014 (41:6 Md. R. 378); April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11—.20 adopted as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective December 28, 1987 (14:26 Md. R. 2746)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 repealed effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 repealed effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 adopted effective April 16, 2012 (39:7 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 adopted effective February 22, 1988 (15:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23A and C amended as an emergency provision effective June 9, 1988 (15:14 Md. R. 1653); emergency status expired December 9, 1988; adopted permanently effective December 26, 1988 (15:26 Md. R. 2982)</annotation> <annotation type="History" subtype="Administrative History">Regulations .24—.26 adopted effective December 28, 1987 (14:26 Md. R. 2746)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective March 1, 2004 (31:4 Md. R. 315); March 31, 2014 (41:6 Md. R. 378)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24C amended as an emergency provision effective May 6, 2025 (52:11 Md. R. 531); adopted permanently effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24E amended effective April 16, 2012 (39:7 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 repealed effective March 15, 2004 (31:5 Md. R. 448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 adopted effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 recodified to Regulation .27, and new Regulation .26 adopted effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective April 2, 1990 (17:6 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulations .27—.31 adopted effective August 6, 1990 (17:15 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 recodified to Regulation .32 effective August 6, 1990 (17:15 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulations .27—.31 repealed effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 adopted effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28A amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29 adopted effective March 31, 2014 (41:6 Md. R. 378)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29F adopted effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 adopted effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30A amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 adopted effective March 27, 2017 (44:6 Md. R. 325)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32D amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32-1 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32-2 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32-3 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33 adopted effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33A amended effective March 2, 2015 (42:4 Md. R. 433)</annotation> <annotation type="History" subtype="Administrative History">Regulation .34 adopted effective April 21, 2008 (35:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35 adopted effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .36 adopted effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .37 adopted effective April 23, 2018 (45:8 Md. R. 420)</annotation> </annotations> </chapter> <chapter num="02" heading="Nursing Homes"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrator” means the individual licensed by the Board of Examiners of Nursing Home Administrators who is responsible for the operation of the nursing home.</text> </paragraph> <paragraph num="(2)"> <text>“Attending physician” means an individual licensed to practice medicine in the State who:</text> <paragraph num="(a)"> <text>Admits residents to the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for the overall care of a resident.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Audiologist” means an individual who holds a Maryland license issued by the State Board of Audiologists, Hearing Aid Dealers, and Speech-Language Pathologists.</text> </paragraph> <paragraph num="(4)"> <text>“Authorized prescriber” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Certified medicine aide” means an individual who meets the requirements as stated in COMAR 10.39.01 and 10.39.03.</text> </paragraph> <paragraph num="(6)"> <text>“Certified social worker” means an individual licensed to practice as a certified social worker in this State.</text> </paragraph> <paragraph num="(7)"> <text>“Charge nurse” means the registered or licensed practical nurse who is responsible for day-to-day operations of a unit in the nursing home on which residents live.</text> </paragraph> <paragraph num="(8)"> <text>“Chemical restraint” means the administration of any drug that is used for discipline or convenience and not required to treat medical symptoms.</text> </paragraph> <paragraph num="(9)"> <text>“Comprehensive care facility” means a nursing home that admits residents requiring medical services and nursing services rendered by or under the supervision of a registered nurse, who:</text> <paragraph num="(a)"> <text>Are advanced in age; or</text> </paragraph> <paragraph num="(b)"> <text>Have a disease or a disability.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Concurrent review” means daily rounds by a licensed nurse which include:</text> <paragraph num="(a)"> <text>Appraisal and observation of all residents by the licensed nurse to determine any change in each resident’s physical or mental status;</text> </paragraph> <paragraph num="(b)"> <text>If there is a change in the resident’s physical or mental status, an evaluation by the licensed nurse of the resident’s medications, laboratory values relating to the resident, and clinical data relating to the resident, including the resident’s:</text> <paragraph num="(i)"> <text>Hydration and nutritional needs;</text> </paragraph> <paragraph num="(ii)"> <text>Skin integrity;</text> </paragraph> <paragraph num="(iii)"> <text>Noted weight changes; and</text> </paragraph> <paragraph num="(iv)"> <text>Appetite;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Evaluation of injuries sustained by the resident that result from an accident or incident involving the resident; and</text> </paragraph> <paragraph num="(d)"> <text>Any other relevant parameters affecting or reflecting the resident’s physical and mental status.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Culture change facility” means a nursing home where physical environment and operational changes have been made to establish person-valued and person-directed care activities and services.</text> </paragraph> <paragraph num="(12)"> <text>“Deficiency” means a condition existing in a nursing home or an action or inaction by the nursing home staff that results in potential for more than minimal harm, actual harm, or serious and immediate threat to one or more residents.</text> </paragraph> <paragraph num="(13)"> <text>“Dentist” means an individual licensed to practice dentistry in this State.</text> </paragraph> <paragraph num="(14)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(15)"> <text>“Dietetic service supervisor” means a person who:</text> <paragraph num="(a)"> <text>Is a qualified dietitian;</text> </paragraph> <paragraph num="(b)"> <text>Is a graduate of a dietetic technician program approved by the American Dietetic Association;</text> </paragraph> <paragraph num="(c)"> <text>Is a certified dietary manager who has successfully completed the required course and maintains certification as required by the certifying board for the Dietary Managers Association;</text> </paragraph> <paragraph num="(d)"> <text>Is a graduate of a State-approved course that provided 90 or more hours of classroom instruction in food service supervision and has experience as a supervisor in a health care institution with consultation from a dietitian; or</text> </paragraph> <paragraph num="(e)"> <text>Has training and experience in food service supervision and management in a military service equivalent in content to §B(15)(b) and (d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Dietitian-nutritionist” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Maryland Board of Dietetic Practice to practice dietetics;</text> </paragraph> <paragraph num="(b)"> <text>Has met the certifying requirements for registration as a dietitian as administered by the Commission on Dietetic Registration; and</text> </paragraph> <paragraph num="(c)"> <text>Maintains the continuing education requirements of registration.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Discharge” means the removal of a resident from a nursing home when the releasing nursing home is no longer responsible for the resident’s care.</text> </paragraph> <paragraph num="(18)"> <text>“Discipline” means the medical, rehabilitative, nursing, dietetic, activities and social service components affiliated with the operation of a nursing home.</text> </paragraph> <paragraph num="(19)"> <text>“Distinct part extended care facility” means a portion of a nursing home that is licensed as an extended care facility.</text> </paragraph> <paragraph num="(20)"> <text>“Extended care facility” means a nursing home that offers sub-acute care and provides medical treatment services for residents who require inpatient care but who do not currently require continuous hospital services.</text> </paragraph> <paragraph num="(21)"> <text>“Facility” means a nursing home.</text> </paragraph> <paragraph num="(22)"> <text>“Fire authorities” means the official fire safety agency including the State Fire Marshal or local fire marshals or fire departments as appropriate.</text> </paragraph> <paragraph num="(23)"> <text>“Full time” means 40 hours per week or the standard work week adopted by the nursing home.</text> </paragraph> <paragraph num="(24)"> <text>“Geriatric nursing assistant” means a CNA who has successfully completed the requirements for a GNA set forth in 42 CFR §§483.151—483.156 and COMAR 10.39.01.</text> </paragraph> <paragraph num="(25)"> <text>“Grant” means the award of money to an individual or an organization to:</text> <paragraph num="(a)"> <text>Study an aspect for the geriatric population; or</text> </paragraph> <paragraph num="(b)"> <text>Provide a service to nursing home residents or their families.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Health officer” means the health officer or the designated representative in each of the 23 counties and the Commissioner of Health in Baltimore City.</text> </paragraph> <paragraph num="(27)"> <text>“HVAC” means heating, ventilation and air conditioning.</text> </paragraph> <paragraph num="(28)"> <text>“Infection preventionist” means a licensed healthcare worker who:</text> <paragraph num="(a)"> <text>Manages the infection prevention and control program in the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>Has completed a minimum of 15 contact hours of infection prevention and control training that is approved by the:</text> <paragraph num="(i)"> <text>Department’s Office of Infectious Disease Epidemiology and Outbreak Response; and</text> </paragraph> <paragraph num="(ii)"> <text>Office of Health Care Quality.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Licensed bachelor social worker (LBSW)” means an individual authorized to practice bachelor social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(30)"> <text>“Licensed certified social worker (LCSW)” means an individual authorized to practice certified social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“Licensed certified social worker–clinical (LCSW-C)” means an individual authorized to practice clinical social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Licensed master social worker” means an individual authorized to practice master social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Licensed or certified professional health care practitioner” means a nurse practitioner, physician assistant, or other practitioner licensed or certified under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy as defined in Health Occupations Article, §12-101(l), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(35)"> <text>“Licensed practical nurse” means an individual authorized to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(36)"> <text>“Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control for the day-to-day operations of the nursing home.</text> </paragraph> <paragraph num="(37)"> <text>“MDS Care Area Assessment” means the investigation of triggered care areas, to determine if the care area or areas require interventions and care planning.</text> </paragraph> <paragraph num="(38)"> <text>“Medical director” means an individual licensed to practice medicine in this State who, pursuant to a written agreement, is responsible for the overall coordination of the medical care in the nursing home to ensure the adequacy and appropriateness of the medical services provided to residents and to maintain surveillance of the health status of employees.</text> </paragraph> <paragraph num="(39)"> <text>“Minimum Data Set (MDS)” means a core set of screening, clinical, and functional status elements, including common definitions and coding categories, which:</text> <paragraph num="(a)"> <text>Forms the foundation of a comprehensive assessment for all nursing home and swing bed residents; and</text> </paragraph> <paragraph num="(b)"> <text>Standardize communication about resident problems and conditions:</text> <paragraph num="(i)"> <text>Within these facilities;</text> </paragraph> <paragraph num="(ii)"> <text>Between these facilities; and</text> </paragraph> <paragraph num="(iii)"> <text>Between these facilities and outside agencies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(40)"> <text>“New nursing home” means a nursing home that does not yet have plans approved by the Department at the time of the adoption of this chapter.</text> </paragraph> <paragraph num="(41)"> <text>“NFPA” means National Fire Protection Association.</text> </paragraph> <paragraph num="(42)"> <text>“Nurse” means a licensed practical nurse or registered nurse licensed in the State as defined in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(43)"> <text>“Nurse practitioner” has the meaning stated in Health Occupations Article, §8-101(k), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(44)"> <text>“Nursing care” has the meaning stated in Health-General Article, §19-301(k), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(45)"> <text>“Nursing home” means a comprehensive care facility or extended care facility which offers nonacute inpatient care to residents:</text> <paragraph num="(a)"> <text>Who have a disease, chronic illness, condition, disability of advanced age, or terminal disease requiring maximal nursing care without continuous hospital services; and</text> </paragraph> <paragraph num="(b)"> <text>Who require medical services and nursing services rendered by or under the supervision of a licensed nurse together with convalescent, restorative, or rehabilitative services.</text> </paragraph> </paragraph> <paragraph num="(46)"> <text>“Nursing service personnel” means staff licensed or certified by the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(47)"> <text>“Occupational therapist” means an individual who is licensed by the State Board of Occupational Therapy Practice to practice occupational therapy.</text> </paragraph> <paragraph num="(48)"> <text>“Occupational therapy assistant” means an individual who is currently licensed by the State Board of Occupational Therapy Practice as an occupational therapy assistant.</text> </paragraph> <paragraph num="(49)"> <text>“Ongoing pattern” means the occurrence of any potential for more than minimal harm or greater deficiency on two consecutive on-site visits as a result of:</text> <paragraph num="(a)"> <text>Annual surveys;</text> </paragraph> <paragraph num="(b)"> <text>Follow-up visits and unscheduled visits; or</text> </paragraph> <paragraph num="(c)"> <text>Complaint investigations.</text> </paragraph> </paragraph> <paragraph num="(50)"> <text>“Paid feeding assistant” means an individual who:</text> <paragraph num="(a)"> <text>Meets the requirements of Regulation .63 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is paid by a nursing home to feed residents who are unable to perform the task themselves.</text> </paragraph> </paragraph> <paragraph num="(51)"> <text>“Physical restraint” means any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body including but not limited to:</text> <paragraph num="(a)"> <text>Leg restraints;</text> </paragraph> <paragraph num="(b)"> <text>Arm restraints;</text> </paragraph> <paragraph num="(c)"> <text>Hand mitts;</text> </paragraph> <paragraph num="(d)"> <text>Soft ties or vests;</text> </paragraph> <paragraph num="(e)"> <text>Lap cushions; and</text> </paragraph> <paragraph num="(f)"> <text>Lap trays.</text> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Physical therapist” means an individual licensed to practice physical therapy by the State Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(53)"> <text>“Physician” means an individual licensed to practice medicine in this State.</text> </paragraph> <paragraph num="(54)"> <text>“Physician assistant” has the meaning stated in Health Occupations Article, §15-101(o), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(55)"> <text>“Plan of correction” means a written response from the nursing home addressing each deficiency cited as a result of an inspection by the Department.</text> </paragraph> <paragraph num="(56)"> <text>“Positive tuberculin skin test” means a test provided as authorized by the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings.</text> </paragraph> <paragraph num="(57)"> <text>“Principal physician” means an individual licensed to practice medicine in this State who agrees to perform certain medical services under contract with a nursing home, consistent with the policies of the nursing home.</text> </paragraph> <paragraph num="(58)"> <text>“Protective device” means any device or equipment:</text> <paragraph num="(a)"> <text>That is prescribed by a physician;</text> </paragraph> <paragraph num="(b)"> <text>That limits, but does not eliminate the movement of the resident’s head, body, or limbs; and</text> </paragraph> <paragraph num="(c)"> <text>That:</text> <paragraph num="(i)"> <text>Shields a resident from self-injury;</text> </paragraph> <paragraph num="(ii)"> <text>Prevents a resident from aggravating an existing physical problem; or</text> </paragraph> <paragraph num="(iii)"> <text>Prevents a resident from precipitating a potential physical problem.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(59)"> <text>“Qualified medical record practitioner” means an individual who:</text> <paragraph num="(a)"> <text>Has:</text> <paragraph num="(i)"> <text>Received a baccalaureate degree from an accredited college or university including or supplemented by a successful completion of a course in health record administration approved by the Council on Medical Education of the American Medical Association; and</text> </paragraph> <paragraph num="(ii)"> <text>Passed the national registration examination for registered record administrators; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has:</text> <paragraph num="(i)"> <text>Received an associate of arts degree in health record technology from a college or university approved by the American Medical Association Council on Medical Education or an equivalent approved health record technology correspondence course of the American Medical Record Association; and</text> </paragraph> <paragraph num="(ii)"> <text>Passed the national accreditation examination for accredited record technicians.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(60)"> <text>“Qualified social work consultant” means an individual who:</text> <paragraph num="(a)"> <text>Is a licensed certified social worker; and</text> </paragraph> <paragraph num="(b)"> <text>Has a minimum of 3 years’ experience in social work programs in a long-term care setting within the last 5 years.</text> </paragraph> </paragraph> <paragraph num="(61)"> <text>“Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system” means the standard nationwide system to which several types of health care providers submit CMS required resident information to the National Submissions Database.</text> </paragraph> <paragraph num="(62)"> <text>“Registered nurse” means an individual licensed to practice as a registered nurse in this State.</text> </paragraph> <paragraph num="(63)"> <text>Relocation.</text> <paragraph num="(a)"> <text>“Relocation” means the movement of a resident from one room to another within:</text> <paragraph num="(i)"> <text>The same Medicare-certified nursing home;</text> </paragraph> <paragraph num="(ii)"> <text>A Medicaid-only certified nursing home; or</text> </paragraph> <paragraph num="(iii)"> <text>A licensed-only nursing home.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from:</text> <paragraph num="(i)"> <text>The distinct part of the nursing home that is a skilled nursing facility to a distinct part of the nursing home that is not a skilled nursing facility; or</text> </paragraph> <paragraph num="(ii)"> <text>A bed that is certified for Medicaid to a distinct part of the nursing home that is a skilled nursing facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(64)"> <text>“Resident” means an individual who:</text> <paragraph num="(a)"> <text>Resides in the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>Receives nursing services rendered by or under the supervision of a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(65)"> <text>“Resident activities coordinator” means an individual who:</text> <paragraph num="(a)"> <text>Is a:</text> <paragraph num="(i)"> <text>Certified therapeutic recreation specialist;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed occupational therapist; or</text> </paragraph> <paragraph num="(iii)"> <text>Licensed occupational therapy assistant; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has 2 years of experience in a social or recreational program in a licensed health care setting within the last 5 years, 1 year of which was full time in a resident activities program with guidance from an individual identified in §B(73)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(66)"> <text>Resident Assessment Instrument (RAI).</text> <paragraph num="(a)"> <text>“Resident Assessment Instrument (RAI)” means a standardized and reproducible resident assessment process based on completion of Minimum Data Set (MDS) screening items, and including the MDS Care Area Assessment process, and related process for care planning and evaluation.</text> </paragraph> <paragraph num="(b)"> <text>“Resident Assessment Instrument (RAI)” includes:</text> <paragraph num="(i)"> <text>Minimum Data Set;</text> </paragraph> <paragraph num="(ii)"> <text>MDS Care Area Assessment Process; and</text> </paragraph> <paragraph num="(iii)"> <text>RAI utilization guidelines.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Resident’s representative” means a person with the authority to act on the resident’s behalf regarding the matter at issue.</text> </paragraph> <paragraph num="(68)"> <text>“Restraint” means any physical or chemical restraint as defined in this chapter.</text> </paragraph> <paragraph num="(69)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(70)"> <text>“Serious and immediate threat” means a situation in which immediate corrective action is necessary because a deficiency has caused or is likely to cause serious injury, harm, impairment to, or death of a resident receiving care in the nursing home.</text> </paragraph> <paragraph num="(71)"> <text>“Special care unit” means a nursing home unit that provides intensive specialized care, such as respiratory, rehabilitative, dementia, or dialysis care, continuously on a 24-hour basis.</text> </paragraph> <paragraph num="(72)"> <text>“Speech-language pathologist” means an individual licensed by the State Board of Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists.</text> </paragraph> <paragraph num="(73)"> <text>“Support personnel” means an aide who:</text> <paragraph num="(a)"> <text>Is assigned to a particular service such as:</text> <paragraph num="(i)"> <text>Nursing;</text> </paragraph> <paragraph num="(ii)"> <text>Dietary;</text> </paragraph> <paragraph num="(iii)"> <text>Physical therapy; or</text> </paragraph> <paragraph num="(iv)"> <text>Occupational therapy; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has been approved by the manager of the services as having sufficient training and experience to perform the assigned duties.</text> </paragraph> </paragraph> <paragraph num="(74)"> <text>“Tuberculin skin test” means a test to diagnose tuberculosis infection using purified protein derivative (PPD) that is injected intradermally and read within 48—72 hours with results recorded in millimeters of induration.</text> </paragraph> <paragraph num="(75)"> <text>Tuberculosis in a Communicable Form.</text> <paragraph num="(a)"> <text>“Tuberculosis in a communicable form” means that an individual:</text> <paragraph num="(i)"> <text>Is presumed to have active pulmonary or laryngeal tuberculosis as evidenced by positive X-ray findings with or without positive acid-fast bacilli (AFB) sputum smear or positive AFB sputum culture; and</text> </paragraph> <paragraph num="(ii)"> <text>Has received chemotherapy for less than 14 days.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Tuberculosis in a communicable form” does not include:</text> <paragraph num="(i)"> <text>When the individual who has presumptive or confirmed active disease, has had three negative AFB smears, collected 8—24 hours apart, shows clinical improvement, and has received chemotherapy to which the strain is susceptible for at least 14 days; or</text> </paragraph> <paragraph num="(ii)"> <text>The individual who has inactive pulmonary scarring, calcification, or a normal chest X-ray.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(76)"> <text>“Two-step tuberculin skin testing” means the administration of a second tuberculin skin test 1 to 3 weeks after the initial skin test is negative, to identify individuals with a past TB infection who may now have reduced skin reactivity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, (Version 1.14, October 2016).</text> </paragraph> <paragraph num="(2)"> <text>CMS Manual System, Pub. 100-07 State Operations Provider Certification, (Transmittal 127, November 26, 2014, U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services).</text> </paragraph> <paragraph num="(3)"> <text>Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. (2014) Facility Guidelines Institute, which is incorporated in COMAR 10.07.01.02.</text> </paragraph> <paragraph num="(4)"> <text>2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (Centers for Disease Control and Prevention (CDC), Healthcare Infection Control Practices Advisory Committee (HIPAC), 2007).</text> </paragraph> <paragraph num="(5)"> <text>Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 (MMWR2005; 54, No. RR-17, Centers for Disease Control and Prevention (CDC), Atlanta, GA).</text> </paragraph> <paragraph num="(6)"> <text>Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP), (MMWR2011; 60 No. SS-07, Centers for Disease Control and Prevention (CDC), Atlanta, GA).</text> </paragraph> <paragraph num="(7)"> <text>National Fire Protection Association, NFPA 99 Health Care Facilities Code (2015 Edition).</text> </paragraph> <paragraph num="(8)"> <text>National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06.</text> </paragraph> <paragraph num="(9)"> <text>Recommended Dietary Allowances, (10th Edition, Food and Nutritional Board, Commission on Life Sciences, and National Research Council, 1989).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person may not establish, operate, or continue the operation of an existing comprehensive care facility or extended care facility without first obtaining a license from the Secretary. A license is valid for 2 years from the date of issuance, unless revoked by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Separate License Required. Separate licenses are required for facilities maintained on separate premises, even though they are operated under the same management. Separate licenses may be required for separate buildings on the same grounds.</text> </paragraph> <paragraph num="C."> <text>Other License Required. A facility having a dual function, including care of the sick requiring hospital facilities in addition to rendering other care services, is required to be licensed for each level of health care rendered.</text> </paragraph> <paragraph num="D."> <text>Posting of License Application and Instructions for Written Comment.</text> <paragraph num="(1)"> <text>At least 50 days before the anticipated date of the new license or relicensure, a facility shall conspicuously post:</text> <paragraph num="(a)"> <text>Its application for initial license or license renewal; or</text> </paragraph> <paragraph num="(b)"> <text>A notice describing where in the facility the application for licensure or relicensure may be found.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The posting shall be near the entrance, in a manner which is plainly visible and easily read by the public.</text> </paragraph> <paragraph num="(3)"> <text>The posting shall include instructions for filing written comments to the Department.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Posting of License. A facility shall conspicuously post its license on the premises, at or near the entrance, in a manner which is plainly visible and easily read by the public.</text> </paragraph> <paragraph num="F."> <text>Provisional License.</text> <paragraph num="(1)"> <text>The Secretary may issue a license to a nursing home or an extended care facility for less than a 24-month period under any of the following conditions:</text> <paragraph num="(a)"> <text>A facility has substantial deficiencies which in the opinion of the Department do not constitute a serious or immediate threat to the health, life, or safety of the residents and the facility has submitted a plan of correction to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department;</text> </paragraph> <paragraph num="(b)"> <text>A facility has substantial deficiencies which in the opinion of the Department have no immediate adverse effect on the life, safety, or health status of residents but require construction or remodeling to correct, and the facility has made a bona fide commitment to correct the deficiencies by a required date;</text> </paragraph> <paragraph num="(c)"> <text>Departmental administrative delays have occurred which are beyond the control of the facility;</text> </paragraph> <paragraph num="(d)"> <text>If new construction is completed to the point of being able to provide all necessary services to its residents but certain substantial items of equipment for optional services are temporarily lacking, which in the opinion of the Department will have no immediate adverse effect on the safety or health of its residents; or</text> </paragraph> <paragraph num="(e)"> <text>Licensing revocation proceedings are pending against the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A provisional license shall be based upon the facility's written plan of correction addressing every deficiency existing at the time of licensure, including specific corrective action with the anticipated date of correction for each deficiency. The Department's decision to issue a provisional license shall be based upon the reasonableness of the plan and the facility's compliance history.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary shall issue only one license of less than 24 months during a given licensure period unless the facility can demonstrate that extenuating circumstances exist which are beyond the control of the facility in meeting a required deadline or, where necessary, to allow the Department to coordinate and unify its annual licensing dates with federal certification dates.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Waiver of Provisions. If a facility experiences practical difficulties or unnecessary hardships in complying with the provisions of this chapter, and can demonstrate that granting a waiver will not adversely affect the health and safety of its residents, the Secretary may waive any provision of this chapter. A waiver granted to a facility is effective for the period specified in the waiver. A waiver may be revoked at any time if a facility violates a condition of the waiver or if it appears to the Secretary that the health or safety of residents residing in the facility would be adversely affected by the continuation of the waiver.</text> </paragraph> <paragraph num="H."> <text>Plan of Correction Required.</text> <paragraph num="(1)"> <text>A facility shall submit a written plan of correction to the Department within 10 working days of the date that a facility receives written notice of deficiencies from the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Department may not issue a license to a facility until the facility submits a plan of correction that is acceptable to the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>Application for License.</text> <paragraph num="(1)"> <text>An applicant desiring to open a comprehensive care facility or an extended care facility shall file an application with the Secretary, on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>An application for a license shall be filed with the Department at least 60 days before the anticipated issuance of the license.</text> </paragraph> <paragraph num="(3)"> <text>Applications on behalf of a legal entity shall be made by the senior officer or other senior official and a second official, if any.</text> </paragraph> <paragraph num="(4)"> <text>All members of the governing body shall be disclosed, with their business addresses.</text> </paragraph> <paragraph num="(5)"> <text>The applicant shall complete all disclosure required by the Secretary, including:</text> <paragraph num="(a)"> <text>Ownership of real property;</text> </paragraph> <paragraph num="(b)"> <text>The identity of any management company that will operate or contract with the applicant to operate the facility;</text> </paragraph> <paragraph num="(c)"> <text>Ownership of equipment; and</text> </paragraph> <paragraph num="(d)"> <text>The names of persons holding 5 percent or greater of stocks or assets.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The applicant for a license to operate a comprehensive care facility or an extended care facility is the licensee. Responsibility for conformance with licensing standards and regulations rests upon the licensee. Those licensees requesting participation in the Maryland Medicaid program shall comply with the Medicaid contract.</text> </paragraph> <paragraph num="(7)"> <text>Additional Requirements.</text> <paragraph num="(a)"> <text>The Secretary shall require an applicant for licensure to submit to the Secretary the following information concerning the applicant’s:</text> <paragraph num="(i)"> <text>Past or current operation of a nursing home, other health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland, assisted living program, residential service agency or other licensed in-home care service, or licensed community program for individuals with developmental disabilities, substance abuse, or mental health needs, located within or outside this State;</text> </paragraph> <paragraph num="(ii)"> <text>Ability to comply with the applicable standards of medical and nursing care and applicable State or federal laws and regulations by disclosing the identities of its medical director, director of nursing, and administrator, and by providing the nursing home’s quality assurance plan, as required in Regulation .66 of this chapter; and</text> </paragraph> <paragraph num="(iii)"> <text>Financial and administrative ability to maintain a nursing home in compliance with these regulations, including submission of an audited financial statement, whether or not the applicant ever operated a nursing home, related institution, or other health care facility.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Secretary shall:</text> <paragraph num="(i)"> <text>Approve the application unconditionally;</text> </paragraph> <paragraph num="(ii)"> <text>Approve the application with conditions, such as requiring the applicant to use the services of a management firm, requiring a staffing pattern, or limiting admissions to the facility; or</text> </paragraph> <paragraph num="(iii)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A person who disagrees with the decision of the Secretary to deny a license application under this section may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Restrictions of License.</text> <paragraph num="(1)"> <text>Nomenclature. A nursing home licensed under this regulation may not use the word “hospital” in its title.</text> </paragraph> <paragraph num="(2)"> <text>Zoning. If a proposed facility is to be located in a political subdivision requiring zoning approval, the zoning authority's written approval shall be submitted to the Department before the Department's approval of the first drawings which are submitted.</text> </paragraph> <paragraph num="(3)"> <text>Local Law or Ordinance, Where Applicable. A nursing home located in a political subdivision which requires it to meet certain standards shall submit proof to the Secretary that the nursing home meets local laws, regulations, or ordinances at the time application for license is submitted.</text> </paragraph> <paragraph num="(4)"> <text>Transfer or Assignment of License.</text> <paragraph num="(a)"> <text>If the sale, transfer, assignment, or lease of a nursing home causes a change in the person or persons who control or operate the nursing home, the nursing home shall be considered a “new nursing home” and the licensee shall conform to all regulations applicable at the time of transfer of operations.</text> </paragraph> <paragraph num="(b)"> <text>The transfer of any stock which results in a change of the person or persons who control the nursing home, or a 25 percent or greater change in any form of ownership interest, constitutes a sale.</text> </paragraph> <paragraph num="(c)"> <text>For purposes of Life Safety Code enforcement, the nursing home is considered to be an existing nursing home if it has been in continuous use as a nursing home. Waivers may be granted under Regulation .03F of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Return of License to the Secretary of Health. The current license shall immediately become void and shall be returned to the Secretary if the:</text> <paragraph num="(a)"> <text>Nursing home is sold, leased, or discontinued;</text> </paragraph> <paragraph num="(b)"> <text>Operation moved to a new location; or</text> </paragraph> <paragraph num="(c)"> <text>License is revoked.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensed Bed Capacity."> <paragraph num="A."> <text>A facility may exceed its licensed bed capacity only if the Department:</text> <paragraph num="(1)"> <text>Requests that the facility exceed its licensed bed capacity; or</text> </paragraph> <paragraph num="(2)"> <text>Approves a request from a facility to exceed its licensed bed capacity.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Departmental Request of Facility to Exceed Capacity. If the Department requests a facility to exceed its licensed bed capacity, the written request is to include the:</text> <paragraph num="(1)"> <text>Circumstances that prompted the Department to make the request;</text> </paragraph> <paragraph num="(2)"> <text>Conditions under which the licensed bed capacity may be exceeded; and</text> </paragraph> <paragraph num="(3)"> <text>Number of residents by which the facility's licensed capacity may be exceeded.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Request for Departmental Permission to Exceed Capacity.</text> <paragraph num="(1)"> <text>If an emergency situation exists, a facility may request permission from the Department to exceed its licensed bed capacity to help resolve the emergency situation.</text> </paragraph> <paragraph num="(2)"> <text>The written request shall include the:</text> <paragraph num="(a)"> <text>Circumstances or reasons for the request;</text> </paragraph> <paragraph num="(b)"> <text>Identity of any resident involved;</text> </paragraph> <paragraph num="(c)"> <text>Beginning and ending dates for which the request is made; and</text> </paragraph> <paragraph num="(d)"> <text>Documentation of any objection by a resident affected by the request, or by the resident's personal representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The nursing home shall:</text> <paragraph num="(a)"> <text>Submit the written request to the Office of Licensing and Certification Programs; and</text> </paragraph> <paragraph num="(b)"> <text>Make the request for a term not to exceed 30 days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Before reaching its decision on the request, the Department shall consider the:</text> <paragraph num="(a)"> <text>Needs of the resident whose admission is proposed;</text> </paragraph> <paragraph num="(b)"> <text>Ability of the facility to care for the resident properly;</text> </paragraph> <paragraph num="(c)"> <text>Likely effect of the admission on the comfort and care of the other residents in the facility; and</text> </paragraph> <paragraph num="(d)"> <text>Evidence that exceeding licensed capacity would help resolve the emergency situation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Required Resident Accommodations. Before a facility may admit a resident that causes the facility to exceed its licensed bed capacity, the facility shall:</text> <paragraph num="(a)"> <text>Provide the following equipment for the exclusive use of the resident:</text> <paragraph num="(i)"> <text>Electronic nurses call system or hand bell,</text> </paragraph> <paragraph num="(ii)"> <text>Privacy curtain or screen,</text> </paragraph> <paragraph num="(iii)"> <text>Storage space for belongings, and</text> </paragraph> <paragraph num="(iv)"> <text>A bed, at least 36 inches wide, sturdy and in good repair;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Meet any square footage requirements under this chapter for a room; and</text> </paragraph> <paragraph num="(c)"> <text>Meet any other condition that the Department may require.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Admission. When a facility is permitted to exceed its licensed bed capacity under this section, the facility may not admit a resident to the facility until each resident admitted under permission granted under this section has:</text> <paragraph num="(a)"> <text>Been placed in the facility as part of the facility's permanent resident population; or</text> </paragraph> <paragraph num="(b)"> <text>Found other placement that is acceptable to the resident.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Rights of Applicant if License Denied or Revoked."> <paragraph num="A."> <text>Denial of License — Proposed Facility. The Secretary shall inform the applicant of the reasons for refusal to issue a license.</text> </paragraph> <paragraph num="B."> <text>Revocation of License.</text> <paragraph num="(1)"> <text>The Secretary may, for cause shown, revoke or refuse to reissue any license issued by the Secretary. The Secretary shall consider the following factors in deciding whether a facility's license should be revoked:</text> <paragraph num="(a)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(b)"> <text>The degree of risk to the residents posed by the deficiencies;</text> </paragraph> <paragraph num="(c)"> <text>The compliance history of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>Background of the owner and management, including the owner's and management's experience in operating facilities and other businesses.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee shall have the right to a hearing before revocation of the facility's license. The hearing shall be held after 10 days notice to the licensee, and the licensee shall have an opportunity to be represented by counsel at the hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspection by Secretary."> <paragraph num="A."> <text>Open at all Times for Inspection. Licensed nursing homes and any premises that an applicant for a license proposes to operate shall be open at all times to inspection by the Secretary and by any agency designated by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Site Visits and Surveys.</text> <paragraph num="(1)"> <text>The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year.</text> </paragraph> <paragraph num="(2)"> <text>All surveys shall be unannounced.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Records and Reports. Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe and all these records and reports shall be open to inspection by the Secretary. Upon the written request of the Secretary or the Secretary's designee, the licensee shall provide immediately to the Secretary, photocopies of records and reports, including the clinical records of residents. The Department, upon request, shall reimburse the licensee for the cost of photocopying all records and reports requested under this section.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall have the authority to immediately restrict admissions in accordance with the provisions of Health-General Article, §19-328, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="New Construction, Conversion, Alteration, or Addition."> <paragraph num="A."> <text>Submission of Plans.</text> <paragraph num="(1)"> <text>The architect or professional engineer of record shall submit stamped and sealed final construction drawings to the Department.</text> </paragraph> <paragraph num="(2)"> <text>The architect or professional engineer of record shall submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations for construction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Plan Approval.</text> <paragraph num="(1)"> <text>A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until the architect or professional engineer of record submits stamped and sealed final construction drawings for Department record and provisional approval in accordance with §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The architect or professional engineer of record shall also submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>New Construction.</text> <paragraph num="(1)"> <text>A new nursing home shall satisfy the review of the Maryland Health Care Commission for the:</text> <paragraph num="(a)"> <text>Establishment of a new nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>Increase or decrease in capacity of an existing nursing home.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After obtaining approval by the Maryland Health Care Commission, the nursing home shall provide written verification of the approval to the Office of Health Care Quality.</text> </paragraph> <paragraph num="(3)"> <text>Verification shall include:</text> <paragraph num="(a)"> <text>Details of the proposed nursing home changes; and</text> </paragraph> <paragraph num="(b)"> <text>Written plans that describe how all residents, staff, and the general public will be kept safe for the duration of the project.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Conversion, Alteration, and Additions.</text> <paragraph num="(1)"> <text>An existing nursing home that wishes to convert, alter, modify, or add to the existing infrastructure shall notify the Office of Health Care Quality in writing.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall provide the Office of Health Care Quality with the documentation that verifies that the applicable local and State governmental authorities have approved work that was done.</text> </paragraph> <paragraph num="(3)"> <text>The nursing home shall provide additional information upon request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Administration and Resident Care."> <paragraph num="A."> <text>Responsibility.</text> <paragraph num="(1)"> <text>The licensee shall be responsible for the overall conduct of the comprehensive care facility or extended care facility and for compliance with applicable laws and regulations.</text> </paragraph> <paragraph num="(2)"> <text>The administrator shall be responsible for the implementation and enforcement of all provisions of the Patient's Bill of Rights Regulations under COMAR 10.07.09.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Delegation to Administrator.</text> <paragraph num="(1)"> <text>The licensee, if not acting as an administrator, shall appoint as administrator a responsible person who is:</text> <paragraph num="(a)"> <text>Qualified by training and experience; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed by the Board of Examiners of Nursing Home Administrators for the State.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The administrator shall:</text> <paragraph num="(a)"> <text>Be responsible for the control of the operation on a 24-hour basis; and</text> </paragraph> <paragraph num="(b)"> <text>With the exception of §B(3) of this regulation, serve full-time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>With the Department’s approval, an administrator may serve on a less than full-time basis for a maximum of two nursing facilities, one of which shall have a licensed capacity of 35 beds or fewer.</text> </paragraph> <paragraph num="(4)"> <text>The Department shall consider the following factors when deciding whether to approve an administrator to serve on a less than full-time basis:</text> <paragraph num="(a)"> <text>Geographic location of the facilities;</text> </paragraph> <paragraph num="(b)"> <text>Ownership of the facilities;</text> </paragraph> <paragraph num="(c)"> <text>Organizational structure of the facilities;</text> </paragraph> <paragraph num="(d)"> <text>Size of the facilities; and</text> </paragraph> <paragraph num="(e)"> <text>Background and experience of the administrator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Absence of Administrator.</text> <paragraph num="(1)"> <text>In the absence of the administrator, the nursing home at all times shall be under the direct and personal supervision of an experienced, trained, competent employee.</text> </paragraph> <paragraph num="(2)"> <text>When serving as relief for the administrator, the director of nursing shall designate an experienced, qualified registered nurse to direct the nursing service.</text> </paragraph> <paragraph num="(3)"> <text>The relief director of nursing shall be freed from other responsibilities.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Excessive Absenteeism of Administrator.</text> <paragraph num="(1)"> <text>If the director of nursing’s absence while covering for the administrator is having an adverse effect on resident care, the Department may require the designation of a specific registered nurse who shall be named the assistant director of nursing.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall be notified of the name of the assistant director of nursing.</text> </paragraph> <paragraph num="(3)"> <text>When the designee is replaced, the Department shall be notified of the name of the registered nurse filling the vacancy.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Character. The administrator shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be in good physical and mental health; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate a genuine interest in the well-being and welfare of residents in the nursing home.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Staffing.</text> <paragraph num="(1)"> <text>The administrator shall employ sufficient and satisfactory personnel as specified in this chapter to:</text> <paragraph num="(a)"> <text>Provide maintenance, cleaning, and housekeeping;</text> </paragraph> <paragraph num="(b)"> <text>Assist residents with eating; and</text> </paragraph> <paragraph num="(c)"> <text>Give adequate resident care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Voluntary Admissions Ceiling.</text> <paragraph num="(a)"> <text>A nursing home may request a voluntary admissions ceiling by submitting a written request to the Department to authorize a temporary restriction on resident admissions based upon anticipated bed usage.</text> </paragraph> <paragraph num="(b)"> <text>When the nursing home wishes to request that the restriction be removed, the request shall include the specific effective date and a statement that personnel staffing is sufficient to meet the State’s requirements at the designated census level.</text> </paragraph> <paragraph num="(c)"> <text>The Department shall approve the increase in beds within 72 hours following receipt of the nursing home’s documentation that the required additional staff is in position to serve the increased number of beds.</text> </paragraph> <paragraph num="(d)"> <text>Management of the nursing home may not permit the resident census to exceed the admissions ceiling without prior approval from the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Educational Program.</text> <paragraph num="(1)"> <text>The administrator shall plan an ongoing educational program to develop and improve the skills of all the nursing home’s personnel, including training related to problems and needs of the aged, ill, and disabled.</text> </paragraph> <paragraph num="(2)"> <text>The administrator shall maintain records reflecting attendance, by name and title, and training content.</text> </paragraph> <paragraph num="(3)"> <text>In-service training shall include at least:</text> <paragraph num="(a)"> <text>Prevention and control of infections;</text> </paragraph> <paragraph num="(b)"> <text>Fire prevention programs and resident related safety procedures in emergency situations or conditions;</text> </paragraph> <paragraph num="(c)"> <text>Accident prevention;</text> </paragraph> <paragraph num="(d)"> <text>Confidentiality of resident information;</text> </paragraph> <paragraph num="(e)"> <text>Preservation of resident dignity, including protection of the resident’s privacy and personal and property rights;</text> </paragraph> <paragraph num="(f)"> <text>Physical, functional, and psychosocial needs of the aged ill individuals;</text> </paragraph> <paragraph num="(g)"> <text>Receipt by each employee of appropriate orientation to the facility and its policies, and to the employee's position and duties;</text> </paragraph> <paragraph num="(h)"> <text>Approval by the Department of the orientation and training programs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Employment Records. A written application shall be on file for each employee and shall contain at least the:</text> <paragraph num="(1)"> <text>Employee’s Social Security number;</text> </paragraph> <paragraph num="(2)"> <text>Home address;</text> </paragraph> <paragraph num="(3)"> <text>Educational background;</text> </paragraph> <paragraph num="(4)"> <text>Past employment documentation with references;</text> </paragraph> <paragraph num="(5)"> <text>Past nursing home employment documentation, including any past instances of abuse of residents, theft, and fires;</text> </paragraph> <paragraph num="(6)"> <text>Verified licensure of personnel employed; and</text> </paragraph> <paragraph num="(7)"> <text>Proof of criminal background check.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Support Personnel.</text> <paragraph num="(1)"> <text>To support placement in a specific position, there shall be sufficient documentation in the employee’s record reflecting training and experience.</text> </paragraph> <paragraph num="(2)"> <text>In instances when an aide is to be assigned to a particular service such as dietary, physical therapy, or occupational therapy, the person in charge of the service shall be responsible for evaluating and approving or disapproving the qualifications.</text> </paragraph> </paragraph> <paragraph num="J."> <text>New Support Personnel.</text> <paragraph num="(1)"> <text>New support personnel shall be credited for 50 percent of their working time until the employee’s orientation program, as approved by the Department, is completed.</text> </paragraph> <paragraph num="(2)"> <text>Employee Orientation Program.</text> <paragraph num="(a)"> <text>New support personnel shall have an employee orientation program.</text> </paragraph> <paragraph num="(b)"> <text>The person in charge of the service to which the employee is assigned shall:</text> <paragraph num="(i)"> <text>Have input into the contents of the orientation program;</text> </paragraph> <paragraph num="(ii)"> <text>Determine the number of hours of orientation required for the various levels of support personnel; and</text> </paragraph> <paragraph num="(iii)"> <text>Following the period of orientation, indicate whether the employee satisfactorily completed the orientation program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The responsible department’s approval shall be in writing, signed by the appropriate department head whose license number, if applicable, shall be recorded in the record.</text> </paragraph> <paragraph num="(4)"> <text>In new facilities, the director of nursing and supervisors of dietary services, housekeeping, rehabilitation services, and social services shall be responsible for orienting the new support personnel to the nursing home policies and procedures and to the physical plant.</text> </paragraph> <paragraph num="(5)"> <text>There shall be a complete orientation for all the employees in life safety and disaster preparedness.</text> </paragraph> <paragraph num="(6)"> <text>The number of daily admissions of residents shall be controlled to allow sufficient time for on-the-job training.</text> </paragraph> <paragraph num="(7)"> <text>Before the opening of the nursing home, support personnel shall have a minimum of 2 days of orientation training.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Relief Personnel. Provision shall be made for qualified relief personnel during vacations or other relief periods.</text> </paragraph> <paragraph num="L."> <text>Availability of Information. The administrator shall make available to the Secretary such information as may be requested to insure that the facility is meeting the requirements of these and other applicable regulations.</text> </paragraph> <paragraph num="M."> <text>Except where inappropriate for safety reasons, an employee and any other individual who provides a health care service within or on the premises of the nursing home shall wear a personal identification tag that:</text> <paragraph num="(1)"> <text>States the name of the individual;</text> </paragraph> <paragraph num="(2)"> <text>States the profession or other title of the individual; and</text> </paragraph> <paragraph num="(3)"> <text>Is in a readily visible type font and size.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Employee Training on Cognitive Impairment and Mental Illness."> <paragraph num="A."> <text>The following employees shall receive a minimum of 8 hours of training on cognitive impairment and mental illness within the first 90 days of employment:</text> <paragraph num="(1)"> <text>Any employee who is licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Any employee whose job duties include assisting residents with activities of daily living.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The training on cognitive impairment and mental illness shall be designed to meet the specific needs of the nursing home’s population as determined by the staff trainer, including the following as appropriate:</text> <paragraph num="(1)"> <text>An overview of the following:</text> <paragraph num="(a)"> <text>A description of normal aging and conditions causing cognitive impairment;</text> </paragraph> <paragraph num="(b)"> <text>A description of normal aging and conditions causing mental illness;</text> </paragraph> <paragraph num="(c)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(d)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(e)"> <text>Health conditions that affect cognitive impairment;</text> </paragraph> <paragraph num="(f)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(g)"> <text>Early identification and intervention for cognitive impairment;</text> </paragraph> <paragraph num="(h)"> <text>Early identification and intervention for mental illness; and</text> </paragraph> <paragraph num="(i)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective communication including:</text> <paragraph num="(a)"> <text>The effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(b)"> <text>The effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(c)"> <text>Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and</text> </paragraph> <paragraph num="(d)"> <text>Environmental stimuli and influences on communication;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Behavioral interventions including:</text> <paragraph num="(a)"> <text>Identifying and interpreting behavioral symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Problem solving for appropriate intervention;</text> </paragraph> <paragraph num="(c)"> <text>Risk factors and safety precautions to protect the individual and other residents; and</text> </paragraph> <paragraph num="(d)"> <text>De-escalation techniques;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Making activities meaningful including:</text> <paragraph num="(a)"> <text>Understanding the therapeutic role of activities;</text> </paragraph> <paragraph num="(b)"> <text>Creating opportunities for productive, leisure, and self-care activities; and</text> </paragraph> <paragraph num="(c)"> <text>Structuring the day;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Staff and family interaction including:</text> <paragraph num="(a)"> <text>Building a partnership for goal-directed care;</text> </paragraph> <paragraph num="(b)"> <text>Understanding families' needs; and</text> </paragraph> <paragraph num="(c)"> <text>Effective communication between family and staff;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>End-of-life care including:</text> <paragraph num="(a)"> <text>Pain management;</text> </paragraph> <paragraph num="(b)"> <text>Providing comfort and dignity; and</text> </paragraph> <paragraph num="(c)"> <text>Supporting the family; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Managing staff stress including:</text> <paragraph num="(a)"> <text>Understanding the impact of stress on job performance, staff relations, and overall facility environment;</text> </paragraph> <paragraph num="(b)"> <text>Identification of stress triggers;</text> </paragraph> <paragraph num="(c)"> <text>Self-care skills;</text> </paragraph> <paragraph num="(d)"> <text>De-escalation techniques; and</text> </paragraph> <paragraph num="(e)"> <text>Devising support systems and action plans.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Employees who are not licensed, certified, or registered or who do not assist residents with activities of daily living shall receive a minimum of 2 hours of training on cognitive impairment and mental illness within the first 90 days of employment. The training shall include:</text> <paragraph num="(1)"> <text>An overview of the following:</text> <paragraph num="(a)"> <text>A description of normal aging and conditions causing cognitive impairment;</text> </paragraph> <paragraph num="(b)"> <text>A description of normal aging and conditions causing mental illness;</text> </paragraph> <paragraph num="(c)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(d)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(e)"> <text>Health conditions that affect cognitive impairment;</text> </paragraph> <paragraph num="(f)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(g)"> <text>Early identification and intervention for cognitive impairment;</text> </paragraph> <paragraph num="(h)"> <text>Early identification and intervention for mental illness; and</text> </paragraph> <paragraph num="(i)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective communication including:</text> <paragraph num="(a)"> <text>The effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(b)"> <text>The effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(c)"> <text>Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and</text> </paragraph> <paragraph num="(d)"> <text>Environmental stimuli and influences on communication; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Behavioral intervention including risk factors and safety precautions to protect the individual and other residents.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ongoing training in cognitive impairment and mental illness shall be provided annually and consist of, at a minimum:</text> <paragraph num="(1)"> <text>2 hours for employees who are licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland, or who assist residents with activities of daily living; and</text> </paragraph> <paragraph num="(2)"> <text>1 hour for all other employees.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The training that is described in this chapter may be provided through various means including:</text> <paragraph num="(1)"> <text>Classroom instruction;</text> </paragraph> <paragraph num="(2)"> <text>In-service training;</text> </paragraph> <paragraph num="(3)"> <text>Internet courses;</text> </paragraph> <paragraph num="(4)"> <text>Correspondence courses;</text> </paragraph> <paragraph num="(5)"> <text>Pre-recorded training; or</text> </paragraph> <paragraph num="(6)"> <text>Other training methods.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When the training method does not involve direct interaction between faculty and the participant, the facility shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Admission and Discharge."> <paragraph num="A."> <text>Written Policy. The nursing home shall develop written policies, consistent with this chapter and COMAR 10.07.09, to govern the nursing care, related medical, and other services that the nursing home provides regarding:</text> <paragraph num="(1)"> <text>Admissions, transfers, and discharges;</text> </paragraph> <paragraph num="(2)"> <text>Acceptable payment sources; and</text> </paragraph> <paragraph num="(3)"> <text>Medical Assistance program information.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nursing home shall make its admission and discharge policies available for review by residents, the resident’s representative, and the long-term care ombudsman.</text> </paragraph> <paragraph num="C."> <text>Discrimination Prohibited. A nursing home licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Color;</text> </paragraph> <paragraph num="(3)"> <text>National origin;</text> </paragraph> <paragraph num="(4)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(5)"> <text>Gender identity;</text> </paragraph> <paragraph num="(6)"> <text>Religion;</text> </paragraph> <paragraph num="(7)"> <text>Physical disability; or</text> </paragraph> <paragraph num="(8)"> <text>Mental disability.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Contract. Before or at admission, a contract shall be executed by the administrator and resident, guardian, or responsible agency which is consistent with the requirements of Health-General Article, §19-344, Annotated Code of Maryland, “Rights of Individuals”.</text> </paragraph> <paragraph num="E."> <text>Registry. A nursing home shall maintain a permanent resident registry in which the name of each resident is entered in chronological order with the date and number of entry.</text> </paragraph> <paragraph num="F."> <text>Admission Record. A copy of the clinical record, identification, and summary sheet described in Regulation .32 shall be used as an admission record.</text> </paragraph> <paragraph num="G."> <text>Before discharge the nursing home shall:</text> <paragraph num="(1)"> <text>Verify that the transfer and discharge is to a licensed assisted living facility and appropriate to meet the needs of the resident; and</text> </paragraph> <paragraph num="(2)"> <text>Document the verification in the resident’s medical record.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Notification of Responsible Persons When Resident Moves. When the resident is transferred from the nursing home for any reason or at time of death, the administrator or the administrator’s designee shall notify the attending physician and the:</text> <paragraph num="(1)"> <text>Private agency;</text> </paragraph> <paragraph num="(2)"> <text>Public agency; or</text> </paragraph> <paragraph num="(3)"> <text>Responsible party designated by the resident.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Restrictions on Admission and Retention of Residents. Residents may not be admitted or retained if, in the judgment of the attending physician, they are:</text> <paragraph num="(1)"> <text>Acutely ill and require medical, surgical, or nursing care beyond the capabilities of the facility; or</text> </paragraph> <paragraph num="(2)"> <text>Dangerous to themselves or others.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Resident's Representative."> <paragraph num="A."> <text>A nursing home shall recognize the authority of:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>A representative payee or other similar fiduciary; or</text> </paragraph> <paragraph num="(7)"> <text>To the extent permitted by Maryland law, any other individual, if that individual was designated by a resident who was competent at the time of designation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A facility shall require documentation or other appropriate verification of the authority of a resident's representative. A facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority:</text> <paragraph num="(1)"> <text>Stated in the instrument that grants the representative authority; or</text> </paragraph> <paragraph num="(2)"> <text>Established by State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A facility shall:</text> <paragraph num="(1)"> <text>Document in the resident's record the name of the individual, if any, with authority identified in §A of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Include the documentation in the record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Resident Care Policies."> <paragraph num="A."> <text>A nursing home shall develop written policies consistent with Regulation .11 of this chapter pertaining to:</text> <paragraph num="(1)"> <text>Physician services;</text> </paragraph> <paragraph num="(2)"> <text>Residents’ rights;</text> </paragraph> <paragraph num="(3)"> <text>Nursing services;</text> </paragraph> <paragraph num="(4)"> <text>Dietetic services;</text> </paragraph> <paragraph num="(5)"> <text>Specialized rehabilitative services including occupational therapy, physical therapy, speech pathology and audiology services;</text> </paragraph> <paragraph num="(6)"> <text>Pharmaceutical services;</text> </paragraph> <paragraph num="(7)"> <text>Laboratory and radiologic services;</text> </paragraph> <paragraph num="(8)"> <text>Dental services;</text> </paragraph> <paragraph num="(9)"> <text>Social services;</text> </paragraph> <paragraph num="(10)"> <text>Resident activities;</text> </paragraph> <paragraph num="(11)"> <text>Clinical records;</text> </paragraph> <paragraph num="(12)"> <text>Reports and action required in unusual circumstances;</text> </paragraph> <paragraph num="(13)"> <text>Utilization review;</text> </paragraph> <paragraph num="(14)"> <text>Infection control;</text> </paragraph> <paragraph num="(15)"> <text>Tuberculosis surveillance;</text> </paragraph> <paragraph num="(16)"> <text>Disaster plan;</text> </paragraph> <paragraph num="(17)"> <text>Housekeeping services, pest control, and laundry; and</text> </paragraph> <paragraph num="(18)"> <text>Resident care management.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Resident Care Policy.</text> <paragraph num="(1)"> <text>A nursing home shall develop resident care policies with the advice of:</text> <paragraph num="(a)"> <text>The principal physician or medical staff or medical director, if applicable; and</text> </paragraph> <paragraph num="(b)"> <text>At least one registered nurse.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A group of professional personnel including one or more physicians and one or more registered nurses shall review the policies at least annually.</text> </paragraph> <paragraph num="(3)"> <text>Written policies shall be kept current with the policies used to administer the nursing home.</text> </paragraph> <paragraph num="(4)"> <text>For reference purposes, copies of the resident care policies shall be readily available to all personnel responsible for resident care.</text> </paragraph> <paragraph num="(5)"> <text>The nursing home shall make its resident care policies available for review by residents, the resident’s representative, and the ombudsman.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Policies and Procedures.</text> <paragraph num="(1)"> <text>Upon the request of the Secretary or the Secretary's designee, the facility's policies and procedures shall be made available to the Secretary for onsite review.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall submit to the Department any significant substantive changes to the policies and procedures which have occurred since review of the policies and procedures within 2 weeks of implementation of the changes.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Use of Protective Device or Devices.</text> <paragraph num="(1)"> <text>A written physician's order is required for the use of a protective device or devices. This order shall be in effect for a maximum of 60 days. If continuation of the use of a protective device or devices beyond 60 days is necessary, a new order shall be written by the physician and rewritten every 60 days.</text> </paragraph> <paragraph num="(2)"> <text>The physician's order shall contain the specific type of protective device or devices to be used.</text> </paragraph> <paragraph num="(3)"> <text>The physician's order shall reflect his or her reason for ordering a protective device or devices.</text> </paragraph> <paragraph num="(4)"> <text>A resident in a protective device or devices shall be observed periodically by personnel, to ensure that the resident’s health and personal care needs are met.</text> </paragraph> <paragraph num="(5)"> <text>A resident who is in a protective device or devices may not be left in the same postural position for more than 2 consecutive hours.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Physician Services."> <paragraph num="A."> <text>Responsibility for the Resident's Care. The attending physician shall:</text> <paragraph num="(1)"> <text>Assess a new admission in a timely manner, based on a facility-developed protocol, depending on:</text> <paragraph num="(a)"> <text>The individual's medical stability;</text> </paragraph> <paragraph num="(b)"> <text>Recent and previous medical history;</text> </paragraph> <paragraph num="(c)"> <text>Presence of significant or previously unidentified medical conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Problems that cannot be handled readily by phone;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Seek, provide, and analyze needed information regarding a resident's current status, recent history, and medications and treatments, to enable safe, effective continuing care and appropriate regulatory compliance;</text> </paragraph> <paragraph num="(3)"> <text>Provide appropriate information and documentation to support a facility-determined level of care for a new admission;</text> </paragraph> <paragraph num="(4)"> <text>Provide for the authorization of admission orders in a timely manner, based on a facility-developed protocol, to enable the nursing facility to provide safe, appropriate, and timely care; and</text> </paragraph> <paragraph num="(5)"> <text>For a resident who is to be transferred to the care of another attending physician, continue to provide all necessary medical care and services pending transfer until another attending physician has accepted responsibility for the resident.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Support Resident Discharges and Transfers. The attending physician shall:</text> <paragraph num="(1)"> <text>Follow-up as needed with a physician or another health care practitioner at a receiving hospital within 24 hours of the transfer of an acutely ill or unstable resident;</text> </paragraph> <paragraph num="(2)"> <text>Provide whatever summary or documentation may be needed at the time of transfer to enable care continuity at a receiving facility and to allow the nursing facility to meet its legal, regulatory, and clinical responsibilities for a discharged individual; and</text> </paragraph> <paragraph num="(3)"> <text>Provide a pertinent medical discharge summary within 30 days of discharge or transfer of the resident.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Periodic, Pertinent On-site Visits to Residents. The attending physician or licensed or certified professional health care practitioner shall:</text> <paragraph num="(1)"> <text>Visit a resident as frequently as the resident's condition requires, consistent with reasonable facility policies;</text> </paragraph> <paragraph num="(2)"> <text>Determine the progress of each resident's condition at the time of a visit by evaluating the resident, talking with staff as needed, and reviewing relevant information, as needed;</text> </paragraph> <paragraph num="(3)"> <text>Review and respond to issues requiring a physician's expertise, including:</text> <paragraph num="(a)"> <text>The resident's current condition;</text> </paragraph> <paragraph num="(b)"> <text>The status of any acute episodes of illness since the last visit;</text> </paragraph> <paragraph num="(c)"> <text>Test results;</text> </paragraph> <paragraph num="(d)"> <text>Other actual or high-risk potential medical problems that may affect the individual's functional, physical, or cognitive status; and</text> </paragraph> <paragraph num="(e)"> <text>Staff, resident, or family questions regarding the individual's care and treatments; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At each visit, provide a legible progress note in a timely manner for placement on the chart, which includes relevant information about significant ongoing, active, or potential problems, including:</text> <paragraph num="(a)"> <text>Reasons for changing or maintaining current treatments or medications; and</text> </paragraph> <paragraph num="(b)"> <text>A plan to address relevant medical issues.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Timeliness of Visits and Progress Notes.</text> <paragraph num="(1)"> <text>Within 30 days of admission, a physician shall visit a resident, assess the resident's needs, and prescribe a regimen of medical care. After that, a physician, nurse practitioner, or physician assistant shall visit a resident every 30 days, except that a physician shall visit a resident at least every 120 days.</text> </paragraph> <paragraph num="(2)"> <text>The timeliness of visits shall be based on a facility-developed protocol, depending on:</text> <paragraph num="(a)"> <text>The resident's medical stability;</text> </paragraph> <paragraph num="(b)"> <text>Recent and previous medical history;</text> </paragraph> <paragraph num="(c)"> <text>The presence of significant or previously unidentified medical conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Problems that cannot be handled readily by phone.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The physician or licensed or certified professional health care practitioner shall maintain progress notes and make appropriate revisions to the resident's total program of care. The progress notes and revisions to the program of care shall cover, at a minimum, prognosis and changes in rehabilitation and other appropriate goals. The physician shall review and approve each program of care.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Alternate Schedule. If the physician determines that the resident's condition requires less frequent visits than described in §D of this regulation, the physician may order an alternate schedule in the resident's medical record. An alternate schedule may not be ordered for the resident's first 90 days of stay. The alternate schedule may not exceed 60 days between visits. If there is no alternate schedule approved by the physician, visits may not exceed 30-day intervals.</text> </paragraph> <paragraph num="F."> <text>Adequate Ongoing Coverage. The attending physician shall:</text> <paragraph num="(1)"> <text>Designate an alternate physician or physicians who shall respond in an appropriate, timely manner if the attending physician is unavailable;</text> </paragraph> <paragraph num="(2)"> <text>Update the facility about the attending physician's current office address, phone, fax, and pager numbers to enable appropriate, timely communications, as well as the current office address, phone, fax, and pager numbers of designated alternate physicians;</text> </paragraph> <paragraph num="(3)"> <text>Help ensure that alternate physicians provide adequate, timely support while covering and intervene with alternate physicians when informed of problems regarding coverage; and</text> </paragraph> <paragraph num="(4)"> <text>Adequately inform alternate physicians about residents with active acute conditions or potential problems that may need medical follow-up during their on-call time.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Appropriate Care of Residents. The attending physician shall:</text> <paragraph num="(1)"> <text>Perform accurate, timely, and relevant medical assessments;</text> </paragraph> <paragraph num="(2)"> <text>Properly define and describe resident symptoms and problems, clarify and verify diagnoses, relate diagnoses to resident problems, and help establish a realistic prognosis and care goals;</text> </paragraph> <paragraph num="(3)"> <text>In consultation with the facility's staff:</text> <paragraph num="(a)"> <text>Determine appropriate services and programs for a resident, consistent with diagnoses, condition, prognosis, and resident wishes;</text> </paragraph> <paragraph num="(b)"> <text>Ensure that treatments are medically necessary and appropriate in accordance with nursing facility regulatory requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Manage and document ethics issues consistent with relevant laws and regulations and with residents' wishes, including advising residents and families about formulating advance directives or other care instructions and helping identify individuals for whom aggressive medical interventions may not be indicated;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Respond in an appropriate time frame, based on a facility-developed protocol, to emergency and routine notification, to enable the facility to meet its clinical and regulatory obligations;</text> </paragraph> <paragraph num="(5)"> <text>Respond to notification of laboratory and other diagnostic test results in a timely manner, based on the resident's condition and clinical significance of the results;</text> </paragraph> <paragraph num="(6)"> <text>Analyze the significance of abnormal test results that may reflect important changes in the resident's status and explain the medical rationale for interventions or decisions not to intervene based on those results;</text> </paragraph> <paragraph num="(7)"> <text>Respond promptly to notification of, and assess and manage adequately, reported acute and other significant clinical condition changes in residents;</text> </paragraph> <paragraph num="(8)"> <text>Ensure that individuals receiving palliative care have appropriate comfort and supportive care measures; and</text> </paragraph> <paragraph num="(9)"> <text>Properly refer residents to specialty services and providers when the care needs of the resident exceed the scope of the attending physician’s knowledge and skill.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Appropriate, Timely Medical Orders. The attending physician shall:</text> <paragraph num="(1)"> <text>Provide timely medical orders based on an appropriate resident assessment, review of relevant pre-admission and post-admission information, and age-related and other pertinent risks of various medications and treatments;</text> </paragraph> <paragraph num="(2)"> <text>Provide sufficiently clear, legible written medication orders to avoid misinterpretation and potential medication errors, including:</text> <paragraph num="(a)"> <text>Medication strength and formulation, if alternate forms are available;</text> </paragraph> <paragraph num="(b)"> <text>Route of administration;</text> </paragraph> <paragraph num="(c)"> <text>Frequency and, if applicable, timing of administration; and</text> </paragraph> <paragraph num="(d)"> <text>Reason for which the medication is being given; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Institute safeguards to ensure the accuracy of verbal orders at the time the verbal orders are given and cosign the verbal orders in a timely fashion, but not later than the next visit to the resident.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Appropriate, Timely, and Pertinent Documentation. The attending physician shall:</text> <paragraph num="(1)"> <text>Provide documentation required to explain medical decisions, that promote effective care and allow a nursing facility to comply with relevant legal and regulatory requirements; and</text> </paragraph> <paragraph num="(2)"> <text>Complete death certificates in a timely fashion, including all information required of a physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Medical Director — Qualifications."> <paragraph num="A."> <text>Medical Director Qualifications. The nursing home shall:</text> <paragraph num="(1)"> <text>Designate a medical director who has at least the following qualifications:</text> <paragraph num="(a)"> <text>A current license as a physician in this State;</text> </paragraph> <paragraph num="(b)"> <text>At least 2 years of experience or specialized training in the medical care of geriatric or chronically ill and impaired residents; and</text> </paragraph> <paragraph num="(c)"> <text>Successful completion of a curriculum in physician management or administration from:</text> <paragraph num="(i)"> <text>AMDA: The Society for Post-Acute and Long-Term Care Medicine; or</text> </paragraph> <paragraph num="(ii)"> <text>A curriculum approved by the Department or its designee;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have a written agreement with a medical director that specifies the medical director's duties and roles and the authority to adequately discharge those responsibilities; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a copy of the medical director’s credentials to the Department upon a change in the medical director.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The requirement specified in §A(1)(c) of this regulation becomes effective 3 years after the effective date of this regulation, but the medical director shall begin the educational process in physician management or administration within the first year from the date of employment as a medical director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Medical Director — Responsibilities."> <paragraph num="A."> <text>General Responsibilities. The medical director is responsible for:</text> <paragraph num="(1)"> <text>Overall coordination, execution, and monitoring of physician services;</text> </paragraph> <paragraph num="(2)"> <text>Monitoring and evaluating the health care services and outcomes, including clinical and physician services provided to the nursing home’s residents; and</text> </paragraph> <paragraph num="(3)"> <text>Designating an alternate medical director with sufficient training and experience to perform the responsibilities of the medical director as described in the regulations of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Practitioner Oversight. The medical director shall:</text> <paragraph num="(1)"> <text>Oversee all physicians and other licensed or certified professional health care practitioners who provide health care to the facility's residents;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that there is a procedure for the review of the practitioners' credentials and the granting of privileges for licensed or certified professional health care practitioners who treat residents of the nursing facility; and</text> </paragraph> <paragraph num="(3)"> <text>Recommend rules governing the performance of physicians and other licensed or certified professional health care practitioners who admit residents to the facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Defining the Scope of Medical Services.</text> <paragraph num="(1)"> <text>The medical director, in collaboration with the facility, shall recommend written policies and procedures that are approved by the licensee, delineating the scope of physician services and medical care.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall make these policies and procedures available to a resident or resident's representative upon admission and whenever a substantive change is made.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ensuring Physician Accountability. The medical director, in collaboration with the facility, shall recommend policies and procedures that cover essential physician responsibilities to the residents and the facility, including:</text> <paragraph num="(1)"> <text>Accepting responsibility for the care of residents;</text> </paragraph> <paragraph num="(2)"> <text>Supporting resident discharges and transfers;</text> </paragraph> <paragraph num="(3)"> <text>Making periodic, pertinent resident visits in the facility;</text> </paragraph> <paragraph num="(4)"> <text>Providing adequate ongoing medical coverage;</text> </paragraph> <paragraph num="(5)"> <text>Providing appropriate resident care;</text> </paragraph> <paragraph num="(6)"> <text>Providing appropriate, timely medical orders;</text> </paragraph> <paragraph num="(7)"> <text>Providing appropriate, timely, and pertinent documentation;</text> </paragraph> <paragraph num="(8)"> <text>Advising residents and families about formulating advance directives; and</text> </paragraph> <paragraph num="(9)"> <text>Any other responsibilities as determined by the facility and the medical director.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Quality Assurance. The medical director shall actively participate in the nursing home’s quality improvement process. Participation shall include:</text> <paragraph num="(1)"> <text>Regular reports and attendance at the nursing home’s quality improvement committee meetings; and</text> </paragraph> <paragraph num="(2)"> <text>Routine participation in ongoing facility efforts to improve the overall quality of the clinical care, including facility efforts to evaluate and address the causes of various care-related problems and deficiencies cited by the Office of Health Care Quality.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Employee Health Oversight. The nursing home, in consultation with the medical director and other physicians, if necessary, shall establish and maintain surveillance of the health status of employees, including:</text> <paragraph num="(1)"> <text>Advising on the development and execution of an employee health program, which shall include provisions for determining that employees are free of communicable diseases according to current accepted standards of practice; and</text> </paragraph> <paragraph num="(2)"> <text>Ensuring that the facility plans and implements required immunization programs.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Other Related Duties. The medical director shall perform other essential duties related to clinical care and physician practices, including:</text> <paragraph num="(1)"> <text>Advising the administrator and the director of nursing on clinical issues, including the criteria for residents to be admitted, transferred, or discharged from the nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>Working with the nursing facility to establish appropriate relationships with area hospitals and other pertinent institutions to improve care of the residents;</text> </paragraph> <paragraph num="(3)"> <text>Advising and consulting with the nursing facility staff regarding communicable diseases, infection control, and isolation procedures, and serving as a liaison with local health officials and public health agencies that have policies and programs that may affect the nursing facility's care and services to residents;</text> </paragraph> <paragraph num="(4)"> <text>Providing or arranging for temporary physician services as needed to ensure that each resident has continuous physician coverage;</text> </paragraph> <paragraph num="(5)"> <text>Participating as appropriate in facility committee projects and meetings concerning clinical care and quality improvement that require physician input; and</text> </paragraph> <paragraph num="(6)"> <text>Educating or overseeing the education of, and informing, all attending physicians about their roles, responsibilities, and applicable rules and regulations.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Medical Director Oversight Plan.</text> <paragraph num="(1)"> <text>Based upon physician and medical director responsibilities in nursing facilities, as described in this chapter, the medical director shall develop and implement a plan describing how the medical director will carry out the responsibilities for the:</text> <paragraph num="(a)"> <text>Overall monitoring, coordination, and execution of physician services and medical care to residents of the nursing facility; and</text> </paragraph> <paragraph num="(b)"> <text>Systematic review of the quality of health care, including medical and physician services, provided to the facility's residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Minimum Requirements of the Plan. The medical director oversight plan shall include, at least, a plan to ensure that physicians:</text> <paragraph num="(a)"> <text>Accept appropriate responsibility for residents under the physicians' care in the nursing facility;</text> </paragraph> <paragraph num="(b)"> <text>Provide appropriate, timely medical care consistent with widely identified medical principles relevant to the facility's population; and</text> </paragraph> <paragraph num="(c)"> <text>Provide appropriate, timely, and pertinent medical documentation and orders.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation Regarding Medical Director Activities.</text> <paragraph num="(a)"> <text>The medical director shall keep documentation regarding the medical director's activities in relation to designated responsibilities.</text> </paragraph> <paragraph num="(b)"> <text>The documentation required in this subsection may include:</text> <paragraph num="(i)"> <text>Notes;</text> </paragraph> <paragraph num="(ii)"> <text>Minutes;</text> </paragraph> <paragraph num="(iii)"> <text>Copies of faxes, letters, and telephone communications with attending physicians, other facility staff and departments, the administration, the governing body, and others regarding concerns, inquiries, and interventions.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The documentation required in this subsection shall show evidence of the medical director's interventions and follow-up of the effectiveness of those interventions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Quality Assurance Committee Minutes. Committee minutes shall reflect monthly input from the medical director regarding physician issues and general facility clinical care issues.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Nursing Home’s Responsibilities in Relation to the Nursing Home’s Medical Director."> <paragraph num="A."> <text>The nursing facility shall:</text> <paragraph num="(1)"> <text>Be responsible for working with the medical director to ensure adequate resident care and practitioner performance;</text> </paragraph> <paragraph num="(2)"> <text>Inform the physician of explicit requirements as a medical director and assist the medical director in gaining the necessary information and tools to properly execute those responsibilities; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the medical director has the necessary support and authority to perform medical director duties effectively and to hold practitioners accountable.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When the attending physician and medical director document a resident’s medical need for a particular treatment, assistive device, or equipment, the nursing home shall provide that treatment, assistive device, or equipment unless the nursing home documents in the quality assurance committee minutes the reason or reasons why the treatment, assistive device, or equipment should not be provided.</text> </paragraph> <paragraph num="C."> <text>When the attending physician and medical director agree that a particular nursing home developed protocol is required to ensure that quality medical care is delivered to the nursing home’s residents, that protocol shall be implemented unless the nursing home documents in the nursing home’s resident care committee minutes the reason or reasons why the protocol should not be implemented.</text> </paragraph> <paragraph num="D."> <text>Evaluation of Medical Director's Performance.</text> <paragraph num="(1)"> <text>The facility shall have a mechanism for evaluating the medical director's performance and for providing the medical director with feedback about that performance.</text> </paragraph> <paragraph num="(2)"> <text>The criteria for evaluation shall be based on explicit medical director responsibilities and shall facilitate the medical director's improvement and performance of functions and duties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Nursing Services."> <paragraph num="A."> <text>Organization, Policies, and Procedures.</text> <paragraph num="(1)"> <text>Nursing service personnel shall provide care appropriate to the residents’ needs with the organizational plan, authority, functions, and duties clearly defined.</text> </paragraph> <paragraph num="(2)"> <text>Nurses and support personnel shall be chosen for their training, experience, and ability.</text> </paragraph> <paragraph num="(3)"> <text>Policies and procedures shall be adopted and made available to all nursing service personnel.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Signed Agreement.</text> <paragraph num="(1)"> <text>A signed copy of the agreement between the nursing home and the director of nursing, showing the license number of the nurse, shall be filed with the Department upon:</text> <paragraph num="(a)"> <text>Application for an initial nursing home license; and</text> </paragraph> <paragraph num="(b)"> <text>A change of director of nursing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agreement shall specify the duties of the director of nursing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nursing Care 24 Hours a Day. The administrator shall employ sufficient and satisfactory licensed nursing service personnel and support personnel to:</text> <paragraph num="(1)"> <text>Be on duty 24 hours a day;</text> </paragraph> <paragraph num="(2)"> <text>Provide appropriate bedside care; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that a resident:</text> <paragraph num="(a)"> <text>Receives treatments, medications, and diet as prescribed;</text> </paragraph> <paragraph num="(b)"> <text>Receives rehabilitative nursing care as needed;</text> </paragraph> <paragraph num="(c)"> <text>Receives proper care to prevent pressure ulcers and deformities;</text> </paragraph> <paragraph num="(d)"> <text>Is kept comfortable, clean, and well-groomed;</text> </paragraph> <paragraph num="(e)"> <text>Is protected from accident, injury, and infection;</text> </paragraph> <paragraph num="(f)"> <text>Is encouraged, assisted, and trained in self-care and group activities; and</text> </paragraph> <paragraph num="(g)"> <text>Receives prompt and appropriate responses to requests for assistance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Assistance by Nursing Service Personnel. Nursing service personnel shall help the resident perform daily routine dental hygiene.</text> </paragraph> <paragraph num="E."> <text>Charge Nurse.</text> <paragraph num="(1)"> <text>At least one licensed nurse shall be:</text> <paragraph num="(a)"> <text>On duty at all times; and</text> </paragraph> <paragraph num="(b)"> <text>Be designated by the director of nursing to be in charge of the nursing activities during each tour of duty.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The charge nurse or nurses shall have the ability to recognize significant changes in the condition of residents and to take necessary action.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Charge Nurses’ Daily Rounds. The charge nurse or nurses shall make daily rounds on all nursing units for which they are responsible, performing such functions as:</text> <paragraph num="(1)"> <text>Visiting each resident;</text> </paragraph> <paragraph num="(2)"> <text>Reviewing clinical records, medication orders, resident care plans, and staff assignments; and</text> </paragraph> <paragraph num="(3)"> <text>To the degree possible, accompanying physicians when visiting residents.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Program of Restorative Nursing Care. There shall be an active program of restorative nursing care aimed at assisting each resident to achieve and maintain the individual’s highest level of independent function, including activities of daily living. This program shall include:</text> <paragraph num="(1)"> <text>Ambulation and range of motion;</text> </paragraph> <paragraph num="(2)"> <text>Maintaining good body alignment and proper positioning of bedfast residents;</text> </paragraph> <paragraph num="(3)"> <text>Encouraging and assisting residents to change positions at least every 2 hours to stimulate circulation and prevent pressure ulcers and deformities;</text> </paragraph> <paragraph num="(4)"> <text>Encouraging and assisting residents to keep active and out of bed for reasonable periods of time, within the limitations permitted by physicians’ orders;</text> </paragraph> <paragraph num="(5)"> <text>Encouraging residents to engage in resident-chosen community and independent activities and achieve independence; and</text> </paragraph> <paragraph num="(6)"> <text>Assisting residents to adjust to their disabilities and ensuring availability and use of their prosthetic and assistive devices.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Coordination of Nursing and Dietetic Services. Nursing and dietetic services shall establish an effective policy to ensure that:</text> <paragraph num="(1)"> <text>Nursing service personnel are aware of the nutritional needs and food and fluid intake of residents;</text> </paragraph> <paragraph num="(2)"> <text>Nursing service personnel provide special meals and nourishment when required;</text> </paragraph> <paragraph num="(3)"> <text>Residents’ food choices and preferences are honored as much as practical;</text> </paragraph> <paragraph num="(4)"> <text>Nursing service personnel promptly aid residents when necessary in eating;</text> </paragraph> <paragraph num="(5)"> <text>The dietetic service is informed of physicians’ diet orders and of residents’ nutrition-related issues; and</text> </paragraph> <paragraph num="(6)"> <text>Food and fluid intake of residents is observed, and deviations from normal are recorded and reported to the:</text> <paragraph num="(a)"> <text>Charge nurse;</text> </paragraph> <paragraph num="(b)"> <text>Physician; and</text> </paragraph> <paragraph num="(c)"> <text>Dietetic service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>In-Service Education Program.</text> <paragraph num="(1)"> <text>The director of nursing shall:</text> <paragraph num="(a)"> <text>Provide a continuing in-service education program for all nursing service personnel;</text> </paragraph> <paragraph num="(b)"> <text>Provide a thorough job orientation for new personnel; and</text> </paragraph> <paragraph num="(c)"> <text>Document the content of the continuing in-service education program and include the names and titles of participants.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The director of nursing shall obtain approval from the Department.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Responsibility to Report Care that Is Considered Questionable.</text> <paragraph num="(1)"> <text>If a nurse questions the care provided to any resident or believes that appropriate consultation is needed and has not been obtained, the nurse shall inform the supervisor.</text> </paragraph> <paragraph num="(2)"> <text>If indicated, the supervisor shall refer the matter to the director of nursing.</text> </paragraph> <paragraph num="(3)"> <text>If warranted, the director of nursing shall report the matter to the medical director or principal physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Nursing Services — Staffing."> <paragraph num="A."> <text>Supervisory Personnel — Nursing Homes.</text> <paragraph num="(1)"> <text>Nursing homes shall provide at least the following supervisory personnel:</text> </paragraph> <paragraph num="(2)"> <text>The director of nursing’s time is included in §A(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hours of Bedside Care — Nursing Home.</text> <paragraph num="(1)"> <text>A nursing home shall employ supervisory personnel and a sufficient number of support personnel to provide a minimum of 3 hours of bedside care per occupied bed per day, 7 days per week.</text> </paragraph> <paragraph num="(2)"> <text>Bedside hours include the care provided by:</text> <paragraph num="(a)"> <text>Registered nurses;</text> </paragraph> <paragraph num="(b)"> <text>Licensed practical nurses; and</text> </paragraph> <paragraph num="(c)"> <text>Support personnel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Only those hours which the director of nursing spends in bedside care may be counted in the 3-hour minimum requirement.</text> </paragraph> <paragraph num="(4)"> <text>The director of nursing’s time counted in bedside care shall be documented.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing in Nursing Home.</text> <paragraph num="(1)"> <text>A nursing home shall be staffed with at least one registered nurse, 24 hours per day and 7 days per week.</text> </paragraph> <paragraph num="(2)"> <text>Additional registered nurses, licensed practical nurses, and support personnel shall be employed to meet the needs of all the residents admitted. The nursing home shall be staffed as referenced in §§A and B of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nursing Service Personnel on Duty. The ratio of nursing service personnel on duty providing bedside care to residents may not at any time be less than one to 15.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Nursing Services — Director of Nursing."> <paragraph num="A."> <text>Director of Nursing. The nursing home shall provide for an organized nursing service, under the direction of a full-time registered nurse.</text> </paragraph> <paragraph num="B."> <text>Termination of Services of Director of Nursing.</text> <paragraph num="(1)"> <text>If the nursing home terminates the services of the director of nursing, the nursing home immediately shall notify the Department of the termination.</text> </paragraph> <paragraph num="(2)"> <text>The name and license number of the replacement director of nursing shall be supplied to the Department as soon as employment begins.</text> </paragraph> <paragraph num="(3)"> <text>A copy of the agreement between the nursing home and the replacement shall be sent to the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Director of Nursing’s Vacancy Exceeding 30 Days. If the position of director of nursing remains vacant for a period exceeding 30 days, the nursing home’s license may be revoked unless the administrator and the governing body are able to demonstrate that they have made every effort to obtain a replacement.</text> </paragraph> <paragraph num="D."> <text>Relief for Director of Nursing.</text> <paragraph num="(1)"> <text>When the director of nursing is absent, the individual shall designate an experienced, qualified registered nurse to direct the nursing service.</text> </paragraph> <paragraph num="(2)"> <text>In a nursing home in which the director of nursing serves as relief for the administrator, the director of nursing shall designate a specific registered nurse who shall be in charge of the nursing service while the director of nursing covers for the administrator.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Responsibilities of the Director of Nursing. The responsibilities of the director of nursing shall include:</text> <paragraph num="(1)"> <text>Assisting in the development and updating of statements of nursing philosophy and objectives to define the type of nursing care the nursing home shall provide;</text> </paragraph> <paragraph num="(2)"> <text>Preparation of written job descriptions for nursing service personnel;</text> </paragraph> <paragraph num="(3)"> <text>Planning to meet the total nursing needs of residents to be met and recommending the assignment of a sufficient number of supervisory and support personnel for each tour of duty;</text> </paragraph> <paragraph num="(4)"> <text>Development and maintenance of nursing service policies and procedures to implement the program of care;</text> </paragraph> <paragraph num="(5)"> <text>Participation in the coordination of resident services through appropriate staff committee meetings on issues relating to:</text> <paragraph num="(a)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Infection control;</text> </paragraph> <paragraph num="(c)"> <text>Resident care policies;</text> </paragraph> <paragraph num="(d)"> <text>Quality assurance programs; and</text> </paragraph> <paragraph num="(e)"> <text>Departmental meetings;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Cooperation with administration in planning the orientation program and the staff development program to upgrade the competency of personnel;</text> </paragraph> <paragraph num="(7)"> <text>Ensuring that nursing personnel understand the philosophy and meet the objectives;</text> </paragraph> <paragraph num="(8)"> <text>Participation in planning and budgeting for nursing services;</text> </paragraph> <paragraph num="(9)"> <text>Establishment of a procedure to ensure that nursing service personnel, including private duty nurses, have valid and current Maryland licenses;</text> </paragraph> <paragraph num="(10)"> <text>Execution of resident care policies unless delegated to the principal physician or medical director;</text> </paragraph> <paragraph num="(11)"> <text>Participation in the selection of prospective admissions to ensure that the nursing home’s staff is capable of meeting the needs of all residents admitted;</text> </paragraph> <paragraph num="(12)"> <text>Coordination of the interdisciplinary resident care management efforts; and</text> </paragraph> <paragraph num="(13)"> <text>Supervision of certified medicine aides to ensure that the aides act within the limitations and restrictions placed on them.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Delegation of Responsibilities. The director of nursing shall make clear any authority delegated to another staff member.</text> </paragraph> <paragraph num="G."> <text>Daily Rounds — Director of Nursing.</text> <paragraph num="(1)"> <text>Although daily rounds are primarily the responsibility of the charge nurse or nurses, the director or assistant director of nursing shall periodically make clinical rounds to nursing units, randomly reviewing clinical records, medication orders, resident care plans, and staff assignments and visiting residents.</text> </paragraph> <paragraph num="(2)"> <text>Upon request, the director or assistant director of nursing may accompany physicians visiting residents.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Director of Nursing’s Continuing Education. The director of nursing shall assume responsibility for maintaining professional competence of staff through their participation in education programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Dietetic Services."> <paragraph num="A."> <text>Services Provided. Services may be provided directly by the facility or the facility may contract with a food management company, a caterer, or another facility. The facility and the food management company (or caterer or facility providing service) shall comply with these regulations. Food service personnel shall comply with COMAR 10.15.03 Food Service Facilities.</text> </paragraph> <paragraph num="B."> <text>Supervision.</text> <paragraph num="(1)"> <text>In a nursing home with more than 50 beds, overall supervisory responsibilities for the food service department and food production shall be assigned to a full-time qualified dietetic service supervisor. It shall be the responsibility of the supervisor to delegate relief duties to an individual qualified to serve as relief as stated in Regulation .09I of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>In a nursing home with 50 or fewer beds, exceptions may be made by the Department to allow the supervisor to share cooking responsibilities with the full-time cook.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Consultation.</text> <paragraph num="(1)"> <text>If the supervisor is not a licensed registered dietitian, the individual shall receive regularly scheduled consultation from a licensed registered dietitian. In all instances sufficient consultation shall be provided to fulfill all required responsibilities.</text> </paragraph> <paragraph num="(2)"> <text>There shall be a signed agreement between the facility and the consultant dietitian specifying hours and frequency of service responsibilities, and registration number if applicable.</text> </paragraph> <paragraph num="(3)"> <text>Consultation services shall be documented by written reports.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staffing.</text> <paragraph num="(1)"> <text>A sufficient number of food service personnel shall be employed to perform efficiently the functions of the food and nutrition service and meet the dietary needs of the residents.</text> </paragraph> <paragraph num="(2)"> <text>Working hours shall be scheduled to ensure that the nutritional needs of the residents are met.</text> </paragraph> <paragraph num="(3)"> <text>Nursing, housekeeping, laundry, or other personnel may not be used as food service staff. Exceptions, such as in a culture change setting, shall be based on the written approval of the Department. The kitchen may not be used for any purpose other than the preparation of food.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Adequacy of Diet.</text> <paragraph num="(1)"> <text>The food and nutritional needs of residents shall be met in accordance with physicians’ orders.</text> </paragraph> <paragraph num="(2)"> <text>To the extent medically possible, the “Recommended Dietary Allowances” of the Food and Nutrition Board, Commission on Life Sciences, and National Research Council, adjusted for age, sex, and activity, shall be observed.</text> </paragraph> <paragraph num="(3)"> <text>The “Diet Manual for Long-Term Care Residents”, as published by the Department, or any other similar reference material that contains food allowances and guides for regular and therapeutic diets, shall be used.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Therapeutic Diets. Therapeutic diets shall be planned, prepared, and served as prescribed by the attending physician:</text> <paragraph num="(1)"> <text>Therapeutic diets shall be planned by a licensed registered dietitian;</text> </paragraph> <paragraph num="(2)"> <text>Preparation and serving shall be supervised by a qualified dietetic supervisor; and</text> </paragraph> <paragraph num="(3)"> <text>A current diet manual shall be available to medical, nursing, and dietetic staff.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Frequency and Quality of Meals.</text> <paragraph num="(1)"> <text>At least three meals or their equivalent shall be offered daily, at regular times, with not more than 14-hour intervals between the substantial evening meal and breakfast.</text> </paragraph> <paragraph num="(2)"> <text>A substantial evening meal is an offering of three or more menu items at one time, one of which includes a high quality protein such as meat, fish, eggs, or cheese. This meal represents at least 20 percent of the day’s total nutritional requirements.</text> </paragraph> <paragraph num="(3)"> <text>To the extent medical orders permit, bedtime nourishments shall be offered routinely to all residents.</text> </paragraph> <paragraph num="(4)"> <text>If a four or five meal a day plan is used, the meal pattern to provide this plan shall be approved by the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Advance Planning and Posting of Menus.</text> <paragraph num="(1)"> <text>Residents shall be given the opportunity to participate in planning menus. Menus shall be written at least 1 week in advance.</text> </paragraph> <paragraph num="(2)"> <text>The current week’s basic menu shall be posted in one or more easily accessible places in the food services department and in the common areas.</text> </paragraph> <paragraph num="(3)"> <text>Menus shall include alternatives of similar nutritive value that give residents the opportunity to choose meals that they prefer. The dietary preferences of a resident shall be ascertained, including preferences arising from a resident’s religious, cultural, and ethnic heritage, and efforts shall be made to meet those preferences.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Menus Served as Planned. Food sufficient to meet the nutritional needs of patients shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value.</text> </paragraph> <paragraph num="J."> <text>Retention of Records. Menus as served and records of food purchased for consumption by patients shall be filed on the premises for a period of 30 days.</text> </paragraph> <paragraph num="K."> <text>Preparation of Food.</text> <paragraph num="(1)"> <text>Foods shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperatures, in a form to meet individual needs.</text> </paragraph> <paragraph num="(2)"> <text>Standardized recipes adjusted to appropriate yield shall be followed. Standardized recipes are those recipes which have been tested by the nursing home or another source and that ensure consistent quality and quantity.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Resident-Directed Meal Pattern. If a resident-directed meal pattern is provided, the following is required:</text> <paragraph num="(1)"> <text>Counseling the residents regarding the risks and benefits of a resident-selected diet which is documented within the medical record; and</text> </paragraph> <paragraph num="(2)"> <text>Approval of the pattern by both the resident’s physician and a licensed registered dietitian.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Specialized Rehabilitative Services — Occupational Therapy Services, Physical Therapy Services, Speech Pathology and Audiology Services."> <paragraph num="A."> <text>Rehabilitative Services — Admission Policies. In a nursing home which does not accept residents in need of specialized rehabilitative services, the minimal acceptable restorative service shall be the restorative nursing care plan designed to maintain function or improve the resident’s ability to carry out activities of daily living as set forth in Regulation .18G, of this chapter.</text> </paragraph> <paragraph num="B."> <text>Arrangements for Services.</text> <paragraph num="(1)"> <text>If a nursing home’s admission policies include the admission of residents requiring rehabilitative services, the nursing home shall provide, or arrange for under written agreement, specialized rehabilitative services by qualified personnel, such as a physical therapist, speech-language pathologist and audiologist, and occupational therapist.</text> </paragraph> <paragraph num="(2)"> <text>Initiation of services to meet the rehabilitative needs of the resident shall occur within 48 hours, excluding Saturday, Sunday, and State and federal holidays, of the physician’s order for the specialized service.</text> </paragraph> <paragraph num="(3)"> <text>The resident may not be accepted for admission if at least one service to meet the rehabilitative needs of the resident cannot be initiated within the 48-hour period, excluding Saturday, Sunday, and State and federal holidays.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Policies and Procedures.</text> <paragraph num="(1)"> <text>Written administrative and resident care policies and procedures shall be developed for rehabilitative services by appropriate rehabilitation team members and representatives of the medical, administrative, and nursing staff.</text> </paragraph> <paragraph num="(2)"> <text>Policies shall provide for the coordination of rehabilitative services and the rehabilitative aspects of nursing.</text> </paragraph> <paragraph num="(3)"> <text>The nursing home shall make its administrative and resident care policies available for review by residents and the resident’s representative.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Written Plan of Care. Rehabilitative services shall be provided under a written plan of care, initiated by the attending physician, and developed in consultation with appropriate rehabilitation team members and the nursing service.</text> </paragraph> <paragraph num="E."> <text>Physician’s Orders.</text> <paragraph num="(1)"> <text>Specialized rehabilitative services shall be provided only on written orders of the attending physician.</text> </paragraph> <paragraph num="(2)"> <text>Orders shall include modalities to be used, frequency, and anticipated goals and shall be made a part of the resident care plan.</text> </paragraph> <paragraph num="(3)"> <text>The physician shall review with the resident or the family or resident’s representative the goals and the treatment program. The frequency of communications between the physician and the rehabilitation team members shall depend on changes in the resident and the resident’s medical status.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Progress Notes.</text> <paragraph num="(1)"> <text>Within 2 weeks of referral to specialized rehabilitative services, the rehabilitation team members shall provide the attending physician with a written report of the evaluation, including goals and progress of the resident.</text> </paragraph> <paragraph num="(2)"> <text>Progress notes related to rehabilitative services shall be written at least every 2 weeks.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Reevaluation of Resident’s Progress.</text> <paragraph num="(1)"> <text>The physician and the rehabilitation team members shall reevaluate the resident’s progress as necessary, but at least every 30 days.</text> </paragraph> <paragraph num="(2)"> <text>The physician may document on the record that the reevaluation may be less frequent but in no case may the reevaluation exceed 60 days.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Resident’s Record.</text> <paragraph num="(1)"> <text>The physician’s orders, the initial evaluations, the plan of rehabilitative care, goals, services rendered, evaluations of progress, and other pertinent information shall be:</text> <paragraph num="(a)"> <text>Recorded in the resident’s medical record; and</text> </paragraph> <paragraph num="(b)"> <text>Dated and signed by the:</text> <paragraph num="(i)"> <text>Physician ordering the service; and</text> </paragraph> <paragraph num="(ii)"> <text>Those disciplines who provided the service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The record and progress notes concerning the resident shall reflect at all times the most recent and current status of the resident, including current short-term and long-term goals.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Proof of Licensure. The facility shall maintain a file which includes proof of current licensure of all the rehabilitative services' personnel.</text> </paragraph> <paragraph num="J."> <text>Job Descriptions. Current job descriptions for all rehabilitative services personnel shall be readily available in the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Special Care Units — General."> <paragraph num="A."> <text>A nursing home which holds a current and valid operating license may establish special care units with the approval of the:</text> <paragraph num="(1)"> <text>Office of Health Care Quality; and</text> </paragraph> <paragraph num="(2)"> <text>Department’s Office of Capital Planning, Budgeting and Engineering Services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A facility may notify the Department of its intention to establish a special care unit before developing and submitting the required documents for approval as described in §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>The nursing home shall obtain Departmental approval of the following pertaining to the special care unit:</text> <paragraph num="(1)"> <text>A description and scope of services to be provided;</text> </paragraph> <paragraph num="(2)"> <text>An organization chart of the special care unit and its relationship to the rest of the nursing home;</text> </paragraph> <paragraph num="(3)"> <text>A description of staffing patterns;</text> </paragraph> <paragraph num="(4)"> <text>Qualifications, duties, and responsibilities of personnel;</text> </paragraph> <paragraph num="(5)"> <text>A quality assurance plan which includes:</text> <paragraph num="(a)"> <text>Assignment of responsibility for monitoring and evaluation activities;</text> </paragraph> <paragraph num="(b)"> <text>Identification of the predominant aspects of care provided;</text> </paragraph> <paragraph num="(c)"> <text>Identification of indicators and appropriate clinical criteria for monitoring the most important aspects of care;</text> </paragraph> <paragraph num="(d)"> <text>Establishment of thresholds (levels or trends) for the indicators that will trigger evaluation of care;</text> </paragraph> <paragraph num="(e)"> <text>Monitoring of the important aspects of care by collecting and organizing data for each indicator;</text> </paragraph> <paragraph num="(f)"> <text>Evaluation of care when thresholds are reached in order to identify opportunities to improve either care or problems;</text> </paragraph> <paragraph num="(g)"> <text>Taking actions to improve care or to correct the problems;</text> </paragraph> <paragraph num="(h)"> <text>Assessing the effectiveness of the actions, documenting the improvement in care, and assessing the quality assurance process; and</text> </paragraph> <paragraph num="(i)"> <text>Communication of the results of the monitoring and evaluation process to relevant individuals or services;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Policies and procedures, including:</text> <paragraph num="(a)"> <text>The transfer or referral of residents who require services that are not provided by the special care unit;</text> </paragraph> <paragraph num="(b)"> <text>The administration of medications that are relevant to the special care residents in the special care units;</text> </paragraph> <paragraph num="(c)"> <text>Infection control measures to minimize the transfer of infection in the special care unit;</text> </paragraph> <paragraph num="(d)"> <text>Pertinent safety practices, including the control of fire and mechanical hazards; and</text> </paragraph> <paragraph num="(e)"> <text>Preventive maintenance for equipment in the special care unit;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Protocols for obtaining specialized services, such as arterial blood gases or other STAT services;</text> </paragraph> <paragraph num="(8)"> <text>Protocols for emergency situations; and</text> </paragraph> <paragraph num="(9)"> <text>An inventory of any specialized equipment to be housed on the unit to provide services in the special care unit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A facility that has been approved to establish a special care unit shall meet all applicable requirements of this chapter.</text> </paragraph> <paragraph num="E."> <text>Physician Coordinator.</text> <paragraph num="(1)"> <text>If the facility's medical director does not have special training and experience in the discipline of the assigned special care unit, the facility shall hire a physician who is appropriately trained and experienced to provide:</text> <paragraph num="(a)"> <text>Overall medical supervision of the special care unit; and</text> </paragraph> <paragraph num="(b)"> <text>Coordination of all services for the assigned special care unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The facility shall verify the candidate's credentials before employment as physician coordinator.</text> </paragraph> <paragraph num="(3)"> <text>The physician coordinator, or a designee who meets the requirements of §E(1) of this regulation, shall:</text> <paragraph num="(a)"> <text>Respond personally or arrange for another qualified physician to respond to situations warranting medical intervention; and</text> </paragraph> <paragraph num="(b)"> <text>Be available to provide any required consultation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Staffing. The nursing home shall ensure that each unit is sufficiently staffed with qualified personnel to provide appropriate treatment and meet the care needs of the residents.</text> </paragraph> <paragraph num="G."> <text>Nursing Services.</text> <paragraph num="(1)"> <text>The director of nursing shall designate a registered nurse who has education, training, and experience in caring for the needs of the special care residents to coordinate all nursing care within the special care unit.</text> </paragraph> <paragraph num="(2)"> <text>Nursing staff shall be:</text> <paragraph num="(a)"> <text>Knowledgeable about the emotional and rehabilitative aspects of the special care unit residents; and</text> </paragraph> <paragraph num="(b)"> <text>Capable of initiating appropriate therapeutic interventions when needed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Design.</text> <paragraph num="(1)"> <text>A special care unit shall meet the general construction requirements of Regulations .08, .42, and .41 of this chapter, and the requirements in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall ensure that floor space allocated to each bed meets minimum requirements listed in Regulation .49 of this chapter, and is sufficient to accommodate the special equipment necessary to meet the needs of residents.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Radiologic and Laboratory Services. The facility shall ensure that diagnostic radiologic and clinical laboratory services are available 24 hours a day. The services may be provided through contractual arrangements with providers that meet applicable federal and State laws and regulations.</text> </paragraph> <paragraph num="J."> <text>Quality Assurance Program. The facility shall:</text> <paragraph num="(1)"> <text>Develop a quality assurance plan to monitor and evaluate the care provided in each special care unit; and</text> </paragraph> <paragraph num="(2)"> <text>Monitor and evaluate the quality and appropriateness of care provided by the special care unit as part of the facility's overall quality assurance program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Special Care Units — Respiratory Care Unit."> <paragraph num="A."> <text>A respiratory care unit shall meet the:</text> <paragraph num="(1)"> <text>General requirements established for all special care units as outlined in Regulation .23 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nursing home shall submit to the Department and obtain approval of the following:</text> <paragraph num="(1)"> <text>All documents required in Regulation .23 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Policies and procedures for all aspects of care as outlined in Regulation .23 of this chapter, and the following:</text> <paragraph num="(a)"> <text>Qualifications, duties, and responsibilities of staff, including the staff who are permitted to perform the following procedures:</text> <paragraph num="(i)"> <text>Cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(ii)"> <text>Obtaining arterial blood gas samples and their analyses;</text> </paragraph> <paragraph num="(iii)"> <text>Pulmonary function testing;</text> </paragraph> <paragraph num="(iv)"> <text>Therapeutic chest percussion and vibration;</text> </paragraph> <paragraph num="(v)"> <text>Bronchopulmonary drainage;</text> </paragraph> <paragraph num="(vi)"> <text>Coughing and breathing exercises;</text> </paragraph> <paragraph num="(vii)"> <text>Mechanical ventilatory and oxygenation support for residents; and</text> </paragraph> <paragraph num="(viii)"> <text>Aerosol, humidification, and medical gas administration;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Weaning from mechanical ventilatory support and discharge planning for residents of the respiratory care unit; and</text> </paragraph> <paragraph num="(c)"> <text>The procurement, handling, storage, and dispensing of medical gases.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Physician Coordinator. If the nursing home’s medical director does not have special training and experience in diagnosing, treating, and assessing respiratory problems, the nursing home shall employ or contract with a Board-certified pulmonologist who has the special knowledge and experience to provide:</text> <paragraph num="(1)"> <text>Overall medical supervision of the respiratory care unit; and</text> </paragraph> <paragraph num="(2)"> <text>Coordination of all services for the respiratory care unit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staffing. The nursing home shall ensure that:</text> <paragraph num="(1)"> <text>The nurse manager or the director of nursing of vent units has a background in ventilator care or is qualified in ventilator management;</text> </paragraph> <paragraph num="(2)"> <text>Respiratory care services are provided by a sufficient number of qualified personnel; and</text> </paragraph> <paragraph num="(3)"> <text>Respiratory care personnel provide respiratory care services commensurate with their documented training, experience, and competence.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Design.</text> <paragraph num="(1)"> <text>Emergency Power. The nursing home unit shall meet all applicable requirements in Regulation .46 of this chapter for emergency electrical power, including the provision of:</text> <paragraph num="(a)"> <text>Emergency lighting in the respiratory care unit where life support equipment is used; and</text> </paragraph> <paragraph num="(b)"> <text>Duplex receptacles connected to the facility's emergency generator to provide emergency power to operate life support equipment and nonflammable medical gas systems in the respiratory care unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ventilator Alarms. The facility shall ensure that each ventilator is equipped with an alarm on both the pressure valve and the volume valve for safety.</text> </paragraph> <paragraph num="(3)"> <text>Piped Medical Gas Systems.</text> <paragraph num="(a)"> <text>To service the medical gas systems, a vendor or staff shall be trained and accredited in accordance with NFPA 99 Health Care Facilities Code.</text> </paragraph> <paragraph num="(b)"> <text>The vendor or staff may provide the following services:</text> <paragraph num="(i)"> <text>Installation;</text> </paragraph> <paragraph num="(ii)"> <text>Inspection; or</text> </paragraph> <paragraph num="(iii)"> <text>Testing.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The nursing home shall ensure that all piped medical gas systems adhere to the following standards:</text> <paragraph num="(i)"> <text>NFPA 99 Health Care Facilities Code; and</text> </paragraph> <paragraph num="(ii)"> <text>NFPA 101 Life Safety Code.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The nursing home shall provide pulmonary function testing and blood gas or pulse analysis capability on-site or through contractual arrangements with providers who meet applicable State and federal laws and regulations.</text> </paragraph> <paragraph num="G."> <text>Contractual Services. When any respiratory care services are provided by an outside contractor, the facility shall:</text> <paragraph num="(1)"> <text>Approve the contractor based on the contractor's credentials, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that all contractors:</text> <paragraph num="(a)"> <text>Provide services 24 hours a day;</text> </paragraph> <paragraph num="(b)"> <text>Meet all safety requirements;</text> </paragraph> <paragraph num="(c)"> <text>Abide by all pertinent policies and procedures of the facility;</text> </paragraph> <paragraph num="(d)"> <text>Provide services in accordance with all laws and regulations governing the facility; and</text> </paragraph> <paragraph num="(e)"> <text>Participate in the monitoring and evaluation of the appropriateness of services provided as required by the facility's quality assurance program; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensure that all contractual services receive overall medical supervision and coordination by the facility's physician coordinator of the respiratory care unit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Special Care Units — Dementia Care Unit."> <paragraph num="A."> <text>A dementia care unit shall meet the:</text> <paragraph num="(1)"> <text>General requirements established for all special care units as outlined in Regulation .24 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Dementia Unit Disclosure.</text> <paragraph num="(1)"> <text>The disclosure shall be made to the Department and to any person seeking placement or receiving care in a Dementia special care unit or program of a nursing home.</text> </paragraph> <paragraph num="(2)"> <text>The information disclosed shall explain the additional care provided in each of the following areas:</text> <paragraph num="(a)"> <text>The Dementia special care unit’s written statement of its overall philosophy and mission, which reflects the needs of residents with dementia;</text> </paragraph> <paragraph num="(b)"> <text>The process and criteria for placement, transfer, or discharge from the unit;</text> </paragraph> <paragraph num="(c)"> <text>The process used for individualized assessment and establishing the resident-centered plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in the individual’s condition;</text> </paragraph> <paragraph num="(d)"> <text>Staff training and continuing education practices;</text> </paragraph> <paragraph num="(e)"> <text>The physical environment and design features appropriate to support the functioning of cognitively impaired adult residents;</text> </paragraph> <paragraph num="(f)"> <text>The frequency and types of resident activities;</text> </paragraph> <paragraph num="(g)"> <text>The involvement of families and family support programs; and</text> </paragraph> <paragraph num="(h)"> <text>The cost of care and any additional fees.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Secured units shall meet the established standards applicable to nursing home set forth in NFPA 99 Health Care Facilities Code and NFPA 101 Life Safety Code.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Pharmaceutical Services."> <paragraph num="A."> <text>Definition. In this regulation, the term “committee” means the pharmaceutical services committee.</text> </paragraph> <paragraph num="B."> <text>Duties of the Nursing Home.</text> <paragraph num="(1)"> <text>The nursing home shall provide appropriate methods and procedures for administering drugs and biologicals to the nursing home’s residents.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall provide pharmaceutical services in accordance with accepted professional standards and related federal, State, and local laws.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Duties of the Pharmaceutical Services Committee.</text> <paragraph num="(1)"> <text>A pharmaceutical services committee, or its equivalent, shall develop written policies and procedures for safe and effective drug therapy, distribution, control, and use.</text> </paragraph> <paragraph num="(2)"> <text>The composition of the committee shall include at least:</text> <paragraph num="(a)"> <text>The licensed pharmacist;</text> </paragraph> <paragraph num="(b)"> <text>The director of nursing;</text> </paragraph> <paragraph num="(c)"> <text>The consultant dietitian-nutritionist;</text> </paragraph> <paragraph num="(d)"> <text>One physician; and</text> </paragraph> <paragraph num="(e)"> <text>The administrator.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The committee shall meet at least quarterly to establish policies and procedures.</text> </paragraph> <paragraph num="(4)"> <text>There shall be an agenda to guide meeting participants.</text> </paragraph> <paragraph num="(5)"> <text>All members of the committee shall review revisions of policies and procedures before implementing any changes.</text> </paragraph> <paragraph num="(6)"> <text>The pharmaceutical services committee may not develop policies and procedures that prohibit or restrict a resident from receiving medications from the pharmacy of the resident’s choice.</text> </paragraph> <paragraph num="(7)"> <text>In cases where the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the nursing home has contracted with to provide pharmaceutical services, the resident shall be responsible for the additional amount.</text> </paragraph> <paragraph num="(8)"> <text>The committee may not require the pharmacy to provide drugs by way of a specific drug distribution system such as unit dose or use of a particular packaging system.</text> </paragraph> <paragraph num="(9)"> <text>The committee shall establish the contents of sealed emergency drug kits.</text> </paragraph> <paragraph num="(10)"> <text>The committee shall oversee the accuracy and adequacy of pharmaceutical services to the nursing home.</text> </paragraph> <paragraph num="(11)"> <text>The committee shall make recommendations for improvements to pharmaceutical services.</text> </paragraph> <paragraph num="(12)"> <text>The committee shall document its actions and recommendations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Labeling.</text> <paragraph num="(1)"> <text>Medications shall be accurately and plainly labeled. Except for those over-the-counter medications that the Department may list as suitable for purchasing in bulk and dispensing as needed, the labels for all medications shall bear at least:</text> <paragraph num="(a)"> <text>The resident’s full name;</text> </paragraph> <paragraph num="(b)"> <text>The name of the drug;</text> </paragraph> <paragraph num="(c)"> <text>Strength;</text> </paragraph> <paragraph num="(d)"> <text>Original filling date and date refilled, if applicable;</text> </paragraph> <paragraph num="(e)"> <text>Name of authorized prescriber;</text> </paragraph> <paragraph num="(f)"> <text>Expiration date of medication (month, year);</text> </paragraph> <paragraph num="(g)"> <text>Any special handling and storage instructions;</text> </paragraph> <paragraph num="(h)"> <text>Name and address of dispensing pharmacy;</text> </paragraph> <paragraph num="(i)"> <text>Prescription number;</text> </paragraph> <paragraph num="(j)"> <text>Number of tablets or capsules; and</text> </paragraph> <paragraph num="(k)"> <text>Accessory federal labels.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A nurse may not package, repackage, bottle, or label any medication, in whole or in part, or alter any labeled medication in any way.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Storage.</text> <paragraph num="(1)"> <text>The nursing home shall store medications in a locked medication storage area that:</text> <paragraph num="(a)"> <text>Is well lighted;</text> </paragraph> <paragraph num="(b)"> <text>Is located where personnel preparing drugs for administration will not be interrupted;</text> </paragraph> <paragraph num="(c)"> <text>Is spacious enough to allow separate storage of external and internal medications;</text> </paragraph> <paragraph num="(d)"> <text>Is kept in a clean, orderly and uncluttered manner; and</text> </paragraph> <paragraph num="(e)"> <text>Contains a refrigerator to be used for medication storage only.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nursing home shall keep poisons and medications marked “for external use only” separate from general medications and Schedule II drugs.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Schedule II—IV Drugs.</text> <paragraph num="(1)"> <text>Schedule II drugs shall be kept in separately locked, securely fixed boxes or drawers in the storage area, under two locks. The lock on the door of a medication room shall be counted as one of the two locks.</text> </paragraph> <paragraph num="(2)"> <text>A nurse and a second staff member who is a nurse or an administrator may destroy controlled dangerous substances in Schedules II—V on the premises of the nursing home.</text> </paragraph> <paragraph num="(3)"> <text>If a controlled dangerous substance is destroyed on the nursing home premises in accordance with §F(2) of this regulation:</text> <paragraph num="(a)"> <text>A record of the disposal, in addition to any other required records, shall be maintained in the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>A copy of the record of disposal shall be forwarded to the Office of Controlled Substances Administration.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A nursing home, whether or not operating a licensed pharmacy, shall maintain a signed record of a Schedule II count at each change of shift.</text> </paragraph> <paragraph num="(5)"> <text>A nursing home that administers Schedule II drugs shall maintain a drug record that documents:</text> <paragraph num="(a)"> <text>The name of the resident;</text> </paragraph> <paragraph num="(b)"> <text>The date, time, kind, dosage, and method of administration of all Schedule II drugs; and</text> </paragraph> <paragraph num="(c)"> <text>The name of the authorized prescriber who prescribed the medication.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Pharmaceutical Management."> <paragraph num="A."> <text>Administration Procedures.</text> <paragraph num="(1)"> <text>Medications, legend and non-legend, administered to residents shall be ordered in writing by the resident’s physician.</text> </paragraph> <paragraph num="(2)"> <text>Medications shall be administered by:</text> <paragraph num="(a)"> <text>Appropriately licensed personnel in accordance with laws and regulations governing these acts; or</text> </paragraph> <paragraph num="(b)"> <text>Certified graduates of a State-approved medicine aide course.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The individual who prepares medications shall give and record them.</text> </paragraph> <paragraph num="(4)"> <text>Medicine may not be returned to the container. If the resident refuses the drug or if a mistake occurs:</text> <paragraph num="(a)"> <text>The drug shall be discarded; and</text> </paragraph> <paragraph num="(b)"> <text>The occurrence shall be documented in the resident’s chart.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Before invoking stop order policies, the resident’s attending physician shall be contacted for instructions so that continuity of the resident’s therapeutic regimen is not interrupted. If the attending physician cannot be reached, the medical director shall be contacted for instructions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pharmaceutical Services.</text> <paragraph num="(1)"> <text>The nursing home shall arrange for pharmacies that provide medications for residents in the nursing home. The pharmacy shall agree in writing to maintain at the pharmacy a resident profile record system for each resident in the nursing home for whom prescriptions are dispensed.</text> </paragraph> <paragraph num="(2)"> <text>If the nursing home does not employ a licensed pharmacist, the nursing home shall arrange by written contract for a pharmacy to provide consultation on administering the pharmacy services in accordance with the policies and procedures established by the pharmaceutical services committee. Pharmaceutical services shall be under the general supervision of a licensed pharmacist who shall:</text> <paragraph num="(a)"> <text>With the advice of the pharmaceutical services committee, be responsible for developing, coordinating, and supervising pharmaceutical services and provide in-service training at least twice yearly;</text> </paragraph> <paragraph num="(b)"> <text>Visit the nursing home frequently enough to ensure that policies and procedures established by the pharmaceutical services committee are enforced;</text> </paragraph> <paragraph num="(c)"> <text>Notify the attending physician of any potential drug problems found during the drug regimen review; and</text> </paragraph> <paragraph num="(d)"> <text>At least quarterly, submit a report to the pharmaceutical services committee on the status of the nursing home’s pharmaceutical services and staff adherence to policies and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Resident-Designated Pharmacy.</text> <paragraph num="(1)"> <text>The nursing home shall inform a resident’s designated pharmacy about the nursing home’s written policies concerning the provision of drugs.</text> </paragraph> <paragraph num="(2)"> <text>To provide services to the resident, a designated pharmacy shall agree to comply with the nursing home’s policies.</text> </paragraph> <paragraph num="(3)"> <text>If the pharmacy fails to comply with the policies, a representative of the nursing home shall discuss the situation with the pharmacy and the resident, and if the pharmacy subsequently refuses to follow the policies, the resident shall select another pharmacy that agrees to comply.</text> </paragraph> <paragraph num="(4)"> <text>The pharmacy shall have access to a copy of the written pharmaceutical care policies.</text> </paragraph> <paragraph num="(5)"> <text>The pharmacy shall be responsible for delivering medications to the nursing home. Members of the resident’s family or the responsible party for the resident may not deliver medications to the resident or to the nursing home.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Medication Return and Disposal.</text> <paragraph num="(1)"> <text>The nursing home shall return all prescribed medications, for residents who have been discharged or otherwise departed, to the pharmacy in accordance with the nursing home’s policy.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall destroy adulterated, deteriorated, or outdated medications in the following manner:</text> <paragraph num="(a)"> <text>Disposal shall occur in the presence of two witnesses who are authorized by the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>The witnesses shall document the disposal in the resident’s chart.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The nursing home shall only release prescribed medications to residents at the time of discharge based on the written authorization of the resident’s authorized prescriber.</text> </paragraph> <paragraph num="(4)"> <text>Each month, the nursing home shall perform a drug regimen review on each resident’s records at the nursing home and document the findings in the resident’s medical record.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Administration of Medications for Leave of Absence of 24 Hours or Less.</text> <paragraph num="(1)"> <text>A nursing home shall develop policies and procedures to ensure that a resident or, if the resident lacks the capacity, the resident’s family or other individual accompanying the resident is informed, both orally and in writing, on how the resident shall safely and correctly take the resident’s medications during a short-term leave of absence of 24 hours or less.</text> </paragraph> <paragraph num="(2)"> <text>In accordance with a nursing home-developed procedure, a licensed nurse shall prepare medications to be sent with a resident during a short-term leave of absence of 24 hours or less.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Laboratory and Radiologic Services."> <paragraph num="A."> <text>Approved Source. Laboratory services provided by the facility shall meet the applicable conditions established under COMAR 10.10.01 Medical Laboratories in Maryland.</text> </paragraph> <paragraph num="B."> <text>Provisions of Services. If the facility does not provide laboratory and radiologic services, arrangements shall be made for obtaining these services from a physician's office, a licensed laboratory in a hospital or nursing facility, a licensed independent laboratory, or a State-approved portable X-ray supplier.</text> </paragraph> <paragraph num="C."> <text>Physician's Order Required. All services shall be provided only on the orders of the attending physician.</text> </paragraph> <paragraph num="D."> <text>Reports of Findings. The nursing home shall notify the attending physician promptly of the findings. The nursing home shall file signed and dated reports of diagnostic services in the resident’s medical record.</text> </paragraph> <paragraph num="E."> <text>Transportation. The nursing home shall assist the resident, if necessary, in arranging transportation to and from the source of service.</text> </paragraph> <paragraph num="F."> <text>Blood and Blood Products — Blood Handling and Storage. Blood handling and storage facilities shall be safe, adequate, and properly supervised.</text> </paragraph> <paragraph num="G."> <text>Storage and Transfusion. If the facility provides for maintaining and transfusing blood and blood products, it shall meet the standards in COMAR 10.10.02 Blood Banks.</text> </paragraph> <paragraph num="H."> <text>Transfusion Services. If the nursing home only provides transfusion services, it shall meet at least the requirements established under COMAR 10.10.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Dental Services."> <paragraph num="A."> <text>Provision for Dental Care. Residents shall be assisted to obtain routine and emergency dental care.</text> </paragraph> <paragraph num="B."> <text>Advisory Dentist. There shall be an advisory dentist who shall:</text> <paragraph num="(1)"> <text>Recommend oral hygiene policies and practices for the care of the residents and for arrangements for emergency treatment;</text> </paragraph> <paragraph num="(2)"> <text>Assist in the formulation of dental health policies;</text> </paragraph> <paragraph num="(3)"> <text>Provide direction for in-service training to give the nursing staff an understanding of residents’ dental problems.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Assistance by Nursing Personnel. Nursing personnel shall assist the resident in carrying out routine dental hygiene.</text> </paragraph> <paragraph num="D."> <text>Arrangements for Dental Service. If dental services are not provided on the premises, there shall be a cooperative agreement with a dental service.</text> </paragraph> <paragraph num="E."> <text>Transportation. Arrangements shall be made, when necessary, for the resident to be transported to the dentist’s office.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Social Work Services."> <paragraph num="A."> <text>Services Provided. The nursing home shall provide or make arrangements for services to identify and meet the resident’s medically related physical, social, and behavioral health needs.</text> </paragraph> <paragraph num="B."> <text>Social Work Staff Responsibility.</text> <paragraph num="(1)"> <text>Social services responsibilities in the nursing home shall be assigned to a:</text> <paragraph num="(a)"> <text>Licensed bachelor social worker;</text> </paragraph> <paragraph num="(b)"> <text>Licensed graduate social worker;</text> </paragraph> <paragraph num="(c)"> <text>Licensed certified social worker; or</text> </paragraph> <paragraph num="(d)"> <text>Licensed certified social worker–clinical.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the social worker is not a licensed certified social worker (LCSW) or a licensed certified social worker-clinical (LCSW-C), the nursing home shall arrange for an LCSW or LCSW-C to provide sufficient hours of supervision.</text> </paragraph> <paragraph num="(3)"> <text>As of January 1, 2021, a license is required for an employee to provide social services except if:</text> <paragraph num="(a)"> <text>On the effective date of these regulations, the employee was assigned responsibility for social services; and</text> </paragraph> <paragraph num="(b)"> <text>The nursing home has an agreement with a qualified social work consultant that provides for sufficient hours of supervision to assure that the employee’s services meet the medically related physical, social, and behavioral health needs of the residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Social History. Within 7 days after admission, the social worker shall initiate a written social history, which shall be as complete as possible and shall include:</text> <paragraph num="(1)"> <text>Social data about personal and family background to provide understanding of the resident and how the resident functions;</text> </paragraph> <paragraph num="(2)"> <text>Information regarding current personal and family circumstances and attitudes as they relate to the resident’s illness and care; and</text> </paragraph> <paragraph num="(3)"> <text>Information regarding the resident’s and family’s plans regarding discharge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Records. Records shall include the information required in §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>Space. A nursing home shall provide:</text> <paragraph num="(1)"> <text>Space for social work personnel, accessible to residents, medical, and other staff; and</text> </paragraph> <paragraph num="(2)"> <text>Privacy for interviews.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Resident Activities."> <paragraph num="A."> <text>Activities Program. The nursing home shall provide:</text> <paragraph num="(1)"> <text>A program of structured and unstructured activities; and</text> </paragraph> <paragraph num="(2)"> <text>Activities designed and monitored appropriately to meet the day-to-day needs and interests of each resident and encourage:</text> <paragraph num="(a)"> <text>Self-care;</text> </paragraph> <paragraph num="(b)"> <text>Engagement in resident-selected activities; and</text> </paragraph> <paragraph num="(c)"> <text>Maintenance of an optimal level of psychosocial functioning.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Staffing. A staff member who is qualified by experience or training shall be appointed to be responsible for the activities program. If the designee is not a qualified resident activities coordinator as defined in Regulation .01 of this chapter, the Department may approve the designee based on the person’s education, performance, and experience.</text> </paragraph> <paragraph num="C."> <text>If the Department determines that an effective program is not maintained consultation may be required as specified by the Department.</text> </paragraph> <paragraph num="D."> <text>Restrictions on Participation Documented on Chart. The physician shall document in the resident’s chart any restrictions applicable to the resident’s participation in the activities program.</text> </paragraph> <paragraph num="E."> <text>Objective. The activities shall be designed to promote the general health and physical, social, and mental well-being of the residents.</text> </paragraph> <paragraph num="F."> <text>Space, Supplies. The nursing home shall provide adequate space and a variety of supplies and equipment to satisfy the appropriate individual activity needs of residents.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Clinical Records."> <paragraph num="A."> <text>Records for all Residents. Records for all residents shall be maintained in accordance with accepted professional standards and practices.</text> </paragraph> <paragraph num="B."> <text>Contents of Record. Contents of record shall include:</text> <paragraph num="(1)"> <text>Identification and summary sheet or sheets including:</text> <paragraph num="(a)"> <text>Resident’s name;</text> </paragraph> <paragraph num="(b)"> <text>Social Security number;</text> </paragraph> <paragraph num="(c)"> <text>Armed forces status;</text> </paragraph> <paragraph num="(d)"> <text>Citizenship;</text> </paragraph> <paragraph num="(e)"> <text>Marital status;</text> </paragraph> <paragraph num="(f)"> <text>Age;</text> </paragraph> <paragraph num="(g)"> <text>Sex;</text> </paragraph> <paragraph num="(h)"> <text>Home address; and</text> </paragraph> <paragraph num="(i)"> <text>Religion;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Names, addresses, and telephone numbers of referral agencies, including:</text> <paragraph num="(a)"> <text>Hospital from which admitted;</text> </paragraph> <paragraph num="(b)"> <text>Personal physician;</text> </paragraph> <paragraph num="(c)"> <text>Dentist;</text> </paragraph> <paragraph num="(d)"> <text>Parents’ names or next of kin; and</text> </paragraph> <paragraph num="(e)"> <text>Resident’s representative;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation of the:</text> <paragraph num="(a)"> <text>Needs of the resident;</text> </paragraph> <paragraph num="(b)"> <text>Establishment of an appropriate initial and ongoing treatment plan; and</text> </paragraph> <paragraph num="(c)"> <text>Care and services provided;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Authentication of hospital diagnoses, based on a:</text> <paragraph num="(a)"> <text>Discharge summary;</text> </paragraph> <paragraph num="(b)"> <text>Report from the resident’s attending physician; or</text> </paragraph> <paragraph num="(c)"> <text>Transfer form;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Consent forms when required, such as:</text> <paragraph num="(a)"> <text>Administration of investigational drugs;</text> </paragraph> <paragraph num="(b)"> <text>Burial arrangements made in advance;</text> </paragraph> <paragraph num="(c)"> <text>Release of medical record information; and</text> </paragraph> <paragraph num="(d)"> <text>Handling of finances;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Medical and social history of the resident;</text> </paragraph> <paragraph num="(7)"> <text>Report of physical examination;</text> </paragraph> <paragraph num="(8)"> <text>Diagnostic and therapeutic orders;</text> </paragraph> <paragraph num="(9)"> <text>Consultation reports;</text> </paragraph> <paragraph num="(10)"> <text>Observations and progress notes;</text> </paragraph> <paragraph num="(11)"> <text>Reports of medication administration, treatments, and clinical findings;</text> </paragraph> <paragraph num="(12)"> <text>Discharge summary including final diagnosis and prognosis;</text> </paragraph> <paragraph num="(13)"> <text>Assessments done by various disciplines; and</text> </paragraph> <paragraph num="(14)"> <text>Interdisciplinary care plan.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing. An employee of the nursing home shall be designated as the person responsible for the overall supervision of the medical records service. There shall be sufficient support staff to accomplish all medical records functions.</text> </paragraph> <paragraph num="D."> <text>Consultation. If the medical records supervisor is not a qualified medical record practitioner, the Department may require that the supervisor receive consultation from a qualified person.</text> </paragraph> <paragraph num="E."> <text>Completion of Records and Centralization of Reports.</text> <paragraph num="(1)"> <text>Current medical records and those of discharged residents shall be completed promptly.</text> </paragraph> <paragraph num="(2)"> <text>All clinical information pertaining to a resident’s stay shall be centralized in the resident’s medical record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Retention and Preservation of Records.</text> <paragraph num="(1)"> <text>Medical records shall be retained for a period of at least 5 years from the date of discharge or, in the case of a minor, 3 years after the resident becomes of age or 5 years, whichever is longer.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitles 3 and 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Current Records — Location and Facilities. The nursing home shall maintain adequate space and equipment, conveniently located, to provide for efficient processing, reviewing, indexing, filing, and prompt retrieval of medical records.</text> </paragraph> <paragraph num="H."> <text>Closed or Inactive Records. Closed or inactive records shall be filed and stored in a safe place, free from fire hazards, which provides for confidentiality and, when necessary, retrieval.</text> </paragraph> <paragraph num="I."> <text>Electronic Health Records.</text> <paragraph num="(1)"> <text>A nursing home that uses electronic health records exclusively or along with a paper-based medical record shall comply with this chapter and all applicable State and federal laws, including laws governing privacy and security of records.</text> </paragraph> <paragraph num="(2)"> <text>Staff and nursing home-approved practitioners shall be trained in the use of electronic health records.</text> </paragraph> <paragraph num="(3)"> <text>A nursing home that uses electronic health records shall:</text> <paragraph num="(a)"> <text>Ensure access to residents as specified in COMAR 10.07.09.08C(13) and (14); and</text> </paragraph> <paragraph num="(b)"> <text>On request, provide the resident with copies of the resident’s medical records at a reasonable cost and in the resident’s preferred format.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A nursing home shall provide full access to electronic health records in accordance with all applicable laws and regulations to:</text> <paragraph num="(a)"> <text>Representatives of the Department as set forth in COMAR 10.07.02.07;</text> </paragraph> <paragraph num="(b)"> <text>An ombudsman as set forth in Human Services Article, §10-905, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Other legal representatives as set forth in COMAR 10.07.09.08 and authorized by law to obtain access.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A nursing home shall develop a system to ensure that nursing home staff have access to residents’ health records in the event of a failure of the nursing home’s electronic medical record system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Infection Prevention and Control Program."> <paragraph num="A."> <text>Infection Prevention and Control Program. The nursing home shall establish, implement, and maintain an effective infection prevention and control program that:</text> <paragraph num="(1)"> <text>Investigates, controls, and prevents infections in a timely manner through a system that enables the facility to:</text> <paragraph num="(a)"> <text>Analyze patterns of infected individuals;</text> </paragraph> <paragraph num="(b)"> <text>Analyze changes in prevalent organisms;</text> </paragraph> <paragraph num="(c)"> <text>Analyze increases in the rate of infection; and</text> </paragraph> <paragraph num="(d)"> <text>Obtain surveillance data for the prevention and control of additional cases;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Determines the procedures, such as appropriate precautions, that are to be applied to an individual resident;</text> </paragraph> <paragraph num="(3)"> <text>Maintains a record of infections in the nursing home and the corrective actions that were taken related to infections; and</text> </paragraph> <paragraph num="(4)"> <text>Monitors and evaluates the:</text> <paragraph num="(a)"> <text>Effectiveness of the infection prevention and control program by surveying rates of infection, especially infection rates that are significantly higher than usual; and</text> </paragraph> <paragraph num="(b)"> <text>Effective implementation of the policies and procedures that are outlined in §E(1) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Infection Preventionist.</text> <paragraph num="(1)"> <text>The nursing home shall assign at least one infection preventionist that has attended training in infection surveillance, prevention, and control to actively manage the nursing home’s infection prevention and control program.</text> </paragraph> <paragraph num="(2)"> <text>The infection preventionist shall attend or have attended a basic infection prevention and control training course that is approved by the:</text> <paragraph num="(a)"> <text>Office of Health Care Quality; and</text> </paragraph> <paragraph num="(b)"> <text>Office of Infectious Disease Epidemiology and Outbreak Response for the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>This position shall be staffed at a ratio of 1.0 Full Time Equivalents for every 200 beds.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The nursing home shall have mechanisms for communicating the results of infection control activities to employees and to the individual or individuals who are responsible for improving the nursing home’s performance.</text> </paragraph> <paragraph num="D."> <text>The nursing home’s communication mechanism shall ensure that the administrator, director of nursing, and the medical director receive and address reports of infection prevention and control findings and recommendations in a timely manner.</text> </paragraph> <paragraph num="E."> <text>Infection Prevention and Control Policies and Procedures.</text> <paragraph num="(1)"> <text>The infection prevention and control program shall establish written policies and procedures to identify, investigate, control, and prevent infections in the nursing home, including policies and procedures to:</text> <paragraph num="(a)"> <text>Identify health care-associated infections and communicable diseases in accordance with COMAR 10.06.01;</text> </paragraph> <paragraph num="(b)"> <text>Report occurrences of certain infectious diseases and outbreaks of infectious diseases to the local health department in a timely manner in accordance with COMAR 10.06.01 and Health-General Article, §18-202, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Institute appropriate control measures when an infection or outbreak of infections is suspected or identified in order to control infection and prevent spread to other residents;</text> </paragraph> <paragraph num="(d)"> <text>Perform surveillance for health care-associated and community-associated infections of residents and employees using definitions and methods approved by the infection prevention and control oversight committee to monitor and investigate causes of infection, and the manner in which the infection is spread;</text> </paragraph> <paragraph num="(e)"> <text>Train employees about infection prevention and control, including:</text> <paragraph num="(i)"> <text>Standard precautions and hand hygiene;</text> </paragraph> <paragraph num="(ii)"> <text>Respiratory hygiene and cough etiquette;</text> </paragraph> <paragraph num="(iii)"> <text>Soiled laundry and linen processing;</text> </paragraph> <paragraph num="(iv)"> <text>Safe handling of needles and sharps and safe injection techniques;</text> </paragraph> <paragraph num="(v)"> <text>Special medical waste handling and disposal;</text> </paragraph> <paragraph num="(vi)"> <text>Appropriate use of antiseptics and disinfectants;</text> </paragraph> <paragraph num="(vii)"> <text>Blood-borne pathogens, including hepatitis B and C and human immunodeficiency virus;</text> </paragraph> <paragraph num="(viii)"> <text>Tuberculosis exposure; and</text> </paragraph> <paragraph num="(ix)"> <text>Proper use and wearing of personal protective equipment, such as gloves, gowns, and eye protection;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Train and perform compliance monitoring of employee application of infection prevention and control activities, such as hand hygiene and personal protective equipment used for isolation precautions;</text> </paragraph> <paragraph num="(g)"> <text>Review the infection prevention and control program elements at least annually and revise as necessary; and</text> </paragraph> <paragraph num="(h)"> <text>Obtain annual approval of infection prevention and control program activities by the infection prevention and control oversight committee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nursing home shall provide information concerning the infectious disease status of any resident being transferred or discharged to any other nursing home, including a funeral home.</text> </paragraph> <paragraph num="(3)"> <text>The nursing home shall obtain information concerning the infectious disease status of any resident being transferred or admitted to the nursing home from elsewhere.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Preventing Spread of Infection.</text> <paragraph num="(1)"> <text>The facility shall assess any residents with signs and symptoms of an infectious illness for the possibility of transmission to another resident or employee.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall take appropriate infection prevention and control measures to prevent the transmission of an infectious disease to residents, employees, and visitors as outlined in the following guidelines:</text> <paragraph num="(a)"> <text>2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and</text> </paragraph> <paragraph num="(b)"> <text>Guideline for Infection Control in Health Care Personnel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The nursing home shall prohibit employees with an infectious disease or with infected skin lesions from having direct contact with residents or their food if direct contact could transmit the disease.</text> </paragraph> <paragraph num="(4)"> <text>The nursing home shall require employees to perform hand hygiene before and after each direct resident contact for which hand hygiene is indicated by accepted professional practice.</text> </paragraph> <paragraph num="(5)"> <text>The facility shall handle, store, process, and transport linens so as to prevent the spread of infection.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Employee Health Program."> <paragraph num="A."> <text>The nursing home’s infection prevention and control program shall monitor the relevant health status of all employees, as it relates to infection prevention and control. The nursing home shall refer to the following guidelines in implementing its employee health program:</text> <paragraph num="(1)"> <text>Guideline for Infection Control in Health Care Personnel;</text> </paragraph> <paragraph num="(2)"> <text>Immunization of Health Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC); and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 09.12.31.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Tuberculosis Exposure Control.</text> <paragraph num="(1)"> <text>The infection control program shall include a risk assessment program, including monitoring for tuberculosis infection for employees that is in accordance with the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall ensure that employees may not provide services that require direct access to residents without documented evidence that the employee is free from communicable tuberculosis.</text> </paragraph> <paragraph num="(3)"> <text>A new employee shall be assessed for risk of tuberculosis through:</text> <paragraph num="(a)"> <text>A two-step tuberculin skin testing at the time of hire following guidelines referenced in the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings; or</text> </paragraph> <paragraph num="(b)"> <text>An interferon-gamma release assay (IGRA) blood test.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The nursing home shall maintain written documentation of the following:</text> <paragraph num="(a)"> <text>Results of tuberculin skin tests, recorded in millimeters of induration with dates of administration, dates of reading, results of test, and the manufacturer and lot number of the purified protein derivative (PPD) solution used; and</text> </paragraph> <paragraph num="(b)"> <text>Any previous tuberculin skin tests, chest x-ray, or blood test results, chemotherapy, and chemoprophylaxis that are the basis for certifying that the individual is free from tuberculosis in a communicable form.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Measles, Mumps, Rubella, and Varicella.</text> <paragraph num="(1)"> <text>The nursing home shall screen and maintain written documentation of each employee’s proof of immunity to common childhood infections including measles, mumps, rubella, and chickenpox (varicella). Proof of immunity to these diseases shall be verified by:</text> <paragraph num="(a)"> <text>Documented evidence of administration of vaccine; or</text> </paragraph> <paragraph num="(b)"> <text>Laboratory evidence of immunity.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nursing home shall require that employees who are not immune to measles, mumps, rubella, and varicella receive immunization for measles, mumps, rubella, or varicella, unless medically contraindicated or against the employee’s religious beliefs. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for it.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Hepatitis B. The nursing home shall require that all new employees receive immunization for Hepatitis B, unless medically contraindicated, against the employee’s religious beliefs, or after being fully informed of the health risks of not being immunized. The nursing home shall inform all new and current employees of the health risks of not being immunized. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal.</text> </paragraph> <paragraph num="E."> <text>Influenza.</text> <paragraph num="(1)"> <text>The nursing home shall require that all employees receive annual immunization for influenza, unless:</text> <paragraph num="(a)"> <text>Medically contraindicated;</text> </paragraph> <paragraph num="(b)"> <text>Against the employee’s religious beliefs; or</text> </paragraph> <paragraph num="(c)"> <text>After being fully informed of the health risks associated with not receiving a vaccine, the employee refuses the immunization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nursing home shall:</text> <paragraph num="(a)"> <text>Comply with Health-General Article, §18-404, Annotated Code of Maryland, regarding immunizations of employees;</text> </paragraph> <paragraph num="(b)"> <text>Inform all new and current employees of the health risks of not being immunized;</text> </paragraph> <paragraph num="(c)"> <text>Document refusals; and</text> </paragraph> <paragraph num="(d)"> <text>Require that any employee who is not vaccinated with the current influenza vaccine wear a mask when:</text> <paragraph num="(i)"> <text>Within 6 feet of a resident; and</text> </paragraph> <paragraph num="(ii)"> <text>During the influenza season as specified by the State’s Prevention and Health Promotion Administration, based on influenza activity in Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Pertussis. The nursing home shall:</text> <paragraph num="(1)"> <text>Require that each new employee receive a one-dose booster immunization for pertussis, unless medically contraindicated or against the employee’s religious beliefs;</text> </paragraph> <paragraph num="(2)"> <text>Inform all new and current employees of the health risks of not being immunized;</text> </paragraph> <paragraph num="(3)"> <text>Document any refusals of immunization; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the immunization is given in the form of Tdap (tetanus, diphtheria, acellular pertussis) vaccine, in accordance with the guidelines prescribed in Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Health Care Infection Control Practices Advisory Committee (HICPAC).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Resident Health Program."> <paragraph num="A."> <text>Immunization.</text> <paragraph num="(1)"> <text>The nursing home shall offer influenza and pneumococcal immunization to each resident.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall obtain written consent to administer the immunization from:</text> <paragraph num="(a)"> <text>The resident; or</text> </paragraph> <paragraph num="(b)"> <text>The resident's representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A resident is not required to receive the influenza and pneumococcal immunization if it is:</text> <paragraph num="(a)"> <text>Medically contraindicated;</text> </paragraph> <paragraph num="(b)"> <text>Against the resident’s religious beliefs; or</text> </paragraph> <paragraph num="(c)"> <text>After being fully informed of the health risks associated with not receiving a vaccine, the resident refuses the immunization.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the resident refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal.</text> </paragraph> <paragraph num="(5)"> <text>The nursing home shall notify each prospective resident of the immunization requirements and request that the resident agree to be immunized.</text> </paragraph> <paragraph num="(6)"> <text>The nursing home shall make available to residents educational and informational materials relating to immunization against influenza virus and immunization against pneumococcal disease.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Tuberculosis Assessment.</text> <paragraph num="(1)"> <text>The nursing home shall assess residents for tuberculosis according to the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care Settings.</text> </paragraph> <paragraph num="(2)"> <text>A new resident shall receive a two-step tuberculin skin test within 10 days of admission to the nursing home unless the resident has had:</text> <paragraph num="(a)"> <text>A documented negative tuberculin skin test within the previous 12 months;</text> </paragraph> <paragraph num="(b)"> <text>A previous positive tuberculin skin test;</text> </paragraph> <paragraph num="(c)"> <text>A history of preventive therapy treatment;</text> </paragraph> <paragraph num="(d)"> <text>A latent infection; or</text> </paragraph> <paragraph num="(e)"> <text>The treatment of active tuberculosis.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The nursing home shall continue to monitor residents for signs and symptoms of tuberculosis by performing a yearly symptom review. When a resident has signs and symptoms of tuberculosis, a physician shall be notified to:</text> <paragraph num="(a)"> <text>Evaluate the resident for possible tuberculosis in a communicable form;</text> </paragraph> <paragraph num="(b)"> <text>Notify the health officer within 24 hours if the physician suspects tuberculosis; and</text> </paragraph> <paragraph num="(c)"> <text>Coordinate management of the resident and the resident’s contacts with the local health officer.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The nursing home shall assess and manage a resident with a history of a previous positive tuberculin skin test, a history of latent infection, or a previous history of active tuberculosis, in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Volunteer Health Program."> <paragraph num="A."> <text>The nursing home shall urge that volunteers, defined as individuals who spend an average of 8 hours per week or more in the resident care areas and who receive no pay or benefits, receive annual influenza vaccination and tuberculin skin testing as considered necessary by the nursing home.</text> </paragraph> <paragraph num="B."> <text>The nursing home shall give appropriate health care information to such volunteers to provide maximum protection to residents.</text> </paragraph> <paragraph num="C."> <text>The nursing home shall maintain documentation of the discussion between the nursing home and the volunteer concerning influenza vaccine and tuberculin skin testing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Infection Control — Standard Precautions."> <paragraph num="A."> <text>Standard Precautions. All employees shall routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or the body fluids of any resident is anticipated as outlined in:</text> <paragraph num="(1)"> <text>2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and</text> </paragraph> <paragraph num="(2)"> <text>COMAR 09.12.31.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The infection prevention and control program shall include the handling of special medical waste as defined in COMAR 10.06.06.</text> </paragraph> <paragraph num="C."> <text>A nursing home shall maintain, at all times, the capability to physically isolate any resident who may contract a communicable disease from the remaining resident population. To provide for this, a nursing home shall have at least one private bedroom with an attached private bathroom that includes a:</text> <paragraph num="(1)"> <text>Toilet;</text> </paragraph> <paragraph num="(2)"> <text>Hand-washing sink; and</text> </paragraph> <paragraph num="(3)"> <text>Bathtub, shower, or other bathing device.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Reports and Action Required in Unusual Circumstances."> <paragraph num="A."> <text>Serious Emotional Disturbances. A facility may not accept or keep patients who destroy property or are dangerous to themselves or others, or who have acute symptoms of mental illness.</text> </paragraph> <paragraph num="B."> <text>Action to Be Taken if a Patient Becomes Actively Disturbed. The following action shall be taken:</text> <paragraph num="(1)"> <text>If a patient becomes actively disturbed, the personal physician shall be notified immediately.</text> </paragraph> <paragraph num="(2)"> <text>A restraint may be used only if all of the following conditions are met:</text> <paragraph num="(a)"> <text>Failure to use a restraint or restraints is likely to endanger the health or safety of the patient or others;</text> </paragraph> <paragraph num="(b)"> <text>There is a written physician's order for the use of the restraint or restraints, which shall comply with the following requirements:</text> <paragraph num="(i)"> <text>The physician's written order for the restraint or restraints shall be for a specified maximum period of time, not to exceed 24 hours.</text> </paragraph> <paragraph num="(ii)"> <text>The necessity for the use of the restraint or restraints shall be documented, and</text> </paragraph> <paragraph num="(iii)"> <text>The frequency of patient observations by licensed personnel on not less than an hourly basis during the period of time that the restraint or restraints or the effects of the restraint or restraints are present shall be indicated;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Appropriate documentation by licensed personnel shall be recorded in the clinical record;</text> </paragraph> <paragraph num="(d)"> <text>The facility may not re-impose a restraint or restraints except upon the written order of a physician who has personally observed the patient since the previous restraint or restraints order was imposed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A restraint or restraints may not be ordered PRN.</text> </paragraph> <paragraph num="(4)"> <text>If a physician is not immediately available, a registered nurse may authorize the use of a physical restraint or restraints for a period not to exceed 4 hours in any 30-day period. Licensed personnel shall observe the patient hourly. The patient shall be seen by a physician if the restraint or restraints are to be applied for more than the initial 4-hour period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unusual Occurrences.</text> <paragraph num="(1)"> <text>The administrator of the nursing home shall immediately report to the local health department and the Department the occurrence of:</text> <paragraph num="(a)"> <text>Infectious disease;</text> </paragraph> <paragraph num="(b)"> <text>Poisoning;</text> </paragraph> <paragraph num="(c)"> <text>Internal emergency or disaster;</text> </paragraph> <paragraph num="(d)"> <text>External emergency or disaster,</text> </paragraph> <paragraph num="(e)"> <text>Any symptomatic condition of importance to public health that affects the nursing home; or</text> </paragraph> <paragraph num="(f)"> <text>Any other serious occurrence that threatens the welfare, safety, or health of any resident.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The administrator of the nursing home shall be responsible for ensuring that appropriate procedures and reporting are carried out for all reportable infections. An occurrence of a confirmed or suspected infection shall be reported and acted on in accordance with COMAR 10.06.01 and COMAR 10.15.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Transfer Agreement."> <paragraph num="A."> <text>Written Agreement. A written agreement with at least one acute hospital shall be effected which shall provide for the following actions:</text> <paragraph num="(1)"> <text>Planning to ensure that all services required for the continuity of resident care will be made available promptly;</text> </paragraph> <paragraph num="(2)"> <text>Advance discussion with the resident regarding the reason for the transfer and any available alternatives;</text> </paragraph> <paragraph num="(3)"> <text>Notification to the next of kin or responsible person regarding the anticipated transfer;</text> </paragraph> <paragraph num="(4)"> <text>Interchange of medical and other information necessary in the care and treatment of residents transferred between facilities, including notification of the licensed pharmacist of resident transfer;</text> </paragraph> <paragraph num="(5)"> <text>Safe and timely transportation and care of the resident during transfer;</text> </paragraph> <paragraph num="(6)"> <text>Security and accountability for the resident’s personal effects;</text> </paragraph> <paragraph num="(7)"> <text>Prompt readmission to the nursing home at the end of the hospital stay;</text> </paragraph> <paragraph num="(8)"> <text>Annual review of transfer arrangements by a utilization review committee or other designated group to ensure that each party is fulfilling the needs of the residents, the providers, the hospital, and the nursing home;</text> </paragraph> <paragraph num="(9)"> <text>If needs are not being met, the administrator of the nursing home shall act on recommendations of the reviewing group to effect compliance;</text> </paragraph> <paragraph num="(10)"> <text>Before licensure, the comprehensive care facility or the extended care facility shall submit to the Department a copy of the written agreement, signed by persons authorized to execute the agreement on behalf of the facilities;</text> </paragraph> <paragraph num="(11)"> <text>Each facility shall maintain a signed copy of the agreement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Facilities Under Common Control. If two facilities are under common control, a written agreement is not required; policies and procedures of both facilities shall provide assurance that §A(1)—(12) will be the practice of the facilities.</text> </paragraph> <paragraph num="C."> <text>Human remains shall be transported pursuant to COMAR 10.29.21.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Emergency and Disaster Plan."> <paragraph num="A."> <text>Emergency and Disaster Plan.</text> <paragraph num="(1)"> <text>The licensee shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including:</text> <paragraph num="(a)"> <text>Evacuation, transportation, or shelter in place of residents;</text> </paragraph> <paragraph num="(b)"> <text>Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents;</text> </paragraph> <paragraph num="(c)"> <text>Staff coverage, organization, and assignment of responsibilities for ongoing shelter in place or evacuation, including identification of staff members available to report to work or remain for extended periods; and</text> </paragraph> <paragraph num="(d)"> <text>The continuity of services, including:</text> <paragraph num="(i)"> <text>Operations, planning, and financial and logistical arrangements;</text> </paragraph> <paragraph num="(ii)"> <text>Procuring essential goods, equipment, and services to sustain operations for at least 72 hours;</text> </paragraph> <paragraph num="(iii)"> <text>Relocation to alternate facilities or other locations; and</text> </paragraph> <paragraph num="(iv)"> <text>Reasonable efforts to continue care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee shall have a tracking system to locate and identify residents in the event of displacement due to an emergency or disaster that includes at a minimum the:</text> <paragraph num="(a)"> <text>Resident's name;</text> </paragraph> <paragraph num="(b)"> <text>Time that the resident was sent to the initial alternative facility or location; and</text> </paragraph> <paragraph num="(c)"> <text>Name of the initial alternative facility or location where the resident was sent.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the nursing home relocates residents, the nursing home shall send a medical fact sheet and any medically related information with each resident that includes at a minimum the resident’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Medical condition or diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Medications;</text> </paragraph> <paragraph num="(d)"> <text>Allergies;</text> </paragraph> <paragraph num="(e)"> <text>Special diets or dietary restrictions;</text> </paragraph> <paragraph num="(f)"> <text>Family or legal representative contact information; and</text> </paragraph> <paragraph num="(g)"> <text>Advance directives, living will, or a copy of the resident’s Maryland’s Medical Orders for Life-Sustaining Treatment (MOLST) form.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The brief medical fact sheet for each resident described in §A(3) of this regulation shall be:</text> <paragraph num="(a)"> <text>Updated upon the occurrence of any change of information on the medical fact sheet;</text> </paragraph> <paragraph num="(b)"> <text>Reviewed at least monthly; and</text> </paragraph> <paragraph num="(c)"> <text>Maintained in a written, electronic, or printed form in a central location readily accessible and available to accompany residents in case of an emergency evacuation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The licensee shall review the emergency and disaster plan at least annually and update the plan as necessary.</text> </paragraph> <paragraph num="(6)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Identify a facility, facilities, alternate location, or alternate locations that have agreed to house the licensee's residents during an emergency evacuation; and</text> </paragraph> <paragraph num="(b)"> <text>Document an agreement with each facility or location.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and</text> </paragraph> <paragraph num="(b)"> <text>Document an agreement with each transportation source.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Upon request, a licensee shall provide a copy of the facility's emergency and disaster plan to the local emergency management organization for the purposes of coordinating local emergency planning. The licensee shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization.</text> </paragraph> <paragraph num="(9)"> <text>The licensee shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison's contact information to the local emergency management organization.</text> </paragraph> <paragraph num="(10)"> <text>The licensee shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The summary shall, at a minimum:</text> <paragraph num="(a)"> <text>List means of potential transportation to be used in the event of evacuation;</text> </paragraph> <paragraph num="(b)"> <text>List potential alternative facilities or locations to be used in the event of evacuation;</text> </paragraph> <paragraph num="(c)"> <text>Describe means of communication with family members and legal representatives;</text> </paragraph> <paragraph num="(d)"> <text>Describe the role and responsibilities of the resident, family member, or legal representative in the event of an emergency situation; and</text> </paragraph> <paragraph num="(e)"> <text>Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Maryland Health Alert Network.</text> <paragraph num="(a)"> <text>A nursing home shall register with the Maryland Health Alert Network.</text> </paragraph> <paragraph num="(b)"> <text>A nursing home shall register at least four representatives, including the administrator and the director of nursing.</text> </paragraph> <paragraph num="(c)"> <text>Following any changes in the initial registration of the four representatives, a nursing home shall update the information within 5 business days of the change.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Identify an emergency and disaster planning liaison for the nursing home; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the liaison’s contact information to the local emergency management organization.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>The licensee shall prepare an executive summary of the nursing home’s evacuation procedures to provide to a resident, family member, or resident’s representative upon request. The summary shall, at a minimum:</text> <paragraph num="(a)"> <text>List potential means of transportation to be used in the event of evacuation;</text> </paragraph> <paragraph num="(b)"> <text>List potential alternative facilities or locations to be used in the event of evacuation;</text> </paragraph> <paragraph num="(c)"> <text>Describe means of communication with family members and resident’s representatives;</text> </paragraph> <paragraph num="(d)"> <text>Describe the role and responsibilities of the resident, family member, or resident’s representative in the event of an emergency situation; and</text> </paragraph> <paragraph num="(e)"> <text>Notify families that the information provided may change depending on the nature or scope of the emergency or disaster.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor.</text> </paragraph> <paragraph num="C."> <text>Orientation and Drills.</text> <paragraph num="(1)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Orient staff to the emergency and disaster plan and to their individual responsibilities in relation to the plan within 24 hours of the commencement of job duties;</text> </paragraph> <paragraph num="(b)"> <text>Document completion of the orientation in the staff member’s personnel file through the signature of the employee; and</text> </paragraph> <paragraph num="(c)"> <text>Within 24 hours of admission, notify and direct residents to the nursing home’s emergency plans and maps, including evacuation procedures.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fire Drills.</text> <paragraph num="(a)"> <text>The licensee shall conduct fire drills at least quarterly on all shifts.</text> </paragraph> <paragraph num="(b)"> <text>The licensee shall:</text> <paragraph num="(i)"> <text>Document completion of each drill;</text> </paragraph> <paragraph num="(ii)"> <text>Have all staff who participated in the drill sign the document; and</text> </paragraph> <paragraph num="(iii)"> <text>Maintain the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Semiannual Emergency and Disaster Drill.</text> <paragraph num="(a)"> <text>The licensee shall conduct a semiannual emergency and disaster drill on all shifts during which the facility practices evacuating residents or sheltering in place so that each is practiced at least one time a year.</text> </paragraph> <paragraph num="(b)"> <text>The drills may be conducted via a table-top exercise if the licensee can demonstrate that moving residents will be harmful to the residents.</text> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall:</text> <paragraph num="(i)"> <text>Document completion of each drill or training session;</text> </paragraph> <paragraph num="(ii)"> <text>Have all staff who participated in the drill or training sign the document;</text> </paragraph> <paragraph num="(iii)"> <text>Document any opportunities for improvement as identified as a result of the drill; and</text> </paragraph> <paragraph num="(iv)"> <text>Keep the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The licensee shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Physical Plant — New and Existing Construction Requirements."> <paragraph num="A."> <text>Construction of a New Nursing Home.</text> <paragraph num="(1)"> <text>A new nursing home shall be constructed, equipped, and maintained to protect the health and safety of residents, personnel, and the public.</text> </paragraph> <paragraph num="(2)"> <text>A nursing home desiring to provide services other than those for which it is already licensed shall obtain prior approval from the Department.</text> </paragraph> <paragraph num="(3)"> <text>The nursing home shall obtain prior approval from the Department for any part of the premises to be used for tenant occupancy or for unrelated business purposes.</text> </paragraph> <paragraph num="(4)"> <text>A nursing home shall be constructed in accordance with the provisions of the NFPA 101 Life Safety Code.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Construction in an Existing Structure. In existing structures, the Department shall entertain requests for waivers on items that:</text> <paragraph num="(1)"> <text>Will not endanger the health and safety of residents, visitors, employees, and other individuals using the nursing home; and</text> </paragraph> <paragraph num="(2)"> <text>If corrected, will result in an unreasonable, substantial financial burden on the nursing home.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Conversion of an Existing Structure. When an owner plans to convert an existing structure that has not been licensed as a nursing or care home to a nursing home, the owner shall be required to meet all conditions set forth in this chapter.</text> </paragraph> <paragraph num="D."> <text>Preventative Maintenance Program. A nursing home shall have a documented preventative maintenance program. This program shall include:</text> <paragraph num="(1)"> <text>Periodic service and testing of items as recommended by manufacturers of at least the following:</text> <paragraph num="(a)"> <text>Building systems;</text> </paragraph> <paragraph num="(b)"> <text>Building components;</text> </paragraph> <paragraph num="(c)"> <text>Resident care equipment;</text> </paragraph> <paragraph num="(d)"> <text>Resident therapy equipment;</text> </paragraph> <paragraph num="(e)"> <text>Resident bathing and shower equipment;</text> </paragraph> <paragraph num="(f)"> <text>Furniture and furnishings;</text> </paragraph> <paragraph num="(g)"> <text>Wheelchairs;</text> </paragraph> <paragraph num="(h)"> <text>Walkers;</text> </paragraph> <paragraph num="(i)"> <text>Body lifts;</text> </paragraph> <paragraph num="(j)"> <text>Scales;</text> </paragraph> <paragraph num="(k)"> <text>Electronics; and</text> </paragraph> <paragraph num="(l)"> <text>Electrical switches and outlets;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ongoing staff monitoring for evidence of malfunction or deterioration; and</text> </paragraph> <paragraph num="(3)"> <text>A centralized system for reporting and monitoring repairs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="Physical Plant — General Requirements."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>A nursing home shall comply with all applicable federal, State, and local governing laws, regulations, standards, ordinances, and codes.</text> </paragraph> <paragraph num="C."> <text>A nursing home shall be constructed to comply with the provisions of the NFPA 101 Life Safety Code, as promulgated by the State Fire Prevention Commission, that are applicable to nursing homes.</text> </paragraph> <paragraph num="D."> <text>Securely anchored handrails:</text> <paragraph num="(1)"> <text>Shall be provided on each side of all corridors in resident areas; and</text> </paragraph> <paragraph num="(2)"> <text>May not be more than 36 inches high as measured from the floor to the top of the handrail.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Elevators.</text> <paragraph num="(1)"> <text>New Construction. Elevators shall meet the requirements for elevators in a long-term care nursing home as set forth in the Guidelines for Design and Construction of Residential, Health, Care, and Support Facilities.</text> </paragraph> <paragraph num="(2)"> <text>Existing Facilities. An existing nursing home shall meet all local codes and standards for safety and maintenance of institutional elevators.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Lighting.</text> <paragraph num="(1)"> <text>A resident’s room shall:</text> <paragraph num="(a)"> <text>Be lighted by outside windows; and</text> </paragraph> <paragraph num="(b)"> <text>Have artificial light adequate for reading and other uses as required.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to prevent accidents and promote efficiency of service, the nursing home shall ensure that the following areas have sufficient artificial lighting:</text> <paragraph num="(a)"> <text>Entrances;</text> </paragraph> <paragraph num="(b)"> <text>Hallways;</text> </paragraph> <paragraph num="(c)"> <text>Stairways;</text> </paragraph> <paragraph num="(d)"> <text>Inclines;</text> </paragraph> <paragraph num="(e)"> <text>Ramps;</text> </paragraph> <paragraph num="(f)"> <text>Basements;</text> </paragraph> <paragraph num="(g)"> <text>Attics;</text> </paragraph> <paragraph num="(h)"> <text>Storerooms;</text> </paragraph> <paragraph num="(i)"> <text>Kitchens;</text> </paragraph> <paragraph num="(j)"> <text>Laundries; and</text> </paragraph> <paragraph num="(k)"> <text>Service units.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Minimally Maintained Lighting Levels. The following table lists the minimum lighting requirements in the following given areas:</text> </paragraph> <paragraph num="H."> <text>Night Lights.</text> <paragraph num="(1)"> <text>A nursing home shall have sufficient lighting at night in the following areas:</text> <paragraph num="(a)"> <text>Hallways;</text> </paragraph> <paragraph num="(b)"> <text>Stairs; and</text> </paragraph> <paragraph num="(c)"> <text>Designated toilets of the nursing home for the safety of the resident who gets up during the night.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>There shall be at least one night light in each bedroom for residents.</text> </paragraph> <paragraph num="(3)"> <text>In new construction, the night light shall be located at the resident room door and be capable of being switched on and off.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Screens.</text> <paragraph num="(1)"> <text>A nursing home shall ensure that screened doors and windows are installed and maintained in accordance with applicable fire and safety codes and COMAR 10.15.03 Food Service Facilities.</text> </paragraph> <paragraph num="(2)"> <text>Maintenance and installation may not conflict with other applicable laws, regulations, codes, or ordinances.</text> </paragraph> <paragraph num="(3)"> <text>A nursing home shall equip all screened doors with self-closing devices, to provide for the normal flow of ingress and egress of traffic.</text> </paragraph> <paragraph num="(4)"> <text>A nursing home shall screen with wire screen or its equivalent, not less than 16 meshes per linear inch for doors and windows that provide ventilation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Garbage Disposal.</text> <paragraph num="(1)"> <text>Garbage shall be:</text> <paragraph num="(a)"> <text>Stored in water-tight containers with tight-fitting covers; and</text> </paragraph> <paragraph num="(b)"> <text>Emptied at frequent intervals.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Soiled containers shall be thoroughly scoured and aired before using again.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Garbage Storage Space. Storage space shall be provided for garbage and trash awaiting pickup.</text> </paragraph> <paragraph num="L."> <text>Burning. A nursing home may not burn or incinerate garbage at the nursing home.</text> </paragraph> <paragraph num="M."> <text>Special Medical Wastes. The nursing home shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06.</text> </paragraph> <paragraph num="N."> <text>Smoking.</text> <paragraph num="(1)"> <text>Resident Smoking Requirements.</text> <paragraph num="(a)"> <text>A resident who smokes shall be assessed for safe smoking behaviors at admission and on significant changes in condition.</text> </paragraph> <paragraph num="(b)"> <text>A resident assessed to exhibit unsafe behaviors shall have a care plan to ensure the resident is safe when smoking.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nursing Home Smoking Requirements.</text> <paragraph num="(a)"> <text>Smoking areas shall be designated.</text> </paragraph> <paragraph num="(b)"> <text>Smoking shall be prohibited at the main entrance to all facilities.</text> </paragraph> <paragraph num="(c)"> <text>All tobacco products shall be extinguished and disposed of in noncombustible containers with self-closing lids in accordance with the provisions of NFPA 101 Life Safety Code.</text> </paragraph> </paragraph> </paragraph> <paragraph num="O."> <text>A nursing home shall be protected throughout the entire building by an automatic fire extinguishing system.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".43" heading="Physical Plant — Plumbing."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Plumbing.</text> <paragraph num="(1)"> <text>Plumbing shall be installed in conformance with all applicable federal, State, and local codes and ordinances.</text> </paragraph> <paragraph num="(2)"> <text>Plumbing and water supplies shall be protected against backflow within a nursing home.</text> </paragraph> <paragraph num="(3)"> <text>Prevention of backflow shall be ensured by proper installation of:</text> <paragraph num="(a)"> <text>Plumbing cross-connections;</text> </paragraph> <paragraph num="(b)"> <text>Submerged inlets; and</text> </paragraph> <paragraph num="(c)"> <text>Back siphonage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Sewage. The nursing home shall be serviced by a public sewage disposal system if available.</text> </paragraph> <paragraph num="D."> <text>Private Sewage Disposal Approval.</text> <paragraph num="(1)"> <text>If no approved public sewerage system is available, a private sewage disposal may be used, if it is approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Private sewage disposal systems shall comply with COMAR 26.04.02.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Water Supply. A nursing home shall be served by water from a safe public water supply, if available, as determined by the Department.</text> </paragraph> <paragraph num="F."> <text>Approval of Private Water Supply.</text> <paragraph num="(1)"> <text>If a safe public water supply is not available, a private water supply may be used if it is approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Private water systems shall comply with all federal, State, and local requirements.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Emergency Procedures. Emergency procedures shall be established and documented that enable the nursing home to provide water in all essential areas in the event of the loss of the normal water supply or if the nursing home would have to shelter in place during an emergency or disaster. These written procedures shall:</text> <paragraph num="(1)"> <text>Be a part of the nursing home’s Emergency and Disaster Plan, in conformance with Regulation .40 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Describe the nursing home’s plan to ensure that there is an adequate amount of safe drinking water for all residents and staff for a minimum of 72 hours.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Adequacy of Pressure.</text> <paragraph num="(1)"> <text>The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve equipment in the nursing home.</text> </paragraph> <paragraph num="(2)"> <text>A minimum pressure of 15 psi during demand period is required at top floor equipment.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Temperature. The water heating equipment shall supply adequate amounts of heated water according to the following temperature guidelines for:</text> <paragraph num="(1)"> <text>Resident use, the water temperature shall be between 100°F (38°C) and 120°F (49°C):</text> <paragraph num="(a)"> <text>Washing;</text> </paragraph> <paragraph num="(b)"> <text>Bathing; and</text> </paragraph> <paragraph num="(c)"> <text>Other personal use;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Food preparation use, as referenced in COMAR 10.15.03; and</text> </paragraph> <paragraph num="(3)"> <text>Laundry use, as referenced in the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".44" heading="Physical Plant — Heating and Cooling."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Temperatures. A nursing home shall maintain a minimum design temperature of 75°F or 24°C for all occupied areas.</text> </paragraph> <paragraph num="C."> <text>Heating System. A nursing home shall be equipped with a properly maintained and operational central heating system. The heating system shall be:</text> <paragraph num="(1)"> <text>Capable of maintaining 75°F or 24°C throughout the residents’ section of the building with the outside temperature as prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities; and</text> </paragraph> <paragraph num="(2)"> <text>In compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and other applicable codes, and all federal, State, and local codes.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Humidity. The humidity shall be controlled according to the guidelines prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.</text> </paragraph> <paragraph num="E."> <text>Auxiliary Heat. Appropriate provisions shall be made for emergency auxiliary heat by means of alternative sources of electric power, alternative fuels, or standby equipment.</text> </paragraph> <paragraph num="F."> <text>Space Heaters. Space heaters and portable heaters may not be used.</text> </paragraph> <paragraph num="G."> <text>Boiler rooms. Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and to limit temperatures in working stations to 97°F or 36°C.</text> </paragraph> <paragraph num="H."> <text>Air Conditioning.</text> <paragraph num="(1)"> <text>A nursing home shall be equipped with a properly maintained air conditioning system.</text> </paragraph> <paragraph num="(2)"> <text>The air conditioning system shall be in compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and all federal, State, and local codes.</text> </paragraph> <paragraph num="(3)"> <text>In an existing structure, the nursing home shall comply with the regulations and building codes effective at the date of construction.</text> </paragraph> <paragraph num="(4)"> <text>In new construction or renovation, the nursing home shall comply with the regulations and building codes effective at the date of construction or renovation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".45" heading="Physical Plant — Ventilation."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>An existing nursing home shall provide for adequate ventilation through windows or mechanical means or a combination of both.</text> </paragraph> <paragraph num="C."> <text>A new nursing home shall adhere to the requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>Ventilation System Details.</text> <paragraph num="(1)"> <text>All air-supply and air-exhaust systems shall be mechanically operated.</text> </paragraph> <paragraph num="(2)"> <text>The ventilation rates shown in Table 1 under §D(10) of this regulation shall be considered the minimum acceptable rates and may not be construed as precluding the use of higher ventilation rates.</text> </paragraph> <paragraph num="(3)"> <text>All fans serving exhaust systems shall be located at the discharge end of the system.</text> </paragraph> <paragraph num="(4)"> <text>Outdoor air intakes shall be located:</text> <paragraph num="(a)"> <text>As far as practical but not less than 25 feet from:</text> <paragraph num="(i)"> <text>Exhaust outlets of ventilating systems;</text> </paragraph> <paragraph num="(ii)"> <text>Combustion equipment stacks;</text> </paragraph> <paragraph num="(iii)"> <text>Medical-surgical vacuum systems;</text> </paragraph> <paragraph num="(iv)"> <text>Plumbing vent stacks; or</text> </paragraph> <paragraph num="(v)"> <text>Areas that may collect vehicular exhaust and other noxious fumes; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>As high as practical, so that the bottom of the outdoor air intake is:</text> <paragraph num="(i)"> <text>At least 6 feet above ground level; or</text> </paragraph> <paragraph num="(ii)"> <text>At least 3 feet above roof level.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>The ventilation systems shall be designed and balanced to provide the pressure relationships as shown in Table 1 under §D(10) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>The bottoms of ventilation openings may not be not less than 3 inches above the floor of any room.</text> </paragraph> <paragraph num="(7)"> <text>Corridors may not be used to supply air to or exhaust air from any room, except that air from corridors may be used to ventilate bathrooms, toilet rooms, janitors’ closets, and small electrical or telephone closets opening directly on corridors.</text> </paragraph> <paragraph num="(8)"> <text>Filters.</text> <paragraph num="(a)"> <text>A central ventilation or air conditioning system shall be equipped with filters having efficiencies no less than those specified in Table 2 under §D(11) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>The filter bed shall be located upstream of the air conditioning equipment, unless a prefilter is employed.</text> </paragraph> <paragraph num="(c)"> <text>If a prefilter is employed, the prefilter shall be upstream of the equipment and the main filter bed may be located further downstream.</text> </paragraph> <paragraph num="(d)"> <text>A filter or filter efficiency shall comply with the standards of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.</text> </paragraph> <paragraph num="(e)"> <text>A filter frame shall be durable and carefully dimensioned and shall have an airtight fit with the enclosing duct work.</text> </paragraph> <paragraph num="(f)"> <text>A joint between filter segments and the enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage.</text> </paragraph> <paragraph num="(g)"> <text>A manometer shall be installed across each filter bed serving central air systems.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Air Ducts.</text> <paragraph num="(a)"> <text>Air-handling duct systems shall meet the requirements applicable to nursing homes cited in NFPA 99 Health Care Facilities Code.</text> </paragraph> <paragraph num="(b)"> <text>Fire and smoke dampers shall be constructed, located, and installed in accordance with the requirements of NFPA 101 Life Safety Code.</text> </paragraph> <paragraph num="(c)"> <text>Air ducts that pass through a required smoke barrier shall be provided with a smoke damper at the barrier.</text> </paragraph> <paragraph num="(d)"> <text>Smoke dampers shall activate by smoke detectors located in the ducts at the smoke barrier, or by the smoke detectors used to close smoke barrier doors.</text> </paragraph> <paragraph num="(e)"> <text>Smoke dampers shall be controlled to close automatically to prevent flow of smoke-laden air in either direction.</text> </paragraph> <paragraph num="(f)"> <text>Smoke dampers shall be equipped with automatic remote control reset devices, except that manual reopening will be permitted if smoke dampers are accessible.</text> </paragraph> <paragraph num="(g)"> <text>All devices shall be interlocked with the fire alarm system.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Table 1. This table refers to the pressure relationships and ventilation of certain areas of a nursing home other than chronic disease hospitals.</text> </paragraph> <paragraph num="(11)"> <text>Table 2. This table refers to the filter efficiencies for central ventilation and air conditioning systems in a nursing home other than chronic disease hospitals.</text> </paragraph> <paragraph num="(12)"> <text>Exhaust Hoods. All hoods over cooking surfaces shall comply with the requirements as provided in COMAR 10.15.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".46" heading="Physical Plant — Emergency Power."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Emergency Electrical Power.</text> <paragraph num="(1)"> <text>The nursing home shall provide emergency electrical power.</text> </paragraph> <paragraph num="(2)"> <text>Emergency power for the purpose of egress lighting and protection shall be as required by NFPA 101 Life Safety Code.</text> </paragraph> <paragraph num="(3)"> <text>Other emergency lighting shall be as follows:</text> <paragraph num="(a)"> <text>Nursing station;</text> </paragraph> <paragraph num="(b)"> <text>Drug distribution station or unit dose storage;</text> </paragraph> <paragraph num="(c)"> <text>A lighted area for emergency telephone use;</text> </paragraph> <paragraph num="(d)"> <text>Boiler or mechanical room;</text> </paragraph> <paragraph num="(e)"> <text>Kitchen;</text> </paragraph> <paragraph num="(f)"> <text>Generator set location and switch gear location;</text> </paragraph> <paragraph num="(g)"> <text>Elevator, if operable on emergency power;</text> </paragraph> <paragraph num="(h)"> <text>Areas where life support equipment is used;</text> </paragraph> <paragraph num="(i)"> <text>If applicable, lighting for the common area of refuge; and</text> </paragraph> <paragraph num="(j)"> <text>If applicable, lighting in toilet rooms of the common area of refuge.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Emergency power shall be provided for the:</text> <paragraph num="(a)"> <text>Nurses’ call system;</text> </paragraph> <paragraph num="(b)"> <text>Duplex receptacles installed 50 feet apart in all corridors in resident areas or appropriately located duplex receptacles in the common area of refuge;</text> </paragraph> <paragraph num="(c)"> <text>Telephone service with at least one telephone available for incoming and outgoing calls;</text> </paragraph> <paragraph num="(d)"> <text>Fire pump;</text> </paragraph> <paragraph num="(e)"> <text>Sewerage pump and sump pump;</text> </paragraph> <paragraph num="(f)"> <text>Elevator, if required, for evacuation as referenced in NFPA 101 Life Safety Code;</text> </paragraph> <paragraph num="(g)"> <text>Heating equipment, if applicable, to maintain a minimum temperature of 71°F or 22°C in the common areas of refuge;</text> </paragraph> <paragraph num="(h)"> <text>Life support equipment;</text> </paragraph> <paragraph num="(i)"> <text>Nonflammable medical gas systems;</text> </paragraph> <paragraph num="(j)"> <text>Computer system, if applicable, to enable use of electronic medical records system; and</text> </paragraph> <paragraph num="(k)"> <text>Refrigerated medication storage.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Common Area or Areas of Refuge.</text> <paragraph num="(a)"> <text>The nursing home shall provide a common area or areas of refuge in an emergency situation if all resident rooms, day rooms, and toilet rooms are not tied into the emergency generator to provide heat and cooling.</text> </paragraph> <paragraph num="(b)"> <text>The common area or areas of refuge:</text> <paragraph num="(i)"> <text>Shall be at least 30 square feet per bed, not including corridors;</text> </paragraph> <paragraph num="(ii)"> <text>May not include toilet rooms in the 30 square feet per bed; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall maintain a minimum temperature of 71°F or 22°C and a maximum temperature of 81°F or 27°C.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The nursing home shall provide heated toilet rooms adjacent to the common areas of refuge.</text> </paragraph> <paragraph num="(d)"> <text>The nursing home shall provide a Department-approved written plan that:</text> <paragraph num="(i)"> <text>Defines the specified area of refuge;</text> </paragraph> <paragraph num="(ii)"> <text>Outlines paths of egress from the common areas of refuge; and</text> </paragraph> <paragraph num="(iii)"> <text>Describes provisions for light, heat, food service, washing, and toileting residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Emergency Power Source.</text> <paragraph num="(a)"> <text>The emergency power source shall be a generating set and prime mover located on the premises with automatic transfer.</text> </paragraph> <paragraph num="(b)"> <text>The emergency generator shall:</text> <paragraph num="(i)"> <text>In the event of failure of the normal electrical service, be activated immediately;</text> </paragraph> <paragraph num="(ii)"> <text>Come to full speed and load acceptance within 10 seconds;</text> </paragraph> <paragraph num="(iii)"> <text>Have a capacity of 48 hours of operation from fuel stored on-site; and</text> </paragraph> <paragraph num="(iv)"> <text>Be tested once a month, for at least 30 minutes under normal emergency nursing home connected load, and the test recorded in a permanent log book maintained for that purpose.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".47" heading="Nursing Care Unit."> <paragraph num="A."> <text>Size. Nursing care units may not exceed 60 beds. The Department may specify the numbers and types of personnel for each unit which exceeds 40 beds.</text> </paragraph> <paragraph num="B."> <text>Common Space. The nursing home shall provide a living room for residents’ use with a sufficient number of reading lamps, tables, and comfortable chairs or sofas.</text> </paragraph> <paragraph num="C."> <text>Service Areas Required.</text> <paragraph num="(1)"> <text>Nurses’ Work Area.</text> <paragraph num="(a)"> <text>The nurses’ work area shall be located on the unit and within easy view of corridors outside of residents’ rooms.</text> </paragraph> <paragraph num="(b)"> <text>The Department may specify the location and size of a nurses’ work area which serves a nursing care unit exceeding 40 beds.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nursing Care Unit.</text> <paragraph num="(a)"> <text>A nursing care unit, regardless of size, including special care units, shall be equipped as described in this regulation.</text> </paragraph> <paragraph num="(b)"> <text>A nursing care unit bathroom shall include:</text> <paragraph num="(i)"> <text>A toilet, within the care unit, for the use of personnel; and</text> </paragraph> <paragraph num="(ii)"> <text>A hand-washing sink equipped with goose-neck spout, separate soap dispenser, and disposable paper towel dispenser.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A nursing care unit’s medicine shall be stored in accordance with the following procedures:</text> <paragraph num="(i)"> <text>Shall be stored in a cabinet with locks;</text> </paragraph> <paragraph num="(ii)"> <text>Schedule II drugs shall be kept in a separately locked, securely fixed box or drawer in the medicine storage cabinet under two locks, keyed differently;</text> </paragraph> <paragraph num="(iii)"> <text>The medicine storage and preparation area shall be illuminated with at least 100 foot-candles at the work counter;</text> </paragraph> <paragraph num="(iv)"> <text>The preparation area shall include a small sink set into the counter or with drain boards and a biological refrigerator; and</text> </paragraph> <paragraph num="(v)"> <text>The medicine storage cabinet, medicine preparation area, and biological refrigerator shall be under the direct visual control of the nursing or pharmacy staff.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Nurses' call system.</text> </paragraph> <paragraph num="(e)"> <text>Charting desk and supplies.</text> </paragraph> <paragraph num="(f)"> <text>Storage space for miscellaneous medical supplies which shall be protected from contamination.</text> </paragraph> <paragraph num="(g)"> <text>A nursing care unit shall have sufficient space and equipment for medical records so that personnel can function effectively and maintain easily accessible records for all residents.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medication Storage in Nursing Home.</text> <paragraph num="(a)"> <text>The storage facility shall provide for the conditions listed in §C(3)(b)—(g) of this regulation when prescribed.</text> </paragraph> <paragraph num="(b)"> <text>Cold — Any temperature at or below 46°F or 8°C. A refrigerator is a cold place in which the temperature is maintained thermostatically between 46°F and 59°F or 8°C and 15°C. A freezer is a cold place in which the temperature is maintained thermostatically between -4°F and -14°F or -20°C and -26°C.</text> </paragraph> <paragraph num="(c)"> <text>Cool — Any temperature between 46°F and 59°F or 8°C and 15°. An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph.</text> </paragraph> <paragraph num="(d)"> <text>Room Temperature — The temperature prevailing in a working area. Controlled room temperature is a temperature maintained thermostatically between 59°F and 86° F or 15°C and 30°C.</text> </paragraph> <paragraph num="(e)"> <text>Warm — Any temperature between 86°F and 104°F or 30°C and 40°C.</text> </paragraph> <paragraph num="(f)"> <text>Excessive Heat — Any temperature above 104°F or 40°C.</text> </paragraph> <paragraph num="(g)"> <text>Protection from Freezing. The container label bears appropriate instructions to protect the product from freezing when freezing it may subject a product to:</text> <paragraph num="(i)"> <text>Loss of strength or potency;</text> </paragraph> <paragraph num="(ii)"> <text>Risk of breakage of the container; or</text> </paragraph> <paragraph num="(iii)"> <text>Destructive alteration of the dosage form.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Storage under Non-specific Conditions. When no specific storage directions or limitations are provided in the individual monograph, the storage conditions shall include protection from moisture, freezing, and excessive heat.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Space for Storage of Linen. Capacity shall be provided for storing of at least two complete linen changes per bed. Clean linen shall be stored separately from unclean items.</text> </paragraph> <paragraph num="(5)"> <text>Janitor Closet — New Construction.</text> <paragraph num="(a)"> <text>A nursing unit shall contain at least one janitor closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies.</text> </paragraph> <paragraph num="(b)"> <text>The janitor closet shall be equipped for hand washing.</text> </paragraph> <paragraph num="(c)"> <text>The janitor closet shall be connected to mechanically operated exhaust ventilation.</text> </paragraph> <paragraph num="(d)"> <text>The plumbing fixture for the utility or service sink within a janitor closet shall be provided with a back-flow prevention device.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Utility Rooms.</text> <paragraph num="(a)"> <text>There shall be separate clean and soiled utility rooms in each nursing unit:</text> <paragraph num="(i)"> <text>Accessible to the resident area;</text> </paragraph> <paragraph num="(ii)"> <text>Each having separate entrances; and</text> </paragraph> <paragraph num="(iii)"> <text>No more than 120 feet to the most remote resident bedroom.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The clean utility room shall contain:</text> <paragraph num="(i)"> <text>A small sink equipped with gooseneck spout and wrist blades;</text> </paragraph> <paragraph num="(ii)"> <text>Soap and individual paper towels in a dispenser;</text> </paragraph> <paragraph num="(iii)"> <text>Adequate storage and work counter space for storage and assembly of supplies for nursing procedures; and</text> </paragraph> <paragraph num="(iv)"> <text>Clean linen stored and transported in covered containers, closed linen carts, or rooms exclusively provided for this purpose.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The soiled utility room shall contain:</text> <paragraph num="(i)"> <text>Work counter with sink, gooseneck faucet, and wrist blades;</text> </paragraph> <paragraph num="(ii)"> <text>A small sink equipped with soap and individual paper towels in a dispenser;</text> </paragraph> <paragraph num="(iii)"> <text>Space for waste receptacles and soiled linen receptacles; provision for storing and transporting soiled linen in covered leakproof containers;</text> </paragraph> <paragraph num="(iv)"> <text>Equipment to clean and sanitize bedpans, urinals, and basins; and</text> </paragraph> <paragraph num="(v)"> <text>Equipment for the disposal of liquid and semi-solid wastes and bodily fluids via the nursing home’s sanitary sewer connection or on-site sewage disposal system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Culture Change Nursing Home. In a culture change nursing home, service areas shall be provided for resident care needs as approved by the Department. The culture change nursing home shall be required to have service areas that meet the specifications in this chapter for:</text> <paragraph num="(a)"> <text>Clean storage;</text> </paragraph> <paragraph num="(b)"> <text>Soiled holding;</text> </paragraph> <paragraph num="(c)"> <text>Laundry;</text> </paragraph> <paragraph num="(d)"> <text>Janitorial services; and</text> </paragraph> <paragraph num="(e)"> <text>Medication storage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Drinking Fountains. One public drinking fountain or comparable equipment as preapproved by the Department shall be provided on each floor, usable from a wheelchair. Alternative means to provide drinking water to residents, staff, and the general public may be used as approved by the Department.</text> </paragraph> <paragraph num="E."> <text>Automated External Defibrillator.</text> <paragraph num="(1)"> <text>A nursing home shall possess a functioning automated external defibrillator (AED).</text> </paragraph> <paragraph num="(2)"> <text>As of July 1, 2020, a nursing home shall install a functioning AED unit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".48" heading="Call Systems."> <paragraph num="A."> <text>Call System.</text> <paragraph num="(1)"> <text>A nurse call system shall be installed and maintained in operating order in all nursing units.</text> </paragraph> <paragraph num="(2)"> <text>A call system shall be maintained in a manner that will provide visible and audible signal communication between nursing service personnel and residents.</text> </paragraph> <paragraph num="(3)"> <text>A call station shall provide readily accessible and detachable extension cords to each resident’s bed in the residents’ rooms at all times.</text> </paragraph> <paragraph num="(4)"> <text>A call system shall have a visible signal above the door of each resident’s bedroom that shall be visible from all parts of the corridor.</text> </paragraph> <paragraph num="(5)"> <text>A call system shall provide visual lights at corridor intersections, in multi-corridor nursing units.</text> </paragraph> <paragraph num="(6)"> <text>A call system shall be provided in each resident’s bathroom and bathing area in locations accessible to the residents.</text> </paragraph> <paragraph num="(7)"> <text>The call system shall enable residents in the rehabilitation area to summon rehabilitation staff.</text> </paragraph> <paragraph num="(8)"> <text>The nurses’ call system shall require resetting at the station where the call originates.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Wireless Call Systems.</text> <paragraph num="(1)"> <text>A call system that uses wireless pagers or other wireless communication devices may be used as an alternative system.</text> </paragraph> <paragraph num="(2)"> <text>A wireless device shall:</text> <paragraph num="(a)"> <text>Be issued to all assigned direct care staff; and</text> </paragraph> <paragraph num="(b)"> <text>Receive signals originating from residents’ bedrooms, bathrooms, bathing areas, and therapy areas.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The use of an approved wireless call system shall eliminate the need to install call light indicators outside the residents’ bedrooms, bathrooms, bathing areas, and therapy areas.</text> </paragraph> <paragraph num="(4)"> <text>A computer system with a monitor or other electronic display device may be installed to replace the call system annunciator, as long as it reveals the location where the signal originated and sounds an audible alert tone. Otherwise, a dedicated annunciator connected to the wireless call system will be needed.</text> </paragraph> <paragraph num="(5)"> <text>An electrically powered call system shall be connected to the emergency power supply.</text> </paragraph> <paragraph num="(6)"> <text>The sounding of the audible signal shall be continuous or intermittent until answered.</text> </paragraph> <paragraph num="(7)"> <text>The audible signal may not be turned off at the nursing station.</text> </paragraph> <paragraph num="(8)"> <text>The audible signal shall be loud enough to be heard at the nurses’ station.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".49" heading="Resident Bedroom in Nursing Home."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home unless a waiver has been granted by the Office of Health Care Quality in accordance with Regulation .03G of this chapter.</text> </paragraph> <paragraph num="B."> <text>Bedroom Accommodations.</text> <paragraph num="(1)"> <text>Bedroom.</text> <paragraph num="(a)"> <text>A resident’s room shall have direct access to an exit in accordance with the requirements applicable to nursing homes specified in NFPA 101 Life Safety Code.</text> </paragraph> <paragraph num="(b)"> <text>A room that opens into the kitchen may not be used as a resident bedroom.</text> </paragraph> <paragraph num="(c)"> <text>A room may not be used as a resident bedroom if it can only be reached by passing through a kitchen.</text> </paragraph> <paragraph num="(d)"> <text>Residents may not occupy rooms extending below the ground level.</text> </paragraph> <paragraph num="(e)"> <text>No more than four individuals may occupy a multiple occupancy bedroom.</text> </paragraph> <paragraph num="(f)"> <text>Residents’ beds may not be located near radiators, registers, or sources of draft.</text> </paragraph> <paragraph num="(g)"> <text>Adequate storage space shall be provided in each bedroom to allow each resident to keep necessary items of clothing, including items that need to be hung. Adequate storage space shall be provided for residents’ personal possessions, including the storage of seasonal clothing.</text> </paragraph> <paragraph num="(h)"> <text>All occupants of any bedroom shall be of the same sex, except in the case of a two-bed room occupied by:</text> <paragraph num="(i)"> <text>Siblings;</text> </paragraph> <paragraph num="(ii)"> <text>A parent and child;</text> </paragraph> <paragraph num="(iii)"> <text>A married couple; or</text> </paragraph> <paragraph num="(iv)"> <text>Consenting residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Bedroom — New Construction. A nursing home shall provide cubicle curtains and tracks in multiple occupancy bedrooms between beds to ensure privacy of residents.</text> </paragraph> <paragraph num="(3)"> <text>Bedroom — Existing Construction. In an existing nursing home, curtains or screens shall be acceptable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Floor and Window Space.</text> <paragraph num="(1)"> <text>Floors.</text> <paragraph num="(a)"> <text>A distance of at least 3 feet shall be maintained between each bed. Beds are to be placed so that all sides of the bed are at least 18 inches from heating units.</text> </paragraph> <paragraph num="(b)"> <text>The following shall be considered a minimum allowance of floor space:</text> <paragraph num="(i)"> <text>100 square feet, single-bed room; and</text> </paragraph> <paragraph num="(ii)"> <text>80 square feet, per bed, for multiple-bed rooms.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The following floor areas may not be included in the calculation of floor space:</text> <paragraph num="(i)"> <text>Toilet rooms and bathing facilities;</text> </paragraph> <paragraph num="(ii)"> <text>Closets;</text> </paragraph> <paragraph num="(iii)"> <text>The floor area occupied by wardrobes, bureaus, or lockers, when permanently installed as part of walls or ceilings and as a permanent component of a bedroom;</text> </paragraph> <paragraph num="(iv)"> <text>HVAC equipment, including any steam, water, or electrical supply or return lines that may run parallel to the floor or interrupt the floor surface;</text> </paragraph> <paragraph num="(v)"> <text>Support columns, pipe chases, or other structures, whether free-standing or as an integral part of a wall; and</text> </paragraph> <paragraph num="(vi)"> <text>The arc of any doors that open into the room, excluding closet doors.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The minimum horizontal dimensions of a bedroom shall be 10 feet to:</text> <paragraph num="(i)"> <text>Facilitate the placement of beds as required in Regulation .44 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Maintain a minimum clearance of 3 feet at the foot of the bed.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>In an existing nursing home, the usable floor area for rooms having a bedroom shall have a finished ceiling height of 8 feet. For a bedroom that has sloping walls, only 50 percent of the floor area with a ceiling height between 4 feet and 7 feet, 6 inches, shall be credited, provided that at least 50 percent of the total area of the bedroom has a ceiling height of 8 feet.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Windows.</text> <paragraph num="(a)"> <text>The window area within each bedroom shall be at least 10 square feet per bed. The window opening shall be at least 28 inches so that the total area equals 10 square feet per bed. This is to allow entry of fire fighters, removal of smoke, and emergency evacuation.</text> </paragraph> <paragraph num="(b)"> <text>The maximum height from the floor to the top of a window sill shall be 44 inches above the finished floor.</text> </paragraph> <paragraph num="(c)"> <text>A portable window air-conditioning unit may not block window space. The installation of a portable air-conditioning unit shall be approved by the:</text> <paragraph num="(i)"> <text>Local fire authorities; and</text> </paragraph> <paragraph num="(ii)"> <text>Department.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If windows cannot be opened for ventilation, a central HVAC system shall be provided and maintained.</text> </paragraph> <paragraph num="(e)"> <text>If windows can be opened, but the nursing home has concern over the window being opened due to resident safety issues and elopement, the window sash may be restricted by hardware as approved by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Furnishings.</text> <paragraph num="(1)"> <text>Furnishings.</text> <paragraph num="(a)"> <text>The nursing home shall provide residents with their own bed. The bed shall be at least 36 inches wide and be substantially constructed. Rollaway type beds, cots, or folding beds may not be used.</text> </paragraph> <paragraph num="(b)"> <text>Bed.</text> <paragraph num="(i)"> <text>Each bed provided shall be in good repair, with a clean and comfortable standard size mattress and foundation.</text> </paragraph> <paragraph num="(ii)"> <text>To avoid injury to the resident, the mattress and foundation shall fit the bed.</text> </paragraph> <paragraph num="(iii)"> <text>Clean linen and a clean, comfortable pillow shall be provided. Extra pillows shall be available.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Bedroom Furniture. A resident shall be provided with the following furnishings, which shall be convenient to the resident:</text> <paragraph num="(i)"> <text>Bedside stand with a drawer;</text> </paragraph> <paragraph num="(ii)"> <text>Towel hanger;</text> </paragraph> <paragraph num="(iii)"> <text>A comfortable chair;</text> </paragraph> <paragraph num="(iv)"> <text>A chest of drawers with at least one locking drawer;</text> </paragraph> <paragraph num="(v)"> <text>Enclosed space for hanging clothing;</text> </paragraph> <paragraph num="(vi)"> <text>A wall mirror in each room, unless contraindicated by physician’s order; and</text> </paragraph> <paragraph num="(vii)"> <text>A bedside lamp, over-bed lamp, or other directional light source for resident reading and bedside care.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Resident’s Personal Furnishings.</text> <paragraph num="(i)"> <text>A nursing home shall develop policies and procedures to give residents the opportunity to use the resident’s own furnishings as detailed in this chapter.</text> </paragraph> <paragraph num="(ii)"> <text>The nursing home shall make its resident’s personal furnishing policies available for review by residents and the resident’s representative.</text> </paragraph> <paragraph num="(iii)"> <text>These policies shall address the condition of the personal furnishings, presence of insects or vermin, and overall safety to ensure that the use of the resident’s belongings does not create any safety or health issues.</text> </paragraph> <paragraph num="(iv)"> <text>Personal furnishings that are allowed shall be appropriate for the resident’s use.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Windows shall be provided with shades or draperies adequate to control glare and maintain privacy.</text> </paragraph> <paragraph num="(f)"> <text>Each living room for residents’ use shall be provided with a sufficient number of reading lamps, tables, and comfortable chairs or sofas.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Furnishings — New Construction. A bedroom shall be provided with a hand-washing sink with both hot and cold running water unless a toilet or bathroom facility with a sink is connected to the bedroom.</text> </paragraph> <paragraph num="(3)"> <text>Medication Storage Cabinets.</text> <paragraph num="(a)"> <text>Medication storage cabinets with locks shall be permitted for the storage of resident medications that do not require refrigeration within a resident bedroom.</text> </paragraph> <paragraph num="(b)"> <text>Controlled medications to be stored within medication storage cabinets in a resident’s room shall be held within a separate compartment that is locked and inside of the larger medication storage cabinet in that room.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".50" heading="Body-Holding Room."> <paragraph num="A."> <text>Body-Holding Room — New Construction and Existing Nursing Home.</text> <paragraph num="(1)"> <text>A body-holding room shall be equipped with ventilation by mechanical means at the same rate and specifications as designed for soiled linen sorting and storage areas.</text> </paragraph> <paragraph num="(2)"> <text>A nursing home shall develop and implement a method for body-holding that minimizes the psychological effects on other residents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Body-Holding Room — New Construction. A body-holding room shall be located to facilitate quiet and unobtrusive ingress and egress of bodies, convenient to the elevator and with an isolated exit.</text> </paragraph> <paragraph num="C."> <text>Body-Holding Room — Existing Nursing Home. If a body-holding room is not provided, a holding area shall be designated that approximates the above conditions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".51" heading="Resident Bathroom Amenities."> <paragraph num="A."> <text>Bathing.</text> <paragraph num="(1)"> <text>There shall be at least one separate room or compartment with a bathtub, shower, or other bathing device, as approved by the Department, for every 15 licensed beds.</text> </paragraph> <paragraph num="(2)"> <text>The compartment shall be large enough to accommodate:</text> <paragraph num="(a)"> <text>The resident;</text> </paragraph> <paragraph num="(b)"> <text>A caregiver; and</text> </paragraph> <paragraph num="(c)"> <text>A wheelchair, shower chair, or shower bed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Toilets.</text> <paragraph num="(1)"> <text>For every eight beds, there shall be at least one toilet enclosed in a separate room or stall.</text> </paragraph> <paragraph num="(2)"> <text>Each floor shall have at least one toilet room large enough to:</text> <paragraph num="(a)"> <text>Accommodate:</text> <paragraph num="(i)"> <text>The resident;</text> </paragraph> <paragraph num="(ii)"> <text>A wheelchair; and</text> </paragraph> <paragraph num="(iii)"> <text>A caregiver; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Permit toilet assistance or training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Sinks.</text> <paragraph num="(1)"> <text>For every four licensed beds, there shall be at least one hand-washing sink.</text> </paragraph> <paragraph num="(2)"> <text>For hand-washing purposes, there shall be a towel dispenser and a supply of paper towels and soap dispenser adjacent to each sink.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".52" heading="Equipment and Supplies for Bedside Care and Therapy."> <paragraph num="A."> <text>Needs of Residents.</text> <paragraph num="(1)"> <text>There shall be sufficient equipment to meet the needs of the residents admitted.</text> </paragraph> <paragraph num="(2)"> <text>The administrator shall obtain specific items required for individual cases where requested by the attending physician or medical director.</text> </paragraph> <paragraph num="(3)"> <text>The Department may require that the nursing home have specific types of equipment based on the needs of the residents.</text> </paragraph> <paragraph num="(4)"> <text>A nursing home shall establish and enforce a written preventive maintenance program to ensure that all resident care and therapy equipment is maintained in safe operating condition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Use of Hot Packs, Ice Packs, and Other Therapeutic Medical Devices.</text> <paragraph num="(1)"> <text>Covers shall be placed on hot packs, ice packs and other temperature-related therapeutic medical devices before they are placed in a bed or on a resident.</text> </paragraph> <paragraph num="(2)"> <text>The temperatures in the building, hot packs, and therapeutic equipment may not exceed 120°F or 49°C.</text> </paragraph> <paragraph num="(3)"> <text>The use of hot and cold medical devices shall be:</text> <paragraph num="(a)"> <text>Consistent with manufacturer’ guidelines and nursing home policies; and</text> </paragraph> <paragraph num="(b)"> <text>Maintained and applied by trained staff.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".53" heading="Rehabilitation Facilities — Space and Equipment."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>General Requirements.</text> <paragraph num="(1)"> <text>Space.</text> <paragraph num="(a)"> <text>A nursing home shall provide adequate space to:</text> <paragraph num="(i)"> <text>Receive, examine, and treat residents;</text> </paragraph> <paragraph num="(ii)"> <text>Store supplies and equipment, including wheelchairs and stretchers; and</text> </paragraph> <paragraph num="(iii)"> <text>Provide office space for the employed personnel to work.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A nursing home shall allot 75 square feet for treatment area per resident, based on peak treatment schedules.</text> </paragraph> <paragraph num="(c)"> <text>A nursing home shall plan and arrange space for shared use by physical therapy and occupational therapy staff and residents, if scheduling permits.</text> </paragraph> <paragraph num="(d)"> <text>A nursing home may distribute space in the following manner:</text> <paragraph num="(i)"> <text>Storage space shall comprise at least 10 percent of the area designated for exercise and rehabilitation; and</text> </paragraph> <paragraph num="(ii)"> <text>Office space shall be at least 110 square feet for one therapist, or 85 square feet per therapist if there are two or more.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Equipment.</text> <paragraph num="(a)"> <text>Equipment shall allow for providing safe and effective resident care.</text> </paragraph> <paragraph num="(b)"> <text>All electrical equipment shall be calibrated according to the manufacturer's guidelines and shall be serviced periodically as part of a preventive maintenance program. A sticker bearing the date of the most current inspection shall be affixed on each piece of equipment.</text> </paragraph> <paragraph num="(c)"> <text>All electrical equipment shall be tested periodically for proper grounding, current leakage, and calibration where appropriate.</text> </paragraph> <paragraph num="(d)"> <text>The operator’s instruction manual shall be available in a designated location or accessible electronically at all times.</text> </paragraph> <paragraph num="(e)"> <text>All flammables shall be stored in compliance with NFPA 99 Health Care Facilities.</text> </paragraph> <paragraph num="(f)"> <text>Adequate exhaust ventilation shall be provided when using vaporous materials or pollutants.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Toilet Facilities in Rehabilitation Area — New Construction.</text> <paragraph num="(a)"> <text>A nursing home with rehabilitation areas shall provide a hand-washing sink and toilet which meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities standards for residents who use a wheelchair.</text> </paragraph> <paragraph num="(b)"> <text>The nursing home shall be readily accessible to the residents receiving rehabilitative services.</text> </paragraph> <paragraph num="(c)"> <text>Toilets and bathing rooms within a rehabilitation area shall be equipped with a nurse call system.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".54" heading="Dayroom and Dining Area."> <paragraph num="A."> <text>General Requirements. Resident Dining, Occupational Therapy, and Activities Program. The nursing home shall provide one or more attractively furnished areas of adequate size for resident dining, occupational therapy, and social activities. Activities space shall be of adequate size to meet the needs of the residents and shall be located on each floor occupied by residents.</text> </paragraph> <paragraph num="B."> <text>Dining Area.</text> <paragraph num="(1)"> <text>A nursing home shall provide dining areas large enough to accommodate all residents who eat there at the same time.</text> </paragraph> <paragraph num="(2)"> <text>There shall be an allowance of at least 12 square feet per resident. This allowance shall be substantially increased proportionate to the number of residents who use a wheelchair.</text> </paragraph> <paragraph num="(3)"> <text>The height of tables provided in dining areas shall accommodate each resident using a wheelchair.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Dayroom Area. Dayroom areas shall be provided that are:</text> <paragraph num="(1)"> <text>Adequate for the residents located on each nursing care unit; and</text> </paragraph> <paragraph num="(2)"> <text>Located convenient to the residents’ bedrooms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Multi-purpose Room.</text> <paragraph num="(1)"> <text>The nursing home shall provide a multi-purpose room for dining, occupational therapy, physical therapy, and social activities. There shall be sufficient space to accommodate all activities without interfering with each other.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall set aside areas for residents’ dining and recreation that total at least 30 square feet per licensed bed for the first 100 beds, plus 27 square feet per licensed bed for all beds in excess of 100.</text> </paragraph> <paragraph num="(3)"> <text>Areas that meet this requirement may include:</text> <paragraph num="(a)"> <text>Reception areas;</text> </paragraph> <paragraph num="(b)"> <text>Lobbies, portion not required for egress per NFPA 101 Life Safety Code, as are applicable to nursing homes;</text> </paragraph> <paragraph num="(c)"> <text>Hair care;</text> </paragraph> <paragraph num="(d)"> <text>Salon rooms;</text> </paragraph> <paragraph num="(e)"> <text>Resident gift shops;</text> </paragraph> <paragraph num="(f)"> <text>Theater;</text> </paragraph> <paragraph num="(g)"> <text>Auditorium;</text> </paragraph> <paragraph num="(h)"> <text>Spiritual worship;</text> </paragraph> <paragraph num="(i)"> <text>Meditation areas;</text> </paragraph> <paragraph num="(j)"> <text>Dayrooms;</text> </paragraph> <paragraph num="(k)"> <text>Dining areas;</text> </paragraph> <paragraph num="(l)"> <text>Libraries; and</text> </paragraph> <paragraph num="(m)"> <text>No more than 50 percent of the floor area of all occupational therapy and physical therapy areas, and other areas as approved by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".55" heading="Dietetic Service Area."> <paragraph num="A."> <text>General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Food Service Department.</text> <paragraph num="(1)"> <text>The size and location of the food service area shall comply with COMAR 10.15.03.</text> </paragraph> <paragraph num="(2)"> <text>A catered or satellite system shall be covered by a contract approved by the Department.</text> </paragraph> <paragraph num="(3)"> <text>The vendor providing the food shall have a valid food service permit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Outside Service Entrance. A convenient outside service entrance shall exist to facilitate receiving food supplies and the disposal of waste.</text> </paragraph> <paragraph num="D."> <text>Restriction — Entry to Kitchen or Serving Pantry. A toilet room or sleeping room may not open directly into any kitchen or serving pantry.</text> </paragraph> <paragraph num="E."> <text>Limitations on Use of Kitchen. The kitchen may not be used as a passageway. It shall be used for no other purpose than activities connected with food service.</text> </paragraph> <paragraph num="F."> <text>Janitor Closet or Service Area.</text> <paragraph num="(1)"> <text>Janitor Closet — New Construction. A janitor closet or service alcove for the exclusive use of food service areas shall be provided in, or adjacent to, the dietetic service department.</text> </paragraph> <paragraph num="(2)"> <text>The janitor closet or service alcove shall be:</text> <paragraph num="(a)"> <text>Equipped with:</text> <paragraph num="(i)"> <text>A utility sink;</text> </paragraph> <paragraph num="(ii)"> <text>Storage shelves; and</text> </paragraph> <paragraph num="(iii)"> <text>A rack for hanging brooms and mops; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Connected to mechanically operated exhaust ventilation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The plumbing fixture for the utility sink within a janitor’s closet shall be provided with an approved back-flow prevention device.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Space.</text> <paragraph num="(1)"> <text>There shall be sufficient floor space in the food service department to permit all activities to function efficiently without overcrowding or increasing the risk for cross-contamination of food or equipment from soiled surfaces.</text> </paragraph> <paragraph num="(2)"> <text>Minimum Space Requirements — New Construction.</text> </paragraph> <paragraph num="(3)"> <text>Space — Existing Nursing Home.</text> <paragraph num="(a)"> <text>A nursing home that holds full licensure as of the adoption date of these regulations shall be considered to have an adequate size dietetic service department.</text> </paragraph> <paragraph num="(b)"> <text>Renovations of all kitchens shall be approved by the Department, which will consider modification of the minimum space requirement based on space available, costs, and type of service.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Aisle space between working areas shall be at least 3 feet, and aisle space for main traffic shall be at least 5 feet wide.</text> </paragraph> <paragraph num="(5)"> <text>Ceiling height shall be at least 9 feet.</text> </paragraph> <paragraph num="(6)"> <text>If the licensed capacity of a nursing home is increased, or if meals are provided to anyone outside of the nursing home from the food service area of the nursing home, the nursing home shall provide an additional food service area in accordance with this chapter. The additional food service area required when meals are provided to anyone outside of the nursing home is to be calculated by using the total number of individuals to whom meals are provided.</text> </paragraph> <paragraph num="(7)"> <text>The kitchen space requirement as described in this regulation does not apply to occasional special functions such as picnics or dinners for residents, volunteers, families, or community groups as long as the nursing home certifies to the Department that providing meals for a special function will not adversely affect or detract from the timely provision of meals to the nursing home’s residents.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Floor Pantries — New Construction.</text> <paragraph num="(1)"> <text>There shall be at least one food service floor pantry per nursing care unit.</text> </paragraph> <paragraph num="(2)"> <text>This area shall be of sufficient size to accommodate the equipment required for food preparation and service.</text> </paragraph> <paragraph num="(3)"> <text>The equipment provided in food service floor pantries shall comply with the requirements of the local health department.</text> </paragraph> <paragraph num="(4)"> <text>A food service floor pantry shall include the following:</text> <paragraph num="(a)"> <text>Refrigerator;</text> </paragraph> <paragraph num="(b)"> <text>Cabinets for dry storage and supplies;</text> </paragraph> <paragraph num="(c)"> <text>Work space;</text> </paragraph> <paragraph num="(d)"> <text>Sink for purposes other than hand-washing;</text> </paragraph> <paragraph num="(e)"> <text>Hand-washing sink with soap dispenser and disposable paper towel dispenser; and</text> </paragraph> <paragraph num="(f)"> <text>Except for trays that are assembled in the main kitchen and then distributed to the nursing care units, equipment to hold hot food if bulk foods are plated and served to the residents on the nursing care unit.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A food service floor pantry shall include the following additional equipment:</text> <paragraph num="(a)"> <text>Toaster;</text> </paragraph> <paragraph num="(b)"> <text>Ice-making machine or ice-storage container;</text> </paragraph> <paragraph num="(c)"> <text>Work space for tray preparation;</text> </paragraph> <paragraph num="(d)"> <text>Equipment to deliver completed trays;</text> </paragraph> <paragraph num="(e)"> <text>Three-compartment sanitizing sink or dishwasher;</text> </paragraph> <paragraph num="(f)"> <text>Cabinet for dry storage, supplies, and kitchenware; and</text> </paragraph> <paragraph num="(g)"> <text>Storage for trays, tableware, flatware, and utensils.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Equipment for Food Preparation and Distributions.</text> <paragraph num="(1)"> <text>Adequate equipment for preparation, serving, and distribution of food shall be provided.</text> </paragraph> <paragraph num="(2)"> <text>A dumbwaiter, elevator, or ramp shall be provided in a nursing home of more than one story where more than eight residents above or below the kitchen level receive bedside tray service.</text> </paragraph> <paragraph num="(3)"> <text>Equipment to protect food from dust or contamination and to maintain food at proper temperature shall be provided to transport food to the residents.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Dry Food Storage.</text> <paragraph num="(1)"> <text>Food Storage Space.</text> <paragraph num="(a)"> <text>Adequate space shall be provided to store food supplies.</text> </paragraph> <paragraph num="(b)"> <text>The amount of storage space needed to store food depends on the frequency of deliveries.</text> </paragraph> <paragraph num="(c)"> <text>It is recommended that 2 square feet per resident be provided and that the dry food storage area be located within easy access to the receiving area and the kitchen.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The storeroom shall be cool and well-ventilated.</text> </paragraph> <paragraph num="(3)"> <text>All food supplies shall be stored off the floor and away from the wall to allow for cleaning.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Refrigerated Storage.</text> <paragraph num="(1)"> <text>Adequate refrigerated storage, refrigerators, and frozen food storage cabinets shall be provided and regulated to maintain temperatures prescribed in COMAR 10.15.03.</text> </paragraph> <paragraph num="(2)"> <text>Food in storage shall be arranged so that new food items are stored behind old food items.</text> </paragraph> <paragraph num="(3)"> <text>The oldest foods shall be used first, known as the first in, first out method.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Mobile Food Carts.</text> <paragraph num="(1)"> <text>All policies and procedures for the mobile food cart shall be approved by the Department and the nursing home’s local health department before implementation.</text> </paragraph> <paragraph num="(2)"> <text>Policies and procedures shall address, at a minimum the following:</text> <paragraph num="(a)"> <text>Identify how many staff members will assist with serving food items, pushing the mobile cart, and delivering meals to the residents;</text> </paragraph> <paragraph num="(b)"> <text>Ensure proper food protection on three sides to protect the food;</text> </paragraph> <paragraph num="(c)"> <text>Maintain proper temperature control, hot food at a minimum of 135°F and cold food maintained at a maximum of 41°F;</text> </paragraph> <paragraph num="(d)"> <text>Record of temperatures before serving meals on each individual unit;</text> </paragraph> <paragraph num="(e)"> <text>Ensure proper food temperatures; and</text> </paragraph> <paragraph num="(f)"> <text>Hand washing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The hand washing policy and procedures referenced in §L(2)(f) of this regulation shall include the following:</text> <paragraph num="(a)"> <text>Use of a hand sanitizer in lieu of proper hand washing is not permitted;</text> </paragraph> <paragraph num="(b)"> <text>Bare hands may not have direct contact with ready-to-eat food;</text> </paragraph> <paragraph num="(c)"> <text>Hand washing shall be done before starting meal service on each individual unit;</text> </paragraph> <paragraph num="(d)"> <text>When and at what location hand washing will be done;</text> </paragraph> <paragraph num="(e)"> <text>Hand washing may not be done in resident rooms;</text> </paragraph> <paragraph num="(f)"> <text>Access to a hand washing sink may not require the opening of a door;</text> </paragraph> <paragraph num="(g)"> <text>The hand washing sink shall be in a central, unobstructed location;</text> </paragraph> <paragraph num="(h)"> <text>Mobile hand sinks are acceptable as long as a written procedure to meet sanitation requirements is developed;</text> </paragraph> <paragraph num="(i)"> <text>The hand sink shall be supplied with hot and cold water under pressure;</text> </paragraph> <paragraph num="(j)"> <text>The unit shall be supplied with adequate waste containers to hold dirty water until dumping is done; and</text> </paragraph> <paragraph num="(k)"> <text>The written procedure shall include the disposal of the dirty water.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".56" heading="Administrative Areas."> <paragraph num="A."> <text>Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Administrative Areas — New Construction.</text> <paragraph num="(1)"> <text>A nursing home shall provide a separate room or rooms for the administrator and administrative support staff. Sufficient areas shall be provided to accommodate all necessary office furniture, files, and other equipment and enable the safe storage of residents’ valuables.</text> </paragraph> <paragraph num="(2)"> <text>In new construction, separate locker rooms and a toilet facility shall be provided for male and female employees in each nursing home.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Administrative Areas — Existing Nursing Homes.</text> <paragraph num="(1)"> <text>The nursing home shall provide an administrative area that is suitable for conducting business or discussing problems privately with the resident’s representative.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall provide a sufficient number of lockers that can be locked securely for all employees working at any one time, and shall provide for the employee use of toilet facilities.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Lobby Area — New Nursing Home. A nursing home shall provide a lobby area that shall have:</text> <paragraph num="(1)"> <text>Public toilets for both sexes, either separate or unisex, located conveniently to this area;</text> </paragraph> <paragraph num="(2)"> <text>Access to telephone; and</text> </paragraph> <paragraph num="(3)"> <text>Drinking fountains or other drinking water dispensers that meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Employee Facilities — New Construction. In new construction, separate locker rooms and toilet facilities shall be provided for male and female employees in each facility.</text> </paragraph> <paragraph num="F."> <text>Employee Facilities — Existing Facilities. An existing nursing home shall:</text> <paragraph num="(1)"> <text>Have a sufficient number of lockers that can be locked securely for all employees working at any one time; and</text> </paragraph> <paragraph num="(2)"> <text>Provide for the employee use of toilet facilities at a convenient location.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".57" heading="Housekeeping Services, Pest Control, and Laundry."> <paragraph num="A."> <text>General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home.</text> </paragraph> <paragraph num="B."> <text>Staff. Sufficient housekeeping and maintenance personnel shall be employed to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner.</text> </paragraph> <paragraph num="C."> <text>Cleanliness and Maintenance.</text> <paragraph num="(1)"> <text>The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the primary consideration.</text> </paragraph> <paragraph num="(2)"> <text>All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a type to allow frequent and easy cleaning.</text> </paragraph> <paragraph num="(3)"> <text>The nursing home shall be kept free of unnecessary accumulations of personal possessions, boxes, trunks, suitcases, papers, unused furniture, bed clothing, linens, bric-a-brac, and similar items.</text> </paragraph> <paragraph num="(4)"> <text>Storage areas shall be:</text> <paragraph num="(a)"> <text>Kept clean and orderly; and</text> </paragraph> <paragraph num="(b)"> <text>Readily accessible for:</text> <paragraph num="(i)"> <text>Housekeeping;</text> </paragraph> <paragraph num="(ii)"> <text>Maintenance; and</text> </paragraph> <paragraph num="(iii)"> <text>Pest control servicing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>The grounds shall be kept clean, neat, attractive, and free of hazards.</text> </paragraph> <paragraph num="(6)"> <text>Pest Control. The nursing home shall:</text> <paragraph num="(a)"> <text>Be maintained free of insects and rodents by operation of an active pest-control program, either by use of maintenance personnel or by contract with a pest-control company;</text> </paragraph> <paragraph num="(b)"> <text>Use and store toxic and flammable insecticides and rodenticides with care;</text> </paragraph> <paragraph num="(c)"> <text>Ensure that usage of toxic and flammable insecticides and rodenticides conforms to the U.S. Environmental Protection Administration and Maryland Department of Agriculture requirements;</text> </paragraph> <paragraph num="(d)"> <text>Be protected to prevent the entry and harborage of rodents and insects;</text> </paragraph> <paragraph num="(e)"> <text>Install and effectively maintain:</text> <paragraph num="(i)"> <text>Screen doors that fit tightly when closed;</text> </paragraph> <paragraph num="(ii)"> <text>Easily adjusted closely fitted window screens;</text> </paragraph> <paragraph num="(iii)"> <text>Rat-proofing devices; or</text> </paragraph> <paragraph num="(iv)"> <text>Other approved deterrents; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Effectively protect all openings to the outside against the entry of insects by:</text> <paragraph num="(i)"> <text>Closed doors;</text> </paragraph> <paragraph num="(ii)"> <text>Closed windows; or</text> </paragraph> <paragraph num="(iii)"> <text>Other means.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Laundry Services.</text> <paragraph num="(a)"> <text>A nursing home shall provide laundry service, whether on-site or off-site.</text> </paragraph> <paragraph num="(b)"> <text>Laundry service shall be provided to meet the residents’ needs.</text> </paragraph> <paragraph num="(c)"> <text>All laundry shall be processed and handled in a manner that prevents the spread of infections. Staff working in laundry shall be given personal protective equipment, including:</text> <paragraph num="(i)"> <text>Disposable gloves;</text> </paragraph> <paragraph num="(ii)"> <text>Masks; and</text> </paragraph> <paragraph num="(iii)"> <text>Body coverings.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>All laundry shall be processed through the use of sufficiently hot water, chemical agents, or a combination of the both, to remove or destroy infectious biological materials.</text> </paragraph> <paragraph num="(e)"> <text>Clean and Soiled Areas.</text> <paragraph num="(i)"> <text>There shall be a physical separation between the clean and soiled areas.</text> </paragraph> <paragraph num="(ii)"> <text>The soiled area shall allow for sorting and washing soiled laundry.</text> </paragraph> <paragraph num="(iii)"> <text>The clean area shall allow for drying and folding of clean laundry.</text> </paragraph> <paragraph num="(iv)"> <text>All soiled areas within a laundry shall be connected to mechanically operated exhaust ventilation.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The system provided in laundries may not allow the spread of airborne contaminants to other parts of the nursing home that are occupied by residents, staff not working in the laundry, and the general public.</text> </paragraph> <paragraph num="(g)"> <text>The plumbing fixtures for all water supply connections to washing machines and the plumbing fixtures for all utility sinks shall have an integrated atmospheric vacuum breaker or other approved back-flow prevention devices.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".58" heading="Resident Care Management System."> <paragraph num="A."> <text>Each comprehensive care facility and extended care facility shall establish and maintain a resident care management system.</text> </paragraph> <paragraph num="B."> <text>The resident care management system shall consist of three related components:</text> <paragraph num="(1)"> <text>Resident status assessment and data gathering;</text> </paragraph> <paragraph num="(2)"> <text>Care planning; and</text> </paragraph> <paragraph num="(3)"> <text>Actions in response to care plan approaches.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".59" heading="Resident Status Assessment."> <paragraph num="A."> <text>A nursing home shall use the following forms and procedures for resident assessment as described in the CMS Manual System, Pub. 100-07 State Operations Provider Certification and in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual:</text> <paragraph num="(1)"> <text>The Minimum Data Set (MDS) version as determined by the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, in Transmittal No. 22, referenced in §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>MDS Care Area Assessment process; and</text> </paragraph> <paragraph num="(3)"> <text>Care plans.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nursing home shall complete all assessments in accordance with the provisions of 42 CFR §483.20, as amended.</text> </paragraph> <paragraph num="C."> <text>A nursing home certified for participation in Medicare or Medicaid shall complete and electronically submit the assessment to the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system. The assessment shall:</text> <paragraph num="(1)"> <text>Use a standard record layout format;</text> </paragraph> <paragraph num="(2)"> <text>Use a data dictionary as identified by the automated data processing requirements; and</text> </paragraph> <paragraph num="(3)"> <text>Pass standardized edits as defined by CMS and the State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A federally certified nursing home shall:</text> <paragraph num="(1)"> <text>Encode assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual; and</text> </paragraph> <paragraph num="(2)"> <text>Transmit assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual except as excluded in §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A nursing home licensed as a nursing home but not certified for participation in the Medicare or Medicaid Program shall comply with the CMS Manual System, Pub. 100-07 State Operations Provider Certification, and with RAI instructions in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, except that data may not be submitted electronically to the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".60" heading="Care Planning."> <paragraph num="A."> <text>An interdisciplinary team shall complete or revise as necessary a resident-specific care plan for each resident within 7 calendar days following completion of assessments, including:</text> <paragraph num="(1)"> <text>Admission assessment;</text> </paragraph> <paragraph num="(2)"> <text>Annual assessment;</text> </paragraph> <paragraph num="(3)"> <text>Quarterly assessment; and</text> </paragraph> <paragraph num="(4)"> <text>Significant change in the resident’s condition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Care Plan Meeting. The nursing home shall, with the resident’s consent:</text> <paragraph num="(1)"> <text>Give an interested and appropriate family member or resident’s representative 7 calendar days advance notice, in writing, of the location, date, and time of a care planning conference for a resident;</text> </paragraph> <paragraph num="(2)"> <text>Strive to accommodate the schedules of invited family members and resident’s representatives when scheduling care plan meetings; and</text> </paragraph> <paragraph num="(3)"> <text>Include an invitation for the family member or resident’s representative to attend the conference.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The nursing home shall hold the care planning conference not later than 7 calendar days after completing the assessment, but may hold the conference sooner if agreed to by the resident, a family member, or a resident’s representative.</text> </paragraph> <paragraph num="D."> <text>Organization of Care Plan.</text> <paragraph num="(1)"> <text>Resident’s problems and needs shall be identified, based upon the interdisciplinary assessment. The care plan shall address all of the resident’s special care requirements necessary to improve or maintain the resident’s status. The interdisciplinary team shall incorporate resident input into the care plan.</text> </paragraph> <paragraph num="(2)"> <text>The team shall establish goals for each problem or need identified, or a combination thereof. The goals shall be realistic, practical, and tailored to the resident’s needs. Goal outcomes shall be measurable in time or degree, or both.</text> </paragraph> <paragraph num="(3)"> <text>Approaches to accomplishing each goal shall be established. Approaches shall indicate the work to be done, who is to do it, and how frequently it is to be done.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disciplines shall update the care plans as the resident's assessment warrants, but not less than quarterly.</text> </paragraph> <paragraph num="F."> <text>Availability of Resident Care Plan. Resident care plans shall be readily available for use by all health care personnel.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".61" heading="Skin Record."> <paragraph num="A."> <text>The facility shall establish a skin care record documenting skin, hair, and nail condition on admission, if any abnormal conditions exist.</text> </paragraph> <paragraph num="B."> <text>The staff shall document progress of the condition or conditions weekly until the condition or conditions have healed.</text> </paragraph> <paragraph num="C."> <text>At any time that a skin condition persists for more than 7 days, staff shall add the condition to the skin record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".62" heading="Geriatric Nursing Assistant Training Program."> <paragraph num="A."> <text>Nursing Home Responsibilities.</text> <paragraph num="(1)"> <text>A nursing home shall conduct or arrange a geriatric nursing assistant training program for unlicensed personnel assigned to direct resident care duties. The Maryland Board of Nursing shall approve the geriatric nursing assistant training program curriculum.</text> </paragraph> <paragraph num="(2)"> <text>A nursing home may not employ an individual as a geriatric nursing assistant until the individual has successfully completed a competency evaluation approved by the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>A geriatric nursing assistant is deemed to satisfy the requirements of this chapter if that individual has successfully completed a training program approved by the State before July 1, 1990, or has been “grandfathered” under previous regulations.</text> </paragraph> <paragraph num="(4)"> <text>Other persons hired as geriatric nursing assistants shall complete an approved geriatric nursing assistant training program within 120 days of employment.</text> </paragraph> <paragraph num="(5)"> <text>The nursing home shall:</text> <paragraph num="(a)"> <text>Record the satisfactory completion of the program in each employee’s personnel record; and</text> </paragraph> <paragraph num="(b)"> <text>Give the employee a certificate signed by the program’s teacher or trainer as evidence of completion of the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Course Structure.</text> <paragraph num="(1)"> <text>The geriatric nursing assistant training program shall consist of 75 hours or more, and include at least 37.5 hours of classroom instruction and at least 37.5 hours of supervised clinical experience in long-term care.</text> </paragraph> <paragraph num="(2)"> <text>The course content shall adhere to the geriatric nursing assistant training program curriculum approved by the Maryland Board of Nursing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".63" heading="Paid Feeding Assistants."> <paragraph num="A."> <text>A facility may use a paid feeding assistant who has successfully completed a State-approved training course as described in §E of this regulation.</text> </paragraph> <paragraph num="B."> <text>Supervision.</text> <paragraph num="(1)"> <text>A paid feeding assistant shall work under the supervision of a licensed nurse.</text> </paragraph> <paragraph num="(2)"> <text>In an emergency, when the resident is fed in the resident's room, a paid feeding assistant shall use the resident call system to call a supervisory nurse for help.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A nursing home that uses a paid feeding assistant shall ensure that the paid feeding assistant feeds only residents who do not have complicated feeding conditions including, but not limited to:</text> <paragraph num="(1)"> <text>Difficulty swallowing;</text> </paragraph> <paragraph num="(2)"> <text>Choking;</text> </paragraph> <paragraph num="(3)"> <text>Recurrent lung aspiration; or</text> </paragraph> <paragraph num="(4)"> <text>Tube or parenteral intravenous feedings.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Protocol. The nursing home shall develop a protocol for selecting residents who are appropriate for feeding by a paid feeding assistant. The nursing home shall select eligible residents based on the:</text> <paragraph num="(1)"> <text>Charge nurse's current assessment of the resident;</text> </paragraph> <paragraph num="(2)"> <text>The resident's latest Minimum Data Set (MDS) assessment; and</text> </paragraph> <paragraph num="(3)"> <text>The resident's plan of care.</text> </paragraph> </paragraph> <paragraph num="E."> <text>State-Approved Training. A State-approved training course for paid feeding assistants shall consist of at least 8 hours of training that includes:</text> <paragraph num="(1)"> <text>Feeding techniques;</text> </paragraph> <paragraph num="(2)"> <text>Assistance with feeding and hydration;</text> </paragraph> <paragraph num="(3)"> <text>Communication and interpersonal skills;</text> </paragraph> <paragraph num="(4)"> <text>Appropriate responses to resident behavior;</text> </paragraph> <paragraph num="(5)"> <text>Safety and emergency procedures, including the Heimlich maneuver;</text> </paragraph> <paragraph num="(6)"> <text>Infection control;</text> </paragraph> <paragraph num="(7)"> <text>Resident rights;</text> </paragraph> <paragraph num="(8)"> <text>Recognizing changes in a resident's behavior that are inconsistent with the resident's normal behavior and the importance of reporting these changes to a supervisory nurse; and</text> </paragraph> <paragraph num="(9)"> <text>Successful completion of a two-part test that includes a:</text> <paragraph num="(a)"> <text>Written test with a passing score of 80 percent; and</text> </paragraph> <paragraph num="(b)"> <text>Demonstration of proper feeding skills performed on a resident while being observed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The feeding assistant training may be taught by a:</text> <paragraph num="(1)"> <text>Registered nurse and supplementary professional instructors;</text> </paragraph> <paragraph num="(2)"> <text>Licensed dietitian-nutritionist;</text> </paragraph> <paragraph num="(3)"> <text>Licensed physical therapist;</text> </paragraph> <paragraph num="(4)"> <text>Licensed speech therapist; or</text> </paragraph> <paragraph num="(5)"> <text>Licensed occupational therapist.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The facility shall maintain a record of all paid feeding assistants who have successfully completed a feeding assistance course.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".64" heading="Quality Assurance Program."> <paragraph num="A."> <text>A nursing home shall establish an effective quality assurance program that includes components described in this regulation and Regulation .65 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The nursing home shall appoint a qualified individual to manage quality assurance activities within the nursing facility.</text> </paragraph> <paragraph num="C."> <text>The nursing home shall establish a quality assurance committee that includes at least:</text> <paragraph num="(1)"> <text>The nursing home director of nursing;</text> </paragraph> <paragraph num="(2)"> <text>The nursing home administrator;</text> </paragraph> <paragraph num="(3)"> <text>A social worker;</text> </paragraph> <paragraph num="(4)"> <text>The nursing home medical director;</text> </paragraph> <paragraph num="(5)"> <text>A dietitian-nutritionist; and</text> </paragraph> <paragraph num="(6)"> <text>A geriatric nursing assistant at the nursing home.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Quality Assurance Committee. The quality assurance committee shall:</text> <paragraph num="(1)"> <text>Designate an individual to oversee committee activities;</text> </paragraph> <paragraph num="(2)"> <text>Meet monthly to carry out quality assurance activities;</text> </paragraph> <paragraph num="(3)"> <text>Help develop and approve the nursing home’s quality assurance plan;</text> </paragraph> <paragraph num="(4)"> <text>Submit the quality assurance plan to the Department’s Office of Health Care Quality at the time of initial application for licensure;</text> </paragraph> <paragraph num="(5)"> <text>Submit any changes to the quality assurance plan to the Office of Health Care Quality within 30 days of the changes;</text> </paragraph> <paragraph num="(6)"> <text>Review and approve the facility's quality assurance plan at least yearly; and</text> </paragraph> <paragraph num="(7)"> <text>Prepare monthly reports for the ombudsman, family council, and residents' council.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Quality Assurance Records. For the purposes of ensuring implementation and effectiveness of the quality assurance program, the facility shall make quality assurance records and documents available to the Office of Health Care Quality.</text> </paragraph> <paragraph num="F."> <text>Quality Assurance Committee — Non-members. Anyone not on the committee shall be informed of how to present and submit concerns to:</text> <paragraph num="(1)"> <text>The committee;</text> </paragraph> <paragraph num="(2)"> <text>A member of the resident council; or</text> </paragraph> <paragraph num="(3)"> <text>A member of the family council if one exists.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".65" heading="Quality Assurance Plan."> <paragraph num="A."> <text>The nursing home’s quality assurance committee shall develop and implement a quality assurance plan that includes procedures for:</text> <paragraph num="(1)"> <text>Concurrent review;</text> </paragraph> <paragraph num="(2)"> <text>Ongoing monitoring;</text> </paragraph> <paragraph num="(3)"> <text>Resident complaints;</text> </paragraph> <paragraph num="(4)"> <text>Accidents and incidents; and</text> </paragraph> <paragraph num="(5)"> <text>Abuse and neglect.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Review. The quality assurance plan shall include:</text> <paragraph num="(1)"> <text>The procedures for conducting concurrent review of each resident including:</text> <paragraph num="(a)"> <text>Criteria to determine any change in a resident's condition;</text> </paragraph> <paragraph num="(b)"> <text>A method to document the concurrent review; and</text> </paragraph> <paragraph num="(c)"> <text>Identification of the licensed nurse or nurses conducting the concurrent review;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The procedures to evaluate clinical data for any resident with a change in condition including at least:</text> <paragraph num="(a)"> <text>Medications;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory values;</text> </paragraph> <paragraph num="(c)"> <text>Intake and output;</text> </paragraph> <paragraph num="(d)"> <text>Skin breakdown;</text> </paragraph> <paragraph num="(e)"> <text>Noted weights;</text> </paragraph> <paragraph num="(f)"> <text>Appetite;</text> </paragraph> <paragraph num="(g)"> <text>Injuries resulting from accidents or incidents; and</text> </paragraph> <paragraph num="(h)"> <text>Any other relevant parameters that may affect the resident's physical or mental status;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Procedures to take action when there is a change in the resident’s condition, including:</text> <paragraph num="(a)"> <text>Communicating changes to the director of nursing or the resident’s attending physician; and</text> </paragraph> <paragraph num="(b)"> <text>Changing the resident’s plan of care as necessary; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Procedure for referring data to the quality assurance committee, when appropriate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Ongoing Monitoring. The quality assurance plan shall include:</text> <paragraph num="(1)"> <text>A description of the measurable criteria for ongoing monitoring of all aspects of resident care including:</text> <paragraph num="(a)"> <text>Medication administration;</text> </paragraph> <paragraph num="(b)"> <text>Prevention of pressure ulcers, dehydration, and malnutrition;</text> </paragraph> <paragraph num="(c)"> <text>Nutritional status and weight loss or weight gain;</text> </paragraph> <paragraph num="(d)"> <text>Accidents and injuries;</text> </paragraph> <paragraph num="(e)"> <text>Unexpected death; and</text> </paragraph> <paragraph num="(f)"> <text>Changes in physical or mental status;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The methodology for collecting data;</text> </paragraph> <paragraph num="(3)"> <text>The methodology for evaluating and analyzing data to determine trends and patterns;</text> </paragraph> <paragraph num="(4)"> <text>A description of the thresholds and performance parameters that represent acceptable care for the measured criteria;</text> </paragraph> <paragraph num="(5)"> <text>Time frames for referral to the quality assurance committee;</text> </paragraph> <paragraph num="(6)"> <text>A description of the plan for follow-up to determine effectiveness of the recommendations; and</text> </paragraph> <paragraph num="(7)"> <text>A description of how the quality assurance activities will be documented.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Resident Complaints. The quality assurance plan shall include:</text> <paragraph num="(1)"> <text>A description of a complaint process that effectively addresses resident and family concerns including:</text> <paragraph num="(a)"> <text>The designated person or persons and their phone numbers to receive complaints and concerns;</text> </paragraph> <paragraph num="(b)"> <text>The method to be used to acknowledge complaints received; and</text> </paragraph> <paragraph num="(c)"> <text>The time frames for investigating complaints, depending on the nature or seriousness of the complaint;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A description of a logging system that will be used including the:</text> <paragraph num="(a)"> <text>Name of the complainant;</text> </paragraph> <paragraph num="(b)"> <text>Date the complaint was received;</text> </paragraph> <paragraph num="(c)"> <text>Nature of the complaint; and</text> </paragraph> <paragraph num="(d)"> <text>Date that the complainant was notified of the disposition or resolution of the complaint; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The procedures for:</text> <paragraph num="(a)"> <text>Notifying residents of their right to file a complaint with the Office of Health Care Quality;</text> </paragraph> <paragraph num="(b)"> <text>Informing residents, families, or guardians of the complaint process upon admission; and</text> </paragraph> <paragraph num="(c)"> <text>Posting the complaint process or making it available without the need to request it.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Accidents and Injuries. The quality assurance plan shall include:</text> <paragraph num="(1)"> <text>A definition of accident and injury that is appropriate to the type of resident served by the nursing home;</text> </paragraph> <paragraph num="(2)"> <text>A description of the process for reporting accidents and injuries including:</text> <paragraph num="(a)"> <text>Who shall report incidents;</text> </paragraph> <paragraph num="(b)"> <text>The time frame for reporting incidents; and</text> </paragraph> <paragraph num="(c)"> <text>The procedure for reporting incidents;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A policy statement that ensures that incidents can be reported without fear of reprisal;</text> </paragraph> <paragraph num="(4)"> <text>A description of how internal investigations of accidents and injuries will be handled including:</text> <paragraph num="(a)"> <text>Assessment of any injury;</text> </paragraph> <paragraph num="(b)"> <text>Interview of the resident, staff, and any witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Review of any relevant records including the resident's medical records, discharge summary, hospital records, etc.; and</text> </paragraph> <paragraph num="(d)"> <text>Time frames for conducting the investigation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A description of the process for notifying a family or guardian about the incident;</text> </paragraph> <paragraph num="(6)"> <text>A description of the process for the ongoing evaluation of patterns and trends in accidents and injuries; and</text> </paragraph> <paragraph num="(7)"> <text>A description of how relevant information will be referred to the quality assurance committee.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Abuse and Neglect. The quality assurance plan shall include:</text> <paragraph num="(1)"> <text>The process for implementing COMAR 10.07.09.15 concerning abuse of residents;</text> </paragraph> <paragraph num="(2)"> <text>A description of the process for providing immediate notification to the family, guardian, or responsible party about the incident;</text> </paragraph> <paragraph num="(3)"> <text>A description of the process for the ongoing evaluation of validated incidents of abuse and neglect to determine patterns and trends; and</text> </paragraph> <paragraph num="(4)"> <text>A description of how relevant information will be referred to the quality assurance committee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".66" heading="Relocation of Residents."> <paragraph num="A."> <text>The facility shall develop and implement a written plan to provide for the smooth and orderly transfer of residents if the facility closes.</text> </paragraph> <paragraph num="B."> <text>The plan for relocation shall include:</text> <paragraph num="(1)"> <text>A description of how residents, families, or guardians will be notified and by whom;</text> </paragraph> <paragraph num="(2)"> <text>Sample letters and other documents that will be used during a closure;</text> </paragraph> <paragraph num="(3)"> <text>Procedures for notifying Medicaid and other payment sources;</text> </paragraph> <paragraph num="(4)"> <text>Procedures for notifying the Office of Health Care Quality; and</text> </paragraph> <paragraph num="(5)"> <text>A mechanism to ensure the safe and orderly transfer of residents that takes into account:</text> <paragraph num="(a)"> <text>Roommates, medical care, religious affiliation, geographical location and payer source;</text> </paragraph> <paragraph num="(b)"> <text>Proper assessment and identification of any special needs;</text> </paragraph> <paragraph num="(c)"> <text>Transfer of medical information and records; and</text> </paragraph> <paragraph num="(d)"> <text>Transfer of personal property.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".67" heading="Posting of Staffing."> <paragraph num="A."> <text>A nursing home shall post a notice on each floor or unit of the nursing home, for each shift, a notice that gives the ratio of licensed and unlicensed staff to residents.</text> </paragraph> <paragraph num="B."> <text>The posting on each floor shall include:</text> <paragraph num="(1)"> <text>Names of the staff members on duty and the room numbers of the residents to whom each is assigned;</text> </paragraph> <paragraph num="(2)"> <text>Name of the charge nurse or person who is in charge of the unit;</text> </paragraph> <paragraph num="(3)"> <text>If the person in charge is not a registered nurse, the name of the registered nurse responsible for the unit; and</text> </paragraph> <paragraph num="(4)"> <text>Name of the medicine aide or person responsible for medication administration.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The posting shall be on a form provided or approved by the Department.</text> </paragraph> <paragraph num="D."> <text>A record of the posting shall be retained for 1 year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".68" heading="Sanctions."> <paragraph num="A."> <text>If a deficiency exists, the Department, in addition to the sanctions set forth in this regulation and Regulations .67—.74 of this chapter, may:</text> <paragraph num="(1)"> <text>Restrict the number of residents the nursing facility may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Direct the licensee to correct the deficiencies in a specific manner or within a specific time frame, or both, to protect the health and welfare of residents;</text> </paragraph> <paragraph num="(4)"> <text>Enter into an agreement with the licensee establishing certain conditions for continued operation, including time limits for compliance; and</text> </paragraph> <paragraph num="(5)"> <text>In accordance with Health-General Article, §19-1405, Annotated Code of Maryland, appoint an independent State monitor who is qualified on the basis of education and experience to oversee correction of the deficiencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>State Monitor.</text> <paragraph num="(1)"> <text>The duties of the State monitor shall be specified in a written agreement between the Department and the State monitor and shall include but are not limited to:</text> <paragraph num="(a)"> <text>Conducting periodic on-site inspections to assess a nursing facility's compliance with State and federal regulations;</text> </paragraph> <paragraph num="(b)"> <text>Making recommendations to achieve compliance with State and federal regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Issuing written reports to the Department and the nursing home, detailing the findings of the on-site inspections and the status of requirements and recommendations for the nursing home to achieve compliance.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The State monitor shall function for a period of time specified by the Department. The facility may request rescission or modification of the duration of the State monitor's appointment at intervals of not less than 120 days from the date of appointment.</text> </paragraph> <paragraph num="(3)"> <text>The State monitor may not be an employee of the Department.</text> </paragraph> <paragraph num="(4)"> <text>The State monitor's salary shall be:</text> <paragraph num="(a)"> <text>Paid directly by the nursing facility; and</text> </paragraph> <paragraph num="(b)"> <text>At least equivalent to the prevailing salary paid by nursing facilities for an individual with similar education and experience.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may revoke the license as permitted by applicable law.</text> </paragraph> <paragraph num="D."> <text>A licensee that disagrees with the imposition of a sanction under §A(1) or (5) of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter. A licensee that disagrees with the imposition of a sanction under §A(2) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".69" heading="Mandated Staffing Pattern."> <paragraph num="A."> <text>When the Department determines that a deficiency or deficiencies exist, the Department shall notify the nursing facility of the deficiency or deficiencies and may either:</text> <paragraph num="(1)"> <text>Mandate a staffing pattern which specifies the number of personnel or personnel qualifications, or both; or</text> </paragraph> <paragraph num="(2)"> <text>Permit the facility the opportunity to correct the deficiencies by a specific date.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the facility does not correct the deficiency or deficiencies, the Department has the authority to specify the number of personnel or personnel qualifications, or both.</text> </paragraph> <paragraph num="C."> <text>The facility shall comply with the Department's mandated staffing pattern and notify the Department, in writing, when the staffing pattern has been implemented.</text> </paragraph> <paragraph num="D."> <text>A mandated staffing pattern shall be in effect for the period of time specified by the Department. A facility may request rescission or modification of the staffing pattern at intervals of not less than 60 days from the date of imposition of the staffing pattern.</text> </paragraph> <paragraph num="E."> <text>A facility has the right to appeal a mandated staffing pattern in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. However, the mandated staffing pattern shall be maintained during the pendency of the appeal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".70" heading="Civil Money Penalties — Imposition."> <paragraph num="A."> <text>A civil money penalty may be imposed when:</text> <paragraph num="(1)"> <text>A deficiency exists; or</text> </paragraph> <paragraph num="(2)"> <text>An ongoing pattern of deficiencies exist in a nursing facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(5)"> <text>A nursing facility's prior history of compliance in general and specifically with reference to the cited deficiencies; and</text> </paragraph> <paragraph num="(6)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the nursing facility of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Impose a per day civil money penalty until sustained compliance has been achieved;</text> </paragraph> <paragraph num="(2)"> <text>Permit the facility the opportunity to correct the deficiencies by a specific date; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a per instance civil money penalty for each instance of violation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When the Department permits a facility the opportunity to correct the deficiencies by a specific date, and the facility fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> <paragraph num="E."> <text>When a civil money penalty is imposed, the Department shall issue an order which includes the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order was based;</text> </paragraph> <paragraph num="(2)"> <text>Amount of civil money penalty to be imposed; and</text> </paragraph> <paragraph num="(3)"> <text>Manner in which the amount of civil money penalty was calculated.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An order issued pursuant to §E of this regulation is void unless issued within 60 days of the inspection or reinspection at which the deficiency or deficiencies are identified.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".71" heading="Civil Money Penalties — Amount of Penalty."> <paragraph num="A."> <text>A civil money penalty imposed under this chapter for potential for more than minimal harm deficiencies may not exceed:</text> <paragraph num="(1)"> <text>$10,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$1,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A civil money penalty imposed under this chapter for actual harm deficiencies may not exceed:</text> <paragraph num="(1)"> <text>$10,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$5,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A civil money penalty imposed under this chapter for a serious and immediate threat may not exceed:</text> <paragraph num="(1)"> <text>$10,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$10,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In setting the amount of a civil money penalty, the Department shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(3)"> <text>The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>Current federal guidelines for civil money penalties;</text> </paragraph> <paragraph num="(5)"> <text>Whether the amount of the proposed civil money penalty will jeopardize the financial ability of the nursing facility to continue operating as a nursing facility;</text> </paragraph> <paragraph num="(6)"> <text>A nursing facility's prior history of compliance; and</text> </paragraph> <paragraph num="(7)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".72" heading="Civil Money Penalties — Effective Date and Duration of Penalty."> <paragraph num="A."> <text>Per Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies upon which the civil money penalty is based first occurred.</text> </paragraph> <paragraph num="B."> <text>Per Day Civil Money Penalty.</text> <paragraph num="(1)"> <text>The daily civil money penalty starts to accrue as of the date of the visit that identifies the deficiency or deficiencies upon which the civil money penalty is based.</text> </paragraph> <paragraph num="(2)"> <text>The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies upon which the civil money penalty was based has been verified and the facility has maintained sustained compliance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".73" heading="Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account."> <paragraph num="A."> <text>A civil money penalty payment is due 15 calendar days after:</text> <paragraph num="(1)"> <text>The time period for requesting a hearing has expired and a request for hearing was not received; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt of a written request from the facility to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent provided the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Within 15 days of the request for an appeal by a nursing facility, the nursing facility shall deposit the amount of the civil money penalty in an interest-bearing escrow account. If a per day civil money penalty is in effect at the time the escrow account is established, the amount owed on that date shall be deposited into the escrow account. The nursing facility shall bear any cost associated with establishing the escrow account, and the account shall be titled in the name of the nursing facility and the Maryland Department of Health as joint owners.</text> </paragraph> <paragraph num="C."> <text>When the Secretary issues the final decision of the Department:</text> <paragraph num="(1)"> <text>If the decision upholds the imposition of the full civil money penalty, the escrow funds, in addition to the amount of any per day civil money penalty that has accrued after the initial deposit into the escrow account, shall be released to the Department within 15 days from the date of the decision;</text> </paragraph> <paragraph num="(2)"> <text>If the decision upholds the imposition of a civil money penalty, but reduces the amount of the civil money penalty, the amount due the Department shall be released to the Department with accrued interest within 15 days of the date of the decision and the balance will be released to the nursing facility within 15 days of the date of the decision; or</text> </paragraph> <paragraph num="(3)"> <text>If the decision reverses the imposition of the civil penalty, the escrow funds shall be released to the nursing facility with accrued interest within 15 days of the decision.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a facility does not release or pay the civil money penalty to the Department after the Secretary has issued a final decision upholding the civil money penalty and after notice to the facility, the State may deduct the amount of the civil money penalty from any sum that is then or later owed by the State to the facility, pursuant to State Finance and Procurement Article, §7-222, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".74" heading="Civil Money Penalties — Hearings."> <paragraph num="A."> <text>A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary has the burden of proof with respect to the imposition of civil money penalties.</text> </paragraph> <paragraph num="C."> <text>The Office of Administrative Hearings shall render a decision within 10 working days of the hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".75" heading="Criminal Penalties."> <paragraph num="A."> <text>A person maintaining or operating a nursing home without a license is guilty of a misdemeanor, and, on conviction, is liable for a fine of not more than $1,000 for the first offense and not more than $10,000 for each subsequent conviction in accordance with Health-General Article, §19-358, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Each day that the nursing home continues to operate without a license after the first conviction is a subsequent offense and may subject the operator to further criminal prosecution.</text> </paragraph> <paragraph num="C."> <text>A person maintaining and operating a nursing home that is in violation of this chapter is guilty of a misdemeanor, and, on conviction, shall be fined not more than $1,000 under the authority of Health-General Article, §19-359, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>Each day that the nursing home operates after the first conviction, without correction of the cited violation, is considered a subsequent offense and may subject the operator to further prosecution.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".76" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-405(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the nursing facility:</text> <paragraph num="(1)"> <text>Informing the nursing facility of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the nursing facility of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is suspended by emergency action:</text> <paragraph num="(1)"> <text>The nursing facility shall immediately return the license to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall notify the residents or representatives of the residents of the suspension and make every reasonable effort to assist them in making arrangements for transfer to other appropriate living arrangements.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In the event of an emergency suspension, the Department may assist in the relocation of residents.</text> </paragraph> <paragraph num="F."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter.</text> </paragraph> <paragraph num="G."> <text>The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .59 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="H."> <text>If the Secretary's final decision does not uphold the emergency suspension, the nursing facility may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".77" heading="Denial or Revocation of License."> <paragraph num="A."> <text>Denial or Revocation of License. The Secretary, for cause shown, may notify the nursing facility of the decision to revoke or deny the nursing facility's license. The denial or revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Department shall notify the nursing facility in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the denial or revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the denial or revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the denial or revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the nursing facility is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the nursing facility shall stop providing services on the effective date of the denial or revocation if the nursing facility does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the denial or revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the nursing facility is required to surrender its license to the Department if the denial or revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensee shall notify the residents or residents' representatives of any final denial or revocation and make every reasonable effort to assist them in making other living arrangements. The Department may assist in the relocation of residents.</text> </paragraph> <paragraph num="D."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".78" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as provided in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".79" heading="Health Care Quality Account."> <paragraph num="A."> <text>The Department shall establish a health care quality account in the Department.</text> </paragraph> <paragraph num="B."> <text>The health care quality account shall be funded by civil money penalties paid by nursing homes.</text> </paragraph> <paragraph num="C."> <text>The Department shall use funds from the health care quality account to improve the quality of care in nursing facilities.</text> </paragraph> <paragraph num="D."> <text>Expenditure of funds may include, but are not limited to the following:</text> <paragraph num="(1)"> <text>Funding for the establishment and operation of a demonstration project;</text> </paragraph> <paragraph num="(2)"> <text>A grant award;</text> </paragraph> <paragraph num="(3)"> <text>Relocation of residents in crisis situations;</text> </paragraph> <paragraph num="(4)"> <text>Provision of educational programs to nursing facilities, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and</text> </paragraph> <paragraph num="(5)"> <text>Any other purpose that will directly improve quality of care.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Suggestions for the use of funds may be submitted to the Department from:</text> <paragraph num="(1)"> <text>Members of the public;</text> </paragraph> <paragraph num="(2)"> <text>Advocacy organizations;</text> </paragraph> <paragraph num="(3)"> <text>Government agencies;</text> </paragraph> <paragraph num="(4)"> <text>Professional organizations including trade associations;</text> </paragraph> <paragraph num="(5)"> <text>Nursing homes; and</text> </paragraph> <paragraph num="(6)"> <text>Nursing home associations.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Decision on Expenditure of Funds.</text> <paragraph num="(1)"> <text>The Department, in its sole discretion, shall decide how to spend funds from the health care quality account.</text> </paragraph> <paragraph num="(2)"> <text>The Department's decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore is not subject to appeal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".80" heading="Financial Disclosure."> <paragraph num="A."> <text>A licensee shall have financial resources in accordance with this regulation in order to:</text> <paragraph num="(1)"> <text>Satisfy obligations; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure at all times the delivery of essential care and services, such as nursing, dietary services, or utilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall notify the Secretary of significant adverse changes in financial condition which reasonably could be anticipated to adversely affect the delivery of essential care and services. These adverse changes include, but are not limited to, the following situations:</text> <paragraph num="(1)"> <text>The facility fails to maintain the facility's utilities or a quantity of supplies, including nursing, dietary, pharmaceutical, or other care and service supplies, sufficient to meet the needs of the residents;</text> </paragraph> <paragraph num="(2)"> <text>The facility is unable to meet its employee payroll or benefits obligations;</text> </paragraph> <paragraph num="(3)"> <text>The license holder or entity legally authorized to act on behalf of the license holder receives notice that a judgment or tax lien of at least $5,000 has been filed, recorded, or levied against the facility or any of the assets of the facility or the license holder and the judgment or tax lien is not satisfied, or an appropriate extension has not been obtained, within 30 days after receipt of the notice;</text> </paragraph> <paragraph num="(4)"> <text>A financial institution refuses to honor facility-operation-related checks or other financial instruments issued by the license holder or entity legally authorized to act on behalf of the license holder, and:</text> <paragraph num="(a)"> <text>The cumulative amount of the checks or financial instruments is $5,000 or more; and</text> </paragraph> <paragraph num="(b)"> <text>The checks or financial instruments are not honored or replaced to the satisfaction of the holders of the instruments within 10 working days after the holders have notified the license holder, operator, administrator, manager, or the person authorized to issue the instrument of the dishonored items;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The license holder, or entity legally authorized to act on behalf of the license holder fails to make timely payments of any facility-related tax of at least $1,000, and fails to satisfy the tax within 30 working days after the date the tax becomes delinquent;</text> </paragraph> <paragraph num="(6)"> <text>The license holder, owner of 25 percent of the license holder's assets, or facility management company files a voluntary bankruptcy petition, or a creditor files an involuntary bankruptcy petition against the facility management company, license holder, or owner of 25 percent or greater of the license holder's assets;</text> </paragraph> <paragraph num="(7)"> <text>A court appoints a bankruptcy trustee for the facility;</text> </paragraph> <paragraph num="(8)"> <text>A person seeking appointment of a receiver for the facility files a petition for the appointment of a receiver for the facility in any jurisdiction;</text> </paragraph> <paragraph num="(9)"> <text>The license holder, or person legally authorized to act on behalf of the license holder is unable to meet conditions of a facility-operation-related loan or material debt covenant unless the loan or material debt covenant has been waived or cured, and that inability has led to a recall by the issuing entity; or</text> </paragraph> <paragraph num="(10)"> <text>The license holder, or entity legally authorized to act on behalf of the license holder, is delinquent on more than $5,000 of facility-related contractual obligations or vendor contracts that affect essential care and services for residents and has not cured the delinquency within 10 working days after receipt of notice from the creditor or creditors to pay the debt.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The license holder shall notify the Secretary in writing of a significant adverse change in its financial condition as required by §B of this regulation within 72 hours after the license holder becomes aware of, or reasonably should have become aware of, the change in its financial condition.</text> </paragraph> <paragraph num="D."> <text>The license holder's notice required by §B of this regulation shall include a description of:</text> <paragraph num="(1)"> <text>The specific significant adverse change in financial condition;</text> </paragraph> <paragraph num="(2)"> <text>How the significant adverse change in financial condition affects or may affect the license holder's ability to deliver essential care and services; and</text> </paragraph> <paragraph num="(3)"> <text>The actions the license holder has taken to address the significant adverse change in financial condition.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The license holder shall fax, email, or hand-deliver the notice required in §B of this regulation to the Department's Office of Health Care Quality, and the notice shall be kept on file with a copy of the delivery confirmation.</text> </paragraph> <paragraph num="F."> <text>The license holder shall provide any other information, unless prohibited under applicable laws, requested by the Office of Health Care Quality to substantiate continued compliance with the requirements of this regulation within 30 days after the request. Failure to comply with the requirements of this regulation may result in the Secretary imposing one or more sanctions, as appropriate, from Regulations .51—.58 of this chapter against the facility.</text> </paragraph> <paragraph num="G."> <text>The information submitted pursuant to §D of this regulation is confidential and may not be disclosed without the consent of the licensee.</text> </paragraph> <paragraph num="H."> <text>Unless disclosure of the information is otherwise prohibited by applicable law, the provisions of §G of this regulation do not apply to:</text> <paragraph num="(1)"> <text>The holder of a license that has been suspended or revoked; or</text> </paragraph> <paragraph num="(2)"> <text>The use of information in:</text> <paragraph num="(a)"> <text>An administrative proceeding initiated by the Department; or</text> </paragraph> <paragraph num="(b)"> <text>A judicial proceeding.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-308, 19-308.1, 19-323, and 19-1401 et seq.;Public Safety Article, §14-110.1; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 30, 1978 (5:13 Md. R. 1053)</annotation> <annotation type="History" subtype="Administrative History">This chapter is a compilation and revision of prior regulations contained in COMAR 10.07.02, Nursing Homes—Extended Care, and COMAR 10.07.05, Intermediate Care Facilities—Long-term Care (Type A). COMAR 10.07.02 was effective January 1, 1967; amended effective March 27, 1973 and April 16, 1975 (2:8 Md. R. 565). COMAR 10.07.05 was effective July 1, 1969 and amended effective March 27, 1973.</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 7, 1991 (17:26 Md. R. 2975); June 22, 1992 (19:12 Md. R. 1134); January 17, 1994 (21:1 Md. R. 33); August 15, 1994 (21:16 Md. R. 1383); June 30, 1997 (24:13 Md. R. 931); June 1, 1998 (25:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); amended permanently effective May 14, 2001 (28:9 Md. R. 885)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 16, 2002 (29:18 Md. R. 1442); March 3, 2003 (30:4 Md. R. 316); September 13, 2004 (31:18 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01I-1, L-1, O-1, GG-1 adopted effective January 13, 1986 (13:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01GG-1, KK-1 adopted effective August 3, 1981 (8:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01II-1 adopted effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective June 1, 1998 (25:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 14, 1988 (15:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective May 10, 1993 (20:9 Md. R. 778)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 24, 2009 (36:17 Md. R. 1312)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective April 8, 1996 (23:7 Md. R. 551)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G adopted effective September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 10, 1993 (20:9 Md. R. 778); August 27, 2007 (34:17 Md. R. 1507); August 24, 2009 (36:17 Md. R. 1312); August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 24, 1982 (9:10 Md. R. 1021); June 22, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 1, 1994 (21:15 Md. R. 1304)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective May 10, 1993 (20:9 Md. R. 778)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 7, 1992 (19:24 Md. R. 2125)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 1, 2016 (43:15 Md. R. 864)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective January 25, 1980 (7:2 Md. R. 115)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 26, 1987 (14:2 Md. R. 128); May 20, 1996 (23:10 Md. R. 731); August 24, 2009 (36:17 Md. R. 1312)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective August 3, 1981 (8:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective May 24, 1982 (9:10 Md. R. 1021); January 26, 1987 (14:2 Md. R. 128); March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1 adopted effective January 1, 2007 (33:26 Md. R. 1996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 22, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B, D amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, E amended effective January 13, 1986 (13:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-1 adopted effective September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective November 8, 1982 (9:22 Md. R. 2196); January 13, 1986 (13:1 Md. R. 16); January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B-1 adopted effective August 3, 1981 (8:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C, D amended effective August 24, 2009 (36:17 Md. R. 1312)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 26, 1987 (14:2 Md. R. 128); June 30, 1997 (24:13 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective November 8, 1982 (9:22 Md. R. 2196)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10H amended effective May 24, 1982 (9:10 Md. R. 1021)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed and new Regulation .10 adopted effective August 6, 2001 (28:15 Md. R. 1396)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11O amended effective November 8, 1982 (9:22 Md. R. 2196)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and new Regulation .11 adopted effective August 6, 2001 (28:15 Md. R. 1396)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 adopted effective August 6, 2001 (28:15 Md. R. 1396)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-2 adopted effective August 6, 2001 (28:15 Md. R. 1396)</annotation> <annotation type="History" subtype="Administrative History">Regulations .12, .13, .18—.21 amended effective January 13, 1986 (13:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-1 adopted effective August 15, 1994 (21:16 Md. R. 1383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-2 adopted effective August 15, 1994 (21:16 Md. R. 1383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective January 26, 1987 (14:2 Md. R. 128); September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective March 16, 1992 (19:5 Md. R. 577); June 5, 1995 (22:11 Md. R. 820)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A, B amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective June 1, 1998 (25:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 repealed and new Regulation .21 adopted effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21E amended effective November 8, 1982 (9:22 Md. R. 2196)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21-1 adopted effective January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21-1 repealed and new Regulation .21-1 adopted effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21-2 adopted effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21-3 adopted effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21-4 adopted effective January 6, 2005 (31:26 Md. R. 1862)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22B amended effective August 3, 1981 (8:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 repealed and new Regulation .24 adopted effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26F amended and .26G—H repealed effective January 17, 1983 (10:1 Md. R. 28)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26EE amended effective October 25, 1982 (9:21 Md. R. 2106); September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A, B amended effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective January 26, 1987 (14:2 Md. R. 128); January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28C amended effective January 14, 1988 (15:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31A amended effective September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32F amended effective January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32G amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33E amended effective January 26, 1987 (14:2 Md. R. 128)</annotation> <annotation type="History" subtype="Administrative History">Regulations .35—.41 adopted effective January 13, 1986 (13:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35 amended effective December 16, 1996 (23:25 Md. R. 1785)</annotation> <annotation type="History" subtype="Administrative History">Regulation .36 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .36C amended effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .37 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .38 amended effective December 16, 1996 (23:25 Md. R. 1785)</annotation> <annotation type="History" subtype="Administrative History">Regulation .39A and B amended effective October 1, 1990 (17:19 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .39C and D repealed effective October 1, 1990 (17:19 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .39G amended effective June 30, 1986 (13:13 Md. R. 1491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .40A amended effective June 30, 1986 (13:13 Md. R. 1491)</annotation> <annotation type="History" subtype="Administrative History">Regulations .40 and .41 recodified to Regulations .43 and .44, respectively, Appendix recodified as Regulation .40 and amended, and new Regulations .41 and .42 adopted effective October 1, 1990 (17:19 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41 repealed and new Regulation .41 adopted effective September 13, 2004 (31:18 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41A amended effective August 1, 1994 (21:15 Md. R. 1304)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41D amended effective June 30, 1986 (13:13 Md. R. 1491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .43C adopted effective October 1, 1990 (17:19 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulations .45—.51 adopted effective January 7, 1991 (17:26 Md. R. 2975)</annotation> <annotation type="History" subtype="Administrative History">Regulations .45—.51 repealed as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); repealed permanently effective May 14, 2001 (28:9 Md. R. 885)</annotation> <annotation type="History" subtype="Administrative History">Regulations .45—.60 adopted as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); adopted permanently effective May 14, 2001 (28:9 Md. R. 885)</annotation> <annotation type="History" subtype="Administrative History">Regulation .49D amended effective September 16, 2002 (29:18 Md. R. 1442)</annotation> <annotation type="History" subtype="Administrative History">Regulation .54D adopted effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .61 adopted effective August 24, 2009 (36:17 Md. R. 1312)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 17, 2019 (46:12 Md. R. 536)</annotation> </annotations> </chapter> <chapter num="03" heading="Health Care Staff Agencies"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>The purpose of this chapter is to set minimum standards for licensure of health care staff agencies providing services in Maryland.</text> </paragraph> <paragraph num="B."> <text>The regulations of this chapter do not preclude a health care staff agency from operating with independent contractors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abuse.</text> <paragraph num="(a)"> <text>“Abuse” means:</text> <paragraph num="(i)"> <text>The nontherapeutic infliction upon a resident of physical pain or injury; or</text> </paragraph> <paragraph num="(ii)"> <text>A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Abuse” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another health care professional practicing within the scope of the physician's or health care professional's license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Agency” means a health care staff agency.</text> </paragraph> <paragraph num="(3)"> <text>Allied Health Care Field.</text> <paragraph num="(a)"> <text>“Allied health care field” means a healthcare profession subject to licensure under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Allied health care field” does not include the healthcare profession of physician assistant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Board” means a health occupation licensing board authorized to license, certify, and discipline a health care practitioner in accordance with the Health Occupations Article.</text> </paragraph> <paragraph num="(5)"> <text>“Client facility” means a health care facility that contracts with a health care staff agency for the referral of health care practitioners.</text> </paragraph> <paragraph num="(6)"> <text>“Deficiency” means any failure of the health care staff agency to meet the requirements of Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland, or any rule or regulation that the Secretary adopts under that subtitle.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>Health Care Practitioner.</text> <paragraph num="(a)"> <text>Except as provided in §B(9)(b) of this regulation, “health care practitioner” means any individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, who practices in an allied health care field.</text> </paragraph> <paragraph num="(b)"> <text>“Health care practitioner” does not include:</text> <paragraph num="(i)"> <text>An acupuncturist;</text> </paragraph> <paragraph num="(ii)"> <text>A dentist;</text> </paragraph> <paragraph num="(iii)"> <text>A nurse anesthetist;</text> </paragraph> <paragraph num="(iv)"> <text>A nurse midwife;</text> </paragraph> <paragraph num="(v)"> <text>A nurse practitioner;</text> </paragraph> <paragraph num="(vi)"> <text>A pharmacist;</text> </paragraph> <paragraph num="(vii)"> <text>A physician; or</text> </paragraph> <paragraph num="(viii)"> <text>A podiatrist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Initially providing or referring” means the first time a health care staff agency provides or refers a particular health care practitioner to a health care facility.</text> </paragraph> <paragraph num="(11)"> <text>“Licensee” means the person, association, partnership, corporation, limited-liability company, or other entity to which a license is issued.</text> </paragraph> <paragraph num="(12)"> <text>“Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.</text> </paragraph> <paragraph num="(13)"> <text>Health Care Staff Agency.</text> <paragraph num="(a)"> <text>“Health care staff agency” means any person, firm, corporation, partnership, or other business entity engaged in the business of referring health care practitioners as employees or independent contractors to render temporary health care services at a health care facility in the State.</text> </paragraph> <paragraph num="(b)"> <text>“Health care staff agency” does not include:</text> <paragraph num="(i)"> <text>A health care staff agency operated by a health care facility or its affiliates solely for the purpose of procuring, furnishing, or referring temporary or permanent health care practitioners for employment at that health care facility or its affiliates;</text> </paragraph> <paragraph num="(ii)"> <text>A home health agency regulated under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(iii)"> <text>Any health care practitioner procuring, furnishing, or referring their own services to a health care facility without the direct or indirect assistance of a health care staff agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Office” means the Office of Health Care Quality in the Department.</text> </paragraph> <paragraph num="(15)"> <text>“Responsible party” means the individual at a health care staff agency who controls the day-to-day operation of the health care staff agency.</text> </paragraph> <paragraph num="(16)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person, firm, corporation, partnership, or other business entity may not maintain or operate a health care staff agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter.</text> </paragraph> <paragraph num="B."> <text>An agency shall post its license conspicuously onsite so that it is clearly visible to the general public.</text> </paragraph> <paragraph num="C."> <text>An out-of-State agency providing services in this State shall have a current Maryland license conspicuously posted at the:</text> <paragraph num="(1)"> <text>Office in this State where the agency conducts its day-to-day operations, if the agency operates an in-State office; or</text> </paragraph> <paragraph num="(2)"> <text>Agency's records repository that is located in this State, if the agency utilizes a records repository.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Restrictions of License."> <paragraph num="A."> <text>A person operating an agency may not use the term “health care staff agency” in its advertising without first obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>A license is valid only in the name of the licensee to whom the license is issued and is not subject to sale, assignment, or other transfer.</text> </paragraph> <paragraph num="C."> <text>If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensing Procedure."> <paragraph num="A."> <text>Application for Licensure.</text> <paragraph num="(1)"> <text>A person desiring to refer a health care practitioner to a health care facility to render temporary health care services in this State shall file an application with the Secretary, on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>The application for licensure shall contain the agency's business name, address, telephone number, and responsible party.</text> </paragraph> <paragraph num="(3)"> <text>Along with the application, the applicant shall submit a copy of the agency’s policies and procedures as specified in Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Requirements.</text> <paragraph num="(1)"> <text>The applicant shall:</text> <paragraph num="(a)"> <text>Demonstrate compliance with all applicable federal, State, and local laws and regulations; and</text> </paragraph> <paragraph num="(b)"> <text>Submit all documentation requested by the Department that is relevant to the applicant's ability to operate an agency in compliance with this chapter, including documentation of any:</text> <paragraph num="(i)"> <text>Past or current operation of a health-related facility or an agency;</text> </paragraph> <paragraph num="(ii)"> <text>Prior denial, suspension, or revocation of a license of certification to provide care to third parties; and</text> </paragraph> <paragraph num="(iii)"> <text>Felony conviction of the applicant or anyone with direct or indirect ownership interest in the agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may require an applicant to submit information to demonstrate the applicant's financial ability to operate an agency in compliance with this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Duration of License. An agency's annual license shall expire on the annual anniversary of the date the license was originally issued unless the license is renewed for a 1-year term.</text> </paragraph> <paragraph num="D."> <text>License Renewal.</text> <paragraph num="(1)"> <text>At least 1 month before the current license expires, the Office shall send to the agency, by first-class mail to the last known address of the agency, a renewal notice that states:</text> <paragraph num="(a)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(b)"> <text>The date by which the renewal application shall be received by the Office for the renewal to be issued and mailed before the license expires; and</text> </paragraph> <paragraph num="(c)"> <text>That no renewal fee is required.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before a license expires, the agency may renew its license for an additional term by submitting a renewal application on a written or electronic form provided by the Secretary, if the agency:</text> <paragraph num="(a)"> <text>Otherwise is entitled to be licensed; and</text> </paragraph> <paragraph num="(b)"> <text>Provides updates, if any, to the agency's policies and procedures as specified in Regulation .09 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failure to Renew License. When an agency fails to renew its license, the agency shall:</text> <paragraph num="(a)"> <text>Immediately stop referring personnel to health care facilities; and</text> </paragraph> <paragraph num="(b)"> <text>Notify health care facilities where personnel are currently referred that the agency no longer has a valid operating license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application unconditionally;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or</text> </paragraph> <paragraph num="(3)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Nursing Staff Agency Licensees.</text> <paragraph num="(1)"> <text>Effective September 15, 2014, a person holding a nursing staff agency license who is in good standing and refers only nursing personnel shall be deemed to meet the requirements for issuance of a health care staff agency license.</text> </paragraph> <paragraph num="(2)"> <text>A person holding a nursing staff agency license who wishes to expand their referrals to other health care practitioners in addition to nursing personnel shall first obtain a new health care staff agency license.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Rights of Applicant if License is Revoked or Denied.</text> <paragraph num="(1)"> <text>Denial of License. The Secretary shall inform the applicant of the reasons for refusal to issue a license.</text> </paragraph> <paragraph num="(2)"> <text>Revocation of License. The Secretary may, for cause shown, revoke or refuse to reissue any license.</text> </paragraph> <paragraph num="(3)"> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .17 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Changes to Licensure Information."> <paragraph num="A."> <text>A licensee shall notify the Department of any change in agency ownership, name, or address within 30 calendar days of the change.</text> </paragraph> <paragraph num="B."> <text>Any change in agency ownership, name, or address requires the issuance of a new license. If the sale, transfer, assignment, or lease of an agency causes a change in the person or persons who control or operate the agency, the agency shall be considered a “new agency” and the new owner shall comply with all regulations of this chapter when applying for a new license.</text> </paragraph> <paragraph num="C."> <text>If the licensee fails to notify the Office of the changes in §A of this regulation, the Office may impose a fine of $100.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspections by the Department."> <paragraph num="A."> <text>The Department or its designee may conduct announced or unannounced licensure or complaint inspection visits to the agency's office or records repository, if utilized by an out-of-State agency, to ensure compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The agency's office or records repository, if utilized by an out-of-State agency, shall be available during normal business hours for announced or unannounced inspections by the Department or its designee.</text> </paragraph> <paragraph num="C."> <text>An agency with offices out-of-State shall comply with the regulations of this chapter and shall reimburse the Department for reasonable travel expenses incurred in conducting out-of-State inspections.</text> </paragraph> <paragraph num="D."> <text>An agency shall maintain records to support compliance with the regulations of this chapter. The responsible party of the agency shall provide all records requested by the Office not later than 24 hours after the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Administration."> <paragraph num="A."> <text>The agency shall develop, document, and implement policies and procedures.</text> </paragraph> <paragraph num="B."> <text>Policies and procedures shall include, but are not limited to:</text> <paragraph num="(1)"> <text>Selecting and verifying the credentials of a health care practitioner referred by the agency;</text> </paragraph> <paragraph num="(2)"> <text>Validating the experience of a health care practitioner prior to referral by the agency;</text> </paragraph> <paragraph num="(3)"> <text>Tracking and acting on serious or life-threatening complaints received by a client, facility, or the client facility's agent;</text> </paragraph> <paragraph num="(4)"> <text>Reporting of an action or condition performed by a health care practitioner as required under Regulation .09C of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Verifying the following:</text> <paragraph num="(a)"> <text>A health care practitioner referred by the agency is of satisfactory health status and has received the necessary testing and immunization as required or requested by the client facility;</text> </paragraph> <paragraph num="(b)"> <text>Drug screening of a health care practitioner is performed before referral by the agency, if the client facility requires drug screening for facility employees;</text> </paragraph> <paragraph num="(c)"> <text>Drug testing of a health care practitioner referred by the agency is performed, if there is probable cause to perform a drug test or if a client facility requests a drug test;</text> </paragraph> <paragraph num="(d)"> <text>Criminal background checks of a health care practitioner are performed before referral by the agency, if the client facility requires criminal background checks for facility employees;</text> </paragraph> <paragraph num="(e)"> <text>The references of a health care practitioner referred by the agency;</text> </paragraph> <paragraph num="(f)"> <text>A health care practitioner referred by the agency has I-9 status that permits them to legally work in the United States; and</text> </paragraph> <paragraph num="(g)"> <text>A health care practitioner has active licensure or certification with the Board; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Investigating a complaint or grievance presented to an agency by the client facility, an individual receiving services, a representative of the individual receiving services, or any concerned individual that includes a:</text> <paragraph num="(a)"> <text>Description of how and to whom to file a complaint within the agency;</text> </paragraph> <paragraph num="(b)"> <text>Description of how and to whom to file a complaint with the Office;</text> </paragraph> <paragraph num="(c)"> <text>Commitment to conduct a thorough investigation into any allegation against individuals referred by the agency; and</text> </paragraph> <paragraph num="(d)"> <text>Mechanism for making completed investigation reports available to the Department immediately upon request during inspections.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Referral and Reporting Health Care Practitioners."> <paragraph num="A."> <text>An agency may not knowingly provide or refer a heath care practitioner to render temporary services who is not authorized under Health Occupations Article, Annotated Code of Maryland, to practice their profession in Maryland.</text> </paragraph> <paragraph num="B."> <text>An agency and client facility shall ensure that the scope of practice of the referred health care practitioner is consistent with Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>If an agency is aware of an action or inaction by a health care practitioner who is provided or referred by the agency that may be grounds for action under Health Occupations Article, Annotated Code of Maryland, the agency shall report the action or condition to the appropriate Board and the Office immediately when the action or condition is known by the agency.</text> </paragraph> <paragraph num="D."> <text>An individual shall have immunity from liability described in the Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report as required under §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>Personnel Qualifications and Duties.</text> <paragraph num="(1)"> <text>The agency shall maintain the following from client facilities:</text> <paragraph num="(a)"> <text>Job descriptions for referred individuals; and</text> </paragraph> <paragraph num="(b)"> <text>A documented procedure for the agency and client facility to determine that an individual's qualifications are consistent with the assignments to which the individual is being referred.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agency shall maintain documentation indicating that individuals providing services in any health care facility within the State have been educated by the agency or the facility about:</text> <paragraph num="(a)"> <text>The facility's policies and procedures related to the individuals' scope of practice and responsibilities in the referred assignment; and</text> </paragraph> <paragraph num="(b)"> <text>The individuals' obligations under Maryland law to report abuse and neglect.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An agency shall attest on a form developed by the Department that the agency is in compliance with the federal:</text> <paragraph num="(a)"> <text>Civil Rights Act of 1964;</text> </paragraph> <paragraph num="(b)"> <text>Rehabilitation Act of 1973;</text> </paragraph> <paragraph num="(c)"> <text>Americans with Disabilities Act of 1990; and</text> </paragraph> <paragraph num="(d)"> <text>Drug Free Workplace Act of 1988, if applicable.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Civil Money Penalties — Imposition."> <paragraph num="A."> <text>The Department may impose a civil money penalty if a deficiency exists.</text> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiencies are part of a pattern;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the residents of the client facility caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of the agency to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(5)"> <text>An agency's prior history of compliance in general and specifically with reference to the cited deficiencies; and</text> </paragraph> <paragraph num="(6)"> <text>Other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department determines that a deficiency or a pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Impose a per-day civil money penalty until compliance has been achieved;</text> </paragraph> <paragraph num="(2)"> <text>Permit the agency the opportunity to correct the deficiencies by a specific date; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a per-instance civil money penalty for each deficiency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department permits an agency the opportunity to correct the deficiencies by a specific date and the agency fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and compliance has been maintained.</text> </paragraph> <paragraph num="E."> <text>When a civil money penalty is imposed, the Department shall issue an order that includes the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order was based; and</text> </paragraph> <paragraph num="(2)"> <text>Amount of civil money penalty to be imposed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Civil Money Penalties — Amount of Penalty."> <paragraph num="A."> <text>A civil money penalty imposed under this chapter for a first offense may not exceed:</text> <paragraph num="(1)"> <text>$2,500 for each instance of violation; or</text> </paragraph> <paragraph num="(2)"> <text>$2,500 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A civil money penalty imposed under this chapter for a second offense may not exceed:</text> <paragraph num="(1)"> <text>$5,000 for each instance of violation; or</text> </paragraph> <paragraph num="(2)"> <text>$5,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A civil money penalty imposed under this chapter for a third or subsequent offense may not exceed:</text> <paragraph num="(1)"> <text>$10,000 for each instance of violation; or</text> </paragraph> <paragraph num="(2)"> <text>$10,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Civil Money Penalties — Effective Date and Duration of Penalty."> <paragraph num="A."> <text>Per-Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies on which the civil money penalty is based first occurred.</text> </paragraph> <paragraph num="B."> <text>Per-Day Civil Money Penalty.</text> <paragraph num="(1)"> <text>The daily civil money penalty starts to accrue as of the date of the inspection, survey, or interview by the Department that identifies the deficiency or deficiencies on which the civil money penalty is based.</text> </paragraph> <paragraph num="(2)"> <text>The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies on which the civil money penalty was based has been verified.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account."> <paragraph num="A."> <text>A civil money penalty payment is due 15 calendar days after:</text> <paragraph num="(1)"> <text>The time period for requesting a hearing has expired, if a request for a hearing has not been received; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt of a written request from the agency to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The amount of the civil money penalty, when determined, may be deducted from any sum owed by the State to the agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Civil Money Penalties — Hearings."> <text>A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Emergency Suspensions."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-226(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the agency:</text> <paragraph num="(1)"> <text>Informing the agency of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the agency of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>Suspended License. If a license is suspended by emergency action, the agency shall:</text> <paragraph num="(1)"> <text>Immediately return the license to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Cease making referrals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter.</text> </paragraph> <paragraph num="F."> <text>The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .17 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="G."> <text>If the Secretary's final decision does not uphold the emergency suspension, the agency may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Denial or Revocation of License."> <paragraph num="A."> <text>Denial or Revocation of License. The Secretary, for cause shown, may notify the agency of the decision to revoke or deny the license. Except as provided in Regulation .15 of this chapter, the denial or revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>Criteria for Denial or Revocation. The Department shall notify the agency in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the denial or revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the denial or revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the denial or revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the agency is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the agency shall stop providing services on the effective date of the denial or revocation if the agency does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the denial or revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the agency is required to surrender its license to the Department if the denial or revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Hearings."> <paragraph num="A."> <text>An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 calendar days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as provided in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104 and Title 19, Subtitle 20, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 17, 2007 (34:25 Md. R. 2211)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 15, 2014 (41:18 Md. R. 1009)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, D amended effective December 21, 2015 (42:25 Md. R. 1542); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective June 5, 2017 (44:11 Md. R. 524)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="04" heading="Residential Treatment Centers for Emotionally Disturbed Children and Adolescents"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>The treatment and care of emotionally disturbed children and adolescents are of great concern to various State agencies including the Maryland Department of Health, Department of Human Services, Maryland State Department of Education and Department of Juvenile Justice.</text> </paragraph> <paragraph num="B."> <text>The Maryland Department of Health, Department of Human Services, Maryland State Department of Education, and Department of Juvenile Services, by statute, are responsible to ascertain that applicants for licenses conform to the regulations promulgated under the legal authority vested in the respective departments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards.</text> </paragraph> <paragraph num="(2)"> <text>“Accredited residential treatment center” means a residential treatment center that is accredited by:</text> <paragraph num="(a)"> <text>The Joint Commission on Accreditation of Healthcare Organizations;</text> </paragraph> <paragraph num="(b)"> <text>The Commission on Accreditation of Rehabilitation Facilities; or</text> </paragraph> <paragraph num="(c)"> <text>The Council on Accreditation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Adverse event” means an unexpected occurrence that:</text> <paragraph num="(a)"> <text>Is related to a resident’s medical or behavioral treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Is not related to the natural course of the resident’s illness or underlying disease condition.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Center” means a residential treatment center.</text> </paragraph> <paragraph num="(5)"> <text>“Change in condition” means a significant change in a resident’s physical, mental, or psychological status including:</text> <paragraph num="(a)"> <text>Life-threatening conditions;</text> </paragraph> <paragraph num="(b)"> <text>Clinical complications, including significant somatic symptoms that require the assessment or treatment by qualified medical personnel;</text> </paragraph> <paragraph num="(c)"> <text>The need to discontinue a medication or treatment because of:</text> <paragraph num="(i)"> <text>An adverse consequence; or</text> </paragraph> <paragraph num="(ii)"> <text>The need to begin a new form of treatment;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Evaluation at or admission to a hospital;</text> </paragraph> <paragraph num="(e)"> <text>Injuries that require the assessment of or treatment by qualified medical personnel;</text> </paragraph> <paragraph num="(f)"> <text>The use of restraint or seclusion; and</text> </paragraph> <paragraph num="(g)"> <text>Suicide attempts.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Fire authorities” means the official fire safety agency including the State Fire Marshal and local fire departments or fire marshals as appropriate.</text> </paragraph> <paragraph num="(8)"> <text>“Governing body” means the organizational structure that is responsible for all center operations, including:</text> <paragraph num="(a)"> <text>Establishing policy;</text> </paragraph> <paragraph num="(b)"> <text>Maintaining quality care; and</text> </paragraph> <paragraph num="(c)"> <text>Providing management and planning for the center.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Joint Commission” means the voluntary national healthcare accreditation service recognized for:</text> <paragraph num="(a)"> <text>Medicare certification purposes by Public Law 89-97; and</text> </paragraph> <paragraph num="(b)"> <text>Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Licensee” means the individual, partnership, association, or corporation to which a license is issued.</text> </paragraph> <paragraph num="(11)"> <text>“Nonaccredited residential treatment center” means a residential treatment center that is not accredited by:</text> <paragraph num="(a)"> <text>The Joint Commission on Accreditation of Healthcare Organizations;</text> </paragraph> <paragraph num="(b)"> <text>The Commission on Accreditation of Rehabilitation Facilities; or</text> </paragraph> <paragraph num="(c)"> <text>The Council on Accreditation.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(13)"> <text>“Resident” means any child or adolescent domiciled in a center for the purpose of receiving the services offered by a residential treatment center.</text> </paragraph> <paragraph num="(14)"> <text>“Residential treatment center” means a psychiatric institution that provides campus-based intensive and extensive evaluation and treatment of children and adolescents with severe and chronic emotional disturbances who require a self-contained therapeutic, educational, and recreational program in a residential setting.</text> </paragraph> <paragraph num="(15)"> <text>“Secretary" means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Requirements."> <paragraph num="A."> <text>License Required. A person may not establish, conduct, maintain, or operate in the State a center without first obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>Separate License Required. Centers maintained on separate premises shall obtain separate licenses, even though operated under the same management.</text> </paragraph> <paragraph num="C."> <text>License Not Required Under This Chapter. The following facilities are not deemed to be within the purview of these licensing requirements and are not required to obtain a license under these provisions:</text> <paragraph num="(1)"> <text>Any institution for well children, including day nurseries, child care centers, foster boarding homes, and institutions for intellectually disabled children; and</text> </paragraph> <paragraph num="(2)"> <text>Institutions operated by the Federal Government.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Posting of License. The license shall be posted conspicuously on the premises.</text> </paragraph> <paragraph num="E."> <text>Other Licensing Requirements. Before issuing a license the Secretary shall receive written notification that the center meets the following requirements:</text> <paragraph num="(1)"> <text>Clinical services and treatment program shall be approved by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Child care services and program shall be approved by the Department of Human Services in accordance with its published regulations;</text> </paragraph> <paragraph num="(3)"> <text>The educational program shall be approved by the State Department of Education.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Licensed Capacity. A center may not admit residents in excess of the number authorized and shown on the current license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>Application. Applicants shall conform to the following:</text> <paragraph num="(1)"> <text>An applicant desiring to open or to continue the operation of an existing center shall file with the Secretary, on a written or electronic form provided by the Secretary:</text> <paragraph num="(a)"> <text>The name of the applicant desiring the license; and</text> </paragraph> <paragraph num="(b)"> <text>The location of the center, the name of the person in charge, and any additional documents and information that the Secretary may require.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Application on behalf of a corporation or association or a governmental unit or agency shall be made by two of its officers, and the names of their board members shall be submitted.</text> </paragraph> <paragraph num="(3)"> <text>All licenses shall expire 3 years from the date of issuance unless revoked.</text> </paragraph> <paragraph num="(4)"> <text>The applicant for an original license shall submit the following, and insure that current copies are on file with the Department:</text> <paragraph num="(a)"> <text>Written permission from local zoning authority for an original license in municipalities which have established zoning;</text> </paragraph> <paragraph num="(b)"> <text>Written approval from the appropriate fire authorities;</text> </paragraph> <paragraph num="(c)"> <text>A current food service permit; and</text> </paragraph> <paragraph num="(d)"> <text>Copy of signed agreement between the center and the principal somatic physician and psychiatrist.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Renewal. Application for the renewal of the license shall be made each year at least 30 days before expiration of issued license, submitted on written or electronic forms provided by the Secretary.</text> </paragraph> <paragraph num="(6)"> <text>License renewal shall be based on accreditation by the Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation.</text> </paragraph> <paragraph num="(7)"> <text>The center shall be required to submit evidence of current accreditation that shall include:</text> <paragraph num="(a)"> <text>A copy of the current accreditation letter issued to the center;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the standards determined not to be in compliance, or with recommendations for improvement issued to the center; and</text> </paragraph> <paragraph num="(c)"> <text>The evidence of the action taken to correct noncompliance which was submitted to the accreditation organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Restrictions.</text> <paragraph num="(1)"> <text>Centers licensed under these regulations may not use in their title words “Hospital”, “Sanitarium”, “Nursing”, “Convalescent”, or “Rest”.</text> </paragraph> <paragraph num="(2)"> <text>A license shall be valid only in the hands of the licensee to whom it is issued and may not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor may a license be valid for any premises other than those for which originally issued.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Duration of License. Licenses are valid for 1 year from the date of issuance unless revoked.</text> </paragraph> <paragraph num="D."> <text>Licenses for Less Than 12 Months for the Operation of Hospitals and Related Institutions. The Secretary may issue a provisional license to a nonaccredited residential treatment center if:</text> <paragraph num="(1)"> <text>The nonaccredited residential treatment center is pending accreditation by The Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation; and</text> </paragraph> <paragraph num="(2)"> <text>The provision license is valid for a period not to exceed 12 months.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial or Revocation of License."> <paragraph num="A."> <text>The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="C."> <text>The Secretary may deny or revoke a license if the center does not meet the requirements of:</text> <paragraph num="(1)"> <text>Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A center subject to denial or revocation of license under this chapter, may request a hearing as set forth in accordance with Regulation .20 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inspection."> <text>Open to Inspection. A center licensed under this chapter and any premises proposed to be operated by an applicant for a license shall be open at all reasonable times to inspection by:</text> <paragraph num="A."> <text>The Secretary or designee;</text> </paragraph> <paragraph num="B."> <text>The Department of Human Services;</text> </paragraph> <paragraph num="C."> <text>The Maryland State Department of Education;</text> </paragraph> <paragraph num="D."> <text>The Department of Juvenile Services; or</text> </paragraph> <paragraph num="E."> <text>Any other agency authorized by the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="New Construction or Alteration."> <paragraph num="A."> <text>Submission of Plans. Plans shall be submitted to the Secretary before construction or alterations begin affecting its functional structure or normal bed capacity. These plans shall have the prior approval of local zoning authorities and the appropriate fire authorities. The Secretary shall review promptly the plans and shall notify the applicant or licensee within 30 days that the building, alteration, additions, or changes, are approved or disapproved with the recommendations that the Secretary may make. If an application is disapproved, the applicant or licensee shall be informed of the reasons at the time of notification.</text> </paragraph> <paragraph num="B."> <text>Application to Service Facilities. A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until complete plans and specifications have been submitted and approved in accordance with §A, of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Physical Plant."> <paragraph num="A."> <text>Construction. A new building designated as a residential treatment center and any existing building proposed for conversion for this use shall meet the following:</text> <paragraph num="(1)"> <text>The construction of the building shall prevent the entrance and harborage of rats and other rodents;</text> </paragraph> <paragraph num="(2)"> <text>The center shall comply with all other applicable governing laws or ordinances; and</text> </paragraph> <paragraph num="(3)"> <text>The center shall be constructed to comply with the requirements of the Americans with Disabilities Act.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Heating. A center shall be equipped with a central heating system capable of maintaining a minimum temperature of 68°F throughout the residential section of the building when the temperature falls to 0°F or below. Alternate modern types of heating systems may be accepted if approved by the fire authorities. Space heaters and portable heaters are not acceptable.</text> </paragraph> <paragraph num="C."> <text>Lighting.</text> <paragraph num="(1)"> <text>Lighting shall be adequate for the activities conducted in the various areas.</text> </paragraph> <paragraph num="(2)"> <text>Bedrooms and dormitories shall be lighted by outside windows and shall also have artificial light adequate for reading and other uses.</text> </paragraph> <paragraph num="(3)"> <text>All entrances, hallways, stairways, inclines, ramps, cellars, attics, storerooms, kitchens, laundries, and service units shall have sufficient artificial lighting to prevent accidents and promote efficiency of service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Bathrooms. A center shall provide the following minimum bathroom facilities:</text> <paragraph num="(1)"> <text>One hand sink and one toilet for each six residents of the same sex on each floor;</text> </paragraph> <paragraph num="(2)"> <text>One bathtub or shower for each 12 beds on each floor;</text> </paragraph> <paragraph num="(3)"> <text>The number of beds for which the center is licensed shall be used in determining the number of bathroom fixtures required even if some of the beds are not occupied;</text> </paragraph> <paragraph num="(4)"> <text>There shall be one complete bathroom on each floor used by the residents, regardless of the number of beds;</text> </paragraph> <paragraph num="(5)"> <text>All bath and toilet rooms shall be easily accessible, conveniently located and well lighted with a night light burning all night and have mechanical exhaust ventilation;</text> </paragraph> <paragraph num="(6)"> <text>A lavatory or toilet facility may not:</text> <paragraph num="(a)"> <text>Open directly into a kitchen, pantry or food preparation room; or</text> </paragraph> <paragraph num="(b)"> <text>Be located so that a resident is required to pass through another resident's room to enter it; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Bathrooms shall be constructed using anti-ligature fixtures and designed for the safety of the residents.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Plumbing.</text> <paragraph num="(1)"> <text>All plumbing within the building shall be installed in conformance with existing building and sanitary regulations.</text> </paragraph> <paragraph num="(2)"> <text>All sewage disposal shall be in accordance with existing regulations.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Water Supply.</text> <paragraph num="(1)"> <text>Centers shall be served by water from a safe public water supply, if available, as determined by the Department. If a safe public water supply is not available, a private water supply approved by the Department may be used.</text> </paragraph> <paragraph num="(2)"> <text>Adequacy. The supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve fixtures in the center.</text> </paragraph> <paragraph num="(3)"> <text>Temperature. The hot water heating equipment shall be of sufficient capacity to supply an adequate amount of water not in excess of 125°F for bathing and showering. The center shall install mixing valves or other anti-scalding devices.</text> </paragraph> <paragraph num="(4)"> <text>Hot water for kitchen and laundry use shall be at least 160°F.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Seclusion and Restraint.</text> <paragraph num="(1)"> <text>Seclusion and restraint rooms shall be constructed and maintained free of hazards to ensure the safety of the residents.</text> </paragraph> <paragraph num="(2)"> <text>The rooms shall allow for the unobstructed view of the resident.</text> </paragraph> <paragraph num="(3)"> <text>The rooms shall be equipped with adequate lighting for the staff to view the resident.</text> </paragraph> <paragraph num="(4)"> <text>Locking mechanisms on doors shall allow for prompt access in the event of an emergency.</text> </paragraph> <paragraph num="(5)"> <text>The rooms shall be adequate in size for staff to safely restrain residents or provide emergency care and treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Fire Regulations."> <text>A center shall be free from fire hazards and shall comply with all applicable local fire and building codes and the safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="General Requirements."> <paragraph num="A."> <text>Cleanliness and Maintenance. The following shall be observed:</text> <paragraph num="(1)"> <text>The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the first consideration.</text> </paragraph> <paragraph num="(2)"> <text>All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be easily cleanable.</text> </paragraph> <paragraph num="(3)"> <text>Adequate storage space shall be provided for excess supplies, personal possessions of residents and staff, linens, and similar items. This storage space may not constitute a fire or accident hazard, and may not be in the way of residents or staff. All supplies shall be stored 10 inches off the floor and away from the wall to allow for cleaning and pest control.</text> </paragraph> <paragraph num="(4)"> <text>The grounds shall be kept clean, neat, reasonably attractive, and free of hazards.</text> </paragraph> <paragraph num="(5)"> <text>The center shall be maintained free from insects and rodents.</text> </paragraph> <paragraph num="(6)"> <text>Bathtubs and hand sinks may not be used for laundering or storing soiled linens.</text> </paragraph> <paragraph num="(7)"> <text>Bathtubs and shower stalls may not be used for storage.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The center shall provide adequate furnishings and equipment to meet the needs of the residents, including but not limited to:</text> <paragraph num="(1)"> <text>Beds and mattresses in good repair;</text> </paragraph> <paragraph num="(2)"> <text>A storage area for each resident within their room;</text> </paragraph> <paragraph num="(3)"> <text>A desk and chair for each resident room; and</text> </paragraph> <paragraph num="(4)"> <text>Adequate furnishings in dayrooms and lounge areas to allow for recreational and relaxation purposes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Food Services."> <paragraph num="A."> <text>Dietary Requirements. The following minimum requirements shall be observed:</text> <paragraph num="(1)"> <text>A minimum of three meals in each 24 hour period shall be served. In addition, nutritious between meal and bedtime snacks should be offered to all residents no less than 1-1/2 to 2 hours before the next meal.</text> </paragraph> <paragraph num="(2)"> <text>There may not be an interval longer than 12 hours from the evening meal or substantial bedtime snack to breakfast. The diet shall consist of simply prepared, appropriately served, palatable foods including a minimum of the following daily:</text> <paragraph num="(b)"> <text>Meat, fish, poultry, eggs: Two servings per day;</text> </paragraph> <paragraph num="(c)"> <text>Vegetables and fruits: Four servings per day, including one serving of citrus fruit or tomato daily and one serving of a dark green or deep yellow vegetable or fruit five times weekly;</text> </paragraph> <paragraph num="(d)"> <text>Breads and Cereals: Four servings daily.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Size of servings and consistency or texture of food will be regulated by the age and condition of the residents.</text> </paragraph> <paragraph num="(4)"> <text>A record of the current week's menu plan shall be posted and kept on file for the following 2 weeks. A time schedule for service of meals to residents and personnel should be established and it is recommenced that meals be served approximately 4 hours apart for breakfast, lunch and dinner.</text> </paragraph> <paragraph num="(5)"> <text>Special diets or any variation of these requirements ordered by the resident's physician shall be provided for residents as ordered.</text> </paragraph> <paragraph num="(6)"> <text>Meals shall be served in a dining or community room equipped with furniture and utensils appropriate to the age and development of the residents. A resident with a temporary illness shall be served privately.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Sanitation and Personal Hygiene. All applicable requirements of COMAR 10.15.03 shall be observed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Management Requirements."> <paragraph num="A."> <text>Responsibility. The licensee is responsible for conformance with licensing regulations.</text> </paragraph> <paragraph num="B."> <text>Responsible Person. The licensee or administrator appointed by the licensee and all persons in supervisory or other responsible positions shall be 21 years old or older. The licensee shall ensure 24-hour coverage by an administrator or designee.</text> </paragraph> <paragraph num="C."> <text>Qualifications of Administrator.</text> <paragraph num="(1)"> <text>The administrator of the center shall be a psychiatrist, psychologist, social worker, registered nurse, or any other person trained in the behavioral sciences or in administration.</text> </paragraph> <paragraph num="(2)"> <text>The administrator shall be capable by experience and training of directing and supervising persons working in the center.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Financial Responsibility. The licensee shall provide to the Secretary assurance of financial responsibility to meet the minimum needs for services offered, safety, maintenance, food, and comfort of the residents of the center.</text> </paragraph> <paragraph num="E."> <text>Compliance with Regulations.</text> <paragraph num="(1)"> <text>The licensee shall charge the administrator to be familiar with this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The licensee or administrator shall also familiarize employees with those standards related to their work.</text> </paragraph> <paragraph num="(3)"> <text>The center’s governing body shall be responsible for the center’s compliance with all applicable federal and State regulations.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Availability of Information. The licensee or administrator shall make available to the Secretary such information as may be requested to ensure that the institution is meeting requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Health Services."> <paragraph num="A."> <text>Supervision of Treatment Program. Treatment at any center shall be under the direction of a qualified psychiatrist who is responsible for the adequacy, quality, and appropriateness of the treatment program for each resident. There shall be sufficient professional personnel to ensure the implementation of the treatment program for each resident.</text> </paragraph> <paragraph num="B."> <text>Medical Supervision. A resident shall be under the medical care of a physician licensed in the State. Each resident shall have a complete physical examination done within 30 days before admission, and updated within 72 hours after admission, and at appropriate, regularly scheduled intervals thereafter.</text> </paragraph> <paragraph num="C."> <text>Principal Physician. The center shall arrange for a physician to serve as principal physician and a qualified relief to cover periods when their services are not available. The medical director or assigned on call physician shall respond at times of emergency and be available as needed to advise the administrator and nursing staff on medical questions.</text> </paragraph> <paragraph num="D."> <text>Restrictions on Medication. Medication may not be given without the written order of a physician, nurse practitioner, or physician assistant except in an emergency when medication or treatment may be given on the verbal or telephone order of the prescriber. These orders shall be entered on the doctor's order sheet and shall be confirmed by the prescriber at the next visit.</text> </paragraph> <paragraph num="E."> <text>Medication Handling. The center shall comply with all applicable Federal, State, and local laws and ordinances, standards, and codes regulating the purchasing, handling, storage, administration, and recording of medications, including controlled substances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Staffing Requirements."> <paragraph num="A."> <text>The administrator shall employ sufficient and qualified personnel to ensure adequate treatment and care of the residents and the maintenance, cleaning, and housekeeping.</text> </paragraph> <paragraph num="B."> <text>The staff shall be sufficient in number so that the individual needs of residents are met.</text> </paragraph> <paragraph num="C."> <text>Provision shall be made for relief personnel during vacations or other relief periods. The relief personnel shall have qualifications equivalent to those of the person being relieved.</text> </paragraph> <paragraph num="D."> <text>Clinical staff shall, at a minimum, have current training in:</text> <paragraph num="(1)"> <text>CPR;</text> </paragraph> <paragraph num="(2)"> <text>The Heimlich maneuver; and</text> </paragraph> <paragraph num="(3)"> <text>First aid.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The center shall ensure that one or more competent trained individuals are present 24 hours a day with the required skills to address medical and behavioral emergencies.</text> </paragraph> <paragraph num="F."> <text>The center shall maintain personnel records on each employee, including:</text> <paragraph num="(1)"> <text>The initial application;</text> </paragraph> <paragraph num="(2)"> <text>Current professional license and certification;</text> </paragraph> <paragraph num="(3)"> <text>Criminal background checks; and</text> </paragraph> <paragraph num="(4)"> <text>Performance appraisals and annual competency evaluations.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Each staff member shall have a pre-employment examination for tuberculosis and additional testing when known TB exposure occurs.</text> </paragraph> <paragraph num="H."> <text>There shall be personnel policies which define staff jobs, qualifications, hours, vacation, sick leave, and retirement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Accommodations."> <paragraph num="A."> <text>Usable Living Space Needed.</text> <paragraph num="(1)"> <text>Each center shall provide at least 35 square feet of usable floor space per resident, in addition to bedroom space, in order to meet minimal requirements for dining, living, and recreational facilities.</text> </paragraph> <paragraph num="(2)"> <text>A minimum of 80 square feet is required for single occupancy bedrooms, and 60 square feet per bed for multiple occupancy bedrooms.</text> </paragraph> <paragraph num="(3)"> <text>Usable space excludes service areas, entrance ways, door swing areas, closets, dormers, and other breaks in floor areas.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Closet Space. Adequate closet space, conveniently located, shall be provided to allow each resident to keep necessary items of clothing and other personal belongings.</text> </paragraph> <paragraph num="C."> <text>Areas Devoted to Educational Programs. Provision of space for classrooms and other educational activities shall be made in accordance with the needs of the center as approved by the Department of Education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Restraints and Seclusion."> <text>The use of restraints and seclusion shall be in compliance with 42 CFR §§483.352—483.376 Condition of Participation for the Use of Seclusion and Restraint in Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services For Individuals Under Age 21.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Complaint Investigations."> <paragraph num="A."> <text>Notwithstanding any other provision of this chapter, residential treatment centers shall be open to inspections by the Department to investigate and resolve any complaint concerning:</text> <paragraph num="(1)"> <text>Resident care;</text> </paragraph> <paragraph num="(2)"> <text>Safety;</text> </paragraph> <paragraph num="(3)"> <text>Medical and nursing supervision;</text> </paragraph> <paragraph num="(4)"> <text>Physical environment;</text> </paragraph> <paragraph num="(5)"> <text>Sanitation; or</text> </paragraph> <paragraph num="(6)"> <text>Dietary matters.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Complaints.</text> <paragraph num="(1)"> <text>To expeditiously resolve a complaint that alleges the existence of any non-life-threatening deficiency, the Department may refer the complaint directly to the residential treatment center.</text> </paragraph> <paragraph num="(2)"> <text>If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional may be referred to the residential treatment center and to the appropriate health occupation licensing board for resolution.</text> </paragraph> <paragraph num="(3)"> <text>If the Department determines that the center has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a potentially serious or life-threatening deficiency, the Department shall conduct an independent investigation.</text> </paragraph> <paragraph num="(4)"> <text>When conducting its independent investigation of an accredited residential treatment center, the Department shall use the standards of the accreditation organization that accredits the residential treatment center and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Reports."> <paragraph num="A."> <text>The center shall furnish to the Secretary reports covering the following:</text> <paragraph num="(1)"> <text>Deaths, serious injuries, or unusual incidents, including suicide attempts, by no later than the close of business of the next business day following the event; and</text> </paragraph> <paragraph num="(2)"> <text>Any occurrences which threaten the welfare, safety, or health of any resident of the center such as fire, infectious disease outbreaks, or poisoning.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The center shall comply with the reporting requirements of the Department of Juvenile Services, the Department of Human Services, the Maryland State Department of Education, or other placement agencies.</text> </paragraph> <paragraph num="C."> <text>The center shall comply with the reporting requirements of 42 CFR §483.374(b) and (c).</text> </paragraph> <paragraph num="D."> <text>Serious Occurrence Notification.</text> <paragraph num="(1)"> <text>Staff shall report any serious occurrence described in 42 CFR §483.374(b) involving a resident to both the State Medicaid agency and the State-designated Protection and Advocacy System by not later than close of business the next business day after a serious occurrence.</text> </paragraph> <paragraph num="(2)"> <text>The report shall include:</text> <paragraph num="(a)"> <text>The name of the resident involved in the serious occurrence; and</text> </paragraph> <paragraph num="(b)"> <text>A description of the occurrence.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the case of a minor, the center shall notify the resident’s parent or parents or legal guardian or legal guardians:</text> <paragraph num="(a)"> <text>As soon as possible; or</text> </paragraph> <paragraph num="(b)"> <text>No later than 24 hours after the serious occurrence.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Staff shall document in the resident’s record that the serious occurrence was reported to both the State Medicaid agency and the State-designated Protection and Advocacy System, including the name of the individual to whom the incident was reported.</text> </paragraph> <paragraph num="(5)"> <text>A copy of the report shall be maintained in the resident’s record, as well as in the incident and accident report logs kept by the center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Civil Money Penalties."> <paragraph num="A."> <text>Civil Money Penalties. The Secretary may impose a civil money penalty on a person if:</text> <paragraph num="(1)"> <text>The person maintains or operates an unlicensed center; or</text> </paragraph> <paragraph num="(2)"> <text>A serious or life-threatening patient care deficiency exists and the center fails to correct the deficiency through immediate corrective action.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>Number, nature, and seriousness of the patient care deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the patient care deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the residents of the center that is caused by the patient care deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of the center to correct, the patient care deficiency or deficiencies through implementation of immediate corrective action; and</text> </paragraph> <paragraph num="(5)"> <text>The center’s prior history of compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department determines that a person has been operating an unlicensed center, the Department may impose a civil money penalty not to exceed $10,000.</text> </paragraph> <paragraph num="D."> <text>If the Department determines that a serious or life-threatening deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the center of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Impose a per-day civil money penalty not to exceed $10,000 until sustained compliance has been achieved;</text> </paragraph> <paragraph num="(2)"> <text>Permit the center the opportunity to correct the deficiencies by a specific date; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a per-instance civil money penalty not to exceed $10,000 for each instance of violation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Department permits a center the opportunity to correct the deficiencies by a specific date, and the center fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> <paragraph num="F."> <text>If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order is based;</text> </paragraph> <paragraph num="(2)"> <text>Amount of civil money penalties to be imposed; and</text> </paragraph> <paragraph num="(3)"> <text>Manner in which the amount of civil money penalties imposed was calculated.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A center subject to a civil money penalty under this regulation may request a hearing as set forth in accordance with Regulation .20 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.16.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as provided in COMAR 10.01.03.18.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.20.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Notifications."> <paragraph num="A."> <text>Within 24 hours of an event or change in condition and in accordance with State and federal confidentiality laws, a center shall attempt to notify a resident and a resident’s representative, family member, legal guardian, or custodian of:</text> <paragraph num="(1)"> <text>A change in the resident’s condition;</text> </paragraph> <paragraph num="(2)"> <text>An adverse event that affected the resident; and</text> </paragraph> <paragraph num="(3)"> <text>If appropriate, the corrective action taken.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The notification may be waived by the individual identified under Regulation .19A of this chapter if the individual sends a written response instructing the center that the individual:</text> <paragraph num="(1)"> <text>Waives the required notifications; or</text> </paragraph> <paragraph num="(2)"> <text>Requests that the notification be provided only under the circumstances identified in the written response.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All written responses waiving some or all notifications shall be maintained in the resident’s medical record.</text> </paragraph> <paragraph num="D."> <text>The center shall document in the medical records that the required notification were completed. The documentation shall include:</text> <paragraph num="(1)"> <text>The nature of the event or change in condition;</text> </paragraph> <paragraph num="(2)"> <text>The names of the individuals who received notification;</text> </paragraph> <paragraph num="(3)"> <text>The dates and times of the notifications; and</text> </paragraph> <paragraph num="(4)"> <text>The name of the staff who made the notifications.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a center has made reasonable attempts to notify the required individuals and has been unable to make contact, the failure to reach the individuals shall be documented in the medical records.</text> </paragraph> <paragraph num="F."> <text>If the Department determines that the center has failed to provide the required notification, the Department shall require the center as part of its plan of correction to provide notification as soon as possible.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Resident Rights."> <paragraph num="A."> <text>The center shall post the list of resident rights in areas of the center where the residents can read the posting. A resident of a residential treatment center has the right to:</text> <paragraph num="(1)"> <text>Be treated with respect;</text> </paragraph> <paragraph num="(2)"> <text>Have their cultural spiritual, personal beliefs, values, and preferences respected;</text> </paragraph> <paragraph num="(3)"> <text>Personal privacy;</text> </paragraph> <paragraph num="(4)"> <text>Practice their religious beliefs;</text> </paragraph> <paragraph num="(5)"> <text>Receive information about care and treatment in a manner that he or she understands;</text> </paragraph> <paragraph num="(6)"> <text>Be free from neglect, exploitation, and verbal, sexual, physical, and mental abuse;</text> </paragraph> <paragraph num="(7)"> <text>Access protection and advocacy services;</text> </paragraph> <paragraph num="(8)"> <text>Receive care in a safe setting;</text> </paragraph> <paragraph num="(9)"> <text>File a complaint and have it investigated without fear of retribution;</text> </paragraph> <paragraph num="(10)"> <text>Have visitors in accordance with the center’s visitation policy;</text> </paragraph> <paragraph num="(11)"> <text>Send and receive mail;</text> </paragraph> <paragraph num="(12)"> <text>Consult with their attorney, advocate, or social worker in private; and</text> </paragraph> <paragraph num="(13)"> <text>Make and receive telephone calls in accordance with the center’s policy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The resident’s parents or guardians or, if the resident is age 18 or older, the resident shall have the right to:</text> <paragraph num="(1)"> <text>Be involved in the treatment planning process;</text> </paragraph> <paragraph num="(2)"> <text>Consent to treatment and medication;</text> </paragraph> <paragraph num="(3)"> <text>Be informed of changes in the treatment plan and medication regimen;</text> </paragraph> <paragraph num="(4)"> <text>Withhold consent for treatment; and</text> </paragraph> <paragraph num="(5)"> <text>Have complaints investigated in a timely manner.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A resident’s rights shall only be restricted if the provision of that right poses a threat to the therapeutic needs of the resident or places the resident’s or other residents’ safety and security at risk.</text> </paragraph> <paragraph num="D."> <text>Restrictions on a resident’s rights shall be documented in the treatment plan and reviewed and approved by the treatment team.</text> </paragraph> <paragraph num="E."> <text>Restrictions on a resident’s rights shall be removed as soon as possible when the restriction is not therapeutically indicated.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-301, 19-305, 19-308, 19-309, 19-320, 19-323, and 19-360, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 17, 1967</annotation> <annotation type="History" subtype="Administrative History">Amended effective March 27, 1973</annotation> <annotation type="History" subtype="Administrative History">Amended effective March 22, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 22, 2017 (44:10 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective June 8, 2026 (53:11 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective June 8, 2026 (53:11 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.07.04 cited in Attorney General Opinion No. 82-034 (November 18, 1982)</annotation> </annotations> </chapter> <chapter num="05" heading="Residential Service Agencies"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to establish minimum standards for licensure of residential service agencies that conduct business in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means normal daily activities including:</text> <paragraph num="(a)"> <text>Eating or being fed;</text> </paragraph> <paragraph num="(b)"> <text>Grooming, bathing, oral hygiene including brushing teeth, shaving, and combing hair;</text> </paragraph> <paragraph num="(c)"> <text>Mobility, transferring, ambulation, and access to the outdoors, when appropriate;</text> </paragraph> <paragraph num="(d)"> <text>Toileting; and</text> </paragraph> <paragraph num="(e)"> <text>Dressing in clean, weather-appropriate clothing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Agency” means a residential service agency as defined in §B(25) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>“Branch office” means a satellite office of a residential service agency that:</text> <paragraph num="(a)"> <text>Is operated by the same person, corporation, or other business entity that manages the parent residential service agency; and</text> </paragraph> <paragraph num="(b)"> <text>Along with the parent residential service agency has the same:</text> <paragraph num="(i)"> <text>Ownership tax identification number as the parent residential service agency;</text> </paragraph> <paragraph num="(ii)"> <text>Upper-level management;</text> </paragraph> <paragraph num="(iii)"> <text>Policies and procedures; and</text> </paragraph> <paragraph num="(iv)"> <text>Services within the same geographic area as the parent residential service agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Certified care” means a service or services that:</text> <paragraph num="(a)"> <text>May be performed for compensation only by an individual who is certified by the Board of Nursing, including a certified medication technician, a certified medicine aide, or a certified nursing assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Include nursing functions that are routinely delegated by a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Certified medication technician” means an individual who:</text> <paragraph num="(a)"> <text>Has completed a Board-approved medication technician training program; and</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Board as a medication technician.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Certified medicine aide” means an individual who is:</text> <paragraph num="(a)"> <text>A certified nursing assistant who has completed a Board-approved course in medication administration; and</text> </paragraph> <paragraph num="(b)"> <text>Certified by the Board as a certified medicine aide.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certified nursing assistant” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Routinely performs for compensation delegated nursing tasks which were delegated by a registered nurse or licensed practical nurse; and</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Maryland Board of Nursing as a certified nursing assistant.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Client representative” means an individual with legal authority to make decisions on behalf of the client as set forth in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Clinical record” means a written account of all services provided to a client by the agency as well as all pertinent medical information necessary to provide care.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(11)"> <text>“Governing authority” means the individual, partnership, agency, group, corporation, or other entity that is designated to assume full responsibility for the policy determination, management, operation, and financial liability of the agency.</text> </paragraph> <paragraph num="(12)"> <text>“Home health care” includes any of the following services:</text> <paragraph num="(a)"> <text>Audiology and speech pathology;</text> </paragraph> <paragraph num="(b)"> <text>Dietary and nutritional services;</text> </paragraph> <paragraph num="(c)"> <text>Drug services;</text> </paragraph> <paragraph num="(d)"> <text>Home health aide;</text> </paragraph> <paragraph num="(e)"> <text>Laboratory;</text> </paragraph> <paragraph num="(f)"> <text>Medical social services;</text> </paragraph> <paragraph num="(g)"> <text>Nursing;</text> </paragraph> <paragraph num="(h)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(i)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(j)"> <text>Provision of invasive medical equipment; and</text> </paragraph> <paragraph num="(k)"> <text>Home medical equipment services.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Home medical equipment services” means the delivery, installation, maintenance, or replacement of, or instruction in the use of, medical equipment used by a sick or disabled individual to allow the individual to be maintained in a noninstitutional environment.</text> </paragraph> <paragraph num="(14)"> <text>“Household or family support services” means performance of tasks necessary to supplement an individual’s ability to perform:</text> <paragraph num="(a)"> <text>Child care for children who require no medical attention; or</text> </paragraph> <paragraph num="(b)"> <text>Instrumental activities of daily living.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Informal dispute resolution conference (IDR)” means an informal meeting that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection.</text> </paragraph> <paragraph num="(16)"> <text>“Informed consent” means the willing, uncoerced acceptance of medical intervention by a client or a client representative with legal authority to make health care decisions after adequate disclosure of the nature of the intervention, and its risks and benefits, as well as alternatives with their risks and benefits.</text> </paragraph> <paragraph num="(17)"> <text>“Instrumental activities of daily living” means:</text> <paragraph num="(a)"> <text>Light housekeeping and home management;</text> </paragraph> <paragraph num="(b)"> <text>Meal planning and preparation; or</text> </paragraph> <paragraph num="(c)"> <text>Shopping and errands.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Intravenous therapy” means the provision of services and monitoring and instruction related to substances that are administered intravenously, including but not limited to:</text> <paragraph num="(a)"> <text>Total parenteral nutrition (TPN);</text> </paragraph> <paragraph num="(b)"> <text>Hydration therapy;</text> </paragraph> <paragraph num="(c)"> <text>Chemotherapy;</text> </paragraph> <paragraph num="(d)"> <text>Antibiotic therapy; and</text> </paragraph> <paragraph num="(e)"> <text>Blood and blood products.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Invasive medical equipment” means a device that invades tissue or a body cavity for the purpose of maintaining treatment modalities, including but not limited to:</text> <paragraph num="(a)"> <text>Intravenous lines, whether enteral or parenteral;</text> </paragraph> <paragraph num="(b)"> <text>Catheters;</text> </paragraph> <paragraph num="(c)"> <text>Ventilators;</text> </paragraph> <paragraph num="(d)"> <text>Gastric or nasogastric tubes;</text> </paragraph> <paragraph num="(e)"> <text>Tracheostomy; and</text> </paragraph> <paragraph num="(f)"> <text>Ostomies.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Law enforcement agencies” mean the Maryland State Police or a police agency of a county or municipal corporation.</text> </paragraph> <paragraph num="(21)"> <text>“License” means a document issued by the Secretary to a person to operate a residential service agency in this State.</text> </paragraph> <paragraph num="(22)"> <text>“Medical equipment” means technologically sophisticated medical devices including but not limited to:</text> <paragraph num="(a)"> <text>Oxygen and oxygen delivery systems;</text> </paragraph> <paragraph num="(b)"> <text>Ventilators;</text> </paragraph> <paragraph num="(c)"> <text>Respiratory disease management devices;</text> </paragraph> <paragraph num="(d)"> <text>Electronic and computer-driven wheelchairs and seating systems;</text> </paragraph> <paragraph num="(e)"> <text>Apnea monitors;</text> </paragraph> <paragraph num="(f)"> <text>Transcutaneous electrical nerve stimulator (T.E.N.S.) units;</text> </paragraph> <paragraph num="(g)"> <text>Low air loss cutaneous pressure management devices;</text> </paragraph> <paragraph num="(h)"> <text>Sequential compression devices;</text> </paragraph> <paragraph num="(i)"> <text>Neonatal home phototherapy devices;</text> </paragraph> <paragraph num="(j)"> <text>Feeding pumps; and</text> </paragraph> <paragraph num="(k)"> <text>Electrically powered hospital beds.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Personal care provider under the Medical Assistance Personal Care Program” means an individual or personal care agency that has been approved by the Department as meeting requirements set forth in COMAR 10.09.20 and 10.09.36 to provide personal care services to individuals who are certified for and receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(24)"> <text>“Plan of correction” means a written response from the residential service agency that addresses each deficiency cited as a result of an inspection by the Department.</text> </paragraph> <paragraph num="(25)"> <text>Residential Service Agency.</text> <paragraph num="(a)"> <text>“Residential service agency” means:</text> <paragraph num="(i)"> <text>An individual, partnership, firm, association, corporation, or other entity of any kind that is engaged in a nongovernmental business of employing or contracting with individuals to provide at least one home health care service for compensation to an unrelated sick or disabled individual in the residence of that individual; or</text> </paragraph> <paragraph num="(ii)"> <text>An agency that employs or contracts with individuals directly for hire as home health care providers.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Residential service agency” does not include:</text> <paragraph num="(i)"> <text>A home health agency that is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>An individual, partnership, firm, association, corporation, or other entity of any kind that is required to be licensed as a home health agency under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A home-based hospice care program that is licensed under Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A hospital that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>A related institution that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>A nursing referral service agency that is licensed under Health-General Article, Title 19, Subtitle 4B, Annotated Code of Maryland, that screens or refers individuals for a client’s selection or rejection as its sole business operation, and does not itself provide any home health care service;</text> </paragraph> <paragraph num="(vii)"> <text>A personal care provider under the Medical Assistance Personal Care Program;</text> </paragraph> <paragraph num="(viii)"> <text>An individual practicing in a health occupation for which the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ix)"> <text>A business entity consisting of a group of individuals licensed under the same title of Health Occupations Article, Annotated Code of Maryland, which provides only that same, single, licensed health care service to its clients; or</text> </paragraph> <paragraph num="(x)"> <text>A residential rehabilitation services provider approved under regulations adopted under Health-General Article, §10-901, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(27)"> <text>Significant Change of Condition.</text> <paragraph num="(a)"> <text>“Significant change of condition” means a change in a client’s health, functional, or psychosocial condition that causes either an improvement or a deterioration in a client’s condition.</text> </paragraph> <paragraph num="(b)"> <text>“Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior or an acute short-term illness, such as a cold, unless these fluctuations continue to reoccur.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Skilled care” means a service or services that may be provided only by an individual who:</text> <paragraph num="(a)"> <text>Is licensed under Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Exercises specialized knowledge, judgment, and skill.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Skilled services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment.</text> </paragraph> <paragraph num="(30)"> <text>“Waiver of services” means an informed agreement by a competent adult client to receive certified care or skilled services that are less than the level of care that is recommended by the licensee or a representative of the licensee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person, partnership, corporation, association, or other entity may not conduct or operate an agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter.</text> </paragraph> <paragraph num="B."> <text>An agency that provides only household or family support services as defined in Regulation .02B(14) of this chapter does not require licensure.</text> </paragraph> <paragraph num="C."> <text>Separate License Required.</text> <paragraph num="(1)"> <text>Except as provided in §C(2) of this regulation, a separate license is required for each agency.</text> </paragraph> <paragraph num="(2)"> <text>A branch office may operate under the same license of the agency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Posting of a License. The licensee shall display the agency’s current license in a conspicuous place, at or near the entrance of the agency’s office.</text> </paragraph> <paragraph num="E."> <text>This chapter does not preclude an agency from operating with independent contractors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedures."> <paragraph num="A."> <text>Application for License.</text> <paragraph num="(1)"> <text>To obtain and maintain a license, an applicant shall meet all of the requirements of:</text> <paragraph num="(a)"> <text>This chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Other applicable federal, State, and local laws and regulations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant shall submit:</text> <paragraph num="(a)"> <text>An application on a written or electronic form developed by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Verification that the applicant or corporate representative is 21 years old or older;</text> </paragraph> <paragraph num="(c)"> <text>Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties;</text> </paragraph> <paragraph num="(d)"> <text>Identification of any individual or corporate owner of a 25 percent or more interest in the agency;</text> </paragraph> <paragraph num="(e)"> <text>Ownership information as specified on an addendum to the application;</text> </paragraph> <paragraph num="(f)"> <text>Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including prior or current operation of a similar health care program by the applicant;</text> </paragraph> <paragraph num="(g)"> <text>Disclosure of any criminal charges or convictions, and disclosure of any findings of violation of:</text> <paragraph num="(i)"> <text>Medicare and Medicaid laws and regulations;</text> </paragraph> <paragraph num="(ii)"> <text>Health-General Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Information demonstrating the financial or administrative ability to operate an agency in compliance with this chapter, which shall include at a minimum a business plan that contains a:</text> <paragraph num="(i)"> <text>1-year operating budget;</text> </paragraph> <paragraph num="(ii)"> <text>Marketing plan that identifies the populations to be served; and</text> </paragraph> <paragraph num="(iii)"> <text>Detailed and specific description of agency services;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Copies of the agency’s policies and procedures as specified in Regulation .08B of this chapter;</text> </paragraph> <paragraph num="(j)"> <text>Proof of Workers’ Compensation for all employees as required by the Maryland Workers’ Compensation Commission; and</text> </paragraph> <paragraph num="(k)"> <text>A nonrefundable license fee of $1,000 made payable to the Department for a 3-year licensing fee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Requirements for Initial Licensure.</text> <paragraph num="(1)"> <text>If the applicant, owner, or person identified in §A(2)(d) of this regulation has had their license suspended or revoked by the Department that person may not own, operate, or manage another agency for 10 years without good cause shown. After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an agency within the laws and regulations.</text> </paragraph> <paragraph num="(2)"> <text>If an applicant, owner, or person identified in §A(2)(d) of this regulation operates or manages an agency, that applicant, owner, or individual may not apply to open additional agencies, if the agency:</text> <paragraph num="(a)"> <text>Has had sanctions imposed within the last 2 years; and</text> </paragraph> <paragraph num="(b)"> <text>Has not achieved compliance with the regulations at the time of application for licensure.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department reserves the right to deny licensure for a residential service agency to an applicant, an owner, or an individual identified in §A(2)(d) of this regulation, based on that person’s prior:</text> <paragraph num="(a)"> <text>History of violations of residential service agency regulations; or</text> </paragraph> <paragraph num="(b)"> <text>Criminal history that the Department determines may be potentially harmful to clients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall review all applications for licensure to determine whether the applicant:</text> <paragraph num="(1)"> <text>Can provide appropriate services to sick or disabled individuals who require care in the individuals’ residence; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the regulatory requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to any other rights of inspection, before approving or denying an application for licensure, the Department may conduct an announced or unannounced on-site inspection of the agency.</text> </paragraph> <paragraph num="E."> <text>Based on information provided to the Department by the applicant, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application unconditionally;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application conditionally, which may include, among other conditions, requiring:</text> <paragraph num="(a)"> <text>The applicant to use the services of a management firm approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>A licensure term of less than 1 year; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Secretary may not require the use of a management firm for a period in excess of 24 months.</text> </paragraph> <paragraph num="G."> <text>A person aggrieved by a decision of the Secretary under this regulation to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .28 of this chapter.</text> </paragraph> <paragraph num="H."> <text>Duration of License. A license is valid for 3 years from the date of issuance, unless:</text> <paragraph num="(1)"> <text>Surrendered, suspended, or revoked; or</text> </paragraph> <paragraph num="(2)"> <text>It is a provisional license as described in §J of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>License Renewal. A licensee shall submit to the Department:</text> <paragraph num="(1)"> <text>An application for license renewal on a written or electronic form developed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>A nonrefundable license renewal fee of $1,000 made payable to the Department for a 3-year licensing fee;</text> </paragraph> <paragraph num="(3)"> <text>Copies of any policies and procedures that have changed substantively since they were previously reviewed by the Department, including those relevant to:</text> <paragraph num="(a)"> <text>Handling of complaints made to the agency; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluation and assessment of clients;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Valid professional licenses and certificates for all current employees; and</text> </paragraph> <paragraph num="(5)"> <text>An annual data collection survey in the form and manner prescribed by the Secretary with each application for license renewal.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Licenses for Less than 1 Year.</text> <paragraph num="(1)"> <text>The Department may issue a provisional license if:</text> <paragraph num="(a)"> <text>The agency intends to provide services limited to skilled nursing and home health aid services; or</text> </paragraph> <paragraph num="(b)"> <text>The residential service agency is not in full compliance with this chapter, but, in the opinion of the Department, the:</text> <paragraph num="(i)"> <text>Noncompliance does not constitute a safety or health hazard; and</text> </paragraph> <paragraph num="(ii)"> <text>Applicant or licensee has submitted a plan of correction that is acceptable to the Department which satisfactorily addresses the correction of each deficiency within a timeframe acceptable to the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A provisional license may not be extended beyond its expiration date.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If an agency fails to comply with the regulations of this chapter and the Department needs to conduct more than one on-site prelicensure visit, the Department may:</text> <paragraph num="(1)"> <text>Charge $250 per additional on-site visit; or</text> </paragraph> <paragraph num="(2)"> <text>Deny the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Changes in an Agency That Affect the Operating License."> <paragraph num="A."> <text>Change of Services or Name.</text> <paragraph num="(1)"> <text>During the licensure period, a licensee may not:</text> <paragraph num="(a)"> <text>Provide services for which it has not been approved to provide; or</text> </paragraph> <paragraph num="(b)"> <text>Change the name under which the program is doing business without the Department’s approval.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the licensee wants to provide additional services which require a license under this chapter, before offering the services, the licensee shall submit to the Department:</text> <paragraph num="(a)"> <text>A new application and written request for a new license citing the additional services the agency wants to provide;</text> </paragraph> <paragraph num="(b)"> <text>Policies and procedures pertaining to the additional services the agency wants to provide; and</text> </paragraph> <paragraph num="(c)"> <text>An application fee as required by Health-General Article, §19-4A-03(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When there is a change in name or address of the licensee, but no change of ownership, an amended license is required and the licensee shall pay $50 for the issuance of an amended license.</text> </paragraph> <paragraph num="(4)"> <text>Sale or Transfer of an Agency.</text> <paragraph num="(a)"> <text>If a sale or transfer of an agency causes a change in the person or persons who control or operate the agency, the agency is considered a new agency and the licensee shall apply for a new license and conform to all regulations applicable at the time of the transfer of operations.</text> </paragraph> <paragraph num="(b)"> <text>The transfer of any stock which results in a change of the person or persons who control the agency or the transfer of any stock in excess of 25 percent of the outstanding stock constitutes a sale.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Voluntary Closure or Change of Residential Service Agency Ownership.</text> <paragraph num="(1)"> <text>A licensee shall notify the Department in writing at least 45 days in advance of any intention to:</text> <paragraph num="(a)"> <text>Voluntarily close;</text> </paragraph> <paragraph num="(b)"> <text>Change ownership; or</text> </paragraph> <paragraph num="(c)"> <text>Sell its agency.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee shall include the following information in the notice to the Department:</text> <paragraph num="(a)"> <text>The method for informing clients or client representatives, if applicable, of its intent to close, change ownership, or sell its agency; and</text> </paragraph> <paragraph num="(b)"> <text>The actions the licensee will take to assist clients in securing comparable services and assistance, if necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee shall notify clients or client representatives, if applicable, of any proposed changes set forth in §B(1) of this regulation, in writing, at least 45 days before the effective date of the proposed change.</text> </paragraph> <paragraph num="(4)"> <text>Whenever ownership of an agency is transferred from the person or organization named on the license to another person or organization, the future owner shall apply for a new license. The future owner shall file an application for a license at least 45 days before the transfer.</text> </paragraph> <paragraph num="(5)"> <text>The Department shall issue a new license to a new owner who meets the requirements for licensure under this chapter. The former licensee shall return its license to the Department by certified mail.</text> </paragraph> <paragraph num="(6)"> <text>A licensee named in the original license remains responsible for the operation of the agency until a new license is issued to the new owner. The current licensee remains responsible for correction of all outstanding deficiencies and impending sanctions until a new license is issued to the new owner. After a new license is issued, the new owner shall become responsible for correction of all outstanding deficiencies and impending sanctions.</text> </paragraph> <paragraph num="(7)"> <text>In addition to the notice to the Department required by §B(1) and (2) of this regulation, after an agency closes, the licensee shall:</text> <paragraph num="(a)"> <text>Notify the Department of the date of closure; and</text> </paragraph> <paragraph num="(b)"> <text>Return all licenses, past and present, to the Department by certified mail.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Changes to Licensure Information. A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application.</text> </paragraph> <paragraph num="D."> <text>License — Sale, Assignment, or Transfer. The license is valid in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer.</text> </paragraph> <paragraph num="E."> <text>If an agency fails to comply with §§A—D of this regulation, the Department may impose a fine of up to $500 for each violation..</text> </paragraph> <paragraph num="F."> <text>A license is void if the agency ceases to operate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Special Requirements for the Provision of Home Medical Equipment Services."> <paragraph num="A."> <text>A provider of home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .02—.03 of this chapter.</text> </paragraph> <paragraph num="B."> <text>An agency shall:</text> <paragraph num="(1)"> <text>Ensure that personnel demonstrate competency in delivering and installing the equipment;</text> </paragraph> <paragraph num="(2)"> <text>Provide education, training, and written instructions to the patient and his or her caregivers on the use of the equipment before the equipment is used, and provide retraining as needed;</text> </paragraph> <paragraph num="(3)"> <text>Provide the patient and caregivers with the telephone number of persons who can deliver critical care on an emergency basis;</text> </paragraph> <paragraph num="(4)"> <text>Provide the prescribing physician with a copy of the:</text> <paragraph num="(a)"> <text>Qualifications, duties, and responsibilities of agency personnel who deliver the services, and</text> </paragraph> <paragraph num="(b)"> <text>Instructions given to the patient and the patient's caregivers;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintain a clinical record for each patient receiving home medical equipment services; and</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the installation, maintenance, repair, and storage of home medical equipment meet with manufacturer's specifications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Public Representation."> <paragraph num="A."> <text>An agency shall include the following information in all of the agency’s advertising and marketing materials:</text> <paragraph num="(1)"> <text>The agency’s license number; and</text> </paragraph> <paragraph num="(2)"> <text>The statement “Licensed as a residential service agency by the Maryland Department of Health, Office of Health Care Quality”.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Misleading or False Advertising.</text> <paragraph num="(1)"> <text>A person may not advertise, represent, or imply to the public that an agency is authorized to provide a service that the agency is not licensed, certified, or otherwise authorized by the Department to provide under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A person may not advertise an agency in a misleading or fraudulent manner.</text> </paragraph> <paragraph num="(3)"> <text>A person licensed as an agency may not advertise that it is licensed as a hospice, home health agency, or nursing referral service agency unless it is separately licensed with the Department as such.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person who violates this regulation is subject to referral for criminal prosecution and imposition of civil money penalties in accordance with Regulations .21—.23 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspection by the Department."> <paragraph num="A."> <text>Residential Service Agency to be Open for Inspection.</text> <paragraph num="(1)"> <text>The Department or its designee may conduct announced or unannounced licensure inspections or complaint investigations to ensure compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The agency shall be open for inspection by the Department during all hours identified in the agency’s application as routine business hours.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Access to Agency and Sites Where Services Are Offered. Upon the request of the Department, an agency shall:</text> <paragraph num="(1)"> <text>Make its offices available for inspection during other than its routine business hours;</text> </paragraph> <paragraph num="(2)"> <text>Assist the Department in gaining access to sites where services are provided for the purpose of conducting inspections to:</text> <paragraph num="(a)"> <text>Ensure that the agency is in compliance with the regulations of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Enable the Department to investigate and resolve complaints filed against the agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Records and Reports.</text> <paragraph num="(1)"> <text>Inspection.</text> <paragraph num="(a)"> <text>A licensee shall maintain records and reports to support compliance with the regulations of this chapter. All records and reports shall be open to inspection by the Department.</text> </paragraph> <paragraph num="(b)"> <text>Except for the records permitted to be stored off site, a licensee or licensee’s designee shall immediately, upon request, provide copies of records and reports, including medical records of clients, to the Department. The Department shall, if requested, reimburse the licensee for the cost of copying records and reports.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintenance.</text> <paragraph num="(a)"> <text>The residential service agency shall maintain files on site pertaining to:</text> <paragraph num="(i)"> <text>Current clients;</text> </paragraph> <paragraph num="(ii)"> <text>Clients that have been discharged within the last 12 months;</text> </paragraph> <paragraph num="(iii)"> <text>Current staff;</text> </paragraph> <paragraph num="(iv)"> <text>Staff that have been discharged within the last year; and</text> </paragraph> <paragraph num="(v)"> <text>Quality assurance activities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>All other records may be stored off site, but shall be available for inspection within 24 hours of the Department’s request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An agency shall make available upon request to clients, client representatives, potential clients, or federal, State, or local regulatory or law enforcement agencies any statements of deficiencies, reports, and plans of corrections.</text> </paragraph> <paragraph num="E."> <text>Notice of Violations.</text> <paragraph num="(1)"> <text>If a complaint investigation or survey inspection identifies a regulatory violation, the Secretary shall issue a notice:</text> <paragraph num="(a)"> <text>Citing the violation or deficiency;</text> </paragraph> <paragraph num="(b)"> <text>Requiring the residential service agency to submit an acceptable plan of correction within 10 calendar days of receipt of the notice of violation or deficiency;</text> </paragraph> <paragraph num="(c)"> <text>Advising the residential service agency that failure to correct cited violations or deficiencies may result in sanctions; and</text> </paragraph> <paragraph num="(d)"> <text>Offering the residential service agency the opportunity for an informal dispute resolution conference (IDR).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The plan of correction referred to in §E(1)(b) of this regulation shall include the date by which the licensee shall complete the correction of each deficiency. Failure to return an acceptable plan of correction within the allotted timeframe may result in a sanction.</text> </paragraph> <paragraph num="(3)"> <text>When a licensee requests an IDR as provided in §F of this regulation, the licensee shall file a plan of correction within the required time, except to the extent that the licensee contests specific findings. If the licensee contests specific findings, absent the Department’s directive, a licensee may delay submitting its plan of correction with respect to those specific findings until 5 days after the licensee is provided oral or written notice of the outcome of the IDR.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Informal Dispute Resolution (IDR).</text> <paragraph num="(1)"> <text>A licensee may request an informal dispute resolution conference (IDR) to question violations or deficiencies within 10 days of receiving the statement of deficiencies. The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by any supporting documentation.</text> </paragraph> <paragraph num="(2)"> <text>At the discretion of the Office of Health Care Quality, the IDR may be held in person, by telephone, or in writing. In-person IDRs are informal in nature and are not attended by counsel.</text> </paragraph> <paragraph num="(3)"> <text>The IDR process may not delay the effective date of any enforcement action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Administration."> <paragraph num="A."> <text>Governing Authority.</text> <paragraph num="(1)"> <text>The agency shall have a governing authority.</text> </paragraph> <paragraph num="(2)"> <text>The governing authority shall:</text> <paragraph num="(a)"> <text>Convene at least annually with management staff to review and advise the agency on policies; and</text> </paragraph> <paragraph num="(b)"> <text>Keep minutes, including:</text> <paragraph num="(i)"> <text>The participants of any meeting;</text> </paragraph> <paragraph num="(ii)"> <text>Agenda items considered; and</text> </paragraph> <paragraph num="(iii)"> <text>Actions taken.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Policies and Procedures.</text> <paragraph num="(1)"> <text>An agency shall develop and implement policies and procedures, including but not limited to:</text> <paragraph num="(a)"> <text>Administration, including:</text> <paragraph num="(i)"> <text>Scope of services;</text> </paragraph> <paragraph num="(ii)"> <text>Delineation of services provided by the agency when the agency coordinates care within the agency or with another provider;</text> </paragraph> <paragraph num="(iii)"> <text>Notification to the client or client representative with legal authority to make health care decisions of the agency’s responsibilities to coordinate care when appropriate;</text> </paragraph> <paragraph num="(iv)"> <text>Admission criteria;</text> </paragraph> <paragraph num="(v)"> <text>Assessment of potential clients before their acceptance into the program;</text> </paragraph> <paragraph num="(vi)"> <text>Billing and service records, maintenance of charges, and similar items, except for those clients receiving services through a managed-care health benefits plan or third party payor, in which case records are maintained as required by the third party payor;</text> </paragraph> <paragraph num="(vii)"> <text>Quality assurance program; and</text> </paragraph> <paragraph num="(viii)"> <text>Clinical management, including assessment, plans, delegation, and supervision;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Personnel, including:</text> <paragraph num="(i)"> <text>Job descriptions and educational qualifications for all employees and contractors;</text> </paragraph> <paragraph num="(ii)"> <text>Skill assessments of all employees and contractors; and</text> </paragraph> <paragraph num="(iii)"> <text>Health requirements for employees and contractors;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Patient care, including:</text> <paragraph num="(i)"> <text>Provision of home health care services and criteria for determining the need for skilled services;</text> </paragraph> <paragraph num="(ii)"> <text>Administration of drugs;</text> </paragraph> <paragraph num="(iii)"> <text>Enteral and parenteral nutrition procedures;</text> </paragraph> <paragraph num="(iv)"> <text>Frequency of client monitoring; and</text> </paragraph> <paragraph num="(v)"> <text>Training and retraining of clients or their family members, when indicated;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Informed consent when:</text> <paragraph num="(i)"> <text>A client or client representative with legal authority to make legal decisions, signs an informed consent form consenting to changes to the agency’s recommended plan of care; or</text> </paragraph> <paragraph num="(ii)"> <text>A client signs an informed consent form consenting to assistance by a nonlicensed individual with treatments of a routine nature, or with the self-administration of medications; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Environment and safety, including:</text> <paragraph num="(i)"> <text>Preparation and storage of enteral formulas, intravenous therapies, other supplies, equipment, and similar items;</text> </paragraph> <paragraph num="(ii)"> <text>Infection control procedures;</text> </paragraph> <paragraph num="(iii)"> <text>Disposal of biomedical waste;</text> </paragraph> <paragraph num="(iv)"> <text>Maintenance of equipment; and</text> </paragraph> <paragraph num="(v)"> <text>Emergency procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may waive the requirement of a policy and procedure that is required in §B of this regulation upon the agency’s written explanation as to why the policy and procedure is inappropriate or unnecessary to the agency’s specific operation.</text> </paragraph> <paragraph num="(3)"> <text>An agency that provides invasive equipment or supplies, such as intravenous therapy, shall arrange for 24-hour-a-day equipment maintenance service in case of equipment failure.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Complaint Process."> <paragraph num="A."> <text>Internal Complaint Process. An agency shall institute an internal client complaint process that includes:</text> <paragraph num="(1)"> <text>Notice to the client or the client representative of the complaint process;</text> </paragraph> <paragraph num="(2)"> <text>Protocols to investigate complaints; and</text> </paragraph> <paragraph num="(3)"> <text>A mechanism for the receipt and timely investigation of written complaints that ensures that the client’s services will not be disrupted due to the filing of a complaint.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Internal Complaint Investigations.</text> <paragraph num="(1)"> <text>All investigation reports shall include:</text> <paragraph num="(a)"> <text>Time, date, place, and individuals involved;</text> </paragraph> <paragraph num="(b)"> <text>Complete description of the complaint;</text> </paragraph> <paragraph num="(c)"> <text>Disposition of the complaint; and</text> </paragraph> <paragraph num="(d)"> <text>Follow-up activities and steps taken to prevent its reoccurrence.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the agency does not conduct a complaint investigation, the agency shall document in the complaint record the reason for not conducting an investigation.</text> </paragraph> <paragraph num="(3)"> <text>An agency shall provide notice to the following persons regarding the disposition of a complaint:</text> <paragraph num="(a)"> <text>Client, or if the client is incompetent, the client representative;</text> </paragraph> <paragraph num="(b)"> <text>Client’s physician, if needed; and</text> </paragraph> <paragraph num="(c)"> <text>Licensing or law enforcement agencies, when required by law.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An agency shall maintain records to support its internal complaint investigation process.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An agency shall provide notice to clients of the Department’s complaint hotline number for complaints about services provided by the agency or services that the agency failed to provide.</text> </paragraph> <paragraph num="D."> <text>Availability of Internal Investigation Reports.</text> <paragraph num="(1)"> <text>The agency shall make investigation reports available to the Department immediately upon request.</text> </paragraph> <paragraph num="(2)"> <text>An agency shall provide a summary report of any complaint investigation for public inspection, upon request, to the extent permitted by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Employee, Independent Contractor, and Contractual Employee Requirements."> <paragraph num="A."> <text>An agency shall develop and implement policies and procedures to screen a prospective employee, independent contractor, or contractual employee who will provide services to clients.</text> </paragraph> <paragraph num="B."> <text>Screening.</text> <paragraph num="(1)"> <text>Screening shall include:</text> <paragraph num="(a)"> <text>A State criminal history records check or a private agency background check as required under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Verification of current professional licensure or certification under Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A basic health screening, including tuberculosis screening;</text> </paragraph> <paragraph num="(d)"> <text>Verification of references;</text> </paragraph> <paragraph num="(e)"> <text>Verification of employment history;</text> </paragraph> <paragraph num="(f)"> <text>Completion of I-9 forms for employment;</text> </paragraph> <paragraph num="(g)"> <text>Verification of identity and employment eligibility of an employee, independent contractor, or contractual employee;</text> </paragraph> <paragraph num="(h)"> <text>An in-person interview of an employee, independent contractor, or contractual employee before the individual is referred to clients; and</text> </paragraph> <paragraph num="(i)"> <text>Completion of a skills assessment and demonstration before client referral.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An agency shall retain records of training in the personnel file.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An agency shall maintain records of information described in §B of this regulation for each employee, independent contractor, or contractual employee and retain the information in the agency’s business office.</text> </paragraph> <paragraph num="D."> <text>An agency may not knowingly provide or refer a caregiver who is not certified to provide services to a client unless the client:</text> <paragraph num="(1)"> <text>Does not require the caregiver to provide assistance with activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Only requires assistance with activities of daily living and in the judgment of the supervising nurse, there are no predictable adverse health consequences; or</text> </paragraph> <paragraph num="(3)"> <text>Signs a waiver of skilled services form as required under Regulation .12D of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An agency shall provide or refer a certified caregiver to a client who requires:</text> <paragraph num="(1)"> <text>A certified caregiver to perform activities of daily living; or</text> </paragraph> <paragraph num="(2)"> <text>Administration of medication.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If an agency is aware of an action or inaction by an individual who is provided or referred by the agency that may be grounds for action under Health Occupations Article, §§8-316 and 8-6A-10, Annotated Code of Maryland, the agency shall report the action or condition to the Board of Nursing and the Office of Health Care Quality immediately when the action or condition is known by the agency.</text> </paragraph> <paragraph num="G."> <text>A nursing administrator, a registered nurse, a licensed practical nurse, and a certified nursing assistant shall have immunity from liability as described in Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation. Other persons are entitled to the immunity from liability as described in the Courts and Judicial Proceedings Article, §5-708, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation.</text> </paragraph> <paragraph num="H."> <text>Use of Subcontract Agencies. If an agency subcontracts with another licensed agency to provide services, the subcontracting agency shall:</text> <paragraph num="(1)"> <text>Verify personnel information outlined in §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Submit evidence to the contracting agency that verification has occurred.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Training."> <paragraph num="A."> <text>An agency shall ensure that individuals that are referred are trained appropriately to provide care that is needed by the agency’s clients.</text> </paragraph> <paragraph num="B."> <text>Sources other than the agency may provide training, as approved in writing by the Office of Health Care Quality.</text> </paragraph> <paragraph num="C."> <text>At a minimum, training for individuals providing care in clients’ homes shall include:</text> <paragraph num="(1)"> <text>Instruction and supervised practice in relevant personal care services of the sick or disabled at home;</text> </paragraph> <paragraph num="(2)"> <text>Identification of situations that require referral to a registered nurse, including significant changes in a client’s condition;</text> </paragraph> <paragraph num="(3)"> <text>Record keeping;</text> </paragraph> <paragraph num="(4)"> <text>Ethical behavior and confidentiality of information;</text> </paragraph> <paragraph num="(5)"> <text>CPR;</text> </paragraph> <paragraph num="(6)"> <text>Standard precautions for infection control; and</text> </paragraph> <paragraph num="(7)"> <text>Prevention of abuse and neglect.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Services Provided."> <paragraph num="A."> <text>An agency shall take reasonable measures to ensure that all individuals who are referred to provide services to clients do so in accordance with Maryland laws and regulations, including but not limited to the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Provision of Services.</text> <paragraph num="(1)"> <text>A registered nurse shall assess each new client who requires skilled services and assistance with the activities of daily living.</text> </paragraph> <paragraph num="(2)"> <text>The registered nurse shall also:</text> <paragraph num="(a)"> <text>Participate in developing the client’s plan of care and in assigning appropriate personnel;</text> </paragraph> <paragraph num="(b)"> <text>Determine whether the client requires the services of a certified nursing assistant, or whether services may be provided by an individual who is not certified; and</text> </paragraph> <paragraph num="(c)"> <text>Participate in training and retraining the individuals who will provide the care, when indicated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Plan of Care.</text> <paragraph num="(1)"> <text>A client’s plan of care shall be based on assessments of the client’s health, function, and psychosocial condition.</text> </paragraph> <paragraph num="(2)"> <text>An assessment of a client shall be completed:</text> <paragraph num="(a)"> <text>When the client is requesting or requiring services regulated by this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Before the client receives services from the agency unless:</text> <paragraph num="(i)"> <text>The client does not request skilled care or skilled services; and</text> </paragraph> <paragraph num="(ii)"> <text>There is no reason to believe that the client requires skilled care or skilled services, such as discharge instructions requiring skilled care;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Within 48 hours of when the client begins services when the client requires, including but not limited to:</text> <paragraph num="(i)"> <text>Wound and catheter care;</text> </paragraph> <paragraph num="(ii)"> <text>Treatment of stage three or stage four skin ulcers;</text> </paragraph> <paragraph num="(iii)"> <text>Ventilator services;</text> </paragraph> <paragraph num="(iv)"> <text>Skilled monitoring, testing, and aggressive adjustment of medications and treatments where there is the presence of, or risk for, a fluctuating acute condition;</text> </paragraph> <paragraph num="(v)"> <text>Monitoring of a chronic medical condition that is not readily controllable through available medications and treatments;</text> </paragraph> <paragraph num="(vi)"> <text>Infusion therapy;</text> </paragraph> <paragraph num="(vii)"> <text>Specialized intravenous therapies or nutrition support;</text> </paragraph> <paragraph num="(viii)"> <text>Monitoring for being at high risk for health or safety complications which cannot be adequately managed; or</text> </paragraph> <paragraph num="(ix)"> <text>A different level of care after notification of a significant change of condition;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>At the request of the client or the client representative;</text> </paragraph> <paragraph num="(e)"> <text>At least annually; and</text> </paragraph> <paragraph num="(f)"> <text>Except in the following circumstances:</text> <paragraph num="(i)"> <text>Weather-related emergencies;</text> </paragraph> <paragraph num="(ii)"> <text>Natural disasters; or</text> </paragraph> <paragraph num="(iii)"> <text>Federal, state, or local declaration of an emergency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>When a registered nurse determines in the nurse’s clinical judgment that the client does not require an assessment within 48 hours of a significant change of condition as provided in §C(2)(c) of this regulation, the registered nurse shall:</text> <paragraph num="(a)"> <text>Document the determination in the client’s record; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that an assessment of the client is conducted within 7 calendar days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The agency shall ensure that the care plan developed for the client at a minimum addresses:</text> <paragraph num="(a)"> <text>The services to be provided to the client, which are based on the assessment of the client;</text> </paragraph> <paragraph num="(b)"> <text>When and how often the services are to be provided;</text> </paragraph> <paragraph num="(c)"> <text>How and by whom the services are to be provided;</text> </paragraph> <paragraph num="(d)"> <text>Long-range and short-range goals for the client; and</text> </paragraph> <paragraph num="(e)"> <text>Physical needs, including safety measures to protect against injury.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Client care plans shall be reviewed by a registered nurse or another health care practitioner who is authorized to do so under Health Occupations Article, Annotated Code of Maryland, when appropriate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Informed Consent.</text> <paragraph num="(1)"> <text>An adult client who is competent to make decisions or a client representative with legal authority to make health care decisions may consent to make changes to the agency’s recommended plan of care.</text> </paragraph> <paragraph num="(2)"> <text>A cognitively capable adult client, but not a client representative with legal authority to make health care decisions, may waive the licensee’s recommendation of certified care services to be provided in the adult client’s home to assist with treatments of a routine nature, or with the self-administration of medications.</text> </paragraph> <paragraph num="(3)"> <text>A cognitively capable adult client may waive the licensee’s recommended skilled care.</text> </paragraph> <paragraph num="(4)"> <text>Consents.</text> <paragraph num="(a)"> <text>The consent given under §D(1)—(3) of this regulation may be granted only after a discussion of the risks and benefits with the client or, if appropriate, the client representative with legal authority to make health care decisions. This discussion shall be reflected in an informed consent form.</text> </paragraph> <paragraph num="(b)"> <text>The informed consent form shall be:</text> <paragraph num="(i)"> <text>Signed and dated by the client, or the client representative with legal authority over health care decisions; and</text> </paragraph> <paragraph num="(ii)"> <text>Documented in the client’s records.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A form confirming a waiver of skilled services shall be signed by a cognitively capable adult client and maintained in the client’s record.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Client medications shall be administered in accordance with §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Nursing Supervision.</text> <paragraph num="(1)"> <text>For clients who require skilled services or assistance with the activities of daily living, an agency shall have a registered nurse to provide oversight for:</text> <paragraph num="(a)"> <text>Implementation of the care plan;</text> </paragraph> <paragraph num="(b)"> <text>Delegation;</text> </paragraph> <paragraph num="(c)"> <text>Supervision; and</text> </paragraph> <paragraph num="(d)"> <text>Training.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The registered nurse shall provide periodic, on-site supervision of care:</text> <paragraph num="(a)"> <text>At least every 45 days if the staff administers medications to the client;</text> </paragraph> <paragraph num="(b)"> <text>At least every 3 months if the staff assists the client with self-administration of medications;</text> </paragraph> <paragraph num="(c)"> <text>At least every 4 months if the staff does not administer medications or assist the client with medication self-administration; or</text> </paragraph> <paragraph num="(d)"> <text>At a greater frequency established by the registered nurse due to the client's medical condition or clinical status.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The agency shall maintain accurate documentation of the supervision that is provided by the registered nurse.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Medication Administration. If agency employees, independent contractors, or contractual employees administer medications, the agency shall:</text> <paragraph num="(1)"> <text>Provide for administration of drugs and treatments by licensed or certified staff consistent with Maryland law and the client’s plan of care, unless the client has executed an informed consent form under §D of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Provide for drugs and treatments to be administered only as ordered by the physician; and</text> </paragraph> <paragraph num="(3)"> <text>Document in the client’s clinical record:</text> <paragraph num="(a)"> <text>Medications administered or taken;</text> </paragraph> <paragraph num="(b)"> <text>Medication errors; and</text> </paragraph> <paragraph num="(c)"> <text>Adverse drug reactions and corrective action.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>On-Call Services. The agency shall:</text> <paragraph num="(1)"> <text>Establish a procedure by which current clients or their representatives may contact a representative of the agency by communication device at any time, 24 hours a day and 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>Recognize and respond to emergency inquiries in a manner that is consistent with medical and nursing standards;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the inquiry is directed to an individual for response as required by medical and nursing standards;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the individual responds to an inquiry not later than 1 hour after the inquiry is received by the agency or sooner as necessitated by medical standards;</text> </paragraph> <paragraph num="(5)"> <text>Maintain a log of inquiries that includes the identity of the response personnel, content of the inquiry, and the time of each inquiry; and</text> </paragraph> <paragraph num="(6)"> <text>Provide clients or the client representatives with written procedures and the phone number for on-call service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Client Representative."> <paragraph num="A."> <text>An agency shall recognize the authority of:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An advanced directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with the authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>A power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>A representative payee or other similar fiduciary; or</text> </paragraph> <paragraph num="(7)"> <text>Any other person, if that person was designated by a client who was competent at the time of designation, and the client or client representative has provided the agency with documentation of the designation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An agency may not recognize the authority of a client representative if the representative attempts to exceed the authority:</text> <paragraph num="(1)"> <text>Stated in the instrument that grants the representative authority; or</text> </paragraph> <paragraph num="(2)"> <text>Established by State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An agency shall:</text> <paragraph num="(1)"> <text>Document in the client’s record the name of the person, if any, with the authority identified in §A of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Include the documentation creating the authority in the record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Clinical Records."> <paragraph num="A."> <text>With the exception of §B of this regulation, an agency shall ensure that a clinical record is maintained for each client in a manner that ensures security and confidentiality, and includes at a minimum:</text> <paragraph num="(1)"> <text>The documentation required by §D of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Any currently effective health care orders;</text> </paragraph> <paragraph num="(3)"> <text>Nurse’s assessment</text> </paragraph> <paragraph num="(4)"> <text>Rehabilitation plans, if appropriate;</text> </paragraph> <paragraph num="(5)"> <text>The care plan;</text> </paragraph> <paragraph num="(6)"> <text>Medications administered or taken, including:</text> <paragraph num="(a)"> <text>Dosage;</text> </paragraph> <paragraph num="(b)"> <text>Route of administration; and</text> </paragraph> <paragraph num="(c)"> <text>Frequency;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>History of sensitivities or allergic reactions;</text> </paragraph> <paragraph num="(8)"> <text>Nutritional requirements, including specific dietary plans;</text> </paragraph> <paragraph num="(9)"> <text>Medically necessary supplies and equipment;</text> </paragraph> <paragraph num="(10)"> <text>Care notes;</text> </paragraph> <paragraph num="(11)"> <text>The name, address, and telephone number of:</text> <paragraph num="(a)"> <text>The client’s physicians; and</text> </paragraph> <paragraph num="(b)"> <text>The client representative; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>The following documents for each client upon discharge:</text> <paragraph num="(a)"> <text>Directions for the safe continuation of care after discharge; and</text> </paragraph> <paragraph num="(b)"> <text>If skilled services have been provided, a discharge summary that includes the reason for discharge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An agency that provides care to clients who are assessed as not requiring certified caregivers or skilled services shall maintain a client record, including but not limited to:</text> <paragraph num="(1)"> <text>Nursing assessment;</text> </paragraph> <paragraph num="(2)"> <text>Plan of care;</text> </paragraph> <paragraph num="(3)"> <text>Services provided;</text> </paragraph> <paragraph num="(4)"> <text>Any significant change of condition; and</text> </paragraph> <paragraph num="(5)"> <text>Any other pertinent information regarding the client being served.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An agency shall develop policies and procedures to ensure that all information relating to a client’s condition or preferences, including any significant change of condition as defined in Regulation .02B(27) of this chapter, is documented in the client’s record and communicated in a timely manner to:</text> <paragraph num="(1)"> <text>The client;</text> </paragraph> <paragraph num="(2)"> <text>The client representative, if appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>All appropriate health care professionals and staff who are involved in the development and implementation of the client’s care plan.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Care Notes.</text> <paragraph num="(1)"> <text>Appropriate staff shall write care notes for each client, at a minimum:</text> <paragraph num="(a)"> <text>On admission and at least weekly;</text> </paragraph> <paragraph num="(b)"> <text>Upon any significant changes in the client’s condition; and</text> </paragraph> <paragraph num="(c)"> <text>When the care plan is modified.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agency shall ensure that all notes and reports that are entered in the clinical record, which may include an electronic record, are detailed, legible, chronological, dated, and signed with the name and title of the individual rendering the service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The agency may accept orders for care with an electronic signature. Orders may be received by, but not limited to, mail, hand delivery, or facsimile transmission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Maintenance of Records."> <paragraph num="A."> <text>The agency shall maintain a client’s record for 5 years after the client is discharged. For a client younger than 18 years old, the agency shall maintain the client’s record after discharge until the resident is 21 years old, or for 5 years after the record is made, whichever is later, except as otherwise provided in Health-General Article, §4-403, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>If an agency ceases operation, the agency shall make arrangements to return the records to the client or client representative with legal authority to make health care decisions, or retain the records as required by §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>An agency shall:</text> <paragraph num="(1)"> <text>Maintain the privacy and confidentiality of a client’s medical records;</text> </paragraph> <paragraph num="(2)"> <text>Release medical records or medical information about a client only with the written consent of the client or client representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain and dispose of a client’s medical records in accordance with Health-General Article, Title 4, Subtitle 3 and 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the provisions of §§A—C of this regulation, the agency shall establish and implement procedures that ensure that:</text> <paragraph num="(1)"> <text>Records of discharged clients are completed no later than 30 days after the date of discharge; and</text> </paragraph> <paragraph num="(2)"> <text>Safeguards are in place to protect clinical record information against loss, destruction, or illegal or unauthorized use.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Client’s Rights and Responsibilities."> <paragraph num="A."> <text>The agency shall ensure that agency staff develops and implements written policies and procedures concerning clients’ rights and responsibilities.</text> </paragraph> <paragraph num="B."> <text>The agency shall make the policies and procedures available to clients or client representatives.</text> </paragraph> <paragraph num="C."> <text>The policies and procedures shall ensure that the agency provides the client or client representative with:</text> <paragraph num="(1)"> <text>An estimate of costs associated with the services requested by the client;</text> </paragraph> <paragraph num="(2)"> <text>A statement clarifying the costs that the client or client representative will be responsible for if services are not covered by third-party payors;</text> </paragraph> <paragraph num="(3)"> <text>Fully itemized billing statements, including dates of services and unit charge, to be made available on request of the client or client representative;</text> </paragraph> <paragraph num="(4)"> <text>The name of the caregiver or caregivers referred by the agency to provide the service or services;</text> </paragraph> <paragraph num="(5)"> <text>The name and contact information for the individual who is responsible for supervising the client’s care;</text> </paragraph> <paragraph num="(6)"> <text>The telephone number where a client or the client representative can contact the agency 24 hours a day, 7 days a week regarding care; and</text> </paragraph> <paragraph num="(7)"> <text>Disclosure of any subcontractual relationship with any individual or agency to be assigned or referred to provide care to the client.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Rights.</text> <paragraph num="(1)"> <text>A client of an agency or, if appropriate, the client representative with legal authority to make health care decisions has the right to:</text> <paragraph num="(a)"> <text>Be treated with consideration, respect, and full recognition of the client’s human dignity and individuality;</text> </paragraph> <paragraph num="(b)"> <text>Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;</text> </paragraph> <paragraph num="(c)"> <text>Participate in the development of the client’s care plan and medical treatment;</text> </paragraph> <paragraph num="(d)"> <text>Refuse treatment after the possible consequences of refusing treatment have been fully explained;</text> </paragraph> <paragraph num="(e)"> <text>Privacy;</text> </paragraph> <paragraph num="(f)"> <text>Be free from mental, verbal, sexual, and physical abuse, neglect, involuntary seclusion, and exploitation; and</text> </paragraph> <paragraph num="(g)"> <text>Confidentiality.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A client or client representative has the right to:</text> <paragraph num="(a)"> <text>Make suggestions or complaints, or present grievances on behalf of the client to the agency, government agencies, or other persons without the threat or fear of retaliation;</text> </paragraph> <paragraph num="(b)"> <text>Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the participant may have; and</text> </paragraph> <paragraph num="(c)"> <text>Have access to the procedures for making a complaint to the Office of Health Care Quality, and to:</text> <paragraph num="(i)"> <text>The Adult Protective Services Program of the local department of social services, if the client is an adult; or</text> </paragraph> <paragraph num="(ii)"> <text>The Child Protective Services Program of the local department of social services, if the client is a minor.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Advanced Directives. With the exception of durable medical equipment agencies, an agency shall:</text> <paragraph num="(1)"> <text>Provide information to a client about advance directives and the right to have an advance directive; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain information regarding the client’s advance directives to determine whether the advance directive information has an impact on care provided.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Client Directed Care. The agency shall honor the right of:</text> <paragraph num="(1)"> <text>A cognitively capable adult client, or a client representative with legal authority to make health care decisions, to refuse any portion of planned treatment or other portions of the treatment plan, except where medical contraindications to partial treatment exist; and</text> </paragraph> <paragraph num="(2)"> <text>A cognitively capable adult client to have an individual who is not certified to provide assistance with activities of daily living and treatments of a routine nature if the client signs a waiver of skilled services detailing the potential risks and benefits of waiver as required under Regulation .12D of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Informed Consent. The agency shall provide sufficient information to the client or the client representative to allow the client or the client representative to make an informed decision regarding treatment as required under Regulation .12D of this chapter, including:</text> <paragraph num="(1)"> <text>The purpose and nature of an evaluation or treatment regimen;</text> </paragraph> <paragraph num="(2)"> <text>Alternatives to treatment;</text> </paragraph> <paragraph num="(3)"> <text>Side effects and benefits of a proposed treatment regimen and the alternatives to the treatment;</text> </paragraph> <paragraph num="(4)"> <text>The estimated cost of the treatment and the alternatives; and</text> </paragraph> <paragraph num="(5)"> <text>The right to withdraw from treatment at any time, including the risks associated with withdrawing from treatment.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Client Participation. The agency shall allow a client, or client representative with legal authority to make health care decisions, to accept or reject, at the client’s or client representative’s discretion without fear of retaliation from the agency, any employee, independent contractor, or contractual employee that is referred by the agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Special Requirements for the Provision of Intravenous or Related Therapies."> <paragraph num="A."> <text>This regulation applies to intravenous or related therapy provided in the home.</text> </paragraph> <paragraph num="B."> <text>A provider of intravenous or related therapies shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Specialized intravenous therapies and nutritional support services administered enterally or parenterally shall be considered skilled nursing functions.</text> </paragraph> <paragraph num="D."> <text>Medications.</text> <paragraph num="(1)"> <text>Medications and preparations used in the provision of intravenous or nutritional support shall be obtained from a licensed pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>The agency shall document any adverse reactions associated with the therapy and notify the client’s physician.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Education and Training. When an agency provides intravenous or related therapies, the agency shall provide:</text> <paragraph num="(1)"> <text>Education, training, and written instructions to the client, client representative, or the individual caring for the client before the initiation of treatment, which includes:</text> <paragraph num="(a)"> <text>Feeding formulation or medication preparation;</text> </paragraph> <paragraph num="(b)"> <text>Administration of the therapy;</text> </paragraph> <paragraph num="(c)"> <text>Accessing private care;</text> </paragraph> <paragraph num="(d)"> <text>Equipment maintenance;</text> </paragraph> <paragraph num="(e)"> <text>Recognition of complications of therapy, adverse medication reactions, and equipment malfunctions; and</text> </paragraph> <paragraph num="(f)"> <text>Mechanisms for accessing a clinician during business hours and at any time after hours for questions related to drug therapy, drug administration, or equipment troubleshooting or malfunctions; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Retraining and a review to the client, client representative, or the individual caring for the client as needed or requested.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The agency shall maintain a clinical record for a client receiving intravenous or related therapies, which, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, includes the following:</text> <paragraph num="(1)"> <text>Results of training or retraining of the client, client representative, or the individual caring for the client;</text> </paragraph> <paragraph num="(2)"> <text>Composition, indication for use, role, and mode of administration of feeding formulas or medications; and</text> </paragraph> <paragraph num="(3)"> <text>Summary statement at termination of the intravenous or related therapy which includes the results of therapy, complications, outcome, and disposition of the client.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Special Requirements for the Provision of Ventilator Services."> <paragraph num="A."> <text>A provider of ventilator services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter.</text> </paragraph> <paragraph num="B."> <text>This regulation applies to ventilator services provided in the home, including:</text> <paragraph num="(1)"> <text>Volume ventilation;</text> </paragraph> <paragraph num="(2)"> <text>Pressure ventilation;</text> </paragraph> <paragraph num="(3)"> <text>Emergency back-up power systems;</text> </paragraph> <paragraph num="(4)"> <text>Alarms and troubleshooting equipment;</text> </paragraph> <paragraph num="(5)"> <text>Emergency resuscitation; and</text> </paragraph> <paragraph num="(6)"> <text>All related medical equipment used with the provision of ventilator services, including but not limited to:</text> <paragraph num="(a)"> <text>Nebulizers;</text> </paragraph> <paragraph num="(b)"> <text>Suction equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Oxygen.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Education and Training. When an agency provides ventilator services, the agency shall:</text> <paragraph num="(1)"> <text>Use either a licensed registered nurse or a licensed respiratory care practitioner to supervise the provision of education and training and written instruction to the client, client representative, or individual caring for the client; and</text> </paragraph> <paragraph num="(2)"> <text>Provide retraining and review on a monthly basis, and as frequently as necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Client Record. For a client receiving ventilator services, the agency shall maintain a clinical record, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, that includes the following:</text> <paragraph num="(1)"> <text>An evaluation of use of the ventilator and all related medical equipment by the client, client representative, or individual caring for the client that includes:</text> <paragraph num="(a)"> <text>Training at least monthly on the provision of ventilator services; and</text> </paragraph> <paragraph num="(b)"> <text>Retraining, more frequently as needed, on the provision of ventilator services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A prescription that includes the mode, frequency, and ventilator settings;</text> </paragraph> <paragraph num="(3)"> <text>Respiratory and all specialized services, including the results, complications, and outcomes;</text> </paragraph> <paragraph num="(4)"> <text>Physician orders and pharmacy-dispensed respiratory medications;</text> </paragraph> <paragraph num="(5)"> <text>Evidence that the client, client representative, or individual caring for the client was instructed that medications are to be obtained from a licensed pharmacy; and</text> </paragraph> <paragraph num="(6)"> <text>A discharge summary when a client is no longer receiving ventilator-related services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Special Requirements for the Provision of Home Medical Equipment Services."> <paragraph num="A."> <text>An agency that provides home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Education and Training. When an agency provides home medical equipment services, the agency shall:</text> <paragraph num="(1)"> <text>Ensure that its personnel demonstrate competency in delivering and installing the equipment;</text> </paragraph> <paragraph num="(2)"> <text>Provide education, training, and written instructions to the client, the client representative, or the individual caring for the client on the use of the equipment at the time of installation; and</text> </paragraph> <paragraph num="(3)"> <text>Provide the client, client representative, or the individual caring for the client the telephone number of the agency in the event of equipment failure or emergency.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon request, an agency shall provide the prescribing physician with a copy of the:</text> <paragraph num="(1)"> <text>Qualifications, duties, and responsibilities of agency personnel who deliver the home medical equipment services; and</text> </paragraph> <paragraph num="(2)"> <text>Instructions given to the client and the client’s caregivers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Client Records. The agency shall maintain a client record for each client receiving home medical equipment services in accordance with industry standards, including but not limited to:</text> <paragraph num="(1)"> <text>Physician order for the provision of home medical equipment services;</text> </paragraph> <paragraph num="(2)"> <text>Any significant change of condition;</text> </paragraph> <paragraph num="(3)"> <text>Services provided; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent information regarding the client being served.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An agency shall ensure that the installation, maintenance, repair, and storage of home medical equipment comply with the manufacturer’s specifications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Sanctions."> <paragraph num="A."> <text>If the Secretary determines that an agency has violated this chapter, the Secretary, in addition to the sanctions set forth in Regulations .21—.27 of this chapter may:</text> <paragraph num="(1)"> <text>Restrict the number of clients the agency may serve;</text> </paragraph> <paragraph num="(2)"> <text>Limit the types of clients an agency may serve;</text> </paragraph> <paragraph num="(3)"> <text>Require the licensee, and any of its staff, to receive remedial instruction in a specific area;</text> </paragraph> <paragraph num="(4)"> <text>Require the agency to use the services of a management firm that is approved by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Mandate staffing patterns that specify the number of personnel or personnel qualifications, or both;</text> </paragraph> <paragraph num="(6)"> <text>Direct the licensee to correct the violations in a specific manner or within a specified timeframe;</text> </paragraph> <paragraph num="(7)"> <text>Notify, or require the agency to notify, the client, the client representative, or the family of any client who is affected by the noncompliance;</text> </paragraph> <paragraph num="(8)"> <text>Increase the frequency of monitoring visits during a specified period of time; or</text> </paragraph> <paragraph num="(9)"> <text>Establish certain conditions for continued operation, including time limits for continued operation and for compliance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license.</text> </paragraph> <paragraph num="C."> <text>A licensee aggrieved by the imposition of a sanction under §A(1) or (2) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Civil Money Penalties."> <paragraph num="A."> <text>The Secretary may impose a civil money penalty on an agency if a deficiency or continuing pattern of deficiencies exists in the residential service agency.</text> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty will be imposed, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>Nature, number, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of a continuing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the agency to correct the deficiency or deficiencies; and</text> </paragraph> <paragraph num="(5)"> <text>An agency’s prior history of compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department determines that a deficiency or a continuing pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Permit the agency the opportunity to correct the deficiencies by a specified date;</text> </paragraph> <paragraph num="(2)"> <text>Impose a civil money penalty of up to $1,000 per day until sustained compliance is achieved; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a civil money penalty for each instance of violation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department permits an agency the opportunity to correct the deficiencies by a specific date, and the agency fails to comply with this requirement, the Department may impose a civil penalty of up to $1,000 for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> <paragraph num="E."> <text>If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order is based;</text> </paragraph> <paragraph num="(2)"> <text>Amount of the civil money penalties to be imposed;</text> </paragraph> <paragraph num="(3)"> <text>Manner in which the amount of the civil money penalty was calculated; and</text> </paragraph> <paragraph num="(4)"> <text>Appeal rights.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Amount of Civil Money Penalties."> <paragraph num="A."> <text>A civil money penalty imposed on a person under this chapter may not exceed $10,000 per instance or, as provided in Regulation .21 of this chapter, $1,000 per day.</text> </paragraph> <paragraph num="B."> <text>In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>Nature, number, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(3)"> <text>The efforts made by, and ability of, the agency to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>Whether the amount of the civil money penalty will jeopardize the financial ability of the agency to continue operation as an agency;</text> </paragraph> <paragraph num="(5)"> <text>Prior history of compliance by the agency; and</text> </paragraph> <paragraph num="(6)"> <text>Other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Civil Money Penalties — Hearings."> <paragraph num="A."> <text>A hearing on the appeal shall be held consistent with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the licensee:</text> <paragraph num="(1)"> <text>Informing the licensee of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the licensee of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is suspended by emergency action:</text> <paragraph num="(1)"> <text>The agency shall immediately return the license to the Department;</text> </paragraph> <paragraph num="(2)"> <text>The agency shall immediately stop providing services; and</text> </paragraph> <paragraph num="(3)"> <text>The agency shall notify competent clients and client representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Show Cause Hearing.</text> <paragraph num="(1)"> <text>In addition to the right to request an evidentiary hearing in accordance with Regulation .28 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension before the evidentiary hearing.</text> </paragraph> <paragraph num="(2)"> <text>The show cause hearing shall be held promptly.</text> </paragraph> <paragraph num="(3)"> <text>The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension.</text> </paragraph> <paragraph num="(4)"> <text>The show cause hearing shall be conducted before the Secretary, or a designee of the Secretary, who:</text> <paragraph num="(a)"> <text>Shall determine procedural issues;</text> </paragraph> <paragraph num="(b)"> <text>May impose reasonable time limits on each party’s oral argument; and</text> </paragraph> <paragraph num="(c)"> <text>Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may:</text> <paragraph num="(a)"> <text>Affirm the order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings in accordance with Regulation .28 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the Secretary’s final decision does not uphold the emergency suspension, the agency may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Denial or Revocation of a License."> <text>The Secretary, for cause shown, may deny, revoke, or refuse to reissue any license issued for inability or failure to comply with the regulations of this chapter. This action is subject to the provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Notice to Clients."> <text>Unless otherwise ordered by the Secretary, the agency shall notify each competent client and each client representative within at least 30 days of:</text> <paragraph num="A."> <text>Any significant change of licensure status;</text> </paragraph> <paragraph num="B."> <text>A voluntary surrender of its agency license; or</text> </paragraph> <paragraph num="C."> <text>Denial, revocation, or suspension of the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Penalty for Unlicensed Operation."> <text>A person that operates a residential service agency without a license may be assessed a civil money penalty by the Department not to exceed $10,000 per violation and, additionally, is guilty of a misdemeanor and, on conviction, is subject to a criminal fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense.</text> </regulation> <regulation prefix="Regulation" num=".28" heading="Hearings."> <paragraph num="A."> <text>An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in State Government Article, §10-205, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>An aggrieved party may file exceptions as provided in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 19, Subtitle 4A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 17, 1994 (21:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C repealed effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed and new Regulations .01—.28 adopted effective May 1, 2012 (38:21 Md. R. 1277)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 21, 2015 (42:25 Md. R. 1543); March 28, 2016 (43:6 Md. R. 406)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, I amended effective August 19, 2013 (40:16 Md. R. 1343); January 6, 2014 (40:26 Md. R. 2162); March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H amended effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H, I amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12E amended as an emergency provision effective June 1, 2012 (39:13 Md. R. 784); amended permanently effective September 3, 2012 (39:17 Md. R. 1148)</annotation> </annotations> </chapter> <chapter num="06" heading="Hospital Patient Safety Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to provide a safe environment for patients by requiring hospitals to:</text> <paragraph num="A."> <text>Identify adverse events;</text> </paragraph> <paragraph num="B."> <text>Encourage reporting of near-misses;</text> </paragraph> <paragraph num="C."> <text>Assess and prioritize near-misses and adverse events based on level of disability or potential disability to patients;</text> </paragraph> <paragraph num="D."> <text>Determine the appropriate hospital response based on level of disability or potential disability;</text> </paragraph> <paragraph num="E."> <text>Conduct a root cause analysis of:</text> <paragraph num="(1)"> <text>All level 1 events;</text> </paragraph> <paragraph num="(2)"> <text>All level 2 events; and</text> </paragraph> <paragraph num="(3)"> <text>If warranted, any near-miss or other adverse event;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Conduct an appropriate investigation of adverse events and near-misses that do not require or warrant a root cause analysis;</text> </paragraph> <paragraph num="G."> <text>Provide a process by which the concerns of patients can be addressed; and</text> </paragraph> <paragraph num="H."> <text>Provide a process to notify a patient or, if appropriate, a patient's family, whenever an outcome of care differs significantly from an anticipated outcome.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Action plan” means a written document that includes:</text> <paragraph num="(a)"> <text>Specific measures to correct problems or areas of concerns;</text> </paragraph> <paragraph num="(b)"> <text>Specific measures to address areas of system improvement;</text> </paragraph> <paragraph num="(c)"> <text>Time frames for implementation of any specific measures; and</text> </paragraph> <paragraph num="(d)"> <text>Title of responsible individual to monitor implementation and effectiveness.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Adverse event” means an unexpected occurrence related to an individual's medical treatment and not related to the natural course of the patient's illness or underlying disease condition.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Level 1 adverse event” means an adverse event that results in death or serious disability.</text> </paragraph> <paragraph num="(5)"> <text>“Level 2 adverse event” means an adverse event that requires a medical intervention to prevent death or serious disability.</text> </paragraph> <paragraph num="(6)"> <text>“Level 3 adverse event” means an adverse event that does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability.</text> </paragraph> <paragraph num="(7)"> <text>“Medical review committee” has the meaning stated in Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Near-miss” means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention.</text> </paragraph> <paragraph num="(9)"> <text>“Patient safety program” means an ongoing, proactive program for identifying risks to patient safety and reducing medical errors which is one component of the hospital-wide risk management program.</text> </paragraph> <paragraph num="(10)"> <text>“Root cause analysis” means a medical review committee process as defined under Health Occupations Article, §1-401, Annotated Code of Maryland, for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or near-misses.</text> </paragraph> <paragraph num="(11)"> <text>“Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still is present at the time of discharge.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Patient Safety Program."> <paragraph num="A."> <text>General. On or before March 15, 2004, a hospital shall have in effect a patient safety program that meets the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Duties of the Hospital.</text> <paragraph num="(1)"> <text>The hospital shall identify an individual as patient safety coordinator who shall:</text> <paragraph num="(a)"> <text>Coordinate patient safety activities;</text> </paragraph> <paragraph num="(b)"> <text>Facilitate assessment and determination of the appropriate response to reported near-misses and adverse events related to patient care;</text> </paragraph> <paragraph num="(c)"> <text>Monitor root cause analyses and any actions resulting from a root cause analysis; and</text> </paragraph> <paragraph num="(d)"> <text>Provide for flow of information among quality assurance, credentialing, peer review, and any patient safety committee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital shall establish:</text> <paragraph num="(a)"> <text>Patient safety education programs for all staff; and</text> </paragraph> <paragraph num="(b)"> <text>An internal staff committee structure in accordance with Health Occupations Article, §1-401, Annotated Code of Maryland to conduct a review and evaluation of patient safety activities in accordance with this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The governing board of a hospital shall develop a process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program.</text> </paragraph> <paragraph num="(4)"> <text>Before a committee may operate or review patient safety activities under this chapter, a hospital shall require that the committee meet the requirements for a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Near-Miss and Adverse Event Reporting and Determination of Appropriate Response."> <paragraph num="A."> <text>The hospital shall develop and encourage a supportive environment that permits spontaneous identification, open discussion, and timely and accurate reporting of near-misses and adverse events.</text> </paragraph> <paragraph num="B."> <text>The hospital shall establish a clear and well-defined near-miss and adverse event identification and reporting process that shall:</text> <paragraph num="(1)"> <text>Encourage reporting of near-misses and require reporting of adverse events;</text> </paragraph> <paragraph num="(2)"> <text>List and describe examples of adverse events that shall be reported;</text> </paragraph> <paragraph num="(3)"> <text>Designate a hospital representative to whom a near-miss is encouraged to be reported or to whom an adverse event shall be reported;</text> </paragraph> <paragraph num="(4)"> <text>Provide a time frame within which the near-miss is encouraged to be reported or within which an adverse event shall be reported;</text> </paragraph> <paragraph num="(5)"> <text>Require that an individual employed by the hospital or appointed to the medical staff and who is aware of an adverse event shall report the adverse event in accordance with this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Develop a procedure to coordinate receipt of all adverse events and near-misses and to prioritize adverse events and near-misses based on level of disability or potential disability; and</text> </paragraph> <paragraph num="(7)"> <text>Develop a procedure to assign an appropriate response to level 1 and level 2 adverse events, other adverse events, and near-misses.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedures for Level 1 and 2 Adverse Events and Certain Near-Misses."> <paragraph num="A."> <text>When a level 1 or 2 adverse event, or a near-miss that warrants a root cause analysis occurs, the hospital shall:</text> <paragraph num="(1)"> <text>Provide immediate care to the patient;</text> </paragraph> <paragraph num="(2)"> <text>Identify any immediate corrective action to prevent reoccurrence;</text> </paragraph> <paragraph num="(3)"> <text>Identify and report the event in accordance with the hospital's reporting process;</text> </paragraph> <paragraph num="(4)"> <text>Complete a root cause analysis within 60 days of the time that the hospital has knowledge of the occurrence;</text> </paragraph> <paragraph num="(5)"> <text>Develop and implement an action plan to correct any systems problems;</text> </paragraph> <paragraph num="(6)"> <text>Share any pertinent information with quality assurance or other medical review committees; and</text> </paragraph> <paragraph num="(7)"> <text>Aggregate data to determine patterns or trends.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All patient safety activities shall be conducted by a medical review committee established under Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Root Cause Analysis."> <paragraph num="A."> <text>The hospital shall appoint an interdisciplinary root cause analysis team that shall include:</text> <paragraph num="(1)"> <text>Individuals who have knowledge of the event or near-miss;</text> </paragraph> <paragraph num="(2)"> <text>Representatives of hospital leadership; and</text> </paragraph> <paragraph num="(3)"> <text>Individuals with expertise in the subject matter of the event.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to participate in the root cause analysis as appropriate.</text> </paragraph> <paragraph num="C."> <text>The root cause analysis shall examine the cause and effect of the event through an impartial process by:</text> <paragraph num="(1)"> <text>Analysis of human and other factors;</text> </paragraph> <paragraph num="(2)"> <text>Analysis of related processes and systems;</text> </paragraph> <paragraph num="(3)"> <text>Analysis of underlying cause and effect systems through a series of “why” questions;</text> </paragraph> <paragraph num="(4)"> <text>Identification of risks and possible contributing factors; and</text> </paragraph> <paragraph num="(5)"> <text>Determination of improvement in processes or systems.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A root cause analysis shall:</text> <paragraph num="(1)"> <text>Be internally consistent; and</text> </paragraph> <paragraph num="(2)"> <text>Include consideration of relevant literature and best practices.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital shall provide feedback including changes to hospital policy or procedure resulting from the root cause analysis to hospital employees and staff who were involved in the event or near-miss and to other employees or staff who would benefit from the feedback.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Level 3 Adverse Events and Certain Near-Misses."> <paragraph num="A."> <text>If the event is not a level 1 or 2 event or a near-miss that warrants a root cause analysis, the hospital shall conduct an evaluation of the event to determine any problem area and corrective action.</text> </paragraph> <paragraph num="B."> <text>All events shall be aggregated by type and level to determine any patterns or trends.</text> </paragraph> <paragraph num="C."> <text>The hospital is encouraged to evaluate and trend all near-misses to determine any system problems.</text> </paragraph> <paragraph num="D."> <text>The hospital shall monitor the results and effectiveness of all action plans.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Information Sharing."> <text>The patient safety program shall require that the quality assurance and other medical review committees share information and take any appropriate action concerning near-misses and adverse events.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Reports to the Department."> <paragraph num="A."> <text>A hospital shall report any level 1 adverse event to the Department within 5 days of the hospital's knowledge that the event occurred.</text> </paragraph> <paragraph num="B."> <text>A hospital shall submit the root cause analysis and action plan for the level 1 adverse event to the Department within 60 days of the hospital's knowledge of the occurrence.</text> </paragraph> <paragraph num="C."> <text>Any root cause analysis and any other medical review committee information submitted to the Department and the identity of individuals appointed to the interdisciplinary root cause analysis team are confidential under Health Occupations Article, §1-401, Annotated Code of Maryland and are not discoverable, disclosable, or admissible as evidence in any civil action or available under the Maryland Public Information Act.</text> </paragraph> <paragraph num="D."> <text>If the Department receives a complaint alleging a level 1 adverse event, the Department may accept the root cause analysis as a hospital's internal investigation under Health-General Article, §19-309(b), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Documentation."> <text>Actions taken by the quality assurance and medical staff credentialing and peer review committees shall be documented in committee minutes.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Patient Complaint Program."> <paragraph num="A."> <text>In accordance with this regulation, the patient safety program shall include a formal written program for addressing patient complaints.</text> </paragraph> <paragraph num="B."> <text>The hospital shall provide patients with information regarding the hospital's patient complaint program including:</text> <paragraph num="(1)"> <text>The name of the hospital's representative that the patient may contact if the patient wishes to make a complaint; and</text> </paragraph> <paragraph num="(2)"> <text>The hospital representative's phone number or address.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospital's representative shall treat the complainant with dignity and courtesy and due regard for the individual's privacy.</text> </paragraph> <paragraph num="D."> <text>The hospital's representative shall provide the complainant with information about the complaint including:</text> <paragraph num="(1)"> <text>The hospital representative that the patient may contact for information regarding the complaint;</text> </paragraph> <paragraph num="(2)"> <text>The procedure for investigating the complaint;</text> </paragraph> <paragraph num="(3)"> <text>The length of time in which the complainant can expect a response or resolution to the complaint; and</text> </paragraph> <paragraph num="(4)"> <text>Notice that the patient may contact the Department at a specified telephone number or address with any complaint.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital's representative shall document the complaint and any action taken concerning the complaint or the hospital function complained about.</text> </paragraph> <paragraph num="F."> <text>Patient Safety Program Requirement—Notice to Patients and Families of Unanticipated Outcomes. The hospital shall inform the patient and, if appropriate, the patient's family whenever a final outcome of care differs significantly from an anticipated outcome.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Interhospital Notification Of Level 1 or Level 2 Adverse Events."> <paragraph num="A."> <text>A hospital that admits a patient with a condition resulting from a level 1 or level 2 adverse event that the hospital perceives may be related to care that was provided at another Maryland hospital and that appears to be unknown to the other hospital at the time of discharge shall notify and provide any necessary information to the appropriate medical review committee at the hospital where the adverse event allegedly occurred.</text> </paragraph> <paragraph num="B."> <text>The hospital where the event allegedly occurred shall conduct a root cause analysis and provide notice to the Department in accordance with this chapter.</text> </paragraph> <paragraph num="C."> <text>The hospital where the event allegedly occurred shall notify the patient or the patient's family in accordance with this chapter.</text> </paragraph> <paragraph num="D."> <text>All communication that occurs in accordance with §§A—B of this regulation is confidential under Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Records."> <text>The hospital shall maintain records that document the operation of its patient safety program.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Documentation."> <paragraph num="A."> <text>On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes:</text> <paragraph num="(1)"> <text>The name of the patient safety coordinator;</text> </paragraph> <paragraph num="(2)"> <text>The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program;</text> </paragraph> <paragraph num="(3)"> <text>A description of the near-miss and adverse event identification and reporting process;</text> </paragraph> <paragraph num="(4)"> <text>A list of examples of adverse events that shall be reported;</text> </paragraph> <paragraph num="(5)"> <text>A description of the process for determining which near-misses warrant a root cause analysis to be conducted;</text> </paragraph> <paragraph num="(6)"> <text>A description of the near-miss and adverse event review, prioritization, evaluation, and root cause analysis process;</text> </paragraph> <paragraph num="(7)"> <text>A description of the process used to provide notification to a patient, and, if appropriate, to a patient's family whenever an outcome of care differs from an anticipated outcome; and</text> </paragraph> <paragraph num="(8)"> <text>A description of the formal written patient complaint process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall notify the Secretary of any change in its patient safety program related to the description required by this regulation within 30 days of the effective date of the change.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Plan of Correction."> <paragraph num="A."> <text>If the Department notifies a hospital that the patient safety program of the hospital does not meet the requirements of this chapter, the hospital shall submit a plan indicating the steps the hospital shall take to meet the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The plan shall be sent to the Secretary within 10 days after the Department notifies the hospital that the hospital does not meet the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Penalties."> <text>If a hospital fails to have in effect a patient safety program in accordance with this chapter, then the Secretary may impose on the hospital the following penalties:</text> <paragraph num="A."> <text>Revocation of the hospital's license; or</text> </paragraph> <paragraph num="B."> <text>A fine of $500 for each day that the hospital is in violation of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Departmental Obligations."> <text>The Department shall:</text> <paragraph num="A."> <text>Provide feedback to hospitals regarding submitted root cause analyses within 60 days of receipt; and</text> </paragraph> <paragraph num="B."> <text>Release an annual public report containing a compilation of de-identified data regarding the type and outcomes of reported adverse events.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-308 and 19-319, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 15, 2004 (31:5 Md. R. 448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective February 26, 2018 (45:4 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective February 26, 2018 (45:4 Md. R. 206)</annotation> </annotations> </chapter> <chapter num="07" heading="Nursing Referral Service Agencies"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to set minimum standards for licensure of nursing referral service agencies in Maryland. This chapter does not preclude a nursing referral service agency from operating with independent contractors.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means normal daily activities including:</text> <paragraph num="(a)"> <text>Bathing, toileting, and personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>Dressing;</text> </paragraph> <paragraph num="(c)"> <text>Meal preparation and eating;</text> </paragraph> <paragraph num="(d)"> <text>Companionship; and</text> </paragraph> <paragraph num="(e)"> <text>Assistance with physical transfer and ambulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Agency” means a licensed nursing referral service agency as defined in §B(8) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>“Care provider” means an individual who provides health care services and assistance to a client in the activities of daily living including:</text> <paragraph num="(a)"> <text>Bathing, toileting, and personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>Dressing;</text> </paragraph> <paragraph num="(c)"> <text>Meal preparation and eating;</text> </paragraph> <paragraph num="(d)"> <text>Companionship; and</text> </paragraph> <paragraph num="(e)"> <text>Assistance in physical transfer and ambulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Home health aid services” means personal and health care services delivered to a client by a care provider.</text> </paragraph> <paragraph num="(6)"> <text>“License” means a document issued by the Secretary to a person to operate a nursing referral service agency in Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed or certified health professional” means an individual who is licensed or certified under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in this State.</text> </paragraph> <paragraph num="(8)"> <text>“Licensee” means a person to whom a license is issued by the Secretary to operate a nursing referral service agency.</text> </paragraph> <paragraph num="(9)"> <text>“Nursing referral service agency” means one or more individuals engaged in the business of screening and referring, directly or in accordance with contractual arrangements that may include independent contractors, licensed health professionals or care providers to clients for the provision of nursing services, home health aid services, or other home health care services at the request of the client.</text> </paragraph> <paragraph num="(10)"> <text>“Residence” means a place where an individual resides and may include a private home, a nursing facility, an assisted living program, or other type of residential unit.</text> </paragraph> <paragraph num="(11)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person, partnership, corporation, association, or other business entity may not conduct, operate, or maintain a nursing referral service agency in this State before being licensed by the Secretary.</text> </paragraph> <paragraph num="B."> <text>This chapter does not limit the right of any person who holds a license issued under Health-General Article or Health Occupations Article, Annotated Code of Maryland, to act as authorized by that license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedures."> <paragraph num="A."> <text>Application for License.</text> <paragraph num="(1)"> <text>A person desiring to conduct, operate, or maintain a nursing referral service agency in this State shall file an application with the Secretary, on the written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>The application for licensure shall contain the name and address of each officer and the director of the nursing referral service agency.</text> </paragraph> <paragraph num="(3)"> <text>Along with the application, the applicant shall submit a:</text> <paragraph num="(a)"> <text>Nonrefundable 3-year license fee of $1,000 payable to the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Copy of the agency's policies and procedures as specified in Regulation .08B(1) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Requirements. The applicant shall:</text> <paragraph num="(1)"> <text>Demonstrate compliance with all applicable federal, State, and local laws and regulations; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain records to support compliance with the regulations of this chapter and make the records available to the Department upon request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After reviewing the application for licensure, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application and issue a 3-year license to the applicant if the applicant complies with all requirements of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Deny the application if the applicant does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A 3-year license expires 3 years from the date of its issuance, unless it is otherwise revoked or suspended by the Department.</text> </paragraph> <paragraph num="E."> <text>License Renewal.</text> <paragraph num="(1)"> <text>The agency shall file an application for relicensure on the written or electronic form provided by the Secretary at least 60 days before the expiration of its current license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall submit to the Department:</text> <paragraph num="(a)"> <text>An application for license renewal;</text> </paragraph> <paragraph num="(b)"> <text>A nonrefundable license renewal fee of $1,000 payable to the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Updates, if any, to the agency's policies and procedures as specified in Regulation .08B(1) of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Posting Of License."> <text>A nursing referral service agency shall post its license conspicuously onsite so that it is clearly visible to the general public.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Restrictions on a License."> <paragraph num="A."> <text>A licensee may not, under any circumstances, transfer or reassign its nursing referral service agency license to another person.</text> </paragraph> <paragraph num="B."> <text>If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspections by the Secretary of Health."> <paragraph num="A."> <text>An applicant or a licensee shall maintain records to support compliance with this chapter and ensure that all records are open to inspection by the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant or a licensee shall assist the Department in conducting an inspection if the Department determines that the assistance is necessary to enable the Department to conduct the inspection.</text> </paragraph> <paragraph num="C."> <text>If the Department issues deficiencies after an inspection, an agency shall submit a written plan of correction to the Department within 10 business days of receiving the Department's notice of deficiencies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Administration."> <paragraph num="A."> <text>Contractual Arrangements. The regulations of this chapter do not preclude a nursing referral service agency from operating with independent contractors.</text> </paragraph> <paragraph num="B."> <text>Agency Referrals. An agency shall:</text> <paragraph num="(1)"> <text>Develop and implement policies and procedures to screen licensed or certified health professionals and care providers that include the following:</text> <paragraph num="(a)"> <text>A State criminal history records check or a private agency background check in accordance with Health-General Article, §19-4B-03(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Verification of current professional licensure or certification under the Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A basic health screening including tuberculosis screening;</text> </paragraph> <paragraph num="(d)"> <text>Verification of references;</text> </paragraph> <paragraph num="(e)"> <text>Verification of employment history;</text> </paragraph> <paragraph num="(f)"> <text>Completion of I-9 forms; and</text> </paragraph> <paragraph num="(g)"> <text>An in-person interview of a licensed or certified health professional and care provider before any referral of the individual is made to a client; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Disclose to the client or the client's representative whether or not the agency has made a determination that the referral is appropriate to the needs of a client and is in compliance with applicable titles of Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Complaint Process.</text> <paragraph num="(1)"> <text>An agency shall institute an internal client complaint investigation process that includes:</text> <paragraph num="(a)"> <text>Notice to the client or the client's representative of the complaint process; and</text> </paragraph> <paragraph num="(b)"> <text>Protocols to investigate complaints.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An agency shall provide notice to clients of the Department's complaint hotline number for complaints about services provided by an individual that is referred by the agency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Client Participation. An agency shall allow clients to accept or reject, at their discretion, any licensed or certified health professional or care provider that is referred by the agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Sanctions."> <paragraph num="A."> <text>The Secretary may deny, suspend, revoke, or refuse to reissue any license for inability or failure to comply with this chapter. Any action taken to deny, suspend, or refuse to issue a license is subject to provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary, in addition to or instead of the sanctions set forth in §A of this regulation may direct the licensee to establish certain conditions for continued operation, including time limits for compliance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Penalty for Unlicensed Operation."> <text>A person that operates a nursing referral services agency without a license is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, Subtitle 19-4B, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, E amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="08" heading="Freestanding Medical Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited hospital” means a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations.</text> </paragraph> <paragraph num="(2)"> <text>“ACEP” means the American College of Emergency Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Affiliated hospital” means a hospital that operates and provides ancillary and support services to the freestanding medical facility.</text> </paragraph> <paragraph num="(4)"> <text>“Certified medical radiation technologist” means an individual who is certified by the Board of Physicians to practice medical radiation technology in this State.</text> </paragraph> <paragraph num="(5)"> <text>“Credentialing process” means the process by which a hospital:</text> <paragraph num="(a)"> <text>Verifies qualifications of a physician;</text> </paragraph> <paragraph num="(b)"> <text>Delineates clinical privileges of a physician; and</text> </paragraph> <paragraph num="(c)"> <text>Monitors performance of a physician.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity including severe pain, psychiatric disturbances, and symptoms of substance abuse such that the absence of immediate medical attention could result in:</text> <paragraph num="(a)"> <text>Placing the health of the individual in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Placing the health of a pregnant woman or unborn child in serious jeopardy;</text> </paragraph> <paragraph num="(c)"> <text>Serious impairment to any bodily function;</text> </paragraph> <paragraph num="(d)"> <text>Serious dysfunction of any bodily organ or part; or</text> </paragraph> <paragraph num="(e)"> <text>With respect to a pregnant woman who is having contractions:</text> <paragraph num="(i)"> <text>Inadequate time to effect a safe transfer to another hospital before delivery; or</text> </paragraph> <paragraph num="(ii)"> <text>The transfer posing a threat to the health or safety of the woman or the unborn child.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Freestanding medical facility” means a facility:</text> <paragraph num="(a)"> <text>In which medical and health services are provided;</text> </paragraph> <paragraph num="(b)"> <text>That is physically separated from a hospital or hospital grounds; and</text> </paragraph> <paragraph num="(c)"> <text>That is an administrative part of a hospital or related institution.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Hospital” means an institution that:</text> <paragraph num="(a)"> <text>Has a group of at least five physicians who are organized as a medical staff for the institution;</text> </paragraph> <paragraph num="(b)"> <text>Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Admits or retains the individuals for overnight care.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Joint Commission on Accreditation of Healthcare Organizations” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97.</text> </paragraph> <paragraph num="(11)"> <text>“License” means a document issued by the Secretary to operate a freestanding emergency medical facility in this State.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed independent practitioner” means any individual permitted by law and by the facility to provide care and services without direction or supervision within the scope of the individual's license and consistent with individually granted clinical privileges.</text> </paragraph> <paragraph num="(13)"> <text>“Physician” means an individual who is licensed by the Board of Physicians to practice medicine in this State.</text> </paragraph> <paragraph num="(14)"> <text>“Registered nurse” means an individual who is licensed by the Board of Nursing to practice registered nursing in this State.</text> </paragraph> <paragraph num="(15)"> <text>“Related institution” means a facility as defined under Health-General Article, §19-301(o), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>Interhospital Transfer Guidelines Manual; Maryland Institute for Emergency Medical Services Systems, Baltimore, Maryland (January 2002).</text> </paragraph> <paragraph num="(2)"> <text>ACEP Policy Statement: Emergency Department Planning and Resources Guidelines (June 2004), American College of Emergency Physicians, PO Box 619911, Dallas, Texas 75261-9911.</text> </paragraph> <paragraph num="(3)"> <text>Guidelines for Design and Construction of Hospital and Healthcare Facilities, 2001 Edition, American Institute of Architects, 1735 New York Avenue, N.W., Washington D.C. 20006, which is incorporated in COMAR 10.07.01.03.</text> </paragraph> <paragraph num="(4)"> <text>Hospital Accreditation Standards, 2006 Edition, Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd, Oakbrook Terrace, Illinois 60181, which is incorporated in COMAR 10.07.01.09.</text> </paragraph> <paragraph num="(5)"> <text>U.S. Centers for Disease Control and Prevention Guidelines for Standard Precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard 29 CFR §1910.1030 which is incorporated by reference in COMAR 09.12.31.</text> </paragraph> <paragraph num="(6)"> <text>The Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Restrictions."> <text>A freestanding medical facility may not use the name “emergency room”, “emergency department”, or “hospital” in its title or advertisements or on any signage.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure Application Procedure."> <paragraph num="A."> <text>A hospital may not establish, operate, or continue to operate an existing freestanding medical facility without first obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>A hospital desiring to establish a freestanding medical facility shall apply to the Department for initial licensure on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="C."> <text>The application shall state the name of the affiliated accredited hospital.</text> </paragraph> <paragraph num="D."> <text>The application shall be accompanied by a nonrefundable 3-year license fee of $3,000.</text> </paragraph> <paragraph num="E."> <text>The Secretary shall issue a license to a freestanding medical facility for a term of 3 years if the facility complies with all licensing requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewal of License."> <paragraph num="A."> <text>A licensee shall file an application for license renewal with the Secretary on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="B."> <text>A licensed freestanding medical facility shall apply for licensure within 60 days of the expiration date of its current license.</text> </paragraph> <paragraph num="C."> <text>The application fee for license renewal shall be accompanied by a nonrefundable 3-year license renewal fee of $2,000.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inspections."> <paragraph num="A."> <text>A freestanding medical facility shall be open to inspection at all times by the Department for annual licensure surveys, revisit surveys, and complaint investigations.</text> </paragraph> <paragraph num="B."> <text>Licensure Standards. When conducting a licensure or complaint survey, the Department shall use this chapter as well as the:</text> <paragraph num="(1)"> <text>Joint Commission on Accreditation of Healthcare Organization, 2006 Hospital Accreditation Standards;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.07.06;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.07.01.24, .26 and .33; and</text> </paragraph> <paragraph num="(4)"> <text>ACEP Policy Statement: Emergency Department Planning and Resources Guidelines.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Responsibility of the Freestanding Medical Facility. The facility shall make the following documents available for review by the Department:</text> <paragraph num="(1)"> <text>Policies and procedures;</text> </paragraph> <paragraph num="(2)"> <text>Minutes of committee meetings; and</text> </paragraph> <paragraph num="(3)"> <text>Data and documentation related to oversight of the freestanding medical facility at the affiliated hospital.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Waiver."> <paragraph num="A."> <text>Facilities that are providing services on or before February 12, 2007, but do not meet all requirements of this chapter, may request a waiver of specific requirements from the Department.</text> </paragraph> <paragraph num="B."> <text>All other freestanding medical facilities seeking a waiver from this chapter shall submit a request to the Department including the rationale for the waiver and alternatives to the requirement based on clinical and technical advances.</text> </paragraph> <paragraph num="C."> <text>In its request, the facility shall demonstrate that a waiver of the requirement would:</text> <paragraph num="(1)"> <text>Not pose a threat to patients or the provision of services; and</text> </paragraph> <paragraph num="(2)"> <text>Be a financial hardship for the facility to comply with that requirement.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall review the request for a waiver and notify the freestanding medical facility of its determination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Affiliated Hospitals."> <paragraph num="A."> <text>The freestanding medical facility shall be reviewed under the affiliated hospital's accreditation by the Joint Commission on Accreditation of Healthcare Organizations.</text> </paragraph> <paragraph num="B."> <text>The governing body of the affiliated hospital shall provide administrative and clinical oversight for the care and services provided by the freestanding medical facility. Services of the facility shall be reviewed and monitored consistent with the hospital's bylaws, including but not limited to:</text> <paragraph num="(1)"> <text>Patient safety;</text> </paragraph> <paragraph num="(2)"> <text>Peer review;</text> </paragraph> <paragraph num="(3)"> <text>Medical staff;</text> </paragraph> <paragraph num="(4)"> <text>Risk management; and</text> </paragraph> <paragraph num="(5)"> <text>Quality improvement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may issue a waiver for the requirement for accreditation if the affiliated hospital is not accredited or if the hospital is actively seeking accreditation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Treatment of Patients."> <text>Regardless of a patient's medical condition, insurance status, or ability to pay, the freestanding medical facility shall provide stabilizing treatment to a patient presenting with an emergency medical condition.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Personnel."> <paragraph num="A."> <text>Administrative Director. The freestanding medical facility shall have a full-time administrative director who:</text> <paragraph num="(1)"> <text>Acts as a liaison with the affiliated hospital;</text> </paragraph> <paragraph num="(2)"> <text>Directs the daily operation of the facility; and</text> </paragraph> <paragraph num="(3)"> <text>Ensures that employees are capable of providing:</text> <paragraph num="(a)"> <text>Resuscitation;</text> </paragraph> <paragraph num="(b)"> <text>Stabilization;</text> </paragraph> <paragraph num="(c)"> <text>Timely triage; and</text> </paragraph> <paragraph num="(d)"> <text>Appropriate transfer of all patients; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ensures that there is an organized and structured patient safety and quality improvement program to monitor and improve patient care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director. The facility shall have a Medical Director who is:</text> <paragraph num="(1)"> <text>A licensed physician; and</text> </paragraph> <paragraph num="(2)"> <text>Board certified or Board eligible in Emergency Medicine by the:</text> <paragraph num="(a)"> <text>American College of Emergency Physicians;</text> </paragraph> <paragraph num="(b)"> <text>American Board of Emergency Medicine; or</text> </paragraph> <paragraph num="(c)"> <text>American Osteopathic Board of Emergency Medicine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Medical Director shall provide clinical oversight of the freestanding medical facility.</text> </paragraph> <paragraph num="D."> <text>Other Personnel. The freestanding medical facility shall be staffed at all times with a:</text> <paragraph num="(1)"> <text>Minimum of one physician who is trained in emergency medicine;</text> </paragraph> <paragraph num="(2)"> <text>Sufficient number of registered nurses and other professionals to provide advanced life support;</text> </paragraph> <paragraph num="(3)"> <text>Certified medical radiation technologist; and</text> </paragraph> <paragraph num="(4)"> <text>Laboratory technician.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A freestanding medical facility shall be staffed during all hours of operation by licensed independent practitioners, nurses, and ancillary health care professionals with the certification, experience, competencies, and skills necessary for providing basic and advanced life support for children and adults.</text> </paragraph> <paragraph num="F."> <text>Credentialing. Physicians and other licensed independent practitioners shall be credentialed consistent with COMAR 10.07.01.24.</text> </paragraph> <paragraph num="G."> <text>The facility shall assess its staffing pattern on a regular basis. Staffing patterns shall accommodate the potential for the unexpected arrival of additional patients. The facility shall have a plan for the provision of additional licensed independent practitioners and nurses in times of acute overload.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Quality Assurance."> <paragraph num="A."> <text>The freestanding medical facility shall develop and implement a quality assurance program.</text> </paragraph> <paragraph num="B."> <text>The quality assurance program shall have a quality management process that:</text> <paragraph num="(1)"> <text>Is multidisciplinary;</text> </paragraph> <paragraph num="(2)"> <text>Is integrated into the hospital's overall quality management program that is reported to the hospital's governing body;</text> </paragraph> <paragraph num="(3)"> <text>Has a structure to ensure that defined program outcomes and performance measures are developed and monitored regularly;</text> </paragraph> <paragraph num="(4)"> <text>Maintains sufficient documentation to:</text> <paragraph num="(a)"> <text>Verify problems;</text> </paragraph> <paragraph num="(b)"> <text>Identify opportunities for improvement; and</text> </paragraph> <paragraph num="(c)"> <text>Show corrective actions taken and resolution of problems;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Includes review of morbidity and mortality; and</text> </paragraph> <paragraph num="(6)"> <text>Evaluates medical care, nursing care, utilization review, tissue review, and pre-hospital care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Laboratory Services."> <paragraph num="A."> <text>The freestanding medical facility shall have on-site laboratory services that are available during the facility's hours of operation.</text> </paragraph> <paragraph num="B."> <text>Laboratory Licensure Standards. The facility's laboratory services shall be licensed consistent with:</text> <paragraph num="(1)"> <text>COMAR 10.10.01;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.10.02;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.10.03;</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.10.04;</text> </paragraph> <paragraph num="(5)"> <text>COMAR 10.10.05;</text> </paragraph> <paragraph num="(6)"> <text>COMAR 10.10.06;</text> </paragraph> <paragraph num="(7)"> <text>COMAR 10.10.07; and</text> </paragraph> <paragraph num="(8)"> <text>COMAR 10.10.08.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Laboratory services shall include the “Suggested Laboratory Capabilities”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 13.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Radiology Services."> <paragraph num="A."> <text>The freestanding medical facility's radiology services shall comply with all State and federal requirements for licensure.</text> </paragraph> <paragraph num="B."> <text>Radiology services shall be available on site at all times that the facility is open for business consistent with “Radiological, Imaging, and Other Diagnostic Services”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 12, except for the sections related to Nuclear Medicine, Radiographic Services, and Vascular/flow Studies including impedance plethysmography.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Pharmacy Services."> <paragraph num="A."> <text>Pharmacy services for freestanding medical facility patients may be provided by:</text> <paragraph num="(1)"> <text>The facility's affiliated hospital; or</text> </paragraph> <paragraph num="(2)"> <text>A contracted pharmacy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The freestanding medical facility that does not have 24-hour a day, 7-day a week outpatient pharmacy services, shall provide its patients with a list of community pharmacies that offer service 24-hours per day.</text> </paragraph> <paragraph num="C."> <text>The facility's pharmacy services shall be provided and operated consistent with all applicable State and federal laws.</text> </paragraph> <paragraph num="D."> <text>The freestanding medical facility shall maintain a supply of medications consistent with the “Suggested Pharmacological and Therapeutic Drugs for Emergency Departments”, ACEP Policy Statement Emergency Department Planning and Resources Guidelines, Page 11.</text> </paragraph> <paragraph num="E."> <text>The facility shall ensure that all drugs and pharmaceuticals are stored securely and maintained within the acceptable level of humidity and temperature.</text> </paragraph> <paragraph num="F."> <text>Data and other information about quality oversight of the pharmacy services shall be available to the Department for review and monitoring.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Access to Emergency Medical Services."> <text>An emergency medical facility shall meet the requirements of the Maryland Institute for Emergency Medical Services Systems to be eligible to accept patients through the Emergency Medical System.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Transfer of Patients."> <paragraph num="A."> <text>The freestanding medical facility shall have pre-arranged transfer agreements with facilities that are capable of providing definitive care appropriate for the nature and severity of the patient's illness or injury.</text> </paragraph> <paragraph num="B."> <text>Patient transfers shall be consistent with the Interhospital Transfer Guidelines published by the Maryland Institute for Emergency Medical Services System.</text> </paragraph> <paragraph num="C."> <text>When transfer by ambulance is medically necessary the facility shall transfer the patient via:</text> <paragraph num="(1)"> <text>A hospital owned and operated ambulance service;</text> </paragraph> <paragraph num="(2)"> <text>A contracted ambulance service; or</text> </paragraph> <paragraph num="(3)"> <text>An ambulance service through an agreement with the local emergency medical system (EMS) jurisdictional program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The level of care and medical interventions provided by an ambulance during transfer shall be appropriate for the patient's condition.</text> </paragraph> <paragraph num="E."> <text>Before transfer, the patient shall:</text> <paragraph num="(1)"> <text>Be assessed by a physician or licensed independent practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>Receive stabilizing medical treatment consistent with that of the freestanding medical facility's ability to treat.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The freestanding medical facility shall provide the emergency medical system and the receiving facility with the patient's medical records necessary for ongoing care, including:</text> <paragraph num="(1)"> <text>All treatment provided to the patient;</text> </paragraph> <paragraph num="(2)"> <text>Medications administered to the patient;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic procedures performed for the patient; and</text> </paragraph> <paragraph num="(4)"> <text>The patient's response to the care at the time of transfer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Medical Records."> <paragraph num="A."> <text>The freestanding medical facility shall ensure that staff members develop a legible and appropriate medical record for each patient who visits the facility for treatment.</text> </paragraph> <paragraph num="B."> <text>Security and Disclosure of Medical Information. The freestanding medical facility shall:</text> <paragraph num="(1)"> <text>Maintain records in a secure manner that protects the confidentiality of patient information at all times;</text> </paragraph> <paragraph num="(2)"> <text>Develop and implement policies and procedures for disclosure of patient medical records and patient access to their medical records, including the costs for retrieving and copying records as defined in Health-General Article, §§4-301— 4-309, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Make medical records available to emergency medical services agencies for outcome data as directed by the Maryland Institute for Emergency Medical Services System.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Retention. The medical record shall be retained as required by all federal and State laws and regulations and shall be made available promptly to the freestanding medical facility staff.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Nourishing Snacks."> <text>A freestanding medical facility shall maintain a supply of nourishing snacks for patients who may require them. The facility shall provide appropriate storage facilities, including refrigeration for the nourishing snacks.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Infection Control."> <text>The freestanding medical facility shall comply with the U.S. Centers for Disease Control and Prevention guidelines for standard precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard, except in a life-threatening emergency in which compliance is not feasible or practicable.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Equipment and Supplies."> <text>The freestanding medical facility shall have equipment and supplies available consistent with the “Suggested Equipment and Supplies for Emergency Departments,” ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, pages 7—10.</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Physical Environment."> <paragraph num="A."> <text>Construction and Zoning. The freestanding medical facility shall comply with the following construction and zoning requirements:</text> <paragraph num="(1)"> <text>All federal, State, and local building, construction and zoning laws; and</text> </paragraph> <paragraph num="(2)"> <text>“Guidelines for Design and Construction of Hospital and Healthcare Facilities, (2001 Edition),” Section 9.6 Freestanding Emergency Facility and other applicable sections.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fire Safety.</text> <paragraph num="(1)"> <text>The facility shall comply with the Maryland State Fire Prevention Code and applicable local fire prevention codes that are in effect at the time of plans review and construction.</text> </paragraph> <paragraph num="(2)"> <text>The local fire authority for the proposed facility shall review construction plans and conduct an initial inspection to verify compliance with fire safety requirements before use and occupancy.</text> </paragraph> <paragraph num="(3)"> <text>An annual fire inspection of the facility is required for license renewal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Housekeeping.</text> <paragraph num="(1)"> <text>The freestanding medical facility shall be clean and maintained in good repair at all times.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall employ sufficient staff to provide housekeeping and maintenance services, or the services may be provided under a contractual arrangement.</text> </paragraph> <paragraph num="(3)"> <text>The facility shall be maintained in a manner that is safe and free of pests or other hazards.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Equipment Maintenance.</text> <paragraph num="(1)"> <text>The freestanding medical facility shall have a preventive maintenance program for all facility systems and equipment.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall maintain records of preventive maintenance performed and of all service repairs.</text> </paragraph> <paragraph num="(3)"> <text>Appropriately trained staff employed by the facility or under contractual arrangements shall perform maintenance of clinical equipment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>All entrances, including ambulance entrances, shall be clearly marked and accessible at all times.</text> </paragraph> <paragraph num="F."> <text>There shall be a sheltered area for off-loading patients from ambulances.</text> </paragraph> <paragraph num="G."> <text>The facility shall store and dispose of trash and medical waste consistent with all federal and State laws and regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Emergency Preparedness."> <text>The freestanding medical facility shall develop an emergency preparedness plan to address internal and external emergencies. The emergency plan shall identify the manner by which the facility will interface with local emergency services and the affiliated hospital in the event of a major disaster.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="B."> <text>Notice of Emergency Suspension. The Department shall deliver a written notice to the licensee:</text> <paragraph num="(1)"> <text>Informing the licensee of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the licensee of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>Suspension of License. When a license is suspended by emergency action, the licensee shall:</text> <paragraph num="(1)"> <text>Immediately return the license to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Stop providing services immediately; and</text> </paragraph> <paragraph num="(3)"> <text>Notify patients or the patients' representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing consistent with Regulation .25 this chapter.</text> </paragraph> <paragraph num="F."> <text>Show Cause Hearing.</text> <paragraph num="(1)"> <text>In addition to the right to request a hearing consistent with Regulation .25 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be given the opportunity for a hearing to show cause why the Department should lift the summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Show Cause Hearing Procedures. The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who:</text> <paragraph num="(a)"> <text>Shall determine procedural issues;</text> </paragraph> <paragraph num="(b)"> <text>May impose reasonable time limits on each party's oral argument; and</text> </paragraph> <paragraph num="(c)"> <text>Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Results of a Show Cause Hearing. At the conclusion of the show cause hearing, the Secretary or the Secretary's designee may:</text> <paragraph num="(a)"> <text>Affirm the order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>After the show cause hearing, if the Secretary or the Secretary's designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .25 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Sanctions."> <paragraph num="A."> <text>In addition to other penalties available under State law, the Department may impose sanctions against a freestanding medical facility that fails to comply with Health-General Article, Subtitle 3A, Annotated Code of Maryland, or the regulations of this chapter. The sanctions include:</text> <paragraph num="(1)"> <text>A civil penalty not to exceed $10,000;</text> </paragraph> <paragraph num="(2)"> <text>Restrictions on the operation of the freestanding medical facility;</text> </paragraph> <paragraph num="(3)"> <text>A directed plan of correction; and</text> </paragraph> <paragraph num="(4)"> <text>Suspension or revocation of the freestanding medical facility's license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as otherwise provided under the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, before the Department may impose any sanctions under §A of this regulation, the Department shall provide the freestanding medical facility notice and an opportunity for a hearing and judicial review under the Administrative Procedure Act.</text> </paragraph> <paragraph num="C."> <text>Before the Department imposes a directed plan of correction, the Department shall give the freestanding medical facility notice and the opportunity for a prompt informal hearing with the Director of the Office of Health Care Quality.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Hearings."> <paragraph num="A."> <text>The licensee shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted consistent with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall issue a final decision consistent with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104 and Title 19, Subtitle 3A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 12, 2007 (34:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="09" heading="Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The provisions of this chapter apply to a health care facility which is licensed as a comprehensive or extended care facility under COMAR 10.07.02. These facilities are generally known as “nursing facilities”. Failure to comply with the regulations of this chapter is ground for licensure enforcement actions.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abuse of a Resident.</text> <paragraph num="(a)"> <text>“Abuse of a resident” means:</text> <paragraph num="(i)"> <text>The nontherapeutic infliction upon a resident of physical pain or injury, for example, striking a resident; or</text> </paragraph> <paragraph num="(ii)"> <text>A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Abuse of a resident” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another licensed health care professional practicing within the scope of the physician's or health care professional's license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Abuse of funds” means the misappropriation of a resident's assets or income. Misappropriation includes spending the resident's assets or income:</text> <paragraph num="(a)"> <text>Against or without the resident's consent, or, if the resident is incapable of giving consent and has no agent with authority to give consent, when the expenditure is not necessary for the direct and immediate benefit and welfare of the resident; or</text> </paragraph> <paragraph num="(b)"> <text>For the use and benefit of a person other than the resident, if the resident or agent has not consented to the expense.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant's or resident's share of costs or other charges for the facility's services.</text> </paragraph> <paragraph num="(4)"> <text>“Certified” means the designation attached to a nursing facility that has met the requirements for participation as a skilled nursing facility in the Medicare Program or as a nursing facility in the Medicaid Program.</text> </paragraph> <paragraph num="(4-1)"> <text>“Change in condition” means a significant change in the resident's physical, mental, or psychological status including, but not limited to:</text> <paragraph num="(a)"> <text>Life-threatening conditions such as heart attack or stroke;</text> </paragraph> <paragraph num="(b)"> <text>Clinical complications such as the:</text> <paragraph num="(i)"> <text>Development of a pressure sore;</text> </paragraph> <paragraph num="(ii)"> <text>Onset or recurrent periods of delirium;</text> </paragraph> <paragraph num="(iii)"> <text>Onset of recurrent urinary tract infection;</text> </paragraph> <paragraph num="(iv)"> <text>Onset of depression; and</text> </paragraph> <paragraph num="(v)"> <text>Onset of aggressive or inappropriate behavior;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The need to discontinue a medication or treatment because of:</text> <paragraph num="(i)"> <text>Adverse consequences; or</text> </paragraph> <paragraph num="(ii)"> <text>The need to begin a new form of treatment;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Evaluation at or admission to a hospital; or</text> </paragraph> <paragraph num="(e)"> <text>Accidents that result in injury having the potential for requiring a physician's intervention.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Chemical restraint” means use of a psychopharmacologic drug to control behavior and not otherwise required to treat medical symptoms.</text> </paragraph> <paragraph num="(6)"> <text>“Comprehensive care facility” means a nursing facility that admits residents suffering from disease or disabilities or advanced age, who require medical and nursing services rendered by or under the supervision of a registered nurse.</text> </paragraph> <paragraph num="(7)"> <text>“Consent” means an express agreement by a resident who is capable of making an informed decision or, in cases when the resident is not capable, by the resident's representative.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Director” means the Director of the Office on Aging.</text> </paragraph> <paragraph num="(10)"> <text>“Disabled resident” means a nursing facility resident who lacks sufficient understanding or capacity to make or communicate a responsible or informed decision on health care or personal finances because of a physical or mental disability, or because of substance abuse.</text> </paragraph> <paragraph num="(11)"> <text>“Discharge” means the:</text> <paragraph num="(a)"> <text>Removal of a resident from a nursing facility when the releasing nursing facility is no longer responsible for the resident's care;</text> </paragraph> <paragraph num="(b)"> <text>Movement of a resident from a certified bed to a noncertified bed;</text> </paragraph> <paragraph num="(c)"> <text>Movement of a resident from a skilled nursing facility bed under the Medicare Program to a bed not certified under that Program; or</text> </paragraph> <paragraph num="(d)"> <text>Movement of a resident from a bed certified only for Medicaid to a distinct part of the facility that is a skilled nursing facility under the Medicare Program.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Emergency” means a situation in which the life, health, or safety of an individual is in imminent and serious jeopardy.</text> </paragraph> <paragraph num="(13)"> <text>“Extended care facility” means a nursing facility that:</text> <paragraph num="(a)"> <text>Provides treatment services for residents requiring inpatient care but who do not currently require continuous hospital services; and</text> </paragraph> <paragraph num="(b)"> <text>Admits residents who:</text> <paragraph num="(i)"> <text>Require extensive restorative or rehabilitative services, or</text> </paragraph> <paragraph num="(ii)"> <text>Have a terminal disease requiring extensive nursing care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>Involuntary Transfer or Discharge.</text> <paragraph num="(a)"> <text>“Involuntary transfer or discharge” means a transfer or discharge of a resident that is initiated by a nursing facility without the consent of the resident or, when applicable, the resident's representative.</text> </paragraph> <paragraph num="(b)"> <text>“Involuntary discharge” includes a discharge as described in Regulation .12E of this chapter.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Licensee” means a person licensed by the Department to operate a comprehensive care facility or an extended care facility.</text> </paragraph> <paragraph num="(16)"> <text>“Licensing and Certification Administration” means the survey and licensing agency, a unit of the Department of Health.</text> </paragraph> <paragraph num="(17)"> <text>“Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.</text> </paragraph> <paragraph num="(18)"> <text>“Nursing facility” means a comprehensive care or extended care facility.</text> </paragraph> <paragraph num="(19)"> <text>“Office” means the Office on Aging.</text> </paragraph> <paragraph num="(20)"> <text>“Physical restraint” means a device, including material or equipment, attached or adjacent to a resident's body, that the resident cannot remove easily and that restricts the resident's freedom of movement.</text> </paragraph> <paragraph num="(21)"> <text>Private Pay.</text> <paragraph num="(a)"> <text>“Private pay” means a nursing facility's acceptance of payment from a source other than the Medical Assistance Program.</text> </paragraph> <paragraph num="(b)"> <text>“Private pay” includes reimbursement by the Medicare Program or other third-party insurer.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Relocation.</text> <paragraph num="(a)"> <text>“Relocation” means the movement of a resident from one room to another within:</text> <paragraph num="(i)"> <text>The same Medicare-certified facility;</text> </paragraph> <paragraph num="(ii)"> <text>A Medicaid-only certified nursing facility; or</text> </paragraph> <paragraph num="(iii)"> <text>A licensed-only nursing facility.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from:</text> <paragraph num="(i)"> <text>The distinct part of the nursing facility that is a skilled nursing facility to a distinct part of the nursing facility that is not a skilled nursing facility; or</text> </paragraph> <paragraph num="(ii)"> <text>A bed that is certified for Medicaid to a distinct part of the nursing facility that is a skilled nursing facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Representative” means a person referenced in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(24)"> <text>“Resident” means an individual who is admitted or remains in residence for overnight care in a nursing facility.</text> </paragraph> <paragraph num="(25)"> <text>“Resident funds” means the assets and income of a resident or nursing home applicant that are under the use, ownership, management, or control of the resident or resident's agent.</text> </paragraph> <paragraph num="(26)"> <text>“Residents' Bill of Rights” means the statement of basic rights of each resident of a nursing facility as set forth in:</text> <paragraph num="(a)"> <text>Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Title XIX of the Social Security Act, 42 U.S.C. §1396(5)(c);</text> </paragraph> <paragraph num="(c)"> <text>42 CFR §483.10 et seq.; and</text> </paragraph> <paragraph num="(d)"> <text>The regulations in this chapter.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Transfer” has the meaning as described in §B(11) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Resident's Representative."> <paragraph num="A."> <text>A nursing facility or nursing facility's agent shall recognize the authority of:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under the Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>A power of attorney established in compliance with Estates and Trusts Article, §13-601, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>An individual exercising a resident's rights pursuant to Health-General Article, §19-344(r), Annotated Code of Maryland, but not for purposes of medical care or treatment;</text> </paragraph> <paragraph num="(7)"> <text>A representative payee or other similar fiduciary;</text> </paragraph> <paragraph num="(8)"> <text>An agent as defined in Health-General Article, §19-344(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(9)"> <text>A person if that person was designated by a resident who was not disabled at the time the designation was made and if the resident or representative has provided the nursing facility with documentation of the designation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nursing facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority:</text> <paragraph num="(1)"> <text>Stated in the instrument that grants the representative authority; or</text> </paragraph> <paragraph num="(2)"> <text>Established by State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A facility shall document in the resident's record the name of a representative listed in this regulation, including a copy, when applicable, of the designation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Admission Procedures and Requirements."> <paragraph num="A."> <text>At the time of admission of a resident, and whenever information changes during the resident's stay, the nursing facility shall notify the resident and, when applicable, a representative or interested family member, in writing and orally, in a language that is easily understood of all terms of admission including, but not limited to the:</text> <paragraph num="(1)"> <text>Residents' Bill of Rights;</text> </paragraph> <paragraph num="(2)"> <text>Nursing facility's policies and procedures that implement the Residents' Bill of Rights;</text> </paragraph> <paragraph num="(3)"> <text>Rules of resident responsibility;</text> </paragraph> <paragraph num="(4)"> <text>Nursing facility's complaint procedure;</text> </paragraph> <paragraph num="(5)"> <text>Nursing facility's visitation rules;</text> </paragraph> <paragraph num="(6)"> <text>Procedures for obtaining a determination from the Medical Assistance Program of the amount of the resident's funds available to pay for the cost of the resident's care;</text> </paragraph> <paragraph num="(7)"> <text>Procedures for establishing eligibility for Medicaid and for receiving refunds for previous private payments covered by these benefits, including the right to request an assessment under 42 U.S.C. §1396r(5)(c) for the purpose of determining the:</text> <paragraph num="(a)"> <text>Extent of a couple's nonexempt resources at the time of institutionalization; and</text> </paragraph> <paragraph num="(b)"> <text>Amount of a couple's resources to be attributed to the community spouse as the spouse's equitable share of resources which are not considered available for payment toward the cost of the institutionalized spouse's medical care or for determining Medicaid eligibility for the institutionalized spouse; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Resident's rights under State law to formulate advance directives.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon admission of a resident, a nursing facility shall:</text> <paragraph num="(1)"> <text>Document in the resident's clinical record whether the resident has executed an advance directive and, if an advance directive exists, keep a copy of the advance directive in:</text> <paragraph num="(a)"> <text>The resident's clinical record; or</text> </paragraph> <paragraph num="(b)"> <text>A location within the nursing facility which is accessible to appropriate administrative, nursing, and medical personnel on a 24-hour a day basis;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prepare an inventory of all property that the resident is bringing into the nursing facility;</text> </paragraph> <paragraph num="(3)"> <text>Request the resident or representative to identify:</text> <paragraph num="(a)"> <text>Those items with a value of $100 or more;</text> </paragraph> <paragraph num="(b)"> <text>Any damage to an item existing before admission of the resident; and</text> </paragraph> <paragraph num="(c)"> <text>Whether the resident is retaining possession of each item or is entrusting the item to the nursing facility for safekeeping on behalf of the resident;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Give to the resident and, when applicable, the resident's representative or interested family member, a copy of the inventory prepared under §B(2) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Advise the resident and, when applicable, a representative or interested family member:</text> <paragraph num="(a)"> <text>Whether the nursing facility has purchased insurance to cover a resident's tangible personal property for loss or damage due to the facility's negligence; and</text> </paragraph> <paragraph num="(b)"> <text>Of the limits of insurance coverage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>With information provided by the resident or representative, a nursing facility shall periodically update the inventory of the resident's personal property with respect to items having a value of $100 or more.</text> </paragraph> <paragraph num="D."> <text>Required Notification. A nursing facility shall notify in writing:</text> <paragraph num="(1)"> <text>A resident who is entitled to Medicaid benefits at the time of admission, or when the resident becomes eligible for benefits, of:</text> <paragraph num="(a)"> <text>Items and services that are included in the per diem rate under Medicaid, and for which the resident may not be charged;</text> </paragraph> <paragraph num="(b)"> <text>Other items and services that the nursing facility offers and for which the resident may be charged, and the current range of charges for each item and service;</text> </paragraph> <paragraph num="(c)"> <text>The nursing facility's obligation following admission to notify the resident and, when applicable, the agent or interested family member, of any changes made to the items and services for which the resident may or may not be charged;</text> </paragraph> <paragraph num="(d)"> <text>The fact that the resident may not be required to pay for an item or service not covered by Medicaid unless the:</text> <paragraph num="(i)"> <text>Resident or, when applicable, the agent, knowingly requests the item or service; and</text> </paragraph> <paragraph num="(ii)"> <text>Resident receives the item or service; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The resident's right, within 90 days of receiving an item or service, to request an itemized statement of charges that:</text> <paragraph num="(i)"> <text>Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and</text> </paragraph> <paragraph num="(ii)"> <text>Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A private-pay resident, or the resident's agent, of:</text> <paragraph num="(a)"> <text>The items and services included in the nursing facility's basic per diem rate;</text> </paragraph> <paragraph num="(b)"> <text>The items and services that are covered by Medicare, and of the amount of any copayments or deductibles;</text> </paragraph> <paragraph num="(c)"> <text>Other services that the nursing facility offers and for which the resident may be charged, and the current range of charges for the services, including but not limited to charges related to a resident's monthly drug regimen review and other non-drug-related pharmacy costs;</text> </paragraph> <paragraph num="(d)"> <text>Whether the costs for supplies used in the performance of a service are included in the service charge and the costs of these supplies, within 24 hours of request, when the costs are not included in the service charge; and</text> </paragraph> <paragraph num="(e)"> <text>The resident's right, within 90 days of receiving an item or service or within 30 days of payment, to request an itemized statement of charges that:</text> <paragraph num="(i)"> <text>Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and</text> </paragraph> <paragraph num="(ii)"> <text>Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A resident of changes to be made to the items and services specified in §D(1) and (2) of this regulation, and increases in any fee or charge, or a new fee or charge, or a change in billing procedures, at least 45 days before the increase, new charge, or change becomes effective.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A nursing facility shall:</text> <paragraph num="(1)"> <text>Give the resident a copy of the statement of items, services, and charges provided by the facility;</text> </paragraph> <paragraph num="(2)"> <text>Provide information regarding services to be rendered by other health care providers, including:</text> <paragraph num="(a)"> <text>The cost to the resident;</text> </paragraph> <paragraph num="(b)"> <text>Transportation arrangements; and</text> </paragraph> <paragraph num="(c)"> <text>Direct or indirect financial interests that the nursing facility has in the provider.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Admission Prohibitions."> <paragraph num="A."> <text>The acts in §B of this regulation are admission prohibitions.</text> </paragraph> <paragraph num="B."> <text>A nursing facility may not:</text> <paragraph num="(1)"> <text>Require or solicit, as a condition of admission into the nursing facility, the signature of an individual other than the applicant on the application or contract for admission to the nursing facility, unless the:</text> <paragraph num="(a)"> <text>Applicant is adjudicated disabled in accordance with Estates and Trusts Article, §13-701, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Applicant's physician determines that the applicant is incapable of understanding or exercising the applicant's rights and responsibilities and records, in the applicant's nursing facility record, the specific reasons for the determination;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Require an individual, including an agent, to incur personal financial liability by signing the contract, although the nursing facility may require the individual to pay for nursing facility care for the resident to the extent of the resident's available income and assets;</text> </paragraph> <paragraph num="(3)"> <text>Charge, solicit, accept, or receive, in addition to any amount otherwise required to be paid under Medicaid, a gift, money, donation, or other consideration as a precondition of admission or expedited admission to, or continued stay in, the nursing facility;</text> </paragraph> <paragraph num="(4)"> <text>Require residents or applicants to waive their rights to Medicare or Medicaid;</text> </paragraph> <paragraph num="(5)"> <text>Require oral or written assurances that residents or applicants are not eligible for, or will not apply for, Medicare or Medicaid benefits;</text> </paragraph> <paragraph num="(6)"> <text>Charge individuals who are eligible for Medicaid more than the rates established by the Medical Assistance Program for these services;</text> </paragraph> <paragraph num="(7)"> <text>Increase any charge and make the resident liable for the increase until the 46th day after the facility notifies the resident in writing;</text> </paragraph> <paragraph num="(8)"> <text>Impose an interest penalty on charges for items and services provided to a resident until the later of the following:</text> <paragraph num="(a)"> <text>45 days after the nursing facility mails an itemized statement of charges to the resident or the resident's agent; or</text> </paragraph> <paragraph num="(b)"> <text>30 days after the end of the period covered by the itemized statement of charges;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Condition providing care or otherwise discriminate against a resident based on whether the resident has or has not executed an advance directive;</text> </paragraph> <paragraph num="(10)"> <text>Except for contributions toward cost of care as determined by the Medical Assistance Program, charge a resident who is eligible for Medicaid for services, unless the resident or the resident's agent knowingly has requested and received noncovered services, and the nursing facility:</text> <paragraph num="(a)"> <text>Has given proper notice of the availability and cost of the services to residents; and</text> </paragraph> <paragraph num="(b)"> <text>Does not condition the resident's admission or continued stay on the request for and receipt of additional services; and</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Solicit, accept, or receive a charitable, religious, or philanthropic contribution from an organization or an individual related to the resident or applicant unless the nursing facility makes clear that the contribution is not a condition of admission to, expedited admission to, or continued stay in the nursing facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Admission Contract Required."> <paragraph num="A."> <text>Before or upon admission, a nursing facility and applicant or, when applicable, the applicant's agent, shall execute an admission contract which has been approved by the Department.</text> </paragraph> <paragraph num="B."> <text>If the Department has approved a model contract, a nursing facility shall include within its contract, at a minimum, all of the provisions of the model contract.</text> </paragraph> <paragraph num="C."> <text>The nursing facility shall carefully explain all clauses of the contract and answer all questions that the applicant, the applicant's agent, and any interested family member may have.</text> </paragraph> <paragraph num="D."> <text>Except as required in §B of this regulation, the applicant and, when applicable, an agent, have the right to delete clauses or sections of the contract with which they do not agree, or to add clauses or sections, subject to the nursing facility's concurrence. Substantive changes require the Department's approval.</text> </paragraph> <paragraph num="E."> <text>An admission contract shall include a statement regarding the nursing facility's policies if private funds are exhausted during the resident's stay, including, in clear and concise language, any restrictions with respect to the acceptance of third-party payments.</text> </paragraph> <paragraph num="F."> <text>An admission contract used by a certified Medicaid provider shall clearly state that if private funds are exhausted during the resident's stay, and Medicaid payment is available, the nursing facility shall accept Medicaid payments on behalf of the resident.</text> </paragraph> <paragraph num="G."> <text>An admission contract used by a certified Medicaid provider shall inform the applicant, through a form established by the Department, that medical eligibility is a requirement for Medical Assistance, and that the applicant should learn if the applicant meets the Medicaid eligibility requirement at the time of admission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Third-Party Signature on Admission Contract."> <paragraph num="A."> <text>If a facility requires an individual, other than the applicant or resident, to sign the admission contract, the conditions of Regulation .05B(1) of this chapter shall be met.</text> </paragraph> <paragraph num="B."> <text>If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent accepts responsibility to pay for the cost of the resident's care only to the extent of the resident's available funds and assets.</text> </paragraph> <paragraph num="C."> <text>If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent is not, by signing the contract, accepting any responsibility for making payments from the agent's own personal funds, unless the agent does so voluntarily. The facility shall list separately in the contract any obligations voluntarily entered into by the agent, and the agent shall initial these obligations on the contract.</text> </paragraph> <paragraph num="D."> <text>An agent who has not paid a current obligation for the resident's care may apply to the Medical Assistance Program for a determination of the funds available to pay for the cost of the resident's care.</text> </paragraph> <paragraph num="E."> <text>An agent shall distribute any funds, including income or assets of the applicant or resident that the Medical Assistance Program has determined to be available, to pay for the cost of the resident's care in the facility.</text> </paragraph> <paragraph num="F."> <text>An agent shall seek, on behalf of the applicant or resident, all assistance from the Medical Assistance Program that may be available to the applicant or resident.</text> </paragraph> <paragraph num="G."> <text>The Attorney General may impose civil money penalties against an agent who wilfully or with gross negligence violates the requirements of this regulation as follows:</text> <paragraph num="(1)"> <text>An agent who wilfully or with gross negligence violates §E of this regulation is subject to a civil money penalty not less than the amount of funds subject to the violation; and</text> </paragraph> <paragraph num="(2)"> <text>An agent who wilfully or with gross negligence violates §F of this regulation is subject to a civil money penalty not exceeding $10,000.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Resident's Rights and Services."> <paragraph num="A."> <text>A nursing facility shall provide care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect, and in full recognition of the resident's individuality.</text> </paragraph> <paragraph num="B."> <text>A nursing facility may not interfere with a resident's exercise of rights guaranteed under the Constitution or laws of the United States and Maryland.</text> </paragraph> <paragraph num="C."> <text>A resident has the right to:</text> <paragraph num="(1)"> <text>Reside and receive services in a nursing facility with reasonable accommodations of individual needs and preferences, except when accommodations would endanger the health or safety of the resident or other residents;</text> </paragraph> <paragraph num="(2)"> <text>Receive treatment, care, and services that are in an environment that promotes maintenance or enhancement of each resident's quality of life;</text> </paragraph> <paragraph num="(3)"> <text>A dignified existence, self-determination, and communication with and access to individuals and services inside and outside the nursing facility;</text> </paragraph> <paragraph num="(4)"> <text>Be free of interference, coercion, discrimination, or reprisal from the nursing facility when exercising the resident's rights;</text> </paragraph> <paragraph num="(5)"> <text>Be free from:</text> <paragraph num="(a)"> <text>Physical abuse;</text> </paragraph> <paragraph num="(b)"> <text>Verbal abuse;</text> </paragraph> <paragraph num="(c)"> <text>Sexual abuse;</text> </paragraph> <paragraph num="(d)"> <text>Physical or chemical restraints imposed for purposes of discipline or convenience;</text> </paragraph> <paragraph num="(e)"> <text>Mental abuse; and</text> </paragraph> <paragraph num="(f)"> <text>Involuntary seclusion;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Choose an attending physician, if the physician agrees to abide by nursing facility policies and procedures, and the regulations in this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Choose a pharmacy to obtain medications as set forth in COMAR 10.07.02.15B(3) and D(3);</text> </paragraph> <paragraph num="(8)"> <text>Be fully informed in advance about care and treatment, and of proposed changes in that care or treatment;</text> </paragraph> <paragraph num="(9)"> <text>Participate in planning care and treatment, or changes in care or treatment;</text> </paragraph> <paragraph num="(10)"> <text>Seek advice from the resident care advisory committee concerning the options for medical care and treatment for an individual with a life-threatening condition in accordance with Health-General Article, §19-370 et seq., Annotated Code of Maryland;</text> </paragraph> <paragraph num="(11)"> <text>Consent to or refuse treatment, including the right to accept or reject artificially administered sustenance in accordance with State law;</text> </paragraph> <paragraph num="(12)"> <text>Self-administer drugs if the interdisciplinary team determines that the practice is safe;</text> </paragraph> <paragraph num="(13)"> <text>Access the resident's records within 24 hours, excluding weekends and holidays, upon an oral or written request;</text> </paragraph> <paragraph num="(14)"> <text>Purchase copies of all or part of the resident's records upon request by giving 2 working days advance notice to the nursing facility;</text> </paragraph> <paragraph num="(15)"> <text>Approve or refuse the release of personal and clinical records to an individual outside the nursing facility unless:</text> <paragraph num="(a)"> <text>Otherwise provided by Health-General Article, §4-301 et seq., Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>The release is required by law;</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Personal privacy, including:</text> <paragraph num="(a)"> <text>Confidentiality of personal records; and</text> </paragraph> <paragraph num="(b)"> <text>Privacy in:</text> <paragraph num="(i)"> <text>Medical treatment, and</text> </paragraph> <paragraph num="(ii)"> <text>Personal care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>Privacy in the resident's room, including the right to have nursing facility staff knock before entering the resident's room;</text> </paragraph> <paragraph num="(18)"> <text>Privacy in written communication, including the right to:</text> <paragraph num="(a)"> <text>Send and receive mail promptly without it being opened by anyone other than the resident, except when the resident requests assistance; and</text> </paragraph> <paragraph num="(b)"> <text>Have access to stationery, postage, and writing implements at the resident's own expense;</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Reasonable access to the private use of a telephone;</text> </paragraph> <paragraph num="(20)"> <text>Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions by the nursing facility on visiting hours and places;</text> </paragraph> <paragraph num="(21)"> <text>Visit or meet privately with the following, to whom the nursing facility shall provide reasonable access:</text> <paragraph num="(a)"> <text>A representative of the Secretary of the U.S. Department of Health and Human Services;</text> </paragraph> <paragraph num="(b)"> <text>A representative of the Department;</text> </paragraph> <paragraph num="(c)"> <text>The resident's personal physician;</text> </paragraph> <paragraph num="(d)"> <text>A representative of the State Long-Term Care Ombudsman Program;</text> </paragraph> <paragraph num="(e)"> <text>The agency responsible for advocacy and protection of developmentally disabled and mentally ill individuals in Maryland; or</text> </paragraph> <paragraph num="(f)"> <text>Any other legal representative;</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Visit privately with the resident’s spouse or domestic partner;</text> </paragraph> <paragraph num="(23)"> <text>Consent or deny consent to all visits, and may deny or withdraw consent at any time;</text> </paragraph> <paragraph num="(24)"> <text>Examine the results of the most recent federal and State surveys, including the annual survey and any subsequent complaint investigations, not otherwise prohibited by law, of the nursing facility and any plans of correction prompted by these surveys;</text> </paragraph> <paragraph num="(25)"> <text>Receive notice before the resident's roommate is changed and, to the extent possible, have input into the choice of roommate;</text> </paragraph> <paragraph num="(26)"> <text>Voice grievances, including those about treatment or care that is or fails to be furnished, and recommend changes in policies and services, to the staff or administrator of the nursing facility, the Licensing and Certification Administration, the Office on Aging, or any other person, without fear of reprisal, restraint, interference, coercion, or discrimination;</text> </paragraph> <paragraph num="(27)"> <text>Prompt efforts by the nursing facility to resolve grievances the resident may have, including those with respect to the behavior of other residents;</text> </paragraph> <paragraph num="(28)"> <text>Contact and receive information from agencies acting as client advocates;</text> </paragraph> <paragraph num="(29)"> <text>Refuse to perform services for the nursing facility;</text> </paragraph> <paragraph num="(30)"> <text>Perform services for the nursing facility if the resident chooses, only if:</text> <paragraph num="(a)"> <text>The nursing facility has documented the need or desire for work in the plan of care;</text> </paragraph> <paragraph num="(b)"> <text>The plan specifies the nature of the services to be performed and whether the services are voluntary or paid;</text> </paragraph> <paragraph num="(c)"> <text>Compensation for paid services is at or above prevailing rates; and</text> </paragraph> <paragraph num="(d)"> <text>The resident agrees in writing to the work arrangement described in the plan of care, and the contract is part of the resident's record;</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>Share a room with the resident's spouse if both spouses consent and it is not medically contraindicated; and</text> </paragraph> <paragraph num="(32)"> <text>Participate in social, religious, and community activities if the activities do not interfere with the rights of other residents in the nursing facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A resident has the right to participate or refuse to participate in experimental research. When the resident is incapable of making this decision, the resident's appropriate representative may consent for participation in therapeutic experimental research only.</text> </paragraph> <paragraph num="E."> <text>The resident or, when applicable, the resident's health care representative, has the right to be fully informed, in a language that the resident or representative can reasonably be expected to understand, of complete and current information about the resident's diagnosis, treatment, and prognosis, unless it would be medically inadvisable as documented by the resident's attending health care provider. If this determination has been made, the health care provider shall, upon written request:</text> <paragraph num="(1)"> <text>Make a summary of the undisclosed portion of the medical record available to the resident or health care representative;</text> </paragraph> <paragraph num="(2)"> <text>Insert a copy of the summary in the medical record of the resident;</text> </paragraph> <paragraph num="(3)"> <text>Permit examination and copying of the medical record by another health care provider; and</text> </paragraph> <paragraph num="(4)"> <text>Inform the resident or health care representative of the resident's or health care representative's right to select another health care provider.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Resident and Family Groups.</text> <paragraph num="(1)"> <text>A resident has the right to organize and participate in resident groups in the nursing facility.</text> </paragraph> <paragraph num="(2)"> <text>A resident's family has the right to meet in the nursing facility with the families of other residents.</text> </paragraph> <paragraph num="(3)"> <text>Staff or other visitors may attend meetings only at the group's invitation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Implementation of Residents' Bill of Rights."> <text>A nursing facility shall:</text> <paragraph num="A."> <text>Ensure that:</text> <paragraph num="(1)"> <text>The rights of residents as set forth in the Residents' Bill of Rights are protected, including but not limited to informing each resident of the resident's right to select a physician and pharmacy of the resident's choice;</text> </paragraph> <paragraph num="(2)"> <text>Employees of the nursing facility are trained to:</text> <paragraph num="(a)"> <text>Respect and enforce the Residents' Bill of Rights and the nursing facility's policies and procedures that implement the Residents' Bill of Rights; and</text> </paragraph> <paragraph num="(b)"> <text>Protect the rights of residents;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The nursing facility's policies and procedures implement all rights of the residents as set forth in:</text> <paragraph num="(a)"> <text>Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Title XIX of the Social Security Act;</text> </paragraph> <paragraph num="(c)"> <text>42 CFR §483.10 et seq.; and</text> </paragraph> <paragraph num="(d)"> <text>The regulations of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The nursing facility's policies comply with the requirements of federal and State law concerning advance directives, including but not limited to:</text> <paragraph num="(a)"> <text>If an applicant is incapacitated or is incapable of informing the nursing facility whether the applicant has executed an advance directive, the facility may provide advance directive information to the resident's health care representative; and</text> </paragraph> <paragraph num="(b)"> <text>Once the resident is no longer incapacitated, the facility shall provide the advance directive information to the resident directly at the appropriate time;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Post conspicuously in a public place accessible to residents:</text> <paragraph num="(1)"> <text>The Residents' Bill of Rights in large, clearly readable type;</text> </paragraph> <paragraph num="(2)"> <text>The nursing facility's complaint procedures in large, clearly readable type;</text> </paragraph> <paragraph num="(3)"> <text>The nursing facility's statement of deficiencies for the most recent survey and any subsequent complaint investigations conducted by federal or State surveyors and any plans of correction in effect with respect to the survey or complaint investigation findings; and</text> </paragraph> <paragraph num="(4)"> <text>Signs provided by the Department to notify the visiting public and residents:</text> <paragraph num="(a)"> <text>That complaints may be made to the Department or to the Office;</text> </paragraph> <paragraph num="(b)"> <text>How to report an instance of abuse of a resident to the Department, the Office, or law enforcement agencies; and</text> </paragraph> <paragraph num="(c)"> <text>How to file a complaint with State agencies and client advocacy agencies, such as the Licensing and Certification Administration, the Office on Aging, the Older Americans Act Legal Services providers, the Maryland Disabilities Law Center, State Medicaid Fraud Unit, and the Legal Aid Bureau, Inc.;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Establish and maintain identical policies and practices regarding transfer, discharge, and the provision of services under the State plan for all individuals, regardless of source of payment;</text> </paragraph> <paragraph num="D."> <text>Provide each resident and, if applicable, the resident's appropriate representative or interested family member, with a written description of the resident's legal rights, including a:</text> <paragraph num="(1)"> <text>Description of the manner of protecting resident funds; and</text> </paragraph> <paragraph num="(2)"> <text>Statement that the resident may file a complaint with the Department or the Office concerning resident abuse, neglect, misappropriation of resident property in the nursing facility, and noncompliance with advance directive requirements;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Place the name, address, and telephone number of the physician who is responsible for the resident's care within easy access of the resident;</text> </paragraph> <paragraph num="F."> <text>Inform the resident and the appropriate legal representative, or interested family member, and promptly consult with the resident's physician if any of the following incidents occur:</text> <paragraph num="(1)"> <text>An accident involving the resident which results in injury;</text> </paragraph> <paragraph num="(2)"> <text>A significant change in the resident's physical, mental, or psychosocial status;</text> </paragraph> <paragraph num="(3)"> <text>A need to alter treatment significantly; or</text> </paragraph> <paragraph num="(4)"> <text>A decision to transfer or discharge the resident from the nursing facility;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Consistent with State and federal confidentiality laws and, in a timely manner, notify a resident and, if applicable, the resident's representative or interested family member, of any:</text> <paragraph num="(1)"> <text>Change in condition;</text> </paragraph> <paragraph num="(2)"> <text>Adverse event that may result in a change in condition;</text> </paragraph> <paragraph num="(3)"> <text>Outcome of care that results in an unanticipated consequence; and</text> </paragraph> <paragraph num="(4)"> <text>Corrective action, if any;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Notify the resident and, when applicable, the appropriate representative, or interested family member, when there is a change in:</text> <paragraph num="(1)"> <text>Room or roommate assignment;</text> </paragraph> <paragraph num="(2)"> <text>The Residents' Bill of Rights; or</text> </paragraph> <paragraph num="(3)"> <text>Federal or State law and regulations relating to residents' rights;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Record and update the address and phone number of the resident's representatives and interested family members;</text> </paragraph> <paragraph num="J."> <text>Permit representatives of the State Long-Term Care Ombudsman Program to accomplish their responsibilities, as set forth in 42 U.S.C. §3058g, the State Long-Term Care Ombudsman Program;</text> </paragraph> <paragraph num="K."> <text>Encourage the activities of resident and family groups by:</text> <paragraph num="(1)"> <text>Providing the residents and their families with private space for meetings;</text> </paragraph> <paragraph num="(2)"> <text>Designating a staff person to provide assistance and respond to written requests from residents and their families;</text> </paragraph> <paragraph num="(3)"> <text>Listening to the views of residents and their families;</text> </paragraph> <paragraph num="(4)"> <text>Acting upon the grievances and recommendations of residents and their families concerning proposed policy and operational decisions affecting resident care and life in the nursing facility; and</text> </paragraph> <paragraph num="(5)"> <text>Advising resident and family groups of the disposition of their grievances and recommendations;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Educate staff, residents, representatives, and interested family members on advance directives;</text> </paragraph> <paragraph num="M."> <text>When applicable, promptly provide the Medical Assistance Program with all required information in its possession; and</text> </paragraph> <paragraph num="N."> <text>Provide copies of clinical records upon request, based on the following charges:</text> <paragraph num="(1)"> <text>A fee for copying and mailing not exceeding 50 cents per page;</text> </paragraph> <paragraph num="(2)"> <text>A discretionary fee not to exceed $15 for record retrieval and preparation;</text> </paragraph> <paragraph num="(3)"> <text>The actual cost of postage and handling of the copies; and</text> </paragraph> <paragraph num="(4)"> <text>A discretionary annual adjustment in the fees described in §M(1)—(3) of this regulation based on the current Consumer Price Index.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Resident Transfers and Discharges."> <paragraph num="A."> <text>A nursing facility may not involuntarily transfer or discharge a resident from the nursing facility unless the:</text> <paragraph num="(1)"> <text>Transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>Transfer or discharge is appropriate because the resident's health has improved sufficiently so that the resident no longer needs the health care or services provided by the nursing facility;</text> </paragraph> <paragraph num="(3)"> <text>Resident's presence endangers the health or safety of other individuals in the nursing facility;</text> </paragraph> <paragraph num="(4)"> <text>Resident has failed, after reasonable and appropriate notice, to pay, or to have paid under third-party payers, for a stay at the nursing facility; or</text> </paragraph> <paragraph num="(5)"> <text>Nursing facility ceases to operate or, in the case of a resident who receives Medicare or Medicaid services, when the nursing facility has been decertified or has withdrawn from the Medicare or Medicaid Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A resident has a right to request a hearing on the proposed transfer or discharge, except when the transfer or discharge is being taken pursuant to §A(5) of this regulation.</text> </paragraph> <paragraph num="C."> <text>Notice.</text> <paragraph num="(1)"> <text>Transfer and Discharge. Except in emergency situations such as a hospitalization, or if the resident has not resided in the facility for 30 days, the nursing facility shall notify the resident, representative, or interested family member, the State Long-Term Care Ombudsman, and the Department at least:</text> <paragraph num="(a)"> <text>30 days before any proposed transfer or discharge if the nursing facility is not part of a continuing care retirement community as defined in Article 70B, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>60 days before any proposed transfer or discharge if the nursing facility is part of a continuing care retirement community.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Emergency Transfers, Discharges, and Relocations. In an emergency situation, a nursing facility shall notify the resident, representative, or interested family member of a transfer as soon as possible.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Contents of Notice. The required notice to a resident under this regulation shall be on a form developed by the Department and shall include:</text> <paragraph num="(1)"> <text>Each reason for the proposed transfer or discharge;</text> </paragraph> <paragraph num="(2)"> <text>A statement that the resident has the right to request a hearing on a proposed transfer or discharge, and how to request a hearing pursuant to Regulation .13 of this chapter, except in the case of a discharge made pursuant to §A(5) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>The name, address, and telephone number of the State's Office on Aging and local office on aging long-term care ombudsman;</text> </paragraph> <paragraph num="(4)"> <text>The right of a resident to consult with any lawyer the resident chooses;</text> </paragraph> <paragraph num="(5)"> <text>The name, address, and telephone number of the Legal Aid Bureau, The Older American Act Senior Legal Assistance Programs, and other agencies that may provide assistance to individuals who need legal counsel;</text> </paragraph> <paragraph num="(6)"> <text>For nursing facility residents with developmental disabilities, the mailing address and telephone number of the agency responsible for the protection and advocacy of developmentally disabled individuals;</text> </paragraph> <paragraph num="(7)"> <text>For nursing facility residents who are mentally ill, the mailing address and telephone number of the agency responsible for the protection and advocacy of mentally ill individuals;</text> </paragraph> <paragraph num="(8)"> <text>The effective date of the proposed transfer or discharge which, except as set forth in §C of this regulation, is at least 30 days after receiving the notice and at least 60 days after receipt of the notice if the nursing facility is part of a continuing care retirement center; and</text> </paragraph> <paragraph num="(9)"> <text>The resident's rights concerning discharge, as set forth in Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation.</text> <paragraph num="(1)"> <text>In the event of a discharge or transfer of a resident, a nursing facility shall ensure that the following appears in the resident record:</text> <paragraph num="(a)"> <text>The circumstances surrounding the discharge or transfer, including interventions initiated by the facility before proposing the discharge;</text> </paragraph> <paragraph num="(b)"> <text>The notice described in §§C and D of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>If applicable, any express consent given by the resident or, when applicable, the resident's representative.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a resident is transferred or discharged pursuant to §A(1) and (2) of this regulation, the resident's physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary.</text> </paragraph> <paragraph num="(3)"> <text>When a resident is transferred or discharged pursuant to §A(3) of this regulation, a physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Involuntary Discharge or Transfer of a Resident."> <paragraph num="A."> <text>In addition to the provisions of Regulation .10 of this chapter, a facility may not involuntarily discharge or transfer a resident unless, within 48 hours before the discharge or transfer, the facility has:</text> <paragraph num="(1)"> <text>Provided or obtained:</text> <paragraph num="(a)"> <text>A comprehensive medical assessment and evaluation of the resident, including a physical examination, that is documented in the resident's medical record;</text> </paragraph> <paragraph num="(b)"> <text>A post-discharge plan of care for the resident that is developed, if possible, with the participation of the resident's representative; and</text> </paragraph> <paragraph num="(c)"> <text>Written documentation from the resident's attending physician indicating that the transfer or discharge is in accordance with the post-discharge plan of care and is not contraindicated by the resident's medical condition; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provided information to the resident concerning the resident's rights to make decisions concerning health care, including the right to:</text> <paragraph num="(a)"> <text>Accept or refuse medical treatment;</text> </paragraph> <paragraph num="(b)"> <text>Make an advance directive, including the right to make a living will and the right to appoint an agent to make health care decisions; and</text> </paragraph> <paragraph num="(c)"> <text>Revoke an advance directive.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>With the exception of residents of a certified continuing care facility as set forth in §D of this regulation, at the time of transfer or discharge, the facility shall provide the resident and, when appropriate, the representative or interested family member with:</text> <paragraph num="(1)"> <text>A written statement of the medical assessment and evaluation and post-discharge plan of care required under §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>A written statement itemizing the medications currently being taken by the resident;</text> </paragraph> <paragraph num="(3)"> <text>To the extent permitted under federal and State law, at least a 3-day supply of the medications currently being taken by the resident;</text> </paragraph> <paragraph num="(4)"> <text>Information necessary to assist the resident or the resident's representative in obtaining additional prescriptions for necessary medication through consultation with the resident's attending physician; and</text> </paragraph> <paragraph num="(5)"> <text>A written statement containing the date, time, method, mode, and destination of the resident's discharge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A facility may not discharge or transfer a resident:</text> <paragraph num="(1)"> <text>Unless the resident or appropriate representative consented in writing to the discharge or transfer; or</text> </paragraph> <paragraph num="(2)"> <text>Except when the discharge or transfer:</text> <paragraph num="(a)"> <text>Is in accordance with a post-discharge plan of care developed under §A of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Is to a safe and secure environment where the resident will be under the care of a:</text> <paragraph num="(i)"> <text>Licensed, certified, or registered care provider; or</text> </paragraph> <paragraph num="(ii)"> <text>Person who has agreed in writing to provide a safe and secure environment.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A continuing care facility certified under Article 70B, Annotated Code of Maryland, is not subject to §B of this regulation if the:</text> <paragraph num="(1)"> <text>Facility transfers a resident to a lesser level of care within the same facility in accordance with a contract between the facility and the resident; and</text> </paragraph> <paragraph num="(2)"> <text>Transfer is approved by the resident's attending physician.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the requirements of §§A—D of this regulation have been met, the resident's representative, in conjunction with the facility, shall cooperate and assist in the resident's discharge planning, including:</text> <paragraph num="(1)"> <text>Contacting, cooperating with, and assisting other health care facilities considering admitting the resident; and</text> </paragraph> <paragraph num="(2)"> <text>Cooperating with government agencies, including applying for Medical Assistance for the resident.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If requested by a person during the process of transferring or discharging a resident, or on its own initiative, the Office of the Attorney General may investigate whether an abuse of a resident's funds contributed to the decision to transfer or discharge the resident, and may make appropriate referrals of the matter to other government agencies.</text> </paragraph> <paragraph num="G."> <text>The Secretary may impose a civil money penalty not to exceed $10,000 for each:</text> <paragraph num="(1)"> <text>Violation by a facility of its obligations under this regulation and Regulation .10 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Willfully or grossly negligent violation by a resident's representative of the representative's obligations under this regulation and Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If a civil money penalty is imposed under §G of this regulation, the facility or representative has the right to request a hearing on the proposed civil money penalty in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.04.</text> </paragraph> <paragraph num="I."> <text>A resident, resident's representative, resident's attorney, or the Attorney General, on behalf of a resident who believes that an involuntary discharge or transfer that violates this regulation is imminent or has taken place, may request appropriate injunctive relief from the appropriate circuit court.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Resident Relocation and Bed Hold."> <paragraph num="A."> <text>Notification of Resident Relocation Within a Facility.</text> <paragraph num="(1)"> <text>Except in emergency situations or when it is documented in the resident's record that a resident's physical, clinical, or psychological well-being would be jeopardized, a nursing facility shall notify a resident or, when applicable, the resident's representative or interested family member, if available, in writing at least 30 days before the resident is relocated within a facility or to a different part of a facility, unless the resident or, if the resident is incapacitated, the resident's legally authorized representative, agrees to the relocation and this is documented in the resident's record.</text> </paragraph> <paragraph num="(2)"> <text>Under the limited conditions set forth in §A(1) of this regulation where 30-days notice cannot be provided in advance of a relocation, the facility shall document that it has provided notice of the relocation as soon as practicable.</text> </paragraph> <paragraph num="(3)"> <text>When a resident is relocated, the facility shall elicit and make reasonable efforts to comply with the resident's request of location and, if applicable, assignment of roommate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A resident's right to refuse a change in room assignment under §A of this regulation does not affect the resident's eligibility or entitlement to Medicaid benefits.</text> </paragraph> <paragraph num="C."> <text>Notice.</text> <paragraph num="(1)"> <text>Notice of Bed-Hold Policy at the Time of Admission. At the time of admission, a nursing facility shall provide written information to a resident or, when applicable, the resident's representative or interested family member, describing the facility's bed-hold policy, including the period of time during which the resident is permitted to return and resume residence in the nursing facility.</text> </paragraph> <paragraph num="(2)"> <text>Notice of Bed-Hold Policy at Time of Transfer. At the time of transfer of a resident to a hospital or for therapeutic leave, a nursing facility shall provide a written notice to the resident, or when applicable, the resident's representative or interested family member, which specifies the duration of the bed-hold policy described in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Permitting a Resident to Return to the Nursing Facility. When a resident's hospitalization or therapeutic leave exceeds the bed-hold period under the State Medicaid plan, the resident has a right to be readmitted to the nursing facility immediately upon the first availability of a bed in a semiprivate room if the resident:</text> <paragraph num="(1)"> <text>Requires the services provided by the nursing facility; and</text> </paragraph> <paragraph num="(2)"> <text>Is eligible for Medicaid coverage for the nursing facility's services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Unless the bed hold has expired, for purposes of this regulation, transfer includes the refusal of a nursing facility to accept the return of a resident who was previously transferred from the nursing facility:</text> <paragraph num="(1)"> <text>Whose bed at the nursing facility was continuously reserved or required to be reserved through payment to the nursing facility from any source; or</text> </paragraph> <paragraph num="(2)"> <text>Who had an application for medical assistance pending at the time of the transfer if there is no reason to believe that the application will not be approved.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Transfer and Discharge Planning. In addition to the requirements of Regulation .11 of this chapter, a nursing facility shall provide, in all cases, orientation and planning to residents to ensure safe and orderly transfer of discharge from the nursing facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Hearings for Transfers and Discharges, and Establishment of an Escrow Account."> <paragraph num="A."> <text>A resident may request a hearing within 30 days of receiving a notice of an intended involuntary transfer or discharge as provided in Regulation .10C of this chapter.</text> </paragraph> <paragraph num="B."> <text>Except in an emergency or when the resident has resided in a facility for less than 30 days, after a request for a hearing has been filed, a nursing facility may not discharge or transfer the resident until:</text> <paragraph num="(1)"> <text>A final decision is issued after the hearing and all requirements of Regulation .11 of this chapter are met; or</text> </paragraph> <paragraph num="(2)"> <text>The resident consents to the discharge or transfer and withdraws the request for a hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedure.</text> <paragraph num="(1)"> <text>The resident shall send a written request for a hearing to the Office of Administrative Hearings by the 30th calendar day after the resident receives the nursing facility's notice of the proposed transfer or discharge.</text> </paragraph> <paragraph num="(2)"> <text>After receiving the written request, the Office of Administrative Hearings shall schedule a hearing.</text> </paragraph> <paragraph num="(3)"> <text>The Office of Administrative Hearings shall conduct the hearing in accordance with COMAR 10.01.04 and 28.02.01.</text> </paragraph> <paragraph num="(4)"> <text>The Department is not a party to a hearing conducted pursuant to this regulation. The parties are the nursing facility and the resident. Therefore, a hearing conducted pursuant to this regulation is not a contested case as defined in the Administrative Procedure Act, State Government Article, §10-202, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A facility may require that an escrow account be established when the:</text> <paragraph num="(1)"> <text>Basis for a resident's discharge is nonpayment; and</text> </paragraph> <paragraph num="(2)"> <text>Resident continues to reside in the facility pending a final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If an escrow account is required under §D of this regulation, the facility shall develop a policy and procedure that is acceptable to the Department concerning the establishment and disposition of funds from the escrow account.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Physical and Chemical Restraints."> <paragraph num="A."> <text>Physical restraints may be used only:</text> <paragraph num="(1)"> <text>As an integral part of an individual medical treatment plan;</text> </paragraph> <paragraph num="(2)"> <text>If absolutely necessary to protect the resident or others from injury;</text> </paragraph> <paragraph num="(3)"> <text>If prescribed by a physician or administered by another health care professional practicing within the scope of their license; and</text> </paragraph> <paragraph num="(4)"> <text>If less restrictive alternatives were considered and appropriately ruled out by the physician.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Use of Physical Restraints.</text> <paragraph num="(1)"> <text>When a facility uses physical restraints, personnel:</text> <paragraph num="(a)"> <text>Trained in the use of restraints shall check a resident in restraint at least every 2 hours, and maintain a record of the checks and usage; and</text> </paragraph> <paragraph num="(b)"> <text>Shall provide opportunities for motion and exercise during each 2-hour period in which physical restraint is used, and shall monitor the use of the restraint use and maintain a record of it.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The attending physician shall ensure that treatment plans include provisions for the progressive elimination of physical restraints.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Use of Psychopharmacologic Drugs. When a physician prescribes psychopharmacologic drugs for a resident, the resident's clinical records shall contain all of the following documentation:</text> <paragraph num="(1)"> <text>A physician's indication that the dosage, duration, indication, and monitoring are clinically appropriate and the reasons why they are clinically appropriate;</text> </paragraph> <paragraph num="(2)"> <text>Indication that the resident is being monitored for adverse complications of the drug therapy;</text> </paragraph> <paragraph num="(3)"> <text>Confirmation that previous attempts at dosage reduction have been unsuccessful, if applicable;</text> </paragraph> <paragraph num="(4)"> <text>Evidence of the resident's subjective or objective improvement, or maintenance or function, while taking the medication;</text> </paragraph> <paragraph num="(5)"> <text>Evidence that the resident's decline or deterioration, if applicable, has been evaluated by the interdisciplinary team to determine whether a particular drug, a particular dosage, or duration of therapy may be the cause;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of why the resident's age, weight, or other factors would require a unique drug dose, drug duration, indication, or monitoring; or</text> </paragraph> <paragraph num="(7)"> <text>Other evidence that substantiates the use of the restraint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Abuse of Residents."> <paragraph num="A."> <text>A nursing facility shall develop and implement policies and procedures prohibiting abuse and neglect of residents.</text> </paragraph> <paragraph num="B."> <text>A nursing facility may not knowingly employ an individual who has been convicted of abusing or neglecting a resident or who has had a finding entered into the State Nurse Aide Registry concerning abuse or neglect of a resident or misappropriation of a resident's property.</text> </paragraph> <paragraph num="C."> <text>Reports of Abuse.</text> <paragraph num="(1)"> <text>A person who believes that a resident has been abused shall promptly report the alleged abuse to the:</text> <paragraph num="(a)"> <text>Appropriate law enforcement agency;</text> </paragraph> <paragraph num="(b)"> <text>Licensing and Certification Administration within the Department; or</text> </paragraph> <paragraph num="(c)"> <text>The Office on Aging.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An employee of a nursing facility who believes that a resident has been abused:</text> <paragraph num="(a)"> <text>Shall report the alleged abuse as set forth in §C(1) of this regulation within 3 days after learning of the alleged abuse;</text> </paragraph> <paragraph num="(b)"> <text>May be subject to a penalty imposed by the Secretary of up to $1,000 for failing to report an alleged abuse within 3 days after learning of the alleged abuse.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual on whom a penalty has been imposed may request a hearing on the penalty by submitting a written request for a hearing to the Department on or before the 30th calendar day after the individual received notice of the imposition of the penalty.</text> </paragraph> <paragraph num="(4)"> <text>Upon receiving a request for a hearing under this section, the Secretary shall conduct a hearing in accordance with COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Investigations. A nursing facility shall:</text> <paragraph num="(1)"> <text>Thoroughly investigate all allegations of abuse; and</text> </paragraph> <paragraph num="(2)"> <text>Take appropriate action to prevent further incidents of abuse while the investigation is in progress, and after that.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability described in Health-General Article, §19-347(g), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Complaint Procedure."> <paragraph num="A."> <text>A resident, the resident's representative, or an interested individual has the right to:</text> <paragraph num="(1)"> <text>Make a complaint about the nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>Recommend a change in facility policy and procedure; and</text> </paragraph> <paragraph num="(3)"> <text>Be free from reprisal, restraint, interference, coercion, or discrimination by the nursing facility or its employees as a result of making a complaint or recommending a change in policy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nursing facility shall develop and implement the following complaint procedures:</text> <paragraph num="(1)"> <text>A resident, the resident's representative, or an interested individual may present complaints to:</text> <paragraph num="(a)"> <text>The nursing facility administration;</text> </paragraph> <paragraph num="(b)"> <text>The nursing facility's staff;</text> </paragraph> <paragraph num="(c)"> <text>The Office;</text> </paragraph> <paragraph num="(d)"> <text>The Department; or</text> </paragraph> <paragraph num="(e)"> <text>Other persons or groups;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A complaint may be made to the nursing facility in person, orally or in writing, by telephone or by mail, and may be reported anonymously;</text> </paragraph> <paragraph num="(3)"> <text>A nursing facility may not require the signature of the resident or, when applicable, the resident's representative or an interested individual on a complaint;</text> </paragraph> <paragraph num="(4)"> <text>If a complaint is presented to a nursing facility, the nursing facility shall investigate within 30 days the allegations made in the complaint and advise the complainant of the action the nursing facility is taking to resolve the complaint;</text> </paragraph> <paragraph num="(5)"> <text>A nursing facility shall send to the Office and the Department a copy of any complaint that a complainant indicates has not been resolved to the satisfaction of the complainant;</text> </paragraph> <paragraph num="(6)"> <text>A nursing facility shall maintain a permanent record for inspection by the Office or the Department of all complaints concerning the nursing facility; and</text> </paragraph> <paragraph num="(7)"> <text>A complainant may request a hearing from the Department within 30 days of receiving the facility's response to the complaint or within 60 days of filing the complaint, whichever is earlier.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A complaint which has not been resolved to the satisfaction of the complainant may be resolved through a hearing as follows:</text> <paragraph num="(1)"> <text>After receiving a written request for a hearing, the Department shall forward a copy of the request to the Office and schedule a hearing;</text> </paragraph> <paragraph num="(2)"> <text>The nursing facility may be represented by the nursing facility administrator, designee, or counsel;</text> </paragraph> <paragraph num="(3)"> <text>The complainant may be represented by:</text> <paragraph num="(a)"> <text>The complainant;</text> </paragraph> <paragraph num="(b)"> <text>The Office;</text> </paragraph> <paragraph num="(c)"> <text>Counsel; or</text> </paragraph> <paragraph num="(d)"> <text>Any other individual;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department's Director of Licensing and Certification, or a designee of the Director, shall conduct the hearing;</text> </paragraph> <paragraph num="(5)"> <text>The Director or the Director's designee may:</text> <paragraph num="(a)"> <text>Receive testimony from both parties;</text> </paragraph> <paragraph num="(b)"> <text>If appropriate, issue deficiencies and require the nursing facility to submit a plan of correction;</text> </paragraph> <paragraph num="(c)"> <text>Attempt to assist the parties in reaching a satisfactory resolution;</text> </paragraph> <paragraph num="(d)"> <text>Notify the complainant of the results of the findings and any actions taken; and</text> </paragraph> <paragraph num="(e)"> <text>Notify the appropriate State's attorney if there is evidence of criminal conduct.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A hearing conducted under §C of this regulation is not a contested case as defined in State Government Article, §10-202, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Personal Property of Residents."> <paragraph num="A."> <text>Personal Possessions.</text> <paragraph num="(1)"> <text>A resident has the right to retain and use personal possessions, including furnishings and appropriate clothing as space permits, unless to do so would be detrimental to the rights or health and safety of other residents.</text> </paragraph> <paragraph num="(2)"> <text>A facility shall take reasonable steps to ensure the safety and security of the personal belongings of its residents.</text> </paragraph> <paragraph num="(3)"> <text>A facility shall provide a reasonable amount of locked storage space for personal property upon the request of a resident.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nursing facility may not limit the amount of funds it keeps on behalf of a resident, but may limit the amount of other property that it retains on behalf of the resident.</text> </paragraph> <paragraph num="C."> <text>A nursing facility shall establish written procedures to prevent loss or damage to, and protect, property.</text> </paragraph> <paragraph num="D."> <text>A nursing facility shall establish written procedures for investigating an incident of loss or damage to the property of a resident, including:</text> <paragraph num="(1)"> <text>A procedure by which an individual, including a resident or representative of a resident, may report loss or damage;</text> </paragraph> <paragraph num="(2)"> <text>The designation of an employee of the nursing facility to:</text> <paragraph num="(a)"> <text>Receive reports of loss or damage;</text> </paragraph> <paragraph num="(b)"> <text>Conduct an investigation; and</text> </paragraph> <paragraph num="(c)"> <text>Inform the resident, or when applicable, a representative or interested family member, of the results of the investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Release of Personal Property. A nursing facility shall release the property of a resident to:</text> <paragraph num="(1)"> <text>The resident or a representative upon the:</text> <paragraph num="(a)"> <text>Request of the resident; or</text> </paragraph> <paragraph num="(b)"> <text>Transfer or discharge of the resident from the nursing facility; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A government agency acting pursuant to legal authority.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition of Personal Property Upon the Death of a Resident.</text> <paragraph num="(1)"> <text>Immediately upon but not later than 30 business days after the death of a resident, a nursing facility shall provide notice of the resident's property being held by the facility to:</text> <paragraph num="(a)"> <text>The resident's representative or interested family member; and</text> </paragraph> <paragraph num="(b)"> <text>Government agencies which have paid any part of the nursing facility charges for the resident.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the death of a resident, the nursing facility shall release:</text> <paragraph num="(a)"> <text>The resident's wearing apparel other than furs and jewels to a representative or immediate family member; and</text> </paragraph> <paragraph num="(b)"> <text>Other personal property only to an individual who presents certified letters of administration that designate the individual as “Representative of the Estate of _______________________________________________”.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Personal property or income derived from the cash conversion of personal property that a facility holds for a discharged or deceased resident is presumed abandoned in accordance with Commercial Law Article, Title 17, Annotated Code of Maryland, when the property or income from cash conversion is not claimed within 1 year.</text> </paragraph> <paragraph num="(4)"> <text>When a nursing facility is still holding a resident's personal property 1 year after the resident's death, the nursing facility shall notify the Unclaimed Property Section, Comptroller of the Treasury, for appropriate direction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Protection of a Resident's Personal Funds."> <paragraph num="A."> <text>A resident has the right to:</text> <paragraph num="(1)"> <text>Manage the resident's financial affairs; or</text> </paragraph> <paragraph num="(2)"> <text>Choose any person who is willing to handle the resident's financial affairs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as authorized by being appointed representative payee, a nursing facility may not manage a resident's funds without an express written request from:</text> <paragraph num="(1)"> <text>The resident; or</text> </paragraph> <paragraph num="(2)"> <text>An agent who has legal authority to make decisions regarding the resident's funds.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Management of Personal Funds. Upon written authorization of a resident or agent, a nursing facility shall hold, safeguard, manage, and account for the resident's personal funds that are deposited with the nursing facility as specified in this regulation.</text> </paragraph> <paragraph num="D."> <text>Personal Funds in Excess of $50. A nursing facility shall:</text> <paragraph num="(1)"> <text>Deposit a resident's personal funds in excess of $50 in an interest-bearing account that is:</text> <paragraph num="(a)"> <text>Established and maintained by the facility under one of the following terms:</text> <paragraph num="(i)"> <text>In the name of the resident only;</text> </paragraph> <paragraph num="(ii)"> <text>In the name of the facility “in trust for” or as the “trustee” for the individual resident; or</text> </paragraph> <paragraph num="(iii)"> <text>In a residents' pooled account, with a separate accounting for each resident's share; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Located in a financial institution whose accounts are insured by the:</text> <paragraph num="(i)"> <text>Federal Deposit Insurance Corporation (FDIC);</text> </paragraph> <paragraph num="(ii)"> <text>Federal Savings and Loan Insurance Corporation (FSLIC); or</text> </paragraph> <paragraph num="(iii)"> <text>Other insurer approved by the Department; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Separate from any of the nursing facility's operating accounts; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Credit all interest earned to the resident's account at least quarterly.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Personal Funds Less Than $50. A nursing facility may maintain a resident's personal funds that do not exceed $50 in a petty cash fund or a non-interest-bearing account that is identified as a residents' account.</text> </paragraph> <paragraph num="F."> <text>Establishment of Resident Accounts. When a nursing facility manages a resident's financial affairs, the nursing facility shall establish and maintain a system that:</text> <paragraph num="(1)"> <text>Ensures a full, complete, and separate accounting, according to generally accepted accounting principles, of each resident's personal funds entrusted to the nursing facility; and</text> </paragraph> <paragraph num="(2)"> <text>Precludes any commingling of resident funds with the nursing facility funds.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For all resident funds entrusted to a nursing facility, the facility shall:</text> <paragraph num="(1)"> <text>Establish and maintain adequate fire and theft coverage to protect a resident's funds that are on the premises of the nursing facility; and</text> </paragraph> <paragraph num="(2)"> <text>Otherwise ensure the security of all residents' personal funds deposited with the nursing facility by purchasing a surety bond with the State as obligee on behalf of the nursing facility residents.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Limitation on Charges to Personal Funds. A nursing facility may not:</text> <paragraph num="(1)"> <text>Impose a charge against a resident's personal funds for:</text> <paragraph num="(a)"> <text>An item or service for which payment is made under Medicare or Medicaid; and</text> </paragraph> <paragraph num="(b)"> <text>A cost or fee incurred by the facility for establishing and servicing the resident's accounts; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Use a Medicaid resident's personal funds to offset a contribution of care debt unless authorized by the resident, the resident's agent, or a court.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Records of Resident Personal Funds."> <paragraph num="A."> <text>Records. For all resident funds entrusted to a nursing facility, the facility shall:</text> <paragraph num="(1)"> <text>Maintain an individual record for the funds of each resident, which includes the following information regarding each fund transaction:</text> <paragraph num="(a)"> <text>The date of the transaction;</text> </paragraph> <paragraph num="(b)"> <text>The type of transaction, whether it is a deposit, withdrawal, or any other transaction;</text> </paragraph> <paragraph num="(c)"> <text>When the transaction is a withdrawal or deposit, reference to a numbered receipt; and</text> </paragraph> <paragraph num="(d)"> <text>The balance of funds after the completion of the transaction;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least weekly, post to the record of the funds all deposits, withdrawals, and other transactions;</text> </paragraph> <paragraph num="(3)"> <text>Furnish each resident or, when applicable, the resident's agent or interested family member, with a quarterly statement of the resident's individual account not later than 30 days after the end of each quarter;</text> </paragraph> <paragraph num="(4)"> <text>Make available for inspection by the resident or, when applicable, the resident's agent or interested family member, a monthly statement of the resident's account; and</text> </paragraph> <paragraph num="(5)"> <text>Make available at the nursing facility, for audit by the Department and the Office, records pertaining to each resident's funds.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Receipts of Transactions.</text> <paragraph num="(1)"> <text>If a transaction involves a transfer of funds between a resident and a second party, or between the nursing facility and the institution in which the resident's account is located, the nursing facility or financial institution shall:</text> <paragraph num="(a)"> <text>Provide a receipt or copy of a receipt to the resident, or retain the resident's copy of the receipt as part of the resident's individual financial record; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the original receipt and make it available for audit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B(3) of this regulation, a nursing facility shall require that each receipt for withdrawal of funds from a resident's account be signed by the resident or, when applicable, the resident's agent.</text> </paragraph> <paragraph num="(3)"> <text>A nursing facility may allow a resident to withdraw money from the resident's account without signing a receipt only if the nursing facility documents that the resident is not disabled but is incapable of signing due to a physical disability.</text> </paragraph> <paragraph num="(4)"> <text>Except as set forth in Regulation .18H(2) of this chapter, a nursing facility may withdraw money from a resident's account without written authorization of the resident or, when applicable, the resident's agent, if the:</text> <paragraph num="(a)"> <text>Nursing facility documents that the resident is incapable of understanding the resident's rights and responsibilities regarding finances;</text> </paragraph> <paragraph num="(b)"> <text>Resident's agent is unavailable; and</text> </paragraph> <paragraph num="(c)"> <text>Withdrawal of funds is for an item or service needed for the resident's direct and immediate benefit and the facility maintains documentation that the withdrawal was used for that purpose.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A withdrawal under §B(4) of this regulation requires witness signatures of two facility employees authorized by the facility administrator.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Availability of Funds.</text> <paragraph num="(1)"> <text>A resident has the right to access funds entrusted to the nursing facility:</text> <paragraph num="(a)"> <text>During normal business hours, if the funds are held within the facility; or</text> </paragraph> <paragraph num="(b)"> <text>Within 3 banking days, if a bank, the State treasurer, or a county or municipal treasurer holds the money.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a nursing facility transfers or discharges a resident, the nursing facility shall either:</text> <paragraph num="(a)"> <text>Request and follow the resident's written instructions for transferring the money;</text> </paragraph> <paragraph num="(b)"> <text>Return, upon the resident's or, when applicable, the resident's agent's demand, the resident's money that the nursing facility has in its possession and have the resident or agent sign a receipt for the money; or</text> </paragraph> <paragraph num="(c)"> <text>Make available to the resident or the resident's agent, within 3 banking days, the resident's money which is in an account with a bank, the State treasurer, or county or municipal treasurer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notice of Balances. A nursing facility shall provide written notification to a resident who receives Medicaid benefits:</text> <paragraph num="(1)"> <text>As specified in §1611(a)(3)(B) of the Social Security Act when the amount in the resident's account reaches $200 less than the Supplemental Security Income (SSI) resource limit for one individual; and</text> </paragraph> <paragraph num="(2)"> <text>That, when the amount in the account, in addition to the value of the resident's other nonexempt resources, reaches the SSI resource limit for one individual, the resident may lose eligibility for Medicaid or SSI.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Death of a Resident. Upon the death of a resident for whom a nursing facility is holding funds, the nursing facility shall notify the resident's agent or interested family member and:</text> <paragraph num="(1)"> <text>Convey within 30 days a final accounting of the resident's personal funds which are deposited with the nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>Transfer, pursuant to the resident's preexisting burial contract, an amount not to exceed the outstanding unpaid balance of the contract, or the total of the resident's funds entrusted to the nursing facility, whichever is less;</text> </paragraph> <paragraph num="(3)"> <text>Release the resident's funds only to an individual who presents certified letters of administration that designate the person as “Representative of the Estate of _______________________________________”; and</text> </paragraph> <paragraph num="(4)"> <text>When the nursing facility is still in possession of a resident's funds 1 year after the resident's death, the facility shall report all money it holds for the former resident to the Unclaimed Property Section, Comptroller of the Treasury.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Misuse of Resident's Funds."> <paragraph num="A."> <text>A person may not misappropriate a resident's assets or income, including spending the resident's assets or income against or without the resident or resident's agent's consent, except as permitted by Regulation .19B(4) of this chapter.</text> </paragraph> <paragraph num="B."> <text>A person who believes that there has been an abuse of a resident's funds may make a complaint to the:</text> <paragraph num="(1)"> <text>Local department of social services;</text> </paragraph> <paragraph num="(2)"> <text>Director of the Office on Aging if the resident is 65 years old or older; or</text> </paragraph> <paragraph num="(3)"> <text>Director of the Licensing and Certification Administration, regardless of the resident's age.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 30, 1977 (4:27 Md. R. 2107)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 amended effective December 16, 1985 (12:25 Md. R. 2472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K and .03K adopted effective August 30, 1982 (9:17 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 30, 1982 (9:17 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 under COMAR 10.07.09 Patients' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities repealed and new Regulations .01—.20 under COMAR 10.07.09 Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities adopted effective April 22, 1996 (23:8 Md. R. 605)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 5, 2004 (30:26 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 5, 2004 (30:26 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective August 24, 2009 (36:17 Md. R. 1312)</annotation> </annotations> </chapter> <chapter num="10" heading="Home Health Agencies"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of these regulations is:</text> <paragraph num="A."> <text>To promote the interests and general well-being of all patients of home health agencies providing service within the State;</text> </paragraph> <paragraph num="B."> <text>To protect those interests by a public declaration of support for a patient's bill of rights; and</text> </paragraph> <paragraph num="C."> <text>To assure that the treatment of patients is, at all times, fully consistent with the provisions of this Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>All terms used in these regulations shall have the same meaning as those used in the Act.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrator” means an individual who has had:</text> <paragraph num="(a)"> <text>Formal education in health services or administration, as evidenced by being a:</text> <paragraph num="(i)"> <text>Physician,</text> </paragraph> <paragraph num="(ii)"> <text>Registered nurse, or</text> </paragraph> <paragraph num="(iii)"> <text>College graduate with a bachelor's or higher degree in a health-related field; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>At least 1 year of supervisory experience in:</text> <paragraph num="(i)"> <text>Hospital management,</text> </paragraph> <paragraph num="(ii)"> <text>Home health management, or</text> </paragraph> <paragraph num="(iii)"> <text>Public health program management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Clinical note” means a dated and signed notation, with service designation by a member of the health team, of a contact with a patient.</text> </paragraph> <paragraph num="(3)"> <text>“Clinical record” means a written account of all services provided a patient within the authorities of the home health agency, as well as other pertinent information necessary to provide care.</text> </paragraph> <paragraph num="(4)"> <text>“Consumer” means a resident of the geographic area served who has demonstrated an interest in health care. The consumer representative may not personally, or through direct family ties, have any financial or active professional interest in the operation of the agency and shall be free of the existence of or appearance of conflict of interest.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Governing authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation, and financial liability of the home health agency.</text> </paragraph> <paragraph num="(7)"> <text>“Home health agency” means a health-related institution, organization, or a part of an institution that:</text> <paragraph num="(a)"> <text>Is owned or operated by one or more persons, whether or not for profit and whether as a public or private enterprise; and</text> </paragraph> <paragraph num="(b)"> <text>Directly or through a contractual arrangement, provides to a sick or disabled individual in the residence of that individual skilled nursing services, home health aid services, and at least one other home health care service, that are centrally administered.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Home health aide” means a nonlicensed person who:</text> <paragraph num="(a)"> <text>Has:</text> <paragraph num="(i)"> <text>At least 1 year of practical experience in a hospital, nursing home, home care program; or</text> </paragraph> <paragraph num="(ii)"> <text>Satisfactorily completed the Maryland Red Cross Home Care Course or an equivalent program; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provides personal and health care services to an individual in the place of residence, under supervision of the appropriate health professional.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“In-home service” means a program provided by a home health agency which makes available personal care, homemaker, chore, or respite services to disabled or elderly persons in the place of residence. The services are designed to enable these persons to remain in their own residence consistent with their desires, abilities, and safety.</text> </paragraph> <paragraph num="(10)"> <text>“Maintenance health care” means a program provided by a home health agency for patients who are medically stable or have attained a satisfactory level of rehabilitation. These patients require only periodic monitoring by a health care professional in order to maintain their health care status and do not require the renewal of physician orders at least every 60 days.</text> </paragraph> <paragraph num="(11)"> <text>“Parent agency” means the agency that develops and maintains administrative and professional control of the delivery of services either directly or through branch offices.</text> </paragraph> <paragraph num="(12)"> <text>“Physician” means a person who is currently authorized to practice medicine under Health Occupations Article, §1-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Professional advisory group” means a committee which includes:</text> <paragraph num="(a)"> <text>One currently licensed physician;</text> </paragraph> <paragraph num="(b)"> <text>One registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>One representative providing input from each allied discipline utilized by the agency; and</text> </paragraph> <paragraph num="(d)"> <text>One consumer representative.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Progress note” means a dated written notation by a member of the health team summarizing facts about the care given and the patient's response during a given period of time.</text> </paragraph> <paragraph num="(15)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(16)"> <text>“Skilled care” means a service or services which can only be safely and effectively provided by a person licensed under Health Occupations Article, Annotated Code of Maryland, and exercising specialized knowledge, judgment, and skill.</text> </paragraph> <paragraph num="(17)"> <text>“Skilled nursing services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment.</text> </paragraph> <paragraph num="(18)"> <text>“Utilization review” means a medical record review procedure designed to evaluate:</text> <paragraph num="(a)"> <text>The appropriateness of admissions;</text> </paragraph> <paragraph num="(b)"> <text>The efficiency and adequacy of provided services; and</text> </paragraph> <paragraph num="(c)"> <text>Length of stay and discharge practices.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for a License."> <paragraph num="A."> <text>The applicant shall file an application for a license to operate a home health agency on forms provided by the Department.</text> </paragraph> <paragraph num="B."> <text>The application for licensure shall contain the name and address of each officer and director of the home health agency. Those corporations having more than 100 owners shall name those having an interest of 2 percent or more. Persons related by marriage or blood to the third degree of consanguinity shall each be named if the sum of their separate holdings exceeds 2 percent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Licensure Provisions."> <paragraph num="A."> <text>A person, partnership, corporation, or association, or any State or local government or agency thereof, may not conduct, operate, or maintain a home health agency in the State without being licensed by the Department. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="C."> <text>Renewal of License. An agency shall file an application on the written or electronic form provided by the Secretary for renewal of the license at least 60 days before expiration of the issued license and submit it on forms provided by the Secretary.</text> </paragraph> <paragraph num="D."> <text>The home health agency shall:</text> <paragraph num="(1)"> <text>Demonstrate compliance with all applicable federal, State, and local laws and regulations, including the requirement of Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Provide liability insurance to cover all employees. The agency shall also ensure that its contractual persons possess appropriate liability protection.</text> </paragraph> <paragraph num="(3)"> <text>Maintain records as determined by the Department and make the records available to the Department upon request.</text> </paragraph> <paragraph num="(4)"> <text>Accept patients for skilled care only on the signed order of a physician, obtained within 28 days after acceptance.</text> </paragraph> <paragraph num="(5)"> <text>Contact a physician to obtain a signed order as soon as possible, but not later than 10 days after acceptance of a patient for skilled care, and record all efforts to contact the physician.</text> </paragraph> <paragraph num="(6)"> <text>Adopt procedures for the administration of drugs and biologicals which shall include:</text> <paragraph num="(a)"> <text>The administration of treatment modalities, including any intravenous procedures, chemotherapy, parenteral feedings, and injections;</text> </paragraph> <paragraph num="(b)"> <text>The assurance of 24-hour-a-day availability of care for the hours during the administration of intravenous medications and nutritional support;</text> </paragraph> <paragraph num="(c)"> <text>The administration of drugs and treatments only by the following licensed agency staff:</text> <paragraph num="(i)"> <text>Physician,</text> </paragraph> <paragraph num="(ii)"> <text>Registered nurse, or</text> </paragraph> <paragraph num="(iii)"> <text>Licensed practical nurse if the drugs or treatments are administered under the supervision of a registered nurse in accordance with the physician's plan of treatment, and in accordance with a plan of care developed by a registered nurse;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Minimum training in keeping with applicable law for staff who administer drugs and treatments;</text> </paragraph> <paragraph num="(e)"> <text>Drugs and treatments to be administered only as ordered by the physician;</text> </paragraph> <paragraph num="(f)"> <text>Documentation in the patient's medical record of medications administered and any medication errors, adverse drug reactions, and corrective actions;</text> </paragraph> <paragraph num="(g)"> <text>If the agency provides to any patient controlled drugs as described in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, written policies and procedures governing the disposal of controlled drugs in accordance with applicable federal and State laws and regulations.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Have services available at least 8 hours a day, 5 days a week, and available on an emergency basis 24 hours a day, 7 days a week by:</text> <paragraph num="(a)"> <text>Establishing a procedure by which any patient may contact a representative of the agency at any time by telephone;</text> </paragraph> <paragraph num="(b)"> <text>Ensuring that the person receiving patient calls is able to contact a registered nurse immediately, but not later than 1/2 hour after receipt of a patient's call; and</text> </paragraph> <paragraph num="(c)"> <text>Ensuring that the registered nurse:</text> <paragraph num="(i)"> <text>Assesses the patient's needs; and</text> </paragraph> <paragraph num="(ii)"> <text>In emergency situations, renders immediate care to the patient, or causes the patient to be treated by an appropriate health care provider.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Issue its operating license only to the home health agency named in the application. The license may not be transferred or reassigned. The license shall be immediately void if the home health agency ceases to operate and shall be returned to the Department.</text> </paragraph> <paragraph num="(2)"> <text>Issue licenses which expire 1 year from the date of its issuance or, in the case of a provisional license, on the date specified at the time of issuance, unless otherwise revoked or suspended by the Department.</text> </paragraph> <paragraph num="(3)"> <text>Make inspections and surveys at least annually to determine compliance with the regulations.</text> </paragraph> <paragraph num="(4)"> <text>Conduct its inspections, surveys, and investigations at all reasonable times and at all geographical locations considered necessary for the proper conduct of its business.</text> </paragraph> <paragraph num="(5)"> <text>Prepare a written report detailing its determination of compliance with those regulations. A copy of this report shall be forwarded to the applicant within 30 days of the inspection.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If a parent agency is located outside the State, the Department shall issue a license if:</text> <paragraph num="(1)"> <text>At least one branch office is located within the State; or</text> </paragraph> <paragraph num="(2)"> <text>The parent agency is located in a state bordering Maryland and either the:</text> <paragraph num="(a)"> <text>Bordering state has a reciprocal agreement for home health licensure, under which the agency may be inspected at the discretion of the Department; or</text> </paragraph> <paragraph num="(b)"> <text>Agency agrees to be inspected by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Investigation of complaints shall be conducted by the Department as necessary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspections."> <text>A licensed home health agency or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving residents, for inspection by the Department or by any other agency designated by the Department to:</text> <paragraph num="A."> <text>Survey home health agencies at least every 3 years;</text> </paragraph> <paragraph num="B."> <text>Verify compliance with licensing regulations; or</text> </paragraph> <paragraph num="C."> <text>Investigate complaints.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Administrative Enforcement."> <paragraph num="A."> <text>When a home health agency fails to comply with these regulations, the Department may:</text> <paragraph num="(1)"> <text>Deny any application for a license;</text> </paragraph> <paragraph num="(2)"> <text>Suspend or revoke a license; or</text> </paragraph> <paragraph num="(3)"> <text>Issue a provisional license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Revocation, suspension, denial, or issuance of a provisional license shall occur in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department may issue a provisional license for a period of less than 1 year in instances where:</text> <paragraph num="(1)"> <text>The home health agency is in existence in Maryland at the time of promulgation of these regulations, and, therefore, requires a reasonable time period during which it may come into compliance with these regulations;</text> </paragraph> <paragraph num="(2)"> <text>The home health agency has failed to demonstrate substantial compliance with the regulations but has indicated, in writing, its willingness to take the necessary corrective action to achieve substantial compliance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall designate the conditions and the time period under which a provisional license is being issued.</text> </paragraph> <paragraph num="E."> <text>A provisional license may not be renewed unless the deficiencies have been substantially corrected or a satisfactory POC implemented. A provisional license may not be issued for more than 2 consecutive years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Notice to Patients."> <text>The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician, and any third-party payers at least 30 days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Posting of License."> <paragraph num="A."> <text>The home health agency shall conspicuously post its license in its office and in each of its branch offices. The license shall be posted as to be viewable by the general public.</text> </paragraph> <paragraph num="B."> <text>In branch offices, the license shall be accompanied by a Departmental statement affirming the authority of the branch office to conduct its activities under the licensure authority of its parent agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Governing Authority."> <paragraph num="A."> <text>The home health agency shall have a duly constituted governing body, or designated persons so functioning, with full legal authority, responsibility, and accountability for its operation.</text> </paragraph> <paragraph num="B."> <text>Adoption of By-laws.</text> <paragraph num="(1)"> <text>The governing body shall adopt written by-laws, in accordance with applicable legal requirements, for the conduct of business by the home health agency.</text> </paragraph> <paragraph num="(2)"> <text>These by-laws shall include, at least the following:</text> <paragraph num="(a)"> <text>A statement of objectives; and</text> </paragraph> <paragraph num="(b)"> <text>An organizational structure by which agency policies and procedures are implemented.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>These by-laws shall be reviewed annually and revised as necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The governing body shall appoint a home health agency administrator who shall be responsible for the overall management and fiscal operations of the agency.</text> </paragraph> <paragraph num="D."> <text>The governing body shall designate a “professional advisory group” whose functions shall include, at least:</text> <paragraph num="(1)"> <text>To regularly review and advise on agency policies covering professional issues, including:</text> <paragraph num="(a)"> <text>Scope of services offered;</text> </paragraph> <paragraph num="(b)"> <text>Criteria for acceptance, discharge and/or rejection of patients;</text> </paragraph> <paragraph num="(c)"> <text>Appropriateness of medical supervision;</text> </paragraph> <paragraph num="(d)"> <text>Emergency care services to patients;</text> </paragraph> <paragraph num="(e)"> <text>Adequacy of system for maintaining clinical records;</text> </paragraph> <paragraph num="(f)"> <text>Adequacy of agency's review and evaluation program; and</text> </paragraph> <paragraph num="(g)"> <text>Mechanism for referrals and continuity of care with allied health care providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To participate in the annual evaluation of the agency's programs.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Professional Advisory Group shall meet at least three times each calendar year and shall keep documented minutes.</text> </paragraph> <paragraph num="F."> <text>The governing body shall take appropriate actions on recommendations made by the professional advisory group. Complete documentation of recommendations made and actions taken shall be maintained.</text> </paragraph> <paragraph num="G."> <text>The governing body shall assure that all services offered by the home health agency, whether directly or indirectly, are:</text> <paragraph num="(1)"> <text>Monitored and supervised by the parent agency; and</text> </paragraph> <paragraph num="(2)"> <text>When stipulated by a physician's order, provided to an individual within 24 hours after the physician refers the individual to the agency.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The home health agency shall establish a written contractual arrangement for the provision of all services which are not provided directly by the agency. At a minimum, the written contract shall:</text> <paragraph num="(1)"> <text>Designate the services which are to be provided, the setting and the geographical area served (services provided are to be within the scope and limitations set forth in the plan of treatment and may not be altered in type, amount, frequency, or duration, except in the case of adverse reaction, by the individual under contract);</text> </paragraph> <paragraph num="(2)"> <text>Describe how the contracted personnel are to be administratively or professionally supervised, or both;</text> </paragraph> <paragraph num="(3)"> <text>Describe how services will be controlled, coordinated, and evaluated by the parent agency;</text> </paragraph> <paragraph num="(4)"> <text>Describe the procedure for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluations;</text> </paragraph> <paragraph num="(5)"> <text>Specify the charges for specific services provided under contract;</text> </paragraph> <paragraph num="(6)"> <text>Specify that only the parent agency shall bill for service and collect the applicable deductible or co-insurance payments;</text> </paragraph> <paragraph num="(7)"> <text>Specify the period of time that the contract shall be in effect and how frequently it shall be reviewed; the contract shall be reviewed at least annually and renewed when necessary;</text> </paragraph> <paragraph num="(8)"> <text>Insure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services, including licensure, personnel qualifications, physical examinations, functions, supervision, orientation, in-service education, and attendance at case conferences;</text> </paragraph> <paragraph num="(9)"> <text>Provide for the acceptance of patients for home health services only by the parent agency. Patients may not be admitted for home health service by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Personnel."> <paragraph num="A."> <text>All professional personnel employed by or conducting business with a home health agency shall be licensed or duly authorized to conduct the business under the laws and regulations of the State.</text> </paragraph> <paragraph num="B."> <text>The home health agency shall have written policies on qualifications, responsibilities, and requirements for employment for each classification of personnel, including licensure where required.</text> </paragraph> <paragraph num="C."> <text>The policies of the home health agency shall, at a minimum, provide for:</text> <paragraph num="(1)"> <text>Wage and salary schedules;</text> </paragraph> <paragraph num="(2)"> <text>Eligibility for vacation, sick leave, and other fringe benefits;</text> </paragraph> <paragraph num="(3)"> <text>In-service training and orientation of all personnel in the objectives, policies, and functions of the agency, including grievance procedures; and</text> </paragraph> <paragraph num="(4)"> <text>Job descriptions for each classification of personnel.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The policies of the home health agency shall be reviewed annually and revised as necessary.</text> </paragraph> <paragraph num="E."> <text>The home health agency shall maintain a complete and current personnel record for each employee and volunteer, which, at a minimum, shall include:</text> <paragraph num="(1)"> <text>A certification that the employee is free from tuberculosis in a communicable form as provided in Regulation .14, of this chapter, only if the employee or volunteer:</text> <paragraph num="(a)"> <text>Will be involved in the direct care of tuberculosis patients, or</text> </paragraph> <paragraph num="(b)"> <text>Is an immigrant from Africa, Asia, or Latin America;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evidence of current licensure, certification, or registration, as appropriate;</text> </paragraph> <paragraph num="(3)"> <text>Evidence of the individual's qualifications for the position; and</text> </paragraph> <paragraph num="(4)"> <text>Periodic performance evaluations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Staff Supervision and Training."> <paragraph num="A."> <text>The Administrator shall appoint a full-time employee as a “service director” to provide general supervision and direction of the professional services offered by the home health agency. The service director, who shall be a physician, registered nurse, or an alternate professional, who is sufficiently qualified by advance training to supervise this service, shall be available at all times during operating hours of the home health agency and shall participate in all activities related to the professional services provided, including the qualifications of personnel as related to their assigned duties. In his absence, he shall appoint a similarly qualified designee.</text> </paragraph> <paragraph num="B."> <text>The nursing services of the home health agencies shall be provided under the supervision and direction of a registered nurse who is qualified by having 2 to 3 years experience or education in community health nursing.</text> </paragraph> <paragraph num="C."> <text>There shall be periodic, on-site supervision of services provided by home health aides, with complete and accurate documentation maintained.</text> </paragraph> <paragraph num="D."> <text>Training Requirements for Home Health Aides. Aides shall receive a periodic, structured program of training and orientation which includes, at a minimum:</text> <paragraph num="(1)"> <text>The role of the home health aide as a member of the professional health services team;</text> </paragraph> <paragraph num="(2)"> <text>Instruction and supervised practice in personal care services of the sick at home, with major attention being given to personal hygiene and activities of daily living;</text> </paragraph> <paragraph num="(3)"> <text>Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living;</text> </paragraph> <paragraph num="(4)"> <text>Principles of good nutrition;</text> </paragraph> <paragraph num="(5)"> <text>Meal planning, food purchasing, and preparation of meals, including special diets;</text> </paragraph> <paragraph num="(6)"> <text>General information on the processes of growth, development, and aging;</text> </paragraph> <paragraph num="(7)"> <text>Information on the emotional and physical problems accompanying illness;</text> </paragraph> <paragraph num="(8)"> <text>Principles and practices in maintaining a clean, health, and safe environment as well as a pleasant one that encourages morale building and self-help;</text> </paragraph> <paragraph num="(9)"> <text>Items requiring referral to the nurse supervisor in the home health agency, including changes in the patient's condition or family situation;</text> </paragraph> <paragraph num="(10)"> <text>Record-keeping, when applicable;</text> </paragraph> <paragraph num="(11)"> <text>Policies and objectives of the agency;</text> </paragraph> <paragraph num="(12)"> <text>Information concerning the duties and responsibilities of a home health aide; and</text> </paragraph> <paragraph num="(13)"> <text>Ethical behavior and confidentiality of information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Inservice education is required for all professionals including home health aides, on a quarterly basis. The subject matter, content, and attendance shall be documented for review during the survey process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Clinical Records."> <paragraph num="A."> <text>A clinical record shall be maintained for each patient in accordance with accepted professional standards, including, at a minimum:</text> <paragraph num="(1)"> <text>All pertinent diagnoses;</text> </paragraph> <paragraph num="(2)"> <text>Name, address, and telephone number of physicians;</text> </paragraph> <paragraph num="(3)"> <text>Physician's orders, including specific instructions for services to be rendered, activities and limitations, and medically-necessary supplies and equipment;</text> </paragraph> <paragraph num="(4)"> <text>Drug information, including type, dosage, route of administration, frequency, and history of sensitivities or allergic reactions;</text> </paragraph> <paragraph num="(5)"> <text>Nutritional requirements, including specific dietary plans;</text> </paragraph> <paragraph num="(6)"> <text>Prognosis, including rehabilitation potential;</text> </paragraph> <paragraph num="(7)"> <text>Patient care plans, which should include:</text> <paragraph num="(a)"> <text>Long and short-range goals;</text> </paragraph> <paragraph num="(b)"> <text>Physical needs, including safety measures to protect against injury;</text> </paragraph> <paragraph num="(c)"> <text>Psycho-social needs;</text> </paragraph> <paragraph num="(d)"> <text>Actions taken by individual disciplines; and</text> </paragraph> <paragraph num="(e)"> <text>Evidence of periodic reappraisal of the needs of the patient;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Progress notes and modifications to the treatment plan; and</text> </paragraph> <paragraph num="(9)"> <text>Discharge summary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The home health agency should maintain a unit record for all patients receiving multi-disciplinary care.</text> </paragraph> <paragraph num="C."> <text>All notes and reports entered in the clinic record shall be typewritten or written in ink, legible, dated and signed with the name and title of the person rendering service.</text> </paragraph> <paragraph num="D."> <text>The home health agency shall establish and implement policies concerning clinical records which assure:</text> <paragraph num="(1)"> <text>That records of discharged patients are completed no later than 30 days after the date of discharge;</text> </paragraph> <paragraph num="(2)"> <text>The proper operation of a system for identifying, filing, and retrieving clinical records;</text> </paragraph> <paragraph num="(3)"> <text>Proper mechanisms for the timely transfer of clinical record information upon request from duly-authorized persons and organizations;</text> </paragraph> <paragraph num="(4)"> <text>Proper safeguards for clinical record information against loss, destruction, or illegal or unauthorized use;</text> </paragraph> <paragraph num="(5)"> <text>That clinical records are preserved for at least 5 years from the date of discharge;</text> </paragraph> <paragraph num="(6)"> <text>That, with the approval of the Department, provisions are made for retention of clinical records when it ceases operation; and</text> </paragraph> <paragraph num="(7)"> <text>That progress notes are recorded within 5 working days after service is delivered. The treatment plan shall be modified accordingly.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A home health agency which provides maintenance health care or in-home services, or both, may not be required to maintain the same level of supervisory and record-keeping requirements of these regulations for those patients who only receive the maintenance health or in-home services. In these cases, the agency shall develop performance criteria, supervisory and record-keeping requirements for these patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Program Review and Evaluation."> <paragraph num="A."> <text>The home health agency shall establish policies and procedures for self-evaluation of its programs. These should include, at a minimum:</text> <paragraph num="(1)"> <text>Evaluations of staffing patterns to assure adequacy and appropriateness of service delivered;</text> </paragraph> <paragraph num="(2)"> <text>An annual review of programs to determine:</text> <paragraph num="(a)"> <text>Trends in service needs and activities;</text> </paragraph> <paragraph num="(b)"> <text>Problems and unmet needs of patients;</text> </paragraph> <paragraph num="(c)"> <text>Anticipated changes in delivery of service;</text> </paragraph> <paragraph num="(d)"> <text>Linkages with related community services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the professional advisory group and to the governing body.</text> </paragraph> <paragraph num="C."> <text>Utilization Review.</text> <paragraph num="(1)"> <text>The home health agency shall establish a program of utilization review which, at a minimum, includes a utilization review committee to review clinical records at least quarterly. The committee members shall represent the scope of services offered by the agency. The clinical record review shall consist of a minimal sampling of 10 percent of unduplicated caseload records per annum or 40 records, whichever is less. All services offered shall be included in the sample.</text> </paragraph> <paragraph num="(2)"> <text>Sixty Day Continuous Care Review. Each active record shall be reviewed at least every 60 days to determine the adequacy of the plan of treatment and appropriateness of continued service, including renewal of physician orders.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The home health agency shall maintain a documented statistical reporting system for each county and the City of Baltimore, if served, which includes, at a minimum:</text> <paragraph num="(1)"> <text>Number of patients by age, sex, and race receiving each service;</text> </paragraph> <paragraph num="(2)"> <text>Number of patient visits conducted by each discipline;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic categories;</text> </paragraph> <paragraph num="(4)"> <text>Source of referrals;</text> </paragraph> <paragraph num="(5)"> <text>Reason for discharge; and</text> </paragraph> <paragraph num="(6)"> <text>Sources of reimbursement for all services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The home health agency shall:</text> <paragraph num="(1)"> <text>Prepare a report annually of its documented statistics within 90 days after the close of its fiscal year; and</text> </paragraph> <paragraph num="(2)"> <text>Beginning with the next fiscal year after adoption of this regulation, submit the report to the Department in the form and manner prescribed by the Secretary with each application for license renewal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Patient's Bill of Rights."> <paragraph num="A."> <text>The home health agency shall provide each patient, client, or designated representative with a written statement affirming the agency's representatives support of a patient's bill of rights, including:</text> <paragraph num="(1)"> <text>Upon request, a written statement of services offered, including frequency and unit charge;</text> </paragraph> <paragraph num="(2)"> <text>Fully itemized, billing statements, including date of service and unit charge, to be made available on request of the patient;</text> </paragraph> <paragraph num="(3)"> <text>Written disclosure of its policy on uncompensated care;</text> </paragraph> <paragraph num="(4)"> <text>Upon request, information as to the identity of other health care providers with which the agency has contractual relationships, insofar as the patient's home health care is concerned;</text> </paragraph> <paragraph num="(5)"> <text>The name of the responsible person supervising the patient's home health care and the manner in which that person may be contacted during regular working hours;</text> </paragraph> </paragraph> <paragraph num="B."> <text>To the extent reasonably possible, the home health agency shall provide for the patient's being consulted in the implementation of the home health care plan, including its likely outcome;</text> </paragraph> <paragraph num="C."> <text>The home health agency shall provide for the right of the patient to refuse any portion of planned treatment without relinquishing other portions of the treatment plan, except where medical contraindications to partial treatment exist;</text> </paragraph> <paragraph num="D."> <text>The home health agency shall provide a mechanism for the receipt and timely investigation of written complaints in which:</text> <paragraph num="(1)"> <text>Disruption in service may not result from the filing of a complaint;</text> </paragraph> <paragraph num="(2)"> <text>Complete files are maintained on the source, category, and disposition of the complaint;</text> </paragraph> <paragraph num="(3)"> <text>A summary report is presented to the professional advisory group at its regular meetings;</text> </paragraph> <paragraph num="(4)"> <text>A summary report is made available to the Department at least annually; and</text> </paragraph> <paragraph num="(5)"> <text>A summary report is made available for public inspection, upon request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Tuberculosis Screening."> <paragraph num="A."> <text>Certification of paid and unpaid personnel under Regulation .09E shall occur not later than 10 days after the beginning of service. Certification shall be accomplished in one of the following four ways as specified in §A(1)—(4), of this regulation:</text> <paragraph num="(1)"> <text>If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form following this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing is not necessary, except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department.</text> </paragraph> <paragraph num="(2)"> <text>If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done:</text> <paragraph num="(a)"> <text>Five tuberculin units (TU) of purified protein derivative (PPD) shall be administered intradermally and the results read 48—72 hours following the administration of the test;</text> </paragraph> <paragraph num="(b)"> <text>An individual with induration of 5—9 millimeters and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 millimeters shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form;</text> </paragraph> <paragraph num="(c)"> <text>An individual with induration of 5—9 millimeters and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 millimeters or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a)—(c), of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done:</text> <paragraph num="(a)"> <text>If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary.</text> </paragraph> <paragraph num="(b)"> <text>If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the individual's most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary.</text> </paragraph> <paragraph num="(c)"> <text>If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, further chest X-rays are not necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The agency shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms.</text> </paragraph> <paragraph num="C."> <text>If the individual meets any of the following criteria in this section, the agency shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual. The criteria include:</text> <paragraph num="(1)"> <text>A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer;</text> </paragraph> <paragraph num="(2)"> <text>Current treatment for tuberculosis disease or tuberculosis infection;</text> </paragraph> <paragraph num="(3)"> <text>Chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or</text> </paragraph> <paragraph num="(4)"> <text>Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The following records shall be maintained by the agency:</text> <paragraph num="(1)"> <text>Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading, and results of tests;</text> </paragraph> <paragraph num="(2)"> <text>Results of X-rays required in §A(3)(a)—(c), of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Rehabilitation Services."> <text>A home health agency that holds itself out to the public as providing a complete array of physical rehabilitation services shall:</text> <paragraph num="A."> <text>Provide a program of coordinated interdisciplinary rehabilitative care that shall include:</text> <paragraph num="(1)"> <text>Physical and occupational therapy,</text> </paragraph> <paragraph num="(2)"> <text>Speech and language therapy,</text> </paragraph> <paragraph num="(3)"> <text>Audiology therapy,</text> </paragraph> <paragraph num="(4)"> <text>Psychotherapy, and</text> </paragraph> <paragraph num="(5)"> <text>Social work services;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hold interdisciplinary meetings with the involvement of a physician to plan and monitor patient care; and</text> </paragraph> <paragraph num="C."> <text>Meet any other applicable standard required by law.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 2, 1978 (5:11 Md. R. 884)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 29, 1979 (6:13 Md. R. 1126); June 13, 1980 (7:12 Md. R. 1147); May 24, 1982 (9:10 Md. R. 1022)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective May 24, 1982 (9:10 Md. R. 1022)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 14, 1987 (14:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 11, 1994 (21:7 Md. R. 530)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 11, 1994 (21:7 Md. R. 530)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 1, 1989 (16:8 Md. R. 909); August 19, 1991 (18:16 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 6, 2016 (43:11 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, C amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="11" heading="Health Maintenance Organizations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The purpose of these regulations is to regulate various phases of the operations of health maintenance organizations in accordance with the mandates of Health-General Article, §§19-701—19-734, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(1-1)"> <text>“Certified nurse practitioner” has the meaning stated in Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Commissioner” means the Insurance Commissioner of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Enrollee” means a person who has entered into a health care services contract or on whose behalf a contractual arrangement has been entered into with a health maintenance organization (HMO).</text> </paragraph> <paragraph num="(5)"> <text>“Governing authority” means the person or persons designated in the bylaws with the responsibility for operating the HMO.</text> </paragraph> <paragraph num="(6)"> <text>“Grievance” means any complaint by an enrollee:</text> <paragraph num="(a)"> <text>That the enrollee has not received any benefit or other right to which the enrollee is contractually entitled or that the enrollee has been treated unprofessionally or otherwise improperly by the HMO, or a provider engaged by the HMO;</text> </paragraph> <paragraph num="(b)"> <text>Which is not resolved formally to the satisfaction of the enrollee.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Operating year” means the consecutive 12-month period, or part thereof, during which the HMO makes available health services as delineated in its Certificate of Authority (as issued by the Insurance Commissioner), and beginning on the issuance date of this Certificate.</text> </paragraph> <paragraph num="(8)"> <text>“Out-of-area coverage” means contractual benefits provided by the HMO to its enrollees with respect to emergency health care services received by enrollees outside the primary geographical area served by the HMO.</text> </paragraph> <paragraph num="(9)"> <text>“Physician” means an individual authorized by law to practice medicine in the State.</text> </paragraph> <paragraph num="(10)"> <text>“Preventive services” means those services designed to prevent the occurrence of disease or injury or to arrest disease at an early stage before complications and serious disabilities develop.</text> </paragraph> <paragraph num="(11)"> <text>“Quality of health care” means that level of health care delivered which reflects the general health care standards and practices in the geographical area served by the HMO.</text> </paragraph> <paragraph num="(12)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Service Requirements."> <paragraph num="A."> <text>The HMO shall provide the services required by the Maryland Health Maintenance Organization Act of 1975, Health-General Article, §19-701(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The HMO shall make available and encourage appropriate history and baseline examinations for each enrollee within a reasonable time of enrollment set by the HMO. Medical problems that are a potential hazard to the person's health shall be identified and a course of action to alleviate these problems outlined. Progress notes indicating success or failure of the course of action shall be recorded.</text> </paragraph> <paragraph num="C."> <text>The HMO shall offer or arrange for preventive services that include health education and counseling, early disease detection, and immunization. The HMO shall develop or arrange for periodic health education on subjects which impact on the health status of the enrollee population and shall notify every enrollee in writing of the availability of these and other preventive services.</text> </paragraph> <paragraph num="D."> <text>Services to prevent a disease shall be offered if all of the following conditions exist:</text> <paragraph num="(1)"> <text>The disease produces death or disability and exists in the enrolled population;</text> </paragraph> <paragraph num="(2)"> <text>The etiology of the disease is known or the disease can be detected at an early stage;</text> </paragraph> <paragraph num="(3)"> <text>Elimination of factors leading to the disease or immunization has been proven to prevent its occurrence, or early disease detection followed by behavior modification, environmental modification, or medical intervention has been proven to prevent death or disability.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An HMO shall offer services through a licensed health care practitioner who is not a physician if the:</text> <paragraph num="(1)"> <text>Services are within the scope of practice for both:</text> <paragraph num="(a)"> <text>A physician; and</text> </paragraph> <paragraph num="(b)"> <text>Another licensed health care practitioner; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>HMO considers the offering of the practitioner's services appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Quality Assurance Requirements — Program Planning and Evaluation."> <paragraph num="A."> <text>The HMO shall have a written program plan that is updated and reviewed at least every 3 years.</text> </paragraph> <paragraph num="B."> <text>The plan shall include the following information:</text> <paragraph num="(1)"> <text>Statistics on age, sex, and other general demographic data used to determine the health care needs of its population;</text> </paragraph> <paragraph num="(2)"> <text>Identification of the major health problems in the enrolled population;</text> </paragraph> <paragraph num="(3)"> <text>Identification of enrolled special groups that have unique health problems such as the poor, the elderly, the mentally ill, and educationally disadvantaged;</text> </paragraph> <paragraph num="(4)"> <text>A description of community health resources and how they will be used.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Priorities and Objectives. The HMO shall state its priorities and objectives in writing, describing how the priorities and objectives relating to the health problems and needs of the enrolled population will be provided for.</text> </paragraph> <paragraph num="D."> <text>Services. At the time membership is solicited, the HMO shall provide a general description of services available to enrollees including:</text> <paragraph num="(1)"> <text>Benefit limitations and exclusions;</text> </paragraph> <paragraph num="(2)"> <text>Location of facilities or providers; and</text> </paragraph> <paragraph num="(3)"> <text>Procedures by which a member would obtain medical services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>On each enrollment card or application, the HMO shall:</text> <paragraph num="(1)"> <text>Place the following statement in bold print: “If you have any questions concerning the benefits and services that are provided by or excluded under this agreement, please contact a membership services representative before signing this application or card”; and</text> </paragraph> <paragraph num="(2)"> <text>Provide information on how a prospective member may contact a membership services representative.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The plan shall contain evidence that:</text> <paragraph num="(1)"> <text>Programs and services offered are based on the health problems of, and the community health services available to, the enrolled population;</text> </paragraph> <paragraph num="(2)"> <text>There is an active program for preventing illness, disability, and hospitalization among enrollees;</text> </paragraph> <paragraph num="(3)"> <text>Services designed to prevent the major health problems identified among child and adult enrollees and to improve their general health are provided by the HMO.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Peer Review."> <paragraph num="A."> <text>Internal Review. The HMO shall have an internal peer review system that will evaluate the utilization of services and the quality of health care provided enrollees. The review system shall:</text> <paragraph num="(1)"> <text>Provide for review by appropriate health professionals of the process followed in the provision of health services;</text> </paragraph> <paragraph num="(2)"> <text>Use systematic data collection of performances and patient results;</text> </paragraph> <paragraph num="(3)"> <text>Provide interpretation of this data to the practitioners;</text> </paragraph> <paragraph num="(4)"> <text>Review and update continuing education programs for health professionals providing services to enrollees;</text> </paragraph> <paragraph num="(5)"> <text>Identify needed change and proposed modifications to implement;</text> </paragraph> <paragraph num="(6)"> <text>Maintain written records of the internal peer review process;</text> </paragraph> <paragraph num="(7)"> <text>Conduct focused studies directly related to major health problems and preventive health needs identified in Regulation .03B and C of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Assure that at least three focused studies related to the HMO specific plan under Regulation .03 of this chapter are conducted each year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>External Review.</text> <paragraph num="(1)"> <text>The Department shall conduct an external review of the quality of health care services of the HMO when and in a manner the Department considers appropriate.</text> </paragraph> <paragraph num="(2)"> <text>The external review shall be conducted by:</text> <paragraph num="(a)"> <text>A panel of physicians and other health professionals consisting of persons who:</text> <paragraph num="(i)"> <text>Have been approved by the Department;</text> </paragraph> <paragraph num="(ii)"> <text>Have substantial experience in the delivery of health care in an HMO setting but who are not members of the HMO staff or performing professional services for the HMO concerned;</text> </paragraph> <paragraph num="(iii)"> <text>Reside outside the area serviced by the HMO; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The final decision on which type of external review is to be employed rests solely with the Department.</text> </paragraph> <paragraph num="(4)"> <text>The external review shall consist of a review and evaluation of the following:</text> <paragraph num="(a)"> <text>Internal peer review system and reports;</text> </paragraph> <paragraph num="(b)"> <text>The HMO program plan to determine if it is adequate and being followed;</text> </paragraph> <paragraph num="(c)"> <text>The professional standards and practices of the HMO in every area of services provided;</text> </paragraph> <paragraph num="(d)"> <text>The grievances relating specifically to the delivery of medical care, including their final disposition;</text> </paragraph> <paragraph num="(e)"> <text>The physical facilities and equipment; and</text> </paragraph> <paragraph num="(f)"> <text>A statistically representative sample of enrollee records.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A health maintenance organization accredited by an accreditation organization approved by the Secretary in accordance with Health-General Article, §19—2302, Annotated Code of Maryland, shall be exempt from the external review.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Medical Records."> <paragraph num="A."> <text>The HMO shall maintain an individual record for each patient according to accepted professional principles and the provisions of these regulations, with entries kept current, dated, and signed by a physician or other medical professional.</text> </paragraph> <paragraph num="B."> <text>All information contained in the medical records and information received from physicians, surgeons, certified nurse practitioners, or hospitals, incident to the health care practitioner-patient or hospital-patient relationship, shall be kept confidential, and, except for use incident to bona fide medical research and education, or for the Department's review under these regulations, or as reasonably necessary in connection with the administration of the member's contract, may not be disclosed without the consent of the patient.</text> </paragraph> <paragraph num="C."> <text>Contents and Procedures. The medical record shall contain at least the following information and be maintained under the following procedures:</text> <paragraph num="(1)"> <text>Identification and summary sheets;</text> </paragraph> <paragraph num="(2)"> <text>Prior medical findings and referral information;</text> </paragraph> <paragraph num="(3)"> <text>Information necessary to support the diagnosis and justify the treatment given as shown in the individual written plan of treatment;</text> </paragraph> <paragraph num="(4)"> <text>Progress notes by a medical staff member, as appropriate; a physician shall review and approve the progress notes within 24 hours of entry;</text> </paragraph> <paragraph num="(5)"> <text>Dated record of all treatments, medications, laboratory tests, X-rays, operative reports, anesthesia records, and measurements;</text> </paragraph> <paragraph num="(6)"> <text>Consultation report, if appropriate;</text> </paragraph> <paragraph num="(7)"> <text>Record of any emergency care treatment rendered to patient; and</text> </paragraph> <paragraph num="(8)"> <text>Discharge summary of inpatient hospitalization to include condition at time of discharge and post operative instructions given to the patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>It is the responsibility of each attending clinical staff member to complete and sign the medical records of each ambulatory patient the staff member treats, within 72 hours of treatment.</text> </paragraph> <paragraph num="E."> <text>The HMO shall maintain a system for identifying and filing records which provides for:</text> <paragraph num="(1)"> <text>A universal identifier; and</text> </paragraph> <paragraph num="(2)"> <text>Adequate space and equipment for filing and prompt retrieval of medical records.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The HMO shall have established policies assuring that medical records of current enrollees and enrollees who leave the HMO plan are completed, promptly filed, and retained in safekeeping according to acceptable professional practices and State statutes.</text> </paragraph> <paragraph num="G."> <text>When the HMO provides services directly to its enrollees at several locations, it shall ensure, through the coordination of medical records and the use of other appropriate operating procedures, that the services it furnishes at those various locations are organized in this manner as to facilitate continuity of care. A central patient record keeping system shall be maintained as required by the Department.</text> </paragraph> <paragraph num="H."> <text>The HMO shall designate a member of the staff qualified by reason of training or experience, or both, who is responsible for the implementation of medical record policies and for the maintenance of the medical record system.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Statistics."> <text>The HMO shall provide the Department with full access to all operational and statistical data to enable the Department to verify the HMO's compliance and to enable the Department to conduct specific statistical studies with respect to current status of various segments of the enrolled population.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Personnel."> <paragraph num="A."> <text>When applicable, each staff member of the HMO shall be licensed as required by State and local law, and meet acceptable professional qualifications or have qualified by means of an occupational proficiency examination or through acceptable training. Provider staff patterns shall be designed to meet enrollee needs.</text> </paragraph> <paragraph num="B."> <text>The HMO shall provide orientation for all new employees and require continuing education of all professional and supportive personnel which reflects advances in medical knowledge and enrollee health education.</text> </paragraph> <paragraph num="C."> <text>The HMO shall establish a formal written process for:</text> <paragraph num="(1)"> <text>Appointment of a physician or certified nurse practitioner to the clinical staff of the HMO;</text> </paragraph> <paragraph num="(2)"> <text>Employment of a physician or certified nurse practitioner by the HMO; or</text> </paragraph> <paragraph num="(3)"> <text>Selection of a physician or certified nurse practitioner to provide services to the enrollees under contract with the HMO.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Information Concerning a Physician's or Certified Nurse Practitioner's Background and Training.</text> <paragraph num="(1)"> <text>As part of the formal written process in §C of this regulation, the HMO shall collect, review, and verify the information concerning a physician's or certified nurse practitioner's background and training in §D(2) and (3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Information that shall be collected, reviewed, and verified for a physician or certified nurse practitioner includes:</text> <paragraph num="(a)"> <text>Evidence of education;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of current license to practice in the State;</text> </paragraph> <paragraph num="(c)"> <text>Evidence of internship, residency training, or other pertinent training;</text> </paragraph> <paragraph num="(d)"> <text>Evidence of specialty certification;</text> </paragraph> <paragraph num="(e)"> <text>Evidence of Drug Enforcement Administration or Controlled Dangerous Substances registration;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of malpractice insurance coverage;</text> </paragraph> <paragraph num="(g)"> <text>Physical and mental status;</text> </paragraph> <paragraph num="(h)"> <text>List of all hospitals where the physician or certified nurse practitioner has current privileges or is employed;</text> </paragraph> <paragraph num="(i)"> <text>Evidence of any adverse action or restriction of privileges imposed by any hospital or Board;</text> </paragraph> <paragraph num="(j)"> <text>Delineation of services to be provided to patients at the HMO;</text> </paragraph> <paragraph num="(k)"> <text>Past malpractice claims history;</text> </paragraph> <paragraph num="(l)"> <text>Verification of status through the federal National Practitioner Data Bank; and</text> </paragraph> <paragraph num="(m)"> <text>Cooperative arrangement with a physician for each certified nurse practitioner.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a physician who has privileges in a licensed Maryland hospital, the HMO may verify, through the hospital, the credentials described in §D(2)(a)—(f) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reevaluation of Physicians or Certified Nurse Practitioners.</text> <paragraph num="(1)"> <text>The HMO shall establish a formal written process for the reevaluation of appointment, employment, or selection of a physician or certified nurse practitioner.</text> </paragraph> <paragraph num="(2)"> <text>The reevaluation shall include an ongoing process for verifying:</text> <paragraph num="(a)"> <text>Current State Licensure;</text> </paragraph> <paragraph num="(b)"> <text>Current Controlled Dangerous Substances or Drug Enforcement Administration registration; and</text> </paragraph> <paragraph num="(c)"> <text>Evidence of current malpractice insurance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Every 3 years, the reevaluation also shall include the following for all physicians and certified nurse practitioners:</text> <paragraph num="(a)"> <text>An update of the requirements of §D of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>An assessment of the performance pattern based on an analysis of:</text> <paragraph num="(i)"> <text>Complaints filed through the grievance system;</text> </paragraph> <paragraph num="(ii)"> <text>Malpractice claims filed;</text> </paragraph> <paragraph num="(iii)"> <text>Utilization, quality, and risk data;</text> </paragraph> <paragraph num="(iv)"> <text>Adherence to policies, bylaws, and procedures; and</text> </paragraph> <paragraph num="(v)"> <text>Physician and certified nurse practitioner practice patterns as reviewed through the HMO's quality assurance program.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Administrator.</text> <paragraph num="(1)"> <text>At least one administrator shall be appointed by the governing body and delegated the responsibility for the internal operation of the HMO according to established policies. The administrator's responsibility for procurement and direction of personnel shall be clearly defined. An individual competent and authorized to act in the absence of the administrator shall be designated.</text> </paragraph> <paragraph num="(2)"> <text>The HMO shall notify the Department of the name of the person appointed administrator and of any change in the appointment.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Medical Director. The HMO shall have a medical director who is licensed to practice medicine in the State. A physician authorized to act in the absence of the medical director shall be designated. The medical director shall oversee the quality of care provided to the HMO's patients. If the medical director becomes aware of unethical or unprofessional conduct on the part of any health provider, the medical director shall take appropriate action to prevent future occurrences of this conduct.</text> </paragraph> <paragraph num="H."> <text>The HMO shall have a licensed registered nurse present to perform nursing services at all times that these services are required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Policy Formulation."> <paragraph num="A."> <text>The HMO shall have written policies governing the provision of the HMO services according to stated objectives of the HMO. The policies shall be developed in consultation with the executive officer, representative professionals, including one or more physicians, nursing service personnel associated with the service, and one or more enrollee representative or representatives. Policies shall be approved by the governing authority and reviewed and revised annually as required. These approvals shall be affirmed in writing and dated by an authorized representative of the governing authority.</text> </paragraph> <paragraph num="B."> <text>Patient Care Policies. The policies shall cover at least the following:</text> <paragraph num="(1)"> <text>Inpatient admission and discharge policies;</text> </paragraph> <paragraph num="(2)"> <text>Physician (Independent Practice Association) services, including medical staff organization;</text> </paragraph> <paragraph num="(3)"> <text>Provision of or arrangements for other services not directly provided by the HMO;</text> </paragraph> <paragraph num="(4)"> <text>Continuity and availability of care through an established referral mechanism and ongoing contract with other health services providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Access and Availability of Services."> <paragraph num="A."> <text>Regular Hours.</text> <paragraph num="(1)"> <text>With respect to all services it furnishes, whether direct or through contractual arrangements, an HMO shall provide for regular hours during which an enrollee may receive services.</text> </paragraph> <paragraph num="(2)"> <text>An HMO that provides services directly to its enrollees through its staff members shall have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services.</text> </paragraph> <paragraph num="(3)"> <text>An HMO that provides services to its enrollees through independent licensed health care providers under contract with the HMO shall ensure that the providers have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Outside of Regular Hours. The HMO shall have a system for providing the enrollee with 24-hour access to a physician in cases where there is an immediate need for medical services. To meet this requirement, the HMO's arrangements for off-hour services may provide for access to physicians who do not have a contract with the HMO and facilities such as hospital emergency rooms. When a physician who does not have a contract with the HMO is used, the HMO shall develop and publicize procedures assuring that the HMO is notified of the services and receives adequate documentation from the physician or facility within a reasonable period of time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Physician Availability."> <paragraph num="A."> <text>The HMO shall have a physician available at all times to provide diagnostic and treatment services. The HMO shall assure that every enrollee seen for a medical complaint is evaluated under the direction of a physician and that every enrollee receiving diagnostic evaluation or treatment is under the direct medical management of an HMO physician who provides continuing medical management.</text> </paragraph> <paragraph num="B."> <text>Each enrollee shall have an opportunity to select a primary physician or certified nurse practitioner from among those available to the HMO.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Complaint System for Quality of Care Issues."> <paragraph num="A."> <text>The HMO shall have a:</text> <paragraph num="(1)"> <text>Written procedure to assist and respond to enrollees, families, and providers on complaints concerning quality of care issues; and</text> </paragraph> <paragraph num="(2)"> <text>Designated department to handle complaints.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Quality of care issues include, but are not necessarily limited to:</text> <paragraph num="(1)"> <text>Bad outcomes related to poor care;</text> </paragraph> <paragraph num="(2)"> <text>Failure to follow-up on diagnostic procedures;</text> </paragraph> <paragraph num="(3)"> <text>Failure to provide treatment for presenting complaints consistent with standard of care;</text> </paragraph> <paragraph num="(4)"> <text>Failure to appropriately document medical records;</text> </paragraph> <paragraph num="(5)"> <text>Confidentiality and privacy issues related to medical records or provision of care;</text> </paragraph> <paragraph num="(6)"> <text>General dissatisfaction with care;</text> </paragraph> <paragraph num="(7)"> <text>Qualifications of individuals who are:</text> <paragraph num="(a)"> <text>Employees of the HMO; or</text> </paragraph> <paragraph num="(b)"> <text>Under contract with the HMO to provide services to enrollees;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Misdiagnosis;</text> </paragraph> <paragraph num="(9)"> <text>Inappropriate referral to meet enrollees' needs;</text> </paragraph> <paragraph num="(10)"> <text>Environmental issues related to infection control and hazardous medical waste;</text> </paragraph> <paragraph num="(11)"> <text>Failure of a provider to perform adequate medical screening, assessments, or timely care in emergency situations;</text> </paragraph> <paragraph num="(12)"> <text>Failure to provide an adequate internal enrollee complaint process concerning quality of care issues;</text> </paragraph> <paragraph num="(13)"> <text>Failure to comply with policies and procedures concerning delivery of care; or</text> </paragraph> <paragraph num="(14)"> <text>Inadequate credentialing and performance appraisal for physicians.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The HMO shall:</text> <paragraph num="(1)"> <text>Submit the written procedure to the Department for approval before distributing to enrollees;</text> </paragraph> <paragraph num="(2)"> <text>Obtain Departmental approval of any revision to the written procedure before implementing the proposed change; and</text> </paragraph> <paragraph num="(3)"> <text>Distribute the approved written procedure to all enrollees.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The written complaint procedure shall include, at a minimum, the:</text> <paragraph num="(1)"> <text>Department of the HMO that the enrollee or family member may contact if the enrollee wishes to make a complaint or obtain information concerning a complaint;</text> </paragraph> <paragraph num="(2)"> <text>Complaint department's address and telephone number;</text> </paragraph> <paragraph num="(3)"> <text>Procedure for investigating the complaint;</text> </paragraph> <paragraph num="(4)"> <text>Time frame in which the HMO shall provide a final response to or resolve the enrollee's complaint, not to exceed 60 days; and</text> </paragraph> <paragraph num="(5)"> <text>Telephone number of the Maryland Insurance Administration if the enrollee wishes to pursue a complaint regarding quality of care issues outside of the HMO's complaint system.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The HMO shall treat the enrollee with dignity, courtesy, and due regard for the individual's privacy.</text> </paragraph> <paragraph num="F."> <text>The HMO shall maintain a written record of complaints and responses for at least 5 years following the date the complaint was received by the HMO.</text> </paragraph> <paragraph num="G."> <text>Investigation by the Department.</text> <paragraph num="(1)"> <text>The Maryland Insurance Administration is the single point of entry for all complaints to State government filed by an HMO enrollee. The Maryland Insurance Administration shall refer all quality of care complaints, as defined in §B of this regulation, to the Department for investigation.</text> </paragraph> <paragraph num="(2)"> <text>The Department may:</text> <paragraph num="(a)"> <text>Refer a complaint directly to an HMO for resolution; or</text> </paragraph> <paragraph num="(b)"> <text>Conduct an independent investigation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Department refers the complaint to an HMO, the HMO shall provide the following information in writing to the Department within 30 days of receipt of the complaint:</text> <paragraph num="(a)"> <text>The results of the investigation;</text> </paragraph> <paragraph num="(b)"> <text>Any change or proposed change to HMO policies or procedures as a result of the investigation; and</text> </paragraph> <paragraph num="(c)"> <text>The HMO's method to prevent recurrence of the problem.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the HMO has not completed the investigation within 30 days, the HMO shall send the Department an interim report with a summary of the investigation to date and the expected date of completion. The expected date of completion may not be longer than 60 days from receipt of the complaint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Inspections."> <paragraph num="A."> <text>HMO to Be Open for Inspection. An HMO shall be open to inspection by representatives of the Department and by any agency designated by the Department.</text> </paragraph> <paragraph num="B."> <text>Frequency of Inspection.</text> <paragraph num="(1)"> <text>The Department shall inspect each HMO periodically at reasonable times.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall monitor continuously the health care services of an HMO:</text> <paragraph num="(a)"> <text>From the time of notice by the Commissioner that the HMO is not operating in a fiscally sound manner; and</text> </paragraph> <paragraph num="(b)"> <text>Until:</text> <paragraph num="(i)"> <text>The Commissioner notifies the Department that the HMO is operating in a fiscally sound manner; and</text> </paragraph> <paragraph num="(ii)"> <text>The Secretary determines that further continuous monitoring is not warranted.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Records and Reports. HMO's shall keep records and shall make reports as the Department shall prescribe. All records shall be open to inspection by representatives of the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Repealed." /> <regulation prefix="Regulation" num=".14" heading="Waiver Authority."> <text>The Department may grant waivers to the provisions of these regulations when this action is demonstrated to be in the best interests of the general public. Waivers may be granted for a 1-year period, are renewable, and are subject to reconsideration at any time.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-701 et seq.; Insurance Article, §2-109(a)—(c); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 16, 1978 (5:12 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01E, .02, .03. .04B. .05D, .07E, .09B, .10B, .11A, .12B and C amended effective June 29, 1987 (14:13 Md. R. 1472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 22, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 recodified to Regulation .01-1 and the Scope paragraph codified as Regulation .01 in May, 1993</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1B amended effective December 9, 2004 (31:24 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 22, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 9, 2004 (31:24 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 22, 1992 (19:12 Md. R. 1134); December 9, 2004 (31:24 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and new Regulation .11 adopted as an emergency provision effective March 3, 1999 (26:7 Md. R. 535); emergency status expired September 3, 1999; adopted permanently effective September 6, 1999 (26:18 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D and E adopted effective June 22, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 repealed effective June 22, 1992 (19:12 Md. R. 1134)</annotation> </annotations> </chapter> <chapter num="12" heading="Health Care Facilities Within Correctional Institutions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations are applicable to all health care facilities within correctional institutions and include those services provided inmates who report to the health care facility on an out-patient basis. These regulations do not include infirmaries which do not house patients overnight.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>“Communicable disease programs” means the provision of services that will assist in the prevention of communicable disease.</text> </paragraph> <paragraph num="B."> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="C."> <text>“Health care facility” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections.</text> </paragraph> <paragraph num="D."> <text>“Health care program” means a document prepared by the facility and approved by the Department which lists the following:</text> <paragraph num="(1)"> <text>The number of beds;</text> </paragraph> <paragraph num="(2)"> <text>Organizational structure;</text> </paragraph> <paragraph num="(3)"> <text>A description of the care, treatment, and services provided for inmates;</text> </paragraph> <paragraph num="(4)"> <text>Admission policies;</text> </paragraph> <paragraph num="(5)"> <text>Discharge and referral policies and procedures;</text> </paragraph> <paragraph num="(6)"> <text>The staffing pattern by shifts;</text> </paragraph> <paragraph num="(7)"> <text>The job classification and job descriptions of each employee.</text> </paragraph> </paragraph> <paragraph num="E."> <text>“Inpatient” means an inmate not requiring acute hospital care but requiring services of licensed nursing personnel or supportive services which he cannot perform for himself.</text> </paragraph> <paragraph num="F."> <text>“Referred services” means those appropriate services provided to inmates based on individual medical needs in the area of psychiatric services, dental care, or emergency care.</text> </paragraph> <paragraph num="G."> <text>“Sick call” means the medical care provided to inmates not classified as inpatients but who have expressed a need for medical attention or who have been referred to the health care facility by the appropriate personnel in the correctional institution.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Compliance with State and Local Laws, Ordinances, Regulations, or Orders."> <paragraph num="A."> <text>Each correctional facility shall demonstrate to the Department its compliance with applicable State and local ordinances, laws, regulations, and orders as they apply to the use of facilities for health, welfare and safety.</text> </paragraph> <paragraph num="B."> <text>Fire code requirements shall be:</text> <paragraph num="(1)"> <text>In accordance with the NFPA 101 Life Safety Code as adopted as part of the State Fire Prevention Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Annual inspection and approval by the State fire authority.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Procedure."> <text>Applicants for licensure shall conform to the following:</text> <paragraph num="A."> <text>Any person desiring to open and operate a health care facility within a correctional institution or to continue the operation of an existing health care facility, shall file a written or electronic application with the Department giving the information required by the Office of Health Care Quality;</text> </paragraph> <paragraph num="B."> <text>The applicant shall submit a synopsis of the health care program to be offered with the application; each subsequent application shall include a list of changes in the original program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Transfer or Assignment of License."> <paragraph num="A."> <text>Transfer or assignment of the license is prohibited.</text> </paragraph> <paragraph num="B."> <text>A separate license shall be required for each health care facility operated within the correctional institution.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inspections."> <paragraph num="A."> <text>Health Care Facility to be Open for Inspection. Health care facilities, and any premise proposed to be operated by an applicant for a license, shall be open at all reasonable times to inspection by the Secretary of Health and by any agency designated by the Secretary of Health.</text> </paragraph> <paragraph num="B."> <text>Frequency of Inspection. Health care facilities shall be inspected by the Secretary of Health at least once during each 1-year period for which a license is granted to determine whether the health care facility is complying with the minimum standards established pursuant to these regulations.</text> </paragraph> <paragraph num="C."> <text>Records and Reports. All records shall be open to inspection by authorized representatives of the Department. Except where authentication may be required, the disclosure of patient names to the Division of Licensing and Certification surveyor may not be required. The representatives of the Department shall maintain confidentiality of all the data disclosed to them.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Policies and Procedures."> <text>Written policies and procedures shall be established for the following services:</text> <paragraph num="A."> <text>Physician services;</text> </paragraph> <paragraph num="B."> <text>Health care services;</text> </paragraph> <paragraph num="C."> <text>Staffing;</text> </paragraph> <paragraph num="D."> <text>Emergency care;</text> </paragraph> <paragraph num="E."> <text>Medical research;</text> </paragraph> <paragraph num="F."> <text>Communicable diseases;</text> </paragraph> <paragraph num="G."> <text>Medical examinations and evaluation process;</text> </paragraph> <paragraph num="H."> <text>Pharmacy services;</text> </paragraph> <paragraph num="I."> <text>Dietary services;</text> </paragraph> <paragraph num="J."> <text>Nursing Services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Communication."> <text>There shall be a telephone in the health unit and additional telephones or extensions or communication systems as required by the Department to summon help in case of fire or other emergency.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Physician Services."> <paragraph num="A."> <text>Medical Examination. Each newly received inmate to the health facility shall be examined within 2 working days after his admission as to his medical condition. A record of each examination shall be kept as part of the permanent medical record.</text> </paragraph> <paragraph num="B."> <text>Availability. A licensed physician shall be readily available to take care of the medical needs of the inmates. Physician services may be provided through the following arrangements:</text> <paragraph num="(1)"> <text>A contract with a local physician to provide coverage on specified hours and for emergencies; or</text> </paragraph> <paragraph num="(2)"> <text>Affiliation with a local hospital to provide medical services required by the health care facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Psychiatric Services."> <text>Psychiatric services shall be provided according to the needs of the patients.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Surgical Services."> <text>Each health care facility desiring to perform surgical procedures shall first obtain approval from the Department.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Health Care Services."> <paragraph num="A."> <text>Health care services shall be provided according to the needs of the inmates and shall be designed to maintain the highest possible degree of function, self-care, and independence.</text> </paragraph> <paragraph num="B."> <text>A health care program shall be developed to insure prompt treatment of injury or illness.</text> </paragraph> <paragraph num="C."> <text>The health care facility shall provide equipment necessary for medical care according to the needs of the patients.</text> </paragraph> <paragraph num="D."> <text>An individual medical record shall be maintained for each patient. The record shall indicate their condition at the time of admission, reports of illness and injury, medical treatment provided, results of treatment, and their condition at the time of discharge.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Staffing."> <paragraph num="A."> <text>The health facility shall provide the number and level of personnel sufficient to meet the total needs of the patient.</text> </paragraph> <paragraph num="B."> <text>Health facilities shall employ licensed personnel to provide medical services when applicable.</text> </paragraph> <paragraph num="C."> <text>The facility shall provide personnel who are qualified by both training and experience in the handling of health emergencies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Emergency Care."> <text>Each health facility in cooperation with the facility physician shall set forth in writing, to all personnel, the routine procedure for summoning appropriate medical care personnel.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Medical Research."> <text>Each health facility involved in medical research shall follow standards developed by the American Correctional Association for the safety and well-being of the inmate population.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Communicable Disease."> <paragraph num="A."> <text>Cross-infection shall be guarded against by prompt isolation of diagnosed and suspected cases of communicable disease. Room furnishings, equipment, and supplies shall be kept clean at all times, properly cleaned after use, and disinfected.</text> </paragraph> <paragraph num="B."> <text>Reports of Disease. The occurrence of an infectious disease, food poisoning, or dysentery, shall be reported immediately by the examining physician to the local health department and to the Division of Licensing and Certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Medical Examination and Evaluation Process."> <paragraph num="A."> <text>Written policies and procedures shall be developed and maintained in consultation with representatives of the medical staff, nursing service, and administration governing the provisions for the control of the sick call process and referral services. They shall address the following:</text> <paragraph num="(1)"> <text>Screening Procedures.</text> <paragraph num="(a)"> <text>Routine handling of patient complaints;</text> </paragraph> <paragraph num="(b)"> <text>Non-routine handling of patient complaints.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Reporting Procedure. A responsible staff member to whom an inmate can report injuries, symptoms of illness, and emergencies shall be on duty at all times and be immediately accessible.</text> </paragraph> <paragraph num="(3)"> <text>Complaint Procedure. Complaints of illness or injury shall be recorded in the inmate's clinical record together with the treatment prescribed.</text> </paragraph> <paragraph num="(4)"> <text>Examination Procedure. The procedure shall specify where the examination area is located as well as who is to perform the examination.</text> </paragraph> <paragraph num="(5)"> <text>Procedures to be followed by the correctional officer in attendance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Staff Development."> <paragraph num="A."> <text>There shall be a combined orientation and continuing education program at least every 2 months for all personnel. Documentation shall be available to include date, time, topic discussed, speaker, and members present. A coordinated training program with a local hospital is encouraged.</text> </paragraph> <paragraph num="B."> <text>There shall be health care orientation and training for correctional officers assigned to medical facilities. Assignments and activities of correctional officers in medical areas shall be established.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Pharmacy Services."> <paragraph num="A."> <text>Procedures for Administration of Pharmaceutical Services. Each facility shall comply with all federal, State, and local laws, ordinances, standards and codes regulating the purchasing, storage, dispensing, administration, and recording of drugs. Each health care facility shall:</text> <paragraph num="(1)"> <text>Ensure that pharmaceutical services are provided;</text> </paragraph> <paragraph num="(2)"> <text>Make provision for prompt and convenient acquisition of prescribed drugs;</text> </paragraph> <paragraph num="(3)"> <text>Record all supplies and drugs requisitioned and received from the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>Record all prescriptions dispensed;</text> </paragraph> <paragraph num="(5)"> <text>Obtain a permit to operate a pharmacy from the Board of Pharmacy in the State if the pharmacy is located within the correctional facility;</text> </paragraph> <paragraph num="(6)"> <text>If the facility has no pharmacy, there shall be a written agreement for qualified pharmacy services, including provision for emergency service and consultation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Requirements.</text> <paragraph num="(1)"> <text>Pharmaceutical service, when provided within the health care facility, shall be under the direction and supervision of a pharmacist licensed to practice pharmacy in the State.</text> </paragraph> <paragraph num="(2)"> <text>The staff or consultant pharmacist at each correctional facility shall participate in planned inservice education programs for the facility on topics related to pharmaceutical services.</text> </paragraph> <paragraph num="(3)"> <text>The consultant pharmacist shall be available to assist in formulating the procedures, rules, and regulations for the acceptable distribution of drugs throughout the correctional system and shall visit the facility on a regular basis to review all aspects of the services provided and to ensure that proper controls are maintained.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Formulary. There shall be a formulary system, approved by the institutional physician and pharmacist and by other appropriate facility staff. Copies of the formulary shall be located and available as appropriate to the institution.</text> </paragraph> <paragraph num="D."> <text>Space and Equipment. If the pharmacy is located within the health care facility there shall be adequate space and equipment to house the drugs and supplies. The pharmacist and pharmacy personnel, under the direct supervision of the pharmacist, may not dispense medications, make label changes, or transfer medications on other than the original containers. Documentation of the qualifications of the pharmacy personnel shall be available.</text> </paragraph> <paragraph num="E."> <text>Emergency Kit. There shall be an emergency drug kit immediately available at each nursing or service area for use by medical personnel. Written policies and procedures establishing the contents of the supply and procedures establishing the contents of the supply and procedures for use, restocking, and sealing of the emergency drug supply shall be available. A list of drugs shall be signed by the pharmacist and physician and attached to the kit.</text> </paragraph> <paragraph num="F."> <text>Stop Order Policy. Automatic stop orders on all drugs shall be maintained by the medical and pharmacy staff. These orders may not apply when the physician indicates a specific period of time a drug is to be used, or a specific number of dosages.</text> </paragraph> <paragraph num="G."> <text>Medication Release. All medications to be released to the patient shall be approved in writing by the physician. A notation concerning their disposition shall be made on the patient's clinical record.</text> </paragraph> <paragraph num="H."> <text>Administration of Medications.</text> <paragraph num="(1)"> <text>All medications shall be administered by licensed medical or nursing personnel or by personnel who possess written documentation of training in theory and practice in the administration of medications. This written documentation shall be available for review by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The person assigned the responsibility of administering medications to inpatients shall complete the procedure by:</text> <paragraph num="(a)"> <text>Personally preparing the dose;</text> </paragraph> <paragraph num="(b)"> <text>Observing the act of swallowing the oral medications;</text> </paragraph> <paragraph num="(c)"> <text>Recording the act of administration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the case of unit dose medications the person administering medication shall:</text> <paragraph num="(a)"> <text>Open the unit dose package;</text> </paragraph> <paragraph num="(b)"> <text>Observe the taking and swallowing of the medication;</text> </paragraph> <paragraph num="(c)"> <text>Record the administration of the medication.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Medication shall be given only to the individual patient for whom the prescription was issued and shall be given according to directions as prescribed.</text> </paragraph> <paragraph num="(5)"> <text>Medication cards and lists, or acceptable substitutes, shall be used and checked against the physician's orders when administering medications to inpatients.</text> </paragraph> <paragraph num="(6)"> <text>Self-administration of medications by patients shall be permitted only when specifically ordered by the attending physician.</text> </paragraph> <paragraph num="(7)"> <text>Medication errors and drug reactions shall be reported to the physician responsible for the resident. An entry of the medication error or the drug reaction or a combination of both, shall be recorded in the patient's record.</text> </paragraph> <paragraph num="(8)"> <text>Current pharmaceutical reference materials shall be provided in order to furnish the medical, pharmacy, and nursing staffs with current information concerning the drugs used in the hospital.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Investigational Drugs. Investigational drugs, properly labeled according to federal regulations, may be used only under the direct supervision of the principal investigator and after written consent is obtained from the patient. The drugs shall be approved by an appropriate medical staff committee acting according to established policies and procedures. Only physicians and nurses may administer investigative drugs after they have been made aware of the essential pharmacologic information necessary for them to discharge their professional responsibilities. A central location shall be established where information on investigational drugs being used is maintained.</text> </paragraph> <paragraph num="J."> <text>Labeling and Storing of Medication.</text> <paragraph num="(1)"> <text>All medications shall be properly labeled and stored in a locked cabinet at the medical unit. The key to this cabinet shall be in the possession of authorized personnel. The labels shall bear the name and strength of the drug, expiration date of all time-dated drugs, name of the pharmacy issuing the drug, name of patient, and federal and State cautionary statements. Necessary labels shall be affixed to the labeled container.</text> </paragraph> <paragraph num="(2)"> <text>Medications requiring refrigeration shall be kept in a locked refrigerator. Poisons and medication for “external use only”, including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications.</text> </paragraph> <paragraph num="(3)"> <text>Discontinued and outdated drugs, and containers with worn, illegible, or missing labels, shall be returned to the pharmacy for proper disposition.</text> </paragraph> <paragraph num="(4)"> <text>A drug recall procedure shall be established that can be readily implemented.</text> </paragraph> <paragraph num="(5)"> <text>Drug cabinets on the medical units shall be checked by the pharmacist at least every 2 months.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Control of Schedule II and Legend Drugs.</text> <paragraph num="(1)"> <text>All Schedule II drugs shall be kept in a separately locked, securely fastened compartment within the locked medicine cabinet.</text> </paragraph> <paragraph num="(2)"> <text>All Schedule II drugs retained on each nursing unit shall be counted at the termination of each tour of duty. This record shall be signed by both the outgoing and incoming professional nurse or authorized person. Schedule II drugs which are outdated and no longer in use shall be disposed of according to federal regulations. All other discontinued or outdated drugs shall be disposed of according to State regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Dietary Services."> <paragraph num="A."> <text>Adequacy of Diet. The food and nutritional needs of patients shall be met according to physician's orders.</text> </paragraph> <paragraph num="B."> <text>Therapeutic Diets.</text> <paragraph num="(1)"> <text>The therapeutic diet prescribed by the attending physician shall be prepared and served as part of the course of treatment of the patient. If the dietary requirement is beyond the capability of the facility, other arrangements for the nutritional needs shall be made by the health care facility physician.</text> </paragraph> <paragraph num="(2)"> <text>A diet manual approved by the physician or dietitian shall be available.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Frequency and Quality of Meals. At least three meals or their equivalent shall be served daily, at regular times, with not more than a 14-hour interval between the evening meal and breakfast.</text> </paragraph> <paragraph num="D."> <text>Planning of Menus. Menus shall be planned in advance and food sufficient to meet the nutritional needs of residents shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value.</text> </paragraph> <paragraph num="E."> <text>Preparation of Food. Food shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperature.</text> </paragraph> <paragraph num="F."> <text>Compliance with COMAR 10.15.03 Food Service Facilities. Food service personnel shall comply with Maryland Department of Health COMAR 10.15.03 Food Service Facilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Housekeeping Services and Pest Control."> <text>The following shall be observed:</text> <paragraph num="A."> <text>The building and all its parts shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness.</text> </paragraph> <paragraph num="B."> <text>All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning.</text> </paragraph> <paragraph num="C."> <text>The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items.</text> </paragraph> <paragraph num="D."> <text>The facility shall be maintained free of insects, rodents, and harborages, by operation of an active pest-control program, either by use of facility personnel or by contract with a pest-control company. Care shall be exercised in the usage and storage of toxic and flammable insecticides and rodenticides.</text> </paragraph> <paragraph num="E."> <text>All outside doors, windows, and other outside openings shall be screened with wire screen or its equal of at least 16 meshes per linear inch.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-307, 19-308, 19-320, and 19-323, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 16, 1978 (5:12 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="13" heading="Forensic Residential Centers (FRCs)"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth requirements for a facility to be licensed as a forensic residential center.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Confined” means an order by the court pursuant to Criminal Procedure Article, §3-106(d)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Court-ordered evaluation” means an evaluation ordered by the court under Criminal Procedure Article, §§3-105 and 3-111, Annotated Code of Maryland, to assist the court to determine if an individual is incompetent to stand trial or is not criminally responsible because of mental retardation.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Evaluation unit” means a part of the forensic residential center dedicated to performing court-ordered evaluations pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Forensic residential center (FRC)” means a facility that is:</text> <paragraph num="(a)"> <text>Licensed to provide a continuum of integrative services to individuals with an intellectual disability:</text> <paragraph num="(i)"> <text>Ordered by the court for an evaluation or to be confined;</text> </paragraph> <paragraph num="(ii)"> <text>Court-committed for care or treatment to the Department as incompetent to stand trial or not criminally responsible, who are dangerous as a result of mental retardation; or</text> </paragraph> <paragraph num="(iii)"> <text>On conditional release and returned to the facility either voluntarily or on hospital warrant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A related institution as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Not an extended care or comprehensive rehabilitation facility.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Incompetent to stand trial (IST)” has the meaning set forth in Criminal Procedure Article, §3-101(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Not criminally responsible (NCR)” means a verdict of not criminally responsible as set forth in Criminal Procedure Article, §3-109, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Qualified developmental disabilities professional (QDDP)” means an individual who coordinates and monitors the delivery of services for individuals with an intellectual disability.</text> </paragraph> <paragraph num="(9)"> <text>“Therapeutic care unit” means an FRC or part of an FRC dedicated to providing care or treatment to individuals who are court-committed or confined.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedure."> <paragraph num="A."> <text>The Secretary shall license an FRC that meets the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The license for an FRC shall be effective for 1 year.</text> </paragraph> <paragraph num="C."> <text>The Secretary may renew the license of an FRC if it continues to meet the requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>Approval, Denial, Revocation, and Sanctions.</text> <paragraph num="(1)"> <text>The Secretary may deny an application, suspend, revoke, or impose disciplinary sanctions on the license of an FRC if it fails to comply with the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Any action to deny an application, suspend, revoke, or impose sanctions on a license shall be governed by COMAR 10.22.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Administrative Requirements."> <paragraph num="A."> <text>In addition to the requirements of this chapter, an FRC shall comply with the applicable requirements of COMAR 10.22.02.</text> </paragraph> <paragraph num="B."> <text>Safety and Sanitation.</text> <paragraph num="(1)"> <text>An FRC's grounds, fixtures, and equipment shall:</text> <paragraph num="(a)"> <text>Be maintained in good repair and be clean and attractive;</text> </paragraph> <paragraph num="(b)"> <text>Be free of unnecessary accumulations of personal property or debris;</text> </paragraph> <paragraph num="(c)"> <text>Be free of hazards, insects, and rodents; and</text> </paragraph> <paragraph num="(d)"> <text>Be free from fire hazards.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An FRC shall comply with all applicable local fire and building codes and the Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Living Space. An FRC shall:</text> <paragraph num="(1)"> <text>Have bedrooms that:</text> <paragraph num="(a)"> <text>Have at least one outside wall;</text> </paragraph> <paragraph num="(b)"> <text>Are equipped with or located near toilet and bathing facilities;</text> </paragraph> <paragraph num="(c)"> <text>Accommodate no more than two individuals, provided such arrangement is clinically appropriate; and</text> </paragraph> <paragraph num="(d)"> <text>Measure at least:</text> <paragraph num="(i)"> <text>60 square feet per individual in multiple individuals' bedrooms; and</text> </paragraph> <paragraph num="(ii)"> <text>80 square feet in single individual's bedrooms;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have adequate bathroom facilities and maintain water temperature that does not exceed 110 degrees Fahrenheit in areas where individuals do not demonstrate the capability to regulate water temperature;</text> </paragraph> <paragraph num="(3)"> <text>Provide adequate space and equipment for dining, living, health and therapeutic services, recreation, and other program activities; and</text> </paragraph> <paragraph num="(4)"> <text>Provide that the above described living space be:</text> <paragraph num="(a)"> <text>Dedicated to the sole use of individuals committed for court evaluation or committed or confined pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Separate from areas used, frequented, or occupied by individuals committed or admitted pursuant to Health-General Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Infection Control. The FRC shall:</text> <paragraph num="(1)"> <text>Establish policies and procedures to investigate, control, and prevent infections in the facility;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that facility staff follows these policies and procedures; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain records of actions taken to address and prevent infections.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Food Services. The FRC shall employ a qualified dietitian either full-time or part-time, or on a consultant basis at the facility's discretion, who shall:</text> <paragraph num="(1)"> <text>Provide adequate food and nutrition services;</text> </paragraph> <paragraph num="(2)"> <text>Provide individuals with a nourishing, well-balanced diet including modified and specially prescribed diets;</text> </paragraph> <paragraph num="(3)"> <text>Ensure the diet is prepared in accordance with current clinical dietary standards;</text> </paragraph> <paragraph num="(4)"> <text>Ensure individuals receive at least three meals a day, at regular normal meal times;</text> </paragraph> <paragraph num="(5)"> <text>Ensure foods are served in variety, appropriate consistency, texture, quantity, in season, and at appropriate temperatures; and</text> </paragraph> <paragraph num="(6)"> <text>Prepare menus in advance and keep them on file a minimum 30 days.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Health Care Services. As clinically appropriate, an FRC shall provide health services for all residents including, but not limited to:</text> <paragraph num="(1)"> <text>Physician services, 24 hours a day;</text> </paragraph> <paragraph num="(2)"> <text>Annual physical examinations which include:</text> <paragraph num="(a)"> <text>Vision evaluations; and</text> </paragraph> <paragraph num="(b)"> <text>Hearing evaluations;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Immunizations;</text> </paragraph> <paragraph num="(4)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(5)"> <text>Nursing services and delegated nursing services in compliance with COMAR 10.27.11;</text> </paragraph> <paragraph num="(6)"> <text>Medical care or nursing care plans for each individual and reviews of each plan;</text> </paragraph> <paragraph num="(7)"> <text>Dental care;</text> </paragraph> <paragraph num="(8)"> <text>Pharmacy services; and</text> </paragraph> <paragraph num="(9)"> <text>Training or supervision of individuals to:</text> <paragraph num="(a)"> <text>Self administer medications;</text> </paragraph> <paragraph num="(b)"> <text>Perform routine treatments; and</text> </paragraph> <paragraph num="(c)"> <text>Provide for their health care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Personnel and Staffing.</text> <paragraph num="(1)"> <text>The administrator of an FRC shall:</text> <paragraph num="(a)"> <text>Ensure appropriate employee health screenings; and</text> </paragraph> <paragraph num="(b)"> <text>Obtain certification that an employee or volunteer is free from tuberculosis in a communicable form only if the employee or volunteer will be involved in the direct care of tuberculosis patients.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An FRC shall provide an adequate staffing plan in accordance with COMAR 10.22.02.11 to meet the needs of individuals served.</text> </paragraph> <paragraph num="(3)"> <text>An FRC shall employ a Maryland licensed psychologist as the supervising psychologist who shall:</text> <paragraph num="(a)"> <text>Supervise the evaluation and therapeutic treatment of individuals;</text> </paragraph> <paragraph num="(b)"> <text>Use clinical best practices for the FRC population;</text> </paragraph> <paragraph num="(c)"> <text>Have relevant work experiences and training in conducting and completing functional analyses, assessments, and behavior plans including experience working with individuals with co-occurring diagnoses of mental illness, substance abuse, and an intellectual disability;</text> </paragraph> <paragraph num="(d)"> <text>Train direct care staff to collect data, and implement behavior plans and other programs in the individual's plan;</text> </paragraph> <paragraph num="(e)"> <text>Ensure all services provided are documented appropriately in the individual's record; and</text> </paragraph> <paragraph num="(f)"> <text>Ensure all behavior plans are developed in accordance with COMAR 10.22.10.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An FRC shall employ a Maryland licensed physician who:</text> <paragraph num="(a)"> <text>Is certified in psychiatry by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to be qualified to take the Board examination; and</text> </paragraph> <paragraph num="(b)"> <text>Has the relevant work experience in providing psychiatric services to individuals with an intellectual disability and co-occurring disorders including mental disorders and addiction diseases.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An FRC shall employ direct care staff who develop and implement an activity schedule for the individual that includes at a minimum:</text> <paragraph num="(a)"> <text>The individual's preferred activities;</text> </paragraph> <paragraph num="(b)"> <text>Opportunities for recreation and social activities;</text> </paragraph> <paragraph num="(c)"> <text>Times for meals;</text> </paragraph> <paragraph num="(d)"> <text>Training as indicated in the individual's plan; and</text> </paragraph> <paragraph num="(e)"> <text>The individual's waking and bedtime hours.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An FRC shall employ a Maryland licensed registered nurse to:</text> <paragraph num="(a)"> <text>Train direct care staff on an individual's nursing care needs and any delegated nursing services; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure all services provided are documented in the individual's plan.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The FRC shall have a clinical team that shall include, at a minimum:</text> <paragraph num="(a)"> <text>A Maryland licensed psychologist;</text> </paragraph> <paragraph num="(b)"> <text>A Maryland licensed certified social worker—clinical (LCSW-C);</text> </paragraph> <paragraph num="(c)"> <text>A QDDP;</text> </paragraph> <paragraph num="(d)"> <text>Direct care staff;</text> </paragraph> <paragraph num="(e)"> <text>A Maryland licensed registered nurse; and</text> </paragraph> <paragraph num="(f)"> <text>As necessary:</text> <paragraph num="(i)"> <text>A psychiatrist;</text> </paragraph> <paragraph num="(ii)"> <text>A physician; or</text> </paragraph> <paragraph num="(iii)"> <text>Other licensed staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Security and Restrictions.</text> <paragraph num="(1)"> <text>A resident may have access to personal electronic devices according to the resident's individual plan.</text> </paragraph> <paragraph num="(2)"> <text>A resident may not have access to or possess:</text> <paragraph num="(a)"> <text>Illegal products;</text> </paragraph> <paragraph num="(b)"> <text>Cigarettes, alcohol, or pornography; or</text> </paragraph> <paragraph num="(c)"> <text>Items or objects that the supervising psychologist documents in the individual's record as contraindicated or designates as dangerous to the individual or others.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The administrator of an FRC shall ensure a safe and secure setting for individuals by providing:</text> <paragraph num="(a)"> <text>Adequate staffing;</text> </paragraph> <paragraph num="(b)"> <text>Adequate supervision of individuals;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate training for staff to perform their job duties competently; and</text> </paragraph> <paragraph num="(d)"> <text>Designated visitors' rooms with appropriate supervision of individuals during visits as needed.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The administrator of an FRC may utilize the following environmental security measures:</text> <paragraph num="(a)"> <text>Security doors and windows;</text> </paragraph> <paragraph num="(b)"> <text>Security screens;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate locks;</text> </paragraph> <paragraph num="(d)"> <text>Alarm systems;</text> </paragraph> <paragraph num="(e)"> <text>Electronic monitoring devices;</text> </paragraph> <paragraph num="(f)"> <text>Video monitoring systems;</text> </paragraph> <paragraph num="(g)"> <text>Outdoor gates and fences with locks; and</text> </paragraph> <paragraph num="(h)"> <text>Enclosed or locked patios.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A resident's rights to communications and restrictions of communications are set forth in Health-General Article, §10-702, Annotated Code of Maryland, and adopted herein.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Emergency Management Plans. The administrator of an FRC shall develop an emergency plan for all types of emergencies and disasters in accordance with COMAR 10.07.20.05E.</text> </paragraph> <paragraph num="J."> <text>Standing Committee Approval. An FRC shall assure that the quality assurance standing committee reviews all behavioral plans in accordance with COMAR 10.22.02.14E.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Enrollment, Release, and Discharge."> <paragraph num="A."> <text>All individuals in an FRC are ordered or committed by the court to the Department, or under the court's jurisdiction pursuant to an order of conditional release as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An individual on conditional release who voluntarily agrees to admission to a therapeutic care unit shall be admitted as set forth in the conditional release order.</text> </paragraph> <paragraph num="C."> <text>Release From an FRC.</text> <paragraph num="(1)"> <text>Individuals court ordered for evaluation shall be released from the evaluation unit as set forth in Criminal Procedure Article, §3-105 or 3-111, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Individuals committed as IST or NCR shall be released as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Confined individuals shall be discharged as set forth in Health-General Article, §7-503(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>Individuals admitted pursuant to a hospital warrant shall be discharged as set forth in Criminal Procedure Article, §3-121, Annotated Code of Maryland.</text> </paragraph> <paragraph num="F."> <text>Individuals who voluntarily admit themselves pursuant to a conditional release order shall be discharged as set forth in the conditional release order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Services."> <paragraph num="A."> <text>Services provided by an FRC shall include:</text> <paragraph num="(1)"> <text>As set forth in Criminal Procedure, Title 3, Annotated Code of Maryland, all required evaluations and reports; and</text> </paragraph> <paragraph num="(2)"> <text>Therapeutic services designed to prepare the individual for productive community living, that address issues of dangerousness, and are based on an interdisciplinary team assessment considering least restrictive interventions, include but are not limited to:</text> <paragraph num="(a)"> <text>For individuals committed as IST, competency attainment services; and</text> </paragraph> <paragraph num="(b)"> <text>For all individuals, services as set forth in the Individual Plan and, as clinically appropriate, therapeutic services include, but are not limited to:</text> <paragraph num="(i)"> <text>Behavioral and mental health plans and services;</text> </paragraph> <paragraph num="(ii)"> <text>Physical, speech, and occupational therapies;</text> </paragraph> <paragraph num="(iii)"> <text>Habilitation services including vocational, educational, and life skills training; or</text> </paragraph> <paragraph num="(iv)"> <text>Development of an aftercare or services plan.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Therapeutic services for all individuals shall be conducted in space not simultaneously shared or used with individuals who are not residents of the FRC.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-102 and 7-904; Criminal Procedure Article, §3-102; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; adopted permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> </annotations> </chapter> <chapter num="14" heading="Assisted Living Programs"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to set minimum, reasonable standards for licensure of assisted living programs in Maryland. This chapter is intended to maximize independence and promote the principles of individuality, personal dignity, freedom of choice, and fairness for all individuals residing in assisted living programs while establishing reasonable standards to promote individuals’ health and safety.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abuse of a Resident.</text> <paragraph num="(a)"> <text>“Abuse of a resident” means physical, sexual, mental, or verbal abuse, or the improper use of a physical or chemical restraint or involuntary seclusion as those terms are defined in this regulation.</text> </paragraph> <paragraph num="(b)"> <text>“Abuse of a resident” does not include:</text> <paragraph num="(i)"> <text>The performance of an accepted medical procedure ordered by a health care practitioner practicing within the scope of their license;</text> </paragraph> <paragraph num="(ii)"> <text>Compliance with a valid advance directive; or</text> </paragraph> <paragraph num="(iii)"> <text>Honoring a resident’s known wishes regarding medical care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Activities of Daily Living.</text> <paragraph num="(a)"> <text>“Activities of daily living” means normal daily activities.</text> </paragraph> <paragraph num="(b)"> <text>“Activities of daily living” includes:</text> <paragraph num="(i)"> <text>Eating or being fed;</text> </paragraph> <paragraph num="(ii)"> <text>Grooming, bathing, and oral hygiene, including brushing teeth, shaving, and combing hair;</text> </paragraph> <paragraph num="(iii)"> <text>Mobility, transfer, ambulation, and access to the outdoors, when appropriate;</text> </paragraph> <paragraph num="(iv)"> <text>Toileting; and</text> </paragraph> <paragraph num="(v)"> <text>Dressing in clean, weather-appropriate clothing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Administration of Medication.</text> <paragraph num="(a)"> <text>“Administration of medication” means the act of preparing and giving a medication to a resident.</text> </paragraph> <paragraph num="(b)"> <text>“Administration of medication” includes:</text> <paragraph num="(i)"> <text>Identifying the time to administer the medication;</text> </paragraph> <paragraph num="(ii)"> <text>Opening the medication container;</text> </paragraph> <paragraph num="(iii)"> <text>Removing the medication from the container;</text> </paragraph> <paragraph num="(iv)"> <text>Giving the medication to the resident.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Administration of medication” does not include residents who have the cognitive ability to recognize their medications but only require assistance such as:</text> <paragraph num="(i)"> <text>A reminder to take the medication;</text> </paragraph> <paragraph num="(ii)"> <text>Physical assistance with opening a medication container; or</text> </paragraph> <paragraph num="(iii)"> <text>Assistance with removing medication from the container.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Adult medical day care” has the meaning stated in Health-General Article, 14-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Advance directive” means:</text> <paragraph num="(a)"> <text>A written or electronic document, voluntarily executed by the declarant consistent with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A witnessed oral statement, made by the declarant consistent with the provisions of the Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Alzheimer’s Special Care Unit” means a secured or separated special unit specifically designed for individuals with any type of dementia, including a probable or confirmed diagnosis of Alzheimer’s disease and related dementias.</text> </paragraph> <paragraph num="(7)"> <text>“Assessment” means a process of evaluating an individual’s health, functional and psychosocial history, and condition using the Resident Assessment Tool.</text> </paragraph> <paragraph num="(8)"> <text>“Assist rail” means a hand rail or other similar, substantially constructed device that is installed to enable residents to move safely from one point or position to another.</text> </paragraph> <paragraph num="(9)"> <text>“Assisted living manager” means the individual who is:</text> <paragraph num="(a)"> <text>Designated by an assisted living program to oversee the overall and day-to-day operation of the assisted living program; and</text> </paragraph> <paragraph num="(b)"> <text>Responsible for the duties set forth in Regulation .15 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Assisted Living Program.</text> <paragraph num="(a)"> <text>“Assisted living program” means a residential or facility-based program for two or more residents that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals.</text> </paragraph> <paragraph num="(b)"> <text>“Assisted living program” does not include:</text> <paragraph num="(i)"> <text>A nursing facility, as defined under Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>Services provided by family members;</text> </paragraph> <paragraph num="(vi)"> <text>Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or</text> </paragraph> <paragraph num="(vii)"> <text>A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Human Services Article, §§6-508—6-513, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Authorized prescriber” means an individual who is authorized to prescribe medications under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Background check” means a check of court and other records by a private agency.</text> </paragraph> <paragraph num="(13)"> <text>“Bank” means a bank, trust company, savings bank, savings and loan association, or financial institution that is:</text> <paragraph num="(a)"> <text>Authorized to do business in this State; and</text> </paragraph> <paragraph num="(b)"> <text>Insured by the Federal Deposit Insurance Corporation.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Certified medication technician” means an individual who is certified as a medication technician by the Maryland Board of Nursing under COMAR 10.39.04.</text> </paragraph> <paragraph num="(15)"> <text>“Chemical restraint” means controlling behavior by use of a drug that is not otherwise required to treat medical symptoms.</text> </paragraph> <paragraph num="(16)"> <text>Cognitive Impairment.</text> <paragraph num="(a)"> <text>“Cognitive impairment” means the loss of those thought processes that orchestrate relatively simple ideas, movements, or actions into goal-directed behavior.</text> </paragraph> <paragraph num="(b)"> <text>“Cognitive impairment” includes lack of judgment, planning, organization, self-control, and the persistence needed to manage normal demands of the individual’s environment.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Common ownership community” means:</text> <paragraph num="(a)"> <text>A condominium organized under Real Property Article, Title 11, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A homeowners association organized under Real Property Article, Title 11B, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>A cooperative housing corporation organized under Corporations and Associations Article, Title 5, Subtitle 6B, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Common-use telephone” means a telephone that is:</text> <paragraph num="(a)"> <text>Within the facility;</text> </paragraph> <paragraph num="(b)"> <text>Accessible to residents;</text> </paragraph> <paragraph num="(c)"> <text>Located so that residents can have private conversations; and</text> </paragraph> <paragraph num="(d)"> <text>Available to residents to make free local calls.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Consultant” means an individual or organization, under contract with a licensee, that may:</text> <paragraph num="(a)"> <text>Have partial or full responsibility and control over one or more areas of operations of the assisted living provider; and</text> </paragraph> <paragraph num="(b)"> <text>Provide expertise related to:</text> <paragraph num="(i)"> <text>One or more licensure requirements; or</text> </paragraph> <paragraph num="(ii)"> <text>Standards of care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Contact precautions” means the use of a private room, if available, and appropriate personal protective equipment, such as gowns, gloves, or masks to prevent the transmission of certain organisms between an infected individual and others.</text> </paragraph> <paragraph num="(21)"> <text>“Controlled dangerous substance (CDS)” means a medication or substance listed in Schedule I through Schedule V as defined in Criminal Law Article, §5-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Criminal history records check” means a check of criminal history information, as defined in Criminal Procedure Article, §10-201, Annotated Code of Maryland, by the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(23)"> <text>“Delegating nurse” means a nurse who:</text> <paragraph num="(a)"> <text>Is licensed to practice registered nursing in this State as defined in Health Occupations Article, Title 8, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Has successfully completed the Board of Nursing’s approved training program for registered nurses, delegating nurses, and case managers in assisted living.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Delegation of nursing tasks” means the formal process approved by the Maryland Board of Nursing which permits a professional nurse to assign nursing tasks to an unlicensed individual, a certified nursing assistant, or a medication technician, in accordance with COMAR 10.27.11.03, through:</text> <paragraph num="(a)"> <text>A nursing assessment of the patient’s nursing care needs prior to delegation of tasks;</text> </paragraph> <paragraph num="(b)"> <text>Instructing the unlicensed individual, certified nursing assistant, or medication technician, or verifying their competency;</text> </paragraph> <paragraph num="(c)"> <text>Supervising of the delegated task in accordance with COMAR 10.27.11.04;</text> </paragraph> <paragraph num="(d)"> <text>Retaining accountability and responsibility for the delegated task;</text> </paragraph> <paragraph num="(e)"> <text>Evaluating the performance of the delegated task; and</text> </paragraph> <paragraph num="(f)"> <text>Assuring accurate documentation of outcomes on the nursing record.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(26)"> <text>“Discharge” means releasing a resident from an assisted living program, after which the releasing program no longer is responsible for the resident’s care.</text> </paragraph> <paragraph num="(27)"> <text>“Emergency admission” means the temporary admittance of an individual in an assisted living program when the individual’s health and safety would be jeopardized by not permitting immediate admittance.</text> </paragraph> <paragraph num="(28)"> <text>“Emergency Medical Services form” means a form issued by the Maryland Institute for Emergency Medical Services Systems for the purpose of documenting emergency medical services and do not resuscitate orders as defined in Health-General Article, §5-601(k), Annotated Code of Maryland, including a Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form.</text> </paragraph> <paragraph num="(29)"> <text>Facilitating Access.</text> <paragraph num="(a)"> <text>“Facilitating access” means:</text> <paragraph num="(i)"> <text>Making appropriate referrals for care and treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Arranging for the appointment and involvement of appropriate health care decision makers, when necessary; and</text> </paragraph> <paragraph num="(iii)"> <text>Facilitating contact between the resident, the resident representative, the health care or social service professional, and needed services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Facilitating access” does not mean guaranteeing payment for services that are not:</text> <paragraph num="(i)"> <text>Covered by the resident agreement; or</text> </paragraph> <paragraph num="(ii)"> <text>Paid for by the resident or the resident agent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Facility” means the physical plant in which an assisted living program is operated.</text> </paragraph> <paragraph num="(31)"> <text>“Family” means a group of two or more individuals related by legal status or affection who consider themselves a family.</text> </paragraph> <paragraph num="(32)"> <text>“Family council” means a group of individuals who work together to protect the rights of and improve the quality of life for residents of an assisted living program.</text> </paragraph> <paragraph num="(33)"> <text>“Financial exploitation” means the misappropriation of a resident’s assets or income, including:</text> <paragraph num="(a)"> <text>Spending the resident’s assets or income against the will of or without the consent of the resident or the resident agent;</text> </paragraph> <paragraph num="(b)"> <text>Spending the resident’s assets or income for the use and benefit of a person other than the resident, if the resident or resident agent has not consented to the expenditure; or</text> </paragraph> <paragraph num="(c)"> <text>The resident agent’s misappropriation of the resident funds.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Frequent” means occurring or appearing quite often or at close intervals, but not continuously.</text> </paragraph> <paragraph num="(35)"> <text>“Health care practitioner” means a physician, a certified nurse practitioner, or a physician assistant who provides health care services and is licensed under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(36)"> <text>“Health condition” means the status of a resident’s physical, mental, and psychosocial well-being.</text> </paragraph> <paragraph num="(37)"> <text>“Home health services” means those services provided as defined in Health-General Article, §§19-401—19-410 or §§19-4A-01—19-4A-10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(38)"> <text>“Household member” means an individual living in an assisted living program who is not a resident or staff member.</text> </paragraph> <paragraph num="(39)"> <text>“Incident” means:</text> <paragraph num="(a)"> <text>The death of a resident from other than natural causes;</text> </paragraph> <paragraph num="(b)"> <text>The disappearance or elopement of a resident;</text> </paragraph> <paragraph num="(c)"> <text>An assault on a resident resulting in injury;</text> </paragraph> <paragraph num="(d)"> <text>An injury to a resident which may require treatment by a health care practitioner, or an event such as a fall which could subsequently require treatment;</text> </paragraph> <paragraph num="(e)"> <text>Abuse, neglect, or financial exploitation of a resident;</text> </paragraph> <paragraph num="(f)"> <text>An error or omission in medication or treatment which may result in harm to the resident;</text> </paragraph> <paragraph num="(g)"> <text>An emergency situation or natural disaster; or</text> </paragraph> <paragraph num="(h)"> <text>Any other event that results in death, permanent harm, or severe temporary harm.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>“Informal dispute resolution (IDR)” means an informal process that provides an assisted living program the opportunity to dispute one or more deficiencies cited in a written statement of deficiencies issued by the Department or the Department’s designee related to a recent survey.</text> </paragraph> <paragraph num="(41)"> <text>“Instrumental activities of daily living” means home management skills, such as shopping for food and personal items, preparing meals, or handling money.</text> </paragraph> <paragraph num="(42)"> <text>“Intensive” means highly concentrated.</text> </paragraph> <paragraph num="(43)"> <text>“Intermittent nursing care” means nursing care which is provided episodically, irregularly, or for a limited time period.</text> </paragraph> <paragraph num="(44)"> <text>Involuntary Seclusion.</text> <paragraph num="(a)"> <text>“Involuntary seclusion” means the separation of a resident from others or from the resident’s room or confinement to the resident’s room with or without roommates, against the resident’s will or the will of the resident representative.</text> </paragraph> <paragraph num="(b)"> <text>“Involuntary seclusion” does not mean separating a resident from other residents on a temporary and monitored basis.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Lavatory” means a basin used to maintain personal cleanliness that has hot and cold running water and sanitary drainage.</text> </paragraph> <paragraph num="(46)"> <text>“Law enforcement agency” means the Maryland State Police or a police agency of a county or municipal corporation.</text> </paragraph> <paragraph num="(47)"> <text>“License” means a document issued by the Secretary to operate an assisted living program in the State.</text> </paragraph> <paragraph num="(48)"> <text>“Licensed pharmacist” means an individual who is authorized to practice pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(49)"> <text>“Licensed physician” means an individual who is authorized to practice medicine under Health Occupation Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(50)"> <text>“Licensee” means the person to whom a license is issued.</text> </paragraph> <paragraph num="(51)"> <text>“Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control over the day-to-day operations of the assisted living program.</text> </paragraph> <paragraph num="(52)"> <text>“Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(53)"> <text>“Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(54)"> <text>Mental Abuse.</text> <paragraph num="(a)"> <text>“Mental abuse” means an intentional course of conduct resulting in or intended to produce emotional harm.</text> </paragraph> <paragraph num="(b)"> <text>“Mental abuse” does not include the performance of an accepted clinical or medical procedure.</text> </paragraph> </paragraph> <paragraph num="(55)"> <text>“Minimal” means the least amount required to produce the desired result.</text> </paragraph> <paragraph num="(56)"> <text>“Neglect” means depriving a resident of adequate food, clothing, shelter, supervision, essential medical treatment, or essential rehabilitative therapy.</text> </paragraph> <paragraph num="(57)"> <text>Nursing Overview.</text> <paragraph num="(a)"> <text>“Nursing overview” means a process by which a registered nurse assures that the health and psychosocial needs of the resident are met.</text> </paragraph> <paragraph num="(b)"> <text>“Nursing overview” includes:</text> <paragraph num="(i)"> <text>Observation;</text> </paragraph> <paragraph num="(ii)"> <text>Assessment;</text> </paragraph> <paragraph num="(iii)"> <text>Staff education; and</text> </paragraph> <paragraph num="(iv)"> <text>The development, implementation, and evaluation of a resident’s service plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(58)"> <text>“Occasional” means occurring from time to time, on an infrequent or irregular basis, with no particular pattern.</text> </paragraph> <paragraph num="(59)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(60)"> <text>“Ongoing” means continuing over an extended period of time.</text> </paragraph> <paragraph num="(61)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(62)"> <text>“Personal representative” means an individual appointed by the court with the duties and authority to settle and distribute the estate of the decedent consistent with Estates and Trusts Article, §7-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(63)"> <text>“Physical abuse” means the sustaining of any physical injury or pain to a resident as a result of cruel or inhumane treatment, or as a result of a malicious act by any individual.</text> </paragraph> <paragraph num="(64)"> <text>Physical Restraint.</text> <paragraph num="(a)"> <text>“Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body, or limb movement that cannot be readily and easily removed by the resident.</text> </paragraph> <paragraph num="(b)"> <text>“Physical restraint” does not mean a protective device as defined in this regulation.</text> </paragraph> </paragraph> <paragraph num="(65)"> <text>“Plan of correction” means a written response from the assisted living program that addresses how each deficiency cited as a result of a survey by the Department or the Department’s designee will be corrected.</text> </paragraph> <paragraph num="(66)"> <text>“Protective device” means any device or equipment, except bedside rails:</text> <paragraph num="(a)"> <text>That:</text> <paragraph num="(i)"> <text>Shields a resident from self-injury;</text> </paragraph> <paragraph num="(ii)"> <text>Prevents a resident from aggravating an existing physical problem; or</text> </paragraph> <paragraph num="(iii)"> <text>Prevents a resident from precipitating a potential physical problem;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That may limit, but does not eliminate, the movement of the resident’s head, body, or limbs; and</text> </paragraph> <paragraph num="(c)"> <text>That is prescribed by a health care practitioner.</text> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Quality assurance” means a system for maintaining professionally acceptable standards of care by:</text> <paragraph num="(a)"> <text>Identifying opportunities to improve;</text> </paragraph> <paragraph num="(b)"> <text>Studying problems, if any, and their root causes; and</text> </paragraph> <paragraph num="(c)"> <text>Implementing and monitoring interventions to ensure the intended improvement is achieved and sustained.</text> </paragraph> </paragraph> <paragraph num="(68)"> <text>“Relief personnel” means qualified individuals who have been hired to substitute for certain staff members:</text> <paragraph num="(a)"> <text>In emergency situations; or</text> </paragraph> <paragraph num="(b)"> <text>When the assisted living manager or other staff is absent from the assisted living program for extended hours.</text> </paragraph> </paragraph> <paragraph num="(69)"> <text>“Resident” means an individual 18 years old or older who requires assisted living services.</text> </paragraph> <paragraph num="(70)"> <text>“Resident agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant’s or resident’s share of the costs or other charges for assisted living services.</text> </paragraph> <paragraph num="(71)"> <text>“Resident agreement” means a document signed by both the resident or the resident agent and the assisted living manager, or designee, stating the terms that the parties agree to, including, at a minimum, the provisions set forth in Regulations .26 and .27 of this chapter.</text> </paragraph> <paragraph num="(72)"> <text>“Resident Assessment Tool” means Maryland’s Assisted Living Resident Assessment and Level of Care Scoring Tool that is:</text> <paragraph num="(a)"> <text>Developed by the OHCQ with input from assisted living program staff; and</text> </paragraph> <paragraph num="(b)"> <text>Used by assisted living programs to assess the current health, physical, and psychosocial status of prospective and current residents.</text> </paragraph> </paragraph> <paragraph num="(73)"> <text>Resident Representative.</text> <paragraph num="(a)"> <text>“Resident representative” means a person referenced in Regulation .35 of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Resident representative” does not include an assisted living program owner or employee that has been designated as a representative payee for a resident.</text> </paragraph> </paragraph> <paragraph num="(74)"> <text>Restraint.</text> <paragraph num="(a)"> <text>“Restraint” means any chemical restraint or physical restraint as defined in §B(15) and (64) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>“Restraint” does not include a protective device.</text> </paragraph> </paragraph> <paragraph num="(75)"> <text>“Sanction” means a disciplinary penalty imposed for a violation of statutes or regulations relating to the operation of an assisted living program, including, but not limited to, those penalties referenced in Regulations .58, .59, .61, .63, and .64 of this chapter.</text> </paragraph> <paragraph num="(76)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee.</text> </paragraph> <paragraph num="(77)"> <text>“Self-administration of medication” means a resident having the cognitive and physical ability to take medication as prescribed by an authorized prescriber:</text> <paragraph num="(a)"> <text>At the correct time;</text> </paragraph> <paragraph num="(b)"> <text>By the correct route; and</text> </paragraph> <paragraph num="(c)"> <text>In the correct dosage.</text> </paragraph> </paragraph> <paragraph num="(78)"> <text>“Service plan” means a written plan developed by an assisted living program in conjunction with the resident and the resident representative, if appropriate, which identifies, among other things, services that the assisted living program will provide to the resident based upon the resident’s needs as determined by the Resident Assessment Tool.</text> </paragraph> <paragraph num="(79)"> <text>“Sexual abuse” means a crime listed in Criminal Law Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(80)"> <text>“Short-term residential care” means a stay, either continuous or intermittent, in an assisted living program of not more than 30 consecutive days from the date of initial admission, which cannot exceed 180 days per year.</text> </paragraph> <paragraph num="(81)"> <text>Significant Change of Condition.</text> <paragraph num="(a)"> <text>“Significant change of condition” means a shift in a resident’s health, functional, cognitive, behavioral, or psychosocial conditions that either causes an improvement or deterioration in a resident’s condition as described in the Resident Assessment Tool.</text> </paragraph> <paragraph num="(b)"> <text>“Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior, or an acute short-term illness, such as a cold, unless these fluctuations continue to recur.</text> </paragraph> </paragraph> <paragraph num="(82)"> <text>“Staff” means supervisors, assistants, aides, or other employees, including independent contractors retained by an assisted living program, to provide the care and services required by this chapter.</text> </paragraph> <paragraph num="(83)"> <text>“Standard precautions” means a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood, body fluids, non-intact skin (including rashes), and mucous membranes.</text> </paragraph> <paragraph num="(84)"> <text>“Substantial” means considerable in importance, degree, amount, frequency, or extent.</text> </paragraph> <paragraph num="(85)"> <text>“Trauma-informed approach” means an approach to care delivery that:</text> <paragraph num="(a)"> <text>Recognizes the widespread impact and signs and symptoms of trauma in residents; and</text> </paragraph> <paragraph num="(b)"> <text>Incorporates knowledge about trauma into care plans, policies, procedures, and practices to avoid re-traumatization.</text> </paragraph> </paragraph> <paragraph num="(86)"> <text>“Trauma-informed care” means an approach to delivering care that involves understanding, recognizing and responding to the effects of all types of trauma.</text> </paragraph> <paragraph num="(87)"> <text>“Treatment” means medical or psychological management to cure, slow the progression of, maintain, or improve a disease or condition.</text> </paragraph> <paragraph num="(88)"> <text>“Unclaimed deceased resident” means a resident of an assisted living program:</text> <paragraph num="(a)"> <text>Who has not prearranged and prepaid for the disposal of the resident’s body; or</text> </paragraph> <paragraph num="(b)"> <text>For whom no individual has claimed the body and assumed funeral or burial responsibility.</text> </paragraph> </paragraph> <paragraph num="(89)"> <text>“Verbal abuse” means the use of any oral or gestured language that includes disparaging or derogatory terms, which is directed to a resident, or within a resident’s hearing distance, regardless of the resident’s age, ability to comprehend, or disability.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>Centers for Disease Control and Prevention (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 2005, which is incorporated by reference in COMAR 10.07.02.02;</text> </paragraph> <paragraph num="B."> <text>National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06; and</text> </paragraph> <paragraph num="C."> <text>The State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Required."> <paragraph num="A."> <text>A person may not operate an assisted living program in the State without obtaining a license from the Secretary and complying with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Providing housing under a landlord-tenant arrangement does not, in and of itself, exclude a person from the licensure requirements of this chapter.</text> </paragraph> <paragraph num="C."> <text>Separate licenses are required for assisted living programs that are maintained on the same or separate premises, even though the programs are operated by the same person.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall issue a license for a specified number of beds and a specified level of care.</text> </paragraph> <paragraph num="E."> <text>An assisted living program may not provide services beyond its licensed authority by:</text> <paragraph num="(1)"> <text>Providing care to more residents than the total number of licensed beds; or</text> </paragraph> <paragraph num="(2)"> <text>Providing care beyond the specified level of care without first obtaining written approval of a resident-specific waiver request from the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The number of residents, as stated in §E of this regulation, includes:</text> <paragraph num="(1)"> <text>Residents in the facility;</text> </paragraph> <paragraph num="(2)"> <text>Individuals admitted to the assisted living program for short-term residential care;</text> </paragraph> <paragraph num="(3)"> <text>Family members who are cared for by assisted living program staff; and</text> </paragraph> <paragraph num="(4)"> <text>Individuals who are transitioning to the assisted living program.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An assisted living program shall conspicuously post its license in a common-use area at the facility.</text> </paragraph> <paragraph num="H."> <text>A person who falsifies or alters an assisted living program license shall be subject to referral for a criminal prosecution and imposition of civil fines, as specified in Regulations .57—.65 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Levels of Care."> <paragraph num="A."> <text>An assisted living program may provide:</text> <paragraph num="(1)"> <text>The level of care for which the assisted living program has been approved; and</text> </paragraph> <paragraph num="(2)"> <text>Any lower level of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At the time of initial licensure, an applicant shall:</text> <paragraph num="(1)"> <text>Request approval to provide services at one of the three levels of care set forth in §G of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate that the assisted living program has the capacity to provide the level of care requested either directly or through the coordination of community services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If, at any time, an assisted living program wants to provide a higher level of care than that for which it is licensed, the assisted living program shall request authority from the Department to change its licensed level of care.</text> </paragraph> <paragraph num="D."> <text>The Department shall determine if an applicant or the assisted living program has the capacity to provide and ensure the requested level of care.</text> </paragraph> <paragraph num="E."> <text>The Department may approve or deny the request.</text> </paragraph> <paragraph num="F."> <text>If an applicant or an assisted living program is aggrieved by the Department’s decision, the applicant or the assisted living program may appeal by filing a request for a hearing consistent with Regulation .65 of this chapter.</text> </paragraph> <paragraph num="G."> <text>Levels of Care.</text> <paragraph num="(1)"> <text>The applicant or assisted living program shall:</text> <paragraph num="(a)"> <text>Request one of the levels of care listed below; and</text> </paragraph> <paragraph num="(b)"> <text>Have sufficient staff and the abilities necessary to provide the level of care selected.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Level 1: Low Level of Care.</text> <paragraph num="(a)"> <text>Health and Wellness. Staff shall have the ability to:</text> <paragraph num="(i)"> <text>Recognize the causes and risks associated with a resident’s current health condition once these factors are identified by a health care practitioner; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide occasional assistance in accessing and coordinating health services and interventions.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Functional Condition. Staff shall have the ability to provide occasional supervision, assistance, support, setup, or reminders with two or more activities of daily living.</text> </paragraph> <paragraph num="(c)"> <text>Medication and Treatment. Staff shall have the ability to assist a resident with taking medication or to coordinate access to necessary medication and treatment.</text> </paragraph> <paragraph num="(d)"> <text>Behavioral Condition. Staff shall have the ability to monitor and provide uncomplicated intervention to manage occasional behaviors that are likely to disrupt or harm the resident or others.</text> </paragraph> <paragraph num="(e)"> <text>Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage occasional psychological or psychiatric episodes or fluctuations that require uncomplicated intervention or support.</text> </paragraph> <paragraph num="(f)"> <text>Social and Recreational Interests. Staff shall have the ability to provide occasional assistance in accessing social and recreational services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Level 2: Moderate Level of Care.</text> <paragraph num="(a)"> <text>Health and Wellness. Staff shall have the ability to:</text> <paragraph num="(i)"> <text>Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the resident’s condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide or ensure access to necessary health services and interventions.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Functional Condition. Staff shall have the ability to provide or ensure:</text> <paragraph num="(i)"> <text>Substantial support with two or more activities of daily living; or</text> </paragraph> <paragraph num="(ii)"> <text>Minimal support with any number of activities of daily living.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Medication and Treatment. Staff shall have the ability to:</text> <paragraph num="(i)"> <text>Provide or ensure assistance with taking medication; or</text> </paragraph> <paragraph num="(ii)"> <text>Administer necessary medication and treatment, including monitoring the effects of the medication and treatment.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Behavioral Condition. Staff shall have the ability to monitor and provide or ensure intervention to manage frequent behaviors which are likely to disrupt or harm the resident or others.</text> </paragraph> <paragraph num="(e)"> <text>Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage frequent psychological or psychiatric episodes that may require limited skilled interpretation, or prompt intervention or support.</text> </paragraph> <paragraph num="(f)"> <text>Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing assistance in accessing social and recreational services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Level 3: High Level of Care.</text> <paragraph num="(a)"> <text>Health and Wellness. Staff shall have the ability to:</text> <paragraph num="(i)"> <text>Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the residents’ condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide or ensure ongoing access to and coordination of comprehensive health services and interventions, including nursing overview.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Functional Condition. Staff shall have the ability to provide or ensure comprehensive support as frequently as needed to compensate for any number of activities of daily living deficits.</text> </paragraph> <paragraph num="(c)"> <text>Medication and Treatment. Staff shall have the ability to:</text> <paragraph num="(i)"> <text>Provide or ensure assistance with taking medication; and</text> </paragraph> <paragraph num="(ii)"> <text>Administer necessary medication and treatment, including monitoring or arranging for monitoring of the effects of complex medication and treatment regimens.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Behavioral Condition. Staff shall have the ability to monitor and provide or ensure ongoing therapeutic intervention or intensive supervision to manage chronic behaviors which are likely to disrupt or harm the resident or others.</text> </paragraph> <paragraph num="(e)"> <text>Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage a variety of psychological or psychiatric episodes involving active symptoms, condition changes, or significant risks that may require skilled interpretation or immediate interventions.</text> </paragraph> <paragraph num="(f)"> <text>Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing access to comprehensive social and recreational services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Restrictions."> <paragraph num="A."> <text>Restricted Nomenclature. An assisted living program licensed under this chapter may not use in its title or advertising the words “hospital”, “sanitarium”, “nursing”, “convalescent”, “rehabilitative”, “sub-acute”, or “hospice”.</text> </paragraph> <paragraph num="B."> <text>Advertising an Assisted Living Program.</text> <paragraph num="(1)"> <text>Prohibited Terms. A person operating an assisted living program may not use the term “assisted living” in its advertising without being licensed as an assisted living program by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Misleading or False Advertising.</text> <paragraph num="(a)"> <text>A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this chapter.</text> </paragraph> <paragraph num="(b)"> <text>A person may not advertise an assisted living program in a misleading or fraudulent manner.</text> </paragraph> <paragraph num="(c)"> <text>The Department shall report misleading or false advertising to the Office of the Attorney General, Division of Consumer Protection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Drop-In or Day Services.</text> <paragraph num="(1)"> <text>An assisted living program may not provide day, partial, or hourly adult day care services without appropriate adult medical day care licensure.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has applied for admission or who has been admitted to the assisted living program may, for a reasonable period of time not to exceed 30 calendar days, transition to the program in increments of partial days before becoming a resident.</text> </paragraph> <paragraph num="(3)"> <text>All regulations of this chapter apply to services and care provided during this transition period.</text> </paragraph> <paragraph num="(4)"> <text>An individual who has applied for admission or who has been admitted to the licensee who is transitioning to the assisted living program is counted as a resident.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Dual Licensure. An assisted living program dually licensed as an adult medical day care program or any other licensed program shall meet all requirements for both programs.</text> </paragraph> <paragraph num="E."> <text>A person who falsifies or alters an assisted living license shall be subject to referral for criminal prosecution and imposition of civil fines.</text> </paragraph> <paragraph num="F."> <text>Disclosure of Ownership. An assisted living owner shall disclose any ownership of an adult medical day care center to an assisted living resident prior to referring the resident to the center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensing Procedure."> <paragraph num="A."> <text>Application for License.</text> <paragraph num="(1)"> <text>To obtain and maintain a license, an applicant shall meet all of the requirements of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>Other applicable federal, State, and local laws and regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Health-General Article, §19-311, Annotated Code of Maryland, if the program provides services to 17 or more residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant shall submit:</text> <paragraph num="(a)"> <text>An application on a written or electronic form developed by the Department;</text> </paragraph> <paragraph num="(b)"> <text>The completed Uniform Disclosure Statement on a form developed by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>All other reasonable documents as required by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At a minimum, the applicant shall provide:</text> <paragraph num="(a)"> <text>Verification that the applicant or corporate representative is 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties;</text> </paragraph> <paragraph num="(c)"> <text>Identification of any individual or corporate owner of 25 percent or more interest in the assisted living program;</text> </paragraph> <paragraph num="(d)"> <text>Documentation of any conviction and current background check or criminal history records check of the owner, the applicant, the assisted living manager, the alternate assisted living manager, other staff, and any household member;</text> </paragraph> <paragraph num="(e)"> <text>Ownership information as specified on an addendum to the application;</text> </paragraph> <paragraph num="(f)"> <text>Verification that the facility is owned, leased, or otherwise under the control of the applicant;</text> </paragraph> <paragraph num="(g)"> <text>The level of care to be provided by the assisted living program, its location, and the name of the proposed assisted living manager;</text> </paragraph> <paragraph num="(h)"> <text>Documentation of zoning approval, if zoning approval is required by the local jurisdiction in which the assisted living program will be located; and</text> </paragraph> <paragraph num="(i)"> <text>Where applicable, approvals from the local health department, local or State fire authority, and local area agency on aging.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Requirements for Initial Licensure. The Secretary shall require an applicant for initial licensure to submit:</text> <paragraph num="(1)"> <text>Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including the prior or current operation by the applicant of a health care facility or similar health care program;</text> </paragraph> <paragraph num="(2)"> <text>Information demonstrating financial or administrative ability to operate an assisted living program in compliance with this chapter, which shall include a business plan and 1-year operating budget;</text> </paragraph> <paragraph num="(3)"> <text>Policies and procedures to be implemented as designated in the application for licensure; and</text> </paragraph> <paragraph num="(4)"> <text>Other reasonably relevant information, if required by law or local jurisdiction, such as:</text> <paragraph num="(a)"> <text>Verification of Workers’ Compensation insurance;</text> </paragraph> <paragraph num="(b)"> <text>Facility plan review documentation;</text> </paragraph> <paragraph num="(c)"> <text>Food service permit; and</text> </paragraph> <paragraph num="(d)"> <text>Rental license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>License Suspension or Revocation.</text> <paragraph num="(1)"> <text>The owner, assisted living manager, alternate assisted living manager, or board member of an assisted living program that has had its license suspended or revoked by the Department may not own, operate, lease, or manage another assisted living program for 10 years from the date the license was suspended or revoked without good cause shown.</text> </paragraph> <paragraph num="(2)"> <text>After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an assisted living program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Sanctions and Uncorrected Deficiencies.</text> <paragraph num="(1)"> <text>If an owner, assisted living manager, or alternate assisted living manager of an assisted living program operates, leases, or manages an assisted living program that has had sanctions imposed or deficiencies cited within the past 3 years and has not corrected the deficiencies which present a risk to the health or safety of residents for a currently licensed assisted living program, that owner, assisted living manager, or alternate assisted living manager may not apply to open an additional assisted living program until those deficiencies have been corrected as approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Department may not approve a license application for an assisted living program if the owner, assisted living manager, or alternate assisted living manager operates, leases, or manages a licensed assisted living program that has uncorrected deficiencies.</text> </paragraph> <paragraph num="(3)"> <text>In making a determination about a pending assisted living program license application, the Department may consider any sanctions or uncorrected deficiencies that were imposed before or after the application submission which present a risk to the health or safety of residents for a currently licensed assisted living program that is operated, leased, or managed by an owner, assisted living manager, or alternate assisted living manager in the pending license application.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Violations and Criminal Convictions.</text> <paragraph num="(1)"> <text>The Department reserves the right to deny licensure to an applicant based on the owner’s, assisted living manager’s, or alternate assisted living manager’s prior:</text> <paragraph num="(a)"> <text>History of violations of assisted living regulations;</text> </paragraph> <paragraph num="(b)"> <text>Criminal history that the Department determines may be potentially harmful to residents;</text> </paragraph> <paragraph num="(c)"> <text>Convictions as described in 42 U.S.C. §1320a–7(a) or Criminal Law Article, §14-101, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>History of final actions of a Health Occupations Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In making a determination about a license application, the Department shall consider the following factors related to a criminal conviction:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime; and</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In making a determination about a license application, the Department shall consider the following factors related to a violation of assisted living regulations:</text> <paragraph num="(a)"> <text>The circumstances surrounding the violation;</text> </paragraph> <paragraph num="(b)"> <text>The length of time since the violation occurred;</text> </paragraph> <paragraph num="(c)"> <text>The scope of the violation;</text> </paragraph> <paragraph num="(d)"> <text>The severity of the violation; and</text> </paragraph> <paragraph num="(e)"> <text>The implementation of a plan of correction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department shall consider other evidence that demonstrates whether the applicant poses a threat to the health or safety of residents in an assisted living program.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Determination of License Application.</text> <paragraph num="(1)"> <text>Based on information provided to the Department by the applicant and the Department’s own investigation, the Secretary shall:</text> <paragraph num="(a)"> <text>Approve the application unconditionally;</text> </paragraph> <paragraph num="(b)"> <text>Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or</text> </paragraph> <paragraph num="(c)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may not require use of a management firm for a period in excess of 24 months.</text> </paragraph> <paragraph num="(3)"> <text>A person may not:</text> <paragraph num="(a)"> <text>Operate an assisted living program until a provisional license or license has been issued; or</text> </paragraph> <paragraph num="(b)"> <text>Operate multiple sites until each site has been inspected and approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A person aggrieved by a decision of the Secretary under this section to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provisional Licenses for Less than 1 Year. The Department may issue a provisional license if:</text> <paragraph num="(1)"> <text>An assisted living program is not in full compliance with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The Department determines that the noncompliance does not constitute a safety or health hazard; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant or assisted living program has submitted a plan of correction acceptable to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>License Application Administratively Closed.</text> <paragraph num="(1)"> <text>An application is not complete until the Department has received the completed license application and all required documents.</text> </paragraph> <paragraph num="(2)"> <text>After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application.</text> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is administratively closed may reapply for a license by submitting a new application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Changes in an Assisted Living Program that Affect the Operating License."> <paragraph num="A."> <text>General Information Related to Licensure.</text> <paragraph num="(1)"> <text>A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application.</text> </paragraph> <paragraph num="(2)"> <text>A license is valid only in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer.</text> </paragraph> <paragraph num="(3)"> <text>A license is valid only for the premises for which it was originally issued.</text> </paragraph> <paragraph num="(4)"> <text>A licensee shall forward to the Department a copy of any report or citation of a violation of any applicable building codes, sanitary codes, fire safety codes, or other regulations affecting the health, safety, or welfare of residents within 7 calendar days of receipt of the report or citation. An assisted living program’s failure to notify the Department may result in the imposition of a sanction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Increase in Licensed Beds.</text> <paragraph num="(1)"> <text>An assisted living program may not provide assisted living services to more residents than the number of beds approved in writing by the Department.</text> </paragraph> <paragraph num="(2)"> <text>To request an increase in the number of beds, a licensed assisted living program shall:</text> <paragraph num="(a)"> <text>Submit the request for an increase in licensed beds on the form developed by and in the manner established by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Attach the required documents, including, at a minimum, proof of compliance with all local requirements for fire safety, use and occupancy, and zoning permits.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If approved, the Department shall issue a new license to the assisted living program that includes the approved number of beds.</text> </paragraph> <paragraph num="(4)"> <text>Upon receipt of a new license, all use of the previously issued assisted living program license shall cease.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Increase in Level of Care.</text> <paragraph num="(1)"> <text>An assisted living program may not provide a higher level of care for residents than is approved by the Department unless a specific resident has a waiver to receive a higher level of care.</text> </paragraph> <paragraph num="(2)"> <text>To request an increase in the level of care, an assisted living program shall:</text> <paragraph num="(a)"> <text>Submit the request for an increase in the level of care on the form developed by and in the manner established by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Attach supporting documentation, including any changes in staffing, training, or policies and procedures.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If approved, the Department shall issue a new license to the assisted living program that includes the approved level of care.</text> </paragraph> <paragraph num="(4)"> <text>Upon receipt of a new license, all use of the previously issued assisted living program license shall cease.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Name Change.</text> <paragraph num="(1)"> <text>An assisted living program shall have a revised license from the Department to change its name or the name under which the program is doing business.</text> </paragraph> <paragraph num="(2)"> <text>To request a name change, an assisted living program shall:</text> <paragraph num="(a)"> <text>Submit the request for a name change on the form developed by and in the manner established by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Attach the required attachments, including a letter of good standing from the Maryland State Department of Assessments and Taxation (SDAT) Business Express.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon processing, the Department shall issue a new license to the assisted living program that includes the new name of the licensee.</text> </paragraph> <paragraph num="(4)"> <text>Upon receipt of a new license, all use of the previously issued assisted living program license shall cease.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Change of Location.</text> <paragraph num="(1)"> <text>Prior to operating an assisted living program at a new location, the applicant shall have an assisted living program license issued by the Department.</text> </paragraph> <paragraph num="(2)"> <text>To request an assisted living program license for a new location, an applicant shall:</text> <paragraph num="(a)"> <text>Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Submit all required attachments.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An assisted living program shall notify the Department in writing of a relocation:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the effective date if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An assisted living program shall notify residents and resident representatives in writing of a relocation:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the effective date if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If approved, the Department shall issue a license to the assisted living program at the new location.</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of a new license, all use of the previously issued assisted living program license shall cease.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Change of Ownership — Sale, Transfer, or Lease of a Facility.</text> <paragraph num="(1)"> <text>If a sale, transfer, or lease of a facility causes a change in the person or persons who control or operate the assisted living program, the assisted living program shall be considered a new program and the new owner shall apply for a license and conform to all regulations applicable at the time of transfer of operations.</text> </paragraph> <paragraph num="(2)"> <text>The transfer of any stock which results in a change of the person or persons who control the program or the transfer of any stock in excess of 25 percent of the outstanding stock, constitutes a sale.</text> </paragraph> <paragraph num="(3)"> <text>For the purposes of Life Safety Code enforcement, the program is considered an existing facility if it has been in continuous use as an assisted living program.</text> </paragraph> <paragraph num="(4)"> <text>An assisted living program shall notify the Department in writing of a change of ownership, sale, transfer, or lease of a facility:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the effective date if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An assisted living program shall notify residents and resident representatives in writing of a change of ownership, sale, transfer, or lease of a facility:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the effective date if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If a change of ownership of the assisted living program is occurring, the new owner shall:</text> <paragraph num="(a)"> <text>Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Submit all required attachments.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If approved, the Department shall issue a license to the assisted living program.</text> </paragraph> <paragraph num="(8)"> <text>Upon receipt of a new license, all use of the previously issued assisted living licensee shall immediately cease.</text> </paragraph> <paragraph num="(9)"> <text>A licensee named in the original license shall remain responsible for the operation of the assisted living program until a new license is issued to the new owner, and the current licensee shall remain responsible for correction of all outstanding deficiencies or impending sanctions until a new license is issued to the new owner.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Voluntary Closure.</text> <paragraph num="(1)"> <text>An assisted living program shall notify the Department of any intention to voluntarily close:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the closure if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall include the following information in the notice to the Department:</text> <paragraph num="(a)"> <text>The method for informing residents and resident representatives of its intent to close, change ownership, change location, or sell its assisted living program; and</text> </paragraph> <paragraph num="(b)"> <text>The actions the assisted living program will take to assist residents in securing comparable housing and assistance, if necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An assisted living program shall notify residents and resident representatives of a voluntary closure, in writing:</text> <paragraph num="(a)"> <text>Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or</text> </paragraph> <paragraph num="(b)"> <text>Within 75 calendar days in advance of the closure if licensed for 50 or more beds.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The assisted living program shall provide at least weekly updates to the OHCQ, including:</text> <paragraph num="(a)"> <text>Number of residents remaining in the facility;</text> </paragraph> <paragraph num="(b)"> <text>Number of residents with plans for relocation; and</text> </paragraph> <paragraph num="(c)"> <text>Number of residents with no plans for relocation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In addition to the notice to the Department required by §B of this regulation, after a program closes, the assisted living program shall:</text> <paragraph num="(a)"> <text>Notify the Department of the date of closure and the place of relocation of each resident; and</text> </paragraph> <paragraph num="(b)"> <text>Cease all use of the previously issued assisted living program license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Voiding of License.</text> <paragraph num="(1)"> <text>Maryland State Department of Assessments and Taxation (SDAT).</text> <paragraph num="(a)"> <text>A licensed assisted living program shall remain in good standing with (SDAT).</text> </paragraph> <paragraph num="(b)"> <text>If the assisted living program fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the assisted living program’s license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ceases the Provision of Services.</text> <paragraph num="(a)"> <text>A license is void if the assisted living program ceases to provide services to residents for a period of 180 consecutive days.</text> </paragraph> <paragraph num="(b)"> <text>The owner shall immediately cease all use of the previously issued assisted living program license when the license is voided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>Unless the Department agrees to accept the surrender of a license, an assisted living program may not surrender a license to operate an assisted living program nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the licensee.</text> </paragraph> <paragraph num="(2)"> <text>The Department may set conditions on its agreement with the licensee under investigation or against which charges are pending to accept surrender of the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Licensure Standards Waiver."> <paragraph num="A."> <text>The Department may grant an assisted living program a waiver from the licensure requirements of this chapter with or without conditions.</text> </paragraph> <paragraph num="B."> <text>The Department may not, however, grant a waiver from the requirements of Regulation .23A of this chapter. If, however, two individuals having a long-term or otherwise significant relationship wish to be admitted to a program in order to reside in the program together, and one of the individuals requires care as defined in Regulation .23A of this chapter, the Department may grant a waiver consistent with the process established in Regulation .24 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Application for Licensure Standards Waiver.</text> <paragraph num="(1)"> <text>An assisted living program shall submit a request for a waiver under this regulation on a form developed and in the manner established by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The requestor shall provide in writing the:</text> <paragraph num="(a)"> <text>Regulation from which a waiver is sought;</text> </paragraph> <paragraph num="(b)"> <text>Reason the assisted living program is unable to comply with the regulation;</text> </paragraph> <paragraph num="(c)"> <text>Reason that compliance with the regulation will impose a substantial hardship; and</text> </paragraph> <paragraph num="(d)"> <text>Reason that a waiver will not adversely affect residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application, and may:</text> <paragraph num="(1)"> <text>Inspect the assisted living program;</text> </paragraph> <paragraph num="(2)"> <text>Confer with the assisted living manager or designee; or</text> </paragraph> <paragraph num="(3)"> <text>Discuss the request with residents or their representatives to determine whether they believe a waiver is in the residents’ best interest.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Grant or Denial of Licensure Standards Waiver.</text> <paragraph num="(1)"> <text>The Department may grant a waiver request if it determines that:</text> <paragraph num="(a)"> <text>Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and</text> </paragraph> <paragraph num="(b)"> <text>A waiver will not adversely affect residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department determines that the conditions of §E(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Written Decision.</text> <paragraph num="(1)"> <text>The Department shall issue and mail to the applicant a final written decision on a waiver request submitted under §A of this regulation within 45 calendar days from receipt of the request and all appropriate supporting information.</text> </paragraph> <paragraph num="(2)"> <text>If the Department grants the waiver, the written decision shall include the waiver’s duration and any conditions imposed by the Department.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If an assisted living program violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the assisted living program will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Uniform Disclosure Statement."> <paragraph num="A."> <text>When an assisted living program changes the services reported on its Uniform Disclosure Statement filed with the Department under Regulation .07A(2)(b) of this chapter, the program shall file an amended Uniform Disclosure Statement with the Department within 30 calendar days of the change in services.</text> </paragraph> <paragraph num="B."> <text>If an individual requests a copy of an assisted living program’s Uniform Disclosure Statement, the assisted living program shall provide a copy of the Uniform Disclosure Statement on a form provided by the Department without cost to the individual making the request.</text> </paragraph> <paragraph num="C."> <text>An assisted living program shall provide a copy of the current Uniform Disclosure Statement to individuals as part of the program’s marketing materials.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Investigation by Department."> <paragraph num="A."> <text>Assisted Living Program to Be Open for Inspection.</text> <paragraph num="(1)"> <text>An assisted living program operated by a licensee, and any premises proposed to be operated as an assisted living program, shall be open at all times to announced or unannounced inspections by the Department and by any agency designated by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Any part of the facility, and any surrounding accessory buildings which may be entered by staff or residents, are considered part of the facility and are subject to inspection.</text> </paragraph> <paragraph num="(3)"> <text>An assisted living program and any premises proposed to be operated as an assisted living program may not deny access to the Department or any agency designated by the Department.</text> </paragraph> <paragraph num="(4)"> <text>At all times, the staff on duty at an assisted living program shall know how to contact the assisted living manager, alternate assisted living manager, delegating nurse, and alternate delegating nurse.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Records and Reports.</text> <paragraph num="(1)"> <text>Inspection.</text> <paragraph num="(a)"> <text>An assisted living program shall maintain records and reports.</text> </paragraph> <paragraph num="(b)"> <text>The records and reports may be paper or electronic documents.</text> </paragraph> <paragraph num="(c)"> <text>The records and reports shall be open to inspection by the Department or its designee.</text> </paragraph> <paragraph num="(d)"> <text>Except for the records permitted to be stored off-site, an assisted living program shall immediately, upon request, provide copies of records and reports, including medical records of residents, to the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintenance.</text> <paragraph num="(a)"> <text>The assisted living program shall maintain files on-site pertaining to:</text> <paragraph num="(i)"> <text>Current residents;</text> </paragraph> <paragraph num="(ii)"> <text>Residents who have been discharged within the last 6 months;</text> </paragraph> <paragraph num="(iii)"> <text>Staff; and</text> </paragraph> <paragraph num="(iv)"> <text>Quality assurance activities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The files listed in §B(2)(a) of this regulation shall be maintained on-site at the licensed assisted living program where residents receive assisted living services.</text> </paragraph> <paragraph num="(c)"> <text>All other records may be stored off-site but shall be available for inspection within 24 hours of a request from the Department or the Department’s designee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Posting of Documents. An assisted living program shall post the following documents in a conspicuous place that is visible to residents, potential residents, and other interested parties:</text> <paragraph num="(1)"> <text>All of the following:</text> <paragraph num="(a)"> <text>The notice of compliance or the statement of deficiencies and the plan of correction for the most recent annual licensure survey; and</text> </paragraph> <paragraph num="(b)"> <text>The notice of compliance or the statement of deficiencies and the plan of correction for all surveys conducted since the last annual licensure survey; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A notice describing where in the facility the items listed in §C(1) of this regulation may be found.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Notice of Deficiencies.</text> <paragraph num="(1)"> <text>If a survey identifies noncompliance with a requirement, the Secretary shall issue a notice:</text> <paragraph num="(a)"> <text>Citing each deficiency;</text> </paragraph> <paragraph num="(b)"> <text>Requiring the assisted living program to submit an acceptable plan of correction within 10 calendar days of receipt of the statement of deficiencies;</text> </paragraph> <paragraph num="(c)"> <text>Notifying the assisted living program of sanctions or that failure to correct the violation may result in sanctions; and</text> </paragraph> <paragraph num="(d)"> <text>Offering the assisted living program the opportunity for informal dispute resolution (IDR).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The plan of correction referred to in §D(1)(b) of this regulation shall include:</text> <paragraph num="(a)"> <text>How the assisted living program will correct each deficiency;</text> </paragraph> <paragraph num="(b)"> <text>The date by which each deficient practice will be corrected;</text> </paragraph> <paragraph num="(c)"> <text>How the assisted living program will prevent the deficient practice from recurring; and</text> </paragraph> <paragraph num="(d)"> <text>Who will be responsible for ensuring the deficiency will not reoccur.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failure to return an acceptable plan of correction within the allotted time frame may result in a sanction.</text> </paragraph> <paragraph num="(4)"> <text>A request for an IDR does not change the assisted living program’s requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Informal Dispute Resolution (IDR).</text> <paragraph num="(1)"> <text>An assisted living program may request an IDR to dispute one or more deficiencies in a statement of deficiencies.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall submit the request for an IDR to the Department within 10 calendar days of receiving the statement of deficiencies.</text> </paragraph> <paragraph num="(3)"> <text>The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by all evidence for the Department’s consideration.</text> </paragraph> <paragraph num="(4)"> <text>At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing.</text> </paragraph> <paragraph num="(5)"> <text>IDRs are informal in nature and are not attended by legal counsel representing the assisted living program or the Department.</text> </paragraph> <paragraph num="(6)"> <text>The IDR process may not delay the effective date of any enforcement action.</text> </paragraph> <paragraph num="(7)"> <text>In the event an assisted living program requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process.</text> </paragraph> <paragraph num="(8)"> <text>There is no appeal of the Department’s decision in an IDR.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Compliance Monitoring."> <paragraph num="A."> <text>The Department shall be responsible for monitoring and inspecting assisted living programs to determine compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Consistent with an interagency agreement, the Department may delegate certain aspects of its monitoring, inspection, or waiver responsibilities to the Department of Aging or a local health department.</text> </paragraph> <paragraph num="C."> <text>The Department or its designee may conduct announced or unannounced surveys.</text> </paragraph> <paragraph num="D."> <text>An assisted living program shall be surveyed on-site, at least annually. The Department may extend the time between surveys to up to 18 months if the assisted living program has:</text> <paragraph num="(1)"> <text>No outstanding plan of correction;</text> </paragraph> <paragraph num="(2)"> <text>No complaints or facility-reported incidents pending investigation;</text> </paragraph> <paragraph num="(3)"> <text>No settlement agreement in effect;</text> </paragraph> <paragraph num="(4)"> <text>No outstanding civil money penalty; and</text> </paragraph> <paragraph num="(5)"> <text>No sanctions in effect.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department, or those agencies delegated responsibility under this regulation, may inspect an assisted living program more frequently than annually if it is considered necessary to determine compliance with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Administration."> <paragraph num="A."> <text>Quality Assurance.</text> <paragraph num="(1)"> <text>The assisted living program manager or their designee shall develop and implement a quality assurance plan.</text> </paragraph> <paragraph num="(2)"> <text>Quality Assurance Plan.</text> <paragraph num="(a)"> <text>The quality assurance plan shall include an annual facility risk assessment for tuberculosis, in accordance with the CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005.</text> </paragraph> <paragraph num="(b)"> <text>The assisted living manager and the delegating nurse shall meet at least every 6 months to review the:</text> <paragraph num="(i)"> <text>Change in status of the assisted living program’s residents;</text> </paragraph> <paragraph num="(ii)"> <text>Service plan requirements; and</text> </paragraph> <paragraph num="(iii)"> <text>Written recommendations, findings, and outcomes of pharmacy reviews, as required by Regulation .31I of this chapter.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The assisted living manager shall document the proceedings of the meeting referred to in §A(2)(b) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Family Council.</text> <paragraph num="(1)"> <text>If assisted living program residents have a family council, the assisted living program shall make reasonable attempts to support and cooperate with the family council.</text> </paragraph> <paragraph num="(2)"> <text>The family council for an assisted living program may include the following members:</text> <paragraph num="(a)"> <text>Members of a current resident’s family;</text> </paragraph> <paragraph num="(b)"> <text>An individual appointed by a current resident who has the capacity to appoint an individual;</text> </paragraph> <paragraph num="(c)"> <text>A resident representative; or</text> </paragraph> <paragraph num="(d)"> <text>An individual appointed by a resident representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The assisted living program shall provide the family council the right to privacy for meetings and, if possible, the space to meet privately.</text> </paragraph> <paragraph num="(4)"> <text>Staff members may attend a meeting only if requested by the family council.</text> </paragraph> <paragraph num="(5)"> <text>The assisted living program shall consider the family council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect residents’ quality of life.</text> </paragraph> <paragraph num="(6)"> <text>The assisted living program shall respond in writing within 30 calendar days to the family council when it has received written requests or grievances from the council.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Resident Council.</text> <paragraph num="(1)"> <text>If an assisted living program has a resident council, the assisted living program shall make reasonable attempts to support and cooperate with the resident council.</text> </paragraph> <paragraph num="(2)"> <text>A resident council includes current residents of the assisted living program.</text> </paragraph> <paragraph num="(3)"> <text>The assisted living program shall provide the resident council the right to privacy for meetings and, if possible, the space to meet privately.</text> </paragraph> <paragraph num="(4)"> <text>Staff members may attend a meeting only if requested by the resident council.</text> </paragraph> <paragraph num="(5)"> <text>The assisted living program shall consider the council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect the residents’ quality of life.</text> </paragraph> <paragraph num="(6)"> <text>The assisted living program shall respond in writing within 30 calendar days to the resident council when it has received written requests or grievances from the council.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Staffing Plan."> <paragraph num="A."> <text>Following an analysis of the number of residents that the assisted living program intends to serve and the individual needs of each resident, the assisted living program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter.</text> </paragraph> <paragraph num="B."> <text>The assisted living program shall employ or contract with sufficient numbers of staff to comply with the:</text> <paragraph num="(1)"> <text>Requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Standards of care for the specific conditions of the residents the assisted living program serves; and</text> </paragraph> <paragraph num="(3)"> <text>All other applicable laws and regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Resident Care Needs.</text> <paragraph num="(1)"> <text>The resident’s care needs shall determine the:</text> <paragraph num="(a)"> <text>Need, amount, and frequency of nursing overview by the registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Need for on-site nursing services; and</text> </paragraph> <paragraph num="(c)"> <text>Need for awake overnight staff.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may approve a waiver of the requirement for awake overnight staff when the assisted living program has demonstrated to the Department its use of an effective electronic monitoring system.</text> </paragraph> <paragraph num="(3)"> <text>The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit.</text> </paragraph> <paragraph num="(4)"> <text>The assisted living program shall comply with applicable requirements of COMAR 10.27.09.</text> </paragraph> </paragraph> <paragraph num="D."> <text>On-Site Staff.</text> <paragraph num="(1)"> <text>The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents.</text> </paragraph> <paragraph num="(2)"> <text>When a resident is in the facility, a staff member shall be present.</text> </paragraph> <paragraph num="(3)"> <text>When a resident is expected to return to the assisted living program, a staff member shall be present.</text> </paragraph> <paragraph num="(4)"> <text>A staffing schedule shall:</text> <paragraph num="(a)"> <text>Be maintained on-site;</text> </paragraph> <paragraph num="(b)"> <text>Include the date, shift hours, and identifying name of all staff members scheduled to work; and</text> </paragraph> <paragraph num="(c)"> <text>Be kept on file for 18 months.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Awake Overnight Staff.</text> <paragraph num="(1)"> <text>An assisted living program shall provide awake overnight staff when a resident’s assessment using the Resident Assessment Tool indicates that awake overnight staff is required according to instructions on that tool.</text> </paragraph> <paragraph num="(2)"> <text>If a health care practitioner or assessing registered nurse, in the health care practitioner’s or registered nurse’s clinical judgment, does not believe that a resident requires awake overnight staff, the health care practitioner or assessing registered nurse shall document the reasons in the area provided in the Resident Assessment Tool.</text> </paragraph> <paragraph num="(3)"> <text>The assisted living program shall retain this documentation in the resident’s record.</text> </paragraph> <paragraph num="(4)"> <text>Awake overnight staff are required on an approved Alzheimer’s Special Care Unit.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Electronic Monitoring Systems.</text> <paragraph num="(1)"> <text>Upon the written recommendation of the resident’s health care practitioner, the assisted living program may apply to the Department for a waiver in accordance with Regulation .09 of this chapter to use an electronic monitoring system instead of awake overnight staff.</text> </paragraph> <paragraph num="(2)"> <text>If an electronic monitoring system is approved by the Department for the assisted living program to use, the licensee shall document the approval of the electronic monitoring system in the area provided on the Resident Assessment Tool.</text> </paragraph> <paragraph num="(3)"> <text>When a resident is assessed or reassessed using the Resident Assessment Tool, the health care practitioner shall review and document the:</text> <paragraph num="(a)"> <text>Need for awake overnight staff if the resident’s previous assessment or review of an assessment indicated awake overnight staff was not necessary at the time; and</text> </paragraph> <paragraph num="(b)"> <text>Continued appropriateness of a waiver to use an approved electronic monitoring system instead of awake overnight staff.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The assisted living program shall comply with applicable requirements of COMAR 10.27.09.</text> </paragraph> <paragraph num="(5)"> <text>The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit.</text> </paragraph> </paragraph> <paragraph num="G."> <text>On-Site Nursing Requirements.</text> <paragraph num="(1)"> <text>An assisted living program shall provide on-site nursing when a delegating nurse or health care practitioner, based upon the needs of a resident, issues a nursing or clinical order for that service.</text> </paragraph> <paragraph num="(2)"> <text>If an assisted living manager determines that a nursing or clinical order should not or cannot be implemented, the assisted living manager, delegating nurse, and resident’s health care practitioner shall discuss any alternatives that could safely address the resident’s needs.</text> </paragraph> <paragraph num="(3)"> <text>The assisted living manager shall document in the resident’s record this discussion and all individuals who participated in the discussion.</text> </paragraph> <paragraph num="(4)"> <text>If there are alternatives that could safely address the resident’s needs, the assisted living manager shall notify the resident and, if appropriate, the resident’s legal representative, the delegating nurse, and resident’s health care practitioner of the change to the order.</text> </paragraph> <paragraph num="(5)"> <text>The assisted living manager shall document in the resident’s record this change and the date of notification.</text> </paragraph> <paragraph num="(6)"> <text>If an assisted living manager fails to implement a nursing or clinical order without identifying and providing alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the OHCQ, and the resident or, if appropriate, the legal representative of the resident.</text> </paragraph> <paragraph num="(7)"> <text>Failure to implement a nursing or clinical order, without demonstrating why the order should not be followed or without identifying alternatives to care, may result in sanctions against the assisted living program and referral of a licensed or certified staff to the appropriate health occupations licensing board.</text> </paragraph> </paragraph> <paragraph num="H."> <text>On-site nursing personnel shall work in partnership with the delegating nurse and assisted living program staff to ensure:</text> <paragraph num="(1)"> <text>Adequate assessment of residents;</text> </paragraph> <paragraph num="(2)"> <text>Planning of medical services; and</text> </paragraph> <paragraph num="(3)"> <text>Oversight of nursing activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Assisted Living Manager."> <paragraph num="A."> <text>Qualifications.</text> <paragraph num="(1)"> <text>An individual shall be licensed as required by Health Occupations Article, §9-3A-01, Annotated Code of Maryland, before the individual may practice as an assisted living manager in Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living manager shall at a minimum:</text> <paragraph num="(a)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Possess a high school diploma, a high school equivalency diploma, or other appropriate education and have experience to conduct the responsibilities specified in §C of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>For level 3 licensed programs, have:</text> <paragraph num="(i)"> <text>A 4-year, college-level degree; or</text> </paragraph> <paragraph num="(ii)"> <text>2 years experience in a health care related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or</text> </paragraph> <paragraph num="(iii)"> <text>2 years experience in a health care related field and successful completion of an 80-hour assisted living manager training course approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities;</text> </paragraph> <paragraph num="(e)"> <text>Be immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination;</text> </paragraph> <paragraph num="(f)"> <text>Have no criminal convictions or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check, completed within 1 month before employment;</text> </paragraph> <paragraph num="(g)"> <text>Have sufficient skills, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living;</text> </paragraph> <paragraph num="(h)"> <text>Have verifiable knowledge in:</text> <paragraph num="(i)"> <text>The health and psychosocial needs of the population being served;</text> </paragraph> <paragraph num="(ii)"> <text>The resident assessment process;</text> </paragraph> <paragraph num="(iii)"> <text>Use of service plans;</text> </paragraph> <paragraph num="(iv)"> <text>Cuing, coaching, and monitoring residents who self-administer medications, with or without assistance;</text> </paragraph> <paragraph num="(v)"> <text>Providing assistance with ambulation, personal hygiene, dressing, toileting, and feeding; and</text> </paragraph> <paragraph num="(vi)"> <text>Resident rights;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Receive initial and annual training in:</text> <paragraph num="(i)"> <text>Fire and life safety;</text> </paragraph> <paragraph num="(ii)"> <text>Infection control, including standard precautions;</text> </paragraph> <paragraph num="(iii)"> <text>Emergency disaster plans; and</text> </paragraph> <paragraph num="(iv)"> <text>Basic food safety; and</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Receive initial certification and recertification every 2 years for:</text> <paragraph num="(i)"> <text>Basic first aid taught by a first aid instructor certified by a national organization; and</text> </paragraph> <paragraph num="(ii)"> <text>Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An assisted living manager who has completed the training and passed the examination set forth in Regulation .16 of this chapter shall be presumed to have met the knowledge requirements of §A(1)(g) and (h) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may determine that an individual is not sufficiently qualified to serve as an assisted living manager if that individual’s managerial or administrative experience, or education, is not sufficient to perform the responsibilities set forth in §C of this regulation for the residents the assisted living program intends to serve.</text> </paragraph> <paragraph num="C."> <text>Duties. The assisted living manager shall:</text> <paragraph num="(1)"> <text>Be on-site or available on call; and</text> </paragraph> <paragraph num="(2)"> <text>Have overall responsibility for:</text> <paragraph num="(a)"> <text>The management of the assisted living program, including recruiting, hiring, training, and supervising all staff, and ensuring that either a criminal history records check or a background check is conducted consistent with the requirements of Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The development and implementation of a staffing plan, which includes an orientation and ongoing training program for all staff, with specific training in the management, assessment, and programming for the resident with cognitive impairment as required by Health-General Article, §19-319.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>The development and implementation of all policies, programs, and services as required by this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Requiring all employees to perform hand hygiene with either soap and water or an alcohol-based hand sanitizer before and after each direct resident contact for which hand hygiene is indicated by acceptable practice;</text> </paragraph> <paragraph num="(e)"> <text>Providing or ensuring, through the coordination of community services, that each resident has access to appropriate medical and psychosocial services, as established in the resident service plan developed under Regulation .28 of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Ensuring that there is appropriate coordination of all components of a resident’s service plan, including necessary transportation and delivery of needed supplies;</text> </paragraph> <paragraph num="(g)"> <text>Ensuring that there is appropriate oversight and monitoring of the implementation of each resident’s service plan;</text> </paragraph> <paragraph num="(h)"> <text>Ensuring that all record keeping conforms to the requirements of this chapter and other applicable laws;</text> </paragraph> <paragraph num="(i)"> <text>Ensuring that all requirements of this chapter and other applicable laws are met;</text> </paragraph> <paragraph num="(j)"> <text>Implementing a nursing or clinical order of the delegating nurse or documenting in the resident’s record why the order should not be implemented;</text> </paragraph> <paragraph num="(k)"> <text>Notifying the Department:</text> <paragraph num="(i)"> <text>When the manager terminates the program’s contract with or employment of a delegating nurse; and</text> </paragraph> <paragraph num="(ii)"> <text>Of the reason why the contract or employment was terminated;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Notifying the resident and, if applicable, the resident representative or interested family member of any:</text> <paragraph num="(i)"> <text>Significant change in condition of the resident;</text> </paragraph> <paragraph num="(ii)"> <text>Adverse event that may result in a change in condition;</text> </paragraph> <paragraph num="(iii)"> <text>Outcome of the resident’s care that results in an unanticipated consequence; and</text> </paragraph> <paragraph num="(iv)"> <text>Corrective action, if any;</text> </paragraph> </paragraph> <paragraph num="(m)"> <text>Ensuring that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated; and</text> </paragraph> <paragraph num="(n)"> <text>Ensuring that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="80-Hour Assisted Living Manager Training Course."> <paragraph num="A."> <text>In addition to the requirements in Regulation .15 of this chapter, by January 1, 2006, an assisted living manager shall complete an 80-hour manager training course that is approved by the Department.</text> </paragraph> <paragraph num="B."> <text>The completed manager’s training course shall:</text> <paragraph num="(1)"> <text>Consist of 80 hours of course work and include an examination; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the training through in-person courses, virtual training methods, or a combination of both.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An assisted living manager employed in a program shall complete 20 hours of Department-approved continuing education every 2 years.</text> </paragraph> <paragraph num="D."> <text>A program that fails to employ an assisted manager who meets the requirements of this regulation may be subject to:</text> <paragraph num="(1)"> <text>Sanctions under Regulation .57 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>A civil money penalty not to exceed $10,000.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The training requirements of §A of this regulation do not apply to an individual who:</text> <paragraph num="(1)"> <text>Is employed by a program and has enrolled in a Department-approved manager training course that the individual completes within 6 months;</text> </paragraph> <paragraph num="(2)"> <text>Is temporarily serving as an assisted living manager under Health Occupations Article, §9-3A-01, Annotated Code of Maryland, due to an assisted living manager leaving employment and before the hiring of a permanent manager;</text> </paragraph> <paragraph num="(3)"> <text>Has been employed as an assisted living manager in the State for 1 year before January 1, 2006; or</text> </paragraph> <paragraph num="(4)"> <text>Is licensed as a nursing home administrator in the State.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department may require an individual who is exempt under the provisions of §E of this regulation to complete a manager training course and examination if:</text> <paragraph num="(1)"> <text>The Department finds that the assisted living manager repeatedly has violated State law or regulations on assisted living; and</text> </paragraph> <paragraph num="(2)"> <text>Those violations have caused or have the potential to cause physical or emotional harm to a resident.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="80-Hour Assisted Living Manager Basic Training Course."> <paragraph num="A."> <text>The 80-hour assisted living manager basic training course shall include the following content:</text> <paragraph num="(1)"> <text>Philosophy of assisted living, 2 hours, including:</text> <paragraph num="(a)"> <text>Philosophy and background of assisted living and aging in place;</text> </paragraph> <paragraph num="(b)"> <text>Objectives and principles of assisted living resident programs;</text> </paragraph> <paragraph num="(c)"> <text>Comparison of assisted living to other residential programs;</text> </paragraph> <paragraph num="(d)"> <text>Basic concepts of choice, independence, privacy, individuality, and dignity; and</text> </paragraph> <paragraph num="(e)"> <text>Normalization of the environment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aging process and its impact, 4 hours, including:</text> <paragraph num="(a)"> <text>Physical characteristics of the assisted living residents;</text> </paragraph> <paragraph num="(b)"> <text>Psychosocial characteristics of the assisted living residents;</text> </paragraph> <paragraph num="(c)"> <text>Basic needs of the elderly and disabled; and</text> </paragraph> <paragraph num="(d)"> <text>Activities of daily living;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assessment and level of care waiver, 6 hours, including:</text> <paragraph num="(a)"> <text>Purpose and process;</text> </paragraph> <paragraph num="(b)"> <text>Guidelines for conducting assessments;</text> </paragraph> <paragraph num="(c)"> <text>Level of care assessments; and</text> </paragraph> <paragraph num="(d)"> <text>Collaboration with the delegating nurse;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service planning, 6 hours, including:</text> <paragraph num="(a)"> <text>Required services;</text> </paragraph> <paragraph num="(b)"> <text>Enhanced scope of services;</text> </paragraph> <paragraph num="(c)"> <text>Development of individualized service plans;</text> </paragraph> <paragraph num="(d)"> <text>Scheduling of appropriate activities;</text> </paragraph> <paragraph num="(e)"> <text>Structure of activities;</text> </paragraph> <paragraph num="(f)"> <text>Care notes; and</text> </paragraph> <paragraph num="(g)"> <text>Collaboration with the delegating nurse;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Clinical management, 20 hours, including:</text> <paragraph num="(a)"> <text>Role of the delegating nurse;</text> </paragraph> <paragraph num="(b)"> <text>Appropriate nurse delegation;</text> </paragraph> <paragraph num="(c)"> <text>Concept of self-administration of medications;</text> </paragraph> <paragraph num="(d)"> <text>Concept of medication management;</text> </paragraph> <paragraph num="(e)"> <text>Assistance with self-administration of medications;</text> </paragraph> <paragraph num="(f)"> <text>Administration of medications;</text> </paragraph> <paragraph num="(g)"> <text>Coordination of services and care providers;</text> </paragraph> <paragraph num="(h)"> <text>Collaboration with the delegating nurse;</text> </paragraph> <paragraph num="(i)"> <text>Preventing medication errors;</text> </paragraph> <paragraph num="(j)"> <text>Patient safety;</text> </paragraph> <paragraph num="(k)"> <text>Medication monitoring;</text> </paragraph> <paragraph num="(l)"> <text>Pharmacy consultation;</text> </paragraph> <paragraph num="(m)"> <text>Medication storage;</text> </paragraph> <paragraph num="(n)"> <text>Infection prevention and control to include:</text> <paragraph num="(i)"> <text>Standard and contact precautions;</text> </paragraph> <paragraph num="(ii)"> <text>Bloodborne pathogens;</text> </paragraph> <paragraph num="(iii)"> <text>Standard hand hygiene practices;</text> </paragraph> <paragraph num="(iv)"> <text>Safe injection practices;</text> </paragraph> <paragraph num="(v)"> <text>Use of personal protective equipment; and</text> </paragraph> <paragraph num="(vi)"> <text>Cleaning and disinfection of equipment and the environment;</text> </paragraph> </paragraph> <paragraph num="(o)"> <text>Appropriate staffing patterns;</text> </paragraph> <paragraph num="(p)"> <text>Pressure sores;</text> </paragraph> <paragraph num="(q)"> <text>Effective pain management;</text> </paragraph> <paragraph num="(r)"> <text>Basic first aid taught by a first aid instructor certified by a national organization;</text> </paragraph> <paragraph num="(s)"> <text>Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization;</text> </paragraph> <paragraph num="(t)"> <text>Substance abuse;</text> </paragraph> <paragraph num="(u)"> <text>Trauma-informed care; and</text> </paragraph> <paragraph num="(v)"> <text>A trauma-informed approach to care delivery;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Admission and discharge criteria, 4 hours, including:</text> <paragraph num="(a)"> <text>Overview of criteria for admission and discharge;</text> </paragraph> <paragraph num="(b)"> <text>Resident contracts;</text> </paragraph> <paragraph num="(c)"> <text>Resident rights;</text> </paragraph> <paragraph num="(d)"> <text>Financial management of resident’s funds; and</text> </paragraph> <paragraph num="(e)"> <text>Working with families of residents;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Nutrition and food safety, 8 hours, including:</text> <paragraph num="(a)"> <text>Menu and meal planning;</text> </paragraph> <paragraph num="(b)"> <text>Basic nutritional needs;</text> </paragraph> <paragraph num="(c)"> <text>Safe food handling;</text> </paragraph> <paragraph num="(d)"> <text>Preventing food-borne illnesses;</text> </paragraph> <paragraph num="(e)"> <text>Therapeutic diets; and</text> </paragraph> <paragraph num="(f)"> <text>Dehydration;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Dementia, mental health, and behavior management, 12 hours, including:</text> <paragraph num="(a)"> <text>An overview consisting of:</text> <paragraph num="(i)"> <text>Description of normal aging and conditions causing cognitive impairment;</text> </paragraph> <paragraph num="(ii)"> <text>Description of normal aging and conditions causing mental illness;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(iv)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(v)"> <text>Health conditions that affect cognitive impairment;</text> </paragraph> <paragraph num="(vi)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(vii)"> <text>Early identification and intervention for cognitive impairment;</text> </paragraph> <paragraph num="(viii)"> <text>Early identification and intervention for mental illness; and</text> </paragraph> <paragraph num="(ix)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective communication consisting of:</text> <paragraph num="(i)"> <text>Effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(ii)"> <text>Effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(iii)"> <text>Effective communication techniques, including verbal, nonverbal, tone and volume of voice, and word choice; and</text> </paragraph> <paragraph num="(iv)"> <text>Environmental stimuli and influences on communication, including setting, noise, and visual cues;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavioral intervention consisting of:</text> <paragraph num="(i)"> <text>Identifying and interpreting behavioral symptoms;</text> </paragraph> <paragraph num="(ii)"> <text>Problem solving for appropriate intervention;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors and safety precautions to protect other residents and the individual;</text> </paragraph> <paragraph num="(iv)"> <text>De-escalation techniques; and</text> </paragraph> <paragraph num="(v)"> <text>Collaboration with the delegating nurse;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Making activities meaningful consisting of:</text> <paragraph num="(i)"> <text>Understanding the therapeutic role of activities;</text> </paragraph> <paragraph num="(ii)"> <text>Creating opportunities for activities, including productive, leisure, and self-care; and</text> </paragraph> <paragraph num="(iii)"> <text>Structuring the day;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Staff and family interaction consisting of:</text> <paragraph num="(i)"> <text>Building a partnership for goal-directed care;</text> </paragraph> <paragraph num="(ii)"> <text>Understanding family needs; and</text> </paragraph> <paragraph num="(iii)"> <text>Effective communication between family and staff; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Managing staff stress consisting of:</text> <paragraph num="(i)"> <text>Understanding the impact of stress on job performance, staff relations, and overall facility environment;</text> </paragraph> <paragraph num="(ii)"> <text>Identification of stress triggers;</text> </paragraph> <paragraph num="(iii)"> <text>Self-care skills;</text> </paragraph> <paragraph num="(iv)"> <text>De-escalating techniques; and</text> </paragraph> <paragraph num="(v)"> <text>Devising support systems and action plans;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>End of life care, 4 hours, including:</text> <paragraph num="(a)"> <text>Advance directives;</text> </paragraph> <paragraph num="(b)"> <text>Hospice care;</text> </paragraph> <paragraph num="(c)"> <text>Maryland Medical Orders for Life-Sustaining Treatment (MOLST) order form;</text> </paragraph> <paragraph num="(d)"> <text>Power of attorney;</text> </paragraph> <paragraph num="(e)"> <text>Appointment of a health care agent;</text> </paragraph> <paragraph num="(f)"> <text>Living will;</text> </paragraph> <paragraph num="(g)"> <text>Pain management;</text> </paragraph> <paragraph num="(h)"> <text>Providing comfort and dignity; and</text> </paragraph> <paragraph num="(i)"> <text>Supporting the family;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Management and operation, 4 hours, including:</text> <paragraph num="(a)"> <text>Role of the assisted living manager;</text> </paragraph> <paragraph num="(b)"> <text>Overview of accounting, accounts payable, and accounts receivable;</text> </paragraph> <paragraph num="(c)"> <text>The revenue cycle and budgeting;</text> </paragraph> <paragraph num="(d)"> <text>The basics of financial statements;</text> </paragraph> <paragraph num="(e)"> <text>Hiring and training of staff;</text> </paragraph> <paragraph num="(f)"> <text>Developing personnel policies and procedures;</text> </paragraph> <paragraph num="(g)"> <text>Census development; and</text> </paragraph> <paragraph num="(h)"> <text>Marketing;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Emergency planning, 4 hours, including:</text> <paragraph num="(a)"> <text>Fire, disaster, and emergency preparedness;</text> </paragraph> <paragraph num="(b)"> <text>Occupational Safety and Health Administration (OSHA) requirements;</text> </paragraph> <paragraph num="(c)"> <text>Maintaining the building, grounds, and equipment;</text> </paragraph> <paragraph num="(d)"> <text>Elopements;</text> </paragraph> <paragraph num="(e)"> <text>Transfers to the hospital;</text> </paragraph> <paragraph num="(f)"> <text>Evacuations;</text> </paragraph> <paragraph num="(g)"> <text>Power outages;</text> </paragraph> <paragraph num="(h)"> <text>Severe weather;</text> </paragraph> <paragraph num="(i)"> <text>Fire;</text> </paragraph> <paragraph num="(j)"> <text>Emergency response systems; and</text> </paragraph> <paragraph num="(k)"> <text>Security systems;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Quality assurance, 4 hours, including:</text> <paragraph num="(a)"> <text>Incident report processes; and</text> </paragraph> <paragraph num="(b)"> <text>Quality improvement processes; and</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Survey process, 2 hours, including:</text> <paragraph num="(a)"> <text>State statutes and regulations;</text> </paragraph> <paragraph num="(b)"> <text>What to expect during a survey; and</text> </paragraph> <paragraph num="(c)"> <text>Documentation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A person seeking to offer the assisted living manager training course shall request and obtain approval by the Department by:</text> <paragraph num="(1)"> <text>Submitting the proposed curriculum and training materials to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Being available for an in-person or telephone interview by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Alternate Assisted Living Manager."> <text>An alternate assisted living manager shall:</text> <paragraph num="A."> <text>Be available to assume the responsibilities described in Regulation .15C(2)(a)—(l) of this chapter when the assisted living manager is not available;</text> </paragraph> <paragraph num="B."> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="C."> <text>Have 2 years of experience in a health-related field; and</text> </paragraph> <paragraph num="D."> <text>Meet the qualifications of Regulation .19B(1)—(7) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Other Staff — Qualifications."> <paragraph num="A."> <text>Age Requirements of Other Staff.</text> <paragraph num="(1)"> <text>Direct resident care staff shall be:</text> <paragraph num="(a)"> <text>18 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>16 or 17 years old who are enrolled in a certified nursing assistant training program and are supervised until certified; or</text> </paragraph> <paragraph num="(c)"> <text>16 or 17 years old and are certified as a nursing assistant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Other staff not performing direct resident care may be younger than 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualifications of Other Staff. The qualifications of other staff include:</text> <paragraph num="(1)"> <text>Evidence that the staff is:</text> <paragraph num="(a)"> <text>Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities;</text> </paragraph> <paragraph num="(b)"> <text>Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; and</text> </paragraph> <paragraph num="(c)"> <text>Free from any impairment which would hinder the performance of assigned responsibilities;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Having no criminal convictions or criminal history that indicates behavior that is potentially harmful to residents, as evidenced through a background check completed within 30 calendar days before employment;</text> </paragraph> <paragraph num="(3)"> <text>Having sufficient skills, education, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living;</text> </paragraph> <paragraph num="(4)"> <text>Participating in and completing an orientation program and ongoing training to ensure that the residents receive services that are consistent with their needs and generally accepted standards of care for the specific conditions of those residents to whom staff will provide services;</text> </paragraph> <paragraph num="(5)"> <text>Receiving initial and annual training in:</text> <paragraph num="(a)"> <text>Fire and life safety, including the use of fire extinguishers;</text> </paragraph> <paragraph num="(b)"> <text>Infection control, including standard precautions, contact precautions, and hand hygiene;</text> </paragraph> <paragraph num="(c)"> <text>Basic food safety; and</text> </paragraph> <paragraph num="(d)"> <text>Emergency disaster plans;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Completing basic first aid training taught by a first aid instructor certified by a national organization and recertification every 2 years;</text> <paragraph num="(a)"> <text>Licensed practical nurses and registered nurses are exempted from basic first aid training and retraining.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Having training or experience in:</text> <paragraph num="(a)"> <text>The health and psychosocial needs of the population being served as appropriate to their job responsibilities;</text> </paragraph> <paragraph num="(b)"> <text>The resident assessment process;</text> </paragraph> <paragraph num="(c)"> <text>The use of service plans; and</text> </paragraph> <paragraph num="(d)"> <text>Resident’s rights; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Holding appropriate licensure or certification as required by law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>With the exception of certified nursing assistants (CNAs) and geriatric nursing assistants (GNAs), if job duties involve the provision of personal care services as described in Regulation .30E of this chapter, an employee:</text> <paragraph num="(1)"> <text>Shall demonstrate competence to the delegating nurse before performing these services; and</text> </paragraph> <paragraph num="(2)"> <text>May work for 10 calendar days before demonstrating to the delegating nurse that they have the competency to provide these services, if the employee performing the tasks is accompanied by:</text> <paragraph num="(a)"> <text>A certified nursing assistant;</text> </paragraph> <paragraph num="(b)"> <text>A geriatric nursing assistant; or</text> </paragraph> <paragraph num="(c)"> <text>An individual who has been approved by the delegating nurse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Basic cardiopulmonary resuscitation (CPR) training, including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization shall be provided on an initial and ongoing basis to a sufficient number of staff to ensure that a trained staff member is available to perform CPR in a timely manner, 24 hours a day.</text> </paragraph> <paragraph num="E."> <text>Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable. Relief personnel shall meet the requirements of §B of this regulation.</text> </paragraph> <paragraph num="F."> <text>Proof of training shall include:</text> <paragraph num="(1)"> <text>Date of class;</text> </paragraph> <paragraph num="(2)"> <text>Course content;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of successful completion of the training content;</text> </paragraph> <paragraph num="(4)"> <text>Written, electronic, or video proof of attendee participation; and</text> </paragraph> <paragraph num="(5)"> <text>Signature, qualifications, and contact information of each trainer.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Training with No Direct Interaction. When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant a trained individual to answer questions and respond to issues during the training.</text> </paragraph> <paragraph num="H."> <text>Training in Cognitive Impairment, Mental Illness, and Behavioral Health.</text> <paragraph num="(1)"> <text>When job duties involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 6 hours of initial training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment.</text> </paragraph> <paragraph num="(2)"> <text>The training shall be designed to meet the specific needs of the assisted living program’s population as determined by the assisted living manager, including the following, as appropriate:</text> <paragraph num="(a)"> <text>An overview of the following:</text> <paragraph num="(i)"> <text>A description of normal aging and conditions causing cognitive impairment;</text> </paragraph> <paragraph num="(ii)"> <text>A description of normal aging and conditions causing mental illness;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(iv)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(v)"> <text>Health conditions that affect cognitive impairment;</text> </paragraph> <paragraph num="(vi)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(vii)"> <text>Early identification of and intervention for cognitive impairment;</text> </paragraph> <paragraph num="(viii)"> <text>Early identification of and intervention for mental illness; and</text> </paragraph> <paragraph num="(ix)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective communication, including:</text> <paragraph num="(i)"> <text>The effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(ii)"> <text>The effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(iii)"> <text>Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and</text> </paragraph> <paragraph num="(iv)"> <text>Environmental stimuli and influences on communication;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavioral intervention, including:</text> <paragraph num="(i)"> <text>Identifying and interpreting behavioral symptoms;</text> </paragraph> <paragraph num="(ii)"> <text>Problem solving for appropriate intervention;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors and safety precautions to protect the individual and other residents; and</text> </paragraph> <paragraph num="(iv)"> <text>De-escalation techniques;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Making activities meaningful, including:</text> <paragraph num="(i)"> <text>Understanding the therapeutic role of activities;</text> </paragraph> <paragraph num="(ii)"> <text>Creating opportunities for productive, leisure, and self-care activities; and</text> </paragraph> <paragraph num="(iii)"> <text>Structuring the day;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Staff and family interaction, including:</text> <paragraph num="(i)"> <text>Building a partnership for goal-directed care;</text> </paragraph> <paragraph num="(ii)"> <text>Understanding the needs of families; and</text> </paragraph> <paragraph num="(iii)"> <text>Effective communication between family and staff;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>End of life care, including:</text> <paragraph num="(i)"> <text>Pain management;</text> </paragraph> <paragraph num="(ii)"> <text>Providing comfort and dignity; and</text> </paragraph> <paragraph num="(iii)"> <text>Supporting the family; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Managing staff stress, including:</text> <paragraph num="(i)"> <text>Understanding the impact of stress on job performance, staff relations, and overall facility environment;</text> </paragraph> <paragraph num="(ii)"> <text>Identification of stress triggers;</text> </paragraph> <paragraph num="(iii)"> <text>Self-care skills;</text> </paragraph> <paragraph num="(iv)"> <text>De-escalation techniques; and</text> </paragraph> <paragraph num="(v)"> <text>Devising support systems and action plans.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>When job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 2 hours of training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment. The training shall include:</text> <paragraph num="(a)"> <text>An overview of the following:</text> <paragraph num="(i)"> <text>A description of normal aging and conditions causing cognitive impairment;</text> </paragraph> <paragraph num="(ii)"> <text>A description of normal aging and conditions causing mental illness;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(iv)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(v)"> <text>Health conditions that affect cognitive impairment;</text> </paragraph> <paragraph num="(vi)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(vii)"> <text>Early identification and intervention for cognitive impairment;</text> </paragraph> <paragraph num="(viii)"> <text>Early identification and intervention for mental illness; and</text> </paragraph> <paragraph num="(ix)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective communication, including:</text> <paragraph num="(i)"> <text>The effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(ii)"> <text>The effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(iii)"> <text>Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and</text> </paragraph> <paragraph num="(iv)"> <text>Environmental stimuli and influences on communication; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavioral intervention including risk factors and safety precautions to protect the individual and other residents.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ongoing training in cognitive impairment and mental illness shall be provided annually consisting of, at a minimum:</text> <paragraph num="(a)"> <text>2 hours for employees whose job duties involve the provision of personal care services as described in Regulation .30E of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>1 hour for employees whose job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Training may be provided through various means, including:</text> <paragraph num="(1)"> <text>Classroom instruction;</text> </paragraph> <paragraph num="(2)"> <text>In-service training;</text> </paragraph> <paragraph num="(3)"> <text>Internet courses;</text> </paragraph> <paragraph num="(4)"> <text>Correspondence courses;</text> </paragraph> <paragraph num="(5)"> <text>Prerecorded training; or</text> </paragraph> <paragraph num="(6)"> <text>Other training methods approved by the Department.</text> </paragraph> </paragraph> <paragraph num="J."> <text>When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Personnel Records."> <text>The assisted living program shall maintain the following information for each staff member:</text> <paragraph num="A."> <text>Full name, age, and gender;</text> </paragraph> <paragraph num="B."> <text>Address and telephone number;</text> </paragraph> <paragraph num="C."> <text>Educational background;</text> </paragraph> <paragraph num="D."> <text>Employment history;</text> </paragraph> <paragraph num="E."> <text>Notes on references;</text> </paragraph> <paragraph num="F."> <text>Performance evaluations;</text> </paragraph> <paragraph num="G."> <text>Attendance records;</text> </paragraph> <paragraph num="H."> <text>Individual to be notified in case of emergency;</text> </paragraph> <paragraph num="I."> <text>Documentation that a criminal history records check was conducted in accordance with Health-General Article, §19-1901, Annotated Code of Maryland;</text> </paragraph> <paragraph num="J."> <text>Documentation that the staff is:</text> <paragraph num="(1)"> <text>Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; and</text> </paragraph> <paragraph num="(2)"> <text>Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Evidence that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated;</text> </paragraph> <paragraph num="L."> <text>Evidence that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated;</text> </paragraph> <paragraph num="M."> <text>Documentation of appropriate licensure or certification as required by law;</text> </paragraph> <paragraph num="N."> <text>Documentation of all required training and courses; and</text> </paragraph> <paragraph num="O."> <text>Documentation that a check of the federal Department of Health and Human Services, Office of the Inspector General’s List of Excluded Individuals/Entities database was conducted prior to hiring.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Delegating Nurse."> <paragraph num="A."> <text>The assisted living program shall have a current and signed agreement with a registered nurse for services of a delegating nurse and delegation of nursing tasks. If the delegating nurse is an employee of the assisted living program, the employee’s job description may satisfy this requirement.</text> </paragraph> <paragraph num="B."> <text>The program shall maintain documentation that the delegating nurse has completed the mandatory training course developed by the Board of Nursing.</text> </paragraph> <paragraph num="C."> <text>Duties. The delegating nurse shall:</text> <paragraph num="(1)"> <text>Be on-site to observe each resident at least every 45 calendar days;</text> </paragraph> <paragraph num="(2)"> <text>Be available on call at all times as required under this chapter or have a qualified alternate delegating nurse available on call; and</text> </paragraph> <paragraph num="(3)"> <text>Have the overall responsibility for:</text> <paragraph num="(a)"> <text>Managing the clinical oversight of resident care in the assisted living program;</text> </paragraph> <paragraph num="(b)"> <text>Issuing nursing or clinical orders, based upon the needs of residents;</text> </paragraph> <paragraph num="(c)"> <text>Reviewing the assisted living manager’s assessment of residents;</text> </paragraph> <paragraph num="(d)"> <text>Appropriate delegation of nursing tasks; and</text> </paragraph> <paragraph num="(e)"> <text>Notifying the Department:</text> <paragraph num="(i)"> <text>If the delegating nurse’s contract or employment with the assisted living program is terminated; and</text> </paragraph> <paragraph num="(ii)"> <text>Of the reason why the contract or employment was terminated.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If the delegating nurse is not available to perform any duties, there shall be a qualified alternate delegating nurse available to perform those duties.</text> </paragraph> <paragraph num="E."> <text>When an assisted living manager fails to implement nursing or clinical orders without identifying alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the Department, and the resident, or, if applicable, the resident representative.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Preadmission Requirements."> <paragraph num="A."> <text>Before Move In.</text> <paragraph num="(1)"> <text>Before admission the assisted living manager or designee in collaboration with the delegating nurse shall determine whether:</text> <paragraph num="(a)"> <text>The resident may be admitted under the assisted living program’s licensure category;</text> </paragraph> <paragraph num="(b)"> <text>Requires a level of care that the Department has approved for the assisted living program; and</text> </paragraph> <paragraph num="(c)"> <text>The resident’s needs can be met by the program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 30 days before admission, the assisted living manager or designee shall determine admission eligibilities described in §A(1) of this regulation based on completion of a resident assessment using the Resident Assessment Tool as described in §B of this regulation. The Department may modify the level of care determination made by the assisted living program at any time. The Resident Assessment Tool:</text> <paragraph num="(a)"> <text>Determines the resident’s required level of care;</text> </paragraph> <paragraph num="(b)"> <text>Forms the basis for development of the resident’s service plan; and</text> </paragraph> <paragraph num="(c)"> <text>Determines whether the resident needs awake overnight monitoring.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Resident Assessment Tool.</text> <paragraph num="(1)"> <text>Within 30 days prior to admission, the prospective resident’s health status shall be documented on the Resident Assessment Tool.</text> </paragraph> <paragraph num="(2)"> <text>Information on the Resident Assessment Tool shall be based on an examination conducted by a primary physician, certified nurse practitioner, certified registered nurse midwife, registered nurse, or physician assistant that is based on the resident’s current health status.</text> </paragraph> <paragraph num="(3)"> <text>If the potential resident is admitted on an emergency basis by a local department of social services, the required assessment using the Resident Assessment Tool shall be completed as soon as possible but no later than 14 calendar days after the emergency admission.</text> </paragraph> <paragraph num="(4)"> <text>Information on the assessment shall include at a minimum:</text> <paragraph num="(a)"> <text>Recent medical history, including any acute medical conditions or hospitalizations;</text> </paragraph> <paragraph num="(b)"> <text>Significant medical conditions affecting functioning, including the individual’s ability for self-care, cognition, physical condition, and behavioral and psychosocial status;</text> </paragraph> <paragraph num="(c)"> <text>Other active and significant chronic or acute medical diagnoses;</text> </paragraph> <paragraph num="(d)"> <text>Known allergies to foods and medications;</text> </paragraph> <paragraph num="(e)"> <text>Medical confirmation that the individual is free from communicable tuberculosis, and other active reportable airborne communicable diseases;</text> </paragraph> <paragraph num="(f)"> <text>Current scheduled and as needed (PRN) medications;</text> </paragraph> <paragraph num="(g)"> <text>Current and other needed treatments and services for medical conditions and related problems;</text> </paragraph> <paragraph num="(h)"> <text>Current nutritional status, risk factors for malnutrition and dehydration, and, if available, height and weight;</text> </paragraph> <paragraph num="(i)"> <text>Diets ordered by a health care practitioner;</text> </paragraph> <paragraph num="(j)"> <text>Medically necessary limitations or precautions; and</text> </paragraph> <paragraph num="(k)"> <text>Monitoring or tests that need to be performed or followed up after admission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Reassessment Documented on the Resident Assessment Tool.</text> <paragraph num="(1)"> <text>The Resident Assessment Tool shall be reviewed at least every 6 months and the review shall be documented by the delegating nurse and assisted living manager.</text> </paragraph> <paragraph num="(2)"> <text>A new Resident Assessment Tool shall be completed:</text> <paragraph num="(a)"> <text>At least annually;</text> </paragraph> <paragraph num="(b)"> <text>Within 48 hours, but not later than required by the resident’s condition, after a significant change in a resident’s condition; and</text> </paragraph> <paragraph num="(c)"> <text>Within 48 hours of a delegating nurse’s determination that a new Resident Assessment Tool needs to be completed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the previous Resident Assessment Tool did not indicate the need for awake overnight staff, each reassessment or review of the assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Functional Assessment. Within 30 calendar days before admission, the assisted living manager, or designee, shall collect on the Resident Assessment Tool the following information regarding the current condition of each resident:</text> <paragraph num="(1)"> <text>Level of functioning in activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Level of support and intervention needed, including any special equipment and supplies required to compensate for the individual’s deficits in activities of daily living;</text> </paragraph> <paragraph num="(3)"> <text>Current physical or psychological symptoms requiring monitoring, support, or other intervention by the assisted living program;</text> </paragraph> <paragraph num="(4)"> <text>Capacity for making personal and health care related decisions;</text> </paragraph> <paragraph num="(5)"> <text>Presence of disruptive behaviors, or behaviors which present a risk to the health and safety of the resident or others; and</text> </paragraph> <paragraph num="(6)"> <text>Social factors, including:</text> <paragraph num="(a)"> <text>Significant problems with family circumstances and personal relationships;</text> </paragraph> <paragraph num="(b)"> <text>Spiritual status and needs; and</text> </paragraph> <paragraph num="(c)"> <text>Ability to participate in structured and group activities, and the resident’s current involvement in these activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Resident Requirements for Awake Overnight Staff.</text> <paragraph num="(1)"> <text>Before admission, the assisted living manager shall ensure that the resident is assessed using the Resident Assessment Tool.</text> </paragraph> <paragraph num="(2)"> <text>When the resident scores in any of the areas identified as “Triggers for Awake Overnight Staff” in the Resident Assessment Tool, the assisted living program shall provide awake overnight staff or document why awake overnight staff is not necessary in accordance with Regulation .14E of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Short-Term Residential Care Requirements.</text> <paragraph num="(1)"> <text>For persons admitted for short-term residential care, the following are required:</text> <paragraph num="(a)"> <text>Current physical condition and medical status as specified in §B(4) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Functional assessment as specified in §D of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>A resident agreement, in accordance with Regulations .26 and .27 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the person is admitted for a subsequent short-term admission, the following are required:</text> <paragraph num="(a)"> <text>Current physical condition and medical status as specified in §B(4) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Functional assessment as specified in §D of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>A new resident agreement or an addendum to the prior resident agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A resident admitted as an emergency placement by a local department of social services is exempt from all physical examination and assessment requirements of this regulation if the resident is in temporary emergency shelter and services status, not to exceed 14 calendar days, with notification to the Department of the placement within 48 hours.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Admission Requirements."> <paragraph num="A."> <text>Discrimination Prohibited. An assisted living program licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Color;</text> </paragraph> <paragraph num="(3)"> <text>National origin;</text> </paragraph> <paragraph num="(4)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(5)"> <text>Gender identity;</text> </paragraph> <paragraph num="(6)"> <text>Religion;</text> </paragraph> <paragraph num="(7)"> <text>Physical disability; or</text> </paragraph> <paragraph num="(8)"> <text>Mental disability.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An assisted living program may not provide services to individuals who at the time of initial admission, as established by the initial assessment, would require:</text> <paragraph num="(1)"> <text>More than intermittent nursing care;</text> </paragraph> <paragraph num="(2)"> <text>Treatment of stage three or stage four skin ulcers;</text> </paragraph> <paragraph num="(3)"> <text>Ventilator services;</text> </paragraph> <paragraph num="(4)"> <text>Skilled monitoring, testing, and frequent adjustment of medications and treatments where there is the presence of a fluctuating acute condition; or</text> </paragraph> <paragraph num="(5)"> <text>Monitoring of a chronic medical condition that is not controllable through readily available medications and treatments.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual may not be admitted to an assisted living program who is:</text> <paragraph num="(1)"> <text>Dangerous to the individual or others when the assisted living program would be unable to eliminate the danger through the use of appropriate treatment modalities; or</text> </paragraph> <paragraph num="(2)"> <text>At high risk for health or safety complications which cannot be adequately managed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provisions of §§B and C of this regulation do not apply to a resident being admitted to an assisted living program when the resident is under the care of a general hospice care program licensed by the Department which ensures delivery of one or more of the services described under §§B and C of this regulation through the hospice program’s plan of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Resident-Specific Level of Care Waiver."> <paragraph num="A."> <text>An assisted living program may request a resident-specific waiver to continue to provide services to a resident if:</text> <paragraph num="(1)"> <text>The resident’s level of care exceeds the level of care for which the assisted living program has authority to provide; or</text> </paragraph> <paragraph num="(2)"> <text>The resident would require care that falls into one of the categories set forth in Regulation .23.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An assisted living program may not continue providing services to a resident whose needs exceed the level of care for which the licensee has authority to provide, without approval of the Department.</text> </paragraph> <paragraph num="C."> <text>Temporary Change in Level of Care.</text> <paragraph num="(1)"> <text>A level of care waiver is not required for a resident whose level of care is expected to increase for a period not to exceed 30 calendar days.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall submit a waiver application as soon as program personnel determine that the increased level of care or the condition requiring the waiver is likely to exceed 30 calendar days.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When requesting a resident-specific waiver, the assisted living program shall demonstrate that:</text> <paragraph num="(1)"> <text>The assisted living program has the capability of meeting the needs of the resident; and</text> </paragraph> <paragraph num="(2)"> <text>The needs of other residents will not be jeopardized.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Approval of Waiver Request.</text> <paragraph num="(1)"> <text>The Department may grant a resident-specific level of care waiver, with or without conditions, if the Department determines that the:</text> <paragraph num="(a)"> <text>Resident’s needs can be met;</text> </paragraph> <paragraph num="(b)"> <text>Needs of other residents will not be jeopardized; and</text> </paragraph> <paragraph num="(c)"> <text>Provider complies with the requirements of Regulation .47A of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Terms of a Resident-Specific Waiver.</text> <paragraph num="(a)"> <text>An approved resident-specific waiver applies only to the resident for whom the waiver was granted.</text> </paragraph> <paragraph num="(b)"> <text>The waiver no longer applies if the resident’s level of care, as determined through an assessment, declines or improves to the point that the resident requires a higher or lower level of care than authorized by the waiver.</text> </paragraph> <paragraph num="(c)"> <text>When the Department grants a waiver to continue to provide services to a resident whose needs fall within one of the categories in Regulation .23, the assisted living program shall, at a minimum, comply with certain federal Medicare requirements for home health agencies referenced in 42 CFR §§484.1, 484.2, 484.40—484.80, 484.100—484.115, 484.200—484.265, and 484.300—484.375.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Denial of a Resident-Specific Waiver Request.</text> <paragraph num="(1)"> <text>The Department shall deny the request for a resident-specific waiver if the Department determines that the:</text> <paragraph num="(a)"> <text>Assisted living program is not capable of meeting the needs of the resident; or</text> </paragraph> <paragraph num="(b)"> <text>Needs of other residents will be jeopardized if the waiver request is granted.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not grant resident-specific waivers:</text> <paragraph num="(a)"> <text>That total more than 50 percent of the assisted living program’s bed capacity for residents whose needs exceed the level of care for which the assisted living program has authority to provide as specified in Regulation .04D of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>For the continuation of services to a resident whose needs fall within one of the categories set forth in .23B of this regulation, for up to 20 percent of capacity, or 20 beds, whichever is less, unless a waiver is granted by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The decision of the Department may not be appealed.</text> </paragraph> <paragraph num="(4)"> <text>The Department’s denial of a resident-specific level of care waiver request:</text> <paragraph num="(a)"> <text>Does not prohibit the resident from being admitted to another program that is capable of meeting the resident’s needs and is licensed to provide that level of care; and</text> </paragraph> <paragraph num="(b)"> <text>Does not provide any exception to the admission restrictions set forth in .23A of this regulation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the Department initially denies a resident-specific level of care waiver request and determines that a resident’s health or safety may significantly deteriorate because of the provider’s inability to provide or ensure access to care that will meet the needs of the resident, the:</text> <paragraph num="(a)"> <text>Denial is not subject to informal dispute resolution; and</text> </paragraph> <paragraph num="(b)"> <text>Department may direct the relocation of the resident to a safe environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Department’s Decision.</text> <paragraph num="(1)"> <text>The Department shall communicate the decision to grant or deny a resident-specific waiver to the assisted living manager in writing, including all appropriate supporting documentation, within 7 calendar days from receipt of the waiver request.</text> </paragraph> <paragraph num="(2)"> <text>Dispute of a Resident-Specific Waiver.</text> <paragraph num="(a)"> <text>If the resident or the resident representative disagrees with the Department’s denial of a waiver request, the resident or, as applicable, the resident representative may dispute the Department’s decision by:</text> <paragraph num="(i)"> <text>Submitting a written request to the Department within 7 calendar days after receipt of the Department’s denial; and</text> </paragraph> <paragraph num="(ii)"> <text>Including in the written request the reasons why the Department’s denial may be incorrect.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Department shall consider the request and notify the resident or the resident representative within 7 calendar days of receipt of the request whether or not the Department’s decision to deny a level of care waiver is sustained.</text> </paragraph> <paragraph num="(c)"> <text>The Department’s decision from the dispute is not:</text> <paragraph num="(i)"> <text>A contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Subject to further appeal.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>In making a decision to sustain or change the decision to deny a waiver request, the Department shall consider, among other factors, whether the:</text> <paragraph num="(i)"> <text>Granting of waivers has resulted in one or more residents having experienced a decline in their physical, functional, or psychosocial well-being; and</text> </paragraph> <paragraph num="(ii)"> <text>Decline in the residents’ condition might have been prevented had the waivers not been granted.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If the Department sustains the decision to deny the waiver request, the Department shall notify the assisted living program of what action is required, including, but not limited to:</text> <paragraph num="(i)"> <text>Revocation of some or all of the resident-specific waivers which have been granted; or</text> </paragraph> <paragraph num="(ii)"> <text>A change in licensure category.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Decision to Sustain the Denial of Waiver Request.</text> <paragraph num="(i)"> <text>Upon notification of the decision to sustain the denial of waiver, the assisted living program shall submit a response with an appropriate plan of action for approval by the Department.</text> </paragraph> <paragraph num="(ii)"> <text>If the Department does not approve the assisted living program’s plan of action, the Department shall notify the assisted living program that one or more resident-specific waivers are revoked or that a change in licensure status is required.</text> </paragraph> <paragraph num="(iii)"> <text>The determination to sustain the denial of waiver request may not be appealed.</text> </paragraph> <paragraph num="(iv)"> <text>Failure of the assisted living program to comply with the Department’s decision is grounds for the imposition of sanctions.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>The Department shall, during a survey or other inspection, or when a resident-specific level of care waiver request is made, review the number of resident-specific waivers an assisted living program holds to ensure that the assisted living program continues to be able to provide appropriate care to all of its residents and to ensure that the current licensure category is appropriate. The Department shall notify the assisted living program if, at any time, the Department determines that:</text> <paragraph num="(1)"> <text>The assisted living program is not providing appropriate care to its residents because of the number of resident-specific waivers it holds; or</text> </paragraph> <paragraph num="(2)"> <text>The number of resident-specific waivers an assisted living program holds necessitates a change in licensure category.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Payment of Funds Before Admission."> <text>If an assisted living program requires payment of funds before admission, the funds shall be fully refundable unless the assisted living program discloses, in writing, what portion is not refundable.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Resident Agreement — General Requirements and Nonfinancial Content."> <paragraph num="A."> <text>Except as otherwise provided under §E of this regulation, for a person admitted for other than short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement that:</text> <paragraph num="(1)"> <text>Is a clear and complete reflection of commitments agreed to by the parties, and the actual practices that will occur in the assisted living program;</text> </paragraph> <paragraph num="(2)"> <text>Is accurate, precise, easily understood, legible, readable, and written in plain English;</text> </paragraph> <paragraph num="(3)"> <text>Conforms to all relevant State and local laws and requirements in effect when the agreement is executed; and</text> </paragraph> <paragraph num="(4)"> <text>Recommends review of the agreement by an attorney or other representative chosen by the resident.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For a person admitted for short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement as set forth in this regulation excluding the provisions of §D(9)(c) and 8(d) and (e) of this regulation.</text> </paragraph> <paragraph num="C."> <text>The assisted living program shall:</text> <paragraph num="(1)"> <text>Give a copy of the signed resident agreement to the resident and the resident agent;</text> </paragraph> <paragraph num="(2)"> <text>Maintain a copy of the resident agreement on-site; and</text> </paragraph> <paragraph num="(3)"> <text>Make the resident agreement available for review by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The resident agreement shall include, at a minimum, the following provisions:</text> <paragraph num="(1)"> <text>A statement of the level of care for which the assisted living program is licensed;</text> </paragraph> <paragraph num="(2)"> <text>The level of care needed by the resident, as determined by the initial assessment required by Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Unless the assisted living program is part of a continuing care retirement community and the agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if a resident’s level of care, after admission, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted, the assisted living program shall discharge the resident from the program;</text> </paragraph> <paragraph num="(4)"> <text>If the assisted living program is part of a continuing care retirement community and a separate, concurrent resident agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if the resident’s level of care, after admission to assisted living, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted:</text> <paragraph num="(a)"> <text>The assisted living program may not provide any services to the resident beyond that which it is licensed to provide;</text> </paragraph> <paragraph num="(b)"> <text>If the assisted living program offers either comprehensive care services, or priority access to comprehensive care services, and a comprehensive care bed is available for occupancy, the resident shall be given the option to transfer to comprehensive care; and</text> </paragraph> <paragraph num="(c)"> <text>The resident may be discharged from the continuing care retirement community only for just cause as set forth in COMAR 32.02.01.31B;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A listing of services provided by the assisted living program and a listing of personal care and health care services the assisted living program does not provide;</text> </paragraph> <paragraph num="(6)"> <text>An explanation of the assisted living program’s complaint or grievance procedure;</text> </paragraph> <paragraph num="(7)"> <text>A policy on resident self-administration of medications;</text> </paragraph> <paragraph num="(8)"> <text>A policy on the administration of medications to a resident by a spouse or domestic partner who is also a resident of the assisted living program;</text> </paragraph> <paragraph num="(9)"> <text>Occupancy provisions, including:</text> <paragraph num="(a)"> <text>Policies regarding bed and room assignment, including the specific room and bed assigned to the resident at the time of admission;</text> </paragraph> <paragraph num="(b)"> <text>Policies for temporary or permanent changes to the resident’s accommodations, including:</text> <paragraph num="(i)"> <text>Relocating the resident within the facility;</text> </paragraph> <paragraph num="(ii)"> <text>Making a change in roommate assignment; or</text> </paragraph> <paragraph num="(iii)"> <text>Increasing or decreasing the number of individuals occupying a room;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Procedures for transferring the resident to another facility;</text> </paragraph> <paragraph num="(d)"> <text>The availability of locks for storage;</text> </paragraph> <paragraph num="(e)"> <text>The availability of locks, if any, for the resident’s room;</text> </paragraph> <paragraph num="(f)"> <text>Security procedures which the assisted living program shall implement to protect the resident and the resident’s property;</text> </paragraph> <paragraph num="(g)"> <text>The staff’s right, if any, to enter a resident’s room;</text> </paragraph> <paragraph num="(h)"> <text>The resident’s rights and obligations concerning use of the facility, including common areas;</text> </paragraph> <paragraph num="(i)"> <text>If non-residents live on the premises, the assisted living program shall disclose what parts of the licensed space they are permitted in and during what hours;</text> </paragraph> <paragraph num="(j)"> <text>Provisions for continuous service in the event of an emergency;</text> </paragraph> <paragraph num="(k)"> <text>An acknowledgment that the resident or the resident representative has reviewed all assisted living program rules, requirements, restrictions, or special conditions that the assisted living program will impose on the resident; and</text> </paragraph> <paragraph num="(l)"> <text>The assisted living program’s bed hold policy in case of unavoidable or optional absences such as hospitalizations, recuperative stays in other settings, or vacation, including:</text> <paragraph num="(i)"> <text>The conditions under which the assisted living program will hold a bed;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant time frames;</text> </paragraph> <paragraph num="(iii)"> <text>Payment terms;</text> </paragraph> <paragraph num="(iv)"> <text>The circumstances under which the program will no longer hold the bed; and</text> </paragraph> <paragraph num="(v)"> <text>The period of time during which the resident is permitted to return and resume residence in the facility;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Admission and discharge policies and procedures, including:</text> <paragraph num="(a)"> <text>Any additional admission requirement imposed by the assisted living program;</text> </paragraph> <paragraph num="(b)"> <text>Those actions, circumstances, or conditions which may result in the resident’s discharge from the assisted living program;</text> </paragraph> <paragraph num="(c)"> <text>The procedures which the assisted living program shall follow to verify that the receiving program or facility has the required license to operate that type of program or facility;</text> </paragraph> <paragraph num="(d)"> <text>The procedures which the assisted living program shall follow when discharging a resident without the resident’s consent, except in the case of a health emergency or substantial risk to other residents, including:</text> <paragraph num="(i)"> <text>The termination of the resident agreement on discharge; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 30 calendar days written notice to the resident or resident representative before the effective date of the discharge;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Procedures that the assisted living program shall follow when discharging, without 30 calendar days notice, a hospitalized resident whose medical needs have advanced beyond the level of care for which the assisted living program is licensed to provide. The procedures shall include at a minimum:</text> <paragraph num="(i)"> <text>A statement that a transfer to the hospital is not grounds for discharge; and</text> </paragraph> <paragraph num="(ii)"> <text>A requirement that the delegating nurse shall perform and document a nursing assessment of the resident’s condition at the hospital to determine if the resident can safely return to the facility;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Procedures that the resident shall follow when terminating the resident agreement;</text> </paragraph> <paragraph num="(g)"> <text>A statement that the resident or resident representative shall give at least 30 calendar days notice to the assisted living program before the effective date of termination except in the case of a health emergency;</text> </paragraph> <paragraph num="(h)"> <text>Procedures the assisted living program shall follow when a multiple person unit is vacated by one resident due to discharge or death, including provisions:</text> <paragraph num="(i)"> <text>For termination of the agreement; and</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate refunds;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>Obligations of the licensee, the resident, or the resident representative as to:</text> <paragraph num="(a)"> <text>Arranging for or overseeing medical care; and</text> </paragraph> <paragraph num="(b)"> <text>The monitoring of the health status of the resident;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Adult medical day care policies and availability; and</text> </paragraph> <paragraph num="(13)"> <text>Any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to:</text> <paragraph num="(a)"> <text>Financial;</text> </paragraph> <paragraph num="(b)"> <text>Religion preferred funeral director, if any; and</text> </paragraph> <paragraph num="(c)"> <text>The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>If the services provided in an assisted living program that is part of a continuing care retirement community are covered under a continuing care agreement that complies with Human Services Article, Title 10, Subtitle 4, and Health-General Article, §19-1806, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>The Department may not require a separate resident agreement for the assisted living program; and</text> </paragraph> <paragraph num="(2)"> <text>The requirements set forth in this regulation and Regulation .27 of this chapter do not apply.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The assisted living program may not include a provision in the agreement which is inconsistent with any of the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Resident Agreement — Financial Content."> <paragraph num="A."> <text>The resident agreement shall include financial provisions, which include at a minimum:</text> <paragraph num="(1)"> <text>Obligations of the assisted living program and the resident, or the resident agent, as to:</text> <paragraph num="(a)"> <text>Handling the finances of the resident;</text> </paragraph> <paragraph num="(b)"> <text>The purchase or rental of essential or desired equipment and supplies;</text> </paragraph> <paragraph num="(c)"> <text>Arranging and contracting for services not covered by the resident agreement;</text> </paragraph> <paragraph num="(d)"> <text>Ascertaining the cost of and purchasing durable medical equipment; and</text> </paragraph> <paragraph num="(e)"> <text>Disposition of resident property upon discharge or death of the resident; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Rate structure and payment provisions covering:</text> <paragraph num="(a)"> <text>All rates to be charged to the resident, including, but not limited to:</text> <paragraph num="(i)"> <text>Service packages;</text> </paragraph> <paragraph num="(ii)"> <text>Fee for service rates; and</text> </paragraph> <paragraph num="(iii)"> <text>Any other non-service-related charges;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Notification of the rate structure applicable for other levels of care provided by the assisted living program and the criteria to be used for imposing additional charges for the provision of additional services, if the resident’s service and care needs change;</text> </paragraph> <paragraph num="(c)"> <text>Payment arrangements and fees, if known, for third-party services not covered by the resident agreement, but arranged for by either the resident, the resident agent, or the assisted living program;</text> </paragraph> <paragraph num="(d)"> <text>Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the resident’s funds;</text> </paragraph> <paragraph num="(e)"> <text>A provision which provides at least 45 calendar days notice of any rate increase, except if necessitated by a change in the resident’s medical condition;</text> </paragraph> <paragraph num="(f)"> <text>Fair and reasonable billing, payment, and credit policies;</text> </paragraph> <paragraph num="(g)"> <text>The procedures the assisted living program will follow in the event the resident or resident agent can no longer pay for services provided for in the resident agreement or for services or care needed by the resident, including 30 calendar days notice of the resident’s discharge to the:</text> <paragraph num="(i)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(ii)"> <text>Local Department of Human Services or Adult Protective Services; and</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Terms governing the refund of any prepaid fees or charges, in the event of a resident’s discharge from the assisted living program or termination of the resident agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When the resident’s needs significantly change and the level of service provided needs to be increased or decreased, the resident agreement shall be amended by the parties to reflect the changes in services being provided and any applicable increase or decrease in charges.</text> </paragraph> <paragraph num="C."> <text>Charges that incur after the death of the resident may not include services provided to the resident after their death, but may include administrative charges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Service Plan."> <paragraph num="A."> <text>Service Plan Development.</text> <paragraph num="(1)"> <text>The assisted living manager, or designee, shall ensure that all services are provided in a manner that respects and enhances the dignity, privacy, and independence of each resident.</text> </paragraph> <paragraph num="(2)"> <text>A service plan for each resident shall be developed in a manner that enhances the principles of dignity, privacy, resident choice, resident capabilities, individuality, and independence without compromising the health or reasonable safety of other residents.</text> </paragraph> <paragraph num="(3)"> <text>The resident shall be invited to participate in the development of the initial service plan and any subsequent service plans.</text> </paragraph> <paragraph num="(4)"> <text>At the resident’s request, a resident representative, family member, or other individual shall be invited to participate in all service plan meetings.</text> </paragraph> <paragraph num="(5)"> <text>When the resident lacks the capacity to participate, the resident representative, as applicable to their authority, shall be invited to participate in all service plan meetings.</text> </paragraph> <paragraph num="(6)"> <text>The assisted living program shall accommodate the schedules of participants in a service plan meeting when possible.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Assessment of Condition.</text> <paragraph num="(1)"> <text>The resident’s service plan shall be based on an assessment of the resident’s health, function, behavioral, and psychosocial status using the Resident Assessment Tool and the nursing assessment.</text> </paragraph> <paragraph num="(2)"> <text>A full assessment of the resident shall be completed:</text> <paragraph num="(a)"> <text>Within 48 hours but not later than required by nursing practice and the patient’s condition after:</text> <paragraph num="(i)"> <text>A significant change of condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Each nonroutine hospitalization; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>At least annually.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall:</text> <paragraph num="(a)"> <text>Document the determination and the reasons for the determination in the resident’s record; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that a full assessment of the resident is conducted within 7 calendar days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A review of the assessment shall be conducted every 6 months for residents who do not have a change in condition. Further evaluation by a health care practitioner is required and changes shall be made to the resident’s service plan, if there is a score change in any of the following areas:</text> <paragraph num="(a)"> <text>Cognitive and behavioral status;</text> </paragraph> <paragraph num="(b)"> <text>Ability to self-administer medications; and</text> </paragraph> <paragraph num="(c)"> <text>Behaviors and communication.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the resident’s previous assessment did not indicate the need for awake overnight staff, each full assessment or review of the full assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Special Care Needs. The service plan shall reflect increased monitoring, intervention, and oversight, as clinically appropriate for special care needs, including:</text> <paragraph num="(1)"> <text>Fall risk or frequent falls;</text> </paragraph> <paragraph num="(2)"> <text>Pressure ulcer risk, prevention, and treatment;</text> </paragraph> <paragraph num="(3)"> <text>Diabetes management;</text> </paragraph> <paragraph num="(4)"> <text>Oxygen therapy;</text> </paragraph> <paragraph num="(5)"> <text>Enteral feedings;</text> </paragraph> <paragraph num="(6)"> <text>Foley catheter care;</text> </paragraph> <paragraph num="(7)"> <text>Ostomy care;</text> </paragraph> <paragraph num="(8)"> <text>Therapeutic medication levels;</text> </paragraph> <paragraph num="(9)"> <text>Mental illness; and</text> </paragraph> <paragraph num="(10)"> <text>Behaviors that are likely to disrupt or harm the resident or others.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The assisted living manager, or designee, shall ensure that:</text> <paragraph num="(1)"> <text>A written service plan or other documentation sufficiently recorded in the resident’s record is developed by staff, which at a minimum addresses:</text> <paragraph num="(a)"> <text>The services to be provided to the resident, which are based on the assessment of the resident;</text> </paragraph> <paragraph num="(b)"> <text>When and how often the services are to be provided; and</text> </paragraph> <paragraph num="(c)"> <text>How and by whom the services are to be provided;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The service plan is developed within 30 calendar days of admission to the assisted living program; and</text> </paragraph> <paragraph num="(3)"> <text>The service plan is reviewed by staff at least every 6 months, and updated, if needed, unless a resident’s condition or preferences significantly change, in which case the assisted living manager or designee shall review and update the service plan sooner to respond to these changes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Resident Record."> <paragraph num="A."> <text>The assisted living manager shall ensure that an individual record or log is maintained at the assisted living program for each resident in a manner that ensures security and confidentiality, and which includes at a minimum:</text> <paragraph num="(1)"> <text>Resident Assessment Tools;</text> </paragraph> <paragraph num="(2)"> <text>Nursing assessments;</text> </paragraph> <paragraph num="(3)"> <text>Medical orders;</text> </paragraph> <paragraph num="(4)"> <text>Service plans;</text> </paragraph> <paragraph num="(5)"> <text>Care notes;</text> </paragraph> <paragraph num="(6)"> <text>Emergency data sheet;</text> </paragraph> <paragraph num="(7)"> <text>Applicable advance directive and mental health advance directive;</text> </paragraph> <paragraph num="(8)"> <text>Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form;</text> </paragraph> <paragraph num="(9)"> <text>Monthly weights or, in accordance with the health care practitioner’s orders for weights, more or less frequently;</text> </paragraph> <paragraph num="(10)"> <text>Pharmacy reviews, if appropriate;</text> </paragraph> <paragraph num="(11)"> <text>Rehabilitation plans, if appropriate; and</text> </paragraph> <paragraph num="(12)"> <text>Any other records related to the care and services provided to the resident.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Readmission of a Resident.</text> <paragraph num="(1)"> <text>A resident shall be reassessed by the delegating nurse within 48 hours of readmission to the program if the following occurs:</text> <paragraph num="(a)"> <text>Hospitalizations or a 15-day or longer stay in any skilled facility; or</text> </paragraph> <paragraph num="(b)"> <text>There is a significant change in the resident’s mental or physical status upon return to the program after an absence from the program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall:</text> <paragraph num="(a)"> <text>Document the determination and the reasons for the determination in the resident’s record; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that a full assessment of the resident is conducted within 7 calendar days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The assisted living manager shall develop policies and procedures to ensure that all information relating to a resident’s condition or preferences, including any significant change as defined in Regulation .02B(81) of this chapter, is documented in the resident’s record and communicated in a timely manner to:</text> <paragraph num="(1)"> <text>The resident;</text> </paragraph> <paragraph num="(2)"> <text>The resident representative, as appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>Health care practitioners and staff who are involved in the development and implementation of the resident’s service plan, as appropriate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Resident Care Notes.</text> <paragraph num="(1)"> <text>Appropriate staff shall write care notes for each resident:</text> <paragraph num="(a)"> <text>On admission;</text> </paragraph> <paragraph num="(b)"> <text>At least weekly;</text> </paragraph> <paragraph num="(c)"> <text>With any significant changes in the resident’s condition, including when incidents occur and any follow-up action is taken;</text> </paragraph> <paragraph num="(d)"> <text>When the resident is transferred from the facility to another health care facility;</text> </paragraph> <paragraph num="(e)"> <text>On return from medical appointments;</text> </paragraph> <paragraph num="(f)"> <text>When seen in the facility by any health care practitioner or health care provider;</text> </paragraph> <paragraph num="(g)"> <text>On return from nonroutine leaves of absence; and</text> </paragraph> <paragraph num="(h)"> <text>When the resident is discharged permanently from the facility, including the location and manner of discharge.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Staff shall write care notes that are individualized, legible, dated, timed, and signed by the writer.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The assisted living program shall maintain a resident’s record for 5 years after the resident is discharged.</text> </paragraph> <paragraph num="F."> <text>If an assisted living program ceases operation, the assisted living program shall make arrangements to retain records as required by §E of this regulation.</text> </paragraph> <paragraph num="G."> <text>If the assisted living program changes ownership, the prior owner shall provide all written and electronic records of current residents to the new owner in a usable format prior to the issuance of the new license.</text> </paragraph> <paragraph num="H."> <text>An assisted living program shall:</text> <paragraph num="(1)"> <text>Maintain the privacy and confidentiality of a resident’s medical records and medical information;</text> </paragraph> <paragraph num="(2)"> <text>Release medical records or medical information about a resident only with the consent of the resident or resident representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Services."> <paragraph num="A."> <text>Meals.</text> <paragraph num="(1)"> <text>The assisted living manager shall ensure that:</text> <paragraph num="(a)"> <text>A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week;</text> </paragraph> <paragraph num="(b)"> <text>Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident;</text> </paragraph> <paragraph num="(c)"> <text>At a minimum, residents have access to snacks or food supplements between breakfast and lunch, between lunch and dinner, and during the evening hours;</text> </paragraph> <paragraph num="(d)"> <text>All food is prepared in accordance with all State and local sanitation and safe food handling requirements;</text> </paragraph> <paragraph num="(e)"> <text>Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; and</text> </paragraph> <paragraph num="(f)"> <text>Portion sizes are in accordance with orders from a health care practitioner.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall ensure that menus are nutritionally adequate by having a dietitian or nutritionist review the 4-week menu:</text> <paragraph num="(a)"> <text>Prior to initial licensure;</text> </paragraph> <paragraph num="(b)"> <text>If substantive changes beyond accepted food substitutions have been made; and</text> </paragraph> <paragraph num="(c)"> <text>At least every 3 years.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Menus.</text> <paragraph num="(a)"> <text>Menus shall be written at least 1 week in advance.</text> </paragraph> <paragraph num="(b)"> <text>The assisted living program shall post a weekly menu in a conspicuous place that is visible to residents and other interested parties.</text> </paragraph> <paragraph num="(c)"> <text>Menus shall be maintained on file, as served, for 6 months.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Special Diets.</text> <paragraph num="(a)"> <text>The assisted living program staff shall:</text> <paragraph num="(i)"> <text>Prepare or arrange for the provision of special diets as ordered by the resident’s health care practitioner or as needed by the resident’s condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Document special diets in the resident’s record.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the diet is beyond the capability of the assisted living program, the resident or the resident’s health care practitioner shall make other arrangements for the resident’s care, or the assisted living program shall discharge the resident.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Monitoring. The assisted living manager shall ensure that each resident is monitored on a daily basis to ensure that the resident’s service plan is being properly implemented.</text> </paragraph> <paragraph num="C."> <text>Adaptive Equipment and Assistive Devices.</text> <paragraph num="(1)"> <text>The assisted living manager or their designee shall ensure that all adaptive equipment and assistive devices are in proper working order.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living manager or designee shall facilitate the repair or replacement of adaptive equipment and assistive devices, as needed.</text> </paragraph> <paragraph num="(3)"> <text>Assisted living staff shall assist the resident, as needed, to utilize the adaptive equipment and assistive devices.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nursing Services. The assisted living manager, in consultation with the delegating nurse, shall ensure that all nursing services are provided consistent with the Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>Personal Care Services. The assisted living manager shall provide or ensure the provision of all necessary personal care services, including, but not limited to, the range of assistance needed by a resident to complete the activities of daily living as defined in Regulation .02B(2) of this chapter.</text> </paragraph> <paragraph num="F."> <text>Housekeeping Services. The assisted living manager shall ensure that:</text> <paragraph num="(1)"> <text>Housekeeping services are provided; and</text> </paragraph> <paragraph num="(2)"> <text>All areas of the facility are maintained in a clean and orderly condition.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Health Care and Social Services. The assisted living manager is responsible for facilitating access to any appropriate health care and social services for the resident as determined in the resident’s assessment, including, but not limited to:</text> <paragraph num="(1)"> <text>Social work services;</text> </paragraph> <paragraph num="(2)"> <text>Rehabilitative services, including occupational, physical, speech, and audiology therapies;</text> </paragraph> <paragraph num="(3)"> <text>Home health services;</text> </paragraph> <paragraph num="(4)"> <text>Hospice services;</text> </paragraph> <paragraph num="(5)"> <text>Skilled nursing services;</text> </paragraph> <paragraph num="(6)"> <text>Health care practitioner services;</text> </paragraph> <paragraph num="(7)"> <text>Oral health care;</text> </paragraph> <paragraph num="(8)"> <text>Dietary consultation and services;</text> </paragraph> <paragraph num="(9)"> <text>Counseling;</text> </paragraph> <paragraph num="(10)"> <text>Psychiatric services;</text> </paragraph> <paragraph num="(11)"> <text>Psychological services; and</text> </paragraph> <paragraph num="(12)"> <text>Other specialty health services.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Social and Recreational Activities.</text> <paragraph num="(1)"> <text>In accordance with the resident’s service plan, the assisted living program staff shall encourage resident participation in social and recreational activities, including:</text> <paragraph num="(a)"> <text>Providing or arranging for transportation to these activities in accordance with the resident’s service plan; and</text> </paragraph> <paragraph num="(b)"> <text>Assisting a resident with communication, interpersonal, and social skills, including managing difficult behaviors in accordance with the resident’s service plan.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The assisted living manager shall provide or arrange appropriate opportunities for socialization, social interaction, and leisure activities that reflect the resident’s preferences and promote the physical and mental well-being of each resident.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Spiritual Activities.</text> <paragraph num="(1)"> <text>The assisted living manager or designee shall facilitate access to spiritual and religious activities consistent with the preferences and beliefs of the resident.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living manager or designee shall provide or arrange for transportation to spiritual and religious activities in accordance with the resident’s service plan.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Medication Management and Administration."> <paragraph num="A."> <text>All unlicensed staff who will administer medications to residents shall have first completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing to teach the certified medication technician course.</text> </paragraph> <paragraph num="B."> <text>The assisted living manager shall document completion of the medication technician training and certification as a medication technician by the Maryland Board of Nursing per COMAR 10.39.04 in the personnel file or other readily available record of each unlicensed staff member who administers medications.</text> </paragraph> <paragraph num="C."> <text>All medications shall be administered consistent with applicable requirements of COMAR 10.27.11.</text> </paragraph> <paragraph num="D."> <text>Self-Administration of Medication.</text> <paragraph num="(1)"> <text>An assisted living manager shall ensure that the resident’s initial assessment process identifies whether a resident:</text> <paragraph num="(a)"> <text>Is capable of self-administration of medication;</text> </paragraph> <paragraph num="(b)"> <text>Is capable of self-administration of medication, but requires a reminder to take medications or physical assistance with opening and removing medications from the container, or both; or</text> </paragraph> <paragraph num="(c)"> <text>Requires that medications be administered by the assisted living program staff or by a spouse or domestic partner of the resident in accordance with §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a resident who is capable of self-administration or, although capable, requires a reminder or physical assistance, as stated in §D(1)(b) of this regulation, the assisted living manager shall ensure that the resident is reassessed by the delegating nurse quarterly for the ability to safely self-administer medications with or without assistance.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Administration of Medication by a Spouse or Domestic Partner. While residing in the same assisted living program as their spouse or domestic partner, a resident may administer medications to their spouse or domestic partner providing the following documentation is maintained in the resident’s record:</text> <paragraph num="(1)"> <text>An initial assessment by their health care practitioner documenting the resident’s competency and ability to safely administer medications to their spouse or domestic partner;</text> </paragraph> <paragraph num="(2)"> <text>Quarterly assessments by the delegating nurse documenting the resident’s continued ability to safely administer medications to their spouse or domestic partner; and</text> </paragraph> <paragraph num="(3)"> <text>Current signed medical orders.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Medication Regimen Review Upon Admission.</text> <paragraph num="(1)"> <text>The assisted living manager shall consult within 14 calendar days of a resident’s admission with the individuals set forth in §F(2) of this regulation to review a new resident’s medication regime.</text> </paragraph> <paragraph num="(2)"> <text>The medication review may be conducted by a:</text> <paragraph num="(a)"> <text>Health care practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Registered nurse, who may be the delegating nurse; or</text> </paragraph> <paragraph num="(c)"> <text>Licensed pharmacist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The purpose of the medication regimen review required by §F of this regulation is to review with the assisted living manager or designee:</text> <paragraph num="(1)"> <text>A resident’s current medication profile, including all prescription and nonprescription over-the-counter medications and tube feedings;</text> </paragraph> <paragraph num="(2)"> <text>The potential that current medications have to act as a chemical restraint;</text> </paragraph> <paragraph num="(3)"> <text>The potential for any side effects;</text> </paragraph> <paragraph num="(4)"> <text>The potential for adverse drug interactions; and</text> </paragraph> <paragraph num="(5)"> <text>Any medication errors that have occurred since admission.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The assisted living manager, or designee, shall ensure that the medication regimen review required by §F of this regulation is documented in the resident’s records, including any recommendations given by the reviewer.</text> </paragraph> <paragraph num="I."> <text>Pharmacy Review.</text> <paragraph num="(1)"> <text>The assisted living manager shall arrange for a licensed pharmacist to conduct an on-site review of health care practitioner prescriptions, health care practitioner orders, and resident records at least every 6 months for any resident receiving nine or more medications, including over-the-counter and as needed (PRN) medications.</text> </paragraph> <paragraph num="(2)"> <text>The pharmacist’s review shall include, but is not limited to, whether:</text> <paragraph num="(a)"> <text>The assisted living program is in compliance with Board of Pharmacy’s requirements for packaging of medications;</text> </paragraph> <paragraph num="(b)"> <text>Each resident’s medications are properly stored and maintained;</text> </paragraph> <paragraph num="(c)"> <text>Each resident receives the medications that have been specifically prescribed for that resident in the manner that has been ordered;</text> </paragraph> <paragraph num="(d)"> <text>The desired effectiveness of each medication is achieved based on available information, and, if not, that the appropriate authorized prescriber is so informed;</text> </paragraph> <paragraph num="(e)"> <text>Any undesired side effects, potential and actual adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber;</text> </paragraph> <paragraph num="(f)"> <text>The resident has a medical condition as documented in the resident’s records that is not currently being treated by medication;</text> </paragraph> <paragraph num="(g)"> <text>There is medication use without current indication in the resident’s records of a medical condition that warrants the use of the medication;</text> </paragraph> <paragraph num="(h)"> <text>There is medication overuse that is causing side effects as documented in the resident records;</text> </paragraph> <paragraph num="(i)"> <text>Current medication selections result in inappropriate medication dosage;</text> </paragraph> <paragraph num="(j)"> <text>The resident may be experiencing drug interactions;</text> </paragraph> <paragraph num="(k)"> <text>The resident is receiving medication, either prescribed or over-the-counter medications, as well as herbal remedies that could result in drug-drug, drug-food, or drug-laboratory test interactions;</text> </paragraph> <paragraph num="(l)"> <text>Administration times of medication need to be modified to address drug interactions or meal times, or both;</text> </paragraph> <paragraph num="(m)"> <text>Periodic diagnostic monitoring required by certain medications have been performed; and</text> </paragraph> <paragraph num="(n)"> <text>More cost-effective medications are available to treat current medical conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The pharmacist shall document the pharmacy review as required under this section in each resident’s chart and this documentation shall be reviewed every 6 months as part of the assisted living program’s quality assurance activities as required in Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The person conducting the on-site review under §F or G of this regulation shall recommend changes, as appropriate, to the appropriate authorized prescriber and the assisted living manager or designee.</text> </paragraph> <paragraph num="K."> <text>If a resident requires that staff administer medications as defined in Regulation .02B(3) of this chapter, and the administration of medications has been delegated to an unlicensed staff person pursuant to COMAR 10.27.11, the assisted living manager shall comply with COMAR 10.27.11 by arranging for an on-site review by the delegating registered nurse at least every 45 calendar days. The delegating nurse shall make appropriate recommendations to the appropriate authorized prescriber, and the assisted living manager or designee.</text> </paragraph> <paragraph num="L."> <text>Safe Storage of Medication. The assisted living manager, or designee, shall ensure that:</text> <paragraph num="(1)"> <text>Medications are stored in the original dispensed container;</text> </paragraph> <paragraph num="(2)"> <text>Medications are stored in a secure location, at the proper temperature; and</text> </paragraph> <paragraph num="(3)"> <text>The following documentation is maintained for all prescription and over-the-counter medications prescribed to residents:</text> <paragraph num="(a)"> <text>Name of the resident;</text> </paragraph> <paragraph num="(b)"> <text>Name of the medication;</text> </paragraph> <paragraph num="(c)"> <text>Reason for the medication;</text> </paragraph> <paragraph num="(d)"> <text>Dose;</text> </paragraph> <paragraph num="(e)"> <text>Frequency;</text> </paragraph> <paragraph num="(f)"> <text>Route;</text> </paragraph> <paragraph num="(g)"> <text>Authorized prescriber’s name;</text> </paragraph> <paragraph num="(h)"> <text>Date of issuance;</text> </paragraph> <paragraph num="(i)"> <text>Expiration date;</text> </paragraph> <paragraph num="(j)"> <text>Refill limits; and</text> </paragraph> <paragraph num="(k)"> <text>Directions for use.</text> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Medications and treatments shall be administered consistent with current signed medical orders and using professional standards of practice.</text> </paragraph> <paragraph num="N."> <text>Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy.</text> </paragraph> <paragraph num="O."> <text>Required Documentation.</text> <paragraph num="(1)"> <text>A staff member shall record the documentation required under §L of this regulation for all residents for whom medications are administered, or who receive assistance in taking their medications, as defined by Regulation .02B(3)(b) of this chapter, at the time that the resident takes or receives medications.</text> </paragraph> <paragraph num="(2)"> <text>A staff member shall record the documentation required under §L of this regulation for residents who self-administer:</text> <paragraph num="(a)"> <text>Upon admission; or</text> </paragraph> <paragraph num="(b)"> <text>When changes in the resident’s medication regimen are ordered by a health care practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="P."> <text>Accounting for Narcotic and Controlled Substances.</text> <paragraph num="(1)"> <text>A qualified staff member and a witness shall count and record Schedule II through V controlled substances before the close of every shift.</text> </paragraph> <paragraph num="(2)"> <text>The daily record shall account for all controlled substances documented as administered on the medication administration record.</text> </paragraph> <paragraph num="(3)"> <text>All Schedule II through V controlled substances shall be maintained under a double lock system.</text> </paragraph> <paragraph num="(4)"> <text>As required, the assisted living program shall obtain a Controlled Dangerous Substances registration certificate from the Department’s Office of Controlled Substances Administration.</text> </paragraph> <paragraph num="(5)"> <text>The assisted living manager shall develop written policies and procedures to guard against theft and diversion of controlled substances, that include:</text> <paragraph num="(a)"> <text>Proper storage;</text> </paragraph> <paragraph num="(b)"> <text>Accountability;</text> </paragraph> <paragraph num="(c)"> <text>Access;</text> </paragraph> <paragraph num="(d)"> <text>Destruction; and</text> </paragraph> <paragraph num="(e)"> <text>Reporting procedures.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Controlled substances may not be returned to the pharmacy.</text> </paragraph> <paragraph num="(7)"> <text>Controlled substances in need of disposal shall be destroyed on-site at the assisted living program and their destruction shall be:</text> <paragraph num="(a)"> <text>Conducted by two members of the staff, one of whom shall be a licensed practitioner, licensed pharmacist, registered nurse, licensed practical nurse, certified medication technician, or licensed assisted living manager; and</text> </paragraph> <paragraph num="(b)"> <text>Recorded on a form supplied by the Division of Drug Control, a copy of which shall be forwarded to the Division within 10 calendar days of destruction.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Alzheimer’s Special Care Unit."> <paragraph num="A."> <text>Initial Approval of an Alzheimer’s Special Care Unit. An assisted living program requesting the initial approval to operate an Alzheimer’s Special Care Unit shall submit to the Department a written description of the Alzheimer’s Special Care Unit using a disclosure form developed by the Department. The description shall explain how:</text> <paragraph num="(1)"> <text>The form of care and treatment provided by the Alzheimer’s Special Care Unit is specifically designed for the specialized care of individuals diagnosed with Alzheimer’s disease or a related dementias; and</text> </paragraph> <paragraph num="(2)"> <text>The care in the Alzheimer’s Special Care Unit differs from the care and treatment provided in the nonspecial care unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Approval of an Alzheimer’s Special Care Unit.</text> <paragraph num="(1)"> <text>An assisted living program shall have written approval from the Department prior to operating an Alzheimer’s Special Care Unit.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall have written approval from the Department of an Alzheimer's Special Care Unit prior to advertising or marketing the unit.</text> </paragraph> <paragraph num="(3)"> <text>The Department will either approve or not approve the operation of the Alzheimer’s Special Care Unit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Substantive Changes to the Alzheimer’s Special Care Unit.</text> <paragraph num="(1)"> <text>The written description of the Alzheimer’s Special Care Unit shall accurately reflect the current operation of the unit.</text> </paragraph> <paragraph num="(2)"> <text>If any substantive changes are made to the Alzheimer’s Special Care Unit, the revised written description shall be submitted to the Department for review and approval.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall inform the provider of the decision of the review within 30 calendar days from the Department’s receipt of the revised written description.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An assisted living program with an Alzheimer’s Special Care Unit shall disclose the written description of the unit to:</text> <paragraph num="(1)"> <text>Any person on request;</text> </paragraph> <paragraph num="(2)"> <text>The resident, as appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>The family or resident representative before admission of the resident to the Alzheimer’s Special Care Unit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The description of the Alzheimer’s Special Care Unit shall include:</text> <paragraph num="(1)"> <text>A statement of philosophy or mission;</text> </paragraph> <paragraph num="(2)"> <text>How the services of the unit are different from services provided in the rest of the assisted living program;</text> </paragraph> <paragraph num="(3)"> <text>Staff training and staff job titles, including:</text> <paragraph num="(a)"> <text>A description of a minimum of 6 hours of advanced cognitive impairment training for any staff who is licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or any staff whose job duties include providing personal care on the Alzheimer’s Special Care Unit, including:</text> <paragraph num="(i)"> <text>2 hours related to effective communication;</text> </paragraph> <paragraph num="(ii)"> <text>2 hours related to behavioral interventions; and</text> </paragraph> <paragraph num="(iii)"> <text>2 hours related to making activities meaningful; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The number of hours of dementia-specific training provided annually for all staff by job classification and a summary of training content;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Admission procedures, including screening criteria;</text> </paragraph> <paragraph num="(5)"> <text>Assessment and service planning protocol, including criteria to be used that would trigger a reassessment of the resident’s status before the customary 6-month review;</text> </paragraph> <paragraph num="(6)"> <text>Staffing patterns, including:</text> <paragraph num="(a)"> <text>The ratio of direct care staff to resident for a 24-hour cycle;</text> </paragraph> <paragraph num="(b)"> <text>A description of how the staffing pattern differs from that of the rest of the assisted living program; and</text> </paragraph> <paragraph num="(c)"> <text>Use of awake overnight staff on the unit;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A description of the physical environment and any unique design features appropriate to support the functioning of cognitively impaired individuals;</text> </paragraph> <paragraph num="(8)"> <text>A description of activities, including frequency and type, how the activities meet the needs of residents with dementia, and how the activities differ from activities for residents in other parts of the assisted living program;</text> </paragraph> <paragraph num="(9)"> <text>The assisted living program’s fee or fee structure for services provided by the Alzheimer’s Special Care Unit;</text> </paragraph> <paragraph num="(10)"> <text>Discharge criteria and procedures;</text> </paragraph> <paragraph num="(11)"> <text>Any services, training, or other procedures that are over and above those that are provided in the existing assisted living program; and</text> </paragraph> <paragraph num="(12)"> <text>Any other information that the Department may require.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall restrict admission or close the operation of an Alzheimer’s Special Care Unit if the Department determines that the assisted living program has not demonstrated compliance with this regulation or the health or safety of residents is at risk.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Incident Reports."> <paragraph num="A."> <text>Staff of the assisted living program shall complete an incident report within 24 hours of having knowledge that an incident, as defined in Regulation .02B(39) of this chapter, occurred.</text> </paragraph> <paragraph num="B."> <text>The assisted living program shall make incident reports available on the premises to the Department and any government agency designated by the Department.</text> </paragraph> <paragraph num="C."> <text>All incident reports shall include:</text> <paragraph num="(1)"> <text>Time, date, and place;</text> </paragraph> <paragraph num="(2)"> <text>Individuals present;</text> </paragraph> <paragraph num="(3)"> <text>Complete description of the incident;</text> </paragraph> <paragraph num="(4)"> <text>Response of the staff at the time; and</text> </paragraph> <paragraph num="(5)"> <text>Notification to the:</text> <paragraph num="(a)"> <text>Resident or, if appropriate, the resident representative;</text> </paragraph> <paragraph num="(b)"> <text>Resident’s health care practitioner, if appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Delegating nurse;</text> </paragraph> <paragraph num="(d)"> <text>Licensing or law enforcement authorities, when appropriate; and</text> </paragraph> <paragraph num="(e)"> <text>Follow-up activities, including investigation of the occurrence and steps to prevent its reoccurrence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The assisted living program shall notify the OHCQ within 24 hours of a resident death resulting from:</text> <paragraph num="(1)"> <text>Abuse;</text> </paragraph> <paragraph num="(2)"> <text>Neglect;</text> </paragraph> <paragraph num="(3)"> <text>Wandering;</text> </paragraph> <paragraph num="(4)"> <text>Elopement;</text> </paragraph> <paragraph num="(5)"> <text>A medication error;</text> </paragraph> <paragraph num="(6)"> <text>Burns; or</text> </paragraph> <paragraph num="(7)"> <text>Any injury incurred at the assisted living program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Relocation and Discharge."> <paragraph num="A."> <text>Relocation within the Facility.</text> <paragraph num="(1)"> <text>The assisted living program may not relocate a resident within the facility except in accordance with the terms and conditions of the resident agreement.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall notify a resident and the resident representative at least 5 calendar days before a nonemergency relocation within the facility and obtain the consent of the resident or resident representative.</text> </paragraph> <paragraph num="(3)"> <text>An assisted living program shall document in the resident’s record how the requirements of this regulation have been met.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Discharge.</text> <paragraph num="(1)"> <text>Discharge of a resident or transfer to another facility or address without the consent of the resident or the resident representative shall be in accordance with the resident agreement.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall notify a resident or the resident representative within 30 calendar days before a non-emergency discharge.</text> </paragraph> <paragraph num="(3)"> <text>In the event of an emergency, the program shall notify the resident or the resident representative as quickly as possible and document the reason for the emergency and abbreviated notice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The assisted living program shall consider the resident’s specific care needs and preferences in developing a safe and appropriate discharge plan.</text> </paragraph> <paragraph num="D."> <text>When the resident is discharged to another facility, the assisted living program shall provide to the receiving facility any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the:</text> <paragraph num="(1)"> <text>Emergency data sheet;</text> </paragraph> <paragraph num="(2)"> <text>Current medication and treatment orders;</text> </paragraph> <paragraph num="(3)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(4)"> <text>Most current Resident Assessment Tool.</text> </paragraph> </paragraph> <paragraph num="E."> <text>When the resident is discharged to home or to a non-facility setting, the assisted living program shall provide the resident and resident representative any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the:</text> <paragraph num="(1)"> <text>Emergency data sheet;</text> </paragraph> <paragraph num="(2)"> <text>Current medication and treatment orders;</text> </paragraph> <paragraph num="(3)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(4)"> <text>Most current Resident Assessment Tool.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In the event of a health emergency requiring the transfer to an acute care facility, a copy of an emergency data sheet shall accompany the resident to an acute care facility. This data sheet shall, at a minimum, include:</text> <paragraph num="(1)"> <text>The resident’s full name, date of birth, Social Security number, if known, and insurance information;</text> </paragraph> <paragraph num="(2)"> <text>The name, telephone number, and address of the resident representative;</text> </paragraph> <paragraph num="(3)"> <text>The name and telephone number of the resident’s health care practitioner;</text> </paragraph> <paragraph num="(4)"> <text>The resident’s current documented diagnoses;</text> </paragraph> <paragraph num="(5)"> <text>Current medications prescribed for the resident;</text> </paragraph> <paragraph num="(6)"> <text>The resident’s known allergies to food or medications, if any;</text> </paragraph> <paragraph num="(7)"> <text>The resident’s dietary restrictions, if any;</text> </paragraph> <paragraph num="(8)"> <text>Any relevant information concerning the event that precipitated the emergency; and</text> </paragraph> <paragraph num="(9)"> <text>Appended copies of:</text> <paragraph num="(a)"> <text>Advance directives;</text> </paragraph> <paragraph num="(b)"> <text>Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form;</text> </paragraph> <paragraph num="(c)"> <text>Powers of attorney, if any; and</text> </paragraph> <paragraph num="(d)"> <text>Guardianship orders, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Within 30 calendar days of the date of discharge, the assisted living program shall:</text> <paragraph num="(1)"> <text>Give each resident or resident agent:</text> <paragraph num="(a)"> <text>A final statement of account; and</text> </paragraph> <paragraph num="(b)"> <text>Any refunds due; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Return any money, property, or valuables held in trust or custody by the assisted living program.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If requested by a resident, a resident representative, a governmental agency, or, on its own initiative, the Office of the Attorney General may:</text> <paragraph num="(1)"> <text>Investigate whether an abuse of a resident’s funds contributed to the decision to discharge the resident; and</text> </paragraph> <paragraph num="(2)"> <text>Make appropriate referrals of the matter to other government agencies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Resident Representative."> <paragraph num="A."> <text>An assisted living program shall recognize the applicable authority of:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>A power of attorney that meets the requirements under Estates and Trusts Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>A representative payee or other similar fiduciary; and</text> </paragraph> <paragraph num="(7)"> <text>Any other person, if that person was designated by a resident who was competent at the time of designation, and the resident or representative has provided the assisted living program with documentation of the designation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Representative Payee or Other Similar Fiduciary.</text> <paragraph num="(1)"> <text>An assisted living program staff member who serves as a representative payee for a resident may not be considered the resident representative.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall notify the Department if an assisted living program staff member is designated as the representative payee for a resident.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An assisted living program shall document in the resident’s record the name of the person, if any, with the authority identified in §A of this regulation or include the documentation in the record.</text> </paragraph> <paragraph num="D."> <text>An assisted living program may not recognize the authority of a resident representative if the representative attempts to exceed the authority:</text> <paragraph num="(1)"> <text>Stated in the instrument that grants the representative authority; or</text> </paragraph> <paragraph num="(2)"> <text>Established by federal or State law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An assisted living program who commits financial exploitation of a resident shall be in violation of this chapter as well as applicable civil and criminal laws.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Resident’s Rights."> <paragraph num="A."> <text>Resident Bill of Rights.</text> <paragraph num="(1)"> <text>An assisted living program shall develop a Resident Bill of Rights that, at a minimum, includes the following rights:</text> <paragraph num="(a)"> <text>Be treated with consideration, respect, and full recognition of the resident’s human dignity and individuality;</text> </paragraph> <paragraph num="(b)"> <text>Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;</text> </paragraph> <paragraph num="(c)"> <text>Receive services and supports that optimize autonomy, independence, and personal choice;</text> </paragraph> <paragraph num="(d)"> <text>Actively participate in planning and developing the resident’s service plan and medical treatment;</text> </paragraph> <paragraph num="(e)"> <text>Choose a pharmacy provider, if the provider can comply with the assisted living programs’ reasonable policies and procedures for patient safety in medication supply and administration;</text> </paragraph> <paragraph num="(f)"> <text>Make an informed decision to accept or refuse treatment;</text> </paragraph> <paragraph num="(g)"> <text>Privacy, including the right to have a staff member knock on the resident’s door before entering unless the staff member knows that the resident is asleep or there is an emergency situation;</text> </paragraph> <paragraph num="(h)"> <text>Be free from mental, verbal, sexual, and physical abuse, neglect, and financial exploitation;</text> </paragraph> <paragraph num="(i)"> <text>Be free from involuntary seclusion and physical and chemical restraint used in violation of this chapter;</text> </paragraph> <paragraph num="(j)"> <text>Confidentiality;</text> </paragraph> <paragraph num="(k)"> <text>Manage personal financial affairs to the extent permitted by law;</text> </paragraph> <paragraph num="(l)"> <text>Retain and have access to legal counsel in a private setting;</text> </paragraph> <paragraph num="(m)"> <text>Attend or not attend religious services as the resident chooses, and receive visits from members of the clergy;</text> </paragraph> <paragraph num="(n)"> <text>Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the assisted living program’s security policy;</text> </paragraph> <paragraph num="(o)"> <text>Determine dress, hairstyle, or other personal effects according to individual preference, unless the personal hygiene of a resident is compromised;</text> </paragraph> <paragraph num="(p)"> <text>Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions on visiting hours and places:</text> <paragraph num="(i)"> <text>In accordance with the resident agreement; and</text> </paragraph> <paragraph num="(ii)"> <text>As posted by the assisted living manager;</text> </paragraph> </paragraph> <paragraph num="(q)"> <text>Make suggestions or complaints or present grievances on behalf of the resident, or others, to the assisted living manager, government agencies, or other persons without threat or fear of retaliation;</text> </paragraph> <paragraph num="(r)"> <text>Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the resident may have;</text> </paragraph> <paragraph num="(s)"> <text>Have access to the procedures for making complaints to:</text> <paragraph num="(i)"> <text>The Long-Term Care Ombudsman Program of the Department of Aging as set forth in COMAR 32.03.02;</text> </paragraph> <paragraph num="(ii)"> <text>The Adult Protective Services Program of the local department of human services;</text> </paragraph> <paragraph num="(iii)"> <text>The OHCQ of the Department; and</text> </paragraph> <paragraph num="(iv)"> <text>The designated protection and advocacy agency, if applicable;</text> </paragraph> </paragraph> <paragraph num="(t)"> <text>Have access to writing instruments, stationery, and postage;</text> </paragraph> <paragraph num="(u)"> <text>Receive and send correspondence without delay, and without the correspondence being opened, censored, controlled, or restricted, except on request of the resident, or written request of the resident representative;</text> </paragraph> <paragraph num="(v)"> <text>Receive a prompt, reasonable response from an assisted living manager or staff to a personal request of the resident;</text> </paragraph> <paragraph num="(w)"> <text>Receive notice before the resident’s roommate is changed and, to the extent possible, have input into the choice of roommate;</text> </paragraph> <paragraph num="(x)"> <text>Have reasonable access to the private use of a common use telephone within the facility;</text> </paragraph> <paragraph num="(y)"> <text>Retain personal clothing and possessions as space permits with the understanding that the assisted living program may limit the number of personal possessions retained at the facility for the health and safety of other residents;</text> </paragraph> <paragraph num="(z)"> <text>To participate in decision making regarding transitions in care, including a transfer or discharge from a facility; and</text> </paragraph> <paragraph num="(aa)"> <text>To receive notice, procedural fairness, and humane treatment when being transferred or discharged from an assisted living facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall:</text> <paragraph num="(a)"> <text>Provide the Resident Bill of Rights to all residents and resident representatives prior to or upon admission; and</text> </paragraph> <paragraph num="(b)"> <text>Either:</text> <paragraph num="(i)"> <text>Post the Resident Bill of Rights in a conspicuous place that is visible to residents, potential residents, and other interested parties; or</text> </paragraph> <paragraph num="(ii)"> <text>Post a notice stating where in the facility the Resident Bill of Rights is located.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Confidential Information.</text> <paragraph num="(1)"> <text>Any case discussion, disclosure of health information, consultation, examination, or treatment of a resident is:</text> <paragraph num="(a)"> <text>Confidential;</text> </paragraph> <paragraph num="(b)"> <text>To be done discreetly; and</text> </paragraph> <paragraph num="(c)"> <text>Not open to an individual who is not involved directly in the care of the resident, unless the resident or resident representative permits the individual to be present.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as necessary for the transfer of a resident from the assisted living program to another facility, or as otherwise required by law, the personal and medical records of a resident are confidential and may not be released without the consent of the resident or resident representative to any individual who is:</text> <paragraph num="(a)"> <text>Not associated with the assisted living program; or</text> </paragraph> <paragraph num="(b)"> <text>Associated with the assisted living program, but does not have a demonstrated need for the information.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The assisted living manager shall share resident information with the Department as necessary to administer this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Work Duties.</text> <paragraph num="(1)"> <text>A resident may not be assigned to do any work for the assisted living program without the resident’s consent and appropriate compensation, unless the resident declines to be compensated.</text> </paragraph> <paragraph num="(2)"> <text>The resident’s work duties shall be described in the resident’s record.</text> </paragraph> <paragraph num="(3)"> <text>The resident’s declining to be compensated shall be documented in the resident’s record.</text> </paragraph> <paragraph num="(4)"> <text>The resident may, at any time, discontinue the work duties without threat or fear of retaliation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Adult Medical Day Care.</text> <paragraph num="(1)"> <text>Adult day care attendance or attendance at any other structured program shall be voluntary.</text> </paragraph> <paragraph num="(2)"> <text>Adult medical day care availability and policies shall be disclosed in the assisted living program’s resident agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Abuse, Neglect, and Financial Exploitation."> <paragraph num="A."> <text>An assisted living program shall develop and implement policies and procedures prohibiting abuse, neglect, and financial exploitation of residents.</text> </paragraph> <paragraph num="B."> <text>An assisted living program may not knowingly employ an individual who has any criminal conviction or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check.</text> </paragraph> <paragraph num="C."> <text>Reports of Abuse, Neglect, or Financial Exploitation.</text> <paragraph num="(1)"> <text>An assisted living program or employee of an assisted living program who has witnessed, or otherwise has reason to believe, that a resident has been subjected to abuse, neglect, or financial exploitation shall report the alleged abuse, neglect, or financial exploitation within 24 hours to the:</text> <paragraph num="(a)"> <text>Appropriate law enforcement agency;</text> </paragraph> <paragraph num="(b)"> <text>Office of Health Care Quality of the Department;</text> </paragraph> <paragraph num="(c)"> <text>Ombudsman within the Department of Aging or local area agency on aging;</text> </paragraph> <paragraph num="(d)"> <text>Local Department of Human Services or Adult Protective Services; and</text> </paragraph> <paragraph num="(e)"> <text>Assisted living manager unless they are believed to be involved with the abuse, neglect, or financial exploitation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An assisted living program or an employee may be subject to a penalty imposed by the Secretary of up to $1,000 for failing to make a report required by §C(1) of this regulation within 3 days after learning of the alleged abuse, neglect, or financial exploitation.</text> </paragraph> <paragraph num="(3)"> <text>A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>A licensed or certified individual who has knowledge of, but does not report, suspected abuse, neglect, or financial exploitation may be referred to their respective health occupation board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Investigations. An assisted living program shall:</text> <paragraph num="(1)"> <text>Thoroughly investigate all allegations of abuse, neglect, or financial exploitation and maintain on-site written documentation of the investigation; and</text> </paragraph> <paragraph num="(2)"> <text>Take appropriate action to prevent further incidents of abuse, neglect, or financial exploitation while the investigation is in progress.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Investigation Reports.</text> <paragraph num="(1)"> <text>The assisted living program or any government agency that investigates the abuse, neglect, or financial exploitation shall send a report to the:</text> <paragraph num="(a)"> <text>Appropriate law enforcement agency;</text> </paragraph> <paragraph num="(b)"> <text>Office of Health Care Quality of the Department;</text> </paragraph> <paragraph num="(c)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(d)"> <text>Local Department of Human Services or Adult Protective Services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The entities set forth in §E(1) of this regulation may make a referral, if appropriate, to:</text> <paragraph num="(a)"> <text>The State’s attorney’s office; or</text> </paragraph> <paragraph num="(b)"> <text>The Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>Notice. The assisted living program shall post signs that set forth the reporting requirements of §C(1) of this regulation, conspicuously in the employee and public areas of the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Restraints."> <paragraph num="A."> <text>The resident has the right to be free of restraints used in violation of this chapter.</text> </paragraph> <paragraph num="B."> <text>A protective device as defined in Regulation .02B(66) of this chapter is not considered a restraint.</text> </paragraph> <paragraph num="C."> <text>Improper Use of Chemicals or Drugs. Chemicals or drugs may not be used for residents in the following ways:</text> <paragraph num="(1)"> <text>In excessive dose, including duplicate drug therapy;</text> </paragraph> <paragraph num="(2)"> <text>For excessive duration, without adequate monitoring;</text> </paragraph> <paragraph num="(3)"> <text>Without adequate indications for its use; or</text> </paragraph> <paragraph num="(4)"> <text>In the presence of adverse consequences which indicate the dose should be reduced or discontinued.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Improper Use of Physical Restraints. Residents may not be physically restrained:</text> <paragraph num="(1)"> <text>For discipline or convenience; or</text> </paragraph> <paragraph num="(2)"> <text>If a restraint is not ordered by a physician to treat the resident’s symptoms or medical conditions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Restraint Orders.</text> <paragraph num="(1)"> <text>Any restraint shall be ordered by a physician and shall specify:</text> <paragraph num="(a)"> <text>The purpose of the restraint;</text> </paragraph> <paragraph num="(b)"> <text>The type of restraint to be used; and</text> </paragraph> <paragraph num="(c)"> <text>The length of time the restraint shall be used.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A resident may not have an as-needed restraint order.</text> </paragraph> <paragraph num="(3)"> <text>Orders for the use of a restraint shall be time specific.</text> </paragraph> <paragraph num="(4)"> <text>A resident may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity.</text> </paragraph> <paragraph num="(5)"> <text>If an order for the use of a restraint is to be continued, the order shall be renewed at least every 7 calendar days by a physician.</text> </paragraph> <paragraph num="(6)"> <text>The delegating nurse shall provide training to staff in the appropriate use of the restraint ordered by the physician.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Bed Rails. Bed rails may be considered a restraint depending upon the reason for the use of bed rails and how the bed rails are used. This determination is based upon the resident and the effect that bed rails would have upon the resident, as documented in the resident’s record.</text> </paragraph> <paragraph num="G."> <text>The program shall notify the resident’s family or the resident representative each time a restraint is used.</text> </paragraph> <paragraph num="H."> <text>When the resident is under the care of a general hospice care program licensed by the Department and is physically located in an assisted living program licensed by the Department, the general hospice program and the assisted living program shall comply with the requirements of this chapter, COMAR 10.07.21, and federal regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Protection of a Resident’s Personal Funds."> <paragraph num="A."> <text>A resident may:</text> <paragraph num="(1)"> <text>Manage the resident’s financial affairs; or</text> </paragraph> <paragraph num="(2)"> <text>Consistent with State law, choose any individual who is willing and able to handle the resident’s financial affairs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An assisted living program may refuse to handle a resident’s financial affairs.</text> </paragraph> <paragraph num="C."> <text>An assisted living program may not manage a resident’s funds without an express written request from the:</text> <paragraph num="(1)"> <text>Resident; or</text> </paragraph> <paragraph num="(2)"> <text>Resident agent.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Management of Personal Funds. On the written authorization of a resident or resident agent, an assisted living program shall hold, safeguard, manage, and account for the resident’s personal funds as specified in this regulation.</text> </paragraph> <paragraph num="E."> <text>Safeguards Required.</text> <paragraph num="(1)"> <text>Each assisted living program shall develop adequate safeguards to secure the personal funds of a resident that are entrusted to the assisted living program.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program to which $300 or more of a resident’s personal funds is entrusted shall deposit the money in an interest-bearing bank account. If an assisted living program is entrusted with a resident’s personal funds that are less than $300, the assisted living program may deposit the funds in a bank account.</text> </paragraph> <paragraph num="(3)"> <text>An assisted living program that manages residents’ personal funds, regardless of the amount managed, shall maintain on behalf of the residents:</text> <paragraph num="(a)"> <text>A bond, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility;</text> </paragraph> <paragraph num="(b)"> <text>A letter of credit, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility; or</text> </paragraph> <paragraph num="(c)"> <text>Net assets equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The bond, letter of credit, or list of assets shall be kept at the assisted living program for inspection by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Establishment of Resident Accounts.</text> <paragraph num="(1)"> <text>When an assisted living program manages a resident’s financial affairs, the assisted living program shall:</text> <paragraph num="(a)"> <text>Establish and maintain a system that ensures a full, complete, and separate accounting, in accordance with generally accepted accounting principles, of a resident’s personal funds entrusted to the assisted living program; and</text> </paragraph> <paragraph num="(b)"> <text>Keep the accounts of its residents separate from the accounts of the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Bank accounts opened for residents’ personal funds by an assisted living program shall have minimal or no fees.</text> </paragraph> <paragraph num="(3)"> <text>Any interest earned on the bank accounts shall accrue to the resident.</text> </paragraph> <paragraph num="(4)"> <text>Any fees charged by the bank for the maintenance of the account shall be paid by the resident.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Records of Resident Personal Funds. For all resident funds entrusted to an assisted living program, the assisted living program shall:</text> <paragraph num="(1)"> <text>Maintain an individual record for each resident, which includes the following information for each transaction:</text> <paragraph num="(a)"> <text>The date of the transaction;</text> </paragraph> <paragraph num="(b)"> <text>The type of transaction, that is, whether it is a deposit, withdrawal, or any other transaction; and</text> </paragraph> <paragraph num="(c)"> <text>The balance of funds after the completion of the transaction;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Make available for inspection by the resident, or, when applicable, the resident agent or resident representative, a statement of the resident’s account; and</text> </paragraph> <paragraph num="(3)"> <text>Make available at the assisted living program, for audit by the Department or its designee, records pertaining to each resident’s personal funds, including the written authorization required by §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Fire and Theft Coverage. For all resident funds entrusted to an assisted living program, the assisted living program shall establish and maintain adequate fire and theft coverage to protect a resident’s funds that are on the premises of the assisted living program.</text> </paragraph> <paragraph num="I."> <text>Availability of Personal Funds.</text> <paragraph num="(1)"> <text>A resident or, if applicable, the resident’s legally authorized representative, has the right to access funds entrusted to the assisted living program:</text> <paragraph num="(a)"> <text>During normal business hours, if the funds are held within the facility; or</text> </paragraph> <paragraph num="(b)"> <text>Within 3 banking days, if a bank, the State, or a county or municipal treasurer holds the money.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an assisted living program transfers or discharges a resident, the assisted living program shall:</text> <paragraph num="(a)"> <text>Request and follow the resident’s written instructions for transferring the resident’s funds;</text> </paragraph> <paragraph num="(b)"> <text>Return, upon the resident’s or, when applicable, the resident agent’s demand, the resident’s money that the assisted living program has in its possession and have the resident or resident agent sign a receipt for the money; or</text> </paragraph> <paragraph num="(c)"> <text>Make available to the resident or the resident agent, within 3 banking days, the resident’s money which is held in an account with a bank, the State, or a county or municipal treasurer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Ownership Change.</text> <paragraph num="(1)"> <text>If the ownership of an assisted living program changes, the previous owner, with the approval of each resident, shall give the new owner a certified written audit of all funds that residents have entrusted to the assisted living program.</text> </paragraph> <paragraph num="(2)"> <text>The new owner shall give to the previous owner a signed receipt acknowledging the receipt of the accounts.</text> </paragraph> <paragraph num="(3)"> <text>The new owner shall comply with the safeguard requirements of §E of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>If the resident wants the new owner to hold, safeguard, manage, or account for the residents personal funds, then a new written authorization in compliance with §D of this regulation shall be executed.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Resident Liability. A resident is not liable for any act or omission of the assisted living program concerning the finances of the assisted living program or the resident.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Misuse of Resident’s Funds."> <paragraph num="A."> <text>A person may not misappropriate a resident’s assets or income, including spending the resident’s assets or income against or without the consent of the resident or, if the resident is unable to consent, the resident agent.</text> </paragraph> <paragraph num="B."> <text>An individual who witnessed, or otherwise has reason to believe, that there has been an abuse of a resident’s funds shall make a complaint within 24 hours to the:</text> <paragraph num="(1)"> <text>Appropriate law enforcement agency;</text> </paragraph> <paragraph num="(2)"> <text>Office of Health Care Quality of the Department;</text> </paragraph> <paragraph num="(3)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(4)"> <text>Local Department of Human Services or Adult Protective Services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The agency that investigates the abuse of a resident’s funds shall send a report to any other agency listed under §B of this regulation that participates in the licensure or subsidizes the care of the resident. Any agency may make a referral to the State’s Attorney’s Office, or to the Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General, if appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Approval of Burial Arrangements for Unclaimed Deceased Residents."> <paragraph num="A."> <text>An assisted living program shall ascertain and document on admission of the resident, or within 14 calendar days of admission, any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to:</text> <paragraph num="(1)"> <text>Financial;</text> </paragraph> <paragraph num="(2)"> <text>Religious;</text> </paragraph> <paragraph num="(3)"> <text>Name of preferred funeral director, if any; and</text> </paragraph> <paragraph num="(4)"> <text>The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notification on Death. On the death of an individual who appears to be an unclaimed deceased resident, the assisted living manager or designee shall contact any person who, although not having been identified in advance as being responsible for the burial arrangements, might nevertheless at the time of death be willing to claim the body and assume responsibility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="General Physical Plant Requirements."> <paragraph num="A."> <text>The facility and exterior grounds, shall be kept:</text> <paragraph num="(1)"> <text>In good repair;</text> </paragraph> <paragraph num="(2)"> <text>Clean;</text> </paragraph> <paragraph num="(3)"> <text>Free of any object, material, or condition that may create a health hazard, accident, or fire;</text> </paragraph> <paragraph num="(4)"> <text>Free of any object, material, or condition that may create a public nuisance; and</text> </paragraph> <paragraph num="(5)"> <text>Free of insects and rodents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Bathtubs, shower stalls, and lavatories may not be used by the staff for laundering or storing soiled linens.</text> </paragraph> <paragraph num="C."> <text>The assisted living program shall provide in the resident’s room adequate storage space for excess supplies, some personal possessions of residents, and similar items which is:</text> <paragraph num="(1)"> <text>Protected from the elements; and</text> </paragraph> <paragraph num="(2)"> <text>Secure, fixed, and locked in a manner that the resident can access without assistance or with that level of assistance normally required and readily available upon request.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Residents may possess their own cleaning supplies and personal hygiene items if the assisted living manager and delegating nurse have determined that the products would not present a threat to the safety of the resident or others and this decision is documented in the records. The cleaning supplies and personal hygiene items shall be kept in the resident’s room and out of view of other residents when the materials are not in use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".43" heading="Water Supply."> <paragraph num="A."> <text>Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the program is located or a private certified vendor to be submitted with an initial licensure application.</text> </paragraph> <paragraph num="B."> <text>Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility.</text> </paragraph> <paragraph num="C."> <text>Hot Water Temperature. Hot water accessible to residents shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120°F and a minimum temperature of 100°F at the fixture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".44" heading="Sewage Disposal."> <text>The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located.</text> </regulation> <regulation prefix="Regulation" num=".45" heading="Security."> <paragraph num="A."> <text>The facility shall provide:</text> <paragraph num="(1)"> <text>Lockable exterior doors and windows; and</text> </paragraph> <paragraph num="(2)"> <text>An effective automated device or system to alert staff to individuals entering or leaving the building.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A facility need not use an automated alert for an exit door when the exit is staffed by a receptionist or other staff member who views and maintains a log of individuals entering and leaving the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".46" heading="Assist Rails."> <paragraph num="A."> <text>An assisted living program shall provide assist rails in stairways used by residents and for all toilets, showers, and bathtubs used by residents unless, through a waiver request, the Department determines that the physical abilities of the residents make these devices unnecessary for resident safety.</text> </paragraph> <paragraph num="B."> <text>An assisted living program with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by residents.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".47" heading="Emergency Preparedness."> <paragraph num="A."> <text>The facility shall comply with:</text> <paragraph num="(1)"> <text>All applicable local fire and building codes; and</text> </paragraph> <paragraph num="(2)"> <text>The National Fire Protection Association (NFPA) 101 Life Safety Code, including Chapter 24 of NFPA 101 if the facility is a one or two family dwelling as defined by NFPA 101.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fire Extinguishers. An assisted living program shall:</text> <paragraph num="(1)"> <text>Ensure that fire extinguishers are:</text> <paragraph num="(a)"> <text>Located on each floor and adjacent to, or in, special hazard areas, such as:</text> <paragraph num="(i)"> <text>Furnace rooms;</text> </paragraph> <paragraph num="(ii)"> <text>Boiler rooms;</text> </paragraph> <paragraph num="(iii)"> <text>Kitchens; or</text> </paragraph> <paragraph num="(iv)"> <text>Laundries;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Of standard and approved types;</text> </paragraph> <paragraph num="(c)"> <text>Installed and maintained to be conveniently available for use at all times; and</text> </paragraph> <paragraph num="(d)"> <text>Serviced annually, as evidenced by documentation maintained on-site, by an individual or company licensed by the Maryland State Fire Marshall; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Initially and at least annually instruct staff in the use of fire extinguishers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency and Disaster Plan.</text> <paragraph num="(1)"> <text>The assisted living program shall develop an Assisted Living Emergency Preparedness Packet in compliance with the requirements of §C(2)—(11) of this regulation, which shall be readily available to all staff.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including:</text> <paragraph num="(a)"> <text>Evacuation, transportation, or sheltering in-place of residents;</text> </paragraph> <paragraph num="(b)"> <text>Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents;</text> </paragraph> <paragraph num="(c)"> <text>Staff coverage, organization, and assignment of responsibilities for ongoing sheltering in-place or evacuation, including identification of staff members available to report to work or remain for extended periods; and</text> </paragraph> <paragraph num="(d)"> <text>The continuity of services, including:</text> <paragraph num="(i)"> <text>Operations, planning, financial, and logistical arrangements;</text> </paragraph> <paragraph num="(ii)"> <text>Procuring essential goods, equipment, and services to sustain operations for at least 72 hours;</text> </paragraph> <paragraph num="(iii)"> <text>Relocation to alternate facilities or other locations; and</text> </paragraph> <paragraph num="(iv)"> <text>Reasonable efforts to continue care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The assisted living program shall have a tracking system to locate and identify residents in the event of displacement, an emergency, or a disaster that includes at a minimum the:</text> <paragraph num="(a)"> <text>Resident’s name;</text> </paragraph> <paragraph num="(b)"> <text>Date and time that the resident was sent to the initial alternative facility or location;</text> </paragraph> <paragraph num="(c)"> <text>Name of the initial alternative facility or location where the resident was sent; and</text> </paragraph> <paragraph num="(d)"> <text>Contact person and phone number for the facility where the resident was sent.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When the assisted living program relocates residents, the assisted living program shall send a brief medical fact sheet with each resident that includes at a minimum the resident’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Medical condition or diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Medications;</text> </paragraph> <paragraph num="(d)"> <text>Allergies;</text> </paragraph> <paragraph num="(e)"> <text>Special diets or dietary restrictions; and</text> </paragraph> <paragraph num="(f)"> <text>Family or legal representative contact information.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The brief medical fact sheet for each resident described in §C(4) of this regulation shall be:</text> <paragraph num="(a)"> <text>Updated upon the occurrence of change in any of the required information;</text> </paragraph> <paragraph num="(b)"> <text>Reviewed at least monthly; and</text> </paragraph> <paragraph num="(c)"> <text>Maintained in a central location readily accessible and available to accompany residents in case of an emergency evacuation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The assisted living program shall review the emergency and disaster plan at least annually and update the plan as necessary.</text> </paragraph> <paragraph num="(7)"> <text>The assisted living program shall:</text> <paragraph num="(a)"> <text>Identify a facility, facilities, or an alternate location or locations that have agreed to house the licensee’s residents during an emergency evacuation; and</text> </paragraph> <paragraph num="(b)"> <text>Document an agreement with each facility or location.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The assisted living program shall:</text> <paragraph num="(a)"> <text>Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and</text> </paragraph> <paragraph num="(b)"> <text>Document an agreement with each transportation source.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Upon request, an assisted living program shall provide a copy of the facility’s emergency and disaster plan to the local emergency management organization for the purpose of coordinating local emergency planning. The assisted living program shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization.</text> </paragraph> <paragraph num="(10)"> <text>The assisted living program shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison’s contact information to the local emergency management organization.</text> </paragraph> <paragraph num="(11)"> <text>The assisted living program shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The executive summary shall, at a minimum:</text> <paragraph num="(a)"> <text>List means of potential transportation to be used in the event of evacuation;</text> </paragraph> <paragraph num="(b)"> <text>List potential alternative facilities or locations to be used in the event of evacuation;</text> </paragraph> <paragraph num="(c)"> <text>Describe means of communication with family members and legal representatives;</text> </paragraph> <paragraph num="(d)"> <text>Describe the role of the resident, family member, or legal representative in the event of an emergency situation; and</text> </paragraph> <paragraph num="(e)"> <text>Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Evacuation Plans. The facility shall:</text> <paragraph num="(1)"> <text>Conspicuously post individual floor plans with designated evacuation routes on each floor; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that all staff have access to the entire emergency preparedness plan.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Orientation and Drills.</text> <paragraph num="(1)"> <text>The assisted living program shall:</text> <paragraph num="(a)"> <text>Orient staff to the emergency and disaster plan and to their individual responsibilities within 24 hours of the commencement of job duties; and</text> </paragraph> <paragraph num="(b)"> <text>Document completion of the orientation in the staff member’s personnel file through the signature of the employee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fire Drills.</text> <paragraph num="(a)"> <text>The assisted living program shall conduct fire drills at least quarterly on all shifts.</text> </paragraph> <paragraph num="(b)"> <text>Documentation and Retention. The assisted living program shall document and maintain on file for a minimum of 2 years the:</text> <paragraph num="(i)"> <text>Completion date and time of each drill;</text> </paragraph> <paragraph num="(ii)"> <text>Names and signatures of staff who participated in the drill;</text> </paragraph> <paragraph num="(iii)"> <text>Fire scenario used in the drill;</text> </paragraph> <paragraph num="(iv)"> <text>Steps taken by staff during the drill;</text> </paragraph> <paragraph num="(v)"> <text>Successful and non-successful actions taken by staff during the drill; and</text> </paragraph> <paragraph num="(vi)"> <text>Opportunities for improvement identified as a result of the drill.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Semiannual Disaster Drill.</text> <paragraph num="(a)"> <text>The assisted living program shall conduct a semiannual emergency and disaster drill on all shifts during which it practices evacuating residents or sheltering in-place so that each is practiced at least one time a year.</text> </paragraph> <paragraph num="(b)"> <text>The drills may be conducted via a table-top exercise if the program can demonstrate that moving residents will be harmful to the residents.</text> </paragraph> <paragraph num="(c)"> <text>The assisted living program shall document and keep on file for a minimum of 2 years the:</text> <paragraph num="(i)"> <text>Completion date and time of each disaster drill or training session;</text> </paragraph> <paragraph num="(ii)"> <text>Names and signature of staff who participated in the drill or training;</text> </paragraph> <paragraph num="(iii)"> <text>Type of disaster utilized for the drill or training;</text> </paragraph> <paragraph num="(iv)"> <text>Type of drill or training undertaken;</text> </paragraph> <paragraph num="(v)"> <text>Steps taken or discussed by staff during the drill or training;</text> </paragraph> <paragraph num="(vi)"> <text>Successful and non-successful actions taken or discussed by staff during the drill or training; and</text> </paragraph> <paragraph num="(vii)"> <text>Opportunities for improvement as identified as a result of the drill.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The assisted living program shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Emergency Electrical Power Generator.</text> <paragraph num="(1)"> <text>Generator Required. By October 1, 2009, an assisted living program with 50 or more residents shall have an emergency electrical power generator on the premises, unless the program meets the requirements of §F(7) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall:</text> <paragraph num="(a)"> <text>Be activated immediately when normal electrical service fails to operate;</text> </paragraph> <paragraph num="(b)"> <text>Come to full speed and load acceptance within 10 seconds; and</text> </paragraph> <paragraph num="(c)"> <text>Have the capability of 48 hours of operation of the systems listed in §F(5) of this regulation from fuel stored on-site.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Test of Emergency Power System.</text> <paragraph num="(a)"> <text>The program shall test the emergency power system once each month.</text> </paragraph> <paragraph num="(b)"> <text>During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load.</text> </paragraph> <paragraph num="(c)"> <text>Results of the test shall be recorded in a permanent log book that is maintained for that purpose.</text> </paragraph> <paragraph num="(d)"> <text>The assisted living program shall monitor the fuel level of the emergency generator after each test.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The emergency power system shall provide lighting in the following areas of the facility:</text> <paragraph num="(a)"> <text>Areas of egress and protection as required by the State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission;</text> </paragraph> <paragraph num="(b)"> <text>Nurses’ station;</text> </paragraph> <paragraph num="(c)"> <text>Medication distribution station or unit dose storage;</text> </paragraph> <paragraph num="(d)"> <text>An area for emergency telephone use;</text> </paragraph> <paragraph num="(e)"> <text>Boiler or mechanical room;</text> </paragraph> <paragraph num="(f)"> <text>Kitchen;</text> </paragraph> <paragraph num="(g)"> <text>Emergency generator location and switch gear location;</text> </paragraph> <paragraph num="(h)"> <text>Elevator, if operable on emergency power;</text> </paragraph> <paragraph num="(i)"> <text>Areas where life support equipment is used;</text> </paragraph> <paragraph num="(j)"> <text>If applicable, common areas or areas of refuge; and</text> </paragraph> <paragraph num="(k)"> <text>If applicable, toilet rooms of common areas or areas of refuge.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Emergency electrical power shall be provided for the following:</text> <paragraph num="(a)"> <text>Nurses’ call system;</text> </paragraph> <paragraph num="(b)"> <text>At least one telephone in order to make and receive calls;</text> </paragraph> <paragraph num="(c)"> <text>Fire pump;</text> </paragraph> <paragraph num="(d)"> <text>Well pump;</text> </paragraph> <paragraph num="(e)"> <text>Sewerage pump and sump pump;</text> </paragraph> <paragraph num="(f)"> <text>If required for evacuation purposes, an elevator;</text> </paragraph> <paragraph num="(g)"> <text>If necessary, heating equipment needed to maintain a minimum temperature of 70°F (24°C) in all common areas or areas of refuge;</text> </paragraph> <paragraph num="(h)"> <text>Life support equipment; and</text> </paragraph> <paragraph num="(i)"> <text>Nonflammable medical gas systems.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all resident rooms and toilet rooms, the program shall provide common areas or areas of refuge for all residents. The areas shall meet the following requirements:</text> <paragraph num="(a)"> <text>The common area or areas of refuge shall maintain a minimum temperature of 70°F (24°C);</text> </paragraph> <paragraph num="(b)"> <text>Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge; and</text> </paragraph> <paragraph num="(c)"> <text>The program facility shall provide to the Department a written plan that defines the:</text> <paragraph num="(i)"> <text>Specified common areas or areas of refuge;</text> </paragraph> <paragraph num="(ii)"> <text>Paths of egress from the common areas or areas of refuge; and</text> </paragraph> <paragraph num="(iii)"> <text>Provision for light, heat, food service, and washing and toileting of residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Applicability of Emergency Power Requirements.</text> <paragraph num="(a)"> <text>An assisted living program shall be exempt from the requirements of this section if the program can safely transfer residents through an enclosed corridor to a building that is equipped with an electrical power generator that satisfies the requirements of §E of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>An assisted living program may request a waiver from the requirements of this section in accordance with the procedures outlined in COMAR 10.07.14.09 on a year-to-year basis. The program shall demonstrate in the waiver request financial hardship that would create an undue financial burden on the facility and will require the facility to cease operation of the assisted living program.</text> </paragraph> <paragraph num="(c)"> <text>When the Department grants a waiver to an assisted living program for the requirements of this section, the assisted living program shall:</text> <paragraph num="(i)"> <text>Disclose in writing to current and prospective residents that the program does not have an emergency generator; and</text> </paragraph> <paragraph num="(ii)"> <text>Develop a plan to follow in the event of a loss of electrical power.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".48" heading="Smoking."> <paragraph num="A."> <text>The assisted living program shall have a written smoking policy that indicates whether or not the program permits smoking.</text> </paragraph> <paragraph num="B."> <text>When smoking is permitted, the assisted living program shall:</text> <paragraph num="(1)"> <text>Establish smoking policies and procedures which are designed to minimize the risk of fire;</text> </paragraph> <paragraph num="(2)"> <text>Provide in the policies and procedures at least the following:</text> <paragraph num="(a)"> <text>Prohibit smoking in any hazardous location and in any room or compartment where flammable liquids, combustible gases, or oxygen are used or stored;</text> </paragraph> <paragraph num="(b)"> <text>Designate smoking areas; and</text> </paragraph> <paragraph num="(c)"> <text>Provide the smoking areas with ash trays of noncombustible material and safe design;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide smoking areas that comply with all applicable, local, State, and federal regulations;</text> </paragraph> <paragraph num="(4)"> <text>Assess each resident who smokes to determine if assistance or supervision is needed and document the assessment in the resident’s service plan; and</text> </paragraph> <paragraph num="(5)"> <text>At least annually or after a change of condition that may impact a resident’s ability to smoke, reassess a resident who smokes to determine if assistance or supervision is needed and document the reassessment in the resident’s service plan.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".49" heading="Common Use Areas."> <paragraph num="A."> <text>Multipurpose Space.</text> <paragraph num="(1)"> <text>The assisted living program shall provide at least 35 square feet of usable multipurpose floor space per licensed bed. Multipurpose space includes:</text> <paragraph num="(a)"> <text>Dining;</text> </paragraph> <paragraph num="(b)"> <text>Living; and</text> </paragraph> <paragraph num="(c)"> <text>Indoor recreational space.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Usable floor space in a facility does not include:</text> <paragraph num="(a)"> <text>Service areas;</text> </paragraph> <paragraph num="(b)"> <text>Administrative offices;</text> </paragraph> <paragraph num="(c)"> <text>Entrance ways;</text> </paragraph> <paragraph num="(d)"> <text>Closets;</text> </paragraph> <paragraph num="(e)"> <text>Lockers;</text> </paragraph> <paragraph num="(f)"> <text>Wardrobes;</text> </paragraph> <paragraph num="(g)"> <text>Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or</text> </paragraph> <paragraph num="(h)"> <text>Corridors.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The assisted living program may not restrict residents from any area constituting multipurpose space unless a comparable multipurpose space is available for resident use.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Living Room.</text> <paragraph num="(1)"> <text>The assisted living program shall make at least one living room available for resident use.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall ensure that the living rooms are:</text> <paragraph num="(a)"> <text>Well lit and ventilated;</text> </paragraph> <paragraph num="(b)"> <text>Easily accessible; and</text> </paragraph> <paragraph num="(c)"> <text>Furnished with a sufficient number of reading lamps, tables, chairs, or sofas based on residents’ needs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Outdoor Space. An assisted living program shall:</text> <paragraph num="(1)"> <text>Provide or arrange for outside activity space;</text> </paragraph> <paragraph num="(2)"> <text>Adequately light outside activity space during all times residents have access to the space; and</text> </paragraph> <paragraph num="(3)"> <text>Provide the necessary security and supervision of the outside activity space sufficient to meet the needs of the residents.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Public Toilets.</text> <paragraph num="(1)"> <text>An assisted living program with a licensed capacity of 17 or more beds shall provide public restrooms that are:</text> <paragraph num="(a)"> <text>Sufficient in number, and appropriately located, to serve both residents and visitors; and</text> </paragraph> <paragraph num="(b)"> <text>Located close enough to activity areas to allow all residents to participate comfortably in activities and social opportunities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The public toilet is not calculated in the ratio required by Regulation .50A of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Dining Room. An assisted living program shall provide a well lit, adequately ventilated, and appropriately furnished dining area.</text> </paragraph> <paragraph num="F."> <text>Kitchen.</text> <paragraph num="(1)"> <text>An assisted living program shall have a kitchen that has adequate:</text> <paragraph num="(a)"> <text>Storage, refrigerator, and freezer space for perishable and nonperishable foods;</text> </paragraph> <paragraph num="(b)"> <text>Food preparation area or areas with cleanable surfaces;</text> </paragraph> <paragraph num="(c)"> <text>Equipment to deliver foods at safe and palatable temperatures;</text> </paragraph> <paragraph num="(d)"> <text>Space and equipment to wash, sanitize, and store utensils;</text> </paragraph> <paragraph num="(e)"> <text>Space to store and clean garbage cans either within or outside the kitchen;</text> </paragraph> <paragraph num="(f)"> <text>Ice-making capabilities;</text> </paragraph> <paragraph num="(g)"> <text>Equipment for the preparation of food, unless all food service is catered; and</text> </paragraph> <paragraph num="(h)"> <text>Equipment for serving and distributing food to residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An assisted living program with a licensed capacity of 17 or more beds shall comply with the food service facility regulations in COMAR 10.15.03.</text> </paragraph> <paragraph num="(3)"> <text>An assisted living program with fewer than 17 residents is not required to comply with COMAR 10.15.03 unless required to comply by its local jurisdiction or the Department determines and directs that a program shall comply with particular provisions of COMAR 10.15.03 in order to minimize health risks to its residents.</text> </paragraph> <paragraph num="(4)"> <text>An assisted living program with fewer than 17 residents:</text> <paragraph num="(a)"> <text>Shall obtain food from sources that comply with all laws and regulations relating to food, food processing, food handling, and food labeling;</text> </paragraph> <paragraph num="(b)"> <text>Shall protect food from contamination while being stored, prepared, displayed, served, or transported;</text> </paragraph> <paragraph num="(c)"> <text>Shall promptly discard the following:</text> <paragraph num="(i)"> <text>Spoiled food;</text> </paragraph> <paragraph num="(ii)"> <text>Swelled, rusty, or leaky canned foods; and</text> </paragraph> <paragraph num="(iii)"> <text>Food exposed to fire, smoke, or water damage;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>May not serve to residents home-canned food or food in a hermetically sealed container as defined in COMAR 10.15.03.02B, which was prepared in a place other than a licensed food processing establishment;</text> </paragraph> <paragraph num="(e)"> <text>Shall maintain potentially hazardous food as defined in COMAR 10.15.03.02B at 45°F or below, or 140°F or above, until served to residents;</text> </paragraph> <paragraph num="(f)"> <text>Shall maintain food equipment, appliances, and utensils in a clean and sanitary manner and in good repair;</text> </paragraph> <paragraph num="(g)"> <text>Shall maintain food contact surfaces smooth and free of breaks, open seams, cracks, chips, and pits;</text> </paragraph> <paragraph num="(h)"> <text>Shall maintain floors, walls, and storage areas in a clean and sanitary manner and in good repair;</text> </paragraph> <paragraph num="(i)"> <text>Shall provide refrigeration operated at or below 45°F and equipped with an indicating thermometer graduated at 2°F intervals; and</text> </paragraph> <paragraph num="(j)"> <text>Shall provide freezer space operated at 0°F or less and equipped with an indicating thermometer graduated at 2°F intervals.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".50" heading="Resident’s Room and Furnishings."> <paragraph num="A."> <text>Resident Room.</text> <paragraph num="(1)"> <text>More than two residents may not share a resident room.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall provide at least 80 square feet of functional space for single occupancy resident rooms and 120 square feet of functional space for double occupancy resident rooms.</text> </paragraph> <paragraph num="(3)"> <text>Functional space in a resident room does not include the floor area of:</text> <paragraph num="(a)"> <text>Toilet rooms and bathing facilities;</text> </paragraph> <paragraph num="(b)"> <text>Closets, wardrobes, bureaus, or lockers;</text> </paragraph> <paragraph num="(c)"> <text>Entrance vestibules; or</text> </paragraph> <paragraph num="(d)"> <text>The arc of any door, excluding closet doors, that opens into the room.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A room may not be used as a resident room if:</text> <paragraph num="(a)"> <text>The only access to the room is through a bathroom or other resident room; or</text> </paragraph> <paragraph num="(b)"> <text>In order to move from the room to a living room or dining room a person must first go outdoors.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For a program with a licensed capacity of 17 or more beds, a room may not be used as a resident room if in order to move from the room to a living room or dining room, an individual is required to first pass through a kitchen.</text> </paragraph> <paragraph num="(6)"> <text>Resident rooms shall be for the private use of the assigned resident or residents. A resident’s room shall have a latching door and may have a lock on the resident room side of the door at the licensee’s option.</text> </paragraph> <paragraph num="(7)"> <text>If a resident in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the assisted living program shall furnish them.</text> </paragraph> <paragraph num="(8)"> <text>A resident shall have access to a mirror either in the resident’s room or in the resident’s private bathroom, unless a health care practitioner documents in the resident’s record that access to a mirror would be detrimental to the health of the resident.</text> </paragraph> <paragraph num="(9)"> <text>A resident’s room shall have window shades or their equivalent.</text> </paragraph> <paragraph num="(10)"> <text>The assisted living program shall provide adequate closet or wardrobe space, conveniently located to allow each resident to keep personal clothing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Furnishings. Unless a resident brings personal furnishings, or as otherwise specified in the resident agreement, the assisted living program shall provide the following to each resident:</text> <paragraph num="(1)"> <text>A bed, which may not be a rollaway, cot, or folding bed, but shall:</text> <paragraph num="(a)"> <text>Be at least 36 inches wide;</text> </paragraph> <paragraph num="(b)"> <text>Be in good repair;</text> </paragraph> <paragraph num="(c)"> <text>Meet the resident’s medical needs; and</text> </paragraph> <paragraph num="(d)"> <text>Include:</text> <paragraph num="(i)"> <text>A clean mattress sized to fit the bed frame; and</text> </paragraph> <paragraph num="(ii)"> <text>At least two clean pillows;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A bedside stand with a drawer;</text> </paragraph> <paragraph num="(3)"> <text>A chair;</text> </paragraph> <paragraph num="(4)"> <text>At least two dresser drawers in a chest of drawers;</text> </paragraph> <paragraph num="(5)"> <text>A bedside or over-the-bed lamp; and</text> </paragraph> <paragraph num="(6)"> <text>A sufficient supply of bath and bed linens.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A competent resident may waive the resident’s right to one or all of the furnishings listed in §B of this regulation by signing a waiver and having the waiver placed in the resident’s record.</text> </paragraph> <paragraph num="D."> <text>The assisted living program shall inform a resident of all of the furnishings that the assisted living program provides. The resident may choose, at their cost, to provide a personal bed or other furnishings if they are not hazardous.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".51" heading="Bathrooms for Residents."> <paragraph num="A."> <text>Toilets.</text> <paragraph num="(1)"> <text>An assisted living program shall provide toilets in a separate room or compartment with latching hardware for privacy.</text> </paragraph> <paragraph num="(2)"> <text>Buildings with one to eight occupants shall have a minimum ratio of one toilet to four occupants.</text> </paragraph> <paragraph num="(3)"> <text>Buildings with nine or more occupants shall have a minimum ratio of one toilet to four occupants and a minimum of one toilet for each floor on which a resident room is located.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hand Sinks.</text> <paragraph num="(1)"> <text>Buildings with one to eight occupants shall have a minimum ratio of one hand sink to four occupants.</text> </paragraph> <paragraph num="(2)"> <text>Buildings with nine or more occupants shall have a minimum ratio of one hand sink to four occupants and a minimum of one hand sink for each floor on which a resident room is located.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Bathtubs or Showers. An assisted living program shall:</text> <paragraph num="(1)"> <text>Provide residents with bathtubs or showers that are enclosed in a separate room or compartment with latching hardware for privacy; and</text> </paragraph> <paragraph num="(2)"> <text>Have a minimum ratio of one bathtub or shower to eight occupants.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".52" heading="Illumination."> <paragraph num="A."> <text>Resident’s Room.</text> <paragraph num="(1)"> <text>An assisted living program shall ensure that a resident’s room:</text> <paragraph num="(a)"> <text>Is lighted by an outside window that:</text> <paragraph num="(i)"> <text>Contains a glass surface; and</text> </paragraph> <paragraph num="(ii)"> <text>Has square footage at least equal to 10 percent of the room’s required floor area;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has a minimum of 60 watts or the equivalent of artificial light provided for reading; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided with additional artificial light as required for other uses, such as night lights to enable residents to get to the bathroom at night.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An assisted living program shall provide additional lighting or watts upon reasonable request by the resident or the resident’s legal representative.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Common Use Areas. An assisted living program shall ensure that common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, have sufficient artificial lighting to prevent accidents and promote efficient service.</text> </paragraph> <paragraph num="C."> <text>The assisted living program shall provide sufficient light to meet the resident’s needs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".53" heading="Heating, Ventilation, and Air Conditioning."> <paragraph num="A."> <text>An assisted living program may not use space heaters unless approved by the State or local fire authorities.</text> </paragraph> <paragraph num="B."> <text>Minimum Temperature. The facility shall have a system that provides in areas used by residents a minimum temperature of 70°F in cold weather and a maximum temperature of 80°F in hot weather.</text> </paragraph> <paragraph num="C."> <text>Temperature Control.</text> <paragraph num="(1)"> <text>An assisted living program with a licensed capacity of one to eight beds shall provide at least one thermostat per building.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program with a licensed capacity of nine or more beds shall provide for each resident’s room:</text> <paragraph num="(a)"> <text>A thermostat; or</text> </paragraph> <paragraph num="(b)"> <text>An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An assisted living program shall:</text> <paragraph num="(1)"> <text>Ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors; and</text> </paragraph> <paragraph num="(2)"> <text>Provide forced mechanical exhaust ventilation or an approved equivalent for:</text> <paragraph num="(a)"> <text>All bathing compartments;</text> </paragraph> <paragraph num="(b)"> <text>Toilet rooms;</text> </paragraph> <paragraph num="(c)"> <text>Any area used for toileting;</text> </paragraph> <paragraph num="(d)"> <text>Soiled utility rooms;</text> </paragraph> <paragraph num="(e)"> <text>Designated smoking rooms; and</text> </paragraph> <paragraph num="(f)"> <text>Other rooms, as determined by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".54" heading="Radiators."> <paragraph num="A."> <text>If steam or hot water plumbing reaches a temperature in excess of 130°F or directly powered radiating surfaces are located in areas of the facility that are accessible to residents, the assisted living program shall position or shield the radiating surfaces in a manner to prevent resident contact.</text> </paragraph> <paragraph num="B."> <text>The assisted living program shall ensure that the radiator shielding device:</text> <paragraph num="(1)"> <text>Allows for efficient heat transfer;</text> </paragraph> <paragraph num="(2)"> <text>Is constructed to minimize vermin harborage;</text> </paragraph> <paragraph num="(3)"> <text>Is constructed of easily cleanable materials; and</text> </paragraph> <paragraph num="(4)"> <text>Complies with all State and local fire codes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".55" heading="Laundry."> <paragraph num="A."> <text>An assisted living program shall furnish laundry service, either on-site or off-site.</text> </paragraph> <paragraph num="B."> <text>An assisted living program shall ensure that the laundry is:</text> <paragraph num="(1)"> <text>Adequate to meet the needs of the residents;</text> </paragraph> <paragraph num="(2)"> <text>Processed and handled in a manner to prevent the spread of infection; and</text> </paragraph> <paragraph num="(3)"> <text>Adequately sanitized by the use of sufficient hot water or appropriate chemical agents, or a combination of both.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless otherwise agreed by the program and the resident, dry cleaning services are not considered part of required laundry services in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".56" heading="Telephones."> <paragraph num="A."> <text>An assisted living program with a licensed capacity of one to eight beds shall provide:</text> <paragraph num="(1)"> <text>At least one common-use telephone for residents; and</text> </paragraph> <paragraph num="(2)"> <text>A posting next to the common-use telephone or in a conspicuous location that contains the telephone numbers for the local police department and fire department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An assisted living program with a licensed capacity of nine to 16 beds shall provide at least one common-use telephone. If there are nine or more residents that do not have private telephones in their own rooms, the assisted living program shall provide a second common-use telephone.</text> </paragraph> <paragraph num="C."> <text>An assisted living program with a licensed capacity of 17 or more beds shall provide:</text> <paragraph num="(1)"> <text>That each resident’s room accommodates the use of the resident’s own private telephone; and</text> </paragraph> <paragraph num="(2)"> <text>An adequate number of common-use telephones to accommodate those residents who do not have private telephones installed in their rooms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".57" heading="Sanctions."> <paragraph num="A."> <text>If the Secretary determines that an assisted living program has violated this chapter, the Secretary, in addition to the sanctions set forth in this chapter, may impose one or more of the following:</text> <paragraph num="(1)"> <text>Restrict the number of residents the assisted living program may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Require the assisted living program to reduce the number of residents in care;</text> </paragraph> <paragraph num="(3)"> <text>Restrict the levels of care for which the assisted living program may provide services;</text> </paragraph> <paragraph num="(4)"> <text>Require the assisted living program, and any of its staff, to receive remedial instruction in a specific area;</text> </paragraph> <paragraph num="(5)"> <text>Require the assisted living program to use the services of and cover the costs of a management firm approved by the Department;</text> </paragraph> <paragraph num="(6)"> <text>Require the assisted living program to use the services of and cover the costs of a consultant to provide expertise related to:</text> <paragraph num="(a)"> <text>One or more licensure requirements;</text> </paragraph> <paragraph num="(b)"> <text>Standards of care; or</text> </paragraph> <paragraph num="(c)"> <text>Discharge planning.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Mandate staffing patterns which specify number of personnel, personnel qualifications, or both;</text> </paragraph> <paragraph num="(8)"> <text>Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Direct the assisted living program to correct the violations in a specific manner or within a specified time frame, or both;</text> </paragraph> <paragraph num="(10)"> <text>Notify, or require the assisted living program to notify, the representative or family of any resident who is affected by the noncompliance;</text> </paragraph> <paragraph num="(11)"> <text>Increase the frequency of monitoring visits during a specified period of time; or</text> </paragraph> <paragraph num="(12)"> <text>Enter into an agreement with the assisted living program establishing certain conditions for continued operation, including time limits for compliance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary determines that the assisted living program has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license.</text> </paragraph> <paragraph num="C."> <text>Appeals.</text> <paragraph num="(1)"> <text>An assisted living program aggrieved by the imposition of a sanction under §A(1), (2), or (3) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>An assisted living program aggrieved by the imposition of a sanction under §A(8) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>This section does not, however, create an appeal for a decision made under Regulation .23A of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".58" heading="Civil Money Penalties."> <paragraph num="A."> <text>The Secretary may impose a civil money penalty on a person if:</text> <paragraph num="(1)"> <text>The person maintains or operates an unlicensed assisted living program;</text> </paragraph> <paragraph num="(2)"> <text>A deficiency or an ongoing pattern of deficiencies exists in the assisted living program; or</text> </paragraph> <paragraph num="(3)"> <text>The person falsely advertises a program in violation of Regulation .06B(2) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>Nature, number, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of the program to correct, the deficiency or deficiencies; and</text> </paragraph> <paragraph num="(5)"> <text>An assisted living program’s prior history of compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the program of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Impose a per day civil money penalty until sustained compliance has been achieved;</text> </paragraph> <paragraph num="(2)"> <text>Permit the program the opportunity to correct the deficiencies by a specific date; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a per instance civil money penalty for each instance of violation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department permits a program the opportunity to correct the deficiencies by a specific date, and the program fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> <paragraph num="E."> <text>If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order is based;</text> </paragraph> <paragraph num="(2)"> <text>Amount of civil money penalties to be imposed; and</text> </paragraph> <paragraph num="(3)"> <text>Manner in which the amount of civil money penalties imposed was calculated.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".59" heading="Amount of Civil Money Penalties."> <paragraph num="A."> <text>A civil money penalty imposed on a person under this chapter may not exceed the amounts identified in Health-General §19-1809, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>Nature, number, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(3)"> <text>The efforts made by, and the ability of, the program to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>Whether the amount of the civil money penalty will jeopardize the financial ability of the program to continue operation as a program; and</text> </paragraph> <paragraph num="(5)"> <text>Other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".60" heading="Criminal Money Penalties — Hearings."> <paragraph num="A."> <text>A hearing on the appeal shall be held consistent with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".61" heading="Criminal Penalties."> <paragraph num="A."> <text>Operating Without a License.</text> <paragraph num="(1)"> <text>A person may not knowingly and willfully operate, maintain, or own an assisted living program without a license.</text> </paragraph> <paragraph num="(2)"> <text>A person who violates §A(1) of this regulation is guilty of a felony and on conviction is subject to:</text> <paragraph num="(a)"> <text>For a first offense, a fine not exceeding $10,000, imprisonment not exceeding 5 years, or both; and</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, a fine not exceeding $20,000, imprisonment not exceeding 5 years, or both.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Department finds a credible allegation that an assisted living program is operating without a license, the Department, or the Office of Health Care Quality, shall investigate whether residents in the assisted living program have been subjected to neglect, abuse, or financial exploitation.</text> </paragraph> <paragraph num="(4)"> <text>On receipt of a credible allegation, or after an investigation that results in a finding that residents in an unlicensed assisted living program have been subjected to neglect, abuse, or financial exploitation, the person operating the unlicensed program shall be subject to immediate prosecution under §A(2) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>If the person operating an unlicensed assisted living program fails or refuses to cooperate fully in an investigation by the Department, or the Office of Health Care Quality, conducted under §A(3) of this regulation, the person operating the unlicensed assisted living program shall be subject to immediate prosecution under §A(2) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>If the Department finds, after an investigation conducted under §A(3) of this regulation, that there is no reason to believe that residents in the assisted living program operating without a license have been subject to financial exploitation, neglect, or abuse:</text> <paragraph num="(a)"> <text>The Department shall provide written notice to the unlicensed assisted living program that the program shall come into compliance with licensure requirements within 30 days after receipt of the written notification; and</text> </paragraph> <paragraph num="(b)"> <text>The person operating the program may not be subject to prosecution under §A(2) of this regulation if the person:</text> <paragraph num="(i)"> <text>Has promptly and in good faith submitted a complete application to the Department for an assisted living program license;</text> </paragraph> <paragraph num="(ii)"> <text>Is awaiting a decision from the Department regarding the application; and</text> </paragraph> <paragraph num="(iii)"> <text>Has not been denied an assisted living program license on a prior occasion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>In recommending the amount of the criminal penalty under §A(2) of this regulation, the State shall consider factors including the nature, number, and seriousness of the violations.</text> </paragraph> <paragraph num="(8)"> <text>The Department, the Attorney General, a State’s Attorney, or a local health officer may petition a circuit court for injunctive relief against the operation of an assisted living program operating without a license.</text> </paragraph> <paragraph num="(9)"> <text>A violation of §A(1) of this regulation shall be a violation of the Consumer Protection Act.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Advertisement and Representation of an Assisted Living Program.</text> <paragraph num="(1)"> <text>A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>A person may not advertise an assisted living program in a misleading or fraudulent manner.</text> </paragraph> <paragraph num="(3)"> <text>A person who violates §B(1) of this regulation is subject to a civil money penalty imposed by the Secretary not exceeding $10,000 for each offense.</text> </paragraph> <paragraph num="(4)"> <text>In setting the amount of a civil money penalty on the program under §B(1) of this regulation, the Secretary shall consider factors including the nature, number, and seriousness of the violations and the ability of the assisted living program to pay the penalty.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Referral to an Assisted Living Program Operating Without a License.</text> <paragraph num="(1)"> <text>A person may not willfully and knowingly refer another person to an assisted living program that is operating without a license.</text> </paragraph> <paragraph num="(2)"> <text>A person who violates §C(1) of this regulation is subject to the following civil penalties:</text> <paragraph num="(a)"> <text>For a first offense, a civil penalty not exceeding $1,000;</text> </paragraph> <paragraph num="(b)"> <text>For a second offense, a civil penalty not exceeding $2,000; or</text> </paragraph> <paragraph num="(c)"> <text>For a third or subsequent offense, a civil penalty not exceeding $3,000.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Secretary shall remit all civil penalties collected under this regulation to the Office of Health Care Quality for the purposes of carrying out the provisions of Health-General Article, §19–1813, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".62" heading="Health Care Quality Account."> <paragraph num="A."> <text>The Department shall establish a health care quality account in the Department for assisted living programs.</text> </paragraph> <paragraph num="B."> <text>The health care quality account shall be funded by civil money penalties paid by assisted living programs.</text> </paragraph> <paragraph num="C."> <text>The Department shall use funds from the health care quality account to improve the quality of care in assisted living programs.</text> </paragraph> <paragraph num="D."> <text>Expenditure of funds may include, but is not limited to, the following:</text> <paragraph num="(1)"> <text>Funding for the establishment and operation of a demonstration project;</text> </paragraph> <paragraph num="(2)"> <text>A grant award;</text> </paragraph> <paragraph num="(3)"> <text>Relocation of residents in crisis situations;</text> </paragraph> <paragraph num="(4)"> <text>Provision of educational programs to assisted living programs, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and</text> </paragraph> <paragraph num="(5)"> <text>Any other purpose that will directly improve quality of care.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Suggestions for the use of funds may be submitted to the Department from:</text> <paragraph num="(1)"> <text>Members of the public;</text> </paragraph> <paragraph num="(2)"> <text>Advocacy organizations;</text> </paragraph> <paragraph num="(3)"> <text>Government agencies;</text> </paragraph> <paragraph num="(4)"> <text>Professional organizations, including trade associations;</text> </paragraph> <paragraph num="(5)"> <text>Assisted living programs; and</text> </paragraph> <paragraph num="(6)"> <text>Assisted living associations.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Decision on Expenditure of Funds.</text> <paragraph num="(1)"> <text>The Department, in its sole discretion, shall decide how to spend funds from the health care quality account.</text> </paragraph> <paragraph num="(2)"> <text>The Department’s decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore may not be appealed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".63" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the assisted living program:</text> <paragraph num="(1)"> <text>Informing the program of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the assisted living program has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the assisted living program of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is suspended by emergency action:</text> <paragraph num="(1)"> <text>The assisted living program shall immediately cease the use of all previously issued assisted living program licenses and return all paper licenses to the Department;</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall stop providing assisted living services immediately;</text> </paragraph> <paragraph num="(3)"> <text>The assisted living manager or their designee shall notify the residents and resident representatives of the suspension and make every reasonable effort to assist them in making safe and appropriate discharge plans, including to other licensed assisted living programs; and</text> </paragraph> <paragraph num="(4)"> <text>The OHCQ shall immediately notify the following entities of the emergency action:</text> <paragraph num="(a)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(b)"> <text>Local Department of Human Services or Adult Protective Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>In the event of an emergency suspension, the Department may assist in the relocation of residents.</text> </paragraph> <paragraph num="F."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter.</text> </paragraph> <paragraph num="G."> <text>Show Cause Hearing.</text> <paragraph num="(1)"> <text>In addition to the right to request a hearing consistent with Regulation .65 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension. The time limit for filing an appeal with the Office of Administrative Hearings to obtain an evidentiary hearing shall be followed by the filing of a request for a show cause hearing.</text> </paragraph> <paragraph num="(3)"> <text>The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension.</text> </paragraph> <paragraph num="(4)"> <text>The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who:</text> <paragraph num="(a)"> <text>Shall determine procedural issues;</text> </paragraph> <paragraph num="(b)"> <text>May impose reasonable time limits on each party’s oral argument; and</text> </paragraph> <paragraph num="(c)"> <text>Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may:</text> <paragraph num="(a)"> <text>Affirm the order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .65 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Hearing.</text> <paragraph num="(1)"> <text>The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .65 of this chapter and issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>An aggrieved person may file exceptions pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="(4)"> <text>If the Secretary’s final decision does not uphold the emergency suspension, the assisted living program may resume operation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".64" heading="Revocation of License."> <paragraph num="A."> <text>The Secretary, for cause shown, may notify the assisted living program of the Secretary’s decision to revoke the assisted living program’s license. The revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Department shall notify the assisted living program in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the assisted living program has failed to comply that form the basis for the revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the assisted living program is entitled to a hearing, if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the assisted living program shall stop providing services on the effective date of the revocation if the assisted living program does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the assisted living program is required to surrender its license to the Department if the revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The assisted living manager or their designee shall:</text> <paragraph num="(1)"> <text>Notify the residents and residents’ representatives of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>Make every reasonable effort to assist residents and resident representatives in making safe and appropriate discharge plans, including to other licensed assisted living programs; and</text> </paragraph> <paragraph num="(3)"> <text>Immediately notify the following entities of the revocation:</text> <paragraph num="(a)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(b)"> <text>Local Department of Human Services or Adult Protective Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>OHCQ shall notify the following entities of the revocation:</text> <paragraph num="(a)"> <text>Ombudsman within the Department of Aging or local area agency on aging; and</text> </paragraph> <paragraph num="(b)"> <text>Local Department of Human Services or Adult Protective Services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may assist in the relocation of residents or require the assisted living program to use the services of and cover the costs of a consultant to arrange safe and appropriate discharges for residents.</text> </paragraph> <paragraph num="F."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".65" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as provided in COMAR 10.01.03.18.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.18J.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 19, Subtitle 18, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 1, 1999 (26:22 Md. R. 1692); July 22, 2002 (29:14 Md. R. 1074)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 21, 2000 (27:16 Md. R. 1523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective August 15, 2000 (27:18 Md. R. 1664); amended permanently effective November 27, 2000 (27:23 Md. R. 2147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, C amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D, E amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15-1 adopted effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15-2 adopted effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17E—G adopted effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21F, K amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21P adopted effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C, E amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28D amended, and E—K adopted, effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29B amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .36A amended effective March 29, 2004 (31:6 Md. R. 508); December 19, 2005 (32:25 Md. R. 1941)</annotation> <annotation type="History" subtype="Administrative History">Regulation .46 amended effective March 29, 2004 (31:6 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .49B amended effective July 22, 2002 (29:14 Md. R. 1074)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.53 repealed and new Regulations .01—.64 adopted effective December 29, 2008 (35:26 Md. R. 2249)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective August 19, 2013 (40:16 Md. R. 1344); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective June 25, 2012 (39:12 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24D amended effective June 25, 2012 (39:12 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29 amended effective June 25, 2012 (39:12 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 28, 2025 (52:8 Md. R. 357)</annotation> </annotations> </chapter> <chapter num="15" heading="Application for Hospitals and Related Institutions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Health care facility within a correctional institution” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections.</text> </paragraph> <paragraph num="(3)"> <text>“Intermediate care facility for Individuals with Intellectual Disabilities or persons with related conditions (ICF/IID)” means a facility which provides residential care, treatment, or custody for the intellectually disabled.</text> </paragraph> <paragraph num="(4)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(5)"> <text>Related Institution.</text> <paragraph num="(a)"> <text>“Related institution” means an organized institution, environment, or home that:</text> <paragraph num="(i)"> <text>Maintains conditions or facilities and equipment to provide domiciliary, personal, or nursing care for two or more unrelated individuals who are dependent on the administrator, operator, or proprietor for nursing care or the subsistence of daily living in a safe, sanitary, and healthful environment; and</text> </paragraph> <paragraph num="(ii)"> <text>Admits or retains the individual for overnight care.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Related institution” does not include:</text> <paragraph num="(i)"> <text>An adult residential environment or home that is certified by the Department of Human Services;</text> </paragraph> <paragraph num="(ii)"> <text>A nursing facility or visiting nurse service that is conducted only by or for adherents of a recognized church or religious denomination, in accordance with tenets and practices that include reliance on treatment by spiritual means alone for healing; or</text> </paragraph> <paragraph num="(iii)"> <text>Any sheltered housing for the elderly, as defined in Article 70B, §1, Annotated Code of Maryland, that is certified by the Department of Aging, unless the housing provides for more than 11 individuals in one building that does not have more than one apartment unit, or if there are apartment units in the building, in one apartment unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Residential treatment center for emotionally disturbed children and adolescents” means a facility which houses two or more non-related children or adolescents referred for treatment upon the recommendation of a physician. The overall program must be approved by the Maryland Department of Health, the Department of Human Services, and the State Department of Education.</text> </paragraph> <paragraph num="(7)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application Requirements."> <paragraph num="A."> <text>Any person desiring to open a related institution or to continue the operation of a related institution shall file an application with the Secretary, on a form provided by the Secretary.</text> </paragraph> <paragraph num="B."> <text>Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their board members shall be submitted.</text> </paragraph> <paragraph num="C."> <text>Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee’s.</text> </paragraph> <paragraph num="D."> <text>The names of persons holding 2 percent or more of the stock or assets shall be disclosed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fee Assessment — Repealed." /> <annotations> <annotation type="Authority">Health-General Article, §§19-320 and 19-323, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 29, 1983 (10:17 Md. R. 1521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 12, 2007 (34:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 12, 2007 (34:3 Md. R. 297); August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 20, 1993 (20:25 Md. R. 1947); February 12, 2007 (34:3 Md. R. 297); January 20, 2014 (41:1 Md. R. 13)</annotation> </annotations> </chapter> <chapter num="16" heading="Limited Private Inpatient Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The purpose of this chapter is to:</text> <paragraph num="A."> <text>Outline the licensing, site, and staffing requirements for a provider of limited private inpatient facility services; and</text> </paragraph> <paragraph num="B."> <text>Provide a flexible model of service delivery and oversight.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>"Administration” means the Behavioral Health Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health or its designee.</text> </paragraph> <paragraph num="(3)"> <text>“Facility” means a limited private inpatient facility.</text> </paragraph> <paragraph num="(4)"> <text>“Facility service plan” means a statement of the facility’s mission, vision, scope, and purpose, as well as all specific requirements detailed under Regulation .10 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>“Individual treatment plan” means the plan prepared according to the requirements outlined in:</text> <paragraph num="(a)"> <text>Health-General Article, §10-706, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.21.03.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Joint Commission” means a voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“License” means a license issued by the Department to operate a limited private inpatient facility in this State.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed nurse” means a practical nurse or registered nurse licensed by the Board of Nursing under the provisions of Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>Limited Private Inpatient Facility.</text> <paragraph num="(a)"> <text>“Limited private inpatient facility” means a private inpatient treatment facility that provides mental health evaluation and treatment to adults 24 hours per day.</text> </paragraph> <paragraph num="(b)"> <text>“Limited private inpatient facility” does not include:</text> <paragraph num="(i)"> <text>A facility licensed to provide mental health services under authority of a statute other than Health-General Article, §§10-501—10-511, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>A facility that bills for reimbursement under the Medical Assistance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(12)"> <text>Usable Square Feet.</text> <paragraph num="(a)"> <text>“Usable square feet” means physical space that is available for resident use.</text> </paragraph> <paragraph num="(b)"> <text>“Usable square feet” does not include:</text> <paragraph num="(i)"> <text>Service areas;</text> </paragraph> <paragraph num="(ii)"> <text>Administrative offices;</text> </paragraph> <paragraph num="(iii)"> <text>Entrance ways including the space where a door swings open;</text> </paragraph> <paragraph num="(iv)"> <text>Closets, lockers, and wardrobes;</text> </paragraph> <paragraph num="(v)"> <text>Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or</text> </paragraph> <paragraph num="(vi)"> <text>Corridors.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following is incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Document Incorporated. “Standards for Behavioral Health Care, 2013 Edition, The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, Illinois 60181”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility."> <paragraph num="A."> <text>An individual is eligible for limited private inpatient facility services if the individual:</text> <paragraph num="(1)"> <text>Requires 24-hour inpatient mental health evaluation and treatment services but does not require acute or long-term psychiatric hospital services; and</text> </paragraph> <paragraph num="(2)"> <text>Has stated a willingness to comply with program rules.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual is not eligible for limited private inpatient facility services if the individual:</text> <paragraph num="(1)"> <text>Has a sole diagnosis of substance abuse, intellectual disability, or dementia;</text> </paragraph> <paragraph num="(2)"> <text>Is in need of immediate involuntary inpatient psychiatric admission;</text> </paragraph> <paragraph num="(3)"> <text>Is medically unstable as determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations; or</text> </paragraph> <paragraph num="(4)"> <text>Does not meet the eligibility criteria under §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensure Process."> <paragraph num="A."> <text>An applicant shall obtain a license from the Department before providing services.</text> </paragraph> <paragraph num="B."> <text>Initial and Renewal Licensure. In order to be licensed as a limited private inpatient facility, the facility shall:</text> <paragraph num="(1)"> <text>File an initial application with the Department that:</text> <paragraph num="(a)"> <text>Is on the written or electronic form approved by the Department with the requirement that all questions are answered and all required documents are attached; and</text> </paragraph> <paragraph num="(b)"> <text>Includes documentation of:</text> <paragraph num="(i)"> <text>Fire, liability, and hazard insurance coverage on the building in which the facility is located;</text> </paragraph> <paragraph num="(ii)"> <text>Compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety; and</text> </paragraph> <paragraph num="(iii)"> <text>Accreditation as a limited private inpatient facility or comparable facility by the Joint Commission under its Standards for Behavioral Health Care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be subject to:</text> <paragraph num="(a)"> <text>An initial survey to determine compliance with all appropriate statutes or regulations related to zoning, construction, fire safety, food service, and any other applicable codes; and</text> </paragraph> <paragraph num="(b)"> <text>The investigation of complaints and incidents by the Department;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit a facility service plan as required by Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Submit all required fees for licensure as specified in §I of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An application filed on behalf of a corporation, association, or governmental unit or agency shall:</text> <paragraph num="(1)"> <text>Be made by two officers of the corporation, association, or governmental unit or agency; and</text> </paragraph> <paragraph num="(2)"> <text>Include the:</text> <paragraph num="(a)"> <text>Names of all Board members;</text> </paragraph> <paragraph num="(b)"> <text>Names of persons holding 2 percent or more of the stock or assets; and</text> </paragraph> <paragraph num="(c)"> <text>Ownership of property, real estate, and equipment, if other than the licensee’s.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Display of License. The facility shall visibly post the facility’s license in a public area in the facility.</text> </paragraph> <paragraph num="E."> <text>The facility shall immediately notify the Department in writing of any change in the information the licensee had submitted with the most recent application, including the program service plan.</text> </paragraph> <paragraph num="F."> <text>To ensure the completion of any review or inspection by the Department of any major renovations, any construction of resident care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, that has not previously been provided by the facility, the facility shall notify the Department 60 days before the facility begins to accept occupancy or begins operation.</text> </paragraph> <paragraph num="G."> <text>Renewal of License.</text> <paragraph num="(1)"> <text>An application on the written or electronic form provided by the Department for the renewal of the license shall be made by an accredited facility within 30 calendar days of the exit date of the triennial survey conducted by the Joint Commission.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall grant a renewal license to an applicant to operate if the applicant submits:</text> <paragraph num="(a)"> <text>A completed application for license renewal with the required fees as specified by the Joint Commission;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the triennial survey report;</text> </paragraph> <paragraph num="(c)"> <text>A copy of the corrective actions taken for standards not met; and</text> </paragraph> <paragraph num="(d)"> <text>A copy of the certificate for accreditation by the Joint Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Loss of Accreditation.</text> <paragraph num="(1)"> <text>In the event of the loss of accreditation and the conclusion of all appeals to the Joint Commission, the facility may continue to be licensed only until the facility promptly arranges for the safe discharge of each resident to another facility or to appropriate outpatient services. The facility shall cease operation upon the discharge of all residents.</text> </paragraph> <paragraph num="(2)"> <text>When performing surveys, whether based on loss of accreditation, complaints received, or incidents reported, the Department shall determine compliance or noncompliance based on:</text> <paragraph num="(a)"> <text>Applicable State and federal law; and</text> </paragraph> <paragraph num="(b)"> <text>The Standards for Behavioral Health Care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>License Fees.</text> <paragraph num="(1)"> <text>A facility shall submit a written or electronic application on a form approved by the Department along with the fee established in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A facility that has filed an application for accreditation that meets the requirements for a provisional license shall:</text> <paragraph num="(a)"> <text>Submit a $500 nonrefundable license fee payable to the Department; and</text> </paragraph> <paragraph num="(b)"> <text>On receiving accreditation, pay an additional $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A facility shall submit a $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Provisional License.</text> <paragraph num="(1)"> <text>A facility that submits documentation showing the facility has applied to the Joint Commission for accreditation but has not yet been accredited at the time of application but otherwise meets the requirements for licensure shall be issued a provisional license.</text> </paragraph> <paragraph num="(2)"> <text>The provisional license shall be issued for a period of not greater than 1 year from issuance.</text> </paragraph> <paragraph num="(3)"> <text>A facility issued a provisional license shall be subject to subsequent surveys by the Department to determine compliance with this chapter and applicable standards of the Joint Commission until accreditation is awarded.</text> </paragraph> <paragraph num="(4)"> <text>If the Joint Commission denies accreditation to a facility before the expiration of the provisional license, the facility shall cease operations upon the prompt and safe discharge of all residents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Duration of License."> <paragraph num="A."> <text>The Secretary shall issue a license to an accredited facility for the term of the facility's accreditation.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall issue a provisional license to a non-accredited facility that otherwise meets the requirements for licensure for a term not to exceed 1 year with the requirement that the facility shall become accredited within that 1-year period or cease operations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Separate License Required."> <paragraph num="A."> <text>A separate license is required for facilities maintained on separate premises, even if both facilities are operated under the same management.</text> </paragraph> <paragraph num="B."> <text>A separate license is not required for separate buildings on the same grounds.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inspections."> <paragraph num="A."> <text>A facility shall be open to inspection by the Department at all times for the purpose of quality oversight and investigation of complaints or incidents.</text> </paragraph> <paragraph num="B."> <text>The facility’s administrative and medical records shall be available for review and for copying by the Department.</text> </paragraph> <paragraph num="C."> <text>New Facilities.</text> <paragraph num="(1)"> <text>A facility that is issued a provisional license shall be subject to inspections by the Department every 6 months and at any other time to determine compliance with:</text> <paragraph num="(a)"> <text>This chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The Standards for Behavioral Health Care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the facility has not attained accreditation by the Joint Commission within 1 year after beginning operations or has had its application for accreditation rejected, the facility shall:</text> <paragraph num="(a)"> <text>Cease operations; and</text> </paragraph> <paragraph num="(b)"> <text>Be subject to inspection to insure that all residents are receiving care and treatment in accordance with their needs as a safe discharge is arranged.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A facility shall be open to inspection by the Department to follow up on the findings identified in the accreditation report of the Joint Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Complaint Investigations."> <paragraph num="A."> <text>To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency:</text> <paragraph num="(1)"> <text>The Department shall refer the complaint directly to the facility; and</text> </paragraph> <paragraph num="(2)"> <text>The facility shall:</text> <paragraph num="(a)"> <text>Conduct an internal investigation into the complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Submit the investigation and supportive evidence to the Department within 30 days of the receipt of the complaint.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the Department determines that the facility has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a serious or life-threatening deficiency, the Department shall conduct an independent investigation using the standards:</text> <paragraph num="(1)"> <text>Of the Joint Commission; or</text> </paragraph> <paragraph num="(2)"> <text>Adopted by the Secretary under this subtitle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the:</text> <paragraph num="(1)"> <text>Facility; and</text> </paragraph> <paragraph num="(2)"> <text>Appropriate licensure board for resolution.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Facility Service Plan."> <paragraph num="A."> <text>The limited private inpatient facility shall provide services in accordance with the facility service plan submitted to and approved by the Department.</text> </paragraph> <paragraph num="B."> <text>A written facility service plan shall include at a minimum:</text> <paragraph num="(1)"> <text>The rationale for the facility including discussion of the organization’s mission, vision, and philosophy for provision of services;</text> </paragraph> <paragraph num="(2)"> <text>The range of services that the facility will provide;</text> </paragraph> <paragraph num="(3)"> <text>The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve;</text> </paragraph> <paragraph num="(4)"> <text>The composition of the facility's governing body, board of directors, or advisory committee, whichever applies;</text> </paragraph> <paragraph num="(5)"> <text>A description of staff or care providers necessary to provide the planned services and any necessary training requirements;</text> </paragraph> <paragraph num="(6)"> <text>The facility’s goals, objectives, and expected outcomes; and</text> </paragraph> <paragraph num="(7)"> <text>A detailed scope or description of services offered.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The administrative head of the licensee shall assure that the facility service plan is reviewed by its governing body and updated at least every 3 years.</text> </paragraph> <paragraph num="D."> <text>If the licensee makes any changes to its facility service plan, the licensee shall submit its revised facility service plan for the Department’s approval before implementation of the changes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Staffing."> <paragraph num="A."> <text>Required Staff. The facility director shall ensure that the facility’s staff is sufficient in numbers and qualifications to provide clinically appropriate services to the individuals served and includes, at a minimum:</text> <paragraph num="(1)"> <text>A facility director that is responsible for the programmatic and administrative services of the facility under the direction of the governing body;</text> </paragraph> <paragraph num="(2)"> <text>A clinical director who:</text> <paragraph num="(a)"> <text>Is a psychiatrist or psychologist who receives medical supervision by a psychiatrist; and</text> </paragraph> <paragraph num="(b)"> <text>Has overall responsibility for clinical services, including, at a minimum:</text> <paragraph num="(i)"> <text>Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices;</text> </paragraph> <paragraph num="(ii)"> <text>Medical aspects of quality management; and</text> </paragraph> <paragraph num="(iii)"> <text>Ensuring adequate clinical supervision of treatment staff;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A multidisciplinary licensed mental health professional staff that:</text> <paragraph num="(a)"> <text>Provides evaluation and treatment services; and</text> </paragraph> <paragraph num="(b)"> <text>Is in addition to the limited private inpatient facility psychiatrist;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensed nurse to provide for medication management, treatments, and other health care needs;</text> </paragraph> <paragraph num="(5)"> <text>Other direct care employees to provide for the treatment and monitoring of residents as required by the resident’s individual treatment plan;</text> </paragraph> <paragraph num="(6)"> <text>A physician to provide somatic medical services as required by the clients; and</text> </paragraph> <paragraph num="(7)"> <text>Maintenance and housekeeping staff who are trained and qualified to provide a well-maintained, safe, and sanitary environment for residents served by the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Training. Before providing services to residents, staff shall receive orientation and annual training as designated by the facility service plan including, at a minimum, training in:</text> <paragraph num="(1)"> <text>Crisis intervention and de-escalation techniques;</text> </paragraph> <paragraph num="(2)"> <text>Suicide prevention, including but not limited to identification of warning signs and symptoms;</text> </paragraph> <paragraph num="(3)"> <text>The facility’s disaster and fire safety plan;</text> </paragraph> <paragraph num="(4)"> <text>First aid, CPR, and emergency medical procedures; and</text> </paragraph> <paragraph num="(5)"> <text>Individual rights, as set forth in Health-General Article, Title 10, Subtitle 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Physical Environment Requirements."> <paragraph num="A."> <text>A limited private inpatient facility shall have a building that:</text> <paragraph num="(1)"> <text>Meets all relevant federal, State, or local ordinances, laws, regulations, and building codes; and</text> </paragraph> <paragraph num="(2)"> <text>Provides sufficient space for group and individual therapies, dining equipped with tables and chairs for resident meal service, and administrative services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The areas of the facility shall:</text> <paragraph num="(1)"> <text>Be well-lit and adequately ventilated;</text> </paragraph> <paragraph num="(2)"> <text>Be easily accessible;</text> </paragraph> <paragraph num="(3)"> <text>Be maintained in good repair, safe, clean, and free of insects and rodents and hazards;</text> </paragraph> <paragraph num="(4)"> <text>Provide a central heating system that can maintain the facility at a comfortable temperature;</text> </paragraph> <paragraph num="(5)"> <text>Be furnished with sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils for use by the residents;</text> </paragraph> <paragraph num="(6)"> <text>Be equipped with working smoke detectors and fire extinguishers and meets all requirements of the Maryland State Fire Code;</text> </paragraph> <paragraph num="(7)"> <text>Provide a secure storage area for medications if a resident has been determined capable of self-administration of medication and for residents’ funds and valuables;</text> </paragraph> <paragraph num="(8)"> <text>Have a telephone in the residence where residents can make calls and speak privately;</text> </paragraph> <paragraph num="(9)"> <text>Provide a space where residents may visit privately with friends and family; and</text> </paragraph> <paragraph num="(10)"> <text>Provide adequate general use space for therapy, activities, and recreation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Bedroom Area. The facility shall ensure that a bedroom has:</text> <paragraph num="(1)"> <text>A minimum of:</text> <paragraph num="(a)"> <text>80 usable square feet for a single bedroom; and</text> </paragraph> <paragraph num="(b)"> <text>180 usable square feet for a double-occupancy bedroom;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A door;</text> </paragraph> <paragraph num="(3)"> <text>Closet space and two drawers in a chest or dresser per resident;</text> </paragraph> <paragraph num="(4)"> <text>Window coverings for privacy;</text> </paragraph> <paragraph num="(5)"> <text>A bed with a clean mattress and pillow;</text> </paragraph> <paragraph num="(6)"> <text>A locked drawer or other secured storage for resident’s personal belongings; and</text> </paragraph> <paragraph num="(7)"> <text>No more than two residents per bedroom.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Toilet and Bathing Facilities. The facility shall ensure that the facility provides easily accessible and conveniently located toilet and bathing areas that allow for individual privacy and that:</text> <paragraph num="(1)"> <text>Are supplied with hand soap, toilet tissue, and hand towels or an electric hand dryer;</text> </paragraph> <paragraph num="(2)"> <text>Provide hot and cold running water with hot water being a minimum of 100°F and a maximum of 120°F;</text> </paragraph> <paragraph num="(3)"> <text>Are equipped with operable mechanical exhaust ventilation; and</text> </paragraph> <paragraph num="(4)"> <text>Provide at least:</text> <paragraph num="(a)"> <text>One hand sink and one toilet for every 8 residents; and</text> </paragraph> <paragraph num="(b)"> <text>One tub or shower for every 12 residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The facility shall ensure that a resident is provided per week, or more frequently if necessary or if requested by the resident, with at least:</text> <paragraph num="(1)"> <text>Two sets of linens;</text> </paragraph> <paragraph num="(2)"> <text>Two towels; and</text> </paragraph> <paragraph num="(3)"> <text>Two washcloths.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The facility shall provide for personal privacy in all bathrooms and in multiple occupancy bedrooms unless otherwise determined in the resident’s individual treatment plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Emergency Procedures."> <paragraph num="A."> <text>The program shall develop an emergency plan and procedures that shall be followed in the event of an internal or external emergency.</text> </paragraph> <paragraph num="B."> <text>The emergency plan and procedures shall;</text> <paragraph num="(1)"> <text>Be updated annually; and</text> </paragraph> <paragraph num="(2)"> <text>Include:</text> <paragraph num="(a)"> <text>Easily accessible emergency telephone numbers posted at or near a telephone for:</text> <paragraph num="(i)"> <text>Fire;</text> </paragraph> <paragraph num="(ii)"> <text>Police;</text> </paragraph> <paragraph num="(iii)"> <text>Ambulance;</text> </paragraph> <paragraph num="(iv)"> <text>Poison control; and</text> </paragraph> <paragraph num="(v)"> <text>The program’s on-call staff;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An emergency evacuation procedure that is explained to the residents and practiced by residents and staff on all shifts at a minimum of once every 3 months;</text> </paragraph> <paragraph num="(c)"> <text>Provisions for emergency lighting and fire detection and suppression systems operable during loss of power as required by the Maryland State Fire Code;</text> </paragraph> <paragraph num="(d)"> <text>A 3-day emergency food and water supply; and</text> </paragraph> <paragraph num="(e)"> <text>A relocation plan in the event that the facility is partially or entirely vacated, which shall include:</text> <paragraph num="(i)"> <text>A plan for transportation of the residents, at the facility’s expense, to relocate the residents;</text> </paragraph> <paragraph num="(ii)"> <text>A process for transfer of the medical records information for the residents in a manner to protect the residents’ privacy;</text> </paragraph> <paragraph num="(iii)"> <text>A system to track where and how the resident was transported;</text> </paragraph> <paragraph num="(iv)"> <text>How families will be notified, if desired by the resident; and</text> </paragraph> <paragraph num="(v)"> <text>Provisions that provide for any other associated costs at the facility’s expense.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Dietary Services."> <paragraph num="A."> <text>The facility shall ensure sufficient numbers of trained and qualified staff to meet the nutritional needs of residents served by the facility.</text> </paragraph> <paragraph num="B."> <text>Nutritional Needs. The facility shall ensure that:</text> <paragraph num="(1)"> <text>A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident;</text> </paragraph> <paragraph num="(3)"> <text>All food is prepared in accordance with all State and local sanitation and safe food handling requirements;</text> </paragraph> <paragraph num="(4)"> <text>Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements;</text> </paragraph> <paragraph num="(5)"> <text>Residents have access to snacks during the evening hours; and</text> </paragraph> <paragraph num="(6)"> <text>Staff prepares or arranges for the provision of therapeutic or special diets as ordered by the resident's physician or as needed by the resident's condition.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The facility shall ensure that menus are:</text> <paragraph num="(1)"> <text>Written at least 1 week in advance with portion sizes to meet the resident’s dietary needs; and</text> </paragraph> <paragraph num="(2)"> <text>Maintained on file, as served, for 2 months.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Dining Room. A facility shall provide a well-lit, adequately ventilated, and appropriately furnished dining area.</text> </paragraph> <paragraph num="E."> <text>Food Service.</text> <paragraph num="(1)"> <text>A facility shall have a kitchen that has adequate:</text> <paragraph num="(a)"> <text>Storage, refrigerator, and freezer space for perishable and nonperishable foods;</text> </paragraph> <paragraph num="(b)"> <text>Food preparation area or areas with cleanable surfaces;</text> </paragraph> <paragraph num="(c)"> <text>Equipment to deliver foods at safe and palatable temperatures;</text> </paragraph> <paragraph num="(d)"> <text>Space and equipment to wash, sanitize, and store utensils;</text> </paragraph> <paragraph num="(e)"> <text>Space to store and clean garbage cans;</text> </paragraph> <paragraph num="(f)"> <text>Ice-making capabilities;</text> </paragraph> <paragraph num="(g)"> <text>Equipment for the preparation of food; and</text> </paragraph> <paragraph num="(h)"> <text>Equipment for serving and distributing food to residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A facility’s dietary services shall be licensed by the local health department and comply with the requirements of COMAR 10.15.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Resident’s Rights."> <text>A facility shall:</text> <paragraph num="A."> <text>Explain to a resident their rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Provide, in writing, information regarding an individual’s rights as outlined in §A of this regulation to a resident; and</text> </paragraph> <paragraph num="C."> <text>Prominently display, in accessible centralized locations, the individual’s rights as outlined in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Records."> <paragraph num="A."> <text>The facility shall, either manually or electronically:</text> <paragraph num="(1)"> <text>Establish a record for a resident; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that entries in the record are dated, signed, and include the signer's degree or license, or if the signer has no degree or license, the signer's staff position.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall ensure that residents’ records are:</text> <paragraph num="(1)"> <text>Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of:</text> <paragraph num="(a)"> <text>Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Relevant federal statutes and regulations, including the Health Insurance Portability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Located so that the records are convenient and available to designated staff;</text> </paragraph> <paragraph num="(3)"> <text>Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and</text> </paragraph> <paragraph num="(4)"> <text>Subject to the requirements of confidentiality laws and regulations, are made available to the Department as necessary to carry out required activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Reporting of Deaths."> <text>Upon the death of an individual in the facility, the administrative head of the facility shall:</text> <paragraph num="A."> <text>Submit a written report to the Department within 5 working days of the death; and</text> </paragraph> <paragraph num="B."> <text>Use the form required by the Administration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Denial or Revocation of Approval."> <paragraph num="A."> <text>The Secretary may deny or revoke the license of a limited private inpatient facility that:</text> <paragraph num="(1)"> <text>Does not comply with:</text> <paragraph num="(a)"> <text>Health-General Article, §§10-501—10-511, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Health-General Article, §§10-701—10-713, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>The provisions of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Loses accreditation by the Joint Commission; or</text> </paragraph> <paragraph num="(3)"> <text>Fails to be awarded accreditation within 1 year of the issuance of a provisional license by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A facility that has lost or been denied accreditation by the Joint Commission may operate pending appeal only as permitted by this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctions."> <paragraph num="A."> <text>If the Secretary determines serious or life-threatening resident care deficiencies exist at the limited private inpatient facility or that the facility fails to take the necessary corrective action, the Secretary may:</text> <paragraph num="(1)"> <text>Revoke or place restrictions on the license;</text> </paragraph> <paragraph num="(2)"> <text>Impose a civil money penalty of not more than $10,000 per instance or per day;</text> </paragraph> <paragraph num="(3)"> <text>Impose a directed plan of correction; or</text> </paragraph> <paragraph num="(4)"> <text>Impose appropriate operating conditions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When considering whether to impose a civil money penalty and the amount of the penalty, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the licensee:</text> <paragraph num="(1)"> <text>Informing the licensee of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is immediately suspended, the licensee shall:</text> <paragraph num="(1)"> <text>Immediately return the license to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Stop providing services immediately.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter.</text> </paragraph> <paragraph num="F."> <text>The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .22 of this chapter and issue a proposed decision. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="G."> <text>If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Revocation of License."> <paragraph num="A."> <text>The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Secretary may revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Has been convicted of a felony that relates to Medicaid or Medicare or a crime involving moral turpitude;</text> </paragraph> <paragraph num="(2)"> <text>Does not comply with the requirements of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Fails to comply with the standards for the operation of a limited private inpatient facility or comparable facility as set forth in the Standards for Behavioral Health Care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall notify the licensee in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the licensee is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the revocation shall be stayed if a hearing is requested unless the license has been immediately suspended or the revocation is based upon the loss or denial of accreditation from the Joint Commission; and</text> </paragraph> <paragraph num="(7)"> <text>That the licensee is required to surrender the license to the Department if the revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Licensure Standards Waiver."> <paragraph num="A."> <text>The Department may grant a limited private inpatient facility a waiver from the licensure requirements under Regulation .12 of this chapter with, or without, conditions.</text> </paragraph> <paragraph num="B."> <text>Application for Licensure Standards Waiver.</text> <paragraph num="(1)"> <text>A facility shall submit a request for a waiver on a form developed by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The requestor shall provide in writing the:</text> <paragraph num="(a)"> <text>Regulation from which a waiver is sought;</text> </paragraph> <paragraph num="(b)"> <text>Reason the facility is unable to comply with the regulation;</text> </paragraph> <paragraph num="(c)"> <text>Reason that compliance with the regulation will impose a substantial hardship; and</text> </paragraph> <paragraph num="(d)"> <text>Reason that a waiver will not adversely affect residents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request, the Department shall review the statements in the application, and may:</text> <paragraph num="(1)"> <text>Inspect the limited private inpatient facility;</text> </paragraph> <paragraph num="(2)"> <text>Confer with the limited private inpatient facility director; or</text> </paragraph> <paragraph num="(3)"> <text>Discuss the request with the residents or their representatives to determine whether the residents or their representatives believe a waiver is in the residents’ best interest.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Grant or Denial of Licensure Standards Waiver.</text> <paragraph num="(1)"> <text>The Department may grant a waiver request if the Department determines that:</text> <paragraph num="(a)"> <text>Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and</text> </paragraph> <paragraph num="(b)"> <text>A waiver will not adversely affect residents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department determines that the conditions of §D(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Written Decision.</text> <paragraph num="(1)"> <text>The Department shall issue and mail to the applicant a written decision on a waiver request submitted under §B of this regulation within 45 days from receipt of the request and all appropriate supporting information.</text> </paragraph> <paragraph num="(2)"> <text>If the Department grants the waiver, the written decision shall include:</text> <paragraph num="(a)"> <text>The waiver’s duration; and</text> </paragraph> <paragraph num="(b)"> <text>Any conditions imposed by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>If the limited private inpatient facility violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the limited private inpatient facility will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-501—10-511, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 10, 2015 (42:24 Md. R. 1504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B,G,I amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 adopted effective December 19, 2016 (43:25 Md. R. 1384)</annotation> </annotations> </chapter> <chapter num="17" heading="Limited Service Hospital"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced life support” means initial resuscitation or emergency care provided to a patient with a serious illness or injury.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Facility” means a limited service hospital.</text> </paragraph> <paragraph num="(4)"> <text>“License” means a license issued by the Secretary to operate a limited service hospital in this State.</text> </paragraph> <paragraph num="(5)"> <text>“Limited service hospital” means a health care facility that:</text> <paragraph num="(a)"> <text>Is licensed as a hospital on or after January 1, 1999;</text> </paragraph> <paragraph num="(b)"> <text>Changes the type or scope of health care services offered by eliminating the facility's capability to admit or retain patients for overnight hospitalization; and</text> </paragraph> <paragraph num="(c)"> <text>Retains an emergency or urgent care center for the purpose of providing advanced life support.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Required."> <text>A person may not convert to, operate, or continue the operation of an existing limited service hospital without first obtaining a license from the Secretary. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Procedure."> <paragraph num="A."> <text>A person desiring to convert an existing facility, or to change the classification of an existing hospital to a limited service hospital, shall file an application with the Secretary, on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="B."> <text>An application on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency. The names of their board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if owned by other than the applicant. The names of persons holding 2 percent or more of the stock or assets of the limited service hospital shall be disclosed.</text> </paragraph> <paragraph num="C."> <text>Along with the application, the applicant shall provide:</text> <paragraph num="(1)"> <text>A statement signed by the applicant that the facility will be open 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>A plan describing the services to be provided by the facility, including but not limited to the following:</text> <paragraph num="(a)"> <text>Types and scope of services,</text> </paragraph> <paragraph num="(b)"> <text>A description of staff, including the number and types of health care professionals who will be on duty at all times, and</text> </paragraph> <paragraph num="(c)"> <text>Qualifications, duties, and responsibilities of personnel;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A written description of the facility's quality assurance program which includes, at a minimum:</text> <paragraph num="(a)"> <text>A description of how the facility will comply with Regulation .06A of this chapter, and</text> </paragraph> <paragraph num="(b)"> <text>The manner in which information will be collected;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Policies and procedures, including but not limited to the following:</text> <paragraph num="(a)"> <text>The transfer or referral of patients who require services that are not provided by the facility,</text> </paragraph> <paragraph num="(b)"> <text>The administration of medicines unique to the needs of the patients,</text> </paragraph> <paragraph num="(c)"> <text>Infection control procedures,</text> </paragraph> <paragraph num="(d)"> <text>Development and implementation of a quality assurance program,</text> </paragraph> <paragraph num="(e)"> <text>Pertinent safety practices, including the control of fire and mechanical hazards, and</text> </paragraph> <paragraph num="(f)"> <text>Preventive maintenance for equipment in the facility;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Protocols for obtaining specialized services;</text> </paragraph> <paragraph num="(6)"> <text>Protocols for emergency situations, including:</text> <paragraph num="(a)"> <text>Procedures for transporting individuals to hospitals or other health care facilities, and</text> </paragraph> <paragraph num="(b)"> <text>Plans to ensure that there will be sufficient nurses and other health professionals with appropriate training on duty to provide advanced life support;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A statement of the facility's role in the Emergency Medical Services System as approved by the Maryland Institute for Emergency Medical Services Systems; and</text> </paragraph> <paragraph num="(8)"> <text>A statement that the facility's emergency services are available to all persons regardless of ability to pay.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Fee. An application shall be accompanied by the nonrefundable license fee of $1,000.</text> </paragraph> <paragraph num="E."> <text>Issuance of a License. The Department shall issue a license to a facility that meets the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Renewal."> <paragraph num="A."> <text>The licensee shall file an application for license renewal on a written or electronic form provided by the Secretary at least 60 days before the current license expires.</text> </paragraph> <paragraph num="B."> <text>The licensee shall include with the application for license renewal:</text> <paragraph num="(1)"> <text>Updated documents listed in Regulation .03C(2) — (8) of this chapter if any of the information has changed during the current licensure period; and</text> </paragraph> <paragraph num="(2)"> <text>The nonrefundable license fee of $1,000.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards for Service."> <paragraph num="A."> <text>A facility shall comply with applicable federal, State, and local laws and regulations.</text> </paragraph> <paragraph num="B."> <text>Restriction of License—Nomenclature. A limited service hospital may not use in its title the words “emergency department”, “emergency center”, “emergency room”, or any other terminology in referring to the limited service hospital or any part of the facility that may convey to the public that the facility is prepared to provide the full range of emergency services that are normally provided by a hospital.</text> </paragraph> <paragraph num="C."> <text>Hours of Operation. The facility shall be open 24 hours a day, 7 days a week.</text> </paragraph> <paragraph num="D."> <text>Staff.</text> <paragraph num="(1)"> <text>At least one physician who is credentialed in emergency medicine shall be at the facility at all times.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall have a sufficient number of registered nurses and other health professionals with appropriate training to provide advanced life support.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Laboratory and Radiologic Services. The facility shall have basic x-ray and laboratory services available at all times and be staffed by at least:</text> <paragraph num="(1)"> <text>One radiology technician; and</text> </paragraph> <paragraph num="(2)"> <text>One laboratory technician.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Pharmaceutical Services.</text> <paragraph num="(1)"> <text>Pharmaceutical services shall be supervised by a pharmacist licensed to practice in this State.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall provide pharmaceutical services in accordance with accepted professional principles and appropriate federal, State, and local laws and regulations.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Clinical Records.</text> <paragraph num="(1)"> <text>The facility shall maintain clinical records for all patients in accordance with accepted professional standards and practices.</text> </paragraph> <paragraph num="(2)"> <text>Clinical records shall contain:</text> <paragraph num="(a)"> <text>Identification and summary, including, at least, the patient's name, Social Security number, marital status, age, sex, and home address;</text> </paragraph> <paragraph num="(b)"> <text>Name, address, and telephone number of the personal physician, dentist, parent or next of kin, or authorized representative;</text> </paragraph> <paragraph num="(c)"> <text>Evidence of assessment of the patient's needs, of establishment of an appropriate plan of initial and ongoing treatment, and of the care or services provided;</text> </paragraph> <paragraph num="(d)"> <text>Consent forms when required;</text> </paragraph> <paragraph num="(e)"> <text>Diagnostic and therapeutic orders;</text> </paragraph> <paragraph num="(f)"> <text>Reports of medication administration, treatments, and clinical findings; and</text> </paragraph> <paragraph num="(g)"> <text>Discharge summary including final diagnosis and prognosis.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Current clinical records and those of discharged patients shall be completed promptly. All clinical information pertaining to a patient shall be centralized in the patient's clinical record.</text> </paragraph> <paragraph num="(4)"> <text>Clinical records shall be retained for a period of not less than 5 years from the date of discharge or, in the case of a minor, 3 years after the patient becomes of age or 5 years, whichever is longer.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Equipment.</text> <paragraph num="(1)"> <text>A facility shall have the equipment necessary to provide at least the following care:</text> <paragraph num="(a)"> <text>Cardiac monitoring, defibrillation, and external pacing;</text> </paragraph> <paragraph num="(b)"> <text>Medication administration;</text> </paragraph> <paragraph num="(c)"> <text>Oxygen therapy;</text> </paragraph> <paragraph num="(d)"> <text>Airway management including endotracheal intubation;</text> </paragraph> <paragraph num="(e)"> <text>Respiratory ventilation; and</text> </paragraph> <paragraph num="(f)"> <text>Intravenous and intraosseous access and fluid therapy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All equipment at the facility shall be in good operating condition at all times.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Infection Control. A facility shall:</text> <paragraph num="(1)"> <text>Develop and implement policies and procedures on the use of standard precautions for infection control; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with the requirements of COMAR 10.06.01.07, except in an emergency life-threatening situation when it is not feasible or practical to comply with the infection control measures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Quality Assurance."> <paragraph num="A."> <text>The facility shall plan and implement a quality assurance program which includes:</text> <paragraph num="(1)"> <text>Monitoring and evaluation of the quality of patient care;</text> </paragraph> <paragraph num="(2)"> <text>Identification, evaluation, and resolution of care problems; and</text> </paragraph> <paragraph num="(3)"> <text>A peer review process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.</text> </paragraph> <paragraph num="C."> <text>Peer Review. The facility shall establish a peer review process that includes:</text> <paragraph num="(1)"> <text>A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually;</text> </paragraph> <paragraph num="(2)"> <text>Procedures, approved by a supervising physician, to identify and minimize risks to the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of each health care practitioner's annual evaluation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Equipment Quality Control.</text> <paragraph num="(1)"> <text>The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment.</text> </paragraph> <paragraph num="(2)"> <text>In developing its procedures, the facility shall consider:</text> <paragraph num="(a)"> <text>FDA recommendations; and</text> </paragraph> <paragraph num="(b)"> <text>The equipment manufacturer's recommendations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Quality Assurance Records. The facility shall document the following information for all quality assurance activities:</text> <paragraph num="(1)"> <text>A description of identified problems;</text> </paragraph> <paragraph num="(2)"> <text>Findings;</text> </paragraph> <paragraph num="(3)"> <text>Conclusions;</text> </paragraph> <paragraph num="(4)"> <text>Recommendations;</text> </paragraph> <paragraph num="(5)"> <text>Actions taken;</text> </paragraph> <paragraph num="(6)"> <text>Results; and</text> </paragraph> <paragraph num="(7)"> <text>Follow-up.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Risk Management Program."> <paragraph num="A."> <text>A facility shall comply with the requirements of COMAR 10.07.01.25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Utilization Review."> <text>A facility shall comply with the requirements of COMAR 10.07.01.13—.19.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Physician Credentialing."> <text>A facility shall comply with the requirements of COMAR 10.07.01.24.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Penalties."> <paragraph num="A."> <text>The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home.</text> </paragraph> <paragraph num="C."> <text>The Secretary may deny or revoke a license if the facility does not meet the requirements of:</text> <paragraph num="(1)"> <text>Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A person aggrieved by an action of the Secretary may request a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-301, 19-307, 19-307.1, 19-308, 19-319, 19-320, and 19-323, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective August 23, 1985 (12:19 Md. R. 1842); emergency status expired November 21, 1985; adopted permanently effective December 2, 1985 (12:24 Md. R. 2348)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Freestanding Emergency Facilities, repealed as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); repealed permanently effective October 30, 2000 (27:21 Md. R. 1975)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Limited Service Hospital, Regulations .01—.10 adopted as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="18" heading="Comprehensive Rehabilitation Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following words have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services, and which accredits those who provide the services.</text> </paragraph> <paragraph num="(2)"> <text>“Comprehensive physical rehabilitation services” has the meaning stated in Health-General Article, §19-1201(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Comprehensive rehabilitation facility” means any person who provides or holds itself out as providing comprehensive physical rehabilitation services on an out-patient basis.</text> </paragraph> <paragraph num="(4)"> <text>“Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter does not apply to a home health agency or special rehabilitation hospital.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Compliance Required."> <text>A comprehensive rehabilitation facility shall comply with the requirements of this chapter before the facility may provide:</text> <paragraph num="A."> <text>Comprehensive rehabilitation services; or</text> </paragraph> <paragraph num="B."> <text>A specialized rehabilitation program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Provisions."> <paragraph num="A."> <text>A comprehensive rehabilitation facility license is required before a person may provide or hold itself out as providing comprehensive physical rehabilitation services in the State.</text> </paragraph> <paragraph num="B."> <text>To obtain a comprehensive rehabilitation facility license, a person shall:</text> <paragraph num="(1)"> <text>Submit an application on the written or electronic form provided by the Secretary;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Secretary an application fee of $10; and</text> </paragraph> <paragraph num="(3)"> <text>Meet any requirement imposed under Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, or governmental unit or agency, and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed.</text> </paragraph> <paragraph num="D."> <text>A comprehensive rehabilitation license expires on the first anniversary of its effective date, unless it is renewed for a 1-year term.</text> </paragraph> <paragraph num="E."> <text>An application for the renewal of the license shall be made on the written or electronic form provided by the Secretary at least 60 days before expiration of the issued license.</text> </paragraph> <paragraph num="F."> <text>Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards of Operation."> <paragraph num="A."> <text>A comprehensive rehabilitation facility:</text> <paragraph num="(1)"> <text>Shall be accredited by the Commission on Accreditation of Rehabilitation Facilities;</text> </paragraph> <paragraph num="(2)"> <text>May provide only those specialized rehabilitation programs that the facility has been accredited to provide by the Commission on Accreditation of Rehabilitation Facilities;</text> </paragraph> <paragraph num="(3)"> <text>Shall meet the standards provided by the Commission on Accreditation of Rehabilitation Facilities as set forth in the 2002 Medical Rehabilitation Standards Manual (Commission on Accreditation of Rehabilitation Facilities, 4891 East Grant Road, Tucson, AZ 85712) which is incorporated by reference;</text> </paragraph> <paragraph num="(4)"> <text>Shall meet any other requirements that may be imposed by law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Accreditation.</text> <paragraph num="(1)"> <text>To allow a comprehensive rehabilitation facility to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any comprehensive rehabilitation facility that has submitted an appropriate application for accreditation.</text> </paragraph> <paragraph num="(2)"> <text>The waiver under this section shall be effective for not more than 2 years from the later of:</text> <paragraph num="(a)"> <text>July 1, 1986; or</text> </paragraph> <paragraph num="(b)"> <text>The date on which the facility begins operations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may inspect a comprehensive rehabilitation facility to assure that the facility meets the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Reports — Inspection."> <text>Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe, and all these records shall be open to inspection by the Secretary.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Enforcement."> <text>The Secretary may enforce the provisions of this chapter by any method available at law, including any civil action or criminal prosecution. Civil actions include, but are not limited to, license revocations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-1201 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1727); adopted permanently December 1, 1986 (13:24 Md. R. 2558)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 24, 1991 (18:12 Md. R. 1339); September 16, 2002 (29:18 Md. R. 1443)</annotation> </annotations> </chapter> <chapter num="19" heading="Private Review Agents" reason="Transferred to COMAR 31.10.21"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, .08—.10, and .12 amended, Regulation .07 repealed, Regulations .08—.12 recodified to .07—.11, and entire chapter recodified to new chapter COMAR 31.10.21 as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); amended and recodified permanently effective March 22, 1999 (26:6 Md. R. 491)</annotation> </annotations> </chapter> <chapter num="20" heading="Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID)"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to any person, whether public or private, operating a facility that:</text> <paragraph num="A."> <text>Provides health-related services on a regular basis to individuals:</text> <paragraph num="(1)"> <text>Who do not require hospital care; and</text> </paragraph> <paragraph num="(2)"> <text>Whose mental or physical condition requires services that:</text> <paragraph num="(a)"> <text>Are above the level of room and board; and</text> </paragraph> <paragraph num="(b)"> <text>Can be made available only through institutional facilities; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Has as its primary purpose the provision of health rehabilitative services for individuals with an intellectual disability or related conditions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Applicability of Health-General Article, Annotated Code of Maryland."> <text>An intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) shall be considered:</text> <paragraph num="A."> <text>A “related institution” under Health-General Article, §19-301, Annotated Code of Maryland, and shall be governed by the provisions of Title 19, Subtitle 3 of that article; and</text> </paragraph> <paragraph num="B."> <text>A provider of “services” under Health-General Article, §7-101, Annotated Code of Maryland, and shall be governed by the applicable provisions of Title 7 of that article including:</text> <paragraph num="(1)"> <text>Subtitle 4: Provisions of Services;</text> </paragraph> <paragraph num="(2)"> <text>Subtitle 5: State Residential Centers for Individuals With Mental Retardation if the facility is operated by the State;</text> </paragraph> <paragraph num="(3)"> <text>Subtitle 8: Transfers; and</text> </paragraph> <paragraph num="(4)"> <text>Subtitle 10: Rights of Individuals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Facility” means an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) within the scope of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“License” means a license issued by the Secretary to operate a facility.</text> </paragraph> <paragraph num="(4)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>A person shall be licensed by the Secretary before the person may operate a facility in the State.</text> </paragraph> <paragraph num="B."> <text>An applicant for a license shall:</text> <paragraph num="(1)"> <text>Submit to the Secretary an application:</text> <paragraph num="(a)"> <text>In the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>Signed and verified by the applicant; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pay to the Secretary an application fee in the amount provided in COMAR 10.07.15.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall issue a license to an applicant who meets the requirements of these regulations.</text> </paragraph> <paragraph num="D."> <text>A license authorizes the licensee to operate a facility while it is effective and is not transferable.</text> </paragraph> <paragraph num="E."> <text>Term and Renewal of License.</text> <paragraph num="(1)"> <text>A license expires on the first anniversary of its effective date unless it is renewed for a 1-year term as provided in this section.</text> </paragraph> <paragraph num="(2)"> <text>Before the license expires, the licensee may renew it for another 1-year term, if the licensee submits to the Secretary:</text> <paragraph num="(a)"> <text>A renewal application in the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with any requirement of the regulations for license renewal; and</text> </paragraph> <paragraph num="(c)"> <text>The license renewal fee provided in COMAR 10.07.15.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Secretary may:</text> <paragraph num="(1)"> <text>Deny a license to any applicant;</text> </paragraph> <paragraph num="(2)"> <text>Deny the renewal of a license to a licensee; or</text> </paragraph> <paragraph num="(3)"> <text>Revoke a license of a licensee if the applicant or licensee does not meet the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards of Operation."> <paragraph num="A."> <text>General. Whether or not a facility participates in Medicare or Medicaid, the facility shall meet the requirements set forth in 42 CFR § 483.400 et seq., which is incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Safety and Sanitation. The facility, its grounds, fixtures and equipment shall be:</text> <paragraph num="(1)"> <text>Maintained in good repair, clean, and attractive;</text> </paragraph> <paragraph num="(2)"> <text>Free of unnecessary accumulations of personal property or debris; and</text> </paragraph> <paragraph num="(3)"> <text>Free of hazards, insects, and rodents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control. The administrator shall:</text> <paragraph num="(1)"> <text>Establish policies and procedures to investigate, control, and prevent infections in the facility; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that facility staff follow these policies and procedures.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Personnel.</text> <paragraph num="(1)"> <text>The administrator shall provide orientation and training for all staff and volunteers.</text> </paragraph> <paragraph num="(2)"> <text>If the center provides care for individuals with Alzheimer's disease or related disorders:</text> <paragraph num="(a)"> <text>The administrator shall provide annual in-service education on the care of individuals with dementia; and</text> </paragraph> <paragraph num="(b)"> <text>Each employee shall complete an instructional unit on dementia as described in COMAR 10.07.02.40H before the later of:</text> <paragraph num="(i)"> <text>180 days from beginning of employment, or</text> </paragraph> <paragraph num="(ii)"> <text>One year from the effective date of these regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Employee Health Screening. A facility shall obtain certification that an employee or volunteer is free from tuberculosis in a communicable form as provided in Regulation .06 only if the employee or volunteer:</text> <paragraph num="(a)"> <text>Will be involved in the direct care of tuberculosis patients; or</text> </paragraph> <paragraph num="(b)"> <text>Is an immigrant from Africa, Asia, or Latin America.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Emergency Management Plans. State residential centers shall develop an emergency plan for all types of emergencies and disasters that shall include:</text> <paragraph num="(1)"> <text>Procedures that will be followed before, during, and after an emergency to address the following:</text> <paragraph num="(a)"> <text>The evacuation, transportation, or 72-hour shelter-in-place of individuals and staff served;</text> </paragraph> <paragraph num="(b)"> <text>Holding an annual practice drill coordinated with local emergency planners for sheltering-in-place or evacuating;</text> </paragraph> <paragraph num="(c)"> <text>Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions;</text> </paragraph> <paragraph num="(d)"> <text>Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation;</text> </paragraph> <paragraph num="(e)"> <text>The role of the resident, family member, or legal representative in the event of evacuation;</text> </paragraph> <paragraph num="(f)"> <text>Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and</text> </paragraph> <paragraph num="(g)"> <text>Establishing a communication protocol among all appropriate parties that includes redundant communication means;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notification to families, staff, and respective DDA regional office regarding the action that will be taken concerning the safety and well-being of the individuals served;</text> </paragraph> <paragraph num="(3)"> <text>The staff coverage, organization, and assignment of responsibilities that includes:</text> <paragraph num="(a)"> <text>Planning staff coverage needs for ongoing shelter-in-place or evacuations;</text> </paragraph> <paragraph num="(b)"> <text>Identifying staff members available to report for work or remain during extended periods; and</text> </paragraph> <paragraph num="(c)"> <text>Establishing staff notification and recall contingency plans and procedures;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities;</text> </paragraph> <paragraph num="(5)"> <text>Procedures to:</text> <paragraph num="(a)"> <text>Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning;</text> </paragraph> <paragraph num="(7)"> <text>An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request; and</text> </paragraph> <paragraph num="(8)"> <text>A summary statement of the facility's community surge capacity abilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Tuberculosis Screening."> <paragraph num="A."> <text>An employee or volunteer may be certified as required in Regulation .05D(3) in one of the following four ways:</text> <paragraph num="(1)"> <text>If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form subsequent to this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing may not be necessary except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department.</text> </paragraph> <paragraph num="(2)"> <text>If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done:</text> <paragraph num="(a)"> <text>Five Tuberculin Units (TU) of Purified Protein Derivative (PPD) shall be administered intradermally and the results read 48—72 hours subsequent to the administration of the test;</text> </paragraph> <paragraph num="(b)"> <text>An individual with induration of 5—9 mm and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 mm shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form;</text> </paragraph> <paragraph num="(c)"> <text>An individual with induration of 5—9 mm and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 mm or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a),(b), and (c), of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done:</text> <paragraph num="(a)"> <text>If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary.</text> </paragraph> <paragraph num="(b)"> <text>If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary.</text> </paragraph> <paragraph num="(c)"> <text>If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms.</text> </paragraph> <paragraph num="C."> <text>If the individual meets any of the following criteria, the facility shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual:</text> <paragraph num="(1)"> <text>A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer;</text> </paragraph> <paragraph num="(2)"> <text>Is currently being treated for tuberculosis disease or tuberculosis infection;</text> </paragraph> <paragraph num="(3)"> <text>Has chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or</text> </paragraph> <paragraph num="(4)"> <text>Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The facility shall maintain the following records:</text> <paragraph num="(1)"> <text>Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading and results of tests;</text> </paragraph> <paragraph num="(2)"> <text>Results of X-rays required in §A(3)(a),(b), and (c), of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspections."> <paragraph num="A."> <text>The Department shall inspect each facility at least annually to determine compliance with these regulations.</text> </paragraph> <paragraph num="B."> <text>A licensed facility and any facility applying for a license shall be open to inspection by the Department at all times.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-318, 19-320, and 19-323, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 28, 1987 (14:26 Md. R. 2747)</annotation> <annotation type="History" subtype="Administrative History">(COMAR 10.07.20 amended and transferred from COMAR 10.22.04 Public and Private Residential Care Facilities Serving the Mentally Retarded (ICF-MR))</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 20, 1989 (16:3 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective December 17, 2007 (34:25 Md. R. 2210)</annotation> </annotations> </chapter> <chapter num="21" heading="Hospice Care Programs"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <text>This chapter applies to any general or limited hospice care program as defined in Health-General Article, §19-901, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Attending physician” means the physician having the most significant role in the determination and delivery of the hospice patient's medical care.</text> </paragraph> <paragraph num="(2)"> <text>Bereavement Services.</text> <paragraph num="(a)"> <text>“Bereavement services” means counseling services provided to the patient's family after the patient's death.</text> </paragraph> <paragraph num="(b)"> <text>“Bereavement services” includes:</text> <paragraph num="(i)"> <text>Personal contacts with the family by hospice employees or volunteers;</text> </paragraph> <paragraph num="(ii)"> <text>Support groups; and</text> </paragraph> <paragraph num="(iii)"> <text>Referrals to other service providers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Family” means a group of two or more individuals related by legal status or affection who consider themselves a family.</text> </paragraph> <paragraph num="(5)"> <text>“General hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive medical, nursing, and other health-related services during illness and bereavement through home or inpatient care.</text> </paragraph> <paragraph num="(6)"> <text>“Home-based hospice services” means hospice care services provided to a patient in the patient's permanent or temporary residence.</text> </paragraph> <paragraph num="(7)"> <text>Hospice Care Program.</text> <paragraph num="(a)"> <text>“Hospice care program” means a coordinated, interdisciplinary program of hospice care services.</text> </paragraph> <paragraph num="(b)"> <text>“Hospice care program” includes a general or limited hospice care program.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Inpatient care services” means services provided by a general hospice care program for the purpose of pain control, symptom management, or respite.</text> </paragraph> <paragraph num="(9)"> <text>“License” means a license issued by the Secretary to operate a general or limited hospice care program.</text> </paragraph> <paragraph num="(10)"> <text>“Limited hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive nonskilled services during illness and bereavement through a home-based hospice care program.</text> </paragraph> <paragraph num="(11)"> <text>“Physician” means an individual who is licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Representative” means an individual with legal authority to make health care decisions on behalf of the patient as set forth in Regulation .20 of this chapter.</text> </paragraph> <paragraph num="(13)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(14)"> <text>“Skilled services” means services that may be provided by an individual licensed under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Social worker” means an individual licensed to practice in this State under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person may not operate or represent itself as operating a hospice care program in this State, without first obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>Section A of this regulation applies to a home health agency, hospital, related institution, or other licensed facility that operates a hospice care program that is distinct from the other services that it is authorized to provide.</text> </paragraph> <paragraph num="C."> <text>Types of Licenses. The Secretary shall require a hospice care program to be licensed as a:</text> <paragraph num="(1)"> <text>General hospice care program if the hospice care program provides, directly or by contract, home-based or inpatient care involving medical, nursing, or other skilled health services; or</text> </paragraph> <paragraph num="(2)"> <text>Limited hospice care program if the program provides, directly or by contract, nonskilled hospice services in a home-based setting.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A limited hospice care program shall refer patients in need of skilled services to a general hospice care program, or arrange for this care to be provided by an authorized health care provider.</text> </paragraph> <paragraph num="E."> <text>Duration of License. A license expires on the third anniversary of its effective date unless it is:</text> <paragraph num="(1)"> <text>Renewed as provided in Regulation .04 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Revoked as provided in Regulation .27 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A license to operate a hospice care program is not transferable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Procedure."> <paragraph num="A."> <text>Before a person may apply for a license to operate a general hospice care program, the person shall obtain a certificate of need from the Maryland Health Resources Planning Commission under Health-General Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The applicant shall submit an application for an initial license or renewal of a license on a written or electronic form provided by the Secretary.</text> </paragraph> <paragraph num="C."> <text>The applicant shall provide the following information with the application as applicable:</text> <paragraph num="(1)"> <text>If the applicant is an individual and is sole owner of the hospice care program, the name and address of the applicant;</text> </paragraph> <paragraph num="(2)"> <text>If the applicant proposes to operate a facility providing inpatient hospice care services and someone other than the applicant owns the building or real property, or both, the name and address of the owner or owners;</text> </paragraph> <paragraph num="(3)"> <text>If the applicant is a partnership or limited partnership:</text> <paragraph num="(a)"> <text>The legal name of the partnership or limited partnership;</text> </paragraph> <paragraph num="(b)"> <text>Any trade name used by the partnership or limited partnership; and</text> </paragraph> <paragraph num="(c)"> <text>The name and address of each partner;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the applicant is a corporation:</text> <paragraph num="(a)"> <text>The name of the corporation;</text> </paragraph> <paragraph num="(b)"> <text>The date of incorporation;</text> </paragraph> <paragraph num="(c)"> <text>The state of incorporation;</text> </paragraph> <paragraph num="(d)"> <text>The name and address of each director;</text> </paragraph> <paragraph num="(e)"> <text>If the corporation is incorporated outside of the State, the name and address of the resident agent of the corporation;</text> </paragraph> <paragraph num="(f)"> <text>The name and address of each officer; and</text> </paragraph> <paragraph num="(g)"> <text>The name and address of any stockholder owning more than 5 percent of the stock of a corporate applicant;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A statement that the applicant meets the requirements of Health-General Article, Title 19, Annotated Code of Maryland, and this chapter;</text> </paragraph> <paragraph num="(6)"> <text>The name of the individual who is to be the medical director of the hospice care program;</text> </paragraph> <paragraph num="(7)"> <text>The location and postal address of:</text> <paragraph num="(a)"> <text>The principal office of the proposed hospice care program;</text> </paragraph> <paragraph num="(b)"> <text>Any other office of the proposed hospice care program;</text> </paragraph> <paragraph num="(c)"> <text>Any facility providing inpatient hospice services to be operated by the hospice care program; and</text> </paragraph> <paragraph num="(d)"> <text>Any location where home-based hospice services are being provided in a residence owned or operated by the hospice; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A copy of the certificate of need determination from the Maryland Health Resources Planning Commission as required under §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary:</text> <paragraph num="(1)"> <text>Shall deny or revoke a license if the applicant or licensee has been convicted of a felony involving Medicaid fraud or other activity involving a nursing home, or its residents; or</text> </paragraph> <paragraph num="(2)"> <text>May deny or revoke a license of the applicant or licensee who does not otherwise meet the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspection by the Department."> <paragraph num="A."> <text>A licensee, or a program seeking licensure under this chapter, shall be open at all times to inspection by the Department, and any agency designated by the Secretary, to conduct an inspection.</text> </paragraph> <paragraph num="B."> <text>The Department may:</text> <paragraph num="(1)"> <text>Periodically inspect a hospice care program for compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct complaint investigations involving alleged licensure violations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Noncompliance.</text> <paragraph num="(1)"> <text>If the Secretary determines that a hospice care program fails to meet any provision of this chapter, the Secretary shall:</text> <paragraph num="(a)"> <text>Advise the hospice care program of the exact nature of the violation; and</text> </paragraph> <paragraph num="(b)"> <text>Require that the hospice care program specify what corrective action it is taking and monitor the hospice care program to ensure that it takes corrective action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>This section does not preclude the Secretary from imposing any of the sanctions set forth in Regulation .27 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Administration."> <paragraph num="A."> <text>Responsibility of Licensee. A licensee shall ensure that the operation of the hospice care program complies with Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="B."> <text>Governing Body.</text> <paragraph num="(1)"> <text>A licensee shall have a governing body for the hospice care program. The governing body shall:</text> <paragraph num="(a)"> <text>Determine the hospice care program's mission and purpose;</text> </paragraph> <paragraph num="(b)"> <text>Conduct a periodic community needs assessment;</text> </paragraph> <paragraph num="(c)"> <text>Provide outreach programs appropriate to the needs of the communities it serves, including making information about hospice care services readily available and providing appropriate educational activities to the communities it serves;</text> </paragraph> <paragraph num="(d)"> <text>Make efforts to secure access to hospice care services for the underserved;</text> </paragraph> <paragraph num="(e)"> <text>Adopt administrative and clinical policies and procedures, and review them annually;</text> </paragraph> <paragraph num="(f)"> <text>Monitor the hospice's program and establish a process to evaluate the quality of services it is providing;</text> </paragraph> <paragraph num="(g)"> <text>Have fiscal and fiduciary responsibility for the hospice care program including the review and approval of its budget;</text> </paragraph> <paragraph num="(h)"> <text>Ensure compliance with all legal requirements;</text> </paragraph> <paragraph num="(i)"> <text>Adopt bylaws which:</text> <paragraph num="(i)"> <text>Specify the role and responsibility of the governing body; and</text> </paragraph> <paragraph num="(ii)"> <text>Define the hospice care program's relationship to any other governing body; and</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Develop and implement a written conflict of interest policy which includes guidelines for the resolution of any existing or apparent conflict of interest.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All members of the governing body shall participate in an orientation program and continuing education to enable the members to fulfill their responsibilities to the hospice care program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Administrator.</text> <paragraph num="(1)"> <text>The governing body or the licensee shall:</text> <paragraph num="(a)"> <text>Identify an administrator who has full responsibility for the day-to-day operations of the hospice care program; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate the administrator's performance on at least an annual basis.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the absence of the administrator, the program shall remain under the continuous supervision of a designated individual with appropriate experience and training.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Policies and Procedures."> <text>The hospice care program shall adopt and implement written policies and procedures for:</text> <paragraph num="A."> <text>The use of advance directives;</text> </paragraph> <paragraph num="B."> <text>Identifying, reviewing, and discussing ethical dilemmas which arise in the care of patients and family;</text> </paragraph> <paragraph num="C."> <text>The use of specific treatment modalities in different hospice care settings, that is, palliative chemotherapy or radiation;</text> </paragraph> <paragraph num="D."> <text>The administration of medications, including who is qualified to administer medications;</text> </paragraph> <paragraph num="E."> <text>The management of treatment-related complications;</text> </paragraph> <paragraph num="F."> <text>The use of investigational drugs and implementation of research protocols;</text> </paragraph> <paragraph num="G."> <text>The initiation of resuscitation;</text> </paragraph> <paragraph num="H."> <text>Attending to remains at the time of death;</text> </paragraph> <paragraph num="I."> <text>The disposal of controlled drugs after death;</text> </paragraph> <paragraph num="J."> <text>The provision of inpatient hospice care including:</text> <paragraph num="(1)"> <text>Privacy needs, including space for families to gather;</text> </paragraph> <paragraph num="(2)"> <text>24-hour visitation and overnight stays; and</text> </paragraph> <paragraph num="(3)"> <text>Religious and spiritual worship;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Admission, transfer, and discharge, including criteria to be used for each; and</text> </paragraph> <paragraph num="L."> <text>Obtaining informed consent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Personnel."> <paragraph num="A."> <text>The hospice care program shall maintain sufficient health care professionals and volunteers to meet patient care needs.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall identify an interdisciplinary care team with responsibility for ensuring continuous assessment of the patient's and family's needs and implementation of an integrated plan of care. The hospice care program shall ensure that:</text> <paragraph num="(1)"> <text>A qualified health care professional coordinates the activities of the interdisciplinary care team;</text> </paragraph> <paragraph num="(2)"> <text>The number of individuals who perform interdisciplinary team services is consistent with the needs of patients and their families and the type of services provided by the hospice care program; and</text> </paragraph> <paragraph num="(3)"> <text>Each interdisciplinary care team consists of at least:</text> <paragraph num="(a)"> <text>The patient's attending physician;</text> </paragraph> <paragraph num="(b)"> <text>A physician with training in palliative care;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse with demonstrated experience in pain and symptom management and the performance of physical assessments;</text> </paragraph> <paragraph num="(d)"> <text>A master's degree-prepared social worker with clinical experience in counseling and casework for the terminally ill;</text> </paragraph> <paragraph num="(e)"> <text>A volunteer, or volunteers, supervised by an individual with management experience in a hospice care program; and</text> </paragraph> <paragraph num="(f)"> <text>A spiritual care counselor or counselors with education and experience in pastoral counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An interdisciplinary care team may include additional specialized team members needed to meet specific needs of patients as outlined in the patient's plan of care. Specialized team members may include allied therapists, art and music therapists, registered dietitians or licensed nutritionists, pharmacists, or nursing assistants.</text> </paragraph> <paragraph num="D."> <text>Specialized team members may be employees, volunteers, or contractual staff.</text> </paragraph> <paragraph num="E."> <text>Personnel Records. For all employees, volunteers, and contractual staff, the administrator shall ensure that there is:</text> <paragraph num="(1)"> <text>An accurate, complete, and current personnel record that includes:</text> <paragraph num="(a)"> <text>Verification of required licenses or certification;</text> </paragraph> <paragraph num="(b)"> <text>A signed conflict of interest statement;</text> </paragraph> <paragraph num="(c)"> <text>Written performance reviews;</text> </paragraph> <paragraph num="(d)"> <text>Documentation of all required training; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A job description for each position.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Outside Agreements. If a hospice care program utilizes the services of an outside entity to provide certain hospice services, the hospice care program shall enter into a written agreement with that entity which includes at a minimum:</text> <paragraph num="(1)"> <text>The service or services to be provided;</text> </paragraph> <paragraph num="(2)"> <text>The roles, rights, and responsibilities of the contracting entity;</text> </paragraph> <paragraph num="(3)"> <text>The roles, rights, and responsibilities of the hospice care program; and</text> </paragraph> <paragraph num="(4)"> <text>A plan to ensure that any individual providing services under this section shall have at least comparable training to that required by this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Orientation and Training.</text> <paragraph num="(1)"> <text>The hospice care program shall ensure that all licensed staff receive orientation and training, which includes at a minimum:</text> <paragraph num="(a)"> <text>The purpose and philosophy of hospice care;</text> </paragraph> <paragraph num="(b)"> <text>The skills necessary to provide for the physical care of the patient;</text> </paragraph> <paragraph num="(c)"> <text>The skills necessary to provide for the psychosocial and spiritual needs of the patient and family; and</text> </paragraph> <paragraph num="(d)"> <text>The need and importance of maintaining professional boundaries with the patient and the patient's family.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospice care program shall have written criteria and a clear process for recruiting, selecting, and supervising volunteers, ensuring that:</text> <paragraph num="(a)"> <text>Any volunteer who provides direct patient care receives appropriate orientation and at least 16 hours of training which includes, at a minimum:</text> <paragraph num="(i)"> <text>The purpose and philosophy of hospice care;</text> </paragraph> <paragraph num="(ii)"> <text>The role of the volunteer in hospice;</text> </paragraph> <paragraph num="(iii)"> <text>Concepts of death and dying;</text> </paragraph> <paragraph num="(iv)"> <text>Communication skills;</text> </paragraph> <paragraph num="(v)"> <text>Care and comfort measures;</text> </paragraph> <paragraph num="(vi)"> <text>The physical, psychosocial, and spiritual issues related to death and dying;</text> </paragraph> <paragraph num="(vii)"> <text>The concept of the hospice family;</text> </paragraph> <paragraph num="(viii)"> <text>Patient rights;</text> </paragraph> <paragraph num="(ix)"> <text>Confidentiality;</text> </paragraph> <paragraph num="(x)"> <text>Bereavement;</text> </paragraph> <paragraph num="(xi)"> <text>Infection control;</text> </paragraph> <paragraph num="(xii)"> <text>Safety; and</text> </paragraph> <paragraph num="(xiii)"> <text>Stress management; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A volunteer, other than those specified in §G(2)(a) of this regulation, receives appropriate orientation regarding the volunteer's role in the hospice care program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Training shall be specifically tailored to ensure that staff is capable of providing care to meet the individual needs of patients.</text> </paragraph> <paragraph num="(4)"> <text>The hospice care program shall provide continuing inservice education for all employees and volunteers providing direct patient services at least:</text> <paragraph num="(a)"> <text>Once a year for volunteers; and</text> </paragraph> <paragraph num="(b)"> <text>Four times a year for employees.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Quality Assurance."> <paragraph num="A."> <text>The governing body shall ensure that the hospice care program conducts ongoing quality assurance and utilization review.</text> </paragraph> <paragraph num="B."> <text>Quality Assurance Program. The governing body shall assure that the hospice care program develops and implements a quality assurance and improvement program to assess and improve the quality of services being provided by the program.</text> </paragraph> <paragraph num="C."> <text>The quality assurance and improvement program shall:</text> <paragraph num="(1)"> <text>Focus on:</text> <paragraph num="(a)"> <text>The needs, expectations, and satisfaction of patients and their families; and</text> </paragraph> <paragraph num="(b)"> <text>All services provided by the hospice care program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have outcomes and results that are measurable and which may be incorporated into systemic changes in the program's operation;</text> </paragraph> <paragraph num="(3)"> <text>Require the systematic collection, review, and evaluation of information and data and the analysis of trends identified through the quality assurance process;</text> </paragraph> <paragraph num="(4)"> <text>Require that regular reports are prepared and reviewed by the governing body and appropriate personnel;</text> </paragraph> <paragraph num="(5)"> <text>Provide for prompt and appropriate response to incidents when the patient's health and safety is at risk; and</text> </paragraph> <paragraph num="(6)"> <text>Include proactive strategies to improve the quality of services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospice care program shall:</text> <paragraph num="(1)"> <text>Establish goals and standards to measure the quality of the services being delivered and define how these standards are measured;</text> </paragraph> <paragraph num="(2)"> <text>Maintain records to demonstrate the effectiveness of its quality assurance activities;</text> </paragraph> <paragraph num="(3)"> <text>Implement changes based upon results of the evaluated data; for example, when problems are identified in the provision of services, the hospice care program shall document corrective actions taken, including ongoing monitoring, revisions of policies and procedures, and educational interventions;</text> </paragraph> <paragraph num="(4)"> <text>Identify the individual responsible for performing the quality assurance functions as set forth in this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Review the quality assurance and improvement program at least annually and make revisions as necessary.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospice care program shall be held accountable by the governing body for accomplishing the goals and standards that are established as part of the quality assurance and improvement system.</text> </paragraph> <paragraph num="F."> <text>Utilization Review.</text> <paragraph num="(1)"> <text>The hospice care program shall have a written plan for monitoring the allocation and utilization of patient and family services in order to identify and resolve concerns relating to the allocation and utilization of these services. The plan shall include:</text> <paragraph num="(a)"> <text>Goals and objectives for utilization review;</text> </paragraph> <paragraph num="(b)"> <text>Use of objective written criteria or treatment protocols to guide decisions about utilization of services;</text> </paragraph> <paragraph num="(c)"> <text>The analysis of the need for services;</text> </paragraph> <paragraph num="(d)"> <text>Time frames for review;</text> </paragraph> <paragraph num="(e)"> <text>Methods for identifying utilization review concerns and mechanisms for resolving problems; and</text> </paragraph> <paragraph num="(f)"> <text>A confidentiality policy consistent with legal and regulatory requirements.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospice care program shall review the utilization review plan at least annually and make revisions as necessary.</text> </paragraph> <paragraph num="(3)"> <text>The plan shall include a monitoring protocol to address the following utilization concerns:</text> <paragraph num="(a)"> <text>The appropriateness of the services being provided, including the level of intensity;</text> </paragraph> <paragraph num="(b)"> <text>Patient admissions, including delays in the admission process; and</text> </paragraph> <paragraph num="(c)"> <text>Delays in the provision of services and specific treatment modalities.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When the hospice care program identifies utilization problems, the hospice care program shall document corrective actions taken, including ongoing monitoring and educational interventions, as well as revisions to policies and procedures, and changes in the provision of services.</text> </paragraph> <paragraph num="(5)"> <text>Reports to the Secretary.</text> <paragraph num="(a)"> <text>Within 90 days after the close of a hospice care program's fiscal year, the hospice care program shall submit to the Department a report of the services it provided during the last fiscal year.</text> </paragraph> <paragraph num="(b)"> <text>The report shall include the:</text> <paragraph num="(i)"> <text>Types of services the hospice care program provided;</text> </paragraph> <paragraph num="(ii)"> <text>Number of patients provided each type of service;</text> </paragraph> <paragraph num="(iii)"> <text>Number of family members provided each type of service; and</text> </paragraph> <paragraph num="(iv)"> <text>Changes in the number of patients or family members provided services from the previous year.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="The Interdisciplinary Plan of Care."> <paragraph num="A."> <text>The interdisciplinary team shall develop a written plan of care for each patient and family. The plan of care shall reflect current standards of practice. The hospice care program shall document the attending physician's participation in the development, revision, and overall approval of the plan of care.</text> </paragraph> <paragraph num="B."> <text>The interdisciplinary plan of care shall reflect continuing communication between the attending physician and other members of the interdisciplinary care team. The interdisciplinary plan of care shall be reviewed, and revised if necessary, at least:</text> <paragraph num="(1)"> <text>Every 14 days after admission for home-based hospice services; and</text> </paragraph> <paragraph num="(2)"> <text>Every 7 days after admission for inpatient hospice services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The interdisciplinary plan of care shall recognize the patient's and family's psychological, social, religious, and cultural values.</text> </paragraph> <paragraph num="D."> <text>The interdisciplinary plan of care shall reflect efforts that the hospice care program staff and volunteers have made to:</text> <paragraph num="(1)"> <text>Maximize patient independence;</text> </paragraph> <paragraph num="(2)"> <text>Deliver services at the convenience of the patient, family, and caregiver;</text> </paragraph> <paragraph num="(3)"> <text>Arrange respite services for caregivers;</text> </paragraph> <paragraph num="(4)"> <text>Bridge gaps in the patient's care giving network; and</text> </paragraph> <paragraph num="(5)"> <text>Adapt the home environment to meet the patient's physical needs.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The interdisciplinary plan of care shall be based on the initial assessments conducted by interdisciplinary care team members.</text> </paragraph> <paragraph num="F."> <text>The hospice care program shall encourage the patient and family to participate in developing and implementing the interdisciplinary plan of care.</text> </paragraph> <paragraph num="G."> <text>Contents. The interdisciplinary plan of care shall include, at a minimum:</text> <paragraph num="(1)"> <text>Identification of patient and family problems and needs;</text> </paragraph> <paragraph num="(2)"> <text>Identification of realistic and achievable goals, objectives, and outcomes;</text> </paragraph> <paragraph num="(3)"> <text>The frequency and mix of services, including bereavement needs;</text> </paragraph> <paragraph num="(4)"> <text>The level of care to be provided;</text> </paragraph> <paragraph num="(5)"> <text>Prescribed medication and treatments; and</text> </paragraph> <paragraph num="(6)"> <text>Required medical equipment.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Bereavement Plan.</text> <paragraph num="(1)"> <text>The hospice care program shall initiate a written plan of bereavement intervention at the time of admission to the hospice which shall be incorporated into the patient's plan of care.</text> </paragraph> <paragraph num="(2)"> <text>The bereavement plan shall be based on an assessment of the needs of the family and shall recognize the family's social, religious, and cultural values.</text> </paragraph> <paragraph num="(3)"> <text>At a minimum, the bereavement plan shall include the:</text> <paragraph num="(a)"> <text>Scope and frequency of bereavement services; and</text> </paragraph> <paragraph num="(b)"> <text>Family's acceptance of bereavement services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Continuity of Care."> <paragraph num="A."> <text>The hospice care program shall coordinate care to ensure continuity of care for the patient and family.</text> </paragraph> <paragraph num="B."> <text>Any changes in service delivery are to be based on an assessment of the patient's and family's needs and desires for hospice services and a hospice care program's transfer and discharge criteria.</text> </paragraph> <paragraph num="C."> <text>The hospice care program shall:</text> <paragraph num="(1)"> <text>Provide case management for the patient and family;</text> </paragraph> <paragraph num="(2)"> <text>Maintain an accurate, complete, and documented record of services and activities provided to the patient and family;</text> </paragraph> <paragraph num="(3)"> <text>Collaborate with other organizations and individuals providing care to the patient and family to ensure coordination of services;</text> </paragraph> <paragraph num="(4)"> <text>Provide on-call medical and nursing services in response to patient and family needs;</text> </paragraph> <paragraph num="(5)"> <text>Ensure the safety of staff and inform the patient and family of any personnel, service, or access limitations; and</text> </paragraph> <paragraph num="(6)"> <text>Have reporting mechanisms to keep all staff informed and updated about patient care changes to ensure continuity and coordination of care among interdisciplinary team members.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Transfer or Discharge."> <paragraph num="A."> <text>If the hospice care program does not provide inpatient hospice services directly, the hospice care program shall have a written transfer agreement with a hospice care program which provides those services.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall provide adequate and appropriate information about the patient and family at the time of transfer or discharge.</text> </paragraph> <paragraph num="C."> <text>When a patient and family transfers from one hospice care program to another or from home-based service to inpatient service, or vice versa, the current care provider shall provide a written summary of:</text> <paragraph num="(1)"> <text>The services being provided;</text> </paragraph> <paragraph num="(2)"> <text>The specific medical, psychosocial, spiritual, or other problems that require intervention or follow-up; and</text> </paragraph> <paragraph num="(3)"> <text>Any scheduled follow-up by a current interdisciplinary care team member.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospice care program shall document the specific reasons for transferring or discharging a patient from its program. These reasons may include:</text> <paragraph num="(1)"> <text>The patient moves from the service area;</text> </paragraph> <paragraph num="(2)"> <text>There is a change in terminal status;</text> </paragraph> <paragraph num="(3)"> <text>The patient and family are unwilling to comply with the interdisciplinary plan of care or consistently act in a way which compromises the standards of care;</text> </paragraph> <paragraph num="(4)"> <text>Issues of patient safety cannot be resolved;</text> </paragraph> <paragraph num="(5)"> <text>Issues of staff safety cannot be resolved; or</text> </paragraph> <paragraph num="(6)"> <text>Patient and family desire for discharge.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospice care program shall prepare a written discharge summary which shall be provided to the patient or the patient's family before the patient's discharge.</text> </paragraph> <paragraph num="F."> <text>Before discharge, the hospice care program shall assess the patient's and family's continuing care needs and make referrals to appropriate services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Physician Services."> <paragraph num="A."> <text>Medical Director. The hospice care program shall have a medical director who shall be:</text> <paragraph num="(1)"> <text>A physician licensed to practice medicine in this State; and</text> </paragraph> <paragraph num="(2)"> <text>Knowledgeable about the psychosocial and medical aspects of hospice care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director Duties. The medical director is responsible for:</text> <paragraph num="(1)"> <text>Reviewing, coordinating, and managing the clinical and medical care for all patients in the hospice care program;</text> </paragraph> <paragraph num="(2)"> <text>Consulting with attending physicians regarding pain and symptom control;</text> </paragraph> <paragraph num="(3)"> <text>Reviewing patient eligibility for hospice services;</text> </paragraph> <paragraph num="(4)"> <text>Acting as the medical resource for the interdisciplinary team;</text> </paragraph> <paragraph num="(5)"> <text>Acting as the liaison to physicians in the community; and</text> </paragraph> <paragraph num="(6)"> <text>Designating a physician to contact in case the medical director is unavailable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Attending Physician. An attending physician shall provide initial and ongoing medical services to the patient and participate in the development of the interdisciplinary plan of care.</text> </paragraph> <paragraph num="D."> <text>Attending Physician Duties. At a minimum, the attending physician shall provide the following information before the patient is admitted to the hospice care program:</text> <paragraph num="(1)"> <text>Admitting diagnosis and prognosis;</text> </paragraph> <paragraph num="(2)"> <text>Current medical findings;</text> </paragraph> <paragraph num="(3)"> <text>Dietary restrictions;</text> </paragraph> <paragraph num="(4)"> <text>Medication and treatment orders, including instructions for symptom management; and</text> </paragraph> <paragraph num="(5)"> <text>Information concerning the medical management of patient conditions unrelated to the terminal illness.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospice care program shall ensure that the attending physician designates another physician to contact in case the attending physician is unavailable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Nursing Services."> <paragraph num="A."> <text>Nursing services shall be provided by licensed or certified personnel, trained or experienced in hospice care and supervised by a registered nurse with training or experience in hospice nursing. All nursing services shall be provided in accordance with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall provide nurse staffing levels based on:</text> <paragraph num="(1)"> <text>An assessment of patient and family care needs;</text> </paragraph> <paragraph num="(2)"> <text>The experience level of the nursing staff available to provide services; and</text> </paragraph> <paragraph num="(3)"> <text>Available assistance from support service staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospice care program shall provide nursing services in accordance with each patient's interdisciplinary plan of care.</text> </paragraph> <paragraph num="D."> <text>Registered Nurse. A registered nurse shall:</text> <paragraph num="(1)"> <text>Conduct the initial assessment of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Regularly reevaluate the patient's nursing needs;</text> </paragraph> <paragraph num="(3)"> <text>Initiate the plan of care and necessary revisions;</text> </paragraph> <paragraph num="(4)"> <text>Prepare clinical and progress notes, coordinate services, and inform the physician and other personnel of changes in the patient's condition and needs;</text> </paragraph> <paragraph num="(5)"> <text>Inform the patient and family in regard to the patient's nursing needs; and</text> </paragraph> <paragraph num="(6)"> <text>Supervise other nursing personnel.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The initial assessment or any reevaluation of the patient's care needs may not be conducted by a licensed practical nurse or nursing assistant. Licensed practical nurses and nursing assistants shall provide all services in accordance with the patient's interdisciplinary plan of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Ancillary Services."> <paragraph num="A."> <text>The hospice care program shall have a written plan for the provision of pharmacy, laboratory, radiology, chemotherapy, and other ancillary services. When the service is provided by an organization other than the hospice care program, the hospice care program shall enter into a written agreement with the provider of ancillary services which specifies the services being provided and the procedures for accessing those services.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall ensure that ancillary services are provided in accordance with federal and State laws and regulations.</text> </paragraph> <paragraph num="C."> <text>Pharmacy Services.</text> <paragraph num="(1)"> <text>The hospice care program shall employ or contract with a licensed pharmacist to:</text> <paragraph num="(a)"> <text>Supervise all pharmacy services;</text> </paragraph> <paragraph num="(b)"> <text>Serve as a consultant to the interdisciplinary care team; and</text> </paragraph> <paragraph num="(c)"> <text>Ensure that all drugs and biologicals are prescribed, dispensed, administered, stored, and disposed of in accordance with applicable laws and regulations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospice care program shall have a system to obtain and provide drugs on an emergency basis, 24 hours per day, 7 days a week.</text> </paragraph> <paragraph num="(3)"> <text>The hospice care program shall maintain a drug profile for each patient and conduct periodic drug reviews and monitoring of each patient.</text> </paragraph> <paragraph num="(4)"> <text>The hospice care program shall ensure that the interdisciplinary care team and the patient and the patient's family are made aware of each medication prescribed for the patient and are given any instructions concerning the administration of prescribed medications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Counseling Services."> <paragraph num="A."> <text>Counseling Services. The hospice care program shall provide counseling services which address the needs of patients and families. The hospice care program shall provide counseling services as set forth in §§B—E of this regulation.</text> </paragraph> <paragraph num="B."> <text>Social Work Services. Social work services are to be based on an initial and continuing assessment of patient and family psychosocial needs. Each assessment shall be conducted by a social worker. Services shall be provided in accordance with each patient's interdisciplinary plan of care with the goal of assisting the patient and family in adjusting to the psychosocial aspects of terminal illness.</text> </paragraph> <paragraph num="C."> <text>Spiritual Services. The hospice care program shall provide spiritual services that are based on an initial, ongoing assessment of the spiritual needs of the patient and family. Spiritual services are to be consistent with patient and family beliefs and desires. These services shall be provided by a member of the interdisciplinary care team or by local clergy or spiritual counselors.</text> </paragraph> <paragraph num="D."> <text>Nutritional Counseling. The hospice care program shall provide nutritional counseling to the patient and family. This counseling shall be provided by either a registered nurse, registered dietitian, or licensed nutritionist as specified in the interdisciplinary plan of care.</text> </paragraph> <paragraph num="E."> <text>Bereavement services shall be provided as set forth in Regulation .10H of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Emergency Services."> <paragraph num="A."> <text>The hospice care program shall ensure that emergency services are available 24 hours per day, 7 days a week.</text> </paragraph> <paragraph num="B."> <text>Emergency services are to include, at a minimum:</text> <paragraph num="(1)"> <text>Registered nurse and physician services;</text> </paragraph> <paragraph num="(2)"> <text>Palliative medications; and</text> </paragraph> <paragraph num="(3)"> <text>Other services, equipment, and supplies necessary to meet the patient's immediate needs as directed by the patient's plan of care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Volunteer Services."> <paragraph num="A."> <text>The hospice care program's volunteer services shall play a vital role in enhancing the quality of care delivered to the patient and family by encouraging community participation in the overall hospice care program.</text> </paragraph> <paragraph num="B."> <text>Volunteers may assist with patient care and administrative services consistent with the hospice care program's policies and in accordance with the requirements of this regulation.</text> </paragraph> <paragraph num="C."> <text>Volunteers shall document their activities in the clinical record.</text> </paragraph> <paragraph num="D."> <text>Volunteers shall comply with personnel policies and procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Medical Records."> <paragraph num="A."> <text>The hospice care program shall establish and maintain a clinical record for each patient in accordance with accepted principles of practice for maintaining medical records. The record is to be complete, accurately documented, readily accessible, and systematically organized to facilitate retrieval of information.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall:</text> <paragraph num="(1)"> <text>Document clinical and progress notes in a patient's medical record within 14 days of a visit or provision of services;</text> </paragraph> <paragraph num="(2)"> <text>Obtain the attending physician's signature on an order within 30 days of receiving a verbal order; and</text> </paragraph> <paragraph num="(3)"> <text>Close a medical record within 30 days of a patient's discharge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Access to or release of a patient's medical record by the hospice care program is permitted only with the consent of the patient or the patient's representative, or as required by law.</text> </paragraph> <paragraph num="D."> <text>If services are not provided directly by the hospice care program, the hospice care program shall obtain a copy of the applicable medical record or written summary of services provided and maintain it in the hospice care program's medical record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Patient's Representative."> <paragraph num="A."> <text>A hospice care program shall recognize the authority of:</text> <paragraph num="(1)"> <text>A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>A representative payee or other similar fiduciary; or</text> </paragraph> <paragraph num="(7)"> <text>Any other person, if that person was designated by a patient who was competent at the time of designation, and the patient or representative has provided the hospice care program with documentation of the designation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospice care program may not recognize the authority of the patient's representative if the representative attempts to exceed the authority:</text> <paragraph num="(1)"> <text>Stated in the instrument that grants the representative authority; or</text> </paragraph> <paragraph num="(2)"> <text>Established by State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospice care program shall document in the patient's record the name of the representative, including a copy, when applicable, of the designation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Patient's Rights."> <paragraph num="A."> <text>The hospice care program shall provide the patient or representative with a written notice of the patient's rights in advance of furnishing care. Documentation verifying receipt of and understanding of this information shall be included as part of the patient's record.</text> </paragraph> <paragraph num="B."> <text>The patient has the right to:</text> <paragraph num="(1)"> <text>Be treated with consideration and respect for individual dignity;</text> </paragraph> <paragraph num="(2)"> <text>Confidentiality in all aspects of service or treatment;</text> </paragraph> <paragraph num="(3)"> <text>Privacy;</text> </paragraph> <paragraph num="(4)"> <text>Be free from physical or mental abuse;</text> </paragraph> <paragraph num="(5)"> <text>Participate in the planning of the patient's hospice care;</text> </paragraph> <paragraph num="(6)"> <text>Formulate advance directives as provided under State law;</text> </paragraph> <paragraph num="(7)"> <text>Have all personal property treated with respect;</text> </paragraph> <paragraph num="(8)"> <text>Refuse care and services, including continued participation in the hospice care program;</text> </paragraph> <paragraph num="(9)"> <text>Be informed of short-term inpatient care options available for pain control, management, and respite;</text> </paragraph> <paragraph num="(10)"> <text>Be informed of the hospice care program's discharge policy;</text> </paragraph> <paragraph num="(11)"> <text>Make complaints or grievances to the hospice care program, government agencies, or other persons without threat or fear of retaliation; and</text> </paragraph> <paragraph num="(12)"> <text>Be informed orally and in writing, before care is initiated, of the extent to which payment may be expected from the patient, third-party payers, and any other source of funding known to the hospice care program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospice care program shall ensure that all employees and volunteers respect the rights of a patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Complaint Procedure."> <paragraph num="A."> <text>A hospice care program shall establish a procedure under which a patient or family member may make a complaint to a representative of the hospice care program.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall investigate and seek to resolve the complaint.</text> </paragraph> <paragraph num="C."> <text>The hospice care program shall maintain documentation which reflects findings of the investigation and efforts to resolve the complaint.</text> </paragraph> <paragraph num="D."> <text>The hospice care program shall inform each patient and family of:</text> <paragraph num="(1)"> <text>Its complaint procedure; and</text> </paragraph> <paragraph num="(2)"> <text>The address and telephone number of the Department's Licensing and Certification Administration.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may conduct investigations of complaints involving alleged violations of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Infection Control."> <paragraph num="A."> <text>The hospice care program shall have an infection control program in all care settings.</text> </paragraph> <paragraph num="B."> <text>There is to be a written plan for identifying, preventing, and controlling the spread of infection, which includes:</text> <paragraph num="(1)"> <text>Identifying an individual responsible for implementing and monitoring the infection control program;</text> </paragraph> <paragraph num="(2)"> <text>Establishing a system for periodic review and update of infection control policies and procedures governing at a minimum:</text> <paragraph num="(a)"> <text>Personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>Aseptic and isolation techniques;</text> </paragraph> <paragraph num="(c)"> <text>Supplies, medication, and food storage; and</text> </paragraph> <paragraph num="(d)"> <text>Waste disposal;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reviewing patient and family caregiver practices to identify potential exposure to infection; and</text> </paragraph> <paragraph num="(4)"> <text>Ensuring that the infection control program is monitored, reviewed, and evaluated regularly at specified intervals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Safety and Emergency Preparedness."> <paragraph num="A."> <text>The hospice care program shall have a safety and emergency preparedness program that includes, at a minimum:</text> <paragraph num="(1)"> <text>A plan for reporting, monitoring, and following up on all accidents, injuries, and safety hazards;</text> </paragraph> <paragraph num="(2)"> <text>Education for patient and family caregivers, employees, and volunteers in the safe use of medical equipment;</text> </paragraph> <paragraph num="(3)"> <text>Evidence that equipment maintenance and safety requirements have been met; and</text> </paragraph> <paragraph num="(4)"> <text>A safe and sanitary system for identifying, handling, and disposing of special medical wastes that meets the requirements of COMAR 10.06.06.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospice care program shall ensure that the emergency preparedness program provides appropriate continuous support and care to patients and families and other caregivers during natural or man-made disasters.</text> </paragraph> <paragraph num="C."> <text>The hospice care program shall monitor, review, and evaluate the safety and emergency preparedness program at regularly specified intervals.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Home-Based Hospice Care Provided in a Licensed Health Care Facility."> <paragraph num="A."> <text>Professional Management.</text> <paragraph num="(1)"> <text>When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice care program shall assume full responsibility for professional management of the patient's hospice care in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice and the facility shall have a written agreement which defines their respective roles and responsibilities in regard to the care of the patient.</text> </paragraph> <paragraph num="(3)"> <text>The hospice care program shall designate a qualified health care professional from the hospice care program who shall coordinate the activities of the interdisciplinary care team and the health care facility staff to assure continuous assessments of the patient's and family's needs, and to ensure implementation of an integrated plan of care.</text> </paragraph> <paragraph num="(4)"> <text>All core hospice services, specifically, physician, nursing, social work, and counseling services identified in the plan of care, shall be provided directly by hospice care program employees or volunteers and may not be delegated to the health care facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Plan of Care.</text> <paragraph num="(1)"> <text>The interdisciplinary plan of care shall be jointly developed by the patient, the patient's family, the hospice care program, and the licensed health care facility, and shall identify the services to be provided by each entity.</text> </paragraph> <paragraph num="(2)"> <text>Both providers shall review the interdisciplinary plan of care at intervals specified in the plan, and shall jointly update the plan as necessary to reflect the patient's current status.</text> </paragraph> <paragraph num="(3)"> <text>Both the hospice care program and the health care provider shall maintain the interdisciplinary plan of care in their respective medical records.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Inpatient Hospice Care."> <paragraph num="A."> <text>In addition to the other requirements of this chapter, when a hospice care program delivers inpatient care, the hospice care program shall provide nursing services 24 hours a day in a manner sufficient to meet the total nursing needs identified in the patient's plan of care. A registered nurse shall be on duty during each shift.</text> </paragraph> <paragraph num="B."> <text>The hospice care program shall design and equip all areas for the comfort and privacy of patients and family members. Specifically, the hospice care program shall:</text> <paragraph num="(1)"> <text>Provide accommodation for family members to remain with the patient throughout the night;</text> </paragraph> <paragraph num="(2)"> <text>Provide an adequate supply of hot water at all times for patient use;</text> </paragraph> <paragraph num="(3)"> <text>Have available at all times a quantity of linen sufficient for proper care and comfort of patients;</text> </paragraph> <paragraph num="(4)"> <text>Make provisions for isolating patients with infectious diseases; and</text> </paragraph> <paragraph num="(5)"> <text>Provide privacy for patient/family visitation and accommodations for the family's privacy immediately after a patient's death.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospice care program shall provide food services designed to meet the nutritional needs of the patients, in accordance with physician orders and the following guidelines:</text> <paragraph num="(1)"> <text>At least three meals shall be served each day with not more than 14 hours between the evening meal and breakfast, unless otherwise prescribed by the patient's physician;</text> </paragraph> <paragraph num="(2)"> <text>All foods shall be stored, prepared, and served as required by COMAR 10.15.03; and</text> </paragraph> <paragraph num="(3)"> <text>Medically prescribed special diets shall be planned by a registered dietitian or licensed nutritionist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to all other State and federal requirements, all medications shall be labeled, stored, and administered in accordance with the following:</text> <paragraph num="(1)"> <text>All medications shall be ordered by a physician;</text> </paragraph> <paragraph num="(2)"> <text>All medications shall be administered by a licensed nurse or physician;</text> </paragraph> <paragraph num="(3)"> <text>All medications shall be labeled in accordance with Health-General Article, §21-221(a), Annotated Code of Maryland, 21 U.S.C. §§301 et seq. and 801 et seq.;</text> </paragraph> <paragraph num="(4)"> <text>All medications shall be stored in locked compartments under proper temperature control and all schedule II drugs shall be maintained separately from other medications and secured by use of two different locks; and</text> </paragraph> <paragraph num="(5)"> <text>All medications no longer needed by the patient shall be destroyed in the presence of two witnesses authorized by the hospice care program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Penalties."> <paragraph num="A."> <text>Administrative Penalty.</text> <paragraph num="(1)"> <text>The Secretary may, for noncompliance with any regulation under this chapter, impose an administrative penalty of up to:</text> <paragraph num="(a)"> <text>$500 for a first violation; and</text> </paragraph> <paragraph num="(b)"> <text>$1,000 for a subsequent repeated violation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors:</text> <paragraph num="(a)"> <text>The number, nature, and seriousness of the violations;</text> </paragraph> <paragraph num="(b)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(c)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients;</text> </paragraph> <paragraph num="(d)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(e)"> <text>Other factors as justice may require.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Suspension.</text> <paragraph num="(1)"> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall deliver a written notice to the hospice care program:</text> <paragraph num="(a)"> <text>Informing it of the emergency suspension;</text> </paragraph> <paragraph num="(b)"> <text>Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(c)"> <text>Notifying the hospice care program of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="(4)"> <text>When a license is suspended by emergency action:</text> <paragraph num="(a)"> <text>The hospice care program shall immediately return the license to the Department;</text> </paragraph> <paragraph num="(b)"> <text>The hospice care program shall stop providing hospice services immediately; and</text> </paragraph> <paragraph num="(c)"> <text>The licensee shall notify the patients or their representatives of the suspension and make every reasonable effort to assist them in making other hospice service arrangements.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In the event of an emergency suspension, the Department may assist in the relocation of patients.</text> </paragraph> <paragraph num="(6)"> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .28 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="(8)"> <text>If the Secretary's final decision does not uphold the emergency suspension, the hospice care program may resume operation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Suspension or Revocation of License.</text> <paragraph num="(1)"> <text>The Secretary, for cause shown, may suspend or revoke the hospice care program's license.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall notify the hospice care program in writing of the following:</text> <paragraph num="(a)"> <text>The effective date of the suspension or revocation;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the suspension or revocation;</text> </paragraph> <paragraph num="(c)"> <text>The regulations with which the licensee has failed to comply that form the basis for the suspension or revocation;</text> </paragraph> <paragraph num="(d)"> <text>That the hospice care program is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(e)"> <text>That the hospice care program shall stop providing services on the effective date of the suspension or revocation if the hospice care program does not request a hearing;</text> </paragraph> <paragraph num="(f)"> <text>That the suspension or revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(g)"> <text>That the hospice care program is required to surrender its license to the Department if the suspension or revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The licensee shall notify the patients or their representatives of any final suspension or revocation and make every reasonable effort to assist them in making other hospice care arrangements. The Department may assist in the relocation of residents.</text> </paragraph> <paragraph num="(4)"> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-210 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03.</text> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-903 and 19-907, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 2, 1989 (16:19 Md. R. 2104)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.16 repealed and new Regulations .01—.28 adopted effective August 10, 1998 (25:16 Md. R. 1274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="22" heading="Hospice Care Programs: Hospice House Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>This chapter is effective January 1, 2014.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to all general hospice care programs that operate a hospice house.</text> </paragraph> <paragraph num="C."> <text>An operator of a hospice house shall also comply with all the requirements contained in COMAR 10.07.21 that are applicable to general hospice care programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In addition to the definition contained in §B of this regulation, definitions set forth in COMAR 10.07.21.02 are applicable to this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Hospice house” means a residence operated by a Maryland licensed general hospice care program that provides home-based hospice services to hospice patients in a home-like environment and the care is not billed as general inpatient care.</text> </paragraph> <paragraph num="(2)"> <text>“Primary hospice nurse” means the registered nurse who is assigned to oversee the nursing care of an individual hospice patient from the time of admission until the time of discharge.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter, the following document is incorporated by reference: NFPA 101, The Life Safety Code, as adopted by the State Fire Prevention Commission in COMAR 29.06.01.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="License Required."> <text>A person may not operate a hospice house without first obtaining a license to operate a general hospice care program.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Staffing Plan."> <paragraph num="A."> <text>Following an analysis of the number of beds the hospice house intends to serve and the individual needs of each resident, the general hospice care program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter.</text> </paragraph> <paragraph num="B."> <text>The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents.</text> </paragraph> <paragraph num="C."> <text>Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable.</text> </paragraph> <paragraph num="D."> <text>The staffing plan shall be reviewed annually and as needed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Management of the Hospice House."> <paragraph num="A."> <text>The administrator of the general hospice care program shall identify a manager of the hospice house who has full responsibility for the day-to-day operations of the hospice house.</text> </paragraph> <paragraph num="B."> <text>The administrator shall evaluate the manager’s performance on an annual basis.</text> </paragraph> <paragraph num="C."> <text>In the absence of the hospice house manager, the hospice house shall remain under the continuous supervision of a designated individual with appropriate experience and training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Staff Qualifications."> <paragraph num="A."> <text>The hospice house shall be staffed by sufficient numbers of personnel to ensure that the hospice house is capable of meeting the requirements of this chapter, and all applicable federal, State, and local laws and regulations.</text> </paragraph> <paragraph num="B."> <text>In addition to meeting all of the other qualifications and requirements for hospice employees, all hospice house staff shall participate in an orientation program and annual training to ensure competency in maintaining the hospice house and meeting the needs of residents in accordance with the plan of care.</text> </paragraph> <paragraph num="C."> <text>Staff who administer medications to residents shall meet all requirements of the Maryland Board of Nursing or Maryland Board of Physicians.</text> </paragraph> <paragraph num="D."> <text>Documentation of all required training shall be included in the employee’s personnel record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Admission Requirements."> <text>A hospice patient appropriate for care in their own home who does not require general inpatient services may be eligible for care in a hospice house, in accordance with the hospice house admission policy.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Residential Agreement."> <paragraph num="A."> <text>Patients admitted to the hospice house or their representatives shall sign, before or at the time of admission, a patient agreement that:</text> <paragraph num="(1)"> <text>Is a clear and complete statement of commitments agreed to by the parties and the services provided in the hospice house;</text> </paragraph> <paragraph num="(2)"> <text>Is accurate, legible, and communicated in a language understandable to patient and family; and</text> </paragraph> <paragraph num="(3)"> <text>Conforms to all applicable federal, State, and local laws and requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The residential agreement shall include, at a minimum:</text> <paragraph num="(1)"> <text>The services to be provided by the hospice house;</text> </paragraph> <paragraph num="(2)"> <text>An explanation of the hospice house’s complaint or grievance procedure;</text> </paragraph> <paragraph num="(3)"> <text>Procedures to be followed in transferring the patient to another facility;</text> </paragraph> <paragraph num="(4)"> <text>The availability of secure storage of patient’s belongings;</text> </paragraph> <paragraph num="(5)"> <text>The patient’s and family’s rights and obligations concerning use of the hospice house, including common areas;</text> </paragraph> <paragraph num="(6)"> <text>Written plan and provisions for continued emergency preparedness services;</text> </paragraph> <paragraph num="(7)"> <text>An acknowledgement that the patient or the patient’s representative has reviewed all hospice house rules, requirements, restrictions, or special conditions that the general hospice program will impose on the patient; and</text> </paragraph> <paragraph num="(8)"> <text>Admission and discharge policies and procedures including:</text> <paragraph num="(a)"> <text>Those actions, circumstances or conditions which may result in the patient’s discharge from the hospice house;</text> </paragraph> <paragraph num="(b)"> <text>The procedures which the hospice house shall follow if it intends to discharge a patient without the patient’s agreement, thereby terminating the residential agreement; and</text> </paragraph> <paragraph num="(c)"> <text>The procedures which the patient shall follow if the patient wishes to terminate the residential agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The residential agreement shall include financial provisions, which include at a minimum:</text> <paragraph num="(1)"> <text>Rate structure and payment provisions covering:</text> <paragraph num="(a)"> <text>All rates to be charged to the patient, including but not limited to any non-service related charges; and</text> </paragraph> <paragraph num="(b)"> <text>Payment arrangements and fees, if known, for third-party services not covered by the residential agreement, but arranged for by either the patient, patient’s representative, or the hospice house; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Obligations of the hospice house and the patient, or the patient’s representative, as to:</text> <paragraph num="(a)"> <text>Handling the finances of the patient;</text> </paragraph> <paragraph num="(b)"> <text>Arranging and contracting for services not covered by the patient agreement;</text> </paragraph> <paragraph num="(c)"> <text>Disposition of the patient’s property upon discharge or death of the patient;</text> </paragraph> <paragraph num="(d)"> <text>Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the patient’s funds;</text> </paragraph> <paragraph num="(e)"> <text>Fair and reasonable billing, payment, and credit policies;</text> </paragraph> <paragraph num="(f)"> <text>The procedures the hospice house will follow in the event the patient or representative can no longer pay for services provided for in the patient agreement or for services or care needed by the patient; and</text> </paragraph> <paragraph num="(g)"> <text>Terms governing the refund of any prepaid fees or charges in the event of a patient’s discharge from the hospice house or termination of the patient agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The hospice house shall maintain the patient agreement in the patient’s record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Patient Record."> <text>The hospice house shall:</text> <paragraph num="A."> <text>Maintain the privacy and confidentiality of a patient’s medical records;</text> </paragraph> <paragraph num="B."> <text>Release medical records or medical information about a patient only with the consent of the patient or patient’s representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Food."> <paragraph num="A."> <text>A patient’s food preferences shall be assessed at the time of admission. The assessment shall be maintained in the patient record.</text> </paragraph> <paragraph num="B."> <text>Patients shall be provided meals and snacks as requested.</text> </paragraph> <paragraph num="C."> <text>Patients shall be offered 3 meals and additional snacks during each 24-hour period, 7 days a week in accordance with their individual daily nutritional needs and preferences and consistent with their plan of care.</text> </paragraph> <paragraph num="D."> <text>Food that is prepared at the hospice house shall be prepared in accordance with all State and local sanitation and safe food handling requirements.</text> </paragraph> <paragraph num="E."> <text>Food preparation areas are to be maintained in accordance with all State and local sanitation and safe food handling requirements.</text> </paragraph> <paragraph num="F."> <text>Hospice house staff shall prepare or arrange for the provision of special diets consistent with the plan of care.</text> </paragraph> <paragraph num="G."> <text>Hospice house staff shall obtain food from sources that comply with all local laws and regulations relating to food, food processing, food handling, and food labeling.</text> </paragraph> <paragraph num="H."> <text>Hospice house staff shall protect food from contamination while being stored, prepared, displayed, served, or transported.</text> </paragraph> <paragraph num="I."> <text>Hospice house staff shall promptly discard the following:</text> <paragraph num="(1)"> <text>Spoiled food;</text> </paragraph> <paragraph num="(2)"> <text>Swelled, rusty, or leaky canned food; and</text> </paragraph> <paragraph num="(3)"> <text>Foods exposed to fire, smoke, or water damage.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The hospice house staff shall maintain kitchen surfaces, floors, walls, storage areas, equipment, appliances, and utensils in a clean and sanitary manner and in good repair.</text> </paragraph> <paragraph num="K."> <text>The hospice house staff shall provide refrigerator and freezer units operated in compliance with the manufacturer’s specifications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Personal Care Services."> <text>The hospice house staff shall provide all necessary personal care services to the patient in accordance with the plan of care and as desired by the patient.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Medication Management and Administration."> <paragraph num="A."> <text>All medications shall be administered consistent with applicable requirements of COMAR 10.27.11.</text> </paragraph> <paragraph num="B."> <text>Medications and treatments shall be administered consistent with current medical orders and using acceptable professional standards of practice.</text> </paragraph> <paragraph num="C."> <text>All medications shall be stored in a secure location, at proper temperature.</text> </paragraph> <paragraph num="D."> <text>Each patient’s medications shall be stored in the original dispensed container;</text> </paragraph> <paragraph num="E."> <text>Each patient shall receive the medications that have been specifically prescribed for that patient in the manner that has been ordered.</text> </paragraph> <paragraph num="F."> <text>The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any symptoms or pain that are not relieved by the current medications and other interventions.</text> </paragraph> <paragraph num="G."> <text>The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any undesired side effects, adverse drug reactions, or medication errors.</text> </paragraph> <paragraph num="H."> <text>The medication administration documentation required under this regulation shall be recorded by a staff member at the time that the patient takes or receives medications on a medication administration report. This documentation shall be maintained in the patient record and include at minimum:</text> <paragraph num="(1)"> <text>Name of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(4)"> <text>Allergies;</text> </paragraph> <paragraph num="(5)"> <text>Significant adverse drug reactions;</text> </paragraph> <paragraph num="(6)"> <text>Name of the medication;</text> </paragraph> <paragraph num="(7)"> <text>Reason for the medication;</text> </paragraph> <paragraph num="(8)"> <text>Dose;</text> </paragraph> <paragraph num="(9)"> <text>Authorized prescriber’s name;</text> </paragraph> <paragraph num="(10)"> <text>Date of issuance, and</text> </paragraph> <paragraph num="(11)"> <text>Directions for use.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Accounting for Narcotic and Controlled Drugs.</text> <paragraph num="(1)"> <text>The hospice house staff shall count and record controlled drugs at shift changes.</text> </paragraph> <paragraph num="(2)"> <text>All controlled substances and all medications with a high abuse potential in the hospice house’s location shall be maintained under a double lock system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Incident Reports."> <paragraph num="A."> <text>The staff of the hospice house shall complete an incident report in accordance with hospice policy within 24 hours of having knowledge that an incident has occurred.</text> </paragraph> <paragraph num="B."> <text>All incident reports shall include:</text> <paragraph num="(1)"> <text>Time, date, place, and individuals present;</text> </paragraph> <paragraph num="(2)"> <text>Complete description of the incident;</text> </paragraph> <paragraph num="(3)"> <text>Response of the staff at the time; and</text> </paragraph> <paragraph num="(4)"> <text>Follow up action, including notification to the:</text> <paragraph num="(a)"> <text>Patient’s primary hospice nurse or hospice nurse on call;</text> </paragraph> <paragraph num="(b)"> <text>Patient’s representative or family;</text> </paragraph> <paragraph num="(c)"> <text>Patient’s attending physician or nurse practitioner;</text> </paragraph> <paragraph num="(d)"> <text>Hospice medical director; and</text> </paragraph> <paragraph num="(e)"> <text>Licensing or law enforcement authorities, when appropriate.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Relocation and Discharges."> <paragraph num="A."> <text>Relocation within the Facility. The hospice house may not relocate a patient within the facility except in accordance with the terms and conditions of the residential agreement.</text> </paragraph> <paragraph num="B."> <text>Discharge.</text> <paragraph num="(1)"> <text>Discharge of a patient without the consent of the patient or the patient’s representative shall be in accordance with the residential agreement.</text> </paragraph> <paragraph num="(2)"> <text>When the patient is discharged or transferred to another facility, the hospice house shall provide to the receiving facility all information that is required to ensure that continuity of care and services is maintained.</text> </paragraph> <paragraph num="(3)"> <text>Within 30 days of the date of discharge, the hospice house shall:</text> <paragraph num="(a)"> <text>Give the patient or patient’s representative a final statement of account and refunds due; and</text> </paragraph> <paragraph num="(b)"> <text>Return any money, property, or valuables held in trust or custody by the hospice house.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Patient’s Rights."> <paragraph num="A."> <text>In addition to all other rights as a hospice patient, the patient residing in a hospice house has the right to:</text> <paragraph num="(1)"> <text>Privacy, including the right to have a staff member knock on the patient’s door before entering;</text> </paragraph> <paragraph num="(2)"> <text>Be free from mental abuse, verbal abuse, sexual abuse, physical abuse, neglect, involuntary seclusion, and exploitation;</text> </paragraph> <paragraph num="(3)"> <text>Be free from physical and chemical restraints;</text> </paragraph> <paragraph num="(4)"> <text>Manage personal financial affairs;</text> </paragraph> <paragraph num="(5)"> <text>Maintain legal counsel;</text> </paragraph> <paragraph num="(6)"> <text>Attend or not attend religious services as the patient chooses, and receive visits from members of the clergy;</text> </paragraph> <paragraph num="(7)"> <text>Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the hospice house’s security policy;</text> </paragraph> <paragraph num="(8)"> <text>Retain personal clothing and possessions as space permits with the understanding that the hospice house may limit the number of personal possessions retained at the facility for the health and safety of other patients;</text> </paragraph> <paragraph num="(9)"> <text>Meet or visit privately with any individual the patient chooses in accordance with patient and facility safety; and</text> </paragraph> <paragraph num="(10)"> <text>Have reasonable access to the private use of a telephone within the facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Patient’s Rights. The hospice house shall:</text> <paragraph num="(1)"> <text>Place a copy of the patient’s rights as set forth in this regulation, in a conspicuous location, plainly visible and easily read by patients, staff, and visitors; and</text> </paragraph> <paragraph num="(2)"> <text>Provide a copy to the patient and patient’s representative on admission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Abuse, Neglect, and Exploitation."> <paragraph num="A."> <text>The hospice house shall develop and implement policies and procedures prohibiting abuse, neglect, and exploitation of hospice house patients.</text> </paragraph> <paragraph num="B."> <text>Reports of Abuse, Neglect, or Exploitation. An employee of the hospice house who believes that a patient has been subjected to abuse, neglect, or exploitation shall report the alleged abuse, neglect, or exploitation within 24 hours to:</text> <paragraph num="(1)"> <text>The appropriate local Department of Social Services, Adult Protective Services office, or Child Protective Services; and</text> </paragraph> <paragraph num="(2)"> <text>One of the following:</text> <paragraph num="(a)"> <text>A local law enforcement agency; or</text> </paragraph> <paragraph num="(b)"> <text>The Office of Health Care Quality.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Investigations. The hospice house shall:</text> <paragraph num="(1)"> <text>Thoroughly investigate all allegations of abuse, neglect, or exploitation and maintain on-site written documentation of the investigation; and</text> </paragraph> <paragraph num="(2)"> <text>Take appropriate action to prevent further incidents of abuse, neglect, or exploitation while the investigation is in progress.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Immunity from Civil Liability; An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>Notice. The hospice house shall post signs that set forth the reporting requirements stated in §B of this regulation, conspicuously in the employee and public areas of the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Restraint or Seclusion."> <paragraph num="A."> <text>A hospice house shall develop a policy and procedure related to restraint and seclusion.</text> </paragraph> <paragraph num="B."> <text>Relevant staff shall be trained in accordance with the facility’s policy and procedure related to restraint and seclusion.</text> </paragraph> <paragraph num="C."> <text>Patients have the right to be free from restraint or seclusion of any form which are imposed as a means of coercion, discipline, convenience, or retaliation by staff.</text> </paragraph> <paragraph num="D."> <text>Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and shall be discontinued at the earliest possible time.</text> </paragraph> <paragraph num="E."> <text>The type or technique of restraint or seclusion used shall be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm.</text> </paragraph> <paragraph num="F."> <text>The use of restraint or seclusion shall be:</text> <paragraph num="(1)"> <text>In accordance with a written modification to the patient’s plan of care; and</text> </paragraph> <paragraph num="(2)"> <text>Implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospice policy in accordance with applicable laws.</text> </paragraph> </paragraph> <paragraph num="G."> <text>All restraints shall be ordered by a physician and shall specify:</text> <paragraph num="(1)"> <text>The purpose of the restraint;</text> </paragraph> <paragraph num="(2)"> <text>The type of restraint to be used; and</text> </paragraph> <paragraph num="(3)"> <text>The length of time the restraint shall be used.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Restraint and seclusion orders may not be on an as-needed basis.</text> </paragraph> <paragraph num="I."> <text>A patient may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity.</text> </paragraph> <paragraph num="J."> <text>The patient’s primary hospice nurse or hospice nurse on call and hospice medical director or physician designee shall be consulted as soon as possible after the implementation of any restraint or seclusion to, as applicable:</text> <paragraph num="(1)"> <text>Review and modify the plan of care; and</text> </paragraph> <paragraph num="(2)"> <text>Determine if the hospice house is an appropriate setting for the patient at this time.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The program shall notify the patient’s family or the patient’s representative each time a restraint is used.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="General Physical Plant Requirements."> <paragraph num="A."> <text>The facility, which includes buildings, common areas, and exterior grounds, shall be kept:</text> <paragraph num="(1)"> <text>In good repair;</text> </paragraph> <paragraph num="(2)"> <text>Clean;</text> </paragraph> <paragraph num="(3)"> <text>Free of any object, material, or condition that may create a:</text> <paragraph num="(a)"> <text>Health hazard, accident, or fire; or</text> </paragraph> <paragraph num="(b)"> <text>Public nuisance; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Free of insect infestations and rodents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospice house shall provide adequate storage space, which is protected from the elements, for:</text> <paragraph num="(1)"> <text>Excess supplies;</text> </paragraph> <paragraph num="(2)"> <text>Some personal possessions of patients; and</text> </paragraph> <paragraph num="(3)"> <text>Any other items in the patient’s room.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Water Supply."> <paragraph num="A."> <text>Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the hospice house is located or a private certified vendor.</text> </paragraph> <paragraph num="B."> <text>Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility.</text> </paragraph> <paragraph num="C."> <text>Hot Water Temperature. Hot water accessible to patients shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120ºF and a minimum temperature of 110ºF at the fixture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Sewage Disposal."> <text>The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located.</text> </regulation> <regulation prefix="Regulation" num=".22" heading="Security."> <text>The facility shall have policies and procedures in place to provide a secure environment for the patient, family, and staff.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Assist Rails."> <paragraph num="A."> <text>The hospice house shall provide assist rails in stairways used by patients and for all toilets, showers, and bathtubs used by patients.</text> </paragraph> <paragraph num="B."> <text>The hospice house with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Emergency Preparedness."> <paragraph num="A."> <text>The facility shall be constructed consistent with:</text> <paragraph num="(1)"> <text>All applicable local fire and building codes; and</text> </paragraph> <paragraph num="(2)"> <text>The Life Safety Code, NFPA 101, including Chapter 24 of NFPA 101.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hand Extinguishers. Fire extinguishers shall be located on each floor and adjacent to, or in, special hazard areas, such as furnace rooms, boiler rooms, kitchens, or laundries. Fire extinguishers shall be of standard and approved types, and installed and maintained to be conveniently available for use at all times. The hospice house shall properly instruct staff in the use of fire extinguishers.</text> </paragraph> <paragraph num="C."> <text>Emergency Plan.</text> <paragraph num="(1)"> <text>The hospice house shall develop an emergency plan that includes procedures that will be followed before, during, and after an emergency. The emergency plan shall address:</text> <paragraph num="(a)"> <text>The evacuation, transportation, or shelter in-place of patients;</text> </paragraph> <paragraph num="(b)"> <text>Notification to families, staff, and the Office of Health Care Quality regarding the action that will be taken concerning the safety and well-being of the patients;</text> </paragraph> <paragraph num="(c)"> <text>Staff coverage, organization, and assignment of responsibilities; and</text> </paragraph> <paragraph num="(d)"> <text>The continuity of operation, including:</text> <paragraph num="(i)"> <text>Procuring essential goods, equipment, and services; and</text> </paragraph> <paragraph num="(ii)"> <text>Relocation to alternate facilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Hospice House shall have a signed agreement with the facility that will house the program’s patients during an emergency evacuation.</text> </paragraph> <paragraph num="(3)"> <text>Upon request, the hospice house shall provide access to its emergency plan to local organizations for emergency management and for purposes of coordinating local emergency planning.</text> </paragraph> <paragraph num="(4)"> <text>The hospice house shall prepare a summary of its evacuation procedures to provide to the patient, family member, or legal representative upon request. The summary shall, at a minimum:</text> <paragraph num="(a)"> <text>List means of transportation to be used in the event of evacuation;</text> </paragraph> <paragraph num="(b)"> <text>List alternative facilities to be used in the event of evacuation;</text> </paragraph> <paragraph num="(c)"> <text>Describe means of communication with family members and legal representatives; and</text> </paragraph> <paragraph num="(d)"> <text>Describe the role of the patient, family member, or legal representative in the event of evacuation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor.</text> </paragraph> <paragraph num="E."> <text>Emergency Electrical Power Generator.</text> <paragraph num="(1)"> <text>Generator Required. A hospice house with 6 or more beds shall have an emergency electrical power generator on the premises.</text> </paragraph> <paragraph num="(2)"> <text>Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall:</text> <paragraph num="(a)"> <text>Be activated immediately when normal electrical service fails to operate;</text> </paragraph> <paragraph num="(b)"> <text>Come to full speed and load acceptance within 10 seconds; and</text> </paragraph> <paragraph num="(c)"> <text>Have the capability of 48 hours of operation from fuel stored on-site.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Test of Emergency Power System.</text> <paragraph num="(1)"> <text>The program shall test the emergency power system once each month.</text> </paragraph> <paragraph num="(2)"> <text>During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load.</text> </paragraph> <paragraph num="(3)"> <text>Results of the test shall be recorded in a permanent log book that is maintained for that purpose.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The emergency power system shall provide lighting in the following areas of the facility:</text> <paragraph num="(1)"> <text>Areas of egress and protection as required by COMAR 29.06.01 State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission in COMAR 29.06.01;</text> </paragraph> <paragraph num="(2)"> <text>Nurses’ station;</text> </paragraph> <paragraph num="(3)"> <text>Medication area;</text> </paragraph> <paragraph num="(4)"> <text>An area for emergency telephone use;</text> </paragraph> <paragraph num="(5)"> <text>Boiler or mechanical room;</text> </paragraph> <paragraph num="(6)"> <text>Kitchen;</text> </paragraph> <paragraph num="(7)"> <text>Emergency generator location and switch gear location;</text> </paragraph> <paragraph num="(8)"> <text>If applicable, elevator, if operable on emergency power;</text> </paragraph> <paragraph num="(9)"> <text>If applicable, areas where life-support equipment is used;</text> </paragraph> <paragraph num="(10)"> <text>If applicable, common areas or areas of refuge; and</text> </paragraph> <paragraph num="(11)"> <text>If applicable, toilet rooms of common areas or areas of refuge.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Emergency electrical power shall be provided for the following, if applicable:</text> <paragraph num="(1)"> <text>Nurses’ call system;</text> </paragraph> <paragraph num="(2)"> <text>At least one telephone in order to make and receive calls;</text> </paragraph> <paragraph num="(3)"> <text>Fire pump;</text> </paragraph> <paragraph num="(4)"> <text>Sewerage pump and sump pump;</text> </paragraph> <paragraph num="(5)"> <text>If applicable, an elevator, if required, for evacuation purposes;</text> </paragraph> <paragraph num="(6)"> <text>If necessary, heating equipment needed to maintain a minimum temperature of 70ºF (24ºC);</text> </paragraph> <paragraph num="(7)"> <text>If applicable, life support equipment; and</text> </paragraph> <paragraph num="(8)"> <text>Nonflammable medical gas systems.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all patient rooms and toilet rooms, the program shall provide common areas or areas of refuge for all patients. The areas shall meet the following requirements:</text> <paragraph num="(1)"> <text>The common area or areas of refuge shall maintain a minimum temperature of 70ºF (24ºC); and</text> </paragraph> <paragraph num="(2)"> <text>Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Orientation. The hospice house shall:</text> <paragraph num="(1)"> <text>Orient staff to the emergency plan and to their individual responsibilities within 24 hours of the commencement of job duties; and</text> </paragraph> <paragraph num="(2)"> <text>Document completion of the orientation in the staff member’s personnel file through the signature of the employee.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Drills.</text> <paragraph num="(1)"> <text>Fire Drills. The hospice house shall:</text> <paragraph num="(a)"> <text>Conduct fire drills at least quarterly on all shifts; and</text> </paragraph> <paragraph num="(b)"> <text>Document completion of each drill.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation. The hospice house shall:</text> <paragraph num="(a)"> <text>Have the documentation referenced in §K(1)(b) of this regulation signed by all staff who participated in the drill; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>Disaster Drill or Training Session.</text> <paragraph num="(1)"> <text>The hospice house shall:</text> <paragraph num="(a)"> <text>Conduct an annual disaster drill or training session, other than a fire drill, on all shifts; and</text> </paragraph> <paragraph num="(b)"> <text>Document completion of each disaster drill or training session.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation. The hospice house shall:</text> <paragraph num="(a)"> <text>Have the documentation referenced in §L(1)(b) of this regulation signed by all staff who participated in the drill or training; and</text> </paragraph> <paragraph num="(b)"> <text>Keep the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Smoking."> <text>The hospice house shall prohibit indoor smoking in accordance with COMAR 10.19.04 and COMAR 10.12.27.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Common Use Areas."> <paragraph num="A."> <text>Common Areas. The hospice house shall provide common areas for the use of patients and families. The common areas shall be of a size and furnished to accommodate the number of family members reasonably expected to attend the number of patients provided for by the hospice house capacity.</text> </paragraph> <paragraph num="B."> <text>Public Toilets. The hospice house shall provide public restrooms that are sufficient in number, and appropriately located, to serve family members and visitors.</text> </paragraph> <paragraph num="C."> <text>Dining Area. The hospice house shall provide a well-lit, adequately ventilated, and appropriately furnished dining area for the use of patients, families, and visitors.</text> </paragraph> <paragraph num="D."> <text>Kitchen. The hospice house shall have a kitchen that has adequate:</text> <paragraph num="(1)"> <text>Storage, refrigerator, and freezer space for perishable and nonperishable foods;</text> </paragraph> <paragraph num="(2)"> <text>Food preparation area or areas with cleanable surfaces;</text> </paragraph> <paragraph num="(3)"> <text>Space and equipment to wash, sanitize, and store utensils;</text> </paragraph> <paragraph num="(4)"> <text>Space to store and clean garbage cans within or outside the kitchen;</text> </paragraph> <paragraph num="(5)"> <text>Ice making capabilities; and</text> </paragraph> <paragraph num="(6)"> <text>Equipment for the preparation of food.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Patients’ Rooms and Furnishings."> <paragraph num="A."> <text>Patient rooms shall be of a size and with furnishings adequate for the hospice residence staff to provide care of the patient as required by the plan of care.</text> </paragraph> <paragraph num="B."> <text>Patient rooms shall provide accommodation for one family member to remain with the patient through the night.</text> </paragraph> <paragraph num="C."> <text>Patient rooms shall be for the private use of the assigned patient or patients.</text> </paragraph> <paragraph num="D."> <text>If a patient in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the hospice house shall furnish them.</text> </paragraph> <paragraph num="E."> <text>The hospice house shall provide adequate closet or wardrobe space, conveniently located to allow each patient to keep personal items.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Bathrooms for Patients."> <paragraph num="A."> <text>Toilets. The hospice house shall provide toilets in a separate room or compartment with latching hardware for privacy.</text> </paragraph> <paragraph num="B."> <text>Lavatories. Buildings with one to eight occupants shall have a minimum ratio of one lavatory to four occupants. Buildings with nine or more occupants shall have a minimum ratio of one lavatory to four occupants and a minimum of one lavatory for each floor on which a patient room is located.</text> </paragraph> <paragraph num="C."> <text>Bathtubs or Showers. The hospice house shall provide patients with bathtubs or showers that are enclosed in a separate room or compartment that ensures privacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Illumination."> <paragraph num="A."> <text>The hospice house shall provide sufficient light to meet the patient’s needs.</text> </paragraph> <paragraph num="B."> <text>Common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, shall have sufficient artificial lighting to prevent accidents and promote efficient service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Heating, Ventilation, and Air Conditioning."> <paragraph num="A."> <text>The hospice house may not use space heaters unless approved by the State or local fire authorities.</text> </paragraph> <paragraph num="B."> <text>Minimum Temperature. The facility shall have a system that provides in areas used by patients a minimum temperature of 70ºF in cold weather and a maximum temperature of 80ºF in hot weather.</text> </paragraph> <paragraph num="C."> <text>Temperature Control. The hospice house shall provide for each resident's room:</text> <paragraph num="(1)"> <text>A thermostat; or</text> </paragraph> <paragraph num="(2)"> <text>An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospice house shall ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors. The hospice house shall provide forced mechanical exhaust ventilation or an approved equivalent for:</text> <paragraph num="(1)"> <text>All bathing compartments;</text> </paragraph> <paragraph num="(2)"> <text>Toilet rooms;</text> </paragraph> <paragraph num="(3)"> <text>Any area used for toileting; and</text> </paragraph> <paragraph num="(4)"> <text>Soiled utility rooms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Laundry."> <paragraph num="A."> <text>The hospice house shall furnish laundry service, either on-site or off-site.</text> </paragraph> <paragraph num="B."> <text>The hospice house shall ensure that the laundry is:</text> <paragraph num="(1)"> <text>Adequate to meet the needs of the patients;</text> </paragraph> <paragraph num="(2)"> <text>Processed and handled in a manner to prevent the spread of infection; and</text> </paragraph> <paragraph num="(3)"> <text>Adequately sanitized by the use of sufficient hot water or appropriate chemical representatives, or a combination of both.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospice house shall ensure that patient and facility laundry is washed and dried separately.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise agreed by the program and the patient, dry cleaning services are not considered part of laundry services in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Infection Control."> <paragraph num="A."> <text>The hospice house shall maintain an infection control program that protects patients, staff, and others by preventing and controlling infections and communicable diseases.</text> </paragraph> <paragraph num="B."> <text>The hospice house shall follow accepted standards of practice to prevent the transmission of infections and communicable diseases, including the use of standard precautions.</text> </paragraph> <paragraph num="C."> <text>The infection control program shall include the following:</text> <paragraph num="(1)"> <text>Education of employees, contracted providers, patients, and family members about infection control, including their role in preventing the spread of infection and communicable diseases through daily activities;</text> </paragraph> <paragraph num="(2)"> <text>Techniques for hand washing, respiratory protections, asepsis, as well as other means for limiting the spread of contagion;</text> </paragraph> <paragraph num="(3)"> <text>Measures for the:</text> <paragraph num="(a)"> <text>Screening and evaluation of health care workers, including all hospice staff, volunteers, and contract workers, including agency nurses and housekeeping staff for communicable diseases; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluation of staff and volunteers exposed to patients with non-treated communicable diseases; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Monitoring staff for compliance with hospice policies and procedures related to infection control.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Pet Visitation."> <paragraph num="A."> <text>A hospice house shall have a policy and procedure related to pet visitations.</text> </paragraph> <paragraph num="B."> <text>Visiting dogs and cats shall have proof of a current rabies vaccination on file.</text> </paragraph> <paragraph num="C."> <text>If another patient has an allergy or a respiratory condition that is aggravated by an animal, the animal shall remain outside of areas where that resident may be.</text> </paragraph> <paragraph num="D."> <text>The hospice house has the right to restrict any pet from the hospice house.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-903, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 10, 2013 (40:11 Md. R. 975)</annotation> </annotations> </chapter> </subtitle> <subtitle num="08" heading="Health Facilities Grants"> <chapter num="01" heading="Construction Funds for Public and Nonprofit Nursing Homes"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations govern the administration of construction funds for public and nonprofit nursing homes made available by the Nursing Home Loan Act of 1990, and subsequent similar Loan Acts. In addition, these regulations govern the administration of the assurances, residual requirements, and the State's right of recovery for those applicants that received construction funds under the Nursing Home Loan Acts of 1972, 1975, 1977, 1978, 1980, and 1985.</text> </paragraph> <paragraph num="B."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist applicants for the construction, expansion, renovation, and equipping of nursing home eligible under the Nursing Home Loan Act of 1990 and subsequent similar Loan Acts in accordance with these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Repealed." /> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a county, municipal corporation or nonprofit organization that seeks to obtain State grant funds under the Loan Acts.</text> </paragraph> <paragraph num="(2)"> <text>“Certificate of Need” means a certificate issued by the Maryland Health Care Commission under Health-General Article, §19-101 et seq., Annotated Code of Maryland, for a health care project.</text> </paragraph> <paragraph num="(3)"> <text>Construction.</text> <paragraph num="(a)"> <text>“Construction” means construction of new buildings or additions to existing buildings and initial capital equipment, including plans, specifications, site improvements, surveys, and applicable engineers' and architects' fees.</text> </paragraph> <paragraph num="(b)"> <text>“Construction” does not include the cost of land acquisition or the cost of off-site improvements.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Facility” means a nursing home that is wholly owned by and operated under the authority of a:</text> <paragraph num="(a)"> <text>County or municipal corporation; or</text> </paragraph> <paragraph num="(b)"> <text>Nonprofit organization.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Grantee” means a county, a municipal corporation, or a nonprofit organization for which State grant funds under the Loan Act are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(7)"> <text>Initial Capital Equipment.</text> <paragraph num="(a)"> <text>“Initial capital equipment” means items which:</text> <paragraph num="(i)"> <text>Are necessary to furnish and initially operate a facility;</text> </paragraph> <paragraph num="(ii)"> <text>With normal maintenance, have a life expectancy of at least 15 years; and</text> </paragraph> <paragraph num="(iii)"> <text>Are of durable construction.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Initial capital equipment” does not include items which:</text> <paragraph num="(i)"> <text>Could be easily lost, damaged, or destroyed during normal usage;</text> </paragraph> <paragraph num="(ii)"> <text>Could be easily stolen;</text> </paragraph> <paragraph num="(iii)"> <text>Are likely to be technically obsolescent within 15 years; or</text> </paragraph> <paragraph num="(iv)"> <text>Are intended to replace similar items already on hand.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Loan Act” means:</text> <paragraph num="(a)"> <text>The Nursing Home Loan Act of 1972, Chapter 119, Acts of 1972;</text> </paragraph> <paragraph num="(b)"> <text>The Nursing Home Loan Act of 1975, Chapter 656, Acts of 1975;</text> </paragraph> <paragraph num="(c)"> <text>The Nursing Home Loan Act of 1977, Chapter 703, Acts of 1977;</text> </paragraph> <paragraph num="(d)"> <text>The Nursing Home Loan Act of 1978, Chapter 904, Acts of 1978;</text> </paragraph> <paragraph num="(e)"> <text>The Nursing Home Loan Act of 1980, Chapter 713, Acts of 1980;</text> </paragraph> <paragraph num="(f)"> <text>The Nursing Home Loan Act of 1985, Chapter 304, Acts of 1985;</text> </paragraph> <paragraph num="(g)"> <text>The Nursing Home Loan Act of 1990, Chapter 228, Acts of 1990; and</text> </paragraph> <paragraph num="(h)"> <text>All subsequent similar legislation.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Nonprofit nursing home” means a nursing home which is or will be wholly owned by and operated under the authority of a nonprofit organization.</text> </paragraph> <paragraph num="(10)"> <text>“Nonprofit organization” means:</text> <paragraph num="(a)"> <text>A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as a nonprofit; and</text> </paragraph> <paragraph num="(b)"> <text>That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the nursing home, the purchase of equipment to be used in the nursing home, or the expansion of the nursing home.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Nursing home” means a comprehensive care facility as set forth in COMAR 10.07.02.</text> </paragraph> <paragraph num="(12)"> <text>“Nursing Home Loan Act of 1972” means Chapter 119, Acts of 1972.</text> </paragraph> <paragraph num="(13)"> <text>“Nursing Home Loan Act of 1975” means Chapter 656, Acts of 1975.</text> </paragraph> <paragraph num="(14)"> <text>“Nursing Home Loan Act of 1977” means Chapter 703, Acts of 1977.</text> </paragraph> <paragraph num="(15)"> <text>“Nursing Home Loan Act of 1978” means Chapter 904, Acts of 1978.</text> </paragraph> <paragraph num="(16)"> <text>“Nursing Home Loan Act of 1980” means Chapter 713, Acts of 1980.</text> </paragraph> <paragraph num="(17)"> <text>“Nursing Home Loan Act of 1985” means Chapter 304, Acts of 1985.</text> </paragraph> <paragraph num="(18)"> <text>“Nursing Home Loan Act of 1990” means Chapter 228, Acts of 1990.</text> </paragraph> <paragraph num="(19)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(20)"> <text>“Public nursing home” means a nursing home that is wholly owned and operated under the authority of a county or a municipal corporation.</text> </paragraph> <paragraph num="(21)"> <text>“Renovation” means the work required to restore or modernize, or both, most or all of a nursing home.</text> </paragraph> <paragraph num="(22)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(23)"> <text>“Wholly owned” includes leased property, if the project proposed by the applicant includes:</text> <paragraph num="(a)"> <text>A lease agreement with the State for a State-owned building or State-owned property; or</text> </paragraph> <paragraph num="(b)"> <text>A lease agreement:</text> <paragraph num="(i)"> <text>Which is for a minimum of 15 years following the project completion or extends the right of purchase to the lessee, and</text> </paragraph> <paragraph num="(ii)"> <text>In which the lessor consents to the recording of a notice of the State's right of recovery, under the Nursing Home Loan Act of 1990, Section 1, Paragraph (9), in the land records of the county or Baltimore City in which the facility is located.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility of Applicant for State Funds."> <paragraph num="A."> <text>To be eligible for State funds under the Loan Act of 1990 and subsequent similar Loan Acts, an applicant:</text> <paragraph num="(1)"> <text>Shall be a county, a municipal corporation, or a nonprofit organization;</text> </paragraph> <paragraph num="(2)"> <text>That is a nonprofit organization shall verify its nonprofit status to the Department through its articles of incorporation, or appropriate documentation from the Internal Revenue Service classifying the organization as nonprofit;</text> </paragraph> <paragraph num="(3)"> <text>Shall have a Certificate of Need from the Maryland Health Care Commission, if a Certificate of Need is required for the project;</text> </paragraph> <paragraph num="(4)"> <text>Shall be eligible for certification to participate in the Medical Assistance Program and shall agree to participate;</text> </paragraph> <paragraph num="(5)"> <text>Shall certify that the nursing home meets the requirements of 42 U.S.C. §12101 et seq.; and</text> </paragraph> <paragraph num="(6)"> <text>Shall be approved by the Secretary to receive a grant award.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Loan Act of 1990 or this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Priority of Eligible Projects."> <text>The Department shall determine the priority of applicants for State grant funds under the Loan Act of 1990 and subsequent similar Acts after consideration of:</text> <paragraph num="A."> <text>All eligible applications;</text> </paragraph> <paragraph num="B."> <text>The availability of unallocated State funds at the time an application is received; and</text> </paragraph> <paragraph num="C."> <text>Priorities established by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall direct an application for State grant funds authorized by the Loan Act of 1990 and subsequent similar Loan Acts to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> <paragraph num="B."> <text>The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04.</text> </paragraph> <paragraph num="C."> <text>At the time of filing the application required by §A of this regulation, the applicant shall file a written statement with the Department containing the following material:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>Admission policies for the nursing home;</text> </paragraph> <paragraph num="(3)"> <text>Agreement to admit patients without discrimination on the basis of race, religion, national origin, creed, or color;</text> </paragraph> <paragraph num="(4)"> <text>The number of personnel employed or to be employed at the nursing home, by occupation, and all perquisites, salaries, and any other funds paid or to be paid to these personnel;</text> </paragraph> <paragraph num="(5)"> <text>Expenses incurred or to be incurred in operating the nursing home;</text> </paragraph> <paragraph num="(6)"> <text>The schedule of rates charged or to be charged for services rendered;</text> </paragraph> <paragraph num="(7)"> <text>If the nursing home is operating, a current, certified profit-and-loss statement and balance sheet for the most current fiscal year; and</text> </paragraph> <paragraph num="(8)"> <text>If the applicant is applying for poverty funding under Regulation .09D of this chapter, an agreement that the majority of the individuals served by the applicant shall be poverty-designated clients, as defined in Regulation .09D of this chapter, for each year for a period of 15 years following the completion of the nursing home.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the application meets all pertinent criteria, the Secretary, in the Secretary's discretion, may approve that application and, if approved, shall recommend the application to the Board of Public Works, together with a written report stating that:</text> <paragraph num="(1)"> <text>Notice and information have been provided to the State Clearinghouse;</text> </paragraph> <paragraph num="(2)"> <text>The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority; and</text> </paragraph> <paragraph num="(3)"> <text>The Secretary recommends that the Board of Public Works make available to the applicant State grant funds.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Assurances from Grantee."> <paragraph num="A."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, and 1978: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Department and the Board of Public Works.</text> </paragraph> <paragraph num="B."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Act of 1980: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Secretary.</text> </paragraph> <paragraph num="C."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1985, 1990, and subsequent similar Acts: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Board of Public Works.</text> </paragraph> <paragraph num="D."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Acts: The grantee shall operate and maintain the completed nursing home in accordance with all applicable State and federal regulations and standards for comprehensive care facilities.</text> </paragraph> <paragraph num="E."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, and 1978: Patients shall be admitted without discrimination on the basis of race, creed, color, sex, national origin, age, marital status, or handicap.</text> </paragraph> <paragraph num="F."> <text>The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1978, 1980, 1985, 1990, and subsequent similar Acts: The nursing home shall apply the same admissions standards to all persons. A Medicaid recipient shall receive the same consideration as any other candidate for admission. Quotas by class of payor are not allowed.</text> </paragraph> <paragraph num="G."> <text>For those grantees receiving State funds under the Loan Acts of 1972, 1975, 1977, and 1978, the grantee shall agree to provide uncompensated care annually at one of the following levels:</text> <paragraph num="(1)"> <text>A grantee may advise the State that it does not intend to deny an individual admission to the facility because of the individual's inability to pay;</text> </paragraph> <paragraph num="(2)"> <text>A grantee may advise the State that its level of uncompensated care for individuals unable to pay shall be equal to 10 percent annually of all State funds received under the applicable Nursing Home Loan Act;</text> </paragraph> <paragraph num="(3)"> <text>A grantee may advise that the proposed level of uncompensated care shall be equal to 3 percent of the difference between the facility's annual operating cost and the sum of the annual Medicare and Medicaid reimbursements.</text> </paragraph> </paragraph> <paragraph num="H."> <text>For those grantees that received State funds under the Loan Act of 1980, the grantee shall agree to provide uncompensated care annually at one of the following levels:</text> <paragraph num="(1)"> <text>The grantee shall advise the Department that its level of uncompensated care for individuals unable to pay shall be equal to 10 percent annually of all State funds received under the Nursing Home Loan Act of 1980;</text> </paragraph> <paragraph num="(2)"> <text>The grantee shall advise the Department that the proposed level of uncompensated care shall be equal to 3 percent of the difference between the facility's annual operating cost and the sum of the annual Medicare and Medicaid reimbursements.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the grantee finds that the options in §G or H of this regulation are not feasible, the grantee shall propose an alternate option to the Department. This alternate proposal shall be reviewed by the Secretary in consultation with the grantee, and a determination shall be made as to its acceptability.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For a period of 15 years following the completion of a project involving these grant funds, a grantee that received funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Loan Acts shall file written statements annually with the Department containing the following material:</text> <paragraph num="(a)"> <text>The number of personnel employed at the nursing home, by occupation, and all perquisites, salaries, and any other funds currently paid to these personnel;</text> </paragraph> <paragraph num="(b)"> <text>Fees or retainers paid directly or under contract to persons rendering services at the nursing home;</text> </paragraph> <paragraph num="(c)"> <text>A current, certified, audited profit-and-loss statement and balance sheet for the nursing home;</text> </paragraph> <paragraph num="(d)"> <text>Rates and fees charged for services at the nursing home;</text> </paragraph> <paragraph num="(e)"> <text>Gifts or endowments received during the current year;</text> </paragraph> <paragraph num="(f)"> <text>Patient days of service rendered, showing separately the days of service rendered to patients in the following classifications:</text> <paragraph num="(i)"> <text>Self-paying;</text> </paragraph> <paragraph num="(ii)"> <text>Below cost;</text> </paragraph> <paragraph num="(iii)"> <text>Medicare;</text> </paragraph> <paragraph num="(iv)"> <text>Medicaid;</text> </paragraph> <paragraph num="(v)"> <text>Public assistance; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a period of 15 years following the completion of a project that receives poverty funding under Regulation .09D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty clients defined in Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>The applicant shall provide builders’ risk insurance during the entire period of project construction or renovation as follows:</text> <paragraph num="(a)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall be endorsed to protect the State's interest in the nursing home;</text> </paragraph> <paragraph num="(c)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the nursing home; and</text> </paragraph> <paragraph num="(d)"> <text>The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon completion of a project, the grantee shall maintain for a period of 15 years all-risk insurance coverage as follows:</text> <paragraph num="(a)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the nursing home;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>The policy shall be endorsed to protect the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Notification of cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; and</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A grantee receiving grant funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Loan Acts, shall make available business records of the nursing home for verification by representatives of the Department or its designated agents during the entire period of work on the project and for a period of 15 years after the project has been completed.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion, and Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation by the Maryland legislature.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may grant a request by the applicant for a change in the manner or time of encumbrance of funds, including an extension of time, for good cause.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) of this regulation, and a notice of the right of recovery is recorded in the land records of the political jurisdiction in which the property is located.</text> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with §§A, B, and C of this regulation, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under a Loan Act; and</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>The provisions of these regulations apply to applicants for grants under the Loan Act of 1990 and subsequent similar Loan Acts.</text> </paragraph> <paragraph num="B."> <text>Use of Federal Grants. Federal grants available for a project shall be applied first to the cost of construction, expansion, renovation, and equipping of an eligible nursing home, before a State grant is expended.</text> </paragraph> <paragraph num="C."> <text>Limits on State Grant.</text> <paragraph num="(1)"> <text>For a project without federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of eligible costs, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of eligible costs, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a project with federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of the eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may not be eligible for retroactive participation in the cost of acquisition, construction, renovation, or purchase of equipment.</text> </paragraph> <paragraph num="(4)"> <text>The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Poverty Funding. An applicant is eligible for poverty funding for a nursing home, if the majority of individuals served by the nursing home:</text> <paragraph num="(1)"> <text>Are certified by a local department of social services as eligible for the Disability Assistance and Loan Program (DALP) or Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(3)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Application Costs.</text> <paragraph num="(1)"> <text>An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings.</text> </paragraph> <paragraph num="(2)"> <text>If the project is recommended for funding by the Department, the Department shall review the costs expended under §E(1) of this regulation, and may recommend those costs to the Board of Public Works for inclusion in the grant award.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Matching Funds.</text> <paragraph num="(1)"> <text>An applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise.</text> </paragraph> <paragraph num="(3)"> <text>The Department may not consider real or personal property, in-kind contributions, or funds expended before the date a grant award is approved by the Board of Public Works as matching funds.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Prohibition Against Use of Funds for Religious Purposes.</text> <paragraph num="(1)"> <text>A grantee may not use any portion of the proceeds of a State grant:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction; or</text> </paragraph> <paragraph num="(b)"> <text>In connection with the design or construction of any building used or to be used as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been or is being used for a purpose prohibited by the Loan Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Right of Recovery."> <paragraph num="A."> <text>In the event of default under the terms of the Loan Acts and this chapter, nursing homes which received funds from the Loan Acts of 1975, 1977, 1978, 1980, 1985, 1990, and all subsequent Loan Acts are subject to the State's right of recovery as set forth in the Loan Acts.</text> </paragraph> <paragraph num="B."> <text>Grant funds received by nursing homes from the Loan Act of 1972 shall be recovered proportionably and in the same manner as federal funds are recovered under the provisions of Subchapter IV—Construction of Hospitals and Other Facilities, 42 U.S.C. §291 et seq., as set forth in that Loan Act.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), Annotated Code of Maryland; Ch. 228, Acts of 1990</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted as an emergency provision effective November 13, 1985 (12:25 Md. R. 2469); emergency status expired March 13, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted as an emergency provision effective April 2, 1986 (13:9 Md. R. 1019) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted effective July 12, 1986 (13:13 Md. R. 1491)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.08.19 to 10.08.01 and amended effective February 23, 1987 (14:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .03—.10 amended effective December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Annotation: The following chapters were originally adopted to govern the administration of construction funds for public and non-profit nursing homes. These chapters were repealed effective February 23, 1987 (14:4 Md. R. 417) and replaced by the current COMAR 10.08.01:</annotation> <annotation type="History" subtype="Administrative History">10.08.01 (1968) effective February 17, 1969; amended effective June 30, 1969 and June 11, 1975 (2:13 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">10.08.02 (1972) effective April 5, 1973; amended effective June 11, 1975 (2:13 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">10.08.03 (1975) effective September 17, 1975 (2:21 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">10.08.08 (1977) effective March 24, 1978 (5:6 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">10.08.11 (1978) effective April 20, 1979 (6:8 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">10.08.13 (1980) effective as an emergency provision August 11, 1980 (7:20 Md. R. 1872); effective permanently December 12, 1980 (7:25 Md. R. 2336)</annotation> </annotations> </chapter> <chapter num="02" heading="Construction Funds for Public and Nonprofit Community Mental Health, Addiction, and Developmental Disabilities Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations govern the administration of State grant funds for public and nonprofit community mental health, addiction, and developmental disabilities facilities made available by the:</text> <paragraph num="(1)"> <text>Community Mental Health, Addiction, and Developmental Disabilities Facilities Loan Act of 1989, Chapter 126, Laws of Maryland 1989, and similar Acts;</text> </paragraph> <paragraph num="(2)"> <text>Maryland Consolidated Capital Bond Loan Act of 1990, Chapter 421, Laws of Maryland 1990, and similar Acts;</text> </paragraph> <paragraph num="(3)"> <text>Maryland Consolidated Capital Bond Loan Act of 1991, Chapter 471, Laws of Maryland 1991 and similar Acts; and</text> </paragraph> <paragraph num="(4)"> <text>Maryland Consolidated Capital Bond Loan Act of 1992, Chapter 4 (special session), Laws of Maryland 1992, and similar Acts.</text> </paragraph> </paragraph> <paragraph num="B."> <text>These regulations do not supersede, terminate, or abrogate the residual requirements of prior regulations adopted in accordance with the previous Acts which provided funds for these same purposes. The terms of the prior regulations, to the extent they conflict with these regulations, shall continue to govern the administration of funds for public and nonprofit facilities which receive, or have received, State grant funds authorized by Acts of years before 1992.</text> </paragraph> <paragraph num="C."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist eligible applicants for the construction, acquisition, renovation, and equipping of facilities eligible under the Act in accordance with these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Repealed." /> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as a community mental health, addiction, or developmental disabilities facility.</text> </paragraph> <paragraph num="(2)"> <text>“Act” means Health-General Article, §24-601 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Addiction” means a disease which is characterized by a pattern of pathological use of alcohol or a drug, or both, with repeated attempts to control the use and with significant negative consequences in at least one of the following areas of life:</text> <paragraph num="(a)"> <text>Financial;</text> </paragraph> <paragraph num="(b)"> <text>Legal;</text> </paragraph> <paragraph num="(c)"> <text>Medical; or</text> </paragraph> <paragraph num="(d)"> <text>Psychosocial.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Addiction facility” means any facility which provides or proposes to provide treatment for an addiction.</text> </paragraph> <paragraph num="(5)"> <text>“Applicant” means a county, a municipal corporation, or a nonprofit organization that seeks to obtain State grant funds under the Act.</text> </paragraph> <paragraph num="(6)"> <text>“Appropriate administration” means the Behavioral Health, Developmental Disabilities, or Prevention and Health Promotion Administration.</text> </paragraph> <paragraph num="(7)"> <text>“Community mental health facility” means a facility where one or more of the following mental health programs is provided, or is proposed to be provided:</text> <paragraph num="(a)"> <text>Inpatient services;</text> </paragraph> <paragraph num="(b)"> <text>Outpatient services;</text> </paragraph> <paragraph num="(c)"> <text>Partial care services, including day care services and night care services;</text> </paragraph> <paragraph num="(d)"> <text>24-hour emergency services;</text> </paragraph> <paragraph num="(e)"> <text>Aftercare services;</text> </paragraph> <paragraph num="(f)"> <text>Consultation services;</text> </paragraph> <paragraph num="(g)"> <text>Education services;</text> </paragraph> <paragraph num="(h)"> <text>Community rehabilitation services.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Construction.</text> <paragraph num="(a)"> <text>“Construction” means construction of new buildings or additions to existing buildings and initial capital equipment, including plans, specifications, site improvements, surveys, and applicable engineers' and architects' fees.</text> </paragraph> <paragraph num="(b)"> <text>“Construction” does not include the cost of land acquisition and the cost of off-site improvements.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>Developmental Disabilities Facility.</text> <paragraph num="(a)"> <text>“Developmental disabilities facility” means any facility which provides or proposes to provide services for individuals with disabilities, whether the facility is hospital-based, a clinic, vocational, day, or a residential site.</text> </paragraph> <paragraph num="(b)"> <text>For purposes of this definition, facility does not include a Veterans' Administration hospital.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Facility” means a:</text> <paragraph num="(a)"> <text>Public community mental health facility, addiction facility, or developmental disabilities facility that is wholly owned by, and operated under, the authority of a county or municipal corporation; or</text> </paragraph> <paragraph num="(b)"> <text>Nonprofit community mental health facility, addiction facility, or developmental disabilities facility that is wholly owned by, and operated under, the authority of a nonprofit organization or corporation.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Grantee” means a county, a municipal corporation, or a nonprofit organization or corporation for which State grant funds under the Act are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(13)"> <text>Initial Capital Equipment.</text> <paragraph num="(a)"> <text>“Initial capital equipment” means items which:</text> <paragraph num="(i)"> <text>Are necessary to furnish and initially operate a facility;</text> </paragraph> <paragraph num="(ii)"> <text>With normal maintenance have a life expectancy of at least 15 years; and</text> </paragraph> <paragraph num="(iii)"> <text>Are of durable construction.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Initial capital equipment” does not mean items which:</text> <paragraph num="(i)"> <text>Could be easily lost, damaged, or destroyed during normal usage;</text> </paragraph> <paragraph num="(ii)"> <text>Could be easily stolen;</text> </paragraph> <paragraph num="(iii)"> <text>Are likely to be technically obsolescent within 15 years; or</text> </paragraph> <paragraph num="(iv)"> <text>Are intended to replace a similar item already on hand.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Nonprofit facility” means a facility which is, or will be, wholly owned by and operated under the authority of a nonprofit organization.</text> </paragraph> <paragraph num="(15)"> <text>“Nonprofit organization” means:</text> <paragraph num="(a)"> <text>A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as a nonprofit organization; and</text> </paragraph> <paragraph num="(b)"> <text>That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(17)"> <text>“Public facility” means a facility that is wholly owned by and operated under the authority of a county or a municipal corporation.</text> </paragraph> <paragraph num="(18)"> <text>“Renovation” means the work required to restore or modernize, or both, most or all of a facility.</text> </paragraph> <paragraph num="(19)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(20)"> <text>Wholly Owned.</text> <paragraph num="(a)"> <text>“Wholly owned” includes leased property, if the lease agreement is with the State for a State-owned building or State-owned property.</text> </paragraph> <paragraph num="(b)"> <text>“Wholly owned” includes leased property which is not State-owned, if the:</text> <paragraph num="(i)"> <text>Lease agreement is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and</text> </paragraph> <paragraph num="(ii)"> <text>Lessor consents to the recording of a notice of the State's right of recovery, under Health-General Article, §24-606, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility of Applicant for State Grant Funds."> <paragraph num="A."> <text>To be eligible for State grant funds under the Act, an applicant shall:</text> <paragraph num="(1)"> <text>Be a county, a municipal corporation, or a nonprofit organization;</text> </paragraph> <paragraph num="(2)"> <text>Be recommended by the appropriate administration as a result of a proposal for a project conforming to the plans or program for services by that administration;</text> </paragraph> <paragraph num="(3)"> <text>Have proposed a project which is in accord with the priorities of the Secretary;</text> </paragraph> <paragraph num="(4)"> <text>Be eligible for licensing or certification under existing federal or State regulations, or both, when licensing or certification is required in order to provide treatment or services in the facility;</text> </paragraph> <paragraph num="(5)"> <text>Be eligible for certification, and agree to participate, in Title XVIII and Title XIX of the Social Security Act, if applicable;</text> </paragraph> <paragraph num="(6)"> <text>Have proposed a project which meets the handicap-accessibility requirements of COMAR 05.02.02, promulgated pursuant to Article 83B, §6-102, Annotated Code of Maryland, if applicable, and 42 U.S.C. §12101 et seq.; and</text> </paragraph> <paragraph num="(7)"> <text>Be approved by the Secretary to receive a grant award.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall apply for a grant to be used for construction, acquisition, renovation, and equipping of a facility by filing an application with the Department on a form provided by the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant shall direct an application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> <paragraph num="C."> <text>The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04.</text> </paragraph> <paragraph num="D."> <text>The applicant shall comply with the application procedures in effect at the time of application, as prescribed by applicable federal and State regulations.</text> </paragraph> <paragraph num="E."> <text>At the time of filing the application, and before the authorization of an award of State grant funds, the applicant shall file a written statement with the Department containing the following materials:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>The facility's admission policies, including:</text> <paragraph num="(a)"> <text>Statements in which the applicant shall:</text> <paragraph num="(i)"> <text>Agree to admit individuals on the basis of their need for services without regard to race, national origin, color, disability, religion, or ability to pay,</text> </paragraph> <paragraph num="(ii)"> <text>According to law and these regulations, define clearly proposed limitations, if any, regarding age groups, illness, or disorder categories, and</text> </paragraph> <paragraph num="(iii)"> <text>Give priority to individuals for admission to the facility who are certified by a local department of social services for assistance, and to individuals of low income;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For an applicant serving or intending to serve individuals in a developmental disabilities facility, an agreement to:</text> <paragraph num="(i)"> <text>Serve only those clients for whom the Developmental Disabilities Administration has authorized services in accordance with COMAR 10.22.18 or Health-General Article, §7-403, Annotated Code of Maryland, or</text> </paragraph> <paragraph num="(ii)"> <text>Obtain written permission from the Director, Developmental Disabilities Administration, before serving individuals not funded by the Developmental Disabilities Administration;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and other funds paid, or to be paid, to these personnel;</text> </paragraph> <paragraph num="(4)"> <text>Expenses incurred, or to be incurred, in carrying out qualified facilities operations;</text> </paragraph> <paragraph num="(5)"> <text>The schedule of rates charged, or to be charged, for services rendered;</text> </paragraph> <paragraph num="(6)"> <text>If a facility is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most current year; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant is applying for poverty funding under Regulation .07E of this chapter, an agreement that the majority of the individuals served by the applicant shall be poverty-designated clients, as defined in Regulation .07E of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the application meets all pertinent criteria, the Secretary, in the Secretary's discretion, may approve that application and, if approved, shall recommend the application to the Board of Public Works, together with a written report stating that:</text> <paragraph num="(1)"> <text>Notice and information in the application have been provided to the State Clearinghouse;</text> </paragraph> <paragraph num="(2)"> <text>The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority; and</text> </paragraph> <paragraph num="(3)"> <text>The Secretary recommends that the Board of Public Works make available to the applicant State grant funds.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Priority of Awards."> <text>The Department shall determine the priority of applicants for State grant funds after consideration of:</text> <paragraph num="A."> <text>All eligible applications;</text> </paragraph> <paragraph num="B."> <text>Each project, by the appropriate administration, for conformance with the program or plans for these services established by the respective administrations;</text> </paragraph> <paragraph num="C."> <text>Priorities as established by the Department;</text> </paragraph> <paragraph num="D."> <text>The reasonableness of the projected capital, and operating costs and revenues, for the facility;</text> </paragraph> <paragraph num="E."> <text>The availability of State grant funds;</text> </paragraph> <paragraph num="F."> <text>The total unallocated State grant funds available at the time the application is received; and</text> </paragraph> <paragraph num="G."> <text>The readiness of the project to go before the Board of Public Works.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>The provisions of these regulations apply to applicants for grants under the Act.</text> </paragraph> <paragraph num="B."> <text>Use of Federal Grants. Federal grant funds available for a project shall be applied first to the cost of construction, acquisition, renovation, and initial capital equipment of the facility, before a State grant is expended.</text> </paragraph> <paragraph num="C."> <text>Community Development Block Grants. Community development block grants are considered as local matching funds and are not considered as federal grant funds.</text> </paragraph> <paragraph num="D."> <text>Limits on State Grant.</text> <paragraph num="(1)"> <text>For a project without federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of eligible costs, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of eligible costs, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a project with federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of the eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may not be eligible for retroactive participation in the:</text> <paragraph num="(a)"> <text>Cost of:</text> <paragraph num="(i)"> <text>Acquisition;</text> </paragraph> <paragraph num="(ii)"> <text>Construction; and</text> </paragraph> <paragraph num="(iii)"> <text>Renovation; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Purchase of equipment.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Poverty Funding. An applicant is eligible for poverty funding for a facility, if the majority of individuals served by the facility:</text> <paragraph num="(1)"> <text>Are certified by a local department of social services as eligible for Family Investment Program (FIP) or Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(3)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Application Costs.</text> <paragraph num="(1)"> <text>An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings.</text> </paragraph> <paragraph num="(2)"> <text>If the project is recommended for funding by the Department, the Department shall review the costs expended under §F(1) of this regulation, and may recommend those costs to the Board of Public Works for inclusion in the grant award.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Matching Funds.</text> <paragraph num="(1)"> <text>The applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise.</text> </paragraph> <paragraph num="(3)"> <text>The Department may not consider real or personal property, in-kind contributions, or funds expended before the date a grant award is approved by the Board of Public Works, as matching funds.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Prohibition Against Use of Funds for Religious Purposes.</text> <paragraph num="(1)"> <text>A grantee may not use any portion of the proceeds of a State grant:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction; or</text> </paragraph> <paragraph num="(b)"> <text>In connection with the design, acquisition, or construction of any building used, or to be used, as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Use of Funds for Site Acquisition and Renovation."> <paragraph num="A."> <text>If the applicant is using both State funds and federal grant funds for site acquisition and renovation, then at least two State-approved appraisers shall determine that portion of the total cost applicable to the land site alone. The Department shall exclude this cost from State participation.</text> </paragraph> <paragraph num="B."> <text>If the applicant is acquiring a site with existing improvements and renovating the improvements for use as a community mental health, addiction, or developmental disabilities facility, and if the applicant will not be using a federal grant, then the total project costs, including costs applicable to the acquisition of this site and existing improvements, are eligible for State participation.</text> </paragraph> <paragraph num="C."> <text>In the circumstances outlined in §B of this regulation, at least two State-approved appraisers shall make an estimate of the market value of the site and existing improvements. State participation shall be limited to the lesser of the value approved by the Department of General Services based upon the appraisals or actual acquisition cost.</text> </paragraph> <paragraph num="D."> <text>If an applicant proposes to acquire a land site on which to construct a facility, the cost of the land is not eligible for State participation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For a period of 30 years following the completion of construction or renovation, or the acquisition of a facility involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material:</text> <paragraph num="(a)"> <text>The number of personnel employed at the facility, by occupation, and all remunerations, retainers, perquisites, and expenses currently paid;</text> </paragraph> <paragraph num="(b)"> <text>Fees or retainers paid directly or under contract to consultants and other persons rendering services at the facility;</text> </paragraph> <paragraph num="(c)"> <text>A current, certified, audited profit-and-loss statement and balance sheet for the facility;</text> </paragraph> <paragraph num="(d)"> <text>Rates and fees charged for services provided at the facility;</text> </paragraph> <paragraph num="(e)"> <text>Gifts or endowments received during the current year;</text> </paragraph> <paragraph num="(f)"> <text>Volume of service at the facility, such as the days of service rendered to inpatient clients, the number of day program clients and the number of days of service, or the number of outpatient clients and outpatient visits; and</text> </paragraph> <paragraph num="(g)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a period of 30 years following the completion of a project that receives poverty funding under Regulation .07E of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients, as set forth in Regulation .07E of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>The grantee shall provide builders’ risk insurance during the entire period of project construction or renovation as follows:</text> <paragraph num="(a)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall be endorsed to protect the State's interest in the building;</text> </paragraph> <paragraph num="(c)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On acquisition of a building or part of a building, the grantee shall provide all-risk insurance coverage as follows:</text> <paragraph num="(a)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>The policy shall be endorsed to protect the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Notification of cancellation of the policy,</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy, and</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The grantee shall:</text> <paragraph num="(i)"> <text>Maintain this insurance for a period of 30 years, and</text> </paragraph> <paragraph num="(ii)"> <text>Submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of a project, the grantee shall maintain, for a period of 30 years, all-risk insurance coverage as follows:</text> <paragraph num="(a)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>The policy shall be endorsed to protect the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Notification of cancellation of the policy,</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy, and</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the grantee shall make available the business records of the facility for verification by representatives of the Department or its designated agent.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion, and Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation by the Maryland legislature.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time, for good cause.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) and (2)(a)—(d) of this regulation, and a notice of the right of recovery is recorded in the land records of the county or Baltimore City in which the property is located.</text> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with §§A, B(2) and (3), and C of this regulation, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under the Act; and</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Right of Recovery."> <text>In the event of default under the terms of the Act and this chapter, a facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-102, 24-601, et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 23, 1987 (14:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .03—.10 amended and Regulation .02 repealed effective December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective March 9, 1998 (25:5 Md. R. 369)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Annotation: The following chapters were originally adopted to govern the administration of construction funds for public and nonprofit community mental health center components, addiction facilities, and developmental disabilities facilities. These chapters were repealed effective February 23, 1987 (14:4 Md. R. 417) and replaced by the current COMAR 10.08.02:</annotation> <annotation type="History" subtype="Administrative History">10.08.04 (1972) effective April 26, 1973; amended effective July 7, 1976 (3:14 Md. R. 746)</annotation> <annotation type="History" subtype="Administrative History">10.08.05 (1973) effective April 30, 1975 (2:9 Md. R. 677); amended effective July 7, 1976 (3:14 Md. R. 746)</annotation> <annotation type="History" subtype="Administrative History">10.08.06 (1974) effective September 17, 1975 (2:21 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">10.08.07 (1975) effective July 7, 1976 (3:14 Md. R. 747)</annotation> <annotation type="History" subtype="Administrative History">10.08.09 (1977) effective March 24, 1978 (5:6 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">10.08.10 (1978) effective May 4, 1979 (6:9 Md. R. 727)</annotation> <annotation type="History" subtype="Administrative History">10.08.12 (1979) effective February 22, 1980 (7:4 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">10.08.14 (1980) effective April 17, 1981 (8:8 Md. R. 720)</annotation> <annotation type="History" subtype="Administrative History">10.08.15 (1981) effective as an emergency provision July 15, 1981 (8:15 Md. R. 1296); effective permanently November 23, 1981 (8:23 Md. R. 1855)</annotation> <annotation type="History" subtype="Administrative History">10.08.16 (1982) effective January 17, 1983 (10:1 Md. R. 29)</annotation> <annotation type="History" subtype="Administrative History">10.08.17 (1983) effective as an emergency provision August 24, 1983 (10:19 Md. R. 1684); effective permanently March 12, 1984 (11:5 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">10.08.18 (1984) effective as an emergency provision August 15, 1984 (11:18 Md. R. 1578); effective permanently December 31, 1984 (11: 26 Md. R. 2278)</annotation> </annotations> </chapter> <chapter num="03" heading="Construction Funds for Public and Nonprofit Adult Day Care Centers"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations govern the administration of State grant funds to counties, municipal corporations, and nonprofit organizations for conversion, acquisition, renovation, equipping, and construction of adult day care centers under the Adult Day Care Centers Loan Act of 1987, Health-General Article, §§24-701—24-707, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>These regulations do not supersede, terminate, or abrogate the residual requirements of prior regulations adopted in accordance with the previous Acts which provided funds for these same purposes. The terms of the prior regulations, to the extent they conflict with these regulations, shall continue to govern the administration of funds for public and nonprofit facilities which receive, or have received, State grant funds authorized by Acts of years before 1991.</text> </paragraph> <paragraph num="C."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of adult day care center facilities, eligible under the Act in accordance with these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as an adult day care center.</text> </paragraph> <paragraph num="(2)"> <text>“Act” means Health-General Article, §§24-701—24-707, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of an adult day care center.</text> </paragraph> <paragraph num="(3)"> <text>“Adult day care center” means a nonresidential center that:</text> <paragraph num="(a)"> <text>Serves the elderly, medically handicapped adults, or victims of Alzheimer's disease and related disorders;</text> </paragraph> <paragraph num="(b)"> <text>Meets the definitions in Health-General Article, §14-201(b) or §14-301(b), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Is licensed by the Department under COMAR 10.12.04.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Applicant” means a county, municipal corporation, or nonprofit organization that seeks to obtain State grant funds under the Act.</text> </paragraph> <paragraph num="(5)"> <text>“Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Building” means:</text> <paragraph num="(a)"> <text>All or part of an existing or potential adult day care center and its surrounding real property; or</text> </paragraph> <paragraph num="(b)"> <text>A facility proposed to be constructed for use as an adult day care center, and its surrounding real property.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>“Construction” means constructing new buildings or additions to existing buildings and initial capital equipment, including architects' fees.</text> </paragraph> <paragraph num="(b)"> <text>“Construction” does not include the cost of land acquisition and the cost of off-site improvements.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Conversion” means the work required to transform a building or part of a building for effective use as an adult day care center.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Eligible work” means that work for which the use of State funds is authorized under Health-General Article, §§24-701—24-707, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Facility” means an adult day care center that is wholly owned by and operated under the authority of a:</text> <paragraph num="(a)"> <text>County or municipal corporation; or</text> </paragraph> <paragraph num="(b)"> <text>Nonprofit organization.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Grant” means a State grant provided under the adult day care center loan program, unless the context clearly implies otherwise.</text> </paragraph> <paragraph num="(13)"> <text>“Grantee” means a county, municipal corporation, or nonprofit organization for which State grant funds under the Act are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(14)"> <text>Initial Capital Equipment.</text> <paragraph num="(a)"> <text>“Initial capital equipment” means items which:</text> <paragraph num="(i)"> <text>Are necessary to furnish and initially operate a facility;</text> </paragraph> <paragraph num="(ii)"> <text>With normal maintenance, have a life expectancy of at least 15 years; and</text> </paragraph> <paragraph num="(iii)"> <text>Are of durable construction.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Initial capital equipment” does not include items which:</text> <paragraph num="(i)"> <text>Could be easily lost, damaged, or destroyed during normal usage;</text> </paragraph> <paragraph num="(ii)"> <text>Could be easily stolen;</text> </paragraph> <paragraph num="(iii)"> <text>Are likely to be technically obsolescent within 15 years; or</text> </paragraph> <paragraph num="(iv)"> <text>Are intended to replace a similar item already on hand.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Nonprofit adult day care center” means an adult day care center which is, or will be, wholly owned by and operated under the authority of a nonprofit organization.</text> </paragraph> <paragraph num="(16)"> <text>“Nonprofit organization” means:</text> <paragraph num="(a)"> <text>A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as nonprofit; and</text> </paragraph> <paragraph num="(b)"> <text>That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(18)"> <text>“Operating costs” means costs associated with the operation of an adult day care center.</text> </paragraph> <paragraph num="(19)"> <text>“Project” means an existing or proposed adult day care center which receives or has received a State grant for eligible work.</text> </paragraph> <paragraph num="(20)"> <text>“Public facility” means a facility that is wholly owned by and operated under the authority of a county or municipal corporation.</text> </paragraph> <paragraph num="(21)"> <text>“Renovation” means the work required to restore or modernize, or both, an existing or proposed adult day care center.</text> </paragraph> <paragraph num="(22)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(23)"> <text>“Wholly owned” includes leased property, if the lease agreement:</text> <paragraph num="(a)"> <text>Is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and</text> </paragraph> <paragraph num="(b)"> <text>Consents to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-706, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Eligibility of Applicant for State Grant Funds."> <paragraph num="A."> <text>To be eligible for State grant funds under the Act, an applicant shall:</text> <paragraph num="(1)"> <text>Be a county, municipal corporation, or a nonprofit organization;</text> </paragraph> <paragraph num="(2)"> <text>Be eligible for licensing under COMAR 10.12.04;</text> </paragraph> <paragraph num="(3)"> <text>Have relevant experience providing related health or human services;</text> </paragraph> <paragraph num="(4)"> <text>Be recommended by the Medical Care Policy Administration as a project conforming to the Administration's 5-year plan for these services;</text> </paragraph> <paragraph num="(5)"> <text>Complete a feasibility study as specified and approved by the Medical Care Policy Administration;</text> </paragraph> <paragraph num="(6)"> <text>Certify that the proposed facility will meet the handicap-accessibility requirements of COMAR 10.12.04 and 42 U.S.C. §12101 et seq.;</text> </paragraph> <paragraph num="(7)"> <text>Be eligible for certification, and agree to participate in Title XVIII and Title XIX of the Social Security Act, if applicable; and</text> </paragraph> <paragraph num="(8)"> <text>Be approved by the Secretary to receive a grant award.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall apply for a grant to be used for conversion, acquisition, renovation, purchase of capital equipment, and construction by filing an application with the Department on a form provided by the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant shall direct the application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> <paragraph num="C."> <text>The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04.</text> </paragraph> <paragraph num="D."> <text>The applicant shall comply with the application procedures in effect at the time of application, as prescribed by applicable federal and State regulations, including COMAR 10.12.04.</text> </paragraph> <paragraph num="E."> <text>At the time of filing the application, and before the authorization of an award of State grant funds, the applicant shall file a written statement with the Department containing the following material:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any other funds paid, or to be paid, to these personnel;</text> </paragraph> <paragraph num="(3)"> <text>Expenses incurred or to be incurred in carrying out qualified facility operations;</text> </paragraph> <paragraph num="(4)"> <text>Schedule of rates charged or to be charged for services rendered at the facility;</text> </paragraph> <paragraph num="(5)"> <text>Agreement to admit persons on the basis of their need for services without regard to race, national origin, color, disability, or religion, and to define clearly proposed limitations, if any, regarding age groups, level of functional impairment, or disability;</text> </paragraph> <paragraph num="(6)"> <text>If a facility is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most current year; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant is applying for poverty funding under Regulation .06F of this chapter, an agreement that the majority of the persons served by the applicant shall be poverty-designated clients, as defined in Regulation .06F of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the application meets all pertinent criteria, the Secretary may approve that application and may recommend the application to the Board of Public Works, together with a written report stating that:</text> <paragraph num="(1)"> <text>Notice and information in the application have been provided to the State Clearinghouse;</text> </paragraph> <paragraph num="(2)"> <text>The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority under provisions of federal regulations; and</text> </paragraph> <paragraph num="(3)"> <text>The Secretary recommends that the Board of Public Works make available to the applicant State grant funds.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Priority of Awards."> <text>The Department shall determine the priority of applicants to be awarded State grant funds after consideration of:</text> <paragraph num="A."> <text>All eligible applications;</text> </paragraph> <paragraph num="B."> <text>The 5-year plan of the Medical Assistance Policy Administration for these services;</text> </paragraph> <paragraph num="C."> <text>Priorities as established by the Department;</text> </paragraph> <paragraph num="D."> <text>The reasonableness of the projected capital, and operating costs and revenues, for the facility;</text> </paragraph> <paragraph num="E."> <text>The availability of State grant funds;</text> </paragraph> <paragraph num="F."> <text>The total of unallocated State grant funds available at the time the application is received; and</text> </paragraph> <paragraph num="G."> <text>The readiness of the project to go before the Board of Public Works.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>The provisions of these regulations apply to applicants for grants under the Act.</text> </paragraph> <paragraph num="B."> <text>Alternative Public Building. State funds may be used to acquire an existing building or part of a building for use as an adult day care center, or to plan, design, and construct an adult day care center, only if the local government and the Department certify to the Board of Public Works that a surplus school building or other public building appropriate for use as an adult day care center does not exist in the area where it is desired to locate a center.</text> </paragraph> <paragraph num="C."> <text>Use of Federal Grants. Any federal grants available for a project shall be applied first to the cost of the project, before a State grant is expended.</text> </paragraph> <paragraph num="D."> <text>Community Development Block Grants. Community development block grants are considered as local matching funds and are not considered as federal grant funds.</text> </paragraph> <paragraph num="E."> <text>Limits on State Grant.</text> <paragraph num="(1)"> <text>For a project without federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of eligible costs, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of eligible costs, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a project with federal participation, a State grant may not be more than:</text> <paragraph num="(a)"> <text>50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or</text> </paragraph> <paragraph num="(b)"> <text>75 percent of eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant is not eligible for retroactive participation in the cost of acquisition, construction, renovation, or purchase of equipment.</text> </paragraph> <paragraph num="(4)"> <text>The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Poverty Fundings. An applicant is eligible for poverty funding for a facility if the majority of individuals served by the facility:</text> <paragraph num="(1)"> <text>Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(3)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Application Costs.</text> <paragraph num="(1)"> <text>An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings.</text> </paragraph> <paragraph num="(2)"> <text>If the project is recommended for funding by the Department, the Department shall review the costs expended under §G(1) of this regulation and may recommend those costs to the Board of Public Works for inclusion in the grant award.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Matching Funds.</text> <paragraph num="(1)"> <text>The applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise.</text> </paragraph> <paragraph num="(3)"> <text>The Department may not consider real or personal property, in-kind contributions, or, unless approved by the Board of Public Works under §H(2) of this regulation, funds expended before the date a grant award is approved by the Board of Public Works as matching funds.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Prohibition Against Use of Funds for Religious Purposes.</text> <paragraph num="(1)"> <text>A grantee may not use any portion of the proceeds of a State grant:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction; or</text> </paragraph> <paragraph num="(b)"> <text>In connection with the design, acquisition, or construction of any building used, or to be used, as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Use of Funds for Site Acquisition and Renovation."> <paragraph num="A."> <text>If the applicant is using both State funds and federal grant funds for site acquisition and renovation, then at least two State-approved appraisers shall determine that portion of the total cost applicable to the land site alone. The Department shall exclude this cost from State participation.</text> </paragraph> <paragraph num="B."> <text>If the applicant is acquiring a site with existing improvements and renovating the improvements for use as an adult day care center, and if the applicant will not be using a federal grant, then the total project costs, including costs applicable to the acquisition of this site and existing improvements, are eligible for State participation.</text> </paragraph> <paragraph num="C."> <text>In the circumstances outlined in §B of this regulation, at least two State-approved appraisers shall make an estimate of the market value of the site and existing improvements. State participation is limited to the lesser of the value approved by the Department of General Services based upon the appraisals or actual acquisition cost.</text> </paragraph> <paragraph num="D."> <text>If an applicant proposes to acquire a land site on which to construct a facility, the cost of the land is not eligible for State participation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For a period of 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of an adult day care center involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department, containing the following material:</text> <paragraph num="(a)"> <text>The number of personnel employed at the facility, by occupation, and all remunerations, retainers, perquisites, and expenses currently paid;</text> </paragraph> <paragraph num="(b)"> <text>Fees or retainers paid directly or under contract to consultants and other persons rendering services at the facility;</text> </paragraph> <paragraph num="(c)"> <text>A current, certified, audited profit-and-loss statement and balance sheet for the facility;</text> </paragraph> <paragraph num="(d)"> <text>Rates and fees charged for services provided at the facility;</text> </paragraph> <paragraph num="(e)"> <text>Gifts or endowments received during the current year;</text> </paragraph> <paragraph num="(f)"> <text>Volume of service at the adult day care center, such as days of service rendered to clients; and</text> </paragraph> <paragraph num="(g)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a period of 30 years following the completion of a project that receives poverty funding under Regulation .06F of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients, as described in Regulation .06F of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>The grantee shall provide builders' risk insurance during the entire period of project construction or renovation as follows:</text> <paragraph num="(a)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall be endorsed to protect the State's interest in the building;</text> </paragraph> <paragraph num="(c)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon acquisition of a building or part of a building, the grantee shall provide all-risk insurance coverage as follows:</text> <paragraph num="(a)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>The policy shall be endorsed to protect the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Notification of cancellation of the policy,</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy, and</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The grantee shall:</text> <paragraph num="(i)"> <text>Maintain this insurance for a period of 30 years, and</text> </paragraph> <paragraph num="(ii)"> <text>Submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of a project, the grantee shall maintain, for a period of 30 years, all-risk insurance coverage as follows:</text> <paragraph num="(a)"> <text>The coverage shall be for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The policy shall name the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>The policy shall be endorsed to protect the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Notification of cancellation of the policy,</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy, and</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the grantee shall make available business records of the adult day care center for verification by representatives of the Department or its designated agent.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion, and Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation by the Maryland legislature.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time, for good cause.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) and (2)(a)—(d) of this regulation, and a notice of the right of recovery is recorded in the land records of the county or Baltimore City in which the property is located.</text> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with §§A, B(2) and (3), and C of this regulation, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under the Act; and</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Right of Recovery."> <text>In the event of default under the terms of the Act and this chapter, an adult day care center financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24-701 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 28, 1987 (14:26 Md. R. 2746)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective March 9, 1998 (25:5 Md. R. 369); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> </annotations> </chapter> <chapter num="04" heading="Construction Funds for Public and Nonprofit Assisted Living Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the administration of State grant funds to counties, municipal corporations, and nonprofit organizations for conversion, acquisition, renovation, equipping, and construction of assisted living facilities under the Assisted Living Facilities Grant Program, Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of assisted living facilities, eligible under the Act in accordance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as an assisted living facility.</text> </paragraph> <paragraph num="(2)"> <text>“Act” means Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of an assisted living facility.</text> </paragraph> <paragraph num="(3)"> <text>“Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any, regarding age or level of functional medical impairment, or both.</text> </paragraph> <paragraph num="(4)"> <text>“Assisted living facility” means a residential facility or facility-based program that:</text> <paragraph num="(a)"> <text>Meets the definitions in Health-General Article, §19-1801, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed by the Department under COMAR 10.07.14.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Applicant” means a county, municipal corporation, or nonprofit organization that seeks to obtain State grant funds under the Act.</text> </paragraph> <paragraph num="(6)"> <text>“Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Building” means:</text> <paragraph num="(a)"> <text>All or part of an existing assisted living facility and its surrounding real property;</text> </paragraph> <paragraph num="(b)"> <text>All or part of an existing facility to be converted to assisted living and its surrounding real property; or</text> </paragraph> <paragraph num="(c)"> <text>A facility proposed to be constructed for use as an assisted living facility, and its surrounding real property.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Construction.</text> <paragraph num="(a)"> <text>“Construction” means construction of new buildings or additions to existing buildings, including architects' fees and initial capital equipment.</text> </paragraph> <paragraph num="(b)"> <text>“Construction” does not include cost of:</text> <paragraph num="(i)"> <text>Demolition of improvements that return the land to unimproved condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Unimproved land acquisition and the cost of off-site infrastructure improvements, such as roads, water, and sewer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Conversion” means the work required to transform a building or part of a building for effective use as an assisted living facility.</text> </paragraph> <paragraph num="(10)"> <text>“Default” means:</text> <paragraph num="(a)"> <text>Transfer of property to a person, agency, or organization that would not qualify as an applicant, or that is not approved as a transferee by the Board of Public Works;</text> </paragraph> <paragraph num="(b)"> <text>Failure to complete a project and obtain an occupancy permit;</text> </paragraph> <paragraph num="(c)"> <text>Failure to commence operation of a facility within 1 year after obtaining an occupancy permit; or</text> </paragraph> <paragraph num="(d)"> <text>Failure to qualify as a facility, as defined in §B(14) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(12)"> <text>“Eligible person” means an individual who meets facility admission criteria.</text> </paragraph> <paragraph num="(13)"> <text>“Eligible work” means that work for which the use of State funds is authorized under the Act.</text> </paragraph> <paragraph num="(14)"> <text>“Facility” means an assisted living facility that is wholly owned by and operated under the authority of a:</text> <paragraph num="(a)"> <text>County or municipal corporation; or</text> </paragraph> <paragraph num="(b)"> <text>Nonprofit organization.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Grant” means any funds competitively awarded from any source to the applicant including a State grant.</text> </paragraph> <paragraph num="(16)"> <text>“Grantee” means a county, municipal corporation, or nonprofit organization for which State grant funds under the Act are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(17)"> <text>“Initial capital equipment” means items that:</text> <paragraph num="(a)"> <text>With normal maintenance, have a life expectancy of at least 15 years;</text> </paragraph> <paragraph num="(b)"> <text>Have durable construction; and</text> </paragraph> <paragraph num="(c)"> <text>Are necessary to furnish a new facility.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Nonprofit assisted living facility” means an assisted living facility which is wholly owned by and operated under the authority of a nonprofit organization.</text> </paragraph> <paragraph num="(19)"> <text>“Nonprofit organization” means a bona fide religious organization, or a chartered nonprofit corporation which:</text> <paragraph num="(a)"> <text>Is classified under §501(c)3 of the Internal Revenue Code as a nonprofit; and</text> </paragraph> <paragraph num="(b)"> <text>Has no earnings which inure to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Operating costs” means costs associated with the operation of an assisted living facility.</text> </paragraph> <paragraph num="(22)"> <text>“Project” means an existing or proposed assisted living facility which receives or has received a State grant for conversion, acquisition, renovation, equipping, or construction.</text> </paragraph> <paragraph num="(23)"> <text>“Public facility” means a facility that is wholly owned by and operated under the authority of a county or municipal corporation.</text> </paragraph> <paragraph num="(24)"> <text>“Renovation” means restoration or modernization, or both, to an existing or proposed assisted living facility.</text> </paragraph> <paragraph num="(25)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(26)"> <text>“State grant” means State funds awarded under the Assisted Living Facilities Grant Program, unless the context clearly implies otherwise.</text> </paragraph> <paragraph num="(27)"> <text>“Wholly owned” includes leased property, if the lease agreement:</text> <paragraph num="(a)"> <text>Is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and</text> </paragraph> <paragraph num="(b)"> <text>Includes a consent to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-1006, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of State Grant Funds."> <paragraph num="A."> <text>State grant funds for assisted living facilities may be used for the following:</text> <paragraph num="(1)"> <text>The conversion of public buildings or parts of buildings;</text> </paragraph> <paragraph num="(2)"> <text>The acquisition of existing buildings or parts of buildings;</text> </paragraph> <paragraph num="(3)"> <text>The renovation of assisted living facilities;</text> </paragraph> <paragraph num="(4)"> <text>The purchase of initial capital equipment; or</text> </paragraph> <paragraph num="(5)"> <text>The plan, design, and construction of an assisted living facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>State grant funds may be used to acquire an existing building or part of a building or to plan, design, and construct an assisted living facility only if the local government and the Department certify to the Board of Public Works that a surplus public building appropriate for use as an assisted living facility does not exist in the area in which the proposed assisted living facility is to be located.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligible Applicants for State Grant Funds."> <text>To be eligible to apply for State grant funds under the Act, an applicant shall:</text> <paragraph num="A."> <text>Be a county, municipal corporation, or a nonprofit organization;</text> </paragraph> <paragraph num="B."> <text>Sponsor a project involving work specified in Regulation .03A of this chapter;</text> </paragraph> <paragraph num="C."> <text>Have relevant experience providing related health or human services or provide evidence of intent to contract with a provider of assisted living services; and</text> </paragraph> <paragraph num="D."> <text>Certify that the proposed facility will meet the handicap-accessibility requirements of COMAR 10.07.14 and 42 U.S.C. §12101 et seq., or provide a certified waiver from the Department of Housing and Community Development.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall apply for a State grant by filing an application with the Department on a form provided by the Department, and shall direct the completed application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> <paragraph num="B."> <text>The Department shall provide any notice and information to the State Clearinghouse for intergovernmental review that may be required under COMAR 14.24.04.</text> </paragraph> <paragraph num="C."> <text>The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application, including COMAR 10.07.14.</text> </paragraph> <paragraph num="D."> <text>At the time of filing the application, the applicant shall file a written statement with the Department containing the following material:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel;</text> </paragraph> <paragraph num="(3)"> <text>Expenses incurred, or to be incurred, in carrying out qualified facility operations;</text> </paragraph> <paragraph num="(4)"> <text>Schedule of rates charged, or to be charged, for services rendered at the facility;</text> </paragraph> <paragraph num="(5)"> <text>Agreement to admit eligible persons on the basis of their need for services without regard to race, religion, national origin, color, or disability;</text> </paragraph> <paragraph num="(6)"> <text>If an applicant is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most recent year; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Secretary shall approve applications that meet the requirements of this regulation and the priorities of the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Amount of State Grant Awards."> <text>The Department shall determine the amount of the State grant for an applicant's project after consideration of the following:</text> <paragraph num="A."> <text>All eligible applications;</text> </paragraph> <paragraph num="B."> <text>Priorities of need as established by the Department;</text> </paragraph> <paragraph num="C."> <text>The total unallocated State funds available in the Department's Administration-Sponsored Capital Programs for Assisted Living at the time the application is received;</text> </paragraph> <paragraph num="D."> <text>The projected amount of anticipated appropriations as provided in the Governor's 5-Year Capital Improvement Program;</text> </paragraph> <paragraph num="E."> <text>The reasonableness of the total cost of the project; and</text> </paragraph> <paragraph num="F."> <text>Current operating costs or the reasonableness of a projected budget and revenues for the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recommendation of State Grant Awards."> <paragraph num="A."> <text>The Department shall determine whether the approved application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following:</text> <paragraph num="(1)"> <text>The availability of State grant funds;</text> </paragraph> <paragraph num="(2)"> <text>The receipt of satisfactory evidence from the applicant of the following requirements:</text> <paragraph num="(a)"> <text>Sufficient total financial contribution to complete the project;</text> </paragraph> <paragraph num="(b)"> <text>Control of site, such as deed or lease;</text> </paragraph> <paragraph num="(c)"> <text>Compliance with applicable local zoning requirements;</text> </paragraph> <paragraph num="(d)"> <text>Certification that the project site is located in a State-approved Smart Growth area;</text> </paragraph> <paragraph num="(e)"> <text>Certified bid tabulation, construction contract, contract of sale, or 30-year lease agreement with landlord, contingent on Board of Public Works approval; and</text> </paragraph> <paragraph num="(f)"> <text>Compliance with all other applicable provisions of State or federal law; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Whether the local government has certified to the Department that a surplus public building appropriate for use as an assisted living facility does not exist in the area in which the facility is to be located, if a new building is to be constructed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon satisfactory completion of §A(1) and (2) of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report:</text> <paragraph num="(1)"> <text>Stating that a notice, including information in the application, has been provided to the State Clearinghouse;</text> </paragraph> <paragraph num="(2)"> <text>Stating that the application has been approved by the Secretary;</text> </paragraph> <paragraph num="(3)"> <text>Stating the amount of a federal grant, if any is involved, that has been awarded to the applicant;</text> </paragraph> <paragraph num="(4)"> <text>If required, stating that the local government has certified that there is no surplus public building; and</text> </paragraph> <paragraph num="(5)"> <text>If required, certifying that there is no surplus public building.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>Use of Federal Grants and Other Grants.</text> <paragraph num="(1)"> <text>Any federal or other grant that is received for an eligible project shall be applied first to the cost of the project.</text> </paragraph> <paragraph num="(2)"> <text>All other sources of funds shall be expended before the State grant is expended on an approved project.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limits of State Grant.</text> <paragraph num="(1)"> <text>Except as provided in §D(1) and (2) of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied.</text> </paragraph> <paragraph num="(2)"> <text>A State grant may not be used for retroactive participation in the cost of conversion, construction, renovation, acquisition, or purchase of equipment.</text> </paragraph> <paragraph num="(3)"> <text>The State grant may include only those costs incurred or obligations contracted for after the application has been approved by the Department.</text> </paragraph> <paragraph num="(4)"> <text>Costs necessary and appropriate for filing an application, such as appraisals, surveys, and test borings, shall be paid by the applicant. These costs may be approved for funding by the Board of Public Works, if the project is approved by the Board of Public Works.</text> </paragraph> <paragraph num="(5)"> <text>State grant funds may not be used to pay certain costs. These costs include:</text> <paragraph num="(a)"> <text>Closing costs;</text> </paragraph> <paragraph num="(b)"> <text>Noncapital equipment;</text> </paragraph> <paragraph num="(c)"> <text>Consultant services;</text> </paragraph> <paragraph num="(d)"> <text>Land;</text> </paragraph> <paragraph num="(e)"> <text>Off-site improvements; and</text> </paragraph> <paragraph num="(f)"> <text>Amounts that exceed the appraised value of the real property.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Exceptions on State Grant Limits.</text> <paragraph num="(1)"> <text>The Department may request Board of Public Works approval for a State grant to exceed 50 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied, if:</text> <paragraph num="(a)"> <text>The project involves the conversion of a public building or part of a building to an assisted living facility, the renovation of an assisted living facility, or the planning, design, and construction of an assisted living facility;</text> </paragraph> <paragraph num="(b)"> <text>The value of real property and improvements made available by the local government, or the value of the center to be renovated, equals or exceeds the amount of the State grant;</text> </paragraph> <paragraph num="(c)"> <text>State funds have not been used for the acquisition, construction, or maintenance of any real property and improvements made available by the local government or any building to be converted or renovated; and</text> </paragraph> <paragraph num="(d)"> <text>The State is not responsible for any bonded indebtedness in connection with any real property and improvements made available by the local government or any building to be converted or renovated.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A project designated as eligible for poverty area under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if:</text> <paragraph num="(1)"> <text>The project complies with all applicable federal regulations and State plans or Departmental regulations; and</text> </paragraph> <paragraph num="(2)"> <text>The majority of individuals served by the facility:</text> <paragraph num="(a)"> <text>Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance;</text> </paragraph> <paragraph num="(b)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(c)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Funding Contribution Requirements</text> <paragraph num="(1)"> <text>The applicant shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may not expend the State grant award before other sources of funds are expended unless the Board of Public Works approves otherwise.</text> </paragraph> <paragraph num="(4)"> <text>The Department may not consider as contributions:</text> <paragraph num="(a)"> <text>Real or personal property;</text> </paragraph> <paragraph num="(b)"> <text>In-kind contributions; or</text> </paragraph> <paragraph num="(c)"> <text>Unless approved by the Board of Public Works under §B(4) of this regulation, funds expended before the date a grant award is approved by the Board of Public Works.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Prohibition Against Use of the Project for Purposes Other Than Assisted Living.</text> <paragraph num="(1)"> <text>A grantee may not use a project funded by a State grant primarily:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction or services;</text> </paragraph> <paragraph num="(b)"> <text>As a place of sectarian religious worship or instruction, or primarily in connection with any program or department of divinity for any religious denomination; or</text> </paragraph> <paragraph num="(c)"> <text>For any purpose other than assisted living.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Use of Funds for Acquisition and Renovation."> <paragraph num="A."> <text>If the applicant is acquiring a site with existing improvements, and the existing improvements are to be renovated for or used for an assisted living facility, the total project costs may be eligible for State participation.</text> </paragraph> <paragraph num="B."> <text>In the circumstances outlined in §A of this regulation, at least two State-approved appraisers shall provide appraisals of the site and existing improvements to be acquired. State participation shall be limited to the lesser of the appraised value approved by the Department of General Services based upon the appraisals or the actual acquisition cost.</text> </paragraph> <paragraph num="C."> <text>If an applicant proposes to acquire an unimproved land site on which to construct a facility, the cost of the land is not eligible for State participation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For a period of 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of an assisted living facility involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material:</text> <paragraph num="(a)"> <text>A recent certified, audited profit-and-loss statement and balance sheet for the facility;</text> </paragraph> <paragraph num="(b)"> <text>Volume of service at the assisted living facility, such as days of service rendered to clients; and</text> </paragraph> <paragraph num="(c)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a period of 30 years following the completion of a project that receives poverty funding under Regulation .07D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project; and</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The grantee shall provide builders' risk insurance coverage during the entire period of project construction or renovation that:</text> <paragraph num="(a)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>Protects the State's interest in the building;</text> </paragraph> <paragraph num="(c)"> <text>Provides an amount at least equal to the replacement cost of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of a project, the grantee shall maintain, for a period of 30 years, an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> <paragraph num="C."> <text>During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, or assigns.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion, and Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall promptly notify the Secretary, if the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation by the Maryland legislature.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For good cause the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time.</text> </paragraph> <paragraph num="(3)"> <text>Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of an additional 180 days to encumber funds.</text> </paragraph> <paragraph num="(4)"> <text>Absent good cause, the applicant shall be ineligible for grant funds. The applicant may apply for funds in future years.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be released until the applicant has a notice of the right of recovery recorded in the land records of the county or Baltimore City in which the property is located, and the applicant is in compliance with this chapter and applicable federal and State laws.</text> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under the Act;</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Office of Health Care Quality; and</text> </paragraph> <paragraph num="(4)"> <text>Take other action as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Right of Recovery."> <text>In the event of default under the terms of the Act and this chapter, an assisted living facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 10, 2001 (28:24 Md. R. 2128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective March 9, 1998 (25:5 Md. R. 369); March 26, 2018 (45:6 Md. R. 319)</annotation> </annotations> </chapter> <chapter num="05" heading="Construction Funds for Federally Qualified Health Centers"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the administration of State grant funds to counties, municipal corporations, nonprofit corporations and other entities, hereinafter “entities”, that are authorized for funding under §330 of the Public Health Service Act (42 U.S.C. 254b) administered by the United States Department of Health and Human Services, Health Resources and Services Administration, Bureau of Primary Health Care. These grants are for the conversion, acquisition, renovation, equipping, and construction of federally qualified health centers under the Federally Qualified Health Centers Grant Program, Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of federally qualified health centers, eligible under the Act in accordance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as a federally qualified health center.</text> </paragraph> <paragraph num="(2)"> <text>“Act” means Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of a federally qualified health center.</text> </paragraph> <paragraph num="(3)"> <text>“Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means a qualified entity that has submitted an application.</text> </paragraph> <paragraph num="(5)"> <text>“Application” means the forms required and published by the Department, and submitted by the applicant to the Office of Capital Planning, Budgeting, and Engineering Services, to apply for a State grant for a project.</text> </paragraph> <paragraph num="(6)"> <text>“Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Building” means:</text> <paragraph num="(a)"> <text>All or part of an existing federally qualified health center;</text> </paragraph> <paragraph num="(b)"> <text>All or part of an existing facility to be converted to a federally qualified health center; or</text> </paragraph> <paragraph num="(c)"> <text>A facility proposed to be constructed on a designated site for use as a federally qualified health center.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Capital equipment” means items that:</text> <paragraph num="(a)"> <text>With normal maintenance, have a life expectancy of at least 15 years; and</text> </paragraph> <paragraph num="(b)"> <text>Have durable construction.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Construction.</text> <paragraph num="(a)"> <text>“Construction” means construction of new buildings or additions to existing buildings, including architects' fees and capital equipment.</text> </paragraph> <paragraph num="(b)"> <text>“Construction” does not include cost of:</text> <paragraph num="(i)"> <text>The demolition of improvements that return the land to unimproved condition;</text> </paragraph> <paragraph num="(ii)"> <text>The acquisition of unimproved land, and</text> </paragraph> <paragraph num="(iii)"> <text>The construction of off-site infrastructure improvements, such as roads, water, and sewer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Conversion” means the work required to transform a building or part of a building for effective use as a federally qualified health center.</text> </paragraph> <paragraph num="(11)"> <text>“Default” means:</text> <paragraph num="(a)"> <text>Transfer of property that has ceased to be a federally qualified health center to any person, agency, or organization that would not qualify as an applicant, or that is not approved as a transferee by the Board of Public Works;</text> </paragraph> <paragraph num="(b)"> <text>Failure to complete a project and to obtain a required occupancy permit;</text> </paragraph> <paragraph num="(c)"> <text>Failure to commence operation of a facility within 1 year after obtaining an occupancy permit; or</text> </paragraph> <paragraph num="(d)"> <text>Failure to qualify as a facility, as defined in §B(15) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(13)"> <text>“Eligible person” means an individual who meets facility admission criteria.</text> </paragraph> <paragraph num="(14)"> <text>“Eligible work” means work for which the use of State funds is authorized under the Act.</text> </paragraph> <paragraph num="(15)"> <text>“Facility” means a building that is wholly owned by and operated under the authority of a federally qualified health center.</text> </paragraph> <paragraph num="(16)"> <text>“Federally qualified health center” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Grant” means any funds competitively awarded from any source to the applicant including a State grant.</text> </paragraph> <paragraph num="(18)"> <text>“Grantee” means a federally qualified health center that receives State grant funds under the Act, which are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(19)"> <text>“Nonprofit organization” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the unit within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Operating costs” means costs associated with the operation of a federally qualified health center.</text> </paragraph> <paragraph num="(22)"> <text>“Project” means a proposed scope of work for the conversion, acquisition, renovation, equipping or construction of a facility.</text> </paragraph> <paragraph num="(23)"> <text>“Qualified entity” means:</text> <paragraph num="(a)"> <text>An entity designated as a federally qualified health center;</text> </paragraph> <paragraph num="(b)"> <text>A nonprofit organization seeking a “new start” status;</text> </paragraph> <paragraph num="(c)"> <text>A federally qualified health center applying for a new site designation; or</text> </paragraph> <paragraph num="(d)"> <text>A federally qualified health center applying for a “change of scope” under the Federal Public Health Service Act, §330 (42 U.S.C. §254b) that:</text> <paragraph num="(i)"> <text>Has been invited by the Health Resources Services Administration to submit a full application for federally qualified health center designation; and</text> </paragraph> <paragraph num="(ii)"> <text>Seeks to obtain State grant funds under the Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Renovation” means restoration or modernization, or both, to an existing or proposed Federally Qualified Health Center.</text> </paragraph> <paragraph num="(25)"> <text>“Retroactive expenditure” means any cost incurred or contracted for before the application for conversion, construction, acquisition, renovation, and equipment has been received and approved by the Secretary.</text> </paragraph> <paragraph num="(26)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(27)"> <text>“State grant” means State funds awarded under the Federally Qualified Health Centers Grant Program, unless the context clearly implies otherwise.</text> </paragraph> <paragraph num="(28)"> <text>“Wholly owned” includes leased property, if the lease agreement:</text> <paragraph num="(a)"> <text>Is for a minimum of 15 years following the project completion or extends the right of purchase to the lessee; and</text> </paragraph> <paragraph num="(b)"> <text>Includes a consent to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-1306, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of State Grant Funds."> <text>State grant funds for federally qualified health centers shall be used solely for approved projects that involve:</text> <paragraph num="A."> <text>Conversion of public buildings or parts of buildings;</text> </paragraph> <paragraph num="B."> <text>Acquisition of existing buildings or parts of buildings;</text> </paragraph> <paragraph num="C."> <text>Renovation of a facility;</text> </paragraph> <paragraph num="D."> <text>Purchase of capital equipment; or</text> </paragraph> <paragraph num="E."> <text>Planning, design, and construction of a facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligible Applicants for State Grant Funds."> <text>To be eligible to apply for State grant funds under the Act, an applicant shall:</text> <paragraph num="A."> <text>Be a qualified entity;</text> </paragraph> <paragraph num="B."> <text>Sponsor a project involving work specified in Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="C."> <text>Certify that the proposed facility will meet the handicap-accessibility requirements of 42 U.S.C. 12101 et seq., or provide a certified waiver from the Department of Housing and Community Development.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall apply for a State grant by completing an application with the Department on a form provided by the Department, and shall file the completed application for State grant funds with the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> <paragraph num="B."> <text>The Department shall provide any notice and information to the State Clearinghouse for Intergovernmental Assistance that may be required under COMAR 14.24.04.</text> </paragraph> <paragraph num="C."> <text>The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application.</text> </paragraph> <paragraph num="D."> <text>At the time of filing the application, the applicant shall file a written statement with the Department containing the following information or material:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel;</text> </paragraph> <paragraph num="(3)"> <text>Expenses incurred, or to be incurred, in carrying out qualified facility operations;</text> </paragraph> <paragraph num="(4)"> <text>Schedule of rates charged, or to be charged, for services rendered at the facility;</text> </paragraph> <paragraph num="(5)"> <text>Agreement to admit eligible persons on the basis of their need for services without regard to race, religion, national origin, color, or disability;</text> </paragraph> <paragraph num="(6)"> <text>If an applicant is currently operating as a federally qualified health center, a certified, audited profit-and-loss statement and balance sheet for the most current year;</text> </paragraph> <paragraph num="(7)"> <text>If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility; and</text> </paragraph> <paragraph num="(8)"> <text>Letter from Health Resources Services Administration (HRSA) granting federally qualified health center status to the nonprofit and designated site or a letter from HRSA stating that the “need” score in the applicant's letter of intent is competitive and invites the applicant to submit a full application for designation as a federally qualified health center.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Secretary shall approve applications that meet the requirements of this regulation and that set forth the priorities of the Department as stipulated in the annual application instructions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Amount of State Grant Awards."> <text>The Department shall determine the amount of the State grant, if any, for an applicant's approved project after consideration of the following:</text> <paragraph num="A."> <text>All approved applications;</text> </paragraph> <paragraph num="B."> <text>Priorities of need as established by the Department;</text> </paragraph> <paragraph num="C."> <text>The total unallocated State funds available in the Department's Administration-Sponsored Capital Programs for federally qualified health centers;</text> </paragraph> <paragraph num="D."> <text>The projected amount of anticipated appropriations as provided in the Governor's Five-Year Capital Improvement Program;</text> </paragraph> <paragraph num="E."> <text>The reasonableness of the total cost of the project; and</text> </paragraph> <paragraph num="F."> <text>Current operating costs or the reasonableness of a projected budget and revenues for the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recommendation of State Grant Awards."> <paragraph num="A."> <text>The Department shall determine whether the application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following:</text> <paragraph num="(1)"> <text>The availability of State grant funds;</text> </paragraph> <paragraph num="(2)"> <text>The receipt of satisfactory evidence from the applicant of the following requirements:</text> <paragraph num="(a)"> <text>Sufficient total financial contribution to complete the project;</text> </paragraph> <paragraph num="(b)"> <text>Control of site, such as deed or lease;</text> </paragraph> <paragraph num="(c)"> <text>Compliance with applicable local zoning requirements;</text> </paragraph> <paragraph num="(d)"> <text>Certified bid tabulation, construction contract, contract of sale, or 30-year lease agreement with landlord, contingent upon Board of Public Works approval; and</text> </paragraph> <paragraph num="(e)"> <text>Compliance with all other applicable provisions of State or federal law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Upon satisfactory completion of §A of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report stating that:</text> <paragraph num="(1)"> <text>A notice, including information in the application, has been provided to the State Clearinghouse for Intergovernmental Assistance;</text> </paragraph> <paragraph num="(2)"> <text>The application has been approved by the Secretary;</text> </paragraph> <paragraph num="(3)"> <text>The amount of a federal grant, if any is involved, that has been awarded to the applicant;</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>Use of Federal Grants.</text> <paragraph num="(1)"> <text>Any federal grant that is received for an eligible project shall be applied first to the cost of the project.</text> </paragraph> <paragraph num="(2)"> <text>Community Development Block Grants are considered as local matching funds and are not considered as federal grant funds.</text> </paragraph> <paragraph num="(3)"> <text>All other sources of funds shall be expended before any or all of the State grant is expended on an approved project.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limits of State Grant.</text> <paragraph num="(1)"> <text>Except as provided in §D of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal grants have been applied.</text> </paragraph> <paragraph num="(2)"> <text>A State grant may not be used to fund participation in retroactive expenditures.</text> </paragraph> <paragraph num="(3)"> <text>A State grant may include only those costs incurred or obligations contracted for eligible work after the application has been approved by the Secretary.</text> </paragraph> <paragraph num="(4)"> <text>Costs necessary and appropriate for filing an application, such as appraisals, surveys, and test borings, shall be paid by the applicant. These costs may be approved for funding by the Board of Public Works, if the project is approved by the Board of Public Works.</text> </paragraph> <paragraph num="(5)"> <text>State grant funds may not be used to pay the following costs:</text> <paragraph num="(a)"> <text>Closing costs;</text> </paragraph> <paragraph num="(b)"> <text>Noncapital equipment;</text> </paragraph> <paragraph num="(c)"> <text>Consultant services;</text> </paragraph> <paragraph num="(d)"> <text>Land;</text> </paragraph> <paragraph num="(e)"> <text>Off-site improvements; and</text> </paragraph> <paragraph num="(f)"> <text>Amounts that exceed the appraised value of the real property.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Exceptions on State Grant Limits. A project designated as eligible for poverty area funding under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal grants have been applied.</text> </paragraph> <paragraph num="D."> <text>Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if:</text> <paragraph num="(1)"> <text>The project is designated as eligible for poverty area funding under applicable federal regulations and State plans or Departmental regulations; and</text> </paragraph> <paragraph num="(2)"> <text>The majority of individuals served by the facility:</text> <paragraph num="(a)"> <text>Are enrolled in the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(b)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(c)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Funding Contribution Requirements.</text> <paragraph num="(1)"> <text>The grantee shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>The grantee shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works.</text> </paragraph> <paragraph num="(3)"> <text>A grantee may not expend the State grant award before other sources of funds are expended.</text> </paragraph> <paragraph num="(4)"> <text>The Department may not consider as contributions:</text> <paragraph num="(a)"> <text>Real or personal property;</text> </paragraph> <paragraph num="(b)"> <text>In-kind contributions; or</text> </paragraph> <paragraph num="(c)"> <text>Funds expended before an application is approved by the Secretary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Prohibition Against Use of the Project for Purposes Other Than Federally Qualified Health Center.</text> <paragraph num="(1)"> <text>A grantee may not use a project funded by a State grant:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction or services;</text> </paragraph> <paragraph num="(b)"> <text>As a place of sectarian religious worship or instruction;</text> </paragraph> <paragraph num="(c)"> <text>In connection with any program or department of divinity for any religious denomination; or</text> </paragraph> <paragraph num="(d)"> <text>For any purpose other than a federally qualified health center.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant have been used, or are being used, for a purpose prohibited by the Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Use of Funds for Acquisition and Renovation."> <paragraph num="A."> <text>If the applicant is acquiring a site with existing improvements, and the existing improvements are to be renovated for or used for a federally qualified health center, the total project costs may be eligible for State participation.</text> </paragraph> <paragraph num="B."> <text>In the circumstances outlined in §A of this regulation, at least two State-approved appraisers shall provide appraisals of the site and existing improvements to be acquired. State participation shall be limited to the lesser of the appraised value approved by the Department of General Services based upon the appraisals or the actual acquisition cost.</text> </paragraph> <paragraph num="C."> <text>If an applicant proposes to acquire an unimproved land site on which to construct a facility, the cost of the land is not eligible for State participation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of a federally qualified health center involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material:</text> <paragraph num="(a)"> <text>A recent certified, audited profit-and-loss statement and balance sheet for the facility;</text> </paragraph> <paragraph num="(b)"> <text>The volume of service at the federally qualified health center, such as days of service rendered to clients; and</text> </paragraph> <paragraph num="(c)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For 30 years following the completion of a project that receives poverty funding under Regulation .08D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving designated poverty-area clients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project; and</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The grantee shall provide builders’ risk insurance coverage during the entire period of project construction or renovation up to and including the owner’s acceptance of the building that:</text> <paragraph num="(a)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>Protects the State's interest in the building;</text> </paragraph> <paragraph num="(c)"> <text>Provides an amount at least equal to the replacement cost of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of a project, the grantee shall maintain, for 30 years, an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division.</text> </paragraph> </paragraph> <paragraph num="C."> <text>During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, heirs, or assigns.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion, and Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall notify the Secretary promptly and in any event, not later than 30 days after the applicant knew or should have reasonably have known that the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation of the State Grant by the Maryland legislature.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For good cause the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time.</text> </paragraph> <paragraph num="(3)"> <text>Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of an additional 180 days to encumber funds.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be released until the applicant:</text> <paragraph num="(1)"> <text>Has recorded a notice of the State's Right of Recovery, as approved by the Secretary, in the land records of the county or Baltimore City in which the property is located; and</text> </paragraph> <paragraph num="(2)"> <text>Is in compliance with this chapter and all applicable federal and State laws.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under the Act;</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Department's Office of Health Care Quality; and</text> </paragraph> <paragraph num="(4)"> <text>Take other action as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Right of Recovery."> <text>In the event of default under the terms of the Act and this chapter, a federally qualified health center financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 24, 2006 (33:8 Md. R. 732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> </annotations> </chapter> <chapter num="06" heading="Construction Funds for Conversion of Nursing Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the administration of State grant funds for any county, municipal corporation, or nonprofit organization for the conversion of nursing facility beds to provide other health care services under the Nursing Facility Conversion Grant Program, Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>It is the intent of the Department that State grant funds be used:</text> <paragraph num="(1)"> <text>To assist eligible applicants with the conversion of existing nursing facilities eligible under the Act in accordance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>After the applicant has secured all funds available from other sources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of converting nursing facility beds to provide other health care services determined appropriate by the Department.</text> </paragraph> <paragraph num="(2)"> <text>“Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any.</text> </paragraph> <paragraph num="(3)"> <text>“Applicant” means a county, municipal corporation, or nonprofit organization that has submitted an application.</text> </paragraph> <paragraph num="(4)"> <text>“Application” means the forms required and published by the Department, and submitted by the applicant to the Office of Capital Planning, Budgeting, and Engineering Services, to apply for a State grant for a project.</text> </paragraph> <paragraph num="(5)"> <text>“Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Building” means all or part of an existing nursing facility;</text> </paragraph> <paragraph num="(7)"> <text>“Capital equipment” means items that:</text> <paragraph num="(a)"> <text>With normal maintenance, have a life expectancy of at least 15 years;</text> </paragraph> <paragraph num="(b)"> <text>Have durable construction; and</text> </paragraph> <paragraph num="(c)"> <text>Are necessary to furnish a new health service not previously provided by the facility.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Construction” means an addition to an existing nursing facility building that results in the reduction of comprehensive care beds and therefore, the provision of other health care services.</text> </paragraph> <paragraph num="(9)"> <text>“Conversion” means the work required to modify or adapt the interior arrangement and other physical characteristics of an existing nursing facility building, in order to transform the facility or part of the facility for uses as stipulated in the annual application instructions.</text> </paragraph> <paragraph num="(10)"> <text>“Default” means:</text> <paragraph num="(a)"> <text>Transfer of property to any person, agency, or organization that would not qualify as an applicant or that is not approved as a transferee by the Board of Public Works;</text> </paragraph> <paragraph num="(b)"> <text>Failure to complete a project and to obtain required occupancy permit;</text> </paragraph> <paragraph num="(c)"> <text>Failure to provide a new health service and commence operation within 1 year after obtaining an occupancy permit;</text> </paragraph> <paragraph num="(d)"> <text>Failure to de-license a specified number of comprehensive nursing home beds; or</text> </paragraph> <paragraph num="(e)"> <text>Failure to provide approved health care service upon which a grant was predicated for a period of 30 years after the completion of project.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(12)"> <text>“Eligible person” means an individual who meets facility admission criteria.</text> </paragraph> <paragraph num="(13)"> <text>“Eligible work” means that work for which the use of State funds is authorized under the Act.</text> </paragraph> <paragraph num="(14)"> <text>“Facility” means:</text> <paragraph num="(a)"> <text>A facility that meets the definition of Health-General Article, §19-1401(e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A facility that is licensed by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>A nursing facility that is wholly owned by and operated under the authority of:</text> <paragraph num="(i)"> <text>A county or a municipal corporation, or both; or</text> </paragraph> <paragraph num="(ii)"> <text>A nonprofit nursing facility that is wholly owned by and operated under the authority of a nonprofit organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Grant” means any funds competitively awarded from any source to the applicant including a State grant.</text> </paragraph> <paragraph num="(16)"> <text>“Grantee” means a nursing facility that receives State grant funds under the Act, which are approved by the Board of Public Works.</text> </paragraph> <paragraph num="(17)"> <text>“Nonprofit organization” has the meaning stated in Health-General Article, §24-1401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Office of Capital Planning, Budgeting, and Engineering Services” means the unit within the Department designated by the Secretary to administer this chapter.</text> </paragraph> <paragraph num="(19)"> <text>“Operating costs” means costs associated with the operation of the new service.</text> </paragraph> <paragraph num="(20)"> <text>“Other health care services” means those health care services determined appropriate by the Department as stipulated in the annual grant application instructions.</text> </paragraph> <paragraph num="(21)"> <text>“Project” means the approved proposed scope of work by the Department for the renovation, construction, and equipping of a facility in order to convert existing nursing facility bed space for other health care services.</text> </paragraph> <paragraph num="(22)"> <text>“Renovation” means restoration or modernization of space that results in the reduction of comprehensive care beds in an existing nursing facility.</text> </paragraph> <paragraph num="(23)"> <text>“Retroactive expenditure” means any cost incurred or contracted for before the application for conversion has been received and approved by the Secretary.</text> </paragraph> <paragraph num="(24)"> <text>“Secretary” means the Secretary of Health, or a designated representative.</text> </paragraph> <paragraph num="(25)"> <text>“State grant” means State funds awarded under the Nursing Facility Conversion Grant Program.</text> </paragraph> <paragraph num="(26)"> <text>“Wholly owned” has the meaning stated in Health-General Article, §24-1401, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of State Grant Funds."> <text>State grant funds for nursing facilities under the Act shall be used solely for projects approved by the Department for the purpose of converting existing nursing facility beds to provide:</text> <paragraph num="A."> <text>Other health care services;</text> </paragraph> <paragraph num="B."> <text>Purchase of capital equipment; and</text> </paragraph> <paragraph num="C."> <text>Planning, design, construction, and renovation of a facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligible Applicants for State Grant Funds."> <paragraph num="A."> <text>To be eligible to apply for State grant funds under the Act, an applicant shall:</text> <paragraph num="(1)"> <text>Be a county, municipal corporation, or a nonprofit organization;</text> </paragraph> <paragraph num="(2)"> <text>Have a proposed project that is in accord with the priorities of the Secretary;</text> </paragraph> <paragraph num="(3)"> <text>Be licensed by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Be eligible for certification under, and agree to participate in, Title XVIII and Title XIX of the Social Security Act;</text> </paragraph> <paragraph num="(5)"> <text>Certify that the proposed facility will meet the accessibility requirements of 42 U.S.C. 12101 et seq., or provide a certified waiver from the Department of Housing and Community Development;</text> </paragraph> <paragraph num="(6)"> <text>Not have had any of the following deficiencies cited in any survey conducted by the Department's Office of Health Care Quality during the calendar year preceding the grant application year, using the scope and severity matrix found in the Centers for Medicare and Medicaid Services State Operations Manual for Survey and Certification, Part 7, §7400E:</text> <paragraph num="(a)"> <text>Two or more “G” level deficiencies; or</text> </paragraph> <paragraph num="(b)"> <text>One or more “H” or higher-level deficiencies; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Be approved by the Secretary to receive a grant award.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A provider operating a facility with any of the deficiencies described in §A(6) of this regulation may be eligible to apply for a grant if the facility has undergone a change in ownership as a result of an arm's length transaction as determined by the Department, since the latest survey that resulted in the deficiencies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedure."> <paragraph num="A."> <text>An applicant shall apply for a State grant by:</text> <paragraph num="(1)"> <text>Completing an application with the Department on a form provided by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Filing the completed application for State grant funds with the Office of Capital Planning, Budgeting, and Engineering Services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall provide any notice and information to the State Clearinghouse for intergovernmental review that may be required under COMAR 14.24.04.</text> </paragraph> <paragraph num="C."> <text>The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application.</text> </paragraph> <paragraph num="D."> <text>At the time of filing the application, the applicant shall file a written statement with the Department containing the following information or material:</text> <paragraph num="(1)"> <text>Current or intended program of services;</text> </paragraph> <paragraph num="(2)"> <text>The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel;</text> </paragraph> <paragraph num="(3)"> <text>Expenses incurred, or to be incurred, in carrying out qualified facility operations;</text> </paragraph> <paragraph num="(4)"> <text>Schedule of rates charged, or to be charged, for services rendered at the facility;</text> </paragraph> <paragraph num="(5)"> <text>Agreement to admit eligible persons on the basis of their need for services without regard to race, national origin, color, or disability;</text> </paragraph> <paragraph num="(6)"> <text>A certified, audited profit-and-loss statement and balance sheet for the most current year; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion of the conversion of the facility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Secretary shall recommend to the Board of Public Works applications that:</text> <paragraph num="(1)"> <text>Meet the requirements of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Set forth the priorities of the Department as stipulated in the annual application instructions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Amount of State Grant Awards."> <text>The Department shall determine the amount of the State grant, if any, for an applicant's approved project after consideration of the following:</text> <paragraph num="A."> <text>All approved applications;</text> </paragraph> <paragraph num="B."> <text>Priorities of need as established by the Department;</text> </paragraph> <paragraph num="C."> <text>The total unallocated State funds available for grants under the Act;</text> </paragraph> <paragraph num="D."> <text>The projected amount of anticipated appropriations as provided in the Governor's Five-Year Capital Improvement Program;</text> </paragraph> <paragraph num="E."> <text>The reasonableness of the total cost of the project; and</text> </paragraph> <paragraph num="F."> <text>Current operating costs or the reasonableness of a projected budget and revenues for the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recommendation of State Grant Awards."> <paragraph num="A."> <text>The Department shall determine whether the application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following:</text> <paragraph num="(1)"> <text>The availability of State grant funds;</text> </paragraph> <paragraph num="(2)"> <text>The receipt of satisfactory evidence from the applicant of the following requirements:</text> <paragraph num="(a)"> <text>Documentation from the Maryland Health Care Commission that:</text> <paragraph num="(i)"> <text>A certificate of need is not required for a decrease in bed capacity or conversion to an alternative health care facility or service proposed by the project; or</text> </paragraph> <paragraph num="(ii)"> <text>An applicant has obtained a certificate of need, if required pursuant to Health-General Article, §19-120, Annotated Code of Maryland, for the proposed changes in bed capacity or license category, or to establish the new health care facility or service;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Sufficient total financial contribution to complete the project;</text> </paragraph> <paragraph num="(c)"> <text>Control of site, such as deed or lease;</text> </paragraph> <paragraph num="(d)"> <text>Compliance with applicable local zoning requirements;</text> </paragraph> <paragraph num="(e)"> <text>Certified bid tabulation, construction contract; and</text> </paragraph> <paragraph num="(f)"> <text>Compliance with all other applicable provisions of State or federal law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Upon satisfactory completion of §A of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report stating that:</text> <paragraph num="(1)"> <text>A notice, including information in the application, has been provided to the State Clearinghouse;</text> </paragraph> <paragraph num="(2)"> <text>The application has been approved by the Secretary; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of a federal grant, if any is involved, that has been awarded to the applicant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Grant Limitations and Provisions."> <paragraph num="A."> <text>Use of Federal Grants.</text> <paragraph num="(1)"> <text>Any federal grant that is received for an eligible project shall be applied first to the cost of the project.</text> </paragraph> <paragraph num="(2)"> <text>Community development block grants are considered as local matching funds and are not considered as federal grant funds.</text> </paragraph> <paragraph num="(3)"> <text>All other sources of funds shall be expended before any or all of the State grant is expended on an approved project.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limits of State Grant.</text> <paragraph num="(1)"> <text>Except as provided in §D of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal grants have been applied.</text> </paragraph> <paragraph num="(2)"> <text>A State grant may not be used to fund participation in retroactive expenditures.</text> </paragraph> <paragraph num="(3)"> <text>A State grant may include only those costs incurred or obligations contracted for eligible work after the application has been approved by the Secretary.</text> </paragraph> <paragraph num="(4)"> <text>State grant funds may not be used to pay the following costs:</text> <paragraph num="(a)"> <text>Noncapital equipment;</text> </paragraph> <paragraph num="(b)"> <text>Consultant services; or</text> </paragraph> <paragraph num="(c)"> <text>Off-site improvements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Exceptions on State Grant Limits. A project designated as eligible for poverty area funding under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal grants have been applied.</text> </paragraph> <paragraph num="D."> <text>Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if:</text> <paragraph num="(1)"> <text>The project is designated as eligible for poverty area funding under applicable federal regulations and State plans or Departmental regulations; and</text> </paragraph> <paragraph num="(2)"> <text>The majority of individuals served by the facility:</text> <paragraph num="(a)"> <text>Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance;</text> </paragraph> <paragraph num="(b)"> <text>Are eligible for Supplemental Security Income benefits; or</text> </paragraph> <paragraph num="(c)"> <text>Have income levels which do not exceed 150 percent of the federal poverty level.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Funding Contribution Requirements.</text> <paragraph num="(1)"> <text>The grantee shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award.</text> </paragraph> <paragraph num="(2)"> <text>The grantee shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works.</text> </paragraph> <paragraph num="(3)"> <text>A grantee may not expend the State grant award before other sources of funds are expended.</text> </paragraph> <paragraph num="(4)"> <text>The Department may not consider as contributions:</text> <paragraph num="(a)"> <text>Real or personal property;</text> </paragraph> <paragraph num="(b)"> <text>In-kind contributions; or</text> </paragraph> <paragraph num="(c)"> <text>Funds expended before an application is approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A grantee may not use a project funded by a State grant primarily:</text> <paragraph num="(a)"> <text>For the furtherance of sectarian religious instruction or services;</text> </paragraph> <paragraph num="(b)"> <text>As a place of sectarian religious worship or instruction;</text> </paragraph> <paragraph num="(c)"> <text>In connection with any program or department of divinity for any religious denomination.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant have been, or are being, used for a purpose prohibited by the Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Residual Requirements of the Grantee."> <paragraph num="A."> <text>Annual Requirements.</text> <paragraph num="(1)"> <text>For a period of 30 years following the conversion of nursing facility beds involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material:</text> <paragraph num="(a)"> <text>A recent certified, audited profit-and-loss statement and balance sheet for the facility;</text> </paragraph> <paragraph num="(b)"> <text>Volume of service in the portion of the building converted with State grant funds, such as days of service rendered to clients; and</text> </paragraph> <paragraph num="(c)"> <text>Other supplemental information required by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a period of 30 years following the completion of a project that receives poverty funding under Regulation .08D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving designated poverty-area clients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Insurance Requirements.</text> <paragraph num="(1)"> <text>Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project; and</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The grantee shall provide builders' risk insurance coverage during the entire period of project construction or renovation up to and including owner's acceptance of building that:</text> <paragraph num="(a)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(b)"> <text>Protects the State's interest in the building;</text> </paragraph> <paragraph num="(c)"> <text>Provides an amount at least equal to the replacement cost of the facility; and</text> </paragraph> <paragraph num="(d)"> <text>Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of a project, the grantee shall maintain, for a period of 30 years, an all-risk insurance policy that:</text> <paragraph num="(a)"> <text>Provides coverage for an amount at least equal to the replacement cost of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Names the State as a loss payee;</text> </paragraph> <paragraph num="(c)"> <text>Protects the State's interest in the project;</text> </paragraph> <paragraph num="(d)"> <text>Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any:</text> <paragraph num="(i)"> <text>Cancellation of policy;</text> </paragraph> <paragraph num="(ii)"> <text>Material loss covered by the policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Material changes in the policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer's Office, Insurance Division.</text> </paragraph> </paragraph> <paragraph num="C."> <text>During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, heirs, or assigns.</text> </paragraph> <paragraph num="D."> <text>Extension of Time for Completion; Other Changes.</text> <paragraph num="(1)"> <text>The applicant shall notify the Secretary promptly and, in any event, not more than 30 days after the applicant knew or should reasonably have known that the applicant is unable to encumber funds:</text> <paragraph num="(a)"> <text>In the manner approved by the Secretary; or</text> </paragraph> <paragraph num="(b)"> <text>Within 2 years of the appropriation by the Maryland General Assembly.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For good cause, the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time.</text> </paragraph> <paragraph num="(3)"> <text>Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of up to an additional 180 days to encumber funds.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expenditures. State funds may not be released until:</text> <paragraph num="(1)"> <text>The applicant has recorded a notice of the State's right of recovery, as approved by the Secretary, in the land records of Baltimore City or the county in which the property is located; and</text> </paragraph> <paragraph num="(2)"> <text>The applicant is in compliance with this chapter and all applicable federal and State laws.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may:</text> <paragraph num="(1)"> <text>Refuse to consider the grantee for any future funding under the Act;</text> </paragraph> <paragraph num="(2)"> <text>Require an audit of the grantee;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Department's Office of Health Care Quality; and</text> </paragraph> <paragraph num="(4)"> <text>Take other action as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Right of Recovery."> <text>In the event of default under the terms of the Act and this chapter, a nursing facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 13, 2007 (34:16 Md. R. 1432)</annotation> </annotations> </chapter> </subtitle> <subtitle num="09" heading="Medical Care Programs"> <chapter num="01" heading="Advanced Practice Nurse Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced practice nurse” means a:</text> <paragraph num="(a)"> <text>Certified nurse practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Certified nurse midwife; or</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse anesthetist.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland State Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Certified nurse midwife (CNM)” means a registered nurse who is:</text> <paragraph num="(a)"> <text>Certified by the Board to practice nurse midwifery under COMAR 10.27.05;</text> </paragraph> <paragraph num="(b)"> <text>Certified by the American College of Nurse-Midwives; or</text> </paragraph> <paragraph num="(c)"> <text>Certified by the American Midwifery Certification Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Certified nurse practitioner” means:</text> <paragraph num="(a)"> <text>A registered nurse who, by reason of certification under COMAR 10.27.07, may practice in Maryland as a nurse practitioner under the terms of that chapter; or</text> </paragraph> <paragraph num="(b)"> <text>If out-of-State, a registered nurse who qualifies as a nurse practitioner in the state in which services are provided.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Certified registered nurse anesthetist (CRNA)” means a registered nurse who is certified to practice nurse anesthesia by the Board under COMAR 10.27.06.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(7)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(9)"> <text>“Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02.</text> </paragraph> <paragraph num="(10)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(11)"> <text>“Provider” means an advanced practice nurse who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License and Certification Requirements."> <paragraph num="A."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Meet all license requirements as set forth in COMAR 10.09.36.02; and</text> </paragraph> <paragraph num="(2)"> <text>Be licensed and hold all certifications as required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If practicing out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, a provider shall:</text> <paragraph num="A."> <text>Meet all conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="B."> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>Subject to §B of this regulation, the Program covers medically necessary services rendered to participants as follows:</text> <paragraph num="(1)"> <text>For nurse practitioners:</text> <paragraph num="(a)"> <text>Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.07; or</text> </paragraph> <paragraph num="(b)"> <text>If out-of-State, nurse practitioner services authorized in the state in which the services are provided;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For nurse midwives:</text> <paragraph num="(a)"> <text>Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or</text> </paragraph> <paragraph num="(b)"> <text>If out-of-State, nurse midwife services authorized in the state in which the services are provided;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For certified registered nurse anesthetists:</text> <paragraph num="(a)"> <text>Medically necessary services within the provider’s scope of practice and in collaboration with an authorized provider as described in COMAR 10.27.06; or</text> </paragraph> <paragraph num="(b)"> <text>If out-of-State, certified registered nurse anesthetist services authorized in the state in which the services are provided;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Laboratory services when the advanced practice nurse is not required to register their office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(5)"> <text>Drugs and supplies within the advanced practice nurse’s scope of practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The services in §A of this regulation shall be:</text> <paragraph num="(1)"> <text>Medically necessary; and</text> </paragraph> <paragraph num="(2)"> <text>Described in the participant’s medical record in sufficient detail to support the invoice submitted for those services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Under this chapter, the Program does not cover the following:</text> <paragraph num="A."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="B."> <text>Services prohibited by the Maryland Nurse Practice Act or by the Board;</text> </paragraph> <paragraph num="C."> <text>Advanced practice nursing services included as part of the cost of:</text> <paragraph num="(1)"> <text>An inpatient facility;</text> </paragraph> <paragraph num="(2)"> <text>A hospital outpatient department; or</text> </paragraph> <paragraph num="(3)"> <text>A freestanding clinic;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Visits by or to the provider solely for the purpose of the following:</text> <paragraph num="(1)"> <text>Prescription, drug, or food supplement pick-up;</text> </paragraph> <paragraph num="(2)"> <text>Recording of an electrocardiogram;</text> </paragraph> <paragraph num="(3)"> <text>Ascertaining the patient’s weight;</text> </paragraph> <paragraph num="(4)"> <text>Interpretation of laboratory tests or panels; or</text> </paragraph> <paragraph num="(5)"> <text>Prescribing or administering medication;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Drugs and supplies which are acquired by the provider at no cost;</text> </paragraph> <paragraph num="F."> <text>Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record;</text> </paragraph> <paragraph num="G."> <text>Services paid under the free-standing dialysis program as described in COMAR 10.09.22;</text> </paragraph> <paragraph num="H."> <text>Immunizations required for travel outside the continental United States;</text> </paragraph> <paragraph num="I."> <text>Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control;</text> </paragraph> <paragraph num="J."> <text>Acupuncture;</text> </paragraph> <paragraph num="K."> <text>Hypnosis;</text> </paragraph> <paragraph num="L."> <text>Travel expenses;</text> </paragraph> <paragraph num="M."> <text>Investigational or experimental drugs and procedures;</text> </paragraph> <paragraph num="N."> <text>Services denied by Medicare as not medically justified;</text> </paragraph> <paragraph num="O."> <text>Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service;</text> </paragraph> <paragraph num="P."> <text>Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and</text> </paragraph> <paragraph num="Q."> <text>For certified nurse midwives, a separate visit charge on date of delivery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment in the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all requests for payment not properly completed.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider's:</text> <paragraph num="(1)"> <text>Customary charge to the general public for similar services; and</text> </paragraph> <paragraph num="(2)"> <text>Acquisition cost for injectable drugs or dispensed medical supplies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by the Program; or</text> </paragraph> <paragraph num="(2)"> <text>The Program rates as described in COMAR 10.09.02.07.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a service is free to individuals not covered by the Program:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payments on Medicare claims are authorized, if:</text> <paragraph num="(1)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(2)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(3)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(4)"> <text>Medicare has determined that services were medically justified; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall make supplemental payments on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance shall be paid in full; and</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Program rate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Program may not make direct payment to participants.</text> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="K."> <text>The Program shall reimburse for all medical laboratory services according to the fees established under COMAR 10.09.09.</text> </paragraph> <paragraph num="L."> <text>An advanced practice nurse who is employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital.</text> </paragraph> <paragraph num="M."> <text>The Program may not reimburse nurse midwives for prenatal or postpartum care once the patient has been referred to a physician for completion of prenatal or postpartum care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Causes for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Note: For the current Medical Assistance Eligibility regulations, see COMAR 10.09.24 and 10.09.25.</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Effective date: May 1, 1975 (2:7 Md. R. 525)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Amended effective January 7, 1976 (3:1 Md. R. 41) and March 17, 1976 (3:6 Md. R. 358); amended as an emergency provision effective November 23, 1976 (3:26 Md. R. 1535)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Chapter revised effective April 27, 1977 (4:9 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .01CCC adopted effective November 23, 1977 (4:24 Md. R. 1805)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .02A amended as an emergency provision effective July 1, 1977 (4:13 Md. R. 1026); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .02A amended effective April 4, 1980 (7:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .02B amended effective November 23, 1977 (4:24 Md. R. 1805)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulations .04B, C and .05B amended effective October 3, 1980 (7:20 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .05C amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective November 10, 1977 (4:25 Md. R. 1910); adopted permanently effective March 10, 1978 (5:5 Md. R. 325)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .05C repealed effective October 3, 1980 (7:20 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .06B amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 14); adopted permanently effective May 5, 1978 (5:9 Md. R. 683)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .06B amended effective July 1, 1978 (5:13 Md. R. 1051)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .06B amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .06B amended effective July 1, 1980 (7:13 Md. R. 1278)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .06B amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1346); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .08A amended effective December 26, 1980 (7:26 Md. R. 2422)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulations .09 and .10B amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulations .10B and .11B amended effective December 28, 1979 (6:26 Md. R. 2073)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .10D repealed effective August 8, 1980 (7:16 Md. R. 1594)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .10D adopted as an emergency provision effective November 1, 1982 (8:21 Md. R. 1703); adopted permanently effective March 1, 1982 (9:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .11D amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805); amended effective December 1, 1978 (5:24 Md. R. 1797); amended effective December 28, 1979 (6:26 Md. R. 2073)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .12A amended as an emergency provision effective January 1, 1983 (10:3 Md. R. 207); emergency status extended at 10:8 Md. R. 720; emergency status expired April 30, 1983</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .16C amended effective October 3, 1980 (7:20 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .17 adopted effective February 14, 1983 (10:3 Md. R. 209)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .18A amended effective January 31, 1983 (10:2 Md. R. 109)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Regulation .18B adopted as an emergency provision effective July 26, 1982 (9:17 Md. R. 1696); emergency status extended at 9:23 Md. R. 2254; adopted permanently effective November 30, 1982 (9:23 Md. R. 2259)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Eligibility">Chapter repealed effective May 1, 1983 (10:6 Md. R. 558)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Effective date: May 14, 1990 (17:9 Md. R. 1090)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .01 amended effective May 31, 1999 (26:11 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .02C amended effective May 31, 1999 (26:11 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .05G, Q amended effective May 31, 1999 (26:11 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06 amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06C,D,G amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06E amended effective May 31, 1999 (26:11 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06F amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06K adopted effective May 31, 1999 (26:11 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulations .01—.10 under Nurse Practitioner Services repealed and new Regulations .01—.08 under Advanced Practice Nurse Services adopted effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .03 amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services">Regulation .06H, I amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> </annotations> </chapter> <chapter num="02" heading="Physicians' Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Attending physician” means a physician, other than a house officer, resident, intern, or emergency room physician, directly responsible for the patient's care.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Physician quality Assurance.</text> </paragraph> <paragraph num="(3)"> <text>“Consultant-specialist” means a licensed physician who meets one of the following criteria:</text> <paragraph num="(a)"> <text>Has been declared board certified by a member board of the American Board of Medical Specialties and currently retains that status;</text> </paragraph> <paragraph num="(b)"> <text>Can demonstrate satisfactory completion of a residency program accredited by the Liaison Committee for Graduate Medical Education, or the appropriate Residency Review Committee of the American Medical Association;</text> </paragraph> <paragraph num="(c)"> <text>Has been declared board certified by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association;</text> </paragraph> <paragraph num="(d)"> <text>Has been declared board eligible by a specialty board approved by the Advisory Board of Osteopathic Specialists;</text> </paragraph> <paragraph num="(e)"> <text>Can demonstrate, if a residency program was completed in a foreign country, that qualifications and training are acceptable for admission into the examination system of the appropriate American Specialty Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Consultation” means written opinion or advice rendered by a consultant-specialist whose opinion or advice is requested by the patient's attending physician for the further evaluation or management of the patient by the attending physician. If the consultant-specialist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant-specialist is not a consultation. The consultation shall be provided in the specialty in which the consultant-specialist is registered with the Program.</text> </paragraph> <paragraph num="(5)"> <text>“Cosmetic surgery” means surgery which can be expected to improve a patient's physical appearance, but does not restore or materially improve a body function.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(7)"> <text>“Direct supervision” means that a physician-employer is physically present in the same area of a facility as a nonphysician providing the service or services. A physician may supervise only two nonphysician practitioners at any given time.</text> </paragraph> <paragraph num="(8)"> <text>“Free-standing clinics” means those clinics not associated with a hospital which are under the direction of a physician or dentist.</text> </paragraph> <paragraph num="(9)"> <text>“Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(11)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(13)"> <text>“Medicare-Certified Facility” means one which is certified for Medicare by the regional office of the Health Care Financing Administration to furnish dialysis services directly to chronic kidney disease patients.</text> </paragraph> <paragraph num="(14)"> <text>“Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A.</text> </paragraph> <paragraph num="(15)"> <text>“Multispecialty setting” means that type of medical practice which exists in a teaching hospital or in a group practice which is composed of physicians with different specialties.</text> </paragraph> <paragraph num="(16)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(17)"> <text>“Patient” means a recipient awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(18)"> <text>“Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(19)"> <text>“Preauthorization” means an approval required from the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(20)"> <text>“Preoperative day” means an inpatient day in a general hospital before surgery for a patient admitted for a surgical procedure, or a day before surgery for a patient admitted for a nonsurgical service as an inpatient in a general hospital once the need for surgery has been established and the patient's condition is satisfactory for surgery.</text> </paragraph> <paragraph num="(21)"> <text>“Prescriber” means a physician, dentist, podiatrist, or other professional authorized to prescribe legend drugs and authorized by the Department to participate in the Program.</text> </paragraph> <paragraph num="(22)"> <text>“Prescription” means a written order for medication, or medical supplies or equipment, signed by the prescriber.</text> </paragraph> <paragraph num="(23)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(24)"> <text>“Provider” means an individual, association, partnership, or incorporated or unincorporated group of physicians duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(25)"> <text>“Referral” means a transfer of the patient from one physician to another for diagnosis and treatment of the condition for which the referral was made. The physician to whom the referral is made, whether a generalist or specialist, will be considered as the primary care physician and not as a consultant.</text> </paragraph> <paragraph num="(26)"> <text>“United States” means the 50 states, the District of Columbia, and the U.S. territories.</text> </paragraph> <paragraph num="(27)"> <text>“Utilization control agent (UCA)” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to professional standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.02 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="D."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a physicians’ services provider require that the provider:</text> <paragraph num="(1)"> <text>Shall submit documentation of consultant-specialist status if applying for that status;</text> </paragraph> <paragraph num="(2)"> <text>May not place a restriction on a participant’s right to select providers of his or her choice;</text> </paragraph> <paragraph num="(3)"> <text>May not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department;</text> </paragraph> <paragraph num="(4)"> <text>Shall agree to personally sign all requests for laboratory or other diagnostic services, or to require that copies of personally signed order sheets be supplied to participating providers of these services;</text> </paragraph> <paragraph num="(5)"> <text>Shall agree, when requesting laboratory or other diagnostic services, to supply his or her individual practitioner identification (rendering) number to those participating providers;</text> </paragraph> <paragraph num="(6)"> <text>Shall agree to identify by the individual physician practitioner's identification number each physician assistant who is authorized by the physician to request laboratory services; and</text> </paragraph> <paragraph num="(7)"> <text>Shall comply with the requirements for the delivery of mental health services in accordance with COMAR 10.09.59 and 10.67.08.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following medically necessary services rendered to participants:</text> <paragraph num="A."> <text>Physicians’ services rendered in the physician’s office, the participant’s home, a hospital, a skilled or intermediate care nursing facility, a freestanding clinic, or elsewhere when these services are:</text> <paragraph num="(1)"> <text>Performed by the physician or one of the following:</text> <paragraph num="(a)"> <text>Another licensed physician either in the physician's employ or one who renders services through a reciprocal agreement as a substitute physician,</text> </paragraph> <paragraph num="(b)"> <text>A certified registered physician's assistant, licensed registered nurse, certified psychologist, or a certified social worker, provided that the individual performing the service is in the physician's employ and is under the physician's direct supervision and performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of physicians' services,</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse midwife who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.05; and</text> </paragraph> <paragraph num="(d)"> <text>A certified nurse practitioner who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services;</text> </paragraph> <paragraph num="(3)"> <text>Adequately described in the participant’s medical record;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Consultations;</text> </paragraph> <paragraph num="C."> <text>Diagnostic procedures to include:</text> <paragraph num="(1)"> <text>Procedures related to the patient's medical needs;</text> </paragraph> <paragraph num="(2)"> <text>Laboratory services performed by a physician or personnel under the physician's direct supervision, when the physician is not required to register his office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Drugs dispensed by the physician within the limitations of COMAR 10.09.03;</text> </paragraph> <paragraph num="E."> <text>Injectable drugs administered by the provider within the limitations of COMAR 10.09.03;</text> </paragraph> <paragraph num="F."> <text>Medical equipment and supplies dispensed by the physician within the limitations of COMAR 10.09.12;</text> </paragraph> <paragraph num="G."> <text>Abortions performed in accordance with the Health-General Article, Title 20, Subtitles 1 and 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="H."> <text>Sterilizations when performed according to criteria contained in 42 Code of Federal Regulations §§441.250—441.258 and when the appropriate forms, as established by guideline, are properly completed and attached to the claim;</text> </paragraph> <paragraph num="I."> <text>Vaccine administrations when the vaccines:</text> <paragraph num="(1)"> <text>Meet the following conditions for coverage under the Vaccines for Children Program:</text> <paragraph num="(a)"> <text>Covered under the Vaccines for Children program;</text> </paragraph> <paragraph num="(b)"> <text>Administered to participants eligible for the Vaccines for Children program; and</text> </paragraph> <paragraph num="(c)"> <text>Administered by providers eligible to be reimbursed for vaccine administration under the Vaccines for Children program; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Are supplied to providers by the federal government at no charge, including but not limited to the administration of COVID-19 vaccinations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Services which are not covered are:</text> <paragraph num="(1)"> <text>Physician services not medically justified;</text> </paragraph> <paragraph num="(2)"> <text>Nonemergency dialysis services related to chronic kidney disorders unless they are provided in a Medicare-certified facility;</text> </paragraph> <paragraph num="(3)"> <text>Physician inpatient hospital services rendered during any period that is in excess of the length of stay authorized by the Utilization control agent (UCA);</text> </paragraph> <paragraph num="(4)"> <text>Physician services denied by Medicare as not medically necessary;</text> </paragraph> <paragraph num="(5)"> <text>Services which are investigational or experimental;</text> </paragraph> <paragraph num="(6)"> <text>Autopsies;</text> </paragraph> <paragraph num="(7)"> <text>Physician services included as part of the cost of an inpatient facility, hospital outpatient department, or free-standing clinics;</text> </paragraph> <paragraph num="(8)"> <text>Payment to physicians for specimen collections, except by venipuncture, and capillary or arterial puncture;</text> </paragraph> <paragraph num="(9)"> <text>Injectable medications, and visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the patient’s medical records;</text> </paragraph> <paragraph num="(10)"> <text>Vaccine administration unless covered under Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(11)"> <text>Visits solely to accomplish one or more of the following:</text> <paragraph num="(a)"> <text>Prescription, drug or food supplement pick-up, collection of specimens for laboratory procedures,</text> </paragraph> <paragraph num="(b)"> <text>Recording of an electrocardiogram,</text> </paragraph> <paragraph num="(c)"> <text>Ascertaining the patient's weight;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Interpretation of laboratory tests or panels;</text> </paragraph> <paragraph num="(13)"> <text>Medical Assistance prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control;</text> </paragraph> <paragraph num="(14)"> <text>Drugs and supplies dispensed by the physician which are acquired by the physician at no cost;</text> </paragraph> <paragraph num="(15)"> <text>Disposable medical supplies;</text> </paragraph> <paragraph num="(16)"> <text>Services prohibited by the Board of Physician Quality Assurance;</text> </paragraph> <paragraph num="(17)"> <text>Services which are provided outside the United States;</text> </paragraph> <paragraph num="(18)"> <text>Services which do not involve direct patient contact;</text> </paragraph> <paragraph num="(19)"> <text>Sterilization reversal procedures;</text> </paragraph> <paragraph num="(20)"> <text>Prescriptions for drugs written on prescription pads that do not prevent copying, modification, or counterfeiting;</text> </paragraph> <paragraph num="(21)"> <text>Physician-administered drugs from manufacturers that do not participate in the Federal Drug Rebate Program; and</text> </paragraph> <paragraph num="(22)"> <text>Any covered service that requires a preauthorization, including physician-administered drugs and injectable medications, that is rendered without an approved preauthorization from the Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preoperative evaluations for anesthesia are included in the fee for administration of anesthesia and the provider may not bill them as consultations.</text> </paragraph> <paragraph num="C."> <text>Referrals from one physician to another for treatment of specific patient problems may not be billed as consultations.</text> </paragraph> <paragraph num="D."> <text>The operating surgeon may not bill for the administration of anesthesia or for an assistant surgeon who is not in the operating surgeon's employ.</text> </paragraph> <paragraph num="E."> <text>Payment for consultations provided in a multispecialty setting is limited by criteria established by the Department.</text> </paragraph> <paragraph num="F."> <text>The Department will not pay a provider for those laboratory or x-ray services performed by another facility. The Department will pay directly the facility performing those services.</text> </paragraph> <paragraph num="G."> <text>The Program does not cover services rendered to an inpatient before one preoperative inpatient day, unless preauthorized by the Program.</text> </paragraph> <paragraph num="H."> <text>The provider may not bill the Program for services rendered under the supervising physician's provider number by an employed nonphysician extender, such as:</text> <paragraph num="(1)"> <text>A physical therapist;</text> </paragraph> <paragraph num="(2)"> <text>An occupational therapist;</text> </paragraph> <paragraph num="(3)"> <text>A speech language pathologist;</text> </paragraph> <paragraph num="(4)"> <text>An audiologist; or</text> </paragraph> <paragraph num="(5)"> <text>A nutritionist.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Services not rendered in-person shall comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The following procedures or services require preauthorization:</text> <paragraph num="(1)"> <text>Cosmetic surgery;</text> </paragraph> <paragraph num="(2)"> <text>Contact lens evaluation and fitting;</text> </paragraph> <paragraph num="(3)"> <text>Lipectomy and panniculectomy;</text> </paragraph> <paragraph num="(4)"> <text>Transplantations of vital organs;</text> </paragraph> <paragraph num="(5)"> <text>Services rendered to an inpatient before one preoperative day;</text> </paragraph> <paragraph num="(6)"> <text>Surgical procedures for the treatment of obesity;</text> </paragraph> <paragraph num="(7)"> <text>Surgical procedures for the purpose of gender reassignment; and</text> </paragraph> <paragraph num="(8)"> <text>Elective services from a noncontiguous state.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services which have been determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document medical necessity in a particular case. These services are found in the Medicare Carriers Manual, Part 3, Claims Process, Chapter II, Coverage Issues Appendix.</text> </paragraph> <paragraph num="C."> <text>Physicians dispensing or prescribing eyeglasses shall comply with the requirements of COMAR 10.09.14.</text> </paragraph> <paragraph num="D."> <text>The Department will preauthorize services when the provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> <paragraph num="E."> <text>Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. Non-Medicare claims require preauthorization according to §§A—D of this regulation.</text> </paragraph> <paragraph num="F."> <text>Physicians rendering mental health services shall comply with the preauthorization requirements of COMAR 10.09.70.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment on the form designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department.</text> </paragraph> <paragraph num="C."> <text>Except as provided in §F of this regulation, the Provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Maryland Medical Assistance Program's procedures for payment are contained in the following documents, the provisions of which are incorporated by reference:</text> <paragraph num="(1)"> <text>The Professional Services Provider Manual and Fee Schedule (Effective January 2024); and</text> </paragraph> <paragraph num="(2)"> <text>The Medical Laboratories Fee Schedule pursuant to COMAR 10.09.09.07D.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Except as provided in §F of this regulation, the Department will pay for covered services at the lesser of:</text> <paragraph num="(1)"> <text>Physician's customary charge or acquisition cost unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department's fees in accordance with §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Program shall reimburse providers up to the acquisition cost for diagnostic and therapeutic radiopharmaceuticals, contraceptive products and devices, and injectable medications when the provider submits documentation indicating that the acquisition cost of the product, device, or drug is greater than the reimbursement allowed in §E of this regulation.</text> </paragraph> <paragraph num="G."> <text>The Program reserves the right to negotiate and establish a different fee for a physician or a group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital's cost, provided this fee does not exceed limitations set forth in §E of this regulation.</text> </paragraph> <paragraph num="H."> <text>Supplemental payments on Medicare claims are made subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, and subject to the limitations of the State budget, coinsurance, shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare are payable according to §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Payments on Medicare claims are authorized if the:</text> <paragraph num="(1)"> <text>Provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The provider may not bill the Department or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Program will make no direct payment to participants.</text> </paragraph> <paragraph num="L."> <text>The Program will reimburse the provider for dispensed drugs at rates established in COMAR 10.09.03. The provider shall bill the Program in accordance with COMAR 10.09.03 using the Pharmacy Invoice.</text> </paragraph> <paragraph num="M."> <text>The Program will reimburse the provider for dispensed medical supplies at actual cost or at rates established by COMAR 10.09.12, whichever is less.</text> </paragraph> <paragraph num="N."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="O."> <text>Providers shall bill the Program in the following manner:</text> <paragraph num="(1)"> <text>A physician whose laboratory is not required to be registered pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under these regulations;</text> </paragraph> <paragraph num="(2)"> <text>A physician whose laboratory is registered as a medical laboratory pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under COMAR 10.09.09.</text> </paragraph> </paragraph> <paragraph num="P."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>The Program shall reimburse providers for all laboratory and other diagnostic services performed by a physician, or by authorized personnel under that physician's supervision, for that physician's patients.</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement shall be according to all applicable provisions of COMAR 10.10.06 and fees established according to §D of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Maximum reimbursement may not exceed the Medicare laboratory fee established by the Maryland Medicare carrier recognized by the Program.</text> </paragraph> <paragraph num="(4)"> <text>The Program shall reimburse providers for mental health services performed by a physician according to the fees established under COMAR 10.21.25 and the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, physician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a physician from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department may consult with the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The Department will give the findings and recommendations of this group consideration.</text> </paragraph> <paragraph num="D."> <text>The Department will give the provider reasonable notice of its intention to impose sanctions. In the written notice the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="E."> <text>A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards.</text> </paragraph> <paragraph num="F."> <text>If the Department determines that a provider participating in the Program as a case manager has violated any provision of the agreement executed under the terms of Regulation .03B of this chapter, the Program may suspend or disqualify the provider from participating as a case manager without otherwise restricting the provider’s participation as a physician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1967</annotation> <annotation type="History" subtype="Administrative History">Amended effective September 1, 1967; October 1, 1967; January 1, 1969; July 1, 1969; December 1, 1969; July 1, 1970; July 1, 1971; January 1, 1976 (2:29 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 adopted effective October 13, 1976 (3:21 Md. R. 1206); recodified as Regulation .11 on December 8, 1976 (3:25 Md. R. 1467)</annotation> <annotation type="History" subtype="Administrative History">Existing regulations repealed and new Regulations .01—.10 adopted effective December 8, 1976 (3:25 Md. R. 1467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04K, L adopted effective January 13, 1978 (5:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04K amended effective July 1, 1978 (5:12 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04L repealed effective July 1, 1978 (5:12 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F adopted effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended effective April 6, 1979 (6:7 Md. R. 676); repealed effective July 1, 1979 (6:13 Md. R. 1126)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective June 29, 1979 (6:13 Md. R. 1126)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 amended effective July 1, 1979 (6:13 Md. R. 1126)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A-1, A-2, A-3, N-2 adopted effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 15, 1990 (17:20 Md. R. 2426); December 29, 1997 (24:26 Md. R. 1757); March 6, 2000 (27:4 Md. R. 453)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .03B, .06, and .07Q amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1286) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01J-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01N-1 adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B adopted effective December 29, 1997 (24:26 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 6, 2000 (27:4 Md. R. 453); August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective October 1, 1985 (12:19 Md. R. 1848); December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I—K amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03O adopted effective October 15, 1990 (17:20 Md. R. 2426)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 17, 1981 (8:16 Md. R. 1365); December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 3, 2014 (41:2 Md. R. 91); August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) (adopted as Regulation .04K; recodified as Regulation .04G at 6:13 Md. R. 1126)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended as an emergency provision effective July 28, 1980 (7:16 Md. R. 1588); adopted permanently effective November 28, 1980 (7:24 Md. R. 2257)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04J adopted effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 12, 1985 (12:16 Md. R. 1606); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2902); December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); February 5, 2001 (28:2 Md. R. 99)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 23, 2014 (41:12 Md. R. 667); December 10, 2015 (42:24 Md. R. 1505); July 10, 2023 (50:13 Md. R. 512); June 24, 2024 (51:12 Md. R. 618)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05G and .06A adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H adopted effective October 15, 1990 (17:20 Md. R. 2426)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H repealed effective March 6, 2000 (27:4 Md. R. 453)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H adopted as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); adopted permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I adopted effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective June 20, 1983 (10:12 Md. R. 1072); February 9, 1987 (14:3 Md. R. 273); December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective October 10, 2016 (43:20 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F adopted effective December 29, 1997 (24:26 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 6, 2000 (27:4 Md. R. 453)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective December 18, 2003 (31:2 Md. R. 81); amended permanently effective April 26, 2004 (31:8 Md. R. 646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 14, 2021 (48:12 Md. R. 470); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective December 16, 1996 (23:25 Md. R. 1785)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, E, I amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); amended permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 6, 1982 (9:24 Md. R. 2390); May 1, 1983 (10:8 Md. R. 725); November 21, 1983 (10:23 Md. R. 2063)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective January 27, 1984 (11:4 Md. R. 312); emergency status expired May 26, 1984</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective May 27, 1984 (11:10 Md. R. 863)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective March 1, 1986 (13:6 Md. R. 668); emergency status expired June 30, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective June 2, 1986 (13:11 Md. R. 1273);</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1986 (13:12 Md. R. 1371); amended permanently effective December 1, 1986 (13:18 Md. R. 2020)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); amended permanently effective October 6, 1986 (13:20 Md. R. 2210)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 1, 1986 (13:22 Md. R. 2398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D repealed and new Regulation .07D adopted effective February 9, 1987 (14:3 Md. R. 273); amended effective October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903); January 1, 1989 (15:26 Md. R. 2983); July 1, 1989 (16:12 Md. R. 1335)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective September 8, 1989 (16:20 Md. R. 2178); adopted permanently effective January 1, 1990 (16:25 Md. R. 2710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 9, 1991 (18:24 Md. R. 2643)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 26, 1993 (20:23 Md. R. 1799); emergency status extended at 20:24 Md. R. 1863 and 21:11 Md. R. 949; emergency status expired July 4, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective July 4, 1994 (21:13 Md. R. 1156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183); emergency status expired April 30, 1995</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 5, 2001 (28:2 Md. R. 99)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2005 (32:17 Md. R. 1437); amended permanently effective October 24, 2005 (32:21 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective November 16, 2009 (36:23 Md. R. 1817); November 14, 2011 (38:23 Md. R. 1421); October 28, 2013 (40:21 Md. R. 1775); December 22, 2014 (41:25 Md. R. 1478); February 27, 2017 (44:4 Md. R. 252); August 28, 2017 (44:17 Md. R. 834); August 27, 2018 (45:17 Md. R. 803); December 31, 2018 (45:26 Md. R. 1241); October 7, 2019 (46:20 Md. R. 844); June 24, 2024 (51:12 Md. R. 618); June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J, M, N amended effective December 12, 1988 (15:25 Md. R. 2902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07O amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended effective December 29, 1997 (24:26 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07R adopted effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07S adopted effective December 16, 1996 (23:25 Md. R. 1785)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective December 12, 1988 (15:25 Md. R. 2902); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective March 1, 1982 (9:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective December 12, 1988 (15:25 Md. R. 2902): July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09F adopted effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09F amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> </annotations> </chapter> <chapter num="03" heading="Pharmacy Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>"340B price" means the price at which drugs are purchased as authorized under Section 340B of the Public Health Service Act.</text> </paragraph> <paragraph num="(2)"> <text>“Actual acquisition cost (AAC)” means the amount paid by a provider for a drug or product less all discounts, rebates, refunds, chargebacks, incentives, and price reductions.</text> </paragraph> <paragraph num="(3)"> <text>“Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription.</text> </paragraph> <paragraph num="(4)"> <text>“Approved unit dose system” means a drug distribution system approved by the Department that is used to prepare and distribute an individual, properly labeled dose of medication for a patient in a nursing facility.</text> </paragraph> <paragraph num="(5)"> <text>“Brand name drug” means:</text> <paragraph num="(a)"> <text>A single source drug;</text> </paragraph> <paragraph num="(b)"> <text>An innovator multiple source drug; or</text> </paragraph> <paragraph num="(c)"> <text>A drug submitted for payment as brand medically necessary.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Compounded prescription for intravenous therapy” means a prescription that:</text> <paragraph num="(a)"> <text>Combines two or more ingredients;</text> </paragraph> <paragraph num="(b)"> <text>Is prepared by using aseptic technique under a laminar flow clean bench; and</text> </paragraph> <paragraph num="(c)"> <text>Is administered to a patient intravenously.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Controlled substance” means a drug as defined under 21 U.S.C. §802.</text> </paragraph> <paragraph num="(8)"> <text>“Convenience package” means a smaller or specially packaged quantity of a product prepared for the convenience of a patient or provider as opposed to the regular packaging.</text> </paragraph> <paragraph num="(9)"> <text>“Copayment” means the amount a participant is liable to pay for prescriptions, when applicable, which is deducted from provider reimbursement.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX, Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(11)"> <text>“Diluent component” means a liquid used for reconstitution or dilution of an active ingredient in compounded prescription intravenous therapy.</text> </paragraph> <paragraph num="(12)"> <text>“Direct price” means, for drugs identified by the Program, the price charged by a pharmaceutical manufacturer to a dispensing pharmacy for a product supplied to the pharmacy without intermediate distribution charges, less any rebates, discounts, refunds, chargebacks, incentives, and price reductions.</text> </paragraph> <paragraph num="(13)"> <text>“Drugs” means legend drugs (those requiring a prescription under federal or State law) or over-the-counter (OTC) drugs (those not requiring a prescription under federal or State law).</text> </paragraph> <paragraph num="(14)"> <text>“Early and periodic screening, diagnosis, and treatment (EPSDT)” means a program of preventive health care services for Medical Assistance individuals younger than 21 years old.</text> </paragraph> <paragraph num="(15)"> <text>“EPSDT-related service” means diagnosis and treatment necessary to correct or manage health problems detected by a screening performed by a certified EPSDT provider. EPSDT-related services are rendered by a certified EPSDT provider or an appropriate Medical Assistance provider.</text> </paragraph> <paragraph num="(16)"> <text>“Family planning services” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health.</text> </paragraph> <paragraph num="(17)"> <text>“Federally qualified health center (FQHC)” means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act.</text> </paragraph> <paragraph num="(18)"> <text>“Federal supply schedule (FSS)” means the drug pricing program under the collection of multiple award contracts used by federal agencies, U.S. territories, Indian tribes, and other specified entities to purchase supplies and services from outside vendors.</text> </paragraph> <paragraph num="(19)"> <text>“Federal upper limit (FUL)” means the upper limit of payment for multiple source drugs for which a specific maximum allowable cost has been established by the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services pursuant to 42 CFR §447.514.</text> </paragraph> <paragraph num="(20)"> <text>“Freestanding clinics” means those clinics, not associated with a hospital, which are under the direction of physicians as further defined in COMAR 10.09.08.01.</text> </paragraph> <paragraph num="(21)"> <text>“Generic drug” means a drug that is:</text> <paragraph num="(a)"> <text>Available to pharmacy providers from at least one manufacturer;</text> </paragraph> <paragraph num="(b)"> <text>Rated as therapeutically equivalent by the U.S. Food and Drug Administration; and</text> </paragraph> <paragraph num="(c)"> <text>Not a brand name drug.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Innovator multiple source drug” means a multiple source drug that was originally marketed under an original new drug application approved by the U.S. Food and Drug Administration.</text> </paragraph> <paragraph num="(23)"> <text>“Institutional pharmacy” means a pharmacy owned and operated by a hospital, nursing facility, or clinic.</text> </paragraph> <paragraph num="(24)"> <text>“Invoice” means:</text> <paragraph num="(a)"> <text>A form issued or approved by the Department for use by providers in submitting bills for payment; or</text> </paragraph> <paragraph num="(b)"> <text>A bill issued by a manufacturer or wholesaler to a provider which indicates proof of purchase and the:</text> <paragraph num="(i)"> <text>Actual acquisition cost paid by the provider; or</text> </paragraph> <paragraph num="(ii)"> <text>The direct price charged to the provider by the manufacturer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Maintenance medication” means medication in chronic therapeutic categories corresponding to the following American Hospital Formulary Service (AHFS) classification numbers:</text> <paragraph num="(a)"> <text>Cardiac drugs (24:04);</text> </paragraph> <paragraph num="(b)"> <text>Antilipemic agents (24:06);</text> </paragraph> <paragraph num="(c)"> <text>Hypotensive agents (24:08);</text> </paragraph> <paragraph num="(d)"> <text>Vasodilating agents (24:12);</text> </paragraph> <paragraph num="(e)"> <text>Sclerosing agents (24:16);</text> </paragraph> <paragraph num="(f)"> <text>Alpha-adrenergic blocking agents (24:20);</text> </paragraph> <paragraph num="(g)"> <text>Beta-adrenergic blocking agents (24:24);</text> </paragraph> <paragraph num="(h)"> <text>Calcium-channel blocking agents (24:28);</text> </paragraph> <paragraph num="(i)"> <text>Renin-angiotensin-aldosterone system inhibitors (24:32);</text> </paragraph> <paragraph num="(j)"> <text>Hydantoins (28:12:12);</text> </paragraph> <paragraph num="(k)"> <text>Oxazolidinediones (28:12:16);</text> </paragraph> <paragraph num="(l)"> <text>Succinimides (28:12:20);</text> </paragraph> <paragraph num="(m)"> <text>Anticonvulsants, miscellaneous (28:12:92);</text> </paragraph> <paragraph num="(n)"> <text>Replacement solutions (40:12) (potassium supplements only);</text> </paragraph> <paragraph num="(o)"> <text>Diuretics (40:28);</text> </paragraph> <paragraph num="(p)"> <text>Lipotropic agents (56:24);</text> </paragraph> <paragraph num="(q)"> <text>Contraceptives (68:12);</text> </paragraph> <paragraph num="(r)"> <text>Estrogens and antiestrogens (68:16);</text> </paragraph> <paragraph num="(s)"> <text>Antidiabetic agents (68:20);</text> </paragraph> <paragraph num="(t)"> <text>Antihypoglycemic agents (68:22);</text> </paragraph> <paragraph num="(u)"> <text>Parathyroid (68:24);</text> </paragraph> <paragraph num="(v)"> <text>Progestins (68:32);</text> </paragraph> <paragraph num="(w)"> <text>Thyroid and antithyroid agents (68:36);</text> </paragraph> <paragraph num="(x)"> <text>Vitamins (88:00);</text> </paragraph> <paragraph num="(y)"> <text>Sodium fluoride (92:00); and</text> </paragraph> <paragraph num="(z)"> <text>Iron preparations, oral (20.04.04) (oral products in which ferrous sulfate is the only active ingredient and chewable tablets of any ferrous salt if combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation).</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(27)"> <text>“National average drug acquisition cost (NADAC)” means the average price paid by retail community pharmacies to acquire a prescription or over-the-counter covered out-patient drug as calculated by the Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(28)"> <text>“Nominal price” means a price that is less than 10 percent of the average manufacturer price (AMP) in the same quarter for which AMP is computed.</text> </paragraph> <paragraph num="(29)"> <text>“Nursing facility” means an institution as further defined in COMAR 10.09.10.01B(30), and classified as a long-term care facility.</text> </paragraph> <paragraph num="(30)"> <text>“Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(31)"> <text>“Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided.</text> </paragraph> <paragraph num="(32)"> <text>“Pharmacy” means an establishment or institution licensed in good standing that is required to obtain a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or a similar entity legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located.</text> </paragraph> <paragraph num="(33)"> <text>“Pharmacy and Therapeutics Committee” means a committee established by the Department to develop recommendations for pharmacy practices including but not limited to development of a preferred drug list according to Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(34)"> <text>“Preauthorization” means an approval required from the Department or its designee before a drug is dispensed.</text> </paragraph> <paragraph num="(35)"> <text>“Preferred drug list” means a list of recommended drugs developed by the Department that is based on the recommendations of the Pharmacy and Therapeutics Committee.</text> </paragraph> <paragraph num="(36)"> <text>“Prescriber” means a physician, dentist, podiatrist, or other professional licensed in good standing to prescribe legend drugs in the state in which the service is provided.</text> </paragraph> <paragraph num="(37)"> <text>“Prescription” means an order by a prescriber, or a prescriber’s order transferred from one pharmacist to another, for Program covered pharmacy services in accordance with applicable federal and State laws conveyed in one of the following forms:</text> <paragraph num="(a)"> <text>An original order signed by the prescriber and written on tamper-resistant paper which shall contain industry-recognized features designed to prevent:</text> <paragraph num="(i)"> <text>Unauthorized copying of a prescription form;</text> </paragraph> <paragraph num="(ii)"> <text>Erasure or modification of information written on the prescription by the prescriber; and</text> </paragraph> <paragraph num="(iii)"> <text>Use of counterfeit prescription forms;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A fax of an original order signed by the prescriber sent directly from the prescriber to the pharmacy provider;</text> </paragraph> <paragraph num="(c)"> <text>An electronic order; or</text> </paragraph> <paragraph num="(d)"> <text>An oral order from the prescriber to the pharmacist if the:</text> <paragraph num="(i)"> <text>Pharmacist promptly writes or prints out and files the prescription;</text> </paragraph> <paragraph num="(ii)"> <text>Prescription is not for a Schedule II controlled dangerous substance; and</text> </paragraph> <paragraph num="(iii)"> <text>Prescription is not for certain drugs that have been determined by the Secretary to present an emerging threat in the State because of increasing abuse and diversion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Professional dispensing fee” means the professional fee as defined in 42 CFR §447.502.</text> </paragraph> <paragraph num="(39)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(40)"> <text>“Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number.</text> </paragraph> <paragraph num="(41)"> <text>“Single source drug” means a covered drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application.</text> </paragraph> <paragraph num="(42)"> <text>“State actual acquisition cost (SAAC)” means, for those drugs or products identified by the Program, the Program’s or its designee’s calculation of AAC, based on a survey of providers’ actual prices paid to acquire drugs or products marketed or sold by specific manufacturers, when NADAC is unavailable.</text> </paragraph> <paragraph num="(43)"> <text>“State Formulary” means drug products listed in the United States Food and Drug Administration's Current List of Approved Drug Products with Therapeutic Equivalence Evaluations unless disqualified by the Department in conformity with Health Occupations Article, §12-504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(44)"> <text>“State-only participants” means those participants in the Program administered and financed by the State who do not meet the technical requirements of Title XIX of the Social Security Act and for whom the State does not claim federal financial participation.</text> </paragraph> <paragraph num="(45)"> <text>“Usual source of supply” means a wholesaler, distributor, or manufacturer from whom pharmacy providers within the State most frequently obtain their pharmaceuticals.</text> </paragraph> <paragraph num="(46)"> <text>“Wholesale acquisition cost (WAC)” means the price pharmaceutical manufacturers and distributors charge to wholesale distributors who provide retail and institutional pharmacies with products used to fill prescriptions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located.</text> </paragraph> <paragraph num="B."> <text>A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.</text> </paragraph> <paragraph num="C."> <text>A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery and to dispense drugs in the state in which the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Meet the licensure requirements in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Apply for participation in the Program using the application form designated by the Department;</text> </paragraph> <paragraph num="C."> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="D."> <text>Accept, as payment in full, the amounts paid by the Program plus any copayment required by Regulation .05C(5) of this chapter;</text> </paragraph> <paragraph num="E."> <text>Maintain adequate records and prescriptions for a minimum of 6 years, and make them available for inspection, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="F."> <text>Ensure that all prescriptions contain sufficient information to justify the invoice charges;</text> </paragraph> <paragraph num="G."> <text>Provide services without regard to race, creed, color, age, sex, national origin, marital status, physical or mental handicap;</text> </paragraph> <paragraph num="H."> <text>Agree that the provider may not employ knowingly a person who has been disqualified from the Program to compound or dispense Medical Assistance prescriptions, unless prior written approval has been received from the Department;</text> </paragraph> <paragraph num="I."> <text>Verify the participant’s eligibility before dispensing covered drugs;</text> </paragraph> <paragraph num="J."> <text>Place no restriction on the participant’s right to select providers of the participant’s choice;</text> </paragraph> <paragraph num="K."> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant;</text> </paragraph> <paragraph num="L."> <text>Maintain a record of the individual who picks up a prescription that includes:</text> <paragraph num="(1)"> <text>The prescription number;</text> </paragraph> <paragraph num="(2)"> <text>The name of the individual picking up the prescription;</text> </paragraph> <paragraph num="(3)"> <text>The signature of the individual picking up the prescription; and</text> </paragraph> <paragraph num="(4)"> <text>The date the prescription was picked up;</text> </paragraph> </paragraph> <paragraph num="M."> <text>Reverse invoice charges for any prescription not picked up by the participant or their designee within 14 days;</text> </paragraph> <paragraph num="N."> <text>Maintain a record of a participant or designee’s written authorization for automatic refill, if automatic refills are provided;</text> </paragraph> <paragraph num="O."> <text>Agree that the provider may not deny services to any participant because of the individual’s inability to pay the copayment;</text> </paragraph> <paragraph num="P."> <text>Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant;</text> </paragraph> <paragraph num="Q."> <text>On the Department’s request, provide within 15 days all invoices, as defined in Regulation .01B(24)(b) of this chapter, to assess the AAC; and</text> </paragraph> <paragraph num="R."> <text>Participate in the cost of dispensing survey and, on the Department’s request and within the Department’s timeline, provide to the Department all documentation that the Department or its designee determines is necessary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Department shall cover:</text> <paragraph num="(1)"> <text>Legend drugs except certain drugs for which federal financial participation is prohibited pursuant to 42 CFR §441.25;</text> </paragraph> <paragraph num="(2)"> <text>Schedule V cough preparations;</text> </paragraph> <paragraph num="(3)"> <text>Contraceptives;</text> </paragraph> <paragraph num="(4)"> <text>Hypodermic needles and syringes;</text> </paragraph> <paragraph num="(5)"> <text>Supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home;</text> </paragraph> <paragraph num="(6)"> <text>Enteric coated aspirin when prescribed for:</text> <paragraph num="(a)"> <text>The treatment of arthritic conditions as certified on the prescription in the prescriber's own handwriting or by the dispenser after consultation with the prescriber; and</text> </paragraph> <paragraph num="(b)"> <text>At least 250 tablets of 325 milligrams each, whether for initial prescriptions or refills.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Nonlegend ferrous sulfate oral preparations in the following strengths, dosage forms, and quantities only:</text> <paragraph num="(a)"> <text>Drops (125 milligrams per milliliter) in units of 50 milliliter dropper bottles;</text> </paragraph> <paragraph num="(b)"> <text>Elixir (220 milligrams per 5 milliliters) in quantities of at least 473 milliliters;</text> </paragraph> <paragraph num="(c)"> <text>Syrup (90 milligrams per 5 milliliters) in quantities of at least 473 milliliters; and</text> </paragraph> <paragraph num="(d)"> <text>Tablets (300 milligrams to 325 milligrams) in quantities of at least 100 tablets;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Nonlegend chewable tablets of any ferrous salt if:</text> <paragraph num="(a)"> <text>The tables are combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals;</text> </paragraph> <paragraph num="(b)"> <text>The participant is under 12 years old; and</text> </paragraph> <paragraph num="(c)"> <text>The quantity dispensed is at least 60 tablets and not more than a 100-day supply;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Nonlegend ergocalciferol liquid (8,000 international units per milliliter); and</text> </paragraph> <paragraph num="(10)"> <text>Any nonlegend drug determined by the Program to be cost effective.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prescription Requirement.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) of this regulation, a prescription is required for all items to be covered under this regulation even if the item is not a legend drug or otherwise does not require a prescription under federal or State pharmacy law.</text> </paragraph> <paragraph num="(2)"> <text>A prescription is not required for various forms of latex condoms or other drugs or products identified by the Program, each within the limits established by the Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may cover legend drugs not otherwise covered by §A of this regulation when:</text> <paragraph num="(1)"> <text>The drugs are identified as necessary to address a drug shortage as identified by the United States Food and Drug Administration; and</text> </paragraph> <paragraph num="(2)"> <text>The Department determines the coverage of the drugs medically necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered:</text> <paragraph num="(1)"> <text>Nonlegend drugs;</text> </paragraph> <paragraph num="(2)"> <text>Medical supplies and durable equipment;</text> </paragraph> <paragraph num="(3)"> <text>Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered;</text> </paragraph> <paragraph num="(4)"> <text>Drugs supplied to hospital inpatients;</text> </paragraph> <paragraph num="(5)"> <text>Drugs and supplies dispensed by the provider with an actual acquisition cost of $0;</text> </paragraph> <paragraph num="(6)"> <text>Experimental or investigational drugs;</text> </paragraph> <paragraph num="(7)"> <text>Except where authorized by the Department to be covered under this Regulation, injectables dispensed by a provider for administration by the prescriber;</text> </paragraph> <paragraph num="(8)"> <text>Food supplements or infant formulas, including supplemental vitamin and mineral products when administered orally;</text> </paragraph> <paragraph num="(9)"> <text>Sugar or salt substitutes;</text> </paragraph> <paragraph num="(10)"> <text>Cosmetics, medicine chest supplies, and sundries including all soaps, all body powders, all body oils or body lotions, cotton balls, adhesive strip bandages, cotton-tipped applicators, suntan products, deodorants, dentifrices, tissues, convenience packages of covered items, hot water bottles, ice caps, heating pads, soft cervical collars;</text> </paragraph> <paragraph num="(11)"> <text>Alcoholic beverages;</text> </paragraph> <paragraph num="(12)"> <text>Ostomy supplies;</text> </paragraph> <paragraph num="(13)"> <text>Those services authorized for payment to a prescriber, hospital, nursing facility, hospital outpatient department, or freestanding clinic;</text> </paragraph> <paragraph num="(14)"> <text>Oral drugs or injections for central nervous system stimulants, anorexigenics, and any other agents when used for weight control;</text> </paragraph> <paragraph num="(15)"> <text>Drug products for which federal financial participation is prohibited pursuant to 42 CFR §441.25;</text> </paragraph> <paragraph num="(16)"> <text>Ovulation stimulants unless used to treat an iatrogenic infertility;</text> </paragraph> <paragraph num="(17)"> <text>Effective January 1, 2006, any Part D drug for individuals who are eligible for Medicare Part D benefits;</text> </paragraph> <paragraph num="(18)"> <text>Drugs or products used for hair growth or other cosmetic purposes;</text> </paragraph> <paragraph num="(19)"> <text>Any drug or supply that is covered and reimbursed by the Department under any other chapter of this subtitle; and</text> </paragraph> <paragraph num="(20)"> <text>Any drug or product the Department determines is not medically necessary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prescriptions requiring preauthorization according to Regulation .06 of this chapter are not covered unless the required preauthorization has been obtained from the Department or its designee.</text> </paragraph> <paragraph num="C."> <text>Limitations on Covered Services.</text> <paragraph num="(1)"> <text>The allowable cost of ingredients dispensed pursuant to a prescription may not exceed an upper limit as established in Regulation .07, of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Refills.</text> <paragraph num="(a)"> <text>The prescriber shall authorize refills only on the original prescription if the prescriber determines a refill is necessary and appropriate.</text> </paragraph> <paragraph num="(b)"> <text>The Program may authorize no more than 11 refills, not to exceed other applicable federal and State limitations.</text> </paragraph> <paragraph num="(c)"> <text>The pharmacy may not automatically refill a prescription unless authorized in writing by the recipient or their designee.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Days Supply.</text> <paragraph num="(a)"> <text>The total amount dispensed under one prescription order, including refills, is limited to a 360 days supply, not to exceed other applicable federal and State limitations.</text> </paragraph> <paragraph num="(b)"> <text>Unless otherwise specified, prescriptions shall be limited to a 34 day supply at one time.</text> </paragraph> <paragraph num="(c)"> <text>Unless otherwise specified, maintenance medication shall be limited to:</text> <paragraph num="(i)"> <text>A 34-day supply for the initial prescription; and</text> </paragraph> <paragraph num="(ii)"> <text>Up to a 100-day supply at one time for all subsequent prescriptions.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Prescriptions shall be dispensed at the lower of the quantity prescribed or the maximum days supply allowed at one time unless:</text> <paragraph num="(i)"> <text>The Program authorizes a reduction of the quantity; or</text> </paragraph> <paragraph num="(ii)"> <text>The prescription is the final refill for the balance remaining on the total prescription order.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Providers may partially fill a prescription for Schedule II controlled dangerous substances, but the remaining portion of the prescription may not be later filled.</text> </paragraph> <paragraph num="(f)"> <text>Oral sodium fluoride products used in the prevention of dental caries are limited to an original prescription of up to a 120-day supply with up to two refills, not to exceed a total of a 360-day supply.</text> </paragraph> <paragraph num="(g)"> <text>Prescriptions for drugs packaged by the manufacturer as an unbreakable unit may be dispensed in increments of appropriate package size.</text> </paragraph> <paragraph num="(h)"> <text>Whether for an initial or subsequent prescription, contraceptive prescriptions may be dispensed in up to a 12 months supply at one time.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Generic Drugs.</text> <paragraph num="(a)"> <text>Except as limited by §C(4)(b) and (c) of this regulation, when a drug product is prescribed by its nonproprietary or generic name, a provider shall substitute as follows:</text> <paragraph num="(i)"> <text>A drug product in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, therapeutically equivalent to the drug as prescribed; or</text> </paragraph> <paragraph num="(ii)"> <text>A drug product with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, bioequivalent to the drug as prescribed as rated by the U.S. Food and Drug Administration.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A provider may not substitute a generic drug for a brand name drug under §C(4)(a) of this regulation if:</text> <paragraph num="(i)"> <text>The prescriber specifically directs otherwise; and</text> </paragraph> <paragraph num="(ii)"> <text>The prescriber requests and received approval from the Program.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Department shall only authorize a provider to substitute a drug product under this regulation when there will be a savings in or no increase in cost to the Department.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Copayment for Services Rendered on or after July 1, 2005.</text> <paragraph num="(a)"> <text>There will be no pharmacy copayment for prescriptions for the following:</text> <paragraph num="(i)"> <text>Individuals younger than 21 years old;</text> </paragraph> <paragraph num="(ii)"> <text>Pregnant women;</text> </paragraph> <paragraph num="(iii)"> <text>Institutionalized individuals who are inpatients in long-term care facilities or other institutions requiring spending all but a minimal amount of income for medical costs;</text> </paragraph> <paragraph num="(iv)"> <text>Family planning drugs and devices; and</text> </paragraph> <paragraph num="(v)"> <text>Individuals who are American Indians or Alaskan Natives.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The copayments for prescriptions not excluded from a copayment under §C(5)(a) of this regulation are:</text> <paragraph num="(i)"> <text>$3 for prescriptions for brand name drugs not on the preferred drug list;</text> </paragraph> <paragraph num="(ii)"> <text>$1 for prescriptions for generic drugs and brand name drugs on the preferred drug list; and</text> </paragraph> <paragraph num="(iii)"> <text>$1 for prescriptions for antiretroviral drugs in American Hospital Formulary Service therapeutic class 8:18:08.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Reimbursement may not be made:</text> <paragraph num="(a)"> <text>For nonlegend enteric coated aspirin tablets in strengths other than 300 to 325 milligrams;</text> </paragraph> <paragraph num="(b)"> <text>For any other nonlegend aspirin products such as sustained release capsules, buffered tablets, compressed tablets, liquid preparations or combination products in which aspirin is only one of the active ingredients;</text> </paragraph> <paragraph num="(c)"> <text>For nonlegend ferrous sulfate products in strengths or dosage forms not listed in Regulation .04A(8) of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>For nonlegend iron products combined with other active ingredients, except for chewable tablets as described in Regulation .04A(9) of this chapter; or</text> </paragraph> <paragraph num="(e)"> <text>At a reimbursement level which exceeds the maximum allowable cost established by the Program.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Condoms dispensed by pharmacy providers are subject to the following limitations:</text> <paragraph num="(a)"> <text>The recipient shall present a Medical Assistance card with a current eligibility period;</text> </paragraph> <paragraph num="(b)"> <text>Only 12 condoms may be dispensed to an individual at one time;</text> </paragraph> <paragraph num="(c)"> <text>The provider may dispense condoms only to the individual named on the Medical Assistance card;</text> </paragraph> <paragraph num="(d)"> <text>Natural membrane condoms are not covered; and</text> </paragraph> <paragraph num="(e)"> <text>Both the recipient receiving the condoms and the provider shall sign the dispensing documentation.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A compounded prescription for intravenous therapy is subject to the following limitations:</text> <paragraph num="(a)"> <text>The Program may not cover a compounded prescription for intravenous therapy if a premixed, therapeutically equivalent commercial intravenous therapy is available from a commercial source;</text> </paragraph> <paragraph num="(b)"> <text>The Program may not cover the diluent component of a compounded prescription for intravenous therapy; and</text> </paragraph> <paragraph num="(c)"> <text>All claims submitted require new prescription numbers.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Prescriptions dispensed to participants residing in nursing facilities are subject to the following limitations:</text> <paragraph num="(a)"> <text>Claims shall be identified as nursing facilities prescriptions by coding mechanisms determined by the Program;</text> </paragraph> <paragraph num="(b)"> <text>Credits for unused unit dose medication and any other medication which may legally be returned to pharmacy stock:</text> <paragraph num="(i)"> <text>Shall be made within 60 days of Program payment;</text> </paragraph> <paragraph num="(ii)"> <text>May not take into account any professional fee paid by the Program; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall adjust for leave of absence prescriptions; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Multiple prescriptions dispensed to a recipient residing in a nursing facility for the same drug product or compounded prescription shall receive only one professional fee per calendar month except for:</text> <paragraph num="(i)"> <text>Leave of absence prescriptions;</text> </paragraph> <paragraph num="(ii)"> <text>Prescriptions for intravenous therapy; and</text> </paragraph> <paragraph num="(iii)"> <text>Prescriptions for Schedule II-V controlled substances.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Tamper Resistant Prescriptions.</text> <paragraph num="(1)"> <text>Prescriptions written on or after April 1, 2008, that do not contain at least one of the tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered.</text> </paragraph> <paragraph num="(2)"> <text>Prescriptions written on or after October 1, 2008, that do not contain all three tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered.</text> </paragraph> </paragraph> <paragraph num="E."> <text>No covered drug or supply identified under Regulation .04 of this chapter shall be reimbursed under Regulation .07 of this chapter if:</text> <paragraph num="(1)"> <text>Federal financial participation from the Centers for Medicare & Medicaid Services is not available for the drug or supply; or</text> </paragraph> <paragraph num="(2)"> <text>Prior authorization for the drug or supply is required under Regulation .06 of this chapter but was not obtained.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Expanded Limitations."> <paragraph num="A."> <text>A drug is not covered for State-only participants if:</text> <paragraph num="(1)"> <text>The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c));</text> </paragraph> <paragraph num="(2)"> <text>The Program has provided notice to the manufacturer of the manufacturer's failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>The manufacturer has failed to demonstrate to the Secretary that the drug’s availability is essential to State-Only participants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The provider shall obtain preauthorization from the Department or its designee for any prescription for:</text> <paragraph num="(1)"> <text>Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply;</text> </paragraph> <paragraph num="(2)"> <text>Nonmaintenance drugs for more than a 34 day supply;</text> </paragraph> <paragraph num="(3)"> <text>A usual and customary charge exceeding $2,500;</text> </paragraph> <paragraph num="(4)"> <text>Female hormones for biologic males when used for treating sexual aggression;</text> </paragraph> <paragraph num="(5)"> <text>Vitamin and mineral products when given by nasogastric, jejunostomy, or gastrostomy tube in the home;</text> </paragraph> <paragraph num="(6)"> <text>Drugs rejected by the point-of-sale system because of edits established by the Program to ensure appropriate utilization of medication before the prescription is dispensed, if the Department does not allow provider level overrides;</text> </paragraph> <paragraph num="(7)"> <text>Where a prescriber has filed an official report of an adverse event or product problem with the Program or the United States Food and Drug Administration regarding a generic drug, the brand name drug used as an alternative to that generic drug;</text> </paragraph> <paragraph num="(8)"> <text>Drugs identified by the Program that are subject to fraud or abuse; or</text> </paragraph> <paragraph num="(9)"> <text>Drugs not on the preferred drug list developed under Regulation .12 of this chapter except for:</text> <paragraph num="(a)"> <text>Antiretrovirals; or</text> </paragraph> <paragraph num="(b)"> <text>Any other drugs or classes of drugs as determined by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Off-Label Uses of Drugs.</text> <paragraph num="(1)"> <text>The Department may require preauthorization for an off-label use of a drug.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B(3) of this regulation, the Department or its designee may not grant preauthorization for an off-label use of the drug if:</text> <paragraph num="(a)"> <text>The off-label use is inconsistent with generally accepted standards of care;</text> </paragraph> <paragraph num="(b)"> <text>The drug is prescribed for a non-medically accepted indication;</text> </paragraph> <paragraph num="(c)"> <text>The drug is prescribed in a manner not approved by the U.S. Food and Drug Administration; or</text> </paragraph> <paragraph num="(d)"> <text>The off-label use is not documented in and supported by the latest edition of:</text> <paragraph num="(i)"> <text>The American Hospital Formulary Service Drug Information (AHFS-DI);</text> </paragraph> <paragraph num="(ii)"> <text>The Thompson Micromedex Drugdex; or</text> </paragraph> <paragraph num="(iii)"> <text>The United States Pharmacopeia.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department or its designee may grant preauthorization for the off-label use of mental health drugs for individuals 18 years old and younger within the limits established by the Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Preauthorization is not required for:</text> <paragraph num="(1)"> <text>Prescriptions for oral contraceptive drug products;</text> </paragraph> <paragraph num="(2)"> <text>Drugs dispensed in unit dose form to patients in a nursing facility by a provider using an approved unit dose system.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Preauthorization Process.</text> <paragraph num="(1)"> <text>The provider or the prescriber, if appropriate, ordering a drug subject to preauthorization, shall:</text> <paragraph num="(a)"> <text>Contact the Department or its designee through an established 24-hour hot-line to request preauthorization; and</text> </paragraph> <paragraph num="(b)"> <text>Provide required information and documentation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department or its designee shall respond to a request for preauthorization by telephone or facsimile request within 24 hours of receipt of a request for preauthorization.</text> </paragraph> <paragraph num="(3)"> <text>A 72-hour supply of the prescribed drug shall be allowed:</text> <paragraph num="(a)"> <text>In an emergency as determined by the prescriber;</text> </paragraph> <paragraph num="(b)"> <text>In an emergency as determined by the pharmacist, if possible in consultation with the prescriber; or</text> </paragraph> <paragraph num="(c)"> <text>If the Department does not provide a response to a preauthorization request within 24 hours.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A preauthorization granted by the Department or its designee under this Regulation may not be used by any person as indicating that the individual for whom the prescription was ordered is eligible for Program benefits on the day the prescription is filled or that the Department will guarantee reimbursement for the prescription. All Program restrictions and requirements on eligibility, covered services, and limitations on reimbursement remain in effect.</text> </paragraph> <paragraph num="(5)"> <text>A 30-day emergency supply of atypical antipsychotic drugs not on the preferred drug list shall be:</text> <paragraph num="(a)"> <text>Immediately authorized by the Department or its designee in an emergency as determined by the:</text> <paragraph num="(i)"> <text>Prescriber; or</text> </paragraph> <paragraph num="(ii)"> <text>Pharmacist, if unable to contact the prescriber; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Limited to a one-time 30-day period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reconsideration of Adverse Decisions.</text> <paragraph num="(1)"> <text>The Department or its designee shall respond within 48 hours of receiving all necessary documentation of a written request from a participant or provider for reconsideration of an adverse decision on a preauthorization request.</text> </paragraph> <paragraph num="(2)"> <text>The Department or its designee shall ensure that all adverse decisions of reconsiderations are reviewed and issued by a physician.</text> </paragraph> <paragraph num="(3)"> <text>Appeals of adverse decisions of reconsideration requests shall be filed in accordance with Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department or its designee may:</text> <paragraph num="(1)"> <text>Require preauthorization for more than ten prescriptions including refills per 30-day period per noninstitutionalized participant; and</text> </paragraph> <paragraph num="(2)"> <text>May exclude certain drugs such as antibiotics from the limit as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall produce records to verify any charge to the Program upon request.</text> </paragraph> <paragraph num="B."> <text>The provider shall bill all appropriate insurance carriers before requesting payment from the Department.</text> </paragraph> <paragraph num="C."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="D."> <text>The provider shall submit a request for payment on a form designated by the Department.</text> </paragraph> <paragraph num="E."> <text>The Department may return to the provider all invoices not properly completed.</text> </paragraph> <paragraph num="F."> <text>The pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for similar prescriptions.</text> </paragraph> <paragraph num="G."> <text>The physician or osteopath shall charge the Program his actual acquisition cost for the drugs dispensed.</text> </paragraph> <paragraph num="H."> <text>Determination of Allowable Cost.</text> <paragraph num="(1)"> <text>For covered legend drugs and nonlegend drugs, allowable cost shall be:</text> <paragraph num="(a)"> <text>The NADAC; or</text> </paragraph> <paragraph num="(b)"> <text>When the NADAC is unavailable, the lowest of the:</text> <paragraph num="(i)"> <text>WAC plus 0 percent;</text> </paragraph> <paragraph num="(ii)"> <text>FUL; and</text> </paragraph> <paragraph num="(iii)"> <text>SAAC.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For covered legend brand name drugs for which the prescriber files an official report of an adverse event or product problem regarding a generic drug with the Program or the United States Food and Drug Administration, or when the Department requires the brand name drugs to be dispensed, the allowable cost shall be:</text> <paragraph num="(a)"> <text>The NADAC of the branded product; or</text> </paragraph> <paragraph num="(b)"> <text>When the NADAC of the branded product is unavailable, the lower of the:</text> <paragraph num="(i)"> <text>WAC plus 0 percent; or</text> </paragraph> <paragraph num="(ii)"> <text>SAAC.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For condoms dispensed by pharmacy providers, the allowable cost shall be as described in §H(1) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>For covered over-the-counter products, and covered medical supplies, the allowable cost shall be as described in §H(1) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>For covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail, the allowable cost shall be:</text> <paragraph num="(a)"> <text>The NADAC; or</text> </paragraph> <paragraph num="(b)"> <text>When the NADAC is unavailable, the lowest of the:</text> <paragraph num="(i)"> <text>WAC plus 0 percent;</text> </paragraph> <paragraph num="(ii)"> <text>FUL; or</text> </paragraph> <paragraph num="(iii)"> <text>SAAC.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except when purchased at the 340B price by a provider, the allowable cost for covered clotting factors shall be the lower of the:</text> <paragraph num="(a)"> <text>WAC plus 0 percent; or</text> </paragraph> <paragraph num="(b)"> <text>AAC plus 8 percent.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>For 340B covered entities or FQHCs that fill Program participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act, the allowable cost shall be the provider’s AAC.</text> </paragraph> <paragraph num="(8)"> <text>For facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS, the allowable cost shall be the provider’s AAC.</text> </paragraph> <paragraph num="(9)"> <text>For facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, the allowable cost shall be the provider’s AAC.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Payment for Covered Services to a Pharmacy.</text> <paragraph num="(1)"> <text>Payment for covered legend and nonlegend drugs, over-the-counter products, and covered medical supplies is the lower of:</text> <paragraph num="(a)"> <text>The provider's charge according to §F of this regulation, less any applicable co-payment according to Regulation .05C(5) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The amount that is:</text> <paragraph num="(i)"> <text>The allowable cost of the item in §H(1) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Payment for covered legend brand name drugs as indicated in §H(2) of this regulation shall be the lower of:</text> <paragraph num="(a)"> <text>The provider’s charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The total of:</text> <paragraph num="(i)"> <text>The allowable cost of the item in §H(2) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Payment for condoms will be the lower of the:</text> <paragraph num="(a)"> <text>The provider's charge according to §F of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Allowable cost according to §H(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Copayment is not required for condom orders.</text> </paragraph> <paragraph num="(5)"> <text>Payment for covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail shall be the lower of the:</text> <paragraph num="(a)"> <text>Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The total of:</text> <paragraph num="(i)"> <text>The allowable cost of the item in §H(5) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Payment for clotting factor shall be lower of the:</text> <paragraph num="(a)"> <text>Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Amount that is:</text> <paragraph num="(i)"> <text>The allowable cost of the item in §H(6) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Payment for providers that fill Medicaid participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act shall be the total of:</text> <paragraph num="(a)"> <text>The allowable cost of the item in §H(7) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Plus the applicable professional dispensing fee indicated in §I(12) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Payment for facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS shall be the total of:</text> <paragraph num="(a)"> <text>The allowable cost of item in §H(8) this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Payment for facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, shall be the total of:</text> <paragraph num="(a)"> <text>The allowable cost of item in §H(9) this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for participants residing in nursing facilities shall be $11.67.</text> </paragraph> <paragraph num="(11)"> <text>The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for individuals other than residents in nursing facilities shall be $10.67.</text> </paragraph> <paragraph num="(12)"> <text>The professional dispensing fee for covered services rendered on or after April 1, 2017 to a pharmacy for medication purchased at the prices authorized under Section 340B of the Public Health Services Act shall be $12.12.</text> </paragraph> <paragraph num="(13)"> <text>The Department may pay a pharmacy using an approved unit dose system on the basis of a monthly dispensing fee per nursing home resident. The value of the fee may not be higher than the pharmacy’s usual and customary charge to non-Medicaid patients for similar services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Payment for Covered Services to a Physician or Osteopath.</text> <paragraph num="(1)"> <text>Except as provided in §J(2) of this regulation, the Program shall reimburse a physician or osteopath for covered drugs dispensed at the lower of:</text> <paragraph num="(a)"> <text>The physician's or osteopath's actual acquisition cost, less any applicable copayment according to Regulation .05C(5) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The allowable cost of the item in §H of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Program shall reimburse a physician or osteopath for covered drugs dispensed to Medicaid participants on the same basis as reimbursement to a registered pharmacist if:</text> <paragraph num="(a)"> <text>The physician or osteopath dispenses the covered drugs on a regular basis in the physician's or osteopath’s office;</text> </paragraph> <paragraph num="(b)"> <text>The physician's or osteopath’s office is not located within a 10-mile radius of a Medicaid participating pharmacy; and</text> </paragraph> <paragraph num="(c)"> <text>The Program, after consultation with the Board of Pharmacy, has verified that the physician or osteopath is dispensing drugs in accordance with accepted pharmacy standards.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>In order to determine whether the current professional dispensing fee is appropriate, the Department will periodically conduct surveys to determine the actual costs involved in filling a prescription in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or third-party source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, pharmacist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department may consult with the State Pharmaceutical Association, the State Board of Pharmacy, and the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The findings and recommendations of these groups will be given consideration.</text> </paragraph> <paragraph num="D."> <text>The Department will give the provider reasonable notice of its intentions to impose sanctions. In the written notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="E."> <text>Any provider voluntarily withdrawing from the Program or removed or suspended from the Program according to this section shall notify recipients that he no longer honors Medical Assistance cards before rendering additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Preferred Drug Program."> <paragraph num="A."> <text>The Department may establish a Pharmacy and Therapeutics Committee (Committee).</text> </paragraph> <paragraph num="B."> <text>The Committee shall consist of the following 12 members:</text> <paragraph num="(1)"> <text>Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs;</text> </paragraph> <paragraph num="(2)"> <text>Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and</text> </paragraph> <paragraph num="(3)"> <text>Two members of the Committee shall be consumer representatives residing in the State.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Consideration for membership on the Committee shall be given to appointing physicians and pharmacists participating in the Program or with experience in developing or practicing under a preferred drug list.</text> </paragraph> <paragraph num="D."> <text>The Committee members shall:</text> <paragraph num="(1)"> <text>Be appointed by the Secretary;</text> </paragraph> <paragraph num="(2)"> <text>Have 3 year terms;</text> </paragraph> <paragraph num="(3)"> <text>Be allowed to serve more than one term; and</text> </paragraph> <paragraph num="(4)"> <text>Elect a chairman and vice chairman.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Meet at least twice a year;</text> </paragraph> <paragraph num="(2)"> <text>To the extent feasible, review all drug classes included on the list at least once every 12 months;</text> </paragraph> <paragraph num="(3)"> <text>Develop recommendations for a preferred drug list for the Program by considering the:</text> <paragraph num="(a)"> <text>Clinical efficacy of the drug;</text> </paragraph> <paragraph num="(b)"> <text>Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and</text> </paragraph> <paragraph num="(c)"> <text>Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Recommend:</text> <paragraph num="(a)"> <text>The addition or deletion of existing drugs as necessary;</text> </paragraph> <paragraph num="(b)"> <text>Preauthorization criteria; and</text> </paragraph> <paragraph num="(c)"> <text>Conditions or illnesses to be exempted from prior authorization based on clinical data; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Inform the Committee of any decisions regarding the preferred drug list;</text> </paragraph> <paragraph num="(2)"> <text>Annually publish the preferred drug list;</text> </paragraph> <paragraph num="(3)"> <text>Maintain an updated preferred drug list that is available electronically;</text> </paragraph> <paragraph num="(4)"> <text>Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee;</text> </paragraph> <paragraph num="(5)"> <text>Provide an expedited review process for newly approved drugs designated as priority by the FDA; and</text> </paragraph> <paragraph num="(6)"> <text>Provide manufacturers and the public an opportunity to submit written material to the committee.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee:</text> <paragraph num="(1)"> <text>May not include certain therapeutic classes including antiretroviral medications used to treat the AIDS virus, which are exempt from preauthorization as indicated in Regulation .06A(12) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall, for therapeutic classes other than those described in §G(1) of this regulation, include at least one drug approved by the FDA for use in the specific therapeutic class, in every therapeutic class for which the FDA has approved three or fewer drugs for use; and</text> </paragraph> <paragraph num="(3)"> <text>Shall, in every therapeutic class other than those described in §G(1) of this regulation, offer a choice of at least two pharmaceutical or biological entities without an administrative preference for each therapeutic class in which there are four or more pharmaceutical or biological entities approved by the FDA.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department may negotiate and collect supplemental rebates from manufacturers.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-103.1, 15-105, 15-118, and 15-148, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 16, 1966</annotation> <annotation type="History" subtype="Administrative History">Amended effective March 15, 1967; July 1, 1967; December 1, 1969; July 1, 1971; January 22, 1975 (2:2 Md. R. 86); March 18, 1975 (2:9 Md. R. 659); July 1, 1975 (2:15 Md. R. 1066); January 1, 1976 (2:29 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Existing regulations repealed and new regulations adopted effective September 1, 1976 (3:18 Md. R. 981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 1, 1985 (12:10 Md. R. 961); April 30, 1988 (15:8 Md. R. 1009); March 14, 1989 (16:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .04, .05A, .06, .07H, and .09A—C amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1203); expired November 10, 1979</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03, .05 and .07 amended as an emergency provision effective November 15, 1988 (15:23 Md. R. 2654); emergency status expired March 13, 1989</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .05C, .07H, H-1 amended as an emergency provision effective October 1, 1982 (10:1 Md. R. 19); adopted permanently effective January 30, 1983 (10:1 Md. R. 29)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .07 amended as an emergency provision effective December 31, 1987 (15:2 Md. R. 117) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 and .07 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 23, 1995 (22:21 Md. R. 1615)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .05, and .07 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective December 30, 1996 (23:26 Md. R. 1860)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .05C, and .07C, H—J amended as an emergency provision effective April 1, 1991 (18:8 Md. R. 861); amended permanently effective July 8, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 1992 (19:11 Md. R. 1015)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .05C, and .07I amended as an emergency provision effective July 9, 1998 (25:16 Md. R. 1261); amended permanently effective October 19, 1998 (25:21 Md. R. 1574)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired effective January 1, 2004</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 16, 2004 (31:3 Md. R. 207); November 23, 2006 (33:23 Md. R. 1794); April 21, 2008 (35:8 Md. R. 805); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896); December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01C, N, S; .07F, H; and .09A—C amended effective November 11, 1979 (6:22 Md. R. 1779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E-1—E-3 adopted effective December 26, 1980 (7:26 Md. R. 2422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01H-1 amended effective May 5, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01P amended effective February 8, 1980 (7:3 Md. R. 263)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02B; .04F (recodified from §H); .05B; .07F-1, H-1 (recodified from §§G and J, respectively) adopted effective November 11, 1979 (6:22 Md. R. 1779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 14, 1989 (16:4 Md. R. 497); November 28, 2011 (38:24 Md., R. 1502); March 31, 2014 (41:6 Md. R. 378); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 1, 1979 (6:7 Md. R. 576); February 8, 1980 (7:3 Md. R. 263); July 11, 1988 (15:14 Md. R. 1654); November 28, 2011 (38:24 Md., R. 1502); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 17, 1980 (7:21 Md. R. 1994); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637); July 1, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 3, 2003 (30:4 Md. R. 316); February 16, 2004 (31:3 Md. R. 207); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective October 29, 1984 (11:21 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G adopted effective March 9, 1987 (14:5 Md. R. 579)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective May 1, 1979 (6:7 Md. R. 576); November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); October 17, 1980 (7:21 Md. R. 1994); October 29, 1984 (11:21 Md. R. 1811); March 9, 1987 (14:5 Md. R. 579); July 11, 1988 (15:14 Md. R. 1654); July 1, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 16, 2004 (31:3 Md. R. 207); March 13, 2006 (33:5 Md. R. 520); June 14, 2021 (48:12 Md. R. 470); March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, C amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective July 1, 1992 (19:12 Md. R. 1134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective December 26, 1980 (7:26 Md. R. 2422); March 9, 1987 (14:5 Md. R. 579); September 7, 1987 (14:18 Md. R. 1966); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:24 Md. R. 2769); March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); amended permanently effective November 10, 2003 (30:22 Md. R. 1579)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective September 27, 2004 (31:19 Md. R. 1432); August 1, 2005 (32:15 Md. R. 1320); December 6, 2007 (34:24 Md. R. 2157); March 31, 2014 (41:6 Md. R. 378)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D and E adopted as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F and G adopted effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective December 1, 1992 (19:23 Md. R. 2040)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 amended effective November 28, 2011 (38:24 Md., R. 1502)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1A amended effective March 3, 2003 (30:4 Md. R. 316); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); November 8, 1981 (8:21 Md. R. 1707); August 30, 1982 (9:17 Md. R. 1708); December 19, 1983 (10:25 Md. R. 2268); October 29, 1984 (11:21 Md. R. 1811); September 7, 1987 (14:18 Md. R. 1966); December 12, 1988 (15:24 Md. R. 2769)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 1, 1992 (19:12 Md. R. 1134); October 10, 2016 (43:20 Md. R. 1109); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective December 6, 2007 (34:24 Md. R. 2157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective June 1, 1985 (12:10 Md. R. 961); May 5, 1986 (13:9 Md. R. 1029); May 4, 1987 (14:9 Md. R. 1080); October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009); July 11, 1988 (15:14 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective July 1, 1977 (4:14 Md. R. 1080); emergency status extended at 4:23 Md. R. 1728; adopted permanently effective November 4, 1977 (4:23 Md. R. 1734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective July 1, 1978 (5:12 Md. R. 967); May 1, 1979 (6:7 Md. R. 576); July 1, 1980 (7:13 Md. R. 1278); March 9, 1987 (14:5 Md. R. 579); July 1, 1987 (14:13 Md. R. 1473); July 11, 1988 (15:14 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1204); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1122); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective July 1, 1984 (11:14 Md. R. 1246); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H-1 amended effective March 9, 1987 (14:5 Md. R. 579)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H, I amended effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended effective March 19, 1990 (17:5 Md. R. 637)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); amended permanently effective October 15, 1991 (18:19 Md. R 2099)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended effective March 3, 2003 (30:4 Md. R. 316); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J adopted as an emergency provision effective July 1, 1980 (7:13 Md. R. 1266); adopted permanently effective October 17, 1980 (7:21 Md. R. 1995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective September 18, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12E amended effective November 23, 2006 (33:23 Md. R. 1794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12G amended effective December 6, 2007 (34:24 Md. R. 2157)</annotation> <annotation type="History" subtype="Administrative History">Table I adopted effective June 1, 1985 (12:10 Md. R. 961)</annotation> <annotation type="History" subtype="Administrative History">Table I repealed and new Table I adopted effective May 5, 1986 (13:9 Md. R. 1029); amended effective October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009)</annotation> </annotations> </chapter> <chapter num="04" heading="Home Health Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means functions normally associated with mobility, eating, elimination, body hygiene and dressing.</text> </paragraph> <paragraph num="(2)"> <text>“Attending” means the role of an individual who establishes the plan of treatment and certifies the necessity for home health services for a participant following a hospitalization.</text> </paragraph> <paragraph num="(3)"> <text>“Case coordinator” means a licensed health professional designated by a home health agency to coordinate the care of a participant.</text> </paragraph> <paragraph num="(4)"> <text>“Certified nurse midwife (CNM)” means an individual who meets licensure requirements and conditions for participation as a certified nurse midwife set forth in COMAR 10.09.01.</text> </paragraph> <paragraph num="(5)"> <text>“Certified nurse practitioner” means an individual who meets the licensing requirements and conditions for participation as a nurse practitioner set forth in COMAR 10.09.01.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq.</text> </paragraph> <paragraph num="(7)"> <text>“Electronic Visit Verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2.</text> </paragraph> <paragraph num="(8)"> <text>“Face-to-face” means contact with a participant that occurs in person or via audio-visual telehealth in accordance with COMAR 10.09.49.</text> </paragraph> <paragraph num="(9)"> <text>“Health team” means the physician or nonphysician practitioner and the home health agency personnel who render services listed in Regulation .04B of this chapter to a participant.</text> </paragraph> <paragraph num="(10)"> <text>“Home” means the place of residence occupied by the participant, including a domiciliary level facility, but other than a hospital, nursing facility, or other medical institution.</text> </paragraph> <paragraph num="(11)"> <text>“Home health agency” means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare.</text> </paragraph> <paragraph num="(12)"> <text>“Home health aide” means a person who meets the requirements of COMAR 10.07.10, and has received instruction from, and renders services under the supervision of, a registered nurse.</text> </paragraph> <paragraph num="(13)"> <text>“In person” means contact with a participant that occurs in the physical presence of the participant and the provider.</text> </paragraph> <paragraph num="(14)"> <text>“Intermittent” means services which are furnished on a medically predictable recurring basis.</text> </paragraph> <paragraph num="(15)"> <text>“Licensed nurse” means a person who is licensed as a registered nurse or as a licensed practical nurse in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(16)"> <text>“Medicaid average rate” means the average projected per diem rate established for the Department's fiscal year as specified in COMAR 10.09.10.07B(2) multiplied by 30.</text> </paragraph> <paragraph num="(17)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Medical supplies” means items which are generally recognized under accepted standards of medical practice as serving a therapeutic or diagnostic purpose and are medically necessary to enable home health agency personnel to carry out effectively the care the physician has ordered for the treatment or diagnosis of the patient's illness or injury, and which are accounted for in billing records.</text> </paragraph> <paragraph num="(19)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq.</text> </paragraph> <paragraph num="(20)"> <text>“Newborn early discharge assessment” means a visit to the newborn infant and postpartum mother to observe and assess the health status of both the newborn and the mother.</text> </paragraph> <paragraph num="(21)"> <text>“Nonphysician practitioner” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed as a certified nurse practitioner, clinical nurse specialist, a certified nurse-midwife, or a physician assistant in the jurisdiction in which the service is provided; and</text> </paragraph> <paragraph num="(b)"> <text>Works in collaboration with or under the supervision of the ordering practitioner.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Occupational therapist” means a person who is licensed or registered as an occupational therapist in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(23)"> <text>“Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(24)"> <text>“Part-time” means services, usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of an illness or injury.</text> </paragraph> <paragraph num="(25)"> <text>“Physical therapist” means a person who is licensed or registered as a physical therapist in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(26)"> <text>“Physician” means an individual who meets the licensure requirements and conditions for participation set forth in COMAR 10.09.02.</text> </paragraph> <paragraph num="(27)"> <text>“Physician assistant” means an individual who meets license requirements and conditions for participation set forth in COMAR 10.09.55.</text> </paragraph> <paragraph num="(28)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(29)"> <text>“Progress note” means a dated, written notation by a member of the health team which summarizes facts about the care given and the patient's response during a given period of time, specifically addresses the established goals of treatment, is consistent with the patient plan of care, is written immediately following each visit, and is part of the provider's permanent record for the participant.</text> </paragraph> <paragraph num="(30)"> <text>“Provider” means a person or an organization who meets the requirements of Regulations .03 and .04 of this chapter and who, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(31)"> <text>“Speech-language pathologist” means a person who is licensed as a speech-language pathologist in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(32)"> <text>“Supervision” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic evaluation of the act of accomplishing the function or activity.</text> </paragraph> <paragraph num="(33)"> <text>“Support system” means a family member, friend, neighbor, or any person who renders services, which would otherwise be covered under Regulation .04 of this chapter, to the participant.</text> </paragraph> <paragraph num="(34)"> <text>“Telehealth” has the meaning stated in COMAR 10.09.49.02.</text> </paragraph> <paragraph num="(35)"> <text>“Visit” means the time spent rendering a covered service to a participant at home by an individual employed by a home health agency.</text> </paragraph> <paragraph num="(36)"> <text>“Witness” means a person who on behalf of the participant is able to personally verify at the time of service that the participant received home health care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>A home health agency shall be licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland, or shall be part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland, or shall be legally authorized to provide home health services in the jurisdiction in which the service is provided.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>To be a provider, a home health agency shall be a participating home health agency under Medicare.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program, the home health agency shall:</text> <paragraph num="(1)"> <text>Apply for participation in the Program using the form designated by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Have in effect a provider agreement with the Department;</text> </paragraph> <paragraph num="(4)"> <text>Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services;</text> </paragraph> <paragraph num="(5)"> <text>Provide verification to the Department, in the manner prescribed by the Department, of all changes in the provider's charges within 10 days of the occurrence of the changes;</text> </paragraph> <paragraph num="(6)"> <text>Maintain all patient care, medical supply, timesheets, official agency recipient or witness signature records, and billing records for a minimum of 6 years after completion of an audit by the Department and make them available, upon request, to the appropriate State and federal personnel or their designees during office hours;</text> </paragraph> <paragraph num="(7)"> <text>Secure from the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner a written plan of treatment which relates the items and services to the participant's medical condition;</text> </paragraph> <paragraph num="(8)"> <text>Maintain a participant's plan of care based on the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment for the participant;</text> </paragraph> <paragraph num="(9)"> <text>Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap;</text> </paragraph> <paragraph num="(10)"> <text>Verify the participant's eligibility;</text> </paragraph> <paragraph num="(11)"> <text>Place no restriction on a participant's right to select his choice of providers under this subtitle;</text> </paragraph> <paragraph num="(12)"> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant;</text> </paragraph> <paragraph num="(13)"> <text>Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant;</text> </paragraph> <paragraph num="(14)"> <text>Provide services in person unless expressly authorized by the Department to render services via telehealth; and</text> </paragraph> <paragraph num="(15)"> <text>If not rendering services in person, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Plan of Treatment.</text> <paragraph num="(1)"> <text>The plan of treatment under §B(8) shall include:</text> <paragraph num="(a)"> <text>Prognosis;</text> </paragraph> <paragraph num="(b)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(c)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(d)"> <text>Frequency of visits for each type of service ordered;</text> </paragraph> <paragraph num="(e)"> <text>Duration of treatment of each type of service ordered;</text> </paragraph> <paragraph num="(f)"> <text>Rehabilitation potential;</text> </paragraph> <paragraph num="(g)"> <text>Functional limitations;</text> </paragraph> <paragraph num="(h)"> <text>Permitted and prohibited activities;</text> </paragraph> <paragraph num="(i)"> <text>Diet;</text> </paragraph> <paragraph num="(j)"> <text>Medications;</text> </paragraph> <paragraph num="(k)"> <text>Treatments;</text> </paragraph> <paragraph num="(l)"> <text>Mental status;</text> </paragraph> <paragraph num="(m)"> <text>Medical supplies;</text> </paragraph> <paragraph num="(n)"> <text>Durable medical equipment;</text> </paragraph> <paragraph num="(o)"> <text>Safety measures to protect against injury; and</text> </paragraph> <paragraph num="(p)"> <text>Other appropriate items.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The plan of treatment shall be reviewed, updated, and signed at least every 60 days by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner, in consultation with the registered nurse or the case coordinator.</text> </paragraph> <paragraph num="(3)"> <text>The physician, physician assistant, certified nurse midwife, or certified nurse practitioner shall:</text> <paragraph num="(a)"> <text>Sign and date the initial plan of treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Document that the physician or nonphysician practitioner, who is not employed by the home health agency, has had a face-to-face encounter with the participant no more than 90 days before the home health start of care date or within 30 days of the start of the home health care, including the date of the encounter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For participants admitted immediately to home health upon discharge from a hospital or post-acute setting, the attending acute or post-acute physician shall document the clinical findings of the face-to-face encounter.</text> </paragraph> <paragraph num="(5)"> <text>The plan of treatment shall be part of the provider's permanent record for the participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Plan of Care.</text> <paragraph num="(1)"> <text>For each type of service ordered, the plan of care under §C(9) shall, at a minimum, include:</text> <paragraph num="(a)"> <text>Goals of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Actions or procedures needed to meet the goals;</text> </paragraph> <paragraph num="(c)"> <text>Dates the goals are expected to be achieved;</text> </paragraph> <paragraph num="(d)"> <text>Problems encountered, if any;</text> </paragraph> <paragraph num="(e)"> <text>Revision of goals and actions or procedures, whenever necessary; and</text> </paragraph> <paragraph num="(f)"> <text>Appropriate discharge activities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The plan of care shall be reviewed, dated, and signed at least every 60 days by the registered nurse or the case coordinator upon consultation with the appropriate health team.</text> </paragraph> <paragraph num="(3)"> <text>The plan of care is a part of the provider's permanent record for the participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in §§B and C of this regulation when the services are:</text> <paragraph num="(1)"> <text>Provided upon the written order of a physician, physician assistant, certified nurse midwife, or certified nurse practitioner;</text> </paragraph> <paragraph num="(2)"> <text>Furnished under the current plan of treatment;</text> </paragraph> <paragraph num="(3)"> <text>Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service;</text> </paragraph> <paragraph num="(4)"> <text>Consistent with the current diagnosis and treatment of the participant's condition;</text> </paragraph> <paragraph num="(5)"> <text>In accordance with accepted standards of medical practice;</text> </paragraph> <paragraph num="(6)"> <text>Required by the medical condition rather than the convenience or preference of the participant;</text> </paragraph> <paragraph num="(7)"> <text>Considered under accepted standards of medical practice to be a specific and effective treatment for the participant's condition;</text> </paragraph> <paragraph num="(8)"> <text>Required on a part-time, intermittent basis;</text> </paragraph> <paragraph num="(9)"> <text>Rendered in the participant's home, or other setting when normal life activities take the participant outside the home, by an approved provider;</text> </paragraph> <paragraph num="(10)"> <text>Received by the participant as documented by the participant's signature or the signature of the participant's witness on the home health agency's official forms; and</text> </paragraph> <paragraph num="(11)"> <text>Adequately described in the signed and dated progress notes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers the following services:</text> <paragraph num="(1)"> <text>Skilled nursing services provided by a licensed nurse when the complexity of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed nurse;</text> </paragraph> <paragraph num="(2)"> <text>Home health aide services provided by a home health aide, that include:</text> <paragraph num="(a)"> <text>Assistance with activities of daily living as defined in Regulation .01B of this chapter when performed in addition to other home health services;</text> </paragraph> <paragraph num="(b)"> <text>Other health care services properly delegated by the registered nurse pursuant to the Maryland Nurse Practice Act as set forth in Health Occupations Article, Title 8, Annotated Code of Maryland, that may include, but are not limited to:</text> <paragraph num="(i)"> <text>Noninvasive parts of ostomy or catheter care;</text> </paragraph> <paragraph num="(ii)"> <text>Nonsterile dressing changes;</text> </paragraph> <paragraph num="(iii)"> <text>Procedures;</text> </paragraph> <paragraph num="(iv)"> <text>Exercises;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Reporting of the participant's condition and needs; and</text> </paragraph> <paragraph num="(d)"> <text>Completion of appropriate records;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physical therapy services, provided by a physical therapist:</text> <paragraph num="(a)"> <text>When the condition of a participant requires the judgment, knowledge, and skills of a licensed or registered physical therapist;</text> </paragraph> <paragraph num="(b)"> <text>When the services are directly related to the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment, which specifies:</text> <paragraph num="(i)"> <text>Body part or parts to be treated;</text> </paragraph> <paragraph num="(ii)"> <text>Type of modalities or treatments to be rendered;</text> </paragraph> <paragraph num="(iii)"> <text>Expected results of physical therapy treatments;</text> </paragraph> <paragraph num="(iv)"> <text>Frequency and duration of treatment;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>When the services are of a diagnostic, rehabilitative, or therapeutic nature and:</text> <paragraph num="(i)"> <text>Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in physical functioning in a reasonable and generally predictable period of time; or</text> </paragraph> <paragraph num="(ii)"> <text>Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Occupational therapy services, provided by an occupational therapist:</text> <paragraph num="(a)"> <text>When the condition of the participant requires the judgment, knowledge, and skills of a licensed occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>When the services are provided with the expectation that there will be a significant practical improvement in a participant's level of physical functioning within a reasonable period of time; and</text> </paragraph> <paragraph num="(c)"> <text>When the services fall within one or more of the following categories:</text> <paragraph num="(i)"> <text>Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests;</text> </paragraph> <paragraph num="(ii)"> <text>Selection and teaching of task-oriented therapeutic activities designed to restore physical function;</text> </paragraph> <paragraph num="(iii)"> <text>Teaching of compensatory techniques to improve the level of independence in the activities of daily living;</text> </paragraph> <paragraph num="(iv)"> <text>Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance;</text> </paragraph> <paragraph num="(v)"> <text>Improvement of mobility skills; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Speech-language pathology services performed by a licensed speech-language pathologist when the:</text> <paragraph num="(a)"> <text>Services are of a diagnostic, rehabilitative, or therapeutic nature and:</text> <paragraph num="(i)"> <text>Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in a reasonable and generally predictable period of time; or</text> </paragraph> <paragraph num="(ii)"> <text>Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The condition of a recipient requires the judgment, knowledge, and skills of a speech-language pathologist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Program covers a provider's newborn early discharge assessment visit to a participant when the assessment:</text> <paragraph num="(1)"> <text>Is 4 hours or less;</text> </paragraph> <paragraph num="(2)"> <text>Is ordered by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner;</text> </paragraph> <paragraph num="(3)"> <text>Is delivered to a participant and a participant's mother who have been discharged within 48 hours after delivery;</text> </paragraph> <paragraph num="(4)"> <text>Occurs within 36 hours after discharge;</text> </paragraph> <paragraph num="(5)"> <text>Includes:</text> <paragraph num="(a)"> <text>An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant;</text> </paragraph> <paragraph num="(b)"> <text>An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse physical symptoms of the mother;</text> </paragraph> <paragraph num="(c)"> <text>Collection of a blood specimen for newborn screening as described in COMAR 10.52.12;</text> </paragraph> <paragraph num="(d)"> <text>An evaluation of risk factors that identify biological factors for the infant, maternal health behaviors, psychosocial environmental problems, or any other concerns or problems perceived by the nurse that are identified on a form specified by the Department; and</text> </paragraph> <paragraph num="(e)"> <text>Referrals for any continuing health care services, including skilled nursing services under COMAR 10.09.53 or home health services under this chapter; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is conducted by a registered nurse.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A provider may deliver services in §B of this regulation via telehealth if:</text> <paragraph num="(1)"> <text>The Department expressly authorizes the provider to render services via telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>The patient's plan of care specifies that the service may be delivered via telehealth.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Nonskilled services rendered by licensed nurses, physical therapists, occupational therapists and speech pathologists;</text> </paragraph> <paragraph num="B."> <text>Services and medical supplies that are not medically necessary and appropriate;</text> </paragraph> <paragraph num="C."> <text>Durable medical equipment except as covered under COMAR 10.09.12;</text> </paragraph> <paragraph num="D."> <text>Services primarily for the purpose of housekeeping, including but not limited to:</text> <paragraph num="(1)"> <text>Cleaning of floor and furniture;</text> </paragraph> <paragraph num="(2)"> <text>Laundry; and</text> </paragraph> <paragraph num="(3)"> <text>Shopping;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Home health aide services unless biweekly supervisory visits by a registered nurse in the participant’s home are made, every second visit of which shall include observations of the delivery of services by the aide to the participant;</text> </paragraph> <paragraph num="F."> <text>Home health aide services rendered to participants with chronic conditions when those participants require only assistance with activities of daily living as defined in Regulation .01B of this chapter unless preauthorized as specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="G."> <text>Meals;</text> </paragraph> <paragraph num="H."> <text>More than one visit per type of service per day, unless preauthorized as specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="I."> <text>Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which payments by the Program to the provider exceed the Medicaid average nursing facility rate unless preauthorized as specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="J."> <text>Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day unless preauthorized as specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="K."> <text>Services for investigational and experimental purposes;</text> </paragraph> <paragraph num="L."> <text>Services specified in Regulation .04 of this chapter to persons eligible for Medicare coverage of those services;</text> </paragraph> <paragraph num="M."> <text>A service not documented as received by the participant as indicated by the participant’s signature or the signature of a witness on the home health agency's official form;</text> </paragraph> <paragraph num="N."> <text>Supervisory visits by a registered nurse to monitor services of a home health aide;</text> </paragraph> <paragraph num="O."> <text>Initial assessments by a therapist or a registered nurse;</text> </paragraph> <paragraph num="P."> <text>Services provided for the convenience or preference of the participant or primary caregiver rather than as required by the participant’s medical condition;</text> </paragraph> <paragraph num="Q."> <text>Services specified in Regulation .04 of this chapter which duplicate or supplant services performed by the participant and those services rendered by the participant’s family;</text> </paragraph> <paragraph num="R."> <text>Services which are covered by other insurance or entitlement programs;</text> </paragraph> <paragraph num="S."> <text>Newborn early discharge services provided more than one time to a participant;</text> </paragraph> <paragraph num="T."> <text>A newborn early discharge visit provided on the same day as another skilled nursing visit billed under this chapter; and</text> </paragraph> <paragraph num="U."> <text>Home health services ordered by an:</text> <paragraph num="(1)"> <text>Individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>Entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>Preauthorization is required for:</text> <paragraph num="(1)"> <text>More than one visit per type of service per day;</text> </paragraph> <paragraph num="(2)"> <text>Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which the provider anticipates payments from the program in excess of the Medicaid average nursing facility rate;</text> </paragraph> <paragraph num="(3)"> <text>Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day; and</text> </paragraph> <paragraph num="(4)"> <text>Any instances in which home health aide services without skilled nursing services are provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preauthorization may be:</text> <paragraph num="(1)"> <text>Issued by telephone when the provider submits to the Department or its designee adequate documentation demonstrating that the service or services are medically necessary.</text> </paragraph> <paragraph num="(2)"> <text>Denied when the Department, after taking into consideration the particular circumstances of the participant, determines the payments to the provider for any service or combination of services rendered during any 30-day period would exceed the cost to the program of any alternative services which could be used for the same purpose.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit his request for payment on the form designated by the Department.</text> </paragraph> <paragraph num="B."> <text>To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the Electronic Visit Verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2.</text> </paragraph> <paragraph num="C."> <text>The provider shall submit requests for payment for supplies on the same invoice which requests payment for the visit during which the supplies were used.</text> </paragraph> <paragraph num="D."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> <paragraph num="E."> <text>Payment Rates.</text> <paragraph num="(1)"> <text>The provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate in accordance with the Department's fee schedule.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For out-of-State providers, rates shall be paid at the lower of the following:</text> <paragraph num="(a)"> <text>The home state's Medicaid rate for the same service rendered by the same provider if the provider participates in its home state Medicaid Program; or</text> </paragraph> <paragraph num="(b)"> <text>The rate paid for the same service rendered by a provider in the nearest Maryland county.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall pay home health providers for medical and other supplies which are used during a covered home health visit as part of the treatment ordered by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner at a rate that is the lesser of the:</text> <paragraph num="(a)"> <text>Provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>Medicaid rate for the supply or pharmaceutical under COMAR 10.09.12 and 10.09.03.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Subject to the limitations of the State budget, the fee schedule rates shall be adjusted annually by the same factor used by the Centers for Medicare and Medicaid Services in updating Medicare's prospective payment system rates. The annual fee schedule rate adjustment shall be limited to a maximum of 5 percent and be effective the date on which Medicare's rate changes are implemented.</text> </paragraph> <paragraph num="(5)"> <text>The fee schedule effective January 1, 2025 is as follows:</text> </paragraph> </paragraph> <paragraph num="F."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="G."> <text>The Department shall reimburse for supervision of home health aide services by a registered nurse as part of the home health aide reimbursement.</text> </paragraph> <paragraph num="H."> <text>Payment to a provider of newborn early discharge services may not exceed the rate for one skilled nursing visit.</text> </paragraph> <paragraph num="I."> <text>The Department shall reimburse for preauthorized home health services upon verification that a face-to-face encounter with the participant was performed as described under Regulation .03C of this chapter.</text> </paragraph> <paragraph num="J."> <text>The home health provider shall identify the individual who ordered the home health services by recording the individual practitioner's National Provider Identifier (NPI) number on the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement regulations are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Rule."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1985 (12:11 Md. R. 1048)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .05L amended, and .05M adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F, I amended effective November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F, J amended effective April 4, 1988 (15:7 Md. R. 849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 4, 1988 (15:7 Md. R. 849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective November 12, 1990 (17:22 Md. R. 2656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective October 1, 2000 (28:1 Md. R. 21); emergency status extended at 28:7 Md. R. 687 and 28:22 Md. R. 1931 (see 28:24 Md. R. 2125); emergency status expired October 28, 2001</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 12, 2007 (34:5 Md. R. 560)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C repealed effective September 26, 2016 (43:19 Md. R. 1072)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 27, 2010 (37:26 Md. R. 1787); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05W amended effective March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, H amended effective June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective June 14, 2010 (37:12 Md. R. 800); May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H adopted effective September 30, 2013 (40:19 Md. R. 1544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> </annotations> </chapter> <chapter num="05" heading="Dental Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adverse action” means any action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service.</text> </paragraph> <paragraph num="(2)"> <text>“Aftercare” means the period of follow-up care after initial services are rendered, during which any additional related services rendered by the same provider are included in the payment for the original services.</text> </paragraph> <paragraph num="(3)"> <text>“Ambulatory surgical center (ASC)” means any Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization.</text> </paragraph> <paragraph num="(4)"> <text>“Appeal” means the process:</text> <paragraph num="(a)"> <text>To resolve a participant's dispute with any adverse action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service; and</text> </paragraph> <paragraph num="(b)"> <text>Governed by:</text> <paragraph num="(i)"> <text>COMAR 10.01.04; and</text> </paragraph> <paragraph num="(ii)"> <text>Any and all applicable court orders.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Benefits” means a schedule of dental services to be administered by the DBA to Medical Assistance participants pursuant to this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Brick and mortar dental office” means the fixed and permanent location where the mobile dental unit:</text> <paragraph num="(a)"> <text>Is linked through either ownership or a legally binding contract; and</text> </paragraph> <paragraph num="(b)"> <text>Transmits participant records.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Claim” means an itemized statement requesting payment for services rendered by health care providers, such as dentists, billed:</text> <paragraph num="(a)"> <text>Electronically;</text> </paragraph> <paragraph num="(b)"> <text>Through a web-based portal; or</text> </paragraph> <paragraph num="(c)"> <text>Manually on the American Dental Association (ADA) claim form.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Consultation” means written opinion or advice rendered by a dentist, upon request by the patient's attending physician or dentist, for the further evaluation or management of the patient by the attending physician or dentist. If the consultant dentist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant is not a consultation.</text> </paragraph> <paragraph num="(9)"> <text>“Dental Administrative Services Organization (DASO)” means an entity with which the Department contracts to administer dental benefits by performing some or all of the following functions:</text> <paragraph num="(a)"> <text>General administration;</text> </paragraph> <paragraph num="(b)"> <text>Regulatory compliance;</text> </paragraph> <paragraph num="(c)"> <text>Network administration;</text> </paragraph> <paragraph num="(d)"> <text>Member services;</text> </paragraph> <paragraph num="(e)"> <text>Claims administration;</text> </paragraph> <paragraph num="(f)"> <text>Data reporting and analysis;</text> </paragraph> <paragraph num="(g)"> <text>Medical management; or</text> </paragraph> <paragraph num="(h)"> <text>Quality monitoring.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession.</text> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq., or the Department's designee.</text> </paragraph> <paragraph num="(12)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 U.S.C. §1396d(e) as amended by OBRA 1989.</text> </paragraph> <paragraph num="(13)"> <text>“Emergency services” means services necessary for the treatment of any condition requiring immediate attention for the relief of pain, hemorrhage, acute infection, or traumatic injury to the teeth, supporting structures (that is, periodontal membranes, gums, and alveolar bone), the jaws, and tissues of the oral cavity.</text> </paragraph> <paragraph num="(14)"> <text>“EPSDT certified provider” means a physician, physician assistant, or nurse practitioner certified by the Department to provide EPSDT services.</text> </paragraph> <paragraph num="(15)"> <text>“Free-standing clinic” means a health care facility approved for participation in the Maryland Medical Assistance Program that is not licensed as a hospital or as part of a hospital or nursing home and that is not administratively part of a health maintenance organization or physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of the clinic administrator (as defined in 42 CFR §405.1801) or a health officer and which is organized and operated to provide clinic services.</text> </paragraph> <paragraph num="(16)"> <text>“General supervision” has the meaning stated in COMAR 10.44.21 and 10.44.27.</text> </paragraph> <paragraph num="(17)"> <text>“Hospital” has the meaning stated in Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Maryland Healthy Smiles Dental Program” means the Maryland Medicaid dental program.</text> </paragraph> <paragraph num="(19)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(20)"> <text>“Medically necessary” means that a service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice, dental practice, or both;</text> </paragraph> <paragraph num="(c)"> <text>The most cost effective service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Medicare” means the insurance program administered by the Federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq.</text> </paragraph> <paragraph num="(22)"> <text>“Mobile dental unit” means any self-contained facility in which dentistry will be provided and which may be moved, towed, or transported from one location to another to provide clinically necessary and appropriate dental care in the unit.</text> </paragraph> <paragraph num="(23)"> <text>“Mobile dental practice” means any practice which provides the necessary and clinically appropriate dental equipment to be delivered to a community based location where dental services will be provided on site.</text> </paragraph> <paragraph num="(24)"> <text>“Network provider” means a health care entity or health care professional that has executed a provider agreement with Maryland Medicaid.</text> </paragraph> <paragraph num="(25)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(26)"> <text>“Preauthorization” means an approval required from the Department or its designee before the provision of dental or oral health care services.</text> </paragraph> <paragraph num="(27)"> <text>“Primary dental office” means the fixed and permanent location where the mobile dental unit:</text> <paragraph num="(a)"> <text>Is linked through either ownership or a legally binding contract; and</text> </paragraph> <paragraph num="(b)"> <text>Transmits participant records.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(29)"> <text>“Provider” means:</text> <paragraph num="(a)"> <text>An individual dentist, duly licensed to provide services for participants, or an association, partnership, or an incorporated or unincorporated group of dentists so licensed, that, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; or</text> </paragraph> <paragraph num="(b)"> <text>An approved dental school whose students are permitted under Health Occupations Article, §4-301(b)(1), Annotated Code of Maryland, to treat dental patients and which, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Referral” means a transfer of the patient from a physician or dentist to a dentist for diagnosis and treatment of the condition for which the referral was made. The dentist to whom the referral is made will no longer be considered the consultant.</text> </paragraph> <paragraph num="(31)"> <text>“REM” means the fee-for-service managed care program for individuals who have certain rare and expensive health care conditions set forth in COMAR 10.09.69.</text> </paragraph> <paragraph num="(32)"> <text>“Self-ligating braces” means braces which utilize a permanently installed, moveable component to secure the archwire without the use of ligatures.</text> </paragraph> <paragraph num="(33)"> <text>“Traditional comprehensive orthodontic treatment” means a coordinated diagnosis and treatment to improve craniofacial dysfunction or dentofacial deformity which may utilize fixed and removable orthodontic appliances and focus on specific objectives at various stages of dentofacial development.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A dentist shall be licensed and legally authorized to practice dentistry in the state in which service is provided.</text> </paragraph> <paragraph num="C."> <text>All dentists and dental hygienists working for a mobile dental unit or mobile dental practice shall be currently licensed and registered with the Maryland Board of Dental Examiners.</text> </paragraph> <paragraph num="D."> <text>The driver of the mobile dental unit:</text> <paragraph num="(1)"> <text>Shall possess a valid operator’s license appropriate for the type of vehicle that is driven;</text> </paragraph> <paragraph num="(2)"> <text>May not have violations related to the operation of a motor vehicle in the last 3 years; and</text> </paragraph> <paragraph num="(3)"> <text>May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An EPSDT certified provider shall be:</text> <paragraph num="(1)"> <text>A doctor of medicine licensed and legally authorized to practice in the state in which the service is provided;</text> </paragraph> <paragraph num="(2)"> <text>A nurse practitioner who is licensed and certified to practice in the state in which services are provided;</text> </paragraph> <paragraph num="(3)"> <text>A physician assistant who is licensed to practice in the state in which services are provided; or</text> </paragraph> <paragraph num="(4)"> <text>A local health department, or a federally qualified health center, which has on its staff, and under whose supervision EPSDT services are delivered:</text> <paragraph num="(a)"> <text>A doctor of medicine licensed in the state in which the service is provided;</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner licensed and certified in the state in which services are provided; or</text> </paragraph> <paragraph num="(c)"> <text>A physician assistant licensed in the state in which services are provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established in COMAR 26.12.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="G."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services rendered, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Provider Qualifications and Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Comply with requirements set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate in the Program as a dental provider, a provider shall meet the licensure requirements established in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="C."> <text>To participate in the Program as an EPSDT certified provider of fluoride varnish services, the provider shall:</text> <paragraph num="(1)"> <text>Have MDH Certification for the Application of Fluoride Varnish; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the following requirements:</text> <paragraph num="(a)"> <text>Be board-certified in one of the following:</text> <paragraph num="(i)"> <text>Pediatrics;</text> </paragraph> <paragraph num="(ii)"> <text>Family practice; or</text> </paragraph> <paragraph num="(iii)"> <text>Internal medicine;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Be a licensed physician, physician assistant, or licensed and certified nurse practitioner, delivering primary health care to children and adolescents; or</text> </paragraph> <paragraph num="(c)"> <text>Be a local health department or a federally qualified health center.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Complete the Dental Provider Application; and</text> </paragraph> <paragraph num="(2)"> <text>Submit verification of the National Provider Identifier (NPI) Number.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mobile Dental Unit and Mobile Dental Practice.</text> <paragraph num="(1)"> <text>The mobile dental unit shall provide or arrange for comprehensive dental services with a participating Maryland Healthy Smiles Dental Program provider.</text> </paragraph> <paragraph num="(2)"> <text>The mobile dental unit and mobile dental practice shall be linked through either ownership or a legally binding contract to a brick and mortar dental office that has a permanent and fixed location.</text> </paragraph> <paragraph num="(3)"> <text>The brick and mortar dental office shall participate in the Maryland Healthy Smiles Dental Program.</text> </paragraph> <paragraph num="(4)"> <text>The mobile dental unit and mobile dental practice shall have and utilize the electronic technology that enables the same day exchange of patient records with:</text> <paragraph num="(a)"> <text>The brick and mortar dental office; and</text> </paragraph> <paragraph num="(b)"> <text>If requested, the dental office of the parent or legal guardian's choice.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The mobile dental unit and mobile dental practice service area shall be limited to 30 miles in a rural setting and 10 miles in an urban setting from the brick and mortar dental office that the mobile dental unit and mobile dental practice is either owned by or with which the dental office holds a legally binding contract.</text> </paragraph> <paragraph num="(6)"> <text>A mobile dental unit and mobile dental practice shall:</text> <paragraph num="(a)"> <text>Maintain dental records for the patient;</text> </paragraph> <paragraph num="(b)"> <text>Observe all patient rights;</text> </paragraph> <paragraph num="(c)"> <text>Obtain written, informed consent from a parent or legal guardian, which shall:</text> <paragraph num="(i)"> <text>Be renewed each school year before treating a minor; and</text> </paragraph> <paragraph num="(ii)"> <text>Allow the parent or legal guardian to request that the dental records be sent to a provider of their choice;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating:</text> <paragraph num="(i)"> <text>Equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Flammability;</text> </paragraph> <paragraph num="(iii)"> <text>Construction;</text> </paragraph> <paragraph num="(iv)"> <text>Infection control;</text> </paragraph> <paragraph num="(v)"> <text>Sanitation procedures; and</text> </paragraph> <paragraph num="(vi)"> <text>Zoning;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Comply with the statutes and regulations of the Maryland Department of the Environment for all dental radiographic and imaging equipment;</text> </paragraph> <paragraph num="(f)"> <text>Obtain, keep current, and make readily available all applicable county and city licenses or permits necessary to operate the mobile dental unit or mobile dental practice which would include the active dentist, hygienist and dental assistant licenses and the dental radiographic and imaging equipment permits;</text> </paragraph> <paragraph num="(g)"> <text>Provide an update to the Department regarding any mobile dental unit or mobile dental practice provider changes within 72 hours;</text> </paragraph> <paragraph num="(h)"> <text>Provide access to a ramp or a lift if services are provided to disabled individuals;</text> </paragraph> <paragraph num="(i)"> <text>Have ready access to a properly functioning sterilization system;</text> </paragraph> <paragraph num="(j)"> <text>Have ready access to an adequate supply of potable water, including hot water;</text> </paragraph> <paragraph num="(k)"> <text>Have immediate access to toilet facilities;</text> </paragraph> <paragraph num="(l)"> <text>Have an appropriately covered noncorrosive metal container for refuse and waste materials;</text> </paragraph> <paragraph num="(m)"> <text>Have carbon monoxide and smoke detection devices or systems installed and in proper working condition;</text> </paragraph> <paragraph num="(n)"> <text>Have a chair designed and purposed exclusively for the provision of dental services;</text> </paragraph> <paragraph num="(o)"> <text>Have a dental treatment light;</text> </paragraph> <paragraph num="(p)"> <text>Have a radiograph unit with appropriate processing equipment;</text> </paragraph> <paragraph num="(q)"> <text>Have an evacuation unit suitable for dental surgical use;</text> </paragraph> <paragraph num="(r)"> <text>Have written procedures for medical emergencies;</text> </paragraph> <paragraph num="(s)"> <text>Have appropriate equipment to treat medical emergencies;</text> </paragraph> <paragraph num="(t)"> <text>Have appropriate and sufficient dental instruments and infection control supplies; and</text> </paragraph> <paragraph num="(u)"> <text>Have any other equipment or system that is necessary to provide the services being rendered by the mobile dental unit or mobile dental practice.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Dental hygienists or dental assistants may not solely operate a mobile dental unit or mobile dental practice.</text> </paragraph> <paragraph num="(8)"> <text>The owner or owners of a mobile dental unit or mobile dental practice shall submit a business plan to the dental administrative service organization for the mobile unit or mobile dental practice that includes:</text> <paragraph num="(a)"> <text>The mission of the mobile dental unit and mobile dental practice;</text> </paragraph> <paragraph num="(b)"> <text>Verification of ownership of the mobile dental unit and mobile dental practice;</text> </paragraph> <paragraph num="(c)"> <text>A list of the clinical practitioners that will render services in the mobile dental unit or mobile dental practice; and</text> </paragraph> <paragraph num="(d)"> <text>The targeted population.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers medically necessary dental services for participants younger than 21 years old and eligible former foster care participants younger than 26 years old, including but not limited to the following:</text> <paragraph num="(1)"> <text>Emergency, preventive, diagnostic, and treatment services;</text> </paragraph> <paragraph num="(2)"> <text>Semiannual cleaning, fluoride treatment and examination;</text> </paragraph> <paragraph num="(3)"> <text>Pit and fissure sealants for the occlusal surfaces of posterior permanent teeth that are without decay;</text> </paragraph> <paragraph num="(4)"> <text>Orthodontic care for conditions which:</text> <paragraph num="(a)"> <text>Have adjusted case scores of at least 15 points on the Handicapping Labio-Lingual Deviations Index (HLD) Table No. 4; and</text> </paragraph> <paragraph num="(b)"> <text>Cause dysfunction due to a handicapping malocclusion that is supported by comprehensive pretreatment orthodontic records, which include at a minimum:</text> <paragraph num="(i)"> <text>Cephalometric head film with analysis;</text> </paragraph> <paragraph num="(ii)"> <text>Panoramic or full series periapical radiographs;</text> </paragraph> <paragraph num="(iii)"> <text>Extra-oral and intra-oral photographs;</text> </paragraph> <paragraph num="(iv)"> <text>Clinical summary with diagnosis;</text> </paragraph> <paragraph num="(v)"> <text>HLD score sheets from attending orthodontist; and</text> </paragraph> <paragraph num="(vi)"> <text>Treatment plan;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Consultations for participants who meet the requirements of §A(1), (2), (3), or (4) of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Drugs dispensed or injectable drugs administered by the dentist within the limitations of COMAR 10.09.03;</text> </paragraph> <paragraph num="(7)"> <text>Oral Health assessment by an EPSDT certified provider, and if determined medically necessary, the application of fluoride varnish for children 9 months old through 5 years old;</text> </paragraph> <paragraph num="(8)"> <text>General anesthesia during dental procedures, when it is medically necessary; and</text> </paragraph> <paragraph num="(9)"> <text>Fluoride varnish.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers the following medically necessary dental services for participants 21 years old or older:</text> <paragraph num="(1)"> <text>Periodic, limited, and comprehensive oral examinations;</text> </paragraph> <paragraph num="(2)"> <text>X-rays, including:</text> <paragraph num="(a)"> <text>First and each additional intraoral periapical film;</text> </paragraph> <paragraph num="(b)"> <text>Single, two, three, or four film bitewings, which are limited to:</text> <paragraph num="(i)"> <text>Two per patient per year for REM participants 21 years old or older; or</text> </paragraph> <paragraph num="(ii)"> <text>One per patient per year for pregnant participants 21 years old or older; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>One panoramic radiographic image every 36 months;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prophylaxis for adults, which is limited to:</text> <paragraph num="(a)"> <text>One per patient per 3 months for REM participants 21 years old or older; or</text> </paragraph> <paragraph num="(b)"> <text>Two per patient per 12 months for adults ages 21 and over;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Topical application of fluoride, which is limited to:</text> <paragraph num="(a)"> <text>One application per patient per 6 months for REM participants 21 years old or older; or</text> </paragraph> <paragraph num="(b)"> <text>One application per patient per year for pregnant and postpartum participants 21 years old or older;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Amalgam restorations for permanent teeth for one, two, three, four, or more surfaces, which are limited to one identical restoration per tooth per 24 months;</text> </paragraph> <paragraph num="(6)"> <text>Resin restorations for anterior permanent teeth for one, two, three, four, or more surfaces or involving incisal angle, which are limited to one identical restoration per tooth per 24 months;</text> </paragraph> <paragraph num="(7)"> <text>Other restorative services including:</text> <paragraph num="(a)"> <text>Recementing of crowns, which is limited to two times for the same crown;</text> </paragraph> <paragraph num="(b)"> <text>Prefabricated stainless steel crown for permanent teeth;</text> </paragraph> <paragraph num="(c)"> <text>Fillings — sedative, interim or temporary filling; and</text> </paragraph> <paragraph num="(d)"> <text>Pin retention — per tooth, in addition to restoration;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Pulp capping, direct and indirect, excluding final restoration;</text> </paragraph> <paragraph num="(9)"> <text>Gingovectomy or gingivoplasty — per quadrant, which is limited to two quadrants per year per patient;</text> </paragraph> <paragraph num="(10)"> <text>Periodontal scaling and root planning — per quadrant;</text> </paragraph> <paragraph num="(11)"> <text>Full mouth debridement, which is limited to one per patient per 2 years, and may not be completed on the same day as prophylaxis;</text> </paragraph> <paragraph num="(12)"> <text>Periodontal maintenance — following active periodontal therapy, which is limited to two per patient per year;</text> </paragraph> <paragraph num="(13)"> <text>Adjustment of complete maxillary and mandibular denture;</text> </paragraph> <paragraph num="(14)"> <text>Adjustment of partial maxillary and mandibular denture;</text> </paragraph> <paragraph num="(15)"> <text>Recementing of bridge, which is limited to two times for the same bridge;</text> </paragraph> <paragraph num="(16)"> <text>Extractions of:</text> <paragraph num="(a)"> <text>Coronal remnants for deciduous teeth; and</text> </paragraph> <paragraph num="(b)"> <text>Erupted tooth or exposed root;</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Biopsy of oral tissue, hard or soft;</text> </paragraph> <paragraph num="(18)"> <text>Alveoplasty, in conjunction or not in conjunction with extractions — per quadrant;</text> </paragraph> <paragraph num="(19)"> <text>Incision and drainage of abscess intraoral; and</text> </paragraph> <paragraph num="(20)"> <text>Palliative emergency treatment of dental pain that is not associated with recently rendered service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall reimburse for covered services in §§A and B of this regulation if:</text> <paragraph num="(1)"> <text>The services are rendered in:</text> <paragraph num="(a)"> <text>The dentist's office;</text> </paragraph> <paragraph num="(b)"> <text>The participant's home by an approved mobile dental unit;</text> </paragraph> <paragraph num="(c)"> <text>A general acute hospital;</text> </paragraph> <paragraph num="(d)"> <text>A skilled or intermediate care nursing facility;</text> </paragraph> <paragraph num="(e)"> <text>A free-standing clinic;</text> </paragraph> <paragraph num="(f)"> <text>An EPSDT certified provider's office;</text> </paragraph> <paragraph num="(g)"> <text>An approved mobile dental unit or mobile dental practice;</text> </paragraph> <paragraph num="(h)"> <text>A Medicare-certified ambulatory surgical center; or</text> </paragraph> <paragraph num="(i)"> <text>Via telehealth in compliance with COMAR 10.09.49.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The services are provided by the dentist or one of the following:</text> <paragraph num="(a)"> <text>Another licensed dentist enrolled with Medicaid in the dentist’s employ;</text> </paragraph> <paragraph num="(b)"> <text>A dental hygienist or dental assistant, provided that the individual rendering the service is:</text> <paragraph num="(i)"> <text>In the dentist's employ or in the employ of a public health program;</text> </paragraph> <paragraph num="(ii)"> <text>Under general supervision of a licensed dentist; and</text> </paragraph> <paragraph num="(iii)"> <text>Within the scope of the individual’s training or certification for the purpose of assisting in the provision of dental services; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An EPSDT certified provider for the purpose of applying fluoride varnish;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The services are clearly related to the participant's individual dental care needs as ameliorative, diagnostic, curative, palliative, preventive, or rehabilitative services; and</text> </paragraph> <paragraph num="(4)"> <text>The services are adequately described on the participant's dental care record in accordance with record-keeping practices detailed in COMAR 10.44.30.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The Program places the following limitations upon covered services:</text> <paragraph num="(1)"> <text>Reimbursement for a complete radiographic survey or full series of X-rays of the mouth may not be made more frequently than once every 3 years to the same provider, or in the case of a group practice, to any partner or associate of that practice, unless medically necessary or specifically required or requested by the Program.</text> </paragraph> <paragraph num="(2)"> <text>For any traumatic injury case, a provider may be reimbursed for a maximum of four panoramic or other extra-oral radiographs. When services are rendered by members of a group practice or association, reimbursement to the group practice or association shall also be limited to a maximum of four panoramic or other extra-oral radiographs.</text> </paragraph> <paragraph num="(3)"> <text>Endodontic therapies and pulpectomies may not be covered when:</text> <paragraph num="(a)"> <text>Root resorption has started and exfoliation is imminent;</text> </paragraph> <paragraph num="(b)"> <text>Gross periapical or periodontal pathosis is demonstrated on the radiograph; or</text> </paragraph> <paragraph num="(c)"> <text>The general oral condition does not justify endodontic therapy.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Reimbursement for crowns will be limited to permanent resin fused to metal crowns, permanent porcelain fused to metal crowns, permanent nonprecious metal (full cast), provisional resin crowns, prefabricated zirconia crowns, and stainless steel crowns.</text> </paragraph> <paragraph num="(5)"> <text>Composite restorations will be covered for all teeth when necessary for the particular conditions of the patient.</text> </paragraph> <paragraph num="(6)"> <text>Replacement dentures for participants who meet the requirements of Regulation .04A(3) of this chapter will be covered only when:</text> <paragraph num="(a)"> <text>Dentures have been lost, broken, or stolen after 1 year of placement; or</text> </paragraph> <paragraph num="(b)"> <text>Adjustment, repair, relining, or rebasing of the patient's present denture does not make it serviceable.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Rebasing is included in the 6 months of aftercare following denture placement, and may not be provided more frequently than once every 2 years after that.</text> </paragraph> <paragraph num="(8)"> <text>Reimbursement for endodontic therapy includes all diagnostic tests, preoperative and postoperative radiographs, preoperative and postoperative treatments, pulpotomies and pulpectomies.</text> </paragraph> <paragraph num="(9)"> <text>Reimbursement for a sinus closure will only be made when this service is rendered as a separate procedure and not in conjunction with the removal of a tooth.</text> </paragraph> <paragraph num="(10)"> <text>Separate reimbursement will not be made for cavity liners and office visits, as these procedures are considered to be components of the necessary treatment. These services may not be billed to the participant.</text> </paragraph> <paragraph num="(11)"> <text>The provider may bill for emergency treatment or for the actual dental procedures rendered during an emergency visit, but not for both.</text> </paragraph> <paragraph num="(12)"> <text>Gold restorations, gold crowns, and gold replacement appliances are not covered services.</text> </paragraph> <paragraph num="(13)"> <text>The Program's fee for a complete series of intra-oral radiographs including bitewings, represents the maximum payable for any combination of periapical X-rays and bitewings.</text> </paragraph> <paragraph num="(14)"> <text>Assistant surgeons' services are covered only:</text> <paragraph num="(a)"> <text>As specified in Regulation .07M of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>If the procedures were rendered in a hospital or a Medicare-certified ambulatory surgery center; and</text> </paragraph> <paragraph num="(c)"> <text>If the assistant surgeon is a dentist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Program does not cover:</text> <paragraph num="(1)"> <text>Fixed bridge work;</text> </paragraph> <paragraph num="(2)"> <text>Cosmetic procedures;</text> </paragraph> <paragraph num="(3)"> <text>Inpatient hospital dental or oral health care services rendered during an admission;</text> </paragraph> <paragraph num="(4)"> <text>Services which are investigational or experimental;</text> </paragraph> <paragraph num="(5)"> <text>Local anesthesia as a separate charge;</text> </paragraph> <paragraph num="(6)"> <text>Duplication of dentures;</text> </paragraph> <paragraph num="(7)"> <text>Drugs and supplies dispensed by the dentist which are acquired by the dentist at no cost;</text> </paragraph> <paragraph num="(8)"> <text>Referrals;</text> </paragraph> <paragraph num="(9)"> <text>Diagnostic models as a separate charge;</text> </paragraph> <paragraph num="(10)"> <text>Office visits as a separate service;</text> </paragraph> <paragraph num="(11)"> <text>Immediate dentures;</text> </paragraph> <paragraph num="(12)"> <text>Consultant payments when a member of the house staff of a hospital either requests or provides the consultations or, in the case of a group practice, to any partner or associate of that practice who either requests or provides the consultation;</text> </paragraph> <paragraph num="(13)"> <text>Aftercare services as a separate charge to a provider or, in the case of a group practice, to any partner or associate of that practice;</text> </paragraph> <paragraph num="(14)"> <text>Services when reimbursement is included under another segment of the Program;</text> </paragraph> <paragraph num="(15)"> <text>Unilateral partial dentures replacing fewer than three teeth, excluding third molars;</text> </paragraph> <paragraph num="(16)"> <text>Implants;</text> </paragraph> <paragraph num="(17)"> <text>More than one, per participant per lifetime, of the following services:</text> <paragraph num="(a)"> <text>Traditional comprehensive orthodontic treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Self-ligating braces; and</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Services rendered without the required preauthorization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>Preauthorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>Program limitations are met;</text> </paragraph> <paragraph num="(3)"> <text>The provider submits to the Department, adequate documentation demonstrating that the service to be preauthorized is medically necessary; and</text> </paragraph> <paragraph num="(4)"> <text>The participant is eligible for the service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preauthorization is required for the following:</text> <paragraph num="(1)"> <text>Resin fused to metal crown;</text> </paragraph> <paragraph num="(2)"> <text>Porcelain fused to metal crown;</text> </paragraph> <paragraph num="(3)"> <text>Nonprecious metal crown (full cast);</text> </paragraph> <paragraph num="(4)"> <text>Apicoectomies and periradicular services;</text> </paragraph> <paragraph num="(5)"> <text>Certain periodontal services;</text> </paragraph> <paragraph num="(6)"> <text>Complete upper/lower denture;</text> </paragraph> <paragraph num="(7)"> <text>Partial upper/lower denture (including clasps and teeth);</text> </paragraph> <paragraph num="(8)"> <text>Any elective clinical or surgical procedure not listed on the current dental fee schedule;</text> </paragraph> <paragraph num="(9)"> <text>Surgery normally considered cosmetic but qualified by traumatic or pathological causation;</text> </paragraph> <paragraph num="(10)"> <text>Laboratory rebasing of dentures;</text> </paragraph> <paragraph num="(11)"> <text>Addition of teeth or clasps to an existing, functional complete or partial denture;</text> </paragraph> <paragraph num="(12)"> <text>General restorative treatment to be rendered in a hospital;</text> </paragraph> <paragraph num="(13)"> <text>Special periodontal appliances;</text> </paragraph> <paragraph num="(14)"> <text>Apexification and recalcification procedures;</text> </paragraph> <paragraph num="(15)"> <text>Hemisection, including any root removal, including endodontic therapy;</text> </paragraph> <paragraph num="(16)"> <text>Overdenture complete;</text> </paragraph> <paragraph num="(17)"> <text>Overdenture partial;</text> </paragraph> <paragraph num="(18)"> <text>Condylectomy;</text> </paragraph> <paragraph num="(19)"> <text>Meniscectomy;</text> </paragraph> <paragraph num="(20)"> <text>Arthrotomy; and</text> </paragraph> <paragraph num="(21)"> <text>All orthodontic procedures.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At a minimum, the documentation required when requesting preauthorization for the following services is:</text> <paragraph num="(1)"> <text>A complete radiographic survey of the mouth for:</text> <paragraph num="(a)"> <text>Complete or partial dentures; or</text> </paragraph> <paragraph num="(b)"> <text>Except in the case of special needs children, where sedation would be required for a complete radiograph of the mouth, special periodontal appliances and periodontal therapies;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individual periapical radiographs for:</text> <paragraph num="(a)"> <text>Except in the case of special needs children, where sedation would be required for an individual periapical radiograph or bitewing, endodontic therapy (periapicals and bitewings shall be submitted when the request is for posterior teeth);</text> </paragraph> <paragraph num="(b)"> <text>Apicoectomy;</text> </paragraph> <paragraph num="(c)"> <text>Except in the case of special needs children, where sedation would be required for an individual periapical radiograph, periradicular and apexification or recalcification services; and</text> </paragraph> <paragraph num="(d)"> <text>Full coverage permanent crown restorations (excludes stainless steel and provisional resin crowns); and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Full mouth radiographs and a periodontal chart, identifying the depths and locations of the pockets, when periodontal services are requested.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except as described in §F of this regulation, preauthorization is valid for dental services when the services are approved and completed within 6 months after the date of the receipt of the preauthorization number from the Program.</text> </paragraph> <paragraph num="E."> <text>Preauthorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—D of this regulation.</text> </paragraph> <paragraph num="F."> <text>Preauthorization for Orthodontic Treatment.</text> <paragraph num="(1)"> <text>Preauthorization is required for traditional comprehensive orthodontic treatment and for self-ligating braces for the correction of medically necessary conditions, which cause dysfunction due to a handicapping malocclusion. At a minimum the following comprehensive pretreatment documentation shall be submitted:</text> <paragraph num="(a)"> <text>Cephalometric head film with analysis;</text> </paragraph> <paragraph num="(b)"> <text>Panoramic or full series of periapical radiographs;</text> </paragraph> <paragraph num="(c)"> <text>68 diagnostic quality extra-oral and intra-oral photographs;</text> </paragraph> <paragraph num="(d)"> <text>Clinical summary with diagnosis;</text> </paragraph> <paragraph num="(e)"> <text>HLD score sheets from attending orthodontist; and</text> </paragraph> <paragraph num="(f)"> <text>Treatment plan.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Preauthorization for periodic orthodontic treatment is valid for:</text> <paragraph num="(a)"> <text>24 months for traditional comprehensive orthodontic treatment; or</text> </paragraph> <paragraph num="(b)"> <text>12 months for self-ligating braces.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>To obtain compensation from the Department for covered services, the provider shall submit a request for payment on the form designated by the Department with the following data or attachments:</text> <paragraph num="(1)"> <text>If applicable, the preauthorization number shall be inserted in the designated appropriate field on the invoice claim form;</text> </paragraph> <paragraph num="(2)"> <text>If applicable, pathology reports shall be attached to the claim form; and</text> </paragraph> <paragraph num="(3)"> <text>If applicable, comprehensive narratives shall be attached to the claim form for those services that are “By Report”.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed or completed.</text> </paragraph> <paragraph num="C."> <text>All prosthetic appliances shall be inserted in the mouth and adjusted before the Program is billed, except when the patient has expired, cannot be located, or refuses to return for completion of treatment. In these cases, the Department will reimburse the provider 80 percent of the maximum State fee for the procedure code for the laboratory bill only.</text> </paragraph> <paragraph num="D."> <text>The provider shall charge the Program the provider's customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §E of this regulation; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The current Maryland Medicaid Dental Services Fee Schedule and Procedure Codes CDT is incorporated by reference, effective January 1, 2024.</text> </paragraph> <paragraph num="F."> <text>The provider shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The rate in accordance with the Department's fee schedule.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The provider may not bill the Department or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a participant's medical record when requested by another licensed provider on the participant's behalf.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reimbursement for Traditional Comprehensive Orthodontic Treatment.</text> <paragraph num="(1)"> <text>The Program shall reimburse for orthodontic treatment for a maximum of 24 periodic visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F.</text> </paragraph> <paragraph num="(2)"> <text>Orthodontic treatment is a once in a lifetime benefit.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Reimbursement for Self-Ligating Braces.</text> <paragraph num="(1)"> <text>The Program shall reimburse for:</text> <paragraph num="(a)"> <text>A pre-orthodontic visit;</text> </paragraph> <paragraph num="(b)"> <text>Comprehensive orthodontia; and</text> </paragraph> <paragraph num="(c)"> <text>A maximum of 12 periodic treatment visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a claim is submitted to the Program for the banding of self-ligating braces, the following documentation shall be submitted with the claim:</text> <paragraph num="(a)"> <text>A photograph of the recipient's oral cavity to confirm the placement of self-ligating braces; and</text> </paragraph> <paragraph num="(b)"> <text>A statement signed by the parent or guardian of the child receiving treatment, acknowledging that:</text> <paragraph num="(i)"> <text>Orthodontic services are a once in a lifetime benefit; and</text> </paragraph> <paragraph num="(ii)"> <text>The participant will not be able to pursue additional orthodontic services from the Medicaid Program at a later date.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>The Department may not make direct payment to nurses, dental assistants, anesthetists, or dental hygienists.</text> </paragraph> <paragraph num="K."> <text>The Department may not make direct payment to the participant.</text> </paragraph> <paragraph num="L."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="M."> <text>Those dental clinics licensed as part of a hospital in Maryland may charge and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC) pursuant to COMAR 10.37.03.</text> </paragraph> <paragraph num="N."> <text>Payment for assistant surgeons' services is a maximum of 20 percent of the listed fee paid to the primary surgeon or the fee as determined by the Program for the treatment rendered. The minimum allowance is $25 or the dentist's charge, whichever is lower.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, dentist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="D."> <text>Any provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify participants that the provider no longer honors Medical Assistance cards before rendering additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <paragraph num="A."> <text>Providers may exercise appeal rights pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The provider may appeal a decision to the Office of Administrative Hearings as specified in COMAR 10.09.36.09.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an attempt by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 amended effective October 13, 1976 (3:21 Md. R. 1206)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01I, .04A, .05, and .06B amended as an emergency provision effective February 1, 1982 (9:2 Md. R. 110); emergency status extended at 9:11 Md. R. 1122 and 9:17 Md. R. 1697 (Emergency provisions are temporary and are not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C adopted effective April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended to June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 1, 1983 (9:25 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .04, and .05 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 1, 1985 (12:19 Md. R. 1848); August 27, 2007 (34:17 Md. R. 1507); May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511); March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512); October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective November 15, 2021 (48:23 Md. R. 979); October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04A, .05A, and .07E amended, and .07N adopted as an emergency provision effective February 1, 1989 (16:3 Md. R. 336); adopted permanently effective June 1, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 1, 1985(12:19 Md. R. 1848); May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 20, 2019 (46:10 Md. R. 485); October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective November 15, 2021 (48:23 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C repealed effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 15, 2021 (48:23 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 1, 1985 (12:19 Md. R. 1848); December 24, 1990 (17:25 Md. R. 2907); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective December 27, 2010 (37:26 Md. R. 1787); March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 1, 1985 (12:19 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, F, G amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 20, 1998 (25:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2052); adopted permanently effective January 21, 2002 (29:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective March 25, 2004 (31:8 Md. R. 643); amended permanently effective June 21, 2004 (31:12 Md. R. 911)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective August 15, 2005 (32:16 Md. R. 1392); August 27, 2007 (34:17 Md. R. 1508); March 30, 2015 (42:6 Md. R. 511); October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E, G amended effective August 27, 2018 (45:17 Md. R. 803)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E, I amended effective November 15, 2021 (48:23 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E, I, K amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 14, 2017 (44:16 Md. R. 808)</annotation> </annotations> </chapter> <chapter num="06" heading="Adult Residential Substance Use Disorder Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs residential substance use disorder services for adults, effective July 1, 2017.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accrediting body” means an entity approved by the Secretary or the Secretary’s designee, under Health-General Article, §19-2302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative day” means a day of services rendered to a participant who no longer requires the level of care the provider is licensed to deliver, but still requires the level of care in an ASAM Level 3.3, 3.5, or 3.7 setting.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative service organization (ASO)” means the entity under contract with the Department to provide administrative services to operate the Maryland Public Behavioral Health System.</text> </paragraph> <paragraph num="(4)"> <text>“American Society of Addiction Medicine (ASAM) criteria” means an instrument designed to indicate placement guidelines for admission, continued stay, and discharge of individuals with a substance use disorder.</text> </paragraph> <paragraph num="(5)"> <text>“Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.</text> </paragraph> <paragraph num="(6)"> <text>“Available” means a staff member is on-site, available by phone, or on call.</text> </paragraph> <paragraph num="(7)"> <text>“Behavioral Health Administration” means the administration within the Department that establishes regulatory requirements that behavioral health providers are to maintain in order to become certified or licensed by the Department.</text> </paragraph> <paragraph num="(8)"> <text>“Certified counselor” means a provider approved by the Board of Professional Counselors and Therapists under COMAR 10.58.</text> </paragraph> <paragraph num="(9)"> <text>“Coordinating aftercare services” means being responsible for assisting participants with resources, appointments, and discharge plans.</text> </paragraph> <paragraph num="(10)"> <text>“Crisis intervention” means the methods used to offer short term immediate help to individuals who have experienced an event that produces mental, physical, emotional, and behavioral distress.</text> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment.</text> </paragraph> <paragraph num="(13)"> <text>“Documentation” means the written medical record.</text> </paragraph> <paragraph num="(14)"> <text>“Evidence-based practice” means a practice approved by the Behavioral Health Administration that applies to certain clinical or rehabilitative interventions provided by public mental health service providers.</text> </paragraph> <paragraph num="(15)"> <text>“Facility director” means an individual on staff who is responsible for overseeing the daily operation of the residential treatment facility.</text> </paragraph> <paragraph num="(16)"> <text>“Individualized treatment plan” means a written plan that:</text> <paragraph num="(a)"> <text>Addresses the individual’s biopsychosocial needs through goals and objectives; and</text> </paragraph> <paragraph num="(b)"> <text>Is updated as needed according to the treatment modality.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“License” means the approval issued by the Secretary or designee that permits a behavioral health provider to operate in Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Licensed mental health clinician” means a staff member who is eligible to provide mental health services as outlined in COMAR 10.09.59.04A.</text> </paragraph> <paragraph num="(19)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals.</text> </paragraph> <paragraph num="(20)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(21)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(22)"> <text>“Participant” census means a record of participants actively in the care of the provider.</text> </paragraph> <paragraph num="(23)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(24)"> <text>“Progress” note means an objective documentation of the participants progress in relation to specific treatment goals and objectives.</text> </paragraph> <paragraph num="(25)"> <text>“Provider” means a residential treatment facility that provides professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting.</text> </paragraph> <paragraph num="(26)"> <text>“Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.</text> </paragraph> <paragraph num="(27)"> <text>“Substance use disorder services” means the services for which a participants diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Requirements."> <text>To participate in the Program, a provider shall:</text> <paragraph num="A."> <text>Meet the license requirements stated in COMAR 10.09.36.02 and, after April 1, 2018, COMAR 10.63.01.05;</text> </paragraph> <paragraph num="B."> <text>Be accredited by a Maryland-approved accrediting body; and</text> </paragraph> <paragraph num="C."> <text>Be licensed by the Behavioral Health Administration (BHA) for each level of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Comply with requirements set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate in the Program as a residential substance use disorder provider, the provider shall:</text> <paragraph num="(1)"> <text>Be in compliance with COMAR 10.63.03 as applicable to each ASAM level of care;</text> </paragraph> <paragraph num="(2)"> <text>Be in compliance with all ASAM requirements for each applicable level of care;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate competence in the ability to deliver a minimum of three evidence-based practice services;</text> </paragraph> <paragraph num="(4)"> <text>Complete all required documentation associated with the application process;</text> </paragraph> <paragraph num="(5)"> <text>Maintain verification of licenses and credentials, including background checks, of all professionals employed by or under contract with the provider in their respective personnel files;</text> </paragraph> <paragraph num="(6)"> <text>Maintain staffing within each ASAM level of care as described in §§C—G of this regulation;</text> </paragraph> <paragraph num="(7)"> <text>Increase staffing within each ASAM level of care at a ratio to correspond with the participant census to meet required ASAM level of service delivery for each patient;</text> </paragraph> <paragraph num="(8)"> <text>Maintain adequate documentation of each clinical contact with a participant as part of the medical record, which includes, at a minimum:</text> <paragraph num="(a)"> <text>An individualized treatment plan;</text> </paragraph> <paragraph num="(b)"> <text>The date of all clinical encounters with start and end times and a description of services provided;</text> </paragraph> <paragraph num="(c)"> <text>Documentation of all clinical services received by the participant;</text> </paragraph> <paragraph num="(d)"> <text>Progress notes updated on each day services are provided;</text> </paragraph> <paragraph num="(e)"> <text>An individualized discharge plan; and</text> </paragraph> <paragraph num="(f)"> <text>An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title on all clinical progress notes;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Maintain adequate documentation indicating that the participant continues to meet the medical necessity criteria for the applicable ASAM level of care;</text> </paragraph> <paragraph num="(10)"> <text>Make the documentation required under this subtitle, or necessary to substantiate compliance with this subtitle, available as requested to carry out required activities, to the:</text> <paragraph num="(a)"> <text>Department;</text> </paragraph> <paragraph num="(b)"> <text>ASO;</text> </paragraph> <paragraph num="(c)"> <text>Core Service Agency;</text> </paragraph> <paragraph num="(d)"> <text>Local addictions authority;</text> </paragraph> <paragraph num="(e)"> <text>Local behavioral health authority;</text> </paragraph> <paragraph num="(f)"> <text>Office of Inspector General of the Department; and</text> </paragraph> <paragraph num="(g)"> <text>Office of the Attorney General Medicaid Fraud Control Unit; and</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.04 Participant Eligibility and Referral.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A residential, low-intensity level 3.1 provider shall:</text> <paragraph num="(1)"> <text>Provide therapeutic services for a minimum of 5 hours per week;</text> </paragraph> <paragraph num="(2)"> <text>Coordinate aftercare services through:</text> <paragraph num="(a)"> <text>Peer support; or</text> </paragraph> <paragraph num="(b)"> <text>A licensed provider;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At a minimum, maintain the following staff:</text> <paragraph num="(a)"> <text>A part-time program director on-site 20 hours per week;</text> </paragraph> <paragraph num="(b)"> <text>A clinical director serving the program 20 hours per week who:</text> <paragraph num="(i)"> <text>May also be the program director;</text> </paragraph> <paragraph num="(ii)"> <text>Is responsible for the supervision of the program’s clinical services, counselors, peer support staff, and coordination of all care provided by outside programs; and</text> </paragraph> <paragraph num="(iii)"> <text>Is identified under COMAR 10.09.59.04 as an individual practitioner provider or certified and approved by the Board of Professional Counselors and Therapists as a supervisor;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A licensed or certified counselor on-site 40 hours per week;</text> </paragraph> <paragraph num="(d)"> <text>Peer support staff; and</text> </paragraph> <paragraph num="(e)"> <text>At least one staff member on duty between 11 p.m. and 7 a.m. who is:</text> <paragraph num="(i)"> <text>Certified in cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(ii)"> <text>Certified in Narcan administration; and</text> </paragraph> <paragraph num="(iii)"> <text>Trained in crisis intervention.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A residential, medium intensity level 3.3 provider shall:</text> <paragraph num="(1)"> <text>Have sufficient physician, physician assistant, or nurse practitioner services to:</text> <paragraph num="(a)"> <text>Provide initial diagnostic work-up;</text> </paragraph> <paragraph num="(b)"> <text>Provide identification of medical and surgical problems for referral; and</text> </paragraph> <paragraph num="(c)"> <text>Handle medical emergencies when necessary;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide therapeutic activities from 20 to 35 hours per week;</text> </paragraph> <paragraph num="(3)"> <text>Coordinate aftercare services through:</text> <paragraph num="(a)"> <text>Peer support; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have at least one staff member:</text> <paragraph num="(a)"> <text>Certified in cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(b)"> <text>Trained in crisis intervention; and</text> </paragraph> <paragraph num="(c)"> <text>On duty between 11 p.m. and 7 a.m.;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have a part-time facility director on-site 20 hours per week; and</text> </paragraph> <paragraph num="(6)"> <text>At a minimum, maintain the following staff:</text> <paragraph num="(a)"> <text>A physician, nurse practitioner, or physician assistant on-site 4 hours per week and 1 hour on call;</text> </paragraph> <paragraph num="(b)"> <text>A psychiatrist or psychiatric nurse practitioner available 3 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse or licensed practical nurse on-site 40 hours per week; and</text> </paragraph> <paragraph num="(d)"> <text>An on-site multi-disciplinary team consisting of:</text> <paragraph num="(i)"> <text>A clinical supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed mental health clinician;</text> </paragraph> <paragraph num="(iii)"> <text>A certified counselor under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and</text> </paragraph> <paragraph num="(iv)"> <text>Peer support staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A residential, high intensity level 3.5 provider shall:</text> <paragraph num="(1)"> <text>Have sufficient physician, physician assistant, or nurse practitioner services to:</text> <paragraph num="(a)"> <text>Provide initial diagnostic work-up;</text> </paragraph> <paragraph num="(b)"> <text>Provide identification of medical and surgical problems for referral; and</text> </paragraph> <paragraph num="(c)"> <text>Handle medical emergencies when necessary;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide a minimum of 36 hours of therapeutic activities per week;</text> </paragraph> <paragraph num="(3)"> <text>Coordinate aftercare services through:</text> <paragraph num="(a)"> <text>Peer support; or</text> </paragraph> <paragraph num="(b)"> <text>A licensed provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have at least one staff member:</text> <paragraph num="(a)"> <text>Certified in cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(b)"> <text>Trained in crisis intervention; and</text> </paragraph> <paragraph num="(c)"> <text>On duty between 11 p.m. and 7 a.m.;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have a part-time facility director on-site 20 hours per week; and</text> </paragraph> <paragraph num="(6)"> <text>At a minimum, have the following staff:</text> <paragraph num="(a)"> <text>A physician, nurse practitioner, or physician assistant on-site 1 hour per week;</text> </paragraph> <paragraph num="(b)"> <text>A psychiatrist or psychiatric nurse practitioner available 1 hour per week;</text> </paragraph> <paragraph num="(c)"> <text>An on-site multi-disciplinary team consisting of:</text> <paragraph num="(i)"> <text>A clinical supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed mental health clinician;</text> </paragraph> <paragraph num="(iii)"> <text>Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and</text> </paragraph> <paragraph num="(iv)"> <text>Peer support staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A residential, intensive level 3.7 provider shall:</text> <paragraph num="(1)"> <text>Have sufficient physician, physician assistant, or nurse practitioner services to:</text> <paragraph num="(a)"> <text>Provide initial diagnostic work-up;</text> </paragraph> <paragraph num="(b)"> <text>Provide identification of medical and surgical problems for referral; and</text> </paragraph> <paragraph num="(c)"> <text>Handle medical emergencies when necessary;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide a minimum of 36 hours of therapeutic activities per week;</text> </paragraph> <paragraph num="(3)"> <text>Coordinate aftercare services through:</text> <paragraph num="(a)"> <text>Peer support; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have at least two staff members:</text> <paragraph num="(a)"> <text>Certified in cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(b)"> <text>Trained in crisis management; and</text> </paragraph> <paragraph num="(c)"> <text>On duty between 11 p.m. and 7 a.m.;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have a part-time facility director on-site 20 hours per week; and</text> </paragraph> <paragraph num="(6)"> <text>At a minimum, have on staff a:</text> <paragraph num="(a)"> <text>Physician, nurse practitioner, or physician assistant on-site 5 hours per week and 2 hours on call;</text> </paragraph> <paragraph num="(b)"> <text>Psychiatrist or psychiatric nurse practitioner available 10 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>Nurse on-site 168 hours per week, with a minimum of 56 hours provided by a registered nurse;</text> </paragraph> <paragraph num="(d)"> <text>On-site multi-disciplinary team consisting of:</text> <paragraph num="(i)"> <text>A clinical supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed mental health clinician;</text> </paragraph> <paragraph num="(iii)"> <text>Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and</text> </paragraph> <paragraph num="(iv)"> <text>Peer support staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A withdrawal management service level 3.7-WM provider shall:</text> <paragraph num="(1)"> <text>Have a part-time facility director on-site 20 hours per week;</text> </paragraph> <paragraph num="(2)"> <text>Coordinate aftercare services through:</text> <paragraph num="(a)"> <text>Peer support; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed provider; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At a minimum, have on staff:</text> <paragraph num="(a)"> <text>A physician, nurse practitioner, or physician assistant on-site 20 hours per week and 4 hours on call;</text> </paragraph> <paragraph num="(b)"> <text>A psychiatrist or psychiatric nurse practitioner available 8 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse on-site 56 hours per week;</text> </paragraph> <paragraph num="(d)"> <text>A licensed practical nurse on-site 112 hours per week; and</text> </paragraph> <paragraph num="(e)"> <text>An on-site multi-disciplinary team consisting of:</text> <paragraph num="(i)"> <text>A clinical supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed mental health clinician;</text> </paragraph> <paragraph num="(iii)"> <text>Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and</text> </paragraph> <paragraph num="(iv)"> <text>Peer support staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Eligibility and Referral."> <text>A participant is eligible for substance use disorder services under this chapter if the participant:</text> <paragraph num="A."> <text>Is enrolled in the Program and is not enrolled in Medicare on the day a service is rendered;</text> </paragraph> <paragraph num="B."> <text>Meets the Department’s medical necessity criteria based on the ASAM placement criteria for each level of care; and</text> </paragraph> <paragraph num="C."> <text>Is 18 years old or older and is not receiving care from a provider under COMAR 10.09.23.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>A residential, low intensity level 3.1 provider shall provide:</text> <paragraph num="(1)"> <text>Therapeutic substance use disorder services for a minimum of 5 hours per week; and</text> </paragraph> <paragraph num="(2)"> <text>Services in a structured environment in combination with low-intensity treatment and ancillary services to support and promote recovery.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A residential-medium intensity level 3.3 provider shall:</text> <paragraph num="(1)"> <text>Provide clinically managed substance use disorder treatment 20 to 35 hours per week based on a comprehensive assessment; and</text> </paragraph> <paragraph num="(2)"> <text>Provide services in a structured environment in combination with medium-intensity treatment and ancillary services to support and promote recovery.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A residential, high intensity level 3.5 provider shall:</text> <paragraph num="(1)"> <text>Provide clinically managed substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and</text> </paragraph> <paragraph num="(2)"> <text>Provide services in a highly structured environment, in combination with medium-intensity to high-intensity treatment and ancillary services to support and promote recovery.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A residential-intensive level 3.7 provider shall:</text> <paragraph num="(1)"> <text>Provide medically monitored, intensive substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and</text> </paragraph> <paragraph num="(2)"> <text>Offer a planned regimen of 24-hour professionally directed evaluation, care, and treatment in an inpatient setting.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A withdrawal management service level 3.7 provider shall offer 24-hour medically supervised evaluation and withdrawal management.</text> </paragraph> <paragraph num="F."> <text>The Program shall cover services under this chapter rendered via telehealth in accordance with COMAR 10.09.49 when:</text> <paragraph num="(1)"> <text>Provided by licensed or certified staff;</text> </paragraph> <paragraph num="(2)"> <text>The originating site at which the participant receives the service is the adult residential substance use disorder service site; and</text> </paragraph> <paragraph num="(3)"> <text>Total services rendered via telehealth comprise no more than 50 percent of all clinical services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <text>The Program does not cover the following in a residential substance use disorder treatment facility for adults:</text> <paragraph num="A."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="B."> <text>ASAM Level 2 services by any provider;</text> </paragraph> <paragraph num="C."> <text>Except for services rendered to individuals in a residential, low-intensity program, ASAM Level 1 services by any provider;</text> </paragraph> <paragraph num="D."> <text>Services not specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="E."> <text>Services beyond the provider’s scope of practice;</text> </paragraph> <paragraph num="F."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="G."> <text>Services rendered but not appropriately documented; and</text> </paragraph> <paragraph num="H."> <text>Services not preauthorized as required in Regulation .08 of this chapter.</text> </paragraph> <paragraph num="I."> <text>Additional services rendered via telehealth when telehealth services comprise more than 50 percent of a participant's weekly clinical services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Authorization Requirements."> <paragraph num="A."> <text>The provider shall obtain authorization from the ASO to provide residential substance use disorder services outlined in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The ASO agent shall authorize services that are:</text> <paragraph num="(1)"> <text>Medically necessary for the applicable level of service as outlined by ASAM criteria for admission; and</text> </paragraph> <paragraph num="(2)"> <text>Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness.</text> </paragraph> </paragraph> <paragraph num="C."> <text>No payment shall be rendered for services that have not been authorized by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>For dates of service from July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For ASAM Level 3.1, the provider shall receive $104.62 per diem;</text> </paragraph> <paragraph num="(2)"> <text>For ASAM Level 3.3, the provider shall receive $233.14 per diem;</text> </paragraph> <paragraph num="(3)"> <text>For ASAM Level 3.5, the provider shall receive $233.14 per diem;</text> </paragraph> <paragraph num="(4)"> <text>For ASAM Level 3.7, the provider shall receive $358.93 per diem; and</text> </paragraph> <paragraph num="(5)"> <text>For ASAM Level 3.7-WM, the provider shall receive $436.38 per diem.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For dates of service from January 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For ASAM Level 3.1, the provider shall receive $112.99 per diem;</text> </paragraph> <paragraph num="(2)"> <text>For ASAM Level 3.3, the provider shall receive $251.79 per diem;</text> </paragraph> <paragraph num="(3)"> <text>For ASAM Level 3.5, the provider shall receive $251.79 per diem;</text> </paragraph> <paragraph num="(4)"> <text>For ASAM Level 3.7, the provider shall receive $387.64 per diem; and</text> </paragraph> <paragraph num="(5)"> <text>For ASAM Level 3.7-WM, the provider shall receive $471.40 per diem.</text> </paragraph> </paragraph> <paragraph num="E."> <text>For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For ASAM Level 3.1, the provider shall receive $116.38 per diem;</text> </paragraph> <paragraph num="(2)"> <text>For ASAM Level 3.3, the provider shall receive $259.34 per diem;</text> </paragraph> <paragraph num="(3)"> <text>For ASAM Level 3.5, the provider shall receive $259.34 per diem;</text> </paragraph> <paragraph num="(4)"> <text>For ASAM Level 3.7, the provider shall receive $399.27 per diem; and</text> </paragraph> <paragraph num="(5)"> <text>For ASAM Level 3.7-WM, the provider shall receive $485.54 per diem.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Administrative Days. The Department shall pay at the daily rate based on the patient’s ASAM level of care when:</text> <paragraph num="(1)"> <text>The participant’s required level of care has changed, and the following conditions are met:</text> <paragraph num="(a)"> <text>The provider has implemented a predischarge planning program and initiated placement activities for the participant at the earliest appropriate time;</text> </paragraph> <paragraph num="(b)"> <text>The provider has actively pursued placement of the participant at the required level of care in an appropriate facility during the entire period of administrative days;</text> </paragraph> <paragraph num="(c)"> <text>The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §E(1)(a)—(b) of this regulation for the entire period of the administrative stay claimed for reimbursement; and</text> </paragraph> <paragraph num="(d)"> <text>The participant is transferred promptly to the first available appropriate facility licensed and certified for the required level of care; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The participant is at an inappropriate level of care but cannot be moved, and the following conditions are met:</text> <paragraph num="(a)"> <text>The attending physician has declared that, because of physical or emotional problems, the participant is unable to be moved; and</text> </paragraph> <paragraph num="(b)"> <text>The reason the participant cannot be moved is adequately documented by the attending physician in the participant’s record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeals Procedures."> <text>Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7.5-204(c), 7.5-205(d), 15-105(b), and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 11, 2017 (44:18 Md. R. 865)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 4, 2022 (49:7 Md. R. 465); October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F adopted effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 30, 2019 (46:26 Md. R. 1164); October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective October 16, 2023 (50:20 Md. R. 886); September 16, 2024 (51:18 Md. R. 808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective December 31, 2018 (45:26 Md. R. 1242); December 30, 2019 (46:26 Md. R. 1164); April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D—E amended effective April 4, 2022 (49:7 Md. R. 465); November 24, 2025 (52:23 Md. R. 1138)</annotation> </annotations> </chapter> <chapter num="07" heading="Medical Day Care Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adult Day Care Assessment and Planning System (ADCAPS)” means a system that is comprised of a comprehensive assessment completed by a registered nurse, which is designed to evaluate the participant’s strengths and needs, and to facilitate the development of a problem list, service plan, and plan of care.</text> </paragraph> <paragraph num="(2)"> <text>“Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants.</text> </paragraph> <paragraph num="(3)"> <text>“Advance directive” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Community Settings Questionnaire” means the participant survey, completed annually or when a participant changes medical day care centers or sites, that is part of the State’s strategy to validate provider compliance with federal requirements on home and community based settings.</text> </paragraph> <paragraph num="(5)"> <text>“Daily attendance record” means a daily attendance account of the physical presence of each medical day care participant that:</text> <paragraph num="(a)"> <text>Is designed by the provider;</text> </paragraph> <paragraph num="(b)"> <text>Is signed and dated by the staff designated to take attendance or by the medical day care director; and</text> </paragraph> <paragraph num="(c)"> <text>Includes the name, medical assistance number, date of service, and arrival and departure times, of each participant, including documentation of time of temporary absences.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Home and community based services waiver” means a program implemented by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified federal statutory requirements limiting coverage for home and community based services under the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed practical nurse” means an individual licensed to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Licensed social worker” means an individual who is licensed to practice social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Maintenance services” means the periodic monitoring of medically stable patients and the services provided in order to maintain their health care status.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients.</text> </paragraph> <paragraph num="(12)"> <text>“Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living.</text> </paragraph> <paragraph num="(13)"> <text>“Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically handicapped adults who do not require 24-hour inpatient care, but, due to their degree of impairment, are not capable of full-time independent living.</text> </paragraph> <paragraph num="(14)"> <text>“Medical director” means an individual who is:</text> <paragraph num="(a)"> <text>Licensed to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Employed by the medical day care center either as a staff member or by a contractual agreement.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Medically handicapped adult” has the meaning stated in Health-General Article, §14-301(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Medically necessary” means that a service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, health care professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care.</text> </paragraph> <paragraph num="(18)"> <text>“Occupational therapist” means an individual who practices occupational therapy under Health Occupations Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19)"> <text>“Occupational therapy” means medically prescribed treatment concerned with improving or restoring functions which have been impaired by illness or injury or, when function has been permanently lost or reduced by illness or injury, concerned with improving the individual's ability to perform those tasks for independent functioning.</text> </paragraph> <paragraph num="(20)"> <text>“Participant” means an individual:</text> <paragraph num="(a)"> <text>Who is a medically handicapped adult as defined under §B(14) of this regulation and who is certified by the Department or its designee as requiring nursing facility services, as defined under COMAR 10.09.10, but whose condition does not require institutional care if medical day care services or other services that provide alternatives to institutional care are available;</text> </paragraph> <paragraph num="(b)"> <text>Who is enrolled in a home and community based services waiver that includes medical day care as a waiver service; and</text> </paragraph> <paragraph num="(c)"> <text>Whose disabilities and needs cannot be satisfactorily and totally met in an episodic ambulatory care setting but require participation at least 1 day a week in a day-long rehabilitative or maintenance ambulatory care program which provides a mix of medical and social services and is authorized in the participant’s home and community based services waiver service plan.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Personal care services” means assistance with activities of daily living.</text> </paragraph> <paragraph num="(22)"> <text>“Physical therapist” means an individual licensed to practice physical therapy under Health Occupations Article, Title 13, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Physical therapy” means treatment of disease and injury through use of:</text> <paragraph num="(a)"> <text>Therapeutic exercise and modalities of heat, cold, water, light, electricity, massage and radiant energy (other than roentgen rays, radium or use of electricity for cauterization in surgery); or</text> </paragraph> <paragraph num="(b)"> <text>Administration and interpretation of tests and measurements of neuromuscular and musculoskeletal functions; or</text> </paragraph> <paragraph num="(c)"> <text>Both §B(22)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22, based upon a medical order and an assessment of the participant’s health status and special care requirements.</text> </paragraph> <paragraph num="(25)"> <text>“Preventive services” means those services designed to prevent the occurrence and/or progression of disease at an early stage before complications and serious disabilities develop.</text> </paragraph> <paragraph num="(26)"> <text>“Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant.</text> </paragraph> <paragraph num="(27)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(28)"> <text>“Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department and identified as a provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(29)"> <text>“Provider agreement” means a contract between the Department of Health and the provider of medical day care, specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation in medical day care.</text> </paragraph> <paragraph num="(30)"> <text>“Recipient” means a person who is certified for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(31)"> <text>“Referral” means to direct a participant, family member, or caretaker to the appropriate community agency or health care provider, or to contact the agency or provider on the participant's behalf, to facilitate access to needed services.</text> </paragraph> <paragraph num="(32)"> <text>“Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(34)"> <text>“Service Plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community.</text> </paragraph> <paragraph num="(35)"> <text>“Significant change in condition” means a change in the participant’s physical, mental, or psychological status as identified by the comprehensive assessment performed by a registered nurse.</text> </paragraph> <paragraph num="(36)"> <text>“Specially equipped vehicles” means those vehicles used to transport participants with severe physical disabilities that limit mobility.</text> </paragraph> <paragraph num="(37)"> <text>“Supervision” means initial direction or periodic monitoring of the actual activity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <text>The provider shall be licensed under COMAR 10.12.04.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>Requirements for providing medical day care services are that the providers shall:</text> <paragraph num="A."> <text>Meet the licensure requirements as provided in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Meet the requirements of COMAR 10.09.36;</text> </paragraph> <paragraph num="C."> <text>Be open to participants at least 6 hours a day, 5 days a week, and post hours of operation;</text> </paragraph> <paragraph num="D."> <text>Verify the licenses and credentials for all professionals employed by or contracting with the medical day care center;</text> </paragraph> <paragraph num="E."> <text>Provide or arrange for the provision of any covered service, as specified in Regulation .05 of this chapter, or any other service which is required by a plan of care;</text> </paragraph> <paragraph num="F."> <text>Demonstrate to the satisfaction of the Program that a need exists for medical day care in the service area and that the provider has the necessary expertise to deliver the service;</text> </paragraph> <paragraph num="G."> <text>Have policies and procedures as required under COMAR 10.12.04;</text> </paragraph> <paragraph num="H."> <text>Maintain medical records for each participant which shall include, as a minimum, the following:</text> <paragraph num="(1)"> <text>An application for admission;</text> </paragraph> <paragraph num="(2)"> <text>The medical day care center's plan of care as required under §M(3)—(4) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>The current home and community based services waiver service plan or the approved medical day care preauthorization form for the participant;</text> </paragraph> <paragraph num="(4)"> <text>Medical orders for all services rendered which may include, but is not limited to, the:</text> <paragraph num="(a)"> <text>Type and duration of service;</text> </paragraph> <paragraph num="(b)"> <text>Frequency of service; and</text> </paragraph> <paragraph num="(c)"> <text>Dosage and frequency of medications when prescribed;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The medical history, chronic illnesses, principal and significant diagnoses, prognoses, prescribed medications, special diets, allergies, and assessments of the recipient's physical and mental status specifying the general types of activities the recipient can and cannot do;</text> </paragraph> <paragraph num="(6)"> <text>The documentation of daily nursing observations for the first 5 days of attendance, and monthly after the first 5 days of attendance; and</text> </paragraph> <paragraph num="(7)"> <text>The initial social history, ADCAPS assessment, and, when needed, social service and activity progress notes;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Have an emergency plan for each participant which includes, as a minimum, an easily located file on each participant, listing:</text> <paragraph num="(1)"> <text>The name and telephone number of the participant’s primary care provider;</text> </paragraph> <paragraph num="(2)"> <text>The advance directive in accordance with Health-General Article, §5-602, if requested or made by the participant;</text> </paragraph> <paragraph num="(3)"> <text>All allergies identified by the participant or the participant’s primary care provider;</text> </paragraph> <paragraph num="(4)"> <text>The treatments or medications for a participant's conditions; and</text> </paragraph> <paragraph num="(5)"> <text>The name and telephone number of a family member, caregiver, or friend to be notified in case of emergency;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Provide training for medical day care staff in emergency procedures, including cardiopulmonary resuscitation and first aid;</text> </paragraph> <paragraph num="K."> <text>Have accurate daily attendance records that are easily retrievable and available for review by the Program;</text> </paragraph> <paragraph num="L."> <text>Have accurate daily transportation records that are easily retrievable and available for review by the Program, and shall include, as a minimum, each participant's transportation plan;</text> </paragraph> <paragraph num="M."> <text>Establish a multidisciplinary team who shall:</text> <paragraph num="(1)"> <text>Assess the participant to determine the appropriateness of the medical day care center's care, interventions, and activities;</text> </paragraph> <paragraph num="(2)"> <text>Determine the medical, psychosocial, and functional status of each participant by:</text> <paragraph num="(a)"> <text>Establishing the ADCAPS evaluations on the date of admission; and</text> </paragraph> <paragraph num="(b)"> <text>Completing the assessment with an initial plan of care within 30 days, after which the ADCAPS evaluations shall be conducted every 4 months;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Develop an individual plan of care in conjunction with the service plan;</text> </paragraph> <paragraph num="(4)"> <text>Review and update with the participant or participant’s representative, the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported; and</text> </paragraph> <paragraph num="(5)"> <text>Obtain the signature of the participant or the participant’s representative to document their approval of the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Have a quality assurance program which includes, as a minimum, health care audits and utilization reviews that:</text> <paragraph num="(1)"> <text>Consist of a review of medical records on all participants that evaluate the appropriateness of admissions, the efficiency, adequacy, and coordination of provided services, and the length of stay and discharge practices, as needed;</text> </paragraph> <paragraph num="(2)"> <text>Include the following elements:</text> <paragraph num="(a)"> <text>Development of outcome criteria for presenting problems common to the medical day care center's participants;</text> </paragraph> <paragraph num="(b)"> <text>Description of actual outcomes as abstracted from the medical day care center's medical records for all the participants served over a specific time period for each presenting problem for which outcome criteria have been developed;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of actual outcomes compared with the outcome criteria to identify problem areas or reasons for suboptimal care;</text> </paragraph> <paragraph num="(d)"> <text>Documented submission of recommended corrective action to the program director; and</text> </paragraph> <paragraph num="(e)"> <text>Reassessment of the appropriateness of the recommended corrective action as revealed by the outcomes of the next audit; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is signed and dated by the program director or designee; and</text> </paragraph> </paragraph> <paragraph num="O."> <text>Have a signed and dated corrective action plan transferring the participant to the appropriate service, if it is determined that the medical day care center's program is not appropriate for an individual participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing Requirements."> <paragraph num="A."> <text>The medical day care center shall have adequate staffing capability to monitor the participants at all times. The composition of the staff depends in part on the needs of the participants and on the number of participants the medical day care center serves. At a minimum, the medical day care center shall meet the requirements of COMAR 10.12.04.14.</text> </paragraph> <paragraph num="B."> <text>The medical day care center shall also have:</text> <paragraph num="(1)"> <text>A full-time or part-time licensed social worker, who has at least 1 year of experience providing services to adults in a health care setting; and</text> </paragraph> <paragraph num="(2)"> <text>A full-time, part-time, or contractual medical director who:</text> <paragraph num="(a)"> <text>Has 1 year of experience in the care of impaired adults; and</text> </paragraph> <paragraph num="(b)"> <text>May function as the primary care provider for those participants who do not have a primary care provider, consult with staff regarding a participant’s condition and medical needs, and assist with the development of the medical day care center’s health care policies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The medical day care center is required under COMAR 10.12.04 to have a director who has a bachelor's degree or is a registered nurse. When the director is not a registered nurse, the center shall designate a health director who is a registered nurse. The health director shall:</text> <paragraph num="(1)"> <text>Establish, develop, and amend the center's health care policies and procedures;</text> </paragraph> <paragraph num="(2)"> <text>Supervise health care services;</text> </paragraph> <paragraph num="(3)"> <text>Manage the delivery of all required health care services to ensure that needed services are provided in a timely manner by appropriate personnel consistent with each individual's plan of care; and</text> </paragraph> <paragraph num="(4)"> <text>Consult with other health care providers to coordinate care, services, and referrals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>The Program reimburses for a day of care which includes the following services:</text> <paragraph num="(1)"> <text>Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following:</text> <paragraph num="(a)"> <text>Participation in the development of the individual participant's plan of care;</text> </paragraph> <paragraph num="(b)"> <text>Participation in the determination of the participant's medical, psychosocial, and functional status;</text> </paragraph> <paragraph num="(c)"> <text>Consultation with the participant’s primary care provider; and</text> </paragraph> <paragraph num="(d)"> <text>Consultation with staff regarding a participant's condition and health care needs;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include:</text> <paragraph num="(a)"> <text>The evaluation of the needs of the participants for nursing care;</text> </paragraph> <paragraph num="(b)"> <text>The supervision of any nursing staff;</text> </paragraph> <paragraph num="(c)"> <text>Preventive and maintenance services;</text> </paragraph> <paragraph num="(d)"> <text>Observation and monitoring of participant's condition;</text> </paragraph> <paragraph num="(e)"> <text>Rehabilitative services;</text> </paragraph> <paragraph num="(f)"> <text>The teaching and training activities in appropriate self-care techniques;</text> </paragraph> <paragraph num="(g)"> <text>The supervision of medication normally self-administered;</text> </paragraph> <paragraph num="(h)"> <text>The provision of health education;</text> </paragraph> <paragraph num="(i)"> <text>Discharge planning; and</text> </paragraph> <paragraph num="(j)"> <text>Nursing services that may be delegated to other staff in accordance with the Maryland Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physical therapy services, performed by or under supervision of a licensed physical therapist, which meet the following conditions:</text> <paragraph num="(a)"> <text>Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided with the expectation based on the assessment made by the primary care provider, that a participant will improve significantly in a reasonable and generally predictable period of time, or are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state;</text> </paragraph> <paragraph num="(b)"> <text>Are directly related to the primary care provider’s written plan of care which specifies:</text> <paragraph num="(i)"> <text>Part or parts to be treated;</text> </paragraph> <paragraph num="(ii)"> <text>Type of modalities or treatments to be rendered;</text> </paragraph> <paragraph num="(iii)"> <text>Expected results of physical therapy treatments;</text> </paragraph> <paragraph num="(iv)"> <text>Frequency and duration of treatment;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The complexity and sophistication of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed physical therapist; and</text> </paragraph> <paragraph num="(d)"> <text>The services are considered within accepted standards of medical practice to be a specified and effective treatment for a participant's condition;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Occupational therapy services, performed by an occupational therapist, that meet the following conditions:</text> <paragraph num="(a)"> <text>The treatment requires the special skills of an occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>The services are directly related to the primary care provider’s written plan of care which specifies the treatment to be rendered, the frequency and duration of treatment, and the expected results of treatment;</text> </paragraph> <paragraph num="(c)"> <text>The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and</text> </paragraph> <paragraph num="(d)"> <text>The services fall within one or more of the following categories:</text> <paragraph num="(i)"> <text>Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests;</text> </paragraph> <paragraph num="(ii)"> <text>Selection and teaching of task-oriented therapeutic activities designed to restore physical function;</text> </paragraph> <paragraph num="(iii)"> <text>Teaching of compensatory techniques to improve the level of independence in the activities of daily living;</text> </paragraph> <paragraph num="(iv)"> <text>Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and</text> </paragraph> <paragraph num="(v)"> <text>Improvement of mobility skills;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Personal care services which include assistance with activities of daily living such as:</text> <paragraph num="(a)"> <text>Bathing;</text> </paragraph> <paragraph num="(b)"> <text>Eating;</text> </paragraph> <paragraph num="(c)"> <text>Toileting;</text> </paragraph> <paragraph num="(d)"> <text>Dressing; and</text> </paragraph> <paragraph num="(e)"> <text>Ambulation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Nutrition services which include the following:</text> <paragraph num="(a)"> <text>Meals and snacks as specified under COMAR 10.12.04.20;</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic diets as specified under COMAR 10.12.04.20; and</text> </paragraph> <paragraph num="(c)"> <text>Dietary counseling and education;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Social work services performed by a licensed, certified social worker or licensed social work associate which include:</text> <paragraph num="(a)"> <text>Screening and interviewing or assisting designated staff with screening and interviewing all referrals to determine the general appropriateness of the prospective participant for the full assessment process and medical day care participation;</text> </paragraph> <paragraph num="(b)"> <text>Ongoing services to include:</text> <paragraph num="(i)"> <text>Identifying the emotional and social needs of participants during the rendering of medical day care services;</text> </paragraph> <paragraph num="(ii)"> <text>Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers;</text> </paragraph> <paragraph num="(iii)"> <text>Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders;</text> </paragraph> <paragraph num="(iv)"> <text>Counseling a participant and a participant's family in the availability and utilization of public and private community agency services, referral to, and coordination of these services;</text> </paragraph> <paragraph num="(v)"> <text>Assisting participants in obtaining those health care services which are not available through the medical day care center (such as vision care, podiatry, medical equipment, etc.);</text> </paragraph> <paragraph num="(vi)"> <text>Counseling participants individually to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care;</text> </paragraph> <paragraph num="(vii)"> <text>Coordinating and implementing group and family counseling in conjunction with plan of care goals;</text> </paragraph> <paragraph num="(viii)"> <text>Writing notes in the participant’s records that reflect the social work activities performed;</text> </paragraph> <paragraph num="(ix)"> <text>Participating in the multidisciplinary team meetings; and</text> </paragraph> <paragraph num="(x)"> <text>Assisting participants with completing the Community Settings Questionnaire; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Discharge planning and referral services including:</text> <paragraph num="(i)"> <text>Written procedures for discharge, referral, and follow-up;</text> </paragraph> <paragraph num="(ii)"> <text>A discharge summary with post discharge goals;</text> </paragraph> <paragraph num="(iii)"> <text>Recommendations for continuing care; and</text> </paragraph> <paragraph num="(iv)"> <text>Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Activity programs in accordance with COMAR 10.12.04.15C; and</text> </paragraph> <paragraph num="(9)"> <text>Transportation services that:</text> <paragraph num="(a)"> <text>Are in accordance with COMAR 10.12.04.27;</text> </paragraph> <paragraph num="(b)"> <text>Are provided or arranged for a participant by the medical day care staff;</text> </paragraph> <paragraph num="(c)"> <text>Maximize the following types of transportation services in an effort to achieve the least costly, yet appropriate means of transportation for a participant:</text> <paragraph num="(i)"> <text>Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile;</text> </paragraph> <paragraph num="(ii)"> <text>Family-supplied transportation provided by friends, neighbors, or volunteers; and</text> </paragraph> <paragraph num="(iii)"> <text>Public transportation services;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Are procured by the provider after options described in §A(10)(b) of this regulation have been exhausted;</text> </paragraph> <paragraph num="(e)"> <text>Are the responsibility of the provider to:</text> <paragraph num="(i)"> <text>Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and</text> </paragraph> <paragraph num="(ii)"> <text>Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Are provided in accordance with records that clearly indicate both a primary transportation plan and a back-up plan;</text> </paragraph> <paragraph num="(g)"> <text>Are documented, indicating the type of transportation used by each participant;</text> </paragraph> <paragraph num="(h)"> <text>Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and</text> </paragraph> <paragraph num="(i)"> <text>Are included in the day of care for:</text> <paragraph num="(i)"> <text>Trips and outings which are part of the activities program; and</text> </paragraph> <paragraph num="(ii)"> <text>A participant's medical appointment escorted by center staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall reimburse for a day of care when this care is:</text> <paragraph num="(1)"> <text>Authorized in the participant's waiver service plan;</text> </paragraph> <paragraph num="(2)"> <text>Medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care;</text> </paragraph> <paragraph num="(4)"> <text>Provided to a participant certified annually by the Department as requiring nursing facility care as specified under COMAR 10.09.10; and</text> </paragraph> <paragraph num="(5)"> <text>Provided to participants certified present at the medical day care center a minimum of 4 hours a day by an adequately maintained and documented participant register.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <paragraph num="A."> <text>Medical day care services are not covered for:</text> <paragraph num="(1)"> <text>Individuals who do not meet the definition of “participant” in Regulation .01B of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Individuals younger than 16 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Covered services do not include:</text> <paragraph num="(1)"> <text>Days of service in excess of the frequency specified in the participant’s home and community based services waiver service plan;</text> </paragraph> <paragraph num="(2)"> <text>Services which are not part of those services listed in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Services for a number of participants that exceeds the provider’s licensed capacity on a given day;</text> </paragraph> <paragraph num="(4)"> <text>More than one day of care, per participant, per day; and</text> </paragraph> <paragraph num="(5)"> <text>A day of care provided on the same day that the following services are provided and billed to the Department:</text> <paragraph num="(a)"> <text>Day habilitation services under COMAR 10.09.26;</text> </paragraph> <paragraph num="(b)"> <text>Supported employment services under COMAR 10.09.26;</text> </paragraph> <paragraph num="(c)"> <text>Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44;</text> </paragraph> <paragraph num="(d)"> <text>Senior center plus services under COMAR 10.09.54;</text> </paragraph> <paragraph num="(e)"> <text>Adult day care reimbursed under the State of Maryland's human service contracts; or</text> </paragraph> <paragraph num="(f)"> <text>On-site psychiatric rehabilitation services under COMAR 10.09.59.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Authorization Requirements."> <text>The provider is entitled to reimbursement from the Program when:</text> <paragraph num="A."> <text>The participant is enrolled in a home and community based services waiver; and</text> </paragraph> <paragraph num="B."> <text>The service is specified in the participant’s home and community based services waiver service plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment Procedures."> <paragraph num="A."> <text>Requests for Payment.</text> <paragraph num="(1)"> <text>All requests for payment of services rendered shall be submitted in accordance with COMAR 10.09.36.</text> </paragraph> <paragraph num="(2)"> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Payment to a provider shall be limited to the number of days each participant attends the medical day care center, as authorized by a participant’s home and community based services waiver service plan.</text> </paragraph> <paragraph num="C."> <text>Payment shall be made only to a qualified medical day care provider. Payment may not be made to a participant, or to individual nurses, physicians, social workers, activity coordinators, or aides for services rendered in connection with the provision of medical day care.</text> </paragraph> <paragraph num="D."> <text>Per Diem Rate.</text> <paragraph num="(1)"> <text>Payment to a medical day care services provider shall be as follows:</text> <paragraph num="(a)"> <text>For dates of service from January 1, 2021 through October 31, 2021, $88.95 per diem;</text> </paragraph> <paragraph num="(b)"> <text>For dates of service from November 1, 2021 through June 30, 2022, $93.58 per diem;</text> </paragraph> <paragraph num="(c)"> <text>For dates of service [on or after] from July 1, 2022 through December 31, 2023, $104.81 per diem;</text> </paragraph> <paragraph num="(d)"> <text>For dates of service from January 1, 2024 through June 30, 2024, $113.19 per diem; and</text> </paragraph> <paragraph num="(e)"> <text>For dates of service on or after July 1, 2024, $116.59 per diem.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Subject to the limitations of the State budget, the per diem rate shall increase on July 1 of each year by 4 percent.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment to a provider of medical day care services may not exceed the lesser of the:</text> <paragraph num="(1)"> <text>Per diem rate established under §D of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Provider's customary charge to the general public for services covered by the Program, unless the service is free to individuals not covered by Medicaid.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be in accordance with COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Appeal Procedures."> <text>Appeal procedures shall be in accordance with COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in accordance with COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-111, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1980 (6:26 Md. R. 2073)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B, C and .07D amended effective March 10, 1986 (13:5 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted and .07A amended effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective June 3, 1985 (12:11 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective July 1, 1983 (10:12 Md. R. 1070); adopted permanently effective September 12, 1983 (10:18 Md. R. 1608)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 1, 1989 (16:8 Md. R. 909)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and 07A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03J and K and .09 amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); adopted permanently effective November 1, 1990 (17:21 Md. R. 2529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective July 4, 1994 (21:13 Md. R. 1157); November 24, 2003 (30:23 Md. R. 1651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1 adopted as an emergency provision effective February 1, 2002 (29:4 Md. R. 412); emergency status expired June 30, 2002</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 14, 2008 (35:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, I amended effective May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, M amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03M amended effective April 4, 2011 (38:7 Md. R. 431); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 22, 2010 (37:4 Md. R. 340); April 4, 2011 (38:7 Md. R. 431); May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 10, 2016 (43:20 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective April 6, 2009 (36:7 Md. R. 523); February 22, 2010 (37:4 Md. R. 340); October 31, 2011 (38:22 Md. R. 1345); May 20, 2019 (46:10 Md. R. 486); May 18, 2020 (47:10 Md. R. 516); November 14, 2022 (49:23 Md. R. 995); October 16, 2023 (50:20 Md. R. 886); November 24, 2025 (Md. R. 52:23 1138)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-1 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired August 22, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> </annotations> </chapter> <chapter num="08" heading="Freestanding Clinics"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“All-inclusive cost-per-visit rate” means the rate that is established for Federally Qualified Health Centers (FQHCs) which includes all services that are rendered to a participant on a given date of service.</text> </paragraph> <paragraph num="(2)"> <text>“Clinic services” means preventive, diagnostic, therapeutic, rehabilitative or palliative items or services furnished by or under the direction of a licensed physician or dentist either in a freestanding clinic, or outside the clinic if the:</text> <paragraph num="(a)"> <text>Participant does not reside in a permanent dwelling or have a fixed home or mailing address; and</text> </paragraph> <paragraph num="(b)"> <text>Service is provided by clinic personnel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means that a physician is:</text> <paragraph num="(a)"> <text>Physically present in the same area of a facility as a nonphysician providing the services required in the physician's plan of care unless standing orders and protocols are provided for physician extenders such as nurse practitioners, nurse midwives, and physician assistants; and</text> </paragraph> <paragraph num="(b)"> <text>Readily available for consultation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq. (1981), and COMAR 10.09.23 for assessing growth and development and for detecting and treating health problems in Medical Assistance enrollees younger than 21 years old.</text> </paragraph> <paragraph num="(7)"> <text>“Extraordinary one-time circumstance” means a highly unusual event beyond the control of a federally qualified health center (FQHC), such as an earthquake or flood, which results in an increase in the FQHC's operating costs.</text> </paragraph> <paragraph num="(8)"> <text>Freestanding Clinic.</text> <paragraph num="(a)"> <text>“Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services.</text> </paragraph> <paragraph num="(b)"> <text>“Freestanding clinic” does not include a clinic or clinic site located in a participant’s home.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Home.</text> <paragraph num="(a)"> <text>“Home” means the house, apartment, trailer, licensed health care facility, or other dwelling in which a participant resides.</text> </paragraph> <paragraph num="(b)"> <text>“Home” does not include dedicated commercial space in a high-rise apartment building.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Hospital” means an institution which:</text> <paragraph num="(a)"> <text>Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Mental health services” means those services described in COMAR 10.67.08.02 that are rendered to treat an individual for a diagnosis as set forth in COMAR 10.67.08.02M and N.</text> </paragraph> <paragraph num="(13)"> <text>“Out-stationed eligibility worker” means an employee of a federally qualified health center who is responsible for the receipt and initial processing of applications for Medical Assistance for pregnant women, and children born after September 30, 1983, who are younger than 19 years old in accordance with 42 CFR 435.904.</text> </paragraph> <paragraph num="(14)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(15)"> <text>“Patient care policies” means written policies and protocols, describing patient care practices and procedures:</text> <paragraph num="(a)"> <text>Established for the clinic's operation by a group of professional personnel, including one or more physicians affiliated with the freestanding clinic; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the signature of the clinic's medical director.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Plan of care” means a written plan for the evaluation, treatment, and follow-up of each patient, maintained in the individual's medical record and containing, at a minimum, the following information where applicable:</text> <paragraph num="(a)"> <text>Patient identification data, dates of service, and medical history;</text> </paragraph> <paragraph num="(b)"> <text>Chief complaint, physical findings, and presumptive diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Plan of treatment;</text> </paragraph> <paragraph num="(d)"> <text>Results of all laboratory tests and diagnostic radiology procedures ordered and performed;</text> </paragraph> <paragraph num="(e)"> <text>Referral to consultant specialist and consultants report;</text> </paragraph> <paragraph num="(f)"> <text>Medications administered and prescribed, with notations indicating quantity, strength, dosage, and refill instructions; and</text> </paragraph> <paragraph num="(g)"> <text>Final diagnoses, other therapy ordered, and follow-up plan.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Preauthorization” means the approval required from the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(18)"> <text>“Primary care services” means those medical care services which address a patient's general health needs, including the coordination of the individual's health care with the responsibility for the:</text> <paragraph num="(a)"> <text>Prevention of disease;</text> </paragraph> <paragraph num="(b)"> <text>Promotion and maintenance of health;</text> </paragraph> <paragraph num="(c)"> <text>Treatment of illness; and</text> </paragraph> <paragraph num="(d)"> <text>When appropriate, referral to other specialists for more intensive care.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(20)"> <text>“Provider” means a freestanding clinic which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(21)"> <text>“Qualified provider” means an individual that meets the definition of a qualified provider under Health-General Article, §§20-103(a) and 20-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Rural health clinic” means a facility that meets the definition of a rural health clinic as contained in 42 CFR §491.2(f).</text> </paragraph> <paragraph num="(23)"> <text>“Scope of services change” means a permanent and substantial change in the services or practices of a FQHC that results from one or more of the following:</text> <paragraph num="(a)"> <text>The addition or deletion of a Medicaid-covered FQHC service as described in §1905(a)(2)(B) and (C) of the federal Social Security Act;</text> </paragraph> <paragraph num="(b)"> <text>The addition, elimination, expansion, or reduction of a Health Resources and Service Administration (HRSA) approved FQHC practice location; or</text> </paragraph> <paragraph num="(c)"> <text>A change in costs for out-stationed eligibility worker services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A physician or osteopath providing services in a freestanding clinic shall be licensed and legally authorized to practice medicine in the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall ensure that all X-ray and other radiological equipment:</text> <paragraph num="(1)"> <text>Is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the standards established by COMAR 26.12.01—26.12.03, or other applicable standards established by the state in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall ensure that a Clinical Laboratory Improvement Amendment (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.06; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>When applicable, abortion clinics shall be licensed in accordance with COMAR 10.12.01.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a freestanding clinic provider require that the provider:</text> <paragraph num="(1)"> <text>Meet the applicable standards and requirements of Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Verify the licenses and credentials of all professionals employed by or under contract with the freestanding clinic to provide services;</text> </paragraph> <paragraph num="(3)"> <text>Have clearly defined, written, patient care policies;</text> </paragraph> <paragraph num="(4)"> <text>Maintain adequate documentation of each contact with each participant as part of the plan of care, which, at a minimum, shall include:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant’s chief medical complaint or reason for visit;</text> </paragraph> <paragraph num="(c)"> <text>A brief description of the physical findings and the service provided, including procedures and progress notes; and</text> </paragraph> <paragraph num="(d)"> <text>A legible signature and printed or typed name of professional providing care, with the appropriate title;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have written, effective procedures for infection control under COMAR 10.06.01 Communicable Diseases;</text> </paragraph> <paragraph num="(6)"> <text>Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the freestanding clinic services are provided in accordance with this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Be approved by the Medicaid program in the state in which the service is provided; and</text> </paragraph> <paragraph num="(8)"> <text>Provide for in-house program evaluation and clinical record review which assess use of services for appropriateness in meeting client's needs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In the absence of specifically applicable regulations, a freestanding clinic shall:</text> <paragraph num="(1)"> <text>Comply with §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Comply with specific conditions, which may be included in the written agreement; and</text> </paragraph> <paragraph num="(3)"> <text>Accept reimbursement according to COMAR 10.09.02 Physicians’ Services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Abortion clinics shall provide services in accordance with Health-General Article, §20-209, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in §§B—E of this regulation according to the conditions and requirements indicated.</text> </paragraph> <paragraph num="B."> <text>Medically Necessary Services. The program covers medically necessary services as described in §§C, D, and E of this regulation and in Regulation .05 of this chapter, rendered to participants by a freestanding clinic, when these services are performed by a physician or by:</text> <paragraph num="(1)"> <text>A registered nurse, a psychologist, or a social worker, provided that the individual performs the service within the scope of the individual’s license or certification for the purpose of assisting in the provision of physicians’ services;</text> </paragraph> <paragraph num="(2)"> <text>A nurse midwife, a nurse practitioner, a licensed practical nurse, or a registered physician’s assistant, provided that the individual performs the services within the scope of the individual's license or certification; or</text> </paragraph> <paragraph num="(3)"> <text>An addictions counselor who meets the requirements in accordance with COMAR 10.58.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Family Planning Clinic Services.</text> <paragraph num="(1)"> <text>To participate in the Program as a family planning clinic, a provider shall meet the requirements of Regulation .03 of this chapter and §§B and C(2) of this regulation and shall:</text> <paragraph num="(a)"> <text>Participate in the Title X: National Family Planning Program; or</text> </paragraph> <paragraph num="(b)"> <text>Provide documented evidence of adherence to and compliance with standards established for family planning by the State of Maryland, Planned Parenthood, or the American College of Obstetricians and Gynecologists.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Covered services include:</text> <paragraph num="(a)"> <text>Complete initial and annual physical examination including auscultation of heart and lungs for all patients;</text> </paragraph> <paragraph num="(b)"> <text>Pelvic examination, including bimanual and speculum, and Pap smears on all females annually, unless clinical indication for more frequent examination exists;</text> </paragraph> <paragraph num="(c)"> <text>Laboratory tests including, but not limited to:</text> <paragraph num="(i)"> <text>Hemoglobin or hematocrit, or both, for all patients;</text> </paragraph> <paragraph num="(ii)"> <text>Urinalysis for albumin sugar for all patients;</text> </paragraph> <paragraph num="(iii)"> <text>Sexually transmitted disease (STD) testing for all patients;</text> </paragraph> <paragraph num="(iv)"> <text>Pregnancy testing if indicated by physical examination or history, or both;</text> </paragraph> <paragraph num="(v)"> <text>Rubella titer of all females without documentation of prior rubella immunization which may be done by documented referral to a known provider of this service;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Contraceptive methods and devices approved by the Federal Drug Administration, their insertion, filling, or removal, and education on proper use;</text> </paragraph> <paragraph num="(e)"> <text>Rectal examination, if indicated;</text> </paragraph> <paragraph num="(f)"> <text>Basic education regarding human sexuality and reproduction, for all patients;</text> </paragraph> <paragraph num="(g)"> <text>Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each method and untoward effects and potential complications of each method when performed according to §B of this regulation;</text> </paragraph> <paragraph num="(h)"> <text>Sperm count and analysis done on premises or by appropriate documented referral;</text> </paragraph> <paragraph num="(i)"> <text>Sterilizations, including vasectomy, when coded as family planning and when the appropriate forms, as established by Program guidelines, are properly completed and attached to the claim;</text> </paragraph> <paragraph num="(j)"> <text>Post-vasectomy follow-up; and</text> </paragraph> <paragraph num="(k)"> <text>Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Abortion Clinic Care.</text> <paragraph num="(1)"> <text>To participate in the Program as an abortion clinic, the provider shall meet the requirements of Regulations .02 and .03 of this chapter and §B of this regulation and shall:</text> <paragraph num="(a)"> <text>Meet all applicable state and local requirements for licensure and certification in the state or jurisdiction in which the clinic is located; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure abortions are performed by a qualified provider and in compliance with all applicable Program regulations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Covered services shall include:</text> <paragraph num="(a)"> <text>An abortion procedure for pregnancies which shall include a pelvic examination, and preoperative and postoperative care;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory tests to include pregnancy test, urinalysis for sugar and albumin, hemoglobin or hematocrit, or both, and Rh factor typing;</text> </paragraph> <paragraph num="(c)"> <text>Pap smear;</text> </paragraph> <paragraph num="(d)"> <text>Anesthesia or sedatives or analgesics or any combination of these drugs;</text> </paragraph> <paragraph num="(e)"> <text>Referral to family planning clinic for follow-up family planning;</text> </paragraph> <paragraph num="(f)"> <text>Gross and microscopic tissue examination if there is any doubt in the proper identification of the extracted product of conception concerning composition or completeness; and</text> </paragraph> <paragraph num="(g)"> <text>Obstetrical pelvic ultrasound.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Rural Health Clinic Services.</text> <paragraph num="(1)"> <text>To participate as a rural health center, the provider shall:</text> <paragraph num="(a)"> <text>Meet the requirements of Regulations .03 and .05A of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Be federally certified in accordance with 42 CFR Part 491, Subpart A.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Covered services include rural health clinic services as defined in 42 CFR §440.20.</text> </paragraph> <paragraph num="(3)"> <text>The provider shall follow the general rural health center rules and regulations in accordance with 42 CFR §405.2400—42 CFR §405.2417.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Federally Qualified Health Center Services."> <paragraph num="A."> <text>To participate as a federally qualified health center, the provider shall meet the requirements of Regulations .03 and .04B of this chapter and shall:</text> <paragraph num="(1)"> <text>Meet the conditions for coverage in accordance with 42 CFR §491, Subpart A;</text> </paragraph> <paragraph num="(2)"> <text>Be enrolled in the EPSDT/Healthy Kids Program as provided in COMAR 10.09.23 and provide EPSDT/Healthy Kids services to participants who are eligible to receive them;</text> </paragraph> <paragraph num="(3)"> <text>Supply the Department with financial and other information as requested;</text> </paragraph> <paragraph num="(4)"> <text>Meet one of the following conditions:</text> <paragraph num="(a)"> <text>Meet all of the requirements for receiving a grant under §329, 330, or 340 of the Public Health Service Act, 42 U.S.C. §254(c), as determined by the Secretary of the United States Department of Health, and in accordance with 42 CFR §405.2401;</text> </paragraph> <paragraph num="(b)"> <text>Receive a waiver from the Secretary of the United States Department of Health and Human Services of one or more of the requirements for receiving a grant pursuant to §329, 330, or 340 of the Public Health Service Act; or</text> </paragraph> <paragraph num="(c)"> <text>Be an outpatient health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act or by an Urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Comply with the requirements contained in COMAR 10.09.59 if delivering mental health services and COMAR 10.09.80 when providing substance use disorder services; and</text> </paragraph> <paragraph num="(6)"> <text>Comply with the requirements contained in COMAR 10.09.05, if rendering dental services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Covered services are the same as those authorized to be provided by rural health clinics as described in 42 CFR §440.20(b), rural health clinic services, and 42 CFR §440.20(c), other ambulatory services furnished by a rural health clinic.</text> </paragraph> <paragraph num="C."> <text>In the event that the provider elects to institute a scope of services change, the provider shall:</text> <paragraph num="(1)"> <text>Notify the Department of its intent to institute the scope of services change:</text> <paragraph num="(a)"> <text>Not later than 30 days before it begins to deliver services under the scope of services change; or</text> </paragraph> <paragraph num="(b)"> <text>Within 30 days after the adoption of this section; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide the Department with any information the Department needs to:</text> <paragraph num="(a)"> <text>Assure continuity of care for enrollees;</text> </paragraph> <paragraph num="(b)"> <text>Arrange for the processing and payment of claims; or</text> </paragraph> <paragraph num="(c)"> <text>Otherwise administer services to Medical Assistance participants under the provider's scope of services change.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Rate Revisions for FQHCs Due to Scope of Services Change or Extraordinary One-Time Circumstance.</text> <paragraph num="(1)"> <text>If an FQHC implements a change in the FQHCs scope of services or if the FQHC experiences an extraordinary one-time circumstance, the FQHC or the Department may request a revision of the FQHC's prospective rate of reimbursement.</text> </paragraph> <paragraph num="(2)"> <text>The FQHC shall provide the Department with written notification no later than 30 days after the implementation of the scope of services change or the occurrence of the one-time circumstance.</text> </paragraph> <paragraph num="(3)"> <text>After receiving notification from an FQHC that the FQHC plans to institute a scope of services change, the Department shall notify the FQHC within 30 days if the Department wishes to request a revision to an FQHC's rate.</text> </paragraph> <paragraph num="(4)"> <text>An FQHC or the Department may not request more than one rate revision per FQHC per calendar year under this regulation.</text> </paragraph> <paragraph num="(5)"> <text>When an FQHC or the Department requests a rate revision based on §D(1) of this regulation, the FQHC shall submit to the Department or its designee a cost report and supporting documentation.</text> </paragraph> <paragraph num="(6)"> <text>The cost report and supporting documentation required under §D(5) of this regulation shall:</text> <paragraph num="(a)"> <text>Be submitted within 90 days after the end of the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance;</text> </paragraph> <paragraph num="(b)"> <text>Reflect the change in costs relating to the rate revision request for the center's operations for the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance;</text> </paragraph> <paragraph num="(c)"> <text>Conform with the standards described in §C of this regulation and instructions issued by the Department or its designee;</text> </paragraph> <paragraph num="(d)"> <text>Contain an explanation of the scope of services change or extraordinary one-time circumstance and schedules to support the calculation of the change in the cost-per-visit rate; and</text> </paragraph> <paragraph num="(e)"> <text>Be subject to verification and adjustment by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Rate revisions granted under this section shall be effective the date the change of scope was approved by the Health Resources and Services Administration (HRSA) or the occurrence of the extraordinary one-time circumstance.</text> </paragraph> <paragraph num="(8)"> <text>The revised rate granted under this section shall be the rate referenced in §A(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Rates of reimbursement established according to this regulation shall be for:</text> <paragraph num="(1)"> <text>Payment of covered services rendered to participants; and</text> </paragraph> <paragraph num="(2)"> <text>Determining supplemental payments under COMAR 10.09.65.21A.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>Procedures solely for cosmetic purposes;</text> </paragraph> <paragraph num="E."> <text>Services denied by Medicare as not medically justified;</text> </paragraph> <paragraph num="F."> <text>Freestanding clinic services for inpatient participants in State-operated facilities serving individuals with intellectual disabilities;</text> </paragraph> <paragraph num="G."> <text>Freestanding clinic services provided to hospital inpatients;</text> </paragraph> <paragraph num="H."> <text>Freestanding clinic visits when patients are referred to hospital outpatient departments or emergency rooms for services ordinarily provided in freestanding clinics covered by this chapter;</text> </paragraph> <paragraph num="I."> <text>Freestanding clinic visits solely for the purpose of one or more of the following:</text> <paragraph num="(1)"> <text>Prescription drugs or collection of laboratory specimens, unless otherwise allowed;</text> </paragraph> <paragraph num="(2)"> <text>Certification or recertification of food supplements;</text> </paragraph> <paragraph num="(3)"> <text>Performing laboratory tests required only for certification or recertification of food supplement programs;</text> </paragraph> <paragraph num="(4)"> <text>Nutritional assessments in the absence of diagnosis of nutritional disorders, unless EPSDT or primary health services are provided at the same time;</text> </paragraph> <paragraph num="(5)"> <text>Ascertaining the patient's weight;</text> </paragraph> <paragraph num="(6)"> <text>Interpretation of laboratory tests or panels; and</text> </paragraph> <paragraph num="(7)"> <text>Measurement of blood pressure;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Office visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the medical record;</text> </paragraph> <paragraph num="K."> <text>More than one visit per day to the same freestanding clinic, unless the additional visit is adequately documented as:</text> <paragraph num="(1)"> <text>An emergency situation; or</text> </paragraph> <paragraph num="(2)"> <text>A visit to a different specialty;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Central nervous system stimulants and anorectic agents when used for weight control;</text> </paragraph> <paragraph num="M."> <text>Immunizations required solely for travel outside the continental United States;</text> </paragraph> <paragraph num="N."> <text>Vision care services excluded under COMAR 10.09.14 or COMAR 10.09.23;</text> </paragraph> <paragraph num="O."> <text>Separate billing for services which are specifically included as part of another service;</text> </paragraph> <paragraph num="P."> <text>Separate reimbursement to a practitioner for services provided in a freestanding clinic in addition to the freestanding clinic reimbursement;</text> </paragraph> <paragraph num="Q."> <text>Payment for more than one visit to complete an EPSDT screening service;</text> </paragraph> <paragraph num="R."> <text>Visits solely for group or individual health education;</text> </paragraph> <paragraph num="S."> <text>Freestanding clinic visits in addition to an EKG procedure when the EKG procedure is the only purpose for the visit; and</text> </paragraph> <paragraph num="T."> <text>Services for which preauthorization is required under Regulation .09 of this chapter but has not been obtained.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Freestanding Clinic Reimbursement Methodology."> <paragraph num="A."> <text>Reimbursement for Family Planning Clinics. The Department shall pay the family planning clinic the lesser of the provider’s customary charge or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with COMAR 10.09.02.07D; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursement for Abortion Clinics. For dates of service on or after April 1, 2015, the Department shall pay the abortion clinic the lesser of the provider’s customary charge, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with COMAR 10.09.02.07D; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursement for Rural Health Clinics. The Department shall reimburse rural health clinics in accordance with 42 CFR §447.371.</text> </paragraph> <paragraph num="D."> <text>The Department shall pay all other freestanding clinics at the lesser of the provider’s customary charge, or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with COMAR 10.09.02.07D; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reimbursement Methodology for FQHC Services."> <paragraph num="A."> <text>Federally qualified health centers shall be reimbursed for covered services once the provider is in compliance with all federal and State requirements.</text> </paragraph> <paragraph num="B."> <text>The only well-child visits that are eligible for Program reimbursement are those that are billed as EPSDT screens.</text> </paragraph> <paragraph num="C."> <text>Payment of Allowable Costs.</text> <paragraph num="(1)"> <text>Federally qualified health centers shall be paid 100 percent of the FQHC’s allowable costs, subject to the limitations contained in §§D—G of this regulation, that are related to the provision of covered services.</text> </paragraph> <paragraph num="(2)"> <text>Allowable costs will be determined in accordance with Medicare principles of cost reimbursement as contained in 42 CFR 413.5, unless otherwise specified in this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Providers' allowable costs are subject to audit and verification by the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>Costs not adequately documented, return on equity, bad debts incurred by private pay, Medicare patients, or third-party payers, and bad debts resulting from denied costs of the Program are not allowable in establishing reimbursement rates.</text> </paragraph> <paragraph num="(5)"> <text>Services covered under §1915(g) of Title XIX of the Social Security Act, which are called targeted case management services, and the costs associated with these services, are excluded when establishing reimbursement rates.</text> </paragraph> </paragraph> <paragraph num="D."> <text>All-Inclusive Cost-per-Visit Rate.</text> <paragraph num="(1)"> <text>Reimbursement to providers of federally qualified health center services shall be on a per-visit basis. The Department or its designee shall establish an all-inclusive interim and an all-inclusive final cost-per-visit rate for each provider.</text> </paragraph> <paragraph num="(2)"> <text>Each provider shall have a rate established for primary care services. A rate for dental care services shall be established if the service is offered.</text> </paragraph> <paragraph num="(3)"> <text>The all-inclusive cost-per-visit rate for primary care visits covers the allowable costs associated with covered primary care, mental health, and substance abuse services. FQHCs may not charge the program, other than an all-inclusive cost-per-visit rate, for any ambulatory service.</text> </paragraph> <paragraph num="(4)"> <text>The all-inclusive cost-per-visit rate for dental care visits covers only those services that are reimbursed by the Program under COMAR 10.09.05. Other dental services are not reimbursable.</text> </paragraph> <paragraph num="(5)"> <text>Providers' costs, except for those of OB/GYN physicians, for staff who provide radiology services, for off-site visits, and for out-stationed eligibility workers, are divided into the following four cost centers:</text> <paragraph num="(a)"> <text>General service cost center is composed of those costs associated with the depreciation of the facility's building or buildings and equipment, the operation of the plant, the administration and management of the facility, medical records, and those administrative costs associated with pharmacy and EPSDT services which are not reimbursed under a different payment methodology;</text> </paragraph> <paragraph num="(b)"> <text>Primary care services costs are composed of those costs, including supplies, associated with health care staff, including laboratory technicians, who provide direct care to patients;</text> </paragraph> <paragraph num="(c)"> <text>Dental services costs are the costs of supplies and health care staff associated with the provision of dental services to patients; and</text> </paragraph> <paragraph num="(d)"> <text>Non-reimbursable costs are those costs that are not reimbursable under this payment methodology.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The interim and final cost-per-visit rates for each service shall be determined by dividing the provider's allowable costs for each service by the total number of visits to the provider for each service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Calculation of the Interim All-Inclusive Cost-per-Visit Rate.</text> <paragraph num="(1)"> <text>An interim all-inclusive cost-per-visit rate shall be established for the first 2 years of operation.</text> </paragraph> <paragraph num="(2)"> <text>Providers shall be divided into those located in urban areas and those located in rural areas. Baltimore City and the Maryland counties of Allegany, Anne Arundel, Baltimore, Carroll, Cecil, Charles, Harford, Howard, Montgomery, Prince George's, St. Mary’s and Wicomico are urban areas.</text> </paragraph> <paragraph num="(3)"> <text>All other Maryland counties are rural areas.</text> </paragraph> <paragraph num="(4)"> <text>Providers located out-of-State shall be placed in the same reimbursement class as that of the nearest Maryland county.</text> </paragraph> <paragraph num="(5)"> <text>An interim all-inclusive cost-per-visit rate shall be established for primary care and for dental care services, if applicable, for each provider, by averaging the current FQHC all-inclusive cost-per-visit rate amounts for each area, urban or rural.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Calculation of the Final All-Inclusive Cost-per-Visit Rate.</text> <paragraph num="(1)"> <text>Following the close of the provider's 2nd fiscal year, the Department or its designee shall determine the final all-inclusive cost-per-visit rate for primary care services and, if offered, for dental care services, for those fiscal years based on the costs stated in the cost report for the 2 fiscal years and subject to the limitations in these regulations.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall submit to the Department or the Department's designee, on the form prescribed, direct and indirect costs and statistical data applicable to patient care.</text> </paragraph> <paragraph num="(3)"> <text>The provider's cost report shall be reviewed in accordance with the standards referenced in §C(1) of this regulation to determine the allowable costs and the number of visits for that cost reporting period.</text> </paragraph> <paragraph num="(4)"> <text>In calculating the final all-inclusive cost-per-visit rates, the limitation on general service cost center costs described in §D(5)(a) of this regulation shall apply.</text> </paragraph> <paragraph num="(5)"> <text>Once the all-inclusive cost-per-visit rate has been determined for each fiscal year, each provider is eligible for additional primary care reimbursement for services rendered by OB/GYN physicians, staff who provide radiology services, off-site visits, and out-stationed eligibility workers. Costs for these additional services are limited to salaries and fringe benefits, including any malpractice insurance, that are paid by the provider. The additional primary care reimbursement shall be calculated by taking the sum of the provider's expenditures for OB/GYN physicians, for staff who provide radiology services, out-stationed eligibility workers, and off-site visits. This sum is divided by the total number of primary care visits. The resulting rate shall be added to the all-inclusive cost-per-visit rate.</text> </paragraph> <paragraph num="(6)"> <text>The final all-inclusive cost-per-visit rate shall be determined by averaging the all-inclusive cost-per-visit rates for the 2 fiscal years and by adding, if applicable, the additional rate for OB/GYN, staff who provide radiology services, or off-site visits.</text> </paragraph> <paragraph num="(7)"> <text>This final all-inclusive cost-per-visit rate shall be implemented retroactively to the start date of the FQHC’s operation.</text> </paragraph> <paragraph num="(8)"> <text>The final all-inclusive rate shall be increased by the Medicare Economic Index (MEI) each calendar year.</text> </paragraph> <paragraph num="(9)"> <text>The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures.</text> </paragraph> <paragraph num="(10)"> <text>The provider shall keep all records available for a period of 6 years subject to inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Cost Reporting.</text> <paragraph num="(1)"> <text>A provider shall submit to the Department or the Department's designee a cost report, and other financial and statistical information requested, within 3 months after the close of the provider's 2nd fiscal year, unless the Department grants the provider an extension or the provider discontinues participation as a federally qualified health center. The following apply:</text> <paragraph num="(a)"> <text>The Program may grant a provider an extension if the provider makes a written request setting forth the specific reasons for the request and the Department determines that the request is reasonable; or</text> </paragraph> <paragraph num="(b)"> <text>If a provider discontinues participation as a federally qualified health center, it shall submit its cost report and other financial and statistical data to the Department within 45 days after the effective date of termination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cost reports are considered to have been received by the Department or the Department's designee when the submitted reports are completed according to the instructions issued by the Department, or the Department's designee.</text> </paragraph> <paragraph num="(3)"> <text>If a provider's cost report has not been received within 3 months after the close of the provider's 2nd fiscal year or within the deadline set by the Department after an extension has been granted, the Department shall reduce the provider's current interim all-inclusive cost-per-visit rate by 20 percent for visits paid during the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. This amount shall be eligible for repayment to the provider upon final cost settlement for the fiscal year or fiscal years from which the payments were withheld.</text> </paragraph> <paragraph num="(4)"> <text>When a provider's cost report is received by the last day of the 6th month after the end of the provider's 2nd fiscal year and the Department or the Department's designee determines that the final all-inclusive cost-per-visit rate is different than the interim all-inclusive cost-per-visit rate, the increase or decrease is applicable to all reimbursable visits retroactively.</text> </paragraph> <paragraph num="(5)"> <text>The Department or its designee shall notify each provider of the results of the verification of the provider's cost report.</text> </paragraph> <paragraph num="(6)"> <text>The provider may appeal the final cost settlement by following the procedures described in COMAR 10.09.36.09.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Calculation and Reimbursement of Number of Visits for FQHC Services Rendered to MCO Enrollees.</text> <paragraph num="(1)"> <text>The FQHC shall transmit all of the encounter data to the appropriate MCO.</text> </paragraph> <paragraph num="(2)"> <text>The MCO shall reimburse the FQHC their established all-inclusive cost-per-visit rate for all eligible visits.</text> </paragraph> <paragraph num="(3)"> <text>The FQHC shall have the responsibility of reconciling the number of eligible visits with the MCOs.</text> </paragraph> <paragraph num="(4)"> <text>Each MCO shall transmit all of its FQHC encounter visits to the Department.</text> </paragraph> <paragraph num="(5)"> <text>For an FQHC, the calculation of the number of MCO enrollee visits is as follows:</text> <paragraph num="(a)"> <text>For each 6-month period thereafter, the number of eligible visits received for each period shall be totaled by the Department 12 months after the end of the period;</text> </paragraph> <paragraph num="(b)"> <text>The number of visits reported in §H(5)(a) of this regulation shall constitute the number of visits on which final payments shall be made to each MCO as reported by each FQHC for that 6-month period;</text> </paragraph> <paragraph num="(c)"> <text>The MCO shall receive an interim supplemental payment once every 3 months (quarterly);</text> </paragraph> <paragraph num="(d)"> <text>The interim supplemental payment shall be modified by a final reconciliation of the number of eligible visits applicable to a previous 6-month period received by the Department within 1 year from the end of the 6-month period; and</text> </paragraph> <paragraph num="(e)"> <text>The final payment made to each MCO according to this regulation is not subject to cost settlement.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The following procedures or services require preauthorization:</text> <paragraph num="(1)"> <text>Vision care according to COMAR 10.09.14.06 and COMAR 10.09.23;</text> </paragraph> <paragraph num="(2)"> <text>Mental health services which shall comply with the requirements of COMAR 10.09.59;</text> </paragraph> <paragraph num="(3)"> <text>Substance use disorder services which shall comply with the requirements of COMAR 10.09.80; and</text> </paragraph> <paragraph num="(4)"> <text>Dental services which shall comply with the requirements of COMAR 10.09.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department or its’ designee shall preauthorize services when the provider submits adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> <paragraph num="C."> <text>Preauthorization is valid only for services rendered or initiated within 60 days of the date preauthorization was issued. The patient shall be an eligible participant at the time the service is rendered.</text> </paragraph> <paragraph num="D."> <text>Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment shall be made for services needing preauthorization from the Program only if authorization for those services has been obtained before the services were rendered.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit a completed request for payment in the format designated by the Department with any required documentation.</text> </paragraph> <paragraph num="B."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly completed with a diagnosis, procedure code, and description of the services provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall bill the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with COMAR 10.09.02.07D; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall authorize payment on Medicare cross-over claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions:</text> <paragraph num="(1)"> <text>A deductible shall be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail;</text> </paragraph> <paragraph num="(4)"> <text>Home visits unless specifically authorized by federal law or regulation;</text> </paragraph> <paragraph num="(5)"> <text>More than one visit to complete an EPSDT screen; and</text> </paragraph> <paragraph num="(6)"> <text>Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Program may not make direct payment to participants.</text> </paragraph> <paragraph num="H."> <text>The Program may not make a separate direct payment to any person employed by or under contract to any freestanding clinic for services provided in a freestanding clinic.</text> </paragraph> <paragraph num="I."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 14, 1981 (8:18 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03A and .04A amended effective November 23, 1981 (8:23 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, F amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1426)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D—H amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1348); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed effective October 1, 1985 (12:19 Md. R. 1849)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted effective October 1, 1985 (12:19 Md. R. 1849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 28, 1990 (17:10 Md. R. 1219)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 28, 1990 (17:10 Md. R. 1219)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended as an emergency provision effective July 1, 1986 (13:13 Md. R. 1473); adopted permanently effective December 1, 1986 (13:19 Md. R. 2120)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended as an emergency provision effective November 1, 1985 (12:23 Md. R. 2214); adopted permanently effective May 6, 1986 (13:3 Md. R. 271)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended as an emergency provision effective September 2, 1986 (13:22 Md. R. 2394); emergency status extended to April 5, 1987 (14:4 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective April 6, 1987 (14:7 Md. R. 830); July 1, 1987 (14:13 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective January 1, 1989 (15:26 Md. R. 2983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective May 28, 1990 (17:10 Md. R. 1219)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective June 26, 2000 (27:12 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective February 1, 1991 (18:7 Md. R. 765); emergency status extended at 18:14 Md. R. 1604 (July 12, 1991); revised permanently effective July 8, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 32); November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .04, .05A, and .08A amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1148); amended permanently effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .05C amended as an emergency provision effective December 23, 1995 (23:2 Md. R. 93); adopted permanently effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 17, 2003 (30:3 Md. R. 179); March 5, 2012 (39:4 Md. R. 336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended as an emergency provision effective April 1, 1992 (19:7 Md. R. 741); amended permanently effective July 1, 1992 (19:12 Md. R. 1135)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1468); amended permanently effective December 1, 1992 (19:23 Md. R. 2041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective October 15, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1992 (20:2 Md. R. 112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective June 26, 2000 (27:12 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective August 4, 2003 (30:15 Md. R. 991)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1B, C amended effective August 15, 2005 (32:16 Md. R. 1392)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Recodified to Regulation .09I)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C adopted effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 5, 2012 (39:4 Md. R. 336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 repealed and new Regulations .01—.14 adopted effective April 1, 2015 (42:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, B, D amended effective July 4, 2016 (43:13 Md. R. 712); February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, F amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended effective October 24, 2016 (43:21 Md. R. 1166); October 16, 2023 (50:20 Md. R. 886)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended effective October 16, 2023 (50:20 Md. R. 886)</annotation> </annotations> </chapter> <chapter num="09" heading="Medical Laboratories"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.36.01 are applicable to this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Authorized practitioner” means a physician, osteopath, dentist, podiatrist, nurse midwife, nurse anesthetist, nurse practitioner, or physician assistant employed by a physician or clinic.</text> </paragraph> <paragraph num="(2)"> <text>Freestanding Clinic.</text> <paragraph num="(a)"> <text>“Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services.</text> </paragraph> <paragraph num="(b)"> <text>“Freestanding clinic” does not include a clinic or clinic site located in a participant’s home.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and which is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(4)"> <text>“Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease.</text> </paragraph> <paragraph num="(5)"> <text>“Order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed.</text> </paragraph> <paragraph num="(6)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(7)"> <text>“Preauthorization” means the approval required from the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(8)"> <text>“Reference laboratory” means a medical laboratory, which is enrolled with the Program as either a provider or a renderer, to which a medical laboratory provider refers specimens from Medical Assistance participants for analysis.</text> </paragraph> <paragraph num="(9)"> <text>“Referring laboratory” means a medical laboratory provider that refers specimens from Medical Assistance participants for analysis.</text> </paragraph> <paragraph num="(10)"> <text>“Special handling” means a circumstance in which specimen collection and pickup are accomplished as independent procedures to be responsive to the medical needs of the participant or to preserve viability or condition of the specimen.</text> </paragraph> <paragraph num="(11)"> <text>“Standing order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services to be supplied over a specific time period, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed.</text> </paragraph> <paragraph num="C."> <text>Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01.</text> </paragraph> <paragraph num="D."> <text>Out-of-State Laboratories.</text> <paragraph num="(1)"> <text>Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met.</text> </paragraph> <paragraph num="(2)"> <text>Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03, except that a signature on the services order specified in COMAR 10.09.36.03A(19) is not required.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a medical laboratory include all of the following:</text> <paragraph num="(1)"> <text>Be in compliance with all applicable license, certification, environmental, legal, and professional requirements to perform the clinical laboratory services offered;</text> </paragraph> <paragraph num="(2)"> <text>Maintain records adequate to substantiate the ordering, performance, and reporting of clinical laboratory services performed or referred;</text> </paragraph> <paragraph num="(3)"> <text>Agree to seek reimbursement from the Program only for services set forth in Regulation .04 of this chapter when provided to eligible participants;</text> </paragraph> <paragraph num="(4)"> <text>Agree to refrain from billing participants for noncovered services set forth in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Agree to abide by all provisions set forth in Regulation .07 of this chapter when seeking reimbursement from the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following services:</text> <paragraph num="A."> <text>Medically necessary laboratory services, when the services are:</text> <paragraph num="(1)"> <text>Rendered to participants in a physician's office, hospital, freestanding clinic, or medical laboratory;</text> </paragraph> <paragraph num="(2)"> <text>Provided according to the laws and regulations of the state and locality in which they are rendered;</text> </paragraph> <paragraph num="(3)"> <text>Rendered pursuant to a properly completed order or standing order;</text> </paragraph> <paragraph num="(4)"> <text>Adequately documented in the provider’s files;</text> </paragraph> <paragraph num="(5)"> <text>Clinical and diagnostic services for which certification by the Centers for Medicare and Medicaid Services (CMS) under CLIA exists, if required; and</text> </paragraph> <paragraph num="(6)"> <text>Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Transportation of specimens by medical laboratories when special handling is required by medical necessity when documentation is supplied to the provider by the authorized ordering practitioner; and</text> </paragraph> <paragraph num="C."> <text>Collection of specimens by venipuncture, capillary puncture, or arterial puncture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The following are not covered:</text> <paragraph num="A."> <text>Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the individual practitioner who ordered the laboratory services;</text> </paragraph> <paragraph num="B."> <text>Services not adequately documented in the participant’s medical records;</text> </paragraph> <paragraph num="C."> <text>Services denied by Medicare as not medically necessary;</text> </paragraph> <paragraph num="D."> <text>Clinical laboratory services, for which certification by HCFA under CLIA is required, when these services are performed by laboratories that are not certified to perform those services;</text> </paragraph> <paragraph num="E."> <text>Procedures that the provider knows or should know are investigational or experimental in nature;</text> </paragraph> <paragraph num="F."> <text>Services included by the Program as part of the charge made by an inpatient facility, hospital outpatient department, freestanding clinic, or other Program-recognized entity;</text> </paragraph> <paragraph num="G."> <text>Medical laboratory services related to autopsies;</text> </paragraph> <paragraph num="H."> <text>Medical laboratory services for which there was insufficient quantity of specimen, improper specimen handling, or other circumstances that would render the results unreliable; and</text> </paragraph> <paragraph num="I."> <text>Laboratory services ordered by an:</text> <paragraph num="(1)"> <text>Individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>Entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>Preauthorization is required for any service identified as needing preauthorization in the current laboratory fee schedule, in accordance with Regulation .07D of this chapter.</text> </paragraph> <paragraph num="B."> <text>The provider shall submit the request for preauthorization according to the procedures established by, and in the form designated by, the Department.</text> </paragraph> <paragraph num="C."> <text>Preauthorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met; and</text> </paragraph> <paragraph num="(2)"> <text>The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Preauthorization is valid for services rendered or initiated within 90 days of the date issued.</text> </paragraph> <paragraph num="E."> <text>Preauthorization for Services Billed to Medicare.</text> <paragraph num="(1)"> <text>If Medicare covers and approves a service for which preauthorization by the Program is normally required, the Program shall waive preauthorization requirements for that service.</text> </paragraph> <paragraph num="(2)"> <text>If Medicare rejects the entire claim or any part of a claim for a service that normally requires preauthorization, and the claim is referred to the Program for payment, the Program shall pay only for the Medicare-rejected covered services if authorization for those services was obtained prior to the date of service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Medical laboratory providers shall identify the individual who ordered the laboratory services by recording the individual practitioners National Provider Identifier (NPI) number on the claim.</text> </paragraph> <paragraph num="C."> <text>Unless the service is free to individuals not covered by Medicaid, the provider shall charge the Program the lesser of:</text> <paragraph num="(1)"> <text>The providers customary charge to the general public; or</text> </paragraph> <paragraph num="(2)"> <text>The providers customary charge to other third-party payers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Providers are reimbursed according to the 2022 Medical Laboratory Fee Schedule (Effective March 2022). All the provisions of this document are incorporated by reference.</text> </paragraph> <paragraph num="E."> <text>The Department will pay for covered services the amount that is the lower of the following:</text> <paragraph num="(1)"> <text>Provider's charge according to §C of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Departments maximum rates according to §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines; and</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Supplemental payment on Medicare claims is made subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but covered by the Program, will be paid according to §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The provider may not bill the Department for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(3)"> <text>Services listed in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="J."> <text>When seeking reimbursement for medical laboratory services which are subjected to panel billing regulations or are part of a panel, the medical laboratory provider shall bill the Department the panel rate or the sum of the charges of the individual tests, whichever is less.</text> </paragraph> <paragraph num="K."> <text>A referring laboratory provider may bill the Program for laboratory services performed by a reference laboratory when the:</text> <paragraph num="(1)"> <text>Reference laboratory is:</text> <paragraph num="(a)"> <text>Enrolled with the Program as either a medical laboratory provider or a renderer; and</text> </paragraph> <paragraph num="(b)"> <text>CLIA certified for the procedures performed;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Procedures which were referred, and the identity of the reference laboratory, are identified on the invoice; and</text> </paragraph> <paragraph num="(3)"> <text>Referring laboratory charges not more than the amount it actually paid the reference laboratory.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Standing orders shall:</text> <paragraph num="(1)"> <text>Conform to the specifications for orders found in Regulations .01 and .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Include:</text> <paragraph num="(a)"> <text>A date which shall become the starting date of the order unless another starting date is specified on the order; and</text> </paragraph> <paragraph num="(b)"> <text>Specific instructions outlining the schedule of services to be provided pursuant to the order; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be effective for a maximum of 90 days or, for dialysis patients, be effective for a maximum of 1 year.</text> </paragraph> </paragraph> <paragraph num="M."> <text>All indices, calculated values, or other results that are not directly determined, are considered part of the parent procedures and are not separately billable to either the Program or the participant.</text> </paragraph> <paragraph num="N."> <text>Only those panels or profiles that have a composition specified by CPT or the Program are reimbursable as panels or profiles by the Program. Reimbursement for these recognized panels or profiles is not authorized unless each and every component of the panel or profile is performed.</text> </paragraph> <paragraph num="O."> <text>Two or more of the following chemistry tests shall be reimbursed at a rate that is the lesser of the provider's lowest charge to the general public or third-party payers, or the Program's maximum reimbursement for these chemistry tests when performed as panels:</text> <paragraph num="(1)"> <text>Albumin, serum;</text> </paragraph> <paragraph num="(2)"> <text>Bilirubin, direct;</text> </paragraph> <paragraph num="(3)"> <text>Bilirubin, total;</text> </paragraph> <paragraph num="(4)"> <text>Calcium, total;</text> </paragraph> <paragraph num="(5)"> <text>Carbon dioxide (bicarbonate);</text> </paragraph> <paragraph num="(6)"> <text>Chloride, blood;</text> </paragraph> <paragraph num="(7)"> <text>Cholesterol, serum, total;</text> </paragraph> <paragraph num="(8)"> <text>Creatine kinase (CK), (CPK), total;</text> </paragraph> <paragraph num="(9)"> <text>Creatinine, blood;</text> </paragraph> <paragraph num="(10)"> <text>Glucose, quantitative;</text> </paragraph> <paragraph num="(11)"> <text>Glutamyltransferase, gamma (GGT);</text> </paragraph> <paragraph num="(12)"> <text>Lactate dehydrogenase (LD), (LDH);</text> </paragraph> <paragraph num="(13)"> <text>Phosphatase, alkaline;</text> </paragraph> <paragraph num="(14)"> <text>Phosphorus, inorganic;</text> </paragraph> <paragraph num="(15)"> <text>Potassium, serum;</text> </paragraph> <paragraph num="(16)"> <text>Protein, total, except refractometry;</text> </paragraph> <paragraph num="(17)"> <text>Protein, total, refractometric;</text> </paragraph> <paragraph num="(18)"> <text>Sodium, serum;</text> </paragraph> <paragraph num="(19)"> <text>Transferase, aspartate amino (AST) (SGOT);</text> </paragraph> <paragraph num="(20)"> <text>Transferase, alanine amino (ALT) (SGPT);</text> </paragraph> <paragraph num="(21)"> <text>Triglycerides;</text> </paragraph> <paragraph num="(22)"> <text>Urea nitrogen, quantitative (BUN); and</text> </paragraph> <paragraph num="(23)"> <text>Uric acid, blood.</text> </paragraph> </paragraph> <paragraph num="P."> <text>All of the tests listed in §O of this regulation that are ordered on or performed on the same specimen shall be billed as if performed simultaneously.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>General policies for recovery and reimbursement that are applicable to all providers are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 31, 1977 (4:18 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A repealed effective September 21, 1979 (6:19 Md. R. 1518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective December 15, 1978 (5:25 Md. R. 1854); August 22, 1988 (15:17 Md. R. 2049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective July 11, 1988 (15:14 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A and D amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B repealed effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 15, 1978 (5:25 Md. R. 1854); February 15, 1982 (9:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective December 6, 1982 (9:24 Md. R. 2390); November 21, 1983 (10:23 Md. R. 2063); May 27, 1984 (11:10 Md. R. 863); March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542); June 2, 1986 (13:11 Md. R. 1273); December 1, 1986 (13:22 Md. R. 2398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); adopted permanently effective October 6, 1986 (13:20 Md. R. 2210)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E repealed and new Regulation .07E adopted effective February 9, 1987 (14:3 Md. R. 273); amended October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L adopted effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M adopted effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, D amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 21, 1995 (22:16 Md. R. 1218); adopted permanently effective November 20, 1995 (22:23 Md. R. 1801)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 18, 2000 (27:18 Md. R. 1665); April 29, 2002 (29:8 Md. R. 700); July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective April 29, 2002 (29:8 Md. R. 700); July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 29, 2002 (29:8 Md. R. 700); January 1, 2018 (44:26 Md. R. 1214); July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 18, 2000 (27:18 Md. R. 1665); October 10, 2016 (43:20 Md. R. 1109); January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective April 29, 2002 (29:8 Md. R. 700)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, D amended effective April 29, 2002 (29:8 Md. R. 700)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, D amended effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, H amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 12, 2011 (38:25 Md. R. 1581); February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, E amended effective June 14, 2021 (48:12 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, M amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L-P adopted effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended effective July 31, 2017 (44:15 Md. R. 759)</annotation> </annotations> </chapter> <chapter num="10" heading="Nursing Facility Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accrual basis” means recording revenue in the period when earned, regardless of when collected, and recording expenses in the period when incurred, regardless of when paid.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative day” means a day of care rendered to a recipient who no longer requires the level of care being provided.</text> </paragraph> <paragraph num="(3)"> <text>“Allowable cost” means costs that are includable in the per diem rate and that represent the provider's actual cost as verified by the Department or the Department's designee.</text> </paragraph> <paragraph num="(4)"> <text>“Appropriate facility” means a facility located within a 25-mile radius of the location of the facility currently rendering care to the recipient or a more distant facility if acceptable to the recipient, which facility is licensed and certified to render the recipient's required level of care.</text> </paragraph> <paragraph num="(5)"> <text>“Bad debts” means amounts considered to be uncollectible from accounts and notes receivable that were created or acquired in providing services. “Accounts receivable” and “notes receivable” are designations for claims arising from rendering services which, when made or entered, were considered collectible in money in the relatively near future.</text> </paragraph> <paragraph num="(6)"> <text>“Case mix index (CMI)” means a numeric score that identifies the average relative nursing resource needs for the residents classified under the Resource Utilization Group (RUG) based on the assessed nursing needs of the resident, whose values are set forth as CMI Set F01, located at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIMDS30TechnicalInformation.html.</text> </paragraph> <paragraph num="(7)"> <text>“Centers for Medicare and Medicaid Services (CMS)” means the federal agency that is located in the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs.</text> </paragraph> <paragraph num="(8)"> <text>“Change of ownership” means:</text> <paragraph num="(a)"> <text>One of the following occurs:</text> <paragraph num="(i)"> <text>The merger of the provider into the acquiring entity and the acquiring entity's tax identification number remains;</text> </paragraph> <paragraph num="(ii)"> <text>The assignment, transfer, disposition, lease, or sale of all or substantially all of a provider’s assets to another entity;</text> </paragraph> <paragraph num="(iii)"> <text>The consolidation of two or more providers, resulting in the creation of a new entity; or</text> </paragraph> <paragraph num="(iv)"> <text>The merger of the provider into another entity, or the consolidation of two or more entities, resulting in the creation of a new entity;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A provider’s Medical Assistance participating provider number dissolves or will no longer be utilized for purposes of billing the Program for covered services; and</text> </paragraph> <paragraph num="(c)"> <text>A new Medical Assistance participating provider number or tax identification number is used instead.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Cost center” means one of the groups into which similar categories of costs are assigned for reimbursement rate determination: Administrative and Routine, Other Patient Care, Nursing Service, and Capital.</text> </paragraph> <paragraph num="(10)"> <text>“Cost report period case mix index” means the simple average of the day weighted facility case mix indices for residents of all payer sources from the final quarterly resident rosters for a nursing facility, carried to four decimal places, for the quarterly resident roster periods that most closely match a cost reporting period.</text> </paragraph> <paragraph num="(11)"> <text>“Credit balance” means:</text> <paragraph num="(a)"> <text>A third party payment, which is in addition to the Medicaid payment;</text> </paragraph> <paragraph num="(b)"> <text>The Medicaid payment in excess of the amount due the provider; or</text> </paragraph> <paragraph num="(c)"> <text>A duplicate payment.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(13)"> <text>“Facility” means a facility licensed under COMAR 10.07.02 and certified as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility.</text> </paragraph> <paragraph num="(14)"> <text>“Facility average Medicaid case mix index” means the day-weighted average case mix index for all identified Medicaid days from each nursing facility's final resident roster for each resident roster quarter calculated as the sum of the number of days each assessment associated with a Medicaid payer source is active times the assessment CMI divided by the sum of all Medicaid payer source days.</text> </paragraph> <paragraph num="(15)"> <text>“Final report” means the third party liability audit report issued to a provider stating the total amount due to the Department as a result of the completed audit.</text> </paragraph> <paragraph num="(16)"> <text>“Fiscal year” means a 12-month reporting period covering the same period as the facility's tax return, unless waived by the Department according to standards found in Medicare Provider Reimbursement Manual, HCFA Publication 15-1.</text> </paragraph> <paragraph num="(17)"> <text>“Indemnity bond” means a bond posted by the provider to ensure that the provider is able to fulfill any financial obligations to the Department upon sale of the facility.</text> </paragraph> <paragraph num="(18)"> <text>“Interim Working Capital Fund” means funding made available to providers on a temporary basis that shall be repaid to the Department.</text> </paragraph> <paragraph num="(19)"> <text>“Market basket index” means inflation indices from the latest Skilled Nursing Home without Capital Market Basket Index, published 2 months before the period in which rates are being calculated and which is available from CMS at www.cms.gov, or a comparable index available from, and used by, CMS, if this index ceases to be published by Global Insight, Inc. or its successor.</text> </paragraph> <paragraph num="(20)"> <text>“Maryland Health Care Commission” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act.</text> </paragraph> <paragraph num="(22)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(23)"> <text>“Medicare upper payment limit” means that aggregate payments to nursing facilities may not exceed the limits established for such payment in 42 CFR §447.272.</text> </paragraph> <paragraph num="(24)"> <text>“Minimum Data Set (MDS)” means the MDS required by 42 CFR §483.20 and set forth in the Resident Assessment Instrument published by CMS, and available at www.cms.gov, incorporated herein by reference, as amended and supplemented, a core set of screening, clinical, and functional status elements, including common definitions and coding categories that forms the foundation of the assessment required for all residents in Medicare-certified or Medicaid-certified nursing facilities.</text> </paragraph> <paragraph num="(25)"> <text>“New facility” means:</text> <paragraph num="(a)"> <text>A facility that has not been a provider during the previous 12-month period or, for rates effective January 1, 2015 and after, does not have a cost report in the price database as set forth in Regulation .09B(1) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>A facility not defined as a replacement facility.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Noncompliant” means:</text> <paragraph num="(a)"> <text>A provider fails to submit to the Department the required quarterly report of credit balances;</text> </paragraph> <paragraph num="(b)"> <text>A provider fails to submit a quarterly report which provides sufficient data relating to the credit balances it maintained during that quarter; or</text> </paragraph> <paragraph num="(c)"> <text>A random audit by the Department reveals errors or omissions in a provider's credit balance report.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>Nursing Facility (NF).</text> <paragraph num="(a)"> <text>“Nursing facility” means an institution which is primarily engaged in providing to residents:</text> <paragraph num="(i)"> <text>Skilled nursing care and related services for residents who require medical or nursing care;</text> </paragraph> <paragraph num="(ii)"> <text>Rehabilitation services for the rehabilitation of injured, disabled, or sick persons; or</text> </paragraph> <paragraph num="(iii)"> <text>On a regular basis, health-related care and services to individuals who, because of their mental or physical condition, require care and services (above the level of room and board) which can be made available to them only through institutional facilities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02.</text> </paragraph> <paragraph num="(c)"> <text>“Nursing facility” does not include an institution which is primarily for the care and treatment of mental diseases, an intellectually disability or a developmental disability.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of their mental or physical condition, require skilled nursing care and related services, rehabilitation services, or, on a regular basis, health-related care and services (above the level of room and board) which can be made available to them only through institutional facilities.</text> </paragraph> <paragraph num="(29)"> <text>“Owner” means a party or entity having any ownership interest in the facility.</text> </paragraph> <paragraph num="(30)"> <text>“Patient day” means care of one patient for 1 day of service. The day of admission is counted as 1 day of care, but the day of discharge is not counted. If a patient is discharged on his day of admission, 1 patient day will be counted.</text> </paragraph> <paragraph num="(31)"> <text>“Payroll-Based Journal” means a system for facilities to submit staffing information to meet the requirements of §6106 of the Affordable Care Act (ACA) that requires facilities to electronically submit direct care staffing information (including agency and contract staff) based on payroll and other auditable data.</text> </paragraph> <paragraph num="(32)"> <text>“Personal needs fund” means that portion of the recipient's resource retained by the recipient for his personal use.</text> </paragraph> <paragraph num="(33)"> <text>“Predischarge plan” means:</text> <paragraph num="(a)"> <text>A written document describing who has operational responsibility for discharge planning;</text> </paragraph> <paragraph num="(b)"> <text>The manner in and methods by which that person will function;</text> </paragraph> <paragraph num="(c)"> <text>The time period in which each recipient's need for discharge planning will be determined;</text> </paragraph> <paragraph num="(d)"> <text>The maximum time period after which a reevaluation of each recipient's discharge plan will be made;</text> </paragraph> <paragraph num="(e)"> <text>The local resources available to the provider, the individual, and the attending physician to assist in developing and implementing individual discharge plans; and</text> </paragraph> <paragraph num="(f)"> <text>Provisions for periodic review and reevaluation of the provider's discharge planning program.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Program” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(35)"> <text>“Prospective rate” means a facility-specific quarterly per diem rate based on the RUG classification system, and calculated as the sum of:</text> <paragraph num="(a)"> <text>Administrative and Routine rate as calculated in accordance with Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Other Patient Care Rate as calculated in accordance with Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Capital Rate as calculated in accordance with Regulation .11 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Nursing Rate as calculated in accordance with Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Provider” means a facility which has in effect a provider agreement with the Department.</text> </paragraph> <paragraph num="(37)"> <text>“Provider agreement” means the contract between the Department and the provider covering the obligations of the parties under the Medical Assistance Program.</text> </paragraph> <paragraph num="(38)"> <text>“Purchaser” means an entity that participates in a change of ownership with a provider by:</text> <paragraph num="(a)"> <text>Having a provider merge into the entity;</text> </paragraph> <paragraph num="(b)"> <text>Accepting the assignment, transfer, disposition, or sale of all or substantially all of a provider’s assets; or</text> </paragraph> <paragraph num="(c)"> <text>Being a new entity that results from the consolidation of the provider with a third party.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Quality measure” means a specific performance criterion, as described in Regulation .15 of this chapter, used to assess a facility’s performance level.</text> </paragraph> <paragraph num="(40)"> <text>“Random sample” means the selection for audit by the Department of representative share of the providers complying with the requirement of submitting a quarterly report of credit balances to the Department.</text> </paragraph> <paragraph num="(41)"> <text>“Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(42)"> <text>“Recreational services” means those organized activities provided for the enjoyment of the patients that are designed to promote their physical, social, and mental well-being.</text> </paragraph> <paragraph num="(43)"> <text>“Reimbursement class” means the group of providers for which a separate per diem rate will be prepared in the Administrative and Routine, Other Patient Care, and Nursing Service cost centers based on geographic region as set forth in Regulation .30 of this chapter.</text> </paragraph> <paragraph num="(44)"> <text>“Relative of the owner” means the owner's husband, wife, natural parent, natural child, sibling, adopted child, adoptive parent, stepparent, stepchild, stepbrother, stepsister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild.</text> </paragraph> <paragraph num="(45)"> <text>“Replacement facility” means:</text> <paragraph num="(a)"> <text>A newly constructed nursing facility that replaces an existing licensed and certified facility; or</text> </paragraph> <paragraph num="(b)"> <text>A facility that was closed for significant renovation that reopens and is approved by the Department as a replacement facility.</text> </paragraph> </paragraph> <paragraph num="(46)"> <text>“Resident roster” means a list of all residents in a nursing facility for a calendar quarter based on MDS assessments and tracking forms, accurately and successfully transmitted by the nursing facility into the CMS-approved submission system, used for the calculated day-weighted case mix indices for Medicaid, Medicare, and other payment sources.</text> </paragraph> <paragraph num="(47)"> <text>“Resource” means that portion of a recipient's income available toward the cost of medical and remedial care as determined by the Department or its designee.</text> </paragraph> <paragraph num="(48)"> <text>“Resource Utilization Group (RUG)” means the version IV (RUG-IV), 48-Group classification system, that has been developed by CMS for grouping nursing facility residents according to the residents’ functional status and anticipated uses of services and resources as identified from data supplied by the MDS.</text> </paragraph> <paragraph num="(49)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(50)"> <text>“Special focus facility” means a facility identified by the Centers for Medicare and Medicaid Services as having:</text> <paragraph num="(a)"> <text>More problems than other nursing homes;</text> </paragraph> <paragraph num="(b)"> <text>More serious problems than other nursing homes; and</text> </paragraph> <paragraph num="(c)"> <text>A pattern of serious problems that has persisted over a long period of time.</text> </paragraph> </paragraph> <paragraph num="(51)"> <text>“Specialized rehabilitative therapy services” means those services furnished by a provider as an integral part of a patient's care plan ordered by a physician and provided in conjunction with continuous nursing care for the purpose of the restoration of normal form and function after injury or illness. The services shall be performed by a licensed physical therapist, licensed physical therapy assistant, or registered occupational therapist.</text> </paragraph> <paragraph num="(52)"> <text>“Standby letter of credit” means a written instrument prepared by a provider's bank authorizing the Department to draw on the bank, upon sale of the facility.</text> </paragraph> <paragraph num="(53)"> <text>“Statewide average case mix index” means the simple average of all of the cost report period case mix indices for the rate year.</text> </paragraph> <paragraph num="(54)"> <text>“Statewide average Medicaid case mix index” means the Medicaid day weighted average of all nursing facilities’ case mix indices for the Medicaid days identified on the final resident rosters for each resident roster quarter.</text> </paragraph> <paragraph num="(55)"> <text>“Substandard quality of care” means a finding of substandard care in accordance with 42 CFR §488.301.</text> </paragraph> <paragraph num="(56)"> <text>“Third party” means any individual entity or program that is or may be liable to pay all or part of the medical cost of any medical assistance furnished to a recipient under the Medical Assistance Program, including private health insurance, employment related health insurance, medical support from absent parents, automobile insurance, court judgments or settlements from a liability insurer, state workers' compensation, first party probate-estate recoveries, or any federal programs.</text> </paragraph> <paragraph num="(57)"> <text>“Third party liability audit” means a financial review of Medical Assistance payments to a provider to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program.</text> </paragraph> <paragraph num="(58)"> <text>“Third party liability review” means a financial review of the credit balances of a nursing facility to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program.</text> </paragraph> <paragraph num="(59)"> <text>“Uniform cost report” means the cost report format which each facility is required to use in the submission of its fiscal year cost and utilization data, including supplemental schedules and other balance sheet and administrative data.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>In order to participate in the Program, a provider shall be licensed by the Department, pursuant to Health-General Article, §19-301 et seq., Annotated Code of Maryland, and COMAR 10.07.02, and shall obtain other licenses, as may be required by applicable State and local laws.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Be certified by the Department at its total licensed nursing facility bed capacity as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility;</text> </paragraph> <paragraph num="B."> <text>Be in compliance with preadmission screening and resident review requirements as described by 42 CFR Part 483, Subpart C (1996);</text> </paragraph> <paragraph num="C."> <text>Be in compliance with the requirements of COMAR 10.09.36;</text> </paragraph> <paragraph num="D."> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="E."> <text>Have a provider agreement in effect;</text> </paragraph> <paragraph num="F."> <text>Employ an organized medical staff or a medical director who is a licensed physician;</text> </paragraph> <paragraph num="G."> <text>Provide, according to the needs of the recipient, those services listed in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="H."> <text>Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services except as provided for in Regulation .28 of this chapter;</text> </paragraph> <paragraph num="I."> <text>Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="J."> <text>Provide services without regard to race, color, age, sex, national origin, marital status, physical or mental handicap;</text> </paragraph> <paragraph num="K."> <text>Verify the recipient's eligibility;</text> </paragraph> <paragraph num="L."> <text>Place no restriction on a recipient's right to select providers of his choice;</text> </paragraph> <paragraph num="M."> <text>Have in effect a predischarge plan;</text> </paragraph> <paragraph num="N."> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized in accordance with Regulation .06 of this chapter, the provider may not seek payment for that service from the recipient;</text> </paragraph> <paragraph num="O."> <text>Perform utilization control functions for all recipients designated eligible for nursing facility services as described by 42 CFR §§346.370, 456.360, 456.371, 456.380, and 456.381 (1996), and as required by the Utilization Control Plan for Selected Institutional Services Reimbursed by the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="P."> <text>Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement on such form and at such time as specified by the Department;</text> </paragraph> <paragraph num="Q."> <text>Before discharging any Medical Assistance recipient certified as requiring nursing facility services, place in the recipient's permanent medical record the following information on a consent form designated by the Department, a copy of which shall be submitted to the Department and to the Office on Aging:</text> <paragraph num="(1)"> <text>A certification that the recipient or guardian has:</text> <paragraph num="(a)"> <text>Been informed of the recipient's right to remain in the discharging facility and have the cost of care paid by the Medical Assistance Program;</text> </paragraph> <paragraph num="(b)"> <text>Been informed that the Medical Assistance Program will not pay for room and board in a setting outside of a nursing facility and that the Program may pay for the cost of medical services received outside of a nursing facility subject to medical and financial eligibility determinations and covered services limitations;</text> </paragraph> <paragraph num="(c)"> <text>Been informed of the recipient's right as a patient, as stated in the Health-General Article, §19-345, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>Been informed of the services provided by and the location of the alternative placement;</text> </paragraph> <paragraph num="(e)"> <text>Voluntarily given informed consent to the transfer;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the recipient or guardian is unable or unwilling to sign the consent form, submit to the Department a written explanation of the reason written consent was not obtained, a copy of which shall be placed in the recipient's medical record;</text> </paragraph> </paragraph> <paragraph num="R."> <text>Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient;</text> </paragraph> <paragraph num="S."> <text>Include in all contracts with a cost or value over a 12-month period of $10,000 or more, with any subcontractor, a clause allowing the Department or its agent access to the subcontractor's books, documents, and records which are necessary to verify the nature and extent of costs of the services furnished under the contract in accordance with the principles established under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., and contained in the Medicare Provider Reimbursement Manual, HCFA Publication 15-1;</text> </paragraph> <paragraph num="T."> <text>Meet the requirements in the Certificate of Need application approved by the Maryland Health Resources Planning Commission;</text> </paragraph> <paragraph num="U."> <text>Notify the Medical Assistance Program, in writing, of the contemplated sale of the facility or a controlling interest not less than 30 days before the date of the change of ownership;</text> </paragraph> <paragraph num="V."> <text>Assure that an individual who is eligible for Medical Assistance at the time of application for admission to a nursing home, or would become eligible within 6 months following admission, has a long-term care assessment made available before admission, at no charge to the individual, pursuant to COMAR 10.09.30. The evaluation is advisory only and may not restrict the right of an individual to select nursing home services; and</text> </paragraph> <paragraph num="W."> <text>Not less than 30 days before the date of any change of ownership, except when the Program agrees to a shorter period, provide the Department the notification and indemnity bond, letter of credit, or certificate of assurance required by Regulation .25D(1)—(3) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers routine care and the following supplies, equipment, and services when appropriate to meet the needs of the recipient:</text> <paragraph num="A."> <text>Those described in the Maryland Department of Health regulations entitled “Requirements for Long Term Care Facilities”, 42 CFR Part 483, Subpart B (1996), subject to limitations in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Over-the-counter drugs.</text> </paragraph> <paragraph num="C."> <text>Bed reservations for recipients who are on a leave of absence to visit with friends or relatives or to participate in State-approved therapeutic or rehabilitative programs for a maximum of 18 days in any calendar year and without any limitation on the number of days per visit.</text> </paragraph> <paragraph num="D."> <text>Repealed.</text> </paragraph> <paragraph num="E."> <text>Administrative days approved by the Department or its designee according to the conditions set forth in Regulation .26D of this chapter.</text> </paragraph> <paragraph num="F."> <text>Specialized rehabilitative therapy services which meet the conditions listed below:</text> <paragraph num="(1)"> <text>Physical Therapy. Physical therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions:</text> <paragraph num="(a)"> <text>The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified physical therapist;</text> </paragraph> <paragraph num="(b)"> <text>The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, or skills of a qualified physical therapist;</text> </paragraph> <paragraph num="(c)"> <text>The services are performed by or under the supervision of a qualified physical therapist;</text> </paragraph> <paragraph num="(d)"> <text>The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified physical therapist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time;</text> </paragraph> <paragraph num="(e)"> <text>The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and</text> </paragraph> <paragraph num="(f)"> <text>The services are reasonable and necessary to the treatment of the recipient's condition.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Occupational Therapy. Occupational therapy services for Medical Assistance Program purposes are those which meet the following conditions:</text> <paragraph num="(a)"> <text>The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>The services are on a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified occupational therapist;</text> </paragraph> <paragraph num="(c)"> <text>The services are performed by a qualified occupational therapist;</text> </paragraph> <paragraph num="(d)"> <text>The services are for the purposes of improving or restoring functions which have been impaired by illness or injury or, if function has been permanently lost or reduced by illness or injury, to improve the individual's ability to perform those tasks required for independent functioning;</text> </paragraph> <paragraph num="(e)"> <text>The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and</text> </paragraph> <paragraph num="(f)"> <text>The services are reasonable and necessary to the treatment of the recipient's condition.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Speech Therapy. Speech therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions:</text> <paragraph num="(a)"> <text>The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified speech and language pathologist;</text> </paragraph> <paragraph num="(b)"> <text>The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified speech and language pathologist;</text> </paragraph> <paragraph num="(c)"> <text>The services are performed by or under the supervision of a qualified speech and language pathologist;</text> </paragraph> <paragraph num="(d)"> <text>The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified speech and language pathologist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time;</text> </paragraph> <paragraph num="(e)"> <text>The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and</text> </paragraph> <paragraph num="(f)"> <text>The services are reasonable and necessary to the treatment of the recipient's condition.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Supplies and equipment necessary to meet the needs of the recipient, including but not limited to:</text> <paragraph num="(1)"> <text>ABD pads.</text> </paragraph> <paragraph num="(2)"> <text>Adhesive strip bandages.</text> </paragraph> <paragraph num="(3)"> <text>Adhesive tape (regular and non-allergenic).</text> </paragraph> <paragraph num="(4)"> <text>Airways — oral and nasal.</text> </paragraph> <paragraph num="(5)"> <text>Alcohol and alcohol sponges.</text> </paragraph> <paragraph num="(6)"> <text>Ambu bags.</text> </paragraph> <paragraph num="(7)"> <text>Antiseptics and cleansing agents (over-the-counter).</text> </paragraph> <paragraph num="(8)"> <text>Applicators.</text> </paragraph> <paragraph num="(9)"> <text>Bandages.</text> </paragraph> <paragraph num="(10)"> <text>Beds, high-low, adjustable.</text> </paragraph> <paragraph num="(11)"> <text>Bed pans and urinals.</text> </paragraph> <paragraph num="(12)"> <text>Bed rails.</text> </paragraph> <paragraph num="(13)"> <text>Bibs.</text> </paragraph> <paragraph num="(14)"> <text>Body lotions (over-the-counter).</text> </paragraph> <paragraph num="(15)"> <text>Canes.</text> </paragraph> <paragraph num="(16)"> <text>Catheters (including Foley or other indwelling).</text> </paragraph> <paragraph num="(17)"> <text>Catheter trays.</text> </paragraph> <paragraph num="(18)"> <text>Chest or body restraints.</text> </paragraph> <paragraph num="(19)"> <text>Clean catch kits.</text> </paragraph> <paragraph num="(20)"> <text>Clinical medicine glasses — disposable or otherwise.</text> </paragraph> <paragraph num="(21)"> <text>Cotton and cotton balls.</text> </paragraph> <paragraph num="(22)"> <text>Covered water pitchers.</text> </paragraph> <paragraph num="(23)"> <text>Crutches.</text> </paragraph> <paragraph num="(24)"> <text>Dentifrices and denture adhesives.</text> </paragraph> <paragraph num="(25)"> <text>Denture cups.</text> </paragraph> <paragraph num="(26)"> <text>Deodorant (personal and room).</text> </paragraph> <paragraph num="(27)"> <text>Diagnostic aids (Clinitest, Acetest, Hematest, Testape, etc.).</text> </paragraph> <paragraph num="(28)"> <text>Dietary supplements (including tube feeding).</text> </paragraph> <paragraph num="(29)"> <text>Disposable diapers or incontinency care pads.</text> </paragraph> <paragraph num="(30)"> <text>Disposable wash cloths.</text> </paragraph> <paragraph num="(31)"> <text>Douche apparatus.</text> </paragraph> <paragraph num="(32)"> <text>Drainage bags and catheter tubing.</text> </paragraph> <paragraph num="(33)"> <text>Emesis basins.</text> </paragraph> <paragraph num="(34)"> <text>Enema apparatus.</text> </paragraph> <paragraph num="(35)"> <text>Enemas and douches (including prepared).</text> </paragraph> <paragraph num="(36)"> <text>Eye pads.</text> </paragraph> <paragraph num="(37)"> <text>First aid supplies.</text> </paragraph> <paragraph num="(38)"> <text>Gauzes.</text> </paragraph> <paragraph num="(39)"> <text>Hot water bottles and covers.</text> </paragraph> <paragraph num="(40)"> <text>Hydraulic lifts.</text> </paragraph> <paragraph num="(41)"> <text>Ice bags.</text> </paragraph> <paragraph num="(42)"> <text>Infusionarm boards.</text> </paragraph> <paragraph num="(43)"> <text>Intermittent positive pressure breathing machines (I.P.P.B.).</text> </paragraph> <paragraph num="(44)"> <text>Intravenous poles, portable.</text> </paragraph> <paragraph num="(45)"> <text>Irrigation trays.</text> </paragraph> <paragraph num="(46)"> <text>Levine tubes (plastic or regular).</text> </paragraph> <paragraph num="(47)"> <text>Lubricants and oils.</text> </paragraph> <paragraph num="(48)"> <text>Mouth washes.</text> </paragraph> <paragraph num="(49)"> <text>Nasal atomizers.</text> </paragraph> <paragraph num="(50)"> <text>Needles (cardiac, clysis or intravenous, permanent or disposable).</text> </paragraph> <paragraph num="(51)"> <text>Oxygen for occasional and emergency use. Continuous oxygen is covered under the provisions of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services.</text> </paragraph> <paragraph num="(52)"> <text>Oxygen masks, cannulas, catheters, and related equipment, including portable equipment for use with occasional or emergency oxygen. Equipment used for continuous use oxygen is covered under the provision of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services.</text> </paragraph> <paragraph num="(53)"> <text>Paper tissues.</text> </paragraph> <paragraph num="(54)"> <text>Personal toilet items (toothbrush, soap, shampoo, razor, shaving cream, sanitary pads).</text> </paragraph> <paragraph num="(55)"> <text>Petroleum jelly.</text> </paragraph> <paragraph num="(56)"> <text>Powder, medicated or non-medicated—over-the-counter.</text> </paragraph> <paragraph num="(57)"> <text>Pumps, aspiration and suction.</text> </paragraph> <paragraph num="(58)"> <text>Rectal tubes.</text> </paragraph> <paragraph num="(59)"> <text>Rubber or plastic gloves and finger cots.</text> </paragraph> <paragraph num="(60)"> <text>Rubber or plastic pants.</text> </paragraph> <paragraph num="(61)"> <text>Rubber or plastic sheeting.</text> </paragraph> <paragraph num="(62)"> <text>Rubber or sponge rings.</text> </paragraph> <paragraph num="(63)"> <text>Sand bags.</text> </paragraph> <paragraph num="(64)"> <text>Scales, including chair scales.</text> </paragraph> <paragraph num="(65)"> <text>Sheepskin, natural or synthetic.</text> </paragraph> <paragraph num="(66)"> <text>Slings.</text> </paragraph> <paragraph num="(67)"> <text>Special mattresses for decubiti care.</text> </paragraph> <paragraph num="(68)"> <text>Sphygmomanometers.</text> </paragraph> <paragraph num="(69)"> <text>Stethoscopes.</text> </paragraph> <paragraph num="(70)"> <text>Stryker and Foster frames.</text> </paragraph> <paragraph num="(71)"> <text>Suction machines, gastric and tracheal.</text> </paragraph> <paragraph num="(72)"> <text>Suction tubing.</text> </paragraph> <paragraph num="(73)"> <text>Surgical dressings, including sterile sponges.</text> </paragraph> <paragraph num="(74)"> <text>Suture removal kits.</text> </paragraph> <paragraph num="(75)"> <text>Suture trays.</text> </paragraph> <paragraph num="(76)"> <text>Syringes, plastic, glass, or bulb.</text> </paragraph> <paragraph num="(77)"> <text>Tape removers.</text> </paragraph> <paragraph num="(78)"> <text>Thermometers, oral, rectal, universal, bath.</text> </paragraph> <paragraph num="(79)"> <text>Tongue depressors.</text> </paragraph> <paragraph num="(80)"> <text>Tracheostomy equipment and supplies.</text> </paragraph> <paragraph num="(81)"> <text>Traction equipment.</text> </paragraph> <paragraph num="(82)"> <text>Trapeze and bed frame equipment.</text> </paragraph> <paragraph num="(83)"> <text>Trays, cut-down.</text> </paragraph> <paragraph num="(84)"> <text>Tubing.</text> </paragraph> <paragraph num="(85)"> <text>Walkers and walkerettes.</text> </paragraph> <paragraph num="(86)"> <text>Wheel chairs.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Administration of enemas.</text> </paragraph> <paragraph num="I."> <text>Administration of oxygen.</text> </paragraph> <paragraph num="J."> <text>Back rubs.</text> </paragraph> <paragraph num="K."> <text>Decubiti care and over-the-counter medication.</text> </paragraph> <paragraph num="L."> <text>Colostomy, ileostomy, and nephrostomy care.</text> </paragraph> <paragraph num="M."> <text>Hand feeding or self-help eating devices.</text> </paragraph> <paragraph num="N."> <text>Incontinency care.</text> </paragraph> <paragraph num="O."> <text>Personal laundry.</text> </paragraph> <paragraph num="P."> <text>Personal toilet (routine shaving, hair washing and arranging, routine toenail clipping, adequate bathing).</text> </paragraph> <paragraph num="Q."> <text>Private room for isolation purposes.</text> </paragraph> <paragraph num="R."> <text>Special diets, including diabetic.</text> </paragraph> <paragraph num="S."> <text>Tray service.</text> </paragraph> <paragraph num="T."> <text>Tube feeding.</text> </paragraph> <paragraph num="U."> <text>Portable X-ray services.</text> </paragraph> <paragraph num="V."> <text>Respirator management in licensed comprehensive care beds which have been determined by the Department to meet the standards for respiratory care units under COMAR 10.07.02.</text> </paragraph> <paragraph num="W."> <text>Intravenous therapy and venipuncture.</text> </paragraph> <paragraph num="X."> <text>Noninvasive traction apparatus services (cervical, Buck's extension, pelvic).</text> </paragraph> <paragraph num="Y."> <text>Emergency resuscitation procedures, including coronary pulmonary procedures.</text> </paragraph> <paragraph num="Z."> <text>Restorative nursing care.</text> </paragraph> <paragraph num="AA."> <text>Physician-ordered physical restraints and protective devices.</text> </paragraph> <paragraph num="BB."> <text>Negative pressure wound therapy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The following are not covered:</text> <paragraph num="A."> <text>Services by an out-of-State nursing facility unless the Department and the nursing facility execute a provider agreement;</text> </paragraph> <paragraph num="B."> <text>Audiology services;</text> </paragraph> <paragraph num="C."> <text>Services reimbursed under Title XVIII of the Social Security Act; and</text> </paragraph> <paragraph num="D."> <text>Services for which payment is made directly to a provider other than the nursing facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The Department of Human Services shall certify the recipient for financial eligibility, and the Department or its designee shall certify the recipient as requiring nursing facility services, except as provided in Regulation .26D of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee will certify as requiring nursing facility services only those financially eligible recipients requiring nursing facility services as defined in Regulation .01B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prospective Rates."> <paragraph num="A."> <text>A provider shall be paid the prospective rate for nursing facility services as defined in Regulation .01B of this chapter plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter.</text> </paragraph> <paragraph num="B."> <text>When necessary, each facility’s per diem rate shall be reduced by the same percentage to maintain compliance with the Medicare upper payment limit requirement.</text> </paragraph> <paragraph num="C."> <text>Power wheelchairs and bariatric beds are not included in the prospective rate, but may be preauthorized for payment in accordance with COMAR 10.09.12.</text> </paragraph> <paragraph num="D."> <text>Support Surfaces.</text> <paragraph num="(1)"> <text>Support surfaces are not included in the prospective rate.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid a per diem rate for providing appropriate specialized support surfaces to patients with pressure ulcers or in recovery from myocutaneous flap or graft surgery for a pressure ulcer.</text> </paragraph> <paragraph num="(3)"> <text>A Class A support surface is a mattress replacement which has been approved as a Group 2 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class A support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0277 multiplied by 12 and then divided by the number of days in the State fiscal year.</text> </paragraph> <paragraph num="(4)"> <text>A Class B support surface is an air fluidized bed which has been approved as a Group 3 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class B support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0194 multiplied by 12 and then divided by the number of days in the State fiscal year.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Negative pressure wound therapy is not included in the prospective rate, but is reimbursed in accordance with rates established under COMAR 10.09.12. Reimbursement shall include the cost of pumps, dressings, and containers associated with this procedure.</text> </paragraph> <paragraph num="F."> <text>Nursing facilities that are owned and operated by the State are not paid in accordance with the provisions of §A of this regulation, but are reimbursed reasonable costs based upon Medicare principles of reasonable costs as described at 42 CFR Part 413. Aggregate payments for these facilities may not exceed Medicare upper payment limits as specified at 42 CFR §447.272. If the Medicare upper payment limit is above aggregate costs for this ownership class, the State may elect to make supplemental payments to increase payments up to the Medicare upper payment limit.</text> </paragraph> <paragraph num="G."> <text>Final facility rates for the period July 1, 2024 through June 30, 2025 shall be each nursing facility’s quarterly rate, exclusive of the amount identified in Regulation .13A(2) of this chapter, increased by the budget adjustment factor of 2.703 percent, plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter and the ventilator care add-on amount identified in Regulation .13A(2) of this chapter when applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Interim Working Capital Fund."> <paragraph num="A."> <text>A provider may request an allotment from the Interim Working Capital Fund if the facility for which an allotment is requested has not had any of the following deficiencies cited in any survey conducted by the Office of Health Care Quality during the calendar year preceding the calculation of the allotment, using the scope and severity matrix found in the Centers for Medicare and Medicaid Services State Operations Manual for Survey and Certification, Part 7, §7400E:</text> <paragraph num="(1)"> <text>Two or more “G” level deficiencies; or</text> </paragraph> <paragraph num="(2)"> <text>One or more “H” or higher level deficiencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A provider operating a facility with any of the deficiencies described in §A of this regulation may be eligible for an allotment if the facility has undergone an arm's length change of ownership, as determined by the Department, since the latest survey that resulted in the deficiencies.</text> </paragraph> <paragraph num="C."> <text>The Department may deny an allotment from the Interim Working Capital Fund if the Department, based on sufficient information, concludes that the requesting provider is not able to repay the allotment on a timely basis.</text> </paragraph> <paragraph num="D."> <text>The maximum allotment for any provider shall be 0.015 times the total Medicaid payments to that provider in the prior State fiscal year.</text> </paragraph> <paragraph num="E."> <text>Recalculation.</text> <paragraph num="(1)"> <text>In March of each year, the Department shall recalculate the maximum allotment based on Medicaid payments for the prior State fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>If the recalculated maximum allotment is:</text> <paragraph num="(a)"> <text>Less than the amount the provider carried over from the prior year, the provider shall repay the difference to the Department within 30 days of the date the Department provides notice that a repayment is due; or</text> </paragraph> <paragraph num="(b)"> <text>Greater than the amount carried over from the prior year, the provider may request the difference from the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Revocation.</text> <paragraph num="(1)"> <text>The Department may revoke the allotment based on:</text> <paragraph num="(a)"> <text>Quality of care violations;</text> </paragraph> <paragraph num="(b)"> <text>Changes in business practice that are detrimental to Medicaid recipients;</text> </paragraph> <paragraph num="(c)"> <text>Impending bankruptcy; or</text> </paragraph> <paragraph num="(d)"> <text>Other good cause shown.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department revokes the allotment, the provider shall repay the total allotment to the Department within 15 days of the notice of revocation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>In order to obtain an allotment, the provider shall agree that it holds the allotment in constructive trust for the State subject to recoupment or immediate payment on demand by the State.</text> </paragraph> <paragraph num="H."> <text>The Interim Working Capital Fund expires on May 1, 2025. Providers shall repay all outstanding funds to the Department by May 1, 2025. The Department may grant repayment extensions, not longer than 60 days, under extraordinary circumstances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Rate Calculation — Administrative and Routine Costs."> <paragraph num="A."> <text>The Administrative and Routine cost center includes:</text> <paragraph num="(1)"> <text>Administrative expenses;</text> </paragraph> <paragraph num="(2)"> <text>Medical records expenses;</text> </paragraph> <paragraph num="(3)"> <text>Training expenses;</text> </paragraph> <paragraph num="(4)"> <text>Dietary;</text> </paragraph> <paragraph num="(5)"> <text>Laundry;</text> </paragraph> <paragraph num="(6)"> <text>Housekeeping;</text> </paragraph> <paragraph num="(7)"> <text>Operation and maintenance; and</text> </paragraph> <paragraph num="(8)"> <text>Capitalized organization and start-up costs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall initially establish cost center prices for the rate period January 1, 2015 through June 30, 2015, and thereafter rebase the cost center prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or, if a significant change in provider behavior or costs has resulted in payment that is inequitable, across providers. The Department shall rebase based on the following steps:</text> <paragraph num="(1)"> <text>The price database shall be established using the most recent desk reviewed Nursing Home Uniform Cost Report for each current provider, or the immediately prior owner of that nursing facility, that is available 2 months before the period for which prices are being established or rebased;</text> </paragraph> <paragraph num="(2)"> <text>If no desk reviewed cost report is available, that provider shall be excluded from the price database;</text> </paragraph> <paragraph num="(3)"> <text>The total cost center expenses for each cost report in the price database shall be adjusted from the midpoint of each cost reporting period to the midpoint of the rate year for which the price is being established based on the following steps:</text> <paragraph num="(a)"> <text>A monthly market basket index shall be calculated based on the following calculations:</text> </paragraph> <paragraph num="(b)"> <text>The index factor for each cost reporting period shall be calculated by dividing the index associated with the midpoint of the rate year by the index associated with the midpoint of the cost reporting period; and</text> </paragraph> <paragraph num="(c)"> <text>The indexed costs shall be calculated as total cost center expenses times the index factor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Each cost report's indexed Administrative and Routine costs shall be divided by the greater of total resident days or days at full occupancy times an occupancy standard calculated as the Statewide average occupancy, not including providers with occupancy waivers, plus 1.5 percent to arrive at the Administrative and Routine cost per diem; and</text> </paragraph> <paragraph num="(5)"> <text>For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Administrative and Routine cost per diems identified in §B(4) of this regulation to calculate the Administrative and Routine Medicaid day weighted median as follows:</text> <paragraph num="(a)"> <text>Array the Administrative and Routine cost per diems for each geographic region from low to high;</text> </paragraph> <paragraph num="(b)"> <text>For each Administrative and Routine cost per diem, identify the Medicaid days from the nursing facilities’ cost reports;</text> </paragraph> <paragraph num="(c)"> <text>Calculate a cumulative Medicaid day total; and</text> </paragraph> <paragraph num="(d)"> <text>Identify the median Administrative and Routine cost per diem as the Administrative and Routine per diem associated with the cumulative Medicaid days that first equals or exceeds half the number of total Medicaid days for the geographic region.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The final price for Administrative and Routine costs for each reimbursement class shall be calculated as the geographic regional Medicaid day weighted median multiplied by 1.025.</text> </paragraph> <paragraph num="D."> <text>For years between periods when the prices are rebased, the final cost center price shall be adjusted by the change in the indexes as calculated in §B(3) of this regulation that correspond to midpoint of the prior rate year to the midpoint of the new rate year.</text> </paragraph> <paragraph num="E."> <text>The final Administrative and Routine rate for each nursing facility is the Administrative and Routine price for its reimbursement class.</text> </paragraph> <paragraph num="F."> <text>The reimbursement classes for the Administrative and Routine cost center are specified under Regulation .30A of this chapter.</text> </paragraph> <paragraph num="G."> <text>Kosher Kitchen Add-on.</text> <paragraph num="(1)"> <text>Nursing facilities that maintain kosher kitchens and have Administrative and Routine costs in excess of the Administrative and Routine price in their reimbursement class that are attributable to dietary expense shall receive an add-on to its final price in an amount up to 15 percent of the median per diem cost for dietary expense in its reimbursement class.</text> </paragraph> <paragraph num="(2)"> <text>For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in §B(3)(a) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Rate Calculation — Other Patient Care Costs."> <paragraph num="A."> <text>The Other Patient Care cost center includes:</text> <paragraph num="(1)"> <text>Medical director administrative expenses;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>Recreational activities;</text> </paragraph> <paragraph num="(4)"> <text>Patient care consultant services;</text> </paragraph> <paragraph num="(5)"> <text>Food cost (unprepared);</text> </paragraph> <paragraph num="(6)"> <text>Social services; and</text> </paragraph> <paragraph num="(7)"> <text>Religious services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall initially establish Other Patient Care prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Other Patient Care prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps:</text> <paragraph num="(1)"> <text>The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Each cost report's indexed Other Patient Care costs shall be divided by the actual days of nursing facility services to arrive at the Other Patient Care cost per diem;</text> </paragraph> <paragraph num="(3)"> <text>For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Other Patient Care cost per diems identified in §B(2) of this regulation to calculate the Other Patient Care Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>The final price for Other Patient Care costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median multiplied by 1.07; and</text> </paragraph> <paragraph num="(5)"> <text>For years between periods when the prices are rebased, the final price for Other Patient Care costs shall be calculated as set forth in Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The final Other Patient Care rate for each nursing facility is the Other Patient Care price for its reimbursement class.</text> </paragraph> <paragraph num="D."> <text>The reimbursement classes for the Other Patient Care cost center are specified under Regulation .30B of this chapter.</text> </paragraph> <paragraph num="E."> <text>Kosher Kitchen Add-on.</text> <paragraph num="(1)"> <text>Nursing facilities that maintain kosher kitchens and have Other Patient Care costs in excess of the Other Patient Care price in its reimbursement class that are attributable to food costs shall receive an add-on to its final price an amount up to 15 percent of the median per diem cost for food costs in its reimbursement class.</text> </paragraph> <paragraph num="(2)"> <text>For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in Regulation .09B(3)(a) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Rate Calculation — Capital Costs."> <paragraph num="A."> <text>The Capital cost center includes:</text> <paragraph num="(1)"> <text>Real estate taxes; and</text> </paragraph> <paragraph num="(2)"> <text>Fair rental value.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Final Capital Cost.</text> <paragraph num="(1)"> <text>The determination of a provider's allowable final Capital per diem rate for the cost items under §A of this regulation is calculated as follows:</text> <paragraph num="(a)"> <text>Appraise each facility at least every 4 years;</text> </paragraph> <paragraph num="(b)"> <text>2 months before the period for which final Capital rates are being calculated, determine the most recent appraisal for each facility;</text> </paragraph> <paragraph num="(c)"> <text>Determine the cost report for each facility that covers the date of valuation of the appraisal identified in §B(1)(b) of this regulation, or, if a cost report covering the date of valuation has not been filed by the facility, determine the closest match to the date of valuation available 2 months before the period for which final Capital rates are being calculated;</text> </paragraph> <paragraph num="(d)"> <text>Multiply the ending licensed nursing facility beds from the cost report in §B(1)(c) of this regulation, adjusted for accuracy using information available 2 months before setting the rate in this regulation, by the land per bed amount from the appraisal to calculate a total land amount;</text> </paragraph> <paragraph num="(e)"> <text>Sum the total land amount, building, and equipment;</text> </paragraph> <paragraph num="(f)"> <text>Divide the total appraisal amount by the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine an appraised value per bed;</text> </paragraph> <paragraph num="(g)"> <text>Apply a maximum appraised value per bed of $120,000;</text> </paragraph> <paragraph num="(h)"> <text>Multiply the final appraised value per bed times the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine the facility’s gross value;</text> </paragraph> <paragraph num="(i)"> <text>For facilities in Baltimore City, multiply the facility’s gross value by 10 percent to determine the facility’s annual fair rental value;</text> </paragraph> <paragraph num="(j)"> <text>For facilities in all jurisdictions except Baltimore City, multiply the facility’s gross value by 8 percent to determine the facility’s annual fair rental value;</text> </paragraph> <paragraph num="(k)"> <text>Divide the facility’s annual fair rental value by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a fair rental value per diem rate;</text> </paragraph> <paragraph num="(l)"> <text>Divide real estate taxes obtained from the most recent desk reviewed cost report available 2 months before the start of the rate year by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a real estate tax per diem rate; and</text> </paragraph> <paragraph num="(m)"> <text>Sum the fair rental value and the real estate tax per diem rates.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The appraisal may not include any value associated with a Certificate of Need for nursing home beds.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The final Capital rate for nursing facilities that have a change in the number of licensed beds or have replacement beds placed into operation during a State fiscal year shall not be recalculated as a result of that change until such time as an appraisal incorporating the changes is selected according to §B(1)(b) of this regulation and used in the facility’s rate calculation.</text> </paragraph> <paragraph num="D."> <text>The provider may protest the appraisal by submitting written notification to the Department within 90 days of receipt of the appraisal. If the protest cannot be resolved administratively, the provider may appeal under Regulation .34 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows:</text> <paragraph num="(1)"> <text>Sum the assessed days reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the calendar year preceding the rate year;</text> </paragraph> <paragraph num="(2)"> <text>Multiply the assessed days by the assessment rate established for the rate quarters; and</text> </paragraph> <paragraph num="(3)"> <text>Divide the total assessed amount by the sum of the total patient days reported on the quarterly Nursing Facility Quality Assessment Payment Reporting Forms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Rate Calculation — Nursing Service Costs."> <paragraph num="A."> <text>The Nursing Service cost center includes all nursing expenses related to the direct provision of patient care.</text> </paragraph> <paragraph num="B."> <text>The Department shall initially establish Nursing Service prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Nursing Service prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps:</text> <paragraph num="(1)"> <text>The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Each cost report's indexed Nursing Service costs shall be divided by the actual days of nursing care to arrive at the indexed Nursing Service cost per diem;</text> </paragraph> <paragraph num="(3)"> <text>The indexed Nursing Service cost per diem shall be normalized to the Statewide average case mix index by multiplying the indexed Nursing Service cost per diem by the facility’s normalization ratio calculated as the Statewide average case mix index divided by the cost report period case mix index rounded to four decimals which creates the Normalized Nursing Cost per diem;</text> </paragraph> <paragraph num="(4)"> <text>For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of cost per diems identified in §B(3) of this regulation to calculate the Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>The final price for Nursing Service costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median Nursing Service cost multiplied by 1.0825; and</text> </paragraph> <paragraph num="(6)"> <text>For years between periods when the prices are rebased, the final price for Nursing Service costs shall be adjusted as set forth in Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The final Nursing Service rate for each nursing facility for each quarter is calculated as follows:</text> <paragraph num="(1)"> <text>Determine the Nursing Service price for the facility’s geographic region;</text> </paragraph> <paragraph num="(2)"> <text>Calculate an initial nursing facility rate by multiplying the price by the facility average Medicaid case mix index divided by the Statewide average case mix index;</text> </paragraph> <paragraph num="(3)"> <text>Calculate a Medicaid adjusted Nursing Service cost per diem by multiplying the per diem identified under §B(2) or C(5) of this regulation by the Medicaid case mix adjustment ratio calculated as the facility average Medicaid case mix index divided by the cost report period case mix index rounded to four decimals;</text> </paragraph> <paragraph num="(4)"> <text>Calculate the final Nursing Service rate as the initial nursing facility rate reduced by any positive difference between 95 percent of the initial nursing facility rate and the Medicaid adjusted Nursing Service cost per diem; and</text> </paragraph> <paragraph num="(5)"> <text>For years between periods when the prices are rebased, the indexed Nursing Service cost per diem identified under §B(2) of this regulation shall be adjusted as set forth in Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The reimbursement classes for the Nursing Service cost center are specified under Regulation .30C of this chapter.</text> </paragraph> <paragraph num="E."> <text>Resident Rosters.</text> <paragraph num="(1)"> <text>A nursing facility shall electronically transmit MDS assessment information in a complete, accurate, and timely manner.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall provide a preliminary resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter on the fifth day of the second month following the end of the calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 15th day following the end of the calendar quarter.</text> </paragraph> <paragraph num="(3)"> <text>The distribution of the preliminary resident roster shall serve as notice of the MDS assessments transmitted and provide an opportunity for the nursing facility to correct and transmit any missing MDS record.</text> </paragraph> <paragraph num="(4)"> <text>The Department shall provide a final resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 25th day of the second calendar month following the end of the calendar quarter.</text> </paragraph> <paragraph num="(5)"> <text>The Department may not consider MDS assessment information for the purpose of reimbursement rate calculations for a calendar quarter that is not submitted by the 25th day of the second calendar month following the end of the calendar quarter, except as provided in §E(6) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>The Department may only grant an exception to compliance with the electronic MDS assessment transmission due dates if the delay has been caused by fire, flood, act of God, or other good cause.</text> </paragraph> <paragraph num="(7)"> <text>The Department or its designated contractor shall distribute preliminary and final resident rosters according to the following schedule:</text> </paragraph> </paragraph> <paragraph num="F."> <text>Case Mix Index Calculation.</text> <paragraph num="(1)"> <text>The Department shall use the resource utilization group to adjust Nursing Service costs and to determine each nursing facility’s Nursing Service rate component.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall adjust a nursing facility's case mix reimbursement rates quarterly based on the change in case mix of each facility according to the following schedule:</text> <paragraph num="(a)"> <text>The facility average Medicaid case mix index obtained from January 1 through March 31 shall be used to adjust rates effective July 1 through September 30 of the same calendar year;</text> </paragraph> <paragraph num="(b)"> <text>The facility average Medicaid case mix index obtained from April 1 through June 30 shall be used to adjust rates effective October 1 through December 31 of the same calendar year;</text> </paragraph> <paragraph num="(c)"> <text>The facility average Medicaid case mix index obtained from July 1 through September 30 shall be used to adjust rates effective January 1 through March 31 of the following calendar year; and</text> </paragraph> <paragraph num="(d)"> <text>The facility average Medicaid case mix index obtained from October 1 through December 31 shall be used to adjust rates effective April 1 through June 30 of the following calendar year.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Department or its contractor determines that a nursing facility has delinquent MDS resident assessments, for purposes of determining both facility CMI averages, the assessments shall be assigned the case mix index associated with the RUG group “BC1” or its successor.</text> </paragraph> <paragraph num="(4)"> <text>A delinquent MDS shall be assigned a CMI value equal to the lowest CMI in the RUG classification system, or its successor.</text> </paragraph> <paragraph num="(5)"> <text>For each resident roster quarter, the Department shall calculate a Statewide average case mix index and a Statewide average Medicaid case mix index from all final resident rosters.</text> </paragraph> <paragraph num="(6)"> <text>A Medicaid case mix index equalizer shall be used to prevent any aggregate increase or decrease in expected State fiscal year Medicaid program expenditures for the rate quarters beginning every October, January and April, as follows:</text> <paragraph num="(a)"> <text>The Statewide average Medicaid case mix index for the July rate quarter shall be divided by the Statewide average Medicaid case mix index for the rate quarter identified in §F(2) of this regulation to determine the Medicaid case mix index equalizer for the quarter;</text> </paragraph> <paragraph num="(b)"> <text>Each facility average Medicaid case mix index for use in the rate quarter for each nursing facility shall be multiplied by the Medicaid case mix index equalizer to result in a facility Medicaid equalized case mix index; and</text> </paragraph> <paragraph num="(c)"> <text>The facility Medicaid equalized case mix index shall be used in place of the facility Medicaid case mix index in the calculation of the initial and final Nursing Service rate in §C of this regulation for every October, January, and April rate quarter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>To determine cost report period case mix index for cost reporting periods starting before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are used. If a cost report end date is before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are not used.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Assignment of Different Geographic Region.</text> <paragraph num="(1)"> <text>The Department may approve a provider's request to be included in a different Nursing Service cost center geographic region of this chapter upon review of sufficient documentation. Documentation shall show that the assigned geographic region is not appropriate for the provider and that economic conditions have placed the provider directly in competition with facilities in a geographic region other than the one to which the provider has been assigned by the Department. Payment of higher wages, or higher total expenditures, is not in itself sufficient to demonstrate that the provider is subject to economic conditions different from other providers in its reimbursement class.</text> </paragraph> <paragraph num="(2)"> <text>All approved waivers for geographic regions shall be effective for the following State fiscal year for the purpose of establishing the final Nursing Service rate in §C of this regulation,</text> </paragraph> <paragraph num="(3)"> <text>Nursing Service prices established in §B of this regulation shall be based on all facilities in a geographic region that do not have an approved waiver to be included in a different geographic region plus facilities with an approved waiver to receive prices in that geographic region.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Ventilator Care Nursing Facilities."> <text>Nursing facilities with licensed nursing facility beds, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as follows:</text> <paragraph num="A."> <text>Services for residents receiving ventilator care shall be reimbursed as follows:</text> <paragraph num="(1)"> <text>The Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that includes only residents receiving ventilator care; and</text> </paragraph> <paragraph num="(2)"> <text>An amount of $285 shall be added to the total prospective rate;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility average Medicaid case mix index for rates under §A of this regulation are not subject to the Medicaid case mix index equalizer adjustment in Regulation .12F(6) of this chapter;</text> </paragraph> <paragraph num="C."> <text>Nursing facilities adding ventilator care services for the first time, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as described in §A of this regulation, except that the facility average Medicaid case mix index is assumed to be that of RUG classification ES3 (or its future equivalent);</text> </paragraph> <paragraph num="D."> <text>The facility should request this rate from the Department at least 60 days before the opening of the ventilator unit;</text> </paragraph> <paragraph num="E."> <text>For years between periods when the Nursing Services prices are rebased, the final price for Ventilator costs shall be adjusted as set forth in Regulation .09D of this chapter; and</text> </paragraph> <paragraph num="F."> <text>For residents not receiving ventilator care, the Initial Facility Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that excludes residents receiving ventilator care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Pay-for-Performance — Eligibility."> <text>In order to be eligible to receive funds through the pay-for-performance program under the provisions of Regulations .15—.19 of this chapter:</text> <paragraph num="A."> <text>The provider shall be subject to quality assessment under COMAR 10.01.20; and</text> </paragraph> <paragraph num="B."> <text>During the 1 year period ending March 31 of the prior State fiscal year, the provider may not have been:</text> <paragraph num="(1)"> <text>Identified by the federal Centers for Medicare and Medicaid Services as a special focus facility;</text> </paragraph> <paragraph num="(2)"> <text>Denied payment for new admissions by the Department; or</text> </paragraph> <paragraph num="(3)"> <text>Identified by the Department as delivering substandard quality of care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Pay-for-Performance — Quality Measures."> <paragraph num="A."> <text>Providers shall receive a composite score based on the following:</text> <paragraph num="(1)"> <text>Staffing levels, as described in §B of this regulation, shall comprise 20 percent of each facility’s score;</text> </paragraph> <paragraph num="(2)"> <text>Staffing stability, as described in §C of this regulation, shall comprise 15 percent of each facility’s score;</text> </paragraph> <paragraph num="(3)"> <text>Maryland Health Care Commission Nursing Facility Family Survey, as described in §D of this regulation, shall comprise 30 percent of each facility’s score;</text> </paragraph> <paragraph num="(4)"> <text>Minimum Data Set Clinical Quality Indicators, as described in §E of this regulation, shall comprise 30 percent of each facility’s score; and</text> </paragraph> <paragraph num="(5)"> <text>Staff immunization survey, as described in §F of this regulation, shall comprise 5 percent of each facility’s score.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staffing Levels.</text> <paragraph num="(1)"> <text>Staffing and hours of work shall be determined using the Payroll-Based Journal data for the 9-month period ending March 31 of each fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>A facility’s average staffing level shall be determined from its most recent data reported in accordance with §B(1) of this regulation. Total staff hours shall be divided by average daily census during the period specified in §B(1) of this regulation to establish the facility’s average daily staffing.</text> </paragraph> <paragraph num="(3)"> <text>A facility’s average acuity shall be determined based on the facilities Minimum Data Set Resource Utilization Groups (RUG) during the 6-month period ending December 31 of the most recent State fiscal year. To establish expected staffing hours, each RUG group will be multiplied by the corresponding hours under Regulation .31B of this chapter and divided by the total days of care during the same period.</text> </paragraph> <paragraph num="(4)"> <text>The result from §B(3) of this regulation shall be multiplied by 1.26555 to establish the facility’s staffing goal.</text> </paragraph> <paragraph num="(5)"> <text>The facility’s staffing level from §B(2) of this regulation shall be divided by the facility’s staffing goal from §B(4) of this regulation to determine a score based on its percentage of the goal. A facility staffing exceeding its goal shall be scored at 100 percent.</text> </paragraph> <paragraph num="(6)"> <text>Providers shall receive 0—20 points based upon the scoring methodology described under Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff Stability.</text> <paragraph num="(1)"> <text>On or before May 31 of the fiscal year, nursing facilities, excluding continuing care retirement communities and facilities with fewer than 45 beds, shall report data on individual nursing staff members’ length of employment using a format and procedures designated by the Department. This data shall include all nursing staff employed by the facility during the pay period that includes March 31 of the fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>Providers that fail to comply with §C(1) of this regulation shall receive 0 points.</text> </paragraph> <paragraph num="(3)"> <text>Staff stability is based upon dates of employment for nursing staff reported in accordance with §C(1) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Staff stability shall be determined by the percentage of staff employed by the facility for 2 years or longer at the time of the report.</text> </paragraph> <paragraph num="(5)"> <text>Providers shall receive 0—15 points based upon the scoring methodology described under Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Family Satisfaction.</text> <paragraph num="(1)"> <text>Family satisfaction shall be determined based on results from the facility’s most recent Nursing Facility Family Survey administered by the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>Providers shall receive 0—30 points based upon the scoring methodology described under Regulation .16 of this chapter, as follows:</text> <paragraph num="(a)"> <text>0—6 points shall be based upon questions regarding general satisfaction; and</text> </paragraph> <paragraph num="(b)"> <text>0—24 points shall be based on several categories of questions regarding specific aspects of care and environment in the nursing facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Minimum Data Set Clinical Quality Indicators.</text> <paragraph num="(1)"> <text>Providers shall receive scores for the 3-month period ending December 31 of the most recent prior State fiscal year based on the following quality indicators for long-stay residents from the Minimum Data Set published by the federal Centers for Medicare and Medicaid Services:</text> <paragraph num="(a)"> <text>Percent of High-Risk Residents Who Have Pressure Sores;</text> </paragraph> <paragraph num="(b)"> <text>Percent of Residents with a Fall Resulting in Major Injury;</text> </paragraph> <paragraph num="(c)"> <text>Percent of Residents Who Have/Had a Catheter Inserted and Left in Their Bladder;</text> </paragraph> <paragraph num="(d)"> <text>Percent of Residents with a Urinary Tract Infection;</text> </paragraph> <paragraph num="(e)"> <text>Percent of Long-Stay Residents Given Influenza Vaccination During the Flu Season; and</text> </paragraph> <paragraph num="(f)"> <text>Percent of Long-Stay Residents Who Were Assessed and Given Pneumococcal Vaccination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Providers shall receive 0—5 points for each quality indicator based on the scoring methodology described under Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Staff Immunizations.</text> <paragraph num="(1)"> <text>Providers shall receive a score based on the percentage of nursing facility staff, which includes all staff classifications, that have been vaccinated against seasonal influenza.</text> </paragraph> <paragraph num="(2)"> <text>Providers shall receive 0, 2, or 5 points for this quality measure. Facilities shall submit data to the Department regarding all individuals employed or contracted by the facility during the period September through April 15.</text> </paragraph> <paragraph num="(3)"> <text>Benchmark.</text> <paragraph num="(a)"> <text>The benchmark for staff vaccinations is 90 percent.</text> </paragraph> <paragraph num="(b)"> <text>Nursing facilities that achieve the benchmark for at least 90 percent but less than 95 percent for seasonal flu shall receive 2 points.</text> </paragraph> <paragraph num="(c)"> <text>Nursing facilities that meet or exceed the benchmark of 95 percent for seasonal flu shall receive 5 points.</text> </paragraph> <paragraph num="(d)"> <text>Facilities with less than 90 percent may not receive points for this quality measure.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Pay-for-Performance — Scoring Methodology."> <paragraph num="A."> <text>Facilities that are eligible for pay-for-performance under Regulation .14 of this chapter shall receive a score for each quality measure described in Regulation .15 of this chapter.</text> </paragraph> <paragraph num="B."> <text>For the quality measures described in Regulation .15B—E of this chapter, a facility is ranked and awarded points as follows:</text> <paragraph num="(1)"> <text>The highest ranked facility receives 100 percent of the points available;</text> </paragraph> <paragraph num="(2)"> <text>The median score, weighted by total days of care, receives 50 percent of the points available;</text> </paragraph> <paragraph num="(3)"> <text>Zero points would be received by any facility whose raw score is below the median by an amount equal to or greater than the difference between the highest score and the median score; and</text> </paragraph> <paragraph num="(4)"> <text>All other facilities will receive points proportionate to where the score falls within the range between the highest and zero.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Points for each quality measure are summed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Pay-for-Performance — Payment for Improvement."> <paragraph num="A."> <text>In order to be eligible for improvement payment, a facility:</text> <paragraph num="(1)"> <text>Shall meet the eligibility criteria specified in Regulation .14 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall be eligible and receive a composite score during the current fiscal year and the prior fiscal year; and</text> </paragraph> <paragraph num="(3)"> <text>May not be receiving a payment based upon its score as described in Regulation .19C of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Facilities shall be ranked according to the greatest point increase compared with the prior fiscal year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Pay-for-Performance — Scoring Data Review."> <paragraph num="A."> <text>The Department shall report scores for pay-for-performance quality measures in Regulation .15 of this chapter, on or about July 1 of each year, based on data compiled during the prior fiscal year.</text> </paragraph> <paragraph num="B."> <text>A facility shall have 30 days from the date of the report to review and comment on performance data.</text> </paragraph> <paragraph num="C."> <text>If the Department determines that there are any errors in transcription of the data provided to the Department, or calculation of scores, ranks, or payment amounts, all facilities shall be rescored and revised scores shall be distributed. A final 30-day review period shall be allowed if the rescoring results in significant modifications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Pay-for-Performance — Payment Distribution."> <paragraph num="A."> <text>Beginning State fiscal year 2021, and each year thereafter, 1 percent of the budget allocation for nursing facility services shall be distributed based on pay-for-performance scores.</text> </paragraph> <paragraph num="B."> <text>Eighty-five percent of the amount identified in §A of this regulation shall be distributed to the highest scoring facilities, representing 40 percent of the eligible days of care, in accordance with the methodology described in Regulation .16 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Funds shall be distributed among the facilities identified in §B of this regulation, based on the facility’s relative score, such that the highest-scoring facility shall receive twice the amount per day as the lowest-scoring facility receiving payment.</text> </paragraph> <paragraph num="D."> <text>Fifteen percent of the amount identified in §A of this regulation shall be distributed to the facilities that qualify for payment for improvement in accordance with Regulation .17 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Funds shall be distributed among the facilities included in §D of this regulation, based on a facility’s relative point increase from the prior fiscal year, such that the facility with the greatest point increase shall receive twice the amount per day as the facility with the smallest point increase.</text> </paragraph> <paragraph num="F."> <text>A facility shall receive a lump-sum payment based on the per diem amount determined in accordance with §C or E of this regulation, multiplied by the facility’s Medicaid days of care in the facility’s most recent cost report, not to exceed 1 year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Payment Procedures — Out-of-State Facilities."> <paragraph num="A."> <text>Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do not meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed at a rate that is the lesser of:</text> <paragraph num="(1)"> <text>The average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment; and</text> </paragraph> <paragraph num="(2)"> <text>The out-of-State facility’s Medicaid per diem rate provided by the state in which the facility is located, or, if the state provides the facility with more than one Medicaid per diem rate, the facility’s lowest per diem rate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed the average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment.</text> </paragraph> <paragraph num="C."> <text>Out-of-State special rehabilitation nursing facilities shall be reimbursed by the Program when the following conditions are met:</text> <paragraph num="(1)"> <text>The facility is accredited by the Commission on Accreditation of Rehabilitation Facilities;</text> </paragraph> <paragraph num="(2)"> <text>The facility is licensed and certified as a nursing facility; and</text> </paragraph> <paragraph num="(3)"> <text>Services for which reimbursement is requested have been preauthorized by the Program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The rate for each resident in an out-of-State special rehabilitation nursing facility shall be negotiated to:</text> <paragraph num="(1)"> <text>Be less than the cost of available institutional alternatives; and</text> </paragraph> <paragraph num="(2)"> <text>Not exceed the home state's Medicaid rate for the same service by the same provider if the provider participates in its home state Medicaid program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Cost Reporting."> <paragraph num="A."> <text>The provider shall include, for purposes of cost finding, direct and indirect costs applicable to recipient care.</text> </paragraph> <paragraph num="B."> <text>The provider shall specifically identify, in the cost report, costs associated with related organizations.</text> </paragraph> <paragraph num="C."> <text>The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts will provide as a minimum:</text> <paragraph num="(1)"> <text>Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements;</text> </paragraph> <paragraph num="(2)"> <text>Proper reference to supporting invoice, voucher, or other form of original evidence;</text> </paragraph> <paragraph num="(3)"> <text>Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers;</text> </paragraph> <paragraph num="(4)"> <text>Provision for payment by check (when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained);</text> </paragraph> <paragraph num="(5)"> <text>Maintenance of records on all assets capitalized and depreciation on the assets;</text> </paragraph> <paragraph num="(6)"> <text>Maintenance of appropriate records of patient days by level of care;</text> </paragraph> <paragraph num="(7)"> <text>Maintenance of records on an accrual basis;</text> </paragraph> <paragraph num="(8)"> <text>Maintenance of a daily midnight bed census by recipient name in a form prescribed by the Department (use of the prescribed form may be waived by the Department or its designee where a provider demonstrates the ability to maintain a superior system of census information); and</text> </paragraph> <paragraph num="(9)"> <text>Maintenance of other records as required by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Upon request by the Department or its designee, documentation of costs shall be made available by the provider during the course of verification. The provider shall have 30 days from the date of the request to provide documentation for undocumented costs. Costs for which documentation is not provided within the 30 days shall be deemed not allowable. The Department may grant, in writing, an extension of time upon written demonstration by the provider of good cause. Records shall be retained for 6 years after the month the cost report to which the materials apply is filed with the Department or its designee.</text> </paragraph> <paragraph num="E."> <text>Financial and Statistical Data Required.</text> <paragraph num="(1)"> <text>The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="(2)"> <text>If reports are not received within 3 months and an extension has not been granted, the Department shall reduce the per diem rate by 3 percent for services provided during the calendar month after the month in which the report is due and any subsequent calendar month through the month during which the report has been submitted.</text> </paragraph> <paragraph num="(3)"> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="(4)"> <text>A 1-month extension will be granted upon written request in advance by the provider. The Department may not grant an extension longer than 1 month unless the delay in filing the report has been caused by fire, flood, or act of God, and an extension is not allowed past March 31 after the calendar year during which the provider's fiscal year ended unless the report cannot be submitted by that date due to fire, flood, or act of God.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When a report is not submitted by the last day of the sixth month after the end of the provider's fiscal year, the Department shall impose one or more sanctions as provided for in Regulation .33 of this chapter.</text> </paragraph> <paragraph num="G."> <text>For purposes of §§E and F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="I."> <text>The Department, at its option, may request an additional cost report from a provider when a:</text> <paragraph num="(1)"> <text>Change in the location of a provider's operation occurs; or</text> </paragraph> <paragraph num="(2)"> <text>Significant change occurs that would affect the appraised value of a facility, such as an increase in the number of beds by more than 10 percent.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If the Department exercises its option under the provisions of §I of this regulation, the period covered by the two reports in the specific provider’s fiscal year shall be divided as follows:</text> <paragraph num="(1)"> <text>Beginning of fiscal year to date of change; and</text> </paragraph> <paragraph num="(2)"> <text>Date of change through the end of the fiscal year.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Except as indicated in §L of this regulation, administrative and routine, other patient care, and capital costs incurred by the provider exclusively for providing ventilator care are not allowed in these cost centers, but are allowable nursing service costs.</text> </paragraph> <paragraph num="L."> <text>For any provider who provides ventilator care on 50 percent or more of its Maryland Medical Assistance days of care, all costs incurred by the provider exclusively for providing ventilator care are not allowable costs.</text> </paragraph> <paragraph num="M."> <text>A provider which renders a minimal number of Maryland Medical Assistance days of care may not be subject to cost reporting or field verification requirements for a specified fiscal period when the following criteria are met:</text> <paragraph num="(1)"> <text>The provider bills the Maryland Medical Assistance Program for less than 1,000 Maryland Medical Assistance days of care during the provider's fiscal period; and</text> </paragraph> <paragraph num="(2)"> <text>The provider gives notice to the Program within 3 months after the end of the provider's fiscal period of the intent to not file a cost report for that period.</text> </paragraph> </paragraph> <paragraph num="N."> <text>The notice required in §M(2) of this regulation shall include:</text> <paragraph num="(1)"> <text>An assurance that the provider billed the Medical Assistance Program for less than 1,000 days of care in the fiscal period; and</text> </paragraph> <paragraph num="(2)"> <text>A statement that the provider agrees to accept as final reimbursement the average rate paid to all other nursing facilities in the facility’s geographic region identified in Regulation .30A of this chapter, minus the quality assessment add-on for facilities that are exempt from Nursing Facility Quality Assessment identified in COMAR 10.01.20.</text> </paragraph> </paragraph> <paragraph num="O."> <text>A provider that does not incur costs for over-the-counter drugs on behalf of its private pay residents may adjust its report in order to ensure final reimbursement that more accurately reflects its costs for Medicaid days of care. The provider shall divide its costs by Medicaid and other government-paid days, multiply the quotient by its private pay days of care, and report the product as an adjustment to its over-the-counter drug costs.</text> </paragraph> <paragraph num="P."> <text>Out-of-State facilities are not subject to cost reporting requirements</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Desk Reviews and Field Verification."> <paragraph num="A."> <text>Desk Reviews.</text> <paragraph num="(1)"> <text>The Department or its designee may conduct a desk review of the costs before establishing the Administrative and Routine and Other Patient Care prices and Nursing Service rates.</text> </paragraph> <paragraph num="(2)"> <text>The Department or its designee shall notify each provider participating in the Program if any adjustments resulted from the desk review.</text> </paragraph> <paragraph num="(3)"> <text>Desk review adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Field Verifications.</text> <paragraph num="(1)"> <text>The Department or its designee may conduct a field verification of the reported or desk reviewed costs affecting reimbursement rates.</text> </paragraph> <paragraph num="(2)"> <text>The Department or its designee shall notify each provider participating in the Program of the results of the field verification.</text> </paragraph> <paragraph num="(3)"> <text>Field audit adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased.</text> </paragraph> <paragraph num="(4)"> <text>Field audit adjustments shall be used in the recomputation of any past rate for the facility or the facility’s past owner that is based on the reported or desk reviewed costs.</text> </paragraph> <paragraph num="(5)"> <text>If the recomputation of rates results in a rate that differs more than 2 percent from the initial rate computation excluding the quality assessment, the Department shall initiate an adjustment for the impacted service dates within 60 days after the notification described in §B(2) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>Field audit adjustments shall only affect the facility’s rates and do not affect prices or rates for other facilities within the geographic region.</text> </paragraph> <paragraph num="(7)"> <text>Out-of-State facilities are not subject to field verification requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Third Party Liability Reviews and Audits of Nursing Facilities."> <paragraph num="A."> <text>Quarterly Reports of Credit Balances. A provider shall report the credit balances of the nursing facility to the Department on a quarterly basis.</text> </paragraph> <paragraph num="B."> <text>Third Party Liability Review. The Department shall conduct a third party liability review of the reports of the credit balances provider under §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>Third Party Liability Audit of Random Sample. The Department or its designee may conduct a third party liability audit of a random sample of the reports of credit balances reviewed under §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Third Party Liability Audit of Noncompliant Nursing Facility.</text> <paragraph num="(1)"> <text>Subject to §D(2) of this regulation, the Department or its designee may conduct a third party liability audit of a nursing facility that is found to be noncompliant under §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>In conducting the third party liability audit, the Department or its designee may only review the financial information of the nursing facility for the 2-year period immediately before the first day of the audit period in which the nursing facility was found to be noncompliant.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Appeal Rights of Nursing Facility.</text> <paragraph num="(1)"> <text>A provider may appeal the results of a final report of a third party liability audit by filing written notice with the Department within 30 days after the provider receives the final report from the Department.</text> </paragraph> <paragraph num="(2)"> <text>An individual at the Department who did not participate in the final report shall:</text> <paragraph num="(a)"> <text>Review the appeal and contact a provider representative, if clarification is necessary; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a report that either revises or concurs with the final report of the third party audit.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A provider may appeal the results of the report issued by the Department under §E(2) of this regulation by filing written notice with the Nursing Home Appeal Board within 30 days of receipt of the report.</text> </paragraph> <paragraph num="(4)"> <text>If the provider does not appeal the results of the third party liability audit by filing written notice with the Department:</text> <paragraph num="(a)"> <text>The amount due as set out in the final report shall be paid to the Department within 60 days of the receipt by the provider of the results of the third party liability audit; or</text> </paragraph> <paragraph num="(b)"> <text>On or after the 61st day, after receipt by the provider of the results of the third party liability audit, the Department may withhold the amount as set out in the final report from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the provider appeals the results of a final report of a third party liability audit as authorized under §E(1) of this regulation, interest shall be charged on the amount appealed and shall continue until date of payment. The interest rate shall be based on the 6-month Treasury Bill rate in effect on the date the appeal was filed.</text> </paragraph> <paragraph num="(6)"> <text>After a decision adverse to the provider by the Nursing Home Appeal Board and written notice to the provider of that decision by the Department:</text> <paragraph num="(a)"> <text>The amount determined to be due to the Department as a result of the third party liability audit shall be paid to the Department with accrued interest due; or</text> </paragraph> <paragraph num="(b)"> <text>On or after the 61st day, the Department may withhold the amount due pursuant to the decision of the Nursing Home Appeal Board from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="MDS Validation and Ventilator Care Validation."> <paragraph num="A."> <text>MDS Validation.</text> <paragraph num="(1)"> <text>In order to validate that the Nursing Service rate is supported by medical record documentation, accurately coded and submitted, the Department shall conduct periodic MDS validation reviews, which shall:</text> <paragraph num="(a)"> <text>Compare the MDS assessment coding with the corresponding medical record documentation to determine unsupported MDS assessments;</text> </paragraph> <paragraph num="(b)"> <text>Determine the completeness, timeliness, and accuracy of resident MDS assessments identified on the resident roster; and</text> </paragraph> <paragraph num="(c)"> <text>Determine the completeness and accuracy of the resident payment source listed on the resident roster.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Findings from the MDS validation may be used to adjust a nursing facility’s per diem payment rate to reflect the validated case mix index used in the rate setting process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Ventilator Care Validation.</text> <paragraph num="(1)"> <text>In order to validate that days paid for residents that meet the requirements for ventilator care are supported by medical record documentation of the need for ventilator care services, the Department shall conduct a periodic ventilator care validation.</text> </paragraph> <paragraph num="(2)"> <text>Findings from the ventilator care validation shall be used to recoup payments for days not supported by medical record documentation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="New Nursing Facilities, Replacement Facilities, and Change of Ownership."> <paragraph num="A."> <text>The Department shall establish rates for new nursing facilities, replacement facilities, and nursing facilities with a change of ownership as outlined in §§B—D of this regulation.</text> </paragraph> <paragraph num="B."> <text>New Nursing Facilities.</text> <paragraph num="(1)"> <text>Until such time as an appraisal for the new facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A new nursing facility shall be assigned the Statewide average Medicaid CMI until assessment data submitted by the nursing facility is used in a quarterly rate determination.</text> </paragraph> <paragraph num="(3)"> <text>The nursing facility shall be assigned to the appropriate geographic region, as specified under Regulation .30 of this chapter, for purposes of assigning the Nursing Service rate, the Other Patient Care price, and the Administrative and Routine price.</text> </paragraph> <paragraph num="(4)"> <text>The geographic region price for Nursing Service costs shall be multiplied by the new nursing facility’s Medicaid CMI until there is a nursing facility cost report used in the rebasing process.</text> </paragraph> <paragraph num="(5)"> <text>The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter and the maximum bed value identified in Regulation .11B(1)(g) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent.</text> </paragraph> <paragraph num="(6)"> <text>Upon providing the real estate bills to the State which incorporate the new construction at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent.</text> </paragraph> <paragraph num="(7)"> <text>For the first 2 State fiscal rate setting years, or portions thereof, new nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows:</text> <paragraph num="(a)"> <text>Estimate the assessed days to be reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the upcoming State fiscal rate setting year or portion thereof;</text> </paragraph> <paragraph num="(b)"> <text>Multiply the estimated assessed days by the assessment rate anticipated for the rate quarters; and</text> </paragraph> <paragraph num="(c)"> <text>Divide the total estimated assessed amount by the sum of the total estimated patient days. At the completion of either of these first two rate setting periods, either the State or the facility may initiate a settlement payment should the estimates vary from the actual by more than 10 percent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Replacement Facilities.</text> <paragraph num="(1)"> <text>Until such time as an appraisal for the replacement facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated as the Statewide average under Regulation .09B(4) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent.</text> </paragraph> <paragraph num="(3)"> <text>Upon providing the real estate bills to the State, which incorporate the new construction, at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent.</text> </paragraph> <paragraph num="(4)"> <text>The replacement facility fair rental value rate shall be effective beginning on the date the replacement facility meets the requirements in Regulations .02 and .03 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>Except for the fair rental value portion of the Capital rate, the replacement facility shall be paid exactly as the original facility.</text> </paragraph> <paragraph num="(6)"> <text>The replacement facility rates shall be based on the original facility’s average Medicaid case mix index and cost report costs.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Change of Ownership.</text> <paragraph num="(1)"> <text>Except when the Program agrees to a shorter notification period, when there is an anticipated change of ownership of a provider, not less than 30 days before the date of the change of ownership:</text> <paragraph num="(a)"> <text>The provider shall:</text> <paragraph num="(i)"> <text>Notify the Program of the anticipated change of ownership; and</text> </paragraph> <paragraph num="(ii)"> <text>If the provider has not filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The purchaser shall:</text> <paragraph num="(i)"> <text>Notify the Program of the intent to engage in a change of ownership and the desire to enroll in the Program;</text> </paragraph> <paragraph num="(ii)"> <text>Submit a provider application and execute a provider agreement with the Department; and</text> </paragraph> <paragraph num="(iii)"> <text>If the provider has filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Indemnity Bond or Standby Letter of Credit.</text> <paragraph num="(a)"> <text>The indemnity bond or standby letter of credit required by §D(1)(a)(ii) or (b)(iii) of this regulation shall be in the amount of:</text> <paragraph num="(i)"> <text>10 percent of the Program billings for each unsettled fiscal period prior to January 1, 2015 outstanding;</text> </paragraph> <paragraph num="(ii)"> <text>All unpaid amounts due and owing the Program for each settled fiscal period before January 1, 2015;</text> </paragraph> <paragraph num="(iii)"> <text>5 percent of the Program billings for the most recent annual fiscal period; and</text> </paragraph> <paragraph num="(iv)"> <text>All debt owed by the provider to the Interim Working Capital Fund under Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The indemnity bond or standby letter of credit obligation under §D(2)(a) of this regulation shall remain in effect until all financial liabilities are resolved.</text> </paragraph> <paragraph num="(c)"> <text>If a court of competent jurisdiction discharges the debt of a bankrupt provider, the Program shall release to the purchaser the difference between the indemnity bond or standby letter of credit required under §D(1)(b)(iii) of this regulation and the amount of the financial obligation discharged by the court.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The purchaser shall submit a provider application and execute a provider agreement with the Department before being assigned a prospective rate.</text> </paragraph> <paragraph num="(4)"> <text>The new owner shall assume the old owner’s facility average Medicaid case mix index and cost reports.</text> </paragraph> <paragraph num="(5)"> <text>The new owner shall be paid at the same rates as the old nursing facility provider except for the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter in which the Capital rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Selected Costs — Allowable."> <paragraph num="A."> <text>Recreational Services. The allowable costs of recreational services of a facility shall be based on an hourly or salary rate, not on a fee-for-service basis.</text> </paragraph> <paragraph num="B."> <text>Over-the-Counter Drugs. The cost of over-the-counter drugs is not to exceed the average wholesale price plus 50 percent, or the usual selling price, whichever is lower.</text> </paragraph> <paragraph num="C."> <text>Leave of Absence. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, less patient resources for the cost of reserving beds for recipients for therapeutic home visits or participation in State-approved therapeutic or rehabilitative programs, subject to the following conditions:</text> <paragraph num="(1)"> <text>The recipient's plan of care provides for the absence;</text> </paragraph> <paragraph num="(2)"> <text>The leave of absence does not exceed 18 days during any calendar year;</text> </paragraph> <paragraph num="(3)"> <text>The recipient's attending physician shall complete the physician's authorization form not more than 30 days before the recipient's anticipated leave of absence; and</text> </paragraph> <paragraph num="(4)"> <text>The facility submits the physician's authorization form to the Department with the facility's invoice, which covers the month in which the leave of absence occurred.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Administrative Days. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, and 50 percent of the rate identified in Regulation .12 of this chapter, less patient resources for administrative days, documented on forms designated by the Department, which satisfy the following conditions:</text> <paragraph num="(1)"> <text>The recipient’s required level of care has changed, and the following conditions are met:</text> <paragraph num="(a)"> <text>The Department or its designee has determined that the recipient’s level of care is provided by an Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID);</text> </paragraph> <paragraph num="(b)"> <text>The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time;</text> </paragraph> <paragraph num="(c)"> <text>The provider has actively pursued placement of the recipient at the required level of care in an appropriate facility during the entire period of administrative days;</text> </paragraph> <paragraph num="(d)"> <text>The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(1)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and</text> </paragraph> <paragraph num="(e)"> <text>The recipient is transferred promptly to the first available appropriate facility licensed and certified for the required level of care;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When institutional care is no longer appropriate, and the following conditions are met:</text> <paragraph num="(a)"> <text>The Department or its designee has determined that the recipient no longer requires the level of care, which is provided by a nursing facility or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID);</text> </paragraph> <paragraph num="(b)"> <text>The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time;</text> </paragraph> <paragraph num="(c)"> <text>The provider has actively pursued placement of the recipient at the required level of care at home or in an appropriate setting during the entire period of administrative days;</text> </paragraph> <paragraph num="(d)"> <text>The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(2)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and</text> </paragraph> <paragraph num="(e)"> <text>The recipient is transferred promptly after appropriate placement has been found; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the recipient is at an inappropriate level of care but cannot be moved, and the following conditions are met:</text> <paragraph num="(a)"> <text>The attending physician has declared that, because of physical or emotional problems, the recipient is unable to be moved;</text> </paragraph> <paragraph num="(b)"> <text>The reason the recipient cannot be moved is adequately documented by the attending physician in the recipient's record; and</text> </paragraph> <paragraph num="(c)"> <text>Reevaluation by the attending physician of the recipient's inability to be moved and appropriate documentation of it in the recipient's record have been made at least every 60 days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Bed Occupancy. The Statewide average occupancy, defined in Regulation .09B(4) of this chapter, shall be calculated after the exclusion of all providers which operated under a waiver of the occupancy standard during any part of the cost report period.</text> </paragraph> <paragraph num="F."> <text>A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may be made by the Department under the following conditions:</text> <paragraph num="(1)"> <text>During a period not to exceed the first 12 months of operation for a newly constructed facility or for a newly constructed portion of an existing facility;</text> </paragraph> <paragraph num="(2)"> <text>During periods throughout which the occupancy standard could not be attained due to labor strike, fire, flood, or act of God, when this event is reported to the State licensing authority within 10 days of the event and request for waiver is submitted to the Program within 30 days of the event;</text> </paragraph> <paragraph num="(3)"> <text>For a period not to exceed 12 months when a voluntary reduction in licensed nursing facility bed capacity has been granted by the Department and the provider has received prior approval from the Program to reduce available beds while renovations are being completed;</text> </paragraph> <paragraph num="(4)"> <text>For a period not to exceed 12 months after a new provider acquires an existing facility which has been operated by the previous provider below the occupancy standard due to a ban on admissions, and when prior approval for the waiver has been granted by the Program;</text> </paragraph> <paragraph num="(5)"> <text>For a period not to exceed 12 months after a new provider acquires an existing facility which was in bankruptcy and operated below the occupancy standard at the time of purchase; or</text> </paragraph> <paragraph num="(6)"> <text>For a period not to exceed 12 months after a new provider has acquired or leased a building that was not licensed as a nursing facility immediately before the provider's acquisition or lease.</text> </paragraph> </paragraph> <paragraph num="G."> <text>When a waiver is granted under the provisions of §F(3) of this regulation, the occupancy standards shall be applied to the reduced licensed capacity.</text> </paragraph> <paragraph num="H."> <text>A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may not be allowed due to a ban on admissions or under any circumstances other than those described in §F of this regulation.</text> </paragraph> <paragraph num="I."> <text>Rates that are determined in accordance with the provisions of §F of this regulation are effective only for the period during which the waiver of the occupancy standard is in effect.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Selected Costs — Not Allowable."> <text>The following costs are not allowable in establishing prospective rates:</text> <paragraph num="A."> <text>Costs not adequately documented;</text> </paragraph> <paragraph num="B."> <text>Costs for chaplaincy training and other religious training programs;</text> </paragraph> <paragraph num="C."> <text>Bad debts incurred by private pay or Medicare patients or third-party payers and bad debts resulting from denied costs of the Program;</text> </paragraph> <paragraph num="D."> <text>Recipient resources certified as available for medical and remedial care by the Department of Human Services which are uncollected;</text> </paragraph> <paragraph num="E."> <text>Advertising expenses, except those necessary for personnel recruitment;</text> </paragraph> <paragraph num="F."> <text>Stockholder costs incurred primarily for the benefit of stockholders or other investors, including the costs of stockholders' annual reports and newsletters, annual meetings, mailing of proxies, stock transfer agent fees, stock exchange registration fees, stockbroker and investment analysis, stock issuance costs, and accounting and legal fees for consolidating statements for Securities and Exchange Commission purposes;</text> </paragraph> <paragraph num="G."> <text>Any contributions, whether charitable or not, to any individual or organization;</text> </paragraph> <paragraph num="H."> <text>Public relations expenses;</text> </paragraph> <paragraph num="I."> <text>Costs of maintaining a recipient in a private room which exceeds costs of a semiprivate room;</text> </paragraph> <paragraph num="J."> <text>Cost of depreciable assets and minor equipment useful for a lifetime of at least 2 years, with a historical cost of at least $500 or an aggregate historical cost of at least $500 if they are purchased in a quantity of like or similar items;</text> </paragraph> <paragraph num="K."> <text>Civil money penalties, fines, and all costs associated with sanctions, including receivership, initiated by the Department or any other local, State, or federal government agency;</text> </paragraph> <paragraph num="L."> <text>Interest paid by a provider under Regulation .23E(5) of this chapter;</text> </paragraph> <paragraph num="M."> <text>Administrator compensation for any owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows:</text> <paragraph num="(1)"> <text>For facilities with 1—74 beds, the median compensation from that group;</text> </paragraph> <paragraph num="(2)"> <text>For facilities with 75—199 beds, the median compensation from that group; and</text> </paragraph> <paragraph num="(3)"> <text>For facilities with 200 or more beds, the median compensation from all facilities with 200 or more beds;</text> </paragraph> </paragraph> <paragraph num="N."> <text>Compensation for any administrator, who is not an owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows:</text> <paragraph num="(1)"> <text>For facilities with 1—74 beds, the 75th percentile compensation from that group plus 15 percent;</text> </paragraph> <paragraph num="(2)"> <text>For facilities with 75—199 beds, the 75th percentile compensation from that group plus 15 percent;</text> </paragraph> <paragraph num="(3)"> <text>For facilities with 200—299 beds, the 75th percentile compensation from all facilities with 200 or more beds plus 15 percent; and</text> </paragraph> <paragraph num="(4)"> <text>For facilities with 300 or more beds, 15 percent more than the limit established in §N(3) of this regulation for the facilities with 200—299 beds;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Assistant administrator compensation for any owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §M of this regulation;</text> </paragraph> <paragraph num="P."> <text>Compensation for any assistant administrator, who is not an owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §N of this regulation;</text> </paragraph> <paragraph num="Q."> <text>Central office employee compensation for any owner or relative of the owner in excess of the amount established in accordance with §M of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent;</text> </paragraph> <paragraph num="R."> <text>Compensation for any central office employee, who is not an owner, or relative of the owner, in excess of the amount established in accordance with §N of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent;</text> </paragraph> <paragraph num="S."> <text>Costs incurred in any effort to acquire a Certificate of Need or an exemption from a Certificate of Need for nursing home beds;</text> </paragraph> <paragraph num="T."> <text>Costs incurred for specialized support surfaces used for pressure ulcer care;</text> </paragraph> <paragraph num="U."> <text>Legal, accounting, and other professional expenses related to an appeal challenging a payment determination pursuant to Regulations .23E and .34 of this chapter unless a final adjudication is issued sustaining the nursing facility's appeal;</text> </paragraph> <paragraph num="V."> <text>A percentage of the legal, accounting, and other professional expenses related to an appeal as described in §U of this regulation, based upon the proportion of additional reimbursement denied to the total additional reimbursement sought on appeal, if a facility prevails on some but not all issues raised in the appeal or action;</text> </paragraph> <paragraph num="W."> <text>Any charges assessed by the Department for recovery of overpayments; and</text> </paragraph> <paragraph num="X."> <text>Direct service costs for physical, occupational, and speech therapy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Recipient's Resource."> <paragraph num="A."> <text>The Department of Human Services will determine the application of a recipient's resource to the cost of medical or remedial care pursuant to COMAR 10.09.24.</text> </paragraph> <paragraph num="B."> <text>The provider shall collect a recipient's resource available for medical or remedial care, as certified by the Department of Human Services.</text> </paragraph> <paragraph num="C."> <text>The total of a recipient's available resource for medical or remedial care and the Department's payment may not exceed the provider's per diem rate.</text> </paragraph> <paragraph num="D."> <text>The provider shall show sums collected from a recipient's available resource as patient revenue.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Recipient's Personal Needs Fund."> <paragraph num="A."> <text>If a provider administers a recipient's personal needs fund, it shall administer the fund according to guidelines established by the Department.</text> </paragraph> <paragraph num="B."> <text>Upon request during normal business hours, a provider shall make available for verification by the Department or its designee the records of all transactions involving recipient's personal needs funds.</text> </paragraph> <paragraph num="C."> <text>A provider may not use a recipient's personal needs fund for care or services which are either allowable as part of the per diem cost or otherwise covered by the Medical Assistance Program.</text> </paragraph> <paragraph num="D."> <text>Upon request during normal business hours, 7 days a week, for a minimum of 3 hours each day, a provider shall allow a recipient to withdraw or otherwise use his personal needs fund.</text> </paragraph> <paragraph num="E."> <text>A provider may not use a recipient's personal needs fund for care or services not requested or not provided. A recipient's personal needs fund may not be used to retire a pre-existing debt.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Reimbursement Classes."> <paragraph num="A."> <text>The reimbursement classes for the Administrative and Routine cost center are as follows:</text> <paragraph num="(1)"> <text>Facilities in the Baltimore metropolitan region consisting of the following counties:</text> <paragraph num="(a)"> <text>Anne Arundel;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore;</text> </paragraph> <paragraph num="(c)"> <text>Carroll;</text> </paragraph> <paragraph num="(d)"> <text>Harford; and</text> </paragraph> <paragraph num="(e)"> <text>Howard;</text> </paragraph> </paragraph> <paragraph num="(1-1)"> <text>Facilities in Baltimore City;</text> </paragraph> <paragraph num="(2)"> <text>Facilities in the Washington region consisting of the following counties:</text> <paragraph num="(a)"> <text>Charles;</text> </paragraph> <paragraph num="(b)"> <text>Montgomery; and</text> </paragraph> <paragraph num="(c)"> <text>Prince George's;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Facilities in the nonmetropolitan region consisting of the following counties:</text> <paragraph num="(a)"> <text>Allegany;</text> </paragraph> <paragraph num="(b)"> <text>Calvert;</text> </paragraph> <paragraph num="(c)"> <text>Caroline;</text> </paragraph> <paragraph num="(d)"> <text>Cecil;</text> </paragraph> <paragraph num="(e)"> <text>Dorchester;</text> </paragraph> <paragraph num="(f)"> <text>Frederick;</text> </paragraph> <paragraph num="(g)"> <text>Garrett;</text> </paragraph> <paragraph num="(h)"> <text>Kent;</text> </paragraph> <paragraph num="(i)"> <text>Queen Anne's;</text> </paragraph> <paragraph num="(j)"> <text>St. Mary's;</text> </paragraph> <paragraph num="(k)"> <text>Somerset;</text> </paragraph> <paragraph num="(l)"> <text>Talbot;</text> </paragraph> <paragraph num="(m)"> <text>Washington;</text> </paragraph> <paragraph num="(n)"> <text>Wicomico; and</text> </paragraph> <paragraph num="(o)"> <text>Worcester.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The reimbursement classes for the Other Patient Care cost center are based on the county groupings as specified in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>For services provided prior to July 1, 2019, the reimbursement classes for the Nursing Service cost center are as follows:</text> <paragraph num="(1)"> <text>Facilities in the Baltimore region consisting of Baltimore City and Baltimore County;</text> </paragraph> <paragraph num="(2)"> <text>Facilities in the Central Maryland region consisting of the following counties:</text> <paragraph num="(a)"> <text>Anne Arundel;</text> </paragraph> <paragraph num="(b)"> <text>Carroll; and</text> </paragraph> <paragraph num="(c)"> <text>Howard;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Facilities in the Washington region consisting of the following counties:</text> <paragraph num="(a)"> <text>Charles;</text> </paragraph> <paragraph num="(b)"> <text>Frederick;</text> </paragraph> <paragraph num="(c)"> <text>Montgomery; and</text> </paragraph> <paragraph num="(d)"> <text>Prince George's;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Facilities in the nonmetropolitan region consisting of the following counties:</text> <paragraph num="(a)"> <text>Calvert;</text> </paragraph> <paragraph num="(b)"> <text>Caroline;</text> </paragraph> <paragraph num="(c)"> <text>Cecil;</text> </paragraph> <paragraph num="(d)"> <text>Dorchester;</text> </paragraph> <paragraph num="(e)"> <text>Harford;</text> </paragraph> <paragraph num="(f)"> <text>Kent;</text> </paragraph> <paragraph num="(g)"> <text>Queen Anne's;</text> </paragraph> <paragraph num="(h)"> <text>St. Mary's;</text> </paragraph> <paragraph num="(i)"> <text>Somerset;</text> </paragraph> <paragraph num="(j)"> <text>Talbot;</text> </paragraph> <paragraph num="(k)"> <text>Wicomico; and</text> </paragraph> <paragraph num="(l)"> <text>Worcester;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Facilities in the Western Maryland region consisting of the following counties:</text> <paragraph num="(a)"> <text>Allegany;</text> </paragraph> <paragraph num="(b)"> <text>Garrett; and</text> </paragraph> <paragraph num="(c)"> <text>Washington.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Effective July 1, 2020, the reimbursement classes for the Nursing Service cost center are as follows:</text> <paragraph num="(1)"> <text>Facilities in the Baltimore Metro region consisting of Baltimore City and the following counties:</text> <paragraph num="(a)"> <text>Anne Arundel;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore;</text> </paragraph> <paragraph num="(c)"> <text>Carroll;</text> </paragraph> <paragraph num="(d)"> <text>Cecil;</text> </paragraph> <paragraph num="(e)"> <text>Harford; and</text> </paragraph> <paragraph num="(f)"> <text>Howard;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Facilities in the Washington Metro region consisting of the following counties:</text> <paragraph num="(a)"> <text>Calvert;</text> </paragraph> <paragraph num="(b)"> <text>Charles;</text> </paragraph> <paragraph num="(c)"> <text>Frederick;</text> </paragraph> <paragraph num="(d)"> <text>Montgomery;</text> </paragraph> <paragraph num="(e)"> <text>Prince George’s; and</text> </paragraph> <paragraph num="(f)"> <text>St. Mary’s;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Facilities in the Eastern region consisting of the following counties:</text> <paragraph num="(a)"> <text>Caroline;</text> </paragraph> <paragraph num="(b)"> <text>Dorchester;</text> </paragraph> <paragraph num="(c)"> <text>Kent;</text> </paragraph> <paragraph num="(d)"> <text>Queen Anne’s;</text> </paragraph> <paragraph num="(e)"> <text>Somerset;</text> </paragraph> <paragraph num="(f)"> <text>Talbot;</text> </paragraph> <paragraph num="(g)"> <text>Wicomico; and</text> </paragraph> <paragraph num="(h)"> <text>Worcester; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Facilities in the Western region consisting of the following counties:</text> <paragraph num="(a)"> <text>Allegany;</text> </paragraph> <paragraph num="(b)"> <text>Garrett; and</text> </paragraph> <paragraph num="(c)"> <text>Washington.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>During the period July 1, 2019 through June 30, 2020, reimbursement for the Nursing Service cost center shall be the sum of 50 percent of the amount calculated in accordance with the reimbursement classes under §C of this regulation and 50 percent of the amount calculated in accordance with the reimbursement classes under §D of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Nursing Service Personnel and Procedures."> <paragraph num="A."> <text>Personnel Types and Category Groupings.</text> </paragraph> <paragraph num="B."> <text>Minimum Data Set Resource Utilization Groups Hourly Weights.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> <paragraph num="C."> <text>If the recipient is eligible for benefits from another payment source and elects to forfeit those benefits, the Program may reduce payment by the value of the benefits forfeited.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed;</text> </paragraph> <paragraph num="(5)"> <text>Denial of payment for new Medicaid admissions.</text> </paragraph> </paragraph> <paragraph num="A-1."> <text>Federal Remedies. If the Department determines that a provider is not in substantial compliance with federal requirements for participation in the Program, the Department may impose any of the remedies available under 42 CFR Part 488, Subpart F—Enforcement of Compliance for Long-Term Care Facilities with Deficiencies. The Department shall use the criteria set forth in 42 CFR Part 488, Subpart F, as the basis for imposing these remedies.</text> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department will give reasonable written notice to the nursing facility, to recipients, recipient's next of kin, and others who may be affected, of its intention to impose sanctions. The written notice will state the effective date and specific reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="D."> <text>A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Appeal Procedures."> <paragraph num="A."> <text>Except as provided for in §B of this regulation, providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </paragraph> <paragraph num="B."> <text>Nursing Home Appeal Board.</text> <paragraph num="(1)"> <text>Appeals regarding rate calculations or cost report adjustments which cannot be resolved administratively go to the Nursing Home Appeal Board.</text> </paragraph> <paragraph num="(2)"> <text>The Appeal Board shall be composed of the following members:</text> <paragraph num="(a)"> <text>A representative of the nursing home industry who is:</text> <paragraph num="(i)"> <text>Knowledgeable in Medicare and Medicaid reimbursement principles; and</text> </paragraph> <paragraph num="(ii)"> <text>Appointed by the Secretary;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual who:</text> <paragraph num="(i)"> <text>Is employed by the State;</text> </paragraph> <paragraph num="(ii)"> <text>Knowledgeable in Medicare and Medicaid reimbursement principles;</text> </paragraph> <paragraph num="(iii)"> <text>Did not directly participate in the field verification or desk review; and</text> </paragraph> <paragraph num="(iv)"> <text>Is appointed by the Secretary; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A third member selected by the first two members of the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the Board is reviewing an appeal from a provider in which a Board member is employed or in which he has a financial or personal interest, the Secretary shall designate an alternate for that member.</text> </paragraph> <paragraph num="(4)"> <text>If the provider elects to appeal to the Appeal Board and the Appeal Board finds in favor of the provider, the Department shall initiate a claims adjustment settlement for the impacted service dates within 60 days after the notification of the findings.</text> </paragraph> <paragraph num="(5)"> <text>The Department or any provider aggrieved by a reimbursement decision of the Appeal Board may not appeal to the Board of Review but may take a direct judicial appeal. The appeal shall be made as provided for judicial review of final decisions in the Administrative Procedure Act, §10-222, State Government Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>An appeal shall be filed in accordance with COMAR 10.01.09.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, 19-14B-01, and 19-310.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 9, 1975 (2:15 Md. R. 1070)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective January 30, 1976 (3:4 Md. R. 216)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective December 31, 1975 (3:4 Md. R. 216)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03Q adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03X amended effective September 29, 1976 (3:20 Md. R. 1143)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 17, 1977 (4:17 Md. R. 1298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 17, 1977 (4:17 Md. R. 1298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective January 30, 1976 (3:4 Md. R. 216)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 17, 1977 (4:17 Md. R. 1298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective August 17, 1977 (4:17 Md. R. 1298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective September 29, 1976 (3:20 Md. R. 1143)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, D amended effective January 30, 1976 (3:4 Md. R. 216)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); amended permanently effective October 21, 1977 (4:22 Md. R. 1671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective June 13, 1978 (5:13 Md. R. 1039)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .09 amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 15)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03, .06, .08, and .09 amended as an emergency provision effective March 15, 1978 (5:9 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 1978 (5:13 Md. R. 1051)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01U, HH, II, LL; .02; .03; .04G; .07; .09; .11E amended effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01M-1 and M-2 adopted effective July 1, 1980 (7:13 Md. R. 1278)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01O, .03D, and .11E amended effective January 1, 1980 (6:26 Md. R. 2074)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01JJ, KK; .07-1; .08A-1 adopted effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01P repealed effective January 1, 1980 (6:26 Md. R. 2074)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A repealed effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1132); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-2 adopted effective July 1, 1980 (7:13 Md. R. 1278)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 20, 1982 (9:25 Md. R. 2482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 1, 1983 (9:25 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective February 18, 1983 (10:6 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P amended, Q adopted effective June 6, 1983 (10:11 Md. R. 975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03R adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03S adopted effective July 28, 1986 (13:15 Md. R. 1734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03T and U adopted effective August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective October 29, 1984 (11:21 Md. R. 1812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 1, 1988 (15:11 Md. R. 1331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended and .07H adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B and E amended effective July 1, 1984 (11:12 Md. R. 1063)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C, F, G amended and .07C-1 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective October 29, 1984 (11:21 Md. R. 1812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective July 18, 1983 (10:14 Md. R. 1262); July 1, 1987 (14:13 Md. R. 1473); June 1, 1988 (15:11 Md. R. 1331); July 1, 1988 (15:13 Md. R. 1553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective January 26, 1988 (15:4 Md. R. 469); adopted permanently effective May 15, 1988 (15:8 Md. R. 1009)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective January 27, 1986 (13:2 Md. R. 137); July 1, 1988 (15:13 Md. R. 1533); September 5, 1988 (15:18 Md. R. 2147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective December 29, 1986 (13:26 Md. R. 2807)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H repealed effective August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1427); emergency status expired November 4, 1985</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 4, 1985 (12:22 Md. R. 2103)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective September 5, 1988 (15:18 Md. R. 2147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10I amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D repealed effective August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13E amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 21); adopted permanently effective May 1, 1983 (10:7 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14K adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14K repealed effective August 10, 1987 (14:16 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 27, 1989 (16:23 Md. R. 2505)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .07—.12, .16, and .25 amended as an emergency provision effective January 14, 1992 (19:3 Md. R. 299); emergency status expired June 30, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .07—.13, .16, .17, .23, and .25 amended as an emergency provision effective July 1, 1992 (19:14 Md. R. 1272); amended permanently effective November 1, 1992 (19:21 Md. R. 1891)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .04, .08—.11, .16, .17, .20, .21, and .23 amended as an emergency provision effective July 1, 2005 (32:19 Md. R. 1584); emergency status expired August 31, 2005</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03V amended effective October 3, 2011 (38:20 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03W adopted effective October 3, 2011 (38:20 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04, .10L, .11F, O, and .25B amended as an emergency provision effective July 3, 1990 (17:16 Md. R. 1986); amended permanently effective November 1, 1990 (17:21 Md. R. 2529)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04, .05, .07—.11, .13, .16, and .25 amended and new Regulation .09-1 adopted as an emergency provision effective October 1, 1999 (26:23 Md. R. 1775); adopted permanently effective January 9, 2000 (26:27 Md. R. 2015)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 15, 1994 (21:16 Md. R. 1383); December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D repealed effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04BB adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .04BB adopted effective September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07—.11 amended as an emergency provision effective December 1, 2001 (29:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07—.11-1 and .26 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1114); emergency status expired November 1, 1995; amended permanently effective November 6, 1995 (22:22 Md. R. 1658)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 8, 2002 (29:13 Md. R. 990)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016); December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective June 25, 1990 (17:12 Md. R. 1494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-2 adopted effective February 12, 2007 (34:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-2 amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-2, C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-2, C amended effective September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-3 adopted effective September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-3 amended effective April 6, 2009 (36:7 Md. R. 523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-4 adopted effective April 6, 2009 (36:7 Md. R. 523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective February 12, 2007 (34:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-1 amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-2 and C-3 adopted effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-4 adopted effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1 adopted as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); adopted permanently effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1F, I amended effective April 10, 2006 (33:7 Md. R. 668); August 27, 2007 (34:17 Md. R. 1508); September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1I amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1I amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); February 18, 2013 (40:3 Md. R. 218); February 3, 2014 (41:2 Md. R. 91); December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08—.11-1, .17, .20, and .21 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective November 4, 1996 (23:22 Md. R. 1496)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08—.11 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1149) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08—.11 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08—.11, .13, and .16 amended as an emergency provision effective July 1, 1999 (26:16 Md. R. 1237 and 26:18 Md. R. 1369); emergency status expired September 30, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 16, 2004 (31:3 Md. R. 207); September 22, 2008 (35:19 Md. R. 1716); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); December 12, 2013 (40:24 Md. R. 2016)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, E, H amended effective September 22, 2008 (35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08E, .09E, and .10L amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744; emergency status expired June 5, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulations .08E, .09E, and .10L amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1379); emergency status expired November 7, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H adopted effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E, F amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E, H amended effective September 22, 2008 35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09H adopted effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286</annotation> <annotation type="History" subtype="Administrative History">Regulation .09H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective September 20, 2010 (37:19 Md. R. 1283)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended effective December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10I amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10L amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10N adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .10N adopted effective September 22, 2008 35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 8, 2002 (29:13 Md. R. 990)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003; March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective July 1, 1993 (20:12 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744 and 21:16 Md. R. 1379; emergency status expired August 14, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective August 15, 1994 (21:16 Md. R. 1383); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); December 12, 2013 (40:24 Md. R. 2016)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G amended effective August 15, 1994 (21:16 Md. R. 1383); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904); April 5, 2010 (37:7 Md. R. 570); December 12, 2013 (40:24 Md. R. 2016)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11U adopted effective August 15, 1994 (21:16 Md. R. 1383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11U adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892; emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .11U adopted effective September 22, 2008 35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 adopted as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 530)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 repealed as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 repealed effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11-1—.11-6 adopted effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1A amended effective November 28, 2011 (38:24 Md. R. 1502)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-2E amended effective November 28, 2011 (38:24 Md. R. 1502)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective February 12, 2007 (34:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13E amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13L adopted effective August 15, 1994 (21:16 Md. R. 1383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13P adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .13P adopted effective September 22, 2008 35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C-1 adopted as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); adopted permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14G amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective March 19, 1990 (17:5 Md. R. 638); October 3, 2011 (38:20 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective March 17, 2003 (30:5 Md. R. 366)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective February 19, 1990 (17:3 Md. R. 297); December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16D amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulations .16E and G, and .17J amended and .17K adopted as an emergency provision effective April 4, 1991 (18:9 Md. R. 1004); adopted permanently effective July 22, 1991 (18:14 Md. R. 1609)</annotation> <annotation type="History" subtype="Administrative History">Regulations .16E and G amended and .30 adopted as an emergency provision effective January 1, 1991 (18:2 Md. R. 146); emergency status expired April 8, 1991 (18:9 Md. R. 1005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E amended effective September 27, 2004 (31:19 Md. R. 1432); October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16F amended effective March 17, 2003 (30:5 Md. R. 366)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16F amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .16F amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16G amended effective June 3, 1996 (23:11 Md. R. 810)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective July 8, 2002 (29:13 Md. R. 990); May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411); December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17K amended and L—O adopted effective June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulations .20—.23 amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective September 22, 2008 35:19 Md. R. 1716)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective December 9, 2005 (32:24 Md. R. 1904)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, B amended effective February 16, 2004 (31:3 Md. R. 207); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended effective August 15, 1994 (21:16 Md. R. 1383); February 16, 2004 (31:3 Md. R. 207); February 12, 2007 (34:3 Md. R. 297); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A-1 adopted as an emergency provision effective October 16, 1995 (22:22 Md. R. 1654); adopted permanently effective January 15, 1996 (23:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C amended effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 adopted effective May 9, 2005 (32:9 Md. R. 848)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 13, 2015 (42:7 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1I amended effective December 19, 2016 (43:25 Md. R. 1384); January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-2 amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-2L, M adopted effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-2N adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1B amended effective February 29, 2016 (43:4 Md. R. 331); December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-2B amended effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-7C amended effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-8C amended effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12-1A, B amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13O amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15-1 amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15-1D amended effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16-1G amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16-1I adopted effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25C adopted effective December 19, 2016 (43:25 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28B amended effective February 29, 2016 (43:4 Md. R. 331)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 2, 2018 (45:13 Md. R. 664)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 14, 2021 (48:12 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); November 14, 2022 (49:23 Md. R. 995); September 16, 2024 (51:18 Md. R. 808), March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H, I adopted effective November 14, 2022 (49:23 Md. R. 995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); June 14, 2021 (48:12 Md. R. 472); November 14, 2022 (49:23 Md. R. 995); August 7, 2023 (50:15 Md. R. 681); September 16, 2024 (51:18 Md. R. 808); March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective June 14, 2021 (48:12 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective June 14, 2021 (48:12 Md. R. 472</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective November 14, 2022 (49:23 Md. R. 995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21P adopted effective November 14, 2022 (49:23 Md. R. 995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22B amended effective November 14, 2022 (49:23 Md. R. 995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 amended effective December 30, 2019 (46:26 Md. R. 1164)</annotation> </annotations> </chapter> <chapter num="11" heading="Maryland Children's Health Program"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter governs the determination of eligibility for the Maryland Children's Health Program with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014.</text> </paragraph> <paragraph num="B."> <text>Eligibility for the Maryland Children's Health Program may be established for children younger than 19 years old whose family income is equal to or less than 200 percent of the federal poverty level.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56).</text> </paragraph> <paragraph num="(2)"> <text>Applicant.</text> <paragraph num="(a)"> <text>“Applicant” means an individual whose written application for the Maryland Children's Health Program has been submitted to the local health department or the local department of social services but has not received final action.</text> </paragraph> <paragraph num="(b)"> <text>“Applicant” includes an individual whose application is submitted through a representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>“Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized Representative” has the meaning stated in COMAR 10.01.04.12.</text> </paragraph> <paragraph num="(6)"> <text>“Child” means an individual younger than 21 years old.</text> </paragraph> <paragraph num="(7)"> <text>“Child recipient” means a child younger than 19 years old who is certified as eligible for the Program.</text> </paragraph> <paragraph num="(8)"> <text>“Children’s Health Insurance Program” means the program for uninsured targeted low-income children established under Title XXI of the Social Security Act.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Designee” means any entity designated to act on behalf of the Department such as:</text> <paragraph num="(a)"> <text>Baltimore City or a county social services department under the supervision of the Department of Human Services;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore City Health Department and its subgrantees, or a county health department; and</text> </paragraph> <paragraph num="(c)"> <text>The Maryland Health Benefit Exchange.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Determination” means a decision regarding an applicant's eligibility for the Maryland Children's Health Program.</text> </paragraph> <paragraph num="(12)"> <text>“Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and recipients.</text> </paragraph> <paragraph num="(13)"> <text>Emergency Medical Condition.</text> <paragraph num="(a)"> <text>“Emergency medical condition” means a condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part.</text> </paragraph> <paragraph num="(b)"> <text>“Emergency medical condition” includes labor and delivery.</text> </paragraph> <paragraph num="(c)"> <text>“Emergency medical condition” does not include services related to an organ transplant procedure.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Family members” means those individuals living with the applicant whose income is counted, or would be counted if there were any, as household income under Regulation .07B of this chapter.</text> </paragraph> <paragraph num="(15)"> <text>“Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981.</text> </paragraph> <paragraph num="(16)"> <text>“Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided.</text> </paragraph> <paragraph num="(17)"> <text>“Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04.</text> </paragraph> <paragraph num="(18)"> <text>“Insurance Affordability Program” means a program that is one of the following:</text> <paragraph num="(a)"> <text>The Maryland State Medicaid program;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium;</text> </paragraph> <paragraph num="(c)"> <text>An optional state basic health program established under §1331 of the Affordable Care Act;</text> </paragraph> <paragraph num="(d)"> <text>A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or</text> </paragraph> <paragraph num="(e)"> <text>A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Living together” means sharing a common household.</text> </paragraph> <paragraph num="(20)"> <text>“Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department.</text> </paragraph> <paragraph num="(21)"> <text>“MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act.</text> </paragraph> <paragraph num="(22)"> <text>“MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI.</text> </paragraph> <paragraph num="(23)"> <text>“Maryland Children's Health Program (Program)” means the program established in Health-General Article, §15-301 et seq., Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children.</text> </paragraph> <paragraph num="(24)"> <text>“Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program.</text> </paragraph> <paragraph num="(25)"> <text>“Maryland Medicaid Managed Care Program” means the Health Choice Program authorized by:</text> <paragraph num="(a)"> <text>Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>A waiver issued by the federal government under §1115 of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Medical Assistance (Medicaid)” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible individuals.</text> </paragraph> <paragraph num="(27)"> <text>“Period under consideration” means the specific months which are assessed in order to determine eligibility.</text> </paragraph> <paragraph num="(28)"> <text>Public Institution.</text> <paragraph num="(a)"> <text>“Public institution” includes an:</text> <paragraph num="(i)"> <text>Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or</text> </paragraph> <paragraph num="(ii)"> <text>An establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves not more than 16 residents.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Qualified alien” means an individual who:</text> <paragraph num="(a)"> <text>Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA);</text> </paragraph> <paragraph num="(b)"> <text>Has been granted asylum in the United States as a refugee under §208 of the INA;</text> </paragraph> <paragraph num="(c)"> <text>Has been admitted into the United States as a refugee under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year;</text> </paragraph> <paragraph num="(e)"> <text>Has had deportation withheld under §243(h) of the INA;</text> </paragraph> <paragraph num="(f)"> <text>Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980;</text> </paragraph> <paragraph num="(g)"> <text>Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if:</text> <paragraph num="(i)"> <text>The spouse or parent consented to, or acquiesced in, the battery or cruelty;</text> </paragraph> <paragraph num="(ii)"> <text>The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with Immigration and Naturalization Service (INS); and</text> </paragraph> <paragraph num="(iii)"> <text>In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Is a victim of a severe form of trafficking who has been subjected to:</text> <paragraph num="(i)"> <text>Sex trafficking if the act is induced by force, fraud, or coercion, or the individual induced to perform the act is younger than 18 years old; or</text> </paragraph> <paragraph num="(ii)"> <text>Involuntary servitude;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or</text> </paragraph> <paragraph num="(j)"> <text>Is an American Indian born in Canada to whom §289 of the INA applies.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Recipient” means an individual who is certified as eligible for the Maryland Children's Health Program.</text> </paragraph> <paragraph num="(31)"> <text>“Redetermination” means a determination regarding the continuing eligibility of a recipient.</text> </paragraph> <paragraph num="(32)"> <text>“Spouse” means an individual who has been determined to be the husband or wife of another person under State law and for the purpose of determining eligibility for Social Security benefits.</text> </paragraph> <paragraph num="(33)"> <text>“Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low income individuals.</text> </paragraph> <paragraph num="(34)"> <text>“Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the Maryland Children's Health Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Coverage Groups."> <text>Eligibility may be established for the Maryland Children's Health Program for children younger than 19 years old whose household income is equal to or less than 200 percent of the federal poverty level.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Application."> <paragraph num="A."> <text>The Department or its designee shall determine eligibility for children.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall give oral, written, or electronic information about the Maryland Children’s Health Program such as:</text> <paragraph num="(1)"> <text>Requirements for eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Available services;</text> </paragraph> <paragraph num="(3)"> <text>An individual's rights and responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>Information in plain English, supported by translation services; and</text> </paragraph> <paragraph num="(5)"> <text>Information accessible to disabled individuals requesting an application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply.</text> </paragraph> <paragraph num="D."> <text>The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application.</text> </paragraph> <paragraph num="E."> <text>A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall:</text> <paragraph num="(1)"> <text>Demonstrate continued residency in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all nonfinancial and financial requirements in order to be determined eligible.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Application Filing and Signature Requirements.</text> <paragraph num="(1)"> <text>An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice.</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The date of application shall be the date on which a written, telephonic, or electronic, signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee.</text> </paragraph> <paragraph num="H."> <text>An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation.</text> </paragraph> <paragraph num="I."> <text>Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation. For a child, the period under consideration is the 12-month period beginning with the month of application.</text> </paragraph> <paragraph num="J."> <text>Processing Applications — Time Limitations.</text> <paragraph num="(1)"> <text>When a written, telephonic or electronic application is filed, a decision shall be made promptly but not later than:</text> <paragraph num="(a)"> <text>10 days from the date of application when filed at the local health department; or</text> </paragraph> <paragraph num="(b)"> <text>30 days from the date of application when filed at the Department or its designee, but not the local health department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The time standards specified in §J(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant.</text> </paragraph> <paragraph num="(3)"> <text>The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit of 10 or 30 days.</text> </paragraph> <paragraph num="(4)"> <text>When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 10 or 30 day limit provided under §J(1)of this regulation, the applicant shall be determined ineligible.</text> </paragraph> <paragraph num="(5)"> <text>If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Required Information. All information needed to determine eligibility for the Maryland Children's Health Program shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application: Additional Requirements."> <paragraph num="A."> <text>Social Security Number.</text> <paragraph num="(1)"> <text>As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection.</text> </paragraph> <paragraph num="(2)"> <text>Eligibility may not be established until the applicant:</text> <paragraph num="(a)"> <text>Furnishes a Social Security number; or</text> </paragraph> <paragraph num="(b)"> <text>Requests the assignment of the number through the Social Security Administration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failure to provide the required Social Security number shall result in ineligibility for the applicant.</text> </paragraph> <paragraph num="(4)"> <text>If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds.</text> </paragraph> <paragraph num="(5)"> <text>If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration.</text> </paragraph> <paragraph num="(6)"> <text>Individuals described under COMAR 10.09.24.05D(4)(b) who are applying for limited benefits to treat an emergency medical condition are not subject to the requirements in §A(1)—(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Third-Party Liability.</text> <paragraph num="(1)"> <text>A recipient shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the recipient's medical expenses.</text> </paragraph> <paragraph num="(2)"> <text>A recipient shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments.</text> </paragraph> <paragraph num="(3)"> <text>In accident situations, a recipient shall notify the Department or its designee of the:</text> <paragraph num="(a)"> <text>Time, date, and location of the accident;</text> </paragraph> <paragraph num="(b)"> <text>Name and address of the attorney;</text> </paragraph> <paragraph num="(c)"> <text>Names and addresses of all parties and witnesses to the accident; and</text> </paragraph> <paragraph num="(d)"> <text>Police report number if an investigation is made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Department or its designee shall:</text> <paragraph num="(1)"> <text>Maintain a written or electronic record including documentation of any required elements of eligibility; and</text> </paragraph> <paragraph num="(2)"> <text>Restrict disclosure of information concerning a recipient to purposes directly connected with the administration of the Medical Assistance Program, including:</text> <paragraph num="(a)"> <text>Establishing eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Determining the extent of coverage under Medical Assistance;</text> </paragraph> <paragraph num="(c)"> <text>Providing services for recipients; and</text> </paragraph> <paragraph num="(d)"> <text>Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nonfinancial Eligibility Requirements."> <paragraph num="A."> <text>Citizenship. In order to be eligible for full benefits under the Maryland Children's Health Program, an individual shall meet the federal requirements for Medical Assistance eligibility as a citizen or qualified alien, as specified at COMAR 10.09.24.05.</text> </paragraph> <paragraph num="B."> <text>Residency. In order to be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements at COMAR 10.09.24.05-3.</text> </paragraph> <paragraph num="C."> <text>Age. In order to be eligible for benefits under this chapter, a child shall be younger than 19 years old.</text> </paragraph> <paragraph num="D."> <text>Inmate of a Public Institution. In order to receive benefits under this chapter, an individual may not be an inmate of a public institution, as specified at COMAR 10.09.24.05-5B.</text> </paragraph> <paragraph num="E."> <text>Institution for Mental Diseases. In order to be eligible for benefits under this chapter, an individual between 21 and 64 years old or a child applying under Title XXI of the Social Security Act may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C.</text> </paragraph> <paragraph num="F."> <text>No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, an individual whose income is equal to 133 percent but less than 200 percent of the Federal Poverty Level, may not be covered by an employer-sponsored health benefit plan.</text> </paragraph> <paragraph num="G."> <text>An alien who fails to meet the requirements under §A of this regulation, but meets all other nonfinancial and financial factors of eligibility under this chapter, may be determined eligible for coverage under COMAR 10.09.24.05-2.</text> </paragraph> <paragraph num="H."> <text>Documentation of Citizenship and Identity.</text> <paragraph num="(1)"> <text>An applicant may not be determined eligible for Maryland Children’s Health Program until the requirements of this regulation are met.</text> </paragraph> <paragraph num="(2)"> <text>An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is:</text> <paragraph num="(a)"> <text>Declared to be a citizen or national of the United States; and</text> </paragraph> <paragraph num="(b)"> <text>Being determined for:</text> <paragraph num="(i)"> <text>Initial eligibility based on an application filed on or after September 1, 2006; or</text> </paragraph> <paragraph num="(ii)"> <text>Continuing eligibility based on a redetermination with an end date on or after September 30, 2006.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant may be determined eligible for Maryland Children’s Health Program for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible.</text> </paragraph> <paragraph num="(4)"> <text>If an applicant or recipient fails to meet the requirements of §H of this regulation within the time standards specified in Regulation .04J(1) of this chapter, and the time standards are not extended, the Department shall:</text> <paragraph num="(a)"> <text>Deny eligibility for an applicant; or</text> </paragraph> <paragraph num="(b)"> <text>Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The requirements at §H of this regulation shall be met for all Medical Assistance coverage groups except for:</text> <paragraph num="(a)"> <text>Supplemental Security Income beneficiaries;</text> </paragraph> <paragraph num="(b)"> <text>Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth;</text> </paragraph> <paragraph num="(c)"> <text>Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of under COMAR 10.09.24.05-2 who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth;</text> </paragraph> <paragraph num="(d)"> <text>Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare;</text> </paragraph> <paragraph num="(e)"> <text>Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Social Security Act, based on the individual's disability;</text> </paragraph> <paragraph num="(f)"> <text>Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and</text> </paragraph> <paragraph num="(g)"> <text>Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Continuing eligibility for a recipient may not be approved at redetermination until the requirements of §H of this regulation are met.</text> </paragraph> <paragraph num="(7)"> <text>If there is documentation in an applicant's or recipient's written or electronic record or a federal or state's database that demonstrates that the individual meets the requirements of §H of this regulation, the individual shall be considered to meet the requirements of §H of this regulation, unless the:</text> <paragraph num="(a)"> <text>Department has cause to question the documentation previously accepted; or</text> </paragraph> <paragraph num="(b)"> <text>Federal government requires additional documentation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Consideration of Household Income."> <paragraph num="A."> <text>The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent.</text> </paragraph> <paragraph num="B."> <text>Determining Countable Household Income.</text> <paragraph num="(1)"> <text>In determining an applicant's financial eligibility for the Maryland Children's Health Program, the applicant's current household income is considered.</text> </paragraph> <paragraph num="(2)"> <text>For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the child applicant and the following family members when living with the child applicant:</text> <paragraph num="(a)"> <text>The child applicant's parents; and</text> </paragraph> <paragraph num="(b)"> <text>At the option of the child applicant's parents, any of the child applicant's siblings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For the married child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the married child applicant and the married child applicant's spouse.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application.</text> </paragraph> <paragraph num="D."> <text>Treatment of Income.</text> <paragraph num="(1)"> <text>Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI.</text> </paragraph> <paragraph num="(2)"> <text>MAGI income limits shall be:</text> <paragraph num="(a)"> <text>Converted from traditional income limits to account for elimination of income disregards.</text> </paragraph> <paragraph num="(b)"> <text>Increased by 5 percentage points of the federal poverty level for the following circumstances:</text> <paragraph num="(i)"> <text>When an individual’s income exceeds the Medicaid income standard; and</text> </paragraph> <paragraph num="(ii)"> <text>The income standard is the highest income standard under which the individual can be determined eligible.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Household Composition. For purposes of determining the income standard applicable to an applicant or recipient, the following rules apply.</text> <paragraph num="(a)"> <text>An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made.</text> </paragraph> <paragraph num="(b)"> <text>For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals:</text> <paragraph num="(i)"> <text>Spouse; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted or step children.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals:</text> <paragraph num="(i)"> <text>Natural, adopted, or step parents; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted, or step siblings.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>No resources or assets test may be applied to an applicant or recipient who is subject to a MAGI-based income test.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Consideration of Family Income: Earned and Unearned Income — Repealed." /> <regulation prefix="Regulation" num=".09" heading="Consideration of Family Income: Income Disregards — Repealed." /> <regulation prefix="Regulation" num=".10" heading="Determining Financial Eligibility."> <text>An applicant is financially eligible for the Maryland Children's Health Program if, for the period under consideration, the applicant's countable household income as determined under Regulation .07 of this chapter does not exceed 200 percent of the federal poverty level for a family size equal to the size of the family for child applicants younger than 19 years old.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Certification Periods."> <paragraph num="A."> <text>For a newborn, certification begins on the day the child is born to an eligible woman and ends on the last day of the month of the child's 1st birthday.</text> </paragraph> <paragraph num="B."> <text>For an eligible child, certification begins on the first day of the month of application, or up to 3 months before the month of application, if medical expenses were incurred during the earlier months, and continues until the day the child is determined ineligible.</text> </paragraph> <paragraph num="C."> <text>A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under this chapter and who, but for attaining that age, would remain eligible for Medical Assistance benefits, shall continue to receive benefits until the end of the stay for which acute inpatient services are furnished.</text> </paragraph> <paragraph num="D."> <text>Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Covered Services."> <paragraph num="A."> <text>A child certified for the Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program.</text> </paragraph> <paragraph num="B."> <text>In the case of an alien who is eligible for benefits under COMAR 10.09.24.05D(4)(b), covered services are limited to those that are necessary for the treatment of an emergency medical condition, as defined under Regulation .02B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Post-Eligibility Requirements."> <paragraph num="A."> <text>Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following:</text> <paragraph num="(1)"> <text>For eligible individuals:</text> <paragraph num="(a)"> <text>The basis and effective date for eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Instructions for reporting changes that may affect the recipients eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For ineligible individuals:</text> <paragraph num="(a)"> <text>A finding of ineligibility, the reason for the finding, and the regulation supporting the finding;</text> </paragraph> <paragraph num="(b)"> <text>Information regarding application for MAGI Exempt coverage groups; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Recipient Responsibility. After an individual has been determined to be eligible for MCHP and is enrolled in MCHP:</text> <paragraph num="(1)"> <text>The Department shall periodically redetermine the recipient's eligibility for MCHP as specified under §D; and</text> </paragraph> <paragraph num="(2)"> <text>The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's:</text> <paragraph num="(a)"> <text>Income;</text> </paragraph> <paragraph num="(b)"> <text>Employment;</text> </paragraph> <paragraph num="(c)"> <text>Address; or</text> </paragraph> <paragraph num="(d)"> <text>Health insurance coverage status.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A recipient or the recipient's representative shall limit use of the Medical Assistance card to the individual whose name appears on the card.</text> </paragraph> <paragraph num="(4)"> <text>When written or electronic notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department.</text> </paragraph> <paragraph num="(5)"> <text>Failure to comply with the provisions of §B(1)—(3) of this regulation may result in:</text> <paragraph num="(a)"> <text>The termination of assistance; or</text> </paragraph> <paragraph num="(b)"> <text>Referral to the Department for fraud investigation, or for criminal or civil prosecution.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A recipient shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility.</text> </paragraph> <paragraph num="(7)"> <text>If the recipient refuses to cooperate, the recipient's coverage shall be terminated subject to the regulation governing timely and adequate notice under COMAR 10.01.04.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unscheduled Redetermination.</text> <paragraph num="(1)"> <text>The Department or its designee shall:</text> <paragraph num="(a)"> <text>Promptly make an unscheduled redetermination of a child recipient's eligibility when changes in circumstances or relevant facts are:</text> <paragraph num="(i)"> <text>Reported by someone on the recipient's behalf, or</text> </paragraph> <paragraph num="(ii)"> <text>Brought to the attention of the Department or its designee from other responsible sources;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Notify the recipient that redetermination is required to establish continuing eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Eligibility Decisions. Recipients who are determined:</text> <paragraph num="(a)"> <text>Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A recipient whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Scheduled Redetermination. Except for children eligible as newborns of eligible women, the Department or its designee shall make a scheduled redetermination of a child recipient's eligibility at least every 12 months.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Hearings."> <text>The requirements relating to hearings under COMAR 10.01.04 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Fraud and Abuse."> <text>The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Adjustments and Recoveries."> <text>The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, with the exception of COMAR 10.09.24.15A(1) and (2), apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-101(f), 15-103, 15-105, and 15-301 et seq., Annotated Code of Maryland, Ch. 202, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 adopted as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); adopted permanently effective November 30, 1998 (25:24 Md. R. 1773)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.07 and .09—.13 amended as an emergency provision effective July 1, 2001 (28:14 Md. R. 1319); amended permanently October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04I amended effective June 21, 2004 (31:12 Md. R. 911)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 8, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective June 21, 2004 (31:12 Md. R. 911)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I amended effective April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective June 21, 2004 (31:12 Md. R. 911); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .10A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D adopted effective April 13, 2026 (53:7 Md. R. 328)</annotation> </annotations> </chapter> <chapter num="12" heading="Disposable Medical Supplies and Durable Medical Equipment"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients.</text> </paragraph> <paragraph num="(2)"> <text>“Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product:</text> <paragraph num="(a)"> <text>For a specific recipient according to the description and orders of a physician; and</text> </paragraph> <paragraph num="(b)"> <text>In such a way that the equipment can only be used by the specific recipient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means Maryland Department of Health as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(4)"> <text>“Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition.</text> </paragraph> <paragraph num="(5)"> <text>“Durable medical equipment” means equipment which satisfies all of the following requirements:</text> <paragraph num="(a)"> <text>It can withstand repeated use;</text> </paragraph> <paragraph num="(b)"> <text>It is used to serve a medically necessary purpose; and</text> </paragraph> <paragraph num="(c)"> <text>It has no practical use in the absence of illness, injury, disability, or health condition.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution.</text> </paragraph> <paragraph num="(7)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(8)"> <text>“Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult.</text> </paragraph> <paragraph num="(9)"> <text>“Invoice” means a form designated by the Department for use by providers in submitting bills for payment.</text> </paragraph> <paragraph num="(10)"> <text>“Maximum allowable reimbursement” means the payment limitation established by the Department.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Medicare” means Medicare as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(14)"> <text>“Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02.</text> </paragraph> <paragraph num="(15)"> <text>“Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body.</text> </paragraph> <paragraph num="(16)"> <text>“Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient.</text> </paragraph> <paragraph num="(17)"> <text>“Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed.</text> </paragraph> <paragraph num="(18)"> <text>“Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient.</text> </paragraph> <paragraph num="(19)"> <text>“Prescriber order” means a document on the prescriber's letterhead or prescription form which details the:</text> <paragraph num="(a)"> <text>Patient name and Medical Assistance number;</text> </paragraph> <paragraph num="(b)"> <text>Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber;</text> </paragraph> <paragraph num="(c)"> <text>Estimated quantity of the item;</text> </paragraph> <paragraph num="(d)"> <text>Length of time of need;</text> </paragraph> <paragraph num="(e)"> <text>Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and</text> </paragraph> <paragraph num="(f)"> <text>Prescriber’s signature.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Prescription” means a written order for medical supplies or equipment, signed by the prescriber.</text> </paragraph> <paragraph num="(21)"> <text>“Program” means program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(22)"> <text>“Prosthetic device” means:</text> <paragraph num="(1)"> <text>An artificial device to replace, in whole or in part, a leg, arm, or eye; or</text> </paragraph> <paragraph num="(2)"> <text>An artificial breast, including surgical brassiere.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Provider” means provider as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(24)"> <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(25)"> <text>Wholesale cost.</text> <paragraph num="(a)"> <text>“Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid.</text> </paragraph> <paragraph num="(b)"> <text>“Wholesale cost” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Shipping;</text> </paragraph> <paragraph num="(ii)"> <text>Handling; and</text> </paragraph> <paragraph num="(iii)"> <text>Insurance costs.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Wholesale cost” does not include associated costs such as:</text> <paragraph num="(i)"> <text>Evaluation;</text> </paragraph> <paragraph num="(ii)"> <text>Assembly by the provider;</text> </paragraph> <paragraph num="(iii)"> <text>Fitting and adjustment; and</text> </paragraph> <paragraph num="(iv)"> <text>Delivery to the recipient.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>Providers of services shall meet the licensing requirements as set forth in COMAR 10.09.36.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider:</text> <paragraph num="A."> <text>Effective January 1, 2018, shall be in an approved status with Medicare;</text> </paragraph> <paragraph num="B."> <text>Effective April 1, 2012 through December 31, 2017, shall, unless exempt from Medicare accreditation requirements:</text> <paragraph num="(1)"> <text>Be accredited by a Medicare-approved accreditation organization;</text> </paragraph> <paragraph num="(2)"> <text>Provide documentation of:</text> <paragraph num="(a)"> <text>Accreditation; or</text> </paragraph> <paragraph num="(b)"> <text>Having submitted an application for accreditation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be accredited or terminated from the Program;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall meet the conditions for participation as set forth in COMAR 10.09.36.03;</text> </paragraph> <paragraph num="D."> <text>Shall be prepared to furnish necessary service and repairs to equipment dispensed by the provider;</text> </paragraph> <paragraph num="E."> <text>Shall certify residential service agency status as set forth in COMAR 10.07.05 by submitting either a:</text> <paragraph num="(1)"> <text>Copy of the license; or</text> </paragraph> <paragraph num="(2)"> <text>Form supplied by the Department which documents exempt status;</text> </paragraph> </paragraph> <paragraph num="F."> <text>May not charge the recipient any fee or deposit;</text> </paragraph> <paragraph num="G."> <text>Shall collect and report as a collection any and all possible rebates or other third-party reimbursement;</text> </paragraph> <paragraph num="H."> <text>Shall mark durable medical equipment with an identification tag as specified and provided by the Program, noting the tag number on all appropriate delivery tickets; and</text> </paragraph> <paragraph num="I."> <text>Shall participate in the Program's recycling efforts as set forth in Regulation .07O of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service:</text> <paragraph num="(1)"> <text>Disposable medical supplies;</text> </paragraph> <paragraph num="(2)"> <text>Durable medical equipment;</text> </paragraph> <paragraph num="(3)"> <text>Repairs to purchased durable medical equipment;</text> </paragraph> <paragraph num="(4)"> <text>All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;</text> </paragraph> <paragraph num="(5)"> <text>Orthotic devices;</text> </paragraph> <paragraph num="(6)"> <text>Repair of orthotic devices;</text> </paragraph> <paragraph num="(7)"> <text>Replacement of orthotic devices;</text> </paragraph> <paragraph num="(8)"> <text>Prosthetic devices which include:</text> <paragraph num="(a)"> <text>Artificial eyes;</text> </paragraph> <paragraph num="(b)"> <text>Breast prostheses, including surgical brassiere;</text> </paragraph> <paragraph num="(c)"> <text>Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and</text> </paragraph> <paragraph num="(d)"> <text>Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Repair of prosthetic devices;</text> </paragraph> <paragraph num="(10)"> <text>Replacement of prosthetic devices;</text> </paragraph> <paragraph num="(11)"> <text>Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older;</text> </paragraph> <paragraph num="(12)"> <text>Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter;</text> </paragraph> <paragraph num="(13)"> <text>Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and</text> </paragraph> <paragraph num="(14)"> <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The items in §A of this regulation are covered when medically necessary for use in the recipient's:</text> <paragraph num="(1)"> <text>Home;</text> </paragraph> <paragraph num="(2)"> <text>School; or</text> </paragraph> <paragraph num="(3)"> <text>Place of employment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health.</text> </paragraph> <paragraph num="D."> <text>Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community.</text> </paragraph> <paragraph num="E."> <text>Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions.</text> </paragraph> <paragraph num="F."> <text>Replacements under §A(10) are covered:</text> <paragraph num="(1)"> <text>Once annually for devices less than 3 years old if the replacement is for the following reasons:</text> <paragraph num="(a)"> <text>A change in the physiological condition of the patient;</text> </paragraph> <paragraph num="(b)"> <text>Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or</text> </paragraph> <paragraph num="(c)"> <text>Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For devices more than 3 years old subject to §§B and C of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Documentation Required.</text> <paragraph num="(1)"> <text>Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the:</text> <paragraph num="(a)"> <text>Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services;</text> </paragraph> <paragraph num="(b)"> <text>Recertifications of continuous medical need;</text> </paragraph> <paragraph num="(c)"> <text>Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket;</text> </paragraph> <paragraph num="(d)"> <text>Make, model, and serial number of the item, as applicable; and</text> </paragraph> <paragraph num="(e)"> <text>Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>Documentation shall be retained for 6 years and be made available upon request by the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover:</text> <paragraph num="A."> <text>Incontinency pants and disposable underpads unless the following conditions are met:</text> <paragraph num="(1)"> <text>The incontinence supplies are medically necessary for medical conditions associated with prolonged urinary or bowel incontinence;</text> </paragraph> <paragraph num="(2)"> <text>For pull-on underwear type garments, the recipient is capable of independently putting on and removing the garment; and</text> </paragraph> <paragraph num="(3)"> <text>Disposable incontinence supplies meet, at a minimum, the following absorbent capacity standards:</text> <paragraph num="(a)"> <text>For children's diapers and underwear, not less than 800cc;</text> </paragraph> <paragraph num="(b)"> <text>For youth diapers and underwear, not less than 1,000cc;</text> </paragraph> <paragraph num="(c)"> <text>For small adult diapers and underwear, not less than 1,200cc;</text> </paragraph> <paragraph num="(d)"> <text>For medium adult diapers and underwear, not less than 1,750cc;</text> </paragraph> <paragraph num="(e)"> <text>For large, extra large, and bariatric adult diapers and underwear, not less than 2,000cc; and</text> </paragraph> <paragraph num="(f)"> <text>For disposable underpads, not less than 1,000 cc;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Osteogenesis stimulators unless the following criteria are met:</text> <paragraph num="(1)"> <text>The use is for noninvasive therapy;</text> </paragraph> <paragraph num="(2)"> <text>The bone fracture is at least 6 months old, except when used for pseudarthrosis; and</text> </paragraph> <paragraph num="(3)"> <text>The space gap of the fracture measures 1/2 centimeter or less, except when used for pseudarthrosis;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Osteogenesis stimulators beyond the first 6 weeks of use unless evaluations at the 6-week and 3-month intervals after initial date of service verify recipient use of at least 50 percent of the time prescribed, on a form designated by the Program;</text> </paragraph> <paragraph num="D."> <text>The following durable medical equipment:</text> <paragraph num="(1)"> <text>Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, emesis basins, posture support chairs, over-the-bed tables;</text> </paragraph> <paragraph num="(2)"> <text>Self-help devices including, but not limited to, grab bars, shower stools, and commode seats;</text> </paragraph> <paragraph num="(3)"> <text>Abdominal supports;</text> </paragraph> <paragraph num="(4)"> <text>Bed boards;</text> </paragraph> <paragraph num="(5)"> <text>Enema bags;</text> </paragraph> <paragraph num="(6)"> <text>Environmental controls;</text> </paragraph> <paragraph num="(7)"> <text>Exercise equipment and devices, unless home use of such equipment is a necessary component of an active physical therapy program;</text> </paragraph> <paragraph num="(8)"> <text>Geriatric chairs;</text> </paragraph> <paragraph num="(9)"> <text>Heating pads or lamps;</text> </paragraph> <paragraph num="(10)"> <text>Hot water bottles;</text> </paragraph> <paragraph num="(11)"> <text>Hydrocollators;</text> </paragraph> <paragraph num="(12)"> <text>Ice bags;</text> </paragraph> <paragraph num="(13)"> <text>Knee cages;</text> </paragraph> <paragraph num="(14)"> <text>Nasal atomizers;</text> </paragraph> <paragraph num="(15)"> <text>Restraints;</text> </paragraph> <paragraph num="(16)"> <text>Sitz baths;</text> </paragraph> <paragraph num="(17)"> <text>Soft collars;</text> </paragraph> <paragraph num="(18)"> <text>Whirlpools;</text> </paragraph> <paragraph num="(19)"> <text>Whirlpool bath equipment;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disposable medical supplies and durable medical equipment provided in a facility or by a group when reimbursement is covered by another segment of the Program;</text> </paragraph> <paragraph num="F."> <text>Items which are investigational or experimental in nature;</text> </paragraph> <paragraph num="G."> <text>Nutritional supplements supplied by a DMS/DME provider under this chapter if the provider is also a licensed pharmacy and has a Medicaid Pharmacy provider number;</text> </paragraph> <paragraph num="H."> <text>Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products, when administered orally;</text> </paragraph> <paragraph num="I."> <text>Purchase of used equipment, except as approved by the Department as per Regulation .07L of this chapter;</text> </paragraph> <paragraph num="J."> <text>Equipment if the recipient owns or otherwise has access to useable equipment that serves the same purpose as the requested equipment;</text> </paragraph> <paragraph num="K."> <text>Replacement of equipment or a device while the item is still under warranty or before having met the Department’s life expectancy schedule unless prepayment authorization has been obtained.</text> </paragraph> <paragraph num="L."> <text>Replacement of a prosthetic device or component if necessary due to misuse.</text> </paragraph> <paragraph num="M."> <text>Rental of any equipment not in good working condition for the entire length of rental;</text> </paragraph> <paragraph num="N."> <text>Rental of equipment for any period longer than 90 days without renewed documentation of continued medical need from the prescriber for each 90-day period;</text> </paragraph> <paragraph num="O."> <text>Modifications to motor vehicles;</text> </paragraph> <paragraph num="P."> <text>Disposable medical supplies and durable medical equipment ordered by an individual who is not enrolled as a provider in the Program on the date of service; and</text> </paragraph> <paragraph num="Q."> <text>Disposable medical supplies and durable medical equipment ordered by an entity, facility, or other provider that is not an individual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prepayment Authorization Requirements."> <paragraph num="A."> <text>Prepayment authorization is required for:</text> <paragraph num="(1)"> <text>Disposable medical supplies with a charge exceeding $500, except as specified in §B(1) and (4) of this regulation and durable medical equipment on the approved list of items as individual consideration (I/C);</text> </paragraph> <paragraph num="(2)"> <text>All incontinency pants for recipients 3 through 15 years old in excess of 240 in any 30-day period, and disposable underpads for recipients 3 through 15 years old in excess of 135 in any 30-day period;</text> </paragraph> <paragraph num="(3)"> <text>All incontinency pants for recipients 16 years old or older in excess of 180 in any 30-day period, and disposable underpads for recipients 16 years old or older in excess of 100 in any 30-day period;</text> </paragraph> <paragraph num="(4)"> <text>All disposable incontinency pants and all disposable underpads for recipients younger than 3 years old;</text> </paragraph> <paragraph num="(5)"> <text>Disposable medical supplies and durable medical equipment not on the approved list of items;</text> </paragraph> <paragraph num="(6)"> <text>Any rental of durable medical equipment after 3 months of rental;</text> </paragraph> <paragraph num="(7)"> <text>All repairs to purchased durable medical equipment exceeding $500;</text> </paragraph> <paragraph num="(8)"> <text>Durable medical equipment with a purchase price of $1,000 or more except as specified in §B(1) and (4) of this regulation;</text> </paragraph> <paragraph num="(9)"> <text>Prosthetics and orthotics with a charge exceeding $1,000 except as specified in §B(1) and (4) of this regulation; and</text> </paragraph> <paragraph num="(10)"> <text>Medical equipment, supplies not listed on the approved list of items.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prepayment authorization is not required for:</text> <paragraph num="(1)"> <text>Any disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;</text> </paragraph> <paragraph num="(2)"> <text>Prosthetic devices under $1,000;</text> </paragraph> <paragraph num="(3)"> <text>Orthotic equipment under $1,000; and</text> </paragraph> <paragraph num="(4)"> <text>Enteral and parenteral supplies not exceeding one unit per day.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For the rental of durable medical equipment, the following prepayment authorization requirements apply:</text> <paragraph num="(1)"> <text>For durable medical equipment below $1,000:</text> <paragraph num="(a)"> <text>Months 1 through 3, the rental does not require a prepayment authorization;</text> </paragraph> <paragraph num="(b)"> <text>Months 4 through 10, the rental does require a prepayment authorization; and</text> </paragraph> <paragraph num="(c)"> <text>Month 10 is the final rental month, after which the item is considered purchased.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For durable medical equipment above $1,000, and items requiring individual consideration:</text> <paragraph num="(a)"> <text>Months 1 through 10, the rental does require prepayment authorization; and</text> </paragraph> <paragraph num="(b)"> <text>Month 10 is the final rental month, after which the item is considered purchased.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The prescriber shall submit requests for prepayment authorization, when required, using the format and procedures designated by the Department.</text> </paragraph> <paragraph num="E."> <text>Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile shall be followed by a request for prepayment authorization, which shall be submitted immediately to the Department. Providers shall call the Program before making a request via facsimile.</text> </paragraph> <paragraph num="F."> <text>Except as provided in §H of this regulation, providers shall submit prepayment authorization requests to the Program not later than 30 days following the first date of service.</text> </paragraph> <paragraph num="G."> <text>Prepayment authorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>The prescriber submits to the Department adequate documentation demonstrating that the service to be authorized is medically necessary; and</text> </paragraph> <paragraph num="(3)"> <text>A request for supplies or equipment on the list of approved items, or on the list but without a specified maximum Program price, is accompanied by the manufacturer's suggested retail price or an invoice or other documentation of the wholesale cost, whichever is applicable under Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Prepayment authorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—G of this regulation.</text> </paragraph> <paragraph num="I."> <text>The Department is not responsible for any reimbursement to a provider for any service provided which requires prepayment authorization unless the authorization has been granted by the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures shall be as set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>The provider’s billed charges to the Program may not exceed the provider’s customary charge. If the item is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with the provisions of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall give the Program the full advantage of any and all manufacturer's warranty offered on the item.</text> </paragraph> <paragraph num="D."> <text>Effective July 1, 2022, the Department shall pay providers 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare rate established January 1 of each year for prosthetic devices. For prosthetic devices for which Medicare has not established a rate, the Department shall pay providers the manufacturer’s suggested retail price of the item, less 26.5 percent. The payment shall include all fitting, dispensing, and follow-up care.</text> </paragraph> <paragraph num="E."> <text>Charges for osteogenesis stimulators shall include all follow-up care, batteries, repairs, and replacement parts within the limitations of Regulation .05E and F, at the following times:</text> <paragraph num="(1)"> <text>Initial date of service;</text> </paragraph> <paragraph num="(2)"> <text>After 6-week evaluation;</text> </paragraph> <paragraph num="(3)"> <text>After 3-month evaluation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>With the exception of items free to individuals not covered by Medicaid, the Department shall reimburse providers for the purchase of covered services at the lesser of the provider’s customary charge or:</text> <paragraph num="(1)"> <text>For the purchase of items for which Medicare has established a rate:</text> <paragraph num="(a)"> <text>Disposable medical supplies and durable medical equipment other than enteral nutritional products and enteral and parenteral therapy supplies at 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate established January 1 of each year;</text> </paragraph> <paragraph num="(b)"> <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(1) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Enteral and parenteral therapy supplies as established in §F-1(2) of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>For medical equipment for which Medicare has established a rental rate, the purchase price shall be 10 times the lowest rural, non-rural, or competitive bidding area (CBA) Medicare monthly rental rate.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For the purchase of items for which Medicare has not established a rate:</text> <paragraph num="(a)"> <text>Disposable medical supplies not otherwise specified in this section are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or the provider’s wholesale cost plus 37.2 percent;</text> </paragraph> <paragraph num="(b)"> <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(3) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Enteral and parenteral therapy supplies as established in §F-1(4) of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Incontinence supplies at the provider's wholesale cost plus 25 percent;</text> </paragraph> <paragraph num="(e)"> <text>Customized equipment at the provider's choice of the manufacturer's suggested retail price minus 30 percent or provider's wholesale cost plus 40 percent; and</text> </paragraph> <paragraph num="(f)"> <text>Durable medical equipment, not otherwise specified in this section, are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or provider’s wholesale cost plus 27.4 percent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F-1."> <text>Enteral Nutritional Product and Enteral and Parenteral Supply Reimbursement Rates Effective February 1, 2021.</text> <paragraph num="(1)"> <text>Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:</text> </paragraph> <paragraph num="(2)"> <text>Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:</text> </paragraph> <paragraph num="(3)"> <text>Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:</text> </paragraph> <paragraph num="(4)"> <text>Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall reimburse providers for the monthly rental of covered services as follows:</text> <paragraph num="(1)"> <text>For items for which Medicare has established a purchase rate, 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate divided over 10 months;</text> </paragraph> <paragraph num="(2)"> <text>For items for which Medicare has not established a purchase rate, items will be rented at the provider’s choice of:</text> <paragraph num="(a)"> <text>The manufacturer’s suggested retail price minus 41.2 percent, divided over 10 months; or</text> </paragraph> <paragraph num="(b)"> <text>The provider’s wholesale cost plus 27.4 percent, divided over 10 months; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>After 10 months of monthly rental, the item will be considered purchased.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department reserves the right to prorate the monthly rental amount for daily rentals.</text> </paragraph> <paragraph num="I."> <text>The Department shall pay for repairs to purchased durable medical equipment according to the following:</text> <paragraph num="(1)"> <text>The provider's choice of wholesale cost plus 37.2 percent or the manufacturer's suggested retail price minus 31.4 percent to the provider for all materials;</text> </paragraph> <paragraph num="(2)"> <text>Labor costs shall be billed in quarter hour increments using the appropriate procedure code and shall be reimbursed the lesser of:</text> <paragraph num="(a)"> <text>The supplier’s customary charge unless the service is free to individual not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate specified in the Medicaid Durable Medical Equipment Program's approved list of items.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>The determination to purchase or rent medical equipment shall be based on the prescriber's best faith estimate of length of time the equipment will be needed by the recipient. When the equipment is ordered for:</text> <paragraph num="(1)"> <text>10 or more months, the provider shall charge the Program for a purchase, unless:</text> <paragraph num="(a)"> <text>The items cannot be purchased, in which case the items shall continue to be rented for the duration of their need at the amount determined on the fee schedule or elsewhere in this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>There is justification to request a rental rather than a purchase of the item, and a request for prepayment authorization is submitted to and approved by the Program before the submission of the invoice for the item; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Less than 10 months, the provider shall charge the Program for rental of the item for the duration of the medical necessity except that:</text> <paragraph num="(a)"> <text>If the equipment is still medically necessary after 10 months of rental and the equipment is purchasable, the tenth rental payment is the final rental payment, and the equipment is considered purchased by the Program; or</text> </paragraph> <paragraph num="(b)"> <text>If there is justification to request a purchase rather than a rental of the item, a request for prepayment authorization shall be submitted to the Program and approved by the Program before the submission of the invoice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Medical equipment that is determined by the Department to require frequent and substantial servicing in order to avoid risk to the recipient's health shall be reimbursed at the rental rate in accordance with §G of this regulation until either the equipment is no longer medically necessary or the recipient is no longer eligible for Medical Assistance fee-for-service benefits.</text> </paragraph> <paragraph num="L."> <text>Every 90 days during the rental term the provider shall obtain recertification from the prescriber and keep in the provider's records a recertification of continuous medical need that the equipment is still medically necessary.</text> </paragraph> <paragraph num="M."> <text>The Department shall review purchase prices and rental charges for items for which Medicare has not established a rate at least every 3 years.</text> </paragraph> <paragraph num="N."> <text>If services are provided under a contract pursuant to Regulation .04F of this chapter, the Department shall reimburse the contracted vendor or vendors at rates and under conditions in accordance with the contract or contracts.</text> </paragraph> <paragraph num="O."> <text>Once an item has been purchased in full, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered by the Department or its designee. The Department may arrange for the provision of recycled equipment under an exclusive contract with a vendor or vendors that have been awarded in accordance with State regulations and policies governing contracts and procurement. The Department also may determine the geographical scope and the types of equipment, or both, to be included under the contract. The vendor or vendors shall be reimbursed at a rate and under terms established in the contract.</text> </paragraph> <paragraph num="P."> <text>For equipment that is not covered under a contract awarded under §O of this regulation, the provider that originally furnished the equipment to the recipient shall recover the equipment after it is no longer required by the recipient. After recovery of the equipment, the provider shall determine the viability of recycling the item and, upon its reissue, bill the Program 75 percent of the Program's original payment.</text> </paragraph> <paragraph num="Q."> <text>To the extent that the Department chooses to use an exclusive contract to provide recycled equipment under §O of this regulation, the Department shall reimburse providers for evaluation of a recipient for equipment that is subsequently provided through the Department's recycling program at 11.5 percent of the reimbursement rate established under §§AH of this regulation.</text> </paragraph> <paragraph num="R."> <text>The Department will authorize payment on Medicare claims if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="S."> <text>Supplemental payments on Medicare claims are made subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance will be paid in full;</text> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but by the Program, will be paid in accordance with the limitations of §I of this regulation.</text> </paragraph> </paragraph> <paragraph num="T."> <text>The provider may not bill the Department for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone; or</text> </paragraph> <paragraph num="(4)"> <text>Fitting, dispensing, or follow-up care except as set forth in §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="U."> <text>The methodology in §§F and G of this regulation shall be used to establish a list of approved items with the corresponding procedure code, maximum allowable reimbursement amount, useful life expectancy, and maximum number allowed. This list shall be made available to the providers for ease of administration of the Program. When the approved list of items contains a price for a procedure code, the Department shall reimburse providers the lesser of the price listed in the approved list or the provider’s customary charge unless the service is free to individuals not covered by Medicaid.</text> </paragraph> <paragraph num="V."> <text>The provider shall ensure that the equipment is in good working condition both throughout the rental of the equipment and at the end of the rental term.</text> </paragraph> <paragraph num="W."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="X."> <text>Durable medical equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing medical equipment and supplies.</text> </paragraph> <paragraph num="Y."> <text>Refills.</text> <paragraph num="(1)"> <text>For durable medical equipment or disposable supplies, or both that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall maintain documentation of contact and confirmation of any changes and modifications of the order for audit purposes.</text> </paragraph> <paragraph num="(3)"> <text>The provider shall contact the recipient or designee regarding refills no earlier than 7 business days before the anticipated delivery date or anticipated shipping date.</text> </paragraph> <paragraph num="(4)"> <text>For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product.</text> </paragraph> </paragraph> <paragraph num="Z."> <text>The disposable medical supplies or durable medical equipment provider shall identify the individual who ordered the disposable medical supplies and durable medical equipment by recording the individual practitioners National Provider Identifier (NPI) number on the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures shall be as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>State Regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 8, 1980 (7:3 Md. R. 264)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 8, 1980 (7:3 Md. R. 264) and April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 26, 1981 (8:13 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 11, 1988 (15:13 Md. R. 1553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572); May 29, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 1, 1987 (14:13 Md. R. 1473); May 29, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); May 29, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective July 2, 1984 (11:13 Md. R. 1176); August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F G adopted effective June 2, 1986 (13:11 Md. R. 1273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H adopted effective March 23, 1987 (14:6 Md. R. 715)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655); May 29, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A-3 and A-4 adopted, B amended effective July 1, 1987 (14:13 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B and D amended effective June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273);</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); May 30, 1988 (15:11 Md. R. 1331); July 11, 1988 (15:13 Md. R. 1553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective May 30, 1988 (15:11 Md. R. 1331)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D-1 amended effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); May 29, 1989 (16:10 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2392); amended permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-1 repealed effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-1 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C-2 adopted effective July 1, 1987 (14:13 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective October 1, 1983 (10:19 Md. R. 1691); June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); July 1, 1988 (15:13 Md. R. 1554); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, F-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625); June 2, 1986 (13:11 Md. R. 1273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F-2 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004))</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 16, 1992 (19:5 Md. R. 577)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 16, 1998 (25:23 Md. R. 1696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 30, 2012 (39:8 Md. R. 533); June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568); January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470); June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective April 30, 2012 (39:8 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K amended effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05L adopted effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation05M-Q amended effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 7, 2002 (28:26 Md. R. 2272); August 1, 2005 (32:15 Md. R. 1320); October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A,B amended effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective September 29, 2003 (30:19 Md. R. 1331); June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 19, 2010 (37:8 Md. R. 615); April 30, 2012 (39:8 Md. R. 534); July 4, 2016 (43:13 Md. R. 712); October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective February 9, 2009 (36:3 Md. R. 208); February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F-1 adopted effective June 14, 2021 (48:12 Md. R. 470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Z adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> </annotations> </chapter> <chapter num="13" heading="Ambulance and Wheelchair Van Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(2)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(3)"> <text>“Medical Care Programs” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(4)"> <text>“Medicare” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(5)"> <text>“Program” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(6)"> <text>“Provider” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(7)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <text>Providers shall meet all licensing requirements as set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Comply with the conditions for participation as set forth in COMAR 10.09.36;</text> </paragraph> <paragraph num="B."> <text>Be approved as a provider of ambulance services by Medicare.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The program covers copayment and deductible payments for Medicare-approved services to Maryland Medical Assistance recipients.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover any payment for service other than coinsurance and deductible as approved by Medicare.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Repealed." /> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures for this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>The Department will authorize payment on Medicare ambulance claims if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>The services are covered by the Program;</text> </paragraph> <paragraph num="(4)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines;</text> </paragraph> <paragraph num="(5)"> <text>Medicare has determined that services were medically justified.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department will make supplemental payment on Medicare ambulance claims, subject to the following conditions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance will be paid in full.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement for this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions for this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures for this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>The interpretive regulation for this chapter is set forth in COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised September 23, 1977 (4:20 Md. R. 1545)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 23, 1989 (16:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B and .05I amended, and .05J adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C-1 adopted and D amended effective July 1, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); January 23, 1989 (16:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 1, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 1, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 23, 1989 (16:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-1 adopted, E and G amended effective July 1, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-1 amended effective February 22, 1988 (15:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective July 1, 1978 (5:12 Md. R. 968); January 1, 1980 (6:26 Md. R. 2075); July 1, 1980 (7:13 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1123); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 18, 1994 (21:14 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 18, 1994 (21:14 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective July 18, 1994 (21:14 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 18, 1994 (21:14 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective July 18, 1994 (21:14 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 18, 1994 (21:14 Md. R. 1229)</annotation> </annotations> </chapter> <chapter num="14" heading="Vision Care Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition cost” means actual cost of a product to a provider.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(4)"> <text>“Diagnostically certified optometrist” means a licensed optometrist who is certified by the Board to administer topical ocular diagnostic pharmaceutical agents to the extent permitted under Health Occupations Article, §11-404, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“EPSDT partial screen” means less than the complete package of various screening procedures required by the State Periodicity Schedule that an EPSDT participant receives at a given age.</text> </paragraph> <paragraph num="(6)"> <text>“EPSDT screen” means EPSDT screen as defined in COMAR 10.09.23.01.</text> </paragraph> <paragraph num="(7)"> <text>“Invoice” means a form designated by the Department for use by providers in submitting bills for payment.</text> </paragraph> <paragraph num="(8)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Ophthalmologist” means a physician skilled in diseases of the eye.</text> </paragraph> <paragraph num="(10)"> <text>“Ophthalmic lenses or optical aids” means a lens, contact lens, prism, or vision aid which has a therapeutic effect on a patient, or which will contribute to the visual welfare of a patient.</text> </paragraph> <paragraph num="(11)"> <text>“Optician” means an individual, partnership, or company which meets applicable licensing requirements as a qualified grinder or dispenser of ophthalmic lenses or optical aids, and which is capable of translating, filling, and adapting ophthalmic prescriptions, products, and accessories.</text> </paragraph> <paragraph num="(12)"> <text>“Optometric clinic or center” means a facility, which provides services for patients under the supervision of a licensed optometrist.</text> </paragraph> <paragraph num="(13)"> <text>Optometric Examination.</text> <paragraph num="(a)"> <text>“Optometric examination” means a series of tests and measurements used to determine the extent of visual impairment, or the correction required to improve visual acuity, performed by a licensed optometrist.</text> </paragraph> <paragraph num="(b)"> <text>“Optometric examination” includes as a minimum:</text> <paragraph num="(i)"> <text>Reviewing a patient's history, past prescriptions, and specifications when available;</text> </paragraph> <paragraph num="(ii)"> <text>Visual analysis;</text> </paragraph> <paragraph num="(iii)"> <text>Ophthalmoscopy of internal eye;</text> </paragraph> <paragraph num="(iv)"> <text>Tonometry without anesthetic when indicated or for a patient 40 years old or older;</text> </paragraph> <paragraph num="(v)"> <text>Muscle balance examination;</text> </paragraph> <paragraph num="(vi)"> <text>Gross visual field testing when indicated;</text> </paragraph> <paragraph num="(vii)"> <text>Writing of lens formula and other prescription data when needed, as well as specific instructions for future care;</text> </paragraph> <paragraph num="(viii)"> <text>Other tests when indicated by §B(12)(b)(i)—(vii) of this regulation; and</text> </paragraph> <paragraph num="(ix)"> <text>Subsequent progress evaluations when indicated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Optometrist” means an individual who is licensed by the Board to practice optometry or by the state in which the service is rendered.</text> </paragraph> <paragraph num="(15)"> <text>“Orthoptic treatment” means the use of instruments to measure and enhance the binocular coordination of the eyes (a category of “visual training”).</text> </paragraph> <paragraph num="(16)"> <text>Practice Optometry.</text> <paragraph num="(a)"> <text>“Practice optometry” means, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland, to use any means known in the science of optics or eye care, except surgery, to:</text> <paragraph num="(i)"> <text>Detect, diagnose, and treat any optical or diseased condition in the human eye;</text> </paragraph> <paragraph num="(ii)"> <text>Prescribe eyeglasses or lenses to correct any optical or visual condition in the human eye;</text> </paragraph> <paragraph num="(iii)"> <text>Give advice or direction on the fitness or adaptation of eyeglasses or lenses to an individual for the correction or relief of a condition for which eyeglasses or lenses are worn; and</text> </paragraph> <paragraph num="(iv)"> <text>Use, or permit the use of an instrument, test card, test type, test eyeglasses, test lenses, or other device to aid in choosing eyeglasses or lenses for an individual to wear.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice optometry” includes, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland:</text> <paragraph num="(i)"> <text>The administration of topical ocular diagnostic pharmaceutical agents;</text> </paragraph> <paragraph num="(ii)"> <text>The administration and prescription of therapeutic pharmaceutical agents; and</text> </paragraph> <paragraph num="(iii)"> <text>The removal of superficial foreign bodies from the cornea and conjunctiva.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Preauthorization” means an approval required from the Department or its designee before providing services.</text> </paragraph> <paragraph num="(18)"> <text>“Prescriber” means a physician or optometrist licensed to prescribe optical aids, and authorized by the Department to participate in the Program.</text> </paragraph> <paragraph num="(19)"> <text>“Prescription” means a written order for treatment or optical aids, or both, signed by the prescriber.</text> </paragraph> <paragraph num="(20)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(21)"> <text>“Progress evaluation” means a follow-up visit, when indicated, to determine the effectiveness of an eye examination, prescription, or series of orthoptic treatments.</text> </paragraph> <paragraph num="(22)"> <text>“Provider” means a physician (when dispensing ophthalmic lenses or visual aids), optometrist, optometric clinic or center, or optician, recognized by the Department to participate in the Program.</text> </paragraph> <paragraph num="(23)"> <text>“Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(24)"> <text>“Routine adjustment” means an adjustment made to an optical aid other than an adjustment required because of damage.</text> </paragraph> <paragraph num="(25)"> <text>“Screening” means tests or measurements, other than an eye examination, performed to discover the possibility of difficulty in vision.</text> </paragraph> <paragraph num="(26)"> <text>“Therapeutically certified optometrist” means a licensed optometrist who is certified by the Board to administer or prescribe therapeutic pharmaceutical agents or remove superficial foreign bodies from a human eye, adnexa, or lacrimal system to the extent permitted under Health Occupations Article, §11-404.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“Visual training” means use of instruments or other means to measure and enhance the binocular coordination of the eyes and visual perceptual functions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>An optometrist shall be licensed to practice optometry in the state in which service is provided.</text> </paragraph> <paragraph num="B."> <text>An optician shall meet the legal requirements of the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>An ophthalmologist shall be licensed to practice medicine in the state in which the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Apply for participation in the Program using the application form designated by the Department;</text> </paragraph> <paragraph num="B."> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="C."> <text>Verify the recipient's eligibility;</text> </paragraph> <paragraph num="D."> <text>Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="E."> <text>Provide service without regard to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap;</text> </paragraph> <paragraph num="F."> <text>Not knowingly employ an optometrist, optician, or physician to provide services to Medical Assistance patients after that optometrist, optician, or physician has been disqualified from the Program, unless prior approval has been received from the Department.</text> </paragraph> <paragraph num="G."> <text>Accept payment by the Department as payment in full for services rendered and make no additional charge to any person or covered services;</text> </paragraph> <paragraph num="H."> <text>Use first quality materials that meet the criteria established by the Department;</text> </paragraph> <paragraph num="I."> <text>Place no restriction on a recipient's right to select providers of the recipient's choice;</text> </paragraph> <paragraph num="J."> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the recipient;</text> </paragraph> <paragraph num="K."> <text>Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The program covers the following vision care services:</text> <paragraph num="(1)"> <text>A maximum of one optometric examination every 2 years for recipients 21 years old or older and a maximum of one every year for recipients younger than 21 years old, to determine the extent of visual impairment or the correction required to improve visual acuity, unless the time limitations are waived by the Department, based on medical necessity;</text> </paragraph> <paragraph num="(2)"> <text>Subject to §B, of this regulation, a maximum of one pair of eyeglasses every year, unless the time limitations are waived by the Department, based on medical necessity;</text> </paragraph> <paragraph num="(3)"> <text>Examination and eyeglasses for a recipient with a medical condition, other than normal physiological change necessitating a change in eyeglasses (before the normal time limits specified in §§A and B of this regulation have been met) when a preauthorization has been procured;</text> </paragraph> <paragraph num="(4)"> <text>Visually necessary optometric care rendered by an optometrist when these services are:</text> <paragraph num="(a)"> <text>Provided by the optometrist or a licensed employee;</text> </paragraph> <paragraph num="(b)"> <text>Related to the patient's health needs as diagnostic, preventive, curative, palliative, or rehabilitative services; and</text> </paragraph> <paragraph num="(c)"> <text>Adequately described in the patient's record; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Optician services when the services are:</text> <paragraph num="(a)"> <text>Provided by the optician, optometrist, or ophthalmologist, or by an employee under the optician's, optometrist's, or ophthalmologist's supervision and control;</text> </paragraph> <paragraph num="(b)"> <text>Adequately described in the patient's record;</text> </paragraph> <paragraph num="(c)"> <text>Ordered or prescribed by an ophthalmologist or optometrist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Eyeglasses.</text> <paragraph num="(1)"> <text>The eyeglasses under §A(2) of this regulation shall have first quality, impact resistant lenses, except in cases where prescription requirements cannot be met with impact resistant lenses. Frames shall be made of fire-resistant, first-quality material.</text> </paragraph> <paragraph num="(2)"> <text>In order to be entitled to receive eyeglasses under §A(2) of this regulation, a recipient shall meet at least one of the following conditions:</text> <paragraph num="(a)"> <text>The recipient requires a diopter change of at least 0.50;</text> </paragraph> <paragraph num="(b)"> <text>The recipient requires a diopter correction of less than 0.50 and this has been preauthorized according to Regulation .06, of this chapter, based on medical necessity;</text> </paragraph> <paragraph num="(c)"> <text>The recipient's present eyeglasses have been damaged to the extent that they affect visual performance and cannot be repaired to effective performance standards, or are no longer usable due to a change in head size or anatomy; or</text> </paragraph> <paragraph num="(d)"> <text>The recipient's present eyeglasses have been lost or stolen.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The following are not covered:</text> <paragraph num="(1)"> <text>Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients 21 years old and older;</text> </paragraph> <paragraph num="(2)"> <text>Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients which were not ordered as a result of a full or partial EPSDT screen;</text> </paragraph> <paragraph num="(3)"> <text>Repairs, except when repairs to eyeglasses are more cost-effective than replacing with new eyeglasses;</text> </paragraph> <paragraph num="(4)"> <text>Combination or metal frames except when required for proper fit;</text> </paragraph> <paragraph num="(5)"> <text>Cost of travel by the provider;</text> </paragraph> <paragraph num="(6)"> <text>A general screening of a Medical Assistance population;</text> </paragraph> <paragraph num="(7)"> <text>Visual training sessions which do not include orthoptic treatment;</text> </paragraph> <paragraph num="(8)"> <text>Routine adjustment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents in strengths not greater than the strengths indicated:</text> <paragraph num="(1)"> <text>Agents directly or indirectly affecting the pupil of the eye, including the mydriatics and cycloplegics listed below:</text> <paragraph num="(a)"> <text>Phenylephrine hydrochloride (2.5 percent);</text> </paragraph> <paragraph num="(b)"> <text>Hydroxyamphetamine hydrobromide (1 percent);</text> </paragraph> <paragraph num="(c)"> <text>Cyclopentolate hydrochloride (0.5—2 percent);</text> </paragraph> <paragraph num="(d)"> <text>Tropicamide (0.5 and 1 percent);</text> </paragraph> <paragraph num="(e)"> <text>Cyclopentolate hydrochloride (0.2 percent) with Phenylephrine hydrochloride (1 percent);</text> </paragraph> <paragraph num="(f)"> <text>Dapiprazole hydrochloride (0.5 percent); and</text> </paragraph> <paragraph num="(g)"> <text>Hydroxyamphetamine hydrobromide (1 percent) and Tropicamide (0.25 percent); and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Agents directly or indirectly affecting the sensitivity of the cornea including the:</text> <paragraph num="(a)"> <text>Topical anesthetics listed below:</text> <paragraph num="(i)"> <text>Proparacaine hydrochloride (0.5 percent); and</text> </paragraph> <paragraph num="(ii)"> <text>Tetracaine hydrochloride (0.5 percent); and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Diagnostic topical anesthetic and dye combinations listed below:</text> <paragraph num="(i)"> <text>Benoxinate hydrochloride (0.4 percent) — Fluorescein sodium (0.25 percent); and</text> </paragraph> <paragraph num="(ii)"> <text>Proparacaine hydrochloride (0.5 percent) — Fluorescein sodium (0.25 percent).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An optometrist certified by the Board as qualified to administer and prescribe topical therapeutic pharmaceutical agents is limited to:</text> <paragraph num="(1)"> <text>Ocular antihistamines, decongestants, and combinations of them, excluding steroids;</text> </paragraph> <paragraph num="(2)"> <text>Ocular antiallergy pharmaceutical agents;</text> </paragraph> <paragraph num="(3)"> <text>Ocular antibiotics and combinations of ocular antibiotics, excluding specially formulated or fortified antibiotics;</text> </paragraph> <paragraph num="(4)"> <text>Anti-inflammatory agents, excluding steroids;</text> </paragraph> <paragraph num="(5)"> <text>Ocular lubricants and artificial tears;</text> </paragraph> <paragraph num="(6)"> <text>Tropicamide;</text> </paragraph> <paragraph num="(7)"> <text>Homatropine;</text> </paragraph> <paragraph num="(8)"> <text>Nonprescription drugs that are commercially available; and</text> </paragraph> <paragraph num="(9)"> <text>Primary open-angle glaucoma medications, in accordance with a written treatment plan developed jointly between the optometrist and an ophthalmologist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The following services require written preauthorization:</text> <paragraph num="(1)"> <text>Optometric examinations to determine the extent of visual impairment or the correction required to improve visual acuity before expiration of the normal time limitations;</text> </paragraph> <paragraph num="(2)"> <text>Replacement of eyeglasses due to medical necessity or because the eyeglasses were lost, stolen, or damaged before expiration of the normal time limitations;</text> </paragraph> <paragraph num="(3)"> <text>Contact lenses;</text> </paragraph> <paragraph num="(4)"> <text>Subnormal vision aid examination and fitting;</text> </paragraph> <paragraph num="(5)"> <text>Orthoptic treatment sessions;</text> </paragraph> <paragraph num="(6)"> <text>Plastic lenses costing more than equivalent glass lenses unless there are six or more diopters of spherical correction or three or more diopters of astigmatic correction;</text> </paragraph> <paragraph num="(7)"> <text>Absorptive lenses, except cataract;</text> </paragraph> <paragraph num="(8)"> <text>Ophthalmic lenses or optical aids when the diopter correction is less than:</text> <paragraph num="(a)"> <text>-0.50 D. sphere for myopia in the weakest meridian;</text> </paragraph> <paragraph num="(b)"> <text>+0.75 D. sphere for hyperopia in the weakest meridian;</text> </paragraph> <paragraph num="(c)"> <text>+0.75 additional for presbyopia;</text> </paragraph> <paragraph num="(d)"> <text>±0.75 D. cylinder for astigmatism;</text> </paragraph> <paragraph num="(e)"> <text>A change in axis of 5° for cylinders of 1.00 diopter or more;</text> </paragraph> <paragraph num="(f)"> <text>A total of 4 prism diopters lateral or a total of 1 prism diopters vertical.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Preauthorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>Program limitations are met;</text> </paragraph> <paragraph num="(3)"> <text>The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Preauthorization is valid only for services rendered or initiated within 60 days of the date issued.</text> </paragraph> <paragraph num="D."> <text>Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A — C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Form for Request for Payment.</text> <paragraph num="(1)"> <text>The provider shall submit a request for payment on the form designated by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The request for payment shall document the following, when applicable:</text> <paragraph num="(a)"> <text>Preauthorization;</text> </paragraph> <paragraph num="(b)"> <text>Prescriptions;</text> </paragraph> <paragraph num="(c)"> <text>Need for combination or metal frame;</text> </paragraph> <paragraph num="(d)"> <text>Laboratory invoices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider’s customary charge to the general public for similar professional services. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §F of this regulation;and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall charge acquisition cost for eyeglass frames, eyeglass lenses, contact lenses, and other optical aids.</text> </paragraph> <paragraph num="E."> <text>Vision care services are reimbursed according to COMAR 10.09.23.01-1.</text> </paragraph> <paragraph num="F."> <text>The Department will pay professional fees for covered services at the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department's fee schedule.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department will pay for materials at acquisition costs not to exceed the maximums established by the Department.</text> </paragraph> <paragraph num="H."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Supplemental payment on Medicare claims is made subject to the limitations of the State budget and the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but covered by the Program, according to §E, of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The provider may not bill the Department for:</text> <paragraph num="(1)"> <text>Services rendered by mail or telephone;</text> </paragraph> <paragraph num="(2)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(3)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a recipient's patient record when requested by another licensed provider on behalf of the recipient.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Department's payment for lenses, frames, case, fitting, and dispensing covers any routine follow-up and adjustments for 60 days, and no additional fees will be paid.</text> </paragraph> <paragraph num="L."> <text>The Department will make no direct payment to the recipient.</text> </paragraph> <paragraph num="M."> <text>Payment for contact lenses is made as follows:</text> <paragraph num="(1)"> <text>For the prescription, fitting, training, and adaptation of contact lenses which includes the:</text> <paragraph num="(a)"> <text>Specification of optical and physical characteristics;</text> </paragraph> <paragraph num="(b)"> <text>Fitting of lenses to the wearer;</text> </paragraph> <paragraph num="(c)"> <text>Training of the wearer;</text> </paragraph> <paragraph num="(d)"> <text>Incidental revision of the lenses during training; and</text> </paragraph> <paragraph num="(e)"> <text>Adaptation of the lenses to the wearer;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For the supply of contact lenses; and</text> </paragraph> <paragraph num="(3)"> <text>For the follow-up of successfully fitted extended wear lenses.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>A provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, ophthalmologist, optometrist, optician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="D."> <text>A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised September 14, 1977 (4:19 Md. R. 1469)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .04, and .05 amended as an emergency provision effective January 1, 1993 (20:2 Md. R. 108); amended permanently effective July 1, 1993 (20:12 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective March 12, 1984 (11:5 Md. R. 463)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01J amended effective January 1, 1983 (9:25 Md. R. 2483)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, I—K amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J amended effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A and B amended effective January 1, 1983 (9:25 Md. R. 2483)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 17, 1981 (8:8 Md. R. 721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 10, 2005 (32:20 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 29, 1999 (26:24 Md. R. 1858); October 10, 2005 (32:20 Md. R. 1655); July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective April 17, 1981 (8:8 Md. R. 721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective August 10, 1987 (14:16 Md. R. 1774); January 2, 1995 (21:26 Md. R. 2186)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625); March 24, 2008 (35:6 Md. R. 698); January 12, 2009 (36:1 Md. R. 21); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> </annotations> </chapter> <chapter num="15" heading="Podiatry Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Ambulatory surgical center” means any distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency services” means treatment for traumatic injury or infection other than athlete's foot or chronic mycotic infection of the nail bed.</text> </paragraph> <paragraph num="(5)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(6)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(7)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(8)"> <text>“Medicare” means the insurance program administered by the Federal Government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq.</text> </paragraph> <paragraph num="(9)"> <text>“Nursing facility” means a skilled nursing facility certified for participation pursuant to Title XVIII or Title XIX of the Social Security Act, or an intermediate care facility certified for participation pursuant to Title XIX of the Social Security Act, which has entered into a provider agreement with the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(11)"> <text>“Personal hygiene care” means routine hygienic care in the absence of pathology.</text> </paragraph> <paragraph num="(12)"> <text>“Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered.</text> </paragraph> <paragraph num="(13)"> <text>Practice Podiatry.</text> <paragraph num="(a)"> <text>“Practice podiatry” means to diagnose or surgically, medically, or mechanically treat any ailment of the:</text> <paragraph num="(i)"> <text>Human foot or ankle;</text> </paragraph> <paragraph num="(ii)"> <text>Anatomical structures that attach to the human foot; or</text> </paragraph> <paragraph num="(iii)"> <text>Soft tissue below the midcalf.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice podiatry” does not include:</text> <paragraph num="(i)"> <text>Surgical treatment of acute ankle fracture; or</text> </paragraph> <paragraph num="(ii)"> <text>Administration of an anesthetic, other than a local anesthetic.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Preauthorization” means an approval required from the Department or its designee before rendering services.</text> </paragraph> <paragraph num="(15)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(16)"> <text>“Provider” means an individual, association, partnership, or an incorporated or unincorporated group of podiatrists, duly licensed to provide services for participants, and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(17)"> <text>“Routine care” means the cutting or removing of corns and calluses, and the trimming, cutting, clipping, or debriding of toenails.</text> </paragraph> <paragraph num="(18)"> <text>“Utilization control agent” means the organization responsible for reviewing the use of medical services to determine medical necessity and lengths of stay according to professional standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The Provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>In order to participate in the Program a podiatrist shall be licensed to practice podiatry in the state in which service is provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Comply with requirements set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a podiatry services provider require that the provider:</text> <paragraph num="(1)"> <text>Ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.03, or other applicable standards established by the state in which the service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Not knowingly employ another podiatrist to provide services to Medical Assistance patients after that podiatrist has been disqualified from the Program, unless prior approval has been received from the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services"> <text>The Program covers the following medically necessary services:</text> <paragraph num="A."> <text>Podiatric services rendered in the podiatrist's office, the participant's home, a hospital, a nursing facility, a free standing clinic, or elsewhere when these services are:</text> <paragraph num="(1)"> <text>Performed by the podiatrist or another licensed podiatrist in the podiatrist’s employ;</text> </paragraph> <paragraph num="(2)"> <text>Performed on the:</text> <paragraph num="(a)"> <text>Human foot or ankle;</text> </paragraph> <paragraph num="(b)"> <text>Anatomical structures that attach to the human foot; or</text> </paragraph> <paragraph num="(c)"> <text>Soft tissue below the midcalf;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services; and</text> </paragraph> <paragraph num="(4)"> <text>Adequately described on the participant’s medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Routine podiatric care rendered in an office, home, nursing home, or licensed assisted living facility for participants who have a metabolic, neurologic, or vascular disease affecting the lower extremities, including but not limited to:</text> <paragraph num="(1)"> <text>Arteriosclerosis obliterans (A.S.O., arteriosclerosis of the extremities, occlusive peripheral arteriosclerosis);</text> </paragraph> <paragraph num="(2)"> <text>Buerger’s disease (thromboangiitis obliterans);</text> </paragraph> <paragraph num="(3)"> <text>Peripheral neuropathies involving the feet, associated with:</text> <paragraph num="(a)"> <text>Traumatic injury;</text> </paragraph> <paragraph num="(b)"> <text>Leprosy or neurosyphilis; or</text> </paragraph> <paragraph num="(c)"> <text>Hereditary disorders, such as hereditary sensory radicular neuropathy, angiokeratoma corporis diffusum (Fabry’s) and amyloid neuropathy; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The following conditions, if the patient is under the active care of a doctor of medicine or osteopathy who documents the condition:</text> <paragraph num="(a)"> <text>Diabetes mellitus;</text> </paragraph> <paragraph num="(b)"> <text>Chronic thrombophlebitis;</text> </paragraph> <paragraph num="(c)"> <text>Peripheral neuropathies involving the feet, associated with:</text> <paragraph num="(i)"> <text>Malnutrition and vitamin deficiency such as malnutrition (general and pellagra), alcoholism, malabsorption (celiac disease and tropical sprue), and pernicious anemia;</text> </paragraph> <paragraph num="(ii)"> <text>Carcinoma;</text> </paragraph> <paragraph num="(iii)"> <text>Diabetes mellitus;</text> </paragraph> <paragraph num="(iv)"> <text>Drugs and toxins;</text> </paragraph> <paragraph num="(v)"> <text>Multiple sclerosis; or</text> </paragraph> <paragraph num="(vi)"> <text>Uremia (chronic renal disease).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Drugs dispensed by the podiatrist in an emergency or drugs which cannot be self-administered within the limitations of COMAR 10.09.03;</text> </paragraph> <paragraph num="D."> <text>Injectable drugs administered by the podiatrist within the limitations of COMAR 10.09.03;</text> </paragraph> <paragraph num="E."> <text>Medical equipment and supplies prescribed by the podiatrist within the limitations of COMAR 10.09.12; and</text> </paragraph> <paragraph num="F."> <text>Emergency services and related follow-up care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover the following under this chapter:</text> <paragraph num="(1)"> <text>Services which are not medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Investigational or experimental drugs or procedures;</text> </paragraph> <paragraph num="(3)"> <text>Services prohibited by the Maryland Podiatry Act or the State Board of Podiatric Medical Examiners;</text> </paragraph> <paragraph num="(4)"> <text>Services denied by Medicare as not medically justified;</text> </paragraph> <paragraph num="(5)"> <text>Drugs and supplies which are acquired by the podiatrist at no cost;</text> </paragraph> <paragraph num="(6)"> <text>Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record;</text> </paragraph> <paragraph num="(7)"> <text>More than one visit per day unless adequately documented in the patient's medical record as an emergency;</text> </paragraph> <paragraph num="(8)"> <text>Visits by or to the podiatrist solely for the purpose of the following:</text> <paragraph num="(a)"> <text>Prescription or drug pick-up;</text> </paragraph> <paragraph num="(b)"> <text>Collection of specimens for laboratory procedures, except by venipuncture, capillary or arterial puncture; and</text> </paragraph> <paragraph num="(c)"> <text>Interpretation of laboratory tests or panels;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(10)"> <text>Orthotics and inlays of any type and related services;</text> </paragraph> <paragraph num="(11)"> <text>Disposable medical supplies;</text> </paragraph> <paragraph num="(12)"> <text>Administration of anesthesia as a separate charge;</text> </paragraph> <paragraph num="(13)"> <text>Personal hygiene care;</text> </paragraph> <paragraph num="(14)"> <text>Routine care, except visits for participants who are diabetic or who have a vascular disease affecting the lower extremities;</text> </paragraph> <paragraph num="(15)"> <text>Non-surgical hospital visits;</text> </paragraph> <paragraph num="(16)"> <text>Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; and</text> </paragraph> <paragraph num="(17)"> <text>Podiatric inpatient hospital services rendered during an admission denied by the utilization control agent or during a period that is in excess of the length of stay authorized by the utilization control agent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Routine podiatric care is limited to one visit every 60 days for participants who have diabetes or peripheral vascular diseases that affect the lower extremities when rendered in the podiatrist's office, the participant’s home, or a nursing facility.</text> </paragraph> <paragraph num="C."> <text>A licensed podiatrist shall perform in a licensed hospital or ambulatory surgical center, subject to the provisions of Health-General Article, §19-351, Annotated Code of Maryland, all surgical procedures of the ankle below the level of the dermis, arthrodeses of two or more tarsal bones, and complete tarsal osteotomies. A licensed podiatrist who performs these procedures in an ambulatory surgical center shall:</text> <paragraph num="(1)"> <text>Have current privileges at a licensed hospital for the same procedures; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of the ambulatory surgical center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization."> <paragraph num="A."> <text>Preauthorization is required for any procedure not included in the current fee schedule.</text> </paragraph> <paragraph num="B."> <text>Preauthorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Preauthorization is valid only for services rendered or initiated within 90 days of the date issued.</text> </paragraph> <paragraph num="D."> <text>Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire claim or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit his request for payment on the form designated by the Department including all required documentation.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed.</text> </paragraph> <paragraph num="C."> <text>The provider shall bill the provider's customary fees, but may not bill a fee in excess of that charged the general public for similar services, except for injectable drugs and dispensed medical supplies, in which case the provider shall charge the Program the provider's acquisition cost. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program shall pay for medically necessary covered services at the lower of the provider's amount billed to the Program or the maximum reimbursement rates set forth in COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="E."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Supplemental payment on Medicare claims are made subject to the limitations of the State budget and the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but by the Program, according to §E above.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The provider may not bill the Department or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail;</text> </paragraph> <paragraph num="(4)"> <text>Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; or</text> </paragraph> <paragraph num="(5)"> <text>Photocopying of medical records when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Program will make no direct payment to participants.</text> </paragraph> <paragraph num="I."> <text>The Program shall reimburse providers for all laboratory services according to the fees established under COMAR 10.09.09.07 and for all radiological services under COMAR 10.09.02.07.</text> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>A provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, podiatrist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department may consult with the Peer Review Committee of the Maryland Podiatry Association. The Department will give consideration to the findings and recommendations of this group.</text> </paragraph> <paragraph num="D."> <text>The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="E."> <text>A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants that he or she no longer accepts Medical Assistance before rendering additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised September 14, 1977 (4:19 Md. R. 1470)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 14, 1999 (26:12 Md. R. 925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 2, 2006 (32:26 Md. R. 1997); August 27, 2007 (34:17 Md. R. 1507); July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01P adopted effective February 15, 1982 (9:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 15, 1982 (9:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 20, 1979 (6:8 Md. R. 656); September 19, 1980 (7:19 Md. R. 1806); June 14, 1999 (26:12 Md. R. 925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective September 19, 1980 (7:19 Md. R. 1806)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 24, 1997 (24:4 Md. R. 291); June 14, 1999 (26:12 Md. R. 925); June 24, 2002 (29:12 Md. R. 927); August 27, 2007 (34:17 Md. R. 1507); February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430); July 16, 2018 (45:14 Md. R. 696); August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective June 14, 1999 (26:12 Md. R. 925); January 2, 2006 (32:26 Md. R. 1997); July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended effective June 14, 1999 (26:12 Md. R. 925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended effective July 16, 2018 (45:14 Md. R. 696)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 16, 2018 (45:14 Md. R. 696)</annotation> </annotations> </chapter> <chapter num="16" heading="Behavioral Health Crisis Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative Services Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System.</text> </paragraph> <paragraph num="(2)"> <text>“Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department.</text> </paragraph> <paragraph num="(3)"> <text>“Core Service Agency” means the local mental health authority responsible for planning, managing, and monitoring public mental health services at the local level.</text> </paragraph> <paragraph num="(4)"> <text>“Crisis” means the experience of stress, emotional or behavioral symptoms, difficulties with substance use, or a traumatic event that compromises an individual’s ability to function within their current family and living situation, school, workplace, or community, as defined by the individual experiencing the crisis.</text> </paragraph> <paragraph num="(5)"> <text>“Crisis intervention” means the ability to perform or provide crisis assessment, crisis de-escalation, psychoeducation, brief behavioral support, and referral and linkage to appropriate services and supports.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed mental health professional” means a:</text> <paragraph num="(a)"> <text>Psychiatrist;</text> </paragraph> <paragraph num="(b)"> <text>Licensed psychologist;</text> </paragraph> <paragraph num="(c)"> <text>Psychiatric nurse practitioner (CRNP-PMH);</text> </paragraph> <paragraph num="(d)"> <text>Clinical nurse specialist in psychiatric and mental health nursing (APRN-PMH);</text> </paragraph> <paragraph num="(e)"> <text>Licensed certified social worker-clinical (LCSW-C);</text> </paragraph> <paragraph num="(f)"> <text>Licensed clinical alcohol and drug counselor (LCADC);</text> </paragraph> <paragraph num="(g)"> <text>Licensed clinical marriage and family therapist (LCMFT);</text> </paragraph> <paragraph num="(h)"> <text>Licensed clinical professional art therapist (LCPAT);</text> </paragraph> <paragraph num="(i)"> <text>Licensed clinical professional counselor (LCPC); or</text> </paragraph> <paragraph num="(j)"> <text>Properly supervised:</text> <paragraph num="(i)"> <text>Licensed master social worker (LMSW);</text> </paragraph> <paragraph num="(ii)"> <text>Licensed graduate alcohol and drug counselor (LGADC);</text> </paragraph> <paragraph num="(iii)"> <text>Licensed graduate marriage and family therapist (LGMFT);</text> </paragraph> <paragraph num="(iv)"> <text>Licensed graduate professional art therapist (LGPAT);</text> </paragraph> <paragraph num="(v)"> <text>Licensed graduate professional counselor (LGPC);</text> </paragraph> <paragraph num="(vi)"> <text>Licensed certified social worker (LCSW); or</text> </paragraph> <paragraph num="(vii)"> <text>Psychology associate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(9)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(10)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(11)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02, 10.63.01.05, and 10.63.02.03.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Provider Requirements for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program, a provider of behavioral health crisis services shall:</text> <paragraph num="(1)"> <text>Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06;</text> </paragraph> <paragraph num="(2)"> <text>Have clearly defined and written patient care policies;</text> </paragraph> <paragraph num="(3)"> <text>Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements:</text> <paragraph num="(a)"> <text>Includes the date of service with service start and end times;</text> </paragraph> <paragraph num="(b)"> <text>Includes the participant’s primary behavioral health complaint or reason for the visit;</text> </paragraph> <paragraph num="(c)"> <text>Includes a brief description of the service provided, including progress notes;</text> </paragraph> <paragraph num="(d)"> <text>Includes an official e-Signature, or a legible signature, along with the printed or typed name, and appropriate title of each individual providing services, including each separate member of the mobile crisis team;</text> </paragraph> <paragraph num="(e)"> <text>Is made available to the Department or its designee as requested; and</text> </paragraph> <paragraph num="(f)"> <text>Complies with all federal statutes and regulations, including but not limited to the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Part 2 and 45 CFR Parts 160 and 164.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To participate in the Program, a mobile crisis team provider shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.20;</text> </paragraph> <paragraph num="(2)"> <text>Be available to provide services outlined in Regulation .05 of this chapter 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(3)"> <text>Provide a timely response with a two-person team as described in COMAR 10.63.03.20;</text> </paragraph> <paragraph num="(4)"> <text>Comply with staffing and supervision requirements as described in COMAR 10.63.03.20F; and</text> </paragraph> <paragraph num="(5)"> <text>Ensure all crisis team staff members receive training as required and approved by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To participate in the Program, a behavioral health crisis stabilization center provider shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.21;</text> </paragraph> <paragraph num="(2)"> <text>Be open and accessible to walk-ins 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(3)"> <text>Comply with the staffing requirements described in COMAR 10.63.03.21E;</text> </paragraph> <paragraph num="(4)"> <text>Maintain the ability to initiate withdrawal management capabilities for all substances as well as initiate medication assisted treatment for opioid use disorder; and</text> </paragraph> <paragraph num="(5)"> <text>Equally accept individuals presenting due to an emergency petition and individuals presenting voluntarily.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participant Eligibility."> <paragraph num="A."> <text>A participant is eligible for mobile crisis team services and behavioral health crisis stabilization center services if they are experiencing a crisis as defined in Regulation .01 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A participant is eligible for behavioral health crisis services if the service is appropriate to the specific provider type listed in Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>The Department shall reimburse for the services in §§B—C of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary.</text> </paragraph> <paragraph num="B."> <text>Mobile crisis team services shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.20;</text> </paragraph> <paragraph num="(2)"> <text>Consist of an in-person response by at minimum a two-person team;</text> </paragraph> <paragraph num="(3)"> <text>Include an initial assessment by a licensed mental health professional, which may be rendered via telehealth only when the licensed mental health professional functions as a third team member;</text> </paragraph> <paragraph num="(4)"> <text>Involve the following interventions and objectives:</text> <paragraph num="(a)"> <text>Crisis intervention and stabilization of the individual’s behavioral health crisis;</text> </paragraph> <paragraph num="(b)"> <text>Safety planning; and</text> </paragraph> <paragraph num="(c)"> <text>Referrals to community supports, including behavioral health providers, health providers, or social and other services; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Include mobile crisis follow-up outreach by means of telephone, telehealth, or in-person contact with the individual served, family members, caregivers, or referred providers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Behavioral health crisis stabilization center services shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.21;</text> </paragraph> <paragraph num="(2)"> <text>Consist of an initial nursing assessment and physical exam by a registered nurse in collaboration with a physician or psychiatric nurse practitioner;</text> </paragraph> <paragraph num="(3)"> <text>Include an initial evaluation by an approved physician or psychiatric nurse practitioner in accordance with COMAR 10.63.03.21F;</text> </paragraph> <paragraph num="(4)"> <text>Include a crisis assessment completed by a licensed mental health professional; and</text> </paragraph> <paragraph num="(5)"> <text>Involve the following interventions and objectives:</text> <paragraph num="(a)"> <text>Crisis intervention and stabilization of the individual’s behavioral health crisis;</text> </paragraph> <paragraph num="(b)"> <text>Safety planning;</text> </paragraph> <paragraph num="(c)"> <text>Pharmacological interventions, including the ability to initiate withdrawal management capabilities for all substances, and initiate medications for medication assisted treatment for opioid use disorder; and</text> </paragraph> <paragraph num="(d)"> <text>Referrals to community-based services or to higher levels of care as clinically indicated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover the following:</text> <paragraph num="(1)"> <text>Services not delivered in compliance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Services not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Investigational or experimental drugs and procedures;</text> </paragraph> <paragraph num="(4)"> <text>Services solely for the purpose of:</text> <paragraph num="(a)"> <text>Prescribing medication;</text> </paragraph> <paragraph num="(b)"> <text>Administering medication;</text> </paragraph> <paragraph num="(c)"> <text>Drug or supply pick-up;</text> </paragraph> <paragraph num="(d)"> <text>Collecting laboratory specimens;</text> </paragraph> <paragraph num="(e)"> <text>Interpreting laboratory tests or panels; or</text> </paragraph> <paragraph num="(f)"> <text>Administering injections;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program;</text> </paragraph> <paragraph num="(6)"> <text>Services provided to or for the primary benefit of individuals other than the participant;</text> </paragraph> <paragraph num="(7)"> <text>Mobile crisis team services rendered by telehealth with the exception of those specified as permissible via telehealth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Behavioral health crisis stabilization center services rendered by telehealth with the exception of those specified in COMAR 10.63.03.21;</text> </paragraph> <paragraph num="(9)"> <text>Services provided to participants in a hospital inpatient setting; and</text> </paragraph> <paragraph num="(10)"> <text>Services rendered but not appropriately documented.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Providers may not be reimbursed by the Program for:</text> <paragraph num="(1)"> <text>Behavioral health crisis stabilization center services exceeding 23 hours 59 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Presumptive and definitive drug testing when billed by a behavioral health crisis stabilization center; or</text> </paragraph> <paragraph num="(3)"> <text>Transportation costs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>For dates of service June 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For services delivered through a mobile crisis team:</text> <paragraph num="(a)"> <text>Mobile crisis team services — $111.80 per 15-minute unit increment; and</text> </paragraph> <paragraph num="(b)"> <text>Mobile crisis follow-up outreach — $111.80 per 15-minute unit increment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For services delivered through a behavioral health crisis stabilization center:</text> <paragraph num="(a)"> <text>Behavioral health crisis stabilization services — $721.21 per diem; and</text> </paragraph> <paragraph num="(b)"> <text>Office-based evaluation and management services, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For services delivered through a mobile crisis team:</text> <paragraph num="(a)"> <text>Mobile crisis team services — $115.15 per 15-minute unit increment; and</text> </paragraph> <paragraph num="(b)"> <text>Mobile crisis follow-up outreach — $115.15 per 15-minute unit increment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For services delivered through a behavioral health crisis stabilization center:</text> <paragraph num="(a)"> <text>Behavioral Health Crisis Stabilization Center — $742.85 per diem; and</text> </paragraph> <paragraph num="(b)"> <text>Office-based evaluation and management services, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures for Providers."> <text>Appeal procedures for providers are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Appeal Rights — Denial of Services."> <text>Appeal procedures for applicants and participants are as set forth in COMAR 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 27, 2024 (51:10 Md. R. 525)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective July 7, 2025 (52:13 Md. R. 655)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D adopted effective July 7, 2025 (52:13 Md. R. 655)</annotation> </annotations> </chapter> <chapter num="17" heading="Physical Therapy Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(2)"> <text>“Direct supervision” means that a licensed physical therapist is personally present and immediately available within the same treatment area as the physical therapy assistant to give aid, direction, and instruction when physical therapy procedures or activities are performed.</text> </paragraph> <paragraph num="(3)"> <text>“Initial evaluation” means the determination of the participant's condition by taking a case history and the administration of appropriate tests on the first visit. Treatment provided at this visit is considered to be part of the initial evaluation.</text> </paragraph> <paragraph num="(4)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended.</text> </paragraph> <paragraph num="(5)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395—1395ccc.</text> </paragraph> <paragraph num="(7)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(8)"> <text>“Patient” means a person awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(9)"> <text>“Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners or similarly licensed or certified by the appropriate licensing body in the state or jurisdiction in which the service is provided and within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or within the scope established by the jurisdiction of the provided service.</text> </paragraph> <paragraph num="(10)"> <text>“Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a licensed physical therapist, and performing limited physical therapy procedures that are assigned by a licensed physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or who is otherwise similarly licensed or certified by the appropriate licensing body in the state or jurisdiction where the service is provided and performing therapy procedures within the scope established by the state or jurisdiction of license or certification.</text> </paragraph> <paragraph num="(11)"> <text>“Physical therapy aide” means a nonlicensed person in the employ of a physical therapist.</text> </paragraph> <paragraph num="(12)"> <text>“Physician” means an individual licensed to practice medicine by the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(13)"> <text>“Plan of care” means the plan of treatment aimed at achieving the anticipated functional goals.</text> </paragraph> <paragraph num="(14)"> <text>“Prescriber” means a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist licensed to prescribe physical therapy.</text> </paragraph> <paragraph num="(15)"> <text>“Program” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(16)"> <text>“Progress” means the measurable improvement as related to goals.</text> </paragraph> <paragraph num="(17)"> <text>“Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or similarly licensed or certified to provide health care services for participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(18)"> <text>“Treatment order” means a written prescription for physical therapy signed by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure and Certification Requirements."> <paragraph num="A."> <text>To provide services as a physical therapist under this chapter, a physical therapist shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice physical therapy, as defined in Health Occupations Article, Title 13, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction where the physical therapy services are performed.</text> </paragraph> <paragraph num="B."> <text>To provide services as a physical therapist assistant under this chapter, a physical therapist assistant shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice as a physical therapist assistant as defined:</text> <paragraph num="(1)"> <text>In Health Occupations Article, Title 13, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>By the appropriate licensing body in the jurisdiction where the physical therapy assistant services are performed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Comply with all requirements established in COMAR 10.09.36;</text> </paragraph> <paragraph num="B."> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; and</text> </paragraph> <paragraph num="C."> <text>Maintain the office and medical equipment so that they are free of hazards to the health and safety of participants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Physical Therapy Program covers medically necessary physical therapy services ordered in writing by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist when the services are:</text> <paragraph num="(1)"> <text>Provided by a licensed physical therapist or by a licensed physical therapist assistant under a licensed physical therapist's direct supervision;</text> </paragraph> <paragraph num="(2)"> <text>Provided in the provider’s office, the patient’s home, a domiciliary level facility, or via telehealth in accordance with COMAR 10.09.49 or other subregulatory guidance issued by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic, rehabilitative, or therapeutic, and directly related to the written treatment order;</text> </paragraph> <paragraph num="(4)"> <text>Of sufficient complexity and sophistication, or the condition of the patient is such, that the services of a physical therapist are required;</text> </paragraph> <paragraph num="(5)"> <text>Rendered pursuant to a written treatment order which:</text> <paragraph num="(a)"> <text>Is signed and dated by the prescriber;</text> </paragraph> <paragraph num="(b)"> <text>Specifies the following:</text> <paragraph num="(i)"> <text>Part or parts to be treated; and</text> </paragraph> <paragraph num="(ii)"> <text>Expected results of physical therapy treatments;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is kept on file by the therapist as a part of the patient's permanent record, subject to review by the Department or its designee; and</text> </paragraph> <paragraph num="(d)"> <text>Is not altered by the therapist unless:</text> <paragraph num="(i)"> <text>Medically indicated;</text> </paragraph> <paragraph num="(ii)"> <text>Signed by the therapist;</text> </paragraph> <paragraph num="(iii)"> <text>Necessary changes are made;</text> </paragraph> <paragraph num="(iv)"> <text>The prescriber is notified of the change; and</text> </paragraph> <paragraph num="(v)"> <text>The change is noted in the patient's record; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Recorded in the patient's permanent record which includes:</text> <paragraph num="(a)"> <text>The treatment order of the prescriber;</text> </paragraph> <paragraph num="(b)"> <text>The initial evaluation by the therapist and significant past history;</text> </paragraph> <paragraph num="(c)"> <text>All pertinent diagnoses and prognoses;</text> </paragraph> <paragraph num="(d)"> <text>Contraindications, if any; and</text> </paragraph> <paragraph num="(e)"> <text>Progress notes documented in accordance with the requirements listed in COMAR 10.38.03.02-1A(2), C, and D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Physical Therapy Program covers an initial evaluation, on a one-time-only basis, per condition, when the requirements of §A, of this regulation, are met.</text> </paragraph> <paragraph num="C."> <text>If the prescribing order exceeds 30 days, the therapist shall request a new order from the prescriber for continued therapy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover the following:</text> <paragraph num="(1)"> <text>Services provided in a facility or by a group where reimbursement for physical therapy is covered by another segment of the Program;</text> </paragraph> <paragraph num="(2)"> <text>Services performed by physical therapist assistants when not under the direct supervision of a physical therapist;</text> </paragraph> <paragraph num="(3)"> <text>Services performed by physical therapy aides; or</text> </paragraph> <paragraph num="(4)"> <text>Experimental treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physical therapist may only supervise two physical therapy assistants at a time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The provider shall certify on the invoice that the treatment order is on file and was in effect at the time that services were rendered.</text> </paragraph> <paragraph num="C."> <text>The provider shall specify on the invoice the type of treatment provided.</text> </paragraph> <paragraph num="D."> <text>A provider shall bill the Program the provider’s customary charge. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with the rate provisions of §E of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The services covered in this chapter are reimbursed according to COMAR 10.09.23.01-1.</text> </paragraph> <paragraph num="F."> <text>The Department will pay for covered services, the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department's fee schedule.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Supplemental payment on Medicare claims for patients is made subject to the limitations of the State budget and the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but covered by the Program, according to §F, in this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The provider may not bill the Department for:</text> <paragraph num="(1)"> <text>Services rendered by mail or telephone;</text> </paragraph> <paragraph num="(2)"> <text>Completion of forms and reports; or</text> </paragraph> <paragraph num="(3)"> <text>Broken or missed appointments.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="K."> <text>The Department may return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement for this chapter are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal and imposition of sanctions for this chapter are as set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>The Department may consult with a peer review committee approved by a local chapter of the American Physical Therapy Association. The Department will give consideration to the findings and recommendations of this group.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures for this chapter are set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>The interpretive regulation for this chapter is set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 11, 1980 (7:14 Md. R. 1349)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective October 1, 1982 (9:19 Md. R. 1895)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective July 1, 1982 (9:17 Md. R. 1698); emergency status expired September 30, 1982</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective July 1, 1990 (17:14 Md. R. 1755); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07L amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 and .07—.11 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .04, and .05 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 364); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 24, 2005 (32:21 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2018 (45:17 Md. R. 803)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 27, 2018 (45:17 Md. R. 803)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 27, 2018 (45:17 Md. R. 803); August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 27, 2018 (45:17 Md. R. 803)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D, F, I amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective November 14, 2011 (38:23 Md. R. 1421); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H amended effective August 27, 2018 (45:17 Md. R. 803)</annotation> </annotations> </chapter> <chapter num="18" heading="Oxygen and Related Respiratory Equipment Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Concentrator” means a device which removes nitrogen from ambient air, thus increasing the percentage of oxygen, and delivers the resulting oxygen-enhanced air to the patient.</text> </paragraph> <paragraph num="(2)"> <text>“Current stable arterial blood gas results” means stable arterial blood gas results on room air within 1 month before the requested date of submission of the form designated by the Department.</text> </paragraph> <paragraph num="(3)"> <text>“Demurrage” means a charge imposed by a provider for the detention of an oxygen cylinder or other equipment.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency services” means unscheduled deliveries or maintenance visits to the home or nursing home by the provider because of a threat to the patient's life caused by insufficient supply of oxygen or equipment malfunction.</text> </paragraph> <paragraph num="(6)"> <text>“Home” means the place of residence occupied by the recipient, other than a hospital or a nursing facility.</text> </paragraph> <paragraph num="(7)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-301 et seq., Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the State in which the service is provided.</text> </paragraph> <paragraph num="(8)"> <text>“Intermittent Positive Pressure Breathing (IPPB) Equipment” means an apparatus designed to force a combination of ambient air or medication, or both, into a patient's respiratory system.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(10)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(11)"> <text>“Nasal continuous positive airway pressure (NCPAP) system” means a noninvasive apparatus designed to maintain air or oxygen, or both, under constant positive pressure through the nose during sleep.</text> </paragraph> <paragraph num="(12)"> <text>“Nursing facility” means a Comprehensive Care Facility which falls within the jurisdiction of the Health-General Article, §19-301 et seq., Annotated Code of Maryland, or other applicable standards established by the State in which the service is provided.</text> </paragraph> <paragraph num="(13)"> <text>“Oxygen” means pure liquid or gaseous oxygen, not in combination with other medical gases, packaged in suitable safe containers for administration to patients.</text> </paragraph> <paragraph num="(14)"> <text>“Prepayment authorization” means the approval required from the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(15)"> <text>“Prescriber” means a physician licensed to prescribe oxygen and related respiratory equipment in the state in which the service is provided.</text> </paragraph> <paragraph num="(16)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(17)"> <text>“Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals who, through an appropriate agreement with the Department, has been identified as a Program supplier of oxygen and related respiratory equipment by the issuance of an individual account number.</text> </paragraph> <paragraph num="(18)"> <text>“Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(19)"> <text>“Related respiratory equipment” means accessories used to move, direct, measure, or control the flow of oxygen from its container, or from a concentrator, to the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="(Reserved)" /> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Unless exempt from Medicare accreditation requirements:</text> <paragraph num="(1)"> <text>Be accredited by a Medicare-approved accreditation organization;</text> </paragraph> <paragraph num="(2)"> <text>Effective November 1, 2011, provide documentation of:</text> <paragraph num="(a)"> <text>Accreditation; or</text> </paragraph> <paragraph num="(b)"> <text>Having submitted an application for accreditation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective April 1, 2012, be accredited or terminated from the Program;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Apply for participation in the Program using the application form designated by the Department;</text> </paragraph> <paragraph num="C."> <text>If located more than 25 miles from the border of Maryland, shall provide to the Program documentation demonstrating that the enrollment and screening requirements of 42 CFR Part 455, Subpart E have been performed within the 12 months preceding the application for initial enrollment or revalidation of enrollment by:</text> <paragraph num="(1)"> <text>A Medicare contractor; or</text> </paragraph> <paragraph num="(2)"> <text>The Medicaid agency or the Children’s Health Insurance Program of another state;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="E."> <text>Verify the recipient's eligibility;</text> </paragraph> <paragraph num="F."> <text>Maintain for a minimum of 6 years adequate records which are sufficient in detail to support the invoices submitted for payment, and make these records available upon request to the Department or its designee;</text> </paragraph> <paragraph num="G."> <text>Provide service without discrimination as to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap;</text> </paragraph> <paragraph num="H."> <text>Not knowingly employ a former Medicaid provider, or a former employee of a Medicaid provider, to provide service to Medical Assistance patients after that provider or employee has been disqualified from the Program, unless prior approval has been received from the Department;</text> </paragraph> <paragraph num="I."> <text>Accept payment by the Department as payment in full for services rendered, and make no additional charge to any person for covered services;</text> </paragraph> <paragraph num="J."> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient;</text> </paragraph> <paragraph num="K."> <text>Agree that if the Program denies payment due to late billing, he may not seek payment from the recipient;</text> </paragraph> <paragraph num="L."> <text>Place no restriction on a recipient's right to select providers of the recipient's choice;</text> </paragraph> <paragraph num="M."> <text>Have emergency services available on a 24 hour-a-day basis;</text> </paragraph> <paragraph num="N."> <text>Be prepared to furnish necessary maintenance and repairs to oxygen and related respiratory equipment;</text> </paragraph> <paragraph num="O."> <text>Insure on every visit to the patient that all oxygen and related respiratory equipment functions properly;</text> </paragraph> <paragraph num="P."> <text>Provide suitable identification, including a recent photograph, which employees who visit patients at home will carry on their person and display on request;</text> </paragraph> <paragraph num="Q."> <text>Agree to discontinue billing or remove equipment promptly, if the patient dies, is institutionalized, or otherwise ceases to require the oxygen;</text> </paragraph> <paragraph num="R."> <text>Provide an ancillary source of oxygen to last at least 24 hours when the primary source is a concentrator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The following medically necessary items and services are covered for pulmonary use in the patient's home or nursing facility pursuant to §§B, C, D, and E of this regulation:</text> <paragraph num="(1)"> <text>Rental or purchase for use in patient's home or nursing facility of:</text> <paragraph num="(a)"> <text>Oxygen, gaseous (tank contained);</text> </paragraph> <paragraph num="(b)"> <text>Oxygen, liquid.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Rental of concentrators.</text> </paragraph> <paragraph num="(3)"> <text>Rental or purchase of the following related respiratory equipment:</text> <paragraph num="(a)"> <text>Rental of equipment included in complete oxygen set-up:</text> <paragraph num="(i)"> <text>Flow meter;</text> </paragraph> <paragraph num="(ii)"> <text>Humidity jar;</text> </paragraph> <paragraph num="(iii)"> <text>Nasal cannula;</text> </paragraph> <paragraph num="(iv)"> <text>Oxygen face mask;</text> </paragraph> <paragraph num="(v)"> <text>Regulator;</text> </paragraph> <paragraph num="(vi)"> <text>Safety stand;</text> </paragraph> <paragraph num="(vii)"> <text>Tubing;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Rental of portable oxygen unit;</text> </paragraph> <paragraph num="(c)"> <text>Rental or purchase of the following tracheostomy equipment:</text> <paragraph num="(i)"> <text>Trach tubes;</text> </paragraph> <paragraph num="(ii)"> <text>Tracheostomy trays;</text> </paragraph> <paragraph num="(iii)"> <text>Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor;</text> </paragraph> <paragraph num="(iv)"> <text>Heater;</text> </paragraph> <paragraph num="(v)"> <text>Water trap;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Other related equipment:</text> <paragraph num="(i)"> <text>Rental or purchase of aerosol compressor (complete set-up) to include compressor unit, medication cup, connector fitting, tubing, hand-held nebulizer, and mouthpiece, face mask, or tracheostomy collar or T-tube;</text> </paragraph> <paragraph num="(ii)"> <text>Rental or purchase of ultrasonic nebulizer (complete set-up) to include ultrasonic aerosol chamber with blower, medication cup, connector fitting, corrugated tubing, and mouthpiece, face mask, or tracheostomy collar or T-tube;</text> </paragraph> <paragraph num="(iii)"> <text>Resuscitator bag, manual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include:</text> <paragraph num="(a)"> <text>Compressor;</text> </paragraph> <paragraph num="(b)"> <text>Medication cup;</text> </paragraph> <paragraph num="(c)"> <text>Nebulizer;</text> </paragraph> <paragraph num="(d)"> <text>Connector fitting;</text> </paragraph> <paragraph num="(e)"> <text>Corrugated tubing;</text> </paragraph> <paragraph num="(f)"> <text>Nebulizer hose;</text> </paragraph> <paragraph num="(g)"> <text>Exhalation hose;</text> </paragraph> <paragraph num="(h)"> <text>Exhalation valve; and</text> </paragraph> <paragraph num="(i)"> <text>Mouthpiece.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include:</text> <paragraph num="(a)"> <text>Flow generating device;</text> </paragraph> <paragraph num="(b)"> <text>Valve mechanism to maintain pressure;</text> </paragraph> <paragraph num="(c)"> <text>Nasal mask and headgear; and</text> </paragraph> <paragraph num="(d)"> <text>Tubing and reservoir.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Repairs to purchased respiratory equipment.</text> </paragraph> <paragraph num="(7)"> <text>Replacement items for purchased equipment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when:</text> <paragraph num="(1)"> <text>The patient's current stable arterial blood gas results (at rest, using room air) for PaO2 are 60 mm Hg or less after optimal treatment; or</text> </paragraph> <paragraph num="(2)"> <text>The patient’s saturation level is 88 percent or less on room air or less than 93 percent for patients younger than 21 years old; or</text> </paragraph> <paragraph num="(3)"> <text>The patient's:</text> <paragraph num="(a)"> <text>Baseline study demonstrates sleep apnea or disordered breathing events, or both, (hourly rates >30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation <85 percent by ear oximetry which is the equivalent to PaO2 <50 mm Hg); and</text> </paragraph> <paragraph num="(b)"> <text>Repeat study on supplemental oxygen demonstrates either a 30 percent reduction in the number of apneic episodes or disordered breathing events, or both, or improved oxyhemoglobin saturation (>85 percent by ear oximetry which is equivalent to PaO2 >50 mm Hg) throughout the night.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The items in §A(5) of this regulation are covered when the patient's:</text> <paragraph num="(1)"> <text>Baseline study demonstrates more than 30 episodes per hour of obstructive sleep apnea (OSA), each lasting 10 seconds or more, or other disordered breathing events (DBE's), with evidence of clinical impairment (that is, daytime hypersomnolence or cor pulmonale); and</text> </paragraph> <paragraph num="(2)"> <text>Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show:</text> <paragraph num="(1)"> <text>A vital capacity of less than 1.5 liters (with a normal FEV1; or</text> </paragraph> <paragraph num="(2)"> <text>An absolute FEV1 of 1.5 liters or less.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The items in §A(3)(d)(i) and (ii) of this regulation are covered when:</text> <paragraph num="(1)"> <text>The patient's pulmonary function studies show an FEV1/FVC percentage of 45 or less (calculated as FEV1 divided by FVC); or</text> </paragraph> <paragraph num="(2)"> <text>Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The items in §A(1)—(5) of this regulation are covered when they are ordered in writing, by a physician, including documentation that a face-to-face encounter occurred within 6 months before ordering prescribed services, as follows:</text> <paragraph num="(1)"> <text>The physician's initial order and plan of treatment shall include:</text> <paragraph num="(a)"> <text>When prescribing oxygen:</text> <paragraph num="(i)"> <text>Diagnosis and indication for oxygen use;</text> </paragraph> <paragraph num="(ii)"> <text>Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen);</text> </paragraph> <paragraph num="(iii)"> <text>Number of hours to be used during a 24-hour period;</text> </paragraph> <paragraph num="(iv)"> <text>Description of equipment to include route of administration;</text> </paragraph> <paragraph num="(v)"> <text>Rehabilitative goals;</text> </paragraph> <paragraph num="(vi)"> <text>Hospital discharge or clinical summary;</text> </paragraph> <paragraph num="(vii)"> <text>Current stable arterial blood gas results to include PaO2, PaCO2, and Ph on room air and on oxygen at rest, and, if prescribing portable oxygen, when exercising, or sleep apnea study results.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When prescribing aerosol equipment:</text> <paragraph num="(i)"> <text>Diagnosis and indication for use;</text> </paragraph> <paragraph num="(ii)"> <text>Number of hours to be used during a 24-hour period;</text> </paragraph> <paragraph num="(iii)"> <text>Description of equipment to include route of administration;</text> </paragraph> <paragraph num="(iv)"> <text>Rehabilitative goals;</text> </paragraph> <paragraph num="(v)"> <text>Hospital discharge or clinical summary;</text> </paragraph> <paragraph num="(vi)"> <text>Pulmonary function study results.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>When prescribing tracheostomy equipment:</text> <paragraph num="(i)"> <text>Diagnosis and indication for use;</text> </paragraph> <paragraph num="(ii)"> <text>Description of equipment to include quantity requested, period of time required, and approximate cost;</text> </paragraph> <paragraph num="(iii)"> <text>Rehabilitative goals.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>When prescribing an NCPAP system:</text> <paragraph num="(i)"> <text>Diagnosis and indication for use;</text> </paragraph> <paragraph num="(ii)"> <text>Specification of NCPAP fixed level;</text> </paragraph> <paragraph num="(iii)"> <text>Rehabilitative goals;</text> </paragraph> <paragraph num="(iv)"> <text>Clinical summary, including appropriate sleep studies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The physician's subsequent orders shall include:</text> <paragraph num="(a)"> <text>When prescribing oxygen for other than sleep apnea, an update of the items listed in §F(1)(a) of this regulation if the patient's condition regarding the need for oxygen has changed since the previous orders;</text> </paragraph> <paragraph num="(b)"> <text>When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation;</text> </paragraph> <paragraph num="(e)"> <text>When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within:</text> <paragraph num="(a)"> <text>One year of the effective date of the initial preauthorization; or</text> </paragraph> <paragraph num="(b)"> <text>At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period:</text> <paragraph num="(i)"> <text>Significant weight loss of more than 10—15 percent;</text> </paragraph> <paragraph num="(ii)"> <text>Surgical intervention on upper airway;</text> </paragraph> <paragraph num="(iii)"> <text>Tracheostomy;</text> </paragraph> <paragraph num="(iv)"> <text>Positive airway pressure.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover:</text> <paragraph num="(1)"> <text>Any service or items not identified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Demurrage;</text> </paragraph> <paragraph num="(3)"> <text>Charges for delivery;</text> </paragraph> <paragraph num="(4)"> <text>Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, air conditioners and room humidifiers;</text> </paragraph> <paragraph num="(5)"> <text>Items which are investigational or experimental in nature;</text> </paragraph> <paragraph num="(6)"> <text>Oxygen and related equipment not for pulmonary use;</text> </paragraph> <paragraph num="(7)"> <text>Pre-set oxygen for emergency use;</text> </paragraph> <paragraph num="(8)"> <text>Trach string or tape.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program places the following limitations upon covered services:</text> <paragraph num="(1)"> <text>Reimbursement for aerosol equipment will only be provided if a hand held nebulizer has been tried and is not successful, as indicated in the clinical summary;</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement for IPPB machine will only be authorized if the aerosol compressor with the nebulizer kit has been tried and is not successful, as indicated in the clinical summary;</text> </paragraph> <paragraph num="(3)"> <text>Reimbursement may not be made for:</text> <paragraph num="(a)"> <text>Repairs or replacement parts for rented items;</text> </paragraph> <paragraph num="(b)"> <text>Oxygen prescribed on an as-needed basis (PRN);</text> </paragraph> <paragraph num="(c)"> <text>Oxygen prescribed for stand-by purposes;</text> </paragraph> <paragraph num="(d)"> <text>Piped-in oxygen;</text> </paragraph> <paragraph num="(e)"> <text>Oxygen and related respiratory equipment and services provided in a facility or by a group when reimbursement is covered by another segment of the Program; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Payment for portable oxygen will be made only when:</text> <paragraph num="(a)"> <text>It is required in the pursuit of medical treatment; and</text> </paragraph> <paragraph num="(b)"> <text>The medical necessity is indicated for this type of system.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prepayment Authorization Requirements."> <paragraph num="A."> <text>The following items require a written prepayment authorization:</text> <paragraph num="(1)"> <text>Nasal continuous positive pressure (NCPAP) system;</text> </paragraph> <paragraph num="(2)"> <text>Custom made tracheostomy tubes; and</text> </paragraph> <paragraph num="(3)"> <text>Intermittent positive pressure breathing (IPPB) machine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prepayment authorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>Program limitations are met; and</text> </paragraph> <paragraph num="(3)"> <text>The Prescriber submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The prescriber shall submit requests for prepayment authorization in writing using the format and procedures designated by the Department.</text> </paragraph> <paragraph num="D."> <text>Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile of the completed prepayment authorization form shall be followed by a written request, using the original of the form, which shall be submitted immediately to the Department.</text> </paragraph> <paragraph num="E."> <text>Written prepayment authorization is valid for a period to be determined by the Program but not to exceed a maximum of 365 days beginning with the date of issue by the Program, and is contingent on the recipient's continuing eligibility.</text> </paragraph> <paragraph num="F."> <text>Prepayment authorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—E of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit request for payment on the forms designated by the Department, with attachments when applicable.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed and those submitted without required documentation.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider’s customary charge to the general public for similar items. If the item is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall reimburse providers for the purchase of covered services at the lowest of the provider’s customary charge:</text> <paragraph num="(1)"> <text>For items for which Medicare has established a rate:</text> <paragraph num="(a)"> <text>The Department shall pay providers 80 percent of the Medicare rates established on January 1 of each year for oxygen and respiratory equipment and supplies, which shall include all fitting, dispensing, and follow-up care; and</text> </paragraph> <paragraph num="(b)"> <text>For respiratory equipment for which Medicare has established a capped rental rate, the purchase price shall be 9 times the current Medicare monthly rental rate; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For items for which Medicare has not established a rate:</text> <paragraph num="(a)"> <text>Oxygen and respiratory supplies at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or the provider's wholesale cost plus 37.2 percent;</text> </paragraph> <paragraph num="(b)"> <text>Customized equipment or supplies at the provider's choice of the manufacturer's suggested retail price minus 30 percent or the provider's wholesale cost plus 40 percent; and</text> </paragraph> <paragraph num="(c)"> <text>Other oxygen and respiratory equipment at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or of the provider's wholesale cost plus 27.4 percent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall pay for repairs to purchased oxygen and respiratory equipment in accordance with the following:</text> <paragraph num="(1)"> <text>The provider's choice of wholesale cost plus 37.2 percent or manufacturer's suggested retail price minus 31.4 percent for all materials; and</text> </paragraph> <paragraph num="(2)"> <text>Reasonable charges for labor, not to exceed the customary charges for similar services in the provider’s area unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(3)"> <text>Actual charges for repairs done by other than the provider as evidenced by an invoice attached to the bill.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall only pay separately for the following replacement items for purchased respiratory equipment, and all other replacement items shall be included in repairs and will be reimbursed according to §E of this regulation:</text> <paragraph num="(1)"> <text>Mouthpiece;</text> </paragraph> <paragraph num="(2)"> <text>Face mask;</text> </paragraph> <paragraph num="(3)"> <text>Tracheostomy collar or T-tube.</text> </paragraph> </paragraph> <paragraph num="G."> <text>When any individual item or combination of items are provided as part of a complete setup, they may not be invoiced in the Program separately, but under complete setup procedure codes as listed in the fee schedule, except for replacement items as listed in §F of this regulation.</text> </paragraph> <paragraph num="H."> <text>The Program will approve for payment the least expensive mode of oxygen which is medically suited for the patient's condition.</text> </paragraph> <paragraph num="I."> <text>The Program will determine, based upon expected duration of medical need, whether oxygen related equipment will be purchased or rented. Once an item has been purchased and paid for in full, and if the Program has contributed in full or in part to the purchase, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered at the option of the Department.</text> </paragraph> <paragraph num="J."> <text>Supplemental payment on Medicare claims is made subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Co-insurance will be paid in full;</text> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare but by the Program will be paid in accordance with the limitations of §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Department will authorize payment on Medicare claims if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that services were medically justified;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The Department may not make direct payments to recipients.</text> </paragraph> <paragraph num="M."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Services rendered by mail or telephone;</text> </paragraph> <paragraph num="(2)"> <text>Completion of forms or reports; or</text> </paragraph> <paragraph num="(3)"> <text>Broken or missed appointments.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="O."> <text>Oxygen and respiratory equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing oxygen and respiratory equipment and supplies.</text> </paragraph> <paragraph num="P."> <text>Refills.</text> <paragraph num="(1)"> <text>For oxygen and respiratory equipment and supplies that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall contact recipient or designee regarding the refills no earlier than 7 days before the delivery and shipping date.</text> </paragraph> <paragraph num="(3)"> <text>For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance or other coverage, or if any other person is obligated either legally or contractually to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="D."> <text>A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1984 (10:25 Md. R. 2268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109); April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective May 29, 1989 (16:10 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P, .05, .06F, and .07D, F, G amended effective November 5, 1984 (11:22 Md. R. 1899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective September 11, 2017 (44:18 Md. R. 866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, F amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 2, 1988 (15:9 Md. R. 1108); April 5, 2010 (37:7 Md. R. 570); September 11, 2017 (44:18 Md. R. 866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 27, 2003 (30:21 Md. R. 1529); April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 5, 2010 (37:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, E, M amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective August 12, 1985 (12:16 Md. R. 1606)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective May 2, 1988 (15:9 Md. R. 1108); October 27, 2003 (30:21 Md. R. 1529); April 2, 2012 (39:6 Md. R. 408): February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07O amended effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07O amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> </annotations> </chapter> <chapter num="19" heading="Transportation Grants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the administration of grants to counties, municipal corporations, and nonprofit organizations for the provision of safety-net transportation services to Medical Assistance Program recipients. The grant funds are to be used by grantees to:</text> <paragraph num="A."> <text>Screen requests for transportation by recipients;</text> </paragraph> <paragraph num="B."> <text>Arrange for transportation;</text> </paragraph> <paragraph num="C."> <text>Expand existing and develop new transportation resources; and</text> </paragraph> <paragraph num="D."> <text>Provide transportation services where no other transportation is available to the recipient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Ambulance” means a specially designed vehicle used for transporting the sick or injured, which has necessary patient care equipment including a stretcher, clean linens, first aid supplies, oxygen equipment, and, in addition, other safety and lifesaving equipment which may be required by State or local laws to classify the vehicle as an ambulance.</text> </paragraph> <paragraph num="(2)"> <text>“Attendant” means an individual needed to accompany a recipient who is unable to travel alone.</text> </paragraph> <paragraph num="(3)"> <text>“Department” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency” means a situation requiring prompt diagnosis and treatment of conditions having the potential of causing imminent disability or death.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency services” means services provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing health in jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions;</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part; or</text> </paragraph> <paragraph num="(d)"> <text>Development or continuance of severe pain.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Grantee” means a recipient of grant funds from the Department pursuant to this chapter.</text> </paragraph> <paragraph num="(7)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals.</text> </paragraph> <paragraph num="(8)"> <text>“Medicare” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(9)"> <text>“Necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(10)"> <text>“Nonambulatory” means a condition which renders a recipient physically unable to use a bus, taxicab, or private automobile in going to or from a hospital to receive needed medical treatment.</text> </paragraph> <paragraph num="(11)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(13)"> <text>“Wheelchair van” means a van equipped with either a lift tailgate or side lift which is used for loading patients who are nonambulatory but who do not require the use of equipment found in an ambulance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Procedure for Submission of Proposals."> <paragraph num="A."> <text>The Secretary shall request proposals for the award of transportation grants.</text> </paragraph> <paragraph num="B."> <text>An applicant shall include in the applicant's proposal a description of how the applicant intends to carry out the duties required by these regulations. At a minimum, the applicant shall include the following items in the proposal:</text> <paragraph num="(1)"> <text>The criteria which the applicant will use to determine the recipient's need for transportation services;</text> </paragraph> <paragraph num="(2)"> <text>A discussion of how the applicant will arrange and provide transportation;</text> </paragraph> <paragraph num="(3)"> <text>If applicable, a description of how volunteers will be recruited and reimbursed;</text> </paragraph> <paragraph num="(4)"> <text>The reporting methodology that will be used by the grantee; and</text> </paragraph> <paragraph num="(5)"> <text>An itemized budget for administrative costs, including:</text> <paragraph num="(a)"> <text>A staffing plan;</text> </paragraph> <paragraph num="(b)"> <text>Descriptions of individual job responsibilities and salaries;</text> </paragraph> <paragraph num="(c)"> <text>A budget form; and</text> </paragraph> <paragraph num="(d)"> <text>Other pertinent material.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant intends to enter into subcontracts for transportation services referred to in §B(2) of this regulation, the applicant shall provide the following information:</text> <paragraph num="(1)"> <text>The names of the subcontractors;</text> </paragraph> <paragraph num="(2)"> <text>The scope of services to be subcontracted;</text> </paragraph> <paragraph num="(3)"> <text>The payment arrangement and payment level; and</text> </paragraph> <paragraph num="(4)"> <text>The plan for monitoring the performance of the subcontractors.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Services to Recipients."> <paragraph num="A."> <text>A grantee is responsible for arranging or providing nonemergency transportation to and from medically necessary covered services to Medical Assistance recipients and, when necessary, their attendants, who have no other means of transportation available. In carrying out this duty, a grantee:</text> <paragraph num="(1)"> <text>Shall screen recipients' requests for transportation in order to identify whether transportation is available to the recipients from other sources;</text> </paragraph> <paragraph num="(2)"> <text>When determining the appropriate means of transport for a recipient who appears to have a mental or physical disability which would prevent the recipient from using public transportation, shall request documentation prepared by the recipient's physician which indicates that the recipient's medical condition makes it medically contraindicated for the recipient to use public transportation;</text> </paragraph> <paragraph num="(3)"> <text>Shall refer recipients to organizations and programs which might be able to provide transportation and otherwise arrange for transportation when appropriate;</text> </paragraph> <paragraph num="(4)"> <text>Shall encourage the development and expansion of transportation resources such as churches and other community organizations;</text> </paragraph> <paragraph num="(5)"> <text>Shall provide transportation to recipients for whom there is no other transportation resource available, in the most efficient and cost-effective manner possible, including the use of volunteers and charitable organizations whenever possible; and</text> </paragraph> <paragraph num="(6)"> <text>May refuse to pay for transportation services if the recipient requests transportation less than 24 hours before the time the transportation is to be provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening referred to in §A(1) of this regulation includes obtaining the information listed below, as appropriate:</text> <paragraph num="(1)"> <text>Whether a recipient or a member of the recipient's household owns a vehicle;</text> </paragraph> <paragraph num="(2)"> <text>Availability of vehicles owned by friends or relatives with whom a recipient does not share a household;</text> </paragraph> <paragraph num="(3)"> <text>Availability of a volunteer using a privately owned vehicle;</text> </paragraph> <paragraph num="(4)"> <text>Availability of a volunteer from a public or private agency;</text> </paragraph> <paragraph num="(5)"> <text>Availability of transportation services provided for free by any other city, county, or State agency programs;</text> </paragraph> <paragraph num="(6)"> <text>Methods by which a recipient previously reached medical services or currently reaches nonmedical services, such as the grocery store;</text> </paragraph> <paragraph num="(7)"> <text>Whether a recipient can walk to the medical service;</text> </paragraph> <paragraph num="(8)"> <text>Whether public bus transportation operates between a recipient's home and medical service;</text> </paragraph> <paragraph num="(9)"> <text>Whether a recipient is mentally or physically disabled;</text> </paragraph> <paragraph num="(10)"> <text>Whether a recipient is chronically ill or otherwise requires medical services on a frequent and ongoing basis; and</text> </paragraph> <paragraph num="(11)"> <text>Whether a recipient can reschedule an appointment to a time when transportation would be available.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When the recipient is unable without assistance to obtain the documentation referred to in §A(2) of this regulation, and has no family member or other representative who can provide assistance, the grantee shall offer to contact the recipient's health care provider to request documentation of disability.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Monies from a grant provided under these regulations may not be used to pay for the following:</text> <paragraph num="A."> <text>Emergency transportation services;</text> </paragraph> <paragraph num="B."> <text>Medicare ambulance services;</text> </paragraph> <paragraph num="C."> <text>Transportation to or from Veterans Administration hospitals unless it is to receive treatment for a non-military-related condition;</text> </paragraph> <paragraph num="D."> <text>Transportation to or from any correctional institutions;</text> </paragraph> <paragraph num="E."> <text>Transportation of recipients committed by the courts to mental institutions;</text> </paragraph> <paragraph num="F."> <text>Transportation between a nursing facility and a hospital, for routine diagnostic tests, nursing services, or physical therapy which can be performed at the nursing facility;</text> </paragraph> <paragraph num="G."> <text>Transportation services from a facility for treatment when the treatment is provided by the facility in which the recipient is located;</text> </paragraph> <paragraph num="H."> <text>Transportation to receive nonmedical services;</text> </paragraph> <paragraph num="I."> <text>Gratuities of any kind;</text> </paragraph> <paragraph num="J."> <text>Transportation between a medical day care facility and the recipient's home;</text> </paragraph> <paragraph num="K."> <text>Transportation to or from a State facility while the patient is a resident of that facility;</text> </paragraph> <paragraph num="L."> <text>Transportation of non-Medical Assistance recipients;</text> </paragraph> <paragraph num="M."> <text>Trips for purposes related to education, recreational activities, or employment;</text> </paragraph> <paragraph num="N."> <text>Transportation of anyone other than the recipient, except for an attendant accompanying a minor or when an attendant is medically necessary;</text> </paragraph> <paragraph num="O."> <text>Wheelchair van service for ambulatory recipients;</text> </paragraph> <paragraph num="P."> <text>Ambulance service for a recipient who does not need to be transported in a prone position;</text> </paragraph> <paragraph num="Q."> <text>Transportation between a community rehabilitation program (CRP) and the recipient's home;</text> </paragraph> <paragraph num="R."> <text>Transportation between a day habilitation program and the recipient's home;</text> </paragraph> <paragraph num="S."> <text>Transportation to or from services that are not medically necessary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Notices to Recipients."> <text>Whenever a grantee determines that the grantee will not arrange or provide transportation for a recipient who has requested transportation at least 24 hours in advance, even though the recipient has no available transportation resource, the grantee shall send the recipient a notice on a form, approved by the Department, that states the recipient has a right to a fair hearing pursuant to COMAR 10.09.24.13.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Documentation."> <text>A grantee shall document the following items and make the documentation available to the Department upon request:</text> <paragraph num="A."> <text>Whether the recipient had other transportation available or could reschedule the appointment to a time when transportation would be available;</text> </paragraph> <paragraph num="B."> <text>That any transportation paid for out of grant funds was to or from a medically necessary service for a recipient; and</text> </paragraph> <paragraph num="C."> <text>Which recipients the grantee denied transportation and the reason or reasons why.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Accountability."> <text>The Department shall:</text> <paragraph num="A."> <text>Follow all applicable policies required by COMAR 10.04.04 when approving grants; and</text> </paragraph> <paragraph num="B."> <text>Reconcile each grant on a yearly basis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Responsibility to Recipients."> <text>A grantee is expected to meet the transportation needs of recipients in a grantee's county out of grant funds. In those circumstances when the grant funds are insufficient, the grantee shall contact the Program's staff specialist for transportation services, who shall evaluate and assist in resolving transportation requests. A grantee may not refuse services or assistance to a recipient who requests transportation on the basis that the grantee's grant funds have been exhausted.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>These regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 26, 1981 (8:13 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed effective July 1, 1987 (14:4 Md. R. 418)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted effective July 1, 1987 (14:4 Md. R. 418)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .05A amended, and .04G adopted as an emergency provision effective May 1, 1991 (18:7 Md. R. 765); amended permanently effective October 1, 1991 (18:15 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A—C amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A and B amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C and D amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12, General Transportation, repealed effective May 24, 1993 (20:10 Md. R. 851)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10, Transportation Grants, adopted effective May 24, 1993 (20:10 Md. R. 851)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 1, 1994 (21:12 Md. R. 1060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 1994 (21:12 Md. R. 1060)</annotation> </annotations> </chapter> <chapter num="20" heading="Community Personal Assistance Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Bathing and completing personal hygiene routines;</text> </paragraph> <paragraph num="(b)"> <text>Dressing and changing clothes;</text> </paragraph> <paragraph num="(c)"> <text>Eating;</text> </paragraph> <paragraph num="(d)"> <text>Mobility, including:</text> <paragraph num="(i)"> <text>Transferring from a bed, chair, or other structure;</text> </paragraph> <paragraph num="(ii)"> <text>Moving, turning, and positioning the body while in bed or in a wheelchair; and</text> </paragraph> <paragraph num="(iii)"> <text>Moving about indoors or outdoors; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Toileting, including:</text> <paragraph num="(i)"> <text>Bladder and bowel requirements;</text> </paragraph> <paragraph num="(ii)"> <text>Routines associated with the achievement or maintenance of continence; and</text> </paragraph> <paragraph num="(iii)"> <text>Incontinence care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who is applying to receive services under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Assistance” means that another individual:</text> <paragraph num="(a)"> <text>Physically performs the activity for the participant;</text> </paragraph> <paragraph num="(b)"> <text>Physically helps the participant to perform the activity;</text> </paragraph> <paragraph num="(c)"> <text>Monitors the participant’s performance of the activity in order to ensure health and safety; or</text> </paragraph> <paragraph num="(d)"> <text>Cues or encourages the participant to perform the activity.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Certified medication technician (CMT)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Completes a course in medication administration approved by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and</text> </paragraph> <paragraph num="(c)"> <text>Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and</text> </paragraph> <paragraph num="(b)"> <text>Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Community Setting.</text> <paragraph num="(a)"> <text>“Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to:</text> <paragraph num="(i)"> <text>Seek employment and work in competitive integrated settings;</text> </paragraph> <paragraph num="(ii)"> <text>Engage in community life;</text> </paragraph> <paragraph num="(iii)"> <text>Control personal resources; and</text> </paragraph> <paragraph num="(iv)"> <text>Receive services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Community setting” does not mean:</text> <paragraph num="(i)"> <text>Hospitals;</text> </paragraph> <paragraph num="(ii)"> <text>Nursing facilities;</text> </paragraph> <paragraph num="(iii)"> <text>Institutions for mental diseases;</text> </paragraph> <paragraph num="(iv)"> <text>Intermediate care facilities for individuals with intellectual disabilities; or</text> </paragraph> <paragraph num="(v)"> <text>Other institutions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties.</text> </paragraph> <paragraph num="(8)"> <text>“Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a:</text> <paragraph num="(a)"> <text>Registered nurse in accordance with COMAR 10.27.11; or</text> </paragraph> <paragraph num="(b)"> <text>Nurse practitioner in accordance with COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health or its authorized agent acting on behalf of the Department.</text> </paragraph> <paragraph num="(10)"> <text>Home.</text> <paragraph num="(a)"> <text>“Home” means the participant’s place of residence in a community setting.</text> </paragraph> <paragraph num="(b)"> <text>“Home” does not mean:</text> <paragraph num="(i)"> <text>An assisted living program as defined in COMAR 10.07.14;</text> </paragraph> <paragraph num="(ii)"> <text>A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07;</text> </paragraph> <paragraph num="(iii)"> <text>An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01;</text> </paragraph> <paragraph num="(iv)"> <text>Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or</text> </paragraph> <paragraph num="(v)"> <text>Any other provider-owned or controlled residence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor.</text> </paragraph> <paragraph num="(12)"> <text>“Instrumental activities of daily living” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Preparing meals;</text> </paragraph> <paragraph num="(b)"> <text>Performing light chores that are incidental to the personal assistance services provided to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries;</text> </paragraph> <paragraph num="(d)"> <text>Nutritional planning;</text> </paragraph> <paragraph num="(e)"> <text>Traveling as needed;</text> </paragraph> <paragraph num="(f)"> <text>Managing finances and handling money;</text> </paragraph> <paragraph num="(g)"> <text>Using the telephone or other appropriate means of communication;</text> </paragraph> <paragraph num="(h)"> <text>Reading; and</text> </paragraph> <paragraph num="(i)"> <text>Planning and making decisions.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants.</text> </paragraph> <paragraph num="(14)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01.</text> </paragraph> <paragraph num="(16)"> <text>“Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care.</text> </paragraph> <paragraph num="(17)"> <text>“Participant” means an individual who:</text> <paragraph num="(a)"> <text>Has been determined to meet the qualifications for participation in Community Personal Assistance Services as specified in Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled with the Department to receive Medicaid services.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Personal assistance provider agency” means a public or private agency that:</text> <paragraph num="(a)"> <text>Employs or contracts with personal assistance workers; and</text> </paragraph> <paragraph num="(b)"> <text>Has been enrolled by the Program as a provider of personal assistance services.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Personal Assistance Services.</text> <paragraph num="(a)"> <text>“Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability.</text> </paragraph> <paragraph num="(b)"> <text>“Personal assistance services” includes:</text> <paragraph num="(i)"> <text>Assistance with activities of daily living and instrumental activities of daily living; and</text> </paragraph> <paragraph num="(ii)"> <text>The performance of delegated nursing functions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Plan of service” means the support plan that:</text> <paragraph num="(a)"> <text>Reflects what is important to the individual and what is important for the individual’s welfare; and</text> </paragraph> <paragraph num="(b)"> <text>Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Preauthorized” means approved by the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(22)"> <text>“Program” means the Maryland Medicaid Program.</text> </paragraph> <paragraph num="(23)"> <text>“Provider” has the same meaning as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(24)"> <text>“Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter.</text> </paragraph> <paragraph num="(25)"> <text>“Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant.</text> </paragraph> <paragraph num="(26)"> <text>“Representative” means:</text> <paragraph num="(a)"> <text>The person authorized by the individual to serve as a representative in connection with the provision of personal assistance services and supports;</text> </paragraph> <paragraph num="(b)"> <text>The individual who signs the plan of service on the participant’s behalf;</text> </paragraph> <paragraph num="(c)"> <text>Any individual who makes decisions on behalf of the participant related to the participant’s plan of service;</text> </paragraph> <paragraph num="(d)"> <text>A legal guardian of the individual for the participant; or</text> </paragraph> <paragraph num="(e)"> <text>The parent or foster parent of a dependent minor child.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Supports planner” means an individual who coordinates services, including:</text> <paragraph num="(a)"> <text>Supporting development of a plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and</text> </paragraph> <paragraph num="(c)"> <text>Ensuring an accurate plan of service is provided to the Department.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Telephonic time-keeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant.</text> </paragraph> <paragraph num="(29)"> <text>“Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Provider Licensing or Certification."> <text>The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered:</text> <paragraph num="A."> <text>Registered nurses;</text> </paragraph> <paragraph num="B."> <text>Licensed practical nurses;</text> </paragraph> <paragraph num="C."> <text>Certified medication technicians; and</text> </paragraph> <paragraph num="D."> <text>Certified nursing assistants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>To participate in the Program, the participant shall:</text> <paragraph num="(1)"> <text>Be determined by the Department to need assistance with one or more activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Be eligible for Medicaid under an eligibility coverage group described in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and</text> </paragraph> <paragraph num="(3)"> <text>Reside at home.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To be eligible for participation, a participant shall have an active plan of service. The plan of service shall:</text> <paragraph num="(1)"> <text>Be based on:</text> <paragraph num="(a)"> <text>The evaluation and recommended plan of care; and</text> </paragraph> <paragraph num="(b)"> <text>Consultation with the applicant or participant;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Address the applicant’s or participant’s health and safety needs;</text> </paragraph> <paragraph num="(3)"> <text>Specify the services needed to safely support the participant in the community, including a plan for receiving personal assistance services in case of an emergency;</text> </paragraph> <paragraph num="(4)"> <text>Specify the provider agency providing personal assistance services; and</text> </paragraph> <paragraph num="(5)"> <text>Include the signature of the:</text> <paragraph num="(a)"> <text>Participant or, when applicable, the individual’s representative;</text> </paragraph> <paragraph num="(b)"> <text>Supports planner; and</text> </paragraph> <paragraph num="(c)"> <text>Personal assistance provider agency listed within the plan of service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs.</text> </paragraph> <paragraph num="D."> <text>Participant eligibility shall be terminated if the participant:</text> <paragraph num="(1)"> <text>No longer meets the required level of care;</text> </paragraph> <paragraph num="(2)"> <text>No longer resides at home;</text> </paragraph> <paragraph num="(3)"> <text>Is without personal assistance services for 30 consecutive calendar days;</text> </paragraph> <paragraph num="(4)"> <text>Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program;</text> </paragraph> <paragraph num="(5)"> <text>Moves to another state;</text> </paragraph> <paragraph num="(6)"> <text>Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or</text> </paragraph> <paragraph num="(7)"> <text>Dies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Provider Participation — General Requirements."> <paragraph num="A."> <text>To participate as a provider of a service covered under this chapter, a provider:</text> <paragraph num="(1)"> <text>Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall verify the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request;</text> </paragraph> <paragraph num="(3)"> <text>Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by:</text> <paragraph num="(a)"> <text>Reporting incidents and complaints within 24 hours of knowledge of the event;</text> </paragraph> <paragraph num="(b)"> <text>Submitting a written report within 7 calendar days on a form designated by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents;</text> </paragraph> <paragraph num="(5)"> <text>Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been:</text> <paragraph num="(a)"> <text>Preauthorized in the participant’s plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Provided in a manner consistent with the participant’s plan of service; and</text> </paragraph> <paragraph num="(c)"> <text>Identified in the provider agreement as within the scope of the provider’s Medicaid participation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative;</text> </paragraph> <paragraph num="(8)"> <text>Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services;</text> </paragraph> <paragraph num="(9)"> <text>Shall verify Medicaid eligibility at the beginning of each month that services will be rendered;</text> </paragraph> <paragraph num="(10)"> <text>May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and</text> </paragraph> <paragraph num="(11)"> <text>Shall be free from conflicts of interest.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have:</text> <paragraph num="(1)"> <text>Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker;</text> </paragraph> <paragraph num="(2)"> <text>Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.84;</text> </paragraph> <paragraph num="(3)"> <text>Undergone the imposition of sanctions under COMAR 10.09.36.08;</text> </paragraph> <paragraph num="(4)"> <text>Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency;</text> </paragraph> <paragraph num="(5)"> <text>Been cited by a State agency for deficiencies which affect participants’ health and safety; or</text> </paragraph> <paragraph num="(6)"> <text>Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to:</text> <paragraph num="(a)"> <text>Failure to meet contractual obligations; or</text> </paragraph> <paragraph num="(b)"> <text>Fraudulent billing practices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider who renders health-related services to participants shall agree to:</text> <paragraph num="(1)"> <text>Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Share and discuss the documented information at the request of the participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Specific Conditions for Provider Participation — Personal Assistance."> <paragraph num="A."> <text>Personal assistance service providers shall:</text> <paragraph num="(1)"> <text>Be licensed as a residential service agency under COMAR 10.07.05 to provide Level Two or Level Three home care services;</text> </paragraph> <paragraph num="(2)"> <text>Employ a registered nurse who shall:</text> <paragraph num="(a)"> <text>Assess each new participant who requires personal assistance services;</text> </paragraph> <paragraph num="(b)"> <text>Participate in developing the worker instructions and in assigning appropriate personnel;</text> </paragraph> <paragraph num="(c)"> <text>Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and</text> </paragraph> <paragraph num="(d)"> <text>Participate in instructing the workers who will provide the assistance, when indicated;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following:</text> <paragraph num="(a)"> <text>The participant or, when applicable, the participant’s representative;</text> </paragraph> <paragraph num="(b)"> <text>The nurse monitor;</text> </paragraph> <paragraph num="(c)"> <text>A treating physician or nurse practitioner; or</text> </paragraph> <paragraph num="(d)"> <text>An individual from the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide services directly through their workers under the direction of the participant or, when applicable, the participant’s representative;</text> </paragraph> <paragraph num="(5)"> <text>Allow participants to have a significant role in the delivery of their specific care including:</text> <paragraph num="(a)"> <text>Directing the services and supports identified in their plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Exercising as much control as desired to select, train, schedule, determine duties of, and dismiss the personal assistance worker in their home;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Notify the Department in writing at least 45 days in advance of any:</text> <paragraph num="(a)"> <text>Voluntary closure;</text> </paragraph> <paragraph num="(b)"> <text>Change of ownership;</text> </paragraph> <paragraph num="(c)"> <text>Change of location;</text> </paragraph> <paragraph num="(d)"> <text>Sale of the business;</text> </paragraph> <paragraph num="(e)"> <text>Change in the name under which the provider is doing business; or</text> </paragraph> <paragraph num="(f)"> <text>Change in provider tax identification number;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business;</text> </paragraph> <paragraph num="(8)"> <text>Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants;</text> </paragraph> <paragraph num="(9)"> <text>If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services;</text> </paragraph> <paragraph num="(10)"> <text>Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program; and</text> </paragraph> <paragraph num="(11)"> <text>Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall:</text> <paragraph num="(1)"> <text>If required to administer medications in accordance with the plan of service, be a certified medications technician; and</text> </paragraph> <paragraph num="(2)"> <text>If performing other delegated nursing functions, also be a certified nursing assistant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A personal assistance provider agency may not assign the participant’s representative to provide services to that participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for Provider Participation — Supports Planning."> <text>To participate in the Program as a supports planning provider under Regulation .10 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Agree to be monitored by the Department; and</text> </paragraph> <paragraph num="B."> <text>Be:</text> <paragraph num="(1)"> <text>Identified by the Department through a solicitation process; or</text> </paragraph> <paragraph num="(2)"> <text>The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for Provider Participation — Nurse Monitoring."> <text>To participate in the Program as a nurse monitoring provider under Regulation .11 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act;</text> </paragraph> <paragraph num="B."> <text>Employ or contract with registered nurses who hold a current professional license to practice in Maryland;</text> </paragraph> <paragraph num="C."> <text>Agree to accept all referrals from the Department; and</text> </paragraph> <paragraph num="D."> <text>Agree to be monitored by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Covered Services — General."> <text>The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .14 of this chapter, and documented as necessary to prevent institutionalization.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services — Personal Assistance."> <paragraph num="A."> <text>The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="B."> <text>The Program covers the following services when provided by a personal assistance provider:</text> <paragraph num="(1)"> <text>Assistance with activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Delegated nursing functions if this assistance is:</text> <paragraph num="(a)"> <text>Specified in the participant’s plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assistance with tasks requiring judgment to protect a participant from harm or neglect;</text> </paragraph> <paragraph num="(4)"> <text>Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Personal assistance services may not include:</text> <paragraph num="(1)"> <text>Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant;</text> </paragraph> <paragraph num="(2)"> <text>The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or</text> </paragraph> <paragraph num="(3)"> <text>Housekeeping services, other than those incidental to services covered under §B of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Covered Services — Supports Planning."> <paragraph num="A."> <text>Supports planning services shall:</text> <paragraph num="(1)"> <text>Address the individualized needs of the participant;</text> </paragraph> <paragraph num="(2)"> <text>Be sensitive to the educational background, culture, and general environment of the participant;</text> </paragraph> <paragraph num="(3)"> <text>Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties of, and dismiss the personal assistance provider; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure freedom of choice among any willing provider for all services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supports planning services include the following activities:</text> <paragraph num="(1)"> <text>Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant;</text> </paragraph> <paragraph num="(2)"> <text>Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to:</text> <paragraph num="(a)"> <text>Behavioral health;</text> </paragraph> <paragraph num="(b)"> <text>Educational services;</text> </paragraph> <paragraph num="(c)"> <text>Disposable medical supplies and durable medical equipment;</text> </paragraph> <paragraph num="(d)"> <text>Housing;</text> </paragraph> <paragraph num="(e)"> <text>Medical services; and</text> </paragraph> <paragraph num="(f)"> <text>Social services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitoring the provision of services to determine if services are received in accordance with the plan of service;</text> </paragraph> <paragraph num="(4)"> <text>Using information technology systems developed by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Coordinating with the fiscal intermediary to assist in managing budgeted resources;</text> </paragraph> <paragraph num="(6)"> <text>Providing guidance and support to help individuals self-direct their services; and</text> </paragraph> <paragraph num="(7)"> <text>Administering funds for transition services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Services — Nurse Monitoring."> <paragraph num="A."> <text>The Program covers the following services when provided by a nurse monitor:</text> <paragraph num="(1)"> <text>Being available to give instruction and to answer questions;</text> </paragraph> <paragraph num="(2)"> <text>Complying with the Department’s reportable events policy; and</text> </paragraph> <paragraph num="(3)"> <text>Maintaining an up-to-date client profile in an electronic database designated by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers nurse monitoring services according to the following schedule:</text> <paragraph num="(1)"> <text>Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and</text> </paragraph> <paragraph num="(2)"> <text>Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Home and Workplace Visits.</text> <paragraph num="(1)"> <text>The nurse monitoring provider shall use the home or workplace visit for the following purposes:</text> <paragraph num="(a)"> <text>To assess the participant’s condition;</text> </paragraph> <paragraph num="(b)"> <text>To assess the quality of personal assistance services; and</text> </paragraph> <paragraph num="(c)"> <text>To determine the need for discharge from personal assistance services or referral to other services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nurse monitor shall assess the quality of personal assistance services by:</text> <paragraph num="(a)"> <text>Reviewing documentation related to the provision of personal assistance services; and</text> </paragraph> <paragraph num="(b)"> <text>Observing the performance of the worker, as appropriate.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Conditions for Reimbursement."> <text>The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, if provided in accordance with the requirements of this chapter, and if the service:</text> <paragraph num="A."> <text>Is recommended on the participant’s plan of service as necessary to assure the health and safety of an applicant or participant in the community;</text> </paragraph> <paragraph num="B."> <text>Has been preauthorized by the Department in the participant’s plan of service;</text> </paragraph> <paragraph num="C."> <text>Is provided to an enrolled participant;</text> </paragraph> <paragraph num="D."> <text>Is medically necessary; and</text> </paragraph> <paragraph num="E."> <text>Is provided by a Medicaid provider who meets the conditions for participation under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Limitations."> <paragraph num="A."> <text>The Department shall establish a budget for personal assistance services that may be included in the participant’s plan of service, based on each participant’s assessed need.</text> </paragraph> <paragraph num="B."> <text>The Program does not cover the following services:</text> <paragraph num="(1)"> <text>Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as:</text> <paragraph num="(a)"> <text>Cleaning of the floor and furniture in areas not occupied by the participant;</text> </paragraph> <paragraph num="(b)"> <text>Laundry other than that incidental to the care of the participant; and</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries or household items unless in the company of the participant;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meals delivered to the home;</text> </paragraph> <paragraph num="(3)"> <text>Services provided by providers not approved for participation by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Expenses incurred while escorting participants:</text> <paragraph num="(a)"> <text>To obtain medical diagnosis or treatment;</text> </paragraph> <paragraph num="(b)"> <text>To or from the participant’s workplace; or</text> </paragraph> <paragraph num="(c)"> <text>For participation in social or community activities;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Expenses related to room and board for either the participant or the worker; or</text> </paragraph> <paragraph num="(6)"> <text>Personal assistance services provided outside the State for more than 30 days per calendar year.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for:</text> <paragraph num="(1)"> <text>Administrative overhead;</text> </paragraph> <paragraph num="(2)"> <text>Travel;</text> </paragraph> <paragraph num="(3)"> <text>Internal quality monitoring activities;</text> </paragraph> <paragraph num="(4)"> <text>Staff supervision, training, or consultation; or</text> </paragraph> <paragraph num="(5)"> <text>Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless pre-authorized by the Department in writing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .09 of this chapter, a provider and its workers shall use the telephonic time-keeping system approved by the Department to:</text> <paragraph num="(1)"> <text>Document time; and</text> </paragraph> <paragraph num="(2)"> <text>Submit claims.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .10 and .11 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual.</text> </paragraph> <paragraph num="C."> <text>Billing time limitations are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments for services rendered to a participant shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established according to the fee schedule published by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Effective July 1, 2018, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid.</text> </paragraph> <paragraph num="F."> <text>Rates.</text> <paragraph num="(1)"> <text>The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2018, the Program’s rates as specified in the Department’s fee schedule shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement procedures shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Appeal Procedures — Providers."> <text>Appeal procedures shall be as set forth in:</text> <paragraph num="A."> <text>COMAR 10.09.36.09; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Appeal Procedures — Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in:</text> <paragraph num="A."> <text>COMAR 10.09.24.13; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Interpretive Regulation."> <text>Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Implementation Date."> <text>This chapter shall be implemented October 1, 2015.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 27, 1980 (7:13 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F-1—F-3 and .06E adopted, and Regulations .05B; .06B, D; and .07B, B-1, C amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); emergency status expired November 30, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F-1—F-3 adopted effective December 1, 1986 (13:21 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F-4—F-6 adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01I-1 and J-1 adopted effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A and B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03A, B, .05, .07C amended as an emergency provision effective July 1, 1983 (10:13 Md. R. 1177); adopted permanently effective October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A-1 adopted effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A-2 adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B-1 adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04 and .05B, D amended effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 22, 1984 (11:21 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, E, F adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 1, 1986 (13:21 Md. R. 2321); July 17, 1995 (22:14 Md. R. 1053)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B and D amended, and E adopted effective December 1, 1986 (13:21 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584); April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective August 30, 1982 (9:17 Md. R. 1708); May 1, 1983 (10:8 Md. R. 726); December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B-1 adopted effective April 6, 1986 (13:7 Md. R. 795); amended effective December 1, 1986 (13:21 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B-2 adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1172); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D adopted effective July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective December 28, 1998 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365)</annotation> <annotation type="History" subtype="Administrative History">Regulations .09A, C, D and .10A amended effective April 6, 1986 (13:7 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 20, 1989 (16:3 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); adopted permanently effective December 1, 1991 (18:23 Md. R. 2488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03, .05, and .07 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); emergency status expired December 31, 1998</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03, .05, and .07 amended effective September 6, 1999 (26:18 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 14, 2011 (38:23 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 22, 2010 (37:6 Md. R. 477)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 22, 2010 (37:6 Md. R. 477)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 31, 2005 (32:2 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective November 14, 2011 (38:23 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E, F repealed effective August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 31, 2005 (32:2 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, F amended effective November 14, 2011 (38:23 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective November 14, 2011 (38:23 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2008 (35:16 Md. R. 1389); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 24, 2012 (39:25 Md. R. 1612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective May 4, 2009 (36:9 Md. R. 651); December 13, 2010 (37:25 Md. R. 1738)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11, Personal Care Services, repealed and new Regulations .01—.20, Community Personal Assistance Services, adopted effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486)</annotation> </annotations> </chapter> <chapter num="21" heading="Pharmacists"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter establishes requirements for individual pharmacists who enroll in the Program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals.</text> </paragraph> <paragraph num="(3)"> <text>“Medication therapy management” services are defined as face-to-face consultations that are structured to reduce the risk of adverse events and ensure optimum therapeutic outcomes for targeted patients through improved medication use with disease-state specific education, counseling, and medication review related to treatments, including drug therapy, laboratory tests, or medical devices provided by licensed and practicing pharmacists.</text> </paragraph> <paragraph num="(4)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(5)"> <text>“Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided.</text> </paragraph> <paragraph num="(6)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Provider Qualifications and Conditions for Participation."> <text>The pharmacist shall meet:</text> <paragraph num="A."> <text>Licensure requirements set forth in COMAR 10.09.36.02;</text> </paragraph> <paragraph num="B."> <text>Conditions for participation set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="C."> <text>Conditions for their license under the Board of Pharmacy as stated in Health Occupations Article, Title 12, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following medically necessary services when rendered by a pharmacist:</text> <paragraph num="A."> <text>Services rendered within the pharmacist’s lawful scope of practice as defined by the Board and otherwise covered by the Program in accordance with COMAR 10.09.02.07D; and</text> </paragraph> <paragraph num="B."> <text>Medication therapy management for participants who meet the Department’s clinical criteria.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The following are not covered:</text> <paragraph num="A."> <text>Pharmacist administered drugs obtained from manufacturers who do not participate in the federal Drug Rebate Program;</text> </paragraph> <paragraph num="B."> <text>Medical supplies usually included in an office visit;</text> </paragraph> <paragraph num="C."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="D."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="E."> <text>Procedures solely for cosmetic purposes; and</text> </paragraph> <paragraph num="F."> <text>Services denied by Medicare as not medically justified.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall adhere to general provider payment procedures established in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>The provider shall be reimbursed in accordance with COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="C."> <text>Effective January 1, 2024, medication therapy management shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>For the first 8—15 minutes:</text> <paragraph num="(a)"> <text>For new patients, $49.67 per unit of service; or</text> </paragraph> <paragraph num="(b)"> <text>For established patients, $31.24 per unit of service; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For each additional 8—15 minute, $24.54 per unit of service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-148(c), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 31, 2018 (45:26 Md. R. 1242)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 6, 2025 (51:26 Md. R. 1187)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, D adopted effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 6, 2025 (51:26 Md. R. 1187)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473); May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187)</annotation> </annotations> </chapter> <chapter num="22" heading="Free-Standing Dialysis Facility Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“CMS” means Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(2)"> <text>“Continuous ambulatory peritoneal dialysis (CAPD)” means a dialysis treatment method performed manually during the day by patient in which the patient’s peritoneal membrane is used as a dialyzer.</text> </paragraph> <paragraph num="(3)"> <text>“Continuous cycling peritoneal dialysis (CCPD)” means a dialysis treatment method performed automatically during the night with a peritoneal dialysis cycler in which the patient’s peritoneal membrane is used as a dialyzer.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Dialysis” means a treatment method in which waste products are removed from the body by diffusion from one fluid compartment to another across a semi-permeable membrane.</text> </paragraph> <paragraph num="(6)"> <text>“Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Board of Dietetic Practice to practice dietetics in Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Free-standing dialysis facility” means a dialysis unit capable of providing staff-assisted dialysis, which is not located in an acute hospital setting.</text> </paragraph> <paragraph num="(8)"> <text>“Hemodialysis” means a dialysis treatment method in which blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient’s body.</text> </paragraph> <paragraph num="(9)"> <text>“Home dialysis” means hemodialysis or peritoneal dialysis performed regularly in the home with the assistance of a family member or the patient’s caregiver.</text> </paragraph> <paragraph num="(10)"> <text>"Home dialysis training” means instructions on how to perform dialysis services in a home setting.</text> </paragraph> <paragraph num="(11)"> <text>“Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(13)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family or provider.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(15)"> <text>“Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(17)"> <text>“Patient care policies” means written policies and protocols describing patient care practices and procedures established by a group of professional personnel (including one or more physicians affiliated with the free-standing dialysis facility) and approved in writing by the facility's medical director.</text> </paragraph> <paragraph num="(18)"> <text>“Peritoneal dialysis” means a dialysis treatment method in which waste products pass from the patient’s body through the peritoneal membrane into the peritoneal cavity where the bath solution (dialysate) is introduced and removed periodically.</text> </paragraph> <paragraph num="(19)"> <text>“Physician” means an individual who is authorized under the Maryland Medical Practice Act to practice medicine in this State as stated in Health-General Article §1-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Plan of care” means a written plan for evaluation, treatment, and follow-up of each participant documented in the participant’s medical record that should include, at a minimum, the following information:</text> <paragraph num="(a)"> <text>Patient identification data;</text> </paragraph> <paragraph num="(b)"> <text>Date of service;</text> </paragraph> <paragraph num="(c)"> <text>Reason for visit;</text> </paragraph> <paragraph num="(d)"> <text>Medical history;</text> </paragraph> <paragraph num="(e)"> <text>Plan for treatment;</text> </paragraph> <paragraph num="(f)"> <text>Results of all laboratory tests ordered and performed; and</text> </paragraph> <paragraph num="(g)"> <text>Interpretation of all diagnostic radiology procedures ordered and performed.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(23)"> <text>“Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Social worker” means a person who is licensed as a social worker in accordance with COMAR 10.42.01.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A physician providing services in a free-standing dialysis facility shall be licensed and legally authorized to practice medicine in the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02, or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="D."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or COMAR 10.10.06, as applicable; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a free-standing dialysis facility include all of the following:</text> <paragraph num="(1)"> <text>Be approved by Medicare to furnish dialysis service to kidney disease patients and maintain documentation of certification by the Division of Survey and Certification of CMS.</text> </paragraph> <paragraph num="(2)"> <text>Verify the licenses and credentials of all professionals employed by, or under contract with, the free-standing dialysis facility to provide services.</text> </paragraph> <paragraph num="(3)"> <text>Meet the requirements of COMAR 10.30.01.05C, for a dialysis facility, home dialysis unit, or self-care dialysis facility, or all of the above.</text> </paragraph> <paragraph num="(4)"> <text>Have clearly defined, written, patient care policies.</text> </paragraph> <paragraph num="(5)"> <text>Maintain adequate documentation of each participant visit, as part of the plan of care, which, at a minimum, shall include:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant’s reason for visit;</text> </paragraph> <paragraph num="(c)"> <text>A brief description of service provided;</text> </paragraph> <paragraph num="(d)"> <text>A legible signature and printed or typed name of professional providing care, with the appropriate title.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01.</text> </paragraph> <paragraph num="(7)"> <text>Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the free-standing dialysis facility services are provided in accordance with this regulation.</text> </paragraph> <paragraph num="(8)"> <text>Not employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Medical Assistance participants.</text> </paragraph> <paragraph num="(9)"> <text>Be approved by the Medical Assistance Program in the state in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers medically necessary services described in §B of this regulation, rendered to participants in a free-standing dialysis facility, when these services are:</text> <paragraph num="(1)"> <text>Performed by a physician or by one of the following:</text> <paragraph num="(a)"> <text>A physician assistant;</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner;</text> </paragraph> <paragraph num="(c)"> <text>An RN;</text> </paragraph> <paragraph num="(d)"> <text>An LPN;</text> </paragraph> <paragraph num="(e)"> <text>A social worker; or</text> </paragraph> <paragraph num="(f)"> <text>A dietitian-nutritionist;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provided by a non-physician listed in §A(1) of this regulation, when the following conditions are met:</text> <paragraph num="(a)"> <text>The individual performing the service is in the employ of, or under contract with, the free-standing dialysis facility;</text> </paragraph> <paragraph num="(b)"> <text>The individual performing the service is under a physician's direct supervision or written direction;</text> </paragraph> <paragraph num="(c)"> <text>The individual performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of the physician's services; and</text> </paragraph> <paragraph num="(d)"> <text>The services are provided according to the free-standing dialysis facility physician's written plan of care;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Curative or rehabilitative services, when clearly related to the participant’s individual needs;</text> </paragraph> <paragraph num="(4)"> <text>Adequately described in the participant’s medical record and consistent with the physician’s written plan of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Covered services include:</text> <paragraph num="(1)"> <text>Dialysis services furnished on an outpatient basis and provided by a free-standing dialysis facility, to include hemodialysis, peritoneal dialysis, CAPD, CCPD, and home dialysis training; and</text> </paragraph> <paragraph num="(2)"> <text>Laboratory tests, supplies, and prescription drugs as related to dialysis services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>Drugs and supplies which are acquired at no cost;</text> </paragraph> <paragraph num="E."> <text>Injections and visits solely for the administration of injections, unless both the participant’s inability to take oral medications and medical necessity for the injections are documented in the participant’s medical record;</text> </paragraph> <paragraph num="F."> <text>Travel expenses;</text> </paragraph> <paragraph num="G."> <text>Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service;</text> </paragraph> <paragraph num="H."> <text>Laboratory or X-ray services performed by another facility;</text> </paragraph> <paragraph num="I."> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="J."> <text>Broken or missed appointments; and</text> </paragraph> <paragraph num="K."> <text>Professional services rendered by mail or telephone.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>Reimbursement by the Program is for services described in Regulation .04B of this chapter provided at a free-standing dialysis facility which has been approved for Medicare by the Division of Survey and Certification of CMS.</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement shall be consistent with the rates established by the Program for those services which are approved by Medicare.</text> </paragraph> <paragraph num="(3)"> <text>Physician services are not reimbursed under this regulation. Reimbursement for physician services are in accordance with COMAR 10.09.02.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall submit a request for payment on the form designated by the Department.</text> </paragraph> <paragraph num="C."> <text>The Program reserves the right to return to the provider, any invoice that is not properly completed.</text> </paragraph> <paragraph num="D."> <text>A provider shall bill the program the established Medicaid rate for dialysis services.</text> </paragraph> <paragraph num="E."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department will make supplemental payment on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible and coinsurance are to be paid in full; and</text> </paragraph> <paragraph num="(2)"> <text>Services not covered by Medicare are payable according to §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone; or</text> </paragraph> <paragraph num="(4)"> <text>Home visits unless satisfactorily documented as an emergency.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Program will make no direct payment to a participant.</text> </paragraph> <paragraph num="I."> <text>The Program will make no separate direct payment to any person employed by or under contract to any free-standing dialysis facility for services covered under this regulation.</text> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance or if any other person is obligated either legally or contractually to pay for, or to reimburse for, any service covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and by the insurace or other source, the provider shall refund the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with all applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Recovery of overpayments as specified in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Withholding part or all of the payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Permanent removal from the Program;</text> </paragraph> <paragraph num="(5)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department shall:</text> <paragraph num="(1)"> <text>Establish the:</text> <paragraph num="(a)"> <text>Effective date of the proposed action; and</text> </paragraph> <paragraph num="(b)"> <text>Reasons for the proposed action; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Advise the provider of the right to appeal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services which are provided without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 2, 1985 (12:24 Md. R. 2348)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 17, 2014 (41:3 Md. R. 201)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C adopted effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 26, 2018 (45:6 Md. R. 319)</annotation> </annotations> </chapter> <chapter num="23" heading="Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“American Academy of Pediatric Dentists” means the membership organization representing the specialty of pediatric dentistry.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program or its designee.</text> </paragraph> <paragraph num="(3)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other diagnostic and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses in children younger than 21 years old.</text> </paragraph> <paragraph num="(4)"> <text>“EPSDT periodicity schedule” means the State-specified listing of the minimum required and recommended preventive health screening services that are to be performed at specified ages.</text> </paragraph> <paragraph num="(5)"> <text>“EPSDT screen” means the full scope of comprehensive well-child screening procedures, required by the State periodicity schedule that a participant receives at a given age.</text> </paragraph> <paragraph num="(6)"> <text>“EPSDT screening provider” means a physician, nurse practitioner, or physician assistant certified by the Department to provide EPSDT screens.</text> </paragraph> <paragraph num="(7)"> <text>“EPSDT treatment provider” means a health care provider that is enrolled to provide services that are not otherwise covered for individuals 21 years old or older.</text> </paragraph> <paragraph num="(8)"> <text>“EPSDT treatment services” means health care services that are covered for children younger than 21 years old that are not otherwise covered for individuals 21 years old or older.</text> </paragraph> <paragraph num="(9)"> <text>“Environmental lead investigation” means an inspection of the primary dwelling of a participant that results in a report characterizing the hazards associated with identified lead-containing substances.</text> </paragraph> <paragraph num="(10)"> <text>Foster Care Child.</text> <paragraph num="(a)"> <text>“Foster care child” means a participant who is in the care and custody of the Department of Human Services.</text> </paragraph> <paragraph num="(b)"> <text>“Foster care child” includes children who receive kinship care.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or another state, to provide health care services.</text> </paragraph> <paragraph num="(12)"> <text>“Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Healthy Kids Program” means the unit within the Maryland Medical Assistance Program that develops guidelines for and monitors EPSDT well-child screening services and certifies EPSDT screening providers.</text> </paragraph> <paragraph num="(14)"> <text>“Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting.</text> </paragraph> <paragraph num="(15)"> <text>“Jurisdiction” means a state or the District of Columbia.</text> </paragraph> <paragraph num="(16)"> <text>“Managed Care Organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(18)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Participant” means a person younger than 21 years old who is determined eligible for, and is receiving, Medical Assistance benefits as provided in COMAR 10.09.11 or 10.09.24.</text> </paragraph> <paragraph num="(20)"> <text>“Plan of treatment” means a written plan, updated at a minimum of every 6 months for ongoing care, to address identified problems to include:</text> <paragraph num="(a)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(b)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(c)"> <text>Frequency of visits;</text> </paragraph> <paragraph num="(d)"> <text>Duration of treatment; and</text> </paragraph> <paragraph num="(e)"> <text>Prognosis.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Preauthorization” means the approval required from the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(22)"> <text>“Preventive services” means primary health care designed to:</text> <paragraph num="(a)"> <text>Promote normal growth and development; and</text> </paragraph> <paragraph num="(b)"> <text>Detect, ameliorate, or delay diseases at an early stage before complications or serious disabilities develop.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(24)"> <text>“Screening services” means the EPSDT preventive health care and laboratory procedures required at specified ages by the State periodicity schedule.</text> </paragraph> <paragraph num="(25)"> <text>“Third-party payers” means insurers and other entities obligated either legally or contractually to pay for or to reimburse the participant for service covered in this chapter.</text> </paragraph> <paragraph num="(26)"> <text>“Vaccines for Children Program” means the federal program that provides specific childhood vaccines to health care providers, at no cost, for administration to participants younger than 19 years old.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Incorporation by Reference."> <text>The Audiology, Physical Therapy, and Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual (Maryland Medical Assistance Program, Effective January 1, 2022) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Provider Qualifications."> <paragraph num="A."> <text>EPSDT screening and treatment providers shall meet all of the licensure and certification requirements specified in this or any other applicable chapter of COMAR, statute, or policy for the service that the provider renders.</text> </paragraph> <paragraph num="B."> <text>In order for the Program to consider a health care practitioner for certification by the Healthy Kids Program as an EPSDT screening provider, the practitioner shall have a demonstrated history of providing services to children younger than 21 years old and shall also:</text> <paragraph num="(1)"> <text>Be a doctor of medicine or osteopathy who is:</text> <paragraph num="(a)"> <text>Licensed in good standing and legally authorized to practice medicine and surgery in the jurisdiction in which the service is provided; and</text> </paragraph> <paragraph num="(b)"> <text>Board-certified in one of the following:</text> <paragraph num="(i)"> <text>Pediatrics;</text> </paragraph> <paragraph num="(ii)"> <text>Family practice; or</text> </paragraph> <paragraph num="(iii)"> <text>Internal medicine; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be a pediatric or family nurse practitioner or a physician assistant who is licensed in good standing and certified to practice in the jurisdiction in which services are provided.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A freestanding clinic as defined in COMAR 10.09.08 shall be considered for certification by the Healthy Kids Program as an EPSDT screening provider if the clinic employs or contracts with one or more of the licensed health care practitioners listed in §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Any health care practitioner whose professional services are recognized in §1905(a) of the Social Security Act may apply to the Program to be an EPSDT treatment provider.</text> </paragraph> <paragraph num="E."> <text>EPSDT treatment providers that are covered by the Program include:</text> <paragraph num="(1)"> <text>The following provider types that are licensed in good standing to practice in the jurisdiction in which services are provided:</text> <paragraph num="(a)"> <text>Chiropractors;</text> </paragraph> <paragraph num="(b)"> <text>Nurse psychotherapists;</text> </paragraph> <paragraph num="(c)"> <text>Nutritionists or dietitians;</text> </paragraph> <paragraph num="(d)"> <text>Occupational therapists;</text> </paragraph> <paragraph num="(e)"> <text>Professional counselors;</text> </paragraph> <paragraph num="(f)"> <text>Psychologists;</text> </paragraph> <paragraph num="(g)"> <text>Social workers;</text> </paragraph> <paragraph num="(h)"> <text>Speech therapists; or</text> </paragraph> <paragraph num="(i)"> <text>An intermediate care facility that provides at least one of the following:</text> <paragraph num="(i)"> <text>Clinically managed high intensity residential treatment; and</text> </paragraph> <paragraph num="(ii)"> <text>Medically monitored intensive inpatient treatment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Lead paint risk assessors who are accredited by the Maryland Department of the Environment in accordance with COMAR 26.16.01.16;</text> </paragraph> <paragraph num="(3)"> <text>Audiologists and hearing aid providers, as specified in COMAR 10.09.51.02;</text> </paragraph> <paragraph num="(4)"> <text>Dentists as specified in COMAR 10.09.05.02;</text> </paragraph> <paragraph num="(5)"> <text>Private duty nurses, as specified in COMAR 10.09.53.02;</text> </paragraph> <paragraph num="(6)"> <text>Residential treatment centers, as specified in COMAR 10.09.29.02;</text> </paragraph> <paragraph num="(7)"> <text>Therapeutic behavioral service providers, as specified in COMAR 10.09.34.02; and</text> </paragraph> <paragraph num="(8)"> <text>Vision care and optical providers, as specified in COMAR 10.09.14.02.</text> </paragraph> <paragraph num="(9)"> <text>Therapeutic nursery service providers, as specified in COMAR 10.21.18.03.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In order to qualify as an EPSDT treatment provider, an intermediate care facility shall:</text> <paragraph num="(1)"> <text>Be licensed under COMAR 10.63.03 or certified under COMAR 10.47.02, whichever is appropriate; and</text> </paragraph> <paragraph num="(2)"> <text>If appropriate, provide separate social, residential, dietary, and recreational activities for children and adolescents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>In order to receive payments as a Medicaid provider, providers shall meet the following general requirements:</text> <paragraph num="(1)"> <text>All conditions for participation set forth in COMAR 10.09.36;</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department;</text> </paragraph> <paragraph num="(3)"> <text>The licensure and provider qualification requirements in Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Verify the licenses and credentials of all professionals employed or contracted by the provider, and keep on file documentation of how that verification was completed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To be certified to participate in the Healthy Kids Program as an EPSDT screening provider, a provider shall agree to:</text> <paragraph num="(1)"> <text>Provide EPSDT comprehensive well-child services as outlined in the EPSDT periodicity schedule and in a manner prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Provide or arrange for referral, diagnosis, treatment, and follow-up when the screening indicates a need for additional services;</text> </paragraph> <paragraph num="(3)"> <text>Inform the parent or guardian of the next preventive health care visit, and assist with scheduling;</text> </paragraph> <paragraph num="(4)"> <text>Cooperate with Departmental efforts to assure that children receive needed follow-up and treatment services;</text> </paragraph> <paragraph num="(5)"> <text>Conform to the equipment, facilities, and procedural standards set by the Department;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a patient record system that is sufficiently detailed and current to allow another physician who is unfamiliar with the patient to properly continue treatment in the absence of the initial provider;</text> </paragraph> <paragraph num="(7)"> <text>Participate in the Vaccines for Children Program;</text> </paragraph> <paragraph num="(8)"> <text>Permit periodic on-site quality assurance visits by the Department or its designee following a protocol established by the Department to:</text> <paragraph num="(a)"> <text>Assure that the equipment necessary to perform required procedures is available;</text> </paragraph> <paragraph num="(b)"> <text>Review the charts of participants to assure delivery of EPSDT screens;</text> </paragraph> <paragraph num="(c)"> <text>Determine that required procedures are being performed correctly and that appropriate follow-up is provided; and</text> </paragraph> <paragraph num="(d)"> <text>Assess the need for any follow-up provider training, staff training, technical assistance, or in-service training; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Maintain a minimum score of 80 percent on all Healthy Kids Program quality assurance reviews.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO that has contracted with the Department shall ensure its enrollees have access to EPSDT comprehensive well-child services in accordance with COMAR 10.67.05.05A(3).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers all medically necessary care, including all health care services to identify and correct physical and mental problems that are covered in the State Plan, or that are allowable under the federal Medicaid program as described in §1905(a) of the Social Security Act.</text> </paragraph> <paragraph num="B."> <text>For a foster care child, the Program also covers upon entry to or moving within the foster care system:</text> <paragraph num="(1)"> <text>A brief initial check-up; and</text> </paragraph> <paragraph num="(2)"> <text>A comprehensive EPSDT screen as described in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program covers EPSDT comprehensive well-child services in accordance with the EPSDT periodicity schedule, which includes the following:</text> <paragraph num="(1)"> <text>EPSDT screening services which comprise the following:</text> <paragraph num="(a)"> <text>A comprehensive health and developmental history, including assessment of both physical and mental health and development;</text> </paragraph> <paragraph num="(b)"> <text>Age-appropriate immunizations;</text> </paragraph> <paragraph num="(c)"> <text>Age and risk appropriate laboratory tests, including blood lead levels that are required at specific ages regardless of risk;</text> </paragraph> <paragraph num="(d)"> <text>Comprehensive unclothed physical examination; and</text> </paragraph> <paragraph num="(e)"> <text>Health education and anticipatory guidance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Vision services that comprise:</text> <paragraph num="(a)"> <text>Vision screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule;</text> </paragraph> <paragraph num="(b)"> <text>Vision screening and vision services delivered by optometrists and opticians, including eyeglasses, as described in COMAR 10.09.14.04;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Hearing services that comprise:</text> <paragraph num="(a)"> <text>Hearing screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; and</text> </paragraph> <paragraph num="(b)"> <text>Hearing screening and hearing aid services, as described in COMAR 10.09.51.04; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Dental services, including:</text> <paragraph num="(a)"> <text>Oral health assessment by the EPSDT screening provider and referral to a dentist; and</text> </paragraph> <paragraph num="(b)"> <text>Dental services, as specified in COMAR 10.09.05.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Additional Medically Necessary Plan of Treatment Services.</text> <paragraph num="(1)"> <text>The Program also covers the EPSDT treatment services listed in §D(2) of this regulation when the services are:</text> <paragraph num="(a)"> <text>Necessary to identify, correct, or ameliorate defects and physical and mental illnesses and conditions;</text> </paragraph> <paragraph num="(b)"> <text>Rendered in accordance with accepted professional standards; and</text> </paragraph> <paragraph num="(c)"> <text>Delivered in accordance with a plan of treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>EPSDT services covered under §D of this regulation include:</text> <paragraph num="(a)"> <text>Chiropractic services;</text> </paragraph> <paragraph num="(b)"> <text>Mental health services or behavioral health services, or both, when the diagnosis of a participant is not included under the specialty mental health system, as described in COMAR 10.67.08.02;</text> </paragraph> <paragraph num="(c)"> <text>Nutritional counseling services;</text> </paragraph> <paragraph num="(d)"> <text>Occupational therapy services;</text> </paragraph> <paragraph num="(e)"> <text>Speech therapy services;</text> </paragraph> <paragraph num="(f)"> <text>Medically monitored intensive inpatient treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.14, whichever is applicable;</text> </paragraph> <paragraph num="(g)"> <text>Clinically managed high intensity residential treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable;</text> </paragraph> <paragraph num="(h)"> <text>Environmental lead investigations, as specified in COMAR 26.16.02.04 and .05 when there is a confirmed elevated blood lead level of the lower of the following values:</text> <paragraph num="(i)"> <text>3.5 micrograms or greater per deciliter, the current Maryland elevated blood lead level; or</text> </paragraph> <paragraph num="(ii)"> <text>The Centers for Disease Control and Prevention blood lead reference value;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Private duty nursing services, as specified in COMAR 10.09.53.04;</text> </paragraph> <paragraph num="(j)"> <text>Residential treatment services, as specified in COMAR 10.09.29.04; and</text> </paragraph> <paragraph num="(k)"> <text>Therapeutic behavioral services, as specified in COMAR 10.09.34.03.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Any Program limits on services or treatments identified in this regulation are not applicable for individuals younger than 21 years old if it is shown that the treatments or services are medically necessary to correct or ameliorate identified or suspected health problems.</text> </paragraph> <paragraph num="B."> <text>The dental covered services specified in COMAR 10.09.05.04, which follow the periodicity schedule issued by the American Academy of Pediatric Dentists, are limited to two dental examinations per participant per 12-month period.</text> </paragraph> <paragraph num="C."> <text>Vision services specified in COMAR 10.09.14.04, including eye examinations and eyeglasses or contact lenses, are limited to not more than once a year.</text> </paragraph> <paragraph num="D."> <text>Environmental lead investigations:</text> <paragraph num="(1)"> <text>Are limited to the child's primary dwelling;</text> </paragraph> <paragraph num="(2)"> <text>Are limited to one on-site inspection per dwelling; and</text> </paragraph> <paragraph num="(3)"> <text>Do not include testing of any substances sent to a laboratory for analysis.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The provider covered by this chapter may not bill the Program for:</text> <paragraph num="(1)"> <text>Services that are:</text> <paragraph num="(a)"> <text>Provided while the participant is in an institution for mental disease, a hospital, or a residential treatment center, as bundled payment for institutional stays includes EPSDT services;</text> </paragraph> <paragraph num="(b)"> <text>Custodial or assist with activities of daily living;</text> </paragraph> <paragraph num="(c)"> <text>Not medically necessary;</text> </paragraph> <paragraph num="(d)"> <text>Beyond the provider's scope of practice;</text> </paragraph> <paragraph num="(e)"> <text>Rendered but not appropriately documented;</text> </paragraph> <paragraph num="(f)"> <text>Part of another service paid for by the State; or</text> </paragraph> <paragraph num="(g)"> <text>Rendered not in person, unless the services are provided in compliance with COMAR 10.09.49 and any subregulatory guidance issued by the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Respite services;</text> </paragraph> <paragraph num="(3)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(4)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(5)"> <text>Supplies, equipment, or items that are not medical in nature; or</text> </paragraph> <paragraph num="(6)"> <text>Services that are primarily cosmetic in nature.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization."> <text>Preauthorization is required for:</text> <paragraph num="A."> <text>Certain audiology and hearing aid services, as specified in COMAR 10.09.51.06;</text> </paragraph> <paragraph num="B."> <text>Certain dental services, as specified in COMAR 10.09.05.06;</text> </paragraph> <paragraph num="C."> <text>Certain vision services, as specified in COMAR 10.09.14.06;</text> </paragraph> <paragraph num="D."> <text>Private duty nursing services, as specified in COMAR 10.09.53.06;</text> </paragraph> <paragraph num="E."> <text>Residential treatment services, as specified in COMAR 10.09.29.06;</text> </paragraph> <paragraph num="F."> <text>Therapeutic behavioral services, as specified in COMAR 10.09.34.05; and</text> </paragraph> <paragraph num="G."> <text>Intermediate Care Facilities, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Rates for services provided by chiropractors, speech therapists, occupational therapists, and nutritionists covered under this chapter are included in the Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual.</text> </paragraph> <paragraph num="D."> <text>Reimbursement of Medically Monitored Intensive Inpatient Treatment Services Provided in an Intermediate Care Facility.</text> <paragraph num="(1)"> <text>The Department may not directly reimburse any State-operated intermediate care facility for participants. The Department shall claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these intermediate care facilities.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall pay the intermediate care facility the lesser of:</text> <paragraph num="(a)"> <text>The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, up to a maximum of $400 per day.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The maximum payment in §D(2)(b) of this regulation will be updated annually by the Centers for Medicare and Medicaid Service’s published federal fiscal year market basket increase percentage relating to hospitals excluded from the prospective payment system.</text> </paragraph> <paragraph num="(4)"> <text>Submitting Cost Reports.</text> <paragraph num="(a)"> <text>Facilities reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413.40, as amended, shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If reports are not received within 3 months and the Department has not granted an extension, the Department shall withhold from the provider a maximum of 10 percent of the current interim payment for the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. There may not be a refund or adjustment for withholding in cost settlement.</text> </paragraph> <paragraph num="(b)"> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="(c)"> <text>The Department may grant an extension if:</text> <paragraph num="(i)"> <text>The provider makes a written request setting forth the specific reasons for the request; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department determines, taking into consideration the totality of the circumstances, that the request is reasonable.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, and the provider has not received an extension, the Department, in addition to withholding percentages of payment pursuant to §D(3)(a) of this regulation, may impose one or more sanctions as provided for in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(e)"> <text>If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department, if applicable, shall make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established may not exceed the maximum per diem rates in effect when the facility's costs were last settled.</text> </paragraph> <paragraph num="(f)"> <text>For purposes of §D(3)(a)—(e) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Participant’s Contribution.</text> <paragraph num="(a)"> <text>The local department of social services or the State-operated facility’s fiscal agent shall determine the amount the participant has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider.</text> </paragraph> <paragraph num="(b)"> <text>The provider shall collect from the participant that amount as shown available on the designated form.</text> </paragraph> <paragraph num="(c)"> <text>The provider may not collect a total amount, including the participant’s resource and the Department’s payment, which exceeds the provider’s rate established by the Department.</text> </paragraph> <paragraph num="(d)"> <text>The provider shall show to the Department sums collected from the participant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement for environmental lead investigation is $333.29 per inspection.</text> </paragraph> <paragraph num="F."> <text>Reimbursement for services covered in Regulation .04 of this chapter shall be the lower of the provider's charge for the service, or the Program's fee schedule.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>Regardless of whether the participant has other third-party insurance coverage, EPSDT screening providers shall bill the Program directly for the following components of an EPSDT screen:</text> <paragraph num="(1)"> <text>Comprehensive unclothed physical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Immunizations when the vaccine is not covered by the Vaccines for Children Program;</text> </paragraph> <paragraph num="(3)"> <text>Vaccine administration; and</text> </paragraph> <paragraph num="(4)"> <text>Objective screenings for:</text> <paragraph num="(a)"> <text>Developmental assessment;</text> </paragraph> <paragraph num="(b)"> <text>Hearing; and</text> </paragraph> <paragraph num="(c)"> <text>Vision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Upon submission of a claim for a EPSDT screening component, as described in §A of this regulation, the Department shall pursue third-party reimbursement when appropriate.</text> </paragraph> <paragraph num="C."> <text>Recovery and reimbursement for all other services in the chapter are set forth in COMAR 10.09.36.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal and impositions of sanctions are as set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>If during a quality assessment, the Department staff determines that the provider does not meet the standards established by the Department, the Department may decertify the provider as an EPSDT screening provider.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulations."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1983 (9:25 Md. R. 2483)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 12, 1984 (11:5 Md. R. 463); October 1, 1985 (12:19 Md. R. 1849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); amended permanently effective May 1, 1983 (10:7 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 1, 1985 (12:19 Md. R. 1849); March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective October 29, 1984 (11:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A-1 adopted effective February 13, 1984 (11:3 Md. R. 200)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective October 1, 1985 (12:19 Md. R. 1849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08F amended and .08G-1 adopted effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08F, J and .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); Regulation .08F, J amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Regulation .09A not amended permanently at this time—emergency status expired October 6, 1991)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08I amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended effective May 1, 1983 (10:8 Md. R. 725); February 13, 1984 (11:3 Md. R. 200); October 29, 1984 (11:21 Md. R. 1814); October 1, 1985 (12:19 Md. R. 1849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08L amended effective October 29, 1984 (11:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974); March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Table 1 amended effective February 13, 1984 (11:3 Md. R. 200); June 3, 1985 (12:11 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Table 2A adopted as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); adopted permanently effective May 1, 1983 (10:7 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Tables 1, 2, and 2A repealed effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Table 3 recodified as Table 1 effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 19, 1993 (20:14 Md. R. 1169)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 21, 2004 (31:12 Md. R. 911)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 repealed and new Regulations .01—.12 adopted effective March 22, 2010 (37:6 Md. R. 477)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective December 31, 2018 (45:26 Md. R. 1243); August 26, 2019 (46:17 Md. R. 726); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, E amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective December 27, 2010 (37:26 Md. R. 1787); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F adopted effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective December 27, 2010 (37:26 Md. R. 1787); October 26, 2015 (42:21 Md. R. 1300); July 3, 2017 (44:13 Md. R. 621); December 31, 2018 (45:26 Md. R. 1243); August 7, 2023 (50:15 Md. R. 681); March 16, 2026 (53:5 Md. R. 243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G adopted effective February 16, 2015 (42:3 Md. R. 315)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, E amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective September 30, 2013 (40:19 Md. R. 1544); February 1, 2016 (43:2 Md. R. 127); September 26, 2016 (43:19 Md. R. 1072); August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective August 7, 2023 (50:15 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed effective October 27, 2014 (41:21 Md. R. 1259)</annotation> </annotations> </chapter> <chapter num="24" heading="Medical Assistance Eligibility"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter governs the determination of eligibility for the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="B."> <text>Eligibility may be established for the following coverage groups:</text> <paragraph num="(1)"> <text>The MAGI coverage groups whose income standard is based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014; and</text> </paragraph> <paragraph num="(2)"> <text>The MAGI Exempt coverage groups whose income standard is based on Title XIX of the Social Security Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Aged” means a person who is 65 years old or older.</text> </paragraph> <paragraph num="(2)"> <text>“Aid to the Permanently and Totally Disabled” means a former category of public assistance mandated under Title XIV of the Social Security Act, 42 U.S.C. §1351 et seq., and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq.</text> </paragraph> <paragraph num="(3)"> <text>“Appeal” means a process by which an applicant, recipient, or representative obtains review of a decision, action, or inaction of the Department or the local department of social services.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means a person whose written application for Medical Assistance has been submitted to the local department of social services but has not received final action. This includes a person, who need not be alive at the time of application, whose application is submitted through a representative.</text> </paragraph> <paragraph num="(5)"> <text>“Application” means the filing of a written and signed application form for Medical Assistance at the local department of social services or its designee.</text> </paragraph> <paragraph num="(6)"> <text>“Application date” means the date on which a written, signed application is received by the local department of social services.</text> </paragraph> <paragraph num="(7)"> <text>“Application form” means the form designated by the Department to be completed, signed, and submitted to the local department of social services, or a designee, as an official application for Medical Assistance.</text> </paragraph> <paragraph num="(8)"> <text>“Assistance unit” means one person, or a group of persons whose eligibility for Medical Assistance benefits is determined in conjunction with each other.</text> </paragraph> <paragraph num="(9)"> <text>“Blindness” means a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of no greater than 20 degrees.</text> </paragraph> <paragraph num="(10)"> <text>Caretaker Relative.</text> <paragraph num="(a)"> <text>“Caretaker relative” means a parent or other person related by blood, marriage, or adoption and living with and caring for an unmarried child younger than 21 years old who is deprived of parental support due to death, continued absence from the home, incapacitation of a parent, or unemployment of the principal wage earner parent. A parent whose absence is occasioned solely by reason of the performance of active duty in the uniformed service of the United States is not considered absent from the home. The following relatives and their spouses meet this definition: father, mother, brother, sister, stepfather, stepmother, stepbrother, stepsister, uncle, aunt, first cousin, nephew or niece, and persons of preceding generations as denoted by the prefix of grand, great, and great-great; persons who legally adopt a child or his parent as well as the natural and other legally adopted children of these persons; and other relatives of adoptive parents in accordance with State law. A caretaker relative retains his status as a caretaker relative when the only child or children in his custody receives SSI benefits. This is the only instance when a caretaker relative without children in an assistance unit qualifies as a caretaker relative.</text> </paragraph> <paragraph num="(b)"> <text>“Continued absence from the home” means that the parent is out of the home, the nature of the absence either interrupts or terminates the parent's functioning as a provider of maintenance, physical care, or guidance for the child, and the known or indefinite duration of the absence precludes counting on the parent's performance of his function in planning for the present support or care of the child.</text> </paragraph> <paragraph num="(c)"> <text>“Incapacitation” means that a parent has a mental or physical defect, illness, or impairment which eliminates the parent's ability to support or care for the child and is expected to last for a period of at least 30 days.</text> </paragraph> <paragraph num="(d)"> <text>“Principal wage earner parent” means whichever parent, in a home in which both parents of a child are living, earned a greater amount of income in the period specified below:</text> <paragraph num="(i)"> <text>For initial eligibility, the 24 months immediately preceding the month in which application is filed on the basis of the unemployment of a parent;</text> </paragraph> <paragraph num="(ii)"> <text>For eligibility for each subsequent month of the certification period, the 24 months immediately preceding the current month.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Unemployed Parent.</text> <paragraph num="(i)"> <text>“Unemployed parent” means the principal wage earner parent who:</text> <paragraph num="(aa)"> <text>Has been unemployed for at least 30 days before the receipt of Medical Assistance; and</text> </paragraph> <paragraph num="(bb)"> <text>Has not left a job or refused to seek or accept employment without good cause within 30 days of the date of application.</text> </paragraph> </paragraph> <paragraph num="(ii)"> <text>The condition of unemployment is met when the parent is employed less than 100 hours per month; or is employed 100 hours or more per month, if the parent's work is intermittent and the excess hours are of a temporary nature, as evidenced by the fact that the work hours were under the standard for the two previous months and are expected to be under the standard during the next month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10-1)"> <text>“Carrier” means a:</text> <paragraph num="(a)"> <text>Health insurer;</text> </paragraph> <paragraph num="(b)"> <text>Non-profit health service plan;</text> </paragraph> <paragraph num="(c)"> <text>Health maintenance organization;</text> </paragraph> <paragraph num="(d)"> <text>Dental plan organization; and</text> </paragraph> <paragraph num="(e)"> <text>Any other person included as a third party in Section 1902(a)(25)(A) of the Social Security Act, as amended by the Federal Deficit Reduction Act of 2005.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Categorically needy” means aged, blind, or disabled persons, or families and children, who are otherwise eligible for Medical Assistance and who meet the financial eligibility requirements for FIP, SSI, or Optional State Supplement.</text> </paragraph> <paragraph num="(12)"> <text>“Child” means an unmarried person younger than 21 years old.</text> </paragraph> <paragraph num="(13)"> <text>“Chronic hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01.</text> </paragraph> <paragraph num="(14)"> <text>“Comprehensive care facility” means a nursing facility licensed as a comprehensive care facility pursuant to COMAR 10.07.02.</text> </paragraph> <paragraph num="(14-1)"> <text>“Continuing care retirement community (CCRC)” means an entity that obtains certificate of registration issued by the Maryland Department of Aging in accordance with COMAR 32.02.01 and pursuant to its authority under Article 70B, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Corrective Managed Care Program” means the program administered by the Division of Utilization and Eligibility Review of the Medical Care Compliance Administration which limits recipients who have abused or misused Medical Assistance benefits to access most covered services through a single primary medical provider and a single pharmacy.</text> </paragraph> <paragraph num="(16)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program.</text> </paragraph> <paragraph num="(17)"> <text>“Department of Human Services” means the department of State government which administers the FIP program.</text> </paragraph> <paragraph num="(18)"> <text>“Determination” means a decision regarding an applicant's eligibility for Medical Assistance.</text> </paragraph> <paragraph num="(19)"> <text>“Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which can be expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months.</text> </paragraph> <paragraph num="(20)"> <text>“Eligibility technician” means an employee of the local department of social services responsible for determining eligibility of applicants and recipients.</text> </paragraph> <paragraph num="(20-1)"> <text>“Emergency services” means services provided by a licensed medical practitioner after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing health in jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions;</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part; or</text> </paragraph> <paragraph num="(d)"> <text>Development or continuance of severe pain.</text> </paragraph> </paragraph> <paragraph num="(20-2)"> <text>“Entrance fee” means a sum of money or other consideration, other than a surcharge that:</text> <paragraph num="(a)"> <text>Is paid by a resident to a CCRC initially or in deferred payments, pursuant to a written continuing care agreement between the CCRC and the resident, which governs the use, treatment, and refund of the entrance fee;</text> </paragraph> <paragraph num="(b)"> <text>Assures a resident of continuing care in the CCRC facility for a term of more than 1 year or for life; and</text> </paragraph> <paragraph num="(c)"> <text>Is at least three times the weighted average of the monthly cost of the periodic fees charged to independent living and assisted living units.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Extended care facility” means a nursing facility licensed as an extended care facility pursuant to COMAR 10.07.02.</text> </paragraph> <paragraph num="(21-1)"> <text>“Family Investment Program (FIP)” means a category of public assistance mandated under Title IV-A of the Social Security Act, 42 U.S.C. §601 et seq.</text> </paragraph> <paragraph num="(21-2)"> <text>“Guardian of the person” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 7, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle.</text> </paragraph> <paragraph num="(21-3)"> <text>“Guardian of the property” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 2, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle.</text> </paragraph> <paragraph num="(22)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or is licensed according to applicable standards established by the state in which the hospital is located.</text> </paragraph> <paragraph num="(23)"> <text>Income.</text> <paragraph num="(a)"> <text>“Income” means any property or service received by a person in cash or in-kind which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses.</text> </paragraph> <paragraph num="(b)"> <text>“Earned income” means payment received by a person in cash or in-kind as a result of employment, including self-employment. Earned income consists of wages, salaries, commissions, tips, and profit from self-employment.</text> </paragraph> <paragraph num="(c)"> <text>“In-kind income” means support or benefits in the form of food or shelter, or both, received by a person.</text> </paragraph> <paragraph num="(d)"> <text>“Unearned income” means all income which does not meet the definition of earned income.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining an applicant's or recipient's eligibility for Public Assistance, Medical Assistance, and Medical Assistance, State-Only.</text> </paragraph> <paragraph num="(25)"> <text>“Incurred medical expenses” means those paid or unpaid bills for medical care which are recognized under State law and are or will be the obligation of the applicant.</text> </paragraph> <paragraph num="(26)"> <text>“Intermediate care facility” means a nursing facility which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11.</text> </paragraph> <paragraph num="(27)"> <text>“Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID)” means a nursing facility for the intellectually disabled which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11.</text> </paragraph> <paragraph num="(28)"> <text>“Living together” means sharing a common household.</text> </paragraph> <paragraph num="(29)"> <text>“Local department of social services (LDSS)” means the Baltimore City or a county social services department under the supervision of the Department of Human Services.</text> </paragraph> <paragraph num="(30)"> <text>“Long-term-care facility” means a skilled nursing facility, intermediate care facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or mental hospital.</text> </paragraph> <paragraph num="(31)"> <text>“Mandatory State Supplement” means a cash payment a state is required to make under Section 212, P.O. 93-66 to an aged, blind, or disabled person to provide him with the same amount of cash assistance he was receiving under Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind if his SSI payment is less than that amount.</text> </paragraph> <paragraph num="(31-1)"> <text>“Maryland Medicaid Managed Care Program” means the Medicaid reform program established under COMAR 10.67.01—.10, as authorized by Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act.</text> </paragraph> <paragraph num="(33)"> <text>“Medical Assistance (MA)” means the program administered by the State under Title XIX which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons.</text> </paragraph> <paragraph num="(34)"> <text>“Medical Care Compliance Administration” means the administrative unit of the Department responsible for ensuring that health care services provided to recipients are appropriate and effectively utilized.</text> </paragraph> <paragraph num="(35)"> <text>“Medical Care Operations Administration” means the administrative unit of the Department responsible for maintaining a file of all eligible persons and paying providers of service.</text> </paragraph> <paragraph num="(36)"> <text>“Health Systems Financing Administration” means the administrative unit of the Department responsible for establishing regulations, policies, and procedures for the Medical Assistance program.</text> </paragraph> <paragraph num="(37)"> <text>“Medical institution” means an institution that:</text> <paragraph num="(a)"> <text>Is organized to provide medical care, including nursing and convalescent care;</text> </paragraph> <paragraph num="(b)"> <text>Has the necessary professional personnel, equipment, and facilities to manage the medical, nursing, and other health needs of patients on a continuing basis in accordance with accepted standards;</text> </paragraph> <paragraph num="(c)"> <text>Is authorized under State law to provide medical care; and</text> </paragraph> <paragraph num="(d)"> <text>Is staffed by professional personnel who are responsible to the institution for professional medical and nursing services.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Medically needy” means persons who are otherwise eligible for Medical Assistance, who are not categorically needy, and whose income and resources are within the limits set under the State Plan.</text> </paragraph> <paragraph num="(39)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq.</text> </paragraph> <paragraph num="(40)"> <text>“Mental hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.04.</text> </paragraph> <paragraph num="(41)"> <text>“Migrant worker” means a person who moves from place to place to harvest or process seasonal crops.</text> </paragraph> <paragraph num="(42)"> <text>“Old Age Assistance” means a former category of public assistance mandated under Title I of the Social Security Act, and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq.</text> </paragraph> <paragraph num="(43)"> <text>“One-time-only” means a time-limited certification.</text> </paragraph> <paragraph num="(44)"> <text>“Optional State Supplement” means a cash payment made by a state to an aged, blind, or disabled person, under §1616 of the Social Security Act.</text> </paragraph> <paragraph num="(45)"> <text>“Period under consideration” means the specified months which are assessed for determination of eligibility.</text> </paragraph> <paragraph num="(45-1)"> <text>“Postpartum period” means the period of time beginning on the date a pregnancy ends and ending on the last day of the 12th month following the end of pregnancy.</text> </paragraph> <paragraph num="(46)"> <text>“Public Assistance” means cash assistance payments, including state supplementary payments, made to persons who are eligible for programs administered under Title IV-A or Title XVI of the Social Security Act.</text> </paragraph> <paragraph num="(47)"> <text>“Public Assistance to the Needy Blind” means a former category of public assistance mandated under Title X of the Social Security Act and replaced by Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq.</text> </paragraph> <paragraph num="(48)"> <text>Public Institution.</text> <paragraph num="(a)"> <text>“Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control.</text> </paragraph> <paragraph num="(b)"> <text>“Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more persons unrelated to the proprietor.</text> </paragraph> <paragraph num="(c)"> <text>“Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>Publicly Operated Community Residence that Serves No More Than 16 Residents.</text> <paragraph num="(a)"> <text>“Publicly operated community residence that serves no more than 16 residents” means a facility that is publicly operated, serves no more than 16 residents, and offers services beyond food and shelter.</text> </paragraph> <paragraph num="(b)"> <text>“Publicly operated community residence that serves no more than 16 residents” does not mean:</text> <paragraph num="(i)"> <text>Residential facilities located on or adjacent to any large institution or multipurpose center;</text> </paragraph> <paragraph num="(ii)"> <text>Educational or vocational institutions that primarily provide an approved or accredited program to some or all of their residents;</text> </paragraph> <paragraph num="(iii)"> <text>Medical treatment facilities which provide medical care or remedial service on an inpatient basis; or</text> </paragraph> <paragraph num="(iv)"> <text>Correctional or holding facilities which provide for persons who are prisoners, have been arrested or detained, or are held under court order as material witnesses or juveniles.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(49-1)"> <text>“Qualified alien” means an alien who:</text> <paragraph num="(a)"> <text>Has been fully admitted for permanent residence under the Immigration and Nationality Act (INA);</text> </paragraph> <paragraph num="(b)"> <text>Has been granted asylum under §208 of the INA;</text> </paragraph> <paragraph num="(c)"> <text>Has been admitted into the United States as a refugee under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year;</text> </paragraph> <paragraph num="(e)"> <text>Has had deportation withheld under §243(h) of the INA; or</text> </paragraph> <paragraph num="(f)"> <text>Has been granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980.</text> </paragraph> </paragraph> <paragraph num="(50)"> <text>“Recipient” means a person who is certified as eligible for Medical Assistance.</text> </paragraph> <paragraph num="(51)"> <text>“Redetermination” means a determination regarding continuing eligibility of a recipient.</text> </paragraph> <paragraph num="(52)"> <text>“Remedial service” means any service, other than a physician's service, provided within the scope of practice as defined by State law by a person licensed as a practitioner under State law.</text> </paragraph> <paragraph num="(53)"> <text>“Resources” means accumulated personal wealth over which a person has the authority or power to liquidate his interest, including cash savings, savings accounts, certificates of deposit, money market certificates, checking accounts, stocks, bonds, cash value of life insurance, burial plots, prepaid burial plans, real property, personal property, mortgages, and mutual funds.</text> </paragraph> <paragraph num="(54)"> <text>“Retroactive coverage” means the availability of coverage for incurred medical expenses covered under the State Plan for a period not to exceed 3 months before the month of application.</text> </paragraph> <paragraph num="(55)"> <text>“Skilled nursing facility” means a nursing facility which:</text> <paragraph num="(a)"> <text>Is licensed as a comprehensive care facility (SNF/CCF), or as an extended care facility (SNF/ECF), or both;</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements for certification and participation in Title XIX of the Social Security Act as a skilled nursing facility; and</text> </paragraph> <paragraph num="(c)"> <text>Has entered into a provider agreement with the Department pursuant to COMAR 10.09.10.</text> </paragraph> </paragraph> <paragraph num="(56)"> <text>“Social Security Administration” means the administrative unit in the United States Department of Health and Human Services responsible for administering programs under Titles II, IV-A, IV-D, and XVI of the Social Security Act.</text> </paragraph> <paragraph num="(57)"> <text>“Spend-down” means a procedure by which an applicant who is ineligible for Medical Assistance due to excess income becomes eligible by deducting incurred medical expenses from excess income.</text> </paragraph> <paragraph num="(58)"> <text>“Spouse” means a person who has been determined to be the husband or wife of another person under State law or for the purposes of determining eligibility for Social Security benefits.</text> </paragraph> <paragraph num="(59)"> <text>“State Plan” means a comprehensive written commitment by a Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of a medical assistance program in accordance with federal requirements.</text> </paragraph> <paragraph num="(60)"> <text>“Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq.</text> </paragraph> <paragraph num="(61)"> <text>“Third party” means a person, institution, corporation, public or private agency or organization who is or may be liable to pay all or part of the medical cost of injury, disease, or disability of an applicant or recipient.</text> </paragraph> <paragraph num="(62)"> <text>“Title XIX” means the title of the Social Security Act, 42 U.S.C. §§1396 et seq., which governs establishment of a medical assistance program for low income persons.</text> </paragraph> <paragraph num="(63)"> <text>“Tuberculosis hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02-1" heading="MAGI Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56).</text> </paragraph> <paragraph num="(2)"> <text>Authorized Representative” has the meaning stated in COMAR 10.01.04.12.</text> </paragraph> <paragraph num="(3)"> <text>“Designee” means any entity designated to act on behalf of the Department such as:</text> <paragraph num="(a)"> <text>Baltimore City or a county social services department under the supervision of the Department of Human Services;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore City Health Department and its subgrantees, or a county health department; and</text> </paragraph> <paragraph num="(c)"> <text>The Maryland Health Benefit Exchange.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Insurance Affordability Program” means a program that is one of the following:</text> <paragraph num="(i)"> <text>The Maryland State Medicaid program;</text> </paragraph> <paragraph num="(ii)"> <text>The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium;</text> </paragraph> <paragraph num="(iii)"> <text>An optional State basic health program established under §1331 of the Affordable Care Act;</text> </paragraph> <paragraph num="(iv)"> <text>A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; and</text> </paragraph> <paragraph num="(v)"> <text>A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act.</text> </paragraph> <paragraph num="(6)"> <text>“MAGI exempt coverage group” means a coverage group as described under Regulation .03 of this chapter whose eligibility is not determined by MAGI or by the Maryland Health Benefit Exchange.</text> </paragraph> <paragraph num="(7)"> <text>“Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Coverage Groups."> <paragraph num="A."> <text>The following individuals, including recipients of Temporary Cash Assistance, may be determined eligible for the MAGI coverage groups:</text> <paragraph num="(1)"> <text>Parents and other caretaker relatives whose household income is equal to or less than 123 percent of the federal poverty level;</text> </paragraph> <paragraph num="(2)"> <text>Pregnant and postpartum women of any age whose household income is equal to or less than 250 percent of the federal poverty level;</text> </paragraph> <paragraph num="(3)"> <text>Adults 19 years old or older and younger than 65 years old who are not entitled to or enrolled in Medicare Part A or Part B, whose household income is equal to or less than 133 percent of the federal poverty level, including adults living with dependent children who have provided minimum essential health care coverage for those children;</text> </paragraph> <paragraph num="(4)"> <text>Children younger than 21 years old and whose household income is equal to or less than 133 percent of the federal poverty level; and</text> </paragraph> <paragraph num="(5)"> <text>Former Foster Care individuals who:</text> <paragraph num="(a)"> <text>For individuals who turned 18 years old before January 1, 2023:</text> <paragraph num="(i)"> <text>Are younger than 26 years old;</text> </paragraph> <paragraph num="(ii)"> <text>Are not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and</text> </paragraph> <paragraph num="(iii)"> <text>Were formerly in a Maryland out-of-home placement, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For individuals who turned 18 years old on or after January 1, 2023:</text> <paragraph num="(i)"> <text>Are younger than 26 years old;</text> </paragraph> <paragraph num="(ii)"> <text>Are not enrolled for coverage under an eligibility group described in §1902(a)(10)(A)(i)(I)—(VII) of the Act; and</text> </paragraph> <paragraph num="(iii)"> <text>Were formerly in an out-of-home placement in any state, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An individual receiving SSI, Mandatory State Supplement, or Optional State Supplement is eligible for the MAGI Exempt coverage groups without having to file a separate application and covered as Categorically Needy.</text> </paragraph> <paragraph num="C."> <text>Transitional Medical Assistance.</text> <paragraph num="(1)"> <text>If a family loses Medical Assistance solely because of increased income from employment of the caretaker relative as defined under Regulation .02B(10)(a) of this chapter, all members of the family shall be eligible for Medical Assistance during the immediately succeeding 12-month period if the parents or caretaker relatives were eligible for Medical Assistance under §A(5) of this regulation in 3 or more months of the 6-month period immediately preceding the month in which they became ineligible for Medical Assistance.</text> </paragraph> <paragraph num="(2)"> <text>Termination of Transitional Medical Assistance.</text> <paragraph num="(a)"> <text>Transitional Medical Assistance during the 12-month period described under §C(1) of this regulation shall terminate at the close of the first month in which the family ceases to include a child younger than 21 years old.</text> </paragraph> <paragraph num="(b)"> <text>Termination of assistance may not become effective until the Department has provided the family with notice of the grounds for the termination.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Continuation in Certain Cases until Redetermination. With respect to a person who would cease to receive Medical Assistance under §C(2) of this regulation but who may be eligible for Medical Assistance under this chapter, the Department may not discontinue Medical Assistance until the Department has determined that the person is not eligible for Medical Assistance under this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application for Medical Assistance and, if determined eligible, are covered as Categorically Needy:</text> <paragraph num="(1)"> <text>An individual who would be eligible for SSI, or Optional State Supplement benefits except for a requirement of those programs that is specifically prohibited under Title XIX.</text> </paragraph> <paragraph num="(2)"> <text>A person who in December, 1973, was eligible for Medical Assistance as an essential spouse. Medical Assistance will continue if this person:</text> <paragraph num="(a)"> <text>Continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind plans to be considered an essential spouse; and</text> </paragraph> <paragraph num="(b)"> <text>Lives with an aged, blind, or disabled spouse who continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plans.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A person who in the month of December, 1973, was eligible for Medical Assistance and was an inpatient in a long-term care facility qualified to receive Medical Assistance payments, and, if not institutionalized, would have been eligible for Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled. Medical Assistance will continue if this person:</text> <paragraph num="(a)"> <text>Needed and received inpatient care continuously since December, 1973;</text> </paragraph> <paragraph num="(b)"> <text>Continues to need and receive inpatient care; and</text> </paragraph> <paragraph num="(c)"> <text>Continues to meet the eligibility criteria of the Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plan for December, 1973.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A person who:</text> <paragraph num="(a)"> <text>Meets all current requirements for Medical Assistance eligibility except the criteria for blindness or disability;</text> </paragraph> <paragraph num="(b)"> <text>Was eligible for Medical Assistance in December, 1973, as a blind or disabled person, whether or not he was receiving cash assistance in December, 1973; and</text> </paragraph> <paragraph num="(c)"> <text>For each consecutive month after December, 1973, continues to meet the criteria for blindness or disability and the other conditions of eligibility used under the Medical Assistance plan in December, 1973.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application, and if determined eligible, are covered as Medically Needy:</text> <paragraph num="(1)"> <text>A pregnant woman who has been denied AFDC solely because her income or resources exceed the cash assistance level;</text> </paragraph> <paragraph num="(2)"> <text>A person younger than 21 years old;</text> </paragraph> <paragraph num="(3)"> <text>A caretaker relative (and spouse);</text> </paragraph> <paragraph num="(4)"> <text>An aged, blind, or disabled person; and</text> </paragraph> <paragraph num="(5)"> <text>A person who was eligible as Medically Needy in December, 1973, on the basis of the blindness or disability criteria of Aid to the Permanently and Totally Disabled or Public Assistance to the Needy Blind and who continues to meet current requirements except for blindness or disability criteria.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Continuous Eligibility for Pregnant Women. The Department will provide Medical Assistance through the last day of the month in which the postpartum period ends for a pregnant woman who:</text> <paragraph num="(1)"> <text>Was eligible and enrolled under §A(2) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Because of a change in household income, will not otherwise remain eligible.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Coverage Group for Women with Breast or Cervical Cancer — Purpose, Definitions, and Eligibility Criteria."> <paragraph num="A."> <text>Purpose.</text> <paragraph num="(1)"> <text>The purpose of Regulations .03-1 and .03-2 of this chapter is to exercise the State's option under Title XIX of the Social Security Act to create a new Medical Assistance optional categorically needy coverage group for women who need treatment for breast cancer, cervical cancer, or precancerous conditions, in accordance with the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (Public Law 106-354).</text> </paragraph> <paragraph num="(2)"> <text>Applications submitted under Regulations .03-1 and .03-2 of this chapter shall no longer be accepted after December 31, 2013.</text> </paragraph> <paragraph num="(3)"> <text>An individual who has submitted an application in accordance with §A(1) of this regulation and who has been determined eligible will receive benefits under Regulations .03-1 and .03-2 of this chapter after December 31, 2013.</text> </paragraph> <paragraph num="(4)"> <text>Effective July 31, 2024, any individual who was previously covered under §A(3) of this regulation will no longer receive benefits under Regulations .03-1 and .03-2 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Definitions. In Regulations .03-1 and .03-2 of this chapter, the following terms have the meanings indicated:</text> <paragraph num="(1)"> <text>“Applicant” means an individual whose application for the Medical Assistance eligibility under the women's breast and cervical cancer coverage group has been submitted to the Department or its authorized representative, but has not received final action.</text> </paragraph> <paragraph num="(2)"> <text>“Application date” means the date on which a written, signed application for Medical Assistance eligibility under the women's breast and cervical cancer coverage group is received by the Department or its authorized representative.</text> </paragraph> <paragraph num="(3)"> <text>“Breast and Cervical Cancer Diagnosis and Treatment Program” means the State-funded program of cancer diagnosis and treatment services, which is:</text> <paragraph num="(a)"> <text>Governed by COMAR 10.14.02; and</text> </paragraph> <paragraph num="(b)"> <text>Administered by the Department's Center for Cancer Surveillance and Control.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Cancer treatment services” means active medical treatment for breast cancer, cervical cancer, or a precancerous condition, not including palliative care.</text> </paragraph> <paragraph num="(5)"> <text>“Categorically needy coverage group” means a category of Medical Assistance eligibility defined at Regulation .03A of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Creditable health insurance coverage” means having one or more of the following types of coverage:</text> <paragraph num="(a)"> <text>A group health plan;</text> </paragraph> <paragraph num="(b)"> <text>Health insurance coverage with medical care benefits provided directly or through insurance, reimbursement, or otherwise and including items and services paid for as medical care, under any:</text> <paragraph num="(i)"> <text>Hospital or medical service policy or certificate;</text> </paragraph> <paragraph num="(ii)"> <text>Hospital or medical service plan contract; or</text> </paragraph> <paragraph num="(iii)"> <text>Health maintenance organization contract offered by a health insurance issuer;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Medicare Part A or Part B;</text> </paragraph> <paragraph num="(d)"> <text>Medical Assistance;</text> </paragraph> <paragraph num="(e)"> <text>Armed forces insurance; or</text> </paragraph> <paragraph num="(f)"> <text>A state health risk pool.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Enrollee” means a woman who is determined eligible and is receiving Medical Assistance benefits under Regulations .03-1 and .03-2 of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Health professional” means a licensed physician or certified registered nurse practitioner.</text> </paragraph> <paragraph num="(9)"> <text>“Institutionalized person” has the meaning specified at Regulation .08B of this chapter.</text> </paragraph> <paragraph num="(10)"> <text>“Mandatory Medical Assistance categorically needy coverage group” means a Medical Assistance categorically needy coverage group which the federal government requires a state to cover under the State Plan, in accordance with the Code of Federal Regulations.</text> </paragraph> <paragraph num="(11)"> <text>“Maryland Breast and Cervical Cancer Screening Program” means the National Breast and Cervical Cancer Early Detection Program in Maryland which:</text> <paragraph num="(a)"> <text>Is funded by the State or federal government;</text> </paragraph> <paragraph num="(b)"> <text>Is administered by the Department's Center for Cancer Surveillance and Control through the local jurisdictions; and</text> </paragraph> <paragraph num="(c)"> <text>Has income and other eligibility requirements.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“National Breast and Cervical Cancer Early Detection Program (NBCCEDP)” means the program of the Centers for Disease Control (CDC), established under Title XV of the Public Health Service Act.</text> </paragraph> <paragraph num="(13)"> <text>“Needs treatment” means that, according to a written certification by a health professional, the individual needs cancer treatment services, such as chemotherapy, radiation, or surgery.</text> </paragraph> <paragraph num="(14)"> <text>“Precancerous condition” means for:</text> <paragraph num="(a)"> <text>Cervical cancer, a condition diagnosed as cervical intra-epithelial neoplasia I, II, or III; or</text> </paragraph> <paragraph num="(b)"> <text>Breast cancer, a condition diagnosed as atypical ductal hyperplasia or lobular carcinoma in-situ.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Screening services” means services provided by the Maryland Breast and Cervical Cancer Screening Program to screen for breast or cervical cancer, including clinical breast examinations, mammograms, pelvic examinations, Papanicolaou (Pap) tests, and diagnostic services such as breast ultrasound or colposcopically directed biopsy, to ensure that all women with abnormal screening results receive timely and adequate diagnostic and treatment services.</text> </paragraph> <paragraph num="(16)"> <text>“Uninsured” means:</text> <paragraph num="(a)"> <text>Not otherwise having creditable health insurance coverage for cancer treatment services; or</text> </paragraph> <paragraph num="(b)"> <text>Having creditable health insurance coverage, but the cancer treatment services ordered by a health professional are not covered due to one of the following reasons:</text> <paragraph num="(i)"> <text>The services are not included among the benefits covered by the individual's health insurance plan;</text> </paragraph> <paragraph num="(ii)"> <text>A period of exclusion has been applied to the individual's health insurance coverage, such as for a preexisting condition; or</text> </paragraph> <paragraph num="(iii)"> <text>The individual has exhausted the health insurance plan's covered benefits.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Women's breast and cervical cancer coverage group” means the Medical Assistance optional categorically needy coverage group covered under Regulations .03-1 and .03-2 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Eligibility.</text> <paragraph num="(1)"> <text>The Department shall determine that an applicant or enrollee is eligible for Medical Assistance coverage under Regulations .03-1 and .03-2 of this chapter if the individual:</text> <paragraph num="(a)"> <text>Is a woman;</text> </paragraph> <paragraph num="(b)"> <text>Is 40—64 years old;</text> </paragraph> <paragraph num="(c)"> <text>Is uninsured, with the Department not requiring a waiting period of prior uninsurance;</text> </paragraph> <paragraph num="(d)"> <text>Received screening services, in accordance with Regulation .03-2A of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Had a biopsy through the:</text> <paragraph num="(i)"> <text>Maryland Breast and Cervical Cancer Screening Program which resulted in a diagnosis of cervical cancer or a precancerous condition; or</text> </paragraph> <paragraph num="(ii)"> <text>Breast and Cervical Cancer Diagnosis and Treatment Program which resulted in a diagnosis of breast cancer or a precancerous condition;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Needs treatment;</text> </paragraph> <paragraph num="(g)"> <text>Is not an institutionalized person;</text> </paragraph> <paragraph num="(h)"> <text>Meets the nonfinancial eligibility requirements for Medical Assistance, as specified in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(i)"> <text>Is not eligible for a mandatory Medical Assistance categorically needy coverage group.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The requirements in this chapter related to financial eligibility, income, and resources:</text> <paragraph num="(a)"> <text>Shall apply for assessing eligibility for a mandatory Medical Assistance categorically needy coverage group; and</text> </paragraph> <paragraph num="(b)"> <text>May not apply for determining eligibility for the WBCCHP under Regulations .03-1 and 03-2 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-2" heading="Coverage Group for Women with Breast or Cervical Cancer — Eligibility, Determination, and Covered Services Process."> <paragraph num="A."> <text>Screening. A woman is considered to have received screening services if the:</text> <paragraph num="(1)"> <text>NBCCEDP funded all or part of the woman's screening services; or</text> </paragraph> <paragraph num="(2)"> <text>NBCCEDP did not fund all or part of the woman's screening services, but the screening services were rendered by a provider or entity funded at least in part by the NBCCEDP and the:</text> <paragraph num="(a)"> <text>Screening services were within the scope of a grant, subgrant, or contract under the State's NBCCEDP; or</text> </paragraph> <paragraph num="(b)"> <text>NBCCEDP grantee elected to include such screening services by that provider as screening services pursuant to the NBCCEDP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Assistance Unit. An applicant or enrollee shall be considered as an assistance unit of one person, including only the applicant or enrollee.</text> </paragraph> <paragraph num="C."> <text>Application Process. The requirements of Regulation .04 of this chapter shall apply, except for the following differences for the women's breast and cervical cancer coverage group:</text> <paragraph num="(1)"> <text>For the initial eligibility application, an individual shall apply through the Maryland Breast and Cervical Cancer Screening Program in the local jurisdiction;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's or enrollee's written application for an initial determination or a redetermination shall be on the form designated by the Department for the women's breast and cervical cancer coverage group;</text> </paragraph> <paragraph num="(3)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Determine initial eligibility, retroactive or current, based on:</text> <paragraph num="(i)"> <text>A signed application received from the applicant;</text> </paragraph> <paragraph num="(ii)"> <text>A form signed by a health professional, certifying that the enrollee needs treatment and, for a redetermination, specifying the anticipated length of treatment;</text> </paragraph> <paragraph num="(iii)"> <text>Confirmation from the Maryland Breast and Cervical Cancer Screening Program that the applicant received screening services in accordance with §A of this regulation;</text> </paragraph> <paragraph num="(iv)"> <text>Confirmation from the Maryland Breast and Cervical Cancer Screening Program or the Breast and Cervical Cancer Diagnosis and Treatment Program that the applicant had a biopsy which resulted in a diagnosis of breast cancer, cervical cancer, or a precancerous condition; and</text> </paragraph> <paragraph num="(v)"> <text>Additional information obtained by the Department to verify the applicant's eligibility in accordance with Regulation .03-1C of this chapter;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Redetermine an enrollee's eligibility at least every 12 months, before the end of the certification period, based on the following:</text> <paragraph num="(i)"> <text>An application completed by the enrollee, verifying continuing eligibility under Regulations .03-1 and .03-2 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>A certification form completed by a health professional, verifying that the enrollee needs treatment and specifying the expected length of treatment;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Verify, before determining or redetermining eligibility, that the applicant or enrollee is not:</text> <paragraph num="(i)"> <text>Currently covered by Medical Assistance and does not have an application under consideration in a coverage group which covers all State Plan services without requiring spend down or payment of a premium; or</text> </paragraph> <paragraph num="(ii)"> <text>Eligible for a mandatory Medical Assistance categorically needy coverage group;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Determine or redetermine eligibility within 45 days after receipt of a signed application;</text> </paragraph> <paragraph num="(e)"> <text>Refer the applicant or recipient to the local department of social services or local health department for an eligibility determination or redetermination if the individual may be eligible for a mandatory Medical Assistance categorically needy coverage group; and</text> </paragraph> <paragraph num="(f)"> <text>Notify the applicant or enrollee of the eligibility decision and the rights for appeal and fair hearing, in accordance with Regulation .13 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Based on the application date, the Department shall establish a period under consideration, which shall be:</text> <paragraph num="(a)"> <text>For retroactive eligibility for an initial application, not more than 3 months immediately preceding the month of application, if as of this earlier date the applicant would have met the requirements at Regulation .03-1C of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>For current eligibility for an initial application, a 12-month period beginning with the month of application; or</text> </paragraph> <paragraph num="(c)"> <text>For current eligibility for a redetermination, the lesser of:</text> <paragraph num="(i)"> <text>A 12-month period; or</text> </paragraph> <paragraph num="(ii)"> <text>The number of months that the individual needs treatment.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Certification Period.</text> <paragraph num="(1)"> <text>An enrollee's certification period shall begin:</text> <paragraph num="(a)"> <text>For retroactive eligibility with the initial determination, the first day of the month which is up to 3 months preceding the month of the application date if, as of this earlier date, the applicant would have met the requirements of Regulation .03-1C of this chapter, including having been screened for and diagnosed with breast cancer, cervical cancer, or a precancerous condition;</text> </paragraph> <paragraph num="(b)"> <text>For current eligibility with the initial determination, the first day of the month of the application date; or</text> </paragraph> <paragraph num="(c)"> <text>For a redetermination, the first day of the month immediately following the month in which the previous certification period ended.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The effective date for retroactive or current coverage under Regulations .03-1 and .03-2 of this chapter shall be April 1, 2002 or later.</text> </paragraph> <paragraph num="(3)"> <text>An enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter shall end as of the:</text> <paragraph num="(a)"> <text>End of a certification period for a:</text> <paragraph num="(i)"> <text>12-month period; or</text> </paragraph> <paragraph num="(ii)"> <text>A period less than 12 months, based on how long the enrollee needs treatment; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Date when the enrollee is no longer eligible under Regulations .03-1 and .03-2 of this chapter due to:</text> <paragraph num="(i)"> <text>Death;</text> </paragraph> <paragraph num="(ii)"> <text>Establishment of residency in another state;</text> </paragraph> <paragraph num="(iii)"> <text>Becoming 65 years old;</text> </paragraph> <paragraph num="(iv)"> <text>Becoming an institutionalized person; or</text> </paragraph> <paragraph num="(v)"> <text>No longer being uninsured, such as becoming eligible for another Medical Assistance coverage group which covers all State Plan services without requiring spend down or payment of a premium.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Redetermination.</text> <paragraph num="(1)"> <text>Scheduled Redeterminations.</text> <paragraph num="(a)"> <text>The Department shall issue a redetermination package to an enrollee at least 60 days before the end of the certification period.</text> </paragraph> <paragraph num="(b)"> <text>Based on the information presented, the Department shall determine whether the enrollee:</text> <paragraph num="(i)"> <text>Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new 12-month certification period, because the enrollee needs treatment for at least 12 more months;</text> </paragraph> <paragraph num="(ii)"> <text>Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new certification period of less than 12 months, based on the length of time that the enrollee needs treatment;</text> </paragraph> <paragraph num="(iii)"> <text>Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the required information was not received by the Department by the specified deadline, but shall be considered for continuing eligibility under the women's breast and cervical cancer coverage group if the necessary information is received by the Department within 6 months of the date of termination;</text> </paragraph> <paragraph num="(iv)"> <text>Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group and does not appear to qualify for a mandatory Medical Assistance categorically needy coverage group; or</text> </paragraph> <paragraph num="(v)"> <text>Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the enrollee may qualify for a mandatory Medical Assistance categorically needy coverage group, and shall be referred for an eligibility determination at the local department of social services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unscheduled Redeterminations.</text> <paragraph num="(a)"> <text>An enrollee shall inform the Department within 10 days of a change in circumstances, which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>If the Department receives notice of a change in circumstances which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter, the Department shall follow the procedures in §E(1)(b) of this regulation for redeterminations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Department determines as part of a scheduled or unscheduled redetermination that an enrollee does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group, the Department shall determine whether the individual qualifies for any other coverage groups under this chapter or COMAR 10.09.11.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Covered Services. Enrollees shall be entitled to full coverage for all services covered under the State Plan, not limited to cancer treatment services, except for enrollment in:</text> <paragraph num="(1)"> <text>The HealthChoice Maryland Medicaid Managed Care Program, in accordance with COMAR 10.09.62 — 10.09.67;</text> </paragraph> <paragraph num="(2)"> <text>Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69;</text> </paragraph> <paragraph num="(3)"> <text>A home and community-based services waiver under §1915(c) of Title XIX of the Social Security Act;</text> </paragraph> <paragraph num="(4)"> <text>Medicare buy-in for Medical Assistance payment of Medicare premiums, copayments, and deductibles for Medicare eligible persons;</text> </paragraph> <paragraph num="(5)"> <text>Program of All-Inclusive Care for the Elderly; or</text> </paragraph> <paragraph num="(6)"> <text>Coverage for services in a long-term care facility exceeding 30 consecutive days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-3" heading="Medicare Savings Program Coverage."> <paragraph num="A."> <text>Non-Financial and Resource Eligibility for the Medicare Savings Programs. In order to be eligible for the Medicare savings program under §§E—H of this regulation, an individual:</text> <paragraph num="(1)"> <text>May not be enrolled in Medical Assistance or the Maryland Children's Health Program under this chapter or under COMAR 10.09.11;</text> </paragraph> <paragraph num="(2)"> <text>Shall be entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums;</text> </paragraph> <paragraph num="(3)"> <text>Shall meet the non-financial eligibility requirements for Medical Assistance under this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Shall be part of an assistance unit whose countable resources do not exceed:</text> <paragraph num="(a)"> <text>For individuals eligible under §§E—G of this regulation, 3 times the maximum amount allowed by the Supplemental Security Income program, as adjusted from time to time by the Social Security Administration, for the number of persons in the assistance unit; or</text> </paragraph> <paragraph num="(b)"> <text>For individuals eligible under §H of this regulation, 2 times the maximum amount allowed by the Supplemental Security Income program for the number of persons in the assistance unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Medicare Savings Program.</text> <paragraph num="(1)"> <text>The Medical Assistance benefits for individuals eligible under §§E—H of this regulation are limited to the Medicare savings program benefits described under those sections of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Current eligibility for Medicare savings program benefits shall continue until the recipient is determined ineligible.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application and Redetermination Procedures.</text> <paragraph num="(1)"> <text>The requirements under this chapter for applications and redeterminations shall apply for §§E—H of this regulation except as described in §C(2)—(5) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Applications and re-applications for eligibility under this regulation shall be filed at:</text> <paragraph num="(a)"> <text>The Department or its designee;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Department of Aging;</text> </paragraph> <paragraph num="(c)"> <text>An area agency on aging; or</text> </paragraph> <paragraph num="(d)"> <text>A surrogate organization approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The initial application may be made at a face-to-face interview or by mail with an agency defined under §C(2) of this regulation, as authorized by the Department.</text> </paragraph> <paragraph num="(4)"> <text>Redeterminations.</text> <paragraph num="(a)"> <text>Applications for redetermination of eligibility shall be mailed by the Department or its designee to the recipient or representative for completion at least once every 12 months.</text> </paragraph> <paragraph num="(b)"> <text>The recipient or representative shall return the application to the Department or its designee and indicate:</text> <paragraph num="(i)"> <text>Any changes that have occurred since the prior redetermination of eligibility, such as a new address; or</text> </paragraph> <paragraph num="(ii)"> <text>That there is no new information to report, by marking “NO CHANGE” on the front of the application.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Upon notice of a change in circumstances, a redetermination of eligibility under §§E—H of this regulation shall be completed by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Eligibility under §§E—H of this regulation shall be initially determined and redetermined by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Income and Resource Consideration.</text> <paragraph num="(1)"> <text>Assistance Unit. When financial eligibility is determined for an applicant or recipient under §§E—H of this regulation, the countable income and resources of the following individuals shall be considered and measured against the income and resource standards specified in this regulation for the number of persons in the assistance unit:</text> <paragraph num="(a)"> <text>The applicant or recipient; and</text> </paragraph> <paragraph num="(b)"> <text>The applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Determining Countable Income and Resources.</text> <paragraph num="(a)"> <text>Income and resources shall be evaluated for §§E—H of this regulation in accordance with the provisions for aged, blind, or disabled adults residing in the community, as described under this chapter, in addition to the following resource exclusions:</text> <paragraph num="(i)"> <text>The cash value of life insurance; and</text> </paragraph> <paragraph num="(ii)"> <text>An amount up to $1,500 for burial or funeral funds, unless included in the annual resource limit for the full Medicare Part D Low-Income Subsidy (LIS) program.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Cost of Living Disregard. The annual cost of living increase in Social Security income under Title II of the Social Security Act shall be disregarded through the month following the month in which the annual federal poverty level update is published in the Federal Register.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Qualified Medicare Beneficiary (QMB).</text> <paragraph num="(1)"> <text>An individual is eligible for QMB benefits if:</text> <paragraph num="(a)"> <text>All of the requirements of §A of this regulation are satisfied; and</text> </paragraph> <paragraph num="(b)"> <text>The assistance unit's net countable income does not exceed 100 percent of the federal poverty level for the number of persons in the assistance unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Current eligibility for QMB benefits shall be effective the first day of the month after the month in which QMB eligibility is determined.</text> </paragraph> <paragraph num="(3)"> <text>Retroactive coverage before the month of application is not available for QMB benefits.</text> </paragraph> <paragraph num="(4)"> <text>Medicare savings program benefits for a QMB-eligible person shall include coverage of the following expenses by the Medical Assistance program:</text> <paragraph num="(a)"> <text>Monthly premium for Medicare Part B;</text> </paragraph> <paragraph num="(b)"> <text>Monthly premium for Medicare Part A, if the individual, due to insufficient working quarters, is not entitled to free coverage by the Social Security Administration; and</text> </paragraph> <paragraph num="(c)"> <text>Medicare Part A and Part B deductibles and co-insurance for services covered by Medicare, regardless of whether the services are covered under the Medical Assistance State Plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Specified Low-Income Medicare Beneficiary (SLMB).</text> <paragraph num="(1)"> <text>An individual is eligible for SLMB benefits if:</text> <paragraph num="(a)"> <text>All of the requirements of §A of this regulation are satisfied; and</text> </paragraph> <paragraph num="(b)"> <text>The assistance unit's net countable income is greater than 100 percent but less than 120 percent of the federal poverty level for the number of persons in the assistance unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Current eligibility for SLMB benefits shall be effective the first day of the month of application.</text> </paragraph> <paragraph num="(3)"> <text>An individual may qualify for retroactive SLMB benefits for up to 3 calendar months before the month of application, if the person meets the SLMB eligibility criteria for each of those prior months.</text> </paragraph> <paragraph num="(4)"> <text>Medicare savings program benefits for a SLMB-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Qualifying Individual QI.</text> <paragraph num="(1)"> <text>An individual is eligible for QI benefits if:</text> <paragraph num="(a)"> <text>All of the requirements of §A of this regulation are satisfied;</text> </paragraph> <paragraph num="(b)"> <text>The assistance unit's net countable income is at least 120 percent but less than 135 percent of the federal poverty level for the number of persons in the assistance unit; and</text> </paragraph> <paragraph num="(c)"> <text>The individual is not otherwise eligible for Medical Assistance under this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Current eligibility for QI benefits shall be effective the first day of the month of application.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may qualify for up to 3 calendar months before the month of application for retroactive QI benefits if:</text> <paragraph num="(a)"> <text>The individual meets the QI eligibility criteria for each of those prior months under consideration; and</text> </paragraph> <paragraph num="(b)"> <text>Each retroactive month is no earlier than January 1 of the calendar year in which the individual applied for QI benefits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Medicare savings program benefits for a QI eligible individual shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Qualified Disabled and Working Individual (QDWI).</text> <paragraph num="(1)"> <text>An individual is eligible for QDWI benefits if:</text> <paragraph num="(a)"> <text>The individual:</text> <paragraph num="(i)"> <text>Meets all of the requirements under §A of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Is younger than 65 years old;</text> </paragraph> <paragraph num="(iii)"> <text>Was determined disabled by the Social Security Administration (SSA) but lost Social Security benefits solely due to employment;</text> </paragraph> <paragraph num="(iv)"> <text>Is entitled to enroll in Medicare Part A under §1818A of the Social Security Act; and</text> </paragraph> <paragraph num="(v)"> <text>Is not otherwise eligible for Medical Assistance under this chapter; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The assistance unit's net countable income does not exceed 200 percent of the federal poverty level for the number of persons in the assistance unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>SSA shall establish the effective date of QDWI coverage based on the:</text> <paragraph num="(a)"> <text>Individual's date of application for QDWI benefits;</text> </paragraph> <paragraph num="(b)"> <text>Date of potential QDWI eligibility, as specified in a letter from SSA to the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Dates of the next Medicare open enrollment period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medicare savings program benefits for a QDWI-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part A.</text> </paragraph> <paragraph num="(4)"> <text>Only the individual who is identified by SSA as potentially eligible may be eligible for QDWI benefits in a QDWI assistance unit.</text> </paragraph> <paragraph num="(5)"> <text>Retroactive coverage before the month of application is not available for QDWI benefits.</text> </paragraph> <paragraph num="(6)"> <text>If an individual delays in applying for QDWI benefits after notification of potential QDWI eligibility by SSA, the individual may be required by SSA to pay a premium surcharge for Medicare Part A, unless the individual is covered by an employer-based group health plan.</text> </paragraph> <paragraph num="(7)"> <text>Eligibility for QDWI benefits shall continue until the earliest of the following dates:</text> <paragraph num="(a)"> <text>The end of the month after the Department:</text> <paragraph num="(i)"> <text>Determines that the individual is no longer eligible for QDWI benefits in accordance with this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Sends the recipient a notice of termination at least 10 days before the effective date;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The end of the month before the month that the individual becomes:</text> <paragraph num="(i)"> <text>Re-entitled to premium-free Medicare Part A; or</text> </paragraph> <paragraph num="(ii)"> <text>65 years old;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The date of death; or</text> </paragraph> <paragraph num="(d)"> <text>The end of the month following the month that the individual:</text> <paragraph num="(i)"> <text>Is notified by SSA that the individual no longer has a disabling impairment; or</text> </paragraph> <paragraph num="(ii)"> <text>Files a request for termination of QDWI enrollment.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-4" heading="Medicare Buy-In Coverage for Medical Assistance Recipients."> <paragraph num="A."> <text>If a recipient, who is determined federally eligible and enrolled in Medical Assistance or the Maryland Children’s Health Program according to the requirements of this chapter or COMAR 10.09.11, is entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums, the Medical Assistance program shall provide the same coverage of Medicare savings program expenses as specified for a Qualified Medicare Beneficiary under Regulation .03-3E of this chapter.</text> </paragraph> <paragraph num="B."> <text>A qualified recipient is automatically made eligible by the Department or its designee for the Medicare buy-in benefits effective the first day of the:</text> <paragraph num="(1)"> <text>Second month after the month in which the individual is determined eligible for Medical Assistance or the first day of the third month of Medicare entitlement, whichever date is later, if the individual is eligible in a long-term care or spend down coverage group; or</text> </paragraph> <paragraph num="(2)"> <text>Month that the individual is eligible for both Medical Assistance and Medicare, if the individual is eligible under COMAR 10.09.24 or COMAR 10.09.11 for Medical Assistance in any coverage groups other than long-term care or spend down.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A recipient's eligibility for Medicare buy-in benefits shall continue until the recipient is determined ineligible.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application — General Requirements."> <paragraph num="A."> <text>The Department or its designee shall determine initial (retroactive and current) and continuing eligibility.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall give oral, written, or electronic information about the Medical Assistance Program such as:</text> <paragraph num="(1)"> <text>Requirements for eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Available services;</text> </paragraph> <paragraph num="(3)"> <text>An individual's rights and responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>Information in plain English, supported by translation services; and</text> </paragraph> <paragraph num="(5)"> <text>Information accessible to disabled individuals requesting an application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply.</text> </paragraph> <paragraph num="D."> <text>The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means and in a manner accessible to disabled individuals requesting an application.</text> </paragraph> <paragraph num="E."> <text>A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall:</text> <paragraph num="(1)"> <text>Demonstrate continued residency in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all nonfinancial and financial requirements in order to be determined eligible.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Application Filing and Signature Requirements.</text> <paragraph num="(1)"> <text>An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant shall be responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice.</text> </paragraph> <paragraph num="(2)"> <text>A signed application is required for all individuals for whom assistance is requested. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those individuals.</text> </paragraph> <paragraph num="(3)"> <text>An exception to §F(2) of this regulation is that a child born to a mother eligible for and receiving Medical Assistance on the date of the child's birth shall be considered to have applied for Medical Assistance and to have been found eligible for Medical Assistance on the date of his birth, and to remain eligible for Medical Assistance for a period of 1 year.</text> </paragraph> <paragraph num="(4)"> <text>A deemed newborn is eligible for receiving Medical Assistance if, at the time of birth, the child’s mother was covered by Medicaid in another state, as a child under CHIP, or under an 1115 waiver.</text> </paragraph> <paragraph num="(5)"> <text>For the purpose of establishing eligibility, the applicant or an authorized representative shall complete and sign the application.</text> </paragraph> <paragraph num="(6)"> <text>In the case of a child applicant younger than 18 years old, a parent of the child shall sign the application, except in the following situations:</text> <paragraph num="(a)"> <text>When the child does not live with a parent, or the parent with whom the child lives is an unmarried minor younger than 18 years old, the caretaker relative other than parent shall sign the application form;</text> </paragraph> <paragraph num="(b)"> <text>An authorized representative who is 18 years old or older shall complete and sign the application form for an unmarried child younger than 18 years old who is not living with a parent or caretaker relative other than the parent.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application; however, the application shall remain the property of the Department or its designee, and the withdrawal may not affect the requirements for establishing periods under consideration specified in §H of this regulation.</text> </paragraph> <paragraph num="H."> <text>Period under Consideration.</text> <paragraph num="(1)"> <text>The Department or its designee shall establish a current period under consideration based on the date of application established pursuant to §F(6) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The period under consideration shall be for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for Medical Assistance, except as specified in §H(3) and §N of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>For a deceased individual, the retroactive and current periods under consideration shall begin as stated in §H(1) and (2) of this regulation and may not extend beyond the month of death.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Processing Applications — Time Limitations.</text> <paragraph num="(1)"> <text>When a written, telephonic, or electronic application is filed, a decision shall be made promptly but not later than:</text> <paragraph num="(a)"> <text>10 days from the date of application when filed with the local health department; or</text> </paragraph> <paragraph num="(b)"> <text>30 days from the date of application when filed with the Department or its designee, with the exception of the local health department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The time standards specified in §I(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant.</text> </paragraph> <paragraph num="(3)"> <text>Information Required.</text> <paragraph num="(a)"> <text>The applicant shall report all required information. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> <paragraph num="(b)"> <text>The Department or its designee shall inform the applicant or authorized representative in a written or electronic notice of the required information and verifications needed to determine eligibility, and the applicable pending time limit.</text> </paragraph> <paragraph num="(c)"> <text>The applicant or authorized representative shall provide all information and requested verification for the determination of nonfinancial and financial eligibility, including information relating to health insurance coverage or potential third-party payments, early enough for the Department or its designee to meet time limitations.</text> </paragraph> <paragraph num="(d)"> <text>When an applicant completes the application form and requests coverage for:</text> <paragraph num="(i)"> <text>The current period, verification of all elements of eligibility may be required for the current period;</text> </paragraph> <paragraph num="(ii)"> <text>The retroactive period, verification of all elements of eligibility may be required for the retroactive period; or</text> </paragraph> <paragraph num="(iii)"> <text>Both the retroactive and current periods, verification of all elements of eligibility may be required for both the retroactive and current periods.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>When an applicant fails to complete the application form, or fails to provide the required information and verification to determine eligibility within the applicable time frame, the applicant shall be determined ineligible.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Extension of Time Standards.</text> <paragraph num="(a)"> <text>The time standards specified in §I(1) of this regulation shall be extended to allow the applicant sufficient time to complete provision of information when:</text> <paragraph num="(i)"> <text>The applicant is actively attempting to establish his eligibility but has been unable to provide the required information through no fault of his own; or</text> </paragraph> <paragraph num="(ii)"> <text>There is an administrative or other emergency beyond the control of the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Department or its designee shall document the reason for the delay in the applicant's written or electronic record. The extension of time will continue as long as the requirements of §I(4)(a) of this regulation are met. The Department or its designee shall deny Medical Assistance when these requirements cease to be met. When a subsequent application is made, eligibility and period under consideration shall be determined under §I(7), (8), (9), or (10) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The standards of promptness for acting on applications may not be used to deny assistance except as provided in §I(4)(b) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>The standards of promptness for acting on applications may not be used as a waiting period for granting assistance to eligible persons.</text> </paragraph> <paragraph num="(7)"> <text>Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration:</text> <paragraph num="(a)"> <text>Due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under §I(9) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>Solely because of excess income, the application shall be preserved for the period under consideration. The applicant may subsequently establish eligibility for the period under consideration under the “spend-down” process described under Regulations .09C(4) and .10D(5) of this chapter.</text> </paragraph> <paragraph num="(c)"> <text>Solely because of failure to complete the application requirements, including voluntary withdrawal of the application, the application shall be disposed of. If the applicant reapplies, the process and period under consideration shall be established under §I (8), (9), or (10) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors or Excess Income.</text> <paragraph num="(a)"> <text>A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors or excess income shall be considered a reactivation of the appropriate earlier application.</text> </paragraph> <paragraph num="(b)"> <text>The reactivation period shall:</text> <paragraph num="(i)"> <text>Apply to the earliest rejected application for which the period under consideration has not expired;</text> </paragraph> <paragraph num="(ii)"> <text>Include the retroactive period associated with the current period.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Reapplication Following a Decision of Ineligibility Due to a Nonfinancial Factor.</text> <paragraph num="(a)"> <text>When an applicant reapplies following a decision of ineligibility due to a nonfinancial factor, a new period under consideration shall be established based on the date a new application is submitted. Coverage may not be provided for any month in which the applicant has not overcome the prior factor of ineligibility.</text> </paragraph> <paragraph num="(b)"> <text>The incurred medical expenses from a past period during which nonfinancial ineligibility or excess resources existed may be applied to excess income, if any, for the current period.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Reapplication After the Period Under Consideration Has Expired.</text> <paragraph num="(a)"> <text>A request for eligibility and application filed after the expiration of the period under consideration shall be considered a new application, and a new period under consideration shall be established.</text> </paragraph> <paragraph num="(b)"> <text>A part of the expired current period under consideration may not be converted to a retroactive period for purposes of determining eligibility. A part of the expired current period under consideration may constitute part or all of the 3 months before the month of application for purposes of post-eligibility deductions.</text> </paragraph> <paragraph num="(c)"> <text>The incurred unpaid expenses from the expired period may, with the written consent of the applicant, be applied to excess income, if any, for the current period.</text> </paragraph> <paragraph num="(d)"> <text>The written consent shall be obtained on a form designated by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>An applicant or recipient may be assisted by an individual or individuals of the applicant's or recipient's choice in the application process and may be accompanied by this individual or individuals when in contact with the Department or its designee.</text> </paragraph> <paragraph num="K."> <text>Required Application for Income Benefits.</text> <paragraph num="(1)"> <text>Applicants and recipients shall apply for all income benefits to which there may be entitlement, except as specified in §K(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Income benefits include, but are not limited to, Social Security, Unemployment Compensation, Railroad Retirement, Veterans' Administration, Civil Service annuities, federal, state, or local government and private pensions, and Workers' Compensation.</text> </paragraph> <paragraph num="(3)"> <text>Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant's or recipient's physical or mental condition and for whom there is no other individual to perform the activity are not required to apply for income benefits.</text> </paragraph> <paragraph num="(4)"> <text>Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits.</text> </paragraph> <paragraph num="(5)"> <text>At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant's or recipient's documented reasonable and continuous efforts to establish entitlement to income benefits.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Social Security Number.</text> <paragraph num="(1)"> <text>Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for any individual whose income is considered in determining financial eligibility.</text> </paragraph> <paragraph num="(2)"> <text>Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant or recipient complies with §L(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an applicant or recipient is physically or mentally incapable of acting for himself or herself or lacks the resources to meet the requirements, the Department or its designee shall assist the applicant or recipient in obtaining the necessary evidentiary documents required for application for a Social Security number, and any costs incurred by the Department or its designee shall be paid out of administrative funds.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Third-Party Liability.</text> <paragraph num="(1)"> <text>Applicants and recipients shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for their medical expenses.</text> </paragraph> <paragraph num="(2)"> <text>Applicants and recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments.</text> </paragraph> <paragraph num="(3)"> <text>In accident situations, applicants and recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Retroactive Eligibility for Applicants or Recipients. An applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established in accordance with the requirements of Regulation .09B of this chapter.</text> </paragraph> <paragraph num="O."> <text>The Department or its designee shall explain the spend-down provision to an applicant determined ineligible because of excess income.</text> </paragraph> <paragraph num="P."> <text>The Department or its designee shall maintain a written or electronic record including documentation of all required elements of eligibility.</text> </paragraph> <paragraph num="Q."> <text>The Department or its designee shall restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the Program, including:</text> <paragraph num="(1)"> <text>Establishing eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Determining the extent of coverage under the Program;</text> </paragraph> <paragraph num="(3)"> <text>Providing services for recipients; and</text> </paragraph> <paragraph num="(4)"> <text>Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Program.</text> </paragraph> </paragraph> <paragraph num="R."> <text>The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each of the following applicants or recipients of Medical Assistance:</text> <paragraph num="(1)"> <text>Childless, adults older than 19 years old and younger than 65 years old;</text> </paragraph> <paragraph num="(2)"> <text>Parents and other Caretaker Relatives;</text> </paragraph> <paragraph num="(3)"> <text>Pregnant and postpartum women;</text> </paragraph> <paragraph num="(4)"> <text>Children younger than 21 years old; and</text> </paragraph> <paragraph num="(5)"> <text>Former Foster Care Children younger than 26 years old.</text> </paragraph> </paragraph> <paragraph num="S."> <text>An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Specific Application Requirements for MAGI Exempt Coverage Groups."> <paragraph num="A."> <text>All of the requirements of Regulation .04 of this chapter shall apply with the exceptions stated in this chapter.</text> </paragraph> <paragraph num="B."> <text>Application Filing and Signature Requirements.</text> <paragraph num="(1)"> <text>An individual who wishes to apply for Medical Assistance shall submit a signed application to the Department or its designee in the jurisdiction where his residence is located.</text> </paragraph> <paragraph num="(2)"> <text>A deemed newborn is eligible for receiving Medical Assistance if at the time of birth the child’s mother was covered in another state as a child under CHIP or under a 1115 waiver.</text> </paragraph> <paragraph num="(3)"> <text>An individual who has filed an application may voluntarily withdraw that application; but the withdrawal may not affect the requirements for the penalty period associated with the transfer of a resource specified under Regulation .08I of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Period Under Consideration. Current eligibility shall have a period of consideration of a 6-month period beginning with the month of application for Medical Assistance, except as specified in Regulation .04H(3) of this chapter.</text> </paragraph> <paragraph num="D."> <text>Processing Applications. When a written or electronic application is filed, a decision shall be made promptly but not later than:</text> <paragraph num="(1)"> <text>45 days from the date of application in the case of determination of aged and blind individuals; or</text> </paragraph> <paragraph num="(2)"> <text>60 days from the date of application in the case of determination of disability.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Extension of Time Standards.</text> <paragraph num="(1)"> <text>The time standards specified in Regulation .04I(1) of this chapter shall be extended to allow the applicant sufficient time to complete provision of information when the examining physician delays or fails to take a required action.</text> </paragraph> <paragraph num="(2)"> <text>Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors, Excess Resources, or Excess Income.</text> <paragraph num="(a)"> <text>A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors, excess resources, or excess income shall be considered a reactivation of the appropriate earlier application.</text> </paragraph> <paragraph num="(b)"> <text>The reactivation period shall:</text> <paragraph num="(i)"> <text>Apply to the earliest rejected application for which the period under consideration has not expired; and</text> </paragraph> <paragraph num="(ii)"> <text>Include the retroactive period associated with the current period.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor or excess resources, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under Regulation .04I(9) of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Interview.</text> <paragraph num="(1)"> <text>A face-to-face interview may be conducted at the request of the applicant or the Department or its designee.</text> </paragraph> <paragraph num="(2)"> <text>If it is determined that a face-to-face interview is necessary, the interview may be conducted with an individual other than the applicant in the following situations:</text> <paragraph num="(a)"> <text>When the Department or its designee determines that the applicant cannot participate in the interview because of unusual circumstances such as severely incapacitating disabilities, the interview shall be conducted with an authorized representative or individual acting responsibly on behalf of the applicant; or</text> </paragraph> <paragraph num="(b)"> <text>When the applicant is an unmarried child younger than 18 years old and is not living with a parent or other caretaker relative, the interview shall be conducted with one or more of the following individuals who is 18 years old or older:</text> <paragraph num="(i)"> <text>The parent or other knowledgeable relative of the child;</text> </paragraph> <paragraph num="(ii)"> <text>The nonrelated individual with whom the child is living; or</text> </paragraph> <paragraph num="(iii)"> <text>Another designated responsible individual who is knowledgeable about the child's circumstances.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Required Application for Income Benefits.</text> <paragraph num="(1)"> <text>Eligibility may not be established until applicants, and recipients furnish proof that they have applied for and taken all other necessary steps to obtain and accept all income benefits to which there may be entitlement, except as specified in §N(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Income benefits include, but are not limited to:</text> <paragraph num="(a)"> <text>Social Security;</text> </paragraph> <paragraph num="(b)"> <text>Unemployment Compensation;</text> </paragraph> <paragraph num="(c)"> <text>Railroad Retirement;</text> </paragraph> <paragraph num="(d)"> <text>Veterans’ Administration;</text> </paragraph> <paragraph num="(e)"> <text>Civil Service annuities;</text> </paragraph> <paragraph num="(f)"> <text>Federal, state, or local government and private pensions; and</text> </paragraph> <paragraph num="(g)"> <text>Workers’ Compensation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant’s or recipient’s physical or mental condition and for whom there is no other individuals to perform the activity are not required to apply for income benefits.</text> </paragraph> <paragraph num="(4)"> <text>Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits.</text> </paragraph> <paragraph num="(5)"> <text>At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant’s or recipient’s documented reasonable and continuous efforts to establish entitlement to income benefits.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An applicant who is 65 years old or older, or blind or disabled, is not eligible until the applicant furnishes proof that the applicant has applied for or is receiving Part A Medicare. Eligibility determination may not be delayed pending the results of the application filed for Part A Medicare. Periodic reviews of eligibility are necessary for those blind or disabled individuals initially determined ineligible for Medicare because of the required waiting period.</text> </paragraph> <paragraph num="I."> <text>Social Security Number.</text> <paragraph num="(1)"> <text>Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for each member of an assistance unit and any individual whose income and resources are considered in determining the financial eligibility of an assistance unit.</text> </paragraph> <paragraph num="(2)"> <text>An individual may not be added to an assistance unit until an application is completed for a Social Security number.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Retroactive Eligibility for Cash Assistance Applicants or Recipients. A Public Assistance applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established as follows:</text> <paragraph num="(1)"> <text>The Medical Assistance application date shall be the:</text> <paragraph num="(a)"> <text>Same as that of the Public Assistance application date if the Medical Assistance application is filed within 3 months of the date of the Public Assistance application; or</text> </paragraph> <paragraph num="(b)"> <text>Date the Medical Assistance application is filed if the filing date is more than 3 months after the date of the Public Assistance application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Retroactive eligibility shall be determined in accordance with the requirements of Regulation .10C of this chapter.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for an Aged Blind Disabled applicants or recipients that:</text> <paragraph num="(1)"> <text>Resides in a long term care facility; or</text> </paragraph> <paragraph num="(2)"> <text>Is chronically ill and non-ambulatory.</text> </paragraph> </paragraph> <paragraph num="L."> <text>An applicant shall sign consent forms as needed authorizing the Department or its designee to verify from sources such as an employer, banks, and public or private agencies, information needed to establish eligibility.</text> </paragraph> <paragraph num="M."> <text>Obtaining Financial Records from Fiduciary Institutions Doing Business in the State as of October 1, 2017.</text> <paragraph num="(1)"> <text>The Department or its designee shall inform the applicant or authorized representative in a written or electronic document of the required information and verifications needed to determine financial eligibility for Medical Assistance and the time limit for submitting the required records.</text> </paragraph> <paragraph num="(2)"> <text>The applicant or authorized representative shall provide all of the required information and verifications needed to determine financial eligibility for Medical Assistance within the time period specified in the notice from the Department or its designee.</text> </paragraph> <paragraph num="(3)"> <text>The Department or its designee shall request financial records necessary to determine the applicant’s eligibility for Medical Assistance on behalf of the applicant when:</text> <paragraph num="(a)"> <text>The applicant or authorized representative is actively attempting to obtain financial documentation to establish eligibility but has been unable to provide the required financial information through no fault of his own from a certain fiduciary institution conducting business in the State;</text> </paragraph> <paragraph num="(b)"> <text>The applicant or authorized representative provides documentation to show their efforts to obtain the information; and</text> </paragraph> <paragraph num="(c)"> <text>The applicant or authorized representative provides a signed consent form designated by the Department or its designee to obtain the records.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the conditions set forth in §M(3) of this regulation are not met, the applicant or authorized representative remains responsible to provide the information.</text> </paragraph> <paragraph num="(5)"> <text>Reimbursement Schedule. The Department or its designee shall reimburse a fiduciary institution for providing copies of financial records in accordance with the Banks and Banking regulations found in 12 CFR §219.3, including the Reimbursement Schedule at Appendix A.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Nonfinancial Eligibility Requirements — Citizenship."> <paragraph num="A."> <text>Eligibility. To be eligible for federal coverage of full Medical Assistance benefits, an individual shall be:</text> <paragraph num="(1)"> <text>A citizen of the United States, including:</text> <paragraph num="(a)"> <text>An individual who was born in:</text> <paragraph num="(i)"> <text>One of the 50 states;</text> </paragraph> <paragraph num="(ii)"> <text>The District of Columbia;</text> </paragraph> <paragraph num="(iii)"> <text>Puerto Rico;</text> </paragraph> <paragraph num="(iv)"> <text>Guam;</text> </paragraph> <paragraph num="(v)"> <text>The Northern Mariana Islands; or</text> </paragraph> <paragraph num="(vi)"> <text>The Virgin Islands;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A child born outside of the United States if:</text> <paragraph num="(i)"> <text>The federal requirements, including the requirements in the Child Citizenship Act of 2000 (Public Law 106-395), are met for the child to automatically acquire United States citizenship upon the child's lawful admission to the United States for permanent residence;</text> </paragraph> <paragraph num="(ii)"> <text>At least one of the child's natural, adoptive, or stepparents is a United States citizen by birth or naturalization;</text> </paragraph> <paragraph num="(iii)"> <text>The child is younger than 18 years old;</text> </paragraph> <paragraph num="(iv)"> <text>The child is residing in the United States in the legal and physical custody of the citizen or naturalized parent; and</text> </paragraph> <paragraph num="(v)"> <text>The child is a lawful permanent resident of the United States;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An individual who has been naturalized as a United States citizen; or</text> </paragraph> <paragraph num="(d)"> <text>A national from American Samoa or Swain's Island;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A qualified alien, as specified in §C of this regulation, who is eligible in accordance with the requirements related to the 5-year bar specified at §D of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>An honorably discharged veteran of the armed forces of the United States;</text> </paragraph> <paragraph num="(4)"> <text>An alien on active duty in the armed forces of the United States;</text> </paragraph> <paragraph num="(5)"> <text>The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an:</text> <paragraph num="(a)"> <text>Honorably discharged veteran of the armed forces of the United States; or</text> </paragraph> <paragraph num="(b)"> <text>Alien on active duty in the armed forces of the United States; or</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An alien who is:</text> <paragraph num="(a)"> <text>Eligible for and receiving Supplemental Security Income (SSI);</text> </paragraph> <paragraph num="(b)"> <text>A member of a state or federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or</text> </paragraph> <paragraph num="(c)"> <text>An American Indian born in Canada to whom §289 of the Immigration and Nationality Act (INA) applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Veterans. Veterans of the following foreign armed forces are considered under this regulation to be veterans of the armed forces of the United States:</text> <paragraph num="(1)"> <text>Individuals who served in the Philippine Commonwealth Army during World War II or as Philippine scouts following World War II; and</text> </paragraph> <paragraph num="(2)"> <text>Hmong and other Highland Lao veterans who fought under United States' command during the Vietnam War and who were lawfully admitted to the United States for permanent residence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Qualified Aliens. According to §431 of the Personal Responsibility and Work Opportunity and Reconciliation Act of 1996 (PRWORA), qualified aliens admitted to the United States shall include:</text> <paragraph num="(1)"> <text>The following types of aliens, who may be subject to the 5-year bar specified at §D of this regulation, depending on their most recent date of entry and their date of qualified alien status:</text> <paragraph num="(a)"> <text>Aliens who were lawfully admitted to the United States for permanent residence or who since admission were granted lawful permanent resident status in accordance with the INA;</text> </paragraph> <paragraph num="(b)"> <text>Aliens granted parole for at least 1 year under §212(d)(5) of the INA; and</text> </paragraph> <paragraph num="(c)"> <text>A documented or undocumented immigrant who was battered or subjected to extreme cruelty by the individual's United States citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the immigrant, if:</text> <paragraph num="(i)"> <text>The spouse or parent consented to, or acquiesced in, the battery or cruelty;</text> </paragraph> <paragraph num="(ii)"> <text>The abusive act or acts occurred in the United States;</text> </paragraph> <paragraph num="(iii)"> <text>The individual responsible for the battery or cruelty no longer lives in the same household as the victim;</text> </paragraph> <paragraph num="(iv)"> <text>A Violence Against Women Act immigration case or a family-based visa petition has been filed; and</text> </paragraph> <paragraph num="(v)"> <text>There is a substantial connection between the battery or cruelty and the need for Medical Assistance benefits; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following types of aliens, who are not subject to the 5-year bar specified in §D of this regulation:</text> <paragraph num="(a)"> <text>Alien children and pregnant women who are lawfully residing in the United States, including legal permanent residents who have resided in the United States for less than 5 years as described under §214 of the Children's Health Insurance Program Authorization Act of 2009 (CHIPRA);</text> </paragraph> <paragraph num="(b)"> <text>Aliens who were lawfully admitted to the United States for permanent residence as Amerasian immigrants under §584 of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1988;</text> </paragraph> <paragraph num="(c)"> <text>Refugees admitted under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Aliens granted asylum under §208 of the INA;</text> </paragraph> <paragraph num="(e)"> <text>Aliens whose deportation is being withheld under:</text> <paragraph num="(i)"> <text>§243(h) of the INA as in effect prior to April 1, 1997; or</text> </paragraph> <paragraph num="(ii)"> <text>§241(b)(3) of the INA, as amended;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Cuban or Haitian entrants, as defined at §501(e) of the Refugee Education Assistance Act of 1980;</text> </paragraph> <paragraph num="(g)"> <text>Aliens granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980;</text> </paragraph> <paragraph num="(h)"> <text>Children receiving federal payments for foster care or adoption assistance under Part B or E of Title IV of the Social Security Act, if the child's foster or adoptive parent is considered a citizen or qualified alien; and</text> </paragraph> <paragraph num="(i)"> <text>Victims of a severe form of trafficking, in accordance with §107(b)(1) of the Trafficking Victims Protection Act of 2000, who have been subjected to:</text> <paragraph num="(i)"> <text>Sex trafficking if the act is induced by force, fraud, or coercion, or the individual who was induced to perform the act was younger than 18 years old on the date that the visa application was filed; or</text> </paragraph> <paragraph num="(ii)"> <text>Involuntary servitude.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Five-Year Bar to Federal Medical Assistance for Qualified Aliens.</text> <paragraph num="(1)"> <text>Except for coverage of emergency medical services specified at Regulation .05-2 of this chapter, qualified aliens in the categories specified in §C(1) of this regulation who entered the United States on or after August 22, 1996, were not eligible for federally-funded Medical Assistance for 5 years from the date that the qualified alien:</text> <paragraph num="(a)"> <text>Entered the United States with the status of a qualified alien; or</text> </paragraph> <paragraph num="(b)"> <text>Obtained the status of a qualified alien, if the individual did not enter the United States as a qualified alien.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The 5-year bar specified in §D(1) of this regulation shall also be applied to qualified aliens who entered the United States before August 22, 1996, but did not remain continuously present in the United States from the last date of entry before August 22, 1996 until the date of qualified alien status.</text> </paragraph> <paragraph num="(3)"> <text>An alien is not considered to be continuously present in the United States as specified in §D(2) of this regulation if, before the date of qualified alien status, the alien had:</text> <paragraph num="(a)"> <text>A single absence from the United States of more than 30 days; or</text> </paragraph> <paragraph num="(b)"> <text>Absences from the United States totaling more than 90 days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The 5-year bar to eligibility for federal Medical Assistance benefits, specified in §D(1) of this regulation, does not apply to:</text> <paragraph num="(a)"> <text>Qualified aliens in the categories specified at:</text> <paragraph num="(i)"> <text>§C(1) of this regulation, who are not subject to the 5-year bar in accordance with §D(1) or (2) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>§C(2) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A qualified alien who is:</text> <paragraph num="(i)"> <text>An honorably discharged veteran of the armed forces of the United States;</text> </paragraph> <paragraph num="(ii)"> <text>On active duty in the armed forces of the United States; or</text> </paragraph> <paragraph num="(iii)"> <text>The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an honorably discharged veteran or individual on active duty in the armed forces of the United States; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Lawful permanent residents who:</text> <paragraph num="(i)"> <text>Entered the United States under another exempt category specified at §D(4)(a)—(b) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Converted to lawful permanent resident status.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Effective December 1, 2009, as authorized by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), the 5-year bar will no longer apply to Medical Assistance or Children's Health Insurance Program eligibility for pregnant women and children who are qualified aliens.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Documentation of Citizenship and Identity."> <paragraph num="A."> <text>An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is:</text> <paragraph num="(1)"> <text>Declared to be a citizen or national of the United States; and</text> </paragraph> <paragraph num="(2)"> <text>Being determined for:</text> <paragraph num="(a)"> <text>Initial eligibility based on an application filed on or after September 1, 2006; or</text> </paragraph> <paragraph num="(b)"> <text>Continuing eligibility based on a redetermination with an end date on or after September 30, 2006.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The requirements of this regulation shall be met for all Medical Assistance coverage groups except for:</text> <paragraph num="(1)"> <text>Supplemental Security Income beneficiaries;</text> </paragraph> <paragraph num="(2)"> <text>Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of Regulation .05-2 of this chapter who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth;</text> </paragraph> <paragraph num="(4)"> <text>Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare;</text> </paragraph> <paragraph num="(5)"> <text>Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Act, based on the individual's disability;</text> </paragraph> <paragraph num="(6)"> <text>Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and</text> </paragraph> <paragraph num="(7)"> <text>Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant may not be determined eligible for Medical Assistance until the requirements of this regulation are met.</text> </paragraph> <paragraph num="D."> <text>An applicant may be determined eligible for Medical Assistance for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible.</text> </paragraph> <paragraph num="E."> <text>Continuing eligibility for a recipient may not be approved at redetermination until the requirements of this regulation are met.</text> </paragraph> <paragraph num="F."> <text>If an applicant or recipient fails to meet the requirements of this regulation within the time standards specified at Regulation .04I(1) of this chapter, and the time standards are not extended in accordance with Regulation .04I(4) of this chapter, the Department shall:</text> <paragraph num="(1)"> <text>Deny eligibility for an applicant; or</text> </paragraph> <paragraph num="(2)"> <text>Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The reactivation requirements in Regulation .04I(8) of this chapter shall apply to applicants and recipients deemed MAGI exempt. The documentation requirements of this regulation are subsequently met within the current period under consideration for the:</text> <paragraph num="(1)"> <text>Applicant's denied application; or</text> </paragraph> <paragraph num="(2)"> <text>Recipient's terminated period of continuing eligibility.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If there is documentation in an applicant's or recipient's written or electronic record or a state or federal data system that demonstrates that the individual meets the requirements of this regulation, the individual shall be considered to meet the requirements of this regulation, unless the:</text> <paragraph num="(1)"> <text>Department or its designee has cause to question the documentation previously accepted; or</text> </paragraph> <paragraph num="(2)"> <text>Federal government requires additional documentation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-2" heading="Nonfinancial Eligibility Requirements — Emergency Medical Services for Ineligible or Illegal Aliens."> <paragraph num="A."> <text>An alien shall be eligible for federal Medical Assistance coverage of emergency medical services, as specified under §§B and C of this regulation, if the alien is determined by the Department to:</text> <paragraph num="(1)"> <text>Have received emergency medical services described under §§B and C of this regulation that are necessary for treatment of an emergency medical condition; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all other requirements of Medical Assistance eligibility as specified in this chapter, including Maryland residency and financial eligibility, except the requirements related to:</text> <paragraph num="(a)"> <text>Social Security number; and</text> </paragraph> <paragraph num="(b)"> <text>Alien eligibility and declaration of immigration status.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency medical services, including labor and delivery services, are for the treatment of an emergency medical condition that, after a sudden onset, manifests itself by acute symptoms of sufficient severity, including severe pain, such that the absence of immediate medical attention can reasonably be expected to result in:</text> <paragraph num="(1)"> <text>Placing the individual's health in serious jeopardy;</text> </paragraph> <paragraph num="(2)"> <text>Serious impairment to bodily functions; or</text> </paragraph> <paragraph num="(3)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency medical services extend from when the individual enters a hospital to receive the emergency medical services until the individual's emergency medical condition or other medical condition requiring the emergency medical services is stabilized, as determined by the Department.</text> </paragraph> <paragraph num="D."> <text>Emergency medical services do not include:</text> <paragraph num="(1)"> <text>An organ transplant and all services related to an organ transplant; or</text> </paragraph> <paragraph num="(2)"> <text>Routine prenatal or postpartum care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-3" heading="Nonfinancial Eligibility Requirements — Residency."> <paragraph num="A."> <text>To be eligible for the Maryland Medical Assistance Program, an applicant or recipient shall be a Maryland resident.</text> </paragraph> <paragraph num="B."> <text>An individual is a Maryland resident if the individual resides in Maryland with the intent of remaining permanently or for an indefinite period, regardless of whether the individual maintains the residence permanently or at a fixed address.</text> </paragraph> <paragraph num="C."> <text>Residency in a state begins on the day that an individual:</text> <paragraph num="(1)"> <text>Enters the state with the intent to remain permanently or for an indefinite period; or</text> </paragraph> <paragraph num="(2)"> <text>Decides to remain in the state permanently or for an indefinite period after entering for another purpose.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual is not a resident of a state if the individual:</text> <paragraph num="(1)"> <text>Is temporarily residing in or visiting the state without the intent of remaining, except as specified under §I(2)(b)(ii) or §I(3) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Came into the state for a specific, time-limited purpose and does not intend to remain, except as specified under §I(2)(b)(ii) or §I(3) of this regulation; or</text> </paragraph> <paragraph num="(3)"> <text>Entered the state voluntarily to obtain noninstitutional medical care, such as for acute hospital inpatient services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Residency in a state established on any day in a calendar month shall constitute residency for the full month.</text> </paragraph> <paragraph num="F."> <text>Retaining Residency.</text> <paragraph num="(1)"> <text>Residency is retained until abandoned.</text> </paragraph> <paragraph num="(2)"> <text>Temporary absence from a state, with the intent to return to the state when the purpose of the absence is accomplished, does not interrupt continuity of residency, unless another state's Medical Assistance program determines that the individual is a resident of the other state.</text> </paragraph> <paragraph num="(3)"> <text>An individual who is routinely absent from a state for a protracted period of time retains residency in that state if the individual:</text> <paragraph num="(a)"> <text>Declares the intent to remain a resident of the state;</text> </paragraph> <paragraph num="(b)"> <text>Has an established residential address in the state; and</text> </paragraph> <paragraph num="(c)"> <text>Is not certified for Medical Assistance or receiving public assistance in another state.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Residency in a state is not affected by an absence for:</text> <paragraph num="(a)"> <text>Unanticipated medical care; or</text> </paragraph> <paragraph num="(b)"> <text>Out-of-state medical treatment preauthorized by the state's Medical Assistance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An individual is ineligible for a state's Medical Assistance Program for any month in which the individual is not a resident of the state.</text> </paragraph> <paragraph num="H."> <text>State Supplementary Payment for a Recipient of Supplemental Security Income (SSI).</text> <paragraph num="(1)"> <text>Notwithstanding any other provisions of this regulation, the state of residence for a recipient of a state supplementary SSI payment is the state making the supplementary payment.</text> </paragraph> <paragraph num="(2)"> <text>An individual receiving a state supplementary payment from another state who moves to Maryland with the intent of remaining in Maryland is not eligible for Maryland Medical Assistance until:</text> <paragraph num="(a)"> <text>The individual's change of state residence is verified; and</text> </paragraph> <paragraph num="(b)"> <text>Changes, if any, in the individual's payment amount are made with the Social Security Administration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Additional Residency Criteria for Noninstitutionalized Individuals.</text> <paragraph num="(1)"> <text>Noninstitutionalized Child.</text> <paragraph num="(a)"> <text>Except as otherwise specified in this regulation, a noninstitutionalized, unmarried individual younger than 21 years old is considered a resident of the state where the child lives:</text> <paragraph num="(i)"> <text>With the child's parent or other caretaker relative; or</text> </paragraph> <paragraph num="(ii)"> <text>In another living arrangement if the child is not living with the child's parent or other caretaker relative, and the child's parent or other caretaker relative is not responsible for the child's day-to-day care and supervision.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a child receiving federal payments for foster care or adoption assistance under Title IV-E of the Social Security Act, the child's state of residence is the state where the child lives, even if it is not the state making the payments.</text> </paragraph> <paragraph num="(c)"> <text>If a noninstitutionalized child's Medical Assistance eligibility is determined based on blindness or disability, the child's state of residence is the state where the child lives.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Noninstitutionalized Adult. A noninstitutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, is considered a resident of the state where the individual lives:</text> <paragraph num="(a)"> <text>Voluntarily with the intent to remain permanently or for an indefinite period; or</text> </paragraph> <paragraph num="(b)"> <text>At the time of Medical Assistance application, if the individual is:</text> <paragraph num="(i)"> <text>Determined as incapable of indicating intent, in accordance with §K of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>Not receiving assistance from another state and entered the state with a job commitment or seeking employment, whether or not the individual is currently employed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The exclusion of Medical Assistance eligibility under §D of this regulation for individuals who temporarily reside in the state without the intent of remaining shall be waived for members of an assistance unit that includes a migrant worker, in MAGI Exempt coverage groups.</text> </paragraph> <paragraph num="(4)"> <text>Notwithstanding any other provision of this regulation, the state of residence for an individual placed by a state government in another state is the state that arranges or makes the placement for medical or other publicly funded services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Additional Residency Criteria for Institutionalized Individuals.</text> <paragraph num="(1)"> <text>For an institutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, the state of residence is the state where the individual is institutionalized, if the individual indicates the intent to remain in the long-term care facility indefinitely.</text> </paragraph> <paragraph num="(2)"> <text>If an institutionalized adult became incapable of indicating intent when the individual was 21 years old or older, the individual's state of residence is the state where the individual is institutionalized.</text> </paragraph> <paragraph num="(3)"> <text>An institutionalized child younger than 21 years old, or an institutionalized adult who became incapable of indicating intent when younger than 21 years old, is a resident of the state in which the:</text> <paragraph num="(a)"> <text>Individual's parent or other legal guardian resided at the time of the individual's placement in the long-term care facility;</text> </paragraph> <paragraph num="(b)"> <text>Individual's parent or other legal guardian currently resides, who applied for Medical Assistance on the individual's behalf; or</text> </paragraph> <paragraph num="(c)"> <text>Individual is institutionalized if the individual was abandoned by the individual's parents and does not yet have a legal guardian.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Notwithstanding any other provision of this regulation, the state of residence for an individual institutionalized by a state government in an out-of-state facility is the state that arranges or makes the placement.</text> </paragraph> <paragraph num="(5)"> <text>The Department may not deny Medical Assistance eligibility to an institutionalized individual who satisfies the residency requirements of this regulation, on the grounds that the individual did not establish Maryland residency before entering the long-term care facility.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An adult is considered incapable of indicating intent if the individual:</text> <paragraph num="(1)"> <text>Has an Intelligence Quotient of 49 or less, or a mental age of 7 years old or younger, based on tests acceptable to the Department's Developmental Disabilities Administration;</text> </paragraph> <paragraph num="(2)"> <text>Is judged legally incompetent; or</text> </paragraph> <paragraph num="(3)"> <text>Is found incapable of indicating intent based on medical documentation obtained from a physician, psychologist, or other person licensed by the state in the field of intellectual disabilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-4" heading="Nonfinancial Criteria for MAGI Exempt Coverage Groups."> <paragraph num="A."> <text>Blindness.</text> <paragraph num="(1)"> <text>To be eligible for Medical Assistance as a blind individual, an applicant or a recipient shall be blind as defined at Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Procedure for Determination of Blindness.</text> <paragraph num="(a)"> <text>If an applicant's or recipient's eligibility for Medical Assistance is determined on the basis of blindness, an ophthalmologist or a licensed optometrist shall examine the individual, unless:</text> <paragraph num="(i)"> <text>Both of the individual's eyes are missing; or</text> </paragraph> <paragraph num="(ii)"> <text>The Social Security Administration has determined that the individual is currently blind.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The ophthalmologist or licensed optometrist shall submit a report of the examination to the local department of social services or other entity designated by the Department.</text> </paragraph> <paragraph num="(c)"> <text>An ophthalmologist, contracted by the Department or its designee, shall review the report and determine, on behalf of the local department of social services or other entity designated by the Department:</text> <paragraph num="(i)"> <text>Whether the individual meets the definition of blindness; and</text> </paragraph> <paragraph num="(ii)"> <text>The need and frequency of reexamination for periodic redetermination of blindness.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reexaminations for periodic redeterminations of blindness shall be conducted according to the procedures described under §B(2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>The local department of social services or other entity designated by the Department shall accept the Social Security Administration's determination of blindness for an individual receiving a Social Security benefit based on blindness.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disability.</text> <paragraph num="(1)"> <text>In order to be eligible for Medical Assistance as a disabled individual, an applicant or recipient shall meet the definition of disabled in Regulation .02B of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Procedure for Determination of Disability.</text> <paragraph num="(a)"> <text>The Family Investment Administration shall determine disability.</text> </paragraph> <paragraph num="(b)"> <text>The local department of social services shall obtain a medical report and other nonmedical evidence for an individual applying for Medical Assistance on the basis of disability. The medical report and nonmedical evidence shall include a diagnosis and other information in accordance with the requirements for evidence applicable to disability determinations under the Supplemental Security Income Program (SSI), specified under 20 CFR Part 416, Subpart I.</text> </paragraph> <paragraph num="(c)"> <text>A Family Investment Administration review team shall review the medical report and other evidence obtained under §B(2)(b) of this regulation and determine whether the individual’s condition meets the definition of disability. The review team shall be composed of a medical or psychological consultant, and another individual who is qualified to interpret and evaluate medical reports and other evidence relating to the individual’s physical or mental impairments and, as necessary, to determine the capacities of the individual to perform substantial gainful activity as specified in 20 CFR Part 416, Subpart J.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Disability Determination Made by the Social Security Administration.</text> <paragraph num="(a)"> <text>The Family Investment Administration may not make an independent determination of disability if the Social Security Administration has made a disability determination within 90 days of the date of the Medical Assistance application on the same issues presented in the Medical Assistance application.</text> </paragraph> <paragraph num="(b)"> <text>A determination by the Social Security Administration is binding on the Family Investment Administration until it is changed by the Social Security Administration. If the Social Security Administration determination is changed, the new determination is binding on the Family Investment Administration.</text> </paragraph> <paragraph num="(c)"> <text>The Department or its designee shall refer to the Social Security Administration for reconsideration or reopening of the determination all applicants who allege new information or evidence affecting previous Social Security Administration determinations of ineligibility based on disability, except as specified in §B(4)(d)(i) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Disability Determination made by the Family Investment Administration. The Family Investment Administration shall make a determination of disability if any of the following circumstances exists:</text> <paragraph num="(a)"> <text>The individual applies for Medical Assistance and has not applied for SSI benefits;</text> </paragraph> <paragraph num="(b)"> <text>The individual applied for SSI benefits and was found ineligible for a reason other than disability;</text> </paragraph> <paragraph num="(c)"> <text>The individual has applied for both Medical Assistance and SSI benefits, and the Social Security Administration has not made an SSI determination within 90 days from the date of the individual’s application for Medical Assistance;</text> </paragraph> <paragraph num="(d)"> <text>The individual has applied for Medical Assistance and:</text> <paragraph num="(i)"> <text>Alleges a disabling condition different from, or in addition to, that considered by the Social Security Administration in making its determinations;</text> </paragraph> <paragraph num="(ii)"> <text>Alleges more than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated since that determination and alleges a new period of disability that meets the durational requirements for disability, and has not applied to the Social Security Administration for a determination with respect to those allegations;</text> </paragraph> <paragraph num="(iii)"> <text>Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated and alleges a new period of disability that meets the durational requirements for disability, and has applied to the Social Security Administration for reconsideration or reopening of its disability decision but the Social Security Administration has refused to consider the new allegations; or</text> </paragraph> <paragraph num="(iv)"> <text>Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated, alleges a new period of disability that meets the durational requirements for disability, and no longer meets the nondisability requirements for SSI, but may meet the State’s nondisability requirements for Medical Assistance eligibility.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-5" heading="Nonfinancial Eligibility Requirements — Institutions."> <paragraph num="A."> <text>Inmate of a Public Institution.</text> <paragraph num="(1)"> <text>To be eligible for Medical Assistance, an applicant or recipient may not be incarcerated as an inmate of a public institution.</text> </paragraph> <paragraph num="(2)"> <text>Inmate Status.</text> <paragraph num="(a)"> <text>An individual is considered incarcerated as an inmate of a public institution if the individual resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status awaiting criminal proceedings, penal dispositioning, or other involuntary detainment procedure.</text> </paragraph> <paragraph num="(b)"> <text>An individual may not be considered an inmate of a public institution if the individual resides in a public:</text> <paragraph num="(i)"> <text>Institution voluntarily and not as the result of a legal criminal process;</text> </paragraph> <paragraph num="(ii)"> <text>Educational or vocational training institution for the purpose of receiving educational or vocational training; or</text> </paragraph> <paragraph num="(iii)"> <text>Institution for the first partial month of residence or for a temporary period pending other arrangements appropriate to the individual's needs.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Hospitalization as a Result of the Commission of a Crime. An individual who is hospitalized as a result of an injury sustained during the commission of a crime and has not yet been incarcerated because of the hospitalization may not be considered an inmate of a public institution.</text> </paragraph> <paragraph num="(d)"> <text>Retaining Inmate Status. Except as provided in §A(2)(f) of this regulation, an individual's inmate status continues until the criminal indictment against the individual is dismissed or the individual is released from the public institution.</text> </paragraph> <paragraph num="(e)"> <text>An individual who is not present at the correctional facility during the day, because the individual is attending a day treatment program or participating in day-time employment, but who resides in a correctional facility at night, shall be considered an inmate of a public institution.</text> </paragraph> <paragraph num="(f)"> <text>Inmate Admitted to Medical Institution. An inmate may be covered by Medical Assistance during the period when the inmate is admitted as an inpatient of a medical institution, such as a hospital, nursing facility, or juvenile psychiatric facility, and is receiving services covered by Medical Assistance.</text> </paragraph> <paragraph num="(g)"> <text>Individual Sent to an Institution for Mental Disease (IMD).</text> <paragraph num="(i)"> <text>Inmate status shall apply to an individual who is accused of a criminal offense and is sent directly to an IMD either for a mental examination or because the individual is determined mentally incompetent to stand trial.</text> </paragraph> <paragraph num="(ii)"> <text>An individual committed by a court to an IMD based on a verdict of not guilty by reason of insanity may not be considered an inmate of a public institution.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Children Younger than 21 Years Old Committed to a Correctional Facility.</text> <paragraph num="(a)"> <text>A child committed by a court to a correctional institution due to a violation of the law shall be considered incarcerated as an inmate of a public institution.</text> </paragraph> <paragraph num="(b)"> <text>A child committed to the custody of the Maryland Department of Juvenile Services shall be considered incarcerated as an inmate of a public institution if the child is placed in a State-owned and State-operated facility, and that status shall continue until the child is released from the facility.</text> </paragraph> <paragraph num="(c)"> <text>A child committed to the custody of the Maryland Department of Juvenile Services may not be considered an inmate of a public institution if the child is living:</text> <paragraph num="(i)"> <text>With the child's parent, caretaker relative, or legal guardian;</text> </paragraph> <paragraph num="(ii)"> <text>In a group home serving no more than 16 residents; or</text> </paragraph> <paragraph num="(iii)"> <text>In a privately operated facility under the jurisdiction of the Maryland Department of Juvenile Services.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Institution for Mental Disease (IMD).</text> <paragraph num="(1)"> <text>An institutionalized individual younger than 65 years old who is admitted for residence in an institution for mental disease is not eligible for Medical Assistance, unless the applicant or recipient is:</text> <paragraph num="(a)"> <text>Younger than 22 years old; and</text> </paragraph> <paragraph num="(b)"> <text>Receiving inpatient psychiatric services for individuals younger than 21 years old.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Inpatient psychiatric services for individuals younger than 21 years old may be provided:</text> <paragraph num="(a)"> <text>To individuals who are younger than 21 years old; or</text> </paragraph> <paragraph num="(b)"> <text>Until the earlier of the date that the individual:</text> <paragraph num="(i)"> <text>No longer requires the services; or</text> </paragraph> <paragraph num="(ii)"> <text>Is 22 years old, if the individual was receiving the services immediately before reaching 21 years old.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except as provided in §B(4) of this regulation, when an individual is on conditional release or convalescent leave from an IMD, the individual may not be considered institutionalized in the IMD.</text> </paragraph> <paragraph num="(4)"> <text>An individual who is receiving inpatient psychiatric services for individuals younger than 21 years old shall be considered an institutionalized individual until the earlier of the date that the individual:</text> <paragraph num="(a)"> <text>Is unconditionally released from the IMD; or</text> </paragraph> <paragraph num="(b)"> <text>Is 22 years old.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="MAGI Exempt Assistance Unit."> <paragraph num="A."> <text>Purpose and Scope. This regulation establishes who shall be a member of an assistance unit, who may be excluded from an assistance unit, who will have separate eligibility determinations, and whose income and resources will be considered in determining financial eligibility for MAGI Exempt applicants and recipients of Medical Assistance.</text> </paragraph> <paragraph num="A-1."> <text>More Than One Assistance Unit Among Individuals Living Together. More than one assistance unit is permissible if:</text> <paragraph num="(1)"> <text>The parent or other caretaker relative chooses to have a child's eligibility determined as blind or disabled under Regulation .04J of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A caretaker relative chooses to have his eligibility determined as aged, blind, or disabled under Regulation .04J of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>There are individuals who would have been members of the assistance unit except for their status as automatically eligible Medical Assistance recipients under Regulation .03B of this chapter.</text> </paragraph> </paragraph> <paragraph num="A-2."> <text>Separate Eligibility Determinations for Certain Individuals.</text> <paragraph num="(1)"> <text>An individual eligibility determination shall be conducted for each individual identified in §A-1(1) of this regulation who requests Medical Assistance.</text> </paragraph> <paragraph num="(2)"> <text>For the aged, blind, or disabled individual identified in §A-1(2) of this regulation:</text> <paragraph num="(a)"> <text>If the person chooses to have eligibility determined as aged, blind, or disabled and either the person's spouse is non-aged, blind, or disabled or the aged, blind, or disabled spouse chooses to have eligibility determined as a caretaker relative, an individual eligibility determination shall be conducted; or</text> </paragraph> <paragraph num="(b)"> <text>If the person applies as aged, blind, or disabled and the person's spouse also applies as aged, blind, or disabled, the couple will be considered one unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Aged, Blind, or Disabled.</text> <paragraph num="(1)"> <text>This section is applicable to the following:</text> <paragraph num="(a)"> <text>An aged, blind, or disabled person 21 years old or older who has no unmarried related children younger than 21 years old living with him;</text> </paragraph> <paragraph num="(b)"> <text>An aged, blind, or disabled person and spouse, with no unmarried related children younger than 21 years old living with the couple;</text> </paragraph> <paragraph num="(c)"> <text>A blind or disabled child younger than 21 years old who chooses to have his eligibility determined as blind or disabled; and</text> </paragraph> <paragraph num="(d)"> <text>An aged, blind, or disabled caretaker relative who chooses to have his eligibility determined as aged, blind, or disabled.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Composition—Aged, Blind, or Disabled.</text> <paragraph num="(a)"> <text>The assistance unit shall include the following persons, except as provided in §B(2)(b)—(c) of this regulation:</text> <paragraph num="(i)"> <text>The aged, blind, or disabled person; and</text> </paragraph> <paragraph num="(ii)"> <text>The aged, blind, or disabled spouse of the aged, blind, or disabled person, when living together.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An aged, blind, or disabled caretaker relative who chooses to apply as caretaker relative will not be included in the unit.</text> </paragraph> <paragraph num="(c)"> <text>A non-aged, blind, or disabled parent or caretaker relative other than parent will not be included in the unit.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Income and Resource Consideration.</text> <paragraph num="(a)"> <text>In determining financial eligibility, the income and resources of the following persons shall be considered:</text> <paragraph num="(i)"> <text>All persons included in the assistance unit;</text> </paragraph> <paragraph num="(ii)"> <text>The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and</text> </paragraph> <paragraph num="(iii)"> <text>The parent of a blind or disabled child younger than 18 years old, when living together, unless the parent is an SSI recipient.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Treatment of Income and Resources of Persons Not Living Together.</text> <paragraph num="(i)"> <text>When spouses cease to live together, their income and resources shall be considered available to each other throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the spouse shall be counted.</text> </paragraph> <paragraph num="(ii)"> <text>When a blind or disabled child younger than 18 years old ceases to live with his parent, the income and resources of the parent shall be considered available throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the parents shall be counted.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Blind and Disabled Children Living With Parents or Other Caretaker Relatives.</text> <paragraph num="(1)"> <text>This section applies to blind or disabled children living with a caretaker relative who chooses to have the child's eligibility determined as an individual younger than 21 years old and an aged, blind, or disabled individual who chooses to have his eligibility determined as a caretaker relative.</text> </paragraph> <paragraph num="(2)"> <text>Persons Living Together. The unit shall be established on the basis of persons living together, including persons who are temporarily absent from the home for purposes of attending school, or pursuing vocational or job training.</text> </paragraph> <paragraph num="(3)"> <text>Composition — Children Living With Parents or Other Caretaker Relatives. The assistance unit shall include, except as provided in §§A-1 and C(4) of this regulation, the parents, caretaker relatives other than parents, their unmarried children younger than 21 years old, and any other unmarried children younger than 21 years old (including second generation children who are parented by an unmarried person younger than 21 years old) who are related by blood, marriage, or adoption to the parent or caretaker relative other than parent. The relationship between children and caretaker relatives other than parents shall be limited to those specified in Regulation .02B(10)(a) of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Exclusion of a Child or Caretaker Relative Other Than Parent.</text> <paragraph num="(a)"> <text>The provisions of §C(3) of this regulation may not apply when:</text> <paragraph num="(i)"> <text>A parent or caretaker relative other than a parent chooses to exclude a child from the assistance unit provided at least one child is in the unit and the exclusion does not cause the applicant or recipient to lose Medical Assistance (Title XIX) status as a caretaker relative as defined in Regulation .02B(10)(a) of this chapter.</text> </paragraph> <paragraph num="(ii)"> <text>A caretaker relative other than a parent chooses to be excluded from the assistance unit. The choice of exclusion includes the caretaker relative's spouse.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An excluded aged, blind, or disabled person retains the option of selecting any federal category in which technical eligibility may be established upon subsequent application.</text> </paragraph> <paragraph num="(c)"> <text>An excluded non-aged, blind, or disabled person may not have a separate eligibility determination.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Subsequent Application for an Excluded Person.</text> <paragraph num="(a)"> <text>A person excluded from the assistance unit may apply for Medical Assistance.</text> </paragraph> <paragraph num="(b)"> <text>If an excluded person applies as aged, blind, or disabled, the following conditions apply:</text> <paragraph num="(i)"> <text>A separate eligibility determination will be made in accordance with §A-1 of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Income and resources of a spouse or parent will be considered in accordance with §B(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If an excluded person does not apply as aged, blind, or disabled, the following conditions apply:</text> <paragraph num="(i)"> <text>The period under consideration will be the same as that of the currently eligible assistance unit;</text> </paragraph> <paragraph num="(ii)"> <text>Eligibility for the new member shall be determined in conjunction with the currently eligible assistance unit established in §C(3) of this regulation;</text> </paragraph> <paragraph num="(iii)"> <text>The income and resources of the new member shall be added to that of the currently eligible assistance unit beginning with the month for which coverage of the new member is requested;</text> </paragraph> <paragraph num="(iv)"> <text>The income of the new member may not be averaged to include any months before the month for which coverage is requested;</text> </paragraph> <paragraph num="(v)"> <text>Certification may not begin earlier than the date the new member becomes eligible; and</text> </paragraph> <paragraph num="(vi)"> <text>A decision of ineligibility for the new member will not affect the eligibility status of the currently eligible assistance unit for the remainder of the certification period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Income and Resource Consideration.</text> <paragraph num="(a)"> <text>In determining financial eligibility, the income and resources of the following persons shall be considered:</text> <paragraph num="(i)"> <text>All persons included in the assistance unit;</text> </paragraph> <paragraph num="(ii)"> <text>The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and</text> </paragraph> <paragraph num="(iii)"> <text>The parent of a child younger than 21 years old, when living together, unless the parent is an SSI recipient.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Treatment of Income and Resources When a Child Leaves the Home. The income and resources of a parent shall be considered throughout the month in which a child leaves the home for the purpose of establishing a new address, when the separation is for reasons other than placement in a foster home, group home, or drug or alcohol abuse treatment center. Beginning with the first full month of separate residence, only actually contributed income and resources from the parent shall be counted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Additions to the Household. A new member of the household will be considered in accordance with all applicable regulations of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="MAGI Household Unit."> <paragraph num="A."> <text>Purpose and Scope.</text> <paragraph num="(1)"> <text>This regulation establishes who shall be a member of the MAGI household and who will be excluded from the MAGI household.</text> </paragraph> <paragraph num="(2)"> <text>The regulation applies to applicants and recipients of coverage groups described under Regulation .03A of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Household Composition.</text> <paragraph num="(1)"> <text>An individual, plus anyone for whom the individual claims a personal exemption, shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made.</text> </paragraph> <paragraph num="(2)"> <text>For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals:</text> <paragraph num="(a)"> <text>Spouse; and</text> </paragraph> <paragraph num="(b)"> <text>Natural, adopted or step children.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a child applicant the household size shall consist of the child and the following individuals:</text> <paragraph num="(a)"> <text>Natural, adopted, or step parents; and</text> </paragraph> <paragraph num="(b)"> <text>Natural, adopted, or step siblings.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return.</text> </paragraph> <paragraph num="(5)"> <text>In the case of determining the household size of a pregnant woman, the pregnant woman shall be counted as herself plus the number of children she is expected to deliver.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Consideration of Income."> <paragraph num="A."> <text>This regulation contains the rules for considering earned and unearned income of:</text> <paragraph num="(1)"> <text>Members of the MAGI household unit and those individuals whose income is considered pursuant to Regulation .06-1 of this chapter in determining financial eligibility of individuals for retroactive and current eligibility for the period under consideration; or</text> </paragraph> <paragraph num="(2)"> <text>Members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>“Disregard” means the amount of money specified by regulation that can be subtracted from countable income.</text> </paragraph> <paragraph num="(2)"> <text>“Excludable income” means income which is exempt from consideration as countable income.</text> </paragraph> <paragraph num="(3)"> <text>“Federal Supplemental Nutrition Assistance Program (SNAP)”, formerly the Food Stamp Program, has the meaning stated in COMAR 07.03.17.01.</text> </paragraph> <paragraph num="(4)"> <text>“Income tax” means federal, state, or local taxes either paid or withheld from income of a self-employed person not to exceed the tax table amount for the number of known dependents.</text> </paragraph> <paragraph num="(5)"> <text>“Modified Adjusted Gross Income (MAGI) based income” means income calculated using the same financial methodologies used to determine modified adjusted gross income as defined in 42 CFR 435.603 , with the following exceptions:</text> <paragraph num="(a)"> <text>An amount received as a lump sum is counted as income only in the month received;</text> </paragraph> <paragraph num="(b)"> <text>Scholarships, awards, or fellowship grants used for education purposes and not for living expenses are excluded from income; and</text> </paragraph> <paragraph num="(c)"> <text>American Indian or Alaska Native exceptions in accordance with 42 CFR 435.603.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant shall report all income. When there is evidence of regular expenditures which are inconsistent with reported income, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> <paragraph num="D."> <text>The Department or its designee shall consider all income in accordance with this regulation.</text> </paragraph> <paragraph num="E."> <text>Retroactive Eligibility. The income to be considered is that which was actually available during the retroactive period under consideration.</text> </paragraph> <paragraph num="F."> <text>Current Eligibility. In considering income for current eligibility, the following rules apply:</text> <paragraph num="(1)"> <text>When an individual has regular income in the MAGI coverage group, the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application;</text> </paragraph> <paragraph num="(2)"> <text>When an individual has a regular income in the MAGI Exempt coverage group, the amount to be considered is that which is available, or can reasonably be expected to be available, for a projected period of 6 months including the month of application;</text> </paragraph> <paragraph num="(3)"> <text>For participants currently enrolled in both the Program and SNAP:</text> <paragraph num="(a)"> <text>The Program may renew the individual’s Medicaid eligibility using household income as determined by SNAP without conducting a separate income determination; and</text> </paragraph> <paragraph num="(b)"> <text>An individual is determined eligible when the participant is:</text> <paragraph num="(i)"> <text>Younger than 19 years old and has a SNAP verified income at or below 200 percent of the federal poverty level for individuals in a MAGI coverage group;</text> </paragraph> <paragraph num="(ii)"> <text>Younger than 19 years old and has a SNAP verified income at or below 300 percent of the federal benefit rate for individuals in a MAGI exempt coverage group; or</text> </paragraph> <paragraph num="(iii)"> <text>Between 19 to 64 years old and has a SNAP verified income at or below 138 percent of the federal poverty level for individuals in a MAGI coverage group;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>When a member of a MAGI exempt assistance unit works for less than 12 months but receives an annual salary, is self-employed, or has irregular or seasonal earning, the amount to be considered is one-half the expected annual income based on the prior year's gross income; and</text> </paragraph> <paragraph num="(5)"> <text>For a deceased individual, the income to be considered is that which was available up to and including the month of death. When there are other individuals in the assistance unit or MAGI household unit, the deceased individual's income will be averaged over the unit's established period under consideration.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Treatment of Income.</text> <paragraph num="(1)"> <text>All earned and unearned income which is not designated as excludable income pursuant to §J of this regulation shall be counted to establish countable gross income.</text> </paragraph> <paragraph num="(2)"> <text>Countable gross income for MAGI Exempt coverage groups shall be reduced by subtracting appropriate income disregards as specified in §K of this regulation to determine countable net income.</text> </paragraph> <paragraph num="(3)"> <text>Countable gross income for MAGI coverage groups shall be the household income calculated according to MAGI.</text> </paragraph> <paragraph num="(4)"> <text>MAGI income limits shall be:</text> <paragraph num="(a)"> <text>Converted from traditional income limits to account for elimination of income disregards; and</text> </paragraph> <paragraph num="(b)"> <text>Increased by 5 percentage points of the federal poverty level for the following circumstances:</text> <paragraph num="(i)"> <text>When an individual’s income exceeds the Medicaid income standard; and</text> </paragraph> <paragraph num="(ii)"> <text>The income standard is the highest income standard under which the individual can be determined eligible.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Earned income includes the following:</text> <paragraph num="(1)"> <text>Wages.</text> </paragraph> <paragraph num="(2)"> <text>Commissions and fees.</text> </paragraph> <paragraph num="(3)"> <text>Salaries and tips.</text> </paragraph> <paragraph num="(4)"> <text>The value of in-kind goods and services received as a result of employment.</text> </paragraph> <paragraph num="(5)"> <text>Profit from self-employment income of MAGI exempt coverage groups, as described in §K(3)(a)of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>Remuneration received for work or for activities performed as a participant in a program conducted by a sheltered workshop or activities center.</text> </paragraph> <paragraph num="(7)"> <text>The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973.</text> </paragraph> <paragraph num="(8)"> <text>Sick pay which counts as earnings for deduction purposes under Title II of the Social Security Act.</text> </paragraph> <paragraph num="(9)"> <text>Work study earnings.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Unearned income includes the following:</text> <paragraph num="(1)"> <text>Benefits and income from:</text> <paragraph num="(a)"> <text>Social Security;</text> </paragraph> <paragraph num="(b)"> <text>Veterans Administration;</text> </paragraph> <paragraph num="(c)"> <text>Workmen's Compensation Board;</text> </paragraph> <paragraph num="(d)"> <text>Black Lung Program;</text> </paragraph> <paragraph num="(e)"> <text>Railroad Retirement Board;</text> </paragraph> <paragraph num="(f)"> <text>Government, private, or company pensions and annuities;</text> </paragraph> <paragraph num="(g)"> <text>Unemployment benefit plans;</text> </paragraph> <paragraph num="(h)"> <text>Unemployment supplemental benefit plans;</text> </paragraph> <paragraph num="(i)"> <text>Payments from oil or mineral rights (leases);</text> </paragraph> <paragraph num="(j)"> <text>Government payments on land;</text> </paragraph> <paragraph num="(k)"> <text>Insurance benefits paid directly to a person;</text> </paragraph> <paragraph num="(l)"> <text>Trust funds;</text> </paragraph> <paragraph num="(m)"> <text>Individual Retirement Accounts (IRA's);</text> </paragraph> <paragraph num="(n)"> <text>Keogh Plans;</text> </paragraph> <paragraph num="(o)"> <text>Military allotments.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Alimony, court-ordered and voluntary support payments received from an absent spouse, or an absent natural or adoptive parent.</text> </paragraph> <paragraph num="(3)"> <text>Financial contributions received from persons or public or private agencies.</text> </paragraph> <paragraph num="(4)"> <text>In-kind Support—Aged, Blind, or Disabled.</text> <paragraph num="(a)"> <text>One-third the appropriate medically needy income level for the number of persons in an aged, blind, or disabled assistance unit, when:</text> <paragraph num="(i)"> <text>A person receives in-kind support in the form of food and shelter while living in the household of another, and</text> </paragraph> <paragraph num="(ii)"> <text>The person pays less than his pro rata share of the total household expenses for food and shelter, unless he documents otherwise.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The value of actual payments for food, shelter, or both made by other persons on behalf of the assistance unit.</text> </paragraph> <paragraph num="(c)"> <text>The fair market value of free shelter received while living in an independent dwelling unit. When the person fails to present evidence of the fair market value of the dwelling unit, the presumed value shall be 1/3 the appropriate medically needy income level for the number of persons in the assistance unit.</text> </paragraph> <paragraph num="(d)"> <text>This provision may not apply to persons residing in public or private institutions, foster homes, group homes, or commercial establishments.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Interest, dividends, royalties, or other income accrued to stocks, bonds, insurance, and savings certificates if the income is available to the person on a regular basis.</text> </paragraph> <paragraph num="(6)"> <text>Interest or dividends accrued to savings accounts.</text> </paragraph> <paragraph num="(7)"> <text>Mortgage payments.</text> </paragraph> <paragraph num="(8)"> <text>Lump sum benefits or other amounts of income received on a one-time-only basis including gifts, inheritances, retroactive benefit payments, lottery winnings, damage claims unless specifically excluded by other regulations, or any other lump sums or portions of them that are not excluded under §J or K of this regulation.</text> </paragraph> <paragraph num="(9)"> <text>Profit from Rental Income as described in §§L(3)(b) and M(2)(c)(ii) of this regulation.</text> </paragraph> <paragraph num="(10)"> <text>Cash assistance received from nongovernmental social agencies unless excluded under the provisions of §J or §K of this regulation.</text> </paragraph> <paragraph num="(11)"> <text>Grants, loans, scholarships, and fellowships for educational purposes, except as specified in §J(3) and (9) of this regulation.</text> </paragraph> <paragraph num="(12)"> <text>Cash assistance, including Public Assistance grants and SSI benefits, except as specified in Regulation .06B(3)(a)(ii) and .06C(4)(a)(ii) of this chapter.</text> </paragraph> <paragraph num="(13)"> <text>Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Excludable Income—Aged, Blind, or Disabled. Income from the following sources shall be excluded in determining countable gross income:</text> <paragraph num="(1)"> <text>The value of the coupon allotment under the Food Stamp Program.</text> </paragraph> <paragraph num="(2)"> <text>Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq., excluding compensation received for the fair market value of the acquired real property.</text> </paragraph> <paragraph num="(3)"> <text>Grants or loans to an undergraduate student for educational purposes made or insured under any program administered by the Secretary, U.S. Department of Education.</text> </paragraph> <paragraph num="(4)"> <text>Work-study earnings, work-study stipends, and reimbursement for out-of-pocket expenses of a student.</text> </paragraph> <paragraph num="(5)"> <text>Benefits received under Title III C Nutrition Program for the Elderly of the Older Americans Act of 1965, as amended.</text> </paragraph> <paragraph num="(6)"> <text>Stipends, compensation, or expenses received by volunteers from a program existing or to be set up under the “Domestic Volunteer Service Act of 1973” sponsored by ACTION, such as but not limited to:</text> <paragraph num="(a)"> <text>(PLS) Demonstration Project Program for Local Services;</text> </paragraph> <paragraph num="(b)"> <text>VISTA (Volunteers in Service to America);</text> </paragraph> <paragraph num="(c)"> <text>UYA (University Year for Action);</text> </paragraph> <paragraph num="(d)"> <text>RSVP (Retired Senior Volunteer Program);</text> </paragraph> <paragraph num="(e)"> <text>Foster Grandparents;</text> </paragraph> <paragraph num="(f)"> <text>Older American Community Service Program;</text> </paragraph> <paragraph num="(g)"> <text>SCORE (Service Corps of Retired Executives); and</text> </paragraph> <paragraph num="(h)"> <text>ACE (Action Corps of Executives).</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The value of supplemental food assistance received under the Child Nutrition Act of 1966 as amended, and the special food service program for children under the National School Lunch Act, as amended.</text> </paragraph> <paragraph num="(8)"> <text>The value of livestock and home produce used for own consumption.</text> </paragraph> <paragraph num="(9)"> <text>Educational Expenses.</text> <paragraph num="(a)"> <text>The portion of educational grants, loans, scholarships, and fellowships that is designated and used solely for undergraduate and graduate educational pursuits such as tuitions, books, mandatory fees, transportation to and from educational institutions, and the cost of child care while in attendance.</text> </paragraph> <paragraph num="(b)"> <text>These expenses may be allowed to the extent that there are insufficient funds from those grants and loans specified under §J(3) of this regulation to cover these expenses.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The earned income of a blind or disabled child who is younger than 22 years old and regularly attending school, including a college, university, or vocational training school, not to exceed $1,620 a calendar year.</text> </paragraph> <paragraph num="(11)"> <text>Payments received from providing foster care or subsidized adoption services to a child placed in the home by a public or private nonprofit child placement or child care agency.</text> </paragraph> <paragraph num="(12)"> <text>Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act.</text> </paragraph> <paragraph num="(13)"> <text>The value of rent subsidies or other assistance received by a person for his dwelling unit under:</text> <paragraph num="(a)"> <text>The U.S. Housing Act of 1937, 42 U.S.C. §§1400 et seq.;</text> </paragraph> <paragraph num="(b)"> <text>The National Housing Act, 12 U.S.C. §§1701 et seq.;</text> </paragraph> <paragraph num="(c)"> <text>Section 101 of the Housing and Urban Development Act of 1965, 42 U.S.C. §§1400 et seq.;</text> </paragraph> <paragraph num="(d)"> <text>Title V of the Housing Act of 1949, 12 U.S.C. §§1601 et seq.; 42 U.S.C. §§1400 et seq.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Infrequent or Irregular Earned Income. Infrequent or irregular earned income shall be excluded if:</text> <paragraph num="(a)"> <text>The total gross amount does not exceed $30 per quarter; and</text> </paragraph> <paragraph num="(b)"> <text>It is received less frequently than twice per quarter or cannot be reasonably anticipated.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Infrequent or Irregular Unearned Income. Infrequent or irregular unearned income shall be excluded if:</text> <paragraph num="(a)"> <text>The total amount does not exceed $200 per 6 months; and</text> </paragraph> <paragraph num="(b)"> <text>It is received less frequently than twice per quarter or cannot be reasonably anticipated.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>The value of earned and unearned in-kind income.</text> </paragraph> <paragraph num="(17)"> <text>Third-party payments for food, clothing, shelter, or other goods and services made on behalf of an assistance unit or other persons whose income and resources are considered in determining eligibility, if the payment is not reimbursement for services rendered by a member of the assistance unit or other persons whose income and resources are considered.</text> </paragraph> <paragraph num="(18)"> <text>The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973.</text> </paragraph> <paragraph num="(19)"> <text>Reparation payments made by the Federal Republic of Germany.</text> </paragraph> <paragraph num="(20)"> <text>For recipients of a VA pension who have neither spouse nor child, the VA payment not to exceed $90 per month beginning the month after the month of admission to a long-term care facility.</text> </paragraph> <paragraph num="(21)"> <text>Cash, including interest earned on the cash, or in-kind replacement received from any source for purposes of repairing or replacing an excluded resource that is lost, damaged, or stolen is not income but continues to be considered as an excluded resource in accordance with the provisions of Regulation .08G(7) of this chapter.</text> </paragraph> <paragraph num="(22)"> <text>Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States is not income but an excluded resource.</text> </paragraph> <paragraph num="(23)"> <text>Support and Maintenance (In-Kind Income) Provided as Replacement for an Excluded Home Because of a Casualty Loss or a Presidentially Declared Major Disaster.</text> <paragraph num="(a)"> <text>When an excluded home is damaged or destroyed and temporary housing is furnished to a person who owned an excluded home, the in-kind support and maintenance is not counted as income. This temporary housing is intended to replace the home pending repair or replacement of the excluded home.</text> </paragraph> <paragraph num="(b)"> <text>When an excluded home is damaged or destroyed as a result of a presidentially declared major disaster, the value of support and maintenance (in cash or in-kind) received by a person, or couple, is excluded, if:</text> <paragraph num="(i)"> <text>The person, or couple, was residing in the household as a home when a catastrophe occurred in the area in which the home was located;</text> </paragraph> <paragraph num="(ii)"> <text>The catastrophe was declared by the President to be a major disaster for purposes of the Disaster Relief Act of 1974;</text> </paragraph> <paragraph num="(iii)"> <text>The person, or couple, stopped living in the home because of the catastrophe and, within 30 days after the catastrophe, began to receive the support and maintenance; and</text> </paragraph> <paragraph num="(iv)"> <text>The person, or couple, received the support and maintenance while living in a residential facility, including a private home, maintained by another person.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>Any amount refunded from any public agency, if paid on the purchase of food or the satisfaction of real property levies.</text> </paragraph> <paragraph num="(25)"> <text>One-third of support payments made to or for a blind or disabled child by an absent parent.</text> </paragraph> <paragraph num="(26)"> <text>Interest income accrued to a:</text> <paragraph num="(a)"> <text>Bank account during the period under consideration, such as a checking, savings, or money market account;</text> </paragraph> <paragraph num="(b)"> <text>Dedicated bank or other financial institution account that is considered an excludable resource because it is unavailable, such as an escrow account for a security deposit; or</text> </paragraph> <paragraph num="(c)"> <text>Keogh account, individual retirement account (IRA), or other private retirement account that is countable as a resource.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>Interest payments received for a mortgage, promissory note, or other loan.</text> </paragraph> <paragraph num="(28)"> <text>Refund of taxes on income, property, food, or other items already paid.</text> </paragraph> <paragraph num="(29)"> <text>Proceeds of a loan received by an individual as the borrower.</text> </paragraph> <paragraph num="(30)"> <text>Payments received from a trust, if the trust is countable as a resource.</text> </paragraph> <paragraph num="(31)"> <text>Income from the sale of an assistance unit member's blood or plasma.</text> </paragraph> <paragraph num="(32)"> <text>Cash donations based on need received from one or more charitable organizations.</text> </paragraph> <paragraph num="(33)"> <text>All income excluded by federal statute for medical assistance programs.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Disregards — Aged, Blind, or Disabled. In order to determine countable net income, the following disregards shall be deducted from the countable gross income of an aged, blind, or disabled assistance unit:</text> <paragraph num="(1)"> <text>A general disregard of $20 per month for a person or a couple.</text> </paragraph> <paragraph num="(2)"> <text>An earned income disregard of $65 per month plus one-half of the remainder of the earned income of a person or a couple.</text> </paragraph> <paragraph num="(3)"> <text>A disregard of one-half of the gross income amount for the following types of income:</text> <paragraph num="(a)"> <text>Profit from self-employment income, unless an applicant or recipient can document a cost to produce in excess of the disregard of one-half of gross income; and</text> </paragraph> <paragraph num="(b)"> <text>Profit from rental property income and other income-producing property.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The amount of earned income used to meet any expenses reasonably attributable to earning of income of a blind person younger than 65 years old in accordance with 20 CFR §416.1112(c)(5).</text> </paragraph> <paragraph num="(5)"> <text>Any wages, allowances, or reimbursement for transportation and attendant care costs, unless excepted on a case-by-case basis, when received by a blind or disabled handicapped person employed in a project under Title VI of the Rehabilitation Act of 1973 as added by Title II of Pub. L. No. 95-602 (92 Stat. 2992, 29 U.S.C. §795(b)(c)).</text> </paragraph> </paragraph> <paragraph num="L."> <text>Schedule MA-1.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Consideration of Resources for MAGI Exempt Coverage Groups."> <paragraph num="A."> <text>This regulation contains the rules for considering resources of members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration.</text> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>“Account” means cash savings or any other form of liquid resource in a bank, credit union, savings and loan association, or any other financial institution in which the resource is subject to withdrawal by the owner or owners of the account.</text> </paragraph> <paragraph num="(2)"> <text>Automobile.</text> <paragraph num="(a)"> <text>“Automobile” means a passenger car or any other vehicle used to provide necessary transportation.</text> </paragraph> <paragraph num="(b)"> <text>“Automobile” does not mean an airplane, farm machinery, or a vehicle used solely for recreational purposes.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Burial funds” means a revocable burial contract, burial trust, or other burial arrangement or any other separately identifiable fund which is clearly designated as set aside for a person's burial expenses.</text> </paragraph> <paragraph num="(4)"> <text>“Burial spaces” means conventional gravesites, crypts, mausoleums, urns, and other repositories which are customarily and traditionally used for the remains of deceased persons.</text> </paragraph> <paragraph num="(5)"> <text>“Equity value” means the fair market value of property less any legal debt on the property.</text> </paragraph> <paragraph num="(6)"> <text>“Fair market value” means the amount for which property can be sold on the open market in a particular geographical area.</text> </paragraph> <paragraph num="(7)"> <text>“Funds in an irrevocable trust or other irrevocable arrangement that are available to meet burial expenses” means funds which are held in an irrevocable burial contract, an irrevocable burial trust, or an amount in an irrevocable trust which is specifically identified as available for burial expenses.</text> </paragraph> <paragraph num="(8)"> <text>“Home” means any shelter in which a member of the assistance unit or any person whose income and resources are considered in determining the financial eligibility of the assistance unit, has an ownership interest and uses as his principal place of residence. The home includes the parcel of land on which the shelter is situated and any related outbuildings necessary to its operation. Only one residence may be considered home property.</text> </paragraph> <paragraph num="(9)"> <text>“Immediate family” means a person's spouse or a person's minor and adult children, including adopted children and stepchildren, or a person's brothers, sisters, parents, adoptive parents, and the spouses of these persons. Neither dependency nor living in the same household are factors in determining whether a person is an immediate family member.</text> </paragraph> <paragraph num="(10)"> <text>“Institutionalized person” means a person who is:</text> <paragraph num="(a)"> <text>An inpatient in a nursing facility;</text> </paragraph> <paragraph num="(b)"> <text>An inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility; or</text> </paragraph> <paragraph num="(c)"> <text>Receiving services under a home and community-based services waiver under COMAR 10.09.27 or 10.09.31.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Joint account” means an account in which two or more persons are named as owners of the account and the funds in the account are subject to withdrawal by any of the persons named as owners.</text> </paragraph> <paragraph num="(12)"> <text>“Medicaid qualifying trust” means a trust or similar legal device established on or before August 10, 1993, other than by will, by an individual or an individual's spouse, under which the individual or the individual's spouse may be the beneficiary of all or part of the payments from the trust, and the distribution of payment is determined by one or more trustees who are permitted to exercise any discretion with respect to the distribution to the individual.</text> </paragraph> <paragraph num="(13)"> <text>“Nonapplicant” means a person who is neither an applicant nor the spouse of an applicant.</text> </paragraph> <paragraph num="(14)"> <text>Property.</text> <paragraph num="(a)"> <text>“Property” means any thing or things in which a person has a legal or equitable interest.</text> </paragraph> <paragraph num="(b)"> <text>“Personal property” means all property that is not real property.</text> </paragraph> <paragraph num="(c)"> <text>“Real property” means property which is fixed or immovable such as land or a building.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Uncompensated value” means the difference between the fair market value of a person's interest in a resource at the time it was disposed of and the amount of compensation received for the resource.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant shall report all resources to the Department or its designee with the exception of non-disabled children and their caretaker relatives who are not being considered as medically needy.</text> </paragraph> <paragraph num="D."> <text>Countable income that is retained at redetermination or reapplication shall be considered a resource unless specifically excluded by other regulations.</text> </paragraph> <paragraph num="E."> <text>The Department or its designee shall require an accounting and reasonable documentation, consisting of convincing testimony or other evidence, of the disposal of previously held resources within 30 months before the month of application to assure that the resources are no longer available and the disposal meets the requirements of this regulation.</text> </paragraph> <paragraph num="F."> <text>Excludable Resources for Aged, Blind, or Disabled Noninstitutionalized Individuals and Aged, Blind, or Disabled Institutionalized Individuals Who Intend to Return Home. The following resources are excluded in determining financial eligibility for aged, blind, or disabled noninstitutionalized individuals and for an aged, blind, or disabled institutionalized individual who intends to resume living in the individual's home:</text> <paragraph num="(1)"> <text>The home, as defined under §B(7) of this regulation, unless the person is institutionalized and has a life estate interest with full powers in the home.</text> </paragraph> <paragraph num="(2)"> <text>Income-Producing Property.</text> <paragraph num="(a)"> <text>Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. The property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity.</text> </paragraph> <paragraph num="(b)"> <text>Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity.</text> </paragraph> <paragraph num="(c)"> <text>$6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §F(2)(a) and (b) of this regulation. The exclusion does not apply to each individual property.</text> </paragraph> <paragraph num="(d)"> <text>Limitations on Equity Value Exclusion.</text> <paragraph num="(i)"> <text>The full equity value of each property not producing a net annual return of 6 percent will be a countable resource.</text> </paragraph> <paragraph num="(ii)"> <text>The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Household Goods and Personal Effects.</text> <paragraph num="(a)"> <text>Household Goods.</text> <paragraph num="(i)"> <text>Household goods include those items of personal property customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation.</text> </paragraph> <paragraph num="(ii)"> <text>Household goods necessary for the maintenance, use, and occupancy of the home shall be excluded regardless of value. The equity value of nonessential items shall be added to other countable resources and measured against the applicable resource standard.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Personal Effects.</text> <paragraph num="(i)"> <text>Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him.</text> </paragraph> <paragraph num="(ii)"> <text>Personal effects shall be excluded except as specified in §F(3)(b)(iii) of this regulation.</text> </paragraph> <paragraph num="(iii)"> <text>The equity value of nonessential personal effects of considerable value such as furs, and jewelry which is not excluded in §F(3)(c) of this regulation, shall be added to other countable resources and measured against the applicable resource standard.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A wedding ring and an engagement ring shall be excluded from consideration as resources.</text> </paragraph> <paragraph num="(d)"> <text>Prosthetic devices, dialysis machines, hospital beds, wheelchairs, and similar equipment required because of a person's physical condition shall be excluded from consideration as resources.</text> </paragraph> <paragraph num="(e)"> <text>For an institutionalized person, household goods and personal effects remaining in the possession of the person at the long-term care facility shall be excluded from consideration as resources.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Livestock and farm produce that is used only for home consumption.</text> </paragraph> <paragraph num="(5)"> <text>Automobiles.</text> </paragraph> <paragraph num="(6)"> <text>Life Insurance with a Maximum Face Value of $1,500 for Each Person.</text> <paragraph num="(a)"> <text>Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies.</text> </paragraph> <paragraph num="(b)"> <text>Whenever the total face value of all policies on any person exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes available accrued dividends and interest.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Cash and In-Kind Replacement Received for Casualty Losses of Excluded Resources.</text> <paragraph num="(a)"> <text>Cash, including interest earned on the cash, or in-kind replacement received from any source for the purpose of replacing an excluded resource that is lost, damaged, or stolen, shall be an excluded resource for a period of 9 months, beginning with the date the cash or in-kind replacement was received.</text> </paragraph> <paragraph num="(b)"> <text>The initial 9-month exclusion period specified in §F(7)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the individual prevent him from repairing, replacing, or contracting for the repair or replacement of the resource.</text> </paragraph> <paragraph num="(c)"> <text>Any of the cash and interest or in-kind replacement that is not used to repair or replace the excluded resource shall be counted as a resource beginning with the period under consideration after expiration of the initial 9-month period, or the extended period, if any.</text> </paragraph> <paragraph num="(d)"> <text>If an extension of the time period is made pursuant to §F(7)(b) of this regulation and the individual changes his intent to repair or replace the excluded resource, cash and interest, or in-kind replacement previously excluded, shall be counted as resources effective with the month the individual reports his change of intent.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Assistance Received Because of a Major Disaster.</text> <paragraph num="(a)"> <text>Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States shall be excluded in determining countable resources for a period of 9 months from the date of receipt.</text> </paragraph> <paragraph num="(b)"> <text>The initial 9-month period for not counting the assistance specified in §G(8)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the person prevented him from repairing, replacing, or contracting for repair or replacement of damaged or destroyed property.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Burial spaces for a person and the person's immediate family.</text> </paragraph> <paragraph num="(10)"> <text>Proceeds from Sale of a Home. Proceeds from the sale of a home shall be excluded from consideration as a resource for a period not to exceed 3 months from the date the proceeds are received if the:</text> <paragraph num="(a)"> <text>Person indicates he intends to replace the home during that period;</text> </paragraph> <paragraph num="(b)"> <text>Home is in fact replaced during that period; and</text> </paragraph> <paragraph num="(c)"> <text>Replaced home itself was an excluded resource under the provision of §F(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq. Compensation received for the fair market value of the acquired real property is not subject to this regulation.</text> </paragraph> <paragraph num="(12)"> <text>Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act.</text> </paragraph> <paragraph num="(13)"> <text>Burial Funds.</text> <paragraph num="(a)"> <text>In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse.</text> </paragraph> <paragraph num="(b)"> <text>Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund.</text> </paragraph> <paragraph num="(c)"> <text>Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose.</text> </paragraph> <paragraph num="(d)"> <text>If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose.</text> </paragraph> <paragraph num="(e)"> <text>§F(13)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred.</text> </paragraph> <paragraph num="(f)"> <text>An individual's $1,500 exclusion as described under §F(13)(a) of this regulation shall be reduced by:</text> <paragraph num="(i)"> <text>The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and</text> </paragraph> <paragraph num="(ii)"> <text>Amounts in an irrevocable burial fund as described under §F(14) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Excludable Resources for Aged, Blind, or Disabled Institutionalized Individuals Who Do Not Intend to Return Home. The following resources are excluded in determining financial eligibility for an aged, blind, or disabled institutionalized individual who does not intend to resume living in the individual's home:</text> <paragraph num="(1)"> <text>The home as defined in §B(4) of this regulation, if it is occupied by the institutionalized person's spouse or any one of the following relatives who are medically or financially dependent:</text> <paragraph num="(a)"> <text>Son;</text> </paragraph> <paragraph num="(b)"> <text>Daughter;</text> </paragraph> <paragraph num="(c)"> <text>Grandson;</text> </paragraph> <paragraph num="(d)"> <text>Granddaughter;</text> </paragraph> <paragraph num="(e)"> <text>Stepson;</text> </paragraph> <paragraph num="(f)"> <text>Stepdaughter;</text> </paragraph> <paragraph num="(g)"> <text>In-laws;</text> </paragraph> <paragraph num="(h)"> <text>Mother;</text> </paragraph> <paragraph num="(i)"> <text>Father;</text> </paragraph> <paragraph num="(j)"> <text>Stepmother;</text> </paragraph> <paragraph num="(k)"> <text>Stepfather;</text> </paragraph> <paragraph num="(l)"> <text>Half sister;</text> </paragraph> <paragraph num="(m)"> <text>Half brother;</text> </paragraph> <paragraph num="(n)"> <text>Niece;</text> </paragraph> <paragraph num="(o)"> <text>Nephew;</text> </paragraph> <paragraph num="(p)"> <text>Grandmother;</text> </paragraph> <paragraph num="(q)"> <text>Grandfather;</text> </paragraph> <paragraph num="(r)"> <text>Aunt;</text> </paragraph> <paragraph num="(s)"> <text>Uncle;</text> </paragraph> <paragraph num="(t)"> <text>Sister;</text> </paragraph> <paragraph num="(u)"> <text>Brother;</text> </paragraph> <paragraph num="(v)"> <text>Stepbrother;</text> </paragraph> <paragraph num="(w)"> <text>Stepsister.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Household Goods and Personal Effects Remaining in the Possession of the Person at the Long-Term Care Facility.</text> <paragraph num="(a)"> <text>Household goods include those items of personal property which are customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation.</text> </paragraph> <paragraph num="(b)"> <text>Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him.</text> </paragraph> <paragraph num="(c)"> <text>Household goods and personal effects include, but are not limited to, items of personal clothing, toilet articles, prosthetic devices, an engagement ring, and a wedding ring.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Life Insurance with a Maximum Face Value of $1,500 for Each Person.</text> <paragraph num="(a)"> <text>Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies.</text> </paragraph> <paragraph num="(b)"> <text>Whenever the total face value of all policies exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes all available accrued dividends and interest.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Burial spaces for a person and the person's immediate family.</text> </paragraph> <paragraph num="(5)"> <text>Income-Producing Property.</text> <paragraph num="(a)"> <text>Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity.</text> </paragraph> <paragraph num="(b)"> <text>Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity.</text> </paragraph> <paragraph num="(c)"> <text>$6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §G(5)(a) and (b) of this regulation. The exclusion does not apply to each individual property.</text> </paragraph> <paragraph num="(d)"> <text>Limitations on Equity Value Exclusion.</text> <paragraph num="(i)"> <text>The full equity value of each property not producing a net annual return of 6 percent will be a countable resource.</text> </paragraph> <paragraph num="(ii)"> <text>The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Burial Funds.</text> <paragraph num="(a)"> <text>In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse.</text> </paragraph> <paragraph num="(b)"> <text>Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund.</text> </paragraph> <paragraph num="(c)"> <text>Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose.</text> </paragraph> <paragraph num="(d)"> <text>If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose.</text> </paragraph> <paragraph num="(e)"> <text>Section G(6)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred.</text> </paragraph> <paragraph num="(f)"> <text>An individual's $1,500 exclusion as described under §G(6)(a) of this regulation shall be reduced by:</text> <paragraph num="(i)"> <text>The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and</text> </paragraph> <paragraph num="(ii)"> <text>Amounts in an irrevocable burial fund as described under §G(7) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Exclusion of the home under §§F(1) and G(1) of this regulation and exclusion of income-producing property under §§F(1) and G(5) of this regulation do not prevent a lien being attached to or executed on the home or property except as provided in Regulation .15A-2(3) of this chapter.</text> </paragraph> <paragraph num="I."> <text>Treatment of Joint Accounts.</text> <paragraph num="(1)"> <text>If a joint account exists between an applicant and a nonapplicant, all of the funds in the account are considered available to the applicant.</text> </paragraph> <paragraph num="(2)"> <text>If a joint account exists between the spouse of an applicant and a nonapplicant, all of the funds in the account are considered available to the spouse of the applicant.</text> </paragraph> <paragraph num="(3)"> <text>If a joint account exists between an applicant, the spouse of an applicant, and a nonapplicant, all of the funds in the account are considered available to the applicant and the spouse of the applicant.</text> </paragraph> <paragraph num="(4)"> <text>Rebuttal of Presumption of Full Ownership Interest.</text> <paragraph num="(a)"> <text>If the nonapplicant owner can demonstrate, to the Department's satisfaction, that the nonapplicant made regular and proportionate contributions of the nonapplicant's own funds to the account, a pro rata share of the funds is considered available to the nonapplicant.</text> </paragraph> <paragraph num="(b)"> <text>If either the applicant, the spouse of the applicant, or the nonapplicant owner of a joint account believes that the ownership interest attributed to him or her by the Department under §I(1)—(3) or (4)(a) of this regulation is incorrect and can demonstrate, under §I(5)(b)of this regulation, to the satisfaction of the Department, an ownership interest other than that attributed to him or her by the Department, the Department shall consider the amount established through rebuttal as the correct amount for the purpose of determining eligibility for Medical Assistance.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Declaration of Ownership Interests.</text> <paragraph num="(a)"> <text>The applicant and the nonapplicant of a joint account shall declare their ownership interests on a form designated by the Department.</text> </paragraph> <paragraph num="(b)"> <text>The applicant shall provide adequate documentation to substantiate the declared ownership interests.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the nonapplicant owner withdraws funds from the account during or after the 30-month period immediately before the month of application, the withdrawal is considered a disposal by the applicant or the spouse of the applicant to the extent that the remaining funds are less than the amounts considered available to the applicant under §I(1)—(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Medicaid Qualifying Trust.</text> <paragraph num="(1)"> <text>In the case of a Medicaid qualifying trust as defined under §B(12) of this regulation, the amount from the trust considered available to the person or the person's spouse establishing the trust is the maximum amount of payments that may be permitted under the terms of the trust to the beneficiary, assuming the full exercise of discretion by the trustee or trustees for the distribution of the maximum amount to the beneficiary.</text> </paragraph> <paragraph num="(2)"> <text>Section J of this regulation shall apply whether or not the:</text> <paragraph num="(a)"> <text>Medicaid qualifying trust is irrevocable or has been established for purposes other than to enable a person to qualify for Medical Assistance; or</text> </paragraph> <paragraph num="(b)"> <text>Discretion described under §J of this regulation is actually exercised.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the beneficiary of a trust is an intellectually disabled person who resides in an intermediate care facility for the intellectually disabled, the trust may not be considered a Medicaid qualifying trust if it was established before April 17, 1986 and is solely for the benefit of the intellectually disabled person.</text> </paragraph> <paragraph num="(4)"> <text>The Department may waive the application of §J of this regulation if the Department determines that to do so would work an undue hardship.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Disposal of Resources for Less than Fair Market Value.</text> <paragraph num="(1)"> <text>In determining eligibility for Medical Assistance for any period under consideration beginning before October 1, 1993, an institutionalized individual shall be determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for waiver services under COMAR 10.09.27 and 10.09.31 if the individual or the individual's spouse:</text> <paragraph num="(a)"> <text>Disposes of a resource for less than fair market value at any time during or after the 30-month period immediately before or after the date the person becomes an institutionalized person if the person is entitled to Medical Assistance on that date; or</text> </paragraph> <paragraph num="(b)"> <text>If not entitled to Medical Assistance on that date, then on the date the person applies for Medical Assistance while an institutionalized person.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a person disposes of a resource for less than fair market value while in a period of ineligibility for an earlier disposal, the later disposal is considered a part of the earlier disposal for purposes of computing the total period of ineligibility.</text> </paragraph> <paragraph num="(3)"> <text>The period of ineligibility shall begin with the month in which the resource was transferred and the number of months in the period shall be equal to the lesser of:</text> <paragraph num="(a)"> <text>30 months; or</text> </paragraph> <paragraph num="(b)"> <text>The total uncompensated value of the transferred resource, divided by the average cost, to a private patient at the time of application, of nursing facility services in the state in which the person is institutionalized.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An institutionalized person may not be determined ineligible for Medical Assistance under §K(1) of this regulation if the resource transferred was a home and title to the home was transferred to:</text> <paragraph num="(a)"> <text>The spouse of the person;</text> </paragraph> <paragraph num="(b)"> <text>The person's child as defined under Regulation .02B(12) of this chapter or who is blind or disabled as determined under Regulation .05D and E of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>A sibling of the person who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the person became an institutionalized person; or</text> </paragraph> <paragraph num="(d)"> <text>A son or daughter of the person other than the person's child described under §K(4)(b) of this regulation, who:</text> <paragraph num="(i)"> <text>Is lawfully residing in the home,</text> </paragraph> <paragraph num="(ii)"> <text>Was residing in the home for a period of at least 2 years immediately before the date the person became an institutionalized person, and</text> </paragraph> <paragraph num="(iii)"> <text>Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the person to reside at home rather than in an institution.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A person may not be determined ineligible for Medical Assistance by reason of the transfer of any resource, excluded or nonexcluded, if the resource was transferred under any one of the conditions below:</text> <paragraph num="(a)"> <text>The resource was transferred to the community spouse, or to another for the sole benefit of the community spouse, as defined under Regulation .10-1B(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The resource was transferred to the person's son or daughter who is blind or disabled as defined under Regulation .05D and E of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>The resource was transferred to the person's spouse, or to another for the sole benefit of the person's spouse, if the spouse does not transfer the resource to another person for less than fair market value;</text> </paragraph> <paragraph num="(d)"> <text>The person furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the person intended to dispose of the resource at fair market value or for other valuable consideration;</text> </paragraph> <paragraph num="(e)"> <text>The person furnishes convincing evidence that the resource was transferred exclusively for a purpose other than to qualify for Medical Assistance; or</text> </paragraph> <paragraph num="(f)"> <text>The Department determines that the denial of eligibility would work an undue hardship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>A unit shall be ineligible for any month in which countable resources exceed the applicable standard, but may reapply for any following month in which countable resources are less than or equal to the applicable standard.</text> </paragraph> <paragraph num="M."> <text>Schedule MA-2.</text> </paragraph> <paragraph num="N."> <text>Schedule MA-2A.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-1" heading="Disposal of Assets for Less Than Fair Market Value."> <paragraph num="A."> <text>Definitions. In this regulation, the following terms have the meanings indicated:</text> <paragraph num="(1)"> <text>“Assets” means all income and resources of an individual and of an individual's spouse, including any income or resources which the individual or the individual's spouse is entitled to but does not receive because of action by:</text> <paragraph num="(a)"> <text>The individual;</text> </paragraph> <paragraph num="(b)"> <text>The individual's spouse;</text> </paragraph> <paragraph num="(c)"> <text>A person, including a court or administrative body:</text> <paragraph num="(i)"> <text>With legal authority to act in place of or on behalf of the individual or the individual's spouse, or</text> </paragraph> <paragraph num="(ii)"> <text>Acting at the direction or upon the request of the individual or the individual's spouse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Trust” means a legal instrument, which is either revocable or irrevocable, created, other than by will, by a grantor for the benefit of designated beneficiaries under the laws of the State and subject to the management of a trustee or trustees who have a fiduciary responsibility to manage the trust's resources and income for the benefit of the beneficiaries.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposal of Assets.</text> <paragraph num="(1)"> <text>In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of assets disposed of after August 10, 1993, a penalty period shall be established during which an individual is determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for home and community-based waiver services provided for under the authority of §1915(c) and (d) of the Social Security Act if the individual or the individual's spouse disposes of an asset for less than fair market value at any time during or after the time periods specified under §B(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Time Periods for Evaluating Disposals.</text> <paragraph num="(a)"> <text>For assets other than trusts, the time period for evaluating disposals is the following:</text> <paragraph num="(i)"> <text>For disposals earlier than February 6, 2006, the 36-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance.</text> </paragraph> <paragraph num="(ii)"> <text>For disposals on or after February 6, 2006, the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In the case of payments from a trust or portions of a trust that are treated as a disposal of assets under Regulation .08-2B(4)(c), (5)(a)(ii), or (5)(b) of this chapter, the time period for evaluating disposals is the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The penalty period begins:</text> <paragraph num="(a)"> <text>For a transfer before February 6, 2006, with the later of:</text> <paragraph num="(i)"> <text>The first day of the month in which the asset was transferred; or</text> </paragraph> <paragraph num="(ii)"> <text>The date on which the individual is eligible for Medical Assistance and, but for the transfer, would be receiving institutional level of care; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a transfer on or after February 6, 2006, with the later of:</text> <paragraph num="(i)"> <text>The first day of the month in which the individual is eligible for Medicaid and would be receiving Medicaid nursing facility services but for the application of this penalty; or</text> </paragraph> <paragraph num="(ii)"> <text>The month during or after which assets have been transferred for less than fair market value.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the transfer occurs while the individual is in a penalty period for an earlier disposal, the penalty period begins on the first day of the first month following the end of the earlier penalty period.</text> </paragraph> <paragraph num="(5)"> <text>The number of months in the penalty period are equal to the total, cumulative, uncompensated value of all assets transferred, divided by the average monthly cost, to a private patient at the time of application for Medical Assistance, of nursing facility services in the State.</text> </paragraph> <paragraph num="(6)"> <text>Asset Transfers For Less Than Average Monthly Cost of Care.</text> <paragraph num="(a)"> <text>If the amount of a transfer is less than the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred.</text> </paragraph> <paragraph num="(b)"> <text>If a series of transfers is made, each of which is less than the average monthly cost of nursing facility services, the penalty period is calculated based on the total, cumulative, uncompensated value of all assets transferred.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Transfers Not Equally Divisible. If the amount of a single transfer or the amount of the total, cumulative, uncompensated value of all assets transferred is not equally divisible by the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred.</text> </paragraph> <paragraph num="(8)"> <text>An institutionalized individual may not be determined ineligible for Medical Assistance under §B(1) of this regulation if the asset transferred was a home, and title to the home was transferred to:</text> <paragraph num="(a)"> <text>The spouse of the individual;</text> </paragraph> <paragraph num="(b)"> <text>The individual’s child as defined under Regulation .02B of this chapter or who is blind or disabled as determined under Regulation .05-4 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>A sibling of the individual who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the individual became an institutionalized individual; or</text> </paragraph> <paragraph num="(d)"> <text>A son or daughter of the individual other than the individual’s child described under §B(8)(b) of this regulation, who:</text> <paragraph num="(i)"> <text>Is lawfully residing in the home,</text> </paragraph> <paragraph num="(ii)"> <text>Was residing in the home for a period of at least 2 years immediately before the date the individual became an institutionalized individual, and</text> </paragraph> <paragraph num="(iii)"> <text>Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the individual to reside at home rather than in an institution.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>An individual may not be determined ineligible for Medical Assistance by reason of the transfer of any asset, excluded or countable, if the asset was transferred under one of the following conditions:</text> <paragraph num="(a)"> <text>The asset was transferred to the individual's spouse or to another for the sole benefit of the individual's spouse;</text> </paragraph> <paragraph num="(b)"> <text>The asset was transferred from the individual's spouse to another for the sole benefit of the individual's spouse;</text> </paragraph> <paragraph num="(c)"> <text>The asset was transferred to, or to a trust established for the sole benefit of, the individual’s son or daughter who is blind or disabled as defined under Regulation .05-4 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>The asset was transferred to a trust established for the sole benefit of a disabled individual, as defined under Regulation .05-4B of this chapter, younger than 65 years old;</text> </paragraph> <paragraph num="(e)"> <text>The individual furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the individual intended to dispose of the asset at fair market value or for other valuable consideration;</text> </paragraph> <paragraph num="(f)"> <text>The individual furnishes convincing evidence that the asset was transferred exclusively for a purpose other than to qualify for Medical Assistance; or</text> </paragraph> <paragraph num="(g)"> <text>The full value of the asset transferred by an individual for less than fair market value has been returned to the individual.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>In the case of an asset held by an individual in common with another individual or individuals in a joint tenancy, tenancy in common, or similar arrangement, the asset, or the affected portion of the asset, shall be considered a transfer when any action is taken, either by the individual or by any other individual, that reduces or eliminates the individual's ownership or control of the asset.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-2" heading="Treatment of Trust Amounts."> <paragraph num="A."> <text>For the purpose of this regulation, “trust” has the meaning defined under Regulation .08-1A of this chapter.</text> </paragraph> <paragraph num="B."> <text>Treatment of Trusts Established after August 10, 1993.</text> <paragraph num="(1)"> <text>In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of trusts established after August 10, 1993, an individual shall be considered to have established a trust if assets of the individual as defined under Regulation .08-1A of this chapter were used to form all or part of the corpus of the trust and if any of the following persons established the trust other than by will:</text> <paragraph num="(a)"> <text>The individual;</text> </paragraph> <paragraph num="(b)"> <text>The individual's spouse;</text> </paragraph> <paragraph num="(c)"> <text>A person, including a court or administrative body:</text> <paragraph num="(i)"> <text>With legal authority to act in place of or on behalf of the individual or the individual's spouse, or</text> </paragraph> <paragraph num="(ii)"> <text>Acting at the direction or upon the request of the individual or the individual's spouse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the case of a trust, the corpus of which includes assets of one of the individuals described under §B(1)(a) or (b) of this regulation and assets of any other individual or individuals, the provisions of this regulation apply to the portion of the trust attributable to the assets of the individual described under §B(1)(a) or (b) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The provisions of this regulation apply without regard to:</text> <paragraph num="(a)"> <text>The purposes for which a trust is established;</text> </paragraph> <paragraph num="(b)"> <text>Whether the trustees have or exercise any discretion under the trust;</text> </paragraph> <paragraph num="(c)"> <text>Restrictions on when or whether distributions may be made from the trust; or</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on the use of distributions from the trust.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Revocable Trusts. In the case of a revocable trust:</text> <paragraph num="(a)"> <text>The corpus of the trust shall be considered resources available to the individual;</text> </paragraph> <paragraph num="(b)"> <text>Payments from the trust to, or for the benefit of, the individual shall be considered income of the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Other payments from the trust shall be considered assets disposed of by the individual.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Irrevocable Trust. In the case of an irrevocable trust, if there are any circumstances under which payment from the trust could be made to or for the benefit of the individual:</text> <paragraph num="(a)"> <text>The portion of the corpus from which, or the income on the corpus from which, payment to the individual could be made shall be considered resources available to the individual, and payments from that portion of the corpus or income:</text> <paragraph num="(i)"> <text>To or for the benefit of the individual, shall be considered income of the individual, and</text> </paragraph> <paragraph num="(ii)"> <text>For any other purpose, shall be considered a transfer of assets; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A portion of the trust from which, or any income on the corpus from which, a payment could not, under any circumstances, be made to the individual shall be considered to be assets disposed of by the individual, as of the date of establishment of the trust or, if later, the date on which payment to the individual was foreclosed. The value of the trust shall be determined, for purposes of evaluating the disposal, by including the amount of any payments made from that portion of the trust after the date of establishment or foreclosure.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The following trusts may not be counted in determining eligibility for Medical Assistance:</text> <paragraph num="(a)"> <text>Special needs trusts as defined in §C of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>A pooled special needs trust containing the assets of an individual who is disabled, and which meets all of the following conditions:</text> <paragraph num="(i)"> <text>The trust is established and managed by a nonprofit association,</text> </paragraph> <paragraph num="(ii)"> <text>A separate account is maintained for each beneficiary of the trust but, for purposes of investment and management of funds, the trust pools these accounts,</text> </paragraph> <paragraph num="(iii)"> <text>Accounts in the trust are established solely for the benefit of disabled individuals by the parent, grandparent, or legal guardian of the individuals, by the individuals, or by a court, and</text> </paragraph> <paragraph num="(iv)"> <text>To the extent that amounts remaining in the beneficiary's account upon the death of the beneficiary are not retained by the trust, the trust pays to the Department from the amounts remaining in the account an amount equal to the total amount of Medical Assistance paid on behalf of the beneficiary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>A nonprofit association that establishes and manages a trust consistent with the requirements of §B(6)(b) of this regulation may establish accounts for individuals for whom no governmental entity has made a determination of disability, provided that:</text> <paragraph num="(a)"> <text>The beneficiary of the account has submitted, or is actively engaged in preparing to submit, an application to:</text> <paragraph num="(i)"> <text>The Social Security Administration for Supplemental Security Income or Social Security Disability Insurance; or</text> </paragraph> <paragraph num="(ii)"> <text>The Department of Human Services State Review Team for a disability determination using the Social Security Administration rules; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The account is closed immediately upon a determination, exclusive of appeals, by any State or federal governmental agency that the beneficiary of the account is not disabled.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Special Needs Trust. The following criteria shall define a single, stand-alone special needs trust that is funded with assets that belonged to the beneficiary:</text> <paragraph num="(1)"> <text>The trust is irrevocable;</text> </paragraph> <paragraph num="(2)"> <text>The trust states that the beneficiary is disabled under Regulation .05-4B of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>The beneficiary of the trust is younger than 65 years old at the time the trust is established and funded;</text> </paragraph> <paragraph num="(4)"> <text>The trust has been established by:</text> <paragraph num="(a)"> <text>The beneficiary;</text> </paragraph> <paragraph num="(b)"> <text>The beneficiary’s parent;</text> </paragraph> <paragraph num="(c)"> <text>The beneficiary’s grandparent;</text> </paragraph> <paragraph num="(d)"> <text>The beneficiary’s legal guardian; or</text> </paragraph> <paragraph num="(e)"> <text>A court;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The trust does not contain provisions that conflict with the policies set forth under this regulation;</text> </paragraph> <paragraph num="(6)"> <text>The trust provides that all states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust upon the death of the beneficiary;</text> </paragraph> <paragraph num="(7)"> <text>If the trust allows for the termination of the trust before the death of the beneficiary, the trust shall provide that:</text> <paragraph num="(a)"> <text>All states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust at the time of termination, after administrative expenses related to the termination of the trust;</text> </paragraph> <paragraph num="(b)"> <text>Other than amounts paid to the states under §C(7)(a) of this regulation and payment of administrative expenses and reasonable compensation to the trustee for trust management, along with reasonable costs associated with investment, legal, or other services, no entity other than the trust beneficiary may benefit from early termination of the trust; and</text> </paragraph> <paragraph num="(c)"> <text>The power to terminate shall be held by someone other than the trust beneficiary;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The trust does not permit distribution of trust assets upon termination of the trust that would hinder or delay reimbursement to the states under §C(6) and (7) of this regulation;</text> </paragraph> <paragraph num="(9)"> <text>The trust does not place time limits, or any other limits, on the states’ claim for reimbursement under §C(6) and (7) of this regulation;</text> </paragraph> <paragraph num="(10)"> <text>The trust contains the following provisions:</text> <paragraph num="(a)"> <text>Additions may not be made to the trust after the beneficiary is 65 years old;</text> </paragraph> <paragraph num="(b)"> <text>Expenditures from the trust shall be used for the sole benefit of the beneficiary and shall be directly related to the beneficiary's health care, education, comfort, or support;</text> </paragraph> <paragraph num="(c)"> <text>The trust beneficiary may not serve as trustee, cotrustee, trust protector, trust advisor, or in any other capacity that would allow the beneficiary to influence or exercise authority or control over distributions from the trust;</text> </paragraph> <paragraph num="(d)"> <text>The trustee shall administer the trust in accordance with the provisions of Estates and Trusts Article, §15-502, Annotated Code of Maryland, and may not:</text> <paragraph num="(i)"> <text>Except for the beneficiary’s relative, limited to the relatives defined at COMAR 10.09.24.02B(10)(a), who may have a contingent future interest in any trust funds remaining in the trust after the requirements of §C(6) of this regulation have been met, have an interest in trust assets;</text> </paragraph> <paragraph num="(ii)"> <text>Have discretion to use trust assets for the trustee's own benefit;</text> </paragraph> <paragraph num="(iii)"> <text>Self-deal by selling trust assets to the trustees or buying trust assets from the trustee; or</text> </paragraph> <paragraph num="(iv)"> <text>Loan trust assets to the trustee;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Compensation to the trustee shall be limited in accordance with the provisions of Estates and Trusts Article, §14.5-708, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>Any leases or mortgages that the trust may hold shall contain a provision that they either terminate or become due and payable upon the death of the beneficiary or termination of the trust;</text> </paragraph> <paragraph num="(g)"> <text>If the trust owns titled property that is valued at more than $500, the property shall be titled in the name of the trust, except for securities, which may be held in the name of a nominee;</text> </paragraph> <paragraph num="(h)"> <text>If the trust owns an asset jointly with another, the ownership shall be as tenants in common, and the ownership agreement shall provide that, upon termination of the trust, the property shall either be sold for fair market value or the other owners shall purchase the trust's interest in the property for fair market value;</text> </paragraph> <paragraph num="(i)"> <text>Trust assets may not be held as an ongoing business or enterprise, or as investments in new or untried enterprises;</text> </paragraph> <paragraph num="(j)"> <text>Trust distributions may not be used to supplement Medical Assistance payments to any health care provider delivering goods or services to the beneficiary;</text> </paragraph> <paragraph num="(k)"> <text>Trust assets may not be used to purchase gifts;</text> </paragraph> <paragraph num="(l)"> <text>Trust assets may not be used to purchase a life insurance policy on the life of the beneficiary;</text> </paragraph> <paragraph num="(m)"> <text>Trust assets may only be used to purchase a life insurance policy on the life of someone other than the trust beneficiary if the trust is the only beneficiary of the life insurance policy;</text> </paragraph> <paragraph num="(n)"> <text>Trust assets may not be used to purchase an annuity on the life of the beneficiary unless, upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states.</text> </paragraph> <paragraph num="(o)"> <text>The trust may not loan trust assets without security, which may include an interest in real or personal property of at least equivalent value;</text> </paragraph> <paragraph num="(p)"> <text>The trust may only make loans if the loan agreement provides for immediate repayment in the event of the death of the beneficiary or termination of the trust for any other reason;</text> </paragraph> <paragraph num="(q)"> <text>The only real property in which the trust may invest is in a single home property, which is used as the residence of the beneficiary and is titled in the name of the trust;</text> </paragraph> <paragraph num="(r)"> <text>The trust may not disburse more than $100,000 for the purchase of property without the approval of the State circuit court in the jurisdiction in which the beneficiary resides;</text> </paragraph> <paragraph num="(s)"> <text>An annual accounting of the trust, including a listing of current assets, income, and itemized distributions during the previous year, shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services;</text> </paragraph> <paragraph num="(t)"> <text>Trust assets may not be used to pay funeral expenses of the beneficiary but may be used to purchase an irrevocable burial contract for the beneficiary to cover the beneficiary's funeral and burial expenses;</text> </paragraph> <paragraph num="(u)"> <text>The trust may not receive payments from a structured settlement or an annuity that was purchased by funds that are not part of the trust unless:</text> <paragraph num="(i)"> <text>Upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity or settlement payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states; and</text> </paragraph> <paragraph num="(ii)"> <text>The beneficiary’s right to receive payments from the annuity or structured settlement has been assigned irrevocably to the trust and such assignment was made before the trust beneficiary attains the age of 65;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>A copy of the trust shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services, and if any amendments are made to the trust, the amendments shall comply with this section and a copy of the amendments shall be sent to the Division of Recoveries and Financial Services;</text> </paragraph> <paragraph num="(12)"> <text>If the trust agreement fails to comply with any provision of this section, the full value of the assets of the trust shall be considered available resources of the trust beneficiary for Medical Assistance eligibility purposes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-3" heading="Resource Consideration of Entrance Fees for Continuing Care Retirement Communities."> <paragraph num="A."> <text>Treatment of Entrance Fees before January 1, 2006. For Medical Assistance applications or requests for spousal resource assessments filed before January 1, 2006, the entrance fee shall be considered in accordance with the policies for exclusion of home property in this chapter.</text> </paragraph> <paragraph num="B."> <text>Treatment of Entrance Fees On or After January 1, 2006.</text> <paragraph num="(1)"> <text>For Medical Assistance applications or requests for spousal resource assessments filed on or after January 1, 2006, an entrance fee shall be considered available to the owner as a countable resource if the CCRC provides written verification, based on CCRC practice or policy, which satisfies the Department that all of the following criteria are met:</text> <paragraph num="(a)"> <text>The applicant or recipient or a designated beneficiary is eligible for a full refund of any amount remaining in the entrance fee, after subtracting any payments or transfers made by the individual in accordance with §B(1)(c)—(e) of this regulation, when the individual:</text> <paragraph num="(i)"> <text>Dies; or</text> </paragraph> <paragraph num="(ii)"> <text>Terminates the continuing care agreement and leaves the CCRC facility;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The entrance fee does not confer on the applicant or recipient a real property interest in the CCRC facility, in which case the entrance fee would be considered as excludable home property;</text> </paragraph> <paragraph num="(c)"> <text>The applicant or recipient has the ability to obtain funds from the entrance fee, without moving from the CCRC facility, to pay the CCRC or another entity for support and maintenance if the individual's income and other resources are insufficient to pay for the support and maintenance;</text> </paragraph> <paragraph num="(d)"> <text>If the Medical Assistance applicant or recipient has a son or daughter who is blind or disabled as defined under this chapter, the applicant or recipient has the ability to transfer unconditionally all or part of the entrance fee to the individual's blind or disabled son or daughter; and</text> </paragraph> <paragraph num="(e)"> <text>If the Medical Assistance applicant or recipient is institutionalized and married to a community spouse the:</text> <paragraph num="(i)"> <text>CCRC's entrance fee, if it is considered a countable resource in accordance with the requirements in §B of this regulation, shall be included in the assessment for the attribution of spousal resources, in accordance with Regulation .10-1 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>CCRC shall permit the recipient to transfer unconditionally all or part of the entrance fee to the sole ownership of the community spouse according to the amount that is needed, after totaling other resources owned singly or jointly by the couple, for the community spouse resource allowance to total the protected amount calculated by the Department, in accordance with Regulation .10-1 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall grant the applicant or recipient the opportunity to rebut the CCRC's written verification that all of the conditions in §B of this regulation are met for consideration of the entrance fee as a countable resource.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant or recipient submits a rebuttal to the Department, the Department shall request additional documentation and evidence from the CCRC that support the basis for the CCRC's written verification of the availability of the entrance fee.</text> </paragraph> <paragraph num="(4)"> <text>The entrance fee may not be considered as a countable resource for determining the applicant's or recipient's Medical Assistance eligibility if the:</text> <paragraph num="(a)"> <text>Requirements in §B(1) of this regulation are not met;</text> </paragraph> <paragraph num="(b)"> <text>CCRC imposes limitations, conditions, penalties, or otherwise restricts the individual's right to reside in the CCRC facility when the individual uses funds from the entrance fee to make payments or transfers in accordance with §B(1)(c) — (e) of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>Applicant or recipient successfully rebuts, as determined by the Department in accordance with §B(2) of this regulation, the CCRC's written verification that all of the conditions in §B(1) of this regulation are met.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-4" heading="Resource Consideration of Long-Term Care Partnership Policies."> <paragraph num="A."> <text>This regulation establishes the rules for applicants and recipients who:</text> <paragraph num="(1)"> <text>Own a long-term care (LTC) partnership policy; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all factors of Medicaid eligibility in accordance with MAGI Exempt coverage groups described in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Defined Terms.</text> <paragraph num="(a)"> <text>“Benefit payment amount” means the dollar value of LTC benefits which an insurance carrier has furnished on behalf of a partnership policyholder and which is disregarded from the resource amount when determining eligibility.</text> </paragraph> <paragraph num="(b)"> <text>“Insurance carrier” means an insurer who issues an insurance policy and makes benefit payment amounts on behalf of a partnership policyholder.</text> </paragraph> <paragraph num="(c)"> <text>“Partnership policy” means a LTC insurance policy that meets the requirements as described under COMAR 31.14.03.02 and whose benefit payment amount is disregarded from the resource amount when determining eligibility.</text> </paragraph> <paragraph num="(d)"> <text>“Partnership policyholder” means an individual who owns a partnership policy under the federal LTC partnership program.</text> </paragraph> <paragraph num="(e)"> <text>“Reciprocity compact” means an agreement among states having partnership programs that are approved under section 6021(b) of the Deficit Reduction Act of 2005, Public Law 109-171 (DRA).</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Partnership Policyholder Requirements.</text> <paragraph num="(1)"> <text>An applicant or recipient shall meet all factors of Medicaid eligibility in accordance with rules for MAGI Exempt coverage groups set forth in this chapter.</text> </paragraph> <paragraph num="(2)"> <text>An applicant or recipient shall have:</text> <paragraph num="(a)"> <text>A Maryland partnership policy approved on or after January 1, 2009, that meets all certification requirements, as described in COMAR 31.14.03; or</text> </paragraph> <paragraph num="(b)"> <text>A partnership policy approved in another state that has joined the national reciprocity compact under the federal LTC partnership program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant or recipient shall provide documentation of the partnership policy benefit payments that have been issued by an insurance carrier.</text> </paragraph> <paragraph num="(4)"> <text>Subject to Regulation .10-2E of this chapter, an applicant or recipient who applies for LTC Medical Assistance in a nursing facility or through a waiver program shall be ineligible for payment for nursing facility services, or services under a home and community based waiver program, when the individual’s equity interest in home property exceeds the maximum allowable home equity amount as set forth in Regulation .10-2 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Eligibility Determination for a Partnership Policyholder.</text> <paragraph num="(1)"> <text>When determining the resources of an individual in accordance with Regulation .08 of this chapter, there shall be disregarded a dollar value equal to the benefit payment amount.</text> </paragraph> <paragraph num="(2)"> <text>The benefit payment amount for purposes of the disregard set forth in §D(1) of this regulation shall:</text> <paragraph num="(a)"> <text>For purposes of initial application, equal the dollar amount of benefits paid to or on behalf of the partnership beneficiary at the time of application; and</text> </paragraph> <paragraph num="(b)"> <text>For purposes of redetermination, equal the benefit payment amount in §D(2)(a) of this regulation and the value of any additional benefits paid to or on behalf of the partnership beneficiary up to the time of redetermination, until all benefits under the partnership policy are exhausted.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At the time of application and at each redetermination, the Department shall request documentation of the benefit payment amount.</text> </paragraph> </paragraph> <paragraph num="E."> <text>With the exception of an amount equal in value to the benefit payment amount applied at the most recent redetermination period, partnership policyholders will continue to be subject to a penalty for asset transfers for less than fair market value in accordance with Regulation .08 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Estate recovery by the Department is limited as set forth in Regulation .15A-3(5) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Determining Financial Eligibility for Noninstitutionalized Individuals."> <paragraph num="A."> <text>Basis.</text> <paragraph num="(1)"> <text>Financial eligibility is determined on the basis of the countable net income and resources of members of the MAGI exempt assistance unit and those individuals whose income and resource are considered pursuant to Regulations .06, .07, and .08 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established.</text> </paragraph> <paragraph num="(2)"> <text>The appropriate medically needy income level shall be the amount specified in Schedule MA-1 for the number of persons whose income is considered in determining financial eligibility.</text> </paragraph> <paragraph num="(3)"> <text>The appropriate medically needy resource level shall be the amount specified in Schedule MA-2 for the number of persons whose resources are considered in determining financial eligibility.</text> </paragraph> <paragraph num="(4)"> <text>Financial eligibility is determined on the basis of the countable income for members of the MAGI household unit and those individuals whose income are considered pursuant to Regulations .06-1 and .07 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Retroactive Eligibility.</text> <paragraph num="(1)"> <text>When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy.</text> </paragraph> <paragraph num="(2)"> <text>When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, retroactive eligibility may exist under the spend-down provision as specified in §B(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Excess Resources. Retroactive eligibility does not exist when the countable resources are greater than the medically needy resource level.</text> </paragraph> <paragraph num="(4)"> <text>Retroactive Spend-Down Eligibility.</text> <paragraph num="(a)"> <text>In determining retroactive spend-down eligibility, documented medical and remedial expenses incurred during the 3 months before the month of application of any person whose income and resources are considered in determining eligibility shall be considered if the incurred expenses:</text> <paragraph num="(i)"> <text>Have not been paid for by any third party, including a family member or an insurer; and</text> </paragraph> <paragraph num="(ii)"> <text>Are not required to be paid for by any third party, such as an insurer.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess income in the following order:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles, or coinsurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan;</text> </paragraph> <paragraph num="(iii)"> <text>Expenses incurred for necessary medical care or remedial services that are covered under the State Plan.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Retroactive spend-down eligibility is established when the incurred medical expenses exceed the excess income.</text> </paragraph> <paragraph num="(d)"> <text>The medical expense used to establish retroactive spend-down eligibility may not be:</text> <paragraph num="(i)"> <text>Reimbursed by the Medical Assistance Program; or</text> </paragraph> <paragraph num="(ii)"> <text>Used for any subsequent eligibility determination.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Retroactive spend-down eligibility is not established when the incurred medical expenses are equal to or less than the excess income.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Current Eligibility.</text> <paragraph num="(1)"> <text>When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy.</text> </paragraph> <paragraph num="(2)"> <text>When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, eligibility may exist under the spend-down provision as specified in §C(4) of this regulation. Spend-down eligibility is established when the amount of the incurred medical expenses equals or exceeds the excess income.</text> </paragraph> <paragraph num="(3)"> <text>Excess Resources. Eligibility does not exist when the countable resources are greater than the medically needy resource level.</text> </paragraph> <paragraph num="(4)"> <text>Spend-Down Eligibility.</text> <paragraph num="(a)"> <text>In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in §C(4)(b)—(d) of this regulation shall be considered.</text> </paragraph> <paragraph num="(b)"> <text>Medical expenses incurred before the month of application shall be considered if:</text> <paragraph num="(i)"> <text>The expenses were not considered in any retroactive certification;</text> </paragraph> <paragraph num="(ii)"> <text>The expenses were not used to establish spend-down eligibility for a prior certification; and</text> </paragraph> <paragraph num="(iii)"> <text>The expenses are not paid for by any other person, remain the obligation of the person whose income and resources are considered in determining eligibility, and have not been forgiven by the provider of the services as evidenced by account statements dating up to 3 months before the month of application.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration by any person whose income and resources are considered in determining eligibility shall be considered if the medical expenses:</text> <paragraph num="(i)"> <text>Have not been paid for by any third party, including a family member or an insurer; and</text> </paragraph> <paragraph num="(ii)"> <text>Are not required to be paid for by any third party, such as an insurer.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase.</text> </paragraph> <paragraph num="(e)"> <text>Medical expenses incurred during the time periods specified in §C(4)(b) and (c) of this regulation shall be deducted from the excess income beginning with the earliest time period and in the following order:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles, or coinsurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan;</text> </paragraph> <paragraph num="(iii)"> <text>Expenses incurred for necessary medical care or remedial services that are covered under the State Plan.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Spend-down eligibility is established for the remainder of the period under consideration when the incurred medical expenses equal or exceed the amount of excess income. The medical expenses used to establish spend-down eligibility may not be:</text> <paragraph num="(i)"> <text>Reimbursed by the Medical Assistance Program; or</text> </paragraph> <paragraph num="(ii)"> <text>Used for any subsequent eligibility determination.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration.</text> </paragraph> <paragraph num="(h)"> <text>When the incurred medical expenses do not equal the amount of excess income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Determining Financial Eligibility for Institutionalized Persons."> <paragraph num="A."> <text>Scope.</text> <paragraph num="(1)"> <text>This section applies to persons who are institutionalized throughout a calendar month.</text> </paragraph> <paragraph num="(2)"> <text>Institutional status is presumed to begin on the first day of the first full calendar month in which the person is institutionalized and ends on the last day of the last full calendar month before discharge.</text> </paragraph> <paragraph num="(3)"> <text>Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer from a long-term-care facility to a hospital.</text> </paragraph> <paragraph num="(4)"> <text>Presumed institutional status changes on the first day of the month of discharge to the community.</text> </paragraph> <paragraph num="(5)"> <text>Eligibility for noninstitutionalized persons shall be determined separately under Regulation .09 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Basis.</text> <paragraph num="(1)"> <text>Financial eligibility shall be determined on the basis of the countable resources and income of members of the assistance unit.</text> </paragraph> <paragraph num="(2)"> <text>A person is categorically needy if his total income before deductions does not exceed 300 percent of the current SSI payment standard and his countable resources are within the applicable amount in Schedule MA-2A.</text> </paragraph> <paragraph num="(3)"> <text>A person is medically needy if his total income before deductions exceeds 300 percent of the SSI payment standard or if countable resources exceed the applicable amount in Schedule MA-2A.</text> </paragraph> <paragraph num="(4)"> <text>When calculating an institutionalized recipient's available income for the cost-of-care in a long-term care facility, in accordance with Regulations .10 and .10-1 of this chapter, guardianship fees may not be allowed as an income deduction, whether or not the recipient has a community spouse.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Retroactive Eligibility.</text> <paragraph num="(1)"> <text>A retroactive eligibility determination shall be made for services incurred by an institutionalized person within 3 months before the month of application. Eligibility will be considered only for the month, or months, in which the expenses were incurred.</text> </paragraph> <paragraph num="(2)"> <text>The period under consideration shall be the month, or months, for which coverage is requested.</text> </paragraph> <paragraph num="(3)"> <text>Excess Resources. When the countable resources are greater than the medically needy resource standard, retroactive eligibility does not exist.</text> </paragraph> <paragraph num="(4)"> <text>Determination of Available Income for the Retroactive Period. The following amounts shall be deducted from the total income in the following order:</text> <paragraph num="(a)"> <text>For dates of service beginning July 1, 2003, a personal needs allowance of:</text> <paragraph num="(i)"> <text>$50 a month for an institutionalized person other than a person who meets the requirements of §C(4)(a)(iii) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>$100 a month for an institutionalized couple.</text> </paragraph> <paragraph num="(iii)"> <text>$100 a month for a person who resided in an ICF/IID or mental hospital, participated in therapeutic work activities, and received remuneration for participation in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For dates of service beginning July 1, 2004, a personal needs allowance of:</text> <paragraph num="(i)"> <text>$60 a month for an institutionalized person other than a person who meets the requirements of §C(4)(b)(iii) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>$120 a month for an institutionalized couple; and</text> </paragraph> <paragraph num="(iii)"> <text>$100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living.</text> </paragraph> <paragraph num="(d)"> <text>Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level.</text> </paragraph> <paragraph num="(e)"> <text>Residential Maintenance Allowance for a Single Person.</text> <paragraph num="(i)"> <text>For a person with no spouse or unmarried child younger than 21 years old at home, the amount not to exceed the medically needy income level that was needed to maintain the person's residence during the retroactive period shall be deducted beginning with the person's earliest first full month of institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence and that the person intends to do so.</text> </paragraph> <paragraph num="(ii)"> <text>Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer to a hospital.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Incurred expenses for medical care or remedial service that have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer, including:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles or co-insurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>In the case of eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and</text> </paragraph> <paragraph num="(iii)"> <text>In the case of eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Incurred expenses for necessary medical care or remedial service described under §C(4)(f)(iii) of this regulation as follows:</text> <paragraph num="(i)"> <text>For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and</text> </paragraph> <paragraph num="(ii)"> <text>Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Subject to the requirements of §C(6) of this regulation, effective October 1, 2016, the personal needs allowance set forth in §C(4) of this regulation shall be increased as follows:</text> <paragraph num="(a)"> <text>For a Medicaid recipient who has been assigned a guardian of the person, $50 per month;</text> </paragraph> <paragraph num="(b)"> <text>For a Medicaid recipient who has been assigned a guardian of the property, $50 per month;</text> </paragraph> <paragraph num="(c)"> <text>For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month; and</text> </paragraph> <paragraph num="(d)"> <text>For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §C(4) of this regulation.</text> </paragraph> <paragraph num="(7)"> <text>If the effective date cited in §C(4)(f)(ii) and (iii), and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009.</text> </paragraph> <paragraph num="(8)"> <text>When the available income as determined under §C(4) of this regulation is equal to or less than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility exists and begins on the first day of the period under consideration. Certification is established under Regulation .11D of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>When the available income as determined under §C(4) of this regulation is greater than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility may exist under §C(10) of this regulation.</text> </paragraph> <paragraph num="(10)"> <text>Retroactive Spend-Down Eligibility.</text> <paragraph num="(a)"> <text>In determining retroactive spend-down eligibility, documented medical expenses incurred more than 3 months before the month of the Medical Assistance application shall be considered if the incurred expenses:</text> <paragraph num="(i)"> <text>Have not been paid for by any third party, including a family member or an insurer;</text> </paragraph> <paragraph num="(ii)"> <text>Are not required to be paid for by any third party, such as an insurer;</text> </paragraph> <paragraph num="(iii)"> <text>Were not incurred during a penalty period; and</text> </paragraph> <paragraph num="(iv)"> <text>Were not forgiven by the provider.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess available income in the following order:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles, or co-insurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan;</text> </paragraph> <paragraph num="(iii)"> <text>Expenses incurred for necessary medical care or remedial services that are covered under the State Plan.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The medical expenses used to establish retroactive spend-down eligibility may not be:</text> <paragraph num="(i)"> <text>Reimbursed by the Medical Assistance Program;</text> </paragraph> <paragraph num="(ii)"> <text>Used for any subsequent eligibility determination; or</text> </paragraph> <paragraph num="(iii)"> <text>Incurred before the period for which retroactive eligibility is requested.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Retroactive spend-down eligibility is established on the day the incurred medical expenses considered under §C(10)(b) of this regulation equal or exceed the excess available income. Certification is established under Regulation .11D of this chapter.</text> </paragraph> <paragraph num="(e)"> <text>Retroactive spend-down eligibility is not established when the incurred medical expenses are less than the excess available income.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Current Eligibility.</text> <paragraph num="(1)"> <text>Excess Resources. When the countable resources are greater than the medically needy resource level, eligibility does not exist.</text> </paragraph> <paragraph num="(2)"> <text>Determination of Available Income. The following amounts shall be deducted from total income in the following order:</text> <paragraph num="(a)"> <text>For dates of service beginning July 1, 2003, a personal needs allowance of:</text> <paragraph num="(i)"> <text>$50 a month for an institutionalized person other than a person who meets the requirements of §D(2)(a)(iii) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>$100 a month for an institutionalized couple.</text> </paragraph> <paragraph num="(iii)"> <text>$100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and receives remuneration for participating in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For dates of service beginning July 1, 2004, a personal needs allowance of:</text> <paragraph num="(i)"> <text>$60 a month for an institutionalized person other than a person who meets the requirements of §D(2)(b)(iii) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>$120 a month for an institutionalized couple; and</text> </paragraph> <paragraph num="(iii)"> <text>$100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living.</text> </paragraph> <paragraph num="(d)"> <text>Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level.</text> </paragraph> <paragraph num="(e)"> <text>Residential Maintenance Allowance for a Single Person.</text> <paragraph num="(i)"> <text>For a person with no spouse or unmarried child younger than 21 years old at home, an amount not to exceed the medically needy income level needed to maintain the person's residence during institutionalization shall be deducted for a period of up to 6 months beginning with the person's first full month of current institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence during this period and that person intends to do so.</text> </paragraph> <paragraph num="(ii)"> <text>The maximum 6-month period is not interrupted by a transfer from one long-term care facility to another or by admission to a hospital.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The following incurred medical expenses that are not subject to payment by a third party:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles or co-insurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>For eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and</text> </paragraph> <paragraph num="(iii)"> <text>For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Incurred expenses for necessary medical care or remedial service described under §D(2)(f)(iii) of this regulation as follows:</text> <paragraph num="(i)"> <text>For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and</text> </paragraph> <paragraph num="(ii)"> <text>Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Subject to the requirements of §D(4) of this regulation, effective October 1, 2016, the personal needs allowance is increased as follows:</text> <paragraph num="(a)"> <text>For a Medicaid recipient who has been assigned a guardian of the person, $50 per month;</text> </paragraph> <paragraph num="(b)"> <text>For a Medicaid recipient who has been assigned a guardian of the property, $50 per month;</text> </paragraph> <paragraph num="(c)"> <text>For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month;</text> </paragraph> <paragraph num="(d)"> <text>For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §D(2) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>If the effective date cited in §D(2)(f)(ii) and (iii) and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009.</text> </paragraph> <paragraph num="(6)"> <text>If, after application of the disregards in §D(2) of this regulation, the person's income equals or is less than the projected cost-of-care, eligibility exists and may begin on the first day of the period under consideration. The amount remaining after application of the disregards in §D(2) of this regulation is available income to be applied to the person's cost-of-care. Certification is established under Regulation .11D of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>If, after application of the disregards in §D(2) of this regulation, the person's income exceeds the projected cost-of-care, eligibility may be established under §D(8) of this regulation.</text> </paragraph> <paragraph num="(8)"> <text>Spend-down Eligibility.</text> <paragraph num="(a)"> <text>In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in this section shall be considered.</text> </paragraph> <paragraph num="(b)"> <text>Medical expenses incurred before the month of application shall be considered if the expenses:</text> <paragraph num="(i)"> <text>Were not considered in any retroactive certification;</text> </paragraph> <paragraph num="(ii)"> <text>Were not used to establish spend-down eligibility for a prior certification;</text> </paragraph> <paragraph num="(iii)"> <text>Have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer;</text> </paragraph> <paragraph num="(iv)"> <text>Were not incurred during a penalty period;</text> </paragraph> <paragraph num="(v)"> <text>Remain the obligation of any person whose income and resources are considered in determining eligibility; and</text> </paragraph> <paragraph num="(vi)"> <text>Have not been forgiven by the provider of the services, as evidenced by account statements dating up to 3 months before the month of application.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration shall be considered if they:</text> <paragraph num="(i)"> <text>Were not paid for by any third party, including a family member or an insurer;</text> </paragraph> <paragraph num="(ii)"> <text>Are not required to be paid for by any third party, such as an insurer;</text> </paragraph> <paragraph num="(iii)"> <text>Were not incurred during a penalty period; and</text> </paragraph> <paragraph num="(iv)"> <text>Have not been forgiven by the provider.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase.</text> </paragraph> <paragraph num="(e)"> <text>Medical expenses incurred during the time periods specified in §D(8)(b) and (c) of this regulation shall be deducted from the excess available income beginning with the earliest time period and in the following order:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles, or co-insurance charges;</text> </paragraph> <paragraph num="(ii)"> <text>Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan;</text> </paragraph> <paragraph num="(iii)"> <text>Expenses incurred for necessary medical care or remedial services that are covered under the State Plan.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Spend-down eligibility is established for the remainder of the period under consideration on the day the incurred medical expenses, considered under §D(8)(e) of this regulation, including projected private cost-of-care obligations, equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter.</text> </paragraph> <paragraph num="(g)"> <text>The medical expenses used to establish spend-down eligibility may not be:</text> <paragraph num="(i)"> <text>Reimbursed by the Medical Assistance Program; or</text> </paragraph> <paragraph num="(ii)"> <text>Used for any subsequent eligibility determination.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Eligibility exists on the day that incurred medical expenses equal or exceed the amount of excess available income.</text> </paragraph> <paragraph num="(i)"> <text>When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration.</text> </paragraph> <paragraph num="(j)"> <text>Eligibility exists on the day during the preserved spend-down period that incurred medical expenses equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter.</text> </paragraph> <paragraph num="(k)"> <text>When the incurred medical expenses do not equal the amount of excess available income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10-1" heading="Treatment of Income and Resources of Certain Institutionalized Spouses."> <paragraph num="A."> <text>Basis.</text> <paragraph num="(1)"> <text>Except as this regulation specifically provides, the provisions of this regulation may not affect:</text> <paragraph num="(a)"> <text>The determination of what constitutes income or resources;</text> </paragraph> <paragraph num="(b)"> <text>The methodology and standards for determining and evaluating income and resources;</text> </paragraph> <paragraph num="(c)"> <text>The criteria and standards for determining financial and nonfinancial eligibility for Medical Assistance; or</text> </paragraph> <paragraph num="(d)"> <text>Any other provision of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In determining the eligibility for Medical Assistance of an institutionalized spouse as defined under §B(6) of this regulation, the provisions of this regulation shall supersede any other provisions of this chapter which are inconsistent with them.</text> </paragraph> <paragraph num="(3)"> <text>Sections D and E of this regulation, which concern the treatment of resources, shall apply to a person who begins a continuous period of institutionalization on or after September 30, 1989. Section C of this regulation, which concerns the treatment of income, shall apply to a person who begins a continuous period of institutionalization before or after September 30, 1989 and who remains institutionalized for a continuous period on or after September 30, 1989. Continuity is broken by absence from an institution for 30 consecutive days.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>“Community spouse” means a person who lives in the community outside an institution and who is married to an institutionalized spouse.</text> </paragraph> <paragraph num="(2)"> <text>“Community spouse monthly income allowance” means the amount by which the minimum monthly maintenance needs allowance established under §C(5) of this regulation exceeds the amount of monthly income otherwise available to the community spouse.</text> </paragraph> <paragraph num="(3)"> <text>“Community spouse resource amount” means the greatest of the amounts under §E(2)(a)—(d) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>“Continuous period of institutionalization” means 30 consecutive days of institutional care in a medical institution or nursing home.</text> </paragraph> <paragraph num="(5)"> <text>“Excess shelter allowance” means the amount by which the sum of the community spouse's expenses for shelter exceeds 30 percent of the amount described under §C(5)(a) of this regulation. Expenses for shelter include rent or mortgage payment, taxes and insurance for the community spouse's principal residence and the standard utility allowance used by the State under §5(e) of the Food Stamp Act of 1977. If the community spouse's principal residence is a condominium or cooperative, the required maintenance charge for the condominium or cooperative shall be included in the sum of the community spouse's expenses for shelter, and the standard utility allowance shall be reduced to the extent the required maintenance charge includes utility expenses.</text> </paragraph> <paragraph num="(6)"> <text>“Family member” means minor or dependent children, dependent parents, or dependent siblings of the institutionalized or community spouse who are residing with the community spouse.</text> </paragraph> <paragraph num="(7)"> <text>“Institutionalized spouse” means a person who is an inpatient in a nursing facility or who is an inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility, whose average length of stay exceeds 30 days and who is married to a person who is not in a medical institution or nursing facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment of Income.</text> <paragraph num="(1)"> <text>Separate Treatment of Income. During any month in which an institutionalized spouse is in the institution, except as provided under §C(2) of this regulation, income of the community spouse may not be deemed available to the institutionalized spouse.</text> </paragraph> <paragraph num="(2)"> <text>Attribution of Income. In determining the income of an institutionalized spouse or community spouse, after the institutionalized spouse has been determined to be eligible for Medical Assistance, the following apply:</text> <paragraph num="(a)"> <text>Non-Trust Property. Except as provided under §C(2)(c) and (d) of this regulation, unless the instrument providing the income otherwise specifically provides, if payment of income is made:</text> <paragraph num="(i)"> <text>Solely in the name of the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse;</text> </paragraph> <paragraph num="(ii)"> <text>In the name of the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and</text> </paragraph> <paragraph num="(iii)"> <text>In the names of the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest or, if payment is made with respect to both spouses and no such interest is specified, 1/2 of the joint interest shall be considered available to each spouse.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Trust Property. In the case of a trust, income shall be considered available to each spouse as provided in the trust or, in the absence of a specific provision in the trust, if payment of income is made:</text> <paragraph num="(i)"> <text>Solely to the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse;</text> </paragraph> <paragraph num="(ii)"> <text>To both the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and</text> </paragraph> <paragraph num="(iii)"> <text>To the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest; or</text> </paragraph> <paragraph num="(iv)"> <text>To both spouses and if the interest is not specified, 1/2 of the joint interest shall be considered available to each spouse.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In the case of income not from a trust in which there is an instrument establishing ownership, except as provided under §C(2)(d) of this regulation, 1/2 of the income shall be considered to be available to the institutionalized spouse and 1/2 to the community spouse.</text> </paragraph> <paragraph num="(d)"> <text>Section C(2)(a) and (c) of this regulation shall be superseded to the extent that an institutionalized spouse can establish, by a preponderance of the evidence, that the ownership interests in income are other than as provided under these sections.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Protecting Income for the Community Spouse. After an institutionalized spouse is determined to be eligible for Medical Assistance, in determining the amount of the spouse's income that is to be applied monthly to payment for the cost of care in the institution, there shall be deducted from the spouse's monthly income the following amounts in the following order:</text> <paragraph num="(a)"> <text>A personal needs allowance of:</text> <paragraph num="(i)"> <text>$50 a month for dates of service beginning July 1, 2003;</text> </paragraph> <paragraph num="(ii)"> <text>$60 a month for dates of service beginning July 1, 2004; and</text> </paragraph> <paragraph num="(iii)"> <text>For dates of service beginning July 1, 2005, an amount adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A community spouse monthly income allowance as defined under §B(2) of this regulation, but only to the extent income of the institutionalized spouse is made available to, or for the benefit of, the community spouse;</text> </paragraph> <paragraph num="(c)"> <text>A family allowance, for each family member defined under §B(5) of this regulation, equal to 1/3 of the amount by which the amount described under §C(5)(a) of this regulation exceeds the amount of the monthly income of that family member; and</text> </paragraph> <paragraph num="(d)"> <text>Incurred expenses for medical care or remedial service for the institutionalized spouse that are not subject to payment by a third party, including:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles or co-insurance charges, and</text> </paragraph> <paragraph num="(ii)"> <text>Necessary medical care or remedial service recognized under the State law but not covered under the State plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Incurred expenses for necessary medical care or remedial service described under §C(3)(d)(ii) of this regulation shall be limited to the fees reimbursed by Medical Assistance which are in effect on the date of service.</text> </paragraph> <paragraph num="(5)"> <text>Establishment of Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance for a community spouse is the sum of:</text> <paragraph num="(a)"> <text>The applicable percent, described under §C(6) of this regulation, of 1/12 of the income official poverty line for a family unit of two members; and</text> </paragraph> <paragraph num="(b)"> <text>An excess shelter allowance as defined under §B(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Applicable Percent. For purposes of §C(5)(a) of this regulation, the applicable percent, effective as of the following dates, is:</text> <paragraph num="(a)"> <text>September 30, 1989, 122 percent;</text> </paragraph> <paragraph num="(b)"> <text>July 1, 1991, 133 percent; and</text> </paragraph> <paragraph num="(c)"> <text>July 1, 1992, 150 percent.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Cap on Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance established under §C(5) of this regulation may not exceed $1,500, subject to adjustment under §G of this regulation, except as provided under §F(3) of this regulation.</text> </paragraph> <paragraph num="(8)"> <text>Court Ordered Support. If a court has entered an order against an institutionalized spouse for monthly income for the support of the community spouse, the community spouse monthly income allowance as defined under §B(2) of this regulation shall be not less than the amount of the monthly income ordered.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Treatment of Resources.</text> <paragraph num="(1)"> <text>Computation of Spousal Share at the Time of Institutionalization.</text> <paragraph num="(a)"> <text>Total Joint Resources. There shall be computed, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse:</text> <paragraph num="(i)"> <text>The total value of the resources to the extent either the institutionalized spouse or the community spouse has an ownership interest;</text> </paragraph> <paragraph num="(ii)"> <text>A spousal share which is equal to 1/2 of the total value.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Assessment. At the request of an institutionalized spouse or community spouse, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse and upon receipt of the relevant documentation of resources, the Department shall:</text> <paragraph num="(i)"> <text>Promptly assess and document the total value of the resources;</text> </paragraph> <paragraph num="(ii)"> <text>Provide a copy of the assessment and documentation to each spouse; and</text> </paragraph> <paragraph num="(iii)"> <text>Retain a copy of the assessment for use under this regulation.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Request for Assessment When Not Part of the Medical Assistance Application. If the request is not part of an application for Medical Assistance, the Department may not include a notice indicating that the spouse has the right to a fair hearing as provided for under §F(1)(c) of this regulation, but shall require payment of a fee not to exceed the reasonable expense of providing and documenting the assessment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Attribution of Resources at the Time of Initial Eligibility Determination. In determining the resources of an institutionalized spouse at the time of application for benefits under this chapter, regardless of any State laws relating to community property or the division of marital property, all the resources held by either the institutionalized spouse, the community spouse, or both, shall be considered to be available to the institutionalized spouse, but only to the extent that the amount of the resources exceeds the greatest of the amounts computed under §E(2)(a)—(d) of this regulation at the time of application for benefits.</text> </paragraph> <paragraph num="(3)"> <text>Assignment of Support Rights. The institutionalized spouse may not be ineligible by reason of resources determined under §D(2) of this regulation when:</text> <paragraph num="(a)"> <text>The resources are unavailable to the institutionalized spouse;</text> </paragraph> <paragraph num="(b)"> <text>Payments are not being made for the care of the institutionalized spouse;</text> </paragraph> <paragraph num="(c)"> <text>The institutionalized spouse, or that person's guardian or attorney in fact or representative, agrees to cooperate with the State in bringing a criminal action for nonsupport under Family Law Article, §§10-201 and 10-202, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>The institutionalized spouse, if capable of executing an assignment, has assigned all support rights from the community spouse to the State.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Resources may not be considered to be unavailable to the institutionalized spouse under §D3(a) of this regulation if the institutionalized spouse, or:</text> <paragraph num="(a)"> <text>That spouse's guardian or attorney in fact has the legal authority to withdraw, liquidate, or otherwise access those resources; or</text> </paragraph> <paragraph num="(b)"> <text>The institutionalized spouse's guardian or attorney in fact, has assisted in making those resources unavailable unless it can be demonstrated, to the Department's satisfaction, that the:</text> <paragraph num="(i)"> <text>Action was primarily for a purpose unrelated to Medical Assistance eligibility, and</text> </paragraph> <paragraph num="(ii)"> <text>Denial of eligibility would work an undue hardship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Resources shall be considered to be unavailable to the institutionalized spouse under §D(3)(a) of this regulation only if the community spouse has willfully failed to, and refuses to, pay for care of the institutionalized spouse or cannot be located.</text> </paragraph> <paragraph num="(6)"> <text>Section D(3)(c) or (d) of this regulation may not be considered to be satisfied if the institutionalized spouse, or the institutionalized spouse's guardian or attorney in fact, has taken any action or otherwise assisted in limiting his or her support rights from the community spouse.</text> </paragraph> <paragraph num="(7)"> <text>The Department shall waive the requirements of §D(3)(c) or (d) of this regulation if the Department determines that denial of eligibility would work an undue hardship.</text> </paragraph> <paragraph num="(8)"> <text>Separate Treatment of Resources After Eligibility for Benefits Established. During the continuous period in which an institutionalized spouse is in an institution and after the month in which an institutionalized spouse is determined to be eligible for benefits under this chapter, resources of the community spouse may not be deemed available to the institutionalized spouse.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Permitting Transfer of Resources to the Community Spouse.</text> <paragraph num="(1)"> <text>In General. An institutionalized spouse may, without regard to Regulation .08K of this chapter, transfer to the community spouse, or to another for the sole benefit of the community spouse, an amount equal to the community spouse resource allowance as defined under §E(2) of this regulation, but only to the extent the resources of the institutionalized spouse are transferred to, or for the sole benefit of, the community spouse. The transfer shall be made as soon as practicable after the date of the initial determination of eligibility, taking into account such time as may be necessary to obtain a court order under §E(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Community Spouse Resource Allowance Defined. The community spouse resource allowance is the amount by which the greatest of the following amounts exceeds the amount of resources otherwise available to the community spouse:</text> <paragraph num="(a)"> <text>$12,000, subject to adjustment under §G of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The lesser of the spousal share computed under §D(1)(ii) of this regulation or $60,000, subject to adjustment under §G of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>The amount established under §F(4) of this regulation; or</text> </paragraph> <paragraph num="(d)"> <text>The amount transferred under a court order under §E(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Transfers Under Court Orders. If a court has entered an order against an institutionalized spouse for the support of the community spouse, Regulation .08K of this chapter may not apply to amounts of resources transferred under the order for the support of the spouse or a family member as defined under §B(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Fair Hearing.</text> <paragraph num="(1)"> <text>The spouse is entitled to a fair hearing as provided for under Regulation .14 of this chapter if either the institutionalized spouse or the community spouse is dissatisfied with the determination of any of the following:</text> <paragraph num="(a)"> <text>Minimum monthly maintenance needs allowance as established under §C(5) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Determination of the amount of monthly income otherwise available to the community spouse;</text> </paragraph> <paragraph num="(c)"> <text>Computation of the spousal share of resources under §D(1) of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Attribution of resources under §D(2) of this regulation; or</text> </paragraph> <paragraph num="(e)"> <text>Determination of the community spouse resource allowance as defined under §E(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any hearing respecting the determination of the community spouse resource allowance shall be held within 30 days of the date of the request for the hearing if an application for benefits under this chapter has been made on behalf of the institutionalized spouse.</text> </paragraph> <paragraph num="(3)"> <text>Revision of Minimum Monthly Maintenance Needs Allowance. If either the institutionalized spouse or the community spouse establishes that the community spouse needs income above the level provided by the minimum monthly maintenance needs allowance due to exceptional circumstances resulting in significant financial duress, the Department shall substitute, for the minimum monthly maintenance needs allowance established under §C(5) of this regulation, an amount adequate to provide the additional income as is necessary.</text> </paragraph> <paragraph num="(4)"> <text>Revision of Community Spouse Resource Amount. If either the institutionalized spouse or the community spouse establishes that the community spouse resource amount, in relation to the amount of income generated by that amount, is inadequate to raise the community spouse's income, which shall include the amount of the community spouse monthly income allowance, to the minimum monthly maintenance needs allowance, the Department shall substitute, for the community spouse resource amount, an amount adequate to provide a minimum monthly maintenance needs allowance.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For services furnished during a calendar year after 1989, the dollar amounts specified under §§C(7) and E(2)(a) and (b) of this regulation shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers between September, 1988 and the September preceding the calendar year involved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10-2" heading="Substantial Home Equity and Exclusion of Long-Term Care Coverage."> <paragraph num="A."> <text>Subject to §E of this regulation, an institutionalized individual is not covered by Medical Assistance for long-term care services in a nursing facility, medical institution with a level of care equivalent to a nursing facility, or home and community-based services waiver if:</text> <paragraph num="(1)"> <text>The individual’s equity interest in the individual’s home property, reduced by any bona fide, legally binding, documented encumbrances secured by the home, exceeds the amount specified in §D of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>The individual does not have, lawfully residing in the home, the individual’s spouse or the individual’s son or daughter who is:</text> <paragraph num="(a)"> <text>Younger than 21 years old; or</text> </paragraph> <paragraph num="(b)"> <text>Blind or disabled as determined under Regulation .05-4 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For all applications received on January 1, 2007 or after, the Department shall evaluate the institutionalized individual’s equity interest in the individual’s home property if the individual is determined eligible for Medical Assistance based on:</text> <paragraph num="(1)"> <text>An initial determination of nursing facility or waiver eligibility;</text> </paragraph> <paragraph num="(2)"> <text>A reapplication for nursing facility or waiver eligibility after a break in nursing facility or waiver eligibility; or</text> </paragraph> <paragraph num="(3)"> <text>A redetermination after an initial determination or reapplication in accordance with §B(1) or (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The institutionalized individual’s equity interest in the individual’s home property shall be evaluated by the Department, in accordance with §§A and B of this regulation, at:</text> <paragraph num="(1)"> <text>The determination of nursing facility or waiver eligibility; and</text> </paragraph> <paragraph num="(2)"> <text>Each subsequent redetermination of nursing facility or waiver eligibility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The maximum allowable equity interest specified at §A(1) of this regulation shall be $543,000 in calendar year 2014, adjusted annually as set forth in section 6014 of the Deficit Reduction Act of 2005, Pub. L. 109-171 (DRA) by the percentage increase in the consumer price index for all urban consumers, rounded to the nearest $1,000.</text> </paragraph> <paragraph num="E."> <text>Reductions to Equity Interest.</text> <paragraph num="(1)"> <text>If the individual has ownership interest in no property other than the home, the benefit payment amount shall be applied to reduce an equal amount of home equity.</text> </paragraph> <paragraph num="(2)"> <text>A mortgage, reverse mortgage, home equity loan, lien, or other bona fide encumbrance received by the individual and secured by the home property may be considered by the Department to reduce the individual’s equity interest in the home.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An exclusion of long-term care coverage, in accordance with §A of this regulation, shall be applied even if there is a legal impediment to transferring or selling the home property.</text> </paragraph> <paragraph num="G."> <text>The Department may waive the application of §F of this regulation if the Department determines that denial of eligibility for long-term care coverage would work an undue hardship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Certification Periods."> <paragraph num="A."> <text>This regulation specifies the time periods for certifying eligible members of an assistance unit. Certification periods for retroactive and current coverage will be based on consideration periods established in accordance with the provisions of Regulations .09 and .10 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Certification of Eligible Noninstitutionalized Persons.</text> <paragraph num="(1)"> <text>The following eligible noninstitutionalized persons shall be certified for a one-time-only period of 6 months or less and scheduled redetermination for continued eligibility may not be made:</text> <paragraph num="(a)"> <text>Those who are certified for a retroactive period only, including retroactive spend-down;</text> </paragraph> <paragraph num="(b)"> <text>Those who are certified under the spend-down provision; and</text> </paragraph> <paragraph num="(c)"> <text>Those whose anticipated circumstances preclude eligibility beyond the current period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Section B(1)(c) of this regulation is limited to:</text> <paragraph num="(a)"> <text>A person who dies before the completion of the eligibility determination;</text> </paragraph> <paragraph num="(b)"> <text>A migrant worker whose date of departure or expected date of departure from the State is known; and</text> </paragraph> <paragraph num="(c)"> <text>A coverable inmate of a public institution who leaves the institution solely for admission to a medical facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Eligible persons not certified under §B(1) of this regulation shall be certified for a one-time-only period of 6 months and scheduled redetermination of eligibility shall be made.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Date for Certification to Begin and End for Noninstitutionalized Persons.</text> <paragraph num="(1)"> <text>Persons Eligible for Retroactive Coverage Under Spend-Down.</text> <paragraph num="(a)"> <text>Certification begins on the day in the period under consideration on which retroactive spend-down eligibility was met.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the most recent month in the retroactive period in which coverable expenses were incurred.</text> </paragraph> <paragraph num="(c)"> <text>Only persons who have coverable medical expenses during the period under consideration shall be certified.</text> </paragraph> <paragraph num="(d)"> <text>Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Persons Eligible for Retroactive Coverage Without Spend-Down.</text> <paragraph num="(a)"> <text>Certification begins on the first day of the earliest month of the retroactive period under consideration in which coverable medical expenses were incurred.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the most recent month in the retroactive period in which coverable medical expenses were incurred.</text> </paragraph> <paragraph num="(c)"> <text>Only persons who have coverable medical expenses during the period under consideration shall be certified.</text> </paragraph> <paragraph num="(d)"> <text>Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Persons Eligible for Current Coverage Under Spend-Down.</text> <paragraph num="(a)"> <text>Certification begins on the day in the period under consideration on which medical expenses for services already received equal or exceed the amount of excess income. The beginning date of the certification period shall be established to exclude from coverage any full day after the application date and before the certification date for which all expenses for medical services were used to establish spend-down eligibility.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the period under consideration.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Individuals Eligible for the Maryland Medicaid Managed Care Program.</text> <paragraph num="(a)"> <text>Initial certification shall be a period of 6 months.</text> </paragraph> <paragraph num="(b)"> <text>Section C(4)(a) of this regulation applies only if the individual:</text> <paragraph num="(i)"> <text>Has not been eligible for Medical Assistance any time during the calendar month immediately before the month of application; and</text> </paragraph> <paragraph num="(ii)"> <text>Has no private health insurance.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An individual certified under §C(4)(a) of this regulation is not subject to the unscheduled redetermination requirements of Regulation .12C(2) of this chapter.</text> </paragraph> <paragraph num="(d)"> <text>Subsequent certification periods shall be consistent with the provisions of this subsection.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>All Other Persons.</text> <paragraph num="(a)"> <text>Certification begins on the first day of the month of application.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the period under consideration.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death.</text> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of an eligible new member of the assistance unit pursuant to Regulation .06D of this chapter may not precede the date he becomes a member of the household.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Date for Certification to Begin and End for Eligible Institutionalized Persons.</text> <paragraph num="(1)"> <text>Persons Eligible for Retroactive Coverage Under Regulation .10C(5) of this chapter.</text> <paragraph num="(a)"> <text>Certification begins on the first day of the period under consideration.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the period under consideration.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Persons Eligible for Retroactive Coverage Under Regulation .10C(7) of this chapter.</text> <paragraph num="(a)"> <text>Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income.</text> </paragraph> <paragraph num="(b)"> <text>Certification ends on the last day of the period under consideration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Persons Eligible for Current Coverage Under Regulation .10D(3) of this chapter.</text> <paragraph num="(a)"> <text>Certification begins on the first day of the period under consideration or, at the option of the person or the person's representative, on the first day of the following month if coverage is not needed in the month of application.</text> </paragraph> <paragraph num="(b)"> <text>Certification continues until the person is determined ineligible and scheduled redetermination of eligibility shall be made at least once every 12 months.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Persons Eligible for Current Coverage Under Regulation .10D(5) of this Chapter.</text> <paragraph num="(a)"> <text>Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income.</text> </paragraph> <paragraph num="(b)"> <text>Eligibility ends on the last day of the period under consideration or, if it is known that eligibility should terminate before the end of the period under consideration, on the appropriate earlier date, and scheduled redetermination of eligibility may not be made.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Post-Eligibility Requirements."> <paragraph num="A."> <text>Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following:</text> <paragraph num="(1)"> <text>For eligible individuals in MAGI coverage groups:</text> <paragraph num="(a)"> <text>The basis and effective date for eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Instructions for reporting changes that may affect the recipients eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For eligible individuals in MAGI Exempt coverage groups:</text> <paragraph num="(a)"> <text>A finding of eligibility, the beginning and ending dates for coverage; and</text> </paragraph> <paragraph num="(b)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For ineligible individuals in MAGI coverage groups:</text> <paragraph num="(a)"> <text>A finding of ineligibility, the reason for the finding, and the regulation supporting the finding;</text> </paragraph> <paragraph num="(b)"> <text>Information regarding application for MAGI exempt coverage groups; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For ineligible individuals in MAGI exempt coverage groups:</text> <paragraph num="(a)"> <text>A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; and</text> </paragraph> <paragraph num="(b)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Recipient Responsibility.</text> <paragraph num="(1)"> <text>A recipient or his representative shall notify the Department or its designee within 10 working days of changes that may affect eligibility.</text> </paragraph> <paragraph num="(2)"> <text>A recipient or his representative shall limit use of the Medical Assistance card to the person whose name appears on the card.</text> </paragraph> <paragraph num="(3)"> <text>Third-Party Liability.</text> <paragraph num="(a)"> <text>A recipient or his representative shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of any accident or other occurrence in which a third party might be liable.</text> </paragraph> <paragraph num="(b)"> <text>Recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information that would assist the Department or its designee in seeking reimbursement.</text> </paragraph> <paragraph num="(c)"> <text>In accident situations, recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When written notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return it to the Department or its designee.</text> </paragraph> <paragraph num="(5)"> <text>Failure to comply with the provisions of §B(1), (2), and (3) of this regulation may result in the termination of assistance.</text> </paragraph> <paragraph num="(6)"> <text>Failure to comply with the provisions of §B(1)—(4) of this regulation may result in legal action, referral to the Department or its designee for reimbursement, fraud investigation, or both, for illegal use of the Medical Assistance card.</text> </paragraph> <paragraph num="(7)"> <text>Recipients shall cooperate with the Department’s quality control and audit review process, including provision and verification of all information pertinent to eligibility determination. Failure to cooperate may result in the termination of coverage.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Redeterminations.</text> <paragraph num="(1)"> <text>Redetermination for Former SSI Recipients.</text> <paragraph num="(a)"> <text>The Department or its designee shall promptly redetermine eligibility when notice has been received from the Social Security Administration that an individual's SSI benefits have been terminated.</text> </paragraph> <paragraph num="(b)"> <text>When notice of SSI termination is received, Department or its designee shall notify the person that redetermination is required to establish continuing eligibility and shall make the application available to him.</text> </paragraph> <paragraph num="(c)"> <text>When the written or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period.</text> </paragraph> <paragraph num="(d)"> <text>The Department or its designee shall notify the individual or his representative of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process.</text> </paragraph> <paragraph num="(e)"> <text>All non-financial and financial factors for continuing eligibility shall be met.</text> </paragraph> <paragraph num="(f)"> <text>The following applies when the individual is determined ineligible for Medical Assistance:</text> <paragraph num="(i)"> <text>When the SSI termination is received by the tenth day of the month, the Department or its designee shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with COMAR 10.01.04.</text> </paragraph> <paragraph num="(ii)"> <text>When the SSI termination notice is received after the tenth day of the month, the Department or its designee shall cancel certification effective the end of the following month unless the recipient requests a hearing in accordance with COMAR 10.01.04.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>The following applies when the person is determined ineligible for Medical Assistance:</text> <paragraph num="(i)"> <text>When SSI termination is received by the tenth day of the month, the local department of social services shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with Regulation .13 of this chapter.</text> </paragraph> <paragraph num="(ii)"> <text>When the SSI termination notice is received after the tenth day of the month, the local department of social services shall cancel certification effective the end of the following month unless the recipient requests a hearing I accordance with Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Notice of Eligibility Decisions.</text> <paragraph num="(i)"> <text>Eligible Individuals. Individuals who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>Ineligible Individuals. Individuals determined ineligible shall be sent notice in accordance with §A(3) and (4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>When ineligibility is due to excess income only, the person will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unscheduled Redetermination.</text> <paragraph num="(a)"> <text>The Department or its designee shall promptly make unscheduled redetermination when:</text> <paragraph num="(i)"> <text>The person's circumstances suggest future changes which may affect eligibility before the due date of a scheduled redetermination;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant facts or changes in circumstances are reported by the recipient or someone on his behalf; or</text> </paragraph> <paragraph num="(iii)"> <text>Relevant facts or changes are brought to the attention of the Department or its designee from other responsible sources.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. Notification will be sent in a timely manner so that a decision of eligibility will be made within 30 days from the date of change.</text> </paragraph> <paragraph num="(c)"> <text>The Department or its designee shall notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process.</text> </paragraph> <paragraph num="(d)"> <text>The Department or its designee may not require the recipient or his representative to appear in unless the Department or its designee has determined that a face-to-face contact is necessary to make an accurate eligibility determination, or the recipient requests a face to face interview.</text> </paragraph> <paragraph num="(e)"> <text>All non-financial and financial factors for continuing eligibility shall be met.</text> </paragraph> <paragraph num="(f)"> <text>Eligibility Decisions.</text> <paragraph num="(i)"> <text>Eligibility Continued for the Remainder of the Certification Period. Recipients who are determined eligible for the remainder of the certification period will be sent notice in accordance with §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>Recipients Determined Ineligible for the Remainder of the Certification Period. Recipients determined ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(3) and (4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A person may reapply at any time after the cancellation of current eligibility and a new period under consideration will be established.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Scheduled Redetermination.</text> <paragraph num="(a)"> <text>The Department or its designee shall make scheduled redeterminations at least once every 6 months for noninstitutionalized individuals certified under Regulation .11B(3) of this chapter and at least once every 12 months for institutionalized individuals certified under Regulation .11D(3) of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. The notice and application will be sent at least 45 days before expiration of the current certification period.</text> </paragraph> <paragraph num="(c)"> <text>When the written, telephonic, or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period.</text> </paragraph> <paragraph num="(d)"> <text>A recipient shall be treated the same as an applicant at the time of scheduled redetermination.</text> </paragraph> <paragraph num="(e)"> <text>All nonfinancial and financial factors of eligibility shall be met.</text> </paragraph> <paragraph num="(f)"> <text>The local Department or its designee shall make timely decisions in accordance with the provisions of Regulation .04H of this chapter.</text> </paragraph> <paragraph num="(g)"> <text>Eligibility Decisions.</text> <paragraph num="(i)"> <text>Eligibility Established. Applicants who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>Ineligibility Established. Applicants determined ineligible for the new period under consideration shall be sent notice in accordance with §A(3) and (4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>When ineligibility is due to excess income only, the applicant will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Subsequent Application. A person may reapply when eligibility is not met during the periods established in §C(1) and (3) of this regulation.</text> </paragraph> <paragraph num="E."> <text>Continuous Eligibility for Children.</text> <paragraph num="(1)"> <text>The Department shall establish continuous eligibility periods for individuals who are:</text> <paragraph num="(a)"> <text>Younger than 19 years old; and</text> </paragraph> <paragraph num="(b)"> <text>Eligible and enrolled for mandatory or optional coverage.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individuals who are in a period of continuous eligibility shall, with the exception of the circumstances in §E(4) of this regulation, maintain coverage despite any change in circumstance that would otherwise preclude eligibility.</text> </paragraph> <paragraph num="(3)"> <text>The period of continuous eligibility shall:</text> <paragraph num="(a)"> <text>Begin on the first day of the month in which initial eligibility was determined or a renewal of eligibility is approved as a result of redetermination; and</text> </paragraph> <paragraph num="(b)"> <text>Remain in effect for a 12-month period or for individuals covered under COMAR 10.09.62, until birth.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual’s eligibility may be redetermined during their continuous eligibility period if one or more of the following changes in circumstances occur:</text> <paragraph num="(a)"> <text>The individual attains the maximum age specified in §E(1)(a) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The individual or the individual’s representative requests a voluntary termination of eligibility;</text> </paragraph> <paragraph num="(c)"> <text>The individual ceases to meet the residency requirements established in Regulation .05-3 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>The individual dies; or</text> </paragraph> <paragraph num="(e)"> <text>The Department or its designee determines that eligibility was erroneously granted at the most recent determination, redetermination, or renewal of eligibility due to one or more of the following:</text> <paragraph num="(i)"> <text>Agency error; or</text> </paragraph> <paragraph num="(ii)"> <text>Fraud, abuse, or perjury attributed to the individual or the individual’s representative.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Hearings."> <text>The procedures for the Department or its designee granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Fraud."> <paragraph num="A."> <text>“Medicaid fraud” means:</text> <paragraph num="(1)"> <text>Knowingly and willfully making or causing to be made any false statement or representation of a material fact in any application for any benefit or payment under a State plan established by Title XIX of the Social Security Act of 1939;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to those benefits or payments;</text> </paragraph> <paragraph num="(3)"> <text>Having knowledge of the occurrence of any event affecting:</text> <paragraph num="(a)"> <text>The initial or continued right to those benefits or payments, or</text> </paragraph> <paragraph num="(b)"> <text>The initial or continued right to those benefits or payments to any other individual in whose behalf an application has been made or in whose behalf benefits or payments are being received, and concealing or failing to disclose that event with an intent to secure fraudulently those benefits or payments either in a greater amount or quantity than is due or when benefits or payments are not authorized;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Having made application to receive or having received any of those benefits or payments for the use and benefit of another, and knowingly and willfully converting any part of the benefit or payment to a use other than for the use and benefit of that other person;</text> </paragraph> <paragraph num="(5)"> <text>Fraudulently obtaining, attempting to obtain, or aiding another person in obtaining or attempting to obtain any drug product or any medical care, the benefit or payment of any part of which is or may be made from federal or state funds under a state Medical Assistance program, by use of:</text> <paragraph num="(a)"> <text>Fraud, deceit, misrepresentation, or subterfuge;</text> </paragraph> <paragraph num="(b)"> <text>Forgery or alteration of a Medical Assistance prescription; or</text> </paragraph> <paragraph num="(c)"> <text>Concealment of any material fact or by the use of false names or addresses;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Possession of a blank Medical Assistance prescription, unless possession is authorized by:</text> <paragraph num="(a)"> <text>A contract or other power, right, or permission to manufacture, store, transport, or distribute blank prescriptions;</text> </paragraph> <paragraph num="(b)"> <text>A grant of a rendering privilege as evidenced by the issuance of a rendering number by a state Medical Assistance program by which one is authorized to prescribe pharmaceutical products for Medical Assistance recipients if the authorization:</text> <paragraph num="(i)"> <text>To possess a blank Medical Assistance prescription terminates 30 days after notice of suspension or termination of provider status in a state Medical Assistance program or exhaustion of final appeal rights, whichever is later; and</text> </paragraph> <paragraph num="(ii)"> <text>Does not extend to possession of blank Medical Assistance prescriptions which have been obtained from a source not authorized to distribute blank Medical Assistance prescriptions under §S(6)(a) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Possession of a Medical Assistance card without the authorization of the individual to whom the card is issued, unless:</text> <paragraph num="(a)"> <text>Possession is obtained by a provider without knowledge that the presenting party lacked authorization; or</text> </paragraph> <paragraph num="(b)"> <text>Possession is pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Manufacture, distribution, or possession of a counterfeit Medical Assistance card, or prescription blank except when possession is obtained:</text> <paragraph num="(a)"> <text>By a provider without knowledge that the card or prescription blank is counterfeit; or</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Manufacture, distribution, or possession of a provider identification plate used or capable of use to imprint Medical Assistance prescriptions unless authorized by:</text> <paragraph num="(a)"> <text>A contract or other power, right, or permission to manufacture, transport, distribute, handle, or possess the plates;</text> </paragraph> <paragraph num="(b)"> <text>Issuance by a state Medical Assistance program to the party in possession; or</text> </paragraph> <paragraph num="(c)"> <text>Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Examples. The following are examples of circumstances that may be Medicaid fraud:</text> <paragraph num="(1)"> <text>Failure to report income, resources, if applicable, and family composition at the time of application or reapplication;</text> </paragraph> <paragraph num="(2)"> <text>Failure to report within 10 working days any changes in income, resources, if applicable, and circumstances during any period of eligibility;</text> </paragraph> <paragraph num="(3)"> <text>Lending a Medical Assistance card to another person;</text> </paragraph> <paragraph num="(4)"> <text>Using or attempting to use a Medical Assistance card with intent to secure fraudulently benefits which are not authorized.</text> </paragraph> </paragraph> <paragraph num="C."> <text>LDSS Reporting. All cases of suspected Medicaid fraud that are discovered by personnel of a local department of social services shall be reported to the Department or its designee.</text> </paragraph> <paragraph num="D."> <text>Other Reporting. All cases of suspected Medicaid fraud that are discovered by agencies other than a local department of social services, that is, other state or federal agencies, providers, or concerned citizens, may be reported to the Department or its designee.</text> </paragraph> <paragraph num="E."> <text>Review and Investigation. The Department or its designee shall review and, when appropriate, investigate all referrals when an allegation is made that a misrepresentation of a material fact has been made or is suspected to have been made.</text> </paragraph> <paragraph num="F."> <text>Disposition of Referrals. Each referral shall be processed by the Department or its designee for appropriate resolution which includes, but is not limited to:</text> <paragraph num="(1)"> <text>Referral for prosecution;</text> </paragraph> <paragraph num="(2)"> <text>Filing of charges at District Court;</text> </paragraph> <paragraph num="(3)"> <text>Recovery of incorrect benefit payments;</text> </paragraph> <paragraph num="(4)"> <text>A finding that the allegation has not been sustained;</text> </paragraph> <paragraph num="(5)"> <text>Referral to the appropriate agency; and</text> </paragraph> <paragraph num="(6)"> <text>Other administrative action.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Penalties. A person convicted of the crime of Medicaid fraud is subject to penalties as described in Criminal Law Article, §§8-510—8-512, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14-1" heading="Recipient Abuse."> <paragraph num="A."> <text>Forms of Abuse. Recipient abuse exists when:</text> <paragraph num="(1)"> <text>A recipient utilizes an inappropriate type of provider for care;</text> </paragraph> <paragraph num="(2)"> <text>A recipient utilizes an appropriate type of provider at an inappropriate frequency for care;</text> </paragraph> <paragraph num="(3)"> <text>A recipient utilizes an appropriate provider in an inappropriate manner; or</text> </paragraph> <paragraph num="(4)"> <text>A recipient utilizes a Medical Assistance card in an inappropriate manner.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Examples. The following are examples of circumstances that may be recipient abuse:</text> <paragraph num="(1)"> <text>Misrepresenting to a provider material facts regarding symptoms, circumstances, or treatment by other providers;</text> </paragraph> <paragraph num="(2)"> <text>Failing to affirmatively disclose to a provider any treatment or services being provided by another provider;</text> </paragraph> <paragraph num="(3)"> <text>Losing or failing to maintain security sufficient to prevent loss or theft of more than one Medical Assistance card during a certification period;</text> </paragraph> <paragraph num="(4)"> <text>Utilizing an emergency room of a hospital or a specialty outpatient clinic of a hospital as a primary care provider when primary care providers are available in the service area in which the recipient resides;</text> </paragraph> <paragraph num="(5)"> <text>Underutilizing the appropriate providers for the proper care and management of an existing health condition;</text> </paragraph> <paragraph num="(6)"> <text>Obtaining medications that require close physician monitoring while not appropriately using the physician services which could provide the monitoring;</text> </paragraph> <paragraph num="(7)"> <text>Using or maintaining custody or possession of a Medical Assistance card in such a manner that it is used for an unauthorized or illegal purpose.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures.</text> <paragraph num="(1)"> <text>The Department or its designee, shall determine whether recipient abuse exists using the procedures in §C(2)—(8) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Cases may be reviewed on the basis of statistical reports, outside complaints, referrals from other agencies, or other appropriate sources.</text> </paragraph> <paragraph num="(3)"> <text>A preliminary review shall be conducted to determine whether the recipient's alleged or noted behavior is of the form specified under §A(1)—(3) of this regulation or is of the form specified under §A(4) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>If the alleged or noted behavior is one of the types listed in §A(1)—(3) of this regulation, all relevant and available information shall be forwarded for medical review as specified under §B(5) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>If the alleged or likely behavior is of the type listed in §A(4) of this regulation, all relevant and available information shall be forwarded for administrative review as specified under §C(7) of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>When a case is referred for medical review, a medical professional employed by the Department or its designee shall determine whether the recipient's use of medical services constitutes abuse, as defined under §A(1), (2), or (3) of this regulation. The medical reviewer shall consider all relevant and available information including Medical Assistance payment records and information secured from interviews, if conducted, in making a decision. The reviewer may, when appropriate, obtain records from other sources, including providers of medical services.</text> </paragraph> <paragraph num="(7)"> <text>When a case is referred for administrative review, a determination shall be made by the Department or its designee, regarding whether the recipient's use of benefits constitutes abuse as defined under §A(4) of this regulation.</text> </paragraph> <paragraph num="(8)"> <text>If a recipient has been convicted of a crime involving use of Medical Assistance benefits, as defined in §A of this regulation, the Department or its designee may consider the recipient to have committed abuse as described under §A(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Notice. A recipient determined to have abused the Medical Assistance entitlement shall receive notice to that effect. Notice includes the following:</text> <paragraph num="(1)"> <text>A statement of the reason or reasons why the recipient was found to have abused the Medical Assistance entitlement;</text> </paragraph> <paragraph num="(2)"> <text>If applicable, a statement that the recipient will be enrolled in the Corrective Managed Care Program and the effective date and duration of that enrollment;</text> </paragraph> <paragraph num="(3)"> <text>A statement regarding an opportunity to provide additional information which will be considered before enrollment becomes effective;</text> </paragraph> <paragraph num="(4)"> <text>If applicable, a statement regarding an opportunity to identify a preference for an assigned primary medical care provider or pharmacy; and</text> </paragraph> <paragraph num="(5)"> <text>A statement of appeal rights under Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Consideration of Recipient Information.</text> <paragraph num="(1)"> <text>Additional information received from the recipient under §D(3) of this regulation is considered relative to the appropriateness of the recipient's enrollment in the Corrective Managed Care Program.</text> </paragraph> <paragraph num="(2)"> <text>Notice of the determination of the Department or its designee regarding the additional information shall be sent to the recipient. The notice shall either confirm or reverse the decision to enroll the recipient.</text> </paragraph> <paragraph num="(3)"> <text>Information received from the recipient under §D(4) of this regulation is considered relative to the designation of a primary medical provider or pharmacy in accordance with §G(7) of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Corrective Managed Care Program.</text> <paragraph num="(1)"> <text>A recipient determined to have abused the Medical Assistance entitlement shall be enrolled in the Corrective Managed Care Program in which the recipient shall be required to meet the requirements of §F(1)—(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The recipient shall obtain all covered physician, hospital outpatient and inpatient, and clinic services, except methadone clinic and all other drug and alcohol abuse services and emergency services, from, or upon written referral by, a single primary medical provider.</text> </paragraph> <paragraph num="(3)"> <text>The recipient shall obtain prescribed drugs only from a single designated pharmacy provider, except in an emergency or pursuant to hospital inpatient treatment.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provider Selection.</text> <paragraph num="(1)"> <text>The Department or its designee shall select primary medical and pharmacy providers for the recipient according to the requirements of §G(2)—(7) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The primary medical provider may be any physician who participates in the Medical Assistance Program and whose practice is chiefly in one of the following specialties which include general practice, family practice, pediatrics, obstetrics-gynecology, or internal medicine.</text> </paragraph> <paragraph num="(3)"> <text>The Department or its designee may also designate a physician group, community health center, or clinic which participates in the Program as a physician provider and which assigns practitioners in one or more of the specialties named under §G(2) of this regulation to be the designated primary medical provider for the recipient.</text> </paragraph> <paragraph num="(4)"> <text>The Department or its designee may designate a provider which delivers limited or specialty services if the designation is in the recipient's best interest and the provider agrees to deliver or manage the recipient's primary care and refer the recipient for other services as necessary.</text> </paragraph> <paragraph num="(5)"> <text>The pharmacy provider may be any pharmacy, or any single branch of a pharmacy chain, which participates in the Medical Assistance Program.</text> </paragraph> <paragraph num="(6)"> <text>The recipient shall be afforded an opportunity to suggest primary medical and pharmacy providers. However, the Department or its designee is not bound by the recipient's suggestion and may designate other providers if, in its sole discretion, the recipient's choice of provider would not serve the recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Program may designate a new primary medical or pharmacy provider if the:</text> <paragraph num="(1)"> <text>Recipient moves out of the service area of the provider;</text> </paragraph> <paragraph num="(2)"> <text>Provider originally selected refuses to serve as the recipient's provider;</text> </paragraph> <paragraph num="(3)"> <text>Program determines that the provider is not reasonably accessible to the recipient or does not meet accepted standards of medical or pharmacy practice;</text> </paragraph> <paragraph num="(4)"> <text>Recipient has not responded affirmatively to the imposition of restrictions; or</text> </paragraph> <paragraph num="(5)"> <text>Recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits would, in the Program's sole discretion, be better served by an alternative designation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Time of Period of Enrollment for the Corrective Managed Care Program.</text> <paragraph num="(1)"> <text>The period of enrollment is 24 months.</text> </paragraph> <paragraph num="(2)"> <text>A recipient who has completed the period of enrollment and who is subsequently found, through the procedures specified under §C of this regulation, to have resumed abusive practices, shall be enrolled for an additional period of 36 months.</text> </paragraph> <paragraph num="(3)"> <text>A recipient found to have abused Medical Assistance benefits while enrolled in the Corrective Managed Care Program shall have the enrollment period extended for 24 months.</text> </paragraph> <paragraph num="(4)"> <text>A recipient who has been found on three separate determinations under §C(5)—(7) of this regulation to have abused Medical Assistance benefits shall be enrolled for a period of 60 months.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If an enrolled recipient loses and regains eligibility for Medical Assistance benefits, the recipient shall be re-enrolled at the resumption of eligibility for a full enrollment period.</text> </paragraph> <paragraph num="K."> <text>The final determination of abuse, the decision to enroll the recipient for the Corrective Managed Care Program, and the designation of primary medical and pharmacy providers shall be the responsibility of the Department or its designee.</text> </paragraph> <paragraph num="L."> <text>The recipient shall be given notice of an opportunity for a hearing in conformity with COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Liens, Adjustments, and Recoveries."> <paragraph num="A."> <text>Definitions. In this regulation, the following terms have the meanings indicated:</text> <paragraph num="(1)"> <text>“Dependent” means a:</text> <paragraph num="(a)"> <text>Child of the decedent, or the decedent's descendants;</text> </paragraph> <paragraph num="(b)"> <text>Sibling, including half or step, of the decedent; or</text> </paragraph> <paragraph num="(c)"> <text>Parent of the decedent, or the decedent's ancestors.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Discharge from a long-term care facility and return home” means the release of a person from that facility for the purpose of returning to the home for permanent residence.</text> </paragraph> <paragraph num="(3)"> <text>“Equity interest in the home” means co-ownership of the home which is not the result of a transfer of the property for less than the fair market value within 2 years before institutionalization.</text> </paragraph> <paragraph num="(4)"> <text>“Estate” means all real and personal property and other assets included within an individual's estate, as defined for purposes of State probate law.</text> </paragraph> <paragraph num="(5)"> <text>“Group health plan” means any plan, including a self-insured plan, of or contributed to by an employer to provide health care, directly or otherwise, to the employer's employees, former employees, or their families.</text> </paragraph> <paragraph num="(6)"> <text>“Incorrect payment of benefits” means payment of benefits to which a recipient is not entitled.</text> </paragraph> <paragraph num="(7)"> <text>“Lawfully residing in the home” means residing in the home with the permission of the owner or, if under guardianship, the owner's legal guardian.</text> </paragraph> <paragraph num="(8)"> <text>“Real property” means property which is fixed or immovable, such as land or a building.</text> </paragraph> <paragraph num="(9)"> <text>“Residing in the home on a continuous basis” means using the home as the principal place of residence.</text> </paragraph> <paragraph num="(10)"> <text>“Substantial hardship” means the Department's estate claim will result in the sale or transfer of the real property owned by the decedent and that the sale or transfer will result in the removal from the property of a dependent who:</text> <paragraph num="(a)"> <text>Resided in the property on the date of the decedent's death;</text> </paragraph> <paragraph num="(b)"> <text>Has resided in the property continuously for a period beginning at least 2 years before the decedent's death; and</text> </paragraph> <paragraph num="(c)"> <text>Cannot provide an alternate residence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="A-1."> <text>The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the following circumstances:</text> <paragraph num="(1)"> <text>Under a court order;</text> </paragraph> <paragraph num="(2)"> <text>In any situation in which a recipient has a cause of action against any person for medical expenses arising from that cause of action; or</text> </paragraph> <paragraph num="(3)"> <text>As a result of payment by the Department for services for which health care coverage was available to a recipient.</text> </paragraph> </paragraph> <paragraph num="A-2."> <text>Liens.</text> <paragraph num="(1)"> <text>Incorrect Payments. Following a court judgment which has determined that benefits were incorrectly paid for a person, the Department shall impose a lien against the person's property, both personal and real, before the person's death, on account of Medical Assistance claims paid or to be paid on the person's behalf.</text> </paragraph> <paragraph num="(2)"> <text>Correct Payments. Except as provided under §A-2(3) of this regulation, the Department shall impose a lien against the real property of a person, before the person's death, on account of Medical Assistance claims paid or to be paid on that person's behalf under the following circumstances:</text> <paragraph num="(a)"> <text>The person owns real property, is a patient in a long-term care facility, and is required, as a condition of receiving Medical Assistance services, to spend for costs of medical care all but a minimal amount of his income required for personal needs; and</text> </paragraph> <paragraph num="(b)"> <text>The Department has determined, after notice and opportunity for a hearing, that there is no reasonable expectation that the person can be discharged from the long-term care facility and return home.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Restrictions on Placing a Lien. The Department may not impose a lien on the home of an institutionalized individual under §A-2(2) of this regulation if any of the following individuals lawfully reside in the home. The institutionalized individual's:</text> <paragraph num="(a)"> <text>Spouse;</text> </paragraph> <paragraph num="(b)"> <text>Child as defined in Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; or</text> </paragraph> <paragraph num="(d)"> <text>Sibling, who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date of the institutionalized person's admission to a long-term care facility.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Termination of a Lien. Any lien imposed on a person's real property under §A-2(2) of this regulation will dissolve if the person is discharged from a long-term care facility and returns to the home.</text> </paragraph> <paragraph num="(5)"> <text>Delay in the Imposition of a Lien.</text> <paragraph num="(a)"> <text>When the imposition of a lien against a person's property is delayed because of the person's mental incompetence, eligibility may be granted pending the appointment of a legal representative for the person.</text> </paragraph> <paragraph num="(b)"> <text>The effective date of the lien shall be the date eligibility was granted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="A-3."> <text>Adjustments and Recoveries.</text> <paragraph num="(1)"> <text>The Department shall seek recovery of Medical Assistance benefits correctly paid:</text> <paragraph num="(a)"> <text>From the estate of any individual who was 55 years old or older when the individual received Medical Assistance benefits; and</text> </paragraph> <paragraph num="(b)"> <text>From the estate or upon sale of the property on which a lien was imposed and which was owned by an individual described under §A-2(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall seek recovery under §A-3(1) of this regulation of Medical Assistance benefits correctly paid only:</text> <paragraph num="(a)"> <text>After the death of the person's surviving spouse;</text> </paragraph> <paragraph num="(b)"> <text>When the individual has no surviving child as defined in Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>When the person has no surviving son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>In the case of liens imposed on a person's home under §A-2(2) of this regulation, when there is no:</text> <paragraph num="(i)"> <text>Sibling of the person lawfully residing in the home, who has resided there for a period of at least 1 year immediately before the date of the person's admission to a long-term care facility and who has lawfully resided there on a continuous basis since that time, or</text> </paragraph> <paragraph num="(ii)"> <text>Son or daughter of the person lawfully residing in the home, who has resided there for a period of at least 2 years immediately before the date of the person's admission to a long-term care facility, who has lawfully resided there on a continuous basis since that time, and who can establish to the Department's satisfaction that he or she provided the care that permitted the person to reside in the home rather than in the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department may not seek recovery from the estate of a deceased individual under §A-3(1) and (2) of this regulation if, in the Department's judgment, substantial hardship exists.</text> </paragraph> <paragraph num="(4)"> <text>The Department may not seek recovery from the estate of a deceased individual for Medical Assistance payments of Medicare premiums, copayments, or deductibles.</text> </paragraph> <paragraph num="(5)"> <text>The Department may not seek recovery from the estate of a deceased individual to the extent of the value of LTC partnership policy benefits furnished to the individual up to the time of death.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall accept reimbursement when voluntarily offered by a current or former recipient or someone acting on his behalf.</text> </paragraph> <paragraph num="C."> <text>Repealed.</text> </paragraph> <paragraph num="D."> <text>Extended Benefits Pending a Hearing Decision.</text> <paragraph num="(1)"> <text>The Department or its designee shall consider reimbursement in all cases in which:</text> <paragraph num="(a)"> <text>A recipient received extended benefits pending a hearing and decision by an administrative law judge at the Office of Administration Hearings; and</text> </paragraph> <paragraph num="(b)"> <text>The administrative law judge affirmed the original decision of the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department or its designee shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §D(1) of this regulation. This provision may not apply to a individual who requested a hearing and extended benefits resulting from a bona fide belief that the Department or its designee has taken an adverse action erroneously.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or person acting responsibly for the recipient.</text> </paragraph> <paragraph num="F."> <text>Assignment of Benefits, Release of Information, and Requirement of Cooperation by Recipient in Recovery Procedures.</text> <paragraph num="(1)"> <text>A recipient of Medical Assistance is deemed to have created an authorization for the release to the Department of all data, records, and information by insurance companies, nonprofit health service plans, providers of medical care, employers, unions, governmental agencies, and any other agencies, organizations, or individuals necessary for the Department's pursuit of third-party reimbursement. The authorization extends to all information relevant to third-party reimbursement or third-party health care coverage.</text> </paragraph> <paragraph num="(2)"> <text>The local department of social services shall take reasonable measures to identify and report to the Department on a form designated by the Department all possible third-party benefits available to persons determined eligible for Medical Assistance.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall collect available benefits from third parties determined liable to pay for services received under Medical Assistance.</text> </paragraph> <paragraph num="(4)"> <text>An individual who receives medical services that was or will be paid for by Medical Assistance is deemed to have made assignment to the Department of:</text> <paragraph num="(a)"> <text>His own rights to any medical care support available under an order of a court or an administrative agency, and any third-party payments for medical care; and</text> </paragraph> <paragraph num="(b)"> <text>The rights of any other individual eligible under the plan, for whom he can legally make an assignment.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Assignment of rights to benefits does not include assignment of rights to Medicare benefits.</text> </paragraph> <paragraph num="(6)"> <text>An applicant or recipient of Medical Assistance shall cooperate in:</text> <paragraph num="(a)"> <text>Establishing paternity for a child born out of wedlock for whom he can legally assign rights; and</text> </paragraph> <paragraph num="(b)"> <text>Obtaining medical care support and payments for himself and any other individual for whom he can legally assign rights.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Waiver.</text> <paragraph num="(a)"> <text>The Department shall waive the requirements in §G(6) of this regulation if the Department, through the local department of social services, determines that the individual has good cause for refusing to cooperate.</text> </paragraph> <paragraph num="(b)"> <text>With respect to establishing support paternity of a child born out of wedlock or obtaining medical care and payments for a child for whom the individual can legally assign rights, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child if it is reasonably anticipated that cooperation will result in:</text> <paragraph num="(i)"> <text>Physical harm to the child for whom support is to be sought;</text> </paragraph> <paragraph num="(ii)"> <text>Emotional harm to the child for whom support is to be sought;</text> </paragraph> <paragraph num="(iii)"> <text>Physical harm to the parent or caretaker relative with whom the child is living which reduces the person's capacity to care for the child adequately; or</text> </paragraph> <paragraph num="(iv)"> <text>Emotional harm to the parent or caretaker relative with whom the child is living, of such nature or degree that it reduces the person's capacity to care for the child adequately.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If at least one of the following circumstances exists, and the Department, through the local department of social services, believes that because of the existence of that circumstance, in the particular case, proceeding to establish paternity or secure support would be detrimental to the child for whom support would be sought, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child:</text> <paragraph num="(i)"> <text>The child for whom support is sought was conceived as a result of incest or forcible rape;</text> </paragraph> <paragraph num="(ii)"> <text>Legal proceedings for the adoption of the child are pending before a court of competent jurisdiction; or</text> </paragraph> <paragraph num="(iii)"> <text>The applicant or recipient is currently being assisted by a public or licensed private social agency to resolve the issue of whether to keep the child or relinquish him for adoption, and the discussions have not gone on for more than 3 months.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the Department of Human Services has made a finding that good cause for refusal to cooperate does or does not exist, the Department shall adopt that finding as its own for this purpose.</text> </paragraph> <paragraph num="(e)"> <text>With respect to obtaining medical care support and payments for an individual in any case not covered by §G(7)(b) or (c) of this regulation, the Department, through the local department of social services, shall find that cooperation is against the best interests of the individual or other person to whom Medical Assistance is being furnished, if it is reasonably anticipated that cooperation will result in reprisal against, and cause physical or emotional harm to, the individual or other person.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The Department or its designee shall:</text> <paragraph num="(a)"> <text>Deny or terminate eligibility for any applicant or recipient who refuses to cooperate as required under §G(6) of this regulation unless cooperation has been waived;</text> </paragraph> <paragraph num="(b)"> <text>Provide Medical Assistance to any individual who:</text> <paragraph num="(i)"> <text>Cannot legally assign his own rights, and</text> </paragraph> <paragraph num="(ii)"> <text>Would otherwise be legally eligible for Medical Assistance but for the refusal by a person legally able to assign his rights or to cooperate as required by this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>The assignment created by this regulation shall be effective as long as the recipient is eligible for Medical Assistance and remains effective for all services paid by the Program during this period of eligibility, and for those services which were erroneously provided to ineligible persons and paid for by the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Interpretive Regulation."> <text>Except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Information from and Liability of Health Insurance Carriers."> <paragraph num="A."> <text>A carrier shall:</text> <paragraph num="(1)"> <text>Provide, at the request of the Department, information about individuals who are eligible for benefits under the Program or are Program recipients so that the Department may determine:</text> <paragraph num="(a)"> <text>Whether an individual, the spouse of an individual, or the dependent of an individual is receiving health care coverage from a carrier; and</text> </paragraph> <paragraph num="(b)"> <text>The nature of that coverage;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide the information required under §A of this regulation in a manner prescribed by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Accept the Program's right of recovery and the assignment to the Program of any right of an individual or other entity to payment from the carrier for an item or service for which payment has been made under the Program if the carrier has a legal obligation to make payment for the item or service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Subject to §A of this regulation, a carrier may not reject, deny, limit, cancel, refuse to renew, increase the rates of, affect the terms or conditions of, or otherwise affect a health insurance policy or contract for a reason based wholly or partly on the:</text> <paragraph num="(1)"> <text>Eligibility of the individual for receiving benefits under the Program; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt by an individual of benefits under the Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A carrier shall comply with the provisions of Health-General Article, §15-144, Annotated Code of Maryland, pertaining to health maintenance organizations.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 1, 1983 (10:6 Md. R. 558)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, and .06 amended as an emergency provision effective December 1, 1992 (19:25 Md. R. 2198); amended permanently effective June 1, 1993 (20:10 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 1, 1986 (13:8 Md. R. 898); August 8, 1988 (15:16 Md. R. 1914); May 1, 1989 (16:8 Md. R. 910); December 1, 1992 (19:23 Md. R. 2041); March 24, 1997 (24:6 Md. R. 485); June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02B; .03C; .04; .07B, I, J, L; .08G, H; .09B; .10C, E, F; .11D, E; .12B; .14A; and .15D amended as an emergency provision effective May 1, 1983 (10:11 Md. R. 962); adopted permanently effective September 1, 1983 (10:17 Md. R. 1521)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02B and .05A amended as an emergency provision effective October 3, 1997 (24:22 Md. R. 1550); amended permanently effective January 12, 1998 (25:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 24, 2005 (32:23 Md. R. 1826); December 31, 2007 (34:26 Md. R. 2262); October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective May 4, 1990 (17:11 Md. R. 1339); amended permanently effective August 13, 1990 (17:15 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1B amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2F amended effective January 6, 2003 (29:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-3 adopted effective June 7, 2004 (31:11 Md. R. 856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-3 amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-4 adopted effective June 7, 2004 (31:11 Md. R. 856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-4A amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 1, 1986 (13:8 Md. R. 898); May 1, 1989 (16:8 Md. R. 910); June 30, 2008 (35:13 Md. R. 1179); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04J amended as an emergency provision effective October 1, 2001 (28:24 Md. R. 2125); emergency status expired March 29, 2002</annotation> <annotation type="History" subtype="Administrative History">Regulations .04J, .07B, G—N, and .08B, G—L amended as an emergency provision effective March 1, 1984 (11:5 Md. R. 449); emergency status extended at 11:14 Md. R. 1247 (July 6, 1984)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04J, .07B, G—N, and .08B, G—L amended effective October 15, 1984 (11:20 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04J amended effective September 20, 2010 (37:19 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective March 11, 1985 (12:5 Md. R. 482); April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective March 11, 1985 (12:5 Md. R. 482); March 24, 1997 (24:6 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H amended effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1B amended effective April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-2 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-2 amended effective April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-3 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-3K amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-4 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-5 adopted effective September 24, 2007 (34:20 Md. R. 1737)</annotation> <annotation type="History" subtype="Administrative History">Regulations .06, .07M, .08, .10, .11, .12C, and .15 amended effective May 1, 1986 (13:8 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, M amended effective June 30, 2008 (35:13 Md. R. 1179)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J amended effective October 8, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended as an emergency provision effective September 30, 1989 (16:21 Md. R. 2258); adopted permanently effective February 1, 1990 (17:1 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1173); amended permanently effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended effective August 10, 1987 (14:16 Md. R. 1774); July 1, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07N and .10E amended as an emergency provision effective July 1, 1985 (12:13 Md. R. 1274); adopted permanently effective November 4, 1985 (12:22 Md. R. 2104)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective December 10, 1991 (18:26 Md. R. 2827); amended permanently effective April 1, 1992 (19:5 Md. R. 577)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective November 25, 1992 (19:25 Md. R. 2199); amended permanently effective March 29, 1993 (20:4 Md. R. 371)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); amended permanently effective November 1, 1993 (20:21 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07N amended as an emergency provision effective August 10, 1994 (21:18 Md. R. 1506); amended permanently effective November 7, 1994 (21:22 Md. R. 1876)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective May 15, 1992 (19:11 Md. R. 1012); emergency status extended at 19:19 Md. R. 1702; amended permanently effective September 14, 1992 (19:18 Md. R. 1656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1179)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective September 1, 1993 (20:17 Md. R. 1346); January 12, 1987 (14:1 Md. R. 31); August 22, 1988 (15:17 Md. R. 2049); July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G, H amended effective June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G, H, and H-1 amended effective January 12, 1987 (14:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G, H, and I amended effective August 22, 1988 (15:17 Md. R. 2049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G, H, and K amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G, I amended as an emergency provision effective October 1, 2001 (29:4 Md. R. 413); emergency status extended at 29:8 Md. R. 696; amended permanently effective April 29, 2002 (29:8 Md. R. 700)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J-1 adopted effective September 1, 1993 (20:17 Md. R. 1346)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J-1 amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08L amended effective June 29, 1987 (14:13 Md. R. 1474); January 25, 1988 (15:2 Md. R. 121)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08L amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08M amended effective June 29, 1987 (14:13 Md. R. 1474)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08 and .10 amended, and new Regulation .10-1 adopted as an emergency provision effective September 30, 1989 (16:21 Md. R. 2259); adopted permanently effective February 1, 1990 (17:1 Md. R. 69) (Regulation .10-1 originally adopted as Regulation .11)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08-1 and .08-2 adopted effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-2 amended effective April 29, 2002 (29:8 Md. R. 700)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-3 adopted effective November 24, 2005 (32:23 Md. R. 1826)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, C amended effective September 20, 2010 (37:19 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C and D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective July 1, 1987 (14:13 Md. R. 1474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended as an emergency provision effective March 13, 2009 (36:8 Md. R. 591); emergency status expired July 30, 2009</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective July 27, 2009 (36:15 Md. R. 1165); September 20, 2010 (37:19 Md. R. 1284); October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended as an emergency provision effective May 1, 1983 (10:7 Md. R. 632); adopted permanently effective May 9, 1983 (10:9 Md. R. 791)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1382); amended permanently effective November 1, 1992 (19:21 Md. R. 1891)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1C amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1C, E amended and G adopted effective November 12, 1990 (17:21 Md. R. 2529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1D amended effective October 8, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective September 10, 1994 (11:8 Md. R. 1584) June 2, 1997 (24:11 Md. R. 793)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective August 8, 1988 (15:16 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective September 10, 1984 (11:18 Md. R. 1584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 repealed and new Regulation .13 adopted effective March 19, 2012 (39:5 Md. R. 382)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13C amended effective August 8, 1988 (15:16 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective August 8, 1988 (15:16 Md. R. 1914)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended and recodified to Regulations .14 and .14-1 effective December 1, 1992 (19:23 Md. R. 2041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended as an emergency provision effective May 1, 1984 (11:10 Md. R. 858); emergency status expired August 28, 1984</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective August 29, 1984 (11:17 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective August 8, 1988 (15:16 Md. R. 1914); July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended as an emergency provision effective October 13, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1993 (20:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A-3 amended as an emergency provision effective November 12, 2002 (29:24 Md. R. 1915); amended permanently effective February 17, 2003 (30:3 Md. R. 179)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective December 31, 2007 (34:26 Md. R. 2262)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 11, 2017 (44:18 Md. R. 866); May 20, 2019 (46:10 Md. R. 486); April 4, 2022 (49:7 Md. R. 465); April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 5, 2024 (51:15 Md. R. 706)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, F amended effective April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 amended effective July 21, 2025 (52:14 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective March 28, 2016 (43:6 Md. R. 406)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1D amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1M adopted effective May 7, 2018 (45:9 Md. R. 461)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-4B amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, F amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-1B amended effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-2B, C amended effective April 10, 2017 (44:7 Md. R. 355); May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-2C amended effective August 29, 2016 (43:17 Md. R. 954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-4 adopted effective April 13, 2015 (42:7 Md. R. 568)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective September 11, 2017 (44:18 Md. R. 866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-2 adopted effective April 13, 2015 (42:7 Md. R. 568)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12E adopted effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A-3 amended effective April 13, 2015 (42:7 Md. R. 568)</annotation> </annotations> </chapter> <chapter num="25" heading="Transportation Services Under the Individuals with Disabilities Education Act (IDEA)"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(3)"> <text>“Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.02.</text> </paragraph> <paragraph num="(4)"> <text>“Individualized education program (IEP)” means a written description of special education and related services developed by a multidisciplinary team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.09.</text> </paragraph> <paragraph num="(5)"> <text>“Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.02.</text> </paragraph> <paragraph num="(6)"> <text>“Individuals with Disabilities Education Act (IDEA)” means the federal statute which provides for a free appropriate public education (FAPE) for children with disabilities from ages 3 to 21 and early intervention services for infants and toddlers with developmental delay, from birth to age 3.</text> </paragraph> <paragraph num="(7)"> <text>“Infants and toddlers with disabilities” means children from birth through 2 years old who are eligible for early intervention services, as documented by appropriate qualified personnel as defined in COMAR 13A.13.01.02.</text> </paragraph> <paragraph num="(8)"> <text>“Local education agency (LEA)” means a local public school district.</text> </paragraph> <paragraph num="(9)"> <text>“Local lead agency (LLA)” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the Office for Children.</text> </paragraph> <paragraph num="(10)"> <text>“Maryland State Department of Education (MSDE)” means the Department established by Education Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Multidisciplinary” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the individualized family service plan or individualized education program.</text> </paragraph> <paragraph num="(13)"> <text>“Multidisciplinary team” means a group convened and conducted by the provider to develop the participant's IEP, which is composed of the child's parent or parents, the child's teacher, and relevant service providers as indicated in COMAR 13A.05.01.08A.</text> </paragraph> <paragraph num="(14)"> <text>“Office for Children” means the Office for Children established under Executive Order 01.01.2006.03.</text> </paragraph> <paragraph num="(15)"> <text>“Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child's welfare, or a surrogate parent for those cases when:</text> <paragraph num="(a)"> <text>A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent;</text> </paragraph> <paragraph num="(b)"> <text>An individual cannot be identified with responsibility for a child's welfare; or</text> </paragraph> <paragraph num="(c)"> <text>The child is a ward of the State.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Participant” means a Medical Assistance recipient who is eligible for Medical Assistance reimbursement for transportation services under IDEA.</text> </paragraph> <paragraph num="(17)"> <text>“Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(18)"> <text>“Provider” means a local education agency, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation stated in Regulation .03 of this chapter, to provide transportation services under IDEA.</text> </paragraph> <paragraph num="(19)"> <text>“State-operated education agency” means a State agency that operates education programs for children with disabilities in accordance with COMAR 13A.05.01.</text> </paragraph> <paragraph num="(20)"> <text>“State-supported education agency” means an entity accredited by the Maryland State Board of Education to operate a school in accordance with COMAR 13A.09.10.</text> </paragraph> <paragraph num="(21)"> <text>“Transportation” means transportation services provided pursuant to COMAR 13A.06.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure and Certification."> <paragraph num="A."> <text>Providers shall meet the requirements of COMAR 13A.06.07.</text> </paragraph> <paragraph num="B."> <text>Providers shall meet all the requirements of the jurisdiction in which they operate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>Providers shall meet all requirements for participation in the Program stated in COMAR 10.09.36.03 and COMAR 13A.06.07.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in §B of this regulation when the services are provided to a child:</text> <paragraph num="(1)"> <text>Eligible for services under IDEA;</text> </paragraph> <paragraph num="(2)"> <text>Who is an eligible Medicaid recipient;</text> </paragraph> <paragraph num="(3)"> <text>Who was transported to or from a Medicaid-covered service under IDEA;</text> </paragraph> <paragraph num="(4)"> <text>Whose transportation and Medicaid-covered service or services are included on the child's IEP or IFSP.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following services are covered under this chapter:</text> <paragraph num="(1)"> <text>Transportation to or from a school where a Medicaid-covered IDEA service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Transportation to or from a site where a Medicaid Early Intervention-covered IDEA service is provided; and</text> </paragraph> <paragraph num="(3)"> <text>Transportation between a school and a Medicaid-covered IDEA service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>To participate in the Program as a provider of transportation services under IDEA, a provider shall be a local education agency, a local lead agency, a State-operated education agency, or State-supported education agency.</text> </paragraph> <paragraph num="B."> <text>Providers shall only bill the Program for transportation services on dates when other Medicaid covered services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An enrolled provider shall submit a request for payment of services rendered and completed under this chapter according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall submit a request for payment in the manner specified by the Department. The completed form shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, location, and provider number; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Program may not make direct payment to the participant.</text> </paragraph> <paragraph num="C."> <text>Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Reimbursement for transportation services shall be $12.50 per one way trip, of which the State portion is certified by the Maryland State Department of Education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement is as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Interpretive regulations are those set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective February 12, 1997 (24:5 Md. R. 391); adopted permanently effective May 19, 1997 (24:10 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 18, 2006 (33:25 Md. R. 1951)</annotation> </annotations> </chapter> <chapter num="26" heading="Community Based Services for Developmentally Disabled Individuals Pursuant to a 1915(c) Waiver"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Alternative living unit” means a residence that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of developmental disabilities, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits not more than 3 individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per unit per week.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Appropriate evaluation” means the assessment of an individual by qualified developmental disabilities professionals using accepted professional standards to document the presence of a:</text> <paragraph num="(a)"> <text>Developmental disability as defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Severe, chronic disability that qualifies the individual for support services as defined in Health-General Article, §7-403(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Chronic care facility” means an institution which:</text> <paragraph num="(a)"> <text>Falls within the jurisdiction of Health-General Article, §19-307(a)(1)(ii), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Day habilitation services” means a program of habilitation and health-related services which is routinely provided during the day in a community setting for a minimum of 30 hours per week, not less than 5 days per week, according to an individually designed and implemented plan of services. On one of the 5 days the program may be provided for not less than 4 hours. The habilitation program may include scheduled training or skills development activities which are conducted at sites away from the day habilitation services center.</text> </paragraph> <paragraph num="(5)"> <text>“Day habilitation services center” means a facility or a site which provides day habilitation services to individuals with developmental disabilities who do not require 24-hour inpatient care, but who, due to the degree of disability, are not capable of full-time independent living.</text> </paragraph> <paragraph num="(6)"> <text>“Department” has the meaning Maryland Department of Health as stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(7)"> <text>“Developmental Disabilities Administration (DDA)” means that agency of the Maryland Department of Health which, under Health-General Article, Title 7, is charged with the responsibility for providing services to persons who are developmentally or otherwise disabled.</text> </paragraph> <paragraph num="(8)"> <text>“Developmental disability” means a severe chronic disability of an individual that:</text> <paragraph num="(a)"> <text>Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments;</text> </paragraph> <paragraph num="(b)"> <text>Is manifested before the individual attains the age of 22;</text> </paragraph> <paragraph num="(c)"> <text>Is likely to continue indefinitely;</text> </paragraph> <paragraph num="(d)"> <text>Results in an inability to live independently without external support or continuing and regular assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Reflects the need for a combination and sequence of special interdisciplinary or generic care, treatment, or other services that are individually planned and coordinated for the individual.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Environmental modifications” means physical adaptation to a community residence, when documented in the Individualized Service Plan as being necessary to make the residence accessible and to meet the needs of the waiver participant being served in that setting.</text> </paragraph> <paragraph num="(10)"> <text>“Group home” means a residence that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of developmental disability, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits at least 4 but not more than 8 individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per home, per week.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Habilitation services” means a program which assists an individual to acquire and maintain those life skills that enable the individual to cope more effectively with the demands of the individual's own person and environment, and to raise the level of the individual's physical, mental, social, and vocational functioning including, but not limited to, programs of treatment with training in self-help, daily living, and survival skills.</text> </paragraph> <paragraph num="(12)"> <text>Home.</text> <paragraph num="(a)"> <text>“Home” means a house or apartment:</text> <paragraph num="(i)"> <text>Which is rented or owned by the waiver participant or the waiver participant's family or proponent;</text> </paragraph> <paragraph num="(ii)"> <text>Which may be held in trust for the waiver participant, or the waiver participant may be a roommate without appearing on a lease or title; and</text> </paragraph> <paragraph num="(iii)"> <text>Where the waiver participant lives with not more than two other unrelated waiver participants.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Home” does not mean a house or apartment that is owned or rented by a provider, although the provider may be a guarantor of rental or mortgage payments.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Home and Community Based Services Waiver for the Developmentally Disabled” means the document and any amendments to it submitted by the single State agency for Title XIX and approved by the Secretary of Health and Human Services which authorize the waiver of statutory requirements limiting coverage for home and community based services under the Medical Assistance Program's State Plan.</text> </paragraph> <paragraph num="(14)"> <text>“Individual family care home (IFC)” means a private, single family residence licensed by the Department which:</text> <paragraph num="(a)"> <text>Under supervision, provides a home for individuals with developmental disabilities in a family atmosphere; and</text> </paragraph> <paragraph num="(b)"> <text>Provides habilitation services for one to three individuals who are not related to the caregiver.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Individual Habilitation Plan (IHP)” means the written plan of specific action as specified in COMAR 10.22.05, which is developed and modified by an appropriately constituted interdisciplinary team.</text> </paragraph> <paragraph num="(16)"> <text>“Individualized Service Plan (ISP)” means the document serving as the basis for effective and efficient services coordination for the client, developed by an interdisciplinary team with the input and approval of the client, or the client's representative, as appropriate, focusing upon the broad service areas needed by the client, and recorded and managed by the client's service coordinator.</text> </paragraph> <paragraph num="(17)"> <text>“Intensive behavior management” means a specialized program designed to serve waiver participants who have been identified as having emotional disturbance or maladaptive behavior of sufficient severity to prevent or jeopardize community living.</text> </paragraph> <paragraph num="(18)"> <text>“Interdisciplinary team” means a group convened by the waiver participant's service coordinator, which meets to design effective, efficient individualized plans and programs, with membership comprised of, but not limited to, the waiver participant, the waiver participant's family or representative, the waiver participant's service coordinator, representatives of providers, individuals with various professional skills which are relevant to the needs of the waiver participant, and other human services staff.</text> </paragraph> <paragraph num="(19)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(20)"> <text>“Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living.</text> </paragraph> <paragraph num="(21)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(22)"> <text>“Nursing facility” means a facility or a distinct part of a facility which is participating in the Medical Assistance Program as a nursing facility provider under COMAR 10.09.10 or 10.09.11.</text> </paragraph> <paragraph num="(23)"> <text>“Physician” means an individual licensed to practice medicine in the state in which services are provided.</text> </paragraph> <paragraph num="(24)"> <text>“Plan of care” means the written, individualized plan of care developed for a waiver participant in accordance with the requirements under COMAR 10.09.48, 10.22.09, or 10.22.11.</text> </paragraph> <paragraph num="(25)"> <text>“Program” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(26)"> <text>“Provider” means an agency which is licensed or certified to furnish covered services under these regulations through an appropriate agreement with the Department.</text> </paragraph> <paragraph num="(27)"> <text>“Provider agreement” means the contract between the Department and the provider specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation is allowed.</text> </paragraph> <paragraph num="(28)"> <text>“Qualified developmental disabilities professional (QDPP)” means an individual who:</text> <paragraph num="(a)"> <text>Is a registered nurse, physician, or an individual with a bachelor's degree in a relevant discipline which may include, but not be limited to:</text> <paragraph num="(i)"> <text>Occupational therapy,</text> </paragraph> <paragraph num="(ii)"> <text>Physical therapy,</text> </paragraph> <paragraph num="(iii)"> <text>Psychology,</text> </paragraph> <paragraph num="(iv)"> <text>Social work,</text> </paragraph> <paragraph num="(v)"> <text>Recreation,</text> </paragraph> <paragraph num="(vi)"> <text>Education; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has a minimum of 1 year full-time or equivalent experience working directly with persons with an intellectual disability or other developmental disability.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(30)"> <text>“Residential habilitation services” means that training provided in a group home, alternative living unit, or individual family care home to a waiver participant which promotes skills necessary for maximum independence in daily activities of living.</text> </paragraph> <paragraph num="(31)"> <text>“Residential option services” means one or more of the services described in Regulation .08-2 of this chapter which are intended to assist eligible waiver participants, regardless of the nature and severity of their disability, to live independently and successfully in the community by assisting them to perform activities of daily living and enabling them to live in homes of their choice, receive services from providers of their choice, and take into account the use of community resources and natural supports.</text> </paragraph> <paragraph num="(32)"> <text>“Respite care” means a service for waiver participants designed to provide time-limited and temporary relief for primary informal caregivers from the ongoing responsibility of providing care for waiver participants, as well as to provide a back-up service system in the event of a crisis or emergency involving a primary informal caregiver.</text> </paragraph> <paragraph num="(33)"> <text>“Room and board” means rent or mortgage, utilities, and food.</text> </paragraph> <paragraph num="(34)"> <text>“Service coordinator” means a case management professional who is a qualified developmental disabilities professional (QDDP) selected by the client and employed by a service coordination provider under this chapter to assist the client in gaining more efficient and effective access to the service delivery system.</text> </paragraph> <paragraph num="(35)"> <text>“Services coordination” means a service that consists of the following 3 major functions that are designed to assist an individual in obtaining the needed services and programs that the individual desires in order to gain as much control over the individual's own life as possible:</text> <paragraph num="(a)"> <text>Planning services;</text> </paragraph> <paragraph num="(b)"> <text>Coordinating services; and</text> </paragraph> <paragraph num="(c)"> <text>Monitoring service delivery to the individual.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“State residential center” means a place that:</text> <paragraph num="(a)"> <text>Is owned and operated by this State;</text> </paragraph> <paragraph num="(b)"> <text>Provides residential services for individuals with an intellectual disability and who, because of an intellectual disability, require specialized living arrangements; and</text> </paragraph> <paragraph num="(c)"> <text>Admits 9 or more individuals with a diagnosis of an intellectual disability.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Supported employment” means paid work in a variety of regular work settings in which persons without disabilities are employed, and which are especially designed for individuals with developmental disabilities facing severe impediments to employment due to the nature and complexity of their disabilities, irrespective of age or vocational potential.</text> </paragraph> <paragraph num="(38)"> <text>“Waiver participant” means a recipient who meets the eligibility requirements of these regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>Providers of residential habilitation services shall be licensed pursuant to COMAR 10.22.03 or 10.22.14.</text> </paragraph> <paragraph num="B."> <text>Providers of day habilitation or supported employment services shall be licensed pursuant to COMAR 10.22.12 or 10.22.13.</text> </paragraph> <paragraph num="C."> <text>Providers of services coordination services shall be licensed by the Department pursuant to COMAR 10.22.09.</text> </paragraph> <paragraph num="D."> <text>Providers of residential option services shall be licensed pursuant to COMAR 10.22.11.04.</text> </paragraph> <paragraph num="E."> <text>Providers of intensive behavior management shall be:</text> <paragraph num="(1)"> <text>Licensed by the Department to provide services for developmentally disabled individuals; or</text> </paragraph> <paragraph num="(2)"> <text>Approved by the DDA as qualified to render services in accordance with COMAR 10.22.10.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Providers of any service covered under this chapter, with the exception of medical day care services, may be issued a deemed status license by the Director of DDA, in accordance with the deemed status provisions in Health-General Article, §7-903(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>Providers of medical day care services shall be licensed pursuant to COMAR 10.12.04.</text> </paragraph> <paragraph num="H."> <text>DDA shall comply with all applicable provisions of COMAR 10.21 when:</text> <paragraph num="(1)"> <text>Enrolling providers for services covered under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Authorizing a provider to serve greater numbers of waiver participants; or</text> </paragraph> <paragraph num="(3)"> <text>Transferring authorized positions for waiver participants from one provider to another provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Medical Assistance Program are that the providers:</text> <paragraph num="(1)"> <text>Meet all conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Meet the licensure requirements as provided in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Have a provider agreement in effect with the Developmental Disabilities Administration and the Medical Assistance Program;</text> </paragraph> <paragraph num="(4)"> <text>Verify the licenses of all service agencies with whom they contract and have a copy of the same available for inspection;</text> </paragraph> <paragraph num="(5)"> <text>Verify the licenses and credentials of all professionals whom they employ or with whom they contract and have a copy of same available for inspection;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a written clinical record for each waiver participant which includes:</text> <paragraph num="(a)"> <text>A copy of the waiver participant's signed statement indicating the alternatives of care locations offered to him or her, and his or her choice;</text> </paragraph> <paragraph num="(b)"> <text>Date of:</text> <paragraph num="(i)"> <text>Discharge from a State residential center or a nursing or chronic care facility into the services covered under this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>Diversion from a State residential center or chronic care facility into the services covered under this chapter; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Have waiver participants reevaluated annually by the interdisciplinary team.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services coordination providers shall submit individualized service plans to the DDA or its designee.</text> </paragraph> <paragraph num="C."> <text>Environmental Modifications.</text> <paragraph num="(1)"> <text>Residential habilitation or residential option services providers shall provide environmental modifications as necessary to meet the needs of waiver participants after receiving prior authorization from DDA.</text> </paragraph> <paragraph num="(2)"> <text>Environmental modifications shall be:</text> <paragraph num="(a)"> <text>Provided by the residential habilitation or residential option services provider in getting a residence ready to be occupied; and</text> </paragraph> <paragraph num="(b)"> <text>Performed in accordance with applicable codes of the locality.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Respite Care.</text> <paragraph num="(1)"> <text>Residential habilitation or residential option services providers shall provide respite care as necessary to meet the needs of waiver participants.</text> </paragraph> <paragraph num="(2)"> <text>Respite care services shall be received in a:</text> <paragraph num="(a)"> <text>State residential center; or</text> </paragraph> <paragraph num="(b)"> <text>Community residence:</text> <paragraph num="(i)"> <text>Operated by a provider of residential habilitation services; and</text> </paragraph> <paragraph num="(ii)"> <text>Licensed by the State, in accordance with COMAR 10.22.03.02A(9)(b) and (c), to provide respite care.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Medical day care providers:</text> <paragraph num="(1)"> <text>Shall meet the requirements of COMAR 10.09.07; and</text> </paragraph> <paragraph num="(2)"> <text>Are exempt from meeting the requirements of Regulation .18D of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services for Services Coordination."> <text>The Department shall reimburse for services coordination which shall include the following:</text> <paragraph num="A."> <text>Convening the interdisciplinary team and conducting the team meeting for the development and revision of the ISP;</text> </paragraph> <paragraph num="B."> <text>Assisting the waiver participant in identifying, negotiating, and obtaining needed services that are agreed upon and specified in the ISP;</text> </paragraph> <paragraph num="C."> <text>Arranging, coordinating, and monitoring the delivery of services specified in the ISP;</text> </paragraph> <paragraph num="D."> <text>Reassessing or arranging for the periodic reassessment of the waiver participant's needs and services;</text> </paragraph> <paragraph num="E."> <text>Participating in the development of the waiver participant's initial IHP;</text> </paragraph> <paragraph num="F."> <text>Participating in reviews of the waiver participant's IHP; and</text> </paragraph> <paragraph num="G."> <text>Assisting the waiver participant in maximizing the use of the following sources of services and equipment in an effort to achieve the least costly, yet appropriate, delivery of services to the waiver participant:</text> <paragraph num="(1)"> <text>Services provided at no cost by governmental or charitable agencies, such as the Department of Social Services or the Department of Vocational Rehabilitation,</text> </paragraph> <paragraph num="(2)"> <text>Services covered by the Program or other third-party payors,</text> </paragraph> <paragraph num="(3)"> <text>Generic services covered by other programs,</text> </paragraph> <paragraph num="(4)"> <text>Services that can be paid for with the waiver participant's funds.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services for Residential Habilitation."> <paragraph num="A."> <text>The Department shall reimburse residential habilitation services providers for those services listed below, exclusive of room and board. These regulations do not limit payments, within the fiscal guidelines of the Department, for room, board, and normal living expenses for waiver participants.</text> </paragraph> <paragraph num="B."> <text>Habilitation. The services shall be provided as required and recommended in the IHP. Residential habilitation services providers shall provide, as a minimum, the following:</text> <paragraph num="(1)"> <text>A program of habilitation which shall:</text> <paragraph num="(a)"> <text>Be specified in the IHP,</text> </paragraph> <paragraph num="(b)"> <text>Provide training in the development of self-help, daily living, self-advocacy, and survival skills, and</text> </paragraph> <paragraph num="(c)"> <text>Use the principles of the Developmental Model;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mobility training to maximize use of public transportation in traveling to and from work training or day programs, work sites, community services, and recreational sites;</text> </paragraph> <paragraph num="(3)"> <text>Training and assistance in developing appropriate social behaviors which are normative in the surrounding community such as conducting one's self appropriately in restaurants, on public transportation vehicles, in recreational facilities, and in stores and other public places;</text> </paragraph> <paragraph num="(4)"> <text>Training and assistance in developing patterns of living, activities, and routines which are appropriate to the waiver participant's age and the practices of the surrounding community and which are consistent with the waiver participant's interest and capabilities;</text> </paragraph> <paragraph num="(5)"> <text>Training and assistance in developing basic safety skills;</text> </paragraph> <paragraph num="(6)"> <text>Training and assistance in developing competency in housekeeping skills including, but not limited to, meal preparation, laundry, and shopping;</text> </paragraph> <paragraph num="(7)"> <text>Training and assistance in developing competency in personal care skills such as bathing, toileting, dressing, and grooming;</text> </paragraph> <paragraph num="(8)"> <text>Training and assistance in developing health care skills, including but not limited to, maintaining proper dental hygiene, carrying out the recommendations of the dentist or physician, appropriate use of medications, application of basic first aid, arranging medical and dental appointments, and summoning emergency assistance;</text> </paragraph> <paragraph num="(9)"> <text>Training and assistance to waiver participants in developing money management skills which include recognition of currency, making change, bill paying, check writing, record keeping, budgeting, and saving;</text> </paragraph> <paragraph num="(10)"> <text>Supervision of individuals as appropriate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medical. Medical services provided shall be under the direction of a physician and shall include the following:</text> <paragraph num="(1)"> <text>Evaluation, diagnosis, and treatment;</text> </paragraph> <paragraph num="(2)"> <text>Consultation with the waiver participant and his or her family, staff members, and personal physician, if any;</text> </paragraph> <paragraph num="(3)"> <text>Participation in the development of the initial IHP;</text> </paragraph> <paragraph num="(4)"> <text>Monitoring, reevaluation and follow-up of medical services as appropriate;</text> </paragraph> <paragraph num="(5)"> <text>Referral of waiver participants who require additional medical treatment and services which are not available at the residential services site.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Occupational Therapy. Occupational therapy services shall be provided that are required and recommended in the IHP and shall include:</text> <paragraph num="(1)"> <text>Specifications of the treatment to be rendered, the frequency and duration of that treatment, and the expected results;</text> </paragraph> <paragraph num="(2)"> <text>Evaluation and reevaluation of the waiver participant's level of functioning through the use of standardized or professionally accepted diagnostic methods;</text> </paragraph> <paragraph num="(3)"> <text>Development and delivery of appropriate treatment programs which are designed to significantly improve a waiver participant's level of functioning within a reasonable period of time;</text> </paragraph> <paragraph num="(4)"> <text>Selection and teaching of task-oriented therapeutic activities designed to restore physical functioning;</text> </paragraph> <paragraph num="(5)"> <text>Improvement of mobility skills.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Psychiatric. Psychiatric services shall be provided as recommended in the IHP, under the direction of a board certified psychiatrist, and shall include:</text> <paragraph num="(1)"> <text>Treatment and prevention of behavioral or emotional disorders which result from psychiatric or neurological conditions;</text> </paragraph> <paragraph num="(2)"> <text>Written assessment of the waiver participant's mental and emotional status;</text> </paragraph> <paragraph num="(3)"> <text>Consultation with the waiver participant's personal physician, and other individuals involved in the care of the waiver participant as appropriate;</text> </paragraph> <paragraph num="(4)"> <text>Periodic monitoring and follow-up of waiver participant's progress.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Psychological. Psychological services shall be provided as required and recommended in the IHP and shall include:</text> <paragraph num="(1)"> <text>A written evaluation that includes use of psychometric data, provided that there is a significant change in the waiver participant's level of functioning, or behavior, or both;</text> </paragraph> <paragraph num="(2)"> <text>Interviews and consultations with the waiver participant, family, and other pertinent individuals;</text> </paragraph> <paragraph num="(3)"> <text>Participation in the development of the initial IHP, monitoring, reevaluation, and follow-up of specific individual programs as appropriate;</text> </paragraph> <paragraph num="(4)"> <text>Assessment and treatment related to the emotional needs of the waiver participant;</text> </paragraph> <paragraph num="(5)"> <text>Consultation with staff;</text> </paragraph> <paragraph num="(6)"> <text>Development and implementation of behavior modification programs.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Physical Therapy.</text> <paragraph num="(1)"> <text>Physical therapy services shall be provided as required and recommended in the IHP which specify:</text> <paragraph num="(a)"> <text>Part or parts of the body to be treated;</text> </paragraph> <paragraph num="(b)"> <text>Type of modalities or treatments to be rendered;</text> </paragraph> <paragraph num="(c)"> <text>Expected results of physical therapy treatments;</text> </paragraph> <paragraph num="(d)"> <text>Frequency and duration of treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The needs assessment shall indicate services which are of a diagnostic, habilitative, therapeutic, or maintenance nature to prevent further deterioration.</text> </paragraph> <paragraph num="(3)"> <text>Services shall meet accepted standards of medical practice, with developed time frames for effective professional treatment.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Social. Social services shall be provided as required and recommended in the IHP and shall include:</text> <paragraph num="(1)"> <text>Identification of the waiver participant's social needs;</text> </paragraph> <paragraph num="(2)"> <text>Individual counseling to assist the waiver participant's adaption to the environment;</text> </paragraph> <paragraph num="(3)"> <text>Family and group counseling to assist and facilitate the waiver participant's adjustment.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Speech Pathology and Audiology. Speech pathology and audiology services shall be provided as required and recommended in the IHP and shall include:</text> <paragraph num="(1)"> <text>Maximization of communication skills;</text> </paragraph> <paragraph num="(2)"> <text>Screening, evaluation, counseling, treatment, habilitation, or rehabilitation of waiver participants with hearing, language, or speech handicaps;</text> </paragraph> <paragraph num="(3)"> <text>Coordination of interdisciplinary goals related to hearing and speech needs;</text> </paragraph> <paragraph num="(4)"> <text>Consultation with staff regarding the waiver participant's programs.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Nursing. Nursing services shall be provided which:</text> <paragraph num="(1)"> <text>Are preauthorized by DDA as being medically necessary and not otherwise covered by the Program;</text> </paragraph> <paragraph num="(2)"> <text>Are rendered under the direction of a physician;</text> </paragraph> <paragraph num="(3)"> <text>Are required and recommended in the waiver participant's ISP; and</text> </paragraph> <paragraph num="(4)"> <text>May include:</text> <paragraph num="(a)"> <text>Meeting with provider's staff to discuss how the medical services that are identified in the ISP will be implemented,</text> </paragraph> <paragraph num="(b)"> <text>Education, supervision, and training of waiver participants in health-related matters, and</text> </paragraph> <paragraph num="(c)"> <text>Short-term or intermittent skilled or unskilled nursing services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services for Day Habilitation."> <paragraph num="A."> <text>Day habilitation services shall be provided that are required and recommended in the waiver participant's IHP by licensed day habilitation programs and shall include the services listed in Regulation .05 of this chapter and in §B—D of this regulation.</text> </paragraph> <paragraph num="B."> <text>Transportation.</text> <paragraph num="(1)"> <text>Transportation services shall be arranged for participants by the day habilitation services center staff. The center shall maximize the use of the following types of transportation services in an effort to achieve the least costly, yet appropriate, means of transportation for its participants:</text> <paragraph num="(a)"> <text>Persons who live within walking distance of the day habilitation services center, and who are sufficiently mobile, shall be encouraged to walk;</text> </paragraph> <paragraph num="(b)"> <text>Transportation supplied by family, friends, neighbors, or volunteers;</text> </paragraph> <paragraph num="(c)"> <text>Free community transportation services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After every effort made by the center to procure the types of transportation mentioned above has failed, the Department shall reimburse the day habilitation services provider for the waiver participant's traveling costs, to and from the center, by car, van, or specially equipped vehicles. It shall be the responsibility of the center to:</text> <paragraph num="(a)"> <text>Arrange for use of public transportation, when appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Arrange special low-cost contract agreements with transportation providers to meet the transportation needs of the participants;</text> </paragraph> <paragraph num="(c)"> <text>Group participants, when possible, not to exceed the seating capacity, in the same van or specially equipped vehicle, to minimize the cost of transportation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Records shall clearly indicate both a primary transportation plan and an alternate plan. The center shall keep accurate records which include the type of transportation used by each participant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nutrition.</text> <paragraph num="(1)"> <text>Arrangements shall be made for participants to eat well balanced, palatable, properly prepared meals of sufficient quality and quantity.</text> </paragraph> <paragraph num="(2)"> <text>Dietary counseling and education shall be available to all participants.</text> </paragraph> <paragraph num="(3)"> <text>Nutrition services do not include a full meal regimen.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prevocational Services.</text> <paragraph num="(1)"> <text>“Prevocational services” means those plans and interventions to assist a waiver participant in acquiring and maintaining basic work and work-related skills. The services are designed to prepare the waiver participant for unpaid or paid employment, but are not job task oriented. Prevocational services have habilitative objectives rather than explicit employment objectives.</text> </paragraph> <paragraph num="(2)"> <text>Prevocational services include:</text> <paragraph num="(a)"> <text>Training the waiver participant to follow directions, adapt to work routines, and carry out assigned duties in an effective and efficient manner;</text> </paragraph> <paragraph num="(b)"> <text>Helping the waiver participant to acquire appropriate attitudes and work habits, including instruction in socially appropriate behaviors on and off the job site;</text> </paragraph> <paragraph num="(c)"> <text>Assisting the waiver participant to adjust to the productive and social demands of the workplace;</text> </paragraph> <paragraph num="(d)"> <text>Familiarizing the waiver participant with job production and performance requirements;</text> </paragraph> <paragraph num="(e)"> <text>Providing transportation between the waiver participant's place of residence and the workplace when other forms of transportation are unavailable or inaccessible;</text> </paragraph> <paragraph num="(f)"> <text>Providing mobility training, including the use of public transit and para-transit systems; and</text> </paragraph> <paragraph num="(g)"> <text>Instructing waiver participants in appropriate use of job-related facilities such as break areas, lunch rooms or cafeterias, and restrooms.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prevocational services are covered by the Program if:</text> <paragraph num="(a)"> <text>The waiver participant previously resided in a State residential center or nursing facility and has a demonstrated earning capacity of less than 50 percent of the federal minimum wage, as determined in accordance with certification standards promulgated by the U.S. Department of Labor;</text> </paragraph> <paragraph num="(b)"> <text>The services are an essential component of the waiver participant's IHP;</text> </paragraph> <paragraph num="(c)"> <text>Work productivity is a secondary or tertiary goal of these services, subordinate to the acquisition and retention of work and work-related skills;</text> </paragraph> <paragraph num="(d)"> <text>The provider's program is certified by the U.S. Department of Labor as a “work activity center”, in accordance with the Fair Labor Standards Act, §14(c); and</text> </paragraph> <paragraph num="(e)"> <text>The waiver participant is engaging in compensable work as a necessary but subordinate part of the receipt of habilitation services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Covered Services for Environmental Modifications."> <paragraph num="A."> <text>Environmental modifications shall be provided on a limited, one-time-only basis to the extent necessary to enable waiver participants with physical infirmities or disabilities to live safely in community homes as an alternative to institutionalization.</text> </paragraph> <paragraph num="B."> <text>The environmental modifications are limited to:</text> <paragraph num="(1)"> <text>Installation of bathing and toilet-area grab bars in the home of a waiver participant who has physical infirmities or disabilities, when these mechanisms are not already installed;</text> </paragraph> <paragraph num="(2)"> <text>Minor remodeling of the home to make it physically accessible for a waiver participant;</text> </paragraph> <paragraph num="(3)"> <text>Construction of access ramps and railings for a waiver participant who uses a wheelchair or who has limited ambulatory ability;</text> </paragraph> <paragraph num="(4)"> <text>Installation of detectable warnings on walking surfaces;</text> </paragraph> <paragraph num="(5)"> <text>Adaptations to the electrical, telephone, and lighting systems;</text> </paragraph> <paragraph num="(6)"> <text>Life-saving equipment for waiver participants;</text> </paragraph> <paragraph num="(7)"> <text>Widening of doorways and halls for wheelchair use; and</text> </paragraph> <paragraph num="(8)"> <text>Installation of chair glides along stairways.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The services in this regulation are covered only if prior authorization is received from DDA, to assure that the proposed modifications are necessary to meet the waiver participant's needs and that the modifications conform with the requirements in these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Covered Services for Respite Care."> <paragraph num="A."> <text>Respite care may only be provided to waiver participants who receive residential habilitation or residential option services in their home or in an individual family care home.</text> </paragraph> <paragraph num="B."> <text>When respite care is received in a:</text> <paragraph num="(1)"> <text>State residential center, it is limited to a total of 45 days within any 12-month period;</text> </paragraph> <paragraph num="(2)"> <text>Community residence, it is limited to 14 consecutive days at a time and to a total of 28 days within any 12-month period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Room and board is included in the residential habilitation or residential option services provider's reimbursement for respite care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-1" heading="Covered Services for Supported Employment."> <paragraph num="A."> <text>Supported employment services are available to waiver participants:</text> <paragraph num="(1)"> <text>Who previously resided in a State residential center or nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>For whom competitive employment at or above the minimum wage is unlikely; and</text> </paragraph> <paragraph num="(3)"> <text>Who, because of their disability, need ongoing post-employment support to perform in a work setting.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supported employment services are designed to assist a waiver participant with accessing and maintaining paid employment. The services shall be provided as required and recommended in the waiver participant's ISP, as an alternative model of day habilitation.</text> </paragraph> <paragraph num="C."> <text>Supported employment services include:</text> <paragraph num="(1)"> <text>Individualized assessment and development of employment-related goals and objectives;</text> </paragraph> <paragraph num="(2)"> <text>Individualized and group counseling;</text> </paragraph> <paragraph num="(3)"> <text>Individualized job development, placement, and work adjustment services that produce an appropriate job match between the waiver participant and the waiver participant's employer;</text> </paragraph> <paragraph num="(4)"> <text>On-the-job training in work and work-related skills required to perform the job;</text> </paragraph> <paragraph num="(5)"> <text>Ongoing evaluation, supervision, and monitoring of the waiver participant's performance on the job which are required because of the waiver participant's disabilities, but which do not include supervisory activities rendered as a normal part of the business setting;</text> </paragraph> <paragraph num="(6)"> <text>Ongoing support services necessary to assure job retention;</text> </paragraph> <paragraph num="(7)"> <text>Training in related skills essential to obtaining and retaining employment, such as the effective use of community resources and break or lunch areas, and transportation and mobility training;</text> </paragraph> <paragraph num="(8)"> <text>Transportation between the waiver participant's place of residence and the workplace, when other forms of transportation are unavailable or inaccessible;</text> </paragraph> <paragraph num="(9)"> <text>Adaptive equipment necessary to obtain and retain employment; and</text> </paragraph> <paragraph num="(10)"> <text>Community integration activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-2" heading="Covered Services for Residential Option Services."> <paragraph num="A."> <text>Residential option services are available as an alternative to residential habilitation for those waiver participants who:</text> <paragraph num="(1)"> <text>Have followed DDA's application procedures according to COMAR 10.22.11;</text> </paragraph> <paragraph num="(2)"> <text>Are determined by DDA to be able to live safely in a home of the waiver participant's choosing and who are in need of at least one residential option service; and</text> </paragraph> <paragraph num="(3)"> <text>Elect, or have an authorized representative elect in the waiver participant's behalf, to receive residential option services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>These services shall be provided, as required and recommended in the waiver participant's ISP, as being appropriate and necessary to assist the waiver participant in living successfully in a home of the waiver participant's choosing. Residential option services include the services specified in Sec. C--E of this regulation.</text> </paragraph> <paragraph num="C."> <text>Personal Assistance.</text> <paragraph num="(1)"> <text>Services under COMAR 10.09.20 may not be reimbursed for a waiver participant receiving personal assistance under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Personal assistance services provide necessary assistance for waiver participants living in their own homes or family homes to meet their daily living needs and to ensure adequate functioning in the community. They include the following services, when they do not have a habilitative objective:</text> <paragraph num="(a)"> <text>Housekeeping assistance which is directly related to the waiver participant's developmental disability and which is necessary for the waiver participant's health and well-being in the home, such as:</text> <paragraph num="(i)"> <text>Changing bed linens,</text> </paragraph> <paragraph num="(ii)"> <text>Straightening the area used by the waiver participant,</text> </paragraph> <paragraph num="(iii)"> <text>Doing the waiver participant's personal laundry and linens, and</text> </paragraph> <paragraph num="(iv)"> <text>Maintenance of kitchen area if food preparation is necessary;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Menu planning, food shopping, meal preparation, and assistance with eating;</text> </paragraph> <paragraph num="(c)"> <text>Personal hygiene and grooming, including oral and denture care, shaving, and care of skin, nails, and hair;</text> </paragraph> <paragraph num="(d)"> <text>Cleaning and maintaining adaptive devices such as wheelchairs; and</text> </paragraph> <paragraph num="(e)"> <text>Assurance of health and safety.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Support Services.</text> <paragraph num="(1)"> <text>Support services are necessary to aid the waiver participant to participate in community life as is typical in the community.</text> </paragraph> <paragraph num="(2)"> <text>Support services include the following:</text> <paragraph num="(a)"> <text>Guidance to optimize the waiver participant's capability of living in the community at home;</text> </paragraph> <paragraph num="(b)"> <text>Facilitating community participation by assisting with linkages to community activities, organizations, or associations;</text> </paragraph> <paragraph num="(c)"> <text>Assisting with budgeting, banking, tax preparation, and financial management;</text> </paragraph> <paragraph num="(d)"> <text>Assisting with accessing and managing government and community resources; and</text> </paragraph> <paragraph num="(e)"> <text>Assisting the waiver participant with securing and maintaining housing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>24-Hour Emergency Assistance.</text> <paragraph num="(1)"> <text>These emergency assistance services are utilized to provide a waiver participant with access to a highly responsive form of back-up services in the event of an emergency, without dictating that the waiver participant be subject to on-site 24-hour supervision.</text> </paragraph> <paragraph num="(2)"> <text>The access to 24-hour emergency assistance shall be adapted to the skills and needs of the waiver participant and may include the use of an emergency telephone number, a pager, or other appropriate technology.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-3" heading="Assistive Technology and Adaptive Equipment."> <paragraph num="A."> <text>This technology and equipment includes the assistive technology and adaptive equipment necessary to enable a waiver participant to live in the community and to participate in community activities, when this technology and equipment is not otherwise covered by the Program.</text> </paragraph> <paragraph num="B."> <text>The following items or services are included:</text> <paragraph num="(1)"> <text>Equipment needed to adapt the waiver participant's or family's vehicle;</text> </paragraph> <paragraph num="(2)"> <text>Purchase or rental of certain types of medical equipment to allow greater independence for a waiver participant;</text> </paragraph> <paragraph num="(3)"> <text>A prompted assisted living system for a waiver participant; and</text> </paragraph> <paragraph num="(4)"> <text>Assessments, specialized training, and upkeep and repair needed in conjunction with the use of these devices and equipment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-4" heading="Covered Services for Intensive Behavior Management."> <text>Services shall be provided in accordance with COMAR 10.22.10.</text> </regulation> <regulation prefix="Regulation" num=".08-5" heading="Covered Services for Medical Day Care."> <paragraph num="A."> <text>Unit of service means a day of care in which the participant is certified present at the medical day care center for a minimum of 4 hours.</text> </paragraph> <paragraph num="B."> <text>Medical day care services shall be provided in accordance with COMAR 10.09.07.</text> </paragraph> <paragraph num="C."> <text>Medical day care services may be covered for not more than 5 days per week.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Conditions for Reimbursement."> <text>The Department shall reimburse for services in Regulations .04—.08-5 of this chapter when they are:</text> <paragraph num="A."> <text>Provided to waiver participants;</text> </paragraph> <paragraph num="B."> <text>With the exception of medical day care services, contained in the waiver participant's plan of care, approved initially and within 12 months after that by a:</text> <paragraph num="(1)"> <text>Licensed physician;</text> </paragraph> <paragraph num="(2)"> <text>Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or</text> </paragraph> <paragraph num="(3)"> <text>Qualified developmental disabilities professional; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>With the exception of medical day care services, adequately described in the progress notes in the waiver participant's record, signed and dated by a qualified developmental disabilities professional.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Limitations."> <paragraph num="A."> <text>These regulations do not cover the following services:</text> <paragraph num="(1)"> <text>Services available to waiver participants through programs funded under the Rehabilitation Act of 1973, §110, Public Law 94-142, or Education of the Handicapped Act, §602(16) and (17);</text> </paragraph> <paragraph num="(2)"> <text>Services which are not part of a waiver participant's plan of care as established by a:</text> <paragraph num="(a)"> <text>Licensed physician;</text> </paragraph> <paragraph num="(b)"> <text>Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or</text> </paragraph> <paragraph num="(c)"> <text>Qualified developmental disabilities professional;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services which are not included in Regulations .04—.08-5 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Medical day care services which are not provided in accordance with COMAR 10.09.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Providers are not entitled to reimbursement from the Program unless the waiver participant served by that provider is certified for medical eligibility by the Department or its designee and for financial eligibility by the Department of Human Services or its designee.</text> </paragraph> <paragraph num="C."> <text>Providers of services coordination services pursuant to these regulations may not be providers of any other service covered under this chapter for waiver participants.</text> </paragraph> <paragraph num="D."> <text>If the Program denies payment or requests repayment on the basis that an otherwise covered service was not programmatically necessary, the provider may not seek payment for that service from the recipient.</text> </paragraph> <paragraph num="E."> <text>Payment may not be made for the same date of service for respite care, personal assistance, and residential habilitation services rendered to a waiver participant.</text> </paragraph> <paragraph num="F."> <text>Payment may not be made for the same date of service to a residential habilitation services provider, a residential option services provider, and a personal care services provider under COMAR 10.09.20 for services rendered to a waiver participant. Qualified participants shall be given the option of residential habilitation or residential option services when they are determined to need residential services and qualify for both options.</text> </paragraph> <paragraph num="G."> <text>Payment may not be made for the same date of service for day habilitation services, supported employment services, and medical day care services under COMAR 10.09.07 rendered to a waiver participant.</text> </paragraph> <paragraph num="H."> <text>The following services shall be reimbursed only if preauthorized by DDA, or authorized by DDA after the fact in emergency situations:</text> <paragraph num="(1)"> <text>Environmental modifications as covered under Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Assistive technology and adaptive equipment as covered under Regulation .08-3 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Nursing services as covered under Regulations .05 or .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Participant Eligibility."> <paragraph num="A."> <text>Waiver participants shall meet the eligibility conditions of §B of this regulation, as well as Regulation .12 of this chapter.</text> </paragraph> <paragraph num="B."> <text>To be eligible for services under the Home and Community Based Services Waiver for the Developmentally Disabled, a person shall:</text> <paragraph num="(1)"> <text>Be a recipient who, immediately before placement pursuant to these regulations, is residing in a:</text> <paragraph num="(a)"> <text>State residential center;</text> </paragraph> <paragraph num="(b)"> <text>Nursing facility and who is determined through the Preadmission Screening Annual Resident Review (PASARR) process to:</text> <paragraph num="(i)"> <text>Have a developmental disability, and</text> </paragraph> <paragraph num="(ii)"> <text>Be in need of specialized services pursuant to 42 CFR §483.136; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Chronic care or nursing facility bed at a chronic care facility; or</text> </paragraph> <paragraph num="(d)"> <text>Community setting and who is determined by DDA to be at risk of placement in a State residential center or in a chronic care or nursing facility bed at a chronic care facility, in accordance with DDA's process for eligibility determinations and for determination of service priority categories;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be given a comprehensive evaluation as defined in Health-General Article, §7-104, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Have an approved plan of care;</text> </paragraph> <paragraph num="(4)"> <text>Be selected by the DDA based on professionally accepted assessment measures, as appropriate to participate in the waiver program;</text> </paragraph> <paragraph num="(5)"> <text>Choose, during an interpretive interview, between institutional or home and community based services;</text> </paragraph> <paragraph num="(6)"> <text>Be certified for an ICF/IID level of care and have need for active treatment pursuant to 42 CFR §435.1009.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Medical Assistance Eligibility."> <paragraph num="A."> <text>Definitions. In this regulation, the following terms have the meanings indicated:</text> <paragraph num="(1)"> <text>“Aged” means a person who is 65 years old or older.</text> </paragraph> <paragraph num="(2)"> <text>“Blind” means having a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of not greater than 20 degrees.</text> </paragraph> <paragraph num="(3)"> <text>“Child” means an individual who is younger than 21 years old.</text> </paragraph> <paragraph num="(4)"> <text>“Community spouse” means an individual who:</text> <paragraph num="(a)"> <text>Lives in the community outside a medical institution;</text> </paragraph> <paragraph num="(b)"> <text>Is not determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act; and</text> </paragraph> <paragraph num="(c)"> <text>Is married to an institutionalized spouse.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Continuous period of institutionalization” means:</text> <paragraph num="(a)"> <text>At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or</text> </paragraph> <paragraph num="(b)"> <text>A determination that a spouse meets the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which is expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months.</text> </paragraph> <paragraph num="(7)"> <text>“Institutionalized spouse” means an individual who is married to a community spouse and who:</text> <paragraph num="(a)"> <text>Is an inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or</text> </paragraph> <paragraph num="(b)"> <text>Is determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of the Social Security Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Financial eligibility for waiver participants is determined according to this regulation and COMAR 10.09.24, as cited in §§C—F of this regulation.</text> </paragraph> <paragraph num="C."> <text>Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a:</text> <paragraph num="(1)"> <text>Recipient of Supplemental Security Income (SSI); or</text> </paragraph> <paragraph num="(2)"> <text>Member of a low income family with children, as described in §1931 of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D.</text> </paragraph> <paragraph num="E."> <text>Optionally Categorically Needy.</text> <paragraph num="(1)"> <text>An individual is eligible for waiver services as optionally categorically needy, in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person.</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person.</text> </paragraph> <paragraph num="(3)"> <text>For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized, with the exceptions specified at §E(9) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to a child or an aged, blind, or disabled person who is institutionalized, with the exceptions specified at §E(9) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires.</text> </paragraph> <paragraph num="(6)"> <text>The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, with the differences specified in this regulation.</text> </paragraph> <paragraph num="(7)"> <text>Medical Assistance eligibility shall be redetermined at least every 12 months.</text> </paragraph> <paragraph num="(8)"> <text>As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or a child, or has been determined as disabled by the Social Security Administration.</text> </paragraph> <paragraph num="(9)"> <text>All provisions of COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions:</text> <paragraph num="(a)"> <text>COMAR 10.09.24.04J(1), (2), and (3);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.24.04K;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24.08G(1);</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.09.24.08H;</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.09.24.09;</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.09.24.10;</text> </paragraph> <paragraph num="(h)"> <text>COMAR 10.09.24.10-1; and</text> </paragraph> <paragraph num="(i)"> <text>COMAR 10.09.24.15A-2(2).</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not considered a countable resource under §E of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant:</text> <paragraph num="(a)"> <text>Child;</text> </paragraph> <paragraph num="(b)"> <text>Parent; or</text> </paragraph> <paragraph num="(c)"> <text>Sibling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Post-Eligibility Determination of Available Income for Optionally Categorically Needy.</text> <paragraph num="(1)"> <text>The countable monthly income considered for the post-eligibility determination is calculated in accordance with rules at §E of this regulation and at COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified at COMAR 10.09.24.07L are not applied.</text> </paragraph> <paragraph num="(2)"> <text>For individuals eligible under §E of this regulation who reside in a residential habitation facility, the Department shall reduce its monthly payment for residential habilitation services by the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order:</text> <paragraph num="(a)"> <text>A personal needs allowance of $170 and the residential habilitation provider's monthly charge of at most $375 to the participant for room and board, as of the effective date of this amendment, either or both of which may be adjusted based on a schedule issued by the Department;</text> </paragraph> <paragraph num="(b)"> <text>A spousal maintenance allowance in accordance with COMAR 10.09.24.10D(2)(b); and</text> </paragraph> <paragraph num="(c)"> <text>Incurred medical expenses as specified at COMAR 10.09.24.10D(2)(d) and (e).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall determine the amount of available income to be paid by a participant towards the cost of care in a residential habilitation facility, based on the countable income remaining after deducting the amounts specified at §F(2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>The residential habilitation provider shall collect the participant's available income, in an amount which may not exceed the cost of residential habilitation services as determined by the Department for the participant.</text> </paragraph> <paragraph num="(5)"> <text>The sum of the participant's cost of care contribution and the Department's payment may not exceed the total cost of residential rehabilitation services as determined by the Department for the participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>All requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider.</text> </paragraph> <paragraph num="(2)"> <text>Requests for payment shall be submitted as set forth in COMAR 10.09.36.04A.</text> </paragraph> <paragraph num="(3)"> <text>Requests for payment shall include all units of service rendered to a waiver participant during the billing period.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing Time Limitations. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made only to a qualified provider. Payment may not be made to a waiver participant, to individual professionals, or to other Program providers in connection with the provision of services specified in Regulations .04—.08-5 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Payments to service coordination providers shall be made according to a monthly waiver participant fee negotiated with the DDA.</text> </paragraph> <paragraph num="(3)"> <text>Payments to residential habilitation service providers or to day habilitation service providers during their first year of operation, to most intensive behavior management providers, to some residential option providers, and to most supported employment providers which are licensed under COMAR 10.22.13 shall be made on a cost-related basis. This includes the following:</text> <paragraph num="(a)"> <text>The Department shall pay these providers an interim payment based on allowable costs included in the human services agreement between DDA and the provider. The final cost settlement shall be actual allowable cost as determined by the Department through the audit and post-audit settlement process specified in COMAR 10.04.03 and 10.04.04. Tentative cost settlements may be made using unaudited annual reports submitted by providers to the Department.</text> </paragraph> <paragraph num="(b)"> <text>Allowable costs are those costs incurred in the delivery of the covered services delineated in this chapter.</text> </paragraph> <paragraph num="(c)"> <text>Return on equity is not an allowable cost.</text> </paragraph> <paragraph num="(d)"> <text>A provider fee as specified in COMAR 10.09.41 is an allowable cost.</text> </paragraph> <paragraph num="(e)"> <text>Room and board is an allowable cost only for respite care provided under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="(f)"> <text>Payments to these providers shall be on a quarterly basis. Providers shall submit quarterly reports of expenditures and requests for payment in the prescribed form to the Division of Program Cost and Analysis of the Maryland Department of Health. Providers shall receive funds in advance of expenditures anticipated in the ensuing quarter of the fiscal year.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Payments to most residential habilitation and day habilitation service providers, some intensive behavior management providers, and some supported employment and residential option providers shall be made according to the prospective payment system specified in COMAR 10.22.17.</text> </paragraph> <paragraph num="(5)"> <text>Payments to medical day care service providers shall be in accordance with COMAR 10.09.07 and the waiver participant's approved plan of care.</text> </paragraph> <paragraph num="(6)"> <text>Notwithstanding any other provision of these regulations, payment may not be made under these regulations for respite care or environmental modifications, as defined in Regulation .01B of this chapter, until the §1915(c) waiver amendment authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made for respite care and environmental modifications retroactive to the effective date of the waiver amendment, but not earlier than April 1, 1991.</text> </paragraph> <paragraph num="(7)"> <text>Notwithstanding any other provision of these regulations, payment may not be made under these regulations for residential option or intensive behavior management services, as defined in Regulation .01B of this chapter, or for services delivered to an individual being discharged or diverted from a chronic care facility, until the waiver amendment under the Social Security Act, Title XIX, §1915(c), authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made retroactive to the effective date of the waiver amendment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Cost Reporting.</text> <paragraph num="(1)"> <text>The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts shall provide at a minimum:</text> <paragraph num="(a)"> <text>Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements.</text> </paragraph> <paragraph num="(b)"> <text>Proper reference to supporting invoices, voucher, or other form of original evidence.</text> </paragraph> <paragraph num="(c)"> <text>Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers.</text> </paragraph> <paragraph num="(d)"> <text>Provision for payment by check. When financial transactions involve numerous small expenditures an imprest petty cash fund shall be established, provided adequate supporting vouchers are maintained.</text> </paragraph> <paragraph num="(e)"> <text>Maintenance of records of all assets.</text> </paragraph> <paragraph num="(f)"> <text>Maintenance of records on a cash or accrual basis.</text> </paragraph> <paragraph num="(g)"> <text>Maintenance of records as required by the Department.</text> </paragraph> <paragraph num="(h)"> <text>Maintenance of all records concerning financial expense and income allocations shall be sufficiently documented by supporting data. Generally accepted accounting principles and the allocation principles of cost accounting theory shall be used for allocation of costs and income.</text> </paragraph> <paragraph num="(i)"> <text>Maintenance of separate records of financial expense and income allocation applicable to:</text> <paragraph num="(i)"> <text>Room and board;</text> </paragraph> <paragraph num="(ii)"> <text>Covered services as specified in Regulations .05—.08-4 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Records shall be maintained for 6 years after the period the cost report to which the materials apply is filed with the Department.</text> </paragraph> <paragraph num="(3)"> <text>The provider shall:</text> <paragraph num="(a)"> <text>Report direct and indirect costs applicable to recipient care. These reports shall clearly identify those direct and indirect costs and income applicable to:</text> <paragraph num="(i)"> <text>Room and board;</text> </paragraph> <paragraph num="(ii)"> <text>Covered services as specified in Regulations .05—.08-4 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Submit to the Division of Program Cost and Analysis of the Department a year-end reconciliation report of financial data in the prescribed form within 30 days of the end of the fiscal year unless the Department grants the provider an extension.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Application of Recipient Income to Cost of Care.</text> <paragraph num="(1)"> <text>The Department of Human Services shall determine the application of Optional Categorically Needy recipient's income toward the cost of services specified in Regulations .05 and .08 of this chapter pursuant to Regulation .12B of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The residential habilitation services provider shall collect the Optional Categorically Needy recipient's available income as certified by the Department of Human Services.</text> </paragraph> <paragraph num="(3)"> <text>The total of an Optional Categorically Needy recipient's available income to be applied to the cost of care and the Department's payment may not exceed the total cost of services specified in Regulations .05 and .08 of this chapter for that individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Appeal Procedures."> <paragraph num="A."> <text>Appeal procedures for providers are as specified in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>Persons filing appeals contending that they were not informed of their choice of services or that they were denied the service of their choice may file an appeal requesting a fair hearing under provisions contained in 42 CFR Part 431, Subpart E.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as specified in COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective February 13, 1984 (11:5 Md. R. 455); emergency status extended at 11:7 Md. R. 621; adopted permanently effective August 12, 1984 (11:15 Md. R. 1330)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 20, 1989 (16:3 Md. R. 343)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective April 1, 1990 (17:8 Md. R. 969); amended permanently effective July 30, 1990 (17:14 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03A, .09B, .11B amended as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 444 (February 22, 1991); amended permanently effective February 18, 1991 (18:3 Md. R. 305)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 6, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03, .05—.11, and .13 amended and .08-1—.08-4 adopted as an emergency provision effective June 8, 1992 (19:12 Md. R. 1130); emergency status extended at 19:19 Md. R. 1702; adopted permanently effective September 28, 1992 (19:19 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .04—.08-3, .09—.11, and .13 amended effective February 28, 1994 (21:4 Md. R. 277)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02, .06, .08-2, .09, and .13 amended as an emergency provision effective November 4, 1992 (19:24 Md. R. 2124); amended permanently effective February 15, 1993 (20:3 Md. R. 258)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05J amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-5 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed and new Regulation .12 adopted effective February 17, 2003 (30:3 Md. R. 179)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> </annotations> </chapter> <chapter num="27" heading="Home Care for Disabled Children Under a Model Waiver"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certified nursing assistant” means an individual who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing; and</text> </paragraph> <paragraph num="(b)"> <text>Performs nursing tasks delegated by a registered nurse or licensed practical nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(3)"> <text>“Disabled child” means a chronically ill or severely impaired child, younger than 22 years old, whose illness or disability may not require 24-hour inpatient care, but which, in the absence of home care services, may precipitate admission to or prolong stay in a hospital, nursing facility, or other long term care facility.</text> </paragraph> <paragraph num="(4)"> <text>“Face-to-face” means contact with a participant that occurs in-person or via audio-visual telehealth in accordance with COMAR 10.09.49.</text> </paragraph> <paragraph num="(5)"> <text>“Home care” means a comprehensive package of medical and health-related services provided under the Program, pursuant to the authority of a model waiver for certain disabled children, as an alternative to institutionalization.</text> </paragraph> <paragraph num="(6)"> <text>“Home care case management” means locating, coordinating, and monitoring home care services for disabled children and includes:</text> <paragraph num="(a)"> <text>Screening of referrals and identification of individuals requiring home care services;</text> </paragraph> <paragraph num="(b)"> <text>Completing a comprehensive assessment to determine the appropriateness of home care services;</text> </paragraph> <paragraph num="(c)"> <text>Convening the multidisciplinary team and coordinating the development of a comprehensive plan of care;</text> </paragraph> <paragraph num="(d)"> <text>Determining individual case cost effectiveness;</text> </paragraph> <paragraph num="(e)"> <text>Identifying and maximizing informal sources of care;</text> </paragraph> <paragraph num="(f)"> <text>Ongoing monitoring of the delivery of services specified in the plan of care to determine the appropriateness of the type, amount, and duration of services rendered;</text> </paragraph> <paragraph num="(g)"> <text>Completing the semiannual utilization review procedure specified in Regulation .03B(1)(c)(ii) of this chapter; and</text> </paragraph> <paragraph num="(h)"> <text>Providing in-home assessments as specified in Regulation .04A(2)(e) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Home care case manager” means the agency administering a program of services for disabled children authorized under Title V of the Social Security Act, or the agency's designee, which provides or arranges for the provision of home care case management services for participants, develops training and community education programs, and establishes standards and procedures for quality assurance and monitoring.</text> </paragraph> <paragraph num="(8)"> <text>“Home care provider” means the principal physician or the individual or agency providing nursing, home health aide services, medical supplies and equipment, or home care case management services to disabled children.</text> </paragraph> <paragraph num="(9)"> <text>“Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10.</text> </paragraph> <paragraph num="(10)"> <text>“Home health aide” means an individual who meets all the conditions of participation specified in:</text> <paragraph num="(a)"> <text>42 CFR §484.36; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(12)"> <text>“Medical day care” has the meaning stated in COMAR 10.09.07.</text> </paragraph> <paragraph num="(13)"> <text>“Medical day care center” has the meaning stated in COMAR 10.09.07.</text> </paragraph> <paragraph num="(14)"> <text>“Medicare” means Medicare as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(15)"> <text>“Model Waiver” means the document and any amendments to it submitted by the Department to, and approved by, the Department of Health and Human Services which authorize the waiver of certain statutory requirements limiting eligibility and covered services under the Medicaid State plan pursuant to §1915(c) of the Social Security Act.</text> </paragraph> <paragraph num="(16)"> <text>“Multidisciplinary team” means the group consisting of the participant or the participant's legal representative or representatives, or all of these, home care providers, and the participant's principal physician or the physician designated by the principal physician, and other providers of health-related services, as appropriate, that establishes and updates the plan of care under the overall direction and coordination of the home care case manager and assesses the appropriateness of the participant's discharge to or continuation of home care.</text> </paragraph> <paragraph num="(17)"> <text>“Necessary” means necessary as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(18)"> <text>“Nurse” means a person who is licensed as a registered nurse or licensed practical nurse in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(19)"> <text>“Nursing care plan” means a plan developed by a registered nurse that identifies:</text> <paragraph num="(a)"> <text>The patient's diagnoses and needs;</text> </paragraph> <paragraph num="(b)"> <text>The goals to be achieved; and</text> </paragraph> <paragraph num="(c)"> <text>The interventions required to meet the patient's medical condition.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Participant” means a recipient:</text> <paragraph num="(a)"> <text>Whose initial eligibility for services under this chapter is established as a disabled child certified by the Department or its designee as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11, or inpatient hospital care pursuant to COMAR 10.09.92—10.09.95, but whose medical condition does not require 24-hour inpatient care unless home care services are not available;</text> </paragraph> <paragraph num="(b)"> <text>Who, once eligibility is established, remains eligible for services under this chapter as long as he or she continues to meet the certification and care requirements of §B(15)(a) of this regulation, regardless of age;</text> </paragraph> <paragraph num="(c)"> <text>Who, but for the services listed in Regulation .04 of this chapter, requires and would be receiving institutional care reimbursed under the Program;</text> </paragraph> <paragraph num="(d)"> <text>Who, before receipt of services under this chapter, was:</text> <paragraph num="(i)"> <text>A patient in a hospital, nursing facility, or other long-term care facility; or</text> </paragraph> <paragraph num="(ii)"> <text>Formerly a patient in a hospital, nursing facility, or other long-term facility who, upon discharge, has continuously received other insurance reimbursement for skilled nursing or home health aide services which has precluded the need for admission to the waiver;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Whose disabilities and needs for home care cannot be adequately and appropriately addressed through provider services otherwise available under the Program; and</text> </paragraph> <paragraph num="(f)"> <text>Who meets the eligibility requirements of these regulations or was receiving services under this chapter as of December 1, 1988 or under COMAR 10.09.31 as of December 31, 1990 and continues to meet the certification and care requirements specified in this chapter.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Plan of care” means the written home care plan which is:</text> <paragraph num="(a)"> <text>Composed of a comprehensive assessment of the participant's health status including:</text> <paragraph num="(i)"> <text>All pertinent diagnoses;</text> </paragraph> <paragraph num="(ii)"> <text>Prognosis;</text> </paragraph> <paragraph num="(iii)"> <text>Functional status;</text> </paragraph> <paragraph num="(iv)"> <text>Level of activity permitted;</text> </paragraph> <paragraph num="(v)"> <text>Type, frequency, and duration of services required;</text> </paragraph> <paragraph num="(vi)"> <text>Treatment goals for each type of service;</text> </paragraph> <paragraph num="(vii)"> <text>Medications; and</text> </paragraph> <paragraph num="(viii)"> <text>Treatments;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Established by the multidisciplinary team;</text> </paragraph> <paragraph num="(c)"> <text>Approved, signed, and dated by the participant's principal physician;</text> </paragraph> <paragraph num="(d)"> <text>Approved, signed, and dated by the participant or the participant's legally authorized representative, or both;</text> </paragraph> <paragraph num="(e)"> <text>Approved, signed, and date by the Department; and</text> </paragraph> <paragraph num="(f)"> <text>Revised 90 days after approval of the initial plan of care and semiannually thereafter, unless the home care case manager decides that a different review period is appropriate.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Principal physician” means the specialty physician who is part of the interdisciplinary team and who approves the plan of care for the participant.</text> </paragraph> <paragraph num="(23)"> <text>“Program” means the Program as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(24)"> <text>“Progress note” means a dated written notation by a home care provider which:</text> <paragraph num="(a)"> <text>Summarizes facts about the care given and the patient's responses during a given period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specifically addresses the established goals of treatment;</text> </paragraph> <paragraph num="(c)"> <text>Is consistent with the participant's plan of care;</text> </paragraph> <paragraph num="(d)"> <text>Is written and signed during the course of care; and</text> </paragraph> <paragraph num="(e)"> <text>Is provided to the home care case management agency to become a part of the agency's permanent record for the participant.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Provider” means a provider as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(26)"> <text>“Provider agreement” means a contract between the Department and the provider of home care, specifying the services to be performed, methods of operation, and financial and legal requirements which shall be in force before Program participation.</text> </paragraph> <paragraph num="(27)"> <text>“Recipient” means a recipient as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(28)"> <text>“Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05.</text> </paragraph> <paragraph num="(29)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(30)"> <text>“Specialty physician” means a licensed physician who meets one of the following criteria:</text> <paragraph num="(a)"> <text>Has been declared board certified, or board eligible, by a member board of the American Board of Medical Specialties, and has demonstrated experience in the care of disabled children; or</text> </paragraph> <paragraph num="(b)"> <text>Has been declared board certified, or board eligible, by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association, and has demonstrated experience in the care of disabled children.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Supervision” means:</text> <paragraph num="(a)"> <text>Authoritative procedural guidance by a licensed registered nurse for the accomplishment of a function or activity; and</text> </paragraph> <paragraph num="(b)"> <text>The process of critical watching, directing, and evaluating an individual's performance.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Telehealth” has the meaning stated in COMAR 10.09.49.02.</text> </paragraph> <paragraph num="(33)"> <text>“Waiver enrollment process” means those procedures necessary to establish participant eligibility pursuant to Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(34)"> <text>“Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services, home health aide services, or certified nursing assistant services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <text>Providers shall meet all licensing requirements specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Medical Assistance Program are that providers shall meet all conditions for participation specified in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a provider of home care services are as follows:</text> <paragraph num="(1)"> <text>The home care case management provider shall:</text> <paragraph num="(a)"> <text>Have a written agreement with each participant which includes the following:</text> <paragraph num="(i)"> <text>A description of the types, amount, frequency, and duration of home care services to be provided to the participant as ordered by the principal physician and specified in the approved plan of care;</text> </paragraph> <paragraph num="(ii)"> <text>A statement that the participant or responsible representatives shall have access to the individual plan of care and shall be involved in its development and periodic review;</text> </paragraph> <paragraph num="(iii)"> <text>The name, address, telephone number, and Medical Assistance number of the participant;</text> </paragraph> <paragraph num="(iv)"> <text>The dated signatures of the participant or legally authorized representative, and the provider representative;</text> </paragraph> <paragraph num="(v)"> <text>A statement that utilization of available services and selection among approved enrolled providers is subject to participant choice;</text> </paragraph> <paragraph num="(vi)"> <text>A statement that services will at all times be provided without discrimination with regard to race, color, age, sex, national origin, marital status, or physical or mental handicap.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Be available to participants in-person at least 8 hours a day, 5 days a week with established hours of operation.</text> </paragraph> <paragraph num="(c)"> <text>Have written and implemented formalized policies and procedures developed before participation in the Program concerning the following areas:</text> <paragraph num="(i)"> <text>Medical records for each participant which include at a minimum the application for home care, plan of care, orders for home care services, documentation of nursing observations at least every 30 days, social history, and home care cost worksheets establishing initial participant eligibility and continued eligibility on a quarterly basis;</text> </paragraph> <paragraph num="(ii)"> <text>Utilization review which includes the development of a home care review procedure completed every 6 months for all participants to evaluate the appropriateness of home care, the efficiency, adequacy, and coordination of home care services, with the objective of achieving the least costly yet appropriate delivery of services under the Program.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Convene the multidisciplinary team which:</text> <paragraph num="(i)"> <text>Upon receipt of the principal physician's orders assesses the appropriateness of home care for the participant;</text> </paragraph> <paragraph num="(ii)"> <text>Determines the medical, psychological, social, and functional status of each participant;</text> </paragraph> <paragraph num="(iii)"> <text>Develops an individual plan of care in conjunction with the principal physician's orders;</text> </paragraph> <paragraph num="(iv)"> <text>Coordinates at least one in-person meeting annually, unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(v)"> <text>Unless otherwise excepted in §B(1)(d)(iv) of this regulation, may meet in-person or via telehealth; and</text> </paragraph> <paragraph num="(vi)"> <text>Reviews and updates the individual plan of care in accordance with Regulation .01B(16) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Provide for in-home assessments, via an in-person visit or telehealth, on a quarterly basis or as determined necessary by the principal physician.</text> </paragraph> <paragraph num="(f)"> <text>Conducts at least two in-person visits annually, unless otherwise authorized by the Department.</text> </paragraph> <paragraph num="(g)"> <text>Not be a provider of medical supplies and equipment or nursing services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shift private duty nursing, certified nursing assistant, and home health aide providers shall:</text> <paragraph num="(a)"> <text>Meet all conditions for participation set forth in:</text> <paragraph num="(i)"> <text>COMAR 10.09.53.03; or</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.09.69;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Participate in interdisciplinary team meetings;</text> </paragraph> <paragraph num="(c)"> <text>Ensure timesheets are signed by the individual rendering services;</text> </paragraph> <paragraph num="(d)"> <text>Ensure a nurse, a certified nursing assistant, or a home health aide is not scheduled to work for more than 16 consecutive hours and the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(e)"> <text>Provide for in-home assessments by the principal physician, on a quarterly basis or as determined necessary by the principal physician.</text> </paragraph> <paragraph num="(f)"> <text>Either be a:</text> <paragraph num="(i)"> <text>Residential service agency licensed in accordance with COMAR 10.07.05; or</text> </paragraph> <paragraph num="(ii)"> <text>Home health agency licensed in accordance with COMAR 10.07.10 which meets the conditions of participation specified in 42 CFR §484.36;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Demonstrate the capacity to arrange for the provision of home health aide services in the amount and level required in the participant's plan of care including the establishment of a contingency plan to assure coverage as specified in the plan of care;</text> </paragraph> <paragraph num="(h)"> <text>Demonstrate sufficient specialized training and experience in the care of individuals with disabilities necessary to deliver the level of services required by participants; and</text> </paragraph> <paragraph num="(i)"> <text>Demonstrate, on a continuing basis, the ability to competently carry out services in the plan of care subject to review by the home care case manager or the home care case manager's designee.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medical day care providers shall meet all conditions for participation set forth in COMAR 10.09.07.</text> </paragraph> <paragraph num="(4)"> <text>The provider of home care services shall:</text> <paragraph num="(a)"> <text>Deliver services in-person unless expressly authorized to render services via telehealth; and</text> </paragraph> <paragraph num="(b)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program reimburses for home care services which include the following:</text> <paragraph num="(1)"> <text>Shift nursing services provided by a licensed registered nurse or a licensed practical nurse if:</text> <paragraph num="(a)"> <text>The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a licensed nurse for a shift of 4 or more continuous hours;</text> </paragraph> <paragraph num="(b)"> <text>The services are delivered to the participant in the participant's home or other setting when normal life activities take the participant outside the home;</text> </paragraph> <paragraph num="(c)"> <text>Services are provided to a model waiver participant who is 21 years old or older;</text> </paragraph> <paragraph num="(d)"> <text>Services are rendered in accordance with COMAR 10.09.53;</text> </paragraph> <paragraph num="(e)"> <text>Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>Sufficient documentation concerning the services provided is maintained by the registered nurse or licensed practical nurse, including:</text> <paragraph num="(i)"> <text>Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and</text> </paragraph> <paragraph num="(ii)"> <text>Signed and dated progress notes which are reviewed monthly by the nurse supervisor;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>The nurse is not scheduled to work for more than 16 consecutive hours and is off 8 or more hours before starting another shift;</text> </paragraph> <paragraph num="(h)"> <text>Services are rendered by a licensed registered or practical nurse certified in cardiopulmonary resuscitation and the certification is renewed every 2 years;</text> </paragraph> <paragraph num="(i)"> <text>Services are preauthorized in accordance with the criteria set forth in COMAR 10.09.53.06; and</text> </paragraph> <paragraph num="(j)"> <text>Supervisory visits are conducted at least monthly in the participant's home or another site where the participant is receiving nursing services with a minimum of two visits per year with the primary nurse present;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Home care case management which includes:</text> <paragraph num="(a)"> <text>Arranging, monitoring, and coordinating the health-related services necessary to meet the identified needs of the participant as specified in the participant's plan of care;</text> </paragraph> <paragraph num="(b)"> <text>Establishing, in conjunction with the other members of the multidisciplinary team, the plan of care necessary to deinstitutionalize or maintain, or both of these, the participant at home;</text> </paragraph> <paragraph num="(c)"> <text>Reviewing the plan of care for appropriateness of the level, amount, type, quality, and frequency of services provided as well as monitoring the cost effectiveness of home care for each participant;</text> </paragraph> <paragraph num="(d)"> <text>Arranging for scheduled reviews and approval of the plan of care by the principal physician; and</text> </paragraph> <paragraph num="(e)"> <text>Providing for in-home assessments, via an in-person visit or telehealth as authorized by the Department, on a quarterly basis, or as determined necessary by the principal physician;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participation by the principal physician in the plan of care meetings including:</text> <paragraph num="(a)"> <text>Prescribing home care services; and</text> </paragraph> <paragraph num="(b)"> <text>Approving and signing the plan of care;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Home health aide services which include:</text> <paragraph num="(a)"> <text>The performance of simple procedures as an extension of therapy services;</text> </paragraph> <paragraph num="(b)"> <text>Ambulation and exercise;</text> </paragraph> <paragraph num="(c)"> <text>Household services essential to health care at home;</text> </paragraph> <paragraph num="(d)"> <text>Assistance with medications that are ordinarily self-administered;</text> </paragraph> <paragraph num="(e)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services;</text> </paragraph> <paragraph num="(f)"> <text>Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, if:</text> <paragraph num="(i)"> <text>The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a home health aide for a shift of 4 or more continuous hours;</text> </paragraph> <paragraph num="(ii)"> <text>Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Services are rendered by a home health aide certified in cardiopulmonary resuscitation and the certification is renewed every 2 years;</text> </paragraph> <paragraph num="(iv)"> <text>The home health aide is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift;</text> </paragraph> <paragraph num="(v)"> <text>Sufficient documentation is maintained by the home health aide including verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor;</text> </paragraph> <paragraph num="(vi)"> <text>Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present;</text> </paragraph> <paragraph num="(vii)"> <text>The services are included in the model waiver participant's plan of care developed by the case manager; and</text> </paragraph> <paragraph num="(viii)"> <text>Services are preauthorized by the Department;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Certified nursing assistant services if:</text> <paragraph num="(a)"> <text>The certified nursing assistant is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a certified nursing assistant for a shift of 4 or more continuous hours;</text> </paragraph> <paragraph num="(c)"> <text>The services provided include but are not limited to:</text> <paragraph num="(i)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or</text> </paragraph> <paragraph num="(ii)"> <text>Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Services are rendered by a certified nursing assistant certified in cardiopulmonary resuscitation and the certification is renewed every 2 years;</text> </paragraph> <paragraph num="(e)"> <text>The certified nursing assistant is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift;</text> </paragraph> <paragraph num="(f)"> <text>Sufficient documentation concerning the services provided is maintained by the certified nursing assistant including:</text> <paragraph num="(i)"> <text>Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and</text> </paragraph> <paragraph num="(ii)"> <text>Signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present;</text> </paragraph> <paragraph num="(h)"> <text>The services are included in the model waiver participant's plan of care developed by the case manager; and</text> </paragraph> <paragraph num="(i)"> <text>Services are preauthorized by the Department;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Delegated nursing services provided by a certified nursing assistant or home health aide who is also a certified medical technician when:</text> <paragraph num="(a)"> <text>The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the certified nursing assistant or home health aide for at least 2 or more continuous hours;</text> </paragraph> <paragraph num="(b)"> <text>The services provided include but are not limited to:</text> <paragraph num="(i)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or</text> </paragraph> <paragraph num="(ii)"> <text>Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Sufficient documentation is maintained by the certified nursing assistant or home health aide, including signed and dated progress notes which are reviewed by the nurse supervisor; and</text> </paragraph> <paragraph num="(d)"> <text>Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Medical day care when services are:</text> <paragraph num="(a)"> <text>Included in the Model Waiver participant's approved and signed plan of care; and</text> </paragraph> <paragraph num="(b)"> <text>Rendered in accordance with COMAR 10.09.07.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department will reimburse for the services listed in §A(1)—(2) and (4)—(6) of this regulation when they are:</text> <paragraph num="(1)"> <text>Ordered by the participant's principal physician as part of a written home care plan, which is included in the provider's permanent record for the participant and is reviewed by the principal physician in accordance with Regulation .01B(16) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Adequately described in progress notes in the participant's medical record, signed, and dated by the individual providing care;</text> </paragraph> <paragraph num="(4)"> <text>Provided instead of institutional care to recipients certified and annually recertified as requiring nursing facility care under the Program as specified in COMAR 10.09.10 or 10.09.11; and</text> </paragraph> <paragraph num="(5)"> <text>Provided in the amount, duration, and frequency specified in the plan of care subject to approval by the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Eligibility."> <paragraph num="A."> <text>Requirements. Model waiver participants shall meets the financial eligibility requirements under §B, C, or D of this regulation and the nonfinancial requirements of §§E and F of this regulation.</text> </paragraph> <paragraph num="B."> <text>Categorically needy eligibility recipients of supplemental security income benefits under Title XVI of the Social Security Act are eligible for medical assistance benefits as categorically needy individuals as specified in COMAR 10.09.24.</text> </paragraph> <paragraph num="C."> <text>Optional Categorically Needy Eligibility. Individuals who do not qualify for supplemental security income benefits may apply for eligibility under the provision of this section and applicable sections of COMAR 10.09.24, as follows:</text> <paragraph num="(1)"> <text>COMAR 10.09.24, exclusive of Regulations .06, .08L, .09, and .10, applies for the purpose of determining eligibility as an optional categorically needy individual.</text> </paragraph> <paragraph num="(2)"> <text>An individual is eligible for medical assistance benefits as an optional categorically needy individual if they comply with the requirements of §C(1) of this regulation, including the requirement that resources not exceed the applicable standard for supplemental security income eligibility, and if the income of the individual before the disregards specified in §C(3) of this regulation does not exceed 300 percent of the supplemental security income benefit amount payable under §1611(b)(i) of the Social Security Act to an individual in their own home who has no income or resources.</text> </paragraph> <paragraph num="(3)"> <text>Disregards. The following disregards are subtracted from income computed according to COMAR 10.09.24.07A—K in order to determine the amount of the income of recipients qualifying under this section to be applied toward the cost of services specified in Regulation .04 of this chapter.</text> <paragraph num="(a)"> <text>The amount of the medically needy income standard for one person established under COMAR 10.09.24.07;</text> </paragraph> <paragraph num="(b)"> <text>Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including:</text> <paragraph num="(i)"> <text>Medicare and other health insurance premiums, deductibles, or co-insurance charges, and</text> </paragraph> <paragraph num="(ii)"> <text>Necessary medical or remedial care recognized under State law but not covered under the Program.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Medically Needy Eligibility. Financial eligibility for individuals who do not qualify as categorically needy recipients as specified in §B, or optional categorically needy recipients as specified in §C of this regulation is determined according to provisions of COMAR 10.09.24 relating to determinations of medically needy eligibility.</text> </paragraph> <paragraph num="E."> <text>To be eligible to receive services under the model waiver for disabled children a person shall:</text> <paragraph num="(1)"> <text>Be certified and annually recertified as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11;</text> </paragraph> <paragraph num="(2)"> <text>Be approved by the Department or its designee as appropriate for home care based on a comprehensive assessment of the participant's health status as set forth in Regulation .01B(15) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Choose between institutional or home care services under the Program;</text> </paragraph> <paragraph num="(4)"> <text>Be a recipient:</text> <paragraph num="(a)"> <text>For whom it can reasonably be expected that the cost of home care services would not exceed the cost of the level of care provided in an institution, and</text> </paragraph> <paragraph num="(b)"> <text>Whose plan of care meets the requirement of §F of this regulation relating to cost effective coverage of home care services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Eligibility for coverage of home care services for disabled children is limited to individuals for whom the projected total cost that would be incurred by the Program if the coverage and services specified in this chapter were not available is greater, on an annual basis, than the projected total cost that would be incurred by the Program for the services listed in Regulation .04 of this chapter and all other services available under the Program based on the following formula:</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures as set forth in COMAR 10.09.36 apply.</text> </paragraph> <paragraph num="B."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>Providers shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established according to the fee schedule published by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Rates.</text> <paragraph num="(1)"> <text>The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2022, rates for services governed by this chapter are as follows:</text> <paragraph num="(a)"> <text>For home health aide or certified nursing assistant services provided to one participant:</text> <paragraph num="(i)"> <text>$5.0809 per 15 minutes of services; or</text> </paragraph> <paragraph num="(ii)"> <text>If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.1208 per 15 minutes of services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For home health aide or certified nursing assistant services provided to two or more participants in the same residence:</text> <paragraph num="(i)"> <text>$3.5044 per 15 minutes of services per participant; or</text> </paragraph> <paragraph num="(ii)"> <text>If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.2232 per 15 minutes of service per participant; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Payments for home care case management services shall be made as follows:</text> <paragraph num="(i)"> <text>Waiver enrollment process — $1,181.61;</text> </paragraph> <paragraph num="(ii)"> <text>First month of home care case management — $1,181.61; and</text> </paragraph> <paragraph num="(iii)"> <text>The second and any subsequent month of home care case management — $590.80.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective January 1, 2024 through June 30, 2024, rates for services governed by this chapter are as follows:</text> <paragraph num="(a)"> <text>For home health aide or certified nursing assistant services provided to one participant:</text> <paragraph num="(i)"> <text>$5.4874 per 15 minutes of services; or</text> </paragraph> <paragraph num="(ii)"> <text>$6.6105 per 15 minutes of service if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For home health aide or certified nursing assistant services provided to two or more participants in the same residence:</text> <paragraph num="(i)"> <text>$3.7848 per 15 minutes of services per participant; or</text> </paragraph> <paragraph num="(ii)"> <text>$4.5611 per 15 minutes of service per participant if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Payments for home care case management services shall be made as follows:</text> <paragraph num="(i)"> <text>Waiver enrollment process — $1,276.14;</text> </paragraph> <paragraph num="(ii)"> <text>First month of home care case management — $1,276.14; and</text> </paragraph> <paragraph num="(iii)"> <text>The second and any subsequent month of home care case management — $638.06.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Effective July 1, 2024, rates for services governed by this chapter are as follows:</text> <paragraph num="(a)"> <text>For home health aide or certified nursing assistant services provided to one participant:</text> <paragraph num="(i)"> <text>$5.6520 per 15 minutes of services; or</text> </paragraph> <paragraph num="(ii)"> <text>If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.8088 per 15 minutes of services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For home health aide or certified nursing assistant services provided to two or more participants in the same residence:</text> <paragraph num="(i)"> <text>$3.8983 per 15 minutes of services per participant; or</text> </paragraph> <paragraph num="(ii)"> <text>If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.6979 per 15 minutes of service per participant; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Payments for home care case management services shall be made as follows:</text> <paragraph num="(i)"> <text>Waiver enrollment process — $1,314.42;</text> </paragraph> <paragraph num="(ii)"> <text>First month of home care case management — $1,314.42; and</text> </paragraph> <paragraph num="(iii)"> <text>The second and any subsequent month of home care case management — $657.21.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures shall be as specified in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as specified in COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective May 10, 1985 (12:11 Md. R. 1041); emergency status extended at 12:19 Md. R. 1843 and 13:6 Md. R. 669; adopted permanently effective March 10, 1986 (13:5 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 amended as an emergency provision effective March 11, 1991 (18:7 Md. R. 765); amended permanently effective July 1, 1991 (18:12 Md. R. 1339)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A—C amended effective July 1, 1989 (16:12 Md. R. 1336)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective August 25, 1986 (13:17 Md. R. 1922)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective August 25, 1986 (13:17 Md. R. 1922)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 1991 (18:12 Md. R. 1339)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 17, 2006 (33:14 Md. R. 1163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077); September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective July 17, 2006 (33:14 Md. R. 1163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 17, 2006 (33:14 Md. R. 1163); August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective August 21, 2023 (50:16 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective July 17, 2006 (33:14 Md. R. 1163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1346); amended permanently effective October 8, 2007 (34:20 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective April 6, 2009 (36:7 Md. R. 523); February 8, 2010 (37:3 Md. R. 175); August 21, 2023 (50:16 Md. R. 725); November 24, 2025 (52:23 Md. R. 1139)</annotation> </annotations> </chapter> <chapter num="28" heading="Applied Behavior Analysis Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Applied Behavior Analysis (ABA).</text> <paragraph num="(a)"> <text>“Applied behavior analysis (ABA)” means the design, implementation, and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvements in human behavior.</text> </paragraph> <paragraph num="(b)"> <text>“Applied behavior analysis (ABA)” includes the direct observations, measurement, and functional analysis of the relations between environment and behavior.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“ABA program” means an association, partnership, corporation, or unincorporated group that includes:</text> <paragraph num="(a)"> <text>A licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>A BCaBA, RBT, or a BT.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Autism spectrum disorder (ASD)” means a group of developmental disorders:</text> <paragraph num="(a)"> <text>Characterized by persistent deficits in social communication and social interaction across multiple contexts;</text> </paragraph> <paragraph num="(b)"> <text>Characterized by restricted, repetitive patterns of behavior, interests, or activities; and</text> </paragraph> <paragraph num="(c)"> <text>Whose symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Behavior Analyst Certification Board (BACB)” means the Board accredited by the National Commission for Certifying Agencies that credentials and certifies an LBA or BCaBA, or registers an RBT.</text> </paragraph> <paragraph num="(5)"> <text>“Behavior technician (BT)” means a paraprofessional in the process of obtaining BACB certification who delivers ABA services that are provided to participants with ASD under the supervision of a licensed:</text> <paragraph num="(a)"> <text>Psychologist;</text> </paragraph> <paragraph num="(b)"> <text>BCBA-D; or</text> </paragraph> <paragraph num="(c)"> <text>BCBA.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Board certified assistant behavior analyst (BCaBA)” means a paraprofessional who:</text> <paragraph num="(a)"> <text>Delivers ABA treatments that are provided to participants with ASD under the supervision of:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Obtained a BACB certification.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Board certified behavior analyst (BCBA)” means a licensed professional who:</text> <paragraph num="(a)"> <text>Renders and provides direction for ABA services that are provided to participants with ASD; and</text> </paragraph> <paragraph num="(b)"> <text>Obtained a BACB certification.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Board certified behavior analyst-doctoral (BCBA-D)” means a licensed professional who:</text> <paragraph num="(a)"> <text>Renders and provides direction for ABA treatments that are provided to participants with ASD; and</text> </paragraph> <paragraph num="(b)"> <text>Obtained a BACB certification with a doctoral-level credential.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Caregiver” means a willing and able individual who is trained in providing care to the participant.</text> </paragraph> <paragraph num="(10)"> <text>“Comprehensive diagnostic evaluation” means an assessment performed by a qualified health care professional with the help of validated instruments, which includes:</text> <paragraph num="(a)"> <text>A direct observation of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Interviews with the participant’s parent or caregiver;</text> </paragraph> <paragraph num="(c)"> <text>Documentation of developmental history, psychosocial history, and current functioning across major domains of development; and</text> </paragraph> <paragraph num="(d)"> <text>A confirmed diagnosis of Autism Spectrum Disorder (ASD).</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Custodial care” means care that is provided:</text> <paragraph num="(a)"> <text>To assist in the activities of daily living, such as bathing, dressing, eating, and maintaining personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>For maintaining the participant's safety; and</text> </paragraph> <paragraph num="(c)"> <text>By individuals without professional skills or training.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(13)"> <text>“Designee” means the entity designated by the Department to manage the public behavioral health system on behalf of the Department.</text> </paragraph> <paragraph num="(14)"> <text>“Direction of a technician” means the in-person monitoring of a BCaBA, RBT, or BT, performed by a licensed psychologist or an LBA.</text> </paragraph> <paragraph num="(15)"> <text>“Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services.</text> </paragraph> <paragraph num="(16)"> <text>“Family” means an adult who:</text> <paragraph num="(a)"> <text>Lives with or provides care to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Is not paid to provide the care.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“HIPAA” means the Health Insurance Portability and Accountability Act, a federal law enacted on August 21, 1996, whose purpose is to improve the efficiency and effectiveness of the health care system by standardizing the electronic exchange of administrative and financial data, provide security requirements for transmitted information, and protect the privacy of identifiable health information.</text> </paragraph> <paragraph num="(18)"> <text>“Individualized education program (IEP)” means a written description of special education and related services to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09.</text> </paragraph> <paragraph num="(19)"> <text>“Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(20)"> <text>“Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions.</text> </paragraph> <paragraph num="(21)"> <text>“Licensed behavior analyst (LBA)” means a licensed professional who is certified by the Behavior Analyst Certification Board (BACB) to be a:</text> <paragraph num="(a)"> <text>BCBA; or</text> </paragraph> <paragraph num="(b)"> <text>BCBA-D.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Maladaptive Behavior.</text> <paragraph num="(a)"> <text>“Maladaptive behavior” means behavior that interferes with the participant's activities of daily living or ability to adjust or participate in particular settings.</text> </paragraph> <paragraph num="(b)"> <text>“Maladaptive behavior” includes behaviors such as self-injurious behavior, aggression, tantrums, stereotypies, and rituals.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Maryland Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended.</text> </paragraph> <paragraph num="(24)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., as amended.</text> </paragraph> <paragraph num="(26)"> <text>“Parent” means the adult representative of a participant and includes:</text> <paragraph num="(a)"> <text>A biological or adoptive parent;</text> </paragraph> <paragraph num="(b)"> <text>A legal guardian;</text> </paragraph> <paragraph num="(c)"> <text>An individual acting in the place of a parent, such as a grandparent or stepparent with whom the participant lives, including those relatives or stepparents who are foster parents;</text> </paragraph> <paragraph num="(d)"> <text>An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act; or</text> </paragraph> <paragraph num="(e)"> <text>Another individual responsible for a participant's welfare.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Participant” means an eligible individual who is enrolled in the Program.</text> </paragraph> <paragraph num="(28)"> <text>“Plan for generalization” means a component of the treatment plan whose goal is the expansion of a participant's performance ability beyond the initial conditions set for acquisition of a skill that can occur across people, places, and materials used for teaching.</text> </paragraph> <paragraph num="(29)"> <text>“Preauthorized” means the approval required from the Department, or its designee, before a provider renders services in order to receive reimbursement for services.</text> </paragraph> <paragraph num="(30)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(31)"> <text>“Provider” means a person certified to provide ABA services to participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(32)"> <text>“Psychologist” means an individual who is:</text> <paragraph num="(a)"> <text>Licensed and legally authorized to practice psychology under Health Occupations Article, Title 18, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed and legally authorized to practice psychology in the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Qualified health care professional” means a developmental pediatrician, pediatrician, pediatric neurologist, child psychiatrist, clinical psychologist, neuropsychologist, or a nurse practitioner with training and experience to diagnose ASD.</text> </paragraph> <paragraph num="(34)"> <text>“Registered behavior technician (RBT)” means a paraprofessional certified by the BACB who delivers ABA services that are provided to participants with ASD under the supervision of:</text> <paragraph num="(a)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(b)"> <text>An LBA.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Remote access technology” means the use of HIPAA compliant technological methods to provide auditory and visual connection between a licensed psychologist or an LBA, who is not directly present, and a BCaBA, RBT, or BT when services are being provided at the participant’s home.</text> </paragraph> <paragraph num="(36)"> <text>“Remote direction of a technician” means the monitoring of a BCaBA, RBT, or BT, who is physically with the participant, performed via synchronous two-way audio-visual remote access technology by a licensed psychologist or an LBA.</text> </paragraph> <paragraph num="(37)"> <text>“Treatment plan” means an individualized written plan for ABA services which includes the components specified in Regulation .03 of this chapter..</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Provider Qualifications and Conditions for Participation."> <paragraph num="A."> <text>To participate in the Program, a provider shall:</text> <paragraph num="(1)"> <text>Meet all conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An ABA provider shall be licensed, certified, or otherwise legally authorized to provide ABA services in the jurisdiction in which the services are provided.</text> </paragraph> <paragraph num="C."> <text>An ABA provider may not have current sanctions or current disciplinary actions imposed by:</text> <paragraph num="(1)"> <text>The jurisdictional licensing or certification authority;</text> </paragraph> <paragraph num="(2)"> <text>Medicare Program;</text> </paragraph> <paragraph num="(3)"> <text>Maryland Medical Assistance Program; or</text> </paragraph> <paragraph num="(4)"> <text>Other federally funded healthcare program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An ABA provider shall have a completed Criminal Justice Information System's criminal background check.</text> </paragraph> <paragraph num="E."> <text>A licensed psychologist who renders ABA services shall:</text> <paragraph num="(1)"> <text>Be licensed by the Maryland Board of Examiners of Psychologists; and</text> </paragraph> <paragraph num="(2)"> <text>Act within the licensee's scope of practice.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A BCBA-D provider who renders ABA services shall:</text> <paragraph num="(1)"> <text>Be licensed by the Maryland Board of Professional Counselors and Therapists; and</text> </paragraph> <paragraph num="(2)"> <text>Have a current certification of BCBA-D by the BACB.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A BCBA provider who renders ABA services shall:</text> <paragraph num="(1)"> <text>Be licensed by the Maryland Board of Professional Counselors and Therapists; and</text> </paragraph> <paragraph num="(2)"> <text>Have a current certification of BCBA by the BACB.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A BCaBA provider who renders ABA services shall:</text> <paragraph num="(1)"> <text>Have a current certification of BCaBA by the BACB;</text> </paragraph> <paragraph num="(2)"> <text>Work under the direction of:</text> <paragraph num="(a)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(b)"> <text>An LBA; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have the supervisory relationship documented in writing.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An RBT provider who renders ABA services shall:</text> <paragraph num="(1)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Be currently registered by the BACB;</text> </paragraph> <paragraph num="(3)"> <text>Have a high school degree or national equivalent;</text> </paragraph> <paragraph num="(4)"> <text>Work under the direction of:</text> <paragraph num="(a)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(b)"> <text>An LBA; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have the supervisory relationship documented in writing.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A BT provider who renders ABA services shall:</text> <paragraph num="(1)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Obtain BACB registration within 90 days of enrollment with Maryland Medicaid;</text> </paragraph> <paragraph num="(3)"> <text>Have a high school degree or national equivalent;</text> </paragraph> <paragraph num="(4)"> <text>Work under the direction of:</text> <paragraph num="(a)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(b)"> <text>An LBA; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have the supervisory relationship documented in writing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>A participant shall meet the eligibility conditions set forth in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>To qualify for ABA services, a participant shall:</text> <paragraph num="(1)"> <text>Be younger than 21 years old;</text> </paragraph> <paragraph num="(2)"> <text>Live in the community;</text> </paragraph> <paragraph num="(3)"> <text>Be diagnosed with an ASD by a qualified health care professional;</text> </paragraph> <paragraph num="(4)"> <text>Exhibit the presence of maladaptive behavior or developmental skills deficits that significantly interferes with home, school, or community activities;</text> </paragraph> <paragraph num="(5)"> <text>Be medically stable and not require 24-hour medical or nursing monitoring or procedures provided in a hospital or an ICF-IID;</text> </paragraph> <paragraph num="(6)"> <text>Have a comprehensive diagnostic evaluation by a qualified health care professional;</text> </paragraph> <paragraph num="(7)"> <text>Be referred for ABA services by a licensed health care professional; and</text> </paragraph> <paragraph num="(8)"> <text>Have a completed ABA treatment plan that shall:</text> <paragraph num="(a)"> <text>Be participant-centered and family-centered, culturally competent, and based on individualized goals;</text> </paragraph> <paragraph num="(b)"> <text>Consider the participant's age, school attendance requirements, and other daily activities;</text> </paragraph> <paragraph num="(c)"> <text>Be developed by:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Ensure that the interventions are consistent with ABA techniques;</text> </paragraph> <paragraph num="(e)"> <text>Delineate both the frequency of baseline targeted behaviors and the behavior intervention plan to address the behaviors;</text> </paragraph> <paragraph num="(f)"> <text>Identify long-term goals, short-term goals, and objectives that:</text> <paragraph num="(i)"> <text>Are behaviorally defined;</text> </paragraph> <paragraph num="(ii)"> <text>Are customized to the participant;</text> </paragraph> <paragraph num="(iii)"> <text>Are measurable; and</text> </paragraph> <paragraph num="(iv)"> <text>Are based upon clinical observations;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Identify the methods that will be used to measure achievement of behavior goals, objectives, and estimated timeframes;</text> </paragraph> <paragraph num="(h)"> <text>Identify the schedule of services planned, including number of hours per week and the providers responsible for delivering the services;</text> </paragraph> <paragraph num="(i)"> <text>Include:</text> <paragraph num="(i)"> <text>Care coordination involving the participant's parent or caregiver and other professionals as applicable;</text> </paragraph> <paragraph num="(ii)"> <text>Support and training of the participant's parent or caregiver;</text> </paragraph> <paragraph num="(iii)"> <text>A plan for generalization; and</text> </paragraph> <paragraph num="(iv)"> <text>Measurable discharge criteria.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the ABA services set forth in §B of this regulation when the services are:</text> <paragraph num="(1)"> <text>Medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Preauthorized by the Program or its designee;</text> </paragraph> <paragraph num="(3)"> <text>Delivered in accordance with the participant's treatment plan; and</text> </paragraph> <paragraph num="(4)"> <text>Supported by documentation of consent to treatment from the participant or the participant’s parent or guardian.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers the following ABA services:</text> <paragraph num="(1)"> <text>An ABA assessment, which is a behavior identification assessment that:</text> <paragraph num="(a)"> <text>Is administered in person with a participant and the participant's parent or caregiver by:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Addresses the behavioral needs for ABA services; and</text> </paragraph> <paragraph num="(c)"> <text>Includes:</text> <paragraph num="(i)"> <text>An interview, direct observation, record review, data collection, and analysis;</text> </paragraph> <paragraph num="(ii)"> <text>An assessment of the participant's current level of functioning, skills deficits, and maladaptive behaviors using validated instruments;</text> </paragraph> <paragraph num="(iii)"> <text>Analysis of past data;</text> </paragraph> <paragraph num="(iv)"> <text>Scoring and interpreting the assessment;</text> </paragraph> <paragraph num="(v)"> <text>Preparing the treatment plan and report; and</text> </paragraph> <paragraph num="(vi)"> <text>Discussion of the findings;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A behavior identification supporting assessment which is a follow-up assessment that is administered:</text> <paragraph num="(a)"> <text>In person, by an RBT, BT, or BCaBA, with a participant present; and</text> </paragraph> <paragraph num="(b)"> <text>Under the direction of a licensed psychologist or an LBA;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An exposure behavior identification supporting assessment which is a follow-up assessment that:</text> <paragraph num="(a)"> <text>Is conducted on a participant with specific, severe destructive behaviors in a structured, safe environment;</text> </paragraph> <paragraph num="(b)"> <text>Is administered in person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs;</text> </paragraph> <paragraph num="(c)"> <text>Exposes the participant to a customized series of social and environmental conditions associated with the destructive behaviors; and</text> </paragraph> <paragraph num="(d)"> <text>Uses structured testing to examine events, cues, responses, and consequences associated with the behaviors;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An adaptive behavior treatment with protocol modification which is an in-person service that:</text> <paragraph num="(a)"> <text>Is conducted on a participant with specific, severe destructive behaviors in an environment that is:</text> <paragraph num="(i)"> <text>Customized;</text> </paragraph> <paragraph num="(ii)"> <text>Structured; and</text> </paragraph> <paragraph num="(iii)"> <text>Safe;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is administered in-person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs;</text> </paragraph> <paragraph num="(c)"> <text>Includes in-person direction of two or more technicians eliciting behavioral effects or exposing the participant to specific environmental conditions and treatment; and</text> </paragraph> <paragraph num="(d)"> <text>Refines and modifies ineffective components of the treatment;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Group adaptive behavior treatment by protocol which is an in-person service provided to a group of two or more participants by:</text> <paragraph num="(a)"> <text>A licensed psychologist;</text> </paragraph> <paragraph num="(b)"> <text>An LBA; or</text> </paragraph> <paragraph num="(c)"> <text>A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention protocol designed in advance by the psychologist or an LBA who may or may not provide in-person direction of a technician during the treatment;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Multiple-family group adaptive behavior treatment guidance that:</text> <paragraph num="(a)"> <text>Is provided in person with parents or caregivers of multiple participants without the presence of the participants by:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Identifies maladaptive behaviors and skills deficits;</text> </paragraph> <paragraph num="(c)"> <text>Instructs parents or caregivers on how to utilize ABA treatments to reduce maladaptive behaviors and skill deficits; and</text> </paragraph> <paragraph num="(d)"> <text>Is performed in person for at least 25 percent of the session time each month;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Family adaptive behavior treatment guidance which:</text> <paragraph num="(a)"> <text>Is provided in person or remotely with a participant’s parent or caregiver, with or without the presence of the participant by:</text> <paragraph num="(i)"> <text>A licensed psychologist;</text> </paragraph> <paragraph num="(ii)"> <text>An LBA; or</text> </paragraph> <paragraph num="(iii)"> <text>A BCaBA;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Identifies maladaptive behaviors and skills deficits;</text> </paragraph> <paragraph num="(c)"> <text>Instructs the parent or caregiver on how to utilize ABA strategies to reduce maladaptive behaviors and skill deficits; and</text> </paragraph> <paragraph num="(d)"> <text>Is performed in person for at least 25 percent of the session time each month;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A behavior identification reassessment which is a follow-up assessment that:</text> <paragraph num="(a)"> <text>Is performed in person with a participant and a participant's parent or caregiver every 180 days by:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evaluates the progress toward each behavior treatment goal using objective, quantifiable measures and includes the results of validated instruments;</text> </paragraph> <paragraph num="(c)"> <text>Includes a revision of the treatment plan based on progress; and</text> </paragraph> <paragraph num="(d)"> <text>Includes a clinical recommendation as to whether ABA services continue to be medically necessary;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Group adaptive behavior treatment with protocol modification which is a service that is:</text> <paragraph num="(a)"> <text>Provided in person to multiple participants by:</text> <paragraph num="(i)"> <text>A licensed psychologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An LBA;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Focused on social skills training; and</text> </paragraph> <paragraph num="(c)"> <text>Aimed at identifying and targeting individual participants social deficits and maladaptive behaviors;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Adaptive behavior treatment direction of a technician which is the clinical direction and oversight of a BCaBA, RBT, or a BT by a licensed psychologist or an LBA that:</text> <paragraph num="(a)"> <text>Requires the licensed psychologist or the LBA to directly or remotely observe the BCaBA, RBT, or BT administering ABA services to the participant, group of participants, parent, or caregiver;</text> </paragraph> <paragraph num="(b)"> <text>Is performed on an ongoing basis, equal to at least 10 percent of the amount of hours that the BCaBA, RBT, or BT is providing direct ABA services to the participant, or group of participants; and</text> </paragraph> <paragraph num="(c)"> <text>Is performed in person for at least 25 percent of the session time each month;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Adaptive behavior treatment by protocol which is an in-person service provided to a participant by:</text> <paragraph num="(a)"> <text>A licensed psychologist or an LBA; or</text> </paragraph> <paragraph num="(b)"> <text>A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention designed in advance by the licensed psychologist or an LBA, who may or may not provide in-person or remote direction during the treatment; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Adaptive behavior treatment planning which is an ongoing indirect service that:</text> <paragraph num="(a)"> <text>Is performed by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>Includes:</text> <paragraph num="(i)"> <text>Development and revision of the treatment plan and goals;</text> </paragraph> <paragraph num="(ii)"> <text>Data analysis; and</text> </paragraph> <paragraph num="(iii)"> <text>Real-time, direct communication and coordination with the participant's other service providers.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>ABA services shall only be provided by a licensed psychologist, LBA, BCaBA, RBT, or BT.</text> </paragraph> <paragraph num="D."> <text>ABA services shall be initially preauthorized for a period not to exceed 180 days.</text> </paragraph> <paragraph num="E."> <text>Additional preauthorization beyond the initial preauthorization shall be requested every 180 days, in advance of the expiration of the previous preauthorization.</text> </paragraph> <paragraph num="F."> <text>The provider shall maintain documentation of each service delivered under the participant's treatment plan, which, at a minimum, includes:</text> <paragraph num="(1)"> <text>The location, date, start time, and end time of the service;</text> </paragraph> <paragraph num="(2)"> <text>A brief description of the service provided, including reference to the treatment plan;</text> </paragraph> <paragraph num="(3)"> <text>A description of the participant's behaviors or symptoms in measurable terms;</text> </paragraph> <paragraph num="(4)"> <text>A description of the participant’s parent or caregiver’s participation in the ABA treatment sessions, including the parent or the caregiver’s name and relationship to the participant, date, and time of participation or notification of the participant’s parent or caregiver’s consent to be absent; and</text> </paragraph> <paragraph num="(5)"> <text>A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>ABA services are only available to participants under the EPSDT program.</text> </paragraph> <paragraph num="B."> <text>ABA services shall be delivered in a home or community setting, including a clinic, when medically necessary.</text> </paragraph> <paragraph num="C."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Services that are:</text> <paragraph num="(a)"> <text>Provided in:</text> <paragraph num="(i)"> <text>A hospital;</text> </paragraph> <paragraph num="(ii)"> <text>An institution for mental disease;</text> </paragraph> <paragraph num="(iii)"> <text>An ICF-IID;</text> </paragraph> <paragraph num="(iv)"> <text>A crisis residential program;</text> </paragraph> <paragraph num="(v)"> <text>A residential treatment center;</text> </paragraph> <paragraph num="(vi)"> <text>A 24-hour, 365-day residential program funded with federal, State, or local government funds; or</text> </paragraph> <paragraph num="(vii)"> <text>Nonconventional settings, including but not limited to resorts, spas, and camps;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Rendered when measurable functional improvement or continued clinical benefit is not met, and treatment is not deemed necessary;</text> </paragraph> <paragraph num="(c)"> <text>Not preauthorized by the Department or its designee;</text> </paragraph> <paragraph num="(d)"> <text>Beyond the provider's scope of practice;</text> </paragraph> <paragraph num="(e)"> <text>Rendered but not documented in accordance to Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Rendered by mail or telephone;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services whose purpose is vocationally based or recreationally based;</text> </paragraph> <paragraph num="(3)"> <text>Respite services;</text> </paragraph> <paragraph num="(4)"> <text>Custodial care;</text> </paragraph> <paragraph num="(5)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(6)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(7)"> <text>Travel to and from site of service; and</text> </paragraph> <paragraph num="(8)"> <text>Services which duplicate a service that a participant is receiving under another medical care program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The participant’s parent or caregiver shall be trained to reinforce ABA services for the participant in a clinically effective manner.</text> </paragraph> <paragraph num="E."> <text>Services shall be discontinued if no longer medically necessary because:</text> <paragraph num="(1)"> <text>Long-term treatment goals and objectives are achieved; or</text> </paragraph> <paragraph num="(2)"> <text>Participant is not demonstrating progress towards treatment goals and objectives and measurable functional improvement is no longer expected.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The provider shall obtain approval by the Department or its designee for remote supervision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall follow all procedures in accordance with COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>The Program shall provide fee-for-service reimbursement for covered ABA services to the following ABA providers who meet the conditions for participation set forth in Regulation .02 of this chapter:</text> <paragraph num="(1)"> <text>ABA program;</text> </paragraph> <paragraph num="(2)"> <text>Individual licensed psychologist; and</text> </paragraph> <paragraph num="(3)"> <text>Individual LBA.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursement for ABA services may not be made directly to a BCaBA, RBT, or BT rendering ABA services.</text> </paragraph> <paragraph num="D."> <text>Reimbursement for ABA services may not be made to, or on behalf of services rendered by, the participant's parent or caregiver.</text> </paragraph> <paragraph num="E."> <text>The Program shall pay for covered services:</text> <paragraph num="(1)"> <text>At the lesser of the provider's customary charge to the general public unless the services are free to the individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>In accordance with COMAR 10.09.36.06.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Effective July 1, 2022 through June 30, 2023, reimbursement for ABA services covered under this chapter is as follows:</text> <paragraph num="(1)"> <text>Behavior identification assessment at a rate of $33.46 per 15 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Behavior identification assessment follow-up at a rate of $16.73 per 15 minutes;</text> </paragraph> <paragraph num="(3)"> <text>Exposure behavior identification supporting assessment at a rate of $45.63 per 15 minutes;</text> </paragraph> <paragraph num="(4)"> <text>Adaptive exposure behavior treatment with protocol modification at a rate of $45.63 per 15 minutes;</text> </paragraph> <paragraph num="(5)"> <text>Group adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$9.13 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$7.30 per 15 minutes, per participant, when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$6.08 per 15 minutes, per participant, when provided by an RBT or BT;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes;</text> </paragraph> <paragraph num="(7)"> <text>Multiple-family group adaptive behavior treatment guidance at a rate of $11.26 per 15 minutes per family;</text> </paragraph> <paragraph num="(8)"> <text>Family adaptive behavior treatment guidance with the participant present at a rate of:</text> <paragraph num="(a)"> <text>$33.46 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$18.25 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Family adaptive behavior treatment guidance without the participant present at a rate of:</text> <paragraph num="(a)"> <text>$18.25 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$10.65 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Behavior identification reassessment at a rate of $33.46 per 15 minutes;</text> </paragraph> <paragraph num="(11)"> <text>Group adaptive treatment with protocol modification at a rate of $9.13 per 15 minutes per participant;</text> </paragraph> <paragraph num="(12)"> <text>Adaptive behavior treatment direction at a rate of $33.46 per 15 minutes;</text> </paragraph> <paragraph num="(13)"> <text>Adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$21.30 per 15 minutes when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$18.25 per 15 minutes when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$16.73 per 15 minutes when provided by an RBT or BT; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Adaptive behavior treatment planning:</text> <paragraph num="(a)"> <text>At a rate of $33.46 per 15 minutes; and</text> </paragraph> <paragraph num="(b)"> <text>For a maximum of 4 hours per month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Effective July 1, 2023 through December 31, 2023, reimbursement for ABA services covered under this chapter is as follows:</text> <paragraph num="(1)"> <text>Behavior identification assessment at a rate of $34.46 per 15 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Behavior identification assessment follow-up at a rate of $17.23 per 15 minutes;</text> </paragraph> <paragraph num="(3)"> <text>Exposure behavior identification supporting assessment at a rate of $47.00 per 15 minutes;</text> </paragraph> <paragraph num="(4)"> <text>Adaptive exposure behavior treatment with protocol modification at a rate of $47.00 per 15 minutes;</text> </paragraph> <paragraph num="(5)"> <text>Group adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$9.40 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$7.52 per 15 minutes, per participant, when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$6.26 per 15 minutes, per participant, when provided by an RBT or BT;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes;</text> </paragraph> <paragraph num="(7)"> <text>Multiple-family group adaptive behavior treatment guidance at a rate of $11.60 per 15 minutes per family;</text> </paragraph> <paragraph num="(8)"> <text>Family adaptive behavior treatment guidance with the participant present at a rate of:</text> <paragraph num="(a)"> <text>$34.46 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$18.80 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Family adaptive behavior treatment guidance without the participant present at a rate of:</text> <paragraph num="(a)"> <text>$18.80 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$10.97 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Behavior identification reassessment at a rate of $34.46 per 15 minutes;</text> </paragraph> <paragraph num="(11)"> <text>Group adaptive treatment with protocol modification at a rate of $9.40 per 15 minutes per participant;</text> </paragraph> <paragraph num="(12)"> <text>Adaptive behavior treatment direction at a rate of $34.46 per 15 minutes;</text> </paragraph> <paragraph num="(13)"> <text>Adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$21.94 per 15 minutes when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$18.80 per 15 minutes when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$17.23 per 15 minutes when provided by an RBT or BT; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Adaptive behavior treatment planning:</text> <paragraph num="(a)"> <text>At a rate of $34.46 per 15 minutes; and</text> </paragraph> <paragraph num="(b)"> <text>For a maximum of 4 hours per month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Effective January 1, 2024 through June 30, 2024, reimbursement for ABA services covered under this chapter is as follows:</text> <paragraph num="(1)"> <text>Behavior identification assessment at a rate of $37.22 per 15 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Behavior identification assessment follow-up at a rate of $18.61 per 15 minutes;</text> </paragraph> <paragraph num="(3)"> <text>Exposure behavior identification supporting assessment at a rate of $50.76 per 15 minutes;</text> </paragraph> <paragraph num="(4)"> <text>Adaptive exposure behavior treatment with protocol modification at a rate of $50.76 per 15 minutes;</text> </paragraph> <paragraph num="(5)"> <text>Group adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$10.15 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$8.12 per 15 minutes, per participant, when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$6.76 per 15 minutes, per participant, when provided by an RBT or BT;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Adaptive behavior treatment with protocol modification at a rate of $37.22 per 15 minutes;</text> </paragraph> <paragraph num="(7)"> <text>Multiple-family group adaptive behavior treatment guidance at a rate of $12.53 per 15 minutes per family;</text> </paragraph> <paragraph num="(8)"> <text>Family adaptive behavior treatment guidance with the participant present at a rate of:</text> <paragraph num="(a)"> <text>$37.22 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$20.30 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Family adaptive behavior treatment guidance without the participant present at a rate of:</text> <paragraph num="(a)"> <text>$20.30 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$11.85 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Behavior identification reassessment at a rate of $37.22 per 15 minutes;</text> </paragraph> <paragraph num="(11)"> <text>Group adaptive treatment with protocol modification at a rate of $10.15 per 15 minutes per participant;</text> </paragraph> <paragraph num="(12)"> <text>Adaptive behavior treatment direction at a rate of $37.22 per 15 minutes;</text> </paragraph> <paragraph num="(13)"> <text>Adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$23.70 per 15 minutes when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$20.30 per 15 minutes when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$18.61 per 15 minutes when provided by an RBT or BT; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Adaptive behavior treatment planning:</text> <paragraph num="(a)"> <text>At a rate of $37.22 per 15 minutes; and</text> </paragraph> <paragraph num="(b)"> <text>For a maximum of 4 hours per month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Effective July 1, 2024, reimbursement for ABA services covered under this chapter is as follows:</text> <paragraph num="(1)"> <text>Behavior identification assessment at a rate of $38.34 per 15 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Behavior identification assessment follow-up at a rate of $19.17 per 15 minutes;</text> </paragraph> <paragraph num="(3)"> <text>Exposure behavior identification supporting assessment at a rate of $52.28 per 15 minutes;</text> </paragraph> <paragraph num="(4)"> <text>Adaptive exposure behavior treatment with protocol modification at a rate of $52.28 per 15 minutes;</text> </paragraph> <paragraph num="(5)"> <text>Group adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$10.45 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$8.36 per 15 minutes, per participant, when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$6.96 per 15 minutes, per participant, when provided by an RBT or BT;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Adaptive behavior treatment with protocol modification at a rate of $38.34 per 15 minutes;</text> </paragraph> <paragraph num="(7)"> <text>Multiple-family group adaptive behavior treatment guidance at a rate of $12.91 per 15 minutes per family;</text> </paragraph> <paragraph num="(8)"> <text>Family adaptive behavior treatment guidance with the participant present at a rate of:</text> <paragraph num="(a)"> <text>$38.34 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$20.91 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Family adaptive behavior treatment guidance without the participant present at a rate of:</text> <paragraph num="(a)"> <text>$20.91 per 15 minutes when provided by a licensed psychologist or an LBA; and</text> </paragraph> <paragraph num="(b)"> <text>$12.21 per 15 minutes when provided by a BCaBA;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Behavior identification reassessment at a rate of $38.34 per 15 minutes;</text> </paragraph> <paragraph num="(11)"> <text>Group adaptive treatment with protocol modification at a rate of $10.45 per 15 minutes per participant;</text> </paragraph> <paragraph num="(12)"> <text>Adaptive behavior treatment direction at a rate of $38.34 per 15 minutes;</text> </paragraph> <paragraph num="(13)"> <text>Adaptive behavior treatment by protocol at a rate of:</text> <paragraph num="(a)"> <text>$24.41 per 15 minutes when provided by a licensed psychologist or an LBA;</text> </paragraph> <paragraph num="(b)"> <text>$20.91 per 15 minutes when provided by a BCaBA; and</text> </paragraph> <paragraph num="(c)"> <text>$19.17 per 15 minutes when provided by an RBT or BT; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Adaptive behavior treatment planning:</text> <paragraph num="(a)"> <text>At a rate of $38.34 per 15 minutes; and</text> </paragraph> <paragraph num="(b)"> <text>For a maximum of 4 hours per month.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeals Procedures."> <text>Appeal procedures are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>This chapter shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 7, 2016 (43:22 Md. R. 1218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049); December 11, 2023 (50:24 Md. R. 1041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H, I amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02J adopted effective December 11, 2023 (50:24 Md. R. 1041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 11, 2025 (52:24 Md. R. 1197</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, C amended effective December 11, 2023 (50:24 Md. R. 1041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective March 12, 2018 (45:5 Md. R. 285)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F adopted effective March 12, 2018 (45:5 Md. R. 285)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 12, 2018 (45:5 Md. R. 285); December 11, 2023 (50:24 Md. R. 1041); December 11, 2025 (52:24 Md. R. 1197)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G adopted effective December 12, 2022 (49:25 Md. R. 1049)</annotation> </annotations> </chapter> <chapter num="29" heading="Residential Treatment Center Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Active treatment” means inpatient psychiatric services which involve implementation of a professionally developed and supervised individual plan of care described in 42 CFR §441.155, that is:</text> <paragraph num="(a)"> <text>Developed and implemented no later than 14 days after admission; and</text> </paragraph> <paragraph num="(b)"> <text>Designed to achieve the recipient's discharge from inpatient status at the earliest possible time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Acute psychiatric services” mean psychiatric services rendered in response to a severe psychiatric condition requiring intervention in order to bring the patient's symptoms under control.</text> </paragraph> <paragraph num="(3)"> <text>“Admissions team” means an independent team that certifies the need for services (as specified in 42 CFR §§441.152 and 441.153). The certification shall be made by an independent team that:</text> <paragraph num="(a)"> <text>Includes a physician;</text> </paragraph> <paragraph num="(b)"> <text>Has competence in diagnosis and treatment of mental illness, preferably in child psychiatry; and</text> </paragraph> <paragraph num="(c)"> <text>Has knowledge of the individual's situation.</text> </paragraph> </paragraph> <paragraph num="(3-1)"> <text>“Children's residential treatment center” means a residential treatment center that admits patients 12 years old and younger.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Department of Human Services” means the department of State government encompassing the Family Investment Administration, the Social Services Administration, and the Child Support Enforcement Administration.</text> </paragraph> <paragraph num="(6)"> <text>“Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining a person's eligibility for Medical assistance.</text> </paragraph> <paragraph num="(7)"> <text>“Individual plan of care” means a written plan developed for each recipient in accordance with 42 CFR §§456.180—456.181, and §§456.280—456.281, and defined in 42 CFR §441.155 (individual plan of care). The plan of care shall:</text> <paragraph num="(a)"> <text>Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral, and developmental aspects of the recipient's situation and reflects the need for inpatient psychiatric care;</text> </paragraph> <paragraph num="(b)"> <text>Be developed by a team of professionals in consultation with the recipient and the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge;</text> </paragraph> <paragraph num="(c)"> <text>State treatment objectives;</text> </paragraph> <paragraph num="(d)"> <text>Prescribe an integrated program of therapies, activities, and experiences designed to meet the objectives; and</text> </paragraph> <paragraph num="(e)"> <text>Include, at an appropriate time, post-discharge plans and coordination of inpatient services with partial discharge plans and related community services to ensure continuity of care with the recipient's family, school, and community upon discharge.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Local department of social services” means that unit of the Baltimore City or county social services department under the supervision of the Family Investment Administration.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(10)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(10-1)"> <text>“Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat an individual for a diagnosis set forth in COMAR 10.67.08.02M.</text> </paragraph> <paragraph num="(11)"> <text>“Physician” means an individual who is currently licensed to practice medicine in the state in which his practice is located.</text> </paragraph> <paragraph num="(12)"> <text>“Preauthorization” means an approval required from the Department or its designee and transmitted to the provider before services can be rendered.</text> </paragraph> <paragraph num="(13)"> <text>“Program” means the Maryland Medical Assistance Program, which administers comprehensive medical and health-related benefits to indigent and medically indigent persons.</text> </paragraph> <paragraph num="(14)"> <text>“Provider” means a residential treatment center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(15)"> <text>“Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(16)"> <text>“Recipient under 21 years old” means a recipient who is either:</text> <paragraph num="(a)"> <text>Under 21 years old; or</text> </paragraph> <paragraph num="(b)"> <text>Twenty-one years old and received residential treatment center services immediately before the recipient reached age 21. The recipient continues to be recognized as a recipient under 21 years old until the earlier of the date the recipient either:</text> <paragraph num="(i)"> <text>No longer requires inpatient psychiatric services; or</text> </paragraph> <paragraph num="(ii)"> <text>Reaches 22 years old.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(18)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure Requirements."> <paragraph num="A."> <text>In order to participate in the Program a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department in accordance with requirements of Health-General Article, §19-308, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Meet the standards established by COMAR 10.07.04; and</text> </paragraph> <paragraph num="(3)"> <text>Obtain other licenses as may be required by applicable State and local laws.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician providing services in a residential treatment center shall be licensed and legally authorized to practice medicine in the state in which the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Conditions for Participation."> <text>To participate in the Program as a residential treatment center for emotionally disturbed children and adolescents, a provider shall:</text> <paragraph num="A."> <text>Meet the requirements for participation as defined in 42 CFR §440.160 (inpatient psychiatric services for individuals under 21 years old) and have acute psychiatric services that meet the requirements of 42 CFR Part 441, Subpart D (inpatient psychiatric services for individuals under 21 years old in psychiatric facilities or programs).</text> </paragraph> <paragraph num="B."> <text>Be accredited by the Joint Commission on Accreditation of Healthcare Organizations.</text> </paragraph> <paragraph num="C."> <text>Meet the applicable conditions and requirements of Regulation .04 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Apply for participation in the Program by completing the application form designated by the Program.</text> </paragraph> <paragraph num="E."> <text>Be approved for participation and be assigned a provider account number by the Department.</text> </paragraph> <paragraph num="F."> <text>Have a current written agreement with the Program.</text> </paragraph> <paragraph num="G."> <text>Verify the licenses and credentials of all professionals employed by or under contract with the residential treatment center to provide services.</text> </paragraph> <paragraph num="H."> <text>Verify the recipient's eligibility.</text> </paragraph> <paragraph num="I."> <text>Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap, unless limitations are those specifically required by 42 CFR Subpart D.</text> </paragraph> <paragraph num="J."> <text>Place no restriction on a recipient's right to select providers of the recipient's choice.</text> </paragraph> <paragraph num="K."> <text>Have a written individual plan of care for each recipient as specifically defined by 42 CFR §441.155, and developed by an interdisciplinary team of physicians and other personnel as required in 42 CFR §441.156. The plan shall be reviewed every 30 days by the team to determine that services being provided are or were required on an inpatient basis, and recommend changes in the plan as indicated by the recipient's overall adjustment as an inpatient. The team shall be capable of:</text> <paragraph num="(1)"> <text>Assessing the recipient's immediate and long-range therapeutic needs, developmental priorities, and personal strengths and liabilities;</text> </paragraph> <paragraph num="(2)"> <text>Assessing the potential resources of the recipient's family which includes the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge;</text> </paragraph> <paragraph num="(3)"> <text>Setting treatment objectives; and</text> </paragraph> <paragraph num="(4)"> <text>Prescribing therapeutic modalities to achieve the plan's objectives.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Employ for purposes of developing an individual plan of care an interdisciplinary team which shall:</text> <paragraph num="(1)"> <text>Include as a minimum:</text> <paragraph num="(a)"> <text>A Board-eligible or Board-certified psychiatrist,</text> </paragraph> <paragraph num="(b)"> <text>A clinical psychologist who has a doctoral degree and a physician licensed to practice medicine or osteopathy, or</text> </paragraph> <paragraph num="(c)"> <text>A physician licensed to practice medicine or osteopathy with specialized training and experience in the diagnosis and treatment of mental diseases, and a psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Include one of the following:</text> <paragraph num="(a)"> <text>A psychiatric social worker,</text> </paragraph> <paragraph num="(b)"> <text>A registered nurse with specialized training or 1 year's experience in treating mentally ill individuals,</text> </paragraph> <paragraph num="(c)"> <text>An occupational therapist who is licensed, if required by the State, and who has specialized training or 1 year of experience in treating mentally ill individuals,</text> </paragraph> <paragraph num="(d)"> <text>A psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association.</text> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Maintain adequate administrative and medical records for a minimum of 6 years and make them available upon request to the Department or its designee. Adequate administrative and medical records are defined as having documentation sufficient in quantity, scope, and detail to confirm that the residential treatment center services are provided in accordance with this regulation.</text> </paragraph> <paragraph num="N."> <text>Not knowingly contract or employ a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance recipients unless prior written approval has been received from the Department.</text> </paragraph> <paragraph num="O."> <text>Accept payment by the Department as payment in full for services rendered and make no additional charge to any person for covered service.</text> </paragraph> <paragraph num="P."> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient or his family.</text> </paragraph> <paragraph num="Q."> <text>Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient or his family.</text> </paragraph> <paragraph num="R."> <text>Meet the requirements for admission to regional institutes for children and adolescents, established by COMAR 10.21.06.</text> </paragraph> <paragraph num="S."> <text>Agree that if the Program denies payment due to the provider's failure to satisfy mandatory federal requirements as specified in 42 CFR Part 441, Subpart D—Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs, the provider may not seek payment from the recipient or his family.</text> </paragraph> <paragraph num="T."> <text>Comply with all requirements for the delivery of mental health services contained in COMAR 10.67.08.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers inpatient psychiatric services for the diagnosis, active treatment, and care of recipients under 21 years old with mental disease when the services are:</text> <paragraph num="A."> <text>Medically necessary;</text> </paragraph> <paragraph num="B."> <text>Performed under the direction of a physician;</text> </paragraph> <paragraph num="C."> <text>Certified as necessary by an admissions team before the recipient's admission to the residential treatment center;</text> </paragraph> <paragraph num="D."> <text>In the case of a recipient already residing in the residential treatment center, certified as necessary by the team developing the individual plan of care in accordance with 42 CFR §441.153(b);</text> </paragraph> <paragraph num="E."> <text>For the treatment of a mental illness listed in COMAR 10.67.08.02M.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>A day of inpatient care solely for the purpose of performing diagnostic tests that can be performed on an outpatient basis;</text> </paragraph> <paragraph num="E."> <text>Admissions with a primary diagnosis of alcoholism, drug addiction, or severe brain damage, or the following diagnoses in the ICD-9-CM,</text> <paragraph num="(1)"> <text>294.0—Amnestic syndrome,</text> </paragraph> <paragraph num="(2)"> <text>294.8—Other specified organic brain syndromes (chronic),</text> </paragraph> <paragraph num="(3)"> <text>294.9—Unspecified organic brain syndromes (chronic),</text> </paragraph> <paragraph num="(4)"> <text>299.00—299.8—Psychoses with origin specific to childhood,</text> </paragraph> <paragraph num="(5)"> <text>301.7—Antisocial personality disorder,</text> </paragraph> <paragraph num="(6)"> <text>302.70—302.79—Psychosexual dysfunction,</text> </paragraph> <paragraph num="(7)"> <text>306.0—306.9—Physiological malfunction arising from mental factor,</text> </paragraph> <paragraph num="(8)"> <text>307.0—Special symptoms or syndromes, not elsewhere classified (NEC),</text> </paragraph> <paragraph num="(9)"> <text>307.2 —Tics,</text> </paragraph> <paragraph num="(10)"> <text>307.40—307.49—Specific disorders of sleep of nonorganic origin,</text> </paragraph> <paragraph num="(11)"> <text>307.9—Other and unspecified special symptoms or syndromes (NEC), or</text> </paragraph> <paragraph num="(12)"> <text>316—Psychic factors associated with disease classified elsewhere;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Days of care for recipients remaining in the residential treatment center beyond the length of stay certified by the team which develops the individual plan of care;</text> </paragraph> <paragraph num="G."> <text>Psychiatric services to recipients over 21 years old except as specified in Regulation .01B(16) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <text>The following procedures or services require preauthorization:</text> <paragraph num="A."> <text>Out-of-State admissions. Adequate documentation shall be provided demonstrating that the placement meets one of the conditions as follows:</text> <paragraph num="(1)"> <text>Effective services at an in-State facility are not available;</text> </paragraph> <paragraph num="(2)"> <text>For similar services, an inpatient placement is not currently available in Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>The recipient resides out-of-State and the cost for the out-of-State service is comparable to the cost of similar services in Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services which are determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document sufficient medical necessity except as specified in Regulation .05C of this chapter.</text> </paragraph> <paragraph num="C."> <text>All admissions, which shall comply with the requirements under COMAR 10.09.59.08 for preauthorization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Department will make no direct reimbursement to any State-operated residential treatment center for recipients. The Department will claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these residential treatment centers.</text> </paragraph> <paragraph num="(2)"> <text>The Department will pay the residential treatment center the lesser of the provider’s customary charge or the provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, as required in 42 CFR 413, or on the basis of charges not to exceed $750 per day effective July 1, 2021 through December 31, 2022, or $850 per day effective January 1, 2023. The average increase in the Department’s reimbursement to the provider per inpatient day for each fiscal year over the cost-settled rate for the previous fiscal year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the rate of increase of the Hospital Wage and Price Index plus 1 percentage point, described in 42 CFR §413.40. The target rate percentage increase for each calendar year will equal the prospectively estimated increase in the Hospital Wage and Price Index (market basket index) for each year, plus 1 percentage point. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(a)"> <text>The provider:</text> <paragraph num="(i)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be reimbursed in accordance with the provisions of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An in-State children’s residential treatment center shall be reimbursed the lesser of:</text> <paragraph num="(a)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid;</text> </paragraph> <paragraph num="(b)"> <text>The provider’s per diem cost for covered services established in accordance with Medicare principles of reasonable cost reimbursement as described in 42 CFR 413;</text> </paragraph> <paragraph num="(c)"> <text>Effective July 1, 2021, $750 per day; or</text> </paragraph> <paragraph num="(d)"> <text>Effective January 1, 2023, $850 per day.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department rebases prices in §A(2) and (3) of this regulation between every 2 and 4 years. Prices may be rebased more frequently if the State determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. In years in which rates are not rebased, rates are subject to annual indexing.</text> </paragraph> <paragraph num="(5)"> <text>For purposes of §A(3)(b) of this regulation, the percentage increase in the Department's cost reimbursement to the provider, per inpatient day for each cost reporting year over the cost-settled payment rate for the previous cost reporting year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent.</text> </paragraph> <paragraph num="(6)"> <text>The rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system.</text> </paragraph> <paragraph num="(7)"> <text>Effective July 1, 2021, the rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent.</text> </paragraph> <paragraph num="(8)"> <text>Out-of-State Providers. To be reimbursed for services provided to Maryland Medical Assistance recipients, an out-of-State provider shall be licensed or formally approved as a psychiatric facility or as an inpatient program in a psychiatric facility, either of which is accredited by the Joint Commission on Accreditation of Healthcare Organizations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Recipient's Contribution.</text> <paragraph num="(1)"> <text>The local department of social services or the State-operated facility's fiscal agent shall determine the amount the recipient has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall collect from the recipient that amount as shown available on the designated form.</text> </paragraph> <paragraph num="(3)"> <text>The provider may not collect a total amount, including the amount the recipient has available and the Department's payment, which exceeds the provider's rate established by the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>The provider shall show to the Department sums collected from the recipient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall submit request for payment on the form designated by the Department.</text> </paragraph> <paragraph num="D."> <text>The provider shall submit, with invoices, properly completed attachments as requested by the Department.</text> </paragraph> <paragraph num="E."> <text>A provider may not bill the Program a charge exceeding that charged the general public for similar services.</text> </paragraph> <paragraph num="F."> <text>The provider may not bill the Department for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department will make no direct payment to the recipient.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="I."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for, or to reimburse, the recipient for any services covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and the insurance or other source, the provider shall report, within 15 days after the close of each month, on a form designated by the Department, the amount paid by the Program, and the insurance or the other source, whichever is less, and refund the total amount of the lesser of the two payments reported to the Program at that time.</text> </paragraph> <paragraph num="B."> <text>If refund of a payment as specified in §A, of this regulation, is not made, the Department will have the right to reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the Program;</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action.</text> </paragraph> <paragraph num="C."> <text>A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that it no longer honors Medical Assistance cards before it renders additional services.</text> </paragraph> <paragraph num="D."> <text>The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall:</text> <paragraph num="(1)"> <text>Establish the:</text> <paragraph num="(a)"> <text>Effective date of the proposed action; and</text> </paragraph> <paragraph num="(b)"> <text>Reasons for the proposed action; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Advise the provider of the right to appeal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Cost Reporting."> <paragraph num="A."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Include, for purposes of cost finding, direct and indirect costs applicable to recipient care;</text> </paragraph> <paragraph num="(2)"> <text>In the cost report, specifically identify costs associated with related organizations;</text> </paragraph> <paragraph num="(3)"> <text>Maintain adequate financial records and statistical data, according to generally accepted accounting principles and procedures, which shall provide, as a minimum:</text> <paragraph num="(a)"> <text>Maintenance of:</text> <paragraph num="(i)"> <text>A chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements,</text> </paragraph> <paragraph num="(ii)"> <text>An appropriate time reporting system for all personnel and proper payroll authorizations and vouchers,</text> </paragraph> <paragraph num="(iii)"> <text>Records on all assets capitalized and depreciation on the assets,</text> </paragraph> <paragraph num="(iv)"> <text>Appropriate records of client days,</text> </paragraph> <paragraph num="(v)"> <text>Records on an accrual basis,</text> </paragraph> <paragraph num="(vi)"> <text>A daily midnight bed census by recipient name in a form prescribed by the Department, although use of the prescribed form may be waived by the Department or its designee when a provider demonstrates the ability to maintain a superior system of census information,</text> </paragraph> <paragraph num="(vii)"> <text>Other records as required by the Department, and</text> </paragraph> <paragraph num="(viii)"> <text>A Maryland Medical Assistance log on forms prescribed by the Department;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Proper reference to supporting invoices, vouchers, or other forms of original evidence; and</text> </paragraph> <paragraph num="(c)"> <text>A provision for payment by check, although when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours, with records for each fiscal year's cost report to be retained for 6 years after the filing date of the cost report specified in §A(5) of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Submit financial and statistical cost reports to the Department or its designee:</text> <paragraph num="(a)"> <text>In a prescribed form; and</text> </paragraph> <paragraph num="(b)"> <text>Within 3 months after the end of the provider's fiscal year unless the:</text> <paragraph num="(i)"> <text>Department grants the provider an extension, or</text> </paragraph> <paragraph num="(ii)"> <text>Provider discontinues participation in the Program;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Be considered for an extension as cited in §A(5)(b)(i) of this regulation, which may be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; and</text> </paragraph> <paragraph num="(7)"> <text>If it discontinues participation, submit financial and statistical data to the Department within 45 days after the effective date of termination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>For cost reports requested in §A(5) of this regulation, which have not been received within the 3-month time period and when an extension has not been granted:</text> <paragraph num="(a)"> <text>Withhold from the provider a maximum of 5 percent of the current interim payment starting at the beginning of the second calendar month after the month in which the report is due,</text> </paragraph> <paragraph num="(b)"> <text>Continue withholding as described in §B(1)(a) of this regulation in any subsequent calendar months, and</text> </paragraph> <paragraph num="(c)"> <text>Retain all withholdings until final cost settlement is completed;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, impose one or more sanctions as provided for in Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, make final cost settlement for that fiscal year at the last final per diem rates for which the Department has verified costs for that facility, if the rates established do not exceed the maximum per diem rates in effect when the facility was last field verified.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For purposes of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> <paragraph num="D."> <text>The Program may not make an initial retroactive adjustment when cost reports are received, and tentative settlements may not be made before final settlement.</text> </paragraph> <paragraph num="E."> <text>When a provider receives notification of final settlement as set forth in Regulation .14A(4) of this chapter and an appeal is filed, undisputed amounts of settlement may not be paid to the appropriate recipients until final findings of the appeal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Interim Rates."> <paragraph num="A."> <text>A provider shall have its interim rate updated annually.</text> </paragraph> <paragraph num="B."> <text>A provider's interim rate shall be adjusted at the beginning of each fiscal year, by applying the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, subject to the limitations in Regulation .07A of this chapter, to the provider's interim rate in effect on the last day of the preceding fiscal year.</text> </paragraph> <paragraph num="C."> <text>The rate established in §B of this regulation is in effect until such time as a new rate can be calculated as specified in §§D—F of this regulation.</text> </paragraph> <paragraph num="D."> <text>The provider shall submit annually, with the cost report described in Regulation .12 of this chapter, schedules detailing projected increases/decreases from the year just ended to the current year.</text> </paragraph> <paragraph num="E."> <text>The provider shall submit a calculation reflecting the rate being requested for the current year.</text> </paragraph> <paragraph num="F."> <text>The Department or its designee shall use the submitted cost report, schedules, calculations, and other information as appropriate to calculate an updated interim rate for the current year.</text> </paragraph> <paragraph num="G."> <text>The rate established in accordance with §F of this regulation shall be implemented for the remainder of the fiscal year with no retroactive supplemental billing or payment for differences in rates.</text> </paragraph> <paragraph num="H."> <text>Providers may request an interim rate revision:</text> <paragraph num="(1)"> <text>If the revised interim rate exceeds the current rate by 7 percent; and</text> </paragraph> <paragraph num="(2)"> <text>Not more than two times during a fiscal year.</text> </paragraph> </paragraph> <paragraph num="I."> <text>A request for a revised interim rate shall include, at a minimum:</text> <paragraph num="(1)"> <text>A completed cost report based on a minimum of 3 months of recent actual cost and statistics;</text> </paragraph> <paragraph num="(2)"> <text>An adjusted trial balance covering the cost report period in §I(1) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>A calculation reflecting the revised rate being requested.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A new provider seeking payment for services shall submit to the Department or its designee a projected budgeted cost report and other appropriate information for the period from the beginning of its operations as a provider to the end of its first fiscal year, along with a projected charge rate schedule, for establishment of an initial interim rate by the Department or its designee, subject to the limitations in Regulation .07A of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Field Verification."> <paragraph num="A."> <text>The Department or its designee shall:</text> <paragraph num="(1)"> <text>Conduct a field verification, at least every 3 years, of the reported costs of each facility participating in the Program, if the amount of the facility's reimbursement would justify the expense of a field verification;</text> </paragraph> <paragraph num="(2)"> <text>Desk review the reported costs of the facility in those years when a field verification is not conducted;</text> </paragraph> <paragraph num="(3)"> <text>Notify each provider participating in the Program of the results of the field verification or desk review; and</text> </paragraph> <paragraph num="(4)"> <text>Calculate final settlements by comparing the verified allowable reimbursement to the interim reimbursement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Appeal Findings.</text> <paragraph num="(1)"> <text>After the Department receives the findings of an appeal filed under Regulation .10 of this chapter, the Department shall determine the amount that is due either to the Program or to the provider, and notify the provider of that amount.</text> </paragraph> <paragraph num="(2)"> <text>If the provider has accepted the determination made under §B(1) of this regulation, and within 60 days after the provider receives the notification under §B(1) of this regulation, the Program shall pay the amount the Department has determined is due the provider, if any.</text> </paragraph> <paragraph num="(3)"> <text>Subject to the provisions of §B(5) and (6) of this regulation, within 60 days after the provider receives the notification under §B(1) of this regulation, the provider shall pay the amount due the Program, if any.</text> </paragraph> <paragraph num="(4)"> <text>After the expiration of the 60-day period in §B(3) of this regulation, the Department may, in addition to the sanctions provided for in Regulation .09 of this chapter, recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider.</text> </paragraph> <paragraph num="(5)"> <text>If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule.</text> </paragraph> <paragraph num="(6)"> <text>The Department shall establish a longer payment schedule if, in the Department's reasonable judgment, failure to grant a longer payment schedule would:</text> <paragraph num="(a)"> <text>Result in financial hardship to the provider; or</text> </paragraph> <paragraph num="(b)"> <text>Have an adverse effect on the quality of patient care furnished by the facility.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Change of Ownership."> <paragraph num="A."> <text>The current owner of a residential treatment center shall:</text> <paragraph num="(1)"> <text>Notify the Program of the contemplated sale of a facility or controlling interest in it not less than 30 days before the date of the change of ownership; and</text> </paragraph> <paragraph num="(2)"> <text>Before the date of the change of ownership, post an indemnity bond or standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser will assume and be responsible for all financial obligations of the current owner.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The bond or standby letter of credit under §A(2) of this regulation shall be in the amount of 1 month's Program billings for each unsettled fiscal period outstanding. This amount shall equal the median monthly payment for each unsettled fiscal period.</text> </paragraph> <paragraph num="C."> <text>The new owner of a residential treatment center shall:</text> <paragraph num="(1)"> <text>Notify the Program of the intent to purchase an existing facility or controlling interest in it, and the desire to enroll in the Program, not less than 30 days before the date of the change of ownership; and</text> </paragraph> <paragraph num="(2)"> <text>Enter into a provider agreement with the Department before being assigned new interim per diem rates.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Interim Per Diem Rates.</text> <paragraph num="(1)"> <text>For the purpose of establishing interim per diem rates, the new owner in an arm's length change of ownership shall be treated as a new provider under the provisions of Regulation .13J of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall establish new interim per diem rates within 90 days after the date of the change of ownership, applicable retroactively to the date of the change of ownership, if the information specified in Regulation .13J of this chapter is submitted to the Department or its designee within 60 days after the date of the change of ownership.</text> </paragraph> <paragraph num="(3)"> <text>Until the new interim per diem rates are established, the new provider may be reimbursed at the interim per diem rates that existed before the date of the change of ownership.</text> </paragraph> <paragraph num="(4)"> <text>Failure by the provider to provide data for interim rate determination within 60 days after the change of ownership may result in temporary withholding of the interim per diem payments.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to comply with §§A and B of this regulation shall result in all unsettled fiscal periods to be immediately settled at 90 percent of the rates used for the most recently settled fiscal period, and amounts due shall be paid immediately.</text> </paragraph> <paragraph num="F."> <text>If the provider elects to file an appeal against any action taken under the provisions of §E of this regulation, any amount due to the Department shall be escrowed pending the final outcome of the appeal.</text> </paragraph> <paragraph num="G."> <text>The Department, in its sole discretion, may waive any of the requirements of this regulation based on exceptional circumstances.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective July 1, 1986 (13:13 Md. R. 1474); adopted permanently effective December 1, 1986 (13:24 Md. R. 2559)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571); April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03—.06 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03, .04, .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective November 1, 1992 (19:21 Md. R. 1891)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective February 6, 1989 (16:2 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective February 12, 2007 (34:3 Md. R. 298); April 5, 2010 (37:7 Md. R. 571); July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D adopted effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulations .12—.14 adopted effective November 23, 1992 (19:23 Md. R. 2041)</annotation> <annotation type="History" subtype="Administrative History">Regulations .12B and .13 amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B, C amended effective February 12, 2007 (34:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective February 12, 2007 (34:3 Md. R. 298)</annotation> </annotations> </chapter> <chapter num="30" heading="Statewide Evaluation and Planning Services"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to codify policy regarding comprehensive evaluations performed for the purpose of determining eligibility for services or informing individuals of available services or as required for Geriatric Evaluation Services (GES) or Preadmission Screening and Resident Review (PASRR).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Comprehensive evaluation” means the assessment performed by a nurse or social worker, or both, using the tools designated by the Department, of a participant’s medical, social, and functional status by:</text> <paragraph num="(a)"> <text>Direct observation of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Contact, as appropriate, with the participant's representative; and</text> </paragraph> <paragraph num="(c)"> <text>Financial eligibility screening.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Financial eligibility screening” means the determination of whether an individual qualifies financially as a participant.</text> </paragraph> <paragraph num="(4)"> <text>“Geriatric Evaluation Services (GES)” means the assessment that is required to admit an individual to a State facility or Veteran’s Administration hospital.</text> </paragraph> <paragraph num="(5)"> <text>“Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(6)"> <text>“Nurse practitioner” means a person who is licensed as a nurse practitioner in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(7)"> <text>“Participant” means a Medicaid recipient or an individual who would be able to establish financial eligibility under the Program within 6 months of admission to a nursing facility, whose needs may not be adequately met in an episodic ambulatory care setting, and who may require continuing institutional or community based long-term care services.</text> </paragraph> <paragraph num="(8)"> <text>“Plan of care” means the written long term care plan composed of a comprehensive evaluation of the participant’s health status including:</text> <paragraph num="(a)"> <text>Pertinent diagnoses;</text> </paragraph> <paragraph num="(b)"> <text>Psychosocial status;</text> </paragraph> <paragraph num="(c)"> <text>Functional status; and</text> </paragraph> <paragraph num="(d)"> <text>Type of services recommended.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Preadmission Screening and Resident Review (PASRR)” means the screening or reviewing of all individuals with mental illness or intellectual disability who apply to or reside in Medicaid-certified nursing facilities.</text> </paragraph> <paragraph num="(10)"> <text>“Program” has the same meaning as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(11)"> <text>“Provider” means a local health department, or when necessary, a contracted agency:</text> <paragraph num="(a)"> <text>Providing the comprehensive evaluation through an appropriate agreement with the Department and identified as a Program provider by the issuance of an individual account number;</text> </paragraph> <paragraph num="(b)"> <text>Employing nurses and social workers to provide the comprehensive evaluation; and</text> </paragraph> <paragraph num="(c)"> <text>Demonstrating experience in providing assessment and evaluation services and in developing plans of care.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Provider agreement” means a contract between the Department and the provider of STEPS specifying the:</text> <paragraph num="(a)"> <text>Services to be performed;</text> </paragraph> <paragraph num="(b)"> <text>Methods of operation; and</text> </paragraph> <paragraph num="(c)"> <text>Financial and legal requirements which shall be in force before Program participation.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Psychiatrist” means a person who is licensed as a psychiatrist in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(14)"> <text>“Psychologist” means a person who is licensed as a psychologist in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(15)"> <text>“Social worker” means a person who is licensed as a social worker in the jurisdiction in which services are provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Requirements."> <text>The following health professionals providing services under this regulation shall be licensed to practice in the jurisdiction in which services are rendered:</text> <paragraph num="(1)"> <text>Nurses;</text> </paragraph> <paragraph num="(2)"> <text>Nurse practitioners;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatrists;</text> </paragraph> <paragraph num="(4)"> <text>Psychologists; and</text> </paragraph> <paragraph num="(5)"> <text>Social workers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Participation."> <text>Specific requirements for participation in the Program are that providers shall:</text> <paragraph num="A."> <text>Ensure that all individuals performing services under Regulation .05 of this chapter meet the licensure requirements as provided in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Have existing policies and procedures concerning the completion of comprehensive evaluations, and expedition of those evaluations when necessary, that the provider has agreed to perform;</text> </paragraph> <paragraph num="C."> <text>Develop, as appropriate, agreements in order to facilitate access to services and coordinate with local public agencies and other providers;</text> </paragraph> <paragraph num="D."> <text>If approved as a provider of comprehensive evaluations, inform participants of the results of the comprehensive evaluation and of available services; and</text> </paragraph> <paragraph num="E."> <text>Ensure completion, at least every other year, of training on the tools designated by the Department for the purposes of the comprehensive evaluation, by all nurses and social workers providing services under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>The Program reimburses for completed comprehensive evaluations, which include assessment by a nurse, social worker, or both.</text> </paragraph> <paragraph num="B."> <text>The comprehensive evaluation or designated form is to be completed within the following time frames:</text> <paragraph num="(1)"> <text>3 business days for all Geriatric Evaluation Services (GES) and Preadmission Screening and Resident Review (PASRR) for individuals transferring from a hospital to a nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>5 business days for all other PASRR; and</text> </paragraph> <paragraph num="(3)"> <text>15 calendar days for all other purposes.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The comprehensive evaluation shall be completed in-person.</text> </paragraph> <paragraph num="D."> <text>The Department will reimburse for the services listed in §A of this regulation when they are:</text> <paragraph num="(1)"> <text>Rendered to participants as defined in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Completed within the time frame specified in §B of this regulation, unless the Department is notified, in writing, of circumstances that prevent completion within the specified time frame and a temporary, alternative schedule has been approved by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Adequately performed as reflected on the completed form specified by the Department and submitted to the Program as a condition for payment; and</text> </paragraph> <paragraph num="(4)"> <text>Rendered by a provider approved to perform comprehensive evaluations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <paragraph num="A."> <text>The comprehensive evaluation is advisory in nature and is designed to assist individuals in identifying and using appropriate long term care services.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on the qualified recipient’s option to receive the comprehensive evaluation.</text> </paragraph> <paragraph num="C."> <text>The comprehensive evaluation does not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a recipient to select from all available services, including nursing home care, for which the individual is found to be eligible; or</text> </paragraph> <paragraph num="(3)"> <text>The participant's free choice of qualified providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider.</text> </paragraph> <paragraph num="(2)"> <text>Requests for payment shall be submitted on the form specified by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>Effective July 1, 2022, payments for comprehensive evaluations shall be made in accordance with the fee schedule below:</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Interpretive regulatory requirements are as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective October 21, 1986 (13:23 Md. R. 2477); emergency status extended at 14:2 Md. R. 125; adopted permanently effective January 27, 1987 (14:2 Md. R. 129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective December 4, 1990 (17:26 Md. R. 2973); emergency status extended at 18:4 Md. R. 444; amended permanently effective March 18, 1991 (18:5 Md. R. 594)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective December 26, 2011 (38:26 Md. R. 1697)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 11, 2023 (50:24 Md. R. 1041)</annotation> </annotations> </chapter> <chapter num="31" heading="Emergency Service Transporters"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(2)"> <text>“Emergency medical services (EMS) provider " has the meaning stated in Education Article, §13–516, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Emergency service transporter” means a public entity or volunteer fire, rescue, or emergency medical service that provides emergency medical transportation services.</text> </paragraph> <paragraph num="(4)"> <text>“EMS Board” means the State Emergency Medical Services Board established by Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Facility” means a hospital or nursing facility including an intermediate care facility, skilled nursing facility, comprehensive care facility, or extended care facility.</text> </paragraph> <paragraph num="(6)"> <text>“Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention.</text> </paragraph> <paragraph num="(7)"> <text>“Mobile integrated health” means a community-based preventive, primary, chronic, pre-admission, or post-admission health care service provided by an emergency medical services provider to a participant.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(9)"> <text>“Program” has the meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(10)"> <text>“Provider” has the meaning stated in COMAR 10.09.36.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <text>A provider shall meet all licensing requirements:</text> <paragraph num="A."> <text>Set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="B."> <text>In the jurisdiction where the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>To participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Comply with the conditions for participation set forth in COMAR 10.09.36;</text> </paragraph> <paragraph num="B."> <text>Certify that all third-party payers are routinely billed for services;</text> </paragraph> <paragraph num="C."> <text>Retain all documentation, including but not limited to run sheets, for 6 years; and</text> </paragraph> <paragraph num="D."> <text>When delivering mobile integrated health, render services in accordance with the MIH services medical protocols adopted by the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>Emergency Medical Transportation Services. The Program covers the following services when provided by an enrolled emergency service transporter to an eligible participant in response to a 911 call:</text> <paragraph num="(1)"> <text>Medical services delivered at the scene of a 911 response consistent with EMS Board protocols, with or without subsequent transportation;</text> </paragraph> <paragraph num="(2)"> <text>Medical services provided while transporting the participant to a facility, free-standing urgent care center, or other Department-approved destination; and</text> </paragraph> <paragraph num="(3)"> <text>Transportation to a facility, free-standing urgent care center, or other Department-approved destination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mobile Integrated Health Services. The Program covers the following medically necessary mobile integrated health services when delivered by an EMS provider or any team member in the participant’s home or another community-based setting permitted by the EMS Board’s medical protocols:</text> <paragraph num="(1)"> <text>Health assessments;</text> </paragraph> <paragraph num="(2)"> <text>Remote medical diagnostics;</text> </paragraph> <paragraph num="(3)"> <text>Chronic disease monitoring and education;</text> </paragraph> <paragraph num="(4)"> <text>Medication compliance;</text> </paragraph> <paragraph num="(5)"> <text>Immunizations and vaccinations;</text> </paragraph> <paragraph num="(6)"> <text>Laboratory specimen collection;</text> </paragraph> <paragraph num="(7)"> <text>Hospital discharge follow-up care; and</text> </paragraph> <paragraph num="(8)"> <text>Minor medical procedures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Under this chapter, the Program does not cover:</text> <paragraph num="A."> <text>Services not rendered in response to a 911 call unless delivered as part of a mobile integrated health visit;</text> </paragraph> <paragraph num="B."> <text>Services performed or billed by an emergency services transporter that is not enrolled in the Program;</text> </paragraph> <paragraph num="C."> <text>Services rendered by an emergency services transporter in response to a 911 call when the participant refuses medical services and transport of the participant does not occur;</text> </paragraph> <paragraph num="D."> <text>Services rendered to anyone other than an eligible participant;</text> </paragraph> <paragraph num="E."> <text>Services for which proper documentation, including but not limited to run sheets, cannot be provided on request of the Department or its designee;</text> </paragraph> <paragraph num="F."> <text>Services not indicated by the medical protocols adopted by the EMS Board;</text> </paragraph> <paragraph num="G."> <text>Mobile integrated health services delivered to participants younger than 18 years old; and</text> </paragraph> <paragraph num="H."> <text>Services delivered in any setting other than the eligible participant’s home or any community-based site permitted under the medical protocols adopted by the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures for this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>Emergency Medical Transportation Services Reimbursement.</text> <paragraph num="(1)"> <text>Payment for covered services provided in response to each 911 call incident is the lesser of:</text> <paragraph num="(a)"> <text>The amount billed; or</text> </paragraph> <paragraph num="(b)"> <text>Effective July 1, 2022, $150.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective January 1, 2023, payment for covered services provided in response to each 911 call incident that does not result in a transport is the lesser of:</text> <paragraph num="(a)"> <text>The amount billed; or</text> </paragraph> <paragraph num="(b)"> <text>$150.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Mobile Integrated Health Reimbursement.</text> <paragraph num="(1)"> <text>Payment for a mobile integrated health visit is the lesser of:</text> <paragraph num="(a)"> <text>The amount billed; or</text> </paragraph> <paragraph num="(b)"> <text>Effective January 1, 2023, $150.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider shall bill one mobile integrated health service, regardless of the number of clinical services rendered to a participant during the visit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures under this chapter are set forth in COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-114.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 14, 1999 (26:12 Md. R. 925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> </annotations> </chapter> <chapter num="32" heading="Targeted Case Management for HIV-Infected Individuals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Case management” means services which will assist participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, housing, financial, counseling, and other support services.</text> </paragraph> <paragraph num="(2)"> <text>“Case manager” means a physician, nurse, or social worker (refer to Regulation .02 of this chapter) employed by the HIV ongoing case management provider and chosen by the participant or the participant’s legally authorized representative.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means Department as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(4)"> <text>“Entity” means a facility, agency, organization, department, office, corporation, partnership, group or individual.</text> </paragraph> <paragraph num="(5)"> <text>“HIV diagnostic evaluation services” means a bio-psychosocial assessment of a participant and development or revision of an individualized plan of care by a multidisciplinary team convened by an approved HIV diagnostic evaluation services provider.</text> </paragraph> <paragraph num="(6)"> <text>“HIV diagnostic evaluation services provider” means an entity approved by the Department as a provider of HIV diagnostic evaluation services, as defined in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>“HIV-infected individual” means a person determined as positive for human immunodeficiency virus (HIV) infection by the enzyme-linked immunosorbent assay (ELISA) and confirmed by the Western Blot, or another generally accepted diagnostic testing algorithm for HIV infection.</text> </paragraph> <paragraph num="(8)"> <text>“HIV ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider.</text> </paragraph> <paragraph num="(9)"> <text>“HIV ongoing case management provider” means an entity, as defined in Regulation .03 of this chapter, approved by the Department as a provider of ongoing case management services to participants.</text> </paragraph> <paragraph num="(10)"> <text>“HIV-targeted case management” means the provision of HIV diagnostic evaluation services and HIV ongoing case management.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(13)"> <text>“Multidisciplinary team” means the members convened by the HIV diagnostic evaluation services provider to perform a bio-psychosocial assessment of the participant and develop or revise an individualized plan of care.</text> </paragraph> <paragraph num="(14)"> <text>“Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(15)"> <text>“Ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider.</text> </paragraph> <paragraph num="(16)"> <text>“Participant” means a recipient who:</text> <paragraph num="(a)"> <text>Has been diagnosed as HIV-infected or is a child less than 2 years old born to a woman diagnosed as HIV-infected;</text> </paragraph> <paragraph num="(b)"> <text>Elects, or has a legally authorized representative elect in the recipient's behalf, to receive the services available under these regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Is not receiving the same case management services under the Social Security Act, §1915(b), 1915(c), or 1915(g).</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Physician” means a doctor of medicine or osteopathy who is licensed to practice medicine in the jurisdiction in which services are rendered.</text> </paragraph> <paragraph num="(18)"> <text>“Plan of Care” means a goal-directed treatment plan developed and revised by the HIV diagnostic evaluation service provider’s multidisciplinary team that is based on the bio-psychosocial assessment.</text> </paragraph> <paragraph num="(19)"> <text>“Program” means the Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(20)"> <text>“Provider” means the HIV diagnostic evaluation services provider or HIV ongoing case management provider, which offers covered case management services to participants through a provider agreement signed with the Department and which is identified as a Program provider by issuance of an individual account number.</text> </paragraph> <paragraph num="(21)"> <text>“Provider agreement” means a contract between the Department and the provider.</text> </paragraph> <paragraph num="(22)"> <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(23)"> <text>“Social worker” means a person who is in compliance with the social work licensing requirements of the jurisdiction in which services are provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>Registered nurses participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or pursuant to comparable licensing requirements of the jurisdiction in which services are rendered.</text> </paragraph> <paragraph num="B."> <text>Social workers participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Physicians participating in targeted case management for HIV-infected individuals shall be licensed to practice medicine in the jurisdiction in which services are rendered.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Medical Assistance Program are that providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a provider of services covered under this chapter are that the provider shall maintain a record on each participant which meets the Program’s requirements and which includes:</text> <paragraph num="(1)"> <text>Verification of the participant’s HIV-infected status;</text> </paragraph> <paragraph num="(2)"> <text>Verification of the participant’s eligibility for services;</text> </paragraph> <paragraph num="(3)"> <text>A signed consent form by the participant to participate in HIV ongoing case management;</text> </paragraph> <paragraph num="(4)"> <text>The completed bio-psychosocial assessment;</text> </paragraph> <paragraph num="(5)"> <text>The completed plan of care signed by all members of the multidisciplinary team;</text> </paragraph> <paragraph num="(6)"> <text>Documentation for each contact made by the case manager including:</text> <paragraph num="(a)"> <text>Date and subject of contact;</text> </paragraph> <paragraph num="(b)"> <text>Person contacted;</text> </paragraph> <paragraph num="(c)"> <text>Person making the contact;</text> </paragraph> <paragraph num="(d)"> <text>Nature, extent, and unit or units of service provided; and</text> </paragraph> <paragraph num="(e)"> <text>Place of service; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A signed case closure form when HIV ongoing case management services are ended.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific requirements for participation in the Program as an HIV diagnostic evaluation services provider are that the provider shall:</text> <paragraph num="(1)"> <text>Be a physician or a health or social services entity which employs or has a written agreement with physicians, nurses, or social workers for provision of its diagnostic evaluation services who are experienced or trained in the provision of services to HIV-infected individuals;</text> </paragraph> <paragraph num="(2)"> <text>Have a written plan for the implementation of HIV diagnostic evaluation services;</text> </paragraph> <paragraph num="(3)"> <text>Be available to participants at least 8 hours a day, 5 days a week, except on State holidays;</text> </paragraph> <paragraph num="(4)"> <text>Have existing policies and procedures concerning the performance of HIV diagnostic evaluation services;</text> </paragraph> <paragraph num="(5)"> <text>Develop procedures to expedite bio-psychosocial assessments when necessary;</text> </paragraph> <paragraph num="(6)"> <text>Have access to specialty physicians experienced and trained in the provision of services to HIV-infected individuals for consultation, as necessary, concerning a participant’s medical assessment and the medical services recommended in the plan of care.</text> </paragraph> <paragraph num="(7)"> <text>Present a qualified recipient with the option of receiving HIV diagnostic evaluation services and HIV ongoing case management services. If the recipient elects to receive HIV ongoing case management, the provider shall ask the recipient to select from a list of qualified HIV ongoing case management providers.</text> </paragraph> <paragraph num="(8)"> <text>Establish a written agreement with any entity approved as an HIV ongoing case management provider which a participant selects as his or her case manager and agrees to allow the case manager chosen by the participant to:</text> <paragraph num="(a)"> <text>Participate as a member of the multidisciplinary team;</text> </paragraph> <paragraph num="(b)"> <text>Assist with performance of the bio-psychosocial assessment;</text> </paragraph> <paragraph num="(c)"> <text>Assist with the development and revision of the plan of care; and</text> </paragraph> <paragraph num="(d)"> <text>Monitor the participant’s need for a revised bio-psychosocial assessment.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Convene a multidisciplinary team for each participant, to perform the bio-psychosocial assessment and develop or revise an individualized plan of care. The team shall be composed of:</text> <paragraph num="(a)"> <text>The participant;</text> </paragraph> <paragraph num="(b)"> <text>The participant’s legally authorized representative or representatives;</text> </paragraph> <paragraph num="(c)"> <text>Any additional representatives chosen by the participant, if desired;</text> </paragraph> <paragraph num="(d)"> <text>A representative from the HIV diagnostic evaluation services provider which may include any of the following as necessary and appropriate:</text> <paragraph num="(i)"> <text>The participant’s primary care physician;</text> </paragraph> <paragraph num="(ii)"> <text>Nurse;</text> </paragraph> <paragraph num="(iii)"> <text>Current service provider or providers;</text> </paragraph> <paragraph num="(iv)"> <text>Specialty physician; or</text> </paragraph> <paragraph num="(v)"> <text>Social worker; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The participant’s case manager. If employed by the HIV diagnostic evaluation services provider, the case manager may also act as the representative from the provider.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Inform the participant or the participant’s legally authorized representative or representatives of:</text> <paragraph num="(a)"> <text>Recommendations for the plan of care in the bio-psychosocial assessment; and</text> </paragraph> <paragraph num="(b)"> <text>Availability of needed services.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Have the capacity to conduct, at minimum, an annual bio-psychosocial assessment of the participant, unless an earlier assessment is recommended by the case manager or multidisciplinary team.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Specific requirements for participation in the Program as an HIV ongoing case management provider are that the provider shall:</text> <paragraph num="(1)"> <text>Be a health or social services entity employing registered nurses, social workers, or physicians, who are trained and have at least 1 year experience in the provision of services as a case manager. Experience may have been acquired as volunteer work or field placement;</text> </paragraph> <paragraph num="(2)"> <text>Have a written agreement:</text> <paragraph num="(a)"> <text>With any entity approved as an HIV diagnostic evaluation services provider from whom the ongoing case management provider is accepting referrals, and</text> </paragraph> <paragraph num="(b)"> <text>Which permits the case manager to participate as a member of the multidisciplinary team, to have access to the plan of care, and to request a bio-psychosocial assessment and plan of care revision as necessary;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have a written plan for the implementation of HIV ongoing case management services;</text> </paragraph> <paragraph num="(4)"> <text>Have existing policies and procedures concerning the performance of HIV ongoing case management;</text> </paragraph> <paragraph num="(5)"> <text>Provide HIV ongoing case management services to participants who:</text> <paragraph num="(a)"> <text>Are assessed by an HIV diagnostic evaluation services provider;</text> </paragraph> <paragraph num="(b)"> <text>Are recommended for HIV ongoing case management services in the plan of care; and</text> </paragraph> <paragraph num="(c)"> <text>Elect to receive ongoing case management services;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Be available to participants at least 8 hours a day, 5 days a week, except on State holidays;</text> </paragraph> <paragraph num="(7)"> <text>Have established alternatives for managing participants’ medical and social crises during off-hours that will be specified in participants’ individualized plans of care;</text> </paragraph> <paragraph num="(8)"> <text>Have the capacity to meet with the participant face-to-face;</text> </paragraph> <paragraph num="(9)"> <text>Be knowledgeable of the eligibility requirements and application procedures of applicable federal, State, and local government assistance programs; and</text> </paragraph> <paragraph num="(10)"> <text>Maintain a current listing of medical, social, housing assistance, mental health, financial assistance, counseling, and other support services available to HIV-infected individuals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following services when they have been documented as medically necessary:</text> <paragraph num="A."> <text>HIV Diagnostic Evaluation Services.</text> <paragraph num="(1)"> <text>These services shall include, as a unit of service, performance of a bio-psychosocial assessment and development or revision of a recommended plan of care, as well as all other necessary covered services described in §A(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A bio-psychosocial assessment shall be completed within 6 weeks of the participant’s referral for case management services. The assessment shall be performed by the HIV diagnostic evaluation services provider representative on the multidisciplinary team and include:</text> <paragraph num="(a)"> <text>A review of relevant medical and other records, with the participant’s or legal representative’s written consent;</text> </paragraph> <paragraph num="(b)"> <text>A consult with the participant’s attending physician and current providers of medical, social, or other support services, as appropriate;</text> </paragraph> <paragraph num="(c)"> <text>A face-to-face assessment of the participant, preferably at the participant’s residence, to determine:</text> <paragraph num="(i)"> <text>Medical, psychiatric, and substance abuse history, including current medications;</text> </paragraph> <paragraph num="(ii)"> <text>Nutritional status;</text> </paragraph> <paragraph num="(iii)"> <text>Emotional and behavioral status;</text> </paragraph> <paragraph num="(iv)"> <text>Health care coverage;</text> </paragraph> <paragraph num="(v)"> <text>Living situation;</text> </paragraph> <paragraph num="(vi)"> <text>Personal support systems;</text> </paragraph> <paragraph num="(vii)"> <text>Employment and income status;</text> </paragraph> <paragraph num="(viii)"> <text>Health education;</text> </paragraph> <paragraph num="(ix)"> <text>Social support; and</text> </paragraph> <paragraph num="(x)"> <text>Any additional service needs;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A consult, as appropriate, with the participant or the participant’s legally authorized representative or representatives; and</text> </paragraph> <paragraph num="(e)"> <text>All areas listed on the Department’s approved sample bio-psychosocial assessment form.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation of the results of the assessment shall be kept in the participant’s record.</text> </paragraph> <paragraph num="(4)"> <text>The multidisciplinary team will develop a written, individualized plan of care which reflects both the needed and available services being recommended for delivery.</text> </paragraph> <paragraph num="(5)"> <text>The plan of care shall:</text> <paragraph num="(a)"> <text>Be participant-centered and goal-oriented;</text> </paragraph> <paragraph num="(b)"> <text>Be developed and written in collaboration with the participant and other members of the multidisciplinary team;</text> </paragraph> <paragraph num="(c)"> <text>Incorporate findings from the bio-psychosocial assessment;</text> </paragraph> <paragraph num="(d)"> <text>Incorporate findings and recommendations from the multidisciplinary team;</text> </paragraph> <paragraph num="(e)"> <text>Establish a plan for after-hours crises, including medical and social crises, and other emergency situations;</text> </paragraph> <paragraph num="(f)"> <text>Document the proposed frequency of contact with a minimum of 1 face-to-face meeting every 6 months; and</text> </paragraph> <paragraph num="(g)"> <text>Address all areas listed on the Department’s approved sample plan of care form.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>HIV Ongoing Case Management Services.</text> <paragraph num="(1)"> <text>The case manager shall assist with the bio-psychosocial assessment and with development or revision of the plan of care by:</text> <paragraph num="(a)"> <text>Conducting a face-to-face assessment of the participant’s psychosocial status and health care needs and briefing the multidisciplinary team on the findings;</text> </paragraph> <paragraph num="(b)"> <text>Participating in the development or revision of an individualized plan of care for the participant;</text> </paragraph> <paragraph num="(c)"> <text>Encouraging the participant’s and representative’s participation in the multidisciplinary team process; and</text> </paragraph> <paragraph num="(d)"> <text>Linking the participant with any services needed on an emergency basis before the plan of care or revision is finalized.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The HIV ongoing case management provider may be reimbursed for the case manager’s participation as a member of the multidisciplinary team, convened to review the participant’s case by the HIV diagnostic evaluation services provider.</text> </paragraph> <paragraph num="(3)"> <text>The case manager:</text> <paragraph num="(a)"> <text>Participates as a member of the multidisciplinary team convened by the HIV diagnostic evaluation services provider;</text> </paragraph> <paragraph num="(b)"> <text>Assumes responsibility for providing case management services to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Acts as a point of contact for the case; and</text> </paragraph> <paragraph num="(d)"> <text>Implements and monitors the plan of care recommended by the HIV diagnostic evaluation services provider’s multidisciplinary team and approved by the participant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>HIV ongoing case management services shall be provided to participants who:</text> <paragraph num="(a)"> <text>Are recommended in the plan of care as needing case management; and</text> </paragraph> <paragraph num="(b)"> <text>Who elect to receive case management services.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The plan of care shall be implemented as follows:</text> <paragraph num="(a)"> <text>The case manager shall make initial contact with the participant to assure that medical and support referrals were completed and followed-up on;</text> </paragraph> <paragraph num="(b)"> <text>The case manager shall maintain regular contact that will occur at intervals agreed on by the participant and case manager in the plan of care;</text> </paragraph> <paragraph num="(c)"> <text>The case manager or HIV ongoing case management provider, when necessary, shall respond to participant-initiated non-emergency contact within 2 working days;</text> </paragraph> <paragraph num="(d)"> <text>The participant or the participant’s representative or representatives shall be offered a copy of the plan of care;</text> </paragraph> <paragraph num="(e)"> <text>The case manager shall document every direct and indirect contact, including assessing the progress of implementation of the plan of care in the participant’s record;</text> </paragraph> <paragraph num="(f)"> <text>The case manager shall assist the participant with each action plan to reach the goals outlined in the plan of care;</text> </paragraph> <paragraph num="(g)"> <text>The case manager shall advise the participant about available services and service providers, by making referrals to and arrangements with service providers selected by the participant, and by assisting the participant in gaining access to services for which the participant is eligible and which the participant chooses, to include:</text> <paragraph num="(i)"> <text>The full range of Medical Assistance services; and</text> </paragraph> <paragraph num="(ii)"> <text>Other available support services such as medical, social, housing, financial, and counseling;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>The case manager shall provide the participant with any necessary counseling concerning:</text> <paragraph num="(i)"> <text>Government entitlement programs;</text> </paragraph> <paragraph num="(ii)"> <text>Health programs;</text> </paragraph> <paragraph num="(iii)"> <text>Social programs;</text> </paragraph> <paragraph num="(iv)"> <text>Educational programs;</text> </paragraph> <paragraph num="(v)"> <text>Psychological programs;</text> </paragraph> <paragraph num="(vi)"> <text>Financial programs;</text> </paragraph> <paragraph num="(vii)"> <text>Housing programs; and</text> </paragraph> <paragraph num="(viii)"> <text>Other resources;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>The case manager shall follow up with referral sources; and</text> </paragraph> <paragraph num="(j)"> <text>The case manager shall examine the actual service delivery against the plan of care.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The case manager shall monitor and evaluate the participant’s plan of care as follows:</text> <paragraph num="(a)"> <text>Review and check the status of each activity outlined in the plan of care;</text> </paragraph> <paragraph num="(b)"> <text>Modify the action plan or goals to accommodate the participant’s changing needs or changes in service availability;</text> </paragraph> <paragraph num="(c)"> <text>Monitor the plan of care at regular intervals that have been predetermined at the time of the plan of care or more often depending on participant need;</text> </paragraph> <paragraph num="(d)"> <text>Evaluate the plan of care, in collaboration with the participant, at least every 6 months, with input from any members of a multidisciplinary team who have been involved with the participant’s care.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The case manager shall document the following in the participant’s record regarding case closure:</text> <paragraph num="(a)"> <text>Participant notification, including date of closure, reason, and explanation of closure;</text> </paragraph> <paragraph num="(b)"> <text>Participant’s notification of right to re-enter services at a later time;</text> </paragraph> <paragraph num="(c)"> <text>Documentation of coordination and referral to a new provider if desired by the participant; and</text> </paragraph> <paragraph num="(d)"> <text>Documentation of a participant’s non-response to case manager attempts to reach the participant over a 6-month period of time with at least 3 attempts to contact the participant.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>HIV-targeted case management shall be advisory in nature.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on qualified recipients' option to receive HIV case management services.</text> </paragraph> <paragraph num="C."> <text>HIV-targeted case management does not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a recipient to select from all available services for which the individual is found to be eligible; or</text> </paragraph> <paragraph num="(3)"> <text>The participant's free choice of qualified providers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>HIV-targeted case management may not be:</text> <paragraph num="(1)"> <text>Provided as an integral and inseparable part of another covered Program service;</text> </paragraph> <paragraph num="(2)"> <text>Provided as an administrative function;</text> </paragraph> <paragraph num="(3)"> <text>Rendered in connection with the implementation of the Social Security Act, §1915(b) or 1915(c); or</text> </paragraph> <paragraph num="(4)"> <text>Part of institutional discharge planning.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement may not be made for HIV-targeted case management services if the participant is:</text> <paragraph num="(1)"> <text>Eligible to receive services under the Maryland Medicaid Managed Care Program, as defined in COMAR 10.09.62; or</text> </paragraph> <paragraph num="(2)"> <text>Receiving comparable case management services under:</text> <paragraph num="(a)"> <text>The Rare and Expensive Case Management Program, as defined in COMAR 10.09.69; or</text> </paragraph> <paragraph num="(b)"> <text>Under another Program authority.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A participant's case manager may not be a direct services provider for the participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment of HIV-targeted case management services rendered shall be submitted by an approved provider according to procedures as set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="(2)"> <text>Requests for payment shall be submitted on the invoice form specified by the Department. The completed form shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, identification number, and location; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, procedure code or codes, and unit or units of covered service provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providers shall bill the Program for the appropriate fee specified in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>Payments shall be made:</text> <paragraph num="(1)"> <text>Only to 1 provider for a specific type of HIV-targeted case management services rendered to a participant during a specified time period;</text> </paragraph> <paragraph num="(2)"> <text>To an HIV ongoing case management provider that shall be reimbursed in 15-minute increments, which is equal to 1 unit of service. Reimbursement for HIV ongoing case management may not exceed 96 units of service per year following the date of service for the HIV diagnostic evaluation services; and</text> </paragraph> <paragraph num="(3)"> <text>To a provider of HIV-targeted case management services that may not exceed the following fee schedule:</text> <paragraph num="(a)"> <text>For the completion of a bio-psychosocial assessment and development or revision of the plan of care performed by an HIV diagnostic evaluation services provider — $200;</text> </paragraph> <paragraph num="(b)"> <text>For the participation by the case manager in the completion of the bio-psychosocial assessment and development or revision of the plan of care, as specified in Regulation .04B of this chapter up to 6 units of service at a rate of $17.86 per unit of service</text> </paragraph> <paragraph num="(c)"> <text>For HIV ongoing case management, up to 96 units of service, at a rate of $17.86 per unit of service, may be reimbursed per year following completion of the bio-psychosocial assessment and development or revision of the plan of care by a qualified provider of HIV diagnostic evaluation services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures shall be as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 11, 1988 (15:14 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective December 26, 1988 (15:27 Md. R. 3123); adopted permanently effective April 25, 1989 (16:7 Md. R. 811)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective August 28, 1990 (17:19 Md. R. 2318); emergency status expired November 11, 1990; amended permanently effective November 26, 1990 (17:23 Md. R. 2732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 30, 1991 (18:19 Md. R. 2100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D, E amended effective April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective April 2, 2012 (39:6 Md. R. 408)</annotation> </annotations> </chapter> <chapter num="33" heading="Health Homes"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative service organization (ASO)” has the meaning stated in COMAR 10.09.59.01.</text> </paragraph> <paragraph num="(2)"> <text>“ASO system” means the electronic system available to providers which the ASO utilizes to manage Maryland’s Public Behavioral Health System as defined in COMAR 10.09.59.01.</text> </paragraph> <paragraph num="(3)"> <text>“Care management tool” means a system that helps accomplish administrative tasks of the health home, including maintaining a list of health home participants and scheduling and tracking participants clinical appointments.</text> </paragraph> <paragraph num="(4)"> <text>“Care plan” means a written plan of action that is developed and modified to address a patient's specific behavioral, somatic, and social service needs, which is maintained in the individual's medical record and satisfies the following conditions:</text> <paragraph num="(a)"> <text>Meets the requirements of COMAR 10.47.01.04C; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements of COMAR 10.21.21.06C.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Caregiver” means a family member, guardian, or other individual who is not paid to provide care to the participant and who helps the participant achieve and maintain wellness.</text> </paragraph> <paragraph num="(6)"> <text>“Chesapeake Regional Information System for Our Patients (CRISP) means the electronic notification system health home providers are required to use in order to access participant hospital encounter data.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C §1396 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“Full-time equivalent (FTE)” means an employee who works 40 hours per week.</text> </paragraph> <paragraph num="(9)"> <text>“Health home” means a provider designated to offer enhanced care coordination and management services to individuals affected by, or at risk for, chronic conditions, operating under the conditions of this chapter.</text> </paragraph> <paragraph num="(10)"> <text>“Health Information Technology” means electronic systems equipped for the exchange of health data to link services, facilitate communication between health team members and individuals and family caregivers, and enable quality reporting and the review of health outcomes.</text> </paragraph> <paragraph num="(11)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(13)"> <text>“Mental health case management” means services covered under COMAR 10.09.45 and COMAR 10.09.90 which assist participants in gaining access to the full range of mental health services, and necessary medical, social, financial assistance, counseling, educational, housing, and other support services.</text> </paragraph> <paragraph num="(14)"> <text>“Minor” means an individual who is younger than 18 years old.</text> </paragraph> <paragraph num="(15)"> <text>“Mobile treatment services (MTS) program” means a program approved under COMAR 10.63.03.04.</text> </paragraph> <paragraph num="(16)"> <text>“Opioid treatment program (OTP)”, formerly referred to as opioid maintenance therapy (OMT) programs, means a program approved to provide opioid maintenance therapy under COMAR 10.63.03.19.</text> </paragraph> <paragraph num="(17)"> <text>“Participant” means an individual enrolled in a health home funded by the Medical Assistance Program.</text> </paragraph> <paragraph num="(18)"> <text>“Provider” means an individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide health services.</text> </paragraph> <paragraph num="(19)"> <text>“Psychiatric rehabilitation program (PRP)” means a program approved under COMAR 10.63.03.09 for adults, COMAR 10.63.03.10 for minors, or both.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>A PRP serving adults and participating as a health home shall be approved pursuant to COMAR 10.63.03.09.</text> </paragraph> <paragraph num="B."> <text>A PRP serving minors and participating as a health home shall be approved pursuant to COMAR 10.63.03.10.</text> </paragraph> <paragraph num="C."> <text>An MTS program participating as a health home shall be approved pursuant to COMAR10.63.03.04.</text> </paragraph> <paragraph num="D."> <text>An OTP participating as a health home shall be approved to provide opioid maintenance therapy pursuant to COMAR 10.63.03.19.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>An individual is eligible for health home services if the individual:</text> <paragraph num="(1)"> <text>Is a recipient of Maryland Medical Assistance; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the following criteria:</text> <paragraph num="(a)"> <text>Receives outpatient mental health rehabilitation or treatment services with a PRP or MTS program for a serious and persistent mental illness or serious emotional disturbance, and is not currently receiving:</text> <paragraph num="(i)"> <text>1915(i) waiver services; or</text> </paragraph> <paragraph num="(ii)"> <text>Mental health case management; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Receives treatment with an OTP for an opioid substance use disorder and is at risk for additional chronic conditions based on:</text> <paragraph num="(i)"> <text>Current alcohol use, tobacco use, or other non-opioid use; or</text> </paragraph> <paragraph num="(ii)"> <text>A history of alcohol, tobacco, or other non-opioid substance dependence.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A health home participant that is no longer receiving services from their PRP, MTS program, or OTP provider may continue to receive health home services for up to 6 months for the purposes of reengagement or transition to another level of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Health Home Provider Participation."> <text>To be eligible as a health home, a provider shall:</text> <paragraph num="A."> <text>Meet the conditions for provider participation in the Medical Assistance Program, as set forth in COMAR 10.09.36.03;</text> </paragraph> <paragraph num="B."> <text>Meet the approval requirements set forth in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="C."> <text>Be accredited by, or demonstrate evidence of having started the accreditation process from, an approved accrediting body as a health home;</text> </paragraph> <paragraph num="D."> <text>For PRP and MTS health homes serving minors, demonstrate a minimum of 3 years of experience serving minors, which may be achieved as an independent practice or as a member of a broader agency, with exceptions designated by the Department;</text> </paragraph> <paragraph num="E."> <text>At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with CRISP in order to receive hospital encounter alerts;</text> </paragraph> <paragraph num="F."> <text>At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with one of the following organizations in order to receive access to real-time pharmacy data for participants:</text> <paragraph num="(1)"> <text>CRISP; or</text> </paragraph> <paragraph num="(2)"> <text>The State’s ASO;</text> </paragraph> </paragraph> <paragraph num="G."> <text>At the time of enrollment as a health home, have an internal protocol for reviewing and responding to hospital encounter alerts and pharmacy use data;</text> </paragraph> <paragraph num="H."> <text>Directly provide, or subcontract for the provision of, health home services to all participants;</text> </paragraph> <paragraph num="I."> <text>Maintain an electronic database with the ability to, at minimum:</text> <paragraph num="(1)"> <text>Maintain an up-to-date list of all health home participants and their contact information; and</text> </paragraph> <paragraph num="(2)"> <text>Record and review clinical appointments;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Maintain a file for each participant that includes:</text> <paragraph num="(1)"> <text>A form signed by the participant consenting to participate in the health home, including the program’s data-sharing elements;</text> </paragraph> <paragraph num="(2)"> <text>An initial assessment of the participant’s health and social services needs, as described in Regulation .06B(1)(a) of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>A care plan, updated every 6 months, which may be combined with the existing MTS, PRP, or OTP care plan, and includes, at a minimum:</text> <paragraph num="(a)"> <text>The participant’s health home goals;</text> </paragraph> <paragraph num="(b)"> <text>Time frames for meeting the health home goals;</text> </paragraph> <paragraph num="(c)"> <text>Proposed interventions for meeting the health home goals;</text> </paragraph> <paragraph num="(d)"> <text>Relevant community networks and supports;</text> </paragraph> <paragraph num="(e)"> <text>Optimal clinical outcomes for the participant; and</text> </paragraph> <paragraph num="(f)"> <text>Signatures of:</text> <paragraph num="(i)"> <text>The participant or the participant’s parent or guardian; and</text> </paragraph> <paragraph num="(ii)"> <text>The nurse care manager to whom the participant has been assigned in the health home;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Safeguard the confidentiality of the participants’ records in accordance with State and federal laws and regulations;</text> </paragraph> <paragraph num="L."> <text>Provide on-call and crisis intervention services by telephone 24 hours a day, 7 days a week to participants and, as appropriate, their caregivers, or if the participant is a minor, the minor’s parent or guardian;</text> </paragraph> <paragraph num="M."> <text>Be responsible for meeting all health home service requirements, including services performed by a business or individual subcontracted to provide such services;</text> </paragraph> <paragraph num="N."> <text>Convene health home staff meetings every 6 months, at minimum, to plan and implement goals and objectives of functioning as a health home;</text> </paragraph> <paragraph num="O."> <text>Collaborate with MCOs and the ASO to improve participant outcomes; and</text> </paragraph> <paragraph num="P."> <text>Agree to participate in federal and State-required evaluation activities, including:</text> <paragraph num="(1)"> <text>Using the ASO system to:</text> <paragraph num="(a)"> <text>Submit encounters documenting participants’ services at least monthly;</text> </paragraph> <paragraph num="(b)"> <text>Generate monthly reports documenting:</text> <paragraph num="(i)"> <text>Health home service delivery; and</text> </paragraph> <paragraph num="(ii)"> <text>Participants’ health and social outcomes; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Update participant diagnoses and outcomes every 6 months; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completing and submitting to the Department a program assessment every 6 months to demonstrate that:</text> <paragraph num="(a)"> <text>All staffing and other regulatory requirements are being met; and</text> </paragraph> <paragraph num="(b)"> <text>A quality improvement plan is being implemented.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Health Home Provider Staff."> <paragraph num="A."> <text>Health Home Staffing Requirements.</text> <paragraph num="(1)"> <text>Health Home Care Manager.</text> <paragraph num="(a)"> <text>At minimum, the health home shall maintain health home care manager staff at a ratio of .5 FTE per 125 participants.</text> </paragraph> <paragraph num="(b)"> <text>Up to a staffing level of 1 FTE, the health home care manager shall be a:</text> <paragraph num="(i)"> <text>Nurse practitioner meeting the conditions of COMAR 10.27.07; or</text> </paragraph> <paragraph num="(ii)"> <text>Registered nurse licensed pursuant to COMAR 10.27.01 and meeting the conditions of COMAR 10.27.09.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A health home employing more than 1 FTE health home care manager may employ a physician’s assistant licensed pursuant to COMAR 10.32.03.04 to fulfill the additional care manager roles.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Health Home Director.</text> <paragraph num="(a)"> <text>At minimum, the health home shall maintain a health home director at a ratio of .5 FTE per 125 health home participants.</text> </paragraph> <paragraph num="(b)"> <text>A health home requiring a health home director and health home care manager of .5 FTE each may employ 1 FTE individual to serve in both roles, provided that individual meets the requirements for both positions.</text> </paragraph> <paragraph num="(c)"> <text>A health home requiring more than .5 FTE health home director, may choose to designate a lead health home director and fulfill the additional FTE requirement with key management staff who meet the requirements of §A(2)(d)(i) or (ii) of this regulation.</text> </paragraph> <paragraph num="(d)"> <text>The health home director shall:</text> <paragraph num="(i)"> <text>Possess a Bachelor’s degree from an accredited university and 2 years experience in health administration;</text> </paragraph> <paragraph num="(ii)"> <text>Possess a Master’s degree from an accredited university in a related field;</text> </paragraph> <paragraph num="(iii)"> <text>Be licensed as a Registered Nurse with the Maryland Board of Nursing; or</text> </paragraph> <paragraph num="(iv)"> <text>Be licensed as a Physician or be licensed as a Nurse Practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physician or Nurse Practitioner Consultant.</text> <paragraph num="(a)"> <text>At minimum, the health home shall maintain physician or nurse practitioner services at a ratio of one and one half (1.5) hours per health home participant per 12-month period.</text> </paragraph> <paragraph num="(b)"> <text>The physician shall meet the conditions of COMAR 10.32.01.</text> </paragraph> <paragraph num="(c)"> <text>The nurse practitioner shall meet the conditions of COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Administrative Support Staff.</text> <paragraph num="(a)"> <text>The health home shall maintain administrative support at a level sufficient to meet the service provision and reporting requirements of the health home.</text> </paragraph> <paragraph num="(b)"> <text>Administrative support for the health home may be one or a combination of the following:</text> <paragraph num="(i)"> <text>Administrative support staff; or</text> </paragraph> <paragraph num="(ii)"> <text>An electronic care management tool that addresses the administrative health home tasks.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A health home with fewer than 125 participants may form a consortium to share health home staff and costs, contingent upon geographic proximity and Department approval of a plan detailing the proposed collaboration.</text> </paragraph> <paragraph num="C."> <text>Should staffing levels drop below the levels required by this regulation for more than 60 days, the health home shall:</text> <paragraph num="(1)"> <text>Report this to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate that steps have been taken to reach the required staffing levels.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Health home staff members shall be dedicated to health home duties at a level of .5 FTE minimally, and staffing requirements may not be divided among staff at levels below .5 FTE each.</text> </paragraph> <paragraph num="E."> <text>To begin offering health home services, a provider shall have in place a health home director and health home care manager at levels of .5 FTE each, minimally. Additional staff required to meet the staffing levels specified in §§A—D of this regulation shall be hired within 30 days of beginning service provision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>The Department covers the services in §§B—G of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary.</text> </paragraph> <paragraph num="B."> <text>Comprehensive Care Management. The health home shall collaborate to provide comprehensive care management services including:</text> <paragraph num="(1)"> <text>An initial assessment performed prior to the patient's enrollment, which includes:</text> <paragraph num="(a)"> <text>A comprehensive assessment of the participant's physical health, mental health, chemical dependency, and social service needs, signed off on by a physician or nurse practitioner, if no such assessment has been performed in the preceding 6-month period; and</text> </paragraph> <paragraph num="(b)"> <text>Requesting records from the participant's primary care physician and other providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Development of a care plan within 30 days following enrollment, in accordance with Regulation .04J(3) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Delineation of roles, which includes:</text> <paragraph num="(a)"> <text>Assigning each staff member clear roles and responsibilities; and</text> </paragraph> <paragraph num="(b)"> <text>Ensuring that participant care plans identify providers and specialists involved in the participant's care; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Monitoring and reassessment, which includes:</text> <paragraph num="(a)"> <text>Monitoring and documenting participant health status and progress toward care plan goals;</text> </paragraph> <paragraph num="(b)"> <text>Monitoring population health status and service use to determine adherence to or variance from treatment guidelines; and</text> </paragraph> <paragraph num="(c)"> <text>Outcomes evaluation and reporting, which includes using eMedicaid and other available HIT tools such as electronic health records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Care Coordination and Health Promotion.</text> <paragraph num="(1)"> <text>The health home shall coordinate and provide access to:</text> <paragraph num="(a)"> <text>High-quality health care services;</text> </paragraph> <paragraph num="(b)"> <text>Preventive and health promotion services, including education regarding:</text> <paragraph num="(i)"> <text>Mental illness;</text> </paragraph> <paragraph num="(ii)"> <text>Substance use disorders; and</text> </paragraph> <paragraph num="(iii)"> <text>Chronic physical health conditions;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Mental health and substance abuse services;</text> </paragraph> <paragraph num="(d)"> <text>Chronic disease management services; and</text> </paragraph> <paragraph num="(e)"> <text>Long-term care supports and services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The health home shall coordinate services and support, including:</text> <paragraph num="(a)"> <text>Appointment scheduling;</text> </paragraph> <paragraph num="(b)"> <text>Referrals and follow-up monitoring;</text> </paragraph> <paragraph num="(c)"> <text>Hospital discharge processes; and</text> </paragraph> <paragraph num="(d)"> <text>Communication with other providers and supports, including school service providers.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The health home shall assign each participant a health home care manager who is responsible for coordinating the participant's care and ensuring implementation of the care plan.</text> </paragraph> <paragraph num="(4)"> <text>The health home shall develop policies and procedures to facilitate collaboration between primary care, specialist, and behavioral health providers, community-based organizations, and, for minors, school-based providers.</text> </paragraph> <paragraph num="(5)"> <text>The health home shall follow security protocols to protect confidential health information.</text> </paragraph> <paragraph num="(6)"> <text>The health home shall assist participants with the implementation of their care plan, including:</text> <paragraph num="(a)"> <text>Health education specific to a participant's chronic conditions;</text> </paragraph> <paragraph num="(b)"> <text>Development of a plan for self-management;</text> </paragraph> <paragraph num="(c)"> <text>Medication review and education; and</text> </paragraph> <paragraph num="(d)"> <text>Substance use prevention, smoking cessation, obesity reduction, improved nutrition, and increased physical activity.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A health home serving minors shall actively involve parents and families in providing services in accordance with §C(6) of this regulation, including:</text> <paragraph num="(a)"> <text>Identifying conditions for which the minor may be at risk due to family, physical, or social factors; and</text> </paragraph> <paragraph num="(b)"> <text>Working with the minor and parents and families to address the identified conditions.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The health home shall use the ASO system to document, review, and report health promotion services delivered to each participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Comprehensive Transitional Care.</text> <paragraph num="(1)"> <text>The health home shall provide services designed to:</text> <paragraph num="(a)"> <text>Streamline plans of care;</text> </paragraph> <paragraph num="(b)"> <text>Reduce avoidable hospital admissions;</text> </paragraph> <paragraph num="(c)"> <text>Ease the transition to long-term services;</text> </paragraph> <paragraph num="(d)"> <text>Interrupt patterns of frequent hospital emergency department use; and</text> </paragraph> <paragraph num="(e)"> <text>Ensure timely and proper follow-up care across settings, including from:</text> <paragraph num="(i)"> <text>An acute care setting to other settings; and</text> </paragraph> <paragraph num="(ii)"> <text>A pediatric system of care to an adult system of care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The health home shall increase participants' and caregivers' ability to manage care and live safely in the community.</text> </paragraph> <paragraph num="(3)"> <text>The health home shall utilize CRISP to receive alerts of hospital admissions, discharges, or transfers among their health home participants.</text> </paragraph> <paragraph num="(4)"> <text>The health home shall follow up with participants within 2 business days of discharge with a home visit, phone call, or scheduling an on-site appointment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Individual and Family Support Services.</text> <paragraph num="(1)"> <text>Services shall include, but are not limited to:</text> <paragraph num="(a)"> <text>Advocating for individuals and families;</text> </paragraph> <paragraph num="(b)"> <text>Supporting participants in obtaining and adhering to medications and other prescribed treatments;</text> </paragraph> <paragraph num="(c)"> <text>Accessing resources that support participants, including providing referrals for:</text> <paragraph num="(i)"> <text>Community services;</text> </paragraph> <paragraph num="(ii)"> <text>Social support services;</text> </paragraph> <paragraph num="(iii)"> <text>Recovery services; and</text> </paragraph> <paragraph num="(iv)"> <text>Transportation to medically necessary services;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Improving participants' health literacy;</text> </paragraph> <paragraph num="(e)"> <text>Increasing the participant's ability to self-manage care;</text> </paragraph> <paragraph num="(f)"> <text>Facilitating participation in the ongoing revision of the treatment plan; and</text> </paragraph> <paragraph num="(g)"> <text>Providing information on advance directives and health care power of attorney.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The health home shall utilize peer supports, support groups, and self-care programs to:</text> <paragraph num="(a)"> <text>Increase participants' and caregivers' knowledge of the participants' diseases;</text> </paragraph> <paragraph num="(b)"> <text>Increase caregivers' care-management capabilities;</text> </paragraph> <paragraph num="(c)"> <text>Promote participants' adherence to their plan of care; and</text> </paragraph> <paragraph num="(d)"> <text>Increase participants' self-management capabilities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The health home shall ensure that all communication shared with the participant, the participant's family, and caregivers is language, literacy, and culturally appropriate.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral to Community and Social Support Services. The health home shall provide assistance in accessing and coordinating, as appropriate:</text> <paragraph num="(1)"> <text>Medical assistance;</text> </paragraph> <paragraph num="(2)"> <text>Disability benefits;</text> </paragraph> <paragraph num="(3)"> <text>Subsidized or supported housing;</text> </paragraph> <paragraph num="(4)"> <text>Personal needs support;</text> </paragraph> <paragraph num="(5)"> <text>Peer support; or</text> </paragraph> <paragraph num="(6)"> <text>Legal services.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The health home shall assist in coordinating these services.</text> </paragraph> <paragraph num="H."> <text>Use of HIT to Link Services. The provider shall use HIT, including CRISP and the ASO system to:</text> <paragraph num="(1)"> <text>Facilitate communication between health home staff members, the participant, and their caregivers; and</text> </paragraph> <paragraph num="(2)"> <text>As appropriate, provide feedback to participants' other providers.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Health home services provided by PRP, MTS, or OTP staff qualify as covered services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Health Home Participant Flow."> <paragraph num="A."> <text>Enrollment.</text> <paragraph num="(1)"> <text>The health home shall enroll an individual only after the individual has been enrolled in the health home provider's applicable PRP, MTS, or OTP services.</text> </paragraph> <paragraph num="(2)"> <text>During enrollment, an OTP established as a health home shall identify eligible individuals under the OTP’s care and report the diagnoses related to qualifying risk factors set forth in Regulation .03A(2)(b) of this chapter in the ASO system.</text> </paragraph> <paragraph num="(3)"> <text>The health home shall provide the individual with a brief description of health home services, including:</text> <paragraph num="(a)"> <text>Explaining the data-sharing elements of the program; and</text> </paragraph> <paragraph num="(b)"> <text>Describing how the individual may opt out if desired.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Following the provision of information in accordance with §A(3) of this regulation, the health home shall obtain the individual's consent to participate in the health home.</text> </paragraph> <paragraph num="(5)"> <text>Following consent to participate in accordance with §A(4) of this regulation, the health home shall complete the individual's online intake report through the ASO system thereby enrolling the individual into the health home.</text> </paragraph> <paragraph num="(6)"> <text>The health home shall:</text> <paragraph num="(a)"> <text>Notify a participant's other treatment providers about health home services; and</text> </paragraph> <paragraph num="(b)"> <text>Encourage other providers' participation in care coordination efforts.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Participation.</text> <paragraph num="(1)"> <text>A health home participant shall receive a minimum of two health home services per month, as defined in Regulation .06 of this chapter and to be documented in the ASO system.</text> </paragraph> <paragraph num="(2)"> <text>An assigned health home care manager shall monitor the participant's care and health status and coordinate with other staff to provide appropriate health home services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Discharge.</text> <paragraph num="(1)"> <text>In the event of discharge, the health home shall create a discharge plan that includes referrals to appropriate services and providers.</text> </paragraph> <paragraph num="(2)"> <text>The health home shall report all discharges and completion of discharge plans in the ASO system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Limitations."> <paragraph num="A."> <text>An eligible individual may not receive services from a health home provider that is not the individual’s PRP, MTS, or OTP provider.</text> </paragraph> <paragraph num="B."> <text>Health home services do not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a participant to select from all available services for which the participant is found to be eligible; or</text> </paragraph> <paragraph num="(3)"> <text>A participant’s free choice among providers in the Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may not reimburse the health home provider for:</text> <paragraph num="(1)"> <text>Activities that have already been billed to or counted towards a service requirement for another Medical Assistance Program or other program;</text> </paragraph> <paragraph num="(2)"> <text>Activities not consistent with the definition of health home services under this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Activities delivered as part of institutional discharge planning that are not comprehensive transitional care services delivered by the health home;</text> </paragraph> <paragraph num="(4)"> <text>A participant’s health home monthly rate more than once per month;</text> </paragraph> <paragraph num="(5)"> <text>A participant’s health home monthly rate when the intake encounter is utilized by the provider as one of the two required monthly service encounters;</text> </paragraph> <paragraph num="(6)"> <text>A participant’s health home monthly rate when the provider counts two encounters as having the same date of service, unless:</text> <paragraph num="(a)"> <text>The modality of the two encounters is different because one was an individual encounter and one was a group encounter; or</text> </paragraph> <paragraph num="(b)"> <text>The encounters are distinguishable by both the time at which they were rendered and the subject matter discussed; or</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The health home monthly rate when the two required services were both rendered as group services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may not reimburse for monthly health home services unless the individual receiving health home services:</text> <paragraph num="(1)"> <text>Is Medicaid eligible at the time of service delivery and engaged in treatment or rehabilitation with either OTP or PRP or MTS services;</text> </paragraph> <paragraph num="(2)"> <text>Is enrolled as a health home member at the billing health home provider; and</text> </paragraph> <paragraph num="(3)"> <text>Has received a minimum of two health home services in the stated month that has been documented in the ASO system.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement will not be made for health home services if the participant is receiving a comparable service under another Medical Assistance Program or other program.</text> </paragraph> <paragraph num="F."> <text>A participant’s health home provider may not be the participant’s family member.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>The Department shall reimburse the health home for covered services according to the requirements in this chapter and the rate established in §C of this regulation.</text> </paragraph> <paragraph num="B."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>The health home provider is authorized to bill for the intake and ongoing monthly rate for a participant when:</text> <paragraph num="(a)"> <text>The participant is receiving PRP, MTS, or OTP services; and</text> </paragraph> <paragraph num="(b)"> <text>The intake portion of the participant's ASO system file has been submitted and initial services have been delivered.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After completing the required health home service provision reporting in the ASO system, the health home provider shall, within 30 days from the end of the month during which health home services were provided, submit a request for payment for all participants who received two health home services during that month.</text> </paragraph> <paragraph num="(3)"> <text>A health home provider shall bill the Department for the appropriate rate specified in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall reimburse according to the following fee schedule:</text> <paragraph num="(1)"> <text>For dates of service from July 1, 2023 through December 31, 2023, at a monthly rate of $131.03 per participant;</text> </paragraph> <paragraph num="(2)"> <text>For dates of service from January 1, 2024 through June 30, 2024, at a monthly rate of $141.51; and</text> </paragraph> <paragraph num="(3)"> <text>For dates of service beginning July 1, 2024, at a monthly rate of $145.76.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal from the Medical Assistance Program and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>If the Department determines that a health home provider has failed to comply with the provisions of this chapter, the Department may initiate one or more of the following actions against the health home provider:</text> <paragraph num="(1)"> <text>Recovery of overpayment made by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Reduction in payment by the Department, including a 10 percent reduction in reimbursement for services that are not billed within the time frame required by Regulation .09B(2) of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Suspension from being a health home provider;</text> </paragraph> <paragraph num="(5)"> <text>Removal from being a health home provider; or</text> </paragraph> <paragraph num="(6)"> <text>Disqualification from being a health home provider at any future time.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeal Procedures."> <text>Appeal procedures shall be as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c), 15-103, and 15-105(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 30, 2013 (40:19 Md. R. 1544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 7, 2014 (41:13 Md. R. 752); November 13, 2023 (50:22 Md. R. 973); May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 24, 2014 (41:23 Md. R. 1372)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04P amended effective May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, H amended effective May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective April 4, 2022 (49:7 Md. R. 465), May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 4, 2022 (49:7 Md. R. 465)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 11, 2026 (53:9 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective October 24, 2016 (43:21 Md. R. 1166); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164); November 13, 2023 (50:22 Md. R. 973); September 16, 2024 (51:18 Md. R. 808); November 10, 2025 (52:22 Md. R. 1095)</annotation> </annotations> </chapter> <chapter num="34" heading="Therapeutic Behavioral Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Behavioral plan” means an individualized written plan for therapeutic behavioral services which includes the components specified in Regulation .03B(1) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396(a)—(v).</text> </paragraph> <paragraph num="(3)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) provider” means any health care provider acting within the scope of the provider's practice who:</text> <paragraph num="(a)"> <text>Screens, evaluates, or identifies a condition; and</text> </paragraph> <paragraph num="(b)"> <text>Recommends treatment.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(6)"> <text>“Preauthorization” means the approval required from the Department, or its designee, before services may be rendered.</text> </paragraph> <paragraph num="(7)"> <text>“Prescribed” means ordered in writing and signed by an EPSDT provider who has examined the participant and diagnosed the [recipient's] participant’s medical condition.</text> </paragraph> <paragraph num="(8)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(9)"> <text>“Rehabilitative service” means a medical or remedial service prescribed by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland, or the jurisdiction where services are rendered for:</text> <paragraph num="(a)"> <text>Maximum reduction of physical or mental disability; and</text> </paragraph> <paragraph num="(b)"> <text>Restoration of a participant’s best possible functional level.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Therapeutic behavioral aide” means an individual who is:</text> <paragraph num="(a)"> <text>A health care professional or a nonprofessional who is supervised by an individual who is licensed, certified, or otherwise legally authorized to provide mental health services independently in the state where the service is rendered;</text> </paragraph> <paragraph num="(b)"> <text>Trained and supervised by a therapeutic behavioral service provider to implement a behavior plan; and</text> </paragraph> <paragraph num="(c)"> <text>Available on-site to provide one-to-one behavioral assistance and intervention to accomplish outcomes specified in the behavioral plan.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Therapeutic behavioral assessment” means a comprehensive assessment of a participant and, if applicable, a participant’s family that:</text> <paragraph num="(a)"> <text>Is performed by a licensed or certified health care professional;</text> </paragraph> <paragraph num="(b)"> <text>Addresses the medical and behavioral needs for therapeutic behavioral services;</text> </paragraph> <paragraph num="(c)"> <text>Includes the risk of needing placement in a more restrictive living arrangement because of the behavior; and</text> </paragraph> <paragraph num="(d)"> <text>Includes development of a behavioral plan.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Therapeutic behavioral service” means an intensive, rehabilitative service that is documented in the written behavioral plan and is intended to:</text> <paragraph num="(a)"> <text>Provide the participant with behavioral management skills to effectively manage the behaviors or symptoms that place the participant at risk for a higher level of care; and</text> </paragraph> <paragraph num="(b)"> <text>Restore the participant’s previously acquired behavior skills and enable the participant to develop appropriate behavior management skills.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Therapeutic behavioral service provider” means:</text> <paragraph num="(a)"> <text>A Developmental Disabilities Administration provider meeting criteria set forth in COMAR 10.22.02;</text> </paragraph> <paragraph num="(b)"> <text>An outpatient mental health clinic approved under COMAR 10.21.20;</text> </paragraph> <paragraph num="(c)"> <text>A mental health mobile treatment unit meeting criteria set forth in COMAR 10.09.59; or</text> </paragraph> <paragraph num="(d)"> <text>A psychiatric rehabilitation program approved under COMAR 10.21.29.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Conditions for Provider Participation."> <paragraph num="A."> <text>A therapeutic behavioral service provider shall:</text> <paragraph num="(1)"> <text>Ensure that therapeutic behavioral aides are trained and supervised in:</text> <paragraph num="(a)"> <text>Principles of behavior change and childhood development;</text> </paragraph> <paragraph num="(b)"> <text>Clinically accepted techniques for decreasing or eliminating maladaptive behaviors;</text> </paragraph> <paragraph num="(c)"> <text>Implementing a behavioral plan;</text> </paragraph> <paragraph num="(d)"> <text>Identifying the needs and characteristics of the participant; and</text> </paragraph> <paragraph num="(e)"> <text>Documenting interventions and outcomes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the therapeutic aide is not licensed or certified by a health practice licensure board to practice independently, ensure that a licensed healthcare practitioner shall:</text> <paragraph num="(a)"> <text>Meet at least once every 2 weeks with the aide and review the progress and develop a plan of care for each participant assigned to the aide; and</text> </paragraph> <paragraph num="(b)"> <text>At least once a month, observe the participant’s progress and needs with the participant’s parent or guardian; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide a written progress note that is completed for each time period that a therapeutic behavioral aide spends with the participant and includes:</text> <paragraph num="(a)"> <text>The location, date, start time, and end time of the service;</text> </paragraph> <paragraph num="(b)"> <text>The name of the parent, guardian, or individual who customarily provides care present during the service;</text> </paragraph> <paragraph num="(c)"> <text>A brief description of the service provided, including reference to the behavioral plan;</text> </paragraph> <paragraph num="(d)"> <text>A description of the participant’s behaviors or symptoms; and</text> </paragraph> <paragraph num="(e)"> <text>The signature of the behavioral aide.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>General requirements for provider participation in the Program are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in this chapter when the services are:</text> <paragraph num="(1)"> <text>Diagnosed, identified, and prescribed by an EPSDT provider to be medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Preauthorized by the Department or its designee; and</text> </paragraph> <paragraph num="(3)"> <text>Delivered in accordance with the behavioral plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following services are covered:</text> <paragraph num="(1)"> <text>Therapeutic behavioral assessment and reassessment that includes:</text> <paragraph num="(a)"> <text>Development of a behavioral plan with the participant and parent, guardian, or individual who customarily provides care which specifically:</text> <paragraph num="(i)"> <text>Identifies the target behaviors or symptoms that are placing the current living arrangement at risk or presenting a barrier to transition to a less restrictive living arrangement;</text> </paragraph> <paragraph num="(ii)"> <text>Defines specific interventions to be used to resolve the behaviors or symptoms, including how a therapeutic aide will implement therapeutic behavioral services;</text> </paragraph> <paragraph num="(iii)"> <text>Defines outcome measures that can be used to demonstrate the decreasing frequency of targeted behaviors;</text> </paragraph> <paragraph num="(iv)"> <text>Defines alternative behaviors;</text> </paragraph> <paragraph num="(v)"> <text>Defines the clinically accepted techniques for behavior change, including where, when, and the frequency of the techniques to be used and the risks and benefits of each;</text> </paragraph> <paragraph num="(vi)"> <text>Details the strategies and skills for the participant and parent, guardian, or individual who customarily provides cares to provide continuity of care when therapeutic behavioral services are discontinued;</text> </paragraph> <paragraph num="(vii)"> <text>Details emergency procedures to be implemented when the participant exhibits behaviors that pose harm to self or others;</text> </paragraph> <paragraph num="(viii)"> <text>Contains written informed consent before implementation, of the parent or legal guardian, or if the participant is 18 years old or older, written informed consent of the participant; and</text> </paragraph> <paragraph num="(ix)"> <text>Identifies the level or type of licensed healthcare professional responsible for monitoring the behavioral plan; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Determination if therapeutic behavioral services are needed;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Therapeutic behavioral services that:</text> <paragraph num="(a)"> <text>Provide one-to-one intervention for a specified period of time at the appropriate site in accordance with the behavioral plan; and</text> </paragraph> <paragraph num="(b)"> <text>May include, but are not limited to:</text> <paragraph num="(i)"> <text>Assisting the participant to engage in or remain engaged in appropriate activities;</text> </paragraph> <paragraph num="(ii)"> <text>Minimizing the participant’s impulsive behavior;</text> </paragraph> <paragraph num="(iii)"> <text>Providing immediate behavioral reinforcements;</text> </paragraph> <paragraph num="(iv)"> <text>Providing time structuring activities; and</text> </paragraph> <paragraph num="(v)"> <text>Collaboration with and support for parent, guardian, or individual who customarily provides care in the effort to provide ongoing behavioral support.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Limitations."> <paragraph num="A."> <text>To be eligible for therapeutic behavioral services the:</text> <paragraph num="(1)"> <text>Participant shall be younger than 21 years old and enrolled in the Program;</text> </paragraph> <paragraph num="(2)"> <text>Participant shall be assessed as having behaviors or symptoms related to a mental health diagnosis that places the individual's current living arrangement at risk and creates a risk for a more restrictive placement, or prevents transition to a less restrictive placement;</text> </paragraph> <paragraph num="(3)"> <text>Participant’s behaviors or symptoms shall be safely and effectively treated in the community; and</text> </paragraph> <paragraph num="(4)"> <text>Participant’s parent, guardian, or individual who customarily provides care shall be present during the provision of all therapeutic behavioral services to participate in the behavioral plan, unless there are clinical goals specifically addressed in the behavior plan that need to be achieved requiring that the parent, guardian, or individual who customarily provides care not be present.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Therapeutic behavioral services shall meet the definition of rehabilitation services.</text> </paragraph> <paragraph num="C."> <text>Therapeutic behavioral services shall be:</text> <paragraph num="(1)"> <text>Decreased proportionally when indicated by the participant’s progress;</text> </paragraph> <paragraph num="(2)"> <text>Discontinued when the targeted outcomes have been reached; or</text> </paragraph> <paragraph num="(3)"> <text>Reassessed for new targeted outcomes if progress on the current outcomes is not being achieved.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A therapeutic behavioral service provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Services that are:</text> <paragraph num="(a)"> <text>Provided in:</text> <paragraph num="(i)"> <text>An intermediate care facility;</text> </paragraph> <paragraph num="(ii)"> <text>An institution for mental disease;</text> </paragraph> <paragraph num="(iii)"> <text>A hospital; or</text> </paragraph> <paragraph num="(iv)"> <text>A crisis residential program;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Habilitative, custodial, or activities of daily living;</text> </paragraph> <paragraph num="(c)"> <text>Not authorized by the Department or its designee;</text> </paragraph> <paragraph num="(d)"> <text>Provided by a therapeutic behavioral aide who is a member of the participant’s immediate family or who resides in the participant’s home;</text> </paragraph> <paragraph num="(e)"> <text>Not medically necessary;</text> </paragraph> <paragraph num="(f)"> <text>Beyond the provider's scope of practice;</text> </paragraph> <paragraph num="(g)"> <text>Not performed under the supervision of a licensed health care provider;</text> </paragraph> <paragraph num="(h)"> <text>Rendered but not appropriately documented;</text> </paragraph> <paragraph num="(i)"> <text>Part of another service paid for by the State; or</text> </paragraph> <paragraph num="(j)"> <text>Rendered by mail, telephone, or otherwise not one-to-one, in person;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services that duplicate the care and custody provided by another State agency pursuant to a court order or a voluntary placement agreement;</text> </paragraph> <paragraph num="(3)"> <text>Respite services;</text> </paragraph> <paragraph num="(4)"> <text>Seclusion or restrictive techniques;</text> </paragraph> <paragraph num="(5)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(6)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(7)"> <text>Travel to and from site of service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Preauthorization."> <paragraph num="A."> <text>The Department or its designee shall require preauthorization for therapeutic behavioral services.</text> </paragraph> <paragraph num="B."> <text>The initial authorization shall be given for not more than 60 calendar days.</text> </paragraph> <paragraph num="C."> <text>Additional authorization beyond the initial authorization shall be requested at a minimum, every 60 days and in advance of the expiration of the previous authorization.</text> </paragraph> <paragraph num="D."> <text>Authorization may only be given if the therapeutic behavioral service continues to be effective and progress towards the specified goals is documented.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Reimbursement for services covered under this chapter is as follows:</text> <paragraph num="(1)"> <text>For dates of service from November 1, 2021 through June 30, 2022:</text> <paragraph num="(a)"> <text>Initial therapeutic assessment and reassessment at a rate of $136.12; and</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic behavioral services at a rate of:</text> <paragraph num="(i)"> <text>$29.50 for the first 30 minutes; and</text> </paragraph> <paragraph num="(ii)"> <text>$14.75 for each additional 15 minutes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2022:</text> <paragraph num="(a)"> <text>Initial therapeutic assessment and reassessment at a rate of $145.99; and</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic behavioral services at a rate of:</text> <paragraph num="(i)"> <text>$31.64 for the first 30 minutes; and</text> </paragraph> <paragraph num="(ii)"> <text>$15.82 for each additional 15 minutes.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>This chapter shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 24, 2005 (32:23 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 2, 2011 (38:9 Md. R. 552); December 12, 2022 (49:25 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 12, 2022 (49:25 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050); August 21, 2023 (50:16 Md. R. 726)</annotation> </annotations> </chapter> <chapter num="35" heading="Hospice Care"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Attending physician” means:</text> <paragraph num="(a)"> <text>A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State; or</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner who meets the qualifications set forth in COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Bereavement counseling” means counseling services provided to the participant's family after the participant's death.</text> </paragraph> <paragraph num="(3)"> <text>“Cap period” means the 12-month period beginning November 1 of each year and ending October 31 of the following year, which is used in the annual application of the limitation on reimbursement at the general inpatient and inpatient respite care rates.</text> </paragraph> <paragraph num="(4)"> <text>“Core services” means the hospice services that must routinely be provided directly by hospice employees, that is, nursing care, physician services, medical social services, and counseling.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Department as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(6)"> <text>“Election period” means a period for which a recipient may elect to receive hospice care in accordance with Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>“Health Maintenance Organization (HMO)” means an organization which has contracted with the Department to deliver specific health care services to recipients in accordance with COMAR 10.09.16.</text> </paragraph> <paragraph num="(8)"> <text>“Home” means that place of residence occupied by a participant. For purposes of hospice care, home may include a nursing facility.</text> </paragraph> <paragraph num="(9)"> <text>“Hospice” means a public agency or private organization or subdivision of either of these that:</text> <paragraph num="(a)"> <text>Is primarily engaged in providing care to terminally ill individuals;</text> </paragraph> <paragraph num="(b)"> <text>Meets all applicable State and local licensing and regulatory requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Is participating in Medicare as a hospice care provider.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Hospice nurse practitioner” means a nurse practitioner who:</text> <paragraph num="(a)"> <text>Is an employee of the hospice; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the qualifications set forth in COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Hospice physician” means a doctor of medicine or osteopathy who is:</text> <paragraph num="(a)"> <text>Employed by or contracted by the hospice; and</text> </paragraph> <paragraph num="(b)"> <text>Legally authorized to practice medicine and surgery by the State.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Hospital” means an institution which is participating in Medicare or in a Medical Assistance Program as a hospital.</text> </paragraph> <paragraph num="(13)"> <text>“Interdisciplinary group” means a group of provider employees who provide or supervise hospice care, and include at least a:</text> <paragraph num="(a)"> <text>Doctor of medicine or osteopathy;</text> </paragraph> <paragraph num="(b)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>Social worker; and</text> </paragraph> <paragraph num="(d)"> <text>Pastoral or other counselor.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons, jointly financed by the federal and State governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(16)"> <text>“Medicare” means Medicare as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(17)"> <text>“Nursing facility” means a facility or a distinct part of a facility which is participating in a Medical Assistance Program as a nursing facility provider.</text> </paragraph> <paragraph num="(18)"> <text>“Participant” means a recipient who is eligible, has elected, and is receiving hospice care in accordance with the provisions of this chapter.</text> </paragraph> <paragraph num="(19)"> <text>“Plan of care” means a written, individualized care plan established and maintained for each recipient enrolled by a hospice provider.</text> </paragraph> <paragraph num="(20)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(21)"> <text>“Provider” means a hospice that meets the requirements of Regulation .03 of this chapter and which, through a provider agreement signed with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(22)"> <text>“Provider agreement” means a contract between the Department and the provider.</text> </paragraph> <paragraph num="(23)"> <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(24)"> <text>“Representative” means a person who is, because of the recipient's mental or physical incapacity, authorized, in accordance with the State law to execute or revoke an election for hospice care, to advise concerning the plan of care, or to terminate medical care on behalf of the terminally ill individual.</text> </paragraph> <paragraph num="(25)"> <text>“Respite care” means short-term care furnished to a participant for the purpose of providing rest or relief for family members or other individuals routinely furnishing at-home care to the participant.</text> </paragraph> <paragraph num="(26)"> <text>“Room and board” means services provided to a participant who is a nursing facility resident.</text> </paragraph> <paragraph num="(27)"> <text>“Skilled nursing facility” means a nursing facility or a distinct part of a nursing facility which is participating in Medicare as a skilled nursing facility.</text> </paragraph> <paragraph num="(28)"> <text>“Terminally ill” means that the individual has a medical prognosis of a life expectancy of 6 months or less if the illness runs its normal course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>In order to participate in the Program, a provider shall be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, or shall be legally authorized to provide hospice care in the jurisdiction in which the services are provided, and shall obtain other licenses as may be required by applicable State and local laws.</text> </paragraph> <paragraph num="B."> <text>Employees of the provider who provide hospice care services must be licensed, certified, or registered in accordance with applicable federal, State, and local laws.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions of Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that providers shall:</text> <paragraph num="(1)"> <text>Meet all conditions for participation as set forth in COMAR 10.09.36.03, except as otherwise specified in this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the licensure requirements as provided in Regulation .02 of this chapter are met.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a hospice care provider are that the provider shall:</text> <paragraph num="(1)"> <text>Meet the requirements of §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Be a participating Medicare hospice.</text> </paragraph> <paragraph num="(3)"> <text>Provide information about a participant's election, continuation, and termination of hospice care in accordance with procedures established by the Program.</text> </paragraph> <paragraph num="(4)"> <text>Provide directly or make available through arrangements the covered services in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>Make nursing services, physician services, and drugs and biologicals routinely available on a 24-hour basis.</text> </paragraph> <paragraph num="(6)"> <text>Make all other covered services available on a 24-hour basis to the extent necessary to meet a participant's needs for care as specified in the participant's plan of care.</text> </paragraph> <paragraph num="(7)"> <text>Have a written policy, approved by the Program, which assures that the release of information from the participant's record is handled in accordance with applicable State and federal laws and regulations governing confidentiality.</text> </paragraph> <paragraph num="(8)"> <text>Ensure that all core services are routinely provided directly by the provider's employees. Volunteers under the jurisdiction of the provider are considered provider employees. Contracted staff may be used to supplement employees only when necessary during periods of peak patient loads, under extraordinary circumstances, or to obtain physician specialty services.</text> </paragraph> <paragraph num="(9)"> <text>Provide bereavement counseling, even though it is not a reimbursable service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Duration of Hospice Care."> <paragraph num="A."> <text>An individual may elect to receive hospice care during one or more of the following election periods:</text> <paragraph num="(1)"> <text>An initial 90-day period;</text> </paragraph> <paragraph num="(2)"> <text>A subsequent 90-day period; or</text> </paragraph> <paragraph num="(3)"> <text>An unlimited number of subsequent 60-day periods.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The periods of care indicated in §A of this regulation are available in the order listed and may be elected separately at different times.</text> </paragraph> <paragraph num="C."> <text>An election period or an extended election period shall terminate before expiration when one of the following conditions is met:</text> <paragraph num="(1)"> <text>The participant dies;</text> </paragraph> <paragraph num="(2)"> <text>The election of hospice care is revoked in accordance with Regulation .05D of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>The participant's eligibility for Medical Assistance is cancelled;</text> </paragraph> <paragraph num="(4)"> <text>The Program determines that the election period or extended election period shall be terminated for cause. Cause for termination may include, but shall not be limited to:</text> <paragraph num="(a)"> <text>A change in the participant's prognosis as being terminally ill;</text> </paragraph> <paragraph num="(b)"> <text>Relocation by the participant to a place of residence where a hospice care provider is not available; or</text> </paragraph> <paragraph num="(c)"> <text>Action or behavior of the participant that makes continuation of hospice care inappropriate, such as misconduct, fraud, or repeated instances of willfully and knowingly seeking services related to the terminal illness from other than the designated provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>When a participant revokes the election of hospice care, in accordance with Regulation .05D of this chapter, during an election period, any remaining days in that election period shall be forfeited. Thereafter, the participant may elect hospice coverage for any remaining election periods for which the participant is eligible.</text> </paragraph> <paragraph num="E."> <text>When a participant revokes the election of hospice care during an extended election period, further Program coverage of hospice care shall be forfeited.</text> </paragraph> <paragraph num="F."> <text>The waiver of rights to Program payments described in Regulation .05B(5) of this chapter shall expire as of the effective date of termination of the election period or extended election period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility for and Election of Hospice Care."> <paragraph num="A."> <text>To be eligible for hospice care, written certification of terminal illness shall be obtained by the hospice for each of the election periods listed in Regulation .04 of this chapter. Procedures for certification of terminal illness are as follows:</text> <paragraph num="(1)"> <text>The hospice shall obtain the written certification before the hospice submits a claim for payment;</text> </paragraph> <paragraph num="(2)"> <text>If the hospice is unable to obtain written certification within 2 calendar days after an election period begins, an oral certification shall be obtained within 2 calendar days and a written certification shall be obtained before the hospice submits a claim for payment;</text> </paragraph> <paragraph num="(3)"> <text>Certifications shall be completed not more than 15 calendar days before the start of the election period;</text> </paragraph> <paragraph num="(4)"> <text>For the initial election period, the hospice shall obtain written certification statements and shall document oral certification statements in accordance with §A(2) of this regulation from:</text> <paragraph num="(a)"> <text>The medical director of the hospice or the physician member of the hospice interdisciplinary team; and</text> </paragraph> <paragraph num="(b)"> <text>The attending physician, if there is an attending physician;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For subsequent election periods, certification by one of the physicians listed in §A(4) of this regulation is required;</text> </paragraph> <paragraph num="(6)"> <text>All certifications shall:</text> <paragraph num="(a)"> <text>Be signed and dated by the certifying physician; and</text> </paragraph> <paragraph num="(b)"> <text>Include the date of the election for which the certification applies;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Certifications shall be based on the certifying physician’s clinical judgment regarding the normal course of the recipient’s illness and conform to the following requirements:</text> <paragraph num="(a)"> <text>Document that the participant’s prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course;</text> </paragraph> <paragraph num="(b)"> <text>Clinical information documenting the prognosis of a terminal illness shall accompany the certification and shall be filed in the medical record;</text> </paragraph> <paragraph num="(c)"> <text>Clinical information for the initial election period may be provided orally and shall be documented in the medical record and included as part of the hospice’s eligibility assessment;</text> </paragraph> <paragraph num="(d)"> <text>A brief narrative written by the certifying physician:</text> <paragraph num="(i)"> <text>Shall be included in the certification;</text> </paragraph> <paragraph num="(ii)"> <text>Shall be located immediately before the certifying physician’s signature or included as an addendum signed by the certifying physician;</text> </paragraph> <paragraph num="(iii)"> <text>Shall include a statement inserted directly above the certifying physician’s signature and based on a review of the participant’s medical record or examination of the participant;</text> </paragraph> <paragraph num="(iv)"> <text>Shall reflect the participant’s individual clinical circumstances; and</text> </paragraph> <paragraph num="(v)"> <text>May not contain checkboxes or standard language used for all participants;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>To determine continued eligibility for hospice care, a face-to-face encounter by the hospice physician or the hospice nurse practitioner shall occur:</text> <paragraph num="(a)"> <text>When a stay across all hospices is anticipated to reach the third election period; and</text> </paragraph> <paragraph num="(b)"> <text>Not more than 30 days before the third election period and any subsequent election period; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A narrative associated with an election period requiring a face-to-face encounter shall include:</text> <paragraph num="(a)"> <text>An explanation of why the clinical findings support a prognosis of a terminal illness; and</text> </paragraph> <paragraph num="(b)"> <text>A written attestation of the date of the encounter and that the clinical findings were provided to the certifying physician.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A recipient 21 years old or older meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following:</text> <paragraph num="(1)"> <text>A statement that the recipient or the representative elects hospice care for the recipient;</text> </paragraph> <paragraph num="(2)"> <text>Identification of the provider that will furnish hospice care to the recipient;</text> </paragraph> <paragraph num="(3)"> <text>The effective date of the election, which may not be earlier than the date that the election is made;</text> </paragraph> <paragraph num="(4)"> <text>A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative rather than curative nature as it relates to the recipient's terminal illness and related conditions;</text> </paragraph> <paragraph num="(5)"> <text>A statement that the recipient or representative understands that the recipient waives all rights to Program payments for the duration of the election of hospice care for the following services:</text> <paragraph num="(a)"> <text>Hospice care provided by a hospice other than the provider designated by the recipient or representative, unless provided under arrangements made by the designated provider; and</text> </paragraph> <paragraph num="(b)"> <text>Any services covered by the Program that are related to treatment of the terminal condition or a related condition, or that are equivalent to hospice care, except for services provided by:</text> <paragraph num="(i)"> <text>The designated provider;</text> </paragraph> <paragraph num="(ii)"> <text>Another hospice under arrangements made by the designated provider;</text> </paragraph> <paragraph num="(iii)"> <text>The recipient's attending physician if that physician is not an employee of the designated provider or receiving compensation from the provider for those services; or</text> </paragraph> <paragraph num="(iv)"> <text>A nursing facility as room and board, if the recipient is a resident of a nursing facility and would be eligible under the Program for nursing facility services if hospice care was not elected; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>The signature of the recipient or representative.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A recipient younger than 21 years old meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following:</text> <paragraph num="(1)"> <text>A statement that the recipient or the representative elects hospice care for the recipient;</text> </paragraph> <paragraph num="(2)"> <text>Identification of the provider that will furnish hospice care to the recipient;</text> </paragraph> <paragraph num="(3)"> <text>The effective date of the election, which may not be earlier than the date that the election is made;</text> </paragraph> <paragraph num="(4)"> <text>A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative nature as it relates to the recipient's terminal illness and related conditions;</text> </paragraph> <paragraph num="(5)"> <text>A statement that the recipient or representative understands that hospice services shall be made available without forgoing Program payments for curative treatment for the terminal illness; and</text> </paragraph> <paragraph num="(6)"> <text>The signature of the recipient or representative.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The election of hospice care shall be considered to continue uninterrupted through the first election period and through any subsequent election periods and any extended election periods, as long as the participant:</text> <paragraph num="(1)"> <text>Remains in the care of a provider; and</text> </paragraph> <paragraph num="(2)"> <text>Does not have the hospice care terminated under the provisions of Regulation .04D of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The election of hospice care may be revoked by the participant or representative at any time for any reason during an election period or an extended election period. Revocation requires the following:</text> <paragraph num="(1)"> <text>The participant or representative shall file a statement with the provider that includes the following information:</text> <paragraph num="(a)"> <text>A statement that the participant or representative revokes the election of Program coverage of hospice care and understands that the participant forfeits the remaining days in the election period;</text> </paragraph> <paragraph num="(b)"> <text>The date that the revocation is to be effective, which may not be earlier than the date the revocation is made; and</text> </paragraph> <paragraph num="(c)"> <text>The signature of the participant or representative.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>As of the effective date of the revocation of the election of hospice care, the recipient:</text> <paragraph num="(a)"> <text>Is no longer covered under the Program for hospice care;</text> </paragraph> <paragraph num="(b)"> <text>Resumes Program coverage of services waived under §B(5) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Forfeits Program coverage of hospice care for any days remaining in the election period, but may at a future time elect hospice care for any remaining election period for which the recipient is eligible.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A participant may designate a new provider of hospice care not more than once during an election period. Designation shall be as follows:</text> <paragraph num="(1)"> <text>The designation of a new provider is not a revocation of the election of hospice care under §D of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>To designate a new provider, the participant or representative shall file with the previously designated provider and with the newly designated provider, a statement that includes the following information:</text> <paragraph num="(a)"> <text>The names of the previously designated provider and the new provider;</text> </paragraph> <paragraph num="(b)"> <text>The effective date of the change of providers; and</text> </paragraph> <paragraph num="(c)"> <text>The signature of the participant or representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A change in ownership of the provider is not considered a change in the participant's designation of a provider and requires no action on the participant's part.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The provider shall maintain the statements described in this regulation and provide copies or related information to the Program on request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>Hospice care includes the services listed in §B of this regulation when the services are:</text> <paragraph num="(1)"> <text>Provided to an eligible recipient who elects hospice care, in accordance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Reasonable and necessary for the palliation or management of the participant's terminal illness and related conditions;</text> </paragraph> <paragraph num="(3)"> <text>Consistent with the plan of care established before the services are provided;</text> </paragraph> <paragraph num="(4)"> <text>Provided by appropriately qualified personnel;</text> </paragraph> <paragraph num="(5)"> <text>Administered according to accepted standards of practice; and</text> </paragraph> <paragraph num="(6)"> <text>Routinely provided directly by provider employees, when they are the core services listed in §B(1)—(4) of this regulation, except that the provider may contract for supplemental services during peak patient loads, under extraordinary circumstances, or to obtain physician specialty services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following are covered hospice care services:</text> <paragraph num="(1)"> <text>Nursing care provided by a nurse licensed as a registered nurse in the jurisdiction in which services are provided or by an individual under the supervision of a registered nurse;</text> </paragraph> <paragraph num="(2)"> <text>Medical social services provided by a social worker who is:</text> <paragraph num="(a)"> <text>In compliance with the social work licensing requirements of the jurisdiction in which service is provided; and</text> </paragraph> <paragraph num="(b)"> <text>Working under the direction of a physician;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physician services performed by a physician as described in 42 CFR §§410.20—410.25, except that the services of the provider's medical director or physician member of the interdisciplinary group shall be performed by a doctor of medicine or osteopathy;</text> </paragraph> <paragraph num="(4)"> <text>Counseling services provided to the participant and the family members or other persons caring for the participant at home, including:</text> <paragraph num="(a)"> <text>Dietary counseling;</text> </paragraph> <paragraph num="(b)"> <text>Counseling to train the participant's family or other caregivers in providing care;</text> </paragraph> <paragraph num="(c)"> <text>Spiritual counseling to help the participant and the family or other caregivers in the home to adjust to the participant's approaching death;</text> </paragraph> <paragraph num="(d)"> <text>Bereavement counseling for the family after the participant's death; and</text> </paragraph> <paragraph num="(e)"> <text>Additional counseling provided by interdisciplinary group members, as well as by other qualified professionals as necessary;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Short-term inpatient care subject to the following conditions:</text> <paragraph num="(a)"> <text>General inpatient care may be provided to meet the participant's needs for pain control or for acute or chronic symptom management that cannot be met in other settings;</text> </paragraph> <paragraph num="(b)"> <text>Inpatient respite care may be furnished to provide rest or relief for family members or other individuals routinely furnishing at-home care to the participant; and</text> </paragraph> <paragraph num="(c)"> <text>General inpatient care and inpatient respite care shall be provided in a:</text> <paragraph num="(i)"> <text>Hospice that meets the conditions of participation for providing inpatient care directly as set forth in 42 CFR §418.100; or</text> </paragraph> <paragraph num="(ii)"> <text>Hospital, skilled nursing facility, or nursing facility that meets the special hospice standards regarding 24-hour nursing service and patient areas as set forth in 42 CFR §418.100(a) and (e);</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Medical appliances and supplies, including drugs and biologicals, which are needed for the palliation and management of the terminal illness and related conditions;</text> </paragraph> <paragraph num="(7)"> <text>Home health aide and homemaker services furnished by qualified individuals, who are under the general supervision of a registered nurse; and</text> </paragraph> <paragraph num="(8)"> <text>Physical therapy, occupational therapy, and speech-language pathology services provided by qualified individuals for purposes of symptom control or to enable the participant to maintain activities of daily living and basic functional skills.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <text>When a recipient is enrolled in Medicare Part A, Program payment for hospice care shall be limited to payment of the recipient's Medicare hospice care co-insurance amounts for drugs and biologicals and for respite care and, where applicable, room and board for residents of a nursing facility under Regulation .08E of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Program shall pay the provider at one of four rate categories for each day that the participant is under the provider's care, subject to the conditions, limitations, and exceptions set forth in this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The payment rates for providers shall be those established by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services for hospice care under a Medical Assistance Program.</text> </paragraph> <paragraph num="(3)"> <text>The daily rates are prospective rates, and there shall be no retroactive adjustment of payment other than the limitation on payment for inpatient care set forth in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Categories of Hospice Care for Reimbursement.</text> <paragraph num="(1)"> <text>Routine Home Care.</text> <paragraph num="(a)"> <text>The provider shall be paid the routine home care rate for each day the participant is under the care of the provider and another rate is not payable under §B(2)—(4) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>The routine home care rate is paid without regard to the volume or intensity of covered services provided on a given day.</text> </paragraph> <paragraph num="(c)"> <text>The routine home care rate is paid at one of the following levels, whichever is applicable:</text> <paragraph num="(i)"> <text>An enhanced rate for the first 60 days in which the participant is enrolled in hospice; or</text> </paragraph> <paragraph num="(ii)"> <text>A lesser rate for day 61 and thereafter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Continuous Home Care.</text> <paragraph num="(a)"> <text>The provider shall be paid the continuous home care rate for each day the participant is at home, under the care of the provider, and all of the following requirements are met:</text> <paragraph num="(i)"> <text>There is a brief period of crisis during which the participant requires continuous care, which is primarily nursing care to achieve palliation or management of acute medical symptoms.</text> </paragraph> <paragraph num="(ii)"> <text>Nursing care shall be provided by either a registered nurse or a licensed practical nurse, and a nurse must be providing care for more than half the period. Homemaker or home health aide services may be provided to supplement the nursing care.</text> </paragraph> <paragraph num="(iii)"> <text>A minimum of 8 hours of care must be provided during a 24-hour day which begins and ends at midnight, but the hours of care need not be continuous.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The continuous home care rate is divided by 24 hours to arrive at an hourly rate.</text> </paragraph> <paragraph num="(c)"> <text>For every hour or part of an hour of continuous home care furnished, the hourly rate shall be paid to the provider, up to 24 hours a day.</text> </paragraph> <paragraph num="(d)"> <text>If less skilled care is needed on a continuous basis to maintain the patient at home during a period of crisis, or if less than 8 hours of continuous home care is provided during a day, payment shall be made at the routine home care rate.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Inpatient Respite Care.</text> <paragraph num="(a)"> <text>The provider shall be paid the inpatient respite care rate for each day the participant is in a qualified inpatient facility for the purpose of respite care, subject to the following requirements:</text> <paragraph num="(i)"> <text>Payment shall be made at the inpatient respite care rate for a maximum of 5 consecutive days at a time, including the day of admission but not counting the day of discharge;</text> </paragraph> <paragraph num="(ii)"> <text>Payment for the sixth and any subsequent day of inpatient respite care shall be made at the routine home care rate;</text> </paragraph> <paragraph num="(iii)"> <text>For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and</text> </paragraph> <paragraph num="(iv)"> <text>Payment shall be made at the inpatient respite care rate for the day of discharge if the participant is discharged deceased.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Inpatient respite care may not be provided when the participant is a resident of a nursing facility.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>General Inpatient Care. The provider shall be paid the general inpatient care rate for each day the participant is in a qualified inpatient facility for care, subject to the following requirements:</text> <paragraph num="(a)"> <text>The inpatient care is required for procedures necessary for pain control or for acute or chronic symptom management which cannot be provided in other settings;</text> </paragraph> <paragraph num="(b)"> <text>Payment shall be made at the general inpatient rate for the day of admission and for all subsequent inpatient days, except for the day of discharge;</text> </paragraph> <paragraph num="(c)"> <text>For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and</text> </paragraph> <paragraph num="(d)"> <text>Payment shall be made at the general inpatient rate for the day of discharge if the participant is discharged deceased.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Limitation on Payment for Inpatient Care.</text> <paragraph num="(1)"> <text>Payment to a provider for inpatient care shall be limited according to the total number of days of inpatient care the provider furnished to participants during a specific cap period, excluding the days of inpatient care furnished to participants diagnosed with Acquired Immune Deficiency Syndrome (AIDS).</text> </paragraph> <paragraph num="(2)"> <text>For the cap period, the aggregate number of inpatient days reimbursed for general inpatient and inpatient respite care (excluding inpatient days reimbursed for participants with AIDS) may not exceed 20 percent of the aggregate total number of days of hospice care the provider furnished to all participants (excluding days of hospice care furnished to participants with AIDS) during the same period.</text> </paragraph> <paragraph num="(3)"> <text>The limitation on payment for inpatient care days is calculated as follows:</text> <paragraph num="(a)"> <text>Subtract the days of care furnished to participants with AIDS from the total days of care furnished by the provider to all participants during the cap period;</text> </paragraph> <paragraph num="(b)"> <text>Subtract the days of inpatient care furnished to participants with AIDS from the total days of inpatient care furnished by the provider to all participants during the cap period;</text> </paragraph> <paragraph num="(c)"> <text>The maximum allowable number of reimbursable inpatient days is determined by multiplying by 0.2 the adjusted total number of days of hospice care the provider furnished to participants during the cap period, as determined in §C(3)(a) of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>If the adjusted total number of inpatient care days the provider furnished to participants during the cap period, as determined in §C(3)(b) of this regulation, is less than or equal to the maximum allowable number of reimbursable inpatient days, no payment adjustment is necessary; and</text> </paragraph> <paragraph num="(e)"> <text>If the adjusted total number of inpatient care days the provider furnished to participants during the cap period exceeds the maximum allowable number of reimbursable inpatient days, the payment limitation and the refund to the Program shall be determined by:</text> <paragraph num="(i)"> <text>Calculating a ratio of the maximum allowable number of reimbursable inpatient days to the adjusted total number of inpatient care days, and multiplying this ratio by the total reimbursement to the provider during the cap period for general inpatient and inpatient respite care days (minus the reimbursement for inpatient care days furnished to participants with AIDS);</text> </paragraph> <paragraph num="(ii)"> <text>Multiplying excess inpatient care days by the routine home care rate;</text> </paragraph> <paragraph num="(iii)"> <text>Adding together the amounts calculated in §C(3)(e)(i) and (ii) of this regulation; and</text> </paragraph> <paragraph num="(iv)"> <text>Refunding to the Program the difference between the interim reimbursement made for non-AIDS inpatient care during the cap period and the amount determined in §C(3)(e)(iii) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>This limitation shall be applied once a year, at the end of the cap period.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Service Intensity Add-On.</text> <paragraph num="(1)"> <text>In addition to the routine home care rate paid under §B(1) of this regulation, the provider shall be paid for visits made by a social worker or a registered nurse, when provided during routine home care in the last 7 days of the participant’s life.</text> </paragraph> <paragraph num="(2)"> <text>The service intensity add-on payment is equal to the continuous home care hourly rate divided by four.</text> </paragraph> <paragraph num="(3)"> <text>The provider shall be paid in 15-minute increments for a maximum of four hours daily.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment for Physician Services.</text> <paragraph num="(1)"> <text>The per diem rates are designed to reimburse for those administrative and general supervisory activities performed by physicians who are employees of or are working under arrangements with the provider. These activities are generally performed by the physician serving as the medical director or the physician member of the provider's interdisciplinary group. The included activities consist of participation in establishment of care plans, supervision of service delivery, periodic review and updating of care plans, and establishment of governing policies.</text> </paragraph> <paragraph num="(2)"> <text>In addition to the daily rates, the Program shall make separate payment to the provider for physician services, subject to the following requirements:</text> <paragraph num="(a)"> <text>The services shall be direct patient care services furnished to a participant under the care of the provider;</text> </paragraph> <paragraph num="(b)"> <text>The services shall be furnished by an employee of the provider or furnished under arrangements made by the provider;</text> </paragraph> <paragraph num="(c)"> <text>The provider shall have a liability to reimburse the physician for the services rendered;</text> </paragraph> <paragraph num="(d)"> <text>The provider shall bill for the physician services in accordance with procedures established by the Program;</text> </paragraph> <paragraph num="(e)"> <text>A payment may not be made for physician services furnished on a volunteer basis; and</text> </paragraph> <paragraph num="(f)"> <text>Payment to the provider for physicians' services shall be made in accordance with the fee schedule contained in COMAR 10.09.02.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A physician who is designated as the attending physician by a participant and who also volunteers services to the provider is considered an employee of the provider, whose direct patient care services furnished to the participant on a nonvolunteer basis shall be reimbursed to the provider in accordance with §D(2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>A physician who is designated as the attending physician by a participant and who is not an employee of the provider or receiving compensation from the provider shall be paid by the Program in accordance with COMAR 10.09.02. The attending physician may bill the Program only for personal professional services.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When a participant resides in a nursing facility, the Program shall pay an additional per diem amount for room and board to the provider, subject to the following requirements:</text> <paragraph num="(1)"> <text>The additional amount shall be paid only for those days that the provider is reimbursed at the routine or continuous home care rate for hospice care furnished to the participant;</text> </paragraph> <paragraph num="(2)"> <text>The amount shall be the per diem reimbursement established by the Program to pay for room and board in the facility;</text> </paragraph> <paragraph num="(3)"> <text>The amount shall be paid to the provider only when the provider and the facility have a written agreement under which the provider is responsible for the professional management of the participant's hospice care and the facility agrees to provide room and board to the participant;</text> </paragraph> <paragraph num="(4)"> <text>While the provider is being reimbursed for hospice care furnished to a participant residing in a nursing facility, Program payment to the facility shall be discontinued; and</text> </paragraph> <paragraph num="(5)"> <text>The Department of Human Services shall determine the application of a recipient's resource to the cost of hospice care pursuant to COMAR 10.09.24 and COMAR 10.09.25. The provider:</text> <paragraph num="(a)"> <text>Shall collect a recipient's resource available for hospice care as certified by the Department of Human Services,</text> </paragraph> <paragraph num="(b)"> <text>May not collect a total payment, including the recipient's resource and the Department's payment, which exceeds the amount the provider would be paid in accordance with this regulation for a day of hospice care, and</text> </paragraph> <paragraph num="(c)"> <text>Shall show sums collected from a recipient's available resource as patient collection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Requests for Payment. Requests for payment for hospice care services rendered shall be submitted as set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Appeal Procedures."> <text>Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 1989 (16:16 Md. R. 1751)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 22, 2013 (40:14 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 22, 2013 (40:14 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 22, 2013 (40:14 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective July 22, 2013 (40:14 Md. R. 1174)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 21, 2025 (52:14 Md. R. 712)</annotation> </annotations> </chapter> <chapter num="36" heading="General Medical Assistance Provider Participation Criteria"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms apply to Medical Assistance providers. Additional defined terms, unique to Medical Assistance provided services, are found in Medical Assistance service-specific chapters.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abandoned” means failing to appear for a hearing on the established date without good cause.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland, to:</text> <paragraph num="(a)"> <text>Adjudicate contested cases at the Maryland Office of Administrative Hearings; and</text> </paragraph> <paragraph num="(b)"> <text>Render a proposed decision for purposes of COMAR 28.02.01.22.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Care manager” means a:</text> <paragraph num="(a)"> <text>Primary medical provider under the Diabetes Care Program, in accordance with COMAR 10.09.43, or the Maryland Access to Care Program, in accordance with COMAR 10.09.44;</text> </paragraph> <paragraph num="(b)"> <text>Primary care provider under the corrective managed care program, in accordance with COMAR 10.09.24.15B and 10.09.25.14B; or</text> </paragraph> <paragraph num="(c)"> <text>Hospice provider under the hospice care program, in accordance with COMAR 10.09.35.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Claim” means:</text> <paragraph num="(a)"> <text>A bill for services;</text> </paragraph> <paragraph num="(b)"> <text>A line item of service; or</text> </paragraph> <paragraph num="(c)"> <text>All services for one participant within a bill.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Clean Claim.</text> <paragraph num="(a)"> <text>“Clean claim” means a claim that can be processed consistent with applicable regulations without obtaining additional information from the provider of the service or from a third party.</text> </paragraph> <paragraph num="(b)"> <text>“Clean claim” includes a claim with errors originating in a State's claims system;</text> </paragraph> <paragraph num="(c)"> <text>“Clean claim” does not include a claim:</text> <paragraph num="(i)"> <text>From a provider who is under investigation for fraud or abuse; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Current Procedural Terminology (CPT)” means the American Medical Association’s uniform nomenclature for coding medical procedures and services.</text> </paragraph> <paragraph num="(7)"> <text>“Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific item or service, excluding token charges for charity patients and substandard charges for welfare and other low-income patients.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health, which is the single state agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(9)"> <text>“Emergency services” means those services which are provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing health in jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions;</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part; or</text> </paragraph> <paragraph num="(d)"> <text>Development or continuance of severe pain.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Healthcare Common Procedure Coding System (HCPCS)” means the specified code set for procedures and services, according to the Health Insurance Portability and Accountability Act (HIPAA).</text> </paragraph> <paragraph num="(11)"> <text>“Managed care" means the care manager's provision of comprehensive primary care and referral services to an enrollee in a managed care program.</text> </paragraph> <paragraph num="(12)"> <text>“Managed care program” means:</text> <paragraph num="(a)"> <text>Maryland Access to Care Program under COMAR 10.09.44;</text> </paragraph> <paragraph num="(b)"> <text>Diabetes Care Program under COMAR 10.09.43;</text> </paragraph> <paragraph num="(c)"> <text>Corrective managed care under COMAR 10.09.24.15B or 10.09.25.14B; or</text> </paragraph> <paragraph num="(d)"> <text>Hospice care under COMAR 10.09.35.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(14)"> <text>“Medical Care Programs" means the unit of the Department responsible for the administration of the Medical Assistance Program.</text> </paragraph> <paragraph num="(15)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(17)"> <text>Overpayment.</text> <paragraph num="(a)"> <text>“Overpayment” means any payment made by the Medicaid Program to a provider for medical care provided to a participant which at the time of payment, or at a subsequent date, is determined to be:</text> <paragraph num="(i)"> <text>A duplicate payment;</text> </paragraph> <paragraph num="(ii)"> <text>A payment for services for which reimbursement is claimed when all or any part of the claim submitted to the Department is for services that were provided in violation of one or more regulations;</text> </paragraph> <paragraph num="(iii)"> <text>Excessive in amount; or</text> </paragraph> <paragraph num="(iv)"> <text>The primary obligation of a health insurance carrier or any other person, including the participant, who is legally or contractually obligated to pay for that medical care.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Overpayment” does not include an amount recovered as part of a routine cost settlement process.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(19)"> <text>“Primary care” means that medical care which addresses a patient's general health needs including the coordination of the patient's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, and referral to other specialists for more intensive care when appropriate.</text> </paragraph> <paragraph num="(20)"> <text>“Program" means the Medical Assistance Program.</text> </paragraph> <paragraph num="(21)"> <text>“Provider” means:</text> <paragraph num="(a)"> <text>An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number;</text> </paragraph> <paragraph num="(b)"> <text>An agent, employee, or related party of a person identified in §B(19)(a) of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>An individual or any other person with an ownership interest in a person identified in §B(19)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“State Department of Assessments and Taxation (SDAT)” means the State Department of Assessments and Taxation as described in COMAR Title 18.</text> </paragraph> <paragraph num="(23)"> <text>“Withhold payment” means the Program's decision to not pay or suspend payment to a provider as a sanction for failure to comply with applicable federal or State laws or regulations or because of a credible allegation of fraud.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>Medical Assistance Program providers shall, to the extent required by law, be licensed, certified, or otherwise legally authorized to practice or deliver services in the state in which the service is provided.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>To participate in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Ensure compliance with all the Medical Assistance provisions listed in the Code of Maryland Regulations (COMAR) designated for their provider type;</text> </paragraph> <paragraph num="(2)"> <text>Apply for participation in the Program using the application form designated by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Obtain and maintain in good standing the appropriate SDAT identification number in accordance with §I of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Allow the Department or its agents to conduct unannounced on-site inspections of any and all provider locations;</text> </paragraph> <paragraph num="(6)"> <text>Allow the Department or its agents to require all providers to consent to criminal background checks, including fingerprinting;</text> </paragraph> <paragraph num="(7)"> <text>Have a current provider agreement with the Program in effect and fully comply with the terms and conditions stated in the provider agreement;</text> </paragraph> <paragraph num="(8)"> <text>Comply with all standards of practice, professional standards and levels of service as set forth in all applicable federal and State laws, statues, rules, and regulations as well as all administrative policies, procedures, transmittals, and guidelines issued by the Department;</text> </paragraph> <paragraph num="(9)"> <text>Charge the Program the provider's customary charge to the general public for similar items or services. If the item or service is free to individuals not covered by Medicaid:</text> <paragraph num="(a)"> <text>The provider:</text> <paragraph num="(i)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be reimbursed in accordance with the Department's rate provisions; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="(11)"> <text>Accept payment by the Program as payment in full for covered services rendered and make no additional charge to any person for covered services;</text> </paragraph> <paragraph num="(12)"> <text>Provide services without regard to race, color, age, sex, national origin, religion, sexual orientation, gender identity, marital status, or physical or mental disability;</text> </paragraph> <paragraph num="(13)"> <text>Verify the participant’s eligibility by:</text> <paragraph num="(a)"> <text>Viewing the participant’s Medical Assistance card and another identification card; and</text> </paragraph> <paragraph num="(b)"> <text>Calling the Program's Eligibility Verification Interactive Voice Response System (EVS/IVR) or accessing the web-based participant eligibility system;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Place no restriction on a participant’s right to select health care providers of the participant’s choice, except that a participant in a managed care program shall be required to obtain certain specified Program services from or through the participant's care manager, in accordance with the restrictions imposed by the managed care program;</text> </paragraph> <paragraph num="(15)"> <text>Not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department;</text> </paragraph> <paragraph num="(16)"> <text>Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement, on the form and at the time specified by the Department;</text> </paragraph> <paragraph num="(17)"> <text>Maintain the confidentiality of all participant information by not releasing the information without authorization by the participant or as authorized by law;</text> </paragraph> <paragraph num="(18)"> <text>Have an individual rendering number for practitioners recognized by the Program;</text> </paragraph> <paragraph num="(19)"> <text>Obtain a referral from a participant’s care manager in a manner prescribed by the Department before rendering services, when:</text> <paragraph num="(a)"> <text>The participant is enrolled in a managed care program; and</text> </paragraph> <paragraph num="(b)"> <text>The service is included under the managed care program's referral requirements.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Supply a signed service order or prescription that includes the individual rendering number of the ordering or prescribing practitioner, as well as the full name and Medical Assistance number of the participant, when ordering services to be supplied by other providers, such as hospital admission, diagnostic testing, supplies, or pharmacy services;</text> </paragraph> <paragraph num="(21)"> <text>Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed;</text> </paragraph> <paragraph num="(22)"> <text>Provide a participant’s medical records at no charge when the records are requested by another physician or licensed provider on behalf of the participant; and</text> </paragraph> <paragraph num="(23)"> <text>Comply with the requirements of COMAR 10.01.04.12 regarding the designation of an authorized representative;</text> </paragraph> <paragraph num="(24)"> <text>Place no restriction on a participant’s fair hearing appeal rights as a condition of rendering services; and</text> </paragraph> <paragraph num="(25)"> <text>Comply with provider audits authorized by State and federal law to ensure compliance with Program requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Enrollment Effective Date.</text> <paragraph num="(1)"> <text>Unless a provider is enrolled under the provisions of §B(2) of this regulation, the effective date of a provider’s enrollment is the date the Program completes all screenings required by State and federal law, which may include a site visit, following the Program’s receipt of the provider’s submission of a complete application with all required supporting documents.</text> </paragraph> <paragraph num="(2)"> <text>If an out-of-State emergency transportation services or emergency services provider meets provider enrollment requirements, the enrollment effective date is the date the provider renders the emergency services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A provider may not seek payment from more than one State agency for the same service.</text> </paragraph> <paragraph num="D."> <text>If the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the participant.</text> </paragraph> <paragraph num="E."> <text>If the Program denies payment for covered services for any reason, the provider may not seek payment for the denied service from the participant.</text> </paragraph> <paragraph num="F."> <text>The Program may pay for a covered service rendered by a provider to a participant under any of the following circumstances:</text> <paragraph num="(1)"> <text>The provider charges for nonparticipants who receive the same service by:</text> <paragraph num="(a)"> <text>Charging the individual in full for services rendered;</text> </paragraph> <paragraph num="(b)"> <text>Using a sliding fee scale based on the individual's income;</text> </paragraph> <paragraph num="(c)"> <text>Waiving all or part of the fee for a specific individual; or</text> </paragraph> <paragraph num="(d)"> <text>Agreeing to accept what a third party pays as payment in full, whether or not the provider bills individuals who lack this coverage;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The State, using its own funds, pays for services rendered to a targeted group of nonparticipants, and the provider charges nontargeted users of the services;</text> </paragraph> <paragraph num="(3)"> <text>The provider bills all individuals with third party coverage, whether or not the provider bills individuals who lack this coverage;</text> </paragraph> <paragraph num="(4)"> <text>The service is offered by or through the State agency which administers the program of services authorized under Title V of the Social Security Act; or</text> </paragraph> <paragraph num="(5)"> <text>The service is offered to a handicapped child receiving services under the Education for the Handicapped Act (EHA) under an individualized education plan (IEP).</text> </paragraph> </paragraph> <paragraph num="G."> <text>The following types of providers shall comply with the requirements of 42 CFR Part 489, Subpart I, Advance Directives:</text> <paragraph num="(1)"> <text>Acute hospitals under COMAR 10.09.92;</text> </paragraph> <paragraph num="(2)"> <text>Chronic hospitals under COMAR 10.09.93;</text> </paragraph> <paragraph num="(3)"> <text>Special pediatric hospitals under COMAR 10.09.94;</text> </paragraph> <paragraph num="(4)"> <text>Special psychiatric hospitals under COMAR 10.09.95;</text> </paragraph> <paragraph num="(5)"> <text>Nursing facilities under COMAR 10.09.10 and COMAR 10.09.11;</text> </paragraph> <paragraph num="(6)"> <text>Home health agencies under COMAR 10.09.04;</text> </paragraph> <paragraph num="(7)"> <text>Personal care case monitors under COMAR 10.09.20;</text> </paragraph> <paragraph num="(8)"> <text>Model waiver nursing services providers under COMAR 10.09.27; and</text> </paragraph> <paragraph num="(9)"> <text>Hospices under COMAR 10.09.35.</text> </paragraph> </paragraph> <paragraph num="H."> <text>For services that are funded under the Substance Abuse and Mental Health Services Administration and related federal funding sources, specifically for providers that bill the public behavioral health system for specialty mental health services described in COMAR 10.09.59 and community-based substance use disorder services described in COMAR 10.09.80 shall provide data elements per Federal requirements set forth in 42 U.S. Code §300x–9 and 42 USC 300x-35, to the State in the frequency required by the Department.</text> </paragraph> <paragraph num="I."> <text>State Department of Assessments and Taxation (SDAT) Identification Number. A provider shall obtain an SDAT identification number that:</text> <paragraph num="(1)"> <text>Identifies their organizational structure as either:</text> <paragraph num="(a)"> <text>An individual provider, classified with a prefix of the letter L; or</text> </paragraph> <paragraph num="(b)"> <text>A business entity; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is maintained in good standing as described in COMAR 18.04.03.01.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Each provider practice location shall:</text> <paragraph num="(1)"> <text>Be individually enrolled with the Program;</text> </paragraph> <paragraph num="(2)"> <text>Have an individualized provider agreement as described under §A(6) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Maintain a unique NPI number as described under §K of this regulation.</text> </paragraph> </paragraph> <paragraph num="K."> <text>National Provider Identification (NPI) Number.</text> <paragraph num="(1)"> <text>Unless specifically excepted under §K(2) of this regulation, each provider shall maintain a unique NPI number that:</text> <paragraph num="(a)"> <text>Correctly classifies the provider as either:</text> <paragraph num="(i)"> <text>An individual provider with a Type 1 NPI number; or</text> </paragraph> <paragraph num="(ii)"> <text>An organizational provider with a Type 2 NPI number; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For Type 2 organizational providers, is individualized to a specific service or practice location.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following enrollment types are exempt from the individualized Type 2 NPI number requirement in §K(1)(b) of this regulation:</text> <paragraph num="(a)"> <text>Skilled nursing facility therapy groups with an affiliated nursing facility provider;</text> </paragraph> <paragraph num="(b)"> <text>Pharmacies with an affiliated durable medical equipment and disposable medical supplies provider; and</text> </paragraph> <paragraph num="(c)"> <text>Hospitals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>Providers may not request or require that a participant waive, revoke, or otherwise forgo Medicaid coverage as a condition for receiving covered services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Conditions for Participation — Home and Community-Based Settings."> <paragraph num="A."> <text>Providers of services under COMAR 10.09.84 shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4).</text> </paragraph> <paragraph num="B."> <text>Effective January 1, 2018, to be enrolled as a provider of services authorized under §§1915(c) or 1915(i) of the Social Security Act, the provider shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4).</text> </paragraph> <paragraph num="C."> <text>Providers of services authorized under §§1915(c) or 1915(i) of the Social Security Act that are enrolled Maryland Medicaid providers before January 1, 2018, shall comply with the provisions of §§D—F of this regulation on or before March 17, 2022.</text> </paragraph> <paragraph num="D."> <text>The setting in which services are provided shall:</text> <paragraph num="(1)"> <text>Be integrated in and support full access to the greater community for individuals receiving Medicaid home and community-based services to the same degree of access as individuals not receiving Medicaid home and community-based services;</text> </paragraph> <paragraph num="(2)"> <text>Be selected by the individual from among setting options, including nondisability specific settings;</text> </paragraph> <paragraph num="(3)"> <text>Be identified and documented in the person-centered service plan and is based on the individual’s needs and preferences;</text> </paragraph> <paragraph num="(4)"> <text>Ensure an individual’s rights of:</text> <paragraph num="(a)"> <text>Privacy;</text> </paragraph> <paragraph num="(b)"> <text>Dignity and respect; and</text> </paragraph> <paragraph num="(c)"> <text>Freedom from coercion and restraint;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Optimize, but not regiment, individual initiative, autonomy, and independence in making life choices, including but not limited to:</text> <paragraph num="(a)"> <text>Daily activities;</text> </paragraph> <paragraph num="(b)"> <text>Physical environment; and</text> </paragraph> <paragraph num="(c)"> <text>With whom to interact; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Facilitate individual choice regarding services and supports, and who provides them.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the provisions of §D of this regulation, provider-owned or controlled settings shall meet the following conditions:</text> <paragraph num="(1)"> <text>The unit or dwelling is a specific physical place that can be owned, rented, or occupied under a legally enforceable agreement by the individual receiving services and the individual has, at a minimum, the same responsibilities and protections from eviction that tenants have under the landlord tenant law of the State, county, city, or other designated entity;</text> </paragraph> <paragraph num="(2)"> <text>Each individual has privacy in their sleeping or living unit, as evidenced by the following:</text> <paragraph num="(a)"> <text>Units have entrance doors lockable by the individual, with only appropriate staff having keys to doors;</text> </paragraph> <paragraph num="(b)"> <text>Individuals sharing units have a choice of roommates; and</text> </paragraph> <paragraph num="(c)"> <text>Individuals have the freedom to furnish and decorate their sleeping or living units within the lease or other agreement;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Individuals have the freedom and support to control their own schedules and activities;</text> </paragraph> <paragraph num="(4)"> <text>Individuals have access to food at any time;</text> </paragraph> <paragraph num="(5)"> <text>Individuals are able to have visitors of their choosing at any time; and</text> </paragraph> <paragraph num="(6)"> <text>The setting is physically accessible to the individual.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Any modification of the conditions under §§D and E of this regulation shall be supported by a specific assessed need and justified in the person-centered services plan in accordance with 42 CFR 441.301(c)(2)(xiii).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-2" heading="Conditions for Participation — Data Management Systems and Electronic Visit Verification."> <paragraph num="A."> <text>This regulation establishes standards for providers using Data Management systems.</text> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Data management system” means a health information technology solution used by the Maryland Department of Health (Department), its agents, providers, and Program participants that stores provider or participant protected health information (PHI) or personally identifiable information (PII) and related business processes.</text> </paragraph> <paragraph num="(b)"> <text>“Electronic visit verification (EVV)” means an electronic service entry method used to record service details, including but not limited to service type, provider and participant information, date of service, service delivery location, and beginning and ending times of service that meets the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines.</text> </paragraph> <paragraph num="(c)"> <text>Electronic visit verification (EVV) services means services that are:</text> <paragraph num="(i)"> <text>Covered Medicaid services, according to the respective authority, including but not limited to the Medicaid State Plan, a Medicaid waiver program, or regulations; and</text> </paragraph> <paragraph num="(ii)"> <text>Required to be electronically recorded in the Department’s EVV system or approved financial management and counseling services contractors’ EVV solutions pursuant to 42 U.S.C. §1396b(l) and other State and federal laws, regulations, or guidance except in circumstances when the services, provided under the agency, traditional, or self-directed delivery model, are provided by a live-in caregiver or worker and exempted by the Department, or otherwise exempted by the Department and the participant elects to forego the electronic process.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>“Financial management and counseling services (FMCS) contractors” means agencies that provide financial management and counseling services to support individuals who choose the self-direction delivery model.</text> </paragraph> <paragraph num="(e)"> <text>“Live-in caregiver” means a paid personal caregiver who permanently, or for an extended period of time approved by the Department, resides in the same residence as the Medicaid participant for whom they are providing services and supports.</text> </paragraph> <paragraph num="(f)"> <text>“Preauthorized” means approved by the Department or its designee before services are rendered.</text> </paragraph> <paragraph num="(g)"> <text>“Worker” means an individual, who may be referred to as a caregiver, who is employed by or contracts with a provider or self-directing participant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Requirements for Using Data Management Systems. Providers shall:</text> <paragraph num="(1)"> <text>Register and credential all system users in the manner specified by the Department with valid and accurate information;</text> </paragraph> <paragraph num="(2)"> <text>Properly train all workers registered as system users on proper protocols for conducting system activities, including:</text> <paragraph num="(a)"> <text>Accurate entry of information into the system;</text> </paragraph> <paragraph num="(b)"> <text>Proper use of hardware and equipment required to use the system;</text> </paragraph> <paragraph num="(c)"> <text>EVV, including but not limited to recording and modifying billing entries, participant and provider information, or other records, in accordance with the policies and procedures issued by the Department, unless otherwise exempted by the Department; and</text> </paragraph> <paragraph num="(d)"> <text>Protection of protected health information in compliance with State and federal law, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA);</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Comply with the laws and regulations concerning the privacy and security of protected health information under State and federal law, including HIPAA; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that any provider-owned systems and devices responsible for sending, retrieving, or storing data from a State-operated data management system comply with all Department, State and federal regulations, policies, and procedures regarding information technology privacy and security.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Requirements for EVV Use.</text> <paragraph num="(1)"> <text>Agency providers and workers shall use the EVV method and data management system approved by the Department, unless otherwise exempted by the Department, to:</text> <paragraph num="(a)"> <text>Meet the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines; and</text> </paragraph> <paragraph num="(b)"> <text>Submit claims.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall reimburse for EVV services if the service is:</text> <paragraph num="(a)"> <text>Electronically recorded through the EVV method and data management system approved by the Department in accordance with Department regulations, policies, and procedures;</text> </paragraph> <paragraph num="(b)"> <text>Recorded using a manual or alternate electronic timekeeping process and data management system approved by the Department in accordance with Department regulations, policies, and procedures when the live-in caregiver exemption is applicable and elected;</text> </paragraph> <paragraph num="(c)"> <text>Preauthorized in the manner designated by the Department for the service type;</text> </paragraph> <paragraph num="(d)"> <text>Directly provided to the participant in-person, unless otherwise authorized by the Department; and</text> </paragraph> <paragraph num="(e)"> <text>Delivered in accordance with all applicable Department regulations, policies, and procedures for the service type.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Program does not cover services, even those exempted from EVV, provided:</text> <paragraph num="(a)"> <text>During periods of participant ineligibility;</text> </paragraph> <paragraph num="(b)"> <text>During time periods that overlap with the worker’s time period for the same or another participant unless otherwise authorized by the appropriate program authority for the service type; or</text> </paragraph> <paragraph num="(c)"> <text>During time periods that overlap with the same or another worker’s time period for the same participant unless otherwise authorized by the appropriate program authority for the service type.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Department.</text> </paragraph> <paragraph num="C."> <text>The Program will make no direct payment to recipients.</text> </paragraph> <paragraph num="D."> <text>All payments are contingent upon a provider’s full compliance with the requirements of its enrollment and applicable conditions of participation.</text> </paragraph> <paragraph num="E."> <text>Unless the service is free to the general public, the provider shall charge the Program its customary charge to the general public for similar services.</text> </paragraph> <paragraph num="F."> <text>Unless otherwise excepted, the provider shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge unless the service is free to individuals not covered by the Program; or</text> </paragraph> <paragraph num="(2)"> <text>The Department’s applicable rate.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Unless otherwise excepted, if a service is free to individuals not covered by the Program:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §F of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Providers may not bill the Department, the Program, or participants for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Covered professional services rendered by:</text> <paragraph num="(a)"> <text>Mail;</text> </paragraph> <paragraph num="(b)"> <text>Email; or</text> </paragraph> <paragraph num="(c)"> <text>Fax; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Unless otherwise excepted, payments on Medicare claims are authorized, if:</text> <paragraph num="(1)"> <text>Services are covered by the Medicare Program;</text> </paragraph> <paragraph num="(2)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(3)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(4)"> <text>Medicare has determined that services were medically justified; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Unless otherwise provided by regulation, supplemental payments on Medicare claims are made subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance will be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service and subject to the limitations of the State budget, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare are payable according to §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An individual or entity who is employed by or under contract to any group provider, clinic, or hospital may not bill for any service for which reimbursement is sought by the group provider, clinic, or hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Cost Reporting."> <paragraph num="A."> <text>Providers who are reimbursed on the basis of cost reports shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="B."> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="C."> <text>An extension shall be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable.</text> </paragraph> <paragraph num="D."> <text>Availability of Records.</text> <paragraph num="(1)"> <text>The provider shall keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours.</text> </paragraph> <paragraph num="(2)"> <text>Documentation of Costs.</text> <paragraph num="(a)"> <text>Upon request by the Department or the Department's designee, the provider shall make documentation of costs available during the course of verification.</text> </paragraph> <paragraph num="(b)"> <text>The provider shall have 30 days from the date of the request to provide this documentation.</text> </paragraph> <paragraph num="(c)"> <text>Costs for which documentation is not provided within the 30 days shall be considered not allowable.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon written demonstration by the provider of good cause, the Department may grant, in writing, an extension of time to provide the requested documentation.</text> </paragraph> <paragraph num="(4)"> <text>Records shall be retained for 6 years after the month in which the cost report to which the materials apply is filed with the Department or the Department's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Billing Time Limitations."> <paragraph num="A."> <text>Definition.</text> <paragraph num="(1)"> <text>In this regulation, the following term has the meaning indicated.</text> </paragraph> <paragraph num="(2)"> <text>Term Defined. “Received” means:</text> <paragraph num="(a)"> <text>The Program taking delivery of a claim after the Program signs a certified mail, return receipt requested parcel from the United States Postal Service; or</text> </paragraph> <paragraph num="(b)"> <text>The claim is reported on the provider’s remittance advice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Unless specified in Regulation .03A(1) of this chapter, the following apply:</text> <paragraph num="(1)"> <text>The Department may not reimburse the claims received by the Program for payment more than 12 months after the date of service.</text> </paragraph> <paragraph num="(2)"> <text>Medicare Claims. For any claim initially submitted to Medicare and for which services have been:</text> <paragraph num="(a)"> <text>Approved, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later; and</text> </paragraph> <paragraph num="(b)"> <text>Denied, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Fee for Service Claims.</text> <paragraph num="(a)"> <text>Fee for service claims shall be submitted and received by the Program within 12 months of:</text> <paragraph num="(i)"> <text>The date of service;</text> </paragraph> <paragraph num="(ii)"> <text>The date of discharge, if the service was a hospital inpatient service; or</text> </paragraph> <paragraph num="(iii)"> <text>The month of service, if the service was provided in a nursing or rehabilitation facility or is a hospice service.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Program shall only pay claims for services provided on different dates and submitted on a single claim if the single claim form is received by the Program within 12 months of the earliest date of service.</text> </paragraph> <paragraph num="(c)"> <text>The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is:</text> <paragraph num="(i)"> <text>Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines;</text> </paragraph> <paragraph num="(ii)"> <text>Resubmitted; and</text> </paragraph> <paragraph num="(iii)"> <text>Received by the Program within the later of 12 months from the date of service or 60 days from the date last received by the Program or last rejected by the Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>A claim for services provided on different dates and submitted on a single form shall be paid only if it is received by the Program within 12 months of the earliest date of service.</text> </paragraph> <paragraph num="(5)"> <text>The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is:</text> <paragraph num="(a)"> <text>Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines;</text> </paragraph> <paragraph num="(b)"> <text>Resubmitted; and</text> </paragraph> <paragraph num="(c)"> <text>Received by the Program within the later of:</text> <paragraph num="(i)"> <text>12 months from the date of service; or</text> </paragraph> <paragraph num="(ii)"> <text>60 days from the date last received by the Program or last rejected by the Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Claims submitted after the time limitations because of a retroactive eligibility determination shall be considered for payment if received by the Program within 12 months of the date on which eligibility was determined.</text> </paragraph> <paragraph num="(7)"> <text>Late Charge Billing.</text> <paragraph num="(a)"> <text>The Program shall only accept additional or supplemental claims that were not included with a larger primary claim paid by the Program if all of the additional or supplemental claims are:</text> <paragraph num="(i)"> <text>Submitted together;</text> </paragraph> <paragraph num="(ii)"> <text>Submitted in accordance with the requirements of §B(3) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Received within 60 days of the original paid claim date.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Program shall only accept one additional or supplemental claim under §B(7)(a) of this regulation for each:</text> <paragraph num="(i)"> <text>Date of service;</text> </paragraph> <paragraph num="(ii)"> <text>Date of discharge; or</text> </paragraph> <paragraph num="(iii)"> <text>Month of service billed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Adjustment Requests. Requests by providers to adjust information in claims already paid, including but not limited to changing the days billed, the amount charged, the units of service, or the rate of the service, shall be submitted to the Program in accordance with §B(3) and (5) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, covered services, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The Program shall pay the difference between what was paid by the insurance carrier and the Program's maximum fees. Total payment cannot exceed the Program's maximum fee. The provider shall submit a copy of the insurance carrier's notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> <paragraph num="C."> <text>The Department may conduct provider audits as authorized by State and federal law to ensure compliance with Program requirements.</text> </paragraph> <paragraph num="D."> <text>For audits commencing on or after July 1, 2004, if the provider fails to reimburse the Department in accordance with §§A and B of this regulation, the provider shall be responsible for reimbursing the Department for the amount of the overpayment and any audit costs incurred by the Department in seeking recovery of the overpayment.</text> </paragraph> <paragraph num="E."> <text>An audit is considered to have commenced upon the initial written notification by the Department or the Department's agent to the provider.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Recovery of an overpayment;</text> </paragraph> <paragraph num="(4)"> <text>Removal from the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department shall take similar action.</text> </paragraph> <paragraph num="C."> <text>The Department may report to the federal Secretary of Health and Human services any providers removed from participation with the Program for failure to comply with applicable federal or State laws and regulations in accordance with 42 CFR §455.416.</text> </paragraph> <paragraph num="D."> <text>The Department shall give the provider reasonable notice of its intention to impose sanctions. In the written notice, the Department shall establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.</text> </paragraph> <paragraph num="E."> <text>A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Filing Appeal."> <paragraph num="A."> <text>Source of Appeals.</text> <paragraph num="(1)"> <text>A provider may file an appeal from a proposed Program action to:</text> <paragraph num="(a)"> <text>Suspend the provider from the Program;</text> </paragraph> <paragraph num="(b)"> <text>Withhold payment by the Program;</text> </paragraph> <paragraph num="(c)"> <text>Recover an overpayment;</text> </paragraph> <paragraph num="(d)"> <text>Remove the provider from the Program; or</text> </paragraph> <paragraph num="(e)"> <text>Disqualify the provider from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A provider shall submit an appeal according to:</text> <paragraph num="(a)"> <text>COMAR 10.01.03;</text> </paragraph> <paragraph num="(b)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Health-General Article, §§2-201—2-207, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>COMAR 28.02.01.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A provider may not file an appeal from a Program action to terminate the provider when that action is the result of either:</text> <paragraph num="(a)"> <text>Termination of the provider or an owner by the federal government or another state Medicaid agency pursuant to 42 CFR §445.416; or</text> </paragraph> <paragraph num="(b)"> <text>Suspension or termination of the provider’s license or certificate by their respective licensing or certification authority.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Request for a Hearing.</text> <paragraph num="(1)"> <text>An appeal of a proposed Program action shall be filed in writing with the Program within 30 days of the date of the notice of the proposed Program action. The Program shall make reasonable accommodation if a provider cannot submit a written request because of a disability.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall immediately forward a written appeal request to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Promptly acknowledge any appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider and the Program in writing of the date, time, and place of the hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Effective Date. The proposed Program action shall be effective on:</text> <paragraph num="(1)"> <text>The date of the proposed Program action notice if the Program:</text> <paragraph num="(a)"> <text>Determines that the provider poses an imminent threat to public health, safety, or welfare that requires emergency action; and</text> </paragraph> <paragraph num="(b)"> <text>Notifies the provider of this determination in the proposed Program action notice;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The date specified in the proposed Program action notice if the provider:</text> <paragraph num="(a)"> <text>Does not request a hearing within 30 days of the date of the notice of the proposed Program action; or</text> </paragraph> <paragraph num="(b)"> <text>Withdraws in writing or abandons a request for a hearing before the effective date of the proposed Program action;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The first payment date following the date of the Program action notice if the Program action involves withholding payment to the provider because the Program discovered an overpayment to the provider;</text> </paragraph> <paragraph num="(4)"> <text>The date the administrative law judge renders a decision in favor of the Program if the provider:</text> <paragraph num="(a)"> <text>Fails to timely file exceptions to the administrative law judge's decision with the Secretary pursuant to §D of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Withdraws in writing or abandons a request for an exceptions hearing before the date of the exceptions hearing; or</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The date the Secretary renders a decision in favor of the Program pursuant to COMAR 10.01.03 if any party files exceptions with the Secretary in accordance with §E(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A Program determination to suspend payments due to a credible allegation of fraud shall be effective immediately unless the Department determines, consistent with 42 CFR §455.23, that a good cause exception to immediate suspension exists.</text> </paragraph> <paragraph num="E."> <text>Exceptions and Outcomes.</text> <paragraph num="(1)"> <text>A party may seek additional administrative review of the administrative law judge's decision by filing in writing exceptions with the Secretary within 30 days of the date of the administrative law judge's decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary's decision is favorable to the Program, the Program may:</text> <paragraph num="(a)"> <text>Immediately implement the proposed Program action; and</text> </paragraph> <paragraph num="(b)"> <text>Institute recovery procedures against the provider to recoup the cost of any payments made to the provider to the extent the payments were made solely because the provider was permitted to continue to submit claims to the Department because of §C(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the proposed Program action was effective on the date of the notice as provided for in §B(1) of this regulation, the Program shall authorize corrected payments or relief retroactive to the date of the notice if:</text> <paragraph num="(a)"> <text>The Secretary's decision is favorable to the provider; or</text> </paragraph> <paragraph num="(b)"> <text>The Program grants the provider the relief the provider requests before the Secretary's decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Further Appeals. The provider may seek additional administrative review of the Secretary's decision as provided in Health-General Article, §§2-206 and 2-207, Annotated Code of Maryland, and subsequent judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Provider Rights."> <text>Providers participating in the Program shall have the right to:</text> <paragraph num="A."> <text>Be treated professionally with courtesy, dignity, and respect regardless of the individual's:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Color;</text> </paragraph> <paragraph num="(3)"> <text>Religion;</text> </paragraph> <paragraph num="(4)"> <text>Gender;</text> </paragraph> <paragraph num="(5)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(6)"> <text>National origin;</text> </paragraph> <paragraph num="(7)"> <text>Political affiliation;</text> </paragraph> <paragraph num="(8)"> <text>Disability;</text> </paragraph> <paragraph num="(9)"> <text>Marital status;</text> </paragraph> <paragraph num="(10)"> <text>Age; or</text> </paragraph> <paragraph num="(11)"> <text>Union affiliation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>File a complaint with the appropriate State agency when the provider believes that the provider has been discriminated against because of:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Color;</text> </paragraph> <paragraph num="(3)"> <text>Religion;</text> </paragraph> <paragraph num="(4)"> <text>Gender;</text> </paragraph> <paragraph num="(5)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(6)"> <text>National origin;</text> </paragraph> <paragraph num="(7)"> <text>Political affiliation;</text> </paragraph> <paragraph num="(8)"> <text>Disability;</text> </paragraph> <paragraph num="(9)"> <text>Marital status;</text> </paragraph> <paragraph num="(10)"> <text>Age; or</text> </paragraph> <paragraph num="(11)"> <text>Union affiliation;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Have the information in the provider's Program file kept confidential except as otherwise stated by State or federal law;</text> </paragraph> <paragraph num="D."> <text>Be reimbursed for covered services provided to Program participants; and</text> </paragraph> <paragraph num="E."> <text>Participate in an impartial grievance and appeals process as outlined in COMAR 10.09.36.09.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective October 1, 1990 (17:18 Md. R. 2201)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01A and .03A amended, and .03D adopted as an emergency provision effective February 27, 1992 (19:6 Md. R. 669); adopted permanently effective June 22, 1992 (19:11 Md. R. 1015)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01A, .06A, B amended, and .06C—E adopted as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01A and .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 849); August 27, 2007 (34:17 Md. R. 1507); January 24, 2011 (38:2 Md. R. 84); July 4, 2016 (43:13 Md. R. 712); June 14, 2021 (48:12 Md. R. 473); September 18, 2023 (50:18 Md. R. 794); August 5, 2024 (51:15 Md. R. 707); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective September 18, 2023 (50:18 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215); September 18, 2023 (50:18 Md. R. 794); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 14, 2010 (37:12 Md. R. 800); December 10, 2012 (39:24 Md. R. 1577); November 11, 2013 (40:22 Md. R. 1877); February 16, 2015 (42:3 Md. R. 316); March 28, 2016 (43:6 Md. R. 407); July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective February 26, 2018 (45:4 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted effective April 4, 2022 (49:7 Md. R. 466); amended effective August 5, 2024 (51:14 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 5, 2024 (51:15 Md. R 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective August 12, 1996 (23:16 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 1, 1993 (20:10 Md. R. 852); January 12, 2009 (36:1 Md. R. 21); June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 18, 2023 (50:18 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, D adopted effective May 9, 2005 (32:9 Md. R. 849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, D amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C adopted effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective September 18, 2023 (50:18 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective September 18, 2023 (50:18 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D amended effective September 18, 2023 (50:18 Md. R. 794)</annotation> </annotations> </chapter> <chapter num="37" heading="Family Planning Program Eligibility"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter governs the determination of eligibility for the Family Planning Program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Applicant.</text> <paragraph num="(a)"> <text>“Applicant” means an individual whose written, signed application for the Family Planning Program has been submitted to the Department but has not received final action.</text> </paragraph> <paragraph num="(b)"> <text>“Applicant” includes a non-pregnant individual whose application is submitted through an authorized representative.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Application” means the filing of a written and signed application form for the Family Planning Program at the Department or its designee.</text> </paragraph> <paragraph num="(3)"> <text>“Application date” means the date on which a written, signed application is received by the Department.</text> </paragraph> <paragraph num="(4)"> <text>“Application form” means the form designated by the Department to be completed, signed, and submitted to the Department, or its designee, as an official application for the Family Planning Program.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, relative or other individual designated in writing to the Department, authorized concerning the applicant’s or participant’s eligibility under this chapter to:</text> <paragraph num="(a)"> <text>Act on an applicant’s or participant’s behalf; and</text> </paragraph> <paragraph num="(b)"> <text>Assist with the application or redetermination process and in other communication with the Department.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Continuing eligibility” means a participant’s eligibility for a subsequent certification period after the current certification period, based on the Department’s redetermination of eligibility with respect to an individual who is enrolled in Family Planning on the application date.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“Determination” means a decision regarding an applicant's eligibility for the Family Planning Program.</text> </paragraph> <paragraph num="(9)"> <text>“Family Planning Program” means the program established in Health–General Article, §15-103 et seq., Annotated Code of Maryland to provide services related to contraceptive care to individuals who meet the eligibility requirements specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(10)"> <text>“Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2).</text> </paragraph> <paragraph num="(11)"> <text>“Household” means a MAGI household unit as set forth in COMAR 10.09.24.06-1.</text> </paragraph> <paragraph num="(12)"> <text>“Income” has the meaning stated in COMAR 10.09.24.02B.</text> </paragraph> <paragraph num="(13)"> <text>“Inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5.</text> </paragraph> <paragraph num="(14)"> <text>“MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility under the Affordable Care Act.</text> </paragraph> <paragraph num="(15)"> <text>“MAGI coverage groups” has the meaning stated in COMAR 10.09.24.03A.</text> </paragraph> <paragraph num="(16)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq.</text> </paragraph> <paragraph num="(17)"> <text>“Participant” means an individual who is determined eligible for the Family Planning Program.</text> </paragraph> <paragraph num="(18)"> <text>Public Institution.</text> <paragraph num="(a)"> <text>“Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control.</text> </paragraph> <paragraph num="(b)"> <text>“Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Redetermination” means a determination regarding the eligibility of a participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Eligibility for Family Planning Program Coverage."> <paragraph num="A."> <text>In order to be determined eligible for benefits under the Family Planning Program, an applicant:</text> <paragraph num="(1)"> <text>Shall:</text> <paragraph num="(a)"> <text>Have a household income that does not exceed 250 percent of the federal poverty level; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the following requirements:</text> <paragraph num="(i)"> <text>Citizenship requirements in COMAR 10.09.24.05;</text> </paragraph> <paragraph num="(ii)"> <text>Identity requirements in COMAR 10.09.24.05-1AF and H; and</text> </paragraph> <paragraph num="(iii)"> <text>Residency requirements in COMAR 10.09.24.05-3.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>May not be:</text> <paragraph num="(a)"> <text>Pregnant;</text> </paragraph> <paragraph num="(b)"> <text>Determined eligible for another Medical Assistance Program; or</text> </paragraph> <paragraph num="(c)"> <text>An incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5A.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant whose income does not exceed 250 percent of the federal poverty level and is determined eligible for pregnancy or postpartum coverage under COMAR 10.09.24 shall be:</text> <paragraph num="(1)"> <text>Enrolled for 1 year without filing a separate application after pregnancy related period of eligibility ends; and</text> </paragraph> <paragraph num="(2)"> <text>Redetermined for eligibility based on the criteria in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Family Planning Program Presumptive Eligibility."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Applicant” means an individual who has applied for presumptive eligibility at a participating family planning clinic.</text> </paragraph> <paragraph num="(b)"> <text>“Application” means the presumptive eligibility application.</text> </paragraph> <paragraph num="(c)"> <text>“Authorized representative” has the meaning stated in COMAR 10.01.04.01.</text> </paragraph> <paragraph num="(d)"> <text>“Determination” means a decision regarding an applicant’s presumptive eligibility.</text> </paragraph> <paragraph num="(e)"> <text>“Family planning clinic” means an entity that:</text> <paragraph num="(i)"> <text>Provides family planning services under a written agreement with the Maryland Department of Health, Prevention and Health Promotion Administration; and</text> </paragraph> <paragraph num="(ii)"> <text>Is approved to perform family planning presumptive eligibility determinations.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>“Former foster care” means an individual who:</text> <paragraph num="(i)"> <text>Is younger than 26 years old;</text> </paragraph> <paragraph num="(ii)"> <text>Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and</text> </paragraph> <paragraph num="(iii)"> <text>Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance, upon attaining age 18 and leaving out-of-home placement or upon attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>“Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses.</text> </paragraph> <paragraph num="(h)"> <text>“Maryland Family Planning Program Delegate Service Site” means an entity that provides family planning services under a written agreement with the Department.</text> </paragraph> <paragraph num="(i)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals.</text> </paragraph> <paragraph num="(j)"> <text>“Presumptive eligibility” means temporary eligibility for Family Planning Program services as determined by family planning clinics in accordance with this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements.</text> <paragraph num="(1)"> <text>A family planning clinic qualified to make presumptive eligibility decisions shall:</text> <paragraph num="(a)"> <text>Participate as a Medical Assistance Program provider in good standing; and</text> </paragraph> <paragraph num="(b)"> <text>Sign an agreement prepared by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agreement under §B(1)(b) of this regulation shall require that the family planning clinic:</text> <paragraph num="(a)"> <text>Comply with Departmental policies and procedures supplied by the Department at the time of application and training;</text> </paragraph> <paragraph num="(b)"> <text>Meet accuracy and timeliness standards established by the Department;</text> </paragraph> <paragraph num="(c)"> <text>Submit a list to the Department of family planning clinic employees who will attend presumptive eligibility training developed by the Department;</text> </paragraph> <paragraph num="(d)"> <text>Prohibit employees who have not attended required trainings from making presumptive eligibility decisions; and</text> </paragraph> <paragraph num="(e)"> <text>Report all requested information on a form designated by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Before assisting an applicant in filing a presumptive eligibility application, the family planning clinic employee shall:</text> <paragraph num="(a)"> <text>Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Medical Assistance Program;</text> </paragraph> <paragraph num="(b)"> <text>Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application; and</text> </paragraph> <paragraph num="(c)"> <text>Determine that the applicant:</text> <paragraph num="(i)"> <text>Has not had a prior family planning presumptive eligibility period within the last 12 months;</text> </paragraph> <paragraph num="(ii)"> <text>Is not pregnant; or</text> </paragraph> <paragraph num="(iii)"> <text>Is not actively enrolled in the Medical Assistance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The family planning clinic employee shall fill out the presumptive eligibility application based on information supplied by the applicant.</text> </paragraph> <paragraph num="(5)"> <text>The family planning clinic employee shall make a presumptive eligibility decision and submit the presumptive eligibility application by applying §D of this regulation and the following information obtained pursuant to §C of this regulation:</text> <paragraph num="(a)"> <text>Residency;</text> </paragraph> <paragraph num="(b)"> <text>Citizenship;</text> </paragraph> <paragraph num="(c)"> <text>Family size and composition; and</text> </paragraph> <paragraph num="(d)"> <text>Gross family income.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The family planning clinic employee shall inform the individual in writing of the family planning clinic’s presumptive eligibility decision, which shall include an explanation of the presumptive eligibility period.</text> </paragraph> <paragraph num="(7)"> <text>The family planning clinic shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage.</text> </paragraph> <paragraph num="(8)"> <text>The family planning clinic shall:</text> <paragraph num="(a)"> <text>Keep all written and signed presumptive eligibility applications on file for 6 years; and</text> </paragraph> <paragraph num="(b)"> <text>Make the file available to the Department upon request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Presumptive Eligibility Criteria.</text> <paragraph num="(1)"> <text>An individual shall apply for presumptive eligibility through a participating family planning clinic.</text> </paragraph> <paragraph num="(2)"> <text>An individual who applies for presumptive eligibility shall attest to:</text> <paragraph num="(a)"> <text>The citizenship requirements in COMAR 10.09.24.05;</text> </paragraph> <paragraph num="(b)"> <text>The residency requirements in COMAR 10.09.24.05-3;</text> </paragraph> <paragraph num="(c)"> <text>The individual’s pregnancy status;</text> </paragraph> <paragraph num="(d)"> <text>The individual’s family size; and</text> </paragraph> <paragraph num="(e)"> <text>The gross monthly income of the individual’s household.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Presumptive eligibility may be established for individuals who meet the Family Planning Program eligibility requirements in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Limitations. Presumptive eligibility may not be granted to an individual who:</text> <paragraph num="(1)"> <text>Is pregnant;</text> </paragraph> <paragraph num="(2)"> <text>Is currently enrolled in the Medical Assistance Program;</text> </paragraph> <paragraph num="(3)"> <text>Had a prior presumptive eligibility period during the last 12 months;</text> </paragraph> <paragraph num="(4)"> <text>Does not meet the income requirements stated in Regulation .03 of this chapter ;</text> </paragraph> <paragraph num="(5)"> <text>Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or</text> </paragraph> <paragraph num="(6)"> <text>Does not meet the citizenship requirements stated in COMAR 10.09.24.05.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Coverage Span.</text> <paragraph num="(1)"> <text>Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible.</text> </paragraph> <paragraph num="(2)"> <text>Presumptive eligibility ends on the earlier of:</text> <paragraph num="(a)"> <text>The day the individual is determined eligible for Medical Assistance; or</text> </paragraph> <paragraph num="(b)"> <text>The last day of the month following the month in which the family planning clinic determined presumptive eligibility, if an individual:</text> <paragraph num="(i)"> <text>Is found ineligible for Medical Assistance; or</text> </paragraph> <paragraph num="(ii)"> <text>Failed to apply for Medical Assistance.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Presumptive Eligibility Appeal Rights. An individual or an organization does not have appeal rights for presumptive eligibility determinations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application."> <text>For individuals not described in .03B of this chapter, application for Family Planning Program services will be conducted pursuant to the provisions of COMAR 10.09.24.04.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Consideration of Income."> <text>Determination of an applicant’s income for purposes of the Family Planning Program shall be determined under the household provisions of COMAR 10.09.24.06-1 and the income provisions applicable to MAGI household units of COMAR 10.09.24.07.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Determining Financial Eligibility."> <text>An applicant is financially eligible for the Family Planning Program if the applicant's MAGI household income as determined under COMAR 10.09.24.06-1 and .07 does not exceed 250 percent of the federal poverty level.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Certification Periods."> <paragraph num="A."> <text>For a participant, certification for initial eligibility begins not sooner than the first day of the month of application.</text> </paragraph> <paragraph num="B."> <text>A participant’s eligibility under Regulation .03 of this chapter will end as of the:</text> <paragraph num="(1)"> <text>End of a 12 month certification period;</text> </paragraph> <paragraph num="(2)"> <text>Date eligibility is determined in another Medicaid coverage group;</text> </paragraph> <paragraph num="(3)"> <text>Date the participant ceases to qualify under the requirements of Regulation .03A of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Beginning of the month in which the participant is enrolled in Medicare; or</text> </paragraph> <paragraph num="(5)"> <text>Date a participant becomes an inmate in a public institution.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Covered Services."> <text>A Family Planning Program recipient shall be entitled to services as stated in COMAR 10.09.58.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Post–Eligibility Requirements."> <text>Post-eligibility requirements for the Family Planning Program are set forth at COMAR 10.09.24.12.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Hearings."> <text>The procedures for the Program granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Fraud and Abuse."> <text>The requirements relating to fraud and abuse under COMAR 10.09.24.14 and COMAR 10.09.24.14-1 shall apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Adjustments and Recoveries."> <text>The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, excluding COMAR 10.09.24.15A(2)—(3) and COMAR 10.09.24.15A(3), shall apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103(a), and 15-140, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.15 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 13, 2020 (47:1 Md. R. 12)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 9, 2025 (52:11 Md. R. 532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective February 22, 2021 (48:4 Md. R. 176)</annotation> </annotations> </chapter> <chapter num="38" heading="Healthy Start Program"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Dietitian or nutritionist” means an individual who:</text> <paragraph num="(a)"> <text>Meets the licensing requirements in Regulation .02D of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Meets the conditions of participation in Regulation .03A and D of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Has a provider agreement with the Department as a Program provider of dietary and nutrition services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Enriched maternity service” means direct counseling, educational, case coordination, and referral services provided to a pregnant or postpartum recipient by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife during the prenatal or postpartum visit.</text> </paragraph> <paragraph num="(4)"> <text>“Family support center” means a community-based and operated center which provides parenting education, health education, child development assessment services, education and job skill development services, and social support services to families.</text> </paragraph> <paragraph num="(5)"> <text>“Healthy Start High-Risk Nutrition Instrument” means the form designated by the Department for the purpose of identifying pregnant participants in need of high-risk nutrition counseling services.</text> </paragraph> <paragraph num="(6)"> <text>“Healthy Start Prenatal Risk Assessment Instrument” means the form furnished by the Department to the provider for the purposes of documenting the results of the prenatal risk assessment and developing the participant's plan of care.</text> </paragraph> <paragraph num="(7)"> <text>“Healthy Start Program” means a program designed to identify and address medical, nutritional, and psychosocial predictors of poor birth outcomes and poor child health by providing enhanced prenatal and postpartum services to pregnant and postpartum recipients.</text> </paragraph> <paragraph num="(8)"> <text>“High-risk nutrition counseling services” means educational services provided to nutritionally high-risk pregnant participants by a dietitian or nutritionist.</text> </paragraph> <paragraph num="(9)"> <text>“Local health department” means the local agency responsible for ensuring the availability of basic public health services in each local jurisdiction, and for administering and enforcing certain State and local health laws and regulations.</text> </paragraph> <paragraph num="(10)"> <text>“Maternal and Child Health Services Block Grant” means funds allotted by the federal government under Title V of the Social Security Act.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(12)"> <text>“Nurse” means an individual who is licensed as a registered nurse in the state in which services are provided.</text> </paragraph> <paragraph num="(13)"> <text>“Nurse midwife” means an individual who:</text> <paragraph num="(a)"> <text>Meets the licensing requirements of Regulation .02A of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Meets the conditions of participation in Regulation .03A—C of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Has a provider agreement with the Department as a Program provider of nurse midwife services.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Participant” means a pregnant or postpartum recipient who:</text> <paragraph num="(a)"> <text>Enters the Healthy Start Program during a medically verified pregnancy, or up to 60 days after delivery;</text> </paragraph> <paragraph num="(b)"> <text>May continue in the program receiving postpartum family planning services up to 60 days after the delivery; and</text> </paragraph> <paragraph num="(c)"> <text>Elects to receive the services available under these regulations.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Physician” means a doctor of medicine or osteopathy who:</text> <paragraph num="(a)"> <text>Is licensed to practice medicine in the state in which services are provided;</text> </paragraph> <paragraph num="(b)"> <text>Has a provider agreement with the Department as a Program provider of physician services; and</text> </paragraph> <paragraph num="(c)"> <text>Meets the conditions of participation in Regulation .03A—C of this chapter.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(17)"> <text>“Provider” means a qualified provider of services under the Healthy Start Program who meets the conditions of participation in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(18)"> <text>“Provider agreement” means a contract between the Department and the provider.</text> </paragraph> <paragraph num="(19)"> <text>“Recipient” means an individual who is certified for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(20)"> <text>“Risk assessment—plan of care” means a package of services provided to a pregnant participant by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife, to include:</text> <paragraph num="(a)"> <text>A comprehensive risk assessment appraising the participant's medical history and current health, nutritional, psychological, and social status; and</text> </paragraph> <paragraph num="(b)"> <text>An individualized plan of care developed by the provider in consultation with the participant.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Social worker” means a person who is licensed as a social worker in the state in which services are provided.</text> </paragraph> <paragraph num="(22)"> <text>“Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)” means the federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental foods and nutrition education to pregnant and postpartum women, infants, and young children from families with low incomes who are at risk by reason of inadequate nutrition or health care.</text> </paragraph> <paragraph num="(23)"> <text>“Tertiary care maternity center” means a facility with all necessary equipment and personnel specifically trained to care for high-risk obstetrical patients and with the capability to perform all necessary tests and obstetrical procedures 24 hours a day.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>A certified nurse midwife providing Healthy Start services shall be:</text> <paragraph num="(1)"> <text>Licensed as a registered nurse in the state in which services are provided;</text> </paragraph> <paragraph num="(2)"> <text>Certified as a nurse midwife by the American College of Nurse-Midwives; and</text> </paragraph> <paragraph num="(3)"> <text>In compliance with requirements to practice nurse midwifery in the state in which services are provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Physicians providing Healthy Start services shall be licensed and legally authorized to practice medicine in the state in which the services are provided.</text> </paragraph> <paragraph num="C."> <text>Dietitians or nutritionists providing Healthy Start Program services shall be licensed in the state in which the services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Medical Assistance Program are that providers shall:</text> <paragraph num="(1)"> <text>Meet the licensure requirements in Regulation .02 of this chapter, and verify the licenses and credentials of all professionals employed by the provider;</text> </paragraph> <paragraph num="(2)"> <text>Apply for participation in the Program using an application form designated by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Be approved for participation by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Have a provider agreement with the Department in effect;</text> </paragraph> <paragraph num="(5)"> <text>Be identified as a Program provider by issuance of an individual provider number;</text> </paragraph> <paragraph num="(6)"> <text>Verify the eligibility of recipients;</text> </paragraph> <paragraph num="(7)"> <text>Accept payment by the Program as payment in full for services rendered and make no additional charge to any person for the covered services specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Provide services without discrimination on the basis of race, color, sex, national origin, marital status, physical or mental handicap;</text> </paragraph> <paragraph num="(9)"> <text>Maintain adequate records concerning service provision for a minimum of 6 years and make them available, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="(10)"> <text>Not knowingly employ or contract with any person, partnership, or corporation which has been disqualified from the Program to provide or supply service to Medical Assistance recipients, unless prior written approval has been received from the Department;</text> </paragraph> <paragraph num="(11)"> <text>Agree that claims rejected for payment due to late billing may not be billed to the participant;</text> </paragraph> <paragraph num="(12)"> <text>Not place a restriction on the recipient's right to choose the provider;</text> </paragraph> <paragraph num="(13)"> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or has not been preauthorized, the provider may not seek payment for that service from the participant; and</text> </paragraph> <paragraph num="(14)"> <text>Be selected by the participant from among qualified providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for providers of risk assessment-plan of care services are that providers shall:</text> <paragraph num="(1)"> <text>Be physicians or nurse midwives;</text> </paragraph> <paragraph num="(2)"> <text>Provide the covered services as specified in Regulation .04A of this chapter in conjunction with the pregnant participant's initial clinical prenatal visit or, otherwise, as early as possible in the pregnancy;</text> </paragraph> <paragraph num="(3)"> <text>Maintain the participant's consolidated medical record; and</text> </paragraph> <paragraph num="(4)"> <text>Agree to on-site visits by Department staff to monitor adherence to Regulation .04A of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific requirements for providers of enriched maternity services are that providers shall:</text> <paragraph num="(1)"> <text>Be physicians or nurse midwives or be under the supervision of a physician or nurse midwife;</text> </paragraph> <paragraph num="(2)"> <text>Provide the covered services as specified in Regulation .04B of this chapter in conjunction with each prenatal clinical visit of the pregnant participant and each postpartum clinical visit of the postpartum participant up to 60 days after the delivery; and</text> </paragraph> <paragraph num="(3)"> <text>Agree to on-site visits by Department staff to monitor adherence to Regulation .04B of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Specific requirements for participation in the provision of high-risk nutrition counseling services are that providers shall:</text> <paragraph num="(1)"> <text>Be a dietician or nutritionist as specified in Regulation .02C of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Contact the recipient within 10 working days of the receipt of a referral from a local health department or private prenatal care provider, unless client-related extenuating circumstances are documented; and</text> </paragraph> <paragraph num="(3)"> <text>Agree to on-site visits by Department staff to monitor adherence to Regulation .04C of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>Effective July 1, 2006, the Program shall reimburse for the following services:</text> <paragraph num="A."> <text>Risk Assessment — Plan of Care.</text> <paragraph num="(1)"> <text>One unit of service is to be reimbursed for each pregnancy.</text> </paragraph> <paragraph num="(2)"> <text>A risk assessment is an appraisal of the participant's medical history and current health, nutritional, psychological, and social status, as specified in the Healthy Start Risk Assessment Instrument. It results in the identification of problems having an impact on the outcome of the pregnancy and the subsequent health care status of the child. Based on the assessment, an appropriate plan of care is drafted and appropriate referrals are made. A copy of the completed Healthy Start Risk Assessment Instrument will be sent by the provider to the participant's local health department within 10 working days of the risk assessment.</text> </paragraph> <paragraph num="(3)"> <text>A plan of care is a description of the services and resources required to meet the participant's needs identified through the risk assessment. An individual participant's plan of care:</text> <paragraph num="(a)"> <text>Includes a description of the specific action steps necessary to address each identified need;</text> </paragraph> <paragraph num="(b)"> <text>Matches the risk status of the participant to the appropriate intensity and breadth of care;</text> </paragraph> <paragraph num="(c)"> <text>Describes the elements of care, provider or providers, and facilities to be utilized by the participant;</text> </paragraph> <paragraph num="(d)"> <text>Is subject to modification as new information arises during the course of care, including information communicated from the provider of home-visiting services;</text> </paragraph> <paragraph num="(e)"> <text>Is individualized and is developed in consultation with the participant; and</text> </paragraph> <paragraph num="(f)"> <text>Encompasses the continuum of care from the prenatal period through postpartum.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Enriched Maternity Service. A maximum of one unit of service is to be reimbursed in conjunction with each prenatal and postpartum clinical visit of the participant. The following components comprise enriched maternity service:</text> <paragraph num="(1)"> <text>Prenatal and postpartum counseling and education. This component shall include, but not be limited to, the following topics:</text> <paragraph num="(a)"> <text>The benefits and recommended schedule of prenatal visits, including routine laboratory and radiological services;</text> </paragraph> <paragraph num="(b)"> <text>Danger signs of pre-term labor, including how to differentiate between normal and abnormal signs and symptoms related to pregnancy and what actions the individual should take;</text> </paragraph> <paragraph num="(c)"> <text>Preparation for labor and delivery, including hospital registration procedures;</text> </paragraph> <paragraph num="(d)"> <text>The risks of using prescription and over-the-counter medicines during pregnancy;</text> </paragraph> <paragraph num="(e)"> <text>The risks of alcohol, tobacco, and controlled substance use;</text> </paragraph> <paragraph num="(f)"> <text>The benefits of proper dental care;</text> </paragraph> <paragraph num="(g)"> <text>The benefits of seat belt and infant car seat use;</text> </paragraph> <paragraph num="(h)"> <text>The importance of postpartum care and continuing family planning services; and</text> </paragraph> <paragraph num="(i)"> <text>Arrangements for pediatric care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nutrition education for pregnant and postpartum participants. This component shall include, but not be limited to, the following topics:</text> <paragraph num="(a)"> <text>The relation of proper nutrition to a healthy pregnancy and to a successful pregnancy outcome;</text> </paragraph> <paragraph num="(b)"> <text>Kinds and amounts of foods needed to meet nutritional requirements during pregnancy;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate weight gain during pregnancy, and components of gain;</text> </paragraph> <paragraph num="(d)"> <text>Early decisions about infant feeding practices;</text> </paragraph> <paragraph num="(e)"> <text>Benefits of, and preparation for, breastfeeding;</text> </paragraph> <paragraph num="(f)"> <text>Appropriate use of nutritional supplements, if prescribed;</text> </paragraph> <paragraph num="(g)"> <text>A postpartum woman's nutritional needs; and</text> </paragraph> <paragraph num="(h)"> <text>The benefits of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Case coordination and referral for pregnant participants. This component shall include, but not be limited to, the following activities:</text> <paragraph num="(a)"> <text>Telephone reminders before prenatal and postpartum appointments and follow-up telephone contact if the participant misses an appointment;</text> </paragraph> <paragraph num="(b)"> <text>Referral of the participant to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC);</text> </paragraph> <paragraph num="(c)"> <text>Referral of the participant to specialty services as indicated;</text> </paragraph> <paragraph num="(d)"> <text>Referral of the participant to high-risk nutrition counseling as indicated;</text> </paragraph> <paragraph num="(e)"> <text>Referral of the participant to high-risk obstetrician-gynecologist specialists, perinatologists, or other specialists based on the client's medical needs;</text> </paragraph> <paragraph num="(f)"> <text>Arrangements for hospital delivery, including delivery at a tertiary care maternity center as indicated;</text> </paragraph> <paragraph num="(g)"> <text>Arrangements for pediatric care; and</text> </paragraph> <paragraph num="(h)"> <text>Assistance in arranging for transportation to and from clinical services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>High-Risk Nutrition Counseling Services. These services are provided to nutritionally high-risk pregnant participants. Nutritionally high-risk pregnant participants are identified to the high-risk nutrition counseling services provider through the Healthy Start High-Risk Nutrition Instrument. The services include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Making a nutritional assessment including the recording and interpretation of anthropometric measurements, clinical and laboratory findings, medical conditions, nutrient and drug interactions, diet history, and psychological, social, cultural, religious, and economic factors affecting food intake;</text> </paragraph> <paragraph num="(2)"> <text>Developing a nutritional care plan based on problems identified through the assessment and integrated into the total plan of care;</text> </paragraph> <paragraph num="(3)"> <text>Determining appropriate interventions to achieve care plan goals consistent with the participant's culture, family composition, and restrictions imposed by income, transportation availability, and neighborhood food resources, including, but not limited to, counseling for food habit and behavior change, diet modifications for medical conditions, and referral for food assistance; and</text> </paragraph> <paragraph num="(4)"> <text>Monitoring and recording participant's progress toward goal achievement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Healthy Start Program may not restrict or otherwise affect:</text> <paragraph num="A."> <text>Eligibility for benefits under Title XIX of the Social Security Act or other available benefits or programs; and</text> </paragraph> <paragraph num="B."> <text>The provider's right to bill the Program for other covered program services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment of Healthy Start Program services rendered and completed shall be submitted by an approved provider according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider.</text> </paragraph> <paragraph num="(2)"> <text>Requests for payment shall be submitted on the invoice form specified by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, location, and provider number; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providers shall bill the Program for the appropriate fee specified in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>Payments shall be made:</text> <paragraph num="(1)"> <text>Only to a qualified provider for covered services rendered to a participant, as specified in these regulations;</text> </paragraph> <paragraph num="(2)"> <text>According to the applicable rate under COMAR 10.09.02 or 10.09.21 for risk assessment—plan of care, and enriched maternity service;</text> </paragraph> <paragraph num="(3)"> <text>According to methodology described in the memorandum of understanding between the Program and each local health department for risk assessment—plan of care;</text> </paragraph> <paragraph num="(4)"> <text>For high-risk nutrition counseling as follows:</text> <paragraph num="(a)"> <text>To federally qualified health centers, according to COMAR 10.09.08.05;</text> </paragraph> <paragraph num="(b)"> <text>To each local health department, according to the methodology described in the memorandum of understanding between the Program and each local health department;</text> </paragraph> <paragraph num="(c)"> <text>To Maryland qualified health centers, according to COMAR 10.09.08.06; and</text> </paragraph> <paragraph num="(d)"> <text>To all other eligible providers, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1989 (16:12 Md. R. 1337)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 amended as an emergency provision effective August 1, 1989 (16:16 Md. R. 1745); amended permanently effective November 29, 1989 (16:22 Md. R. 2364)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 20, 1992 (19:14 Md. R. 1283); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G adopted effective September 3, 1990 (17:17 Md. R. 2080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, E amended effective June 2, 1997 (24:11 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, E amended effective July 20, 1992 (19:14 Md. R. 1283)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective September 3, 1990 (17:17 Md. R. 2080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F adopted effective September 3, 1990 (17:17 Md. R. 2080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G, H adopted effective July 20, 1992 (19:14 Md. R. 1283)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended, C adopted effective July 20, 1992 (19:14 Md. R. 1283)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07—.10 repealed and new Regulations .07—.10 adopted effective June 2, 1997 (24:11 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D repealed effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E repealed effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D repealed effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective December 27, 2010 (37:26 Md. R. 1787); February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="39" heading="Doula Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Birthing parent” means the participant giving birth, who is receiving doula services throughout their pregnancy, including the prenatal, labor, and postpartum periods.</text> </paragraph> <paragraph num="(2)"> <text>“Certified doula” means a trained nonmedical professional who provides continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods and who has received a certification as approved by the Program to perform doula services.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(4)"> <text>“Doula services” means continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods, provided by a certified doula, including:</text> <paragraph num="(a)"> <text>Information about the childbirth process;</text> </paragraph> <paragraph num="(b)"> <text>Emotional and physical support provided at perinatal visits and during labor and delivery, which may include:</text> <paragraph num="(i)"> <text>Prenatal coaching;</text> </paragraph> <paragraph num="(ii)"> <text>Providing person-centered care that honors cultural and family traditions; and</text> </paragraph> <paragraph num="(iii)"> <text>Teaching and advocating on behalf of the birthing parent during appointment visits, hospitalization, and delivery;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provision of evidence-based information on general health practices pertaining to pregnancy, childbirth, postpartum care, newborn health, and family dynamics;</text> </paragraph> <paragraph num="(d)"> <text>Provision of emotional support, physical comfort measures, and information to the birthing parent to enable the birthing parent to make informed decisions pertaining to childbirth and postpartum care, and other issues throughout the perinatal period;</text> </paragraph> <paragraph num="(e)"> <text>Provision of support for the whole birth team including a birthing parent’s partner, family members, and other support persons;</text> </paragraph> <paragraph num="(f)"> <text>Provision of evidence-based information on infant feeding;</text> </paragraph> <paragraph num="(g)"> <text>Provision of general breastfeeding guidance and resources to supplement, but not in lieu of, the services of a lactation consultant;</text> </paragraph> <paragraph num="(h)"> <text>Provision of infant soothing and coping skills for the new parents; and</text> </paragraph> <paragraph num="(i)"> <text>Facilitation of access to resources that can improve birth-related outcomes, including ongoing home visiting services, transportation, housing, alcohol, tobacco and drug cessation, WIC, SNAP, and intimate partner violence resources.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Home” means the birthing parent’s place of residence in a community setting.</text> </paragraph> <paragraph num="(6)"> <text>“Labor and delivery” means the period during which the fetus, membranes, umbilical cord, and placenta are expelled from the uterus through vaginal birth or through the surgical delivery by a cesarean section.</text> </paragraph> <paragraph num="(7)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Perinatal period” means the period that encompasses both the prenatal and postpartum periods.</text> </paragraph> <paragraph num="(9)"> <text>“Postpartum period” means the period that begins immediately after childbirth up to 180 days following childbirth.</text> </paragraph> <paragraph num="(10)"> <text>“Prenatal period” means the developmental period between conception and birth.</text> </paragraph> <paragraph num="(11)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(12)"> <text>“Provider” means an individual doula or an association, partnership, or incorporated or unincorporated group of doulas certified to provide doula services that, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification Requirements."> <text>A provider shall be certified as described in the Professional Services Provider Manual and Fee Schedule under COMAR 10.09.02.07D.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a certified doula provider require that the provider:</text> <paragraph num="(1)"> <text>Maintain up-to-date certification through a doula certification program as specified in Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Shall have adequate liability insurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>Effective January 1, 2022, the Program covers doula services as defined in Regulation .01 of this chapter when the services:</text> <paragraph num="(1)"> <text>Are medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Are rendered during a birthing parent’s prenatal period, labor and delivery, and postpartum period; and</text> </paragraph> <paragraph num="(3)"> <text>If rendered via telehealth, comply with the requirements established in COMAR 10.09.49 and any other subregulatory guidance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall cover up to:</text> <paragraph num="(1)"> <text>Eight prenatal or postpartum visits; and</text> </paragraph> <paragraph num="(2)"> <text>One labor and delivery service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Doula services covered under this chapter are subject to the following limitations:</text> <paragraph num="A."> <text>One of the following providers shall be present while doula services are provided during the delivery:</text> <paragraph num="(1)"> <text>An obstetrician-gynecologist;</text> </paragraph> <paragraph num="(2)"> <text>A family medicine practitioner; or</text> </paragraph> <paragraph num="(3)"> <text>A certified nurse midwife.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Doula services furnished during labor and delivery may not be rendered via telehealth.</text> </paragraph> <paragraph num="C."> <text>Payment for doula services shall be limited to direct services provided. Expenses may not be reimbursed for items related to:</text> <paragraph num="(a)"> <text>Travel;</text> </paragraph> <paragraph num="(b)"> <text>Administrative overhead; or</text> </paragraph> <paragraph num="(c)"> <text>Ongoing certification, training, or consultation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Multiple visits are not allowed in the same day except in the following instances:</text> <paragraph num="(a)"> <text>A prenatal visit occurs earlier in the day, and a labor and delivery visit later in the day; or</text> </paragraph> <paragraph num="(b)"> <text>A labor and delivery visit occurs earlier in the day, and a postpartum doula later in the day.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment in the format designated by the Program.</text> </paragraph> <paragraph num="B."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider's customary charge to the general public. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §H of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program will pay for covered services, the lesser of:</text> <paragraph num="(1)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Program's fee schedule.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The provider may not bill the Program or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail;</text> </paragraph> <paragraph num="(4)"> <text>Professional services rendered via telehealth when services are indicated as an exclusion; or</text> </paragraph> <paragraph num="(5)"> <text>Providing a copy of a participant's medical record when requested by another provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payments for services rendered to a birthing parent shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="G."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="H."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>Unless otherwise specified, payments shall be made in 15-minute units of service.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall be reimbursed in accordance with COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Implementation Date."> <text>This chapter shall be implemented on January 1, 2022.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 21, 2022 (49:4 Md. R. 300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 24, 2024 (51:12 Md. R. 618)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H amended effective June 24, 2024 (51:12 Md. R. 618)</annotation> </annotations> </chapter> <chapter num="40" heading="Early Intervention Services Coordination"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Department as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(2)"> <text>“Developmental areas” means cognitive development, physical development (including fine and gross motor and sensory development), speech and language development, psychological development, and self-help skills.</text> </paragraph> <paragraph num="(3)"> <text>“Developmental delay” has the meaning stated in COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(4)"> <text>“Early intervention services” means services defined in COMAR 13A.13.01.03B(15) that:</text> <paragraph num="(a)"> <text>Are designed to meet the developmental needs of infants and toddlers with disabilities;</text> </paragraph> <paragraph num="(b)"> <text>Are provided under public supervision and in conformity with an IFSP; and</text> </paragraph> <paragraph num="(c)"> <text>Meet applicable State and federal standards.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Early intervention service coordination” means the coordination of services covered under this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Family” means those individuals with whom a participant resides, who are responsible for the participant, are the primary nurturing caregivers, and have assumed major, long-term roles in the infant or toddler's daily life.</text> </paragraph> <paragraph num="(7)"> <text>“Individualized Family Service Plan (IFSP)” means a participant's written plan for early intervention services which is developed or revised by a multidisciplinary team based on the results of a multidisciplinary assessment or reassessment and is documented in accordance with guidelines issued by the Maryland Infants and Toddlers Program.</text> </paragraph> <paragraph num="(8)"> <text>“Local health department” means the public health services agency in each county and Baltimore City, which receives State and local government funding to ensure that basic public health services in the areas of personal and environmental health are available in each jurisdiction.</text> </paragraph> <paragraph num="(9)"> <text>“Maryland Infants and Toddlers Program” means the program designated by the Governor under Executive Order 01.01.1988.15 to plan, develop, and implement a Statewide, coordinated, comprehensive, multidisciplinary, interagency plan for early intervention services in Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(11)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(12)"> <text>“Multidisciplinary assessment or reassessment” means the process used by a participant's multidisciplinary team to review the child's unique needs, the family's ability to assist in meeting needs related to the child's development, and the nature and extent of early intervention and other services needed by the child.</text> </paragraph> <paragraph num="(13)"> <text>“Multidisciplinary team” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the IFSP.</text> </paragraph> <paragraph num="(14)"> <text>“Parent” has the meaning stated in COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(15)"> <text>“Participant” means a federally qualified recipient:</text> <paragraph num="(a)"> <text>Who is aged birth to the beginning of the school year following the child’s fourth birthday;</text> </paragraph> <paragraph num="(b)"> <text>Whose parents have provided written consent for the use of public benefits consistent with COMAR 13A.13.01.12;</text> </paragraph> <paragraph num="(c)"> <text>Who is not receiving the same service coordination services under another Program authority; and</text> </paragraph> <paragraph num="(d)"> <text>Who is defined as a child with a developmental delay as defined in COMAR 13A.13.01.03.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Program” means the Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(17)"> <text>“Provider” means an early intervention service coordination provider.</text> </paragraph> <paragraph num="(18)"> <text>“Service coordination” means the services provided, as part of the Maryland Infants and Toddlers Program, which assists participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, mental health, financial assistance, counseling, educational, and other support services.</text> </paragraph> <paragraph num="(19)"> <text>“Service coordinator” means an individual who:</text> <paragraph num="(a)"> <text>Is utilized by the provider and chosen by the participant’s parent;</text> </paragraph> <paragraph num="(b)"> <text>Is designated to carry out the IFSP service coordination activities;</text> </paragraph> <paragraph num="(c)"> <text>Meets the requirements in Regulation .03C of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Provides the services specified in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Telehealth” has the meaning as stated in COMAR 10.09.49.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>Social workers participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland, or meet the social worker licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="B."> <text>Registered nurses participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or meet the registered nurse licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="C."> <text>Audiologists participating as service coordinators shall be licensed pursuant to COMAR 10.41.03.03, or meet the audiologist licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="D."> <text>Nutritionists or dietitians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 4, Annotated Code of Maryland, or meet the corresponding licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="E."> <text>Occupational therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland, or meet the occupational therapist licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="F."> <text>Physical therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland, or meet the physical therapist licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="G."> <text>Clinical psychologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 16, Annotated Code of Maryland, or meet the clinical psychologist licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="H."> <text>School psychologists participating as service coordinators shall be certified pursuant to COMAR 13A.12.03.08, or meet the school psychologist regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="I."> <text>Special educators participating as service coordinators shall be certified pursuant to COMAR 13A.12.01.04, or meet the special educator regulatory requirements of the state in which services are provided.</text> </paragraph> <paragraph num="J."> <text>Speech language pathologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland, or meet the speech language pathologist licensure or certification and regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="K."> <text>Professional counselors participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 15, Annotated Code of Maryland, or meet the professional counselor licensure and regulatory requirements of the state in which services are provided.</text> </paragraph> <paragraph num="L."> <text>Physicians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 14, Annotated Code of Maryland, or meet the physicians’ licensure and regulatory requirements of the state in which the services are provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that providers shall do the following, either directly through staff or by agreement:</text> <paragraph num="(1)"> <text>Meet all conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain a file on each participant which meets the Program’s requirements and which includes for each contact made by the service coordinator:</text> <paragraph num="(a)"> <text>Date and subject of contact,</text> </paragraph> <paragraph num="(b)"> <text>Person contacted,</text> </paragraph> <paragraph num="(c)"> <text>Person making the contact,</text> </paragraph> <paragraph num="(d)"> <text>Nature, content, and unit or units of service provided;</text> </paragraph> <paragraph num="(e)"> <text>Place of service; and</text> </paragraph> <paragraph num="(f)"> <text>Signature and printed name of the service coordinator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as an early intervention service coordinator are that the provider shall do the following, either directly or indirectly by agreement:</text> <paragraph num="(1)"> <text>Use qualified individuals as service coordinators;</text> </paragraph> <paragraph num="(2)"> <text>Have demonstrated expertise in providing family-centered, community-based, coordinated care to children with disabilities, with an emphasis on early intervention services;</text> </paragraph> <paragraph num="(3)"> <text>Develop the IFSP within 45 working days of referral, unless client-related extenuating circumstances are documented in accordance with COMAR 13A.13.01.07B.</text> </paragraph> <paragraph num="(4)"> <text>Have formal written policies and procedures, approved by the Department, which specifically address the provision of early intervention [services case management] service coordination to participants in accordance with the requirements of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Designate specific qualified individuals as early intervention service coordinators;</text> </paragraph> <paragraph num="(6)"> <text>Maintain on file an initial Individualized Family Service Plan for each participant, and any subsequent revised IFSPs;</text> </paragraph> <paragraph num="(7)"> <text>Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants;</text> </paragraph> <paragraph num="(8)"> <text>Maintain a current listing of medical, social, mental health, financial assistance, education, training, counseling, and other early intervention and support services available to infants and toddlers with disabilities; and</text> </paragraph> <paragraph num="(9)"> <text>Strictly safeguard the confidentiality of a participant's records, so as not to endanger the participant's and the family's legal rights, family relationships, and status in the community.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A service coordinator shall meet the following requirements:</text> <paragraph num="(1)"> <text>Be a professional who:</text> <paragraph num="(a)"> <text>Has a current license or certification, according to Regulation .02 of this chapter, in the profession most immediately relevant to a participant’s needs; and</text> </paragraph> <paragraph num="(b)"> <text>Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be a nonprofessional who:</text> <paragraph num="(a)"> <text>Has a high school diploma or its equivalency who meets Personnel Standards described in COMAR 13A.07.01.02;</text> </paragraph> <paragraph num="(b)"> <text>Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; and</text> </paragraph> <paragraph num="(c)"> <text>Participates in ongoing training offerings as specified in the interagency plan for early intervention services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program shall reimburse for the services in §§B, C, and D of this regulation, when they have been documented as necessary.</text> </paragraph> <paragraph num="B."> <text>Initial Service Coordination.</text> <paragraph num="(1)"> <text>A unit of service is defined as a completed initial Individualized Family Service Plan (IFSP) and at least one contact with the participant or the participant’s family, on the participant’s behalf.</text> </paragraph> <paragraph num="(2)"> <text>The covered services include convening and conducting a multidisciplinary team to:</text> <paragraph num="(a)"> <text>Perform a multidisciplinary assessment; and</text> </paragraph> <paragraph num="(b)"> <text>Develop an initial IFSP for a participant that identifies the:</text> <paragraph num="(i)"> <text>Participant’s needs for early intervention, medical, mental and behavioral health, social, educational, financial assistance, counseling, and other support services;</text> </paragraph> <paragraph num="(ii)"> <text>Responsibilities and rights of the participant and the family,</text> </paragraph> <paragraph num="(iii)"> <text>Provider's responsibilities, and</text> </paragraph> <paragraph num="(iv)"> <text>Resources available to provide the needed services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Administrative, supervisory, and monitoring services associated with the initial service coordination are included as a part of the service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Ongoing Service Coordination.</text> <paragraph num="(1)"> <text>Ongoing service coordination is provided following the initial service coordination.</text> </paragraph> <paragraph num="(2)"> <text>A unit of service includes all necessary covered services and at least one monthly contact with the participant’s family on the participant’s behalf via:</text> <paragraph num="(a)"> <text>Telephone call;</text> </paragraph> <paragraph num="(b)"> <text>Telehealth or in-person visit; or</text> </paragraph> <paragraph num="(c)"> <text>Written communication.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>These services include:</text> <paragraph num="(a)"> <text>Maintaining contact with a participant and the family through home visits, office visits, telephone calls, and follow-up services as necessary;</text> </paragraph> <paragraph num="(b)"> <text>Referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IFSP, and providing linkage to agreed-upon direct service providers of early intervention services;</text> </paragraph> <paragraph num="(c)"> <text>Discussing with direct service providers of early intervention services the services needed and available for the participant, determining the quality and quantity of service being provided, following up to identify any obstacles to a participant's utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the recommended services are being delivered and meet the participant's current needs;</text> </paragraph> <paragraph num="(d)"> <text>Providing a participant's family with information and direction that will assist the participant in successfully accessing and using the services recommended in the IFSP;</text> </paragraph> <paragraph num="(e)"> <text>Informing a participant's family of the participant's and the family's rights and responsibilities in regard to specific programs and resources;</text> </paragraph> <paragraph num="(f)"> <text>Conducting, with a participant's family, a periodic review of the participant's IFSP every 6 months, or more frequently if conditions warrant or the family requests a review;</text> </paragraph> <paragraph num="(g)"> <text>A periodic review accomplished at a meeting or by other means acceptable to the family and others involved in the review process, and which determines the following:</text> <paragraph num="(i)"> <text>The degree of a participant's progress toward achieving the goals established in the IFSP, and</text> </paragraph> <paragraph num="(ii)"> <text>Whether the goals or recommended services need to be revised; and</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Being available to the participant and the family on a nonscheduled basis as necessary for problem resolution and crisis management related to the participant's needs.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Administrative, supervisory, and monitoring services associated with the ongoing case management services are included as part of the service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Annual IFSP Review.</text> <paragraph num="(1)"> <text>A unit of service is defined as a completed annual IFSP review and at least one contact with the participant or the participant’s family, on the participant’s behalf.</text> </paragraph> <paragraph num="(2)"> <text>The covered services include convening and conducting a multidisciplinary team to:</text> <paragraph num="(a)"> <text>Perform a multidisciplinary reassessment of the participant's status and service needs; and</text> </paragraph> <paragraph num="(b)"> <text>Review and revise, as necessary, the participant's IFSP.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Early intervention service coordination is advisory in nature.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on a qualified participant’s option to receive early intervention service coordination.</text> </paragraph> <paragraph num="C."> <text>Early intervention service coordination does not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a participant's parent or family to select from all available services for which the participant is found to be eligible;</text> </paragraph> <paragraph num="(3)"> <text>A participant's parent or family's free choice among qualified providers, in the participant's behalf; or</text> </paragraph> <paragraph num="(4)"> <text>A provider's right to bill the Program for other covered Program services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Early intervention service coordination may not be:</text> <paragraph num="(1)"> <text>Provided as an integral and inseparable part of another covered Program service;</text> </paragraph> <paragraph num="(2)"> <text>Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan;</text> </paragraph> <paragraph num="(3)"> <text>Rendered in connection with the implementation of §1915(b) or (c) of the Social Security Act; or</text> </paragraph> <paragraph num="(4)"> <text>Delivered as part of institutional discharge planning.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement may not be made for early intervention service coordination if a participant is receiving a comparable case management service under another Program authority.</text> </paragraph> <paragraph num="F."> <text>A participant’s service coordinator may not be the participant’s parent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment of early intervention service coordination shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all claims not properly signed and completed.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall submit a request for payment on the claim form designated by the Department. A separate claim shall be submitted for each participant.</text> </paragraph> <paragraph num="(3)"> <text>The completed claim form in §A(2)B of this regulation shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, location, and provider number; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Providers shall bill the Program for the appropriate fee specified in §C of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>The Program may not make direct payment to participants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing Time Limitations. Billing time limitations shall be as set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payment shall be made:</text> <paragraph num="(1)"> <text>Only to a qualified provider for covered services rendered to a participant, as specified in these regulations;</text> </paragraph> <paragraph num="(2)"> <text>Only to one provider of early intervention service coordination rendered to a participant during a billing period; and</text> </paragraph> <paragraph num="(3)"> <text>According to the following fee-for-service schedule for early intervention service coordination:</text> <paragraph num="(a)"> <text>Initial service coordination (only one unit of service may be reimbursed per participant) ... $500;</text> </paragraph> <paragraph num="(b)"> <text>Ongoing service coordination (only one unit of service per month may be reimbursed for a participant after completion of initial service coordination or the annual IFSP review) ... $150;</text> </paragraph> <paragraph num="(c)"> <text>Annual IFSP review ... $275 per review.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal Procedures shall be as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105,, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 445 (February 22, 1991); adopted permanently effective February 18, 1991 (18:3 Md. R. 305)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 1, 1991 (18:17 Md. R. 1911); amended permanently effective November 1, 1991 (18:21 Md. R. 2308)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> </annotations> </chapter> <chapter num="41" heading="Employed Individuals with Disabilities"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to increase employment opportunities by making Medical Assistance coverage available to employed individuals with disabilities who meet:</text> <paragraph num="A."> <text>The disability criteria under Title II or XVI of the Social Security Act; and</text> </paragraph> <paragraph num="B."> <text>The nonfinancial and financial eligibility requirements established in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>Applicability of COMAR 10.09.24.02 Definitions.</text> <paragraph num="(1)"> <text>Except as provided in §A(2) of this regulation, terms used in this chapter that are not defined in §C of this regulation have the meanings stated for the same terms in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(2)"> <text>If a term's definition in COMAR 10.09.24.02 references a “local department of social services” in the context of a determination of eligibility, the words “local department of social services” in the COMAR 10.09.24.02 definition shall be replaced, for purposes of the term's meaning in this chapter, with “the Department” .</text> </paragraph> </paragraph> <paragraph num="B."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="C."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual:</text> <paragraph num="(a)"> <text>Who is not a recipient;</text> </paragraph> <paragraph num="(b)"> <text>Who has submitted to the Department an application for the Employed Individuals with Disabilities coverage group; and</text> </paragraph> <paragraph num="(c)"> <text>Whose application has not received final action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Application” means the filing with the Department of a written and signed application form for the Employed Individuals with Disabilities (EID) coverage group to establish eligibility for Medical Assistance benefits.</text> </paragraph> <paragraph num="(3)"> <text>“Application date” means the date a written and signed application form for determination or redetermination of eligibility for the EID coverage group is received by the Department.</text> </paragraph> <paragraph num="(4)"> <text>“Assistance unit” means an applicant or recipient and, when living together, the applicant's or recipient's spouse, whose eligibility for Medical Assistance benefits is determined in conjunction with each other.</text> </paragraph> <paragraph num="(5)"> <text>“Certification period” means a period of time of up to 12 months, beginning on the first day of the month in which the Department receives the application, for which the EID applicant’s or recipient’s eligibility to receive Medical Assistance benefits is certified.</text> </paragraph> <paragraph num="(6)"> <text>“Chronic hospital” has the meaning stated in COMAR 10.09.06.01B.</text> </paragraph> <paragraph num="(7)"> <text>“Continuing eligibility” means a recipient's EID eligibility for a subsequent certification period after the current certification period, based on the Department's redetermination of eligibility with respect to an individual who is enrolled in the EID coverage group on the application date.</text> </paragraph> <paragraph num="(8)"> <text>“Days” has the meaning stated in Article I, §36, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Determination” means a decision by the Department regarding an applicant's or recipient's eligibility for the EID coverage group.</text> </paragraph> <paragraph num="(11)"> <text>“Disability” means an individual's medically determinable impairment that is the basis of a determination that the individual is disabled, according to the standards set forth in §1614(a)(3) of the Social Security Act, except substantial gainful activity is not considered in determining disability.</text> </paragraph> <paragraph num="(12)"> <text>“Disabled” means having a disability.</text> </paragraph> <paragraph num="(13)"> <text>“Disregard” means a fixed monetary amount or documented expense that is deducted from countable gross income to determine countable net income.</text> </paragraph> <paragraph num="(14)"> <text>“Employed” means being engaged in employment:</text> <paragraph num="(a)"> <text>That is verifiable;</text> </paragraph> <paragraph num="(b)"> <text>That yields earnings during the period under consideration; and</text> </paragraph> <paragraph num="(c)"> <text>The earnings from which are subjected to reporting, withholding, and payment as required by law, including but not limited to individual income tax, payroll tax, estimated income tax, and withholding or payments required by the Federal Insurance Contribution Act.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Employed Individuals with Disabilities (EID)” means the Medical Assistance coverage group for employed individuals with disabilities, which is:</text> <paragraph num="(a)"> <text>Operated under the regulations of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Funded jointly by the State and the federal governments; and</text> </paragraph> <paragraph num="(c)"> <text>Administered by the Department.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Employer-sponsored insurance (ESI)” means group health insurance coverage provided wholly or partly at the expense of an applicant's, recipient's, or spouse's employer.</text> </paragraph> <paragraph num="(17)"> <text>“Employment” means working for payment either for an employer or on a self-employed basis.</text> </paragraph> <paragraph num="(18)"> <text>“Excludable” means the types of income and resources that are specified in this chapter as not countable in the determination of eligibility for the EID coverage group.</text> </paragraph> <paragraph num="(19)"> <text>“Family unit size” means the number of individuals included in an assistance unit, which is used to determine the applicable income or resource standard.</text> </paragraph> <paragraph num="(20)"> <text>“Grace period” means a period of time not longer than 6 months during which an unemployed EID recipient pays premiums and remains eligible to receive EID benefits despite failing to meet the requirement that EID recipients be employed.</text> </paragraph> <paragraph num="(21)"> <text>“Hardship” means financial adversity or misfortune significant enough that it reasonably can be expected to compromise an applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for the applicant or recipient, another member of the assistance unit, or any dependents of the applicant or recipient.</text> </paragraph> <paragraph num="(22)"> <text>“Health insurance” has the same meaning as “health insurance coverage”, as stated in COMAR 10.09.43.02B.</text> </paragraph> <paragraph num="(23)"> <text>“Initial eligibility” means the EID eligibility of an individual who is not enrolled in the EID coverage group on the application date.</text> </paragraph> <paragraph num="(24)"> <text>“Long-term care facility services” means services delivered to patients admitted to a nursing facility, chronic hospital, or a rehabilitation hospital.</text> </paragraph> <paragraph num="(25)"> <text>“Medical criteria for disability” means the criteria applied by the Social Security Administration (SSA) to determine disability under Title XVI of the Social Security Act, except for the disability criteria that consider an individual's earnings as evidence of an ability to perform substantial gainful activity.</text> </paragraph> <paragraph num="(26)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Notice of eligibility” means the written notice issued by the Department informing an applicant or recipient of:</text> <paragraph num="(a)"> <text>The Department's finding of eligibility or ineligibility; and</text> </paragraph> <paragraph num="(b)"> <text>The legal rights and obligations of the applicant or recipient associated with the Department's determination.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Nursing facility” has the meaning stated in COMAR 10.09.10.01B.</text> </paragraph> <paragraph num="(29)"> <text>“Period under consideration” means a period of 6 months, beginning on the first day of the month of the application date, for which an assistance unit's income is assessed for a determination of eligibility under this chapter.</text> </paragraph> <paragraph num="(30)"> <text>“Premium” means the monthly amount an applicant or recipient is required to pay, absent a successful claim of hardship pursuant to Regulation .07C of this chapter, as a condition of eligibility for the EID coverage group and Medical Assistance benefits.</text> </paragraph> <paragraph num="(31)"> <text>“Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Recipient” means an individual who has been determined eligible for the EID coverage group.</text> </paragraph> <paragraph num="(33)"> <text>“Redetermination” means a determination by the Department, at least every 12 months, regarding the continuing eligibility of a recipient, in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="(34)"> <text>“Rehabilitation hospital” has the same meaning as “special rehabilitation hospital”, as stated in COMAR 10.07.01.02C.</text> </paragraph> <paragraph num="(35)"> <text>“Social Security Disability Insurance (SSDI)” means a federally administered program that provides benefits to individuals with disabilities who have paid sufficient Social Security taxes to be eligible for disability insurance payments under Title II of the Social Security Act, 42 U.S.C §423 et seq.</text> </paragraph> <paragraph num="(36)"> <text>“Substantial gainful activity” has the meaning stated in 20 CFR §416.910, which the Social Security Administration applies in determining disability under Title XVI of the Social Security Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Nonfinancial Eligibility."> <paragraph num="A."> <text>The Department shall determine whether an applicant or recipient meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation.</text> </paragraph> <paragraph num="B."> <text>An applicant or participant meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation if the applicant or participant:</text> <paragraph num="(1)"> <text>Is 16 years old or older, but younger than 65 years old;</text> </paragraph> <paragraph num="(2)"> <text>Is employed, except when an unemployment grace period described under Regulation .07 of this chapter applies, and verifies employment and compliance with all applicable requirements relating to FICA, income tax reporting, withholding, and payment requirements, including, if self-employed, payment of estimated taxes, by submitting documentation such as:</text> <paragraph num="(a)"> <text>Pay stubs;</text> </paragraph> <paragraph num="(b)"> <text>A letter from the employer verifying the applicant's or recipient's employment;</text> </paragraph> <paragraph num="(c)"> <text>Bank statements showing deposits of earnings;</text> </paragraph> <paragraph num="(d)"> <text>Income tax returns;</text> </paragraph> <paragraph num="(e)"> <text>Evidence of payment of estimated taxes; or</text> </paragraph> <paragraph num="(f)"> <text>Business ledgers;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except for the consideration of substantial gainful activity, meets the definition of disability in §1614(a)(3) of the Social Security Act, as determined by:</text> <paragraph num="(a)"> <text>The Department pursuant to a disability determination process for applicants who have not had a disability determination completed by the Social Security Administration within the time period prescribed in §C(2) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>The Social Security Administration, if the applicant or recipient:</text> <paragraph num="(i)"> <text>Receives SSDI benefits; or</text> </paragraph> <paragraph num="(ii)"> <text>Has lost eligibility for SSDI or SSI for any reason other than medical improvement;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>As specified in COMAR 10.09.24:</text> <paragraph num="(a)"> <text>Meets the eligibility requirements for Medical Assistance as to:</text> <paragraph num="(i)"> <text>Citizenship; and</text> </paragraph> <paragraph num="(ii)"> <text>Residency; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is not:</text> <paragraph num="(i)"> <text>An institutionalized person;</text> </paragraph> <paragraph num="(ii)"> <text>An inmate of a public institution; or</text> </paragraph> <paragraph num="(iii)"> <text>An inpatient in an institution for mental disease; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Is not a current recipient of:</text> <paragraph num="(a)"> <text>Comprehensive Medical Assistance benefits pursuant to COMAR 10.09.24; or</text> </paragraph> <paragraph num="(b)"> <text>Benefits under the Maryland Children's Health Program pursuant to COMAR 10.09.11 or 10.09.43.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Periodic Redetermination of Disability.</text> <paragraph num="(1)"> <text>The Department shall periodically review a recipient's impairments to determine continuing disability status, consistent with §C(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Frequency of Continuing Disability Reviews. The Department may schedule the periodic disability reviews required by §C(1) of this regulation at a frequency that is consistent with the time frames set forth in federal law and regulations as specified in 20 CFR §416.989, as amended, and 20 CFR §416.990, as amended, which are incorporated by reference.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Financial Eligibility."> <paragraph num="A."> <text>Assistance Unit. An applicant's or recipient's assistance unit shall include the:</text> <paragraph num="(1)"> <text>Applicant or recipient; and</text> </paragraph> <paragraph num="(2)"> <text>Applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Consideration of Income.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) or C of this regulation, the Department shall determine, in accordance with the policies and procedures for aged, blind, or disabled coverage groups specified at COMAR 10.09.24, the countable net income of an EID applicant or participant for purposes of determining the applicable premium amount under Regulation .07 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>To determine the countable net income of an EID assistance unit, the Department shall subtract from the assistance unit's total gross income:</text> <paragraph num="(a)"> <text>The general income exclusions and disregards and the specific income exclusions and disregards for aged, blind, or disabled coverage groups specified at COMAR 10.09.24; and</text> </paragraph> <paragraph num="(b)"> <text>An amount equal to the applicant's, recipient's, or spouse's documented out-of-pocket cost of premium payments to secure current employer-sponsored insurance coverage that includes coverage of the applicant or recipient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>As a condition of eligibility for Medical Assistance benefits under this chapter, unless good cause for not doing so is shown, applicants and recipients, shall take all necessary steps to obtain any annuities, pensions, retirement, and disability benefits to which they are entitled, including, but not limited to:</text> <paragraph num="(a)"> <text>Veterans' compensation and pensions;</text> </paragraph> <paragraph num="(b)"> <text>Old Age and Survivors' Disability Insurance (OASDI) benefits;</text> </paragraph> <paragraph num="(c)"> <text>Railroad retirement benefits;</text> </paragraph> <paragraph num="(d)"> <text>Unemployment compensation; or</text> </paragraph> <paragraph num="(e)"> <text>Social Security Disability Income (SSDI).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Income Standards. Effective January 1, 2024, no income standard applies to applicants or participant under this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Consideration of Resources.</text> <paragraph num="(1)"> <text>Except as provided in this section, whether an applicant meets the resource standards for eligibility for the EID coverage group shall be determined according to the policies and procedures for aged, blind, or disabled coverage groups specified in COMAR 10.09.24.</text> </paragraph> <paragraph num="(2)"> <text>To determine the total countable resources of an applicant, the Department shall apply the general resource exclusions and specific resource exclusions for aged, blind, or disabled coverage groups specified in COMAR 10.09.24 to the total gross resources of the applicant.</text> </paragraph> <paragraph num="(3)"> <text>From the total countable resources of the applicant determined pursuant to §C(1) and (2) of this regulation, the Department shall subtract the aggregate current cash value of the applicant’s or participant’s ownership interest in any of the following types of accounts:</text> <paragraph num="(a)"> <text>401(k) retirement account;</text> </paragraph> <paragraph num="(b)"> <text>403(b) retirement account;</text> </paragraph> <paragraph num="(c)"> <text>Pension plan;</text> </paragraph> <paragraph num="(d)"> <text>Keogh plan;</text> </paragraph> <paragraph num="(e)"> <text>Individual retirement account (IRA);</text> </paragraph> <paragraph num="(f)"> <text>Independence Account; or</text> </paragraph> <paragraph num="(g)"> <text>Other retirement accounts as defined by the IRS.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For an applicant or participant to be eligible for Medical Assistance benefits under this chapter, the countable resources attributed to the applicant’s or participant’s assistance unit pursuant to §§C and D of this regulation may not exceed $10,000 for an individual.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Independence Accounts.</text> <paragraph num="(1)"> <text>Account Provisions.</text> <paragraph num="(a)"> <text>Contributions to any of the participant’s registered Independence Accounts are subject to the rules described in this section and to any policies of the respective financial institution governing the account.</text> </paragraph> <paragraph num="(b)"> <text>All contributions to the participant’s Independence Account or accounts, including interest, dividends, or other gains from the principal, shall be treated as an exempt asset for the purpose of calculating eligibility for Medical Assistance and the EID program.</text> </paragraph> <paragraph num="(c)"> <text>The purpose of an Independence Account is to allow the participant to purchase any items or services that may aid in the participant’s pursuit of personal or financial independence.</text> </paragraph> <paragraph num="(d)"> <text>The EID participant shall be the sole owner of any account registered as an Independence Account.</text> </paragraph> <paragraph num="(e)"> <text>The Department shall assess the participant’s Independence Account as a part of the verification process at redetermination for Medical Assistance. The review process shall include verifying all contributions to the participant’s Independence Account with the financial institution holding the participant’s account.</text> </paragraph> <paragraph num="(f)"> <text>The total amount a participant deposits in all independence accounts during an annual certification period may not exceed the participant’s gross earned income for that annual certification period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Independence Account Registration.</text> <paragraph num="(a)"> <text>A person shall complete an account registration form to register an applicable account as an Independence Account with the Department.</text> </paragraph> <paragraph num="(b)"> <text>A person shall re-register the Independence Account with the Department if the financial institution or other information for the Independence Account changes.</text> </paragraph> <paragraph num="(c)"> <text>The applicant or participant shall report any changes in personal or financial status that may affect the applicant’s or participant’s eligibility for Medical Assistance as described in COMAR 10.09.24.</text> </paragraph> <paragraph num="(d)"> <text>For all registered Independence Accounts, the date of account creation may be no earlier than the date an EID participant is determined eligible for Medical Assistance under this section.</text> </paragraph> <paragraph num="(e)"> <text>For all registered Independence Accounts, the funds in the Independence Account shall be held separate from the participant’s non-exempt assets.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Requirements — Determination and Redetermination of Eligibility."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>To any individual requesting information, the Department shall provide oral or written information about:</text> <paragraph num="(a)"> <text>EID eligibility requirements;</text> </paragraph> <paragraph num="(b)"> <text>The coverage, scope, and related services of the Medical Assistance Program; and</text> </paragraph> <paragraph num="(c)"> <text>Applicants' and recipients' rights and obligations under the Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall issue an EID application form to any individual upon request.</text> </paragraph> <paragraph num="(3)"> <text>An applicant or recipient may apply for a determination or a redetermination of eligibility for the EID coverage group by submitting to the Department:</text> <paragraph num="(a)"> <text>The application form designated by the Department and signed in accordance with the signature requirements of COMAR 10.09.24;</text> </paragraph> <paragraph num="(b)"> <text>The social security numbers of each member of the assistance unit, in accordance with §A(5) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Signed consent forms as specified in §A(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Consent Forms. An applicant or recipient, or, if necessary and consistent with the signature requirements specified in COMAR 10.09.24, a representative or other individual acting on behalf of the applicant or recipient, shall sign consent forms as needed to authorize the Department's verification of information needed to establish eligibility through sources such as employers, banks, and public or private agencies.</text> </paragraph> <paragraph num="(5)"> <text>Social Security Number.</text> <paragraph num="(a)"> <text>As required in COMAR 10.09.24 for each assistance unit member requesting benefits under this chapter, an applicant or recipient shall:</text> <paragraph num="(i)"> <text>Provide the Department with the individual's Social Security number; or</text> </paragraph> <paragraph num="(ii)"> <text>Verify that the individual has applied to the Social Security Administration for a Social Security card.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An applicant's or recipient's failure to meet the requirements of §A(5)(a) of this regulation shall result in a determination of ineligibility under this chapter.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An applicant or recipient shall provide to the Department information and verifications needed for the determination of all elements of nonfinancial, income, and resource eligibility, including but not limited to information relating to health insurance coverage or potential third-party payments.</text> </paragraph> <paragraph num="(7)"> <text>Additional Information Requirements. An applicant or recipient shall, at the Department's request:</text> <paragraph num="(a)"> <text>Be available for and participate in an interview; and</text> </paragraph> <paragraph num="(b)"> <text>Answer questions and provide information relevant to:</text> <paragraph num="(i)"> <text>The applicant's eligibility for the EID coverage group; or</text> </paragraph> <paragraph num="(ii)"> <text>The recipient's continuing eligibility for the EID coverage group.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>An individual temporarily absent from the State who intends to return to the State:</text> <paragraph num="(a)"> <text>May apply to the Department by mail for the EID coverage group; and</text> </paragraph> <paragraph num="(b)"> <text>To establish eligibility for the EID coverage group, shall:</text> <paragraph num="(i)"> <text>Demonstrate continued residency in the State; and</text> </paragraph> <paragraph num="(ii)"> <text>Meet all technical and financial requirements of eligibility under this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>An applicant or recipient shall cooperate and assist with the Department's eligibility determination or redetermination process under this chapter, including but not limited to the requirements of §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Maintain a case record for the applicant or recipient, including documentation of all required elements of eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each assistance unit member;</text> </paragraph> <paragraph num="(3)"> <text>Verify all factors of eligibility under this chapter for each assistance unit member applying for the EID coverage group; and</text> </paragraph> <paragraph num="(4)"> <text>Restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the EID coverage group of the Medical Assistance program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Time Standards."> <paragraph num="A."> <text>Time Standards for the Department.</text> <paragraph num="(1)"> <text>Disability Determined by Social Security Administration. With respect to an application submitted by an individual determined to be disabled as provided in Regulation .03B(3)(b) of this chapter, unless the time standard is extended pursuant to §D of this regulation, the Department shall, not later than 30 days from the application date:</text> <paragraph num="(a)"> <text>Complete its determination or redetermination of eligibility, subject to any premium payment required by Regulation .07 of this chapter, and issue a written notice that satisfies the requirements of Regulation .08B of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Determine that it cannot complete its eligibility determination without additional information or verifications, and issue a written notice that informs the applicant or recipient of:</text> <paragraph num="(i)"> <text>The information and verifications required to determine or redetermine eligibility; and</text> </paragraph> <paragraph num="(ii)"> <text>The due dates for the Department's eligibility determination and for the applicant's or recipient's provision of the additional information and verifications requested by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>No Disability Determination by Social Security Administration. Unless the time standard is extended pursuant to §D of this regulation with respect to an applicant who has had no determination of disability or continuing disability completed by the Social Security Administration within the time frame prescribed by Regulation .03C(2) of this chapter, the Department shall complete the requirements specified in §A(1)(a) or (b) of this regulation not later than 90 days from the application date.</text> </paragraph> <paragraph num="(3)"> <text>Time Standard for Redeterminations. Before the beginning of a new certification period, the Department shall:</text> <paragraph num="(a)"> <text>Issue a redetermination form to a recipient at least 60 days before the end of the current certification period; and</text> </paragraph> <paragraph num="(b)"> <text>Perform a redetermination of a recipient's eligibility, subject to any premium payment required by Regulation .07 of this chapter, for the EID coverage group.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Time Standards for Applicants and Recipients.</text> <paragraph num="(1)"> <text>Unless the time standard is extended pursuant to §D of this regulation, the applicant or recipient shall, within the time standards specified in §B(2)—(4) of this regulation, provide to the Department:</text> <paragraph num="(a)"> <text>The completed and signed application required by Regulation .05A(3) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The information and verifications, if any, requested by the Department pursuant to §A(1)(b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department's request for information or verification is part of the application packet, an applicant or recipient shall provide the signed and completed application and supporting information and materials specified in Regulation .05A(3) of this chapter to the Department early enough for the Department to meet the 30-day time standard specified in §A of this regulation for completion, subject to any premium payment required by Regulation .07 of this chapter, of an eligibility determination or redetermination.</text> </paragraph> <paragraph num="(3)"> <text>If the Department's request is made after the application date, an applicant or recipient shall provide the requested information and verifications to the Department within 10 days of the date of the Department's notice pursuant to §A(1)(b) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>For redeterminations, the recipient shall provide to the Department, by the last day of the current certification period, all materials and information required by §B(1)—(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Time for Payment of Premium.</text> <paragraph num="(1)"> <text>Unless a claim of hardship is raised pursuant to Regulation .07C of this chapter, an applicant or recipient shall submit, within the time allowed by §B of this regulation, the premium required by Regulation .07A of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If a claim of hardship raised pursuant to Regulation .07C of this chapter is denied by the Department, the applicant or recipient to whom Regulation .07C(3) of this chapter applies shall pay the premium required by Regulation .07A of this chapter within 10 days of the date of the Department’s notice pursuant to Regulation .07C(2) of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Extension of Time Standards.</text> <paragraph num="(1)"> <text>The Department shall extend the time standards specified in §B of this regulation if:</text> <paragraph num="(a)"> <text>The applicant or recipient is actively attempting to establish eligibility but has been unable to provide the required information or verifications due to circumstances beyond the applicant's or recipient's control; or</text> </paragraph> <paragraph num="(b)"> <text>There is an administrative delay or emergency beyond the control of the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the circumstances described in §D(1) of this regulation are present:</text> <paragraph num="(a)"> <text>The Department shall document in the applicant's or recipient's record the reason for the delay; and</text> </paragraph> <paragraph num="(b)"> <text>The extension of time shall continue as long as the requirements of §D(1) of this regulation are met.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Effect of Noncompliance with Time Standards. The Department shall deny the application for the EID coverage group and issue a notice of ineligibility or termination pursuant to Regulation .08C of this chapter if:</text> <paragraph num="(1)"> <text>The applicant or recipient fails to meet the timeliness requirements of §B of this regulation without the circumstances set forth in §D(1) of this regulation being present; or</text> </paragraph> <paragraph num="(2)"> <text>The time standard for the applicant's or recipient's submission of information and verifications set forth in §B of this regulation initially was extended pursuant to §D(1) of this regulation, but the requirements of §D(1) of this regulation are no longer met.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The standards of timeliness for acting on applications may not be used:</text> <paragraph num="(1)"> <text>To deny eligibility except as provided in §E of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>As a waiting period for EID enrollment of eligible individuals.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Withdrawal and Reactivation of Application.</text> <paragraph num="(1)"> <text>An individual who has filed an application for the EID coverage group with the Department may voluntarily withdraw the application at any time.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has withdrawn an application for the EID coverage group may not reactivate the application except as provided in COMAR 10.09.24.</text> </paragraph> <paragraph num="(3)"> <text>If an applicant or recipient withdraws a pending application, the application form shall remain the property of the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Premium."> <paragraph num="A."> <text>Submission of Premium.</text> <paragraph num="(1)"> <text>Unless an exception under §A(2) of this regulation applies or a timely claim of hardship is raised pursuant to §C of this regulation, an applicant or recipient shall, as a condition of eligibility for the EID coverage group, pay the premium specified in §A(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Limitation of Premium Requirement.</text> <paragraph num="(a)"> <text>An applicant or recipient with income at or below the federal poverty level is not required to pay a premium as a condition of eligibility in the EID coverage group.</text> </paragraph> <paragraph num="(b)"> <text>With respect to an applicant determined eligible subject to the requirements of §A(3) of this regulation, the Department shall waive the premium payment before the notice of eligibility for a period not to exceed 6 months if such notice of eligibility is delayed by factors beyond the applicant's control.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant or participant whose assistance unit has income:</text> <paragraph num="(a)"> <text>Above the federal poverty level, but at or below 200 percent of the federal poverty level, shall pay a monthly premium of $25;</text> </paragraph> <paragraph num="(b)"> <text>Above 200 percent, but at or below 250 percent of the federal poverty level, shall pay a monthly premium of $40;</text> </paragraph> <paragraph num="(c)"> <text>Above 250 percent, but at or below 300 percent of the federal poverty level, shall pay a monthly premium of $55;</text> </paragraph> <paragraph num="(d)"> <text>Above 300 percent, but at or below 450 percent of the federal poverty level, shall pay a monthly premium of 4 percent of the monthly net countable income determined under Regulation .04B of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Above 450 percent, but at or below 600 percent of the federal poverty level, shall pay a monthly premium of 5 percent of the monthly net countable income determined under Regulation .04B of this chapter; or</text> </paragraph> <paragraph num="(f)"> <text>Above 600 percent of the federal poverty level, shall pay a monthly premium of 7.5 percent of the monthly net countable income determined under Regulation .04B of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Request for Payment. With respect to an applicant or recipient determined eligible subject to the requirements of §A(3) of this regulation, the Department shall issue a request for payment of the applicable premium, indicating that the applicant or recipient shall pay the amount specified within 30 days of the date the Department mailed the request for payment.</text> </paragraph> <paragraph num="(5)"> <text>An applicant or recipient to whom §A(3) of this regulation applies shall, within 30 days of the Departments request for payment pursuant to Regulation §A(4) of this regulation:</text> <paragraph num="(a)"> <text>Pay the full premium due as specified in the request for payment issued pursuant to §A(4) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Submit a claim of hardship as authorized by §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Upon request by the recipient, the Department shall approve an unemployment grace period, not to exceed 6 months within a 12-month period, provided the recipient:</text> <paragraph num="(a)"> <text>Has unemployment due to medical reasons or involuntary job loss;</text> </paragraph> <paragraph num="(b)"> <text>Is otherwise eligible for EID; and</text> </paragraph> <paragraph num="(c)"> <text>Continues to pay the premium during the unemployment grace period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Nonpayment of Premium.</text> <paragraph num="(1)"> <text>If an applicant who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall:</text> <paragraph num="(a)"> <text>Determine the applicant is not eligible for the EID coverage group; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a denial notice as required by Regulation .08C(1) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If recipient who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall:</text> <paragraph num="(a)"> <text>Determine the recipient is not eligible for the EID coverage group;</text> </paragraph> <paragraph num="(b)"> <text>Issue a termination notice as required by Regulation .08C(2) of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Refer the recipient to the Central Collection Unit.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant or recipient whose eligibility is denied or terminated due to failure to pay the premium as specified in §A(4) of this regulation may not be reenrolled in the EID coverage group until the applicant or recipient pays all monies due to the Department in full.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Hardship.</text> <paragraph num="(1)"> <text>If the applicant or recipient suffers financial adversity or misfortune so severe that payment of the premium would compromise the applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for members of the assistance unit or other legal dependents of the applicant or recipient, the applicant or recipient may submit a claim of hardship, specifying the underlying circumstances, to the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall evaluate the claim of hardship and notify the applicant or recipient of its decision within 30 days of the Department's receipt of the written claim of hardship.</text> </paragraph> <paragraph num="(3)"> <text>If the Department determines that the applicant or recipient's claim of hardship is without merit, the applicant or recipient shall pay the applicable premium within 10 days after the date the Department's notice is issued pursuant to §C(2) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Determination, Notice, and Certification Period."> <paragraph num="A."> <text>Department's Determination. Based on the information presented, the Department shall determine whether an applicant or recipient is or is not eligible for the EID coverage group under this chapter.</text> </paragraph> <paragraph num="B."> <text>Finding of Eligibility or Continuing Eligibility.</text> <paragraph num="(1)"> <text>Notice of Initial Eligibility. If the Department determines that an applicant is eligible, subject to the requirements of Regulation .07A of this chapter, for the EID coverage group, the Department shall issue to the applicant written notice that includes:</text> <paragraph num="(a)"> <text>A statement of the finding of eligibility, as applicable, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Notice of the right to request a hearing pursuant to Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notice of Continuing Eligibility. If the Department determines that a recipient qualifies for continuing eligibility for the EID coverage group, the Department shall issue to the recipient a written notice that includes:</text> <paragraph num="(a)"> <text>A statement of the finding of continuing eligibility, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>A notice of the right to request a hearing pursuant to Regulation .13 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Denial or Termination.</text> <paragraph num="(1)"> <text>Applicant—Denial Notice. If the Department determines that an applicant is not eligible for the EID coverage group, the Department shall issue to the applicant a written denial notice that includes:</text> <paragraph num="(a)"> <text>A statement of the Department's finding for the EID coverage group;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the finding;</text> </paragraph> <paragraph num="(c)"> <text>The regulation supporting the finding; and</text> </paragraph> <paragraph num="(d)"> <text>Notice of the right to request a hearing pursuant to Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Recipient—Notice of Termination. If the Department finds that a recipient is no longer eligible for the EID coverage group, the Department shall issue to the recipient a written notice of termination that includes:</text> <paragraph num="(a)"> <text>A statement of the Department's finding that the recipient is no longer eligible for the EID coverage group;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the finding;</text> </paragraph> <paragraph num="(c)"> <text>The regulation supporting the finding; and</text> </paragraph> <paragraph num="(d)"> <text>Notice of the right to request a hearing pursuant to Regulation .13 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Grounds for Department's Denial or Termination.</text> <paragraph num="(1)"> <text>If the Department finds one or more of the reasons for denial or termination listed in §D(2) of this regulation with respect to an applicant or recipient, the Department shall determine that:</text> <paragraph num="(a)"> <text>An applicant is not eligible for the EID coverage group and issue a notice of denial as specified in §C(1) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>A recipient is no longer eligible for the EID coverage group and issue a notice of termination as specified in §C(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Grounds for denial or termination from the EID coverage group shall include that an applicant or recipient:</text> <paragraph num="(a)"> <text>Does not meet, or no longer meets, the EID eligibility criteria for:</text> <paragraph num="(i)"> <text>Nonfinancial eligibility, as specified in Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>Financial eligibility, as specified in Regulation .04 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Did not submit, within the time standard specified in Regulation .06B of this chapter:</text> <paragraph num="(i)"> <text>A complete application, signed by the applicant as required by Regulation .05A(3) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>All information and verifications requested by the Department pursuant to Regulation .05A(3)—(7) of this chapter, to determine the applicant’s or recipient’s eligibility for the EID coverage group;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Did not cooperate with the Department’s eligibility determination process as required by Regulation .05A(9) of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Did not:</text> <paragraph num="(i)"> <text>Pay the premium required by Regulation .07A of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>Submit a claim of hardship that was approved by the Department pursuant to Regulation .07C of this chapter;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Did not comply with the posteligibility requirements specified in Regulation .09B and C of this chapter; or</text> </paragraph> <paragraph num="(f)"> <text>Died.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Certification Period.</text> <paragraph num="(1)"> <text>A recipient's certification period for initial eligibility shall begin on the first day of the month in which the Department receives the application.</text> </paragraph> <paragraph num="(2)"> <text>For a recipient approved by the Department for continuing eligibility, the next certification period shall begin on the first day of the month immediately following the month in which the previous certification period ends.</text> </paragraph> <paragraph num="(3)"> <text>Unless the recipient is terminated before the end of the certification period due to a change in circumstances or other reason for ineligibility, a recipient’s certification period ends, except as provided in §§D(2)(f) and E(4) of this regulation, on the last day of the current 12-month eligibility period.</text> </paragraph> <paragraph num="(4)"> <text>A recipient's certification period may be extended if the Department requires additional time to complete its redetermination of the recipient's eligibility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Posteligibility Requirements."> <paragraph num="A."> <text>Department's Responsibility. If it makes a determination as described in Regulation .08A of this chapter, the Department shall:</text> <paragraph num="(1)"> <text>Inform the applicant or recipient of the applicant's or recipient's legal rights and obligations; and</text> </paragraph> <paragraph num="(2)"> <text>Provide to the applicant or recipient written notice of the findings, rights, and obligations as specified in COMAR 10.09.24.12A(2) and (4) and Regulation .08B or C of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Recipient Responsibility.</text> <paragraph num="(1)"> <text>A recipient or the recipient's representative shall:</text> <paragraph num="(a)"> <text>Notify the Department within 10 business days of changes that may affect the recipient's eligibility for EID;</text> </paragraph> <paragraph num="(b)"> <text>Limit use of the Medical Assistance card to the individual whose name appears on the card;</text> </paragraph> <paragraph num="(c)"> <text>Cooperate with the Department by completing forms to report all pertinent information that would assist the Department in seeking reimbursement for expenditures made on the recipient's behalf;</text> </paragraph> <paragraph num="(d)"> <text>If services covered under the State Plan are provided for injuries resulting from an accident, provide to the Department:</text> <paragraph num="(i)"> <text>Notice as to the time, date, and location of the accident;</text> </paragraph> <paragraph num="(ii)"> <text>The name and address of the attorney;</text> </paragraph> <paragraph num="(iii)"> <text>The names and addresses of all parties and witnesses to the accident; and</text> </paragraph> <paragraph num="(iv)"> <text>The police report number if an investigation is made;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If written notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility; and</text> </paragraph> <paragraph num="(f)"> <text>Cooperate with the Medical Assistance Quality Control—Program Integrity.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A recipient's failure to comply with the provisions of §B(1) of this regulation may result in the adverse consequences specified in COMAR 10.09.24, including:</text> <paragraph num="(a)"> <text>Termination of benefits under this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Legal action.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Additional Recipient Responsibilities Concerning Third Party Reimbursement. A recipient of Medical Assistance in the EID coverage group:</text> <paragraph num="(1)"> <text>Is considered, as specified in COMAR 10.09.24, to have created an authorization for the release of data, records, and information necessary for the Department's pursuit of third-party reimbursement;</text> </paragraph> <paragraph num="(2)"> <text>Shall assign benefits to the Department and cooperate in the Department's recovery procedures as required in COMAR 10.09.24; and</text> </paragraph> <paragraph num="(3)"> <text>Shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments as specified in this regulation and Regulation .12 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Covered Services."> <paragraph num="A."> <text>Except as provided in §§B and C of this regulation, a recipient in the EID coverage group is covered for medically necessary services required by the recipient, if the services are:</text> <paragraph num="(1)"> <text>Furnished by a provider who, with respect to the services rendered, is approved by the Department to participate in the Medical Assistance Program;</text> </paragraph> <paragraph num="(2)"> <text>Covered under the State Plan;</text> </paragraph> <paragraph num="(3)"> <text>Not covered under ESI or any other health insurance coverage besides Medical Assistance; and</text> </paragraph> <paragraph num="(4)"> <text>Not the subject of any third party liability.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Copayments, Deductibles, and Coinsurance. Medical Assistance does not cover any copayments, deductibles, or coinsurance applicable to the ESI coverage of a recipient in the EID coverage group.</text> </paragraph> <paragraph num="C."> <text>An EID recipient is not entitled to:</text> <paragraph num="(1)"> <text>Enrollment in the Maryland Medicaid Managed Care Program (HealthChoice) in accordance with COMAR 10.09.62—10.09.75;</text> </paragraph> <paragraph num="(2)"> <text>Enrollment in Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69;</text> </paragraph> <paragraph num="(3)"> <text>Enrollment in the Program of All-Inclusive Care for the Elderly (PACE) under COMAR 10.09.44; or</text> </paragraph> <paragraph num="(4)"> <text>Long-term care facility services exceeding 30 consecutive days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Conditions of Participation and Reimbursement."> <text>The requirements for provider participation and reimbursement for services furnished to Medical Assistance recipients in the EID coverage group are governed by the same authorities that apply to services furnished to Medical Assistance recipients in other coverage groups, including:</text> <paragraph num="A."> <text>General Medical Assistance Provider Participation Criteria, as specified in COMAR 10.09.36; and</text> </paragraph> <paragraph num="B."> <text>Service-specific provisions included within regulations applicable to individual service categories.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Fraud, Liens, Recovery, and Reimbursement."> <paragraph num="A."> <text>The provisions of COMAR 10.09.24.14 concerning fraud apply to this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the circumstances specified in COMAR 10.09.24.15A-1.</text> </paragraph> <paragraph num="C."> <text>The Department may impose a lien on the property of a recipient under the circumstances specified in COMAR 10.09.24.15A-2(1).</text> </paragraph> <paragraph num="D."> <text>The Department shall seek recovery of Medical Assistance benefits correctly paid as provided in COMAR 10.09.24.15A-3.</text> </paragraph> <paragraph num="E."> <text>The Department shall accept reimbursement if voluntarily offered by a current or former recipient or by someone acting on behalf of the current or former recipient.</text> </paragraph> <paragraph num="F."> <text>Extended Benefits Pending a Hearing Decision.</text> <paragraph num="(1)"> <text>The Department shall refer for reimbursement consideration all cases in which:</text> <paragraph num="(a)"> <text>A recipient received extended benefits pending a hearing and decision by the hearing officer; and</text> </paragraph> <paragraph num="(b)"> <text>The hearing officer affirmed the decision of the Department that was the subject of the appeal.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department:</text> <paragraph num="(a)"> <text>Shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §F(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>May not apply §F(2)(a) of this regulation to an individual who requested a hearing and extended benefits based on a bona fide belief that the adverse action was erroneous.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall refer for investigation and other appropriate action all cases in which a recipient has received coverage erroneously as a result of the action or inaction of the recipient, representative, or individual acting responsibly for the recipient.</text> </paragraph> <paragraph num="H."> <text>The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or individual acting responsibly for the recipient.</text> </paragraph> <paragraph num="I."> <text>Providers.</text> <paragraph num="(1)"> <text>If a recipient has ESI or other coverage, or if any other individual is obligated, either legally or contractually, to pay for, or to reimburse the recipient for, services covered by this chapter, a provider of covered services shall seek payment from that source before submitting a claim to the Medical Assistance Program.</text> </paragraph> <paragraph num="(2)"> <text>If an insurance carrier rejects the provider's claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Medical Assistance Program, which shall be accompanied by a copy of the insurance carrier's notice or remittance advice.</text> </paragraph> <paragraph num="(3)"> <text>If payment is made by both the Medical Assistance Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Medical Assistance Program or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="(4)"> <text>A provider shall reimburse the Department for any overpayment.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Recipients. A recipient shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments by:</text> <paragraph num="(1)"> <text>Completing a form designated by the Department to report all pertinent information to assist the Department in seeking reimbursement for services provided;</text> </paragraph> <paragraph num="(2)"> <text>Notifying the Department within 10 days if medical treatment has been provided as a result of any accident or other occurrence in which a third party may be liable for health care services provided to the recipient; and</text> </paragraph> <paragraph num="(3)"> <text>Providing to the Department, as set forth in §J(2) of this regulation, the information required under such circumstances pursuant to COMAR 10.09.24.12 and Regulation .09B(1)(d) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Hearings."> <paragraph num="A."> <text>An EID applicant or recipient shall have the hearing rights specified in COMAR 10.01.04, subject to the qualification set forth in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>To apply the terms of COMAR 10.01.04 to the hearing rights of an EID applicant or recipient, substitute “the Department” for references therein to the “local department of social services”.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-138, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 adopted as an emergency provision effective April 1, 2006 (33:9 Md. R. 795); adopted permanently effective July 3, 2006 (33:13 Md. R. 1063)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective May 27, 2013 (40:10 Md. R. 917); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective May 27, 2013 (40:10 Md. R. 917)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12J amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12J amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> </annotations> </chapter> <chapter num="42" heading="Free-Standing Medicare-Certified Ambulatory Surgical Centers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Covered surgical procedures” means those surgical and other medical procedures which meet the criteria specified in 42 CFR Part 416, Subpart F, §416.166(a) and (b), and which are published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register.</text> </paragraph> <paragraph num="(2)"> <text>“Dental Benefits Administrator (DBA)” means an entity that administers the dental program for the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(5)"> <text>“Free-standing Ambulatory Surgery Center (ASC)” means an entity capable of providing ambulatory surgical services, which is not located in a hospital setting, and which is Medicare-certified to furnish ambulatory surgical services.</text> </paragraph> <paragraph num="(6)"> <text>“Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01.</text> </paragraph> <paragraph num="(7)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(8)"> <text>“Medicare” means Medicare as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(9)"> <text>“Medicare-certified facility” means a facility which:</text> <paragraph num="(a)"> <text>Is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS) to furnish ambulatory surgical services directly to patients;</text> </paragraph> <paragraph num="(b)"> <text>Has an agreement with (CMS) under Medicare to participate as an ASC; and</text> </paragraph> <paragraph num="(c)"> <text>Meets the conditions set forth by (CMS) in 42 CFR Part 416, Subparts B, C, and F, §416.163.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Patient” means a recipient awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(11)"> <text>“Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(12)"> <text>“Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered.</text> </paragraph> <paragraph num="(13)"> <text>“Program” means Program as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(14)"> <text>“Provider” means a free-standing ambulatory surgical center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number.</text> </paragraph> <paragraph num="(15)"> <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>License requirements under this chapter are referenced in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or 10.10.06, as applicable; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03 and 42 CFR, Part 416, Subpart B.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program are that the provider shall meet all specific conditions for participation as set forth in 42 CFR, Part 416, Subpart C, to include the following:</text> <paragraph num="(1)"> <text>Be approved by Medicare to furnish ambulatory surgical services to patients and maintain documentation of certification by the Department of Health and Human Services and the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(2)"> <text>Have clearly defined, written, patient care policies;</text> </paragraph> <paragraph num="(3)"> <text>Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>Recipient's reason for visit;</text> </paragraph> <paragraph num="(c)"> <text>A brief description of service provided, and</text> </paragraph> <paragraph num="(d)"> <text>A legible signature and printed or typed name of the professional providing care, with the appropriate title;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01;</text> </paragraph> <paragraph num="(5)"> <text>Be approved by the state in which the service is provided, except where a Certificate of Need is not required;</text> </paragraph> <paragraph num="(6)"> <text>Provide for in-house Program evaluation and clinical record review which assess use of services for appropriateness in meeting a recipient's needs;</text> </paragraph> <paragraph num="(7)"> <text>Refer laboratory testing only to independent medical laboratory providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following:</text> <paragraph num="A."> <text>Medically necessary facility services rendered to recipients in a free-standing Medicare-certified ambulatory surgical center;</text> </paragraph> <paragraph num="B."> <text>Diagnostic, curative, palliative, or rehabilitative services, when clearly related to the recipient's individual needs;</text> </paragraph> <paragraph num="C."> <text>Surgical procedures which meet the standards described in 42 CFR Part 416, Subpart D, §416.65, and as published by the Centers for Medicare and Medicaid Services; and</text> </paragraph> <paragraph num="D."> <text>Dental services that have been pre-authorized by the Dental Benefits Administrator (DBA).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>Services denied by Medicare as not medically justified;</text> </paragraph> <paragraph num="E."> <text>Separate billing of services which are included in the composite Medicare rate for an ambulatory surgical center;</text> </paragraph> <paragraph num="F."> <text>Surgical procedures which:</text> <paragraph num="(1)"> <text>Generally result in extensive blood loss;</text> </paragraph> <paragraph num="(2)"> <text>Require major or prolonged invasion of body cavities;</text> </paragraph> <paragraph num="(3)"> <text>Directly involve major blood vessels;</text> </paragraph> <paragraph num="(4)"> <text>Are generally emergency or life-threatening in nature;</text> </paragraph> <paragraph num="(5)"> <text>Commonly require systemic thrombolytic therapy;</text> </paragraph> <paragraph num="(6)"> <text>Are designated as requiring inpatient care (overnight);</text> </paragraph> <paragraph num="(7)"> <text>Can only be reported using a CPT unlisted surgical procedure code; or</text> </paragraph> <paragraph num="(8)"> <text>Are otherwise excluded under 42 CFR §411.15(a)—(h) and (j)—(s);</text> </paragraph> </paragraph> <paragraph num="G."> <text>Physicians' services, including surgical procedures and all preoperative and postoperative services performed by a physician;</text> </paragraph> <paragraph num="H."> <text>Anesthesia services;</text> </paragraph> <paragraph num="I."> <text>Radiology services other than those integral to performance of a covered surgical procedure;</text> </paragraph> <paragraph num="J."> <text>Diagnostic procedures other than those directly related to a covered surgical procedure;</text> </paragraph> <paragraph num="K."> <text>Ambulance services;</text> </paragraph> <paragraph num="L."> <text>Leg, arm, back, and neck braces other than those that serve the function of a cast or splint;</text> </paragraph> <paragraph num="M."> <text>Artificial limbs; or</text> </paragraph> <paragraph num="N."> <text>Non-implantable prosthetic devices and durable medical equipment (DME).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The Program reimburses a facility fee when the free-standing Medicare certified ambulatory surgery center provides a covered surgical procedure, in accordance with 42 CFR §416.166 to an eligible Medicaid recipient. Reimbursement for the facility fee includes, but is not limited to the following:</text> <paragraph num="(1)"> <text>Nursing, technician, and related services;</text> </paragraph> <paragraph num="(2)"> <text>Use of the facility;</text> </paragraph> <paragraph num="(3)"> <text>Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the provision of surgical procedures;</text> </paragraph> <paragraph num="(4)"> <text>Administrative costs;</text> </paragraph> <paragraph num="(5)"> <text>Materials including supplies and equipment for the administration and monitoring of anesthesia;</text> </paragraph> <paragraph num="(6)"> <text>Radiology services for which separate payment is not allowed and other diagnostic tests or interpretive services that are integral to a surgical procedure;</text> </paragraph> <paragraph num="(7)"> <text>Supervision of the services of a nurse anesthetist by the operating surgeon;</text> </paragraph> <paragraph num="(8)"> <text>Ancillary items and services that are integral to a covered surgical procedure as defined in 42 CFR §416.166; and</text> </paragraph> <paragraph num="(9)"> <text>Any laboratory testing performed under a Clinical Laboratory Improvement Amendment of 1988 (CLIA) certificate of waiver.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursement Methodology:</text> <paragraph num="(1)"> <text>Reimbursement fees equal 80 percent of the current Medicare-approved ASC facility fee for services furnished to Medicaid recipients in connection with covered surgical procedures.</text> </paragraph> <paragraph num="(2)"> <text>If one covered surgical procedure is furnished to a recipient, payment is at the Maryland Medicaid Program payment amount which is 80 percent of the current Medicare approved facility fee for that procedure.</text> </paragraph> <paragraph num="(3)"> <text>If more than one covered surgical procedure is provided to a recipient in a single operative session, payment is made at 100 percent of the Maryland Medicaid Program payment amount for the procedure with the highest reimbursement rate. Other covered surgical procedures furnished during the same session are reimbursed at 50 percent of the Maryland Medicaid Program payment amount for each procedure.</text> </paragraph> <paragraph num="(4)"> <text>When a covered surgical procedure is terminated before the completion due to extenuating circumstances or circumstances that threaten the well-being of the patient, the Medicaid Program payment amount is based on one of the following:</text> <paragraph num="(a)"> <text>If the covered procedure for which the anesthesia is planned is discontinued after the induction of anesthesia or after the procedure is started, the reimbursement amount is 80 percent of the current Medicare approved facility fee; or</text> </paragraph> <paragraph num="(b)"> <text>If the patient is prepared for surgery and the surgery is then cancelled before the induction of anesthesia, reimbursement shall be 50 percent of Maryland Medicaid payment amount.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Dental services rendered in an ASC on or after December 1, 2014, shall be reimbursed as follows:</text> <paragraph num="(1)"> <text>For covered dental services that have a reimbursement amount of $1,000 through $2,999.99, the ASC facility fee will be $600;</text> </paragraph> <paragraph num="(2)"> <text>For covered dental services that have a reimbursement amount of $3,000 through $4,999.99, the ASC facility fee will be $1,250;</text> </paragraph> <paragraph num="(3)"> <text>For covered dental services that have a reimbursement amount of $5,000 through $7,999.99, the ASC facility fee will be $2,500; and</text> </paragraph> <paragraph num="(4)"> <text>For covered dental services that have a reimbursement amount of $8,000 and over, the ASC facility fee will be $3,000.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A.</text> </paragraph> <paragraph num="E."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly completed, including but not limited to, diagnostic and procedure codes and description of services provided.</text> </paragraph> <paragraph num="F."> <text>The Program shall authorize payment on Medicare cross-over claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider; and</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically justified, excludes dental services.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible is paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of Regulation .04C of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Program shall make no direct payment to a recipient.</text> </paragraph> <paragraph num="J."> <text>The Program shall make no separate direct payment to any person employed by or under contract to any free-standing Medicare-certified ambulatory surgical center facility for services covered under this regulation.</text> </paragraph> <paragraph num="K."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures under this chapter are set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Interpretive regulations under this chapter are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 2, 1991 (18:17 Md. R. 1918)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective April 12, 2004 (31:7 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> </annotations> </chapter> <chapter num="43" heading="Maryland Children's Health Program (MCHP) Premium"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter governs the determination of eligibility and the conditions of participation for MCHP Premium with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56).</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means a child or the child's representative who has filed a written, telephonic, or electronic application for health coverage in an Insurance Affordability Program to the Department or its designee but has not received final action.</text> </paragraph> <paragraph num="(3)"> <text>“Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>“Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized representative” has the meaning stated in COMAR 10.01.04.12.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Designee" means any entity designated to act on behalf of the Department such as:</text> <paragraph num="(a)"> <text>Baltimore City or a county social services department under the supervision of the Department of Human Services;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore City Health Department and its subgrantees, or a county health department; and</text> </paragraph> <paragraph num="(c)"> <text>The Maryland Health Benefit Exchange</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Determination” means a decision regarding an applicant's eligibility for MCHP Premium.</text> </paragraph> <paragraph num="(9)"> <text>“Eligible individual” means a child who meets all nonfinancial eligibility requirements to participate in MCHP under COMAR 10.09.11 and whose family income is above 200 percent but at or below 300 percent of the federal poverty level.</text> </paragraph> <paragraph num="(10)"> <text>“Family contribution” means the portion of the premium cost paid for an eligible individual to enroll and participate in MCHP Premium.</text> </paragraph> <paragraph num="(11)"> <text>“Family member” means an individual living with the applicant whose income is counted, or would be counted as family income under Regulation .07 of this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Federal poverty level (FPL)” means the non-farm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981.</text> </paragraph> <paragraph num="(13)"> <text>“Group health plan” has the meaning stated in 42 U.S.C. §300gg-91.</text> </paragraph> <paragraph num="(14)"> <text>“Hardship” means unreasonable financial adversity or misfortune.</text> </paragraph> <paragraph num="(15)"> <text>“Health insurance coverage” has the meaning stated in 42 U.S.C. §300gg-91.</text> </paragraph> <paragraph num="(16)"> <text>“Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided.</text> </paragraph> <paragraph num="(17)"> <text>“Institution for mental disease (IMD)” has the meaning stated in COMAR 10.09.62.01B(78)(a).</text> </paragraph> <paragraph num="(18)"> <text>“Insurance Affordability Program” means a program that is one of the following:</text> <paragraph num="(a)"> <text>The Maryland State Medicaid program;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium;</text> </paragraph> <paragraph num="(c)"> <text>An optional State basic health program established under §1331 of the Affordable Care Act;</text> </paragraph> <paragraph num="(d)"> <text>A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or</text> </paragraph> <paragraph num="(e)"> <text>A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act.</text> </paragraph> <paragraph num="(20)"> <text>“MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI.</text> </paragraph> <paragraph num="(21)"> <text>“Managed care organization (MCO)” means:</text> <paragraph num="(a)"> <text>A certified health maintenance organization that is authorized to receive Medical Assistance prepaid capitation payments; or</text> </paragraph> <paragraph num="(b)"> <text>A corporation that:</text> <paragraph num="(i)"> <text>Is a managed care system that is authorized to receive Medical Assistance prepaid capitation payments;</text> </paragraph> <paragraph num="(ii)"> <text>Enrolls only program recipients, individuals, or families served under the Maryland Medicaid Managed Care Program; and</text> </paragraph> <paragraph num="(iii)"> <text>Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Maryland Children's Health Program (MCHP)” means the program established in Health-General Article, §15-301(b)(1), Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children.</text> </paragraph> <paragraph num="(23)"> <text>“Maryland Health Benefits Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program.</text> </paragraph> <paragraph num="(24)"> <text>“Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.62.01B(88).</text> </paragraph> <paragraph num="(25)"> <text>“MCHP Premium” means the program established in Health-General Article, §15-301.1 et seq., Annotated Code of Maryland, to provide access to health coverage to eligible individuals through managed care organizations (MCOs) under MCHP.</text> </paragraph> <paragraph num="(26)"> <text>“Medical institution” means an institution that:</text> <paragraph num="(a)"> <text>Is organized to provide medical care, including nursing and convalescent care;</text> </paragraph> <paragraph num="(b)"> <text>Has the necessary professional equipment and facilities to manage the medical, nursing, and other health needs of a patient on a continuing basis in accordance with accepted standards;</text> </paragraph> <paragraph num="(c)"> <text>Is authorized under State law to provide medical care; and</text> </paragraph> <paragraph num="(d)"> <text>Is staffed by medical and nursing professionals.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Period under consideration” means the specific months that are assessed in order to determine eligibility for MCHP Premium.</text> </paragraph> <paragraph num="(28)"> <text>Public Institution.</text> <paragraph num="(a)"> <text>“Public institution” means an:</text> <paragraph num="(i)"> <text>Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or</text> </paragraph> <paragraph num="(ii)"> <text>Establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Public institution” does not include a medical institution, a skilled nursing facility, or a publicly operated community residence that serves fewer than 17 residents.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Qualified alien” means an individual who:</text> <paragraph num="(a)"> <text>Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA);</text> </paragraph> <paragraph num="(b)"> <text>Has been granted asylum in the United States as a refugee under §208 of the INA;</text> </paragraph> <paragraph num="(c)"> <text>Has been admitted into the United States as a refugee under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year;</text> </paragraph> <paragraph num="(e)"> <text>Has had deportation withheld under §243(h) of the INA;</text> </paragraph> <paragraph num="(f)"> <text>Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980;</text> </paragraph> <paragraph num="(g)"> <text>Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if:</text> <paragraph num="(i)"> <text>The spouse or parent consented to, or acquiesced in, the battery or cruelty;</text> </paragraph> <paragraph num="(ii)"> <text>The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with INS; and</text> </paragraph> <paragraph num="(iii)"> <text>In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Is a victim of a severe form of trafficking who has been subjected to:</text> <paragraph num="(i)"> <text>Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or</text> </paragraph> <paragraph num="(ii)"> <text>Involuntary servitude;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or</text> </paragraph> <paragraph num="(j)"> <text>Is an American Indian born in Canada to whom §289 of the Immigration and Nationality Act applies.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Recipient” means a child younger than 19 years old who is certified as eligible for MCHP Premium.</text> </paragraph> <paragraph num="(31)"> <text>“Redetermination” means a determination regarding the continuing eligibility of a recipient.</text> </paragraph> <paragraph num="(32)"> <text>“Representative” means:</text> <paragraph num="(a)"> <text>A parent or parents living with the applicant;</text> </paragraph> <paragraph num="(b)"> <text>The applicant's guardian; or</text> </paragraph> <paragraph num="(c)"> <text>The applicant's authorized representative.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Title XXI” means the title of the Social Security Act through which funding is provided, in part, for MCHP Premium.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Coverage Groups."> <text>Eligibility may be established for the MCHP Premium Program for children younger than 19 years old whose household income is above 200 percent but at or below 300 percent of the Federal Poverty Level.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Application."> <paragraph num="A."> <text>The Department or its designee shall determine eligibility for children.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall give oral, written, or electronic information about MCHP Premium such as:</text> <paragraph num="(1)"> <text>Requirements for eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Available services;</text> </paragraph> <paragraph num="(3)"> <text>An individual's rights and responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>Information in plain English, supported by translation services; and</text> </paragraph> <paragraph num="(5)"> <text>Information accessible to disabled individuals requesting an application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply.</text> </paragraph> <paragraph num="D."> <text>The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application.</text> </paragraph> <paragraph num="E."> <text>Applicant Temporarily Absent from the State.</text> <paragraph num="(1)"> <text>If an applicant is temporarily absent from the State, the applicant or the applicant's representative may apply for assistance by telephone, mail, in person, internet, and other electronic means to the Department or its designee in any jurisdiction.</text> </paragraph> <paragraph num="(2)"> <text>To establish eligibility for MCHP Premium for an applicant temporarily absent from the State, the applicant or the applicant's representative shall:</text> <paragraph num="(a)"> <text>Affirm that:</text> <paragraph num="(i)"> <text>The applicant intends to return to the State; or</text> </paragraph> <paragraph num="(ii)"> <text>The applicant's parent or guardian intends to return the applicant to the State;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Demonstrate the applicant's continued residency in the State; and</text> </paragraph> <paragraph num="(c)"> <text>Meet other technical and financial requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Application Filing and Signature Requirements.</text> <paragraph num="(1)"> <text>An individual who wishes to apply for health coverage under Insurance Affordability Program shall submit a written, telephonic, or electronic application, signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice.</text> </paragraph> <paragraph num="(2)"> <text>A signed application is required for all applicants who request assistance. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those persons.</text> </paragraph> <paragraph num="(3)"> <text>The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>The following individuals shall complete and sign a written or electronic application:</text> <paragraph num="(a)"> <text>An applicant;</text> </paragraph> <paragraph num="(b)"> <text>An applicant’s parents living with the child applicant; or</text> </paragraph> <paragraph num="(c)"> <text>If the applicant does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application form.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §H of this regulation.</text> </paragraph> <paragraph num="H."> <text>Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §F(3) of this regulation, for a 12-month period beginning with the month of application.</text> </paragraph> <paragraph num="I."> <text>Processing Applications — Time Limitations.</text> <paragraph num="(1)"> <text>When a written, telephonic or electronic application is filed, a decision shall be made promptly, but not later than 60 calendar days from the application date.</text> </paragraph> <paragraph num="(2)"> <text>The time period specified in §I(1) of this regulation covers the period from the application date to the date the Department or its designee sends a written or electronic notice of its decision to the applicant or the applicant's representative.</text> </paragraph> <paragraph num="(3)"> <text>The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit.</text> </paragraph> <paragraph num="(4)"> <text>When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 60 calendar day limit provided under §I(1) of this regulation, the applicant shall be determined ineligible.</text> </paragraph> <paragraph num="(5)"> <text>The Department or its designee shall provide notice of delay for extenuating circumstances within 60 calendar days of the delay, stating the reason for the delay and the anticipated date of decision.</text> </paragraph> <paragraph num="(6)"> <text>If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Information Required.</text> <paragraph num="(1)"> <text>All information needed to determine eligibility for the MCHP Premium shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall provide the additional information within a reasonable time limit as established by the Department.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide required information within the 60 calendar days, the applicant shall be determined ineligible.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Social Security Number.</text> <paragraph num="(1)"> <text>As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection.</text> </paragraph> <paragraph num="(2)"> <text>Eligibility may not be established until the applicant:</text> <paragraph num="(a)"> <text>Furnishes a Social Security number; or</text> </paragraph> <paragraph num="(b)"> <text>Requests the assignment of the number through the Social Security Administration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failure to provide the required Social Security number shall result in ineligibility for the applicant.</text> </paragraph> <paragraph num="(4)"> <text>If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds.</text> </paragraph> <paragraph num="(5)"> <text>If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Third-Party Liability.</text> <paragraph num="(1)"> <text>An applicant shall notify the Department or its designee within 10 working days if medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party may be liable for the recipient's medical expenses.</text> </paragraph> <paragraph num="(2)"> <text>An applicant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments.</text> </paragraph> <paragraph num="(3)"> <text>In accident situations, a representative shall notify the Department or its designee of the:</text> <paragraph num="(a)"> <text>Time, date, and location of the accident;</text> </paragraph> <paragraph num="(b)"> <text>Name and address of the attorney;</text> </paragraph> <paragraph num="(c)"> <text>Names and addresses of all parties and witnesses to the accident; and</text> </paragraph> <paragraph num="(d)"> <text>Police report number if an investigation is made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Consent Forms. An applicant shall give consent to verify information to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Nonfinancial Eligibility Requirements."> <paragraph num="A."> <text>Citizenship. In order to be eligible for full benefits under MCHP Premium, an applicant shall be one of the following:</text> <paragraph num="(1)"> <text>A citizen of the United States;</text> </paragraph> <paragraph num="(2)"> <text>A person residing in the United States who is:</text> <paragraph num="(a)"> <text>A qualified alien as defined under Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>An honorably discharged veteran of the armed forces of the United States;</text> </paragraph> <paragraph num="(c)"> <text>An alien on active duty in the armed forces of the United States; or</text> </paragraph> <paragraph num="(d)"> <text>The spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran of or alien on active duty in the armed forces of the United States;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual residing in the United States who is:</text> <paragraph num="(a)"> <text>An alien who has been granted asylum under §208 of the Immigration and Nationality Act;</text> </paragraph> <paragraph num="(b)"> <text>A refugee admitted into the United States under §207 of the Immigration and Nationality Act;</text> </paragraph> <paragraph num="(c)"> <text>An alien whose deportation has been withheld under §243(h) of the Immigration and Nationality Act;</text> </paragraph> <paragraph num="(d)"> <text>A Cuban or Haitian entrant;</text> </paragraph> <paragraph num="(e)"> <text>An alien admitted to the country for permanent residence as an Amerasian immigrant under Title II of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1989;</text> </paragraph> <paragraph num="(f)"> <text>A legal permanent resident who first entered the country under another exempt category, that is, as a refugee, asylee, Cuban or Haitian entrant, trafficking victim, or alien whose deportation was being withheld, and who later converted to legal permanent resident status;</text> </paragraph> <paragraph num="(g)"> <text>A victim of a severe form of trafficking who has been subjected to:</text> <paragraph num="(i)"> <text>Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or</text> </paragraph> <paragraph num="(ii)"> <text>Involuntary servitude;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>An honorably discharged veteran of the armed forces of the United States;</text> </paragraph> <paragraph num="(i)"> <text>An alien on active duty in the armed forces of the United States; or</text> </paragraph> <paragraph num="(j)"> <text>A spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran or alien on active duty in the armed forces of the United States; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual residing in the United States who is a qualified alien as defined under Regulation .02B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Residency. The requirements relating to residency under COMAR 10.09.24.05-3 apply to this chapter.</text> </paragraph> <paragraph num="C."> <text>Age. In order to be eligible for benefits, under this chapter a child shall be younger than 19 years old.</text> </paragraph> <paragraph num="D."> <text>Inmate of a Public Institution. In order to receive benefits under this chapter, an applicant may not be an inmate of a public institution.</text> </paragraph> <paragraph num="E."> <text>Institution for Mental Diseases or Mental Hospital. An applicant who is a patient in an institution for mental diseases or mental hospital is not eligible for benefits under this chapter.</text> </paragraph> <paragraph num="F."> <text>Access to or Coverage under Other Health Benefit Plans.</text> <paragraph num="(1)"> <text>Current Coverage. Except for coverage purchased in the context of participating in MCHP Premium, an applicant or recipient is not eligible for MCHP Premium if the applicant or recipient is covered:</text> <paragraph num="(a)"> <text>As a dependent under an employer-sponsored group health plan; or</text> </paragraph> <paragraph num="(b)"> <text>Under health insurance coverage.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Past Coverage. In order to be eligible for benefits under this chapter, an applicant may not be covered by employer-sponsored insurance or have been voluntarily terminated from an employer-sponsored insurance within 6 months before the date of the application, except for coverage purchased in the context of participating in MCHP Premium. Voluntary termination does not include:</text> <paragraph num="(a)"> <text>Loss of employment due to factors other than voluntary termination;</text> </paragraph> <paragraph num="(b)"> <text>Change to a new employer that does not provide an option for dependent coverage;</text> </paragraph> <paragraph num="(c)"> <text>Change of address so that no employer-sponsored health benefit plan is available;</text> </paragraph> <paragraph num="(d)"> <text>Discontinuation of health benefits to all dependents of employees of the parent's or guardian's employer; or</text> </paragraph> <paragraph num="(e)"> <text>Expiration of the applicant's continuation of coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA).</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Duration of Eligibility. After an individual has been determined to be eligible for MCHP Premium and is enrolled in MCHP Premium:</text> <paragraph num="(1)"> <text>The Department shall periodically redetermine the recipient's eligibility for MCHP Premium as specified in Regulation .15D of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's:</text> <paragraph num="(a)"> <text>Income;</text> </paragraph> <paragraph num="(b)"> <text>Employment;</text> </paragraph> <paragraph num="(c)"> <text>Address; or</text> </paragraph> <paragraph num="(d)"> <text>Health insurance coverage status.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Consideration of Family Income."> <paragraph num="A."> <text>The applicant shall report the income of each family member, except for the income of members that do not file a federal tax return and are not claimed as a federal tax dependent.</text> </paragraph> <paragraph num="B."> <text>Determining Countable Household Income.</text> <paragraph num="(1)"> <text>In determining an applicant's financial eligibility for MCHP Premium, the applicant's current household income shall be considered.</text> </paragraph> <paragraph num="(2)"> <text>For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the applicant and the applicant's parent or parents, if living with the applicant.</text> </paragraph> <paragraph num="(3)"> <text>For the married child applicant, household income shall consist of the income of the married child applicant and the married child applicant's spouse.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application.</text> </paragraph> <paragraph num="D."> <text>Treatment of Income.</text> <paragraph num="(1)"> <text>Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI.</text> </paragraph> <paragraph num="(2)"> <text>MAGI income limits shall be:</text> <paragraph num="(a)"> <text>Converted from traditional income limits to account for elimination of income disregards; and</text> </paragraph> <paragraph num="(b)"> <text>Increased by 5 percentage points of the federal poverty level for the following circumstances:</text> <paragraph num="(i)"> <text>When an individual’s income exceeds the Medicaid income standard; and</text> </paragraph> <paragraph num="(ii)"> <text>The income standard is the highest income standard under which the individual can be determined eligible.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Household Composition. For purposes of determining the income standard applicable to an applicant the following rules apply:</text> <paragraph num="(a)"> <text>An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made.</text> </paragraph> <paragraph num="(b)"> <text>For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals:</text> <paragraph num="(i)"> <text>Spouse; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted or step children.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals:</text> <paragraph num="(i)"> <text>Natural, adopted, or step parents; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted, or step siblings.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>No resources or assets test may be applied to applicants or recipients who are subject to a MAGI-based income test.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Consideration of Family Income: Earned and Unearned Income — Repealed." /> <regulation prefix="Regulation" num=".08" heading="Consideration of Family Income: Income Disregards — Repealed." /> <regulation prefix="Regulation" num=".09" heading="Determining Financial Eligibility."> <text>Current and New Enrollees. An applicant is financially eligible for MCHP Premium if, for the period under consideration, the applicant's countable household income as determined under Regulation .06 of this chapter, is greater than 200 percent but not greater than 300 percent of the federal poverty level for the number of persons in an applicant’s tax-dependent unit equal to the size of the applicant's family.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Certification Periods."> <paragraph num="A."> <text>The certification period begins the first day of the month in which the eligible child is enrolled in a MCO.</text> </paragraph> <paragraph num="B."> <text>Duration of Certification Period.</text> <paragraph num="(1)"> <text>The initial certification period, or the certification period beginning after a period of ineligibility for MCHP Premium, shall end not later than 1 year from the beginning month of certification for MCHP Premium.</text> </paragraph> <paragraph num="(2)"> <text>Notwithstanding §B(1) of this regulation, the certification period may be shortened:</text> <paragraph num="(a)"> <text>If a determination of ineligibility is made; or</text> </paragraph> <paragraph num="(b)"> <text>At the request of the representative.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under MCHP Premium and who, but for attaining that age, is otherwise eligible for MCHP Premium, shall remain eligible for MCHP Premium until the end of the stay for which acute inpatient services are furnished.</text> </paragraph> <paragraph num="D."> <text>Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Services."> <text>A child enrolled in MCHP Premium is eligible for all health benefits included in the Maryland Medicaid Managed Care Program, as set forth in COMAR 10.09.67, the school-based health centers program as set forth in COMAR 10.09.68, and the rare and expensive case management.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Program Participation Requirements — Enrollment."> <paragraph num="A."> <text>An eligible individual who is enrolled in MCHP Premium shall be covered through a Maryland Medicaid Managed Care MCO.</text> </paragraph> <paragraph num="B."> <text>Timely Enrollment. The representative shall:</text> <paragraph num="(1)"> <text>Send to the Department or its designee the first month's family contribution within 30 days of receiving notice of eligibility for MCHP Premium, before enrollment can be completed; and</text> </paragraph> <paragraph num="(2)"> <text>Complete and submit to the Department's enrollment broker a MCO selection and enrollment form within 28 days of receiving notice of eligibility for each eligible child.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Program Participation Requirements — Family Contribution."> <paragraph num="A."> <text>Family Contribution Required. As a requirement of enrollment and participation in MCHP Premium, the representative of an eligible individual shall agree to pay the following annual family contribution:</text> <paragraph num="(1)"> <text>For an eligible individual whose family income is above 200 percent but at or below 250 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 200 percent of the FPL; and</text> </paragraph> <paragraph num="(2)"> <text>For an eligible individual whose family income is above 250 percent, but at or below 300 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 250 percent of the FPL.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The family contribution amounts required under §A of this regulation apply on a per family basis regardless of the number of eligible individuals each family has enrolled in MCHP Premium.</text> </paragraph> <paragraph num="C."> <text>American Indians and Alaskan Natives are exempt from a family contribution requirement.</text> </paragraph> <paragraph num="D."> <text>Payment Procedures.</text> <paragraph num="(1)"> <text>The representative shall send the initial month's payment to the Department or its designee by electronic transfer, money order, or check.</text> </paragraph> <paragraph num="(2)"> <text>For months following the initial month of coverage:</text> <paragraph num="(a)"> <text>The Department or its designee shall bill at the start of each month for the next month's family contribution and shall provide a self-addressed stamped envelope for return of the family contribution;</text> </paragraph> <paragraph num="(b)"> <text>The representative shall make the family contribution payment in full to continue coverage, unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>The Department or its designee shall notify the applicant of the amount due and instruct on the manner of payment and date due, if timely payment has not been made; and</text> </paragraph> <paragraph num="(d)"> <text>The applicant shall make payment in full of amounts due to the Department or its designee no later than 30 days after the date of issuance of a request for payment, to ensure continuing eligibility unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Hardship.</text> <paragraph num="(1)"> <text>The applicant shall submit the claim of hardship in writing within 10 days of receipt of the Department's request for payment.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall evaluate claims of hardship and notify the applicant of the decision within 30 days of receipt of the written claim of hardship.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Program Participation Requirements — Change in Status."> <paragraph num="A."> <text>The applicant shall report any change in family status or family composition within 10 days of the change.</text> </paragraph> <paragraph num="B."> <text>Change in family status includes increase or decrease in the number of family members through birth, death, marriage, adoption, separation, divorce, or the voluntary or involuntary removal of a family member from residence with the family.</text> </paragraph> <paragraph num="C."> <text>The applicant shall complete a written, telephonic, or electronic application and file it with the Department or its designee in any jurisdiction to apply for coverage for a child added to the family, including a newborn child, unless the newborn child's mother was eligible for Medicaid when the child was born.</text> </paragraph> <paragraph num="D."> <text>For all changes except addition of a child, the Department or its designee shall evaluate the effect of the change on continued eligibility for MCHP Premium and notify the applicant of its determination within 60 days of the report of the change.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Post-Eligibility Requirements."> <paragraph num="A."> <text>Notice of Eligibility Determination. The Department or its designee shall inform the applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following:</text> <paragraph num="(1)"> <text>For eligible individuals:</text> <paragraph num="(a)"> <text>The basis and effective date for eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Instructions for reporting changes that may affect the recipient’s eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For ineligible individuals:</text> <paragraph num="(a)"> <text>A finding of ineligibility, the reason for the finding, and the regulation supporting the finding;</text> </paragraph> <paragraph num="(b)"> <text>Information regarding application for MAGI excluded coverage groups; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Applicant Responsibility.</text> <paragraph num="(1)"> <text>The applicant shall notify the Department within 10 working days of changes affecting the applicant’s eligibility.</text> </paragraph> <paragraph num="(2)"> <text>Only an applicant that has been determined eligible by the Department or its designee shall use MCHP Premium benefits.</text> </paragraph> <paragraph num="(3)"> <text>If written or electronic notice of cancellation is received, the applicant shall discontinue use of MCHP Premium benefits on the first day of ineligibility.</text> </paragraph> <paragraph num="(4)"> <text>Failure to comply with the provisions of §B(1)—(3) of this regulation may result in:</text> <paragraph num="(a)"> <text>The termination of assistance; or</text> </paragraph> <paragraph num="(b)"> <text>Referral to the Department for fraud investigation, or for criminal or civil prosecution.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The applicant shall cooperate with the Department’s quality control review process, including verification of all information pertinent to the determination of eligibility.</text> </paragraph> <paragraph num="(6)"> <text>If the applicant refuses to cooperate, the applicant’s coverage shall be terminated.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unscheduled Redetermination.</text> <paragraph num="(1)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Promptly make an unscheduled redetermination of a recipient's eligibility if changes in circumstances or relevant facts are:</text> <paragraph num="(i)"> <text>Reported by someone on the applicant’s behalf; or</text> </paragraph> <paragraph num="(ii)"> <text>Brought to the attention of the Department from other responsible sources; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Eligibility Decisions. Recipients who are determined:</text> <paragraph num="(a)"> <text>Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A recipient whose eligibility has been canceled may reapply for MCHP at any time.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Scheduled Redetermination.</text> <paragraph num="(1)"> <text>Redetermination is required to establish continued eligibility.</text> </paragraph> <paragraph num="(2)"> <text>Redetermination shall be scheduled annually.</text> </paragraph> <paragraph num="(3)"> <text>Completion of the application and determination of eligibility for MCHP by the Department or its designee is required for renewal for program eligibility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Hearings."> <text>The requirements relating to hearings under COMAR 10.01.04 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Fraud, Abuse, and Penalty."> <paragraph num="A."> <text>The requirements relating to fraud and recipient abuse under COMAR 10.09.24.14 apply to this chapter.</text> </paragraph> <paragraph num="B."> <text>A person convicted of fraud under this chapter is subject to penalties as described in Criminal Law Article, §§8-516 and 8-517, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Adjustments and Recoveries."> <text>In all cases where MCHP Premium benefits have been incorrectly paid, the Department shall seek recovery pursuant to COMAR 10.09.24.15.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services for MCHP Premium recipients without regard to the availability of federal financial participation.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-101(f), 15-103(a)(2), 15-301.1, and 15-302—15-304;Insurance Article, §§15-1208, 15-1213, 15-1406, and 27-220;Annotated Code of Maryland; Ch. 202, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.19 adopted as an emergency provision effective July 1, 2001 (28:12 Md. R. 1102); adopted permanently effective September 3, 2001 (28:17 Md. R. 1556)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective November 10, 2003 (30:22 Md. R. 1580); April 19, 2010 (37:8 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F, G amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A and B amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1284); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 6, 2014 (40:26 Md. R. 2162)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D adopted effective April 13, 2026 (53:7 Md. R. 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended effective April 13, 2026 (53:7 Md. R. 328)</annotation> </annotations> </chapter> <chapter num="44" heading="Programs of All-Inclusive Care for the Elderly (PACE)"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Amount that would otherwise have been paid (AWOP)” means the amount the Program expects to have paid for services for a PACE participant under the State Plan had the participant not enrolled under the PACE program.</text> </paragraph> <paragraph num="(2)"> <text>“Community spouse” means an individual who:</text> <paragraph num="(a)"> <text>Lives in the community outside a long-term care facility;</text> </paragraph> <paragraph num="(b)"> <text>Is not determined to meet the criteria for participation for:</text> <paragraph num="(i)"> <text>PACE under this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>A waiver under §1915(c) of the Social Security Act; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is married to an institutionalized spouse.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Continuous period of institutionalization” means at least 30 consecutive days of institutional care in a long-term care facility.</text> </paragraph> <paragraph num="(4)"> <text>“Contract” means a written agreement between a PACE provider and a third party under which the third party agrees to perform one or more of the PACE provider's obligations under this chapter or the PACE agreement.</text> </paragraph> <paragraph num="(5)"> <text>“Capitation payment” means the sum of money paid in advance on a monthly per capita basis to a PACE provider by the Department on a participant's behalf for the PACE provider benefit package specified in the PACE Program Agreement.</text> </paragraph> <paragraph num="(6)"> <text>“Centers for Medicare and Medicaid Services (CMS)” means the federal administering agency for the Medicare and Medicaid program benefits in PACE.</text> </paragraph> <paragraph num="(7)"> <text>“Contractor” means an entity with which the PACE provider has a contract agreement.</text> </paragraph> <paragraph num="(8)"> <text>“Contract year” means the term of a PACE Program Agreement, which is a calendar year, except that a PACE provider's initial contract year may be from 12 to 23 months, as determined by CMS.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01B, or its authorized agents acting on its behalf.</text> </paragraph> <paragraph num="(10)"> <text>“Eligible person” means any person who meets the eligibility requirements for enrollment in the PACE program as specified in the PACE program agreement and Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing the individual's health in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions; or</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Emergency services” means health care services that are:</text> <paragraph num="(a)"> <text>Covered under the PACE provider benefit package;</text> </paragraph> <paragraph num="(b)"> <text>Provided to a PACE participant with an emergency medical condition;</text> </paragraph> <paragraph num="(c)"> <text>Rendered by entities who are not employees or agents of the PACE provider and with whom the PACE provider does not have a contract; and</text> </paragraph> <paragraph num="(d)"> <text>Provided in a hospital emergency facility or a free-standing urgent care center as defined in COMAR 10.09.77.01.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Insolvency” means that the entity's net tangible equity or fund balance is negative and results from total program expenditures exceeding total program revenues to date.</text> </paragraph> <paragraph num="(14)"> <text>“Institutionalized spouse” means an individual who is married to a community spouse and who is:</text> <paragraph num="(a)"> <text>An inpatient in a long-term care facility with a length of stay exceeding 30 days; or</text> </paragraph> <paragraph num="(b)"> <text>Determined to meet the criteria for participation for:</text> <paragraph num="(i)"> <text>PACE under this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>A waiver under §1915(c) of Title XIX of the Social Security Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Long-term care facility” means a nursing facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or psychiatric hospital.</text> </paragraph> <paragraph num="(16)"> <text>“Medicaid Provider Agreement” means the agreement between Medicaid providers, including PACE providers, and the Department that allows providers to provide services to Medicaid participants</text> </paragraph> <paragraph num="(17)"> <text>“Medical Assistance Program” means the Maryland Medical Assistance Program, as defined in COMAR 10.09.36.01B.</text> </paragraph> <paragraph num="(18)"> <text>“Medically necessary” means directly related to diagnostic, preventive, curative, palliative, or rehabilitative treatment.</text> </paragraph> <paragraph num="(19)"> <text>“Medicare” means the federal program that provides benefits to aged or disabled individuals under Title XVIII of the Social Security Act.</text> </paragraph> <paragraph num="(20)"> <text>“PACE enrollment limit” means the maximum number of Medicaid participants permitted to the PACE provider as declared in the State Certification Page of the CMS PACE provider application.</text> </paragraph> <paragraph num="(21)"> <text>“PACE benefit package” means a prepaid, comprehensive package of all the health care services to which a PACE provider's participants are entitled under the State Plan when the services are medically necessary and appropriate.</text> </paragraph> <paragraph num="(22)"> <text>“PACE center” means a facility operated by a PACE provider where primary care is furnished to participants.</text> </paragraph> <paragraph num="(23)"> <text>“PACE Organization Provider Agreement” is the agreement between the PACE Provider and the Department that contains provisions to provide additional protections to PACE participants.</text> </paragraph> <paragraph num="(24)"> <text>“PACE participant” means an eligible person who voluntarily enrolls and enters into an agreement with a PACE provider or an eligible person who is enrolled by a legal representative.</text> </paragraph> <paragraph num="(25)"> <text>“PACE provider” means an entity that is approved by the Department and CMS to provide the PACE benefit package covered under this chapter to Medical Assistance participants.</text> </paragraph> <paragraph num="(26)"> <text>“PACE Program Agreement” means a written, signed agreement between the Department, CMS, and the PACE provider, which specifies the terms of the relationship between the Department and the PACE provider and authorizes the PACE provider to operate in the State.</text> </paragraph> <paragraph num="(27)"> <text>“Participant” means an individual who is certified by the Department as eligible to receive Medical Assistance Program benefits.</text> </paragraph> <paragraph num="(28)"> <text>“Primary care” means health care services that address an individual's general health needs, including the coordination of the individual's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the individual's health records, and referral for medically necessary and appropriate specialty care.</text> </paragraph> <paragraph num="(29)"> <text>“Primary care provider” means a practitioner who provides a participant's primary care services and is the primary coordinator of all other health care services for the participant, responsible for providing or assuring access to continuous, comprehensive, and coordinated health care services covered in the PACE benefit package.</text> </paragraph> <paragraph num="(30)"> <text>“Professional standards” means professional requirements set forth in the Annotated Code of Maryland or by the national accrediting body for a practitioner's profession.</text> </paragraph> <paragraph num="(31)"> <text>“Program” means the Medical Assistance Program, as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(32)"> <text>“Programs of All-Inclusive Care for the Elderly (PACE)” means a jointly administered capitated Medicare/Medicaid program providing medical and long term care services to nursing home eligible, frail, elderly participants.</text> </paragraph> <paragraph num="(33)"> <text>“Quality Assurance and Performance Improvement Plan (QAPI)” means a document or series of documents that set forth a PACE provider's strategy for systematically monitoring, evaluating, and improving all facets of operations including, but not limited to, clinical health care delivery, participant assistance and outreach services, and administrative services.</text> </paragraph> <paragraph num="(34)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(35)"> <text>“Service area” means a defined geographic area selected by the PACE provider and approved by the Department in the PACE program agreement, in which the complete PACE benefit package is available to all the PACE provider's participants, and beyond which the PACE provider is restricted from directly marketing its services.</text> </paragraph> <paragraph num="(36)"> <text>“Services” includes both items and services.</text> </paragraph> <paragraph num="(37)"> <text>“State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services pursuant to Title XIX of the Social Security Act, as modified or amended.</text> </paragraph> <paragraph num="(38)"> <text>“Trial period” means the first 3 contract years in which a PACE organization operates under a PACE program agreement, including any contract year during which the entity operated under a PACE demonstration waiver program.</text> </paragraph> <paragraph num="(39)"> <text>“Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for Qualification as a PACE Provider."> <text>An applicant for participation in the Program as a PACE provider shall submit to the Department and CMS a complete PACE application that describes how the entity meets all requirements in 42 CFR 460 et seq.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="PACE Provider."> <paragraph num="A."> <text>The PACE provider shall comply with:</text> <paragraph num="(1)"> <text>42 CFR 460 et seq.;</text> </paragraph> <paragraph num="(2)"> <text>This chapter;</text> </paragraph> <paragraph num="(3)"> <text>The Medicaid provider agreement and the PACE Organization Provider Agreement signed with the Department;</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.09.36;</text> </paragraph> <paragraph num="(5)"> <text>Standards in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.;</text> </paragraph> <paragraph num="(6)"> <text>Any other applicable regulations, transmittals, and guidelines issued by the Department that are in effect; and</text> </paragraph> <paragraph num="(7)"> <text>All other requirements of applicable federal and State law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The PACE provider shall have a signed PACE program agreement with the Department and CMS which establishes the terms of the relationship between the PACE provider and the Department.</text> </paragraph> <paragraph num="C."> <text>The PACE provider shall obtain approval by the Department before establishing additional care sites.</text> </paragraph> <paragraph num="D."> <text>The PACE provider shall obtain approval by the Department before expanding its service area.</text> </paragraph> <paragraph num="E."> <text>Professional and Administrative Standards. The PACE provider shall have the professional and administrative ability and staffing to carry out its duties and responsibilities according to the PACE Program Agreement and PACE Organization Provider Agreement, which shall include the following:</text> <paragraph num="(1)"> <text>A full-time administrator;</text> </paragraph> <paragraph num="(2)"> <text>Sufficient allied health, medical social work, clerical, and support staff to provide proper medical care within acceptable professional standards;</text> </paragraph> <paragraph num="(3)"> <text>A demonstrated ability to deliver health services within the service area according to standards established by the Department;</text> </paragraph> <paragraph num="(4)"> <text>A management information system, which shall:</text> <paragraph num="(a)"> <text>Meet the requirements of Regulations .14 and .15 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain medical and financial records for 10 years;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An acceptable PACE participant grievance and appeals procedure and system for reporting the disposition of grievances and appeals to the Department, as specified in Regulation .19 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>A procedure established to provide PACE participants an ability to participate in matters of policy and operation; and</text> </paragraph> <paragraph num="(7)"> <text>A sufficient quality assurance and performance improvement system, as specified in Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Nondiscrimination. In connection with the performance of its obligations under this chapter, the PACE provider shall comply with all applicable federal and State laws, regulations, or orders which prohibit discrimination on grounds of race, age, creed, sex, color, national origin, marital status, physical or mental handicap, health status, or need for health services.</text> </paragraph> <paragraph num="G."> <text>Provision of Services and Health Care Delivery. A PACE provider shall provide:</text> <paragraph num="(1)"> <text>The services set forth in Regulation .09 of this chapter and covered under the PACE provider benefit package:</text> <paragraph num="(a)"> <text>Promptly and continuously, consistent with accepted medical practice and community professional standards; and</text> </paragraph> <paragraph num="(b)"> <text>Through its own employees and agents or through contractors, except for emergency services; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Written notice to PACE participants if there is a significant change in the nature, location, or provider of services provided.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The PACE provider may not knowingly have as a director, officer, partner, or owner of more than 5 percent of the entity's equity, a person or an affiliate of a person who is or has been debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued pursuant to federal Executive Order No. 12549 or under guidelines implementing such an order.</text> </paragraph> <paragraph num="I."> <text>The PACE provider may not knowingly have an employment, consulting, or other agreement with a person described in §H of this regulation, for the provision of items and services that are significant and material to the PACE provider's obligations under this chapter.</text> </paragraph> <paragraph num="J."> <text>The PACE provider and its agents and employees, in the performance of the services covered under this chapter, shall act in an independent capacity and may not act as officers, employees, or agents of the Department.</text> </paragraph> <paragraph num="K."> <text>An individual employed by the State or any department, commission, agency, or branch of the State, whose duties include matters relating to or affecting the subject matter of this chapter, may not be an employee of a PACE provider.</text> </paragraph> <paragraph num="L."> <text>Any obligations of the PACE provider set forth in this chapter may be waived by the Department, but the waiver extends only to the particular case, time, and manner specified by the Department and is not a waiver of any other provision of this chapter.</text> </paragraph> <paragraph num="M."> <text>If the PACE Program Agreement exempts the PACE provider from financial responsibility for any services available under the State Plan, the PACE provider shall be required by the PACE Organization Provider Agreement to provide for these services.</text> </paragraph> <paragraph num="N."> <text>Liability.</text> <paragraph num="(1)"> <text>The PACE provider shall be wholly at risk for all medically necessary and appropriate services covered under the PACE provider benefit package.</text> </paragraph> <paragraph num="(2)"> <text>The Department may not make additional payment for services under this section.</text> </paragraph> <paragraph num="(3)"> <text>The PACE provider may not collect any payment from a PACE participant except as specified in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>The PACE provider is solely responsible for ensuring that it does not issue payments for services for which it is not liable in its PACE Organization Provider Agreement, and the Department may not accept responsibility for refunding to the PACE provider any excess payments made by the PACE provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Term of the PACE Organization Provider Agreement."> <paragraph num="A."> <text>The duration or term of the agreement between the Department and the PACE provider is specified in the PACE Organization Provider Agreement.</text> </paragraph> <paragraph num="B."> <text>The PACE Organization Provider Agreement shall provide for automatic amendment, renegotiation, or termination, or all of the above, of the PACE Organization Provider Agreement by either party if any part of the PACE Organization Provider Agreement's provider benefit package is changed under the State Plan.</text> </paragraph> <paragraph num="C."> <text>Termination.</text> <paragraph num="(1)"> <text>The Department may terminate immediately the PACE Organization Provider Agreement upon notification:</text> <paragraph num="(a)"> <text>By the U. S. Department of Health and Human Services, that it is withdrawing federal financial participation in all or part of the cost of the PACE benefit package;</text> </paragraph> <paragraph num="(b)"> <text>By the Department of Budget and Management, of the unavailability of sufficient State funds for the PACE benefit package; or</text> </paragraph> <paragraph num="(c)"> <text>That the owners or managers of the PACE provider, or other persons with substantial Medicaid Provider Agreement relationships with the PACE provider, have been convicted of certain crimes or received certain sanctions as specified in §1128 of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may, at its sole discretion, offer to renegotiate any provision of the PACE Organization Provider Agreement if renegotiation would remove any of the causes of termination specified in §C(1) of this regulation. This offer is not a waiver of the Department's right of immediate termination.</text> </paragraph> <paragraph num="(3)"> <text>The PACE Organization Provider Agreement may be terminated by either the Department or the PACE provider if the other party fails to meet a provision of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>The PACE Organization Provider Agreement; or</text> </paragraph> <paragraph num="(c)"> <text>Applicable laws, rules, regulations, or guidelines effective as of the date of the PACE Organization Provider Agreement or enacted or established during the PACE Organization Provider Agreement's term.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A PACE Organization Provider Agreement's termination is effective only after the terminating party has notified the breaching party in writing of the cause or causes of termination and has allowed 60 days for the correction or alleviation of the cause or causes by the breaching party.</text> </paragraph> <paragraph num="(5)"> <text>Termination of Agreement by PACE. The PACE provider may terminate an agreement after timely notice to CMS, the Department, and PACE participants, as follows:</text> <paragraph num="(a)"> <text>To CMS and the Department, 90 days before termination; and</text> </paragraph> <paragraph num="(b)"> <text>To PACE participants, 60 days before termination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Default by PACE.</text> <paragraph num="(1)"> <text>The Department may immediately terminate the PACE Organization Provider Agreement if the PACE provider defaults, as specified in §D(3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>If the PACE provider defaults, the Department may recover any capitation payments issued to the PACE provider for periods after the termination effective date of the PACE Organization Provider Agreement.</text> </paragraph> <paragraph num="(3)"> <text>The following are defaults by the PACE provider:</text> <paragraph num="(a)"> <text>Inability to provide the services described in the PACE provider benefit package and in Regulation .09 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Insolvency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Nonexclusivity of Remedy.</text> <paragraph num="(1)"> <text>This regulation's provisions supplement, rather than replace, any other sanctions or remedies available to the Department under the provisions of Regulation .24 of this chapter, the PACE Organization Provider Agreement, the Medicaid Provider Agreement, or applicable law or regulations.</text> </paragraph> <paragraph num="(2)"> <text>If the PACE Program Provider Agreement is terminated under this regulation, the PACE provider shall furnish to the Department, within 45 days of the termination's effective date, all information necessary for the reimbursement of any outstanding claims for services rendered to the PACE provider's participants, including claims of its contractors.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="PACE Participant Eligibility."> <paragraph num="A."> <text>An eligible person shall:</text> <paragraph num="(1)"> <text>Reside in the PACE approved service area upon enrollment;</text> </paragraph> <paragraph num="(2)"> <text>Be 55 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Be able to be maintained in a community-based setting with the assistance of PACE at the time of enrollment without jeopardizing the PACE participant's health or others' health or safety;</text> </paragraph> <paragraph num="(4)"> <text>Be determined by the Department to need the level of care required under the State Plan for coverage of nursing facility services for longer than 4 months; and</text> </paragraph> <paragraph num="(5)"> <text>Be willing to abide by the provision that requires PACE participants to receive all health and long-term care services exclusively from the PACE provider and its contracted or referred providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Assistance Eligibility Services.</text> <paragraph num="(1)"> <text>Medical Assistance eligibility for services under this chapter is determined under this regulation and applicable sections of COMAR 10.09.24, as cited in §B(2)—(4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Categorically Needy. An individual is eligible for services under this chapter as categorically needy if the individual is receiving Medical Assistance as:</text> <paragraph num="(a)"> <text>A recipient of Supplemental Security Income (SSI);</text> </paragraph> <paragraph num="(b)"> <text>A member of a low income family with children, as described in §1931 of the Social Security Act; or</text> </paragraph> <paragraph num="(c)"> <text>Any other type of categorically needy person in accordance with COMAR 10.09.24.03.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Optionally Categorically Needy.</text> <paragraph num="(a)"> <text>An individual is eligible for services under this chapter as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable:</text> <paragraph num="(i)"> <text>Income does not exceed 300 percent of the applicable payment rate for SSI; and</text> </paragraph> <paragraph num="(ii)"> <text>Resources do not exceed the SSI resource standard for one individual.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For the purpose of determining Medical Assistance eligibility for the optionally categorically needy:</text> <paragraph num="(i)"> <text>The individual is treated as an assistance unit of one individual; and</text> </paragraph> <paragraph num="(ii)"> <text>Countable income and resources are determined based on the rules for income and resources set forth in COMAR 10.09.24 as applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions in §B(3)(g) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An individual is not eligible under §B(3) of this regulation if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires.</text> </paragraph> <paragraph num="(d)"> <text>The spousal impoverishment rules in §1924 of the Social Security Act and COMAR 10.09.24.10-1 are applicable, except for the differences specified in this regulation.</text> </paragraph> <paragraph num="(e)"> <text>Medical Assistance eligibility shall be redetermined at least every 12 months.</text> </paragraph> <paragraph num="(f)"> <text>If the applicant or participant is not aged, blind, or determined disabled by the Social Security Administration, the Department of Human Services shall determine whether the applicant or participant is technically eligible for Medical Assistance as a disabled person, in accordance with COMAR 10.09.24.05-4B.</text> </paragraph> <paragraph num="(g)"> <text>All provisions of COMAR 10.09.24 which apply to an aged, blind, or disabled individual who is institutionalized are applicable to applicants and PACE participants under this chapter who are considered optionally categorically needy, with the following exceptions in full or in part:</text> <paragraph num="(i)"> <text>COMAR 10.09.24.04-1D and E;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.09.24.04-1F;</text> </paragraph> <paragraph num="(iii)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(iv)"> <text>COMAR 10.09.24.08F(1);</text> </paragraph> <paragraph num="(v)"> <text>COMAR 10.09.24.08G;</text> </paragraph> <paragraph num="(vi)"> <text>COMAR 10.09.24.09;</text> </paragraph> <paragraph num="(vii)"> <text>COMAR 10.09.24.10; and</text> </paragraph> <paragraph num="(viii)"> <text>COMAR 10.09.24.10-1.</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Home Exclusion. The home, as defined in COMAR 10.09.24.08F(1), is not a countable resource under §B(3) of this regulation if it is occupied by the applicant or PACE participant, the applicant's or PACE participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or PACE participant:</text> <paragraph num="(i)"> <text>Child;</text> </paragraph> <paragraph num="(ii)"> <text>Parent; or</text> </paragraph> <paragraph num="(iii)"> <text>Sibling.</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Medical Assistance eligibility shall be determined by the Department within 45 days after the Department or its representative receives a signed application according to COMAR 10.09.24.04-1D.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Post-Eligibility Determination of Available Income for Optionally Categorically Needy.</text> <paragraph num="(a)"> <text>The countable monthly income considered for the post eligibility determination is calculated in accordance with §B(3) of this regulation and COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified in COMAR 10.09.24.07L are not applied.</text> </paragraph> <paragraph num="(b)"> <text>For individuals eligible under §B(3) of this regulation who reside in a licensed assisted living facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order:</text> <paragraph num="(i)"> <text>A personal needs allowance of $60;</text> </paragraph> <paragraph num="(ii)"> <text>A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); and</text> </paragraph> <paragraph num="(iii)"> <text>Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g).</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For individuals who reside in an assisted living facility whose contribution toward the cost of service is calculated under §B(4)(b) of this regulation, the provider shall collect the PACE participant's available income. The amount collected under this paragraph may not exceed the monthly capitation amount under this chapter for the PACE participant.</text> </paragraph> <paragraph num="(d)"> <text>For individuals eligible under §B(3) of this regulation who reside in a long-term care facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order:</text> <paragraph num="(i)"> <text>A personal needs allowance in accordance with COMAR 10.09.24.10D(2)(c);</text> </paragraph> <paragraph num="(ii)"> <text>A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d);</text> </paragraph> <paragraph num="(iii)"> <text>A residential allowance in accordance with COMAR 10.09.24.10D(2)(e); and</text> </paragraph> <paragraph num="(iv)"> <text>Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g).</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For individuals who reside in a long-term care facility whose contribution toward the cost of service is calculated under §B(4)(d) of this regulation, the provider shall collect the PACE participant's available income.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Enrollment shall be on a voluntary basis, without respect to race, age greater than the lower limit required, creed, sex, color, national origin, marital status, or physical or mental handicap.</text> </paragraph> <paragraph num="D."> <text>An individual is not eligible for enrollment in PACE, regardless of whether the individual is otherwise eligible for benefits under the Program, if the individual is:</text> <paragraph num="(1)"> <text>Living outside the PACE provider's service area;</text> </paragraph> <paragraph num="(2)"> <text>Not included in the PACE provider's target population specified in the PACE Program Agreement; or</text> </paragraph> <paragraph num="(3)"> <text>Enrolled in:</text> <paragraph num="(a)"> <text>A managed care organization contracting with the Department;</text> </paragraph> <paragraph num="(b)"> <text>A Medicaid home and community-based services waiver under §1915(c) of the Social Security Act;</text> </paragraph> <paragraph num="(c)"> <text>Rare and expensive case management (REM) under COMAR 10.09.69; or</text> </paragraph> <paragraph num="(d)"> <text>A Medicaid capitated program that includes nursing facility or community-based long term care services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Pace Participant Enrollment."> <paragraph num="A."> <text>The Department shall enroll eligible persons who have chosen to enroll in the PACE provider.</text> </paragraph> <paragraph num="B."> <text>The PACE provider shall enter into an enrollment agreement with an eligible participant on the form approved by the Department.</text> </paragraph> <paragraph num="C."> <text>The PACE provider shall enroll eligible participants in the order in which they apply, and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures.</text> </paragraph> <paragraph num="D."> <text>Signature on Enrollment Forms.</text> <paragraph num="(1)"> <text>Except as indicated under §D(2) of this regulation, a participant 55 years old or older shall sign and submit the enrollment form;</text> </paragraph> <paragraph num="(2)"> <text>A legal guardian or legal representative shall sign enrollment forms for eligible persons determined to be incapacitated or incompetent to sign the form.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Because the PACE provider is responsible for ensuring that participants whose primary language is not English understand the benefits and restrictions associated with enrollment in PACE, the PACE provider shall give to such a participant at the time of enrollment a:</text> <paragraph num="(1)"> <text>Notice that translation services are available; or</text> </paragraph> <paragraph num="(2)"> <text>List of primary care providers who speak foreign languages.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Subject to verification of eligibility, enrollment shall be effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement.</text> </paragraph> <paragraph num="G."> <text>An individual eligible for enrollment under Regulation .05 of this chapter, may enroll at any time during the term of the PACE Provider Agreement, unless:</text> <paragraph num="(1)"> <text>Enrollment under the PACE Organization Provider Agreement has been suspended pursuant to Regulation .23 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>The PACE provider exceeds the enrollment limit established by the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The PACE provider shall:</text> <paragraph num="(1)"> <text>Maintain a list of all individuals denied enrollment in the order in which they applied for enrollment; and</text> </paragraph> <paragraph num="(2)"> <text>Promptly offer enrollment to denied individuals when permitted.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The PACE provider shall provide to each PACE participant an identification card, clearly indicating the bearer is enrolled with the PACE provider.</text> </paragraph> <paragraph num="J."> <text>The PACE provider shall provide in writing and explain to a new participant, at a minimum, the following:</text> <paragraph num="(1)"> <text>Notification of the PACE participant's right to terminate enrollment, the time frame required, and explanation of the required process; and</text> </paragraph> <paragraph num="(2)"> <text>Information about the proper utilization of pharmacy services including the requirement to use one pharmacy within the PACE provider network to fill all prescriptions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Termination of PACE Participant's Enrollment."> <paragraph num="A."> <text>Termination of a PACE participant's enrollment may be initiated by the:</text> <paragraph num="(1)"> <text>PACE provider;</text> </paragraph> <paragraph num="(2)"> <text>Department;</text> </paragraph> <paragraph num="(3)"> <text>PACE participant; or</text> </paragraph> <paragraph num="(4)"> <text>PACE participant’s legal guardian or legal representative.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All enrollment terminations require prior approval by the Department.</text> </paragraph> <paragraph num="C."> <text>General Requirements for Processing Disenrollments.</text> <paragraph num="(1)"> <text>The Department shall establish a timeline for the receipt of disenrollment forms as follows:</text> <paragraph num="(a)"> <text>A PACE participant’s involuntary disenrollment occurs after the PACE provider meets the requirements set forth in 42 CFR §460.164 and is effective on the first day of the next month that begins 30 days after the day the PACE organization sends notice of the disenrollment to the PACE participant; or</text> </paragraph> <paragraph num="(b)"> <text>A PACE participant’s voluntary disenrollment is effective on the first day of the month following the date the PACE organization receives the PACE participant’s notice of voluntary disenrollment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Disenrollment requests shall be submitted to the Department by the PACE provider within 3 working days from completion, except if the PACE participant requests that the form be mailed to the PACE participant's home address for completion.</text> </paragraph> <paragraph num="(3)"> <text>The PACE provider shall send the PACE participant a copy of the completed disenrollment forms, regardless of who initiated the disenrollment process.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Voluntary Disenrollment by PACE Participant.</text> <paragraph num="(1)"> <text>In general, PACE participants may disenroll from the PACE provider at their discretion at any time without cause, by completing or having completed by a legal guardian or legal representative a disenrollment form provided by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The PACE provider shall act to facilitate disenrollment, including mailing disenrollment request forms to PACE participants desiring to disenroll but having difficulty accessing the PACE provider's office.</text> </paragraph> <paragraph num="(3)"> <text>The PACE provider shall date-stamp PACE participants' disenrollment requests upon receipt.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disenrollment Initiated by the PACE Provider.</text> <paragraph num="(1)"> <text>The PACE provider shall have a written policy regarding termination of a PACE participant's enrollment by the PACE provider which shall address, at a minimum:</text> <paragraph num="(a)"> <text>Under what conditions a PACE participant is to be disenrolled by the PACE provider; and</text> </paragraph> <paragraph num="(b)"> <text>The time elements involved in processing terminations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A disenrollment initiated by the PACE provider shall require prior approval by the Department.</text> </paragraph> <paragraph num="(3)"> <text>A disenrollment may not occur because of an adverse change in the PACE participant's health status.</text> </paragraph> <paragraph num="(4)"> <text>The PACE participant's complete medical and utilization history shall be provided by the PACE provider to the Department, upon request, in order to determine an appropriate disenrollment date.</text> </paragraph> <paragraph num="(5)"> <text>The PACE provider shall notify the PACE participant within 14 days of when the disenrollment is approved, and the PACE participant may appeal the decision under the terms of COMAR 10.01.04.</text> </paragraph> <paragraph num="(6)"> <text>Disenrollment may be requested by the PACE provider by providing to the Department acceptable documentation that the:</text> <paragraph num="(a)"> <text>PACE participant's domicile was relocated outside the PACE provider's service area;</text> </paragraph> <paragraph num="(b)"> <text>PACE participant is no longer eligible in accordance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>PACE participant is discovered to be an individual for whom there existed legal documentation at the time of enrollment that the individual was mentally incompetent, but the PACE participant signed the enrollment form;</text> </paragraph> <paragraph num="(d)"> <text>PACE participant commits fraudulent or illegal acts, such as permitting use of the PACE participant's medical identification card by others, altering a prescription, theft or other criminal acts committed in any provider's or PACE provider's premises;</text> </paragraph> <paragraph num="(e)"> <text>PACE participant fails to complete and submit consents, releases, or assignments and other documents reasonably requested by the PACE provider in order to obtain or assure payment by Medicare, Medicaid, or other third party payers; or</text> </paragraph> <paragraph num="(f)"> <text>PACE participant has died.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A PACE provider requesting disenrollment based on documentation under §E(6)(d) of this regulation shall report any illegal acts to law enforcement authorities or to the Medicaid Fraud Control Unit of the Department's Recipient Fraud Unit as appropriate.</text> </paragraph> <paragraph num="(8)"> <text>If a request for disenrollment is approved, the PACE provider shall facilitate a PACE participant's enrollment into other programs by:</text> <paragraph num="(a)"> <text>Making appropriate referrals; and</text> </paragraph> <paragraph num="(b)"> <text>Ensuring clinical records are made available to new providers within 10 days of disenrollment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Disenrollment by the Department. The Department shall disenroll a PACE participant if the:</text> <paragraph num="(1)"> <text>PACE Organization Provider Agreement between the PACE provider and the Department is terminated;</text> </paragraph> <paragraph num="(2)"> <text>PACE participant dies;</text> </paragraph> <paragraph num="(3)"> <text>PACE participant becomes ineligible for enrollment in accordance with Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>PACE participant loses eligibility for Medical Assistance Program benefits or changes to a category of assistance not eligible for enrollment in PACE.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Effective Date of Termination.</text> <paragraph num="(1)"> <text>The Department shall approve or disapprove requests for voluntary disenrollment within 5 working days of the date the request is received.</text> </paragraph> <paragraph num="(2)"> <text>A disenrollment initiated by either the Department or the PACE provider because the participant died or became ineligible for enrollment for one of the other reasons specified in this regulation is effective the day after the event causing the ineligibility.</text> </paragraph> <paragraph num="(3)"> <text>For disenrollments initiated by the Department, the Department shall provide the PACE provider with written notice.</text> </paragraph> <paragraph num="(4)"> <text>A disenrollment resulting from the PACE participant's loss of Program eligibility shall be effective on the day following the PACE participant's last date of eligibility.</text> </paragraph> <paragraph num="(5)"> <text>The Department may recover any capitation payments made on behalf of the PACE participant for periods following the effective date of the PACE participant's termination of enrollment or loss of eligibility, but not for a retroactive period greater than 3 months except in the case of:</text> <paragraph num="(a)"> <text>The PACE participant's death; or</text> </paragraph> <paragraph num="(b)"> <text>The PACE participant's relocation of domicile outside the PACE provider's service area.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The Department may determine a retroactive disenrollment date based on the conditions present when the disenrollment is requested or indicated.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="PACE Participant Rights."> <text>The PACE provider shall ensure notification and protection of the rights of enrollees according to 42 CFR §460.110 and 42 CFR §460.112.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services."> <paragraph num="A."> <text>Except as limited or expanded by the PACE benefit package specified in the PACE program agreement, the PACE provider shall directly provide, arrange, purchase, or otherwise make available, as medically necessary and appropriate, the services specified in the State Plan and the PACE benefit package.</text> </paragraph> <paragraph num="B."> <text>The PACE benefit package for all PACE participants, regardless of the source of payment, shall include the following:</text> <paragraph num="(1)"> <text>All Medicaid-covered services, as specified in the State Plan;</text> </paragraph> <paragraph num="(2)"> <text>Multidisciplinary assessment and treatment planning;</text> </paragraph> <paragraph num="(3)"> <text>Social work services;</text> </paragraph> <paragraph num="(4)"> <text>Nutritional counseling;</text> </paragraph> <paragraph num="(5)"> <text>Recreational therapy;</text> </paragraph> <paragraph num="(6)"> <text>Certain meals;</text> </paragraph> <paragraph num="(7)"> <text>Medical specialty services;</text> </paragraph> <paragraph num="(8)"> <text>Prosthetics, orthotics, corrective vision devices, such as eyeglasses and lenses, hearing aids, dentures, and repair and maintenance of these items;</text> </paragraph> <paragraph num="(9)"> <text>Assisted living; and</text> </paragraph> <paragraph num="(10)"> <text>Other services determined necessary by the multidisciplinary team to improve and maintain the PACE participant's overall health status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For access, including access to emergency services, the PACE provider shall comply with 42 CFR §460.100.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Limitations on Coverage."> <text>Limitations on coverage are as specified in the PACE program agreement and 42 CFR §460.96.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Authorization Requirements."> <text>The PACE provider shall obtain approval by the Department before any changes in the following:</text> <paragraph num="A."> <text>Service contract agreements;</text> </paragraph> <paragraph num="B."> <text>PACE provider benefit package;</text> </paragraph> <paragraph num="C."> <text>PACE provider's service area;</text> </paragraph> <paragraph num="D."> <text>PACE provider's enrollment limit;</text> </paragraph> <paragraph num="E."> <text>PACE Organization Provider Agreement; or</text> </paragraph> <paragraph num="F."> <text>PACE provider structure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Marketing and Information."> <paragraph num="A."> <text>The PACE Organization Provider Agreement shall specify the methods by which the PACE provider will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or potential PACE participants.</text> </paragraph> <paragraph num="B."> <text>The PACE provider's marketing plan and all marketing procedures and materials require approval by the Department before implementation and utilization.</text> </paragraph> <paragraph num="C."> <text>The PACE provider may not participate in:</text> <paragraph num="(1)"> <text>Activities described in 42 CFR §460.82(e); or</text> </paragraph> <paragraph num="(2)"> <text>Face-to-face or telephone contact with a participant, or otherwise soliciting a participant who is not a PACE provider’s participant, unless authorized by the Department or initiated by the participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subject to prior approval by the Department, a PACE provider may engage in marketing activities designed to make [recipient] participants aware of the PACE provider's availability as well as any special services offered. Addressee-blind informational mailings to an entire zip code may be used.</text> </paragraph> <paragraph num="E."> <text>Enrollment Agreement and PACE Participant Enrollment Materials.</text> <paragraph num="(1)"> <text>The PACE provider shall distribute the enrollment agreement within 14 days of the PACE participant's effective date of coverage with the PACE Program.</text> </paragraph> <paragraph num="(2)"> <text>At a minimum the information in the enrollment agreement shall contain the following PACE participant enrollment materials which shall remain with the PACE participant:</text> <paragraph num="(a)"> <text>Location or locations and office hours of the PACE providers;</text> </paragraph> <paragraph num="(b)"> <text>Telephone number or numbers to call for more information;</text> </paragraph> <paragraph num="(c)"> <text>Choice and use of primary care providers and policies on changing primary care providers;</text> </paragraph> <paragraph num="(d)"> <text>How to access urgent care services and advice;</text> </paragraph> <paragraph num="(e)"> <text>How and when to use emergency services including ambulance;</text> </paragraph> <paragraph num="(f)"> <text>Information on the grievance and appeals process, including confidentiality and requesting an administrative hearing;</text> </paragraph> <paragraph num="(g)"> <text>How to access interpreter services including sign interpreters;</text> </paragraph> <paragraph num="(h)"> <text>PACE participant rights and responsibilities;</text> </paragraph> <paragraph num="(i)"> <text>PACE participant's possible responsibility for charges including Medicare deductibles and coinsurances if the participant goes outside of the PACE Program for nonemergency care, or obtains noncovered services or services not authorized by the interdisciplinary team;</text> </paragraph> <paragraph num="(j)"> <text>A clear statement that plan of care decisions are determined by the participant's interdisciplinary team;</text> </paragraph> <paragraph num="(k)"> <text>Information on the availability of social services and assistance in placement in community-based housing and facilities;</text> </paragraph> <paragraph num="(l)"> <text>Information on advance directives and physician order for life sustaining treatment;</text> </paragraph> <paragraph num="(m)"> <text>How to obtain copies of the PACE participant's records;</text> </paragraph> <paragraph num="(n)"> <text>How to obtain nonemergency ambulance services and other medical transportation to appointments, as appropriate;</text> </paragraph> <paragraph num="(o)"> <text>Explanation of covered and noncovered services;</text> </paragraph> <paragraph num="(p)"> <text>How to obtain prescriptions; and</text> </paragraph> <paragraph num="(q)"> <text>Confidentiality policy.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The PACE provider shall review the enrollment agreement for accuracy at least yearly and update it with new or corrected information as needed to reflect the PACE provider's internal changes and regulatory changes. If changes impact the PACE participants' ability to use services or benefits, the PACE provider shall distribute the updated materials to all PACE participants after approval by the Department.</text> </paragraph> <paragraph num="(4)"> <text>The provider shall offer orientation to the PACE program to new participants in person within 30 days of enrollment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Quality Assurance and Improvement Systems."> <paragraph num="A."> <text>The PACE provider shall comply with 42 CFR Part 460, Subpart H (Quality Assessment and Performance Improvement).</text> </paragraph> <paragraph num="B."> <text>The PACE provider shall comply with requirements designated by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Record Keeping."> <text>The PACE provider shall comply with 42 CFR §460.210.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Reports and Data Collection."> <paragraph num="A."> <text>The PACE provider shall collect and submit to the Department service-specific encounter data by service type in the format and at the frequency designated by the Department and in conformance with the Department's computer coding requirements.</text> </paragraph> <paragraph num="B."> <text>Encounter data submitted by PACE providers under §A of this regulation shall include, at a minimum:</text> <paragraph num="(1)"> <text>PACE participant and provider identifying information;</text> </paragraph> <paragraph num="(2)"> <text>Service, procedure, and diagnosis codes;</text> </paragraph> <paragraph num="(3)"> <text>Allowed, paid, and third-party liability amounts; and</text> </paragraph> <paragraph num="(4)"> <text>Service, claims submission, adjudication, and payment dates.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The PACE provider shall prepare and submit to the Department reports related to third-party liability as required by Regulation .20 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The PACE provider shall immediately notify the Department if it has knowledge of a PACE participant's death.</text> </paragraph> <paragraph num="E."> <text>The PACE provider shall have an effective procedure for reporting to the Department the following information:</text> <paragraph num="(1)"> <text>Patterns of utilization;</text> </paragraph> <paragraph num="(2)"> <text>Health status of PACE participants; and</text> </paragraph> <paragraph num="(3)"> <text>Appeals and grievances made by PACE participants.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Quarterly Reports. A PACE provider shall submit to the Department quarterly, within 30 days of the close of each calendar quarter, and in a format designated by the Department:</text> <paragraph num="(1)"> <text>Financial reports specified by the PACE program agreement;</text> </paragraph> <paragraph num="(2)"> <text>Quality assurance reports including, but not limited, to quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities;</text> </paragraph> <paragraph num="(3)"> <text>Grievance reports, including emergency room based grievances, as specified in Regulation .19 of this chapter that contain</text> <paragraph num="(a)"> <text>An analysis of PACE participant appeal and grievance records;</text> </paragraph> <paragraph num="(b)"> <text>Identification of significant trends or anomalies;</text> </paragraph> <paragraph num="(c)"> <text>The root causes of the trend or anomaly; and</text> </paragraph> <paragraph num="(d)"> <text>Actions taken to address the trend or anomaly;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A list of all pre-service denials or reduction of services or benefits issued by the PACE provider or subcontractors during the preceding quarter; and</text> </paragraph> <paragraph num="(5)"> <text>A report of the PACE provider’s participant advisory committee outlining the committee’s activities and recommendations.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Annual Reports. The PACE provider shall submit to the Department annually, within 90 days after the end of the calendar year:</text> <paragraph num="(1)"> <text>An annual summary of the information required by §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Any revisions to the PACE provider's quality assurance or utilization management plans;</text> </paragraph> <paragraph num="(3)"> <text>A copy of any changes in contractor agreements;</text> </paragraph> <paragraph num="(4)"> <text>On-site proof that the PACE provider has obtained adequate insurance coverage, issued by an insurer authorized by the Maryland Insurance Administration to engage in the insurance business in the State, to protect its financial viability, and its ability to carry out its PACE program agreement obligations, including at a minimum:</text> <paragraph num="(a)"> <text>Malpractice coverage for all professional and related employees of the PACE provider, as well as for the PACE provider itself;</text> </paragraph> <paragraph num="(b)"> <text>Bonding of all employees and officers who have any responsibilities for the accounting and financial management activities of the PACE provider; and</text> </paragraph> <paragraph num="(c)"> <text>Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A proposed budget and financial plan for the PACE provider's operation, including:</text> <paragraph num="(a)"> <text>An annualized cash flow chart;</text> </paragraph> <paragraph num="(b)"> <text>The cost of operations;</text> </paragraph> <paragraph num="(c)"> <text>Information demonstrating that the PACE provider has a fiscally sound operation; and</text> </paragraph> <paragraph num="(d)"> <text>A statement of policy and procedures for accounting, capitation collection, methods of reimbursing providers and contractors, and method of payment for emergency and out-of-area claims; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Financial monitoring reports, including any supplemental schedules required by the Department, prepared according to the criteria and reporting instructions and in the format and pursuant to the schedule required by the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>For the purposes of Program administration or monitoring of the PACE provider's performance pursuant to this chapter, given a reasonable period of notice, the PACE provider shall supply other information the Department may request from time to time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Confidentiality."> <paragraph num="A."> <text>Subject to the requirements of 42 CFR Part 431 Subpart F, the PACE provider and its contractors may not release or disclose any information concerning a PACE participant to anyone other than the Department except with the written permission of the:</text> <paragraph num="(1)"> <text>PACE participant; or</text> </paragraph> <paragraph num="(2)"> <text>PACE participant's attorney, legal representative, or legal guardian.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For all information, records, data, and data elements collected and maintained by the PACE provider to facilitate operations under this chapter, the PACE provider shall:</text> <paragraph num="(1)"> <text>Protect this information, records, data, and data elements from unauthorized disclosure, in accordance with the provisions of applicable federal and State laws and regulations; and</text> </paragraph> <paragraph num="(2)"> <text>Assure that access is limited by the PACE provider to persons or agencies requiring the information to perform their duties in accordance with this chapter or other duties authorized by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Financial Solvency."> <text>The PACE provider shall comply with 42 CFR §460.80 and 42 CFR §460.208.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Subcontractual Relationships."> <paragraph num="A."> <text>Consistent with this chapter, the PACE provider, in performing its obligations under this chapter and the PACE program agreement, may either engage its own employees and agents or utilize the services of persons, firms, and other entities by means of contractual relationships.</text> </paragraph> <paragraph num="B."> <text>The PACE provider shall have a contractor agreement for all services which are not provided directly by the PACE provider through its own employees and agents.</text> </paragraph> <paragraph num="C."> <text>A contractor agreement may not diminish or alter the legal responsibility of the PACE provider to the Department to assure that all obligations under this chapter and the PACE program agreement are carried out.</text> </paragraph> <paragraph num="D."> <text>All service contractor agreements require preapproval by the Department.</text> </paragraph> <paragraph num="E."> <text>If there are proposed changes in a contractor agreement with any contractor, the full contractor agreement shall be submitted to the Department for prior approval.</text> </paragraph> <paragraph num="F."> <text>If the Department determines that termination or expiration of a PACE provider's contractual relationship materially affects the PACE provider's ability to carry out its responsibilities under the PACE [provider agreement] Organization Provider Agreement, the Department may terminate the PACE Organization Provider Agreement.</text> </paragraph> <paragraph num="G."> <text>The PACE provider may contract for any health care services not furnished directly by PACE in its benefit package to a health care provider that is licensed, certified, and meets Medicaid and Medicare participation requirements.</text> </paragraph> <paragraph num="H."> <text>Contractors shall be legally and professionally qualified to furnish the services set forth in the contractor agreement in return for the compensation set forth in the contractor agreement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Internal Grievance Procedure."> <text>The PACE provider shall comply with the grievance procedures described at 42 CFR §460.120—124.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Third-Party Liability."> <paragraph num="A."> <text>The PACE provider shall identify and collect money owed from responsible third parties liable for the cost of health care services furnished by the PACE provider to its PACE participants.</text> </paragraph> <paragraph num="B."> <text>Upon request from the Department, the PACE provider shall convey any information regarding third-party liability to the Department and the U.S. Department of Health and Human Services.</text> </paragraph> <paragraph num="C."> <text>If both the Department and the PACE provider have a right of subrogation, the Department and the PACE provider shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount.</text> </paragraph> <paragraph num="D."> <text>For insurance coverage identified by the PACE provider with a retroactive effective date, the PACE provider shall ensure that procedures are in place for the collection of funds from either the provider or the insurance carrier for claims paid by the PACE provider during the coverage period, for up to 2 years from the date of health care services provided to the participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Payment Rates and Procedures."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Pay the PACE provider for each PACE participant based on the fixed capitation payment or payments specified in §E of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Calculate the capitation payment or payments for the PACE provider using the methodology described in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Calculation of PACE Capitation Payments.</text> <paragraph num="(1)"> <text>PACE capitation payments are calculated on a per-member per-month basis.</text> </paragraph> <paragraph num="(2)"> <text>Capitation payments are specific to both the regional service area, as described in §C of this regulation, and the participant age and coverage status, as described in §D of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Capitation payments are calculated using an AWOP analysis, which is determined using a base period of Medicaid fee for service participant data that:</text> <paragraph num="(a)"> <text>Spans two State fiscal years;</text> </paragraph> <paragraph num="(b)"> <text>Is specific to the PACE eligible population;</text> </paragraph> <paragraph num="(c)"> <text>Is weighted by the expected ratio of participants receiving long-term care services in institutional and community-based settings; and</text> </paragraph> <paragraph num="(d)"> <text>Excludes participants enrolled in the following programs:</text> <paragraph num="(i)"> <text>Medicaid managed care programs;</text> </paragraph> <paragraph num="(ii)"> <text>PACE; and</text> </paragraph> <paragraph num="(iii)"> <text>Home and community-based services waivers operated by the Developmental Disabilities Administration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department shall set the PACE capitation rate as 98 percent of the calculated AWOP.</text> </paragraph> <paragraph num="(5)"> <text>The Department shall recalculate PACE capitation rates annually by trending forward the base period by 1 year.</text> </paragraph> <paragraph num="(6)"> <text>Certain categories of costs not associated with a PACE-eligible, nursing facility-certified population are excluded from the claims data.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Capitation rates shall be categorized by regional service area as follows:</text> <paragraph num="(1)"> <text>Baltimore Metro — Baltimore City and Anne Arundel, Baltimore, Carroll, Cecil, Harford, and Howard counties;</text> </paragraph> <paragraph num="(2)"> <text>Washington Metro — Calvert, Charles, Frederick, Montgomery, Prince George’s, and St. Mary’s counties; and</text> </paragraph> <paragraph num="(3)"> <text>Rural Regions — Allegany, Caroline, Dorchester, Garrett, Kent, Queen Anne’s, Somerset, Talbot, Washington, Wicomico, and Worcester counties.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Capitation rates shall be categorized by participant age and coverage status as follows:</text> <paragraph num="(1)"> <text>Ages 55—64, Medicaid-only;</text> </paragraph> <paragraph num="(2)"> <text>Ages 65 and over, Medicaid-only;</text> </paragraph> <paragraph num="(3)"> <text>Ages 55—64, dual eligibility; and</text> </paragraph> <paragraph num="(4)"> <text>Ages 65 and over, dual eligibility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>For services provided on or after January 1, 2024, the Department shall pay the PACE provider at the following per-member per-month capitation rates:</text> </paragraph> <paragraph num="F."> <text>The capitation rate paid by the Department to the PACE provider for a participant shall be accepted as payment in full for the PACE provider benefit package provided by the PACE provider according to its PACE Organization Provider Agreement, and additional charge may not be made to the participant, the Department, or any other entity except as provided under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="G."> <text>The Department shall recover any overpayments made to the PACE provider.</text> </paragraph> <paragraph num="H."> <text>A capitation payment may not be made to the PACE provider on behalf of a participant for whom fee-for-service or a capitation payment for the same period has been made by the Department to any other provider, HMO, or managed care organization.</text> </paragraph> <paragraph num="I."> <text>Capitation payment may not be made to the PACE provider on behalf of a participant if the Department's eligibility verification system indicates that the participant is not eligible for Medicaid benefits.</text> </paragraph> <paragraph num="J."> <text>The Department shall provide retroactive capitation to the PACE provider on behalf of a participant when:</text> <paragraph num="(1)"> <text>The Department's eligibility verification system indicates that the participant has established a retroactive eligibility period to a previous PACE enrollment period; and</text> </paragraph> <paragraph num="(2)"> <text>Services were provided by the PACE provider and no other fee-for-service provider.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Program Changes.</text> <paragraph num="(1)"> <text>Amendments, revisions, or additions to the State Plan or the State or federal regulations, guidelines, or policies shall, insofar as they affect the scope or nature of Program benefits available to eligible persons, be considered as amendments to the PACE provider benefit package, unless the Department shall otherwise notify the PACE provider.</text> </paragraph> <paragraph num="(2)"> <text>The Department or PACE may determine that a change in the PACE provider benefit package, or in the Program's reporting or other administrative requirements, is a substantial modification of the financial or other responsibilities of the PACE provider, and so may request an adjustment in the PACE provider's capitation payment.</text> </paragraph> <paragraph num="(3)"> <text>Refusal of an adjustment in the PACE provider's capitation payment by the other party shall, at the discretion of the party making the request, be grounds for termination of the PACE Organization Provider Agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Payment for Emergency Services."> <paragraph num="A."> <text>The PACE provider shall be responsible for prompt payment for all emergency services received by PACE participants.</text> </paragraph> <paragraph num="B."> <text>If a claim is submitted to the PACE provider within 9 months of the date of service, the PACE provider shall reimburse a hospital emergency facility and provider or free-standing urgent care center, without requiring prior authorization or approval for payment from the PACE provider, for:</text> <paragraph num="(1)"> <text>Emergency services;</text> </paragraph> <paragraph num="(2)"> <text>Medical screening services rendered at an emergency facility to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; and</text> </paragraph> <paragraph num="(3)"> <text>Medically necessary and appropriate services if:</text> <paragraph num="(a)"> <text>The PACE provider authorized, referred, or otherwise allowed the PACE participant to use the emergency facility; and</text> </paragraph> <paragraph num="(b)"> <text>The services are related to the condition for which the PACE participant was allowed to use the emergency facility.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may:</text> <paragraph num="(1)"> <text>Impose one or more of the actions under COMAR 10.09.36.08A; and</text> </paragraph> <paragraph num="(2)"> <text>Suspend the PACE provider’s ability to enroll new PACE participants.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Appeal Procedures."> <paragraph num="A."> <text>The PACE provider shall comply with 42 CFR §460.122.</text> </paragraph> <paragraph num="B."> <text>PACE provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09.</text> </paragraph> <paragraph num="C."> <text>PACE participant appeals are set forth in COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Interpretive Regulation."> <text>Interpretation of this regulation is subject to COMAR 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.25 adopted as an emergency provision effective November 1, 2002 (29:25 Md. R. 1979); adopted permanently effective April 28, 2003 (30:8 Md. R. 540)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652); August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 29, 2018 (45:2 Md R. 68); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18F amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective August 19, 2024 (51:16 Md, R. 742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23B amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24C amended effective July 21, 2025 (52:14 Md. R. 713)</annotation> </annotations> </chapter> <chapter num="45" heading="Mental Health Case Management: Care Coordination for Adults"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to providers organized to deliver mental health case management services to adults.</text> </paragraph> <paragraph num="B."> <text>The purpose of mental health case management is to assist participants in gaining access to needed medical, mental health, social, educational, and other services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative services organization (ASO)” means the entity with which the Mental Hygiene Administration may contract to provide the services described in COMAR 10.09.70 for the public mental health system.</text> </paragraph> <paragraph num="(2)"> <text>“Adult” means an individual 18 years and older.</text> </paragraph> <paragraph num="(3)"> <text>“Care plan” means the plan prepared according to the requirements outlined in this chapter that delineate the plan of care for a specific participant.</text> </paragraph> <paragraph num="(4)"> <text>“Case manager” means a community support specialist.</text> </paragraph> <paragraph num="(5)"> <text>“Community support specialist” means an individual who is employed by a mental health case management provider to deliver case management services to participants.</text> </paragraph> <paragraph num="(6)"> <text>“Community support specialist associate” means an individual who is employed by a mental health case management provider to assist community support specialists in the provision of mental health case management services to participants.</text> </paragraph> <paragraph num="(7)"> <text>“Community support specialist supervisor” means an individual who is employed or under contract to supervise case management services.</text> </paragraph> <paragraph num="(8)"> <text>“Core service agency (CSA)” has the meaning stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="(9)"> <text>“Department” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(11)"> <text>“Mental health case management provider” means a provider that:</text> <paragraph num="(a)"> <text>Is approved under this chapter to provide mental health case management services to adults 18 years or older; and</text> </paragraph> <paragraph num="(b)"> <text>Utilizes a collaborative process of assessment, planning, implementation, coordination, monitoring, and evaluation of the options and services required to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Mental health case management services” means services covered under this chapter which assist participants in gaining access to the full range of mental health services, as well as to any additional needed medical, social, financial assistance, counseling, educational, housing, and other support services.</text> </paragraph> <paragraph num="(13)"> <text>“Mental health professional” has the meaning stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="(14)"> <text>“Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A.</text> </paragraph> <paragraph num="(15)"> <text>“Mental Hygiene Administration (MHA)” means the Department's administration that is charged with the responsibility for providing services to mentally ill individuals, as defined in Health-General Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Nonparticipant” means an individual who does not meet the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(17)"> <text>“Participant” means an individual who meets the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(18)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(19)"> <text>“Provider” means the mental health case management services provider.</text> </paragraph> <paragraph num="(20)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(21)"> <text>“Serious and persistent mental disorder” means a disorder that is:</text> <paragraph num="(a)"> <text>Manifested in an individual 18 years old or older; and</text> </paragraph> <paragraph num="(b)"> <text>Diagnosed, according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary as:</text> <paragraph num="(i)"> <text>Schizophrenic disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Major affective disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Other psychotic disorder; or</text> </paragraph> <paragraph num="(iv)"> <text>Borderline or schizotypal personality disorders, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Unit of service” means a per day rate for a minimum of 1 hour per day for contacts, including face-to-face contacts with a participant, and non-face-to-face contacts on behalf of the participant with nonparticipants, that are directly related to identifying the needs and supports for helping the individual to access services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>A recipient is eligible for mental health case management services if the recipient:</text> <paragraph num="(1)"> <text>Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and</text> </paragraph> <paragraph num="(2)"> <text>Has a serious and persistent mental health disorder and is:</text> <paragraph num="(a)"> <text>In, at risk of, or needs continued community treatment to prevent, inpatient psychiatric treatment;</text> </paragraph> <paragraph num="(b)"> <text>At risk of, or needs continued community treatment to prevent, being homeless; or</text> </paragraph> <paragraph num="(c)"> <text>At risk of incarceration or who will be released from a detention center or prison.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Specific Diagnostic Criteria. The specific diagnostic criteria may be waived if an individual is:</text> <paragraph num="(1)"> <text>Committed as not criminally responsible and is conditionally released from a Mental Hygiene Administration (MHA) facility, according to the provisions of Health-General Article, Title 12, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>In a MHA facility, or is a MHA-funded individual in a psychiatric inpatient hospital who requires community services, excluding individuals who are eligible for Developmental Disabilities Administration's residential services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Eligible individuals transitioning from institutions as described in either §B(1) or (2) of this regulation to a community-based setting may receive case management services for up to 180 consecutive days of the covered stay in the institution.</text> </paragraph> <paragraph num="D."> <text>Levels of Care.</text> <paragraph num="(1)"> <text>In addition to meeting the eligibility criteria outlined under §§A and B of this regulation, participants shall be classified according to the levels of care listed in §D(2) or (3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Level I—General. For a maximum of 2 units of service per month and based on the severity of the participant's mental illness, the participant shall meet at least one of the following conditions:</text> <paragraph num="(a)"> <text>The participant is not linked to mental health and medical services;</text> </paragraph> <paragraph num="(b)"> <text>The participant lacks basic supports for shelter, food, and income;</text> </paragraph> <paragraph num="(c)"> <text>The participant is transitioning from one level of care to another level of care; or</text> </paragraph> <paragraph num="(d)"> <text>The participant needs case management services to maintain community-based treatment and services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Level II—Intensive. For a maximum of 5 units of service per month and based on the severity of the participant's mental illness, the participant shall meet two or more of the following conditions:</text> <paragraph num="(a)"> <text>The participant is not linked to mental health and medical services;</text> </paragraph> <paragraph num="(b)"> <text>The participant lacks basic supports for shelter, food, and income;</text> </paragraph> <paragraph num="(c)"> <text>The participant is transitioning from one level of care to another level of care; or</text> </paragraph> <paragraph num="(d)"> <text>The participant needs case management services to maintain community-based treatment and services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A participant may not be enrolled in Mental Health Case Management for Adults while receiving services under COMAR 10.09.90 or 10.09.33.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Mental Health Case Management Provider Participation."> <paragraph num="A."> <text>The local core service agencies shall select mental health case management providers through a competitive procurement process, at least once every 5 years.</text> </paragraph> <paragraph num="B."> <text>Mental health case management services may be provided by local health departments according to COMAR 10.04.04, which allows the Director of the MHA to utilize the local health departments as vendors unless the health officer believes the service provided by alternate vendors would be preferable.</text> </paragraph> <paragraph num="C."> <text>Providers of mental health case management shall:</text> <paragraph num="(1)"> <text>Be approved or licensed in Maryland as a community mental health provider under COMAR 10.21.19, 10.21.20, 10.21.21, or 10.21.29, or have 3 years experience as a mental health case management provider; and</text> </paragraph> <paragraph num="(2)"> <text>Have at least 3 years experience providing mental health services, including serving high risk populations, to adults with serious mental illness.</text> </paragraph> </paragraph> <paragraph num="D."> <text>General Requirements. To be eligible to be approved as a mental health case management service provider, an entity shall meet all of the:</text> <paragraph num="(1)"> <text>Conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(2)"> <text>Medical Assistance provisions listed in COMAR designated for their provider type.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Specific Requirements. A mental health case management service provider:</text> <paragraph num="(1)"> <text>May not place restrictions on the qualified recipient's right to elect to or decline to:</text> <paragraph num="(a)"> <text>Receive mental health case management as authorized by the Department or the Department's designee; and</text> </paragraph> <paragraph num="(b)"> <text>Choose a community support specialist or associate, as approved by the Department or the Department's designee, and other medical care providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall employ appropriately qualified individuals as community support specialists, community support specialist associates, and community support specialist supervisors with relevant work experience, including experience with the target population, including but not limited to adults with a serious and persistent mental disorder;</text> </paragraph> <paragraph num="(3)"> <text>Shall assure that:</text> <paragraph num="(a)"> <text>A participant's initial assessment is completed within 20 days after the participant has been authorized by the ASO and determined eligible for, and has elected to receive, mental health case management services; and</text> </paragraph> <paragraph num="(b)"> <text>An initial care plan is completed within 10 days after completion of the initial assessment;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall maintain a file for each participant which includes all of the following:</text> <paragraph num="(a)"> <text>An initial referral and intake form with identifying information, including, but not limited to, the individual's name and Medicaid identification number;</text> </paragraph> <paragraph num="(b)"> <text>A written agreement for services signed by the participant or the participant's legally authorized representative and by the participant's community support specialist;</text> </paragraph> <paragraph num="(c)"> <text>An assessment as specified in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>A care plan, updated at a minimum of every 6 months, which contains at a minimum:</text> <paragraph num="(i)"> <text>A description of the participant's strengths and needs;</text> </paragraph> <paragraph num="(ii)"> <text>The diagnosis established as evidence of the participant's eligibility for services under this chapter;</text> </paragraph> <paragraph num="(iii)"> <text>The goals of case management services, with expected target dates;</text> </paragraph> <paragraph num="(iv)"> <text>The proposed intervention;</text> </paragraph> <paragraph num="(v)"> <text>Designation of the community support specialist with primary responsibility for implementation of the care plan; and</text> </paragraph> <paragraph num="(vi)"> <text>Signatures of the community support specialist, participant, or the participant's legally authorized representative, and significant others, if appropriate;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>An ongoing record of contacts made on the participant's behalf, which includes all of the following:</text> <paragraph num="(i)"> <text>Date and subject of contact;</text> </paragraph> <paragraph num="(ii)"> <text>Individual contacted;</text> </paragraph> <paragraph num="(iii)"> <text>Signature of community support specialist or community support specialist associate making the contact;</text> </paragraph> <paragraph num="(iv)"> <text>Nature, content, and unit or units of service provided;</text> </paragraph> <paragraph num="(v)"> <text>Place of service;</text> </paragraph> <paragraph num="(vi)"> <text>Whether goals specified in the care plan have been achieved;</text> </paragraph> <paragraph num="(vii)"> <text>The timeline for obtaining needed services;</text> </paragraph> <paragraph num="(viii)"> <text>The timeline for reevaluation of the plan; and</text> </paragraph> <paragraph num="(ix)"> <text>The need for and occurrences of coordination with other case managers; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Monthly summary notes, which reflect progress made towards the participant's stated goals;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shall have formal written policies and procedures, approved by the Department, or the Department's designee, which specifically address the provision of mental health case management services to participants in accordance with the requirements of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Shall be available to participants and, as appropriate, their families for 24 hours a day, 7 days a week in order to refer:</text> <paragraph num="(a)"> <text>Participants to needed services and supports; and</text> </paragraph> <paragraph num="(b)"> <text>In a psychiatric emergency, participants to mental health treatment and evaluation services in order to prevent the participant from accessing a higher level of care;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Shall document in the participant's case management records if the participant declines case management services;</text> </paragraph> <paragraph num="(8)"> <text>May not provide other services to participants which would be viewed by the Department as a conflict of interest;</text> </paragraph> <paragraph num="(9)"> <text>Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants;</text> </paragraph> <paragraph num="(10)"> <text>Shall maintain information on current resources for mental health, medical, social, financial assistance, vocational, educational, housing, and other support services;</text> </paragraph> <paragraph num="(11)"> <text>Shall safeguard the confidentiality of the participant's records in accordance with State and federal laws and regulations governing confidentiality;</text> </paragraph> <paragraph num="(12)"> <text>Shall comply with the Department's fiscal reporting requirements and submit reports in the manner specified by the Department;</text> </paragraph> <paragraph num="(13)"> <text>Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual's access to other services; and</text> </paragraph> <paragraph num="(14)"> <text>Shall assure the amount, duration, and scope of the case management activities are documented in a participant's care plan, which includes mental health case management activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mental Health Case Management Provider Staff."> <text>Required Staff. The mental health case management provider shall have staff that is sufficient in numbers and qualifications to provide appropriate services to the participants served and shall include, at a minimum:</text> <paragraph num="A."> <text>A community support specialist supervisor who:</text> <paragraph num="(1)"> <text>Is a mental health professional who is licensed and legally authorized to practice under the Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of:</text> <paragraph num="(a)"> <text>Social work;</text> </paragraph> <paragraph num="(b)"> <text>Professional Counseling;</text> </paragraph> <paragraph num="(c)"> <text>Psychology;</text> </paragraph> <paragraph num="(d)"> <text>Nursing;</text> </paragraph> <paragraph num="(e)"> <text>Occupational Therapy; or</text> </paragraph> <paragraph num="(f)"> <text>Medicine;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has 1 year of experience in mental health working as a supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Provides clinical consultation and training to community support specialists or associates regarding mental illness; and</text> </paragraph> <paragraph num="(4)"> <text>Is employed or contracted to supervise case management services at a ratio of one supervisor to every eight community support specialists or associates;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A community support specialist who:</text> <paragraph num="(1)"> <text>Has at least a:</text> <paragraph num="(a)"> <text>Bachelor's degree in a mental health field and 1 year of mental health experience, including mental health peer support; or</text> </paragraph> <paragraph num="(b)"> <text>Bachelor's degree in a field other than mental health and 2 years of mental health experience, including mental health peer support;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is chosen as the case manager by the participant or the participant's legally authorized representative; and</text> </paragraph> <paragraph num="(3)"> <text>Is employed by the mental health case management provider to provide case management services to participants; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>A community support specialist associate who:</text> <paragraph num="(1)"> <text>Has at least a high school degree or the equivalent, and 2 years of experience with individuals with mental illness, including mental health peer support;</text> </paragraph> <paragraph num="(2)"> <text>Is employed by the mental health case management provider to assist community support specialists in the provision of mental health case management services to participants; and</text> </paragraph> <paragraph num="(3)"> <text>Works under the supervision of a community support specialist who delegates specific tasks to the associate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>The Department shall reimburse for the services in §§C—I of this regulation under mental health case management when these services have been documented, pursuant to the requirements in this chapter, as necessary.</text> </paragraph> <paragraph num="B."> <text>Case management services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities.</text> </paragraph> <paragraph num="C."> <text>Comprehensive Assessment and Periodic Reassessment.</text> <paragraph num="(1)"> <text>Assessment or reassessment involves the participant's stated needs and review of information concerning the participant's mental health, social, familial, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a care plan.</text> </paragraph> <paragraph num="(2)"> <text>The assessment or reassessment of the participant’s stated needs and service needs is conducted by the community support specialist and incorporates input from the participant, family members, and friends of the participant, as appropriate, and community service providers, such as mental health providers, medical providers, social workers, and educators, if necessary.</text> </paragraph> <paragraph num="(3)"> <text>A home visit, or visit at another location suitable to the participant's needs, by the community support specialist or community support specialist associate is required every 90 days.</text> </paragraph> <paragraph num="(4)"> <text>After an initial assessment, each participant shall be reassessed every 6 months.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Development and Periodic Revision of a Specific Care Plan.</text> <paragraph num="(1)"> <text>After the initial assessment is completed, a care plan shall be developed.</text> </paragraph> <paragraph num="(2)"> <text>After the care plan is developed, it shall be updated every 6 months in conjunction with the participant's schedule for reassessments, to ensure that all services being provided remain sufficient.</text> </paragraph> <paragraph num="(3)"> <text>The participant, a legal guardian, the participant’s family or any significant others with the participant’s consent, shall participate with the community support specialist, to the extent practicable, in the development and regular updating of the participant’s care plan.</text> </paragraph> <paragraph num="(4)"> <text>The specific care plan shall:</text> <paragraph num="(a)"> <text>Be developed with the participant and based on the assessment;</text> </paragraph> <paragraph num="(b)"> <text>Specify the goals and actions to address the mental health, medical, social, educational, and other services needed by the participant;</text> </paragraph> <paragraph num="(c)"> <text>Include the active participation and agreement of the participant, the participant’s authorized health care decision maker, if applicable, and others designated by the participant; and</text> </paragraph> <paragraph num="(d)"> <text>Identify strategies to meet the goals and needs of the participant.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The care planning process may include, as necessary and appropriate:</text> <paragraph num="(a)"> <text>The care planning meeting, which includes the participant, and with the participant's consent, providers, family members, other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the care plan;</text> </paragraph> <paragraph num="(b)"> <text>The development and periodic updating of the written, individualized care plan based on the participant's needs, progress, and stated goals;</text> </paragraph> <paragraph num="(c)"> <text>Transitional care planning that involves contact with the participant or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and</text> </paragraph> <paragraph num="(d)"> <text>Discharge planning from mental health case management services, when appropriate and when goals for mental health case management have been achieved.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Referral and Related Activities.</text> <paragraph num="(1)"> <text>The community support specialist or associate, under the direction of a community support specialist, shall assure that the participant has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention.</text> </paragraph> <paragraph num="(2)"> <text>The community support specialist shall take the necessary action when the services identified under §D of this regulation have not occurred.</text> </paragraph> <paragraph num="(3)"> <text>The linkage process shall include:</text> <paragraph num="(a)"> <text>Community support development by contacting, with the participant’s consent, members of the participant’s support network, for example, family, friends, and neighbors, as appropriate, to mobilize assistance for the participant;</text> </paragraph> <paragraph num="(b)"> <text>Crisis intervention by referral of the participant, to services on an emergency basis when immediate intervention is necessary;</text> </paragraph> <paragraph num="(c)"> <text>Arranging for the participant's transportation to and from services;</text> </paragraph> <paragraph num="(d)"> <text>Outreach in an attempt to locate service providers which can meet the participant’s needs; and</text> </paragraph> <paragraph num="(e)"> <text>Reviewing the care plan with the participant and with the participant’s family and friends, as appropriate, so as to enable and facilitate their participation in the plan’s implementation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Monitoring and Follow-Up Activities.</text> <paragraph num="(1)"> <text>A mental health case management provider shall monitor, as frequently as necessary, the activities and contacts that are considered necessary to ensure the care plan is implemented and adequately addresses the participant’s needs, and include:</text> <paragraph num="(a)"> <text>The participant; and</text> </paragraph> <paragraph num="(b)"> <text>With proper consent:</text> <paragraph num="(i)"> <text>Family members and friends, if appropriate; and</text> </paragraph> <paragraph num="(ii)"> <text>Other service providers, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to the requirements outlined in §E of this regulation, the case management provider shall conduct, every 6 months, a reassessment to determine whether:</text> <paragraph num="(a)"> <text>Services are being furnished in accordance with the participant's care plan;</text> </paragraph> <paragraph num="(b)"> <text>Services in the care plan are adequate; and</text> </paragraph> <paragraph num="(c)"> <text>If the needs of the participant change, and if applicable, necessary adjustments are made to the care plan, including referrals for services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The mental health case management provider shall:</text> <paragraph num="(a)"> <text>Follow up any service referral to determine whether the participant made contact with the service provider that the participant was referred to; and</text> </paragraph> <paragraph num="(b)"> <text>Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The mental health case management provider may revise the care plan to reflect changing needs identified from the service monitoring.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Mental health case management may include contacts with non-participants that are directly related to identifying the needs and supports for helping the participant to access services.</text> </paragraph> <paragraph num="H."> <text>The mental health case management provider shall engage in participant advocacy, including:</text> <paragraph num="(1)"> <text>Empowering the participant to secure needed services;</text> </paragraph> <paragraph num="(2)"> <text>Taking any necessary actions to secure services on the participant's behalf; and</text> </paragraph> <paragraph num="(3)"> <text>Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Service Provision. Mental health case management services shall be provided in accordance with the following:</text> <paragraph num="(1)"> <text>For participants in Level I—General, a mental health case management provider shall provide a minimum of 1 and a maximum of 2 days of service each month;</text> </paragraph> <paragraph num="(2)"> <text>For participants in Level II—Intensive, a mental health case management provider shall provide a minimum of 2 and a maximum of 5 days of service each month; and</text> </paragraph> <paragraph num="(3)"> <text>One additional unit of service above the monthly maximum may be billed during the first month of service to a participant in order to complete the comprehensive assessment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <paragraph num="A."> <text>Mental health case management services are advisory in nature.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on a qualified recipient's option to receive mental health case management services.</text> </paragraph> <paragraph num="C."> <text>Mental health case management services do not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a participant to select from all available services for which the participant is found to be eligible; or</text> </paragraph> <paragraph num="(3)"> <text>A participant’s free choice among qualified providers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Mental health case management providers may not bill the Program for:</text> <paragraph num="(1)"> <text>The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred;</text> </paragraph> <paragraph num="(2)"> <text>Activities integral to the administration of foster care programs;</text> </paragraph> <paragraph num="(3)"> <text>Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109-171);</text> </paragraph> <paragraph num="(4)"> <text>Activities for which third parties are liable to pay; or</text> </paragraph> <paragraph num="(5)"> <text>Activities delivered as part of institutional discharge planning.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement may not be made for mental health case management services if the participant is receiving a comparable case management service under another Program authority.</text> </paragraph> <paragraph num="F."> <text>A participant's case manager may not be the participant's family member or a direct service provider for the participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Preauthorization."> <text>All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>The Program shall reimburse the provider according to the requirements in this chapter and the fees established under COMAR 10.21.25.</text> </paragraph> <paragraph num="B."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment of mental health case management services shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall submit a request for payment on the invoice form designated by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, location, and provider number; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A provider shall bill the Program for the appropriate fee or fees specified in COMAR 10.21.25.</text> </paragraph> <paragraph num="(4)"> <text>The Program may not make direct payment to recipients.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Payment shall be made:</text> <paragraph num="(1)"> <text>Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>According to the requirements of this chapter and the fees established in COMAR 10.21.25.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may reimburse providers for service delivery beyond the maximum units stated in COMAR 10.21.25 only if pre-authorized by the ASO based on a review of medical necessity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>State regulations are interpreted as those set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 20, 1992 (19:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective October 26, 1992 (19:21 Md. R. 1891)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .02B amended as an emergency provision effective June 1, 1993 (20:12 Md. R. 995); adopted permanently effective September 1, 1993 (20:17 Md. R. 1346)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 365); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 repealed and new Regulations .01—.13 adopted as an emergency provision effective August 21, 2009 (36:19 Md. R. 1433); adopted permanently effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C, E amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E adopted effective October 1, 2014 (41:19 Md. R. 1077)</annotation> </annotations> </chapter> <chapter num="46" heading="Home and Community-Based Services Waiver for Individuals with Brain Injury"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who is applying as a participant in the BI waiver.</text> </paragraph> <paragraph num="(2)"> <text>“Behavior intervention” means services designed to assist individuals who exhibit challenging behaviors in acquiring skills, gaining social acceptance, and becoming full participants in the community, consistent with behavior support services program service plans set forth in COMAR 10.22.10.</text> </paragraph> <paragraph num="(3)"> <text>“Behavioral Health Administration (BHA)” means the administration of the Department that:</text> <paragraph num="(a)"> <text>Is charged with the responsibility for providing services to individuals with behavioral health conditions as defined by Health-General Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Is designated as the State’s lead agency for service delivery to individuals with brain injury; and</text> </paragraph> <paragraph num="(c)"> <text>Manages the BI waiver, in collaboration with the Program and in accordance with a memorandum of agreement signed with the Program.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Brain injury (BI)” means an insult to the brain caused by an external or internal mechanism that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record.</text> </paragraph> <paragraph num="(5)"> <text>“CARF” means the Commission on Accreditation of Rehabilitation Facilities, a nonprofit accrediting body which promotes quality, value, and optimal outcomes of services through a consultative accreditation process that centers on enhancing the lives of individuals receiving services.</text> </paragraph> <paragraph num="(6)"> <text>Case Management.</text> <paragraph num="(a)"> <text>“Case management” means the services provided by a case manager who assists an individual in gaining access to needed medical, social, educational, and other services.</text> </paragraph> <paragraph num="(b)"> <text>“Case management” includes assessment, referral, coordination, and monitoring of the plan of care.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Case manager” means an individual who provides administrative case management services for BI waiver participants.</text> </paragraph> <paragraph num="(8)"> <text>“Day habilitation” means assistance with acquisition, retention, or improvement in self-help, socialization, and adaptive skills which takes place in a nonresidential setting, separate from the home or facility in which the individual resides, normally furnished 4 or more hours per day.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health as stated in COMAR 10.09.36.01B, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Eligible individual” means an individual who is determined to meet the qualifications for participation in the BI waiver as specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Health care professional” means an individual who is licensed and authorized by the Health Occupations Article to provide the health service for which the individual is privileged.</text> </paragraph> <paragraph num="(12)"> <text>Home and community-based services waiver for individuals with brain injury (BI waiver) means the program implemented under this chapter.</text> </paragraph> <paragraph num="(13)"> <text>“Individual support services (ISS)” means assistance with acquisition, retention, or improvement in skills related to self-help, socialization, and/or adaptive skills furnished in the participant's home or community by a provider who does not have round-the-clock responsibility for the participant's health and welfare.</text> </paragraph> <paragraph num="(14)"> <text>“Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped individuals who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07.</text> </paragraph> <paragraph num="(15)"> <text>“Nursing facility level of care” means an assessment that an individual needs the level of services provided in a nursing facility, as defined in COMAR 10.09.10.01.</text> </paragraph> <paragraph num="(16)"> <text>“Participant” means an eligible individual who is enrolled in the BI Waiver.</text> </paragraph> <paragraph num="(17)"> <text>“Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B, which exercises administrative discretion in the administration and supervision of the BI waiver and issues policies, rules, and regulations related to the BI waiver.</text> </paragraph> <paragraph num="(18)"> <text>“Provider” means an individual or an agency that:</text> <paragraph num="(a)"> <text>Is approved by the BHA and the Program as meeting the conditions for waiver participation specified in Regulations .05 and .06 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Has enrolled with the Program to provide one or more of the waiver services described under Regulations .07—.09 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Provider agreement” means a contract between the Program and a provider to provide services to waiver participants.</text> </paragraph> <paragraph num="(20)"> <text>“Residential habilitation” means assistance with acquisition, retention, or improvement in skills related to activities of daily living and the social and adaptive skills necessary to enable the individual to live in a noninstitutional setting.</text> </paragraph> <paragraph num="(21)"> <text>“Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence.</text> </paragraph> <paragraph num="(22)"> <text>“State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of Title XIX of the Social Security Act and approved by the federal Centers for Medicare and Medicaid Services, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements.</text> </paragraph> <paragraph num="(23)"> <text>“Supported employment” means activities needed to support paid work by individuals receiving waiver services, including supervision and training.</text> </paragraph> <paragraph num="(24)"> <text>“Utilization control agent” means the organization responsible for reviewing services to determine medical necessity according to professional standards and for conducting patient assessments.</text> </paragraph> <paragraph num="(25)"> <text>“Virtual supports” is an electronic method of service delivery used to maintain or improve a participant’s functional abilities, enhance interactions, support meaningful relationships, and promote their ability to live independently and meaningfully participate in their community.</text> </paragraph> <paragraph num="(26)"> <text>“Waiver plan of care” means a participant's written, individualized care plan as specified in Regulation .04 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Medical Assistance Eligibility."> <paragraph num="A."> <text>Financial eligibility for waiver participants is determined according to the provisions of this regulation and applicable sections of COMAR 10.09.24 Medical Assistance Eligibility, as cited in this section.</text> </paragraph> <paragraph num="B."> <text>Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as:</text> <paragraph num="(1)"> <text>A recipient of Supplemental Security Income (SSI);</text> </paragraph> <paragraph num="(2)"> <text>A member of a low income family with children, as described in §1931 of the Social Security Act; or</text> </paragraph> <paragraph num="(3)"> <text>A recipient eligible in another mandatory or optional categorically needy coverage group with full Medical Assistance benefits, covered in the community under the State Plan.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Optionally Categorically Needy.</text> <paragraph num="(1)"> <text>An individual is eligible for waiver services as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person.</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person.</text> </paragraph> <paragraph num="(3)"> <text>For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions specified in §C(9) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled person who is institutionalized, with the exceptions specified in §C(9) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until the penalty time expires.</text> </paragraph> <paragraph num="(6)"> <text>The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, except for the following differences in definitions:</text> <paragraph num="(a)"> <text>“Community spouse” means an individual who:</text> <paragraph num="(i)"> <text>Lives in the community outside a medical institution;</text> </paragraph> <paragraph num="(ii)"> <text>Is not determined to meet the criteria for participation in the Waiver for Individuals with Brain Injury or any other waiver under §1915(c) of Title XIX of the Social Security Act; and</text> </paragraph> <paragraph num="(iii)"> <text>Is married to an institutionalized spouse.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Continuous period of institutionalization” means:</text> <paragraph num="(i)"> <text>At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or</text> </paragraph> <paragraph num="(ii)"> <text>A determination that a spouse meets the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of Title XIX of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Institutionalized spouse” means an individual who is married to a community spouse and who is:</text> <paragraph num="(i)"> <text>An inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or</text> </paragraph> <paragraph num="(ii)"> <text>Determined to meet the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of the Social Security Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Medical Assistance eligibility shall be redetermined at least every 12 months.</text> </paragraph> <paragraph num="(8)"> <text>As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or has been determined as disabled by the Social Security Administration.</text> </paragraph> <paragraph num="(9)"> <text>All provisions of COMAR 10.09.24 which are applicable to an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions in full or in part:</text> <paragraph num="(a)"> <text>COMAR 10.09.24.04J(1)—(3);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.24.04K;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24.08G(1);</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.09.24.08H;</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.09.24.09;</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.09.24.10;</text> </paragraph> <paragraph num="(h)"> <text>COMAR 10.09.24.10-1; and</text> </paragraph> <paragraph num="(i)"> <text>COMAR 10.09.24.15A-2(2).</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not a countable resource under §C of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant:</text> <paragraph num="(a)"> <text>Child;</text> </paragraph> <paragraph num="(b)"> <text>Parent; or</text> </paragraph> <paragraph num="(c)"> <text>Sibling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Posteligibility Determination of Available Income for Optionally Categorically Needy. Participants in the waiver for individuals with brain injury are not required to pay towards their cost of care, and therefore they are not subject to a posteligibility determination of available income.</text> </paragraph> <paragraph num="E."> <text>Medically Needy. An individual is not eligible for waiver services if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>Medical Eligibility for the Waiver.</text> <paragraph num="(1)"> <text>To be medically eligible for the services covered under this chapter, an applicant shall be certified by the Program's utilization control agent to need nursing facility level of care or special hospital level of care.</text> </paragraph> <paragraph num="(2)"> <text>Every 12 months, or more frequently if determined necessary by the BHA or Program due to a significant change in the participant's condition or need, a participant's medical need for nursing facility level of care or special hospital level of care shall be reevaluated by the Program's utilization control agent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technical Eligibility for the Waiver. An applicant or participant shall be determined by the BHA, using the form for determination of eligibility for BI waiver services, to meet the waiver's technical eligibility criteria if the individual:</text> <paragraph num="(1)"> <text>Is 22 years old or older but younger than 65 years old at the time of initial admission to the waiver;</text> </paragraph> <paragraph num="(2)"> <text>Is diagnosed with brain injury as defined in Regulation .01B(4) of this chapter by a qualified physician;</text> </paragraph> <paragraph num="(3)"> <text>Was 18 years old or older when the brain injury was sustained;</text> </paragraph> <paragraph num="(4)"> <text>Is receiving:</text> <paragraph num="(a)"> <text>Care in a State psychiatric hospital that is determined to be inappropriate because the individual does not need that level of care;</text> </paragraph> <paragraph num="(b)"> <text>Brain injury community placement funded by the BHA with all-State funds;</text> </paragraph> <paragraph num="(c)"> <text>Care in a nursing facility owned and operated by the State or an out-of-State rehabilitation institution funded by the Program; or</text> </paragraph> <paragraph num="(d)"> <text>Care in a Maryland licensed special hospital for chronic disease accredited by CARF in brain injury inpatient rehabilitation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Is not enrolled in another waiver program under §1915(c) of Title XIX of the Social Security Act;</text> </paragraph> <paragraph num="(6)"> <text>Is clinically appropriate to be served in the waiver program and the waiver plan of care can serve the individual safely in the community;</text> </paragraph> <paragraph num="(7)"> <text>Chooses directly, or a legal representative chooses on the individual's behalf, to receive waiver services as an alternative to services in a nursing facility or special hospital, and documents that choice on the consent form for BI waiver services included in the approved waiver proposal;</text> </paragraph> <paragraph num="(8)"> <text>Costs the Program no more in the community than what the individual would have cost the Program in the alternative institutional placement at the nursing facility level of care or special hospital level of care, as demonstrated on the waiver plan of care and by the Program's paid claims; and</text> </paragraph> <paragraph num="(9)"> <text>Uses at least one waiver service in a 12 month period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Financial Eligibility for Medicaid. Waiver participants shall qualify for one of the categories of assistance set forth in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="D."> <text>During a 12-month waiver year, as defined in the approved waiver proposal, eligible individuals shall be enrolled in the waiver up to the maximum number of unduplicated participants established for that waiver year in the approved waiver proposal.</text> </paragraph> <paragraph num="E."> <text>Overall Waiver Eligibility.</text> <paragraph num="(1)"> <text>Using the form for determination of eligibility for BI waiver services, if an applicant is determined by the BHA:</text> <paragraph num="(a)"> <text>To meet all of the criteria specified in §§A—C of this regulation, the BHA or its authorized representatives shall sign and date the form to certify waiver eligibility and establish the effective date for waiver enrollment; or</text> </paragraph> <paragraph num="(b)"> <text>Not to meet all of the criteria specified in §§A—C of this regulation:</text> <paragraph num="(i)"> <text>The BHA or its authorized representatives shall sign and date the form to certify waiver ineligibility determination and specify in writing the reason or reasons for the determination; and</text> </paragraph> <paragraph num="(ii)"> <text>The applicant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Every 12 months, or more often if there is a significant change in the participant's condition or needs:</text> <paragraph num="(a)"> <text>The BHA and the Program's utilization control agent shall reevaluate whether the participant remains eligible for the waiver by meeting all of the criteria specified in §§A—C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The BHA or its authorized representatives shall sign and date the form for determination of eligibility for BI waiver services to certify the redetermination of waiver eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>If the BHA determines that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the:</text> <paragraph num="(i)"> <text>Participant's eligibility shall be terminated, as of the effective date established by the BHA; and</text> </paragraph> <paragraph num="(ii)"> <text>The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Cause for Termination of a Participant's Waiver Enrollment.</text> <paragraph num="(1)"> <text>A participant shall be disenrolled from the waiver, as of the date established by the Department, if the participant:</text> <paragraph num="(a)"> <text>No longer meets all of the criteria for waiver eligibility specified in §§A—C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the waiver;</text> </paragraph> <paragraph num="(c)"> <text>Is an inpatient for more than 30 days in a State psychiatric hospital, nursing facility, or intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID);</text> </paragraph> <paragraph num="(d)"> <text>Moves to another state; or</text> </paragraph> <paragraph num="(e)"> <text>Dies.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Reentering the Waiver. If a participant is discharged from the waiver, the same individual may reenter the waiver during the same waiver year, if the individual meets all eligibility requirements of the waiver.</text> </paragraph> <paragraph num="(3)"> <text>The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>The program services and supports shall:</text> <paragraph num="(1)"> <text>Maximize the level of functioning of an individual with BI through assistance and support with independent living, self care skills, and social skills in an environment which encourages the participant's ability to make decisions about the individual's life and create opportunities for choice regarding home, school or work, and community activities;</text> </paragraph> <paragraph num="(2)"> <text>Promote the use of community resources to integrate the individual into the community;</text> </paragraph> <paragraph num="(3)"> <text>Provide services that are:</text> <paragraph num="(a)"> <text>Appropriate to the age of the populations being served;</text> </paragraph> <paragraph num="(b)"> <text>Offered at times and places suitable to the individuals served; and</text> </paragraph> <paragraph num="(c)"> <text>Coordinated by BHAs administrative case manager with other medical rehabilitation, mental health, and primary care services that the individual is receiving; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Assure that staff are available, on call, 24 hours per day, 7 days per week.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Development of the Initial Waiver Plan of Care. Before the start of waiver services:</text> <paragraph num="(1)"> <text>A case manager shall meet with the participant or the participant's legal representative, in person or remotely, to develop the initial waiver plan of care;</text> </paragraph> <paragraph num="(2)"> <text>The case manager, the participant, or the participant's legal representative shall sign the waiver plan of care to indicate approval of its recommendations; and</text> </paragraph> <paragraph num="(3)"> <text>The BHAs authorized representative shall review the initial waiver plan of care and sign to indicate approval if the plan of care is determined to be:</text> <paragraph num="(a)"> <text>Sufficient to assure the participant's health and safety and meet the participant's needs in a community-based setting;</text> </paragraph> <paragraph num="(b)"> <text>Feasible according to the specifications in the waiver plan of care; and</text> </paragraph> <paragraph num="(c)"> <text>Individually cost-neutral by costing the Program no more for the participant's waiver and other Program services than the participant would have cost the Program in the alternative nursing facility or special hospital setting.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Waiver Plan of Care.</text> <paragraph num="(1)"> <text>The participant's waiver plan of care:</text> <paragraph num="(a)"> <text>Preauthorizes the specific waiver services to be provided to the participant, as covered under Regulations .07—.09 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Is documented on the waiver plan of care form included in the approved waiver proposal;</text> </paragraph> <paragraph num="(c)"> <text>Specifies for each preauthorized waiver service the following information, as appropriate:</text> <paragraph num="(i)"> <text>Description of the specific service to be provided;</text> </paragraph> <paragraph num="(ii)"> <text>Level of service;</text> </paragraph> <paragraph num="(iii)"> <text>Service start date;</text> </paragraph> <paragraph num="(iv)"> <text>Estimated duration;</text> </paragraph> <paragraph num="(v)"> <text>Approved frequency and units of service to be delivered;</text> </paragraph> <paragraph num="(vi)"> <text>Approved service delivery mode;</text> </paragraph> <paragraph num="(vii)"> <text>The provider for that service, if known; and</text> </paragraph> <paragraph num="(viii)"> <text>Estimated unit costs and monthly costs;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Describes other Program services recommended for the participant;</text> </paragraph> <paragraph num="(e)"> <text>Evaluates the participant's total costs to the Program, to ensure the participant's cost-neutrality as compared to the cost to the Program for the individual in the alternative nursing facility or special hospital setting; and</text> </paragraph> <paragraph num="(f)"> <text>Is subject to the BHAs approval.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A participant shall be given freedom of choice among all qualified and available providers for each service included in the participant's waiver plan of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Periodic Review of the Waiver Plan of Care.</text> <paragraph num="(1)"> <text>At least every 12 months or more frequently if determined necessary by the BHA:</text> <paragraph num="(a)"> <text>A case manager and the participant or the participant's legal representative shall review the waiver plan of care and revise it as necessary;</text> </paragraph> <paragraph num="(b)"> <text>The case manager and the participant or the participant's legal representative shall sign the waiver plan of care, as revised, to indicate approval of its recommendations; and</text> </paragraph> <paragraph num="(c)"> <text>The BHA or its authorized representative shall review the revised waiver plan of care, and if the plan of care is determined to meet all of the criteria specified in §C(3) of this regulation, sign to indicate approval.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Periodic reviews and updates shall take place to:</text> <paragraph num="(a)"> <text>Determine the appropriateness and adequacy of the participant's services; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that the furnished services are consistent with the services needed for the participant's disability.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conditions for Provider Participation — General."> <text>General requirements for participation in the Medical Assistance Program as a provider of BI waiver services are that the provider, with the exception of a medical day care provider, shall:</text> <paragraph num="A."> <text>Be approved by the BHA as meeting the requirements and able to provide the services specified in this chapter;</text> </paragraph> <paragraph num="B."> <text>Have a provider agreement in effect;</text> </paragraph> <paragraph num="C."> <text>Meet all the conditions for participation in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="D."> <text>Have demonstrated experience in the provision of services to individuals with BI as evidenced by:</text> <paragraph num="(1)"> <text>Having:</text> <paragraph num="(a)"> <text>A history of serving individuals with brain injury for at least the past 2 years;</text> </paragraph> <paragraph num="(b)"> <text>A program of specialized services appropriate for the needs of individuals with brain injury; and</text> </paragraph> <paragraph num="(c)"> <text>Availability of licensed healthcare professionals with experiences in the provision of services to individuals with brain injury to supervise, train, or consult with program staff regarding the needs of waiver participants; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Accreditation by CARF for the provision of brain injury services;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Verify the licenses or credentials of all agencies and individuals who render services on the provider's behalf under this chapter, and have a copy of the licenses or credentials available for inspection;</text> </paragraph> <paragraph num="F."> <text>Assure that direct care workers who render services under this chapter:</text> <paragraph num="(1)"> <text>Receive oversight from an appropriately licensed or certified health care professional; and</text> </paragraph> <paragraph num="(2)"> <text>Are determined by the provider as qualified to meet the participants' needs;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provide an annual continuing education program approved by BHA for all staff working with waiver participants on the needs of individuals with BI that may include:</text> <paragraph num="(1)"> <text>Types of brain injury;</text> </paragraph> <paragraph num="(2)"> <text>Behavioral, emotional, cognitive, and physical changes after brain injury; and</text> </paragraph> <paragraph num="(3)"> <text>Strategies for compensation and remediation of deficits caused by a brain injury;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Provide services in accordance with the requirements of Regulation .04 of this chapter and all applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="I."> <text>Agree to provide and bill BHA or its authorized representative for only those services covered under this chapter which have been preauthorized in the participant's waiver plan of care;</text> </paragraph> <paragraph num="J."> <text>Be ineligible to participate in the BI Waiver if the provider or any of its current or previous principals have overpayments that remain due and owing to the Department;</text> </paragraph> <paragraph num="K."> <text>Provide services in person, except as authorized by the Department; and</text> </paragraph> <paragraph num="L."> <text>If providing services via virtual supports, comply with the requirements established in Regulation .09-1 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Conditions for Provider Participation — Specific."> <paragraph num="A."> <text>Provider of Residential Habilitation or Rehabilitation Services. To provide the services covered under Regulation .07 of this chapter, the provider agency shall:</text> <paragraph num="(1)"> <text>Operate a community-based program of residential habilitation or rehabilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.08 for the Community Residential Services Program;</text> </paragraph> <paragraph num="(2)"> <text>Meet the participant's needs for room and board and clothing, although these services are not reimbursed by the Program; and</text> </paragraph> <paragraph num="(3)"> <text>If the facility is covered by §1616(e) of the Social Security Act, comply with applicable State standards that meet the requirements of 45 CFR Part 1937 for board and care facilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provider of Day Habilitation Services. To provide the services covered under Regulation .08 of this chapter, the provider agency shall operate a community-based program of day habilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Service Plan.</text> </paragraph> <paragraph num="C."> <text>Provider of Supported Employment Services. To provide the services covered under Regulation .09 of this chapter, the provider agency shall operate a community-based program of supported employment services that is:</text> <paragraph num="(1)"> <text>Licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Services Plan; or</text> </paragraph> <paragraph num="(2)"> <text>Approved by the Department's Office of Health Care Quality under COMAR 10.21.28, Mental Health Vocational Programs.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Provider of Individual Support Services. To provide the services covered under Regulation .09-1 of this chapter, the provider agency shall operate a community-based program of individual support services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.06 for Family and Individual Support Services.</text> </paragraph> <paragraph num="E."> <text>Provider of Medical Day Care Services.</text> <paragraph num="(1)"> <text>To provide the services covered under Regulation .09-2 of this chapter, the provider shall meet the:</text> <paragraph num="(a)"> <text>Licensure requirements as provided in COMAR 10.12.04; and</text> </paragraph> <paragraph num="(b)"> <text>Requirements of COMAR 10.09.07.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medical day care providers are not required to meet the conditions of Regulation .05 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Covered Services — Residential Habilitation Services."> <paragraph num="A."> <text>The residential habilitation services covered under this regulation shall be provided in a community-based residential facility.</text> </paragraph> <paragraph num="B."> <text>The covered services shall include:</text> <paragraph num="(1)"> <text>Habilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the socialization and adaptive skills which are necessary to reside successfully in home and community-based settings;</text> </paragraph> <paragraph num="(2)"> <text>Supervision and support, up to 24 hours a day, in a residence, based on the individual's plan of care; and</text> </paragraph> <paragraph num="(3)"> <text>Any of the following additional services which are medically necessary to prevent the participant's institutionalization and are not otherwise covered for the participant by the Program or another payer:</text> <paragraph num="(a)"> <text>Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant in the residence by a direct care worker; and</text> </paragraph> <paragraph num="(b)"> <text>Behavior intervention services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The residential habilitation services provider shall provide daily coordination of the participant's clinical treatment, rehabilitation, health, and medical services with the other providers of BI waiver services and the BI waiver case manager.</text> </paragraph> <paragraph num="D."> <text>Levels of Service.</text> <paragraph num="(1)"> <text>Services provided in a residential program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA.</text> </paragraph> <paragraph num="(2)"> <text>Level 1 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and nonawake supervision during overnight shift or an awake staff person covering more than one site during the overnight shift. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(3)"> <text>Level 2 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and awake, on-site supervision during overnight shift. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(4)"> <text>Level 3 requires a 1:1 staff to participant ratio during day and evening shifts and awake on-site supervision during overnight shift. The participant shall meet special hospital level of care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Covered Services — Day Habilitation Services."> <paragraph num="A."> <text>The day habilitation services covered under this regulation shall be provided in a nonresidential setting, separate from the home or facility in which the participant resides.</text> </paragraph> <paragraph num="B."> <text>The covered services, as defined in this chapter shall include:</text> <paragraph num="(1)"> <text>Habilitative or rehabilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the social and adaptive skills, which are necessary to reside successfully in home and community-based settings;</text> </paragraph> <paragraph num="(2)"> <text>Meals furnished as part of the program;</text> </paragraph> <paragraph num="(3)"> <text>Any of the following additional services which are provided at the provider's site, are medically necessary to prevent the participant's institutionalization, and are not otherwise covered for the participant by the Program or another payer:</text> <paragraph num="(a)"> <text>Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant by a qualified direct care worker; and</text> </paragraph> <paragraph num="(b)"> <text>Behavior intervention services; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Transportation between a participant's residence and the provider's site, or between habilitation sites if the participant receives habilitation services in more than one place.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Day habilitation services shall regularly be provided 4 or more hours per day on a regularly scheduled basis for 1 or more days per week, unless provided as an adjunct to other day activities included in the participant's waiver plan of care.</text> </paragraph> <paragraph num="D."> <text>Day habilitation services shall focus on enabling the participant to regain, attain, or maintain the participant's maximum functional level.</text> </paragraph> <paragraph num="E."> <text>The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, rehabilitation, and health and medical services.</text> </paragraph> <paragraph num="F."> <text>Levels of Service.</text> <paragraph num="(1)"> <text>Services provided in a day habilitation program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA.</text> </paragraph> <paragraph num="(2)"> <text>Level 1 requires a minimum of 1:6 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(3)"> <text>Level 2 requires a minimum of 1:4 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(4)"> <text>Level 3 requires a minimum of 1:1 staff to participant ratio. The participant shall meet special hospital level of care.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The program under this regulation does not cover recreational activities which are not related to specific treatment goals or are solely diversional.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services — Supported Employment Services."> <paragraph num="A."> <text>The supported employment services covered under this regulation shall be provided in nonresidential community settings, separate from the home or facility in which the participant resides.</text> </paragraph> <paragraph num="B."> <text>The covered services shall:</text> <paragraph num="(1)"> <text>Include a work program that includes supports necessary for the participant to achieve desired outcomes established in the waiver plan of care;</text> </paragraph> <paragraph num="(2)"> <text>Include rehabilitation activities needed to sustain the participant's job including support and training;</text> </paragraph> <paragraph num="(3)"> <text>Consist of training, skill development, and paid employment for participants:</text> <paragraph num="(a)"> <text>For whom competitive employment at or above the minimum wage is unlikely; and</text> </paragraph> <paragraph num="(b)"> <text>Who, because of disabilities, need intensive ongoing support to perform in a work setting;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be provided to help individuals obtain and maintain paid work in integrated community settings; and</text> </paragraph> <paragraph num="(5)"> <text>Include transportation or the coordination of transportation between a participant's residence and the supported employment job site.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Levels of Service.</text> <paragraph num="(1)"> <text>Services shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA.</text> </paragraph> <paragraph num="(2)"> <text>Level 1 requires that staff members provide daily contacts to the waiver participant. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(3)"> <text>Level 2 requires that staff members provide a minimum of 1 hour of direct support per day. The participant shall meet nursing facility or special hospital level of care.</text> </paragraph> <paragraph num="(4)"> <text>Level 3 requires that staff members provide continuous support for a minimum of 4 hours of service per day. The participant shall meet special hospital level of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When provided at a work site where individuals without disabilities are employed, services shall only include the adaptations, supervision, and training required by the participants as a result of their disabilities, not the supervisory activities rendered as a normal part of the business setting.</text> </paragraph> <paragraph num="E."> <text>The Program may not reimburse for the following:</text> <paragraph num="(1)"> <text>Incentive payments, subsidies, or unrelated incentive payments made to an employer to encourage or subsidize the employer's participation in a supported employment program;</text> </paragraph> <paragraph num="(2)"> <text>Payments that are passed through to participants in a supported employment program; or</text> </paragraph> <paragraph num="(3)"> <text>Payments for vocational training that is not directly related to a participant's supported employment program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09-1" heading="Covered Services — Individual Support Services."> <paragraph num="A."> <text>Individual support services, as defined in Regulation .01B of this chapter, shall be provided in a participant's own home or their community.</text> </paragraph> <paragraph num="B."> <text>The service involves the training and development of compensatory strategies and skills such that a waiver participant may learn to initiate and complete activities on their own to fully engage in their community, live independently, and compensate for cognitive and behavioral deficits related to short term memory, planning, attention, concentration, impulse control, and judgment, with the intended goal of minimizing the level of staff support the individual needs over time and preventing institutionalization.</text> </paragraph> <paragraph num="C."> <text>The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, and health and medical services.</text> </paragraph> <paragraph num="D."> <text>Individual support services shall be provided as pre-authorized by BHA and included in the waiver plan of care and provided in 15-minute units.</text> </paragraph> <paragraph num="E."> <text>Services may be provided in-person or via virtual supports as determined appropriate by the Department.</text> </paragraph> <paragraph num="F."> <text>Providers delivering services via virtual supports:</text> <paragraph num="(1)"> <text>Shall ensure the participant's rights of privacy, dignity, and respect, and freedom from coercion and restraint; and</text> </paragraph> <paragraph num="(2)"> <text>May provide direct support via virtual supports according to the following requirements and restrictions:</text> <paragraph num="(a)"> <text>Virtual supports do not isolate the participant from integration in the community or interacting with people without disabilities;</text> </paragraph> <paragraph num="(b)"> <text>The use of virtual supports is based on the participant’s preferences, has been agreed to by the participant and their team, and is outlined in the Plan of Service (POS);</text> </paragraph> <paragraph num="(c)"> <text>Virtual supports may not be used for the provider's convenience;</text> </paragraph> <paragraph num="(d)"> <text>The use of virtual supports and the service delivery method shall be documented per State requirements, policies, and guidance;</text> </paragraph> <paragraph num="(e)"> <text>Text messaging and emailing do not constitute virtual supports;</text> </paragraph> <paragraph num="(f)"> <text>The virtual supports shall comply with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and their applicable regulations to protect the privacy and security of the participant’s protected health information;</text> </paragraph> <paragraph num="(g)"> <text>ISS may not be provided entirely via virtual supports;</text> </paragraph> <paragraph num="(h)"> <text>Virtual supports shall allow flexibility of service delivery and supplement in-person direct supports as recommended and monitored by the case manager;</text> </paragraph> <paragraph num="(i)"> <text>The provider shall develop, maintain, and enforce written policies, approved by BHA, which address their procedures for ensuring:</text> <paragraph num="(i)"> <text>The participant’s rights of privacy, dignity, and respect, and freedom from coercion and restraint;</text> </paragraph> <paragraph num="(ii)"> <text>The virtual supports meet applicable information security standards; and</text> </paragraph> <paragraph num="(iii)"> <text>Their provision of virtual supports complies with applicable laws governing individuals’ right to privacy;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>The provider shall train direct support staff on their policies and advise participants and their person-centered planning teams regarding the policies that indicate how a participant’s needs, including health and safety, will be addressed safely via virtual supports;</text> </paragraph> <paragraph num="(k)"> <text>The virtual supports shall meet all federal and State requirements, policies, guidance, and regulations;</text> </paragraph> <paragraph num="(l)"> <text>The provider shall ensure that virtual supports are accessible to the participant and provide in-person trainings, prior to the initiation of virtual services, to help the participant learn to use the required technology independently; and</text> </paragraph> <paragraph num="(m)"> <text>Video cameras/monitors are not permitted in bedrooms and bathrooms.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09-2" heading="Covered Services — Medical Day Care Services."> <paragraph num="A."> <text>Covered medical day care services are those set forth in COMAR 10.09.07.</text> </paragraph> <paragraph num="B."> <text>A unit of service is a minimum of 4 hours present at the medical day care center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Conditions for Reimbursement."> <text>The Department shall reimburse for services covered under this chapter if the services are:</text> <paragraph num="A."> <text>Provided to a participant who meets the qualifications for eligibility specified in Regulations .02 and .03 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Preauthorized in the participant's waiver plan of care by the BHA, as being reasonable and medically necessary to prevent institutionalization;</text> </paragraph> <paragraph num="C."> <text>Provided by an approved provider which meets the conditions for participation in Regulations .05 and .06 of this chapter; and</text> </paragraph> <paragraph num="D."> <text>Rendered pursuant to:</text> <paragraph num="(1)"> <text>The relevant definition of covered services in Regulation .01 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>All other requirements specified in this chapter and COMAR 10.09.36; and</text> </paragraph> <paragraph num="(3)"> <text>The waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Limitations."> <paragraph num="A."> <text>Reimbursement shall be made by the Program only if all of the requirements of this chapter are met.</text> </paragraph> <paragraph num="B."> <text>Reimbursement may not be made by the Program for a waiver service furnished before:</text> <paragraph num="(1)"> <text>Enrollment of the participant in the waiver;</text> </paragraph> <paragraph num="(2)"> <text>Development of the participant's waiver plan of care; and</text> </paragraph> <paragraph num="(3)"> <text>Inclusion of the specific service in the participant's approved waiver plan of care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall reimburse for a participant not more than:</text> <paragraph num="(1)"> <text>One unit of residential habilitation services for a date of service;</text> </paragraph> <paragraph num="(2)"> <text>One unit of day habilitation per day;</text> </paragraph> <paragraph num="(3)"> <text>One unit of supported employment per day;</text> </paragraph> <paragraph num="(4)"> <text>A combined maximum of seven units of supported employment and day habilitation per week; or</text> </paragraph> <paragraph num="(5)"> <text>32 units of individual support services for a date of service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program does not cover the following:</text> <paragraph num="(1)"> <text>Room and board for the participant;</text> </paragraph> <paragraph num="(2)"> <text>Room and board for an unrelated personal caregiver who lives with the participant;</text> </paragraph> <paragraph num="(3)"> <text>Direct payments to the participant's family;</text> </paragraph> <paragraph num="(4)"> <text>Respite care for a participant residing in an out-of-home facility;</text> </paragraph> <paragraph num="(5)"> <text>Activities or supervision reimbursed by a source other than Medicaid;</text> </paragraph> <paragraph num="(6)"> <text>Payment for day habilitation on the same date of service as medical day care under COMAR 10.09.07;</text> </paragraph> <paragraph num="(7)"> <text>Payment for day habilitation on the same date of services as on-site psychiatric rehabilitation as defined in COMAR 10.21.21 and COMAR 10.21.25;</text> </paragraph> <paragraph num="(8)"> <text>Payment for residential habilitation on the same date of service as personal care under COMAR 10.09.20;</text> </paragraph> <paragraph num="(9)"> <text>Payment for residential habilitation on the same date of service as residential rehabilitation services as defined in COMAR 10.21.22;</text> </paragraph> <paragraph num="(10)"> <text>Payment for supported employment on the same date of service as mental health vocational supported employment as defined in COMAR 10.21.28;</text> </paragraph> <paragraph num="(11)"> <text>Payment for individual support services on the same day as residential habilitation services as defined in Regulation .01B of this chapter; or</text> </paragraph> <paragraph num="(12)"> <text>Payment for individual support services on the same day as family and individual support services as defined in Regulation .01B of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider, with the exception of a medical day care provider, shall submit requests for payment to BHA or its authorized representative for the services covered under this chapter, according to procedures set forth in COMAR 10.09.36.04 or otherwise established by the Department. Medical day care providers shall submit requests for payment to the Department in accordance with COMAR 10.09.07.08.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall:</text> <paragraph num="(a)"> <text>Bill the Department in accordance with the payment methodology specified in §C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Accept payment from the Department as payment in full for the services covered under this chapter and make no additional charge for the covered services to the participant or any other party; and</text> </paragraph> <paragraph num="(c)"> <text>Submit a request for payment in a manner approved by the Department, which includes the:</text> <paragraph num="(i)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(ii)"> <text>Participant's name and Medicaid number;</text> </paragraph> <paragraph num="(iii)"> <text>Provider's name, location, and Program identification number;</text> </paragraph> <paragraph num="(iv)"> <text>Type, procedure code or codes, and unit or units of covered services provided; and</text> </paragraph> <paragraph num="(v)"> <text>Amount of reimbursement requested.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall pay according to the following fee-for-service schedule:</text> <paragraph num="(a)"> <text>Residential habilitation reimbursed at:</text> <paragraph num="(i)"> <text>$305.51 per day for Level 1 effective July 1, 2024;</text> </paragraph> <paragraph num="(ii)"> <text>$404.52 per day for Level 2 effective July 1, 2024; and</text> </paragraph> <paragraph num="(iii)"> <text>$559.63 per day for Level 3 effective July 1, 2024;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Day habilitation reimbursed at:</text> <paragraph num="(i)"> <text>$78.88 per day for Level 1 effective July 1, 2024;</text> </paragraph> <paragraph num="(ii)"> <text>$137.59 per day for Level 2 effective July 1, 2024; and</text> </paragraph> <paragraph num="(iii)"> <text>$193.57 per day for Level 3 effective July 1, 2024;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Supported employment reimbursed at:</text> <paragraph num="(i)"> <text>$46.80 per day for Level 1 effective July 1, 2024;</text> </paragraph> <paragraph num="(ii)"> <text>$78.88 per day for Level 2 effective July 1, 2024; and</text> </paragraph> <paragraph num="(iii)"> <text>$193.57 per day for Level 3 effective July 1, 2024; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Individual support services (ISS): reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024; and</text> </paragraph> <paragraph num="(e)"> <text>Individual support services—virtual: reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Program shall pay for medical day care services in accordance with COMAR 10.09.07 and the participant's approved plan of care.</text> </paragraph> <paragraph num="(4)"> <text>Program rates specified in this regulation shall increase each fiscal year through FY 2026, subject to the limitations of the State budget.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07 and COMAR 10.09.07.09.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Appeal Procedures."> <paragraph num="A."> <text>Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and COMAR 10.01.04.</text> </paragraph> <paragraph num="B."> <text>Provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Interpretive Regulation."> <text>Interpretation of this regulation is subject to COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.16 adopted as an emergency provision effective July 1, 2003 (30:14 Md. R. 933); adopted permanently effective December 11, 2003 (30:24 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 25, 2010 (37:2 Md. R. 67)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C, D amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, E amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, F amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 516); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 9, 2007 (34:7 Md. R. 698); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08F amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1 adopted effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1 amended effective May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1C amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-2 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C, D amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective May 1, 2023 (50:8 Md. R. 338); March 3, 2025 (52:4 Md. R. 218); June 8, 2026 (53:11 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)</annotation> </annotations> </chapter> <chapter num="47" heading="Disproportionate Share Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.06.01 are applicable to this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Charity care” means hospital care for which the costs are not reimbursed through any patient or third party.</text> </paragraph> <paragraph num="(2)"> <text>“Charity care inpatient costs” means hospital costs that are not reimbursed through any patient or third party, reduced by the amount of gifts, restricted grants, or income from endowments. For the purposes of this chapter, third party payments include Medicaid payments for the cost of care, but do not include disproportionate share payments.</text> </paragraph> <paragraph num="(3)"> <text>“Low-income hospital costs” means the sum of a hospital's:</text> <paragraph num="(a)"> <text>Inpatient Medicaid costs;</text> </paragraph> <paragraph num="(b)"> <text>State and local government inpatient cash subsidies; and</text> </paragraph> <paragraph num="(c)"> <text>Charity care inpatient costs.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Low-income utilization rate” means, for a hospital, the sum of:</text> <paragraph num="(a)"> <text>A fraction, expressed as a percentage:</text> <paragraph num="(i)"> <text>The numerator of which is the sum, for a fiscal year, of the total revenues paid the hospital for patient services under a Medical Assistance Program, and the amount of cash subsidies for patient services received directly from State and local governments, and</text> </paragraph> <paragraph num="(ii)"> <text>The denominator of which is the total amount of revenues of the hospital for patient services, including the amount of the cash subsidies in the fiscal year; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A fraction, expressed as a percentage:</text> <paragraph num="(i)"> <text>The numerator of which is the total amount of the hospital's charges for inpatient hospital services that are attributable to charity care in a fiscal year, less the portion of any cash subsidies described in §B(4)(a)(i) of this regulation in the period reasonably attributable to inpatient hospital services, and</text> </paragraph> <paragraph num="(ii)"> <text>The denominator of which is the total amount of the hospital's charges for inpatient hospital services in the hospital in the period reasonably attributable to inpatient hospital services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Medicaid cost” means an amount equal to Medicaid payments by the Medicaid program.</text> </paragraph> <paragraph num="(6)"> <text>“Medicaid inpatient utilization rate” means a fraction, expressed as a percentage:</text> <paragraph num="(a)"> <text>The numerator of which is the hospital's number of inpatient days attributable to patients who were eligible for Medical Assistance benefits under Title XIX of the Social Security Act for a fiscal year; and</text> </paragraph> <paragraph num="(b)"> <text>The denominator of which is the total number of the hospital's inpatient days for the fiscal year in §B(6)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“State and local government inpatient cash subsidies” means the payments for hospital costs from State or local government health agencies that are not intended as reimbursement for costs directly associated with particular patients, but are provided more generally for operating costs of the institution. These subsidies do not include Medicaid payments or disproportionate share payments.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disproportionate Share Hospitals."> <paragraph num="A."> <text>A Maryland hospital is considered a disproportionate share hospital for purposes of a disproportionate share payment if the hospital's:</text> <paragraph num="(1)"> <text>Medicaid inpatient utilization rate is at least one standard deviation above the mean Medicaid inpatient utilization rate for Maryland hospitals that are Medicaid providers; or</text> </paragraph> <paragraph num="(2)"> <text>Low-income utilization rate exceeds 25 percent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To be considered a disproportionate share hospital, a hospital shall have at least two obstetricians with staff privileges who have agreed to provide obstetrical services to individuals who are entitled to Medical Assistance for services under Title XIX of the Social Security Act.</text> </paragraph> <paragraph num="C."> <text>The requirements set forth in §B of this regulation do not apply to a hospital if:</text> <paragraph num="(1)"> <text>Inpatients are predominately individuals younger than 18 years old; or</text> </paragraph> <paragraph num="(2)"> <text>The hospital did not provide nonemergency obstetric services as of December 22, 1987.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Data for §A(1) and (2) of this regulation relate to the State fiscal year occurring 2 years before the fiscal year during which payments are made.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disproportionate Share Payment."> <paragraph num="A."> <text>Free-Standing Acute General, Chronic, or Pediatric/Rehabilitation Hospitals.</text> <paragraph num="(1)"> <text>Except as set forth in §A(2) of this regulation, the disproportionate share payment for disproportionate share hospitals that are free-standing hospitals licensed as acute general, chronic, or jointly as pediatric and rehabilitation equals an amount determined in accordance with 42 CFR §412.106, but only if the hospital qualifies as a disproportionate share hospital under 42 CFR §412.106.</text> </paragraph> <paragraph num="(2)"> <text>Free-standing hospitals that are approved by the Program for reimbursement according to rates established by the HSCRC receive a bad debt allowance, which is recognized as a disproportionate share payment equal to or greater than the amount set forth in §A(1) of this regulation, and an additional payment may not be made under this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The disproportionate share payment rate relating to Program payments on or after October 1, 1992 for free-standing hospitals licensed exclusively as:</text> <paragraph num="(1)"> <text>Psychiatric with charity care inpatient costs:</text> <paragraph num="(a)"> <text>Exceeding 40 percent of total inpatient hospital costs equals the greater of the:</text> <paragraph num="(i)"> <text>Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, all multiplied by 2, and then multiplied by its inpatient Medicaid payment, or</text> </paragraph> <paragraph num="(ii)"> <text>Minimum payment required by federal law;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Less than or equal to 40 percent of total inpatient hospital costs equals the minimum payment required by federal law;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Rehabilitation with charity care inpatient costs:</text> <paragraph num="(a)"> <text>Exceeding 20 percent of total inpatient hospital costs equals the greater of the:</text> <paragraph num="(i)"> <text>Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, multiplied by its inpatient Medicaid payment, or</text> </paragraph> <paragraph num="(ii)"> <text>Minimum payment required by federal law;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Less than or equal to 20 percent of total inpatient hospital costs equals the minimum required by federal law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a hospital qualifies under both §§A(2) and B of this regulation, it is governed by §A(2) of this regulation.</text> </paragraph> <paragraph num="D."> <text>Payments according to §A or B of this regulation shall be:</text> <paragraph num="(1)"> <text>Based on data on annual low-income hospital costs, annual inpatient Medicaid costs, and data pertaining to 42 CFR §412.106 from the complete State fiscal year occurring 2 years before the fiscal year during which payments are made;</text> </paragraph> <paragraph num="(2)"> <text>Made in one or more payments covering the complete fiscal year; and</text> </paragraph> <paragraph num="(3)"> <text>Made to appropriate hospital providers that comply with all regulations set forth in COMAR 10.09.92—10.09.95.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Out-of-State hospitals determined by the host state Medicaid Program to be a disproportionate share hospital shall be paid a disproportionate share adjustment as determined by the host state Medicaid Program, with a hospital's total adjustment not to exceed 1 percent of the total Maryland Medical Assistance payments to that hospital in a fiscal year.</text> </paragraph> <paragraph num="F."> <text>Qualification Requirements.</text> <paragraph num="(1)"> <text>Except as set forth in §F(2) of this regulation, to qualify as a disproportionate share hospital, a hospital shall supply to the Program, 6 months before the start of the applicable fiscal year:</text> <paragraph num="(a)"> <text>Information necessary to determine if the hospital qualifies as a disproportionate share hospital; and</text> </paragraph> <paragraph num="(b)"> <text>Data required under §D(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For payments in fiscal year 93, the information required in this section shall be presented to the Department within 10 days of the effective date of these regulations.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A free-standing hospital licensed exclusively as psychiatric or rehabilitation for at least 2 years, that has not been a Maryland Medicaid provider for at least 2 years, shall receive a disproportionate share payment, for any year, not greater than the hospital's low-income hospital costs in the complete State fiscal year occurring 2 years before the fiscal year during which payments are made.</text> </paragraph> <paragraph num="H."> <text>If it is determined that a payment made to any hospital under this regulation exceeds the actual amount of uncompensated care and would result in reverting funds to CMS, the overpayment shall be used for another provider that received less than that provider was eligible to receive. The redistribution shall be available to all providers that are eligible for disproportionate share payments except those whose rates are set by HSCRC.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective June 1, 1992 (19:12 Md. R. 1131); adopted permanently September 1, 1992 (19:17 Md. R. 1607)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective February 17, 1993 (20:5 Md. R. 511); amended permanently effective May 24, 1993 (20:10 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective September 25, 2017 (44:19 Md. R. 896)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H adopted effective June 24, 2013 (40:12 Md. R. 1042)</annotation> </annotations> </chapter> <chapter num="48" heading="Targeted Case Management for People with Developmental Disabilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Annually” means within 365 days.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means the individual who files an application for services with the DDA.</text> </paragraph> <paragraph num="(3)"> <text>“Community Coordination Services” means provision of core services to individuals receiving ongoing DDA funding for comprehensive community services.</text> </paragraph> <paragraph num="(4)"> <text>“Community resources” means generic, local, State, or federal programs, services, benefits, and supports.</text> </paragraph> <paragraph num="(5)"> <text>“Comprehensive assessment” means an assessment of the applicant’s needs and supports to enable the DDA to determine the applicant’s eligibility for DDA funding of comprehensive community services.</text> </paragraph> <paragraph num="(6)"> <text>Comprehensive Community Services.</text> <paragraph num="(a)"> <text>“Comprehensive community services” means services funded by the DDA for residential, day, employment, or supports services.</text> </paragraph> <paragraph num="(b)"> <text>“Comprehensive community services” does not mean funding for low intensity support services or coordination of community services.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Contact” means a face-to-face meeting, phone conversation, or written correspondence related to the covered services in this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Coordination of community services” means the provision of targeted case management services that assist participants in gaining access to the full range of medical assistance services, as well as access to any additional needed generic, medical, social, habilitative, employment, recreational, housing, financial, counseling, legal, educational, and other support services.</text> </paragraph> <paragraph num="(9)"> <text>“Coordinator of community services” means an individual employed by the coordination of community services agency to assist participants in selecting, obtaining, and monitoring the most responsive and appropriate services and supports.</text> </paragraph> <paragraph num="(10)"> <text>“Coordination of community services supervisor” means an individual who is employed to oversee coordination of community services and performance of coordinators of community services.</text> </paragraph> <paragraph num="(11)"> <text>“Core services” means the following community services:</text> <paragraph num="(a)"> <text>Comprehensive assessment;</text> </paragraph> <paragraph num="(b)"> <text>Development of the person-centered plan;</text> </paragraph> <paragraph num="(c)"> <text>Referrals and related activities; and</text> </paragraph> <paragraph num="(d)"> <text>Monitoring and follow-up.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Critical incident” means a reportable event that presents an immediate and serious threat of injury, harm, impairment, or death of an individual.</text> </paragraph> <paragraph num="(13)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(14)"> <text>“Developmental Disabilities Administration (DDA)” means that agency of the Department which, under Health General Article, Title 7, Annotated Code of Maryland, is charged with the responsibility for providing services to individuals with developmental disability.</text> </paragraph> <paragraph num="(15)"> <text>“Developmental disability” has the same meaning as set forth in Health-General Article, §7-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Entity” means a facility, agency, organization, department, office, corporation, partnership, group, or individual.</text> </paragraph> <paragraph num="(17)"> <text>“Generic” means programs, services, or supports which are available to the community at large.</text> </paragraph> <paragraph num="(18)"> <text>“Goal” means measurable activity that is required to achieve progress toward an outcome.</text> </paragraph> <paragraph num="(19)"> <text>“Medicaid waiver programs” means any program under §1915(c) of the Social Security Act.</text> </paragraph> <paragraph num="(20)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(21)"> <text>“Most integrated setting” means a setting that enables a participant with a disability to interact with nondisabled individuals other than staff to the fullest extent possible.</text> </paragraph> <paragraph num="(22)"> <text>“Outcome” means tangible results of goals that reflect the desired quality of life as defined by the individual.</text> </paragraph> <paragraph num="(23)"> <text>“Participant” means an individual who meets the qualifications for participation in coordination of community services as specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(24)"> <text>Person-Centered Plan.</text> <paragraph num="(a)"> <text>“Person-centered plan” means a written plan that is developed through a planning process driven by the participant with a developmental disability to:</text> <paragraph num="(i)"> <text>Identify the participant’s goals and preferences;</text> </paragraph> <paragraph num="(ii)"> <text>Identify services to support the participant in pursuing the participant’s personally defined outcomes in the most integrated community setting;</text> </paragraph> <paragraph num="(iii)"> <text>Direct the delivery of services that reflect the participant’s personal preferences and choice; and</text> </paragraph> <paragraph num="(iv)"> <text>Identify the participant’s specific needs that must be addressed to ensure the participant’s health and welfare.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Person-centered plan” includes an individual plan as referenced in COMAR 10.22.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Person-directed supports” means service and supports that empower the participant, and the legally authorized representative on the participant’s behalf, to direct the development and implementation of a plan of supports and services that meet the participant’s personal goals.</text> </paragraph> <paragraph num="(26)"> <text>Place of Service.</text> <paragraph num="(a)"> <text>“Place of service” means the place where participants receive services.</text> </paragraph> <paragraph num="(b)"> <text>“Place of service” includes but is not limited to the participant’s home, day program, group home, alternate living arrangement, or place of employment.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(28)"> <text>“Provider” means an entity that meets the conditions for participation specified in Regulation .04 of this chapter, and is authorized by DDA to provide coordination of community services.</text> </paragraph> <paragraph num="(29)"> <text>“Reportable events” means specified incidents and complaints noted in the DDA Policy on Reportable Incidents and Investigations (PORII), as required under COMAR 10.22.02.01 and established to ensure the health, safety, and welfare of participants receiving services from DDA-funded providers.</text> </paragraph> <paragraph num="(30)"> <text>“Representative” means a person who:</text> <paragraph num="(a)"> <text>Is chosen by the participant to represent the participant’s needs and may include:</text> <paragraph num="(i)"> <text>A family representative;</text> </paragraph> <paragraph num="(ii)"> <text>An informal caregiver; or</text> </paragraph> <paragraph num="(iii)"> <text>Any other individual chosen by the participant; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is recognized by the DDA as a legally appointed guardian qualified to act on the participant’s behalf with respect to services covered under this chapter.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Service record” means all past and current health, eligibility, request for service change, service funding plan, person-centered plan, and coordination of community services documents and records.</text> </paragraph> <paragraph num="(32)"> <text>“State programs” means programs, services, or supports offered by the State.</text> </paragraph> <paragraph num="(33)"> <text>Targeted Case Management.</text> <paragraph num="(a)"> <text>“Targeted case management” means an optional service allowed under federal Medicaid rules which includes services to assist target populations of Medicaid participants to gain access to needed medical, social, educational, and other services.</text> </paragraph> <paragraph num="(b)"> <text>“Targeted case management” includes:</text> <paragraph num="(i)"> <text>Performance of a comprehensive assessment and periodic reassessment of participant needs, to determine the need for any medical, educational, social, or other services;</text> </paragraph> <paragraph num="(ii)"> <text>Provision of waiting list coordination services;</text> </paragraph> <paragraph num="(iii)"> <text>Provision of community coordination services; and</text> </paragraph> <paragraph num="(iv)"> <text>Provision of transition coordination services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Transition Coordination Services” means provision of core services to participants transitioning to the community from an institution.</text> </paragraph> <paragraph num="(35)"> <text>“Unit of service” means 15 minutes of services covered under this chapter, excluding the comprehensive assessment.</text> </paragraph> <paragraph num="(36)"> <text>“Waiting list” means participants found eligible for services in the crisis resolution, crisis prevention, or current request priority category as set forth in COMAR 10.22.12.07B.</text> </paragraph> <paragraph num="(37)"> <text>“Waiting List Coordination Services” means provision of core services to participants on the DDA waiting list.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification Requirements."> <text>The provider shall meet all applicable certification requirements as set forth in COMAR 10.22.02 unless otherwise authorized by the Developmental Disabilities Administration.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <text>To be eligible for services covered under this chapter, a participant or applicant shall:</text> <paragraph num="A."> <text>Apply to be a Medical Assistance Program participant or be Medical Assistance Program eligible; and</text> </paragraph> <paragraph num="B."> <text>Either:</text> <paragraph num="(1)"> <text>Have applied for services from the Developmental Disabilities Administration but not yet had their eligibility determined; or</text> </paragraph> <paragraph num="(2)"> <text>Be eligible for funding from the DDA as set forth in COMAR 10.22.12, and meet one of the following conditions:</text> <paragraph num="(a)"> <text>Be determined to have a developmental disability and currently on the DDA waiting list;</text> </paragraph> <paragraph num="(b)"> <text>Be receiving comprehensive community services funded by the DDA; or</text> </paragraph> <paragraph num="(c)"> <text>Be determined to have a developmental disability and in the process of transitioning to the community.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Participation — General."> <paragraph num="A."> <text>In this chapter, targeted case management services are referred to as coordination of community services.</text> </paragraph> <paragraph num="B."> <text>Providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="C."> <text>Administrative and Professional Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall:</text> <paragraph num="(1)"> <text>Be incorporated in the State in good standing with the Maryland Department of Assessments and Taxation unless operating as a local health department;</text> </paragraph> <paragraph num="(2)"> <text>Have a board of directors or local advisory board in accordance with COMAR 10.22.02;</text> </paragraph> <paragraph num="(3)"> <text>Be selected by DDA as an approved provider of coordination of community services, as evidenced by an executed DDA-approved contract;</text> </paragraph> <paragraph num="(4)"> <text>Participate in all transition and rollout processes as determined by the DDA;</text> </paragraph> <paragraph num="(5)"> <text>Maintain a standard 8-hour operational day Monday through Friday and have flexible staffing hours that include nights and weekends to accommodate the needs of participants receiving coordination of community services;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a toll-free number, unless otherwise authorized by the DDA, and an accessible communication system in accordance with the Americans with Disabilities Act of 1990;</text> </paragraph> <paragraph num="(7)"> <text>Maintain a communication system that is accessible for participants with limited English proficiency;</text> </paragraph> <paragraph num="(8)"> <text>Provide alternative communication methods to serve the needs of participants receiving coordination of community services and their family members;</text> </paragraph> <paragraph num="(9)"> <text>Have a means for participants, their families, community providers, and DDA staff to contact the coordination of community services designated staff directly in the event of an emergency and at times other than standard operating hours;</text> </paragraph> <paragraph num="(10)"> <text>Annually advise participants of their right to choose among qualified providers of services including coordination of community services;</text> </paragraph> <paragraph num="(11)"> <text>Comply with all State and federal statutes and regulations;</text> </paragraph> <paragraph num="(12)"> <text>Maintain a participant’s record for a minimum of 6 years after the record is made;</text> </paragraph> <paragraph num="(13)"> <text>Notify the DDA immediately in writing of any critical incidents that affect the health, safety, and welfare of a participant, as well as administrative and quality of care complaints as required by the DDA Policy on Reportable Incidents and Investigations; and</text> </paragraph> <paragraph num="(14)"> <text>Submit required documents and forms to the Department as requested.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Operational Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall:</text> <paragraph num="(1)"> <text>Submit a program service plan that includes:</text> <paragraph num="(a)"> <text>Scope of work; and</text> </paragraph> <paragraph num="(b)"> <text>Proposed staffing plan, including staff and staff-to-participant ratios;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complete and submit an initial and annual written quality assurance plan to the DDA which meets the requirements in COMAR 10.22.02.14 and includes the following:</text> <paragraph num="(a)"> <text>Customer service plan that includes strategies and services to meet the needs of participants, their families or caretakers, and providers; and</text> </paragraph> <paragraph num="(b)"> <text>Self-assessment, remediating, monitoring, reporting, and system improvements strategies, or other quality and compliance actions related to coordination of community services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit monthly service delivery statistical reports as defined by the Department by the 15th of each month unless otherwise directed by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Submit quarterly updates, as defined by the Department, on progress on quality assurance plans by October 15, January 15, and April 15 of each year unless otherwise directed by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Submit to the Department annually by July 15th the final quality plan summary reports unless otherwise directed by the Department;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a thorough understanding and knowledge of:</text> <paragraph num="(a)"> <text>Eligibility requirements, application procedures, and scope of services of local, State, and federal resources and programs which are applicable to participants eligible for DDA services;</text> </paragraph> <paragraph num="(b)"> <text>Medicaid, Medicaid waiver programs, and DDA eligibility requirements, application procedures, and service delivery systems; and</text> </paragraph> <paragraph num="(c)"> <text>Person-centered planning methodology and person-centered plan development and monitoring;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Coordinate services with multiple long-term service and support systems;</text> </paragraph> <paragraph num="(8)"> <text>Maximize resources to the greatest possible extent; and</text> </paragraph> <paragraph num="(9)"> <text>Obtain authorization from the DDA before providing any coordination of community services to any participant;</text> </paragraph> <paragraph num="(10)"> <text>In providing coordination of community services, meet the following requirements:</text> <paragraph num="(a)"> <text>All participants referred for coordination of community services by the DDA shall be contacted within 3 business days of receipt of referral unless otherwise authorized by the DDA;</text> </paragraph> <paragraph num="(b)"> <text>A face-to-face meeting with the referred participant shall be arranged at a time and location convenient for the referred individual during the first contact;</text> </paragraph> <paragraph num="(c)"> <text>A face-to-face meeting shall occur within 7 business days of the initial contact unless the participant’s health or schedule conflicts;</text> </paragraph> <paragraph num="(d)"> <text>If applicable, the provider shall document in the case record reasons why face-to-face meetings did not occur within the required timeframe and share the document as requested by the DDA or its designee;</text> </paragraph> <paragraph num="(e)"> <text>Authorization for specific coordination of community services shall be based on referrals from the DDA regional office; and</text> </paragraph> <paragraph num="(f)"> <text>In the event of emergencies, the participant referred for coordination of community services by the DDA shall be contacted by the coordinator of community services as circumstances require or as requested by the DDA.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Participant Record. The provider shall maintain a record on each participant which meets the Program’s requirements and which includes:</text> <paragraph num="(1)"> <text>The name of the participant;</text> </paragraph> <paragraph num="(2)"> <text>The dates of the coordination of community services;</text> </paragraph> <paragraph num="(3)"> <text>The name of the provider agency and the name of agency employee providing the coordination of community service;</text> </paragraph> <paragraph num="(4)"> <text>The name, address, and telephone number of the individual or individuals to be contacted in case of emergency;</text> </paragraph> <paragraph num="(5)"> <text>A completed person-centered plan;</text> </paragraph> <paragraph num="(6)"> <text>The comprehensive assessment as applicable;</text> </paragraph> <paragraph num="(7)"> <text>Documentation that the coordinator of community services provided the participant with a choice among qualified providers of services, including coordination of community services;</text> </paragraph> <paragraph num="(8)"> <text>Documentation that indicates whether the participant has declined services in the person-centered plan and the reason for declining;</text> </paragraph> <paragraph num="(9)"> <text>Documentation that includes:</text> <paragraph num="(a)"> <text>A schedule for obtaining needed services;</text> </paragraph> <paragraph num="(b)"> <text>A timeline for re-evaluation of the person-centered plan not less than annually; and</text> </paragraph> <paragraph num="(c)"> <text>The name and position of the individual responsible for completing tasks related to the person-centered plan;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Status of progress on participant-intended outcomes identified in the person-centered plan;</text> </paragraph> <paragraph num="(11)"> <text>Documentation of coordination with other service systems, including:</text> <paragraph num="(a)"> <text>Demonstrated need for other services systems; and</text> </paragraph> <paragraph num="(b)"> <text>Dates of occurrences of coordination with other service systems; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Documentation for each contact made by the coordinator of community services including:</text> <paragraph num="(a)"> <text>Date and subject of contact;</text> </paragraph> <paragraph num="(b)"> <text>Individual contacted;</text> </paragraph> <paragraph num="(c)"> <text>Individual making the contact;</text> </paragraph> <paragraph num="(d)"> <text>Contact method;</text> </paragraph> <paragraph num="(e)"> <text>Nature and extent of coordination of community services provided;</text> </paragraph> <paragraph num="(f)"> <text>Number of unit or units of service provided;</text> </paragraph> <paragraph num="(g)"> <text>Place of service; and</text> </paragraph> <paragraph num="(h)"> <text>Services referred.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Technology Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall:</text> <paragraph num="(1)"> <text>Utilize an electronic information system which, at a minimum:</text> <paragraph num="(a)"> <text>Maintains confidential individual case and billing records;</text> </paragraph> <paragraph num="(b)"> <text>Provides documentation of coordination of community services and number of units provided for participants receiving services;</text> </paragraph> <paragraph num="(c)"> <text>Maintain a permanent history log of all entries made to the record; and</text> </paragraph> <paragraph num="(d)"> <text>Adheres to applicable State and federal laws; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Adhere to the following information technology requirements:</text> <paragraph num="(a)"> <text>Use the DDA’s designated data system unless another data system is approved annually by the DDA;</text> </paragraph> <paragraph num="(b)"> <text>Ensure that all management information systems:</text> <paragraph num="(i)"> <text>Are secure from improper use, alteration, or disclosure;</text> </paragraph> <paragraph num="(ii)"> <text>Utilize industry best practices for secure connection to management information systems;</text> </paragraph> <paragraph num="(iii)"> <text>Secure network connections with logon only from a secured location;</text> </paragraph> <paragraph num="(iv)"> <text>Prohibit users from sharing user accounts;</text> </paragraph> <paragraph num="(v)"> <text>Limit access to the system and related information based on job function; and</text> </paragraph> <paragraph num="(vi)"> <text>Adhere to DDA information technology data security policies, standards, and procedures when using DDA managed systems;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Report security violations and actual or attempted security breaches affecting the managed systems with participant information immediately but not later than 48 hours after the violation or breach;</text> </paragraph> <paragraph num="(d)"> <text>Maintain and update as necessary all electronic data systems to be compatible with those of the State and, if required, work with DDA to develop a system for developing protocols for data sharing and read-only access for the DDA and its designees; and</text> </paragraph> <paragraph num="(e)"> <text>Obtain written approval from the DDA before posting on any public website information that describes DDA services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Billing. To receive payment for services covered under this chapter, the provider shall:</text> <paragraph num="(1)"> <text>Comply with Department’s requirements for submitting, processing, and reconciling claims for payment for services rendered under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Be in good standing with the Maryland Department of Assessments and Taxation, and with its equivalent in every state in which the applicant provides services;</text> </paragraph> <paragraph num="(3)"> <text>Permit the DDA or the Department or its agent, or any State or federal entity operating within its statutory authority to conduct audits and provide immediate access to all records upon request; and</text> </paragraph> <paragraph num="(4)"> <text>Comply with audit requirements.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Freedom of Choice. The provider shall place no restrictions on the participant’s freedom of choice among:</text> <paragraph num="(1)"> <text>Providers of coordination of community services;</text> </paragraph> <paragraph num="(2)"> <text>Providers of community-based services for which the participant qualifies; and</text> </paragraph> <paragraph num="(3)"> <text>Service delivery models available under the DDA’s Medicaid waiver programs.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Transfer of Service Records. For participants changing from one DDA-authorized coordination of community services provider to a different DDA-authorized coordination of community services provider, the outgoing provider shall:</text> <paragraph num="(1)"> <text>Transfer the service record to the new provider; and</text> </paragraph> <paragraph num="(2)"> <text>Share with the new provider the participant’s demographic information and the most recent person-centered plan within 5 business days of notification of transfer for the continued coordination of services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Provision of Services. The provider may not exercise the agency’s authority to authorize or deny DDA or other State funded services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conditions for Participation — Staff Requirements."> <paragraph num="A."> <text>Staff Capability Requirements. The provider shall:</text> <paragraph num="(1)"> <text>Employ only personnel who are appropriately qualified as set forth in this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Maintain sufficient staff required to meet the needs of the participants whom the provider serves;</text> </paragraph> <paragraph num="(3)"> <text>Have administrative and supervisory staff to ensure the quality of coordination of community services provided by the provider;</text> </paragraph> <paragraph num="(4)"> <text>Have a management capability team, each member of which has at least 3 years of experience providing coordination of community services or management experience in human services; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain personnel files for each employee which includes documentation of staff qualifications as set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Training Requirements.</text> <paragraph num="(1)"> <text>All DDA-certified coordination of community services providers shall ensure through appropriate documentation that coordination of community services staff, supervisors, and quality assurance staff receive training, as required by DDA.</text> </paragraph> <paragraph num="(2)"> <text>All coordination of community services staff shall receive training on procedures, protocols, processes, and regulations as required by the DDA.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Coordination of community services staff shall:</text> <paragraph num="(1)"> <text>Receive required training as specified in COMAR 10.22, unless otherwise directed by the DDA, which shall be documented and made available upon request;</text> </paragraph> <paragraph num="(2)"> <text>Comply with all State and federal statutes, regulations, and policies; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate competency-based skills and working knowledge in the following areas:</text> <paragraph num="(a)"> <text>Negotiation and conflict management;</text> </paragraph> <paragraph num="(b)"> <text>Crisis management;</text> </paragraph> <paragraph num="(c)"> <text>Community resources including generic programs, local programs, State programs, and federal programs and resources;</text> </paragraph> <paragraph num="(d)"> <text>Determining the most integrated setting appropriate to meet the participant’s needs;</text> </paragraph> <paragraph num="(e)"> <text>Coordinating and facilitating planning meetings;</text> </paragraph> <paragraph num="(f)"> <text>Assessing, planning, and coordinating services;</text> </paragraph> <paragraph num="(g)"> <text>Assisting participants in gaining access to services and supports;</text> </paragraph> <paragraph num="(h)"> <text>Monitoring the provision of services to participants;</text> </paragraph> <paragraph num="(i)"> <text>Allied service delivery systems, including Medicaid, mental health, substance abuse, social services, juvenile justice, vocational rehabilitation, and corrections; and</text> </paragraph> <paragraph num="(j)"> <text>Regulations governing services for participants with developmental disabilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Coordination of Community Services Supervisor. The coordination of community services supervisor shall:</text> <paragraph num="(1)"> <text>Except as stated in §F of this regulation, meet one or more of the following education requirements:</text> <paragraph num="(a)"> <text>An advanced degree from an accredited education program in human services and 1 year of experience as set forth in §C of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>A bachelor’s degree from an accredited education program in human services with 3 years experience as set forth in §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Demonstrate experience in one or more of the following:</text> <paragraph num="(a)"> <text>Coordinating services for participants in Medicaid or waiver programs; or</text> </paragraph> <paragraph num="(b)"> <text>Coordinating services for participants with intellectual or developmental disabilities;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Demonstrate experience in all of the following:</text> <paragraph num="(a)"> <text>Social services intake and referral services;</text> </paragraph> <paragraph num="(b)"> <text>Data collection, analysis, and reporting;</text> </paragraph> <paragraph num="(c)"> <text>Staff supervision; and</text> </paragraph> <paragraph num="(d)"> <text>Management or leadership;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Supervise the work of coordinators of community services; and</text> </paragraph> <paragraph num="(5)"> <text>Monitor the quality of services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Coordinator of Community Services. The coordinator of community services shall:</text> <paragraph num="(1)"> <text>Except as stated in §F of this regulation, have:</text> <paragraph num="(a)"> <text>A bachelor’s degree from an accredited education program in a human services field;</text> </paragraph> <paragraph num="(b)"> <text>An associate’s degree with 2 years’ experience in a human services field; or</text> </paragraph> <paragraph num="(c)"> <text>7 years’ experience in a human services field;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Use all communication methodologies, strategies, devices, and techniques necessary, including sign language, assistive technology, or language interpreter services, to facilitate the involvement of the participant in the assessment, development, and monitoring of services and supports;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that each participant receives a person-centered plan that is designed to meet the individual’s needs in the most cost-effective manner; and</text> </paragraph> <paragraph num="(4)"> <text>Annually advise participants of their right to choose among qualified providers of services including coordination of community services.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Education and Experience Waiver.</text> <paragraph num="(1)"> <text>Coordination of Community Services Supervisor. Education and experience requirements may be waived if an individual has been employed as a coordination of community services supervisor for at least 1 year as of January 1, 2014.</text> </paragraph> <paragraph num="(2)"> <text>Coordinator of Community Services. Education and experience requirements may be waived if an individual has been employed as a coordinator of community services for at least 1 year as of January 1, 2014.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An individual is ineligible for employment by a coordination of community services provider, agency, or entity in Maryland if the individual:</text> <paragraph num="(1)"> <text>Is simultaneously employed by any MDH-licensed or MDH-certified provider agency;</text> </paragraph> <paragraph num="(2)"> <text>Is on the Maryland Medicaid exclusion list;</text> </paragraph> <paragraph num="(3)"> <text>Is on the federal List of Excluded Individuals/Entities (LEIE);</text> </paragraph> <paragraph num="(4)"> <text>Is on the federal list of excluded parties as maintained by the System of Award Management (SAM.GOV);</text> </paragraph> <paragraph num="(5)"> <text>Has been convicted of a crime of violence in violation of Criminal Law Article, §14-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Violates or has violated Health-General Article, §7-1102, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(7)"> <text>Has been found guilty or been given Probation Before Judgment for a crime which would indicate behavior potentially harmful to individuals receiving services, as documented either through a criminal history records check or a criminal background check, pursuant to:</text> <paragraph num="(a)"> <text>Health-General Article, §19-1902, et seq., Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 12.15.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>Only core services shall be authorized for payment by DDA as covered coordination of community services.</text> </paragraph> <paragraph num="B."> <text>The coordinator of community services shall provide the core services listed in this regulation to every participant assigned to the coordinator.</text> </paragraph> <paragraph num="C."> <text>Comprehensive Assessment. Coordination of community services shall include a comprehensive assessment of the participant’s needs and supports to determine eligibility, in accordance with COMAR 10.22.12. The assessment shall be completed within 45 days after referral by the DDA and include:</text> <paragraph num="(1)"> <text>A review of relevant medical and other records with the applicant or legal representative’s written consent;</text> </paragraph> <paragraph num="(2)"> <text>A review of current providers of medical, social, or other support services, as appropriate;</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise authorized by the DDA, a face-to-face assessment of the participant, preferably at the participant’s residence, to review:</text> <paragraph num="(a)"> <text>Medical, developmental, and mental history, including current medications;</text> </paragraph> <paragraph num="(b)"> <text>Nutritional status;</text> </paragraph> <paragraph num="(c)"> <text>Emotional and behavioral status;</text> </paragraph> <paragraph num="(d)"> <text>Health care coverage;</text> </paragraph> <paragraph num="(e)"> <text>Living situation;</text> </paragraph> <paragraph num="(f)"> <text>Personal support systems;</text> </paragraph> <paragraph num="(g)"> <text>Participant goals and preferences;</text> </paragraph> <paragraph num="(h)"> <text>Environmental, social, and functional status;</text> </paragraph> <paragraph num="(i)"> <text>Educational history;</text> </paragraph> <paragraph num="(j)"> <text>Employment and income status;</text> </paragraph> <paragraph num="(k)"> <text>Health education;</text> </paragraph> <paragraph num="(l)"> <text>Social support;</text> </paragraph> <paragraph num="(m)"> <text>The most integrated setting appropriate to meet the participant’s needs; and</text> </paragraph> <paragraph num="(n)"> <text>Any additional service needs;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Assistance with information-gathering such as obtaining professional evaluations and assessments necessary to document and recommend eligibility and priority for services; and</text> </paragraph> <paragraph num="(5)"> <text>A completed assessment form as required by the DDA.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Person-Centered Plan.</text> <paragraph num="(1)"> <text>The coordinator of community services shall facilitate the person-centered plan that is designed to meet the participant’s needs, preferences, goals, and outcomes in the most integrated setting and in the most cost effective manner.</text> </paragraph> <paragraph num="(2)"> <text>The person-centered plan shall:</text> <paragraph num="(a)"> <text>Be participant-centered, outcome-oriented, and person directed, as selected by participant;</text> </paragraph> <paragraph num="(b)"> <text>Comply with the requirements set forth in COMAR 10.22.05;</text> </paragraph> <paragraph num="(c)"> <text>Establish a plan for emergencies;</text> </paragraph> <paragraph num="(d)"> <text>Be completed within 30 business days after initial contact with the participant, and, if necessary, updated or modified within 30 business days after service initiation;</text> </paragraph> <paragraph num="(e)"> <text>Be developed and written in collaboration with the participant and his or her identified representatives as appropriate;</text> </paragraph> <paragraph num="(f)"> <text>Provide services in the most integrated setting;</text> </paragraph> <paragraph num="(g)"> <text>Identify services needed to accomplish intended outcomes and preferences;</text> </paragraph> <paragraph num="(h)"> <text>Address risks and needs identified in the comprehensive assessment; and</text> </paragraph> <paragraph num="(i)"> <text>Be updated or revised:</text> <paragraph num="(i)"> <text>As the conditions or circumstances of the participant change or as requested by the participant; and</text> </paragraph> <paragraph num="(ii)"> <text>Within 365 days of the initial person-centered plan or annually.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Specific requirements for the person-centered plan developed for participants receiving transition coordination services are that the person-centered plan shall:</text> <paragraph num="(a)"> <text>Address challenges related to transitioning;</text> </paragraph> <paragraph num="(b)"> <text>Focus on transition from the institutional setting to the community;</text> </paragraph> <paragraph num="(c)"> <text>Identify services and supports that may be available;</text> </paragraph> <paragraph num="(d)"> <text>Be outcome-oriented; and</text> </paragraph> <paragraph num="(e)"> <text>Include the provision of services and supports.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Referral and Related Activities.</text> <paragraph num="(1)"> <text>At the time of the initial meeting and any follow-up contacts, coordinators of community services shall provide information, make referrals, and assist participants with applications for services provided by:</text> <paragraph num="(a)"> <text>Community organizations;</text> </paragraph> <paragraph num="(b)"> <text>State programs; and</text> </paragraph> <paragraph num="(c)"> <text>Federal programs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Referral and related activities may include:</text> <paragraph num="(a)"> <text>Assisting the participant with the completion of applications for services and programs;</text> </paragraph> <paragraph num="(b)"> <text>Providing the participant with contact or other information for services provided by self-advocacy groups, recreation organizations, or social groups;</text> </paragraph> <paragraph num="(c)"> <text>Assisting the participant with transitioning to new services, providers, or supports;</text> </paragraph> <paragraph num="(d)"> <text>Assisting the participant with referrals, as needed; and</text> </paragraph> <paragraph num="(e)"> <text>Providing education to participants and their families concerning:</text> <paragraph num="(i)"> <text>The range of most integrated setting service and support options that may be appropriate to meet the participant’s needs and preferences;</text> </paragraph> <paragraph num="(ii)"> <text>How to access services; and</text> </paragraph> <paragraph num="(iii)"> <text>How to coordinate and advocate for services.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Monitoring and Follow-Up.</text> <paragraph num="(1)"> <text>The coordinator of community services shall provide monitoring and follow-up activities, which shall include:</text> <paragraph num="(a)"> <text>Assessment of:</text> <paragraph num="(i)"> <text>Services being rendered as specified in the person-centered plan;</text> </paragraph> <paragraph num="(ii)"> <text>The participant’s current circumstances;</text> </paragraph> <paragraph num="(iii)"> <text>Progress toward goals and intended outcomes;</text> </paragraph> <paragraph num="(iv)"> <text>The participant’s referral status; and</text> </paragraph> <paragraph num="(v)"> <text>The participant’s needs and supports to maintain eligibility for Medicaid, Medicaid waiver programs, DDA services, and any other relevant benefits or services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Identification of new medical, health services, or other needs;</text> </paragraph> <paragraph num="(c)"> <text>Recommendation of new DDA priority category as the conditions or circumstances of the participant changes, or as requested by the DDA;</text> </paragraph> <paragraph num="(d)"> <text>Requests for service change and modifications of the person-centered plan as necessary to meet health and safety needs, preferences, and goals;</text> </paragraph> <paragraph num="(e)"> <text>Identification of new support or resource options;</text> </paragraph> <paragraph num="(f)"> <text>Review and, if necessary, revision of the plan for emergencies;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring of any and all reportable incidents as defined in DDA’s reportable incident policy; and</text> </paragraph> <paragraph num="(h)"> <text>Application or re-application for necessary programs or services to prevent or remedy a gap in eligibility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Frequency of Monitoring and Follow-up Contact.</text> <paragraph num="(a)"> <text>For participants receiving waiting list coordination services, monitoring and follow-up contact activities shall meet the following requirements:</text> <paragraph num="(i)"> <text>For participants who meet the criteria for the crisis resolution priority category as set forth in COMAR 10.22.12.07, minimum monthly face-to-face contacts shall be made for the first 90 days, after which face-to-face contacts will be made quarterly;</text> </paragraph> <paragraph num="(ii)"> <text>For participants who meet the criteria for the crisis prevention priority category as set forth in COMAR 10.22.12.07, minimum quarterly face-to-face contacts shall be made; and</text> </paragraph> <paragraph num="(iii)"> <text>For participants who meet the criteria for the current request priority category as set forth in COMAR 10.22.12.07, minimum annual face-to-face contacts shall be made.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Participants on the DDA waiting list shall be monitored in accordance with §F(2)(a) of this regulation unless:</text> <paragraph num="(i)"> <text>The participant’s priority category changes; or</text> </paragraph> <paragraph num="(ii)"> <text>Additional units are authorized by DDA.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For participants receiving community coordination services, monitoring and follow-up activities shall be performed:</text> <paragraph num="(i)"> <text>On a minimum quarterly basis;</text> </paragraph> <paragraph num="(ii)"> <text>Face to face with the participant;</text> </paragraph> <paragraph num="(iii)"> <text>In different services delivery settings; and</text> </paragraph> <paragraph num="(iv)"> <text>At least one time in each service delivery setting.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For participants receiving transition coordination services, monitoring and follow-up activities shall be performed face-to-face at least once a month for the first 90 calendar days, after which face-to-face contacts shall be made quarterly.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Records of monitoring activities shall:</text> <paragraph num="(a)"> <text>Be completed in a format approved by the DDA;</text> </paragraph> <paragraph num="(b)"> <text>Include descriptions of the participant’s current circumstances, progress toward goals, intended outcomes, preferences, and referral status;</text> </paragraph> <paragraph num="(c)"> <text>Document new support and resource options for intake and referral;</text> </paragraph> <paragraph num="(d)"> <text>Be submitted using the electronic system provided by the Department; and</text> </paragraph> <paragraph num="(e)"> <text>Document all reportable events as set in the DDA’s policy on reportable incidents and investigations.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <paragraph num="A."> <text>Restrictions may not be placed on a participant’s option to receive coordination of community services.</text> </paragraph> <paragraph num="B."> <text>Coordination of community services provided under this chapter does not restrict or otherwise affect eligibility for Title XIX benefits or other available benefits or programs.</text> </paragraph> <paragraph num="C."> <text>Coordination of community services may not be:</text> <paragraph num="(1)"> <text>Provided as an integral and inseparable part of another covered Program service;</text> </paragraph> <paragraph num="(2)"> <text>Provided as an administrative function;</text> </paragraph> <paragraph num="(3)"> <text>Rendered in connection with the implementation of another service authorized under §1915(b) or 1915(c) of the Social Security Act; or</text> </paragraph> <paragraph num="(4)"> <text>Provided as a substitute or in duplication of another service or support.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Unless otherwise approved by the Department, reimbursement may not be made for coordination of community services if the participant is receiving comparable case management services under any other State program.</text> </paragraph> <paragraph num="E."> <text>A participant’s coordination of community services provider may not also provide DDA-funded direct services, including meaningful day, support, and residential services for the participant.</text> </paragraph> <paragraph num="F."> <text>Service Exclusions.</text> <paragraph num="(1)"> <text>Unless an individual is transitioning into the community, coordination of community services may not be provided to:</text> <paragraph num="(a)"> <text>Individuals between the ages of 22 and 64 who are served in institutions for mental disease; or</text> </paragraph> <paragraph num="(b)"> <text>Inmates or residents of public institutions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services of more than 180 consecutive days of a covered stay in a medical institution will not be reimbursed unless an individual is transitioning from another Medicaid program into a DDA waiver program as authorized by the DDA.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant is ineligible to be a provider if, within the preceding 10 years, the entity, its owner, or any member of its board of directors has had a provider license or certification revoked or suspended for more than 30 days, pursuant to Maryland or another state’s regulations, or has been found by a court of law to have committed fraud, abuse, intentional or negligent tort, or a criminal act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>Requests for payment for the services covered under this chapter shall be submitted by a provider according to procedures set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="(2)"> <text>Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Payment Rates.</text> <paragraph num="(1)"> <text>The Department shall publish a fee schedule for services covered under this chapter, which shall be publicly available and updated at least annually or upon any changes made by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Department's rates set forth in its fee schedule will apply to services covered under this chapter that are provided under either the traditional services delivery model or the self-directed services delivery model.</text> </paragraph> <paragraph num="(3)"> <text>The Program's rates for covered services under this chapter shall increase on July 1 of each year, subject to the limitations of the State budget.</text> </paragraph> <paragraph num="(4)"> <text>Providers shall be reimbursed within 45 business days of approved invoice for services rendered based on the rates set forth in §C(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>For a comprehensive assessment, providers shall be reimbursed $450 per assessment.</text> </paragraph> <paragraph num="(6)"> <text>For all other services rendered to Maryland Medicaid participants residing in counties other than those listed in §B(7) of this regulation, providers shall be reimbursed:</text> <paragraph num="(a)"> <text>For dates of service January 1, 2023 through June 30, 2023, $24.56 per unit;</text> </paragraph> <paragraph num="(b)"> <text>For dates of service July 1, 2023 through December 31, 2023, $25.54 per unit;</text> </paragraph> <paragraph num="(c)"> <text>For dates of service January 1, 2024 through June 30, 2024, $27.50 per unit; and</text> </paragraph> <paragraph num="(d)"> <text>For dates of service July 1, 2024 through June 30, 2025, $28.33 per unit.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Providers rendering services to Maryland Medicaid participants residing in Calvert, Charles, Frederick, Montgomery, and Prince George’s counties shall be reimbursed:</text> <paragraph num="(a)"> <text>For dates of service January 1, 2023 through June 30, 2023, $25.86 per unit;</text> </paragraph> <paragraph num="(b)"> <text>For dates of service July 1, 2023 through December 31, 2023, $26.89 per unit;</text> </paragraph> <paragraph num="(c)"> <text>For dates of service January 1, 2024 through June 30, 2024, $28.96 per unit; and</text> </paragraph> <paragraph num="(d)"> <text>For dates of service July 1, 2024 through June 30, 2025, $29.83 per unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Changes in Rates.</text> <paragraph num="(1)"> <text>The rates are subject to the limitations of the State budget.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise authorized, the rates may be changed on July 1 of each year beginning July 1, 2015, based on legislative action, and subject to limitations of the State budget.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Payment Limitations.</text> <paragraph num="(1)"> <text>Payment shall be made only to one provider for covered services rendered to a participant on a particular date of service.</text> </paragraph> <paragraph num="(2)"> <text>Payment for the services covered under this chapter:</text> <paragraph num="(a)"> <text>Shall be considered as payment in full; and</text> </paragraph> <paragraph num="(b)"> <text>May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a comprehensive assessment, only one assessment may be reimbursed per participant, unless otherwise authorized by DDA.</text> </paragraph> <paragraph num="(4)"> <text>Ongoing coordination of community services shall be billed on a scheduled determined by the Department.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Units of Services and Limitations.</text> <paragraph num="(1)"> <text>All coordination of community services other than the initial comprehensive assessment shall be billed to DDA in units of service.</text> </paragraph> <paragraph num="(2)"> <text>DDA shall provide payment for only those coordination of community services that were authorized by DDA before the provision of the service.</text> </paragraph> <paragraph num="(3)"> <text>Each fiscal year, the coordinator of community services shall complete the core services for each participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08 and 10.22.03.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Appeal Procedures."> <paragraph num="A."> <text>Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09.</text> </paragraph> <paragraph num="B."> <text>Appeal procedures for participants shall be as set forth in COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.18 adopted as an emergency provision effective June 23, 1992 (19:14 Md. R. 1276); adopted permanently effective October 12, 1992 (19:20 Md. R. 1815)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 and .06 amended and Regulation .12 repealed as an emergency provision effective December 9, 1994 (21:26 Md. R. 2183); adopted permanently effective March 27, 1995 (22:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.18 under Case Management for Individuals with Developmental Disability repealed and new Regulations .01—.12 under Targeted Case Management for People with Intellectual and Developmental Disabilities adopted effective July 8, 2013 (40:13 Md. R. 1074)</annotation> <annotation type="History" subtype="Administrative History">Chapter name, Targeted Case Management for People with Intellectual and Developmental Disabilities amended to be Targeted Case Management for People with Developmental Disabilities effective June 8, 2015 (42:11 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 8, 2015 (42:11 Md. R. 723); June 20, 2016 (43:12 Md. R. 666); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective August 14, 2017 (44:16 Md. R. 809); February 12, 2018 (45:3 Md. R. 156); December 31, 2018 (45:26 Md. R. 1243); December 30, 2019 (46:26 Md. R. 1164); August 21, 2023 (50:16 Md. R. 276); September 16, 2024 (51:18 Md. R. 809); November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 8, 2015 (42:11 Md. R. 723)</annotation> </annotations> </chapter> <chapter num="49" heading="Telehealth Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to covered services delivered via synchronous telehealth and eligible for reimbursement by the Maryland Medicaid Program.</text> </paragraph> <paragraph num="B."> <text>The purpose of providing medically necessary services via telehealth is to improve:</text> <paragraph num="(1)"> <text>Access to services, thus reducing preventable hospitalizations and barriers to health care access;</text> </paragraph> <paragraph num="(2)"> <text>Access to outpatient and inpatient subspecialty services, thus improving diagnostic clarification, treatment recommendations, and planning for the individual;</text> </paragraph> <paragraph num="(3)"> <text>Health outcomes through timely disease detection and treatment options; and</text> </paragraph> <paragraph num="(4)"> <text>Capacity and choice for ongoing treatment in underserved areas of the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative services organization (ASO)” means an entity that manages the Public Behavioral Health System on behalf of the Department.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(3)"> <text>“Distant site” means a site at which the licensed, certified, or otherwise authorized distant site provider is located at the time the service is provided via technology-assisted communication.</text> </paragraph> <paragraph num="(4)"> <text>“Distant site provider” means the licensed, certified, or otherwise authorized provider at the distant site who provides medically necessary services via telehealth to the patient.</text> </paragraph> <paragraph num="(5)"> <text>“GT modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio and video telecommunications system.</text> </paragraph> <paragraph num="(6)"> <text>“Medically necessary" means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Originating site means the location of an eligible Medicaid participant at the time the service being furnished via technology-assisted communication occurs.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(9)"> <text>“Provider” means:</text> <paragraph num="(a)"> <text>An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Medical Assistance participants and who, through appropriate agreement with the Department, has been identified as a Maryland Medical Assistance Provider by the issuance of an individual account number;</text> </paragraph> <paragraph num="(b)"> <text>An agent, employee, or related party of a person identified in §B(12)(a) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>An individual or any other person with an ownership interest in a person identified in §B(12)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Store and Forward Technology.</text> <paragraph num="(a)"> <text>“Store and forward technology" means the transmission of medical images or other media captured by the originating site provider and sent electronically to a distant site provider, who does not physically interact with the patient located at the originating site.</text> </paragraph> <paragraph num="(b)"> <text>“Store and forward technology” does not mean dermatology, ophthalmology, or radiology services according to COMAR 10.09.02.07.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Technology-assisted communication” means multimedia communication equipment permitting two-way real-time interactive communication between a patient at an originating site and a distant site provider at a distant site.</text> </paragraph> <paragraph num="(12)"> <text>“Telehealth” means the synchronous delivery of medically necessary services to a patient at an originating site by distant site provider, through the use of technology-assisted communication.</text> </paragraph> <paragraph num="(13)"> <text>“Telehealth Program” means the program by which medically necessary services are authorized to be delivered via technology-assisted communication between originating and distant site providers.</text> </paragraph> <paragraph num="(14)"> <text>“UB modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio-only telecommunications system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Services."> <text>Under the Telehealth Program, the Department shall cover:</text> <paragraph num="A."> <text>Medically necessary services covered by the Maryland Medical Assistance Program rendered via telehealth that shall be:</text> <paragraph num="(1)"> <text>Distinct from services provided in person;</text> </paragraph> <paragraph num="(2)"> <text>Able to be delivered using technology-assisted communication; and</text> </paragraph> <paragraph num="(3)"> <text>Clinically appropriate to be delivered via telehealth;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services provided via telehealth to the same extent and standard of care as services provided in person;</text> </paragraph> <paragraph num="C."> <text>As determined by the provider’s licensure or credentialing board, services performed via telehealth within the scope of a provider’s practice; and</text> </paragraph> <paragraph num="D."> <text>Services permitted to be provided via telehealth as set forth in the COMAR chapter defining the covered service being rendered..</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Provider Conditions for Participation."> <paragraph num="A."> <text>To render or bill for services delivered via telehealth, the provider shall meet the requirements as set forth in:</text> <paragraph num="(1)"> <text>COMAR 10.09.36.02;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(3)"> <text>The COMAR chapter defining the covered service being rendered.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall obtain the participant’s consent to services via telehealth, unless there is an emergency that prevents obtaining consent, which shall be documented in the participant’s medical record.</text> </paragraph> <paragraph num="C."> <text>Medical Record Documentation. The provider shall:</text> <paragraph num="(1)"> <text>Maintain documentation in the same manner as during an in-person visit, using either electronic or paper medical records;</text> </paragraph> <paragraph num="(2)"> <text>Retain telehealth records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Include the participant's consent to participate in telehealth or an explanation as to why consent was not available.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An originating site may be any secure location, approved by the participant and the provider, for the delivery of telehealth services.</text> </paragraph> <paragraph num="E."> <text>Distant Site Providers may render services via telehealth within the provider's scope of practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Technical Requirements."> <paragraph num="A."> <text>A provider of services delivered through telehealth shall adopt and implement technology in a manner that supports the standard of care to deliver the required service.</text> </paragraph> <paragraph num="B."> <text>A service delivered through synchronous audio-visual telehealth shall, at a minimum, meet the following technology requirements:</text> <paragraph num="(1)"> <text>Cameras at both the originating and distant sites that provide clear, synchronous video of the patient and provider, respectively, with the ability to meet the clinical requirements of the service;</text> </paragraph> <paragraph num="(2)"> <text>Unless engaging in a telehealth with a participant who is deaf or hard of hearing, microphones and speakers at both the originating and distant sites, respectively, that provide clear, synchronous, two-way audio transmission;</text> </paragraph> <paragraph num="(3)"> <text>Network connectivity and bandwidth at both the originating and distant site sufficient to provide clear, synchronous two-way video and audio for the full duration of the service;</text> </paragraph> <paragraph num="(4)"> <text>Display monitor size sufficient to support diagnostic needs used in the telehealth services; and</text> </paragraph> <paragraph num="(5)"> <text>Utilize technology that meets the standards required by State and federal laws governing the privacy and security of protected health information (HIPAA compliant).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Confidentiality."> <text>The provider:</text> <paragraph num="A."> <text>Shall comply with all State and federal laws and regulations concerning the privacy and security of protected health information, including but not limited to:</text> <paragraph num="(1)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Shall ensure that all interactive video technology-assisted and audio-only communication comply with HIPAA patient privacy and security regulations throughout the transmission process;</text> </paragraph> <paragraph num="C."> <text>Shall occupy a space or area that meets the minimum standards for privacy expected for a patient-provider interaction;</text> </paragraph> <paragraph num="D."> <text>May not disseminate any participant images or information to other entities without the participant's consent, unless there is an emergency that prevents obtaining consent; and</text> </paragraph> <paragraph num="E."> <text>May not store the video images or audio portion of the service delivered via telehealth for future use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <paragraph num="A."> <text>A service delivered via telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for services delivered in person.</text> </paragraph> <paragraph num="B."> <text>A service delivered via telehealth does not include:</text> <paragraph num="(1)"> <text>An electronic mail message between a health care provider and a patient;</text> </paragraph> <paragraph num="(2)"> <text>A facsimile transmission between a health care provider and a patient; or</text> </paragraph> <paragraph num="(3)"> <text>A telephone conversation, electronic mail message, or facsimile transmission between providers without direct interaction with the patient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Store and forward technology does not meet the Maryland Medical Assistance Program's definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07.</text> </paragraph> <paragraph num="D."> <text>The provider may not bill the Maryland Medicaid Assistance Program for services delivered via telehealth when technical difficulties preclude the delivery of all or part of the telehealth session.</text> </paragraph> <paragraph num="E."> <text>The Department may not reimburse for services that:</text> <paragraph num="(1)"> <text>Require in-person evaluation; or</text> </paragraph> <paragraph num="(2)"> <text>Cannot be reasonably delivered via telehealth as specified in provider specific COMAR chapters, and subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A provider may not bill for facility, room, or board charges for telehealth visits if a professional fee can be billed separately.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reimbursements."> <paragraph num="A."> <text>To receive reimbursement for services delivered via telehealth, a provider shall:</text> <paragraph num="(1)"> <text>Be actively enrolled with Maryland Medical Assistance on the date the service is rendered; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with payment procedures as set forth in COMAR 10.09.36.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Distant Site Reimbursement.</text> <paragraph num="(1)"> <text>The distant site provider shall be reimbursed as set forth in the COMAR chapter defining the covered service being rendered.</text> </paragraph> <paragraph num="(2)"> <text>Services delivered via audio-visual telehealth shall be billed with the telehealth GT modifier.</text> </paragraph> <paragraph num="(3)"> <text>Services delivered via audio-only telehealth shall be billed with the UB modifier.</text> </paragraph> <paragraph num="(4)"> <text>Services delivered via telehealth shall be within the provider's scope of practice as determined by its governing licensure or credentialing board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Limitations."> <paragraph num="A."> <text>A service provided through telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for the service when provided in person.</text> </paragraph> <paragraph num="B."> <text>A telehealth service does not include:</text> <paragraph num="(1)"> <text>An audio-only telephone conversation between a health care provider and a patient;</text> </paragraph> <paragraph num="(2)"> <text>An electronic mail message between a health care provider and a patient;</text> </paragraph> <paragraph num="(3)"> <text>A facsimile transmission between a health care provider and a patient; or</text> </paragraph> <paragraph num="(4)"> <text>A telephone conversation, electronic mail message, or facsimile transmission between the originating and distant site providers without interaction between the distant site provider and the patient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Store and forward technology does not meet the Maryland Medical Assistance Program’s definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07.</text> </paragraph> <paragraph num="D."> <text>Telehealth-delivered services may not bill to the Maryland Medical Assistance Program or to the ASO when technical difficulties preclude the delivery of part or all of the telehealth session.</text> </paragraph> <paragraph num="E."> <text>The Department may not reimburse a provider for the following:</text> <paragraph num="(1)"> <text>Services that occur during an ambulance transport;</text> </paragraph> <paragraph num="(2)"> <text>Communications between providers where the participant is not physically present at the originating site;</text> </paragraph> <paragraph num="(3)"> <text>Telehealth services delivered where the originating site is not a permitted originating site provider as set forth in Regulation .06 of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>Mental health and substance use disorder services that did not receive prior authorization from the Department or its ASO.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department may not reimburse for services that:</text> <paragraph num="(1)"> <text>Require in-person evaluation; or</text> </paragraph> <paragraph num="(2)"> <text>Cannot be reasonably delivered via telehealth.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department may not reimburse distant site providers for a facility fee.</text> </paragraph> <paragraph num="H."> <text>The Department may not reimburse for home health monitoring services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reimbursement."> <paragraph num="A."> <text>To receive reimbursement for telehealth services, a provider shall:</text> <paragraph num="(1)"> <text>Be actively enrolled with Maryland Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>Participate with a telehealth partner that meets provider conditions for participation as set forth in Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>If a provider is a behavioral health service provider, be registered as a provider through the ASO on the date the service is rendered.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Distant Site Reimbursement.</text> <paragraph num="(1)"> <text>The distant site shall be reimbursed:</text> <paragraph num="(a)"> <text>For somatic services provided via telehealth, as set forth in COMAR 10.09.02.07D;</text> </paragraph> <paragraph num="(b)"> <text>For mental health services provided via telehealth, as set forth in COMAR 10.09.59.09; or</text> </paragraph> <paragraph num="(c)"> <text>For substance use disorder services provided via telehealth, as set forth in COMAR 10.09.80.08.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services delivered via telehealth shall be billed with the telehealth GT modifier.</text> </paragraph> <paragraph num="(3)"> <text>Services delivered via telehealth shall be within the provider’s scope of practice as determined by its governing licensure or credentialing board.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-105.2(b), Annotated Code of Maryland; Ch. 280, Acts of 2013; Ch. 366, Acts of 2016; Ch. 367, Acts of 2016</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 30, 2013 (40:19 Md. R. 1546)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 28, 2014 (41:8 Md. R. 471); December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, D amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471); October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, B amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11I, J adopted effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A, B amended effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed and new Regulation .12 adopted effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, D amended effective March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C, D amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 7, 2019 (46:20 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, F amended effective June 8, 2026 (53:11 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective June 8, 2026 (53:11 Md. R. 485)</annotation> </annotations> </chapter> <chapter num="50" heading="EPSDT School Health-Related Services or Health-Related Early Intervention Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Audiological evaluation” means identification, evaluation, and treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B.</text> </paragraph> <paragraph num="(2)"> <text>“Audiologist” means an individual licensed by the Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech Language Pathologists to practice audiology in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Audiology service” means treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B.</text> </paragraph> <paragraph num="(4)"> <text>“Dietitian-Nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Aversive technique” means the use of painful or noxious stimuli to the body, which is intrusive to the individual's physical, mental, or emotional well-being, used to terminate challenging or maladaptive behavior.</text> </paragraph> <paragraph num="(6)"> <text>“Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers.</text> </paragraph> <paragraph num="(7)"> <text>“Crisis intervention services” means the therapeutic response that provides immediate care or referral for an individual with an urgent mental health need.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(9)"> <text>“Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(10)"> <text>“Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09.</text> </paragraph> <paragraph num="(11)"> <text>“IEP team” means a group convened and conducted by a provider to develop a participant’s IEP, which is composed of a child’s parent or parents, the child’s teacher, and relevant service providers as indicated in COMAR 13A.05.01.03B and 13A.05.01.07.</text> </paragraph> <paragraph num="(12)"> <text>“Individualized Family Service Plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child’s family developed by an IFSP team pursuant to COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(13)"> <text>“IFSP team” means a group convened and conducted by a provider to develop a participant’s IFSP, which is composed of a child’s parent or parents, the child’s service coordinator, and relevant service providers as indicated in COMAR 13A.13.01.06.</text> </paragraph> <paragraph num="(14)"> <text>“Infants and toddlers with disabilities” means children from birth to the beginning of the school year following the child’s 4th birthday who are eligible for early intervention services, as described in COMAR 13A.13.01.03B and documented by appropriate licensed personnel as defined in COMAR 13A.13.01.03B.</text> </paragraph> <paragraph num="(15)"> <text>“Jurisdiction” means a state or the District of Columbia.</text> </paragraph> <paragraph num="(16)"> <text>“Local School System (LSS)” means any of the 24 public school systems in Maryland responsible for providing public elementary or secondary education.</text> </paragraph> <paragraph num="(17)"> <text>“Local lead agency” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the State Department of Education in accordance with Education Article, §8-416, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Maladaptive behavior” means behavior that is:</text> <paragraph num="(a)"> <text>Harmful to oneself or others;</text> </paragraph> <paragraph num="(b)"> <text>Developmentally inappropriate; and</text> </paragraph> <paragraph num="(c)"> <text>Disruptive or dangerous.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Maryland State Department of Education” has the meaning stated in COMAR 13A.01.03.</text> </paragraph> <paragraph num="(20)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(21)"> <text>“Mental health professional” has the meaning stated in COMAR 10.21.17.02B.</text> </paragraph> <paragraph num="(22)"> <text>“Nurse” means an individual who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(23)"> <text>“Nursing care plan” means a plan developed by a registered nurse that identifies the patient’s diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient’s medical condition as defined in COMAR 10.09.53.01B.</text> </paragraph> <paragraph num="(24)"> <text>Nursing Services.</text> <paragraph num="(a)"> <text>“Nursing services” means skilled nursing services performed by a licensed nurse for a participant, which are necessary for the participant to benefit from educational or early intervention services pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B.</text> </paragraph> <paragraph num="(b)"> <text>“Nursing services” includes an initial assessment.</text> </paragraph> <paragraph num="(c)"> <text>“Nursing services” does not include:</text> <paragraph num="(i)"> <text>Routine assessments of recipients whose medical condition is stable, unless the assessment leads to an intervention or change in the nursing care plan;</text> </paragraph> <paragraph num="(ii)"> <text>Administration of medications;</text> </paragraph> <paragraph num="(iii)"> <text>Supervision of interventions which the child is able to perform independently;</text> </paragraph> <paragraph num="(iv)"> <text>Health screens;</text> </paragraph> <paragraph num="(v)"> <text>Health education, except one-on-one training regarding self-management of the child's medical condition;</text> </paragraph> <paragraph num="(vi)"> <text>First aid interventions;</text> </paragraph> <paragraph num="(vii)"> <text>Services not directly related to the nursing care plan; and</text> </paragraph> <paragraph num="(viii)"> <text>Services not deemed medically necessary at the initial assessment or the most recent nursing care plan review.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(25)"> <text>Nutrition Services.</text> <paragraph num="(a)"> <text>“Nutrition services” means services delivered by a licensed dietitian nutritionist.</text> </paragraph> <paragraph num="(b)"> <text>“Nutrition services” includes:</text> <paragraph num="(i)"> <text>Nutrition assessments and evaluations;</text> </paragraph> <paragraph num="(ii)"> <text>Developing and monitoring appropriate plans to address the nutritional needs of eligible children; and</text> </paragraph> <paragraph num="(iii)"> <text>Making referrals to appropriate community resources to carry out nutrition goals in an IFSP pursuant to COMAR 13A.13.01.03B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“Occupational therapy assistant” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice limited occupational therapy in Maryland.</text> </paragraph> <paragraph num="(28)"> <text>“Occupational therapy services” means occupational therapy evaluations or treatments delivered by a licensed occupational therapist, or treatments delivered by a licensed occupational therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B.</text> </paragraph> <paragraph num="(29)"> <text>“Parent” means the parent of a child and includes:</text> <paragraph num="(a)"> <text>A biological or adoptive parent;</text> </paragraph> <paragraph num="(b)"> <text>A legal guardian;</text> </paragraph> <paragraph num="(c)"> <text>Another person responsible for a child's welfare; or</text> </paragraph> <paragraph num="(d)"> <text>A parent surrogate for those cases when:</text> <paragraph num="(i)"> <text>A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent,</text> </paragraph> <paragraph num="(ii)"> <text>An individual cannot be identified with responsibility for a child's welfare, or</text> </paragraph> <paragraph num="(iii)"> <text>A child is a ward of the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Participant” means a Medical Assistance recipient who is eligible for and receives school-based health-related services.</text> </paragraph> <paragraph num="(31)"> <text>“Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice physical therapy in Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Physical therapist assistant” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice limited physical therapy in Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Physical therapy services” means physical therapy evaluations or treatments, delivered by a licensed physical therapist, or treatments delivered by a licensed physical therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B.</text> </paragraph> <paragraph num="(34)"> <text>“Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(35)"> <text>“Provider” means a local school system, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation as defined in Regulation .03 of this chapter to provide school-based health-related services.</text> </paragraph> <paragraph num="(36)"> <text>“Psychological services” means the delivery of services by a qualified licensed mental health professional, including administering psychological and developmental tests and other assessment procedures, interpreting assessment results, obtaining, integrating, and interpreting information about child behavior and child and family conditions related to learning, mental health, and development, and planning and managing a program of psychological services including psychological counseling for children and families.</text> </paragraph> <paragraph num="(37)"> <text>“Rehabilitative service” means the medical or remedial service recommended by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland within the scope of the practice under §B(36) of this regulation, for the reduction of maladaptive behavior and restoration of a recipient to the best possible functional level.</text> </paragraph> <paragraph num="(38)"> <text>“School psychologist” means an individual certified by the Maryland State Department of Education to provide psychological services in a school-based setting.</text> </paragraph> <paragraph num="(39)"> <text>“Special health needs” means those temporary or long-term health problems arising from physical, emotional, or social factors, or any combination of these.</text> </paragraph> <paragraph num="(40)"> <text>“Speech-language pathologist” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech language pathology in Maryland.</text> </paragraph> <paragraph num="(41)"> <text>“Speech-language pathology assistant” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to assist in the practice of speech language pathology in Maryland.</text> </paragraph> <paragraph num="(42)"> <text>“Speech-language pathology” means speech language evaluations, diagnoses or treatments delivered by a licensed speech-language pathologist, or treatments delivered by a licensed speech-language pathology assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B.</text> </paragraph> <paragraph num="(43)"> <text>“Therapeutic behavioral aide” means an individual who has been trained to implement a behavior plan as specified in the IEP or IFSP under the supervision of a licensed physician or authorized practitioner pursuant to Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(44)"> <text>“Therapeutic behavioral service” means a one-to-one individualized rehabilitative service, rendered by a therapeutic behavioral aide, using appropriate methods of preventing or decreasing maladaptive behaviors for a Medicaid recipient who is eligible for and receives health-related services in an IEP or health-related early intervention services in an IFSP.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure and Certification."> <paragraph num="A."> <text>A provider shall ensure that the provider's employees who render school health-related services meet the licensure or certification requirements for their profession, as specified in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>A professional employed by a provider shall have the following qualifications:</text> <paragraph num="(1)"> <text>An audiologist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(2)"> <text>A professional counselor shall be licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland, in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(3)"> <text>A nurse shall be a registered nurse or a practical nurse licensed to practice in the jurisdiction in which services are provided:</text> </paragraph> <paragraph num="(4)"> <text>A nurse psychotherapist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(5)"> <text>A dietitian-nutritionist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(6)"> <text>An occupational therapist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(7)"> <text>An occupational therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed occupational therapist;</text> </paragraph> <paragraph num="(8)"> <text>A physical therapist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(9)"> <text>A physical therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed physical therapist;</text> </paragraph> <paragraph num="(10)"> <text>A psychiatrist shall be a physician licensed to practice in the jurisdiction in which services are provided who is certified by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to take the Board examination;</text> </paragraph> <paragraph num="(11)"> <text>A psychologist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(12)"> <text>A school psychologist shall be certified in accordance with COMAR 13A.12.04.09 to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(13)"> <text>A social worker shall be licensed as:</text> <paragraph num="(a)"> <text>A master social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(b)"> <text>A certified social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; or</text> </paragraph> <paragraph num="(c)"> <text>A certified social worker-clinical in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>A speech language pathologist shall be licensed to practice in the jurisdiction in which services are provided;</text> </paragraph> <paragraph num="(15)"> <text>A speech language pathology assistant shall be licensed to practice in the jurisdiction in which services are provided under the supervision of a licensed speech language pathologist; and</text> </paragraph> <paragraph num="(16)"> <text>A therapeutic behavioral provider shall be approved by the Department in accordance with COMAR 10.09.50.05A.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in EPSDT school health-related or health-related early intervention services are that a:</text> <paragraph num="(1)"> <text>Provider shall:</text> <paragraph num="(a)"> <text>Meet all the requirements for participation in the Program as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(b)"> <text>Collaborate in the provision of covered services with local health departments in accordance with Education Article, §7-401, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Therapeutic behavioral aide shall be:</text> <paragraph num="(a)"> <text>Trained in the principles of behavioral management and appropriate methods of preventing or decreasing maladaptive behaviors relevant to the recipient's behavioral needs; and</text> </paragraph> <paragraph num="(b)"> <text>Supervised by a licensed physician or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program require that the provider maintain adequate documentation of all services provided, which at a minimum, includes:</text> <paragraph num="(1)"> <text>The location, date, start, and end time of the service;</text> </paragraph> <paragraph num="(2)"> <text>A brief description of the service; and</text> </paragraph> <paragraph num="(3)"> <text>A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in §B and C of this regulation when the services are:</text> <paragraph num="(1)"> <text>Necessary to identify the need for a health-related service or health-related early intervention service;</text> </paragraph> <paragraph num="(2)"> <text>Necessary to:</text> <paragraph num="(a)"> <text>Prevent disease, disability, and other health conditions or their progression; and</text> </paragraph> <paragraph num="(b)"> <text>Promote physical and mental health and efficiency;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Necessary for the maximum reduction of physical or mental disability and restoration of a participant to the participant's best possible functional level; and;</text> </paragraph> <paragraph num="(4)"> <text>Rendered in accordance with accepted professional standards.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following services are covered under this chapter when delivered in accordance with an IEP or an IFSP, which is developed at the time of referral for health-related services or health-related early intervention services:</text> <paragraph num="(1)"> <text>Audiology services, which include the identification, evaluation, and treatment of auditory impairments;</text> </paragraph> <paragraph num="(2)"> <text>Nursing services, which:</text> <paragraph num="(a)"> <text>Are related to an identified health problem;</text> </paragraph> <paragraph num="(b)"> <text>Except for nursing assessments, are ordered by a licensed prescriber;</text> </paragraph> <paragraph num="(c)"> <text>Are indicated in the nursing care plan, which is reviewed at least every 60 days and more frequently when the child's medical condition changes; and</text> </paragraph> <paragraph num="(d)"> <text>Require the judgment, knowledge, and skills of a licensed nurse;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Nutrition services which include conducting assessments of nutritional history and dietary intake and developing and monitoring appropriate plans to address a participant’s nutritional needs;</text> </paragraph> <paragraph num="(4)"> <text>Occupational therapy services, which include any screening, evaluations, or treatments necessary to implement a program of activities, with the goal to develop or maintain the adaptive skills necessary to achieve a participant’s adequate and appropriate physical and mental functioning;</text> </paragraph> <paragraph num="(5)"> <text>Physical therapy services, which include screening and evaluations necessary to determine a participant’s level of functioning, as well as any treatment, which may use therapeutic exercises for the purpose of preventing, restoring, or alleviating a movement dysfunction and related functional problems;</text> </paragraph> <paragraph num="(6)"> <text>Psychological services, which include the evaluation, diagnosis, and treatment of emotional or behavioral problems in order for a participant to benefit from an educational or early intervention program including the counseling of parents and parent training when the participant is present;</text> </paragraph> <paragraph num="(7)"> <text>Speech-language pathology services, which include, diagnosis, evaluation, or treatment; and</text> </paragraph> <paragraph num="(8)"> <text>Therapeutic behavioral services which:</text> <paragraph num="(a)"> <text>Includes one-to-one services by a trained therapeutic behavior aide; and</text> </paragraph> <paragraph num="(b)"> <text>Is supervised by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Psychological services, as described in §B(6) of this regulation, are covered under this chapter even if the services are not delivered in accordance with an IEP or an IFSP.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>To participate in the Program as a provider of health-related services or health-related early intervention services, the provider shall be a local school system, a local lead agency, a State-operated education agency, or State-supported education agency.</text> </paragraph> <paragraph num="B."> <text>Health-related services or health-related early intervention services outlined in the IEP or the IFSP shall be approved by the IEP or IFSP team for continued treatment.</text> </paragraph> <paragraph num="C."> <text>Therapeutic behavioral services may only be provided if:</text> <paragraph num="(1)"> <text>Preauthorized through the IEP or IFSP process and directly related to the IEP or IFSP;</text> </paragraph> <paragraph num="(2)"> <text>Services are not custodial;</text> </paragraph> <paragraph num="(3)"> <text>Services are considered medically necessary by the IEP or IFSP team, which develops the recipient’s IEP or IFSP;</text> </paragraph> <paragraph num="(4)"> <text>Delivered in the recipient's home, school, or other setting if normal activities are disrupted;</text> </paragraph> <paragraph num="(5)"> <text>The therapeutic behavioral aide is not a member of the recipient's immediate family or an individual who ordinarily resides in the recipient's home; and</text> </paragraph> <paragraph num="(6)"> <text>The recipient has:</text> <paragraph num="(a)"> <text>Maladaptive behavior;</text> </paragraph> <paragraph num="(b)"> <text>Warrants a behavioral plan;</text> </paragraph> <paragraph num="(c)"> <text>Behavior that is deviant from developmentally appropriate behavior for the individual’s chronological age as determined by the IEP or IFSP team;</text> </paragraph> <paragraph num="(d)"> <text>A behavior plan that does not include aversive techniques, restraints, and seclusion, or any of these; and</text> </paragraph> <paragraph num="(e)"> <text>No insurance coverage for therapeutic behavior services when compensated as an individual service covered by another third party insurance or part of a package of benefits covered by either another third party insurance or another public agency.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization."> <paragraph num="A."> <text>Therapeutic behavioral services shall be preauthorized through the IEP or IFSP process.</text> </paragraph> <paragraph num="B."> <text>Psychological services that are not delivered in accordance with an IEP or IFSP shall be preauthorized by the Administrative Services Organization in accordance with COMAR 10.09.59.08.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider shall submit a request for payment of services rendered and completed under this chapter as set forth in COMAR 10.09.36.04. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The completed form shall indicate the:</text> <paragraph num="(a)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(c)"> <text>Provider's name, location, and provider number; and</text> </paragraph> <paragraph num="(d)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Providers may not bill the Program for:</text> <paragraph num="(1)"> <text>Services not rendered in person, unless the services are provided in compliance with COMAR 10.09.49 and any guidance issued by the Department:</text> </paragraph> <paragraph num="(2)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(3)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(4)"> <text>Services which duplicate a service that a recipient is receiving under another medical care program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program may not make direct payment to a participant.</text> </paragraph> <paragraph num="D."> <text>Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="E."> <text>Reimbursement for health-related services and health-related early intervention services is contained in COMAR 10.09.02.07D. The State portion of reimbursement is provided by the Maryland State Department of Education.</text> </paragraph> <paragraph num="F."> <text>Psychological services not delivered in accordance with an IEP or IFSP are reimbursable when they are:</text> <paragraph num="(1)"> <text>Rendered by a school psychologist or school social worker that:</text> <paragraph num="(a)"> <text>Meets the qualifications of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled with the Medicaid Program in accordance with COMAR 10.09.36; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Billed by a local education agency in accordance with COMAR 10.09.59.09.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement is as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures are set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>Interpretive regulations are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-124, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective February 2, 1993 (20:4 Md. R. 369); adopted permanently effective June 1, 1993 (20:10 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 and .06 amended as an emergency provision effective September 19, 1997 (24:21 Md. R. 1445); amended permanently effective December 29, 1997 (24:26 Md. R. 1759)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .04, and .05 amended effective June 25, 2001 (28:12 Md. R. 1106)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .02B, and .04—.06 amended as an emergency provision effective September 2, 1994 (21:20 Md. R. 1729); amended permanently effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1083); amended permanently effective November 4, 1996 (23:22 Md. R. 1497)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective December 17, 2002 (30:1 Md. R. 22); emergency status extended at 30:14 Md. R. 933; revised permanently effective August 4, 2003 (30:15 Md. R. 991)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 386); May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective September 26, 2016 (43:19 Md. R. 1072); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E, F amended effective November 14, 2011 (38:23 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 386); February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F repealed effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F adopted effective May 12, 2025 (52:9 Md. R. 405)</annotation> </annotations> </chapter> <chapter num="51" heading="Audiology Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Audiologist” means a professional who is licensed in accordance with Regulation .02 of this chapter who treats hearing disorders and communication problems.</text> </paragraph> <paragraph num="(2)"> <text>“Audiology assessment” means procedures performed by an audiologist to evaluate and monitor the status of the peripheral auditory system, auditory nerve, and central auditory system, or to establish the site of the auditory disorder by using procedures to quantify and qualify hearing loss by site of lesion, on the basis of perceptual, physiological, or electrophysiological responses to acoustic stimuli, and to describe any communicative disorders.</text> </paragraph> <paragraph num="(3)"> <text>Audiology Center.</text> <paragraph num="(a)"> <text>“Audiology center” means a multispecialty setting with all necessary equipment for audiology services that operates for the purpose of providing preventive, diagnostic, therapeutic, and rehabilitative audiology services, and other multispecialty services by or under the direction of a licensed physician or audiologist.</text> </paragraph> <paragraph num="(b)"> <text>“Audiology center” does not include the office of one or more private audiologists.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Audiology services” means services delivered by an audiologist to eligible participants in order to diagnose and treat hearing problems.</text> </paragraph> <paragraph num="(5)"> <text>“Auditory osseointegrated device” means a device implanted in the skull that replaces the function of the middle ear and provides mechanical energy to the cochlea via a mechanical transducer.</text> </paragraph> <paragraph num="(6)"> <text>“Bilateral” means relating to or involving both ears.</text> </paragraph> <paragraph num="(7)"> <text>“Cochlear implant” means a device that is implanted under the skin that picks up sounds and converts them to impulses transmitted to electrodes placed in the cochlea, restoring some hearing to people with a hearing impairment.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(9)"> <text>“Designee” means any entity designated to act on behalf of the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals under 21 years old.</text> </paragraph> <paragraph num="(11)"> <text>“EPSDT screening provider” means a physician, audiologist, or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Hearing aid” means an instrument or device that is designed for improving or correcting impaired human hearing, or any part or accessory of the instrument or device.</text> </paragraph> <paragraph num="(13)"> <text>“Hearing aid dispenser” means a person who is licensed in accordance with Regulation .02 of this chapter to sell hearing aids or provide other hearing aid services.</text> </paragraph> <paragraph num="(14)"> <text>“Hearing aid evaluation” means services provided to a participant by an audiologist for determining the benefit of hearing aids and, upon the audiologist’s recommendation, the dispensing of hearing aids.</text> </paragraph> <paragraph num="(15)"> <text>“Maryland Medical Assistance Program (Program)” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals.</text> </paragraph> <paragraph num="(16)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Participant” means an individual who is enrolled with the Department to receive Medical Assistance services.</text> </paragraph> <paragraph num="(18)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(19)"> <text>“Provider” means an audiologist, audiology center, or hearing aid dispenser that is licensed and that, through an agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(20)"> <text>“Unilateral” means relating to, involving, or affecting one ear.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure Requirements."> <paragraph num="A."> <text>In order to provide services as an audiologist under this chapter, an audiologist shall be licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice audiology, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction in which the audiology services are performed.</text> </paragraph> <paragraph num="B."> <text>In order to provide services as a hearing aid dispenser under this chapter, a hearing aid dispenser shall be licensed by the:</text> <paragraph num="(1)"> <text>State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to dispense hearing aids and hearing aid accessories, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Appropriate licensing body in the jurisdiction in which the hearing aids are dispensed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as an audiologist, audiology center or group, or hearing aid dispenser are that the provider:</text> <paragraph num="(1)"> <text>Shall meet the licensure requirements in accordance with Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>May not knowingly employ another person to provide services to Maryland Medical Assistance Program participants after that person has been disqualified from the Program unless prior approval has been received from the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following medically necessary services:</text> <paragraph num="A."> <text>Audiology services, as follows:</text> <paragraph num="(1)"> <text>For participants who are at risk for or have a hearing impairment, audiology assessments using procedures appropriate for the participant’s developmental age and abilities; and</text> </paragraph> <paragraph num="(2)"> <text>Hearing aid evaluations and routine follow-up for participants with an identified hearing impairment, who currently use or are being considered for hearing aids; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearing amplification services, as follows:</text> <paragraph num="(1)"> <text>Unilateral or bilateral hearing aids which are medically necessary and are:</text> <paragraph num="(a)"> <text>Not used or rebuilt, and which meet the current standards set forth in 21 CFR §§801.420 and 801.421, which are incorporated by reference;</text> </paragraph> <paragraph num="(b)"> <text>Recommended and fitted by an audiologist in conjunction with written medical clearance from a physician who has performed a medical examination within the past 6 months;</text> </paragraph> <paragraph num="(c)"> <text>Sold on a 30-day trial basis; and</text> </paragraph> <paragraph num="(d)"> <text>Fully covered by a manufacturer’s warranty for a minimum of 2 years, at no cost to the Program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Hearing aid accessories and services, as listed below:</text> <paragraph num="(a)"> <text>Ear molds;</text> </paragraph> <paragraph num="(b)"> <text>Batteries;</text> </paragraph> <paragraph num="(c)"> <text>Routine follow-ups and adjustments;</text> </paragraph> <paragraph num="(d)"> <text>Repairs after all warranties have expired;</text> </paragraph> <paragraph num="(e)"> <text>Replacement of unilateral or bilateral hearing aids every 5 years when determined to be medically necessary; and</text> </paragraph> <paragraph num="(f)"> <text>Other hearing aid accessories determined to be medically necessary;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Cochlear implants and related services, as listed below:</text> <paragraph num="(a)"> <text>Unilateral or bilateral implantation of cochlear implant or implants which are medically necessary including the cost of the device;</text> </paragraph> <paragraph num="(b)"> <text>Post-operative evaluation and programming of the cochlear implant or implants;</text> </paragraph> <paragraph num="(c)"> <text>Aural rehabilitation services; and</text> </paragraph> <paragraph num="(d)"> <text>Repair or replacement of cochlear implant device components subject to the limitations in Regulation .05 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Auditory osseointegrated device or devices and related services, as listed below:</text> <paragraph num="(a)"> <text>Unilateral or bilateral implantation of auditory osseointegrated devices which are medically necessary including the cost of the device;</text> </paragraph> <paragraph num="(b)"> <text>Non-implantable or softband device or devices which are medically necessary;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation and programming of the auditory osseointegrated device or devices; and</text> </paragraph> <paragraph num="(d)"> <text>Repair or replacement, or both, of auditory osseointegrated device components subject to the limitations in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Covered audiology services, including hearing aids, cochlear implants, and auditory osseointegrated devices are limited to:</text> <paragraph num="(1)"> <text>Unless the time limitation is waived by the Program, one audiology assessment per year;</text> </paragraph> <paragraph num="(2)"> <text>The initial coverage of unilateral or bilateral hearing aids, cochlear implants, or auditory osseointegrated devices when the Department’s medical necessity criteria have been met;</text> </paragraph> <paragraph num="(3)"> <text>One replacement of unilateral or bilateral hearing aids:</text> <paragraph num="(a)"> <text>Every 5 years for participants younger than 21 years old, unless the Program approves more frequent replacement; or</text> </paragraph> <paragraph num="(b)"> <text>Every 5 years for participants 21 years old or older, unless the Program approves more frequent replacement, but no more than 1 replacement extraneous to the devices’ warranty;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Replacement of hearing aids, cochlear implants and auditory osseointegrated device components that have been lost, stolen, or damaged beyond repair, after all warranties have expired;</text> </paragraph> <paragraph num="(5)"> <text>Repairs and replacements that take place after all warranties have expired;</text> </paragraph> <paragraph num="(6)"> <text>A maximum of 76 batteries per participant per 12-month period for a unilateral hearing aid or osseointegrated devices, or 152 batteries per participant per 12-month period for bilateral hearing aids or osseointegrated devices purchased from the Department not more frequently than every 6 months, and in quantities of 38 or fewer for a unilateral hearing aid, or 76 or fewer for a bilateral hearing aid;</text> </paragraph> <paragraph num="(7)"> <text>A maximum of 238 disposable batteries for a unilateral cochlear implant per participant per 12-month period or 476 disposable batteries per 12-month period for a bilateral cochlear implant purchased not more frequently than every 6 months, and in quantities of 119 or fewer for a unilateral cochlear implant, or 238 or fewer for a bilateral cochlear implant;</text> </paragraph> <paragraph num="(8)"> <text>Four replacement cochlear implant component rechargeable batteries per 12-month period for bilateral cochlear implants, and a maximum of two replacement rechargeable batteries for a unilateral cochlear implant per 12-month period;</text> </paragraph> <paragraph num="(9)"> <text>Two cochlear implant replacement transmitter cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitter cable for a unilateral cochlear implant per 12-month period;</text> </paragraph> <paragraph num="(10)"> <text>Two cochlear implant replacement headset cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement headset cable for a unilateral cochlear implant per 12-month period;</text> </paragraph> <paragraph num="(11)"> <text>Two replacement cochlear implant transmitting coils per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitting coil for a unilateral cochlear implant per 12-month period;</text> </paragraph> <paragraph num="(12)"> <text>Charges for routine follow-ups and adjustments which occur more than 60 days after the dispensing of a new hearing aid; and</text> </paragraph> <paragraph num="(13)"> <text>A maximum of two unilateral earmolds or four bilateral earmolds per 12-month period unless a larger number is determined to be medically necessary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services which are not covered are:</text> <paragraph num="(1)"> <text>Services not medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Hearing aids and accessories not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Cochlear implant services and external components not medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>Cochlear implant services and external components provided less than 90 days after the surgery which are covered through the initial reimbursement;</text> </paragraph> <paragraph num="(5)"> <text>Spare or backup cochlear implant components;</text> </paragraph> <paragraph num="(6)"> <text>Spare or back-up auditory osseointegrated device components;</text> </paragraph> <paragraph num="(7)"> <text>Replacement of hearing aids, equipment, cochlear implant components, and auditory osseointegrated device components if the existing devices are functional, repairable, and appropriately correct or ameliorate the problem or condition;</text> </paragraph> <paragraph num="(8)"> <text>Spare or backup hearing aids, equipment, or supplies;</text> </paragraph> <paragraph num="(9)"> <text>Repairs to spare or backup hearing aids, cochlear implants, auditory osseointegrated devices, equipment, or supplies;</text> </paragraph> <paragraph num="(10)"> <text>Investigational or experimental services or devices, or both;</text> </paragraph> <paragraph num="(11)"> <text>Replacement of improperly fitted earmold or earmolds unless the:</text> <paragraph num="(a)"> <text>Replacement service is administered by someone other than the original provider; and</text> </paragraph> <paragraph num="(b)"> <text>Replacement service has not been claimed before;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Additional professional fees and overhead charges for a new hearing aid when a dispensing fee claim has been made to the Program; and</text> </paragraph> <paragraph num="(13)"> <text>Loaner hearing aids.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The Department requires preauthorization for the following services:</text> <paragraph num="(1)"> <text>All hearing aids;</text> </paragraph> <paragraph num="(2)"> <text>Certain hearing aid accessories;</text> </paragraph> <paragraph num="(3)"> <text>All cochlear implant devices and replacement components except microphone, transmitter cables, and transmitting coils;</text> </paragraph> <paragraph num="(4)"> <text>All auditory osseointegrated devices; and</text> </paragraph> <paragraph num="(5)"> <text>Repairs for hearing aids, cochlear implants, and auditory osseointegrated components exceeding $500.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preauthorization is valid:</text> <paragraph num="(1)"> <text>For services rendered or initiated within 6 months from the date the preauthorization was issued; and</text> </paragraph> <paragraph num="(2)"> <text>If the patient is an eligible participant at the time the service is rendered.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The following written documentation shall be submitted by the provider to the Department or its designee with each request or preauthorization of hearing aids, cochlear implants, or auditory osseointegrated devices:</text> <paragraph num="(1)"> <text>Audiology report documenting medical necessity of the hearing aids, cochlear implants or auditory osseointegrated devices;</text> </paragraph> <paragraph num="(2)"> <text>Interpretation of the audiogram; and</text> </paragraph> <paragraph num="(3)"> <text>Medical evaluation by a physician supporting the medical necessity of the initial hearing aids, cochlear implants, or auditory osseointegrated devices within 6 months of the preauthorization request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>To obtain compensation from the Department for covered services, the provider shall submit a request for payment using the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>Audiology services are reimbursed in accordance with COMAR 10.09.23.01-1.</text> </paragraph> <paragraph num="C."> <text>The provider shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge to the general public, unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The rate in accordance with the Department’s fee schedule.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider may not bill the Department or participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Audiology centers licensed as a part of a hospital may charge for and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC), set forth in COMAR 10.37.03.</text> </paragraph> <paragraph num="F."> <text>The provider shall refund to the Department payment for hearing aids, supplies, or both, that have been returned to the manufacturer within the 30-day trial period.</text> </paragraph> <paragraph num="G."> <text>The provider shall give the Department the full advantage of any and all manufacturer’s warranties and trade-ins offered on hearing aids, equipment, or both.</text> </paragraph> <paragraph num="H."> <text>Unless preauthorization has been granted by the Department or its designee, the Department is not responsible for any reimbursement to a provider for any service provided which requires preauthorization.</text> </paragraph> <paragraph num="I."> <text>The Department may not make direct payment to participants.</text> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement requirements are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretation of State Regulations."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 16, 1993 (20:16 Md. R. 1277)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 21, 2004 (31:12 Md. R. 911)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 18, 2005 (32:14 Md. R. 1275); January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 16, 2006 (33:1 Md. R. 36)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 18, 2005 (32:14 Md. R. 1275); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 16, 2006 (33:1 Md. R. 36)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 18, 2005 (32:14 Md. R. 1275)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective January 16, 2006 (33:1 Md. R. 36)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, D amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 16, 2006 (33:1 Md. R. 36); April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective April 21, 2008 (35:8 Md. R. 805); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, G, K amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> </annotations> </chapter> <chapter num="52" heading="Service Coordination for Children with an IEP or Enrolled in the Autism Waiver"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Autism” has the meaning stated in COMAR 10.09.56.01C.</text> </paragraph> <paragraph num="(2)"> <text>“Autism Waiver” or “Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder.</text> </paragraph> <paragraph num="(3)"> <text>“Autism Waiver Service Coordination” means the coordination of waiver services covered under this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Autism Waiver Service Coordinator” means an individual who meets the requirements specified in Regulation .03-1 of this chapter and provides the autism waiver services specified in Regulations .04-1—04.2 of this chapter to a waiver participant.</text> </paragraph> <paragraph num="(5)"> <text>“Department” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(6)"> <text>“Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under COMAR 10.09.56 in accordance with the document and any amendments to it submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to Section 1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program.</text> </paragraph> <paragraph num="(7)"> <text>“IEP service coordination” means the coordination of services which assists a participant in gaining access to the services recommended in the participant’s IEP.</text> </paragraph> <paragraph num="(8)"> <text>“IEP service coordinator” means an individual who meets the requirements in Regulation .03C of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Individualized Education Program (IEP)” means a written, individualized plan of care for a participant, that:</text> <paragraph num="(a)"> <text>Is developed by an IEP team on a form approved by MSDE;</text> </paragraph> <paragraph num="(b)"> <text>Recommends the special education and related services to meet a participant's needs; and</text> </paragraph> <paragraph num="(c)"> <text>Conforms with the requirements in COMAR 13A.05.01 and 34 CFR §§300.320—300-324.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Individualized education program (IEP) team” means the multidisciplinary team convened by a provider in accordance with COMAR 13A.05.01 to review a participant’s needs, develop the participant’s IEP, and determine the placement of the participant in the least restrictive environment.</text> </paragraph> <paragraph num="(11)"> <text>“Individualized family service plan (IFSP)” means a written, individualized plan for providing early intervention and other services for an infant, toddler, or preschool-age child, in accordance with COMAR 13A.13.01.</text> </paragraph> <paragraph num="(12)"> <text>“Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the Maryland State Department of Education.</text> </paragraph> <paragraph num="(13)"> <text>“Local school system (LSS)” means any public school system in Maryland responsible for providing public elementary or secondary education.</text> </paragraph> <paragraph num="(14)"> <text>“Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.67.01.01.</text> </paragraph> <paragraph num="(15)"> <text>“Maryland State Department of Education (MSDE)” is the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws.</text> </paragraph> <paragraph num="(16)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(17)"> <text>“Parent” has the meaning stated in COMAR 13A.13.01.03.</text> </paragraph> <paragraph num="(18)"> <text>“Participant” means an individual who meets the qualifications for participation in the services covered under this chapter, as specified in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(19)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(20)"> <text>“Provider” means an agency which meets the conditions for participation, as specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder.</text> </paragraph> <paragraph num="(22)"> <text>“Rare and expensive case management (REM)” has the meaning stated in COMAR 10.09.69.02.</text> </paragraph> <paragraph num="(23)"> <text>“Telehealth” has the meaning as stated in COMAR 10.09.49.02.</text> </paragraph> <paragraph num="(24)"> <text>“Waiver eligible person” means an individual who meets the qualifications, as specified in COMAR 10.09.56, for participation in the Autism Waiver.</text> </paragraph> <paragraph num="(25)"> <text>“Waiver multidisciplinary team” means the team, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a waiver applicant or waiver participant.</text> </paragraph> <paragraph num="(26)"> <text>“Waiver participant” means a waiver eligible person who is enrolled in the Autism Waiver.</text> </paragraph> <paragraph num="(27)"> <text>“Waiver plan of care” means the written, individualized treatment plan which preauthorizes the specific Autism Waiver services to be provided to a waiver participant, as covered under COMAR 10.09.56.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Participant Eligibility."> <text>A participant is eligible for Service Coordination if:</text> <paragraph num="A."> <text>The individual is enrolled as a waiver participant in accordance with the requirements of COMAR 10.09.56 and this chapter; or</text> </paragraph> <paragraph num="B."> <text>The following requirements are met:</text> <paragraph num="(1)"> <text>The participant, for whom free and appropriate education is provided under the Individuals with Disabilities Education Act, is aged 3 through 20 years old;</text> </paragraph> <paragraph num="(2)"> <text>An IEP team determines that the participant is a child with disabilities who:</text> <paragraph num="(a)"> <text>Is eligible for special education and related services, and</text> </paragraph> <paragraph num="(b)"> <text>Needs an IEP;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The participant elects, or the participant’s parent elects on the participant’s behalf, to receive the services available under this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>The participant is not a resident of any of the facilities that receive Medicaid reimbursement for residential services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation for IEP Service Coordination Providers."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>IEP service coordination providers shall:</text> <paragraph num="(1)"> <text>Be an agency within the State that:</text> <paragraph num="(a)"> <text>Operates programs with special education and related services for children with disabilities, in accordance with COMAR 13A.05.01; and</text> </paragraph> <paragraph num="(b)"> <text>Is eligible to receive, through MSDE, funding from Assistance to States for the Education of Children with Disabilities under Part B of the Individuals with Disabilities Education Act;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Convene or participate on an IEP team or teams, in accordance with COMAR 13A.05.01;</text> </paragraph> <paragraph num="(3)"> <text>Designate specific, qualified individuals as service coordinators, and verify their credentials for providing the services covered under this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants;</text> </paragraph> <paragraph num="(5)"> <text>Maintain a file on each participant which meets the Program’s requirements which shall include:</text> <paragraph num="(a)"> <text>Copies of the participant's IEP with any revisions;</text> </paragraph> <paragraph num="(b)"> <text>Written parental consent to initiate services covered under this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Written parental consent prior to accessing the student’s public benefits or insurance the first time, and annually thereafter, in accordance with 34 CFR §300.154(d)(2);</text> </paragraph> <paragraph num="(d)"> <text>Approval from a participant’s parent of the participant’s IEP before implementation of the IEP service coordination; and</text> </paragraph> <paragraph num="(e)"> <text>A record of IEP service coordination encounters including:</text> <paragraph num="(i)"> <text>A brief description of the service;</text> </paragraph> <paragraph num="(ii)"> <text>The location;</text> </paragraph> <paragraph num="(iii)"> <text>The name of the contact (parent/guardian or student);</text> </paragraph> <paragraph num="(iv)"> <text>The date of the service; and</text> </paragraph> <paragraph num="(v)"> <text>The IEP service coordinator’s printed name and signature; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Employ or have under contract qualified personnel who convene or participate on IEP teams, convene or participate on multidisciplinary teams as necessary, and develop participants’ IEPs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>IEP Service Coordinator Requirements.</text> <paragraph num="(1)"> <text>An IEP service coordinator shall:</text> <paragraph num="(a)"> <text>Be employed by or under contract with a provider;</text> </paragraph> <paragraph num="(b)"> <text>Be identified by the IEP team ;</text> </paragraph> <paragraph num="(c)"> <text>Participate with the IEP team in the development or revision of a participant’s IEP and in the IEP review;</text> </paragraph> <paragraph num="(d)"> <text>Assist the participant in gaining access to the services recommended in the IEP; and</text> </paragraph> <paragraph num="(e)"> <text>Collect and synthesize evaluation reports and other relevant information about a participant that might be needed by an IEP team.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An IEP service coordinator shall have the following qualifications and be a:</text> <paragraph num="(a)"> <text>Professional who has a current license or certification, in accordance with §C(3) of this regulation, in the profession most immediately relevant to a participant's needs; or</text> </paragraph> <paragraph num="(b)"> <text>Nonprofessional who meets the requirements in §C(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A professional who is chosen as a participant's service coordinator shall meet the following licensing or certification requirements, as appropriate, and be:</text> <paragraph num="(a)"> <text>An audiologist licensed pursuant to COMAR 10.41.03.03 and certified pursuant to COMAR 13A.12.03.09;</text> </paragraph> <paragraph num="(b)"> <text>A guidance counselor with at least a master's degree and certified pursuant to COMAR 13A.12.03.02;</text> </paragraph> <paragraph num="(c)"> <text>A professional counselor licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>A registered nurse licensed pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>An occupational therapist licensed pursuant to Health Occupations Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>A physical therapist licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(g)"> <text>A psychologist with at least a master's degree in psychology and certified pursuant to COMAR 13A.12.03.08;</text> </paragraph> <paragraph num="(h)"> <text>A pupil personnel worker with at least a master's degree and certified pursuant to COMAR 13A.12.03.04;</text> </paragraph> <paragraph num="(i)"> <text>A social worker licensed at the master's level as a licensed certified social worker or licensed graduate social worker, pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(j)"> <text>A speech-language pathologist:</text> <paragraph num="(i)"> <text>With at least a master's degree in speech pathology; or</text> </paragraph> <paragraph num="(ii)"> <text>Certified pursuant to COMAR 13A.12.03.09 or licensed pursuant to Health Occupations Article, Title 2, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>An education professional who is:</text> <paragraph num="(i)"> <text>Certified as a teacher pursuant to COMAR 13A.12.02; or</text> </paragraph> <paragraph num="(ii)"> <text>Certified as an administrator or supervisor pursuant to COMAR 13A.12.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>A nonprofessional who is chosen as a participant’s IEP service coordinator shall meet the following requirements:</text> <paragraph num="(a)"> <text>Have at least a high school diploma or the equivalent;</text> </paragraph> <paragraph num="(b)"> <text>Have demonstrated training or experience in providing IEP service coordination to students with disabilities; and</text> </paragraph> <paragraph num="(c)"> <text>Participate in ongoing IEP service coordination training offerings as specified in the interagency plan for special education services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Conditions for Participation for Autism Waiver Service Coordination Providers."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a provider of Autism Waiver Service Coordination are that a provider shall:</text> <paragraph num="(1)"> <text>Be an agency within the State that employs or has under contract qualified personnel who convene or participate on waiver multidisciplinary teams as necessary, develop participant’s waiver plans of care, and provide service coordination services for waiver participants;</text> </paragraph> <paragraph num="(2)"> <text>Designate specific, qualified individuals as Autism Wavier service coordinators and verify their credentials for providing the services covered under this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Convene or participate on a waiver multidisciplinary team or teams for waiver participants, in accordance with the requirements of COMAR 10.09.56 and this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain a file on each participant that meets the Program’s requirements and includes the waiver participant’s:</text> <paragraph num="(a)"> <text>Technical eligibility form approved by MSDE, reviewed and signed at least annually;</text> </paragraph> <paragraph num="(b)"> <text>Determination of eligibility for level of care in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF/IID) — initial determination and redetermination, at least annually;</text> </paragraph> <paragraph num="(c)"> <text>Autism Waiver Risk Assessment pursuant to 10.09.56;</text> </paragraph> <paragraph num="(d)"> <text>Consent Form for Autism Waiver Services, signed before Autism Waiver enrollment and annually thereafter;</text> </paragraph> <paragraph num="(e)"> <text>Form for determination of Medicaid eligibility for Autism Waiver services — initial determination and redetermination, at least annually;</text> </paragraph> <paragraph num="(f)"> <text>Initial waiver plan of care, reviewed at least annually, and any plan revisions;</text> </paragraph> <paragraph num="(g)"> <text>Parental Rights and Responsibilities form reviewed and signed at least annually;</text> </paragraph> <paragraph num="(h)"> <text>Preauthorization by MSDE of any environmental accessibility adaptations reimbursed through the Autism Waiver, if applicable;</text> </paragraph> <paragraph num="(i)"> <text>Reportable Event forms concerning the waiver participant, if applicable;</text> </paragraph> <paragraph num="(j)"> <text>Record of ongoing Autism Wavier service coordination encounters, including:</text> <paragraph num="(i)"> <text>A description of the service;</text> </paragraph> <paragraph num="(ii)"> <text>The location of the service;</text> </paragraph> <paragraph num="(iii)"> <text>Date of contact and name of the parent/guardian or participant;</text> </paragraph> <paragraph num="(iv)"> <text>Type of contact;</text> </paragraph> <paragraph num="(v)"> <text>Supportive documentation of the service; and</text> </paragraph> <paragraph num="(vi)"> <text>The Autism Wavier service coordinator’s printed name and signature;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Monthly tracking logs with Technical Eligibility Exemption Request Forms as applicable; and</text> </paragraph> <paragraph num="(l)"> <text>A copy of the treatment plans for each applicable service provided or Reportable Event form, as applicable, if a treatment plan was not submitted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Autism Waiver Service Coordinator Requirements.</text> <paragraph num="(1)"> <text>An Autism Waiver service coordinator shall:</text> <paragraph num="(a)"> <text>Be employed by or under contract with a provider;</text> </paragraph> <paragraph num="(b)"> <text>Be approved by the participant’s parent or parents;</text> </paragraph> <paragraph num="(c)"> <text>Participate with the waiver multidisciplinary team in the development, or revision, of a participant’s waiver plan of care and in the waiver plan of care review;</text> </paragraph> <paragraph num="(d)"> <text>Assist the participant in gaining access to the services recommended in the waiver plan of care; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An Autism Waiver service coordinator who is chosen to provide services for a waiver participant shall have at least:</text> <paragraph num="(a)"> <text>1 year of relevant training or experience; and</text> </paragraph> <paragraph num="(b)"> <text>A bachelor’s degree.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An Autism Waiver service coordinator shall complete at least 5 hours of training on the Autism Waiver, offered by the Department and MSDE, prior to rendering Autism Waiver service coordination in accordance with Regulations .04-1 and .04-2 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Autism Waiver service coordinators shall attend one Statewide training for Autism Waiver service coordinators per fiscal year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program shall reimburse for the services in §§B—D of this regulation when the services have been documented, pursuant to the requirements of this chapter, as medically necessary.</text> </paragraph> <paragraph num="B."> <text>Initial IEP.</text> <paragraph num="(1)"> <text>Definition. “Unit of service” means:</text> <paragraph num="(a)"> <text>A completed initial IEP, signed by all members of the IEP team; and</text> </paragraph> <paragraph num="(b)"> <text>At least one contact by the participant’s service coordinator or IEP team in person or by telephone with the participant or the participant’s parent, on the participant’s behalf relating to development of the IEP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The covered services include convening and conducting an IEP team to:</text> <paragraph num="(a)"> <text>Perform a multidisciplinary assessment of the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Develop an initial IEP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Ongoing Service Coordination.</text> <paragraph num="(1)"> <text>Ongoing service coordination is provided by a participant's service coordinator.</text> </paragraph> <paragraph num="(2)"> <text>Definition. For purposes of this section, “unit of service” means:</text> <paragraph num="(a)"> <text>At least one contact per month by the service coordinator in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf relating to the child's ongoing service coordination; and</text> </paragraph> <paragraph num="(b)"> <text>The provision of all other necessary services covered under these regulations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>As necessary, the Program shall include as covered services the following:</text> <paragraph num="(a)"> <text>Acting as a central point of contact relating to IEP services for a participant;</text> </paragraph> <paragraph num="(b)"> <text>Maintaining contact with:</text> <paragraph num="(i)"> <text>The child's direct service providers, as applicable, which may include, but not be limited to, the child's Maryland Medicaid Managed Care Program provider or the Rare and Expensive case management provider; and</text> </paragraph> <paragraph num="(ii)"> <text>A participant and the participant's parent through home visits, office visits, written notes, school visits, telephone calls, and follow-up service as necessary;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Implementing the IEP by referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IEP, and providing linkage to agreed-upon direct service providers of services;</text> </paragraph> <paragraph num="(d)"> <text>Discussing with direct service providers the services needed and available for the participant, assessing the quality and quantity of services being provided, following up to identify any obstacles to a participant’s utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the services are being delivered in an integrated fashion as recommended in the IEP and meet the participant’s current needs;</text> </paragraph> <paragraph num="(e)"> <text>Providing a participant and the participant’s parent with information and direction that will assist them in successfully accessing and using the services recommended in the IEP;</text> </paragraph> <paragraph num="(f)"> <text>Informing a participant’s parent of the participant’s and the family’s rights and responsibilities in regard to specific programs and resources recommended in the IEP;</text> </paragraph> <paragraph num="(g)"> <text>Conducting, with a participant’s parent at a meeting or by other means acceptable to the parent and the service coordinator, a periodic review of the participant’s IEP every 6 months, or more frequently if warranted or the parent requests a review; and</text> </paragraph> <paragraph num="(h)"> <text>Reviewing at least annually at a meeting or by other means acceptable to the participant’s parent and others involved in the review process:</text> <paragraph num="(i)"> <text>The degree of a participant’s progress toward achieving the goals established in the IEP; and</text> </paragraph> <paragraph num="(ii)"> <text>Whether the goals or recommended services need to be revised.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Administrative, supervisory, and monitoring services associated with the ongoing service coordination, including coordinating with the child's primary care provider, are included as part of the service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>IEP Review.</text> <paragraph num="(1)"> <text>Definition. “Unit of service” means:</text> <paragraph num="(a)"> <text>A completed initial 60-day, interim, or annual IEP review as evidenced by a signed revised IEP or, if a revised IEP was not done, IEP team records documenting a meeting in which there is participation by at least two different disciplines; and</text> </paragraph> <paragraph num="(b)"> <text>At least one contact by the service coordinator or IEP team in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The covered services include convening and conducting an IEP team to:</text> <paragraph num="(a)"> <text>Perform a multidisciplinary reassessment of the participant's status and service needs; and</text> </paragraph> <paragraph num="(b)"> <text>Review and revise, as necessary, the participant’s IEP.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Covered Services — Autism Waiver Service Coordination — General Requirements."> <paragraph num="A."> <text>Autism Waiver Service Coordination is intended to:</text> <paragraph num="(1)"> <text>Assist a waiver participant in gaining access to the Autism Waiver services approved in the waiver participant's waiver plan of care;</text> </paragraph> <paragraph num="(2)"> <text>Assure coordination of the waiver participant's Autism Waiver services with other services received by the waiver participant; and</text> </paragraph> <paragraph num="(3)"> <text>Assure that the waiver participant's full range of needs are adequately met, so as to assure the individual's:</text> <paragraph num="(a)"> <text>Appropriate placement in the community;</text> </paragraph> <paragraph num="(b)"> <text>Health and safety;</text> </paragraph> <paragraph num="(c)"> <text>Quality of care; and</text> </paragraph> <paragraph num="(d)"> <text>Access to authorized, necessary services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver Service Coordinator. A waiver service coordinator employed by a provider shall assist with meeting the provider’s responsibilities specified in this regulation and Regulation .04-2 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Waiver Multidisciplinary Team. A waiver multidisciplinary team:</text> <paragraph num="(1)"> <text>Shall be convened by the local lead agency or local school system to:</text> <paragraph num="(a)"> <text>Assess or reassess a waiver applicant's or waiver participant's need and eligibility for Autism Waiver services; and</text> </paragraph> <paragraph num="(b)"> <text>Develop or review the waiver participant's waiver plan of care; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall include:</text> <paragraph num="(a)"> <text>The waiver participant's service coordinator;</text> </paragraph> <paragraph num="(b)"> <text>The waiver applicant's or waiver participant's parent or parents;</text> </paragraph> <paragraph num="(c)"> <text>A chairman who is the official representative of the local lead agency or local school system; and</text> </paragraph> <paragraph num="(d)"> <text>Other service providers and individuals, as appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Waiver Plan of Care.</text> <paragraph num="(1)"> <text>A waiver participant's waiver plan of care is:</text> <paragraph num="(a)"> <text>Initially developed on admission to the Autism Waiver;</text> </paragraph> <paragraph num="(b)"> <text>Reviewed at least every 12 months; and</text> </paragraph> <paragraph num="(c)"> <text>Revised as necessary by a waiver multidisciplinary team convened by the waiver participant's service coordinator.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A waiver participant’s waiver plan of care shall be submitted to MSDE before implementation.</text> </paragraph> <paragraph num="(3)"> <text>Any revisions or additions to a waiver participant’s waiver plan of care shall be submitted to MSDE before implementation.</text> </paragraph> <paragraph num="(4)"> <text>A waiver participant’s Autism Waiver service coordinator may make minor changes to the waiver participant’s waiver plan of care without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents, and MSDE is notified.</text> </paragraph> <paragraph num="(5)"> <text>A waiver participant’s initial or revised waiver plan of care shall include the:</text> <paragraph num="(a)"> <text>Identification of Autism Waiver service or services to be delivered;</text> </paragraph> <paragraph num="(b)"> <text>Service start date;</text> </paragraph> <paragraph num="(c)"> <text>Service stop date;</text> </paragraph> <paragraph num="(d)"> <text>Approved amount of services to be delivered; and</text> </paragraph> <paragraph num="(e)"> <text>Provider or providers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Three types of Autism Waiver Service Coordination shall be provided, at times concurrently;</text> <paragraph num="(1)"> <text>Waiver initial assessment;</text> </paragraph> <paragraph num="(2)"> <text>Waiver ongoing service coordination; and</text> </paragraph> <paragraph num="(3)"> <text>Waiver reassessment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-2" heading="Covered Services — Autism Waiver Service Coordination — Specific Requirements."> <paragraph num="A."> <text>Waiver Initial Assessment.</text> <paragraph num="(1)"> <text>Definition. For the purposes of this section, “unit of service” means:</text> <paragraph num="(a)"> <text>A completed initial waiver plan of care, submitted to MSDE and signed by the service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team; or</text> </paragraph> <paragraph num="(b)"> <text>The provision of all necessary services specified in §A(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The covered services shall include:</text> <paragraph num="(a)"> <text>Convening, coordinating, and participating on the waiver multidisciplinary team to perform the initial assessment and develop the waiver participant's initial waiver plan of care;</text> </paragraph> <paragraph num="(b)"> <text>Assisting the waiver participant or the parent or parents of a minor child with scheduling and attending the appointments required for the waiver initial assessment;</text> </paragraph> <paragraph num="(c)"> <text>Referring the waiver participant to approved Autism Waiver providers specified in the waiver plan of care;</text> </paragraph> <paragraph num="(d)"> <text>Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care;</text> </paragraph> <paragraph num="(e)"> <text>Assisting waiver participants with the waiver enrollment process specified in COMAR 10.09.56; and</text> </paragraph> <paragraph num="(f)"> <text>Assisting with completion of forms and coordinating with the Department for determination of the waiver participant's Medicaid financial and technical eligibility in a timely fashion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver Ongoing Autism Waiver Service Coordination.</text> <paragraph num="(1)"> <text>Definition. For the purposes of this section, a monthly “unit of service” means:</text> <paragraph num="(a)"> <text>At least one documented monthly contact by the waiver participant’s service coordinator in person, by telephone, via telehealth, or through written progress notes with the waiver participant or parent;</text> </paragraph> <paragraph num="(b)"> <text>A quarterly visit to the waiver participant’s residence, residential program, or day program conducted in person or via telehealth, including at least one in-person visit to the waiver participant’s residence every 12 months; and</text> </paragraph> <paragraph num="(c)"> <text>The provision of all other necessary services specified in §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The covered services shall include, as necessary:</text> <paragraph num="(a)"> <text>Acting as a central point of contact relating to a waiver participant;</text> </paragraph> <paragraph num="(b)"> <text>Coordinating Autism Waiver Service Coordination with the Department and MSDE;</text> </paragraph> <paragraph num="(c)"> <text>Referring the waiver participant to the Autism Waiver providers specified in the waiver plan of care;</text> </paragraph> <paragraph num="(d)"> <text>Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care according to the type, level, amount, frequency, and duration;</text> </paragraph> <paragraph num="(e)"> <text>Assisting with coordination of the Autism Waiver service delivery;</text> </paragraph> <paragraph num="(f)"> <text>Providing the waiver participant and the parent or parents with information and direction to assist them with accessing and successfully utilizing the Autism Waiver services preauthorized in the waiver plan of care;</text> </paragraph> <paragraph num="(g)"> <text>Maintaining contact with the waiver participant’s waiver and other service providers and with the waiver participant or parent through documented in-person visits, telehealth contact, telephone calls, mailings, and follow-up services as necessary;</text> </paragraph> <paragraph num="(h)"> <text>Following up to identify any problems or obstacles to the waiver participant's appropriate receipt of the Autism Waiver services specified in the waiver plan of care;</text> </paragraph> <paragraph num="(i)"> <text>Assisting to resolve any conflicts or crises in delivery of the waiver participant's Autism Waiver services which jeopardize the waiver participant's community placement or the health and safety of the waiver participant or another individual;</text> </paragraph> <paragraph num="(j)"> <text>Making minor changes to the waiver participant’s waiver plan of care as necessary, without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents and submitted to MSDE;</text> </paragraph> <paragraph num="(k)"> <text>Assuring that the necessary documentation is maintained in the waiver participant’s file, as specified in Regulation .03-1B(5) of this chapter;</text> </paragraph> <paragraph num="(l)"> <text>Providing MSDE with required information in the established time frame on waiver participants enrolled in the Autism Waiver; and</text> </paragraph> <paragraph num="(m)"> <text>Monitoring on an ongoing basis:</text> <paragraph num="(i)"> <text>The appropriateness of the type, amount, duration, and quality of the Autism Waiver services received by a waiver participant;</text> </paragraph> <paragraph num="(ii)"> <text>Whether a waiver participant's Autism Waiver services are delivered in an integrated and coordinated fashion and adequately meet the waiver participant's current needs; and</text> </paragraph> <paragraph num="(iii)"> <text>The impact of the Autism Waiver services on the waiver participant's health, safety, development, relationships with family members and other persons, home environment, educational program, quality of life, and life satisfaction.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Waiver Reassessment. For the purposes of this section, “unit of service” means:</text> <paragraph num="(1)"> <text>A completed waiver plan of care review at least every 12 months, with revisions as necessary, which is submitted to MSDE and signed by the Autism Waiver service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team;</text> </paragraph> <paragraph num="(2)"> <text>Assisting waiver participants with the waiver’s eligibility redetermination process, as specified in COMAR 10.09.56;</text> </paragraph> <paragraph num="(3)"> <text>Assisting families with making informed choices in selecting between a home and community-based waiver documented in the Autism Waiver Transitioning Youth Service Delivery Option Form or other documentation as required;</text> </paragraph> <paragraph num="(4)"> <text>Assisting the waiver participant or the parent or parents of a minor child with completion and submission of the application forms and accompanying documentation for the Medicaid financial and technical eligibility redetermination, in coordination with the Department, before the deadline established by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Completing a risk assessment within 45 days of receiving notification of eligibility by the Department using the Autism Waiver Risk Assessment form;</text> </paragraph> <paragraph num="(6)"> <text>Completing a risk assessment if the participant’s status changes, to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services; or</text> </paragraph> <paragraph num="(7)"> <text>Providing written notice to a MSDE representative of the participant’s ineligibility for the Autism Waiver.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Service Coordination for Children with an IEP or enrolled in the Autism Waiver is advisory in nature except for Autism Waiver Service Coordination, covered under Regulations .03-1, .04-1, and .04-2 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on a qualified participant’s option to receive the services covered under this chapter except that Autism Waiver Service Coordination, as defined by Regulations .03-1, .04-1, and .04-2 of this chapter, is required for waiver eligible persons who choose to enroll in the Autism Waiver.</text> </paragraph> <paragraph num="C."> <text>The services covered under this chapter may not restrict or otherwise affect the:</text> <paragraph num="(1)"> <text>Participant's eligibility for Title XIX benefits or other available benefits or programs except as limited by §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Freedom of the participant's parent to select from all available services for which the participant is found to be eligible;</text> </paragraph> <paragraph num="(3)"> <text>Participant's parent's free choice among qualified providers of services covered under this chapter, as well as among service providers of other services for which the participant qualifies; or</text> </paragraph> <paragraph num="(4)"> <text>Provider's right to bill the Program for other covered Program services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Service Coordination for Children with an IEP or enrolled in the Autism Waiver may not be:</text> <paragraph num="(1)"> <text>Provided as an integral and inseparable part of another covered Program service;</text> </paragraph> <paragraph num="(2)"> <text>Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan; or</text> </paragraph> <paragraph num="(3)"> <text>Delivered as part of institutional discharge planning.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement may not be made for the services covered under this chapter if the participant is receiving a similar case management service under another Program authority.</text> </paragraph> <paragraph num="F."> <text>Reimbursement may not be made to providers that participate on, but do not convene, an IEP team or teams, for ongoing service coordination for residential students who reside in facilities that receive Medical Assistance reimbursement for residential services.</text> </paragraph> <paragraph num="G."> <text>Only waiver participants may receive Autism Waiver Service Coordination, covered under Regulations .04-1 and .04-2 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider shall submit requests for payment for the services covered under this chapter according to procedures established by the Program. The Program reserves the right to return to the provider, before payment, all requests not properly completed.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall:</text> <paragraph num="(a)"> <text>Bill the Program for the appropriate fee or fees specified in §C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party; and</text> </paragraph> <paragraph num="(c)"> <text>Submit a request for payment in the manner specified by the Program, that includes the:</text> <paragraph num="(i)"> <text>Date or dates of service,</text> </paragraph> <paragraph num="(ii)"> <text>Participant's name and Medical Assistance number,</text> </paragraph> <paragraph num="(iii)"> <text>Provider’s name, location, and Medicaid provider number; and</text> </paragraph> <paragraph num="(iv)"> <text>Nature, unit or units, and procedure code or codes of covered services provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providers that convene or conduct an IEP team or teams in accordance with COMAR 13A.05.01 may bill the Program for all IEP-related services contained in this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Providers that participate on, but do not convene or conduct, an IEP team or teams, may only bill for ongoing service coordination, only for day students. These providers may not bill for ongoing service coordination for the residential students who reside in facilities that receive Medical Assistance reimbursement for residential services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>The Program shall make payment only to one qualified provider for covered services rendered on a particular date of service to a participant and according to the following fee schedule covered under this chapter:</text> <paragraph num="(1)"> <text>Initial IEP: no more than one unit of service may be reimbursed per participant ... $500;</text> </paragraph> <paragraph num="(2)"> <text>Ongoing IEP service coordination: no more than one unit of service per month may be reimbursed for a participant ... $150;</text> </paragraph> <paragraph num="(3)"> <text>IEP review: at most, three units of service may be reimbursed for a participant in a 12-month period ... $275;</text> </paragraph> <paragraph num="(4)"> <text>Waiver initial assessment: No more than one unit of service may be reimbursed per waiver participant ... $500;</text> </paragraph> <paragraph num="(5)"> <text>Waiver ongoing service coordination: No more than one unit of service per month may be reimbursed for a waiver participant ... $150;</text> </paragraph> <paragraph num="(6)"> <text>Waiver reassessment: At most, four units of service may be reimbursed for a waiver participant in a 12-month period ... $275.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program may not make payment for ongoing service coordination when, for the same month, payment is made to the provider for furnishing to the participant:</text> <paragraph num="(1)"> <text>An initial IEP service; or</text> </paragraph> <paragraph num="(2)"> <text>An IEP review service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Program may not make payment for more than one IEP review in the same month, unless a subsequent review is documented as an emergency.</text> </paragraph> <paragraph num="F."> <text>The Program may not make payment for an initial IEP and an IEP review in the same month, unless a review is documented as an emergency.</text> </paragraph> <paragraph num="G."> <text>If an IEP review takes more than one meeting to complete, the Program shall only make payment for the meeting during which the review was signed.</text> </paragraph> <paragraph num="H."> <text>A provider shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider's usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The rate established under §C of this regulation</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations are interpreted in accordance with COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective June 17, 1993 (20:14 Md. R. 1165); adopted permanently effective September 27, 1993 (20:19 Md. R. 1472)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective March 23, 1998 (25:8 Md. R. 595); amended permanently effective June 29, 1998 (25:13 Md. R. 993):</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended effective July 1, 2001(28:12 Md. R. 1107)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); March 28, 2016 (43:6 Md. R. 407): November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 2002 (30:1 Md. R. 23); amended permanently effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04-1 and .04-2 adopted effective July 1, 2001(28:12 Md. R. 1107)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04-1 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1D amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2C amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> </annotations> </chapter> <chapter num="53" heading="Early and Periodic Screening, Diagnosis, and Treatment: Nursing Services for Individuals Younger than 21 Years Old"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Caregiver” means a willing and able individual who is trained in providing care to the participant.</text> </paragraph> <paragraph num="(2)"> <text>“Certified medication technician (CMT)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Board under COMAR 10.39.04; and</text> </paragraph> <paragraph num="(c)"> <text>Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and</text> </paragraph> <paragraph num="(b)"> <text>Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Delegated nursing services” has the meaning stated in COMAR 10.27.11.</text> </paragraph> <paragraph num="(5)"> <text>Employment.</text> <paragraph num="(a)"> <text>“Employment” means the condition of having paid work.</text> </paragraph> <paragraph num="(b)"> <text>“Employment” includes job training or classes required to obtain government licensure or certification to engage in an occupation or profession, and work to fulfill requirements to obtain Temporary Cash Assistance or other public benefits.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Department” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(7)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance recipients under 21 years old.</text> </paragraph> <paragraph num="(8)"> <text>“Electronic visit verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2.</text> </paragraph> <paragraph num="(9)"> <text>“Emergency medical condition” means a health condition manifested by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent lay individual possessing an average knowledge of health and medicine to result in:</text> <paragraph num="(a)"> <text>Placing health in jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions;</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part; or</text> </paragraph> <paragraph num="(d)"> <text>Development or continuance of severe pain.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Emergency service” means a service or care rendered to a recipient exhibiting an emergency medical condition as defined in §B(3) of this regulation.</text> </paragraph> <paragraph num="(11)"> <text>“EPSDT screen” means the complete package of various health screening procedures, required by the State periodicity schedule, or a partial screen, that an EPSDT participant receives.</text> </paragraph> <paragraph num="(12)"> <text>“Home” means the place of residence, occupied by the recipient, other than a residence or facility where private duty nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment.</text> </paragraph> <paragraph num="(13)"> <text>“Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10.</text> </paragraph> <paragraph num="(14)"> <text>"Home health aide (HHA)” means an individual, regardless of title, who meets all the conditions of participation specified in:</text> <paragraph num="(a)"> <text>42 CFR §484.36; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(16)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(17)"> <text>“Nurse” means a person who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(18)"> <text>“Nursing care plan” means a plan developed by a registered nurse that identifies the patient's diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient's medical condition.</text> </paragraph> <paragraph num="(19)"> <text>“Participant” means a recipient who is eligible for and receiving services in accordance with the provisions of this chapter.</text> </paragraph> <paragraph num="(20)"> <text>“Plan of care” means an individualized care plan, written in collaboration with the participant or family, including the plan developed under COMAR 10.09.27 and 10.09.69, which outlines a plan of action to meet the goals or expected outcomes for the participant.</text> </paragraph> <paragraph num="(21)"> <text>“Preauthorization” means the approval required from the Department or its designee before services may be rendered.</text> </paragraph> <paragraph num="(22)"> <text>“Primary medical provider (PMP)” means the medical provider who functions as the principal medical provider to the participant including a physician, certified nurse midwife, or nurse practitioner.</text> </paragraph> <paragraph num="(23)"> <text>“Private duty nursing services” means skilled nursing services for recipients who require more individual and continuous care than is available under the home health program, and which are provided by a registered nurse or a licensed practical nurse, in a recipient's own home or another setting when normal life activities take the recipient outside his or her home.</text> </paragraph> <paragraph num="(24)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(25)"> <text>“Progress note” means a signed and dated written notation by the home care nurse which:</text> <paragraph num="(a)"> <text>Summarizes facts about the care given and the participant's responses during a given period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specifically addresses the established goals of treatment;</text> </paragraph> <paragraph num="(c)"> <text>Is consistent with the participant's plan of care; and</text> </paragraph> <paragraph num="(d)"> <text>Is written during the course of care.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Provider” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(27)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(28)"> <text>“Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05.</text> </paragraph> <paragraph num="(29)"> <text>“School” means courses or classes for the acquisition of a General Education Diploma, high school diploma, associate's degree, or a first-time bachelor's degree.</text> </paragraph> <paragraph num="(30)"> <text>“Supervision” means authoritative, procedural guidance by a licensed registered nurse for the accomplishment of a function or activity, as well as the process of critical watching, directing, and evaluating another's performance.</text> </paragraph> <paragraph num="(31)"> <text>“Urgent service” means a service or care for a medical condition that is manifested by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent lay individual who possesses an average knowledge of health and medicine, to result in an emergency medical condition.</text> </paragraph> <paragraph num="(32)"> <text>“Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing Requirements."> <paragraph num="A."> <text>Nurses rendering or supervising the provision of private duty nursing services shall be licensed in accordance with licensing requirements specified in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>An agency providing services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the agency is providing services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <text>Requirements for participation for nursing services are that a provider shall:</text> <paragraph num="A."> <text>Meet the general Medical Assistance provider requirements as specified in COMAR 10.09.36.03;</text> </paragraph> <paragraph num="B."> <text>Be licensed as a:</text> <paragraph num="(1)"> <text>Residential service agency under COMAR 10.07.05; or</text> </paragraph> <paragraph num="(2)"> <text>Home health agency under COMAR 10.07.10;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Have on staff at least one registered nurse supervisor who:</text> <paragraph num="(1)"> <text>Provides and documents initial direction to the participant's caregivers and assigned nurse, CNA, or HHA regarding the provision of nursing services to the participant;</text> </paragraph> <paragraph num="(2)"> <text>Documents that each assigned nurse, CNA, or HHA providing home care services has the necessary skills to meet the participant's needs including knowledge of any medical equipment in use by the participant;</text> </paragraph> <paragraph num="(3)"> <text>Conducts and documents a monthly review of the progress notes to assure adequacy and quality of care;</text> </paragraph> <paragraph num="(4)"> <text>Makes supervisory visits in the participant's home or another site where the participant is receiving nursing services and regularly evaluates the assigned nurse’s performance of the nursing services in accordance with COMAR 10.27.09 and 10.27.10;</text> </paragraph> <paragraph num="(5)"> <text>Makes supervisory visits in the participant's home or another site where the participant is receiving CNA or HHA services and regularly evaluates their performance of the delegated nursing tasks in accordance with COMAR 10.27.11;</text> </paragraph> <paragraph num="(6)"> <text>Completes a note after each supervisory visit that becomes part of the participant's file;</text> </paragraph> <paragraph num="(7)"> <text>Provides and documents training to the participant's caregiver or caregivers and the individual or individuals providing backup to the caregiver or caregivers; and</text> </paragraph> <paragraph num="(8)"> <text>Develops an initial nursing care plan which is reevaluated 30 days after the initial assessment and modified as necessary to meet the participant's nursing needs;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ensure that each nurse, CNA, or HHA rendering services to a participant:</text> <paragraph num="(1)"> <text>Has a valid, nontemporary, nursing license or certification to provide nursing, CNA, or HHA services in the jurisdiction in which services are rendered;</text> </paragraph> <paragraph num="(2)"> <text>Has completed a skills checklist and demonstration of competency on an annual basis that was observed, documented, and verified by the signature of the RN supervisor or an RN designated by the supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrates to the provider's nurse supervisor sufficient specialized training and experience to deliver the level of service required by each participant to whom the nurse, CNA, or HHA renders direct care;</text> </paragraph> <paragraph num="(4)"> <text>Demonstrates to the provider's nurse supervisor, on a continuing basis, the ability to carry out competently the services specified in a participant's care plan, subject to review by the Department or its designee;</text> </paragraph> <paragraph num="(5)"> <text>Participates in the multidisciplinary team process, if appropriate, including attending team meetings, for children receiving home and community-based services under COMAR 10.09.27, and renders services in accordance with the plan of care recommended by the team and approved by the Department or its designee, including any subsequent revisions to that plan;</text> </paragraph> <paragraph num="(6)"> <text>Is currently certified in cardiopulmonary resuscitation (CPR) at the time services are rendered;</text> </paragraph> <paragraph num="(7)"> <text>Provides care and services in accordance with generally accepted nursing practices;</text> </paragraph> <paragraph num="(8)"> <text>Knows how to contact the provider and the registered nurse supervisor;</text> </paragraph> <paragraph num="(9)"> <text>Provides care according to the provider's policies for the delivery of services to participants as described in §E of this regulation;</text> </paragraph> <paragraph num="(10)"> <text>Has not been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to a felony of any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; and</text> </paragraph> <paragraph num="(11)"> <text>If a CNA or HHA, has completed the training and been certified by the Maryland Board of Nursing as a CMT;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Develop policies for the delivery of services to participants, including policies on the following:</text> <paragraph num="(1)"> <text>Skill assessments;</text> </paragraph> <paragraph num="(2)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(3)"> <text>Administration of drugs, including controlled substances;</text> </paragraph> <paragraph num="(4)"> <text>Clinical record maintenance;</text> </paragraph> <paragraph num="(5)"> <text>Job description and educational qualifications of all staff members;</text> </paragraph> <paragraph num="(6)"> <text>Clinical management;</text> </paragraph> <paragraph num="(7)"> <text>Infection control procedures;</text> </paragraph> <paragraph num="(8)"> <text>Disposal of biomedical waste;</text> </paragraph> <paragraph num="(9)"> <text>Maintenance of equipment;</text> </paragraph> <paragraph num="(10)"> <text>Supervision, including appropriate frequencies of direct supervision;</text> </paragraph> <paragraph num="(11)"> <text>Staffing and scheduling, including contingency plans for care of the participant in the absence of the caregiver, assigned nurse, CNA, or HHA;</text> </paragraph> <paragraph num="(12)"> <text>A quality assurance program;</text> </paragraph> <paragraph num="(13)"> <text>Procedures for resolution of complaints; and</text> </paragraph> <paragraph num="(14)"> <text>Coordination of care, when appropriate, including:</text> <paragraph num="(a)"> <text>Delineation of service responsibilities when other service providers are involved in a participant's care;</text> </paragraph> <paragraph num="(b)"> <text>Notification to participants of each service provider's responsibilities in these instances; and</text> </paragraph> <paragraph num="(c)"> <text>Development of a discharge plan when the participant, the participant's legal representative, or the provider terminates care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Conduct a reference check on each nurse, CNA, or HHA rendering care to a participant consisting of:</text> <paragraph num="(1)"> <text>A documented face-to-face interview between agency representatives and the nurse, CNA, or HHA;</text> </paragraph> <paragraph num="(2)"> <text>Documented efforts at verification of past employment history; and</text> </paragraph> <paragraph num="(3)"> <text>A criminal background check to include, when caring for a child, an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Maintain a personnel folder at the agency's business office for each nurse, CNA, and HHA which shall include the following:</text> <paragraph num="(1)"> <text>Verification of current nursing license or certification;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the current CPR certification;</text> </paragraph> <paragraph num="(3)"> <text>Documentation related to:</text> <paragraph num="(a)"> <text>The face-to-face interview;</text> </paragraph> <paragraph num="(b)"> <text>Verification that any nurse who serves a participant younger than 19 years old has past employment which shall include at least 1 year of clinical experience which includes pediatric direct patient care within the last 3 years; and</text> </paragraph> <paragraph num="(c)"> <text>Verification of the CNA or HHA’s past employment which shall include at least 1 year of clinical experience within the last 3 years;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Written verification of a criminal background check; and</text> </paragraph> <paragraph num="(5)"> <text>Documentation of a completed skills checklist signed and dated by the registered nurse supervisor or the registered nurse supervisor designee and the assigned nurse, CNA, or HHA;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Provide the participant or the participant's caregiver with the following written information:</text> <paragraph num="(1)"> <text>Name and phone number of the provider's contact person; and</text> </paragraph> <paragraph num="(2)"> <text>Name of each nurse, CNA, or HHA assigned by the provider to render services to the participant;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Provide a mechanism for the timely investigation of written complaints such that:</text> <paragraph num="(1)"> <text>Disruption of service does not result from the filing of a complaint;</text> </paragraph> <paragraph num="(2)"> <text>Complete files are maintained on the source, category, and disposition of the complaint;</text> </paragraph> <paragraph num="(3)"> <text>A summary report of the complaint investigation is made available to the Department or the Department's designee;</text> </paragraph> <paragraph num="(4)"> <text>A summary report of the complaint investigation is made available for public inspection, upon request; and</text> </paragraph> <paragraph num="(5)"> <text>When a complaint investigation is not conducted, reasons are documented and forwarded with the complaint to the Department or the Department's designee;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Provide back-up services when the assigned nurse, CNA, or HHA is unable to provide the services;</text> </paragraph> <paragraph num="K."> <text>Ensure a nurse, CNA, or HHA is not scheduled to work for more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="L."> <text>Demonstrate on a continuing basis the capacity to provide services to participants in the amount and level required in the participant's care plan including the development of a contingency plan to assure coverage;</text> </paragraph> <paragraph num="M."> <text>Provide the participant or the participant's representative with:</text> <paragraph num="(1)"> <text>At least 14 days written notice of termination of services when it is the provider's decision to terminate and the medical condition remains unchanged; and</text> </paragraph> <paragraph num="(2)"> <text>A copy of a developed discharge plan if the participant, the participant's representative, or the provider elects to discontinue the provider's services to the participant;</text> </paragraph> </paragraph> <paragraph num="N."> <text>Ensure that each nurse, CNA, or HHA rendering services to a participant:</text> <paragraph num="(1)"> <text>Completes a progress note for each shift which becomes part of the participant's permanent record;</text> </paragraph> <paragraph num="(2)"> <text>Is providing services which follow the participant's care plan; and</text> </paragraph> <paragraph num="(3)"> <text>Is providing services ordered by the participant's primary medical provider before the start of care and renewed every 60 days as indicated by the participant’s primary medical provider’s signed and dated orders;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Maintain sufficient documentation to demonstrate that the requirements of this chapter are met.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program shall cover services rendered by a nurse, CNA, or HHA when the:</text> <paragraph num="(1)"> <text>Services are ordered by the participant's primary medical provider and renewed every 60 days after that;</text> </paragraph> <paragraph num="(2)"> <text>Services are directly related to the plan of care;</text> </paragraph> <paragraph num="(3)"> <text>Services are described in the nursing care plan and progress notes;</text> </paragraph> <paragraph num="(4)"> <text>Services are of a scope that is more individual and continuous than what is available under the home health program;</text> </paragraph> <paragraph num="(5)"> <text>Services are delivered in the recipient's home, or other setting when normal life activities take the recipient outside the home;</text> </paragraph> <paragraph num="(6)"> <text>Services include supervision of family caregivers in the home while family caregivers practice the skills necessary to provide care to the recipient in accordance with the established plan of care;</text> </paragraph> <paragraph num="(7)"> <text>Services are preauthorized in accordance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Services are received by the participant as documented by the signature of the participant or the participant’s representative on the nursing provider’s official form;</text> </paragraph> <paragraph num="(9)"> <text>Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver;</text> </paragraph> <paragraph num="(10)"> <text>Participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available;</text> </paragraph> <paragraph num="(11)"> <text>Caregiver provides documentation of each of the following when applicable:</text> <paragraph num="(a)"> <text>The caregiver’s work schedule along with commuting times;</text> </paragraph> <paragraph num="(b)"> <text>The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and</text> </paragraph> <paragraph num="(c)"> <text>Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Services are provided only in the absence of the willing and able caregiver during sleeping hours and during the times documented in §A(11) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall cover nursing services rendered by a registered nurse when:</text> <paragraph num="(1)"> <text>The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a registered nurse in accordance with COMAR 10.27.09 and the services cannot be:</text> <paragraph num="(a)"> <text>Performed by a licensed practical nurse in accordance with COMAR 10.27.10; and</text> </paragraph> <paragraph num="(b)"> <text>Delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland and in accordance with COMAR 10.27.11;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Sufficient documentation is maintained by the registered nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and</text> </paragraph> <paragraph num="(4)"> <text>Services are preauthorized by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall cover nursing services rendered by a licensed practical nurse when:</text> <paragraph num="(1)"> <text>The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a licensed practical nurse in accordance with COMAR 10.27.10 and the services:</text> <paragraph num="(a)"> <text>Do not require the knowledge and skills of a registered nurse in accordance with COMAR 10.27.09; and</text> </paragraph> <paragraph num="(b)"> <text>Cannot be delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Sufficient documentation is maintained by the licensed practical nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and</text> </paragraph> <paragraph num="(4)"> <text>Services are preauthorized by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program shall cover delegated nursing services provided by a CNA or HHA who is also certified as a CMT when:</text> <paragraph num="(1)"> <text>The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the CNA or HHA for at least 2 or more continuous hours;</text> </paragraph> <paragraph num="(2)"> <text>The services provided include but are not limited to:</text> <paragraph num="(a)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or</text> </paragraph> <paragraph num="(b)"> <text>Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Sufficient documentation is maintained by the CNA or HHA including signed and dated progress notes which are reviewed by the nurse supervisor; and</text> </paragraph> <paragraph num="(4)"> <text>Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Program shall cover a provider's initial assessment of a participant's medical need for services when the assessment:</text> <paragraph num="(1)"> <text>Is 3 hours or less;</text> </paragraph> <paragraph num="(2)"> <text>Does not require preauthorization;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrates:</text> <paragraph num="(a)"> <text>A comprehensive assessment of the recipient's health status;</text> </paragraph> <paragraph num="(b)"> <text>An assessment of the need for services;</text> </paragraph> <paragraph num="(c)"> <text>An assessment of the scope and duration of services to be provided;</text> </paragraph> <paragraph num="(d)"> <text>An assessment of the recipient's residence; and</text> </paragraph> <paragraph num="(e)"> <text>Consultation with the primary medical provider, and a multidisciplinary team if the participant is receiving services under COMAR 10.09.27, to confirm the need for services and to develop a plan of care; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is conducted by a licensed registered nurse.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If a need for services is confirmed during a participant's initial assessment, the registered nurse, in conjunction with the participant's primary medical provider, shall develop a care plan. When a participant also receives services under COMAR 10.09.27, the nurse or registered nurse supervisor shall participate as a member of the multi-disciplinary team and recommend a plan of care. The care plan shall be reviewed and updated to reflect the current service orders and shall include:</text> <paragraph num="(1)"> <text>Prognosis;</text> </paragraph> <paragraph num="(2)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(3)"> <text>Treatment;</text> </paragraph> <paragraph num="(4)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(5)"> <text>Services required, including specific nursing procedures;</text> </paragraph> <paragraph num="(6)"> <text>Frequency of visits (that is, hours of nursing care ordered for each day);</text> </paragraph> <paragraph num="(7)"> <text>Duration of treatment;</text> </paragraph> <paragraph num="(8)"> <text>Functional limitations;</text> </paragraph> <paragraph num="(9)"> <text>Permitted and prohibited activities;</text> </paragraph> <paragraph num="(10)"> <text>Diet;</text> </paragraph> <paragraph num="(11)"> <text>Medications;</text> </paragraph> <paragraph num="(12)"> <text>Mental status;</text> </paragraph> <paragraph num="(13)"> <text>A list of medical supplies related to each nursing procedure and how these are to be used in the participant's care:</text> </paragraph> <paragraph num="(14)"> <text>A list of durable medical equipment related to each nursing procedure and how the equipment is to be used in the participant's care;</text> </paragraph> <paragraph num="(15)"> <text>Safety measures to protect against injury;</text> </paragraph> <paragraph num="(16)"> <text>Emergency plan;</text> </paragraph> <paragraph num="(17)"> <text>Contingency plan for back-up coverage;</text> </paragraph> <paragraph num="(18)"> <text>Nurse's role in including the family in the provision of care;</text> </paragraph> <paragraph num="(19)"> <text>Plan to decrease services when the participant's condition improves or as the caregivers become better able to meet the participant's needs; and</text> </paragraph> <paragraph num="(20)"> <text>Other appropriate items.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department may preauthorize on a short-term basis services for assessment purposes only, when medical information is insufficient to determine medical necessity;</text> </paragraph> <paragraph num="H."> <text>Services shall be decreased as the caregivers become better able to meet the participant's needs.</text> </paragraph> <paragraph num="I."> <text>The Program shall cover nursing services ordered by the participant's primary medical provider when the primary medical provider is an individual who is enrolled as a provider in the Program with an active status on the date of service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Under this chapter, the Program does not cover the following:</text> <paragraph num="(1)"> <text>Home health services that are covered under COMAR 10.09.04;</text> </paragraph> <paragraph num="(2)"> <text>Services rendered by a nurse, CNA, or HHA who is a member of the participant's immediate family or who ordinarily resides with the participant;</text> </paragraph> <paragraph num="(3)"> <text>Custodial services;</text> </paragraph> <paragraph num="(4)"> <text>Services not deemed medically necessary at the initial assessment or the most recent plan of care review;</text> </paragraph> <paragraph num="(5)"> <text>Services delivered by a nurse, CNA, or HHA who is not directly supervised by a registered nurse who documents all supervisory visits and activities;</text> </paragraph> <paragraph num="(6)"> <text>Services not preauthorized by the Department or the Department's designee, with the exception of the initial assessment;</text> </paragraph> <paragraph num="(7)"> <text>Services provided to a participant in a hospital, residential treatment center, or an intermediate care facility for individuals with intellectual disabilities or a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment;</text> </paragraph> <paragraph num="(8)"> <text>Services not directly related to the plan of care;</text> </paragraph> <paragraph num="(9)"> <text>Services specified in the plan of care, when the plan of care has not been signed by the recipient or the recipient's legally authorized representative, the Department or the Department's designee, and the recipient's primary medical provider, when the services are covered under COMAR 10.09.27;</text> </paragraph> <paragraph num="(10)"> <text>Services described in the plan of care whenever a major change occurs in the recipient's medical condition or skilled nursing care needs;</text> </paragraph> <paragraph num="(11)"> <text>Services not ordered by the recipient's primary medical provider as a result of a partial or complete EPSDT screen;</text> </paragraph> <paragraph num="(12)"> <text>Services specified in Regulation .04 of this chapter which duplicate or supplant services rendered by the recipient's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or program services that the recipient receives or is eligible to receive;</text> </paragraph> <paragraph num="(13)"> <text>Services specified in Regulation .04 of this chapter to recipients eligible for any third-party liability coverage of those services;</text> </paragraph> <paragraph num="(14)"> <text>Services provided for the convenience or preference of the recipient or the primary caregiver rather than as required by the recipient's medical condition;</text> </paragraph> <paragraph num="(15)"> <text>Services which are not initially ordered before the start of care and renewed every 60 days by the participant's primary medical provider;</text> </paragraph> <paragraph num="(16)"> <text>Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which services are rendered;</text> </paragraph> <paragraph num="(17)"> <text>Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered;</text> </paragraph> <paragraph num="(18)"> <text>Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11;</text> </paragraph> <paragraph num="(19)"> <text>Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff's home;</text> </paragraph> <paragraph num="(20)"> <text>Services not documented; and</text> </paragraph> <paragraph num="(21)"> <text>Respite services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall only cover one-to-one nursing when a participant's condition requires that level of service and shared services are not an option.</text> </paragraph> <paragraph num="C."> <text>Nursing services may only be provided to EPSDT eligible individuals under 21 years old.</text> </paragraph> <paragraph num="D."> <text>The Program does not cover nursing services ordered by an:</text> <paragraph num="(1)"> <text>Individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>Entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements."> <paragraph num="A."> <text>The Department or the Department's designee shall preauthorize nursing services, according to medical necessity, frequency, and duration, as a prerequisite to payment beyond the initial assessment.</text> </paragraph> <paragraph num="B."> <text>Preauthorization is issued when:</text> <paragraph num="(1)"> <text>Program procedures are met;</text> </paragraph> <paragraph num="(2)"> <text>Program limitations are met;</text> </paragraph> <paragraph num="(3)"> <text>The requirements specified in this chapter are met; and</text> </paragraph> <paragraph num="(4)"> <text>The Department or the Department's designee determines that the services are medically necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall request the Department or the Department's designee to authorize the initiation or continuance of nursing services before the initiation or continuation of services unless services are rendered to a participant in need of emergency or urgent medical services.</text> </paragraph> <paragraph num="D."> <text>The provider shall request the Department or the Department's designee to authorize emergency or urgent medical services rendered to a recipient not later than the close of business the next business day after the emergency or urgent service is rendered.</text> </paragraph> <paragraph num="E."> <text>If nursing services in excess of the initial authorized amount are necessary, then:</text> <paragraph num="(1)"> <text>The assigned nurse or registered nurse supervisor shall contact the primary medical provider for approval of additional hours; and</text> </paragraph> <paragraph num="(2)"> <text>The provider shall request the Department or the Department's designee to authorize the increase in services before the initiation of change for nonemergency and nonurgent changes and not later than the close of business the next business day after the emergency or urgent service is rendered.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An existing preauthorization shall remain in effect when a recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours and there is no substantive change in the recipient's plan of care requiring a change in the number of authorized units of nursing services.</text> </paragraph> <paragraph num="G."> <text>Since preauthorization does not guarantee Program eligibility, the provider is responsible for checking for Program eligibility on the date of service.</text> </paragraph> <paragraph num="H."> <text>Preauthorization is only valid for services initiated within the period authorized by the Department or the Department's designee.</text> </paragraph> <paragraph num="I."> <text>Preauthorization is only valid for services rendered over a fixed period of time, such as:</text> <paragraph num="(1)"> <text>The periods designated for recipients who are served under COMAR 10.09.27;</text> </paragraph> <paragraph num="(2)"> <text>For the designated time initially ordered by the recipient's primary care provider, up to 30 days; and</text> </paragraph> <paragraph num="(3)"> <text>For intervals of 60 days after that or as considered necessary by the Department or the Department's designee.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Authorization shall be rescinded by the Department or the Department's designee when:</text> <paragraph num="(1)"> <text>The recipient is terminated from care;</text> </paragraph> <paragraph num="(2)"> <text>The participant is admitted to a residential treatment center, an intermediate care facility for individuals with intellectual disabilities, or a nursing facility;</text> </paragraph> <paragraph num="(3)"> <text>The recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours resulting in a change in the recipient's plan of care;</text> </paragraph> <paragraph num="(4)"> <text>The recipient is admitted to a hospital for a period of more than 72 consecutive hours; or</text> </paragraph> <paragraph num="(5)"> <text>The Department or the Department's designee determines that the care is no longer medically necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures are as set forth in COMAR 10.09.36.04 and .06.</text> </paragraph> <paragraph num="B."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the electronic visit verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2.</text> </paragraph> <paragraph num="(3)"> <text>Providers shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established according to the fee schedule published by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Rates.</text> <paragraph num="(1)"> <text>Effective July 1, 2022, through December 31, 2023, rates for the services outlined in this regulation shall be as follows:</text> <paragraph num="(a)"> <text>$17.87 for 15 minutes of services provided by a registered nurse to one participant;</text> </paragraph> <paragraph num="(b)"> <text>$12.32 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(c)"> <text>$11.58 for 15 minutes of services provided by a licensed practical nurse to one participant;</text> </paragraph> <paragraph num="(d)"> <text>$7.99 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(e)"> <text>$6.12 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant;</text> </paragraph> <paragraph num="(f)"> <text>$4.22 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(g)"> <text>$5.08 for 15 minutes of services provided by a CNA or HHA to one participant;</text> </paragraph> <paragraph num="(h)"> <text>$3.50 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and</text> </paragraph> <paragraph num="(i)"> <text>A flat rate of $71.41 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective January 1, 2024 through June 30, 2024, rates for the services outlined in this regulation shall be as follows:</text> <paragraph num="(a)"> <text>$19.2951 for 15 minutes of services provided by a registered nurse to one participant;</text> </paragraph> <paragraph num="(b)"> <text>$13.3101 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(c)"> <text>$12.5061 for 15 minutes of services provided by a licensed practical nurse to one participant;</text> </paragraph> <paragraph num="(d)"> <text>$8.6266 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(e)"> <text>$6.6105 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant;</text> </paragraph> <paragraph num="(f)"> <text>$4.5611 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(g)"> <text>$5.4874 for 15 minutes of services provided by a CNA or HHA to one participant;</text> </paragraph> <paragraph num="(h)"> <text>$3.7848 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and</text> </paragraph> <paragraph num="(i)"> <text>A flat rate of $77.13 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective July 1, 2024, rates for the services outlined in this regulation shall be as follows:</text> <paragraph num="(a)"> <text>$19.8739 for 15 minutes of services provided by a registered nurse to one participant;</text> </paragraph> <paragraph num="(b)"> <text>$13.7094 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(c)"> <text>$12.8813 for 15 minutes of services provided by a licensed practical nurse to one participant;</text> </paragraph> <paragraph num="(d)"> <text>$8.8854 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(e)"> <text>$6.8088 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant;</text> </paragraph> <paragraph num="(f)"> <text>$4.6979 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence;</text> </paragraph> <paragraph num="(g)"> <text>$5.6520 for 15 minutes of services provided by a CNA or HHA to one participant;</text> </paragraph> <paragraph num="(h)"> <text>$3.8983 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and</text> </paragraph> <paragraph num="(i)"> <text>A flat rate of $79.44 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Program’s rates as specified in this regulation shall adjust each year, subject to the limitations of the State budget.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The nursing services provider shall identify the individual who ordered the nursing services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are those set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective May 5, 1993 (20:11 Md. R. 911); adopted permanently effective August 2, 1993 (20:15 Md. R. 1220)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03—.07 amended as an emergency provision effective June 1, 1994 (21:13 Md. R. 1152); amended permanently effective September 26, 1994 (21:19 Md. R. 1635)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .03—.06 amended as an emergency provision effective January 1, 1997 (23:26 Md. R. 1856); amended permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); August 27, 2007 (34:17 Md. R. 1507); March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379); August 21, 2023 (50:16 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 31, 2005 (32:2 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, H amended effective August 23, 1999 (26:17 Md. R. 1323)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, G amended effective March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04I adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 1, 2014 (41:6 Md. R. 379); June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C repealed effective March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 3, 2006 (33:13 Md. R. 1064); October 31, 2011 (38:22 Md. R. 1345); April 1, 2014 (41:6 Md. R. 379); October 24, 2016 (43:21 Md. R. 1166); May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended as an emergency provision effective January 1, 2000 (27:2 Md. R. 140); amended permanently effective May 1, 2000 (27:8 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective April 6, 2009 (36:7 Md. R. 524); August 21, 2023 (50:16 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 995); August 21, 2023 (50:16 Md. R. 726); May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1347); amended permanently effective September 24, 2007 (34:19 Md. R. 1650)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E repealed effective March 10, 2008 (35:5 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> </annotations> </chapter> <chapter num="54" heading="Home and Community-Based Options Waiver"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Bathing and completing personal hygiene routines;</text> </paragraph> <paragraph num="(b)"> <text>Dressing and changing clothes;</text> </paragraph> <paragraph num="(c)"> <text>Eating;</text> </paragraph> <paragraph num="(d)"> <text>Toileting, including:</text> <paragraph num="(i)"> <text>Bladder and bowel requirements;</text> </paragraph> <paragraph num="(ii)"> <text>Routines associated with the achievement or maintenance of continence; and</text> </paragraph> <paragraph num="(iii)"> <text>Incontinence care;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Mobility, including:</text> <paragraph num="(i)"> <text>Transferring from a bed, chair, or other structure;</text> </paragraph> <paragraph num="(ii)"> <text>Moving, turning, and positioning the body while in bed or in a wheelchair; and</text> </paragraph> <paragraph num="(iii)"> <text>Moving about indoors or outdoors.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Area agency” has the meaning stated in Human Services Article, §10-101(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14.</text> </paragraph> <paragraph num="(4)"> <text>“Case management” means services which assist an applicant or a participant in gaining access to the waiver services covered under this chapter, as well as to other services under the Medical Assistance Program.</text> </paragraph> <paragraph num="(5)"> <text>“Case manager” means an individual performing case management services under a waiver program.</text> </paragraph> <paragraph num="(6)"> <text>Community Setting.</text> <paragraph num="(a)"> <text>“Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to:</text> <paragraph num="(i)"> <text>Seek employment and work in competitive integrated settings;</text> </paragraph> <paragraph num="(ii)"> <text>Engage in community life;</text> </paragraph> <paragraph num="(iii)"> <text>Control personal resources; and</text> </paragraph> <paragraph num="(iv)"> <text>Receive services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Community setting” does not mean:</text> <paragraph num="(i)"> <text>Hospitals;</text> </paragraph> <paragraph num="(ii)"> <text>Nursing facilities;</text> </paragraph> <paragraph num="(iii)"> <text>Institutions for mental diseases;</text> </paragraph> <paragraph num="(iv)"> <text>Intermediate care facilities for individuals with intellectual disabilities;</text> </paragraph> <paragraph num="(v)"> <text>Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02;</text> </paragraph> <paragraph num="(vi)"> <text>Prisons;</text> </paragraph> <paragraph num="(vii)"> <text>Residential treatment centers; or</text> </paragraph> <paragraph num="(viii)"> <text>Any establishment that furnishes food, shelter, and some treatment or services to four or more persons unrelated to the proprietor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department.</text> </paragraph> <paragraph num="(8)"> <text>“Family member” means an adult who:</text> <paragraph num="(a)"> <text>Lives with or provides care to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Is not paid to provide the care.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Home” means the participant's place of residence in a community setting.</text> </paragraph> <paragraph num="(10)"> <text>“Home and Community-Based Options Waiver” means the program implemented under this chapter in accordance with the document for this waiver and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified statutory requirements limiting coverage for home and community-based services under the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(11)"> <text>“Instrumental activities of daily living” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Preparing meals;</text> </paragraph> <paragraph num="(b)"> <text>Performing light chores that are incidental to the personal assistance services provided to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries;</text> </paragraph> <paragraph num="(d)"> <text>Nutritional planning;</text> </paragraph> <paragraph num="(e)"> <text>Traveling as needed;</text> </paragraph> <paragraph num="(f)"> <text>Managing finances and handling money;</text> </paragraph> <paragraph num="(g)"> <text>Using the telephone or other appropriate means of communication;</text> </paragraph> <paragraph num="(h)"> <text>Reading; and</text> </paragraph> <paragraph num="(i)"> <text>Planning and making decisions.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Maryland Department of Aging” has the meaning stated in Human Services Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Medicaid” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(14)"> <text>“Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients.</text> </paragraph> <paragraph num="(15)"> <text>“Medical day care” means a program of medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07.</text> </paragraph> <paragraph num="(16)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, ameliorative, palliative or rehabilitative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, the participant's family, or the provider.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10.</text> </paragraph> <paragraph num="(18)"> <text>“Participant” means an individual who:</text> <paragraph num="(a)"> <text>Has been determined to meet the qualifications for participation in the waiver as specified in Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled with the Department to receive Medicaid services.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Person-centered” means that the plan reflects what is important to the individual, what is important for his or her health and welfare, and is developed with input from the individual and the individual's representative when applicable.</text> </paragraph> <paragraph num="(20)"> <text>“Plan of service” means the written, person-centered support plan developed by the applicant or participant with support from the case manager and the individual's representative, when applicable.</text> </paragraph> <paragraph num="(21)"> <text>“Principal” means a person who:</text> <paragraph num="(a)"> <text>Has a direct or indirect ownership or control interest of 5 percent or more in the provider;</text> </paragraph> <paragraph num="(b)"> <text>Is an officer, director, agent, or managing employee of the entity; or</text> </paragraph> <paragraph num="(c)"> <text>Was described in §B(20)(a) of this regulation, but is no longer so described because of a transfer of ownership or control interest to an immediate family member or a member of the household of the person who continues to maintain an interest described in §B(20)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Program” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(23)"> <text>“Provider” has the same meaning stated in COMAR 10.09.36.</text> </paragraph> <paragraph num="(24)"> <text>“Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter.</text> </paragraph> <paragraph num="(25)"> <text>“Recipient” means an individual who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(26)"> <text>“Reportable event ” means an allegation of, or an actual occurrence of, an incident that may pose an immediate or serious risk, or has potential to adversely affect the physical or mental health, safety, or well-being of a waiver applicant or participant, or complaints regarding administrative service or quality of care issues.</text> </paragraph> <paragraph num="(27)"> <text>“Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence.</text> </paragraph> <paragraph num="(28)"> <text>“State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements.</text> </paragraph> <paragraph num="(29)"> <text>“Telehealth” has the meaning stated in COMAR 10.09.49.02.</text> </paragraph> <paragraph num="(30)"> <text>“Waiver applicant” means an individual who is applying for participation in the waiver, to receive the services covered under this chapter.</text> </paragraph> <paragraph num="(31)"> <text>“Waiver” means the Home and Community-Based Options Waiver as implemented through this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensing and Certification Requirements."> <paragraph num="A."> <text>Assisted living services providers shall be licensed by the Department in accordance with COMAR 10.07.14.</text> </paragraph> <paragraph num="B."> <text>The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered:</text> <paragraph num="(1)"> <text>Physicians;</text> </paragraph> <paragraph num="(2)"> <text>Registered nurses;</text> </paragraph> <paragraph num="(3)"> <text>Licensed practical nurses;</text> </paragraph> <paragraph num="(4)"> <text>Occupational therapists;</text> </paragraph> <paragraph num="(5)"> <text>Physical therapists;</text> </paragraph> <paragraph num="(6)"> <text>Dietitians;</text> </paragraph> <paragraph num="(7)"> <text>Nutritionists;</text> </paragraph> <paragraph num="(8)"> <text>Social workers; and</text> </paragraph> <paragraph num="(9)"> <text>Psychologists.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The following shall be appropriately licensed, certified, or approved by the Department to provide services under this chapter:</text> <paragraph num="(1)"> <text>Licensed home health agency under COMAR 10.09.04;</text> </paragraph> <paragraph num="(2)"> <text>Certified residential services agency under COMAR 10.07.05;</text> </paragraph> <paragraph num="(3)"> <text>Nursing facility under COMAR 10.07.02; and</text> </paragraph> <paragraph num="(4)"> <text>Medical day care center under COMAR 10.09.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>To be eligible for participation, an individual shall be determined by the Department to meet the conditions of §§B—E of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Eligibility for waiver services shall be reevaluated every 12 months or more frequently if needed due to a significant change in the participant’s condition, needs, or financial status.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technical Eligibility. To be eligible for services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria if the individual:</text> <paragraph num="(1)"> <text>Has been determined by the Department to need a nursing facility level of care;</text> </paragraph> <paragraph num="(2)"> <text>Is at least 18 years old;</text> </paragraph> <paragraph num="(3)"> <text>Is not simultaneously enrolled for services covered under:</text> <paragraph num="(a)"> <text>Another Medicaid waiver program under the authority of §1915(c) of the Social Security Act; or</text> </paragraph> <paragraph num="(b)"> <text>The Program of All-Inclusive Care for the Elderly (PACE);</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has an active plan of service that:</text> <paragraph num="(a)"> <text>Is based on:</text> <paragraph num="(i)"> <text>The assessment and recommended plan of care; and</text> </paragraph> <paragraph num="(ii)"> <text>Consultation with the applicant or participant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Addresses the applicant’s or participant’s needs;</text> </paragraph> <paragraph num="(c)"> <text>Specifies the names of service providers;</text> </paragraph> <paragraph num="(d)"> <text>Is cost neutral, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than 125 percent of the Program's average per capita-annualized-net payments for nursing facility services. Any assessed participant contributions will not be considered in determining cost neutrality; and</text> </paragraph> <paragraph num="(e)"> <text>Includes the signature of the participant, the individual’s representative if applicable, and the case manager listed within the plan of service;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Is offered the choice between waiver services and nursing facility services;</text> </paragraph> <paragraph num="(6)"> <text>Chooses to receive waiver services;</text> </paragraph> <paragraph num="(7)"> <text>Resides in a home, as defined under Regulation .02B of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Uses at least one waiver service within a 12-month period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medical Assistance Eligibility.</text> <paragraph num="(1)"> <text>An individual is not eligible to receive waiver services during a penalty period imposed under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets.</text> </paragraph> <paragraph num="(2)"> <text>All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to waiver applicants and participants, with the following exceptions:</text> <paragraph num="(a)"> <text>COMAR 10.09.24.04J(1)—(3);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.24.08G;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24.10C;</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.09.24.10D(4)—(6);</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.09.24.10-1C(3)(a); and</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.09.24.15A-2(2).</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Cost of Care.</text> <paragraph num="(1)"> <text>For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order:</text> <paragraph num="(a)"> <text>A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's charge, not exceeding $420 per month, for room and board;</text> </paragraph> <paragraph num="(b)"> <text>A spousal or family maintenance allowance, or both, if applicable, in accordance with COMAR 10.09.24.10-1C(3)(b) and (c); and</text> </paragraph> <paragraph num="(c)"> <text>Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f)—(h).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services.</text> </paragraph> <paragraph num="(3)"> <text>The participant shall pay the amount of available income for the participant’s cost of care, and the assisted living provider’s monthly charge for room and board, directly to the assisted living services provider.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Waiver Eligibility. Based on the criteria established in §§A—C of this regulation an applicant's eligibility for services under this chapter shall be established by the Department based on the following policies for the effective date of waiver eligibility:</text> <paragraph num="(1)"> <text>No retroactive eligibility; and</text> </paragraph> <paragraph num="(2)"> <text>Waiver eligibility may not begin before the latest of the following five dates:</text> <paragraph num="(a)"> <text>Waiver application date;</text> </paragraph> <paragraph num="(b)"> <text>Effective date of medical certification for the waiver's institutional level of care;</text> </paragraph> <paragraph num="(c)"> <text>Date that the applicant's written waiver plan of service is established, which shall include at least one waiver service and may be a provisional plan for not more than the first 60 days of waiver enrollment;</text> </paragraph> <paragraph num="(d)"> <text>Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; and</text> </paragraph> <paragraph num="(e)"> <text>Date of the applicant's discharge from institutionalization in a long term care facility, if applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Annual Cap and Registry for Waiver Participation.</text> <paragraph num="(1)"> <text>The Department shall establish an annual cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding.</text> </paragraph> <paragraph num="(2)"> <text>Eligible individuals shall be enrolled in the waiver on a first-come, first-served basis until the annual cap on waiver participation is reached.</text> </paragraph> <paragraph num="(3)"> <text>Once the annual cap on waiver participation is reached:</text> <paragraph num="(a)"> <text>A registry list shall be established for individuals interested in applying for waiver services;</text> </paragraph> <paragraph num="(b)"> <text>Individuals on the registry shall have an opportunity to apply for the waiver in accordance with procedures established by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>The Department and CMS may authorize increasing the waiver cap if the Department determines that sufficient Program funds are available to reimburse the services recommended in the individual's plan of service and the participant's other Program services for the remainder of the State fiscal year.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Individuals in nursing facilities who are receiving Medicaid services for at least 30 days may apply directly for the waiver without being put on the registry list.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Termination of Participation.</text> <paragraph num="(1)"> <text>A participant shall be terminated from participation in the waiver if the participant:</text> <paragraph num="(a)"> <text>No longer meets the eligibility requirements specified in §§B—E of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Voluntarily chooses, or the participant’s authorized representative chooses on the participant’s behalf, to disenroll from the waiver program;</text> </paragraph> <paragraph num="(c)"> <text>Moves to another state;</text> </paragraph> <paragraph num="(d)"> <text>Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or</text> </paragraph> <paragraph num="(e)"> <text>Dies.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual is terminated from the waiver, the same individual may re-enter the waiver during the same waiver year, or within 90 days of termination contingent on waiver capacity, provided that the individual meets all of the eligibility requirements of the waiver.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Provider Participation — General Requirements."> <paragraph num="A."> <text>To participate as a provider of a service covered under this chapter a provider shall:</text> <paragraph num="(1)"> <text>Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Verify the qualifications of all individuals who render services on the provider's behalf, and provide a copy of the current license or credentials upon request;</text> </paragraph> <paragraph num="(3)"> <text>Implement the reporting and follow-up of incidents and complaints in accordance with the Department's established reportable events policy;</text> </paragraph> <paragraph num="(4)"> <text>Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives;</text> </paragraph> <paragraph num="(5)"> <text>Agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter for only those services covered under this chapter which have been:</text> <paragraph num="(a)"> <text>Pre-approved in the participant's plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Provided in a manner consistent with the participant's plan of service; and</text> </paragraph> <paragraph num="(c)"> <text>Identified in the provider agreement as within the scope of the provider's Medicaid participation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and with consultation and agreement by the participant or a participant's representative when applicable;</text> </paragraph> <paragraph num="(8)"> <text>Submit a transition plan to the case manager and participant or participant's representative when applicable when suspending or terminating services;</text> </paragraph> <paragraph num="(9)"> <text>Verify Medicaid eligibility at the beginning of each month that services will be rendered;</text> </paragraph> <paragraph num="(10)"> <text>Not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department;</text> </paragraph> <paragraph num="(11)"> <text>Notify the Department in writing at least 45 days in advance of any:</text> <paragraph num="(a)"> <text>Voluntary closure;</text> </paragraph> <paragraph num="(b)"> <text>Change of ownership;</text> </paragraph> <paragraph num="(c)"> <text>Change of location;</text> </paragraph> <paragraph num="(d)"> <text>Sale of the business;</text> </paragraph> <paragraph num="(e)"> <text>Change in the name under which the provider is doing business; or</text> </paragraph> <paragraph num="(f)"> <text>Change in provider tax identification number;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Include in the notice to the Department regarding any change of status under §A(11) of this regulation, the method for informing waiver participants and representatives of its intent to close, change ownership, change location, or sell its business;</text> </paragraph> <paragraph num="(13)"> <text>Apply for a new license if applicable, whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of waiver services;</text> </paragraph> <paragraph num="(14)"> <text>Submit a Medicaid provider application to the Department if the new owner chooses to participate in the waiver program;</text> </paragraph> <paragraph num="(15)"> <text>Obtain a state and federal background check through the Criminal Justice Information System on all staff in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(16)"> <text>Render services in person, except as expressly authorized by the Department in the regulation governing that service type; and</text> </paragraph> <paragraph num="(17)"> <text>If rendering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have:</text> <paragraph num="(1)"> <text>Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services;</text> </paragraph> <paragraph num="(2)"> <text>Undergone the imposition of sanctions under COMAR 10.09.36.08;</text> </paragraph> <paragraph num="(3)"> <text>Been subject to disciplinary action, including actions by the licensing board, that indicate behavior which is potentially harmful to participants;</text> </paragraph> <paragraph num="(4)"> <text>Been cited by a State agency for deficiencies which affect participants health and safety; or</text> </paragraph> <paragraph num="(5)"> <text>Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to:</text> <paragraph num="(a)"> <text>Failure to meet contractual obligations; or</text> </paragraph> <paragraph num="(b)"> <text>Fraudulent billing practices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider who renders health-related services to participants shall agree to:</text> <paragraph num="(1)"> <text>Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Share and discuss the documented information at the request of the participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A provider, its principals, or its staff may not have a history of behavior or convictions that could be harmful to participants, as evidenced through a State and federal background check conducted in accordance with §A(15) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Specific Conditions for Provider Participation — Assisted Living."> <paragraph num="A."> <text>To participate in the program as a provider of assisted living services under this chapter a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services;</text> </paragraph> <paragraph num="(2)"> <text>Be or employ a manager who is qualified as:</text> <paragraph num="(a)"> <text>A licensed physician;</text> </paragraph> <paragraph num="(b)"> <text>A licensed registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>A licensed practical nurse; or</text> </paragraph> <paragraph num="(d)"> <text>An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Employ an alternate assisted living manager who meets the requirements as specified in §A(2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Have at least one staff person per eight residents on duty at all times during daytime hours, and have a staff-to-resident ratio at night which is adequate to provide the required services and maintain the facility in a safe and orderly condition, with additional staffing if required by the Department depending on residents' functional levels;</text> </paragraph> <paragraph num="(5)"> <text>Participate in training on the waiver billing process and other waiver requirements, as specified by the Department;</text> </paragraph> <paragraph num="(6)"> <text>Have the appropriate insurance coverage to cover the provider and its employees and vehicles if the provider chooses to transport participants to medical, social, recreational, and other services;</text> </paragraph> <paragraph num="(7)"> <text>Cooperate with other service providers and quality assurance monitors by:</text> <paragraph num="(a)"> <text>Facilitating on-site visits of authorized quality assurance monitors to review compliance with waiver and regulatory requirements;</text> </paragraph> <paragraph num="(b)"> <text>Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs;</text> </paragraph> <paragraph num="(c)"> <text>Communicating with a participant's case manager concerning the participant's status, needs, and service provision;</text> </paragraph> <paragraph num="(d)"> <text>Informing the case manager within 1 working day of any significant change in the participant's status and service needs;</text> </paragraph> <paragraph num="(e)"> <text>Facilitating, as necessary and appropriate, the delivery of authorized waiver and State Plan services in the plan of service; and</text> </paragraph> <paragraph num="(f)"> <text>Facilitating waiver participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Submit claims consistent with the provisions of Regulation .22 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall:</text> <paragraph num="(1)"> <text>Be provided to all residents and, where appropriate, the resident's representative, at admission;</text> </paragraph> <paragraph num="(2)"> <text>Be fairly and consistently applied to all residents;</text> </paragraph> <paragraph num="(3)"> <text>Specify that the bed reservation service is not a Medicaid covered service;</text> </paragraph> <paragraph num="(4)"> <text>Clearly state that it is the resident's decision whether to reserve the bed; and</text> </paragraph> <paragraph num="(5)"> <text>Specify that the charges to participants for bed reservation days may not exceed the full Medicaid waiver per diem rate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An assisted living provider may limit waiver participation to a designated unit or units only if approved by Department and the facility resident agreement contains the following provisions:</text> <paragraph num="(1)"> <text>The facility's participation in the Program is limited to one or more designated units and, in order to access Medicaid waiver benefits, the resident shall reside in a designated unit;</text> </paragraph> <paragraph num="(2)"> <text>A resident of a designated unit has a right to apply for the waiver at any time and access waiver benefits without restrictions by the provider when the resident is found eligible by the Program; and</text> </paragraph> <paragraph num="(3)"> <text>A resident not in a designated unit who is otherwise eligible or seeking eligibility for the waiver shall be given first consideration and, with all other factors equal, first priority in admission to a vacant bed in a designated unit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for Provider Participation — Behavior Consultation."> <text>To participate in the program as a provider of behavior consultation services under this chapter a provider shall:</text> <paragraph num="A."> <text>Be:</text> <paragraph num="(1)"> <text>A health services agency that:</text> <paragraph num="(a)"> <text>Employs a qualified individual or individuals to render behavior consultation services; and</text> </paragraph> <paragraph num="(b)"> <text>Assures supervision of the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience or with an appropriate graduate degree; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual who is:</text> <paragraph num="(a)"> <text>Qualified to render behavior consultation services; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed to practice independently;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Assure that the individual who renders behavior consultation services:</text> <paragraph num="(1)"> <text>Is a licensed:</text> <paragraph num="(a)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Psychologist; or</text> </paragraph> <paragraph num="(c)"> <text>Clinical social worker; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has:</text> <paragraph num="(a)"> <text>Direct experience working with adults with behavioral problems; and</text> </paragraph> <paragraph num="(b)"> <text>Demonstrated ability to perform assessments; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for Provider Participation — Senior Center Plus."> <text>To participate in the program as a provider of Senior Center Plus services under this chapter a provider shall:</text> <paragraph num="A."> <text>Be approved and monitored by the Maryland Department of Aging as a nutrition service provider;</text> </paragraph> <paragraph num="B."> <text>Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities;</text> </paragraph> <paragraph num="C."> <text>Assure that the facility provides an accessible environment, in compliance with the Americans with Disabilities Act (ADA), 28 CFR Part 36;</text> </paragraph> <paragraph num="D."> <text>Maintain adequate records on participants, including progress notes and outcomes;</text> </paragraph> <paragraph num="E."> <text>Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels;</text> </paragraph> <paragraph num="F."> <text>Employ as the center's manager or in another staff position an individual who:</text> <paragraph num="(1)"> <text>Is a licensed health professional or a licensed social worker;</text> </paragraph> <paragraph num="(2)"> <text>Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility; and</text> </paragraph> <paragraph num="(3)"> <text>Participates in training specified and approved by the Maryland Department of Aging;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provide Senior Center Plus services to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting;</text> </paragraph> <paragraph num="H."> <text>Serve at least one nutritional meal per day that:</text> <paragraph num="(1)"> <text>Is prepared in a licensed food service establishment;</text> </paragraph> <paragraph num="(2)"> <text>Meets at least 1/3 of the daily recommended dietary allowance; and</text> </paragraph> <paragraph num="(3)"> <text>Does not constitute a full nutritional regimen of three meals per day;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and</text> </paragraph> <paragraph num="J."> <text>Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for Provider Participation — Family Training."> <text>To participate in the Program as a provider of family training under this chapter a provider shall:</text> <paragraph num="A."> <text>Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B—D of this regulation;</text> </paragraph> <paragraph num="B."> <text>Have demonstrated experience with the skill being taught;</text> </paragraph> <paragraph num="C."> <text>Be willing to meet at the participant's home to provide services; and</text> </paragraph> <paragraph num="D."> <text>Employ licensed registered nurses, occupational therapists, physical therapists, or social workers who are appropriately experienced and licensed to provide the needed training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Specific Conditions for Provider Participation — Dietitian and Nutritionist Services."> <text>To participate in the program as a provider of dietitian and nutritionist services under this chapter a provider shall be a:</text> <paragraph num="A."> <text>Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Specific Conditions for Provider Participation — Medical Day Care Services."> <text>To participate in the program as a provider of medical day care services under this chapter a provider shall:</text> <paragraph num="A."> <text>Meet the licensure requirements as provided in COMAR 10.12.04; and</text> </paragraph> <paragraph num="B."> <text>Meet the requirements of COMAR 10.09.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10-1" heading="Specific Conditions for Participation — Respite Care."> <text>To participate in the Program as a provider of respite care services under Regulation .18-1 of this chapter a provider shall be enrolled as a provider of:</text> <paragraph num="A."> <text>Assisted living services under this chapter; or</text> </paragraph> <paragraph num="B."> <text>Nursing facility services under COMAR 10.09.10.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Specific Conditions for Provider Participation — Case Management Services."> <text>To participate in the program as a provider of case management services under this chapter a provider shall:</text> <paragraph num="A."> <text>Be an area agency or other entity designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; and</text> </paragraph> <paragraph num="B."> <text>Agree to be monitored by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Covered Services — General."> <text>The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter when, pursuant to the requirements of this chapter, these services have been pre-approved by the Department in the participant’s plan of service, and billed in accordance with the payment procedures in Regulation .22 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Covered Services — Assisted Living Services."> <paragraph num="A."> <text>Assisted living services shall include the provision of:</text> <paragraph num="(1)"> <text>A structured, supportive environment in a home-like setting;</text> </paragraph> <paragraph num="(2)"> <text>Personal assistance and chore services including:</text> <paragraph num="(a)"> <text>Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities;</text> </paragraph> <paragraph num="(b)"> <text>Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and</text> </paragraph> <paragraph num="(c)"> <text>Menu planning, food shopping, and meal preparation and serving;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Basic personal hygiene supplies, including but not limited to:</text> <paragraph num="(a)"> <text>Soap;</text> </paragraph> <paragraph num="(b)"> <text>Bathroom tissue;</text> </paragraph> <paragraph num="(c)"> <text>Paper towels;</text> </paragraph> <paragraph num="(d)"> <text>Toothpaste;</text> </paragraph> <paragraph num="(e)"> <text>Toothbrush; and</text> </paragraph> <paragraph num="(f)"> <text>Shampoo;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>24-hour supervision of participants to assure health and safety;</text> </paragraph> <paragraph num="(5)"> <text>Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14;</text> </paragraph> <paragraph num="(6)"> <text>Recreational and social activities of a nontherapeutic and nonhabilitative nature which are confined to the assisted living facility and are for the purpose of socialization;</text> </paragraph> <paragraph num="(7)"> <text>Reminding the participant of medical appointments;</text> </paragraph> <paragraph num="(8)"> <text>Assistance with transportation arrangements to needed services;</text> </paragraph> <paragraph num="(9)"> <text>Conferring with the participant's case manager about the participant's status and service needs, as necessary;</text> </paragraph> <paragraph num="(10)"> <text>Assisting the participant in accessing needed medical or mental health services in emergency situations; and</text> </paragraph> <paragraph num="(11)"> <text>Other services specified for assisted living programs in COMAR 10.07.14.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The living environment and service provision shall reflect participants' individualized needs and preferences.</text> </paragraph> <paragraph num="C."> <text>Assisted living services reimbursed under this chapter may not include room and board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Covered Services — Behavior Consultation Services."> <paragraph num="A."> <text>A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §C of this regulation.</text> </paragraph> <paragraph num="B."> <text>Behavior consultation services may be preauthorized by a participant's plan of service when:</text> <paragraph num="(1)"> <text>A participant or the participant's representative request the service due to an identified behavioral issue; or</text> </paragraph> <paragraph num="(2)"> <text>The participant's behavior is:</text> <paragraph num="(a)"> <text>Potentially dangerous to the participant's or another person's health and functioning; or</text> </paragraph> <paragraph num="(b)"> <text>Placing the participant at risk of institutionalization due to health and safety concerns.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Behavior consultation services include a:</text> <paragraph num="(1)"> <text>Home visit by an individual qualified to render services to:</text> <paragraph num="(a)"> <text>Evaluate a participant's behavior;</text> </paragraph> <paragraph num="(b)"> <text>Assess the situation;</text> </paragraph> <paragraph num="(c)"> <text>Determine the contributing factors; and</text> </paragraph> <paragraph num="(d)"> <text>Recommend interventions and treatments; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Written report with the results of the provider’s assessment and recommendations, which shall be reviewed verbally by the participant, the participant’s representative and family when applicable, and the participant’s case manager and caregivers, which may include an assisted living provider, to discuss:</text> <paragraph num="(a)"> <text>The report's findings and recommendations; and</text> </paragraph> <paragraph num="(b)"> <text>A course of action, including any related needed medical interventions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Behavior consultation services do not include:</text> <paragraph num="(1)"> <text>The time spent on related activities before or after the home visit; or</text> </paragraph> <paragraph num="(2)"> <text>The provider's time spent on any supervisory or consultative services provided to the renderer of services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The initial assessment provided in §C of this regulation to evaluate a participant's behavior, assess the situation, and determine the contributing factors shall be performed in person.</text> </paragraph> <paragraph num="F."> <text>The verbal review described in §C(2) of this regulation may be delivered via telehealth if recommendations do not require hands-on training or intervention.</text> </paragraph> <paragraph num="G."> <text>Except as provided in §§E and F of this regulation, behavior consultation services may be rendered via telehealth.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Covered Services — Senior Center Plus."> <paragraph num="A."> <text>A day of service is covered by the Program when the participant attends for at least 4 hours, not including transportation to and from the center.</text> </paragraph> <paragraph num="B."> <text>Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and enhanced socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly, disabled individuals, as well as one nutritious meal shall be available at the center.</text> </paragraph> <paragraph num="C."> <text>This program is designed to promote the participants' optimal functioning and to have a positive impact on the participants' orientation and cognitive ability.</text> </paragraph> <paragraph num="D."> <text>A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services may:</text> <paragraph num="(1)"> <text>Not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and</text> </paragraph> <paragraph num="(2)"> <text>Be reimbursed through some other funding source for transportation services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>This service does not cover:</text> <paragraph num="(1)"> <text>Transportation;</text> </paragraph> <paragraph num="(2)"> <text>Direct health care; or</text> </paragraph> <paragraph num="(3)"> <text>A full regimen of three meals per day.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Covered Services — Family Training."> <paragraph num="A."> <text>The Program covers family training when the service is approved in the plan of service and rendered to a family member by a qualified provider, not including the time spent planning, preparing, setting up or following up after the training.</text> </paragraph> <paragraph num="B."> <text>The training and counseling services may not include services rendered:</text> <paragraph num="(1)"> <text>On a group basis or in a classroom setting; or</text> </paragraph> <paragraph num="(2)"> <text>To a family member of a participant residing in a licensed assisted living facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The topics covered by the training and counseling services shall be:</text> <paragraph num="(1)"> <text>Targeted to the individualized needs of the family member receiving the training, as related to the participant's needs;</text> </paragraph> <paragraph num="(2)"> <text>Sensitive to the educational background, culture, and general environment of the participant or family member receiving the training; and</text> </paragraph> <paragraph num="(3)"> <text>Specified in the plan of service as necessary to:</text> <paragraph num="(a)"> <text>Ensure the participant's health and safety; and</text> </paragraph> <paragraph num="(b)"> <text>Prevent the participant's institutionalization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The training and counseling services may include:</text> <paragraph num="(1)"> <text>Instruction on treatment regimens and dementia;</text> </paragraph> <paragraph num="(2)"> <text>Use of equipment specified in the plan of service;</text> </paragraph> <paragraph num="(3)"> <text>Other issues; or</text> </paragraph> <paragraph num="(4)"> <text>Follow-up training as authorized.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The initial assessment for training and counseling following a rehabilitative or hospital stay shall be performed in person.</text> </paragraph> <paragraph num="F."> <text>If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person.</text> </paragraph> <paragraph num="G."> <text>Except as provided in §§E and F of this regulation, family training services may be rendered via telehealth.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Covered Services — Dietitian and Nutritionist Services."> <paragraph num="A."> <text>Dietitian and nutritionist services shall include:</text> <paragraph num="(1)"> <text>The provision of nutrition care plan outcomes and approaches;</text> </paragraph> <paragraph num="(2)"> <text>Nutrition care planning, nutrition assessment, and dietetic instruction; and</text> </paragraph> <paragraph num="(3)"> <text>Services within the scope of practice of the nutritionist's or dietitian's license, as defined by:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title V, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations under COMAR 10.56 for the Board of Dietetic Practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dietitian and nutritionist services may not include services rendered:</text> <paragraph num="(1)"> <text>On a group basis or in a classroom setting; or</text> </paragraph> <paragraph num="(2)"> <text>To participants residing in a licensed assisted living facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The services shall be:</text> <paragraph num="(1)"> <text>Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian;</text> </paragraph> <paragraph num="(2)"> <text>Targeted to the individualized needs of the participant, rather than being of general interest;</text> </paragraph> <paragraph num="(3)"> <text>Sensitive to the educational background, culture, religion, eating habits and preferences, and general environment of the participant; and</text> </paragraph> <paragraph num="(4)"> <text>Specified in the participant's plan of service as necessary to:</text> <paragraph num="(a)"> <text>Ensure the participant's health and safety; and</text> </paragraph> <paragraph num="(b)"> <text>Prevent the participant's institutionalization or hospitalization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The initial assessment and counseling following a rehabilitative or hospital stay shall be performed in person.</text> </paragraph> <paragraph num="E."> <text>If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person.</text> </paragraph> <paragraph num="F."> <text>Except as provided in §§D and E of this regulation, dietitian and nutrition services may be rendered via telehealth.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Covered Services — Medical Day Care Services."> <text>A provider shall render medical day care services in accordance with COMAR 10.09.07.</text> </regulation> <regulation prefix="Regulation" num=".18-1" heading="Covered Services — Respite Care."> <text>Respite care services shall:</text> <paragraph num="A."> <text>Be provided to participants who, due to physical or cognitive impairments, are unable to care for themselves;</text> </paragraph> <paragraph num="B."> <text>Be furnished on a short-term basis because of the absence or need for relief of an individual normally providing the care;</text> </paragraph> <paragraph num="C."> <text>Provide a period of rest and renewal, which contributes to maintaining the participant at home in the community;</text> </paragraph> <paragraph num="D."> <text>Be provided at planned intervals, in a time of crisis, or as needed;</text> </paragraph> <paragraph num="E."> <text>Include the participant's room and board;</text> </paragraph> <paragraph num="F."> <text>Include overnight care; and</text> </paragraph> <paragraph num="G."> <text>Including the following services:</text> <paragraph num="(1)"> <text>Supervising participants with cognitive impairments to ensure the individual’s health and safety;</text> </paragraph> <paragraph num="(2)"> <text>Assisting participants with functional impairments to perform activities of daily living or instrumental activities of daily living; and</text> </paragraph> <paragraph num="(3)"> <text>Delegated nursing functions, such as medication assistance or administration by appropriately trained, certified, and supervised staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Covered Services — Case Management Services."> <paragraph num="A."> <text>Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant.</text> </paragraph> <paragraph num="B."> <text>Case management services include time spent by a qualified provider conducting any of the following activities:</text> <paragraph num="(1)"> <text>Assisting with the initial or annual waiver eligibility process;</text> </paragraph> <paragraph num="(2)"> <text>Assisting with the application and supporting the individual in maintaining all public and private benefits, resources, and entitlements;</text> </paragraph> <paragraph num="(3)"> <text>Conducting an assessment of needs, and developing a person-centered plan of service, to include all services needed to live safely in the community;</text> </paragraph> <paragraph num="(4)"> <text>Assisting the participant with referrals, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to:</text> <paragraph num="(a)"> <text>Behavioral health;</text> </paragraph> <paragraph num="(b)"> <text>Educational services;</text> </paragraph> <paragraph num="(c)"> <text>Disposable medical supplies and durable medical equipment;</text> </paragraph> <paragraph num="(d)"> <text>Housing;</text> </paragraph> <paragraph num="(e)"> <text>Medical services; and</text> </paragraph> <paragraph num="(f)"> <text>Social services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Monitoring the provision of services to determine if services are received in accordance with the plan of services;</text> </paragraph> <paragraph num="(6)"> <text>Facilitating referrals to other programs if the individual is denied waiver services; and</text> </paragraph> <paragraph num="(7)"> <text>Using information technology systems developed by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Conditions for Reimbursement."> <text>The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter, if provided in accordance with the requirements of this chapter and if the service:</text> <paragraph num="A."> <text>Is recommended on the participant’s plan of service as necessary in order to:</text> <paragraph num="(1)"> <text>Prevent the applicant’s or participant’s admission to an institution; or</text> </paragraph> <paragraph num="(2)"> <text>Assure the health and safety of an applicant or participant in the community;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Has been pre-approved by the Department in the participant’s plan of service;</text> </paragraph> <paragraph num="C."> <text>Is provided to an enrolled participant;</text> </paragraph> <paragraph num="D."> <text>Is medically necessary;</text> </paragraph> <paragraph num="E."> <text>Is provided by a Medicaid provider who meets the conditions for participation under this chapter; and</text> </paragraph> <paragraph num="F."> <text>Is cost-neutral for the Program, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than:</text> <paragraph num="(1)"> <text>125 percent of the Program's average per capita-annualized-net payments for nursing facility services for a waiver participant in accordance with the provisions of Regulation .03B(4)(d) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>In the aggregate for all waiver participants, 100 percent of the Program’s average per capita-annualized-net payments for nursing facility services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Limitations."> <paragraph num="A."> <text>Reimbursement may be made by the Program only when the requirements of this chapter are met.</text> </paragraph> <paragraph num="B."> <text>The Program may not reimburse the following combinations of services for a participant for the same date of service:</text> <paragraph num="(1)"> <text>Senior Center Plus and Medical Day Care under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Assisted living services under this chapter and personal assistance services under COMAR 10.09.20 or COMAR 10.09.84;</text> </paragraph> <paragraph num="(3)"> <text>Assisted living services and respite care under this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>Respite care under this chapter and personal assistance services covered under COMAR 10.09.20 or COMAR 10.09.84.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursement by the Program for respite care shall be limited to 14 days per occurrence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Payment Procedures."> <paragraph num="A."> <text>To receive payment as a provider of services covered under Regulations .13—.19 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rates established in §D of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Rates.</text> <paragraph num="(1)"> <text>For dates of service beginning July 1, 2022, through June 30, 2024, fees per unit of service shall be as follows:</text> <paragraph num="(a)"> <text>Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $81.57 per day;</text> </paragraph> <paragraph num="(b)"> <text>Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $102.94 per day;</text> </paragraph> <paragraph num="(c)"> <text>Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $61.21 per day;</text> </paragraph> <paragraph num="(d)"> <text>Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $77.18 per day;</text> </paragraph> <paragraph num="(e)"> <text>Behavioral Consultation: reimbursed at the maximum rate of $89.22 per hour;</text> </paragraph> <paragraph num="(f)"> <text>Case Management — Administrative: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit;</text> </paragraph> <paragraph num="(g)"> <text>Case Management — Comprehensive: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit;</text> </paragraph> <paragraph num="(h)"> <text>Case Management — Ongoing: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit;</text> </paragraph> <paragraph num="(i)"> <text>Dietitian and Nutritionist Services: reimbursed at the maximum rate of $89.22 per hour;</text> </paragraph> <paragraph num="(j)"> <text>Family 1/1 Training: reimbursed at the maximum rate of $89.22 per hour;</text> </paragraph> <paragraph num="(k)"> <text>Medical Day Care Services: reimbursed at the maximum rate of $104.81 per day; and</text> </paragraph> <paragraph num="(l)"> <text>Senior Center Plus: reimbursed at the maximum rate of $64.90 per day.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For dates of service beginning July 1, 2024, fees per unit of service shall be as follows:</text> <paragraph num="(a)"> <text>Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $90.74 per day;</text> </paragraph> <paragraph num="(b)"> <text>Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $114.51 per day;</text> </paragraph> <paragraph num="(c)"> <text>Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $68.09 per day;</text> </paragraph> <paragraph num="(d)"> <text>Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $85.86 per day;</text> </paragraph> <paragraph num="(e)"> <text>Behavioral Consultation: reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(f)"> <text>Case Management — Administrative: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(g)"> <text>Case Management — Comprehensive: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(h)"> <text>Case Management — Ongoing: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(i)"> <text>Dietitian and Nutritionist Services: reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(j)"> <text>Family 1/1 Training: reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(k)"> <text>Medical Day Care Services: reimbursed at the maximum rate of $116.59 per day; and</text> </paragraph> <paragraph num="(l)"> <text>Senior Center Plus: reimbursed at the maximum rate of $72.19 per day.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Program’s rates for covered services under Regulations .13—.19 of this chapter shall be adjusted subject to the limitations of the State budget.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".24" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".25" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <regulation prefix="Regulation" num=".27" heading="Implementation Date."> <text>This chapter shall be implemented January 6, 2014.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, 15-132, and 15-141.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—19 adopted as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); adopted permanently effective October 26, 1993 (20:21 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 21, 2004 (31:12 Md. R. 912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 17, 2006 (33:14 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33C amended effective June 20, 2005 (32:12 Md. R. 1046); July 17, 2006 (33:14 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective September 20, 2010 (37:19 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-1 adopted effective April 15, 2013 (40:7 Md. R. 610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30-1 adopted effective April 15, 2013 (40:7 Md. R. 610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32F, G amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32H adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33C amended effective April 6, 2009 (36:7 Md. R. 524); February 8, 2010 (37:3 Md. R. 176); October 31, 2011 (38:22 Md. R. 1346); April 15, 2013 (40:7 Md. R. 610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33D adopted effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.37 repealed and new Regulations .01—.27 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10-1 adopted effective December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E, F, G adopted effective November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17D, E, F adopted effective November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 adopted effective December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective January 30, 2017 (44:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21B amended effective December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21C adopted effective December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C amended effective July 4, 2016 (43:13 Md. R. 712); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22D amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="55" heading="Physician Assistants"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced duties” means medical acts that require training and certification beyond the basic physician assistant education program.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Delegation agreement” means a document that is executed by a licensed physician and a physician assistant containing the requirements of Health Occupation Article, §15-302, Annotated Code of Maryland, and COMAR 10.32.03.05.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Dispense” means to dispense starter dosages or drug samples.</text> </paragraph> <paragraph num="(6)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(7)"> <text>“Modification” means any change to the delegation agreement that governs the physician assistant’s performance of duties, including but not limited to practice location, scope of practice, change of supervising physician (primary or alternate), and prescriptive authority.</text> </paragraph> <paragraph num="(8)"> <text>“Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02.</text> </paragraph> <paragraph num="(9)"> <text>“Physician assistant” means an individual who is licensed to practice medicine with physician supervision.</text> </paragraph> <paragraph num="(10)"> <text>“Practice as a physician assistant” means the performance of medical acts that are:</text> <paragraph num="(a)"> <text>Delegated by a supervising physician to a physician assistant;</text> </paragraph> <paragraph num="(b)"> <text>Within the supervising physician’s scope of practice; and</text> </paragraph> <paragraph num="(c)"> <text>Appropriate to the physician assistant’s education, training, and experience.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(12)"> <text>“Provider” means a licensed physician assistant who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(13)"> <text>“Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(14)"> <text>"Supervision” means the responsibility of the physician to exercise on-site supervision or to be able to provide immediate available direction for the physician assistants performing delegated medical acts, and includes:</text> <paragraph num="(a)"> <text>Oversight of the physician assistant and acceptance of direct responsibility for the patient services and care rendered by the physician assistant;</text> </paragraph> <paragraph num="(b)"> <text>Continuous availability to the physician assistant either in person, by telephone, by electronic means, or by some other form of telecommunication; and</text> </paragraph> <paragraph num="(c)"> <text>Designation of one or more alternate supervising physicians.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License and Certification Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A physician assistant applying for provider status shall:</text> <paragraph num="(1)"> <text>Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Be in compliance with requirements set forth in COMAR 10.32.03;</text> </paragraph> <paragraph num="(3)"> <text>If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and</text> </paragraph> <paragraph num="(4)"> <text>If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A physician having a written agreement to supervise a physician assistant shall:</text> <paragraph num="(1)"> <text>Be licensed to practice medicine in the state in which the physician assistant is providing services;</text> </paragraph> <paragraph num="(2)"> <text>Delegate only medical acts that are within the scope of the practice of the physician and are suitable to be performed by the physician assistant, taking into account the physician assistant’s education, training, and level of competence;</text> </paragraph> <paragraph num="(3)"> <text>Accept Program reimbursement as payment in full for services provided;</text> </paragraph> <paragraph num="(4)"> <text>Establish and review drug and other medical guidelines with the physician assistant;</text> </paragraph> <paragraph num="(5)"> <text>Participate with the physician assistant in reviewing and discussing medical diagnoses and the therapeutic and corrective measures employed in the practice setting;</text> </paragraph> <paragraph num="(6)"> <text>Be available for consultation in person, by telephone, electronic means, or by some other form of telecommunication; and</text> </paragraph> <paragraph num="(7)"> <text>Designate an alternate supervising physician if the physician identified in the delegation agreement temporarily becomes unavailable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For hospitals, correctional facilities, detention centers, or public health facilities, the primary supervising physician shall keep an ongoing list of all approved alternate supervising physicians within the alternate supervising physicians’ scopes of practice, with each alternate supervising physician’s signature and date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A physician assistant shall:</text> <paragraph num="(1)"> <text>Meet all general provider requirements set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician assistant shall:</text> <paragraph num="(1)"> <text>Have a written and executed delegation agreement with a licensed physician approved by the Board, or as required by the state in which services are provided; and</text> </paragraph> <paragraph num="(2)"> <text>If the primary supervising physician delegates the prescribing of controlled dangerous substances to a physician assistant, if required by applicable law, the physician assistant shall:</text> <paragraph num="(a)"> <text>Obtain a Maryland Controlled Dangerous Substance (MCDS) license from the Maryland Division of Drug Control; and</text> </paragraph> <paragraph num="(b)"> <text>After obtaining an MCDS license:</text> <paragraph num="(i)"> <text>Register with the Drug Enforcement Administration (DEA); and</text> </paragraph> <paragraph num="(ii)"> <text>Obtain a license from the DEA.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To participate as a provider, the physician assistant shall submit to the Program a copy of the provider's:</text> <paragraph num="(1)"> <text>Current approved delegation agreement; and</text> </paragraph> <paragraph num="(2)"> <text>Current license to practice in the state in which services are provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Modification of Delegation Agreement.</text> <paragraph num="(1)"> <text>If the provider's approved written delegation agreement with the physician is modified or terminated by either party, the physician assistant and supervising physician shall notify the Program within 5 days in writing.</text> </paragraph> <paragraph num="(2)"> <text>If the delegation agreement is modified, the physician assistant and the supervising physician shall submit to the Program a copy of the modified or new written agreement.</text> </paragraph> <paragraph num="(3)"> <text>If the duties of the physician assistant are limited, reduced, or result in other changes of employment that might be grounds for disciplinary actions under Health Occupations Article, §15-314, Annotated Code of Maryland, the supervising physician, hospital, alternative health care system, or employer shall notify the Program immediately or within 5 days in writing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A physician assistant may practice in Maryland:</text> <paragraph num="(1)"> <text>Only in accordance with the delegation agreement approved by the Board; or</text> </paragraph> <paragraph num="(2)"> <text>If out-of-State, only in accordance with the scope of practice allowed by the licensing authority in the state in which services are provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers medically necessary services rendered to participants in accordance with:</text> <paragraph num="(1)"> <text>The functions allowed under:</text> <paragraph num="(a)"> <text>The Physician Assistant’s Practice Act;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.32.03; and</text> </paragraph> <paragraph num="(c)"> <text>The physician assistant’s written delegation agreement with a physician; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If out-of-State, those functions authorized in the state in which the services are provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The services in §A of this regulation shall be described in the participant's medical record in sufficient detail to support the invoice submitted for those services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following under these regulations:</text> <paragraph num="A."> <text>Services not encompassed by the physician assistant’s written delegation agreement with the physician, if required by the state in which services are provided;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Services prohibited by the Board;</text> </paragraph> <paragraph num="D."> <text>Services prohibited in the state in which services are provided;</text> </paragraph> <paragraph num="E."> <text>Physician assistant services included as part of the cost of an inpatient facility, hospital outpatient department, or freestanding clinic;</text> </paragraph> <paragraph num="F."> <text>Visits by or to the physician assistant solely for the purpose of the following:</text> <paragraph num="(1)"> <text>Prescription, drug, or food supplement pickup;</text> </paragraph> <paragraph num="(2)"> <text>Recording of an electrocardiogram;</text> </paragraph> <paragraph num="(3)"> <text>Ascertaining the patient's weight;</text> </paragraph> <paragraph num="(4)"> <text>Interpretation of laboratory tests or panels; or</text> </paragraph> <paragraph num="(5)"> <text>Prescribing or administering oral medications;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Drugs and supplies which are acquired by the licensed and certified physician assistant at no cost;</text> </paragraph> <paragraph num="H."> <text>Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take appropriate oral medications are documented in the patient's medical record;</text> </paragraph> <paragraph num="I."> <text>More than one visit per day per participant unless adequately documented as an emergency situation;</text> </paragraph> <paragraph num="J."> <text>Services paid under the free-standing dialysis program described in COMAR 10.09.22;</text> </paragraph> <paragraph num="K."> <text>Physician assistant billings for those laboratory or X-ray services performed by another facility, which shall bill the Program directly;</text> </paragraph> <paragraph num="L."> <text>Immunizations required for travel outside the continental United States;</text> </paragraph> <paragraph num="M."> <text>Acupuncture;</text> </paragraph> <paragraph num="N."> <text>Hypnosis;</text> </paragraph> <paragraph num="O."> <text>Travel expenses;</text> </paragraph> <paragraph num="P."> <text>Prescriptions and injections for central nervous system stimulants and anoretic agents when used for weight control;</text> </paragraph> <paragraph num="Q."> <text>Investigational or experimental drugs and procedures;</text> </paragraph> <paragraph num="R."> <text>Services denied by Medicare as not medically justified; and</text> </paragraph> <paragraph num="S."> <text>Services for which the patient specifically requests to see a physician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment in the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by any properly completed forms required by the Department.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider's customary charge to the general public for similar services and charge the provider's acquisition cost for injectable drugs or dispensed medical supplies. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §D of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall reimburse the physician assistant for covered services at the lesser of:</text> <paragraph num="(1)"> <text>The provider's customary charge unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The maximum rates according to COMAR 10.09.02.07E.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payments on Medicare claims are authorized, if:</text> <paragraph num="(1)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(2)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(3)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(4)"> <text>Medicare has determined that services were medically justified; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall make supplemental payments on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance shall be paid in full; and</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail; and</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a participant's medical record when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Program may not make direct payment to participants.</text> </paragraph> <paragraph num="I."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="J."> <text>Physician assistants who are employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective September 26, 2016 (43:19 Md. R. 1072)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective July 10, 2023 (50:13 Md. R. 512)</annotation> </annotations> </chapter> <chapter num="56" heading="Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Active Treatment.</text> <paragraph num="(a)"> <text>“Active treatment” means, according to 42 CFR §483.440(a), a continuous active treatment program which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services, and related services that is directed toward the:</text> <paragraph num="(i)"> <text>Acquisition of the behaviors necessary for the individual to function with as much self-determination and independence as possible; or</text> </paragraph> <paragraph num="(ii)"> <text>Prevention or deceleration of regression or loss of current optimal functional status.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Active treatment” does not mean, according to 42 CFR §483.440(a), services to maintain generally independent individuals who are able to function with little supervision or in the absence of a continuous active treatment program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who is applying as a participant in the Autism Waiver.</text> </paragraph> <paragraph num="(3)"> <text>“Autism” has the meaning stated in §C of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>“Autism Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder.</text> </paragraph> <paragraph num="(5)"> <text>“Certified special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(7)"> <text>“Developmentally disabled” means a condition, as specified in 42 CFR §435.1010 for persons with related conditions, resulting in a severe, chronic disability which meets all of the following conditions:</text> <paragraph num="(a)"> <text>Is attributable to:</text> <paragraph num="(i)"> <text>Cerebral palsy or epilepsy; or</text> </paragraph> <paragraph num="(ii)"> <text>A condition such as autism, except for mental illness, which is found to be closely related to intellectual disability because the condition results in impairment of general intellectual functioning or adaptive behavior similar to that of intellectually disabled individuals, and requires treatment or services similar to those required for intellectually disabled individuals;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is manifested before the individual is 22 years old;</text> </paragraph> <paragraph num="(c)"> <text>Is likely to continue indefinitely; and</text> </paragraph> <paragraph num="(d)"> <text>Results in substantial functional limitations in three or more of the following areas of major life activities:</text> <paragraph num="(i)"> <text>Self-care;</text> </paragraph> <paragraph num="(ii)"> <text>Understanding and use of language;</text> </paragraph> <paragraph num="(iii)"> <text>Learning;</text> </paragraph> <paragraph num="(iv)"> <text>Mobility;</text> </paragraph> <paragraph num="(v)"> <text>Self-direction;</text> </paragraph> <paragraph num="(vi)"> <text>Capacity for independent living; or</text> </paragraph> <paragraph num="(vii)"> <text>Other areas of major life activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Early intervention services” means services that:</text> <paragraph num="(a)"> <text>Are designed to meet the developmental needs of infants and toddlers with disabilities;</text> </paragraph> <paragraph num="(b)"> <text>Are provided under public supervision and in conformity with an individualized family service plan; and</text> </paragraph> <paragraph num="(c)"> <text>Meet applicable State and federal standards.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Eligible person” means an individual who meets the qualifications, as specified in Regulation .02 of this chapter, for participation in the Autism Waiver.</text> </paragraph> <paragraph num="(10)"> <text>“Family” means adults who:</text> <paragraph num="(a)"> <text>Live with or provide care to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Are not paid to provide the care.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“HIPAA” means the Health Insurance Portability and Accountability Act of 1996 developed to improve portability of health insurance coverage, reduce healthcare fraud and abuse, and protect individual privacy of personal health records.</text> </paragraph> <paragraph num="(12)"> <text>“Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under this chapter in accordance with the document, and any amendments to it, submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to §1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program.</text> </paragraph> <paragraph num="(13)"> <text>“ICF-ID level of care” means an assessment that an individual needs the level of services provided in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF-ID), including active treatment.</text> </paragraph> <paragraph num="(14)"> <text>“Individualized education program (IEP)” means a written statement for a student with a disability that is developed, reviewed, and revised in accordance with 20 U.S.C. §1414 and COMAR 10.09.52.</text> </paragraph> <paragraph num="(15)"> <text>“Individualized family service plan (IFSP)” means a written, individualized plan for early intervention and other services for an infant or toddler, in accordance with COMAR 10.09.40, 10.09.50, and 13A.13.01.</text> </paragraph> <paragraph num="(16)"> <text>“Intermediate care facility for individuals with intellectual disabilities (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that:</text> <paragraph num="(a)"> <text>Is primarily for the diagnosis, treatment, or rehabilitation of individuals with intellectual disabilities or persons with related conditions; and</text> </paragraph> <paragraph num="(b)"> <text>Provides, in a protected residential setting, ongoing evaluation, planning, 24-hour supervision, coordination, and integration of health or rehabilitative services to help each individual function at the individual's greatest ability.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the State Department of Education.</text> </paragraph> <paragraph num="(18)"> <text>“Local school system” means the public local education agency in each jurisdiction.</text> </paragraph> <paragraph num="(19)"> <text>“Medicaid” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(20)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01B.</text> </paragraph> <paragraph num="(21)"> <text>“Multidisciplinary team” means the IEP team or IFSP participants, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a participant.</text> </paragraph> <paragraph num="(22)"> <text>Parent.</text> <paragraph num="(a)"> <text>“Parent” means the adult representative of a minor applicant or participant.</text> </paragraph> <paragraph num="(b)"> <text>“Parent” includes:</text> <paragraph num="(i)"> <text>A natural or adoptive parent;</text> </paragraph> <paragraph num="(ii)"> <text>A legal guardian;</text> </paragraph> <paragraph num="(iii)"> <text>A person acting in the place of a parent, such as a grandparent or stepparent, with whom the participant lives, including those relatives or stepparents who are foster parents;</text> </paragraph> <paragraph num="(iv)"> <text>An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act (IDEA); and</text> </paragraph> <paragraph num="(v)"> <text>Any other person who is legally responsible for the participant's welfare.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Participant” means an eligible person who is enrolled in the Autism Waiver.</text> </paragraph> <paragraph num="(24)"> <text>“Positive behavior intervention” means a range of intervention strategies that are designed to prevent problem behaviors while teaching socially appropriate alternative behaviors.</text> </paragraph> <paragraph num="(25)"> <text>“Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B.</text> </paragraph> <paragraph num="(26)"> <text>“Provider” means an individual, association, partnership, corporation, or unincorporated group that:</text> <paragraph num="(a)"> <text>Is approved as meeting the conditions for waiver participation specified in this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Has enrolled with the Program to provide one or more of the waiver services covered under this chapter.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Provider agreement” means a contract between the Program and a provider.</text> </paragraph> <paragraph num="(28)"> <text>“Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder.</text> </paragraph> <paragraph num="(29)"> <text>“Recipient” means an individual who is certified by the Department as eligible to receive Program benefits.</text> </paragraph> <paragraph num="(30)"> <text>“Reportable event policy” means a process developed to protect the health and safety of waiver participants in the community by identifying, documenting, and resolving complaints and incidents.</text> </paragraph> <paragraph num="(31)"> <text>“Retainer payment” means payment made to providers of residential habilitation services while the participant is hospitalized or absent from the residential habilitation program.</text> </paragraph> <paragraph num="(32)"> <text>“Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food which are provided in or associated with an individual's place of residence.</text> </paragraph> <paragraph num="(33)"> <text>“Service coordinator” means the individual who provides case management services for Autism Waiver participants in accordance with COMAR 10.09.52.</text> </paragraph> <paragraph num="(34)"> <text>“Special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02.</text> </paragraph> <paragraph num="(35)"> <text>“State Department of Education (MSDE)” means the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws.</text> </paragraph> <paragraph num="(36)"> <text>“State fiscal year” means the 12-month period of July 1 through June 30 over which the State budgets its spending.</text> </paragraph> <paragraph num="(37)"> <text>“State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services according to Title XIX of the Social Security Act, as modified or amended.</text> </paragraph> <paragraph num="(38)"> <text>“Waiver plan of care” means the written, individualized treatment plan developed for a participant, which identifies the waiver services covered under this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Autism.</text> <paragraph num="(1)"> <text>“Autism” means autism spectrum disorder, which is diagnosed when an individual has a total of six or more of the following items under §C(1)(a), (b), and (c) of this regulation, with at least two from §C(1)(a) and one each from §C(1)(b) and (c):</text> <paragraph num="(a)"> <text>Qualitative impairment in social interaction, as manifested by at least two of the following:</text> <paragraph num="(i)"> <text>Marked impairment in the use of multiple nonverbal behaviors such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction;</text> </paragraph> <paragraph num="(ii)"> <text>Failure to develop peer relationships appropriate to developmental level;</text> </paragraph> <paragraph num="(iii)"> <text>A lack of spontaneous seeking to share enjoyment, interests, or achievements with other people (for example, by a lack of showing, bringing, or pointing out objects of interest);</text> </paragraph> <paragraph num="(iv)"> <text>Lack of social or emotional reciprocity;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Qualitative impairments in communication as manifested by at least one of the following:</text> <paragraph num="(i)"> <text>Delay in, or total lack of, the development of spoken language, not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime;</text> </paragraph> <paragraph num="(ii)"> <text>In individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others;</text> </paragraph> <paragraph num="(iii)"> <text>Stereotyped and repetitive use of language or idiosyncratic language;</text> </paragraph> <paragraph num="(iv)"> <text>Lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Restricted repetitive and stereotyped patterns of behavior, interests, and activities, as manifested by at least one of the following:</text> <paragraph num="(i)"> <text>Encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus;</text> </paragraph> <paragraph num="(ii)"> <text>Apparently compulsive adherence to specific, nonfunctional routines or rituals;</text> </paragraph> <paragraph num="(iii)"> <text>Stereotyped and repetitive motor mannerisms (for example, hand or finger flapping or twisting, or complex whole body movements);</text> </paragraph> <paragraph num="(iv)"> <text>Persistent preoccupation with parts or objects.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Autism” includes:</text> <paragraph num="(a)"> <text>Delays or abnormal functioning in at least one of the following areas, with onset before age 3 years:</text> <paragraph num="(i)"> <text>Social interaction;</text> </paragraph> <paragraph num="(ii)"> <text>Language as used in social communication; or</text> </paragraph> <paragraph num="(iii)"> <text>Symbolic or imaginative play;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual's behavior that is not better accounted for by Rett's Disorder or Childhood Disintegrative Disorder;</text> </paragraph> <paragraph num="(c)"> <text>Pervasive Developmental Disorder Not Otherwise Specified (including Atypical Autism, Rett's Disorder, and Asperger's Disorder).</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Participant Eligibility."> <paragraph num="A."> <text>Medical Eligibility for the Autism Waiver.</text> <paragraph num="(1)"> <text>To be medically eligible for the services covered under the chapter, an applicant shall be certified by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee to need ICF-IID level of care using the standardized process for determination of eligibility for level of care in an ICF-IID.</text> </paragraph> <paragraph num="(2)"> <text>Every 12 months, or more frequently if determined necessary by the service coordinator or multidisciplinary team due to a significant change in the participant’s condition or needs, a participant’s medical need for ICF-IID level of care shall be reevaluated by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee, as part of the multidisciplinary team process and using the form for determination of eligibility for level of care in an ICF-IID.</text> </paragraph> <paragraph num="(3)"> <text>The form certifying ICF-IID level of care shall be signed by the:</text> <paragraph num="(a)"> <text>Chairman of the multidisciplinary team, who is the official representative of the local school system or local lead agency; and</text> </paragraph> <paragraph num="(b)"> <text>Team's licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Technical Eligibility for the Autism Waiver. An applicant or participant shall be determined by the multidisciplinary team to meet the waiver’s technical eligibility-criteria if the individual:</text> <paragraph num="(1)"> <text>Is between 1 year old and the end of the school year in which the individual turns 21 years old;</text> </paragraph> <paragraph num="(2)"> <text>Is determined to be developmentally disabled and is diagnosed with autism spectrum disorder, every 3 years or more often as requested by MSDE, by a qualified diagnostician using an evaluation methodology considered sufficient by the multidisciplinary team;</text> </paragraph> <paragraph num="(3)"> <text>Uses at least one waiver service monthly, not including family consultation, unless otherwise authorized by the State Department of Education;</text> </paragraph> <paragraph num="(4)"> <text>Has an IFSP or IEP;</text> </paragraph> <paragraph num="(5)"> <text>If the child has an IEP, receives 15 hours or more per week of special education and related services and requires a more intensive therapeutic program than other students or is currently participating in an approved Home and Hospital Program pursuant to the procedures of COMAR 13A.03.05 and 13A.05.01;</text> </paragraph> <paragraph num="(6)"> <text>Is identified through the public education or early intervention service system as being potentially qualified for and needing Autism Waiver services;</text> </paragraph> <paragraph num="(7)"> <text>Can be safely maintained in the community with the assistance of Autism Waiver services;</text> </paragraph> <paragraph num="(8)"> <text>Chooses, or the parent or parents of a minor child chooses on the child’s behalf, to receive Autism Waiver services as an alternative to services in an (ICF-IID), and documents that choice on the consent form for Autism Waiver services; and</text> </paragraph> <paragraph num="(9)"> <text>Is not enrolled in:</text> <paragraph num="(a)"> <text>Home Care for Disabled Children under a Model Waiver, in accordance with COMAR 10.09.27;</text> </paragraph> <paragraph num="(b)"> <text>Community Based Services for Developmentally Disabled Individuals Pursuant to a 1915(c) Waiver, in accordance with COMAR 10.09.26; or</text> </paragraph> <paragraph num="(c)"> <text>Any other Medicaid waiver program under §1915(c) of Title XIX of the Social Security Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Medical Assistance Eligibility.</text> <paragraph num="(1)"> <text>Categorically Needy. A recipient is eligible for Autism Waiver services if the recipient is eligible for Medicaid in the community according to the categorically needy regulations in COMAR 10.09.24 or 10.09.11.</text> </paragraph> <paragraph num="(2)"> <text>Optionally Categorically Needy.</text> <paragraph num="(a)"> <text>An individual is eligible for Autism Waiver services as optionally categorically needy in accordance with 42 CFR §435.217 if the individual's countable income does not exceed 300 percent of the applicable payment rate for Supplemental Security Income (SSI), and the individual's countable resources do not exceed the SSI resource standard for one.</text> </paragraph> <paragraph num="(b)"> <text>For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one.</text> </paragraph> <paragraph num="(c)"> <text>For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income regulations in COMAR 10.09.24 which are applicable to aged, blind, or disabled individuals who are institutionalized, with the exceptions specified in §C(4) of this regulation.</text> </paragraph> <paragraph num="(d)"> <text>For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource regulations set forth in COMAR 10.09.24.08 and .10 which are applicable to aged, blind, or disabled persons who are institutionalized, with the exceptions specified in §C(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual is not eligible to receive Autism Waiver services if a disposal of assets or establishment of a trust results in a penalty under COMAR 10.09.24.08-1 or .08-2, until the penalty period expires.</text> </paragraph> <paragraph num="(4)"> <text>All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to Autism Waiver applicants and participants, with the following exceptions:</text> <paragraph num="(a)"> <text>COMAR 10.09.24.04J(1), (2), and (3);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.24.04K;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24.08G(1);</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.09.24.08H;</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.09.24.09;</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.09.24.10; and</text> </paragraph> <paragraph num="(h)"> <text>COMAR 10.09.24.10-1.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Post Eligibility Determination of Available Income. The participant's or parents' income may not be applied toward the costs of the participant's:</text> <paragraph num="(a)"> <text>Autism Waiver services; or</text> </paragraph> <paragraph num="(b)"> <text>Room and board in a residential habilitation facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Autism Waiver Eligibility.</text> <paragraph num="(1)"> <text>If an applicant is verified by the multidisciplinary team and the State Department of Education:</text> <paragraph num="(a)"> <text>To meet all of the criteria specified in §§A—C of this regulation, the participant’s service coordinator, the representative of the local school system or local lead agency, the representative of the State Department of Education, and the Program shall certify Autism Waiver eligibility and the Program shall establish the effective date for enrollment; or</text> </paragraph> <paragraph num="(b)"> <text>Not to meet all of the criteria specified in §§A—C of this regulation:</text> <paragraph num="(i)"> <text>The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the Autism Waiver eligibility determination; and</text> </paragraph> <paragraph num="(ii)"> <text>The applicant, or the parent or parents of a minor child, shall be informed in writing by the Department for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Every 12 months, or more often if there is a significant change in the participant's condition or needs:</text> <paragraph num="(a)"> <text>The multidisciplinary team and the State Department of Education shall verify whether the participant remains eligible for the Autism Waiver by meeting all of the criteria specified in §§A—C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the redetermination of Autism Waiver eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>If the multidisciplinary team and the State Department of Education verify that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the:</text> <paragraph num="(i)"> <text>Participant's eligibility shall be terminated, as of the effective date established by the multidisciplinary team and the State Department of Education, and</text> </paragraph> <paragraph num="(ii)"> <text>Participant, or the parent or parents of a minor child, shall be informed in writing of the determination, the reason or reasons for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Care Planning Process."> <paragraph num="A."> <text>Multidisciplinary Team.</text> <paragraph num="(1)"> <text>A multidisciplinary team shall be convened by the local school system or local lead agency in accordance with COMAR 10.09.52 to:</text> <paragraph num="(a)"> <text>Assess or reassess an applicant's or participant's need and eligibility for Autism Waiver services;</text> </paragraph> <paragraph num="(b)"> <text>Review the applicant's or participant's IEP or IFSP, as necessary; and</text> </paragraph> <paragraph num="(c)"> <text>Develop or review, and revise as necessary, the applicant's or participant's Autism Waiver plan of care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The multidisciplinary team shall include:</text> <paragraph num="(a)"> <text>The applicant's or participant's service coordinator who shall attend at least one statewide Autism Waiver training session per year;</text> </paragraph> <paragraph num="(b)"> <text>The applicant's or participant's parent or parents;</text> </paragraph> <paragraph num="(c)"> <text>A chairman who is the official representative of the local school system or local lead agency;</text> </paragraph> <paragraph num="(d)"> <text>Other appropriate professionals representing the local school system or local lead agency, as necessary and consistent with the Individuals with Disabilities Education Act (IDEA); and</text> </paragraph> <paragraph num="(e)"> <text>Other service providers and individuals, as appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="A-1."> <text>Risk Assessment.</text> <paragraph num="(1)"> <text>Upon initial review, or if the participant's status changes, the service coordinator shall conduct a risk assessment to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services.</text> </paragraph> <paragraph num="(2)"> <text>A risk assessment shall be conducted by the service coordinator using the Autism Waiver Risk Assessment form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant’s Autism Waiver plan of care or plan of care addendum:</text> <paragraph num="(1)"> <text>Identifies the specific Autism Waiver services to be provided to the participant, as covered under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Specifies for each identified Autism Waiver service the:</text> <paragraph num="(a)"> <text>Description of the specific service to be provided;</text> </paragraph> <paragraph num="(b)"> <text>Service start date;</text> </paragraph> <paragraph num="(c)"> <text>Estimated duration;</text> </paragraph> <paragraph num="(d)"> <text>Approved frequency and units of services to be delivered; and</text> </paragraph> <paragraph num="(e)"> <text>Provider; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Identifies medical conditions that require a written, signed emergency protocol.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Participation — General."> <text>To provide Autism Waiver services, the provider:</text> <paragraph num="A."> <text>Shall be approved in accordance with the requirements specified in this chapter;</text> </paragraph> <paragraph num="B."> <text>Shall have a provider agreement in effect, signed with the Program;</text> </paragraph> <paragraph num="C."> <text>Shall meet all the conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="D."> <text>Shall assure that professional employees who render or delegate services under this chapter have the appropriate experience and health-related license or professional certification to meet the participant's needs, including equivalency review by an accredited agency for credentials obtained outside of the United States, before rendering services to any Autism Waiver participant;</text> </paragraph> <paragraph num="E."> <text>Shall assure that direct care workers who render services under this chapter:</text> <paragraph num="(1)"> <text>Meet the minimum age requirement, set forth by service, before rendering services to any Autism Waiver participant;</text> </paragraph> <paragraph num="(2)"> <text>Receive adequate and appropriate training, within 60 days of employment and annually thereafter, pertaining to care for children with autism spectrum disorder including:</text> <paragraph num="(a)"> <text>Training concerning abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(b)"> <text>Positive behavioral interventions and restraints rendered by a MSDE approved trainer;</text> </paragraph> <paragraph num="(c)"> <text>Reportable event policy; and</text> </paragraph> <paragraph num="(d)"> <text>HIPAA;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Work under the ongoing supervision of a qualified professional employee of the provider who has annual training in:</text> <paragraph num="(a)"> <text>Abuse, neglect, exploitation;</text> </paragraph> <paragraph num="(b)"> <text>Positive behavioral interventions and appropriate use of restraints rendered by a MSDE-approved trainer;</text> </paragraph> <paragraph num="(c)"> <text>Reportable event policy; and</text> </paragraph> <paragraph num="(d)"> <text>HIPAA;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Are approved by the provider as qualified to meet the participant's needs;</text> </paragraph> <paragraph num="(5)"> <text>Are approved by the participant's parents; and</text> </paragraph> <paragraph num="(6)"> <text>Have volunteer or employment experience working with children with autism spectrum disorder or other developmental disabilities as a service provider or as a family member for a minimum of 100 hours, that may include:</text> <paragraph num="(a)"> <text>Internships;</text> </paragraph> <paragraph num="(b)"> <text>Post high school educational experience with developmental disabilities;</text> </paragraph> <paragraph num="(c)"> <text>Shadowing experienced staff;</text> </paragraph> <paragraph num="(d)"> <text>Employment with a developmental disabilities agency; or</text> </paragraph> <paragraph num="(e)"> <text>Fulfilling the community service requirement through volunteering with a child with autism or another developmental disability;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Shall be required to have a professional on-call at all times, and employ or contract with certain professionals for consultation as needed when providing:</text> <paragraph num="(1)"> <text>Residential habilitation services;</text> </paragraph> <paragraph num="(2)"> <text>Intensive individual support services; and</text> </paragraph> <paragraph num="(3)"> <text>Therapeutic integration services;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Shall employ on-call professionals and professional consultants:</text> <paragraph num="(1)"> <text>Who are:</text> <paragraph num="(a)"> <text>Board-certified behavior analysts;</text> </paragraph> <paragraph num="(b)"> <text>Certified school psychologists;</text> </paragraph> <paragraph num="(c)"> <text>Certified special educators;</text> </paragraph> <paragraph num="(d)"> <text>Individuals with a masters or doctorate degree in special education or a related field and 5 years experience in providing training or consultation in autism spectrum disorder or other developmental disabilities;</text> </paragraph> <paragraph num="(e)"> <text>Licensed certified social workers;</text> </paragraph> <paragraph num="(f)"> <text>Licensed professional counselors;</text> </paragraph> <paragraph num="(g)"> <text>Nurse psychotherapists;</text> </paragraph> <paragraph num="(h)"> <text>Physicians;</text> </paragraph> <paragraph num="(i)"> <text>Psychologists;</text> </paragraph> <paragraph num="(j)"> <text>Occupational therapists;</text> </paragraph> <paragraph num="(k)"> <text>Physical therapists;</text> </paragraph> <paragraph num="(l)"> <text>Registered nurses; or</text> </paragraph> <paragraph num="(m)"> <text>Speech therapists; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Who have:</text> <paragraph num="(a)"> <text>Experience providing services to children with autism spectrum disorder or other developmental disabilities;</text> </paragraph> <paragraph num="(b)"> <text>A background in behavior management techniques; and</text> </paragraph> <paragraph num="(c)"> <text>Knowledge of the specific children being served by the provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Shall verify the licenses, credentials, and references of all individuals who render or delegate services on the provider's behalf under this chapter, and have a copy of the licenses, credentials, and at least three written references available for inspection;</text> </paragraph> <paragraph num="I."> <text>Shall maintain current, written, and signed contracts with all contractors providing waiver services on behalf of the provider that include:</text> <paragraph num="(1)"> <text>The scope of services to be performed;</text> </paragraph> <paragraph num="(2)"> <text>The requirement to comply with all applicable Medicaid regulations;</text> </paragraph> <paragraph num="(3)"> <text>The requirement to complete and maintain written documentation of service delivery, individualized for each participant on each day that the participant receives services;</text> </paragraph> <paragraph num="(4)"> <text>A clause that no monies shall be sought from the waiver participant or the participant's family if the contract is breached by either the provider or contractor; and</text> </paragraph> <paragraph num="(5)"> <text>A current copy of a provider license or certification and insurance as required in this chapter;</text> </paragraph> </paragraph> <paragraph num="J."> <text>With the exception of environmental accessibility adaptation providers, shall submit to a preemployment criminal background investigation;</text> </paragraph> <paragraph num="K."> <text>With the exception of respite care and environmental accessibility adaptations providers, shall submit separate, written treatment plans to service coordinators within 30 calendar days of the initiation of services in accordance with State guidelines for each individual service and at least once in each 12-month period thereafter, or more frequently if the treatment plan changes;</text> </paragraph> <paragraph num="L."> <text>If an agency, shall require supervisory and direct care employees of provider agencies to:</text> <paragraph num="(1)"> <text>Submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care; and</text> </paragraph> <paragraph num="(3)"> <text>Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants;</text> </paragraph> </paragraph> <paragraph num="M."> <text>If an agency, shall:</text> <paragraph num="(1)"> <text>Pay for the criminal background check;</text> </paragraph> <paragraph num="(2)"> <text>Request clearance from the Department for all applicants prior to an offer of employment; and</text> </paragraph> <paragraph num="(3)"> <text>Submit monthly Criminal Justice Information System's update reports to the Maryland State Department of Education;</text> </paragraph> </paragraph> <paragraph num="N."> <text>If self-employed, shall:</text> <paragraph num="(1)"> <text>Submit an application for a criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services;</text> </paragraph> <paragraph num="(2)"> <text>Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care;</text> </paragraph> <paragraph num="(3)"> <text>Pay for the criminal background check;</text> </paragraph> <paragraph num="(4)"> <text>Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants; and</text> </paragraph> <paragraph num="(5)"> <text>Submit monthly Criminal Justice Information System’s update reports to the State Department of Education.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Shall have the option to request the Department to waive the provisions of §§L(3) and N(4) of this regulation if the applicant demonstrates that:</text> <paragraph num="(1)"> <text>The conviction, probation before judgment, or plea of nolo contendere for a felony or any crime involving moral turpitude or theft was entered more than 10 years before the date of the provider’s or prospective employee’s application; and</text> </paragraph> <paragraph num="(2)"> <text>The criminal history does not indicate behavior that is potentially harmful to participants;</text> </paragraph> </paragraph> <paragraph num="P."> <text>Shall have adequate liability insurance;</text> </paragraph> <paragraph num="Q."> <text>Shall provide services in accordance with the requirements of the Autism Waiver plan of care, this chapter, the Autism Waiver, and all relevant federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="R."> <text>Shall agree to submit claims for payment by the Program for only those services covered under this chapter which have been identified and documented in a participant's Autism Waiver plan of care;</text> </paragraph> <paragraph num="S."> <text>Shall agree to maintain and have available to the Department or the State Department of Education personnel records and written documentation describing waiver services rendered, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department or its designee;</text> </paragraph> <paragraph num="T."> <text>Shall agree not to suspend, increase, or reduce services for a participant without a waiver plan of care or plan of care addendum from the service coordinator for that participant;</text> </paragraph> <paragraph num="U."> <text>Unless a risk to health and safety exists, shall agree not to terminate services for a participant without providing:</text> <paragraph num="(1)"> <text>30 days written notice to the participant, parent or guardian, and service coordinator; and</text> </paragraph> <paragraph num="(2)"> <text>Assistance in the discharge planning process;</text> </paragraph> </paragraph> <paragraph num="V."> <text>Is not eligible to participate in the waiver if the provider or any of its principals were previously program providers, or if its principals were principals in program providers, that have overpayments that remain due and owing to the Department;</text> </paragraph> <paragraph num="W."> <text>Is not eligible if the provider or its principals within the past 24 months have:</text> <paragraph num="(1)"> <text>Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services;</text> </paragraph> <paragraph num="(2)"> <text>Been suspended or removed from participating as a Medicaid provider;</text> </paragraph> <paragraph num="(3)"> <text>Undergone the imposition of sanctions under COMAR 10.09.36.08;</text> </paragraph> <paragraph num="(4)"> <text>Been subject to disciplinary action including actions by providers or any of its principal's licensing board;</text> </paragraph> <paragraph num="(5)"> <text>Been cited by a State agency for deficiencies which affect a participant's health and safety; or</text> </paragraph> <paragraph num="(6)"> <text>Experienced a termination of a reimbursement agreement with or been barred from work or participation by a public or private agency due to:</text> <paragraph num="(a)"> <text>Failure to meet contractual obligations; or</text> </paragraph> <paragraph num="(b)"> <text>Fraudulent billing practices;</text> </paragraph> </paragraph> </paragraph> <paragraph num="X."> <text>Shall maintain written quarterly records documenting face-to-face supervision of direct care employees and direct observation of the participant that includes:</text> <paragraph num="(1)"> <text>Date and location of supervision;</text> </paragraph> <paragraph num="(2)"> <text>Review, feedback, and oversight of the implementation of treatment plan goals;</text> </paragraph> <paragraph num="(3)"> <text>Review, feedback, and oversight of the implementation of positive behavior intervention;</text> </paragraph> <paragraph num="(4)"> <text>Review, feedback, and oversight of the scope of activities during service;</text> </paragraph> <paragraph num="(5)"> <text>Review, feedback, and oversight of data collection;</text> </paragraph> <paragraph num="(6)"> <text>Date and name of supervisor, name of employee, and name of the participant; and</text> </paragraph> <paragraph num="(7)"> <text>Signature of supervisor;</text> </paragraph> </paragraph> <paragraph num="Y."> <text>Shall agree to keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during business hours;</text> </paragraph> <paragraph num="Z."> <text>Shall implement and follow the Reportable Event policy in accordance with the Department's established policy by:</text> <paragraph num="(1)"> <text>Reporting incidents and complaints to the participant's service coordinator within 24 hours;</text> </paragraph> <paragraph num="(2)"> <text>Submitting a written report within 7 calendar days on a form designated by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subject to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.06.04;</text> </paragraph> </paragraph> <paragraph num="AA."> <text>May not:</text> <paragraph num="(1)"> <text>Render direct services to the provider's own child; or</text> </paragraph> <paragraph num="(2)"> <text>Render supervision to the direct care worker of the provider's own child;</text> </paragraph> </paragraph> <paragraph num="BB."> <text>With the exception of environmental accessibility adaptations providers and residential habilitation providers, shall submit to the service coordinator monthly service tracking forms for each participant served within 20 calendar days of the end of each month;</text> </paragraph> <paragraph num="CC."> <text>With the exception of environmental accessibility adaptations providers, shall attend at least one Autism Waiver training conducted by the State each year and shall participate in:</text> <paragraph num="(1)"> <text>One training annually regarding the prevention, identification, and reporting of abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(2)"> <text>One training annually regarding positive behavioral intervention and restraints; and</text> </paragraph> <paragraph num="(3)"> <text>All statewide Autism Waiver trainings during any year in which the provider is under recommendation for disenrollment from the waiver or has had Medicaid payments suspended;</text> </paragraph> </paragraph> <paragraph num="DD."> <text>Shall satisfactorily complete all aspects of the Autism Waiver provider applications process;</text> </paragraph> <paragraph num="EE."> <text>Shall notify the Program within 15 days of occurrence of any change to contact information;</text> </paragraph> <paragraph num="FF."> <text>Shall maintain communications with the program by maintaining a working telephone and answering machine, facsimile machine, and e-mail account;</text> </paragraph> <paragraph num="GG."> <text>Shall have status as a Maryland Medicaid Autism Waiver provider, including the Medicaid provider number, terminated if no services have been provided for 24 consecutive months;</text> </paragraph> <paragraph num="HH."> <text>Shall, when transportation is provided:</text> <paragraph num="(1)"> <text>Implement the provider’s transportation policy;</text> </paragraph> <paragraph num="(2)"> <text>Identify the driver in daily contact notes or a transportation log;</text> </paragraph> <paragraph num="(3)"> <text>Document the start and stop times transportation is provided for each day that a participant is transported;</text> </paragraph> <paragraph num="(4)"> <text>Maintain a copy of the current automobile liability coverage and documentation of payment for the vehicle transporting a participant; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain a current copy of the valid State driver’s license and driving record for staff transporting a waiver participant; and</text> </paragraph> </paragraph> <paragraph num="II."> <text>Shall comply with all administrative policies, procedures, transmittals, and guidelines issued by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Specific Conditions for Participation — Residential Habilitation Services."> <text>To provide the services covered under Regulation .11 of this chapter, the provider agency shall:</text> <paragraph num="A."> <text>Provide services in a facility that meets the following requirements:</text> <paragraph num="(1)"> <text>Complies with regulations governing residential programs licensed under the:</text> <paragraph num="(a)"> <text>Developmental Disabilities Administration including COMAR 10.22.02 and 10.22.08; or</text> </paragraph> <paragraph num="(b)"> <text>Governor's Office for Children including COMAR 14.31.06;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has eight or fewer beds, unless approved by the State Department of Education to have up to 16 beds due to special needs of children;</text> </paragraph> <paragraph num="(3)"> <text>Has no more than two individuals in a bedroom;</text> </paragraph> <paragraph num="(4)"> <text>Provides opportunities for participants to have personal items in the participant's bedroom that reflect the participant's personal tastes;</text> </paragraph> <paragraph num="(5)"> <text>Provides for input and participation of the participant into eating times, menus, and meal preparation, as appropriate for specific health conditions and in accordance with treatment standards;</text> </paragraph> <paragraph num="(6)"> <text>Provides opportunities for participants to participate in community activities; and</text> </paragraph> <paragraph num="(7)"> <text>Is located and integrated into a residential community.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have at least 3 years of experience in providing habilitation services to children who have autism spectrum disorder or other developmental disabilities;</text> </paragraph> <paragraph num="C."> <text>Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who has either:</text> <paragraph num="(1)"> <text>A valid Maryland certificate as a special education supervisor, principal, or special educator, and at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or</text> </paragraph> <paragraph num="(2)"> <text>At least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Provide round-the-clock staffing which:</text> <paragraph num="(1)"> <text>Includes at all times at least one direct care staff person on site for every three children, with more staffing as necessary based on participants' needs; and</text> </paragraph> <paragraph num="(2)"> <text>Unless the provider designates that it does not provide residential habilitation on weekends, is for 365 days a year,</text> </paragraph> </paragraph> <paragraph num="E."> <text>Have on call 24 hours a day a designated supervisor for the direct care workers, who:</text> <paragraph num="(1)"> <text>Has at least a bachelor's degree in a human services field plus 3 years of experience in the area of autism spectrum disorder or other developmental disabilities, or an associate degree in human services plus 5 years of experience with persons with autism or other developmental disabilities; or</text> </paragraph> <paragraph num="(2)"> <text>Meets the professional guidelines for a qualified intellectual disabilities professional or qualified developmental disabilities professional;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Demonstrate the necessary staff capacity to provide intensive residential habilitation services when needed by participants;</text> </paragraph> <paragraph num="G."> <text>Employ or contract with certain professionals who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter for consultation;</text> </paragraph> <paragraph num="H."> <text>Have at least one professional on call 24 hours a day, 7 days a week for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter;</text> </paragraph> <paragraph num="I."> <text>Demonstrate the capability and capacity of providing Autism Waiver residential habilitation services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding:</text> <paragraph num="(1)"> <text>Abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(2)"> <text>Positive behavior interventions and restraints;</text> </paragraph> <paragraph num="(3)"> <text>Implementation of treatment plans;</text> </paragraph> <paragraph num="(4)"> <text>Transportation of participants;</text> </paragraph> <paragraph num="(5)"> <text>Maintenance of required documentation;</text> </paragraph> <paragraph num="(6)"> <text>Training and supervision of staff;</text> </paragraph> <paragraph num="(7)"> <text>Quality assurance;</text> </paragraph> <paragraph num="(8)"> <text>Emergency back-up plans; and</text> </paragraph> <paragraph num="(9)"> <text>HIPAA;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Assure the provision of services in the least restrictive environment in the community that is appropriate to participants' needs;</text> </paragraph> <paragraph num="K."> <text>Provide documented evidence of integration of the residential habilitation program with other community-based services received by Autism Waiver participants;</text> </paragraph> <paragraph num="L."> <text>Document arrangements for the provision of medical services needed by participants, including helping them to get to medical appointments and to obtain services in an emergency;</text> </paragraph> <paragraph num="M."> <text>For initial approval and as a condition of occupancy of any facility used by the program, submit written documentation from responsible approval or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations;</text> </paragraph> <paragraph num="N."> <text>For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program;</text> </paragraph> <paragraph num="O."> <text>Assure that the participant's needs are met for shelter, food, clothing, and furnishings;</text> </paragraph> <paragraph num="P."> <text>Maintain daily contact logs completed on the same day the service is provided and reflective of the individual plan’s goals and community-based activities from Regulation .11F of this chapter; and</text> </paragraph> <paragraph num="Q."> <text>Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the residential habilitation individual plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for Participation — Intensive Individual Support Services."> <text>To provide the service covered under Regulation .15 of this chapter, the provider shall:</text> <paragraph num="A."> <text>Have at least 3 years of experience in providing habilitation services to children with autism;</text> </paragraph> <paragraph num="B."> <text>Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who shall either:</text> <paragraph num="(1)"> <text>Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or</text> </paragraph> <paragraph num="(2)"> <text>Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter;</text> </paragraph> <paragraph num="D."> <text>Employ or contract with certain professionals for consultation as needed who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter;</text> </paragraph> <paragraph num="E."> <text>Assure supervision of direct care workers by a:</text> <paragraph num="(1)"> <text>Licensed psychologist;</text> </paragraph> <paragraph num="(2)"> <text>Certified school psychologist;</text> </paragraph> <paragraph num="(3)"> <text>Certified special educator;</text> </paragraph> <paragraph num="(4)"> <text>Licensed certified social worker;</text> </paragraph> <paragraph num="(5)"> <text>Licensed professional counselor;</text> </paragraph> <paragraph num="(6)"> <text>Board Certified Behavioral Analyst; or</text> </paragraph> <paragraph num="(7)"> <text>Individual with a masters or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Have at least one professional on call at all times for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter;</text> </paragraph> <paragraph num="G."> <text>Demonstrate the capability and capacity of providing intensive individual support services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding:</text> <paragraph num="(1)"> <text>Abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(2)"> <text>Positive behavior interventions and restraints;</text> </paragraph> <paragraph num="(3)"> <text>Implementation of treatment plans:</text> </paragraph> <paragraph num="(4)"> <text>Emergency backup plans;</text> </paragraph> <paragraph num="(5)"> <text>Transportation of participants;</text> </paragraph> <paragraph num="(6)"> <text>Maintenance of required documentation;</text> </paragraph> <paragraph num="(7)"> <text>Training and supervision of staff;</text> </paragraph> <paragraph num="(8)"> <text>Quality assurance; and</text> </paragraph> <paragraph num="(9)"> <text>HIPAA;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Assure the provision of services in the least restrictive environment in the community that is appropriate to a participant's needs;</text> </paragraph> <paragraph num="I."> <text>Provide documented evidence of integration of the covered services with other community-based services received by Autism Waiver participants;</text> </paragraph> <paragraph num="J."> <text>Document arrangements to obtain medical services for participants in an emergency;</text> </paragraph> <paragraph num="K."> <text>Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service, and at least annually thereafter, or more frequently if the treatment plan changes;</text> </paragraph> <paragraph num="L."> <text>Document goals related to transportation and the participant’s needs on the treatment plan when transportation will be provided;</text> </paragraph> <paragraph num="M."> <text>Maintain daily contact logs completed on the same day the service is provided and reflective of treatment plan goals and activities; and</text> </paragraph> <paragraph num="N."> <text>Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the intensive individual support services treatment plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="Specific Conditions for Participation — Therapeutic Integration Services."> <text>To provide one or more of the services covered under Regulation .14 of this chapter, the provider shall:</text> <paragraph num="A."> <text>Have at least 3 years of experience in providing habilitation services to children with autism spectrum disorder or other developmental disabilities;</text> </paragraph> <paragraph num="B."> <text>Employ a full-time program director to assure adequate coordination and supervision of the covered services, who shall:</text> <paragraph num="(1)"> <text>Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or</text> </paragraph> <paragraph num="(2)"> <text>Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter;</text> </paragraph> <paragraph num="D."> <text>Have on site at least one direct care worker for every three participants on the waiver, with more staffing as necessary based on participants’ needs;</text> </paragraph> <paragraph num="E."> <text>Designate an on-site supervisor for the direct care workers who is:</text> <paragraph num="(1)"> <text>A licensed psychologist;</text> </paragraph> <paragraph num="(2)"> <text>A certified school psychologist;</text> </paragraph> <paragraph num="(3)"> <text>A certified special educator;</text> </paragraph> <paragraph num="(4)"> <text>A licensed certified social worker;</text> </paragraph> <paragraph num="(5)"> <text>A licensed professional counselor;</text> </paragraph> <paragraph num="(6)"> <text>A board-certified behavioral analyst;</text> </paragraph> <paragraph num="(7)"> <text>A licensed or certified as a music, art, drama, dance, or recreation therapist; or</text> </paragraph> <paragraph num="(8)"> <text>An individual with a master's or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Employ or contract with certain professionals for consultation in accordance with Regulation .04G(1) and (2) of this chapter;</text> </paragraph> <paragraph num="G."> <text>Have at least one professional on call at all times for crisis intervention in accordance with Regulation .04G(1) and (2) of this chapter;</text> </paragraph> <paragraph num="H."> <text>Demonstrate the capability and capacity of providing therapeutic integration services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding:</text> <paragraph num="(1)"> <text>Abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(2)"> <text>Positive behavior interventions and restraints;</text> </paragraph> <paragraph num="(3)"> <text>Implementation of treatment plans;</text> </paragraph> <paragraph num="(4)"> <text>Emergency backup plans;</text> </paragraph> <paragraph num="(5)"> <text>Transportation of participants;</text> </paragraph> <paragraph num="(6)"> <text>Maintenance of required documentation;</text> </paragraph> <paragraph num="(7)"> <text>Training and supervision of staff;</text> </paragraph> <paragraph num="(8)"> <text>Quality assurance; and</text> </paragraph> <paragraph num="(9)"> <text>HIPAA;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Provide documented evidence of services in the least restrictive environment in the community that is appropriate to a participant's needs;</text> </paragraph> <paragraph num="J."> <text>Provide documented evidence of integration of the covered services with other community-based services received by participants;</text> </paragraph> <paragraph num="K."> <text>Document arrangements to obtain medical services for participants in an emergency;</text> </paragraph> <paragraph num="L."> <text>For initial approval and as a condition of occupancy of any facility used by the program:</text> <paragraph num="(1)"> <text>Submit written documentation from responsible agency or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations; and</text> </paragraph> <paragraph num="(2)"> <text>Allow an on-site review by the MSDE;</text> </paragraph> </paragraph> <paragraph num="M."> <text>For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program;</text> </paragraph> <paragraph num="N."> <text>Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service and at least annually or more frequently if the treatment plan changes;</text> </paragraph> <paragraph num="O."> <text>Maintain daily contact logs completed on the same day the service is provided and reflective of individual plan goals and activities; and</text> </paragraph> <paragraph num="P."> <text>Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the therapeutic integration treatment plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-2" heading="Specific Conditions for Participation — Intensive Therapeutic Integration Services."> <text>To provide one or more of the services covered under Regulation .14-1 of this chapter, the provider shall:</text> <paragraph num="A."> <text>Meet all the conditions of Regulation .06-1 of this chapter; and</text> </paragraph> <paragraph num="B."> <text>Have an on-site direct care worker for every participant receiving one-to-one intervention for intensive therapeutic integration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for Participation — Respite Care."> <paragraph num="A."> <text>The respite care provider shall have adequate liability insurance and be appropriately bonded.</text> </paragraph> <paragraph num="B."> <text>A professional who provides respite care services or supervises a direct care worker rendering the services shall be:</text> <paragraph num="(1)"> <text>Certified in accordance with COMAR 13A.12.01 as a psychologist or special educator; or</text> </paragraph> <paragraph num="(2)"> <text>Licensed as a psychologist, social worker, registered nurse, professional counselor, or occupational therapist; or</text> </paragraph> <paragraph num="(3)"> <text>A qualified developmental disabilities professional in accordance with COMAR 10.09.26.01B(28);</text> </paragraph> <paragraph num="(4)"> <text>Certified nationally by the Behavior Analyst Certification Board as a Board Certified Behavior Analyst; or</text> </paragraph> <paragraph num="(5)"> <text>An individual with a master's degree or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An agency that provides respite care services shall employ direct care workers who meet qualifications in accordance with Regulation .04E of this chapter.</text> </paragraph> <paragraph num="D."> <text>A respite care provider shall demonstrate the capability and capacity of providing respite care services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding:</text> <paragraph num="(1)"> <text>Abuse, neglect, and exploitation;</text> </paragraph> <paragraph num="(2)"> <text>Positive behavior interventions and restraints;</text> </paragraph> <paragraph num="(3)"> <text>Emergency backup plans;</text> </paragraph> <paragraph num="(4)"> <text>Transportation of participants;</text> </paragraph> <paragraph num="(5)"> <text>Maintenance of required documentation;</text> </paragraph> <paragraph num="(6)"> <text>Training and supervision of staff;</text> </paragraph> <paragraph num="(7)"> <text>Quality assurance; and</text> </paragraph> <paragraph num="(8)"> <text>HIPAA.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation of Service.</text> <paragraph num="(1)"> <text>Maintain daily contact logs completed on the same day the service is provided and reflective of interventions; and</text> </paragraph> <paragraph num="(2)"> <text>Make documentation of services available for review by the State, when requested.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for Participation — Family Consultation."> <paragraph num="A."> <text>To provide the services covered under Regulation .17 of this chapter, a consultant shall be:</text> <paragraph num="(1)"> <text>Certified in accordance with COMAR 13A.12.01 as a psychologist, special educator, or speech therapist;</text> </paragraph> <paragraph num="(2)"> <text>Licensed as a psychologist, certified social worker, nurse psychotherapist, speech therapist, professional counselor, marriage and family therapist, or occupational therapist;</text> </paragraph> <paragraph num="(3)"> <text>Nationally certified as a Board Certified Behavior Analyst; or</text> </paragraph> <paragraph num="(4)"> <text>An individual with a master's or doctorate degree from an accredited university in special education or a related field and have at least 5 years experience providing training or consulting in the area of autism spectrum disorder; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall have training and at least 2 years of experience, which:</text> <paragraph num="(1)"> <text>Is relevant to the family’s needs;</text> </paragraph> <paragraph num="(2)"> <text>Is related to behavior intervention or how to keep the child safe in the home environment; and</text> </paragraph> <paragraph num="(3)"> <text>Was involved with providing services to children with autism spectrum disorder as a service provider or as a family member.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall develop a plan with goals and interventions and submit the plan to the participant’s service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the instructional plan changes.</text> </paragraph> <paragraph num="D."> <text>The provider shall demonstrate the capability and capacity of providing family consultation services by submitting documentation of experience and a written implementation plan.</text> </paragraph> <paragraph num="E."> <text>The provider shall maintain family contact logs completed on the same day the service is provided that are reflective of the family plan, goals and activities.</text> </paragraph> <paragraph num="F."> <text>The provider shall maintain and make available for review by the State, documentation of the 6-month review and update the status relative to each goal in the family plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Specific Conditions for Participation — Environmental Accessibility Adaptations."> <text>To provide the services covered under Regulation .18 of this chapter, the provider shall:</text> <paragraph num="A."> <text>Be the store, vendor, contractor, or builder from which the adaptation is purchased;</text> </paragraph> <paragraph num="B."> <text>Be able to install the adaptation, if necessary;</text> </paragraph> <paragraph num="C."> <text>Be able to service or maintain the adaptation, as necessary; and</text> </paragraph> <paragraph num="D."> <text>If construction is involved:</text> <paragraph num="(1)"> <text>Have the appropriate State license as a contractor or builder; and</text> </paragraph> <paragraph num="(2)"> <text>Be appropriately and adequately bonded.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Specific Conditions for Participation — Adult Life Planning Services."> <paragraph num="A."> <text>To provide the services covered under Regulation .19 of this chapter, the provider shall:</text> <paragraph num="(1)"> <text>Be an individual with a bachelor’s degree; and</text> </paragraph> <paragraph num="(2)"> <text>Have 3 years of full-time experience serving adults with autism disabilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Adult life planning service providers shall work with the participants and the participants families to develop a treatment plan incorporating the principles of self-determination, person-centered planning, decision making, and planning for adulthood.</text> </paragraph> <paragraph num="C."> <text>The provider shall submit the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the plan changes.</text> </paragraph> <paragraph num="D."> <text>At the completion of each year of adult life planning services, the provider shall provide a report of documented evidence of progress towards self-determination, community integration, and coordination with adult services.</text> </paragraph> <paragraph num="E."> <text>The provider shall maintain Adult Life Planning contact logs completed on the same day the service is provided and reflective of the Adult Life Planning treatment plan goals and activities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Services — Residential Habilitation Services."> <paragraph num="A."> <text>The Program under this regulation does not cover the following:</text> <paragraph num="(1)"> <text>Any Medicaid State Plan services which are provided by medical professionals employed by or under contract with the residential habilitation provider;</text> </paragraph> <paragraph num="(2)"> <text>Room and board;</text> </paragraph> <paragraph num="(3)"> <text>Direct or indirect payments to the participant's immediate family;</text> </paragraph> <paragraph num="(4)"> <text>Routine care and supervision which a family is expected to provide;</text> </paragraph> <paragraph num="(5)"> <text>Activities or supervision reimbursed by a source other than Medicaid; and</text> </paragraph> <paragraph num="(6)"> <text>The facility's maintenance, upkeep, and improvement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The residential habilitation program shall:</text> <paragraph num="(1)"> <text>Provide community-based, intensive residential placements for participants who cannot live at home at the present time because they require highly supervised and supportive environments;</text> </paragraph> <paragraph num="(2)"> <text>Provide a home-like, safe, 24-hour, therapeutic living environment of treatment, intervention, training, supportive care, and oversight;</text> </paragraph> <paragraph num="(3)"> <text>Be designed to assist Autism Waiver participants in acquiring, retaining, and improving the self-help, socialization, and adaptive skills necessary to reside successfully in home and community-based settings;</text> </paragraph> <paragraph num="(4)"> <text>Work closely with the participant's service coordinator to provide transition services for each participant in placement to allow, as appropriate, for the:</text> <paragraph num="(a)"> <text>Participant's eventual return to the family (natural, adoptive, or surrogate); or</text> </paragraph> <paragraph num="(b)"> <text>Participant to acquire the skills and resources for group or independent living; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Coordinate with the participant's educational, health, and medical service providers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A participant's placement in residential habilitation services shall be:</text> <paragraph num="(1)"> <text>Preauthorized by the multidisciplinary team; and</text> </paragraph> <paragraph num="(2)"> <text>Reviewed by the multidisciplinary team at least annually.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Residential habilitation services shall be received in facilities located in the State which are:</text> <paragraph num="(1)"> <text>Licensed group homes;</text> </paragraph> <paragraph num="(2)"> <text>Licensed alternative living units; or</text> </paragraph> <paragraph num="(3)"> <text>Community-based residential facilities approved by the State Department of Education for special education services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Intensity Levels.</text> <paragraph num="(1)"> <text>Residential habilitation services are provided and reimbursed at a regular or intensive level for a participant.</text> </paragraph> <paragraph num="(2)"> <text>To be approved by the multidisciplinary team for the intensive level of residential habilitation services, the participant must need:</text> <paragraph num="(a)"> <text>Awake overnight staffing; and</text> </paragraph> <paragraph num="(b)"> <text>At minimum, 4 hours of one-on-one staffing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Services.</text> <paragraph num="(1)"> <text>A residential habilitation program shall provide all of the services listed in §F(2)—(12) of this regulation, as necessary for the participant.</text> </paragraph> <paragraph num="(2)"> <text>Habilitation. The residential rehabilitation program shall provide training to assist a participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the ability to reside as independently as possible.</text> </paragraph> <paragraph num="(3)"> <text>Behavior Shaping and Management. The residential rehabilitation program shall train, supervise, and assist the participant, which may include psychiatric or psychological interventions, in appropriate communication and expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and reduction of inappropriate behaviors.</text> </paragraph> <paragraph num="(4)"> <text>Daily Living Skills. The residential rehabilitation program shall train or assist the participant in dressing, personal hygiene, self-administration of medications, proper use of appliances and adaptive or assistive devices, home safety, first aid, and emergency procedures.</text> </paragraph> <paragraph num="(5)"> <text>Self-Direction. The residential rehabilitation program shall train the participant in identifying and responding to dangerous or threatening situations, making decisions and choices affecting the participant's life, and initiating changes in living arrangements or life activities.</text> </paragraph> <paragraph num="(6)"> <text>Functional Living Skills Training. The residential rehabilitation program shall train the participant in self-reliance, money management, and money handling and purchases.</text> </paragraph> <paragraph num="(7)"> <text>Socialization. The residential rehabilitation program shall train, supervise, or assist the participant to facilitate the participant's involvement in general community activities and establishment of relationships with peers, which may:</text> <paragraph num="(a)"> <text>Not include participation in activities which are solely diversional or recreational in nature; and</text> </paragraph> <paragraph num="(b)"> <text>Include:</text> <paragraph num="(i)"> <text>Assisting the participant with learning and practicing skills of cooperation and participation;</text> </paragraph> <paragraph num="(ii)"> <text>Assisting the participant to identify and participate in activities of interest; and</text> </paragraph> <paragraph num="(iii)"> <text>Providing specific training activities necessary to assist the participant to participate in activities of interest on an ongoing basis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Mobility. The residential rehabilitation program shall train, supervise, and assist the participant to:</text> <paragraph num="(a)"> <text>Enhance movement within the participant's living, working, or education environment;</text> </paragraph> <paragraph num="(b)"> <text>Master the use of adaptive aids and equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Access and use public transportation, independent travel, or other movement within the community.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Transportation. The residential rehabilitation program shall provide transportation for the participant to recreation, leisure activities, or skills training.</text> </paragraph> <paragraph num="(10)"> <text>Crisis Intervention and Planning. The residential rehabilitation program shall include:</text> <paragraph num="(a)"> <text>Planning for crises in the participant's residential habilitation placement; and</text> </paragraph> <paragraph num="(b)"> <text>Making the necessary behavioral or environmental interventions to stabilize and preserve the participant's residential habilitation placement, or resolve an intensive behavioral episode.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Medication Management, Monitoring, and Training. The residential rehabilitation program shall provide, as needed and appropriate, medication management, monitoring, and training in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11.</text> </paragraph> <paragraph num="(12)"> <text>Transition Services. The residential rehabilitation program shall provide training and experiential learning activities for a participant in a residential habilitation placement, which:</text> <paragraph num="(a)"> <text>Assist with developing discharge planning goals for the participant;</text> </paragraph> <paragraph num="(b)"> <text>Assist the participant in making the transition to home, the next planned placement, or independent living;</text> </paragraph> <paragraph num="(c)"> <text>Are responsive to the participant's individualized developmental and behavioral needs; and</text> </paragraph> <paragraph num="(d)"> <text>Promote self-reliance and age-appropriate behavior.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A supervisor who has been trained in accordance with Regulation .04E(3) of this chapter shall:</text> <paragraph num="(1)"> <text>Train and provide ongoing supervision to the direct care worker rendering residential habilitation services;</text> </paragraph> <paragraph num="(2)"> <text>Supervise the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervene to reduce the likelihood of reoccurrence;</text> </paragraph> <paragraph num="(3)"> <text>Plan and regularly review the participant’s therapeutic activities and behavior plan;</text> </paragraph> <paragraph num="(4)"> <text>Meet regularly with the participant and family and observe the participant in the residential habilitation setting; and</text> </paragraph> <paragraph num="(5)"> <text>Develop and identify on the individualized treatment plan, the goals, interventions, and tasks that the residential habilitation direct care worker is implementing.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A unit of service for residential habilitation shall be on a per diem basis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Repealed." /> <regulation prefix="Regulation" num=".13" heading="Repealed." /> <regulation prefix="Regulation" num=".14" heading="Covered Services — Therapeutic Integration Services."> <paragraph num="A."> <text>Therapeutic integration services under this regulation:</text> <paragraph num="(1)"> <text>Are provided at a nonresidential setting separate from the home or facility where the participant lives;</text> </paragraph> <paragraph num="(2)"> <text>Focus on expressive therapies and therapeutic recreational activities;</text> </paragraph> <paragraph num="(3)"> <text>Include as important components the development of socialization skills, enhancement of self-esteem, and behavior management;</text> </paragraph> <paragraph num="(4)"> <text>Are especially needed for participants who have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders;</text> </paragraph> <paragraph num="(5)"> <text>Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes;</text> </paragraph> <paragraph num="(6)"> <text>Shall be culturally competent and congruent with the participant's cultural norms;</text> </paragraph> <paragraph num="(7)"> <text>May include individual or group counseling;</text> </paragraph> <paragraph num="(8)"> <text>Shall assure coordination with the participant's other service providers, service coordinator, and multidisciplinary team;</text> </paragraph> <paragraph num="(9)"> <text>Shall be guided by the participant's individualized treatment plan;</text> </paragraph> <paragraph num="(10)"> <text>Shall be based on an individualized written plan that identifies goals of the specific therapeutic activities provided;</text> </paragraph> <paragraph num="(11)"> <text>Shall provide:</text> <paragraph num="(a)"> <text>General therapeutic and therapeutic recreational services;</text> </paragraph> <paragraph num="(b)"> <text>Behavioral management;</text> </paragraph> <paragraph num="(c)"> <text>Planning for crises with the participant during a session;</text> </paragraph> <paragraph num="(d)"> <text>Socialization groups; and</text> </paragraph> <paragraph num="(e)"> <text>One or more of art, music, dance, or activity therapies, as appropriate for participants;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that:</text> <paragraph num="(a)"> <text>Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services;</text> </paragraph> <paragraph num="(b)"> <text>Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence;</text> </paragraph> <paragraph num="(c)"> <text>Plans and regularly reviews the participant’s therapeutic activities and behavior plan;</text> </paragraph> <paragraph num="(d)"> <text>Meets regularly with the participant and family and observes the participant in the community setting; and</text> </paragraph> <paragraph num="(e)"> <text>Develops and identifies, on the individualized treatment plan, the goals, interventions, and tasks that the therapeutic integration direct care worker is implementing;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Shall, when transportation is provided:</text> <paragraph num="(a)"> <text>Have individualized goals for transportation for the participant on the participant’s treatment plan; and</text> </paragraph> <paragraph num="(b)"> <text>Document the start and stop times transportation is provided for each day that a participant is transported;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting.</text> </paragraph> <paragraph num="C."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14-1" heading="Covered Services — Intensive Therapeutic Integration Services."> <paragraph num="A."> <text>Intensive therapeutic integration services under this regulation:</text> <paragraph num="(1)"> <text>Are provided at a nonresidential setting separate from the home or facility where the participant lives;</text> </paragraph> <paragraph num="(2)"> <text>Shall have an on-site direct care worker for every participant receiving one-to-one interventions for intensive therapeutic integration;</text> </paragraph> <paragraph num="(3)"> <text>Shall include expressive therapies and therapeutic recreational activities;</text> </paragraph> <paragraph num="(4)"> <text>Shall include the development of socialization skills, enhancement of self-esteem, and behavior management;</text> </paragraph> <paragraph num="(5)"> <text>Are for participants who require one-to-one interventions and also have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders;</text> </paragraph> <paragraph num="(6)"> <text>Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes;</text> </paragraph> <paragraph num="(7)"> <text>Shall be culturally competent and congruent with the participant’s cultural norms;</text> </paragraph> <paragraph num="(8)"> <text>Shall assure coordination with the participant’s other service providers, service coordinator, and multidisciplinary team;</text> </paragraph> <paragraph num="(9)"> <text>Shall be based on the participant’s individualized written treatment plan that identifies goals of the specific therapeutic activities provided;</text> </paragraph> <paragraph num="(10)"> <text>Shall provide:</text> <paragraph num="(a)"> <text>General therapeutic and therapeutic recreational services;</text> </paragraph> <paragraph num="(b)"> <text>Behavioral management;</text> </paragraph> <paragraph num="(c)"> <text>Planning for crises with the participant during a session;</text> </paragraph> <paragraph num="(d)"> <text>Socialization groups; and</text> </paragraph> <paragraph num="(e)"> <text>One or more of art, music, dance, or activity therapies, as appropriate for participants;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that:</text> <paragraph num="(a)"> <text>Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services;</text> </paragraph> <paragraph num="(b)"> <text>Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence;</text> </paragraph> <paragraph num="(c)"> <text>Plans and regularly reviews the participant’s therapeutic activities and behavior plan;</text> </paragraph> <paragraph num="(d)"> <text>Meets regularly with the participant and family and observes the participant in the community setting;</text> </paragraph> <paragraph num="(e)"> <text>Develops intervention on an individualized basis and identifies the interventions on an individualized treatment plan; and</text> </paragraph> <paragraph num="(f)"> <text>Identifies, in the treatment plan, the goals and tasks that the intensive therapeutic integration direct care worker is implementing; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Shall, when transportation is provided:</text> <paragraph num="(a)"> <text>Have individualized goals for transportation for the participant on the participant’s treatment plan; and</text> </paragraph> <paragraph num="(b)"> <text>Document the start and stop times transportation is provided for each day that a participant is transported.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting.</text> </paragraph> <paragraph num="C."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Covered Services — Intensive Individual Support Services."> <paragraph num="A."> <text>Intensive individual support services:</text> <paragraph num="(1)"> <text>Are intensive, one-on-one interventions with the participant provided by a direct care worker;</text> </paragraph> <paragraph num="(2)"> <text>May be received by the participant on a long-term basis;</text> </paragraph> <paragraph num="(3)"> <text>Are authorized in the participant's Autism Waiver plan of care if the participant's behavior without this intervention would require a more restrictive residential or treatment setting;</text> </paragraph> <paragraph num="(4)"> <text>May be provided in the participant's home or another setting except a residential or youth camp facility;</text> </paragraph> <paragraph num="(5)"> <text>May be provided by more than one direct care worker necessitating ongoing coordination between the direct care workers;</text> </paragraph> <paragraph num="(6)"> <text>Are goal-oriented and task-oriented, with interventions developed on an individualized basis based on the participant's individualized treatment plan;</text> </paragraph> <paragraph num="(7)"> <text>Use the home and community environment as a learning experience and opportunity to illustrate and model alternative ways for the participant to behave;</text> </paragraph> <paragraph num="(8)"> <text>Assist the participant in achieving successful home and community living through structured support, reinforcement, modeling, and behavior management, as evidenced in written progress notes;</text> </paragraph> <paragraph num="(9)"> <text>Shall, when transportation is provided:</text> <paragraph num="(a)"> <text>Have individualized goals for transportation for the participant on the participant's plan; and</text> </paragraph> <paragraph num="(b)"> <text>Document the start and stop times transportation is provided for each day that a participant is transported;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Are intended to:</text> <paragraph num="(a)"> <text>Prevent or defuse crises;</text> </paragraph> <paragraph num="(b)"> <text>Promote developmental and social skills growth;</text> </paragraph> <paragraph num="(c)"> <text>Provide the participant with behavior management skills;</text> </paragraph> <paragraph num="(d)"> <text>Give the participant a sense of security and safety;</text> </paragraph> <paragraph num="(e)"> <text>Assist the participant with maintaining self-sufficiency and impulse control;</text> </paragraph> <paragraph num="(f)"> <text>Improve the participant's positive self-expression and interpersonal communication;</text> </paragraph> <paragraph num="(g)"> <text>Improve the participant's ability to function and cooperate in the home and community;</text> </paragraph> <paragraph num="(h)"> <text>Reverse negative behaviors and attitudes; and</text> </paragraph> <paragraph num="(i)"> <text>Foster stabilization; and</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Include:</text> <paragraph num="(a)"> <text>One-on-one support, assistance, oversight, and intervention;</text> </paragraph> <paragraph num="(b)"> <text>Time-structuring activities;</text> </paragraph> <paragraph num="(c)"> <text>Immediate behavioral reinforcements;</text> </paragraph> <paragraph num="(d)"> <text>Time-out strategies; and</text> </paragraph> <paragraph num="(e)"> <text>Crisis intervention techniques.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Direct care workers and supervisors rendering intensive individual support services shall collaborate with the participant's family, providers of other waiver services, and other professionals working with the participant in the home or other community settings, including the schools.</text> </paragraph> <paragraph num="C."> <text>A professional who meets the provider qualifications of Regulation .04G(1)(a)—(f) of this chapter shall:</text> <paragraph num="(1)"> <text>Train and provide ongoing supervision to the direct care worker rendering intensive individual support services;</text> </paragraph> <paragraph num="(2)"> <text>Supervise the direct care worker when crisis intervention services are rendered, to evaluate the nature of the crisis and intervene as necessary to reduce the likelihood of reoccurrence;</text> </paragraph> <paragraph num="(3)"> <text>Plan and regularly review the participant's therapeutic activities and behavior plans;</text> </paragraph> <paragraph num="(4)"> <text>Meet regularly with the participant and family and observe the participant in the home setting;</text> </paragraph> <paragraph num="(5)"> <text>Develop intervention on an individualized basis and identify the interventions on an individualized treatment plan; and</text> </paragraph> <paragraph num="(6)"> <text>Identify in the treatment plan goals and tasks that the intensive individual support services direct care worker is implementing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="E."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Covered Services — Respite Care."> <paragraph num="A."> <text>Respite care:</text> <paragraph num="(1)"> <text>Shall consist of one-on-one interventions with the participant;</text> </paragraph> <paragraph num="(2)"> <text>Shall be rendered by a qualified:</text> <paragraph num="(a)"> <text>Professional who meets the qualifications in Regulation .07B of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Direct care worker who is supervised by a qualified professional;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Shall include assistance with activities of daily living provided to participants who are unable to care for themselves;</text> </paragraph> <paragraph num="(4)"> <text>Shall be furnished on a short-term basis because of the absence of or need for relief of the participant's family that normally provides the care;</text> </paragraph> <paragraph num="(5)"> <text>Shall be provided in the participant's home or place of residence, or community setting, not including a residential habilitation facility;</text> </paragraph> <paragraph num="(6)"> <text>May be provided in a youth camp certified by the Maryland Department of Health under COMAR 10.16.06; and</text> </paragraph> <paragraph num="(7)"> <text>May be provided in a site licensed to accommodate individuals for respite care by the Developmental Disabilities Administration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Respite care may not:</text> <paragraph num="(1)"> <text>Be available for participants receiving residential habilitation services;</text> </paragraph> <paragraph num="(2)"> <text>Include the direct care worker's or the participant's room and board; or</text> </paragraph> <paragraph num="(3)"> <text>Be rendered by a participant's parent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="D."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Covered Services — Family Consultation."> <paragraph num="A."> <text>Family consultation shall be provided as specified in the family consultation plan, and:</text> <paragraph num="(1)"> <text>Shall be based on family-oriented goals to benefit the participant;</text> </paragraph> <paragraph num="(2)"> <text>Shall be provided to one family at a time;</text> </paragraph> <paragraph num="(3)"> <text>May not include advocacy regarding a participant's IEP; and</text> </paragraph> <paragraph num="(4)"> <text>May not include training and supervision of direct care workers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant's family:</text> <paragraph num="(1)"> <text>Shall be trained by a qualified licensed or certified professional to provide intensive one-on-one interventions with the participant;</text> </paragraph> <paragraph num="(2)"> <text>May be instructed in the treatment regimens, behavior intervention and modeling, skills training, and use of equipment specified in the participant's Autism Waiver plan of care;</text> </paragraph> <paragraph num="(3)"> <text>Shall be provided with training updates as necessary to maintain the participant safely at home; and</text> </paragraph> <paragraph num="(4)"> <text>Shall be present to receive family consultation services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Services.</text> <paragraph num="(1)"> <text>A participant’s family shall receive in-person, individualized consultation when providing the habilitation services listed in §C(2)—(8) of this regulation, as necessary for the participant.</text> </paragraph> <paragraph num="(2)"> <text>Habilitation. The participant’s family shall receive consultation to assist the participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the participant’s development and ability to reside as independently as possible, including communication skills.</text> </paragraph> <paragraph num="(3)"> <text>Self-Direction. The participant’s family shall receive consultation to assist the participant in:</text> <paragraph num="(a)"> <text>Identifying and responding to dangerous or threatening situations;</text> </paragraph> <paragraph num="(b)"> <text>Making decisions and choices affecting the participant's life; and</text> </paragraph> <paragraph num="(c)"> <text>Initiating changes in living arrangements or life activities, as appropriate.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Behavior Shaping and Management. The participant’s family shall receive consultation to assist the participant with appropriate expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and the reduction of inappropriate behaviors.</text> </paragraph> <paragraph num="(5)"> <text>Daily Living Skills. The participant’s family shall receive consultation to assist the participant, as appropriate, in:</text> <paragraph num="(a)"> <text>Dressing;</text> </paragraph> <paragraph num="(b)"> <text>Eating;</text> </paragraph> <paragraph num="(c)"> <text>Personal hygiene;</text> </paragraph> <paragraph num="(d)"> <text>Self-administration of medications;</text> </paragraph> <paragraph num="(e)"> <text>Proper use of appliances and adaptive or assistive devices;</text> </paragraph> <paragraph num="(f)"> <text>Home safety;</text> </paragraph> <paragraph num="(g)"> <text>First aid; and</text> </paragraph> <paragraph num="(h)"> <text>Emergency procedures.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Socialization. The participant’s family shall receive consultation which facilitates the participant’s involvement in family and community activities and establishing relationships with siblings and peers, which may include:</text> <paragraph num="(a)"> <text>Assisting the participant to identify activities of interest;</text> </paragraph> <paragraph num="(b)"> <text>Arranging for participation in those activities; and</text> </paragraph> <paragraph num="(c)"> <text>Identifying specific interventions necessary to assist the participant’s involvement in those activities on an ongoing basis.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Mobility. The participant’s family shall receive consultation to assist the participant with:</text> <paragraph num="(a)"> <text>Enhancing movement within the participant's living arrangement;</text> </paragraph> <paragraph num="(b)"> <text>Mastering the use of adaptive aids and equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Accessing and using public transportation, independent travel, or other movement within the community.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Money Management. The participant’s family shall receive consultation to assist the participant with:</text> <paragraph num="(a)"> <text>Handling personal finances;</text> </paragraph> <paragraph num="(b)"> <text>Making purchases; and</text> </paragraph> <paragraph num="(c)"> <text>Meeting personal financial obligations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Family consultation does not include activities that are not covered under §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="F."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Covered Services — Environmental Accessibility Adaptations."> <paragraph num="A."> <text>Environmental accessibility adaptations are those physical adaptations to the participant's home, which are reasonable and medically necessary to:</text> <paragraph num="(1)"> <text>Prevent the participant's institutionalization;</text> </paragraph> <paragraph num="(2)"> <text>Assure:</text> <paragraph num="(a)"> <text>The participant's health, welfare, and safety; and</text> </paragraph> <paragraph num="(b)"> <text>A safe, therapeutic environment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prevent the participant's self-injurious behavior; and</text> </paragraph> <paragraph num="(4)"> <text>Enable the participant to function with greater independence in the home.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Environmental accessibility adaptations include:</text> <paragraph num="(1)"> <text>Alarms or locks on doors, windows, or fences;</text> </paragraph> <paragraph num="(2)"> <text>Protective padding on walls or floors;</text> </paragraph> <paragraph num="(3)"> <text>Plexiglass on windows;</text> </paragraph> <paragraph num="(4)"> <text>Outside gates and fences;</text> </paragraph> <paragraph num="(5)"> <text>Brackets for appliances;</text> </paragraph> <paragraph num="(6)"> <text>Raised electrical switches and sockets;</text> </paragraph> <paragraph num="(7)"> <text>Safety screen doors; and</text> </paragraph> <paragraph num="(8)"> <text>Individual tracking devices.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The environmental accessibility adaptations shall be preauthorized in the participant's plan of care and by the State Department of Education.</text> </paragraph> <paragraph num="D."> <text>All construction shall:</text> <paragraph num="(1)"> <text>Be provided in accordance with applicable State or local building codes; and</text> </paragraph> <paragraph num="(2)"> <text>Pass the required inspections.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Window locks may only be used if there is no other way to prevent a participant's rapid movement into a potentially dangerous situation.</text> </paragraph> <paragraph num="F."> <text>With the added safety precautions, it shall be assured that the house has enough exits, so there are not fire or safety concerns.</text> </paragraph> <paragraph num="G."> <text>Several rooms may be secured, but not the whole house.</text> </paragraph> <paragraph num="H."> <text>As appropriate, the adaptations shall be approved by the fire department or fire marshal as meeting the fire safety requirements.</text> </paragraph> <paragraph num="I."> <text>This service is not covered for facilities where residential habilitation services are delivered.</text> </paragraph> <paragraph num="J."> <text>Excluded are those adaptations or improvements to the home, such as carpeting, roof repair, and central air conditioning, which:</text> <paragraph num="(1)"> <text>Are of general utility;</text> </paragraph> <paragraph num="(2)"> <text>Are not of direct medical or remedial benefit to the participant; or</text> </paragraph> <paragraph num="(3)"> <text>Add to the home's total square footage.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Covered Services — Adult Life Planning Services."> <paragraph num="A."> <text>Adult life planning services shall be provided as specified in the adult life planning treatment plan.</text> </paragraph> <paragraph num="B."> <text>Adult life planning services shall:</text> <paragraph num="(1)"> <text>Result in the participant's transition from Autism Waiver services to comparable, necessary adult life services;</text> </paragraph> <paragraph num="(2)"> <text>Be based on the participant's need for services and support after disenrollment from the Autism Waiver; and</text> </paragraph> <paragraph num="(3)"> <text>Be provided only to participants age 14 years old or older.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="D."> <text>For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Conditions for Reimbursement."> <text>The Department shall reimburse for services under this chapter when the services are:</text> <paragraph num="A."> <text>Provided to a participant who meets the qualifications for eligibility specified in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Preauthorized in the participant's plan of care by the State Department of Education and the multidisciplinary team, as being reasonable and medically necessary to prevent institutionalization;</text> </paragraph> <paragraph num="C."> <text>Provided by an approved provider which meets the conditions for participation of this chapter; and</text> </paragraph> <paragraph num="D."> <text>Rendered pursuant to:</text> <paragraph num="(1)"> <text>The relevant definition of covered services in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>All other requirements specified in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>The Autism Waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Limitations."> <paragraph num="A."> <text>Reimbursement may be made by the Program only when all of the requirements of this chapter are met.</text> </paragraph> <paragraph num="B."> <text>Residential habilitation services may not be reimbursed for the same date of service as intensive individual support services, therapeutic integration services, intensive therapeutic integration services, or respite care.</text> </paragraph> <paragraph num="C."> <text>Therapeutic integration services, intensive therapeutic integration services, and intensive individual support services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the same day.</text> </paragraph> <paragraph num="D."> <text>Therapeutic integration and intensive therapeutic integration services may not be rendered during the same week to a participant.</text> </paragraph> <paragraph num="E."> <text>Therapeutic integration and intensive therapeutic integration services may include transportation time when at least 2 units of service have been provided on-site, and the maximum units of service billed may not exceed 12 units.</text> <paragraph num="(1)"> <text>For dates of service before July 1, 2023, 24 units; or</text> </paragraph> <paragraph num="(2)"> <text>For dates of service on or after July 1, 2023, 12 units.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Environmental accessibility adaptations may be reimbursed only if preauthorized by the State Department of Education.</text> </paragraph> <paragraph num="G."> <text>If an environmental accessibility adaptation is anticipated to cost over $500, at least two bids or prices shall be obtained, based on which the State Department of Education may approve the purchase.</text> </paragraph> <paragraph num="H."> <text>The Program may reimburse for a participant not more than:</text> <paragraph num="(1)"> <text>For dates of service before July 1, 2023:</text> <paragraph num="(a)"> <text>1 unit per date of service for residential habilitation services at either the regular or intensive level;</text> </paragraph> <paragraph num="(b)"> <text>40 units of therapeutic integration services per week;</text> </paragraph> <paragraph num="(c)"> <text>30 units of intensive therapeutic integration services per week;</text> </paragraph> <paragraph num="(d)"> <text>12 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service;</text> </paragraph> <paragraph num="(e)"> <text>50 units of intensive individual support services per week;</text> </paragraph> <paragraph num="(f)"> <text>48 units of respite care for a date of service;</text> </paragraph> <paragraph num="(g)"> <text>672 units of respite care per State fiscal year;</text> </paragraph> <paragraph num="(h)"> <text>12 units of family consultation for a date of service;</text> </paragraph> <paragraph num="(i)"> <text>80 units of family consultation per State fiscal year;</text> </paragraph> <paragraph num="(j)"> <text>A total of $2,000 for environmental accessibility adaptations over a 36-month period;</text> </paragraph> <paragraph num="(k)"> <text>16 units of intensive individual support services per day;</text> </paragraph> <paragraph num="(l)"> <text>30 units of adult life planning services per State fiscal year, for participants 16 years old or older;</text> </paragraph> <paragraph num="(m)"> <text>A lifetime maximum of 90 units of adult life planning services per participant, for participants 16 years old or older; and</text> </paragraph> <paragraph num="(n)"> <text>15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For dates of service on or after July 1, 2023:</text> <paragraph num="(a)"> <text>1 unit per date of service for residential habilitation services at either the regular or the intensive level;</text> </paragraph> <paragraph num="(b)"> <text>80 units of therapeutic integration services per week;</text> </paragraph> <paragraph num="(c)"> <text>60 units of intensive therapeutic integration services per week;</text> </paragraph> <paragraph num="(d)"> <text>24 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service;</text> </paragraph> <paragraph num="(e)"> <text>160 units of intensive individual support services per week;</text> </paragraph> <paragraph num="(f)"> <text>96 units of respite care for a date of service;</text> </paragraph> <paragraph num="(g)"> <text>1344 units of respite care per State fiscal year;</text> </paragraph> <paragraph num="(h)"> <text>24 units of family consultation for a date of service;</text> </paragraph> <paragraph num="(i)"> <text>160 units of family consultation per State fiscal year;</text> </paragraph> <paragraph num="(j)"> <text>A total of $2,104 for environmental accessibility adaptations over a 36-month period;</text> </paragraph> <paragraph num="(k)"> <text>32 units of intensive individual support services per day;</text> </paragraph> <paragraph num="(l)"> <text>80 units of adult life planning services per State fiscal year, for participants 14 years old or older;</text> </paragraph> <paragraph num="(m)"> <text>16 units of adult life planning services per date of service, for participants 14 years old or older; and</text> </paragraph> <paragraph num="(n)"> <text>15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Respite services may not be reimbursed for the same period of the same day as:</text> <paragraph num="(1)"> <text>Residential habilitation;</text> </paragraph> <paragraph num="(2)"> <text>Intensive individual support services;</text> </paragraph> <paragraph num="(3)"> <text>Family consultation;</text> </paragraph> <paragraph num="(4)"> <text>Therapeutic integration;</text> </paragraph> <paragraph num="(5)"> <text>Intensive therapeutic integration; or</text> </paragraph> <paragraph num="(6)"> <text>Adult life planning services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Program does not reimburse transportation costs such as gas, maintenance, or other vehicle operating expenses.</text> </paragraph> <paragraph num="K."> <text>Adult life planning services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the day.</text> </paragraph> <paragraph num="L."> <text>The Program does not reimburse for any autism waiver services for a participant whose residential placement in a 24-hour, 365-day residential program is funded with non-Medicaid federal, State, or local government funds.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04 or otherwise established by the Program.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall:</text> <paragraph num="(a)"> <text>Bill the Program in accordance with the payment methodology specified in §§D and E of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party for these services; and</text> </paragraph> <paragraph num="(c)"> <text>Submit a request for payment in a manner approved by the Program, which includes the:</text> <paragraph num="(i)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(ii)"> <text>Participant's name and Medicaid number;</text> </paragraph> <paragraph num="(iii)"> <text>Provider's name, location, and Program identification number;</text> </paragraph> <paragraph num="(iv)"> <text>Type, procedure code or codes, and unit or units of covered services provided; and</text> </paragraph> <paragraph num="(v)"> <text>Amount of reimbursement requested.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Documentation Required.</text> <paragraph num="(1)"> <text>Payments by the Program or its designee may be withheld if the provider fails to submit requested evidence of services provided, staff qualifications, corrective action plans, or other types of documentation related to ensuring the health and safety of a participant.</text> </paragraph> <paragraph num="(2)"> <text>Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation.</text> </paragraph> <paragraph num="(3)"> <text>An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant.</text> </paragraph> <paragraph num="(2)"> <text>Providers shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established according to the fee schedule published by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Rates.</text> <paragraph num="(1)"> <text>The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026.</text> </paragraph> <paragraph num="(3)"> <text>Effective July 1, 2022, the Program shall pay according to the following fee-for-service schedule:</text> <paragraph num="(a)"> <text>Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant:</text> <paragraph num="(i)"> <text>$283.69 per unit for the regular level of service; or</text> </paragraph> <paragraph num="(ii)"> <text>$567.45 per unit for the intensive level of service.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Therapeutic integration services reimbursed at the maximum rate of $17.19 per unit.</text> </paragraph> <paragraph num="(c)"> <text>Intensive therapeutic integration services reimbursed at the maximum rate of $21.49 per unit.</text> </paragraph> <paragraph num="(d)"> <text>Intensive individual support services reimbursed at the maximum rate of $21.49 per unit.</text> </paragraph> <paragraph num="(e)"> <text>Respite care reimbursed at the maximum rate of $16.80 per unit.</text> </paragraph> <paragraph num="(f)"> <text>Family consultation reimbursed at the maximum rates of $70.55 per unit.</text> </paragraph> <paragraph num="(g)"> <text>Adult life planning services reimbursed at the maximum rate of $70.55 per unit.</text> </paragraph> <paragraph num="(h)"> <text>Environmental accessibility adaptations reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the:</text> <paragraph num="(i)"> <text>Amount authorized by the State Department of Education; or</text> </paragraph> <paragraph num="(ii)"> <text>Actual cost of the job.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Effective July 1, 2023, the Program shall pay according to the following fee-for-service schedule:</text> <paragraph num="(a)"> <text>Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant:</text> <paragraph num="(i)"> <text>$283.69 per unit for the regular level of service; or</text> </paragraph> <paragraph num="(ii)"> <text>$567.45 per unit for the intensive level of service.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Therapeutic integration services reimbursed at the maximum rate of $8.5950 per unit.</text> </paragraph> <paragraph num="(c)"> <text>Intensive therapeutic integration services reimbursed at the maximum rate of $10.7450 per unit.</text> </paragraph> <paragraph num="(d)"> <text>Intensive individual support services reimbursed at the maximum rate of $10.7450 per unit.</text> </paragraph> <paragraph num="(e)"> <text>Respite care reimbursed at the maximum rate of $8.4000 per unit.</text> </paragraph> <paragraph num="(f)"> <text>Family consultation reimbursed at the maximum rate of $35.2750 per unit.</text> </paragraph> <paragraph num="(g)"> <text>Adult life planning services reimbursed at the maximum rate of $35.2750 per unit.</text> </paragraph> <paragraph num="(h)"> <text>Environmental accessibility adaptions reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the:</text> <paragraph num="(i)"> <text>Amount authorized by the State Department of Education; or</text> </paragraph> <paragraph num="(ii)"> <text>Actual cost of the job.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are set forth in COMAR 10.09.36.07 and include, but are not limited to:</text> <paragraph num="A."> <text>Providing waiver services without a valid required license or appropriate credentials as required;</text> </paragraph> <paragraph num="B."> <text>Employing staff or consultants that do not meet conditions for participation in accordance with Regulation .04 of this chapter to provide services to waiver participants;</text> </paragraph> <paragraph num="C."> <text>Lacking adequate documentation of services that were billed to the Program;</text> </paragraph> <paragraph num="D."> <text>Submitting claims for services not authorized in the participant's plan of care; and</text> </paragraph> <paragraph num="E."> <text>Providing services that are not in accordance with the requirements of this chapter and other applicable regulations and law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>In addition to the sanctions specified at COMAR 10.09.36.08, the Department may limit:</text> <paragraph num="(1)"> <text>The number of participants served by the provider; and</text> </paragraph> <paragraph num="(2)"> <text>The number and type of services provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Appeal Procedures for Providers."> <text>Appeal procedures for providers are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Appeal Procedures for Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".27" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-130, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2001 (28:12 Md. R. 1108)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F, G, H amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 repealed as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); repealed permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A, C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21E amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21F amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22D amended effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective April 16, 2012 (39:7 Md. R. 492); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); September 16, 2024 (51:18 Md. R.809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05Q amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E, M amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-1 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-1P amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-2 adopted effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G, H adopted effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14G amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-1 adopted effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-1B amended effective September 16, 2024 (51:18 Md. R.809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14-1C adopted effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15E adopted effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16C adopted effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16C amended effective September 16, 2024 (51:18 Md. R.809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16D adopted effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17E amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17F adopted effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B, C amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D adopted effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21E, H amended effective May 18, 2020 (47:10 Md. R. 516); September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21J adopted effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A, E amended effective November 27, 2023 (50:23 Md. R. 1004)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22D amended effective October 31, 2011 (38:22 Md. R. 1346); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22D, E amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22E amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> </annotations> </chapter> <chapter num="57" heading="Partially Capitated Programs Authority"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an entity which submits an application to become a partially capitated provider.</text> </paragraph> <paragraph num="(2)"> <text>“Capitation payment” means the sum of money paid by the Program on behalf of an enrollee on a regular periodic per capita basis for capitated services.</text> </paragraph> <paragraph num="(3)"> <text>“Capitated services” means a service provided by a PCP or one of its subcontractors for which the Department has agreed to pay a capitation payment to the PCP.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Enrollee” means a recipient who has entered into an agreement to receive certain Medical Assistance services from or through a PCP.</text> </paragraph> <paragraph num="(6)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(7)"> <text>“Partially capitated provider (PCP)” means a public or private legal entity which is organized for the purpose of providing or arranging for the provision of medical and health-related services which meets the conditions for participation in Regulations .02 and .03 of this chapter for enrollment and which is eligible to enter into a contract with the Department to receive a capitated payment for a limited number of services.</text> </paragraph> <paragraph num="(8)"> <text>“Program” means the Maryland Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(9)"> <text>“Provider” means a partially capitated provider.</text> </paragraph> <paragraph num="(10)"> <text>“Provider agreement” means the agreement between the Department and the partially capitated provider which specifies the terms of the relationship between the Department and the provider, and includes the amount of the capitation payment and the specific services to be provided for the capitation payment.</text> </paragraph> <paragraph num="(11)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for Qualification as a Partially Capitated Provider."> <paragraph num="A."> <text>An applicant shall demonstrate to the satisfaction of the Department that it has the managerial, financial, clinical, and administrative capability to carry out the duties required by these regulations.</text> </paragraph> <paragraph num="B."> <text>An applicant shall submit the following documents to the Department along with a completed application form:</text> <paragraph num="(1)"> <text>A narrative of the applicant's overall plan for providing and arranging for the provision of high quality services to enrollees efficiently, effectively, and economically;</text> </paragraph> <paragraph num="(2)"> <text>A description of the organization and staff responsible for delivering health care and a copy of the applicant's organizational documents;</text> </paragraph> <paragraph num="(3)"> <text>An annualized pro forma budget and financial plan for the operation of the organization or, at the Department's option, of the appropriate unit within the organization responsible for the operation for delivery of services pursuant to this regulation for the first 3 years of its anticipated operations which demonstrates its financial viability based on reasonable assumptions;</text> </paragraph> <paragraph num="(4)"> <text>An annualized cash flow chart;</text> </paragraph> <paragraph num="(5)"> <text>A statement of policy and procedures for accounting, methods of reimbursing subcontractors, and payment of emergency and out-of-area claims;</text> </paragraph> <paragraph num="(6)"> <text>Balance sheets;</text> </paragraph> <paragraph num="(7)"> <text>Any other financial information the Program requires;</text> </paragraph> <paragraph num="(8)"> <text>Full and complete information at all times as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the applicant has a 5 percent or more ownership interest;</text> </paragraph> <paragraph num="(9)"> <text>A detailed description of the applicant's quality assurance plan which demonstrates compliance with Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>A description of a system for the receipt and prompt adjudication of complaints and grievances by enrollees which complies with Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(11)"> <text>A description of the process by which data about services provided will be collected;</text> </paragraph> <paragraph num="(12)"> <text>Copies of all of the applicant's contracts with subcontractors;</text> </paragraph> <paragraph num="(13)"> <text>A description of the boundaries of the geographic area or area the applicant wishes to serve; and</text> </paragraph> <paragraph num="(14)"> <text>A copy of the applicant's marketing plan.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the applicant will be at risk for services it will not directly provide, the applicant shall identify and document a source of funds which will comprise the reserve account required by Regulation .10 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions of Participation."> <paragraph num="A."> <text>A PCP shall meet the general conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>In addition, the PCP shall:</text> <paragraph num="(1)"> <text>Ensure that all of its employees, subcontractors, and employees of its subcontractors are appropriately licensed in the jurisdiction in which they are practicing;</text> </paragraph> <paragraph num="(2)"> <text>Enter into and maintain contractual arrangements necessary to meet the medical and health needs of enrollees for which it is receiving a capitation payment, except for emergency treatment and out-of-area referrals;</text> </paragraph> <paragraph num="(3)"> <text>Accept all Medical Assistance recipients who qualify for the PCP's services who select the PCP and who reside in the PCP's designated geographic area;</text> </paragraph> <paragraph num="(4)"> <text>Allow each enrollee to choose his or her health professionals within the PCP to the extent possible and appropriate;</text> </paragraph> <paragraph num="(5)"> <text>Comply with the requirements of Regulations .05 — .12 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Monitor the quality of the services its subcontractors render to its enrollees;</text> </paragraph> <paragraph num="(7)"> <text>Be accessible 24 hours a day to enrollees unless the Program waives this requirement in the provider agreement;</text> </paragraph> <paragraph num="(8)"> <text>Agree to provide services to enrollees as promptly as appropriate;</text> </paragraph> <paragraph num="(9)"> <text>Have a marketing plan which has been approved by the Department and conduct marketing activities in accordance with that plan; and</text> </paragraph> <paragraph num="(10)"> <text>Meet all other applicable requirements of federal and State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In accordance with 42 CFR §434.26(b)(4), an applicant who does not come within one of the exceptions specified in 24 CFR §434.26(b) shall request from the Department a waiver of 42 CFR §434.26(a), which provides that Medicaid recipients and Medicare beneficiaries may constitute not more than 75 percent of the enrollees of a health maintenance organization or prepaid capitation plan. The Department shall pursue a waiver for good cause.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>Providers may be capitated for one of the following packages of services subject to the approval of the Department:</text> <paragraph num="A."> <text>Inpatient hospital services, as long as the applicant, if regulated by the Health Services Cost Review Commission, has received permission from that agency to receive capitation payments;</text> </paragraph> <paragraph num="B."> <text>Mental health services, including but not limited to, psychiatric inpatient treatment and community mental health outpatient services;</text> </paragraph> <paragraph num="C."> <text>Not more than two of the following services or groups of services:</text> <paragraph num="(1)"> <text>Outpatient hospital services,</text> </paragraph> <paragraph num="(2)"> <text>Physician services,</text> </paragraph> <paragraph num="(3)"> <text>Laboratory and X-ray services,</text> </paragraph> <paragraph num="(4)"> <text>Nursing facility services, EPSDT, and family planning services, and</text> </paragraph> <paragraph num="(5)"> <text>Home health services;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Any service covered by the Program other than a service specified in §A or C of this regulation;</text> </paragraph> <paragraph num="E."> <text>Inpatient hospital services as listed in §A of this regulation, plus one or more of the services included in §D of this regulation; or</text> </paragraph> <paragraph num="F."> <text>Not more than two of the services listed in §C of this regulation, plus one or more of the services included in §D of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Enrollment and Termination of Enrollment."> <paragraph num="A."> <text>The Department shall determine the boundaries of the geographic area that a PCP may serve. The Department shall limit enrollment in a PCP to recipients who live in that area.</text> </paragraph> <paragraph num="B."> <text>The PCP is responsible for the enrollment of recipients who have chosen to enroll in the PCP.</text> </paragraph> <paragraph num="C."> <text>The PCP shall enter into an enrollment contract with a recipient on the form approved by the Department.</text> </paragraph> <paragraph num="D."> <text>The PCP shall enroll eligible recipients in the order in which the eligible recipients apply and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures.</text> </paragraph> <paragraph num="E."> <text>Termination of enrollment may be initiated by the enrollee, the enrollee's parent, guardian, or legal representative, by the PCP, or by the Department.</text> </paragraph> <paragraph num="F."> <text>The Department shall approve all terminations of enrollment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Marketing."> <paragraph num="A."> <text>The PCP shall specify in its provider agreement the methods by which the PCP will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or recipients.</text> </paragraph> <paragraph num="B."> <text>The Department shall preapprove all marketing plans, procedures, and materials.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Quality Assurance."> <text>A PCP shall maintain an internal quality assurance system based on written policies, standards, and procedures that is in accordance with accepted medical practices and professional standards and that includes, at a minimum, the following:</text> <paragraph num="A."> <text>A comprehensive quality assurance plan which:</text> <paragraph num="(1)"> <text>Addresses both the quality of clinical care and nonclinical aspects of service such as accessibility, coordination, and continuity of care,</text> </paragraph> <paragraph num="(2)"> <text>Provides for review by physicians and other health professionals of the process followed in the provision of health services,</text> </paragraph> <paragraph num="(3)"> <text>Provides feedback to health professionals and PCP staff regarding performance and patient results,</text> </paragraph> <paragraph num="(4)"> <text>Objectively and systematically monitors and evaluates the quality and appropriateness of care to enrollees through quality of care studies and related activities, and</text> </paragraph> <paragraph num="(5)"> <text>Provides for continuous performance of the activities, including tracking of issues over time;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A comprehensive utilization management program monitored by the PCP's governing body; and</text> </paragraph> <paragraph num="C."> <text>A credentialing process for determining whether physicians and other health professionals who are under contract to the PCP are licensed and qualified to perform their services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Record Keeping and Reports."> <paragraph num="A."> <text>The PCP shall have an effective procedure for reporting to the Department the following information:</text> <paragraph num="(1)"> <text>The cost of operations;</text> </paragraph> <paragraph num="(2)"> <text>Patterns of utilization;</text> </paragraph> <paragraph num="(3)"> <text>The health status of enrollees;</text> </paragraph> <paragraph num="(4)"> <text>Information demonstrating that the PCP has a fiscally sound operation; and</text> </paragraph> <paragraph num="(5)"> <text>Complaints and grievances made by enrollees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The PCP shall collect and submit to the Department service specific encounter data by service type in the format and at the frequency designated by the Department.</text> </paragraph> <paragraph num="C."> <text>The PCP shall maintain adequate records to document that the services were delivered.</text> </paragraph> <paragraph num="D."> <text>The PCP shall prepare and submit to the Department quarterly financial and quality assurance reports as specified by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Confidentiality."> <text>Subject to the requirements of 42 CFR 431F (1994), the PCP and its subcontractors may not release or disclose any information concerning an enrollee except with the written permission of the:</text> <paragraph num="A."> <text>Department;</text> </paragraph> <paragraph num="B."> <text>Enrollee; or</text> </paragraph> <paragraph num="C."> <text>Enrollee's attorney, legal representative, or guardian.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Financial Solvency."> <paragraph num="A."> <text>The PCP shall include in its provider agreement a clause that the PCP will hold harmless both the Department and its enrollees from any liability for payment for the legal obligations of the PCP.</text> </paragraph> <paragraph num="B."> <text>The PCP shall give the Department access to the PCP's financial records at reasonable intervals in order to monitor the PCP's financial solvency.</text> </paragraph> <paragraph num="C."> <text>The PCP shall file annual audited financial statements with the Department. A PCP in operation for less than 1 year shall file an interim statement.</text> </paragraph> <paragraph num="D."> <text>The provider agreement shall provide for the continuation of benefits to all enrollees for the duration of the contract period for which payment has been made.</text> </paragraph> <paragraph num="E."> <text>The PCP shall have a financially sound operation as demonstrated by:</text> <paragraph num="(1)"> <text>A positive net worth; and</text> </paragraph> <paragraph num="(2)"> <text>Sufficient cash and adequate liquidity, as determined by the Department, to meet the PCP's obligations as they become due.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The PCP shall provide full and complete information as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the PCP has a 5 percent or more ownership interest.</text> </paragraph> <paragraph num="G."> <text>PCPs that are at risk for services that the PCPs do not directly provide shall deposit an amount equal to the portion of 2 months' capitation payments relating to the services in a reserve account in trust. The agreement establishing the reserve account, which is subject to the Department's approval, may provide that the Department is the sole beneficiary of the trust, and that the trust funds may be disbursed only at the request of the Department to prevent or postpone the PCP's insolvency.</text> </paragraph> <paragraph num="H."> <text>Minimum Insurance Coverage.</text> <paragraph num="(1)"> <text>The PCP shall provide written evidence to the Department on an annual basis that it has sufficient insurance issued by an insurer authorized by the Maryland Insurance Administrator to engage in the insurance business to protect its financial viability and its ability to carry out its contractual obligations.</text> </paragraph> <paragraph num="(2)"> <text>The coverage shall include at a minimum:</text> <paragraph num="(a)"> <text>Malpractice coverage for all professional and related employees of the provider as well as for the organization itself;</text> </paragraph> <paragraph num="(b)"> <text>Bonding of all employees and officers who have any responsibility for the accounting and financial management activities of the provider; and</text> </paragraph> <paragraph num="(c)"> <text>Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>PCPs which are governmental units or are funded by the Behavioral Health Administration or the Developmental Disabilities Administration of the Department and subject to the oversight of one of these agencies are exempt from the requirements of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Subcontracts."> <paragraph num="A."> <text>The PCP shall ensure that the following provisions are contained in all subcontracts:</text> <paragraph num="(1)"> <text>A description of the services to be provided by the subcontractor;</text> </paragraph> <paragraph num="(2)"> <text>A description of other activities to be performed by the subcontractor;</text> </paragraph> <paragraph num="(3)"> <text>Providing for release to the PCP of any information necessary for the PCP to perform any of its obligations under its contract with the Department, including but not limited to compliance with the reporting and quality assurance requirements of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>That the facilities and records of the subcontractor shall be open to inspection by the PCP and the Department and that medical records or copies of medical records will be transferred to the PCP upon request upon termination of the subcontractor;</text> </paragraph> <paragraph num="(5)"> <text>That a termination of the subcontract may not be effective without 30 days prior written notice to the Department;</text> </paragraph> <paragraph num="(6)"> <text>That the subcontractor shall look solely to the PCP for compensation for services provided to recipients;</text> </paragraph> <paragraph num="(7)"> <text>The subcontractor shall cooperate with the PCP in implementing the PCP's quality assurance program; and</text> </paragraph> <paragraph num="(8)"> <text>Such other provisions as the Department may reasonably require, taking into consideration the nature of the services to be provided and the requirements of this contract.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall preapprove subcontracts.</text> </paragraph> <paragraph num="C."> <text>A subcontract may not alter or negate the PCP's legal responsibility to the Department under the PCP's provider agreement and this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Internal Grievance Procedure."> <paragraph num="A."> <text>The PCP shall have an internal grievance procedure which has been preapproved by the Department. The PCP shall provide a copy of its internal grievance procedures to all enrollees.</text> </paragraph> <paragraph num="B."> <text>The internal grievance procedure may:</text> <paragraph num="(1)"> <text>Provide for the prompt resolution of any complaints of enrollees or their representatives;</text> </paragraph> <paragraph num="(2)"> <text>Assure the participation of individuals with the authority to require corrective action; and</text> </paragraph> <paragraph num="(3)"> <text>Require that a written record be made of all grievances and complaints by enrollees, and the responses taken by the PCP.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The PCP shall submit monthly reports to the Department that summarize any grievances and complaints, the actions taken by the PCP in response to the complaints and grievances, and the PCP's plans to address the problems raised in the complaints and grievances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Payment Procedure."> <paragraph num="A."> <text>The Department shall pay a PCP a per capita capitation payment for capitated services.</text> </paragraph> <paragraph num="B."> <text>The Department shall calculate the capitation payment as a percentage of the cost to the Program of providing the same services on a fee-for-service basis to an actuarially equivalent non-enrolled group.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Appeal Procedures."> <text>Appeal procedures under this chapter are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Interpretive Regulation."> <text>Interpretation of this regulation is subject to COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .17 adopted as an emergency provision effective June 14, 1995 (22:14 Md. R. 1051); adopted permanently effective October 23, 1995 (22:21 Md. R. 1616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10I amended effective March 30, 2026 (53:6 Md. R. 291)</annotation> </annotations> </chapter> <chapter num="58" heading="Family Planning Program"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter governs the coverage of services for the Medical Assistance Family Planning Program.</text> </paragraph> <paragraph num="B."> <text>Eligibility shall be established according to COMAR 10.09.37.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced practice nurse” means an individual who meets the requirements in COMAR 10.09.01.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(3)"> <text>“Early and Periodic Screening, Diagnostic and Treatment (EPSDT)” means the provision to individuals younger than 21 years old, of preventative health care under 42CFR §441.50 et seq. as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services.</text> </paragraph> <paragraph num="(4)"> <text>“Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health.</text> </paragraph> <paragraph num="(5)"> <text>“Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home, and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services.</text> </paragraph> <paragraph num="(6)"> <text>“Hospital” means an institution that is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(7)"> <text>“Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department and its subgrantees.</text> </paragraph> <paragraph num="(8)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(9)"> <text>“Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease.</text> </paragraph> <paragraph num="(10)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(11)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Participant” means an individual who is certified as eligible for the Family Planning Program as described in COMAR 10.09.37.</text> </paragraph> <paragraph num="(13)"> <text>“Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or similar establishment or institution which is legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located.</text> </paragraph> <paragraph num="(14)"> <text>“Physician” means an individual licensed to practice medicine in the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(15)"> <text>“Physician assistant” means an individual who meets the requirements in COMAR 10.09.55.</text> </paragraph> <paragraph num="(16)"> <text>“Physician office and other point-of-care laboratory” means a medical laboratory at a site or facility operated as a part of, or in association with, the medical practice of licensed medical practitioners permitted to perform clinical laboratory procedures, community health center, emergency treatment center, health maintenance organization, or county or local health department, where clinical laboratory procedures are performed for patients seen by the practitioner or a practitioner employed or otherwise engaged by one of these entities.</text> </paragraph> <paragraph num="(17)"> <text>“Program” means the Maryland Medical Assistance, Family Planning Program.</text> </paragraph> <paragraph num="(18)"> <text>“Provider” means a health care provider who:</text> <paragraph num="(a)"> <text>Meets the licensure requirements set forth in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Meets the conditions for participation set forth in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Provides the services described in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Requirements."> <paragraph num="A."> <text>An advanced practice nurse shall be licensed to practice as described in COMAR 10.09.01.</text> </paragraph> <paragraph num="B."> <text>A doctor of medicine or osteopath shall be licensed and legally authorized to practice medicine in the state in which the service is delivered as described in COMAR 10.09.02.</text> </paragraph> <paragraph num="C."> <text>A physician assistant must be licensed to practice as described in COMAR 10.09.55.</text> </paragraph> <paragraph num="D."> <text>Medical laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located:</text> <paragraph num="(1)"> <text>In Maryland or out-of-State with representation or specimen pick-up in Maryland, comply with the requirements of Health-General Article, §§17-202, 17-212, and 17-214.1, Annotated Code of Maryland, and COMAR 10.10.01; or</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State without representation or specimen pick-up in Maryland, comply with other applicable standards established by the state and locality in which the services are provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A pharmacy may not qualify as a provider without first having obtained a permit from the:</text> <paragraph num="(1)"> <text>Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Appropriate agency in the state in which the pharmacy is located.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Physician office and other point-of-care laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located:</text> <paragraph num="(1)"> <text>In Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State, comply with other applicable standards established by the state and locality in which the services are provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions of Participation."> <paragraph num="A."> <text>Providers shall be enrolled as Medical Assistance Program providers and shall meet the requirements for participation in the Maryland Medical Assistance Program as set forth in COMAR 10.09.36.03, as well as the requirements for participation as set forth in the COMAR chapter defining the provider and covered service being rendered.</text> </paragraph> <paragraph num="B."> <text>Services covered in Regulation .05A—C of this chapter shall be provided by:</text> <paragraph num="(1)"> <text>A physician;</text> </paragraph> <paragraph num="(2)"> <text>An advance practice nurse; or</text> </paragraph> <paragraph num="(3)"> <text>A physician assistant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Providers shall accommodate the cultural and ethnic diversity of the populations to be served.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <text>The following services are covered under this chapter:</text> <paragraph num="A."> <text>Office medical visits for the primary purpose of providing age and sex appropriate family planning services, which include:</text> <paragraph num="(1)"> <text>Focused history, physical exam, and laboratory testing necessary to evaluate and manage the participant’s choice of chemical, mechanical, or other method to prevent conception;</text> </paragraph> <paragraph num="(2)"> <text>Basic education regarding human sexuality and reproduction;</text> </paragraph> <paragraph num="(3)"> <text>Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each, and untoward effects and potential complications of each method; and</text> </paragraph> <paragraph num="(4)"> <text>Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specimen collection by venipuncture or capillary puncture when performed by either the medical practitioner or the laboratory;</text> </paragraph> <paragraph num="C."> <text>Pregnancy test if indicated by physical examination or history, or both, when performed by either the medical practitioner or the laboratory;</text> </paragraph> <paragraph num="D."> <text>The following laboratory tests:</text> <paragraph num="(1)"> <text>Hemoglobin or hematocrit, or both;</text> </paragraph> <paragraph num="(2)"> <text>Urinalysis for albumin sugar;</text> </paragraph> <paragraph num="(3)"> <text>Urine culture and sensitivity studies;</text> </paragraph> <paragraph num="(4)"> <text>Appropriate laboratory tests to screen for sexually transmitted infections;</text> </paragraph> <paragraph num="(5)"> <text>Smear wet mount and KOH with interpretation;</text> </paragraph> <paragraph num="(6)"> <text>Rubella titer of females without documentation of prior rubella immunization; and</text> </paragraph> <paragraph num="(7)"> <text>Pap smear;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Pharmaceutical supplies and devices:</text> <paragraph num="(1)"> <text>To prevent conception through chemical, mechanical, or other methods, which are covered by the Maryland Medical Assistance Program under COMAR 10.09.03.04; and</text> </paragraph> <paragraph num="(2)"> <text>To treat sexually transmitted infections when diagnosed during the course of an office visit, as outlined in §A of this regulation, which are covered under COMAR 10.09.03.04 except treatment for:</text> <paragraph num="(a)"> <text>Human immunodeficiency virus; and</text> </paragraph> <paragraph num="(b)"> <text>Hepatitis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Permanent sterilization only when performed according to criteria in 42 CFR Part 441, Subpart F, Sterilizations, as amended, and when the appropriate forms are:</text> <paragraph num="(1)"> <text>Properly completed; and</text> </paragraph> <paragraph num="(2)"> <text>Available in the medical record for review;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Human papillomavirus vaccine; and</text> </paragraph> <paragraph num="H."> <text>Abortions performed in accordance with Health-General Article, §15-103, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <paragraph num="A."> <text>The following services are not covered:</text> <paragraph num="(1)"> <text>Services not medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Transportation services;</text> </paragraph> <paragraph num="(3)"> <text>EPSDT services;</text> </paragraph> <paragraph num="(4)"> <text>Services delivered in an in-patient hospital setting or ambulatory surgical center other than:</text> <paragraph num="(a)"> <text>Permanent sterilizations; and</text> </paragraph> <paragraph num="(b)"> <text>A hysterosalpingogram following the Essure procedure;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Infertility services, including reversal of sterilization; and</text> </paragraph> <paragraph num="(6)"> <text>Any service not listed in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limitations for advanced practice nurse services covered under this chapter are those set forth in COMAR 10.09.01.05.</text> </paragraph> <paragraph num="C."> <text>Limitations for physician services covered under this chapter are those set forth in COMAR 10.09.02.05.</text> </paragraph> <paragraph num="D."> <text>Limitations for free-standing clinic services covered under this chapter are those set forth in COMAR 10.09.08.07.</text> </paragraph> <paragraph num="E."> <text>Limitations for pharmacy services covered under this chapter are those set forth in COMAR 10.09.03.05.</text> </paragraph> <paragraph num="F."> <text>Limitations for medical laboratory services covered under this chapter are those set forth in COMAR 10.09.09.05.</text> </paragraph> <paragraph num="G."> <text>Limitations for acute hospital services covered under this chapter are those set forth in COMAR 10.09.92.05.</text> </paragraph> <paragraph num="H."> <text>Limitations for physician assistant services covered under this chapter are those set forth in COMAR 10.09.55.05.</text> </paragraph> <paragraph num="I."> <text>Limitations for ambulatory surgery centers covered under this chapter are those set forth in COMAR 10.09.42.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures are those set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations are those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payment procedures for advanced practice nurses are those set forth in COMAR 10.09.01.06.</text> </paragraph> <paragraph num="D."> <text>Payment procedures for physician services in the office or home are those set forth in COMAR 10.09.02.07.</text> </paragraph> <paragraph num="E."> <text>Payment procedures for clinic services delivered in federally qualified health centers are those set forth in COMAR 10.09.08.05.</text> </paragraph> <paragraph num="F."> <text>Payment procedures for clinic services delivered in local health departments, family planning clinics, and other free-standing clinics are those set forth in COMAR 10.09.02.07.</text> </paragraph> <paragraph num="G."> <text>Payment procedures for pharmacy services are those set forth in COMAR 10.09.03.07.</text> </paragraph> <paragraph num="H."> <text>Payment procedures for medical laboratory services are those set forth in COMAR 10.09.09.07.</text> </paragraph> <paragraph num="I."> <text>Payment procedures for acute hospital services are those set forth in COMAR 10.09.92.07.</text> </paragraph> <paragraph num="J."> <text>Payment procedures for physician assistant services are those set forth in COMAR 10.09.55.06.</text> </paragraph> <paragraph num="K."> <text>Payment procedures for ambulatory surgery centers are those set forth in COMAR 10.09.42.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>The requirements related to appeal procedures under COMAR 10.09.36 and 10.09.37 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Fraud and Abuse."> <text>The requirements relating to fraud and abuse under COMAR 10.09.24.14 shall apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective October 19, 1994 (21:23 Md. R. 1930); adopted permanently effective April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B, C amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B, C amended effective January 12, 2009 (36:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, D, E amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective January 12, 2009 (36:1 Md. R. 21); March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended effective March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H adopted effective March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507); March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 11, 2012 (39:11 Md. R. 686); December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed and new Regulation .10 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686)</annotation> </annotations> </chapter> <chapter num="59" heading="Specialty Mental Health Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative services organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System.</text> </paragraph> <paragraph num="(2)"> <text>“Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department.</text> </paragraph> <paragraph num="(3)"> <text>“Definitive drug test” means a drug screening test that includes:</text> <paragraph num="(a)"> <text>The ability to identify individual drugs and distinguish between structural isomers, but not necessarily stereoisomers, using gas chromatography or mass spectrometry and liquid chromatography or mass spectrometry;</text> </paragraph> <paragraph num="(b)"> <text>Qualitative or quantitative results;</text> </paragraph> <paragraph num="(c)"> <text>All source types for specimen selection; and</text> </paragraph> <paragraph num="(d)"> <text>Specimen validity testing, per day, 1—22 or more drug classes including metabolites, if performed.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(5)"> <text>“Hospital” means an institution which:</text> <paragraph num="(a)"> <text>Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Individualized education program (IEP)” has the meaning stated in COMAR 10.09.50.01.</text> </paragraph> <paragraph num="(7)"> <text>“Individualized Family Service Plan (IFSP)” has the meaning stated in COMAR 10.09.50.01.</text> </paragraph> <paragraph num="(8)"> <text>“Local school system (LSS)” means a local public school district.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(10)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(11)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, medical assistance benefits.</text> </paragraph> <paragraph num="(13)"> <text>“Presumptive drug test” means a drug screening test that includes:</text> <paragraph num="(a)"> <text>Any number of drug classes;</text> </paragraph> <paragraph num="(b)"> <text>Any number of devices;</text> </paragraph> <paragraph num="(c)"> <text>The use of direct optical observation, instrument assisted direct optical observation or instrumented chemistry analyzers; and</text> </paragraph> <paragraph num="(d)"> <text>Sample validation.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(15)"> <text>“Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number.</text> </paragraph> <paragraph num="(16)"> <text>“Public Behavioral Health System” means the system that provides medically necessary behavioral health services, including mental health and substance use disorder services, for Medical Assistance participants and certain other uninsured individuals.</text> </paragraph> <paragraph num="(17)"> <text>“Specialty mental health services” means services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="General Conditions for Provider Participation."> <text>To participate in the Program, a provider shall:</text> <paragraph num="A."> <text>Meet the conditions for provider participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03;</text> </paragraph> <paragraph num="B."> <text>Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06;</text> </paragraph> <paragraph num="C."> <text>Have clearly defined and written patient care policies; and</text> </paragraph> <paragraph num="D."> <text>Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements:</text> <paragraph num="(1)"> <text>Includes the date of service with service start and end times;</text> </paragraph> <paragraph num="(2)"> <text>Includes the participant’s primary behavioral health complaint or reason for the visit;</text> </paragraph> <paragraph num="(3)"> <text>Includes a brief description of the service provided, including progress notes;</text> </paragraph> <paragraph num="(4)"> <text>Includes an official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate title;</text> </paragraph> <paragraph num="(5)"> <text>Is made available to the following as requested:</text> <paragraph num="(a)"> <text>The Department;</text> </paragraph> <paragraph num="(b)"> <text>The ASO;</text> </paragraph> <paragraph num="(c)"> <text>The Core Service Agency;</text> </paragraph> <paragraph num="(d)"> <text>The Office of Inspector General; and</text> </paragraph> <paragraph num="(e)"> <text>The Office of the Attorney General Medicaid Fraud Control Unit; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is consistent with the medical records confidentiality and disclosure requirements of:</text> <paragraph num="(a)"> <text>Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Relevant federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Provider Requirements for Participation."> <paragraph num="A."> <text>Individual Practitioner Providers. To participate in the Program as an individual practitioner of specialty mental health services, the provider shall:</text> <paragraph num="(1)"> <text>Be licensed and legally authorized to practice independently by the appropriate Board to practice in the state in which the service is rendered; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate, by training and experience, the competency to provide mental health services as one of the following:</text> <paragraph num="(a)"> <text>A licensed certified social worker-clinical;</text> </paragraph> <paragraph num="(b)"> <text>A nurse psychotherapist (APRN-PMH);</text> </paragraph> <paragraph num="(c)"> <text>A pediatric nurse practitioner with a PMHS;</text> </paragraph> <paragraph num="(d)"> <text>A nurse practitioner-psychiatric (CRNP-PMH);</text> </paragraph> <paragraph num="(e)"> <text>A physician who demonstrates the competency to provide specialty mental health services;</text> </paragraph> <paragraph num="(f)"> <text>A licensed certified counselor which includes:</text> <paragraph num="(i)"> <text>A licensed clinical professional counselor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed clinical marriage and family therapist;</text> </paragraph> <paragraph num="(iii)"> <text>A licensed clinical counselor-alcohol and drug; or</text> </paragraph> <paragraph num="(iv)"> <text>A licensed clinical professional art therapist;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A psychiatrist certified by the American Board of Psychiatry and Neurology or possessing the minimum educational and training requirements to take the Board of Psychiatry and Neurology examination for certification in psychiatry; or</text> </paragraph> <paragraph num="(h)"> <text>A psychologist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Community Mental Health Program Providers. To participate in the Program as a community-based mental health program provider, the provider shall be approved under COMAR 10.63.01, 10.63.02, and 10.63.06 and possess licensure by the Behavioral Health Administration as:</text> <paragraph num="(1)"> <text>A psychiatric rehabilitation program serving adults in compliance with COMAR 10.63.03.09;</text> </paragraph> <paragraph num="(2)"> <text>A psychiatric rehabilitation program serving minors in compliance with COMAR 10.63.03.10;</text> </paragraph> <paragraph num="(3)"> <text>A mobile treatment program, which shall:</text> <paragraph num="(a)"> <text>Comply with COMAR 10.63.03.04;</text> </paragraph> <paragraph num="(b)"> <text>Consist of a multidisciplinary team including, at a minimum:</text> <paragraph num="(i)"> <text>A program director that is a mental health professional;</text> </paragraph> <paragraph num="(ii)"> <text>A psychiatrist or psychiatric nurse practitioner (CRNP-PMH);</text> </paragraph> <paragraph num="(iii)"> <text>A licensed registered nurse;</text> </paragraph> <paragraph num="(iv)"> <text>At least one licensed social worker or licensed graduate social worker; and;</text> </paragraph> <paragraph num="(v)"> <text>At least one mental health professional who may include the staff identified in §B(3)(b)(iii) and (iv) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain sufficient staffing to fulfill the following service requirements including:</text> <paragraph num="(i)"> <text>Initial and continuing psychiatric evaluation, diagnosis, and individual treatment planning;</text> </paragraph> <paragraph num="(ii)"> <text>Medication services;</text> </paragraph> <paragraph num="(iii)"> <text>Independent living skills assessment and training;</text> </paragraph> <paragraph num="(iv)"> <text>Health promotion and training;</text> </paragraph> <paragraph num="(v)"> <text>Interactive therapies;</text> </paragraph> <paragraph num="(vi)"> <text>Crisis intervention services; and</text> </paragraph> <paragraph num="(vii)"> <text>Support, linkage, and advocacy; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>An outpatient mental health clinic in compliance with:</text> <paragraph num="(a)"> <text>COMAR 10.63.03.05; and</text> </paragraph> <paragraph num="(b)"> <text>Staffing requirements as described in COMAR 10.63.03.05 and including:</text> <paragraph num="(i)"> <text>A program director who is a licensed mental health professional or has a master’s degree in a related field and is employed by the OMHC and is on-site at the organization for at least 20 hours per week;</text> </paragraph> <paragraph num="(ii)"> <text>A medical director as described in COMAR 10.63.03.05 and is serving the organization for at least 20 hours per week;</text> </paragraph> <paragraph num="(iii)"> <text>A multidisciplinary licensed mental health professional staff as described in COMAR 10.63.03.05, including representatives of two different mental health professions, each of whom shall be on-site 50 percent of the OMHC’s regularly scheduled hours;</text> </paragraph> <paragraph num="(iv)"> <text>Graduate level students and interns, who may deliver services under supervision of a licensed mental health professional and when a licensed mental health professional co-signs all documentation of contact with participants.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Federally Qualified Health Centers. To participate in the Program as a Federally Qualified Health Center, the provider shall be in compliance with COMAR 10.09.08.</text> </paragraph> <paragraph num="D."> <text>Other Licensed or Approved Mental Health Providers. To participate in the Program as a specialty mental health provider not defined in §§A—C of this regulation, a provider shall be approved pursuant to COMAR as a:</text> <paragraph num="(1)"> <text>Targeted case management provider in compliance with:</text> <paragraph num="(a)"> <text>If serving children, COMAR 10.09.90; and</text> </paragraph> <paragraph num="(b)"> <text>If serving adults, COMAR 10.09.45;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Residential treatment center in compliance with COMAR 10.07.04 and 10.09.29;</text> </paragraph> <paragraph num="(3)"> <text>Hospital in compliance with COMAR 10.09.92—10.09.95;</text> </paragraph> <paragraph num="(4)"> <text>Non-hospital-based mental health psychiatric day treatment provider in compliance with:</text> <paragraph num="(a)"> <text>COMAR 10.63.03.08;</text> </paragraph> <paragraph num="(b)"> <text>Staffing requirements described in 10.63.03.08 and including:</text> <paragraph num="(i)"> <text>A multidisciplinary team employed at least on a part-time basis; and</text> </paragraph> <paragraph num="(ii)"> <text>A program director;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Service requirements as described in 10.63.03.08 and including:</text> <paragraph num="(i)"> <text>An individual treatment plan developed by the multi-disciplinary team within 4 working days of admission;</text> </paragraph> <paragraph num="(ii)"> <text>Psychopharmacological treatment;</text> </paragraph> <paragraph num="(iii)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(iv)"> <text>Activity therapy; and</text> </paragraph> <paragraph num="(v)"> <text>Other necessary medical, psychological, and social services; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>COMAR 10.05.01.11 for requirements of the physical environment;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>1915(i) Intensive Behavioral Health Services for Children, Youth, and Families Waiver provider in compliance with COMAR 10.09.89;</text> </paragraph> <paragraph num="(6)"> <text>Therapeutic behavioral service provider in compliance with COMAR 10.09.34;</text> </paragraph> <paragraph num="(7)"> <text>Medical laboratory in compliance with COMAR 10.09.09; or</text> </paragraph> <paragraph num="(8)"> <text>Local school systems in compliance with COMAR 10.09.50 as a provider of school-based health-related services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility."> <paragraph num="A."> <text>A participant is eligible for specialty mental health services if:</text> <paragraph num="(1)"> <text>The individual meets the Department’s medical necessity criteria; and</text> </paragraph> <paragraph num="(2)"> <text>The service is appropriate to the specific provider type or community-based mental health provider listed in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individuals are eligible for Psychiatric Rehabilitation Programs for adults if the individual:</text> <paragraph num="(1)"> <text>Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who:</text> <paragraph num="(a)"> <text>Is enrolled as a provider in the Program with an active status on the date of service;</text> </paragraph> <paragraph num="(b)"> <text>Facilitates an informed choice of psychiatric rehabilitation program providers; and</text> </paragraph> <paragraph num="(c)"> <text>Currently provides inpatient, residential treatment center, or outpatient mental health services to the individual;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has a diagnosis listed in COMAR 10.67.08.02N; and</text> </paragraph> <paragraph num="(3)"> <text>Is in need of program services in order to improve or restore independent living and social skills necessary to support the individual’s recovery, ability to make informed decisions and choices, and participation in community life.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Individuals are eligible for Psychiatric Rehabilitation Programs for minors if the individual:</text> <paragraph num="(1)"> <text>Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who:</text> <paragraph num="(a)"> <text>Is enrolled as a provider in the Program with an active status on the date of service;</text> </paragraph> <paragraph num="(b)"> <text>Facilitates an informed choice of psychiatric rehabilitation program providers; and</text> </paragraph> <paragraph num="(c)"> <text>Currently provides inpatient, residential treatment center, or outpatient mental health services to the minor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is currently in, and remains in, active mental health treatment;</text> </paragraph> <paragraph num="(3)"> <text>Has the appropriate consent to participate in psychiatric rehabilitation program services;</text> </paragraph> <paragraph num="(4)"> <text>Has a diagnosis listed in COMAR 10.67.08.02N and severe functional impairments in at least one life domain;</text> </paragraph> <paragraph num="(5)"> <text>With psychiatric rehabilitation program services, is expected to have reduced symptoms of their mental illness or functional behavioral impairment as a result of their mental illness based on the clinical evaluation and ongoing treatment plan; and</text> </paragraph> <paragraph num="(6)"> <text>Is at risk of requiring a higher level of care, or is returning from a higher level of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Individuals are eligible for Mobile Treatment Services if it is assessed that the individual will benefit from mobile treatment services and the individual is:</text> <paragraph num="(1)"> <text>Experiencing homelessness;</text> </paragraph> <paragraph num="(2)"> <text>Unable or unwilling to use, on a continuing basis, community-based mental health services that are prescribed for the individual; or</text> </paragraph> <paragraph num="(3)"> <text>In an institution or inpatient facility and would be able to reside in a community setting if the individual received MTS and other appropriate support services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>The ASO shall reimburse the following specialty mental health services rendered to participants when authorized by the ASO:</text> <paragraph num="(1)"> <text>Medically necessary specialty mental health services delivered by providers listed in Regulation .04 of this chapter, for which the primary diagnosis is listed in COMAR 10.67.08.02M or N;</text> </paragraph> <paragraph num="(2)"> <text>Telehealth services as defined in COMAR 10.09.49 when rendered in accordance with limitations in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Presumptive drug tests and definitive drug tests, when ordered by a specialty mental health provider, with a behavioral health primary diagnosis listed in COMAR 10.67.08.02M or N on the claim.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specialty mental health services billed by local school systems are covered under the following conditions:</text> <paragraph num="(1)"> <text>The services are not furnished as part of an individualized education program or individualized family service plan) as defined in COMAR 10.09.50.01; and</text> </paragraph> <paragraph num="(2)"> <text>The services are rendered by a school psychologist or school social worker that meets the qualifications described in COMAR 10.09.50.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not delivered in compliance with the COMAR references listed in Regulations .04 and .05 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational or experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>Specialty mental health services for participants in an institution for mental disease as defined in 42 CFR §435.1009 unless the service is delivered through the §1115 HealthChoice Demonstration Waiver;</text> </paragraph> <paragraph num="E."> <text>Specialty mental health visits solely for the purpose of:</text> <paragraph num="(1)"> <text>Prescribing medication;</text> </paragraph> <paragraph num="(2)"> <text>Administering medication;</text> </paragraph> <paragraph num="(3)"> <text>Drug or supply pick-up;</text> </paragraph> <paragraph num="(4)"> <text>Collecting laboratory specimens;</text> </paragraph> <paragraph num="(5)"> <text>Interpreting laboratory tests or panels; or</text> </paragraph> <paragraph num="(6)"> <text>Administering injections, unless the following are documented in the participant’s medical record:</text> <paragraph num="(a)"> <text>Medical necessity; and</text> </paragraph> <paragraph num="(b)"> <text>The participant’s inability to take appropriate oral medications;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program;</text> </paragraph> <paragraph num="G."> <text>Vocational counseling, vocational training at a classroom or job site, and academic or remedial educational services;</text> </paragraph> <paragraph num="H."> <text>Services provided to or for the primary benefit of individuals other than the participant;</text> </paragraph> <paragraph num="I."> <text>Outpatient Mental Health Clinic services delivered to a participant with a primary diagnosis of substance use disorder, unless the claim reflects a secondary diagnosis of mental health;</text> </paragraph> <paragraph num="J."> <text>An on-site psychiatric rehabilitation program visit by a participant on the same day that the participant receives medical day care services under COMAR 10.09.07;</text> </paragraph> <paragraph num="K."> <text>Psychiatric rehabilitation program services rendered via telehealth when:</text> <paragraph num="(1)"> <text>They are rendered as a group service; or</text> </paragraph> <paragraph num="(2)"> <text>The total services rendered via telehealth comprise more than 50 percent of a participant’s services rendered;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Non-emergency services not authorized by the ASO;</text> </paragraph> <paragraph num="M."> <text>Mental health services delivered by a primary care provider and reimbursed through Medicaid Fee for Service or the Maryland Medicaid Managed Care Program;</text> </paragraph> <paragraph num="N."> <text>Services delivered by Federally Qualified Health Centers other than those billed using the T-code or H-code, which may include the following, delivered by two separate but appropriately licensed providers:</text> <paragraph num="(1)"> <text>One T-code for mental health services per day; and</text> </paragraph> <paragraph num="(2)"> <text>One H-code for substance use disorder services per day;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Supported employment services provided by a community-based psychiatric rehabilitation program, except in cases of clinic coordination;</text> </paragraph> <paragraph num="P."> <text>Residential crisis services;</text> </paragraph> <paragraph num="Q."> <text>Respite care services, other than those provided through the 1915(i) Intensive Behavioral Health Services program described in COMAR 10.09.89;</text> </paragraph> <paragraph num="R."> <text>Services provided to participants in a hospital inpatient setting, with the exception of services delivered by:</text> <paragraph num="(1)"> <text>Physicians; and</text> </paragraph> <paragraph num="(2)"> <text>Nurse Practitioners;</text> </paragraph> </paragraph> <paragraph num="S."> <text>Housing services;</text> </paragraph> <paragraph num="T."> <text>Services rendered but not appropriately documented;</text> </paragraph> <paragraph num="U."> <text>Services reimbursed by the ASO not included in this chapter;</text> </paragraph> <paragraph num="V."> <text>Mobile Treatment or ACT Services without a minimum of four in-person services provided per month;</text> </paragraph> <paragraph num="W."> <text>Services rendered by community based specialty mental health programs with an immediate family member of an employee of the program serving on the governing body, board of directors, or advisory committee, whichever applies; and</text> </paragraph> <paragraph num="X."> <text>Psychiatric rehabilitation services referred by:</text> <paragraph num="(1)"> <text>An individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>An entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Authorization Requirements."> <paragraph num="A."> <text>The ASO shall establish a process, through a utilization review system, for authorization of specialty mental health services.</text> </paragraph> <paragraph num="B."> <text>The ASO shall authorize services that are:</text> <paragraph num="(1)"> <text>Medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Of a type, frequency, and duration that are consistent with expected results and cost-effective; and</text> </paragraph> <paragraph num="(3)"> <text>Delivered in a manner consistent with this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Preauthorization is not required before a provider renders services in an emergency department.</text> </paragraph> <paragraph num="D."> <text>Except as provided in Regulation .08C of this chapter, no payment shall be rendered for services that have not been authorized.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>Payment procedures shall be followed as specified in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>A provider shall deliver and document services in accordance with Department regulations in order to receive reimbursement.</text> </paragraph> <paragraph num="C."> <text>Unless the care is free to other patients, a provider shall bill the Program its usual and customary charge to the general public.</text> </paragraph> <paragraph num="D."> <text>The Department shall authorize supplemental payment on Medicare claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall make payment on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and</text> </paragraph> <paragraph num="(2)"> <text>The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telehealth, unless the services are provided in compliance with COMAR 10.09.49; or</text> </paragraph> <paragraph num="(4)"> <text>Services not authorized consistent with Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="H."> <text>The Department shall reimburse providers according to the fee schedule in COMAR 10.21.25.</text> </paragraph> <paragraph num="I."> <text>Psychiatric rehabilitation programs shall identify the mental health professional who referred the individual to psychiatric rehabilitation services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeal Procedures for Providers."> <text>Appeal procedures for providers are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Appeal Rights — Denial of Services."> <text>Appeal procedures for applicants and participants are as set forth in COMAR 10.01.03 and 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-105(b), 15-102.8, 15-103, 15-105, and 15-105.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective February 3, 1995 (22:4 Md. R. 232); adopted permanently effective June 5, 1995 (22:11 Md. R. 821)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .03—.07 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1291); emergency status expired December 31, 1997; amended permanently effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 12, 1996 (23:3 Md. R. 168)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 12, 1996 (23:3 Md. R. 168); August 10, 1998 (25:16 Md. R. 1274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07K—M amended effective August 10, 1998 (25:16 Md. R. 1274)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 under, Rehabilitation and Other Mental Health Services, repealed and new Regulations .01—.14 under, Specialty Mental Health Services, adopted effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1300); October 10, 2016 (43:20 Md. R. 1110); May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420); December 31, 2018 (45:26 Md. R. 1243); May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, D amended effective October 10, 2016 (43:20 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300); May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective October 10, 2016 (43:20 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, K, N amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07V amended effective December 31, 2018 (45:26 Md. R. 1243)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09F amended effective May 12, 2025 (52:9 Md. R. 405)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09I adopted effective April 23, 2018 (45:8 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective October 26, 2015 (42:21 Md. R. 1300)</annotation> </annotations> </chapter> <chapter num="60" heading="Senior Prescription Drug Assistance Program"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrator” means the third party that contracts with the Department to administer the Program.</text> </paragraph> <paragraph num="(2)"> <text>“Annual household income” has the meaning stated in Regulation .02B of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Eligible individual” means an individual who meets the criteria set forth in Regulation .02A of this chapter:</text> </paragraph> <paragraph num="(5)"> <text>“Enrollee” means an individual enrolled in the Senior Prescription Drug Assistance Program.</text> </paragraph> <paragraph num="(6)"> <text>“Household member” means:</text> <paragraph num="(a)"> <text>An eligible individual;</text> </paragraph> <paragraph num="(b)"> <text>The spouse of an eligible individual if the spouse resides in the same residence as the eligible individual; and</text> </paragraph> <paragraph num="(c)"> <text>An individual who:</text> <paragraph num="(i)"> <text>Is related to an eligible individual by blood, marriage, or adoption;</text> </paragraph> <paragraph num="(ii)"> <text>Resides in the same residence as the eligible individual; and</text> </paragraph> <paragraph num="(iii)"> <text>Is dependent on the eligible individual or the spouse of the eligible individual for at least one-half of the individual's support.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Prescription drug plan sponsor” means a nongovernmental entity that is certified by the Centers for Medicare and Medicaid Services as meeting the requirements of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 for offering in the State:</text> <paragraph num="(a)"> <text>A Medicare Part D prescription drug plan; or</text> </paragraph> <paragraph num="(b)"> <text>A Medicare Advantage Plan that provides prescription drug benefits.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Program” means the Senior Prescription Drug Assistance Program established under Health-General Article, Title 15, Subtitle 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Program Fund” means the Fund established under Insurance Article, §15-1004, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Reasonable administrative expenses” means administrative expenses including, but not limited to, marketing, advertising, mailing, printing, and fully allocated costs for administration of the Program.</text> </paragraph> <paragraph num="(11)"> <text>Support and Maintenance Furnished in-Kind.</text> <paragraph num="(a)"> <text>“Support and maintenance furnished in-kind” means any food or shelter that is:</text> <paragraph num="(i)"> <text>Given to an eligible individual or the spouse of an eligible individual without cost; or</text> </paragraph> <paragraph num="(ii)"> <text>Received by an eligible individual or the spouse of an eligible individual because another person has paid the cost.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Support and maintenance in-kind” includes the provision of room, rent, garbage collection services, mortgage payments, real property tax payments, and heating fuel, gas, electricity, water, and sewage payments.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility, Enrollment, and Disenrollment."> <paragraph num="A."> <text>To be eligible for enrollment in the Program, an individual shall:</text> <paragraph num="(1)"> <text>Be a resident of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be a Medicare beneficiary enrolled in the Medicare Part D Voluntary Prescription Drug Benefit Program or a Medicare Advantage Plan that provides Part D coverage;</text> </paragraph> <paragraph num="(3)"> <text>Have an annual household income, as described in §B of this regulation, at or below 300 percent of the Federal Poverty Guidelines that apply to the individual based on the number of household members of the individual;</text> </paragraph> <paragraph num="(4)"> <text>Not be enrolled in a health benefit plan, other than a Medicare Part D prescription drug plan or a Medicare Advantage Plan, that provides prescription drug benefits at the time the individual applies for enrollment in the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Not be eligible for a full federal low-income subsidy under 42 CFR §423.772.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Consideration of Annual Household Income.</text> <paragraph num="(1)"> <text>Annual household income to be considered in determining financial eligibility is both earned and unearned income of the applicant and spouse who reside in the same residence, projected for a 12-month period beginning with the month in which the person submits the application for enrollment in the Program.</text> </paragraph> <paragraph num="(2)"> <text>Earned income includes:</text> <paragraph num="(a)"> <text>Wages, commissions, fees, profit from self-employment, salaries, and tips;</text> </paragraph> <paragraph num="(b)"> <text>The value of nonmonetary compensation received for services rendered; and</text> </paragraph> <paragraph num="(c)"> <text>Profit from rent received from a roomer, tenant, or boarder.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Unearned income includes:</text> <paragraph num="(a)"> <text>Payment from unemployment insurance, the Family Investment Program, the Supplemental Security Income Program, Veteran's and Workers' Compensations, private insurance, Black Lung Program, Railroad Retirement, Social Security, pensions, annuities, and other regular benefits received;</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §B(4) of this regulation, support from absent relatives, support from legally responsible relatives, and income which is received on a regular basis from relatives and friends who are not legally responsible;</text> </paragraph> <paragraph num="(c)"> <text>Parental income received by a child as support from his natural or adoptive parents or putative father; and</text> </paragraph> <paragraph num="(d)"> <text>Income from assets received as either interest, dividends, or other income from savings accounts, certificates, stocks, bonds, insurance policies, mortgages, and from real property that is not included as earned income.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Unearned income does not include support and maintenance furnished in-kind.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An eligible individual may apply for enrollment in the Program by submitting a completed application to the Administrator.</text> </paragraph> <paragraph num="D."> <text>Maximum Capacity of Program.</text> <paragraph num="(1)"> <text>The Administrator may not enroll additional individuals at a time when the Program's total enrollment reaches the level authorized by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall maintain a waiting list of individuals who meet the eligibility requirements for the Program but who are not served by the Program because of funding limitations.</text> </paragraph> <paragraph num="(3)"> <text>If, after the Program reaches its maximum capacity as established by the Department, the number of individuals enrolled decreases, the Administrator may recommence enrolling eligible individuals in the Program as specified in this regulation, until the Program's enrollment again reaches the authorized maximum.</text> </paragraph> <paragraph num="(4)"> <text>The Department may direct the Administrator to limit enrollment based on the amount of money remaining in the Program Fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disenrollment.</text> <paragraph num="(1)"> <text>The Administrator may, after first providing reasonable notice to the enrollee, disenroll from the Program an enrollee for any of the causes specified in §E(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An enrollee may be disenrolled from the Program if the enrollee:</text> <paragraph num="(a)"> <text>Ceases to meet the eligibility criteria set forth in §A of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled in:</text> <paragraph num="(i)"> <text>A Medicare Part D prescription drug plan that does not charge a premium; or</text> </paragraph> <paragraph num="(ii)"> <text>A Medicare Advantage Plan that does not charge a premium for prescription drug coverage.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Outreach Program."> <paragraph num="A."> <text>The Department shall develop and implement an outreach program targeted at eligible individuals.</text> </paragraph> <paragraph num="B."> <text>The Department shall publicize the existence and eligibility requirements of the Program through the following entities:</text> <paragraph num="(1)"> <text>The Department of Aging;</text> </paragraph> <paragraph num="(2)"> <text>Local health departments;</text> </paragraph> <paragraph num="(3)"> <text>Continuing care retirement communities;</text> </paragraph> <paragraph num="(4)"> <text>Places of worship;</text> </paragraph> <paragraph num="(5)"> <text>Civic organizations;</text> </paragraph> <paragraph num="(6)"> <text>Community pharmacies; and</text> </paragraph> <paragraph num="(7)"> <text>Any other entity that the Department determines is appropriate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department of Aging, through its Senior Health Insurance Program, shall:</text> <paragraph num="(1)"> <text>Assist eligible individuals in applying for coverage under the Program; and</text> </paragraph> <paragraph num="(2)"> <text>Provide notice of the Program and its eligibility requirements to potentially eligible individuals who seek health insurance counseling services through the Department of Aging.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall ensure that the entities used to publicize the existence of the Program under §B of this regulation, have sufficient Program applications and enrollment materials for distribution.</text> </paragraph> <paragraph num="E."> <text>Mail-In Application.</text> <paragraph num="(1)"> <text>The Department shall develop a mail-in application for the Program.</text> </paragraph> <paragraph num="(2)"> <text>The Administrator shall make available mail-in applications to eligible individuals.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Any outreach performed by the Department on behalf of the Program shall be funded through the Program Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Administrator."> <paragraph num="A."> <text>Administrator Contract. The Administrator and the Department shall execute an Administrator contract specifying the terms under which the Administrator shall operate the Program, including but not limited to an agreement by the Administrator to:</text> <paragraph num="(1)"> <text>Provide the prescription drug benefit subsidies described in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Submit a detailed quarterly financial accounting of the Program, including the identification of all revenue and cost items to the Department;</text> </paragraph> <paragraph num="(3)"> <text>Develop and implement a marketing plan designed to notify eligible individuals throughout the State of the existence and eligibility criteria for the Program; and</text> </paragraph> <paragraph num="(4)"> <text>Collect and submit to the Department, data regarding the costs for program enrollees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Program Operation. The Administrator shall operate the Program in a manner consistent with:</text> <paragraph num="(1)"> <text>The terms of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The Administrator contract governing operation of the Program that is executed between the Department and the Administrator; and</text> </paragraph> <paragraph num="(3)"> <text>All applicable federal and State law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prescription Drug Benefit Subsidies. The Administrator shall pay to prescription drug plan sponsors the subsidy payments that the Program has agreed to make on behalf of member enrollees of the prescription drug plan sponsors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Program Description Booklet."> <paragraph num="A."> <text>The Administrator shall develop a Program description booklet.</text> </paragraph> <paragraph num="B."> <text>The Program description booklet is subject to approval by the Department.</text> </paragraph> <paragraph num="C."> <text>The Program description booklet shall describe the essential features of the Program including:</text> <paragraph num="(1)"> <text>Eligibility requirements;</text> </paragraph> <paragraph num="(2)"> <text>A listing of available prescription drug plans and details of the prescription drug plans;</text> </paragraph> <paragraph num="(3)"> <text>Termination provisions;</text> </paragraph> <paragraph num="(4)"> <text>Appeal procedures;</text> </paragraph> <paragraph num="(5)"> <text>Other Program guidelines; and</text> </paragraph> <paragraph num="(6)"> <text>All other terms, conditions, and limitations of the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prescription Drug Benefit Subsidy."> <paragraph num="A."> <text>The Program shall:</text> <paragraph num="(1)"> <text>Provide a prescription drug benefit subsidy, as determined by the Department, that may pay all or some of the deductibles, coinsurance payments, premiums, and copayments under the federal Medicare Part D Pharmaceutical Assistance Program for enrollees of the Program; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the subsidy to the maximum number of individuals eligible for enrollment in the Program, subject to the money available in the Program Fund.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program may annually provide an additional subsidy, up to the full amount of the Medicare Part D Prescription Drug Plan premium, for individuals who qualify for a partial federal low-income subsidy.</text> </paragraph> <paragraph num="C."> <text>The Department shall determine annually:</text> <paragraph num="(1)"> <text>The number of individuals to be enrolled in the Program;</text> </paragraph> <paragraph num="(2)"> <text>The amount of subsidy to be provided under §A of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of any additional subsidy provided under §B of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Contracts with Prescription Drug Plan Sponsors."> <paragraph num="A."> <text>The Department may enter into contracts with prescription drug plan sponsors who have been approved by the Centers for Medicare and Medicaid Services to offer Medicare Part D plans in the State.</text> </paragraph> <paragraph num="B."> <text>A prescription drug plan sponsor that enters into a contract with the Department shall agree to perform its obligations in a manner that complies with:</text> <paragraph num="(1)"> <text>Medicare Part D and any federal regulations adopted to implement Medicare Part D;</text> </paragraph> <paragraph num="(2)"> <text>The Program;</text> </paragraph> <paragraph num="(3)"> <text>The terms and conditions of the contract; and</text> </paragraph> <paragraph num="(4)"> <text>Guidance from the Centers for Medicare and Medicaid Services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A contract entered into with the Department shall include provisions that require the prescription drug plan sponsor to:</text> <paragraph num="(1)"> <text>Coordinate with the Program in identifying member enrollees;</text> </paragraph> <paragraph num="(2)"> <text>Accept the premium subsidy on behalf of member enrollees;</text> </paragraph> <paragraph num="(3)"> <text>Apply the premium subsidy to the member enrollee's total premium costs;</text> </paragraph> <paragraph num="(4)"> <text>Separately bill member enrollees for any premium owed in excess of the premium subsidy paid by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Account for the subsidies received from the Program;</text> </paragraph> <paragraph num="(6)"> <text>Communicate in writing with member enrollees, including notifying member enrollees of their enrollment status;</text> </paragraph> <paragraph num="(7)"> <text>Share enrollment data and information with the Department;</text> </paragraph> <paragraph num="(8)"> <text>Report data and enrollment information as required by the Department;</text> </paragraph> <paragraph num="(9)"> <text>Reconcile Program and member payments with enrollment data; and</text> </paragraph> <paragraph num="(10)"> <text>Transmit information to appropriate third-parties, including the Administrator and the Centers for Medicare and Medicaid Services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Program Fund."> <paragraph num="A."> <text>The Program Fund shall include:</text> <paragraph num="(1)"> <text>Interest and investment income attributable to the Program Fund; and</text> </paragraph> <paragraph num="(2)"> <text>Money deposited to the account by a nonprofit health service plan in accordance with §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On or before April 1, 2003 and quarterly thereafter, the nonprofit health service plan required to subsidize the Program under Insurance Article, §14-106(d), Annotated Code of Maryland, shall deposit to the Program Fund the amount that is necessary to operate and administer the Program for the following quarter.</text> </paragraph> <paragraph num="C."> <text>The amount deposited by the nonprofit health service plan under §C of this regulation:</text> <paragraph num="(1)"> <text>Shall be determined by the Department based on enrollment, expenditures, and revenue for the previous year; and</text> </paragraph> <paragraph num="(2)"> <text>May not exceed the amounts specified in Insurance Article, §14-106(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall provide funds to the Administrator, in accordance with the contract with the Administrator, for the cost of the State subsidy and administrative expenses incurred on behalf of the Program.</text> </paragraph> <paragraph num="E."> <text>The Administrator shall:</text> <paragraph num="(1)"> <text>Permit inspection of its papers, books, and records pertaining to its operation of the Program by the Department or its designee; and</text> </paragraph> <paragraph num="(2)"> <text>Cooperate with any inspections and audits performed on the Administrator or the Program by the Department or its designee.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-1005(b)(1), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from 31.17.04 Senior Prescription Drug Assistance Program, to 10.09.60 Senior Prescription Drug Program effective July 1, 2016</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 13, 2017 (44:3 Md. R. 188)</annotation> </annotations> </chapter> <chapter num="61" heading="Medical Day Care Services Waiver"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants.</text> </paragraph> <paragraph num="(2)"> <text>“Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, or other individual designated in writing to the Department, authorized concerning the applicant's or recipient's eligibility under this chapter, to:</text> <paragraph num="(a)"> <text>Act on an applicant's or recipient's behalf; and</text> </paragraph> <paragraph num="(b)"> <text>Assist with the application or redetermination process and in other communication with the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>"Centers for Medicare and Medicaid Services (CMS)" means the federal agency responsible for administering Medicare, Medicaid, and several other health related programs.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Eligibility” means an individual's qualification for participation in the Medical Day Care Services Waiver, in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Eligible” means that an individual is determined to meet the requirements of this chapter for eligibility as a Medical Day Care Services Waiver participant.</text> </paragraph> <paragraph num="(7)"> <text>“Medicaid” means the Maryland Medical Assistance Program administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients.</text> </paragraph> <paragraph num="(8)"> <text>“Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Day Care Services Waiver” means the program implemented under this chapter in accordance with the CMS-approved application for this waiver and any amendments to it submitted by the Department and approved by CMS.</text> </paragraph> <paragraph num="(10)"> <text>“Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, healthcare professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care.</text> </paragraph> <paragraph num="(11)"> <text>“Nursing facility” means a facility that is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10.</text> </paragraph> <paragraph num="(12)"> <text>“Participant” means an individual who:</text> <paragraph num="(a)"> <text>Meets the qualifications for participation in the waiver as specified in Regulations .02 through .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled by the Department to receive waiver services.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22 and based on:</text> <paragraph num="(a)"> <text>A medical order; and</text> </paragraph> <paragraph num="(b)"> <text>An assessment of the participant’s health status and special care requirements.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant.</text> </paragraph> <paragraph num="(15)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(16)"> <text>“Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department, and identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(17)"> <text>“Recipient” means a person who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(18)"> <text>“Service plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community.</text> </paragraph> <paragraph num="(19)"> <text>“State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements.</text> </paragraph> <paragraph num="(20)"> <text>“Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq.</text> </paragraph> <paragraph num="(21)"> <text>“Waiver” means the Medical Day Care Services Waiver as implemented through this chapter.</text> </paragraph> <paragraph num="(22)"> <text>“Waiver applicant” means an individual who is applying for participation in the waiver to receive the services covered under this chapter.</text> </paragraph> <paragraph num="(23)"> <text>“Waiver year” means the State fiscal year from July 1 through June 30.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Medical Assistance Eligibility."> <paragraph num="A."> <text>Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a:</text> <paragraph num="(1)"> <text>Recipient of Supplemental Security Income (SSI);</text> </paragraph> <paragraph num="(2)"> <text>Member of a low income family with children, as described in §1931 of the Social Security Act; or</text> </paragraph> <paragraph num="(3)"> <text>Recipient eligible in another mandatory or optional categorically needy coverage group covered in the community under the State Plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as an aged, blind, or disabled medically needy individual in accordance with COMAR 10.09.24.03D and .09.</text> </paragraph> <paragraph num="C."> <text>An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>Medical Eligibility.</text> <paragraph num="(1)"> <text>To be eligible for the services covered under COMAR 10.09.07, a waiver applicant or participant shall be certified by the Department or its designee as needing nursing facility services, pursuant to COMAR 10.09.10.</text> </paragraph> <paragraph num="(2)"> <text>The initial assessment for enrollment to the Program shall be conducted by AERS and submitted to the Department or its designee for certification.</text> </paragraph> <paragraph num="(3)"> <text>For the purpose of enrollment, the assessment of the applicant’s need for nursing facility services is valid for 1 year.</text> </paragraph> <paragraph num="(4)"> <text>The Department or its designee shall annually certify as medically eligible only those financially eligible participants who require nursing facility services as defined under COMAR 10.09.10.</text> </paragraph> <paragraph num="(5)"> <text>The annual continued stay assessment shall be conducted by the medical day care provider's nursing staff or, at the discretion of the Department, by the Department's designee, with an assessment instrument approved by the Department and submitted to the Department or its designee for certification.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technical Eligibility. An individual shall be determined by the Department or its designee to be eligible for waiver services if the individual:</text> <paragraph num="(1)"> <text>Is 16 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Is not enrolled simultaneously in both the Medical Day Care Services Waiver, and:</text> <paragraph num="(a)"> <text>Another Medicaid home and community-based services waiver under §1915(c) of the Social Security Act;</text> </paragraph> <paragraph num="(b)"> <text>Programs of All-Inclusive Care for the Elderly (PACE); or</text> </paragraph> <paragraph num="(c)"> <text>A Medicaid capitated program that includes nursing facility or community-based long term care services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Has a service plan that:</text> <paragraph num="(a)"> <text>Recommends medical day care services at least one time per week based on a medical order;</text> </paragraph> <paragraph num="(b)"> <text>Is based on an initial or continued stay assessment approved by the Department or its designee;</text> </paragraph> <paragraph num="(c)"> <text>Is developed and signed by:</text> <paragraph num="(i)"> <text>The participant or authorized representative; and</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate members of the multidisciplinary team;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Is revised as necessary due to a significant change in the participant’s condition or service needs;</text> </paragraph> <paragraph num="(e)"> <text>Is reviewed at least annually by the participant or authorized representative and the multidisciplinary team to:</text> <paragraph num="(i)"> <text>Determine the appropriateness and adequacy of the services; and</text> </paragraph> <paragraph num="(ii)"> <text>Ensure that the services furnished are consistent with the nature and severity of the participant's condition and with the plan of care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is determined by the Department or its designee as appropriate for home and community-based care;</text> </paragraph> <paragraph num="(5)"> <text>Is informed of feasible alternatives to nursing facility services that are available under the waiver;</text> </paragraph> <paragraph num="(6)"> <text>Is offered the choice between waiver and nursing facility services; and</text> </paragraph> <paragraph num="(7)"> <text>Chooses, or the individual's authorized representative chooses on the individual's behalf, to receive waiver services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Waiver Eligibility."> <paragraph num="A."> <text>Based on the criteria established in Regulations .02 and .03 of this chapter, an applicant's eligibility for services under this chapter shall be established by the Department, and waiver eligibility may not begin before the latest of the following five dates:</text> <paragraph num="(1)"> <text>Waiver application date;</text> </paragraph> <paragraph num="(2)"> <text>Effective date of medical certification for the waiver's institutional level of care;</text> </paragraph> <paragraph num="(3)"> <text>Date that the applicant's written waiver service plan is established;</text> </paragraph> <paragraph num="(4)"> <text>Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; or</text> </paragraph> <paragraph num="(5)"> <text>Date of the applicant's discharge from institutionalization in a long term care facility, if applicable.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department or its designee shall reevaluate a participant's eligibility for waiver services annually.</text> </paragraph> <paragraph num="C."> <text>A participant shall be terminated from participation in the waiver as of the effective date of ineligibility as determined by the Department if the participant:</text> <paragraph num="(1)"> <text>No longer meets the eligibility requirements specified in Regulations .02 and .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Voluntarily chooses, or the participant's authorized representative chooses on the participant's behalf, to disenroll from the waiver;</text> </paragraph> <paragraph num="(3)"> <text>Moves to another state;</text> </paragraph> <paragraph num="(4)"> <text>Is an inpatient for 30 consecutive days or more in a chronic hospital or nursing facility;</text> </paragraph> <paragraph num="(5)"> <text>Does not receive waiver services for 90 consecutive days; or</text> </paragraph> <paragraph num="(6)"> <text>Dies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reenrollment in the Waiver. If an individual is terminated from the waiver, the same individual may reenroll in the waiver during the same waiver year, if the individual meets all of the eligibility requirements of the waiver.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Annual Cap and Registry for Waiver Participation."> <paragraph num="A."> <text>For each State fiscal year beginning on July 1, the Department shall establish a cap, approved by CMS, for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding.</text> </paragraph> <paragraph num="B."> <text>The annual cap for waiver participation may be revised, based on the Department's updated estimates of participants' Program expenditures for the State fiscal year, as compared with the available funding.</text> </paragraph> <paragraph num="C."> <text>Eligible individuals shall be enrolled in the waiver program on a first-come, first-served basis until the annual cap on waiver participation is reached.</text> </paragraph> <paragraph num="D."> <text>Once the annual cap on waiver participation is reached:</text> <paragraph num="(1)"> <text>A registry shall be established for individuals interested in applying for waiver services; and</text> </paragraph> <paragraph num="(2)"> <text>Individuals on the registry shall have an opportunity to apply for the waiver as openings become available.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Conditions for Provider Participation."> <paragraph num="A."> <text>Conditions for provider participation are those set forth in COMAR 10.09.07.</text> </paragraph> <paragraph num="B."> <text>Providers shall maintain a service plan for each participant that includes:</text> <paragraph num="(1)"> <text>Name, address, and telephone number of the participant;</text> </paragraph> <paragraph num="(2)"> <text>Medical Assistance number of the participant;</text> </paragraph> <paragraph num="(3)"> <text>Name and telephone number of the participant’s primary care provider and of any managed care organization with which the participant is enrolled;</text> </paragraph> <paragraph num="(4)"> <text>Dated signatures of the participant or authorized representative, and each of the other individuals participating on the multidisciplinary team;</text> </paragraph> <paragraph num="(5)"> <text>A statement that the participant or authorized representative shall have access to the individual's medical day care services plan of care;</text> </paragraph> <paragraph num="(6)"> <text>A statement that enrollment is voluntary, but that the participant or the participant's caregiver shall notify the medical day care center when the participant is unable to attend;</text> </paragraph> <paragraph num="(7)"> <text>Authorization and frequency of attendance of medical day care services;</text> </paragraph> <paragraph num="(8)"> <text>Names of provider or providers that render waiver or State Plan services; and</text> </paragraph> <paragraph num="(9)"> <text>Approval by the Department or its designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Covered Services."> <text>Covered services are those set forth in COMAR 10.09.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Limitations."> <text>Limitations are those set forth in COMAR 10.09.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <text>Payment procedures are those set forth in COMAR 10.09.07.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures for Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Cause for suspension or removal and imposition of sanctions for providers shall be in accordance with COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>If the Department determines that a provider has failed to accurately assess the rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs of an applicant or consumer, and to accurately convey such an assessment to the Department for purposes of obtaining an authorization to provide medical day care services, the Department shall:</text> <paragraph num="(1)"> <text>Suspend all eligibility decisions based upon assessments submitted by the provider until such time as the provider's assessment is validated by an independent assessment conducted by the Department's utilization control agent or the Department's designee; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct remedial training of provider staff in accurately assessing rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs, and in accurately conveying such assessments to the Department or its designee for purposes of establishing medical eligibility for medical day care service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-111, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective October 6, 2008 (35:20 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 273); May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective May 20, 2019 (46:10 Md. R. 485)</annotation> </annotations> </chapter> <chapter num="62" heading="Separate Children’s Health Insurance Program (CHIP) and CHIP Health Services Initiative Eligibility"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter governs the determination of eligibility for the separate Children’s Health Insurance Program (separate CHIP) and the CHIP Health Services Initiative with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014.</text> </paragraph> <paragraph num="B."> <text>Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the birthing parent would qualify for Medicaid but for their immigration status, when the family income is equal to or less than 250 percent of the federal poverty level.</text> </paragraph> <paragraph num="C."> <text>Eligibility for the CHIP Health Services Initiative for the birthing parent of a targeted low-income child may be established beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends if the targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56).</text> </paragraph> <paragraph num="(2)"> <text>Applicant.</text> <paragraph num="(a)"> <text>“Applicant” means an individual whose written application for the separate CHIP Program has been submitted to the local health department or the local department of social services but has not received final action.</text> </paragraph> <paragraph num="(b)"> <text>“Applicant” includes an individual whose application is submitted through a representative.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an insurance affordability program to the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>“Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized representative” has the meaning stated in COMAR 10.01.04.12.</text> </paragraph> <paragraph num="(6)"> <text>“Birthing parent” means the individual who gives birth to the targeted low-income child who is enrolled in the separate CHIP Program on the day prior to their birth.</text> </paragraph> <paragraph num="(7)"> <text>“CHIP Health Services Initiative” means services offered to improve the health of low-income children pursuant to §2105(a)(1)(D)(ii) of the Social Security Act.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Determination” means a decision regarding an applicant’s eligibility for the separate CHIP Program.</text> </paragraph> <paragraph num="(10)"> <text>“Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and participants.</text> </paragraph> <paragraph num="(11)"> <text>“Family members” means those individuals living with the applicant whose income is counted as household income under Regulation .07B of this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981.</text> </paragraph> <paragraph num="(13)"> <text>“Inpatient services” means services received by a participant while in a medical institution, birthing center, or clinic for which Medical Assistance is provided.</text> </paragraph> <paragraph num="(14)"> <text>“Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04.</text> </paragraph> <paragraph num="(15)"> <text>“Insurance affordability program” means a program that is one of the following:</text> <paragraph num="(a)"> <text>Maryland Medicaid;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium;</text> </paragraph> <paragraph num="(c)"> <text>The separate CHIP Program;</text> </paragraph> <paragraph num="(d)"> <text>An optional state basic health program established under §1331 of the Affordable Care Act;</text> </paragraph> <paragraph num="(e)"> <text>A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under 26 U.S.C. §36B of the Internal Revenue Code; or</text> </paragraph> <paragraph num="(f)"> <text>A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under 42 U.S.C. §1402 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Living together” means sharing a common household.</text> </paragraph> <paragraph num="(17)"> <text>“MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act.</text> </paragraph> <paragraph num="(18)"> <text>“Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI-based insurance affordability programs, including, by delegation, certain eligibility in the program.</text> </paragraph> <paragraph num="(19)"> <text>“Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(20)"> <text>“Period under consideration” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(21)"> <text>“Postpartum period” means the period of time beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends.</text> </paragraph> <paragraph num="(22)"> <text>“Public institution” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(23)"> <text>“Qualified alien” has the meaning defined in 8 U.S.C. §1641.</text> </paragraph> <paragraph num="(24)"> <text>“Participant” means an individual who is certified as eligible for the Maryland Children’s Health Program.</text> </paragraph> <paragraph num="(25)"> <text>“Redetermination” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(26)"> <text>“Separate CHIP Program” means the program for targeted low-income children established under Title XXI of the Social Security Act.</text> </paragraph> <paragraph num="(27)"> <text>“Spouse” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(28)"> <text>“Targeted low-income child” means an individual who qualifies for the Maryland Children’s Health Program from conception to birth when the birthing parent is not eligible for Medicaid as a citizen or qualified alien, when the family income is equal to or less than 250 percent of the federal poverty level.</text> </paragraph> <paragraph num="(29)"> <text>“Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low-income individuals.</text> </paragraph> <paragraph num="(30)"> <text>“Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the separate CHIP Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Coverage Groups."> <paragraph num="A."> <text>Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the:</text> <paragraph num="(1)"> <text>Birthing parent is not a citizen or qualified alien; and</text> </paragraph> <paragraph num="(2)"> <text>Family income is equal to or less than 250 percent of the federal poverty level.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility for the CHIP Health Services Initiative may be established for a birthing parent for postpartum coverage if a targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application."> <paragraph num="A."> <text>The Department or its designee shall determine eligibility for a targeted low-income child and a birthing parent.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall give oral, written, or electronic information about the separate CHIP Program and CHIP Health Services Initiative such as:</text> <paragraph num="(1)"> <text>Requirements for eligibility;</text> </paragraph> <paragraph num="(2)"> <text>Available services;</text> </paragraph> <paragraph num="(3)"> <text>An individual’s rights and responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>Information in plain English, supported by translation services; and</text> </paragraph> <paragraph num="(5)"> <text>Information accessible to disabled individuals requesting an application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual requesting health coverage from an insurance affordability program shall be given an opportunity to apply.</text> </paragraph> <paragraph num="D."> <text>The Department or its designee shall make the application available to the individual without delay by telephone, by mail, in person, or by internet or other available electronic means, and in a manner accessible to disabled individuals requesting an application.</text> </paragraph> <paragraph num="E."> <text>A resident temporarily absent from the State but intending to return may apply for health coverage from an insurance affordability program by telephone, by mail, in person, or by internet or other available electronic means to the Department or its designee in any jurisdiction. The individual shall:</text> <paragraph num="(1)"> <text>Demonstrate continued residency in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all nonfinancial and financial requirements to be determined eligible.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Application Filing and Signature Requirements.</text> <paragraph num="(1)"> <text>An individual who wishes to apply for health coverage under an insurance affordability program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant’s choice.</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee.</text> </paragraph> <paragraph num="H."> <text>An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation.</text> </paragraph> <paragraph num="I."> <text>Period Under Consideration.</text> <paragraph num="(1)"> <text>The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>For a targeted low-income child, the period under consideration is from conception to birth, and for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for the separate CHIP Program if those months are prior to the birth.</text> </paragraph> <paragraph num="(3)"> <text>For the birthing parent, the period under consideration is the postpartum period and contingent on the application of the targeted low-income child on or before the last day of the fourth month after the pregnancy ends.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Processing applications time limitations shall operate in accordance with the requirements of COMAR 10.09.24.04.</text> </paragraph> <paragraph num="K."> <text>Required Information. All information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative shall be reported. When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application — Additional Requirements."> <paragraph num="A."> <text>Third-Party Liability.</text> <paragraph num="(1)"> <text>A participant shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the participant’s medical expenses.</text> </paragraph> <paragraph num="(2)"> <text>A participant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments.</text> </paragraph> <paragraph num="(3)"> <text>In accident situations, a participant shall notify the Department or its designee of the:</text> <paragraph num="(a)"> <text>Time, date, and location of the accident;</text> </paragraph> <paragraph num="(b)"> <text>Name and address of the participant’s attorney;</text> </paragraph> <paragraph num="(c)"> <text>Names and addresses of all parties and witnesses to the accident; and</text> </paragraph> <paragraph num="(d)"> <text>Police report number if an investigation is made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department or its designee shall:</text> <paragraph num="(1)"> <text>Maintain a written or electronic record including documentation of any required elements of eligibility; and</text> </paragraph> <paragraph num="(2)"> <text>Restrict disclosure of information concerning a participant to purposes directly connected with the administration of the Medical Assistance Program, including:</text> <paragraph num="(a)"> <text>Establishing eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Determining the extent of coverage under Medical Assistance;</text> </paragraph> <paragraph num="(c)"> <text>Providing services for participants; and</text> </paragraph> <paragraph num="(d)"> <text>Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant or participant shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nonfinancial Eligibility Requirements."> <paragraph num="A."> <text>Individuals qualifying for coverage under this section are not required to provide a Social Security number or meet satisfactory immigration status.</text> </paragraph> <paragraph num="B."> <text>Residency. To be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements of COMAR 10.09.24.05-3.</text> </paragraph> <paragraph num="C."> <text>Age. To be eligible for benefits under this chapter, a birthing parent shall apply for coverage before the last day of the fourth month after the pregnancy ends, regardless of the birthing parent’s age.</text> </paragraph> <paragraph num="D."> <text>Inmate of a Public Institution. To receive benefits under this chapter, a targeted low-income child or birthing parent may not be an inmate of a public institution, as specified in COMAR 10.09.24.05-5B.</text> </paragraph> <paragraph num="E."> <text>Institution for Mental Diseases. To be eligible for benefits under this chapter, a targeted low-income child or birthing parent may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C.</text> </paragraph> <paragraph num="F."> <text>No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, a targeted low-income child or birthing parent whose income is equal to 133 percent but less than 250 percent of the Federal Poverty Level may not be covered by an employer-sponsored health benefit plan.</text> </paragraph> <paragraph num="G."> <text>Required Information.</text> <paragraph num="(1)"> <text>An applicant shall report to the Department all information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative.</text> </paragraph> <paragraph num="(2)"> <text>When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Consideration of Household Income."> <paragraph num="A."> <text>The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent.</text> </paragraph> <paragraph num="B."> <text>Determining Countable Household Income.</text> <paragraph num="(1)"> <text>In determining an applicant’s financial eligibility for the separate CHIP Program, the applicant’s current household income is considered.</text> </paragraph> <paragraph num="(2)"> <text>For the targeted low-income child applicant, household income shall consist of the income of the child applicant and the following family members when living with the child applicant:</text> <paragraph num="(a)"> <text>The child applicant’s parents; and</text> </paragraph> <paragraph num="(b)"> <text>At the option of the child applicant’s parents, any of the child applicant’s siblings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application.</text> </paragraph> <paragraph num="D."> <text>Treatment of Income.</text> <paragraph num="(1)"> <text>Countable gross income for the separate CHIP Program shall be the household income calculated according to MAGI.</text> </paragraph> <paragraph num="(2)"> <text>MAGI income limits shall be:</text> <paragraph num="(a)"> <text>Converted from traditional income limits to account for elimination of income disregards; and</text> </paragraph> <paragraph num="(b)"> <text>Increased by 5 percentage points of the federal poverty level for the following circumstances:</text> <paragraph num="(i)"> <text>When an individual’s income exceeds the Medicaid income standard; and</text> </paragraph> <paragraph num="(ii)"> <text>The income standard is the highest income standard under which the individual can be determined eligible.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Household Composition. For purposes of determining the income standard applicable to an applicant or participant, the following rules apply:</text> <paragraph num="(a)"> <text>An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made;</text> </paragraph> <paragraph num="(b)"> <text>For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals:</text> <paragraph num="(i)"> <text>Spouse; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted, or step children;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals:</text> <paragraph num="(i)"> <text>Natural, adopted, or step parents; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted, or step siblings;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made; and</text> </paragraph> <paragraph num="(e)"> <text>For a child applicant, the household size shall consist of the child and the following individuals:</text> <paragraph num="(i)"> <text>Natural, adopted, or step parents; and</text> </paragraph> <paragraph num="(ii)"> <text>Natural, adopted, or step siblings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>No resources or assets test may be applied to an applicant or participant who is subject to a MAGI-based income test.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Determining Financial Eligibility."> <text>An applicant is financially eligible for the separate CHIP Program or the CHIP Health Services Initiative if, for the period under consideration, the applicant’s countable household income as determined under Regulation .07 of this chapter does not exceed 250 percent of the federal poverty level for a family size equal to the size of the family of the applicant.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Certification Periods."> <paragraph num="A."> <text>For a targeted low-income child, certification for the separate CHIP Program begins:</text> <paragraph num="(1)"> <text>On the first day of the month of application, no earlier than conception, and continues until the last day of the month in which the pregnancy ends; or</text> </paragraph> <paragraph num="(2)"> <text>For retroactive coverage, if medical expenses were incurred during the earlier months:</text> <paragraph num="(a)"> <text>3 months before the month of application but no earlier than conception; and</text> </paragraph> <paragraph num="(b)"> <text>Continues until the last day of the month in which the pregnancy ends.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For the birthing parent of a targeted low-income child, certification for the CHIP Health Services Initiative begins:</text> <paragraph num="(1)"> <text>On the first day of the month following the end of the pregnancy, and continues until the last day of the fourth month after the pregnancy ends;</text> </paragraph> <paragraph num="(2)"> <text>For retroactive coverage, if medical expenses were incurred during the earlier months:</text> <paragraph num="(a)"> <text>3 months before the month of application, if those months are not prior to the last day of the month in which the pregnancy ends; and</text> </paragraph> <paragraph num="(b)"> <text>Continues until the last day of the month in which the pregnancy ends.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Covered Services."> <paragraph num="A."> <text>A targeted low-income child certified for the separate CHIP Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program.</text> </paragraph> <paragraph num="B."> <text>A birthing parent certified for the CHIP Health Services Initiative is entitled to all health benefits through the Maryland Medicaid Managed Care Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Post-Eligibility Requirements."> <paragraph num="A."> <text>Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant’s legal rights and obligations and give the applicant written or electronic notification of the following:</text> <paragraph num="(1)"> <text>For eligible individuals:</text> <paragraph num="(a)"> <text>The basis and effective date for eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Instructions for reporting changes that may affect the participants’ eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For ineligible individuals:</text> <paragraph num="(a)"> <text>A finding of ineligibility, the reason for the finding, and the regulation supporting the finding;</text> </paragraph> <paragraph num="(b)"> <text>Information regarding application for MAGI Exempt coverage groups; and</text> </paragraph> <paragraph num="(c)"> <text>The right to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Participant Responsibility.</text> <paragraph num="(1)"> <text>After an individual has been determined to be eligible for the separate CHIP Program and is enrolled in the separate CHIP Program, the participant or the participant’s representative shall:</text> <paragraph num="(a)"> <text>Within 10 days of the occurrence, notify the Department if there is a change in the participant’s, the participant’s parent’s, or the participant’s guardian’s:</text> <paragraph num="(i)"> <text>Income;</text> </paragraph> <paragraph num="(ii)"> <text>Employment;</text> </paragraph> <paragraph num="(iii)"> <text>Address; or</text> </paragraph> <paragraph num="(iv)"> <text>Health insurance coverage status;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Limit use of the Medical Assistance card to the individual whose name appears on the card; and</text> </paragraph> <paragraph num="(c)"> <text>When written or electronic notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure to comply with §B(1) of this regulation may result in:</text> <paragraph num="(a)"> <text>The termination of assistance; or</text> </paragraph> <paragraph num="(b)"> <text>Referral to the Department for fraud investigation, or for criminal or civil prosecution.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A participant shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility.</text> </paragraph> <paragraph num="(4)"> <text>If the participant refuses to cooperate, the participant’s coverage shall be terminated subject to timely and adequate notice under COMAR 10.01.04.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unscheduled Redetermination.</text> <paragraph num="(1)"> <text>The Department or its designee shall:</text> <paragraph num="(a)"> <text>Promptly make an unscheduled redetermination of a child participant’s eligibility when changes in circumstances or relevant facts are:</text> <paragraph num="(i)"> <text>Reported by someone on the participant’s behalf; or</text> </paragraph> <paragraph num="(ii)"> <text>Brought to the attention of the Department or its designee from other responsible sources;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Notify the participant that redetermination is required to establish continuing eligibility; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the participant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Eligibility Decisions. Participants who are determined:</text> <paragraph num="(a)"> <text>Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A participant whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Scheduled Redetermination. Except for children eligible as newborns of eligible individuals the Department or its designee shall make a scheduled redetermination of a child participant’s eligibility at least every 12 months.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Hearings."> <text>The requirements relating to hearings under COMAR 10.01.04 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Fraud and Abuse."> <text>The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Adjustments and Recoveries."> <text>The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, except for COMAR 10.09.24.15A(1) and (2), apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation.</text> </regulation> <annotations> <annotation type="Authority">Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 13, 2023 (50:22 Md. R. 974)</annotation> </annotations> </chapter> <chapter num="63" heading="Community Violence Prevention Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certified violence prevention professional” means a prevention professional who meets the requirements of Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Community violence” means intentional acts of interpersonal violence committed in public areas by individuals who are not family members or intimate partners of the victim.</text> </paragraph> <paragraph num="(3)"> <text>“Community violence prevention services” means evidence-based, trauma-informed, supportive, and nonpsychotherapeutic services provided by a certified violence prevention professional, within or outside a clinical setting, for the purpose of promoting improved health outcomes and positive behavioral change, preventing injury recidivism, and reducing the likelihood that an individual who is the victim of community violence will commit or promote violence.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Interpersonal violence” means the intentional use of physical force or power against another individual by an individual or a small group of individuals.</text> </paragraph> <paragraph num="(6)"> <text>“Provider” means the entity who through appropriate agreement with the Department has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification Requirements."> <paragraph num="A."> <text>An individual rendering services under this chapter shall complete an accredited training and certification program for certified violence prevention professionals, approved by the Department.</text> </paragraph> <paragraph num="B."> <text>An accredited training and certification program for certified violence prevention professionals shall:</text> <paragraph num="(1)"> <text>Consist of at least 35 hours of initial training, addressing the following topics:</text> <paragraph num="(a)"> <text>The profound effects of trauma and violence and the basics of trauma-informed care;</text> </paragraph> <paragraph num="(b)"> <text>Community violence prevention strategies, including conflict mediation and retaliation prevention related to community violence;</text> </paragraph> <paragraph num="(c)"> <text>Case management and advocacy practices; and</text> </paragraph> <paragraph num="(d)"> <text>Patient privacy and the federal Health Insurance Portability and Accountability Act of 1996; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Require at least 6 hours of continuing education every 2 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(2)"> <text>If rendering services via telehealth, comply with COMAR 10.09.49 and any sub regulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a community violence prevention service provider are that a provider shall:</text> <paragraph num="(1)"> <text>Maintain documentation that an individual rendering community violence prevention services under this chapter meets the certification requirements as provided in Regulation .02 of this chapter and maintain documentation of certification;</text> </paragraph> <paragraph num="(2)"> <text>Maintain an affiliation with at least one trauma Primary Adult Resource Center (PARC), level I, or level II licensed short-term general hospital or children’s hospital in Maryland through which the provider entity is authorized to provide community violence prevention services to beneficiaries in the hospital; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the certified violence prevention professional is providing community violence prevention services in compliance with any applicable standard of care, rule, regulation, and State or federal law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>Effective July 1, 2023, the Department shall reimburse for community violence prevention services as described in §B of this regulation when these services:</text> <paragraph num="(1)"> <text>Are medically necessary; and</text> </paragraph> <paragraph num="(2)"> <text>Rendered to a participant who:</text> <paragraph num="(a)"> <text>Has been exposed to community violence or has a personal history of injury resulting from community violence;</text> </paragraph> <paragraph num="(b)"> <text>Is at an elevated risk of violent injury or retaliation resulting from another act of community violence, as determined by a certified or licensed health care provider or social services provider; and</text> </paragraph> <paragraph num="(c)"> <text>Has been referred by a certified or licensed health care provider to a certified violence prevention professional to receive community violence prevention services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Community violence prevention services shall include one or more of the following interventions:</text> <paragraph num="(1)"> <text>Mentorship;</text> </paragraph> <paragraph num="(2)"> <text>Conflict mediation;</text> </paragraph> <paragraph num="(3)"> <text>Crisis intervention;</text> </paragraph> <paragraph num="(4)"> <text>Referrals to certified or licensed health care professionals or social services providers;</text> </paragraph> <paragraph num="(5)"> <text>Patient education; and</text> </paragraph> <paragraph num="(6)"> <text>Screening services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall cover a maximum of 100 30-minute units of services in a rolling 12-month period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Under this chapter, the Program does not cover services:</text> <paragraph num="A."> <text>Following an episode of intimate partner violence or domestic violence;</text> </paragraph> <paragraph num="B."> <text>Delivered by a provider that is not affiliated with a trauma PARC, level I, or level II licensed short-term general hospital or children’s hospital in Maryland; and</text> </paragraph> <paragraph num="C."> <text>Provided in excess of 100 30-minute units of services in a rolling 12-month period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>The provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §G of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program will reimburse a provider for covered services:</text> <paragraph num="(1)"> <text>The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>In accordance with §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider may not bill the Program or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payments for services rendered to a Program participant shall be made directly to a qualified provider or program.</text> </paragraph> <paragraph num="F."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="G."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>Payments shall be made in 30-minute units of service.</text> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023, rates for the services outlined in this chapter shall be reimbursed at $32.76 per unit.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 13, 2023 (50:22 Md. R. 974)</annotation> </annotations> </chapter> <chapter num="64" heading="Collaborative Care Model"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Behavioral health care manager” means a nurse, clinical social worker, or psychologist working under the oversight and direction of the physician or other primary care provider with formal education or specialized training to provide coordination and intervention in behavioral health.</text> </paragraph> <paragraph num="(2)"> <text>“Collaborative Care Model” means the Psychiatric Collaborative Care Model, a patient-centered, evidence-based approach for integrating physical and behavioral health services in primary care settings that includes:</text> <paragraph num="(a)"> <text>Care coordination and management;</text> </paragraph> <paragraph num="(b)"> <text>Regular, systematic monitoring and treatment using a validated clinical rating scale;</text> </paragraph> <paragraph num="(c)"> <text>Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and</text> </paragraph> <paragraph num="(d)"> <text>Regular, systematic consultation for patients who do not show clinical improvement.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Federally qualified health center (FQHC)" means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act.</text> </paragraph> <paragraph num="(4)"> <text>“Participant” means an individual who:</text> <paragraph num="(a)"> <text>Has been determined to meet the qualifications for services under the Collaborative Care Model as specified in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled with the Department to receive Medicaid services.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Primary care provider (PCP)” means a physician, or other provider type as defined in COMAR 10.67.05.05, who is the primary coordinator of care for the enrollee, and whose responsibility is to provide accessible, continuous, comprehensive, and coordinated health services covering the full range of benefits required by the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(6)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(7)"> <text>“Psychiatric consultant” means a licensed psychiatrist, psychiatric nurse practitioner, addiction medicine specialist, or any other behavioral health medicine specialist as allowed under federal regulations governing the model who is trained in psychiatry and qualified to prescribe medication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>A provider may not knowingly employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Program participants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Services."> <text>The Program covers the following medically necessary services rendered to participants under the Collaborative Care Model:</text> <paragraph num="A."> <text>Care coordination and management;</text> </paragraph> <paragraph num="B."> <text>Regular, systematic monitoring and treatment using a validated clinical rating scale;</text> </paragraph> <paragraph num="C."> <text>Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and</text> </paragraph> <paragraph num="D."> <text>Regular, systematic consultation for patients who do not show clinical improvement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility for Services."> <text>Eligibility for services under the Collaborative Care Model is limited to participants with a behavioral health diagnosis that is clinically appropriate for the primary care setting for which there is a validated tool to monitor symptoms and quantify outcomes.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>Under this chapter, the Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Services prohibited by the Maryland Nurse Practice Act or by the State Board of Nursing;</text> </paragraph> <paragraph num="D."> <text>Advanced practice nursing services included as part of the cost of:</text> <paragraph num="(1)"> <text>An inpatient facility;</text> </paragraph> <paragraph num="(2)"> <text>A hospital outpatient department; or</text> </paragraph> <paragraph num="(3)"> <text>A freestanding clinic;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Visits by or to the provider solely for the purpose of the following:</text> <paragraph num="(1)"> <text>Prescription, drug, or food supplement pick-up;</text> </paragraph> <paragraph num="(2)"> <text>Recording of an electrocardiogram;</text> </paragraph> <paragraph num="(3)"> <text>Ascertaining the patient’s weight;</text> </paragraph> <paragraph num="(4)"> <text>Interpretation of laboratory tests or panels; or</text> </paragraph> <paragraph num="(5)"> <text>Prescribing or administering medication;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Drugs and supplies which are acquired by the provider at no cost;</text> </paragraph> <paragraph num="G."> <text>Services paid under the free-standing dialysis program as described in COMAR 10.09.22;</text> </paragraph> <paragraph num="H."> <text>Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control;</text> </paragraph> <paragraph num="I."> <text>Acupuncture;</text> </paragraph> <paragraph num="J."> <text>Hypnosis;</text> </paragraph> <paragraph num="K."> <text>Travel expenses;</text> </paragraph> <paragraph num="L."> <text>Investigational or experimental drugs and procedures;</text> </paragraph> <paragraph num="M."> <text>Services denied by Medicare as not medically justified;</text> </paragraph> <paragraph num="N."> <text>Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service;</text> </paragraph> <paragraph num="O."> <text>Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and</text> </paragraph> <paragraph num="P."> <text>For certified nurse midwives, a separate visit charge on date of delivery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment of services rendered according to procedures established by the Program and in the form designated by the Program.</text> </paragraph> <paragraph num="B."> <text>The Program reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Program.</text> </paragraph> <paragraph num="C."> <text>Unless the service is free to the general public, the provider shall charge the Program the provider’s customary charge to the general public for similar services.</text> </paragraph> <paragraph num="D."> <text>If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §G of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Program will pay for covered services, the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Program’s fee schedule.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The provider may not bill the Program or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail;</text> </paragraph> <paragraph num="(4)"> <text>Professional services rendered via telehealth when services are indicated as an exclusion; or</text> </paragraph> <paragraph num="(5)"> <text>Providing a copy of a participant’s medical record when requested by another provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>Providers may bill one 60-minute or 70-minute code per month, and two additional 30-minute codes per month, unless otherwise excepted in §G(2)or (3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>FQHCs may bill once per month, using a separate FQHC code.</text> </paragraph> <paragraph num="(3)"> <text>If the primary care team determines that the participant’s condition requires more or less frequent visits than described above, the care manager may order an alternate schedule.</text> </paragraph> <paragraph num="(4)"> <text>The Maryland Medical Assistance Program's procedures for payment are contained in COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Causes for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15–141.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 5, 2024 (51:15 Md. R. 707)</annotation> </annotations> </chapter> <chapter num="65" heading="Maryland Medicaid Managed Care Program: Managed Care Organizations" reason="Transferred to COMAR 10.67.04"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.23 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.23 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02C, .04C, .08, .11, .15, .17A, .18, .20B, and .22C amended and Regulation .11-1 adopted as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144); November 1, 1999 (26:22 Md. R. 1692); February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G and H amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03T adopted effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. 1838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 18, 2002 (29:3 Md. R.220); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 and .11-2 adopted February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 and .11-2E amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11-1 and .11-2 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 9, 1998 (25:3 Md. R. 144); December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D, E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective February 9, 1998 (25:3 Md. R. 144); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 amended effective December 25, 2000 (27:25 Md. R.2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1C adopted effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); emergency status extended at 26:1 Md. R. 17, 26:6 Md. R. 480, and 26:8 Md. R. 614; emergency status expired May 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective December 25, 2000 (27:25 Md. R.2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931 and 29:4 Md. R. 413</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1—.19-3 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1—.19-4 adopted effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1 and .19-2 repealed and new Regulation .19-1 adopted effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-1 repealed as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); repealed permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-3 and .19-4 amended and recodified to be new Regulations .19-2 and .19-3 effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-4 adopted effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-5 and.19-6 adopted as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931; emergency status extended at 29:4 Md. R. 413</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective December 25, 2000 (27:25 Md. R. 2281); December 24, 2001 (28:25 Md. R. 2190); July 7, 2003 (30:13 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; adopted permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A amended and F—J adopted effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulations .24 and .25 adopted as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective December 25, 2000 (27:25 Md. R.2281); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24-1 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G, J, X amended effective November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02O, S amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02V amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02Z adopted effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02CC amended effective October 5, 2009 (36:20 Md. R. 1528); March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02DD adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02EE adopted effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K, L amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02FF adopted effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 19, 2005 (32:25 Md. R. 1941); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787); February 6, 2012 (39:2 Md. R. 141); December 24, 2012 (39:25 Md. R. 1613); December 12, 2013 (40:24 Md. R. 2017); August 29, 2016 (43:17 Md. R. 955); November 7, 2016 (43:22 Md. R. 1221); December 31, 2018 (45:26 Md. R. 1245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 10, 2006 (33:7 Md. R. 668); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C, E amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08I amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08K amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08M repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11F amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-2 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15C amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15E amended effective December 19, 2005 (32:25 Md. R. 1941); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15F amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15L adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 repealed effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180); February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18H amended effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18I, J adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective April 1, 2005 (32:9 Md. R. 847); amended permanently effective July 18, 2005 (32:14 Md. R. 1276)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A, B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); amended permanently effective June 16, 2008 (35:12 Md. R. 1120)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective December 20, 2004 (31:25 Md. R.1790); December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 669)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective July 1, 2006 (33:20 Md. R. 1610); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective January 1, 2007 (34:4 Md. R. 396); amended permanently effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective September 14, 2007 (34:21 Md. R. 1911); amended permanently effective November 19, 2007 (34:23 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective January 12, 2009 (36:1 Md. R. 21); July 27, 2009 (36:15 Md. R. 1166); January 25, 2010 (37:2 Md. R. 67); June 14, 2010 (37:12 Md. R. 800); December 27, 2010 (37:26 Md. R. 1788); April 4, 2011 (37:8 Md. R. 431); April 30, 2012 (39:8 Md. R. 534); December 10, 2012 (39:24 Md. R. 1577); July 7, 2014 (41:13 Md. R. 752); February 16, 2015 (42:3 Md. R. 316); October 26, 2015 (42:21 Md. R. 1301); May 9, 2016 (43:9 Md. R. 530); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 446); amended permanently effective May 24, 2004 (31:10 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended effective June 14, 2010 (37:12 Md. R. 800); October 26, 2015 (42:21 Md. R. 1301); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended effective June 19, 2006 (33:12 Md. R. 997); April 9, 2007 (34:7 Md. R. 698); June 14, 2010 (37:12 Md. R. 800); April 30, 2012 (39:8 Md. R. 534)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 repealed effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3A, B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3A, B amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3B amended effective December 24, 2012 (39:25 Md. R. 1613); February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3C amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3C, D amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5 adopted effective December 19, 2005 (32:25 Md. R. 1941)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5 repealed and new Regulation .19-5 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5F amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5G amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5H amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective August 8, 2011 (38:16 Md. R. 945); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective April 10, 2006 (33:7 Md. R. 668); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, B amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, D amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B, C amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E adopted effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21B amended effective June 19, 2006 (33:12 Md. R. 997); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C, D amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23C amended effective November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23D amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23D amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 repealed effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.04 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="66" heading="Assistance in Community Integration Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assistance in Community Integration Services (ACIS)” means the ACIS program, a health related social needs benefit for qualified individuals, which is implemented in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(2)"> <text>“Compliance activities” means tasks undertaken to ensure that ACIS is delivered in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(3)"> <text>“Continuum of Care Program” means the regional or local planning body that coordinates housing and services funding for families and individuals experiencing homelessness.</text> </paragraph> <paragraph num="(4)"> <text>“Homelessness” has the meaning stated in 24 CFR §578.3.</text> </paragraph> <paragraph num="(5)"> <text>“Lead entity” means a local health department or local governmental agency, which:</text> <paragraph num="(a)"> <text>Has been awarded participant spaces in the ACIS program;</text> </paragraph> <paragraph num="(b)"> <text>Is an enrolled provider with the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(c)"> <text>Is responsible for leadership, coordination, oversight, and monitoring of ACIS;</text> </paragraph> <paragraph num="(d)"> <text>Shall serve as the organizing hub and contact point for ACIS with all collaborators, including the participant’s MCO; and</text> </paragraph> <paragraph num="(e)"> <text>Shall facilitate the financial arrangement and payments with designated subcontractors.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Participant” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(8)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>A lead entity shall:</text> <paragraph num="(1)"> <text>Have been awarded participant spaces for ACIS by the Program; and</text> </paragraph> <paragraph num="(2)"> <text>Be a member of its local Continuum of Care Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Eligibility for Services."> <text>Eligibility for ACIS services under this chapter is limited to individuals who meet the following health and housing criteria:</text> <paragraph num="A."> <text>The individual is a participant that uses Maryland Medical Assistance;</text> </paragraph> <paragraph num="B."> <text>The individual meets at least one of the following health criteria:</text> <paragraph num="(1)"> <text>Repeated emergency department visits;</text> </paragraph> <paragraph num="(2)"> <text>Repeated hospital admissions in the past year; or</text> </paragraph> <paragraph num="(3)"> <text>Two or more chronic conditions as defined in §1945(h)(2) of the Social Security Act; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>The individual meets at least one of the following housing criteria:</text> <paragraph num="(1)"> <text>Is homeless, chronically homeless, or at risk of homelessness as defined in 24 CFR §578.3; or</text> </paragraph> <paragraph num="(2)"> <text>Is at risk of institutional placement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program shall cover the following ACIS services:</text> <paragraph num="(1)"> <text>Compliance activities; and</text> </paragraph> <paragraph num="(2)"> <text>Housing and tenancy-based case management services when three or more services, as specified in §B of this regulation, are delivered per month per participant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Housing and tenancy-based case management services include the following:</text> <paragraph num="(1)"> <text>Community integration assessments to identify the participant’s:</text> <paragraph num="(a)"> <text>Housing preferences;</text> </paragraph> <paragraph num="(b)"> <text>Needs for support to maintain community integration;</text> </paragraph> <paragraph num="(c)"> <text>Budgeting needs;</text> </paragraph> <paragraph num="(d)"> <text>Needs for assistance applying for social services; and</text> </paragraph> <paragraph num="(e)"> <text>Needs for support regarding understanding and meeting obligations of tenancy;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The development of a person-centered community integration plan with enumerated measurable goals inclusive of review and modification of the plan when necessary;</text> </paragraph> <paragraph num="(3)"> <text>Participation in meetings related to:</text> <paragraph num="(a)"> <text>Housing support;</text> </paragraph> <paragraph num="(b)"> <text>Crisis management; and</text> </paragraph> <paragraph num="(c)"> <text>Person-centered planning;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Assistance in connecting individuals with social services defined in the integration plan such as:</text> <paragraph num="(a)"> <text>Housing required to meet the participant’s medical care needs;</text> </paragraph> <paragraph num="(b)"> <text>Independent living services;</text> </paragraph> <paragraph num="(c)"> <text>Counseling services;</text> </paragraph> <paragraph num="(d)"> <text>Employment support services;</text> </paragraph> <paragraph num="(e)"> <text>Services required to meet the participant’s medical needs;</text> </paragraph> <paragraph num="(f)"> <text>Transportation for services; and</text> </paragraph> <paragraph num="(g)"> <text>Entitlement programs;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Assistance in communication with property managers or landlord for accommodation needs; and</text> </paragraph> <paragraph num="(6)"> <text>Connecting the participant to training and resource support related to being housed and household management.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>Under this chapter, the Program does not cover the following:</text> <paragraph num="(1)"> <text>Services provided to or for the primary benefit of individuals other than the participant;</text> </paragraph> <paragraph num="(2)"> <text>Services rendered but not appropriately documented; and</text> </paragraph> <paragraph num="(3)"> <text>Room and board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Providers may not bill for monthly ACIS case-management services if less than three housing and tenancy-based case management services were rendered to the participant for the month.</text> </paragraph> <paragraph num="C."> <text>Providers may not bill for compliance activities more than once per participant per calendar year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payments for services rendered to a participant shall be made directly to the qualified lead entity.</text> </paragraph> <paragraph num="D."> <text>Effective January 1, 2025, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>$725 per member per month for ACIS housing and tenancy-based case management; and</text> </paragraph> <paragraph num="(2)"> <text>$100 per member per year for compliance activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement regulations are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 12, 2025 (52:9 Md. R. 405)</annotation> </annotations> </chapter> <chapter num="67" heading="Maryland Medicaid Managed Care Program: Benefits" reason="Transferred to COMAR 10.67.06"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.06 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="68" heading="Maryland Medicaid Managed Care Program: Program Integrity" reason="Transferred to COMAR 10.67.07"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.07 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="69" heading="Maryland Medicaid Managed Care Program: Rare and Expensive Case Management"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>The purpose of the Rare and Expensive Case Management (REM) program is to provide case management services and subspecialty care for Maryland Medicaid Managed Care Program eligible individuals with rare and expensive conditions.</text> </paragraph> <paragraph num="B."> <text>The program is designed to provide Maryland Medicaid Managed Care Program eligible individuals diagnosed with qualifying rare and expensive conditions the following benefits when the individual elects to participate in the program:</text> <paragraph num="(1)"> <text>Case management services; and</text> </paragraph> <paragraph num="(2)"> <text>REM optional services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means tasks or activities that include but are not limited to bathing, feeding, toileting, dressing, and ambulation.</text> </paragraph> <paragraph num="(2)"> <text>“Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> <paragraph num="(3)"> <text>“Caregiver” means a willing and able individual who is trained in providing care to the participant.</text> </paragraph> <paragraph num="(4)"> <text>“Case management” means assessing, planning, coordinating, and monitoring the delivery of medically necessary health-related services.</text> </paragraph> <paragraph num="(5)"> <text>“Case management provider” means the Department's designee, or a subcontractor of the designee, which provides case management to participants assigned to it by the Department.</text> </paragraph> <paragraph num="(6)"> <text>“Case manager” means, an individual who is:</text> <paragraph num="(a)"> <text>A social worker with active and nationally recognized certification in case management or an RN;</text> </paragraph> <paragraph num="(b)"> <text>Employed by the Department's designee; and</text> </paragraph> <paragraph num="(c)"> <text>Assigned by the Department's designee to manage the care of some or all of the participants.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Cause” means a significant change in medical condition such that it is no longer medically efficacious for the individual to remain in the MCO as determined by the Department.</text> </paragraph> <paragraph num="(8)"> <text>“Certified medication technician (CMT)” means an individual who:</text> <paragraph num="(a)"> <text>Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and</text> </paragraph> <paragraph num="(c)"> <text>Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Certified nursing assistant (CNA)” means an individual who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and</text> </paragraph> <paragraph num="(b)"> <text>Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Certified nursing assistant certified as a CMT (CNA-CMT)” means an individual who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.05 and 10.39.04;</text> </paragraph> <paragraph num="(b)"> <text>Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; and</text> </paragraph> <paragraph num="(c)"> <text>Routinely performs nursing tasks including medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Chiropractor” means an individual who is licensed by the Maryland State Board of Chiropractic Examiners to practice chiropractic in Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Delegated nursing services” means nursing services provided to a participant by a CNA, CNA-CMT, HHA, or HHA-CMT under the supervision of an RN in accordance with COMAR 10.27.11.</text> </paragraph> <paragraph num="(13)"> <text>“Dental service provider” means an individual who is licensed and legally authorized to practice dentistry in the state in which the service is provided.</text> </paragraph> <paragraph num="(14)"> <text>“Department” means the Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(15)"> <text>“Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services.</text> </paragraph> <paragraph num="(17)"> <text>“EPSDT-certified provider” means a physician, physician assistant or nurse practitioner who is certified by the Department's EPSDT program to provide well-child services according to the Department's periodicity schedule and program standards to enrollees younger than 21 years old.</text> </paragraph> <paragraph num="(18)"> <text>“EPSDT periodicity schedule” means the list approved by the Department of required or recommended preventive health care services for children and adolescents.</text> </paragraph> <paragraph num="(19)"> <text>“EPSDT services” means:</text> <paragraph num="(a)"> <text>Screening services provided by an EPSDT-certified provider that are required or recommended on the EPSDT periodicity schedule; and</text> </paragraph> <paragraph num="(b)"> <text>Health care services performed to diagnose, treat, or refer problems or conditions discovered during the comprehensive well-child service.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Evaluation” means a determination of the health status of a patient in a patient's home or any other appropriate setting by a licensed professional for the purpose of designing an individual plan of care, which incorporates the modalities of treatment that will promote optimal functional ability and recuperation.</text> </paragraph> <paragraph num="(21)"> <text>“Family member” means an adult who:</text> <paragraph num="(a)"> <text>Lives with or provides care to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Is not paid to provide the care under the REM program.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“HealthChoice” means Maryland Medicaid's Statewide mandatory managed care program as defined in COMAR 10.67.04.</text> </paragraph> <paragraph num="(23)"> <text>“Home” means the place of residence, occupied by the participant, other than a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment.</text> </paragraph> <paragraph num="(24)"> <text>“Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10.</text> </paragraph> <paragraph num="(25)"> <text>“Home health aide (HHA)” means an individual who meets all the conditions of participation specified in:</text> <paragraph num="(a)"> <text>42 CFR §484.36; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Home health aide certified as a CMT (HHA-CMT)” means an individual who:</text> <paragraph num="(a)"> <text>Meets all the conditions of participation specified in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Hospital” means an institution licensed by and providing services in accordance with Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(28)"> <text>“Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child.</text> </paragraph> <paragraph num="(29)"> <text>“Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family developed by an IFSP team.</text> </paragraph> <paragraph num="(30)"> <text>“Interdisciplinary team" means the group comprised of the case manager and relevant service providers to develop the case management plan under the overall direction and coordination of the case manager, in consultation with the participant and, when applicable, the participant's family.</text> </paragraph> <paragraph num="(31)"> <text>“Intermediate care facility for individuals with intellectual disabilities or individuals with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions.</text> </paragraph> <paragraph num="(32)"> <text>“Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for categorically eligible and medically needy individuals.</text> </paragraph> <paragraph num="(35)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, the participant's family, or the provider.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Medicare” means the federal program that provides benefits to the aged and disabled under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(37)"> <text>“Nurse” means an individual who is licensed to practice as a registered nurse (RN) or a licensed practical nurse (LPN) in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(38)"> <text>“Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner in the jurisdiction in which services are provided.</text> </paragraph> <paragraph num="(39)"> <text>“Nursing facility” has the meaning stated in COMAR 10.09.10.01B.</text> </paragraph> <paragraph num="(40)"> <text>“Nutritional counseling” means the assessment of the participant's nutritional status and education about improving their nutritional status provided by a licensed dietitian-nutritionist.</text> </paragraph> <paragraph num="(41)"> <text>“Nutritional supplements” means enteral feeding which is medically indicated as either the sole source of nutrition or a supplement that enhances the physical well-being of the participant.</text> </paragraph> <paragraph num="(42)"> <text>“Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland.</text> </paragraph> <paragraph num="(43)"> <text>“Participant” means an eligible individual who is enrolled in the Program.</text> </paragraph> <paragraph num="(44)"> <text>“Physician” means an individual who is licensed or otherwise legally authorized to practice in the jurisdiction in which the services are rendered.</text> </paragraph> <paragraph num="(45)"> <text>“Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in the Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(46)"> <text>“Plan of care” means the document which governs a participant's care management which includes the:</text> <paragraph num="(a)"> <text>Case management assessment report;</text> </paragraph> <paragraph num="(b)"> <text>Interdisciplinary plan of care; and</text> </paragraph> <paragraph num="(c)"> <text>Case management plan.</text> </paragraph> </paragraph> <paragraph num="(47)"> <text>“Preauthorization” means the approval required from the Department or its designee before specific services may be rendered.</text> </paragraph> <paragraph num="(48)"> <text>“Primary care provider (PCP)” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.67.06.</text> </paragraph> <paragraph num="(49)"> <text>“Private duty nursing” means skilled nursing services for participants, who require more individual and continuous care than is available under the home health program, which are provided by a registered nurse (RN) or a licensed practical nurse (LPN), in a participant's home or another setting when normal life activities take the participant outside his or her home.</text> </paragraph> <paragraph num="(50)"> <text>“Program”, unless the context indicates otherwise, has the meaning stated in COMAR 10.09.36.01B.</text> </paragraph> <paragraph num="(51)"> <text>“Progress note” means a signed and dated written notation by the RN, LPN, CNA, CNA-CMT, HHA, or HHA-CMT, which:</text> <paragraph num="(a)"> <text>Summarizes facts about the care given and the participant's response during a given period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specifically addresses the established goals of treatment;</text> </paragraph> <paragraph num="(c)"> <text>Is consistent with the participant's plan of care; and</text> </paragraph> <paragraph num="(d)"> <text>Is written during the course of care.</text> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Provider” means an individual, agency, or facility, which is enrolled in the Program through an agreement with the Department, and has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(53)"> <text>“Rare and expensive case management (REM)” means a Maryland Medical Assistance program that provides case management services and optional services to eligible individuals with specific rare and expensive conditions.</text> </paragraph> <paragraph num="(54)"> <text>“Rare and expensive condition” means a medical diagnosis or condition identified in Regulation .16 of this chapter.</text> </paragraph> <paragraph num="(55)"> <text>“Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(56)"> <text>“REM optional services” means the services listed in Regulations .10 and .11 of this chapter, which meet the general requirements under Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(57)"> <text>“Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05.</text> </paragraph> <paragraph num="(58)"> <text>“Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided.</text> </paragraph> <paragraph num="(59)"> <text>“School” means courses or classes for the acquisition of a General Education Diploma, a high school diploma, an associate degree, or a first-time bachelor’s degree.</text> </paragraph> <paragraph num="(60)"> <text>“Social worker” means an individual who is licensed by the Maryland State Board of Social Work Examiners to practice social work in Maryland.</text> </paragraph> <paragraph num="(61)"> <text>“Speech-language pathologist” means an individual who is licensed by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech-language pathology in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="REM Eligibility."> <paragraph num="A."> <text>An individual is eligible to participate in the REM program if the individual:</text> <paragraph num="(1)"> <text>Is eligible for Maryland Medicaid Managed Care as specified in COMAR 10.67.02.01;</text> </paragraph> <paragraph num="(2)"> <text>Has one or more of the diagnoses specified in Regulation .17 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Elects to participate in the REM program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall render a determination of an individual's eligibility within 5 business days on receipt of:</text> <paragraph num="(1)"> <text>A completed REM application;</text> </paragraph> <paragraph num="(2)"> <text>Any requested documentation verifying an individual meets the criteria set forth in §A of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Verbal or written confirmation an individual elects to participate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participant Enrollment and Disenrollment."> <paragraph num="A."> <text>Anyone may refer an individual into the REM program including, but not limited to a:</text> <paragraph num="(1)"> <text>Family member;</text> </paragraph> <paragraph num="(2)"> <text>Physician;</text> </paragraph> <paragraph num="(3)"> <text>Discharge planner;</text> </paragraph> <paragraph num="(4)"> <text>Hospital;</text> </paragraph> <paragraph num="(5)"> <text>Clinic;</text> </paragraph> <paragraph num="(6)"> <text>Social worker; and</text> </paragraph> <paragraph num="(7)"> <text>Managed care organization (MCO).</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall enroll an individual determined eligible in the REM program when:</text> <paragraph num="(1)"> <text>All pertinent documentation regarding needed medical services is received, reviewed, and approved;</text> </paragraph> <paragraph num="(2)"> <text>Confirmation of the individual's election to participate in the program is received; and</text> </paragraph> <paragraph num="(3)"> <text>The individual is being discharged from an institution or transitioning from an MCO and service coordination is complete.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When an MCO participant is referred to the REM program for enrollment, the MCO shall:</text> <paragraph num="(1)"> <text>Provide confirmation of the qualifying diagnosis to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Continue to provide the MCO participant's care until the Department confirms the diagnosis and enrolls the MCO participant into REM.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual shall be enrolled in or auto-assigned into an MCO as specified in COMAR 10.67.02, not later than 60 days from the date the individual becomes ineligible for REM, as a result of changes in the diagnosis or age group criteria specified in Regulation .17 of this chapter, except when the individual was allowed to remain in REM in accordance with §I of this regulation.</text> </paragraph> <paragraph num="E."> <text>A REM participant may elect to disenroll from REM and enroll in an MCO by notifying the Department of that decision except when the individual was allowed to remain in REM in accordance with §I of this regulation.</text> </paragraph> <paragraph num="F."> <text>Election to Remain in MCO.</text> <paragraph num="(1)"> <text>An individual who becomes eligible for REM while enrolled in an MCO may elect to remain in an MCO by notifying the Department of that decision.</text> </paragraph> <paragraph num="(2)"> <text>When a REM-eligible individual elects to remain in an MCO, the Department, in consultation with the MCO and the REM-eligible individual, may determine whether the MCO can appropriately meet the individual's medical needs within the parameters of the program benefit package as described in COMAR 10.67.06.</text> </paragraph> <paragraph num="(3)"> <text>If the MCO determines it cannot appropriately meet the individual's medical needs, the MCO shall submit to the Department written justification for its decision.</text> </paragraph> <paragraph num="(4)"> <text>If the Department determines the MCO can meet the individual's medical needs, the Department shall notify the MCO of its decision in writing.</text> </paragraph> <paragraph num="(5)"> <text>If the Department determines that the MCO cannot appropriately meet the individual's needs, the Department shall issue a written determination to the individual and the MCO which includes:</text> <paragraph num="(a)"> <text>The reason for the determination; and</text> </paragraph> <paragraph num="(b)"> <text>An explanation of the individual's right to appeal the determination according to the procedures set forth in COMAR 10.01.04.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the Department determines that the MCO can appropriately meet the individual's medical needs, the individual's election becomes effective and cannot be revoked without cause for a period of 1 year from the effective date.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall allow an individual who, immediately before enrollment in REM, was receiving medical services from a specialty clinic or other setting to continue to receive services in that setting on enrollment in the REM program when the provider is willing to participate as a Medical Assistance fee-for-service provider.</text> </paragraph> <paragraph num="H."> <text>An individual eligible for REM who has elected to enroll in an MCO or to remain enrolled in an MCO may not receive REM services under the REM program.</text> </paragraph> <paragraph num="I."> <text>The Department shall disenroll from the REM program a participant who no longer meets the conditions specified in Regulation .03 of this chapter unless:</text> <paragraph num="(1)"> <text>The participant does not meet the condition under Regulation .03A(1) of this chapter because the participant becomes eligible for Medicare; and</text> </paragraph> <paragraph num="(2)"> <text>At the time the participant became eligible for Medicare the participant was approved for and was receiving private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services under the REM program.</text> </paragraph> </paragraph> <paragraph num="J."> <text>An individual disenrolled from REM by the Department who maintains HealthChoice eligibility is subject to the MCO enrollment provisions specified in COMAR 10.67.02 except when the individual was allowed to remain in REM in accordance with §I of this regulation.</text> </paragraph> <paragraph num="K."> <text>Department-Initiated Disenrollment. The Department shall disenroll from REM an enrollee:</text> <paragraph num="(1)"> <text>Who has been continuously institutionalized for a period of more than 90 successive days in a long-term care facility, subject to the long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Who has been, or is expected to be, continuously institutionalized for more than 30 successive days in an institution for mental disease (IMD);</text> </paragraph> <paragraph num="(3)"> <text>Upon admission to an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID);</text> </paragraph> <paragraph num="(4)"> <text>Who loses Medicaid eligibility or who changes to an assistance category not eligible for MCO enrollment, subject to COMAR 10.67.02;</text> </paragraph> <paragraph num="(5)"> <text>Who has died; or</text> </paragraph> <paragraph num="(6)"> <text>Who is an inmate of a public institution, including a State-operated institution or facility.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Effective Date of Disenrollment. An enrollee’s disenrollment shall take effect:</text> <paragraph num="(1)"> <text>Immediately when the enrollee dies;</text> </paragraph> <paragraph num="(2)"> <text>From the first day of the month following the month in which the enrollee lost Medicaid eligibility;</text> </paragraph> <paragraph num="(3)"> <text>On the first day of the month following the month in which the Department receives the required notification, when the enrollee permanently relocates outside of the State; or</text> </paragraph> <paragraph num="(4)"> <text>From the first day of the month following the month in which the Department verifies an enrollee is an inmate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Benefits."> <text>A REM participant is eligible for the following:</text> <paragraph num="A."> <text>Fee-for-service Medical Assistance benefits available to a Medical Assistance participant not enrolled in an MCO;</text> </paragraph> <paragraph num="B."> <text>Services described in Regulations .10 and .11 of this chapter when determined medically necessary by the Department;</text> </paragraph> <paragraph num="C."> <text>A case management assessment performed by a REM case manager who shall:</text> <paragraph num="(1)"> <text>Gather all relevant information needed to determine the participant’s condition and needs including the participant’s medical records;</text> </paragraph> <paragraph num="(2)"> <text>Consult with the participant's current service providers; and</text> </paragraph> <paragraph num="(3)"> <text>Evaluate the relevant information and complete a needs analysis including medical, psychosocial, environmental, and functional assessments; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Case management services performed by a REM case manager who shall:</text> <paragraph num="(1)"> <text>When necessary, assist the REM participant, offering the participant a choice, if possible, in selecting and obtaining a PCP, who may be a specialist to the participant’s condition, giving preference to any pre-established relationships between the participant and the participant’s PCP;</text> </paragraph> <paragraph num="(2)"> <text>Develop a plan of care in consultation with the participant, the participant's family members as authorized by the participant when possible, the PCP, and other providers rendering care that:</text> <paragraph num="(a)"> <text>Includes the participant's health status and needs for medical, health-related, housing, and social services including, but not limited to:</text> <paragraph num="(i)"> <text>All pertinent diagnoses including the REM qualifying diagnosis;</text> </paragraph> <paragraph num="(ii)"> <text>Type, frequency, and duration of services;</text> </paragraph> <paragraph num="(iii)"> <text>Treatment goals for each type of service;</text> </paragraph> <paragraph num="(iv)"> <text>Medical equipment and supplies;</text> </paragraph> <paragraph num="(v)"> <text>Medication;</text> </paragraph> <paragraph num="(vi)"> <text>Social support structure;</text> </paragraph> <paragraph num="(vii)"> <text>Current service providers;</text> </paragraph> <paragraph num="(viii)"> <text>Assigned level of care;</text> </paragraph> <paragraph num="(ix)"> <text>Nutritional status;</text> </paragraph> <paragraph num="(x)"> <text>Education or vocational information;</text> </paragraph> <paragraph num="(xi)"> <text>Current living arrangement; and</text> </paragraph> <paragraph num="(xii)"> <text>Emergency plan, if appropriate; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is developed in consultation with the interdisciplinary team;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Implement the plan of care and assist the participant in gaining access to medically necessary services by linking the participant to those services;</text> </paragraph> <paragraph num="(4)"> <text>Monitor service delivery, perform record reviews, and maintain contacts with the participant, services providers, and family members to evaluate the participant's condition and progress and to determine whether revision is needed in the plan of care or in services' delivery;</text> </paragraph> <paragraph num="(5)"> <text>As necessary, initiate and implement modifications to the plan of care and communicate these changes to the participant, parents or caregivers, and pertinent health care providers;</text> </paragraph> <paragraph num="(6)"> <text>Monitor a participant's receipt of EPSDT services as specified in COMAR 10.67.06; and</text> </paragraph> <paragraph num="(7)"> <text>Assist the participant with the coordination of school health-related services such as the IEP or the IFSP as described in COMAR 10.09.50.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Requirements for Provider Qualification."> <paragraph num="A."> <text>A case manager providing case management under this chapter shall be:</text> <paragraph num="(1)"> <text>An RN; or</text> </paragraph> <paragraph num="(2)"> <text>A social worker.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following professionals providing services under this chapter to REM participants shall be licensed, certified, or otherwise legally authorized to practice in the jurisdiction in which the services are rendered:</text> <paragraph num="(1)"> <text>Physicians;</text> </paragraph> <paragraph num="(2)"> <text>Physician Assistants;</text> </paragraph> <paragraph num="(3)"> <text>Nurse Practitioners;</text> </paragraph> <paragraph num="(4)"> <text>RNs and LPNs;</text> </paragraph> <paragraph num="(5)"> <text>Chiropractors;</text> </paragraph> <paragraph num="(6)"> <text>Dentists;</text> </paragraph> <paragraph num="(7)"> <text>Dietitian-Nutritionists;</text> </paragraph> <paragraph num="(8)"> <text>Occupational therapists;</text> </paragraph> <paragraph num="(9)"> <text>Social workers;</text> </paragraph> <paragraph num="(10)"> <text>Speech-language pathologists; and</text> </paragraph> <paragraph num="(11)"> <text>CNAs, HHAs, CNA-CMTs, and HHA-CMTs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A provider rendering services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the provider is providing services.</text> </paragraph> <paragraph num="D."> <text>A provider rendering services to REM participants, pursuant to this chapter, may not have current sanctions or current disciplinary actions imposed by:</text> <paragraph num="(1)"> <text>The jurisdictional licensing or certification authority;</text> </paragraph> <paragraph num="(2)"> <text>The Medicare Program;</text> </paragraph> <paragraph num="(3)"> <text>The Program; or</text> </paragraph> <paragraph num="(4)"> <text>Other federally funded healthcare programs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Conditions for Participation — General Requirements."> <text>A provider rendering services pursuant to this chapter shall:</text> <paragraph num="A."> <text>Meet the applicable conditions for participation set forth in COMAR 10.09.36;</text> </paragraph> <paragraph num="B."> <text>Meet the provider qualification requirements specified in Regulation .06 of this chapter for its provider type;</text> </paragraph> <paragraph num="C."> <text>Meet the specific conditions for provider participation set forth in this chapter;</text> </paragraph> <paragraph num="D."> <text>Provide services in accordance with the applicable requirements of this chapter and all other relevant State and local laws and regulations;</text> </paragraph> <paragraph num="E."> <text>Verify the qualifications of all subcontracted or employed professionals and individuals engaged by the provider agency to render services covered under this chapter and provide a copy of their current licensure and credentials on request to the Department;</text> </paragraph> <paragraph num="F."> <text>Provide services to REM program participants in a manner consistent with the REM participant’s plan of care; and</text> </paragraph> <paragraph num="G."> <text>When the Department determines it is necessary, participate in the interdisciplinary team meetings for the purpose of:</text> <paragraph num="(1)"> <text>Developing and implementing a participant's treatment plan or plan of care with the Department; or</text> </paragraph> <paragraph num="(2)"> <text>Accessing a specific service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for Provider Participation."> <paragraph num="A."> <text>Case Management Providers. To participate in the Program, a case management provider shall meet the conditions set forth in Regulations .06 and .07 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Chiropractic Service Providers. To participate in the Program, the chiropractic service provider shall:</text> <paragraph num="(1)"> <text>Meet the:</text> <paragraph num="(a)"> <text>Conditions set forth in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Requirements for chiropractic providers specified in COMAR 10.43.04;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Develop a goal-directed treatment plan that is based on an evaluation conducted during the initial assessment, which requires:</text> <paragraph num="(a)"> <text>A review or evaluation of the treatment plan 30 days after the initial assessment; and</text> </paragraph> <paragraph num="(b)"> <text>A review and update of the treatment plan every 90 days; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Render services in accordance with orders written by a physician, physician assistant, or nurse practitioner.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Dental Service Providers. To participate in the Program, the dental service provider shall meet the:</text> <paragraph num="(1)"> <text>Conditions set forth in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Requirements for dental providers specified in COMAR 10.09.05.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nutritional Supplement Providers. To participate as a provider of nutritional supplements, a provider shall meet the:</text> <paragraph num="(1)"> <text>Conditions of participation as set forth in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Criteria of the conditions for participation for pharmacy providers set forth in COMAR 10.09.03.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Shift Private Duty Nursing/CNA/CNA-CMT/HHA/HHA-CMT Providers. To participate as a provider agency for shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services, a provider shall:</text> <paragraph num="(1)"> <text>Meet the conditions set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Meet all requirements of conditions for participation set forth in COMAR 10.09.53.03;</text> </paragraph> <paragraph num="(3)"> <text>Participate in interdisciplinary team meetings, when requested by the Department or its designee;</text> </paragraph> <paragraph num="(4)"> <text>Develop a goal-directed written nursing care plan that is based on an evaluation conducted during the initial assessment, which requires:</text> <paragraph num="(a)"> <text>A review or evaluation of the nursing care plan 30 days after the initial assessment; and</text> </paragraph> <paragraph num="(b)"> <text>A review and update of the nursing care plan every 90 days;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Ensure timesheets are signed by the individual rendering services;</text> </paragraph> <paragraph num="(6)"> <text>Ensure a nurse's, CNA’s, CNA-CMT’s, HHA’s, or HHA-CMT’s shift to be not more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Obtain the participant's signature or the signature of the participant's witness on the provider's official forms to verify receipt of service; and</text> </paragraph> <paragraph num="(8)"> <text>Be licensed as a:</text> <paragraph num="(a)"> <text>Residential service agency in accordance with COMAR 10.07.05; or</text> </paragraph> <paragraph num="(b)"> <text>Home health agency in accordance with COMAR 10.07.10 which meets the conditions of participation specified by the Medicare program in 42 CFR §484.36.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Occupational Therapy Providers. To participate in the Program as a provider of occupational therapy services, a provider shall:</text> <paragraph num="(1)"> <text>Meet the conditions set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Be a self-employed occupational therapist licensed according to COMAR 10.46.01;</text> </paragraph> <paragraph num="(3)"> <text>Be an agency or clinic which employs occupational therapists or be a Program provider of home health services under COMAR 10.09.04; and</text> </paragraph> <paragraph num="(4)"> <text>Develop a goal-directed written treatment plan that is based on an evaluation conducted during the initial assessment which requires:</text> <paragraph num="(a)"> <text>A review or evaluation of the treatment plan 30 days after the initial assessment; and</text> </paragraph> <paragraph num="(b)"> <text>A review and update of the treatment plan every 90 days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Speech-Language Pathology Providers. To participate in the Program, a speech-language pathology provider shall:</text> <paragraph num="(1)"> <text>Meet the conditions set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Be a self-employed speech-language pathologist according to COMAR 10.41.03 or be a Program provider of home health services under COMAR 10.09.04;</text> </paragraph> <paragraph num="(3)"> <text>Be an agency or clinic that employs speech-language pathologists; and</text> </paragraph> <paragraph num="(4)"> <text>Develop a goal-directed written treatment plan that is based on an initial assessment, which requires:</text> <paragraph num="(a)"> <text>A review or evaluation of the treatment plan 30 days after the initial assessment; and</text> </paragraph> <paragraph num="(b)"> <text>A review and update of the treatment plan every 90 days.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services — General Requirements."> <text>For participants in the REM program, the Program covers and shall reimburse for services specified in Regulations .10 and .11 of this chapter when these services are:</text> <paragraph num="A."> <text>Medically necessary;</text> </paragraph> <paragraph num="B."> <text>Prescribed by a:</text> <paragraph num="(1)"> <text>Physician;</text> </paragraph> <paragraph num="(2)"> <text>Physician assistant; or</text> </paragraph> <paragraph num="(3)"> <text>Nurse practitioner;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Preauthorized, when required, by the Department;</text> </paragraph> <paragraph num="D."> <text>Rendered in accordance with accepted health professional standards;</text> </paragraph> <paragraph num="E."> <text>Rendered in accordance with the treatment plan or physician's, physician assistant’s, or nurse practitioner’s order, or both; and</text> </paragraph> <paragraph num="F."> <text>Delivered by an enrolled Medical Assistance provider.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Covered Services."> <paragraph num="A."> <text>Chiropractic services are covered for REM participants when:</text> <paragraph num="(1)"> <text>Services are provided to a REM participant who is 21 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Services are provided by a physician or chiropractor;</text> </paragraph> <paragraph num="(3)"> <text>The qualifying REM diagnosis or related illness shows deterioration or worsening symptoms and other traditional treatments have been ineffective;</text> </paragraph> <paragraph num="(4)"> <text>The treatment enhances or restores the participant's level of functioning; or</text> </paragraph> <paragraph num="(5)"> <text>Symptoms resulting from the REM diagnosis or related illness impairs a participant's activities of daily living.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Dental services are covered when services are:</text> <paragraph num="(1)"> <text>Provided to a REM participant who is 21 years old or older; and</text> </paragraph> <paragraph num="(2)"> <text>Rendered as specified in COMAR 10.09.05.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nutritional counseling services are covered when services are provided:</text> <paragraph num="(1)"> <text>To a REM participant who is 21 years old or older; and</text> </paragraph> <paragraph num="(2)"> <text>By a dietitian-nutritionist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nutritional supplements are covered when the services:</text> <paragraph num="(1)"> <text>Include nutritional supplements or enteral feeding when medically necessary other than those administered by tube; and</text> </paragraph> <paragraph num="(2)"> <text>Are as described in COMAR 10.09.03.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall cover a physician's, physician assistant’s, or nurse practitioner’s participation at interdisciplinary team meetings when the case manager, in conjunction with the team or specific team members, convenes the team meeting for the purpose of developing or reviewing the REM participant's plan of care to ensure continuity of care or access to a specific service.</text> </paragraph> <paragraph num="F."> <text>Occupational therapy services are covered when services are provided:</text> <paragraph num="(1)"> <text>To a REM participant who is 21 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>By an occupational therapist; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with COMAR 10.46.01 and 10.46.02.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Speech-language pathology services include only those services that are provided:</text> <paragraph num="(1)"> <text>To a REM participant who is 21 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>By a speech-language pathologist; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with COMAR 10.41.02 and 10.41.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Optional Services — Private Duty Nursing, Certified Nursing Assistant, Certified Nursing Assistant Certified as a Certified Medication Technician, Home Health Aide and Home Health Aide Certified as a Certified Medication Technician."> <paragraph num="A."> <text>The Program shall cover shift nursing services provided by an RN or LPN when:</text> <paragraph num="(1)"> <text>The services are more individualized and continuous than what is available under the home health program;</text> </paragraph> <paragraph num="(2)"> <text>The services are delivered to the participant in the participant's home, in school, or in other normal life activity setting or settings which occur outside the participant's home;</text> </paragraph> <paragraph num="(3)"> <text>Services are provided to a REM participant who is 21 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver;</text> </paragraph> <paragraph num="(5)"> <text>The participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available;</text> </paragraph> <paragraph num="(6)"> <text>The caregiver provides documentation of each of the following when applicable:</text> <paragraph num="(a)"> <text>The caregiver’s work schedule along with commuting times;</text> </paragraph> <paragraph num="(b)"> <text>The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and</text> </paragraph> <paragraph num="(c)"> <text>Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Services are provided only in the absence of the willing and able caregiver during the sleeping hours and during the times documented in §A(6) of this regulation;</text> </paragraph> <paragraph num="(8)"> <text>Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Sufficient documentation concerning the services provided is maintained by the RN or LPN including:</text> <paragraph num="(a)"> <text>Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and</text> </paragraph> <paragraph num="(b)"> <text>Signed and dated progress notes which are reviewed monthly by the RN supervisor;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The nurse's shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the nurse is off 8 or more hours before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(11)"> <text>Services are rendered by an RN or an LPN who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; and</text> </paragraph> <paragraph num="(12)"> <text>Monthly supervisory visits of an RN or an LPN are:</text> <paragraph num="(a)"> <text>Conducted and documented by an RN supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>Based on acceptable standards of practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall cover service`s provided by a CNA or CNA-CMT when:</text> <paragraph num="(1)"> <text>The CNA or CNA-CMT is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The CNA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT;</text> </paragraph> <paragraph num="(3)"> <text>Services are of a scope that is more individual and continuous than what is available under the home health program;</text> </paragraph> <paragraph num="(4)"> <text>The services provided include but are not limited to:</text> <paragraph num="(a)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or</text> </paragraph> <paragraph num="(b)"> <text>Other health care services properly delegated by an RN or an LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Services are rendered by a CNA or CNA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years;</text> </paragraph> <paragraph num="(6)"> <text>The CNAs or CNA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the CNA or CNA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Sufficient documentation concerning the services provided is maintained by the CNA or CNA-CMT including:</text> <paragraph num="(a)"> <text>Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and</text> </paragraph> <paragraph num="(b)"> <text>Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Supervisory visits are conducted and documented every 2 weeks by an RN;</text> </paragraph> <paragraph num="(9)"> <text>The services are included in the REM participant's plan of care developed by the case manager; and</text> </paragraph> <paragraph num="(10)"> <text>Services are preauthorized by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall cover services provided by a HHA or HHA-CMT when:</text> <paragraph num="(1)"> <text>Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The HHA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT;</text> </paragraph> <paragraph num="(3)"> <text>Services are more individualized and continuous than what is available under the home health program;</text> </paragraph> <paragraph num="(4)"> <text>The services provided include but are not limited to:</text> <paragraph num="(a)"> <text>Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or</text> </paragraph> <paragraph num="(b)"> <text>Other health care services properly delegated by an RN or LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Services are rendered by a HHA or HHA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years;</text> </paragraph> <paragraph num="(6)"> <text>The HHAs or HHA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the HHA or HHA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Sufficient documentation is maintained by the HHA or HHA-CMT including:</text> <paragraph num="(a)"> <text>Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and</text> </paragraph> <paragraph num="(b)"> <text>Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Supervisory visits are conducted and documented every 2 weeks by an RN;</text> </paragraph> <paragraph num="(9)"> <text>The services are included in the REM participant's plan of care developed by the case manager; and</text> </paragraph> <paragraph num="(10)"> <text>Services are preauthorized by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Limitations."> <paragraph num="A."> <text>The Department shall pay for services specified in this chapter delivered to a REM participant only if the services have been ordered by the participant's physician or nurse practitioner, and preauthorized, when necessary, by the Department or its designee.</text> </paragraph> <paragraph num="B."> <text>For REM participants, the Department may not pay for the following comparable case management services:</text> <paragraph num="(1)"> <text>HIV targeted case management as described in COMAR 10.09.32, except for HIV Diagnostic Evaluation Services as described in COMAR 10.09.32.03C and .04A; and</text> </paragraph> <paragraph num="(2)"> <text>Model Waiver case management as described in COMAR 10.09.27.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The REM program does not cover the following:</text> <paragraph num="(1)"> <text>Shift private duty nursing, CNA or CNA-CMT, or HHA or HHA-CMT services rendered by a nurse, CNA, HHA, CNA-CMT, or HHA-CMT who is a member of the participant's immediate family or who ordinarily resides with the participant;</text> </paragraph> <paragraph num="(2)"> <text>Services which are not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Services not supervised by an RN when delivered by the following:</text> <paragraph num="(a)"> <text>An RN or an LPN;</text> </paragraph> <paragraph num="(b)"> <text>A CNA;</text> </paragraph> <paragraph num="(c)"> <text>An HHA;</text> </paragraph> <paragraph num="(d)"> <text>A CNA-CMT; or</text> </paragraph> <paragraph num="(e)"> <text>An HHA-CMT.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>REM optional services not preauthorized as required by the Department or its designee;</text> </paragraph> <paragraph num="(5)"> <text>REM optional services not prescribed by the participant's physician, physician assistant, or nurse practitioner;</text> </paragraph> <paragraph num="(6)"> <text>Services specified in this chapter which duplicate or supplant services rendered by the participant's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or Program services that the participant receives or is eligible to receive;</text> </paragraph> <paragraph num="(7)"> <text>Services provided for the convenience or preference of the participant or the primary caregiver rather than required by the participant's medical condition;</text> </paragraph> <paragraph num="(8)"> <text>Speech, language, or occupational therapy services rendered in a classroom setting;</text> </paragraph> <paragraph num="(9)"> <text>Shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services ordered by a physician assistant;</text> </paragraph> <paragraph num="(10)"> <text>Custodial services;</text> </paragraph> <paragraph num="(11)"> <text>Services provided to a participant in a:</text> <paragraph num="(a)"> <text>Hospital;</text> </paragraph> <paragraph num="(b)"> <text>Residential treatment center;</text> </paragraph> <paragraph num="(c)"> <text>Intermediate care facility for individuals with intellectual disabilities; or</text> </paragraph> <paragraph num="(d)"> <text>Residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Services not directly related to the participant’s plan of care;</text> </paragraph> <paragraph num="(13)"> <text>Services described in the plan of care whenever a major change occurs in the participant's medical condition or skilled nursing care needs that indicates such services are no longer necessary;</text> </paragraph> <paragraph num="(14)"> <text>Services which are not initially ordered before the start of care and renewed every 60 days by the participant’s primary medical provider;</text> </paragraph> <paragraph num="(15)"> <text>Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which nursing services are rendered;</text> </paragraph> <paragraph num="(16)"> <text>Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered;</text> </paragraph> <paragraph num="(17)"> <text>Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11;</text> </paragraph> <paragraph num="(18)"> <text>Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff’s home;</text> </paragraph> <paragraph num="(19)"> <text>Services not documented; and</text> </paragraph> <paragraph num="(20)"> <text>Respite services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program shall only cover one-to-one nursing when a participant’s condition requires that level of service and shared services are not an option.</text> </paragraph> <paragraph num="E."> <text>The Program shall only cover nursing services ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Preauthorization Requirements."> <paragraph num="A."> <text>Except for initial assessments unless otherwise specified, preauthorization by the Department or its designee is required for all services under Regulations .10 and .11 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall issue preauthorization when the Department:</text> <paragraph num="(1)"> <text>Determines that services are medically necessary; and</text> </paragraph> <paragraph num="(2)"> <text>Authorizes the services before the initiation or continuance of the requested service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Authorization of services shall be rescinded by the Department or its designee when:</text> <paragraph num="(1)"> <text>The participant is admitted to a hospital, residential treatment center, nursing facility, or ICF/IID;</text> </paragraph> <paragraph num="(2)"> <text>The participant is no longer REM eligible;</text> </paragraph> <paragraph num="(3)"> <text>The Department determines the care is no longer medically necessary; or</text> </paragraph> <paragraph num="(4)"> <text>The participant dies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Payment Procedures — Request for Payment."> <paragraph num="A."> <text>A provider shall submit a request for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>The Department shall pay for covered services at the lower of:</text> <paragraph num="(1)"> <text>The lowest price, including negotiated contract prices, that is offered to any other purchaser for the same or similar service during the same time period, after extending to the Program all rebates, coupons, and negotiated discounts;</text> </paragraph> <paragraph num="(2)"> <text>The actual charge billed by the provider; or</text> </paragraph> <paragraph num="(3)"> <text>Any fee schedule developed for reimbursement of the same service provided under Medical Assistance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For dates of service from January 1, 2021, through June 30, 2022, the Department shall pay $445.86 for a case management assessment, as described in Regulation .05C of this chapter.</text> </paragraph> <paragraph num="E."> <text>For dates of service from January 1, 2021, through June 30, 2022, the Department shall make payments monthly for case management services at one of the rates specified below:</text> <paragraph num="(1)"> <text>Level of Care 1: $329.22;</text> </paragraph> <paragraph num="(2)"> <text>Level of Care 2: $196.22; or</text> </paragraph> <paragraph num="(3)"> <text>Level of Care 3: $103.56.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Effective July 1, 2022, the Department shall pay $463.69 for a case management assessment, as described in Regulation .05C of this chapter.</text> </paragraph> <paragraph num="G."> <text>Effective July 1, 2022, the Department shall make payments monthly for case management services at one of the rates specified below:</text> <paragraph num="(1)"> <text>Level of Care 1: $342.39;</text> </paragraph> <paragraph num="(2)"> <text>Level of Care 2: $204.07; or</text> </paragraph> <paragraph num="(3)"> <text>Level of Care 3: $107.70.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The rates found in §§E and G of this regulation are the monthly rates paid by the Department for a participant receiving case management as follows:</text> <paragraph num="(1)"> <text>Level of Care 1 is intensive level of case management, assessment, and coordination of services for a participant who:</text> <paragraph num="(a)"> <text>Is acutely ill;</text> </paragraph> <paragraph num="(b)"> <text>Has an unstable clinical condition;</text> </paragraph> <paragraph num="(c)"> <text>Has an exacerbated chronic illness; or</text> </paragraph> <paragraph num="(d)"> <text>Has a newly diagnosed condition;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Level of Care 2 is case management to a participant who has a history of exacerbations of medical issues requiring services on an ongoing basis to attain stable service or treatment plans; and</text> </paragraph> <paragraph num="(3)"> <text>Level of Care 3 is case management that is required on an ongoing basis to monitor a participant’s stability and treatment plans.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Table of Rare and Expensive Disease Diagnosis."> <text>ICD10 ICD 10 Description Age Limit B20 Human immunodeficiency virus (HIV) disease 0—20 C96.0 Multifocal and multisystemic Langerhans-cell histiocytosis 0—64 C96.5 Multifocal and unisystemic Langerhans-cell histiocytosis 0—64 C96.6 Unifocal Langerhans-cell histiocytosis 0—64 D61.01 Constitutional (pure) red blood cell aplasia 0—20 D61.09 Other constitutional aplastic anemia 0—20 D66 Hereditary factor VIII deficiency 0—64 D67 Hereditary factor IX deficiency 0—64 D68.00 Von Willebrand disease, unspecified 0—64 D68.01 Von Willebrand disease, type 1 0—64 D68.020 Von Willebrand disease, type 2A 0—64 D68.021 Von Willebrand disease, type 2B 0—64 D68.022 Von Willebrand disease, type 2M 0—64 D68.023 Von Willebrand disease, type 2N 0—64 D68.029 Von Willebrand disease, type 2, unspecified 0—64 D68.03 Von Willebrand disease, type 3 0—64 D68.04 Acquired von Willebrand disease 0—64 D68.09 Other von Willebrand disease 0—64 D68.1 Hereditary factor XI deficiency 0—64 D68.2 Hereditary deficiency of other clotting factors 0—64 E70.0 Classical phenylketonuria 0—20 E70.1 Other hyperphenylalaninemias 0—20 E70.20 Disorder of tyrosine metabolism, unspecified 0—20 E70.21 Tyrosinemia 0—20 E70.29 Other disorders of tyrosine metabolism 0—20 E70.30 Albinism, unspecified 0—20 E70.40 Disorders of histidine metabolism, unspecified 0—20 E70.41 Histidinemia 0—20 E70.49 Other disorders of histidine metabolism 0—20 E70.5 Disorders of tryptophan metabolism 0—20 E70.81 Aromatic L-amino acid decarboxylase deficiency 0—20 E70.89 Other disorders of amino-acid metabolism 0—20 E71.110 Isovaleric acidemia 0—20 E71.111 3-methylglutaconic aciduria 0—20 E71.118 Other branched-chain organic acidurias 0—20 E71.120 Methylmalonic acidemia 0—20 E71.121 Propionic acidemia 0—20 E71.128 Other disorders of propionate metabolism 0—20 E71.19 Other disorders of branched-chain amino-acid metabolism 0—20 E71.2 Disorder of branched-chain amino-acid metabolism, unspecified 0—20 E71.310 Long chain/very long chain acyl CoA dehydrogenase deficiency 0—64 E71.311 Medium chain acyl CoA dehydrogenase deficiency 0—64 E71.312 Short chain acyl CoA dehydrogenase deficiency 0—64 E71.313 Glutaric aciduria type II 0—64 E71.314 Muscle carnitine palmitoyltransferase deficiency 0—64 E71.318 Other disorders of fatty-acid oxidation 0—64 E71.32 Disorders of ketone metabolism 0—64 E71.39 Other disorders of fatty-acid metabolism 0—64 E71.41 Primary carnitine deficiency 0—64 E71.42 Carnitine deficiency due to inborn errors of metabolism 0—64 E71.50 Peroxisomal disorder, unspecified 0—64 E71.510 Zellweger syndrome 0—64 E71.511 Neonatal adrenoleukodystrophy 0—64 E71.518 Other disorders of peroxisome biogenesis 0—64 E71.520 Childhood cerebral X-linked adrenoleukodystrophy 0—64 E71.521 Adolescent X-linked adrenoleukodystrophy 0—64 E71.522 Adrenomyeloneuropathy 0—64 E71.528 Other X-linked adrenoleukodystrophy 0—64 E71.529 X-linked adrenoleukodystrophy, unspecified type 0—64 E71.53 Other group 2 peroxisomal disorders 0—64 E71.540 Rhizomelic chondrodysplasia punctata 0—64 E71.541 Zellweger-like syndrome 0—64 E71.542 Other group 3 peroxisomal disorders 0—64 E71.548 Other peroxisomal disorders 0—64 E72.01 Cystinuria 0—20 E72.02 Hartnup’s disease 0—20 E72.03 Lowe’s syndrome 0—20 E72.04 Cystinosis 0—20 E72.09 Other disorders of amino-acid transport 0—20 E72.11 Homocystinuria 0—20 E72.12 Methylenetetrahydrofolate reductase deficiency 0—20 E72.19 Other disorders of sulfur-bearing amino-acid metabolism 0—20 E72.20 Disorder of urea cycle metabolism, unspecified 0—20 E72.21 Argininemia 0—20 E72.22 Arginosuccinic aciduria 0—20 E72.23 Citrullinemia 0—20 E72.29 Other disorders of urea cycle metabolism 0—20 E72.3 Disorders of lysine and hydroxylysine metabolism 0—20 E72.4 Disorders of ornithine metabolism 0—20 E72.51 Non-ketotic hyperglycinemia 0—20 E72.52 Trimethylaminuria 0—20 E72.53 Primary hyperoxaluria 0—20 E72.59 Other disorders of glycine metabolism 0—20 E72.81 Disorders of gamma aminobutyric acid metabolism 0—20 E72.89 Other specified disorders of amino-acid metabolism 0—20 E74.00 Glycogen storage disease, unspecified 0—20 E74.01 von Gierke disease 0—20 E74.02 Pompe disease 0—20 E74.03 Cori disease 0—20 E74.04 McArdle disease 0—20 E74.09 Other glycogen storage disease 0—20 E74.12 Hereditary fructose intolerance 0—20 E74.19 Other disorders of fructose metabolism 0—20 E74.21 Galactosemia 0—20 E74.29 Other disorders of galactose metabolism 0—20 E74.4 Disorders of pyruvate metabolism and gluconeogenesis 0—20 E75.00 GM2 gangliosidosis, unspecified 0—20 E75.01 Sandhoff disease 0—20 E75.02 Tay-Sachs disease 0—20 E75.09 Other GM2 gangliosidosis 0—20 E75.10 Unspecified gangliosidosis 0—20 E75.11 Mucolipidosis IV 0—20 E75.19 Other gangliosidosis 0—20 E75.21 Fabry (-Anderson) disease 0—20 E75.22 Gaucher disease 0—20 E75.23 Krabbe disease 0—20 E75.242 Niemann-Pick disease type C 0—20 E75.243 Niemann-Pick disease type D 0—20 E75.244 Niemann-Pick disease type A/B 0—20 E75.25 Metachromatic leukodystrophy 0—20 E75.26 Sulfatase deficiency 0—20 E75.29 Other sphingolipidosis 0—20 E75.3 Sphingolipidosis, unspecified 0—20 E75.4 Neuronal ceroid lipofuscinosis 0—20 E75.5 Other lipid storage disorders 0—20 E76.01 Hurler’s syndrome 0—64 E76.02 Hurler-Scheie syndrome 0—64 E76.03 Scheie’s syndrome 0—64 E76.1 Mucopolysaccharidosis, type II 0—64 E76.210 Morquio A mucopolysaccharidoses 0—64 E76.211 Morquio B mucopolysaccharidoses 0—64 E76.219 Morquio mucopolysaccharidoses, unspecified 0—64 E76.22 Sanfilippo mucopolysaccharidoses 0—64 E76.29 Other mucopolysaccharidoses 0—64 E76.3 Mucopolysaccharidosis, unspecified 0—64 E76.8 Other disorders of glucosaminoglycan metabolism 0—64 E77.0 Defects in post-translational mod of lysosomal enzymes 0—20 E77.1 Defects in glycoprotein degradation 0—20 E77.8 Other disorders of glycoprotein metabolism 0—20 E79.1 Lesch-Nyhan syndrome 0—64 E79.2 Myoadenylate deaminase deficiency 0—64 E79.8 Other disorders of purine and pyrimidine metabolism 0—64 E79.9 Disorder of purine and pyrimidine metabolism, unspecified 0—64 E80.3 Defects of catalase and peroxidase 0—64 E84.0 Cystic fibrosis with pulmonary manifestations 0—64 E84.11 Meconium ileus in cystic fibrosis 0—64 E84.19 Cystic fibrosis with other intestinal manifestations 0—64 E84.8 Cystic fibrosis with other manifestations 0—64 E84.9 Cystic fibrosis, unspecified 0—64 E88.40 Mitochondrial metabolism disorder, unspecified 0—64 E88.41 MELAS syndrome 0—64 E88.42 MERRF syndrome 0—64 E88.49 Other mitochondrial metabolism disorders 0—64 E88.89 Other specified metabolic disorders 0—64 F84.2 Rett’s syndrome 0—20 G11.0 Congenital nonprogressive ataxia 0—20 G11.10 Early-onset cerebellar ataxia, unspecified 0—20 G11.11 Friedreich ataxia 0—20 G11.19 Other early-onset cerebellar ataxia 0—20 G11.2 Late-onset cerebellar ataxia 0—20 G11.3 Cerebellar ataxia with defective DNA repair 0—20 G11.4 Hereditary spastic paraplegia 0—20 G11.8 Other hereditary ataxias 0—20 G11.9 Hereditary ataxia, unspecified 0—20 G12.0 Infantile spinal muscular atrophy, type I (Werdnig-Hoffman) 0—20 G12.1 Other inherited spinal muscular atrophy 0—20 G12.21 Amyotrophic lateral sclerosis 0—20 G12.22 Progressive bulbar palsy 0—20 G12.29 Other motor neuron disease 0—20 G12.8 Other spinal muscular atrophies and related syndromes 0—20 G12.9 Spinal muscular atrophy, unspecified 0—20 G24.1 Genetic torsion dystonia 0—64 G24.8 Other dystonia 0—64 G25.3 Myoclonus 0—5 G25.9 Extrapyramidal and movement disorder, unspecified 0—20 G31.81 Alpers disease 0—20 G31.82 Leigh’s disease 0—20 G31.9 Degenerative disease of nervous system, unspecified 0—20 G32.81 Cerebellar ataxia in diseases classified elsewhere 0—20 G37.0 Diffuse sclerosis of central nervous system 0—64 G37.5 Concentric sclerosis (Balo) of central nervous system 0—64 G71.00 Muscular dystrophy, unspecified 0—64 G71.01 Duchenne or Becker muscular dystrophy 0—64 G71.02 Facioscapulohumeral muscular dystrophy 0—64 G71.031 Autosomal dominant limb girdle muscular dystrophy 0—64 G71.032 Autosomal recessive limb girdle muscular dystrophy due to calpain-3 dysfunction 0—64 G71.033 Limb girdle muscular dystrophy due to dysferlin dysfunction 0—64 G71.0340 Limb girdle muscular dystrophy due to sarcoglycan dysfunction, unspecified 0—64 G71.0341 Limb girdle muscular dystrophy due to alpha sarcoglycan dysfunction 0—64 G71.0342 Limb girdle muscular dystrophy due to beta sarcoglycan dysfunction 0—64 G71.0349 Limb girdle muscular dystrophy due to other sarcoglycan dysfunction 0—64 G71.035 Limb girdle muscular dystrophy due to anoctamin-5 dysfunction 0—64 G71.038 Other limb girdle muscular dystrophy 0—64 G71.039 Limb girdle muscular dystrophy, unspecified 0—64 G71.09 Other specified muscular dystrophies 0—64 G71.11 Myotonic muscular dystrophy 0—64 G71.20 Congenital myopathy, unspecified 0—64 G71.21 Nemaline myopathy 0—64 G71.220 Centronuclear myopathy 0—64 G71.228 Other centronuclear myopathy 0—64 G71.29 Other congenial myopathy 0—64 G80.0 Spastic quadriplegic cerebral palsy 0—64 G80.1 Spastic diplegic cerebral palsy 0—20 G80.3 Athetoid cerebral palsy 0—64 G82.50 Quadriplegia, unspecified 0—64 G82.51 Quadriplegia, C1-C4 complete 0—64 G82.52 Quadriplegia, C1-C4 incomplete 0—64 G82.53 Quadriplegia, C5-C7 complete 0—64 G82.54 Quadriplegia, C5-C7 incomplete 0—64 G91.0 Communicating hydrocephalus 0—20 G91.1 Obstructive hydrocephalus 0—20 I67.5 Moyamoya disease 0—64 K91.2 Postsurgical malabsorption, not elsewhere classified 0—20 N03.A Chronic nephritic syndrome with C3 glomerulonephritis 0—20 N03.1 Chronic nephritic syndrome with focal and segmental glomerular lesions 0—20 N03.2 Chronic nephritic syndrome w diffuse membranous glomrlneph 0—20 N03.3 Chronic neph syndrome w diffuse mesangial prolif glomrlneph 0—20 N03.4 Chronic neph syndrome w diffuse endocaplry prolif glomrlneph 0—20 N03.5 Chronic nephritic syndrome w diffuse mesangiocap glomrlneph 0—20 N03.6 Chronic nephritic syndrome with dense deposit disease 0—20 N03.7 Chronic nephritic syndrome w diffuse crescentic glomrlneph 0—20 N03.8 Chronic nephritic syndrome with other morphologic changes 0—20 N03.9 Chronic nephritic syndrome with unspecified morphologic changes 0—20 N08 Glomerular disorders in diseases classified elsewhere 0—20 N18.1 Chronic kidney disease, stage 1 0—20 N18.2 Chronic kidney disease, stage 2 (mild) 0—20 N18.30 Chronic kidney disease, stage 3, unspecified 0—20 N18.31 Chronic kidney disease, stage 3a 0—20 N18.32 Chronic kidney disease, stage 3b 0—20 N18.4 Chronic kidney disease, stage 4 (severe) 0—20 N18.5 Chronic kidney disease, stage 5 0—20 N18.6 End stage renal disease 0—20 N18.9 Chronic kidney disease, unspecified 0—20 Q01.9 Encephalocele, unspecified 0—20 Q02 Microcephaly 0—20 Q03.0 Malformations of aqueduct of Sylvius 0—20 Q03.1 Atresia of foramina of Magendie and Luschka 0—20 Q03.8 Other congenital hydrocephalus 0—20 Q03.9 Congenital hydrocephalus, unspecified 0—20 Q04.3 Other reduction deformities of brain 0—20 Q04.5 Megalencephaly 0—20 Q04.6 Congenital cerebral cysts 0—20 Q04.8 Other specified congenital malformations of brain 0—20 Q05.0 Cervical spina bifida with hydrocephalus 0—64 Q05.1 Thoracic spina bifida with hydrocephalus 0—64 Q05.2 Lumbar spina bifida with hydrocephalus 0—64 Q05.3 Sacral spina bifida with hydrocephalus 0—64 Q05.4 Unspecified spina bifida with hydrocephalus 0—64 Q05.5 Cervical spina bifida without hydrocephalus 0—64 Q05.6 Thoracic spina bifida without hydrocephalus 0—64 Q05.7 Lumbar spina bifida without hydrocephalus 0—64 Q05.8 Sacral spina bifida without hydrocephalus 0—64 Q05.9 Spina bifida, unspecified 0—64 Q06.0 Amyelia 0—64 Q06.1 Hypoplasia and dysplasia of spinal cord 0—64 Q06.2 Diastematomyelia 0—64 Q06.3 Other congenital cauda equina malformations 0—64 Q06.4 Hydromyelia 0—64 Q06.8 Other specified congenital malformations of spinal cord 0—64 Q07.01 Arnold-Chiari syndrome with spina bifida 0—64 Q07.02 Arnold-Chiari syndrome with hydrocephalus 0—64 Q07.03 Arnold-Chiari syndrome with spina bifida and hydrocephalus 0—64 Q30.1 Agenesis and underdevelopment of nose, cleft or absent nose only 0—5 Q30.2 Fissured, notched and cleft nose, cleft or absent nose only 0—5 Q31.0 Web of larynx 0—20 Q31.8 Other congenital malformations of larynx, atresia or agenesis of larynx only 0—20 Q32.1 Other congenital malformations of trachea, atresia or agenesis of trachea only 0—20 Q32.4 Other congenital malformations of bronchus, atresia or agenesis of bronchus only 0—20 Q33.0 Congenital cystic lung 0—20 Q33.2 Sequestration of lung 0—20 Q33.3 Agenesis of lung 0—20 Q33.6 Congenital hypoplasia and dysplasia of lung 0—20 Q35.1 Cleft hard palate 0—20 Q35.3 Cleft soft palate 0—20 Q35.5 Cleft hard palate with cleft soft palate 0—20 Q35.9 Cleft palate, unspecified 0—20 Q37.0 Cleft hard palate with bilateral cleft lip 0—20 Q37.1 Cleft hard palate with unilateral cleft lip 0—20 Q37.2 Cleft soft palate with bilateral cleft lip 0—20 Q37.3 Cleft soft palate with unilateral cleft lip 0—20 Q37.4 Cleft hard and soft palate with bilateral cleft lip 0—20 Q37.5 Cleft hard and soft palate with unilateral cleft lip 0—20 Q37.8 Unspecified cleft palate with bilateral cleft lip 0—20 Q37.9 Unspecified cleft palate with unilateral cleft lip 0—20 Q39.0 Atresia of esophagus without fistula 0—3 Q39.1 Atresia of esophagus with tracheo-esophageal fistula 0—3 Q39.2 Congenital tracheo-esophageal fistula without atresia 0—3 Q39.3 Congenital stenosis and stricture of esophagus 0—3 Q39.4 Esophageal web 0—3 Q42.0 Congenital absence, atresia and stenosis of rectum with fistula 0—5 Q42.1 Congen absence, atresia and stenosis of rectum without fistula 0—5 Q42.2 Congenital absence, atresia and stenosis of anus with fistula 0—5 Q42.3 Congenital absence, atresia and stenosis of anus without fistula 0—5 Q42.8 Congenital absence, atresia and stenosis of other parts of large intestine 0—5 Q42.9 Congenital absence, atresia and stenosis of large intestine, part unspecified 0—5 Q43.1 Hirschsprung’s disease 0—15 Q44.2 Atresia of bile ducts 0—20 Q44.3 Congenital stenosis and stricture of bile ducts 0—20 Q44.6 Cystic disease of liver 0—20 Q45.0 Agenesis, aplasia and hypoplasia of pancreas 0—5 Q45.1 Annular pancreas 0—5 Q45.3 Other congenital malformations of pancreas and pancreatic duct 0—5 Q45.8 Other specified congenital malformations of digestive system 0—10 Q60.1 Renal agenesis, bilateral 0—20 Q60.4 Renal hypoplasia, bilateral 0—20 Q60.6 Potter’s syndrome, with bilateral renal agenesis only 0—20 Q61.02 Congenital multiple renal cysts, bilateral only 0—20 Q61.19 Other polycystic kidney, infantile type, bilateral only 0—20 Q61.2 Polycystic kidney, adult type, bilateral only 0—20 Q61.3 Polycystic kidney, unspecified, bilateral only 0—20 Q61.4 Renal dysplasia, bilateral only 0—20 Q61.5 Medullary cystic kidney, bilateral only 0—20 Q61.9 Cystic kidney disease, unspecified, bilateral only 0—20 Q64.10 Exstrophy of urinary bladder, unspecified 0—20 Q64.12 Cloacal extrophy of urinary bladder 0—20 Q64.19 Other exstrophy of urinary bladder 0—20 Q75.0 Craniosynostosis 0—20 Q75.1 Craniofacial dysostosis 0—20 Q75.2 Hypertelorism 0—20 Q75.4 Mandibulofacial dysostosis 0—20 Q75.5 Oculomandibular dysostosis 0—20 Q75.8 Other congenital malformations of skull and face bones 0—20 Q77.4 Achondroplasia 0—1 Q77.6 Chondroectodermal dysplasia 0—1 Q77.8 Other osteochondrodysplasia with defects of growth of tubular bones and spine 0—1 Q78.0 Osteogenesis imperfecta 0—20 Q78.1 Polyostotic fibrous dysplasia 0—1 Q78.2 Osteopetrosis 0—1 Q78.3 Progressive diaphyseal dysplasia 0—1 Q78.4 Enchondromatosis 0—1 Q78.6 Multiple congenital exostoses 0—1 Q78.8 Other specified osteochondrodysplasias 0—1 Q78.9 Osteochondrodysplasia, unspecified 0—1 Q79.0 Congenital diaphragmatic hernia 0—1 Q79.1 Other congenital malformations of diaphragm 0—1 Q79.2 Exomphalos 0—1 Q79.3 Gastroschisis 0—1 Q79.4 Prune belly syndrome 0—1 Q79.59 Other congenital malformations of abdominal wall 0—1 Q89.7 Multiple congenital malformations, not elsewhere classified 0—10 R75 Inconclusive laboratory evidence of HIV 0—12 months Z21 Asymptomatic human immunodeficiency virus infection status 0—20 Z99.11 Dependence on respirator (ventilator) status 1—64 Z99.2 Dependence on renal dialysis 21—64</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Appeals Procedures."> <text>Appeal procedures are as set forth in COMAR 10.01.04 and 10.09.36.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103(b)(4)(i), and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .05, .06, .08—.11, and .13 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, and .14 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .09, .10, and .14 amended effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01O amended effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; repealed permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 repealed and new Regulations .01—.17 adopted effective February 2, 2004 (31:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C, D amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13C amended effective October 14, 2013 (40:20 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E, F, G adopted effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 repealed and new Regulation .17 adopted effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 2, 2018 (45:13 Md. R. 665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04K, L adopted effective November 23, 2023 (50:23 Md. R. 1005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14D, E amended effective May 20, 2019 (46:10 Md. R. 486); November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective May 20, 2019 (46:10 Md. R. 486); November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005)</annotation> </annotations> </chapter> <chapter num="70" heading="Maryland Medicaid Managed Care Program: Non-Capitated Covered Services" reason="Transferred to COMAR 10.67.08"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.08 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="71" heading="Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures" reason="Transferred to COMAR 10.67.09"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.09 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="72" heading="Maryland Medicaid Managed Care Program: Departmental Dispute Resolution Procedures" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, and .03 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C adopted effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, E amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> </annotations> </chapter> <chapter num="73" heading="Maryland Medicaid Managed Care Program: Sanctions" reason="Transferred to COMAR 10.67.10"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.10 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="74" heading="Maryland Medicaid Managed Care Program: Contribution to Graduate Medical Education Costs" reason="Transferred to COMAR 10.67.11"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.11 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="75" heading="Maryland Medicaid Managed Care Program: Corrective Managed Care" reason="Transferred to COMAR 10.67.12"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.12 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="76" heading="School-Based Health Centers (SBHC)"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(2)"> <text>“Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq., in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals younger than 21 years old.</text> </paragraph> <paragraph num="(3)"> <text>“Federally qualified health center (FQHC)” means an entity that has entered into an agreement with the Centers for Medicare and Medicaid Services (CMS) to meet Medicare requirements under 42 CFR §405.2464 and in accordance with 42 CFR §405.2401(b).</text> </paragraph> <paragraph num="(4)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice, dental practice, or both;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(7)"> <text>“Participant” means an individual who is certified as eligible for, and who is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(8)"> <text>“Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(9)"> <text>“Primary health services” means a basic level of health care, including diagnostic, treatment, consultative, referral, and preventive health services, generally rendered by:</text> <paragraph num="(a)"> <text>General practitioners;</text> </paragraph> <paragraph num="(b)"> <text>Family practitioners;</text> </paragraph> <paragraph num="(c)"> <text>Internists;</text> </paragraph> <paragraph num="(d)"> <text>Obstetricians;</text> </paragraph> <paragraph num="(e)"> <text>Gynecologists;</text> </paragraph> <paragraph num="(f)"> <text>Pediatricians;</text> </paragraph> <paragraph num="(g)"> <text>Physician assistants; and</text> </paragraph> <paragraph num="(h)"> <text>Nurse practitioners.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(11)"> <text>“Provider” means a school-based health center which has been approved by the Department.</text> </paragraph> <paragraph num="(12)"> <text>“School-based health center (SBHC)” means a health center that:</text> <paragraph num="(a)"> <text>Is located on school grounds;</text> </paragraph> <paragraph num="(b)"> <text>Provides on-site primary and preventive health care, referrals, and follow-up services;</text> </paragraph> <paragraph num="(c)"> <text>Could provide on-site dental care or behavioral health care, referrals, and follow-up services; and</text> </paragraph> <paragraph num="(d)"> <text>Has been approved by the Maryland Department of Health.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Specialty behavioral health” means services specified in COMAR 10.09.59.06 and 10.09.80.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A physician, nurse practitioner, or physician assistant providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided.</text> </paragraph> <paragraph num="C."> <text>A dentist or dental hygienist providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate as a Maryland Medicaid SBHC, a provider shall:</text> <paragraph num="(1)"> <text>Be approved by the Maryland Department of Health as an SBHC;</text> </paragraph> <paragraph num="(2)"> <text>Meet conditions for participation as a:</text> <paragraph num="(a)"> <text>Free-standing clinic as set forth in COMAR 10.09.08.03B;</text> </paragraph> <paragraph num="(b)"> <text>Physician as set forth in COMAR 10.09.02.03; or</text> </paragraph> <paragraph num="(c)"> <text>Nurse practitioner as set forth in COMAR 10.09.01.03.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide somatic health care services through health professionals who:</text> <paragraph num="(a)"> <text>Are trained and experienced in community health and providing health care services to school-aged children;</text> </paragraph> <paragraph num="(b)"> <text>Have knowledge of health promotion and illness prevention strategies for children and adolescents; and</text> </paragraph> <paragraph num="(c)"> <text>Are EPSDT certified;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ensure staff is assigned responsibilities consistent with the staff's education and experience and within the staff's scope of practice;</text> </paragraph> <paragraph num="(5)"> <text>Designate an individual to be responsible for overall management of the SBHC;</text> </paragraph> <paragraph num="(6)"> <text>Whenever comprehensive primary health services are being delivered, maintain a staffing pattern that includes at least one of the following on-site:</text> <paragraph num="(a)"> <text>A physician;</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner; or</text> </paragraph> <paragraph num="(c)"> <text>A physician assistant;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Maintain policies and procedures that ensure confidentiality of services and records which are practiced consistently, in accordance with Health-General Article, §4-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Maintain data collection and storage capabilities adequate to maintain medical records and standard demographic data;</text> </paragraph> <paragraph num="(9)"> <text>Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03; and</text> </paragraph> <paragraph num="(10)"> <text>Transmit a health visit report:</text> <paragraph num="(a)"> <text>To the student's MCO and PCP within 3 business days of the health visit, as designated by the Department, for inclusion in the student-participant's medical record; and</text> </paragraph> <paragraph num="(b)"> <text>If follow-up care with the PCP within 1 week of the health visit is required and the health visit report is mailed, to the student's MCO and PCP by telephone, email, or fax on the day of the SBHC visit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Specific requirements for participation in the Program as a dentist or dental hygienist in an SBHC are that a provider shall meet the conditions for participation as set forth in COMAR 10.09.05.03AE.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>An SBHC, designated by the Department as meeting the criteria specified in Regulation .03 of this chapter, is eligible for reimbursement by the Program for the following services:</text> <paragraph num="A."> <text>Comprehensive well-child care, including the administration of vaccines in accordance with the Maryland Healthy Kids Preventive Health Schedule, when:</text> <paragraph num="(1)"> <text>Performed by EPSDT certified providers; and</text> </paragraph> <paragraph num="(2)"> <text>Rendered according to EPSDT standards set forth in COMAR 10.09.23.03;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Follow-up of positive or abnormal EPSDT screening components without approval of the PCP, except when referral for specialty care is indicated;</text> </paragraph> <paragraph num="C."> <text>Comprehensive preventive and primary health services;</text> </paragraph> <paragraph num="D."> <text>Family planning services as described in COMAR 10.09.58.05;</text> </paragraph> <paragraph num="E."> <text>Covered dental services in accordance with COMAR 10.09.05;</text> </paragraph> <paragraph num="F."> <text>Specialty behavioral health services in accordance with COMAR 10.09.59 and 10.09.80; and</text> </paragraph> <paragraph num="G."> <text>Routine sports physicals.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not specified in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="D."> <text>Basic school health services as defined in COMAR 13A.05.05.05.15;</text> </paragraph> <paragraph num="E."> <text>Nursing or other health services provided as part of a participant's individualized educational program (IEP) as defined in COMAR 10.09.50.01B or individualized family service plan (IFSP) as defined in COMAR 10.09.50.01B;</text> </paragraph> <paragraph num="F."> <text>Skilled nursing services provided to enable a participant to be safely maintained in the school setting such as:</text> <paragraph num="(1)"> <text>Nasogastric tube feedings;</text> </paragraph> <paragraph num="(2)"> <text>Catheterization;</text> </paragraph> <paragraph num="(3)"> <text>Oral, nasotracheal, or tracheal suctioning; and</text> </paragraph> <paragraph num="(4)"> <text>Nebulizer treatments;</text> </paragraph> </paragraph> <paragraph num="G."> <text>School health services which are required in all school settings such as:</text> <paragraph num="(1)"> <text>Hearing and vision screening unless completed as part of an EPSDT well-child check-up;</text> </paragraph> <paragraph num="(2)"> <text>Routine assessment of minor injuries;</text> </paragraph> <paragraph num="(3)"> <text>First aid;</text> </paragraph> <paragraph num="(4)"> <text>Administration of medications including supervision of self-administered medications;</text> </paragraph> <paragraph num="(5)"> <text>General health promotion counseling; and</text> </paragraph> <paragraph num="(6)"> <text>Review of health records;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Vaccines supplied by Vaccines for Children (VFC);</text> </paragraph> <paragraph num="I."> <text>Visits for the sole purpose of:</text> <paragraph num="(1)"> <text>Administering medication;</text> </paragraph> <paragraph num="(2)"> <text>Checking blood pressure;</text> </paragraph> <paragraph num="(3)"> <text>Measuring weight;</text> </paragraph> <paragraph num="(4)"> <text>Interpreting lab results; or</text> </paragraph> <paragraph num="(5)"> <text>Group or individual health education; and</text> </paragraph> </paragraph> <paragraph num="J."> <text>Services provided outside of the physical location of the approved SBHC, unless services are rendered via telehealth in accordance with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reimbursement Methodology."> <paragraph num="A."> <text>The provider shall charge the Program the provider’s customary charge to the general public for similar services and charge the provider’s acquisition cost for injectable drugs or dispensed medical supplies.</text> </paragraph> <paragraph num="B."> <text>If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §B of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Local health department clinics, general clinics, physicians, and nurse practitioners shall be paid the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The maximum rates according to COMAR 10.09.02.07.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall reimburse an SBHC, sponsored by an LHD or general clinic, for dental services in accordance with COMAR 10.09.05.07.</text> </paragraph> <paragraph num="E."> <text>The Department shall reimburse an SBHC, sponsored by an LHD, general clinic, nurse practitioner, or physician, for specialty behavioral health services in accordance with COMAR 10.21.25 and 10.09.80.08.</text> </paragraph> <paragraph num="F."> <text>The Department shall reimburse an SBHC, sponsored by an FQHC, for services in accordance with COMAR 10.09.08.08.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit a completed request for payment in the format designated by the Department or HealthChoice MCO, including required documentation.</text> </paragraph> <paragraph num="B."> <text>The dental provider shall submit a request for payment in the format designated by the Department and in accordance with COMAR 10.09.05.07.</text> </paragraph> <paragraph num="C."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> <paragraph num="D."> <text>Unless the service is free to individuals not covered by Medicaid, a provider shall bill the Program the provider’s customary charge to the general public for similar services.</text> </paragraph> <paragraph num="E."> <text>The Department shall authorize payment on Medicare cross-over claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes a direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare determines the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions:</text> <paragraph num="(1)"> <text>A deductible shall be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Coinsurance shall be paid in full to FQHC providers.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An SBHC providing self–referred services as described in COMAR 10.67.06.28 to an MCO participant shall:</text> <paragraph num="(1)"> <text>Verify eligibility and MCO assignment through EVS on the day of service;</text> </paragraph> <paragraph num="(2)"> <text>Submit claims within 180 days of performing the service;</text> </paragraph> <paragraph num="(3)"> <text>Submit claims using the CMS 1500 for paper processing and the HIPAA compliant 837P for electronic processing; and</text> </paragraph> <paragraph num="(4)"> <text>Bill third party insurers before billing the MCO with the exception of well-child care and immunizations.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>More than one visit to complete an EPSDT screen; and</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Program may not make direct payment to participants.</text> </paragraph> <paragraph num="J."> <text>The Program may not make a separate direct payment to any individual employed by or under contract to any SBHC for services provided in an SBHC.</text> </paragraph> <paragraph num="K."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation."> <text>State regulations shall be interpreted in conformity with COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2017 (44:7 Md. R. 355)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective June 14, 2021 (48:12 Md. R. 473); November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04EF amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H—K amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> </annotations> </chapter> <chapter num="77" heading="Urgent Care Centers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(2)"> <text>“Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services.</text> </paragraph> <paragraph num="(3)"> <text>“Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention.</text> </paragraph> <paragraph num="(4)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01.</text> </paragraph> <paragraph num="(5)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(6)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(9)"> <text>“Patient” means a participant awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(10)"> <text>“Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(11)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(12)"> <text>“Provider” means a free-standing urgent care center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a Medical Assistance provider number.</text> </paragraph> <paragraph num="(13)"> <text>“Urgent care” means the delivery of ambulatory care, such as for acute illnesses or minor traumas, in a facility dedicated to the delivery of unscheduled, walk-in care outside of a hospital emergency department, a free-standing clinic, or a physician's office.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>License requirements under this chapter are found in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Urgent care services may be performed only by health care practitioners who are licensed to perform these procedures within the state in which the center is located.</text> </paragraph> <paragraph num="D."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.09.09.02 and 10.10.01.02, as applicable; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>The general requirements for participation in the Program are that a provider shall:</text> <paragraph num="(1)"> <text>Meet all the conditions for participation as set forth in COMAR 10.09.36; and</text> </paragraph> <paragraph num="(2)"> <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The specific requirements for participation in the Program as a free-standing urgent care center include the following:</text> <paragraph num="(1)"> <text>Have clearly defined, written, patient care policies;</text> </paragraph> <paragraph num="(2)"> <text>Define the center's hours of operation and clearly communicate those hours of operation to the public and other relevant organizations;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that patients seeking urgent care are seen without prior appointments;</text> </paragraph> <paragraph num="(4)"> <text>During the hours of operation, have:</text> <paragraph num="(a)"> <text>A supervising physician, available for consultation either in-person or via telehealth; and</text> </paragraph> <paragraph num="(b)"> <text>At least one qualified physician, certified nurse practitioner, or physician assistant present;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintain adequate documentation of each participant visit as part of the individual’s medical record, which, at a minimum, shall include:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>Participant’s reason for visit;</text> </paragraph> <paragraph num="(c)"> <text>A brief description of service provided; and</text> </paragraph> <paragraph num="(d)"> <text>A legible signature and printed or typed name of the professional providing care, with the appropriate title;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; and</text> </paragraph> <paragraph num="(7)"> <text>Have laboratory testing and radiology services available to meet the needs of the patients receiving urgent care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following medically necessary services rendered to participants in a free-standing urgent care center:</text> <paragraph num="A."> <text>Acute illnesses with a sudden onset;</text> </paragraph> <paragraph num="B."> <text>Minor trauma;</text> </paragraph> <paragraph num="C."> <text>Diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative services, when clearly related to the participant’s individual needs;</text> </paragraph> <paragraph num="D."> <text>Urgent care services, when the services are performed by a physician or one of the following acting within the scope of their practice:</text> <paragraph num="(1)"> <text>A licensed physician assistant;</text> </paragraph> <paragraph num="(2)"> <text>A licensed registered nurse; or</text> </paragraph> <paragraph num="(3)"> <text>A certified nurse practitioner; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>Laboratory services as governed by Regulation .02 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="B."> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="C."> <text>Services denied by Medicare as not medically necessary;</text> </paragraph> <paragraph num="D."> <text>Services rendered via telehealth that do not comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department;</text> </paragraph> <paragraph num="E."> <text>Laboratory or x-ray services performed by another facility;</text> </paragraph> <paragraph num="F."> <text>Immunizations, except for:</text> <paragraph num="(1)"> <text>Tetanus; and</text> </paragraph> <paragraph num="(2)"> <text>Rabies;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Visits only to accomplish one or more of the following:</text> <paragraph num="(1)"> <text>Collection of specimens for laboratory procedures;</text> </paragraph> <paragraph num="(2)"> <text>Interpretation of laboratory tests or panels;</text> </paragraph> <paragraph num="(3)"> <text>Ascertaining the patient's weight; and</text> </paragraph> <paragraph num="(4)"> <text>Measurement of blood pressure;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Well child visits; and</text> </paragraph> <paragraph num="I."> <text>Sports physicals</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>Payment for free-standing urgent care centers is as follows:</text> <paragraph num="(1)"> <text>Urgent care centers are reimbursed a facility fee, which is determined by the Program;</text> </paragraph> <paragraph num="(2)"> <text>In addition to the facility fee, the Program shall reimburse for services rendered by the physician, nurse practitioner, or physician assistant during the visit at the free-standing urgent care center; and</text> </paragraph> <paragraph num="(3)"> <text>If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(a)"> <text>The provider:</text> <paragraph num="(i)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be reimbursed in accordance with the provisions of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The provider's reimbursement is not limited to the provider's customary charge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursement by the Program for facility services, which are included in the facility fee, includes:</text> <paragraph num="(1)"> <text>Nursing, technician, and related services;</text> </paragraph> <paragraph num="(2)"> <text>Use of the center;</text> </paragraph> <paragraph num="(3)"> <text>Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the treatment of the illness or injury; and</text> </paragraph> <paragraph num="(4)"> <text>Administrative costs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall pay for covered services at the lesser of:</text> <paragraph num="(1)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department's fee for:</text> <paragraph num="(a)"> <text>Professional services in accordance with COMAR 10.09.02.07D; and</text> </paragraph> <paragraph num="(b)"> <text>Laboratory services in accordance with COMAR 10.09.09.07D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A.</text> </paragraph> <paragraph num="E."> <text>The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed.</text> </paragraph> <paragraph num="F."> <text>The Program shall authorize payment on Medicare claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>Services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall make supplemental payment on Medicare claims subject to the limitations of the State budget and the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance shall be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Beginning with August 1, 2010 dates of service, coinsurance shall be paid:</text> <paragraph num="(a)"> <text>In full for the following:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>CPT codes that are priced by report;</text> </paragraph> <paragraph num="(iii)"> <text>Claims for anesthesia services;</text> </paragraph> <paragraph num="(iv)"> <text>Claims from a federally qualified health center; and</text> </paragraph> <paragraph num="(v)"> <text>HCPCS codes beginning with A through W; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For all other claims, at the lesser of:</text> <paragraph num="(i)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(ii)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare, but considered medically necessary by the Program, will be paid according to the limitations of Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Program may not make a direct payment to a participant.</text> </paragraph> <paragraph num="J."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the participant has insurance, or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C, H amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective July 10. 2023 (50:13 Md. R. 512)</annotation> </annotations> </chapter> <chapter num="78" heading="Home Visiting Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq.</text> </paragraph> <paragraph num="(2)"> <text>“Evidence-based home visiting model” means a voluntary early childhood strategy program that includes focused, individualized, and culturally competent services for expectant parents, young children, and their families designed to enhance parenting and promote the growth and development of young children.</text> </paragraph> <paragraph num="(3)"> <text>“Home” means the program participant’s place of service in a community setting defined by the evidence-based home visiting models.</text> </paragraph> <paragraph num="(4)"> <text>“Home visiting program” means the organization or entity accredited by an evidence-based home visiting model to provide home visiting services under that model.</text> </paragraph> <paragraph num="(5)"> <text>“Home visiting services” means services provided during the prenatal and postpartum periods in the program participant’s home by the home visiting program, including but not limited to:</text> <paragraph num="(a)"> <text>Pregnancy education;</text> </paragraph> <paragraph num="(b)"> <text>Child development education;</text> </paragraph> <paragraph num="(c)"> <text>Diet and nutritional education;</text> </paragraph> <paragraph num="(d)"> <text>Stress management;</text> </paragraph> <paragraph num="(e)"> <text>Sexually transmitted diseases (STD) prevention education;</text> </paragraph> <paragraph num="(f)"> <text>Tobacco use screening and cessation education;</text> </paragraph> <paragraph num="(g)"> <text>Alcohol and other substance misuse screening and counseling;</text> </paragraph> <paragraph num="(h)"> <text>Depression screening;</text> </paragraph> <paragraph num="(i)"> <text>Postpartum depression education;</text> </paragraph> <paragraph num="(j)"> <text>Domestic and intimate partner violence screening and education;</text> </paragraph> <paragraph num="(k)"> <text>Breastfeeding support and education;</text> </paragraph> <paragraph num="(l)"> <text>Guidance and education with regard to well woman visits to obtain recommended preventive services;</text> </paragraph> <paragraph num="(m)"> <text>Maternal-infant safety assessment and education;</text> </paragraph> <paragraph num="(n)"> <text>Counseling regarding postpartum recovery, family planning, and needs of a newborn;</text> </paragraph> <paragraph num="(o)"> <text>Assistance for the family in establishing a primary source of care and a primary care provider;</text> </paragraph> <paragraph num="(p)"> <text>Parenting skills, parent-child relationship building, and confidence building;</text> </paragraph> <paragraph num="(q)"> <text>Child developmental screening at major developmental milestones from birth to two years old;</text> </paragraph> <paragraph num="(r)"> <text>Facilitation of access to community or other resources that can improve birth-related outcomes such as:</text> <paragraph num="(i)"> <text>Transportation;</text> </paragraph> <paragraph num="(ii)"> <text>Housing;</text> </paragraph> <paragraph num="(iii)"> <text>Alcohol, tobacco, and drug cessation; and</text> </paragraph> <paragraph num="(iv)"> <text>WIC, SNAP, and intimate partner violence resources;</text> </paragraph> </paragraph> <paragraph num="(s)"> <text>Monitoring for high blood pressure or other complications of pregnancy; and</text> </paragraph> <paragraph num="(t)"> <text>Medical assessment of the postpartum mother and infant.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Postpartum period” means the period that begins immediately after childbirth up to a period of time following childbirth as defined by the evidence-based home visiting model.</text> </paragraph> <paragraph num="(8)"> <text>“Prenatal period” means the developmental period between conception and birth.</text> </paragraph> <paragraph num="(9)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(10)"> <text>“Program participant” means one of the following individuals enrolled in the evidence-based home visiting model:</text> <paragraph num="(a)"> <text>Birthing parent;</text> </paragraph> <paragraph num="(b)"> <text>Infant;</text> </paragraph> <paragraph num="(c)"> <text>Child up to the age permitted under the evidence-based home visiting model; or</text> </paragraph> <paragraph num="(d)"> <text>Other individuals, as recognized under the evidence-based home visiting model.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Provider” means a qualified individual licensed or certified to deliver home visiting services as a part of an evidence-based home visiting model.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification Requirements."> <text>The home visiting program provider shall have an active accreditation status from one of the following evidence-based home visiting models:</text> <paragraph num="A."> <text>Healthy Families America (HFA); or</text> </paragraph> <paragraph num="B."> <text>Nurse Family Partnership (NFP).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the home visiting program are that the provider shall provide proof of accreditation by one of the following evidence-based home visiting models:</text> <paragraph num="(1)"> <text>Healthy Families America (HFA); or</text> </paragraph> <paragraph num="(2)"> <text>Nurse Family Partnership (NFP).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers home visiting services rendered in the program participant’s home when the services:</text> <paragraph num="A."> <text>Are rendered during the birthing parent’s prenatal period and postpartum periods; and</text> </paragraph> <paragraph num="B."> <text>If not rendered in person, comply with the telehealth requirements established in COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover:</text> <paragraph num="A."> <text>Expenses including:</text> <paragraph num="(1)"> <text>Administrative overhead;</text> </paragraph> <paragraph num="(2)"> <text>Lactation consulting services; and</text> </paragraph> <paragraph num="(3)"> <text>Program start-up costs for evidence-based model accreditation, initial training, or consultation; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services that are not medically necessary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment in the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program.</text> </paragraph> <paragraph num="C."> <text>The provider shall charge the Program the provider’s customary charge to the general public for similar services.</text> </paragraph> <paragraph num="D."> <text>The Program will reimburse a provider for covered services:</text> <paragraph num="(1)"> <text>The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>In accordance with §I of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the service is free to individuals not covered by Medicaid:</text> <paragraph num="(1)"> <text>The provider:</text> <paragraph num="(a)"> <text>May charge the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be reimbursed in accordance with §I of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The provider may not bill the Program or the participant for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail; or</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Payments for services rendered to a Program participant shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="I."> <text>Effective January 1, 2022, the Program shall reimburse a flat rate of $188 per home visit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 13, 2022 (49:1 Md. R. 13)</annotation> </annotations> </chapter> <chapter num="79" heading="Presumptive Eligibility for Correctional Facilities"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter establishes requirements for qualified State and local corrections facilities to make presumptive eligibility determinations effective July 1, 2017.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has applied for presumptive eligibility at a participating qualified correctional facility.</text> </paragraph> <paragraph num="(2)"> <text>“Application” means the presumptive eligibility application.</text> </paragraph> <paragraph num="(3)"> <text>“Correctional facility” has the meaning stated in Correctional Services Article, §1-101, Annotated Code of Maryland, and includes:</text> <paragraph num="(a)"> <text>Correctional facilities under the direction of the Department of Public Safety and Correctional Services; and</text> </paragraph> <paragraph num="(b)"> <text>Local correctional facilities within the State’s 24 local jurisdictions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Determination” means a decision regarding an applicant’s presumptive eligibility.</text> </paragraph> <paragraph num="(6)"> <text>“Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2).</text> </paragraph> <paragraph num="(7)"> <text>“Former foster care” means an individual who:</text> <paragraph num="(a)"> <text>Is younger than 26 years old;</text> </paragraph> <paragraph num="(b)"> <text>Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and</text> </paragraph> <paragraph num="(c)"> <text>Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance:</text> <paragraph num="(i)"> <text>On attaining age 18 and leaving out-of-home placement; or</text> </paragraph> <paragraph num="(ii)"> <text>On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Incarcerated inmate” means an individual who resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status.</text> </paragraph> <paragraph num="(9)"> <text>“Income” means property or a service received by an individual in cash or in-kind that can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals.</text> </paragraph> <paragraph num="(11)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Memorandum of understanding” means the agreement by which the correctional facility has contracted with the Department and been deemed a qualified entity eligible to make presumptive eligibility decisions.</text> </paragraph> <paragraph num="(13)"> <text>“Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by an eligibility worker at a participating qualified correctional facility in accordance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements."> <paragraph num="A."> <text>A correctional facility based in Maryland is eligible to participate as a presumptive eligibility entity.</text> </paragraph> <paragraph num="B."> <text>The eligibility worker shall:</text> <paragraph num="(1)"> <text>Using the Department’s eligibility verification system, verify the individual is not actively enrolled in the Maryland Medical Assistance Program; and</text> </paragraph> <paragraph num="(2)"> <text>Complete the full Medical Assistance application process;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless the individual is enrolled in the Maryland Medical Assistance Program, the eligibility worker shall:</text> <paragraph num="(1)"> <text>Fill out the presumptive eligibility application based on information supplied by the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Make a presumptive eligibility determination based on the following information:</text> <paragraph num="(a)"> <text>Residency;</text> </paragraph> <paragraph num="(b)"> <text>Citizenship;</text> </paragraph> <paragraph num="(c)"> <text>Family size and composition; and</text> </paragraph> <paragraph num="(d)"> <text>Gross family income;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Sign the application; and</text> </paragraph> <paragraph num="(4)"> <text>Inform the applicant in writing of the presumptive eligibility determination, which includes an explanation of the presumptive eligibility coverage span.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In order to ensure the applicant has temporary Medical Assistance coverage, the eligibility worker shall submit the presumptive eligibility application to the Department on the date the application is completed.</text> </paragraph> <paragraph num="E."> <text>After the application has been submitted, the correctional facility shall:</text> <paragraph num="(1)"> <text>Keep all written and signed presumptive eligibility applications on file for 6 years; and</text> </paragraph> <paragraph num="(2)"> <text>Make the file available to the Department on request.</text> </paragraph> </paragraph> <paragraph num="F."> <text>On finding that a qualified correctional facility has failed to meet the requirements of §§A—E of this regulation, the facility shall take reasonable corrective action measures, as determined by the Department, to address the noncompliance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Presumptive Eligibility Criteria."> <paragraph num="A."> <text>An individual shall apply for presumptive eligibility through a participating correctional facility.</text> </paragraph> <paragraph num="B."> <text>An individual who applies for presumptive eligibility shall attest to:</text> <paragraph num="(1)"> <text>The citizenship requirements in COMAR 10.09.24.05;</text> </paragraph> <paragraph num="(2)"> <text>The residency requirements in COMAR 10.09.24.05-3;</text> </paragraph> <paragraph num="(3)"> <text>The individual’s pregnancy status;</text> </paragraph> <paragraph num="(4)"> <text>The individual’s family size; and</text> </paragraph> <paragraph num="(5)"> <text>The individual’s household’s gross monthly income.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligible Populations."> <text>If an incarcerated inmate in a Maryland-based correctional facility is determined to be eligible for one of the following coverage groups, the individual may qualify for presumptive eligibility for correctional facilities:</text> <paragraph num="A."> <text>Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level;</text> </paragraph> <paragraph num="B."> <text>Pregnant women whose income is equal to or less than 250 percent of the federal poverty level;</text> </paragraph> <paragraph num="C."> <text>Childless adults 19 years old or older and younger than 65 years old whose household income is equal to or less than 133 percent of the federal poverty level; and</text> </paragraph> <paragraph num="D."> <text>Former foster care individuals who are younger than 26 years old.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <text>Presumptive eligibility may not be granted to an individual who:</text> <paragraph num="A."> <text>Is currently enrolled in the Maryland Medical Assistance Program or Medicare;</text> </paragraph> <paragraph num="B."> <text>With the exception of pregnant women, had a prior presumptive eligibility period during the last 12 months;</text> </paragraph> <paragraph num="C."> <text>Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or</text> </paragraph> <paragraph num="D."> <text>Does not meet the citizenship requirements stated in COMAR 10.09.24.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Coverage Span."> <paragraph num="A."> <text>Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible.</text> </paragraph> <paragraph num="B."> <text>Presumptive eligibility ends on the earlier of:</text> <paragraph num="(1)"> <text>The day the individual is determined eligible for Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>The last day of the month following the month in which the correctional facility determined presumptive eligibility, if an individual:</text> <paragraph num="(a)"> <text>Is found ineligible for Medical Assistance; or</text> </paragraph> <paragraph num="(b)"> <text>Failed to apply for Medical Assistance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A non-pregnant individual may be determined presumptively eligible once per a 12-month period.</text> </paragraph> <paragraph num="D."> <text>A pregnant individual may be determined presumptively eligible once per pregnancy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Presumptive Eligibility Appeal Rights."> <text>An individual or an organization does not have appeal rights for presumptive eligibility determinations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-103(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 18, 2017 (44:25 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 30, 2019 (46:26 Md. R. 1164); March 30, 2026 (53:6 Md. R. 291)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 30, 2019 (46:26 Md. R. 1164)</annotation> </annotations> </chapter> <chapter num="80" heading="Community-Based Substance Use Disorder Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative Service Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System.</text> </paragraph> <paragraph num="(2)"> <text>“Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department.</text> </paragraph> <paragraph num="(3)"> <text>“Community-based substance use disorder program” means a program that provides services in community settings not regulated by the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="(4)"> <text>“DATA 2000 waived provider” means a provider who has received a waiver under the Drug Addiction and Treatment Act of 2000 which expands the clinical context of medication assisted opioid dependency treatment and permits qualified physicians, nurse practitioners, and physician assistants to dispense or prescribe certain narcotic medications that have a lower risk of abuse, like buprenorphine, in settings other than an opioid treatment program.</text> </paragraph> <paragraph num="(5)"> <text>“DEA” means the Drug Enforcement Administration of the U.S. Department of Justice.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(7)"> <text>“Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment.</text> </paragraph> <paragraph num="(8)"> <text>“Documentation” means the written medical record.</text> </paragraph> <paragraph num="(9)"> <text>“Individualized treatment plan” means a written plan of action that is developed and periodically updated and revised to address a participant’s specific service needs.</text> </paragraph> <paragraph num="(10)"> <text>“License” means the approval issued to a program by the BHA or its designee that permits a behavioral health provider to operate in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(12)"> <text>“Medically necessary” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(13)"> <text>“Medication management” means a visit with a physician, nurse practitioner, or physician assistant for the purpose of evaluation, prescribing, and providing medications for substance use disorder symptom reduction, withdrawal management, or medication assisted treatment.</text> </paragraph> <paragraph num="(14)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(15)"> <text>“Peer recovery support services” means a set of nonclinical activities provided by individuals in recovery from behavioral health concerns, including substance use or addictive disorders or mental health concerns, who use their personal, lived experiences and training to support other individuals with substance use or addictive disorders.</text> </paragraph> <paragraph num="(16)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(17)"> <text>“Progress note” means an objective documentation of the participant’s progress in relation to specific treatment goals and objectives.</text> </paragraph> <paragraph num="(18)"> <text>“Recovery support services” means community-based services provided to people and their families during the initiation, on-going, and post-acute stages of their recovery from substance abuse.</text> </paragraph> <paragraph num="(19)"> <text>“Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.</text> </paragraph> <paragraph num="(20)"> <text>“Substance use disorder services” means the services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Telehealth” has the meaning stated in COMAR 10.09.49.02.</text> </paragraph> <paragraph num="(22)"> <text>“Treatment plan” means a written plan that addresses the individual’s biopsychosocial needs through goals and objectives and is updated as needed according to the treatment modality.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02 and 10.63.01.03.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Provider Participation."> <paragraph num="A."> <text>A provider shall be in compliance with COMAR 10.09.36.03 and 10.63.01.05.</text> </paragraph> <paragraph num="B."> <text>A provider of community-based substance use disorder services shall include:</text> <paragraph num="(1)"> <text>Community-based substance use disorder providers that:</text> <paragraph num="(a)"> <text>Are licensed by the Department as community-based substance use disorder providers pursuant to the requirements listed in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Maintain verification of licenses and credentials of all professionals employed by or under contract with the provider in their respective personnel files; and</text> </paragraph> <paragraph num="(c)"> <text>Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Federally qualified health centers in compliance with COMAR 10.09.08; or</text> </paragraph> <paragraph num="(3)"> <text>Opioid treatment programs that:</text> <paragraph num="(a)"> <text>Are licensed by the Department’s Behavioral Health Administration;</text> </paragraph> <paragraph num="(b)"> <text>Are approved by the U.S. Drug Enforcement Administration; and</text> </paragraph> <paragraph num="(c)"> <text>Comply with 42 CFR Part 8.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider of substance use disorder services shall maintain adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, includes:</text> <paragraph num="(1)"> <text>The date of service with start and end times;</text> </paragraph> <paragraph num="(2)"> <text>Documents all services received by the participant;</text> </paragraph> <paragraph num="(3)"> <text>The participant’s primary reason for the substance use disorder visit;</text> </paragraph> <paragraph num="(4)"> <text>A description of the service provided;</text> </paragraph> <paragraph num="(5)"> <text>Progress notes; and</text> </paragraph> <paragraph num="(6)"> <text>An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The providers shall make the documentation required under Regulation .05C available, as requested to carry out required activities, to:</text> <paragraph num="(1)"> <text>The Department;</text> </paragraph> <paragraph num="(2)"> <text>The ASO;</text> </paragraph> <paragraph num="(3)"> <text>The Core Service Agency;</text> </paragraph> <paragraph num="(4)"> <text>The Local Addictions Authority;</text> </paragraph> <paragraph num="(5)"> <text>The Local Behavioral Health Authority;</text> </paragraph> <paragraph num="(6)"> <text>The Office of Inspector General of the Department; and</text> </paragraph> <paragraph num="(7)"> <text>The Office of the Attorney General Medicaid Fraud Control Unit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A provider shall comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.</text> </paragraph> <paragraph num="F."> <text>If delivering services via telehealth, a provider shall comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participant Eligibility and Referral."> <paragraph num="A."> <text>A participant may self-refer or be referred to substance use disorder treatment by a:</text> <paragraph num="(1)"> <text>Provider;</text> </paragraph> <paragraph num="(2)"> <text>Family member;</text> </paragraph> <paragraph num="(3)"> <text>Caregiver; or</text> </paragraph> <paragraph num="(4)"> <text>Local health authority.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual is eligible for substance use disorder services if:</text> <paragraph num="(1)"> <text>The individual meets the Department’s medical necessity criteria; and</text> </paragraph> <paragraph num="(2)"> <text>The service is appropriate to the specific provider type or community-based substance use disorder providers listed in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>Comprehensive substance use disorder assessment at a minimum shall:</text> <paragraph num="(1)"> <text>Be delivered through:</text> <paragraph num="(a)"> <text>A BHA licensed substance use disorder treatment provider; or</text> </paragraph> <paragraph num="(b)"> <text>An opioid treatment program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be completed before providing the community based behavioral health services listed in §§BI of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and</text> </paragraph> <paragraph num="(4)"> <text>Include:</text> <paragraph num="(a)"> <text>An assessment of the following areas:</text> <paragraph num="(i)"> <text>Drug and alcohol use; and</text> </paragraph> <paragraph num="(ii)"> <text>Substance use disorder treatment history;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Referrals for physical and mental health services; and</text> </paragraph> <paragraph num="(c)"> <text>Recommendation for the appropriate level of substance use disorder treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Peer recovery support services shall:</text> <paragraph num="(1)"> <text>Be included as part of a written individualized treatment plan that includes specific individualized goals;</text> </paragraph> <paragraph num="(2)"> <text>Be delivered through a BHA licensed:</text> <paragraph num="(a)"> <text>Outpatient substance use disorder treatment provider in compliance with COMAR 10.63.03.06, 10.63.03.03 or 10.63.03.07; or</text> </paragraph> <paragraph num="(b)"> <text>Opioid treatment program in compliance with COMAR 10.63.03.19;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be provided by staff who, at a minimum:</text> <paragraph num="(a)"> <text>Maintains active certification by BHA or its designee;</text> </paragraph> <paragraph num="(b)"> <text>Self-identifies as an individual with life experience of being diagnosed with behavioral health concerns, including substance use disorders, addictive disorders, or mental health concerns;</text> </paragraph> <paragraph num="(c)"> <text>Completes ongoing training as approved by BHA or its designee; and</text> </paragraph> <paragraph num="(d)"> <text>Receives supervision by:</text> <paragraph num="(i)"> <text>A registered peer supervisor approved by BHA or its designee; or</text> </paragraph> <paragraph num="(ii)"> <text>An individual practitioner as defined in COMAR 10.09.59.04A(2) or a certified alcohol and drug counselor who is approved to supervise by the relevant board and who must be an approved registered peer supervisor on or after September 1, 2023; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be provided directly to the participant either in-person or via telehealth.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Level 1 group and individual substance use disorder counseling shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.06;</text> </paragraph> <paragraph num="(2)"> <text>Be delivered through:</text> <paragraph num="(a)"> <text>A BHA licensed substance use disorder treatment provider; or</text> </paragraph> <paragraph num="(b)"> <text>An opioid treatment program;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include services for participants who require less than 9 hours weekly for adults and 6 hours weekly for adolescents;</text> </paragraph> <paragraph num="(4)"> <text>Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall:</text> <paragraph num="(a)"> <text>Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and</text> </paragraph> <paragraph num="(b)"> <text>Include:</text> <paragraph num="(i)"> <text>Participant treatment plan goals;</text> </paragraph> <paragraph num="(ii)"> <text>Referrals to ancillary services, if needed; and</text> </paragraph> <paragraph num="(iii)"> <text>Referral to recovery support services, if needed; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Include family members, if necessary, as long as the participant is also present in a Level 1 group counseling session.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Level 2.1 Intensive Outpatient services shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.03;</text> </paragraph> <paragraph num="(2)"> <text>Be delivered through a BHA licensed substance use disorder treatment provider only;</text> </paragraph> <paragraph num="(3)"> <text>Include services for participants who require outpatient treatment for 9 or more hours weekly for an adult and 6 or more hours weekly for an adolescent;</text> </paragraph> <paragraph num="(4)"> <text>Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall:</text> <paragraph num="(a)"> <text>Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and</text> </paragraph> <paragraph num="(b)"> <text>Include:</text> <paragraph num="(i)"> <text>Participant treatment plan goals; and</text> </paragraph> <paragraph num="(ii)"> <text>Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Level 2.5 partial hospitalization services shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.07;</text> </paragraph> <paragraph num="(2)"> <text>Be delivered through a BHA licensed substance use disorder treatment provider;</text> </paragraph> <paragraph num="(3)"> <text>Include services for participants who require a minimum of 20 hours weekly of structured outpatient treatment delivered in the following ways:</text> <paragraph num="(a)"> <text>Half day sessions with a minimum of 2 hours per day of services; or</text> </paragraph> <paragraph num="(b)"> <text>Full day sessions with a minimum of 6 hours per day of services;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall:</text> <paragraph num="(a)"> <text>Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and</text> </paragraph> <paragraph num="(b)"> <text>Include:</text> <paragraph num="(i)"> <text>Participant treatment plan goals; and</text> </paragraph> <paragraph num="(ii)"> <text>Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Ambulatory withdrawal management service shall:</text> <paragraph num="(1)"> <text>Comply with COMAR 10.63.03.18;</text> </paragraph> <paragraph num="(2)"> <text>Be delivered through a BHA licensed substance use disorder treatment provider;</text> </paragraph> <paragraph num="(3)"> <text>Include the following services as medically necessary:</text> <paragraph num="(a)"> <text>Administration and monitoring of medication, including administration and monitoring of psychotropic medication by qualified staff, as necessary; and</text> </paragraph> <paragraph num="(b)"> <text>Managing withdrawal symptoms; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Include a participant progress note added to the participant-s record after each session.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Buprenorphine and other medication assisted treatment delivered by a BHA licensed substance use disorder treatment provider that employs a practitioner who holds a DEA registration with Schedule III authority in compliance with 21 U.S.C. §823 shall include the following:</text> <paragraph num="(1)"> <text>Services delivered by a DEA registered practitioner with Schedule III authority, including:</text> <paragraph num="(a)"> <text>Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants;</text> </paragraph> <paragraph num="(b)"> <text>At a minimum, medical services required to be provided by the Program that:</text> <paragraph num="(i)"> <text>Ensure that participants receive a dose adequate to alleviate withdrawal symptoms;</text> </paragraph> <paragraph num="(ii)"> <text>Employ dose increases and behavior therapy before mandatory detoxification for participants continuing to use drugs;</text> </paragraph> <paragraph num="(iii)"> <text>Establish participant dosing based on an individual need;</text> </paragraph> <paragraph num="(iv)"> <text>Provide flexible dosage tapering and withdrawal management with dosage reductions at the participant’s request;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Ordering and administering non-narcotic drugs; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services provided by alcohol and drug counselors and other staff as appropriate, including:</text> <paragraph num="(a)"> <text>Substance use disorder and related counseling as recommended in the individualized treatment plan; and</text> </paragraph> <paragraph num="(b)"> <text>Point of care presumptive drug testing that shall be:</text> <paragraph num="(i)"> <text>Presumptive in nature and performed at the point of care; and</text> </paragraph> <paragraph num="(ii)"> <text>Capable of being read by direct optical observation only.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>For dates of service before January 1, 2023, BHA licensed substance use disorder treatment providers rendering buprenorphine and other medication assisted treatment are required to comply with requirements for DATA 2000 waived providers.</text> </paragraph> <paragraph num="I."> <text>Opioid maintenance therapy services delivered through the use of methadone or buprenorphine by opioid treatment programs shall comply with 10.63.03.19 and include:</text> <paragraph num="(1)"> <text>An individualized treatment plan that shall be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law;</text> </paragraph> <paragraph num="(2)"> <text>The following services:</text> <paragraph num="(a)"> <text>Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants;</text> </paragraph> <paragraph num="(b)"> <text>Point of care presumptive drug testing;</text> </paragraph> <paragraph num="(c)"> <text>Definitive drug testing when completed by a laboratory;</text> </paragraph> <paragraph num="(d)"> <text>Substance use disorder and related counseling as recommended in the individualized treatment plan;</text> </paragraph> <paragraph num="(e)"> <text>Periodic medication management;</text> </paragraph> <paragraph num="(f)"> <text>Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and</text> </paragraph> <paragraph num="(g)"> <text>Ordering and administering non-narcotic drugs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services; and</text> </paragraph> <paragraph num="(4)"> <text>Guest dosing arrangements with other opioid treatment programs, as medically necessary.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Medication assisted treatment induction service delivered by opioid treatment programs shall include the following services, as medically necessary:</text> <paragraph num="(1)"> <text>Pharmacological interventions, including the use of one of the following FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants:</text> <paragraph num="(a)"> <text>Buprenorphine; or</text> </paragraph> <paragraph num="(b)"> <text>Methadone;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and</text> </paragraph> <paragraph num="(3)"> <text>Ordering and administering non-narcotic drugs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <paragraph num="A."> <text>The Program under this chapter does not cover the following:</text> <paragraph num="(1)"> <text>Community-based substance use disorder services not specified in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Community-based substance use disorder services not approved by a licensed physician or other licensed practitioner of the healing arts, within the scope of his or her practice under State law;</text> </paragraph> <paragraph num="(3)"> <text>Services not identified by the Department as medically necessary or listed in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Investigational and experimental drugs and procedures;</text> </paragraph> <paragraph num="(5)"> <text>Substance use disorder visits solely for the purpose of:</text> <paragraph num="(a)"> <text>Prescribing medication;</text> </paragraph> <paragraph num="(b)"> <text>Administering medication;</text> </paragraph> <paragraph num="(c)"> <text>Drug or supply pick-up;</text> </paragraph> <paragraph num="(d)"> <text>Collecting laboratory specimens;</text> </paragraph> <paragraph num="(e)"> <text>Interpreting laboratory tests or panels; or</text> </paragraph> <paragraph num="(f)"> <text>Administering injections, unless the following are documented in the participant’s medical record:</text> <paragraph num="(i)"> <text>Medical necessity; and</text> </paragraph> <paragraph num="(ii)"> <text>The participant’s inability to take appropriate oral medications;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Services that are provided in a hospital inpatient or outpatient setting or in an intermediate care facility for behavioral health;</text> </paragraph> <paragraph num="(7)"> <text>Services beyond the provider’s scope of practice;</text> </paragraph> <paragraph num="(8)"> <text>Services that are separately billed but included as part of another service;</text> </paragraph> <paragraph num="(9)"> <text>Buprenorphine induction and buprenorphine maintenance therapy services that are:</text> <paragraph num="(a)"> <text>Delivered by a participant’s primary care provider which are the responsibility of the Managed Care Organization as specified in COMAR 10.67.08; or</text> </paragraph> <paragraph num="(b)"> <text>Delivered without a primary diagnosis of substance use disorder;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Presumptive and definitive drug testing when billed by:</text> <paragraph num="(a)"> <text>An opioid treatment program;</text> </paragraph> <paragraph num="(b)"> <text>An intensive outpatient program; or</text> </paragraph> <paragraph num="(c)"> <text>A partial hospitalization program provider; (</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Peer recovery support services that are not provided either in-person or via telehealth; and</text> </paragraph> <paragraph num="(12)"> <text>Services not authorized consistent with this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Providers may not be reimbursed by the Program for:</text> <paragraph num="(1)"> <text>More than one comprehensive substance use disorder assessment for a participant per provider per 12-month period unless there is a break in treatment over 30 calendar days;</text> </paragraph> <paragraph num="(2)"> <text>More than one Level 1 group counseling session per day per participant;</text> </paragraph> <paragraph num="(3)"> <text>More than six Level 1 individual counseling units as measured in 15 minute increments per day per participant;</text> </paragraph> <paragraph num="(4)"> <text>More than four sessions of Level 2.1 Intensive Outpatient treatment per week;</text> </paragraph> <paragraph num="(5)"> <text>Level 1 group or individual counseling during the same week as a Level 2.1 Intensive Outpatient treatment or Level 2.5 Partial Hospitalization service unless the participant has been discharged from or admitted to a new level of care;</text> </paragraph> <paragraph num="(6)"> <text>Overlapping episodes of Level 2.1 Intensive Outpatient treatment and Level 2.5 Partial Hospitalization;</text> </paragraph> <paragraph num="(7)"> <text>Level 1 group or individual counseling during the same week as Level 1 group or individual counseling offered by another provider;</text> </paragraph> <paragraph num="(8)"> <text>Psychiatric day treatment service as described in COMAR [10.09.02.01] 10.63.03.08 or an intensive outpatient mental health service on the same day as a Level 2.1 Intensive Outpatient program or Level 2.5 Partial Hospitalization program</text> </paragraph> <paragraph num="(9)"> <text>Buprenorphine maintenance therapy delivered by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same week as Methadone Maintenance Therapy;</text> </paragraph> <paragraph num="(10)"> <text>Ambulatory withdrawal management during the same week as an opioid maintenance therapy, medication assisted treatment induction, or buprenorphine maintenance service;</text> </paragraph> <paragraph num="(11)"> <text>Medication management billed by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same days as medication assisted treatment induction;</text> </paragraph> <paragraph num="(12)"> <text>Community-based substance use disorder services on the same day that a participant received similar services as a hospital inpatient or outpatient;</text> </paragraph> <paragraph num="(13)"> <text>Services delivered by federally qualified health centers other than those billed using T-codes that may include the following delivered by two separate appropriately licensed providers:</text> <paragraph num="(a)"> <text>One T-code for mental health services per day with associated mental health procedure code; and</text> </paragraph> <paragraph num="(b)"> <text>One T-code for substance use disorder services with associated H-code per day;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Services rendered but not appropriately documented to the level of service;</text> </paragraph> <paragraph num="(15)"> <text>Services rendered by mail;</text> </paragraph> <paragraph num="(16)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(17)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(18)"> <text>Travel to and from site of service; and</text> </paragraph> <paragraph num="(19)"> <text>Transportation costs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In order to bill for an individual in Level 2.1 Intensive Outpatient treatment, the per diem session shall include a minimum of 2 hours. A maximum of 4 per diems may be billed per week.</text> </paragraph> <paragraph num="D."> <text>In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a half day session shall include a minimum of 2 hours.</text> </paragraph> <paragraph num="E."> <text>In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a full day session shall include a minimum of 6 hours.</text> </paragraph> <paragraph num="F."> <text>The Department shall pay participating opioid treatment programs, per participant, per week provided the participant received ongoing opioid treatment medications and at least one face-to-face documented treatment service in the month for which the Program is billed.</text> </paragraph> <paragraph num="G."> <text>In order for an opioid treatment program to bill for medication assisted treatment induction, the provider shall bill this service only in the first week of treatment per participant or in the first week of treatment after a break from treatment of at least 6 months.</text> </paragraph> <paragraph num="H."> <text>In order for an opioid treatment program to bill for buprenorphine maintenance therapy, the provider shall bill this service per participant per week.</text> </paragraph> <paragraph num="I."> <text>In order to bill for ambulatory withdrawal management, providers may bill up to 5 per diems during the detoxification episode if determined medically necessary by the Department.</text> </paragraph> <paragraph num="J."> <text>Peer recovery support services may not be used to supplant the minimum billing requirements for:</text> <paragraph num="(1)"> <text>Level 2.1 Intensive Outpatient treatment as described in §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Level 2.5 Partial Hospitalization half day session as described in §D of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Level 2.5 Partial Hospitalization full day session as described in §E of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Opioid treatment program services as described in §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="K."> <text>All drug screening lab claims submitted to the ASO by providers other than opioid treatment programs shall list the applicable substance use disorder diagnosis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Authorization Requirements."> <paragraph num="A."> <text>For services outlined in Regulation .05 of this chapter, the community-based substance use disorder program shall notify the ASO and obtain authorization to provide substance use disorder services from the ASO.</text> </paragraph> <paragraph num="B."> <text>The ASO agent shall authorize services that are:</text> <paragraph num="(1)"> <text>Medically necessary; and</text> </paragraph> <paragraph num="(2)"> <text>Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness.</text> </paragraph> </paragraph> <paragraph num="C."> <text>No payment shall be rendered for services that have not been authorized by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment Procedures."> <paragraph num="A."> <text>General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Unless the care is free to other patients, a provider shall bill the Program their usual and customary charge to the general public.</text> </paragraph> <paragraph num="D."> <text>For dates of service July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For services outlined in this regulation, as delivered through a BHA licensed substance use disorder treatment provider:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $198.35;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $54.49 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Level 2.1 Intensive Outpatient treatment — $174.60 per diem;</text> </paragraph> <paragraph num="(e)"> <text>Level 2.5 Partial Hospitalization half day session — $181.58 per diem;</text> </paragraph> <paragraph num="(f)"> <text>Level 2.5 Partial Hospitalization full day session — $293.31 per diem;</text> </paragraph> <paragraph num="(g)"> <text>Ambulatory Withdrawal Management —$97.78 per diem;</text> </paragraph> <paragraph num="(h)"> <text>Individual peer support services — $16.87 per 15-minute increment;</text> </paragraph> <paragraph num="(i)"> <text>Group peer support services — $4.69 per 15-minute increment;</text> </paragraph> <paragraph num="(j)"> <text>Point of care presumptive drug test read with direct optical observation only — $10.02 per test;</text> </paragraph> <paragraph num="(k)"> <text>Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test;</text> </paragraph> <paragraph num="(l)"> <text>Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and</text> </paragraph> <paragraph num="(m)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For services outlined in this regulation as delivered through an opioid treatment program:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $198.35;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $54.49 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Opioid Maintenance Therapy — $86.27 per participant per week;</text> </paragraph> <paragraph num="(e)"> <text>Medication Assisted Treatment Induction — $279.36 per participant per week;</text> </paragraph> <paragraph num="(f)"> <text>Buprenorphine Maintenance Therapy — $76.69 per participant per week;</text> </paragraph> <paragraph num="(g)"> <text>Individual peer support services — $16.87 per 15-minute increment;</text> </paragraph> <paragraph num="(h)"> <text>Group peer support services — $4.69 per 15-minute increment; and</text> </paragraph> <paragraph num="(i)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>For dates of service January 1, 2024, through June 30, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $214.22;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $58.85 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Level 2.1 Intensive Outpatient treatment — $188.57 per diem;</text> </paragraph> <paragraph num="(e)"> <text>Level 2.5 Partial Hospitalization half day session — $196.11 per diem;</text> </paragraph> <paragraph num="(f)"> <text>Level 2.5 Partial Hospitalization full day session — $316.77 per diem;</text> </paragraph> <paragraph num="(g)"> <text>Ambulatory Withdrawal Management —$105.60 per diem;</text> </paragraph> <paragraph num="(h)"> <text>Individual peer support services — $18.22 per 15-minute increment;</text> </paragraph> <paragraph num="(i)"> <text>Group peer support services — $5.07 per 15-minute increment;</text> </paragraph> <paragraph num="(j)"> <text>Point of care presumptive drug test read with direct optical observation only — $10.02 per test;</text> </paragraph> <paragraph num="(k)"> <text>Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test;</text> </paragraph> <paragraph num="(l)"> <text>Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and</text> </paragraph> <paragraph num="(m)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For services outlined in this chapter as delivered through an opioid treatment program:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $214.22;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $58.85 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Opioid Maintenance Therapy — $93.17 per participant per week;</text> </paragraph> <paragraph num="(e)"> <text>Medication Assisted Treatment Induction — $301.71 per participant per week;</text> </paragraph> <paragraph num="(f)"> <text>Buprenorphine Maintenance Therapy — $82.83 per participant per week;</text> </paragraph> <paragraph num="(g)"> <text>Individual peer support services — $18.22 per 15-minute increment;</text> </paragraph> <paragraph num="(h)"> <text>Group peer support services — $5.07 per 15-minute increment; and</text> </paragraph> <paragraph num="(i)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Effective July 1, 2024, rates for the services outlined in this chapter shall be as follows:</text> <paragraph num="(1)"> <text>For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $220.65;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $60.62 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Level 2.1 Intensive Outpatient treatment — $194.23 per diem;</text> </paragraph> <paragraph num="(e)"> <text>Level 2.5 Partial Hospitalization half day session — $201.99 per diem;</text> </paragraph> <paragraph num="(f)"> <text>Level 2.5 Partial Hospitalization full day session — $326.27 per diem;</text> </paragraph> <paragraph num="(g)"> <text>Ambulatory Withdrawal Management —$108.77 per diem;</text> </paragraph> <paragraph num="(h)"> <text>Individual peer support services — $18.77 per 15-minute increment;</text> </paragraph> <paragraph num="(i)"> <text>Group peer support services — $5.22 per 15-minute increment;</text> </paragraph> <paragraph num="(j)"> <text>Point of care presumptive drug test read with direct optical observation only — $10.02 per test;</text> </paragraph> <paragraph num="(k)"> <text>Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test;</text> </paragraph> <paragraph num="(l)"> <text>Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and</text> </paragraph> <paragraph num="(m)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For services outlined in this chapter as delivered through an opioid treatment program:</text> <paragraph num="(a)"> <text>Comprehensive substance use disorder assessment — $220.65;</text> </paragraph> <paragraph num="(b)"> <text>Level 1 group substance use disorder counseling — $60.62 per session;</text> </paragraph> <paragraph num="(c)"> <text>Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day;</text> </paragraph> <paragraph num="(d)"> <text>Opioid Maintenance Therapy — $95.97 per participant per week;</text> </paragraph> <paragraph num="(e)"> <text>Medication Assisted Treatment Induction — $310.76 per participant per week;</text> </paragraph> <paragraph num="(f)"> <text>Buprenorphine Maintenance Therapy — $85.31 per participant per week;</text> </paragraph> <paragraph num="(g)"> <text>Individual peer support services — $18.77 per 15-minute increment;</text> </paragraph> <paragraph num="(h)"> <text>Group peer support services — $5.22 per 15-minute increment; and</text> </paragraph> <paragraph num="(i)"> <text>Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Program shall make no direct payment to participants.</text> </paragraph> <paragraph num="H."> <text>The Department shall authorize supplemental payment on Medicare claims only if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Department shall make payment on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and</text> </paragraph> <paragraph num="(2)"> <text>The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </paragraph> <paragraph num="B."> <text>The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall:</text> <paragraph num="(1)"> <text>Establish the:</text> <paragraph num="(a)"> <text>Effective date of the proposed action; and</text> </paragraph> <paragraph num="(b)"> <text>Reasons for the proposed action; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Advise the provider of the right to appeal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Appeal Procedures."> <text>Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Interpretive Regulation."> <text>This chapter shall be interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c)(1),15-103(a)(1), and 15-105(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); adopted permanently effective May 31, 2010 (37:11 Md. R. 765)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 22, 2014 (41:25 Md. R. 1480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1302); September 25, 2017 (44:19 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective September 25, 2017 (44:19 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1302)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); September 25, 2017 (44:19 Md. R. 897); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); May 15, 2023 (50:9 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective November 14, 2022 (49:23 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective October 26, 2015 (42:21 Md. R. 1302)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective October 24, 2016 (43:21 Md. R. 1166); April 10, 2017 (44:7 Md. R. 356); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D – F amended August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> <chapter num="81" heading="Increased Community Services (ICS) Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of the Increased Community Services (ICS) Program is to enable certain nursing facility residents to access home and community-based services by allowing those nursing facility residents to contribute to the cost of care through a monthly assessment and thus enabling those individuals to live at home with ICS and other Medicaid services instead of in a nursing facility.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means bathing, eating, toileting, dressing, and mobility including transfer.</text> </paragraph> <paragraph num="(2)"> <text>“Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with this chapter and COMAR 10.09.30, evaluates ICS applicants and participants.</text> </paragraph> <paragraph num="(3)"> <text>“Agency-employed attendant” means an attendant who is employed by, or under contract with, an attendant care provider agency.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means an individual who has submitted to the Department an application for the ICS Program.</text> </paragraph> <paragraph num="(5)"> <text>“Assessment fee” means the fee the participant is required to pay as a condition of eligibility for the ICS Program and Medical Assistance benefits.</text> </paragraph> <paragraph num="(6)"> <text>“Assistance” means that another individual:</text> <paragraph num="(a)"> <text>Physically performs an activity for the participant;</text> </paragraph> <paragraph num="(b)"> <text>Physically helps the participant to perform an activity;</text> </paragraph> <paragraph num="(c)"> <text>Is present while the participant performs an activity because the participant's safety or health may be jeopardized if the activity is not monitored or performed due to the participant's physical or mental status; or</text> </paragraph> <paragraph num="(d)"> <text>Cues or encourages the participant to perform the activity.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14 and enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .37 of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Attendant” means an individual who provides a participant with attendant care services.</text> </paragraph> <paragraph num="(9)"> <text>“Attendant care provider agency” means an agency that is enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .30 of this chapter.</text> </paragraph> <paragraph num="(10)"> <text>“Attendant Care Services” means assistance with activities of daily living, instrumental activities of daily living, and performance of delegated nursing functions.</text> </paragraph> <paragraph num="(11)"> <text>“Case management agency” means an agency enrolled by the Maryland Medical Assistance Program to provide case management services to ICS applicants and participants.</text> </paragraph> <paragraph num="(12)"> <text>“Case management services” means services that assist an applicant or a participant to gain access to ICS services, Medicaid State Plan services, and other community services.</text> </paragraph> <paragraph num="(13)"> <text>“Delegated nursing functions” means services, other than assistance with activities of daily living and instrumental activities of daily living, provided to a participant by:</text> <paragraph num="(a)"> <text>An enrolled attendant under the supervision of an enrolled licensed registered nurse in accordance with COMAR 10.27.11; or</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner in accordance with COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department.</text> </paragraph> <paragraph num="(15)"> <text>“Determination” means a decision by the Department regarding an applicant's or participant's eligibility for the ICS Program.</text> </paragraph> <paragraph num="(16)"> <text>“Fiscal intermediary” means an agency that is under contract with the Department to provide fiscal intermediary services.</text> </paragraph> <paragraph num="(17)"> <text>“Fiscal intermediary services” means certain employer-related payroll functions, such as State and federal tax withholding and Social Security withholding, performed on behalf of participants who elect to use the participant-employed model of attendant care services.</text> </paragraph> <paragraph num="(18)"> <text>Home.</text> <paragraph num="(a)"> <text>“Home” means the place where the participant resides.</text> </paragraph> <paragraph num="(b)"> <text>“Home” does not include a hospital, nursing facility, or other institution that is regulated under:</text> <paragraph num="(i)"> <text>COMAR 10.22.03 for licensed community-based residential facilities for individuals with intellectual or developmental disabilities; or</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.21.22 for residential rehabilitation programs for individuals with serious or chronic mental illness.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>"Increased Community Services (ICS) Program” means the Medicaid home and community-based services program implemented under this chapter in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(20)"> <text>“Instrumental activities of daily living” means tasks or activities that include:</text> <paragraph num="(a)"> <text>Preparing a light meal;</text> </paragraph> <paragraph num="(b)"> <text>Performing light chores;</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries;</text> </paragraph> <paragraph num="(d)"> <text>Traveling beyond a walking distance;</text> </paragraph> <paragraph num="(e)"> <text>Managing finances and handling money;</text> </paragraph> <paragraph num="(f)"> <text>Using the telephone; and</text> </paragraph> <paragraph num="(g)"> <text>Planning and making decisions.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Maryland Medical Assistance Program” means the Program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for low income and medically indigent persons.</text> </paragraph> <paragraph num="(22)"> <text>“Medicaid” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(23)"> <text>“Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically disabled adults who, because of the degree of impairment, need health maintenance and restorative services that support their community living.</text> </paragraph> <paragraph num="(24)"> <text>“Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically disabled adults who do not require 24-hour inpatient care, but because of the degree of impairment, are not capable of full-time independent living.</text> </paragraph> <paragraph num="(25)"> <text>“Medically necessary” means the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Nurse” means an individual who is currently licensed to practice nursing in the State.</text> </paragraph> <paragraph num="(27)"> <text>“Nurse monitor” means a registered nurse who provides nursing supervision of attendants in accordance with COMAR 10.27.11 and this chapter.</text> </paragraph> <paragraph num="(28)"> <text>“Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02.</text> </paragraph> <paragraph num="(29)"> <text>“Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of a mental or physical condition, require skilled nursing care and related services, rehabilitative services, or, on a regular basis, health-related care and services above the level of room and board.</text> </paragraph> <paragraph num="(30)"> <text>“Nursing supervision” means a nurse monitor's supervision of an attendant in accordance with COMAR 10.27.11 and this chapter.</text> </paragraph> <paragraph num="(31)"> <text>“Participant” means an individual who meets the qualifications for participation in the ICS program as specified in Regulation .03 of this chapter and is enrolled with the Department to receive ICS services.</text> </paragraph> <paragraph num="(32)"> <text>“Participant-employed attendant” means an attendant who does not work for an attendant care provider agency and who may be chosen, trained, supervised, and fired by the participant.</text> </paragraph> <paragraph num="(33)"> <text>“Participant-employed model” means the delivery of attendant care services when:</text> <paragraph num="(a)"> <text>An ICS participant chooses the attendant who will render services;</text> </paragraph> <paragraph num="(b)"> <text>The attendant is an enrolled Medicaid provider; and</text> </paragraph> <paragraph num="(c)"> <text>The participant utilizes services of a fiscal intermediary.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Plan of care” means the recommended or revised recommended service plan developed by AERS after an evaluation of an applicant or participant.</text> </paragraph> <paragraph num="(35)"> <text>“Plan of service” means the written plan that:</text> <paragraph num="(a)"> <text>Is developed jointly by the applicant or participant and the case manager;</text> </paragraph> <paragraph num="(b)"> <text>Is based upon:</text> <paragraph num="(i)"> <text>The AERS evaluation;</text> </paragraph> <paragraph num="(ii)"> <text>The AERS plan of care; and</text> </paragraph> <paragraph num="(iii)"> <text>The case manager's face-to-face interview with the applicant or participant;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Addresses the applicant's or participant's needs and desires; and</text> </paragraph> <paragraph num="(d)"> <text>Specifies the type, amount, frequency, costs, and duration of all ICS and other Medicaid services required to safely support the participant in the community.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Provider” means an entity which is enrolled in the Maryland Medical Assistance Program to provide one or more of the services covered under Regulations .22 — .37 of this chapter.</text> </paragraph> <paragraph num="(37)"> <text>“Quality plan” means the plan developed by the Department to address quality assurance and oversight for the ICS program.</text> </paragraph> <paragraph num="(38)"> <text>“Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(39)"> <text>“Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in, or associated with, an individual’s place of residence.</text> </paragraph> <paragraph num="(40)"> <text>“State Plan” means the document approved by the Centers for Medicare and Medicaid Services describing the nature and scope of the Maryland Medical Assistance Program in accordance with federal requirements at §1902(a) of Title XIX of the Social Security Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>To be eligible for participation in the ICS Program, an applicant or participant shall be determined by the Department to meet the conditions of §§B — E of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A participant's eligibility for ICS services shall be reevaluated by the Department every 12 months or more frequently if needed due to a significant change in the participant's condition, needs, or financial status.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall have 45 days from the date of a complete application to make an eligibility determination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technical Eligibility. To be eligible for the services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria for ICS services if the individual:</text> <paragraph num="(1)"> <text>Had been living in a nursing facility at the time of application and for at least the last 6 months before the date of application and meets all eligibility requirements before transitioning into the community;</text> </paragraph> <paragraph num="(2)"> <text>Had been eligible for Medicaid for at least 30 consecutive days immediately before being enrolled in the ICS Program;</text> </paragraph> <paragraph num="(3)"> <text>Is not otherwise eligible for services covered under:</text> <paragraph num="(a)"> <text>The authority of §1915(c) of Title XIX of the Social Security Act; or</text> </paragraph> <paragraph num="(b)"> <text>The Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is at least 18 years old;</text> </paragraph> <paragraph num="(5)"> <text>Has a plan of service that:</text> <paragraph num="(a)"> <text>Includes Medical Assistance and ICS services necessary to safely serve the participant in the community; and</text> </paragraph> <paragraph num="(b)"> <text>Is determined by the Department to cost less than the cost to Medicaid if the individual were to remain in the institution;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is offered the choice between ICS and nursing facility services;</text> </paragraph> <paragraph num="(7)"> <text>Chooses, or the individual’s authorized representative chooses on the individual’s behalf, to receive ICS services;</text> </paragraph> <paragraph num="(8)"> <text>Is being discharged from a nursing facility into ICS services in the community and would be institutionalized in a nursing facility if not for the ICS services;</text> </paragraph> <paragraph num="(9)"> <text>Resides in a home, as defined under Regulation .02B of this chapter; and</text> </paragraph> <paragraph num="(10)"> <text>Uses at least one ICS service within a 12-month period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medical Eligibility.</text> <paragraph num="(1)"> <text>An applicant shall be determined by the Department’s utilization control agent to need nursing facility services covered under COMAR 10.09.10.</text> </paragraph> <paragraph num="(2)"> <text>Every 12 months, or more frequently if determined necessary by the Department due to a significant change in the participant's condition or needs, AERS shall revaluate the participant to verify the continued need for nursing facility services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Financial Eligibility. An ICS participant shall:</text> <paragraph num="(1)"> <text>Without regard to any assets of a spouse, meet the resource limit for Long-Term Care Medical Assistance set forth in COMAR 10.09.24.08M;</text> </paragraph> <paragraph num="(2)"> <text>Receive income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, without regard to any income of a spouse, that exceeds 300 percent of the current monthly Supplemental Security Income payment rate, known as the Federal Benefit Rate (FBR);</text> </paragraph> <paragraph num="(3)"> <text>Pay to the Department an assessment fee equal to the amount by which income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, exceeds 300 percent of the FBR, as follows:</text> <paragraph num="(a)"> <text>The initial assessment shall be paid to the Department not later than 15 days from the date of the assessment invoice sent by the Department to the participant, unless the exception in §D(4) of this regulation applies;</text> </paragraph> <paragraph num="(b)"> <text>Subsequent assessments shall be paid on or before the last day of the month on which the assessment invoice is sent to the participant by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>If a participant receives a past due notice, the participant has 15 days from the date of the notice to remit payment; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be allowed an exception to the initial monthly assessment if discharged from the nursing facility on a date other than the first of the month, in which case the participant shall be required to pay the first assessment before the first day of the first full month of ICS participation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Medical Assistance Eligibility.</text> <paragraph num="(1)"> <text>An individual is not eligible to receive ICS services during a penalty period under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets or establishment of a trust.</text> </paragraph> <paragraph num="(2)"> <text>All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to ICS applicants and participants, with the following exceptions:</text> <paragraph num="(a)"> <text>COMAR 10.09.24.06B(2)(a)(ii);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.24.08G(1);</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.24.08H;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24.10B(2) — (3);</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.09.24.10C;</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.09.24.10D(2)(a), (b), and (h);</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.09.24.10D(3) — (6);</text> </paragraph> <paragraph num="(h)"> <text>COMAR 10.09.24.10-1B(1);</text> </paragraph> <paragraph num="(i)"> <text>COMAR 10.09.24.10-1B(4);</text> </paragraph> <paragraph num="(j)"> <text>COMAR 10.09.24.10-1B(7);</text> </paragraph> <paragraph num="(k)"> <text>COMAR 10.09.24.10-1C(3)(a); and</text> </paragraph> <paragraph num="(l)"> <text>COMAR 10.09.24.15A-2(2).</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Cost of Care.</text> <paragraph num="(1)"> <text>For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order:</text> <paragraph num="(a)"> <text>A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's monthly charge to the participant for room and board; and</text> </paragraph> <paragraph num="(b)"> <text>Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f) and (g).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services.</text> </paragraph> <paragraph num="(3)"> <text>The participant shall pay the assisted living services provider directly for the participant’s cost of care and room and board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Participant Cap and Registry for ICS Participation.</text> <paragraph num="(1)"> <text>The Department shall establish a cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), on the number of participants who may receive the services covered under this chapter at any one time, based on available State and federal funding.</text> </paragraph> <paragraph num="(2)"> <text>Eligible individuals shall be enrolled in the ICS Program on a first-come, first-served basis until the participant cap is reached.</text> </paragraph> <paragraph num="(3)"> <text>Once the CMS-approved participant cap is reached, a registry of applicants shall be established by the Department on a first-come, first-served basis.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Termination of Participation. A participant shall be terminated from participation in the ICS Program if the participant:</text> <paragraph num="(1)"> <text>No longer meets the eligibility requirements specified in §§B — E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the ICS Program;</text> </paragraph> <paragraph num="(3)"> <text>Moves to another state;</text> </paragraph> <paragraph num="(4)"> <text>Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or</text> </paragraph> <paragraph num="(5)"> <text>Dies.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Re-Entering the ICS Program.</text> <paragraph num="(1)"> <text>If a participant is terminated from the ICS Program, the same individual may re-enter the ICS Program, provided:</text> <paragraph num="(a)"> <text>That the individual meets all of the requirements §§B — E of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>There is available capacity.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual cannot find a community residence before his or her application expires, the individual may reapply to the ICS Program as long as the individual continues to meet all other eligibility requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Provider Participation — General Requirements."> <paragraph num="A."> <text>To participate as a provider of a service covered under Regulations .22 — .37 of this chapter, a provider shall:</text> <paragraph num="(1)"> <text>Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Meet the licensure and certification requirements specified in this chapter, if applicable;</text> </paragraph> <paragraph num="(3)"> <text>Meet the applicable conditions for provider participation in this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Apply in accordance with the conditions of participation under Regulations .05 — .20 of this chapter, by completing the application forms designated by the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(5)"> <text>Have a signed provider agreement in effect with the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(6)"> <text>Verify the qualifications of all individuals who render ICS services on the provider's behalf, and provide a copy of the current license or credentials of these individuals upon request;</text> </paragraph> <paragraph num="(7)"> <text>Provide services in accordance with:</text> <paragraph num="(a)"> <text>A participant's plan of service;</text> </paragraph> <paragraph num="(b)"> <text>The provider agreement;</text> </paragraph> <paragraph num="(c)"> <text>The ICS Program; and</text> </paragraph> <paragraph num="(d)"> <text>All relevant federal, State, and local laws and regulations;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Agree to inform the case manager within 24 hours, and within 7 calendar days file a written report on a form designated by the Department, in the case of any threat to the health, safety, or welfare of the participant such as:</text> <paragraph num="(a)"> <text>Potential eviction;</text> </paragraph> <paragraph num="(b)"> <text>Suspected abuse or neglect; or</text> </paragraph> <paragraph num="(c)"> <text>Significant interruption of service;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Immediately notify the Adult Protective Services office at the local department of social services and law enforcement if the provider believes that the participant has been subjected to abuse, neglect, self-neglect, or exploitation in the community, in accordance with COMAR 07.06.14.04;</text> </paragraph> <paragraph num="(10)"> <text>Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives;</text> </paragraph> <paragraph num="(11)"> <text>Agree to provide services, and to subsequently bill the Department in accordance with the payment procedures specified at Regulation .40 of this chapter for only covered services which have been:</text> <paragraph num="(a)"> <text>Preapproved in the participant's plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Provided in a manner consistent with the participant's plan of service; and</text> </paragraph> <paragraph num="(c)"> <text>Authorized in the provider agreement as within the scope of the provider's Medicaid participation;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Agree to maintain and have available written documentation of ICS services, including dates and hours of services provided to participants for a period of 6 years, in a manner approved by the Department;</text> </paragraph> <paragraph num="(13)"> <text>Agree not to suspend, terminate, increase, or reduce services for a participant without authorization from the participant’s case manager; and</text> </paragraph> <paragraph num="(14)"> <text>Agree to comply with the requirements in the Department's quality plan for the ICS Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have:</text> <paragraph num="(1)"> <text>Been subject to sanctions under COMAR 10.09.36.08;</text> </paragraph> <paragraph num="(2)"> <text>Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services;</text> </paragraph> <paragraph num="(3)"> <text>Been subject to a disciplinary action by a licensing board;</text> </paragraph> <paragraph num="(4)"> <text>Been cited by a State agency for deficiencies which affect recipients' health and safety; or</text> </paragraph> <paragraph num="(5)"> <text>Been terminated under a reimbursement agreement with or been barred from work or participation by a public or private agency due to:</text> <paragraph num="(a)"> <text>Failure to meet contractual obligations; or</text> </paragraph> <paragraph num="(b)"> <text>Fraudulent billing practices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider who renders health-related services to participants, including attendants, participant trainers, occupational therapists, speech and language therapists, physical therapists, nutritionists, dietitians, medical day care centers, and registered nurses, shall agree to:</text> <paragraph num="(1)"> <text>Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Share and discuss the documented information at the request of the participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Specific Conditions for Provider Participation — Participant Training."> <text>To participate in the ICS Program as a provider of participant training under Regulation .22 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B and C of this regulation;</text> </paragraph> <paragraph num="B."> <text>Demonstrate experience in the skill being taught; and</text> </paragraph> <paragraph num="C."> <text>Be willing to meet at the participant's home to provide services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for Provider Participation — Family Training."> <text>To participate in the ICS Program as a provider of family training services under Regulation .23 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be:</text> <paragraph num="(1)"> <text>One of the following self-employed professionals:</text> <paragraph num="(a)"> <text>Registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07;</text> </paragraph> <paragraph num="(b)"> <text>Occupational therapist licensed according to COMAR 10.46.01;</text> </paragraph> <paragraph num="(c)"> <text>Speech-language pathologist licensed according to COMAR 10.41.03; or</text> </paragraph> <paragraph num="(d)"> <text>Physical therapist licensed according to COMAR 10.38.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An agency which employs or contracts with a licensed professional specified in §A(1) of this regulation who will render the service; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Demonstrate experience in the skill being taught.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for Provider Participation — Case Management Services."> <text>To participate in the ICS Program as a provider of case management services under Regulation .24 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be enrolled as a case management provider in accordance with COMAR 10.09.55.15-3;</text> </paragraph> <paragraph num="B."> <text>Accept all referrals from the Department, or other designated agency; and</text> </paragraph> <paragraph num="C."> <text>Be monitored by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for Provider Participation — Transition Services."> <text>To participate in the ICS Program as a provider of transition services under Regulation .25 of this chapter, a provider shall be the case management provider in accordance with Regulation .07 of this chapter and shall:</text> <paragraph num="A."> <text>Assist individuals to transition from a nursing facility to a community-based residence; and</text> </paragraph> <paragraph num="B."> <text>Arrange and coordinate the services necessary to facilitate the transition.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Specific Conditions for Provider Participation — Environmental Assessments."> <text>To participate in the ICS Program as a provider of environmental assessments under Regulation .26 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist;</text> </paragraph> <paragraph num="B."> <text>Receive a referral from the participant's case manager, based on services preauthorized in the plan of service; and</text> </paragraph> <paragraph num="C."> <text>Document the provider's findings and recommendations on a form approved by the Maryland Medical Assistance Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Specific Conditions for Provider Participation — Environmental Accessibility Adaptations."> <paragraph num="A."> <text>To participate in the ICS Program as a provider of environmental accessibility adaptations under Regulation .27 of this chapter, a provider shall:</text> <paragraph num="(1)"> <text>Be the store, vendor, or contractor, from which the adaptation is purchased;</text> </paragraph> <paragraph num="(2)"> <text>Provide or arrange for any required installation, servicing, or training; and</text> </paragraph> <paragraph num="(3)"> <text>Provide services according to a written schedule indicating an estimated start date and completion date.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If construction is involved, the provider shall also meet the following requirements:</text> <paragraph num="(1)"> <text>Be properly licensed by the State as a contractor or builder;</text> </paragraph> <paragraph num="(2)"> <text>Be properly bonded;</text> </paragraph> <paragraph num="(3)"> <text>Obtain all necessary State and local permits;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the work passes the required inspections; and</text> </paragraph> <paragraph num="(5)"> <text>Perform all work in accordance with State and local building codes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Specific Conditions for Provider Participation — Personal Emergency Response Systems."> <text>To participate in the ICS Program as a provider of personal emergency response systems under Regulation .28 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be the store, vendor, organization, or company which sells, rents, installs, services, or runs the device or service;</text> </paragraph> <paragraph num="B."> <text>Provide or arrange for any installation, servicing, training, or monitoring required for the device or system; and</text> </paragraph> <paragraph num="C."> <text>Assure that any response center is:</text> <paragraph num="(1)"> <text>Responsible for monitoring or responding to a notification of an emergency by the system; and</text> </paragraph> <paragraph num="(2)"> <text>Adequately staffed 24 hours a day, 7 days a week by properly trained staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Specific Conditions for Provider Participation — Assistive Technology."> <text>To participate in the ICS Program as a provider of assistive technology services under Regulation .29 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be one of the following entities:</text> <paragraph num="(1)"> <text>The store, vendor, organization, or company which sells or rents the equipment or system; or</text> </paragraph> <paragraph num="(2)"> <text>A Maryland Medical Assistance Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide or arrange for any installation, servicing, training, or monitoring required for the proper operation of the equipment or system; and</text> </paragraph> <paragraph num="C."> <text>Provide services in accordance with written estimated start and completion dates.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Specific Conditions for Provider Participation — Attendant Care Services."> <paragraph num="A."> <text>To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant shall:</text> <paragraph num="(1)"> <text>Be a participant-employed or agency-employed attendant;</text> </paragraph> <paragraph num="(2)"> <text>Be at least 18 years old;</text> </paragraph> <paragraph num="(3)"> <text>Be legally eligible for employment rendering attendant care services in the State;</text> </paragraph> <paragraph num="(4)"> <text>Be able to communicate, read, write, and follow directions in English;</text> </paragraph> <paragraph num="(5)"> <text>Be currently certified from a nationally recognized organization in the following areas:</text> <paragraph num="(a)"> <text>Cardiopulmonary resuscitation; and</text> </paragraph> <paragraph num="(b)"> <text>Basic first aid;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Receive instruction and training on the attendant care services required in the participant's plan of service from the nurse monitor before rendering services;</text> </paragraph> <paragraph num="(7)"> <text>Be supervised by a nurse monitor in accordance with the requirements of Regulation .31 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Accept instruction and training from:</text> <paragraph num="(a)"> <text>The participant;</text> </paragraph> <paragraph num="(b)"> <text>The nurse monitor;</text> </paragraph> <paragraph num="(c)"> <text>The case manager;</text> </paragraph> <paragraph num="(d)"> <text>A treating physician;</text> </paragraph> <paragraph num="(e)"> <text>Other involved professionals; or</text> </paragraph> <paragraph num="(f)"> <text>A Department representative;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Submit to a pre-employment criminal background investigation for which the individual shall:</text> <paragraph num="(a)"> <text>Submit an application for a criminal history record check to the Criminal Justice Information System Office, Department of Public Safety and Correctional Services;</text> </paragraph> <paragraph num="(b)"> <text>Direct the Department of Public Safety and Correctional Services to send the criminal history report to the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Pay for the criminal history record check and report; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Agree to submit written documentation of services rendered to each participant to the case manager on a form designated by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant may not:</text> <paragraph num="(1)"> <text>Be a spouse;</text> </paragraph> <paragraph num="(2)"> <text>Be a parent of a dependent child;</text> </paragraph> <paragraph num="(3)"> <text>Be an individual who has full and unrestricted powers of guardianship;</text> </paragraph> <paragraph num="(4)"> <text>Render services to any participant before being evaluated by a nurse monitor as able to:</text> <paragraph num="(a)"> <text>Understand and carry out the attendant care services specified in the participant's plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Perform the required duties;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Unless meeting the conditions of §C of this regulation, have been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude, drugs, or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or</text> </paragraph> <paragraph num="(6)"> <text>Be listed on the Maryland Geriatric Nursing Assistants Registry or any other registry with a determination of abuse, misappropriation of property, or neglect.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If requested by the provider applicant, the Department may waive the provisions of §B(5) of this regulation if the applicant demonstrates that:</text> <paragraph num="(1)"> <text>The conviction, probation before judgment, or a plea of nolo contendere to a felony or any crime involving moral turpitude, drugs, or theft was entered more than 10 years before the date of the provider application; and</text> </paragraph> <paragraph num="(2)"> <text>The criminal history does not indicate behavior that is potentially harmful to participants.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If required to perform any delegated nursing functions as defined in Regulation .02B of this chapter, an attendant who meets the requirements of §§A and B of this regulation, shall also:</text> <paragraph num="(1)"> <text>Be certified as:</text> <paragraph num="(a)"> <text>A nursing assistant in accordance with COMAR 10.39.01; or</text> </paragraph> <paragraph num="(b)"> <text>If required to administer medications:</text> <paragraph num="(i)"> <text>Certified medicine aide in accordance with COMAR 10.39.03; or</text> </paragraph> <paragraph num="(ii)"> <text>Medication technician in accordance with COMAR 10.39.04;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be supervised by a nurse monitor; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with the requirements of the Maryland Board of Nursing as set forth in COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="E."> <text>To participate in the ICS Program as an agency provider of attendant care services, a provider agency shall:</text> <paragraph num="(1)"> <text>Be one of the following:</text> <paragraph num="(a)"> <text>A public or private agency that has been approved by the Department of Human Services, in accordance with COMAR 07.06.14;</text> </paragraph> <paragraph num="(b)"> <text>A Medicaid provider of:</text> <paragraph num="(i)"> <text>Home health services under COMAR 10.09.04; or</text> </paragraph> <paragraph num="(ii)"> <text>Personal care services under COMAR 10.09.20.03B; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A residential services agency certified in accordance with COMAR 10.07.05;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Employ or contract with attendants, who meet the requirements in §§A — C of this regulation, in sufficient numbers to ensure that a qualified attendant is available to provide the attendant care services ordered in the plan of service;</text> </paragraph> <paragraph num="(3)"> <text>Supervise each attendant who is employed by or under contract with the attendant care provider agency;</text> </paragraph> <paragraph num="(4)"> <text>Employ or contract with licensed registered nurses to act as nurse monitors and provide nursing supervision, in accordance with Regulations .14 and .31 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Be available to give instructions to attendants and to answer questions during a normal working day, including having a nurse monitor available to respond to medical or health-related issues that are within the scope of the nurse's license;</text> </paragraph> <paragraph num="(6)"> <text>Keep accurate records on each participant receiving attendant care services from the agency, which contain:</text> <paragraph num="(a)"> <text>The plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Identification of each attendant providing services to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Dates and times when attendants worked;</text> </paragraph> <paragraph num="(d)"> <text>Tasks the attendants performed;</text> </paragraph> <paragraph num="(e)"> <text>Nurse monitors' instructions to the attendants; and</text> </paragraph> <paragraph num="(f)"> <text>Progress notes and observations on the attendant and the participant;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Keep records and submit reports as required by the Department;</text> </paragraph> <paragraph num="(8)"> <text>Maintain 24-hour availability by beeper for emergencies; and</text> </paragraph> <paragraph num="(9)"> <text>Submit written documentation of services rendered to each participant as required by the Maryland Medical Assistance Program and on a form designated by the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Exemptions.</text> <paragraph num="(1)"> <text>Subject to approval by the Department, participant-employed attendants may be exempted from the qualifications described at §A(2), (4), and (5) of this regulation at the request of the participant.</text> </paragraph> <paragraph num="(2)"> <text>Providers that have been exempted from any qualification may only serve the participant or participants who have requested the exemption.</text> </paragraph> <paragraph num="(3)"> <text>The Department may:</text> <paragraph num="(a)"> <text>Grant exemptions; and</text> </paragraph> <paragraph num="(b)"> <text>Revoke exemptions for cause.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Specific Conditions for Provider Participation — Nursing Supervision of Attendants."> <paragraph num="A."> <text>To participate in the ICS Program as a provider of nursing supervision of attendants under Regulation .31 of this chapter, a provider shall be:</text> <paragraph num="(1)"> <text>A self-employed registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07; or</text> </paragraph> <paragraph num="(2)"> <text>An agency or clinic which employs registered nurses or nurse practitioners licensed according to COMAR 10.27.01 and 10.27.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The registered nurse or nurse practitioner who renders nursing supervision services shall:</text> <paragraph num="(1)"> <text>Be an individual who is:</text> <paragraph num="(a)"> <text>Self-employed; or</text> </paragraph> <paragraph num="(b)"> <text>Employed by or under contract with an agency as specified in §A(2) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of the Maryland Board of Nursing regarding nursing services and delegation of nursing functions in accordance with COMAR 10.27.11;</text> </paragraph> <paragraph num="(3)"> <text>Be willing to delegate nursing tasks to unlicensed, certified individuals according to COMAR 10.27.11; and</text> </paragraph> <paragraph num="(4)"> <text>Maintain detailed, written documentation of services rendered to participants including progress notes and service outcomes, as specified by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A provider shall ensure that a nurse monitor is available to provide the nursing supervision services specified in Regulation .31 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Specific Conditions for Provider Participation — Home Delivered Meals."> <text>To participate in the ICS Program as a provider of home-delivered meals under Regulation .32 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be approved and monitored by the Department; and</text> </paragraph> <paragraph num="B."> <text>Use a cooking facility or food preparation site that:</text> <paragraph num="(1)"> <text>Has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and</text> </paragraph> <paragraph num="(2)"> <text>Is approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Specific Conditions for Provider Participation — Dietitian and Nutritionist Services."> <text>To participate in the ICS Program as a provider of dietitian and nutritionist services under Regulation .33 of this chapter, a provider shall be a:</text> <paragraph num="A."> <text>Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Specific Conditions for Participation — Behavior Consultation Services."> <text>To participate in the ICS Program as a provider of behavior consultation services, as specified in Regulation .34 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be:</text> <paragraph num="(1)"> <text>A health services agency that:</text> <paragraph num="(a)"> <text>Employs a qualified individual or individuals to render behavior consultation services; and</text> </paragraph> <paragraph num="(b)"> <text>Assures supervision of, or consultation to, the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience in psychogeriatrics or with an appropriate graduate degree; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual who is:</text> <paragraph num="(a)"> <text>Qualified to render behavior consultation services; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed to practice independently;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Assure that the individual who renders behavior consultation services:</text> <paragraph num="(1)"> <text>Is a licensed Registered nurse; Psychologist; or Clinical social worker; and</text> </paragraph> <paragraph num="(2)"> <text>Has:</text> <paragraph num="(a)"> <text>Experience in psychogeriatrics;</text> </paragraph> <paragraph num="(b)"> <text>Direct experience working with elderly individuals with dementia or behavioral problems; and</text> </paragraph> <paragraph num="(c)"> <text>Demonstrated ability to perform assessments; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Specific Conditions for Provider Participation — Medical Day Care."> <text>To participate in the ICS Program as a provider of medical day care services under Regulation .35 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be licensed according to COMAR 10.12.04; and</text> </paragraph> <paragraph num="B."> <text>Meet the requirements of COMAR 10.09.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Specific Conditions for Participation — Senior Center Plus."> <text>To participate in the ICS Program as a provider of Senior Center Plus services, as specified in Regulation .36 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be approved and monitored by the Maryland Department of Aging as a nutrition service provider;</text> </paragraph> <paragraph num="B."> <text>Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities;</text> </paragraph> <paragraph num="C."> <text>Assure that the facility is accessible to individuals with disabilities;</text> </paragraph> <paragraph num="D."> <text>Maintain adequate records on participants, including progress notes and outcomes;</text> </paragraph> <paragraph num="E."> <text>Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels;</text> </paragraph> <paragraph num="F."> <text>Employ as the center's manager or in another staff position an individual who:</text> <paragraph num="(1)"> <text>Is a licensed health professional or a licensed social worker;</text> </paragraph> <paragraph num="(2)"> <text>Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility;</text> </paragraph> <paragraph num="(3)"> <text>Is literate and able to communicate in English; and</text> </paragraph> <paragraph num="(4)"> <text>Participates in training specified and approved by the Maryland Department of Aging;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provide Senior Center Plus services, as specified in Regulation .36 of this chapter, to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting;</text> </paragraph> <paragraph num="H."> <text>Serve at least one nutritional meal per day that:</text> <paragraph num="(1)"> <text>Is prepared in a licensed food service establishment;</text> </paragraph> <paragraph num="(2)"> <text>Meets at least one-third of the daily recommended dietary allowance; and</text> </paragraph> <paragraph num="(3)"> <text>Does not constitute a full nutritional regimen of three meals per day;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and</text> </paragraph> <paragraph num="J."> <text>Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Specific Conditions for Participation — Assisted Living."> <paragraph num="A."> <text>To participate in the ICS Program as an assisted living services provider, a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services:</text> <paragraph num="(a)"> <text>At the Level 2 moderate level of care or Level 3 high level of care; and</text> </paragraph> <paragraph num="(b)"> <text>For the level of care needed by each participant residing in the facility, including any needed resident-specific waiver in accordance with COMAR 10.07.14.09;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of COMAR 10.07.14 for Assisted Living Programs;</text> </paragraph> <paragraph num="(3)"> <text>Be or employ a manager who is literate, able to communicate in English, and qualified as:</text> <paragraph num="(a)"> <text>A licensed physician;</text> </paragraph> <paragraph num="(b)"> <text>A licensed registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>A licensed practical nurse; or</text> </paragraph> <paragraph num="(d)"> <text>An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Employ an alternate assisted living manager who meets the requirements as specified in §A(3) of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Have at least one staff person per eight residents on duty at all times during daytime hours, and a staff-to-resident ratio at night sufficient to provide the required services and maintain the facility in a safe and orderly condition, and such additional staffing as required by the Department or the Maryland Department of Aging depending on residents' functional levels;</text> </paragraph> <paragraph num="(6)"> <text>Participate in training on the ICS Program billing process and other ICS Program requirements, as specified by the Department and the Maryland Department of Aging;</text> </paragraph> <paragraph num="(7)"> <text>Have appropriate insurance coverage for the provider and its employees and vehicles if the provider transports participants to medical, social, recreational, and other services;</text> </paragraph> <paragraph num="(8)"> <text>Cooperate with other service providers and quality assurance monitors by:</text> <paragraph num="(a)"> <text>Facilitating on-site visits of authorized quality assurance monitors to review compliance with ICS and regulatory requirements;</text> </paragraph> <paragraph num="(b)"> <text>Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs;</text> </paragraph> <paragraph num="(c)"> <text>Communicating with a participant's case manager concerning the participant's status, needs, and service provision;</text> </paragraph> <paragraph num="(d)"> <text>Informing the case manager within 1 working day of any significant change in the participant's status and service needs;</text> </paragraph> <paragraph num="(e)"> <text>Facilitating, as necessary and appropriate, the delivery of authorized ICS and State Plan services in the plan of service; and</text> </paragraph> <paragraph num="(f)"> <text>Facilitating the ICS participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Submit claims consistent with the provisions of Regulation .40 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall:</text> <paragraph num="(1)"> <text>Be provided to all residents and, where appropriate, the resident's representative, at admission;</text> </paragraph> <paragraph num="(2)"> <text>Be fairly and consistently applied to all residents;</text> </paragraph> <paragraph num="(3)"> <text>Specify that the bed reservation service is not a Medicaid covered service;</text> </paragraph> <paragraph num="(4)"> <text>Clearly state that it is the resident's decision whether to reserve the bed; and</text> </paragraph> <paragraph num="(5)"> <text>Specify that the participant's payments for bed reservation days may not exceed the full Medicaid per diem rate for Level II or Level III assisted living services, as applicable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Designated Units. An assisted living provider may limit Medicaid participation to designated units only if approved by the Maryland Department of Aging and the facility resident agreement contains the following provision: The facility's participation in the Maryland Medical Assistance Program is limited to one or more designated units and, in order to access Medicaid benefits, the resident shall reside in a designated unit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Covered Services — General."> <text>The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter when, pursuant to the requirements of this chapter, these services have been preapproved by the Department in the participant's plan of service and documented as:</text> <paragraph num="A."> <text>Necessary to prevent institutionalization in a nursing facility; and</text> </paragraph> <paragraph num="B."> <text>Cost-neutral to the ICS Program, in accordance with Regulation .38E of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Covered Services — Participant Training."> <paragraph num="A."> <text>Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider to a participant, not including the time spent by the provider:</text> <paragraph num="(1)"> <text>Planning, preparing, or setting up the training;</text> </paragraph> <paragraph num="(2)"> <text>Following up after the training; or</text> </paragraph> <paragraph num="(3)"> <text>Traveling to and from the training.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Participant training includes instruction and skill building in such areas as how to recruit, select, train, direct, supervise, and fire participant-employed attendants, money management, budgeting, independent living, meal planning, and other areas specified in the participant's plan of service.</text> </paragraph> <paragraph num="C."> <text>The topics covered by participant training shall:</text> <paragraph num="(1)"> <text>Be specified in the participant's plan of service as necessary to safely maintain the participant at home;</text> </paragraph> <paragraph num="(2)"> <text>Be targeted to the individualized needs of the participant; and</text> </paragraph> <paragraph num="(3)"> <text>Be sensitive of the educational background, culture, and general environment of the participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Participant training shall include updates as necessary to maintain or improve skills, if these updates are in the plan of service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Covered Services — Family Training."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>“Family member” means an individual who:</text> <paragraph num="(a)"> <text>Lives with or provides assistance to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Is not paid to provide the care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Unit of service” means an hour of service rendered by a qualified provider to one or more family members at the same time in the participant's home or the provider's office, regardless of the number of family members trained at one time, not including the time spent by the provider:</text> <paragraph num="(a)"> <text>Planning, preparing, or setting up the training;</text> </paragraph> <paragraph num="(b)"> <text>Following up after the training; or</text> </paragraph> <paragraph num="(c)"> <text>Traveling to and from the training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Family training includes instruction about treatment regimens and the use of equipment specified in the plan of service.</text> </paragraph> <paragraph num="C."> <text>The topics covered by family training shall be:</text> <paragraph num="(1)"> <text>Specified in the participant's plan of service as necessary to safely maintain the participant at home;</text> </paragraph> <paragraph num="(2)"> <text>Targeted to address the individualized needs of the participant; and</text> </paragraph> <paragraph num="(3)"> <text>Sensitive of the educational background, culture, and general environment of the family member.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Family training shall include updates in the plan of service as necessary to continue to safely maintain the individual at home.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Covered Services — Case Management."> <paragraph num="A."> <text>Definition. “Unit of service” means a 15-minute increment of service rendered by a qualified provider to a participant or the participant's representative.</text> </paragraph> <paragraph num="B."> <text>Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant.</text> </paragraph> <paragraph num="C."> <text>Case management services include time spent by a qualified provider conducting any of the following activities:</text> <paragraph num="(1)"> <text>Assisting with an initial or annual ICS Program eligibility process;</text> </paragraph> <paragraph num="(2)"> <text>Assisting with an application and maintaining all public and private benefits, resources, and entitlements;</text> </paragraph> <paragraph num="(3)"> <text>Conducting an assessment of needs, and developing a person-centered plan of services, to include all services needed to live safely in the community;</text> </paragraph> <paragraph num="(4)"> <text>Assisting with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the individual's needs including, but not limited to:</text> <paragraph num="(a)"> <text>Community integration;</text> </paragraph> <paragraph num="(b)"> <text>Medical services;</text> </paragraph> <paragraph num="(c)"> <text>Social services;</text> </paragraph> <paragraph num="(d)"> <text>Educational services;</text> </paragraph> <paragraph num="(e)"> <text>Behavioral health;</text> </paragraph> <paragraph num="(f)"> <text>Legal services; and</text> </paragraph> <paragraph num="(g)"> <text>Housing;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Contacting ICS Program providers and Medicaid State Plan providers not less than monthly and documenting that services were received in the amount, type, frequency, and duration described in the plan of services;</text> </paragraph> <paragraph num="(6)"> <text>Ensuring timely receipt of all other services and documenting follow-up;</text> </paragraph> <paragraph num="(7)"> <text>Facilitating referral to other programs if the individual is denied ICS Program services; and</text> </paragraph> <paragraph num="(8)"> <text>Using information technology systems developed by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Covered Services — Transition Services."> <paragraph num="A."> <text>Definition. “Unit of service” means a one-time service that is:</text> <paragraph num="(1)"> <text>Not otherwise available under the ICS Program;</text> </paragraph> <paragraph num="(2)"> <text>Approved in the plan of service; and</text> </paragraph> <paragraph num="(3)"> <text>Rendered to a participant by a qualified provider to assist the participant in transitioning from a nursing facility or assisted living facility to independent living.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Transition services may include some or all of the following:</text> <paragraph num="(1)"> <text>Security deposits;</text> </paragraph> <paragraph num="(2)"> <text>Essential furnishings and moving expenses;</text> </paragraph> <paragraph num="(3)"> <text>Deposits or fees for utility services; and</text> </paragraph> <paragraph num="(4)"> <text>Other health and safety assurances including pest eradication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Transition services may not include recreational items such as televisions, cable TV access, or DVD players.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Covered Services — Environmental Assessments."> <paragraph num="A."> <text>Definition. “Unit of service” means the completion of:</text> <paragraph num="(1)"> <text>An on-site environmental assessment of the participant’s home; and</text> </paragraph> <paragraph num="(2)"> <text>A form approved by the Maryland Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An environmental assessment may not be provided before the effective date of the participant's eligibility for ICS Program services.</text> </paragraph> <paragraph num="C."> <text>The service may be recommended by a multidisciplinary team in the plan of service for a participant when the service is considered necessary to:</text> <paragraph num="(1)"> <text>Ensure the health and safety of a participant with special environmental needs; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain additional professional advice from an occupational therapist about the:</text> <paragraph num="(a)"> <text>Physical structure of a participant's home or residence; and</text> </paragraph> <paragraph num="(b)"> <text>Functional or mental limitations or disabilities of a participant as they relate to the environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Included in the environmental assessment, as necessary and appropriate, may be:</text> <paragraph num="(1)"> <text>An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant;</text> </paragraph> <paragraph num="(2)"> <text>Environmental factors in the facility or home;</text> </paragraph> <paragraph num="(3)"> <text>The participant's ability to perform activities of daily living;</text> </paragraph> <paragraph num="(4)"> <text>The participant's strength, range of motion, and endurance;</text> </paragraph> <paragraph num="(5)"> <text>The participant's need for assistive devices and equipment; and</text> </paragraph> <paragraph num="(6)"> <text>The participant's, family's, or service provider's knowledge of health, safety, and stress reduction factors.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Based on an inspection of the home and interviews with the participant, family, or service provider, the provider shall complete a form, to be reviewed by the case manager, which details the provider's findings and recommendations as to a participant's need for ICS Program services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Covered Services — Environmental Accessibility Adaptations."> <paragraph num="A."> <text>Definition. “Unit of service” means one or more physical adaptations to a participant's home or place of residence which is completed as one job by a qualified provider and which constitute a single accessibility adaptation.</text> </paragraph> <paragraph num="B."> <text>If the owner of the home is the participant, environmental accessibility adaptations may be made only if approved by the participant, in the participant's plan of service.</text> </paragraph> <paragraph num="C."> <text>If the owner is not the participant, environmental accessibility adaptations may be made only if approved by the owner of the home, who agrees that the participant will be allowed to remain in the residence for at least 1 year, and if approved by the participant, in the participant’s plan of service.</text> </paragraph> <paragraph num="D."> <text>Environmental accessibility adaptations shall include those physical adaptations or modifications to the participant's home which are required to make it accessible to the participant because of the:</text> <paragraph num="(1)"> <text>Physical structure of the residence; or</text> </paragraph> <paragraph num="(2)"> <text>Participant's specific functional needs.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Environmental accessibility adaptations may include but are not limited to:</text> <paragraph num="(1)"> <text>Visual fire alarms;</text> </paragraph> <paragraph num="(2)"> <text>Telecommunication type machines (TTYs);</text> </paragraph> <paragraph num="(3)"> <text>Ramps;</text> </paragraph> <paragraph num="(4)"> <text>Grab bars or handrails;</text> </paragraph> <paragraph num="(5)"> <text>Stair glides;</text> </paragraph> <paragraph num="(6)"> <text>Widening of doorways;</text> </paragraph> <paragraph num="(7)"> <text>Modification of bathroom or kitchen facilities to make them physically accessible;</text> </paragraph> <paragraph num="(8)"> <text>Specialized electrical and plumbing systems to accommodate the medical equipment and supplies which are necessary for the participant's welfare;</text> </paragraph> <paragraph num="(9)"> <text>Locks, buzzers, or other devices on doorways to prevent or stop wandering; and</text> </paragraph> <paragraph num="(10)"> <text>Home modifications to help a participant identify the physical environment.</text> </paragraph> </paragraph> <paragraph num="F."> <text>To be reimbursed, all services shall:</text> <paragraph num="(1)"> <text>Be provided in accordance with applicable State and local building codes; and</text> </paragraph> <paragraph num="(2)"> <text>Pass required inspections.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Covered Services — Personal Emergency Response Systems."> <paragraph num="A."> <text>Definition. “Unit of service” means any of the following:</text> <paragraph num="(1)"> <text>Purchase and installation;</text> </paragraph> <paragraph num="(2)"> <text>Maintenance or repair; or</text> </paragraph> <paragraph num="(3)"> <text>Monthly cost of a covered system or rented device or equipment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include:</text> <paragraph num="(1)"> <text>A device connected to the participant's telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>A portable help button to allow for the participant's mobility; and</text> </paragraph> <paragraph num="(3)"> <text>A motion detector when necessary for the participant's health, safety, and welfare.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Covered Services — Assistive Technology."> <paragraph num="A."> <text>Definition. “Unit of service” means a device or appliance that is purchased as one item, including:</text> <paragraph num="(1)"> <text>Any required training in the use of the device; and</text> </paragraph> <paragraph num="(2)"> <text>An assessment for the use of the device, if the assessment is:</text> <paragraph num="(a)"> <text>Performed directly by the provider; and</text> </paragraph> <paragraph num="(b)"> <text>Routinely included as part of the provider's cost for the item.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Assistive technology includes nonexperimental technology or adaptive equipment, excluding service animals, which enables a participant to live in the community and to participate in community activities.</text> </paragraph> <paragraph num="C."> <text>Assistive technology may include:</text> <paragraph num="(1)"> <text>Environmental control units for participants' homes to allow spontaneous or programmed control of household appliances and other home devices;</text> </paragraph> <paragraph num="(2)"> <text>Personal computers, software, and computer accessories which enable participants to function more independently;</text> </paragraph> <paragraph num="(3)"> <text>Maintenance and repair of the covered assistive technology devices and equipment;</text> </paragraph> <paragraph num="(4)"> <text>Augmentative communication and communication-enhancement devices;</text> </paragraph> <paragraph num="(5)"> <text>Aids for daily living and self-help aids used in activities such as eating, bathing, cooking, dressing, toileting, and home maintenance; and</text> </paragraph> <paragraph num="(6)"> <text>Equipment needed to adapt the participant's or family's automotive vehicle for personal transportation such as:</text> <paragraph num="(a)"> <text>Adaptive driving aids;</text> </paragraph> <paragraph num="(b)"> <text>Hand controls; and</text> </paragraph> <paragraph num="(c)"> <text>Wheelchair lifts, and other lifts used for personal transportation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>To be covered under this chapter, each item of assistive technology shall meet applicable standards of manufacture, design, usage, and installation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Covered Services — Attendant Care Services."> <paragraph num="A."> <text>Definition. “Unit of service” means an hour of service that is in the plan of service and rendered to a participant by a qualified provider in the participant's home or in a community setting.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C of this regulation, the ICS Program covers the following attendant care services:</text> <paragraph num="(1)"> <text>Assistance with activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Delegated nursing functions, such as assistance with the participant's administration of medications or other remedies, when ordered by a physician, if this assistance is:</text> <paragraph num="(a)"> <text>Specified in the participant's plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assistance with protecting a participant from harm or neglect;</text> </paragraph> <paragraph num="(4)"> <text>Assistance with instrumental activities of daily living, provided as incidental to the services covered under §B(1) — (3) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Accompanying the participant outside of the home during the participant's community activities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Attendant care services may not include:</text> <paragraph num="(1)"> <text>Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant;</text> </paragraph> <paragraph num="(2)"> <text>The cost of food or meals;</text> </paragraph> <paragraph num="(3)"> <text>Housekeeping services, other than those incidental services covered under §B(4) of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Expenses related to room and board for either the participant or the attendant;</text> </paragraph> <paragraph num="(5)"> <text>Expenses incurred while escorting a participant to obtain medical diagnosis or treatment; or</text> </paragraph> <paragraph num="(6)"> <text>Skilled medical services performed by individuals with a professional medical license or certification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Covered Services — Nursing Supervision of Attendants."> <paragraph num="A."> <text>Definition. “Unit of service” means an hour of service rendered by a nurse monitor to a participant in the participant's home or another community-based setting.</text> </paragraph> <paragraph num="B."> <text>Nursing supervision services include the following:</text> <paragraph num="(1)"> <text>Development of the participant's plan for attendant care:</text> <paragraph num="(a)"> <text>After consultation with the participant, family members, participant's personal physician, case manager, and other providers; and</text> </paragraph> <paragraph num="(b)"> <text>In conformance with the participant's:</text> <paragraph num="(i)"> <text>AERS evaluation;</text> </paragraph> <paragraph num="(ii)"> <text>AERS plan of care; and</text> </paragraph> <paragraph num="(iii)"> <text>Plan of service;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Providing health-related information and training to the attendant concerning topics related to the care, or progress, of the participant, including:</text> <paragraph num="(a)"> <text>The performance of the services in the participant's plan for attendant care; and</text> </paragraph> <paragraph num="(b)"> <text>Information that should be brought to the attention of the attendant care provider agency, the nurse monitor, personal physician, or case manager;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensuring that each attendant to be supervised by the provider meets the requirements in Regulation .13A, B, and D of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Nursing supervision of the participant's medical condition and the care rendered by an attendant, including any delegated nursing functions performed by an attendant, in accordance with COMAR 10.27.11 and the schedule specified in §B(5) of this regulation, by reviewing the:</text> <paragraph num="(a)"> <text>Participant's plan of service and specific plan for attendant care;</text> </paragraph> <paragraph num="(b)"> <text>Interactions between the participant and the attendant;</text> </paragraph> <paragraph num="(c)"> <text>Attendant's performance and ability to render the required services; and</text> </paragraph> <paragraph num="(d)"> <text>Participant's medical condition and need for attendant care services or for referral to other services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Providing the necessary type and frequency of nursing supervision required in accordance with COMAR 10.27.11, with the exception of COMAR 10.27.11.04C, including visits to a participant's home or other service delivery site for observation at least every:</text> <paragraph num="(a)"> <text>45 days if the attendant administers medications to the participant;</text> </paragraph> <paragraph num="(b)"> <text>3 months if the attendant assists the participant with self-administration of medications;</text> </paragraph> <paragraph num="(c)"> <text>4 months if the attendant does not administer medications or assist the participant with medication self-administration; or</text> </paragraph> <paragraph num="(d)"> <text>At a greater frequency established by the nurse monitor due to the participant's medical condition or clinical status;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Rendering a professional evaluation, in accordance with Regulation .13B(3) of this chapter, of a attendant's ability to carry out the participant's specific plan for attendant care; and</text> </paragraph> <paragraph num="(7)"> <text>Documenting an action plan to address health and safety or medical concerns, including missed nursing supervision visits, and providing a copy of the plan to the case management agency within 5 business days.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The services covered under this regulation may not include nursing services other than those services described in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Covered Services — Home-Delivered Meals."> <paragraph num="A."> <text>Definition. “Unit of service” means one meal delivered to the participant's home, including the cost of the food, food preparation, and delivery.</text> </paragraph> <paragraph num="B."> <text>The meal shall be intended for consumption at home.</text> </paragraph> <paragraph num="C."> <text>This service may not constitute the participant's full nutritional regimen of three meals per day.</text> </paragraph> <paragraph num="D."> <text>Each meal shall:</text> <paragraph num="(1)"> <text>Be nutritionally adequate for the participant's age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council; and</text> </paragraph> <paragraph num="(2)"> <text>Meet either of the following:</text> <paragraph num="(a)"> <text>At least one-third of the RDA or DRI; or</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic or restrictive diet requirements ordered by the participant's physician, dietitian, or nutritionist, including any ordered nutritional supplements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The ICS Program's coverage under this regulation may not:</text> <paragraph num="(1)"> <text>Result, when combined with home-delivered meals received under Title III of the Older Americans Act, in public funding for the participant's full daily nutritional regimen of three meals; or</text> </paragraph> <paragraph num="(2)"> <text>Supplant payment for home-delivered meals under Title III.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Covered Services — Dietitian and Nutritionist Services."> <paragraph num="A."> <text>Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider for a participant in the participant's home or the provider's office.</text> </paragraph> <paragraph num="B."> <text>Dietitian and nutritionist services shall include:</text> <paragraph num="(1)"> <text>The provision of a nutrition care plan as part of the ICS Program multidisciplinary team process;</text> </paragraph> <paragraph num="(2)"> <text>Nutrition care planning, nutrition assessment, and dietetic instruction; and</text> </paragraph> <paragraph num="(3)"> <text>Services within the scope of practice of the nutritionist's or dietitian's license, as defined by:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 5, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations under COMAR 10.56 for the Board of Dietetic Practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Dietitian and nutritionist services may not include services rendered on a group basis or in a classroom setting.</text> </paragraph> <paragraph num="D."> <text>The services shall be:</text> <paragraph num="(1)"> <text>Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian;</text> </paragraph> <paragraph num="(2)"> <text>Targeted to the individualized needs of the participant, rather than being of general interest;</text> </paragraph> <paragraph num="(3)"> <text>Sensitive to the educational background, culture, religion, eating habits, preferences, and general environment of the participant; and</text> </paragraph> <paragraph num="(4)"> <text>Specified in the participant's plan of service as necessary to:</text> <paragraph num="(a)"> <text>Ensure the participant's health and safety; and</text> </paragraph> <paragraph num="(b)"> <text>Prevent the participant's institutionalization or hospitalization.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Covered Services — Behavior Consultation Services."> <paragraph num="A."> <text>Definition. “Unit of service” means an hour of service rendered by a qualified individual during a home visit to a participant, not including:</text> <paragraph num="(1)"> <text>The time spent on related activities before or after the home visit; or</text> </paragraph> <paragraph num="(2)"> <text>The time spent on supervisory or consultative services to the provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §D of this regulation.</text> </paragraph> <paragraph num="C."> <text>Behavior consultation services may be preauthorized by a participant's plan of care as necessary and appropriate when:</text> <paragraph num="(1)"> <text>A participant's behavior is:</text> <paragraph num="(a)"> <text>Disruptive;</text> </paragraph> <paragraph num="(b)"> <text>Potentially dangerous to the participant's or another person's health and functioning; or</text> </paragraph> <paragraph num="(c)"> <text>Placing the participant at risk of institutionalization due to health and safety concerns; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Advice is needed as to how to manage the disruptive behavior of a participant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Behavior consultation services include a:</text> <paragraph num="(1)"> <text>Home visit by an individual qualified to render services to:</text> <paragraph num="(a)"> <text>Evaluate a participant's acute behavior change;</text> </paragraph> <paragraph num="(b)"> <text>Assess the situation;</text> </paragraph> <paragraph num="(c)"> <text>Determine the contributing factors; and</text> </paragraph> <paragraph num="(d)"> <text>Recommend interventions and treatments;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Written report prepared for review by the case manager and the assisted living services provider or the participant's family, which assesses the situation and makes recommendations; and</text> </paragraph> <paragraph num="(3)"> <text>Verbal review of the report with the case manager and the assisted living services provider or the participant's family to discuss:</text> <paragraph num="(a)"> <text>The report's findings and recommendations; and</text> </paragraph> <paragraph num="(b)"> <text>A course of action, including any related needed medical interventions.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Covered Services — Medical Day Care."> <paragraph num="A."> <text>Definition. “Unit of service” means a day of service rendered by a qualified provider to a participant in accordance with COMAR 10.09.07.</text> </paragraph> <paragraph num="B."> <text>The ICS Program reimburses for a day of care which includes the following services:</text> <paragraph num="(1)"> <text>Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following:</text> <paragraph num="(a)"> <text>Participation in the development of the individual participant's plan of care;</text> </paragraph> <paragraph num="(b)"> <text>Participation in the determination of the participant's medical, psychosocial, and functional status;</text> </paragraph> <paragraph num="(c)"> <text>Consultation with the participant's personal physician; and</text> </paragraph> <paragraph num="(d)"> <text>Consultation with staff regarding a participant's condition and health care needs;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include:</text> <paragraph num="(a)"> <text>The evaluation of the needs of the participants for nursing care;</text> </paragraph> <paragraph num="(b)"> <text>The supervision of any nursing staff;</text> </paragraph> <paragraph num="(c)"> <text>Preventive and maintenance services;</text> </paragraph> <paragraph num="(d)"> <text>Observation and monitoring of participant's condition;</text> </paragraph> <paragraph num="(e)"> <text>Rehabilitative services;</text> </paragraph> <paragraph num="(f)"> <text>The teaching and training activities in appropriate self-care techniques;</text> </paragraph> <paragraph num="(g)"> <text>The supervision of medication normally self-administered;</text> </paragraph> <paragraph num="(h)"> <text>The provision of health education;</text> </paragraph> <paragraph num="(i)"> <text>Discharge planning; and</text> </paragraph> <paragraph num="(j)"> <text>Nursing services that may be delegated to other staff in accordance with COMAR 10.27.11;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Physical therapy services, performed by or under supervision of a licensed physical therapist, that:</text> <paragraph num="(a)"> <text>Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided based on the assessment by the physician that the:</text> <paragraph num="(i)"> <text>Participant will improve significantly in a reasonable and generally predictable period of time; or</text> </paragraph> <paragraph num="(ii)"> <text>Services are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Are directly related to the physician's written plan of care which specifies:</text> <paragraph num="(i)"> <text>Part or parts to be treated;</text> </paragraph> <paragraph num="(ii)"> <text>Type of modalities or treatments to be rendered;</text> </paragraph> <paragraph num="(iii)"> <text>Expected results of physical therapy treatments; and</text> </paragraph> <paragraph num="(iv)"> <text>Frequency and duration of treatment;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The complexity of the services, or the condition of a participant, require the judgment, knowledge, and skills of a licensed physical therapist; and</text> </paragraph> <paragraph num="(d)"> <text>The services are considered to be an effective treatment according to accepted standards of medical practice;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Occupational therapy services, performed by an occupational therapist, that meet the following conditions:</text> <paragraph num="(a)"> <text>The treatment requires the special skills of an occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>The services are directly related to the physician's written plan of care which specifies the:</text> <paragraph num="(i)"> <text>Treatment to be rendered;</text> </paragraph> <paragraph num="(ii)"> <text>Frequency and duration of the treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Expected results;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and</text> </paragraph> <paragraph num="(d)"> <text>The services fall within one or more of the following categories:</text> <paragraph num="(i)"> <text>Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests;</text> </paragraph> <paragraph num="(ii)"> <text>Selection and teaching of task-oriented therapeutic activities designed to restore physical function;</text> </paragraph> <paragraph num="(iii)"> <text>Teaching of compensatory techniques to improve the level of independence in the activities of daily living;</text> </paragraph> <paragraph num="(iv)"> <text>Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and</text> </paragraph> <paragraph num="(v)"> <text>Improvement of mobility skills;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Personal care services which include assistance with activities of daily living;</text> </paragraph> <paragraph num="(6)"> <text>Nutrition services which include the following:</text> <paragraph num="(a)"> <text>Meals and snacks as specified under COMAR 10.12.04.19;</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic diets as specified under COMAR 10.12.04.19; and</text> </paragraph> <paragraph num="(c)"> <text>Dietary counseling and education;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Social work services performed by a licensed, certified social worker, or licensed social work associate which include:</text> <paragraph num="(a)"> <text>Screening and interviewing, or assisting designated staff with screening and interviewing prospective participants to determine the general appropriateness of the individual for the full assessment process for medical day care services;</text> </paragraph> <paragraph num="(b)"> <text>Ongoing services to include:</text> <paragraph num="(i)"> <text>Identifying the emotional and social needs of participants during the rendering of medical day care services;</text> </paragraph> <paragraph num="(ii)"> <text>Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers;</text> </paragraph> <paragraph num="(iii)"> <text>Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders;</text> </paragraph> <paragraph num="(iv)"> <text>Counseling a participant and a participant's family in the availability and utilization of public and private community services, referral to, and coordination of these services;</text> </paragraph> <paragraph num="(v)"> <text>Assisting participants in obtaining health care services that are not available through the medical day care center, such as vision care, podiatry, or medical equipment;</text> </paragraph> <paragraph num="(vi)"> <text>Counseling participants to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care;</text> </paragraph> <paragraph num="(vii)"> <text>Coordinating and implementing group and family counseling in conjunction with plan of care goals;</text> </paragraph> <paragraph num="(viii)"> <text>Writing notes in the participant's records that reflect the social work activities performed; and</text> </paragraph> <paragraph num="(ix)"> <text>Participating in the multidisciplinary team meetings; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Discharge planning and referral services including:</text> <paragraph num="(i)"> <text>Written procedures for discharge, referral, and follow-up;</text> </paragraph> <paragraph num="(ii)"> <text>A discharge summary with post discharge goals;</text> </paragraph> <paragraph num="(iii)"> <text>Recommendations for continuing care; and</text> </paragraph> <paragraph num="(iv)"> <text>Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Activity programs in accordance with COMAR 10.12.04.14C; and</text> </paragraph> <paragraph num="(9)"> <text>Transportation services that:</text> <paragraph num="(a)"> <text>Are provided or arranged for a participant by the medical day care staff;</text> </paragraph> <paragraph num="(b)"> <text>Maximize the following types of transportation services:</text> <paragraph num="(i)"> <text>Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile;</text> </paragraph> <paragraph num="(ii)"> <text>Family-supplied transportation provided by friends, neighbors, or volunteers; and</text> </paragraph> <paragraph num="(iii)"> <text>Public transportation services;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Are procured by the provider after options described in §B(9)(b) of this regulation have been exhausted;</text> </paragraph> <paragraph num="(d)"> <text>Are the responsibility of the provider to:</text> <paragraph num="(i)"> <text>Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and</text> </paragraph> <paragraph num="(ii)"> <text>Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Are provided in accordance with a primary transportation plan and a back-up plan;</text> </paragraph> <paragraph num="(f)"> <text>Are documented, indicating the type of transportation used by each participant;</text> </paragraph> <paragraph num="(g)"> <text>Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and</text> </paragraph> <paragraph num="(h)"> <text>Are included in the day of care for:</text> <paragraph num="(i)"> <text>Trips and outings which are part of the activities program; and</text> </paragraph> <paragraph num="(ii)"> <text>A participant's medical appointment escorted by center staff.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The day care service shall be:</text> <paragraph num="(1)"> <text>Authorized in the participant's plan of service;</text> </paragraph> <paragraph num="(2)"> <text>Medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care; and</text> </paragraph> <paragraph num="(4)"> <text>Provided to participants documented to be present at the medical day care center a minimum of 4 hours a day.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Covered Services — Senior Center Plus."> <paragraph num="A."> <text>Definition. “Unit of service” means a day of attendance by a participant for at least 4 hours, not including transportation to and from the center.</text> </paragraph> <paragraph num="B."> <text>Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly and disabled individuals, and one nutritious meal shall be provided by the center.</text> </paragraph> <paragraph num="C."> <text>This program is designed to promote the participants' optimal functioning and to improve their orientation and cognitive ability.</text> </paragraph> <paragraph num="D."> <text>A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services:</text> <paragraph num="(1)"> <text>May not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and</text> </paragraph> <paragraph num="(2)"> <text>Shall be reimbursed through some other funding source for transportation services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Senior Center Plus does not cover:</text> <paragraph num="(1)"> <text>Transportation;</text> </paragraph> <paragraph num="(2)"> <text>Direct health care; or</text> </paragraph> <paragraph num="(3)"> <text>A full regimen of three meals per day.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Covered Services — Assisted Living Facility."> <paragraph num="A."> <text>Definition. “Unit of service” means a day of service and does not include days that the participant was not residing in the provider's assisted living facility, meaning that the participant:</text> <paragraph num="(1)"> <text>Had not yet moved into the facility;</text> </paragraph> <paragraph num="(2)"> <text>Had moved out of the facility;</text> </paragraph> <paragraph num="(3)"> <text>Was an inpatient at a hospital, nursing facility, or other medical institution for one or more nights; or</text> </paragraph> <paragraph num="(4)"> <text>Was absent from the provider's facility for more than 7 nights during a calendar month at the participant's choice for personal reasons, such as to visit family or take a vacation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Assisted living services shall include the provision of:</text> <paragraph num="(1)"> <text>A structured, supportive environment in a home-like setting;</text> </paragraph> <paragraph num="(2)"> <text>Personal care and chore services including:</text> <paragraph num="(a)"> <text>Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities;</text> </paragraph> <paragraph num="(b)"> <text>Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and</text> </paragraph> <paragraph num="(c)"> <text>Menu planning, food shopping, and meal preparation and serving;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Basic personal hygiene supplies, including but not limited to:</text> <paragraph num="(a)"> <text>Soap;</text> </paragraph> <paragraph num="(b)"> <text>Bathroom tissue;</text> </paragraph> <paragraph num="(c)"> <text>Paper towels;</text> </paragraph> <paragraph num="(d)"> <text>Toothpaste;</text> </paragraph> <paragraph num="(e)"> <text>Toothbrush; and</text> </paragraph> <paragraph num="(f)"> <text>Shampoo;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>24-hour supervision of participants to assure health and safety;</text> </paragraph> <paragraph num="(5)"> <text>Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14;</text> </paragraph> <paragraph num="(6)"> <text>Recreational and social activities;</text> </paragraph> <paragraph num="(7)"> <text>Reminding the participant of medical appointments;</text> </paragraph> <paragraph num="(8)"> <text>Assistance with transportation arrangements to Program and other needed services;</text> </paragraph> <paragraph num="(9)"> <text>Conferring with the participant's case manager about the participant's status and service needs;</text> </paragraph> <paragraph num="(10)"> <text>Assisting the participant in accessing needed medical or mental health services in emergency situations; and</text> </paragraph> <paragraph num="(11)"> <text>Other services specified for assisted living programs in COMAR 10.07.14.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Assisted living services shall reflect the participants' individualized needs and preferences.</text> </paragraph> <paragraph num="D."> <text>Assisted living services reimbursed under this chapter may not include room and board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Conditions for Reimbursement."> <text>The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter, if the service:</text> <paragraph num="A."> <text>Is recommended in the applicant’s or participant's plan of service as necessary in order to:</text> <paragraph num="(1)"> <text>Prevent admission to a nursing facility;</text> </paragraph> <paragraph num="(2)"> <text>Safely deinstitutionalize the individual from a nursing facility into the community; or</text> </paragraph> <paragraph num="(3)"> <text>Assure the participant’s health and safety in the community;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Has been preapproved by the Department in the participant's plan of service;</text> </paragraph> <paragraph num="C."> <text>Is provided to an enrolled participant who meets the qualifications for eligibility specified in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="D."> <text>Is appropriate, relative to other community-based services;</text> </paragraph> <paragraph num="E."> <text>Is cost-neutral for the ICS Program after receipt of the monthly assessment fee and by calculating, on an annualized basis, the cost of services covered under this chapter and other State Plan services that are not covered for nursing facility residents; and</text> </paragraph> <paragraph num="F."> <text>Is provided by a Medicaid provider of ICS Program services who meets the appropriate conditions for participation under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Limitations."> <paragraph num="A."> <text>Reimbursement may be made by the Maryland Medical Assistance Program only if the requirements of this chapter are met.</text> </paragraph> <paragraph num="B."> <text>The total reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations and assistive technology combined is limited to the amount specified at Regulation .40C(4)(f)(ii) or (h)(ii) of this chapter during the participant’s annual plan of service period, with exceptions allowed at the Department's discretion in the following circumstances:</text> <paragraph num="(1)"> <text>The amount exceeds the limit, but will allow the individual to return home from a nursing facility or avoid immediate placement in a nursing facility, and does not exceed the participant's cost neutrality under Regulation .38E of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Expenditures in excess of the annual limit will reduce the participant's ongoing Medicaid cost of care significantly without exceeding the participant's cost neutrality.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursement for services or equipment estimated to cost more than the amount specified in Regulation .40C(4)(g)(ii) of this chapter shall be preapproved by the Department based on at least two cost estimates obtained from prospective vendors.</text> </paragraph> <paragraph num="D."> <text>Reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations covered under Regulation .27 of this chapter is limited to modifying two residences of the participant every 3 consecutive years.</text> </paragraph> <paragraph num="E."> <text>Excluded from coverage under Regulation .27 of this chapter are adaptations or improvements to the home which:</text> <paragraph num="(1)"> <text>Are of general utility, such as carpeting, roof repair, and central air conditioning;</text> </paragraph> <paragraph num="(2)"> <text>Are not of direct medical or remedial benefit to the participant; or</text> </paragraph> <paragraph num="(3)"> <text>Add to the home's total square footage.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Reimbursement by the Maryland Medical Assistance Program for personal emergency response systems covered under Regulation .28 of this chapter may only be allowed for participants who:</text> <paragraph num="(1)"> <text>Are alone for significant parts of the day;</text> </paragraph> <paragraph num="(2)"> <text>Have no regular caregiver for extended parts of the day; and</text> </paragraph> <paragraph num="(3)"> <text>Would otherwise require extensive routine supervision to ensure the participant's health and safety.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Maryland Medical Assistance Program may not reimburse for attendant care services provided under this chapter if:</text> <paragraph num="(1)"> <text>On the same date of service, a participant also received personal care services under COMAR 10.09.20; or</text> </paragraph> <paragraph num="(2)"> <text>Rendered for more than 23 hours for a participant on the same date of service.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reimbursement for the following services shall be limited to 8 hours per service per date of service:</text> <paragraph num="(1)"> <text>Family training;</text> </paragraph> <paragraph num="(2)"> <text>Participant training; or</text> </paragraph> <paragraph num="(3)"> <text>Nursing supervision.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The total amount of reimbursement by the Maryland Medical Assistance Program for transition services is limited to a one-time expense of $3,000 per participant, with exceptions allowed at the Department's discretion.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Payment Procedures — General."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider shall:</text> <paragraph num="(a)"> <text>Submit a request for payment for the services covered under this chapter according to procedures set forth in COMAR 10.09.36.04; and</text> </paragraph> <paragraph num="(b)"> <text>Include the following information on the request:</text> <paragraph num="(i)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(ii)"> <text>Participant's name and Medical Assistance number;</text> </paragraph> <paragraph num="(iii)"> <text>Provider's name, location, and identification number;</text> </paragraph> <paragraph num="(iv)"> <text>Nature, procedure code or codes, and unit or units of the covered services provided; and</text> </paragraph> <paragraph num="(v)"> <text>Amount of reimbursement requested.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The provider shall submit a request for payment in a manner approved by the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(3)"> <text>Participant-employed attendants shall submit a request for payment to a designated fiscal intermediary who shall:</text> <paragraph num="(a)"> <text>Submit bills to the Department;</text> </paragraph> <paragraph num="(b)"> <text>Withhold appropriate taxes; and</text> </paragraph> <paragraph num="(c)"> <text>Remit reimbursement to the provider for services rendered.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A request for payment shall include all units of service rendered, as defined in Regulations .22 — .37 of this chapter, during a given time period for a participant.</text> </paragraph> <paragraph num="(5)"> <text>Except as specified in §A(3) of this regulation, the provider shall bill the Department, or its authorized agent, in accordance with the payment methodology specified in Regulation .41 of this chapter for services approved by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments for services rendered to a participant shall be made:</text> <paragraph num="(a)"> <text>Directly to a qualified provider; or</text> </paragraph> <paragraph num="(b)"> <text>To a designated fiscal intermediary for distribution to participant-employed attendants.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established in Regulation .41 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Payment by the Department for the services covered under this chapter:</text> <paragraph num="(a)"> <text>Shall be considered as payment in full; and</text> </paragraph> <paragraph num="(b)"> <text>May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The ICS Program’s rates as specified in Regulation .41A — C, E, I — M, O, and P of this chapter shall increase on July 1 of each year beginning July 1, 2012, subject to the limitations of the State budget, by the lesser of:</text> <paragraph num="(1)"> <text>2.5 percent; or</text> </paragraph> <paragraph num="(2)"> <text>The change from March to March in the medical care component of the Consumer Price Index for all urban consumers (CPI-U) for the Washington-Baltimore area.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Payment Procedures — Rates."> <paragraph num="A."> <text>To receive payment as a provider of services covered under Regulations .23, .24, and .33—.37 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual.</text> </paragraph> <paragraph num="B."> <text>Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="C."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rates established in §D of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Rates.</text> <paragraph num="(1)"> <text>For dates of service beginning July 1, 2024, fees per unit of service shall be as follows:</text> <paragraph num="(a)"> <text>Assisted Living Level II, No Medical Day Care—reimbursed at the maximum rate of $90.74 per day;</text> </paragraph> <paragraph num="(b)"> <text>Assisted Living Level III, No Medical Day Care—reimbursed at the maximum rate of $114.51 per day;</text> </paragraph> <paragraph num="(c)"> <text>Assisted Living Level II, Medical Day Care—reimbursed at the maximum rate of $68.09 per day;</text> </paragraph> <paragraph num="(d)"> <text>Assisted Living Level III, Medical Day Care—reimbursed at the maximum rate of $85.86 per day;</text> </paragraph> <paragraph num="(e)"> <text>Behavioral Consultation—reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(f)"> <text>Case Management—Administrative—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(g)"> <text>Case Management—Comprehensive—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(h)"> <text>Case Management—Ongoing—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit;</text> </paragraph> <paragraph num="(i)"> <text>Dietitian and Nutritionist Services—reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(j)"> <text>Family 1/1 Training—reimbursed at the maximum rate of $99.25 per hour;</text> </paragraph> <paragraph num="(k)"> <text>Medical Day Care Services—reimbursed at the maximum rate of $116.59 per day; and</text> </paragraph> <paragraph num="(l)"> <text>Senior Center Plus—reimbursed at the maximum rate of $72.19 per day.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The ICS Program’s rates for covered services under Regulations .23, .24, and .33—.37 of this chapter shall be adjusted subject to the limitations of the State budget.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".43" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".44" heading="Appeal Procedures for Providers."> <text>Appeal procedures for providers are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".45" heading="Appeal Procedures for Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04.</text> </regulation> <regulation prefix="Regulation" num=".46" heading="Interpretive Regulation."> <text>State regulations are interpreted as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 11, 2012 (39:11 Md. R. 687)</annotation> <annotation type="History" subtype="Administrative History">Regulation .40C amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41 amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41 repealed effective December 11, 2025 (52:23 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41 adopted effective December 11, 2025 (52:23 Md. R. 1198)</annotation> </annotations> </chapter> <chapter num="82" heading="Provider-Based Outpatient Oncology Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(2)"> <text>“Healthcare Common Procedure Coding System (HCPCS)” means a set of health care procedure codes based on the American Medical Association's Current Procedural Terminology (CPT).</text> </paragraph> <paragraph num="(3)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Medicare-certified facility” means a facility which is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS).</text> </paragraph> <paragraph num="(5)"> <text>“Provider-based outpatient oncology facility” means an outpatient facility that is:</text> <paragraph num="(a)"> <text>Owned by a hospital;</text> </paragraph> <paragraph num="(b)"> <text>Located off-site from the hospital; and</text> </paragraph> <paragraph num="(c)"> <text>Not regulated by the Health Services Cost Review Commission (HSCRC).</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <text>In order to participate in the Program, the provider shall:</text> <paragraph num="A."> <text>Meet all requirements as set forth in COMAR 10.09.36.02; and</text> </paragraph> <paragraph num="B."> <text>Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed and if located:</text> <paragraph num="(1)"> <text>In Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>To participate in the Program, a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation with the Department as a provider-based outpatient oncology facility require that the provider shall:</text> <paragraph num="(1)"> <text>Be a Medicare-certified facility;</text> </paragraph> <paragraph num="(2)"> <text>Have clearly defined, written patient care policies; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>A description of the service provided; and</text> </paragraph> <paragraph num="(c)"> <text>A legible signature and printed or typed name of the professional providing care, with the appropriate title.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the following services when medically necessary:</text> <paragraph num="A."> <text>Radiation therapy;</text> </paragraph> <paragraph num="B."> <text>Chemotherapy;</text> </paragraph> <paragraph num="C."> <text>IV Infusion;</text> </paragraph> <paragraph num="D."> <text>Blood transfusions;</text> </paragraph> <paragraph num="E."> <text>Medical supplies;</text> </paragraph> <paragraph num="F."> <text>Drugs; and</text> </paragraph> <paragraph num="G."> <text>Bone marrow biopsies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The following services are not covered:</text> <paragraph num="A."> <text>Any service or treatment that is not medically necessary;</text> </paragraph> <paragraph num="B."> <text>Experimental or investigational services;</text> </paragraph> <paragraph num="C."> <text>Services that are specifically included as part of another service; and</text> </paragraph> <paragraph num="D."> <text>Professional fees provided by physicians billed separately from the facility’s charges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>Specific Payment Procedures for a Provider-Based Outpatient Oncology Facility.</text> <paragraph num="(1)"> <text>The provider shall submit a request for payment on the form designated by the Department for dates of service on or after July 1, 2012.</text> </paragraph> <paragraph num="(2)"> <text>Except for drugs which shall be billed to the Program using the National Drug Code (NDC) and appropriate the HCPCS, the Department shall reimburse the facility at an amount that is equal to 80 percent of the Medicare rate of reimbursement.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall authorize payment on Medicare claims if:</text> <paragraph num="(a)"> <text>The provider accepts Medicare;</text> </paragraph> <paragraph num="(b)"> <text>Medicare makes direct payment to the provider; and</text> </paragraph> <paragraph num="(c)"> <text>Medicare has determined the services are medically necessary.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The provider may not bill the Program or the recipient for:</text> <paragraph num="(a)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(b)"> <text>Broken or missed appointments; or</text> </paragraph> <paragraph num="(c)"> <text>Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Program makes no direct payments to recipients.</text> </paragraph> <paragraph num="(6)"> <text>The billing time limitations are set forth in COMAR 10.09.36.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <text>General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 17, 2012 (39:18 Md. R. 1196)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> </annotations> </chapter> <chapter num="83" heading="Third Party Liability"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Claim” means a demand for payment, whether or not the right is reduced to judgment, liquidated, unliquidated, fixed, contingent, matured, unmatured, disputed, undisputed, legal, equitable, secured or unsecured.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(3)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(4)"> <text>“Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or certified to provide health care services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.</text> </paragraph> <paragraph num="(5)"> <text>“Recipient” means:</text> <paragraph num="(a)"> <text>An individual who is certified as eligible for, and is receiving, Program benefits;</text> </paragraph> <paragraph num="(b)"> <text>An individual who was certified as eligible for and received Program benefits; or</text> </paragraph> <paragraph num="(c)"> <text>The successor in interest of a person identified in §B(6)(a) or (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Third party” means any individual, entity or program that is or may be liable to pay all or part of the expenditures for Program benefits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Program’s Right of Subrogation."> <paragraph num="A."> <text>The Department may not pay medical claims that are payable by a third party.</text> </paragraph> <paragraph num="B."> <text>The Department is assigned any and all rights to payments by any third party that result from medical care received by the recipient, together with the rights of any other individuals eligible for Program benefits for whom the recipient can make assignment. This assignment shall be effective to the extent of the amount of medical assistance actually paid by the Program.</text> </paragraph> <paragraph num="C."> <text>If a recipient has a cause of action against a third party, including a claim under Insurance Article, §19-509 or 19-510, Annotated Code of Maryland, the Department shall be subrogated to that cause of action to the extent of any payments made by the Department on behalf of the recipient that result from the occurrence that gave rise to the cause of action.</text> </paragraph> <paragraph num="D."> <text>The Department’s subrogation claim shall be limited to that portion of the claim that represents compensation for the medical expenses paid by the Program until the date of an award, settlement or judgment.</text> </paragraph> <paragraph num="E."> <text>Judicial Allocation of Medical Expenses from an Award or Settlement.</text> <paragraph num="(1)"> <text>A recipient may not agree, in settlement of the recipient’s cause of action, to an allocation of medical expenses less than the amounts set forth in §F of this regulation, without prior approval of the Department.</text> </paragraph> <paragraph num="(2)"> <text>If an action decided by the court does not determine the allocation of medical expenses in such action, the allocation shall be determined in accordance with §F of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Provided that the Department is provided at least 10 days advance written notice of any hearing at which the allocation of medical expenses shall be heard, the Department shall defer to the court’s determination of the allocation of medical expenses.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department’s Recovery in Subrogation Claims.</text> <paragraph num="(1)"> <text>Except as provided in §§F(2) — (4) of this regulation, in satisfaction of the Department’s subrogation claim, the Department shall recover the lesser of:</text> <paragraph num="(a)"> <text>The full amount of past medical costs paid by the Program; or</text> </paragraph> <paragraph num="(b)"> <text>50 percent of the judgment, award or settlement less attorney fees, litigation costs, and other deductions required by law.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For the benefit of the recipient, the Department’s recovery in subrogation claims as provided in §F(1) of this regulation shall be reduced by one-third, for the amount of the attorney’s fees incurred by the recipient in bringing the case, unless the Department files a petition to intervene in a case in which it has a subrogation interest, is independently represented by counsel and has been provided the notice required by §E(3) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall provide the recipient written notice under COMAR 10.01.04.03 of the amount of the subrogation claim it proposes to recover as provided in §§F(1)—(2) of this regulation and of the recipient’s right to request a fair hearing to present evidence of a different allocation of medical expenses. If the recipient files a request for a hearing, the recipient shall bear the burden of proof and the hearing shall be governed by COMAR 10.01.04. Unless the recipient files a timely request for a hearing within 30 days of receipt of the written notice, the Department shall recover the amount of the subrogation claim set forth in the written notice to the recipient.</text> </paragraph> <paragraph num="(4)"> <text>If the amount of money actually collected by the recipient is less than the amount of the judgment or award because available insurance coverage is less than the amount of the judgment or award, the Department’s recovery as calculated in §F(1) of this regulation shall be proportionally reduced by the same percentage as is the amount actually collected compared to the amount of the judgment or award.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Unless ordered by a court, the Department may not be required to join, intervene, or otherwise become a party to the cause of action against a third party to maintain the Department’s subrogation right under §C of this regulation.</text> </paragraph> <paragraph num="H."> <text>An action brought under this regulation is not exclusive and is independent of and in addition to any right, remedy, or cause of action available to the State, the Department, other State agencies, or a Program recipient or other individual.</text> </paragraph> <paragraph num="I."> <text>The Department may enter into contracts for the collection of medical expenses already paid by the Program from potential third parties. The Department may pay, from the funds recovered by the contractor, amounts owed to the federal government as the Department’s share of the Program paid claim, and the costs of collecting the funds.</text> </paragraph> <paragraph num="J."> <text>The Department may assign the Department’s rights of subrogation to a managed care organization and shall provide notice of the assignment to the recipient or the recipient’s attorney.</text> </paragraph> <paragraph num="K."> <text>The Department may compromise or settle and release the Department’s subrogation claim if, in the Department’s judgment, collection of the claim will cause substantial hardship to the:</text> <paragraph num="(1)"> <text>Recipient; or</text> </paragraph> <paragraph num="(2)"> <text>Surviving dependents of a deceased recipient in a wrongful death action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Recipient Responsibility."> <paragraph num="A."> <text>A recipient shall cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program.</text> </paragraph> <paragraph num="B."> <text>A recipient is required to assist and cooperate fully with the Department in the Department’s efforts to secure the Department’s rights in Regulation .02 of this chapter, including but not limited to:</text> <paragraph num="(1)"> <text>Notifying the Program’s Division of Recoveries and Financial Services in writing within 10 days of filing suit or commencing an action against a third party;</text> </paragraph> <paragraph num="(2)"> <text>Notifying the Program’s Division of Recoveries and Financial Services in writing before negotiating or entering a settlement with a third party;</text> </paragraph> <paragraph num="(3)"> <text>Subject to Regulation .05 of this chapter, paying to the Program within 30 days all funds received from a third party to the extent necessary to satisfy the subrogation rights of the Department;</text> </paragraph> <paragraph num="(4)"> <text>Disclosing information regarding health insurance or other third party resources when applying for Program benefits;</text> </paragraph> <paragraph num="(5)"> <text>Notifying providers of health and casualty coverage and other third party resources when requesting medical care;</text> </paragraph> <paragraph num="(6)"> <text>Notifying the Program of any health insurance obtained after becoming eligible for Medicaid;</text> </paragraph> <paragraph num="(7)"> <text>Notifying the Program’s Division of Recoveries and Financial Services of any casualty or liability insurance that may cover medical treatment received due to an injury; and</text> </paragraph> <paragraph num="(8)"> <text>Executing and delivering to the Program such documents as reasonably requested by the Program to pursue the Department’s subrogation claim.</text> </paragraph> </paragraph> <paragraph num="C."> <text>As a condition of medical assistance eligibility, a person who applies for Program benefits shall, at the time of application:</text> <paragraph num="(1)"> <text>Assign to the Department the applicant's rights of payment for care and services from a third party to the extent the Department has paid for care and services;</text> </paragraph> <paragraph num="(2)"> <text>Cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program; and</text> </paragraph> <paragraph num="(3)"> <text>Agree to apply for all other available third party resources that may be used to:</text> <paragraph num="(a)"> <text>Provide or pay for the cost of care or services received by the recipient; or</text> </paragraph> <paragraph num="(b)"> <text>Finance reimbursement to the State for the cost of care or services received by the recipient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Nothing in this regulation shall require a recipient to file a civil or other action for the purpose of reimbursing the State for the cost of care or services. If a recipient fails or refuses to commence a civil or other action to enforce the legal liability of a third party, the Department may commence an independent action, after notice to the recipient, to recover all medical costs to which the Department is entitled. In any such action by the Department, the recipient in interest may be joined as a party.</text> </paragraph> <paragraph num="E."> <text>Failure of the applicant or recipient to cooperate with the Program to secure the Department’s rights to subrogation and assignment may result in the denial or termination of the recipient’s Program eligibility. Recipients terminated under this regulation shall be notified in writing of the proposed Program action and afforded the opportunity for a fair hearing under COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Notice to the Department."> <paragraph num="A."> <text>An attorney representing a recipient in a cause of action that gives rise to the Department’s right of subrogation under Regulation .02 of this chapter shall notify the Program’s Division of Recoveries and Financial Services in writing before:</text> <paragraph num="(1)"> <text>Filing a claim;</text> </paragraph> <paragraph num="(2)"> <text>Commencing an action; or</text> </paragraph> <paragraph num="(3)"> <text>Negotiating a settlement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The notice required under §A of this regulation shall include submission of the following information:</text> <paragraph num="(1)"> <text>The recipient's name, Social Security Number, date of birth, last known address, and telephone number;</text> </paragraph> <paragraph num="(2)"> <text>The name of any person against whom the recipient is making a claim;</text> </paragraph> <paragraph num="(3)"> <text>The identification of each potentially liable third party, including that party's name, last known address, and telephone number;</text> </paragraph> <paragraph num="(4)"> <text>The name of any insurer of any person against whom the recipient is making a claim, if known;</text> </paragraph> <paragraph num="(5)"> <text>The date of the injury or illness giving rise to the claim;</text> </paragraph> <paragraph num="(6)"> <text>A short statement identifying the nature of the recipient’s claim or the terms of any settlement, judgment or award;</text> </paragraph> <paragraph num="(7)"> <text>Copies of the pleadings and other papers related to the action or claim; and</text> </paragraph> <paragraph num="(8)"> <text>A valid release of the confidentiality of the recipient’s medical records from the date of the injury until the date of the notice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In any action or claim by a recipient to recover damages for an injury or illness that has resulted in the Department providing or paying for Program benefits, an attorney who represents a recipient shall give the Program’s Division of Recoveries and Financial Services written notice:</text> <paragraph num="(1)"> <text>Not later than 30 calendar days after any judgment or award in such action or claim; or</text> </paragraph> <paragraph num="(2)"> <text>Before the resolution of the cause of action or claim.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the notices required in §§A and C of this regulation, an attorney required to give notice under §A or C of this regulation shall give the Program’s Division of Recoveries and Financial Services additional written notice not later than 30 calendar days after judgment, award, or settlement of the action or claim stating the amount and terms of any judgment, award, or settlement of the action or claim.</text> </paragraph> <paragraph num="E."> <text>Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, acknowledge in writing its claim to the recipient or the attorney of the recipient and to the third party. The Department shall provide the amount of the claim and an itemized list of charges within 15 business days pursuant to Regulation .06 of this chapter. Nothing herein shall prevent the Department from thereafter updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges.</text> </paragraph> <paragraph num="F."> <text>Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, advise the recipient or the attorney of the recipient and the third party, in writing, whether the recipient is:</text> <paragraph num="(1)"> <text>A Medicaid recipient;</text> </paragraph> <paragraph num="(2)"> <text>A member of a Medicaid Managed Care Organization (MCO); or</text> </paragraph> <paragraph num="(3)"> <text>Not a Medicaid recipient.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Under Regulation .06 of this chapter, the Department shall provide the amount of the claim and an itemized list of charges within 15 business days of receipt of the notice required under §A of this regulation. Nothing in this regulation shall prevent the Department from updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Judgment, Award, or Settlement of a Medical Assistance Claim."> <paragraph num="A."> <text>Except as provided in §§B—E of this regulation, a third party shall have no further liability if it settles or compromises a dispute in good faith and without knowledge that the individual is a recipient of Program benefits.</text> </paragraph> <paragraph num="B."> <text>A recipient, or the recipient’s attorney, guardian, or personal representative, who receives money as a result of a judgment, award, or settlement of an action or claim in which the Department has a subrogation claim shall:</text> <paragraph num="(1)"> <text>Deduct applicable attorney fees and litigation costs from the total judgment, award, or settlement;</text> </paragraph> <paragraph num="(2)"> <text>Subject to §C of this regulation, hold and forward to the Department the remainder of the judgment, award, or settlement for the benefit of the Department to the extent required for the Department’s subrogation claim.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A recipient shall first repay the Department for costs of past Program services provided to the recipient related to that action or claim before placing any money received from a judgment, award, or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distributing the recovered funds to or for the benefit of the recipient. If the recipient and the Department disagree about the amount of the Department’s subrogation right under Regulation .02 of this chapter, the recipient may place the undisputed portion of the judgment, award or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distribute the undisputed portion to or for the benefit of the recipient, and the disputed portion of the judgment, award or settlement into an escrow account pending resolution of the disagreement.</text> </paragraph> <paragraph num="D."> <text>The Department may only discharge a claim under Regulation .06 of this chapter if the discharge complies with federal law.</text> </paragraph> <paragraph num="E."> <text>Liability to the Department.</text> <paragraph num="(1)"> <text>Except as otherwise provided in §E(3) of this regulation, a person who, after written notice of the Department’s subrogation claim under Regulation .04F of this chapter, disposes of money as a result of a judgment, award, or settlement of an action or claim in violation of §B or C of this regulation, without the written approval of the Department, shall be liable to the Department for any amount that, because of the disposition, is not recoverable by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Except as otherwise provided in §E(3) of this regulation, any person who fails to comply with the notice requirements of Regulation .04 of this chapter is liable to the Department for:</text> <paragraph num="(a)"> <text>The total amount of the Department’s claim created pursuant to Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Any attorney’s fees and litigation expenses incurred by the Department in enforcing the Department’s subrogation rights.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A person is not liable to the Department under §E(1) or (2) of this regulation if a court determines that there was good cause for:</text> <paragraph num="(a)"> <text>Disposing of the money in violation of §B or C of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Failing to comply with the notice requirements of Regulation .04 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Program Claim."> <paragraph num="A."> <text>In a case where the Department is subrogated to the rights of the recipient, the Department has a claim to the proceeds of the recovery from the persons liable, whether the proceeds of the recovery are by way of judgment, settlement, or otherwise and shall, to the extent permitted by federal law, be satisfied in full.</text> </paragraph> <paragraph num="B."> <text>The claim is in the amount of all Program benefits paid minus any deductions required by law.</text> </paragraph> <paragraph num="C."> <text>The claim is effective when:</text> <paragraph num="(1)"> <text>Filed with a court of competent jurisdiction in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Notice of filing of the claim is served by the Department upon the third party, personally or by registered, certified, or insured mail, return receipt requested.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Conflict with Federal Requirements."> <text>If any provision of this chapter related to subrogation, assignment, or lien conflicts with federal law concerning the Program or receipt of federal funds to finance the Program, the provision does not apply to the extent of the conflict.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-120—15-121.3, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 24, 2013 (40:12 Md. R. 1042)</annotation> </annotations> </chapter> <chapter num="84" heading="Community First Choice"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of Community First Choice is to provide certain home and community-based services and supports, as an alternative to institutional placements, to individuals who have been determined to require an institutional level of care.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living (ADLs)” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Bathing and completing personal hygiene routines;</text> </paragraph> <paragraph num="(b)"> <text>Dressing and changing clothes;</text> </paragraph> <paragraph num="(c)"> <text>Eating;</text> </paragraph> <paragraph num="(d)"> <text>Mobility, including:</text> <paragraph num="(i)"> <text>Transferring from a bed, chair, or other structure;</text> </paragraph> <paragraph num="(ii)"> <text>Moving, turning, and positioning the body while in bed or in a wheelchair; and</text> </paragraph> <paragraph num="(iii)"> <text>Moving about indoors or outdoors; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Toileting, including:</text> <paragraph num="(i)"> <text>Bladder and bowel requirements;</text> </paragraph> <paragraph num="(ii)"> <text>Routines associated with the achievement or maintenance of continence; and</text> </paragraph> <paragraph num="(iii)"> <text>Incontinence care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who is applying to receive services under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Assistance” means that another individual:</text> <paragraph num="(a)"> <text>Physically performs the activity for the participant;</text> </paragraph> <paragraph num="(b)"> <text>Physically helps the participant to perform the activity;</text> </paragraph> <paragraph num="(c)"> <text>Monitors the participant’s performance of the activity in order to ensure health and safety; or</text> </paragraph> <paragraph num="(d)"> <text>Cues or encourages the participant to perform the activity.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Case management services” means services which assist an applicant or a participant in gaining access to waiver and other covered Medicaid services.</text> </paragraph> <paragraph num="(5)"> <text>“Case manager” means a person performing case management services under a waiver program and acting in the role of the supports planner.</text> </paragraph> <paragraph num="(6)"> <text>“Certified medication technician (CMT)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Completes a course in medication administration approved by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(b)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and</text> </paragraph> <paragraph num="(c)"> <text>Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who:</text> <paragraph num="(a)"> <text>Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and</text> </paragraph> <paragraph num="(b)"> <text>Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Community First Choice” means the Medicaid home and community-based services program implemented under this chapter in accordance with the application and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the provision of certain home and community-based services under the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(9)"> <text>Community Setting.</text> <paragraph num="(a)"> <text>“Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to:</text> <paragraph num="(i)"> <text>Seek employment and work in competitive integrated settings;</text> </paragraph> <paragraph num="(ii)"> <text>Engage in community life;</text> </paragraph> <paragraph num="(iii)"> <text>Control personal resources; and</text> </paragraph> <paragraph num="(iv)"> <text>Receive services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Community setting” does not mean:</text> <paragraph num="(i)"> <text>Hospitals;</text> </paragraph> <paragraph num="(ii)"> <text>Nursing facilities;</text> </paragraph> <paragraph num="(iii)"> <text>Institutions for mental diseases;</text> </paragraph> <paragraph num="(iv)"> <text>Intermediate care facilities for individuals with intellectual disabilities; or</text> </paragraph> <paragraph num="(v)"> <text>Other institutions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties.</text> </paragraph> <paragraph num="(11)"> <text>“Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a:</text> <paragraph num="(a)"> <text>Registered nurse in accordance with COMAR 10.27.11; or</text> </paragraph> <paragraph num="(b)"> <text>Nurse practitioner in accordance with COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department.</text> </paragraph> <paragraph num="(13)"> <text>Home.</text> <paragraph num="(a)"> <text>“Home” means the participant’s place of residence in a community setting.</text> </paragraph> <paragraph num="(b)"> <text>“Home” does not mean:</text> <paragraph num="(i)"> <text>An assisted living program as defined in COMAR 10.07.14;</text> </paragraph> <paragraph num="(ii)"> <text>A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07;</text> </paragraph> <paragraph num="(iii)"> <text>An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01;</text> </paragraph> <paragraph num="(iv)"> <text>Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or</text> </paragraph> <paragraph num="(v)"> <text>Any other provider-owned or controlled residence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor.</text> </paragraph> <paragraph num="(15)"> <text>“Instrumental activities of daily living” means tasks or activities that include, but are not limited to:</text> <paragraph num="(a)"> <text>Preparing meals;</text> </paragraph> <paragraph num="(b)"> <text>Performing light chores that are incidental to the personal assistance services provided to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries;</text> </paragraph> <paragraph num="(d)"> <text>Nutritional planning;</text> </paragraph> <paragraph num="(e)"> <text>Traveling as needed;</text> </paragraph> <paragraph num="(f)"> <text>Managing finances and handling money;</text> </paragraph> <paragraph num="(g)"> <text>Using the telephone or other appropriate means of communication;</text> </paragraph> <paragraph num="(h)"> <text>Reading; and</text> </paragraph> <paragraph num="(i)"> <text>Planning and making decisions.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants.</text> </paragraph> <paragraph num="(17)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01.</text> </paragraph> <paragraph num="(19)"> <text>“Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care.</text> </paragraph> <paragraph num="(20)"> <text>“Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10.</text> </paragraph> <paragraph num="(21)"> <text>“Participant” means an individual who:</text> <paragraph num="(a)"> <text>Has been determined to meet the qualifications for participation in Community First Choice as specified in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is enrolled with the Department to receive Medicaid services.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Personal assistance provider agency” means a public or private agency that:</text> <paragraph num="(a)"> <text>Employs or contracts with personal assistance workers; and</text> </paragraph> <paragraph num="(b)"> <text>Has been enrolled by the Program as a provider of personal assistance services.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>Personal Assistance Services.</text> <paragraph num="(a)"> <text>“Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability.</text> </paragraph> <paragraph num="(b)"> <text>“Personal assistance services” includes:</text> <paragraph num="(i)"> <text>Assistance with activities of daily living and instrumental activities of daily living; and</text> </paragraph> <paragraph num="(ii)"> <text>The performance of delegated nursing function.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Plan of service” means the written support plan that:</text> <paragraph num="(a)"> <text>Reflects what is important to the individual and what is important for his or her welfare; and</text> </paragraph> <paragraph num="(b)"> <text>Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Preauthorized” means approved by the Department or its designee before services can be rendered.</text> </paragraph> <paragraph num="(26)"> <text>“Program” means the Maryland Medicaid Program.</text> </paragraph> <paragraph num="(27)"> <text>“Provider” has the same meaning as defined in COMAR 10.09.36.</text> </paragraph> <paragraph num="(28)"> <text>“Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter.</text> </paragraph> <paragraph num="(29)"> <text>“Quality plan” means the plan developed by the Department to address quality assurance and oversight.</text> </paragraph> <paragraph num="(30)"> <text>“Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant.</text> </paragraph> <paragraph num="(31)"> <text>“Representative” means:</text> <paragraph num="(a)"> <text>The person authorized by the individual to serve as a representative in connection with the provision of Community First Choice services and supports;</text> </paragraph> <paragraph num="(b)"> <text>The individual who signs the plan of service on the participant’s behalf;</text> </paragraph> <paragraph num="(c)"> <text>Any individual who makes decisions on behalf of the participant related to the participant’s plan of service;</text> </paragraph> <paragraph num="(d)"> <text>A legal guardian of the individual for the participant; or</text> </paragraph> <paragraph num="(e)"> <text>The parent or foster parent of a dependent minor child.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Supports planner” means an individual who coordinates services, including:</text> <paragraph num="(a)"> <text>Supporting development of a plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and</text> </paragraph> <paragraph num="(c)"> <text>Ensuring an accurate plan of service is provided to the Department.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Telephonic timekeeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant.</text> </paragraph> <paragraph num="(34)"> <text>“Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Provider Licensing or Certification."> <text>The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered:</text> <paragraph num="A."> <text>Physicians;</text> </paragraph> <paragraph num="B."> <text>Registered nurses;</text> </paragraph> <paragraph num="C."> <text>Licensed practical nurses;</text> </paragraph> <paragraph num="D."> <text>Certified medication technicians;</text> </paragraph> <paragraph num="E."> <text>Certified nursing assistants;</text> </paragraph> <paragraph num="F."> <text>Occupational therapists;</text> </paragraph> <paragraph num="G."> <text>Physical therapists;</text> </paragraph> <paragraph num="H."> <text>Speech pathologists;</text> </paragraph> <paragraph num="I."> <text>Nutritionists; and</text> </paragraph> <paragraph num="J."> <text>Dietitians.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participant Eligibility."> <paragraph num="A."> <text>To participate in the Program, a participant shall:</text> <paragraph num="(1)"> <text>Be determined by the Department to need the level of care provided in a hospital, nursing facility, an intermediate care facility for individuals with intellectual disabilities, an institution providing psychiatric services for individuals younger than 21 years old, or an institution for mental diseases for individuals 65 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Be eligible for Medicaid under an eligibility group defined in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and</text> </paragraph> <paragraph num="(3)"> <text>Reside at home.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To be eligible for participation, a participant shall have an active plan of service. The plan of service shall:</text> <paragraph num="(1)"> <text>Be based on:</text> <paragraph num="(a)"> <text>The evaluation and recommended plan of care; and</text> </paragraph> <paragraph num="(b)"> <text>Consultation with the applicant or participant;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Address the applicant’s or participant’s health and safety needs;</text> </paragraph> <paragraph num="(3)"> <text>Specify the items and services needed to safely support the participant in the community, including:</text> <paragraph num="(a)"> <text>A plan for receiving personal assistance services in case of an emergency; and</text> </paragraph> <paragraph num="(b)"> <text>Specific requests for items or services that substitute for human assistance;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Specify the provider agency providing personal assistance services; and</text> </paragraph> <paragraph num="(5)"> <text>Include the signature of the:</text> <paragraph num="(a)"> <text>Participant or, when applicable, the individual’s representative;</text> </paragraph> <paragraph num="(b)"> <text>Supports planner; and</text> </paragraph> <paragraph num="(c)"> <text>Personal assistance provider agency listed within the plan of service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs.</text> </paragraph> <paragraph num="D."> <text>Participant eligibility shall be terminated if the participant:</text> <paragraph num="(1)"> <text>No longer meets the required level of care;</text> </paragraph> <paragraph num="(2)"> <text>No longer resides at home;</text> </paragraph> <paragraph num="(3)"> <text>Is without services for 30 consecutive calendar days;</text> </paragraph> <paragraph num="(4)"> <text>Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program;</text> </paragraph> <paragraph num="(5)"> <text>Moves to another state;</text> </paragraph> <paragraph num="(6)"> <text>Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or</text> </paragraph> <paragraph num="(7)"> <text>Dies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conditions for Provider Participation — General Requirements."> <paragraph num="A."> <text>To participate as a provider of a service covered under this chapter, a provider:</text> <paragraph num="(1)"> <text>Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall obtain written verification of the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request;</text> </paragraph> <paragraph num="(3)"> <text>Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by:</text> <paragraph num="(a)"> <text>Reporting incidents and complaints within 24 hours of knowledge of the event;</text> </paragraph> <paragraph num="(b)"> <text>Submitting a written report within 7 calendar days on a form designated by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents;</text> </paragraph> <paragraph num="(5)"> <text>Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been:</text> <paragraph num="(a)"> <text>Preauthorized in the participant’s plan of service;</text> </paragraph> <paragraph num="(b)"> <text>Provided in a manner consistent with the participant’s plan of service; and</text> </paragraph> <paragraph num="(c)"> <text>Identified in the provider agreement as within the scope of the provider’s Medicaid participation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative;</text> </paragraph> <paragraph num="(8)"> <text>Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services;</text> </paragraph> <paragraph num="(9)"> <text>Shall verify Medicaid eligibility at the beginning of each month that services will be rendered;</text> </paragraph> <paragraph num="(10)"> <text>May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and</text> </paragraph> <paragraph num="(11)"> <text>Shall be free from conflicts of interest.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have:</text> <paragraph num="(1)"> <text>Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker;</text> </paragraph> <paragraph num="(2)"> <text>Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.20;</text> </paragraph> <paragraph num="(3)"> <text>Undergone the imposition of sanctions under COMAR 10.09.36.08;</text> </paragraph> <paragraph num="(4)"> <text>Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency;</text> </paragraph> <paragraph num="(5)"> <text>Been cited by a State agency for deficiencies which affect participants’ health and safety; or</text> </paragraph> <paragraph num="(6)"> <text>Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to:</text> <paragraph num="(a)"> <text>Failure to meet contractual obligations; or</text> </paragraph> <paragraph num="(b)"> <text>Fraudulent billing practices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider who renders health-related services to participants shall agree to:</text> <paragraph num="(1)"> <text>Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Share and discuss the documented information at the request of the participant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for Provider Participation — Personal Assistance."> <paragraph num="A."> <text>Personal assistance service providers shall:</text> <paragraph num="(1)"> <text>Be licensed as a Residential Service Agency under COMAR 10.07.05 to provide Level Two or Level Three home care services;</text> </paragraph> <paragraph num="(2)"> <text>Employ a registered nurse who shall:</text> <paragraph num="(a)"> <text>Assess each new participant who requires personal assistance services;</text> </paragraph> <paragraph num="(b)"> <text>Participate in developing the worker instructions and in assigning appropriate personnel;</text> </paragraph> <paragraph num="(c)"> <text>Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and</text> </paragraph> <paragraph num="(d)"> <text>Participate in instructing the workers who will provide the assistance, when indicated;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following:</text> <paragraph num="(a)"> <text>The participant or, when applicable, the participant’s representative;</text> </paragraph> <paragraph num="(b)"> <text>The nurse monitor;</text> </paragraph> <paragraph num="(c)"> <text>A treating physician or nurse practitioner; or</text> </paragraph> <paragraph num="(d)"> <text>An individual from the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Allow participants to have a significant role in the delivery of their specific care including:</text> <paragraph num="(a)"> <text>Directing the services and supports identified in their plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Exercising as much control as desired to select, train, schedule, determine duties, and dismiss the personal assistance worker in their home;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Notify the Department in writing at least 45 days in advance of any:</text> <paragraph num="(a)"> <text>Voluntary closure;</text> </paragraph> <paragraph num="(b)"> <text>Change of ownership;</text> </paragraph> <paragraph num="(c)"> <text>Change of location;</text> </paragraph> <paragraph num="(d)"> <text>Sale of the business;</text> </paragraph> <paragraph num="(e)"> <text>Change in the name under which the provider is doing business; or</text> </paragraph> <paragraph num="(f)"> <text>Change in provider tax identification number;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business;</text> </paragraph> <paragraph num="(7)"> <text>Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants;</text> </paragraph> <paragraph num="(8)"> <text>If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services;</text> </paragraph> <paragraph num="(9)"> <text>Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program;</text> </paragraph> <paragraph num="(10)"> <text>At least monthly, collect and maintain the participant’s signature, or that of the participant’s representative when applicable, verifying services rendered; and</text> </paragraph> <paragraph num="(11)"> <text>Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall:</text> <paragraph num="(1)"> <text>If required to administer medications in accordance with the plan of service, be a certified medications technician; and</text> </paragraph> <paragraph num="(2)"> <text>If performing other delegated nursing functions, also be a certified nursing assistant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A personal assistance provider agency may not assign the participant’s representative to provide services to that participant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for Provider Participation — Supports Planning."> <text>To participate in the Program as a supports planning provider under Regulation .15 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Agree to be monitored by the Department; and</text> </paragraph> <paragraph num="B."> <text>Be:</text> <paragraph num="(1)"> <text>Identified by the Department through a solicitation process; or</text> </paragraph> <paragraph num="(2)"> <text>The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for Provider Participation — Consumer Training."> <text>To participate in the Program as a provider of consumer training under Regulation .16 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be a self-employed trainer or an agency that employs qualified trainers in accordance with §B of this regulation;</text> </paragraph> <paragraph num="B."> <text>Have demonstrated experience with the skill being taught; and</text> </paragraph> <paragraph num="C."> <text>Be willing to meet at the participant’s home to provide services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Specific Conditions for Provider Participation — Personal Emergency Response Systems."> <text>To participate in the Program as a provider of personal emergency response systems under Regulation .17 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be the store, vendor, organization, or company which sells, rents, installs, services, or operates the device or service;</text> </paragraph> <paragraph num="B."> <text>Provide or arrange for any installation, maintenance, training, or monitoring required for the device or system;</text> </paragraph> <paragraph num="C."> <text>Ensure that any response center is:</text> <paragraph num="(1)"> <text>Responsible for monitoring and responding to a notification of an emergency by the system; and</text> </paragraph> <paragraph num="(2)"> <text>Adequately staffed 24 hours a day, 7 days a week by properly trained staff; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Submit reports to the Department regarding activation and participant use no less than monthly or at a greater frequency as requested by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Specific Conditions for Provider Participation — Items or Services that Substitute for Human Assistance."> <paragraph num="A."> <text>To participate in the program as a provider of items or services that substitute for human assistance, the provider shall:</text> <paragraph num="(1)"> <text>Be approved and monitored by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Provide or arrange for any installation, maintenance, training, or monitoring required for the proper operation of the device or system, if applicable; and</text> </paragraph> <paragraph num="(3)"> <text>Receive a referral from the participant, participant’s case manager, or supports planner, based on services preauthorized in the plan of service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To participate in the Program as a provider of home-delivered meals, the provider shall:</text> <paragraph num="(1)"> <text>Use a cooking facility or food preparation site that has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and</text> </paragraph> <paragraph num="(2)"> <text>Be approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To participate in the Program as a provider of assistive devices, equipment, or technology services, the provider shall be one of the following entities:</text> <paragraph num="(1)"> <text>A Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12; or</text> </paragraph> <paragraph num="(2)"> <text>The store, vendor, organization, or company which sells or rents the equipment or system, subject to Department approval.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To participate as a provider of accessibility adaptations a provider shall:</text> <paragraph num="(1)"> <text>Have a current license with the Maryland Home Improvement Commission; and</text> </paragraph> <paragraph num="(2)"> <text>Be approved by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Specific Conditions for Provider Participation — Environmental Assessments."> <text>To participate in the Program as a provider of environmental assessments under Regulation .19 of this chapter, the provider shall:</text> <paragraph num="A."> <text>Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist;</text> </paragraph> <paragraph num="B."> <text>Receive a referral from the participant’s supports planner, based on services preauthorized in the plan of service; and</text> </paragraph> <paragraph num="C."> <text>Document the provider’s findings and recommendations on a form approved by the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Specific Conditions for Provider Participation — Nurse Monitoring."> <text>To participate in the Program as a nurse monitoring provider under Regulation .20 of this chapter, a provider shall:</text> <paragraph num="A."> <text>Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act;</text> </paragraph> <paragraph num="B."> <text>Employ or contract with registered nurses who hold a current professional license to practice in Maryland;</text> </paragraph> <paragraph num="C."> <text>Agree to accept all referrals from the Department; and</text> </paragraph> <paragraph num="D."> <text>Agree to be monitored by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Covered Services — General."> <text>The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .24 of this chapter, and documented as necessary to prevent institutionalization.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Covered Services — Personal Assistance."> <paragraph num="A."> <text>The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting.</text> </paragraph> <paragraph num="B."> <text>The Program covers the following services when provided by a personal assistance provider:</text> <paragraph num="(1)"> <text>Assistance with activities of daily living;</text> </paragraph> <paragraph num="(2)"> <text>Delegated nursing functions if this assistance is:</text> <paragraph num="(a)"> <text>Specified in the participant’s plan of service; and</text> </paragraph> <paragraph num="(b)"> <text>Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assistance with tasks requiring judgment to protect a participant from harm or neglect;</text> </paragraph> <paragraph num="(4)"> <text>Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Personal assistance services may not include:</text> <paragraph num="(1)"> <text>Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant;</text> </paragraph> <paragraph num="(2)"> <text>The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or</text> </paragraph> <paragraph num="(3)"> <text>Housekeeping services, other than those incidental to services covered under §B of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Covered Services — Supports Planning."> <paragraph num="A."> <text>Supports planning services shall:</text> <paragraph num="(1)"> <text>Address the individualized needs of the participant;</text> </paragraph> <paragraph num="(2)"> <text>Be sensitive to the educational background, culture, and general environment of the participant;</text> </paragraph> <paragraph num="(3)"> <text>Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties, and dismiss the personal assistance worker; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure freedom of choice among any willing provider for all services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supports planning services include the following activities:</text> <paragraph num="(1)"> <text>Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant;</text> </paragraph> <paragraph num="(2)"> <text>Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to:</text> <paragraph num="(a)"> <text>Behavioral health;</text> </paragraph> <paragraph num="(b)"> <text>Educational services;</text> </paragraph> <paragraph num="(c)"> <text>Disposable medical supplies and durable medical equipment;</text> </paragraph> <paragraph num="(d)"> <text>Housing;</text> </paragraph> <paragraph num="(e)"> <text>Medical services; and</text> </paragraph> <paragraph num="(f)"> <text>Social services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitoring the provision of services to determine if services are received in accordance with the plan of service;</text> </paragraph> <paragraph num="(4)"> <text>Using information technology systems developed by the Department;</text> </paragraph> <paragraph num="(5)"> <text>Coordinating with the fiscal intermediary to assist in managing budgeted resources;</text> </paragraph> <paragraph num="(6)"> <text>Providing guidance and support to help individuals self-direct their services; and</text> </paragraph> <paragraph num="(7)"> <text>Administering funds for transition services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Covered Services — Consumer Training."> <paragraph num="A."> <text>Consumer training includes instruction and skill building in such areas including, but not limited to, acquisition, maintenance, and enhancement of skills necessary for the participant to accomplish ADLs and IADLs.</text> </paragraph> <paragraph num="B."> <text>The topics covered by consumer training shall be:</text> <paragraph num="(1)"> <text>Targeted to the individualized needs of the participant receiving the training; and</text> </paragraph> <paragraph num="(2)"> <text>Sensitive of the educational background, culture, and general environment of the participant receiving the training.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Consumer training does not include time spent by the provider:</text> <paragraph num="(1)"> <text>Planning, preparing, or setting up the training; or</text> </paragraph> <paragraph num="(2)"> <text>Following up after the training.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Covered Services — Personal Emergency Response Systems."> <paragraph num="A."> <text>The Program covers the following related to a device, system, or piece of equipment described under §B of this regulation:</text> <paragraph num="(1)"> <text>Purchase and installation;</text> </paragraph> <paragraph num="(2)"> <text>Monthly cost of a covered system or rented device or equipment, including monitoring, maintenance, and repair.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include but is not limited to:</text> <paragraph num="(1)"> <text>A device connected to the participant’s telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>A portable help button to allow for the participant’s mobility; and</text> </paragraph> <paragraph num="(3)"> <text>A motion detector when necessary for the participant’s safety.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Covered Services — Items or Services that Substitute for Human Assistance."> <paragraph num="A."> <text>The program covers items or services that increase a participant’s independence or substitute for human assistance, to the extent that expenditures would otherwise be made for the human assistance.</text> </paragraph> <paragraph num="B."> <text>Each item or service shall:</text> <paragraph num="(1)"> <text>Be preauthorized in the participant’s plan of service as necessary to:</text> <paragraph num="(a)"> <text>Prevent the participant’s institutionalization; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure the participant’s health, safety, and independence;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Specifically relate to ADLs or IADLs within the approved plan of service;</text> </paragraph> <paragraph num="(3)"> <text>Comply with policies and procedure guidance defined by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Meet necessary standards of manufacture, design, usage, and installation, if applicable;</text> </paragraph> <paragraph num="(5)"> <text>Be provided in accordance with applicable State and local building codes and pass required inspections, if applicable; and</text> </paragraph> <paragraph num="(6)"> <text>Not be prescribed primarily to provide comfort or convenience.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each item or service shall be confirmed by the Program as not covered for the participant by:</text> <paragraph num="(1)"> <text>Medicaid under the State Plan as durable medical equipment or pharmacy services under COMAR 10.09.03, 10.09.12, or 10.09.67;</text> </paragraph> <paragraph num="(2)"> <text>Medicare; or</text> </paragraph> <paragraph num="(3)"> <text>Any other third-party payer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program covers home-delivered meals provided during meal periods that personal assistance services are not provided. Home-delivered meals shall be:</text> <paragraph num="(1)"> <text>Delivered to the participant’s home;</text> </paragraph> <paragraph num="(2)"> <text>Intended for consumption at home;</text> </paragraph> <paragraph num="(3)"> <text>Nutritionally adequate for the participant’s age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council and demonstrated by having the menus certified in writing by a physician, dietitian, or nutritionist; and</text> </paragraph> <paragraph num="(4)"> <text>At least one-third of the RDA, DRI, or therapeutic diet requirements ordered by the participant’s physician, dietitian, or nutritionist, including any ordered nutritional supplements.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Technology that substitutes for human assistance includes:</text> <paragraph num="(1)"> <text>Environmental controls for the home or automobile;</text> </paragraph> <paragraph num="(2)"> <text>Personal computers, software, or accessories;</text> </paragraph> <paragraph num="(3)"> <text>Augmentative communication devices;</text> </paragraph> <paragraph num="(4)"> <text>Maintenance or repair of technology devices;</text> </paragraph> <paragraph num="(5)"> <text>Self-help aids that assist with activities of daily living or instrumental activities of daily living; and</text> </paragraph> <paragraph num="(6)"> <text>Assessments and training in the use of assistive technology.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Covered Services — Environmental Assessments and Adaptations."> <paragraph num="A."> <text>The Program covers an on-site environmental assessment and adaptations of a home or residence where the participant lives or will live as a participant.</text> </paragraph> <paragraph num="B."> <text>An environmental assessment or adaptation may not be provided before the effective date of the participant’s enrollment in services.</text> </paragraph> <paragraph num="C."> <text>The environmental assessment may be recommended by a multidisciplinary team in the plan of service for a participant when an environmental assessment is considered necessary to:</text> <paragraph num="(1)"> <text>Ensure the health and safety of a participant with special environmental needs; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain additional professional advice from an occupational therapist about the:</text> <paragraph num="(a)"> <text>Physical structure of a participant’s home or residence; and</text> </paragraph> <paragraph num="(b)"> <text>Functional or mental limitations or disabilities of a participant as they relate to the environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Included in the environmental assessment, as necessary, may be:</text> <paragraph num="(1)"> <text>An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant;</text> </paragraph> <paragraph num="(2)"> <text>Environmental factors in the facility or home;</text> </paragraph> <paragraph num="(3)"> <text>The participant’s ability to perform activities of daily living;</text> </paragraph> <paragraph num="(4)"> <text>The participant’s strength, range of motion, and endurance; and</text> </paragraph> <paragraph num="(5)"> <text>The participant’s need for assistive devices and equipment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Based on an inspection of the home and interviews with the participant and any individual requested by the participant, the provider shall complete a form, to be reviewed by the supports planner, which details the provider’s findings and recommendations, especially relating to a participant’s need for services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Covered Services — Nurse Monitoring."> <paragraph num="A."> <text>The program covers the following services when provided by a nurse monitor:</text> <paragraph num="(1)"> <text>Being available to give instruction and to answer questions;</text> </paragraph> <paragraph num="(2)"> <text>Complying with the Department’s reportable events policy; and</text> </paragraph> <paragraph num="(3)"> <text>Maintaining an up-to-date client profile in an electronic database designated by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers nurse monitoring services according to the following schedule:</text> <paragraph num="(1)"> <text>Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and</text> </paragraph> <paragraph num="(2)"> <text>Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Home and Workplace Visits.</text> <paragraph num="(1)"> <text>The nurse monitoring provider shall use the home or workplace visit for the following purposes:</text> <paragraph num="(a)"> <text>To assess the participant’s condition;</text> </paragraph> <paragraph num="(b)"> <text>To assess the quality of personal assistance services; and</text> </paragraph> <paragraph num="(c)"> <text>To determine the need for discharge from personal assistance services or referral to other services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nurse monitor shall assess the quality of personal assistance services by:</text> <paragraph num="(a)"> <text>Reviewing documentation related to the provision of personal assistance services; and</text> </paragraph> <paragraph num="(b)"> <text>Observing the performance of the worker, as appropriate.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Covered Services § Transition Services."> <paragraph num="A."> <text>Definition. “Transition service” means a service that is:</text> <paragraph num="(1)"> <text>Not otherwise available under the Program;</text> </paragraph> <paragraph num="(2)"> <text>Approved in the plan of service; and</text> </paragraph> <paragraph num="(3)"> <text>Rendered to assist the participant in transitioning from an institution or a provider-owned residence to a home or community-based residence.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Transition services may include all or some of the following:</text> <paragraph num="(1)"> <text>Security deposits;</text> </paragraph> <paragraph num="(2)"> <text>Essential furnishings and moving expenses;</text> </paragraph> <paragraph num="(3)"> <text>Set-up fees or deposits for utility services; and</text> </paragraph> <paragraph num="(4)"> <text>Other health and safety assurances.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Transition services may not include recreational items including, but not limited to:</text> <paragraph num="(1)"> <text>Televisions;</text> </paragraph> <paragraph num="(2)"> <text>Cable television access; or</text> </paragraph> <paragraph num="(3)"> <text>Gaming systems.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Conditions for Reimbursement."> <text>The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, if provided in accordance with the requirements of this chapter and if the service:</text> <paragraph num="A."> <text>Is recommended on the participant’s plan of service as necessary in order to:</text> <paragraph num="(1)"> <text>Prevent the applicant’s or participant’s admission to an institution;</text> </paragraph> <paragraph num="(2)"> <text>Safely transition the applicant or participant from an institution, such as a nursing facility, into the community; or</text> </paragraph> <paragraph num="(3)"> <text>Assure the health and safety of an applicant or participant in the community;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Has been preauthorized by the Department in the participant’s plan of service;</text> </paragraph> <paragraph num="C."> <text>Is provided to an enrolled participant;</text> </paragraph> <paragraph num="D."> <text>Is medically necessary; and</text> </paragraph> <paragraph num="E."> <text>Is provided by a Medicaid provider who meets the conditions for participation under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Limitations."> <paragraph num="A."> <text>Reimbursement for Personal Emergency Response System is limited to participants who:</text> <paragraph num="(1)"> <text>Live alone; or</text> </paragraph> <paragraph num="(2)"> <text>Have no regular caregiver for extended parts of the day and would otherwise require extensive routine supervision to ensure the participant’s health and safety.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall establish a budget for personal assistance services and home-delivered meals that may be included in the participant’s plan of service, based on each participant’s assessed need.</text> </paragraph> <paragraph num="C."> <text>The Program does not cover the following services:</text> <paragraph num="(1)"> <text>Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as:</text> <paragraph num="(a)"> <text>Cleaning of the floor and furniture in areas not occupied by the participant;</text> </paragraph> <paragraph num="(b)"> <text>Laundry other than that incidental to services for the participant; and</text> </paragraph> <paragraph num="(c)"> <text>Shopping for groceries or household items unless in the company of the participant;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services provided by providers not approved for participation by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Expenses incurred while escorting participants:</text> <paragraph num="(a)"> <text>To obtain medical diagnosis or treatment;</text> </paragraph> <paragraph num="(b)"> <text>To or from the participant’s workplace; or</text> </paragraph> <paragraph num="(c)"> <text>For participation in social or community activities;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Expenses related to room and board for either the participant or the worker;</text> </paragraph> <paragraph num="(5)"> <text>Transition services more than 60 days post transition;</text> </paragraph> <paragraph num="(6)"> <text>Personal assistance services provided outside the State for more than 30 days per calendar year;</text> </paragraph> <paragraph num="(7)"> <text>Environmental adaptations to the home which:</text> <paragraph num="(a)"> <text>Are of general maintenance, such as carpeting, roof repair, and central air conditioning;</text> </paragraph> <paragraph num="(b)"> <text>Are not of direct medical or remedial benefit to the participant;</text> </paragraph> <paragraph num="(c)"> <text>Add to the home’s total square footage; or</text> </paragraph> <paragraph num="(d)"> <text>Modify the exterior of the home, other than the provision of ramps, lifts, sidewalks necessary to utilize a ramp or lift, and railings; or</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Experimental technology or equipment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for:</text> <paragraph num="(1)"> <text>Administrative overhead;</text> </paragraph> <paragraph num="(2)"> <text>Travel;</text> </paragraph> <paragraph num="(3)"> <text>Internal quality monitoring activities;</text> </paragraph> <paragraph num="(4)"> <text>Staff supervision, training, or consultation; or</text> </paragraph> <paragraph num="(5)"> <text>Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless preauthorized by the Department in writing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment for environmental adaptations and technology that substitutes for human assistance is limited to a combined reimbursement of up to $15,000 over a 3-year period per participant.</text> </paragraph> <paragraph num="F."> <text>For technology items or services above $1,000, multiple quotes from providers are required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .14 of this chapter, a provider and its workers shall use the telephonic timekeeping system approved by the Department to:</text> <paragraph num="(1)"> <text>Document time; and</text> </paragraph> <paragraph num="(2)"> <text>Submit claims.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .15—.21 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual.</text> </paragraph> <paragraph num="C."> <text>Billing time limitations are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments for services rendered to a participant shall be made directly to a qualified provider.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall be paid the lesser of:</text> <paragraph num="(a)"> <text>The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(b)"> <text>The rate established according to the fee schedule published by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Effective May 1, 2017, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid.</text> </paragraph> <paragraph num="F."> <text>Rates.</text> <paragraph num="(1)"> <text>The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2018, the Program’s rates for covered services under Regulations .14—.16, .18D, .19, and .20 of this chapter shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".27" heading="Appeal Procedures — Providers."> <text>Appeal procedures shall be as set forth in:</text> <paragraph num="A."> <text>COMAR 10.09.36.09; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Appeal Procedures — Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in:</text> <paragraph num="A."> <text>COMAR 10.09.24.13; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.01.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Interpretive Regulation."> <text>Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 17, 2014 (41:5 Md. R. 343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, C amended effective June 8, 2015 (42:11 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 724); November 9, 2015 (42:22 Md. R. 1377); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D adopted effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B, C amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18E adopted effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective June 8, 2015 (42:11 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22B amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective April 11, 2016 (43:7 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23B amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23C amended effective June 8, 2015 (42:11 Md. R. 724); February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23E, F adopted effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23D adopted effective November 9, 2015 (42:22 Md. R. 1377)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85); February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, E amended effective June 8, 2015 (42:11 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24F amended effective May 20, 2019 (46:10 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective June 8, 2015 (42:11 Md. R. 724)</annotation> </annotations> </chapter> <chapter num="85" heading="Free-Standing Birth Centers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certified nurse midwife (CNM)” means a registered nurse who is certified by the American College of Nurse-Midwives, and is licensed in the state in which the service is provided.</text> </paragraph> <paragraph num="(2)"> <text>“Commission for the Accreditation of Birth Centers (CABC)” means the independent authority that accredits developing and existing birth centers in the United States of America, according to established national standards.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Free-standing Birth Center” means a free-standing facility not associated with a hospital that provides physician or certified nurse midwifery services.</text> </paragraph> <paragraph num="(5)"> <text>"Medical Assistance Program” means the program, financed by federal, state, and local funds, for the comprehensive medical care for persons of all ages within certain income limits.</text> </paragraph> <paragraph num="(6)"> <text>“Medically necessary” means the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Newborn” means an infant who is not more than 48 hours old.</text> </paragraph> <paragraph num="(8)"> <text>“Participant” means an individual who is eligible for Program benefits.</text> </paragraph> <paragraph num="(9)"> <text>“Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located.</text> </paragraph> <paragraph num="(10)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(11)"> <text>“Provider” means a free-standing birth center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>A free-standing birth center shall be certified by the Commission for the Accreditation of Birth Centers, and:</text> <paragraph num="(1)"> <text>Be licensed to operate in Maryland pursuant to Health General Article 19, Subtitle 3b, Annotated Code of Maryland and in accordance with the requirements as set forth in COMAR 10.05.02; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with the regulations of the jurisdiction in which the free-standing birth center is located.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The free-standing birth center shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or</text> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A CNM providing services in a free-standing birth center shall meet the license requirements in accordance with COMAR 10.09.21.02B.</text> </paragraph> <paragraph num="D."> <text>A physician providing services in a free-standing birth center shall meet the requirements in accordance with COMAR 10.09.02.02B.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Specific requirements for participation in the Program as a free-standing birth center require that the provider:</text> <paragraph num="(1)"> <text>Verify the licenses and credentials of all clinical professionals employed by or under contract with the free-standing birth center as set forth in COMAR 10.05.02.04.</text> </paragraph> <paragraph num="(2)"> <text>Maintain adequate documentation of each participant’s delivery service and newborn care as set forth in COMAR 10.05.02.11.</text> </paragraph> <paragraph num="(3)"> <text>Comply with safety requirements as set forth in COMAR 10.05.02.09 and COMAR 10.05.02.10.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <text>The Program covers the facility-related services provided by the free-standing birth center for the care of the delivering mother and newborn, and covers the cost of;</text> <paragraph num="A."> <text>Support staff;</text> </paragraph> <paragraph num="B."> <text>The use of the free-standing birth center; and</text> </paragraph> <paragraph num="C."> <text>Supplies, linens, and equipment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover laboratory or x-ray services performed by another facility. The facility performing these services shall bill the Program directly.</text> </paragraph> <paragraph num="B."> <text>Professional services are to be billed separately from the free-standing birth center facility fee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Procedures."> <paragraph num="A."> <text>The Program will reimburse free-standing birth centers for:</text> <paragraph num="(1)"> <text>A facility fee of $2,000 for the care of the delivering mother and delivery of the newborn, if the delivery takes place at the facility; and</text> </paragraph> <paragraph num="(2)"> <text>A facility fee of $500 for the care of the newborn.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the mother is transferred to a hospital prior to delivering the newborn, the Department will reimburse as follows:</text> <paragraph num="(1)"> <text>If the mother was at the birth center for less than 2 hours, before the delivery of the newborn, the reimbursement will be at 25 percent of the Medicaid rate;</text> </paragraph> <paragraph num="(2)"> <text>If the mother was at the birth center for 2 to 5 hours, before the delivery of the newborn, the reimbursement will be at 50 percent of the Medicaid rate;</text> </paragraph> <paragraph num="(3)"> <text>If the mother was at the birth center for 5 to 8 hours, before to the delivery of the newborn, the reimbursement will be at 70 percent of the Medicaid rate; and</text> </paragraph> <paragraph num="(4)"> <text>If the mother was at the birth center for more than 8 hours, before the delivery of the newborn, the reimbursement will be at the full Medicaid rate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall pay for covered services at the lower of the:</text> <paragraph num="(1)"> <text>Provider's customary charge to the general public; or</text> </paragraph> <paragraph num="(2)"> <text>The Program’s fee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A.</text> </paragraph> <paragraph num="E."> <text>The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed.</text> </paragraph> <paragraph num="F."> <text>The Program may not make a direct payment to a recipient.</text> </paragraph> <paragraph num="G."> <text>Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>If the recipient has insurance or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="B."> <text>The provider shall reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions"> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeals Procedures."> <text>Appeal procedures are as set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 1, 2014 (41:8 Md. R. 471)</annotation> </annotations> </chapter> <chapter num="86" heading="Maryland Medicaid Managed Care Program: Independent Review Organization (IRO)" reason="Transferred to COMAR 10.67.13"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred to COMAR 10.67.13 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="87" heading="Free-Standing Independent Diagnostic Testing Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“CMS” means Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>"Independent Diagnostic Testing Facility (IDTF)” means a fixed location or mobile entity independent of a hospital or physician’s office where diagnostic services are performed by licensed certified non-physician personnel under appropriate physician supervision.</text> </paragraph> <paragraph num="(4)"> <text>“Major medical equipment” means:</text> <paragraph num="(a)"> <text>All cardiac catheterization equipment necessary to perform heart catheterization;</text> </paragraph> <paragraph num="(b)"> <text>A computerized tomography (CT) scanner;</text> </paragraph> <paragraph num="(c)"> <text>A lithotriptor;</text> </paragraph> <paragraph num="(d)"> <text>Radiation therapy equipment, including a linear accelerator; and</text> </paragraph> <paragraph num="(e)"> <text>A Magnetic Resonance Imager (MRI).</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Mammography” means the radiographic examination of the soft tissues of the breast.</text> </paragraph> <paragraph num="(6)"> <text>“Medically necessary” means medically necessary as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(7)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“NPI” means National Provider Identifier.</text> </paragraph> <paragraph num="(9)"> <text>“Program" means the Maryland Medical Assistance Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text> </paragraph> <paragraph num="B."> <text>A facility or mobile unit that is operating radiological equipment shall be licensed or certified and registered by the Department of the Environment in accordance with COMAR 26.12.01 through COMAR 26.12.03.</text> </paragraph> <paragraph num="C."> <text>A facility that performs mammography services shall be certified by the Food and Drug Administration (FDA).</text> </paragraph> <paragraph num="D."> <text>A facility operating major medical equipment shall meet all the general licensing requirements for a facility as provided in COMAR 10.05.03.02.</text> </paragraph> <paragraph num="E."> <text>The driver of the Mobile IDTF unit:</text> <paragraph num="(1)"> <text>Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; and</text> </paragraph> <paragraph num="(2)"> <text>May not have:</text> <paragraph num="(a)"> <text>Violations related to the operation of a motor vehicle in the last 3 years; and</text> </paragraph> <paragraph num="(b)"> <text>Any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>Requirements for participation in the Program as an IDTF provider/mobile IDTF provider require that the provider:</text> <paragraph num="(1)"> <text>Be approved by Medicare to furnish diagnostic services in an IDTF;</text> </paragraph> <paragraph num="(2)"> <text>Meets the licensure requirements in accordance with Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Meets performance standards in accordance with 42 CFR §410.33(g).</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific Requirements for Participation in the Program as a Mobile IDTF Provider.</text> <paragraph num="(1)"> <text>The mobile IDTF shall have electronic technology that enables the same day exchange of patient records with the treating physician’s office.</text> </paragraph> <paragraph num="(2)"> <text>An IDTF mobile unit shall:</text> <paragraph num="(a)"> <text>Maintain physician’s order & diagnostic test records for each patient;</text> </paragraph> <paragraph num="(b)"> <text>Observe all patient rights;</text> </paragraph> <paragraph num="(c)"> <text>Obtain written, informed consent from a parent or legal guardian before providing services to a minor;</text> </paragraph> <paragraph num="(d)"> <text>Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating:</text> <paragraph num="(i)"> <text>Equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Flammability;</text> </paragraph> <paragraph num="(iii)"> <text>Construction;</text> </paragraph> <paragraph num="(iv)"> <text>Infection control;</text> </paragraph> <paragraph num="(v)"> <text>Sanitation procedures; and</text> </paragraph> <paragraph num="(vi)"> <text>Zoning;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Comply with the statutes and regulations of the Maryland Department of the Environment for all radiographic and imaging equipment;</text> </paragraph> <paragraph num="(f)"> <text>Obtain all applicable county and city licenses or permits necessary to operate the mobile IDTF;</text> </paragraph> <paragraph num="(g)"> <text>Provide access to a ramp or a lift if services are provided to disabled individuals;</text> </paragraph> <paragraph num="(h)"> <text>Have ready access to an adequate supply of potable water, including hot water;</text> </paragraph> <paragraph num="(i)"> <text>Have immediate access to toilet facilities;</text> </paragraph> <paragraph num="(j)"> <text>Have an appropriately covered noncorrosive metal container for refuse and waste materials;</text> </paragraph> <paragraph num="(k)"> <text>Have a carbon monoxide detection device or system installed and in proper working condition;</text> </paragraph> <paragraph num="(l)"> <text>Have written procedures for medical emergencies; and</text> </paragraph> <paragraph num="(m)"> <text>Have appropriate equipment to treat medical emergencies.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The owner or owners of a mobile unit shall submit a business plan to the Department for the mobile unit that includes:</text> <paragraph num="(a)"> <text>The mission of the mobile unit;</text> </paragraph> <paragraph num="(b)"> <text>Verification of ownership of the mobile unit;</text> </paragraph> <paragraph num="(c)"> <text>A list of the technical staff that will render services in the mobile unit; and</text> </paragraph> <paragraph num="(d)"> <text>The targeted population.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers medically necessary radiology services rendered to a recipient in an IDTF when the services are:</text> <paragraph num="(1)"> <text>Rendered in a CMS certified IDTF or an IDTF Mobile Unit;</text> </paragraph> <paragraph num="(2)"> <text>Provided according to the laws and regulations of the state and locality in which they are rendered;</text> </paragraph> <paragraph num="(3)"> <text>Rendered by a physician or supervised technician;</text> </paragraph> <paragraph num="(4)"> <text>Ordered in writing by the treating physician or non-physician practitioner, in accordance with State law, who is enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(5)"> <text>Adequately documented in the recipient’s medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Radiology services include the following:</text> <paragraph num="(1)"> <text>Diagnostic X-rays;</text> </paragraph> <paragraph num="(2)"> <text>Computerized Tomography (CT) procedures;</text> </paragraph> <paragraph num="(3)"> <text>Magnetic Resonance Imaging (MRI);</text> </paragraph> <paragraph num="(4)"> <text>Magnetic Resonance Angiography (MRA);</text> </paragraph> <paragraph num="(5)"> <text>Nuclear medicine imaging and radionuclide used in the procedures;</text> </paragraph> <paragraph num="(6)"> <text>Diagnostic mammography and certain mammography screening;</text> </paragraph> <paragraph num="(7)"> <text>Ultrasound (US procedures);</text> </paragraph> <paragraph num="(8)"> <text>Position Emission Tomography (PET);</text> </paragraph> <paragraph num="(9)"> <text>Radiation oncology; and</text> </paragraph> <paragraph num="(10)"> <text>Bone mass measurements.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Nuclear Medicine Imaging to include Position Emission Tomography (PET) are covered only when billed by providers who are accredited by one of the following:</text> <paragraph num="(1)"> <text>The American College of Radiology;</text> </paragraph> <paragraph num="(2)"> <text>The Intersocietal Accreditation Commission; or</text> </paragraph> <paragraph num="(3)"> <text>The Joint Commission on Accreditation of Health Organizations (JCAHO).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services for which the IDTF provider cannot supply a properly completed order identifying the authorized ordering practitioner by National Provider Identifier (NPI);</text> </paragraph> <paragraph num="B."> <text>IDTF services ordered by an:</text> <paragraph num="(1)"> <text>Individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>Entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Services not adequately documented in the recipient’s medical record;</text> </paragraph> <paragraph num="D."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="E."> <text>Procedures that are the provider as investigational or experimental in nature;</text> </paragraph> <paragraph num="F."> <text>Services which are specifically included as an integral part of another service;</text> </paragraph> <paragraph num="G."> <text>Consultations;</text> </paragraph> <paragraph num="H."> <text>Office Visits;</text> </paragraph> <paragraph num="I."> <text>Injections;</text> </paragraph> <paragraph num="J."> <text>Surgeries; and</text> </paragraph> <paragraph num="K."> <text>Therapeutic services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements. Reserved." /> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>IDTF providers shall identify the individual who ordered the diagnostic services by either:</text> <paragraph num="(1)"> <text>Recording the National Provider Identifier (NPI) number for the individual provider on the claim; or</text> </paragraph> <paragraph num="(2)"> <text>Recording the name and NPI of the authorized ordering provider on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering provider.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall reimburse the IDTF providers for covered services at the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department’s fee schedule.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department’s fee-schedule is contained in COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="E."> <text>Payments on Medicare cross-over claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Program may not make a direct payment to a recipient.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations are those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="I."> <text>The provider may not bill the Program or recipient for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Services rendered by mail or telephone; and</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="88" heading="Portable X-ray Providers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“CMS” means Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Mammography” means the radiographic examination of the soft tissues of the breast.</text> </paragraph> <paragraph num="(4)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(5)"> <text>“Medically necessary” means medically necessary as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(6)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(7)"> <text>“NPI” means National Provider Identifier.</text> </paragraph> <paragraph num="(8)"> <text>“Program” means the Medical Assistance Program.</text> </paragraph> <paragraph num="(9)"> <text>“Portable X-ray provider” means an entity that moves its portable X-ray equipment that is separate from and unattached to the vehicle to a fixed location (e.g. a physician’s office or nursing home).</text> </paragraph> <paragraph num="(10)"> <text>“Provider” means:</text> <paragraph num="(a)"> <text>An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number;</text> </paragraph> <paragraph num="(b)"> <text>An agent, employee, or related party of a person identified in §B(10)(a) of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>An individual or any other person with an ownership interest in a person identified in §B(10)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>Providers of Medical Assistance Program services shall, to the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided.</text> </paragraph> <paragraph num="B."> <text>The provider and the equipment personnel shall be licensed or registered in accordance with applicable federal, State and local laws in accordance with 42 CFR §486.100.</text> </paragraph> <paragraph num="C."> <text>The portable X-ray provider shall be certified and registered by the Department of Environment in accordance with COMAR 26.12.01—.03</text> </paragraph> <paragraph num="D."> <text>A portable X-ray provider that performs mammography services shall be certified by the Food and Drug Administration (FDA).</text> </paragraph> <paragraph num="E."> <text>The driver that transports portable X-ray equipment:</text> <paragraph num="(1)"> <text>Shall possess a valid operator’s license appropriate for the type of vehicle that is driven;</text> </paragraph> <paragraph num="(2)"> <text>May not have violations related to the operation of a motor vehicle in the last 3 years; and</text> </paragraph> <paragraph num="(3)"> <text>May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>The provider shall also:</text> <paragraph num="(1)"> <text>Be certified by CMS to furnish portable X-ray services;</text> </paragraph> <paragraph num="(2)"> <text>Meet the licensure requirements as provided in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Meet performance standards in accordance with 42 CFR §410.33(g);</text> </paragraph> <paragraph num="(4)"> <text>Ensure that portable X-ray services are rendered under the supervision of a qualified physician in accordance with 42 CFR §486.102;</text> </paragraph> <paragraph num="(5)"> <text>Ensure that portable X-ray services are rendered by a qualified technician in accordance with 42 CFR §486.104;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that portable X-ray services performed for Medical Assistance recipients are ordered by a doctor of medicine or a doctor of osteopathy and records are properly preserved in accordance with 42 CFR §486.106;</text> </paragraph> <paragraph num="(7)"> <text>Ensure that inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than 24 months in accordance with 42 CFR §486.110; and</text> </paragraph> <paragraph num="(8)"> <text>Identify the ordering practitioner who authorized the diagnostic services by either:</text> <paragraph num="(a)"> <text>Recording the National Provider Identifier (NPI) number for the individual practitioner on the claim; or</text> </paragraph> <paragraph num="(b)"> <text>Recording the name and NPI of the authorized ordering practitioner on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering practitioner.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers medically necessary services rendered to recipients, when the services are:</text> <paragraph num="(1)"> <text>Provided according to the laws and regulations of the State and locality in which they are rendered in accordance with 42 CFR §486.100;</text> </paragraph> <paragraph num="(2)"> <text>Rendered by a physician who meets the qualification standards in accordance with 42 CFR §486.102 or qualified non-physician (technician) who meets the qualification standards in accordance to 42 CFR §486.104; and</text> </paragraph> <paragraph num="(3)"> <text>Ordered in writing by the treating physician or nurse practitioner who is enrolled as a provider in the Program with an active status on the date of service in accordance with State law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Portable X-ray services include the following:</text> <paragraph num="(1)"> <text>Skeletal films involving extremities, pelvis, vertebral column, and skull;</text> </paragraph> <paragraph num="(2)"> <text>Chest films which do not involve the use of contrast media;</text> </paragraph> <paragraph num="(3)"> <text>Abdominal films which do not involve the use of contrast media;</text> </paragraph> <paragraph num="(4)"> <text>Diagnostic mammograms, if approved by the FDA;</text> </paragraph> <paragraph num="(5)"> <text>Transportation of portable X-ray equipment to a patient’s home or a long term care facility (LTCF); and</text> </paragraph> <paragraph num="(6)"> <text>Electrocardiograms (EKGs/ECGs).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Services for which the portable X-ray provider cannot provide a properly completed order identifying the authorized ordering physician or practitioner by National Provider Identifier (NPI);</text> </paragraph> <paragraph num="B."> <text>Services not adequately documented in the recipient’s medical record;</text> </paragraph> <paragraph num="C."> <text>Services not medically necessary;</text> </paragraph> <paragraph num="D."> <text>Procedures that are known by the provider as investigational or experimental in nature;</text> </paragraph> <paragraph num="E."> <text>Services which are specifically included as an integral part of another service;</text> </paragraph> <paragraph num="F."> <text>Consultations;</text> </paragraph> <paragraph num="G."> <text>Office visits;</text> </paragraph> <paragraph num="H."> <text>Injections;</text> </paragraph> <paragraph num="I."> <text>Surgeries; and</text> </paragraph> <paragraph num="J."> <text>Therapeutic services.</text> </paragraph> <paragraph num="K."> <text>X-ray services ordered by an:</text> <paragraph num="(1)"> <text>Individual who is not enrolled as a provider in the Program with an active status on the date of service; and</text> </paragraph> <paragraph num="(2)"> <text>Entity, facility, or another provider that is not an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirements. Reserved." /> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="B."> <text>The Department shall allow a single transportation payment for each trip the portable X-ray provider makes to a particular location.</text> </paragraph> <paragraph num="C."> <text>The Department shall reimburse for covered services at the lesser of:</text> <paragraph num="(1)"> <text>The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department’s fee schedule.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department’s fee-schedule is contained in COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="E."> <text>Payments on Medicare cross-over claims are authorized if :</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare has determined that the services are medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the program; and</text> </paragraph> <paragraph num="(5)"> <text>The initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall make supplemental payment on Medicare claims subject to the following provisions:</text> <paragraph num="(1)"> <text>Coinsurance shall be paid at the lesser of:</text> <paragraph num="(a)"> <text>100 percent of the coinsurance amount; or</text> </paragraph> <paragraph num="(b)"> <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Program may not make a direct payment to a recipient.</text> </paragraph> <paragraph num="H."> <text>Billing time limitations are those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="I."> <text>The provider may not bill the Program or recipient for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Services rendered by mail or telephone; and</text> </paragraph> <paragraph num="(4)"> <text>Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The portable X-ray provider shall identify the individual who ordered the portable X-ray services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07J adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation> </annotations> </chapter> <chapter num="89" heading="1915(i) Intensive Behavioral Health Services for Children, Youth, and Families"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The purpose of this chapter is to implement a home and community-based services benefit for children and youth with serious emotional disturbances (SED) and their families, authorized under a 1915(i) Medicaid State Plan Amendment. Eligible participants are served by care coordination organizations through a care coordination service delivery model that utilizes child and family teams to create and implement individualized plans of care that are driven by the strengths and needs of the participants and their families.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“1915(c)” means a federal waiver that allows states to provide home- and community-based care to individuals who would otherwise be institutionalized.</text> </paragraph> <paragraph num="(2)"> <text>“1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program described in this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative services organization (ASO)” has the meaning stated in COMAR 10.67.01.01.</text> </paragraph> <paragraph num="(4)"> <text>“Behavioral Health Administration (BHA)” means the Department’s administration, as defined by Health General Article Title XX, Annotated Code of Maryland, or its designee.</text> </paragraph> <paragraph num="(5)"> <text>“Care coordinator” means an individual employed through the care coordination organization that is responsible for providing case management services to 1915(i) participants and families as described in COMAR 10.09.90.</text> </paragraph> <paragraph num="(6)"> <text>“Caregiver” means an individual with responsibility for 24-hour care and supervision of a minor.</text> </paragraph> <paragraph num="(7)"> <text>“Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that is approved by the Department to provide case management services to 1915(i) participants and their families, pursuant to COMAR 10.09.90.</text> </paragraph> <paragraph num="(8)"> <text>“Child and family team (CFT)” means a team of individuals selected by the participant and family to work with them to design and implement the plan of care.</text> </paragraph> <paragraph num="(9)"> <text>“Core service agency (CSA)” has the meaning stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="(10)"> <text>“Crisis plan” means a document that is developed by a CFT to address actions that need to be taken in the event that an individual is experiencing a behavioral health crisis, which is included as part of the plan of care.</text> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health (MDH) or its designee.</text> </paragraph> <paragraph num="(12)"> <text>“Department of Human Services (DHS)” has the meaning stated in Human Services Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Department of Public Safety and Correctional Services (DPSCS)” has the meaning stated in Correctional Services Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Diagnostic Criteria (DC) 0-5” means a system for diagnosing mental health and developmental disorders in infants and toddlers.</text> </paragraph> <paragraph num="(15)"> <text>“Expressive and experiential behavioral services” means the use of art, dance, music, equine, horticulture, or drama to accomplish individualized goals as part of the plan of care.</text> </paragraph> <paragraph num="(16)"> <text>“Family” means:</text> <paragraph num="(a)"> <text>One or more parents and children related by blood, marriage, or adoption, and residing in the same household; or</text> </paragraph> <paragraph num="(b)"> <text>A parent substitute or substitutes, including informal and formal kinship caregivers as set forth in Health-General Article, §20-105, Annotated Code of Maryland, and Education Article, §7-101, Annotated Code of Maryland, or legal guardians, who have responsibility for the 24 hour care and supervision of a child.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Family peer support” means a service as described in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(18)"> <text>“Family peer support partner” means an individual providing family peer-to-peer support services.</text> </paragraph> <paragraph num="(19)"> <text>“Family support organization (FSO)” means an approved entity under Regulation .09D of this chapter.</text> </paragraph> <paragraph num="(20)"> <text>“Institution for mental disease (IMD)” has the meaning stated in COMAR 10.67.01.01B.</text> </paragraph> <paragraph num="(21)"> <text>“Local departments of social services (DSS)” has the meaning stated in Human Services Article, Title 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Maryland Children’s Health Program (MCHP)” has the meaning stated in COMAR 10.09.43.</text> </paragraph> <paragraph num="(23)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.67.02.</text> </paragraph> <paragraph num="(24)"> <text>“Mental health professional” has the meaning stated in COMAR 10.21.17.02.</text> </paragraph> <paragraph num="(25)"> <text>“Natural support” means a family member, friend, or community member, or organization selected by the participant or family, or both, to participate on the CFT.</text> </paragraph> <paragraph num="(26)"> <text>“Participant” means an individual who meets the qualifications, as specified in Regulation .03 of this chapter, for benefit eligibility.</text> </paragraph> <paragraph num="(27)"> <text>“Plan of care (POC)” means a written document that is:</text> <paragraph num="(a)"> <text>Developed by the CFT that describes the services to be provided to the participant; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Department in accordance with 42 CFR §441.301.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(29)"> <text>“Provider” means an individual or entity that has enrolled with the Program to provide one or more benefit services covered under this chapter.</text> </paragraph> <paragraph num="(30)"> <text>“Public mental health system” means the system for the delivery of mental health treatment and supports to eligible individuals as described in COMAR 10.67.08.</text> </paragraph> <paragraph num="(31)"> <text>“Residential treatment center” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food provided in or associated with an individual’s place of residence.</text> </paragraph> <paragraph num="(33)"> <text>“Respite care” has the meaning stated in COMAR 10.21.27.</text> </paragraph> <paragraph num="(34)"> <text>“Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="(35)"> <text>“Service area” means, during the phase-in of the 1915(i), the geographic area in Maryland where the 1915(i) is available.</text> </paragraph> <paragraph num="(36)"> <text>“State Plan” means the Plan described in §1902(a) of Title XIX of the Social Security Act.</text> </paragraph> <paragraph num="(37)"> <text>“Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>For an applicant to be eligible for 1915(i) services, the applicant shall meet all of the criteria in §§B—H of this regulation.</text> </paragraph> <paragraph num="B."> <text>The applicant shall be younger than 18 years old at the time of enrollment.</text> </paragraph> <paragraph num="C."> <text>The applicant shall reside in a home- and community-based setting that is:</text> <paragraph num="(1)"> <text>Located in the 1915(i) service area; and</text> </paragraph> <paragraph num="(2)"> <text>Not any of the following excluded settings:</text> <paragraph num="(a)"> <text>Therapeutic Group Home (TGH) licensed by the Behavioral Health Administration (BHA) under COMAR 10.21.07;</text> </paragraph> <paragraph num="(b)"> <text>Psychiatric Respite Care facility located on the grounds of an institution for mental disease (IMD) for the purpose of placement;</text> </paragraph> <paragraph num="(c)"> <text>Residential program for adults with serious mental illness licensed under COMAR 10.63; or</text> </paragraph> <paragraph num="(d)"> <text>Group residential facility licensed under COMAR 10.63.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Consent.</text> <paragraph num="(1)"> <text>For individuals younger than 16 years old, the family or medical guardian of the participant shall give consent for the individual to participate in the 1915(i);</text> </paragraph> <paragraph num="(2)"> <text>For individuals 16 years old or older, the individual shall give consent to participate in the 1915(i).</text> </paragraph> </paragraph> <paragraph num="E."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Have a face-to-face psychosocial assessment completed or updated within 30 days of submission of the enrollment to the ASO that:</text> <paragraph num="(a)"> <text>Assigns a Diagnostic and Statistical Manual (DSM) behavioral health diagnosis or Diagnostic Criteria (DC) 0-5 diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Determines the applicant to be amenable to active clinical treatment; and</text> </paragraph> <paragraph num="(c)"> <text>Is conducted by a provider not associated with the CCO by which the participant may eventually be served; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet the Department’s written medical necessity criteria.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The accessibility or intensity of currently available community supports and services are inadequate to meet the applicant’s needs due to the severity of the impairment without the provision of one or more of the services contained in the 1915(i) benefit.</text> </paragraph> <paragraph num="G."> <text>The applicant may not be served in a Health Home as defined in COMAR 10.09.33 while enrolled in the 1915(i).</text> </paragraph> <paragraph num="H."> <text>Medical Assistance Eligibility.</text> <paragraph num="(1)"> <text>Categorically Needy. An applicant is eligible for 1915(i) services if the applicant is eligible for Medicaid or Maryland Children’s Health Program (MCHP) in accordance with COMAR 10.09.11 or 10.09.24 and has a family income that does not exceed 300 percent of the Federal Poverty Line (FPL).</text> </paragraph> <paragraph num="(2)"> <text>Optional Categorically Needy. An applicant is eligible for the 1915(i) benefit as optionally categorically needy in accordance with §1902(a)(10)(A)(ii)(XXII) if the individual is receiving services through an existing 1915(c) HCBS waiver program.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Department may assist applicants in the benefit application process by:</text> <paragraph num="(1)"> <text>Informing the applicant and family verbally and in writing about services available in the 1915(i);</text> </paragraph> <paragraph num="(2)"> <text>Assisting the applicant and family to complete the eligibility determination for Medical Assistance for the 1915(i), if necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Once Medical Assistance eligibility is determined, ensuring that the assessments and documentation required for a medical necessity determination are obtained and provided to the Department.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Based on the criteria established in §§A—H of this regulation:</text> <paragraph num="(1)"> <text>An applicant’s eligibility for services under this regulation shall be established by the Department;</text> </paragraph> <paragraph num="(2)"> <text>There is no retroactive eligibility; and</text> </paragraph> <paragraph num="(3)"> <text>Benefit eligibility may not begin before:</text> <paragraph num="(a)"> <text>Verification of the applicant’s Medical Assistance eligibility for the 1915(i); and</text> </paragraph> <paragraph num="(b)"> <text>Completion of the independent evaluation by the Department that the applicant meets all criteria established in §§A—H of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>If the applicant is determined to meet the needs-based eligibility criteria as established in §§A—H of this regulation, the Department shall:</text> <paragraph num="(1)"> <text>Obtain written consent from the family or medical guardian to participate in the 1915(i); and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the participant is referred immediately upon enrollment determination to a CCO.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The Department shall re-evaluate a participant’s:</text> <paragraph num="(1)"> <text>Needs-based eligibility for 1915(i) services as specified in §§A—G of this regulation every 12 months, or more frequently due to a significant change in the participant’s condition or needs, in accordance with the Department’s medical necessity criteria; and</text> </paragraph> <paragraph num="(2)"> <text>Medical Assistance eligibility for 1915(i) services in accordance with the Department’s redetermination policy for all Medical Assistance enrollees.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Termination of Participant Enrollment."> <paragraph num="A."> <text>A participant shall be disenrolled from the 1915(i), as of the date established by the Department, if the participant:</text> <paragraph num="(1)"> <text>No longer meets all of the criteria for 1915(i) eligibility specified in §§A—H of Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Voluntarily chooses to disenroll from the benefit, if the participant is 18 years old, or the participant’s family or medical guardian chooses to do so on behalf of a participant who is younger than 18 years old or in the custody of the State, or both;</text> </paragraph> <paragraph num="(3)"> <text>Is hospitalized for longer than 30 days;</text> </paragraph> <paragraph num="(4)"> <text>Moves out of the service area and cannot reasonably access services and supports;</text> </paragraph> <paragraph num="(5)"> <text>Is admitted to and placed in an RTC for longer than 60 days;</text> </paragraph> <paragraph num="(6)"> <text>Is admitted to and placed in a Therapeutic Group Home (TGH) licensed by BHA under COMAR 10.21.07 or an adult residential program approved under COMAR 10.21.22;</text> </paragraph> <paragraph num="(7)"> <text>Is placed in a Psychiatric Respite Care program, a non-medical group residential facility located on the grounds of an IMD primarily for the purpose of placement;</text> </paragraph> <paragraph num="(8)"> <text>Loses eligibility for Maryland Medical Assistance;</text> </paragraph> <paragraph num="(9)"> <text>Turns 22 years old;</text> </paragraph> <paragraph num="(10)"> <text>Is detained, committed to a juvenile justice or correctional facility, or incarcerated for longer than 60 days;</text> </paragraph> <paragraph num="(11)"> <text>Does not meet medical re-certification criteria;</text> </paragraph> <paragraph num="(12)"> <text>Does not participate in a Child and Family Team (CFT) meeting within 90 days;</text> </paragraph> <paragraph num="(13)"> <text>Is no longer actively engaged in ongoing behavioral health treatment with a licensed mental health professional; or</text> </paragraph> <paragraph num="(14)"> <text>Is placed in a group residential facility licensed under COMAR 14.31.05—.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant who is not receiving 1915(i) services continuously after reaching age 18 is ineligible to enroll in the program at a later date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="1915(i) Model."> <paragraph num="A."> <text>The 1915(i) shall provide community-based treatment to children with SED or co-occurring diagnosis through the care coordination model.</text> </paragraph> <paragraph num="B."> <text>Enrollment in 1915(i) services qualifies and requires the participant to receive case management services through a CCO, pursuant to COMAR 10.09.90.</text> </paragraph> <paragraph num="C."> <text>Each participant shall have an individualized POC that is managed by the CCO, pursuant to COMAR 10.09.90:</text> </paragraph> <paragraph num="D."> <text>In partnership with the CFT, the CCO shall:</text> <paragraph num="(1)"> <text>Reevaluate the POC at least every 45 days with re-administration of BHA-approved assessments as appropriate, and more frequently in response to a crisis;</text> </paragraph> <paragraph num="(2)"> <text>Determine the family vision, which will guide the planning process;</text> </paragraph> <paragraph num="(3)"> <text>Identify strengths of the entire team;</text> </paragraph> <paragraph num="(4)"> <text>Determine the needs that the team will work on;</text> </paragraph> <paragraph num="(5)"> <text>Determine outcome statements for meeting identified needs;</text> </paragraph> <paragraph num="(6)"> <text>Determine the specific services and supports required in order to achieve the goals identified in the POC;</text> </paragraph> <paragraph num="(7)"> <text>Create a mission statement that the team generates and commits to following;</text> </paragraph> <paragraph num="(8)"> <text>Identify the individuals responsible for each of the strategies in the POC;</text> </paragraph> <paragraph num="(9)"> <text>Review and update the crisis plan; and</text> </paragraph> <paragraph num="(10)"> <text>Meet at least every 45 days or more frequently as clinically indicated to:</text> <paragraph num="(a)"> <text>Coordinate the implementation of the POC; and</text> </paragraph> <paragraph num="(b)"> <text>Re-evaluate and update the POC as necessary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Benefit participants shall have access to specialty behavioral health services through the Department’s public behavioral health system. Participants shall also be enrolled in the Medical Assistance Program’s managed care program, known as HealthChoice, in accordance with eligibility requirements set forth in COMAR 10.67.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Conditions for Provider Participation."> <paragraph num="A."> <text>The Department shall grant approval to providers to be eligible to receive Medicaid funds for 1915(i) services if the provider meets the requirements set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>Application. To provide 1915(i) services, a provider applicant shall:</text> <paragraph num="(1)"> <text>Submit an application to the Department on the form approved by the Department, with all questions answered and all required documents attached; and</text> </paragraph> <paragraph num="(2)"> <text>Attest that the provider applicant is in compliance with the general provider requirements and specific 1915(i) service requirements set forth in this chapter and in COMAR 10.09.36.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application Modification.</text> <paragraph num="(1)"> <text>A provider that proposes to change its 1915(i) service sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department.</text> </paragraph> <paragraph num="(2)"> <text>If the Department approves the application modification, the existing provider approval shall extend to the additional site, as applicable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Approval.</text> <paragraph num="(1)"> <text>The Department may grant approval to an applicant provider if the Department determines that the provider:</text> <paragraph num="(a)"> <text>Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and</text> </paragraph> <paragraph num="(b)"> <text>Attests that it complies with the requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the provider is granted approval under §D(1) of this regulation, to continue to be approved, the provider shall maintain documentation of compliance with the requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Sale or Transfer of Approval.</text> <paragraph num="(1)"> <text>The Department’s approval of a 1915(i) service provider is valid only for the provider to which the Department grants approval.</text> </paragraph> <paragraph num="(2)"> <text>A provider may not sell, assign, or transfer approval to another provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Denial, Emergency Suspension of Approval, and Disciplinary Action."> <paragraph num="A."> <text>Denial of Approval.</text> <paragraph num="(1)"> <text>If the Department proposes to deny approval to an applicant under the provisions of this chapter, the Department shall give written notice of the proposed denial to the:</text> <paragraph num="(a)"> <text>Provider applicant;</text> </paragraph> <paragraph num="(b)"> <text>Care coordination organization (CCO); and</text> </paragraph> <paragraph num="(c)"> <text>Administrative service organization (ASO).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the notice under §A(1) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The date on which the Department proposes to deny approval;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed denial of approval;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed denial is based;</text> </paragraph> <paragraph num="(d)"> <text>Notification that before the denial of approval, the provider may request a hearing under the provisions of COMAR 10.21.16; and</text> </paragraph> <paragraph num="(e)"> <text>When feasible, notification of a case resolution conference.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Disciplinary Action.</text> <paragraph num="(1)"> <text>The Department may propose to take any of the following disciplinary actions against a provider:</text> <paragraph num="(a)"> <text>Revocation of approval;</text> </paragraph> <paragraph num="(b)"> <text>Suspension of approval;</text> </paragraph> <paragraph num="(c)"> <text>Probation with conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Banning new admissions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may propose to take one of the actions outlined in §B(1) of this regulation if the provider:</text> <paragraph num="(a)"> <text>Is out of compliance with the requirements of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Fails to maintain financial viability; or</text> </paragraph> <paragraph num="(c)"> <text>Obtains or attempts to obtain approval or payment by fraud, misrepresentation, or the submission of false information to the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except under §C of this regulation, the Department shall send written notice of the proposed action not less than 45 calendar days in advance of the proposed action taken under this regulation to the:</text> <paragraph num="(a)"> <text>Provider;</text> </paragraph> <paragraph num="(b)"> <text>CCO;</text> </paragraph> <paragraph num="(c)"> <text>ASO; and</text> </paragraph> <paragraph num="(d)"> <text>Applicable CSA.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the notice under §B(3) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The date on which the Department proposes to take action and, when feasible, the date of a case resolution conference;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed action;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed action is based; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that, before the action, the provider has the right to request a hearing under the provisions of COMAR 10.21.16.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, after notice and opportunity to be heard, the Department takes disciplinary action, the provider shall, within 10 working days:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the action; and</text> </paragraph> <paragraph num="(b)"> <text>If the program ceases operations:</text> <paragraph num="(i)"> <text>Notify individuals or the guardians of individuals receiving services of the suspension; and</text> </paragraph> <paragraph num="(ii)"> <text>Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals served by the provider.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency Suspension of Approval.</text> <paragraph num="(1)"> <text>Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a provider, the Department may order the immediate suspension of the approval of the provider and the cessation of operation.</text> </paragraph> <paragraph num="(2)"> <text>If the Department takes the action under §C(1) of this regulation, the Department shall promptly give written notice of the proposed emergency suspension to the:</text> <paragraph num="(a)"> <text>Provider;</text> </paragraph> <paragraph num="(b)"> <text>CCO;</text> </paragraph> <paragraph num="(c)"> <text>ASO; and,</text> </paragraph> <paragraph num="(d)"> <text>Applicable CSA.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the notice under §C(2) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The proposed effective date of the emergency suspension;</text> </paragraph> <paragraph num="(b)"> <text>When feasible, the date of a pre-deprivation hearing and a case resolution conference before the Department’s final action;</text> </paragraph> <paragraph num="(c)"> <text>The findings under §C(1) of this regulation and the reasons that support the findings; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that:</text> <paragraph num="(i)"> <text>Following the emergency suspension, the provider may request a hearing under the provisions of COMAR 10.21.16; and</text> </paragraph> <paragraph num="(ii)"> <text>The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Department suspends approval, the provider shall immediately:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the suspension;</text> </paragraph> <paragraph num="(b)"> <text>Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals in the program; and</text> </paragraph> <paragraph num="(c)"> <text>Cease operations of the program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="General Conditions for 1915(i) Services Provider Participation."> <paragraph num="A."> <text>A provider of 1915(i) services shall:</text> <paragraph num="(1)"> <text>Provide the documentation required by the Department for initial approval and provider recertification, or as requested by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Be approved by the Department as meeting the requirements of being able to provide the services set forth in this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Have a provider agreement in effect, to include adherence to quality assurance, auditing, and monitoring policies and procedures;</text> </paragraph> <paragraph num="(4)"> <text>Receive training and certification as required and approved by the Department and determined to be appropriate for the level and scope of services provided;</text> </paragraph> <paragraph num="(5)"> <text>Meet all the conditions for participation in COMAR 10.09.36 except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Maintain general liability insurance, and provide proof of this insurance:</text> <paragraph num="(a)"> <text>At the time of initial application to be a provider of 1915(i) services;</text> </paragraph> <paragraph num="(b)"> <text>At recertification; and</text> </paragraph> <paragraph num="(c)"> <text>Upon request by the Department;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Make available to the Department and federal funding agents all records for inspection and copying, including but not limited to:</text> <paragraph num="(a)"> <text>Personnel files for each individual employed, regardless of method of compensation;</text> </paragraph> <paragraph num="(b)"> <text>Financial records;</text> </paragraph> <paragraph num="(c)"> <text>Treatment records; and</text> </paragraph> <paragraph num="(d)"> <text>Service records;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Comply with the following prohibitions against utilization of staff:</text> <paragraph num="(a)"> <text>Unless waived by the Department in accordance with §D of this regulation, prohibit from working with the participant or the participant’s family any staff, volunteers, students, or any individual who is:</text> <paragraph num="(i)"> <text>Convicted of, received probation before judgment, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft; or</text> </paragraph> <paragraph num="(ii)"> <text>Has an indicated finding of child abuse or neglect; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>Maintain administrative and medical records documenting the date, time, duration, and substantive notes associated with the services delivered, which shall be signed by the provider and indicated by the participant’s plan of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and any individual providing services to participants and their families in the 1915(i):</text> <paragraph num="(1)"> <text>Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Request that DPSCS send the report to:</text> <paragraph num="(a)"> <text>The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or</text> </paragraph> <paragraph num="(b)"> <text>To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Review the results of the background checks;</text> </paragraph> <paragraph num="(4)"> <text>Store background checks in a secure manner consistent with State and federal law; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Required Check for Abuse or Neglect. For each individual providing services to participants and the participant’s families in the 1915(i), the provider shall:</text> <paragraph num="(1)"> <text>Before employing any individual, submit a notarized Consent for Release of Information/Background Clearance Request form to the Department of Human Services (DHS) or a local department of social services (DSS) in the jurisdiction in which the individual lives, pursuant to COMAR 07.02.07.19; and</text> </paragraph> <paragraph num="(2)"> <text>Request that DHS or the local DSS send the report to:</text> <paragraph num="(a)"> <text>The director of the agency if the request is from a provider agency concerning staff, volunteers, or students who will work with the participant or family; or</text> </paragraph> <paragraph num="(b)"> <text>To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>To provide 1915(i) services, an individual may not:</text> <paragraph num="(1)"> <text>Be the participant’s family member;</text> </paragraph> <paragraph num="(2)"> <text>Have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or</text> </paragraph> <paragraph num="(3)"> <text>Be cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that:</text> <paragraph num="(1)"> <text>For criminal background checks:</text> <paragraph num="(a)"> <text>The conviction, the probation before judgment, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application;</text> </paragraph> <paragraph num="(b)"> <text>The criminal history does not indicate behavior that is potentially harmful to participants; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For abuse and neglect findings:</text> <paragraph num="(a)"> <text>The indicated finding occurred more than 7 years before the date of the clearance request;</text> </paragraph> <paragraph num="(b)"> <text>The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Program covers the services listed in this chapter when the services are:</text> <paragraph num="(1)"> <text>Determined by the Department to be medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Preauthorized by Department; and</text> </paragraph> <paragraph num="(3)"> <text>Delivered in accordance with the participant’s POC.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services — Family Peer Support Services."> <text>Family peer support services:</text> <paragraph num="A."> <text>May be provided without the presence of the participant;</text> </paragraph> <paragraph num="B."> <text>Are delivered by a family peer support partner employed by a family support organization (FSO);</text> </paragraph> <paragraph num="C."> <text>May include, but are not limited to:</text> <paragraph num="(1)"> <text>Explaining the role and function of the FSO to newly enrolled families and creating linkages to other peers and supports in the community;</text> </paragraph> <paragraph num="(2)"> <text>Working with the participant and family to identify and articulate concerns, needs, and vision for the future of the participant;</text> </paragraph> <paragraph num="(3)"> <text>Ensuring family and participant opinions and perspectives are incorporated into the CFT process and POC:</text> <paragraph num="(a)"> <text>Through communication with the care coordinator and team members; and</text> </paragraph> <paragraph num="(b)"> <text>By attending CFT meetings with the family to support family decision-making and choice of options;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Listening to the family express needs and concerns and offering suggestions for engagement in the treatment process;</text> </paragraph> <paragraph num="(5)"> <text>Helping the family identify and engage its own natural support system and facilitating the family attending peer support groups and other FSO activities throughout the POC process;</text> </paragraph> <paragraph num="(6)"> <text>Working with the family:</text> <paragraph num="(a)"> <text>To organize and prepare for meetings in order to maximize participation in meetings;</text> </paragraph> <paragraph num="(b)"> <text>By informing the family about options and possible outcomes in selecting services and supports to assist with informed decision-making; and</text> </paragraph> <paragraph num="(c)"> <text>By supporting the family in meetings at school and other locations in the community and during court hearings;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Empowering the family to make choices to achieve desired outcomes for the participant as well as the entire family; and</text> </paragraph> <paragraph num="(8)"> <text>Helping the family to acquire the skills and knowledge needed to attain greater self-sufficiency and maximum autonomy and assisting the family to develop the skills and confidence to independently identify, seek out and access resources that will assist in:</text> <paragraph num="(a)"> <text>Managing and mitigating the participant's behavioral health condition or conditions;</text> </paragraph> <paragraph num="(b)"> <text>Preventing the development of secondary or other chronic conditions;</text> </paragraph> <paragraph num="(c)"> <text>Promoting optimal physical and behavioral health; and</text> </paragraph> <paragraph num="(d)"> <text>Addressing and encouraging activities related to health and wellness.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Are provided by a family support organization (FSO) that:</text> <paragraph num="(1)"> <text>Is designated as a private, nonprofit entity designated under §501(c)(3) of the Internal Revenue Service Code, and submits copies of the certificate of incorporation and Internal Revenue Service designation;</text> </paragraph> <paragraph num="(2)"> <text>Has a board of directors comprised of more than 50 percent of individuals who are:</text> <paragraph num="(a)"> <text>Caregivers with a current or previous primary daily responsibility for raising a child or youth with behavioral health challenges,</text> </paragraph> <paragraph num="(b)"> <text>Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(2)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submits a list of board members with identification of those who are caregivers meeting the criteria in §D(2)(b) of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Establishes hiring practices that give preference to:</text> <paragraph num="(a)"> <text>Current or previous caregivers of a child or youth with behavioral health challenges;</text> </paragraph> <paragraph num="(b)"> <text>Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(4)(a) and (b) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Submits a copy of the organization's personnel policy that sets forth the preferred employment criteria stated in §D(4) of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Employs a staff that is comprised of at least 75 percent of individuals who are:</text> <paragraph num="(a)"> <text>Current or previous caregivers of a child or youth with behavioral health challenges; or</text> </paragraph> <paragraph num="(b)"> <text>Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Submits a list of staff and positions held with identification of those who fit the experienced caregiver and consumer criteria stated in §D(6) of this regulation; and</text> </paragraph> <paragraph num="(8)"> <text>Submits a certificate of eligibility that includes:</text> <paragraph num="(a)"> <text>Attestation of compliance with §D(1)—(6) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The organization’s mission statement that establishes the purpose of the organization as providing support and education to youth with emotional, behavioral, or mental health challenges and their caregivers; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Shall be provided by family peer support partners who:</text> <paragraph num="(1)"> <text>Are employed by an FSO;</text> </paragraph> <paragraph num="(2)"> <text>Are 18 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Receive supervision from an individual who:</text> <paragraph num="(a)"> <text>Is 21 years old or older; and</text> </paragraph> <paragraph num="(b)"> <text>Has at least 3 years of experience providing family peer-to-peer support or working with children with serious behavioral health challenges and their families;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have current or prior experience as a caregiver of a child with behavioral health challenges or be an individual who has experience with State or local services and systems as a consumer who has or had behavioral health challenges; and</text> </paragraph> <paragraph num="(5)"> <text>Receive training and certification as approved by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Covered Services — Respite Services."> <text>Respite services:</text> <paragraph num="A."> <text>Include a set of specific short-term services documented in the POC that include:</text> <paragraph num="(1)"> <text>A schedule of the participant's activities during respite;</text> </paragraph> <paragraph num="(2)"> <text>Medication monitoring, if needed;</text> </paragraph> <paragraph num="(3)"> <text>The frequency, duration, and intensity of staff support;</text> </paragraph> <paragraph num="(4)"> <text>Respite locations; and</text> </paragraph> <paragraph num="(5)"> <text>The aftercare plan or recommendations;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Include community-based respite services, which are provided in the participant's home or other community-based setting;</text> </paragraph> <paragraph num="C."> <text>Include out-of-home respite services, which provide a temporary overnight living arrangement outside of the participant’s home; and</text> </paragraph> <paragraph num="D."> <text>Are provided by organizations that shall:</text> <paragraph num="(1)"> <text>Meet the requirements of COMAR 10.63.03.15;</text> </paragraph> <paragraph num="(2)"> <text>Employ respite care specialists who are:</text> <paragraph num="(a)"> <text>21 years old or older and have a high school diploma or high school equivalency; or</text> </paragraph> <paragraph num="(b)"> <text>At least 18 years old and enrolled in, or in possession of at least an associate degree from, an accredited college or university in a human services field, and are limited to providing services to participants under 13 years of age;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensure that community-based respite services are provided in the participant's home or other community-based setting; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that out-of-home respite services are:</text> <paragraph num="(a)"> <text>Provided in a community-based temporary overnight living arrangement outside the participant's home; and</text> </paragraph> <paragraph num="(b)"> <text>Where applicable, delivered in accordance with COMAR 14.31.05—14.31.07.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Services — Expressive and Experiential Behavioral Services."> <paragraph num="A."> <text>Expressive and experiential behavioral services:</text> <paragraph num="(1)"> <text>May be provided to an individual or group;</text> </paragraph> <paragraph num="(2)"> <text>Provide sensory modalities to participants to assist in achieving POC objectives; and</text> </paragraph> <paragraph num="(3)"> <text>Include:</text> <paragraph num="(a)"> <text>Art behavioral services;</text> </paragraph> <paragraph num="(b)"> <text>Dance behavioral services;</text> </paragraph> <paragraph num="(c)"> <text>Equine-assisted behavioral services;</text> </paragraph> <paragraph num="(d)"> <text>Horticultural behavioral services;</text> </paragraph> <paragraph num="(e)"> <text>Music behavioral services; or</text> </paragraph> <paragraph num="(f)"> <text>Drama behavioral services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Qualification to Provide Expressive and Experiential Behavioral Services.</text> <paragraph num="(1)"> <text>To provide expressive and experiential behavioral services, an individual shall have:</text> <paragraph num="(a)"> <text>A bachelor's or master's degree from an accredited college or university; and</text> </paragraph> <paragraph num="(b)"> <text>Current registration in the applicable association as outlined in §E(5) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Association Registration.</text> <paragraph num="(a)"> <text>Art Behavioral Services. To provide art behavioral services, an individual shall be currently registered as a registered art therapist by:</text> <paragraph num="(i)"> <text>The Art Therapy Credentials Board in the American Art Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For Dance Behavioral Services. To provide dance behavioral services, an individual shall be currently registered as a dance therapist registered, or an academy of dance therapists registered in:</text> <paragraph num="(i)"> <text>The American Dance Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For Equine-Assisted Behavioral Services. To provide equine-assisted behavioral services, an individual shall be currently certified by:</text> <paragraph num="(i)"> <text>The Equine Assisted Growth and Learning Association (EAGALA) to provide services under the EAGALA model;</text> </paragraph> <paragraph num="(ii)"> <text>Professional Association of Therapeutic Horsemanship International (PATHI); or</text> </paragraph> <paragraph num="(iii)"> <text>A comparable association with certification requirements at least equivalent to EAGALA or PATHI.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For Horticultural Behavioral Services. To provide horticultural behavioral services, an individual shall be currently registered as a horticultural therapist registered in:</text> <paragraph num="(i)"> <text>The American Horticultural Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For Music Behavioral Services. To provide music behavioral services, an individual shall be currently registered as a music therapist-board certified by:</text> <paragraph num="(i)"> <text>The Certification Board for Music Therapists, Inc; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>For Drama Behavioral Services. To provide psychodrama/drama behavioral services, an individual shall be currently registered as a registered drama therapist or a board certified trainer in:</text> <paragraph num="(i)"> <text>The National Association for Drama Therapy; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Covered Services — Intensive In-Home Services."> <paragraph num="A."> <text>Intensive In-Home Services (IIHS):</text> <paragraph num="(1)"> <text>Are strengths-based interventions with the child and his or her identified family that includes a series of components, such as:</text> <paragraph num="(a)"> <text>Functional assessments and treatment planning;</text> </paragraph> <paragraph num="(b)"> <text>Individualized interventions;</text> </paragraph> <paragraph num="(c)"> <text>Crisis response and intervention; or</text> </paragraph> <paragraph num="(d)"> <text>Transition support;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May be provided to the child alone, to other family members, or to the child and family members together;</text> </paragraph> <paragraph num="(3)"> <text>Are intended to support a child to remain in his or her home and reduce hospitalizations and out-of-home placements or changes of living arrangements through focused intervention in the home and community; and</text> </paragraph> <paragraph num="(4)"> <text>May be used in situations such as the start of a child's enrollment in the 1915(i), upon discharge from a hospital or residential treatment center, or to prevent or stabilize after a crisis situation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Types of IIHS Providers. The Department may approve two types of IIHS providers:</text> <paragraph num="(1)"> <text>Evidence-Based Practice (EBP)-IIHS providers, to include providers of EBPs as determined by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Promising Practice IIHS providers (non-EBP), to include providers of the In-Home Intervention Program for Children (IHIP-C) and other promising practices, as determined by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An EBP-IIHS provider shall have a certificate or letter from the national or intermediate surveyor or developer of the particular evidence-based practice to demonstrate that the EBP-IIHS provider meets all requirements for Department-approved EBP-IIHS, to include participating in all fidelity monitoring activities.</text> </paragraph> <paragraph num="D."> <text>A Non-EBP IIHS provider shall:</text> <paragraph num="(1)"> <text>Be a Department-approved IHIP-C provider or have a certificate or letter from a national or intermediate purveyor or developer of another promising practice; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>All non-EBP IIHS providers not approved by the Department as IHIP-C providers shall:</text> <paragraph num="(1)"> <text>Ensure that there are Clinical Supervisors and staff who are responsible for creating, implementing, and managing the treatment plan with the child and family and the CFT;</text> </paragraph> <paragraph num="(2)"> <text>Provide crisis response services for the participants on the IIHS provider's caseload and ensure that on-call and crisis intervention services are:</text> <paragraph num="(a)"> <text>Provided by a licensed mental health professional trained in the intervention;</text> </paragraph> <paragraph num="(b)"> <text>Available 24-hours per day, 7 days per week, during the hours the provider is not open to the individual enrolled in the treatment; and</text> </paragraph> <paragraph num="(c)"> <text>In compliance with staffing, supervision, training, data collection, and fidelity monitoring requirements set forth by the purveyor, developer, or MDH and approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Employ Clinical Supervisors who:</text> <paragraph num="(a)"> <text>Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a:</text> <paragraph num="(i)"> <text>Licensed certified social worker-clinical (LCSW-C);</text> </paragraph> <paragraph num="(ii)"> <text>Licensed clinical professional counselor (LCPC);</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist;</text> </paragraph> <paragraph num="(iv)"> <text>Psychiatrist;</text> </paragraph> <paragraph num="(v)"> <text>Nurse psychotherapist; or</text> </paragraph> <paragraph num="(vi)"> <text>Advanced practice registered nurse/psychiatric mental health (APRN-PMH); and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Have at least 3 years of experience in providing mental health treatment to children and families;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Employ mental health professionals who:</text> <paragraph num="(a)"> <text>Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a:</text> <paragraph num="(i)"> <text>Licensed certified social worker (LCSW);</text> </paragraph> <paragraph num="(ii)"> <text>LCSW-C;</text> </paragraph> <paragraph num="(iii)"> <text>LCPC;</text> </paragraph> <paragraph num="(iv)"> <text>Psychologist;</text> </paragraph> <paragraph num="(v)"> <text>Psychiatrist;</text> </paragraph> <paragraph num="(vi)"> <text>Nurse psychotherapist; or</text> </paragraph> <paragraph num="(vii)"> <text>APRN-PMH.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Are supervised by a clinical lead supervisor;</text> </paragraph> <paragraph num="(c)"> <text>See the child in-person at least once per 7 days while receiving IIHS services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Employ in-home stabilizers who:</text> <paragraph num="(a)"> <text>Support the implementation of the treatment plan, but are not responsible for creating it or modifying it;</text> </paragraph> <paragraph num="(b)"> <text>Are at least 21 years old;</text> </paragraph> <paragraph num="(c)"> <text>Have at least a high school diploma or equivalency; and</text> </paragraph> <paragraph num="(d)"> <text>Have completed relevant, comprehensive, appropriate training before providing services, as outlined by the purveyor, developer, or the Department and approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provide a minimum of one face-to-face contact with the participant per week of service;</text> </paragraph> <paragraph num="(7)"> <text>Ensure a minimum of 50 percent of the mental health professionals' contacts with the participant or family, or both, is face-to-face; and</text> </paragraph> <paragraph num="(8)"> <text>Ensure that a minimum of 50 percent of the mental health professionals' time is spent working outside the agency's office and in the participant's home or community, as documented in case notes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Limitations."> <paragraph num="A."> <text>Reimbursement shall be made by the Program only when all of the requirements of this chapter are met.</text> </paragraph> <paragraph num="B."> <text>The Program may not reimburse for:</text> <paragraph num="(1)"> <text>Services that are:</text> <paragraph num="(a)"> <text>Provided by a member of the recipient’s immediate family or an individual who resides in the recipient’s home;</text> </paragraph> <paragraph num="(b)"> <text>Not preauthorized by the Department;</text> </paragraph> <paragraph num="(c)"> <text>Not medically necessary;</text> </paragraph> <paragraph num="(d)"> <text>Beyond the provider’s scope of practice;</text> </paragraph> <paragraph num="(e)"> <text>Not appropriately documented;</text> </paragraph> <paragraph num="(f)"> <text>Part of another service paid for by the State; or</text> </paragraph> <paragraph num="(g)"> <text>Provided without a valid required license or appropriate credentials as specified in this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completion of forms or reports;</text> </paragraph> <paragraph num="(3)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(4)"> <text>Time spent in travel by the provider to and from site of service, except when with the participant or the participant’s family; or</text> </paragraph> <paragraph num="(5)"> <text>Costs of travel by the provider to and from the site of service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program may not reimburse more than the following:</text> <paragraph num="(1)"> <text>1 session per day for out-of-home respite;</text> </paragraph> <paragraph num="(2)"> <text>6 hours per day of community-based respite;</text> </paragraph> <paragraph num="(3)"> <text>24 overnight units of respite annually;</text> </paragraph> <paragraph num="(4)"> <text>2 types per day of expressive and experiential behavioral services; or</text> </paragraph> <paragraph num="(5)"> <text>1 MCRS assessment for the development of the initial crisis plan.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Intensive in-home services may not be reimbursed for the same day of service or on the same day of service as:</text> <paragraph num="(1)"> <text>Partial hospitalization/day treatment;</text> </paragraph> <paragraph num="(2)"> <text>Mobile crisis response services; or</text> </paragraph> <paragraph num="(3)"> <text>Other family therapies.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Out-of-home respite and community-based respite services may not be reimbursed for the same day of service or on the same day of service as:</text> <paragraph num="(1)"> <text>Residential rehabilitation;</text> </paragraph> <paragraph num="(2)"> <text>Therapeutic behavioral services; or</text> </paragraph> <paragraph num="(3)"> <text>Any other public mental health system respite services.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Out-of-home respite and community-based respite services do not include on-going day care or before or after school programs.</text> </paragraph> <paragraph num="G."> <text>Out-of-home respite and community based respite services may not be delivered to youth residing in Treatment Foster Care.</text> </paragraph> <paragraph num="H."> <text>No more than 25 percent of the family support organization’s claims in a 30-day period for family peer support may be telephonic for a participant or the participant’s family.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Payment Procedures."> <paragraph num="A."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall:</text> <paragraph num="(a)"> <text>Bill the ASO in accordance with the payment methodology specified in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Accept payment from the ASO as payment in full for the covered services rendered, and make no additional charge to the participant or any other party for these services; and</text> </paragraph> <paragraph num="(c)"> <text>Submit a request for payment in a manner approved by the Program, which includes a certification of the:</text> <paragraph num="(i)"> <text>Date or dates of service;</text> </paragraph> <paragraph num="(ii)"> <text>Participant's name and Medicaid number;</text> </paragraph> <paragraph num="(iii)"> <text>Provider's name, location, and provider identification number;</text> </paragraph> <paragraph num="(iv)"> <text>Type, procedure code or codes, and unit or units of covered services provided; and</text> </paragraph> <paragraph num="(v)"> <text>Amount of reimbursement requested.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Documentation Required.</text> <paragraph num="(1)"> <text>Payments by the Program or its designee may be withheld or recovered if the provider fails to submit:</text> <paragraph num="(a)"> <text>Requested evidence of services provided;</text> </paragraph> <paragraph num="(b)"> <text>Staff qualifications;</text> </paragraph> <paragraph num="(c)"> <text>Corrective action plans; or</text> </paragraph> <paragraph num="(d)"> <text>Any other types of documentation related to ensuring the health and safety of a participant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation.</text> </paragraph> <paragraph num="(3)"> <text>An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="D."> <text>Payments.</text> <paragraph num="(1)"> <text>Payments shall be made only for services rendered by a 1915(i) provider approved by the Department and enrolled as a Medicaid provider.</text> </paragraph> <paragraph num="(2)"> <text>Services will only be paid when delivered in accordance with the POC that has been authorized by the Department.</text> </paragraph> <paragraph num="(3)"> <text>The Program shall pay according to the fee-for-service schedule for each of the covered services, as set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Family peer support services as described in Regulation .09 of this chapter shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>For dates of service from July 1, 2022 through June 30, 2023:</text> <paragraph num="(a)"> <text>$21.65 per 15-minute unit for face-to-face services; or</text> </paragraph> <paragraph num="(b)"> <text>$10.82 per 15-minute unit for telephonic or other non-face-to-face activities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023:</text> <paragraph num="(a)"> <text>$22.30 per 15-minute unit for face-to-face services; or</text> </paragraph> <paragraph num="(b)"> <text>$11.84 per 15-minute unit for telephonic or other non-face-to-face activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Respite services as described in Regulation .10 of this chapter shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>July 1, 2022 through June 30, 2023:</text> <paragraph num="(a)"> <text>$34.12 per 1-hour unit of service for community-based respite services; or</text> </paragraph> <paragraph num="(b)"> <text>$270.46 per unit of out-of-home respite care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023:</text> <paragraph num="(a)"> <text>$35.14 per 1-hour unit of service for community-based respite services; or</text> </paragraph> <paragraph num="(b)"> <text>$278.57 per unit of out-of-home respite care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a licensed mental health professional, shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>For dates of service from July 1, 2022 through June 30, 2023</text> <paragraph num="(a)"> <text>For individual therapy:</text> <paragraph num="(i)"> <text>$92.77 per 45—50-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$121.55 per 75—80-minute session; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For group therapy:</text> <paragraph num="(i)"> <text>$36.87 per 45—60-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$47.95 per prolonged (75—90-minute) session.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023:</text> <paragraph num="(a)"> <text>For individual therapy:</text> <paragraph num="(i)"> <text>$95.55 per 45—50-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$125.20 per 75—80-minute session; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For group therapy:</text> <paragraph num="(i)"> <text>$37.98 per 45—60-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$49.39 per prolonged (75—90-minute) session.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a non-licensed mental health professional, shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>For dates of service from July 1, 2022 through June 30, 2023:</text> <paragraph num="(a)"> <text>For individual therapy:</text> <paragraph num="(i)"> <text>$84.33 per 45-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$109.64 per 75—80-minute session; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For group therapy:</text> <paragraph num="(i)"> <text>$32.78 per 45—60-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$42.59 per prolonged (75—90-minute) session.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023:</text> <paragraph num="(a)"> <text>For individual therapy:</text> <paragraph num="(i)"> <text>$86.86 per 45-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$112.93 per 75—80-minute session; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For group therapy:</text> <paragraph num="(i)"> <text>$33.76 per 45—60-minute session; or</text> </paragraph> <paragraph num="(ii)"> <text>$43.87 per prolonged (75—90-minute) session.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Intensive in-home services as described in Regulation .12 of this chapter shall be reimbursed at the following rates:</text> <paragraph num="(1)"> <text>For dates of service from July 1, 2022 through June 30, 2023:</text> <paragraph num="(a)"> <text>$337.54 per week of service for EBP-IIHS providers; or</text> </paragraph> <paragraph num="(b)"> <text>$267.78 per week of service for non-EBP IIHS providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2023:</text> <paragraph num="(a)"> <text>$347.67 per week of service for EBP-IIHS providers; or</text> </paragraph> <paragraph num="(b)"> <text>$275.81 per week of service for non-EBP IIHS providers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Recovery and Reimbursements."> <text>Recovery and reimbursement are set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08 and 10.21.10.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Appeal Procedures for Providers."> <text>Appeal procedures for providers are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Appeal Procedures for Applicants and Participants."> <text>Appeal procedures for applicants and participants are those set forth in COMAR 10.01.04, 10.09.24.13, and 10.09.70.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 2014 (41:19 Md. R. 1077)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective July 4, 2016 (43:13 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, E, H amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 14, 2021 (48:12 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D, E amended effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09F repealed effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E repealed effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C repealed effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12F repealed effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E—I adopted effective November 13, 2023 (50:22 Md. R. 974)</annotation> </annotations> </chapter> <chapter num="90" heading="Mental Health Case Management: Care Coordination for Children and Youth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to providers organized to deliver mental health case management services for children and youth.</text> </paragraph> <paragraph num="B."> <text>The purpose of mental health case management care coordination is to assist participants in gaining access to needed medical, mental health, social, educational, and other services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program defined in COMAR 10.09.89.</text> </paragraph> <paragraph num="(2)"> <text>“Care coordination” means services which assist participants in gaining access to a full range of behavioral health services and, as necessary, any medical, social, financial assistance, counseling, educational, housing, and other support services.</text> </paragraph> <paragraph num="(3)"> <text>“Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that:</text> <paragraph num="(a)"> <text>Are approved by the Department under this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements of COMAR 10.09.89 to provide care coordination to participants in the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Care coordinator” means an individual employed through the care coordination organization who is responsible for providing care management services to benefit participants and families, including, but not limited to:</text> <paragraph num="(a)"> <text>Coordination of child and family team meetings; and</text> </paragraph> <paragraph num="(b)"> <text>Completion of the initial and revised plan of care.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Child and family team (CFT)” means the group of individuals, including both formal and informal supports and inclusive of the youth and the youth’s family, responsible for the creation and implementation of the plan of care.</text> </paragraph> <paragraph num="(6)"> <text>“Co-occurring disorder” means a diagnosis based on the current Diagnostic and Statistical Manual published by the American Psychiatric Association where the participant is indicated as having both a mental illness and substance use disorder.</text> </paragraph> <paragraph num="(7)"> <text>“Core service agency” has the meaning stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="(8)"> <text>“Department” has the meaning stated in COMAR 10.09.36.01 and refers to the Department or its designee.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(10)"> <text>“Mental Health Case Management: Care Coordination for Children and Youth” has the same meaning as “care coordination” as defined in this regulation.</text> </paragraph> <paragraph num="(11)"> <text>“Mental health professional” has the meaning stated in COMAR 10.21.17.02.</text> </paragraph> <paragraph num="(12)"> <text>“Mental health services” means those services described in COMAR 10.09.70.</text> </paragraph> <paragraph num="(13)"> <text>“Minor” means a child or adolescent younger than 16 years old.</text> </paragraph> <paragraph num="(14)"> <text>“Natural supports” means any individual who plays a positive, but nonprofessional, role in someone’s plan of care.</text> </paragraph> <paragraph num="(15)"> <text>“Participant” means an individual who meets the qualifications for participation in care coordination that are specified in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(16)"> <text>“Plan of care (POC)” means the individualized plan for supports and services prepared according to the requirements outlined in this chapter for a specific participant in care coordination, including a POC developed for 1915(i) participants pursuant to COMAR 10.09.89.</text> </paragraph> <paragraph num="(17)"> <text>“Program” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(18)"> <text>“Provider” means the care coordination provider.</text> </paragraph> <paragraph num="(19)"> <text>“Recipient” has the meaning stated in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(20)"> <text>“Residential treatment center (RTC)” has the meaning stated in COMAR 10.07.04.</text> </paragraph> <paragraph num="(21)"> <text>“Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17.02.</text> </paragraph> <paragraph num="(22)"> <text>“Young adult” means an individual who is 18 years old or older but not older than 21 years old.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Participant Eligibility."> <paragraph num="A."> <text>A participant shall be eligible for care coordination services if the recipient:</text> <paragraph num="(1)"> <text>Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the criteria of either §B(1) or (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The participant:</text> <paragraph num="(1)"> <text>Shall:</text> <paragraph num="(a)"> <text>Meet the diagnostic requirements of being either:</text> <paragraph num="(i)"> <text>An individual younger than 18 years old with a serious emotional disturbance or co-occurring disorder; or</text> </paragraph> <paragraph num="(ii)"> <text>A young adult with a serious emotional disturbance or co-occurring disorder enrolled in care coordination services continuously under this chapter since reaching age 18; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Require community treatment and support in order to prevent or address:</text> <paragraph num="(i)"> <text>Inpatient psychiatric or substance use treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Treatment in a RTC or residential substance use treatment facility;</text> </paragraph> <paragraph num="(iii)"> <text>An out-of-home placement;</text> </paragraph> <paragraph num="(iv)"> <text>Emergency room utilization due to multiple behavioral health stressors;</text> </paragraph> <paragraph num="(v)"> <text>Homelessness or housing instability, or otherwise lacking in permanent, safe housing; or</text> </paragraph> <paragraph num="(vi)"> <text>Arrest or incarceration due to multiple behavioral health stressors; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall:</text> <paragraph num="(a)"> <text>Meet the requirements of §B(1)(a); and</text> </paragraph> <paragraph num="(b)"> <text>Need care coordination services to facilitate community treatment following:</text> <paragraph num="(i)"> <text>Release from a detention center or correctional facility; or</text> </paragraph> <paragraph num="(ii)"> <text>Discharge to the community from RTC placement or inpatient psychiatric unit.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A participant that disenrolls after reaching 18 years of age and wishes to re-enroll in care coordination services at a later date shall do so pursuant to COMAR 10.09.45 if more than 120 calendar days has passed since disenrollment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participant Eligibility — Levels of Intensity."> <paragraph num="A."> <text>In addition to meeting the eligibility criteria outlined under Regulation .03 of this chapter, participants shall be classified according to the levels of intensity listed in Regulation .05, 06, or .07 of this chapter, based on the severity of the participant’s behavioral health or co-occurring disorder, along with assessed strengths and needs.</text> </paragraph> <paragraph num="B."> <text>The Department or its designee shall review participant levels of care to confirm these are appropriate to the participants’ needs.</text> </paragraph> <paragraph num="C."> <text>Participants may not remain at Level III for longer than 6 consecutive months unless approved by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Eligibility — Level I — General Care Coordination."> <text>The participant as described in Regulation .03A of this chapter shall meet at least two of the following conditions:</text> <paragraph num="A."> <text>The participant is not linked to behavioral health, health insurance, or medical services;</text> </paragraph> <paragraph num="B."> <text>The participant lacks basic supports for education, income, shelter, or food;</text> </paragraph> <paragraph num="C."> <text>The participant is transitioning from one level of intensity to another level of intensity of services;</text> </paragraph> <paragraph num="D."> <text>The participant needs care coordination services to obtain and maintain community-based treatment and services;</text> </paragraph> <paragraph num="E."> <text>The participant:</text> <paragraph num="(1)"> <text>Is currently enrolled in Level II or Level III Care Coordination services under this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Has stabilized to the point that Level I is most appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Participant Eligibility — Level II — Moderate Care Coordination."> <text>The participant as described in Regulation .03A of this chapter shall meet three or more of the following conditions:</text> <paragraph num="A."> <text>The participant is not linked to behavioral health services, health insurance, or medical services;</text> </paragraph> <paragraph num="B."> <text>The participant lacks basic supports for education, income, food, or transportation;</text> </paragraph> <paragraph num="C."> <text>The participant is homeless or at-risk for homelessness;</text> </paragraph> <paragraph num="D."> <text>The participant is transitioning from one level of intensity to another level of intensity including transitions out of the following levels of service:</text> <paragraph num="(1)"> <text>Inpatient psychiatric or substance use services;</text> </paragraph> <paragraph num="(2)"> <text>RTC; or</text> </paragraph> <paragraph num="(3)"> <text>1915(i) services under COMAR 10.09.89;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Due to multiple behavioral health stressors within the past 12 months, the participant has a history of:</text> <paragraph num="(1)"> <text>Psychiatric hospitalizations; or</text> </paragraph> <paragraph num="(2)"> <text>Repeated visits or admissions to:</text> <paragraph num="(a)"> <text>Emergency room psychiatric units;</text> </paragraph> <paragraph num="(b)"> <text>Crisis beds; or</text> </paragraph> <paragraph num="(c)"> <text>Inpatient psychiatric units;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The participant needs care coordination services to obtain and maintain community-based treatment and services;</text> </paragraph> <paragraph num="G."> <text>The participant:</text> <paragraph num="(1)"> <text>Is currently enrolled in Level III Care Coordination services under this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Has stabilized to the point that Level II is most appropriate;</text> </paragraph> </paragraph> <paragraph num="H."> <text>The participant:</text> <paragraph num="(1)"> <text>Is currently enrolled in Level I Care Coordination services under this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Has experienced one of the following adverse childhood experiences during the preceding 6 months:</text> <paragraph num="(a)"> <text>Emotional, physical, or sexual abuse;</text> </paragraph> <paragraph num="(b)"> <text>Emotional or physical neglect; or</text> </paragraph> <paragraph num="(c)"> <text>Significant family disruption or stressors.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Participant Eligibility — Level III — Intensive Care Coordination."> <paragraph num="A."> <text>The participant shall meet at least one of the following conditions:</text> <paragraph num="(1)"> <text>The participant has been enrolled in the 1915(i) program for 6 months or less;</text> </paragraph> <paragraph num="(2)"> <text>The participant is currently enrolled in Level I or Level II Care Coordination services under this chapter and has experienced one of the following adverse childhood experiences during the preceding 6 months:</text> <paragraph num="(a)"> <text>Emotional, physical, or sexual abuse;</text> </paragraph> <paragraph num="(b)"> <text>Serious emotional or physical neglect; or</text> </paragraph> <paragraph num="(c)"> <text>Significant family disruption or stressors;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The participant meets the following conditions:</text> <paragraph num="(a)"> <text>The participant has a behavioral health disorder amenable to active clinical treatment, diagnosed through a face-to-face psychosocial assessment by a licensed mental health professional;</text> </paragraph> <paragraph num="(b)"> <text>There is clinical evidence the minor has a SED and continues to meet the service intensity needs and medical necessity criteria for the duration of their enrollment;</text> </paragraph> <paragraph num="(c)"> <text>A comprehensive psychosocial assessment performed by a licensed mental health professional finds that the participant exhibits a significant impairment in functioning, representing potential serious harm to self or others, across settings, including the home, school, or community;</text> </paragraph> <paragraph num="(d)"> <text>The psychosocial assessment supports the completion of the Early Childhood Service Intensity Instrument (ECSII) for youth ages 0—5 or the Child and Adolescent Service Intensity Instrument (CASII) for youth ages 6—21, by which the participant receives a score of:</text> <paragraph num="(i)"> <text>3 on the ECSII; or</text> </paragraph> <paragraph num="(ii)"> <text>3 or higher on the CASII;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Youth with a score of 3, 4, or 5 on the CASII also shall meet the conditions outlined in §B of this regulation; and</text> </paragraph> <paragraph num="(f)"> <text>Youth with a score of 3 or 4 on the ECSII also shall meet the conditions outlined in §C of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Youth with a score of 3, 4, or 5 on the CASII shall meet one of the following criteria to be eligible based on their impaired functioning and service intensity level:</text> <paragraph num="(1)"> <text>Transitioning from a residential treatment center; or</text> </paragraph> <paragraph num="(2)"> <text>Living in the community, be 6 through 21 years old, and have:</text> <paragraph num="(a)"> <text>Any combinations of 2 or more inpatient psychiatric hospitalizations or emergency room visits in the past 12 months; or</text> </paragraph> <paragraph num="(b)"> <text>Been in an RTC within the past 90 calendar days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Youth who are younger than 6 years old who have a score of a 3 or 4 on the ECSII shall either:</text> <paragraph num="(1)"> <text>Be referred directly from one of the following:</text> <paragraph num="(a)"> <text>Inpatient or day hospital unit;</text> </paragraph> <paragraph num="(b)"> <text>Primary care physician (PCP);</text> </paragraph> <paragraph num="(c)"> <text>Outpatient psychiatric facility;</text> </paragraph> <paragraph num="(d)"> <text>Early Childhood Mental Health (ECMH) Consultation program in daycare;</text> </paragraph> <paragraph num="(e)"> <text>Head Start program;</text> </paragraph> <paragraph num="(f)"> <text>Judy Hoyer Center; or</text> </paragraph> <paragraph num="(g)"> <text>Home visiting program; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If living in the community, meet one or more of the following criteria in the past 12 months:</text> <paragraph num="(a)"> <text>Had one or more psychiatric inpatient or day hospitalizations;</text> </paragraph> <paragraph num="(b)"> <text>Had one or more ER visits;</text> </paragraph> <paragraph num="(c)"> <text>Exhibit severe aggression;</text> </paragraph> <paragraph num="(d)"> <text>Display dangerous behavior;</text> </paragraph> <paragraph num="(e)"> <text>Been suspended from school or childcare setting;</text> </paragraph> <paragraph num="(f)"> <text>Display emotional or behavioral disturbance prohibiting their care by anyone other than their primary caregiver;</text> </paragraph> <paragraph num="(g)"> <text>Be at risk for out-of-home placement or placement disruption;</text> </paragraph> <paragraph num="(h)"> <text>Have severe temper tantrums that place the child or family members at risk of harm;</text> </paragraph> <paragraph num="(i)"> <text>Have trauma exposures and other adverse life events; or</text> </paragraph> <paragraph num="(j)"> <text>Be at risk of family-related risk factors, including safety, parent-child relational conflict, and poor health and developmental outcomes.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Conditions for Provider Participation."> <paragraph num="A."> <text>Selection of CCOs.</text> <paragraph num="(1)"> <text>The local core service agencies shall select child and youth CCOs through a competitive procurement process, at least once every 5 years.</text> </paragraph> <paragraph num="(2)"> <text>Regional CCOs may be procured at the mutual agreement of local core service agencies so long as the local core service agencies demonstrate that there is sufficient provider capacity to serve the children and youth in a particular region.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The CCO shall:</text> <paragraph num="(1)"> <text>Be approved by the Department as a CCO;</text> </paragraph> <paragraph num="(2)"> <text>Commit to coordination with all agencies involved in the participant’s POC; and</text> </paragraph> <paragraph num="(3)"> <text>Work with the State and local child- and family-serving agencies to develop a network of clinical and natural supports in the community to address strengths and needs identified in each POC.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and individuals providing care coordination services to participants and their families:</text> <paragraph num="(1)"> <text>Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Request that DPSCS send the report to:</text> <paragraph num="(a)"> <text>The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or</text> </paragraph> <paragraph num="(b)"> <text>The Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Review the results of the background checks;</text> </paragraph> <paragraph num="(4)"> <text>Store background checks in a secure manner consistent with State and federal law; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prohibitions Against Utilization of Staff. Unless waived by the Department in accordance with §E of this regulation, the provider shall prohibit from working with the participant or the participant’s family any staff, volunteers, students, or individuals who:</text> <paragraph num="(1)"> <text>Are convicted of, received probation before judgment for, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft or have any other criminal history that indicates behavior which is potentially harmful to a participant;</text> </paragraph> <paragraph num="(2)"> <text>Are cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect; or</text> </paragraph> <paragraph num="(3)"> <text>Have an indicated finding of child abuse or neglect.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that:</text> <paragraph num="(1)"> <text>For criminal background checks:</text> <paragraph num="(a)"> <text>The conviction of, the probation before judgment for, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application;</text> </paragraph> <paragraph num="(b)"> <text>The criminal history does not indicate behavior that is potentially harmful to participants; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For abuse and neglect findings:</text> <paragraph num="(a)"> <text>The indicated finding occurred more than 7 years before the date of the clearance request;</text> </paragraph> <paragraph num="(b)"> <text>The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The CCO shall provide all three levels of care coordination to ensure continuity of care for participants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Conditions for Provider Participation — Eligibility."> <paragraph num="A."> <text>General Requirements. To be eligible to be approved as a care coordination organization, an entity shall meet all of the:</text> <paragraph num="(1)"> <text>Conditions for participation as set forth in COMAR 10.09.36.03; and</text> </paragraph> <paragraph num="(2)"> <text>Medical Assistance provisions listed in COMAR designated for their provider type.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific Requirements. A CCO:</text> <paragraph num="(1)"> <text>May not place restrictions on the qualified recipient’s right to elect to or decline to:</text> <paragraph num="(a)"> <text>Receive care coordination as authorized by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Choose a care coordinator, as approved by the Department, and other care providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall employ appropriately qualified individuals as care coordinators, and care coordinator supervisors with relevant work experience, including experience with the populations of focus, including but not limited to:</text> <paragraph num="(a)"> <text>Youth younger than 18 years old with a serious emotional disturbance or co-occurring disorder; and</text> </paragraph> <paragraph num="(b)"> <text>Young adults with a serious emotional disturbance or co-occurring disorder;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Shall assign care coordinators to the participant and family;</text> </paragraph> <paragraph num="(4)"> <text>Shall schedule a face-to-face meeting with the participant and family within 72 hours of notification of the participant’s enrollment in Care Coordination services;</text> </paragraph> <paragraph num="(5)"> <text>Shall convene the first CFT meeting within 30 calendar days of notification of enrollment to begin developing the POC;</text> </paragraph> <paragraph num="(6)"> <text>Shall collect information gathered during the application process including results from the physical examination, psychosocial and psychiatric screening, assessments, evaluations, and information from the CFT, participant, and family, and the identified supports to be incorporated as a part of POC development process;</text> </paragraph> <paragraph num="(7)"> <text>For 1915(i) participants:</text> <paragraph num="(a)"> <text>Shall arrange for the participant and family to meet with peer support partners within 30 calendar days of notification of enrollment to allow the participant and family the opportunity to determine the role of peer support in the development and implementation of the POC; and</text> </paragraph> <paragraph num="(b)"> <text>Shall arrange for the participant and family to meet with the intensive in-home service (IIHS) to develop the initial crisis plan within 1 week of enrollment in the 1915(i);</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Shall assure that:</text> <paragraph num="(a)"> <text>A participant’s initial assessment is completed within 10 calendar days after the participant has been authorized by Department and determined eligible for, and has elected to receive, care coordination services; and</text> </paragraph> <paragraph num="(b)"> <text>An initial POC is completed within 15 calendar days after completion of the initial assessment;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Shall maintain an electronic health record for each participant which includes all of the following:</text> <paragraph num="(a)"> <text>An initial referral and intake form with identifying information, including, but not limited to, the individual’s name and Medicaid identification number;</text> </paragraph> <paragraph num="(b)"> <text>A written agreement for services signed by the participant or the participant’s legally authorized representative and by the participant’s care coordinator;</text> </paragraph> <paragraph num="(c)"> <text>An assessment as specified in Regulation .07of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>A POC as specified in Regulation .07D—E of this chapter;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Shall have formal written policies and procedures, approved by the Department, or the Department’s designee, which specifically address the provision of care coordination to participants in accordance with the requirements of this chapter;</text> </paragraph> <paragraph num="(11)"> <text>Shall be available to participants and, as appropriate, their families or, if the participant is a minor, the minor’s parent or guardian, for 24 hours a day, 7 calendar days a week, in order to refer:</text> <paragraph num="(a)"> <text>Participants to needed services and supports; and</text> </paragraph> <paragraph num="(b)"> <text>In the case of a behavioral health emergency, participants to behavioral health treatment and evaluation services in order to divert the participant’s admission to a higher level of care;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Shall document in the participant’s care coordination records if the participant declines care coordination services or if a service is terminated because it was not working;</text> </paragraph> <paragraph num="(13)"> <text>May not provide other services to participants unless the Department approves how conflict of interest standards would be safely addressed.</text> </paragraph> <paragraph num="(14)"> <text>Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants;</text> </paragraph> <paragraph num="(15)"> <text>Shall maintain information on current resources for behavioral health, medical, social, financial assistance, vocational, educational, housing, and other support services including informal community resources;</text> </paragraph> <paragraph num="(16)"> <text>Shall safeguard the confidentiality of the participant’s records in accordance with State and federal laws and regulations governing confidentiality;</text> </paragraph> <paragraph num="(17)"> <text>Shall comply with the Department’s fiscal and program reporting requirements and submit reports to the Department in the manner specified by the Department;</text> </paragraph> <paragraph num="(18)"> <text>Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual’s access to other services;</text> </paragraph> <paragraph num="(19)"> <text>Shall assure the amount, duration, and scope of the care coordination activities are documented in a participant’s POC, which includes care coordination activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community; and</text> </paragraph> <paragraph num="(20)"> <text>Shall commit to coordinating with all agencies involved in the participant’s POC.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Mental Health Case Management Care Coordination Provider Staff."> <text>CCOs are required to maintain the following positions:</text> <paragraph num="A."> <text>Care coordinator supervisor who:</text> <paragraph num="(1)"> <text>Is a mental health professional with a minimum of a Master’s degree and who is licensed and legally authorized to practice under Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of:</text> <paragraph num="(a)"> <text>Social work;</text> </paragraph> <paragraph num="(b)"> <text>Professional Counseling;</text> </paragraph> <paragraph num="(c)"> <text>Psychology;</text> </paragraph> <paragraph num="(d)"> <text>Nursing; or</text> </paragraph> <paragraph num="(e)"> <text>Medicine;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has a minimum of 1 year of experience in behavioral health working as a supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Has a minimum of 1 year of experience working with children and youth with mental health or co-occurring disorders;</text> </paragraph> <paragraph num="(4)"> <text>Provides clinical consultation and training to care coordinators regarding mental health or co-occurring disorders;</text> </paragraph> <paragraph num="(5)"> <text>Provides supervision of the POCs, and consultation to the CFT meetings, as needed;</text> </paragraph> <paragraph num="(6)"> <text>Is employed or contracted at a ratio of one supervisor to no more than eight care coordinators; and</text> </paragraph> <paragraph num="(7)"> <text>Meets training and certification requirements for care coordinator supervisors, as set by the Department; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Care coordinator who:</text> <paragraph num="(1)"> <text>Has at least a:</text> <paragraph num="(a)"> <text>Bachelor’s degree and has met the Department’s training requirements for care coordinators, or</text> </paragraph> <paragraph num="(b)"> <text>High school diploma or equivalency and is 21 years old or older and was a participant in, or is a direct caregiver, or was a direct caregiver of an individual who received services from the public and child- and family-serving system and meets the training and certification requirements for care coordinators as set forth by the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is employed by the CCO to provide care coordination services to participants; and</text> </paragraph> <paragraph num="(3)"> <text>Provides management of the POC and facilitation of the CFT meetings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Covered Services."> <paragraph num="A."> <text>The Department shall reimburse for the care coordination services in this regulation when these services have been documented, pursuant to the requirements of this chapter, as necessary.</text> </paragraph> <paragraph num="B."> <text>Care coordination services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities.</text> </paragraph> <paragraph num="C."> <text>Care coordination may include contacts that are directly related to identifying the needs and supports for helping the participant to access services.</text> </paragraph> <paragraph num="D."> <text>The CCO shall engage in participant advocacy, including:</text> <paragraph num="(1)"> <text>Empowering the participant and, if the participant is a minor, the minor’s parent or guardian to secure needed services;</text> </paragraph> <paragraph num="(2)"> <text>Taking any necessary actions to secure services on the participant’s behalf; and</text> </paragraph> <paragraph num="(3)"> <text>Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals or, if the participant is a minor, encouraging the parent or guardian to carry out these decisions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Comprehensive Participant Assessment and Periodic Participant Reassessment.</text> <paragraph num="(1)"> <text>Providers shall use a child and youth assessment tool approved by the Department to perform participant assessments and reassessments.</text> </paragraph> <paragraph num="(2)"> <text>Initial assessment or reassessment involves the participant’s stated needs and review of information concerning the participant’s mental health, social, familial, educational, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a POC.</text> </paragraph> <paragraph num="(3)"> <text>The initial assessment or reassessment of the participant’s needs and progress shall be facilitated by the care coordinator and monitored by the CFT, which includes the participant, family members, and friends of the participant, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, and community service providers, such as mental health providers, medical providers, social workers, and educators, as appropriate.</text> </paragraph> <paragraph num="(4)"> <text>Coordination and Facilitation of the CFT. The care coordinator shall:</text> <paragraph num="(a)"> <text>Identify a location for the CFT meetings that is suitable to the participant’s needs;</text> </paragraph> <paragraph num="(b)"> <text>Convene the CFT at least every 6 months, or more frequently, as clinically necessary; and</text> </paragraph> <paragraph num="(c)"> <text>For 1915(i) participants, convene as per the timeline and functions pursuant to COMAR 10.09.89.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>After an initial assessment, each participant shall be reassessed at a minimum of every 6 months.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Development and Periodic Revision of the POC.</text> <paragraph num="(1)"> <text>After the initial assessment is completed, a POC shall be developed based on the information obtained through the comprehensive screening and assessment tools approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The CCO shall finalize the POC within 30 calendar days of notification of enrollment and submit it to the Department or its designee.</text> </paragraph> <paragraph num="(3)"> <text>Development of and updates to the POC shall be youth- and family-directed and managed through CFT meetings.</text> </paragraph> <paragraph num="(4)"> <text>The POC shall meet the requirements of Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>The POC development process shall include:</text> <paragraph num="(a)"> <text>The CFT meeting, which includes the participant, and if the participant is a minor, the minor’s parent or guardian, providers, family members, and other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the POC;</text> </paragraph> <paragraph num="(b)"> <text>The development of the written, individualized POC based on the participant’s strengths, needs, and progress toward outcome measures;</text> </paragraph> <paragraph num="(c)"> <text>Transitional care planning that involves contact with the participant or, if the participant is a minor, the minor’s parent or guardian, or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and</text> </paragraph> <paragraph num="(d)"> <text>Discharge planning from care coordination, when appropriate and when the family is closer to its identified vision, when family needs have been met, and when outcome measures for care coordination have been achieved.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>After the POC is developed, the CCO shall update the POC as often as clinically indicated based on the strengths and needs of the participant but not less than:</text> <paragraph num="(a)"> <text>For Level I participants, every 6 months;</text> </paragraph> <paragraph num="(b)"> <text>For Level II participants, every 3 months;</text> </paragraph> <paragraph num="(c)"> <text>For Level III participants, every 45 calendar days; and</text> </paragraph> <paragraph num="(d)"> <text>For all participants, within 7 calendar days following a crisis event.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Covered Services — Plan of Care."> <paragraph num="A."> <text>The POC shall contain, at minimum:</text> <paragraph num="(1)"> <text>A description of the participant’s strengths and needs;</text> </paragraph> <paragraph num="(2)"> <text>The diagnosis or diagnoses established as evidence of the participant’s eligibility for services under this chapter;</text> </paragraph> <paragraph num="(3)"> <text>The goals of care coordination services to address the behavioral health, medical, social, educational, and other services needed by the participant, with expected target completion dates;</text> </paragraph> <paragraph num="(4)"> <text>A crisis plan including the proposed strategies and interventions for preventing and responding to crises and the youth and family’s definitions of what constitutes a crisis;</text> </paragraph> <paragraph num="(5)"> <text>Designation of the care coordinator with primary responsibility for implementation of the POC;</text> </paragraph> <paragraph num="(6)"> <text>Signatures of the care coordinator and other CFT members, if appropriate;</text> </paragraph> <paragraph num="(7)"> <text>Signatures of the participant and family indicating that the participant and family have:</text> <paragraph num="(a)"> <text>Participated in the development of the POC; and</text> </paragraph> <paragraph num="(b)"> <text>Had choice in the selection of services, providers, and interventions when possible, in the care coordination process of building the POC; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>For 1915(i) participants, specified for each recommended service, the following information as appropriate or as required by the Department:</text> <paragraph num="(a)"> <text>Description of the service;</text> </paragraph> <paragraph num="(b)"> <text>Service start date;</text> </paragraph> <paragraph num="(c)"> <text>Estimated duration;</text> </paragraph> <paragraph num="(d)"> <text>Frequency and units of service as measured in 15 minute increments to be delivered;</text> </paragraph> <paragraph num="(e)"> <text>The specific need or goal that the service is related to; and</text> </paragraph> <paragraph num="(f)"> <text>The provider name and contact information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If not included in the POC, an ongoing record of contacts made on the participant’s behalf, which includes all of the following, shall be included in the participant’s chart:</text> <paragraph num="(1)"> <text>Date, start and end time, and subject of contact;</text> </paragraph> <paragraph num="(2)"> <text>Individual contacted;</text> </paragraph> <paragraph num="(3)"> <text>Electronic or scanned signature of care coordinator making the contact;</text> </paragraph> <paragraph num="(4)"> <text>Nature, content, and unit or units of service provided;</text> </paragraph> <paragraph num="(5)"> <text>Place of service;</text> </paragraph> <paragraph num="(6)"> <text>Whether strategies and tasks specified in the POC have been achieved;</text> </paragraph> <paragraph num="(7)"> <text>The timeline for obtaining needed services;</text> </paragraph> <paragraph num="(8)"> <text>The timeline for reevaluation of the plan;</text> </paragraph> <paragraph num="(9)"> <text>The need for and occurrences of coordination with child- and family-serving agencies and providers;</text> </paragraph> <paragraph num="(10)"> <text>The names and contact information for the participant’s primary care provider, dentist, and other health care providers;</text> </paragraph> <paragraph num="(11)"> <text>The medications that the participant is currently taking and the dosage and frequency of the medications; and</text> </paragraph> <paragraph num="(12)"> <text>Monthly summary notes, which reflect progress made towards the identified needs and outcome measures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Covered Services — Child and Family Team Meetings."> <text>The CCO shall:</text> <paragraph num="A."> <text>Coordinate and facilitate the CFT, with CFT meetings convened at least every 45 calendar days or more frequently as clinically indicated;</text> </paragraph> <paragraph num="B."> <text>Record and keep notes at every CFT meeting that include the CFT members who were present, a summary of the discussion, any changes to the POC, and action items for follow up, and share them with the CFT members, including those who were not in attendance;</text> </paragraph> <paragraph num="C."> <text>Update the POC to include change in progress, services, or other areas within 5 calendar days of the CFT meeting; and</text> </paragraph> <paragraph num="D."> <text>Ensure that the care coordinator:</text> <paragraph num="(1)"> <text>Facilitates CFT meetings;</text> </paragraph> <paragraph num="(2)"> <text>Facilitates access to the services and supports in the POC; and</text> </paragraph> <paragraph num="(3)"> <text>At the first meeting:</text> <paragraph num="(a)"> <text>Administers the appropriate assessments, as designated by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Works with the participant and family to develop an initial crisis plan that includes response to immediate service needs; and</text> </paragraph> <paragraph num="(c)"> <text>For 1915(i) participants, provides an overview of the care coordination process.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Covered Services — Referral and Related Activities."> <paragraph num="A."> <text>The care coordinator shall ensure that the participant or, if the participant is a minor, the minor’s parent or guardian has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention.</text> </paragraph> <paragraph num="B."> <text>The care coordinator shall take the necessary action as defined by the Department when the services identified under Regulation .13 of this chapter have not occurred.</text> </paragraph> <paragraph num="C."> <text>The linkage process shall include:</text> <paragraph num="(1)"> <text>Community and natural support development by contacting, with the participant’s consent, members of the participant’s support network, including CFT members, for example, family, friends, and neighbors, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, to mobilize assistance for the participant;</text> </paragraph> <paragraph num="(2)"> <text>Crisis intervention by referral of the participant or, if the participant is a minor, the minor’s parent or guardian, to services on an emergency basis when immediate intervention is necessary;</text> </paragraph> <paragraph num="(3)"> <text>Arranging for the participant’s transportation to and from services;</text> </paragraph> <paragraph num="(4)"> <text>Outreach in an attempt to locate service providers which can meet the participant’s needs, or, if the participant is a minor, the minor’s parent or guardian’s needs;</text> </paragraph> <paragraph num="(5)"> <text>Reviewing the POC with the participant and the participant’s CFT, as appropriate, or, if the participant is a minor, with the minor’s parent or guardian, so as to enable and facilitate their participation in the plan’s implementation; and</text> </paragraph> <paragraph num="(6)"> <text>Provision of health and wellness education, information, and linkages to high-quality health care services, preventive and health promotion resources, and chronic disease management services with an emphasis on resources available in the family’s community and peer group.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Covered Services — Monitoring and Follow-Up Activities."> <paragraph num="A."> <text>A CCO shall monitor, as per standards set forth by the Department, the activities and contacts that are considered necessary to ensure the POC is implemented and adequately addresses the participant’s needs, and include:</text> <paragraph num="(1)"> <text>The participant or, if the participant is a minor, the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>With proper consent:</text> <paragraph num="(a)"> <text>Family members and friends, if appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Other individuals or agency representatives identified and approved as CFT members by the participant or, if the participant is a minor, the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(c)"> <text>Other service providers, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The CCO shall:</text> <paragraph num="(1)"> <text>Follow up any service referral within 7 calendar days to determine whether the participant, or, if the participant is a minor, the minor’s parent or guardian, made contact with the service provider that the participant was referred to; and</text> </paragraph> <paragraph num="(2)"> <text>Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals, or, if the participant is a minor, the parent’s or guardian’s stated needs and goals for the participant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The CCO shall, in accordance with the decisions and recommendations of the CFT, revise the POC to reflect the participant’s changing needs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Limitations."> <paragraph num="A."> <text>Care coordination services are facilitative in nature.</text> </paragraph> <paragraph num="B."> <text>A restriction may not be placed on a qualified recipient’s option to receive mental health case management services.</text> </paragraph> <paragraph num="C."> <text>Care coordination services do not restrict or otherwise affect:</text> <paragraph num="(1)"> <text>Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The freedom of a participant or, if the participant is a minor, the minor’s parent or guardian to select from all available services for which the participant is found to be eligible; or</text> </paragraph> <paragraph num="(3)"> <text>A participant’s free choice among qualified providers or, if the participant is a minor, the minor’s parent or guardian’s free choice among qualified providers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The CCO may not bill the Program for:</text> <paragraph num="(1)"> <text>The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred;</text> </paragraph> <paragraph num="(2)"> <text>Activities integral to the administration of foster care programs;</text> </paragraph> <paragraph num="(3)"> <text>Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109—171);</text> </paragraph> <paragraph num="(4)"> <text>Activities for which third parties are liable to pay;</text> </paragraph> <paragraph num="(5)"> <text>Activities delivered as part of institutional discharge planning; or</text> </paragraph> <paragraph num="(6)"> <text>A 15-minute unit of service for telephonic contact, unless the provider has delivered at least 8 minutes of service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement may not be made for care coordination services if the participant is receiving a comparable care coordination service under another Program authority.</text> </paragraph> <paragraph num="F."> <text>A participant’s care coordinator may not be the participant’s family member or a direct service provider for the participant.</text> </paragraph> <paragraph num="G."> <text>Units of services for all levels of care coordination shall be 15 minutes of contact, which may include face-to-face and, with the exception of §G(4) of this regulation, non-face-to-face contacts with the participant, or, if the participant is a minor, with the minor’s parent or guardian, and indirect collateral contacts on behalf of the participant with other community providers, as per the following:</text> <paragraph num="(1)"> <text>For participants in Level I — General Coordination, allows a maximum of 12 units of service per month, with a minimum of two units of face-to-face contact;</text> </paragraph> <paragraph num="(2)"> <text>For participants in Level II — Moderate Care Coordination, allows a maximum of 30 units of service per month, with a minimum of four units of face-to-face contact;</text> </paragraph> <paragraph num="(3)"> <text>For participants in Level III — Intensive Care Coordination, allows a maximum of 60 units of service per month, with a minimum of six units of face-to-face contact; and</text> </paragraph> <paragraph num="(4)"> <text>For Level I and Level II, four additional units of service above and beyond the monthly maximum may be billed during the first month of service to the participant and every 6 months thereafter to allow for comprehensive assessment and reassessment of the participant, which shall be performed as a face-to-face service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Preauthorization."> <text>All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07 and COMAR 10.09.89 for services delivered to 1915(i) participants.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Payment Procedures."> <paragraph num="A."> <text>The Program shall reimburse the provider according to the requirements in this chapter and COMAR 10.09.89 for services delivered to 1915(i) participants, and the fees established under COMAR 10.21.25.</text> </paragraph> <paragraph num="B."> <text>Request for Payment.</text> <paragraph num="(1)"> <text>A provider shall submit requests for payment of mental health case management services according to procedures established by the Department.</text> </paragraph> <paragraph num="(2)"> <text>A provider shall bill the Program for the appropriate fee under COMAR 10.21.25.</text> </paragraph> <paragraph num="(3)"> <text>The Program may not make direct payment to recipients.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Minutes of service and units per participant are to be totaled by day and by service.</text> </paragraph> <paragraph num="D."> <text>Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="E."> <text>Payment shall be made:</text> <paragraph num="(1)"> <text>Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>According to the requirements of this chapter and COMAR 10.09.89 for 1915(i) participants, and the fees established in COMAR 10.21.25.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Service Provision. Units of services for all levels of care coordination shall be 15 minutes of contact, which may include:</text> <paragraph num="(1)"> <text>Face-to-face and non-face-to-face contacts with the participant or, if the participant is a minor, with the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>Indirect collateral contacts on behalf of the participant with other community providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Appeal Procedures."> <text>Appeal procedures are those set forth in COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".22" heading="Interpretive Regulation."> <text>State regulations are interpreted as those set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 2014 (41:19 Md. R. 1078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D amended effective August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16D amended effective April 13, 2015 (42:7 Md. R. 568)</annotation> </annotations> </chapter> <chapter num="91" heading="Hospital Presumptive Eligibility"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter establishes requirements for the determination of presumptive eligibility by qualified hospitals effective October 1, 2014.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has applied for presumptive eligibility at a participating hospital.</text> </paragraph> <paragraph num="(2)"> <text>“Application” means the presumptive eligibility application.</text> </paragraph> <paragraph num="(3)"> <text>“Authorized representative” has the same meaning as set forth in COMAR 10.01.04.01.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(5)"> <text>“Determination” means a decision regarding an applicant’s presumptive eligibility.</text> </paragraph> <paragraph num="(6)"> <text>“Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2).</text> </paragraph> <paragraph num="(7)"> <text>“Former foster care” means an individual who:</text> <paragraph num="(a)"> <text>Is younger than 26 years old;</text> </paragraph> <paragraph num="(b)"> <text>Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and</text> </paragraph> <paragraph num="(c)"> <text>Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance:</text> <paragraph num="(i)"> <text>On attaining age 18 and leaving out-of-home placement; or</text> </paragraph> <paragraph num="(ii)"> <text>On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Hospital” means an institution which:</text> <paragraph num="(a)"> <text>Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses.</text> </paragraph> <paragraph num="(10)"> <text>“Incarcerated inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5B.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals.</text> </paragraph> <paragraph num="(12)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq.</text> </paragraph> <paragraph num="(13)"> <text>“Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by participating hospitals in accordance with these regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements."> <paragraph num="A."> <text>A hospital eligible to make presumptive eligibility decisions shall:</text> <paragraph num="(1)"> <text>Participate as a Maryland Medical Assistance Program provider in good standing; and</text> </paragraph> <paragraph num="(2)"> <text>Sign an agreement prepared by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The agreement required under §A of this regulation shall require that the hospital:</text> <paragraph num="(1)"> <text>Comply with Departmental policies and procedures supplied by the Department at the time of application and training;</text> </paragraph> <paragraph num="(2)"> <text>Meet accuracy and timeliness standards established by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Submit a list to the Department of hospital employees who will attend presumptive eligibility training developed by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Prohibit employees who have not attended required trainings and passed a post-training test to make presumptive eligibility decisions; and</text> </paragraph> <paragraph num="(5)"> <text>Report all requested information on a form designated by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before assisting an applicant in filing a presumptive eligibility application, the hospital employee shall:</text> <paragraph num="(1)"> <text>Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(2)"> <text>Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application;</text> </paragraph> <paragraph num="(3)"> <text>Determine that the applicant has not:</text> <paragraph num="(a)"> <text>Had a prior presumptive eligibility period within the last 12 months for the individual other than pregnant women; or</text> </paragraph> <paragraph num="(b)"> <text>Had a prior presumptive eligibility period during the current pregnancy for a pregnant woman.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The hospital employee shall fill out the presumptive eligibility application based on information supplied by the applicant.</text> </paragraph> <paragraph num="E."> <text>The hospital employee shall make a presumptive eligibility decision and sign the presumptive eligibility application based on the following information obtained pursuant to COMAR 10.09.91.05:</text> <paragraph num="(1)"> <text>Residency;</text> </paragraph> <paragraph num="(2)"> <text>Citizenship;</text> </paragraph> <paragraph num="(3)"> <text>Family size and composition; and</text> </paragraph> <paragraph num="(4)"> <text>Gross family income.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The hospital employee shall inform the individual in writing of the hospital’s presumptive eligibility decision which includes an explanation of the presumptive eligibility period.</text> </paragraph> <paragraph num="G."> <text>The hospital shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage.</text> </paragraph> <paragraph num="H."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Keep all written and signed presumptive eligibility applications on file for 6 years; and</text> </paragraph> <paragraph num="(2)"> <text>Make the file available to the Department upon request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Hospital or Hospital Staff Disqualifications."> <paragraph num="A."> <text>A hospital qualified to make presumptive eligibility decisions shall:</text> <paragraph num="(1)"> <text>Make presumptive eligibility determinations in accordance with established Departmental policies and procedures; and</text> </paragraph> <paragraph num="(2)"> <text>Disqualify individual hospital employees who do not follow established Departmental regulations, policies and procedures.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon a finding that a qualified hospital has failed to meet the requirements of §A of this regulation, the Department shall provide the hospital with additional training or take other reasonable corrective action measures to address the noncompliance.</text> </paragraph> <paragraph num="C."> <text>If the remedial measures taken pursuant to §B of this regulation fail to provide a satisfactory resolution, the Department shall disqualify the hospital from making presumptive eligibility determinations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Criteria."> <paragraph num="A."> <text>An individual, the individual’s guardian, or a representative of the individual with personal knowledge shall apply for presumptive eligibility through a participating hospital.</text> </paragraph> <paragraph num="B."> <text>An individual, the individual’s guardian, or a representative of the individual with personal knowledge who applies for presumptive eligibility shall attest to:</text> <paragraph num="(1)"> <text>The citizenship requirements in COMAR 10.09.24.05;</text> </paragraph> <paragraph num="(2)"> <text>The residency requirements in COMAR 10.09.24.05-3;</text> </paragraph> <paragraph num="(3)"> <text>The individual’s pregnancy status;</text> </paragraph> <paragraph num="(4)"> <text>The individual’s family size; and</text> </paragraph> <paragraph num="(5)"> <text>The individual’s household’s gross monthly income.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Populations Eligible."> <text>Presumptive eligibility may be established for the following eligibility groups:</text> <paragraph num="A."> <text>Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level;</text> </paragraph> <paragraph num="B."> <text>Pregnant women whose income is equal to or less than 250 percent of the federal poverty level;</text> </paragraph> <paragraph num="C."> <text>Adults without dependent children who are older than 19 years old and younger than 65 years old, whose household income is equal to or less than 133 percent of the federal poverty level;</text> </paragraph> <paragraph num="D."> <text>Children who are younger than 19 years old who are under 300 percent of the federal poverty level; or</text> </paragraph> <paragraph num="E."> <text>Former foster care individuals who are younger than 26 years old.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <text>An individual may not apply for presumptive eligibility in Maryland if the individual:</text> <paragraph num="A."> <text>Is currently enrolled in the Maryland Medical Assistance Program or Medicare;</text> </paragraph> <paragraph num="B."> <text>Is an incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5B;</text> </paragraph> <paragraph num="C."> <text>Had a prior presumptive eligibility period during the last 12 months with the exception of pregnant women;</text> </paragraph> <paragraph num="D."> <text>Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or</text> </paragraph> <paragraph num="E."> <text>Does not meet the citizenship requirements stated in COMAR 10.09.24.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Certification Period."> <paragraph num="A."> <text>Presumptive eligibility begins on the day the hospital determines that the individual is presumptively eligible.</text> </paragraph> <paragraph num="B."> <text>Presumptive eligibility ends on the earlier of:</text> <paragraph num="(1)"> <text>The day in which the individual is determined eligible for Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>The last day of the month following the month in which the hospital determined presumptive eligibility, if:</text> <paragraph num="(a)"> <text>An individual is found ineligible for Medical Assistance; or</text> </paragraph> <paragraph num="(b)"> <text>An individual failed to apply for Medical Assistance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A non-pregnant individual may be determined presumptively eligible once per a 12-month period.</text> </paragraph> <paragraph num="D."> <text>A pregnant individual may be determined presumptively eligible once per pregnancy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Presumptive Eligibility Appeal Rights."> <text>An individual or an organization does not have appeal rights for presumptive eligibility determinations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-105(b), and 15-103, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2014 (41:25 Md. R. 1485)</annotation> </annotations> </chapter> <chapter num="92" heading="Acute Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care.</text> </paragraph> <paragraph num="(2)"> <text>“Acute level of care” means care in which a patient is treated:</text> <paragraph num="(a)"> <text>For a brief but severe episode of illness, for conditions that are the result of disease or trauma; and</text> </paragraph> <paragraph num="(b)"> <text>During recovery from surgery.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Acute rehabilitation hospital” means an institution devoted to therapy that is designed to facilitate the process of recovery from illness or injury for patients with various neurological, muscular-skeletal, orthopedic, and other medical conditions following stabilization of acute medical issues.</text> </paragraph> <paragraph num="(4)"> <text>“Administrative day” means a day of medical services delivered to a participant who no longer requires an acute level of care.</text> </paragraph> <paragraph num="(5)"> <text>“Administrative services organization (ASO)” means an organization with which the Department contracts to assist in the management and operation of the Maryland Public Behavioral Health System.</text> </paragraph> <paragraph num="(6)"> <text>“Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight.</text> </paragraph> <paragraph num="(7)"> <text>“Ancillary services” means diagnostic and therapeutic services, including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board.</text> </paragraph> <paragraph num="(8)"> <text>“Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided in an acute hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization.</text> </paragraph> <paragraph num="(9)"> <text>“Date of service” means:</text> <paragraph num="(a)"> <text>For inpatient hospitalizations, the date of admission into an acute hospital up to, but not including, the date of discharge;</text> </paragraph> <paragraph num="(b)"> <text>For outpatient services, the date services are rendered in the outpatient department of the hospital;</text> </paragraph> <paragraph num="(c)"> <text>For emergency services, the date or dates the services are rendered in the emergency department of an acute hospital; or</text> </paragraph> <paragraph num="(d)"> <text>For observation services, the date or dates the services are rendered in an acute hospital.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(11)"> <text>“Designee” means any entity designated to act on behalf of the Department.</text> </paragraph> <paragraph num="(12)"> <text>“Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses (if any), procedures performed, age, sex, and discharge status of the participant.</text> </paragraph> <paragraph num="(13)"> <text>“Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction.</text> </paragraph> <paragraph num="(14)"> <text>“Emergency department” means the area in a hospital that is designed, staffed, and equipped to provide prompt treatment to individuals requiring immediate medical care for acute illness, trauma, and other medical conditions.</text> </paragraph> <paragraph num="(15)"> <text>“Emergency services” means any health care service provided to evaluate and treat any medical condition where immediate, unscheduled medical care is required.</text> </paragraph> <paragraph num="(16)"> <text>“Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment of bodily functions; or</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Freestanding medical facility” means a facility:</text> <paragraph num="(a)"> <text>In which medical and health services are provided;</text> </paragraph> <paragraph num="(b)"> <text>That is physically separate from a hospital or hospital grounds; and</text> </paragraph> <paragraph num="(c)"> <text>That is an administrative part of a hospital or related institution.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals.</text> </paragraph> <paragraph num="(20)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(22)"> <text>“Nonqualified alien” means a foreign-born resident who:</text> <paragraph num="(a)"> <text>Is not a naturalized U.S. citizen; and</text> </paragraph> <paragraph num="(b)"> <text>Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Observation services” means the medically necessary services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient acute care setting.</text> </paragraph> <paragraph num="(24)"> <text>“Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver.</text> </paragraph> <paragraph num="(25)"> <text>“Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia.</text> </paragraph> <paragraph num="(26)"> <text>“Outpatient services” means nonemergency services provided to the participant on the hospital campus that do not require hospital admission.</text> </paragraph> <paragraph num="(27)"> <text>“Participant” means an individual who is enrolled with the Department to receive Medical Assistance services.</text> </paragraph> <paragraph num="(28)"> <text>“Patient” means an individual awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(29)"> <text>“Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed.</text> </paragraph> <paragraph num="(30)"> <text>“Preoperative day” means an inpatient day in an acute hospital before:</text> <paragraph num="(a)"> <text>Surgery for a participant who is being admitted for surgery; or</text> </paragraph> <paragraph num="(b)"> <text>A surgical procedure when the participant was admitted for a nonsurgical procedure but the need for surgery arose during that stay.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(32)"> <text>“Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services.</text> </paragraph> <paragraph num="(33)"> <text>“Provider” means an acute hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(34)"> <text>“Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital.</text> </paragraph> <paragraph num="(35)"> <text>“Specialty behavioral health” means services as defined in COMAR 10.09.70.02D and F.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>In order to participate in the Program, a provider shall:</text> <paragraph num="(1)"> <text>Be licensed as a hospital by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain other licenses, as set forth in COMAR 10.07.01.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with:</text> <paragraph num="(a)"> <text>All applicable standards established by the state or locality in which the service is provided; and</text> </paragraph> <paragraph num="(b)"> <text>The requirements of COMAR 10.09.09.02.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program as an acute hospital services provider, the provider shall:</text> <paragraph num="(1)"> <text>Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services;</text> </paragraph> <paragraph num="(2)"> <text>Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services;</text> </paragraph> <paragraph num="(3)"> <text>Accept payment by the Program as payment in full for the covered service;</text> </paragraph> <paragraph num="(4)"> <text>Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay;</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>The participant’s chief medical complaint or reason for visit;</text> </paragraph> <paragraph num="(c)"> <text>A description of the services provided, including:</text> <paragraph num="(i)"> <text>Progress notes;</text> </paragraph> <paragraph num="(ii)"> <text>Imaging studies;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory results;</text> </paragraph> <paragraph num="(iv)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(v)"> <text>Discharge summary; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the hospital provider is the only hospital within the county, participate with each participating HealthChoice Managed Care Organization in the county.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an out-of-State or District of Columbia hospital, the hospital shall:</text> <paragraph num="(1)"> <text>Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with applicable regulations of this chapter and COMAR 10.09.36.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the services listed in §B of this regulation according to the conditions and requirements indicated.</text> </paragraph> <paragraph num="B."> <text>The Program covers the following hospital services:</text> <paragraph num="(1)"> <text>Medically necessary emergency services as defined in COMAR 10.09.36.01, including triage, related ancillary services, and when necessary, observation stays of a participant who presents to a hospital emergency department;</text> </paragraph> <paragraph num="(2)"> <text>Medically necessary services performed in an outpatient department of a hospital;</text> </paragraph> <paragraph num="(3)"> <text>Medically necessary services performed at a freestanding medical facility;</text> </paragraph> <paragraph num="(4)"> <text>Medically necessary inpatient hospital services meeting the following criteria:</text> <paragraph num="(a)"> <text>Inpatient days, including preoperative days, determined to be medically necessary by the Department or its designee;</text> </paragraph> <paragraph num="(b)"> <text>Admissions from an emergency department resulting in a medically necessary inpatient stay; and</text> </paragraph> <paragraph num="(c)"> <text>Elective admissions that the Department or its designee determines to be medically necessary;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Inpatient stays determined to be medically necessary due to an emergent condition by the Department or its designee for a nonqualified alien;</text> </paragraph> <paragraph num="(6)"> <text>Administrative days, which may include select ancillary services, determined to be necessary by the Department or its designee; and</text> </paragraph> <paragraph num="(7)"> <text>Medically necessary services performed in an acute rehabilitation hospital when the participant meets the following criteria at the time of admission:</text> <paragraph num="(a)"> <text>Requires active and ongoing therapeutic intervention of multiple therapy disciplines, one of which shall be physical or occupational therapy;</text> </paragraph> <paragraph num="(b)"> <text>Requires and can reasonably be expected to actively participate in, and benefit from, the therapy, which generally consists of:</text> <paragraph num="(i)"> <text>At least 3 hours of therapy a day, at least 5 days a week; or</text> </paragraph> <paragraph num="(ii)"> <text>In well-documented cases, at least 15 hours of intensive rehabilitation therapy within a 7 day consecutive period;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is sufficiently stable to be able to actively participate in the therapy program; and</text> </paragraph> <paragraph num="(d)"> <text>Requires supervision by a licensed physician, who has specialized training and experience in inpatient rehabilitation, which includes:</text> <paragraph num="(i)"> <text>Conducting face-to-face visits with the patient at least 3 days a week to assess the patient both medically and functionally; and</text> </paragraph> <paragraph num="(ii)"> <text>Modifying the course of treatment as needed to maximize the participant's capacity to benefit from the rehabilitation process.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The coverage of ancillary services during administrative days as described under §B(6) of this regulation applies to special pediatric hospitals under COMAR 10.09.94.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover:</text> <paragraph num="A."> <text>Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental;</text> </paragraph> <paragraph num="B."> <text>Hospital services denied by Medicare as not medically necessary;</text> </paragraph> <paragraph num="C."> <text>Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant's inability to take appropriate oral medications is documented in the participant's medical record;</text> </paragraph> <paragraph num="D."> <text>Elective inpatient admissions without preauthorization;</text> </paragraph> <paragraph num="E."> <text>Elective inpatient admissions from the emergency department for dialysis services that are the result of problems occurring with placement in a freestanding dialysis facility;</text> </paragraph> <paragraph num="F."> <text>Outpatient visits for one or more of the following:</text> <paragraph num="(1)"> <text>Prescription drug or food supplement pick up;</text> </paragraph> <paragraph num="(2)"> <text>Collection of specimens for laboratory procedures;</text> </paragraph> <paragraph num="(3)"> <text>Recording of an electrocardiogram;</text> </paragraph> <paragraph num="(4)"> <text>Ascertaining the participant's weight; and</text> </paragraph> <paragraph num="(5)"> <text>Administration of vaccines;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Interpretation of laboratory tests or panels;</text> </paragraph> <paragraph num="H."> <text>Autopsies;</text> </paragraph> <paragraph num="I."> <text>Weight control medications;</text> </paragraph> <paragraph num="J."> <text>Care provided to a well newborn beyond the:</text> <paragraph num="(1)"> <text>Length of the mother's stay for a normal obstetrical or uncomplicated caesarean section delivery; or</text> </paragraph> <paragraph num="(2)"> <text>First 4 days of the newborn's life when the mother remains in the hospital due to other circumstances;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Telephones, televisions, or personal comfort items or services;</text> </paragraph> <paragraph num="L."> <text>Duplicate care or services;</text> </paragraph> <paragraph num="M."> <text>Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland;</text> </paragraph> <paragraph num="N."> <text>Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner;</text> </paragraph> <paragraph num="O."> <text>Inpatient days provided in excess of the days approved by the Department or its designee;</text> </paragraph> <paragraph num="P."> <text>Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital for a participant receiving inpatient, outpatient, emergency department, or observation services;</text> </paragraph> <paragraph num="Q."> <text>Hospital services provided outside of the United States; and</text> </paragraph> <paragraph num="R."> <text>Ancillary services that are part of an observation stay beyond the initial 24 hours.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Utilization Review."> <paragraph num="A."> <text>Elective Inpatient Preauthorization Reviews.</text> <paragraph num="(1)"> <text>The hospital shall only request preauthorization for inpatient stays when such services:</text> <paragraph num="(a)"> <text>Cannot be provided on an outpatient basis; or</text> </paragraph> <paragraph num="(b)"> <text>Can only be provided in a facility that is licensed as an acute hospital.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to:</text> <paragraph num="(a)"> <text>Participant’s medical history and physical; and</text> </paragraph> <paragraph num="(b)"> <text>Sufficient clinical information or documentation that supports the medical necessity of the acute inpatient admission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Reviews.</text> <paragraph num="(1)"> <text>As long as the participant remains hospitalized, the Department or its designee shall perform concurrent reviews based on the participant’s diagnosis and medical condition.</text> </paragraph> <paragraph num="(2)"> <text>For emergency inpatient admissions that exceed more than 24 hours, the concurrent review process shall be initiated by the hospital within the first 48 hours of the admission, or by the next business day.</text> </paragraph> <paragraph num="(3)"> <text>For elective inpatient admissions, the hospital shall initiate the concurrent review process before the termination of days previously certified by the Department or its designee.</text> </paragraph> <paragraph num="(4)"> <text>The hospital shall forward sufficient clinical documentation to the Department or its designee that supports the need for continuing acute care. Documentation submitted shall include, but is not limited to:</text> <paragraph num="(a)"> <text>Current medical health status;</text> </paragraph> <paragraph num="(b)"> <text>Treatment received to date; and</text> </paragraph> <paragraph num="(c)"> <text>A proposed treatment plan for the continued stay.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Retrospective Reviews.</text> <paragraph num="(1)"> <text>The hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission and stay.</text> </paragraph> <paragraph num="(2)"> <text>The hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from an acute hospital. Documentation submitted shall include, but is not limited to:</text> <paragraph num="(a)"> <text>The participant’s complete medical record;</text> </paragraph> <paragraph num="(b)"> <text>The principal, secondary, and tertiary diagnoses; and</text> </paragraph> <paragraph num="(c)"> <text>All surgical procedure codes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A.</text> </paragraph> <paragraph num="E."> <text>Reviews for Behavioral Health. The hospital shall contact the behavioral health ASO to request an authorization for all inpatient admissions that are described in COMAR 10.09.70.02D and F.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement Principles for Acute Hospitals Located in Maryland.</text> <paragraph num="(1)"> <text>The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals.</text> </paragraph> <paragraph num="(2)"> <text>Except for administrative days, acute hospitals shall be reimbursed at the rate set for the Program by the HSCRC pursuant to COMAR 10.37.10 or allowed under COMAR 10.37.03.</text> </paragraph> <paragraph num="(3)"> <text>If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers:</text> <paragraph num="(a)"> <text>According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or</text> </paragraph> <paragraph num="(b)"> <text>On the basis of charges if less than reasonable cost.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department may not reimburse for the services of a hospital’s salaried or contractual clinical staff as a separate line item. Charges for these services should be included in the room and board rate or the appropriate ancillary service only, when HSCRC has included these salaries in the hospital’s costs.</text> </paragraph> <paragraph num="(5)"> <text>The Program shall reimburse room and board charges from the day of admission up to, but not including, the date of discharge from the hospital.</text> </paragraph> <paragraph num="(6)"> <text>The provider shall submit a request for payment according to procedures established by the Department.</text> </paragraph> <paragraph num="(7)"> <text>The Program reserves the right to return to the provider any invoice that is not properly completed.</text> </paragraph> <paragraph num="(8)"> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(a)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(b)"> <text>Medicare makes a direct payment to the provider;</text> </paragraph> <paragraph num="(c)"> <text>Medicare determined that services are medically necessary;</text> </paragraph> <paragraph num="(d)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(e)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>The Department shall make a supplemental payment on Medicare claims as follows:</text> <paragraph num="(a)"> <text>Deductible and co-insurance shall be paid in accordance with the limits of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Hospitals shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case the deductible and co-insurance shall be paid in full.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The provider shall not bill the Department or participant for:</text> <paragraph num="(a)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(b)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(c)"> <text>Services rendered by mail, telephone, or otherwise not in person, with the exception of telehealth services in accordance with COMAR 10.09.49; and</text> </paragraph> <paragraph num="(d)"> <text>Providing a copy of a participant’s medical record, when requested by another licensed provider on behalf of the participant.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Billing time limitations are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="(12)"> <text>Freestanding medical facilities are reimbursed by the Department at the rate set for the freestanding facility by HSCRC.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursement Principles for Out-of-State Hospitals.</text> <paragraph num="(1)"> <text>For hospitals outside of Maryland, excluding the District of Columbia, claims reflecting dates of service on or after October 1, 2009, shall be reimbursed at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less.</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State providers are responsible for reimbursing the Department or its designee for overpayments, in accordance with COMAR 10.09.36.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursement Principles for Administrative Days.</text> <paragraph num="(1)"> <text>The hospital shall be paid for administrative days that are requested at the time of retrospective review and that are authorized by the Department or its designee after review of the:</text> <paragraph num="(a)"> <text>Clinical documentation;</text> </paragraph> <paragraph num="(b)"> <text>Discharge plan indicating that the hospital was seeking placement for the participant on the administrative days requested; and</text> </paragraph> <paragraph num="(c)"> <text>Documentation that was submitted to the Department on the authorized form that shows placement activity occurred on each day claimed as an administrative day.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To be paid for administrative days, for participants who are not ventilator dependent, the reimbursement amount shall be an estimated Statewide average of the Program nursing home payment rate as determined by the Department.</text> </paragraph> <paragraph num="(3)"> <text>A hospital is not eligible for administrative day reimbursement if the days have already been billed as acute days.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reimbursement Principles for Freestanding Acute Rehabilitation Hospitals. For freestanding acute rehabilitation hospitals not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="District of Columbia Hospital Reimbursement."> <paragraph num="A."> <text>Inpatient Services Rate Calculation.</text> <paragraph num="(1)"> <text>A hospital in the District of Columbia shall:</text> <paragraph num="(a)"> <text>Bill its usual and customary charges; and</text> </paragraph> <paragraph num="(b)"> <text>Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The percentage of charges in §A(1) of this regulation is the product of the following:</text> <paragraph num="(a)"> <text>The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee;</text> </paragraph> <paragraph num="(b)"> <text>The lesser of 100 percent or the cost-to-charge projection percentage which is:</text> <paragraph num="(i)"> <text>The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and</text> </paragraph> <paragraph num="(ii)"> <text>Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The percentage of the hospital’s costs which are efficiently and economically incurred as adjusted to reflect labor market differences between District of Columbia hospitals and Maryland hospitals; and</text> </paragraph> <paragraph num="(d)"> <text>The uncompensated care factor which is equal to:</text> <paragraph num="(i)"> <text>For pediatric hospitals with average lengths of stay less than 18 days, one plus two and a half times the quotient of the hospital’s uncompensated care divided by gross revenue; or</text> </paragraph> <paragraph num="(ii)"> <text>For all other hospitals, one plus the quotient of the hospital’s uncompensated care divided by gross revenue.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent.</text> </paragraph> <paragraph num="(4)"> <text>A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .07C of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>Efficiently and economically incurred District of Columbia hospitals’ costs are those costs which are:</text> <paragraph num="(a)"> <text>Less than or equal to the adjusted costs for the same all-participant, refined-diagnosis-related groups in Maryland hospitals;</text> </paragraph> <paragraph num="(b)"> <text>For hospitals with average lengths of stay of 18 days or more:</text> <paragraph num="(i)"> <text>Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and</text> </paragraph> <paragraph num="(ii)"> <text>Categorized into the following two age groups: younger than 18 years old, and 18 years old or older;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Exclusive of:</text> <paragraph num="(i)"> <text>Maryland case charges greater than $500,000; and</text> </paragraph> <paragraph num="(ii)"> <text>District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Derived from hospital costs as specified in this subsection.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Maryland hospital costs are the hospitals’ charges reduced by the hospital-specific ratio of operating costs to gross charges as determined by the Program or designee.</text> </paragraph> <paragraph num="(7)"> <text>There may not be a year-end cost settlement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Outpatient Services.</text> <paragraph num="(1)"> <text>A hospital located in the District of Columbia shall:</text> <paragraph num="(a)"> <text>Bill its usual and customary charges; and</text> </paragraph> <paragraph num="(b)"> <text>Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The percentage of charges in §B(1) of this regulation is the product of:</text> <paragraph num="(a)"> <text>The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and</text> </paragraph> <paragraph num="(b)"> <text>The lesser of 100 percent or the cost-to-charge projection percentage which is:</text> <paragraph num="(i)"> <text>The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and</text> </paragraph> <paragraph num="(ii)"> <text>Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent.</text> </paragraph> <paragraph num="(4)"> <text>The analysis shall be performed by the Program or its designee.</text> </paragraph> <paragraph num="(5)"> <text>There may not be a year-end cost settlement.</text> </paragraph> <paragraph num="(6)"> <text>Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Submitting Cost Reports.</text> <paragraph num="(1)"> <text>The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="(2)"> <text>When reports are not received within 5 months and an extension has not been granted:</text> <paragraph num="(a)"> <text>For hospitals reimbursed in accordance with this regulation, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or</text> </paragraph> <paragraph num="(b)"> <text>For hospitals reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall:</text> <paragraph num="(i)"> <text>Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and</text> </paragraph> <paragraph num="(ii)"> <text>Refund withholdings at cost settlement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="(4)"> <text>The Program shall grant an extension for submission of cost reports:</text> <paragraph num="(a)"> <text>Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or</text> </paragraph> <paragraph num="(b)"> <text>Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled.</text> </paragraph> <paragraph num="(7)"> <text>For purposes of §C(1)—(6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> <paragraph num="(8)"> <text>When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using the latest cost report information shall be implemented starting with the 1st day of the 4th full calendar month after the month in which the report was received by the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Submitting Cost Reports for Freestanding Acute Rehabilitation Hospitals."> <paragraph num="A."> <text>The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="B."> <text>For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall:</text> <paragraph num="(1)"> <text>Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and</text> </paragraph> <paragraph num="(2)"> <text>Refund withholdings at cost settlement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="D."> <text>The Program shall grant an extension for submission of cost reports:</text> <paragraph num="(1)"> <text>Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or</text> </paragraph> <paragraph num="(2)"> <text>Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="F."> <text>When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled.</text> </paragraph> <paragraph num="G."> <text>For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Cost Settlement for Freestanding Acute Rehabilitation Hospitals."> <paragraph num="A."> <text>Retrospective Cost Reimbursement for Freestanding Acute Rehabilitation Hospitals.</text> <paragraph num="(1)"> <text>An acute rehabilitation hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost.</text> </paragraph> <paragraph num="(2)"> <text>In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants.</text> </paragraph> <paragraph num="(3)"> <text>When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs.</text> </paragraph> <paragraph num="(4)"> <text>Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found in 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year.</text> </paragraph> <paragraph num="(5)"> <text>Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be:</text> <paragraph num="(a)"> <text>For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; or</text> </paragraph> <paragraph num="(b)"> <text>For a new provider, the 12-month period immediately before the provider was initially subject to target rate increases.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, the following:</text> <paragraph num="(a)"> <text>A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate;</text> </paragraph> <paragraph num="(b)"> <text>A current, projected, and prior year’s charge rate schedule;</text> </paragraph> <paragraph num="(c)"> <text>Finalized prior year’s Medicare cost reports and the most current submission;</text> </paragraph> <paragraph num="(d)"> <text>A detailed revenue schedule; and</text> </paragraph> <paragraph num="(e)"> <text>Audited financial statements.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services.</text> </paragraph> <paragraph num="(8)"> <text>Initial Interim Rates for Newly Established Services or Providers.</text> <paragraph num="(a)"> <text>The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding that supports the requested rate that follows.</text> </paragraph> <paragraph num="(b)"> <text>The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Revision of Interim Rates.</text> <paragraph num="(a)"> <text>The provider may request an interim rate revision if the actual and projected costs exceed the interim rate by 10 percent.</text> </paragraph> <paragraph num="(b)"> <text>The provider shall furnish the Department or its designee with appropriate documentation showing the reason for the increase and other necessary comparisons.</text> </paragraph> <paragraph num="(c)"> <text>The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review.</text> </paragraph> <paragraph num="(d)"> <text>The provider may request no more than one interim rate revision during the provider’s fiscal year.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Cost Settlement. The provider shall submit to the Department or its designee:</text> <paragraph num="(a)"> <text>A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement;</text> </paragraph> <paragraph num="(b)"> <text>A copy of its Maryland Medical Assistance log;</text> </paragraph> <paragraph num="(c)"> <text>Cost reports that are sufficient in detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers; and</text> </paragraph> <paragraph num="(d)"> <text>A finalized Medicare cost report for the cost reporting year.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Final Program costs shall be Maryland Medical Assistance specific.</text> </paragraph> <paragraph num="(12)"> <text>Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department.</text> </paragraph> <paragraph num="(13)"> <text>The Department will base final settlement on the results of the finalized Medicare cost reports.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under §A(10)—(13) of this regulation.</text> </paragraph> <paragraph num="C."> <text>Within 60 days after the provider receives the notification described in §B of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal.</text> </paragraph> <paragraph num="D."> <text>The provider may request review of the settlement under §A(10)—(13) of this regulation by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee.</text> </paragraph> <paragraph num="E."> <text>The Appeal Board shall be composed of the following:</text> <paragraph num="(1)"> <text>A representative of the hospital industry who is:</text> <paragraph num="(a)"> <text>Knowledgeable in Medicare and Medicaid reimbursement principles; and</text> </paragraph> <paragraph num="(b)"> <text>Appointed by the Secretary of the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual who:</text> <paragraph num="(a)"> <text>Is employed by the State;</text> </paragraph> <paragraph num="(b)"> <text>Is knowledgeable in Medicare and Medicaid reimbursement principles;</text> </paragraph> <paragraph num="(c)"> <text>Did not participate in the verification of costs; and</text> </paragraph> <paragraph num="(d)"> <text>Is appointed by the Secretary of the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A third member selected by the first two members of the Appeal Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member.</text> </paragraph> <paragraph num="G."> <text>If the provider elects not to appeal to the Appeal Board:</text> <paragraph num="(1)"> <text>The provider shall pay the amount due within 60 days after the notification described in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The provider may request a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and</text> </paragraph> <paragraph num="(3)"> <text>The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would:</text> <paragraph num="(a)"> <text>Result in financial hardship to the provider; or</text> </paragraph> <paragraph num="(b)"> <text>Have an adverse effect on the quality of participant care furnished by the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>If the provider elects to appeal to the Appeal Board, the following provisions apply:</text> <paragraph num="(1)"> <text>Within 30 days after a provider’s filing of an appeal of the Department or its designee’s determination that the provider owes money to the Program, the Department or its designee shall:</text> <paragraph num="(a)"> <text>Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed;</text> </paragraph> <paragraph num="(3)"> <text>Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and</text> </paragraph> <paragraph num="(4)"> <text>If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Appeal Board Findings.</text> <paragraph num="(1)"> <text>After the Department receives the findings of the Appeal Board, the Department shall:</text> <paragraph num="(a)"> <text>Determine the amount that is due either to the Program or to the provider; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The portion of the amount in controversy that is paid is subject to an award of interest that is:</text> <paragraph num="(a)"> <text>Calculated from the date the appeal was filed through the date of payment; and</text> </paragraph> <paragraph num="(b)"> <text>Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs.</text> </paragraph> <paragraph num="(4)"> <text>If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any.</text> </paragraph> <paragraph num="(5)"> <text>Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any.</text> </paragraph> <paragraph num="(6)"> <text>If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§G—I of this regulation, and in addition to the sanctions provided in Regulation .12 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider.</text> </paragraph> <paragraph num="K."> <text>The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland.</text> </paragraph> <paragraph num="L."> <text>If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination.</text> </paragraph> <paragraph num="M."> <text>The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07.</text> </paragraph> <paragraph num="B."> <text>If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Appeal Procedures."> <text>A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2017 (44:7 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05P, Q amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 R adopted effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> </annotations> </chapter> <chapter num="93" heading="Chronic Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver.</text> </paragraph> <paragraph num="(3)"> <text>“Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where individuals stay at least overnight.</text> </paragraph> <paragraph num="(4)"> <text>“Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board.</text> </paragraph> <paragraph num="(5)"> <text>“Appropriate facility” means:</text> <paragraph num="(a)"> <text>A facility located within a 25-mile radius of the participant’s residence; or</text> </paragraph> <paragraph num="(b)"> <text>If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Brain injury” means an injury or insult to the brain that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record.</text> </paragraph> <paragraph num="(7)"> <text>“Brain injury community integration program” means a program located on the campus of a licensed chronic hospital and approved by the Department to treat individuals with primary diagnoses of brain injury resulting in functional limitations and disability, who need services designed to transition to home or a community-based program of services and supports.</text> </paragraph> <paragraph num="(8)"> <text>Chronic Hospital.</text> <paragraph num="(a)"> <text>“Chronic hospital” means an institution licensed by the Maryland Department of Health in accordance with COMAR 10.07.01.03B, which provides services to patients with complex medical needs who do not require hospitalization in an acute hospital, but whose treatment needs exceed the capabilities of a nursing facility.</text> </paragraph> <paragraph num="(b)"> <text>“Chronic hospital” does not mean a:</text> <paragraph num="(i)"> <text>Long-term care hospital, as defined at 42 CFR §412.23(e); or</text> </paragraph> <paragraph num="(ii)"> <text>Long-term care facility, as defined at 42 CFR §483.5(a).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a chronic hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization.</text> </paragraph> <paragraph num="(10)"> <text>“Date of service” means:</text> <paragraph num="(a)"> <text>For inpatient hospitalizations, the date of admission into a chronic hospital up to, but not including, the date of discharge; or</text> </paragraph> <paragraph num="(b)"> <text>For outpatient services, the date services are rendered in the outpatient department of the hospital.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Designee” means any entity designated to act on behalf of the Department.</text> </paragraph> <paragraph num="(13)"> <text>“Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction.</text> </paragraph> <paragraph num="(14)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Interdisciplinary team” means a physician-led multidisciplinary clinical team consisting of, at a minimum:</text> <paragraph num="(a)"> <text>The participant or an individual of the participant’s choice;</text> </paragraph> <paragraph num="(b)"> <text>A physician;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(d)"> <text>A social worker;</text> </paragraph> <paragraph num="(e)"> <text>The participant’s case manager; and</text> </paragraph> <paragraph num="(f)"> <text>Any other clinical professional indicated by an individual’s specific needs, including but not limited to:</text> <paragraph num="(i)"> <text>A psychologist;</text> </paragraph> <paragraph num="(ii)"> <text>A behavioral analyst;</text> </paragraph> <paragraph num="(iii)"> <text>A dietitian or nutritionist; and</text> </paragraph> <paragraph num="(iv)"> <text>Licensed therapists in other disciplines.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(17)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(19)"> <text>“Neuro-behavioral” means the discipline within medical rehabilitation that focuses on behavioral impairments seen in association with brain injury resulting from trauma, hypoxia, or ischemia.</text> </paragraph> <paragraph num="(20)"> <text>“Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia.</text> </paragraph> <paragraph num="(21)"> <text>“Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission.</text> </paragraph> <paragraph num="(22)"> <text>“Participant” means an individual who is enrolled with the Department to receive Medical Assistance services.</text> </paragraph> <paragraph num="(23)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(24)"> <text>“Provider” means a chronic hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>In order to participate in the Program, a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain any other licenses required by COMAR 10.07.01.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall obtain accreditation by the Commission on Accreditation of Rehabilitation Facilities if it provides neuro-behavioral rehabilitation or brain injury services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation — General."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program as a chronic hospital services provider, the provider shall:</text> <paragraph num="(1)"> <text>Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services;</text> </paragraph> <paragraph num="(2)"> <text>24 hours per day, 7 days per week, meet the following staffing requirements:</text> <paragraph num="(a)"> <text>On-call or on-site physician services;</text> </paragraph> <paragraph num="(b)"> <text>On-site registered nurses;</text> </paragraph> <paragraph num="(c)"> <text>On-site respiratory therapist services; and</text> </paragraph> <paragraph num="(d)"> <text>On-site advanced cardiac life support services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services;</text> </paragraph> <paragraph num="(4)"> <text>Accept payment by the Program as payment in full for the covered service;</text> </paragraph> <paragraph num="(5)"> <text>Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and</text> </paragraph> <paragraph num="(6)"> <text>Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>The participant’s chief medical complaint or reason for admission;</text> </paragraph> <paragraph num="(c)"> <text>A description of the services provided, including:</text> <paragraph num="(i)"> <text>Progress notes;</text> </paragraph> <paragraph num="(ii)"> <text>Imaging studies;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory results;</text> </paragraph> <paragraph num="(iv)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(v)"> <text>Discharge summary; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Specific Conditions for Provider Participation — Brain Injury Community Integration Program."> <paragraph num="A."> <text>To participate in the Program as a provider operating a brain injury community integration program, the provider shall be:</text> <paragraph num="(1)"> <text>Accredited by the Commission on Accreditation of Rehabilitation Facilities; and</text> </paragraph> <paragraph num="(2)"> <text>Approved by the Department to provide the Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Requirements. In addition to the requirements in Regulation .03 of this chapter, a brain injury community integration program shall meet staffing requirements, as approved by the Program, necessary to provide the neuro-behavioral management programming set forth in Regulation .05D of this chapter.</text> </paragraph> <paragraph num="C."> <text>At least annually, in a form specified by the Program, a provider operating a brain injury community integration program shall report on the individuals admitted to and participating in the program, including:</text> <paragraph num="(1)"> <text>Length of stay;</text> </paragraph> <paragraph num="(2)"> <text>Discharge setting; and</text> </paragraph> <paragraph num="(3)"> <text>Any other data specified by the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>Chronic hospitals shall provide the following services:</text> <paragraph num="(1)"> <text>Complex respiratory care services;</text> </paragraph> <paragraph num="(2)"> <text>Complex wound care services;</text> </paragraph> <paragraph num="(3)"> <text>Services for participants with multiple co-morbidities, including but not limited to services necessary to care for:</text> <paragraph num="(a)"> <text>Ventilator-assisted individuals who have been ventilator dependent for less than 6 months and who need further medical stabilization or are candidates for weaning from ventilator assistance;</text> </paragraph> <paragraph num="(b)"> <text>Tracheostomy participants who require suctioning more frequently than every 2 hours or are candidates for decannulation;</text> </paragraph> <paragraph num="(c)"> <text>More than two extensive stage IV decubiti which require daily intensive treatment that is not available in a nursing facility; or</text> </paragraph> <paragraph num="(d)"> <text>Extensive post-operative or post-traumatic care with multiple drains or extensive dressing change or therapies beyond the capabilities of a nursing facility;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For participants admitted for medically necessary rehabilitation services, physical therapy, occupational therapy, or speech therapy, directed by an interdisciplinary team; and</text> </paragraph> <paragraph num="(5)"> <text>Ancillary services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Treatment Plan.</text> <paragraph num="(1)"> <text>Within 24 hours of a participant’s admission, a physician shall perform a documented face-to-face evaluation of the participant and begin developing an individualized treatment plan designed to meet the participant’s assessed needs.</text> </paragraph> <paragraph num="(2)"> <text>By the 7th day of a participant’s admission, an interdisciplinary team shall establish a written, individualized treatment plan for the participant, which shall include, at a minimum:</text> <paragraph num="(a)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(b)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(c)"> <text>Frequency of interventions for each type of service ordered;</text> </paragraph> <paragraph num="(d)"> <text>Duration of treatment of each type of service ordered; and</text> </paragraph> <paragraph num="(e)"> <text>Prognosis.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The physician-led interdisciplinary team shall update the individualized treatment plan weekly until discharge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program covers outpatient hospital services provided by a chronic hospital when the services are:</text> <paragraph num="(1)"> <text>Medically necessary; and</text> </paragraph> <paragraph num="(2)"> <text>Provided to individuals who are eligible for Medical Assistance and who are not current inpatients at the chronic hospital, except when payment for certain outpatient services provided to a participant on the date of inpatient admission or within 3 calendar days before the date of an inpatient admission are bundled, in accordance with 42 CFR §412.2(c)(5).</text> </paragraph> </paragraph> <paragraph num="D."> <text>The program covers the following brain injury community integration program services:</text> <paragraph num="(1)"> <text>Neuro-behavioral management programming, which includes, but is not limited to:</text> <paragraph num="(a)"> <text>Assessment of maladaptive behaviors using valid and reliable behavioral measurement tools;</text> </paragraph> <paragraph num="(b)"> <text>Pharmacologic intervention provided to manage maladaptive behaviors related to brain injury;</text> </paragraph> <paragraph num="(c)"> <text>Neuro-behavioral programming created, implemented, overseen, and revised as needed;</text> </paragraph> <paragraph num="(d)"> <text>Incorporation of neuro-behavioral programming into therapy and care for participants in the community integration program; and</text> </paragraph> <paragraph num="(e)"> <text>Referral to a neuro-psychiatrist, as needed, if a neuro-psychiatrist is not a member of the facility staff;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cognitive skills adaptation and compensation programming, including:</text> <paragraph num="(a)"> <text>Specific programming dedicated to cognitive skills adaptation and compensation; and</text> </paragraph> <paragraph num="(b)"> <text>Incorporation of cognitive compensatory strategies into community integration program participant’s interdisciplinary team treatment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Community re-entry programming, including specific programming dedicated to social or pragmatic skills, leisure skills, and life skills; and</text> </paragraph> <paragraph num="(4)"> <text>According to the participant’s needs:</text> <paragraph num="(a)"> <text>The services of a psychiatrist or psychiatric nurse;</text> </paragraph> <paragraph num="(b)"> <text>Services and supports related to substance use disorders and other addictions;</text> </paragraph> <paragraph num="(c)"> <text>Speech therapy, which includes but is not limited to:</text> <paragraph num="(i)"> <text>Cognitive skills;</text> </paragraph> <paragraph num="(ii)"> <text>Communication skills;</text> </paragraph> <paragraph num="(iii)"> <text>Swallowing ability; and</text> </paragraph> <paragraph num="(iv)"> <text>Linguistic programming that assists the patient to connect the meaning of words to their context;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Occupational therapy, which includes but is not limited to:</text> <paragraph num="(i)"> <text>Instrumental activities of daily living; and</text> </paragraph> <paragraph num="(ii)"> <text>Community re-entry activities;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Physical therapy, which includes but is not limited to:</text> <paragraph num="(i)"> <text>Ambulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Motor planning and coordination;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Dietary services, which includes but is not limited to nutritional needs assessment and monitoring; and</text> </paragraph> <paragraph num="(g)"> <text>Case management, which includes but is not limited to:</text> <paragraph num="(i)"> <text>Treatment planning; and</text> </paragraph> <paragraph num="(ii)"> <text>Discharge planning.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Program covers administrative days approved by the Department or its designee according to the conditions set forth in Regulation .08C of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <text>The Program does not cover:</text> <paragraph num="A."> <text>Services for individuals who are not eligible for Medicaid;</text> </paragraph> <paragraph num="B."> <text>Services for individuals who are not medically eligible for chronic hospital services;</text> </paragraph> <paragraph num="C."> <text>Services identified by the Department or its designee as not medically necessary;</text> </paragraph> <paragraph num="D."> <text>Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental;</text> </paragraph> <paragraph num="E."> <text>Duplicated care or services;</text> </paragraph> <paragraph num="F."> <text>Interpretation of laboratory tests or panels;</text> </paragraph> <paragraph num="G."> <text>Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner involved in the participant’s care; or</text> </paragraph> <paragraph num="H."> <text>Telephones, televisions, or personal comfort items or services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Medical Eligibility."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>An admission to a chronic hospital is medically necessary for a participant whose:</text> <paragraph num="(a)"> <text>Medical condition is not stabilized subsequent to a course of treatment at an acute hospital, or whose deteriorating medical condition resulted in a readmission to an acute hospital from a nursing facility or community setting; and</text> </paragraph> <paragraph num="(b)"> <text>Service and care needs require active and continuing medical treatment at an intensity and frequency not provided in a nursing facility, as defined in COMAR 10.09.10.01B, such as:</text> <paragraph num="(i)"> <text>24-hour availability of a physician, physician assistant, or nurse practitioner, and associated nursing staff; and</text> </paragraph> <paragraph num="(ii)"> <text>Active and continuing medical treatment by a physician at least three times per week as documented in the medical record, physician orders, and physician progress notes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An admission to a chronic hospital is medically necessary for a participant who:</text> <paragraph num="(a)"> <text>Requires rehabilitation services of a lesser intensity or frequency than the acute inpatient rehabilitation services provided in a special rehabilitation hospital; and</text> </paragraph> <paragraph num="(b)"> <text>May have comorbidities or a level of medical complexity that preclude admission to a special rehabilitation hospital.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A participant who may not be able to fully participate in a chronic hospital rehabilitation program may be admitted for a brief trial period of inpatient care after review by the Department or its designee and approval by the Program. If no progress on rehabilitative goals occurs, the participant shall be discharged to a lower level of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Criteria for Brain Injury Community Integration Programs. In order to be preauthorized by the Program for services in a brain injury community integration program, a participant:</text> <paragraph num="(1)"> <text>Shall have a primary diagnosis of brain injury;</text> </paragraph> <paragraph num="(2)"> <text>Shall be at low risk of potential medical instability;</text> </paragraph> <paragraph num="(3)"> <text>May not require acute inpatient physical rehabilitation services;</text> </paragraph> <paragraph num="(4)"> <text>Shall require an intensive neuro-behavioral or neuro-cognitive rehabilitation program at a chronic level of care as described in §A of this regulation in order to:</text> <paragraph num="(a)"> <text>Address pervasive and persisting maladaptive behaviors, or behavioral health risk factors, that preclude a safe discharge to the community or to a less restrictive setting; and</text> </paragraph> <paragraph num="(b)"> <text>Relearn basic living and adaptive skills;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shall have potential for achievement of specific functional outcomes with the potential of improving functional ability so that discharge to a less restrictive setting is a reasonable goal;</text> </paragraph> <paragraph num="(6)"> <text>Shall need rehabilitative programming, which may include:</text> <paragraph num="(a)"> <text>Recreation therapy;</text> </paragraph> <paragraph num="(b)"> <text>Speech language pathology;</text> </paragraph> <paragraph num="(c)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(d)"> <text>Physical therapy; and</text> </paragraph> <paragraph num="(e)"> <text>Neuro-psychology;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Shall require at least two contacts daily within the rehabilitative programming that address the neuro-behavioral or neuro-cognitive needs of the participant;</text> </paragraph> <paragraph num="(8)"> <text>Shall require active and continued clinical treatment by a physician who is experienced in neuro-rehabilitation and in psychopharmacology for a minimum of three contacts per week;</text> </paragraph> <paragraph num="(9)"> <text>Shall require a structured and integrated environment of care that provides on-going behavioral programming designed to reduce maladaptive behaviors that are reinforced by clinical support and administrative staff;</text> </paragraph> <paragraph num="(10)"> <text>Shall make progress toward the achievement of specified functional outcomes; and</text> </paragraph> <paragraph num="(11)"> <text>Shall have the ability to participate in the required number of therapy sessions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Utilization Review."> <paragraph num="A."> <text>Admission and Prior Approval.</text> <paragraph num="(1)"> <text>For participants and individuals who have applied for Medical Assistance, the provider shall request a determination from the Department or its designee at the time of admission, or at the time of application for Medical Assistance, that the individual meets the medical eligibility criteria set forth in Regulation .07A of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>For a participant to be preauthorized for services in a brain injury community integration program, a provider that meets the requirements of Regulation .04 of this chapter shall request a determination from the Department or its designee that the participant meets the criteria set forth in Regulation .07B of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>If the provider obtains the determination set forth in §A(1) or (2) of this regulation after admission, the eligibility determination shall be effective on the date that the determination was requested.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Review.</text> <paragraph num="(1)"> <text>On a monthly basis, the provider shall notify the Department or its designee of all persons who have:</text> <paragraph num="(a)"> <text>Received an initial determination of medical eligibility for chronic hospital services;</text> </paragraph> <paragraph num="(b)"> <text>Been determined to continue to meet medical eligibility criteria for chronic hospital services;</text> </paragraph> <paragraph num="(c)"> <text>Been discharged; or</text> </paragraph> <paragraph num="(d)"> <text>Been determined to no longer be medically eligible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Concurrent review shall be conducted every 14 days as long as the participant remains hospitalized to ensure the medical necessity of the participant’s inpatient stay.</text> </paragraph> <paragraph num="(3)"> <text>The Department or its designee may conduct on-site reviews.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Administrative Days.</text> <paragraph num="(1)"> <text>To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below:</text> <paragraph num="(a)"> <text>The participant who was initially eligible has been determined to no longer require chronic hospital services, and the provider has:</text> <paragraph num="(i)"> <text>Received a determination from the Department or its designee that the participant requires the level of service provided by a nursing facility but an appropriate facility is not available;</text> </paragraph> <paragraph num="(ii)"> <text>Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and</text> </paragraph> <paragraph num="(iii)"> <text>Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The participant is no longer medically eligible to receive chronic hospital services but cannot be moved, and the following conditions are met:</text> <paragraph num="(i)"> <text>The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record;</text> </paragraph> <paragraph num="(ii)"> <text>The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and</text> </paragraph> <paragraph num="(iii)"> <text>The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days.</text> </paragraph> <paragraph num="(3)"> <text>Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement of Maryland Chronic Hospitals.</text> <paragraph num="(1)"> <text>In-State chronic hospitals shall be reimbursed according to:</text> <paragraph num="(a)"> <text>Rates approved by the HSCRC pursuant to COMAR 10.37.03; or</text> </paragraph> <paragraph num="(b)"> <text>The administrative day rate as follows:</text> <paragraph num="(i)"> <text>For a participant who is not ventilator-dependent, payment for approved administrative days shall be the estimated Statewide average Medicaid nursing facility payment rate as determined by the Department; and</text> </paragraph> <paragraph num="(ii)"> <text>For a participant who is ventilator-dependent, payment for approved administrative days shall be the estimated average Medicaid nursing facility payment rate for ventilator-dependent residents as determined by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>State-operated chronic hospitals shall be reimbursed according to Regulation .10 of this chapter. The Department shall make no direct reimbursement to any State-operated chronic hospital.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursement of Out-of-State Hospitals.</text> <paragraph num="(1)"> <text>The Department shall reimburse an out-of-State hospital that provides a level of service equivalent to that provided at a chronic hospital only if:</text> <paragraph num="(a)"> <text>The proposed admission is first reviewed by the Department or its designee and the out-of-State placement is determined medically necessary according to Regulation .07A of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The hospital possesses the same certifications and accreditations as the Program requires for a comparable level of services and specific program in a Maryland chronic hospital; and</text> </paragraph> <paragraph num="(c)"> <text>The hospital meets one of the following conditions:</text> <paragraph num="(i)"> <text>The hospital proposes to provide a service or specific treatment that the participant cannot obtain in a Maryland chronic hospital; or</text> </paragraph> <paragraph num="(ii)"> <text>The hospital is located geographically closer to the established residence of the participant than a Maryland chronic hospital.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall reimburse an out-of-State hospital at the lesser of:</text> <paragraph num="(a)"> <text>The average rate established by the HSCRC for an equivalent cost center for a Maryland chronic hospital; or</text> </paragraph> <paragraph num="(b)"> <text>The rate charged by the out-of-State hospital pursuant to 42 CFR Part 412, Subpart O.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Cost Reporting — State-Operated Chronic Hospitals."> <paragraph num="A."> <text>The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="B."> <text>For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall:</text> <paragraph num="(1)"> <text>Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and</text> </paragraph> <paragraph num="(2)"> <text>Refund withholdings at cost settlement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="D."> <text>The Program shall grant an extension for submission of cost reports:</text> <paragraph num="(1)"> <text>Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or</text> </paragraph> <paragraph num="(2)"> <text>Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .14 of this chapter.</text> </paragraph> <paragraph num="F."> <text>When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled.</text> </paragraph> <paragraph num="G."> <text>For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Cost Settlement — State-operated Chronic Hospitals."> <paragraph num="A."> <text>Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Program allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year.</text> </paragraph> <paragraph num="B."> <text>Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year for an existing provider shall be the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved.</text> </paragraph> <paragraph num="C."> <text>The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment exceed the allowable cost for these services.</text> </paragraph> <paragraph num="D."> <text>Revision of Interim Rates. The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and any other information supporting the request. The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request not more than two interim rate revisions during the accounting year.</text> </paragraph> <paragraph num="E."> <text>Cost Settlement. The provider shall submit to the Department or its designee a Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. The Department will base final settlement on the results of the finalized Medicare cost reports.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Cost Settlement for State-operated Chronic Hospitals — Payments and Appeals."> <paragraph num="A."> <text>The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .11 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal.</text> </paragraph> <paragraph num="C."> <text>The provider may request review of the settlement under Regulation .11 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee.</text> </paragraph> <paragraph num="D."> <text>The Appeal Board shall be composed of the following:</text> <paragraph num="(1)"> <text>A representative of the hospital industry who is:</text> <paragraph num="(a)"> <text>Knowledgeable in Medicare and Medicaid reimbursement principles; and</text> </paragraph> <paragraph num="(b)"> <text>Appointed by the Secretary of the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A person who:</text> <paragraph num="(a)"> <text>Is employed by the State;</text> </paragraph> <paragraph num="(b)"> <text>Is knowledgeable in Medicare and Medicaid reimbursement principles;</text> </paragraph> <paragraph num="(c)"> <text>Did not participate in the verification of costs; and</text> </paragraph> <paragraph num="(d)"> <text>Is appointed by the Secretary of the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A third member selected by the first two members of the Appeal Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member.</text> </paragraph> <paragraph num="F."> <text>If the provider elects not to appeal to the Appeal Board:</text> <paragraph num="(1)"> <text>The provider shall pay the amount due within 60 days after the notification described in §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>If the provider requests a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and</text> </paragraph> <paragraph num="(3)"> <text>The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would:</text> <paragraph num="(a)"> <text>Result in financial hardship to the provider; or</text> </paragraph> <paragraph num="(b)"> <text>Have an adverse effect on the quality of participant care furnished by the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If the provider elects to appeal to the Appeal Board, the following provisions apply:</text> <paragraph num="(1)"> <text>Within 30 days after a provider appeals a determination by the Department or its designee that the provider owes money to the Program, the Department or its designee shall:</text> <paragraph num="(a)"> <text>Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed;</text> </paragraph> <paragraph num="(3)"> <text>Subject to the provisions of §G(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and</text> </paragraph> <paragraph num="(4)"> <text>If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Appeal Board Findings.</text> <paragraph num="(1)"> <text>After the Department receives the findings of the Appeal Board, the Department shall:</text> <paragraph num="(a)"> <text>Determine the amount that is due either to the Program or to the provider; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The portion of the amount in controversy that is paid is subject to an award of interest that is:</text> <paragraph num="(a)"> <text>Calculated from the date the appeal was filed through the date of payment; and</text> </paragraph> <paragraph num="(b)"> <text>Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Interest paid to a provider under §H(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs.</text> </paragraph> <paragraph num="(4)"> <text>If the provider accepted the determination made under §H(1) of this regulation, within 60 days after the provider receives the notification under §H(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any.</text> </paragraph> <paragraph num="(5)"> <text>Subject to §H(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any.</text> </paragraph> <paragraph num="(6)"> <text>If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—H of this regulation, and in addition to the sanctions provided in Regulation .14 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider.</text> </paragraph> <paragraph num="J."> <text>The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland.</text> </paragraph> <paragraph num="K."> <text>If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §H(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination.</text> </paragraph> <paragraph num="L."> <text>The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07.</text> </paragraph> <paragraph num="B."> <text>If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Appeal Procedures."> <text>A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2017 (44:7 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> </annotations> </chapter> <chapter num="94" heading="Special Pediatric Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver.</text> </paragraph> <paragraph num="(3)"> <text>“Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight.</text> </paragraph> <paragraph num="(4)"> <text>“Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board.</text> </paragraph> <paragraph num="(5)"> <text>“Appropriate facility” means:</text> <paragraph num="(a)"> <text>A facility located within a 25-mile radius of the participant’s residence; or</text> </paragraph> <paragraph num="(b)"> <text>If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a special pediatric hospital, which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization.</text> </paragraph> <paragraph num="(7)"> <text>“Date of service” means:</text> <paragraph num="(a)"> <text>For inpatient hospitalizations, the date of admission into a special pediatric hospital up to, but not including, the date of discharge; or</text> </paragraph> <paragraph num="(b)"> <text>For outpatient services, the date services are rendered in the outpatient department of the hospital.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(9)"> <text>“Designee” means any entity designated to act on behalf of the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses, if any, procedures performed, and age, sex, and discharge status of the participant.</text> </paragraph> <paragraph num="(11)"> <text>“Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction.</text> </paragraph> <paragraph num="(12)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital.</text> </paragraph> <paragraph num="(14)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(15)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(17)"> <text>“Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia.</text> </paragraph> <paragraph num="(18)"> <text>“Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission.</text> </paragraph> <paragraph num="(19)"> <text>“Participant” means an individual who is enrolled with the Department to receive Medical Assistance services.</text> </paragraph> <paragraph num="(20)"> <text>“Plan of treatment” means a written plan developed by a participant’s consulting physician and other appropriate clinicians, which is provided to the Department on request and includes:</text> <paragraph num="(a)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(c)"> <text>Specific procedures planned for the participant, including surgeries;</text> </paragraph> <paragraph num="(d)"> <text>Duration of treatment of each type of service ordered;</text> </paragraph> <paragraph num="(e)"> <text>Expected length of stay; and</text> </paragraph> <paragraph num="(f)"> <text>Any other appropriate information, including caregiver education and discharge plan.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(22)"> <text>“Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services.</text> </paragraph> <paragraph num="(23)"> <text>“Provider” means a special pediatric hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(24)"> <text>Special Pediatric Hospital.</text> <paragraph num="(a)"> <text>“Special pediatric hospital” means a facility licensed by the Office of Health Care Quality as a special hospital that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old.</text> </paragraph> <paragraph num="(b)"> <text>“Special pediatric hospital” includes an out-of-State or District of Columbia hospital identified by the Program as:</text> <paragraph num="(i)"> <text>A facility that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old; and</text> </paragraph> <paragraph num="(ii)"> <text>A facility that provides nonacute medical, rehabilitation, and therapy services to individuals ages 2 through 22 with co-occurring medical and behavioral conditions.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>In order to participate in the Program, a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain other licenses, as set forth in COMAR 10.07.01.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program as a special pediatric hospital services provider, the provider shall:</text> <paragraph num="(1)"> <text>Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services;</text> </paragraph> <paragraph num="(2)"> <text>Directly provide, or make available through contractual arrangements or transfer agreements, medically necessary covered services;</text> </paragraph> <paragraph num="(3)"> <text>Accept payment by the Program as payment in full for the covered services;</text> </paragraph> <paragraph num="(4)"> <text>Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>The participant’s chief medical complaint or reason for admission or outpatient visit;</text> </paragraph> <paragraph num="(c)"> <text>A description of the services provided, including:</text> <paragraph num="(i)"> <text>Progress notes;</text> </paragraph> <paragraph num="(ii)"> <text>Imaging studies;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory results;</text> </paragraph> <paragraph num="(iv)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(v)"> <text>Discharge summary; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If an out-of-State or District of Columbia hospital, the hospital shall:</text> <paragraph num="(1)"> <text>Have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XIX of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act unless a waiver has been granted by the Secretary of Health and Human Services; and</text> </paragraph> <paragraph num="(2)"> <text>Allow HealthChoice managed care organizations to pay no more and no less than the reimbursement rates established in Regulation .07 of this chapter unless the parties mutually agree to an alternative arrangement in a contract either on or after July 1, 2011.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the following inpatient services at special pediatric hospitals:</text> <paragraph num="(1)"> <text>A hospital admission determined to be medically necessary for a participant who is stable enough for transfer to a post-acute setting and requires medical or rehabilitative services that:</text> <paragraph num="(a)"> <text>Cannot be provided at a lower level of care; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the medical eligibility criteria under Regulation .06 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Administrative days for the length of time certified by the Department or its designee;</text> </paragraph> <paragraph num="(3)"> <text>Inpatient admissions for intensive occupational therapy, physical therapy, or speech therapy on a regimen which is less than 3 hours per day, 5 days per week, when these services are provided in a unit that is accredited by the Commission on Accreditation of Rehabilitation Facilities to provide rehabilitation services; and</text> </paragraph> <paragraph num="(4)"> <text>Ancillary services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers the following outpatient hospital services:</text> <paragraph num="(1)"> <text>Medically necessary services for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and</text> </paragraph> <paragraph num="(2)"> <text>For a participant younger than 21 years old, physical therapy, occupational therapy, speech therapy, and audiology services if:</text> <paragraph num="(a)"> <text>The therapy provider develops a written plan of treatment in collaboration with the participant’s primary care physician and the participant or the parent or guardian of the participant;</text> </paragraph> <paragraph num="(b)"> <text>The service is provided according to the plan of treatment; and</text> </paragraph> <paragraph num="(c)"> <text>The services provider sends an update of the plan of treatment to the participant’s primary care physician every 90 days.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <text>The Program does not cover:</text> <paragraph num="A."> <text>Investigational or experimental hospital services, procedures, or drugs;</text> </paragraph> <paragraph num="B."> <text>Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record;</text> </paragraph> <paragraph num="C."> <text>Outpatient visits intended to accomplish one or more of the following:</text> <paragraph num="(1)"> <text>Prescription drug or food supplement pick-up;</text> </paragraph> <paragraph num="(2)"> <text>Collection of specimens for laboratory procedures;</text> </paragraph> <paragraph num="(3)"> <text>Recording of an electrocardiogram; or</text> </paragraph> <paragraph num="(4)"> <text>Ascertaining the participant’s weight;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Interpretation of laboratory tests or panels;</text> </paragraph> <paragraph num="E."> <text>Autopsies;</text> </paragraph> <paragraph num="F."> <text>Immunizations required for travel outside the continental United States;</text> </paragraph> <paragraph num="G."> <text>Leaves of absence beyond the period of the census check of the same day;</text> </paragraph> <paragraph num="H."> <text>Day care;</text> </paragraph> <paragraph num="I."> <text>Psychological evaluations and treatments except when:</text> <paragraph num="(1)"> <text>Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or</text> </paragraph> <paragraph num="(2)"> <text>Performed as mental health service, as part of the plan of treatment;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Duplicated care or services;</text> </paragraph> <paragraph num="K."> <text>Elective admissions to hospitals outside of Maryland and the District of Columbia unless the Department or its designee determines that comparable services are not available in Maryland, except under certain conditions where child participants are in foster care, or are for other reasons placed outside the State and are covered under certain criteria, as determined by the Department or its designee;</text> </paragraph> <paragraph num="L."> <text>Inpatient and outpatient diagnostic services not specifically ordered by the attending physician or other responsible practitioner;</text> </paragraph> <paragraph num="M."> <text>Inpatient days or services provided in excess of the days approved by the Department or its designee;</text> </paragraph> <paragraph num="N."> <text>Hospital laboratory tests which are coverable under COMAR 10.09.09.04, if the specimen is not obtained in the hospital;</text> </paragraph> <paragraph num="O."> <text>Hospital services provided outside of the United States;</text> </paragraph> <paragraph num="P."> <text>The completion of forms and reports;</text> </paragraph> <paragraph num="Q."> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="R."> <text>Professional services rendered by mail or telephone; or</text> </paragraph> <paragraph num="S."> <text>Telephones, televisions, or personal comfort items or services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Utilization Review."> <paragraph num="A."> <text>The Department or its designee shall conduct utilization review to determine that special pediatric hospital admissions and outpatient services are authorized only when medically necessary.</text> </paragraph> <paragraph num="B."> <text>Review Procedure.</text> <paragraph num="(1)"> <text>For all admissions, the special pediatric hospital shall provide:</text> <paragraph num="(a)"> <text>The elements of a participant’s medical record specified by the Department or its designee for preadmission review, and request to certify the participant’s admission; and</text> </paragraph> <paragraph num="(b)"> <text>Sufficient clinical information or documentation to the Department or its designee that supports the need for admission to a special pediatric hospital including, but not limited to:</text> <paragraph num="(i)"> <text>Current medical health status;</text> </paragraph> <paragraph num="(ii)"> <text>Treatment received to date;</text> </paragraph> <paragraph num="(iii)"> <text>Proposed treatment plan for requested admission; and</text> </paragraph> <paragraph num="(iv)"> <text>Expected length of stay.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Admission for inpatient services may be authorized only when these services cannot be provided:</text> <paragraph num="(a)"> <text>On an outpatient basis; or</text> </paragraph> <paragraph num="(b)"> <text>In a facility that is licensed to provide a more appropriate level of care to the participant.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Concurrent review shall be conducted as long as the participant remains hospitalized, based on the participant’s diagnosis and condition, to ensure the medical necessity of the participant’s inpatient stay, at the following intervals:</text> <paragraph num="(a)"> <text>After an initially authorized 14-day stay, or at the end of the expected length of stay identified at admission, whichever comes first; and</text> </paragraph> <paragraph num="(b)"> <text>Every 14 days following the initial concurrent review, in a form and including clinical documentation as specified by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department or its designee may conduct on-site reviews after an initially authorized period of 30 days, and every 30 days thereafter until discharge.</text> </paragraph> <paragraph num="(5)"> <text>An elective inpatient hospital admission requires preadmission authorization by the Department or its designee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Administrative Days.</text> <paragraph num="(1)"> <text>To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below:</text> <paragraph num="(a)"> <text>The participant has been determined to no longer require special pediatric hospital services, and the provider has:</text> <paragraph num="(i)"> <text>Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available;</text> </paragraph> <paragraph num="(ii)"> <text>Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and</text> </paragraph> <paragraph num="(iii)"> <text>Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The participant is no longer medically eligible to receive special pediatric hospital services but cannot be moved, and the following conditions are met:</text> <paragraph num="(i)"> <text>The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record;</text> </paragraph> <paragraph num="(ii)"> <text>The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and</text> </paragraph> <paragraph num="(iii)"> <text>The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days.</text> </paragraph> <paragraph num="(3)"> <text>Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>HSCRC Reimbursement Principles.</text> <paragraph num="(1)"> <text>Except for hospitals reimbursed under the provisions of §B of this regulation and except for administrative days, hospitals located in Maryland that participate in the Program shall charge and be reimbursed according to rates approved by the HSCRC pursuant to COMAR 10.37.03.</text> </paragraph> <paragraph num="(2)"> <text>If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse a provider:</text> <paragraph num="(a)"> <text>According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or</text> </paragraph> <paragraph num="(b)"> <text>On the basis of charges if less than reasonable cost.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Annual Market Basket Reimbursement Principles.</text> <paragraph num="(1)"> <text>Except as specified in §B(2)—(5) of this regulation, a special pediatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost. In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs.</text> </paragraph> <paragraph num="(2)"> <text>For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system consisting of per diem rates based on service categories audited and adjusted in the provider’s fiscal year 2004 cost report. The base per diem rates shall be:</text> <paragraph num="(a)"> <text>Annually adjusted by the factor indicated in the Centers for Medicare and Medicaid Services Annual Market Basket Update Factor for the Long Term Care Hospital Prospective Payment System; and</text> </paragraph> <paragraph num="(b)"> <text>Determined by allocating Medicaid inpatient costs into service categories as follows:</text> <paragraph num="(i)"> <text>Rehabilitation categories — $1,486.58;</text> </paragraph> <paragraph num="(ii)"> <text>Feeding categories — $2,213.98;</text> </paragraph> <paragraph num="(iii)"> <text>Severe behavior categories — $2,544.66; and</text> </paragraph> <paragraph num="(iv)"> <text>Other categories — $1,126.69.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For new services established after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Program shall pay at an initial rate that is set as an interim rate at the Medicaid weighted average rate of all existing inpatient per diem rates. After the first full year, actual cost data shall be used to prospectively set the new service rate.</text> </paragraph> <paragraph num="(4)"> <text>For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse hospital based outpatient services on a prospective basis that shall be adjusted annually by the difference between the:</text> <paragraph num="(a)"> <text>Medicaid weighted average charge increase; and</text> </paragraph> <paragraph num="(b)"> <text>Centers for Medicare and Medicaid Services Outpatient Prospective Payment System Market Basket Update Factor.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For outpatient services in §B(4) of this regulation, the revenue shall be maintained at the fiscal year 2011 level beginning July 1, 2011.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Out-of-State Hospitals Reimbursement Principles.</text> <paragraph num="(1)"> <text>An out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. The hospital shall be reimbursed for administrative days in accordance with Regulation .09E of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>For outpatient services, an out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="District of Columbia Hospital Reimbursement."> <paragraph num="A."> <text>Inpatient Services Base Rate Calculation.</text> <paragraph num="(1)"> <text>A hospital in the District of Columbia shall:</text> <paragraph num="(a)"> <text>Bill its usual and customary charges; and</text> </paragraph> <paragraph num="(b)"> <text>Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The percentage of charges in §A(1) of this regulation is the product of the following:</text> <paragraph num="(a)"> <text>The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee;</text> </paragraph> <paragraph num="(b)"> <text>The lesser of 100 percent or the cost-to-charge projection percentage which is:</text> <paragraph num="(i)"> <text>The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and</text> </paragraph> <paragraph num="(ii)"> <text>Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The percentage of the hospital’s costs which are efficiently and economically incurred as determined in accordance with §A(6) of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>The uncompensated care factor, which is equal to one plus the quotient of the hospital’s uncompensated care divided by gross revenue.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent.</text> </paragraph> <paragraph num="(4)"> <text>A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .08C of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>Efficiently and economically incurred District of Columbia hospitals’ costs are costs which are:</text> <paragraph num="(a)"> <text>Less than or equal to the adjusted costs for the same all participant refined-diagnosis related groups in Maryland hospitals;</text> </paragraph> <paragraph num="(b)"> <text>For hospitals with average lengths of stay of 18 days or more:</text> <paragraph num="(i)"> <text>Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and</text> </paragraph> <paragraph num="(ii)"> <text>Categorized into the following two age groups: younger than 18 years old, and 18 years old or older;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Exclusive of:</text> <paragraph num="(i)"> <text>Maryland case charges greater than $500,000; and</text> </paragraph> <paragraph num="(ii)"> <text>District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Derived from hospital costs as specified in this subsection.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Maryland hospital costs are the hospitals’ charges reduced by the hospital specific ratio of operating costs to gross charges as determined by the Program or designee.</text> </paragraph> <paragraph num="(7)"> <text>There may not be a year-end cost settlement.</text> </paragraph> <paragraph num="(8)"> <text>For hospitals located in the District of Columbia that are not acute children’s hospitals, the reimbursement amount described in §A(1) of this regulation will be reduced by 2 percent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Outpatient Services.</text> <paragraph num="(1)"> <text>A hospital located in the District of Columbia shall:</text> <paragraph num="(a)"> <text>Bill its usual and customary charges; and</text> </paragraph> <paragraph num="(b)"> <text>Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The percentage of charges in §B(1) of this regulation is the product of:</text> <paragraph num="(a)"> <text>The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and</text> </paragraph> <paragraph num="(b)"> <text>The lesser of 100 percent or the cost-to-charge projection percentage which is:</text> <paragraph num="(i)"> <text>The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and</text> </paragraph> <paragraph num="(ii)"> <text>Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent.</text> </paragraph> <paragraph num="(4)"> <text>The analysis shall be performed by the Program or its designee.</text> </paragraph> <paragraph num="(5)"> <text>There may not be a year-end cost settlement.</text> </paragraph> <paragraph num="(6)"> <text>Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Cost Reporting.</text> <paragraph num="(1)"> <text>A special pediatric hospital provider reimbursed according to this regulation shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="(2)"> <text>When reports are not received within 5 months and an extension has not been granted:</text> <paragraph num="(a)"> <text>For hospitals reimbursed in accordance with Regulation .08 of this chapter, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or</text> </paragraph> <paragraph num="(b)"> <text>For a hospital reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall:</text> <paragraph num="(i)"> <text>Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and</text> </paragraph> <paragraph num="(ii)"> <text>Refund withholdings at cost settlement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="(4)"> <text>The Program may grant an extension for submission of cost reports:</text> <paragraph num="(a)"> <text>Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or</text> </paragraph> <paragraph num="(b)"> <text>Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year, and the provider has not received an extension, the Department may impose, in addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, one or more sanctions as provided for in Regulation .11 of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>When a report is not submitted by the last day of the sixth month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled.</text> </paragraph> <paragraph num="(7)"> <text>For purposes of §C(1) — (6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> <paragraph num="(8)"> <text>When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using this cost report information shall be implemented starting the 1st day of the 4th full calendar month after the month in which the report was received by the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Billing and Reimbursement Principles."> <paragraph num="A."> <text>The Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital.</text> </paragraph> <paragraph num="B."> <text>The provider shall submit a request for payment according to procedures designated by the Department.</text> </paragraph> <paragraph num="C."> <text>Payments of Medicare Claims.</text> <paragraph num="(1)"> <text>Payment of Medicare claims is authorized if:</text> <paragraph num="(a)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(b)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(c)"> <text>Medicare determined that services were medically necessary;</text> </paragraph> <paragraph num="(d)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(e)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Payment of a deductible and co-insurance related to Medicare claims shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Out-of-State Hospital Reimbursement.</text> <paragraph num="(1)"> <text>The Program shall reimburse hospitals outside of Maryland, excluding the District of Columbia, at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less.</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State providers are responsible for reimbursing the Department for overpayments, in accordance with Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment for Administrative Days.</text> <paragraph num="(1)"> <text>The provider shall document, on forms designated by the Department, information that satisfies the conditions stated in Regulation .06C of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall:</text> <paragraph num="(a)"> <text>Receive determination from the Department or its designee that the participant no longer requires the level of care that the special pediatric hospital is licensed to provide;</text> </paragraph> <paragraph num="(b)"> <text>Receive determination from the Department or its designee that the participant requires services at a lower level of acuity, and a bed in an appropriate facility is not available; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the Department or its designee of discharge planning before the termination of the need for inpatient hospitalization at the level the facility is licensed to provide, and obtained a level of care determination from the agent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>During the period of administrative days, the Department or its designee shall review the documentation in increments of not more than 14 days.</text> </paragraph> <paragraph num="G."> <text>For participants who are not ventilator-dependent, payment for approved administrative days shall be the lesser of:</text> <paragraph num="(1)"> <text>An estimated Statewide average Medicaid nursing home payment rate as determined by the Department; or</text> </paragraph> <paragraph num="(2)"> <text>If the hospital has a unit which is a skilled nursing facility, the allowable costs in effect under Medicare or extended services provided to participants of the unit.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department will make no direct payment to the participant.</text> </paragraph> <paragraph num="I."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="J."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> <paragraph num="K."> <text>Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim.</text> </paragraph> <paragraph num="L."> <text>Payment on claims to a hospital located in the District of Columbia shall be reduced by a quarterly claims processing fee of 6 percent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07.</text> </paragraph> <paragraph num="B."> <text>If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeal Procedures."> <text>A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations that are applicable to providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2017 (44:7 Md. R. 354)</annotation> </annotations> </chapter> <chapter num="95" heading="Special Psychiatric Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care which the provider is licensed to deliver and is awaiting placement in a nursing home or residential care facility.</text> </paragraph> <paragraph num="(2)"> <text>“Admission” means the formal acceptance by a specialty psychiatric hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight.</text> </paragraph> <paragraph num="(3)"> <text>“Ancillary services” means diagnostic and therapeutic services, provided exclusive of room and board, including but not limited to:</text> <paragraph num="(a)"> <text>Radiology;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory tests;</text> </paragraph> <paragraph num="(c)"> <text>Pharmacy services; and</text> </paragraph> <paragraph num="(d)"> <text>Physical therapy services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Appropriate facility” means:</text> <paragraph num="(a)"> <text>A facility located within a 25-mile radius of the participant’s residence; or</text> </paragraph> <paragraph num="(b)"> <text>If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Concurrent review” means a periodic reauthorization of continued eligibility for the level of services provided by a special psychiatric hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization.</text> </paragraph> <paragraph num="(6)"> <text>“Date of service” means:</text> <paragraph num="(a)"> <text>For inpatient hospitalizations, the date of admission into a special psychiatric hospital up to, but not including, the date of discharge;</text> </paragraph> <paragraph num="(b)"> <text>For outpatient services, the date services are rendered in the outpatient department of the special psychiatric hospital; and</text> </paragraph> <paragraph num="(c)"> <text>For observation services, the date or dates the services are rendered in a special psychiatric hospital, which are ordered by a medical staff practitioner to determine the need for inpatient admission.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Department” means the State Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text> </paragraph> <paragraph num="(8)"> <text>“Designee” means any entity designated to act on behalf of the Department.</text> </paragraph> <paragraph num="(9)"> <text>“Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction.</text> </paragraph> <paragraph num="(10)"> <text>“Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment of bodily functions; or</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital.</text> </paragraph> <paragraph num="(13)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(14)"> <text>“Medicaid” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(15)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the participant, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(17)"> <text>“Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat the diagnoses set forth in COMAR 10.09.70.02.</text> </paragraph> <paragraph num="(18)"> <text>“Nonqualified alien” means a foreign-born resident who:</text> <paragraph num="(a)"> <text>Is not a naturalized U.S. citizen; and</text> </paragraph> <paragraph num="(b)"> <text>Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Observation services” means the medically necessary diagnostic services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient special psychiatric care setting.</text> </paragraph> <paragraph num="(20)"> <text>“Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver.</text> </paragraph> <paragraph num="(21)"> <text>“Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia.</text> </paragraph> <paragraph num="(22)"> <text>“Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission.</text> </paragraph> <paragraph num="(23)"> <text>“Partial hospitalization” means outpatient, intensive, nonresidential psychiatric treatment, which is an alternative to inpatient acute general hospitalization, for any part of a 24-hour day for a minimum of 4 consecutive hours per day.</text> </paragraph> <paragraph num="(24)"> <text>“Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits.</text> </paragraph> <paragraph num="(25)"> <text>“Patient” means an individual awaiting or undergoing health care or treatment.</text> </paragraph> <paragraph num="(26)"> <text>“Plan of treatment” means a written plan, developed to address the referred problem or problems, which includes:</text> <paragraph num="(a)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Treatment goals;</text> </paragraph> <paragraph num="(c)"> <text>Frequency of visits for each type of service ordered;</text> </paragraph> <paragraph num="(d)"> <text>Duration of treatment of each type of service ordered;</text> </paragraph> <paragraph num="(e)"> <text>Prognosis; and</text> </paragraph> <paragraph num="(f)"> <text>Other appropriate items.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed.</text> </paragraph> <paragraph num="(28)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(29)"> <text>“Provider” means a special psychiatric hospital which through agreement with the Department has been identified as a Program provider by the issuance of a provider number.</text> </paragraph> <paragraph num="(30)"> <text>“Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital.</text> </paragraph> <paragraph num="(31)"> <text>“Special psychiatric hospital” means an institution that:</text> <paragraph num="(a)"> <text>Provides short-term services for psychiatric illnesses in a hospital setting with facilities, medical staff, and all necessary personnel to provide diagnosis, care, and treatment;</text> </paragraph> <paragraph num="(b)"> <text>Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Requirements."> <paragraph num="A."> <text>In order to participate in the Program, a provider shall:</text> <paragraph num="(1)"> <text>Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a specialty psychiatric hospital; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain other licenses, as set forth in COMAR 10.07.01.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:</text> <paragraph num="(1)"> <text>If located in Maryland, comply with requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.</text> </paragraph> <paragraph num="B."> <text>To participate in the Program as a special psychiatric hospital services provider, the provider shall:</text> <paragraph num="(1)"> <text>Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services;</text> </paragraph> <paragraph num="(2)"> <text>Meet the following staffing requirements 24 hours per day, 7 days per week:</text> <paragraph num="(a)"> <text>On-call or on-site physician services including psychiatric physicians;</text> </paragraph> <paragraph num="(b)"> <text>On-site registered nurses;</text> </paragraph> <paragraph num="(c)"> <text>On-site advanced cardiac life support services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If licensed to provide inpatient psychiatric services for individuals younger than 21 years old:</text> <paragraph num="(a)"> <text>Meet the requirements for participation as defined in 42 CFR §440.160; and</text> </paragraph> <paragraph num="(b)"> <text>Provide acute psychiatric services as defined in 42 CFR Part 441, Subpart D;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services;</text> </paragraph> <paragraph num="(5)"> <text>Accept payment by the Program as payment in full for the covered service;</text> </paragraph> <paragraph num="(6)"> <text>Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay;</text> </paragraph> <paragraph num="(7)"> <text>Maintain documentation of each contact with the participant as part of the medical record, which, at a minimum, includes:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>A plan of treatment as defined in Regulation .01B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>The participant’s chief medical complaint or reason for visit;</text> </paragraph> <paragraph num="(d)"> <text>A description of the services provided, including:</text> <paragraph num="(i)"> <text>Progress notes;</text> </paragraph> <paragraph num="(ii)"> <text>Imaging studies;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory results;</text> </paragraph> <paragraph num="(iv)"> <text>Medication administration records; and</text> </paragraph> <paragraph num="(v)"> <text>Discharge summary; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Submit to the Department or its designee within 5 months of the close of the hospital’s fiscal year, as required by the Department, a hospital cost report for outpatient services which are subject to cost settlement in accordance with Regulation .11 of this chapter;</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an out-of-State or District of Columbia hospital, the special psychiatric hospital shall:</text> <paragraph num="(1)"> <text>Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with applicable regulations of this chapter and COMAR 10.09.36.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Program covers the following inpatient special psychiatric hospital services:</text> <paragraph num="(1)"> <text>Medically necessary services for the number of days, per admission, including days certified by the Department or its designee;</text> </paragraph> <paragraph num="(2)"> <text>Medically necessary mental health services authorized in accordance with COMAR 10.09.59.08 and as set forth in Regulation .05B(4) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Medically necessary services when these services are:</text> <paragraph num="(a)"> <text>Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Described in the participant’s medical record in sufficient detail to support the invoices submitted for services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Administrative days for the length of time certified by the Department or its designee;</text> </paragraph> <paragraph num="(5)"> <text>Leaves of absence for therapeutic reasons or extenuating circumstances up to 12 hours per day, if the participant returns the same day, before the census check; and</text> </paragraph> <paragraph num="(6)"> <text>Observation services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program covers partial hospitalization when the hospital has:</text> <paragraph num="(1)"> <text>Written approval from the Office of Licensing and Certification Programs to be a provider of partial hospitalization in accordance with COMAR 10.21.02;</text> </paragraph> <paragraph num="(2)"> <text>A certificate of need from the Maryland Health Resources Planning Commission, if required, to be a provider of partial hospitalization; and</text> </paragraph> <paragraph num="(3)"> <text>Obtained preauthorization in accordance with COMAR 10.09.59.08.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations."> <paragraph num="A."> <text>There are limitations placed on the coverage of some special psychiatric hospital inpatient and outpatient services.</text> </paragraph> <paragraph num="B."> <text>The Program does not cover:</text> <paragraph num="(1)"> <text>Special psychiatric hospital services, procedures, drugs or admissions that are investigational or experimental;</text> </paragraph> <paragraph num="(2)"> <text>Services identified by the Department or its designee as not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Elective inpatient admissions without preauthorization;</text> </paragraph> <paragraph num="(4)"> <text>Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record;</text> </paragraph> <paragraph num="(5)"> <text>Inpatient mental health services for an individual between 21 and 64 in a special psychiatric hospital of more than 16 beds that primarily engages in providing mental health services for an individual who is not waiver-eligible, as defined in COMAR 10.67.01.01, except:</text> <paragraph num="(a)"> <text>When receiving mental health services in the special psychiatric hospital immediately before the participant reached 21 years old, in which case the services may be continued until the earlier of the following:</text> <paragraph num="(i)"> <text>The date the participant no longer requires the services; or</text> </paragraph> <paragraph num="(ii)"> <text>The date the participant reaches 22 years old;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective July 1, 2019, services of up to 15 days per month, when:</text> <paragraph num="(i)"> <text>The participant has co-occurring substance use and mental health diagnoses; and</text> </paragraph> <paragraph num="(ii)"> <text>The provider is located in-State or, effective January 1, 2022, the provider is located in a contiguous state or the District of Columbia; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Effective January 1, 2022, services up to 60 days, when:</text> <paragraph num="(i)"> <text>The participant has a primary mental health diagnosis; and</text> </paragraph> <paragraph num="(ii)"> <text>The provider is located in-State, a contiguous state, or the District of Columbia;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Outpatient visits for one or more of the following:</text> <paragraph num="(a)"> <text>Prescription drug or food supplement pick up;</text> </paragraph> <paragraph num="(b)"> <text>Collection of specimens for laboratory procedures;</text> </paragraph> <paragraph num="(c)"> <text>Recording of an electrocardiogram;</text> </paragraph> <paragraph num="(d)"> <text>Ascertaining the participant’s weight; and</text> </paragraph> <paragraph num="(e)"> <text>Administration of vaccines;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Leaves of absence beyond the period of the census check of the same day;</text> </paragraph> <paragraph num="(8)"> <text>Psychological evaluations and treatments except when:</text> <paragraph num="(a)"> <text>Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or</text> </paragraph> <paragraph num="(b)"> <text>Performed as mental health services as part of an approved treatment plan;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Telephones, televisions, or personal comfort items or services;</text> </paragraph> <paragraph num="(10)"> <text>Duplicated care or service as indicated by more than one charge for the same stay or more than one room accommodation for the same time, for example, a charge for an inpatient day and observation room charge;</text> </paragraph> <paragraph num="(11)"> <text>Administrative days for participants pending discharge to home or nonmedical institutions;</text> </paragraph> <paragraph num="(12)"> <text>Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner;</text> </paragraph> <paragraph num="(13)"> <text>Inpatient days provided in excess of the days approved by the Department or its designee;</text> </paragraph> <paragraph num="(14)"> <text>Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital;</text> </paragraph> <paragraph num="(15)"> <text>Admissions to special psychiatric hospitals, unless the participant is diagnosed with any one of the specialty mental health codes listed in COMAR 10.09.70.02 or unless the Department or its designee grants a special exception based on the complexity of the situation at admission; or</text> </paragraph> <paragraph num="(16)"> <text>Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Utilization Review Requirements."> <paragraph num="A."> <text>Elective Inpatient Preauthorization Reviews.</text> <paragraph num="(1)"> <text>The special psychiatric hospital shall only request preauthorization for inpatient stays when such services:</text> <paragraph num="(a)"> <text>Cannot be provided on an outpatient basis; or</text> </paragraph> <paragraph num="(b)"> <text>Can only be provided in a facility that is licensed as a special psychiatric hospital.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The special psychiatric hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to:</text> <paragraph num="(a)"> <text>Participant’s medical history and physical; and</text> </paragraph> <paragraph num="(b)"> <text>Sufficient clinical information or documentation that supports the medical necessity of the inpatient admission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Review Process.</text> <paragraph num="(1)"> <text>The concurrent review process shall be initiated by the hospital.</text> </paragraph> <paragraph num="(2)"> <text>If the participant remains hospitalized, additional days shall be certified by the Department or its designee before the termination of the previously certified days.</text> </paragraph> <paragraph num="(3)"> <text>The special psychiatric hospital shall forward sufficient clinical information or documentation to the Department or its designee that supports the need for continuing care. Information submitted shall include:</text> <paragraph num="(a)"> <text>Current health status;</text> </paragraph> <paragraph num="(b)"> <text>Treatment received to date;</text> </paragraph> <paragraph num="(c)"> <text>Proposed treatment plan for continued stay; and</text> </paragraph> <paragraph num="(d)"> <text>Discharge planning.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Retrospective Reviews.</text> <paragraph num="(1)"> <text>The special psychiatric hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission.</text> </paragraph> <paragraph num="(2)"> <text>The special psychiatric hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from a special psychiatric hospital. Documentation submitted shall include, but is not limited to:</text> <paragraph num="(a)"> <text>The participant’s complete medical record;</text> </paragraph> <paragraph num="(b)"> <text>The principal, secondary, and tertiary diagnoses; and</text> </paragraph> <paragraph num="(c)"> <text>All relevant procedure codes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient special psychiatric hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall compare the current rates with the projected upper payment limit for inpatient days of service on or after July 1, 2012, in freestanding private psychiatric hospitals in Maryland whose rates for commercial providers are set by the HSCRC.</text> </paragraph> <paragraph num="(3)"> <text>If the rates do not exceed the projected upper payment limit calculated by the Department, the Department shall reimburse these hospitals using a rate of 94 percent of the current rates for services set by the HSCRC for each hospital’s commercial providers in the fiscal year the prospective payments are made.</text> </paragraph> <paragraph num="(4)"> <text>If the rates do exceed the projected upper payment limit calculated by the Department, the per diem payments to each such hospital shall be decreased by the same proportion that the projected upper payment limit is exceeded.</text> </paragraph> <paragraph num="(5)"> <text>If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers:</text> <paragraph num="(a)"> <text>According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or</text> </paragraph> <paragraph num="(b)"> <text>On the basis of charges if less than reasonable cost.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item. When HSCRC has included these salaries in the hospital’s costs, charges for these services shall be included in the room and board rate or the appropriate ancillary service only.</text> </paragraph> <paragraph num="(7)"> <text>Payment advances other than those made in accordance with HSCRC regulations may not be made routinely.</text> </paragraph> <paragraph num="(8)"> <text>Inpatient and outpatient services in District of Columbia special psychiatric and outpatient services in in-State special psychiatric hospitals are cost-settled on an annual basis according to §B of this regulation.</text> </paragraph> <paragraph num="(9)"> <text>Effective October 1, 2018, an out-of-State special psychiatric hospital shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency.</text> </paragraph> <paragraph num="(10)"> <text>An out-of-State provider shall submit proof of host state rates on an annual basis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Retrospective Cost Reimbursement.</text> <paragraph num="(1)"> <text>Except as specified in §A of this regulation, a special psychiatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed:</text> <paragraph num="(a)"> <text>According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or</text> </paragraph> <paragraph num="(b)"> <text>On the basis of charges, if less than reasonable cost.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments thus resulting in a reduction of allowable costs.</text> </paragraph> <paragraph num="(3)"> <text>Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base-year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year.</text> </paragraph> <paragraph num="(4)"> <text>Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be:</text> <paragraph num="(a)"> <text>For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; and</text> </paragraph> <paragraph num="(b)"> <text>For a new provider, or all of these, the 12-month period immediately before the provider was initially subjected to target rate increases.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, at least 90 days before the beginning of billing for services, the following:</text> <paragraph num="(a)"> <text>A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate;</text> </paragraph> <paragraph num="(b)"> <text>A current, projected, and prior year’s charge rate schedule;</text> </paragraph> <paragraph num="(c)"> <text>Finalized prior year’s Medicare cost reports and the most current submission;</text> </paragraph> <paragraph num="(d)"> <text>A detailed revenue schedule; and</text> </paragraph> <paragraph num="(e)"> <text>Audited financial statements.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services.</text> </paragraph> <paragraph num="(7)"> <text>Initial Interim Rates for Newly Established Services or Providers.</text> <paragraph num="(a)"> <text>The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate that follows Medicare principles and cost finding.</text> </paragraph> <paragraph num="(b)"> <text>The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Revision of Interim Rates.</text> <paragraph num="(a)"> <text>The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent.</text> </paragraph> <paragraph num="(b)"> <text>The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and other any other information that supports the rate increase.</text> </paragraph> <paragraph num="(c)"> <text>The Department will lower the provider’s interim rate to approximate the final allowable reasonable cost based on the results of the prior year’s review.</text> </paragraph> <paragraph num="(d)"> <text>The provider may request not more than two interim rate revisions during the accounting year.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Cost Settlement.</text> <paragraph num="(a)"> <text>The provider shall submit to the Department or its designee:</text> <paragraph num="(i)"> <text>A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement;</text> </paragraph> <paragraph num="(ii)"> <text>A copy of the provider’s Program log; and</text> </paragraph> <paragraph num="(iii)"> <text>A finalized Medicare cost report for the cost reporting year.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The final Program cost report shall be sufficiently detailed to support a separate cost finding for Maryland Medical Assistance unique cost centers. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers.</text> </paragraph> <paragraph num="(c)"> <text>Tentative cost settlements may not be performed on a routine basis. However, the Program may, when it determines appropriate, calculate tentative settlements. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year.</text> </paragraph> <paragraph num="(d)"> <text>The Department will base final settlement on the results of the finalized Medicare cost reports.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall reimburse room and board charges for the day of admission, but may not reimburse room and board charges for the day of discharge from the hospital.</text> </paragraph> <paragraph num="D."> <text>The provider shall submit request for payment according to procedures established by the Department.</text> </paragraph> <paragraph num="E."> <text>Payments on Medicare claims are authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignment;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Medicare determined the services were medically necessary;</text> </paragraph> <paragraph num="(4)"> <text>The services are covered by the Program; and</text> </paragraph> <paragraph num="(5)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payment on Medicare claims is subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible and co-insurance, according to the limits of §E of this regulation, shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full; or</text> </paragraph> <paragraph num="(2)"> <text>Services not covered by Medicare, but by the Program, if medically justified according to §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Administrative Days.</text> <paragraph num="(1)"> <text>To be paid for administrative days, the special psychiatric hospital shall document, on forms designated by the Department, information demonstrating that the participant who was initially eligible has been determined to no longer require special psychiatric hospital services and the provider has:</text> <paragraph num="(a)"> <text>Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available;</text> </paragraph> <paragraph num="(b)"> <text>Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record;</text> </paragraph> <paragraph num="(c)"> <text>Maintained documentation in the participant’s medical record that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; and</text> </paragraph> <paragraph num="(d)"> <text>Notified the local agency responsible for development of the discharge treatment and education plan of the potential placement, if the participant is at risk of a residential treatment center placement on admission;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the participant requires the level of care provided by a residential treatment center and a bed in a residential treatment center is not available, in order to be paid for administrative days, the special psychiatric hospital shall document that it timely notified local coordinating councils and any other local agency, as appropriate, of the necessity to continue inpatient psychiatric service at a residential treatment center before the termination of the need for inpatient psychiatric hospitalization;</text> </paragraph> <paragraph num="(3)"> <text>If the participant is at an inappropriate level of care but cannot be moved, in order to be paid for administrative days, the special psychiatric hospital shall:</text> <paragraph num="(a)"> <text>Provide the attending physician’s declaration that, because of physical or emotional problems, the participant is unable to be moved;</text> </paragraph> <paragraph num="(b)"> <text>Document in the participant’s medical record the attending physician’s reasons why the participant cannot be moved; and</text> </paragraph> <paragraph num="(c)"> <text>Document the attending physician’s reevaluation of the participant’s inability to be moved in the participant’s record at least every 14 days in special psychiatric hospital.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Payment for approved administrative days for a special psychiatric hospital seeking placement of a participant to a residential treatment center shall be the average residential treatment center rate issued pursuant to COMAR 10.09.29.13B.</text> </paragraph> <paragraph num="I."> <text>The Department may not reimburse a special psychiatric hospital for administrative days if:</text> <paragraph num="(1)"> <text>The special psychiatric hospital bills the Program for days of care for which the hospital is licensed to provide; or</text> </paragraph> <paragraph num="(2)"> <text>The Program or the Program’s designee determines the participant no longer requires the level of care for the days requested.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Department may not make direct payment to the participant.</text> </paragraph> <paragraph num="K."> <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06.</text> </paragraph> <paragraph num="L."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly completed.</text> </paragraph> <paragraph num="M."> <text>Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07.</text> </paragraph> <paragraph num="B."> <text>If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Submitting Cost Reports."> <paragraph num="A."> <text>The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program.</text> </paragraph> <paragraph num="B."> <text>For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall:</text> <paragraph num="(1)"> <text>Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and</text> </paragraph> <paragraph num="(2)"> <text>Refund withholdings at cost settlement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination.</text> </paragraph> <paragraph num="D."> <text>The Program shall grant an extension for submission of cost reports:</text> <paragraph num="(1)"> <text>Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or</text> </paragraph> <paragraph num="(2)"> <text>Concurrent with any extension granted to the special psychiatric hospital by Medicare, but not to exceed 60 days from the due date of cost reports.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="F."> <text>When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled.</text> </paragraph> <paragraph num="G."> <text>For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Cost Settlement."> <paragraph num="A."> <text>The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .07 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal.</text> </paragraph> <paragraph num="C."> <text>The provider may request review of the settlement under Regulation .07 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee.</text> </paragraph> <paragraph num="D."> <text>The Appeal Board shall be composed of the following:</text> <paragraph num="(1)"> <text>A representative of the hospital industry who is:</text> <paragraph num="(a)"> <text>Knowledgeable in Medicare and Medicaid reimbursement principles; and</text> </paragraph> <paragraph num="(b)"> <text>Appointed by the Secretary of the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual who:</text> <paragraph num="(a)"> <text>Is employed by the State;</text> </paragraph> <paragraph num="(b)"> <text>Is knowledgeable in Medicare and Medicaid reimbursement principles;</text> </paragraph> <paragraph num="(c)"> <text>Did not participate in the verification of costs; and</text> </paragraph> <paragraph num="(d)"> <text>Is appointed by the Secretary of the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A third member selected by the first two members of the Appeal Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member.</text> </paragraph> <paragraph num="F."> <text>If the provider elects not to appeal to the Appeal Board, the provider shall:</text> <paragraph num="(1)"> <text>Pay the amount due within 60 days after the notification described in §A of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Request a longer payment schedule within 60 days after the provider receives notification of the amount due to the Program.</text> </paragraph> </paragraph> <paragraph num="G."> <text>After consultation with the provider, the Department may establish a longer payment schedule if it determines, based on sufficient documentation submitted by the provider, that failure to grant a longer payment schedule would:</text> <paragraph num="(1)"> <text>Result in financial hardship to the provider; or</text> </paragraph> <paragraph num="(2)"> <text>Have an adverse effect on the quality of participant care furnished by the facility.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the provider elects to appeal to the Appeal Board, the following provisions apply:</text> <paragraph num="(1)"> <text>Within 30 days after the filing of an appeal by a provider that the Department or its designee determined owes money to the Program, the Department or its designee shall:</text> <paragraph num="(a)"> <text>Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed;</text> </paragraph> <paragraph num="(3)"> <text>Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and</text> </paragraph> <paragraph num="(4)"> <text>If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Appeal Board Findings.</text> <paragraph num="(1)"> <text>After the Department receives the findings of the Appeal Board, the Department shall:</text> <paragraph num="(a)"> <text>Determine the amount that is due either to the Program or to the provider; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the provider of that amount.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The portion of the amount in controversy that is paid is subject to an award of interest that is:</text> <paragraph num="(a)"> <text>Calculated from the date the appeal was filed through the date of payment; and</text> </paragraph> <paragraph num="(b)"> <text>Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs.</text> </paragraph> <paragraph num="(4)"> <text>If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any.</text> </paragraph> <paragraph num="(5)"> <text>Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any.</text> </paragraph> <paragraph num="(6)"> <text>If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—I of this regulation, and in addition to the sanctions provided in Regulation .09 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider.</text> </paragraph> <paragraph num="K."> <text>The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the Appeal Board’s decision as the final agency decision under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland.</text> </paragraph> <paragraph num="L."> <text>If the provider or the Department appeals a final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination.</text> </paragraph> <paragraph num="M."> <text>The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2017 (44:7 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective September 9, 2019 (46:18 Md. R. 774); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective December 31, 2018 (45:26 Md. R. 1245)</annotation> </annotations> </chapter> <chapter num="96" heading="Remote Patient Monitoring"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter applies to remote patient monitoring services reimbursed by the Maryland Medical Assistance Program effective January 1, 2018.</text> </paragraph> <paragraph num="B."> <text>The purpose of providing medically necessary services via remote patient monitoring is to assist participants in managing and controlling their chronic conditions in order to reduce readmissions and emergency department visits and to improve quality of care</text> </paragraph> <paragraph num="C."> <text>The target populations are high-risk Maryland Medical Assistance Program participants with a chronic disease capable of monitoring via remote patient monitoring.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certified nurse midwife” means an individual who meets the licensure and conditions of participation for certified nurse midwives set forth in COMAR 10.09.01.</text> </paragraph> <paragraph num="(2)"> <text>“Certified nurse practitioner” means an individual who meets the licensure and conditions of participation for certified nurse practitioners set forth in COMAR 10.09.01.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the</text> </paragraph> <paragraph num="(4)"> <text>“Episode” means the span of treatment during which remote patient monitoring services are rendered to eligible participants.</text> </paragraph> <paragraph num="(5)"> <text>“Home” means the place of residence occupied by the participant, other than a hospital, nursing facility, or other medical or psychiatric institution.</text> </paragraph> <paragraph num="(6)"> <text>“Home health agency" means a public or private agency or organization that meets the licensure requirements and conditions of participation of COMAR 10.09.04.</text> </paragraph> <paragraph num="(7)"> <text>“Maryland Medical Assistance Program” means the program of comprehensive medical, behavioral, and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended.</text> </paragraph> <paragraph num="(8)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, family, or provider.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text> </paragraph> <paragraph num="(10)"> <text>“Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02.</text> </paragraph> <paragraph num="(11)"> <text>“Physician assistant” means an individual who meets the licensure requirements and conditions of participation set forth in COMAR 10.09.55.</text> </paragraph> <paragraph num="(12)"> <text>“Program” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(13)"> <text>“Provider” means an individual or an organization who:</text> <paragraph num="(a)"> <text>Meets the requirements of Regulations .03 and .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of a unique provider number.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Remote patient monitoring” means the use of synchronous or asynchronous digital technologies that collect or monitor medical, patient-reported, and other forms of health care data for Program participants at an originating site and electronically transmit that data to a distant site provider to enable the distant site provider to assess, diagnose, consult, treat, educate, provide care management, suggest self-management, or make recommendations regarding the Program participant’s health care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Requirements."> <paragraph num="A."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Meet all license requirements as set forth in COMAR 10.09.36.02; and</text> </paragraph> <paragraph num="(2)"> <text>Be licensed in the state in which the participant resides.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A home health agency shall be:</text> <paragraph num="(1)"> <text>Licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>Legally authorized to provide home health services in the jurisdiction in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided.</text> </paragraph> <paragraph num="D."> <text>A certified nurse practitioner shall:</text> <paragraph num="(1)"> <text>Hold a current license to practice registered nursing in Maryland, and be certified as a nurse practitioner by the Nursing Board; or</text> </paragraph> <paragraph num="(2)"> <text>Meet the nurse practitioner regulatory requirements of the state in which the services are provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A physician assistant applying for provider status shall:</text> <paragraph num="(1)"> <text>Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Be in compliance with requirements set forth in COMAR 10.32.03;</text> </paragraph> <paragraph num="(3)"> <text>If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and</text> </paragraph> <paragraph num="(4)"> <text>If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Provider Conditions for Participation."> <paragraph num="A."> <text>To provide remote patient monitoring, the provider shall:</text> <paragraph num="(1)"> <text>Be enrolled with an active status as a Maryland Medical Assistance Program provider on the date the service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Be a:</text> <paragraph num="(a)"> <text>Physician;</text> </paragraph> <paragraph num="(b)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(c)"> <text>Certified nurse practitioner; or</text> </paragraph> <paragraph num="(d)"> <text>Home health agency when remote patient monitoring services are prescribed by a physician; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Meet the requirements for participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Record Documentation. A remote patient monitoring provider shall:</text> <paragraph num="(1)"> <text>Maintain documentation using either electronic or paper medical records;</text> </paragraph> <paragraph num="(2)"> <text>Retain remote patient monitoring records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Submit the preauthorization on a form developed by the Department; and</text> </paragraph> <paragraph num="(4)"> <text>Include the participant’s consent to participate in remote patient monitoring.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Remote patient monitoring is not a substitute for delivery of care. Provider shall see patients in person periodically for follow-up care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Participant Eligibility for Services."> <text>A participant is eligible to receive remote patient monitoring services if:</text> <paragraph num="A."> <text>The participant is enrolled in the Maryland Medical Assistance Program on the date the service is rendered;</text> </paragraph> <paragraph num="B."> <text>The participant consents to remote patient monitoring services and has the capability to utilize the monitoring tools and take actions to improve self-management of the chronic disease;</text> </paragraph> <paragraph num="C."> <text>The participant has the internet connections necessary to host the equipment in the home;</text> </paragraph> <paragraph num="D."> <text>The participant is at risk for avoidable hospital utilization due to a poorly controlled chronic disease capable of being monitored via remote patient monitoring; and</text> </paragraph> <paragraph num="E."> <text>The provision of remote patient monitoring may reduce the risk of preventable hospital utilization and promote improvement in control of the chronic condition</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>Remote patient monitoring services include:</text> <paragraph num="(1)"> <text>Installation;</text> </paragraph> <paragraph num="(2)"> <text>Education for the participant in the use of the equipment; and</text> </paragraph> <paragraph num="(3)"> <text>Daily monitoring of vital signs and other medical statistics.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The remote patient monitoring provider shall establish an intervention process to address abnormal data measurements in an effort to prevent avoidable hospital utilization.</text> </paragraph> <paragraph num="C."> <text>Physician, nurse practitioner, and physician assistant providers who establish remote patient monitoring programs shall be responsible for:</text> <paragraph num="(1)"> <text>Establishing criteria for reporting abnormal measurements;</text> </paragraph> <paragraph num="(2)"> <text>Informing the participant of abnormal results; and</text> </paragraph> <paragraph num="(3)"> <text>Monitoring results and improvements in patient’s ability to self-manage chronic conditions.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Medical interventions by a physician, nurse practitioner, or physician assistant based on abnormal results shall be reimbursed according to COMAR 10.09.02.07.</text> </paragraph> <paragraph num="E."> <text>A home health agency shall:</text> <paragraph num="(1)"> <text>Have an order by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner who has examined the patient and with whom the patient has an established, documented and ongoing relationship;</text> </paragraph> <paragraph num="(2)"> <text>Report abnormal measurements to the participant and to the ordering provider; and</text> </paragraph> <paragraph num="(3)"> <text>Send the ordering provider a weekly summary of monitoring results, including improvement in patient’s ability to self-manage chronic conditions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations."> <paragraph num="A."> <text>Remote patient monitoring services are only covered for participants who meet the eligibility criteria specified in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Program does not cover:</text> <paragraph num="(1)"> <text>Remote patient monitoring equipment;</text> </paragraph> <paragraph num="(2)"> <text>Upgrades to remote patient monitoring equipment;</text> </paragraph> <paragraph num="(3)"> <text>The internet connections necessary to transmit the results of remote patient monitoring services to the provider’s offices; or</text> </paragraph> <paragraph num="(4)"> <text>More than:</text> <paragraph num="(a)"> <text>2 months of remote patient monitoring services per episode; and</text> </paragraph> <paragraph num="(b)"> <text>Two episodes per year per participant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Home health agencies may only be reimbursed for remote patient monitoring when the service is ordered by a physician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Preauthorization Requirements."> <text>The Department may preauthorize services when the provider submits to the Department adequate documentation demonstrating the:</text> <paragraph num="A."> <text>Participant’s condition meets the criteria listed in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="B."> <text>Participant has not already been preauthorized for two episodes during the past rolling calendar year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Methodology."> <paragraph num="A."> <text>After providing the services outlined in Regulation .06 of this chapter, the remote patient monitoring provider shall submit the request for payment using the format designated by the Department.</text> </paragraph> <paragraph num="B."> <text>Home health agencies shall:</text> <paragraph num="(1)"> <text>Bill on a UB04; and</text> </paragraph> <paragraph num="(2)"> <text>Be paid a monthly rate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physicians, nurse practitioners, and physician assistants who provide remote patient monitoring shall:</text> <paragraph num="(1)"> <text>Bill using a CMS 1500 or an 837P; and</text> </paragraph> <paragraph num="(2)"> <text>Be paid a monthly rate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Professionals following up on abnormal results from remote patient monitoring shall be paid the lesser of:</text> <paragraph num="(1)"> <text>Provider’s customary charge unless the service is free to individuals not covered by Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>The Department’s professional fee schedule as found in COMAR 10.09.02.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement."> <text>Recovery and reimbursement shall be in accordance with COMAR 10.09.36.07.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <text>Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36.08.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Appeal Procedures."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so in accordance with COMAR 10.09.36.09.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation."> <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-103(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 2018 (44:26 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective July 24, 2023 (50:14 Md. R. 593)</annotation> </annotations> </chapter> </subtitle> <subtitle num="10" heading="Laboratories"> <chapter num="01" heading="General"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The people of Maryland are entitled to the highest level of competency, reliability, and accuracy that reasonably may be expected from a medical laboratory or crime laboratory. It is the intent of this subtitle to protect the public and individual health by requiring a medical laboratory or crime laboratory to employ qualified personnel and to operate under reliable procedures, effective quality control and quality assurance programs, and qualified supervision.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This subtitle contains the standards and requirements that a medical laboratory shall meet to:</text> <paragraph num="(1)"> <text>Obtain and retain a license to offer to perform or perform tests on human specimens; and</text> </paragraph> <paragraph num="(2)"> <text>Certify chemists and analysts in crime laboratories to perform approved testing procedures for controlled dangerous substances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This subtitle does not apply to:</text> <paragraph num="(1)"> <text>A research facility that tests human specimens and does not:</text> <paragraph num="(a)"> <text>Report any patient-specific test results for use in connection with the diagnosis and control of human disease or the assessment of the health, nutritional, or medical condition or job-related alcohol and controlled dangerous substances evaluation of individual patients or clients, or</text> </paragraph> <paragraph num="(b)"> <text>Provide test results to the patient, the patient's family, or a health care provider;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A medical laboratory operated by the federal government, unless the laboratory or tissue bank is directed by a federal agency to meet the requirements of this subtitle; and</text> </paragraph> <paragraph num="(3)"> <text>A crime laboratory operated by the federal government.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Accuracy or Accurate.</text> <paragraph num="(a)"> <text>“Accuracy” or “accurate” means the degree of agreement between the determination of a quantity and its true value.</text> </paragraph> <paragraph num="(b)"> <text>“Accuracy” or “accurate” includes the quality of a test result as it relates to the analytic phase of the testing process when the test result:</text> <paragraph num="(i)"> <text>Conforms exactly to a standard; or</text> </paragraph> <paragraph num="(ii)"> <text>Deviates only within established limits from a standard.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Alternative sanction” means a directed plan of correction or a limitation placed on testing.</text> </paragraph> <paragraph num="(3)"> <text>“Analyte” means a substance or constituent for which a laboratory conducts testing.</text> </paragraph> <paragraph num="(4)"> <text>“Analytical system” means a test system's methods, procedures, instruments, equipment, kits, reagents, and supporting materials used to detect or measure an analyte or perform a test.</text> </paragraph> <paragraph num="(5)"> <text>Authorized Person.</text> <paragraph num="(a)"> <text>“Authorized person” means an individual allowed to request a laboratory test.</text> </paragraph> <paragraph num="(b)"> <text>“Authorized person” is limited to those individuals identified under COMAR 10.10.06.02.</text> </paragraph> </paragraph> <paragraph num="(5-1)"> <text>“Buccal cavity” means the vestibule of the mouth, specifically the area lying between the teeth and cheeks.</text> </paragraph> <paragraph num="(5-2)"> <text>“Buccal swab” means a specialized applicator with a sponge, cotton, or Dacron tip, used to collect epithelial cells for DNA testing by rubbing the applicator tip on the inside of the cheek in the buccal cavity.</text> </paragraph> <paragraph num="(6)"> <text>“Calibrator” means a material having a known value or concentration that is used to standardize an analytical system.</text> </paragraph> <paragraph num="(7)"> <text>“CDC” means the Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="(8)"> <text>“Certified analyst” means an individual who:</text> <paragraph num="(a)"> <text>Meets the qualifications established under COMAR 10.10.09.01B and .02C; and</text> </paragraph> <paragraph num="(b)"> <text>Is thereby permitted to identify marijuana or marijuana products, or both, using procedures approved under COMAR 10.10.09.04.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Certified chemical analyst” means an individual who:</text> <paragraph num="(a)"> <text>Meets the qualifications established under COMAR 10.10.09.01A and .02B; and</text> </paragraph> <paragraph num="(b)"> <text>Is thereby permitted to identify marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under COMAR 10.10.09.04.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Certified chemist” means an individual who:</text> <paragraph num="(a)"> <text>Meets the qualifications established under COMAR 10.10.09.01A and .02A; and</text> </paragraph> <paragraph num="(b)"> <text>Is thereby permitted to identify any controlled dangerous substance using procedures approved under COMAR 10.10.09.04.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“CFR” means the Code of Federal Regulations.</text> </paragraph> <paragraph num="(12)"> <text>“CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 in Section 353 of the Public Health Service Act and any amendments to it (42 U.S.C. §263a).</text> </paragraph> <paragraph num="(12-1)"> <text>“CLIA waived test” means a test system, assay, or examination that the federal Department of Health and Human Services has determined meets the Clinical Laboratory Improvement Amendments (CLIA) statutory criteria as specified for waiver under the federal CLIA Amendments of 1988 in Section 353 of the Public Health Service Act of 42 U.S.C. §263a.</text> </paragraph> <paragraph num="(13)"> <text>“CMS” means the federal Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(14)"> <text>“Collection station” means a site other than a laboratory where specimens are gathered before being shipped elsewhere for laboratory testing.</text> </paragraph> <paragraph num="(15)"> <text>“Complaint investigation” means an investigation of a laboratory, including an on-site survey, initiated in response to a complaint.</text> </paragraph> <paragraph num="(16)"> <text>“Control sample” means a material, solution, or lyophilized preparation used in laboratory quality control, the concentration of which is within certain specified and known limits.</text> </paragraph> <paragraph num="(17)"> <text>“Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I through V of Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Deficiency” means a situation or finding of statutory or regulatory noncompliance.</text> </paragraph> <paragraph num="(19)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(20)"> <text>“Directed plan of correction” means a set of corrective actions stipulated by the Secretary that a laboratory shall implement to effect statutory or regulatory compliance.</text> </paragraph> <paragraph num="(21)"> <text>Discipline.</text> <paragraph num="(a)"> <text>“Discipline” means a scientific field of study in which a laboratory is licensed to offer to perform or perform tests.</text> </paragraph> <paragraph num="(b)"> <text>“Discipline” includes:</text> <paragraph num="(i)"> <text>Chemistry, including the subdisciplines of blood gas analysis, endocrinology, radioimmunoassay, routine chemistry, toxicology, and urinalysis;</text> </paragraph> <paragraph num="(ii)"> <text>Forensic toxicology, including job-related alcohol and controlled dangerous substances, limited to the detection of alcohol or a controlled dangerous substance for a non-therapeutic or non-diagnostic, job-related purpose.</text> </paragraph> <paragraph num="(iii)"> <text>Genetics, including the subdisciplines of biochemical genetics, cytogenetics, medical genetics, and molecular genetics;</text> </paragraph> <paragraph num="(iv)"> <text>Health awareness testing, which is limited to health awareness tests set forth in §B(27) of this regulation;</text> </paragraph> <paragraph num="(v)"> <text>Hematology, including the subdisciplines of coagulation testing, hemoglobinopathy screening, and routine hematology;</text> </paragraph> <paragraph num="(vi)"> <text>Immunology, including the subdisciplines of serology, immunohematology, and histocompatibility;</text> </paragraph> <paragraph num="(vii)"> <text>Microbiology, including the subdisciplines of bacteriology, mycobacteriology, mycology, parasitology, and virology;</text> </paragraph> <paragraph num="(viii)"> <text>Molecular biology, including nucleic acid probes; nucleic acid target, probe, and signal amplifications; recombinant nucleic acid techniques; and other techniques of applied molecular genetics other than cytogenetics used in connection with the diagnosis and control of human disease or the assessment of human health; and</text> </paragraph> <paragraph num="(ix)"> <text>Pathology, including the subdisciplines of gynecologic cytology, dermatopathology, and histopathology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Examinee” means an individual:</text> <paragraph num="(a)"> <text>Whose specimen is collected or tested by a laboratory; or</text> </paragraph> <paragraph num="(b)"> <text>Who is subject to a proficiency test in gynecologic cytology.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Excepted laboratory” means a medical laboratory that offers to perform or performs tests limited to one or more excepted tests.</text> </paragraph> <paragraph num="(24)"> <text>“Excepted test” means a medical laboratory test that is a CLIA waived test.</text> </paragraph> <paragraph num="(25)"> <text>“Exfoliative” means falling off in scales or layers.</text> </paragraph> <paragraph num="(26)"> <text>General Supervisor.</text> <paragraph num="(a)"> <text>“General supervisor” means a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than an excepted laboratory.</text> </paragraph> <paragraph num="(b)"> <text>“General supervisor” includes an individual who qualified as a supervisory technologist under previous State regulations.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“HDL-C” means high density lipoprotein cholesterol.</text> </paragraph> <paragraph num="(28)"> <text>Health Awareness Test.</text> <paragraph num="(a)"> <text>“Health awareness test” means a test approved by the Secretary to be performed at a temporary or mobile laboratory, such as a health fair in a shopping mall.</text> </paragraph> <paragraph num="(b)"> <text>“Health awareness test” is limited to tests that:</text> <paragraph num="(i)"> <text>Are performed solely for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions;</text> </paragraph> <paragraph num="(ii)"> <text>Are performed on a CLIA waived testing device; and</text> </paragraph> <paragraph num="(iii)"> <text>Measure glucose, lipids, or other clinical values which the Secretary has concluded are in the interest of public health to be measured at a health awareness event.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Immediate jeopardy” means a deficiency that poses immediate danger to public health or safety and requires the Secretary to take immediate action to remove the jeopardy.</text> </paragraph> <paragraph num="(30)"> <text>“Immediate precursor” means a substance that the Department has found to be, and by regulation designates as being, the principal compound commonly used or produced primarily for use and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled dangerous substance, the control of which is necessary to prevent, curtail, or limit that manufacture.</text> </paragraph> <paragraph num="(31)"> <text>“Laboratory” means a medical laboratory.</text> </paragraph> <paragraph num="(32)"> <text>“Letter of exception” means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform one or more excepted tests.</text> </paragraph> <paragraph num="(33)"> <text>“Letter of exception—limited testing for rare diseases” means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform testing limited to one or more rare disease tests.</text> </paragraph> <paragraph num="(34)"> <text>“License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to:</text> <paragraph num="(a)"> <text>Offer to perform or perform medical laboratory tests or examinations in this State;</text> </paragraph> <paragraph num="(b)"> <text>Offer to perform or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or</text> </paragraph> <paragraph num="(c)"> <text>Represent or service in this State a medical laboratory regardless of the laboratory's location.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Licensed laboratory” means a laboratory operating under a license issued by the Secretary.</text> </paragraph> <paragraph num="(36)"> <text>“Licensee” means a person who holds a license under this chapter to operate a laboratory.</text> </paragraph> <paragraph num="(37)"> <text>“Limited public health testing” means testing limited to a combination of 15 or fewer excepted tests performed by a nonprofit organization or a State, county, or local health department.</text> </paragraph> <paragraph num="(38)"> <text>“Marginal proficiency testing performance” means failure to attain the minimum satisfactory score for two of three consecutive proficiency testing events.</text> </paragraph> <paragraph num="(39)"> <text>Medical Laboratory.</text> <paragraph num="(a)"> <text>“Medical laboratory” means a facility, entity, or site that offers to perform or performs tests in connection with:</text> <paragraph num="(i)"> <text>The diagnosis and control of human disease;</text> </paragraph> <paragraph num="(ii)"> <text>The assessment of human health, nutrition, or medical conditions; or</text> </paragraph> <paragraph num="(iii)"> <text>Job-related testing.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Medical laboratory” includes but is not limited to a:</text> <paragraph num="(i)"> <text>Physician office laboratory;</text> </paragraph> <paragraph num="(ii)"> <text>Point-of-care laboratory;</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory owned or operated by the State, a county, or a municipal health department;</text> </paragraph> <paragraph num="(iv)"> <text>Not-for-profit laboratory;</text> </paragraph> <paragraph num="(v)"> <text>Hospital laboratory; and</text> </paragraph> <paragraph num="(vi)"> <text>Commercial laboratory.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(40)"> <text>Method Verification.</text> <paragraph num="(a)"> <text>“Method verification” means evaluation of an analytical system by assessment of each analytical system component, including instrument, test strip, cartridge, card, and kit reagent.</text> </paragraph> <paragraph num="(b)"> <text>“Method verification” includes but is not limited to the determination of:</text> <paragraph num="(i)"> <text>An analytical system's reportable range;</text> </paragraph> <paragraph num="(ii)"> <text>Accuracy; and</text> </paragraph> <paragraph num="(iii)"> <text>Within-run and run-to-run precision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(41)"> <text>“Mobile laboratory” means a laboratory located in a moveable vehicle, such as a truck, trailer, van, or ambulance.</text> </paragraph> <paragraph num="(42)"> <text>“Multi-site permit” means a permit available to the State, a county, or a municipal health department authorizing the operation of limited public health testing at more than one mobile or permanent laboratory.</text> </paragraph> <paragraph num="(43)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health, formerly the Licensing and Certification Administration (LCA).</text> </paragraph> <paragraph num="(44)"> <text>“Operator of an analytical system” means an individual who applies a test specimen or control sample to an analytical system and performs the necessary operative steps to isolate or identify an infectious agent or measure an analyte.</text> </paragraph> <paragraph num="(45)"> <text>“Owner” means a person who possesses a financial interest in a laboratory.</text> </paragraph> <paragraph num="(46)"> <text>“Patient of the practice” means an individual who accepts referral to or is seen or otherwise examined by a member or members of a practice of medicine.</text> </paragraph> <paragraph num="(47)"> <text>Permit.</text> <paragraph num="(a)"> <text>“Permit” means a license issued by the Secretary authorizing a person to operate a medical laboratory conducting one or more tests that are not excepted tests.</text> </paragraph> <paragraph num="(b)"> <text>“Permit” includes a:</text> <paragraph num="(i)"> <text>Provisional permit; and</text> </paragraph> <paragraph num="(ii)"> <text>Temporary permit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(48)"> <text>“Permitted laboratory” means a licensed laboratory operating under a permit.</text> </paragraph> <paragraph num="(49)"> <text>“Phlebotomist” means an individual who procures a blood specimen by venipuncture, arterial puncture, or capillary sampling.</text> </paragraph> <paragraph num="(50)"> <text>“Physician” means a doctor of medicine or a doctor of osteopathy licensed by the Maryland State Board of Physicians and a doctor of podiatric medicine licensed by the Maryland State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(51)"> <text>“Physician of a practice” means a physician employed, salaried, or otherwise engaged to operate or function as a member in a medical practice, even if the physician does not have an ownership interest in the practice or the practice's laboratory.</text> </paragraph> <paragraph num="(52)"> <text>“Physician office laboratory (POL)” means a medical laboratory operated by a single practice of medicine, individually or collectively by one or more physicians, that is used solely as an adjunct to the care of patients of the practice.</text> </paragraph> <paragraph num="(53)"> <text>“Point-of-care laboratory (POCL)” means a laboratory operated as part of, or in association with, a medical care facility, such as a hospital, nursing home, community health center, health maintenance organization, county or municipal health department, or a pharmacy.</text> </paragraph> <paragraph num="(54)"> <text>“Practice” means:</text> <paragraph num="(a)"> <text>An individual physician licensed to practice medicine in the State; or</text> </paragraph> <paragraph num="(b)"> <text>A medical partnership, professional association, professional service corporation, or medical corporation of two or more physicians licensed to practice medicine in the State and sharing facilities, personnel, income, or business expenses.</text> </paragraph> </paragraph> <paragraph num="(55)"> <text>“Precision” means the agreement of results among themselves when a specimen or sample is tested multiple times.</text> </paragraph> <paragraph num="(56)"> <text>“Pre-field evaluation” means the assessment of an analytical system before it may be used in a mobile or temporary laboratory.</text> </paragraph> <paragraph num="(57)"> <text>“Primary standard” means a comprehensive general standard or set of standards that:</text> <paragraph num="(a)"> <text>A laboratory must meet to obtain or retain a license to operate; or</text> </paragraph> <paragraph num="(b)"> <text>An individual must meet in order to examine gynecologic cytology specimens.</text> </paragraph> </paragraph> <paragraph num="(58)"> <text>“Principal sanction” means the denial, suspension, or revocation of a license.</text> </paragraph> <paragraph num="(59)"> <text>“Proficiency testing (PT)” means evaluation of an individual's ability to perform laboratory procedures or tests within the PT program's defined limits of accuracy through analysis of unknown samples distributed at periodic intervals by an external source.</text> </paragraph> <paragraph num="(60)"> <text>“Public health laboratory” means a public, nonprofit laboratory solely owned and operated by or for the State, a county, or a municipal health department located in the State.</text> </paragraph> <paragraph num="(61)"> <text>Quality Assurance.</text> <paragraph num="(a)"> <text>“Quality assurance” means a system of established written policies and procedures designed to monitor, review, evaluate, and improve the ongoing and overall quality of the preanalytic, analytic, and postanalytic aspects of laboratory testing.</text> </paragraph> <paragraph num="(b)"> <text>“Quality assurance” includes but is not limited to practices involving:</text> <paragraph num="(i)"> <text>Patient preparation;</text> </paragraph> <paragraph num="(ii)"> <text>Specimen collection, labeling, processing, and transport;</text> </paragraph> <paragraph num="(iii)"> <text>Quality control strategies, practices, and results;</text> </paragraph> <paragraph num="(iv)"> <text>Record keeping;</text> </paragraph> <paragraph num="(v)"> <text>Personnel training and competency;</text> </paragraph> <paragraph num="(vi)"> <text>Continuing education;</text> </paragraph> <paragraph num="(vii)"> <text>Proficiency testing;</text> </paragraph> <paragraph num="(viii)"> <text>Remedial and corrective actions; and</text> </paragraph> <paragraph num="(ix)"> <text>Analytical system evaluation, validation, and verification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(62)"> <text>Quality Control.</text> <paragraph num="(a)"> <text>“Quality control” means established written policies and procedures designed to ensure reliable laboratory testing by monitoring, reviewing, and evaluating the analytic aspects of laboratory testing.</text> </paragraph> <paragraph num="(b)"> <text>“Quality control” includes but is not limited to policies and procedures that detect, monitor, review, and evaluate the:</text> <paragraph num="(i)"> <text>Accuracy and precision of the analytic phase of a testing process;</text> </paragraph> <paragraph num="(ii)"> <text>Changes in the chemical, electronic, optical, or mechanical components of an analytical system;</text> </paragraph> <paragraph num="(iii)"> <text>Deterioration of reagents, materials, or supplies used in a testing process; and</text> </paragraph> <paragraph num="(iv)"> <text>Personnel practices during a testing process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Quality control test” means an examination performed on an external test sample that:</text> <paragraph num="(a)"> <text>Is not part of the analytical system;</text> </paragraph> <paragraph num="(b)"> <text>Contains a known quantity of the analyte being tested;</text> </paragraph> <paragraph num="(c)"> <text>Is similar in its physical characteristics and constituents to patient specimens tested by the system; and</text> </paragraph> <paragraph num="(d)"> <text>Reacts with all system components in the same way as a patient specimen.</text> </paragraph> </paragraph> <paragraph num="(64)"> <text>“Rare disease” means:</text> <paragraph num="(a)"> <text>A disabling, chronically debilitating, or life-threatening disease or condition that has fewer than 200,000 affected individuals in the United States, which is equivalent to:</text> <paragraph num="(i)"> <text>A prevalence of fewer than one individual per 2,000 individuals in the population; or</text> </paragraph> <paragraph num="(ii)"> <text>An incidence of fewer than one affected individual per 10,000 individuals in the population;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A disabling or life-threatening disease or condition that is listed as a rare disease by the National Institutes of Health Office of Rare Diseases; or</text> </paragraph> <paragraph num="(c)"> <text>A disabling or life-threatening disease or condition in which more than 200,000 individuals are affected if:</text> <paragraph num="(i)"> <text>A subpopulation of the disease or condition is equal to the prevalence standard for a rare disease in §B(64)(a) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>The incidence of the disease or condition is fewer than five affected individuals per 10,000 in a defined community.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(65)"> <text>Rare Disease Test.</text> <paragraph num="(a)"> <text>“Rare disease test” means a test that is:</text> <paragraph num="(i)"> <text>Performed on a specimen obtained from an individual in order to determine or evaluate whether the individual has a rare disease or condition;</text> </paragraph> <paragraph num="(ii)"> <text>Based on a single method using one sample of a specimen to produce the test result; and</text> </paragraph> <paragraph num="(iii)"> <text>Not routinely offered or performed by a medical laboratory permitted by the Department.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Rare disease test” includes a test with multiple clinical or health evaluation uses such as:</text> <paragraph num="(i)"> <text>Newborn screening;</text> </paragraph> <paragraph num="(ii)"> <text>Carrier screening;</text> </paragraph> <paragraph num="(iii)"> <text>Predictive testing;</text> </paragraph> <paragraph num="(iv)"> <text>Disease diagnosis; or</text> </paragraph> <paragraph num="(v)"> <text>Disease prognosis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(66)"> <text>“Reliable” means that the quality of a test result meets the quality standards for the preanalytic, analytic, and postanalytic phases of the testing process as set forth in COMAR 10.10.06.</text> </paragraph> <paragraph num="(67)"> <text>“Remeasurement” means repeating the measurement of an analyte.</text> </paragraph> <paragraph num="(68)"> <text>“Sample” means a substance, constituent, or material intended for use in quality control, proficiency testing, or another aspect of a laboratory's quality assurance program.</text> </paragraph> <paragraph num="(69)"> <text>Sanction.</text> <paragraph num="(a)"> <text>“Sanction” means an action that the Secretary may take to effect statutory or regulatory compliance.</text> </paragraph> <paragraph num="(b)"> <text>“Sanction” includes a principal sanction and an alternative sanction.</text> </paragraph> </paragraph> <paragraph num="(70)"> <text>Secretary.</text> <paragraph num="(a)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(b)"> <text>“Secretary” includes the Office of Health Care Quality as a designee.</text> </paragraph> </paragraph> <paragraph num="(71)"> <text>“SOPM” means a standard operating procedure manual.</text> </paragraph> <paragraph num="(72)"> <text>“Specialty” means a scientific field of study within a laboratory subdiscipline, such as compatibility testing within the subdiscipline of immunohematology.</text> </paragraph> <paragraph num="(73)"> <text>“Specimen” means material collected from the human body and intended for laboratory testing.</text> </paragraph> <paragraph num="(74)"> <text>“Standard” means one or more specific technical, procedural, fiscal, or other requirements that a laboratory or individual must meet to comply with this chapter.</text> </paragraph> <paragraph num="(75)"> <text>“Subdiscipline” means a scientific field of study within a laboratory discipline, such as bacteriology within the discipline of microbiology and dermatopathology within the discipline of pathology.</text> </paragraph> <paragraph num="(76)"> <text>Survey.</text> <paragraph num="(a)"> <text>“Survey” means an on-site visit to a laboratory by one or more employees of the OHCQ to carry out or oversee the regulation of medical laboratories.</text> </paragraph> <paragraph num="(b)"> <text>“Survey” includes but is not limited to:</text> <paragraph num="(i)"> <text>Inspection;</text> </paragraph> <paragraph num="(ii)"> <text>Follow-up inspection;</text> </paragraph> <paragraph num="(iii)"> <text>Complaint investigation; and</text> </paragraph> <paragraph num="(iv)"> <text>On-site monitoring.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(77)"> <text>System Check.</text> <paragraph num="(a)"> <text>“System check” means a device that verifies all or part of the chemical, electronic, optical, or mechanical components or constituents of a test system to determine if the test system is functioning properly.</text> </paragraph> <paragraph num="(b)"> <text>“System check” includes chemical, electronic, optical, or mechanical devices, such as a card, tube, or strip that simulates a properly functioning single-use test device.</text> </paragraph> <paragraph num="(c)"> <text>“System check” does not include a quality control test sample or patient specimen.</text> </paragraph> </paragraph> <paragraph num="(78)"> <text>“Technical supervisor” means an individual who is qualified to direct medical laboratory testing in at least one laboratory discipline.</text> </paragraph> <paragraph num="(79)"> <text>“Technician” means an individual who has at least 1 year of experience in a licensed medical laboratory, other than an excepted laboratory, and who has earned:</text> <paragraph num="(a)"> <text>An associate degree in a laboratory science or medical laboratory technology from an accredited college or university; or</text> </paragraph> <paragraph num="(b)"> <text>60 semester hours of academic credit, including 24 semester credit hours of science that include:</text> <paragraph num="(i)"> <text>6 semester hours of chemistry, and</text> </paragraph> <paragraph num="(ii)"> <text>6 semester hours of biology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(80)"> <text>“Technologist” means an individual who:</text> <paragraph num="(a)"> <text>Possesses a bachelor's degree in a chemical, physical, biological, or clinical laboratory science or in medical technology from an accredited college or university and has at least 1 year of full-time laboratory experience in the discipline in which the individual performs tests;</text> </paragraph> <paragraph num="(b)"> <text>Received a passing score in the United States Department of Health and Human Services proficiency examination for clinical laboratory technologists; or</text> </paragraph> <paragraph num="(c)"> <text>Meets the technologist qualifications set forth in 42 CFR §493.1491, which is incorporated by reference in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(81)"> <text>“Temporary laboratory” means a medical laboratory located at a temporary testing site, such as a health fair or shopping mall, for fewer than 30 days in 12 consecutive months.</text> </paragraph> <paragraph num="(82)"> <text>“Test” means a medical laboratory examination, analysis, procedure, or preanalytic, analytic, or postanalytic phase of a testing process.</text> </paragraph> <paragraph num="(83)"> <text>“Testing event” means an occasion when a health awareness test is offered or performed on a specified date at a temporary laboratory.</text> </paragraph> <paragraph num="(84)"> <text>“Testing personnel” means an individual or individuals employed or otherwise engaged by a laboratory to perform medical laboratory tests.</text> </paragraph> <paragraph num="(85)"> <text>“Total number of tests” means all tests performed by a laboratory in all disciplines in the previous calendar year.</text> </paragraph> <paragraph num="(86)"> <text>“Unsatisfactory proficiency testing performance” means failure to attain the minimum satisfactory score for three of four consecutive proficiency testing events.</text> </paragraph> <paragraph num="(87)"> <text>“Test System” means the instructions, instrumentation, equipment, and reagents necessary to perform an assay or examination that generates test results.</text> </paragraph> <paragraph num="(88)"> <text>“Validity check” means a procedural, testing process, or analytical verification of proper performance of one or more analytical steps performed by the test system operator, built into a test system, and carried out by a test system to detect environmental damage or interfering substances that may have affected the device or the results of the testing process.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this subtitle, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>29 CFR §1910.1030, as amended.</text> </paragraph> <paragraph num="(2)"> <text>29 CFR §1910.1450, as amended.</text> </paragraph> <paragraph num="(3)"> <text>42 CFR §§493.801—493.959, as amended.</text> </paragraph> <paragraph num="(4)"> <text>42 CFR §§493.1100—493.1299, as amended.</text> </paragraph> <paragraph num="(5)"> <text>42 CFR §§493.1405—493.1495, as amended.</text> </paragraph> <paragraph num="(6)"> <text>49 CFR §40.87, as amended.</text> </paragraph> <paragraph num="(7)"> <text>Forensic Chemists and Analysts Training and Procedure Manual (Maryland Department of Health, 1992).</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1969</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 2, 1977 (4:5 Md. R. 372)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 10, 1986 (13:3 Md. R. 271)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03N amended effective December 28, 1987 (14:26 Md. R. 2747)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 28, 1987 (14:26 Md. R. 2747)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 30, 1989 (16:21 Md. R. 2261)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 29, 1990 (17:21 Md. R. 2529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05, .10—.12, .15, and .18 amended and new Regulation .20 adopted as an emergency provision effective May 1, 1992 (19:10 Md. R. 926) Regulation .05A amended effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and new Regulation .11 adopted effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 repealed and new Regulation .14 adopted as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 repealed and new Regulation .15 adopted effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18C amended effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 adopted effective October 1, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 23, 2002 (29:25 Md. R. 1982); June 1, 2009 (36:11 Md. R. 787); January 13, 2011 (38:1 Md. R. 11); April 16, 2012 (39:7 Md. R. 492); April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective June 1, 2009 (36:11 Md. R. Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 23, 2002 (29:25 Md. R. 1982); June 1, 2009 (36:11 Md. R. 787); January 13, 2011 (38:1 Md. R. 11); April 16, 2012 (39:7 Md. R. 492); April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> </annotations> </chapter> <chapter num="02" heading="Medical Laboratories — General"> <regulation prefix="Regulation" num=".01" heading="Responsibilities of the Department."> <paragraph num="A."> <text>The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license.</text> </paragraph> <paragraph num="B."> <text>Surveys. The OHCQ shall:</text> <paragraph num="(1)"> <text>Conduct or oversee an announced or unannounced survey of a laboratory at any time during its hours of operation to assess compliance with applicable sections of Health-General Article, Title 17, Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Examine, as part of a survey, a laboratory's facilities, equipment, quality assurance records and procedures, operating procedures, personnel and personnel records, proficiency testing, patient reports, and other records and files pertinent and subject to this subtitle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Issuance of Licensing Documents. The OHCQ shall:</text> <paragraph num="(1)"> <text>License a person to operate a laboratory by issuing a letter of exception or permit when the laboratory is in compliance with the applicable standards set forth in this subtitle;</text> </paragraph> <paragraph num="(2)"> <text>Issue a license that includes the:</text> <paragraph num="(a)"> <text>Name of the laboratory;</text> </paragraph> <paragraph num="(b)"> <text>Name of the licensee or laboratory director; and</text> </paragraph> <paragraph num="(c)"> <text>Name of the laboratory owner.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Issue a license that designates:</text> <paragraph num="(a)"> <text>The classes of services, that is, disciplines, provided;</text> </paragraph> <paragraph num="(b)"> <text>The tests or examinations offered; or</text> </paragraph> <paragraph num="(c)"> <text>Both §C(3)(a) and (b) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Administration and Information Management. The OHCQ shall:</text> <paragraph num="(1)"> <text>Maintain a list of licensed laboratories;</text> </paragraph> <paragraph num="(2)"> <text>Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary;</text> </paragraph> <paragraph num="(3)"> <text>Monitor the proficiency testing performance of a laboratory required to participate in proficiency testing; and</text> </paragraph> <paragraph num="(4)"> <text>For tests that are not CLIA waived, impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a laboratory under the appropriate provisions of this subtitle.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Recommending Excepted Test Status.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Accredited Laboratory and Accrediting Organization."> <paragraph num="A."> <text>Accredited Laboratory — Determination. The Secretary shall accept as meeting the survey requirements of this chapter a laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the laboratory's accrediting organization are equivalent to those under this subtitle.</text> </paragraph> <paragraph num="B."> <text>Accredited Laboratory — Requirements. In addition to meeting the requirements for its certificate of accreditation, as set forth by its accrediting organization, an accredited laboratory shall:</text> <paragraph num="(1)"> <text>Obtain and maintain a valid license issued by the Secretary; and</text> </paragraph> <paragraph num="(2)"> <text>Be subject to survey by the OHCQ for the purpose of investigating complaints or validating findings of the laboratory's accrediting organization.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Accrediting Organization.</text> <paragraph num="(1)"> <text>A private, nonprofit laboratory accrediting organization may inspect and accredit laboratories in the State for the purpose of Maryland State licensure only after applying for and receiving approval of the OHCQ.</text> </paragraph> <paragraph num="(2)"> <text>The OHCQ shall base approval of a laboratory accrediting organization on a review of that organization, when the review includes but is not limited to an evaluation of:</text> <paragraph num="(a)"> <text>Documentation of current accrediting status issued by CMS and of compliance with CMS reporting requirements;</text> </paragraph> <paragraph num="(b)"> <text>Accreditation policies and standards;</text> </paragraph> <paragraph num="(c)"> <text>Copies of survey forms and guidelines;</text> </paragraph> <paragraph num="(d)"> <text>Surveying and deficiency writing policies;</text> </paragraph> <paragraph num="(e)"> <text>Surveyor qualifications;</text> </paragraph> <paragraph num="(f)"> <text>Complaint investigation policies;</text> </paragraph> <paragraph num="(g)"> <text>Proficiency test monitoring policies;</text> </paragraph> <paragraph num="(h)"> <text>Procedures the accrediting organization will follow when notifying the OHCQ that the organization:</text> <paragraph num="(i)"> <text>Is denying, withdrawing, suspending, or revoking a laboratory's accreditation;</text> </paragraph> <paragraph num="(ii)"> <text>Finds serious patient jeopardy or identifies a hazard to public safety;</text> </paragraph> <paragraph num="(iii)"> <text>Accredits a new laboratory;</text> </paragraph> <paragraph num="(iv)"> <text>Imposes an adverse or corrective action on a laboratory; or</text> </paragraph> <paragraph num="(v)"> <text>Is initiating a complaint investigation; and</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>The accrediting organization's compliance with the requirements of §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to requirements set forth elsewhere in this regulation, an accrediting organization shall:</text> <paragraph num="(a)"> <text>Provide to the OHCQ:</text> <paragraph num="(i)"> <text>Annually, an updated list containing the names, addresses, and accreditation expiration dates of all accredited laboratories in the State;</text> </paragraph> <paragraph num="(ii)"> <text>Within 30 days after conducting a survey, a certified written or electronic copy of each survey report covering each laboratory applying for or maintaining accreditation in the State;</text> </paragraph> <paragraph num="(iii)"> <text>Written notice of any proposed change to requirements for laboratory accreditation, at least 30 days before the effective date of the change;</text> </paragraph> <paragraph num="(iv)"> <text>Within 30 days after a laboratory's certificate of accreditation expires, written or electronic notice when the laboratory does not renew its certificate; and</text> </paragraph> <paragraph num="(v)"> <text>Within 24 hours after taking an action, telephonic or electronic notice whenever an accredited laboratory's certificate of accreditation is limited, suspended, revoked, or surrendered;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evaluate compliance, when applicable, with State regulations pertaining to:</text> <paragraph num="(i)"> <text>Cholesterol testing;</text> </paragraph> <paragraph num="(ii)"> <text>Gynecological cytology;</text> </paragraph> <paragraph num="(iii)"> <text>Dermatopathology;</text> </paragraph> <paragraph num="(iv)"> <text>Forensic toxicology;</text> </paragraph> <paragraph num="(v)"> <text>Laboratory reporting of test results covering contagious disease, blood lead, cancer, and other tests as required by law or regulation;</text> </paragraph> <paragraph num="(vi)"> <text>Proficiency testing;</text> </paragraph> <paragraph num="(vii)"> <text>Special medical waste disposal; and</text> </paragraph> <paragraph num="(viii)"> <text>Testing performed at a temporary or mobile laboratory;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Evaluate compliance with State regulations by:</text> <paragraph num="(i)"> <text>Employing a checklist provided by the Department;</text> </paragraph> <paragraph num="(ii)"> <text>Incorporating an evaluation of compliance with State regulatory requirements into its own survey process; or</text> </paragraph> <paragraph num="(iii)"> <text>Demonstrating that its existing survey process adequately evaluates compliance with State regulations; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>On request, provide to OHCQ a copy of:</text> <paragraph num="(i)"> <text>A complaint investigation;</text> </paragraph> <paragraph num="(ii)"> <text>Surveyor qualifications;</text> </paragraph> <paragraph num="(iii)"> <text>A change in a laboratory's disciplines, subdisciplines, or specialties; and</text> </paragraph> <paragraph num="(iv)"> <text>Other information the Secretary may require relating to approval of a laboratory accrediting organization.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Surveys."> <paragraph num="A."> <text>General.</text> <paragraph num="(1)"> <text>A licensee shall allow an on-site survey by the OHCQ or, when applicable, by the laboratory's approved accrediting organization, at any time during the laboratory's normal hours of operation, to evaluate the laboratory's compliance with the applicable requirements, conditions, and standards of this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>A survey may include but is not limited to:</text> <paragraph num="(a)"> <text>Observation and examination of laboratory facilities;</text> </paragraph> <paragraph num="(b)"> <text>Equipment;</text> </paragraph> <paragraph num="(c)"> <text>Quality assurance and quality control program records;</text> </paragraph> <paragraph num="(d)"> <text>Operating procedures;</text> </paragraph> <paragraph num="(e)"> <text>Personnel;</text> </paragraph> <paragraph num="(f)"> <text>Personnel records;</text> </paragraph> <paragraph num="(g)"> <text>Proficiency testing;</text> </paragraph> <paragraph num="(h)"> <text>Patient reports; and</text> </paragraph> <paragraph num="(i)"> <text>Other records and files pertinent to this subtitle.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Laboratory employees shall make data and records accessible within a reasonable time during the on-site survey.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Excepted Laboratory. A licensee operating a laboratory under a letter of exception, other than a mobile or temporary laboratory, is:</text> <paragraph num="(1)"> <text>Not subject to routine, on-site surveys;</text> </paragraph> <paragraph num="(2)"> <text>Subject to surveys resulting from complaints or periodic validations, or both, conducted by the Secretary or CMS, or both, to determine regulatory compliance; and</text> </paragraph> <paragraph num="(3)"> <text>Required to make available, pursuant to a survey, records the Secretary may reasonably require to determine regulatory compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Permitted Laboratory. A licensee operating a laboratory under a permit shall:</text> <paragraph num="(1)"> <text>Be subject to routine surveys conducted by OHCQ;</text> </paragraph> <paragraph num="(2)"> <text>Undergo a routine annual survey for 2 consecutive years after the laboratory:</text> <paragraph num="(a)"> <text>Begins operating;</text> </paragraph> <paragraph num="(b)"> <text>Undergoes a change in ownership;</text> </paragraph> <paragraph num="(c)"> <text>Fails to complete or submit to the Department an acceptable quality assurance self-assessment on forms provided by the OHCQ; or</text> </paragraph> <paragraph num="(d)"> <text>Has imposed on it a principal or alternative sanction; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Undergo a routine biennial survey when the laboratory:</text> <paragraph num="(a)"> <text>Does not fall under one of the categories set forth in §C(2) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Completes and submits to the OHCQ an acceptable quality assurance self-assessment on forms provided by the OHCQ on the years when the OHCQ does not conduct an on-site survey, except as provided in §D of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Accredited Laboratory. An accredited laboratory:</text> <paragraph num="(1)"> <text>Undergoing routine on-site surveys conducted by an accrediting organization approved by the Secretary, except as provided in §D(2) and (3) of this regulation, is not subject to routine surveys conducted by the OHCQ;</text> </paragraph> <paragraph num="(2)"> <text>Is subject to surveys conducted by the OHCQ to investigate a complaint or to determine regulatory compliance; and</text> </paragraph> <paragraph num="(3)"> <text>Holding a permit in the discipline of forensic toxicology, subdiscipline of job-related testing, is subject to routine surveys of the laboratory's alcohol and controlled dangerous substances testing areas conducted by the OHCQ.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Temporary or Mobile Laboratory. The OHCQ may survey each testing event site when a temporary or mobile laboratory licensee offers to perform or performs testing services.</text> </paragraph> <paragraph num="F."> <text>Excepted Laboratory — Limited Testing for Rare Diseases. A licensee operating a laboratory under a letter of exception — limited testing for rare diseases is subject to the survey requirements stated in §B of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Courts and Judicial Proceedings Article, §10-1001; Health General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E adopted effective January 21, 2002 (29:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F adopted effective August 29, 2005 (32:17 Md. R. 1438)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective July 24, 2000 (27:14 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> </annotations> </chapter> <chapter num="03" heading="Medical Laboratories — Licenses"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>Requirement.</text> <paragraph num="(1)"> <text>General. A person shall possess a license before:</text> <paragraph num="(a)"> <text>Offering to perform or performing a medical laboratory test or examination in this State;</text> </paragraph> <paragraph num="(b)"> <text>Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; or</text> </paragraph> <paragraph num="(c)"> <text>Representing or servicing in this State a laboratory regardless of the laboratory's location.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prohibited Tests. The Secretary may impose principal and alternative sanctions as set forth in COMAR 10.10.08.01A if a person offers to perform or performs a test or part of a test, including the use of a reagent, supply, procedure, technique, kit, or equipment, that:</text> <paragraph num="(a)"> <text>Does not produce accurate or reliable results as evidenced by documented, independent scientific testing and evaluation; or</text> </paragraph> <paragraph num="(b)"> <text>Lacks proof of efficacy substantiated by an independently conducted and documented scientifically based clinical trial.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Cholesterol Testing Plan for Health Departments.</text> <paragraph num="(a)"> <text>A local or county health department intending to perform cholesterol testing outside a permanently located laboratory may submit to the Secretary a cholesterol testing plan instead of applying for a cholesterol testing permit.</text> </paragraph> <paragraph num="(b)"> <text>If the submitted plan meets applicable standards under this chapter, the Secretary may waive the permit requirement for a cholesterol testing permit.</text> </paragraph> <paragraph num="(c)"> <text>If the plan does not meet the applicable standards of this chapter, the local or county health department shall apply for a permit as set forth in this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Limitation. A person may not operate a laboratory in a discipline other than what is listed on the license.</text> </paragraph> <paragraph num="C."> <text>Eligibility. A person meeting the requirements and standards of this chapter may apply for one or more of the following licenses:</text> </paragraph> <paragraph num="D."> <text>Issuance.</text> <paragraph num="(1)"> <text>Provisional Permit.</text> <paragraph num="(a)"> <text>The Secretary may issue a provisional permit before or after conducting an initial survey and pending determination of compliance with the standards in this chapter.</text> </paragraph> <paragraph num="(b)"> <text>A provisional permit is valid for not more than 180 days and may not be renewed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Letter of Exception and Permit. The Secretary may issue a letter of exception or permit that:</text> <paragraph num="(a)"> <text>Is valid for not more than 2 years from the date of issue; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Single-Site and Multi-Site Licenses.</text> <paragraph num="(a)"> <text>Except as set forth in §D(3)(b) of this regulation, a person shall obtain a separate, single-site license for each location at which a laboratory performs a test.</text> </paragraph> <paragraph num="(b)"> <text>The Secretary may issue a multi-site license to a person operating:</text> <paragraph num="(i)"> <text>A mobile laboratory using the address of its home base or main administrative office in the State;</text> </paragraph> <paragraph num="(ii)"> <text>A nonprofit laboratory or public health laboratory performing limited public health testing; and</text> </paragraph> <paragraph num="(iii)"> <text>Hospital laboratories located at the same street address or within contiguous buildings and under common direction.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local laboratory requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Letters of Exception."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>An individual directing a POL or POCL who offers to perform or performs tests limited to one or more excepted tests may obtain a letter of exception instead of a permit to offer to perform or perform those tests.</text> </paragraph> <paragraph num="(2)"> <text>An individual eligible for a letter of exception shall:</text> <paragraph num="(a)"> <text>Be qualified as a laboratory director as set forth in 42 CFR §493.1405, including:</text> <paragraph num="(i)"> <text>Being a doctor of medicine or doctor of osteopathy licensed in the State and having laboratory training or experience appropriate for the testing performed; or</text> </paragraph> <paragraph num="(ii)"> <text>Holding an earned doctoral, master's, or bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide evidence of training in the performance and interpretation of excepted tests and be licensed in the State as a:</text> <paragraph num="(i)"> <text>Nurse midwife;</text> </paragraph> <paragraph num="(ii)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(iii)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(iv)"> <text>Chiropractor;</text> </paragraph> <paragraph num="(v)"> <text>Podiatrist;</text> </paragraph> <paragraph num="(vi)"> <text>Dentist; or</text> </paragraph> <paragraph num="(vii)"> <text>Pharmacist; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Be clinical staff who:</text> <paragraph num="(i)"> <text>Meets the qualifications set forth in COMAR 10.47.01.06D;</text> </paragraph> <paragraph num="(ii)"> <text>Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and</text> </paragraph> <paragraph num="(iii)"> <text>Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A person operating a temporary medical laboratory to perform health awareness tests, regardless of testing site location, is not eligible for a letter of exception.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Excepted Tests. A POL or POCL operating under a letter of exception may perform one or more CLIA waived tests.</text> </paragraph> <paragraph num="C."> <text>Reporting Requirements for Whole Blood Lead Testing on a CLIA Waived Analyzer.</text> <paragraph num="(1)"> <text>The blood tests for lead shall:</text> <paragraph num="(a)"> <text>Be reported under this regulation in the format approved by the Maryland Department of the Environment; and</text> </paragraph> <paragraph num="(b)"> <text>Include the information required by this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The blood tests for lead to be reported shall include the following information:</text> <paragraph num="(a)"> <text>Demographic information including:</text> <paragraph num="(i)"> <text>Name, including first, last, middle initial;</text> </paragraph> <paragraph num="(ii)"> <text>Date of birth, sex, and race;</text> </paragraph> <paragraph num="(iii)"> <text>Complete home address at the time the blood specimen was drawn including house or apartment number, street, city, county or town, zip code, and state;</text> </paragraph> <paragraph num="(iv)"> <text>Telephone number; and</text> </paragraph> <paragraph num="(v)"> <text>Parent or guardian name;</text> </paragraph> <paragraph num="(vi)"> <text>Residential status, for example, whether parent or guardian owns their home or rents;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Type of specimen, either venous or capillary, and date the specimen was drawn;</text> </paragraph> <paragraph num="(c)"> <text>Clinic or practice name, address, and telephone number;</text> </paragraph> <paragraph num="(d)"> <text>Draw site name and address, if different from clinic or practice;</text> </paragraph> <paragraph num="(e)"> <text>Blood lead level in micrograms per deciliter; and</text> </paragraph> <paragraph num="(f)"> <text>Any additional information as may be required by the Maryland Department of the Environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Regulatory Requirements. An individual required to obtain a license to operate a laboratory who chooses to operate under a letter of exception shall:</text> <paragraph num="(1)"> <text>Obtain, complete, and file an application as prescribed in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with good laboratory practices that include:</text> <paragraph num="(a)"> <text>Following the manufacturer's instructions for instrument or test system operation and test performance;</text> </paragraph> <paragraph num="(b)"> <text>Having a procedure manual describing the processes for performing tests and reporting patient test results;</text> </paragraph> <paragraph num="(c)"> <text>Performing and documenting quality control procedures using applicable levels of control materials each day of testing;</text> </paragraph> <paragraph num="(d)"> <text>Performing and documenting that remedial action has been taken when problems or errors are identified;</text> </paragraph> <paragraph num="(e)"> <text>Documenting lot numbers of all quality control reagents used; and</text> </paragraph> <paragraph num="(f)"> <text>Performing and documenting test system function for instruments with internal quality controls on each day of testing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permits."> <paragraph num="A."> <text>Requirement. A person operating a medical laboratory that performs one or more tests other than excepted tests shall obtain and renew a laboratory permit as required in this chapter.</text> </paragraph> <paragraph num="B."> <text>Tests Other than Excepted Tests.</text> <paragraph num="(1)"> <text>A test other than an excepted test is one not listed in Regulation .02B of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A person holding a permit may perform both excepted tests and tests other than excepted tests.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Regulatory Requirements. A person operating a medical laboratory under a permit shall:</text> <paragraph num="(1)"> <text>Obtain, complete, and submit permit applications as prescribed in this chapter and COMAR 10.10.04;</text> </paragraph> <paragraph num="(2)"> <text>Comply with the survey requirements set forth in this subtitle;</text> </paragraph> <paragraph num="(3)"> <text>Comply with the applicable quality assurance and quality control requirements required in COMAR 10.10.06;</text> </paragraph> <paragraph num="(4)"> <text>Comply with the applicable proficiency testing requirements required in COMAR 10.10.05; and</text> </paragraph> <paragraph num="(5)"> <text>Comply with the applicable personnel requirements required in COMAR 10.10.06.15B and 10.10.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Letter of Exception and Permit — Administrative Procedures."> <paragraph num="A."> <text>Application — Filing.</text> <paragraph num="(1)"> <text>Except for a laboratory eligible for a multi-site license as set forth in Regulation .01D(3)(b) of this chapter, a person shall apply for a license for each laboratory location.</text> </paragraph> <paragraph num="(2)"> <text>A person holding a license to operate a laboratory in the discipline of chemistry or health awareness testing is not required to obtain a separate cholesterol testing permit to conduct cholesterol testing at a temporary laboratory site if the licensee complies with the requirements applicable to a temporary laboratory as set forth in this subtitle.</text> </paragraph> <paragraph num="(3)"> <text>A person shall complete and file an application for a license using forms provided by the OHCQ.</text> </paragraph> <paragraph num="(4)"> <text>A person shall complete on the application a description of laboratory services, which includes but is not limited to:</text> <paragraph num="(a)"> <text>Types of tests performed or to be performed;</text> </paragraph> <paragraph num="(b)"> <text>Total number of tests performed or to be performed annually, excluding tests for quality control and proficiency testing; and</text> </paragraph> <paragraph num="(c)"> <text>Qualifications of personnel who direct, supervise, and perform laboratory testing.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The laboratory director shall sign the application forms attesting that the information provided is accurate and that the laboratory is or will be operated in accordance with the requirements and standards required in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application — Evaluation and Billing.</text> <paragraph num="(1)"> <text>The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if an application is complete.</text> </paragraph> <paragraph num="(2)"> <text>The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the laboratory is eligible for a:</text> <paragraph num="(a)"> <text>Letter of exception;</text> </paragraph> <paragraph num="(b)"> <text>Letter of exception — limited testing for rare diseases; or</text> </paragraph> <paragraph num="(c)"> <text>Permit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Application — Denial of License. If the OHCQ determines that a laboratory is not in compliance with the requirements of this chapter and therefore cannot be issued a license, the OHCQ shall provide to the laboratory:</text> <paragraph num="(1)"> <text>A written statement of the grounds on which the denial is based; and</text> </paragraph> <paragraph num="(2)"> <text>The opportunity to:</text> <paragraph num="(a)"> <text>Amend and resubmit the application; or</text> </paragraph> <paragraph num="(b)"> <text>Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201—10-226, and Health-General Article, §§17-210 and 17-509, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notification Requirements. A licensee shall notify the OHCQ within 30 days of a change in laboratory:</text> <paragraph num="(1)"> <text>Ownership;</text> </paragraph> <paragraph num="(2)"> <text>Name;</text> </paragraph> <paragraph num="(3)"> <text>Location; or</text> </paragraph> <paragraph num="(4)"> <text>Director.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Amending a Permit. Except as prescribed in §D of this regulation, a licensee holding an unexpired permit who wishes to amend it shall:</text> <paragraph num="(1)"> <text>Submit a written request for amendment to the Secretary; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain written approval from the OHCQ before implementing the amendment.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Non-Transferability. A license is not transferable between laboratories, directors, or locations.</text> </paragraph> <paragraph num="G."> <text>Letter of Exception. A person applying for a letter of exception for a POL or POCL shall submit an initial application.</text> </paragraph> <paragraph num="H."> <text>Letter of Exception — Limited Testing for Rare Diseases. A person applying for a letter of exception—limited testing for rare diseases for a laboratory shall submit an initial application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Letter of Exception — Limited Testing for Rare Diseases."> <paragraph num="A."> <text>The Secretary may waive the permit requirements under this subtitle for a laboratory that offers to perform or performs a rare disease test if the laboratory:</text> <paragraph num="(1)"> <text>Meets the requirements of Regulations .05 and .06 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Obtains and maintains a letter of exception — limited testing for rare diseases.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility. A person operating a medical laboratory may be eligible for a letter of exception — limited testing for rare diseases if the laboratory:</text> <paragraph num="(1)"> <text>Is operated as:</text> <paragraph num="(a)"> <text>A not-for-profit entity; or</text> </paragraph> <paragraph num="(b)"> <text>Part of an accredited educational institution;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Performs not more than a total of 50 tests per year for a specific rare disease on specimens from Maryland patients;</text> </paragraph> <paragraph num="(3)"> <text>Offers to perform or performs only rare disease tests as defined in COMAR 10.10.01.03B;</text> </paragraph> <paragraph num="(4)"> <text>Possesses a valid CLIA certificate for the complexity of the testing performed;</text> </paragraph> <paragraph num="(5)"> <text>Does not possess a Maryland permit for offering to perform or performing medical laboratory testing; and</text> </paragraph> <paragraph num="(6)"> <text>Meets the requirements for a laboratory to operate under a letter of exception — limited testing for rare diseases.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Research Laboratory. A research laboratory may obtain a letter of exception — limited testing for rare diseases if the laboratory meets the eligibility requirements of §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Letter of Exception — Limited Testing for Rare Diseases; Standards and Requirements."> <paragraph num="A."> <text>Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception — limited testing for rare diseases shall:</text> <paragraph num="(1)"> <text>Submit:</text> <paragraph num="(a)"> <text>A completed:</text> <paragraph num="(i)"> <text>Application as prescribed in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Report or questionnaire as required by the Secretary to determine regulatory compliance;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A copy of the laboratory's:</text> <paragraph num="(i)"> <text>Current CLIA certificate issued by CMS; and</text> </paragraph> <paragraph num="(ii)"> <text>Most recent CLIA survey report;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation of the rare disease testing offered or performed, including but not limited to:</text> <paragraph num="(i)"> <text>The test procedure, including instructions for quality control and quality assurance;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the disease or condition;</text> </paragraph> <paragraph num="(iii)"> <text>An explanation of the clinical validity of the test;</text> </paragraph> <paragraph num="(iv)"> <text>The performance characteristics of the test;</text> </paragraph> <paragraph num="(v)"> <text>The expected turnaround time for patient test results; and</text> </paragraph> <paragraph num="(vi)"> <text>Additional information necessary for determining eligibility and compliance with this subtitle; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Agree to:</text> <paragraph num="(a)"> <text>Make records and reports available to the Department as the Secretary may require;</text> </paragraph> <paragraph num="(b)"> <text>Notify the Department when a change to a licensee's rare disease testing procedure occurs for the purpose of the Department's determining whether the change is in compliance with this subtitle;</text> </paragraph> <paragraph num="(c)"> <text>Perform not more than 50 rare disease tests each year on specimens from Maryland patients; and</text> </paragraph> <paragraph num="(d)"> <text>Submit to the Department statistics that detail the number and types of rare disease tests performed each year on specimens from Maryland patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Standards. A person that wishes to obtain and maintain a letter of exception — limited testing for rare diseases shall:</text> <paragraph num="(1)"> <text>Comply with good laboratory practices that include:</text> <paragraph num="(a)"> <text>Following the manufacturer's instructions for instrument or test system operation and test performance;</text> </paragraph> <paragraph num="(b)"> <text>Having and following a written procedure manual describing the processes for performing tests and reporting patient test results;</text> </paragraph> <paragraph num="(c)"> <text>Performing applicable instrument calibration procedures at least once every 6 months;</text> </paragraph> <paragraph num="(d)"> <text>Performing and documenting quality control procedures using applicable levels of control materials each day of testing; and</text> </paragraph> <paragraph num="(e)"> <text>Performing and documenting that remedial action has been taken when problems or errors are identified; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet the requirements and standards in this subtitle applicable to a permitted laboratory including:</text> <paragraph num="(a)"> <text>Proficiency testing under COMAR 10.10.05;</text> </paragraph> <paragraph num="(b)"> <text>Quality assurance under COMAR 10.10.06;</text> </paragraph> <paragraph num="(c)"> <text>Personnel under COMAR 10.10.07;</text> </paragraph> <paragraph num="(d)"> <text>Sanctions under COMAR 10.10.08; and</text> </paragraph> <paragraph num="(e)"> <text>CLIA regulations incorporated by reference at COMAR 10.10.01.04B(3) — (5).</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If the submitted application and explanatory documentation do not meet the requirements of this regulation or if the information submitted for the plan is insufficient to make a determination of compliance with this subtitle, a person may:</text> <paragraph num="(1)"> <text>Submit amendments to the application and explanatory documentation; or</text> </paragraph> <paragraph num="(2)"> <text>Apply for a permit in accordance with this subtitle.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The OHCQ may conduct on-site surveys of a laboratory operating under a letter of exception — limited testing for rare diseases to:</text> <paragraph num="(1)"> <text>Investigate a complaint; or</text> </paragraph> <paragraph num="(2)"> <text>Determine compliance with this subtitle.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a licensee wishes to perform more than 50 rare disease tests per year, the licensee shall submit an application for and obtain a permit as required under this subtitle.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Environment Article, §6-303; Health-General Article, §§2-104(b), 17-202, 17-205—17-210, 17-212, 17-502, 17-503, 17-505, and 17-510; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); July 23, 2001 (28:14 Md. R. 1321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E adopted effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787); April 13, 2015 (42:7 Md. R. 568)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 1, 2004 (31:25 Md. R. 1789); amended permanently effective January 6, 2005 (31:26 Md. R. 1863); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 29, 2005 (32:17 Md. R. 1438); February 22, 2010 (37:4 Md. R. 341); April 16, 2012 (39:7 Md. R. 492); November 12, 2012 (39:22 Md. R. 1428); April 1, 2013 (40:6 Md. R. 473); March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective November 12, 2012 (39:22 Md. R. 1428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective June 1, 2009 (36:11 Md. R. 787); August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, E amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="04" heading="Medical Laboratories"> <annotations> <annotation type="Authority">Health-General Article, §§17-202, 17-204, 17-205, 17-207, 17-209, 17-502, 17-503, and 17-506, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 19, 1990 (17:3 Md. R. 297)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B and C amended effective December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new Regulations .01—.19 adopted effective February 26, 1996 (23:4 Md. R. 273)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Cholesterol Testing, repealed and new chapter, Medical Laboratories — Fees, adopted effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 23, 2001 (28:14 Md. R. 1321); June 1, 2009 (36:11 Md. R. 787); August 19, 2013 (40:16 Md. R. 1344); December 21, 2015 (42:25 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Medical Laboratories — Fees renamed Medical Laboratories effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective March 1, 2026 (52:24 Md. R. 1198)</annotation> </annotations> </chapter> <chapter num="05" heading="Medical Laboratories — Proficiency Testing"> <regulation prefix="Regulation" num=".01" heading="Participation and Evaluation."> <paragraph num="A."> <text>Participation. A licensee operating under a permit shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Enrolls in and participates satisfactorily in a PT program that meets the criteria set forth in this chapter for each of the tests that the laboratory offers to perform or performs;</text> </paragraph> <paragraph num="(2)"> <text>Tests PT samples in the same manner and number of times that it routinely tests patient specimens; and</text> </paragraph> <paragraph num="(3)"> <text>Complies with the applicable standards contained in 42 CFR §§493.801—493.807.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Evaluation — General. When a PT program does not evaluate a participating laboratory's PT results or the evaluated PT results are inconsistent with satisfactory performance, the participating laboratory and the OHCQ shall evaluate the PT results by comparing them to the all-method-results mean, all-instrument-results mean, or the all-participant-results mean found in the PT program's summaries of PT results.</text> </paragraph> <paragraph num="C."> <text>Evaluation — Departmental.</text> <paragraph num="(1)"> <text>Administrative Procedures.</text> <paragraph num="(a)"> <text>Submission of Results. The OHCQ shall monitor for regulatory purposes only official results sent directly from the PT program.</text> </paragraph> <paragraph num="(b)"> <text>Multiple Programs. If a licensee enrolls in more than one PT program and duplicate testing and reporting occurs, the licensee shall notify the OHCQ which PT program is to be scored for regulatory purposes.</text> </paragraph> <paragraph num="(c)"> <text>Sample Testing. A licensee shall operate under the following PT procedures:</text> <paragraph num="(i)"> <text>PT samples shall be tested each time a shipment is received and for only those procedures offered or allowed under a laboratory's license;</text> </paragraph> <paragraph num="(ii)"> <text>If a test is no longer offered or performed, the licensee shall inform the OHCQ in writing;</text> </paragraph> <paragraph num="(iii)"> <text>PT samples shall be tested only in the laboratory for which they are intended;</text> </paragraph> <paragraph num="(iv)"> <text>PT samples shall be handled, processed, and tested in the same manner as patient specimens; and</text> </paragraph> <paragraph num="(v)"> <text>Repeat testing may not be performed on PT samples unless it is the laboratory's policy to test patients in duplicate or if abnormal test results are routinely repeated to verify accuracy.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Testing and Reporting Deadlines.</text> <paragraph num="(i)"> <text>A licensee shall test PT samples and report PT results within the time limits set by the PT program.</text> </paragraph> <paragraph num="(ii)"> <text>PT results submitted late by a licensee are deemed unsatisfactory by the PT program and the OHCQ.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>PT Program Evaluation Errors. A licensee is responsible for seeing that an evaluation error on the PT report is corrected by the PT program and that the program sends a corrected PT report to the OHCQ.</text> </paragraph> <paragraph num="(f)"> <text>Performance Records. A laboratory's marginal or unsatisfactory PT performance may not be changed to reflect satisfactory performance when:</text> <paragraph num="(i)"> <text>PT results are not submitted;</text> </paragraph> <paragraph num="(ii)"> <text>PT results are submitted after the due date; or</text> </paragraph> <paragraph num="(iii)"> <text>Transcription errors involving PT results went unnoticed until the evaluated results were scored.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evaluation Procedures.</text> <paragraph num="(a)"> <text>Grading Criteria.</text> <paragraph num="(i)"> <text>The PT program shall score test results in terms of correlation with reference or referee laboratory test results, target values, or statistical methods based on means and standard deviations.</text> </paragraph> <paragraph num="(ii)"> <text>The OHCQ shall determine a laboratory's PT performance based on a PT program's numerical score for each specialty, subspecialty, constituent, analyte, and culture type.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Scores. Numerical PT scores required for satisfactory performance in each subdiscipline, specialty or subspecialty are as follows:</text> <paragraph num="(i)"> <text>AFP for NTD, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(ii)"> <text>Antibodies for HIV, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(iii)"> <text>Bacteriology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(iv)"> <text>Blood gases, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(v)"> <text>Blood lead, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(vi)"> <text>Chemistry, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(vii)"> <text>Coagulation, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(viii)"> <text>Cytogenetics, as set by PT program;</text> </paragraph> <paragraph num="(ix)"> <text>Drugs of abuse, forensic, equal to or greater than 90 percent;</text> </paragraph> <paragraph num="(x)"> <text>Drugs of abuse, clinical or diagnostic, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xi)"> <text>Hematology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xii)"> <text>Immunohematology, ABO and Rh typing, antibody screen, 100 percent;</text> </paragraph> <paragraph num="(xiii)"> <text>Immunohematology, antibody identification, equal to or greater than 90 percent;</text> </paragraph> <paragraph num="(xiv)"> <text>Mycology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xv)"> <text>Mycobacteriology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xvi)"> <text>Immunology, nonsyphilis serology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xvii)"> <text>Parasitology, equal to or greater than 80 percent;</text> </paragraph> <paragraph num="(xviii)"> <text>Syphilis serology, equal to or greater than 80 percent; and</text> </paragraph> <paragraph num="(xix)"> <text>Urinalysis, equal to or greater than 80 percent.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Scoring Criteria. A percent score is derived by dividing the number of satisfactory PT results by the total number of PT results for each subdiscipline, specialty, subspecialty, or individual constituent or analyte within a subspecialty.</text> </paragraph> <paragraph num="(d)"> <text>PT Failure. PT scores lower than the percent scores listed in §C(2)(b) of this regulation are failing scores.</text> </paragraph> <paragraph num="(e)"> <text>Evaluated PT Results. PT results evaluated in determining PT performance include PT results not evaluated by the PT program, code 10 results, for example, 10E, 10G, 10T, and codes of tests not performed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Initial or Single PT Failure.</text> <paragraph num="(a)"> <text>Licensee Action. A licensee shall investigate a single or initial PT failure and document the corrective action taken.</text> </paragraph> <paragraph num="(b)"> <text>Departmental Procedures. The OHCQ shall document an initial or single PT failure and may request a licensee to submit a plan of correction and supporting documentation related to the failure.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Marginal PT Performance.</text> <paragraph num="(a)"> <text>Test Scores. PT performance is marginal when a laboratory exhibits failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol.</text> </paragraph> <paragraph num="(b)"> <text>Departmental Procedures. The OHCQ shall:</text> <paragraph num="(i)"> <text>Document the marginal PT;</text> </paragraph> <paragraph num="(ii)"> <text>Send written notice of the marginal PT to the licensee; and</text> </paragraph> <paragraph num="(iii)"> <text>Request the licensee to submit a written plan of correction.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Laboratory Actions. A licensee shall submit to the OHCQ a written plan of correction that describes the investigation and steps taken to improve the applicable test performance.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Unsatisfactory PT Performance. PT performance is unsatisfactory when a laboratory exhibits:</text> <paragraph num="(a)"> <text>Failing PT scores in three of four consecutive testing events in a subdiscipline, specialty, or individual constituent or analyte, for example, Na, RBC, cholesterol;</text> </paragraph> <paragraph num="(b)"> <text>Failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol, and the next PT report for the test states “test not performed”; or</text> </paragraph> <paragraph num="(c)"> <text>An average PT score for a test over the last four consecutive testing events that falls below the minimum percent score set forth in §C(2)(b) of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Discipline, Specialty, and Subspecialty."> <paragraph num="A."> <text>Primary Standard. A licensee operating under a permit shall ensure that the laboratory participates successfully in PT, when applicable, for each test or analyte in each of the following disciplines, subdisciplines, and specialties:</text> <paragraph num="(1)"> <text>Microbiology, including the subdisciplines of:</text> <paragraph num="(a)"> <text>Bacteriology;</text> </paragraph> <paragraph num="(b)"> <text>Mycobacteriology;</text> </paragraph> <paragraph num="(c)"> <text>Mycology;</text> </paragraph> <paragraph num="(d)"> <text>Parasitology; and</text> </paragraph> <paragraph num="(e)"> <text>Virology;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Immunology, including the subdisciplines of:</text> <paragraph num="(a)"> <text>General immunology;</text> </paragraph> <paragraph num="(b)"> <text>General serology; and</text> </paragraph> <paragraph num="(c)"> <text>Syphilis serology;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Chemistry, including the subdisciplines of:</text> <paragraph num="(a)"> <text>Blood gas analysis;</text> </paragraph> <paragraph num="(b)"> <text>Endocrinology;</text> </paragraph> <paragraph num="(c)"> <text>Routine chemistry; and</text> </paragraph> <paragraph num="(d)"> <text>Toxicology;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Genetics, including the subdisciplines of:</text> <paragraph num="(a)"> <text>Biochemical genetics;</text> </paragraph> <paragraph num="(b)"> <text>Cytogenetics; and</text> </paragraph> <paragraph num="(c)"> <text>Molecular genetics;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Hematology, including the subdisciplines of:</text> <paragraph num="(a)"> <text>Coagulation testing; and</text> </paragraph> <paragraph num="(b)"> <text>Routine hematology;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Pathology, including the subdiscipline of gynecologic cytology;</text> </paragraph> <paragraph num="(7)"> <text>Immunohematology, including the specialties of:</text> <paragraph num="(a)"> <text>ABO group and D(Rho) typing;</text> </paragraph> <paragraph num="(b)"> <text>Unexpected antibody detection, that is, antibody screen;</text> </paragraph> <paragraph num="(c)"> <text>Antibody identification; and</text> </paragraph> <paragraph num="(d)"> <text>Compatibility testing; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Forensic toxicology limited to job-related alcohol and controlled dangerous substances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Discipline Standards.</text> <paragraph num="(1)"> <text>General. A licensee operating under a permit shall ensure that the laboratory meets the applicable PT standards set forth in this chapter and in 42 CFR §§493.821493.865.</text> </paragraph> <paragraph num="(2)"> <text>Gynecologic Cytology. A licensee operating under a permit to perform gynecologic cytology shall ensure that the laboratory enrolls and maintains successful participation in a cytology PT program approved by CMS.</text> </paragraph> <paragraph num="(3)"> <text>Job-Related Testing.</text> <paragraph num="(a)"> <text>A licensee operating under a permit to perform job-related testing for alcohol or controlled dangerous substances shall ensure that the laboratory enrolls and continues to participate satisfactorily, when applicable, in one or more of the programs listed in §B(3)(b)(e) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>Screening Tests. A licensee operating under a permit to perform screening tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in:</text> <paragraph num="(i)"> <text>The American Association of Bioanalysts (AAB) Urine Toxicology Screening survey;</text> </paragraph> <paragraph num="(ii)"> <text>The American Association for Clinical Chemistry/College of American Pathologists (AACC/CAP) Forensic Urine Drug Testing Screening survey; or</text> </paragraph> <paragraph num="(iii)"> <text>Another program approved by the Secretary as set forth in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Confirmation Tests. A licensee operating under a permit to perform confirmation tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in:</text> <paragraph num="(i)"> <text>The AACC/CAP Forensic Urine Drug Testing Confirmatory survey;</text> </paragraph> <paragraph num="(ii)"> <text>The federal Substance Abuse and Mental Health Services Administration's Federal Workplace Drug Testing Program; or</text> </paragraph> <paragraph num="(iii)"> <text>Another program approved by the Secretary as set forth in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Blood Alcohol Tests. A licensee operating under a permit to perform tests for alcohol in blood shall ensure that the laboratory enrolls and participates satisfactorily in:</text> <paragraph num="(i)"> <text>The AACC/CAP survey for whole blood alcohol or serum alcohol, or both; or</text> </paragraph> <paragraph num="(ii)"> <text>Another program approved by the Secretary as set forth in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Hair Analysis. A licensee operating under a permit to perform tests for a controlled dangerous substance in hair shall ensure that the laboratory enrolls and participates satisfactorily in:</text> <paragraph num="(i)"> <text>The State of Florida's P.T. program for drug testing in hair; or</text> </paragraph> <paragraph num="(ii)"> <text>Another program that possesses standards set by the Secretary or that are equivalent to the State of Florida's PT program for drug testing in hair and is approved by the Secretary as set forth in Regulation .03 of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Approval."> <paragraph num="A."> <text>Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a PT program in this State without first obtaining program approval from CMS or the OHCQ.</text> </paragraph> <paragraph num="B."> <text>Approval Granted Automatically. Except in the discipline of job-related alcohol and controlled dangerous substances, or other disciplines, subdisciplines, or specialties not covered by federal PT requirements, a PT program is approved when it is based on written evidence issued by CMS showing the program meets CMS's criteria for approval of PT programs as set forth in 42 CFR §§493.901—493.959.</text> </paragraph> <paragraph num="C."> <text>Approval Granted by the Secretary. The OHCQ may approve a PT program for a laboratory discipline, subdiscipline, or specialty not approved by CMS, if the program:</text> <paragraph num="(1)"> <text>Provides reliable, documented evidence that the program is technically and administratively able to meet the applicable requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Uniformly and routinely prepares and submits directly to the OHCQ evaluations of all PT results from all laboratories enrolled in the program and holding a Maryland permit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Cytology — Departmental Requirements."> <paragraph num="A."> <text>The Secretary may not issue a license to operate a laboratory that examines gynecologic cytology specimens if the laboratory does not enroll and participate satisfactorily in a cytology PT program approved by CMS.</text> </paragraph> <paragraph num="B."> <text>The OHCQ shall evaluate an individual's PT performance as set forth in 42 CFR §493.945.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Cytology — Laboratory and Individual Standards."> <paragraph num="A."> <text>Primary Standard. A pathologist or cytotechnologist who examines gynecological cytology specimens from individuals in this State shall participate satisfactorily in an annual cytology PT program approved by CMS.</text> </paragraph> <paragraph num="B."> <text>Laboratory Standards.</text> <paragraph num="(1)"> <text>A licensee operating under a permit to examine gynecologic cytology specimens shall ensure that each pathologist and cytotechnologist who examines gynecologic cytology specimens participates in a cytology PT program conducted by the Department or approved by CMS.</text> </paragraph> <paragraph num="(2)"> <text>A licensee employing an individual who has failed a second testing event in an annual PT cycle shall:</text> <paragraph num="(a)"> <text>Prohibit the individual from examining gynecologic specimens and provide or secure remedial training and education in gynecologic cytology for the individual, which training and education includes examination by the individual of gynecologic specimens in the individual's area of failure; and</text> </paragraph> <paragraph num="(b)"> <text>Document the individual's completion of education and training.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee employing an individual who has failed a first or subsequent PT event and who does not obtain mandated retesting or retraining, or both, shall:</text> <paragraph num="(a)"> <text>Immediately remove that individual from a position of examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the OHCQ within 30 days after being informed of the individual's last test failure that the individual is no longer examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Individual Standards.</text> <paragraph num="(1)"> <text>A cytotechnologist or pathologist who examines gynecological cytology specimens shall participate in an annual PT event that involves the examination of a 10-slide or 20-slide test set as set forth in 42 CFR §493.945.</text> </paragraph> <paragraph num="(2)"> <text>An individual passes a testing event and performs satisfactorily in PT when the individual scores at least 90 percent on a 10-slide or 20-slide test set.</text> </paragraph> <paragraph num="(3)"> <text>An individual fails a testing event and performs unsatisfactorily in PT if the individual:</text> <paragraph num="(a)"> <text>Scores less than 90 percent on a 10-slide or 20-slide test set; or</text> </paragraph> <paragraph num="(b)"> <text>Fails to take a scheduled retest without prior Department approval.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual who fails the annual testing event shall take a second test with another 10-slide test set:</text> <paragraph num="(a)"> <text>Within 45 days after receiving notice of a test failure; or</text> </paragraph> <paragraph num="(b)"> <text>At a later date with prior Department approval.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An individual who fails a second test shall:</text> <paragraph num="(a)"> <text>Cease examining gynecologic specimens immediately upon being notified of the second failure;</text> </paragraph> <paragraph num="(b)"> <text>Complete at least 40 hours of remedial training and education in gynecologic cytology that includes examining gynecological specimens in the area of failure;</text> </paragraph> <paragraph num="(c)"> <text>Complete the required training and education in a laboratory that operates under a:</text> <paragraph num="(i)"> <text>State permit for in-State laboratories; or</text> </paragraph> <paragraph num="(ii)"> <text>Certificate issued by CMS in the subdiscipline of gynecologic cytology for out-of-State laboratories;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Document the required remedial training and education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ;</text> </paragraph> <paragraph num="(e)"> <text>Schedule and take a third test with a 20-slide test set within 30 days of completing the required remedial training and education; and</text> </paragraph> <paragraph num="(f)"> <text>Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the third test.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An individual who fails a third or subsequent test shall:</text> <paragraph num="(a)"> <text>Complete at least 35 hours of documented, formally structured, continuing education in diagnostic cytopathology that focuses on the examination of gynecologic preparations;</text> </paragraph> <paragraph num="(b)"> <text>Document the education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ;</text> </paragraph> <paragraph num="(c)"> <text>Schedule and take a subsequent test with a 20-slide test set within 30 days of completing the required continuing education; and</text> </paragraph> <paragraph num="(d)"> <text>Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the test required under §C(6)(c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>An individual who fails a first or subsequent testing event in an annual PT cycle and who chooses not to complete mandatory retesting or remedial training, or both, shall:</text> <paragraph num="(a)"> <text>Immediately cease examining gynecologic cytology specimens and notify the OHCQ of this in writing; and</text> </paragraph> <paragraph num="(b)"> <text>Reenter the PT process at the point where the individual previously chose to withdraw from the testing process, if the individual decides at a later date to satisfy PT requirements.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-202 and 17-211, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 5, 1998 (25:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories — Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective November 29, 2010 (37:24 Md. R. 1658)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective November 29, 2010 (37:24 Md. R. 1658)</annotation> </annotations> </chapter> <chapter num="06" heading="Medical Laboratories — Quality Assurance"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>Primary Standards. To obtain or maintain a permit to operate a laboratory, a person or licensee shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Establishes and follows written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total, that is, preanalytic, analytic, and postanalytic phases of the testing process;</text> </paragraph> <paragraph num="(2)"> <text>Maintains a quality assurance program that:</text> <paragraph num="(a)"> <text>Continually evaluates the effectiveness of the laboratory's policies and procedures;</text> </paragraph> <paragraph num="(b)"> <text>Routinely revises policies and procedures based on the results of on-going evaluation;</text> </paragraph> <paragraph num="(c)"> <text>Identifies and corrects problems;</text> </paragraph> <paragraph num="(d)"> <text>Assures accurate, reliable, and prompt reporting of test results;</text> </paragraph> <paragraph num="(e)"> <text>Assures adequate and competent personnel; and</text> </paragraph> <paragraph num="(f)"> <text>Documents all quality assurance activities; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Establishes and maintains a laboratory safety program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards. A licensee shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Meets the applicable:</text> <paragraph num="(a)"> <text>Quality assurance standards set forth in this chapter and in 42 CFR §§493.1230 — 493.1299; and</text> </paragraph> <paragraph num="(b)"> <text>Quality testing standards for facility administration set forth in this chapter and in 42 CFR §§493.1100 — 493.1101;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Establishes, maintains, and enforces a laboratory safety program that:</text> <paragraph num="(a)"> <text>Provides all personnel with access to a safety manual covering the following topics, when applicable:</text> <paragraph num="(i)"> <text>General personnel safety;</text> </paragraph> <paragraph num="(ii)"> <text>Fire prevention and control;</text> </paragraph> <paragraph num="(iii)"> <text>Biological hazards;</text> </paragraph> <paragraph num="(iv)"> <text>Chemical hazards;</text> </paragraph> <paragraph num="(v)"> <text>Radiological hazards;</text> </paragraph> <paragraph num="(vi)"> <text>Special medical waste disposal; and</text> </paragraph> <paragraph num="(vii)"> <text>The reporting of incidents and accidents; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Complies with the following applicable federal Occupational Safety and Health Administration standards:</text> <paragraph num="(i)"> <text>“Occupational Exposure to Hazardous Chemicals in Laboratories”, contained in 29 CFR §1910.1450; and</text> </paragraph> <paragraph num="(ii)"> <text>“Bloodborne Pathogens,” contained in 29 CFR §1910.1030; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Maintains a collection station:</text> <paragraph num="(a)"> <text>As part of and under the direction of the laboratory for which it collects specimens; and</text> </paragraph> <paragraph num="(b)"> <text>With equipment and staff appropriate for the collection, preservation, storage, and maintenance of specimens in a manner suitable for later examination.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Authorization to Request Laboratory Tests."> <paragraph num="A."> <text>Primary Standard. A laboratory may not perform a laboratory test, except under a health awareness permit or cholesterol permit, without obtaining written or electronic authorization from:</text> <paragraph num="(1)"> <text>A court of law;</text> </paragraph> <paragraph num="(2)"> <text>A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or</text> </paragraph> <paragraph num="(3)"> <text>Another person authorized to order laboratory tests under the Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Other Authorized Persons. Other persons authorized to order laboratory tests include:</text> <paragraph num="(1)"> <text>A nurse midwife certified by the Maryland State Board of Nursing under COMAR 10.27.05;</text> </paragraph> <paragraph num="(2)"> <text>A nurse practitioner certified by the Maryland State Board of Nursing under COMAR 10.27.07;</text> </paragraph> <paragraph num="(3)"> <text>A physician's assistant, as authorized by the physician's assistant's supervising physician;</text> </paragraph> <paragraph num="(4)"> <text>A chiropractor requesting a test on blood or urine;</text> </paragraph> <paragraph num="(5)"> <text>An employer requesting a job-related test for alcohol or controlled dangerous substances;</text> </paragraph> <paragraph num="(6)"> <text>Clinical staff who:</text> <paragraph num="(a)"> <text>Meets the qualifications set forth in COMAR 10.47.01.06D;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and</text> </paragraph> <paragraph num="(c)"> <text>Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A pharmacist, for tests that qualify for a letter of exception under COMAR 10.10.03.02B and for glucose, A1c, lipids (including total cholesterol, HDL, LDL, and triglycerides), AST, and ALT; and</text> </paragraph> <paragraph num="(8)"> <text>A naturopathic physician consistent with Health Occupations Article, §14–5F–01 through §14–5F–32, Annotated Code of Maryland and COMAR 10.32.21.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Standards. A licensee shall ensure that the laboratory meets the applicable standards concerning test requisition contained in 42 CFR §493.1241.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Patient Test Management."> <paragraph num="A."> <text>Primary Standard. A licensee shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Provides patient manipulation by qualified personnel; and</text> </paragraph> <paragraph num="(2)"> <text>Employs and maintains a quality assurance program that provides for:</text> <paragraph num="(a)"> <text>Proper patient preparation;</text> </paragraph> <paragraph num="(b)"> <text>Proper specimen:</text> <paragraph num="(i)"> <text>Collection;</text> </paragraph> <paragraph num="(ii)"> <text>Identification;</text> </paragraph> <paragraph num="(iii)"> <text>Preservation;</text> </paragraph> <paragraph num="(iv)"> <text>Transportation; and</text> </paragraph> <paragraph num="(v)"> <text>Processing;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Record maintenance; and</text> </paragraph> <paragraph num="(d)"> <text>Accurate reporting of results.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Standard — Patient Manipulation and Specimen Collection.</text> <paragraph num="(1)"> <text>A person may not manipulate a patient, for example, to collect specimens unless the person is:</text> <paragraph num="(a)"> <text>A licensed:</text> <paragraph num="(i)"> <text>Physician; or</text> </paragraph> <paragraph num="(ii)"> <text>Nurse;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Authorized by law to:</text> <paragraph num="(i)"> <text>Collect a specimen from an individual for medical laboratory testing; or</text> </paragraph> <paragraph num="(ii)"> <text>Manipulate a patient; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Employed by a licensee under this title.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee shall ensure that specimens for laboratory testing are collected by individuals who are trained in and have documented experience in:</text> <paragraph num="(a)"> <text>Preparing patients for specimen collection; and</text> </paragraph> <paragraph num="(b)"> <text>Collecting the appropriate specimen required for the requested test.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Qualified personnel authorized by the licensee may collect:</text> <paragraph num="(a)"> <text>Blood specimens, including:</text> <paragraph num="(i)"> <text>Venipuncture; and</text> </paragraph> <paragraph num="(ii)"> <text>Finger or heel stick whole-blood specimens;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Stomach contents; and</text> </paragraph> <paragraph num="(c)"> <text>Clinical materials for smears and culture, for example, throat and nasopharyngeal swabs, and other specimens required to perform a requested test under the direction or on the written request of a physician or other person authorized by law and identified in Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An employer may collect a specimen for job-related testing to determine use or abuse of a controlled dangerous substance or alcohol as set forth under COMAR 10.10.10.</text> </paragraph> <paragraph num="(5)"> <text>A person collecting specimens for medical laboratory testing or examination shall follow the licensee's policies and procedures contained in the laboratory's quality assurance system as set forth in §C of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>This section does not apply to the collection of a DNA specimen with a buccal swab used for determining paternity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Standard — Quality Assurance. A licensee shall ensure that the laboratory's quality assurance system:</text> <paragraph num="(1)"> <text>Provides optimum patient test results by establishing and maintaining mechanisms to preserve specimen integrity and maintain positive specimen identification throughout the entire testing process, including the:</text> <paragraph num="(a)"> <text>Preanalytic phase;</text> </paragraph> <paragraph num="(b)"> <text>Analytic phase; and</text> </paragraph> <paragraph num="(c)"> <text>Postanalytic phase; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meets the applicable standards contained in 42 CFR §§493.1230 — 493.1234, 493.1240 — 493.1249, and 493.1281—493.1299.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reporting and Releasing Test Results."> <paragraph num="A."> <text>Primary Standard. A laboratory shall report or release test results, except results of a health awareness test, only to an authorized person.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>For all test results except those from a health awareness test performed at a temporary laboratory or from a job-related alcohol or controlled dangerous substance test, a licensee shall ensure that the laboratory:</text> <paragraph num="(a)"> <text>Reports medical test results only to the physician, dentist, or other authorized person who requested the test, or to another laboratory that requested the test;</text> </paragraph> <paragraph num="(b)"> <text>Sends a copy of a test result, other than a result for a health awareness or job-related alcohol or controlled dangerous substances test, directly to the individual tested only after the laboratory:</text> <paragraph num="(i)"> <text>Receives a written request from the individual; and</text> </paragraph> <paragraph num="(ii)"> <text>Notifies the authorized person who requested the test that the results will be released to the individual tested;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Meets the applicable standards concerning test reports contained in 42 CFR §§493.1234 and 493.1291; and</text> </paragraph> <paragraph num="(d)"> <text>Reports a test result on a form that identifies the name and address of the laboratory that performed the test.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For test results stemming from a health awareness test, set forth in COMAR 10.10.01.03B, and performed at a temporary laboratory, the laboratory may report those results directly to the individual tested.</text> </paragraph> <paragraph num="(3)"> <text>If the results of the tests listed in Regulation .02B(7) of this chapter are not within the desired range, the pharmacist shall provide:</text> <paragraph num="(a)"> <text>The test results to the patient’s primary care practitioner for evaluation and treatment; or</text> </paragraph> <paragraph num="(b)"> <text>The patient with a referral to a licensed independent practitioner for evaluation and treatment.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Control — General."> <paragraph num="A."> <text>Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written quality control procedures for monitoring and evaluating the quality of the analytic phase of the testing process for each testing method and procedure to assure the accuracy and reliability of patient test results and reports.</text> </paragraph> <paragraph num="B."> <text>Standard. A licensee shall ensure that the laboratory meets the applicable quality control standards as set forth in this chapter and in 42 CFR §§493.1200—493.1299.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Quality Control — Quality Control Program."> <paragraph num="A."> <text>Primary Standard. A licensee shall develop, establish, implement, maintain, and follow quality control policies, procedures, and techniques that ensure accurate and reliable test results and patient test reports.</text> </paragraph> <paragraph num="B."> <text>Standard — Quality Control Program. A licensee's quality control program shall:</text> <paragraph num="(1)"> <text>Cover all tests and related examinations and procedures performed by the laboratory; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the standards and requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Standard — Quality Control Practices. A licensee's quality control practices shall include, but are not limited to, the use of:</text> <paragraph num="(1)"> <text>Analyses of reference materials to ensure that test results are:</text> <paragraph num="(a)"> <text>Reproducible;</text> </paragraph> <paragraph num="(b)"> <text>Accurate; and</text> </paragraph> <paragraph num="(c)"> <text>Reliable;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Systems to ensure proper functioning of:</text> <paragraph num="(a)"> <text>Instruments;</text> </paragraph> <paragraph num="(b)"> <text>Equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Reagents;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Validity, calibration, and systematic procedural checks for:</text> <paragraph num="(a)"> <text>Reagents;</text> </paragraph> <paragraph num="(b)"> <text>Equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Test systems; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Systems for:</text> <paragraph num="(a)"> <text>Review and reporting of test results that ensure timely error detection and correction; and</text> </paragraph> <paragraph num="(b)"> <text>Assessment of laboratory personnel:</text> <paragraph num="(i)"> <text>Performance;</text> </paragraph> <paragraph num="(ii)"> <text>Proficiency; and</text> </paragraph> <paragraph num="(iii)"> <text>Competency.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Standard — Adequacy of Methods and Equipment. A licensee shall:</text> <paragraph num="(1)"> <text>Employ methods and equipment that provide accurate and reliable test results and reports;</text> </paragraph> <paragraph num="(2)"> <text>Have sufficient and suitable equipment and instruments to perform the type of testing services and volume of tests offered by the laboratory;</text> </paragraph> <paragraph num="(3)"> <text>Monitor all test methods, instruments, and test systems for the following performance characteristics, when applicable:</text> <paragraph num="(a)"> <text>Detection limits for each:</text> <paragraph num="(i)"> <text>Method;</text> </paragraph> <paragraph num="(ii)"> <text>Instrument; and</text> </paragraph> <paragraph num="(iii)"> <text>Test system;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Precision;</text> </paragraph> <paragraph num="(c)"> <text>Accuracy;</text> </paragraph> <paragraph num="(d)"> <text>Specificity;</text> </paragraph> <paragraph num="(e)"> <text>Sensitivity;</text> </paragraph> <paragraph num="(f)"> <text>Test interferences; and</text> </paragraph> <paragraph num="(g)"> <text>Other related test variables that affect test results;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have adequate systems in place to:</text> <paragraph num="(a)"> <text>Ensure that a statistically valid number of counts or measurement levels are obtained and verified to give accurate and reliable test results for systems each day instruments and equipment such as cell counters, radiation counters, and spectrophotometers are used; and</text> </paragraph> <paragraph num="(b)"> <text>Report results in an accurate and reliable manner and within the time frames established by the laboratory; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Perform test methods and use instrumentation in a manner that permits the laboratory to provide accurate and reliable test results within the laboratory's stated performance criteria.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Standard — Supplies, Reagents, and Materials. A licensee shall ensure that supplies, reagents, and other materials used in the collection, handling, testing, and storing of specimens in the laboratory are stored, labeled, checked for proper reactivity, and used according to §§F — I of this regulation.</text> </paragraph> <paragraph num="F."> <text>Storage. A licensee shall ensure that laboratory materials are stored in the manner stated by the manufacturer.</text> </paragraph> <paragraph num="G."> <text>Labeling. A licensee shall ensure that laboratory testing materials, including reagents, solutions, culture media, controls, and calibrators are labeled to indicate the:</text> <paragraph num="(1)"> <text>Identity;</text> </paragraph> <paragraph num="(2)"> <text>Concentration, strength, or titer;</text> </paragraph> <paragraph num="(3)"> <text>Storage requirements;</text> </paragraph> <paragraph num="(4)"> <text>Preparation and expiration dates;</text> </paragraph> <paragraph num="(5)"> <text>Identity of the preparer; and</text> </paragraph> <paragraph num="(6)"> <text>Other pertinent information that would affect test performance or outcome.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reactivity Checks. A licensee shall ensure that representative samples of each lot of materials used for or in the process of testing specimens are tested on a regularly scheduled basis to determine each material's capacity to perform as required.</text> </paragraph> <paragraph num="I."> <text>Use of Supplies and Other Materials. A licensee:</text> <paragraph num="(1)"> <text>May not use materials that have:</text> <paragraph num="(a)"> <text>Exceeded the material's expiration date;</text> </paragraph> <paragraph num="(b)"> <text>Substandard reactivity; or</text> </paragraph> <paragraph num="(c)"> <text>Deteriorated; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall use supplies, reagents, kits, identification systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Quality Control — Single-Use Test Devices. — Repealed." /> <regulation prefix="Regulation" num=".07" heading="Quality Control — Specialty and Subspecialty."> <paragraph num="A."> <text>Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written policies and procedures for a comprehensive quality control program that includes verification and assessment of accuracy, measurement of precision, and detection of error for all analyses and procedures performed by the laboratory.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>General. A licensee shall ensure that the laboratory meets the applicable quality control requirements for each specialty and subspecialty under:</text> <paragraph num="(a)"> <text>42 CFR §§493.1200—493.1299; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations .07—.15 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cholesterol. A licensee or approved plan holder of a laboratory that performs cholesterol tests shall ensure that the laboratory obtains and maintains control samples at two levels, near or bracketing the 200 and 240 micrograms/deciliter decision levels.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Quality Control — Job-Related Alcohol and Drug Testing."> <paragraph num="A."> <text>Primary Standard. A licensee shall ensure that a laboratory has in place a quality assurance program designed to monitor and evaluate all phases of the testing process including but not limited to:</text> <paragraph num="(1)"> <text>Laboratory certification;</text> </paragraph> <paragraph num="(2)"> <text>Specimens, specimen collection, chain of custody, and transport;</text> </paragraph> <paragraph num="(3)"> <text>Security and controlled access;</text> </paragraph> <paragraph num="(4)"> <text>Storage and specimen retention;</text> </paragraph> <paragraph num="(5)"> <text>Analytical methods and procedures;</text> </paragraph> <paragraph num="(6)"> <text>Accuracy, precision, and reliability;</text> </paragraph> <paragraph num="(7)"> <text>Reporting test results; and</text> </paragraph> <paragraph num="(8)"> <text>Proficiency testing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Certification. A licensee of a laboratory that offers to perform or performs screening or confirmation tests for alcohol or controlled dangerous substances shall ensure that the laboratory is inspected and certified to perform tests for alcohol or controlled dangerous substances by:</text> <paragraph num="(a)"> <text>The Secretary;</text> </paragraph> <paragraph num="(b)"> <text>The College of American Pathologists;</text> </paragraph> <paragraph num="(c)"> <text>The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or</text> </paragraph> <paragraph num="(d)"> <text>A government agency, program, or accrediting organization approved by the Secretary as set forth in COMAR 10.10.02.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Specimens, Specimen Collection, Chain of Custody, and Transport.</text> <paragraph num="(a)"> <text>Permissible Specimens. A licensee shall ensure that job-related tests for alcohol or controlled dangerous substances are only performed using specimens derived from the human body as set forth in COMAR 10.10.10.06.</text> </paragraph> <paragraph num="(b)"> <text>A licensee shall ensure that a specimen is processed, handled, and transported in a manner that protects the identity and physical integrity of the specimen by:</text> <paragraph num="(i)"> <text>Accepting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; and</text> </paragraph> <paragraph num="(ii)"> <text>Implementing, maintaining, and employing chain of custody procedures, including documentation of specimen handling and access, that cover the life of a specimen from the time of collection through final disposal of the specimen.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Decontamination Requirement for Hair Specimens. A licensee shall ensure that the laboratory establishes, validates, and uses a procedure to remove possible external contamination from a hair specimen before a test is performed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Security and Controlled Access. A licensee shall ensure that a specimen is collected and processed in a manner that protects the physical integrity of the specimen by:</text> <paragraph num="(a)"> <text>Collecting and processing a specimen under supervised conditions;</text> </paragraph> <paragraph num="(b)"> <text>Securing the laboratory or any portion of the laboratory used for job-related alcohol or controlled dangerous substances testing;</text> </paragraph> <paragraph num="(c)"> <text>Using and maintaining secure specimen storage areas that include, when applicable, locked freezers and refrigerators;</text> </paragraph> <paragraph num="(d)"> <text>Limiting access to testing and specimen storage facilities to authorized personnel;</text> </paragraph> <paragraph num="(e)"> <text>Exercising and maintaining control over a specimen storage area by documenting in an access log the identity, date, time of entry and exit, and the purpose for entry for each individual who enters the storage area; and</text> </paragraph> <paragraph num="(f)"> <text>Recording, reporting, and maintaining a test result in a manner that prevents alteration and breech of confidentiality by:</text> <paragraph num="(i)"> <text>Limiting access to a test result to authorized personnel; and</text> </paragraph> <paragraph num="(ii)"> <text>Preparing and storing a test result in a secured area.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Storage and Specimen Retention. A licensee shall ensure that a:</text> <paragraph num="(a)"> <text>Positive urine or hair specimen is retained in the original collection container for at least 6 months after a final test result is reported;</text> </paragraph> <paragraph num="(b)"> <text>Positive urine or blood specimen is stored at less than or equal to -20° Centigrade; and</text> </paragraph> <paragraph num="(c)"> <text>Negative specimen is retained for at least 5 days at less than or equal to room temperature.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Analytical Methods and Procedures. A licensee shall ensure that tests are performed using proven and reliable methods and procedures that are approved by the:</text> <paragraph num="(a)"> <text>Secretary;</text> </paragraph> <paragraph num="(b)"> <text>College of American Pathologists (CAP);</text> </paragraph> <paragraph num="(c)"> <text>The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or</text> </paragraph> <paragraph num="(d)"> <text>United States Food and Drug Administration (FDA).</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Approval of Methods and Procedures. The Secretary shall base approval or acceptability of any analytical method or procedure with questioned validity or reliability on evidence published in a peer-reviewed scientific journal and derived from independent:</text> <paragraph num="(a)"> <text>Scientific testing and evaluation; or</text> </paragraph> <paragraph num="(b)"> <text>Scientifically based clinical trial.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Accuracy, Precision, and Reliability. The licensee shall ensure that the laboratory employs quality control mechanisms and practices, including but not limited to those assuring accuracy, precision, and reliability of test results by:</text> <paragraph num="(a)"> <text>Using a sufficient number of reference standard samples with each batch of test specimens to ensure accuracy of the assay or procedure's linearity over time;</text> </paragraph> <paragraph num="(b)"> <text>Using reference standard samples that have values at or near the minimum drug detection levels or concentrations;</text> </paragraph> <paragraph num="(c)"> <text>Using results obtained from testing reference standard samples to document linearity and calculate test data obtained from test specimens;</text> </paragraph> <paragraph num="(d)"> <text>Including in each analytical run quality control samples that are:</text> <paragraph num="(i)"> <text>Certified to contain no alcohol or controlled dangerous substance;</text> </paragraph> <paragraph num="(ii)"> <text>Fortified with known reference standards;</text> </paragraph> <paragraph num="(iii)"> <text>Positive with the alcohol or controlled dangerous substance at or near the cutoff or minimum detection level; and</text> </paragraph> <paragraph num="(iv)"> <text>Using a total number of quality control samples in an analytical run equal to at least 5 percent of the number of specimens being tested;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Verifying and documenting at least monthly the linearity and precision of each test method and procedure; and</text> </paragraph> <paragraph num="(f)"> <text>Using methods, procedures, and techniques that prevent samples and specimens from contaminating one another throughout the testing process.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Cutoff Levels.</text> <paragraph num="(a)"> <text>A licensee that offers to perform or performs job-related alcohol or controlled dangerous substances testing shall use the established cutoff levels specified in §B(8)(b) and (c) of this regulation to distinguish a positive from a negative test specimen.</text> </paragraph> <paragraph num="(b)"> <text>Urine. A laboratory testing urine shall use the cutoff levels set forth in 49 CFR §40.85.</text> </paragraph> <paragraph num="(c)"> <text>Blood, Saliva, and Hair.</text> <paragraph num="(i)"> <text>A licensee testing blood, saliva, or hair specimens shall use the cutoff levels established by an agency of the federal government for the purpose of determining whether a specimen is positive or negative for alcohol or a controlled dangerous substance.</text> </paragraph> <paragraph num="(ii)"> <text>If cutoff levels in blood, saliva, or hair have not been established and accepted by an agency of the federal government, a licensee shall establish and use a cutoff level for each screening test and confirmatory test performed to determine whether a specimen is negative for each controlled dangerous substance that the licensee offers to detect by a screening or confirmatory procedure.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Validation. A licensee shall ensure that the:</text> <paragraph num="(i)"> <text>Laboratory maintains documented data validating each cutoff level; and</text> </paragraph> <paragraph num="(ii)"> <text>Cutoff data is made available for review by the OHCQ.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>Reporting Test Results. A licensee shall ensure that a job-related laboratory test report includes:</text> <paragraph num="(a)"> <text>A list of all the drug and alcohol tests that were performed on the specimen;</text> </paragraph> <paragraph num="(b)"> <text>Positive test results only if the specimen was found positive by a confirmation test that employed a combination of:</text> <paragraph num="(i)"> <text>Gas chromatography and mass spectrometry (GC/MS);</text> </paragraph> <paragraph num="(ii)"> <text>Mass spectrometry and mass spectrometry (MS/MS);</text> </paragraph> <paragraph num="(iii)"> <text>Gas chromatography tandem mass spectrometry (GC/MS/MS); or</text> </paragraph> <paragraph num="(iv)"> <text>Other analytical methods that use mass spectrometry as the primary detection technique;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The value at the cutoff or detection level of each test, that is, screening test or confirmation test, or both, for alcohol or a controlled dangerous substance performed on the specimen;</text> </paragraph> <paragraph num="(d)"> <text>The telephone number of the laboratory that may be used by an employer or individual who was tested to obtain technical assistance for the purpose of interpreting a positive test result; and</text> </paragraph> <paragraph num="(e)"> <text>Except as provided in Health-General Article, §17-214(i), Annotated Code of Maryland, no information to an employer or prospective employer on:</text> <paragraph num="(i)"> <text>The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or</text> </paragraph> <paragraph num="(ii)"> <text>The use of a legally prescribed drug, unless the individual tested is unable to establish that the drug was prescribed in accordance with the laws of the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Proficiency Testing. A licensee shall ensure that the laboratory enrolls and continues to participate satisfactorily in a proficiency testing program that:</text> <paragraph num="(a)"> <text>Covers each type of job-related alcohol and controlled dangerous substance test specimen analyzed; and</text> </paragraph> <paragraph num="(b)"> <text>Has the approval of the Secretary as set forth in COMAR 10.10.05.03 of this subtitle.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Repealed." /> <regulation prefix="Regulation" num=".10" heading="Quality Control — Cytology."> <paragraph num="A."> <text>Primary Standard. A licensee of a laboratory offering to perform or performing tests in the subdiscipline of gynecologic cytology shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Limits the number of slides an individual may examine as set forth in 42 CFR §493.1274;</text> </paragraph> <paragraph num="(2)"> <text>Limits slide examination to the laboratory premises;</text> </paragraph> <paragraph num="(3)"> <text>Establishes a quality assurance program and follows written quality control procedures to monitor and evaluate the quality of cytological procedures and testing processes;</text> </paragraph> <paragraph num="(4)"> <text>Does not pay for the examination of cytology slides on a piecework basis;</text> </paragraph> <paragraph num="(5)"> <text>Reviews not less than 10 percent of all negative gynecologic slides before reporting results on those slides;</text> </paragraph> <paragraph num="(6)"> <text>Employs an individual who qualifies as a supervisory cytotechnologist or a technical supervisor in gynecologic cytology to review negative gynecologic slides;</text> </paragraph> <paragraph num="(7)"> <text>Does not allow the evaluation of a slide that shows evidence of unsatisfactory preparation;</text> </paragraph> <paragraph num="(8)"> <text>Reports as to whether a slide is satisfactory or unsatisfactory for evaluation;</text> </paragraph> <paragraph num="(9)"> <text>Maintains records for 5 years of slides reported as unsatisfactory;</text> </paragraph> <paragraph num="(10)"> <text>Maintains and stores for 5 years from the date of examination any slide that was examined;</text> </paragraph> <paragraph num="(11)"> <text>Retains cytology reports for at least 10 years;</text> </paragraph> <paragraph num="(12)"> <text>Does not send gynecologic cytology slides to a laboratory not holding a State license; and</text> </paragraph> <paragraph num="(13)"> <text>Requires cytotechnologists and pathologists to obtain continuing education.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>General. A licensee shall ensure that the laboratory complies with the applicable requirements in 42 CFR §493.1221.</text> </paragraph> <paragraph num="(2)"> <text>Continuing Education.</text> <paragraph num="(a)"> <text>A cytotechnologist or pathologist who is employed by a laboratory and who performs primary gynecologic screening shall obtain at least 20 credit hours per calendar year of continuing education in cytology. A credit hour is 1 hour of active participation in the educational activity.</text> </paragraph> <paragraph num="(b)"> <text>An individual may obtain cytological continuing education in a formal or informal educational activity, such as reading journal articles, reviewing case histories, and attending lectures or workshops. This activity provides the individual with increased medical or technical knowledge of cytopathology or exfoliative cytology.</text> </paragraph> <paragraph num="(c)"> <text>A licensee shall ensure that the laboratory annually compiles records of the continuing education for each cytotechnologist and pathologist and retains them for at least 2 years.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Quality Control — Dermatopathology."> <paragraph num="A."> <text>Primary Standard. In addition to meeting the requirements of other applicable regulations of this subtitle, a licensee of a laboratory performing tests in the subdiscipline of dermatopathology shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Retains the services of either a:</text> <paragraph num="(a)"> <text>Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1); or</text> </paragraph> <paragraph num="(b)"> <text>Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4);</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintains applicable records and reports; and</text> </paragraph> <paragraph num="(3)"> <text>Effectively processes and stores specimens, slides, and tissue.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Maintenance of Records, Reports, Tissue, and Slides.</text> <paragraph num="(a)"> <text>A licensee shall ensure that the laboratory maintains a system of documentation to monitor the collection, receipt, handling, transport, processing, testing, and reporting of all specimens.</text> </paragraph> <paragraph num="(b)"> <text>A system of documentation may include:</text> <paragraph num="(i)"> <text>A laboratory specimen log book; or</text> </paragraph> <paragraph num="(ii)"> <text>Accession sheets or records.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A licensee shall ensure that the laboratory generates a written report for each patient specimen that is examined either microscopically or macroscopically. The report shall include:</text> <paragraph num="(i)"> <text>Patient name, age, and sex;</text> </paragraph> <paragraph num="(ii)"> <text>The dates of specimen collection and processing;</text> </paragraph> <paragraph num="(iii)"> <text>The source or anatomic site of a specimen;</text> </paragraph> <paragraph num="(iv)"> <text>A gross description of the specimen;</text> </paragraph> <paragraph num="(v)"> <text>A description of the tissue, for example, bisected, submitted in total, number of blocks, or that only representative sections were submitted;</text> </paragraph> <paragraph num="(vi)"> <text>The diagnosis or observed results of the test or examination;</text> </paragraph> <paragraph num="(vii)"> <text>The examining physician's name, signature, and date of report;</text> </paragraph> <paragraph num="(viii)"> <text>If appropriate, the clinical impression or differential diagnosis; and</text> </paragraph> <paragraph num="(ix)"> <text>Other pertinent or essential patient history that may affect the accuracy or reliability of the report.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A licensee shall ensure that a laboratory retains:</text> <paragraph num="(i)"> <text>Records and reports for at least 10 years for final reports and 2 years for other laboratory records;</text> </paragraph> <paragraph num="(ii)"> <text>Wet tissue or tissue remnants for 2 weeks after a final report is issued;</text> </paragraph> <paragraph num="(iii)"> <text>A specimen or tissue in a paraffin block for 5 years from the date of examination; and</text> </paragraph> <paragraph num="(iv)"> <text>Slides for 10 years from the date of examination.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A licensee shall ensure that specimens, slides, and tissues are:</text> <paragraph num="(i)"> <text>Processed in a facility licensed under this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Appropriately fixed for the tests performed;</text> </paragraph> <paragraph num="(iii)"> <text>Properly labeled with at least the patient's name or other cross-referenced identifier, such as a case or accession number; and</text> </paragraph> <paragraph num="(iv)"> <text>Adequately stored and effectively filed to allow easy access and retrieval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Quality Control. When a slide or specimen is processed or stained in the laboratory, the licensee shall ensure that:</text> <paragraph num="(a)"> <text>A staining container is labeled and covered when not in use;</text> </paragraph> <paragraph num="(b)"> <text>A stain and a working solution are changed at appropriate intervals; and</text> </paragraph> <paragraph num="(c)"> <text>Routine employee access is provided to flowcharts and other written procedures that accurately reflect the procedures in use.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Quality Control — Temporary and Mobile Laboratories: General."> <paragraph num="A."> <text>Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed:</text> <paragraph num="(1)"> <text>Under effective supervision, quality control, and safety procedures;</text> </paragraph> <paragraph num="(2)"> <text>Using a previously evaluated analytical system; and</text> </paragraph> <paragraph num="(3)"> <text>For a job-related screening test for alcohol or controlled dangerous substances, only at the request of an individual authorized in COMAR 10.10.06.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Limited Tests. A person may perform at a temporary or mobile laboratory only the health awareness tests defined in COMAR 10.10.01.03B and job-related screening tests for alcohol or controlled dangerous substances.</text> </paragraph> <paragraph num="(2)"> <text>Health awareness and cholesterol testing may be performed at the request of the examinee. Staff who perform the tests shall have training and experience to perform testing that includes:</text> <paragraph num="(a)"> <text>Operation of the analyzers per manufacturer’s recommendations;</text> </paragraph> <paragraph num="(b)"> <text>Evaluation of the results of the quality controls;</text> </paragraph> <paragraph num="(c)"> <text>Interpretation of the test results; and</text> </paragraph> <paragraph num="(d)"> <text>Counseling to the individual whose specimen is tested.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Supervision. A designated supervisor, knowledgeable in all aspects of the health awareness testing, shall be present at a temporary or mobile laboratory throughout a testing event to oversee testing, including compliance with all applicable requirements set forth in this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Testing Sites.</text> <paragraph num="(a)"> <text>A person may not perform a health awareness test in a restaurant where food or drink is prepared, served, or consumed.</text> </paragraph> <paragraph num="(b)"> <text>A licensee shall ensure that a temporary laboratory:</text> <paragraph num="(i)"> <text>Provides space, when applicable, for counseling examinees regarding test results;</text> </paragraph> <paragraph num="(ii)"> <text>Provides space appropriate for the number of staff, analytical systems, and examinees;</text> </paragraph> <paragraph num="(iii)"> <text>Provides work space adequate to minimize problems of transportation, communication, and safety;</text> </paragraph> <paragraph num="(iv)"> <text>Provides electricity of the type and in the amount needed to operate analytical systems properly;</text> </paragraph> <paragraph num="(v)"> <text>Includes access to water and disinfectant supplies for routine cleaning and disinfection of the work area, equipment, and personnel;</text> </paragraph> <paragraph num="(vi)"> <text>Contains or is within 1 minute of a telephone with access to emergency assistance by calling 911;</text> </paragraph> <paragraph num="(vii)"> <text>Maintains levels of temperature, humidity, and ventilation to comply with manufacturer's specifications for effective operation of analytical systems;</text> </paragraph> <paragraph num="(viii)"> <text>Is situated a minimum of 12 feet from any produce, meat, or dairy department in a food market;</text> </paragraph> <paragraph num="(ix)"> <text>Maintains partitions, such as ropes, on at least three sides of an area where blood is drawn or processed, to prevent unsupervised access to a blood-drawing or testing area;</text> </paragraph> <paragraph num="(x)"> <text>Employs separate receptacles for routine laboratory and special medical wastes within partitioned testing areas;</text> </paragraph> <paragraph num="(xi)"> <text>Provides for the storage of reagents and other testing materials within temperatures recommended by the manufacturer; and</text> </paragraph> <paragraph num="(xii)"> <text>Complies with all pertinent State laws and local ordinances.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Pre-Field Evaluation of Analytical Systems. A licensee may not employ an analytical system in a mobile or temporary laboratory until the laboratory has documented the analytical system's levels of accuracy and precision in a permanent laboratory facility.</text> </paragraph> <paragraph num="(6)"> <text>In-Field Quality Control. A licensee operating a mobile or temporary laboratory shall establish and maintain a continuous quality control program for an analytical system operated in that mobile or temporary laboratory.</text> </paragraph> <paragraph num="(7)"> <text>Phlebotomy Quality Control and Safety.</text> <paragraph num="(a)"> <text>A licensee employing a phlebotomist at a temporary or mobile laboratory shall ensure that the phlebotomist is trained in proper techniques for:</text> <paragraph num="(i)"> <text>Specimen collection; and</text> </paragraph> <paragraph num="(ii)"> <text>Infection control.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A licensee shall provide appropriate protective clothing and disposable gloves and ensure that they are used appropriately by all personnel involved in drawing or handling blood.</text> </paragraph> <paragraph num="(c)"> <text>A phlebotomist shall wear new gloves for each examinee.</text> </paragraph> <paragraph num="(d)"> <text>A laboratory employee shall use and clean phlebotomy devices as prescribed by the manufacturer.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Testing Logs. A licensee shall maintain for 2 years a log identifying all:</text> <paragraph num="(a)"> <text>Persons tested;</text> </paragraph> <paragraph num="(b)"> <text>Test results; and</text> </paragraph> <paragraph num="(c)"> <text>Test dates.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Results Reporting. The licensee of a temporary or mobile laboratory:</text> <paragraph num="(a)"> <text>May give results of a health awareness test immediately following the testing directly to the individual who underwent the test; and</text> </paragraph> <paragraph num="(b)"> <text>Shall give the test results in writing stating the:</text> <paragraph num="(i)"> <text>Name of the individual tested,</text> </paragraph> <paragraph num="(ii)"> <text>Name of the laboratory performing the test,</text> </paragraph> <paragraph num="(iii)"> <text>Name of the test,</text> </paragraph> <paragraph num="(iv)"> <text>Date of the test, and</text> </paragraph> <paragraph num="(v)"> <text>Test result with appropriate interpretation or reference range consistent with current nationally recognized standards.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Disposal of Special Medical Waste. A licensee operating a temporary or mobile laboratory shall dispose of special medical waste as required in COMAR 10.06.06.01—10.06.06.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Quality Control — Temporary and Mobile Laboratories: Personnel Training."> <paragraph num="A."> <text>Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>All Personnel. A licensee shall ensure that all personnel are trained to:</text> <paragraph num="(a)"> <text>Keep examinees' health information confidential;</text> </paragraph> <paragraph num="(b)"> <text>Deal with emergency situations such as fainting and anxiety reactions;</text> </paragraph> <paragraph num="(c)"> <text>Report and document information on testing services and activities; and</text> </paragraph> <paragraph num="(d)"> <text>Dispose of special medical waste as set forth in COMAR 10.06.06.01—10.06.06.07.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Phlebotomist. A licensee shall ensure that an individual who collects blood specimens is trained in:</text> <paragraph num="(a)"> <text>Specimen collection methods; and</text> </paragraph> <paragraph num="(b)"> <text>Infection control and prevention techniques, including CDC recommendations for preventing the transmission of bloodborne pathogens in health care settings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Operator of an Analytical System: General. A licensee shall ensure that an operator of an analytical system is trained in:</text> <paragraph num="(a)"> <text>Infection control and prevention techniques, including CDC recommendations concerning the transmission of bloodborne pathogens in health care settings; and</text> </paragraph> <paragraph num="(b)"> <text>Proper use of the analytical system, including:</text> <paragraph num="(i)"> <text>Analytical system operation;</text> </paragraph> <paragraph num="(ii)"> <text>System methods used to process the specimen; and</text> </paragraph> <paragraph num="(iii)"> <text>Quality control techniques, procedures, and requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Operator of an Analytical System: Competency.</text> <paragraph num="(a)"> <text>Obtaining Personal Competency. Before an individual may operate an analytical system without direct supervision, the individual operator shall demonstrate competency in operating the analytical system by completing:</text> <paragraph num="(i)"> <text>Pre-field supervised practice that includes performing under direct supervision a minimum of ten tests of each applicable type of health awareness test; and</text> </paragraph> <paragraph num="(ii)"> <text>Field testing experience that includes individual performance of directly supervised testing in the field.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Documenting Training and Competency. The licensee shall document in writing that each analytical system operator has demonstrated competency as required under this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Control — Temporary and Mobile Laboratories: Event Registration."> <paragraph num="A."> <text>Primary Standard. In addition to meeting other applicable requirements set forth in this chapter, a licensee intending to perform a health awareness test at a temporary or mobile laboratory shall register the testing event with the Department before the testing event may occur.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>A licensee shall inform the OHCQ by phone or in writing of the date, time, location, and on-site supervisor's name for a testing event at least 14 days before the event is to take place.</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall display in a public place at the testing site and throughout the testing event a copy of the laboratory's license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Quality Control — Temporary and Mobile Laboratories: Cholesterol and Health Awareness."> <paragraph num="A."> <text>Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee offering to perform or performing cholesterol or health awareness testing at a temporary or mobile laboratory shall ensure that the laboratory:</text> <paragraph num="(1)"> <text>Develops and maintains a written SOPM;</text> </paragraph> <paragraph num="(2)"> <text>Validates the analyzer initially and utilizes the manufacturer’s reference range for the quality control with each new lot of quality control;</text> </paragraph> <paragraph num="(3)"> <text>Employs and maintains an in-field quality control program;</text> </paragraph> <paragraph num="(4)"> <text>Reports test results as set forth in §B(5) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Informs examinees of test limitations based on current nationally recognized standards for each test performed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Supervisor. A supervisor knowledgeable in all aspects of health awareness testing shall oversee all cholesterol or health awareness testing conducted at a temporary or mobile laboratory.</text> </paragraph> <paragraph num="(2)"> <text>SOPM.</text> <paragraph num="(a)"> <text>A licensee shall develop and maintain a written SOPM covering all current procedures for:</text> <paragraph num="(i)"> <text>Training personnel;</text> </paragraph> <paragraph num="(ii)"> <text>Analytical system maintenance;</text> </paragraph> <paragraph num="(iii)"> <text>Testing participants and quality control;</text> </paragraph> <paragraph num="(iv)"> <text>Retesting;</text> </paragraph> <paragraph num="(v)"> <text>Documenting lot numbers and expiration dates of quality control materials and reagents (cassettes) used for participant testing;</text> </paragraph> <paragraph num="(vi)"> <text>Evaluation of quality controls on site and documentation of corrective actions when quality control results are unacceptable;</text> </paragraph> <paragraph num="(vii)"> <text>An every 6 month evaluation of all analyzers used in Maryland using the worksheet provided by the Department; and</text> </paragraph> <paragraph num="(viii)"> <text>Other aspects of the cholesterol and health awareness testing service's activities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The general supervisor or director shall initially approve and when changes are made review, sign, and date the SOPM.</text> </paragraph> <paragraph num="(c)"> <text>All personnel shall have routine access to a copy of the SOPM at each testing site throughout each testing event.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Method Verification and Pre-Field Evaluation of an Analytical System. A licensee shall evaluate each analytical system by:</text> <paragraph num="(a)"> <text>Performing a method verification to demonstrate that the system produces test results within limits of accuracy and precision, as defined by either the licensee or the system's manufacturer, before the system may be used at a temporary or mobile laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Analyzing two levels of quality control materials.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In-field Quality Control. At a temporary or mobile laboratory, a licensee shall maintain a continuous quality control program in which:</text> <paragraph num="(a)"> <text>Each person who performs tests at a screening event shall test both levels of quality control samples identified in §B(3)(b) of this regulation on one analyzer for each cholesterol and health awareness test performed at the screening event;</text> </paragraph> <paragraph num="(b)"> <text>Quality control testing shall be performed on at least one analyzer, if more than one analyzer at a screening event is used;</text> </paragraph> <paragraph num="(c)"> <text>Each testing person shall test two levels of quality control materials on another analyzer at the beginning of the cholesterol or health awareness event if more than one person is performing tests at an event; and</text> </paragraph> <paragraph num="(d)"> <text>The laboratory shall complete the comparison worksheet designated by the Department quarterly to ensure that all the analyzers used for reporting test results produce results within 15 percent to 20 percent of the other analyzers.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Examinee results shall be reported above the established reportable range of the instrument, that is, analytic range, as greater than the highest reference point, with the analytic range being determined by pre-field testing.</text> </paragraph> <paragraph num="(6)"> <text>Reporting and Releasing Test Results.</text> <paragraph num="(a)"> <text>A licensee shall release cholesterol or health awareness test results only to the examinee or their physician in writing and in a manner to protect the confidentiality of the test results.</text> </paragraph> <paragraph num="(b)"> <text>A licensee shall include the following on its reports:</text> <paragraph num="(i)"> <text>The name, address, and phone number of the laboratory performing the test;</text> </paragraph> <paragraph num="(ii)"> <text>The date and location of the testing; and</text> </paragraph> <paragraph num="(iii)"> <text>The signature, initials, or electronic authentication of a laboratory employee.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A laboratory shall provide to an examinee a written explanation of all cholesterol and health awareness test results and refer the examinee for medical care when indicated by the results.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 18, 1985 (12:23 Md. R. 2217)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended effective September 16, 1991 (18:18 Md. R. 2005)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Physician Office and Other Point-of-Care Laboratories, repealed and new chapter, Medical Laboratories—Quality Assurance, adopted effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective July 24, 2000 (27:14 Md. R. 1340); January 13, 2011 (38:1 Md. R. 11)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B adopted effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective July 24, 2000 (27:14 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective July 24, 2000 (27:14 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective June 1, 2009 (36:11 Md. R. 787); April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective July 24, 2000 (27:14 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 repealed effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> </annotations> </chapter> <chapter num="07" heading="Medical Laboratories — Personnel"> <regulation prefix="Regulation" num=".01" heading="Permitted POL and POCL — Director and Associate Director."> <paragraph num="A."> <text>Primary Standard. The licensee of a permitted POL or POCL shall employ or otherwise engage the services of a qualified director or associate director and a laboratory supervisor or consulting supervisor.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Qualifications.</text> <paragraph num="(a)"> <text>POL. The director of a permitted POL shall be:</text> <paragraph num="(i)"> <text>A physician licensed by the Board of Physicians to practice medicine in the State and a member or employee of the practice operating the laboratory; or</text> </paragraph> <paragraph num="(ii)"> <text>An employee or contractor of the practice who possesses the training and experience set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>POCL. The director of a permitted POCL shall be:</text> <paragraph num="(i)"> <text>A physician of the medical care facility who possesses the applicable training and experience set forth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>An individual who qualifies as a director under 42 CFR §493.1443, and who possesses the applicable training and experience set forth in Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(iii)"> <text>An individual who meets the definition of a technologist as set forth in COMAR 10.10.01.03B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Duties and Responsibilities.</text> <paragraph num="(a)"> <text>A director of a permitted POL or POCL shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations to the extent necessary to ensure compliance with this chapter.</text> </paragraph> <paragraph num="(b)"> <text>A director's duties and responsibilities include:</text> <paragraph num="(i)"> <text>When applicable, employing or otherwise engaging the services of a qualified general supervisor or consulting supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>Ensuring that the general supervisor or consulting supervisor spends sufficient time performing the supervisory duties and responsibilities;</text> </paragraph> <paragraph num="(iii)"> <text>Completing and submitting to the OHCQ forms, supplied by the OHCQ, that document a general or consulting supervisor's education, training, and experience in laboratory practice;</text> </paragraph> <paragraph num="(iv)"> <text>Recruiting qualified and competent technical personnel;</text> </paragraph> <paragraph num="(v)"> <text>Obtaining or providing and documenting initial training and continuing education for technical personnel;</text> </paragraph> <paragraph num="(vi)"> <text>Reviewing with the laboratory supervisor or consulting supervisor all laboratory procedures and policies and all evaluative material, including proficiency testing results, pertinent to the operation and performance of the laboratory;</text> </paragraph> <paragraph num="(vii)"> <text>Serving as a liaison between the physicians of the practice or medical care facility and the laboratory supervisor or consulting supervisor and other technical personnel to communicate situations such as test interpretations, timeliness of reports, reporting abnormal test results, and new or changing laboratory procedures and policies affecting patient care;</text> </paragraph> <paragraph num="(viii)"> <text>Ensuring that all application forms, documents, and other materials required under this chapter are submitted to the OHCQ within the appropriate time periods; and</text> </paragraph> <paragraph num="(ix)"> <text>Designating an associate director, when applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Associate Director. An associate director shall:</text> <paragraph num="(a)"> <text>Meet the same qualifications as set forth in §B(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Act as laboratory director when the laboratory director is away from the laboratory for a period of more than 30 days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Supervisory Consultation. A director of a permitted POL or POCL shall:</text> <paragraph num="(a)"> <text>Consult with the laboratory supervisor in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Conduct an on-site visit to each directed laboratory at least once a month.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Director Limitation. A POL director may not serve as director or associate director, or both, of more than five medical laboratories at the same time.</text> </paragraph> <paragraph num="(6)"> <text>Changes in Employment or Service. A director shall notify the OHCQ within 30 days of any change in the director's service or employment as a laboratory director.</text> </paragraph> <paragraph num="(7)"> <text>Director Disqualification. A director or associate director may be disqualified to direct a permitted POL for failing to comply with the applicable standards and requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Permitted POL and POCL — General Supervisor and Consulting Supervisor."> <paragraph num="A."> <text>Primary Standard. A licensee operating a POL or POCL under a permit shall employ or otherwise engage a qualified general supervisor or consulting supervisor.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Requirement. A laboratory shall employ or otherwise engage a qualified general supervisor or consulting supervisor who shall act in concert with the laboratory director to ensure that the laboratory complies with the standards and requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Qualifications — POL and POCL General Supervisor. To qualify as a laboratory supervisor in a permitted POL or POCL, an individual shall be a:</text> <paragraph num="(a)"> <text>Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised;</text> </paragraph> <paragraph num="(b)"> <text>Technologist as defined in COMAR 10.10.01.03B and employed to perform tests at least 1 day a week in the lab being supervised; or</text> </paragraph> <paragraph num="(c)"> <text>Technician as defined in COMAR 10.10.01.03B and employed to perform tests on a full-time basis in the lab being supervised.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Qualifications — Consulting Supervisor. To qualify as a consulting supervisor of a POL or POCL, an individual shall be a:</text> <paragraph num="(a)"> <text>Technologist as defined in COMAR 10.10.01.03B who possesses at least 2 years of work experience in a laboratory that:</text> <paragraph num="(i)"> <text>Operated under a permit; and</text> </paragraph> <paragraph num="(ii)"> <text>Performed testing services related to those offered by the laboratory to be supervised; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Supervisory Duties and Responsibilities. A general supervisor or consulting supervisor shall:</text> <paragraph num="(a)"> <text>Implement and maintain the applicable laboratory standards and requirements set forth in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Ensure proper and reliable test performance, reporting, record keeping, and immediate general and technical supervision of testing personnel and laboratory services;</text> </paragraph> <paragraph num="(c)"> <text>Develop, implement, and oversee maintenance of an internal quality assurance program that includes:</text> <paragraph num="(i)"> <text>A working quality control program or system that determines and documents accuracy and precision of all tests performed;</text> </paragraph> <paragraph num="(ii)"> <text>Selection and use of quality control and standard materials for analysis;</text> </paragraph> <paragraph num="(iii)"> <text>Recording and documenting quality control data;</text> </paragraph> <paragraph num="(iv)"> <text>Ongoing analysis of quality control data; and</text> </paragraph> <paragraph num="(v)"> <text>Implementation and maintenance of a specimen documentation and management system;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Prepare and maintain a SOPM;</text> </paragraph> <paragraph num="(e)"> <text>Ensure full participation in an external proficiency testing program approved by the Secretary as set forth in COMAR 10.10.05.03;</text> </paragraph> <paragraph num="(f)"> <text>Teach proper laboratory techniques, including the importance of quality control, quality assurance, and proficiency testing;</text> </paragraph> <paragraph num="(g)"> <text>Review proficiency testing results, determine sources of error, and work to correct any problems;</text> </paragraph> <paragraph num="(h)"> <text>Review proficiency testing results, analytical studies and evaluations, and survey reports with technical personnel to improve test performance and laboratory services;</text> </paragraph> <paragraph num="(i)"> <text>Maintain, as part of laboratory records, a log or other suitable record documenting monthly consultations with the director and all supervisory activities provided to the laboratory;</text> </paragraph> <paragraph num="(j)"> <text>Ensure that laboratory testing personnel:</text> <paragraph num="(i)"> <text>Possess the education, training, and experience required to perform and report laboratory test results accurately and promptly;</text> </paragraph> <paragraph num="(ii)"> <text>Are sufficient in number for the scope and complexity of the services provided;</text> </paragraph> <paragraph num="(iii)"> <text>Receive regular in-service training and continuing education appropriate for the scope and complexity of the services provided; and</text> </paragraph> <paragraph num="(iv)"> <text>Maintain competency in performing test procedures and reporting test results; and</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Perform other duties and responsibilities as delegated and authorized by the director that may include assisting in:</text> <paragraph num="(i)"> <text>Developing cost benefit data;</text> </paragraph> <paragraph num="(ii)"> <text>Identifying and recommending adjustments to a laboratory's scope of services; and</text> </paragraph> <paragraph num="(iii)"> <text>Recommending the purchase or replacement of test kits, reagents, and equipment.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permitted POL and POCL — Consulting Supervisor Services."> <paragraph num="A."> <text>General.</text> <paragraph num="(1)"> <text>A licensee operating a permitted POL or POCL who does not employ or otherwise engage technical personnel who qualify as a general supervisor shall arrange with a qualified consulting supervisor to provide technical and general supervisory consultation services in laboratory practice.</text> </paragraph> <paragraph num="(2)"> <text>The licensee operating a POL or POCL under a permit shall use a consulting supervisor who:</text> <paragraph num="(a)"> <text>Makes and documents on-site visits to each laboratory facility at least twice each calendar year;</text> </paragraph> <paragraph num="(b)"> <text>Is available by telephone during the laboratory's regular operating hours; and</text> </paragraph> <paragraph num="(c)"> <text>Completes a laboratory inspection checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once every 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Visits. The OHCQ may require more than two on-site visits per year by a consulting supervisor when:</text> <paragraph num="(1)"> <text>A laboratory exhibits unsatisfactory proficiency testing performance;</text> </paragraph> <paragraph num="(2)"> <text>An on-site survey by the OHCQ shows that:</text> <paragraph num="(a)"> <text>A laboratory is not in substantial compliance with the applicable standards and requirements of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>A laboratory's written plan of correction in response to a Department survey does not ensure substantial compliance with the applicable standards and requirements of this chapter; or</text> </paragraph> <paragraph num="(c)"> <text>A laboratory's testing personnel require additional supervisory consultations to obtain or maintain proficiency in quality assurance, performing or reporting test results, or meeting other applicable standards of this chapter;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An inspection checklist submitted by the laboratory shows that the laboratory is operating in a manner that is not in compliance with applicable standards of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>The laboratory's general supervisor or consulting supervisor has been unable to perform the duties and responsibilities set forth in Regulation .02B(4) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Permitted Laboratory Other than a POL or POCL — Director."> <paragraph num="A."> <text>Primary Standard. A licensee operating a permitted laboratory other than a POL or POCL shall employ a director who meets the applicable qualifications, responsibilities, and standards set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Qualifications. In addition to applicable personnel standards set forth in this chapter, a director shall meet the applicable standards set forth in 42 CFR §493.1443.</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities. A director shall carry out the applicable responsibilities set forth in 42 CFR §§493.1407 and 493.1445.</text> </paragraph> <paragraph num="(3)"> <text>Associate Director. A director shall designate another individual who qualifies as a director under this chapter to serve as an associate or substitute director when the director:</text> <paragraph num="(a)"> <text>Will be away from the laboratory for a period of more than 30 days; or</text> </paragraph> <paragraph num="(b)"> <text>Is unable to carry out the responsibilities set forth in §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Communications. A director shall communicate with the laboratory's supervisory personnel in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory.</text> </paragraph> <paragraph num="(5)"> <text>On-site Visits. A director of a laboratory shall conduct an on-site visit of the laboratory at least once a month.</text> </paragraph> <paragraph num="(6)"> <text>Limitation. The director of a permitted laboratory may not serve as director or associate director, or both, of more than five medical laboratories at the same time.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Permitted Laboratories — Technical Supervisors."> <paragraph num="A."> <text>Primary Standards.</text> <paragraph num="(1)"> <text>A laboratory director certified, or eligible for certification, in anatomic and clinical pathology by the American Board of Pathology qualifies as a technical supervisor in all disciplines and subdisciplines set forth in COMAR 10.10.01.03B, except:</text> <paragraph num="(a)"> <text>Genetics; and</text> </paragraph> <paragraph num="(b)"> <text>Forensic toxicology.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee who does not employ or otherwise engage a director certified in anatomic and clinical pathology by the American Board of Pathology, or a licensee operating a laboratory that performs testing in the discipline of genetics or forensic toxicology shall employ the services of a technical supervisor for each discipline set forth in COMAR 10.10.01.03B except the discipline of health awareness testing.</text> </paragraph> <paragraph num="(3)"> <text>A technical supervisor shall carry out the applicable responsibilities set forth in 42 CFR §493.1451.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standards.</text> <paragraph num="(1)"> <text>Requirement. A licensee operating a laboratory that performs testing in one or more disciplines shall employ a director or technical supervisor who meets the qualifications for a technical supervisor in the applicable disciplines or subdisciplines set forth in §B(2)—(13) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Chemistry. A technical supervisor shall possess a bachelor's or higher degree including significant studies in chemistry and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical chemistry.</text> </paragraph> <paragraph num="(3)"> <text>Gynecologic Cytology. A technical supervisor shall meet the requirements set forth in 42 CFR §493.1449.</text> </paragraph> <paragraph num="(4)"> <text>Dermatopathology. A technical supervisor shall be:</text> <paragraph num="(a)"> <text>A physician licensed by the Board of Physicians to practice medicine in the State; and</text> </paragraph> <paragraph num="(b)"> <text>Either certified or eligible for certification in dermatopathology or anatomic pathology by the:</text> <paragraph num="(i)"> <text>American Board of Dermatology;</text> </paragraph> <paragraph num="(ii)"> <text>American Osteopathic Board of Dermatology;</text> </paragraph> <paragraph num="(iii)"> <text>American Board of Pathology; or</text> </paragraph> <paragraph num="(iv)"> <text>American Osteopathic Board of Pathology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Forensic Toxicology — General Qualifications. A technical supervisor shall:</text> <paragraph num="(a)"> <text>Be certified in toxicological chemistry by the American Board of Clinical Chemistry;</text> </paragraph> <paragraph num="(b)"> <text>Be certified in forensic toxicology by the American Board of Forensic Toxicology;</text> </paragraph> <paragraph num="(c)"> <text>Be certified in clinical pathology and chemistry by the American Board of Pathology; or</text> </paragraph> <paragraph num="(d)"> <text>Possess education and experience in toxicology equivalent to that required by one of these boards.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Forensic Toxicology — Alternative Qualifications. An individual who does not qualify as a technical supervisor under §B(5) of this regulation may qualify as a technical supervisor if the individual:</text> <paragraph num="(a)"> <text>Can document training or experience, or both, in the:</text> <paragraph num="(i)"> <text>Analysis of biological material for alcohol or controlled dangerous substances, or both; and</text> </paragraph> <paragraph num="(ii)"> <text>Forensic applications of analytical toxicology, such as court testimony, use of chain of custody, and specimen security; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Possesses:</text> <paragraph num="(i)"> <text>A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians, with certification in clinical pathology or forensic pathology, and have at least 2 years of laboratory experience in analytical toxicology;</text> </paragraph> <paragraph num="(ii)"> <text>A doctoral degree in a biological, chemical, pharmacological, or toxicological discipline and have at least 2 years of laboratory experience in analytical toxicology; or</text> </paragraph> <paragraph num="(iii)"> <text>A master's degree in a biological, chemical, pharmacological, or toxicological discipline with at least 6 years of experience in analytical toxicology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Genetics. A technical supervisor of biochemical genetics, cytogenetics, or molecular genetics shall possess:</text> <paragraph num="(a)"> <text>A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians; or</text> </paragraph> <paragraph num="(b)"> <text>An earned doctorate in one of the biological or chemical sciences from an accredited institution with:</text> <paragraph num="(i)"> <text>4 years of laboratory experience in genetics; or</text> </paragraph> <paragraph num="(ii)"> <text>Eligibility for certification by the American Board of Medical Genetics.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Hematology. A technical supervisor shall possess a baccalaureate or higher degree including studies in biology or general cytology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in hematology.</text> </paragraph> <paragraph num="(9)"> <text>Immunology. A technical supervisor shall possess a baccalaureate or higher degree including studies in immunology, microbiology, or chemistry and have at least 4 years post-baccalaureate or 2 years post-master's experience in immunology-serology.</text> </paragraph> <paragraph num="(10)"> <text>Microbiology. A technical supervisor shall possess a baccalaureate or higher degree including studies in microbiology or immunology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical microbiology.</text> </paragraph> <paragraph num="(11)"> <text>Molecular Biology. A technical supervisor shall possess a baccalaureate or higher degree including studies in molecular biology and have at least 4 years post-baccalaureate or 2 years post-master's experience in molecular biology, microbiology, immunology, or clinical chemistry.</text> </paragraph> <paragraph num="(12)"> <text>Oral Pathology, Including Oral Cytopathology. A technical supervisor shall be a dentist or physician licensed to practice in Maryland and be certified or eligible for certification by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology.</text> </paragraph> <paragraph num="(13)"> <text>Tissue Pathology. A technical supervisor shall be a physician licensed to practice medicine in Maryland and be certified or eligible for certification in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Permitted Laboratory Other than a POL or POCL — Supervisors."> <paragraph num="A."> <text>Primary Standard. A licensee operating a laboratory other than a POL or POCL shall employ a qualified supervisory technologist or general supervisor, who in the absence of the director or technical supervisor is responsible for the proper performance of laboratory procedures and reporting of laboratory test results.</text> </paragraph> <paragraph num="B."> <text>Standards: General Supervisor.</text> <paragraph num="(1)"> <text>Personnel Qualifications. A general supervisor shall be a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than a laboratory operating under a letter of exception.</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Standards: Supervisory Cytotechnologist.</text> <paragraph num="(1)"> <text>Personnel Qualifications. For the specialty of cytology, a laboratory shall employ the services of a supervisory cytotechnologist who meets the qualifications set forth in 42 CFR §493.1469.</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities. A supervisory cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1471.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Standards: Supervisor of Blood Gas Analyses. An individual qualifies as a supervisor of blood gas analyses by:</text> <paragraph num="(1)"> <text>Possessing an earned doctoral, master's, or baccalaureate degree in respiratory care or cardiovascular technology; and</text> </paragraph> <paragraph num="(2)"> <text>Meeting the personnel qualifications set forth in 42 CFR §493.1449.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Permitted Laboratory Other than POL or POCL — Testing Personnel."> <paragraph num="A."> <text>Primary Standard. A permitted laboratory other than a POL or POCL shall employ or engage testing personnel, sufficient in number to perform testing for the volume and complexity of testing performed, who meet the qualifications and carry out the responsibilities set forth in this regulation.</text> </paragraph> <paragraph num="B."> <text>Standards — General.</text> <paragraph num="(1)"> <text>Personnel Qualifications. An individual performing one or more laboratory tests shall meet the applicable qualifications set forth in 42 CFR §493.1423.</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities. Testing personnel shall carry out the responsibilities set forth in 42 CFR §493.1425.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Standards — Cytotechnologist.</text> <paragraph num="(1)"> <text>Personnel Qualifications. For the specialty of cytology, a licensee shall employ the services of cytotechnologists who meet the qualifications set forth in 42 CFR §§493.1483.</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities. A cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1485.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Standards — Blood Gas Analysis — Personnel Qualifications. Personnel performing blood gas analyses shall:</text> <paragraph num="(1)"> <text>Meet the standards set forth in 42 CFR §493.1489; or</text> </paragraph> <paragraph num="(2)"> <text>Complete a 1-year certificate program in respiratory care.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-202, 17-203, 17-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective March 1, 2026 (52:24 Md. R. 1198)</annotation> </annotations> </chapter> <chapter num="08" heading="Medical Laboratories — Sanctions"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>Authority and Types.</text> <paragraph num="(1)"> <text>The Secretary may impose one or more principal or alternative sanctions.</text> </paragraph> <paragraph num="(2)"> <text>Principal Sanctions. The Secretary may impose the following principal sanctions:</text> <paragraph num="(a)"> <text>Denial of a license;</text> </paragraph> <paragraph num="(b)"> <text>Suspension of a license; and</text> </paragraph> <paragraph num="(c)"> <text>Revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Alternative Sanctions. Instead of or in conjunction with lifting a principal sanction, the Secretary may impose one or more of the following alternative sanctions:</text> <paragraph num="(a)"> <text>A directed plan of correction;</text> </paragraph> <paragraph num="(b)"> <text>Limitation on testing; and</text> </paragraph> <paragraph num="(c)"> <text>Training and technical assistance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Reasons for Imposition. A laboratory is subject to the imposition of one or more sanctions when the OHCQ finds:</text> <paragraph num="(1)"> <text>A deficiency identified through an on-site survey or a review of materials submitted by a laboratory, such as applications data, personnel qualification materials, and self-inspection checklists;</text> </paragraph> <paragraph num="(2)"> <text>Unsuccessful proficiency testing performance;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrated incompetence, such as showing consistent or repetitive errors in operating equipment or in performing a test or procedure;</text> </paragraph> <paragraph num="(4)"> <text>False statements made on an application, plan-of-correction, or other form submitted to the OHCQ;</text> </paragraph> <paragraph num="(5)"> <text>Misrepresentation in obtaining a permit or letter of exception or in operating a laboratory;</text> </paragraph> <paragraph num="(6)"> <text>Failure to comply with the:</text> <paragraph num="(a)"> <text>Cancer reporting requirements of Health-General Article, §18-204, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Infectious disease and submission of clinical material requirements of Health-General Article, §18-205, Annotated Code of Maryland, and COMAR 10.06.01;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Submission of a specimen by a laboratory inside the State to another laboratory that does not possess a license as set forth in COMAR 10.10.03;</text> </paragraph> <paragraph num="(8)"> <text>Conviction by a court of a violation of the laws of the State pertaining to a medical laboratory; or</text> </paragraph> <paragraph num="(9)"> <text>Exceeding the 50 test per year limit when operating under a letter of exception—limited testing for rare diseases as set forth in COMAR 10.10.03.05B.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a laboratory based on, but not limited to, the following:</text> <paragraph num="(1)"> <text>Whether a deficiency poses immediate jeopardy to personal or public health or safety;</text> </paragraph> <paragraph num="(2)"> <text>The nature, incidence, severity, and duration of the deficiency;</text> </paragraph> <paragraph num="(3)"> <text>Whether a deficiency has been identified repeatedly;</text> </paragraph> <paragraph num="(4)"> <text>The inaccuracy or extent of missing laboratory records, such as missing documentation of remedial action or failure to make records available to the OHCQ;</text> </paragraph> <paragraph num="(5)"> <text>The relationship of one deficiency or group of deficiencies to another deficiency;</text> </paragraph> <paragraph num="(6)"> <text>The overall compliance history of a laboratory, including but not limited to any period of noncompliance that occurred between determinations of compliance;</text> </paragraph> <paragraph num="(7)"> <text>The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and</text> </paragraph> <paragraph num="(8)"> <text>The progress a laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Mandatory Revocation of a License. The Secretary shall revoke for 1 year the license of a laboratory that intentionally refers a proficiency test sample to another laboratory for analysis.</text> </paragraph> <paragraph num="E."> <text>Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a laboratory that has had its license revoked may not, within 1 year of the revocation, apply for a license, or own or operate a laboratory for which a license has been issued under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Departmental Actions — General."> <paragraph num="A."> <text>Deficiency Posing Immediate Jeopardy.</text> <paragraph num="(1)"> <text>If a laboratory's deficiency poses immediate jeopardy to personal or public health or safety, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall:</text> <paragraph num="(a)"> <text>Require the laboratory to take immediate action to remove the jeopardy; and</text> </paragraph> <paragraph num="(b)"> <text>Impose:</text> <paragraph num="(i)"> <text>A principal sanction after giving the laboratory at least 24 hours notice; or</text> </paragraph> <paragraph num="(ii)"> <text>One or more alternative sanctions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Follow-up Actions. If the OHCQ finds in a follow-up survey of a laboratory under an alternative sanction that the laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the laboratory at least 24 hours notice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Deficiency Not Posing Immediate Jeopardy.</text> <paragraph num="(1)"> <text>If a laboratory's deficiency does not pose immediate jeopardy to personal or public health or safety, the Secretary may take one or more of the actions listed in §B(2) — (4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction.</text> </paragraph> <paragraph num="(3)"> <text>Unsatisfactory Proficiency Testing. If a laboratory exhibits unsatisfactory proficiency testing performance, as set forth in COMAR 10.10.01.03B, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction.</text> </paragraph> <paragraph num="(4)"> <text>Follow-up Actions. If the OHCQ finds in a follow-up survey that a laboratory has not corrected a deficiency within 30 days after it was identified, the Secretary may:</text> <paragraph num="(a)"> <text>Impose, or continue if already imposed, one or more sanctions;</text> </paragraph> <paragraph num="(b)"> <text>Conduct one or more on-site visits to evaluate progress in correcting a deficiency; and</text> </paragraph> <paragraph num="(c)"> <text>Conduct an additional follow-up survey to determine whether all corrections have been made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Duration of a Sanction. A sanction shall remain in force until:</text> <paragraph num="(1)"> <text>A laboratory corrects the deficiency; or</text> </paragraph> <paragraph num="(2)"> <text>A laboratory's license is revoked.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Lifting of a Sanction.</text> <paragraph num="(1)"> <text>General Rule. The Secretary may not lift a sanction until regulatory compliance is verified.</text> </paragraph> <paragraph num="(2)"> <text>Credible Allegation of Compliance. When a sanctioned laboratory submits a credible allegation of compliance, the Secretary shall:</text> <paragraph num="(a)"> <text>Determine compliance on the basis of the evidence submitted by the laboratory in its allegation;</text> </paragraph> <paragraph num="(b)"> <text>Conduct a follow-up survey to verify whether the laboratory has achieved compliance; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(2)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Departmental Actions — Principal Sanctions."> <paragraph num="A."> <text>Hearing Requirement.</text> <paragraph num="(1)"> <text>Except when the Secretary finds that a danger to public health or safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing when a suspension or revocation of the licensee's license takes effect, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>When a finding is made that the public health or safety imperatively requires that emergency or immediate action be taken, the Secretary shall inform the licensee in writing of a suspension or revocation of the licensee's license, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, after the suspension or revocation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notice.</text> <paragraph num="(1)"> <text>Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the:</text> <paragraph num="(a)"> <text>Deficiency identified;</text> </paragraph> <paragraph num="(b)"> <text>Sanction proposed for imposition;</text> </paragraph> <paragraph num="(c)"> <text>Reason for the proposed sanction;</text> </paragraph> <paragraph num="(d)"> <text>Projected effective date and duration of the proposed sanction;</text> </paragraph> <paragraph num="(e)"> <text>Authority for the proposed sanction; and</text> </paragraph> <paragraph num="(f)"> <text>Time allowed for a laboratory to respond to the notice.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Opportunity to Respond. During the time allowed and stated in the written notice, a laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions.</text> </paragraph> <paragraph num="(3)"> <text>Notice Times.</text> <paragraph num="(a)"> <text>If a deficiency is found imperatively to require emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of sanction.</text> </paragraph> <paragraph num="(b)"> <text>If a deficiency is found to warrant a principal sanction but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction.</text> </paragraph> <paragraph num="(c)"> <text>To preserve its right to a hearing, a licensee shall request a hearing within 10 days of its receipt of the notice of the pending sanction.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Enforcement Procedures — Proficiency Testing."> <paragraph num="A."> <text>Application. If a laboratory's performance in proficiency testing is unsuccessful or unsatisfactory, as set forth in COMAR 10.10.05, the Secretary may require the laboratory to undertake the directed plan of correction of the training of its personnel or the obtaining of necessary technical assistance, or both, in order to meet the proficiency testing requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Procedures. A laboratory required to undertake training of personnel or to obtain necessary technical assistance shall:</text> <paragraph num="(1)"> <text>Document the training or assistance, or both, using forms provided by the OHCQ; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the completed forms to the OHCQ.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Departmental Action — Reporting Erroneous or Questionable Patient Test Results."> <paragraph num="A."> <text>If the Department determines that a licensee has reported an erroneous or questionable patient test result that threatens the health or safety of the patient, the Secretary may order the licensee, within a specified period of time, to:</text> <paragraph num="(1)"> <text>Give prompt notice of the erroneous or questionable patient test result to the:</text> <paragraph num="(a)"> <text>Person who requested that the test be performed; and</text> </paragraph> <paragraph num="(b)"> <text>Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide corrected reports to the persons notified in §A(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Maintain duplicates of both the original report and the corrected report;</text> </paragraph> <paragraph num="(4)"> <text>Conduct a quality assessment of all phases of the testing process to:</text> <paragraph num="(a)"> <text>Determine the cause of the erroneous or questionable test result; and</text> </paragraph> <paragraph num="(b)"> <text>Take the necessary remedial or corrective action to prevent recurrence of the problem; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:</text> <paragraph num="(a)"> <text>Notifying the:</text> <paragraph num="(i)"> <text>Patient;</text> </paragraph> <paragraph num="(ii)"> <text>Community at large if the Secretary determines that the licensee's laboratory operation is a threat to patient health and safety; and</text> </paragraph> <paragraph num="(iii)"> <text>If the licensee is unable to notify a patient, the Department; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Retesting:</text> <paragraph num="(i)"> <text>The same specimen;</text> </paragraph> <paragraph num="(ii)"> <text>A new specimen; or</text> </paragraph> <paragraph num="(iii)"> <text>Both the same specimen and a new specimen.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Civil Penalty for Failure to Comply with Order.</text> <paragraph num="(1)"> <text>A laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary may impose the civil penalty instead of or in addition to any other sanction imposed under this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice and Hearing.</text> <paragraph num="(1)"> <text>Notice. Before the Secretary imposes a civil penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to the licensee:</text> <paragraph num="(a)"> <text>Of the intent to impose a civil money penalty; and</text> </paragraph> <paragraph num="(b)"> <text>That the licensee has an opportunity for a hearing on the matter before the civil penalty is imposed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Content. The Secretary shall give written notice to the licensee of the:</text> <paragraph num="(a)"> <text>Reason for the imposition of the civil penalty;</text> </paragraph> <paragraph num="(b)"> <text>Amount of the civil penalty;</text> </paragraph> <paragraph num="(c)"> <text>Effective date of the imposition of the civil penalty;</text> </paragraph> <paragraph num="(d)"> <text>Time allowed for the licensee to respond to the notice; and</text> </paragraph> <paragraph num="(e)"> <text>Authority for imposing the civil penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this regulation or Health-General Article, §17-210, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary's intent to impose the civil penalty.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil penalty is appropriate, the Secretary shall take into consideration the following factors in determining the amount of the penalty:</text> <paragraph num="(1)"> <text>The extent to which the licensee derived any financial benefit from reporting erroneous or questionable patient test results;</text> </paragraph> <paragraph num="(2)"> <text>The willfulness on the part of the licensee;</text> </paragraph> <paragraph num="(3)"> <text>The extent of actual or potential public harm caused by reporting erroneous or questionable patient test results;</text> </paragraph> <paragraph num="(4)"> <text>The cost of investigating and prosecuting the case against the licensee;</text> </paragraph> <paragraph num="(5)"> <text>The licensee's history of previous failure to meet the standards of this subtitle; and</text> </paragraph> <paragraph num="(6)"> <text>The existence of mitigating factors.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment of Penalties.</text> <paragraph num="(1)"> <text>At the Secretary's discretion, the Secretary may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="(2)"> <text>All monies collected by the Secretary pursuant to this regulation shall be paid into the General Fund of the State.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-202, 17-206, 17-210, 17-211, and 17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective March 27, 2006 (33:6 Md. R. 578)</annotation> </annotations> </chapter> <chapter num="09" heading="Forensic Laboratories — Personnel Certification and Approval of Laboratory Procedures"> <regulation prefix="Regulation" num=".01" heading="Qualifications."> <paragraph num="A."> <text>Certified Chemist and Certified Chemical Analyst. An applicant for certified chemist or certified chemical analyst shall:</text> <paragraph num="(1)"> <text>Hold a bachelor's degree from an accredited college or university with a major in chemistry, medical technology, biology, physics, pharmacy, pharmacology, or forensic science;</text> </paragraph> <paragraph num="(2)"> <text>Have completed courses in analytical and organic chemistry; and</text> </paragraph> <paragraph num="(3)"> <text>Have completed a basic training program for certified chemist or certified chemical analyst as set forth in Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Certified Analyst. An applicant for certified analyst shall:</text> <paragraph num="(1)"> <text>Possess a high school diploma or its equivalent;</text> </paragraph> <paragraph num="(2)"> <text>Have completed a basic training program for certified analyst as set forth in Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Identify in the application those specific drug-testing procedures for which certification is being sought and for which training has been received.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Approved Training Programs for Chemists, Chemical Analysts, and Analysts."> <paragraph num="A."> <text>Certified Chemist.</text> <paragraph num="(1)"> <text>An applicant for certification as a certified chemist shall have successfully completed:</text> <paragraph num="(a)"> <text>The basic training program for forensic drug chemists offered by the United States Department of Justice, Drug Enforcement Administration; or</text> </paragraph> <paragraph num="(b)"> <text>A training program in the discipline of controlled dangerous substances provided by a forensic laboratory licensed by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The applicant shall demonstrate completion of the training program referenced in §A(1)(b) of this regulation by providing the Department with the forensic laboratory director’s written authorization for that individual to perform casework independently in the discipline of controlled dangerous substances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Certified Chemical Analyst. An applicant for certification as a certified chemical analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under Regulation .04 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Certified Analyst. An applicant for certification as a certified analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, using procedures approved under Regulation .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Employment, Employment Certification, and Automatic Decertification."> <paragraph num="A."> <text>Employment. An individual applying for certification under this chapter shall be currently employed by:</text> <paragraph num="(1)"> <text>The Department;</text> </paragraph> <paragraph num="(2)"> <text>The Maryland State Police;</text> </paragraph> <paragraph num="(3)"> <text>The Baltimore City Police Department;</text> </paragraph> <paragraph num="(4)"> <text>The police department or a municipality or county in this State; or</text> </paragraph> <paragraph num="(5)"> <text>A private forensic laboratory licensed by the Maryland Department of Health that has a contract with a Maryland law enforcement agency to provide testing services for controlled dangerous substances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Employment Certification. An applicant's supervisor shall certify that the applicant is currently employed by an agency listed in §A of this regulation by signing the employment certification section of the application.</text> </paragraph> <paragraph num="C."> <text>Certification and Automatic Decertification.</text> <paragraph num="(1)"> <text>Certification under this chapter is only valid when the individual is employed by an agency listed in §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An individual certified under this chapter is automatically decertified when the individual:</text> <paragraph num="(a)"> <text>Is no longer employed by the agency that certified employment;</text> </paragraph> <paragraph num="(b)"> <text>Retires from the agency that certified employment; or</text> </paragraph> <paragraph num="(c)"> <text>Changes employment from one agency listed in §A of this regulation to another agency listed in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual shall reapply for certification under this chapter if the individual is:</text> <paragraph num="(a)"> <text>Rehired by the same agency that previously certified employment; or</text> </paragraph> <paragraph num="(b)"> <text>Hired by a different agency listed in §A of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedures."> <text>Chemists, chemical analysts, and analysts certified under this chapter are certified only when performing those drug identification procedures:</text> <paragraph num="A."> <text>Approved by a forensic laboratory licensed by the Department; or</text> </paragraph> <paragraph num="B."> <text>Contained in the “Forensic Chemists and Analysts Training and Procedures Manual” 1992, which is incorporated by reference.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Report."> <text>A report prepared pursuant to these regulations shall contain the following information:</text> <paragraph num="A."> <text>The signature of the certified chemist, chemical analyst, or analyst performing the drug-identification procedure;</text> </paragraph> <paragraph num="B."> <text>The name of the person who delivered the material to be tested to the certified chemist, chemical analyst, or analyst;</text> </paragraph> <paragraph num="C."> <text>A statement that the chemist, chemical analyst, or analyst has been certified by the Department to perform the procedures identified in the report;</text> </paragraph> <paragraph num="D."> <text>A statement by the certified chemist, chemical analyst, or analyst that the results contained in the report were reached using procedures approved by the Department;</text> </paragraph> <paragraph num="E."> <text>A statement by the certified chemist, chemical analyst, or analyst concerning whether the material tested is, or contains, the drug identified in the report; and</text> </paragraph> <paragraph num="F."> <text>A statement by the certified chemist, chemical analyst, or analyst that quality control of the drug-identification procedures was performed to ensure the reliability of the procedures performed.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §17-2A-02; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 11, 1985 (12:5 Md. R. 483)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective August 6, 1990 (17:15 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .04 repealed, new Regulations .03—.06 adopted effective August 6, 1990 (17:15 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 recodified as Regulation .07 effective August 6, 1990 (17:15 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 1, 1993 (20:4 Md. R. 371)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.10.03 and revised effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective November 11, 2013 (40:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 23, 2002 (29:25 Md. R. 1982); November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective September 10, 2019 (46:20 Md. R. 842); adopted permanently effective December 30, 2019 (46:26 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1982); November 11, 2013 (40:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> </annotations> </chapter> <chapter num="10" heading="Job-Related Alcohol and Controlled Dangerous Substances Testing"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter provides for the protection of employers, employees, and the public by setting fair and effective job-related alcohol and controlled dangerous substances testing standards to ensure accurate and reliable test results and to promote drug-free workplaces.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter provides the standards and procedures that employers, employees, and the Secretary shall meet when job applicants and employees are required to undergo job-related alcohol and controlled dangerous substances testing.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>A person who is subject to federal or State commercial motor vehicle statutes or regulations concerning alcohol and controlled dangerous substances testing, to the extent that those statutes or regulations conflict with the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>An agency of the federal government;</text> </paragraph> <paragraph num="(3)"> <text>Alcohol or controlled dangerous substances testing of an individual under arrest or held by a law enforcement or correctional agency;</text> </paragraph> <paragraph num="(4)"> <text>Alcohol testing conducted by a law enforcement or correctional agency on breath-testing equipment certified by the State toxicologist; or</text> </paragraph> <paragraph num="(5)"> <text>Controlled dangerous substances testing by a laboratory facility of a law enforcement or correctional agency that maintains laboratory testing standards comparable to the standards in Health-General Article, §17-214, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Agent of the employer” means a person other than the employer or a licensed medical laboratory that employs individuals who perform preliminary screening of job applicants for controlled dangerous substances on behalf of the employer.</text> </paragraph> <paragraph num="(2)"> <text>“Chain-of-custody” means a method of tracking an individual's specimen for the purpose of maintaining control and accountability from initial collection through each stage in handling, testing, storing, reporting test results, and final specimen disposition.</text> </paragraph> <paragraph num="(3)"> <text>Confirmation Test.</text> <paragraph num="(a)"> <text>“Confirmation test” means an analytical procedure performed after a preliminary or screening test and intended to verify or positively identify the presence of a controlled dangerous substance in a specimen.</text> </paragraph> <paragraph num="(b)"> <text>“Confirmation test” is limited to an analytical procedure that employs a combination of gas chromatography and mass spectrometry (GC/MS or GC/MS/MS) or mass spectrometry and mass spectrometry (MS/MS).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Controlled Dangerous Substance.</text> <paragraph num="(a)"> <text>“Controlled dangerous substance” means a drug, substance, or immediate precursor as set forth in Schedules I—V, Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Controlled dangerous substance” includes new substances controlled under federal law as provided in Criminal Law Article, §5-202, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Employee.</text> <paragraph num="(a)"> <text>“Employee” means an individual who performs work for an employer.</text> </paragraph> <paragraph num="(b)"> <text>“Employee” includes a salaried, contractual, full-time, part-time, temporary, hourly, and on-call employee or a volunteer.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Employer” means a person who employs an individual to perform work.</text> </paragraph> <paragraph num="(7)"> <text>“Forensic testing” means testing performed for a nonclinical purpose and under procedures that produce test results that meet rules of evidence required in a court of law.</text> </paragraph> <paragraph num="(8)"> <text>“Immediate precursor” means a substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Independent test” means a test performed at the request and expense of a job applicant, employee, or contractor to verify a test result obtained on the same specimen.</text> </paragraph> <paragraph num="(10)"> <text>“Job applicant” means an individual who has applied for a position with an employer but is not currently employed by the employer.</text> </paragraph> <paragraph num="(11)"> <text>“Job-related testing” means any alcohol or controlled dangerous substances testing used by an employer for a lawful business purpose.</text> </paragraph> <paragraph num="(12)"> <text>Laboratory.</text> <paragraph num="(a)"> <text>“Laboratory” means a facility, entity, or site that performs job-related alcohol or controlled dangerous substances testing.</text> </paragraph> <paragraph num="(b)"> <text>“Laboratory” does not include a collection site or other site where an employer or agent of the employer performs preliminary screening of job applicants for a controlled dangerous substance using a single-use test device for forensic testing.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Letter of registration” means the authority in the form of a letter issued by the Secretary granting permission to an employer to perform preliminary screening of job applicants for a controlled dangerous substance.</text> </paragraph> <paragraph num="(14)"> <text>“License” means the authority in the form of a permit issued by the Secretary granting permission for a laboratory to perform job-related alcohol or controlled dangerous substances testing.</text> </paragraph> <paragraph num="(15)"> <text>“Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing who is either employed or under contract to an employer that performs preliminary screening of job applicants for a controlled dangerous substance.</text> </paragraph> <paragraph num="(16)"> <text>“Non-negative test result” means the result of a preliminary screening for a controlled dangerous substance that is not negative but that has not been confirmed by a licensed laboratory.</text> </paragraph> <paragraph num="(17)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(18)"> <text>“Operator” means an individual employed by the employer or agent of the employer who performs a preliminary screening procedure as defined in §B(19) of this regulation.</text> </paragraph> <paragraph num="(19)"> <text>“Preliminary screening procedure” means a controlled dangerous substance test:</text> <paragraph num="(a)"> <text>Using a single-use test device for forensic testing; and</text> </paragraph> <paragraph num="(b)"> <text>Performed by an employer or agent of the employer on a job applicant.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(21)"> <text>“Single-use test device for forensic testing” means the reagent-containing unit of a test system that:</text> <paragraph num="(a)"> <text>Is in the form of a sealed container or cartridge possessing a validity check;</text> </paragraph> <paragraph num="(b)"> <text>Possesses a nonresealable closure or an evidentiary tape to ensure detection of tampering;</text> </paragraph> <paragraph num="(c)"> <text>Is self-contained and individually packaged;</text> </paragraph> <paragraph num="(d)"> <text>Is discarded after each test; and</text> </paragraph> <paragraph num="(e)"> <text>Does not allow any test component or constituent of a test system to interact from test to test.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Specimen.</text> <paragraph num="(a)"> <text>“Specimen” means material derived from the human body and intended for laboratory testing.</text> </paragraph> <paragraph num="(b)"> <text>“Specimen” is limited to blood, urine, saliva, and hair.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibilities of the Secretary."> <paragraph num="A."> <text>Registration.</text> <paragraph num="(1)"> <text>Requirement. The OHCQ shall register on the Secretary's behalf an employer that conducts a preliminary screening procedure on a job applicant for a controlled dangerous substance.</text> </paragraph> <paragraph num="(2)"> <text>Forms. The OHCQ shall provide to each employer:</text> <paragraph num="(a)"> <text>A registration application form; and</text> </paragraph> <paragraph num="(b)"> <text>A registration renewal form every 2 years after the initial registration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Routine Surveys and Complaint Investigation.</text> <paragraph num="(1)"> <text>Requirement. The Secretary or the OHCQ as the Secretary's designee shall:</text> <paragraph num="(a)"> <text>Conduct routine surveys of preliminary screening sites;</text> </paragraph> <paragraph num="(b)"> <text>Conduct surveys of preliminary screening sites as part of a complaint investigation; and</text> </paragraph> <paragraph num="(c)"> <text>Investigate written complaints related to compliance with the standards set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On-site Surveys. The OHCQ may:</text> <paragraph num="(a)"> <text>Annually conduct routine on-site surveys of preliminary screening sites;</text> </paragraph> <paragraph num="(b)"> <text>Conduct a routine survey any time during a preliminary screening site's normal work hours; and</text> </paragraph> <paragraph num="(c)"> <text>Include as part of a routine survey or complaint investigation:</text> <paragraph num="(i)"> <text>On-site observation and examination of preliminary screening facilities, equipment, screening devices, specimens, and screening procedures;</text> </paragraph> <paragraph num="(ii)"> <text>On-site examination of documents pertinent to employer registration, preliminary screening performed by the employer or agent of the employer, and operator training; and</text> </paragraph> <paragraph num="(iii)"> <text>On-site interviews of employers and employees involved in performing, supervising, or managing preliminary screening.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Sanctions.</text> <paragraph num="(a)"> <text>Imposition. If the Secretary finds that an employer or agent of an employer is not in compliance with a requirement or standard of this chapter, the Secretary may impose one or more of the following sanctions on the employer, agent of the employer, or both:</text> <paragraph num="(i)"> <text>Suspension of a letter or letters of registration;</text> </paragraph> <paragraph num="(ii)"> <text>Revocation of a letter or letters of registration;</text> </paragraph> <paragraph num="(iii)"> <text>A direct plan of correction;</text> </paragraph> <paragraph num="(iv)"> <text>A limitation on preliminary screening; and</text> </paragraph> <paragraph num="(v)"> <text>Required training and technical assistance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Departmental Actions. The Secretary shall carry out actions related to the imposition or lifting of sanctions involving preliminary screenings in the same manner as those involving a laboratory, as set forth in COMAR 10.10.08, including the providing of notice and hearings.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Employer Requirements."> <text>An employer who for job-related reasons requires an individual to be tested for alcohol or controlled dangerous substances shall:</text> <paragraph num="A."> <text>Have the specimen tested by a laboratory that holds a Maryland license in the discipline of job-related alcohol and controlled dangerous substances testing; and</text> </paragraph> <paragraph num="B."> <text>At the time of testing and at the individual's request, inform the person of the name and address of the laboratory that will test the specimen.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Permissible Specimens."> <paragraph num="A."> <text>General. An employer requiring job-related alcohol or controlled dangerous substances testing shall require that:</text> <paragraph num="(1)"> <text>A job applicant provide only one or more of the following types of specimen:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Urine;</text> </paragraph> <paragraph num="(c)"> <text>Saliva; and</text> </paragraph> <paragraph num="(d)"> <text>Hair; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An employee or contractor provide only one or more of the following types of specimen:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Saliva; and</text> </paragraph> <paragraph num="(c)"> <text>Urine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Specimen Types. An employer requiring job-related alcohol or controlled dangerous substances testing may not require the testing of any specimen other than:</text> <paragraph num="(1)"> <text>Blood, urine, saliva, or hair, for a job applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Blood, saliva, or urine, for an employee or contractor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Hair. An employer may require that a job applicant submit a hair specimen for controlled dangerous substances testing if the hair specimen is:</text> <paragraph num="(1)"> <text>Less than or equal to 1-1/2 inches in length measured from the human body;</text> </paragraph> <paragraph num="(2)"> <text>Tested only for preemployment purposes; and</text> </paragraph> <paragraph num="(3)"> <text>Not used for a purpose other than controlled dangerous substances testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specimen Collection and Handling Procedures."> <paragraph num="A."> <text>Chain of Custody. A person collecting a specimen shall employ quality assurance and chain-of-custody procedures that include:</text> <paragraph num="(1)"> <text>Collecting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering;</text> </paragraph> <paragraph num="(2)"> <text>Collecting, handling, storing, and shipping a specimen in a manner that:</text> <paragraph num="(a)"> <text>Maintains its identity, confidentiality, and physical integrity; and</text> </paragraph> <paragraph num="(b)"> <text>Precludes specimen contamination or adulteration; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documenting each time a person accesses or transfers the specimen.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specimen Quantity. A person collecting a specimen shall collect a quantity sufficient to perform an initial screening test, a confirmation test, and an independent test.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Protections for Job Applicants, Employees, and Contractors."> <paragraph num="A."> <text>Notice of Positive Test Results.</text> <paragraph num="(1)"> <text>An employer who requires a job applicant, employee, or contractor to be tested for job-related reasons for the use or abuse of a controlled dangerous substance or alcohol and who receives notice that a job applicant, employee, or contractor has tested positive for a controlled dangerous substance or alcohol shall provide to the job applicant, employee, or contractor with a confirmed positive test result:</text> <paragraph num="(a)"> <text>A copy of the laboratory test indicating the test results;</text> </paragraph> <paragraph num="(b)"> <text>A copy or written summary of the employer's policy covering an employee, contractor, or job applicant with a confirmed positive test result;</text> </paragraph> <paragraph num="(c)"> <text>If applicable, written notice of the employer's intent to take disciplinary action, terminate employment, or change the conditions of continued employment; and</text> </paragraph> <paragraph num="(d)"> <text>A statement or copy of the provisions set forth in §B of this regulation permitting a job applicant, employee, or contractor to request independent testing of the same sample for verification of the test result.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The employer shall deliver the information required to be provided under §A of this regulation to the job applicant, employee, or contractor:</text> <paragraph num="(a)"> <text>Either in person or by certified mail; and</text> </paragraph> <paragraph num="(b)"> <text>Within 7 days from the date confirmed positive test results are received by the employer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Right to an Independent Test.</text> <paragraph num="(1)"> <text>Challenge. A job applicant, employee, or contractor who is required to submit to job-related alcohol or controlled dangerous substances testing may request that an independent test be performed on the same specimen in a confirmation test by:</text> <paragraph num="(a)"> <text>Notifying the employer and the laboratory that performed the confirmation test of the challenge to that test result; and</text> </paragraph> <paragraph num="(b)"> <text>Requesting that laboratory to submit a sufficient portion of the original specimen to a different laboratory chosen by the job applicant, employee, or contractor and licensed by the Secretary to perform alcohol or controlled dangerous substances testing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Testing Sensitivity. The job applicant, employee, or contractor shall employ as an independent testing laboratory one that will perform the independent test using detection levels for alcohol or controlled dangerous substances equal to or lower than those provided by the laboratory that performed the initial confirmation test.</text> </paragraph> <paragraph num="(3)"> <text>Costs. The job applicant, employee, or contractor shall pay all costs of independent testing including any costs associated with specimen handling and transport.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Confidentiality."> <paragraph num="A."> <text>General. Except as otherwise provided in an employer's written drug testing policy, in this regulation, or in Health-General Article, §17-214, Annotated Code of Maryland, all information, interviews, reports, statements, memoranda, and test results received or produced as a result of job-related alcohol or controlled dangerous substances testing are confidential and may be released only under a lawful subpoena, court order, or a release signed by the individual tested, or, in the case of a minor, by the individual's parent or legal guardian.</text> </paragraph> <paragraph num="B."> <text>Nonprescription and Medically Prescribed Drugs. In the course of obtaining information for, or as a result of, conducting job-related alcohol or controlled dangerous substances testing for an employer, a laboratory, a physician, including a physician retained by the employer, or any other person, may not reveal to the employer information regarding the use of a:</text> <paragraph num="(1)"> <text>Nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or</text> </paragraph> <paragraph num="(2)"> <text>Medically prescribed drug, unless the individual being tested is unable to establish that the drug was medically prescribed under the laws of the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Preliminary Screening by an Employer or Agent of the Employer."> <paragraph num="A."> <text>In addition to any other applicable requirements in this chapter, an employer or agent of the employer that performs a preliminary preemployment screening procedure for a controlled dangerous substance on a job applicant shall meet the standards set forth in this regulation.</text> </paragraph> <paragraph num="B."> <text>Registration Requirement. An employer or agent of the employer shall register the employer initially and every 2 years thereafter with the OHCQ by:</text> <paragraph num="(1)"> <text>Submitting to the OHCQ a registration form that:</text> <paragraph num="(a)"> <text>Lists the permanent office location of the employer and any agent of the employer in the State;</text> </paragraph> <paragraph num="(b)"> <text>Lists the permanent locations where the employer or agent of the employer performs preliminary screenings; and</text> </paragraph> <paragraph num="(c)"> <text>States whether the employer or agent of the employer performs preliminary screenings at temporary sites, uses mobile screening vehicles, or both; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Submitting to the OHCQ a registration fee of $50.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Single-Use Test Device. An employer or agent of the employer shall limit screening procedures to those that employ an FDA-cleared or approved single-use test device as defined in Regulation .03B(21) of this chapter.</text> </paragraph> <paragraph num="D."> <text>Trained Operator. To perform a preliminary screening procedure, an employer or agent of the employer shall employ an operator who has been trained for each type of device to be used, including instruction that includes the operator's:</text> <paragraph num="(1)"> <text>Reading the test manufacturer's package insert sheet;</text> </paragraph> <paragraph num="(2)"> <text>Observing the test manufacturer's training video or receiving training:</text> <paragraph num="(a)"> <text>From the test manufacturer;</text> </paragraph> <paragraph num="(b)"> <text>From an individual trained by the manufacturer; or</text> </paragraph> <paragraph num="(c)"> <text>Endorsed by the manufacturer;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completing the test manufacturer's self-administered test; and</text> </paragraph> <paragraph num="(4)"> <text>Performing tests, interpreting test results, and reporting results to job applicants under the supervision of a trained operator.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Training Records.</text> <paragraph num="(1)"> <text>Requirement. An employer or agent of the employer shall establish and maintain training records that document the training required to properly perform a screening procedure.</text> </paragraph> <paragraph num="(2)"> <text>Documentation. An employer or agent of the employer shall:</text> <paragraph num="(a)"> <text>Keep a record of the training received by a trainee;</text> </paragraph> <paragraph num="(b)"> <text>Document that a trainee has demonstrated competency in performing the screening procedure; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain for at least 2 years documentation that the trainee has been trained as set forth in this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Quality Assurance. An employer or agent of the employer shall:</text> <paragraph num="(1)"> <text>Limit screening procedures to those that employ an FDA-cleared or FDA-approved single-use test device for forensic testing, as defined in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Perform preliminary screening tests in accordance with the quality standards set forth in COMAR 10.10.03.02C(2) and (3);</text> </paragraph> <paragraph num="(3)"> <text>Collect and handle all specimens and ship non-negative specimens for testing, in a manner that:</text> <paragraph num="(a)"> <text>Maintains the specimen donor's identity and confidentiality; and</text> </paragraph> <paragraph num="(b)"> <text>Precludes contamination of and tampering with the specimen;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide a secure area with limited access to store a non-negative specimen before it is shipped to a laboratory and while it is retained pending:</text> <paragraph num="(a)"> <text>Confirmatory testing;</text> </paragraph> <paragraph num="(b)"> <text>Notice;</text> </paragraph> <paragraph num="(c)"> <text>Any independent testing; and</text> </paragraph> <paragraph num="(d)"> <text>Final disposal;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Submit a non-negative specimen subjected to a preliminary screening procedure to a licensed medical laboratory for confirmatory testing within 24 hours of screening;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a written record of the chain-of-custody for a specimen from the time it is collected until it is no longer needed for retesting or confirmatory testing;</text> </paragraph> <paragraph num="(7)"> <text>Have a medical review officer, as defined in Regulation .03B(15) of this chapter, review positive test results resulting from a confirmatory test; and</text> </paragraph> <paragraph num="(8)"> <text>Retain for at least 1 year all records pertaining to preliminary screening.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Notice and Independent Testing. An employer or agent of the employer who receives notice that a job applicant has tested positive for a controlled dangerous substance shall:</text> <paragraph num="(1)"> <text>Provide to the job applicant the items specified in Regulation .08A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the job applicant of the right to request that an independent test be performed on the same specimen, as set forth in Regulation .08B of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Voluntary Disclosure.</text> <paragraph num="(1)"> <text>For the purposes of facilitating hiring, a job applicant may voluntarily disclose and provide documentation to an operator that the job applicant is using:</text> <paragraph num="(a)"> <text>A nonprescription drug that is not prohibited under the laws of the State;</text> </paragraph> <paragraph num="(b)"> <text>A medically prescribed drug; or</text> </paragraph> <paragraph num="(c)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An operator may disclose to the employer information involving the use of medically prescribed and nonprohibited nonprescription drugs voluntarily disclosed and documented to the operator by the job applicant.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Surveys and Complaint Investigations. An employer or agent of an employer shall permit the OHCQ to conduct an on-site survey of a preliminary screening site at any time during the screening site's normal hours of operation as part of a complaint investigation or routine inspection to determine compliance with the applicable requirements and standards set forth in this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-202 and 17-214, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 5, 1998 (25:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Chapter, COMAR 10.10.05, recodified to COMAR 10.10.10 effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended effective July 22, 2002 (29:14 Md. R. 1074)</annotation> </annotations> </chapter> <chapter num="11" heading="Biological Agents Registry Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to help protect the people of Maryland against the potential threat of biological terrorism by establishing a program to register persons that possess, maintain, transfer, or receive biological agents in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter contains the standards and requirements a person that possesses, maintains, transfers, or receives a biological agent in this State shall meet to comply with the registration of biological agents.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to a biological agent or a certified laboratory or facility that is exempt from the requirements for the interstate shipment of etiologic agents under 42 CFR §§73.5 and 73.6, 9 CFR §§121.5 and 121.6, and 7 CFR §331.5.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Access” means the ability or the means necessary to:</text> <paragraph num="(a)"> <text>Read, write, modify, or communicate BAR information; or</text> </paragraph> <paragraph num="(b)"> <text>Otherwise make use of any system resource related to BAR information.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Access control” means a method of restricting access to a BAR information resource, allowing only an authorized individual access to the resource.</text> </paragraph> <paragraph num="(3)"> <text>“Authentication” means the corroboration that a person is the one claimed.</text> </paragraph> <paragraph num="(4)"> <text>“BAR” means the Department’s Biological Agents Registry.</text> </paragraph> <paragraph num="(5)"> <text>BAR Information.</text> <paragraph num="(a)"> <text>“BAR information” means information submitted to the BAR Program by a person required to report a biological agent under this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“BAR information” identifies:</text> <paragraph num="(i)"> <text>A person in this State who possesses, maintains, transfers, or receives a biological agent; and</text> </paragraph> <paragraph num="(ii)"> <text>The biological agents possessed, maintained, transferred, and received by a person in this State.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“BAR information” includes:</text> <paragraph num="(i)"> <text>Information contained in any of the documents and records that the BAR Program collects, requests, maintains, processes, or stores;</text> </paragraph> <paragraph num="(ii)"> <text>Information released by the BAR Program, a trusted partner, or a BAR information custodian; and</text> </paragraph> <paragraph num="(iii)"> <text>Biological agent incident response plans submitted to a local jurisdiction as required by this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>BAR Information Custodian.</text> <paragraph num="(a)"> <text>“BAR information custodian” means an individual designated by a trusted partner and authorized by the Department in a trusted partner agreement to receive and maintain BAR information.</text> </paragraph> <paragraph num="(b)"> <text>“BAR information custodian” may include:</text> <paragraph num="(i)"> <text>A health officer or designee;</text> </paragraph> <paragraph num="(ii)"> <text>An Emergency Management Director or designee; and</text> </paragraph> <paragraph num="(iii)"> <text>Other alternately designated and authorized individuals with a legitimate need to know the BAR information as it relates to the performance of the person's duties.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“BAR Program” means the Department’s BAR Program within the Laboratories Administration’s Office of Laboratory Emergency Preparedness and Response.</text> </paragraph> <paragraph num="(8)"> <text>“Biological agent” means:</text> <paragraph num="(a)"> <text>A select agent or toxin listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4;</text> </paragraph> <paragraph num="(b)"> <text>A genetically modified microorganism or genetic element from an organism listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4, shown to produce or encode for a factor associated with disease; or</text> </paragraph> <paragraph num="(c)"> <text>A genetically modified microorganism or genetic element that contains nucleic acid sequences coding for a toxin listed in 42 CFR §§73.3 and 73.4, and 9 CFR §§121.3 and 121.4, or the toxin's subunits.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Biological Agent Incident.</text> <paragraph num="(a)"> <text>“Biological agent incident” means a breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to an individual's health and safety.</text> </paragraph> <paragraph num="(b)"> <text>“Biological agent incident” includes any situation that may cause or potentially cause an exposure to or release of a biological agent, as set forth in Regulation .12B of this chapter.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Biosafety Level (BSL)” means the level of work practices, facility design, and safety equipment to prevent transmission of biologic agents to workers, other individuals, and the environment, as defined in the BMBL.</text> </paragraph> <paragraph num="(11)"> <text>“Biosafety Level-2 (BSL-2)” means the BSL used when:</text> <paragraph num="(a)"> <text>Work is done with biological agents associated with human disease; and</text> </paragraph> <paragraph num="(b)"> <text>The route of transmission is by:</text> <paragraph num="(i)"> <text>Percutaneous injury;</text> </paragraph> <paragraph num="(ii)"> <text>Ingestion; or</text> </paragraph> <paragraph num="(iii)"> <text>Mucous membrane exposure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Biosafety Level-3 (BSL-3)” means the BSL used when:</text> <paragraph num="(a)"> <text>Work is done with indigenous or exotic agents associated with a potentially serious or lethal human disease; and</text> </paragraph> <paragraph num="(b)"> <text>The route of transmission is aerosol inhalation.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Biosafety Level-4 (BSL-4).</text> <paragraph num="(a)"> <text>“BSL-4” means the BSL used when work is done with a dangerous and exotic biological agent that poses a high risk of life-threatening or lethal human disease that:</text> <paragraph num="(i)"> <text>May be transmitted via the aerosol route;</text> </paragraph> <paragraph num="(ii)"> <text>Has an unknown mode of transmission; or</text> </paragraph> <paragraph num="(iii)"> <text>Has no available vaccine or therapy.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“BSL-4” includes the BSL used when the agent has a close or identical antigenic relationship to BSL-4 agents.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“BMBL” means the “Biosafety in Microbiological and Biomedical Laboratories”, which is incorporated by reference in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(15)"> <text>“Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services.</text> </paragraph> <paragraph num="(16)"> <text>“Compact Disc-Recordable (CD-R)” means a type of write once, read many compact disc format that allows one-time recording of digital information on the disc.</text> </paragraph> <paragraph num="(17)"> <text>Contingency Plan.</text> <paragraph num="(a)"> <text>“Contingency plan” means a plan for responding to an information system emergency.</text> </paragraph> <paragraph num="(b)"> <text>“Contingency plan” includes:</text> <paragraph num="(i)"> <text>Installing system information from backups;</text> </paragraph> <paragraph num="(ii)"> <text>Preparing critical facilities that can be used to facilitate continuity of operations in the event of an emergency; and</text> </paragraph> <paragraph num="(iii)"> <text>Recovering from a disaster.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Decryption” means reversing the protective encryption algorithm process to make the previously unintelligible plaintext available for further processing as intelligible plaintext.</text> </paragraph> <paragraph num="(19)"> <text>“Deficiency” means a documented lack of compliance with a standard or requirement of the BAR Program set forth in this chapter.</text> </paragraph> <paragraph num="(20)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(21)"> <text>“Emergency management director” means an individual appointed by the Governor of Maryland, who is directly responsible for the organization, administration, and operation of the local organization for emergency management in the local jurisdiction as set forth in Public Safety Article, §14-109, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>Encryption.</text> <paragraph num="(a)"> <text>“Encryption” means transforming confidential plaintext into ciphertext to protect it so that the data can be securely stored.</text> </paragraph> <paragraph num="(b)"> <text>“Encryption” includes encrypting with an algorithm that combines plaintext with other values called keys, or ciphers, so the data becomes unintelligible.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Etiologic” means disease causing.</text> </paragraph> <paragraph num="(24)"> <text>“Exposure” means the condition of being subjected to a biological agent which may have a harmful effect.</text> </paragraph> <paragraph num="(25)"> <text>“Facility” means a building or complex of buildings owned by the same person and located at a single mailing address.</text> </paragraph> <paragraph num="(26)"> <text>“Genetic element” means a nucleic acid sequence shown to produce or encode for a factor associated with a disease, a toxin, or a toxin's subunits.</text> </paragraph> <paragraph num="(27)"> <text>“Local jurisdiction” means a county of the State or Baltimore City.</text> </paragraph> <paragraph num="(28)"> <text>“Maintaining a biological agent” means manipulating or holding a biological agent to sustain or enhance viability, infectivity, or toxicity.</text> </paragraph> <paragraph num="(29)"> <text>“Maryland Institute for Emergency Medical Services Systems (MIEMSS)” means the unit established by Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(30)"> <text>“MDE” means the Maryland Department of the Environment.</text> </paragraph> <paragraph num="(31)"> <text>“MEMA” means the Maryland Emergency Management Agency.</text> </paragraph> <paragraph num="(32)"> <text>Nature of a Biological Agent.</text> <paragraph num="(a)"> <text>“Nature of a biological agent” means the term that describes the kind or type of material or organism the agent is.</text> </paragraph> <paragraph num="(b)"> <text>“Nature of a biological agent” includes:</text> <paragraph num="(i)"> <text>Toxin;</text> </paragraph> <paragraph num="(ii)"> <text>Bacterium;</text> </paragraph> <paragraph num="(iii)"> <text>Virus;</text> </paragraph> <paragraph num="(iv)"> <text>Rickettsia;</text> </paragraph> <paragraph num="(v)"> <text>Fungus;</text> </paragraph> <paragraph num="(vi)"> <text>Allergen;</text> </paragraph> <paragraph num="(vii)"> <text>Genetic element; or</text> </paragraph> <paragraph num="(viii)"> <text>Any combination of §B(32)(b)(i)—(vii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Nature of a biological agent” does not include the name or identity of the biological agent.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>Person.</text> <paragraph num="(a)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(b)"> <text>“Person” includes State and federal units of government.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Personal identification number (PIN)” means a number or code assigned to an individual and used to provide verification of identity.</text> </paragraph> <paragraph num="(35)"> <text>“Personal protective equipment (PPE)” means the type of physical barrier equipment necessary to:</text> <paragraph num="(a)"> <text>Protect an individual from contact with a biological agent; or</text> </paragraph> <paragraph num="(b)"> <text>Prevent transmission of a biological agent.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Possessing a biological agent” means handling, holding, maintaining, owning, or storing a biological agent within the State.</text> </paragraph> <paragraph num="(37)"> <text>Responsible Official.</text> <paragraph num="(a)"> <text>“Responsible official” means an individual designated by a person required to report under this chapter to act on the person's behalf.</text> </paragraph> <paragraph num="(b)"> <text>“Responsible official” includes an individual designated as an alternate responsible official who acts in the responsible official's absence.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Role-based access” means a security mechanism for granting user access to a computer information system containing BAR information, based upon the user's job function.</text> </paragraph> <paragraph num="(39)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(40)"> <text>“Security incident” means a situation when BAR information is:</text> <paragraph num="(a)"> <text>Intentionally or unintentionally released to an unauthorized person; or</text> </paragraph> <paragraph num="(b)"> <text>Otherwise compromised in a way that allows unauthorized access.</text> </paragraph> </paragraph> <paragraph num="(41)"> <text>Security Self-Assessment.</text> <paragraph num="(a)"> <text>“Security self-assessment” means a person's formal assessment of the sensitivity, vulnerabilities, and security of the person's operations and programs related to the BAR information the person receives, manipulates, stores, or transmits.</text> </paragraph> <paragraph num="(b)"> <text>“Security self-assessment” includes the:</text> <paragraph num="(i)"> <text>Procedures and processes for determining a person's compliance with the BAR information security standards in this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Documentation certifying to the BAR Program that a person meets the BAR information security standards;</text> </paragraph> <paragraph num="(iii)"> <text>Identification and management of security risks; and</text> </paragraph> <paragraph num="(iv)"> <text>Security standards self-assessment check list provided by the BAR Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(42)"> <text>“Technical security measure” means a process that is put in place to protect information and control individual access to information in order to guard data integrity, confidentiality, and availability.</text> </paragraph> <paragraph num="(43)"> <text>“Token” means an electronic device for authenticating user identification and allowing access to a door or computer information system.</text> </paragraph> <paragraph num="(44)"> <text>Toxin.</text> <paragraph num="(a)"> <text>“Toxin” means a biologically active poisonous substance that is:</text> <paragraph num="(i)"> <text>Produced by a living cell or an organism; and</text> </paragraph> <paragraph num="(ii)"> <text>Harmful to another organism.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Toxin” does not include:</text> <paragraph num="(i)"> <text>A poisonous substance produced by a living organism for medical purposes, inactivated for use as a vaccine; or</text> </paragraph> <paragraph num="(ii)"> <text>A toxin preparation for biomedical research use at a lethal dose of 50 percent (LD50) for vertebrates of more than 100 nanograms per kilogram body weight.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Transfer” means the physical relocation of a biological agent from one facility or person to another.</text> </paragraph> <paragraph num="(46)"> <text>Trusted Partner.</text> <paragraph num="(a)"> <text>“Trusted partner” means a person with whom the Department has a valid trusted partner agreement to receive, possess, maintain, and transfer or share BAR information, as set forth in this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Trusted partner” includes only MDE, MEMA, MIEMSS, and a local jurisdiction where a biological agent is located.</text> </paragraph> </paragraph> <paragraph num="(47)"> <text>Trusted Partner Agreement.</text> <paragraph num="(a)"> <text>“Trusted partner agreement” means a document describing the arrangement between the Department and a trusted partner regarding how, when, and to whom information is released from the BAR.</text> </paragraph> <paragraph num="(b)"> <text>“Trusted partner agreement” includes the documentation that describes all the policies, procedures, and mechanisms agreed upon to protect the integrity, confidentiality, and availability of BAR information.</text> </paragraph> </paragraph> <paragraph num="(48)"> <text>“User-based access” means a security mechanism used to grant system access to users, based upon the identity of the user.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>29 CFR §1910.1450, as amended.</text> </paragraph> <paragraph num="(2)"> <text>42 CFR 73, as amended.</text> </paragraph> <paragraph num="(3)"> <text>9 CFR 121, as amended.</text> </paragraph> <paragraph num="(4)"> <text>7 CFR 331, as amended.</text> </paragraph> <paragraph num="(5)"> <text>CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories”, 5th Edition, December 2009, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registering Under the Biological Agents Registry Program."> <text>A person in the State shall participate in and comply with the State's BAR Program by registering with and reporting to the Department, in the manner set forth in this chapter, the information required by the Department.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Compliance with Federal Standards."> <text>A person that possesses, maintains, transfers, or receives a biological agent shall comply with all safeguards contained in 42 CFR 73, 9 CFR 121, and 7 CFR 331 that apply to a person registered to transfer the same agent under federal law and regulation.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Responsibilities of the Department."> <text>The Department shall:</text> <paragraph num="A."> <text>Establish and maintain a registry that identifies the biological agents possessed, maintained, transferred, and received by a person in this State;</text> </paragraph> <paragraph num="B."> <text>Conduct facility surveys by mail, by on-site visit, or both, initially and periodically after that, to:</text> <paragraph num="(1)"> <text>Ensure compliance with the standards and requirements of the BAR Program; and</text> </paragraph> <paragraph num="(2)"> <text>Address any deficiencies or complaints;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provide or approve the forms that a person shall complete and submit to the Department under the BAR Program;</text> </paragraph> <paragraph num="D."> <text>Issue notice when a survey of a facility yields findings of deficiencies related to the standards or requirements of the BAR Program;</text> </paragraph> <paragraph num="E."> <text>Investigate a complaint that a facility or an employee is not complying with the standards or requirements of the BAR Program; and</text> </paragraph> <paragraph num="F."> <text>Release BAR information, as provided in this chapter, to:</text> <paragraph num="(1)"> <text>State and federal law enforcement agencies;</text> </paragraph> <paragraph num="(2)"> <text>CDC;</text> </paragraph> <paragraph num="(3)"> <text>Trusted partners; and</text> </paragraph> <paragraph num="(4)"> <text>The Secretary or designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsible Official; Alternate Responsible Official."> <paragraph num="A."> <text>A person required to report to the BAR Program under this chapter shall designate an individual to be the responsible official who:</text> <paragraph num="(1)"> <text>Is familiar with the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Has the authority and responsibility to act on the person's behalf related to a biological agent; and</text> </paragraph> <paragraph num="(3)"> <text>Shall ensure compliance with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The responsible person shall ensure that the annual inspection and specific reporting requirements and mechanisms are carried out in accordance with 42 CFR §73.9.</text> </paragraph> <paragraph num="C."> <text>A person required to report to the BAR Program under this chapter shall:</text> <paragraph num="(1)"> <text>Designate one or more individuals to be an alternate responsible official to act in the responsible official's absence; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the individual designated as an alternate responsible official has the authority required in §A of this regulation to ensure compliance with this chapter when acting in the responsible official's absence.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reporting Requirements."> <paragraph num="A."> <text>What to Report. Using reporting forms provided or approved by the Department, a person shall:</text> <paragraph num="(1)"> <text>Identify all non-exempt biological agents that the person possesses, maintains, transfers, or receives listed under:</text> <paragraph num="(a)"> <text>Select agents and toxins in:</text> <paragraph num="(i)"> <text>42 CFR §73.3;</text> </paragraph> <paragraph num="(ii)"> <text>9 CFR §121.3; and</text> </paragraph> <paragraph num="(iii)"> <text>7 CFR §331.3; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Overlap select agents and toxins in:</text> <paragraph num="(i)"> <text>42 CFR §73.4; and</text> </paragraph> <paragraph num="(ii)"> <text>9 CFR §121.4;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Indicate as part of the identification if a biological agent is:</text> <paragraph num="(a)"> <text>Viable or nonviable;</text> </paragraph> <paragraph num="(b)"> <text>Purified genomic material;</text> </paragraph> <paragraph num="(c)"> <text>Recombinant DNA;</text> </paragraph> <paragraph num="(d)"> <text>Used in small or large animal work;</text> </paragraph> <paragraph num="(e)"> <text>Used in large-scale production; and</text> </paragraph> <paragraph num="(f)"> <text>A toxin;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Identify the physical location of a laboratory and storage area within a facility where a biological agent is contained;</text> </paragraph> <paragraph num="(4)"> <text>Identify the biosafety level required for the biological agent; and</text> </paragraph> <paragraph num="(5)"> <text>Identify the individual in charge of the biological agent and information needed to contact that individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When to Report. A person shall:</text> <paragraph num="(1)"> <text>Complete and submit a report within 30 days of receiving a request to report from the Department;</text> </paragraph> <paragraph num="(2)"> <text>Submit a report of each transfer and receipt of a biological agent within 24 hours of completing a transfer as set forth in Regulation .10D of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Respond in writing to a deficiency notice from the Department within 10 work days of receiving the notice; and</text> </paragraph> <paragraph num="(4)"> <text>Respond in writing to notice of a complaint within 10 work days of receiving notice from the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Who Submits Reports. A person shall submit a report dated and signed by the:</text> <paragraph num="(1)"> <text>Individual who actually possesses, maintains, transfers, or receives and has charge of a biological agent; and</text> </paragraph> <paragraph num="(2)"> <text>Responsible official of the facility where the biological agent is located.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Where to Report. A person shall return all completed reports and other correspondence to the BAR Program, c/o Laboratories Administration, Maryland Department of Health.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent."> <text>A person possessing, maintaining, transferring, or receiving a biological agent at a facility located in the State shall:</text> <paragraph num="A."> <text>Possess a laboratory and personnel equipped and capable of handling the biological agents at BSL 2, 3, or 4, depending on the agent and the type of work being performed with the agent, as contained in the BMBL;</text> </paragraph> <paragraph num="B."> <text>Meet specific requirements for handling a toxin subject to this chapter as set forth in 29 CFR §1910.1450;</text> </paragraph> <paragraph num="C."> <text>Allow an official representative of the Department to determine compliance with the standards and requirements of this chapter by:</text> <paragraph num="(1)"> <text>Conducting an on-site inspection of the person's facility, including all:</text> <paragraph num="(a)"> <text>Storage areas;</text> </paragraph> <paragraph num="(b)"> <text>Laboratories; and</text> </paragraph> <paragraph num="(c)"> <text>Operations; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Examining and reviewing procedures and documentation related to biological agents;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Submit a copy of each completed CDC form documenting transfer or receipt of a biological agent, within 24 hours of completing a transfer or receipt, to the BAR Program; and</text> </paragraph> <paragraph num="E."> <text>Inform the Emergency Management Director or designee and health officer or designee in the local jurisdiction where the biological agent is located of the nature and facility location of each reported biological agent that is located in that jurisdiction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Reporting of Unauthorized Activities."> <text>On learning that there is an unauthorized activity involving a biological agent, including the unauthorized possession, unauthorized attempted possession, unauthorized maintenance, unauthorized transfer, or unauthorized receipt of a biological agent, a person shall immediately alert the Department by:</text> <paragraph num="A."> <text>Telephoning the:</text> <paragraph num="(1)"> <text>Laboratories Administration at 443-681-3787 or 410-925-3121 between 8 a.m. and 4:30 p.m. weekdays; or</text> </paragraph> <paragraph num="(2)"> <text>Department's emergency after-hours and weekend telephone line at 410-795-7365 at other times;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Asking the individual taking the call to direct the information being reported to the BAR Program or the Director of the Laboratories Administration; and</text> </paragraph> <paragraph num="C."> <text>Reporting details about the unauthorized activity set forth in this regulation, such as:</text> <paragraph num="(1)"> <text>The location of a facility and laboratory involved;</text> </paragraph> <paragraph num="(2)"> <text>The identity of a person possessing or attempting to possess a biological agent; and</text> </paragraph> <paragraph num="(3)"> <text>Other details pertinent to the report.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Biological Agent Incident Response Plan."> <paragraph num="A."> <text>Requirement. A person required to report under this chapter shall:</text> <paragraph num="(1)"> <text>Develop, implement, and maintain a written biological agent incident response plan;</text> </paragraph> <paragraph num="(2)"> <text>Review the plan annually and revise the plan as necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a copy of the plan and any amendments to the plan to the:</text> <paragraph num="(a)"> <text>Emergency management director in the local jurisdiction where the biological agent is located; and</text> </paragraph> <paragraph num="(b)"> <text>BAR Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A person required to submit a biological agent incident response plan shall:</text> <paragraph num="(1)"> <text>Coordinate the biological agent incident response plan with any facility-wide plans;</text> </paragraph> <paragraph num="(2)"> <text>Keep the biological agent incident response plan current to reflect actual procedures and practices;</text> </paragraph> <paragraph num="(3)"> <text>Locate and maintain the biological agent incident response plan in the workplace;</text> </paragraph> <paragraph num="(4)"> <text>Make the biological agent incident response plan available to employees;</text> </paragraph> <paragraph num="(5)"> <text>Ensure that the biological agent incident response plan fully describes the response procedures for:</text> <paragraph num="(a)"> <text>The theft, loss, or release of a biological agent;</text> </paragraph> <paragraph num="(b)"> <text>Inventory discrepancies;</text> </paragraph> <paragraph num="(c)"> <text>Security breaches, including in computer information systems;</text> </paragraph> <paragraph num="(d)"> <text>Severe weather and other natural disasters;</text> </paragraph> <paragraph num="(e)"> <text>Workplace violence;</text> </paragraph> <paragraph num="(f)"> <text>Bomb threats;</text> </paragraph> <paragraph num="(g)"> <text>Suspicious packages;</text> </paragraph> <paragraph num="(h)"> <text>Emergencies such as:</text> <paragraph num="(i)"> <text>Fire;</text> </paragraph> <paragraph num="(ii)"> <text>Gas leaks;</text> </paragraph> <paragraph num="(iii)"> <text>Explosions; and</text> </paragraph> <paragraph num="(iv)"> <text>Power outages;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Use of PPE;</text> </paragraph> <paragraph num="(j)"> <text>Use of onsite emergency equipment to protect both the facility and personnel;</text> </paragraph> <paragraph num="(k)"> <text>Employees to follow when performing:</text> <paragraph num="(i)"> <text>Rescue or medical duties;</text> </paragraph> <paragraph num="(ii)"> <text>Emergency medical treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>First aid;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Emergency evacuation, including:</text> <paragraph num="(i)"> <text>Type of evacuation;</text> </paragraph> <paragraph num="(ii)"> <text>Exit route assignments;</text> </paragraph> <paragraph num="(iii)"> <text>Safe distances; and</text> </paragraph> <paragraph num="(iv)"> <text>Places of refuge;</text> </paragraph> </paragraph> <paragraph num="(m)"> <text>Decontamination; and</text> </paragraph> <paragraph num="(n)"> <text>Site security and control;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Ensure that the plan includes procedures that explain the:</text> <paragraph num="(a)"> <text>Risks and hazards associated with any biological agent on the premises; and</text> </paragraph> <paragraph num="(b)"> <text>Actions to contain the biological agent;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Ensure that the plan contains the following information:</text> <paragraph num="(a)"> <text>The name and contact information for home, work, and emergencies, for the:</text> <paragraph num="(i)"> <text>Responsible official; and</text> </paragraph> <paragraph num="(ii)"> <text>Alternate responsible official;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Where applicable, the name and contact information for:</text> <paragraph num="(i)"> <text>The building owner and manager;</text> </paragraph> <paragraph num="(ii)"> <text>Tenants; and</text> </paragraph> <paragraph num="(iii)"> <text>The official in charge of the building's physical security;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Personnel roles and lines of authority and communication;</text> </paragraph> <paragraph num="(d)"> <text>Planning and coordination with local emergency responders; and</text> </paragraph> <paragraph num="(e)"> <text>A list of the PPE available and where the PPE is located in the facility;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Conduct drills or exercises at least annually to test and evaluate the effectiveness of the plan;</text> </paragraph> <paragraph num="(9)"> <text>Notify the Emergency Management Director in the local jurisdiction where the biological agent is located and the BAR Program before a drill or exercise is conducted;</text> </paragraph> <paragraph num="(10)"> <text>Notify the Emergency Management Director and the health officer in the local jurisdiction where the biological agent is located and the BAR Program immediately following a biological agent incident involving exposure or potential exposure as set forth in COMAR 10.06.01.03A;</text> </paragraph> <paragraph num="(11)"> <text>Prepare a report of the results of a drill, exercise, or biological agent incident;</text> </paragraph> <paragraph num="(12)"> <text>Review a report of the results of a drill, exercise, or biological incident to determine if the plan requires revision; and</text> </paragraph> <paragraph num="(13)"> <text>Within 10 days after a drill, exercise, or biological agent incident, submit a copy of the report to the:</text> <paragraph num="(a)"> <text>Emergency management director in the local jurisdiction where the biological agent is located; and</text> </paragraph> <paragraph num="(b)"> <text>BAR Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Monitoring Compliance. When a person submits a biological agent incident response plan to the BAR Program, the BAR Program shall verify that the person submitting the plan has provided the information for planning and coordinating with local emergency responders to the Emergency Management Director in the local jurisdiction where the biological agent is located.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="BAR Information Confidentiality and Release of BAR Information."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, a person shall keep information prepared for or maintained in the BAR, including biological agent incident response plans required by Regulation .12 of this chapter:</text> <paragraph num="(1)"> <text>Confidential; and</text> </paragraph> <paragraph num="(2)"> <text>Protected from unauthorized access and use.</text> </paragraph> </paragraph> <paragraph num="B."> <text>BAR information is not subject to State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Release or sharing of BAR information as authorized in this chapter does not render the BAR information released or shared a public record.</text> </paragraph> <paragraph num="D."> <text>Except as provided in §§G—I of this regulation, a person to whom BAR information has been released may not release the information to another person unless the release is approved by the BAR Program.</text> </paragraph> <paragraph num="E."> <text>The BAR Program may release BAR information only to:</text> <paragraph num="(1)"> <text>State and federal law enforcement agencies;</text> </paragraph> <paragraph num="(2)"> <text>CDC;</text> </paragraph> <paragraph num="(3)"> <text>BAR information custodians of trusted partners;</text> </paragraph> <paragraph num="(4)"> <text>The Secretary or designee; and</text> </paragraph> <paragraph num="(5)"> <text>The health officer of any affected jurisdiction.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Before the BAR Program releases BAR information to a person, except State and federal law enforcement agencies, the CDC, and the Department, the person shall:</text> <paragraph num="(1)"> <text>Enter into and maintain a trusted partner agreement;</text> </paragraph> <paragraph num="(2)"> <text>Conduct a BAR information security self-assessment; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the results of a BAR information security self-assessment to the BAR Program for approval.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Mutual Aid Response. When multiple local jurisdictions respond to an emergency or biological agent incident, the Emergency Management Director of one responding jurisdiction may share BAR information with an Emergency Management Director from another local jurisdiction, and the health officer of one jurisdiction may share BAR information with the health officer of another jurisdiction that is providing mutual aid by assisting with the emergency response.</text> </paragraph> <paragraph num="H."> <text>Emergency Release Activation Process.</text> <paragraph num="(1)"> <text>A trusted partner may release on an emergency basis BAR information about the nature and location of a biological agent to another trusted partner or emergency public safety personnel when:</text> <paragraph num="(a)"> <text>An on-site alarm goes off at a person's facility where a biological agent is located and an individual at the site is required to place a telephone call to a 9-1-1 center;</text> </paragraph> <paragraph num="(b)"> <text>A 9-1-1 center dispatches emergency public safety personnel to a site where a biological agent is known to be located; or</text> </paragraph> <paragraph num="(c)"> <text>There is a reported breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to the health and safety of the public or emergency public safety first responders.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>MIEMSS may release on an emergency basis the nature and location of a biological agent to a:</text> <paragraph num="(a)"> <text>Police officer, as defined in Public Safety Article, §3-201(e), Annotated Code of Maryland, who is responding to an emergency; and</text> </paragraph> <paragraph num="(b)"> <text>Fire, rescue, or emergency medical services entity, as defined in Public Safety Article, §7-101, Annotated Code of Maryland, when responding to an emergency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>24/7 Access to BAR Information.</text> <paragraph num="(1)"> <text>MDE, MEMA, and MIEMSS may act as a back-up to the BAR Program by maintaining:</text> <paragraph num="(a)"> <text>24/7 (24 hours a day, 7 days a week) access to BAR information; and</text> </paragraph> <paragraph num="(b)"> <text>Access to BAR information when a trusted partner does not have access to BAR information.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>MDE, MEMA, or MIEMSS may release BAR information regarding the nature and location of a biological agent to each other or another BAR Program trusted partner if the trusted partner is unable to obtain access to BAR information.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Emergency Release of Name or Identity of a Biological Agent. MDE, MEMA, or MIEMSS may release by any necessary means of communication the name or identity of the specific biological agent located at the site of an emergency response to protect the health and safety of the public and emergency response personnel if:</text> <paragraph num="(1)"> <text>There is:</text> <paragraph num="(a)"> <text>A breach in containment of a biological agent;</text> </paragraph> <paragraph num="(b)"> <text>An imminent threat of a breach of containment; or</text> </paragraph> <paragraph num="(c)"> <text>An exposure or potential exposure;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The breach or imminent threat of a breach, exposure, or potential exposure is confirmed by the:</text> <paragraph num="(a)"> <text>Responsible official; or</text> </paragraph> <paragraph num="(b)"> <text>Emergency public safety personnel at the scene of the emergency response;</text> </paragraph> <paragraph num="(c)"> <text>Occupational Health; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The release is approved by the Department's physician on-call.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Departmental Authorization to Release Name or Identity of Biological Agent.</text> <paragraph num="(1)"> <text>The Department's physician on-call may release the name or identity of a biological agent as required to mitigate the risk and treat those exposed based on the potential threat to the health and safety of the public.</text> </paragraph> <paragraph num="(2)"> <text>The Department's physician on-call shall decide when, how, and to whom to release the name or identity of the biological agent.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Notification Protocol.</text> <paragraph num="(1)"> <text>When there is a breach or imminent threat of a breach in containment of a biological agent, exposure, or potential exposure as described in §J of this regulation, the:</text> <paragraph num="(a)"> <text>Responsible official or other designated person shall immediately notify the Emergency Management Director and health officer of any affected jurisdiction;</text> </paragraph> <paragraph num="(b)"> <text>Public safety personnel responding to an emergency shall contact the public safety personnel's 9-1-1 center; and</text> </paragraph> <paragraph num="(c)"> <text>9-1-1 center personnel shall notify MIEMSS and each of the following individuals in the jurisdiction where the breach, exposure, or potential exposure occurred:</text> <paragraph num="(i)"> <text>The Emergency Management Director; and</text> </paragraph> <paragraph num="(ii)"> <text>The health officer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>When MIEMSS receives notice of a breach or an imminent threat of a breach of containment of a biological agent, exposure, or potential exposure, MIEMSS shall notify:</text> <paragraph num="(a)"> <text>The Department's:</text> <paragraph num="(i)"> <text>Physician on-call; and</text> </paragraph> <paragraph num="(ii)"> <text>BAR Program within the Office of Laboratory Emergency Preparedness and Response;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>MDE;</text> </paragraph> <paragraph num="(c)"> <text>MEMA;and</text> </paragraph> <paragraph num="(d)"> <text>The health officer of any affected jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Immediately after the health officer is notified by 9-1-1 center personnel, the health officer shall contact the Department’s physician on-call to:</text> <paragraph num="(a)"> <text>Verify the BAR information release; and</text> </paragraph> <paragraph num="(b)"> <text>Confirm a plan of action regarding:</text> <paragraph num="(i)"> <text>Release of BAR information; and</text> </paragraph> <paragraph num="(ii)"> <text>Measures to be taken to protect the health and safety of the public.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Using a form provided by the BAR Program, a trusted partner shall notify the BAR Program within 72 hours after the:</text> <paragraph num="(1)"> <text>Trusted partner's BAR information custodian releases or shares BAR information; or</text> </paragraph> <paragraph num="(2)"> <text>Trusted partner releases or shares BAR information with another trusted partner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Method of Non-Emergency Release of BAR Information."> <paragraph num="A."> <text>A person shall release and transfer BAR information to a trusted partner and a BAR information custodian in a secure manner, which includes the use of:</text> <paragraph num="(1)"> <text>Read-only optical or electronic media;</text> </paragraph> <paragraph num="(2)"> <text>Encryption, decryption, passwords, and firewalls;</text> </paragraph> <paragraph num="(3)"> <text>Copy protection to prevent unauthorized copying or duplication.</text> </paragraph> <paragraph num="(4)"> <text>A telephone;</text> </paragraph> <paragraph num="(5)"> <text>Voice mail;</text> </paragraph> <paragraph num="(6)"> <text>An electronic or mechanical recording device; and</text> </paragraph> <paragraph num="(7)"> <text>An internet communication system, such as voice-over-internet-protocol (VoIP).</text> </paragraph> </paragraph> <paragraph num="B."> <text>The BAR Program shall release BAR information to a BAR information custodian of a local jurisdiction, MDE, MEMA, and MIEMSS:</text> <paragraph num="(1)"> <text>When notified by the BAR Program that the BAR information is available for release; and</text> </paragraph> <paragraph num="(2)"> <text>On weekdays between the hours of 8:30 a.m. and 3:30 p.m.</text> </paragraph> </paragraph> <paragraph num="C."> <text>BAR Program staff shall document the release of all BAR information to trusted partners in a permanent record that contains the:</text> <paragraph num="(1)"> <text>Name of the BAR information custodian;</text> </paragraph> <paragraph num="(2)"> <text>Identity of the trusted partner;</text> </paragraph> <paragraph num="(3)"> <text>Means of release of BAR information, including but not limited to:</text> <paragraph num="(a)"> <text>Encrypted email; and</text> </paragraph> <paragraph num="(b)"> <text>CD-R; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Date and time of the release or delivery of the BAR information.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Release of BAR Information to Law Enforcement Agencies and CDC."> <text>The BAR Program may release BAR information to State and federal law enforcement agencies and the CDC without a trusted partner agreement if the release of BAR information is pursuant to:</text> <paragraph num="A."> <text>A communicable disease investigation commenced or conducted by:</text> <paragraph num="(1)"> <text>The Department; or</text> </paragraph> <paragraph num="(2)"> <text>A State or federal law enforcement agency having investigative authority; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>An investigation involving a release, theft, or loss of a biological agent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Release of BAR Information to Local Jurisdictions."> <paragraph num="A."> <text>The Department shall release to a local jurisdiction the BAR information listed in §C of this regulation for each biological agent located within the local jurisdiction, if the local jurisdiction:</text> <paragraph num="(1)"> <text>Enters into and maintains a trusted partner agreement with the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Limits the number of BAR information custodians in the local jurisdiction to the:</text> <paragraph num="(a)"> <text>Health officer or the health officer’s designee; and</text> </paragraph> <paragraph num="(b)"> <text>Emergency management director or the emergency management director’s designee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The local jurisdiction may use the BAR information for:</text> <paragraph num="(1)"> <text>Protecting emergency first-responders, including:</text> <paragraph num="(a)"> <text>Fire fighters;</text> </paragraph> <paragraph num="(b)"> <text>Police officers; and</text> </paragraph> <paragraph num="(c)"> <text>Emergency employees, including:</text> <paragraph num="(i)"> <text>Emergency medical personnel;</text> </paragraph> <paragraph num="(ii)"> <text>Rescue workers; and</text> </paragraph> <paragraph num="(iii)"> <text>Public health emergency responders;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Planning for emergency protection of the public related to the:</text> <paragraph num="(a)"> <text>Release of a biological agent; or</text> </paragraph> <paragraph num="(b)"> <text>Prevention of a release of a biological agent; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Conducting investigations related to biological agents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Information Released. The BAR Program shall inform the BAR information custodian in the local jurisdiction of the:</text> <paragraph num="(1)"> <text>Location in the local jurisdiction of the biological agent, including the:</text> <paragraph num="(a)"> <text>Facility or entity name; and</text> </paragraph> <paragraph num="(b)"> <text>Physical address of the facility;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nature of each biological agent; and</text> </paragraph> <paragraph num="(3)"> <text>The BSL or PPE necessary to protect emergency responders from contact with or transmission of the biological agent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Release of BAR Information to MDE, MEMA, and MIEMSS."> <text>The Department shall:</text> <paragraph num="A."> <text>Release separately to the BAR information custodians of MDE, MEMA, and MIEMSS the BAR information listed in §C of this regulation for each biological agent located within the State, if MDE, MEMA, and MIEMSS each separately becomes a trusted partner by:</text> <paragraph num="(1)"> <text>Entering and maintaining a trusted partner agreement with the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Authorizing and identifying the individual who is the designated BAR information custodian in the trusted partner agreement;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Make BAR information available to MDE, MEMA, and MIEMSS for the purpose of planning for the protection of the public related to the:</text> <paragraph num="(1)"> <text>Release of a biological agent, such as a breach in containment;</text> </paragraph> <paragraph num="(2)"> <text>Prevention of a release of a biological agent; and</text> </paragraph> <paragraph num="(3)"> <text>Mitigation and planning for the protection of:</text> <paragraph num="(a)"> <text>Critical infrastructure;</text> </paragraph> <paragraph num="(b)"> <text>Key assets; and</text> </paragraph> <paragraph num="(c)"> <text>Emergency public safety personnel; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Provide the following BAR information of each biological agent in the State that is registered under this chapter to the BAR information custodian of MDE, MEMA, and MIEMSS, including for the entity that possesses, maintains, transfers, or receives a biological agent:</text> <paragraph num="(1)"> <text>Name and contact information of:</text> <paragraph num="(a)"> <text>The responsible official;</text> </paragraph> <paragraph num="(b)"> <text>The alternate responsible official; and</text> </paragraph> <paragraph num="(c)"> <text>Other personnel or staff listed by the facility who are responsible for a biological agent;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Location of the biological agent, including the:</text> <paragraph num="(a)"> <text>Facility or entity name; and</text> </paragraph> <paragraph num="(b)"> <text>Physical address of the facility;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Name or identity of each biological agent;</text> </paragraph> <paragraph num="(4)"> <text>Nature of each biological agent;</text> </paragraph> <paragraph num="(5)"> <text>BSL necessary to handle safely and contain the biological agent; and</text> </paragraph> <paragraph num="(6)"> <text>PPE necessary to protect emergency responders from contact with or transmission of the biological agent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="BAR Information Updates."> <text>The Department shall provide updated BAR information to the BAR information custodians of all trusted partners authorized under this chapter:</text> <paragraph num="A."> <text>Within 30 days when there is an:</text> <paragraph num="(1)"> <text>Upward change in the BSL at a listed person's facility, for example from BSL-3 to BSL-4; or</text> </paragraph> <paragraph num="(2)"> <text>Addition to the BAR, including a new:</text> <paragraph num="(a)"> <text>Person possessing or maintaining a biological agent;</text> </paragraph> <paragraph num="(b)"> <text>Facility where a biological agent is located; or</text> </paragraph> <paragraph num="(c)"> <text>Biological agent; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>At least once each year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="BAR Information Security Standards — General."> <paragraph num="A."> <text>A trusted partner shall protect and maintain BAR information in a secure manner by limiting access only to a BAR information custodian who is:</text> <paragraph num="(1)"> <text>An individual designated by the trusted partner; and</text> </paragraph> <paragraph num="(2)"> <text>Authorized by the Department in a trusted partner agreement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before the Department shares BAR information with a trusted partner, the trusted partner shall:</text> <paragraph num="(1)"> <text>Develop, implement, and maintain administrative, physical, and technical security measures and practices to protect and safeguard the integrity, confidentiality, and availability of BAR information by managing and supervising the:</text> <paragraph num="(a)"> <text>Selection, execution, and use of security measures to protect BAR information; and</text> </paragraph> <paragraph num="(b)"> <text>Conduct of personnel in relation to the protection of BAR information;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assess potential risks and vulnerabilities to the BAR information in its possession using a BAR information security self-assessment checklist provided by the BAR Program; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a:</text> <paragraph num="(a)"> <text>Completed BAR information security self-assessment; and</text> </paragraph> <paragraph num="(b)"> <text>Document verifying that the trusted partner's BAR information custodian has successfully undergone a security risk assessment as described in 42 CFR §73.7.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a BAR information custodian believes that the security of BAR information has been or is suspected to have been misused, mishandled, lost, stolen, or otherwise compromised, the BAR information custodian shall immediately notify the:</text> <paragraph num="(1)"> <text>BAR Program; and</text> </paragraph> <paragraph num="(2)"> <text>Individuals who signed the BAR information custodian's trusted partner agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="BAR Information Security Standards — Administrative Procedures."> <text>A trusted partner shall establish and maintain administrative procedures to protect BAR information integrity, confidentiality, and availability, which include:</text> <paragraph num="A."> <text>Entering and maintaining with the Department a trusted partner agreement that certifies that the trusted partner shall:</text> <paragraph num="(1)"> <text>Establish and implement the policies and procedures to carry out the requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Designate a BAR information custodian;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Establishing and implementing a contingency plan for protecting confidentiality of and access to BAR information when responding to a disaster or computer information system emergency, which includes:</text> <paragraph num="(1)"> <text>Preparing critical facilities that can be used to facilitate continuing protection of BAR information in the event of an emergency;</text> </paragraph> <paragraph num="(2)"> <text>Disaster recovery procedures to follow in the event of:</text> <paragraph num="(a)"> <text>Fire;</text> </paragraph> <paragraph num="(b)"> <text>Vandalism;</text> </paragraph> <paragraph num="(c)"> <text>Natural disaster; or</text> </paragraph> <paragraph num="(d)"> <text>Computer information system failure;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An emergency mode operation plan that includes procedures for assuring continuing protection of BAR information when the trusted partner continues to operate in the event of:</text> <paragraph num="(a)"> <text>Fire;</text> </paragraph> <paragraph num="(b)"> <text>Vandalism;</text> </paragraph> <paragraph num="(c)"> <text>Natural disaster; or</text> </paragraph> <paragraph num="(d)"> <text>Computer information system failure; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Testing and revising procedures that document the process of periodically testing the written contingency plan procedures to determine:</text> <paragraph num="(a)"> <text>Weaknesses; and</text> </paragraph> <paragraph num="(b)"> <text>The subsequent process of revising the procedures, if necessary;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A mechanism for the receipt, viewing, manipulation, storage, release, dissemination, and disposal of BAR information;</text> </paragraph> <paragraph num="D."> <text>Information-use policies that ensure that BAR information is used only as specified in this chapter;</text> </paragraph> <paragraph num="E."> <text>Internal audit procedures for:</text> <paragraph num="(1)"> <text>Maintaining records of computer information system activity including:</text> <paragraph num="(a)"> <text>Logons;</text> </paragraph> <paragraph num="(b)"> <text>File accesses; and</text> </paragraph> <paragraph num="(c)"> <text>Security incidents; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Reviewing the records of computer information system activity for:</text> <paragraph num="(a)"> <text>Breaches in security; and</text> </paragraph> <paragraph num="(b)"> <text>Unauthorized access;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Personnel security procedures that ensure that only personnel who have the required authorizations and agency clearances have access to BAR information by:</text> <paragraph num="(1)"> <text>Providing oversight of unauthorized personnel when the personnel are performing their duties near BAR information, which includes:</text> <paragraph num="(a)"> <text>Supervision of maintenance personnel by an authorized and knowledgeable individual; and</text> </paragraph> <paragraph num="(b)"> <text>Assuring that unauthorized or unsupervised operating and maintenance personnel do not have and cannot acquire access to BAR information;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintaining and reviewing a record of access authorizations that documents the levels of access granted to an individual accessing BAR information;</text> </paragraph> <paragraph num="(3)"> <text>Establishing personnel clearance procedures as a protective measure applied to determine that an individual's access to BAR information is permissible; and</text> </paragraph> <paragraph num="(4)"> <text>Ensuring that BAR information computer information system users, including maintenance personnel, receive security awareness training;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Employee termination procedures for ending an employee's employment or a user's access to BAR information, which includes:</text> <paragraph num="(1)"> <text>Changing locks, lock combinations, or keypad codes when personnel knowledgeable of locks, lock combinations, or keypad codes no longer need to:</text> <paragraph num="(a)"> <text>Know the information; or</text> </paragraph> <paragraph num="(b)"> <text>Access BAR information;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Removal from access lists, including physical eradication of an individual's access privileges;</text> </paragraph> <paragraph num="(3)"> <text>Termination or deletion of an individual's access privileges to BAR information for which the individual currently has authorization and need-to-know access when the authorization and need-to-know access no longer exists; and</text> </paragraph> <paragraph num="(4)"> <text>Returning to the trusted partner any access devices, such as:</text> <paragraph num="(a)"> <text>Keys;</text> </paragraph> <paragraph num="(b)"> <text>Tokens;</text> </paragraph> <paragraph num="(c)"> <text>Badges; or</text> </paragraph> <paragraph num="(d)"> <text>Cards; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Training for all personnel concerning the vulnerabilities of the BAR information and ways to ensure the protection of BAR information, which include:</text> <paragraph num="(1)"> <text>Awareness training including:</text> <paragraph num="(a)"> <text>Password maintenance;</text> </paragraph> <paragraph num="(b)"> <text>Security incident reporting; and</text> </paragraph> <paragraph num="(c)"> <text>Viruses and other forms of malicious software;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Periodic security reminders of security concerns; and</text> </paragraph> <paragraph num="(3)"> <text>User education in:</text> <paragraph num="(a)"> <text>What to do if a virus is detected;</text> </paragraph> <paragraph num="(b)"> <text>Monitoring logon success or failure;</text> </paragraph> <paragraph num="(c)"> <text>How to report discrepancies; and</text> </paragraph> <paragraph num="(d)"> <text>Password management, including the:</text> <paragraph num="(i)"> <text>Rules to be followed in creating and changing passwords; and</text> </paragraph> <paragraph num="(ii)"> <text>Need to keep passwords confidential.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="BAR Information Security — Physical Safeguards."> <text>A trusted partner shall establish physical safeguards to guard BAR information integrity, confidentiality, and availability, which include:</text> <paragraph num="A."> <text>Physical protection of the personal computer system used for viewing BAR information and related buildings and equipment from:</text> <paragraph num="(1)"> <text>Fire;</text> </paragraph> <paragraph num="(2)"> <text>Natural and environmental hazards;</text> </paragraph> <paragraph num="(3)"> <text>Disasters; and</text> </paragraph> <paragraph num="(4)"> <text>Intrusion;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A secure work station location with physical safeguards to eliminate or minimize the possibility of unauthorized access to BAR information, including:</text> <paragraph num="(1)"> <text>Locating a personal computer used to access and view BAR information in a locked room;</text> </paragraph> <paragraph num="(2)"> <text>Restricting access to the locked room to authorized personnel by using:</text> <paragraph num="(a)"> <text>Electronic keypads;</text> </paragraph> <paragraph num="(b)"> <text>Electronic access badges; or</text> </paragraph> <paragraph num="(c)"> <text>Door locks;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Placing the computer monitor in a way that screen contents are not viewable by an unauthorized person;</text> </paragraph> <paragraph num="(4)"> <text>Locking file cabinets, desks, and desk drawers that contain BAR information:</text> <paragraph num="(a)"> <text>During nonworking hours; and</text> </paragraph> <paragraph num="(b)"> <text>When the BAR information custodian is not present in the immediate area; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Making BAR information nonviewable or unobtainable before admitting an unauthorized person into the workspace;</text> </paragraph> </paragraph> <paragraph num="C."> <text>BAR information media control procedures that govern the receipt, removal, and disposal of BAR information CD-R discs or thumb drives into or out of the facility, which include:</text> <paragraph num="(1)"> <text>Access control so that only the BAR information custodian can receive the BAR information media;</text> </paragraph> <paragraph num="(2)"> <text>Accountability procedures that trace the receipt, removal, and disposal of BAR information media;</text> </paragraph> <paragraph num="(3)"> <text>BAR information storage; and</text> </paragraph> <paragraph num="(4)"> <text>Tracking the disposal process and the final disposition of:</text> <paragraph num="(a)"> <text>Electronic BAR information; and</text> </paragraph> <paragraph num="(b)"> <text>BAR information hardware on which electronic BAR information is stored;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Emergency mode operation access controls that enable continuing protection to BAR information in the event of:</text> <paragraph num="(1)"> <text>Fire;</text> </paragraph> <paragraph num="(2)"> <text>Vandalism;</text> </paragraph> <paragraph num="(3)"> <text>Natural disaster; or</text> </paragraph> <paragraph num="(4)"> <text>BAR information computer information system failure;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A facility security plan to safeguard BAR information on the premises from unauthorized physical access, tampering, and theft;</text> </paragraph> <paragraph num="F."> <text>Verifying access authorizations before granting physical access;</text> </paragraph> <paragraph num="G."> <text>Maintaining documentation of repairs and modifications to the physical components of the facility including:</text> <paragraph num="(1)"> <text>Hardware;</text> </paragraph> <paragraph num="(2)"> <text>Walls;</text> </paragraph> <paragraph num="(3)"> <text>Doors; and</text> </paragraph> <paragraph num="(4)"> <text>Locks; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>Procedures governing the reception and hosting of visitors, including:</text> <paragraph num="(1)"> <text>Sign-in logs for visitors; and</text> </paragraph> <paragraph num="(2)"> <text>Providing escorts for visitors, if appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="BAR Information Security — Technical Security Measures."> <text>A trusted partner shall establish a system of technical security measures to protect BAR information integrity, confidentiality, and availability, which include:</text> <paragraph num="A."> <text>A BAR information security assessment to determine the sensitivity, vulnerabilities, and security of the trusted partner's programs and operations related to the BAR information the trusted partner:</text> <paragraph num="(1)"> <text>Receives;</text> </paragraph> <paragraph num="(2)"> <text>Views;</text> </paragraph> <paragraph num="(3)"> <text>Manipulates;</text> </paragraph> <paragraph num="(4)"> <text>Stores; or</text> </paragraph> <paragraph num="(5)"> <text>Transmits;</text> </paragraph> </paragraph> <paragraph num="B."> <text>An information system certification based on a technical evaluation as part of and in support of the security process, which establishes the extent to which the trusted partner's computer system used for BAR information meets the security requirements of this chapter;</text> </paragraph> <paragraph num="C."> <text>Establishing and utilizing procedures and processes to guard against unauthorized access to BAR information by using:</text> <paragraph num="(1)"> <text>Access controls that include:</text> <paragraph num="(a)"> <text>Emergency role-based access of BAR information that documents the instructions for obtaining BAR information during a crisis;</text> </paragraph> <paragraph num="(b)"> <text>User-based access; and</text> </paragraph> <paragraph num="(c)"> <text>The use of encryption and decryption;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An alarm that can sense an unauthorized access within the computer system and produce a signaled response such as a:</text> <paragraph num="(a)"> <text>System closure;</text> </paragraph> <paragraph num="(b)"> <text>Time-phased automatic shutdown and restart cycle; or</text> </paragraph> <paragraph num="(c)"> <text>Screen indicating a multiple password failure lockout;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Audit controls that record and examine system activity;</text> </paragraph> <paragraph num="(4)"> <text>Audit trails of the use of and access to BAR information collected and used to facilitate a security audit; and</text> </paragraph> <paragraph num="(5)"> <text>Event reporting that shows a screen message indicating an unauthorized request for BAR information access.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Establishing procedures and processes for computer system authorization control for an individual to obtain access for the use and disclosure of BAR information, which include:</text> <paragraph num="(1)"> <text>Role-based access;</text> </paragraph> <paragraph num="(2)"> <text>User-based access;</text> </paragraph> <paragraph num="(3)"> <text>BAR information authentication that corroborates that BAR information has not been altered or destroyed in an unauthorized manner by using a:</text> <paragraph num="(a)"> <text>Message authentication code; or</text> </paragraph> <paragraph num="(b)"> <text>Digital signature;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>BAR information custodian authentication that includes:</text> <paragraph num="(a)"> <text>Automatic logoff that causes an electronic session to terminate after a predetermined time of inactivity; and</text> </paragraph> <paragraph num="(b)"> <text>A unique user identifier:</text> <paragraph num="(i)"> <text>Made up of a combination alpha and numeric characters; and</text> </paragraph> <paragraph num="(ii)"> <text>Maintained in security procedures for identifying and tracking individual user identity; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A logon mechanism using a:</text> <paragraph num="(a)"> <text>Password;</text> </paragraph> <paragraph num="(b)"> <text>Personal identification number (PIN);</text> </paragraph> <paragraph num="(c)"> <text>Token; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §D(5)(a)—(c) of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A security configuration management plan that includes:</text> <paragraph num="(1)"> <text>A written security plan documenting the rules, procedures, and instructions concerning all components related to BAR information security;</text> </paragraph> <paragraph num="(2)"> <text>Hardware and software installation and maintenance reviews;</text> </paragraph> <paragraph num="(3)"> <text>Security testing to ensure that the selected security features are:</text> <paragraph num="(a)"> <text>Implemented as designed; and</text> </paragraph> <paragraph num="(b)"> <text>Adequate for the operational environment; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Virus checking on a routine and regular basis;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Security incident procedures that describe how to:</text> <paragraph num="(1)"> <text>Report security incidents and breaches; and</text> </paragraph> <paragraph num="(2)"> <text>Respond to and take action as a result of the receipt of a security incident report; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Sanction policies and procedures describing the disciplinary actions and notice of possible civil or criminal penalties an individual may be subject to for misuse or misappropriation of BAR information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Trusted Partner Agreement."> <paragraph num="A."> <text>Requirement. The Department may not share BAR information with a person until the person becomes a trusted partner by entering into a trusted partner agreement, using the form developed by the Department.</text> </paragraph> <paragraph num="B."> <text>The Department shall develop and use a trusted partner form that contains, as applicable, separate clauses that:</text> <paragraph num="(1)"> <text>Establish the length of time that the trusted partner agreement is in effect;</text> </paragraph> <paragraph num="(2)"> <text>Address that confidentiality will survive the termination, expiration, or cancellation of the trusted partner agreement and state that the trusted partner:</text> <paragraph num="(a)"> <text>May not use BAR information in a way that is detrimental to the Department;</text> </paragraph> <paragraph num="(b)"> <text>Shall keep BAR information confidential;</text> </paragraph> <paragraph num="(c)"> <text>Shall limit disclosure of BAR information only:</text> <paragraph num="(i)"> <text>To individuals with a legitimate need in performance of the individuals' duties; and</text> </paragraph> <paragraph num="(ii)"> <text>On a need-to-know basis as prescribed by this chapter; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Shall employ security policies that:</text> <paragraph num="(i)"> <text>Protect the confidentiality of BAR information; and</text> </paragraph> <paragraph num="(ii)"> <text>Prevent improper disclosures or access to BAR information;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Require the trusted partner to notify the Department whenever the trusted partner discloses BAR information as allowed by this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Warrant and represent that the trusted partner is in compliance with all applicable State and federal laws and regulations regarding BAR information;</text> </paragraph> <paragraph num="(5)"> <text>Require the trusted partner to execute a trusted partner agreement that upholds the standards and requirements in the trusted partner agreement that the trusted partner has with the Department;</text> </paragraph> <paragraph num="(6)"> <text>Require the trusted partner to notify the Department when there is:</text> <paragraph num="(a)"> <text>An improper or unauthorized:</text> <paragraph num="(i)"> <text>Disclosure of BAR information; or</text> </paragraph> <paragraph num="(ii)"> <text>Access to BAR information;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A misuse of BAR information;</text> </paragraph> <paragraph num="(c)"> <text>A computer information system compromise that affects BAR information; or</text> </paragraph> <paragraph num="(d)"> <text>An authorized release of BAR information as set forth in this chapter;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Address corrective action by stating:</text> <paragraph num="(a)"> <text>The steps necessary to prevent any further unauthorized disclosure and misuse of BAR information;</text> </paragraph> <paragraph num="(b)"> <text>That the trusted partner shall maintain an incident log of all unauthorized disclosures and misuse of BAR information; and</text> </paragraph> <paragraph num="(c)"> <text>That the trusted partner shall send a copy of incident log entries to the BAR Program;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Require the trusted partner to:</text> <paragraph num="(a)"> <text>Return the BAR information that was provided to the trusted partner; and</text> </paragraph> <paragraph num="(b)"> <text>Exercise due diligence to destroy all material based on BAR information in a manner that renders nonidentifiable all documents, memoranda, notes, or other writings created or prepared by or for the trusted partner or BAR information custodian;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Require the trusted partner to make available on demand to the Department all policies and procedures relevant to safeguarding BAR information;</text> </paragraph> <paragraph num="(10)"> <text>Address the authority of the individuals signing the trusted partner agreement that state that:</text> <paragraph num="(a)"> <text>The individuals signing the trusted partner agreement have the right and authority to execute the agreement on behalf of their respective entity; and</text> </paragraph> <paragraph num="(b)"> <text>No further approvals are necessary to make the trusted partner agreement binding;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>State that the trusted partner agreement is the entire agreement between the Department and the trusted partner;</text> </paragraph> <paragraph num="(12)"> <text>State that the trusted partner agreement may not be amended, except as agreed to by the Department in writing;</text> </paragraph> <paragraph num="(13)"> <text>State that no provision or clause in the trusted partner agreement may be waived unless approved in writing by the Department;</text> </paragraph> <paragraph num="(14)"> <text>Identify the individual designated by the trusted partner and authorized by the Department to receive, maintain, and if provided by this chapter, release BAR information;</text> </paragraph> <paragraph num="(15)"> <text>Attest that the BAR information custodian has the trusted partner's agency clearance to receive BAR information;</text> </paragraph> <paragraph num="(16)"> <text>Address a trusted partner's security policy that states the:</text> <paragraph num="(a)"> <text>Value of BAR information;</text> </paragraph> <paragraph num="(b)"> <text>Protection responsibilities; and</text> </paragraph> <paragraph num="(c)"> <text>Organizational commitment for a system to protect the integrity, confidentiality, and availability of BAR information; and</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>State that if a provision, section, subsection, sentence, clause, or phrase of the trusted partner agreement is held invalid, the remaining portions of the trusted partner agreement remain valid.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Penalties."> <paragraph num="A."> <text>Fine. A person who violates a provision of Health-General Article, Title 17, Subtitle 6, Annotated Code of Maryland, or this chapter is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision.</text> </paragraph> <paragraph num="B."> <text>Subsequent Offense. Each day a violation is continued after the first conviction is a subsequent offense.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§17-601—17-605, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 25, 2002 (29:23 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 31, 2006 (33:15 Md. R. 1280)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 23, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B, C amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> </annotations> </chapter> <chapter num="12" heading="Medical Laboratories — Public Health HIV Testing Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter sets the standards and requirements for a person to obtain and maintain a public health testing license to operate a public health testing program to perform rapid HIV antibody testing and rapid hepatitis C virus testing.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to public health testing programs approved by the Secretary to conduct rapid HIV antibody testing and rapid hepatitis C virus testing.</text> </paragraph> <paragraph num="C."> <text>This chapter does not apply to any other type of laboratory testing entity such as a:</text> <paragraph num="(1)"> <text>Point-of-care laboratory;</text> </paragraph> <paragraph num="(2)"> <text>Commercial reference laboratory;</text> </paragraph> <paragraph num="(3)"> <text>Hospital; or</text> </paragraph> <paragraph num="(4)"> <text>Physician office laboratory.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“CDC” means the federal Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="(2)"> <text>“CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Primary standard” means a general comprehensive standard or set of standards as defined in COMAR 10.10.01.03B.</text> </paragraph> <paragraph num="(5)"> <text>“Public health testing program” means a medical laboratory as defined in COMAR 10.10.01.03B that is affiliated or collaborating with the Department for the purpose of offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing approved by the Secretary.</text> </paragraph> <paragraph num="(6)"> <text>“Public health testing license” means a license as defined in COMAR 10.10.01.03B issued by the Secretary authorizing the director of a public health HIV or hepatitis C (HCV) testing program to offer or perform rapid HIV tests or rapid hepatitis C virus tests.</text> </paragraph> <paragraph num="(7)"> <text>Quality Assessment Plan.</text> <paragraph num="(a)"> <text>“Quality assessment plan” means a planned system of step-by-step activities to ensure that:</text> <paragraph num="(i)"> <text>Testing is being carried out according to the manufacturer's instructions;</text> </paragraph> <paragraph num="(ii)"> <text>Results are accurate and reliable; and</text> </paragraph> <paragraph num="(iii)"> <text>Problems and mistakes are found and corrected to avoid adverse outcomes.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Quality Control.</text> <paragraph num="(a)"> <text>“Quality control” means the policies and procedures defined in COMAR 10.10.01.03B that monitor and evaluate the analytical or test performance phase of the testing process.</text> </paragraph> <paragraph num="(b)"> <text>“Quality control” includes the operational techniques, tasks, or activities used to find and correct problems that might occur in the test system.</text> </paragraph> </paragraph> <paragraph num="(8-1)"> <text>“Rapid hepatitis C virus test” means a public health hepatitis test that:</text> <paragraph num="(a)"> <text>Uses whole blood as the specimen to detect hepatitis C antibodies;</text> </paragraph> <paragraph num="(b)"> <text>Is waived under the CLIA program; and</text> </paragraph> <paragraph num="(c)"> <text>Provides a test result while the individual being tested is waiting.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Rapid HIV antibody test” means a public health HIV test that:</text> <paragraph num="(a)"> <text>Uses whole blood or oral fluid as the specimen to detect HIV antibodies;</text> </paragraph> <paragraph num="(b)"> <text>Is waived under the CLIA program; and</text> </paragraph> <paragraph num="(c)"> <text>Provides a test result while the individual being tested is waiting.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter, the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 (2007)” is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing."> <paragraph num="A."> <text>A person shall obtain a public health testing license before offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing.</text> </paragraph> <paragraph num="B."> <text>A person may not:</text> <paragraph num="(1)"> <text>Offer or perform rapid HIV antibody testing or hepatitis C virus testing without obtaining a public health testing license issued under this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Transfer the public health testing license to another person.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may issue a public health testing license under this chapter if the Secretary determines that the public health testing program meets the requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Department shall issue a public health testing license that:</text> <paragraph num="(1)"> <text>States that the license is limited to the performance of rapid HIV antibody testing and rapid hepatitis C virus testing; and</text> </paragraph> <paragraph num="(2)"> <text>Lists the:</text> <paragraph num="(a)"> <text>Name of the director;</text> </paragraph> <paragraph num="(b)"> <text>Name of the public health testing program; and</text> </paragraph> <paragraph num="(c)"> <text>Address of the public health testing program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>To obtain, maintain, or renew a public health testing license, a person shall:</text> <paragraph num="(1)"> <text>Make records and reports available to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Possess a valid CLIA Certificate of Waiver from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(3)"> <text>Submit to the Department:</text> <paragraph num="(a)"> <text>When seeking an initial license or license renewal, a quality assessment plan that describes the testing activities;</text> </paragraph> <paragraph num="(b)"> <text>The location of all testing sites; and</text> </paragraph> <paragraph num="(c)"> <text>The name and address of the laboratory that will perform confirmatory tests for the person operating the public health testing program; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submit amendments or changes to the public health testing program's quality assessment plan to the Department and obtain the Department's approval prior to implementation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review each submitted quality assessment plan to determine compliance with the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Conduct on-site surveys of public health testing programs:</text> <paragraph num="(a)"> <text>To investigate a complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Periodically to determine compliance with this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Approve the plan for implementation by the public health testing program if the plan is in compliance with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Secretary may impose one or more sanctions as provided in COMAR 10.10.08.01—.03 if the Secretary determines that the public health testing program does not meet the standards of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Assessment Plan and Quality Control Requirements."> <paragraph num="A."> <text>Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program.</text> </paragraph> <paragraph num="B."> <text>Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and activities that occur before, during, and after testing and include the following components:</text> <paragraph num="(1)"> <text>Verifying, before performing a test; that:</text> <paragraph num="(a)"> <text>The testing process works as set forth in the manufacturer's test specifications and instructions;</text> </paragraph> <paragraph num="(b)"> <text>Personnel are trained and competent to perform assigned tasks;</text> </paragraph> <paragraph num="(c)"> <text>Procedures and logistics are in place for:</text> <paragraph num="(i)"> <text>Performing a confirmatory test;</text> </paragraph> <paragraph num="(ii)"> <text>Collecting a specimen for referral to a laboratory to perform a confirmatory test; or</text> </paragraph> <paragraph num="(iii)"> <text>Referring an individual to a health care provider to have a confirmatory test performed; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Biohazardous waste handling procedures are in place;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Troubleshooting procedures that:</text> <paragraph num="(a)"> <text>Detect and resolve a problem that occurs during the testing process;</text> </paragraph> <paragraph num="(b)"> <text>Require communication of a problem immediately to the director or appropriate supervisory personnel;</text> </paragraph> <paragraph num="(c)"> <text>State when to discontinue testing;</text> </paragraph> <paragraph num="(d)"> <text>Identify how to take corrective action in response to a problem; and</text> </paragraph> <paragraph num="(e)"> <text>State how to:</text> <paragraph num="(i)"> <text>Document a problem and the actions taken; and</text> </paragraph> <paragraph num="(ii)"> <text>Verify that a corrective action taken has addressed the problem;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Procedures and mechanisms to maintain records that document:</text> <paragraph num="(a)"> <text>Personnel training and competency;</text> </paragraph> <paragraph num="(b)"> <text>Specimen referral and transfer;</text> </paragraph> <paragraph num="(c)"> <text>Daily temperatures of the areas that will affect testing results;</text> </paragraph> <paragraph num="(d)"> <text>Quality control test results that include the:</text> <paragraph num="(i)"> <text>Results of the quality control test;</text> </paragraph> <paragraph num="(ii)"> <text>Date and time the control testing was performed;</text> </paragraph> <paragraph num="(iii)"> <text>Lot number and expiration of the test kit;</text> </paragraph> <paragraph num="(iv)"> <text>Lot number and expiration date of the quality controls; and</text> </paragraph> <paragraph num="(v)"> <text>Corrective actions taken if control results are invalid; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Test result records for the individuals who are tested that include the:</text> <paragraph num="(i)"> <text>Test result;</text> </paragraph> <paragraph num="(ii)"> <text>Date and time testing was performed;</text> </paragraph> <paragraph num="(iii)"> <text>Unique laboratory code for the individual being tested;</text> </paragraph> <paragraph num="(iv)"> <text>Test kit lot number and expiration date;</text> </paragraph> <paragraph num="(v)"> <text>Results of internal validity checks;</text> </paragraph> <paragraph num="(vi)"> <text>Action taken if a result is invalid;</text> </paragraph> <paragraph num="(vii)"> <text>Documentation of required confirmatory testing;</text> </paragraph> <paragraph num="(viii)"> <text>Documentation when a specimen is sent for confirmation or the individual is referred for a confirmatory test;</text> </paragraph> <paragraph num="(ix)"> <text>Confirmatory test results, when available; and</text> </paragraph> <paragraph num="(x)"> <text>Identity of the individual who performed the test.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Personnel Training and Competency."> <paragraph num="A."> <text>Primary Standard. A person seeking or holding a public health testing license shall ensure that the personnel of the public health testing program are trained in how to perform assigned tasks and responsibilities.</text> </paragraph> <paragraph num="B."> <text>Personnel Training Components. A person seeking or holding a public health testing license shall ensure that personnel training includes the following components:</text> <paragraph num="(1)"> <text>How to perform the test, including procedures performed before, during, and after testing;</text> </paragraph> <paragraph num="(2)"> <text>How the testing is integrated into the overall counseling and testing program;</text> </paragraph> <paragraph num="(3)"> <text>The components of the public health testing program's quality assessment plan; and</text> </paragraph> <paragraph num="(4)"> <text>The use of bloodborne pathogen precautions and biohazard safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Training Method. A person seeking or holding a public health testing license shall ensure that the public health testing program personnel training includes the following activities:</text> <paragraph num="(1)"> <text>Reading the manufacturer's instructions for performing the test;</text> </paragraph> <paragraph num="(2)"> <text>Observing a trained individual performing the test or viewing a video of a trained individual performing the test;</text> </paragraph> <paragraph num="(3)"> <text>Practicing the performance of the test with positive and negative controls;</text> </paragraph> <paragraph num="(4)"> <text>Practicing the specimen collection procedure; and</text> </paragraph> <paragraph num="(5)"> <text>Reviewing the procedures and forms on how to document the testing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Personnel Competency. A supervisor or qualified trainer shall assess and document the competency of the public health testing program personnel for each task for which the individual is responsible:</text> <paragraph num="(1)"> <text>Before the individual is permitted to perform testing without assistance for the first time;</text> </paragraph> <paragraph num="(2)"> <text>Annually; and</text> </paragraph> <paragraph num="(3)"> <text>When procedures or test systems are changed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person seeking or holding a public health testing license shall have available and ensure that personnel follow the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988” (2007).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standard Operating Procedures Manual."> <paragraph num="A."> <text>Primary Standard. A person seeking or holding a public health testing license shall develop and maintain a standard operating procedures manual (SOPM) that is available to and followed by the public health testing program personnel.</text> </paragraph> <paragraph num="B."> <text>A person seeking or holding a public health testing license shall ensure that the SOPM includes the step-by-step instructions for the operations, tasks, and techniques occurring before, during, and after testing, including:</text> <paragraph num="(1)"> <text>How to set up the testing site;</text> </paragraph> <paragraph num="(2)"> <text>Use of quality assessment plan components, policies, and procedures;</text> </paragraph> <paragraph num="(3)"> <text>The test manufacturer's product inserts and instructions;</text> </paragraph> <paragraph num="(4)"> <text>Standard precautions for bloodborne pathogens;</text> </paragraph> <paragraph num="(5)"> <text>Use of gloves and other personal protective equipment;</text> </paragraph> <paragraph num="(6)"> <text>Handling and disposal of biohazardous waste;</text> </paragraph> <paragraph num="(7)"> <text>How to provide testing information to an individual before the individual is tested;</text> </paragraph> <paragraph num="(8)"> <text>How to counsel an individual receiving screening test results; and</text> </paragraph> <paragraph num="(9)"> <text>How to refer an individual who has been tested for HIV antibodies or hepatitis C antibodies, or both, for services as prescribed in COMAR 10.18.08.10C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Public Health Testing Program Director."> <paragraph num="A."> <text>Primary Standard. A person seeking or holding a public health testing license shall employ or otherwise engage the services of a director to oversee and manage the public health testing program.</text> </paragraph> <paragraph num="B."> <text>The director of a public health testing program shall oversee the planning, organization, direction, operation, and review of the program's operations, including:</text> <paragraph num="(1)"> <text>Recruiting competent personnel;</text> </paragraph> <paragraph num="(2)"> <text>Providing and documenting initial training and continuing education of program personnel;</text> </paragraph> <paragraph num="(3)"> <text>Communicating and consulting with program personnel on a regular basis;</text> </paragraph> <paragraph num="(4)"> <text>Conducting and documenting periodic on-site visits at the testing sites;</text> </paragraph> <paragraph num="(5)"> <text>Maintaining the quality assessment plan; and</text> </paragraph> <paragraph num="(6)"> <text>Ensuring that the program, testing site, and personnel meet applicable federal requirements and all standards and requirements set forth in this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Manufacturer's Requirements."> <paragraph num="A."> <text>Primary Standard. In addition to meeting the quality assessment plan requirements set forth in Regulation .05 of this chapter, a person seeking or holding a public health testing license shall ensure that public health testing program personnel meet the requirements and follow the manufacturer's test specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used.</text> </paragraph> <paragraph num="B."> <text>A person seeking or holding a public health testing license shall ensure that public health testing program personnel pay attention to the precautions and warnings set forth in the manufacturer's testing specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used for:</text> <paragraph num="(1)"> <text>Product usage;</text> </paragraph> <paragraph num="(2)"> <text>Test system and kit controls; and</text> </paragraph> <paragraph num="(3)"> <text>The step-by-step instructions for performing the rapid HIV antibody test or rapid hepatitis C virus test.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Confirmatory Test."> <text>When an individual has a positive test result with the rapid HIV antibody test or rapid hepatitis C virus test, a person seeking or holding a public health testing license to offer or perform testing shall:</text> <paragraph num="A."> <text>Offer to perform a confirmatory test;</text> </paragraph> <paragraph num="B."> <text>Collect a specimen to refer to a laboratory to perform a confirmatory test; or</text> </paragraph> <paragraph num="C."> <text>Refer that individual to a health care provider to have a confirmatory test performed.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, B amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D, E amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 1, 2013 (40:6 Md. R. 473)</annotation> </annotations> </chapter> <chapter num="13" heading="Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>This chapter, together with COMAR 10.52.12, establishes a coordinated Statewide system for the screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development.</text> </paragraph> <paragraph num="B."> <text>This chapter also protects the public health by ensuring that accurate and reliable newborn screening and diagnostic test results are provided to a newborn infant's health care providers by requiring a medical laboratory performing screening tests, diagnostic tests, or both, on newborn infants for hereditary disorders, congenital disorders, or both, to:</text> <paragraph num="(1)"> <text>Operate under reliable procedures and test methods;</text> </paragraph> <paragraph num="(2)"> <text>Employ qualified personnel;</text> </paragraph> <paragraph num="(3)"> <text>Establish and maintain reliable quality control and quality assurance programs; and</text> </paragraph> <paragraph num="(4)"> <text>Interact effectively with components of the Department's coordinated Statewide Newborn Screening Program to identify newborn infants who may be at risk for a hereditary or congenital disorder.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Identifies standards and requirements for a medical laboratory performing screening tests, diagnostic tests, or both, for hereditary and congenital disorders on blood-spot specimens from newborn infants; and</text> </paragraph> <paragraph num="B."> <text>Addresses the following newborn screening and diagnostic tests:</text> <paragraph num="(1)"> <text>Screening tests, which are:</text> <paragraph num="(a)"> <text>First-tier tests; and</text> </paragraph> <paragraph num="(b)"> <text>Supplemental tests; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Diagnostic tests, which are:</text> <paragraph num="(a)"> <text>Second-tier tests; and</text> </paragraph> <paragraph num="(b)"> <text>Supplemental tests.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abnormal test result” means a first-tier, supplemental, or second-tier test result that:</text> <paragraph num="(a)"> <text>Falls outside the normal range for the analyte measured; and</text> </paragraph> <paragraph num="(b)"> <text>Triggers a request for additional testing or is diagnostic for a disorder.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Allele.</text> <paragraph num="(a)"> <text>“Allele” means any one of a series of two or more different forms of a gene or DNA sequence that can exist at a single locus on a chromosome.</text> </paragraph> <paragraph num="(b)"> <text>“Allele” includes the gene or DNA sequence for hemoglobin traits and disease states, such as hemoglobin S (HbS) for sickle cell disease.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Analyte” means the substance or chemical constituent in blood being measured in a screening test used to detect the disorders listed in Regulation .12C of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Birthing Facility.</text> <paragraph num="(a)"> <text>“Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants.</text> </paragraph> <paragraph num="(b)"> <text>“Birthing facility” includes a:</text> <paragraph num="(i)"> <text>Birthing service that is licensed or accredited as a unit of a hospital; and</text> </paragraph> <paragraph num="(ii)"> <text>Freestanding birthing center as defined in COMAR 10.05.02.01B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Blood-Spot Specimen.</text> <paragraph num="(a)"> <text>“Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests.</text> </paragraph> <paragraph num="(b)"> <text>“Blood-spot specimen” includes:</text> <paragraph num="(i)"> <text>The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth;</text> </paragraph> <paragraph num="(ii)"> <text>The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and</text> </paragraph> <paragraph num="(iii)"> <text>A blood-spot specimen collected subsequent to a blood-spot specimen specified in §B(5)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.52.12.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Borderline result” means a screening test result that is at or near the established cut-off level for a particular analyte.</text> </paragraph> <paragraph num="(7)"> <text>“CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988.</text> </paragraph> <paragraph num="(8)"> <text>Congenital Disorder.</text> <paragraph num="(a)"> <text>“Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth.</text> </paragraph> <paragraph num="(b)"> <text>“Congenital disorder” does not include a condition that results from:</text> <paragraph num="(i)"> <text>An intrauterine infection; or</text> </paragraph> <paragraph num="(ii)"> <text>A birth injury.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Council” means the State Advisory Council on Hereditary and Congenital Disorders.</text> </paragraph> <paragraph num="(10)"> <text>“Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested.</text> </paragraph> <paragraph num="(11)"> <text>“Cut-off level” means a pre-determined, measurable value established for an analyte detected by a screening test, where that value is used to determine when a newborn infant's test result is normal, borderline, or abnormal.</text> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(13)"> <text>“Diagnostic test” means a test that is used to establish or confirm the presence of a:</text> <paragraph num="(a)"> <text>Specific disease; or</text> </paragraph> <paragraph num="(b)"> <text>Hereditary or congenital disorder.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth.</text> </paragraph> <paragraph num="(15)"> <text>“First–tier test” means a blood test performed on a newborn infant’s blood-spot specimen that:</text> <paragraph num="(a)"> <text>Indicates the probable presence or absence of a hereditary or congenital disorder; or</text> </paragraph> <paragraph num="(b)"> <text>Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in COMAR 10.52.12.12.</text> </paragraph> <paragraph num="(17)"> <text>Hereditary Disorder.</text> <paragraph num="(a)"> <text>“Hereditary disorder” means a disorder that:</text> <paragraph num="(i)"> <text>Is transmissible through the genetic material deoxyribonucleic acid (DNA); or</text> </paragraph> <paragraph num="(ii)"> <text>Arises through the improper processing of information in the genetic material.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Hereditary disorder” includes:</text> <paragraph num="(i)"> <text>Hemoglobin disorders;</text> </paragraph> <paragraph num="(ii)"> <text>Metabolic disorders; and</text> </paragraph> <paragraph num="(iii)"> <text>Endocrine disorders.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility.</text> </paragraph> <paragraph num="(19)"> <text>“Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(18) of this regulation.</text> </paragraph> <paragraph num="(20)"> <text>“Metabolic Disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by:</text> <paragraph num="(a)"> <text>Direct analysis of the enzyme, hormone, or protein; or</text> </paragraph> <paragraph num="(b)"> <text>Testing for a substance whose metabolism is altered as a result of the defect.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Newborn” or “newborn infant” means an infant:</text> <paragraph num="(a)"> <text>Born in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Born on federal property within Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Born outside of Maryland to parents whose residence is in Maryland;</text> </paragraph> <paragraph num="(d)"> <text>From whom a blood-spot specimen was collected and submitted to the Department’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth;</text> </paragraph> <paragraph num="(e)"> <text>Who has a screening test requested by the Follow-Up Unit:</text> <paragraph num="(i)"> <text>For first-tier screening follow-up;</text> </paragraph> <paragraph num="(ii)"> <text>For confirmation of a previous screening test result; or</text> </paragraph> <paragraph num="(iii)"> <text>To assist with a newborn infant's diagnosis, therapy, or follow-up care; or</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Who is in Maryland.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Newborn Screening or Screening.</text> <paragraph num="(a)"> <text>“Newborn screening” or “screening” means one or more first-tier tests.</text> </paragraph> <paragraph num="(b)"> <text>“Newborn screening” or “screening” includes:</text> <paragraph num="(i)"> <text>First-tier testing on a first, second, or subsequent blood-spot specimen; and</text> </paragraph> <paragraph num="(ii)"> <text>Supplemental first-tier testing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>Newborn Screening Program.</text> <paragraph num="(a)"> <text>“Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that:</text> <paragraph num="(i)"> <text>Newborn infants are given the opportunity to be tested;</text> </paragraph> <paragraph num="(ii)"> <text>At risk newborn infants who are tested are identified and located;</text> </paragraph> <paragraph num="(iii)"> <text>Newborn infants are given access to necessary follow-up testing;</text> </paragraph> <paragraph num="(iv)"> <text>Diagnostic tests are available and the diagnosis is made or ruled out; and</text> </paragraph> <paragraph num="(v)"> <text>Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Newborn Screening Program” includes:</text> <paragraph num="(i)"> <text>The Department's public health laboratory as the sole screening laboratory;</text> </paragraph> <paragraph num="(ii)"> <text>Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a Departmental mutual aid agreement;</text> </paragraph> <paragraph num="(iii)"> <text>Supplemental and second-tier testing performed by a state public health laboratory or by a permitted commercial or research laboratory;</text> </paragraph> <paragraph num="(iv)"> <text>The Follow-Up Unit; and</text> </paragraph> <paragraph num="(v)"> <text>The State Advisory Council on Hereditary and Congenital Disorders.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Normal limit” means a measurable, numerical value or range that is considered not to indicate or establish the presence of a hereditary or congenital disorder.</text> </paragraph> <paragraph num="(25)"> <text>“Permittee” means a person issued a permit by the Secretary to operate a medical laboratory as defined in COMAR 10.10.01.03B.</text> </paragraph> <paragraph num="(26)"> <text>“Public health laboratory” means:</text> <paragraph num="(a)"> <text>The Department's public health laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Another state's public health laboratory or a commercial laboratory permitted in Maryland that is approved under a Departmental emergency mutual aid agreement to perform newborn screening tests on Maryland newborns.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>Quality Assessment Plan.</text> <paragraph num="(a)"> <text>“Quality assessment plan” means a planned system of step-by-step activities to ensure that:</text> <paragraph num="(i)"> <text>Testing is carried out according to the manufacturer's instructions;</text> </paragraph> <paragraph num="(ii)"> <text>Testing results are accurate and reliable;</text> </paragraph> <paragraph num="(iii)"> <text>Testing problems and errors are found and corrected to avoid adverse health outcomes for newborn infants; and</text> </paragraph> <paragraph num="(iv)"> <text>Testing results are reported and communicated in a timely manner as required by this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Quality control” has the meaning stated in COMAR 10.10.06.03B.</text> </paragraph> <paragraph num="(29)"> <text>Screening Test.</text> <paragraph num="(a)"> <text>“Screening test” means a first-tier test used to detect a hereditary or congenital disorder listed in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Screening test” includes a test performed on a:</text> <paragraph num="(i)"> <text>First screening blood-spot specimen;</text> </paragraph> <paragraph num="(ii)"> <text>Second screening blood-spot specimen; or</text> </paragraph> <paragraph num="(iii)"> <text>Subsequent screening blood-spot specimen.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Screening test” does not include a:</text> <paragraph num="(i)"> <text>Diagnostic test; or</text> </paragraph> <paragraph num="(ii)"> <text>Second-tier test.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal.</text> </paragraph> <paragraph num="(31)"> <text>Second-Tier Test.</text> <paragraph num="(a)"> <text>“Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result.</text> </paragraph> <paragraph num="(b)"> <text>“Second-tier test” includes a test that:</text> <paragraph num="(i)"> <text>Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or</text> </paragraph> <paragraph num="(iii)"> <text>Is diagnostic because it confirms the presence of a hereditary or congenital disorder.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(33)"> <text>“Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is:</text> <paragraph num="(a)"> <text>Used to detect a hereditary or congenital disorder not specified in Regulation .12C of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.52.12.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in Regulation .21B and C of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Permit."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>Except as set forth in a Departmental mutual aid agreement, the Department's public health laboratory is the sole laboratory that may hold a State permit to perform and that may perform a first-tier newborn screening test on a newborn infant.</text> </paragraph> <paragraph num="(2)"> <text>A medical laboratory other than the State's public health laboratory may obtain a permit to perform:</text> <paragraph num="(a)"> <text>A supplemental test;</text> </paragraph> <paragraph num="(b)"> <text>A second-tier test; or</text> </paragraph> <paragraph num="(c)"> <text>Supplemental and second-tier tests.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall:</text> <paragraph num="(1)"> <text>Obtain and maintain a valid:</text> <paragraph num="(a)"> <text>Permit issued by the Secretary to operate a medical laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>CLIA Certificate from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet applicable standards and requirements for:</text> <paragraph num="(a)"> <text>A medical laboratory, as set forth in COMAR 10.10.01—.08; and</text> </paragraph> <paragraph num="(b)"> <text>Testing for hereditary or congenital disorders in a newborn infant as set forth in this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspection Requirements."> <paragraph num="A."> <text>Inspection Authority. The Department may conduct on-site inspections of a permittee or applicant for a permit to perform supplemental or second-tier tests to screen for or diagnose congenital and hereditary disorders in newborn infants.</text> </paragraph> <paragraph num="B."> <text>Inspection Types. The Department may conduct the following types of inspections to assess compliance with the requirements of this subtitle and COMAR 10.52.12:</text> <paragraph num="(1)"> <text>An initial inspection before issuing a permit;</text> </paragraph> <paragraph num="(2)"> <text>A routine inspection during the permit period; and</text> </paragraph> <paragraph num="(3)"> <text>An inspection subsequent to a complaint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fees."> <paragraph num="A."> <text>Permit Fees. A permittee or applicant for a permit that is not exempt under COMAR 10.10.04.01C, or that is not another state's public health laboratory approved to provide newborn screening tests under a Departmental mutual aid agreement, shall pay to the Department the applicable fees as required by COMAR 10.10.04 and this regulation.</text> </paragraph> <paragraph num="B."> <text>Screening and Follow-up Fee Requirement. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay a fee of $163.74 per newborn infant to the Department.</text> </paragraph> <paragraph num="C."> <text>Screening and Follow-Up Fee Payment. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay to the Department the total fees owed:</text> <paragraph num="(1)"> <text>On a quarterly basis; and</text> </paragraph> <paragraph num="(2)"> <text>Within 30 days of receiving an invoice from the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Director Requirement, Qualifications, and Responsibilities."> <paragraph num="A."> <text>Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director.</text> </paragraph> <paragraph num="B."> <text>Director Qualifications. The director shall:</text> <paragraph num="(1)"> <text>Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04; and</text> </paragraph> <paragraph num="(2)"> <text>Possess a current license as a laboratory director issued by the state in which the laboratory is located if:</text> <paragraph num="(a)"> <text>The laboratory is not located in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Licensing is required by the state in which the laboratory is located.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Director Responsibilities. The director is responsible for:</text> <paragraph num="(1)"> <text>The overall operation and administration of the laboratory, including the employment of a sufficient number of competent personnel;</text> </paragraph> <paragraph num="(2)"> <text>Ensuring that each first-tier, supplemental, or second-tier test conducted is performed accurately and reliably in all aspects of the testing process, including the preanalytic, analytic, and post-analytic phases of the total testing process; and</text> </paragraph> <paragraph num="(3)"> <text>Ensuring compliance with:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>The applicable parts of COMAR 10.10.01— 10.10.08; and</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.52.12.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Technical Supervisor Requirement, Qualifications, and Responsibilities."> <paragraph num="A."> <text>Technical Supervisor Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a technical supervisor.</text> </paragraph> <paragraph num="B."> <text>Director as Technical Supervisor. The director may function as the technical supervisor if the director meets the technical supervisor qualifications specified in this regulation.</text> </paragraph> <paragraph num="C."> <text>Technical Supervisor Qualifications. The technical supervisor shall meet the qualifications for a technical supervisor set forth at COMAR 10.10.07.05A(1) and B(7).</text> </paragraph> <paragraph num="D."> <text>Technical Supervisor Responsibilities. A technical supervisor shall be:</text> <paragraph num="(1)"> <text>Responsible for the:</text> <paragraph num="(a)"> <text>Technical and scientific methods used in the laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Oversight of the laboratory;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Available to the laboratory personnel on an as-needed basis to provide supervision as specified in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Accessible to the laboratory to provide on-site, telephonic, or electronic consultation to laboratory personnel and clients.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Clinical Consultant Requirement, Qualifications, and Responsibilities."> <paragraph num="A."> <text>Clinical Consultant Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a clinical consultant.</text> </paragraph> <paragraph num="B."> <text>Director as Clinical Consultant. The director may function as the clinical consultant if the director meets the qualifications set forth under §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>Clinical Consultant Qualifications. The clinical consultant shall be:</text> <paragraph num="(1)"> <text>A doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy; and</text> </paragraph> <paragraph num="(2)"> <text>Board certified by the American Board of Medical Genetics as a:</text> <paragraph num="(a)"> <text>Clinical geneticist;</text> </paragraph> <paragraph num="(b)"> <text>Medical geneticist; or</text> </paragraph> <paragraph num="(c)"> <text>Biochemical geneticist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Consultant Responsibilities. A clinical consultant shall provide clinical consultation related to:</text> <paragraph num="(1)"> <text>Inquiries concerning specific newborn screening tests;</text> </paragraph> <paragraph num="(2)"> <text>Interpretation of specific test results;</text> </paragraph> <paragraph num="(3)"> <text>Possible diagnostic or supplemental testing; and</text> </paragraph> <paragraph num="(4)"> <text>Assistance in ensuring that appropriate tests are ordered to meet clinical expectations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="General Supervisor Requirement, Qualifications, and Responsibilities."> <paragraph num="A."> <text>General Supervisor Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a general supervisor.</text> </paragraph> <paragraph num="B."> <text>General Supervisor Qualifications. The general supervisor shall:</text> <paragraph num="(1)"> <text>Meet the qualifications for a general supervisor set forth at COMAR 10.10.07.06B(1); and</text> </paragraph> <paragraph num="(2)"> <text>Have at least 6 months experience supervising the operation of applicable test systems, including:</text> <paragraph num="(a)"> <text>Tandem mass spectrophotometry (MS/MS);</text> </paragraph> <paragraph num="(b)"> <text>Time-resolved immunofluorometry;</text> </paragraph> <paragraph num="(c)"> <text>Enzyme-linked immunosorbent assay (ELISA) systems; and</text> </paragraph> <paragraph num="(d)"> <text>Isoelectric focusing and high-performance liquid chromatography.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>General Supervisor Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463, including:</text> <paragraph num="(1)"> <text>Supervising the:</text> <paragraph num="(a)"> <text>Day-to-day operation of the laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Personnel performing tests and reporting test results; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Being accessible to testing personnel at all times testing is performed to provide on-site, telephonic, or electronic consultation and resolve technical problems in accordance with policies and procedures established and approved by the director and technical supervisor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Testing Personnel Requirement and Qualifications."> <paragraph num="A."> <text>Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ sufficient laboratory testing personnel to perform testing in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Qualifications. Testing personnel shall meet the qualifications set forth at COMAR 10.10.07.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="First-Tier, Supplemental, and Second-Tier Tests."> <paragraph num="A."> <text>First-Tier Tests; Requirement. The Department’s public health laboratory shall perform first-tier tests on all screening blood-spot specimens collected from a newborn infant.</text> </paragraph> <paragraph num="B."> <text>First-Tier Tests; Testing Limitations.</text> <paragraph num="(1)"> <text>Only the Department's public health laboratory may screen for the disorders listed in §C of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A permittee may perform a supplemental or a second-tier test only when the test is requested by an individual authorized to request a medical laboratory test as provided in COMAR 10.10.06.02.</text> </paragraph> </paragraph> <paragraph num="C."> <text>First-Tier Tests. The Department’s public health laboratory shall perform a first-tier test on a newborn infant to screen for the following hereditary and congenital disorders, which are approved for screening by the Council and the Secretary:</text> <paragraph num="(1)"> <text>Biotinidase deficiency;</text> </paragraph> <paragraph num="(2)"> <text>Congenital adrenal hyperplasia (CAH);</text> </paragraph> <paragraph num="(3)"> <text>Hypothyroidism;</text> </paragraph> <paragraph num="(4)"> <text>Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT);</text> </paragraph> <paragraph num="(5)"> <text>Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE);</text> </paragraph> <paragraph num="(6)"> <text>Galactokinase Galactosemia, galactokinase deficiency (GALK1);</text> </paragraph> <paragraph num="(7)"> <text>Sickle cell disease;</text> </paragraph> <paragraph num="(8)"> <text>Sickle cell disease: S beta-thalessemia;</text> </paragraph> <paragraph num="(9)"> <text>Sickle C disease: SC disease;</text> </paragraph> <paragraph num="(10)"> <text>Other hemoglobin variants;</text> </paragraph> <paragraph num="(11)"> <text>Phenylketonuria (PKU);</text> </paragraph> <paragraph num="(12)"> <text>Hyperphenylalaninemia (Hyper-PHE);</text> </paragraph> <paragraph num="(13)"> <text>Biopterin cofactor biosynthesis defects (BIOPT-BS);</text> </paragraph> <paragraph num="(14)"> <text>Biopterin cofactor regeneration defects (BIOPT-REG);</text> </paragraph> <paragraph num="(15)"> <text>Tyrosinemia, type I;</text> </paragraph> <paragraph num="(16)"> <text>Tyrosinemia, type II;</text> </paragraph> <paragraph num="(17)"> <text>Tyrosinemia, type III;</text> </paragraph> <paragraph num="(18)"> <text>Homocystinuria;</text> </paragraph> <paragraph num="(19)"> <text>Hypermethioninemia;</text> </paragraph> <paragraph num="(20)"> <text>Branched chain ketoaciduria (BCK), also called maple syrup urine disease (MSUD);</text> </paragraph> <paragraph num="(21)"> <text>Citrullinemia, type I;</text> </paragraph> <paragraph num="(22)"> <text>Citrullinemia, type II;</text> </paragraph> <paragraph num="(23)"> <text>Arginosuccinic aciduria;</text> </paragraph> <paragraph num="(24)"> <text>Argininemia;</text> </paragraph> <paragraph num="(25)"> <text>Methylmalonic acidemia, mutase deficiency (MMA);</text> </paragraph> <paragraph num="(26)"> <text>Methylmalonic acidemia, adenosylcobalamin synthesis defects A and B (Cbl A, B);</text> </paragraph> <paragraph num="(27)"> <text>Methylmalonic acidemia, adenosylcobalamin synthesis defects C and D (Cbl C, D);</text> </paragraph> <paragraph num="(28)"> <text>Propionic acidemia (PA);</text> </paragraph> <paragraph num="(29)"> <text>Isovaleric acidemia (IVA);</text> </paragraph> <paragraph num="(30)"> <text>Glutaric aciduria type I (GA I);</text> </paragraph> <paragraph num="(31)"> <text>3-Hydroxy-3-methylglutaryl-CoA (HMG) lysase deficiency;</text> </paragraph> <paragraph num="(32)"> <text>Isobutryl-CoA dehydrogenase (IBCD) deficiency;</text> </paragraph> <paragraph num="(33)"> <text>2-Methylbutyryl-CoA dehydrogenase deficiency (2MBG);</text> </paragraph> <paragraph num="(34)"> <text>3-Methlycrotonyl-CoA carboxylase deficiency (3MCC);</text> </paragraph> <paragraph num="(35)"> <text>3-Methlyglutaconyl-CoA hydratase deficiency (3MGA);</text> </paragraph> <paragraph num="(36)"> <text>2-Methyl-3-hydroxybutyrl-CoA dehydrogenase deficiency (2M3HBA);</text> </paragraph> <paragraph num="(37)"> <text>Mitochondrial acetoacetyl-CoA thiolase (3-ketothiolase) deficiency (BKT);</text> </paragraph> <paragraph num="(38)"> <text>Multiple carboxylase deficiency (MCD);</text> </paragraph> <paragraph num="(39)"> <text>Malonic acidemia (MAL);</text> </paragraph> <paragraph num="(40)"> <text>Medium chain acyl-CoA dehydrogenase deficiency (MCAD);</text> </paragraph> <paragraph num="(41)"> <text>Medium chain ketoacyl-CoA thiolase deficiency (MCKAT);</text> </paragraph> <paragraph num="(42)"> <text>Short chain acyl-CoA dehydrogenase deficiency (SCAD);</text> </paragraph> <paragraph num="(43)"> <text>Short chain 3-hydroxy acyl Co-A dehydrogenase deficiency (SCHAD);</text> </paragraph> <paragraph num="(44)"> <text>Very long chain acyl-CoA dehydrogenase deficiency (VLCAD);</text> </paragraph> <paragraph num="(45)"> <text>3-hydroxy long chain acyl-CoA dehydrogenase deficiency (LCHAD);</text> </paragraph> <paragraph num="(46)"> <text>Multiple acyl-CoA dehydrogenase (MAD) or glutaric acidemia type II deficiency (GA II);</text> </paragraph> <paragraph num="(47)"> <text>Carnitine/acylcarnitine translocase deficiency (translocase deficiency);</text> </paragraph> <paragraph num="(48)"> <text>Carnitine palmitoyl transferase type I deficiency (CPT I);</text> </paragraph> <paragraph num="(49)"> <text>Carnitine palmitoyl transferase type II deficiency (CPT II);</text> </paragraph> <paragraph num="(50)"> <text>Carnitine uptake disorder;</text> </paragraph> <paragraph num="(51)"> <text>Trifunctional protein deficiency (TFP);</text> </paragraph> <paragraph num="(52)"> <text>2,4-dienoyl-CoA reductase deficiency (DE RED);</text> </paragraph> <paragraph num="(53)"> <text>Cystic fibrosis;</text> </paragraph> <paragraph num="(54)"> <text>Severe combined immunodeficiency (SCID);</text> </paragraph> <paragraph num="(55)"> <text>Pompe disease;</text> </paragraph> <paragraph num="(56)"> <text>Fabry disease;</text> </paragraph> <paragraph num="(57)"> <text>Spinal muscular atrophy (SMA);</text> </paragraph> <paragraph num="(58)"> <text>Mucopolysaccharidosis type I (MPS I);</text> </paragraph> <paragraph num="(59)"> <text>Mucopolysaccharidosis type II (MPS II);</text> </paragraph> <paragraph num="(60)"> <text>X-linked Adrenoleukodystrophy (X-ALD);</text> </paragraph> <paragraph num="(61)"> <text>Guanidinoacetate Methyltransferase Deficiency (GAMT); and</text> </paragraph> <paragraph num="(62)"> <text>Infantile Krabbe Disease.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Approved Methods:</text> <paragraph num="(1)"> <text>A permittee shall use:</text> <paragraph num="(a)"> <text>A colorimetric method for testing for a biotinidase deficiency, which is the disorder listed at §C(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>A fluorometric method when testing for galactosemia, which is the disorder listed at §C(4)—(6) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>A fluorescent-linked immunoassay method when testing for the hereditary or congenital disorders listed in §C(2) and (3) of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Isoelectric focusing followed by high-performance liquid chromatography when testing for sickle cell disease, which is the disorder listed at §C(7)—(10) of this regulation;</text> </paragraph> <paragraph num="(e)"> <text>Tandem mass-spectrometry when testing for the metabolic disorders listed in §C(11)—(52) of this regulation;</text> </paragraph> <paragraph num="(f)"> <text>IRT/IRT (immunoreactive trypsinogen/immuno-reactive trypsinogen) when testing for cystic fibrosis, which is the disorder listed in §C(53) of this regulation; and</text> </paragraph> <paragraph num="(g)"> <text>Real time polymerase chain reaction method when testing for severe combined immunodeficiency, which is listed in §C(54) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A permittee shall have 60 days from the amendment's effective date to comply with any amendment made by the Secretary to §D of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Screening Test Blood-Spot Specimens — Collection and Test Requisition."> <paragraph num="A."> <text>Blood-Spot Specimen Collection.</text> <paragraph num="(1)"> <text>A person shall collect a newborn infant’s blood-spot specimen for testing under this chapter by using only the special blood-spot specimen collection test requisition card provided by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall provide the special blood-spot specimen collection test requisition card to the:</text> <paragraph num="(a)"> <text>Individual in charge of a birthing facility or the individual’s designated representative; or</text> </paragraph> <paragraph num="(b)"> <text>Home birth attendant.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall collect a blood-spot specimen consisting of heel-stick whole blood obtained:</text> <paragraph num="(a)"> <text>When a newborn infant is 24 to 48 hours old;</text> </paragraph> <paragraph num="(b)"> <text>On a blood-spot specimen collection test requisition card provided by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>As set forth in Regulation .14 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Blood-Spot Specimen Collection Test Requisition Card Information. An individual shall record the following information as specified on the Department-supplied blood-spot specimen collection test requisition card:</text> <paragraph num="(1)"> <text>Newborn infant information, including:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Date of birth;</text> </paragraph> <paragraph num="(c)"> <text>Time of birth;</text> </paragraph> <paragraph num="(d)"> <text>Current weight;</text> </paragraph> <paragraph num="(e)"> <text>Gender;</text> </paragraph> <paragraph num="(f)"> <text>Race;</text> </paragraph> <paragraph num="(g)"> <text>Gestational age;</text> </paragraph> <paragraph num="(h)"> <text>Birthing facility identification, including the:</text> <paragraph num="(i)"> <text>Facility name;</text> </paragraph> <paragraph num="(ii)"> <text>Facility street address, city, state, and zip code; and</text> </paragraph> <paragraph num="(iii)"> <text>Newborn infant's medical record or chart number;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Date and time of first feeding;</text> </paragraph> <paragraph num="(j)"> <text>Type of feeding, such as:</text> <paragraph num="(i)"> <text>Breast;</text> </paragraph> <paragraph num="(ii)"> <text>Lactose-containing formula; or</text> </paragraph> <paragraph num="(iii)"> <text>Formula containing no lactose;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Transfusion history, including transfusion date and time;</text> </paragraph> <paragraph num="(l)"> <text>General health status of the newborn infant; and</text> </paragraph> <paragraph num="(m)"> <text>The total protein and calorie intake for any newborn infant in a neonatal intensive care setting;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Blood-spot specimen information, including:</text> <paragraph num="(a)"> <text>Date of collection;</text> </paragraph> <paragraph num="(b)"> <text>Time of collection; and</text> </paragraph> <paragraph num="(c)"> <text>Initials or other identifier of the individual who collected the blood-spot specimen;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Mother or guardian information, including:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Street address, city, state, and zip code; and</text> </paragraph> <paragraph num="(c)"> <text>Telephone number where the mother or guardian may be reached;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Information on the pediatrician or attending physician who will be following the newborn infant, including the physician's:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Street address, city, state, and zip code; and</text> </paragraph> <paragraph num="(c)"> <text>Telephone number; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Other information that can affect the test results or the interpretation of the test results when applicable, such as that antibiotics were administered to the:</text> <paragraph num="(a)"> <text>Mother; or</text> </paragraph> <paragraph num="(b)"> <text>Newborn infant.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements."> <paragraph num="A."> <text>Standard Operating Procedure. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to:</text> <paragraph num="(1)"> <text>Ensure and maintain blood-spot specimen integrity, quality, and acceptability;</text> </paragraph> <paragraph num="(2)"> <text>Ensure proper:</text> <paragraph num="(a)"> <text>Site preparation and cleaning;</text> </paragraph> <paragraph num="(b)"> <text>Performance of the heel stick puncture; and</text> </paragraph> <paragraph num="(c)"> <text>Application of whole blood to the collection test requisition card;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Identify precautions against:</text> <paragraph num="(a)"> <text>Milking or squeezing the blood-spot specimen collection site;</text> </paragraph> <paragraph num="(b)"> <text>Layering successive drops of blood on the same circle on the blood-spot specimen collection test requisition card;</text> </paragraph> <paragraph num="(c)"> <text>Filling the circles on both sides of the filter paper;</text> </paragraph> <paragraph num="(d)"> <text>Touching or smearing a blood-spot specimen before it is fully air-dried;</text> </paragraph> <paragraph num="(e)"> <text>Scratching or abrading the blood-spot specimen;</text> </paragraph> <paragraph num="(f)"> <text>Not allowing a blood-spot specimen to dry thoroughly before sending the blood-spot specimen collection test requisition card to a laboratory; and</text> </paragraph> <paragraph num="(g)"> <text>Damaging, stretching, or wrinkling the filter paper before, during or after blood-spot specimen collection;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Recognize unsatisfactory blood-spot specimens; and</text> </paragraph> <paragraph num="(5)"> <text>Handle and temporarily store a blood-spot specimen collection test requisition card, including the procedures and techniques for:</text> <paragraph num="(a)"> <text>Drying blood-spot specimens;</text> </paragraph> <paragraph num="(b)"> <text>Stacking of blood-spot specimen collection test requisition cards; and</text> </paragraph> <paragraph num="(c)"> <text>Temporarily storing blood-spot specimen collection test requisition cards.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Submission and Delivery Requirements. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall transport and deliver to the Department’s public health laboratory a newborn infant blood-spot specimen collection test requisition card using:</text> <paragraph num="(1)"> <text>An employee or private courier;</text> </paragraph> <paragraph num="(2)"> <text>A commercial carrier providing:</text> <paragraph num="(a)"> <text>Overnight express delivery; or</text> </paragraph> <paragraph num="(b)"> <text>Priority delivery;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A county or State operated courier system, where that service is available; or</text> </paragraph> <paragraph num="(4)"> <text>A combination of §B(1)—(3) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Test Blood-Spot Specimens — Use, Research, Storage, and Retention."> <paragraph num="A."> <text>Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter.</text> </paragraph> <paragraph num="B."> <text>Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the:</text> <paragraph num="(1)"> <text>Research is approved in writing by the Department's:</text> <paragraph num="(a)"> <text>Newborn Screening Program; and</text> </paragraph> <paragraph num="(b)"> <text>Institutional Review Board; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Researcher acknowledges in writing that the researcher will return all untested blood-spot specimens to the Department’s public health laboratory within 6 months of completing the approved research.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Storage. A permittee or researcher shall store a newborn infant blood-spot specimen in a sealed, moisture-proof container at between 2ºC and 6ºC.</text> </paragraph> <paragraph num="D."> <text>Retention.</text> <paragraph num="(1)"> <text>A permittee shall:</text> <paragraph num="(a)"> <text>Retain a newborn infant’s gel, produced when testing for hemoglobin disorders, for at least 90 days after testing is complete; and</text> </paragraph> <paragraph num="(b)"> <text>Return to the State’s public health laboratory all untested blood-spot specimens received from the Department’s public health laboratory for supplemental or diagnostic testing within 90 days after testing is completed by the permittee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department’s public health laboratory shall retain and maintain for 25 years a newborn infant’s blood-spot specimen after the blood-spot specimen is received for screening, supplemental testing, or diagnostic testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Test Records — Retention."> <text>The Department’s public health laboratory shall retain and maintain electronically or as a hard copy for 25 years the:</text> <paragraph num="A."> <text>Top copy of the requisition portion of the blood-spot specimen collection test requisition card;</text> </paragraph> <paragraph num="B."> <text>All test results and reports;</text> </paragraph> <paragraph num="C."> <text>Electronic data bases; and</text> </paragraph> <paragraph num="D."> <text>Supporting documents that show how a reported test result was obtained and verified, including but not limited to:</text> <paragraph num="(1)"> <text>Quality control records;</text> </paragraph> <paragraph num="(2)"> <text>Instrument maintenance and repair records;</text> </paragraph> <paragraph num="(3)"> <text>Test reagent records; and</text> </paragraph> <paragraph num="(4)"> <text>Instrument and test system data.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Testing — First-Tier."> <paragraph num="A."> <text>The Department’s public health laboratory shall test, using first-tier tests, appropriately timed and collected blood-spot specimen of a newborn infant’s blood for the disorders listed in Regulation .12C of this chapter.</text> </paragraph> <paragraph num="B."> <text>Full-Term Healthy Newborn Infants.</text> <paragraph num="(1)"> <text>If a newborn infant is born at term and is healthy, the Department’s public health laboratory shall conduct a:</text> <paragraph num="(a)"> <text>First screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the full-term healthy newborn infant is between 24 and 48 hours old; and</text> </paragraph> <paragraph num="(b)"> <text>Second screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 10 and 14 days old.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the first blood-spot specimen is collected when a full term healthy newborn infant is younger than 24 hours old, the Department’s public health laboratory shall conduct a:</text> <paragraph num="(a)"> <text>Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the newborn infant is between 24 hours and 7 days old; and</text> </paragraph> <paragraph num="(b)"> <text>Third screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 1 and 4 weeks old.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Premature or Ill Newborn Infant.</text> <paragraph num="(1)"> <text>If a newborn infant who is born prematurely or expected to be ill for more than 14 days was younger than 24 hours old when the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct a:</text> <paragraph num="(a)"> <text>Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter when the newborn infant is between 24 hours and 3 days old; and</text> </paragraph> <paragraph num="(b)"> <text>Third screening using first-tier tests when the newborn infant is between 7 days and 14 days old to screen for:</text> <paragraph num="(i)"> <text>Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter;</text> </paragraph> <paragraph num="(iii)"> <text>Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and</text> </paragraph> <paragraph num="(iv)"> <text>Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a newborn infant who is born prematurely or expected to be ill for more than 14 days was 24 hours old or older at the time the newborn infant’s blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall perform a second screening to screen for:</text> <paragraph num="(a)"> <text>Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a newborn infant was transfused before the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct, in addition to any other screenings specified in §B(1) and (2) of this regulation, a fourth screening using first-tier tests on a blood-spot specimen collected 4 months after a newborn infant’s last transfusion to screen for:</text> <paragraph num="(a)"> <text>Hemoglobin as specified in Regulation .12C(7)—(10) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Biotinidase as specified in Regulation .12C(1) of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Galactose-1-P-uridyl-1-transferase as specified in Regulation .12C(3) of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Testing — Second-Tier and Supplemental."> <paragraph num="A."> <text>When a test request is made by an individual authorized to request a laboratory test, as set out in COMAR 10.10.06.02:</text> <paragraph num="(1)"> <text>A permittee other than the Department's public health laboratory may perform a second-tier or supplemental test; and</text> </paragraph> <paragraph num="(2)"> <text>The Department's public health laboratory may perform a second-tier test.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A permittee:</text> <paragraph num="(1)"> <text>May not contract out, subcontract, or otherwise transfer supplemental or second-tier testing to another laboratory that does not hold a Maryland permit in the discipline of diagnostic and supplemental testing for hereditary and congenital disorders in newborns;</text> </paragraph> <paragraph num="(2)"> <text>Shall complete a second-tier or supplemental test on a blood-spot specimen within 3 working days after the blood-spot specimen arrives at the laboratory; and</text> </paragraph> <paragraph num="(3)"> <text>Shall report the results of a second-tier or supplemental screening test as required in Regulations .23 and .24 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Proficiency and Competency Testing for Newborn Screening Tests."> <text>A permittee shall:</text> <paragraph num="A."> <text>Meet all requirements set forth in COMAR 10.10.05;</text> </paragraph> <paragraph num="B."> <text>Successfully participate in one or more approved proficiency testing programs that cover all first-tier, second-tier, and supplementary tests offered or performed;</text> </paragraph> <paragraph num="C."> <text>Evaluate and document performance, semiannually during the first year of testing and annually thereafter, of all individuals responsible for testing; and</text> </paragraph> <paragraph num="D."> <text>In addition to the proficiency testing requirement in §A of this regulation, participate in the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Quality Control."> <paragraph num="A."> <text>Quality Control Program.</text> <paragraph num="(1)"> <text>A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports.</text> </paragraph> <paragraph num="(2)"> <text>A permittee's quality control program shall:</text> <paragraph num="(a)"> <text>Cover all tests, methods, and procedures performed by the laboratory; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the standards and requirements set forth in this chapter and COMAR 10.10.06.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A permittee's quality control procedures and practices shall include, but are not limited to, the use of:</text> <paragraph num="(a)"> <text>Analyses of reference materials to ensure the reproducibility and accuracy of test results;</text> </paragraph> <paragraph num="(b)"> <text>Systems to ensure proper functioning of instruments, equipment, reagents, and performance of laboratory personnel;</text> </paragraph> <paragraph num="(c)"> <text>Valid reagents, equipment, calibration, and systematic procedural checks;</text> </paragraph> <paragraph num="(d)"> <text>A system that ensures timely and pertinent error detection and correction for the review and reporting of test results; and</text> </paragraph> <paragraph num="(e)"> <text>Quality control materials from the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Adequacy of Methods and Equipment. To ensure the adequacy of test methods, test systems, and equipment, a permittee shall:</text> <paragraph num="(1)"> <text>Employ methods, test systems, and equipment that provide accurate and reliable test results and reports;</text> </paragraph> <paragraph num="(2)"> <text>Have sufficient and suitable equipment and instruments to perform the type and volume of tests offered and performed by the laboratory;</text> </paragraph> <paragraph num="(3)"> <text>Perform tests in a manner that provides accurate and reliable test results;</text> </paragraph> <paragraph num="(4)"> <text>Monitor test methods, instruments, and testing systems, where applicable, for the following performance characteristics:</text> <paragraph num="(a)"> <text>Method, instrument, and test system detection limits and cutoff levels;</text> </paragraph> <paragraph num="(b)"> <text>Precision;</text> </paragraph> <paragraph num="(c)"> <text>Accuracy;</text> </paragraph> <paragraph num="(d)"> <text>Specificity;</text> </paragraph> <paragraph num="(e)"> <text>Sensitivity;</text> </paragraph> <paragraph num="(f)"> <text>Interferences; and</text> </paragraph> <paragraph num="(g)"> <text>Other related test variables that affect test results; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have adequate quality control systems and procedures in place to:</text> <paragraph num="(a)"> <text>Obtain and verify a statistically valid number of counts or measurement levels to give accurate and reliable test results for an analytical instrument, each day an instrument is used for testing; and</text> </paragraph> <paragraph num="(b)"> <text>Report results:</text> <paragraph num="(i)"> <text>As set forth in COMAR 10.10.06.04;</text> </paragraph> <paragraph num="(ii)"> <text>As set forth in 42 CFR §493.1291; and</text> </paragraph> <paragraph num="(iii)"> <text>Within the time frames required by this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Supplies, Reagents, and Materials.</text> <paragraph num="(1)"> <text>A permittee shall ensure that supplies, reagents, and other materials used in the collected, handling, testing, and storing of newborn blood-spot specimens are stored, labeled, checked for proper reactivity, and used according to the provisions of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A permittee shall:</text> <paragraph num="(a)"> <text>Label laboratory supplies and materials used in the testing process, including reagents, solutions, controls, and calibrators to indicate the:</text> <paragraph num="(i)"> <text>Identity of reagents, solutions, controls, and calibrators;</text> </paragraph> <paragraph num="(ii)"> <text>Strength or concentration;</text> </paragraph> <paragraph num="(iii)"> <text>Storage requirements;</text> </paragraph> <paragraph num="(iv)"> <text>Preparation and expiration date;</text> </paragraph> <paragraph num="(v)"> <text>Identity of the preparer; and</text> </paragraph> <paragraph num="(vi)"> <text>Other pertinent information that affects test performance;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Store laboratory materials in the manner recommended by the manufacturer;</text> </paragraph> <paragraph num="(c)"> <text>Test representative samples of each lot of materials used for or in the process of testing blood-spot specimens on a regularly scheduled basis to determine that each lot of test material is capable of performing as required; and</text> </paragraph> <paragraph num="(d)"> <text>Use supplies, reagents, kits, test systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A permittee may not use supplies, reagents, kits, test systems, or other materials in the testing process that have:</text> <paragraph num="(a)"> <text>Exceeded the materials' established expiration dates;</text> </paragraph> <paragraph num="(b)"> <text>Substandard reactivity; or</text> </paragraph> <paragraph num="(c)"> <text>Deteriorated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Quality Assessment and Quality Assurance."> <paragraph num="A."> <text>A permittee shall:</text> <paragraph num="(1)"> <text>Establish and follow a written quality assessment plan that covers all phases of the testing process;</text> </paragraph> <paragraph num="(2)"> <text>Meet the applicable quality assurance requirements of COMAR 10.10.06; and</text> </paragraph> <paragraph num="(3)"> <text>Have an accessioning mechanism or system that:</text> <paragraph num="(a)"> <text>Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and</text> </paragraph> <paragraph num="(b)"> <text>Identifies a specific analyte that requires retesting when a newborn infant's prior screening test results for that analyte are abnormal or border-line abnormal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A permittee may not test a blood-spot specimen exhibiting:</text> <paragraph num="(1)"> <text>Blood that did not saturate the filter paper;</text> </paragraph> <paragraph num="(2)"> <text>A circle containing no blood;</text> </paragraph> <paragraph num="(3)"> <text>A blood clot or tissue on the surface of the blood;</text> </paragraph> <paragraph num="(4)"> <text>A circle over-saturated with blood showing dark areas in the circle or at the perimeter;</text> </paragraph> <paragraph num="(5)"> <text>Blood that appears layered or clotted; or</text> </paragraph> <paragraph num="(6)"> <text>Serum rings or blood that appears diluted, discolored, or contaminated.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A permittee may not test a blood-spot specimen:</text> <paragraph num="(1)"> <text>Collected more than 10 days before the screening test is to be started;</text> </paragraph> <paragraph num="(2)"> <text>That is unaccompanied by information necessary for the testing to be meaningful, including the:</text> <paragraph num="(a)"> <text>Age of the newborn infant;</text> </paragraph> <paragraph num="(b)"> <text>Identification of the newborn infant;</text> </paragraph> <paragraph num="(c)"> <text>Date and time of blood-spot specimen collection;</text> </paragraph> <paragraph num="(d)"> <text>Date and time of birth;</text> </paragraph> <paragraph num="(e)"> <text>Newborn infant's weight; and</text> </paragraph> <paragraph num="(f)"> <text>Date and time of a newborn infant's first feeding;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or</text> </paragraph> <paragraph num="(4)"> <text>If the newborn infant was younger than 24 hours old or the newborn's age was unknown at the time of collection and the requested screening test is for:</text> <paragraph num="(a)"> <text>Congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Thyroxine or thyroid stimulating hormone as specified in Regulation .12C(4) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail:</text> <paragraph num="(1)"> <text>That the blood-spot specimen cannot be tested; and</text> </paragraph> <paragraph num="(2)"> <text>To submit another blood-spot specimen as soon as possible.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall:</text> <paragraph num="(1)"> <text>Give prompt notice of the erroneous or questionable patient test result to the:</text> <paragraph num="(a)"> <text>Person who requested that the test be performed;</text> </paragraph> <paragraph num="(b)"> <text>Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; and</text> </paragraph> <paragraph num="(c)"> <text>Follow-Up Unit;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide corrected reports to the persons notified in §E of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Maintain duplicates of both the original report and the corrected report;</text> </paragraph> <paragraph num="(4)"> <text>Conduct a quality assessment of all phases of the testing process to determine the cause of the erroneous or questionable test result;</text> </paragraph> <paragraph num="(5)"> <text>Take the necessary remedial or corrective action to prevent recurrence of the problem; and</text> </paragraph> <paragraph num="(6)"> <text>Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:</text> <paragraph num="(a)"> <text>Notifying a parent or guardian of the newborn infant of the erroneous or questionable result;</text> </paragraph> <paragraph num="(b)"> <text>Retesting the same blood-spot specimen;</text> </paragraph> <paragraph num="(c)"> <text>Testing a new blood-spot specimen; and</text> </paragraph> <paragraph num="(d)"> <text>Retesting the same blood-spot specimen and testing a new blood-spot specimen.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Quality Assurance — Continuity of Operations and Disaster Recovery Plan."> <text>A permittee shall develop, implement, and maintain written continuity of operations and disaster recovery plans that ensure the continuous performance of essential functions and operations:</text> <paragraph num="A."> <text>During an emergency; or</text> </paragraph> <paragraph num="B."> <text>When the laboratory temporarily can no longer meet the requirements and standards set forth in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Reporting Test Results."> <paragraph num="A."> <text>All Test Results. For a newborn infant, a permittee shall:</text> <paragraph num="(1)"> <text>Report all first-tier, supplemental, and second-tier results to:</text> <paragraph num="(a)"> <text>The person who requested the test; and</text> </paragraph> <paragraph num="(b)"> <text>An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including:</text> <paragraph num="(i)"> <text>A physician specialist; and</text> </paragraph> <paragraph num="(ii)"> <text>Personnel in the Follow-Up Unit;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Report to the persons listed in §A(1) of this regulation within 3 working days after the laboratory obtains the blood-spot specimen, all test results that are within normal limits;</text> </paragraph> <paragraph num="(3)"> <text>Report to a person requesting a second or subsequent screening the test results from the newborn infant's prior screening if not previously reported to the person;</text> </paragraph> <paragraph num="(4)"> <text>Include with each report the following information:</text> <paragraph num="(a)"> <text>Date the blood-spot specimen was received in the laboratory;</text> </paragraph> <paragraph num="(b)"> <text>Date of the report; and</text> </paragraph> <paragraph num="(c)"> <text>Cut-off level for each reported analyte; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Report all abnormal test results to the Follow-Up Unit on the same day that a test result is obtained and reviewed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific Test results. A permittee may not report a test result as being within normal limits for:</text> <paragraph num="(1)"> <text>Amino acid levels for disorders specified in Regulation .12C(11)—(24) of this chapter and for a total galactose level for galactosemia as specified in Regulation .12C(3) of this chapter if:</text> <paragraph num="(a)"> <text>A newborn infant was not on milk or formula feeding at least 24 hours before the blood-spot specimen was collected; or</text> </paragraph> <paragraph num="(b)"> <text>The time of milk or formula feeding is unknown; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>17-hydroxy progesterone results for congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter and thyroxine and thyroid stimulating hormone for hypothyroidism as specified in Regulation .12C(4) of this chapter if the blood-spot specimen was collected when the newborn infant was:</text> <paragraph num="(a)"> <text>Younger than 24 hours old; or</text> </paragraph> <paragraph num="(b)"> <text>Of unknown age.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Reporting Abnormal Test Results to the Follow-Up Unit."> <paragraph num="A."> <text>Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by:</text> <paragraph num="(1)"> <text>Telephoning and personally speaking to an individual in the Follow-Up Unit;</text> </paragraph> <paragraph num="(2)"> <text>Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and</text> </paragraph> <paragraph num="(3)"> <text>Following up a telephonic report within 24 hours with a report by facsimile or electronic mail to the Follow-Up Unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Verification Requirement. A permittee shall contact the Follow-Up Unit by telephone at least once every 6 months to ensure that the permittee is able to meet the requirements in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>Reporting Requirements; General. A permittee shall provide with each abnormal result, where applicable, the:</text> <paragraph num="(1)"> <text>Identity or name of each analyte measured;</text> </paragraph> <paragraph num="(2)"> <text>Measured numerical concentration or range of:</text> <paragraph num="(a)"> <text>Each analyte measured; and</text> </paragraph> <paragraph num="(b)"> <text>All related analytes measured;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Value of any relevant ratios used to determine abnormality;</text> </paragraph> <paragraph num="(4)"> <text>Postnatal age of the newborn infant;</text> </paragraph> <paragraph num="(5)"> <text>Appropriate gestational age/birth weight control range;</text> </paragraph> <paragraph num="(6)"> <text>Cut-off level for the analyte of a hereditary or congenital disorder; and</text> </paragraph> <paragraph num="(7)"> <text>Measure of the degree of abnormality of the test result.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reporting Requirements; Sickle Cell Disease Hemoglobin. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)—(10) of this chapter for sickle cell disease in terminology that includes:</text> <paragraph num="(1)"> <text>The alleles present in decreasing quantitative order; and</text> </paragraph> <paragraph num="(2)"> <text>Specifying trait states and possible disease states for at least the following alleles:</text> <paragraph num="(a)"> <text>Hemoglobin C;</text> </paragraph> <paragraph num="(b)"> <text>Hemoglobin D;</text> </paragraph> <paragraph num="(c)"> <text>Hemoglobin E;</text> </paragraph> <paragraph num="(d)"> <text>Hemoglobin G;</text> </paragraph> <paragraph num="(e)"> <text>Hemoglobin O; and</text> </paragraph> <paragraph num="(f)"> <text>Hemoglobin S.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Reporting System and Communication Software."> <text>A permittee shall:</text> <paragraph num="A."> <text>Have available and use a reliable and accurate electronic information system that is capable of collecting, compiling, transferring, and communicating all normal and abnormal test results to the Follow-Up Unit; and</text> </paragraph> <paragraph num="B."> <text>Provide the Follow-Up Unit, where applicable, with:</text> <paragraph num="(1)"> <text>The necessary information system and electronic communications software or interface to be used by the Follow-Up Unit to receive from the permittee the newborn screening test results and reports required in this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Software programming assistance to ensure that the:</text> <paragraph num="(a)"> <text>Permittee's data transmitted to the Follow-Up Unit is accurate and timely; and</text> </paragraph> <paragraph num="(b)"> <text>The Follow-Up Unit's information system maintains compatibility with the permittee's information system.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Availability of Statistical and Scientific Data."> <paragraph num="A."> <text>Statistical Reports. The State’s public health laboratory, the Follow-Up Unit, or both, on request, shall provide Newborn Screening Program statistical data for official State and national reports to:</text> <paragraph num="(1)"> <text>The Council;</text> </paragraph> <paragraph num="(2)"> <text>The Department's Office of Genetics and Children with Special Healthcare Needs; and</text> </paragraph> <paragraph num="(3)"> <text>State and federal agencies that use test results and statistics for the care and treatment of newborn infants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Research Investigations. The Laboratories Administration, the Follow-Up Unit, or both, may participate in research investigations approved by the Department's Institutional Review Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Sanctions."> <paragraph num="A."> <text>Due to the life-threatening nature and effect of errors in newborn screening testing, the Secretary may order summarily the suspension of a permit if the Secretary finds that the public health, safety, or welfare imperatively requires emergency action, including but not limited to, if a permittee has:</text> <paragraph num="(1)"> <text>Failed to report a newborn infant's abnormal test result as required in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Falsified a document submitted to the Department, including but not limited to a:</text> <paragraph num="(a)"> <text>Newborn infant screening test report; or</text> </paragraph> <paragraph num="(b)"> <text>Quality control or quality assurance report; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failed to provide a corrected or amended test report if the permittee has reported an erroneous or questionable test result.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary summarily suspends a permit as provided in §A of this regulation, the Secretary shall promptly give the permittee:</text> <paragraph num="(1)"> <text>Written notice of the suspension, the finding, and the reasons that support the finding; and</text> </paragraph> <paragraph num="(2)"> <text>An opportunity to be heard.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may impose a directed plan of correction, limit testing, deny a permit renewal, or suspend or revoke a current permit if a permittee has:</text> <paragraph num="(1)"> <text>Failed to meet the applicable standards and requirements set forth in:</text> <paragraph num="(a)"> <text>Health-General Article, Title 17, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.10.01—.08 and this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Conducted research on newborn infant blood-spot specimens within the Newborn Screening Program’s approval as required in Regulation .15 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Failed to pay the Department any fee required under this subtitle.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to sanctions provided in §§A and C of this regulation, the Secretary may:</text> <paragraph num="(1)"> <text>Impose any sanction provided in COMAR 10.10.08; and</text> </paragraph> <paragraph num="(2)"> <text>Refer a person for criminal prosecution, as provided at Health-General Article, §17-216, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person may have a hearing on the imposition of a sanction and an opportunity to respond to a sanction imposed by the Secretary under this regulation as set forth in COMAR 10.10.08.03.</text> </paragraph> <paragraph num="F."> <text>Except as provided in §§A and B of this regulation, before the Secretary denies, suspends, or revokes a permit, the Secretary shall give the applicant or permittee notice of the action and an opportunity to be heard.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-101—13-103, 13-108—13-112, 13-601—13-605, 17-201—17-206, 17-210, 17-211, 17-215, and 17-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01— .27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective July 1, 2012 (39:15 Md. R. 962); amended permanently effective August 20, 2012 (39:16 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective April 27, 2015 (42:8 Md. R. 608); April 14, 2025 (52:7 Md. R. 321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, C amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, D amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C amended effective April 24, 2017 (44:8 Md. R. 404)</annotation> </annotations> </chapter> </subtitle> <subtitle num="11" heading="Maternal and Child Health"> <chapter num="01" heading="Identification of Infants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations affect all institutions or related facilities, as defined in Regulation .02 of this chapter, that deliver a newborn infant from its mother.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Born” means the complete expulsion or extraction of a product of human conception from its mother, regardless of the period of gestation, if, after the expulsion or extraction, it breathes or shows any other evidence of life, such as heartbeat, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether or not the umbilical cord is cut or the placenta is attached.</text> </paragraph> <paragraph num="(2)"> <text>“Cord blood sampling” means the taking of a sample of a newborn infant's blood from the infant's umbilical cord.</text> </paragraph> <paragraph num="(3)"> <text>“Footprinting” means the taking of an ink or other type of impression of the skin patterns located on the sole of the newborn infant's foot.</text> </paragraph> <paragraph num="(4)"> <text>“Institution” means:</text> <paragraph num="(a)"> <text>A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A freestanding birthing center as defined in Health-General Article, §19-1101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Any other facility that delivers an infant from its mother.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Identification of Newborn Infants — Mandatory Procedure."> <paragraph num="A."> <text>An institution shall perform the infant identification procedures described in this regulation:</text> <paragraph num="(1)"> <text>Immediately after the birth of the infant; and</text> </paragraph> <paragraph num="(2)"> <text>Before the mother and infant are separated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual employed by the institution who attends the birth shall securely attach matching identification bands to the wrists of the mother and infant. An additional matching band may be attached the infant's father or another individual designated by the infant's mother.</text> </paragraph> <paragraph num="C."> <text>The matching identification bands shall include:</text> <paragraph num="(1)"> <text>The mother's name;</text> </paragraph> <paragraph num="(2)"> <text>The same identification number for:</text> <paragraph num="(a)"> <text>The infant;</text> </paragraph> <paragraph num="(b)"> <text>The mother; and</text> </paragraph> <paragraph num="(c)"> <text>If applicable, the father or any other designated person;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The infant's gender;</text> </paragraph> <paragraph num="(4)"> <text>The date and time of birth; and</text> </paragraph> <paragraph num="(5)"> <text>Any other information specified by the institution's policy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In the case of multiple births:</text> <paragraph num="(1)"> <text>The identification band for each infant shall also include the infant's birth order indicated either alphabetically such as by A, B, C or numerically such as by 1, 2, 3; and</text> </paragraph> <paragraph num="(2)"> <text>A band corresponding to each infant shall be attached to the mother.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Any unused band shall be:</text> <paragraph num="(1)"> <text>Attached to the mother;</text> </paragraph> <paragraph num="(2)"> <text>Stapled to the mother's chart; or</text> </paragraph> <paragraph num="(3)"> <text>Disposed of in a secure disposal box.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An individual employed by the institution shall check the birth record and identification bands for accuracy before the mother or infant leaves the delivery room.</text> </paragraph> <paragraph num="G."> <text>Each institution shall implement policies requiring personnel to check to ensure that the identification bands of a mother and her infant match:</text> <paragraph num="(1)"> <text>Each time the infant is taken to the mother while at the institution; and</text> </paragraph> <paragraph num="(2)"> <text>At the time of the discharge of the mother and infant from the institution.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Identification of Newborn Infants — Additional Procedures Permitted."> <paragraph num="A."> <text>An institution may perform additional identification procedures on an infant before the infant leaves the delivery room. These methods do not link mother and infant, but may be useful in establishing the identity of an infant, and include:</text> <paragraph num="(1)"> <text>Cord blood sampling;</text> </paragraph> <paragraph num="(2)"> <text>Footprinting;</text> </paragraph> <paragraph num="(3)"> <text>Taking a color photograph of the infant;</text> </paragraph> <paragraph num="(4)"> <text>Physically assessing the infant and documenting of any distinguishing features; or</text> </paragraph> <paragraph num="(5)"> <text>Another procedure proposed by the institution to the Secretary for approval that provides at least equivalent identification.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An institution proposing to the Secretary another procedure to identify newborn infants shall include in the proposal at least the following information:</text> <paragraph num="(1)"> <text>Method of collection;</text> </paragraph> <paragraph num="(2)"> <text>Methods of storage;</text> </paragraph> <paragraph num="(3)"> <text>Specimen labeling;</text> </paragraph> <paragraph num="(4)"> <text>Specimen security and chain of custody;</text> </paragraph> <paragraph num="(5)"> <text>Testing method, or methods to be used;</text> </paragraph> <paragraph num="(6)"> <text>Circumstances for testing;</text> </paragraph> <paragraph num="(7)"> <text>Quality assurance of tests;</text> </paragraph> <paragraph num="(8)"> <text>Confidentiality issues;</text> </paragraph> <paragraph num="(9)"> <text>Protection against unauthorized access; and</text> </paragraph> <paragraph num="(10)"> <text>Record and documentation system.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Identification of Policies and Procedures. An institution shall:</text> <paragraph num="(1)"> <text>Develop policies and methods for conducting each additional infant identification procedure under this regulation, and each procedure shall be documented with at least the following information:</text> <paragraph num="(a)"> <text>Mother's name;</text> </paragraph> <paragraph num="(b)"> <text>Mother's patient identification number;</text> </paragraph> <paragraph num="(c)"> <text>Date of birth;</text> </paragraph> <paragraph num="(d)"> <text>Gender of the newborn infant;</text> </paragraph> <paragraph num="(e)"> <text>Birth order if a multiple birth; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Designate and train personnel responsible for performing newborn infant identification procedures.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Verification.</text> <paragraph num="(1)"> <text>An institution shall verify that the identification procedure was performed by completing a form supplied by the institution or related facility. Information on the form shall include, but need not be limited to the:</text> <paragraph num="(a)"> <text>Type of identification procedures performed;</text> </paragraph> <paragraph num="(b)"> <text>Date and time the identification procedure was performed; and</text> </paragraph> <paragraph num="(c)"> <text>Name of personnel performing the identification procedure.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An institution shall enter this form, which lists at least the information required in §D(1)(a), (b), and (c), of this regulation, into the infant's institutional medical record and maintain it as part of the infant's overall institutional record.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Retention. An institution shall retain any identifying material (blood sample or footprint) for at least 10 days or until the newborn is discharged, whichever comes later.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 20-401, and 20-402, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Subtitle 11 Midwifery effective February 1, 1957; repealed effective July 12, 1987 (14:14 Md. R. 1572)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted effective December 25, 1989 (16:25 Md. R. 2710)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 6, 2009 (36:7 Md. R. 524)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 30, 2026 (53:6 Md. R. 291)</annotation> </annotations> </chapter> <chapter num="02" heading="Early Hearing Detection and Intervention Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The Early Hearing Detection and Intervention Program shall provide for the universal hearing screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills. The Program shall identify newborns and infants who have a permanent hearing status that affects speech-language skills as early as possible.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter requires the screening of all newborns and infants born in Maryland and follow-up for those who have, or are at risk for developing, a permanent hearing status that affects speech-language skills.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Alternative birthing site” means any site of birth other than a hospital.</text> </paragraph> <paragraph num="(2)"> <text>“Appropriate services” mean any necessary audiological, medical, developmental, speech-language, sign language, psychosocial, educational, or intervention services required in the follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills.</text> </paragraph> <paragraph num="(3)"> <text>“At risk for developing a permanent hearing status that affects speech-language skills” means an infant identified as having any risk factor listed in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Audiological assessment” means testing to determine status of the auditory mechanism.</text> </paragraph> <paragraph num="(5)"> <text>“Audiologist” means an individual licensed to practice audiology by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists.</text> </paragraph> <paragraph num="(6)"> <text>“Birthing hospital” means a medical facility licensed by the Department which provides obstetrical services.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Department database” means the computer data management system used to gather and maintain program data.</text> </paragraph> <paragraph num="(9)"> <text>“Early Hearing Detection and Intervention Advisory Council (Advisory Council)” means the 12-member advisory council appointed by the Secretary to provide advice and consultation to the Department concerning the Early Hearing Detection and Intervention Program.</text> </paragraph> <paragraph num="(10)"> <text>“Early intervention system” means the total effort in the State, for children from birth to 5 years of age, to meet the needs of eligible children and the children’s families, including the efforts of the Maryland Early Hearing Detection and Intervention Program.</text> </paragraph> <paragraph num="(11)"> <text>“Hearing screening” means behavioral, electrophysiological, or other procedures used to identify newborns and infants in need of diagnostic audiological assessment.</text> </paragraph> <paragraph num="(12)"> <text>“Hearing status” means the state of an individual’s ability to perceive sound, based on audiological assessment.</text> </paragraph> <paragraph num="(13)"> <text>“Infant” means a Maryland resident who is younger than 1 year old.</text> </paragraph> <paragraph num="(14)"> <text>“Infant with a permanent change in hearing status that affects speech-language skills” means an infant who has a status that is an atypical function of the auditory system or any nontransient hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification.</text> </paragraph> <paragraph num="(15)"> <text>“Local education agency” means a public board of education and public school system legally constituted to administer and direct education and programs of education in the public elementary or secondary schools, including early childhood from birth through the end of high school or their equivalent, in Baltimore City and the 23 counties in Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Local health department” means the official public health agency of the local political subdivision affiliated with the Department.</text> </paragraph> <paragraph num="(17)"> <text>“Maryland Infants and Toddlers Program” means the program within the Maryland State Department of Education’s Division of Special Education/Early Intervention Services that provides early intervention services for children under Part C of the Individuals with Disabilities Education Act.</text> </paragraph> <paragraph num="(18)"> <text>“Newborn” means a child up to 29 days old who is born in the State.</text> </paragraph> <paragraph num="(19)"> <text>“Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child’s welfare, or a person appointed as the surrogate parent as defined in COMAR 13A.05.01.</text> </paragraph> <paragraph num="(20)"> <text>“Primary care provider” means a licensed practitioner who is the primary coordinator of care for the individual, whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services.</text> </paragraph> <paragraph num="(21)"> <text>“Program” means the Early Hearing Detection and Intervention Program established by the Secretary that provides for the universal screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills.</text> </paragraph> <paragraph num="(22)"> <text>“Referral” means directing the newborn or infant at risk for developing a permanent hearing status that affects speech-language skills and the newborn or infant’s parent or guardian to a professional for diagnostic audiological assessment or other appropriate services, or both.</text> </paragraph> <paragraph num="(23)"> <text>“Risk factors” means indicators that are associated with permanent congenital, delayed-onset, or progression to a hearing status that affects speech-language skills in childhood.</text> </paragraph> <paragraph num="(24)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee.</text> </paragraph> <paragraph num="(25)"> <text>“Telephone resource line” means toll-free telephone access to the Program inside Maryland through live voice or recorded message that is compatible with telecommunication relay services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="High Risk Factors."> <text>Any of the following high risk factors are considered relevant in determining the possibility of a newborn or infant developing a permanent hearing status that affects speech-language skills under this chapter:</text> <paragraph num="A."> <text>Caregiver concern regarding hearing, speech, language, or developmental delay;</text> </paragraph> <paragraph num="B."> <text>Family history of a permanent hearing status that affects speech-language skills occurring during childhood;</text> </paragraph> <paragraph num="C."> <text>Medical risk factors:</text> <paragraph num="(1)"> <text>Neonatal intensive care for more than 5 days;</text> </paragraph> <paragraph num="(2)"> <text>Extracorporeal membrane oxygenation;</text> </paragraph> <paragraph num="(3)"> <text>Assisted ventilation;</text> </paragraph> <paragraph num="(4)"> <text>Hyperbilirubinemia that requires exchange transfusion of the blood;</text> </paragraph> <paragraph num="(5)"> <text>Exposure to ototoxic medications, such as gentimycin and tobramycin; and</text> </paragraph> <paragraph num="(6)"> <text>Exposure to loop diuretic medications, such as furosemide and lasix;</text> </paragraph> </paragraph> <paragraph num="D."> <text>In utero infections, such as cytomegalovirus, herpes, rubella, syphilis, and toxoplasmosis;</text> </paragraph> <paragraph num="E."> <text>Craniofacial anomalies;</text> </paragraph> <paragraph num="F."> <text>Physical findings associated with a permanent hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="G."> <text>Diagnosis of a syndrome associated with a congenital or progressive change in hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="H."> <text>Neurodegenerative disorders, including:</text> <paragraph num="(1)"> <text>Hunter syndrome; and</text> </paragraph> <paragraph num="(2)"> <text>Sensory motor neuropathies, such as Friedrich’s Ataxia and Charcot-Marie-Tooth disease;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Culture-positive postnatal infections associated with a permanent change in hearing status that affects speech-language skills, including bacterial and viral meningitis;</text> </paragraph> <paragraph num="J."> <text>Head trauma, including basal skull and temporal bone fracture, that require hospitalization; and</text> </paragraph> <paragraph num="K."> <text>Chemotherapy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Model System."> <text>The Department shall establish and maintain a model system to provide for the implementation of an early identification program and follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills and includes the following components:</text> <paragraph num="A."> <text>Educational materials;</text> </paragraph> <paragraph num="B."> <text>Telephone resource line;</text> </paragraph> <paragraph num="C."> <text>Department database to gather and maintain program data;</text> </paragraph> <paragraph num="D."> <text>A service referral directory;</text> </paragraph> <paragraph num="E."> <text>In-service training of hospitals, local health departments, and local education agencies;</text> </paragraph> <paragraph num="F."> <text>Referral to appropriate agency or professional for services;</text> </paragraph> <paragraph num="G."> <text>Program monitoring and review;</text> </paragraph> <paragraph num="H."> <text>Confidentiality of records and information in accordance with Health-General Article, §§4-101 and 4-301 — 4-309, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="I."> <text>Continuum of follow-up which includes:</text> <paragraph num="(1)"> <text>Contacting the primary care provider in writing or by telephone to verify the status of the infant;</text> </paragraph> <paragraph num="(2)"> <text>Contacting parents or guardians in writing or by telephone to facilitate referral for diagnostic audiological assessment and referral for appropriate services; and</text> </paragraph> <paragraph num="(3)"> <text>Interfacing with the single point of entry for the early intervention system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Early Hearing Detection and Intervention Advisory Council."> <text>The Advisory Council shall:</text> <paragraph num="A."> <text>Advise the Department on:</text> <paragraph num="(1)"> <text>The implementation of an early identification program and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="(2)"> <text>Setting of standards for the Program including procedures for hearing screening;</text> </paragraph> <paragraph num="(3)"> <text>Monitoring and reviewing of the Program; and</text> </paragraph> <paragraph num="(4)"> <text>Provision of quality assurance for the Program;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide consultation to the Department in the development of the Program;</text> </paragraph> <paragraph num="C."> <text>Make recommendations for operation of the Program;</text> </paragraph> <paragraph num="D."> <text>Provide consultation to the Department in the maintenance of an educational program for families, professionals, and the public integrated with the Maryland Infants and Toddlers Program and local early intervention systems, including existing State and local education agency programs;</text> </paragraph> <paragraph num="E."> <text>Review any materials the Department may distribute to the public concerning newborns and infants who have a permanent hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="F."> <text>Meet annually with the Secretary or the Secretary’s designee; and</text> </paragraph> <paragraph num="G."> <text>Provide consultation to the Department in the adoption of rules and regulations necessary to implement the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Birthing Hospitals and Alternative Birthing Sites."> <text>For each infant delivered at the facility or site, birthing hospital staff and, in the cases of alternative birthing sites, the licensed professional attending the birth shall:</text> <paragraph num="A."> <text>Within 48 hours of delivery, enter demographic and birth event data into the Department database;</text> </paragraph> <paragraph num="B."> <text>Within 48 hours of discharge from care in the Department database:</text> <paragraph num="(1)"> <text>Document:</text> <paragraph num="(a)"> <text>The hearing screening test results; and</text> </paragraph> <paragraph num="(b)"> <text>Any known risk factors; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Identify and document:</text> <paragraph num="(a)"> <text>The infant’s primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>Any referrals made; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Provide to the family:</text> <paragraph num="(1)"> <text>Written documentation of the birth hearing screening results;</text> </paragraph> <paragraph num="(2)"> <text>Any identified risk factors; and</text> </paragraph> <paragraph num="(3)"> <text>Instructions for any recommended follow-up.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Procedures for Audiologists and Licensed Professionals Conducting Audiological Screening or Evaluations."> <paragraph num="A."> <text>An audiologist or a licensed professional who performs a hearing screening or audiological diagnostic evaluation on a child younger than 5 years old due to the presence of a risk factor as listed in Regulation .04 of this chapter or in follow-up to the birth hearing screening of a newborn or infant who did not receive or did not pass the birth hearing screening shall:</text> <paragraph num="(1)"> <text>Within 2 business days:</text> <paragraph num="(a)"> <text>Report the results of the screening or audiological diagnostic evaluation to the Program in the Department database;</text> </paragraph> <paragraph num="(b)"> <text>Document recommendations and referrals provided in the Department database; and</text> </paragraph> <paragraph num="(c)"> <text>Confirm or update the demographic information of the child or infant in the Department database; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 7 business days, notify the appropriate early intervention program at the Maryland State Department of Education of any child younger than 5 years old confirmed to have or strongly suspected of having a permanent hearing status of any type or degree as described in §B of this regulation which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A child younger than 5 years old is strongly suspected of having a permanent hearing status if evidence or clinical judgment exists which indicates that there is a high probability of a permanent hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Department Procedures."> <paragraph num="A."> <text>The Program shall:</text> <paragraph num="(1)"> <text>Implement the model system;</text> </paragraph> <paragraph num="(2)"> <text>Perform duties and responsibilities in accordance with the advice and consultation of the Advisory Council;</text> </paragraph> <paragraph num="(3)"> <text>Exercise independent judgment in the day-to-day operations of the Program;</text> </paragraph> <paragraph num="(4)"> <text>Develop Program processes in consultation with the Advisory Council;</text> </paragraph> <paragraph num="(5)"> <text>Conduct in-service training on Program procedures;</text> </paragraph> <paragraph num="(6)"> <text>Maintain a Department database to monitor infants at risk for developing a hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="(7)"> <text>Track infants identified as at risk for developing a permanent hearing status that affects speech-language skills for a period of 5 years;</text> </paragraph> <paragraph num="(8)"> <text>Maintain a service directory within the Department database;</text> </paragraph> <paragraph num="(9)"> <text>Assure operation of the telephone resource line;</text> </paragraph> <paragraph num="(10)"> <text>Facilitate referral for diagnostic audiological assessment and early intervention for infants who are at risk for developing a permanent hearing status that affects speech-language skills;</text> </paragraph> <paragraph num="(11)"> <text>Maintain records of the audiological assessment reports for infants at risk for developing a permanent hearing status that affects speech-language skills; and</text> </paragraph> <paragraph num="(12)"> <text>Interface with the single point of entry of the early intervention system.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary shall establish guidelines for the operation of the Advisory Council.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-601—13-605, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 20, 1992 (19:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.09 adopted effective June 22, 2015 (42:12 Md. R. 762)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 291)</annotation> </annotations> </chapter> <chapter num="03" heading="Children's Medical Services Program"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>In this chapter, the federal poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services, are incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Agency” means a legally incorporated body or governmental unit which provides services to disabled children or their families, or both.</text> </paragraph> <paragraph num="(2)"> <text>“Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription.</text> </paragraph> <paragraph num="(3)"> <text>“Appeal” means the process by which a child with special health care needs, as defined in §B(9) of this regulation, or the family on the child’s behalf, obtains a review of a decision, action, or lack of action on the part of the CMS Program or one of its designees.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means a child with special health care needs, as defined in §B(9) of this regulation, or the parent or guardian of a child, for whom a written application has been submitted to the CMS Program for services, but for whom eligibility has not yet been determined.</text> </paragraph> <paragraph num="(5)"> <text>“Authorized services” means that care which is approved by the CMS Program for an eligible child.</text> </paragraph> <paragraph num="(6)"> <text>“Care coordination services” means services to promote the effective and efficient utilization of resources to assure access to necessary comprehensive services.</text> </paragraph> <paragraph num="(7)"> <text>“Care management plan (CMP)” means a written document that lists recommendations for care as specified by a licensed and boarded provider.</text> </paragraph> <paragraph num="(8)"> <text>“Children’s Medical Services Program (CMS Program)” means that program which is administered by the Department pursuant to Health-General Article, §15-125, Annotated Code of Maryland, to:</text> <paragraph num="(a)"> <text>Provide for specialized medical, surgical, pharmacologic, and related rehabilitative evaluation and treatment services for children with special health care needs younger than 22 years old who:</text> <paragraph num="(i)"> <text>Meet the residential, identification, financial, and medical eligibility requirements; and</text> </paragraph> <paragraph num="(ii)"> <text>Are uninsured or do not have coverage in their existing health insurance plans that cover certain types of medical care;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide and promote family-centered, community-based, coordinated care for children with special health care needs, and promote development of community-based, culturally competent systems of services for those children and their families throughout the State; and</text> </paragraph> <paragraph num="(c)"> <text>Distribute funds to cover specialty diagnostic and treatment services for eligible children with special health care needs in Maryland.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Children with special health care needs” means individuals, birth to 22 years old, who have or who are at increased risk for a chronic physical, development, behavioral, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the CMS Program.</text> </paragraph> <paragraph num="(11)"> <text>“Disabling condition” means a health-related condition or impairment that may hinder achievement of normal growth and development.</text> </paragraph> <paragraph num="(12)"> <text>“Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medical purpose.</text> </paragraph> <paragraph num="(13)"> <text>“Durable medical equipment” means equipment which satisfies all of the following requirements:</text> <paragraph num="(a)"> <text>It can withstand repeated use;</text> </paragraph> <paragraph num="(b)"> <text>It is used to serve a medical purpose; and</text> </paragraph> <paragraph num="(c)"> <text>It is appropriate for use in the home.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services.</text> </paragraph> <paragraph num="(15)"> <text>“Financial eligibility guidelines” means the schedule based upon the federal poverty level which is used to determine financial eligibility for the CMS Program.</text> </paragraph> <paragraph num="(16)"> <text>“General hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed as a general hospital by the Maryland Department of Health, Division of Licensing and Certification, in accordance with COMAR 10.07.01.</text> </paragraph> <paragraph num="(17)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the services are provided.</text> </paragraph> <paragraph num="(19)"> <text>“Income” means any property or service received by a person in cash or in kind which can be applied directly to meet basic needs for food, shelter, and medical expenses.</text> </paragraph> <paragraph num="(20)"> <text>“Long-term hospitalization” means an inpatient stay of more than 2 weeks.</text> </paragraph> <paragraph num="(21)"> <text>“Medical assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(22)"> <text>“Medical care” means medical services and specialized care provided by physicians and allied health professionals in hospitals, convalescent facilities, clinics, private physicians’ offices, in home and other community-based settings. Medical care may include the services rendered by dentists, nurses, medical social workers, childlife specialists, nutritionists, dietitians, psychologists, physical therapists, occupational therapists, speech-language pathologists, audiologists, optometrists, ophthalmologists, technicians, and other pertinent personnel whose services may be needed by those children who are served by the CMS Program.</text> </paragraph> <paragraph num="(23)"> <text>“Medically necessary dental care” means reasonable and appropriate diagnosis, treatment, and follow-up care as determined and prescribed by qualified, appropriate health care providers in treating a condition, disease, injury, birth defect, or development malformation to restore facial configuration or function necessary for speech, swallowing, or chewing.</text> </paragraph> <paragraph num="(24)"> <text>“Physician specialist” means a:</text> <paragraph num="(a)"> <text>Licensed medical doctor who is qualified to practice medicine in a specialty area and who is either board certified or board eligible and who has experience in the care of children; or</text> </paragraph> <paragraph num="(b)"> <text>Resident physician under the supervision of a licensed board-certified physician.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Preauthorization” means an approval required from the Department or its designee before the provision of services.</text> </paragraph> <paragraph num="(26)"> <text>“Provider” means an individual or entity duly licensed or certified to render a health care service or product pursuant to these regulations through an appropriate agreement with the Department, and identified as a CMS Program provider by the issuance of an individual vendor number.</text> </paragraph> <paragraph num="(27)"> <text>“Residency” means living in the State voluntarily with the intention of making the State the individual’s permanent home for an indefinite period and not for a temporary purpose.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Services."> <paragraph num="A."> <text>The CMS Program shall authorize covered services when a CMP has been approved.</text> </paragraph> <paragraph num="B."> <text>The CMP shall:</text> <paragraph num="(1)"> <text>Include:</text> <paragraph num="(a)"> <text>All diagnoses or suspected diagnoses;</text> </paragraph> <paragraph num="(b)"> <text>Service requested or provided;</text> </paragraph> <paragraph num="(c)"> <text>Specific reason for the service request;</text> </paragraph> <paragraph num="(d)"> <text>Evaluation or treatment findings;</text> </paragraph> <paragraph num="(e)"> <text>Follow-up plans related to the service provided by the CMS Program;</text> </paragraph> <paragraph num="(f)"> <text>Source of primary health care; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be reviewed and approved by the CMS Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The CMS Program may request further information from the provider in order to:</text> <paragraph num="(1)"> <text>Support the information required in §B(1) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Assure that all services are coordinated with other services the child is receiving through the CMS Program or other programs; and</text> </paragraph> <paragraph num="(3)"> <text>Assure that the needs of the family are addressed in relation to meeting the medical and developmental needs of the child.</text> </paragraph> </paragraph> <paragraph num="D."> <text>CMS Program eligible services shall include:</text> <paragraph num="(1)"> <text>Specialty clinics;</text> </paragraph> <paragraph num="(2)"> <text>Private office care including, but not limited to, the following:</text> <paragraph num="(a)"> <text>Allergy/Immunology;</text> </paragraph> <paragraph num="(b)"> <text>Audiology and hearing;</text> </paragraph> <paragraph num="(c)"> <text>Cardiology;</text> </paragraph> <paragraph num="(d)"> <text>Craniofacial;</text> </paragraph> <paragraph num="(e)"> <text>Cystic fibrosis;</text> </paragraph> <paragraph num="(f)"> <text>Developmental pediatrics;</text> </paragraph> <paragraph num="(g)"> <text>Endocrine;</text> </paragraph> <paragraph num="(h)"> <text>Gastroenterology;</text> </paragraph> <paragraph num="(i)"> <text>Genetics;</text> </paragraph> <paragraph num="(j)"> <text>Hematology;</text> </paragraph> <paragraph num="(k)"> <text>Infectious disease;</text> </paragraph> <paragraph num="(l)"> <text>Nephrology;</text> </paragraph> <paragraph num="(m)"> <text>Neurology;</text> </paragraph> <paragraph num="(n)"> <text>Neurosurgery;</text> </paragraph> <paragraph num="(o)"> <text>Oncology;</text> </paragraph> <paragraph num="(p)"> <text>Ophthalmology, optometry, and vision;</text> </paragraph> <paragraph num="(q)"> <text>Orthopedics;</text> </paragraph> <paragraph num="(r)"> <text>Otolaryngology;</text> </paragraph> <paragraph num="(s)"> <text>Physical medicine;</text> </paragraph> <paragraph num="(t)"> <text>Plastic surgery;</text> </paragraph> <paragraph num="(u)"> <text>Pulmonology;</text> </paragraph> <paragraph num="(v)"> <text>Rheumatology;</text> </paragraph> <paragraph num="(w)"> <text>Speech-language pathology;</text> </paragraph> <paragraph num="(x)"> <text>Surgery; and</text> </paragraph> <paragraph num="(y)"> <text>Urology.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Primary physician care arranged at the discretion of the CMS Program to assure access for needed specialty diagnostic evaluation, treatment, and care coordination services;</text> </paragraph> <paragraph num="(4)"> <text>Inpatient hospital care services, which are provided by Medical Assistance affiliated hospitals; and</text> </paragraph> <paragraph num="(5)"> <text>Professional evaluation and treatment services, which may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>Audiology;</text> </paragraph> <paragraph num="(b)"> <text>Family training and counseling regarding medical and rehabilitation needs;</text> </paragraph> <paragraph num="(c)"> <text>Genetic counseling;</text> </paragraph> <paragraph num="(d)"> <text>Nursing;</text> </paragraph> <paragraph num="(e)"> <text>Nutrition;</text> </paragraph> <paragraph num="(f)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(g)"> <text>Physical therapy; or</text> </paragraph> <paragraph num="(h)"> <text>Speech-language pathology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Specialized activities to facilitate a special treatment program may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Equipment to provide:</text> <paragraph num="(a)"> <text>Life support;</text> </paragraph> <paragraph num="(b)"> <text>Mobility;</text> </paragraph> <paragraph num="(c)"> <text>Stimulation; and</text> </paragraph> <paragraph num="(d)"> <text>Aid in activities of daily living;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Orthoses to correct or prevent orthopedic disabilities, including prescription shoes and their modifications;</text> </paragraph> <paragraph num="(3)"> <text>Prostheses to replace a missing part or to enhance the applicant's functional performance;</text> </paragraph> <paragraph num="(4)"> <text>Formula and medication to correct metabolic and physiologic errors;</text> </paragraph> <paragraph num="(5)"> <text>Supplies of durable and disposable items to facilitate management of specific disorders;</text> </paragraph> <paragraph num="(6)"> <text>Approved therapies involving specific treatment as authorized by appropriate CMS Program professional staff to cure functional deficiencies;</text> </paragraph> <paragraph num="(7)"> <text>Life sustaining medications;</text> </paragraph> <paragraph num="(8)"> <text>Dental services provided for children with disabling conditions; and</text> </paragraph> <paragraph num="(9)"> <text>Hearing aids and augmentative devices to improve communication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Rights and Responsibilities."> <paragraph num="A."> <text>Applicant.</text> <paragraph num="(1)"> <text>The applicant shall furnish factual information regarding the applicant’s eligibility, and shall keep the CMS Program informed of any change in demographic, financial, medical, or insurance coverage status.</text> </paragraph> <paragraph num="(2)"> <text>An eligible applicant shall use only Medical Assistance approved providers.</text> </paragraph> <paragraph num="(3)"> <text>An applicant shall complete a Medical Assistance application when the applicant is considered potentially eligible.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CMS Program.</text> <paragraph num="(1)"> <text>An applicant who meets eligibility criteria as set forth in this chapter shall have access to approved services within the budgetary limitations of the CMS Program.</text> </paragraph> <paragraph num="(2)"> <text>The CMS Program may purchase health insurance benefits for an eligible child when all of the following conditions are met:</text> <paragraph num="(a)"> <text>The cost of this expense is less than the cost of directly purchasing the child’s medical care;</text> </paragraph> <paragraph num="(b)"> <text>The policyholder is unable to pay for the health insurance policy due to:</text> <paragraph num="(i)"> <text>An increase in insurance cost;</text> </paragraph> <paragraph num="(ii)"> <text>A change in employment;</text> </paragraph> <paragraph num="(iii)"> <text>Loss of income;</text> </paragraph> <paragraph num="(iv)"> <text>An increase in health-related expenses; or</text> </paragraph> <paragraph num="(v)"> <text>The policyholder’s eligibility to purchase health insurance benefits in accordance with the Consolidated Omnibus Budget Reconciliations Act of 1985, P.L. 99-272;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The health insurance policy is issued directly from:</text> <paragraph num="(i)"> <text>An authorized insurer;</text> </paragraph> <paragraph num="(ii)"> <text>A nonprofit health services plan;</text> </paragraph> <paragraph num="(iii)"> <text>A health maintenance organization;</text> </paragraph> <paragraph num="(iv)"> <text>A self-insured health benefit plan; or</text> </paragraph> <paragraph num="(v)"> <text>The employer of the family member whose health insurance provides coverage for the eligible child; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Payment is for premiums that can be costed out as related to the applicant only.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The CMS Program may pay copays, deductibles, and coinsurance costs when the CMS Program is purchasing the health insurance benefits.</text> </paragraph> <paragraph num="(4)"> <text>The CMS Program shall comply with the requirements of:</text> <paragraph num="(a)"> <text>Title VI of the Civil Rights Act of 1964 as amended;</text> </paragraph> <paragraph num="(b)"> <text>The Age Discrimination Act of 1975 as amended;</text> </paragraph> <paragraph num="(c)"> <text>Section 504 of the Rehabilitation Act of 1973 as amended; and</text> </paragraph> <paragraph num="(d)"> <text>The Americans with Disabilities Act of 1989.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The CMS Program shall determine financial assistance based on the income and allowable deductions.</text> </paragraph> <paragraph num="(6)"> <text>The CMS Program shall provide full financial assistance for authorized services when the income is equal to or less than that which is allowable in accordance with the financial eligibility levels described in Regulation .05A(4) of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>The CMS Program shall provide full CMS Program eligible service to the extent that medical assistance for this service is not covered under Title XIX.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="General Eligibility Criteria."> <paragraph num="A."> <text>To be eligible for the CMS Program’s services, an applicant shall:</text> <paragraph num="(1)"> <text>Submit a completed, signed, and dated CMS Program application;</text> </paragraph> <paragraph num="(2)"> <text>Provide documentation of:</text> <paragraph num="(a)"> <text>State residency, as this program is not meant to cover those whose sole purpose in coming to Maryland is to obtain medical care or coverage; and</text> </paragraph> <paragraph num="(b)"> <text>Being younger than 22 years old;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide a form of identification for the applicant and the applicant’s parents or guardians if the applicant is less than 18 years old;</text> </paragraph> <paragraph num="(4)"> <text>Have income that does not exceed:</text> <paragraph num="(a)"> <text>200 percent of the federal poverty level; or</text> </paragraph> <paragraph num="(b)"> <text>250 percent of the federal poverty level, if the applicant is eligible for a medical deduction under Regulation .07D of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have an eligible medical condition as set forth in Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The age eligibility referred to in §A(2)(b) of this regulation may be extended 3 years beyond the 22nd birthday if the CMP:</text> <paragraph num="(1)"> <text>Confirms that current treatment of the condition should be continued in order to prevent a significant disruption in the provision of necessary services; and</text> </paragraph> <paragraph num="(2)"> <text>Documents that the applicant is without third-party insurance or entitlement coverage.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Medical Eligibility."> <paragraph num="A."> <text>Children with special health care needs may be eligible for services covered by the CMS Program.</text> </paragraph> <paragraph num="B."> <text>Chronic medical conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Chronic asthma;</text> </paragraph> <paragraph num="(2)"> <text>Chronic renal disease;</text> </paragraph> <paragraph num="(3)"> <text>Cystic fibrosis;</text> </paragraph> <paragraph num="(4)"> <text>Diabetes and other endocrine disorders;</text> </paragraph> <paragraph num="(5)"> <text>Hemophilia;</text> </paragraph> <paragraph num="(6)"> <text>Immune deficiencies;</text> </paragraph> <paragraph num="(7)"> <text>Juvenile rheumatoid arthritis;</text> </paragraph> <paragraph num="(8)"> <text>Leukemia and other childhood cancers;</text> </paragraph> <paragraph num="(9)"> <text>Phenylketonuria and other inborn errors of metabolism; and</text> </paragraph> <paragraph num="(10)"> <text>Sickle cell anemia and other chronic anemia.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Other medical and surgical conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Biliary atresia;</text> </paragraph> <paragraph num="(2)"> <text>Bronchopulmonary dysplasia;</text> </paragraph> <paragraph num="(3)"> <text>Tracheal esophogeal fistula; and</text> </paragraph> <paragraph num="(4)"> <text>Ulcerative colitis.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Neurodevelopmental conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Brain tumors;</text> </paragraph> <paragraph num="(2)"> <text>Cerebral palsy and other central nervous system disorders;</text> </paragraph> <paragraph num="(3)"> <text>Certain high risk neonates;</text> </paragraph> <paragraph num="(4)"> <text>Closed head injury with residual defects;</text> </paragraph> <paragraph num="(5)"> <text>Down's syndrome and other genetic and chromosomal anomalies;</text> </paragraph> <paragraph num="(6)"> <text>Hydrocephalus;</text> </paragraph> <paragraph num="(7)"> <text>Medical aspects of learning disabilities and attention deficit disorders;</text> </paragraph> <paragraph num="(8)"> <text>Medical aspects of intellectual disability and developmental delay;</text> </paragraph> <paragraph num="(9)"> <text>Muscular atrophies and dystrophies;</text> </paragraph> <paragraph num="(10)"> <text>Spina bifida, myelomeningocele, and the spinal cord dysfunctions;</text> </paragraph> <paragraph num="(11)"> <text>Other neurologic damage;</text> </paragraph> <paragraph num="(12)"> <text>Peripheral neuromuscular disease; and</text> </paragraph> <paragraph num="(13)"> <text>Seizure disorder.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Orthopedic conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Chronic conditions resulting from trauma;</text> </paragraph> <paragraph num="(2)"> <text>Chronic infections of bones and joints;</text> </paragraph> <paragraph num="(3)"> <text>Club foot and other foot deformities;</text> </paragraph> <paragraph num="(4)"> <text>Congenital developmental hip conditions such as congenital hip dislocation;</text> </paragraph> <paragraph num="(5)"> <text>Limb deficiencies and length discrepancies;</text> </paragraph> <paragraph num="(6)"> <text>Skeletal dysplasias and other forms of dwarfism; and</text> </paragraph> <paragraph num="(7)"> <text>Spinal column defects and deformities.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Cardiac conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Arrhythmias;</text> </paragraph> <paragraph num="(2)"> <text>Congenital heart defects;</text> </paragraph> <paragraph num="(3)"> <text>Hypertension; and</text> </paragraph> <paragraph num="(4)"> <text>Rheumatic heart disease.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Craniofacial and dental conditions which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Cleft lip and palate, orofacial defects;</text> </paragraph> <paragraph num="(2)"> <text>Handicapping malocclusions; and</text> </paragraph> <paragraph num="(3)"> <text>Medically necessary dental care related to eligible medical conditions.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Vision, hearing and speech-language conditions, which may render an applicant medically eligible include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Amblyopia;</text> </paragraph> <paragraph num="(2)"> <text>Cataract;</text> </paragraph> <paragraph num="(3)"> <text>Cholesteatoma;</text> </paragraph> <paragraph num="(4)"> <text>Chronic otitis media;</text> </paragraph> <paragraph num="(5)"> <text>Conductive and sensory-neural hearing loss;</text> </paragraph> <paragraph num="(6)"> <text>Otosclerosis;</text> </paragraph> <paragraph num="(7)"> <text>Speech-language disorders;</text> </paragraph> <paragraph num="(8)"> <text>Strabismus; and</text> </paragraph> <paragraph num="(9)"> <text>Velopharyngeal incompetence.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The following are excluded from CMS Program medically eligible services:</text> <paragraph num="(1)"> <text>Well child care;</text> </paragraph> <paragraph num="(2)"> <text>Mental health;</text> </paragraph> <paragraph num="(3)"> <text>Emergency care; and</text> </paragraph> <paragraph num="(4)"> <text>Urgent care.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Care excluded from CMS Program medically eligible conditions unless the services are medically necessary due to the underlying chronic condition includes:</text> <paragraph num="(1)"> <text>Dermatology;</text> </paragraph> <paragraph num="(2)"> <text>Gynecology; and</text> </paragraph> <paragraph num="(3)"> <text>Dental services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Financial Eligibility."> <paragraph num="A."> <text>An applicant's financial eligibility is based upon the composition and income of the family unit.</text> </paragraph> <paragraph num="B."> <text>Family Unit. A family unit consists of one or more of the following members residing in the same household:</text> <paragraph num="(1)"> <text>The applicant;</text> </paragraph> <paragraph num="(2)"> <text>The natural or adoptive parents, stepparents, or legal guardian if the applicant is unmarried;</text> </paragraph> <paragraph num="(3)"> <text>The unmarried natural or adoptive siblings of the applicant who are younger than 22 years old;</text> </paragraph> <paragraph num="(4)"> <text>The lawful spouse of the applicant; or</text> </paragraph> <paragraph num="(5)"> <text>Other individuals who are not included in this regulation and who are dependents for federal income tax purposes.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Income.</text> <paragraph num="(1)"> <text>For the purpose of determining financial eligibility, the CMS Program shall treat the income of members of the family unit listed in §B of this regulation as the sole source for determining an applicant’s eligibility.</text> </paragraph> <paragraph num="(2)"> <text>The CMS Program shall determine the family’s income from the following sources:</text> <paragraph num="(a)"> <text>Wages, including sick or severance pay;</text> </paragraph> <paragraph num="(b)"> <text>Commissions and fees;</text> </paragraph> <paragraph num="(c)"> <text>Salaries and tips;</text> </paragraph> <paragraph num="(d)"> <text>Profit from self-employment, including income from the operation of a farm;</text> </paragraph> <paragraph num="(e)"> <text>The earned income tax credit (EITC);</text> </paragraph> <paragraph num="(f)"> <text>Social Security benefits;</text> </paragraph> <paragraph num="(g)"> <text>Veterans' Administration benefits;</text> </paragraph> <paragraph num="(h)"> <text>Workers' Compensation benefits;</text> </paragraph> <paragraph num="(i)"> <text>Black Lung or Agent Orange benefits;</text> </paragraph> <paragraph num="(j)"> <text>Railroad Retirement;</text> </paragraph> <paragraph num="(k)"> <text>Government, private, or company pensions and annuities;</text> </paragraph> <paragraph num="(l)"> <text>Unemployment insurance benefits;</text> </paragraph> <paragraph num="(m)"> <text>Payments from oil or mineral rights (leases);</text> </paragraph> <paragraph num="(n)"> <text>Government payments on land;</text> </paragraph> <paragraph num="(o)"> <text>Insurance benefits paid directly to an applicant;</text> </paragraph> <paragraph num="(p)"> <text>Trust funds;</text> </paragraph> <paragraph num="(q)"> <text>Individual retirement accounts (IRAs);</text> </paragraph> <paragraph num="(r)"> <text>Keough plans;</text> </paragraph> <paragraph num="(s)"> <text>Military allotments;</text> </paragraph> <paragraph num="(t)"> <text>Alimony or court-ordered and voluntary child support payments received from an absent spouse, or an absent natural or adoptive parent;</text> </paragraph> <paragraph num="(u)"> <text>Loan repayments made to the applicant or family member including, but not limited to, mortgage payments;</text> </paragraph> <paragraph num="(v)"> <text>Lump-sum benefits or other amounts of income received on a one-time-only basis;</text> </paragraph> <paragraph num="(w)"> <text>Profit from rental income;</text> </paragraph> <paragraph num="(x)"> <text>Cash assistance received from non-governmental social service agencies greater than the amount allowed by Medical Assistance;</text> </paragraph> <paragraph num="(y)"> <text>Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act; and</text> </paragraph> <paragraph num="(z)"> <text>Any subsidy covering basic needs for food or shelter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an individual in the family unit has recently resumed employment, the Program shall determine income for a 12-month period by averaging actual income for 6 months preceding resumption of employment and projected income for 6 months following resumption of employment.</text> </paragraph> <paragraph num="(4)"> <text>If additional CMS Program services are requested 6 months after resuming employment, the CMS Program may re-determine financial eligibility based on current income.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Medical Deductions. The applicant may deduct the following from the applicant’s income:</text> <paragraph num="(1)"> <text>Loan payments related to medical or medically related emergency debt;</text> </paragraph> <paragraph num="(2)"> <text>Payment to a hospital or other health care provider for a member of the family unit not covered by other third-party insurance entitlements, or the Program; and</text> </paragraph> <paragraph num="(3)"> <text>Payments for health insurance for a member of the family unit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Effective Dates for Financial Eligibility.</text> <paragraph num="(1)"> <text>The CMS Program shall establish financial eligibility for a 12-month period from the date a completed application is received by the CMS Program.</text> </paragraph> <paragraph num="(2)"> <text>Exceptions to the 12-month financial eligibility period are:</text> <paragraph num="(a)"> <text>If financial eligibility was determined by averaging the previous 6 months, financial eligibility shall be reconsidered after 6 months;</text> </paragraph> <paragraph num="(b)"> <text>When an eligible applicant enrolled in the CMS Program informs the CMS Program of changes in family size, income, or expense, the CMS Program may reconsider eligibility as soon as possible if financial assistance is being given, or when the next request for services is made.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Those receiving CMS Program financial assistance shall notify the CMS Program within 10 business days of any changes in circumstance which could affect continuing financial eligibility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Application Process."> <paragraph num="A."> <text>The CMS Program shall make applications available to, but which are not limited to, the following agencies:</text> <paragraph num="(1)"> <text>Local health department;</text> </paragraph> <paragraph num="(2)"> <text>Admitting, social services, or business office of a participating hospital;</text> </paragraph> <paragraph num="(3)"> <text>Cooperating agencies; and</text> </paragraph> <paragraph num="(4)"> <text>An applicant, upon request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Completion of Application.</text> <paragraph num="(1)"> <text>An applicant, the applicant's parent, guardian, or representative shall submit a complete, signed application approved by the Program.</text> </paragraph> <paragraph num="(2)"> <text>A parent of any age, or an authorized representative of the applicant who is 18 years old or older, shall complete and sign the application for an unmarried applicant younger than 18 years old.</text> </paragraph> <paragraph num="(3)"> <text>A representative of a public or private agency, which may include a foster parent, shall complete and sign the application for a child in custody of the agency.</text> </paragraph> <paragraph num="(4)"> <text>An applicant shall provide financial information for each employed member of the family unit as specified in Regulation .07A of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>An applicant shall provide documents verifying residency, identification, income, and medical conditions or suspected medical conditions.</text> </paragraph> <paragraph num="(6)"> <text>The CMS Program shall make reasonable accommodations to assure that appropriate assistance is provided to those who are disabled or who are unable to speak or write English.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Disposition of Application."> <paragraph num="A."> <text>General.</text> <paragraph num="(1)"> <text>The CMS Program professional staff shall:</text> <paragraph num="(a)"> <text>Review individual applications;</text> </paragraph> <paragraph num="(b)"> <text>Determine CMS Program eligibility and services to be approved for payment by the CMS Program within 30 calendar days of receipt of the complete application;</text> </paragraph> <paragraph num="(c)"> <text>Verify the information provided by an applicant which may include an interview:</text> <paragraph num="(i)"> <text>With the applicant if the applicant is 18 years old or older, or with the applicant’s parent or guardian; and</text> </paragraph> <paragraph num="(ii)"> <text>Which is held at a mutually convenient place and time for all parties.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If additional information is needed to determine eligibility or service needed, the Program shall:</text> <paragraph num="(a)"> <text>Return the application within 15 business days of receipt; and</text> </paragraph> <paragraph num="(b)"> <text>Advise an applicant in writing of needed documentation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 30 calendar days of receipt of the completed application by the CMS Program the CMS Program shall send a written decision regarding Program eligibility to the applicant.</text> </paragraph> <paragraph num="(4)"> <text>For renewal applications, the CMS Program shall notify an applicant in writing at least 30 calendar days before the date on which the applicant shall reapply.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligible Applicant.</text> <paragraph num="(1)"> <text>An eligible applicant shall receive a letter from the CMS Program which includes, at a minimum, the following information:</text> <paragraph num="(a)"> <text>The effective dates of CMS Program eligibility;</text> </paragraph> <paragraph num="(b)"> <text>The name of the provider; and</text> </paragraph> <paragraph num="(c)"> <text>The service to be covered by the CMS Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Ineligible Applicant.</text> <paragraph num="(1)"> <text>An applicant is ineligible when the applicant does not:</text> <paragraph num="(a)"> <text>Provide requested information sufficient to determine eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Complete, sign, and date the application; or</text> </paragraph> <paragraph num="(c)"> <text>Complete an application for Medical Assistance when the applicant is potentially eligible for services covered by Medical Assistance.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant determined ineligible shall receive a letter from the CMS Program informing the applicant of the reasons for the determination.</text> </paragraph> <paragraph num="(3)"> <text>An applicant determined to be ineligible shall be advised of the right to appeal the determination in accordance with the procedures set forth in §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Appeal Rights.</text> <paragraph num="(1)"> <text>Providers filing appeals of administrative decisions made in connection with these regulations shall do so in accordance with Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>An applicant or eligible individual, or other authorized representative has a right to a meeting or informal conference with CMS staff responsible for a decision reflected in any notice of determination issued in this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Record Retention and Confidentiality."> <paragraph num="A."> <text>Records.</text> <paragraph num="(1)"> <text>A provider shall:</text> <paragraph num="(a)"> <text>Retain and reproduce, upon request for a minimum of 6 years, records and reports required by the Department for the administration of services; and</text> </paragraph> <paragraph num="(b)"> <text>Be responsible for maintaining patient records for services that it provides in accordance with the approved Department retention schedule.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Records referred to in §A(1) of this regulation include:</text> <paragraph num="(a)"> <text>Documentation of personal interviews;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosis and treatment recommendations;</text> </paragraph> <paragraph num="(c)"> <text>Records of professional visits and consultations;</text> </paragraph> <paragraph num="(d)"> <text>Consultant notes which shall be appropriately initialed or signed;</text> </paragraph> <paragraph num="(e)"> <text>Medical and laboratory data, including X-rays; and</text> </paragraph> <paragraph num="(f)"> <text>Other data as may be required by applicable federal and State regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Confidentiality. A provider shall assure that the release of information from an eligible applicant's record is handled in accordance with Health-General Article, §§4-301—4-309, Annotated Code of Maryland, COMAR 10.03.02, and other State and federal laws and regulations governing the confidentiality of records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="General Conditions of Provider Participation."> <paragraph num="A."> <text>A provider of services which are covered by the CMS Program shall comply with the following general requirements:</text> <paragraph num="(1)"> <text>For fee for service reimbursement, be approved by Medical Assistance in writing as a Medical Assistance provider;</text> </paragraph> <paragraph num="(2)"> <text>For copay and deductible reimbursement, be a participating provider with the insurance plan purchased by the CMS Program for the family;</text> </paragraph> <paragraph num="(3)"> <text>Request preauthorization on the forms designated by the CMS Program;</text> </paragraph> <paragraph num="(4)"> <text>Adhere to administrative procedures that are established by the CMS Program for the specific treatment services; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain adequate records, including prescriptions, for a minimum of 6 years, and make them available upon request to the Department or the Department's designee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The approval referenced in §A(1) of this regulation shall specify, at a minimum, the following:</text> <paragraph num="(1)"> <text>Approved services which may be provided; and</text> </paragraph> <paragraph num="(2)"> <text>Duration of approval status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Conditions of Hospital Participation."> <text>A hospital shall:</text> <paragraph num="A."> <text>Comply with all relevant State and federal requirements related to the provision of health services and the receipt of funds;</text> </paragraph> <paragraph num="B."> <text>Be licensed by the Department pursuant to the Hospital and Related Institutions subtitle, Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital, and be licensed, as may be required, by other applicable State and local laws;</text> </paragraph> <paragraph num="C."> <text>Be accredited by the Joint Commission for Accreditation of Hospitals; and</text> </paragraph> <paragraph num="D."> <text>Provide the following services:</text> <paragraph num="(1)"> <text>A physician specialist who is qualified in the area of need for which a recipient is hospitalized, and who shall supervise and be involved in:</text> <paragraph num="(a)"> <text>The ongoing care of a child; and</text> </paragraph> <paragraph num="(b)"> <text>Directing the development of the CMP and other appropriate care plans;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pediatric physician supervision on a full-time or part-time basis to assist with:</text> <paragraph num="(a)"> <text>Diagnostic evaluations;</text> </paragraph> <paragraph num="(b)"> <text>Care planning and treatment; and</text> </paragraph> <paragraph num="(c)"> <text>Coordination with others involved in the development of the CMP;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Nursing services provided by a qualified nurse who has academic preparation and work experience in the care of children, including the specialty area of the condition to be treated;</text> </paragraph> <paragraph num="(4)"> <text>Surgical services, which shall have, as a minimum:</text> <paragraph num="(a)"> <text>Anesthesiologists trained and experienced in the management of pediatric patients; and</text> </paragraph> <paragraph num="(b)"> <text>An appropriate recovery area which is staffed by personnel qualified in pediatrics and equipped with appropriate types and sizes of supplies and equipment;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Available consultation in other specialty areas for the cases being treated;</text> </paragraph> <paragraph num="(6)"> <text>Other specialized support services, which shall include, but not be limited to, the following as appropriate:</text> <paragraph num="(a)"> <text>Audiology;</text> </paragraph> <paragraph num="(b)"> <text>Nutrition;</text> </paragraph> <paragraph num="(c)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(d)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(e)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(f)"> <text>Psychology;</text> </paragraph> <paragraph num="(g)"> <text>Social work services; and</text> </paragraph> <paragraph num="(h)"> <text>Speech-language pathology;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>An ongoing inpatient educational program for school-age children, which is approved by the State Department of Education, when long-term hospitalization is required;</text> </paragraph> <paragraph num="(8)"> <text>Discharge planning procedures designed to maximize a child's recovery and rehabilitation, which shall include the following:</text> <paragraph num="(a)"> <text>Predischarge planning activities to include all appropriate staff and representatives of other agencies involved or indicated;</text> </paragraph> <paragraph num="(b)"> <text>Parental counseling regarding a child's medical and social needs after the child's release; and</text> </paragraph> <paragraph num="(c)"> <text>Medical care planning resulting from input of the professionals concerned with a child's treatment;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A discharge summary, which shall include as a minimum, the following:</text> <paragraph num="(a)"> <text>Medications, primary and secondary diagnoses, hospital course, procedures performed, and complications;</text> </paragraph> <paragraph num="(b)"> <text>Special equipment and other home care needs; and</text> </paragraph> <paragraph num="(c)"> <text>Follow-up plans including special transportation needs, if applicable;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A separate area for a child, with provisions made for a parent or guardian to stay 24 hours, and nonrestrictive visiting hours for a parent or guardian;</text> </paragraph> <paragraph num="(11)"> <text>Suitable recreational facilities for children;</text> </paragraph> <paragraph num="(12)"> <text>Facilities to isolate children with communicable diseases or other conditions requiring isolation or separation;</text> </paragraph> <paragraph num="(13)"> <text>Access to appropriate clinical laboratory facilities providing specialized diagnostic and treatment equipment, including radiological and nuclear medicine equipment; and</text> </paragraph> <paragraph num="(14)"> <text>Outpatient facilities to provide follow-up care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="General Billing Procedures."> <paragraph num="A."> <text>A provider shall accept payment at the Medical Assistance rate as payment in full.</text> </paragraph> <paragraph num="B."> <text>A provider shall submit:</text> <paragraph num="(1)"> <text>Requests for payment on the form designated by the CMS Program; and</text> </paragraph> <paragraph num="(2)"> <text>Completed reports and attachments as requested by the CMS Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A provider may not bill the CMS Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Broken or missed appointments;</text> </paragraph> <paragraph num="(3)"> <text>Professional services rendered by mail or telephone; and</text> </paragraph> <paragraph num="(4)"> <text>Services which are provided at no charge to the general public.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The CMS Program shall:</text> <paragraph num="(1)"> <text>Make no direct payment to the family;</text> </paragraph> <paragraph num="(2)"> <text>Pay any claim for services provided on different dates and submitted on a single form, and only if it is received by the CMS Program within 12 months of the earliest date of service; and</text> </paragraph> <paragraph num="(3)"> <text>Pay a claim which is rejected for payment due to improper completion or incomplete information, only if it is properly completed, resubmitted, and received by the CMS Program within the original 12-month period or within 60 calendar days of rejection, whichever is later.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The CMS Program reserves the right to return to the provider, before payment, all:</text> <paragraph num="(1)"> <text>Invoices not properly signed, completed, and accompanied by properly completed forms as required by the Department, to include any necessary preauthorization forms; and</text> </paragraph> <paragraph num="(2)"> <text>Claims not properly completed.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If payment is denied by the CMS Program due to late billing, the provider may not seek payment from the child’s family.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Billing Procedures for Physician Office Services."> <paragraph num="A."> <text>A physician shall:</text> <paragraph num="(1)"> <text>Comply with all procedures listed in Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Charge the CMS Program the usual and customary charge to the general public for similar services; and</text> </paragraph> <paragraph num="(3)"> <text>Bill the CMS Program as specified by the CMS Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The CMS Program shall:</text> <paragraph num="(1)"> <text>Use the fee schedule contained in the Maryland Medical Assistance Program’s Professional Services Provider Manual and Fee Schedule, which is incorporated by reference in COMAR 10.09.02.07D;</text> </paragraph> <paragraph num="(2)"> <text>Pay for covered services that are the lower of the:</text> <paragraph num="(a)"> <text>Physician’s customary charge; or</text> </paragraph> <paragraph num="(b)"> <text>Department's fee schedule;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reimburse the provider for:</text> <paragraph num="(a)"> <text>Dispensed drugs at rates established by COMAR 10.09.03; and</text> </paragraph> <paragraph num="(b)"> <text>Injectable drugs at rates promulgated by the Professional Services Provider Manual and Fee Schedule referenced in §B(1) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The CMS Program reserves the right to negotiate and establish a different fee for the physician or the group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital’s cost.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Billing Procedures for Medically Necessary Dental Services."> <paragraph num="A."> <text>A dentist shall comply with all procedures listed in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The CMS Program shall:</text> <paragraph num="(1)"> <text>Cover approved diagnostic, restorative, and preventive treatment as described in the CMP; and</text> </paragraph> <paragraph num="(2)"> <text>Preauthorize estimates of costs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Billing Procedures for Orthodontic Services."> <paragraph num="A."> <text>An orthodontist shall comply with all procedures listed in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The CMS Program shall:</text> <paragraph num="(1)"> <text>Reimburse for correction of the full permanent dentition; and</text> </paragraph> <paragraph num="(2)"> <text>Give special consideration to services for children with malocclusions in the mixed dentition associated with cleft palates or other craniofacial deformities</text> </paragraph> </paragraph> <paragraph num="C."> <text>The CMS Program may not reimburse for preliminary visits to the orthodontist.</text> </paragraph> <paragraph num="D."> <text>The provider may not charge the patient, parent, or guardian for orthodontic treatment, including retention visits.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Billing Procedures for Durable Goods and Equipment."> <paragraph num="A."> <text>The durable goods and equipment providers shall comply with all procedures listed in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A provider shall charge the CMS Program the usual and customary charge to the general public for similar durable goods and equipment.</text> </paragraph> <paragraph num="C."> <text>The CMS Program shall:</text> <paragraph num="(1)"> <text>Pay for covered services which are the least expensive, except for those described in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Determine, based upon expected duration of medical needs, whether durable medical equipment will be purchased or rented; and</text> </paragraph> <paragraph num="(3)"> <text>Pay for repairs to purchased durable medical equipment and disposable medical supplies according to the Medical Assistance reimbursement rate for charges.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The ownership of equipment shall remain with the CMS Program and shall be recovered at the option of the CMS Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Billing Procedures for Pharmacy Services."> <paragraph num="A."> <text>A pharmacy provider shall comply with all procedures listed in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A pharmacy provider shall:</text> <paragraph num="(1)"> <text>Upon request, produce records to verify any charge to the CMS Program; and</text> </paragraph> <paragraph num="(2)"> <text>Charge the CMS Program the usual and customary charge to the general public for similar prescriptions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Determination of allowable cost for multiple source drugs designated by the Centers for Medicare and Medicaid Services of the Department of Health and Human Services or for each drug listed in the formulary allowable cost shall be the lowest of the maximum allowable cost.</text> </paragraph> <paragraph num="D."> <text>Payment for covered services to a pharmacy shall be made as follows:</text> <paragraph num="(1)"> <text>Payment for formulary drug preparation shall be the:</text> <paragraph num="(a)"> <text>Least expensive available; or</text> </paragraph> <paragraph num="(b)"> <text>Allowable cost according to the State Title XIX Agency;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Payment for over-the-counter drugs is not covered except in extenuating circumstances at the discretion of the CMS Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Billing Procedures for Hospitals."> <paragraph num="A."> <text>All hospitals shall comply with the following procedures:</text> <paragraph num="(1)"> <text>Hospitals located in Maryland that participate in the CMS Program shall charge and be reimbursed at the Medical Assistance rates approved by the Health Services Cost Review Commission;</text> </paragraph> <paragraph num="(2)"> <text>The CMS Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital;</text> </paragraph> <paragraph num="(3)"> <text>The CMS Program may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item;</text> </paragraph> <paragraph num="(4)"> <text>The contractual physicians' salaries shall be included in the room and board rate or the appropriate ancillary service;</text> </paragraph> <paragraph num="(5)"> <text>When a patient is discharged from one general hospital and is admitted to another general hospital and 24 hours have not elapsed between the discharge and admission, the CMS Program shall pay only for those medically necessary days, with the payment for the patient’s hospitalization being apportioned between the two hospitals;</text> </paragraph> <paragraph num="(6)"> <text>The CMS Program shall be contacted regarding exceptions or extenuating circumstances relating to admissions and discharges if the patient returns the same day before the hospital patient count;</text> </paragraph> <paragraph num="(7)"> <text>All nonemergency inpatient hospital admissions require preadmission approval by the CMS Program;</text> </paragraph> <paragraph num="(8)"> <text>Authorization is required by the CMS Program or its designee for more than one preoperative inpatient day; and</text> </paragraph> <paragraph num="(9)"> <text>The CMS Program may not reimburse for hospital admissions where a child has been discharged due to cancellation of planned surgery or treatment. The hospital may not bill the family for these charges.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition, all out-of-state providers shall:</text> <paragraph num="(1)"> <text>Participate in Title XVIII of the Social Security Act;</text> </paragraph> <paragraph num="(2)"> <text>Have in effect a utilization review plan applicable to all patients who receive Medical Assistance under Title XIX of the Social Security Act and which meets the requirements of the Social Security Act, §186(k), unless a waiver has been granted by the Secretary of Health and Human Services; and</text> </paragraph> <paragraph num="(3)"> <text>Meet additional conditions for participation and comply with the requirements specified in Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All hospital services shall be reimbursed at the Medical Assistance rate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a provider, vendor, agent or employee of the provider, vendor, or a person with an ownership interest in the provider or vendor has failed to comply with these regulations, or applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:</text> <paragraph num="(1)"> <text>Suspension from the CMS Program;</text> </paragraph> <paragraph num="(2)"> <text>Withholding of payment from the CMS Program;</text> </paragraph> <paragraph num="(3)"> <text>Removal from the CMS Program; and</text> </paragraph> <paragraph num="(4)"> <text>Disqualification from future participation in the CMS Program, either as a provider or vendor providing services for which CMS Program payment may be claimed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Secretary of the United States Department of Health and Human Services suspends or removes a provider from participation in Medicare or Medical Assistance, the Department shall take similar action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Funding Availability."> <text>Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-125, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 21, 1986 (13:19 Md. R. 2121)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03, .05, and .12 amended as an emergency provision effective January 1, 1987 (14:2 Md. R. 125); adopted permanently effective March 31, 1987 (14:6 Md. R. 715)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective August 24, 1987 (14:17 Md. R. 1871)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed effective November 28, 1988 (15:24 Md. R. 2769)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.18 adopted effective November 28, 1988 (15:24 Md. R. 2769)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.22.08 to COMAR 10.11.03 effective March 1, 1993 (20:4 Md. R. 371)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .08 amended as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D-1 adopted effective March 28, 1994 (21:6 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E—I repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C amended effective April 24, 1995 (22:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20F repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25D amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28A amended effective March 28, 1994 (21:6 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 repealed, new Regulations .30 and .31 adopted, and Regulation .31 recodified to Regulation .32 as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 repealed and new Regulation .30 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30A amended effective March 28, 1994 (21:6 Md. R. 467); April 24, 1995 (22:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 adopted effective March 28, 1994 (21:6 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 repealed and new Regulation .31 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 13, 2015 (42:7 Md. R. 568)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> <chapter num="04" heading="Lead Poisoning Screening Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to set forth requirements for conducting lead poisoning risk assessments, blood tests for lead poisoning of minor children, and the reporting of blood lead analysis in accordance with applicable State law.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administer a blood test for lead poisoning” means to:</text> <paragraph num="(a)"> <text>Draw a blood specimen, by either venous or capillary methodology, and:</text> <paragraph num="(i)"> <text>Send the specimen to a medical laboratory for blood lead analysis; or</text> </paragraph> <paragraph num="(ii)"> <text>Conduct a blood lead analysis at a health care provider's office subject to licensing, certification, and approval by the Laboratories Administration of the Department; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Order a blood specimen to be drawn by a third-party health care provider, by either venous or capillary methodology, and sent to a medical laboratory for blood lead analysis.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“At-risk area” means any geographic area within the State that has been designated by the Department as at-risk for lead exposure in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning.</text> </paragraph> <paragraph num="(3)"> <text>“Blood lead analysis” means the analysis and determination by a medical laboratory of the blood lead level in a blood specimen.</text> </paragraph> <paragraph num="(3-1)"> <text>“Blood lead reference value” means a blood lead level of 3.5 micrograms per deciliter.</text> </paragraph> <paragraph num="(4)"> <text>“CDC” means the federal Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="(5)"> <text>“Child” means an individual younger than 18 years old.</text> </paragraph> <paragraph num="(6)"> <text>Repealed.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>Repealed.</text> </paragraph> <paragraph num="(9)"> <text>“EPSDT” means the Early and Periodic Screening Diagnosis and Treatment program governed by COMAR 10.09.23.</text> </paragraph> <paragraph num="(10)"> <text>“Health care provider” means a person who is licensed, certified, or otherwise authorized to provide health care services under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>Repealed.</text> </paragraph> <paragraph num="(12)"> <text>“Immunization registry” means an immunization registry established and maintained by the Department.</text> </paragraph> <paragraph num="(13)"> <text>“Lead exposure risk questionnaire” means the set of questions used to determine an individual's risk for lead exposure and lead poisoning, as approved by the Department and based on the recommendations from the CDC.</text> </paragraph> <paragraph num="(14)"> <text>Repealed.</text> </paragraph> <paragraph num="(15)"> <text>“Medical laboratory” means a licensed medical laboratory as defined by Health-General Article, §17-201(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Nonprimary care” means health care that:</text> <paragraph num="(a)"> <text>Is given or recommended by a health care provider that is not the individual's primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>Includes but is not limited to episodic health care for acute illness or injury or health care that is given in an emergency room or other urgent care setting.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Prekindergarten Program.</text> <paragraph num="(a)"> <text>“Prekindergarten program” means a public educational or public early intervention program that enrolls or serves children below the level of kindergarten.</text> </paragraph> <paragraph num="(b)"> <text>“Prekindergarten program” includes:</text> <paragraph num="(i)"> <text>Programs that operate within a school and those that operate outside of a school;</text> </paragraph> <paragraph num="(ii)"> <text>Preschool special education programs governed by COMAR 13A.05.01;</text> </paragraph> <paragraph num="(iii)"> <text>Extended Elementary Education Programs governed by COMAR 13A.06.02.01;</text> </paragraph> <paragraph num="(iv)"> <text>Local Infant and Toddler Programs as defined in COMAR 13A.13.01;</text> </paragraph> <paragraph num="(v)"> <text>Head Start and Early Head Start Programs as authorized under the Head Start Act, 42 U.S.C. §9801 et seq.;</text> </paragraph> <paragraph num="(vi)"> <text>Judith P. Hoyer Early Child Care and Education Centers established by Education Article, 5-217, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(vii)"> <text>Any other educational or early intervention program as determined by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Primary care” means health care that:</text> <paragraph num="(a)"> <text>Is continuous, comprehensive and coordinated;</text> </paragraph> <paragraph num="(b)"> <text>Emphasizes prevention of illness and injury; and</text> </paragraph> <paragraph num="(c)"> <text>Includes but is not limited to the following services;</text> <paragraph num="(i)"> <text>Age appropriate screenings;</text> </paragraph> <paragraph num="(ii)"> <text>Diagnosis and treatment of acute and chronic disorders;</text> </paragraph> <paragraph num="(iii)"> <text>Growth and developmental assessments;</text> </paragraph> <paragraph num="(iv)"> <text>Health care supervision;</text> </paragraph> <paragraph num="(v)"> <text>Immunizations;</text> </paragraph> <paragraph num="(vi)"> <text>Patient and parent health and psychosocial counseling;</text> </paragraph> <paragraph num="(vii)"> <text>Physical examinations; and</text> </paragraph> <paragraph num="(viii)"> <text>Referrals to specialty health care providers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Primary care provider” means a health care provider that provides primary care.</text> </paragraph> <paragraph num="(20)"> <text>“Targeting Plan” means the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning developed by the Department that includes but is not limited to:</text> <paragraph num="(a)"> <text>Methodology for determining levels of risk for childhood lead poisoning;</text> </paragraph> <paragraph num="(b)"> <text>Maps of the State designating at-risk areas;</text> </paragraph> <paragraph num="(c)"> <text>Zip code and census tract lists indicating each zip code and census tract's designated level of risk; and</text> </paragraph> <paragraph num="(d)"> <text>Recommendations regarding the prevention of childhood lead poisoning.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“12-month visit” means a well-child evaluation by a health care provider that occurs when a child is between 12 months old and 14 months old.</text> </paragraph> <paragraph num="(22)"> <text>“24-month visit” means a well-child evaluation by a health care provider that occurs when the child is between 24 months old and 26 months old.</text> </paragraph> <paragraph num="(23)"> <text>“Well-child evaluation” means a periodic primary care assessment of a child by a primary care provider in accordance with the:</text> <paragraph num="(a)"> <text>American Academy of Pediatrics' guidelines; or</text> </paragraph> <paragraph num="(b)"> <text>Periodicity schedule established under EPSDT requirements.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Administration of Lead Exposure Risk Questionnaire."> <text>A primary care provider for a child shall complete a lead exposure risk questionnaire:</text> <paragraph num="A."> <text>During the 12-month visit and again during the 24-month visit if the child does not reside in an at-risk area;</text> </paragraph> <paragraph num="B."> <text>If the child does not reside in an at-risk area and is 24 months old or older and younger than 6 years old, and the provider does not have documentation that a blood test for lead poisoning or a lead exposure risk questionnaire has been previously administered to, or completed on behalf of, the child;</text> </paragraph> <paragraph num="C."> <text>At each well-child check for a child who is 6 months old or older and younger than 6 years old, and resides in an at-risk area; and</text> </paragraph> <paragraph num="D."> <text>In accordance with the EPSDT requirements for a child insured under the Maryland Medicaid program regardless of the child's area of residence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Blood Tests for Lead Poisoning."> <paragraph num="A."> <text>A primary care provider for a child who resides, or who is known to have previously resided, in an at-risk area shall administer a blood test for lead poisoning during the 12-month visit and again during the 24-month visit.</text> </paragraph> <paragraph num="B."> <text>A primary care provider for a child who is 24 months old or older and younger than 6 years old who resides, or who is known to have previously resided, in an at-risk area as defined in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning, shall administer a blood test for lead poisoning if the:</text> <paragraph num="(1)"> <text>Child has not previously received a blood test for lead poisoning;</text> </paragraph> <paragraph num="(2)"> <text>Child's parent or guardian fails to provide documentation that the child has previously received a blood test for lead poisoning; or</text> </paragraph> <paragraph num="(3)"> <text>Provider is unable to obtain the results of a previous blood lead analysis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A primary care provider for a child shall administer a blood test for lead poisoning to a child if:</text> <paragraph num="(1)"> <text>An affirmative answer, or a response indicating that the parent or guardian does not know the answer, is given for any question on a lead exposure risk questionnaire that is completed for the child pursuant to Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>The child's parent or guardian requests that the child receive a blood test for lead poisoning regardless of the child's age or area of residence.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a child is insured under Maryland's Medicaid program, the child's primary care provider shall administer a blood test for lead poisoning to the child at the 12-month visit and again at the 24-month visit in accordance with EPSDT requirements regardless of the child's area of residence.</text> </paragraph> <paragraph num="E."> <text>A primary care provider shall administer a blood test for lead poisoning, by venous methodology, if the results of a capillary blood test for lead poisoning indicate a blood lead level that exceeds the blood lead reference level.</text> </paragraph> <paragraph num="F."> <text>For each blood test for lead poisoning administered by a health care provider, the provider shall provide on the lab order form the information for blood lead reporting that is required under Environment Article, §6-303, Annotated Code of Maryland, to the medical laboratory that:</text> <paragraph num="(1)"> <text>Draws the blood specimen; or</text> </paragraph> <paragraph num="(2)"> <text>Performs the blood lead analysis.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Physician offices and other point-of-care laboratories shall comply with the requirements under COMAR 10.10.03.02B(36) and C.</text> </paragraph> <paragraph num="H."> <text>Bona Fide Religious Beliefs — At Risk.</text> <paragraph num="(1)"> <text>If the parent or guardian of a child refuses to consent to a blood test for lead poisoning due to the parent or guardian's stated bona fide religious beliefs and practices, a primary care provider shall:</text> <paragraph num="(a)"> <text>Counsel the parent or guardian that the blood test for lead poisoning is required by law due to the fact that their child is at risk for having a blood lead level that exceeds the blood lead reference level; and</text> </paragraph> <paragraph num="(b)"> <text>Complete a lead exposure risk questionnaire for the child in the presence of the child and the child's parent or guardian.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an affirmative response to the questionnaire under §H(1)(b) of this regulation, or a response indicating that the parent or guardian does not know the answer, is entered for any question on the lead exposure risk questionnaire for the child, the provider shall:</text> <paragraph num="(a)"> <text>Further counsel the parent or guardian regarding the risks of lead poisoning, including the potential physical, behavioral, developmental, and intellectual effects, and again request the parent or guardian to consent to a blood test for lead poisoning;</text> </paragraph> <paragraph num="(b)"> <text>Document in the child's medical record any continued refusal by the parent or guardian to consent to a blood test for lead poisoning despite counseling, and the grounds for the parent or guardian's refusal;</text> </paragraph> <paragraph num="(c)"> <text>Write and sign an order for a blood test for lead poisoning on a medical laboratory order form; and</text> </paragraph> <paragraph num="(d)"> <text>Give the child's parent or guardian the completed order for the medical laboratory to draw a blood specimen for blood lead analysis.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If all the responses to the lead exposure risk questionnaire are negative, the provider shall:</text> <paragraph num="(a)"> <text>Follow procedures set forth in §H(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Complete a form issued by the Department indicating that the questionnaire was completed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Repealed.</text> </paragraph> <paragraph num="J."> <text>This regulation does not limit the duties of the child's health care provider, with respect to any child who resides or has previously resided in an at-risk area, under any other provision of the law.</text> </paragraph> <paragraph num="K."> <text>A health care provider giving nonprimary care to a child may, but is not required to, administer a blood test for lead poisoning, even if a blood test for lead poisoning is not medically indicated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Documentation Requirements on Entry into a Prekindergarten Program, Kindergarten Program, or First Grade."> <paragraph num="A."> <text>The parent or guardian of a child who currently resides, or has previously resided, in an at-risk area shall provide to the administrator of the child’s school or program, or the administrator’s designee, certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, on first entry into a:</text> <paragraph num="(1)"> <text>Maryland public prekindergarten program; or</text> </paragraph> <paragraph num="(2)"> <text>Maryland public school system at the level of prekindergarten, kindergarten or first grade.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An electronic report of the child’s blood lead analysis from a health care provider to the administrator of the child’s school or program, or the administrator’s designee, may serve as an acceptable alternative to the documentation required in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>A health care provider shall:</text> <paragraph num="(1)"> <text>Document and certify by signature the dates of the blood lead analysis administered to a child pursuant to Regulation .04A of this chapter on a form developed by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Upon request by the child’s public school or program administrator, or the administrator’s designee, for a child who resides or has previously resided in an at-risk area, provide to the school or program the certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, in order to facilitate the Department’s public health surveillance activities relating to lead poisoning.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The child’s parent or guardian shall provide certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, administered in connection with the 12-month visit and 24-month visit to a Maryland public prekindergarten program not later than:</text> <paragraph num="(1)"> <text>20 calendar days from the 12-month visit or 24-month visit; or</text> </paragraph> <paragraph num="(2)"> <text>20 calendar days from first entry into the program or system.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Pursuant to Regulation .04A of this chapter, if the child’s first blood test for lead poisoning was administered after the child is 24 months old, then only certified documentation of the most recent blood lead analysis is required to be reported pursuant to §C of this regulation.</text> </paragraph> <paragraph num="F."> <text>Pursuant to Regulation .04A of this chapter, if a child has more than two blood tests for lead poisoning done between the ages of 12 months and 24 months, then only certified documentation of the two most recent blood lead analyses shall be reported.</text> </paragraph> <paragraph num="G."> <text>The information sent to or received by a program or school pursuant to §A of this regulation shall be recorded and certified by a health care provider’s signature on a form issued by the Department that includes the following:</text> <paragraph num="(1)"> <text>Name of the child;</text> </paragraph> <paragraph num="(2)"> <text>Date and result of the blood lead analysis; and</text> </paragraph> <paragraph num="(3)"> <text>The signature of the:</text> <paragraph num="(a)"> <text>Child's primary care provider or designee; or</text> </paragraph> <paragraph num="(b)"> <text>School health professional or designee that transcribed the information onto the form issued by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>If a child is not required to receive a blood test for lead poisoning pursuant to Regulation .04A or B of this chapter, then the child's parent or guardian shall provide to the administrator of the child's school or program, or the administrator's designee, on a form issued by the Department, documentation that the child does not reside and has never resided in an at-risk area.</text> </paragraph> <paragraph num="I."> <text>If a parent or guardian does not consent to a blood test for lead poisoning pursuant to Regulation .04H of this chapter, the child’s parent or guardian shall:</text> <paragraph num="(1)"> <text>Take their child to a primary care provider for the provider to complete a lead poisoning risk assessment questionnaire; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the administrator of the child's school or program, or the administrator's designee, a written, signed statement of exemption on a form issued by the Department.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Notice Required.</text> <paragraph num="(1)"> <text>The program or school shall give notice in accordance with §J(2) of this regulation to the parent or guardian of a child who resides or has resided in an at-risk area who does not provide:</text> <paragraph num="(a)"> <text>The certified documentation of the child’s blood lead analysis, as specified in §G of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>A signed statement of exemption.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice required under this section shall state that the parent or guardian is required by law to provide the information under §J(1) of this regulation at the time of enrollment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Blood Lead Analysis Reporting Requirements."> <paragraph num="A."> <text>Notwithstanding §B of this regulation, a medical laboratory shall report, to the Department of the Environment, the information required under Environment Article, §6-303, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A medical laboratory that performs blood lead analysis shall report the results of all blood tests for lead poisoning, performed pursuant to Regulation .04 of this chapter for a child who resides in Baltimore City, to the Commissioner of the Baltimore City Health Department in accordance with Article-Health, §4-607, Baltimore City Revised Code.</text> </paragraph> <paragraph num="C."> <text>The Commissioner of the Baltimore City Health Department may report the information received under §B of this regulation to the Baltimore Immunization Registry Program.</text> </paragraph> <paragraph num="D."> <text>The Department may report the results of blood lead analysis to an immunization registry developed by the Department.</text> </paragraph> <paragraph num="E."> <text>The Department of the Environment may report the results of blood lead analysis to an immunization registry developed by the Department.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §7-403; Environment Article, §6-303; and Health-General Article, §18-106; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 12, 2003 (30:9 Md. R. 614)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486); March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> </annotations> </chapter> <chapter num="05" heading="Child Death Review Case Reporting System"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to clarify the authority of State and local child fatality review teams in Maryland to participate in certain national child death review case reporting systems as a means to enhance the CFR teams' ability to more effectively carry out its purpose of:</text> <paragraph num="A."> <text>Developing an understanding of the causes and incidence of child deaths;</text> </paragraph> <paragraph num="B."> <text>Developing plans for and implementing changes within the agencies represented on the child fatality review teams to prevent child deaths; and</text> </paragraph> <paragraph num="C."> <text>Advising the Governor, the General Assembly, and the public on changes to law, policy, and practice to prevent child deaths.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter controls the drafting and implementation of data use agreements between the State child fatality review team and other public or private organizations or entities in order to assure that Maryland's State and local child fatality review teams are able to participate in and utilize recognized, appropriate national child death review case reporting systems in a secure manner that comports with applicable laws governing the confidentiality of child death information.</text> </paragraph> <paragraph num="B."> <text>This chapter governs the:</text> <paragraph num="(1)"> <text>Maintenance of confidential child death review case data;</text> </paragraph> <paragraph num="(2)"> <text>Participation of State and local child fatality review teams in national child death review reporting systems; and</text> </paragraph> <paragraph num="(3)"> <text>Aggregation and reporting of de-identified child death data in the administration of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Child death review (CDR) case reporting system” means a national standardized, web-based reporting system for the confidential collection, analysis, aggregation, and reporting of child death data that is maintained and operated by a national center for child death review (NCCDR).</text> </paragraph> <paragraph num="(2)"> <text>“Data use agreement” means a contract between the Department and a NCCDR that establishes the terms and conditions for the State and local CFR teams' participation in a child death review case reporting system.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Local child fatality review (CFR) team” means a multidisciplinary and multiagency review team established by a county under Health-General Article, §5-705, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“National center for child death review (NCCDR)” means a public, private, nonprofit, or governmental organization or entity that is:</text> <paragraph num="(a)"> <text>Funded or otherwise recognized by the United States Department of Health and Human Services (DHHS); and</text> </paragraph> <paragraph num="(b)"> <text>Responsible for:</text> <paragraph num="(i)"> <text>Developing a CDR case reporting system;</text> </paragraph> <paragraph num="(ii)"> <text>Training and serving as a liaison to State agencies participating in the system; and</text> </paragraph> <paragraph num="(iii)"> <text>Disseminating national child death review data generated by the system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“State Child Fatality Review (CFR) Team” means the State-level multidisciplinary and multiagency review team established under Health-General Article, §5-702, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Data Use Agreement."> <paragraph num="A."> <text>The Department may enter into a data use agreement with a NCCDR to participate in the NCCDR's case reporting system.</text> </paragraph> <paragraph num="B."> <text>The purpose of the data use agreement is to establish the terms and conditions for:</text> <paragraph num="(1)"> <text>The confidential submission, collection, storage, and analysis of data obtained from the child death case reviews submitted by Maryland's State and local CFR teams; and</text> </paragraph> <paragraph num="(2)"> <text>The reporting, aggregation, and dissemination of de-identified child death review data generated by the CDR case reporting system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="National Center for Child Death Review's Duties."> <text>The data use agreement with the NCCDR shall:</text> <paragraph num="A."> <text>Assure that the State and local CFR teams have full access to and use of the CDR reporting system for the purposes of collecting, analyzing, aggregating, and reporting on child death review data;</text> </paragraph> <paragraph num="B."> <text>Facilitate the comparison of aggregate, de-identified child death data within and among the State and local CFR teams; and</text> </paragraph> <paragraph num="C."> <text>Require that the NCCDR acts as a fiduciary agent of the State and local CFR teams in carrying out their responsibilities under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Electronic Data Transmittal."> <text>Staff of the State or local CFR team shall first de-identify or remove information which would allow identification of an individual from any CFR team reports filed with, or information electronically transmitted by staff to, the NCCDR.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality of Data."> <text>If any personally identifying child fatality review information or record is acquired by the NCCDR or its staff, that information or record is confidential and subject to the same confidentiality and discovery protections set forth in Health-General Article, §5-709, Annotated Code of Maryland, that apply to the State and local CFR teams.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Terms and Construction of a Data Use Agreement."> <text>Any data use agreement entered into by the State CFR Team and a NCCDR shall:</text> <paragraph num="A."> <text>Incorporate by reference and be construed in accordance with the provisions of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland, and this chapter; and</text> </paragraph> <paragraph num="B."> <text>Be coexecuted by:</text> <paragraph num="(1)"> <text>The Secretary or the Secretary's designee; and</text> </paragraph> <paragraph num="(2)"> <text>The chairperson of the State CFR Team.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and 5-704, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 6, 2009 (36:7 Md R. 524)</annotation> </annotations> </chapter> <chapter num="06" heading="Morbidity, Mortality, and Quality Review Committee — Pregnancy and Childhood"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not apply to the review of a fetal death that is the result of a voluntary or therapeutic termination of pregnancy.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Committee” means the Morbidity, Mortality, and Quality Review Committee established within the Department.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Jurisdiction” means a political subdivision of the State, including the 23 counties and Baltimore City.</text> </paragraph> <paragraph num="(4)"> <text>“Early childhood” means the period in which an individual is younger than 6 years old.</text> </paragraph> <paragraph num="(5)"> <text>“Fetal and infant mortality review (FIMR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team established by a health officer or health officers of a group of jurisdictions.</text> </paragraph> <paragraph num="(6)"> <text>“Fetal death” has the meaning stated in Health-General Article, §4-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Health officer” has the meaning stated in Health-General Article, §1-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Infant death” means death occurring to an individual who is younger than 1 year old.</text> </paragraph> <paragraph num="(10)"> <text>“Maryland Perinatal System Standards” means the hospital perinatal program standards established by the Perinatal Clinical Advisory Committee of the Department.</text> </paragraph> <paragraph num="(11)"> <text>“Morbidity, mortality, and quality review (MMQR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team, or entity established to review cases associated with pregnancy, childbirth, infancy, or early childhood in order to make improvements in systems of care, including:</text> <paragraph num="(a)"> <text>A fetal and infant mortality review team; or</text> </paragraph> <paragraph num="(b)"> <text>Another multidisciplinary and multiagency review team or other entity established for a jurisdiction that addresses an aspect of morbidity, mortality, or quality of care associated with pregnancy, childbirth, infancy, or early childhood.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Perinatal center” means a hospital that offers obstetric or neonatal services, or both.</text> </paragraph> <paragraph num="(13)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(14)"> <text>“Transport” means the transfer of a patient to another health care facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>The Maryland Perinatal System Standards (Perinatal Clinical Advisory Committee, June 2014) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Morbidity, Mortality, and Quality Review Committee."> <text>There is a Morbidity, Mortality, and Quality Review Committee established within the Department.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Membership."> <paragraph num="A."> <text>The Committee shall be:</text> <paragraph num="(1)"> <text>A State-level multidisciplinary and multiagency review Committee within the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Composed of at least 26 members as described in §§B and C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Ex Officio Members. The Committee shall include the following ex officio members or their designees:</text> <paragraph num="(1)"> <text>The Secretary of the Maryland Department of Health;</text> </paragraph> <paragraph num="(2)"> <text>The Secretary of Human Services;</text> </paragraph> <paragraph num="(3)"> <text>The Deputy Secretary of the Health Care Financing Administration;</text> </paragraph> <paragraph num="(4)"> <text>The Director of the Vital Statistics Administration;</text> </paragraph> <paragraph num="(5)"> <text>The Director of the Prevention and Health Promotion Administration;</text> </paragraph> <paragraph num="(6)"> <text>The Director of the Behavioral Health Administration;</text> </paragraph> <paragraph num="(7)"> <text>The Director of the Maternal and Child Health Bureau;</text> </paragraph> <paragraph num="(8)"> <text>The Chief Medical Examiner;</text> </paragraph> <paragraph num="(9)"> <text>The Director of the Office of Minority Health and Health Disparities;</text> </paragraph> <paragraph num="(10)"> <text>The Director of the Office of Health Care Quality;</text> </paragraph> <paragraph num="(11)"> <text>The Executive Director of the Maryland Health Care Commission;</text> </paragraph> <paragraph num="(12)"> <text>The Executive Director of the Maryland Institute for Emergency Medical Services Systems;</text> </paragraph> <paragraph num="(13)"> <text>The Executive Director of the Medical and Chirurgical Faculty of Maryland;</text> </paragraph> <paragraph num="(14)"> <text>The President of the Maryland Hospital Association;</text> </paragraph> <paragraph num="(15)"> <text>The President of the Maryland Chapter of the American Academy of Pediatrics;</text> </paragraph> <paragraph num="(16)"> <text>The Chair of the Maryland Section of the American College of Obstetricians and Gynecologists;</text> </paragraph> <paragraph num="(17)"> <text>One representative from the University of Maryland School of Medicine;</text> </paragraph> <paragraph num="(18)"> <text>One representative from the Johns Hopkins School of Medicine;</text> </paragraph> <paragraph num="(19)"> <text>Three representatives from the Maryland Association of County Health Officers;</text> </paragraph> <paragraph num="(20)"> <text>The Chair of the Maryland State Child Fatality Review Team; and</text> </paragraph> <paragraph num="(21)"> <text>The Chair of the Maryland Maternal Mortality Review Committee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Appointed Members.</text> <paragraph num="(1)"> <text>The Secretary shall appoint one Committee member that is a certified nurse midwife from a list of qualified individuals submitted by professional nursing organizations that represent licensed registered nurses in Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary may appoint up to five other Committee members and may appoint additional members who are individuals with an interest and expertise in pregnancy, childbirth, infancy, or early childhood or other related disciplines as considered necessary by the Secretary to carry out the Committee’s responsibilities.</text> </paragraph> <paragraph num="(3)"> <text>Appointed Committee members shall serve at the pleasure of the Secretary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Designation of Representatives. An ex officio member described under §B of this regulation may designate another individual to represent the member on the Committee from the member’s:</text> <paragraph num="(1)"> <text>Agency;</text> </paragraph> <paragraph num="(2)"> <text>Department;</text> </paragraph> <paragraph num="(3)"> <text>Office; or</text> </paragraph> <paragraph num="(4)"> <text>Organization.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Invitees. The Secretary may invite representatives from other agencies and organizations, and individuals involved in the prevention or reduction of morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood, to attend a Committee meeting if the representative has information that may be necessary to inform the Committee.</text> </paragraph> <paragraph num="F."> <text>Term of Appointment. Appointed members shall serve for a term of 3 years.</text> </paragraph> <paragraph num="G."> <text>Staffing. The Committee may employ staff in accordance with the State budget.</text> </paragraph> <paragraph num="H."> <text>Expenses. Members of the Committee shall serve without compensation, but may be reimbursed for reasonable expenses incurred in the performance of their duties:</text> <paragraph num="(1)"> <text>In accordance with the standard State travel regulations; and</text> </paragraph> <paragraph num="(2)"> <text>As provided in the State budget.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Chairperson. The Secretary or the Secretary's designee shall serve as Chairperson of the Committee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Committee Duties."> <paragraph num="A."> <text>To achieve its purpose, the Committee shall:</text> <paragraph num="(1)"> <text>Provide consultation to FIMR teams and other MMQR teams;</text> </paragraph> <paragraph num="(2)"> <text>Conduct confidential and anonymous case reviews of morbidity and mortality associated with pregnancy, childbirth, infancy, and early childhood;</text> </paragraph> <paragraph num="(3)"> <text>Undertake annual statistical analysis of the incidence and cause of morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;</text> </paragraph> <paragraph num="(4)"> <text>Monitor hospital compliance with the Maryland Perinatal System Standards by:</text> <paragraph num="(a)"> <text>Reviewing documents requested of the hospital in writing or by conducting on-site reviews, or by both; and</text> </paragraph> <paragraph num="(b)"> <text>Making recommendations to improve or facilitate compliance; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Determine factors contributing to morbidity and mortality, and make recommendations for strategies to prevent and reduce morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood throughout the State, including recommendations for changes to law, policy, or practice to prevent and reduce morbidity and mortality and improve the system of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Committee may:</text> <paragraph num="(1)"> <text>Evaluate the continued effectiveness and efficiency of the Statewide morbidity, mortality, and quality review process associated with pregnancy, childbirth, infancy, and early childhood and make or recommend appropriate changes as necessary;</text> </paragraph> <paragraph num="(2)"> <text>Establish special panels or ad hoc subcommittees of the Committee as necessary to carry out the duties of the Committee;</text> </paragraph> <paragraph num="(3)"> <text>Analyze data and review reports or other information from:</text> <paragraph num="(a)"> <text>FIMR teams;</text> </paragraph> <paragraph num="(b)"> <text>Other MMQR teams; or</text> </paragraph> <paragraph num="(c)"> <text>Other entities which are established for the purpose of addressing an aspect of morbidity, mortality, or quality reviews associated with pregnancy, childbirth, infancy, or early childhood;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;</text> </paragraph> <paragraph num="(5)"> <text>Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care;</text> </paragraph> <paragraph num="(6)"> <text>Review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties; and</text> </paragraph> <paragraph num="(7)"> <text>Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Local Teams — Establishment and Purpose."> <paragraph num="A."> <text>A jurisdiction shall have a multidisciplinary and multiagency FIMR team or other MMQR team.</text> </paragraph> <paragraph num="B."> <text>The purpose of a FIMR team is to facilitate the reduction of fetal and infant deaths by:</text> <paragraph num="(1)"> <text>Conducting confidential case reviews of fetal and infant deaths including the examination of available medical and healthcare information involving fetal and infant mortality; and</text> </paragraph> <paragraph num="(2)"> <text>Based on the findings of the case reviews conducted under §B(1) of this regulation:</text> <paragraph num="(a)"> <text>Determining factors contributing to fetal and infant deaths;</text> </paragraph> <paragraph num="(b)"> <text>Developing recommendations to reduce factors contributing to fetal and infant deaths;</text> </paragraph> <paragraph num="(c)"> <text>Recommending strategies to improve the system of care in an effort to prevent or reduce fetal and infant deaths; and</text> </paragraph> <paragraph num="(d)"> <text>Informing the Committee of changes that affect fetal and infant deaths in:</text> <paragraph num="(i)"> <text>Local law;</text> </paragraph> <paragraph num="(ii)"> <text>Policy; or</text> </paragraph> <paragraph num="(iii)"> <text>Practices.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A FIMR team shall:</text> <paragraph num="(1)"> <text>Analyze fetal and infant deaths to determine contributing system factors; and</text> </paragraph> <paragraph num="(2)"> <text>Make recommendations for systems change as appropriate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A FIMR team may:</text> <paragraph num="(1)"> <text>Evaluate the continued effectiveness and efficiency of the local fetal and infant mortality review process and make appropriate changes; and</text> </paragraph> <paragraph num="(2)"> <text>Establish protocols in compliance with State statutes and regulations, as applicable, for:</text> <paragraph num="(a)"> <text>Data collection;</text> </paragraph> <paragraph num="(b)"> <text>Analysis; and</text> </paragraph> <paragraph num="(c)"> <text>Reporting.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="FIMR Teams — Membership."> <paragraph num="A."> <text>Members of a FIMR team shall be appointed by the local health officer of the jurisdiction or be jointly appointed by the health officers of the jurisdictions comprising the multi-jurisdiction local team.</text> </paragraph> <paragraph num="B."> <text>A FIMR team shall appoint a chairman from among its membership.</text> </paragraph> <paragraph num="C."> <text>A FIMR team shall be multidisciplinary and include professionals and representatives of agencies that provide services or community resources for families in the community and community representatives.</text> </paragraph> <paragraph num="D."> <text>A FIMR team shall include at least one representative from:</text> <paragraph num="(1)"> <text>Public health programs, such as:</text> <paragraph num="(a)"> <text>Maternal and child health;</text> </paragraph> <paragraph num="(b)"> <text>Substance abuse; or</text> </paragraph> <paragraph num="(c)"> <text>Mental health;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Health care provider specialties, such as:</text> <paragraph num="(a)"> <text>Obstetrics;</text> </paragraph> <paragraph num="(b)"> <text>Pediatrics;</text> </paragraph> <paragraph num="(c)"> <text>Social work;</text> </paragraph> <paragraph num="(d)"> <text>Nursing; or</text> </paragraph> <paragraph num="(e)"> <text>Nurse midwifery; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Hospitals, such as hospital administrators, or professionals with expertise in perinatal services or quality improvement.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A FIMR team may include representatives from other agencies or community organizations involved with the prevention or reduction of fetal and infant deaths.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="MMQR Teams — General."> <text>MMQR teams may:</text> <paragraph num="A."> <text>Inform the Committee of changes that affect morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood in:</text> <paragraph num="(1)"> <text>Local law;</text> </paragraph> <paragraph num="(2)"> <text>Policy; or</text> </paragraph> <paragraph num="(3)"> <text>Practice; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide the Committee with requested reports and other information so that the Committee may perform its duties.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Types of Committee Reviews."> <text>The Committee may conduct morbidity, mortality, and quality reviews associated with pregnancy, childbirth, infancy, and early childhood, including but not limited to reviews of the following:</text> <paragraph num="A."> <text>Individual cases or clusters of cases of morbidity or mortality;</text> </paragraph> <paragraph num="B."> <text>Maternal or neonatal transport to or from perinatal centers; and</text> </paragraph> <paragraph num="C."> <text>Aggregate or hospital-specific cases of mortality or morbidity associated with pregnancy, childbirth, infancy, or early childhood.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Access to Records and Information."> <paragraph num="A."> <text>A health care provider, hospital, HIPAA (Health Insurance Portability and Accountability Act of 1996) business associate, or other related entity shall, on written request of the Committee, FIMR team, other MMQR team, or their staff, provide access to records concerning:</text> <paragraph num="(1)"> <text>Prepregnancy, prenatal, and postpartum care of the mother;</text> </paragraph> <paragraph num="(2)"> <text>Somatic, dental, and behavioral health of the mother;</text> </paragraph> <paragraph num="(3)"> <text>The health care provided by:</text> <paragraph num="(a)"> <text>A health care provider;</text> </paragraph> <paragraph num="(b)"> <text>A health care facility; or</text> </paragraph> <paragraph num="(c)"> <text>Emergency medical services;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Emergency medical services system data on maternal and neonatal transport;</text> </paragraph> <paragraph num="(5)"> <text>State vital records data related to morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood; and</text> </paragraph> <paragraph num="(6)"> <text>Documentation relevant to the purpose and duties of the Committee, FIMR team, or other MMQR team that is maintained by a State or local government agency, including:</text> <paragraph num="(a)"> <text>Medical examiner investigative information; and</text> </paragraph> <paragraph num="(b)"> <text>Law enforcement investigative information, including police reports.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Committee, FIMR team, or other MMQR team shall assign staff to abstract information from patient medical records and other sources of information to which the Committee, FIMR teams, or other MMQR teams are entitled under §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>Information abstracted under §B of this regulation shall be de-identified by the abstractor to remove information that would permit the identification of an individual health care recipient before the information may be used to carry out the purpose and duties of the Committee, FIMR team, or other MMQR team.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Meetings."> <paragraph num="A."> <text>The Committee shall meet at least semiannually.</text> </paragraph> <paragraph num="B."> <text>FIMR teams shall meet at least quarterly.</text> </paragraph> <paragraph num="C."> <text>A meeting of the Committee, FIMR teams, or other MMQR teams shall be closed to the public and is not subject to General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland, when the Committee, local FIMR team, or other MMQR team is reviewing cases of pregnancy, childbirth, infancy, or early childhood.</text> </paragraph> <paragraph num="D."> <text>The Committee, FIMR team, or other MMQR team may invite an individual who is not a member to attend a Committee, FIMR team, or other MMQR team meeting if:</text> <paragraph num="(1)"> <text>The attendance is approved in advance by the Committee, FIMR team, or other MMQR team chairperson;</text> </paragraph> <paragraph num="(2)"> <text>Participation of the invited individual is intended to assist the Committee, FIMR team, or other MMQR team in carrying out its duties; and</text> </paragraph> <paragraph num="(3)"> <text>Invitees in attendance abide by the same confidentiality and nondisclosure requirements which govern the Committee, FIMR team, and other MMQR team members.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Confidentiality of Records and Information."> <paragraph num="A."> <text>The following shall be held confidential and may not be released to a person except as provided in this chapter:</text> <paragraph num="(1)"> <text>Records and information received by the Committee, FIMR team, or other MMQR team;</text> </paragraph> <paragraph num="(2)"> <text>Documents produced in the case review process; and</text> </paragraph> <paragraph num="(3)"> <text>Minutes of meetings of the Committee, FIMR team, or other MMQR team.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Information and records obtained by the Committee, a FIMR team, or other MMQR team are exempt from disclosure under General Provisions Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Committee, a FIMR team, or other MMQR team may not discuss, disclose, or use information for purposes other than as necessary to carry out the Committee’s, FIMR team’s, or other MMQR team’s duties and purposes under this chapter.</text> </paragraph> <paragraph num="D."> <text>Information that is disclosed to the public by the Committee, FIMR team, or other MMQR team shall be de-identified and may not contain information that would permit the identification of an individual, a health care provider, or a health care facility.</text> </paragraph> <paragraph num="E."> <text>The Committee, a FIMR team, or other MMQR team may release specific findings that relate to aggregate data as well as recommendations made by the Committee, FIMR team, or other MMQR team to prevent and reduce morbidity and mortality, and this information shall be public record.</text> </paragraph> <paragraph num="F."> <text>The Committee, FIMR team, other MMQR team, or their staff shall maintain the confidentiality of information used or addressed at meetings.</text> </paragraph> <paragraph num="G."> <text>A person in attendance at a meeting of the Committee, a FIMR team, or other MMQR team may not testify or be required to testify as to what transpired at that part of the meeting that is closed under General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="H."> <text>A member of the Committee, FIMR team, other MMQR team, their staff, or invitees may not be questioned in a civil or criminal proceeding regarding information presented at or opinions formed as a result of a closed Committee, FIMR team, or other MMQR team meeting.</text> </paragraph> <paragraph num="I."> <text>A member of the Committee, FIMR team, other MMQR team, their staff, or invitees, may testify in a civil or criminal proceeding to information that is:</text> <paragraph num="(1)"> <text>Obtained independent of the Committee, FIMR team, or other MMQR team; and</text> </paragraph> <paragraph num="(2)"> <text>Publicly available, except as otherwise provided by law.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Information, documents, and records of the Committee, a FIMR team, or other MMQR team are not subject, in a civil or criminal proceeding, to:</text> <paragraph num="(1)"> <text>Subpoena;</text> </paragraph> <paragraph num="(2)"> <text>Discovery; or</text> </paragraph> <paragraph num="(3)"> <text>Introduction as evidence.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Information, documents, and records obtained by the Committee, a FIMR team, or other MMQR team that are available from other sources may be subject, as provided by applicable law, to:</text> <paragraph num="(1)"> <text>Subpoena;</text> </paragraph> <paragraph num="(2)"> <text>Discovery; or</text> </paragraph> <paragraph num="(3)"> <text>Introduction into evidence.</text> </paragraph> </paragraph> <paragraph num="L."> <text>A person may not be held liable for civil damages or subject to a criminal or disciplinary action for good faith efforts made to comply with the provisions of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-107, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 21, 2009 (36:19 Md R. 1436)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 23, 2018 (45:8 Md. R. 421)</annotation> </annotations> </chapter> <chapter num="07" heading="Prohibition of Sale of Baby Bumper Pads"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ASTM Standards” means the standard consumer safety performance specifications for infant bedding and related accessories set by the American Society for Testing and Materials (ASTM).</text> </paragraph> <paragraph num="(2)"> <text>“Baby bumper pads” means a pad or pads of non-mesh material resting directly above the mattress in a crib, running the circumference of the crib or along the length of any of the interior sides of the crib, and intended to be used until the age that an infant pulls to stand.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Hazardous material” has the meaning stated in Health-General Article, §22-501, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="General Provisions."> <paragraph num="A."> <text>Baby bumper pads are hereby declared to be a hazardous material and may not be shipped or sold to a purchaser in Maryland beginning June 21, 2013.</text> </paragraph> <paragraph num="B."> <text>ASTM Standards.</text> <paragraph num="(1)"> <text>After notification that ASTM has adopted a new voluntary standard for baby bumper pads, the Secretary may provide an opportunity for public comment on whether the new ASTM Standards should replace the prohibition contained in §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Within 60 days after the close of public comment, the Secretary may issue an order permitting the sale of baby bumper pads that comply with the new ASTM Standards if the Secretary determines that such bumper pads are not a danger to the public health and safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may issue an order suspending this chapter for covered baby bumper pads if the Consumer Product Safety Commission affirmatively finds that the benefits of certain baby bumper pads exceed the risks.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Violations."> <paragraph num="A."> <text>A notice of violation will be issued by the Department to any person found to have shipped or sold a baby bumper pad to a purchaser in Maryland after June 21, 2013.</text> </paragraph> <paragraph num="B."> <text>A person who, after being issued a notice of violation, ships or sells a baby bumper pad to a purchaser in Maryland shall be subject to a civil fine of not more than $500 for each baby bumper pad shipped or sold in violation of this subtitle.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §22-501 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 26, 2012 (39:23 Md R. 1532)</annotation> </annotations> </chapter> <chapter num="08" heading="Sensitive Health Services"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter:</text> <paragraph num="A."> <text>Defines:</text> <paragraph num="(1)"> <text>Mifepristone data;</text> </paragraph> <paragraph num="(2)"> <text>Health information exchange;</text> </paragraph> <paragraph num="(3)"> <text>Electronic health network; and</text> </paragraph> <paragraph num="(4)"> <text>Protected Health Care Commission;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Lists the:</text> <paragraph num="(1)"> <text>Mifepristone data, and diagnosis, procedure, and related codes for abortion care that are subject to the restrictions on the disclosure of health care information; and</text> </paragraph> <paragraph num="(2)"> <text>Diagnosis, procedure, and related codes for gender-affirming treatment that are subject to the restrictions on the disclosure of health care information;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Describes to whom these restrictions apply; and</text> </paragraph> <paragraph num="D."> <text>Sets forth the restrictions on data.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Electronic health network” has the meaning stated in COMAR 10.25.09.02.</text> </paragraph> <paragraph num="(2)"> <text>“Gender-affirming treatment” has the meaning stated in Health-General Article, §15-151, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Health information exchange” has the meaning stated in COMAR 10.25.18.02.</text> </paragraph> <paragraph num="(4)"> <text>“Mifepristone data” means all medication or related codes pertaining to mifepristone use during any stage of pregnancy, and excludes any codes pertaining to the use of mifepristone for Cushing’s syndrome.</text> </paragraph> <paragraph num="(5)"> <text>“Protected Health Care Commission” means the group established under Health-General Article, §4-310, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Secretary” means the Secretary of the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Abortion Care Codes."> <text>A health information exchange and an electronic health network shall restrict the disclosure of the abortion care medical diagnosis codes and current procedural terminology (CPT) codes listed in the tables below.</text> <paragraph num="A."> <text>List of Medical Diagnosis Codes.</text> </paragraph> <paragraph num="B."> <text>List of the Current Procedural Terminology (CPT®) Codes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Mifepristone Data Codes."> <text>A health information exchange and an electronic health network shall restrict the disclosure of mifepristone data Healthcare Common Procedure Coding System (HCPCS) codes and medication codes listed in the tables below.</text> <paragraph num="A."> <text>List of Healthcare Common Procedure Coding System ( HCPCS) Level 2 Codes.</text> </paragraph> <paragraph num="B."> <text>List of Medication Codes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Restrictions on Disclosure of Mifepristone Data."> <text>Data is restricted in accordance with COMAR 10.25.18 and COMAR 10.25.07.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Gender-Affirming Treatment Codes."> <paragraph num="A."> <text>A health information exchange and an electronic health network shall restrict the disclosure of the gender-affirming treatment medical diagnosis codes and current procedural terminology (CPT) codes listed in §B below.</text> </paragraph> <paragraph num="B."> <text>List of Medical Diagnosis Codes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sensitive Health Services."> <text>The Secretary shall determine what sensitive health services are subject to restriction under this chapter based on the recommendations of the Protected Health Care Commission.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-302.5 Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 16, 2024 (51:18 Md. R. 809)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 recodified to Regulation .07 effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> </subtitle> <subtitle num="12" heading="Adult Health"> <chapter num="01" heading="Surgical Abortion Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Facility” means a surgical abortion facility.</text> </paragraph> <paragraph num="(3)"> <text>Health Professional.</text> <paragraph num="(a)"> <text>“Health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services.</text> </paragraph> <paragraph num="(b)"> <text>“Health professional” does not include a physician.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Regular service” means that surgical abortion procedures are performed on site on a routine basis.</text> </paragraph> <paragraph num="(6)"> <text>“Surgical abortion facility” means an outpatient facility that provides surgical termination of pregnancy as a regular service except if the facility is regulated by the Department under:</text> <paragraph num="(a)"> <text>Health General Article, Title 19, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Health General Article, Title 19, Subtitle 3A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Health General Article, Title 19, Subtitle 3B, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Required."> <paragraph num="A."> <text>A person may not establish or operate a surgical abortion facility without obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary.</text> </paragraph> <paragraph num="C."> <text>A license issued under this chapter is not transferable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedures."> <paragraph num="A."> <text>A person desiring to operate a facility shall:</text> <paragraph num="(1)"> <text>Be in compliance with all applicable federal and State laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>File an application as required and provided by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a written description of its quality assurance program as required by Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to meeting all of the requirements of Regulation .03A and F of this chapter, the applicant or licensee shall submit a nonrefundable fee of $1,500 with an application for:</text> <paragraph num="(1)"> <text>An initial license; or</text> </paragraph> <paragraph num="(2)"> <text>A license renewal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application unconditionally;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application conditionally; or</text> </paragraph> <paragraph num="(3)"> <text>Deny the application if the applicant:</text> <paragraph num="(a)"> <text>Has been found liable for or has been convicted of:</text> <paragraph num="(i)"> <text>Fraud or a felony that relates to Medicaid or Medicare; or</text> </paragraph> <paragraph num="(ii)"> <text>A crime involving moral turpitude; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Denial of License for Prior Revocation or Consent to Surrender License.</text> <paragraph num="(1)"> <text>The Secretary may deny a license to:</text> <paragraph num="(a)"> <text>A corporate applicant if the corporate entity has an owner, director, or officer:</text> <paragraph num="(i)"> <text>Whose conduct caused the revocation of a prior license; or</text> </paragraph> <paragraph num="(ii)"> <text>Who held the same or similar position in another corporate entity which had its license revoked;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual applicant:</text> <paragraph num="(i)"> <text>Whose conduct caused the revocation of a prior license; or</text> </paragraph> <paragraph num="(ii)"> <text>Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary shall also consider the factors identified in Regulation .19B of this chapter when deciding whether to deny a license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Renewal of License.</text> <paragraph num="(1)"> <text>At least 60 days before a license expires, the licensee shall submit to the Secretary:</text> <paragraph num="(a)"> <text>A renewal application; and</text> </paragraph> <paragraph num="(b)"> <text>The fee as specified in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Inspections by the Department."> <paragraph num="A."> <text>Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to:</text> <paragraph num="(1)"> <text>Verify compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Investigate a complaint concerning patient care and safety as described in §B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Complaints.</text> <paragraph num="(1)"> <text>In response to a complaint, the Department may:</text> <paragraph num="(a)"> <text>Require the facility to perform and submit its own investigation; or</text> </paragraph> <paragraph num="(b)"> <text>In its discretion, conduct an on-site investigation of a complaint.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to determine whether an on-site investigation as described in §B(1)(b) of this regulation is appropriate, the factors the Department shall consider include, but are not limited to:</text> <paragraph num="(a)"> <text>Whether the complainant has first-hand knowledge of the alleged incident;</text> </paragraph> <paragraph num="(b)"> <text>The facility's regulatory history, including the number of verified prior complaints;</text> </paragraph> <paragraph num="(c)"> <text>Whether the Department has recently inspected the facility, and whether the incident would have been observed during the prior review; and</text> </paragraph> <paragraph num="(d)"> <text>The nature of the complaint, including degree of potential serious harm to patients.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the complaint concerns the performance of a physician, health professional, or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the physician or health professional to provide services under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Comply with the requirements for medical review committees as described in Health Occupations Article, §1-401, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Keep patient information confidential in accordance with State and federal laws.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Noncompliance. If the Department determines that a facility fails to meet any provision of this chapter, the Department shall:</text> <paragraph num="(1)"> <text>Advise the facility of the exact nature of the violation; and</text> </paragraph> <paragraph num="(2)"> <text>Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Records and Reports. The facility shall make its records and reports available to the Department on site at the facility during an inspection.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Administration."> <paragraph num="A."> <text>Administrator.</text> <paragraph num="(1)"> <text>Each facility shall have an administrator, who is responsible for the daily operation of the facility, including but not limited to:</text> <paragraph num="(a)"> <text>Consulting with the staff to develop and implement the facility's policies and procedures required under §C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Organizing and coordinating the administrative functions of the facility;</text> </paragraph> <paragraph num="(c)"> <text>Coordinating the provision of services that the facility provides;</text> </paragraph> <paragraph num="(d)"> <text>Training the staff on the facility's policies and procedures and applicable federal, State, and local laws and regulations; and</text> </paragraph> <paragraph num="(e)"> <text>Ensuring that all personnel:</text> <paragraph num="(i)"> <text>Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties, including proper infection control practices;</text> </paragraph> <paragraph num="(ii)"> <text>Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and</text> </paragraph> <paragraph num="(iii)"> <text>Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The administrator shall ensure that:</text> <paragraph num="(a)"> <text>The facility's policies and procedures as described in §C of this regulation are:</text> <paragraph num="(i)"> <text>Reviewed by staff at least annually and are revised as necessary; and</text> </paragraph> <paragraph num="(ii)"> <text>Available at all times for staff inspection and reference; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>All appropriate personnel implement all policies and procedures as adopted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director.</text> <paragraph num="(1)"> <text>The surgical abortion facility shall have a medical director who:</text> <paragraph num="(a)"> <text>Is responsible for the overall medical care that is provided by the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Advises and consults with the staff of the facility on all medical issues relating to services provided by the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The medical director shall be a physician licensed to practice in Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Policies and Procedures. The facility shall have policies and procedures concerning the following:</text> <paragraph num="(1)"> <text>The scope and delivery of services provided by the facility either directly or through contractual arrangements;</text> </paragraph> <paragraph num="(2)"> <text>Personnel practices, including but not limited to:</text> <paragraph num="(a)"> <text>Procedures for the accountability of personnel involved in patient care;</text> </paragraph> <paragraph num="(b)"> <text>Job descriptions on file for all personnel: and</text> </paragraph> <paragraph num="(c)"> <text>Procedures to ensure personnel are free from communicable diseases;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Postoperative recovery, if applicable;</text> </paragraph> <paragraph num="(4)"> <text>The transfer or referral of patients who require services that are not provided by the facility;</text> </paragraph> <paragraph num="(5)"> <text>Infection control for patients and staff;</text> </paragraph> <paragraph num="(6)"> <text>Pertinent safety practices, including the control of fire and mechanical hazards;</text> </paragraph> <paragraph num="(7)"> <text>Preventive maintenance for equipment to ensure proper operation and safety; and</text> </paragraph> <paragraph num="(8)"> <text>The services and procedures specified in Regulations .07—.12 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Personnel."> <paragraph num="A."> <text>Qualifications of Physicians and Staff. A facility shall ensure that all physicians and other health professionals who are employees or contractual staff have been appropriately trained and licensed or certified under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Credentialing of Physicians. The facility shall collect, review, and document the following information concerning a physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>The physician's education;</text> </paragraph> <paragraph num="(2)"> <text>The professional experience of the physician, including:</text> <paragraph num="(a)"> <text>Any board certification or specialty training of the physician; and</text> </paragraph> <paragraph num="(b)"> <text>Any post-graduate training;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Any license or registration to practice a health occupation ever held by the physician, including DEA registration;</text> </paragraph> <paragraph num="(4)"> <text>Any hospital where the physician was appointed or employed during the last 10 years, including:</text> <paragraph num="(a)"> <text>The name of the hospital;</text> </paragraph> <paragraph num="(b)"> <text>The term of appointment or employment; and</text> </paragraph> <paragraph num="(c)"> <text>Privileges held and any disciplinary action taken, including suspension, revocation, limitation, or voluntary surrender;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The physician's professional liability insurance for the last 5 years, including:</text> <paragraph num="(a)"> <text>The physician's present carrier;</text> </paragraph> <paragraph num="(b)"> <text>The physician's current limits of coverage;</text> </paragraph> <paragraph num="(c)"> <text>The physician's current types of coverage; and</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on the physician's coverage;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Any claim that has been made against the physician in the practice of a health occupation in the last 5 years, and the status of the claim;</text> </paragraph> <paragraph num="(7)"> <text>Any physical or mental condition that currently impairs the physician's ability to exercise privileges;</text> </paragraph> <paragraph num="(8)"> <text>Any complaint or report, permitted to be disclosed by law, which has been filed with any state licensing or disciplinary body, or comparable body of the armed forces; and</text> </paragraph> <paragraph num="(9)"> <text>Data provided by the National Practitioner Data Bank.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For a physician who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>The administrator shall establish a procedure for the biennial reappointment of a physician which includes:</text> <paragraph num="(1)"> <text>An update of the information required in §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>An assessment of the physician's performance pattern based on an analysis of:</text> <paragraph num="(a)"> <text>Complaints filed with the facility;</text> </paragraph> <paragraph num="(b)"> <text>Malpractice claims filed;</text> </paragraph> <paragraph num="(c)"> <text>Utilization, quality, and risk data;</text> </paragraph> <paragraph num="(d)"> <text>Adherence to policies, bylaws, and procedures; and</text> </paragraph> <paragraph num="(e)"> <text>Physician practice patterns as reviewed through the facility's quality assurance program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Credentialing of Health Professionals.</text> <paragraph num="(1)"> <text>Direct Hires.</text> <paragraph num="(a)"> <text>The facility shall collect, review, and verify evidence of the following information for all licensed or certified health professionals that are employed by the facility:</text> <paragraph num="(i)"> <text>A current license or certificate to practice in this State; and</text> </paragraph> <paragraph num="(ii)"> <text>Malpractice insurance, if required by the facility.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The administrator shall approve the delineation of services to be provided by the health professional.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nondirect Hires. When a licensed physician uses a health professional to provide services at the facility, and that person is not employed by the facility, the licensed physician who employs the health professional is responsible for verifying the information required in §E(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Surgical Abortion Services."> <paragraph num="A."> <text>Surgical abortion procedures shall be performed in a safe manner by a physician credentialed by the facility under Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>An administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical abortion services including but not limited to:</text> <paragraph num="(1)"> <text>Personnel;</text> </paragraph> <paragraph num="(2)"> <text>Pre-operative testing and examinations;</text> </paragraph> <paragraph num="(3)"> <text>Surgical procedures;</text> </paragraph> <paragraph num="(4)"> <text>Post-anesthesia care and observation;</text> </paragraph> <paragraph num="(5)"> <text>Discharge planning;</text> </paragraph> <paragraph num="(6)"> <text>Emergency services;</text> </paragraph> <paragraph num="(7)"> <text>Informed consent; and</text> </paragraph> <paragraph num="(8)"> <text>Safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The administrator shall ensure that the policies, procedures and protocols referenced in §B of this regulation are:</text> <paragraph num="(1)"> <text>Available on site at all times for reference; and</text> </paragraph> <paragraph num="(2)"> <text>Reviewed annually and revised as necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before conducting a surgical procedure, a physician or other qualified health professional shall conduct a history and physical examination.</text> </paragraph> <paragraph num="E."> <text>If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a health practitioner as described in Regulation .08 of this chapter shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient.</text> </paragraph> <paragraph num="F."> <text>If the assessments required by §§D and E of this regulation are performed before the day of surgery, on the day of surgery a physician or qualified health professional shall reassess and document on the patient’s medical record any change in the patient's clinical status that could have an effect on the surgical procedure to be performed and the anesthesia to be used.</text> </paragraph> <paragraph num="G."> <text>Discharge. Before discharge from the facility, the patient shall be evaluated by a physician or an appropriately trained health professional. This evaluation shall be documented in the patient’s record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Anesthesia Services."> <paragraph num="A."> <text>Anesthetics shall be administered by health practitioners who are licensed, certified, or otherwise authorized to do so under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Anesthetics shall be administered only by a:</text> <paragraph num="(1)"> <text>Qualified anesthesiologist;</text> </paragraph> <paragraph num="(2)"> <text>A physician qualified to administer anesthesia; or</text> </paragraph> <paragraph num="(3)"> <text>A certified registered nurse anesthetist in accordance with:</text> <paragraph num="(a)"> <text>Health Occupations Article, §8-205, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.27.06.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Emergency Services."> <paragraph num="A."> <text>Basic Life Support. Licensed personnel employed by the facility shall have certification in basic life support. A licensed staff individual trained in basic life support shall be on duty whenever there is a patient in the facility.</text> </paragraph> <paragraph num="B."> <text>The facility shall have:</text> <paragraph num="(1)"> <text>A registered nurse available on site for emergency treatment whenever there is a post-operative surgical abortion patient in the facility; and</text> </paragraph> <paragraph num="(2)"> <text>At least one physician available by phone 24 hours a day to respond to emergency situations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When sedation or general anesthesia is administered, the facility shall have at least the following emergency equipment available to the procedure rooms:</text> <paragraph num="(1)"> <text>Oxygen;</text> </paragraph> <paragraph num="(2)"> <text>Mechanical ventilatory assistance including airways and manual breathing bag;</text> </paragraph> <paragraph num="(3)"> <text>Automated external defibrillator (AED);</text> </paragraph> <paragraph num="(4)"> <text>Equipment to monitor blood pressure, pulse, and oxygen levels;</text> </paragraph> <paragraph num="(5)"> <text>Suction equipment; and</text> </paragraph> <paragraph num="(6)"> <text>Emergency medical equipment and supplies specified by the medical staff.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When general anesthesia is administered, a facility shall have available in the procedure room:</text> <paragraph num="(1)"> <text>Laryngoscopes;</text> </paragraph> <paragraph num="(2)"> <text>Endotracheal tubes; and</text> </paragraph> <paragraph num="(3)"> <text>Cardiac monitoring equipment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Hospitalization."> <paragraph num="A."> <text>The surgical abortion facility shall have an effective procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required.</text> </paragraph> <paragraph num="B."> <text>Procedures for emergency transfer to a hospital shall include, at a minimum:</text> <paragraph num="(1)"> <text>Written protocols and procedures related to emergency transfer procedures;</text> </paragraph> <paragraph num="(2)"> <text>A mechanism for notifying the hospital of a pending emergency case;</text> </paragraph> <paragraph num="(3)"> <text>A mechanism for arranging appropriate transportation to the hospital;</text> </paragraph> <paragraph num="(4)"> <text>Protocols for transmitting a copy of the patient's medical record to the hospital; and</text> </paragraph> <paragraph num="(5)"> <text>Appropriate training for staff in the facility’s written protocols and procedures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Pharmaceutical Services."> <paragraph num="A."> <text>The surgical abortion facility shall:</text> <paragraph num="(1)"> <text>Provide drugs under the direction of an authorized prescriber; and</text> </paragraph> <paragraph num="(2)"> <text>Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Administration of Drugs.</text> <paragraph num="(1)"> <text>Staff shall prepare and administer drugs according to established policies and acceptable standards of practice.</text> </paragraph> <paragraph num="(2)"> <text>Staff shall report adverse drug reactions to the licensee's medical director or physician.</text> </paragraph> <paragraph num="(3)"> <text>Orders given orally for drugs shall be followed by a written order which is signed by the authorized prescriber.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Laboratory and Radiologic Services."> <paragraph num="A."> <text>The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiological services to meet the needs of the patient. Policies and procedures shall include:</text> <paragraph num="(1)"> <text>Turn-around time;</text> </paragraph> <paragraph num="(2)"> <text>Review of laboratory reports; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of laboratory results.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Laboratory facilities shall be:</text> <paragraph num="(1)"> <text>Approved under the Clinical Laboratory Improvement Act (CLIA); and</text> </paragraph> <paragraph num="(2)"> <text>Licensed by the State under COMAR 10.10.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The facility shall include in the patient's medical records:</text> <paragraph num="(1)"> <text>Laboratory reports; and</text> </paragraph> <paragraph num="(2)"> <text>Radiological findings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Medical Records."> <paragraph num="A."> <text>The facility shall maintain a complete, comprehensive, and accurate medical record for a patient.</text> </paragraph> <paragraph num="B."> <text>A patient's medical record shall include at least the following:</text> <paragraph num="(1)"> <text>Patient identifier;</text> </paragraph> <paragraph num="(2)"> <text>Significant medical history and results of a physical examination;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of care or services provided;</text> </paragraph> <paragraph num="(4)"> <text>Evidence of consent; and</text> </paragraph> <paragraph num="(5)"> <text>Discharge diagnosis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>With the patient's consent or to the extent that information in a record is necessary for a patient's care in an emergency transfer, the facility shall:</text> <paragraph num="(1)"> <text>Send a copy of the medical record with the patient on:</text> <paragraph num="(a)"> <text>Referral to another physician or other licensed health professional; or</text> </paragraph> <paragraph num="(b)"> <text>Transfer to a hospital;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If appropriate, and with the patient's consent, use the medical record when instructing the patient and the family; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Patients’ Rights and Responsibilities"> <text>The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients’ rights and responsibilities, including but not limited to:</text> <paragraph num="A."> <text>The opportunity to participate in planning their medical treatment; and</text> </paragraph> <paragraph num="B."> <text>Confidentiality of medical records and the right to approve or refuse release of records to any individual outside the facility, except as provided by federal or State law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Physical Environment."> <paragraph num="A."> <text>The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services.</text> </paragraph> <paragraph num="B."> <text>A procedure room shall be designed and equipped to ensure that surgical abortion procedures conducted can be performed in a manner that ensures the safety of all individuals in the area.</text> </paragraph> <paragraph num="C."> <text>The facility shall have a separate recovery room and waiting area.</text> </paragraph> <paragraph num="D."> <text>The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Quality Assurance Program."> <paragraph num="A."> <text>The administrator shall ensure that the facility develops and maintains a quality assurance program which includes:</text> <paragraph num="(1)"> <text>Monitoring and evaluation of the quality of patient care; and</text> </paragraph> <paragraph num="(2)"> <text>Identification, evaluation, and resolution of care problems.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.</text> </paragraph> <paragraph num="C."> <text>The administrator shall ensure that the facility develops a quality control procedure to monitor and document the safety and performance of all biomedical equipment.</text> </paragraph> <paragraph num="D."> <text>The facility shall document the following information for all quality assurance activities:</text> <paragraph num="(1)"> <text>A description of identified problems;</text> </paragraph> <paragraph num="(2)"> <text>Findings;</text> </paragraph> <paragraph num="(3)"> <text>Conclusions;</text> </paragraph> <paragraph num="(4)"> <text>Recommendations;</text> </paragraph> <paragraph num="(5)"> <text>Actions taken;</text> </paragraph> <paragraph num="(6)"> <text>Results; and</text> </paragraph> <paragraph num="(7)"> <text>Follow-up.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the licensee:</text> <paragraph num="(1)"> <text>Informing the licensee of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is immediately suspended, the licensee shall:</text> <paragraph num="(1)"> <text>Immediately return the license to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Stop providing surgical abortion procedures immediately.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Hearing.</text> <paragraph num="(1)"> <text>The Office on Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Conduct a hearing as set forth in Regulation .20 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a proposed decision within 10 business days of the close of the hearing record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Final Decision.</text> <paragraph num="(1)"> <text>The Secretary shall make a final decision in accordance with COMAR 10.01.03.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Revocation of License."> <paragraph num="A."> <text>The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Secretary may revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Has been convicted of:</text> <paragraph num="(a)"> <text>Fraud or a felony that relates to Medicaid or Medicare; or</text> </paragraph> <paragraph num="(b)"> <text>A crime involving moral turpitude; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall consider the factors identified in Regulation .19B of this chapter when deciding whether to revoke a license.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall notify the licensee in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the licensee is entitled to a hearing, if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the facility shall stop providing surgical abortion services on the effective date of the revocation if the licensee does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the licensee is required to surrender the license to the Department if the revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Penalties."> <paragraph num="A."> <text>Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter.</text> </paragraph> <paragraph num="B."> <text>When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violation or violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, §§10-201—10-227, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-209, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 23, 2012 (39:14 Md. R. 835)</annotation> </annotations> </chapter> <chapter num="02" heading="Rape and Sexual Offenses — Physician and Hospital Charges"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations outline the requirements for the collection of evidence in cases of alleged rape, sexual offense, and child sexual abuse and for reimbursement to hospitals, laboratories, and physicians for the physical examination of, the collection of evidence from, and the emergency treatment of individuals for physical injuries directly resulting from the alleged rape or sexual assault and for an initial assessment, and information and evidence collection, of a victim of alleged child sexual abuse.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Child” means any individual younger than 18 years old.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Emergency hospital treatment” means the provision of those services which are medically necessary to treat the victim's physical health or alleviate the victim's severe pain or discomfort.</text> </paragraph> <paragraph num="(4)"> <text>“Examination” means a medical examination, including the necessary tests, for the purpose of establishing and gathering information and evidence as to the alleged rape or sexual offense only.</text> </paragraph> <paragraph num="(4-1)"> <text>“Forensic nurse examiner” means a registered nurse examiner certified by the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>Initial Assessment.</text> <paragraph num="(a)"> <text>“Initial assessment” means an appraisal for the purpose of establishing and gathering information and evidence as to alleged child sexual abuse.</text> </paragraph> <paragraph num="(b)"> <text>“Initial assessment” includes a:</text> <paragraph num="(i)"> <text>Psychological evaluation;</text> </paragraph> <paragraph num="(ii)"> <text>Parental interview; and</text> </paragraph> <paragraph num="(iii)"> <text>Medical evaluation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Interdisciplinary team expert in the field of child abuse” means a licensed physician, psychologist, social worker, nurse practitioner, nurse, or mental health professional working in a setting that specializes in child abuse.</text> </paragraph> <paragraph num="(7)"> <text>“Mental health professional” means a board-eligible or board-certified psychiatrist, a licensed psychologist, or a person with a minimum of a master's degree and clinical training in an accepted mental health field, including the fields of counseling, nursing, occupational therapy, psychology, and social work.</text> </paragraph> <paragraph num="(8)"> <text>“Physician” means a person licensed to practice medicine in Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Provider” means a physician, hospital, or laboratory.</text> </paragraph> <paragraph num="(10)"> <text>“Qualified hospital health care personnel” means a licensed employee of a hospital licensed by the State.</text> </paragraph> <paragraph num="(11)"> <text>“Rape” means a criminal act of vaginal intercourse as defined under Criminal Law Article, §§3-303 and 304, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>Sexual Abuse.</text> <paragraph num="(a)"> <text>“Sexual abuse” means an act that involves sexual molestation or exploitation of a child whether or not the sexual molestation or exploitation of the child is by a parent or other person who has permanent or temporary care, or custody or responsibility for supervision of a child, or by a household or family member.</text> </paragraph> <paragraph num="(b)"> <text>“Sexual abuse” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Incest, rape, or sexual offense in any degree;</text> </paragraph> <paragraph num="(ii)"> <text>Sodomy; and</text> </paragraph> <paragraph num="(iii)"> <text>Unnatural or perverted sexual practices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Sexual offense” means a criminal sexual act or sexual contact as defined under Criminal Law Article, §§3-305—3-308, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Victim” means a person who is alleged to be the subject of rape, sexual offense, or child sexual abuse.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Alleged Rape or Sexual Offense Victim Care."> <paragraph num="A."> <text>The victim shall be considered an emergency patient with special needs. The victim shall be taken immediately to a quiet private area where tests and examinations will be performed on the victim. The following measures are indicated under certain circumstances:</text> <paragraph num="(1)"> <text>Prophylactic medication shall be discussed and offered to the victim who is at risk for pregnancy as a result of the alleged rape or sexual assault;</text> </paragraph> <paragraph num="(2)"> <text>Prophylactic medication shall be discussed and offered to the victim who is at risk for sexually transmitted infections and recommended initial tests and follow-up tests shall be performed, if indicated;</text> </paragraph> <paragraph num="(3)"> <text>After the victim has been properly informed as to the significance of testing for the presence of the human immunodeficiency virus (HIV), the victim shall be referred to the appropriate anonymous or confidential, and free HIV counseling and test sites for potential baseline and follow-up testing and support services;</text> </paragraph> <paragraph num="(4)"> <text>Injuries suffered by the victim shall be treated with appropriate consultation, as necessary; and</text> </paragraph> <paragraph num="(5)"> <text>Tetanus prophylaxis may be administered, if indicated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Sexual Assault.</text> <paragraph num="(1)"> <text>A sexual assault forensic examination shall be performed if:</text> <paragraph num="(a)"> <text>The victim is seen within 120 hours of the alleged sexual offense; and</text> </paragraph> <paragraph num="(b)"> <text>Either:</text> <paragraph num="(i)"> <text>A police report has been filed with the appropriate law enforcement jurisdiction; or</text> </paragraph> <paragraph num="(ii)"> <text>A property-held number is assigned to the case in the event that a victim does not wish to file a police report immediately but still seeks to have evidence collected and held.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A sexual assault forensic examination shall be performed only by a:</text> <paragraph num="(a)"> <text>Physician; or</text> </paragraph> <paragraph num="(b)"> <text>Forensic nurse examiner.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When performing a sexual assault forensic examination, a physician or a forensic nurse examiner shall use the Maryland State Police victim sexual assault evidence collection kit or a comparable evidence collection kit and shall follow the kit instructions including:</text> <paragraph num="(a)"> <text>Packaging the victim's clothing in paper bags; and</text> </paragraph> <paragraph num="(b)"> <text>Collecting the following specimens:</text> <paragraph num="(i)"> <text>Blood sample (lavender cap);</text> </paragraph> <paragraph num="(ii)"> <text>Vaginal swabs (a minimum of four);</text> </paragraph> <paragraph num="(iii)"> <text>Oral swabs (a minimum of two);</text> </paragraph> <paragraph num="(iv)"> <text>Pubic hair combings;</text> </paragraph> <paragraph num="(v)"> <text>Pulled pubic hair;</text> </paragraph> <paragraph num="(vi)"> <text>Pulled head hair; and</text> </paragraph> <paragraph num="(vii)"> <text>If indicated, anal swabs, bite mark swabs, and fingernail scrapings.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A physician or forensic nurse examiner shall follow the procedures as indicated to establish evidence of alleged rape or sexual offense, depending on the specifics of the crime as described by the victim:</text> <paragraph num="(1)"> <text>Obtain from each of the following areas, if indicated, a smear to be fixed and stained according to the Papanicolaou technique:</text> <paragraph num="(a)"> <text>Endocervical canal;</text> </paragraph> <paragraph num="(b)"> <text>Vaginal pool;</text> </paragraph> <paragraph num="(c)"> <text>Vulva;</text> </paragraph> <paragraph num="(d)"> <text>Mouth; and</text> </paragraph> <paragraph num="(e)"> <text>Anal area;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Obtain culture for gonorrhea from cervix, rectum, and nasopharynx, if indicated, and plate it immediately;</text> </paragraph> <paragraph num="(3)"> <text>Obtain vaginal, oral, or rectal aspirate for acid phosphatase testing, if indicated;</text> </paragraph> <paragraph num="(4)"> <text>Obtain a blood sample for syphillis testing and refer patient to a healthcare provider of choice for repeat sample in 4 — 6 weeks;</text> </paragraph> <paragraph num="(5)"> <text>Obtain X-rays necessary to establish evidence of physical injuries sustained as a direct result of the alleged rape or sexual offense; and</text> </paragraph> <paragraph num="(6)"> <text>Obtain either a urine sample or a blood sample for beta subunit of human chorionic gonadotropin for a pregnancy test and recommend and refer the victim to a healthcare provider of choice for a second test in 4—6 weeks, if indicated.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A physician or forensic nurse examiner shall submit the evidence collected to the appropriate law enforcement jurisdiction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Alleged Child Sexual Abuse Victim Care."> <paragraph num="A."> <text>The professional involved in the care of the victim of alleged child sexual abuse shall make every effort to minimize additional physical or emotional trauma to the child.</text> </paragraph> <paragraph num="B."> <text>The following protocol is recommended for the initial assessment:</text> <paragraph num="(1)"> <text>A history of the child shall be obtained from the parent, guardian, or custodian separately from the child, if possible, and shall:</text> <paragraph num="(a)"> <text>Minimize repetitive questioning of the child;</text> </paragraph> <paragraph num="(b)"> <text>Recognize that the child is often threatened and afraid to tell; and</text> </paragraph> <paragraph num="(c)"> <text>Include a review of behavior relevant to sexual abuse;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A physician or forensic nurse examiner shall perform a thorough pediatric physical examination on the child in the presence of a supportive adult not suspected of being party to the abuse and a physician or forensic nurse examiner shall:</text> <paragraph num="(a)"> <text>Use gentleness, time, sedation, or general anesthesia if absolutely necessary;</text> </paragraph> <paragraph num="(b)"> <text>Note evidence of physical abuse and injuries;</text> </paragraph> <paragraph num="(c)"> <text>Avoid internal anogenital examinations except when internal injuries are suspected;</text> </paragraph> <paragraph num="(d)"> <text>Perform a gender specific examination on the male child to include:</text> <paragraph num="(i)"> <text>Examining thighs, penis, scrotum, testes, and anus for evidence of injury and infection, and</text> </paragraph> <paragraph num="(ii)"> <text>Noting Tanner stage;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Perform a gender specific examination on the female child to include:</text> <paragraph num="(i)"> <text>Examining thighs, labia majora and minora, clitoris, urethra, hymen and vaginal wall (especially posteriorly) for evidence of injury and infection and noting horizontal hymenal opening diameter;</text> </paragraph> <paragraph num="(ii)"> <text>Maintaining a frog-leg position during the examination; and</text> </paragraph> <paragraph num="(iii)"> <text>Noting Tanner stage;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Perform a routine pelvic examination on the postpubertal female child only if the victim has had a previous pelvic examination;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Depending on the specifics of the individual case and exercising best professional judgment, a physician or forensic nurse examiner may perform a rape examination if the child is seen within 120 hours of alleged sexual abuse, and the examination shall:</text> <paragraph num="(a)"> <text>Include only applicable parts of the rape kit; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the chain of custody of evidence;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The physician or forensic nurse examiner shall obtain laboratory tests when the tests are indicated from information obtained through the child's history or physical examination;</text> </paragraph> <paragraph num="(5)"> <text>A psychological assessment shall include:</text> <paragraph num="(a)"> <text>A review of what happened to the child from the child's perspective;</text> </paragraph> <paragraph num="(b)"> <text>The use of play, dolls, or drawings as a way for the younger child to communicate what happened to the child;</text> </paragraph> <paragraph num="(c)"> <text>An assessment of the effect of the alleged sexual abuse on the child; and</text> </paragraph> <paragraph num="(d)"> <text>A developmentally age-appropriate description of the psychological findings and any indications for follow-up care;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An interview with a parent, guardian, or custodian shall include a:</text> <paragraph num="(a)"> <text>Review from the parent's, guardian's, or custodian's understanding of the alleged child abuse;</text> </paragraph> <paragraph num="(b)"> <text>Description of any behavioral manifestations that may be observed in the child such as fears, clinging, sleep disturbances, bed-wetting, somatic complaints, or school problems; and</text> </paragraph> <paragraph num="(c)"> <text>Discussion of anticipated medical or investigative follow-up, or both, pursuant to Family Law Article, Title 5, Subtitle 7, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Professionals qualified to gather information and evidence as part of the initial assessment include:</text> <paragraph num="(a)"> <text>A physician;</text> </paragraph> <paragraph num="(b)"> <text>Qualified hospital health care personnel;</text> </paragraph> <paragraph num="(c)"> <text>A mental health professional; and</text> </paragraph> <paragraph num="(d)"> <text>An interdisciplinary team expert in the field of child abuse.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reimbursements."> <paragraph num="A."> <text>Restrictions. A provider:</text> <paragraph num="(1)"> <text>May not charge the victim or the victim's family of an alleged rape, sexual offense, or child sexual abuse for a physical examination or an initial assessment for the purpose of establishing and gathering information and evidence as to the alleged crime or for emergency hospital treatment and follow-up medical testing performed up to 90 days after the initial physical examination;</text> </paragraph> <paragraph num="(2)"> <text>May not bill a victim of an alleged rape, sexual offense, or child sexual abuse, or the victim's family or private insurance, for any difference between charges and Department reimbursement; and</text> </paragraph> <paragraph num="(3)"> <text>Shall accept the Department's reimbursement as payment in full.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Physicians Providing Services to Victims of Alleged Rape or Sexual Offense.</text> <paragraph num="(1)"> <text>The Department shall pay a physician the physician's usual and customary fee not to exceed $80 for examination and collection of evidence, if the following are submitted to the Maryland Department of Health, Center for Health Promotion, 300 West Preston Street, Suite # 410, Baltimore, MD 21201:</text> <paragraph num="(a)"> <text>The forms found in the Maryland State Police sexual assault kit, or comparable evidence collection kit, which are:</text> <paragraph num="(i)"> <text>Filled out completely;</text> </paragraph> <paragraph num="(ii)"> <text>Typed or legibly written;</text> </paragraph> <paragraph num="(iii)"> <text>Signed and dated by the examining physician; and</text> </paragraph> <paragraph num="(iv)"> <text>Bearing the police central complaint number or a similar police case identifier or a property-held number in accordance with Regulation .03B(1)(b) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A completed MDH form 2923, as developed by the Department, containing the signature of the victim or the victim's representative, indicating informed consent for medical examination, collection of evidence, and release of information.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall pay the physician's usual and customary fee for consultation and for rendering emergency hospital treatment and necessary follow-up medical testing obtained within 90 days of the initial physical examination, for injuries sustained as a result of alleged rape or sexual assault.</text> </paragraph> <paragraph num="(3)"> <text>If there is a physician's fee component in the emergency room rate as established by the Health Services Cost Review Commission, there is no additional payment for the physician.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physicians Providing Services to Victims of Alleged Child Sexual Abuse.</text> <paragraph num="(1)"> <text>The Department shall pay a physician the physician's usual and customary fee or the customary fee of those individuals under the physician's supervision, qualified to participate in the gathering of information and evidence through an initial assessment as defined under Regulation .02B of this chapter, not to exceed $80 per hour for up to 5 hours. The Department shall pay a physician only if a report:</text> <paragraph num="(a)"> <text>Is filled out completely as to the assessment done;</text> </paragraph> <paragraph num="(b)"> <text>Is typed or legibly written;</text> </paragraph> <paragraph num="(c)"> <text>Is signed and dated by the physician or cosigned by the physician and other qualified professionals providing services;</text> </paragraph> <paragraph num="(d)"> <text>Includes the police central complaint number, a property-held number, or other case identifier; and</text> </paragraph> <paragraph num="(e)"> <text>Includes either a completed MDH Form 2923 or 4456, as developed by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If there is a physician's fee component in the emergency room or outpatient clinic rate as established by the Health Services Cost Review Commission, there is no additional payment for the physician.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Hospital. The Department shall pay the established rate as determined by the Health Services Cost Review Commission for the use of the emergency room or outpatient clinic and the daily in-hospital rate in case of hospitalization for physical injuries directly resulting from the alleged sexual assault or abuse.</text> </paragraph> <paragraph num="E."> <text>Laboratory. The Department shall pay the established rate as defined by the Health Services Cost Review Commission for laboratory tests necessary to establish and gather information and evidence of the crime, and for screening of the victim for pregnancy and sexually transmitted infections.</text> </paragraph> <paragraph num="F."> <text>Billing.</text> <paragraph num="(1)"> <text>Except as provided in §F(3) of this regulation, in order to get paid a provider shall submit itemized bills to the Department within 90 days of the rendering of care.</text> </paragraph> <paragraph num="(2)"> <text>If a provider submits a bill more than 90 days but less than 180 days after the initial physical examination, the provider shall submit a written request for payment stating the specific reasons why the itemized bills were not timely submitted in accordance with §F(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Department may pay bills received more than 90 days but less than 180 days after the initial physical examination if the Department determines that the provider has set forth a legitimate explanation for not submitting the bill within 90 days of rendering care.</text> </paragraph> <paragraph num="(4)"> <text>To identify the alleged sexual offense, a bill submitted by a provider under this chapter shall contain:</text> <paragraph num="(a)"> <text>A police central complaint number or other case identifier; or</text> </paragraph> <paragraph num="(b)"> <text>A property-held number assigned in accordance with Regulation .03B(1)(b)(ii) of this chapter when there is no police central complaint number or similar police case identifier because a criminal prosecution is not being pursued.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The provider of services shall secure signed informed consent for examination and collection of evidence in cases of alleged rape or sexual offense with authorization for release of information on such forms as are developed by the Department. The providers shall supply the Department with any information requested concerning services rendered.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Payment under this chapter is contingent on the availability of funds according to State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and 15-127, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective July 1, 1978 (5:14 Md. R. 1133), expired November 11, 1978; adopted permanently effective December 15, 1978 (5:25 Md. R. 1854)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 amended effective December 11, 1989 (16:24 Md. R. 2620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B and .04A, E, F amended effective November 14, 1980 (7:23 Md. R. 2166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended and recodified to Regulation .05 and new Regulation .04 adopted effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 5, 2004 (31:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 29, 2008 (35:26 Md. R. 2249)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 29, 2008 (35:26 Md. R. 2249)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, F amended effective December 29, 2008 (35:26 Md. R. 2249)</annotation> </annotations> </chapter> <chapter num="03" heading="Cosmetic Surgical Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Cosmetic Surgical Facility.</text> <paragraph num="(a)"> <text>“Cosmetic surgical facility” means an office or a facility in which a cosmetic surgical procedure is performed.</text> </paragraph> <paragraph num="(b)"> <text>“Cosmetic surgical facility” does not include:</text> <paragraph num="(i)"> <text>An ambulatory surgical facility;</text> </paragraph> <paragraph num="(ii)"> <text>A hospital; or</text> </paragraph> <paragraph num="(iii)"> <text>An office owned or operated by one or more dentists providing services within the scope of practice of dentistry.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cosmetic Surgical Procedure.</text> <paragraph num="(a)"> <text>“Cosmetic surgical procedure” means the use of surgical services to reshape the structure of a human body to change the appearance of an individual.</text> </paragraph> <paragraph num="(b)"> <text>“Cosmetic surgical procedure” does not include:</text> <paragraph num="(i)"> <text>A procedure done under local anesthesia or mild sedation; or</text> </paragraph> <paragraph num="(ii)"> <text>Liposuction that removes less than 1,000 cubic centimeters of aspirate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Facility” means a cosmetic surgical facility as defined in §B(1) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>“Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession.</text> </paragraph> <paragraph num="(6)"> <text>“License” means a document issued by the Secretary to a person to operate a cosmetic surgical facility.</text> </paragraph> <paragraph num="(7)"> <text>“Licensee” means the person to whom a license is issued.</text> </paragraph> <paragraph num="(8)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(9)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License Required."> <paragraph num="A."> <text>A person may not establish or operate a cosmetic surgical facility without obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>License Period and Fee.</text> <paragraph num="(1)"> <text>A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall submit a nonrefundable fee of $3,000 for a 3-year period, with an application for initial licensure, or submit a nonrefundable fee of $3,000 with an application for license renewal for a 3-year period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A license issued under this chapter is not transferable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing Procedures."> <paragraph num="A."> <text>A person desiring to operate a facility shall:</text> <paragraph num="(1)"> <text>Be in compliance with all applicable federal, State, and local laws and regulations and be accredited as a cosmetic surgical facility by:</text> <paragraph num="(a)"> <text>The American Association for Accreditation of Ambulatory Surgical Facilities;</text> </paragraph> <paragraph num="(b)"> <text>The Accreditation Association for Ambulatory Health Care;</text> </paragraph> <paragraph num="(c)"> <text>The Joint Commission; or</text> </paragraph> <paragraph num="(d)"> <text>An accreditation organization approved by the Secretary; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be certified to participate in the Medicare Program, as enacted in Title XVIII of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirement of §A of this regulation, a person desiring to operate a facility shall:</text> <paragraph num="(1)"> <text>File a complete application on a form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Pay the licensure fee set forth in Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to an initial survey upon request by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An officer of a corporation or association shall apply for a license on behalf of the entity. The owner shall apply on behalf of a sole proprietorship. An applicant shall submit the names of the entity's board members, owners, and investors having at least 2 percent ownership.</text> </paragraph> <paragraph num="D."> <text>An authorized individual of a government unit or agency shall apply for a license on behalf of the government unit or agency.</text> </paragraph> <paragraph num="E."> <text>Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall:</text> <paragraph num="(1)"> <text>Approve the application unconditionally if the applicant complies with all requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application conditionally; or</text> </paragraph> <paragraph num="(3)"> <text>Deny the application if the applicant:</text> <paragraph num="(a)"> <text>Has been convicted of:</text> <paragraph num="(i)"> <text>A felony that relates to Medicaid or Medicare; or,</text> </paragraph> <paragraph num="(ii)"> <text>A crime involving moral turpitude; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Does not comply with the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Denial of License for Prior Revocation or Consent to Surrender License. The Secretary may deny a license to:</text> <paragraph num="(1)"> <text>A corporate applicant if the corporate entity has an owner, director, officer, or other person with a substantial interest:</text> <paragraph num="(a)"> <text>Whose conduct caused the revocation of a prior license; or</text> </paragraph> <paragraph num="(b)"> <text>Who held the same or similar position in another corporate entity that had its license revoked;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual applicant:</text> <paragraph num="(a)"> <text>Whose conduct caused the revocation of a prior license; or</text> </paragraph> <paragraph num="(b)"> <text>Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Secretary shall also consider the factors identified in Regulation .10C of this chapter when deciding whether to deny a license.</text> </paragraph> <paragraph num="H."> <text>A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter.</text> </paragraph> <paragraph num="I."> <text>Renewal of License.</text> <paragraph num="(1)"> <text>At least 60 days before a license expires, the licensee shall submit a renewal application to the Secretary.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Temporary License.</text> <paragraph num="(1)"> <text>The Department shall issue a temporary license not to exceed 1 year to a facility that has filed an application to be:</text> <paragraph num="(a)"> <text>Certified to participate in the Medicare Program, as enacted in Title XVIII of the Social Security Act; or</text> </paragraph> <paragraph num="(b)"> <text>Accredited by:</text> <paragraph num="(i)"> <text>The American Association for Accreditation of Ambulatory Surgical Facilities;</text> </paragraph> <paragraph num="(ii)"> <text>The Accreditation Association for Ambulatory Health Care;</text> </paragraph> <paragraph num="(iii)"> <text>The Joint Commission; or</text> </paragraph> <paragraph num="(iv)"> <text>An accreditation organization approved by the Secretary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may extend the period for a temporary license beyond 1 year for good cause.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall issue a license to a facility once the facility has:</text> <paragraph num="(a)"> <text>Received certification or accreditation; and</text> </paragraph> <paragraph num="(b)"> <text>Met all the other requirements for licensure as a cosmetic surgical facility.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department shall void a temporary license upon receiving notice that the facility’s application for certification or accreditation has been denied.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Transfer or Assignment of License Prohibited. If the sale, transfer, assignment, or lease of a cosmetic surgical facility causes a change in the person or persons who control or operate the facility, the Department shall consider the facility to be a new facility and the licensee shall conform to all regulations applicable at the time of transfer of operations.</text> </paragraph> <paragraph num="L."> <text>Return of License. The current license shall become void immediately and the licensee shall return the license to the Secretary if the facility:</text> <paragraph num="(1)"> <text>Is sold or leased;</text> </paragraph> <paragraph num="(2)"> <text>Ceases to operate;</text> </paragraph> <paragraph num="(3)"> <text>Moves to a new permanent location;</text> </paragraph> <paragraph num="(4)"> <text>Has had its Medicare Program certification or accreditation issued by an accreditation organization denied or revoked; or</text> </paragraph> <paragraph num="(5)"> <text>Has its license denied, suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Service Standards."> <paragraph num="A."> <text>The licensee is responsible for compliance with all laws and regulations applicable to the operation of a cosmetic surgical facility including a physician’s compliance with Health Occupations Article, §14-404(a)(41), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Accreditation Standards.</text> <paragraph num="(1)"> <text>The licensee shall meet the standards for the operation of a cosmetic surgical center issued by the licensee’s accreditation organization.</text> </paragraph> <paragraph num="(2)"> <text>If a licensee loses its accreditation, the licensee shall immediately:</text> <paragraph num="(a)"> <text>Cease operations;</text> </paragraph> <paragraph num="(b)"> <text>Notify the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Return the license certificate to the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Investigation by the Secretary."> <paragraph num="A."> <text>The Secretary may investigate complaints concerning the conformance of a cosmetic surgical facility to the requirements of this chapter and for compliance with the standards for the operation of a cosmetic surgical center issued by its accreditation organization.</text> </paragraph> <paragraph num="B."> <text>A facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Secretary to investigate complaints.</text> </paragraph> <paragraph num="C."> <text>The Department shall refer complaints concerning a health care practitioner’s performance or a health care practitioner’s conformance to the standards of medical practice to the appropriate health occupations board that licenses, certifies, or otherwise regulates the health care practitioner under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>Noncompliance.</text> <paragraph num="(1)"> <text>If the Secretary determines that a licensee fails to meet any provision of this chapter or fails to comply with the standards for the operation of a cosmetic surgical center issued by its accreditation organization, the Secretary shall:</text> <paragraph num="(a)"> <text>Advise the licensee of the exact nature of the violation; and</text> </paragraph> <paragraph num="(b)"> <text>Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>This section does not preclude the Secretary from imposing any of the sanctions set forth in this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary may not require that a licensee correct a violation of a standard that is a higher standard than that required of an ambulatory surgical facility under Health-General Article, Title 19, Subtitle 3B, Annotated Code of Maryland, and its implementing regulations.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Records and Reports. The facility shall make its records and reports available to the Department or its designee for inspection during the investigation of a complaint. On the written request of the Department, the facility shall immediately provide photocopies or electronic images of records and reports, including clinical records of patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Medical Records."> <paragraph num="A."> <text>The facility shall maintain a complete, comprehensive, and accurate medical record for a patient.</text> </paragraph> <paragraph num="B."> <text>A patient's medical record shall include at least the following:</text> <paragraph num="(1)"> <text>Patient identifier;</text> </paragraph> <paragraph num="(2)"> <text>Significant medical history and results of a physical examination;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of care or services provided;</text> </paragraph> <paragraph num="(4)"> <text>Evidence of consent; and</text> </paragraph> <paragraph num="(5)"> <text>Discharge diagnosis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The facility shall:</text> <paragraph num="(1)"> <text>Send a copy of the medical record with the patient on referral to another health care provider or on transfer to a hospital;</text> </paragraph> <paragraph num="(2)"> <text>Use the medical record, if appropriate, in instructing the patient and the family; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Patients’ Rights."> <paragraph num="A."> <text>The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities.</text> </paragraph> <paragraph num="B."> <text>The facility shall make the policies and procedures available to patients, guardians, and other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public.</text> </paragraph> <paragraph num="C."> <text>The policies and procedures shall require that:</text> <paragraph num="(1)"> <text>The facility informs patients of services that are available and the charges for services not covered by third-party payors;</text> </paragraph> <paragraph num="(2)"> <text>A physician, dentist, podiatrist, or other qualified health care practitioner informs patients of their medical conditions unless medically contraindicated as documented in their medical records;</text> </paragraph> <paragraph num="(3)"> <text>All patients are afforded an opportunity to participate in planning their medical treatments and to refuse to participate in experimental research; and</text> </paragraph> <paragraph num="(4)"> <text>All patients are ensured confidential treatment of their medical records, and may approve or refuse release of records to any individual outside the facility, except as provided by federal or State law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Physical Environment."> <paragraph num="A."> <text>The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction.</text> </paragraph> <paragraph num="B."> <text>The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06.</text> </paragraph> <paragraph num="C."> <text>The facility shall meet the requirements for the handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the licensee:</text> <paragraph num="(1)"> <text>Informing the licensee of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is immediately suspended, the licensee shall:</text> <paragraph num="(1)"> <text>Immediately return the license certificate to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Stop providing services immediately.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Hearing.</text> <paragraph num="(1)"> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Conduct a hearing as set forth in Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a proposed decision within 10 business days of the close of the hearing record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Final Decision.</text> <paragraph num="(1)"> <text>The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Revocation of License."> <paragraph num="A."> <text>The Secretary, for good cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Secretary may revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Has been convicted of a:</text> <paragraph num="(a)"> <text>Felony that relates to Medicaid or Medicare; or</text> </paragraph> <paragraph num="(b)"> <text>Crime involving moral turpitude;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Does not comply with the requirements of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Fails to comply with the standards for the operation of a cosmetic surgical facility issued by its accreditation organization; or</text> </paragraph> <paragraph num="(4)"> <text>Engages in conduct that requires revocation to protect the public health, safety, or welfare.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall also consider the following factors when deciding whether to revoke a license:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary shall notify the licensee in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the licensee is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the licensee is required to surrender the license to the Department if the revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Penalties."> <paragraph num="A."> <text>Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter.</text> </paragraph> <paragraph num="B."> <text>When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and</text> </paragraph> <paragraph num="(5)"> <text>Such other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, §10-201 et seq., Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, Title 19, Subtitle 3C, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2015 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 30, 2026 (53:6 Md. R. 291)</annotation> </annotations> </chapter> <chapter num="04" heading="Day Care for the Elderly and Adults with a Medical Disability"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to day care centers for the elderly and adults with a medical disability as defined in Health-General Article, Title 14, Subtitles 2 and 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>This chapter does not:</text> <paragraph num="(1)"> <text>Affect a relative, domestic partner, neighbor, or friend who cares for an individual with a medical disability by mutual agreement; or</text> </paragraph> <paragraph num="(2)"> <text>Apply to nutrition sites, senior centers under the auspices of the Department of Aging, or social model programs that individuals may attend to participate in meals or diversion activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities of daily living” means normal daily activities, including:</text> <paragraph num="(a)"> <text>Eating or being fed;</text> </paragraph> <paragraph num="(b)"> <text>Grooming, bathing, and oral hygiene;</text> </paragraph> <paragraph num="(c)"> <text>Mobility, transfer, ambulation, and use of environmental aids to assist the individual to achieve greater independence;</text> </paragraph> <paragraph num="(d)"> <text>Toileting; and</text> </paragraph> <paragraph num="(e)"> <text>Dressing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Activities coordinator” means the individual assigned to develop and direct the activity program for the adult day care center.</text> </paragraph> <paragraph num="(3)"> <text>“Actual harm deficiency” means:</text> <paragraph num="(a)"> <text>A condition existing in a center; or</text> </paragraph> <paragraph num="(b)"> <text>An action or inaction by the center staff that has caused physical or emotional injury or impairment to a participant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Adult Day Care Assessment and Planning System (ADCAPS)” means a system that is comprised of a comprehensive assessment completed by the RN, that is designed to evaluate the participant’s strengths and needs, which facilitates the development of a problem list, service plans, and personal goals that make up the individualized plan of care.</text> </paragraph> <paragraph num="(5)"> <text>"Center" means any nonresidential program meeting the definition in Health-General Article, §14-201(b) or 14-301(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Certified medication technician (CMT)” means an individual who is certified as a medication technician as defined in Health Occupations Article, §8-6A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Certified Nursing Assistant (CNA)” means an individual who is certified as a nursing assistant as defined in Health Occupations Article, §8-6A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Chemical restraint” means the use of a drug or medication that is not a standard treatment for a participant's condition to control or restrict the participant's movement</text> </paragraph> <paragraph num="(9)"> <text>“Cognitively intact” means a participant who has sufficient judgment, planning, organization, self-control, and the persistence needed to manage the normal demands of the participant's environment.</text> </paragraph> <paragraph num="(10)"> <text>“Communicable disease” has the meaning stated in COMAR 10.06.01.02 and 10.06.01.03.</text> </paragraph> <paragraph num="(11)"> <text>“Deficiency” means a condition existing in a center, or an action or inaction by the center staff that result in the potential for more than minimal harm, actual harm, or serious and immediate threat to one or more participants.</text> </paragraph> <paragraph num="(12)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(13)"> <text>“Direct participant care” means day-to-day direct assistance to participants in accomplishing activities of daily living and in meeting health and psychosocial needs.</text> </paragraph> <paragraph num="(14)"> <text>“Employee” means a full-time or part-time staff individual who works regular hours for pay.</text> </paragraph> <paragraph num="(15)"> <text>“Existing center” means a center that is licensed by the Department or has its plans approved by the Department at the time of adoption of the regulations of this chapter.</text> </paragraph> <paragraph num="(16)"> <text>“Full-time” means 40 hours per week or the standard workweek adopted by the center.</text> </paragraph> <paragraph num="(17)"> <text>“Governing body” means the individual, partnership, agency, group, corporation, or other entity set up to assume full legal responsibility for the policy determination, management, operation, and financial liability of the center.</text> </paragraph> <paragraph num="(18)"> <text>“Individual plan (IP)” means a document that specifies assessments, services, supports, and training required by the individual as specified in COMAR 10.22.05.</text> </paragraph> <paragraph num="(19)"> <text>“Informal Dispute Resolution (IDR)” means an informal process that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection.</text> </paragraph> <paragraph num="(20)"> <text>"Health care provider” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care services.</text> </paragraph> <paragraph num="(21)"> <text>“Licensed practical nurse (LPN)” means an individual:</text> <paragraph num="(a)"> <text>Licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Whose practice is in accordance with the provisions of COMAR 10.27.10.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Licensed social worker” means an individual who is licensed to practice social work as defined in Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Mental illness” has the meaning stated in COMAR 10.09.70.10A.</text> </paragraph> <paragraph num="(24)"> <text>“New center” means a center that does not have plans approved by the Department.</text> </paragraph> <paragraph num="(25)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(26)"> <text>“Ongoing pattern” means the occurrence of any potential for more than minimal harm or greater deficiency on two consecutive on-site visits as a result of annual surveys, follow up visits, any unscheduled visits, or complaint investigations.</text> </paragraph> <paragraph num="(27)"> <text>“Participant” means a health-impaired adult whose:</text> <paragraph num="(a)"> <text>Illness or disability does not require 24-hour inpatient care; and</text> </paragraph> <paragraph num="(b)"> <text>Needs cannot be satisfactorily met in an episodic ambulatory care setting but require at least 1 day of care per week in a day care program.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Part-time” means less than full-time.</text> </paragraph> <paragraph num="(29)"> <text>“Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body or limb movement, that cannot be readily and easily removed by the participant knowingly and with intent.</text> </paragraph> <paragraph num="(30)"> <text>“Physician” means an individual licensed to practice medicine as defined in Health Occupations Article, §14-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“Potential for more than minimal harm deficiency” means a condition existing in a center or an action or inaction by the center staff that has the potential to cause actual harm to the participant.</text> </paragraph> <paragraph num="(32)"> <text>“Pre-licensure site visit” means an on-site survey to determine if a center is ready to begin operating in accordance with the requirements set forth in this chapter.</text> </paragraph> <paragraph num="(33)"> <text>“Problem list” means issues and concerns identified from the assessment.</text> </paragraph> <paragraph num="(34)"> <text>“Program assistant” means an individual assigned to perform activities, supportive functions, and direct participant care under appropriate supervision.</text> </paragraph> <paragraph num="(35)"> <text>“Registered nurse (RN)” means an individual licensed to practice as a registered nurse as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(36)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(37)"> <text>“Self-administer” means the act of a participant taking medication at the correct time, by the correct route, and in the correct dosage, as prescribed by an authorized prescriber.</text> </paragraph> <paragraph num="(38)"> <text>“Serious and immediate threat” means a situation in which immediate corrective action is necessary because a center's noncompliance with one or more State regulations has caused, or is likely to cause, serious injury, harm, impairment to, or death of a participant receiving care in the center.</text> </paragraph> <paragraph num="(39)"> <text>“Significant change of condition” means a change in the participant’s physical, mental, or psychological status as defined by the registered nurses comprehensive assessment.</text> </paragraph> <paragraph num="(40)"> <text>“Sustained compliance” means a period of 30 days following the date of notice of corrective action with no deficiencies.</text> </paragraph> <paragraph num="(41)"> <text>“Volunteer” means an individual who:</text> <paragraph num="(a)"> <text>Gives help, does a service, or takes an obligation, on-site for 8 hours or more per week, without payment; and</text> </paragraph> <paragraph num="(b)"> <text>Serves or acts of his or her own free will under the direction of the administrative staff of the center.</text> </paragraph> </paragraph> <paragraph num="(42)"> <text>“Written agreement” means a legally binding contract between two or more parties that sets forth terms and conditions and which has been reduced to writing and signed and dated by all parties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>A person may not establish, operate, or continue the operation of a center without first obtaining a license from the Secretary.</text> </paragraph> <paragraph num="B."> <text>Separate License Required. Separate licenses are required for centers that are maintained on separate premises, even though the centers are operated under the same management.</text> </paragraph> <paragraph num="C."> <text>Posting of License. A center shall post its license in a conspicuous place on the premises to which it applies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensing Procedure."> <paragraph num="A."> <text>Letter of Interest.</text> <paragraph num="(1)"> <text>A person desiring to obtain initial licensure for an adult day care center shall submit a letter of interest to the Office of Health Care Quality that contains the following:</text> <paragraph num="(a)"> <text>Policies and procedures that address medical record completion and retention, the administration and storage of medications, nutrition services, social work support, employee criminal background checks, transportation of participants and participant activities;</text> </paragraph> <paragraph num="(b)"> <text>Identification of the individual or individuals or business entity that will own and operate the adult medical day care program;</text> </paragraph> <paragraph num="(c)"> <text>The job description and qualifications for each position;</text> </paragraph> <paragraph num="(d)"> <text>The projected hours of operation, daily census, and the staffing plan that addresses both licensed and non-licensed staff coverage; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the structural design plans for the proposed adult medical day care program have been forwarded to the Department’s Plans Review and Approval Unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An application for licensure may not be accepted by the Department until the information submitted in the letter of interest is reviewed and approved.</text> </paragraph> <paragraph num="(3)"> <text>A letter of interest is not required for licensees seeking renewal.</text> </paragraph> <paragraph num="(4)"> <text>Upon approval of the letter of interest, an application for licensure shall be submitted on the form developed by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Investigation of Application. The Department's authorized representative shall interview the prospective licensee and inspect the proposed center.</text> </paragraph> <paragraph num="C."> <text>Issuance of License. When the Department determines that the center has submitted a complete application, and that the center is in compliance with this chapter, the Department shall issue a license to operate the center.</text> </paragraph> <paragraph num="D."> <text>Conditions and Limitations of License. The following conditions and limitations apply to a center's license:</text> <paragraph num="(1)"> <text>A license shall be issued for a 2-year period,</text> </paragraph> <paragraph num="(2)"> <text>The Department may perform a periodic re-inspection of the center at any time;</text> </paragraph> <paragraph num="(3)"> <text>A license may not be transferable or assignable from place to place or from one person to another;</text> </paragraph> <paragraph num="(4)"> <text>The licensee shall notify the Department of any change of ownership, and the new owner shall apply to the Department for a license; and</text> </paragraph> <paragraph num="(5)"> <text>The number of participants cared for at any one time in a center may not exceed the licensed capacity of the center.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Return of License. The current license shall become void immediately and the licensee shall return the license to the Secretary if the center:</text> <paragraph num="(1)"> <text>Is sold or leased;</text> </paragraph> <paragraph num="(2)"> <text>Ceases to operate for more than 30 consecutive days;</text> </paragraph> <paragraph num="(3)"> <text>Moves to a new permanent location;</text> </paragraph> <paragraph num="(4)"> <text>Has its license denied, suspended or revoked; or</text> </paragraph> <paragraph num="(5)"> <text>Changes its Ownership</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Changes in a Program that Affect the Operating License."> <paragraph num="A."> <text>Increase in Capacity or Name Change.</text> <paragraph num="(1)"> <text>During the license period, a licensee may not increase capacity, change its name, or change the name under which the program is doing business without the Department's approval. When there is a change of program ownership or a change of location, the licensee shall submit a new application and written request for a new license with an application fee, as established in Regulation .04A(2) of this chapter to the Department.</text> </paragraph> <paragraph num="(2)"> <text>Sale, Transfer, or Lease of a Center.</text> <paragraph num="(a)"> <text>If a sale, lease or any other transaction causes a change in the individual or individuals who control or operate the center, the center shall be considered a new program and the new owner-operator shall apply for a new license and conform to all regulations applicable at the time of transfer of operations.</text> </paragraph> <paragraph num="(b)"> <text>The transfer of any stock which results in a change of the individual or individuals who control the program or the transfer of any stock in excess of 25 percent of the outstanding stock constitutes a sale.</text> </paragraph> <paragraph num="(c)"> <text>For the purposes of Life Safety Code enforcement, the program is considered an existing center if it has been in continuous use as an adult medical day program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall issue a new license on approval of:</text> <paragraph num="(a)"> <text>A change in licensure capacity;</text> </paragraph> <paragraph num="(b)"> <text>A change in the name of the licensee; or</text> </paragraph> <paragraph num="(c)"> <text>A change in the name under which the program is doing business.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The licensee shall return its original license to the Department by certified mail.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Voluntary Closure or Change of an Adult Medical Day Program Ownership or Location.</text> <paragraph num="(1)"> <text>A licensee shall notify the Department in writing at least 45 days in advance of any intention to:</text> <paragraph num="(a)"> <text>Voluntarily close;</text> </paragraph> <paragraph num="(b)"> <text>Change ownership;</text> </paragraph> <paragraph num="(c)"> <text>Change location; or</text> </paragraph> <paragraph num="(d)"> <text>Sell its adult medical day program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee shall include the following information in the notice to the Department:</text> <paragraph num="(a)"> <text>The method for informing participants and participant representatives of its intent to close, change ownership, change location, or sell its center; and</text> </paragraph> <paragraph num="(b)"> <text>The actions the licensee will take to assist participants in securing comparable day services and assistance, if necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee shall notify participants and participant representatives of any proposed changes set forth in §B(1) of this regulation, in writing, at least 45 days before the effective date of the proposed change.</text> </paragraph> <paragraph num="(4)"> <text>Whenever ownership of a center is changed from the individual or organization named on the license to another individual or organization, the future owner shall apply for a new license. The future owner shall file an application for a license at least 45 days before the final transfer.</text> </paragraph> <paragraph num="(5)"> <text>The Department shall issue a new license to a new owner if the new owner meets the requirements for licensure under this chapter. The current licensee shall return its license to the Department by certified mail.</text> </paragraph> <paragraph num="(6)"> <text>A licensee named in the original license shall remain responsible for the operation of the center until a new license is issued to the new owner and the current licensee shall remain responsible for correction of all outstanding deficiencies or impending sanctions until a new license is issued to the new owner.</text> </paragraph> <paragraph num="(7)"> <text>If a licensee intends to relocate its program, the licensee shall apply for a new license in time to assure continuity of services to the participants. The Secretary shall issue a new license for the new location if the program meets the requirements for licensure under this chapter. The licensee shall return its original license to the Department by certified mail.</text> </paragraph> <paragraph num="(8)"> <text>After a program closes, in addition to the notice to the Department required by §B of this regulation, the licensee shall:</text> <paragraph num="(a)"> <text>Notify the Department of the date of closure and the place of relocation of each participant; and</text> </paragraph> <paragraph num="(b)"> <text>Return all licenses, past and present, to the Department by certified mail.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Changes to Licensure Information.</text> <paragraph num="(1)"> <text>A licensee shall immediately notify the Department of any changes that occur in the licensee's operations that were not submitted with the most recent application.</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall forward to the Department a copy of any report or citation of a violation that affects the health, safety, or welfare of participants, including building codes, sanitary codes, fire safety codes, or other regulations, that remains uncorrected or unresolved within 7 days of receiving the report or citation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>License — Sale, Assignment, or Other Transfer.</text> <paragraph num="(1)"> <text>A license is valid only in the name of the person to whom it is issued and is not subject to sale, assignment, or other transfer.</text> </paragraph> <paragraph num="(2)"> <text>A license is valid only for the premises for which it was originally issued.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Waiver of Provisions."> <paragraph num="A."> <text>The Secretary may waive any provision of this chapter if a center:</text> <paragraph num="(1)"> <text>Experiences practical difficulties or unnecessary hardship in complying with the provisions of this chapter: and</text> </paragraph> <paragraph num="(2)"> <text>Can demonstrate that granting a waiver will not adversely affect the health and safety of its participants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee shall submit a written request to the Department to obtain a waiver. In the written request, the licensee shall address the following issues:</text> <paragraph num="(1)"> <text>The regulation from which a waiver is sought;</text> </paragraph> <paragraph num="(2)"> <text>The reason the licensee is unable to comply with the regulation;</text> </paragraph> <paragraph num="(3)"> <text>The reason that compliance with the regulation will impose a substantial hardship; and</text> </paragraph> <paragraph num="(4)"> <text>The reason that a waiver will not adversely affect participants care or services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall provide written approval of any waiver granted to a center, and the approval letter shall specify the effective time frame for the waiver.</text> </paragraph> <paragraph num="D."> <text>The Department shall review each waiver during the license renewal process.</text> </paragraph> <paragraph num="E."> <text>The Secretary may revoke a waiver at any time if:</text> <paragraph num="(1)"> <text>A center violates any condition of the waiver; or</text> </paragraph> <paragraph num="(2)"> <text>It appears to the Secretary that the health or safety of participants attending the center will be adversely affected by the continuation of the waiver.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The revocation of a waiver may not be appealed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspection by the Department."> <paragraph num="A."> <text>Center Open for Inspection.</text> <paragraph num="(1)"> <text>A licensed center and any premises proposed to be operated as a center shall be open at all reasonable times to announced or unannounced inspections by the Department and by any agency designated by the Department.</text> </paragraph> <paragraph num="(2)"> <text>Any part of the center, and any surrounding accessory buildings, are considered part of the center and are subject to inspection.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Records and Reports.</text> <paragraph num="(1)"> <text>A licensee shall maintain records and make reports as required by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The records and reports shall be open to inspection by the Department or any agency designated by the Department.</text> </paragraph> <paragraph num="(3)"> <text>On request, a licensee shall immediately provide copies of records and reports, policies and procedures, including medical records of current participants, participants discharged within the last 6 months, personnel records of current staff, and those records and reports relating to quality assurance activities to the Department or any agency designated by the Department.</text> </paragraph> <paragraph num="(4)"> <text>All other records and reports may be stored off-site, but shall be available to the Department within 24 hours of request.</text> </paragraph> <paragraph num="(5)"> <text>If requested, the Department shall reimburse the licensee for the reasonable costs of copying the records and reports.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Compliance Monitoring."> <paragraph num="A."> <text>The Department shall monitor or inspect a center at least once every 2 years to ensure compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department may conduct unannounced or announced licensure or complaint investigation visits as frequently as necessary to ensure compliance with this chapter or for the purpose of investigating a complaint.</text> </paragraph> <paragraph num="C."> <text>In accordance with a written agreement, the Department may delegate certain aspects of its monitoring or inspection responsibilities to a local health department.</text> </paragraph> <paragraph num="D."> <text>Notice of Violations. If a complaint investigation or survey inspection identifies a regulatory violation, the Department shall issue a notice:</text> <paragraph num="(1)"> <text>Citing the violation;</text> </paragraph> <paragraph num="(2)"> <text>Requiring the center to submit an acceptable plan of correction within 10 calendar days of receipt of the notice of violation or deficiency;</text> </paragraph> <paragraph num="(3)"> <text>Notifying the center of sanctions or that failure to correct the violation may result in sanctions; and</text> </paragraph> <paragraph num="(4)"> <text>Offering the center the opportunity for informal dispute resolution (IDR).</text> </paragraph> </paragraph> <paragraph num="E."> <text>The plan of correction referred to in §D(2) of this regulation shall include the date by which the licensee shall complete the correction of each deficiency. Failure to return an acceptable plan of correction within the allotted time frame may result in a sanction.</text> </paragraph> <paragraph num="F."> <text>When a licensee requests an IDR as provided in §G of this regulation, the licensee shall file a plan of correction within the required time, except to the extent that the licensee contests specific findings, in which case absent the Department's specific directive, a licensee may delay submitting its plan of correction with respect to those specific findings until 5 days after the licensee is provided oral or written notice of the outcome of the IDR.</text> </paragraph> <paragraph num="G."> <text>Informal Dispute Resolution.</text> <paragraph num="(1)"> <text>A licensee may request an IDR to question violations or deficiencies within 10 calendar days of receiving the statement of deficiencies. The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by any supporting documentation.</text> </paragraph> <paragraph num="(2)"> <text>At the discretion of the Office of Health Care Quality, the IDR may be held in-person, by telephone, or in writing. In-person IDRs are informal in nature and are not attended by counsel.</text> </paragraph> <paragraph num="(3)"> <text>The IDR process may not delay the effective date of any enforcement action.</text> </paragraph> <paragraph num="(4)"> <text>In the event a licensee requests an IDR of a violation written by a designee of the Department, the Department shall request the designee to participate in the IDR process.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Administration."> <paragraph num="A."> <text>Governing Body. The governing body shall establish and maintain sound operating procedures, including:</text> <paragraph num="(1)"> <text>Maintenance of an identifiable administrative unit, headed by a director who is responsible for the overall conduct of all center activities;</text> </paragraph> <paragraph num="(2)"> <text>Adoption of an annual budget; and</text> </paragraph> <paragraph num="(3)"> <text>Provision of staff capable of performing the center's program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Goals. The center shall have documentation of its philosophy and goals and the services to be provided. The services to be provided by the center shall be reflective of the populations served.</text> </paragraph> <paragraph num="C."> <text>Policies and Procedures. The governing body shall establish policies and procedures for the center, including:</text> <paragraph num="(1)"> <text>Admissions;</text> </paragraph> <paragraph num="(2)"> <text>Discharges;</text> </paragraph> <paragraph num="(3)"> <text>Fees;</text> </paragraph> <paragraph num="(4)"> <text>Health care;</text> </paragraph> <paragraph num="(5)"> <text>Hours of operation;</text> </paragraph> <paragraph num="(6)"> <text>Personnel;</text> </paragraph> <paragraph num="(7)"> <text>Plans for emergencies, disasters, and epidemics;</text> </paragraph> <paragraph num="(8)"> <text>Use of consultants;</text> </paragraph> <paragraph num="(9)"> <text>Relationships with other agencies and care providers;</text> </paragraph> <paragraph num="(10)"> <text>Documentation and accounting procedures for medications released into the community;</text> </paragraph> <paragraph num="(11)"> <text>Quality assurance; and</text> </paragraph> <paragraph num="(12)"> <text>Other policies as necessary</text> </paragraph> </paragraph> <paragraph num="D."> <text>The center shall provide OHCQ a contact phone number, providing direct access to the center or center’s representative that shall be available 24 hours a day, 7 days a week.</text> </paragraph> <paragraph num="E."> <text>The governing body shall review all policies annually and make revisions as necessary. A Registered Nurse shall assist in the review process and in developing health policies and providing other services as indicated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Days and Hours of Operation."> <paragraph num="A."> <text>The center shall be open to participants for at least 6 hours per day 5 days a week, exclusive of holidays and other planned closings.</text> </paragraph> <paragraph num="B."> <text>The center's hours of operation shall be posted in a prominent place accessible to and easily seen by participants.</text> </paragraph> <paragraph num="C."> <text>The public and participants shall be notified of planned closings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Preadmission Assessment."> <paragraph num="A."> <text>Before admission, the center shall obtain a written assessment from the prospective participant's health care provider, who shall certify that the information provided reflects the individual's health status within 45 days of the individual's admission. Upon request and for good cause shown, the Department may grant an exception to all or part of the preadmission assessment.</text> </paragraph> <paragraph num="B."> <text>Written Assessment. The health care provider's assessment shall include:</text> <paragraph num="(1)"> <text>Recent medical history, including any acute medical condition or hospitalization;</text> </paragraph> <paragraph num="(2)"> <text>Significant medical conditions affecting function, including the individual's ability for self-care, cognition, physical conditions, and behavioral and psychosocial status;</text> </paragraph> <paragraph num="(3)"> <text>Other active and significant chronic or acute medical diagnoses;</text> </paragraph> <paragraph num="(4)"> <text>Known allergies to medications, environment, and food;</text> </paragraph> <paragraph num="(5)"> <text>Medical confirmation that the individual is free from communicable disease and other active reportable airborne diseases;</text> </paragraph> <paragraph num="(6)"> <text>Current and other needed medications and treatments and the ability of the individual to self-medicate or self-treat;</text> </paragraph> <paragraph num="(7)"> <text>Information of advanced directives for health care;</text> </paragraph> <paragraph num="(8)"> <text>Current nutritional status including height, weight, risk factors, and deficits;</text> </paragraph> <paragraph num="(9)"> <text>Diets ordered by the health care provider;</text> </paragraph> <paragraph num="(10)"> <text>Medically necessary limitations or precautions; and</text> </paragraph> <paragraph num="(11)"> <text>Monitoring or performance of tests after admission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Admission Criteria."> <paragraph num="A."> <text>The center shall develop written criteria for admission. These criteria shall be specific so that the center does not accept individuals whose needs cannot be met by the center.</text> </paragraph> <paragraph num="B."> <text>Admission Criteria. The admission criteria shall include at least the following:</text> <paragraph num="(1)"> <text>The center may not discriminate against the intended participant because of race, color, or national origin according to Title VI of the Civil Rights Act of 1964, 42 U.S.C. §2000 or as otherwise provided by law;</text> </paragraph> <paragraph num="(2)"> <text>The center may not deny admission to or involuntarily discharge an individual solely because the individual has a communicable disease.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The center shall provide the participant and his or her responsible party a written service contract.</text> </paragraph> <paragraph num="D."> <text>The service contract shall be signed by both the center’s representative and the participant or his or her responsible party.</text> </paragraph> <paragraph num="E."> <text>The service contract shall specify:</text> <paragraph num="(1)"> <text>Number of days per week and type of services that are to be provided to the participant;</text> </paragraph> <paragraph num="(2)"> <text>Process by which goals are developed for the participant;</text> </paragraph> <paragraph num="(3)"> <text>Conditions under which the participant may be discharged; and</text> </paragraph> <paragraph num="(4)"> <text>Consent agreements as required for:</text> <paragraph num="(a)"> <text>Transportation;</text> </paragraph> <paragraph num="(b)"> <text>Treatment;</text> </paragraph> <paragraph num="(c)"> <text>Medication administration;</text> </paragraph> <paragraph num="(d)"> <text>Off-site activities;</text> </paragraph> <paragraph num="(e)"> <text>Photographs for promotional use; and</text> </paragraph> <paragraph num="(f)"> <text>Release of medical information.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Participant Rights."> <paragraph num="A."> <text>The adult day care center shall provide care for participants in a manner and in an environment that maintains or enhances each participant’s dignity and respect.</text> </paragraph> <paragraph num="B."> <text>The center shall inform the participant, in a language that the participant understands, of his or her rights and all rules and regulations governing participant conduct and responsibilities while attending the program.</text> </paragraph> <paragraph num="C."> <text>A participant of a center has the right to:</text> <paragraph num="(1)"> <text>Be treated with consideration, respect, and full recognition of the participant's human dignity and individuality;</text> </paragraph> <paragraph num="(2)"> <text>Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;</text> </paragraph> <paragraph num="(3)"> <text>Privacy;</text> </paragraph> <paragraph num="(4)"> <text>Be free from mental, verbal, sexual, and physical abuse and neglect, involuntary seclusion, and exploitation;</text> </paragraph> <paragraph num="(5)"> <text>Be free from physical and chemical restraints except as permitted in Regulation .23 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Confidentiality;</text> </paragraph> <paragraph num="(7)"> <text>Make suggestions, complaints, or present grievances on behalf of the participants or others, to the center director, government agencies, or other individuals without threat or fear of retaliation;</text> </paragraph> <paragraph num="(8)"> <text>Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the participant may have;</text> </paragraph> <paragraph num="(9)"> <text>Have access to the procedures for making complaints to the:</text> <paragraph num="(a)"> <text>Local department of social services; and</text> </paragraph> <paragraph num="(b)"> <text>Office of Health Care Quality of the Department;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Participate in care planning and medical treatment; and</text> </paragraph> <paragraph num="(11)"> <text>Refuse treatment after the possible consequences of refusing treatment is fully explained.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Staff."> <paragraph num="A."> <text>Staffing Pattern.</text> <paragraph num="(1)"> <text>Staffing Ratio.</text> <paragraph num="(a)"> <text>The staff to participant ratio at each center shall be a minimum of one staff to seven participants (1:7) for a period of 2 years after the final adoption of COMAR 10.12.04.14A(1)(a).</text> </paragraph> <paragraph num="(b)"> <text>Two years after the final adoption of COMAR 10.12.04.14A(1)(a), the staffing ratio at each center shall be determined by the needs of each program participant as determined in the ADCAPS.</text> </paragraph> <paragraph num="(c)"> <text>Staffing shall at all times be sufficient to meet the needs of the participants.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The center shall have experienced and competent relief personnel, with licenses and levels of skill comparable to regular staff, to operate during absences, vacations, or other periods necessitating substitute staff.</text> </paragraph> <paragraph num="(3)"> <text>Relief personnel shall be oriented to the operation of the center.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Required Staff.</text> <paragraph num="(1)"> <text>Director.</text> <paragraph num="(a)"> <text>The center shall have a director who is responsible for the overall conduct of the center and for compliance with applicable laws and regulations.</text> </paragraph> <paragraph num="(b)"> <text>The director shall have a bachelor's degree, preferably in a health and human services field, from an accredited college or university, or the individual shall be a registered nurse.</text> </paragraph> <paragraph num="(c)"> <text>The director's duties shall be limited to the administration and provision of services at the center.</text> </paragraph> <paragraph num="(d)"> <text>If a center is part of another center, the center shall have its own director and center staff.</text> </paragraph> <paragraph num="(e)"> <text>A center with a licensed capacity of 35 or more participants shall have a full-time director.</text> </paragraph> <paragraph num="(f)"> <text>A center with a licensed capacity of 34 or fewer participants may appoint a director who serves on less than a full-time basis.</text> </paragraph> <paragraph num="(g)"> <text>A licensee operating two adult medical day care sites that are located within 50 miles of each other may utilize one on-site manager instead of a director at one of the sites if there are fewer than 50 participants at each site. The on-site manager shall have the appropriate background, education, and experience to oversee the administration and provision of services at the center.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Nursing Services.</text> <paragraph num="(a)"> <text>A center shall have the services of a registered nurse with at least 3 years experience in a health care setting.</text> </paragraph> <paragraph num="(b)"> <text>A registered nurse shall be on-site or readily available by phone at other times to satisfy the requirements listed in §B(2)(c) of this regulation.</text> </paragraph> <paragraph num="(c)"> <text>The duties of the registered nurse shall include:</text> <paragraph num="(i)"> <text>Completion of the ADCAPS and the nursing plan of care.</text> </paragraph> <paragraph num="(ii)"> <text>Provision or supervision, or both, of required nursing services to each participant;</text> </paragraph> <paragraph num="(iii)"> <text>Supervision of the LPN and other nursing care staff in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11.05H(1);</text> </paragraph> <paragraph num="(iv)"> <text>Development and ongoing review of the participant's plan of care; and</text> </paragraph> <paragraph num="(v)"> <text>Assisting, as necessary, in the delivery of other required services.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A licensed practical nurse performs in a team relationship with the registered nurse and shall be on site to meet the nursing services of each participant consistent with COMAR 10.27.10 when the registered nurse is not on site.</text> </paragraph> <paragraph num="(e)"> <text>A certified nursing assistant shall be present and on site when a registered nurse or licensed practical nurse is not on site.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Full-time Activities Coordinator. The center shall have the services of a full-time activities coordinator who shall have:</text> <paragraph num="(a)"> <text>A high school diploma or general equivalency diploma (GED); and</text> </paragraph> <paragraph num="(b)"> <text>At least 3 years experience in activities coordination or therapeutic recreation for:</text> <paragraph num="(i)"> <text>The aged;</text> </paragraph> <paragraph num="(ii)"> <text>Individuals with disabilities; or</text> </paragraph> <paragraph num="(iii)"> <text>Other special populations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Staff.</text> <paragraph num="(a)"> <text>Program assistants shall:</text> <paragraph num="(i)"> <text>Have a high school diploma or general equivalency diploma (GED); or</text> </paragraph> <paragraph num="(ii)"> <text>Be enrolled currently in a program leading to a high school diploma or GED.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The center shall employ sufficient staff to meet the participants' needs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Personnel Policies.</text> <paragraph num="(1)"> <text>The center shall have written personnel policies, including at least the following:</text> <paragraph num="(a)"> <text>Annual leave;</text> </paragraph> <paragraph num="(b)"> <text>Pay practices;</text> </paragraph> <paragraph num="(c)"> <text>Employee benefits;</text> </paragraph> <paragraph num="(d)"> <text>Termination procedures;</text> </paragraph> <paragraph num="(e)"> <text>Hiring and firing responsibility;</text> </paragraph> <paragraph num="(f)"> <text>Review of applicant and employee criminal conviction histories;</text> </paragraph> <paragraph num="(g)"> <text>New employee orientation; and</text> </paragraph> <paragraph num="(h)"> <text>Use and duration of a probationary period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The center shall make a copy of its policies and procedures available to each employee.</text> </paragraph> <paragraph num="(3)"> <text>Before hiring, staff:</text> <paragraph num="(a)"> <text>Shall have a criminal background check as required in Health-General Article, §19-1901, et seq., Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>May not have criminal convictions or criminal history that indicates behavior that is potentially harmful to participants, as evidenced through a criminal history records check.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Position Description. There shall be a written position description for each job that specifies:</text> <paragraph num="(1)"> <text>The qualifications for the job;</text> </paragraph> <paragraph num="(2)"> <text>A delineation of the tasks; and</text> </paragraph> <paragraph num="(3)"> <text>The supervisor of the employee.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Staff Training.</text> <paragraph num="(1)"> <text>When job duties involve the provision of individual care services, employees shall receive a minimum of 2 hours of training on cognitive impairment and mental illness within the first 90 days of employment, including the following as appropriate:</text> <paragraph num="(a)"> <text>Overview of normal aging and conditions causing cognitive impairment;</text> <paragraph num="(i)"> <text>Risk factors for cognitive impairment;</text> </paragraph> <paragraph num="(ii)"> <text>Health conditions that affect cognitive impairment; and</text> </paragraph> <paragraph num="(iii)"> <text>Early identification of and intervention for cognitive impairment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Overview of normal aging and conditions causing mental illness;</text> <paragraph num="(i)"> <text>Risk factors for mental illness;</text> </paragraph> <paragraph num="(ii)"> <text>Health conditions that affect mental illness;</text> </paragraph> <paragraph num="(iii)"> <text>Early identification of and intervention for mental illness; and</text> </paragraph> <paragraph num="(iv)"> <text>Procedures for reporting cognitive, behavioral, and mood changes;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Effective communication including:</text> <paragraph num="(i)"> <text>The effect of cognitive impairment on expressive and receptive communication;</text> </paragraph> <paragraph num="(ii)"> <text>The effect of mental illness on expressive and receptive communication;</text> </paragraph> <paragraph num="(iii)"> <text>Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and</text> </paragraph> <paragraph num="(iv)"> <text>Environmental stimuli and influences on communication; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Behavioral intervention, including:</text> <paragraph num="(i)"> <text>Identifying and interpreting behavioral symptoms;</text> </paragraph> <paragraph num="(ii)"> <text>Problem solving for appropriate intervention;</text> </paragraph> <paragraph num="(iii)"> <text>Risk factors and safety precautions to protect the individual and other participants; and</text> </paragraph> <paragraph num="(iv)"> <text>De-escalation techniques.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The director shall ensure that:</text> <paragraph num="(a)"> <text>Per the center’s policies, staff and volunteers receive orientation and training; and</text> </paragraph> <paragraph num="(b)"> <text>An ongoing educational program is planned and conducted for the development and improvement of skills of all the center's personnel, including training related to problems and needs of the elderly, health impaired, and disabled.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The center shall maintain records that demonstrate proof of employee attendance and training content of orientation and in-service programs.</text> </paragraph> <paragraph num="(4)"> <text>The center shall provide a minimum of eight in-service training sessions annually, which shall include, but is not limited to:</text> <paragraph num="(a)"> <text>Prevention and control of infections;</text> </paragraph> <paragraph num="(b)"> <text>Fire prevention programs and participant-related safety procedures in emergency situations or conditions;</text> </paragraph> <paragraph num="(c)"> <text>Accident prevention;</text> </paragraph> <paragraph num="(d)"> <text>Training on care of individuals that is appropriate to the population served by the center, such as:</text> <paragraph num="(i)"> <text>Alzheimer's disease;</text> </paragraph> <paragraph num="(ii)"> <text>Mental illness;</text> </paragraph> <paragraph num="(iii)"> <text>Developmental disabilities; and</text> </paragraph> <paragraph num="(iv)"> <text>Cognitive impairment;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Recognition of, and duty to report, abuse, exploitation, neglect, and self-neglect; and</text> </paragraph> <paragraph num="(f)"> <text>Safe food handling and service.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The training that is described in §F of this regulation may be provided through various means including:</text> <paragraph num="(a)"> <text>Classroom instruction;</text> </paragraph> <paragraph num="(b)"> <text>In-service training;</text> </paragraph> <paragraph num="(c)"> <text>Internet courses;</text> </paragraph> <paragraph num="(d)"> <text>Correspondence courses;</text> </paragraph> <paragraph num="(e)"> <text>Prerecorded training; or</text> </paragraph> <paragraph num="(f)"> <text>Other training methods.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>When the training method does not involve direct interaction between faculty and trainee, the center shall make available to the trainee a trained individual to answer questions and respond to issues raised by the training.</text> </paragraph> <paragraph num="G."> <text>Proof of training shall include:</text> <paragraph num="(1)"> <text>Date of class;</text> </paragraph> <paragraph num="(2)"> <text>Course content;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of successful completion of the training content; and</text> </paragraph> <paragraph num="(4)"> <text>Qualifications and contact information for the trainer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Program Components — Required Services."> <paragraph num="A."> <text>Health Services.</text> <paragraph num="(1)"> <text>Nursing Services. The center shall provide nursing services under the direction of a registered nurse. The licensee shall fully disclose the services that will be provided outside the adult medical day care center’s hours of operation, in the service contract agreement. The registered nurse may delegate nursing services as appropriate, to other staff in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11.05H(1)—(3).</text> </paragraph> <paragraph num="(2)"> <text>Consultation with the Health Care Provider. The RN or LPN nurse shall communicate with the participant's health care provider to report observed changes in the participant's health status, including reaction to medicine, and to obtain current medical orders regarding such items as diet, medications, and treatments. The center shall assist participants in locating a regular source of health care if a participant does not have a health care provider.</text> </paragraph> <paragraph num="(3)"> <text>Mental Health Services. For participants with mental health needs, the program shall provide, when needed, linkage, collaboration, and coordination with the participant's treating psychiatrist or other mental health professional.</text> </paragraph> <paragraph num="(4)"> <text>Observation. The registered nurse or the licensed practical nurse shall observe the health, functional status, and adherence to a prescribed medical regimen, and document his or her observations in the participant's medical record at least monthly.</text> </paragraph> <paragraph num="(5)"> <text>The center shall provide meals and snacks to participants in accordance with Regulation .20 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Services and Medical Plan.</text> <paragraph num="(1)"> <text>The center shall have a written emergency medical plan for linkage and access to:</text> <paragraph num="(a)"> <text>Emergency medical care including a health care provider on call in the event that a participant's primary care provider is unavailable;</text> </paragraph> <paragraph num="(b)"> <text>Hospitalization and emergency room care; and</text> </paragraph> <paragraph num="(c)"> <text>Transportation to the center providing the emergency care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The center shall have an established procedure to be followed in an emergency that covers:</text> <paragraph num="(a)"> <text>Immediate care of the participants;</text> </paragraph> <paragraph num="(b)"> <text>Individuals to be notified; and</text> </paragraph> <paragraph num="(c)"> <text>Reports to be prepared.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Activities Programs.</text> <paragraph num="(1)"> <text>Activities Plan.</text> <paragraph num="(a)"> <text>There shall be a written planned program of daily activities that are age appropriate and culturally relevant for individuals served and designed to:</text> <paragraph num="(i)"> <text>Meet the participant's specific needs, preferences, and interests with the individual's cognitive and physical limitations being noted in the development of the activities; and</text> </paragraph> <paragraph num="(ii)"> <text>Stimulate interests, rekindle motivation, and provide opportunities for a variety of types and levels of involvement, including small and large group activities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Staff shall also plan a weekly or monthly calendar of activities that shall be posted in an area of the center where it is plainly visible and easily read by all participants.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Each day's activities shall include:</text> <paragraph num="(a)"> <text>Physical exercise;</text> </paragraph> <paragraph num="(b)"> <text>Rest;</text> </paragraph> <paragraph num="(c)"> <text>Social interaction;</text> </paragraph> <paragraph num="(d)"> <text>Personal care, if needed; and</text> </paragraph> <paragraph num="(e)"> <text>Mental stimulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The center shall permit participants to choose between group and individual activities during some part of the day.</text> </paragraph> <paragraph num="(4)"> <text>Participants shall have the choice of refusing to participate in any activity.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Activities of Daily Living (ADL). Staff shall provide the assistance needed by participants to complete activities of daily living.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Program Components."> <paragraph num="A."> <text>Special Services.</text> <paragraph num="(1)"> <text>The center shall provide or make arrangements for the services listed in §A(2)—(8) of this regulation when the center admits participants that require these services.</text> </paragraph> <paragraph num="(2)"> <text>Diet Modifications. The center shall provide special diets and other diet modifications as ordered by the participant’s health care provider.</text> </paragraph> <paragraph num="(3)"> <text>Rehabilitative Services. Rehabilitative services may include:</text> <paragraph num="(a)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(b)"> <text>Occupational therapy; and</text> </paragraph> <paragraph num="(c)"> <text>Speech pathology provided directly, or indirectly, through arrangements with qualified personnel.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Social Services. A licensed social worker shall provide social work services to participants. If social and emotional needs are identified during the assessment that is required in Regulation .10 of this chapter, a licensed social worker shall be consulted before the establishment of goals to meet those needs.</text> </paragraph> <paragraph num="(5)"> <text>Mental Health Services. When mental health needs are identified, the program shall seek consultation from a mental health professional authorized under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>Services for the Developmentally Disabled. For individuals provided residential services through the Developmental Disabilities Administration, the center shall incorporate the individual plan (IP) in the development of the individual's plan of care and the activities plan.</text> </paragraph> <paragraph num="(7)"> <text>Medical Consultation. The center may use specialists on a part-time or consultant basis in:</text> <paragraph num="(a)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(b)"> <text>Physiatrics;</text> </paragraph> <paragraph num="(c)"> <text>Orthopedics; or</text> </paragraph> <paragraph num="(d)"> <text>Other specialties according to the needs of the participants.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Other Special Services. The center may provide the following services as needed:</text> <paragraph num="(a)"> <text>Alcoholism counseling;</text> </paragraph> <paragraph num="(b)"> <text>Podiatry;</text> </paragraph> <paragraph num="(c)"> <text>Dentistry;</text> </paragraph> <paragraph num="(d)"> <text>Nutrition counseling;</text> </paragraph> <paragraph num="(e)"> <text>Health education; and</text> </paragraph> <paragraph num="(f)"> <text>Other services depending upon need.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Consultants.</text> <paragraph num="(1)"> <text>Except as otherwise provided, when regular employment status, full-time or part-time, is not justified by the needs of the participants, the center may use consultants to meet the service and training needs of the center.</text> </paragraph> <paragraph num="(2)"> <text>When the center uses the services of a consultant, these services shall be specified in a written agreement that is signed and dated by the consultant and the center director.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Medication Services and Policies."> <paragraph num="A."> <text>Written policies for the center shall specify that the RN, LPN, or CMT is authorized to procure, receive, control, and manage the administration of medications at the center.</text> </paragraph> <paragraph num="B."> <text>Medications.</text> <paragraph num="(1)"> <text>Medicine or drugs shall be restricted to those prescribed for the participant by the authorized prescriber.</text> </paragraph> <paragraph num="(2)"> <text>All medications shall be accurately and plainly labeled and kept in the original container issued by the prescriber or pharmacist except as provided in §F(3) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Containers shall be labeled with the:</text> <paragraph num="(a)"> <text>Participant's full name;</text> </paragraph> <paragraph num="(b)"> <text>Authorized prescriber;</text> </paragraph> <paragraph num="(c)"> <text>Prescription number;</text> </paragraph> <paragraph num="(d)"> <text>Name of the medication and dosage;</text> </paragraph> <paragraph num="(e)"> <text>Date of issuance;</text> </paragraph> <paragraph num="(f)"> <text>Expiration date;</text> </paragraph> <paragraph num="(g)"> <text>Refill limits;</text> </paragraph> <paragraph num="(h)"> <text>Directions for use; and</text> </paragraph> <paragraph num="(i)"> <text>Name, address, and telephone number of the pharmacy issuing the drug.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Nurses may not package, repackage, bottle, or label, in whole or in part, any medication in any way by tampering or defacing any labeled medication, except that a nurse may take medications from pharmacy dispensed containers and place the medication in a pill box for the cognitively intact participant who lives independently to self-administer.</text> </paragraph> <paragraph num="D."> <text>When a RN or LPN observes an adverse reaction to a medication, the nurse shall immediately call the:</text> <paragraph num="(1)"> <text>Participant's health care provider;</text> </paragraph> <paragraph num="(2)"> <text>Designee of the participant's health care provider; or</text> </paragraph> <paragraph num="(3)"> <text>The health care provider that is on call for the center.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Drug Administration and Recording.</text> <paragraph num="(1)"> <text>The center shall maintain records of all Schedule II drugs.</text> </paragraph> <paragraph num="(2)"> <text>Written Order.</text> <paragraph num="(a)"> <text>Except as provided in §E(2)(b) of this regulation, medications may not be administered without a written order that has been signed by the authorized health care provider.</text> </paragraph> <paragraph num="(b)"> <text>Medication may only be given based upon a verbal order when the verbal order has been recorded and signed by the RN or the LPN.</text> </paragraph> <paragraph num="(c)"> <text>Verbal orders shall be signed by the authorized health care provider within 30 days.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except as provided in Regulation .14B(2)(c)(iii), only an RN, LPN, or authorized health care provider shall give injectable medication.</text> </paragraph> <paragraph num="(4)"> <text>For those participants who are not capable of self-medicating, the individual assigned the responsibility of administering medications shall:</text> <paragraph num="(a)"> <text>Prepare the dosage;</text> </paragraph> <paragraph num="(b)"> <text>Observe the participant swallowing the oral medication; and</text> </paragraph> <paragraph num="(c)"> <text>Document that the participant has taken the medication.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Staff members who are licensed and certified to administer medications shall make a written record of the medications and treatments that are administered.</text> </paragraph> <paragraph num="(6)"> <text>Orders shall be reviewed and updated in a timely manner, consistent with nursing practice standards, when there is a change in the participant's condition.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Drug Storage.</text> <paragraph num="(1)"> <text>The center shall:</text> <paragraph num="(a)"> <text>Provide a safe, secure, locked place for medicines or drugs, and for making medications available to a participant according to the instructions of his or her health care provider;</text> </paragraph> <paragraph num="(b)"> <text>Store Schedule II drugs in a locked box within the medicine cabinet;</text> </paragraph> <paragraph num="(c)"> <text>Keep medications requiring refrigeration in a separate locked refrigerator or a locked box within a medication refrigerator; and</text> </paragraph> <paragraph num="(d)"> <text>Store medications and medical supplies in a manner that is secured and apart from participant activity areas, food storage areas, and chemical storage areas.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed nurse shall inspect the drug storage conditions at least every 3 months and document his or her findings.</text> </paragraph> <paragraph num="(3)"> <text>The center may keep over-the-counter type medications or supplements that can be purchased without prescription, such as aspirin or antacids, for administration as ordered by the participant's practitioner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Orders."> <paragraph num="A."> <text>Orders concerning medication, treatment, and diet shall be in effect for the specified number of days indicated by the health care provider. If not specified, the period may not exceed 6 months.</text> </paragraph> <paragraph num="B."> <text>Verbal Orders.</text> <paragraph num="(1)"> <text>A licensed nurse shall take verbal medication orders from a health care provider.</text> </paragraph> <paragraph num="(2)"> <text>The nurse shall immediately write orders into the participant's record, and sign and date the note.</text> </paragraph> <paragraph num="(3)"> <text>The original or faxed medication order shall be included in the medical record within 10 calendar days after the date of the telephone order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="First-Aid and Cardiopulmonary Resuscitation."> <paragraph num="A."> <text>At least one staff member who is trained in first aid and in cardiopulmonary resuscitation (CPR) shall be on-site at the center when participants are in attendance, during outings, medical appointments or during transportation of participants.</text> </paragraph> <paragraph num="B."> <text>At least one staff member who is trained in CPR and first aid shall accompany participants taken outside of the center for outings and other activities.</text> </paragraph> <paragraph num="C."> <text>First aid administered by staff shall be limited to that necessary to preserve life or to prevent further immediate danger.</text> </paragraph> <paragraph num="D."> <text>Staff shall receive first aid and CPR training from a certified provider approved by the Department. Recertification shall be obtained according to the guidelines of the certified provider.</text> </paragraph> <paragraph num="E."> <text>The center shall have adequate first aid supplies available for treating shock, burns, and small, medium, and large wounds.</text> </paragraph> <paragraph num="F."> <text>On a 90-day basis, staff shall inspect first aid supplies in the center and in the vehicle or vehicles used for transporting participants. Expiration dates of supplies and the maintenance of supplies at the required levels shall be included in the inspection. The findings of the inspection shall be documented at least quarterly.</text> </paragraph> <paragraph num="G."> <text>Supplies with an expired date shall be replaced immediately.</text> </paragraph> <paragraph num="H."> <text>The center shall conspicuously post a chart clearly describing first aid and emergency medical treatment techniques and the names and phone numbers of health care providers, ambulances, and medical facilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Nutrition."> <paragraph num="A."> <text>The center shall ensure that each participant who is present for 4 or more hours is provided with a meal that meets 1/3 of the recommended dietary allowance of the Food and Nutrition Board of the National Research Council.</text> </paragraph> <paragraph num="B."> <text>The center shall provide snacks consisting of a nourishing food or beverage, or both, to participants.</text> </paragraph> <paragraph num="C."> <text>The minimum number of meals and snacks shall be provided as follows:</text> </paragraph> <paragraph num="D."> <text>A center may prepare food on-site if the center meets the requirements of COMAR 10.15.03.</text> </paragraph> <paragraph num="E."> <text>The center shall ensure that food prepared off-site from the center is prepared in a center which meets the requirements of COMAR 10.15.03.</text> </paragraph> <paragraph num="F."> <text>Therapeutic diets approved by a registered and licensed dietitian shall be served only as ordered.</text> </paragraph> <paragraph num="G."> <text>Staff shall assist participants who may be unable to feed themselves, in accordance with the ADCAPS.</text> </paragraph> <paragraph num="H."> <text>A Registered Dietitian shall perform a nutritional assessment for all participants with a potential, or an actual, nutritional deficit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Comprehensive Assessments."> <paragraph num="A."> <text>The participant shall receive a comprehensive assessment (ADCAPS) that is designed to evaluate the participant's strengths and needs. A registered nurse shall complete the initial assessment within 30 days of a participant's admission and every 120 days thereafter as long as there is no change in the participant's condition. The assessment shall include:</text> <paragraph num="(1)"> <text>Health status;</text> </paragraph> <paragraph num="(2)"> <text>Functional status;</text> </paragraph> <paragraph num="(3)"> <text>Participation in activities;</text> </paragraph> <paragraph num="(4)"> <text>Nutritional status;</text> </paragraph> <paragraph num="(5)"> <text>Psychosocial status; and</text> </paragraph> <paragraph num="(6)"> <text>Home management skills.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Regardless of the schedule in §A of this regulation, the licensed or certified professional health care provider shall complete a reassessment by the end of the participant's next day of attendance when any significant change in the participant's condition occurs. The practitioner shall perform a follow-up evaluation of any significant change, and document the evaluation in the participant's medical record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Care Planning."> <paragraph num="A."> <text>Individualized Plan of Care.</text> <paragraph num="(1)"> <text>There shall be an individualized plan of care completed for each participant within 30 days following admission.</text> </paragraph> <paragraph num="(2)"> <text>The participant shall participate in the development of the plan of care, along with the multidisciplinary team, unless the center documents the reasons why the participant is unable or unwilling to participate.</text> </paragraph> <paragraph num="(3)"> <text>The plan of care shall be consistent with the comprehensive assessment and shall include a problem list.</text> </paragraph> <paragraph num="(4)"> <text>A registered nurse shall update the plan of care within 7 calendar days of a participant's change in status, but not less than semiannually.</text> </paragraph> <paragraph num="(5)"> <text>The participant's plan of care shall be based on the comprehensive assessment that is completed by registered nurse as described in Regulation .21 of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>The plan of care shall include:</text> <paragraph num="(a)"> <text>Orders by a Health care provider;</text> </paragraph> <paragraph num="(b)"> <text>All pertinent diagnoses;</text> </paragraph> <paragraph num="(c)"> <text>Frequency and types of services required;</text> </paragraph> <paragraph num="(d)"> <text>Treatment goals for each type of service ordered;</text> </paragraph> <paragraph num="(e)"> <text>Rehabilitation, services, and prognosis;</text> </paragraph> <paragraph num="(f)"> <text>Functional and cognitive limitations;</text> </paragraph> <paragraph num="(g)"> <text>Level of activity permitted;</text> </paragraph> <paragraph num="(h)"> <text>Diet;</text> </paragraph> <paragraph num="(i)"> <text>Medication and treatment or treatments;</text> </paragraph> <paragraph num="(j)"> <text>Measurable goals for each problem or need that is identified;</text> </paragraph> <paragraph num="(k)"> <text>Goals that are realistic, practical, and tailored to the desired outcome for the participant; and</text> </paragraph> <paragraph num="(l)"> <text>Approaches to accomplishing each goal.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The multidisciplinary team shall document all components of the participant's care plan in the participant's medical record;</text> </paragraph> <paragraph num="(8)"> <text>The center shall give family members, and others designated by the individual with proper consent or responsible parties, an opportunity to participate in the care plan meeting.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Attendance and Unscheduled Absences.</text> <paragraph num="(1)"> <text>Staff shall maintain daily records on each participant's attended days of care.</text> </paragraph> <paragraph num="(2)"> <text>When a participant is absent on a scheduled day, staff shall investigate on the day of the occurrence to learn the reason for the absence and document the reason.</text> </paragraph> <paragraph num="(3)"> <text>The center shall have documentation that:</text> <paragraph num="(a)"> <text>Absences are reviewed on at least a 30-day basis; and</text> </paragraph> <paragraph num="(b)"> <text>Appropriate action has been taken.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Use of Restraints."> <paragraph num="A."> <text>Policy and Procedures. The center shall have a policy and procedure on the use of any device or medication for the specific purpose of restricting the participant's freedom of motion or movement within the center.</text> </paragraph> <paragraph num="B."> <text>A participant has the right to be free of restraints used in violation of this chapter</text> </paragraph> <paragraph num="C."> <text>Improper Use of Chemicals or Drugs. Chemicals or drugs may not be used for participants in the following ways:</text> <paragraph num="(1)"> <text>In excessive dose, including duplicate drug therapy;</text> </paragraph> <paragraph num="(2)"> <text>For excessive duration, without adequate monitoring;</text> </paragraph> <paragraph num="(3)"> <text>Without adequate indications for its use; or</text> </paragraph> <paragraph num="(4)"> <text>In the presence of adverse consequences which indicate the dose should be reduced or discontinued.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Improper Use of Physical Restraints. Participants may not be physically restrained:</text> <paragraph num="(1)"> <text>For discipline or convenience; or</text> </paragraph> <paragraph num="(2)"> <text>If a restraint is not ordered by a physician to treat the participant's symptoms or medical conditions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Restraint Orders.</text> <paragraph num="(1)"> <text>All restraints shall be ordered by a physician and shall specify:</text> <paragraph num="(a)"> <text>The purpose of the restraint;</text> </paragraph> <paragraph num="(b)"> <text>The type of restraint to be used; and</text> </paragraph> <paragraph num="(c)"> <text>The length of time the restraint shall be used.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A participant may not have an as-needed restraint order.</text> </paragraph> <paragraph num="(3)"> <text>Orders for the use of a restraint shall be time specific.</text> </paragraph> <paragraph num="(4)"> <text>A participant may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity.</text> </paragraph> <paragraph num="(5)"> <text>If an order for the use of a restraint is to be continued, the order shall be renewed at least every 7 days by a physician.</text> </paragraph> <paragraph num="(6)"> <text>The health care provider shall provide training to staff in the appropriate use of the restraint ordered by the physician.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The program shall notify the participant's family or the participant's representative each time a restraint is used.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Discharge."> <paragraph num="A."> <text>Before a center discharges a participant, the center shall:</text> <paragraph num="(1)"> <text>Formulate a discharge plan, including at least a 30-day written advance notice to the participant or the participant's responsible party; and</text> </paragraph> <paragraph num="(2)"> <text>Assist the participant in obtaining the resources needed to implement the plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The 30-day written notice of discharge specified in §A of this regulation is not required when:</text> <paragraph num="(1)"> <text>The health or safety of the participant or other individuals in the center would be endangered by the continued presence of the participant;</text> </paragraph> <paragraph num="(2)"> <text>The participant has urgent medical needs; or</text> </paragraph> <paragraph num="(3)"> <text>There is an emergency requiring less than 30 days notice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In circumstances described in §B(1), (2) or (3) of this regulation, the center shall provide written notice of discharge as soon as practicable before discharge.</text> </paragraph> <paragraph num="D."> <text>The center shall document in the participant's discharge summary the reasons for discharge and the center or location to which the participant was discharged.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Reports and Actions Required in Unusual Occurrences."> <paragraph num="A."> <text>The center shall immediately report an occurrence such as a communicable disease or food-borne outbreak, poisoning, death, fire, use of restraints or other unusual incident that threatens the health or safety of any participant or staff member to:</text> <paragraph num="(1)"> <text>The Office of Health Care Quality;</text> </paragraph> <paragraph num="(2)"> <text>The local health officer, as required by law;</text> </paragraph> <paragraph num="(3)"> <text>Participant; and</text> </paragraph> <paragraph num="(4)"> <text>Family and, if applicable, guardian.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The center shall document the incident in the participant's medical record or the staff member's personnel file, if applicable.</text> </paragraph> <paragraph num="C."> <text>Staff shall report cases of abuse, neglect, self-neglect, or exploitation of participants to the:</text> <paragraph num="(1)"> <text>Local police;</text> </paragraph> <paragraph num="(2)"> <text>Department; and</text> </paragraph> <paragraph num="(3)"> <text>Local department of social services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a participant becomes a danger to self or others the center shall, as appropriate, contact the local emergency system or immediately notify the participant's licensed or certified professional health care provider and the participant's family or caregiver.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Records."> <paragraph num="A."> <text>Records. The center shall maintain records that are needed to operate the center, as required by the Department, and to document the progress of the participants.</text> </paragraph> <paragraph num="B."> <text>Retention. The center shall maintain participants' records for at least 5 years from the date of discharge, except as provided in Health-General Article, §4-403, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Confidentiality. The center shall maintain records so that they are accessible only to the director, the staff, emergency personnel, and to funding and monitoring agencies. The center may not discuss or reveal the contents of the records with any persons other than those listed above without the participant's written permission.</text> </paragraph> <paragraph num="D."> <text>Required Records.</text> <paragraph num="(1)"> <text>Participant Records. The center shall maintain at least the following information for each participant:</text> <paragraph num="(a)"> <text>Name, age, sex, address, and telephone number;</text> </paragraph> <paragraph num="(b)"> <text>Name and telephone number of the individual to be notified in case of emergency;</text> </paragraph> <paragraph num="(c)"> <text>Next of kin;</text> </paragraph> <paragraph num="(d)"> <text>Medicare, Medicaid, or private insurance member enrollment numbers related to health care benefits;</text> </paragraph> <paragraph num="(e)"> <text>Name and address of primary care provider, with changes noted and dated when change occurs;</text> </paragraph> <paragraph num="(f)"> <text>Functional assessment with original and revised versions noting participant progress;</text> </paragraph> <paragraph num="(g)"> <text>Assessment of the home environment at the time of intake and as needed, or at change of home address;</text> </paragraph> <paragraph num="(h)"> <text>Individual plan of care;</text> </paragraph> <paragraph num="(i)"> <text>Admission physical and subsequent additional information;</text> </paragraph> <paragraph num="(j)"> <text>Medications and adverse drug reactions; and</text> </paragraph> <paragraph num="(k)"> <text>Accidents.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Personnel Records. The center shall maintain the following information for each staff member:</text> <paragraph num="(a)"> <text>Name, age, sex, address, and telephone number;</text> </paragraph> <paragraph num="(b)"> <text>Educational background;</text> </paragraph> <paragraph num="(c)"> <text>Employment history and notes on references;</text> </paragraph> <paragraph num="(d)"> <text>Performance evaluations and attendance;</text> </paragraph> <paragraph num="(e)"> <text>Individual to be notified in case of emergency;</text> </paragraph> <paragraph num="(f)"> <text>Documentation that the individual is free from tuberculosis, measles, mumps, rubella, and varicella as evidenced by:</text> <paragraph num="(i)"> <text>Physician’s statement;</text> </paragraph> <paragraph num="(ii)"> <text>Positive disease histories affirmed by employee’s signature;</text> </paragraph> <paragraph num="(iii)"> <text>Antibody serology’s of titer;</text> </paragraph> <paragraph num="(iv)"> <text>Skin tests; or</text> </paragraph> <paragraph num="(v)"> <text>Statement of vaccinations, affirmed by the employee signature;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Evidence that the annual influenza vaccine has been advised;</text> </paragraph> <paragraph num="(h)"> <text>Any impairment which would hinder the performance of assigned responsibilities; and</text> </paragraph> <paragraph num="(i)"> <text>Documentation of a criminal history records check in accordance with Health-General Article, §19-1901, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(j)"> <text>The official driving record and a copy of a valid driver's license if driving is a condition of employment; and</text> </paragraph> <paragraph num="(k)"> <text>Copies of written agreements with consultants, including services to be provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Volunteer Records.</text> <paragraph num="(a)"> <text>The center shall urge that volunteers accept annual influenza vaccination and tuberculin testing as considered necessary by the center.</text> </paragraph> <paragraph num="(b)"> <text>The center shall give appropriate health care information to such volunteers to provide maximum protection to residents.</text> </paragraph> <paragraph num="(c)"> <text>The center shall maintain documentation of the discussion between the center and the volunteer concerning influenza vaccine and tuberculin testing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Administrative and Fiscal Records. The center shall maintain the following administrative and fiscal records:</text> <paragraph num="(a)"> <text>Expenditures with substantiating documentation;</text> </paragraph> <paragraph num="(b)"> <text>Current and projected annual operating budgets, including specific cost allocations and formula for determining projected expenditures, and including accurate per diem costs;</text> </paragraph> <paragraph num="(c)"> <text>Fee charged, and fee schedule, if appropriate;</text> </paragraph> <paragraph num="(d)"> <text>Records of in-service training offered by the center;</text> </paragraph> <paragraph num="(e)"> <text>Current inspection reports from the health and fire departments;</text> </paragraph> <paragraph num="(f)"> <text>The daily schedule of activities;</text> </paragraph> <paragraph num="(g)"> <text>Daily menu of meals and snacks served for a 30-day period;</text> </paragraph> <paragraph num="(h)"> <text>Attendance records; and</text> </paragraph> <paragraph num="(i)"> <text>Audit reports.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Transportation."> <paragraph num="A."> <text>The center shall provide or arrange transportation to enable participants to attend the center and to participate in activity outings, medical appointments, or other participant required services.</text> </paragraph> <paragraph num="B."> <text>The center and its staff shall operate vehicles in accordance with all applicable federal, State, and local requirements.</text> </paragraph> <paragraph num="C."> <text>A participant may not be in transit for more than 1 hour without an opportunity for a rest stop:</text> <paragraph num="(1)"> <text>For a period of 2 years after the final adoption of Regulation .14A(1)(a) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Two years after the final adoption of Regulation .14A(1)(a) of this chapter, the center shall utilize the ADCAPS to determine the length of time a participant may be in transit without a rest stop.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A participant may not be brought to or left at the center when staff is not present.</text> </paragraph> <paragraph num="E."> <text>A participant may not be left in a vehicle when staff is not present, except when the driver is assisting participants to and from their residences and the driver is within eyesight of the vehicle.</text> </paragraph> <paragraph num="F."> <text>Centers shall promote and manage vehicle safety, driver safety, accident control and reporting, and driver corrective action efforts.</text> </paragraph> <paragraph num="G."> <text>A driver may not leave a participant at a home until the participant is met at the home or enters the home.</text> </paragraph> <paragraph num="H."> <text>If assistance is needed due to the participant’s documented mobility limitations, a driver shall assist the participant to their home.</text> </paragraph> <paragraph num="I."> <text>Driver Training.</text> <paragraph num="(1)"> <text>The center shall provide driver training to all employees who are expected to operate motor vehicles as part of their official responsibilities.</text> </paragraph> <paragraph num="(2)"> <text>The following topics shall be included in the driver training:</text> <paragraph num="(a)"> <text>Review of State vehicle law;</text> </paragraph> <paragraph num="(b)"> <text>Approaches for defensive driving; and</text> </paragraph> <paragraph num="(c)"> <text>Control of aggressive driver behavior.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>The center shall assure that activities and field trips are staffed in accordance with participant needs as documented in the ADCAPS.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Physical Plant."> <paragraph num="A."> <text>New Center.</text> <paragraph num="(1)"> <text>A new center shall be designed, constructed, and maintained according to applicable federal, State, and local codes and regulations for building, zoning, fire, food, safety, health and other related codes or ordinances, or both. The center shall also comply with the requirements of the Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.</text> </paragraph> <paragraph num="(2)"> <text>Where possible, the center shall be located at street level. If a proposed center will not be located at street level, the licensee shall obtain prior approval from the Department before design work proceeds.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Existing Center. Any conversion, alteration, or addition that affects the center's functional structure or participant capacity, shall be constructed in accordance with this chapter, including the regulations that apply to new centers.</text> </paragraph> <paragraph num="C."> <text>Multi-Use Facilities.</text> <paragraph num="(1)"> <text>When a center operates in a multi-use center such as a hospital, nursing home, assisted living program, religious structure, or a school, the center shall have a written agreement regarding the cooperative use of facilities allowing the center adequate separate space during its hours of operation.</text> </paragraph> <paragraph num="(2)"> <text>Certain spaces may be shared with other groups, such as the kitchen and therapy rooms. Where spaces are to be shared, a written agreement shall govern the use of space.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Space.</text> <paragraph num="(1)"> <text>The center shall have sufficient space to accommodate the full range of program activities and services. The center shall be flexible and adaptable to accommodate a variety of group or individual activities and services, and to protect the privacy of participants receiving services. The Department may require more than the minimum square footage to ensure that there is space for the center to provide activities and services that meet the needs of the participants.</text> </paragraph> <paragraph num="(2)"> <text>The center shall have the following minimum square footage requirements for activity space:</text> <paragraph num="(a)"> <text>100 square feet for each of the first five participants; and</text> </paragraph> <paragraph num="(b)"> <text>60 square feet per participant thereafter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Usable Area. In determining required square footage, only those activity areas commonly used by participants are to be included. Fifty percent of the total usable square footage of kitchen areas shall qualify as activity space if participants use these areas as part of the center's activities programs.</text> </paragraph> <paragraph num="(4)"> <text>Non-Usable Area. Administrative areas, reception areas, offices, closets, storage rooms, toilets and bathrooms, utility rooms, and passageways may not be included when calculating the qualifying usable square footage for activities. The actual footprint of finished space shall be what constitutes usable space. This excludes the space between partition walls, and the space between the finished interior wall and the outside of the exterior wall.</text> </paragraph> <paragraph num="(5)"> <text>The center shall provide the following:</text> <paragraph num="(a)"> <text>Private space to permit staff to work effectively and without interruption;</text> </paragraph> <paragraph num="(b)"> <text>A large room or access to a large room where all participants can gather and rooms or divided areas for small group activities;</text> </paragraph> <paragraph num="(c)"> <text>A designated rest or quiet area to provide visual privacy to isolate participants that become ill or disruptive or who may require rest;</text> </paragraph> <paragraph num="(d)"> <text>A separate space where participants, family, caregivers, or staff may have private conversations;</text> </paragraph> <paragraph num="(e)"> <text>Adequate space that is located in or adjacent to activity areas or offices for storage of activity and operating supplies.</text> </paragraph> <paragraph num="(f)"> <text>Exterior lockable doors; and</text> </paragraph> <paragraph num="(g)"> <text>An effective automated device or system to alert staff to participants entering or leaving the building.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The center need not use an automated alert for an exit door when the exit door is staffed by a receptionist or other staff member who views and maintains a log of the participants entering and leaving the center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Emergency Preparedness."> <paragraph num="A."> <text>The center shall develop an emergency and disaster plan that includes policies and procedures that shall be followed before, during, and after an emergency or disaster, including:</text> <paragraph num="(1)"> <text>The safe management of individuals who are receiving services at the adult medical day care center when an emergency occurs;</text> </paragraph> <paragraph num="(2)"> <text>Notification of families, staff and licensing authorities regarding the action that will be taken concerning the safety and well-being of the participants;</text> </paragraph> <paragraph num="(3)"> <text>Staff coverage, organization, and assignment of responsibilities; and</text> </paragraph> <paragraph num="(4)"> <text>The continuity of operations, including procedures to secure access to essential goods, equipment, and services to sustain operation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A center is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the center under this regulation.</text> </paragraph> <paragraph num="C."> <text>This regulation does not prohibit an adult medical day care center from applying for and receiving reimbursement:</text> <paragraph num="(1)"> <text>Under any applicable insurance policy; or</text> </paragraph> <paragraph num="(2)"> <text>From any state or federal funds that may be available due to a declared state or federal emergency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For purposes of coordinating local emergency planning efforts a center shall provide access to the emergency plans developed under this regulation to local organizations for emergency management.</text> </paragraph> <paragraph num="E."> <text>The center shall provide OHCQ a contact phone number, providing direct access to the center or center’s representative that shall be available 24 hours a day, 7 days a week.</text> </paragraph> <paragraph num="F."> <text>Evacuation Plans. The center shall conspicuously post individual floor plans with designated evacuation routes on each floor.</text> </paragraph> <paragraph num="G."> <text>Orientation and Drills.</text> <paragraph num="(1)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Orient staff to the emergency and disaster plan and to their individual responsibilities within 24 hours of the commencement of job duties; and</text> </paragraph> <paragraph num="(b)"> <text>Document completion of the orientation in the staff member's personnel file through the signature of the employee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fire Drills.</text> <paragraph num="(a)"> <text>The center shall conduct fire drills at least quarterly on all shifts.</text> </paragraph> <paragraph num="(b)"> <text>Documentation. The center shall:</text> <paragraph num="(i)"> <text>Document completion of each drill; and</text> </paragraph> <paragraph num="(ii)"> <text>Maintain the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Semiannual Disaster Drill.</text> <paragraph num="(a)"> <text>The center shall conduct a semiannual emergency and disaster drill on all shifts during which it practices evacuating participants or sheltering in-place so that each is practiced at least one time a year.</text> </paragraph> <paragraph num="(b)"> <text>The drills may be conducted via a table-top exercise if the program can demonstrate that moving participants will be harmful to the participants.</text> </paragraph> <paragraph num="(c)"> <text>Documentation. The center shall:</text> <paragraph num="(i)"> <text>Document completion of each disaster drill or training session;</text> </paragraph> <paragraph num="(ii)"> <text>Have all staff who participated in the drill or training sign the document;</text> </paragraph> <paragraph num="(iii)"> <text>Document any opportunities for improvement as identified as a result of the drill; and</text> </paragraph> <paragraph num="(iv)"> <text>Keep the documentation on file for a minimum of 2 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The licensee shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Furniture, Furnishings, and Supplies."> <paragraph num="A."> <text>Furniture.</text> <paragraph num="(1)"> <text>The furniture in a center shall be:</text> <paragraph num="(a)"> <text>Appropriate for use by individuals with disabilities;</text> </paragraph> <paragraph num="(b)"> <text>Sturdy and secure so that it cannot easily tip when used for support while walking or seated;</text> </paragraph> <paragraph num="(c)"> <text>Designed so that it is used easily by individuals with limited agility, permitting feet to rest on the floor and having armrests; and</text> </paragraph> <paragraph num="(d)"> <text>Clean, safe, and in good repair.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The center shall have sufficient furniture for the entire participant population. Straight-backed chairs with armrests shall be available for use by participants during activities and meal times.</text> </paragraph> <paragraph num="(3)"> <text>The center shall have at least:</text> <paragraph num="(a)"> <text>One chair for each participant and each staff member;</text> </paragraph> <paragraph num="(b)"> <text>Adequate table space for all participants;</text> </paragraph> <paragraph num="(c)"> <text>Reclining lounge chairs, the number to be determined by the needs and numbers of participants; and</text> </paragraph> <paragraph num="(d)"> <text>A bed for medical examinations and for temporary holdover for participants who become ill or upset.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Furnishings.</text> <paragraph num="(1)"> <text>Floor Coverings. All rugs and floor coverings shall be secured to the floor to eliminate tripping hazards.</text> </paragraph> <paragraph num="(2)"> <text>All equipment and furnishings shall be in good condition and safe for use by participants and staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Equipment and Supplies.</text> <paragraph num="(1)"> <text>The center shall provide equipment to encourage active participation and group interaction. The materials shall reflect the interests and backgrounds of the participants.</text> </paragraph> <paragraph num="(2)"> <text>Environmental aids and supplies for activities of daily living shall be provided as required by the participant's needs and the goals of the center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Work Stations."> <paragraph num="A."> <text>The center shall provide at least one work station for use of nurses, social workers, program assistants, or other appropriate staff and consultants.</text> </paragraph> <paragraph num="B."> <text>Work stations shall have sufficient storage space for records and to meet the needs of the center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Infection Control."> <text>There shall be sufficient hand-washing facilities to ensure that employees maintain adequate infection control procedures.</text> </regulation> <regulation prefix="Regulation" num=".33" heading="Food Service Area."> <paragraph num="A."> <text>Whether prepared on-site or off-site, food shall:</text> <paragraph num="(1)"> <text>Be prepared and served under sanitary conditions; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of COMAR 10.15.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall approve all plans for the construction and renovation of facilities and equipment in food service areas.</text> </paragraph> <paragraph num="C."> <text>All food service areas shall include, at a minimum:</text> <paragraph num="(1)"> <text>At least one hand-washing sink;</text> </paragraph> <paragraph num="(2)"> <text>At least one three-compartment sink or one commercial grade dishwashing machine;</text> </paragraph> <paragraph num="(3)"> <text>Surfaces, floors, walls, cabinets, and counters, that is easily cleanable;</text> </paragraph> <paragraph num="(4)"> <text>Adequate and separate storage for dry food goods;</text> </paragraph> <paragraph num="(5)"> <text>Adequate refrigerated storage for perishable and frozen foods;</text> </paragraph> <paragraph num="(6)"> <text>Adequate and separate storage for cleaning products and chemical agents;</text> </paragraph> <paragraph num="(7)"> <text>Adequate and separate facilities for housekeeping of the food service area or areas;</text> </paragraph> <paragraph num="(8)"> <text>A minimum of one Class ABC fire extinguisher, in or adjacent to all food service area or areas;</text> </paragraph> <paragraph num="(9)"> <text>A minimum of one telephone, with posted emergency telephone numbers, close to all food service area or areas; and</text> </paragraph> <paragraph num="(10)"> <text>For new construction, a separate entrance for deliveries and removal of refuse, with exterior storage of refuse near the food service area or areas.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In centers where food service area or areas are used for activities, the center shall take precautions to prevent participant access to cleaning products and other potentially dangerous utensils or equipment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Bathrooms."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>Bathrooms shall be located not more than 30 feet from the primary activity areas.</text> </paragraph> <paragraph num="(2)"> <text>The center shall provide at least one toilet and one hand-washing sink for every 10 participants. Additional toilets and hand-washing sinks may be required based upon the toileting needs of the participants.</text> </paragraph> <paragraph num="(3)"> <text>Bathrooms shall be accessible to individuals in compliance with the requirements of the Americans with Disabilities Act of 1990.</text> </paragraph> <paragraph num="(4)"> <text>The center shall provide individual paper towels, a trash receptacle, soap, and toilet paper in bathrooms at all times. These supplies and equipment shall be accessible to participants at all times.</text> </paragraph> <paragraph num="(5)"> <text>Space and equipment shall be provided in bathrooms, to maintain privacy while cleaning or changing the clothing of participants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Change of Clothes. The center shall make arrangements with the family or residential caregiver to store a set of clothing at the center for use if a participant becomes incontinent during his or her stay at the center.</text> </paragraph> <paragraph num="C."> <text>Drinking water may not be obtained from a bathroom.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Laundry Facilities."> <paragraph num="A."> <text>Laundry facilities shall be available on-site for use if a participant's clothing becomes soiled while he or she is at the center.</text> </paragraph> <paragraph num="B."> <text>The area or areas where laundry facilities are located shall be equipped with exhaust ventilation, secure chemical storage, and dryer lint exhaust and control.</text> </paragraph> <paragraph num="C."> <text>The center shall maintain laundry facilities in a safe and sanitary manner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Water Supply."> <paragraph num="A."> <text>Water Supply. A center shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be used if the Department of the Environment approves the source in accordance with COMAR 26.04.02.</text> </paragraph> <paragraph num="B."> <text>Loss of Water Supply. The center shall establish written emergency procedures that enable the center to have water in all essential areas in the event of the loss of the normal water supply.</text> </paragraph> <paragraph num="C."> <text>Adequacy of Water Pressure. The water supply shall be adequate in quantity and be delivered under sufficient pressure to satisfactorily serve fixtures in the center. A minimum pressure of 15 pounds per square inch shall be maintained at top floor fixtures during peak demand period.</text> </paragraph> <paragraph num="D."> <text>Water Temperature. The water heating equipment shall supply adequate amounts of water as follows:</text> <paragraph num="(1)"> <text>Washing, bathing, and other personal use, not more than 120°F or less than 100°F; and</text> </paragraph> <paragraph num="(2)"> <text>Food preparation, in conformance with COMAR 10.15.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Plumbing and Sewage."> <paragraph num="A."> <text>Plumbing. All plumbing in a center shall be installed and maintained according to all applicable federal, State, and local building codes and sanitation regulations.</text> </paragraph> <paragraph num="B."> <text>Sewage. A center shall be served by an approved public sewage disposal system, if available. If no approved public sewerage system is available, a private sewage disposal system may be used if the Department of the Environment approves the system according to COMAR 26.04.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Heating, Air Conditioning, and Ventilation."> <paragraph num="A."> <text>Heating.</text> <paragraph num="(1)"> <text>The center shall have a properly maintained and operating central heating system that is capable of maintaining 75°F throughout the participants' section of the building.</text> </paragraph> <paragraph num="(2)"> <text>The heating system shall comply with NFPA 101, Life Safety Code, which is incorporated by reference in COMAR 29.06.01.06, and all applicable State and local codes.</text> </paragraph> <paragraph num="(3)"> <text>A center may not use space heaters or portable heaters unless approved by the State or local fire authority.</text> </paragraph> <paragraph num="(4)"> <text>The center shall ensure that all exposed heating pipes, hot water pipes, and radiators are covered or protected to prevent exposure to participants, staff, and visitors.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Air Conditioning. The center shall have a properly maintained and operating air conditioning system capable of maintaining a maximum temperature of 81°F throughout the participants' section of the building.</text> </paragraph> <paragraph num="C."> <text>Ventilation.</text> <paragraph num="(1)"> <text>Existing Centers. The center shall ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, or other noxious odors. The center shall provide forced mechanical exhaust or an approved equivalent for:</text> <paragraph num="(a)"> <text>All bathing compartments;</text> </paragraph> <paragraph num="(b)"> <text>Toilet rooms;</text> </paragraph> <paragraph num="(c)"> <text>Designated smoking rooms, if applicable; and</text> </paragraph> <paragraph num="(d)"> <text>Other rooms, as determined by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>New Centers. In addition to the requirements in §C(1) of this regulation, new centers shall meet the following minimum ventilation rates:</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Lighting."> <paragraph num="A."> <text>The center shall ensure that lighting levels in all areas are appropriate for the type of activity.</text> </paragraph> <paragraph num="B."> <text>Glare from windows exposed to direct sunlight shall be kept at a minimum by using window coverings and glare from lights shall be kept at a minimum by using shaded light fixtures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Sanitation."> <paragraph num="A."> <text>The center shall have sufficient maintenance and housekeeping personnel to assure that the center is clean, orderly, attractive, and safe at all times.</text> </paragraph> <paragraph num="B."> <text>The center shall ensure that maintenance and housekeeping activities are completed on a regular basis and according to generally accepted sanitation standards. Maintenance and housekeeping functions may not interfere with the provision of care or the activities program of the center.</text> </paragraph> <paragraph num="C."> <text>The center shall develop and implement a written plan for preventive maintenance and repair of the center.</text> </paragraph> <paragraph num="D."> <text>Insects and Rodents.</text> <paragraph num="(1)"> <text>The center shall:</text> <paragraph num="(a)"> <text>Be maintained free of insects and rodents;</text> </paragraph> <paragraph num="(b)"> <text>Maintain control measures to prevent infestation by insects and vermin; and</text> </paragraph> <paragraph num="(c)"> <text>Ensure that all control measures are conducted using approved methods.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The use of pesticides shall be controlled so that participants, staff, and visitors are not exposed to fumes or residues. Application of pesticides shall be scheduled at a time when participants are not in the center.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Refuse.</text> <paragraph num="(1)"> <text>The center shall store refuse in water-tight containers with tight-fitting covers. Containers shall be emptied at frequent intervals and be thoroughly scoured and aired before reuse.</text> </paragraph> <paragraph num="(2)"> <text>The outside storage area for garbage shall be constructed of impervious materials.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Special Medical Waste. The center shall dispose of special medical waste in accordance with all federal, State, and local laws and regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Safety."> <paragraph num="A."> <text>Fire Safety. The center shall comply with the provisions of:</text> <paragraph num="(1)"> <text>COMAR 20.06.01;</text> </paragraph> <paragraph num="(2)"> <text>NFPA 101 Life Safety Code, which is incorporated by reference in COMAR 29.06.01.06; and</text> </paragraph> <paragraph num="(3)"> <text>All other applicable federal, State, and local fire codes and regulations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A center that is located within a licensed nursing home or hospital shall meet the applicable requirements of NFPA 101 Life Safety Code.</text> </paragraph> <paragraph num="C."> <text>The center shall ensure that a floor plan with evacuation routes from the center is posted in each separate space, room, and corridor of the center.</text> </paragraph> <paragraph num="D."> <text>The center shall have at least two well-identified exits. Stairs, ramps, and interior floors shall have nonslip surfaces. Handrails shall be installed on all interior and exterior stairs and ramps. Stairways and hallways shall be well lit and kept free of obstructions.</text> </paragraph> <paragraph num="E."> <text>The center shall ensure that drugs, cleaning agents, chemicals, pesticides, and other poisonous products are secured for the safety of the participants, staff, and visitors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="Smoking."> <paragraph num="A."> <text>The center shall prohibit smoking in all indoor areas in accordance with COMAR 09.12.23.</text> </paragraph> <paragraph num="B."> <text>If smoking is permitted in exterior areas, the center shall establish and implement smoking policies and procedures that minimize the risk of fire.</text> </paragraph> <paragraph num="C."> <text>The smoking policies and procedures shall include at least the following provisions:</text> <paragraph num="(1)"> <text>The center shall prohibit smoking in any hazardous location where flammable liquids, combustible gases, or oxygen are stored;</text> </paragraph> <paragraph num="(2)"> <text>The center shall designate smoking areas with ashtrays of noncombustible material and safe design;</text> </paragraph> <paragraph num="(3)"> <text>Participants shall be supervised at all times while smoking; and</text> </paragraph> <paragraph num="(4)"> <text>If the center has an exterior designated smoking area, this area may not be located at the front entrance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".43" heading="Sanctions."> <paragraph num="A."> <text>If the Department determines that a deficiency or deficiencies exist, the Secretary may impose sanctions against the licensee.</text> </paragraph> <paragraph num="B."> <text>The Secretary may impose the following sanctions, as appropriate:</text> <paragraph num="(1)"> <text>Direct the licensee to correct the deficiencies in a specific manner or within a specific time frame, or both;</text> </paragraph> <paragraph num="(2)"> <text>Require the center to use the services of a management firm that is approved by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Mandate staffing patterns that specify the number of personnel or personnel qualifications, or both;</text> </paragraph> <paragraph num="(4)"> <text>Appoint a State monitor, as described in Regulation .44 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Restrict the number of participants that a center may admit;</text> </paragraph> <paragraph num="(6)"> <text>Impose a civil money penalty;</text> </paragraph> <paragraph num="(7)"> <text>Impose emergency suspension of license; and</text> </paragraph> <paragraph num="(8)"> <text>Deny or revoke a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction the Secretary may revoke the license.</text> </paragraph> <paragraph num="D."> <text>Grievances.</text> <paragraph num="(1)"> <text>A licensee that is aggrieved by the imposition of a sanction under §B(4)—(8) or C of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A licensee that is aggrieved by the imposition of a sanction under §B(2) and (3) of this regulation may request a show cause hearing before the Director of the Office of Health Care Quality to show cause why these remedies should not be enforced.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".44" heading="State Monitor."> <paragraph num="A."> <text>If the Department determines that a deficiency or deficiencies exist, the Department may appoint a State monitor who is qualified on the basis of education and experience to oversee correction of the deficiencies.</text> </paragraph> <paragraph num="B."> <text>The duties of the State monitor shall be specified in a written agreement between the Department and the State monitor and shall include, but are not limited to:</text> <paragraph num="(1)"> <text>Conducting periodic on-site inspections to assess the center's compliance with regulations of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Making recommendations to achieve compliance with State regulations; and</text> </paragraph> <paragraph num="(3)"> <text>Issuing written reports to the Department and the center detailing the findings of the on-site inspections and the status of recommended actions that the center shall complete to achieve compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The State monitor shall function for a period of time specified by the Department. The center may request rescission or modification of the duration of the State monitor's appointment at intervals of not less than 120 days from the date of appointment.</text> </paragraph> <paragraph num="D."> <text>The State monitor may not be an employee of the Department.</text> </paragraph> <paragraph num="E."> <text>The State monitor's salary shall be:</text> <paragraph num="(1)"> <text>Paid directly by the center; and</text> </paragraph> <paragraph num="(2)"> <text>At least equivalent to the prevailing salary paid by centers for an individual with similar education and experience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".45" heading="Mandated Staffing Pattern."> <paragraph num="A."> <text>When the Department determines that a deficiency or deficiencies exist, the Department shall notify the center of the deficiency or deficiencies and may either:</text> <paragraph num="(1)"> <text>Mandate a staffing pattern that specifies the number of personnel or personnel qualifications, or both; or</text> </paragraph> <paragraph num="(2)"> <text>Permit the center the opportunity to correct the deficiencies by a specific date.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the center does not correct the deficiency or deficiencies, the Department has the authority to specify the number of personnel or personnel qualifications, or both.</text> </paragraph> <paragraph num="C."> <text>The center shall comply with the Department's mandated staffing pattern and notify the Department, in writing, when the staffing pattern has been implemented.</text> </paragraph> <paragraph num="D."> <text>A mandated staffing pattern shall be in effect for the period of time specified by the Department. A center may request rescission or modification of the staffing pattern at intervals of not less than 60 days from the date of imposition of the staffing pattern.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".46" heading="Admission Restriction."> <paragraph num="A."> <text>If the Secretary determines that a serious health or fire safety deficiency exists in a center, the Secretary immediately may restrict new admissions to the center for not more than a 30-day period.</text> </paragraph> <paragraph num="B."> <text>Within 7 days after a request by an aggrieved party, a show cause hearing shall be held before the Director of the Office of Health Care Quality to show cause why the admission restriction was not appropriately imposed.</text> </paragraph> <paragraph num="C."> <text>Within 21 days after admissions are restricted, the center shall take steps to correct the deficiency.</text> </paragraph> <paragraph num="D."> <text>Unless the Secretary lifts the admissions restriction, within 30 days after admissions are restricted, a hearing shall be held to determine whether the center has taken sufficient measures to correct the deficiency.</text> </paragraph> <paragraph num="E."> <text>If the Secretary finds that the deficiency still exists, the Secretary may:</text> <paragraph num="(1)"> <text>Continue to restrict admissions for not more than three consecutive 30-day periods; or</text> </paragraph> <paragraph num="(2)"> <text>Revoke the license of the center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".47" heading="Civil Money Penalties."> <paragraph num="A."> <text>The Secretary may impose a civil money penalty if a deficiency or an ongoing pattern of deficiencies exists in a center.</text> </paragraph> <paragraph num="B."> <text>In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the participants of the center that is caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by, and the ability of, the center to correct the deficiency or deficiencies; and</text> </paragraph> <paragraph num="(5)"> <text>A center's prior history of compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the center of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Impose a per day civil money penalty until sustained compliance has been achieved;</text> </paragraph> <paragraph num="(2)"> <text>Permit the center the opportunity to correct the deficiencies by a specific date; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a per instance civil money penalty for each instance of violation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department permits a center the opportunity to correct the deficiencies by a specific date, and the center fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained.</text> </paragraph> <paragraph num="E."> <text>If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the:</text> <paragraph num="(1)"> <text>Deficiency or deficiencies on which the order is based;</text> </paragraph> <paragraph num="(2)"> <text>Amount of civil money penalties to be imposed; and</text> </paragraph> <paragraph num="(3)"> <text>Manner in which the amount of civil money penalties imposed was calculated.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An order issued pursuant to this regulation shall be void unless issued within 60 days of the inspection or re-inspection at which the deficiency is identified.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".48" heading="Amount of Civil Money Penalties."> <paragraph num="A."> <text>A civil money penalty imposed under this chapter for potential for more than minimal harm deficiencies may not exceed:</text> <paragraph num="(1)"> <text>$3,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$300 per day for an ongoing pattern of deficiencies until the center is in compliance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A civil money penalty imposed under this chapter for actual harm deficiencies may not exceed:</text> <paragraph num="(1)"> <text>$5,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$1,000 per day for an ongoing pattern of deficiencies until the center is in compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A civil money penalty imposed under this chapter for a serious and immediate threat may not exceed:</text> <paragraph num="(1)"> <text>$10,000 per instance; or</text> </paragraph> <paragraph num="(2)"> <text>$3,000 per day for an ongoing pattern of deficiencies until the center is in compliance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In setting the amount of a civil money penalty under this chapter, the Secretary shall consider the following factors:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The degree of risk to the health, life, or safety of the participants of the center caused by the deficiency or deficiencies;</text> </paragraph> <paragraph num="(3)"> <text>The efforts made by the center to correct the deficiency or deficiencies;</text> </paragraph> <paragraph num="(4)"> <text>Whether the amount of the proposed civil money penalty will jeopardize the financial ability of the center to continue operating as a center; and</text> </paragraph> <paragraph num="(5)"> <text>Other factors as justice may require.</text> </paragraph> </paragraph> <paragraph num="E."> <text>All civil money penalties collected under this chapter shall be paid into the general fund of the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".49" heading="Civil Money Penalties — Hearings."> <paragraph num="A."> <text>A hearing on the appeal shall be held in accordance with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".50" heading="Civil Penalties — Unlicensed Center."> <paragraph num="A."> <text>Imposition of Penalty. The Secretary may impose a civil money penalty on a person who manages or operates an unlicensed center as follows:</text> <paragraph num="(1)"> <text>A civil money penalty imposed on a person under this chapter may not exceed $10,000 for each offense; and</text> </paragraph> <paragraph num="(2)"> <text>When a civil money penalty is imposed, the Secretary shall issue an order which includes the:</text> <paragraph num="(a)"> <text>Deficiency or deficiencies on which the order is based;</text> </paragraph> <paragraph num="(b)"> <text>Amount of civil money penalty to be imposed; and</text> </paragraph> <paragraph num="(c)"> <text>Manner in which the amount of civil money penalty was calculated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".51" heading="Emergency Suspension."> <paragraph num="A."> <text>The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Department shall deliver a written notice to the center:</text> <paragraph num="(1)"> <text>Informing it of the emergency suspension;</text> </paragraph> <paragraph num="(2)"> <text>Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notifying the center of its right to request a hearing and to be represented by counsel.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The filing of a hearing request does not stay the emergency action.</text> </paragraph> <paragraph num="D."> <text>When a license is suspended by emergency action:</text> <paragraph num="(1)"> <text>The center shall immediately return the license to the Department;</text> </paragraph> <paragraph num="(2)"> <text>The center shall stop providing adult day care services immediately; and</text> </paragraph> <paragraph num="(3)"> <text>The licensee shall notify the participants or representatives of the participants of the suspension and make every reasonable effort to assist them in making other arrangements for adult day care services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Show Cause Hearing. In addition to the right to request a hearing in accordance with Regulation .53 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension.</text> </paragraph> <paragraph num="G."> <text>If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension. The time limit for filing an appeal with the Office of Administrative Hearings to obtain an evidentiary hearing shall be tolled by the filing of a request for a show cause hearing.</text> </paragraph> <paragraph num="H."> <text>The show cause hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension.</text> </paragraph> <paragraph num="I."> <text>The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who:</text> <paragraph num="(1)"> <text>Shall determine procedural issues;</text> </paragraph> <paragraph num="(2)"> <text>May impose reasonable time limits on each party's oral argument; and</text> </paragraph> <paragraph num="(3)"> <text>Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> <paragraph num="J."> <text>At the conclusion of the show cause hearing, the Secretary or the Secretary's designee may:</text> <paragraph num="(1)"> <text>Affirm the order of summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(4)"> <text>Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="K."> <text>After the show cause hearing, if the Secretary or the Secretary's designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings in accordance with Regulation .53 of this chapter.</text> </paragraph> <paragraph num="L."> <text>The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .53 of this chapter and issue a proposed decision within the time frames set forth in COMAR 28.02.01. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03.</text> </paragraph> <paragraph num="M."> <text>If the Secretary's final decision does not uphold the emergency suspension, the center may resume operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".52" heading="Denial or Revocation of License."> <paragraph num="A."> <text>Denial or Revocation of License. The Secretary, for cause shown, shall notify the center of its decision to deny or revoke the center's license. The denial or revocation shall be stayed if a hearing is requested.</text> </paragraph> <paragraph num="B."> <text>The Department shall notify the center in writing of the following:</text> <paragraph num="(1)"> <text>The effective date of the denial or revocation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the denial or revocation;</text> </paragraph> <paragraph num="(3)"> <text>The regulations with which the licensee has failed to comply that form the basis for the denial or revocation;</text> </paragraph> <paragraph num="(4)"> <text>That the center is entitled to a hearing if requested, and to be represented by counsel;</text> </paragraph> <paragraph num="(5)"> <text>That the center shall stop providing services on the effective date of the denial or revocation if the center does not request a hearing;</text> </paragraph> <paragraph num="(6)"> <text>That the denial or revocation shall be stayed if a hearing is requested; and</text> </paragraph> <paragraph num="(7)"> <text>That the center is required to surrender its license to the Department if the denial or revocation is upheld.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensee shall notify the participants or participants' representatives of any final denial or revocation and make every reasonable effort to assist them in making other arrangements for adult day care.</text> </paragraph> <paragraph num="D."> <text>A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".53" heading="Hearings."> <paragraph num="A."> <text>A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action.</text> </paragraph> <paragraph num="B."> <text>A hearing requested under this chapter shall be conducted in accordance with:</text> <paragraph num="(1)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burden of proof is as provided in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="D."> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>The aggrieved person may file exceptions as provided in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="F."> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 14-206, and 14-304; State Government Article, §10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 12, 1979 (6:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01; .02B, E; .03A, C, D; .04A—E; .05A, G, H, L, M, N; .06A; .07A, C; .08B; .09C; and .11B, K amended effective July 11, 1980 (7:14 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F repealed effective July 11, 1980 (7:14 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.26.01 to COMAR 10.12.04 and Regulations .01, .02A, .04—.08, .09C, .10A, and .11A amended effective November 13, 1989 (16:22 Md. R. 2365)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective July 5, 1993 (20:13 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new Regulations .01—.52 adopted effective November 23, 2006 (33:23 Md. R. 1795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.52 repealed and new Regulations .01—.53 adopted effective December 13, 2014 (41:12 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 21, 2015 (42:25 Md. R. 1543); August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="05" heading="Breast Implantation"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Breast implantation” means both:</text> <paragraph num="(a)"> <text>Breast augmentation, the procedure of surgically inserting breast implants beneath a woman's natural breasts; and</text> </paragraph> <paragraph num="(b)"> <text>The type of breast reconstruction that involves surgically inserting a breast implant in the chest area of a woman who has had a mastectomy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Physician” means an individual who is authorized under the Medical Practice Act to practice medicine in Maryland and who performs breast implantation surgery in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for the Maryland Department of Health."> <text>The Department shall:</text> <paragraph num="A."> <text>Provide a standardized written summary in layperson's language that:</text> <paragraph num="(1)"> <text>Contains the information on breast implantation generally contained in the package inserts for breast implants, and</text> </paragraph> <paragraph num="(2)"> <text>Discloses side effects, warnings, and cautions for a breast implantation operation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Update as necessary the standardized written summary;</text> </paragraph> <paragraph num="C."> <text>Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient;</text> </paragraph> <paragraph num="D."> <text>Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and</text> </paragraph> <paragraph num="E."> <text>Distribute copies of the standardized written summary, the acknowledgment of receipt statement, and the 5-day waiver form to all hospitals, clinics, other facilities, and physicians' offices where breast implantation is performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Physicians."> <paragraph num="A."> <text>The standardized written summary provided by the Department shall be provided to the woman by the physician as soon as possible but not later than 5 days before a physician performs a breast implantation operation.</text> </paragraph> <paragraph num="B."> <text>The physician may provide the standardized written summary less than 5 days before performing breast reconstruction with breast implants only when the following conditions have been met:</text> <paragraph num="(1)"> <text>The woman's breast cancer surgery is scheduled to take place within 5 days of the time she initially consults with a breast cancer surgeon;</text> </paragraph> <paragraph num="(2)"> <text>The woman decides to have breast implant reconstruction at the same time as the breast cancer surgery;</text> </paragraph> <paragraph num="(3)"> <text>At the time of the woman's initial visit with the physician who will perform the breast implant reconstruction, that physician:</text> <paragraph num="(a)"> <text>Gives the woman the Department's standardized written summary;</text> </paragraph> <paragraph num="(b)"> <text>Has the patient sign the statement provided by the Department acknowledging receipt of the summary; and</text> </paragraph> <paragraph num="(c)"> <text>Informs the woman of the relative advantages and disadvantages of having breast implant reconstruction at the same time as cancer treatment;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The woman decides to waive the 5-day minimum waiting period and signs the waiver provided by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>A copy of this signed waiver, along with a copy of the signed acknowledgment of receipt form, is placed in the patient's medical record which is used by the physician.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A physician may not perform breast implantation until a patient has been given the standardized written summary described in Regulation .02A of this chapter.</text> </paragraph> <paragraph num="D."> <text>A physician who provides a patient with the written summary required under these regulations shall have:</text> <paragraph num="(1)"> <text>The patient sign a statement provided by the Department acknowledging receipt of the summary; and</text> </paragraph> <paragraph num="(2)"> <text>A copy of the signed acknowledgment pursuant to §D(1), of this regulation, placed in the patient's medical record which is used by the physician.</text> </paragraph> </paragraph> <paragraph num="E."> <text>This regulation is supplemental and additional to any other requirements established by other laws upon a physician and may not be regarded as in derogation or substitution of any requirements now existing upon a physician, such as the need to obtain informed consent for treatment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-114, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 3, 1990 (17:17 Md. R. 2080)</annotation> </annotations> </chapter> </subtitle> <subtitle num="13" heading="Drugs"> <chapter num="01" heading="Dispensing of Prescription Drugs by a Licensee"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines the parameters under which a licensee may dispense prescription drugs in accordance with Health Occupations Article, §12-102, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Dental Examiners, the Board of Physicians, or the Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(2)"> <text>Final Check.</text> <paragraph num="(a)"> <text>“Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient.</text> </paragraph> <paragraph num="(b)"> <text>“Final check” includes the assumption of responsibility for the filled prescription, including verifying the:</text> <paragraph num="(i)"> <text>Appropriateness of the dose;</text> </paragraph> <paragraph num="(ii)"> <text>Accurate expiration date;</text> </paragraph> <paragraph num="(iii)"> <text>Accuracy of the drug dispensed;</text> </paragraph> <paragraph num="(iv)"> <text>Strength of the drug dispensed;</text> </paragraph> <paragraph num="(v)"> <text>Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(vi)"> <text>Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Licensee” means the dentist, physician, or podiatrist who is licensed by the appropriate Board to practice in Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Personally preparing and dispensing” means the licensed dentist, physician, or podiatrist:</text> <paragraph num="(a)"> <text>Is physically present on the premises where the prescription is filled; and</text> </paragraph> <paragraph num="(b)"> <text>Performs a final check of the prescription before it is dispensed to the patient.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Public interest” means the dispensing of prescription drugs by a licensee to a patient when a pharmacy is not conveniently available to the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Dispensing Permit."> <paragraph num="A."> <text>The licensee shall complete an application on a form approved by the appropriate Board and pay a fee in accordance with the fee schedule for:</text> <paragraph num="(1)"> <text>Physicians at COMAR 10.32.01.12;</text> </paragraph> <paragraph num="(2)"> <text>Podiatrists at COMAR 10.40.03; or</text> </paragraph> <paragraph num="(3)"> <text>Dentists at COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The application shall require the following information to indicate that the applicant is personally preparing and dispensing prescription drugs in the public interest:</text> <paragraph num="(1)"> <text>The name, address, and license number of the applicant;</text> </paragraph> <paragraph num="(2)"> <text>An attestation by the applicant that the applicant shall comply with the:</text> <paragraph num="(a)"> <text>Dispensing requirements set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Inspection requirements set forth in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Statutes and regulations governing dispensing of prescription drugs set forth in Health Occupations Article, Title 12, Annotated Code of Maryland, COMAR 10.19.03, and COMAR 10.34; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The address of each practice location where the applicant dispenses prescription drugs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each permit issued to a licensee expires 5 years after its date of issuance and is renewable upon timely submission of a renewal application in accordance with the requirements set forth in this regulation. The fee schedule set forth in §A of this regulation applies to all renewal applications.</text> </paragraph> <paragraph num="D."> <text>Continuing Education Requirement.</text> <paragraph num="(1)"> <text>A permit holder shall complete 10 continuing education credits over a 5-year period relating to the preparing and dispensing of prescription drugs as a condition of permit renewal.</text> </paragraph> <paragraph num="(2)"> <text>The continuing education credit requirement shall be implemented in accordance with Ch. 267, §2, Acts of 2012.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A permit issued to a licensee shall be nontransferable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Dispensing Requirements."> <paragraph num="A."> <text>A licensee shall submit an application to the appropriate Board on the form that the Board requires.</text> </paragraph> <paragraph num="B."> <text>A licensee may not dispense prescription drugs until a written permit is received from the appropriate Board, except that a written permit is not required in order to dispense starter dosages or samples provided without charge.</text> </paragraph> <paragraph num="C."> <text>A licensee shall personally prepare and dispense prescription drugs.</text> </paragraph> <paragraph num="D."> <text>Except as provided in Health Occupations Article, §12-102(c)(2)(iii), Annotated Code of Maryland, and §S of this regulation, a licensee shall dispense prescription drugs only to the patients of the licensee.</text> </paragraph> <paragraph num="E."> <text>A licensee shall comply with the labeling requirements set forth in Health Occupations Article, §12-505, Annotated Code of Maryland.</text> </paragraph> <paragraph num="F."> <text>A licensee shall comply with the child resistant packaging requirements set forth in Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>A licensee shall comply with drug recalls.</text> </paragraph> <paragraph num="H."> <text>A licensee shall record the dispensing of the prescription drug on the patient's chart.</text> </paragraph> <paragraph num="I."> <text>A licensee may not have a substantial financial interest in a pharmacy.</text> </paragraph> <paragraph num="J."> <text>A licensee shall, except for starter dosages or samples provided without charge, provide the patient with a written prescription.</text> </paragraph> <paragraph num="K."> <text>A licensee shall maintain for at least 5 years:</text> <paragraph num="(1)"> <text>A separate file for Schedule II prescriptions; and</text> </paragraph> <paragraph num="(2)"> <text>Another file for other prescriptions.</text> </paragraph> </paragraph> <paragraph num="L."> <text>A licensee shall maintain biennial inventories of all stocks of controlled substances.</text> </paragraph> <paragraph num="M."> <text>A licensee shall dispense prescription drugs to a patient only when the patient determines that a pharmacy is not conveniently available to the patient.</text> </paragraph> <paragraph num="N."> <text>In each patient’s chart for each patient to whom prescription drugs are dispensed or in a format readily retrievable, a licensee shall maintain a single form which:</text> <paragraph num="(1)"> <text>Indicates that a pharmacy is not conveniently available to the patient;</text> </paragraph> <paragraph num="(2)"> <text>States that the determination that a pharmacy is not conveniently available was made solely by the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Is signed and dated by the patient before dispensing prescription drugs to the patient for the first time.</text> </paragraph> </paragraph> <paragraph num="O."> <text>A licensee shall display prominently a sign which informs the patient that prescription drugs can be purchased from the permit holder if the patient determines that a pharmacy is not conveniently available to the patient.</text> </paragraph> <paragraph num="P."> <text>A licensee may not make any agreement that denies a patient a free choice of pharmacist or pharmacy services.</text> </paragraph> <paragraph num="Q."> <text>A licensee shall post a sign conspicuously positioned and readable regarding the process for resolving incorrectly filled prescriptions or includes written information regarding the process with each prescription dispensed.</text> </paragraph> <paragraph num="R."> <text>A licensee shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary to prepare and dispense prescriptions properly.</text> </paragraph> <paragraph num="S."> <text>To the extent permitted by COMAR 10.32.23, a licensed physician may personally prepare and dispense a prescription written by:</text> <paragraph num="(1)"> <text>A physician assistant with whom the physician has a delegation agreement that:</text> <paragraph num="(a)"> <text>Complies with Health Occupations Article, Title 15, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Permits the physician assistant to prescribe the drug; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A certified registered nurse practitioner who is:</text> <paragraph num="(a)"> <text>Authorized to practice under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Working with the physician in the same practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspection Requirements."> <paragraph num="A."> <text>The Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners shall report annually to the Office of Controlled Substances Administration the names and addresses of its licensees who:</text> <paragraph num="(1)"> <text>Are authorized to personally prepare and dispense prescription drugs; and</text> </paragraph> <paragraph num="(2)"> <text>Have reported to the appropriate Board that they have personally prepared and dispensed prescription drugs within the previous year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall allow the Office of Controlled Substances Administration to enter and inspect the licensee’s practice locations at all reasonable hours.</text> </paragraph> <paragraph num="C."> <text>The Office of Controlled Substances Administration shall:</text> <paragraph num="(1)"> <text>Enter and inspect the practice locations of a licensee who holds an initial dispensing permit:</text> <paragraph num="(a)"> <text>Within 6 months after receiving the annual report set forth in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>At least one more time during the duration of the permit;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a licensee who holds an initial dispensing permit has more than one practice location:</text> <paragraph num="(a)"> <text>Enter and inspect a practice location of the licensee within 6 months after receiving the annual report set forth in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Enter and inspect a different practice location at least one time during the duration of the permit;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a licensee who holds a dispensing permit is seeking renewal:</text> <paragraph num="(a)"> <text>Enter and inspect a practice location of a licensee at least two times during the duration of the permit; and</text> </paragraph> <paragraph num="(b)"> <text>If licensee has more than one practice location, enter and inspect two different practice locations during the duration of the permit;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Office of Controlled Substances Administration finds a deficiency at one practice location of a licensee with multiple practice locations, require the licensee to prepare, sign, and submit an affidavit attesting that all practice locations are in or will be in compliance as a result of the inspection;</text> </paragraph> <paragraph num="(5)"> <text>Report to the Board of Pharmacy a wholesale distributor not licensed in Maryland; and</text> </paragraph> <paragraph num="(6)"> <text>Report the results of the inspections required under §C(1) and (2) of this regulation to the respective board of licensure.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee shall sign and date an inspection form provided by the Office of Controlled Substances Administration relating to the requirements set forth in Health Occupations Article, §12-102, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>A licensee shall pay a fee in an amount that will produce funds to approximate, but not exceed, the documented costs to the Office of Controlled Substances Administration for inspections, as required by the appropriate Board.</text> </paragraph> <paragraph num="F."> <text>The Office of Controlled Substances Administration:</text> <paragraph num="(1)"> <text>May suspend inspections of any physician who reports pursuant to Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, that the physician has not personally dispensed any prescription medications during the preceding year; and</text> </paragraph> <paragraph num="(2)"> <text>To the extent otherwise required by this regulation, shall resume inspections if that physician later reports that the physician has resumed dispensing activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Failure to Comply with Dispensing Requirements."> <text>A licensee who fails to comply with the requirements governing dispensing of prescription drugs shall have the dispensing permit revoked and be subject to disciplinary action by the appropriate licensing board.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-102 and 12-102.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 19, 1935</annotation> <annotation type="History" subtype="Administrative History">Chapter, Permits for Sale of Poisons by General Merchants, repealed effective July 10, 1989 (16:13 Md. R. 1421)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Dispensing of Prescription Drugs by a Licensee, adopted effective May 11, 1992 (19:9 Md. R. 879)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 6, 2000 (27:4 Md. R. 453)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 22, 2015 (42:12 Md. R. 762)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, N amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04S adopted effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> </annotations> </chapter> <chapter num="02" heading="Purchase and Distribution of Prescription Drugs and Devices"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the purchasing and distribution of prescription drugs and devices by the Department for public health purposes.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adulterated” means a drug or device where:</text> <paragraph num="(a)"> <text>Any part of the drug or device is filthy, putrid, or a decomposed substance; or</text> </paragraph> <paragraph num="(b)"> <text>The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:</text> <paragraph num="(i)"> <text>Contaminated the drug or device with filth; or</text> </paragraph> <paragraph num="(ii)"> <text>Caused the drug or device to be injurious to health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Misbranded” means a drug or device where:</text> <paragraph num="(a)"> <text>The drug’s or device’s:</text> <paragraph num="(i)"> <text>Labeling is false or misleading in any way; or</text> </paragraph> <paragraph num="(ii)"> <text>Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;</text> </paragraph> <paragraph num="(c)"> <text>Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug’s or device’s labeling is not placed prominently on the labeling in a manner that is:</text> <paragraph num="(i)"> <text>Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and</text> </paragraph> <paragraph num="(ii)"> <text>In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device;</text> </paragraph> <paragraph num="(e)"> <text>The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against:</text> <paragraph num="(i)"> <text>The use of the drug or device by anyone suffering from a pathological condition that may cause the drug’s or device’s use to be dangerous to health;</text> </paragraph> <paragraph num="(ii)"> <text>The use of the drug or device by a child if the use by a child may be dangerous; and</text> </paragraph> <paragraph num="(iii)"> <text>Unsafe dosages, methods of administration, or duration of administration of the drug or device;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The drug or device is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or</text> </paragraph> <paragraph num="(g)"> <text>The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Pedigree” means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer.</text> </paragraph> <paragraph num="(6)"> <text>“Prescription device” means a device required by federal law or regulation to be dispensed only by a prescription.</text> </paragraph> <paragraph num="(7)"> <text>Prescription Drug.</text> <paragraph num="(a)"> <text>“Prescription drug” means a drug required by federal law or regulation to be dispensed only by a prescription.</text> </paragraph> <paragraph num="(b)"> <text>“Prescription drug” includes:</text> <paragraph num="(i)"> <text>A biological product; and</text> </paragraph> <paragraph num="(ii)"> <text>Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug, and Cosmetic Act.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Prescription drug” does not include:</text> <paragraph num="(i)"> <text>Blood and blood components intended for transfusion; or</text> </paragraph> <paragraph num="(ii)"> <text>Biological products that are also medical devices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Public health purposes” includes the purpose of controlling communicable diseases or environmental health hazards.</text> </paragraph> <paragraph num="(9)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Personnel."> <paragraph num="A."> <text>The Secretary shall designate one or more Department employee representatives to be responsible for the purchase and distribution of prescription drugs and devices for public health purposes.</text> </paragraph> <paragraph num="B."> <text>A designated Department representative shall:</text> <paragraph num="(1)"> <text>Be a merit or contractual employee of the Department employed full time in a managerial level position;</text> </paragraph> <paragraph num="(2)"> <text>Be aware of and knowledgeable about the policies and procedures pertaining to the purchase and distribution of prescription drugs and devices for public health purposes, including applicable State and federal laws;</text> </paragraph> <paragraph num="(3)"> <text>Be actively involved in, and aware of, the daily operation of the Department’s purchasing and distribution of prescription drugs and prescription devices;</text> </paragraph> <paragraph num="(4)"> <text>Be responsible for:</text> <paragraph num="(a)"> <text>Storage and handling as set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Record-keeping requirements as set forth in Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Making records available for inspection; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Meet the following qualifications:</text> <paragraph num="(a)"> <text>Is 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Except for an authorized absence such as sick leave or vacation leave, is physically present at the Department during regular business hours;</text> </paragraph> <paragraph num="(c)"> <text>Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and</text> </paragraph> <paragraph num="(d)"> <text>Does not have any convictions for a felony under federal, State, or local laws.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Storage and Handling."> <paragraph num="A."> <text>Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that:</text> <paragraph num="(1)"> <text>Is constructed to facilitate:</text> <paragraph num="(a)"> <text>Cleaning; and</text> </paragraph> <paragraph num="(b)"> <text>Maintenance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has storage areas designed to provide adequate:</text> <paragraph num="(a)"> <text>Equipment;</text> </paragraph> <paragraph num="(b)"> <text>Humidity control;</text> </paragraph> <paragraph num="(c)"> <text>Lighting;</text> </paragraph> <paragraph num="(d)"> <text>Sanitation;</text> </paragraph> <paragraph num="(e)"> <text>Security conditions;</text> </paragraph> <paragraph num="(f)"> <text>Space;</text> </paragraph> <paragraph num="(g)"> <text>Temperature; and</text> </paragraph> <paragraph num="(h)"> <text>Ventilation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Has a secured separate quarantine area for storage of prescription drugs or devices that are:</text> <paragraph num="(a)"> <text>Adulterated;</text> </paragraph> <paragraph num="(b)"> <text>Damaged;</text> </paragraph> <paragraph num="(c)"> <text>Deteriorated;</text> </paragraph> <paragraph num="(d)"> <text>In immediate or sealed secondary containers that have been opened;</text> </paragraph> <paragraph num="(e)"> <text>Misbranded; or</text> </paragraph> <paragraph num="(f)"> <text>Outdated;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is maintained in a clean and orderly condition; and</text> </paragraph> <paragraph num="(5)"> <text>Is free from insects, rodents, birds, or vermin.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Storage.</text> <paragraph num="(1)"> <text>A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:</text> <paragraph num="(a)"> <text>If any, on the labeling of the prescription drug or device; or</text> </paragraph> <paragraph num="(b)"> <text>Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.</text> </paragraph> <paragraph num="(3)"> <text>A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the:</text> <paragraph num="(a)"> <text>Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and</text> </paragraph> <paragraph num="(b)"> <text>Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Examination of Materials.</text> <paragraph num="(1)"> <text>Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of:</text> <paragraph num="(a)"> <text>An adulterated prescription drug or device; or</text> </paragraph> <paragraph num="(b)"> <text>A prescription drug or device that is otherwise unfit for distribution.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents.</text> </paragraph> <paragraph num="(3)"> <text>A designated Department representative shall carefully inspect each outgoing shipment:</text> <paragraph num="(a)"> <text>For identity of the prescription drug or device being shipped; and</text> </paragraph> <paragraph num="(b)"> <text>To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping.</text> </paragraph> <paragraph num="(5)"> <text>A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows:</text> <paragraph num="(1)"> <text>Access from outside the premises is:</text> <paragraph num="(a)"> <text>Kept to a minimum; and</text> </paragraph> <paragraph num="(b)"> <text>Limited to authorized personnel as determined by the designated Department representative; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The storage area is equipped with:</text> <paragraph num="(a)"> <text>A security system that provides protection against theft and diversion;</text> </paragraph> <paragraph num="(b)"> <text>An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and</text> </paragraph> <paragraph num="(c)"> <text>A security system that protects the integrity and confidentiality of data and documents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored:</text> <paragraph num="(1)"> <text>Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and</text> </paragraph> <paragraph num="(2)"> <text>Allows for inspection by a Board representative.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quarantine, Destruction, and Return of Prescription Drugs and Devices."> <paragraph num="A."> <text>A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices are destroyed or returned to their supplier for disposal.</text> </paragraph> <paragraph num="B."> <text>A designated Department representative shall identify, mark, quarantine, and physically separate from other prescription drugs and devices those prescription drugs and devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the prescription drugs and devices are either destroyed or returned to their supplier for disposal.</text> </paragraph> <paragraph num="C."> <text>Prescription Drugs.</text> <paragraph num="(1)"> <text>If the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then a designated Department representative shall destroy the prescription drug or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity.</text> </paragraph> <paragraph num="(2)"> <text>In determining whether the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, a designated Department representative shall consider, at a minimum, the:</text> <paragraph num="(a)"> <text>Conditions under which the prescription drug has been held, stored, or shipped before or during the return of the prescription drug; and</text> </paragraph> <paragraph num="(b)"> <text>Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Prescription Devices.</text> <paragraph num="(1)"> <text>If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then a designated Department representative shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality.</text> </paragraph> <paragraph num="(2)"> <text>In determining whether the conditions under which a prescription device has been returned by a local health department or a health care provider cast doubt on the prescription device's safety, identity, or quality, a designated Department representative shall consider, at a minimum, the:</text> <paragraph num="(a)"> <text>Conditions under which the prescription device has been held, stored, or shipped before or during return of the prescription device; and</text> </paragraph> <paragraph num="(b)"> <text>Condition of the prescription device and the device’s container, carton, or labeling, as a result of storage or shipping.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and devices.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Record Keeping."> <text>A designated Department representative shall:</text> <paragraph num="A."> <text>Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices;</text> </paragraph> <paragraph num="B."> <text>Include the following information in the records required under §A of this regulation:</text> <paragraph num="(1)"> <text>The source of a prescription drug or device, including the:</text> <paragraph num="(a)"> <text>Name and principal address of the seller or transferor; and</text> </paragraph> <paragraph num="(b)"> <text>Address of the location from which a prescription drug or device was shipped;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The identity and quantity of the prescription drugs and devices received and distributed or disposed of;</text> </paragraph> <paragraph num="(3)"> <text>The dates of receipt and distribution or other disposition of the prescription drugs and devices; and</text> </paragraph> <paragraph num="(4)"> <text>If required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, the pedigrees for prescription drugs that are wholesale distributed outside the normal distribution channel;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Establish, maintain, and adhere to written policies and procedures addressing the:</text> <paragraph num="(1)"> <text>Receipt, security, storage, inventory, and distribution of prescription drugs and devices;</text> </paragraph> <paragraph num="(2)"> <text>Identifying, recording, and reporting of losses or thefts; and</text> </paragraph> <paragraph num="(3)"> <text>Correcting of errors and inaccuracies in inventories;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Include in the written policies and procedures established according to §C of this regulation the following:</text> <paragraph num="(1)"> <text>A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first;</text> </paragraph> <paragraph num="(2)"> <text>Procedures to be followed for handling a recall and withdrawal of a prescription drug or device due to:</text> <paragraph num="(a)"> <text>An action initiated at the request of the United States Food and Drug Administration (FDA) or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control;</text> </paragraph> <paragraph num="(b)"> <text>A voluntary action by the manufacturer to remove a defective or potentially defective prescription drug or device from the market; and</text> </paragraph> <paragraph num="(c)"> <text>An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A procedure to ensure that the Department is prepared for, protected against, and able to handle a crisis that affects security or operation of a facility if any of the following situations occur:</text> <paragraph num="(a)"> <text>Strike;</text> </paragraph> <paragraph num="(b)"> <text>Fire;</text> </paragraph> <paragraph num="(c)"> <text>Flood;</text> </paragraph> <paragraph num="(d)"> <text>Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Terrorist activities;</text> </paragraph> <paragraph num="(f)"> <text>Natural disaster; or</text> </paragraph> <paragraph num="(g)"> <text>Other situations of local, State, or national emergency;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A procedure to ensure that outdated prescription drugs and devices are segregated from other prescription drugs and devices and either returned to the manufacturer or destroyed;</text> </paragraph> <paragraph num="(5)"> <text>A procedure for:</text> <paragraph num="(a)"> <text>The disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities; and</text> </paragraph> <paragraph num="(b)"> <text>Appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A procedure for:</text> <paragraph num="(a)"> <text>Identifying, investigating, and reporting prescription drug inventory discrepancies involving counterfeiting, suspicion of counterfeiting, contraband, or suspicion of contraband; and</text> </paragraph> <paragraph num="(b)"> <text>Upon discovery, the reporting of a discrepancy within 5 business days to the Board;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Make available inventories and records for inspection and copying by authorized federal or State law enforcement agency officials for a period of 3 years after the date of creation of the inventories and records;</text> </paragraph> <paragraph num="F."> <text>Keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either:</text> <paragraph num="(1)"> <text>At the inspection site; or</text> </paragraph> <paragraph num="(2)"> <text>So as to be immediately retrievable by computer or other electronic means;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable;</text> </paragraph> <paragraph num="H."> <text>Establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA;</text> </paragraph> <paragraph num="I."> <text>Maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to:</text> <paragraph num="(1)"> <text>The Board;</text> </paragraph> <paragraph num="(2)"> <text>The FDA; and</text> </paragraph> <paragraph num="(3)"> <text>Where applicable, the U.S. Drug Enforcement Administration; and</text> </paragraph> </paragraph> <paragraph num="J."> <text>Consider the following factors when determining if there has been a significant inventory loss:</text> <paragraph num="(1)"> <text>The schedule of the missing items;</text> </paragraph> <paragraph num="(2)"> <text>The abuse or misuse potential of the missing items;</text> </paragraph> <paragraph num="(3)"> <text>The abuse or misuse potential in the Department’s area of the missing substance;</text> </paragraph> <paragraph num="(4)"> <text>The quantity missing in relation to the total quantity purchased, for example, one tablet per</text> </paragraph> <paragraph num="(5)"> <text>Whether this is the first time a potentially significant inventory loss has occurred;</text> </paragraph> <paragraph num="(6)"> <text>Whether this loss was reported to local law enforcement authorities; and</text> </paragraph> <paragraph num="(7)"> <text>Whether there is a significant resale value of the missing items.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §21-234; Health Occupations Article, §§12-6C-01(u) and 12-6C-03.1; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 22, 2011 (38:17 Md. R. 1012)</annotation> </annotations> </chapter> <chapter num="03" heading="Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all licensed health care practitioners who may prescribe an opioid overdose reversal drug to an individual who:</text> <paragraph num="A."> <text>May be at an elevated risk of experiencing an opioid overdose including, but not limited to, an individual who:</text> <paragraph num="(1)"> <text>Is receiving an opioid for chronic pain;</text> </paragraph> <paragraph num="(2)"> <text>Is receiving an opioid and a prescription for a benzodiazepine; or</text> </paragraph> <paragraph num="(3)"> <text>Has an opioid use disorder; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>Resides or spends time with an individual who:</text> <paragraph num="(1)"> <text>Is prescribed opioids;</text> </paragraph> <paragraph num="(2)"> <text>Misuses opioids; or</text> </paragraph> <paragraph num="(3)"> <text>Has an opioid use disorder.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Co–prescribed” means, with respect to an opioid overdose reversal drug, the practice of prescribing the drug in conjunction with an opioid prescription for a patient at an elevated risk of overdose.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Opioid overdose reversal drug” means a drug that:</text> <paragraph num="(a)"> <text>Rapidly reverses the respiratory depressant effects of an opioid medication; and</text> </paragraph> <paragraph num="(b)"> <text>Is approved by the federal Food and Drug Administration for the treatment of a known or suspected opioid overdose.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Prescribing licensed health care provider” means an individual who is authorized by law to prescribe a monitored prescription drug.</text> </paragraph> <paragraph num="(6)"> <text>“Risk factor” means a characteristic, condition, behavior, or any variable that increases the likelihood of developing a disease or injury.</text> </paragraph> <paragraph num="(7)"> <text>“Secretary” means the Secretary of the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>Targeted Patient Population.</text> <paragraph num="(a)"> <text>“Targeted patient population” means an individual likely to experience or witness an opioid overdose.</text> </paragraph> <paragraph num="(b)"> <text>“Targeted patient population” includes, but is not limited to, an individual who:</text> <paragraph num="(i)"> <text>Is being prescribed opioids for acute, if appropriate, or chronic pain;</text> </paragraph> <paragraph num="(ii)"> <text>Is being treated for an opioid use disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Is receiving a prescription for an opioid and a benzodiazepine; or</text> </paragraph> <paragraph num="(iv)"> <text>Resides or spends time with an individual who is prescribed opioids, misuses opioids, or has an opioid use disorder.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Provisions."> <paragraph num="A."> <text>When determined appropriate by the prescribing licensed health care provider, targeted patient populations may be co-prescribed an opioid overdose reversal drug, if the individual is at an elevated risk of experiencing an opioid overdose by virtue of belonging to one or more categories of the targeted patient population.</text> </paragraph> <paragraph num="B."> <text>Responsibilities of the Prescribing Licensed Health Care Provider.</text> <paragraph num="(1)"> <text>Risk Monitoring.</text> <paragraph num="(a)"> <text>It is suggested that the licensed health care provider routinely assess patients for their risk of being likely to experience or witness an opioid overdose.</text> </paragraph> <paragraph num="(b)"> <text>The prescriber may utilize additional sources of information for determining a patient’s opioid overdose risk including, but not limited to:</text> <paragraph num="(i)"> <text>Checking the Maryland Prescription Drug Monitoring Program;</text> </paragraph> <paragraph num="(ii)"> <text>Reviewing medical records; and</text> </paragraph> <paragraph num="(iii)"> <text>Soliciting family input, if appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Education. If a patient is assessed to be at risk of an opioid overdose, the prescriber may educate the patient about, including but not limited to, the following areas:</text> <paragraph num="(a)"> <text>The risks of an opioid overdose; and</text> </paragraph> <paragraph num="(b)"> <text>How to identify and respond to an opioid overdose.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation. Licensed health care providers should document education and clinical services related to the provision of an opioid overdose reversal drug in their patients’ medical records in accordance with the standard of care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Additional Guidelines."> <text>The Secretary may make the following additional clinical guidance available on the Department’s website:</text> <paragraph num="A."> <text>Any available opioid overdose reversal drug formulations, corresponding prescribing templates, and any standing order for these drugs; and</text> </paragraph> <paragraph num="B."> <text>Any other applicable information deemed necessary by the Secretary.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 13-3501, and 13-3502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 17, 2019 (46:12 Md. R. 544)</annotation> </annotations> </chapter> <chapter num="04" heading="Emergency Use Epinephrine Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to employees of food service, recreation, or wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland, and employees of food service facilities, as defined in COMAR 10.15.03, who voluntarily participate in the Program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by a participating facility to serve either as a health supervisor or as a certificate holder.</text> </paragraph> <paragraph num="(2)"> <text>“Agent” means an individual who:</text> <paragraph num="(a)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Is designated in writing by a certificate holder to administer emergency use epinephrine in an emergency situation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Anaphylaxis” means a sudden, severe, and potentially life-threatening allergic reaction that occurs when an individual is exposed to an allergen.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means an individual applying for a Certificate for Emergency Epinephrine.</text> </paragraph> <paragraph num="(5)"> <text>“Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by a participating facility to obtain, store, and administer emergency use epinephrine.</text> </paragraph> <paragraph num="(6)"> <text>“Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer emergency use epinephrine to be used in an emergency situation.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Emergency use epinephrine” means a portable, disposable drug delivery device or product approved by the federal Food and Drug Administration that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.</text> </paragraph> <paragraph num="(10)"> <text>“Food service facility” has the meaning stated in COMAR 10.15.03.</text> </paragraph> <paragraph num="(11)"> <text>“Health supervisor” means an individual who:</text> <paragraph num="(a)"> <text>Provides health services for a participating facility; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed by the State as a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Certified nurse practitioner; or</text> </paragraph> <paragraph num="(iii)"> <text>Registered nurse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Participating facility” means a recreation or wellness facility at an eligible institution or a food service facility, including a food service facility at an eligible institution, in the State that voluntarily participates in the Program.</text> </paragraph> <paragraph num="(13)"> <text>“Successfully completed” means to pass a written examination with a grade of 75 percent or higher.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Emergency Epinephrine."> <paragraph num="A."> <text>An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:</text> <paragraph num="(1)"> <text>Is employed by a participating facility;</text> </paragraph> <paragraph num="(2)"> <text>Is 18 years old or older; and</text> </paragraph> <paragraph num="(3)"> <text>Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:</text> <paragraph num="(1)"> <text>Designation of agents and affiliated individuals;</text> </paragraph> <paragraph num="(2)"> <text>The name of the approved emergency epinephrine educational training program; and</text> </paragraph> <paragraph num="(3)"> <text>Procedures to:</text> <paragraph num="(a)"> <text>Store emergency use epinephrine;</text> </paragraph> <paragraph num="(b)"> <text>Maintain the emergency use epinephrine in a secure manner;</text> </paragraph> <paragraph num="(c)"> <text>Report use of emergency use epinephrine according to §L of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Train an emergency epinephrine certificate holder and agent annually; and</text> </paragraph> <paragraph num="(e)"> <text>Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.</text> </paragraph> <paragraph num="D."> <text>An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.</text> </paragraph> <paragraph num="E."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and</text> </paragraph> <paragraph num="(6)"> <text>On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency use epinephrine at participating facilities according to §L of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate holder.</text> </paragraph> <paragraph num="G."> <text>A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense emergency use epinephrine under a prescription issued to a certificate holder.</text> </paragraph> <paragraph num="H."> <text>A certificate holder may:</text> <paragraph num="(1)"> <text>On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for emergency use epinephrine; and</text> </paragraph> <paragraph num="(2)"> <text>Possess and store prescribed emergency use epinephrine.</text> </paragraph> </paragraph> <paragraph num="I."> <text>A participating facility:</text> <paragraph num="(1)"> <text>Shall ensure that there is a written plan for the emergency epinephrine program that:</text> <paragraph num="(a)"> <text>Is approved annually, in writing, by a health supervisor;</text> </paragraph> <paragraph num="(b)"> <text>Is on file at the participating facility and is available for inspection; and</text> </paragraph> <paragraph num="(c)"> <text>Includes at a minimum:</text> <paragraph num="(i)"> <text>The name, title, and license number of the health supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>Information on the emergency epinephrine educational training program used;</text> </paragraph> <paragraph num="(iii)"> <text>Procedures for disseminating information to staff on the emergency epinephrine program;</text> </paragraph> <paragraph num="(iv)"> <text>Procedures for the proper storage and handling of medication;</text> </paragraph> <paragraph num="(v)"> <text>Procedures for the use of emergency services and 911 services; and</text> </paragraph> <paragraph num="(vi)"> <text>Procedures for documenting incidents involving the administration of emergency use epinephrine by a certificate holder in accordance with §L of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the participating facility complies with all provisions of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Shall provide the Department with access to records and documents required under this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of emergency use epinephrine;</text> </paragraph> <paragraph num="(5)"> <text>May not obtain or store emergency use epinephrine unless the participating facility has at least two certificate holders; and</text> </paragraph> <paragraph num="(6)"> <text>Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Certificate Holders.</text> <paragraph num="(1)"> <text>Subject to §I(4) of this regulation, a certificate holder may obtain:</text> <paragraph num="(a)"> <text>A prescription for a supply of emergency use epinephrine from a licensed physician as provided in §F of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>A supply of emergency use epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A certificate holder shall store a supply of emergency use epinephrine obtained under §J(1) of this regulation:</text> <paragraph num="(a)"> <text>In accordance with the manufacturer’s instructions; and</text> </paragraph> <paragraph num="(b)"> <text>In a location that is readily accessible to certificate holders and agents in an emergency situation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.</text> </paragraph> <paragraph num="L."> <text>A participating facility shall ensure that an incident that occurred on the premises of the facility that involved the administration of emergency use epinephrine by a certificate holder or agent is reported:</text> <paragraph num="(1)"> <text>Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>To the Department within 5 business days of the incident on a form prescribed by the Department.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 12, 2021 (48:14 Md. R. 538)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)</annotation> </annotations> </chapter> <chapter num="05" heading="AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: June 17, 1955</annotation> <annotation type="History" subtype="Administrative History">Chapter “Purchase of Exempt Narcotic Preparations” repealed effective August 25, 1978 (5:17 Md. R. 1329)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 “AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes” adopted effective October 12, 1992 (19:20 Md. R. 1815)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 12, 2001 (28:1 Md. R. 26)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective March 26, 2018 (45:6 Md. R. 320)</annotation> </annotations> </chapter> <chapter num="06" heading="Acceptance of Oral Prescriptions for Certain Narcotic Drugs" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: November 10, 1955</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330)</annotation> </annotations> </chapter> <chapter num="07" heading="Sale of Dihydrocodeinone or any of its Salts" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 1, 1960</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330)</annotation> </annotations> </chapter> <chapter num="08" heading="Sale of Needles and Syringes or Other Paraphernalia"> <regulation prefix="Regulation" num=".01" heading="Identification of Purchaser, and Record of Sale."> <text>The sale of needles and syringes or other paraphernalia shall be made by the pharmacist only in good faith to patients showing proper identification and indication of need.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 21, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 6, 2000 (27:4 Md. R. 454)</annotation> </annotations> </chapter> <chapter num="09" heading="Sale of Nitrous Oxide" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: September 21, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed effective January 21, 1991 (18:1 Md. R. 29)</annotation> </annotations> </chapter> <chapter num="10" heading="Prescribing, Administering, and Dispensing of Amphetamines and Methamphetamines" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: August 7, 1973</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 13, 1979 (6:14 Md. R. 1207)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 21, 1991 (18:1 Md. R. 29)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective December 18, 1995 (22:25 Md. R. 1962)</annotation> </annotations> </chapter> <chapter num="11" heading="Sale of Drugs by Vending Machine"> <regulation prefix="Regulation" num=".01" heading="Exemption to Allow Sale of Drugs in Vending Machine."> <paragraph num="A."> <text>A person may sell by vending machine or other similar device, nonprescription drugs that alleviate pain in the quantities and form specified in §B of this regulation, and which are exempted from the prohibition of Health-General Article, §21-1111, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Nonprescription drugs that alleviate pain may be sold by vending machine or other similar devices in:</text> <paragraph num="(1)"> <text>Solid oral dosage form only; and</text> </paragraph> <paragraph num="(2)"> <text>Single dose quantities of not more than three tablets or capsules per dose.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §21-1111(c), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 10, 1994 (21:20 Md. R. 1732)</annotation> </annotations> </chapter> <chapter num="12" heading="Impoundment and Disposal of Drugs and Prescription Records"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Authorized prescriber” means:</text> <paragraph num="(a)"> <text>A licensed dentist, licensed physician, licensed podiatrist, licensed veterinarian, or to the extent permitted under Health Occupations Article, §8-601, Annotated Code of Maryland, certified nurse midwife;</text> </paragraph> <paragraph num="(b)"> <text>A certified nurse practitioner to the extent permitted under Health Occupations Article, §8-508, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Another individual authorized by law to prescribe prescription or nonprescription drugs or devices.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means a health occupation licensing board:</text> <paragraph num="(a)"> <text>Authorized to issue a permit, license, or certificate under Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>That has regulatory authority over the permit holder or authorized prescriber who is responsible for the drugs or prescription records subject to impoundment.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health, or its authorized agent.</text> </paragraph> <paragraph num="(4)"> <text>“Drug” means a prescription drug or device or a nonprescription drug, as defined in Health-General Article, §21-1113(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Impoundment order” means an order issued by the Department to impound drugs or prescription records in accordance with Health-General Article, §21-1113, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Permit holder” means a holder of, or applicant for:</text> <paragraph num="(a)"> <text>A pharmacy permit, manufacturer's permit, or distributor's permit issued by the State Board of Pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A dispensing permit issued by the board under the authority of Health Occupations Article, §12-102(c)(2), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Prescription records” means records maintained by a permit holder or authorized prescriber which identify a patient and any medical information relating to that patient.</text> </paragraph> <paragraph num="(8)"> <text>“Transfer” means the release of impounded drugs or prescription records by the department to a transferee.</text> </paragraph> <paragraph num="(9)"> <text>“Transferee” means a permit holder or authorized prescriber to whom impounded drugs or prescription records are transferred in accordance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for an Impoundment Order."> <paragraph num="A."> <text>The Department may issue an impoundment order if:</text> <paragraph num="(1)"> <text>A permit holder's permit or authorized prescriber's license has expired or has been revoked or suspended;</text> </paragraph> <paragraph num="(2)"> <text>An application for a permit or license has been denied;</text> </paragraph> <paragraph num="(3)"> <text>A board has:</text> <paragraph num="(a)"> <text>Determined that the permit holder or authorized prescriber failed to comply with a board order, letter of surrender, or law regarding the disposition of drugs or prescription records; and</text> </paragraph> <paragraph num="(b)"> <text>Requested that the Department impound the drugs or prescription records;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The drugs pose an imminent threat to the public health, safety, or welfare; or</text> </paragraph> <paragraph num="(5)"> <text>The confidentiality of the prescription records is in imminent danger of being compromised.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may issue an impoundment order based on:</text> <paragraph num="(1)"> <text>On-site observation by a law enforcement official, the Department, or other regulatory official of drugs that pose imminent danger to the public health, safety, or welfare;</text> </paragraph> <paragraph num="(2)"> <text>On-site observation by a law enforcement official, the Department, or other regulatory official that the confidentiality of prescription records is in imminent danger of being compromised;</text> </paragraph> <paragraph num="(3)"> <text>Investigation by the Department or law enforcement authority sufficient to prove that drugs are posing an imminent danger to the public health, safety, or welfare, or that the confidentiality of prescription records is in imminent danger of being compromised; or</text> </paragraph> <paragraph num="(4)"> <text>Review of the board's licensing records that indicate the permit holder or authorized prescriber does not have the licensing or permit authority to possess drugs or prescription records.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before execution of an impoundment order issued in accordance with Health-General Article, §21-1113(c)(1), Annotated Code of Maryland, the Department shall:</text> <paragraph num="(1)"> <text>Attempt to serve written notice of the impoundment on the permit holder or authorized prescriber by certified mail at the last known address in the board's licensing files; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the permit holder or authorized prescriber with an opportunity to:</text> <paragraph num="(a)"> <text>Avoid impoundment by allowing the permit holder or authorized prescriber to dispose of the drugs or prescription records in a manner acceptable to the Department;</text> </paragraph> <paragraph num="(b)"> <text>Review the nature, type, and amount of information upon which the Department issued the impoundment order; and</text> </paragraph> <paragraph num="(c)"> <text>Avoid impoundment by providing the Department with information upon which the Department could reasonably conclude that the impoundment is not warranted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notice of Order of Impoundment.</text> <paragraph num="(1)"> <text>If the Department issues an impoundment order in accordance with Health-General Article, §21-1113(c)(2), Annotated Code of Maryland, the Department shall attempt to contact the permit holder or authorized prescriber at the last known address or telephone number contained in the board's licensing files before executing the impoundment order.</text> </paragraph> <paragraph num="(2)"> <text>Posting.</text> <paragraph num="(a)"> <text>If the Department is unsuccessful in contacting the permit holder or authorized prescriber before the execution of the impoundment order, the Department shall post the impoundment order in a conspicuous place at the site of the drugs or prescription records.</text> </paragraph> <paragraph num="(b)"> <text>The posted impoundment order shall contain information regarding:</text> <paragraph num="(i)"> <text>The location of the impounded drugs or prescription records; and</text> </paragraph> <paragraph num="(ii)"> <text>An individual to contact for further information.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disposition of Impounded Drugs or Prescription Records."> <paragraph num="A."> <text>If the Department executes an impoundment order against a permit holder or authorized prescriber, the Department shall:</text> <paragraph num="(1)"> <text>Arrange for the drugs or prescription records to be kept in a secure location;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that any location which stores impounded drugs provides the necessary temperature controls and equipment to properly maintain the drugs; and</text> </paragraph> <paragraph num="(3)"> <text>Provide the permit holder or authorized prescriber with a list of all drugs and prescription records impounded.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reclamation or Transfer.</text> <paragraph num="(1)"> <text>The permit holder or authorized prescriber may petition the Department to reclaim or transfer the impounded drugs or prescription records within 30 days of the date of the impoundment order.</text> </paragraph> <paragraph num="(2)"> <text>In order to reclaim or receive a transfer of impounded drugs or prescription records, the permit holder, authorized prescriber, or transferee shall demonstrate:</text> <paragraph num="(a)"> <text>Capability to maintain the impounded drugs or prescription records in compliance with all relevant State and federal laws;</text> </paragraph> <paragraph num="(b)"> <text>Applicable licensing or permit authority to obtain possession of the impounded drugs or prescription records; and</text> </paragraph> <paragraph num="(c)"> <text>If the impounded drugs or prescription records are to be transferred to a transferee, the existence of an express written agreement between the permit holder or authorized prescriber and the transferee, permitting the Department to release the impounded drugs or prescription records to the transferee.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Department grants a petition to reclaim or transfer impounded drugs or prescription records, the petitioner shall arrange for the removal and transport of the impounded drugs or prescription records.</text> </paragraph> <paragraph num="(4)"> <text>Notice of Denial.</text> <paragraph num="(a)"> <text>If the Department denies a petition to reclaim or transfer impounded drugs or prescription records, the Department may destroy or transfer the impounded drugs or prescription records in accordance with §C(2) of this regulation at least 15 days after the Department has attempted to serve notice by certified mail at the last known address of the permit holder or authorized prescriber.</text> </paragraph> <paragraph num="(b)"> <text>The notice shall indicate that the Department:</text> <paragraph num="(i)"> <text>Has denied the petition; and</text> </paragraph> <paragraph num="(ii)"> <text>Intends to destroy or transfer the impounded drugs or prescription records.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Disposition of Drugs or Prescription Records if No Petition is Filed.</text> <paragraph num="(1)"> <text>If the permit holder or authorized prescriber has not petitioned the Department within 30 days as provided in §B of this regulation, the Department may destroy or transfer the impounded drugs or prescription records.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall destroy or transfer:</text> <paragraph num="(a)"> <text>Impounded drugs in accordance with all relevant State and federal laws, including Health-General Article, §21-1113(i), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Prescription records in accordance with Health-General Article, §§4-403 and 21-1113(i), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>The permit holder or authorized prescriber shall reimburse the Department for the reasonable expenses relating to the collection, storage, and disposition of impounded drugs or prescription records.</text> </paragraph> <paragraph num="(2)"> <text>The Department may require that the permit holder or authorized prescriber provide advance reimbursement to the Department as a precondition to granting a petition to reclaim or transfer impounded drugs or prescription records.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §21-1113, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 24, 2002 (29:12 Md. R. 927)</annotation> </annotations> </chapter> </subtitle> <subtitle num="14" heading="Cancer Control"> <chapter num="01" heading="Cancer Registry"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes a cancer registry within the Department, defines key terms, details the information to be contained in a cancer report, and specifies requirements of reporting facilities, nursing facilities, assisted living programs, and general hospice care programs. In addition, this chapter identifies requestors authorized to receive confidential data, allows a fee to be charged for data reports, and incorporates by reference the Maryland Cancer Registry Data Use Manual and Procedures (July 2016).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assisted living program” has the meaning stated in COMAR 10.07.14.02B.</text> </paragraph> <paragraph num="(2)"> <text>“Cancer registry” means a computerized system to register all cases of reportable human cancer or reportable human central nervous system (CNS) tumors of Maryland residents and nonresidents diagnosed or treated in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Cancer report” means a one-time abstract from one or more of the following documents maintained by a reporting facility, nursing facility, assisted living program, or general hospice care program of each new case of reportable human cancer or CNS tumor diagnosed or treated, and any other case of reportable human cancer or CNS tumor initially diagnosed or treated for time periods as designated by the Secretary:</text> <paragraph num="(a)"> <text>Medical record;</text> </paragraph> <paragraph num="(b)"> <text>Pathology report; and</text> </paragraph> <paragraph num="(c)"> <text>Radiological report.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Case of a Reportable Human CNS Tumor.</text> <paragraph num="(a)"> <text>“Case of a reportable human CNS tumor” means an identified human tumor, irrespective of histologic type or behavior, occurring as a primary tumor in any of the following sites or subsites with International Classification of Diseases for Oncology, Third Edition (ICD-O-3) topography codes C70.0 — C72.9 and C75.1 — C75.3:</text> <paragraph num="(i)"> <text>The brain;</text> </paragraph> <paragraph num="(ii)"> <text>The meninges;</text> </paragraph> <paragraph num="(iii)"> <text>The spinal cord;</text> </paragraph> <paragraph num="(iv)"> <text>The cauda equina;</text> </paragraph> <paragraph num="(v)"> <text>A cranial nerve;</text> </paragraph> <paragraph num="(vi)"> <text>The pituitary gland;</text> </paragraph> <paragraph num="(vii)"> <text>The pineal gland; or</text> </paragraph> <paragraph num="(viii)"> <text>The craniopharyngeal duct.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Case of a reportable human CNS tumor” includes all benign and uncertain behavior tumors of the CNS (ICD-10-CM Codes D18.02, D32.0 — D33.9, D35.2 — D35.4, D42.0 — D43.9, D44.3 — D44.5, Q85.00 — Q85.09 and D49.6, and all tumors of the CNS of benign and uncertain behavior with ICD-O-3 codes of “0” or “1”), which includes codes from:</text> <paragraph num="(i)"> <text>The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM); and</text> </paragraph> <paragraph num="(ii)"> <text>The International Classification of Diseases for Oncology, Third Edition (ICD-O-3).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Case of reportable human cancer” means the identification of a human cancer from the following list, which includes codes from the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases for Oncology, Third Edition (ICD-O-3):</text> <paragraph num="(a)"> <text>All malignant neoplasms with ICD-10-CM Codes C00 — C43.9, C44.00, C44.09, C44.10_, C44.19_, C44.20_, C44.29_, C44.30_, C44.39_, C44.40, C44.49, C44.50_, C44.59_, C44.60_, C44.69_, C44.70_, C44.79_, C44.80, C44.89, C44.90, C44.99, C45._ — C96._, or with ICD-O-3 behavior code of “3”, including genital skin cancer of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other sites of skin cancer with ICD-O-3 topography codes C44.0 — C44.9 with one of the following ICD-O-3 histologies:</text> <paragraph num="(i)"> <text>M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin;</text> </paragraph> <paragraph num="(ii)"> <text>M-8010 — 8046 Epithelial carcinomas of skin;</text> </paragraph> <paragraph num="(iii)"> <text>M-8050 — 8084 Papillary and squamous cell carcinomas of skin (C44.02, C44.12_, C44.22_, C44.32_, C44.42, C44.52_, C44.62_, C44.72_, C44.82, C44.92); or</text> </paragraph> <paragraph num="(iv)"> <text>M-8090 — 8110 Basal cell carcinomas (C44.01, C44.11_, C44.21_, C44.31_, C44.41, C44.51_, C44.61_, C44.71_, C44.81, C44.91);</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>All malignant neoplasms with the following ICD-10-CM codes where ICD-O-3 behavior is “3” and ICD-O-3 histologies are reported except as follows:</text> <paragraph num="(i)"> <text>If there is evidence of multiple foci, lymph node involvement, or metastasis, C37 — Thymoma (M-8580);</text> </paragraph> <paragraph num="(ii)"> <text>C7A.020 — Malignant carcinoid tumor of the appendix (M-8240);</text> </paragraph> <paragraph num="(iii)"> <text>C54.1 — Endometrial stroma, low grade (M-8931);</text> </paragraph> <paragraph num="(iv)"> <text>If there is evidence of multiple foci, lymph node involvement, or metastasis, D48.1 — Stromal Tumor of the digestive system (GIST 8639);</text> </paragraph> <paragraph num="(v)"> <text>D48.60 — Phylloides tumor (M-9020);</text> </paragraph> <paragraph num="(vi)"> <text>D45 — Polycythema (M-9950);</text> </paragraph> <paragraph num="(vii)"> <text>D47.Z9 — Plasmacytoma (M-9731, M-9734);</text> </paragraph> <paragraph num="(viii)"> <text>D47.3 — Essential thrombocythemia (M-9962), D46.0, D46.1, D46.20, D46.21, D46A, D46B — Low grade myelodysplastic syndrome lesions (M-9980), D46.22 — High grade myelodysplastic syndrome lesions (M-9983), D46.C — Myelodysplastic syndrome with 5q deletion (M-9986), D469 — Myelodysplastic syndrome, unspecified (M-9975), D47.1 — Myelofibrosis with myeloid metaplasia (primary myelofibrosis) (M-9961), D47.Z1 — post-transplant lymphoproliferative disorder (M-9989), C94.40, C94.41, C94.42, D47.9, D47.Z9 — lympho and myeloproliferative disease (M-9960, M-9970);</text> </paragraph> <paragraph num="(ix)"> <text>C88.2 — Alpha and gamma heavy chain disease (M-9762) or Franklin disease (M-9763);</text> </paragraph> <paragraph num="(x)"> <text>C88.0 — Waldenstrom macroglobulinemia (M-9761);</text> </paragraph> <paragraph num="(xi)"> <text>D46.4 — Refractory anemia (M-9980); or</text> </paragraph> <paragraph num="(xii)"> <text>D46.1 — Refractory anemia with ringed sideroblasts (M-9982), refractory anemia with excess blasts (M-9983), or refractory anemia with excess blasts in transformation (M-9984);</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>All cases of carcinoma in situ with ICD-10-CM Codes D00._ — D09.9, D47.Z2, D49.511 — D49.519, D49.59, D78.31 — D78.34, and D89.40 — D89.49, or with ICD-O-3 behavior code of “2”, including genital skin cancers of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other skin cancers with ICD-O-3 topography codes C44.0_ — C44.9_ with one of the following ICD-O-3 histologies:</text> <paragraph num="(i)"> <text>M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin;</text> </paragraph> <paragraph num="(ii)"> <text>M-8010 — 8046 Epithelial carcinomas of skin;</text> </paragraph> <paragraph num="(iii)"> <text>M-8050 — 8084 Papillary and squamous cell carcinomas of skin; and</text> </paragraph> <paragraph num="(iv)"> <text>M-8090 — 8110 Basal cell carcinomas; or</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>All cases of intraepithelial neoplasia with ICD-O-3 histology code of M-8077/2:</text> <paragraph num="(i)"> <text>Including squamous intraepithelial neoplasia of the larynx (LIN), vagina (VAIN), vulva (VIN), and anus (AIN) (ICD-10-CM codes D02.0, D07.2, D07.1, and D01.3; and ICD-O-3 topography codes C52, C51, and C21._); and</text> </paragraph> <paragraph num="(ii)"> <text>Excluding squamous intraepithelial neoplasia of the cervix (CIN III) and glandular intraepithelial neoplasia of the prostate (PIN) (ICD-10-CM codes D06._ and D07.5; and ICD-O-3 topography codes C53 and C61.9).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Computerized file” means an electronic data file using software approved for use by the Secretary, containing complete cancer report information transferable to a master electronic database system maintained by the Department.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health or a designee.</text> </paragraph> <paragraph num="(8)"> <text>“Freestanding ambulatory care facility” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Freestanding laboratory” means a facility, place, establishment, or institution which performs a laboratory examination for a person, authorized by law to request the examination, in connection with the diagnosis of a reportable human cancer or CNS tumor, and is licensed by the State pursuant to COMAR 10.10.03, and:</text> <paragraph num="(a)"> <text>Not under the administrative control of a hospital; or</text> </paragraph> <paragraph num="(b)"> <text>Under the administrative control of a hospital for a diagnosis of reportable human cancer or CNS tumor of a nonhospitalized patient.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“General hospice care program” has the meaning stated in COMAR 10.07.21.02.</text> </paragraph> <paragraph num="(11)"> <text>“Hospital” means a facility which is licensed by the State pursuant to COMAR 10.07.01.</text> </paragraph> <paragraph num="(11-1)"> <text>“Maryland Cancer Registry Data Use Manual and Procedures” means the document that describes the Maryland cancer registry procedures for release of cancer data and that outlines the procedures to obtain both non-confidential aggregate data and confidential individual-level data.</text> </paragraph> <paragraph num="(12)"> <text>“Nursing facility” has the meaning stated in COMAR 10.07.02.01B.</text> </paragraph> <paragraph num="(13)"> <text>“Physician” means an individual who:</text> <paragraph num="(a)"> <text>Practices medicine, as defined in Health Occupations Article, §14-101, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Diagnoses or treats a case of reportable human cancer or a reportable human CNS tumor at a practice located in Maryland.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Reporting facility” means any of the following:</text> <paragraph num="(a)"> <text>A hospital, freestanding laboratory, freestanding ambulatory care facility, or therapeutic radiological center; or</text> </paragraph> <paragraph num="(b)"> <text>A physician who has care of or has diagnosed a case of reportable human cancer or reportable human CNS tumor for a nonhospitalized patient not otherwise reported.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Secretary” means the Secretary of Health or a designee of the Secretary.</text> </paragraph> <paragraph num="(16)"> <text>“Therapeutic radiological center” means a facility or institution:</text> <paragraph num="(a)"> <text>Performing radiological treatment for a person authorized by law to request the treatment in connection with a reportable human cancer or a reportable human CNS tumor; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed or registered by the State pursuant to COMAR 10.05.03 and not under the administrative control of a hospital.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Incorporation by Reference."> <text>The Maryland Cancer Registry Data Use Manual and Procedures (Maryland Department of Health, July 2016) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Establishment of a Cancer Registry."> <text>There is a cancer registry established within the Department, whose purpose is to collect reportable human cancer data and reportable human CNS tumor data to further the cancer control goals of the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Cancer Control Goals of the State."> <paragraph num="A."> <text>The cancer control goals of the State are to reduce the incidence and mortality of reportable human cancer and reportable human CNS tumors and racial, ethnic, gender, age, and geographic disparities in reportable human cancer and CNS tumor incidence and mortality in Maryland, by:</text> <paragraph num="(1)"> <text>Advancing the understanding of reportable human cancer and reportable human CNS tumor demographics;</text> </paragraph> <paragraph num="(2)"> <text>Describing reportable human cancer and reportable human CNS tumor sources, causes, risk factors, preventive measures, diagnostic tests, screening tests, treatment, and survival; and</text> </paragraph> <paragraph num="(3)"> <text>Evaluating the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and preventive services and programs related to reportable human cancer and reportable human CNS tumors.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Research that will further the cancer control goals of the State is research whose protocols have been reviewed by Department staff who have found that the research will:</text> <paragraph num="(1)"> <text>Advance scientific knowledge or advance knowledge of clinical practice related to cancer;</text> </paragraph> <paragraph num="(2)"> <text>Have approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;</text> </paragraph> <paragraph num="(3)"> <text>Have one or more investigators who have training and experience with the approaches and methods; and</text> </paragraph> <paragraph num="(4)"> <text>Be conducted in a scientific environment likely to contribute to the success of the research.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Content of a Cancer Report."> <text>A cancer report shall contain the following information, using the standard nomenclature contained in the North American Association of Central Cancer Registries' Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary:</text> <paragraph num="A."> <text>Reasonably obtained patient demographic information, including risk factors;</text> </paragraph> <paragraph num="B."> <text>Information on the industrial or occupational history of an individual with cancer, to the extent such information is available;</text> </paragraph> <paragraph num="C."> <text>Relevant information on the:</text> <paragraph num="(1)"> <text>Initial diagnosis, including the date of the diagnosis;</text> </paragraph> <paragraph num="(2)"> <text>Initial treatment;</text> </paragraph> <paragraph num="(3)"> <text>Extent of the disease by the end of the first hospitalization; and</text> </paragraph> <paragraph num="(4)"> <text>Extent of the disease within 2 months of diagnosis, if the information is available to the reporting facility, nursing facility, assisted living program, or general hospice care program;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Facility and other provider identification information; and</text> </paragraph> <paragraph num="E."> <text>Other requirements as considered necessary by the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reporting Requirements."> <paragraph num="A."> <text>A reporting facility shall submit a:</text> <paragraph num="(1)"> <text>Cancer report to the Secretary in a computerized file containing standard information required by the Secretary;</text> </paragraph> <paragraph num="(2)"> <text>Computerized file not less than quarterly; and</text> </paragraph> <paragraph num="(3)"> <text>Completed report of any new individual case of a reportable human cancer or reportable human CNS tumor not later than 6 months after diagnosis or treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nursing facility, an assisted living program, or a general hospice care program shall submit a cancer report containing information that is under the control of the facility to the Secretary if the Secretary requests a cancer report on a patient who has been a resident of the nursing facility, assisted living program, or general hospice care program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality of Cancer Reports."> <paragraph num="A."> <text>Information obtained under this chapter is not a medical record under Health-General Article, §4-301, Annotated Code of Maryland, but is subject to the confidentiality requirements of Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Secretary may release confidential data to:</text> <paragraph num="(1)"> <text>An institution or individual researcher for medical, epidemiological, health care, or other cancer-related or CNS tumor-related research approved by the Secretary and the Department's Institutional Review Board (IRB) in order to further the cancer control goals of the State set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A reporting facility which:</text> <paragraph num="(a)"> <text>Routinely submits information on cases of reportable human cancer or reportable human CNS tumors to the cancer registry;</text> </paragraph> <paragraph num="(b)"> <text>Has been formally accepted as a participant in the cancer registry system; and</text> </paragraph> <paragraph num="(c)"> <text>Requests data relating to patients reported by the facility;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An out-of-State cancer registry or cancer control agency which requests routine data if the:</text> <paragraph num="(a)"> <text>Patient is a resident of the other state; and</text> </paragraph> <paragraph num="(b)"> <text>Other state has authority to provide equivalent information on Maryland residents to this State;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Each county health officer and the Baltimore City Commissioner of Health; and</text> </paragraph> <paragraph num="(5)"> <text>Another governmental agency performing its lawful duties pursuant to State or federal law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may release confidential information, subject to:</text> <paragraph num="(1)"> <text>A determination by the Secretary that a recipient of the information disclosed will maintain the confidentiality of the disclosed information; and</text> </paragraph> <paragraph num="(2)"> <text>An agreement signed by the Secretary and by the recipient of the confidential information that the recipient of the information will maintain the confidentiality of the disclosed information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary shall release confidential data to a requestor in response to a written request only, in accordance with Health-General Article, §§4-101 and 4-102, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>A reporting facility that in good faith submits a cancer report to the Secretary is not liable in any cause of action arising from the submission of the cancer report to the Secretary.</text> </paragraph> <paragraph num="F."> <text>The use or publication of any statistics, information, or other material that summarizes or refers to confidential records in the aggregate, without disclosing the identity of any person who is the subject of the confidential record is not subject to the provisions of Health-General Article, §4-102, Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>The Secretary shall release cancer data in accordance with the procedures outlined in the Maryland Cancer Registry Data Use Manual and Procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Authority and Requirements of the Secretary."> <paragraph num="A."> <text>To assure compliance by a reporting facility, nursing facility, assisted living program, or general hospice care program with Regulation .05 of this chapter, the Secretary may, upon advance notice, inspect a representative sample of medical records, pathology reports, or radiological reports maintained by the facility of cases of reportable human cancer and reportable human CNS tumors.</text> </paragraph> <paragraph num="B."> <text>The Secretary may charge a reasonable fee to cover the cost of providing data reports to appropriate requestors, as allowed by COMAR 10.01.08.04. All applicable fees shall be paid in full in advance of filling the request.</text> </paragraph> <paragraph num="C."> <text>After receiving all necessary information to support a request to release cancer registry data, the Secretary shall act in a timely manner and decide on the request with one of the following outcomes:</text> <paragraph num="(1)"> <text>Final approval;</text> </paragraph> <paragraph num="(2)"> <text>Interim approval, if the request has been accepted with one or more conditions which shall be met before final approval is granted; or</text> </paragraph> <paragraph num="(3)"> <text>Disapproval.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary, in accordance with State Government Article, §2-1246, Annotated Code of Maryland, shall submit an annual report to the Governor and General Assembly on the activities of the cancer registry, including use of cancer registry data.</text> </paragraph> <paragraph num="E."> <text>Nothing in this chapter is intended to limit or otherwise restrict the Secretary from obtaining cancer report information on Maryland residents from sources located either inside or outside the State.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 18-104, 18-203 and 18-204, Annotated Code of Maryland; 42 U.S.C. §280(e)</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 28, 1992 (19:19 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 21, 1997 (24:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 26, 1993 (20:8 Md. R. 723); April 21, 1997 (24:8 Md. R. 616); June 23, 2003 (30:12 Md. R. 788)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 21, 1997 (24:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective June 23, 2003 (30:12 Md. R. 788)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective June 23, 2003 (30:12 Md. R. 788)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, D amended effective June 23, 2003 (30:12 Md. R. 788)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 22, 2010 (37:6 Md. R. 478)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective January 13, 2011 (38:1 Md. R. 11)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective January 13, 2011 (38:1 Md. R. 11)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G adopted effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective January 13, 2011 (38:1 Md. R. 11)</annotation> </annotations> </chapter> <chapter num="02" heading="Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter defines the reimbursed services for the diagnosis and treatment of breast cancer, cervical cancer, or precancerous cervical lesions, outlines the requirements for patient eligibility, and outlines the reimbursement and billing procedures for the reimbursed services.</text> </paragraph> <paragraph num="B."> <text>This chapter also defines the:</text> <paragraph num="(1)"> <text>Responsibilities and duties of the Department, the participating local health department, the hospital-coordinated breast and cervical cancer screening program, the health care provider who determines patient eligibility and refers patients to the Program, and the following participating providers:</text> <paragraph num="(a)"> <text>Physician;</text> </paragraph> <paragraph num="(b)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(c)"> <text>Certified nurse midwife;</text> </paragraph> <paragraph num="(d)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(e)"> <text>Nurse anesthetist;</text> </paragraph> <paragraph num="(f)"> <text>Physical therapist;</text> </paragraph> <paragraph num="(g)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(h)"> <text>Hospital;</text> </paragraph> <paragraph num="(i)"> <text>Medical supply company;</text> </paragraph> <paragraph num="(j)"> <text>Home health services provider;</text> </paragraph> <paragraph num="(k)"> <text>Medical laboratory;</text> </paragraph> <paragraph num="(l)"> <text>Freestanding ambulatory surgical center; and</text> </paragraph> <paragraph num="(m)"> <text>Occupational therapist; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Process for termination from the Program and the procedure for appealing termination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where the patient stays at least overnight.</text> </paragraph> <paragraph num="(2)"> <text>“Ambulatory surgical center” means a distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization.</text> </paragraph> <paragraph num="(3)"> <text>“Annual gross income” means the total amount received per year from all sources before taxes are withheld.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant” means an individual who has applied to be eligible to have certain health care costs associated with the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion paid for by the Department.</text> </paragraph> <paragraph num="(5)"> <text>“Biopsy” means the removal and microscopic examination of tissue from the living human body, performed to establish a precise diagnosis.</text> </paragraph> <paragraph num="(6)"> <text>“Breast reconstruction” means surgery performed after the removal of a breast as a result of breast cancer to reestablish symmetry between the two breasts.</text> </paragraph> <paragraph num="(7)"> <text>“Certified nurse anesthetist” means a registered nurse who:</text> <paragraph num="(a)"> <text>By reason of certification under COMAR 10.27.06, may practice in Maryland under the terms of those regulations; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Certified nurse midwife” means a registered nurse who:</text> <paragraph num="(a)"> <text>By reason of certification under COMAR 10.27.05, may practice in Maryland under the terms of those regulations; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Certified nurse practitioner” means a registered nurse who:</text> <paragraph num="(a)"> <text>By reason of certification under COMAR 10.27.07, may practice in Maryland under the terms of those regulations; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Cervical carcinoma in-situ” means cancer that involves only the intraepithelial layer of the cervix.</text> </paragraph> <paragraph num="(11)"> <text>“Clinical breast examination” is a physical examination of the breast performed by a qualified health professional for the purpose of detecting breast cancer.</text> </paragraph> <paragraph num="(12)"> <text>“Clinically significant mass” means the presence of a discrete, dominant, palpable lump that raises the level of concern by either a patient or a provider.</text> </paragraph> <paragraph num="(13)"> <text>“Controlled clinical trial” means a research study that:</text> <paragraph num="(a)"> <text>Is conducted with cancer patients to evaluate the safety and effectiveness of a new treatment;</text> </paragraph> <paragraph num="(b)"> <text>Is conducted after basic research in laboratory and animal studies have been well tested, and researchers have reason to believe that the new treatment will be as good as, or better than, current standard treatment;</text> </paragraph> <paragraph num="(c)"> <text>Is reviewed for medical ethics, patient safety, and scientific merit by a research institution;</text> </paragraph> <paragraph num="(d)"> <text>Includes an informed consent in which the patient is given information about the study and the potential benefits and risks; and</text> </paragraph> <paragraph num="(e)"> <text>Involves review of the protocol and progress of the study and provides for monitoring the data and the safety of the patient during and after the study by researchers at places other than the institution at which the study is conducted.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(15)"> <text>“Diagnosis” means a histopathologic finding of breast cancer, cervical cancer, or a precancerous cervical lesion in a biopsy specimen.</text> </paragraph> <paragraph num="(16)"> <text>“Direct supervision” means that the physical therapist employer is physically present in the same area of the facility as the physical therapy assistant who provides service.</text> </paragraph> <paragraph num="(17)"> <text>“Disposable medical supplies” means consumable medical items with minimal or no potential for reuse.</text> </paragraph> <paragraph num="(18)"> <text>“Durable medical equipment” means equipment which satisfies all of the following requirements:</text> <paragraph num="(a)"> <text>Can withstand repeated use;</text> </paragraph> <paragraph num="(b)"> <text>Is used to serve a medical purpose; and</text> </paragraph> <paragraph num="(c)"> <text>Is appropriate for use in the home.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Eligible patient” means an applicant who has been determined to meet certain general, medical, health insurance, and financial criteria.</text> </paragraph> <paragraph num="(20)"> <text>“Excisional biopsy” means the removal of the entire tumor mass for cytologic examination.</text> </paragraph> <paragraph num="(21)"> <text>“Experimental drug” means a drug or biological not:</text> <paragraph num="(a)"> <text>Approved by the Food and Drug Administration for the treatment of breast cancer or cervical cancer; and</text> </paragraph> <paragraph num="(b)"> <text>Used under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by:</text> <paragraph num="(i)"> <text>The National Institutes of Health (NIH) or one of the NIH’s centers or cooperative groups;</text> </paragraph> <paragraph num="(ii)"> <text>The Food and Drug Administration through an investigational new drug exemption;</text> </paragraph> <paragraph num="(iii)"> <text>The Department of Veterans Affairs; or</text> </paragraph> <paragraph num="(iv)"> <text>A qualified nongovernmental research entity as identified in guidelines issued by the NIH.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Experimental treatment” means a medical procedure or service for breast cancer, cervical cancer, or a precancerous cervical lesion that is not performed under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by:</text> <paragraph num="(a)"> <text>The National Institutes of Health (NIH) or one of the NIH's centers or cooperative groups;</text> </paragraph> <paragraph num="(b)"> <text>The Food and Drug Administration through an investigational new drug exemption;</text> </paragraph> <paragraph num="(c)"> <text>The Department of Veterans Affairs; or</text> </paragraph> <paragraph num="(d)"> <text>A qualified nongovernmental research entity as identified in guidelines issued by the NIH.</text> </paragraph> </paragraph> <paragraph num="(22-1)"> <text>“Explanation of benefits” means the statement sent to a patient or provider, or both, in a health plan that lists:</text> <paragraph num="(a)"> <text>The health care services provided;</text> </paragraph> <paragraph num="(b)"> <text>The amounts paid by the plan; and</text> </paragraph> <paragraph num="(c)"> <text>The total amount billed to the patient.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Family” means the unit comprised of the applicant or the applicant and one or more of the following:</text> <paragraph num="(a)"> <text>Spouse;</text> </paragraph> <paragraph num="(b)"> <text>A financially dependent child; or</text> </paragraph> <paragraph num="(c)"> <text>A financially dependent relative.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Freestanding ambulatory surgical center” means a unit capable of providing ambulatory surgical services which is not located in a hospital setting and which is:</text> <paragraph num="(a)"> <text>Certified by Medicare through the Health Care Finance Administration (HCFA) regional office to furnish ambulatory surgical services directly to patients; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed by the State.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Homebound” means the status of a patient who is confined to the home due to a medical condition.</text> </paragraph> <paragraph num="(26)"> <text>“Home health services provider” means a public or private agency or organization, or part of any agency or organization, that:</text> <paragraph num="(a)"> <text>Meets one of the following licensure requirements:</text> <paragraph num="(i)"> <text>Is licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>If the entity is part of a hospital or related institution located in Maryland, is licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>If the entity is located outside of Maryland, is legally authorized to provide home health services in the jurisdiction in which the service is provided; or</text> </paragraph> <paragraph num="(iv)"> <text>Is a registered nurse licensed pursuant to Health Occupations Article, §§8-101 and 8-301—8-315, Annotated Code of Maryland, with a contractual agreement with the Department to provide skilled nursing care;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provides nursing or physical therapy services in the home; and</text> </paragraph> <paragraph num="(c)"> <text>Meets the requirements for participation in Medicare.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(28)"> <text>“Initial physical therapy evaluation” means the determination of the condition of the patient by a physical therapist through the administration of appropriate tests and a written case history on the first visit.</text> </paragraph> <paragraph num="(29)"> <text>“Innovator multiple source drug” has the meaning set forth at 42 U.S.C. §1396r-8(k)(7), as amended, which is incorporated by reference.</text> </paragraph> <paragraph num="(30)"> <text>“Insurer” means a private carrier, nonprofit health service plan, or health maintenance organization that administers or provides reimbursement for health care benefits on an expense-incurred basis.</text> </paragraph> <paragraph num="(31)"> <text>“Intermittent basis” means a service which is furnished on or at medically predictable and recurring intervals.</text> </paragraph> <paragraph num="(32)"> <text>“Invasive cervical cancer” means cancer which has spread beyond the intraepithelial layer of the cervix or beyond to other body tissues and organs.</text> </paragraph> <paragraph num="(33)"> <text>“Invoice” means a:</text> <paragraph num="(a)"> <text>Form issued or approved by the Department for use by a provider in submitting bills for payment; or</text> </paragraph> <paragraph num="(b)"> <text>Bill issued by a manufacturer or wholesaler to the provider which indicates proof of purchase and the price paid by the provider.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Legend drug” means a substance used as a medicine which is prescribed by a licensed health care provider in accordance with federal or State law.</text> </paragraph> <paragraph num="(35)"> <text>“Local health department” means the Baltimore City or a county-wide organization providing health services operated by the local health officer and under the supervision of the Department.</text> </paragraph> <paragraph num="(36)"> <text>“Mammogram” means an X-ray of the breast that is performed to detect breast cancer.</text> </paragraph> <paragraph num="(37)"> <text>“Maryland Health Insurance Plan (MHIP)” means the nonprofit entity established under Insurance Article, §§14-501—14-509, Annotated Code of Maryland, to provide affordable, comprehensive health coverage for medically uninsurable Maryland residents.</text> </paragraph> <paragraph num="(38)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible and medically needy low income individuals.</text> </paragraph> <paragraph num="(39)"> <text>“Medical case manager” means the participating physician or participating nurse practitioner who is responsible for making the medical decisions about the course of diagnosis and treatment for an eligible patient.</text> </paragraph> <paragraph num="(40)"> <text>“Medical laboratory” means a licensed or certified facility operated for the examination of material derived from the human body, by one or more scientific disciplines, for the purpose of obtaining information that may be used to aid in the diagnosis, treatment, and management of breast and cervical cancer.</text> </paragraph> <paragraph num="(41)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(42)"> <text>“Needle biopsy” means the removal of tissue from a solid mass with a needle.</text> </paragraph> <paragraph num="(43)"> <text>“Needle localization” means the application of radiologically guided needles to isolate breast lesions preoperatively.</text> </paragraph> <paragraph num="(44)"> <text>“Negative mammogram” means the X-ray revealed:</text> <paragraph num="(a)"> <text>Nothing of medical significance to comment on;</text> </paragraph> <paragraph num="(b)"> <text>A finding which is non-significant, but which may need to be described; or</text> </paragraph> <paragraph num="(c)"> <text>A finding which is probably non-significant, but which may need to be described and which suggests the need for short interval follow-up.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Occupational therapist” means an individual licensed by the Maryland Board of Occupational Therapy Practice or similarly licensed in the state in which the service is provided.</text> </paragraph> <paragraph num="(46)"> <text>“Oncologist” means a physician who specializes in the treatment of cancer.</text> </paragraph> <paragraph num="(47)"> <text>“Over-the-counter drug” means a substance used as a medicine that does not require a prescription under federal or State law.</text> </paragraph> <paragraph num="(48)"> <text>“Participating health care provider” means a local health department, hospital, or a participating:</text> <paragraph num="(a)"> <text>Certified nurse midwife;</text> </paragraph> <paragraph num="(b)"> <text>Freestanding ambulatory surgical center;</text> </paragraph> <paragraph num="(c)"> <text>Home health services provider;</text> </paragraph> <paragraph num="(d)"> <text>Hospital;</text> </paragraph> <paragraph num="(e)"> <text>Medical laboratory;</text> </paragraph> <paragraph num="(f)"> <text>Medical supply company;</text> </paragraph> <paragraph num="(g)"> <text>Nurse anesthetist;</text> </paragraph> <paragraph num="(h)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(i)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(j)"> <text>Physical therapist;</text> </paragraph> <paragraph num="(k)"> <text>Physician;</text> </paragraph> <paragraph num="(l)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(m)"> <text>Occupational therapist; or</text> </paragraph> <paragraph num="(n)"> <text>Other appropriate health care providers.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“Part-time basis” means services usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of breast and cervical cancer.</text> </paragraph> <paragraph num="(50)"> <text>“Patient contribution amount” means the amount of money required by an individual's health insurance policy to be paid by the individual for a given medical service received, excluding the deductible.</text> </paragraph> <paragraph num="(51)"> <text>“Pharmacist” means an individual licensed to practice pharmacy in Maryland.</text> </paragraph> <paragraph num="(52)"> <text>“Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(53)"> <text>“Phase-III controlled clinical trial” means a research study using an experimental drug or treatment which:</text> <paragraph num="(a)"> <text>Has been shown to be effective in the treatment of breast or cervical cancer; and</text> </paragraph> <paragraph num="(b)"> <text>May be compared with current standard treatment to evaluate which is more effective.</text> </paragraph> </paragraph> <paragraph num="(54)"> <text>“Physical therapist” means an individual licensed or registered by the Maryland Board of Physical Therapy Examiners or similarly licensed or registered in the state in which the service is provided.</text> </paragraph> <paragraph num="(55)"> <text>“Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a physical therapist, and performing those physical therapy procedures that are assigned by a physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(56)"> <text>“Physical therapy aide” means a non-licensed individual in the employ of a physical therapist.</text> </paragraph> <paragraph num="(57)"> <text>“Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(58)"> <text>“Physician assistant” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed to practice medicine under the supervision of a physician under Health Occupations Article, Title 15, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the licensure requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State.</text> </paragraph> </paragraph> <paragraph num="(59)"> <text>“Prescriber” means a participating health care provider licensed to prescribe legend drugs in the state in which the service is provided.</text> </paragraph> <paragraph num="(60)"> <text>“Prescription” means a written order for medication, medical supplies, or equipment signed by the prescriber.</text> </paragraph> <paragraph num="(61)"> <text>“Program” means the Breast and Cervical Cancer Diagnosis and Treatment Program within the Department established to:</text> <paragraph num="(a)"> <text>Reimburse for breast and cervical cancer diagnostic and treatment services provided by participating health care providers to eligible patients; and</text> </paragraph> <paragraph num="(b)"> <text>Pay for MHIP coverage, if available, for eligible patients in lieu of providing direct reimbursement to participating health care providers.</text> </paragraph> </paragraph> <paragraph num="(62)"> <text>“Progress note” means a dated, written notation which summarizes facts about the patient care given and the patient response during a given period of time that:</text> <paragraph num="(a)"> <text>Specifically addresses the established goals of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Is consistent with the patient plan of care;</text> </paragraph> <paragraph num="(c)"> <text>Is written immediately following each visit; and</text> </paragraph> <paragraph num="(d)"> <text>Is part of the permanent patient record.</text> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Radiological examination of a breast surgical specimen” means an X-ray of the surgically removed tissue to ensure that the specimen contains the area of suspicion.</text> </paragraph> <paragraph num="(64)"> <text>“Release of patient information” means a Departmental consent form signed by the patient granting permission to certain individuals to allow the release of certain medical and demographic information for the purpose of follow-up, reimbursement, and medical case management.</text> </paragraph> <paragraph num="(65)"> <text>“Resident” means an individual who is currently living in, and intends to remain living within, Maryland.</text> </paragraph> <paragraph num="(66)"> <text>“Single source drug” means a drug that is:</text> <paragraph num="(a)"> <text>Available from only one producer or distributor; and</text> </paragraph> <paragraph num="(b)"> <text>Produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug marketed by a producer or distributor operating under the new drug application.</text> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Stage I breast cancer” means a tumor 2 centimeters or less in greatest dimension without regional lymph node or distant metastasis.</text> </paragraph> <paragraph num="(68)"> <text>“Staging” means the categorization of a cancer according to tumor size, regional lymph node involvement, and metastasis to distant areas in the body.</text> </paragraph> <paragraph num="(69)"> <text>“Treatment” means the medical management and care of a patient for breast cancer, cervical cancer, or a precancerous cervical lesion.</text> </paragraph> <paragraph num="(70)"> <text>“Utilization control agent” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to applicable professional standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Patient Eligibility."> <paragraph num="A."> <text>To be eligible to have a covered service reimbursed under the Program, an applicant shall:</text> <paragraph num="(1)"> <text>Be a resident;</text> </paragraph> <paragraph num="(2)"> <text>Be screened for breast cancer or cervical cancer, or both, by a:</text> <paragraph num="(a)"> <text>Hospital;</text> </paragraph> <paragraph num="(b)"> <text>Local health department; or</text> </paragraph> <paragraph num="(c)"> <text>Health care provider;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be found to have an eligible medical condition as described in §B of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Meet the health insurance criteria specified in §C of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Meet the financial eligibility criteria of an annual gross income that is not more than 250 percent of the federal poverty guidelines, as amended, which are incorporated by reference and updated periodically in the Federal Register by the U.S. Department of Health and Human Services; and</text> </paragraph> <paragraph num="(6)"> <text>Receive a medical service only from participating health care providers for breast cancer diagnosis, breast cancer treatment, cervical cancer diagnosis, or cervical cancer or precancer treatment, or any combination of these services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A medical condition which may render an applicant medically eligible includes the following:</text> <paragraph num="(1)"> <text>A mammogram, or breast ultrasound, or other diagnostic breast imaging requiring further diagnosis;</text> </paragraph> <paragraph num="(2)"> <text>A clinical breast examination requiring further diagnosis;</text> </paragraph> <paragraph num="(3)"> <text>A Pap test, or human papilloma virus test, or other approved cervical cancer screening test requiring further diagnosis;</text> </paragraph> <paragraph num="(4)"> <text>A breast biopsy which indicates the need for further diagnosis or treatment; or</text> </paragraph> <paragraph num="(5)"> <text>A cervical biopsy which indicates the need for further diagnosis or treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Health insurance statuses which may render an applicant eligible include the following:</text> <paragraph num="(1)"> <text>The applicant is not currently covered by health insurance, including Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>The applicant is covered by Medicare which:</text> <paragraph num="(a)"> <text>Does not provide reimbursement for the covered medical procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>Has a deductible for the year that has not been met; or</text> </paragraph> <paragraph num="(c)"> <text>Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The applicant has health insurance other than Medical Assistance or Medicare which:</text> <paragraph num="(a)"> <text>Does not provide reimbursement for the covered medical procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>Requires that a deductible be paid by the applicant for the covered medical procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>Reimburses at a rate lower than the Medical Assistance approved rate in the State; or</text> </paragraph> <paragraph num="(d)"> <text>Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The applicant is enrolled in one of the following Medical Assistance programs:</text> <paragraph num="(a)"> <text>Family Planning;</text> </paragraph> <paragraph num="(b)"> <text>Primary Adult Care (PAC);</text> </paragraph> <paragraph num="(c)"> <text>Specified Low Income Medicare Beneficiary (SLMB); or</text> </paragraph> <paragraph num="(d)"> <text>Qualified Medicare Beneficiary (QMB).</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant is not eligible if:</text> <paragraph num="(1)"> <text>The applicant is enrolled in a Medical Assistance program other than those listed in §C(4) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>During diagnosis or treatment of breast or cervical cancer, the applicant becomes enrolled in a Medical Assistance program other than those cited in §C(4) of this regulation; or</text> </paragraph> <paragraph num="(3)"> <text>Any of the criteria established in §§A—D of this regulation are not met.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An applicant is responsible for the following:</text> <paragraph num="(1)"> <text>Furnishing factual information regarding the applicant’s eligibility, including but not limited to verifying documents regarding financial eligibility and the applicability of health insurance;</text> </paragraph> <paragraph num="(2)"> <text>Completing, which may include the applicant providing the applicant's social security number, and signing the application form, provided that the Program informs the applicant that:</text> <paragraph num="(a)"> <text>The applicant's disclosure of the applicant's social security number on the application is voluntary;</text> </paragraph> <paragraph num="(b)"> <text>The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act (42 U.S.C. 405(c), as amended); and</text> </paragraph> <paragraph num="(c)"> <text>The applicant's social security number will be used only for the Program's administrative purposes; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completing and submitting a Medical Assistance application when notified by the Program that the applicant is considered potentially eligible.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Social Security Number Collection.</text> <paragraph num="(1)"> <text>An applicant is not required to have or disclose a social security number to be eligible for Program benefits.</text> </paragraph> <paragraph num="(2)"> <text>An applicant's disclosure of the applicant's social security number on the application form is voluntary.</text> </paragraph> <paragraph num="(3)"> <text>The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act at 42 U.S.C. §405(c)(2)(C)(i) and (vi), as amended.</text> </paragraph> <paragraph num="(4)"> <text>The Program may only use the social security number provided by an applicant to establish the identity of the applicant for administrative purposes.</text> </paragraph> <paragraph num="(5)"> <text>The Program may request a copy of an applicant's social security card for administrative purposes.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An eligible patient is responsible for the following:</text> <paragraph num="(1)"> <text>Keeping the Program, local health department, hospital, or health care provider who determines the patient’s eligibility for the Program informed of any change in health insurance status;</text> </paragraph> <paragraph num="(2)"> <text>Selecting and using only a participating health care provider; and</text> </paragraph> <paragraph num="(3)"> <text>Signing the release of patient information form for the Program developed and approved by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Physician Services."> <paragraph num="A."> <text>To be considered a participating physician in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Provide a medical procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion;</text> </paragraph> <paragraph num="(2)"> <text>Have a current license to practice medicine in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate approved by the insurer plus the payment of the outstanding deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a reimbursed procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>The reimbursement rate approved by Medicare plus the payment of the outstanding deductible and the patient contribution amount by the Department for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(d)"> <text>For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the current Medical Assistance approved rate in the State plus the payment of the outstanding deductible by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Agree to abide by the provisions set forth in §A of this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(5)"> <text>Agree not to bill an eligible patient, who is uninsured or is covered by Medicare or other insurance, for an additional charge for the reimbursed medical procedure performed or service provided;</text> </paragraph> <paragraph num="(6)"> <text>Agree to:</text> <paragraph num="(a)"> <text>Be the medical case manager for an eligible patient; or</text> </paragraph> <paragraph num="(b)"> <text>Coordinate the reimbursed medical procedure or service with the designated medical case manager and submit the result of the procedure to the medical case manager;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Agree to the following medical guidelines:</text> <paragraph num="(a)"> <text>That a negative mammogram alone is not sufficient to evaluate a clinically significant mass, and to perform or arrange for further diagnostic evaluation of the mass;</text> </paragraph> <paragraph num="(b)"> <text>That a surgeon shall examine the patient and make the final determination of further diagnostic and treatment procedures needed when a needle biopsy performed by a non-surgeon is negative for cancer;</text> </paragraph> <paragraph num="(c)"> <text>To perform or arrange for needle localization of the mass before excisional biopsy;</text> </paragraph> <paragraph num="(d)"> <text>To perform or arrange for radiological examination of the breast surgical specimen after biopsy to accurately identify the mass;</text> </paragraph> <paragraph num="(e)"> <text>To refer an eligible patient with a mammography assessment recommending biopsy to a surgeon for evaluation and a decision regarding the ultimate course of action;</text> </paragraph> <paragraph num="(f)"> <text>To implement the diagnostic tests or procedures required for cancer staging determination in keeping with the best interests of the patient and to determine staging on the cancer found;</text> </paragraph> <paragraph num="(g)"> <text>To consult an oncologist before any treatment is initiated for Stage I or greater breast cancer or invasive cervical cancer; and</text> </paragraph> <paragraph num="(h)"> <text>To consult with a radiation oncologist if radiation treatment is a medical option;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Agree to maintain the results of the reimbursed medical procedures performed as set forth in §E(6)—(9) of this regulation;</text> </paragraph> <paragraph num="(9)"> <text>Agree to maintain administrative and health records, including medical records, to document compliance with this chapter for a minimum of 6 years and, upon request, allow the Department access to the records; and</text> </paragraph> <paragraph num="(10)"> <text>Place no restriction on the eligible patient's right to choose a provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An eligible medical provider may be, but is not limited to, one of the following:</text> <paragraph num="(1)"> <text>Anesthesiologist;</text> </paragraph> <paragraph num="(2)"> <text>Clinical-anatomical or cytopathological pathologist;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic, therapeutic, or nuclear radiologist;</text> </paragraph> <paragraph num="(4)"> <text>Family practitioner;</text> </paragraph> <paragraph num="(5)"> <text>Medical internist;</text> </paragraph> <paragraph num="(6)"> <text>Medical or gynecological oncologist;</text> </paragraph> <paragraph num="(7)"> <text>Obstetrician-gynecologist; or</text> </paragraph> <paragraph num="(8)"> <text>Surgeon.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reimbursed medical procedures include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Breast cancer diagnostic procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Cyst aspiration;</text> </paragraph> <paragraph num="(b)"> <text>Diagnostic ultrasound;</text> </paragraph> <paragraph num="(c)"> <text>Incisional, excisional, or other breast biopsy;</text> </paragraph> <paragraph num="(d)"> <text>Needle biopsy; and</text> </paragraph> <paragraph num="(e)"> <text>Needle localization;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Breast cancer treatment procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Adjuvant hormonal therapy;</text> </paragraph> <paragraph num="(b)"> <text>Adjuvant or sole chemotherapy;</text> </paragraph> <paragraph num="(c)"> <text>Adjuvant or sole radiation therapy;</text> </paragraph> <paragraph num="(d)"> <text>Lumpectomy with radiation;</text> </paragraph> <paragraph num="(e)"> <text>Lymph node dissection;</text> </paragraph> <paragraph num="(f)"> <text>Modified radical mastectomy;</text> </paragraph> <paragraph num="(g)"> <text>Radical mastectomy; and</text> </paragraph> <paragraph num="(h)"> <text>Simple mastectomy;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Contingent upon available funds, breast reconstruction procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Construction of breast mound;</text> </paragraph> <paragraph num="(b)"> <text>Augmentation mammoplasty;</text> </paragraph> <paragraph num="(c)"> <text>Reduction mammoplasty; and</text> </paragraph> <paragraph num="(d)"> <text>Mastopexy;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Cervical cancer or precancerous cervical lesion diagnostic procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Colposcopically directed cervical or vaginal biopsy, or both;</text> </paragraph> <paragraph num="(b)"> <text>Colposcopy;</text> </paragraph> <paragraph num="(c)"> <text>Endocervical curettage; and</text> </paragraph> <paragraph num="(d)"> <text>Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or has had cervical cancer documented;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Cervical cancer or precancerous cervical lesion treatment procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Conization;</text> </paragraph> <paragraph num="(b)"> <text>Cryosurgery;</text> </paragraph> <paragraph num="(c)"> <text>Dilation and curettage;</text> </paragraph> <paragraph num="(d)"> <text>Electric loop resection;</text> </paragraph> <paragraph num="(e)"> <text>Hysterectomy; and</text> </paragraph> <paragraph num="(f)"> <text>Laser treatment; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Follow-up to treatment for breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to:</text> <paragraph num="(a)"> <text>Follow-up office visits with the medical case manager; and</text> </paragraph> <paragraph num="(b)"> <text>Medical and laboratory tests ordered by the medical case manager.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Non-reimbursed medical procedures and services include but are not limited to:</text> <paragraph num="(1)"> <text>A screening mammogram;</text> </paragraph> <paragraph num="(2)"> <text>A Pap or human papilloma virus test;</text> </paragraph> <paragraph num="(3)"> <text>An experimental treatment other than a Phase-III controlled clinical trial for breast or cervical cancer;</text> </paragraph> <paragraph num="(4)"> <text>A procedure or service not related to the diagnosis and treatment of breast and cervical cancer;</text> </paragraph> <paragraph num="(5)"> <text>Organ transplants; and</text> </paragraph> <paragraph num="(6)"> <text>Nipple reconstruction or tattooing, or both.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The participating physician is responsible for the following:</text> <paragraph num="(1)"> <text>Medical liability for the medical procedure performed on a referred, eligible patient;</text> </paragraph> <paragraph num="(2)"> <text>Accepting a referral of an eligible patient from a local health department, hospital, or other health care provider;</text> </paragraph> <paragraph num="(3)"> <text>Performing a medical test needed by the eligible patient;</text> </paragraph> <paragraph num="(4)"> <text>Charging the patient for a non-reimbursed medical procedure performed;</text> </paragraph> <paragraph num="(5)"> <text>Submitting a bill for the reimbursed medical procedure performed or service provided on the designated Departmental form within 12 months of the date of service as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for the reimbursed medical procedure or service, the participating physician shall send to the Department the bill for the procedure or service, with a denial from the applicable insurance carrier, on the form designated by the Department;</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating physician shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance for the procedure or service in accordance with Medicare or the other insurance billing specifications; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible and patient contribution amount.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request:</text> <paragraph num="(a)"> <text>Sonogram or other breast cancer test which identifies an area as suspicious;</text> </paragraph> <paragraph num="(b)"> <text>Breast biopsy in which cancer is present; and</text> </paragraph> <paragraph num="(c)"> <text>Cervical biopsy which identifies a change associated with:</text> <paragraph num="(i)"> <text>Cervical carcinoma in situ;</text> </paragraph> <paragraph num="(ii)"> <text>Cervical intraepithelial neoplasia;</text> </paragraph> <paragraph num="(iii)"> <text>Invasive cervical cancer; or</text> </paragraph> <paragraph num="(iv)"> <text>The human papilloma virus;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request:</text> <paragraph num="(a)"> <text>Sonogram or other breast cancer test that is negative or shows a benign finding;</text> </paragraph> <paragraph num="(b)"> <text>Breast biopsy in which cancer is not present; and</text> </paragraph> <paragraph num="(c)"> <text>Cervical biopsy which is negative or shows a benign finding;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Maintaining and sending to the Department upon request, reports pertaining to the staging of the cancer; and</text> </paragraph> <paragraph num="(9)"> <text>Maintaining and sending to the Department, upon request, the result of a treatment procedure.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The participating physician may not bill the Department under this Program for:</text> <paragraph num="(1)"> <text>Completion of a form;</text> </paragraph> <paragraph num="(2)"> <text>A broken or missed appointment;</text> </paragraph> <paragraph num="(3)"> <text>A professional service rendered by mail or telephone; or</text> </paragraph> <paragraph num="(4)"> <text>A professional service provided to a patient enrolled in a Medical Assistance program other than those listed in Regulation .03C(4) of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Physician Assistant Services."> <paragraph num="A."> <text>To be considered a participating physician assistant in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be licensed to practice as a physician assistant in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have a current written executed delegation agreement with a licensed supervising physician who is licensed to practice medicine in Maryland or a jurisdiction bordering on Maryland, if required by that jurisdiction;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State of an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or services;</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or</text> </paragraph> <paragraph num="(d)"> <text>For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible and patient contribution amount by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and</text> </paragraph> <paragraph num="(5)"> <text>Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An eligible health care provider may be a physician assistant.</text> </paragraph> <paragraph num="C."> <text>The reimbursed medical services include services related to breast and cervical cancer rendered to participants in accordance with:</text> <paragraph num="(1)"> <text>The functions allowed under:</text> <paragraph num="(a)"> <text>The Physician Assistant’s Practice Act;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.32.03; and</text> </paragraph> <paragraph num="(c)"> <text>The physician assistant’s written delegation agreement with a physician; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If out-of-State, the functions authorized in the state in which the services are provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer.</text> </paragraph> <paragraph num="E."> <text>The participating physician assistant shall accept the responsibilities pursuant to Regulation .04E—G of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-2" heading="Certified Nurse Midwife Services."> <paragraph num="A."> <text>To be considered a participating certified nurse midwife in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be a certified nurse midwife in Maryland or a jurisdiction bordering on Maryland and hold all certifications as required by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(2)"> <text>Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate approved by the insurer plus the payment of the deductible by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or</text> </paragraph> <paragraph num="(d)"> <text>For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and</text> </paragraph> <paragraph num="(4)"> <text>Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided.</text> </paragraph> <paragraph num="C."> <text>The reimbursed medical procedure includes but is not limited to:</text> <paragraph num="(1)"> <text>Colposcopically directed cervical or vaginal biopsy or both:</text> </paragraph> <paragraph num="(2)"> <text>Colposcopy;</text> </paragraph> <paragraph num="(3)"> <text>Cyst aspiration;</text> </paragraph> <paragraph num="(4)"> <text>Endocervical curettage;</text> </paragraph> <paragraph num="(5)"> <text>Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented;</text> </paragraph> <paragraph num="(6)"> <text>Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or</text> </paragraph> <paragraph num="(7)"> <text>If out-of-State, nurse midwife services authorized in the state in which the services are provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer.</text> </paragraph> <paragraph num="E."> <text>The participating certified nurse midwife shall accept the responsibilities pursuant to Regulation .04E—G of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Nurse Practitioner Services."> <paragraph num="A."> <text>To be considered a participating nurse practitioner in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be a certified nurse practitioner in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have a current written attestation with a physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland, if required by that jurisdiction;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or</text> </paragraph> <paragraph num="(d)"> <text>For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and</text> </paragraph> <paragraph num="(5)"> <text>Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5)—(6), (7)(a)—(e), and (8)—(10) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An eligible health care provider may be a certified nurse practitioner.</text> </paragraph> <paragraph num="C."> <text>The reimbursed medical procedure includes but is not limited to:</text> <paragraph num="(1)"> <text>Colposcopically directed cervical or vaginal biopsy or both;</text> </paragraph> <paragraph num="(2)"> <text>Colposcopy;</text> </paragraph> <paragraph num="(3)"> <text>Cyst aspiration;</text> </paragraph> <paragraph num="(4)"> <text>Endocervical curettage; and</text> </paragraph> <paragraph num="(5)"> <text>Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer.</text> </paragraph> <paragraph num="E."> <text>The participating nurse practitioner shall accept the responsibilities pursuant to Regulation .04E, F, and G of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nurse Anesthetist Services."> <paragraph num="A."> <text>To be considered a participating nurse anesthetist in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be a certified nurse anesthetist in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland in the manner prescribed by COMAR 10.27.06 or by the jurisdiction in which the service is provided;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>The reimbursement rate approved by the insurer plus the payment of the deductible and the patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service;</text> </paragraph> <paragraph num="(c)"> <text>The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or</text> </paragraph> <paragraph num="(d)"> <text>For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and</text> </paragraph> <paragraph num="(5)"> <text>Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5),(6), (9), and (10) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An eligible health care provider may be a certified nurse anesthetist.</text> </paragraph> <paragraph num="C."> <text>The reimbursed medical procedure is anesthesia required for the diagnosis and treatment of breast cancer or cervical cancer.</text> </paragraph> <paragraph num="D."> <text>Non-reimbursed medical procedures and services include an anesthesia procedure or service not related to the diagnosis and treatment of breast cancer and cervical cancer.</text> </paragraph> <paragraph num="E."> <text>The participating nurse anesthetist provider shall accept the responsibilities pursuant to Regulation .04E(1)—(5), F, and G of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Physical Therapy Services."> <paragraph num="A."> <text>To be considered a participating physical therapist in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be a physical therapist licensed to practice physical therapy in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Follow standard health and safety procedures to protect an eligible patient from potential hazards;</text> </paragraph> <paragraph num="(4)"> <text>Agree to the medical and reporting requirements of the Program pursuant to Regulation .04A(5), (9), and (10) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient’s health insurer, if applicable; and</text> </paragraph> <paragraph num="(6)"> <text>Agree not to bill an eligible patient an additional charge for the covered service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall reimburse a participating physical therapist for a medically necessary physical therapy service ordered in writing by a participating physician when the service is:</text> <paragraph num="(1)"> <text>Provided by a physical therapist or by a physical therapist assistant under the direct supervision of a physical therapist;</text> </paragraph> <paragraph num="(2)"> <text>Provided in a physical therapy office or the patient's home;</text> </paragraph> <paragraph num="(3)"> <text>Considered one or more of the following:</text> <paragraph num="(a)"> <text>Diagnostic;</text> </paragraph> <paragraph num="(b)"> <text>Rehabilitative; or</text> </paragraph> <paragraph num="(c)"> <text>Therapeutic;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Directly related to the written treatment order;</text> </paragraph> <paragraph num="(5)"> <text>Of sufficient complexity and sophistication, or the condition of the patient is such that the service of a physical therapist is required;</text> </paragraph> <paragraph num="(6)"> <text>Rendered pursuant to a written treatment order which:</text> <paragraph num="(a)"> <text>Is signed and dated by the prescribing physician;</text> </paragraph> <paragraph num="(b)"> <text>Specifies the following:</text> <paragraph num="(i)"> <text>Body part to be treated;</text> </paragraph> <paragraph num="(ii)"> <text>Type of modality or treatment to be rendered;</text> </paragraph> <paragraph num="(iii)"> <text>Expected result of physical therapy treatment; and</text> </paragraph> <paragraph num="(iv)"> <text>Frequency and duration of treatment;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is kept on file by the physical therapist as a part of the permanent patient record subject to review by the Department or its designee;</text> </paragraph> <paragraph num="(d)"> <text>Is not altered by the physical therapist unless medically indicated, whereby the physical therapist shall make a necessary change and sign the treatment order, advising the prescribing physician of the change and noting it in the patient record;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Recorded in the permanent record to include the following:</text> <paragraph num="(a)"> <text>The treatment order;</text> </paragraph> <paragraph num="(b)"> <text>The initial evaluation by the physical therapist;</text> </paragraph> <paragraph num="(c)"> <text>Significant past history;</text> </paragraph> <paragraph num="(d)"> <text>Pertinent diagnoses and prognoses;</text> </paragraph> <paragraph num="(e)"> <text>Contraindications, if applicable; and</text> </paragraph> <paragraph num="(f)"> <text>Progress notes, at least once every 2 weeks;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>For a written treatment order for treatment exceeding 30 days and the participating physician:</text> <paragraph num="(a)"> <text>Reviews and rewrites the order monthly; or</text> </paragraph> <paragraph num="(b)"> <text>Initials and dates a copy of the original order monthly; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>For an initial physical therapy evaluation, on a one-time basis, per condition, when the requirements of this regulation are met.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program does not reimburse for services:</text> <paragraph num="(1)"> <text>Performed by a physical therapy assistant when not under the direct supervision of the physical therapist;</text> </paragraph> <paragraph num="(2)"> <text>Performed by a physical therapy aide; or</text> </paragraph> <paragraph num="(3)"> <text>Not directly related to the treatment of breast and cervical cancer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The participating physical therapist is responsible for the following:</text> <paragraph num="(1)"> <text>Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form;</text> </paragraph> <paragraph num="(2)"> <text>Certifying on the invoice that the treatment order is on file and was in effect at the time that services were rendered; and</text> </paragraph> <paragraph num="(3)"> <text>Specifying on the invoice the type of treatment provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Department shall reimburse the participating physical therapist:</text> <paragraph num="(a)"> <text>The current Medical Assistance approved rate in the State for a covered service performed in the provider’s office for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service;</text> </paragraph> <paragraph num="(b)"> <text>The outstanding deductible and patient contribution for a covered service performed in the provider’s office for an eligible patient who has Medicare or other insurance that provides reimbursement for a covered procedure or service; and</text> </paragraph> <paragraph num="(c)"> <text>For covered services performed in the home of an eligible patient pursuant to Regulation .11F of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not reimburse the participating physical therapist for:</text> <paragraph num="(a)"> <text>Services rendered by mail or telephone;</text> </paragraph> <paragraph num="(b)"> <text>Completion of a form or report;</text> </paragraph> <paragraph num="(c)"> <text>A broken or missed appointment; or</text> </paragraph> <paragraph num="(d)"> <text>A service which is provided at no charge to the general public.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The participating physical therapist shall obtain recovery pursuant to Regulation .17 of this chapter.</text> </paragraph> <paragraph num="G."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Pharmacy Services."> <paragraph num="A."> <text>To be considered a participating pharmacy in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Obtain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient's health insurer, if applicable;</text> </paragraph> <paragraph num="(4)"> <text>Agree not to bill an eligible patient for an additional charge for the reimbursed pharmacy services provided; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain adequate prescription and administrative records for a minimum of 5 years and, upon request, allow the Department access to the records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reimbursed pharmacy services include but are not limited to the following:</text> <paragraph num="(1)"> <text>A prescription, when ordered and signed by a prescriber for an eligible patient, within the limits established by the Program which includes:</text> <paragraph num="(a)"> <text>A legend drug, including but not limited to the following drug classifications:</text> <paragraph num="(i)"> <text>Analgesic;</text> </paragraph> <paragraph num="(ii)"> <text>Antidepressant;</text> </paragraph> <paragraph num="(iii)"> <text>Antiemetic;</text> </paragraph> <paragraph num="(iv)"> <text>Anti-infective;</text> </paragraph> <paragraph num="(v)"> <text>Antineoplastic agent;</text> </paragraph> <paragraph num="(vi)"> <text>Benzodiazepine;</text> </paragraph> <paragraph num="(vii)"> <text>Colony stimulating factor;</text> </paragraph> <paragraph num="(viii)"> <text>Hormone; and</text> </paragraph> <paragraph num="(ix)"> <text>Individual vitamin; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An especially formulated enteral or parenteral nutritional preparation required for a patient with a documented pathologic condition, when treatment is medically necessary and life sustaining;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Hypodermic needle and syringe;</text> </paragraph> <paragraph num="(3)"> <text>Over-the-counter iron preparation;</text> </paragraph> <paragraph num="(4)"> <text>Durable medical equipment as specified in Regulation .10B of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>A disposable medical supply as specified in Regulation .10B of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Non-reimbursed pharmacy services include but are not limited to:</text> <paragraph num="(1)"> <text>An over-the-counter drug, excluding iron preparations;</text> </paragraph> <paragraph num="(2)"> <text>A legend drug for which federal finance participation is prohibited pursuant to 42 CFR §441.25;</text> </paragraph> <paragraph num="(3)"> <text>An experimental drug; and</text> </paragraph> <paragraph num="(4)"> <text>A drug not directly related to the diagnosis and treatment of breast or cervical cancer or a complication of treatment for breast or cervical cancer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The participating pharmacy responsibilities are as follows:</text> <paragraph num="(1)"> <text>Monitoring an eligible patient’s file for contraindications and toxicity; and</text> </paragraph> <paragraph num="(2)"> <text>Submitting a bill on the designated Departmental form for the reimbursed:</text> <paragraph num="(a)"> <text>Medication;</text> </paragraph> <paragraph num="(b)"> <text>Durable medical equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Disposable medical supply.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall reimburse the participating pharmacy:</text> <paragraph num="(1)"> <text>Pursuant to COMAR 10.09.03.07A—G, H(1)—(3), and (5)—(6); and</text> </paragraph> <paragraph num="(2)"> <text>For the deductible or patient contribution amount, or both.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The participating pharmacy shall obtain recovery pursuant to COMAR 10.09.03.08.</text> </paragraph> <paragraph num="G."> <text>Periodic peer review may be performed by the Department or its designee.</text> </paragraph> <paragraph num="H."> <text>Except as provided in §I of this regulation, a drug manufacturer shall pay drug rebates to the Department for reimbursable pharmacy services in the same manner and amount that rebates are provided to the State for State-Only and Pharmacy Assistance recipients' purchases of drugs in accordance with §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)) which is incorporated by reference.</text> </paragraph> <paragraph num="I."> <text>Limitations.</text> <paragraph num="(1)"> <text>The Department shall provide notice to a drug manufacturer who fails to provide adequate rebates in accordance with this chapter indicating that the manufacturer shall pay the drug rebate unless:</text> <paragraph num="(a)"> <text>The manufacturer submits a written request to the Secretary for a waiver of the rebate requirement; and</text> </paragraph> <paragraph num="(b)"> <text>The Secretary grants a waiver under §I(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary shall grant a waiver to the requirement set forth in §H of this regulation only if the Secretary determines that the drug manufacturer has demonstrated that:</text> <paragraph num="(a)"> <text>The drug is a single source drug or an innovator multiple source drug;</text> </paragraph> <paragraph num="(b)"> <text>The Department has determined that the drug is essential to the health of the eligible patient;</text> </paragraph> <paragraph num="(c)"> <text>The drug has been given a rating of I-A by the Food and Drug Administration; and</text> </paragraph> <paragraph num="(d)"> <text>The physician has obtained the Department's authorization for use of the drug before prescribing the drug to the eligible patient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>No manufacturer or its designee may dispute or request repayment of any rebate paid under §H of this regulation more than 3 years after the date the rebate was paid.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Except when a manufacturer has been granted a waiver to the rebate requirement under §I of this regulation, the Program may not pay for a drug under this chapter if the manufacturer has not provided a rebate to the Program in accordance with §H of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Hospital Services."> <paragraph num="A."> <text>To be considered a participating hospital in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be licensed as a hospital in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Agree not to bill an eligible patient for an additional charge for the reimbursed hospital services provided; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain adequate records for a minimum of 5 years and, upon request, allow the Department access to the records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The participating hospital shall receive reimbursement for the following services:</text> <paragraph num="(1)"> <text>Medically necessary inpatient hospital service for the number of days, per admission, including preoperative days certified by the utilization control agent, which is:</text> <paragraph num="(a)"> <text>Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and</text> </paragraph> <paragraph num="(b)"> <text>Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medically necessary outpatient hospital service which is:</text> <paragraph num="(a)"> <text>Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and</text> </paragraph> <paragraph num="(b)"> <text>Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Limitations. The limitations on coverage of some hospital inpatient and outpatient services contained in COMAR 10.09.92.05 apply to this Program.</text> </paragraph> <paragraph num="D."> <text>Preauthorization Requirements.</text> <paragraph num="(1)"> <text>The following surgical procedures require preauthorization when performed on a hospital inpatient basis unless the patient is already a hospital inpatient for another condition, or an unrelated procedure is being done simultaneously which itself requires surgical hospitalization. If an emergency necessitates performing any of the listed procedures on an inpatient basis, the provider shall request and obtain post-authorization before billing. The procedures are:</text> <paragraph num="(a)"> <text>Biopsy;</text> </paragraph> <paragraph num="(b)"> <text>Breast biopsy if a two-stage procedure is planned for a possible malignancy;</text> </paragraph> <paragraph num="(c)"> <text>Colposcopy;</text> </paragraph> <paragraph num="(d)"> <text>Cryotherapy alone;</text> </paragraph> <paragraph num="(e)"> <text>Cryotherapy with biopsy or dilation and curettage, or both;</text> </paragraph> <paragraph num="(f)"> <text>Dilation and curettage;</text> </paragraph> <paragraph num="(g)"> <text>Excision of benign lesion; and</text> </paragraph> <paragraph num="(h)"> <text>Hysteroscopy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Authorization is required by the Program for all preoperative inpatient days.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The participating hospital is responsible for:</text> <paragraph num="(1)"> <text>Submitting a bill for the reimbursed services provided on the designated Departmental form as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating hospital shall send the Department the bill for the service, with a denial from the patient’s insurance carrier, within 12 months of the date of discharge or outpatient service; or</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating hospital shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance for the procedure or service; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible and patient contribution amount;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documenting the sum collected from the eligible patient's insurer as a patient collection; and</text> </paragraph> <paragraph num="(3)"> <text>Submitting properly completed attachments with the bill as requested by the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Program shall reimburse for a room and board charge for the day of admission, and may not reimburse for a room and board charge for the day of discharge from the participating hospital.</text> </paragraph> <paragraph num="(2)"> <text>The participating hospital may not collect a total payment, including the eligible patient's insurance and the Department's payment, which exceeds the provider's rate established by the Department or its designee.</text> </paragraph> <paragraph num="(3)"> <text>A participating hospital may not bill the Program a charge exceeding that charged the general public for a similar service.</text> </paragraph> <paragraph num="(4)"> <text>The Department may not reimburse the participating hospital for:</text> <paragraph num="(a)"> <text>Completion of a form or report;</text> </paragraph> <paragraph num="(b)"> <text>A broken or missed appointment;</text> </paragraph> <paragraph num="(c)"> <text>A professional service rendered by mail or telephone; or</text> </paragraph> <paragraph num="(d)"> <text>A service which is provided at no charge to the general public.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Department may not make direct payment to an eligible patient.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Reimbursement Rates.</text> <paragraph num="(1)"> <text>A participating hospital located in Maryland shall be reimbursed by the Department:</text> <paragraph num="(a)"> <text>Pursuant to COMAR 10.09.92.07A(2)—(4) and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service;</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(c)"> <text>For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed service, the outstanding deductible and patient contribution amount required by the insurer.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A participating hospital located in a state bordering Maryland shall be reimbursed by the Department:</text> <paragraph num="(a)"> <text>Pursuant to COMAR 10.09.92.07B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service;</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(c)"> <text>For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible and patient contribution amount required by the insurer.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A participating hospital located in the District of Columbia shall be reimbursed by the Department:</text> <paragraph num="(a)"> <text>Pursuant to COMAR 10.09.92.08A and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service;</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(c)"> <text>For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible, and patient contribution required by the insurer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Disposable Medical Supplies and Durable Medical Equipment."> <paragraph num="A."> <text>To be considered a participating medical supply company in the Program, the provider of disposable medical supplies and durable medical equipment shall:</text> <paragraph num="(1)"> <text>To the extent required by law, be licensed and legally authorized to practice or deliver services in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Agree to accept, as payment in full, the amount paid by the Department pursuant to §F of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount;</text> </paragraph> <paragraph num="(4)"> <text>Agree not to bill an eligible patient for an additional charge for the eligible disposable medical supplies and eligible durable medical equipment other than the patient contribution amount, excluding the deductible; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall reimburse for the following:</text> <paragraph num="(1)"> <text>Eligible disposable medical supplies, including but not limited to:</text> <paragraph num="(a)"> <text>Central catheter for administration of intravenous solutions;</text> </paragraph> <paragraph num="(b)"> <text>Administration set for intravenous medication;</text> </paragraph> <paragraph num="(c)"> <text>Parenteral feeding equipment, as follows:</text> <paragraph num="(i)"> <text>Administration set;</text> </paragraph> <paragraph num="(ii)"> <text>Dravon clamp;</text> </paragraph> <paragraph num="(iii)"> <text>Filter; and</text> </paragraph> <paragraph num="(iv)"> <text>Injection cap; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Enteral feeding equipment, as follows:</text> <paragraph num="(i)"> <text>Adapter;</text> </paragraph> <paragraph num="(ii)"> <text>Administration set;</text> </paragraph> <paragraph num="(iii)"> <text>Feeding syringe; and</text> </paragraph> <paragraph num="(iv)"> <text>Nasogastric tube;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Eligible durable medical equipment for purchase or rental, including but not limited to:</text> <paragraph num="(a)"> <text>A delivery system comprised of a pump and pole assembly for an enteral or parenteral feeding;</text> </paragraph> <paragraph num="(b)"> <text>An individually form-fitted arm support stocking for a recipient prescribed by the participating physician as medically necessary, not to exceed two stockings at one time or three stockings in a 12-month period for a non-institutionalized individual;</text> </paragraph> <paragraph num="(c)"> <text>IV pole for use with parenteral administration of medication;</text> </paragraph> <paragraph num="(d)"> <text>External ambulatory infusion pump with administrative equipment, when the usual and customary mode of therapy has been tried and shown to be unsuccessful or impractical;</text> </paragraph> <paragraph num="(e)"> <text>Breast prosthesis, including surgical brassiere; and</text> </paragraph> <paragraph num="(f)"> <text>A wig when the following conditions are met:</text> <paragraph num="(i)"> <text>Hair loss is a direct result of the administration of chemotherapy or radiation for the treatment of breast or cervical cancer;</text> </paragraph> <paragraph num="(ii)"> <text>The cost does not exceed $350; and</text> </paragraph> <paragraph num="(iii)"> <text>The wig is prescribed by an oncologist.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may not reimburse for the following:</text> <paragraph num="(1)"> <text>A disposable medical supply which is not directly related to the diagnosis and treatment of breast cancer or cervical cancer; and</text> </paragraph> <paragraph num="(2)"> <text>Durable medical equipment as follows:</text> <paragraph num="(a)"> <text>Head covering; and</text> </paragraph> <paragraph num="(b)"> <text>An item not directly related to the diagnosis and treatment of breast cancer or cervical cancer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Preauthorization is required for the disposable medical supply and durable medical equipment pursuant to COMAR 10.09.12.06A—F and H.</text> </paragraph> <paragraph num="E."> <text>Reimbursement Procedures. The participating medical supply company:</text> <paragraph num="(1)"> <text>Shall submit the request for payment for the reimbursed service on the form designated by the Department within 12 months of the date of service as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating medical supply company shall send the Department the bill for the service, with a denial from the patient’s insurance carrier; or</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating medical supply company shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance for the service; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible, patient contribution amount, and if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>May not bill the Program a charge exceeding the usual and customary charge to the general public for a similar item; and</text> </paragraph> <paragraph num="(3)"> <text>Shall bill the Program the usual and customary charge for the prosthetic device and an individually form-fitted arm support stocking including:</text> <paragraph num="(a)"> <text>Fitting;</text> </paragraph> <paragraph num="(b)"> <text>Dispensing; and</text> </paragraph> <paragraph num="(c)"> <text>Follow-up care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Reimbursement Procedures.</text> <paragraph num="(1)"> <text>The Department shall reimburse the participating medical supply company:</text> <paragraph num="(a)"> <text>Pursuant to COMAR 10.09.12.07F—K for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service;</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to COMAR 10.09.12.07R and S for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(c)"> <text>The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not reimburse for:</text> <paragraph num="(a)"> <text>Completion of a form;</text> </paragraph> <paragraph num="(b)"> <text>A broken or missed appointment;</text> </paragraph> <paragraph num="(c)"> <text>A professional service rendered by mail or telephone; or</text> </paragraph> <paragraph num="(d)"> <text>A service rendered to the general public at no charge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Home Health Services."> <paragraph num="A."> <text>To be considered a participating home health services provider in the Program, the provider of home health services shall:</text> <paragraph num="(1)"> <text>Be a home health services provider licensed in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation and apply for participation in the Program by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Comply with COMAR 10.09.04.03A, B(2),(3), C(4), and D, if offering skilled nursing care;</text> </paragraph> <paragraph num="(4)"> <text>Accept, as payment in full for covered services rendered, the amount paid by the Program pursuant to §D of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount, and agree not to bill an eligible patient an additional charge for the covered services; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain the patient care, medical supply, billing, and the patient contribution amount records for a minimum of 6 years and, upon request, allow the Department access to the records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall reimburse for a service listed in §C of this regulation when the service is:</text> <paragraph num="(1)"> <text>Provided upon the written order of the participating physician and furnished under the current plan of treatment;</text> </paragraph> <paragraph num="(2)"> <text>Rendered to an eligible patient who is certified by the participating physician as homebound;</text> </paragraph> <paragraph num="(3)"> <text>Consistent with the current diagnosis and treatment of the patient condition;</text> </paragraph> <paragraph num="(4)"> <text>In accordance with accepted standards of practice;</text> </paragraph> <paragraph num="(5)"> <text>Required by the medical condition rather than the convenience or preference of the patient;</text> </paragraph> <paragraph num="(6)"> <text>Considered under accepted standards of practice to be a specific and effective treatment for the condition;</text> </paragraph> <paragraph num="(7)"> <text>Required on a part-time, intermittent basis;</text> </paragraph> <paragraph num="(8)"> <text>Rendered in the home of the eligible patient by a participating home health services provider;</text> </paragraph> <paragraph num="(9)"> <text>Adequately described in the signed and dated progress note; and</text> </paragraph> <paragraph num="(10)"> <text>Directly related to the diagnosis and treatment of breast cancer or cervical cancer.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program provides reimbursement for the following:</text> <paragraph num="(1)"> <text>Skilled nursing care provided by a licensed nurse when the complexity of the service requires the judgment, knowledge, and skill of a licensed nurse;</text> </paragraph> <paragraph num="(2)"> <text>Physical therapy, provided by a licensed physical therapist as specified in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Occupational therapy provided by a licensed occupational therapist as specified in Regulation .14 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Medical supplies and equipment as specified in Regulation .10B of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Other supplies which are used during a reimbursed home health visit as part of the treatment ordered by the participating physician.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Program does not reimburse for services:</text> <paragraph num="(1)"> <text>Not directly related to the treatment of breast and cervical cancer; and</text> </paragraph> <paragraph num="(2)"> <text>Pursuant to COMAR 10.09.04.05A, B, D, G, N, and P;</text> </paragraph> <paragraph num="(3)"> <text>Rendered by Home Health Aides; and</text> </paragraph> <paragraph num="(4)"> <text>Rendered by social workers.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The participating home health services provider is responsible for:</text> <paragraph num="(1)"> <text>Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service, as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for a reimbursed service, the participating home health services provider shall send the Department the bill for the service; or</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating home health services provider shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance for the procedure or service; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible and patient contribution amount; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Not billing the Department under this Program a charge in excess of that charged the general public for a similar service or for a service rendered at no charge to the general public.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Reimbursement Rates. A non-hospital-based participating home health services provider located in Maryland, or a participating home health services provider located in a jurisdiction bordering Maryland shall be reimbursed by the Department:</text> <paragraph num="(1)"> <text>Pursuant to COMAR 10.09.04.07D for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursement service; and</text> </paragraph> <paragraph num="(2)"> <text>For the outstanding deductible and patient contribution amount, if applicable, for an eligible patient who is covered by Medicare or other insurance.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Medical Laboratory Services."> <paragraph num="A."> <text>To be considered a participating medical laboratory in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to:</text> <paragraph num="(a)"> <text>Requirements for Medicare certification;</text> </paragraph> <paragraph num="(b)"> <text>Compliance with the requirements pursuant to COMAR 10.10.03.01 if operating in Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Requirements for the Federal Clinical Laboratory Improvement Act of 1988, 42 U.S.C. §263a;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Agree to accept as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount;</text> </paragraph> <paragraph num="(3)"> <text>Agree not to bill an eligible patient for an additional charge for the medical laboratory services provided;</text> </paragraph> <paragraph num="(4)"> <text>Abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(5)"> <text>Place no restriction on the eligible patient's right to select a provider; and</text> </paragraph> <paragraph num="(6)"> <text>Maintain records adequate to substantiate the ordering, performance, and reporting of laboratory procedures performed or referred for a minimum of 6 years, and, upon request, allow the Department access to the records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A reimbursed service includes but is not limited to the following:</text> <paragraph num="(1)"> <text>Preparation, analysis, and interpretation of a cervical biopsy, endometrial biopsy, vaginal biopsy, and breast biopsy; and</text> </paragraph> <paragraph num="(2)"> <text>A laboratory procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A non-reimbursed service includes but is not limited to the following:</text> <paragraph num="(1)"> <text>A laboratory service not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion;</text> </paragraph> <paragraph num="(2)"> <text>A service for which there does not exist an order signed by a participating health care provider;</text> </paragraph> <paragraph num="(3)"> <text>A procedure for which the laboratory has not been certified by Medicare;</text> </paragraph> <paragraph num="(4)"> <text>A service not provided according to the laws and regulations of the jurisdiction in which the service is rendered;</text> </paragraph> <paragraph num="(5)"> <text>A procedure that is investigational or experimental in nature; and</text> </paragraph> <paragraph num="(6)"> <text>A service included and paid for by the Program as part of the total charge submitted by an inpatient facility or hospital outpatient department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reimbursement Procedures. The participating medical laboratory is responsible for:</text> <paragraph num="(1)"> <text>Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating medical laboratory shall send the bill to the Department; or</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating medical laboratory shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance for the service; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible and patient contribution amount; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Keeping in the records, for each invoice, a copy of the signed orders from a participating health care provider requesting the service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment Procedures.</text> <paragraph num="(1)"> <text>The Department shall pay the participating medical laboratory for a reimbursed service:</text> <paragraph num="(a)"> <text>Pursuant to COMAR 10.09.09.07E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; or</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to COMAR 10.09.09.07F and G(1) and 100 percent of co-insurance for an approved procedure for an eligible patient who is covered by Medicare.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not reimburse for:</text> <paragraph num="(a)"> <text>Completion of a form or report;</text> </paragraph> <paragraph num="(b)"> <text>A broken or missed appointment; and</text> </paragraph> <paragraph num="(c)"> <text>A service which is normally provided at no charge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Freestanding Ambulatory Surgical Center Services."> <paragraph num="A."> <text>To be considered a participating freestanding ambulatory surgical center in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be Medicare certified to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Comply with COMAR 10.09.42.02 and .03B;</text> </paragraph> <paragraph num="(3)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;</text> </paragraph> <paragraph num="(4)"> <text>Agree to accept, as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount;</text> </paragraph> <paragraph num="(5)"> <text>Agree not to bill an eligible patient, who is either uninsured or who is insured with Medicare only, for the reimbursed service;</text> </paragraph> <paragraph num="(6)"> <text>Agree not to bill an eligible patient, who has insurance coverage other than Medicare only, for an additional charge for the reimbursed service other than the patient contribution amount;</text> </paragraph> <paragraph num="(7)"> <text>Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records; and</text> </paragraph> <paragraph num="(8)"> <text>Agree to the medical requirements of the Program pursuant to Regulation .04A(8)—(10) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall reimburse a participating freestanding ambulatory surgical center for a service when the service:</text> <paragraph num="(1)"> <text>Complies with COMAR 10.09.42.04; and</text> </paragraph> <paragraph num="(2)"> <text>Is directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to, the following:</text> <paragraph num="(a)"> <text>Breast biopsy;</text> </paragraph> <paragraph num="(b)"> <text>Conization;</text> </paragraph> <paragraph num="(c)"> <text>Dilation and curettage;</text> </paragraph> <paragraph num="(d)"> <text>Laser treatment;</text> </paragraph> <paragraph num="(e)"> <text>Mastotomy; and</text> </paragraph> <paragraph num="(f)"> <text>Simple or partial mastectomy excluding modified radical mastectomy and radical mastectomy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Program does not reimburse for the following:</text> <paragraph num="(1)"> <text>A service that is not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; and</text> </paragraph> <paragraph num="(2)"> <text>A service or procedure pursuant to COMAR 10.09.42.05.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A participating freestanding ambulatory surgical center shall:</text> <paragraph num="(1)"> <text>Accept and perform the responsibilities pursuant to Regulation .04E(1)—(7) and (9) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Submit a bill for the reimbursed service provided for an eligible patient on the form designated by the Department within 12 months of the date of service as follows:</text> <paragraph num="(a)"> <text>If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating freestanding ambulatory surgical center shall send the bill to the Department; or</text> </paragraph> <paragraph num="(b)"> <text>If an eligible patient is covered by Medicare or other insurance, the participating freestanding ambulatory surgical center shall bill:</text> <paragraph num="(i)"> <text>Medicare or the other insurance the composite rate for the service or procedure performed; and</text> </paragraph> <paragraph num="(ii)"> <text>The Department for the outstanding deductible and patient contribution amount.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall pay the participating freestanding ambulatory surgical center for a reimbursed service:</text> <paragraph num="(1)"> <text>Pursuant to COMAR 10.09.42.06A, B, D, and E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service;</text> </paragraph> <paragraph num="(2)"> <text>Pursuant to COMAR 10.09.42.06F for an eligible patient who is covered by Medicare; or</text> </paragraph> <paragraph num="(3)"> <text>The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Occupational Therapy Services."> <paragraph num="A."> <text>To be considered a participating occupational therapist in the Program, the provider shall:</text> <paragraph num="(1)"> <text>Be an occupational therapist licensed to practice occupational therapy in Maryland or a jurisdiction bordering Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated departmental form;</text> </paragraph> <paragraph num="(3)"> <text>Follow standard health and safety procedures to protect an eligible patient from potential hazards;</text> </paragraph> <paragraph num="(4)"> <text>Agree to requirements of the Program set forth in Regulation .04A(5), (9), and (10) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Agree to accept as payment in full the amount paid by the Program under §E of this regulation, plus the amount paid by the eligible patient's health insurer, if applicable; and</text> </paragraph> <paragraph num="(6)"> <text>Agree not to bill an eligible patient an additional charge for the service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The cost of an occupational therapist’s services are covered as set forth in COMAR 10.09.04.04B(4).</text> </paragraph> <paragraph num="C."> <text>The Program does not reimburse for services:</text> <paragraph num="(1)"> <text>Performed by an occupational therapy assistant if not under the direct supervision of a licensed occupational therapist;</text> </paragraph> <paragraph num="(2)"> <text>Performed by an occupational therapy aide; or</text> </paragraph> <paragraph num="(3)"> <text>Not directly related to the treatment of breast or cervical cancer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The participating occupational therapist is responsible for the following:</text> <paragraph num="(1)"> <text>Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form;</text> </paragraph> <paragraph num="(2)"> <text>Certifying on the invoice that a treatment order is on file and was in effect at the time services were rendered; and</text> </paragraph> <paragraph num="(3)"> <text>Specifying on the invoice the type of treatment provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reimbursement Principles.</text> <paragraph num="(1)"> <text>The Department shall reimburse the participating occupational therapist:</text> <paragraph num="(a)"> <text>For a covered service performed in the provider’s office the amount of:</text> <paragraph num="(i)"> <text>The current Medical Assistance approved rate for the State for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service; or</text> </paragraph> <paragraph num="(ii)"> <text>The outstanding deductible and patient contribution for an eligible patient who is covered by Medicare or other insurance; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For covered services performed in the home of an eligible patient under Regulation .11F of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not reimburse the participating occupational therapist for:</text> <paragraph num="(a)"> <text>Services rendered by mail or telephone;</text> </paragraph> <paragraph num="(b)"> <text>Completion of a form or report;</text> </paragraph> <paragraph num="(c)"> <text>A broken or missed appointment; or</text> </paragraph> <paragraph num="(d)"> <text>A service which is provided at no charge to the general public.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The participating occupational therapist shall obtain recovery under Regulation .17 of this chapter.</text> </paragraph> <paragraph num="G."> <text>The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Medical Management Fee."> <paragraph num="A."> <text>A participating health care provider eligible to receive a medical management fee may be one of the following:</text> <paragraph num="(1)"> <text>Anesthesiologist;</text> </paragraph> <paragraph num="(2)"> <text>Certified nurse midwife;</text> </paragraph> <paragraph num="(3)"> <text>Family practitioner;</text> </paragraph> <paragraph num="(4)"> <text>Gynecologist;</text> </paragraph> <paragraph num="(5)"> <text>Medical internist;</text> </paragraph> <paragraph num="(6)"> <text>Medical oncologist;</text> </paragraph> <paragraph num="(7)"> <text>Nurse anesthetist;</text> </paragraph> <paragraph num="(8)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(9)"> <text>Pathologist;</text> </paragraph> <paragraph num="(10)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(11)"> <text>Radiation oncologist;</text> </paragraph> <paragraph num="(12)"> <text>Radiologist;</text> </paragraph> <paragraph num="(13)"> <text>Surgeon; and</text> </paragraph> <paragraph num="(14)"> <text>Participating health care provider who renders services pursuant to §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall reimburse a participating health care provider as outlined in §A of this regulation a medical management fee of $50 each time a reimbursed service:</text> <paragraph num="(1)"> <text>Is in compliance with the medical guidelines pursuant to Regulation .04A(7)(a)—(f) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Involves a consult with an oncologist pursuant to Regulation .04A(7)(g) and (h) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Is in compliance with the medical care management guidelines pursuant to Regulation .04A(6) of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>Is billed with the medical management fee for reporting and includes a copy of the relevant medical report including, but not limited to:</text> <paragraph num="(a)"> <text>Radiology;</text> </paragraph> <paragraph num="(b)"> <text>Biopsy;</text> </paragraph> <paragraph num="(c)"> <text>Operative; or</text> </paragraph> <paragraph num="(d)"> <text>Staging.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Department, Local Health Department, Hospital, and Health Care Provider Responsibilities."> <paragraph num="A."> <text>The Department is responsible for the following:</text> <paragraph num="(1)"> <text>Developing the necessary administrative forms needed for the Program including, but not limited to, a:</text> <paragraph num="(a)"> <text>Standard application form to determine eligibility of patients;</text> </paragraph> <paragraph num="(b)"> <text>Release of patient information form; and</text> </paragraph> <paragraph num="(c)"> <text>Participating health care provider agreement form;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Distributing the administrative forms to the following:</text> <paragraph num="(a)"> <text>Freestanding ambulatory surgical center;</text> </paragraph> <paragraph num="(b)"> <text>Home health services provider;</text> </paragraph> <paragraph num="(c)"> <text>Certified nurse midwife;</text> </paragraph> <paragraph num="(d)"> <text>Hospital;</text> </paragraph> <paragraph num="(e)"> <text>Occupational therapist;</text> </paragraph> <paragraph num="(f)"> <text>Local health department;</text> </paragraph> <paragraph num="(g)"> <text>Medical laboratory;</text> </paragraph> <paragraph num="(h)"> <text>Medical supply company;</text> </paragraph> <paragraph num="(i)"> <text>Nurse anesthetist;</text> </paragraph> <paragraph num="(j)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(k)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(l)"> <text>Physical therapist;</text> </paragraph> <paragraph num="(m)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(n)"> <text>Physician provider; and</text> </paragraph> <paragraph num="(o)"> <text>Other appropriate health care providers;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providing upon request a list of participating health care providers to local health department coordinators and health care providers for referral of eligible patients;</text> </paragraph> <paragraph num="(4)"> <text>Updating the list of participating health care providers not less than once a year;</text> </paragraph> <paragraph num="(5)"> <text>Reviewing and reimbursing a bill submitted by a participating physician for the reimbursed medical procedure and service using the payment guidelines specified in Regulations .04E(5) and .15 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Reviewing and reimbursing a bill submitted by a participating physician assistant using the payment guidelines specified in Regulations .04-1 and .15 of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Reviewing and reimbursing a bill submitted by a participating certified nurse midwife using the payment guidelines specified in Regulations .04-2 and .15 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Reviewing and reimbursing a bill submitted by a participating nurse practitioner using the payment guidelines specified in Regulations .05 and .15 of this chapter;</text> </paragraph> <paragraph num="(9)"> <text>Reviewing and reimbursing a bill submitted by a participating nurse anesthetist using the payment guidelines specified in Regulations .06 and .15 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Reviewing and reimbursing a bill submitted by a participating physical therapist using the payment guidelines specified in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(11)"> <text>Developing a list of reimbursed medications and pharmacy services;</text> </paragraph> <paragraph num="(12)"> <text>Updating the medication and pharmacy service list at least annually;</text> </paragraph> <paragraph num="(13)"> <text>Developing and providing information to the pharmacy;</text> </paragraph> <paragraph num="(14)"> <text>Reviewing and paying a bill submitted by a participating pharmacy for reimbursed medication, pharmacy service, durable medical equipment, and disposable medical supplies according to Regulation .08E of this chapter;</text> </paragraph> <paragraph num="(15)"> <text>Reviewing and paying a disposable medical supply and durable medical equipment bill and the required deductible, if applicable, according to Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(16)"> <text>Receiving the application for an eligible patient from the local health department, hospital, or health care provider;</text> </paragraph> <paragraph num="(17)"> <text>Developing and issuing to an eligible patient a letter identifying the patient as a participant in the Program;</text> </paragraph> <paragraph num="(18)"> <text>Reviewing and reimbursing a bill submitted by a participating home health services provider using the payment guidelines specified in Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(19)"> <text>Reviewing and reimbursing a bill submitted by a participating medical laboratory using the payment guidelines specified in Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(20)"> <text>Reviewing and reimbursing a bill submitted by a participating freestanding ambulatory surgical center using the payment guidelines specified in Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(21)"> <text>Reviewing and reimbursing a bill submitted by an occupational therapist using the payment guidelines specified in Regulation .14 of this chapter;</text> </paragraph> <paragraph num="(22)"> <text>Reviewing and reimbursing in accordance with Regulation .22 of this chapter a bill submitted by:</text> <paragraph num="(a)"> <text>MHIP or an insurer under contract with MHIP; or</text> </paragraph> <paragraph num="(b)"> <text>A participating health care provider; and</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>Ensuring compliance with the applicable regulations within this chapter by performing a periodic review of the records of a:</text> <paragraph num="(a)"> <text>Hospital; and</text> </paragraph> <paragraph num="(b)"> <text>Participating health care provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The local health department, hospital, and a health care provider who refers a patient to the Program, are responsible for the following:</text> <paragraph num="(1)"> <text>Identifying potentially eligible patients;</text> </paragraph> <paragraph num="(2)"> <text>Assisting the applicant in completing the application form;</text> </paragraph> <paragraph num="(3)"> <text>Collecting the completed application form;</text> </paragraph> <paragraph num="(4)"> <text>Collecting verifying documentation from the applicant, including, but not limited to, proof of residency;</text> </paragraph> <paragraph num="(5)"> <text>Determining eligibility of the applicant using the general, medical, health insurance, and financial criteria specified in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Assisting an eligible patient in selecting a participating health care provider and assisting in scheduling an appointment with the participating health care provider for the reimbursed medical procedure or service;</text> </paragraph> <paragraph num="(7)"> <text>Having an eligible patient sign a release of information form;</text> </paragraph> <paragraph num="(8)"> <text>Providing an eligible patient with a copy of a temporary referral letter, identifying the patient as a participant in the Program, to be given to the participating health care provider until the card is issued to the eligible patient by the Department;</text> </paragraph> <paragraph num="(9)"> <text>Sending the original application with verifying information to the Department; and</text> </paragraph> <paragraph num="(10)"> <text>Evaluating patient progress through follow-up contact with the patient and the participating health care provider.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an additional diagnostic or treatment procedure is necessary, the local health department, hospital, or health care provider who determines patient eligibility and refers an eligible patient to the Program shall repeat the procedure as set forth in §B(6) of this regulation.</text> </paragraph> <paragraph num="D."> <text>The local health department, hospital, or other health care provider who determines patient eligibility and refers an eligible patient to the Program shall document in the patient’s medical record the result of the reimbursed diagnostic and treatment procedure performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Reimbursement."> <paragraph num="A."> <text>The Department shall reimburse a participating health care provider only for a medical service or procedure related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion for an eligible patient.</text> </paragraph> <paragraph num="B."> <text>The Department shall reimburse a participating health care provider a medical management fee pursuant to Regulation .15 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The participating health care provider shall reimburse the Department for an overpayment.</text> </paragraph> <paragraph num="D."> <text>Insurance or Other Coverage.</text> <paragraph num="(1)"> <text>If the patient has insurance or other coverage, the participating health care provider shall first seek payment from that source.</text> </paragraph> <paragraph num="(2)"> <text>The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice.</text> </paragraph> <paragraph num="(3)"> <text>If the insurance carrier provides coverage for a reimbursable procedure or service, the Department shall pay the deductible and patient contribution amount.</text> </paragraph> <paragraph num="(4)"> <text>If an insurance carrier rejects the claim or pays less than the amount of the allowed Medical Assistance Program rate, the provider may submit a claim to the Department.</text> </paragraph> <paragraph num="(5)"> <text>The Department shall pay the difference between what was paid by the insurance carrier and the maximum allowable Medical Assistance Program rate.</text> </paragraph> <paragraph num="(6)"> <text>If payment is made by both the Department and the insurance carrier or other source for the same service, the provider shall refund to the Department within 60 days of receipt the amount paid by the Department, or the Department may recoup those funds.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may not make a direct payment to the eligible patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Liability."> <text>Responsibility for liability for services provided, and for the availability of appropriate insurance coverage, rests with the participating health care provider.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Termination from the Program."> <paragraph num="A."> <text>If the Department determines that a participating health care provider has failed to comply with the applicable regulations of this chapter, the Department may terminate the written agreement with the provider by giving 30 days notice in writing to the participating health care provider.</text> </paragraph> <paragraph num="B."> <text>The participating health care provider may terminate the provider agreement with the Department by:</text> <paragraph num="(1)"> <text>Giving 30 days notice in writing to the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Notifying eligible patients, for whom services have not been provided, of the provider's withdrawal from the Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Appeal Procedures."> <paragraph num="A."> <text>A provider filing an appeal of the Department’s decision to terminate the provider’s agreement with the Program shall do so according to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A provider shall file an appeal within 30 days of receipt of written notice of termination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Billing and Reimbursement Time Limitations."> <paragraph num="A."> <text>The Program may not reimburse claims received for payment more than 12 months after the date of service except as specified in §§B—D of this regulation.</text> </paragraph> <paragraph num="B."> <text>To obtain reimbursement from the Program, a health care provider that originally submits a claim to Medicare or another health insurer shall also submit the claim to the Program within a period whereby the Program receives the claim within the latter of:</text> <paragraph num="(1)"> <text>12 months after the date of service; or</text> </paragraph> <paragraph num="(2)"> <text>6 months from the Medicare or other health insurer remittance date as shown on the explanation of benefits.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program shall pay a claim that is originally rejected for payment due to improper completion or incomplete information only if:</text> <paragraph num="(1)"> <text>The health care provider properly completes and resubmits the claim to the Program; and</text> </paragraph> <paragraph num="(2)"> <text>The Program receives the resubmitted claim within the latter of:</text> <paragraph num="(a)"> <text>The original 12 month period from the date of service; or</text> </paragraph> <paragraph num="(b)"> <text>6 months after claim rejection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>When the Program initially rejects a claim for payment in error, the Program shall pay the claim if the participating health care provider resubmits the claim and the resubmitted claim is received by the Program within the same period specified in §C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Maryland Health Insurance Plan Coverage."> <paragraph num="A."> <text>In lieu of providing direct reimbursement to participating health care providers, the Program may pay MHIP, if available, to provide health coverage for individuals enrolled in the Program who are also eligible for MHIP.</text> </paragraph> <paragraph num="B."> <text>The Program may pay MHIP, if available, for health coverage for eligible patients, including:</text> <paragraph num="(1)"> <text>MHIP premiums;</text> </paragraph> <paragraph num="(2)"> <text>Pre-existing condition buy-downs; and</text> </paragraph> <paragraph num="(3)"> <text>Any MHIP fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program may not pay any amount to MHIP, if available, for an eligible patient’s spouse, children, or other family members enrolled in MHIP.</text> </paragraph> <paragraph num="D."> <text>Fees Reimbursable to Participating Providers.</text> <paragraph num="(1)"> <text>The Program may reimburse participating health care providers for a bill the provider submits to the Department for patient contribution amounts and deductibles for services directly related to the treatment of breast and cervical cancer for individuals enrolled in MHIP through the Program, if funding is available for the payment of patient contribution amounts and deductibles under this section.</text> </paragraph> <paragraph num="(2)"> <text>The Program's decision regarding whether to pay for patient contribution amounts and deductibles shall be based solely on the availability of funding and may not be contingent upon any other factor.</text> </paragraph> <paragraph num="(3)"> <text>If MHIP does not provide coverage for a service covered by this chapter, the Program shall reimburse the participating health care provider as otherwise provided by this chapter.</text> </paragraph> <paragraph num="(4)"> <text>To obtain reimbursement, the participating health care provider shall submit to the Program:</text> <paragraph num="(a)"> <text>The bill for the service on the form designated by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>A copy of the explanation of benefits or denial from MHIP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Payment to MHIP.</text> <paragraph num="(1)"> <text>The Department shall submit timely payments to MHIP for premiums, pre-existing condition buy-downs, and any MHIP fees for individuals enrolled in MHIP through the Program.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall work with the designated MHIP staff to assure timely payments of MHIP invoices for individuals enrolled in MHIP through the Program to:</text> <paragraph num="(a)"> <text>Preserve MHIP coverage; and</text> </paragraph> <paragraph num="(b)"> <text>Resolve any existing issues related to the payment of MHIP premiums.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Funding Availability."> <text>Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-102, 2-104, and 2-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 under new Chapter, Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment, adopted as an emergency provision effective March 31, 1993 (20:8 Md. R. 715); Regulations .03 and .10 amended as an emergency provision effective May 24, 1993 (20:12 Md. R. 995); amendments to Regulation .10 expired June 30, 1993; adopted permanently effective September 13, 1993 (20:18 Md. R. 1430)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new Regulations .01—.20 adopted effective December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H, I adopted as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; adopted permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J adopted effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); revised permanently effective April 19, 2010 (37:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, G amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, E amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 2, 2018 (45:13 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521); May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 adopted effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 20, 2012 (39:16 Md. R. 1080); July 2, 2018 (45:13 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, D amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 2, 2018 (45:13 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C, G amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C, D amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A, E amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A, B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17D amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A, B amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A, D amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> </annotations> </chapter> <chapter num="03" heading="Breast Cancer Treatment Methods"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen.</text> </paragraph> <paragraph num="(3)"> <text>“Treating physician” means an individual authorized under the Medical Practice Act to practice medicine in Maryland who, in Maryland, treats a patient for breast cancer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for the Maryland Department of Health."> <paragraph num="A."> <text>The Department shall provide a standardized written summary in layman's language that:</text> <paragraph num="(1)"> <text>Lists effective methods of treating breast cancer that may be medically practicable including all types of surgical treatment and radiological, hormonal, and chemotherapeutic treatment and combinations of these treatments; and</text> </paragraph> <paragraph num="(2)"> <text>Describes the advantages, disadvantages, risks, and procedures associated with each method of treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall update the standardized written summary annually.</text> </paragraph> <paragraph num="C."> <text>The Department shall provide a statement indicating acknowledgement of receipt of the standardized written summary to be signed by the patient.</text> </paragraph> <paragraph num="D."> <text>The Department shall distribute copies of the standardized written summary and the acknowledgement of receipt statement to all hospitals, clinics, other facilities, and physicians' offices where treatment of breast cancer is performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements of Treating Physicians."> <paragraph num="A."> <text>At any time before, but not more than 5 days after, a treating physician informs a patient of a diagnosis of breast cancer, and before treatment, the treating physician shall give the patient:</text> <paragraph num="(1)"> <text>The standardized written summary provided by the Department; or</text> </paragraph> <paragraph num="(2)"> <text>An equivalent summary including the requirements under Regulation .02A written in language that the patient understands.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A treating physician may not undertake any of the treatments described in Regulation .02A(1) until a breast cancer patient has been given the written summary described in §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="C."> <text>A treating physician who provides a patient with the written summary required under these regulations shall have the patient sign a statement provided by the Department acknowledging receipt of the summary and shall have a copy of this signed acknowledgement placed in the patient's medical record which is used by the treating physician.</text> </paragraph> <paragraph num="D."> <text>The requirements under this regulation do not apply if the:</text> <paragraph num="(1)"> <text>Treating physician certifies in writing in the patient's medical record that one of the treatments for breast cancer described in Regulation .02A(1) occurred within 5 days of the physician informing the patient of the diagnosis; and</text> </paragraph> <paragraph num="(2)"> <text>Treatment within this period of time was necessary to save the life of the patient.</text> </paragraph> </paragraph> <paragraph num="E."> <text>These regulations should not be interpreted to require a waiting period between diagnosis and treatment.</text> </paragraph> <paragraph num="F."> <text>This regulation is supplemental and additional to any other requirements established by other laws upon a treating physician and may not be regarded as in derogation or substitution of any requirements now existing upon a treating physician, such as the need to obtain informed consent for treatment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-113, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 14, 1988 (15:23 Md. R. 2658)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 20, 1992 (19:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.06.05 to COMAR 10.14.03 in July, 1993</annotation> </annotations> </chapter> <chapter num="04" heading="Breast Cancer Program"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter:</text> <paragraph num="(1)"> <text>Establishes the requirements for participating medical providers;</text> </paragraph> <paragraph num="(2)"> <text>Sets criteria for applicant eligibility;</text> </paragraph> <paragraph num="(3)"> <text>Outlines services covered; and</text> </paragraph> <paragraph num="(4)"> <text>Delineates the responsibilities of the Department and local health departments for breast cancer screening, diagnosis, and treatment services under the Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter operates in conjunction with the:</text> <paragraph num="(1)"> <text>Breast and Cervical Cancer Program; and</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, as set forth in COMAR 10.14.02.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter addresses the purpose set forth in Health-General Article, §20-116, Annotated Code of Maryland, by providing the services funded under the Breast Cancer Program through the programs cited in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Annual gross income” means the total amount of income received by the applicant and, if applicable, the applicant's spouse, each year from all sources before taxes are withheld.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who has applied to receive services under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Biennial” means once every other year.</text> </paragraph> <paragraph num="(4)"> <text>“Breast and Cervical Cancer Program” means the program that is:</text> <paragraph num="(a)"> <text>Administered by:</text> <paragraph num="(i)"> <text>A local health department; or</text> </paragraph> <paragraph num="(ii)"> <text>A private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Established for the early detection of breast and cervical cancer; and</text> </paragraph> <paragraph num="(c)"> <text>Funded by:</text> <paragraph num="(i)"> <text>The federal Centers for Disease Control and Prevention;</text> </paragraph> <paragraph num="(ii)"> <text>The Breast Cancer Program under Health-General Article, §20-116, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(iii)"> <text>Both.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Breast Cancer Program” means the program created by Health-General Article, §20-116, Annotated Code of Maryland, to provide:</text> <paragraph num="(a)"> <text>At least biennial screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 40 years old through 49 years old;</text> </paragraph> <paragraph num="(b)"> <text>Annual screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 50 years old or older; and</text> </paragraph> <paragraph num="(c)"> <text>Diagnosis and treatment for individuals who are identified by the Breast Cancer Program as being in need.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Clinical breast examination” means a physical examination of the breast performed by a health care professional for the purpose of detecting breast cancer.</text> </paragraph> <paragraph num="(7)"> <text>“Contract” means the written agreement between a local health department and a health care provider for the provision of breast cancer services.</text> </paragraph> <paragraph num="(8)"> <text>“Copayment” means the set amount of money that an individual who is enrolled in a health insurance plan is responsible for paying each time the individual receives a medical service after the deductible, if applicable, has been paid.</text> </paragraph> <paragraph num="(9)"> <text>“Deductible” means a specific sum of money that an individual who is enrolled in a health insurance plan is required to pay before the individual's health insurance plan reimburses the individual or the individual's medical provider for covered medical services received.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(11)"> <text>“Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen.</text> </paragraph> <paragraph num="(12)"> <text>“Eligible individual” means an applicant who meets the requirements of Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(13)"> <text>“Enrollee” means an eligible individual who has been accepted into the Breast Cancer Program.</text> </paragraph> <paragraph num="(14)"> <text>“Free-standing ambulatory surgical center” means a facility that:</text> <paragraph num="(a)"> <text>Provides ambulatory surgical services;</text> </paragraph> <paragraph num="(b)"> <text>Is physically separate from a hospital or hospital grounds;</text> </paragraph> <paragraph num="(c)"> <text>Is certified by Medicare to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and</text> </paragraph> <paragraph num="(d)"> <text>Complies with COMAR 10.09.42.02 and .03B.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Home health services provider” means a public or private agency, organization, or part of an agency or organization licensed in Maryland or a jurisdiction bordering Maryland that:</text> <paragraph num="(a)"> <text>Meets one of the following licensure requirements:</text> <paragraph num="(i)"> <text>If the provider is a home health agency located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>If the provider is a home health agency located in a jurisdiction bordering Maryland, the provider is legally authorized to provide home health services under the laws of that jurisdiction;</text> </paragraph> <paragraph num="(iii)"> <text>If the provider is part of a hospital or related institution located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(iv)"> <text>If the provider is an individual who has a contractual agreement with the Department to provide skilled nursing care to eligible individuals, the individual is a nurse who is licensed under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland, to practice registered nursing;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provides nursing or physical therapy services in the home; and</text> </paragraph> <paragraph num="(c)"> <text>Meets the requirements for participation in Medicare.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Hospital” means an institution which is located:</text> <paragraph num="(a)"> <text>In Maryland, that is:</text> <paragraph num="(i)"> <text>Subject to the provisions of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Licensed pursuant to COMAR 10.07.01; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In a jurisdiction bordering Maryland, that is licensed pursuant to applicable standards established by the jurisdiction in which the hospital is located.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Local health department” means a governmental entity that provides public health services on behalf of a county in Maryland or Baltimore City.</text> </paragraph> <paragraph num="(18)"> <text>“Mammogram” means an X-ray examination of the breast to detect breast cancer that uses equipment:</text> <paragraph num="(a)"> <text>Specifically dedicated for mammography, including:</text> <paragraph num="(i)"> <text>X-ray tubes;</text> </paragraph> <paragraph num="(ii)"> <text>Filters;</text> </paragraph> <paragraph num="(iii)"> <text>Compression devices;</text> </paragraph> <paragraph num="(iv)"> <text>Screens;</text> </paragraph> <paragraph num="(v)"> <text>Films; and</text> </paragraph> <paragraph num="(vi)"> <text>Cassettes; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That is designed to deliver an average radiation exposure of less than one rad mid-breast with two views for each breast.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Medical Assistance” means the program that:</text> <paragraph num="(a)"> <text>Provides comprehensive medical and other health-related care for eligible individuals; and</text> </paragraph> <paragraph num="(b)"> <text>Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §1396.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Medical laboratory” means a laboratory that:</text> <paragraph num="(a)"> <text>Examines tissue specimens in connection with the diagnosis, treatment, or control of human disease or the assessment of human health or nutritional or medical conditions; and</text> </paragraph> <paragraph num="(b)"> <text>Is in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to the requirements:</text> <paragraph num="(i)"> <text>For Medicare certification;</text> </paragraph> <paragraph num="(ii)"> <text>Set forth in Health-General Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Set forth in COMAR 10.10.01 — 10.10.08; and</text> </paragraph> <paragraph num="(iv)"> <text>Of the federal Clinical Laboratories Improvement Act, 42 U.S.C. §263a.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Medical supply company” means a provider of disposable medical supplies or durable medical equipment that, to the extent required by law, is licensed and legally authorized to practice or deliver services in Maryland or in a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> <paragraph num="(22)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395.</text> </paragraph> <paragraph num="(23)"> <text>“Nurse anesthetist” means a registered nurse who is:</text> <paragraph num="(a)"> <text>Certified as a nurse anesthetist in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and</text> </paragraph> <paragraph num="(b)"> <text>Currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine:</text> <paragraph num="(i)"> <text>In Maryland as prescribed by COMAR 10.27.06; or</text> </paragraph> <paragraph num="(ii)"> <text>In a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Nurse practitioner” means a registered nurse who is certified:</text> <paragraph num="(a)"> <text>By the Maryland Board of Nursing to engage in the activities specified in COMAR 10.27.07; or</text> </paragraph> <paragraph num="(b)"> <text>As a nurse practitioner in a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Participating medical provider under the Breast and Cervical Cancer Program” means a health care provider who has entered into a written agreement with a local health department or the private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program to provide breast cancer services to an enrollee.</text> </paragraph> <paragraph num="(26)"> <text>“Participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means any of the following:</text> <paragraph num="(a)"> <text>A physician who meets the requirements of COMAR 10.14.02.04A;</text> </paragraph> <paragraph num="(b)"> <text>A nurse practitioner who meets the requirements of COMAR 10.14.02.05A;</text> </paragraph> <paragraph num="(c)"> <text>A nurse anesthetist who meets the requirements of COMAR 10.14.02.06A;</text> </paragraph> <paragraph num="(d)"> <text>A physical therapist who meets the requirements of COMAR 10.14.02.07A;</text> </paragraph> <paragraph num="(e)"> <text>A pharmacy that meets the requirements of COMAR 10.14.02.08A;</text> </paragraph> <paragraph num="(f)"> <text>A hospital that meets the requirements of COMAR 10.14.02.09A;</text> </paragraph> <paragraph num="(g)"> <text>A medical supply company that meets the requirements of COMAR 10.14.02.10A;</text> </paragraph> <paragraph num="(h)"> <text>A home health service provider that meets the requirements of COMAR 10.14.02.11A;</text> </paragraph> <paragraph num="(i)"> <text>A medical laboratory that meets the requirements of COMAR 10.14.02.12A; or</text> </paragraph> <paragraph num="(j)"> <text>A free-standing ambulatory surgical center that meets the requirements of COMAR 10.14.02.13A.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Pharmacy” means an establishment or institution that holds a permit to provide pharmacy services under Health Occupations Article, Title 12, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(28)"> <text>“Physical therapist” means an individual who is licensed or registered to practice physical therapy:</text> <paragraph num="(a)"> <text>In Maryland under Health Occupations Article, Title 13, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Physician” means an individual who is licensed to practice medicine:</text> <paragraph num="(a)"> <text>In Maryland under Health Occupations Article, Title 14, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Recipient of service” means an enrollee who has received a covered service under this chapter.</text> </paragraph> <paragraph num="(31)"> <text>“Registered nurse” means an individual who is licensed to practice registered nursing:</text> <paragraph num="(a)"> <text>In Maryland under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In a jurisdiction bordering Maryland under the laws of that jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means the program operated by the Department to pay for breast and cervical cancer diagnostic and treatment procedures for eligible women under COMAR 10.14.02.</text> </paragraph> <paragraph num="(33)"> <text>“Resident” means an individual who is currently residing in Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Screening” means a medical test to detect cancer.</text> </paragraph> <paragraph num="(35)"> <text>“Surgical consult” means a consultation with a surgeon for advice on the recommended follow-up of the results of screening tests that are not considered normal.</text> </paragraph> <paragraph num="(36)"> <text>“Treatment” means the medical management and care of a patient for breast cancer.</text> </paragraph> <paragraph num="(37)"> <text>“Ultrasound” means a medical test in which high frequency sound waves are used to make an image of a specific area of the breast to determine if a breast lump is a fluid-filled cyst or a solid mass.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Overview of Funding and Delivery of Services."> <paragraph num="A."> <text>The Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland, provides State funding for breast cancer screening, diagnosis, and treatment for eligible individuals under this chapter.</text> </paragraph> <paragraph num="B."> <text>Services funded under the Breast Cancer Program shall be delivered through two previously existing programs as follows:</text> <paragraph num="(1)"> <text>Breast cancer screening and diagnostic services shall be provided to an enrollee through local health departments and private entities that contract with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program; and</text> </paragraph> <paragraph num="(2)"> <text>Breast cancer diagnostic and treatment services shall be provided to an enrollee through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant is eligible for services under the Breast Cancer Program if the applicant meets the eligibility requirements of either Regulation .04 or .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility — Breast and Cervical Cancer Program."> <paragraph num="A."> <text>To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall:</text> <paragraph num="(1)"> <text>Be a resident of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be 40 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Meet the financial eligibility criteria specified in §B of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Meet the health insurance criteria specified in §C of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Be determined to be eligible to receive covered services by a:</text> <paragraph num="(a)"> <text>Local health department or an agency or organization designated by the local health department; or</text> </paragraph> <paragraph num="(b)"> <text>Private entity that contracts with the Department to render services in Baltimore City or Calvert County.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Financial Eligibility Criteria.</text> <paragraph num="(1)"> <text>Financial eligibility under this chapter is based on annual gross income and family size.</text> </paragraph> <paragraph num="(2)"> <text>To be financially eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant may not have an annual gross income that exceeds 250 percent of the most recent federal poverty guidelines updated annually in the Federal Register by the United States Department of Health and Human Services in accordance with 42 U.S.C. §9902(2).</text> </paragraph> <paragraph num="(3)"> <text>For the purposes of determining family size under the federal poverty guidelines set forth at §B(2) of this regulation, the following individuals are family members of the applicant:</text> <paragraph num="(a)"> <text>The applicant;</text> </paragraph> <paragraph num="(b)"> <text>The applicant's spouse;</text> </paragraph> <paragraph num="(c)"> <text>The applicant's financially dependent children; and</text> </paragraph> <paragraph num="(d)"> <text>The applicant's financially dependent relatives.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall meet one of the following health insurance criteria:</text> <paragraph num="(1)"> <text>The applicant is not currently covered by health insurance; or</text> </paragraph> <paragraph num="(2)"> <text>The applicant is currently covered by health insurance that:</text> <paragraph num="(a)"> <text>Does not provide reimbursement for a service covered under this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Requires the applicant to pay a co-pay, co-insurance, or a deductible that has not been met for a service covered under this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant may not receive breast cancer services under this chapter through the Breast and Cervical Cancer Program if:</text> <paragraph num="(1)"> <text>The applicant is enrolled in Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>The applicant is enrolled in a health maintenance organization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility — Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program."> <text>To be eligible to receive breast cancer services under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, an applicant shall meet the eligibility requirements specified in COMAR 10.14.02.03.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Covered Services."> <paragraph num="A."> <text>The following breast cancer services are covered for enrollees under this chapter through the Breast and Cervical Cancer Program:</text> <paragraph num="(1)"> <text>Annual clinical breast examinations;</text> </paragraph> <paragraph num="(2)"> <text>Mammograms that are provided:</text> <paragraph num="(a)"> <text>Annually to enrollees 50 years old or older; and</text> </paragraph> <paragraph num="(b)"> <text>At least on a biennial basis to enrollees 40 years old through 49 years old; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Follow-up clinical breast examinations, mammograms, ultrasounds, and surgical consults as considered medically necessary by the participating medical provider under the Breast and Cervical Cancer Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following breast cancer services are covered for enrollees under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program:</text> <paragraph num="(1)"> <text>A physician's services as described in COMAR 10.14.02.04C;</text> </paragraph> <paragraph num="(2)"> <text>A nurse practitioner's services as described in COMAR 10.14.02.05C;</text> </paragraph> <paragraph num="(3)"> <text>A nurse anesthetist's services as described in COMAR 10.14.02.06C;</text> </paragraph> <paragraph num="(4)"> <text>A physical therapist's services as described in COMAR 10.14.02.07B;</text> </paragraph> <paragraph num="(5)"> <text>A pharmacy's services as described in COMAR 10.14.02.08B;</text> </paragraph> <paragraph num="(6)"> <text>A hospital's services as described in COMAR 10.14.02.09B;</text> </paragraph> <paragraph num="(7)"> <text>A medical supply company's services as described in COMAR 10.14.02.10B;</text> </paragraph> <paragraph num="(8)"> <text>A home health service provider's services as described in COMAR 10.14.02.11B;</text> </paragraph> <paragraph num="(9)"> <text>A medical laboratory's services as described in COMAR 10.14.02.12B; or</text> </paragraph> <paragraph num="(10)"> <text>A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13B.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The following breast cancer services are not covered for enrollees under this chapter:</text> <paragraph num="(1)"> <text>A physician's services as described in COMAR 10.14.02.04D;</text> </paragraph> <paragraph num="(2)"> <text>A nurse practitioner's services as described in COMAR 10.14.02.05D;</text> </paragraph> <paragraph num="(3)"> <text>A nurse anesthetist's services as described in COMAR 10.14.02.06D;</text> </paragraph> <paragraph num="(4)"> <text>A physical therapist's services as described in COMAR 10.14.02.07C;</text> </paragraph> <paragraph num="(5)"> <text>A pharmacy's services as described in COMAR 10.14.02.08C;</text> </paragraph> <paragraph num="(6)"> <text>A hospital's services as described in COMAR 10.14.02.09C;</text> </paragraph> <paragraph num="(7)"> <text>A medical supply company's services as described in COMAR 10.14.02.10C;</text> </paragraph> <paragraph num="(8)"> <text>A home health service provider's services as described in COMAR 10.14.02.11D;</text> </paragraph> <paragraph num="(9)"> <text>A medical laboratory's services as described in COMAR 10.14.02.12C; or</text> </paragraph> <paragraph num="(10)"> <text>A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Responsibilities of the Department."> <text>The Department shall:</text> <paragraph num="A."> <text>Award grants to local health departments and private entities in Baltimore City and Calvert County as specified by Health-General Article, §20-116, Annotated Code of Maryland, for use in providing breast cancer screening services to eligible women under the Breast and Cervical Cancer Program; and</text> </paragraph> <paragraph num="B."> <text>Reimburse a participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program for performing covered breast and cervical cancer diagnosis and treatment services on enrollees, pursuant to funding provided under Health-General Article, §20-116, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsibilities of Local Health Departments and Private Entities."> <paragraph num="A."> <text>A local health department and the private entities in Baltimore City and Calvert County shall:</text> <paragraph num="(1)"> <text>Enter into written agreements with health care providers to provide breast cancer services to enrollees using the contracts developed by the Department for use in the Breast and Cervical Cancer Program;</text> </paragraph> <paragraph num="(2)"> <text>Reimburse a participating medical provider under the Breast and Cervical Cancer Program for performing covered services on enrollees;</text> </paragraph> <paragraph num="(3)"> <text>Determine eligibility of applicants using the criteria specified in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Recruit eligible individuals; and</text> </paragraph> <paragraph num="(5)"> <text>Provide enrollees, recipients of services, and medical providers with assistance in obtaining program-related information and services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to assure the availability of breast cancer diagnostic and treatment services, a local health department shall comply with COMAR 10.14.02.15B.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Funding Availability."> <text>The implementation and ongoing administration of this chapter is contingent upon the availability of funds.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-116, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 10, 2003 (30:22 Md. R. 1581)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> </annotations> </chapter> <chapter num="05" heading="Maryland Cancer Fund"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Defines the Maryland Cancer Fund;</text> </paragraph> <paragraph num="B."> <text>Describes how contributions may be made to the Maryland Cancer Fund;</text> </paragraph> <paragraph num="C."> <text>Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Maryland Cancer Fund;</text> </paragraph> <paragraph num="D."> <text>Identifies eligible applicants; and</text> </paragraph> <paragraph num="E."> <text>Outlines the grant application process for the Maryland Cancer Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Annual family income” means the total amount received per year from all sources before taxes are withheld.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means a person who has applied to receive a grant under the Maryland Cancer Fund.</text> </paragraph> <paragraph num="(3)"> <text>“Applied research” means research that is undertaken to determine:</text> <paragraph num="(a)"> <text>Possible uses for the findings of basic research; or</text> </paragraph> <paragraph num="(b)"> <text>New ways of achieving some specific objective.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Authorized representative” means an individual or organization that has received permission from an individual diagnosed with cancer to perform certain tasks on the individual's behalf.</text> </paragraph> <paragraph num="(5)"> <text>“Basic research” means experimental or theoretical work undertaken to acquire new knowledge or understanding of cancer.</text> </paragraph> <paragraph num="(6)"> <text>“Case management” means the coordination of services by a health care professional for an individual for cancer:</text> <paragraph num="(a)"> <text>Screening;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosis; or</text> </paragraph> <paragraph num="(c)"> <text>Treatment.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Capital expenditures” means money spent to add or expand property, equipment, and assets that will benefit an organization in the long term.</text> </paragraph> <paragraph num="(8)"> <text>"Center for Cancer Prevention and Control (CCPC)" means a unit of the Maryland Department of Health within the Prevention and Health Promotion Administration.</text> </paragraph> <paragraph num="(9)"> <text>“Clinical research” means research:</text> <paragraph num="(a)"> <text>Conducted primarily on patients; and</text> </paragraph> <paragraph num="(b)"> <text>Designed to answer questions about the etiology, prevention, early detection, diagnosis, or treatment of cancer.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Community-based participatory research” means a collaborative, partnership approach to research that equitably involves community members, organizational representatives, and researchers in all aspects of the research process.</text> </paragraph> <paragraph num="(11)"> <text>“Comptroller” means the Comptroller of the Treasury.</text> </paragraph> <paragraph num="(12)"> <text>“Coinsurance” means the percent of allowable charges for a medical service that an individual with health insurance is responsible for paying.</text> </paragraph> <paragraph num="(13)"> <text>“Copayment (copay)” means the set amount of money that an individual with health insurance is responsible for paying each time the individual receives a medical service.</text> </paragraph> <paragraph num="(14)"> <text>“County” means a county of this State or Baltimore City.</text> </paragraph> <paragraph num="(15)"> <text>“Current Procedure Terminology (CPT)” means the uniform descriptive terms and identifying codes for reporting medical services and procedures performed by physicians.</text> </paragraph> <paragraph num="(16)"> <text>“Deductible” means the amount of money that an individual with health insurance is required to pay before the individual's health insurance starts coverage.</text> </paragraph> <paragraph num="(17)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(18)"> <text>“Diagnosis” means a histopathologic finding of cancer in a:</text> <paragraph num="(a)"> <text>Biopsy; or</text> </paragraph> <paragraph num="(b)"> <text>Surgical specimen.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Educational Institution.</text> <paragraph num="(a)"> <text>“Educational institution” means an organization whose primary mission is to educate individuals.</text> </paragraph> <paragraph num="(b)"> <text>“Educational institution” includes:</text> <paragraph num="(i)"> <text>Private and public elementary schools;</text> </paragraph> <paragraph num="(ii)"> <text>Middle schools;</text> </paragraph> <paragraph num="(iii)"> <text>High schools;</text> </paragraph> <paragraph num="(iv)"> <text>Colleges;</text> </paragraph> <paragraph num="(v)"> <text>Universities;</text> </paragraph> <paragraph num="(vi)"> <text>Graduate schools; and</text> </paragraph> <paragraph num="(vii)"> <text>Research institutions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Family” means the unit comprised of all of the following that apply:</text> <paragraph num="(a)"> <text>For a financially independent adult 18 years old or older diagnosed with cancer, the adult diagnosed with cancer or the adult diagnosed with cancer and one or more of the following:</text> <paragraph num="(i)"> <text>Spouse;</text> </paragraph> <paragraph num="(ii)"> <text>Financially dependent child; or</text> </paragraph> <paragraph num="(iii)"> <text>Financially dependent relative; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a financially dependent child, the child and one or more of the following:</text> <paragraph num="(i)"> <text>Parent, foster parent, or guardian;</text> </paragraph> <paragraph num="(ii)"> <text>Sibling living in the household; or</text> </paragraph> <paragraph num="(iii)"> <text>Half brother or half sister living in the household.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services and which are incorporated by reference by COMAR 10.11.03.01–1.</text> </paragraph> <paragraph num="(22)"> <text>“Fund” means the Maryland Cancer Fund.</text> </paragraph> <paragraph num="(23)"> <text>Grant.</text> <paragraph num="(a)"> <text>“Grant” means financial assistance from the State to support an applicant's activities related to cancer:</text> <paragraph num="(i)"> <text>Research;</text> </paragraph> <paragraph num="(ii)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(iii)"> <text>Secondary prevention; and</text> </paragraph> <paragraph num="(iv)"> <text>Treatment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Grant” does not mean a contract.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Governmental entity” means a federal, State, or local governmental organization.</text> </paragraph> <paragraph num="(25)"> <text>“Health Services Cost Review Commission (HSCRC)” means the independent organization within the Department that is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(26)"> <text>“Hospital” means an institution that:</text> <paragraph num="(a)"> <text>Operates within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Laboratory” means a licensed or certified facility operated for the examination of material derived from the human body for the purpose of obtaining information for the diagnosis, treatment, and management of a disease.</text> </paragraph> <paragraph num="(28)"> <text>“Local health department” means a governmental entity in a county in Maryland that provides public health services.</text> </paragraph> <paragraph num="(29)"> <text>“Major medical equipment” means equipment that:</text> <paragraph num="(a)"> <text>Costs in excess of $500; and</text> </paragraph> <paragraph num="(b)"> <text>Is used for the provision of medical or health services.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Maryland Comprehensive Cancer Control Plan” means the most recent edition of the cancer plan developed by the Department.</text> </paragraph> <paragraph num="(31)"> <text>“Maryland Health Insurance Plan (MHIP)” means a State-administered program that:</text> <paragraph num="(a)"> <text>Is operated by a unit within the Maryland Insurance Administration under Insurance Article, Title 14, Subtitle 5, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Provides health insurance coverage to medically uninsurable Maryland residents.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396 — 1396v, which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons.</text> </paragraph> <paragraph num="(33)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 — 1395hhh.</text> </paragraph> <paragraph num="(34)"> <text>“Patient contribution amount” means the amount of money required by an individual’s health insurance policy to be paid by the individual for a given medical procedure or service received, excluding the deductible.</text> </paragraph> <paragraph num="(35)"> <text>“Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided.</text> </paragraph> <paragraph num="(36)"> <text>“Premium” means the amount of money than an individual pays in regular installments to a health insurer for a health insurance policy.</text> </paragraph> <paragraph num="(37)"> <text>Primary Prevention.</text> <paragraph num="(a)"> <text>“Primary prevention” means activities to prevent or reduce the development of cancer.</text> </paragraph> <paragraph num="(b)"> <text>“Primary prevention” includes interventions such as:</text> <paragraph num="(i)"> <text>Tobacco use prevention and cessation;</text> </paragraph> <paragraph num="(ii)"> <text>Protection from ultraviolet light;</text> </paragraph> <paragraph num="(iii)"> <text>Proper nutrition and physical activity; and</text> </paragraph> <paragraph num="(iv)"> <text>Reduction of exposure to environmental and occupational carcinogens.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(38)"> <text>Research.</text> <paragraph num="(a)"> <text>“Research” means activities to develop or advance the understanding of cancer or the techniques or modalities effective in the prevention, cure, screening, diagnosis, or treatment of cancer.</text> </paragraph> <paragraph num="(b)"> <text>“Research” includes basic, clinical, applied, translational, and community-based participatory research.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Secondary prevention” means activities to detect and diagnose cancer in its early stages, when the chances of treatment and control are the greatest.</text> </paragraph> <paragraph num="(40)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(41)"> <text>“Translational research” means using or applying new discoveries to benefit patient care.</text> </paragraph> <paragraph num="(42)"> <text>“Treatment” means the medical management and care of a patient that is provided for:</text> <paragraph num="(a)"> <text>Obtaining a cancer diagnosis, determining the full extent of the cancer spread, or treating the cancer, including:</text> <paragraph num="(i)"> <text>Surgery;</text> </paragraph> <paragraph num="(ii)"> <text>Chemotherapy;</text> </paragraph> <paragraph num="(iii)"> <text>Radiation therapy;</text> </paragraph> <paragraph num="(iv)"> <text>Hormonal therapy;</text> </paragraph> <paragraph num="(v)"> <text>Biopsy;</text> </paragraph> <paragraph num="(vi)"> <text>Imaging procedures;</text> </paragraph> <paragraph num="(vii)"> <text>Laboratory testing;</text> </paragraph> <paragraph num="(viii)"> <text>Home health services; and</text> </paragraph> <paragraph num="(ix)"> <text>Medical supplies or medical equipment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Treating medical complications resulting from cancer screening or treatment;</text> </paragraph> <paragraph num="(c)"> <text>Treating other co-morbid conditions in order to treat cancer; or</text> </paragraph> <paragraph num="(d)"> <text>Providing palliative or end-of-life care.</text> </paragraph> </paragraph> <paragraph num="(43)"> <text>“Uninsured” means that an individual:</text> <paragraph num="(a)"> <text>Does not have any health insurance; or</text> </paragraph> <paragraph num="(b)"> <text>Has health insurance that does not cover the cancer prevention, screening, diagnosis, or treatment services provided under the Fund.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Maryland Cancer Fund."> <paragraph num="A."> <text>The Maryland Cancer Fund is a nonlapsing, special fund created by Health-General Article, §20-117, Annotated Code of Maryland, for cancer research, prevention, and treatment, which is generated from:</text> <paragraph num="(1)"> <text>Contributions from the income tax checkoff system under Tax-General Article, §2-112, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Any other donations to the Fund.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may only expend funds:</text> <paragraph num="(1)"> <text>In accordance with an appropriation approved by the General Assembly in the annual State budget; or</text> </paragraph> <paragraph num="(2)"> <text>Through an approved budget amendment under State Finance and Procurement Article, §§7-209 and 7-210, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may only make grant awards under the Fund for cancer:</text> <paragraph num="(1)"> <text>Research;</text> </paragraph> <paragraph num="(2)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(3)"> <text>Secondary prevention; or</text> </paragraph> <paragraph num="(4)"> <text>Treatment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Any unspent portions of the Fund shall remain in the Fund and may not revert to the General Fund of the State.</text> </paragraph> <paragraph num="E."> <text>Money expended from the Fund is supplemental to, and is not intended to take the place of, funding that would otherwise be appropriated to the Department for cancer:</text> <paragraph num="(1)"> <text>Research;</text> </paragraph> <paragraph num="(2)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(3)"> <text>Secondary prevention; or</text> </paragraph> <paragraph num="(4)"> <text>Treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Contributions to the Maryland Cancer Fund."> <text>An individual or each spouse in the case of a joint income tax return may contribute an amount to the Fund by:</text> <paragraph num="A."> <text>Deducting the amount of the contribution from any refund due under a tax return; or</text> </paragraph> <paragraph num="B."> <text>Adding the amount of the contribution to the income tax to be paid with a tax return.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of the Department."> <text>The Department:</text> <paragraph num="A."> <text>Shall administer the Fund;</text> </paragraph> <paragraph num="B."> <text>May not spend more than 5 percent of the proceeds received from the Comptroller for the Fund to promote further donations to the Fund; and</text> </paragraph> <paragraph num="C."> <text>Shall provide a grant in each fiscal year to persons to conduct one or more of the following cancer-related activities:</text> <paragraph num="(1)"> <text>Research;</text> </paragraph> <paragraph num="(2)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(3)"> <text>Secondary prevention; or</text> </paragraph> <paragraph num="(4)"> <text>Treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Responsibilities of the Comptroller."> <text>The Comptroller shall:</text> <paragraph num="A."> <text>Include in the individual income tax return form:</text> <paragraph num="(1)"> <text>A checkoff designated as the Maryland Cancer Fund contribution; and</text> </paragraph> <paragraph num="(2)"> <text>A description that the Fund may only be used for cancer:</text> <paragraph num="(a)"> <text>Research;</text> </paragraph> <paragraph num="(b)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(c)"> <text>Secondary prevention; or</text> </paragraph> <paragraph num="(d)"> <text>Treatment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Collect the checkoff contributions and other donations and account to the Treasurer for the money collected;</text> </paragraph> <paragraph num="C."> <text>Distribute the amount necessary to administer the checkoff system to an administrative cost account;</text> </paragraph> <paragraph num="D."> <text>After the distribution under §C of this regulation, distribute the remainder of the money to the Fund; and</text> </paragraph> <paragraph num="E."> <text>Notify the Department annually of:</text> <paragraph num="(1)"> <text>The gross amount of donations to the Fund through the income tax checkoff system;</text> </paragraph> <paragraph num="(2)"> <text>The gross amount of other donations to the Fund; and</text> </paragraph> <paragraph num="(3)"> <text>The costs of administration of the income tax checkoff system by the Comptroller.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Persons Eligible For Grants."> <paragraph num="A."> <text>Subject to any limitations imposed under §B of this regulation, the following persons are eligible to receive a grant from the Department for cancer research, primary prevention, secondary prevention, or treatment:</text> <paragraph num="(1)"> <text>Physicians;</text> </paragraph> <paragraph num="(2)"> <text>Hospitals;</text> </paragraph> <paragraph num="(3)"> <text>Laboratories;</text> </paragraph> <paragraph num="(4)"> <text>Educational institutions;</text> </paragraph> <paragraph num="(5)"> <text>Local health departments;</text> </paragraph> <paragraph num="(6)"> <text>Governmental entities; and</text> </paragraph> <paragraph num="(7)"> <text>Another person or organization with expertise in cancer research, primary prevention, secondary prevention, or treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may limit the persons eligible to receive a grant in §A of this regulation based on:</text> <paragraph num="(1)"> <text>Availability of funds; and</text> </paragraph> <paragraph num="(2)"> <text>The Department's ability to account for and monitor the grant funding.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In order to be eligible to receive a grant, an applicant:</text> <paragraph num="(1)"> <text>May be a nonprofit or for-profit entity;</text> </paragraph> <paragraph num="(2)"> <text>Shall have an office located in Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>May only propose work that will serve or benefit one or more Maryland residents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Allowable Uses of the Funds."> <paragraph num="A."> <text>A grantee that is funded to conduct cancer research by the Fund may use the grant funds:</text> <paragraph num="(1)"> <text>For basic, clinical, translational, applied, or community-based participatory research;</text> </paragraph> <paragraph num="(2)"> <text>To support:</text> <paragraph num="(a)"> <text>The individuals engaged in the research; and</text> </paragraph> <paragraph num="(b)"> <text>The individual's support staff; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To purchase office supplies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A grantee that is funded to conduct cancer primary prevention or secondary prevention by the Fund may use the grant funds for:</text> <paragraph num="(1)"> <text>Education;</text> </paragraph> <paragraph num="(2)"> <text>Outreach;</text> </paragraph> <paragraph num="(3)"> <text>Policy changes;</text> </paragraph> <paragraph num="(4)"> <text>Provider interventions;</text> </paragraph> <paragraph num="(5)"> <text>Clinical services;</text> </paragraph> <paragraph num="(6)"> <text>Case management;</text> </paragraph> <paragraph num="(7)"> <text>Quality assurance;</text> </paragraph> <paragraph num="(8)"> <text>Data collection; or</text> </paragraph> <paragraph num="(9)"> <text>Partnership development.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a grantee is funded to conduct cancer secondary prevention services, the Fund shall provide to the grantee reimbursement for a clinical service at a rate not higher than the rate that:</text> <paragraph num="(1)"> <text>Medicare pays for the clinical service in the region; or</text> </paragraph> <paragraph num="(2)"> <text>The HSCRC has approved for the clinical service, if the clinical service is provided by a HSCRC-regulated facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a grantee is funded to conduct cancer secondary prevention or treatment, the grantee shall only provide clinical services to individuals who:</text> <paragraph num="(1)"> <text>Are Maryland residents; and</text> </paragraph> <paragraph num="(2)"> <text>Have an annual family income that is not more than 250 percent of the federal poverty guidelines.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a grantee is funded to conduct cancer treatment, a grantee may use the grant funds:</text> <paragraph num="(1)"> <text>For grants awarded before January 1, 2014 to provide MHIP reimbursement, to pay up to a maximum of $15,000 for direct costs per individual per year for the premium, deductible, coinsurance, and copay of the MHIP costs and for services not covered under MHIP; or</text> </paragraph> <paragraph num="(2)"> <text>To pay up to a specified amount, as determined by the Department, for direct costs per individual per year for the:</text> <paragraph num="(a)"> <text>Deductible and patient contribution amount for the reimbursed medical procedure or service for insured individuals; and</text> </paragraph> <paragraph num="(b)"> <text>Medical procedure or service not covered under their health insurance policy for individuals who meet the eligibility criteria of §D of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To pay up to a maximum of $20,000 for direct costs per individual per year for the cancer treatment costs under the individual’s treatment plan:</text> <paragraph num="(a)"> <text>Who meet the eligibility criteria in §D of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>At a rate not to exceed the rate that Medical Assistance pays for clinical services or the rate that the HSCRC has approved for the clinical services, if treatment is provided by a HSCRC-regulated facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>If a grantee is funded to pay for cancer treatment:</text> <paragraph num="(1)"> <text>Under §E(1) of this regulation, the grantee shall only pay or direct the Department to pay MHIP the following for services directly related to the treatment of cancer for the individual diagnosed with cancer:</text> <paragraph num="(a)"> <text>Premiums;</text> </paragraph> <paragraph num="(b)"> <text>Deductibles;</text> </paragraph> <paragraph num="(c)"> <text>Coinsurance; and</text> </paragraph> <paragraph num="(d)"> <text>Copays;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Under §E(2) of this regulation, the grantee shall only pay or direct the Department to pay the deductible and patient contribution amount for the reimbursed medical procedure or service that the individual is required to pay for the services directly related to the diagnosis and treatment of cancer; and</text> </paragraph> <paragraph num="(3)"> <text>May not pay any amount for the individual’s spouse, children, or other family members’ health insurance costs.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For the purpose of §F(1) and (2) of this regulation, the Department shall pay the health insurance costs out of the funds that are set aside for the grantee.</text> </paragraph> <paragraph num="H."> <text>In addition to the direct costs allowed under §E of this regulation, the Fund shall also pay a maximum of 7 percent of the indirect costs to local health department grantees or non-local health department grantees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Unallowable Uses of Grant Funds."> <text>A grantee may not use grant funds from the Fund to pay for:</text> <paragraph num="A."> <text>Major medical equipment purchases;</text> </paragraph> <paragraph num="B."> <text>Renovations;</text> </paragraph> <paragraph num="C."> <text>Capital expenditures; or</text> </paragraph> <paragraph num="D."> <text>Cancer prevention or cancer treatment that would be provided by an individual's existing health insurance, including:</text> <paragraph num="(1)"> <text>Medical Assistance;</text> </paragraph> <paragraph num="(2)"> <text>Medicare; or</text> </paragraph> <paragraph num="(3)"> <text>Private health insurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Grant Application."> <paragraph num="A."> <text>A person may obtain an application packet from the CCPC for a cancer:</text> <paragraph num="(1)"> <text>Research grant;</text> </paragraph> <paragraph num="(2)"> <text>Primary prevention grant;</text> </paragraph> <paragraph num="(3)"> <text>Secondary prevention grant; or</text> </paragraph> <paragraph num="(4)"> <text>Treatment grant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant may:</text> <paragraph num="(1)"> <text>Apply for one or more grants in any fiscal year; and</text> </paragraph> <paragraph num="(2)"> <text>Combine multiple requests for cancer research, primary prevention, or secondary prevention grants within a single application, provided that the information required for separate grant applications is included in the combined application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Application Process for Cancer Research Grants."> <text>An applicant for a cancer research grant shall:</text> <paragraph num="A."> <text>Submit a completed application to the CCPC by the due date listed in the application packet; and</text> </paragraph> <paragraph num="B."> <text>Include in the application packet the following information as specified in the Department’s application packet:</text> <paragraph num="(1)"> <text>An executive summary stating:</text> <paragraph num="(a)"> <text>How the grant funds will be used;</text> </paragraph> <paragraph num="(b)"> <text>What institutions and other persons will be involved in the research;</text> </paragraph> <paragraph num="(c)"> <text>Whether basic, clinical, applied, translational, or community-based research is being proposed;</text> </paragraph> <paragraph num="(d)"> <text>Whether the proposed research is included in a recommendation of the Maryland Comprehensive Cancer Control Plan; and</text> </paragraph> <paragraph num="(e)"> <text>How the grant money is expected to further the knowledge of cancer;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A statement of the need for the cancer research, including:</text> <paragraph num="(a)"> <text>Previous literature in the area; and</text> </paragraph> <paragraph num="(b)"> <text>Any work that the applicant has done in the research area;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A proposed cancer research plan describing:</text> <paragraph num="(a)"> <text>How the grant funds will be used;</text> </paragraph> <paragraph num="(b)"> <text>Who will be involved in the research;</text> </paragraph> <paragraph num="(c)"> <text>What the anticipated results of the research with the grant funds will be; and</text> </paragraph> <paragraph num="(d)"> <text>What goals, objectives, and activities will be pursued with the grant funds;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A brief professional resume or curriculum vitae of:</text> <paragraph num="(a)"> <text>The principal investigator; and</text> </paragraph> <paragraph num="(b)"> <text>Other key staff;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A description of how the proposed research will help to eliminate disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(6)"> <text>A list of the institutional review boards to which the research will be submitted for review and approval before the research is initiated, including the:</text> <paragraph num="(a)"> <text>Department's Institutional Review Board; and</text> </paragraph> <paragraph num="(b)"> <text>Applicant's relevant institutional review board;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A timeline showing the expected start date and completion date for each activity to be conducted under the grant, including application to and approval from the:</text> <paragraph num="(a)"> <text>Department's Institutional Review Board; and</text> </paragraph> <paragraph num="(b)"> <text>Applicant's relevant institutional review board;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>An organizational chart showing where the work under the research grant is located within the applicant's organization;</text> </paragraph> <paragraph num="(9)"> <text>A statement that the grant funds will not be used to supplant any existing funding for this cancer research and, if an applicant receives funding for a similar cancer research activity, a listing of the funding:</text> <paragraph num="(a)"> <text>Source;</text> </paragraph> <paragraph num="(b)"> <text>Amount; and</text> </paragraph> <paragraph num="(c)"> <text>Period for the activity;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A line item budget for the cancer research grant; and</text> </paragraph> <paragraph num="(11)"> <text>A written budget justification for each line item request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Application Process for Cancer Primary Prevention Grants."> <text>An applicant for a cancer primary prevention grant shall:</text> <paragraph num="A."> <text>Submit a completed application to the CCPC by the due date listed in the application packet; and</text> </paragraph> <paragraph num="B."> <text>Include in the application packet the following information, as specified in the Department's application packet:</text> <paragraph num="(1)"> <text>An executive summary describing:</text> <paragraph num="(a)"> <text>How the grant funds will be used;</text> </paragraph> <paragraph num="(b)"> <text>What persons will be involved in the grant activities;</text> </paragraph> <paragraph num="(c)"> <text>What cancer primary prevention activities will be conducted;</text> </paragraph> <paragraph num="(d)"> <text>Whether the primary prevention activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan;</text> </paragraph> <paragraph num="(e)"> <text>What population groups will be served and in what jurisdiction groups will be served;</text> </paragraph> <paragraph num="(f)"> <text>What types of services will be offered, including education and policy initiatives:</text> </paragraph> <paragraph num="(g)"> <text>What the eligibility for services will be; and</text> </paragraph> <paragraph num="(h)"> <text>What outcome is expected as a result of the funding;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A statement of the need for the cancer primary prevention intervention;</text> </paragraph> <paragraph num="(3)"> <text>A description of previous literature in the area documenting the effectiveness of the cancer primary prevention intervention;</text> </paragraph> <paragraph num="(4)"> <text>A proposed cancer primary prevention plan describing the:</text> <paragraph num="(a)"> <text>Estimated number of persons to be served;</text> </paragraph> <paragraph num="(b)"> <text>Goals, objectives, and activities to be conducted with the grant funds;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation measures for each activity;</text> </paragraph> <paragraph num="(d)"> <text>How the grant funds will be used;</text> </paragraph> <paragraph num="(e)"> <text>Who will be involved in the plan; and</text> </paragraph> <paragraph num="(f)"> <text>What the expected results of the activity with the grant funds are;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A description of how the primary prevention plan will address the goal of eliminating disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(6)"> <text>A list of key staff to be involved in the project, including:</text> <paragraph num="(a)"> <text>If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer primary prevention activities; or</text> </paragraph> <paragraph num="(b)"> <text>If new staff will be hired for the grant, a job description of the staff that will be responsible for carrying out the project;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A description of the previous experience of the applicant's organization in implementing similar cancer primary prevention activities;</text> </paragraph> <paragraph num="(8)"> <text>A timeline showing the expected start date and completion date for each activity to be conducted under the grant;</text> </paragraph> <paragraph num="(9)"> <text>An organizational chart showing:</text> <paragraph num="(a)"> <text>Where the activities under the cancer primary prevention grant falls within the applicant's organizational structure; and</text> </paragraph> <paragraph num="(b)"> <text>The relationship of the applicant with other organizations involved in the project;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A statement that the grant funds will not be used to supplant any existing funding for this cancer primary prevention activity and, if an applicant receives funding for a similar cancer primary prevention activity a list of the funding:</text> <paragraph num="(a)"> <text>Source;</text> </paragraph> <paragraph num="(b)"> <text>Amount; and</text> </paragraph> <paragraph num="(c)"> <text>Period for the activity;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>A line item budget for the cancer primary prevention grant; and</text> </paragraph> <paragraph num="(12)"> <text>A written budget justification for each line item requested.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Application Process for Cancer Secondary Prevention Grants."> <text>An applicant for a cancer secondary prevention grant shall:</text> <paragraph num="A."> <text>Submit a completed application to the CCPC by the due date stated in the application packet; and</text> </paragraph> <paragraph num="B."> <text>Include in the application packet the following information, as specified in the Department's application packet:</text> <paragraph num="(1)"> <text>An executive summary describing:</text> <paragraph num="(a)"> <text>How the grant funds will be used;</text> </paragraph> <paragraph num="(b)"> <text>What persons will be involved in the application;</text> </paragraph> <paragraph num="(c)"> <text>What cancer secondary prevention activities will be conducted;</text> </paragraph> <paragraph num="(d)"> <text>Whether the proposed activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan;</text> </paragraph> <paragraph num="(e)"> <text>What population groups will be served and in what jurisdiction groups will be served;</text> </paragraph> <paragraph num="(f)"> <text>What services will be offered, such as:</text> <paragraph num="(i)"> <text>Outreach;</text> </paragraph> <paragraph num="(ii)"> <text>Screening;</text> </paragraph> <paragraph num="(iii)"> <text>Case management;</text> </paragraph> <paragraph num="(iv)"> <text>Quality assurance;</text> </paragraph> <paragraph num="(v)"> <text>Data collection; and</text> </paragraph> <paragraph num="(vi)"> <text>Partnership building;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>What the eligibility for services will be; and</text> </paragraph> <paragraph num="(h)"> <text>What outcome is expected as a result of the grant funds;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A description of previous literature in the area documenting the effectiveness of the cancer secondary prevention activity;</text> </paragraph> <paragraph num="(3)"> <text>A description and justification of the need for the cancer secondary prevention activity in the population group to be served;</text> </paragraph> <paragraph num="(4)"> <text>A description of the population to be served including, at a minimum, a description of the following for the individuals to be served:</text> <paragraph num="(a)"> <text>Age;</text> </paragraph> <paragraph num="(b)"> <text>Race;</text> </paragraph> <paragraph num="(c)"> <text>Gender;</text> </paragraph> <paragraph num="(d)"> <text>Residency;</text> </paragraph> <paragraph num="(e)"> <text>Educational level;</text> </paragraph> <paragraph num="(f)"> <text>Income level; and</text> </paragraph> <paragraph num="(g)"> <text>Health insurance requirements of persons to be served;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A description of the screening guidelines to be used for clinical services and the eligibility guidelines for these services, including age, symptoms, and, if appropriate, risk factors;</text> </paragraph> <paragraph num="(6)"> <text>A description of the reimbursement levels to be used for clinical services provided with grant funds;</text> </paragraph> <paragraph num="(7)"> <text>A proposed cancer secondary prevention plan describing:</text> <paragraph num="(a)"> <text>The estimated number of individuals to be served;</text> </paragraph> <paragraph num="(b)"> <text>The goals, objectives, and activities to be conducted with the grant funds;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation measures for each activity;</text> </paragraph> <paragraph num="(d)"> <text>Who will be involved in the plan; and</text> </paragraph> <paragraph num="(e)"> <text>What the expected results of the funded activity are;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A description of how the proposed cancer secondary prevention activities will address the goal of eliminating disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(9)"> <text>A list of key staff to be involved in the project, including:</text> <paragraph num="(a)"> <text>If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer secondary prevention activities; or</text> </paragraph> <paragraph num="(b)"> <text>If new staff will be hired for this activity, a job description of the staff responsible for carrying out the project;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A description of the previous experience of the applicant's organization in implementing similar cancer secondary prevention activities;</text> </paragraph> <paragraph num="(11)"> <text>A timeline showing the expected start date and completion date for each activity to be conducted with the grant funds;</text> </paragraph> <paragraph num="(12)"> <text>An organizational chart showing:</text> <paragraph num="(a)"> <text>Where the cancer secondary prevention grant activities fall within the applicant's organizational structure; and</text> </paragraph> <paragraph num="(b)"> <text>The relationship of the applicant with other organizations involved in the project;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>A statement that the grant funds will not be used to supplant any existing funding for this cancer secondary prevention activity and, if an applicant receives funding for a similar cancer secondary prevention activity, a list of the funding:</text> <paragraph num="(a)"> <text>Source;</text> </paragraph> <paragraph num="(b)"> <text>Amount; and</text> </paragraph> <paragraph num="(c)"> <text>Period for the activity;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>A line item budget for the cancer secondary prevention grant; and</text> </paragraph> <paragraph num="(15)"> <text>A written budget justification for each line item requested.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Application Process for Cancer Treatment Grants."> <paragraph num="A."> <text>An applicant for a cancer treatment grant shall submit a completed application to the CCPC.</text> </paragraph> <paragraph num="B."> <text>Cancer treatment grants are open and continuous throughout the year to the extent that funding is available.</text> </paragraph> <paragraph num="C."> <text>An applicant seeking a cancer treatment grant to pay for cancer treatment costs shall include in the Department's application packet:</text> <paragraph num="(1)"> <text>A completed cancer treatment grant application for each individual for whom grant funds are being requested, including the:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Phone number;</text> </paragraph> <paragraph num="(c)"> <text>Mailing address;</text> </paragraph> <paragraph num="(d)"> <text>County; and</text> </paragraph> <paragraph num="(e)"> <text>Signature of the:</text> <paragraph num="(i)"> <text>Individual diagnosed with cancer if the individual is an adult; or</text> </paragraph> <paragraph num="(ii)"> <text>Parent or guardian if the individual diagnosed with cancer is younger than 18 years old;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A letter written by the individual’s physician on the physician’s letterhead:</text> <paragraph num="(a)"> <text>Confirming:</text> <paragraph num="(i)"> <text>That the individual has been diagnosed with or treated for cancer or the individual has a finding suggestive of cancer and needs to obtain a cancer diagnosis; and</text> </paragraph> <paragraph num="(ii)"> <text>The dates of diagnosis or treatment; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Containing the physician's:</text> <paragraph num="(i)"> <text>Full name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Specialty; and</text> </paragraph> <paragraph num="(iv)"> <text>Medical license number;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Proof of current Maryland residency for at least 6 months before the application date for each individual for whom grant funds are being requested in one of the following forms:</text> <paragraph num="(a)"> <text>Maryland driver’s license or State identification card;</text> </paragraph> <paragraph num="(b)"> <text>Lease or rental agreement;</text> </paragraph> <paragraph num="(c)"> <text>Property tax bill;</text> </paragraph> <paragraph num="(d)"> <text>Motor vehicle registration;</text> </paragraph> <paragraph num="(e)"> <text>Pay check or stub with name and home address;</text> </paragraph> <paragraph num="(f)"> <text>Utility bill;</text> </paragraph> <paragraph num="(g)"> <text>Voter registration card; or</text> </paragraph> <paragraph num="(h)"> <text>W-2 statement issued not more than 12 months ago;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Proof of annual family income for each individual for whom grant funds are being requested, including a copy of at least one of the following:</text> <paragraph num="(a)"> <text>Most recent:</text> <paragraph num="(i)"> <text>Income tax return; or</text> </paragraph> <paragraph num="(ii)"> <text>W-2 form;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Pay stubs for two:</text> <paragraph num="(i)"> <text>Consecutive pays; or</text> </paragraph> <paragraph num="(ii)"> <text>Pays in the same month;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Social security entitlement letter; or</text> </paragraph> <paragraph num="(d)"> <text>Notarized letter from the individual stating that the individual is not working and does not have any income;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation of the eligibility of the individual for grant funds, including:</text> <paragraph num="(a)"> <text>The family size of the individual for whom the applicant is applying; and</text> </paragraph> <paragraph num="(b)"> <text>The family’s annual household income;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Certification that the applicant will:</text> <paragraph num="(a)"> <text>Keep financial records, as described in Regulation .16B of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Send demographic and fiscal information on each individual covered to the CCPC at the end of the grant period; and</text> </paragraph> <paragraph num="(c)"> <text>Act as the authorized representative of the individual.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Attestation that grant funds will not be used to supplant any existing funding for this cancer treatment activity; and</text> </paragraph> <paragraph num="(8)"> <text>If the applicant currently receives funding for a similar cancer treatment activity, a list of the funding:</text> <paragraph num="(a)"> <text>Source;</text> </paragraph> <paragraph num="(b)"> <text>Amount; and</text> </paragraph> <paragraph num="(c)"> <text>Period for the activity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant seeking a cancer treatment grant to pay for deductibles and patient contribution costs through their health insurance policy under Regulation .08E(2) of this chapter shall include in the Department’s application packet:</text> <paragraph num="(1)"> <text>A completed and signed Maryland Cancer Fund — Cancer Treatment Grant application that;</text> <paragraph num="(a)"> <text>Certifies that the applicant shall pay:</text> <paragraph num="(i)"> <text>The deductible and patient contribution amount; and</text> </paragraph> <paragraph num="(ii)"> <text>Costs for services not covered under the individual’s health insurance policy for a time period not to exceed 1 year; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Includes a treatment plan for a total request not to exceed a specified amount, as determined by the Department, per individual per year, including the:</text> <paragraph num="(i)"> <text>Deductible and patient contribution amount; and</text> </paragraph> <paragraph num="(ii)"> <text>Costs for services not covered under the individual’s health insurance policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation of the individual’s health insurance policy.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An applicant seeking a cancer treatment grant to pay directly for cancer treatment costs under Regulation .08E(3) of this chapter shall include in the Department’s application packet:</text> <paragraph num="(1)"> <text>A completed Maryland Cancer Fund — Cancer Treatment Grant application; and</text> </paragraph> <paragraph num="(2)"> <text>A signed document that certifies that the applicant shall pay directly for cancer treatment costs for the individual for a time period not to exceed 1 year; and certifies that the applicant shall:</text> <paragraph num="(a)"> <text>Reimburse the provider in an amount not greater than the Medical Assistance rate for the medical procedure or the HSCRC-regulated rate for the medical procedure performed, if the medical procedure is performed in a HSCRC-regulated facility; or</text> </paragraph> <paragraph num="(b)"> <text>Accept the Medical Assistance rate as payment in full for the cancer treatment procedures performed, if the applicant is a medical provider; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Includes a treatment plan for a total request not to exceed $20,000 per individual, including:</text> <paragraph num="(a)"> <text>The planned cancer treatment procedures; and</text> </paragraph> <paragraph num="(b)"> <text>The Medical Assistance or HSCRC-regulated rate for each procedure.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Grant Application Review and Approval and Grant Extensions."> <paragraph num="A."> <text>Each fiscal year the CCPC shall determine:</text> <paragraph num="(1)"> <text>The amount of money available for grants under the Maryland Cancer Fund;</text> </paragraph> <paragraph num="(2)"> <text>The allocation of funding for cancer:</text> <paragraph num="(i)"> <text>Research;</text> </paragraph> <paragraph num="(ii)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(iii)"> <text>Secondary prevention; and</text> </paragraph> <paragraph num="(iv)"> <text>Treatment; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The maximum grant award amount for each type of grant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each year the Department shall consider for award, funding for one or more of the following types of grant applications for cancer:</text> <paragraph num="(1)"> <text>Research;</text> </paragraph> <paragraph num="(2)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(3)"> <text>Secondary prevention; and</text> </paragraph> <paragraph num="(4)"> <text>Treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The CCPC shall develop one or more evaluation committees or shall contract with one or more external consultants with expertise in cancer research and prevention to review the cancer research and primary prevention and secondary prevention grant applications that are submitted for funding under the Maryland Cancer Fund.</text> </paragraph> <paragraph num="D."> <text>Due to the need for timeliness in the cancer treatment grants, the CCPC shall review each application for cancer treatment.</text> </paragraph> <paragraph num="E."> <text>The evaluation committee or external consultants shall review:</text> <paragraph num="(1)"> <text>Cancer research grant applications based on:</text> <paragraph num="(a)"> <text>Scientific need;</text> </paragraph> <paragraph num="(b)"> <text>The degree to which the cancer research plan will achieve the goals and objectives set forth in the plan;</text> </paragraph> <paragraph num="(c)"> <text>The inclusion of a plan for Institutional Review Board approval;</text> </paragraph> <paragraph num="(d)"> <text>The feasibility of the timeline in delivering goals and objectives of the plan;</text> </paragraph> <paragraph num="(e)"> <text>The experience and expertise of the principal investigator;</text> </paragraph> <paragraph num="(f)"> <text>The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(g)"> <text>Whether the research is recommended in the Maryland Comprehensive Cancer Plan;</text> </paragraph> <paragraph num="(h)"> <text>The lack of other resources or funding for the proposed research; and</text> </paragraph> <paragraph num="(i)"> <text>The amount of the funding requested;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cancer primary prevention grant applications based on:</text> <paragraph num="(a)"> <text>The need for the cancer primary prevention activity;</text> </paragraph> <paragraph num="(b)"> <text>The previously documented effectiveness of the primary prevention intervention;</text> </paragraph> <paragraph num="(c)"> <text>The degree to which the cancer primary prevention plan will achieve the goals and objectives set forth in the plan;</text> </paragraph> <paragraph num="(d)"> <text>The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(e)"> <text>The experience of the applicant in cancer primary prevention;</text> </paragraph> <paragraph num="(f)"> <text>Whether the primary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan;</text> </paragraph> <paragraph num="(g)"> <text>The lack of other resources or funding for the proposal; and</text> </paragraph> <paragraph num="(h)"> <text>The amount of funding requested; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Cancer secondary prevention grant applications based on:</text> <paragraph num="(a)"> <text>The previously documented effectiveness of the secondary prevention intervention;</text> </paragraph> <paragraph num="(b)"> <text>The need for the cancer secondary prevention intervention in the population group to be served;</text> </paragraph> <paragraph num="(c)"> <text>The degree to which the cancer secondary prevention plan will achieve the goals and objectives of the plan;</text> </paragraph> <paragraph num="(d)"> <text>The feasibility of the timeline in delivering the goals and objectives of the plan;</text> </paragraph> <paragraph num="(e)"> <text>The extent to which medical guidelines for screening and diagnosis are being followed;</text> </paragraph> <paragraph num="(f)"> <text>The percent of the budget allocated to clinical services;</text> </paragraph> <paragraph num="(g)"> <text>The degree to which the grant application addresses eliminating disparities between racial and ethnic minorities and the white population;</text> </paragraph> <paragraph num="(h)"> <text>The experience of the applicant in cancer secondary prevention;</text> </paragraph> <paragraph num="(i)"> <text>Whether the secondary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan;</text> </paragraph> <paragraph num="(j)"> <text>The lack of other resources or funding for the proposal; and</text> </paragraph> <paragraph num="(k)"> <text>The amount requested.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>After reviewing each cancer research, primary prevention, and secondary prevention grant application, the evaluation committee or external consultant shall make a recommendation to the CCPC about whether to award grant funds to each applicant.</text> </paragraph> <paragraph num="G."> <text>The CCPC shall review each cancer treatment application based on:</text> <paragraph num="(1)"> <text>Completeness;</text> </paragraph> <paragraph num="(2)"> <text>Availability of funds; and</text> </paragraph> <paragraph num="(3)"> <text>Whether the application meets the relevant application process requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Director of the CCPC shall recommend an application to the Secretary for approval based upon:</text> <paragraph num="(1)"> <text>The evaluation committee's or external consultant's recommendations for awarding the cancer research, primary prevention, secondary prevention, and treatment grants for each application; and</text> </paragraph> <paragraph num="(2)"> <text>The availability of funds.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Secretary shall:</text> <paragraph num="(1)"> <text>Consider the grant recommendations of the CCPC for the cancer:</text> <paragraph num="(a)"> <text>Research;</text> </paragraph> <paragraph num="(b)"> <text>Primary prevention;</text> </paragraph> <paragraph num="(c)"> <text>Secondary prevention; and</text> </paragraph> <paragraph num="(d)"> <text>Treatment; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Make the final determination on which grant applications to approve.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A grant period expires 1 year from the date of award of the grant, unless extended as set forth in Regulation .16 of this chapter.</text> </paragraph> <paragraph num="K."> <text>A person awarded a grant under this chapter may apply for a no-cost extension of the grant period for the award before the expiration of the grant period, as set forth in §J of this regulation, by submitting a written request for an extension to the CCPC.</text> </paragraph> <paragraph num="L."> <text>In evaluating whether to grant an extension of the grant period, the CCPC:</text> <paragraph num="(1)"> <text>Shall assess whether progress has been made on the grant; and</text> </paragraph> <paragraph num="(2)"> <text>If progress has been made based on the reports submitted pursuant to Regulation .16C of this chapter, may recommend to the Secretary that an extension be granted.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The Secretary may approve an extension for up to 1 year based on:</text> <paragraph num="(1)"> <text>The recommendation of the CCPC; and</text> </paragraph> <paragraph num="(2)"> <text>Whether progress has been shown on the grant pursuant to Regulation .16C of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Payments, Terms and Conditions of Grant Awards, and Terminations."> <paragraph num="A."> <text>Payments Under the Grant.</text> <paragraph num="(1)"> <text>The Department may not make more than monthly payments during the grant period to a person awarded a grant under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Before the first payment under the grant, at the request of the person awarded the grant under this chapter, the Department may approve an advanced payment for the grant based on financial need, if a request for advanced payment was specified in the grant application.</text> </paragraph> <paragraph num="(3)"> <text>If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Financial Reports and Records.</text> <paragraph num="(1)"> <text>A person awarded a grant shall:</text> <paragraph num="(a)"> <text>Establish a separate account to track expenditures under the grant;</text> </paragraph> <paragraph num="(b)"> <text>Maintain accurate records, including documentation of each transaction pertaining to the grant; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to the Department monthly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may audit the accounts referenced in §B(1) of this regulation at any time.</text> </paragraph> <paragraph num="(3)"> <text>A person awarded a grant under this chapter shall submit to the Department within 90 days after the date the grant period ends:</text> <paragraph num="(a)"> <text>A final financial expenditure report; and</text> </paragraph> <paragraph num="(b)"> <text>A refund of any unexpended funds.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A person awarded a grant under this chapter shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Progress Reports.</text> <paragraph num="(1)"> <text>A grantee shall submit to the CCPC three copies of:</text> <paragraph num="(a)"> <text>An interim report describing the progress of the grant:</text> <paragraph num="(i)"> <text>6 months after the date of award of the grant; and</text> </paragraph> <paragraph num="(ii)"> <text>Every 6 months until the end of the grant; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A comprehensive final report, not later than 60 days after the date the grant period ends, that provides a summary of all of the activity conducted under the grant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A grantee receiving a cancer research grant shall include the following information in the comprehensive final report:</text> <paragraph num="(a)"> <text>Hypothesis;</text> </paragraph> <paragraph num="(b)"> <text>Methods;</text> </paragraph> <paragraph num="(c)"> <text>Results;</text> </paragraph> <paragraph num="(d)"> <text>Discussion of results and limitations of the research; and</text> </paragraph> <paragraph num="(e)"> <text>Conclusion.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A grantee receiving a cancer primary prevention or secondary prevention grant shall include the following information in the comprehensive final report:</text> <paragraph num="(a)"> <text>Number of individuals served, by:</text> <paragraph num="(i)"> <text>Type of service;</text> </paragraph> <paragraph num="(ii)"> <text>Age;</text> </paragraph> <paragraph num="(iii)"> <text>Race; and</text> </paragraph> <paragraph num="(iv)"> <text>Gender;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Number of individuals with abnormal screening results, by type of cancer;</text> </paragraph> <paragraph num="(c)"> <text>Number of cancers diagnosed; and</text> </paragraph> <paragraph num="(d)"> <text>Other outcome measures.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A grantee receiving a cancer treatment grant shall include the following information in the comprehensive final report for each individual receiving funds for cancer treatment:</text> <paragraph num="(a)"> <text>Type of cancer;</text> </paragraph> <paragraph num="(b)"> <text>Stage of cancer at diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Age;</text> </paragraph> <paragraph num="(d)"> <text>Race;</text> </paragraph> <paragraph num="(e)"> <text>Gender;</text> </paragraph> <paragraph num="(f)"> <text>County; and</text> </paragraph> <paragraph num="(g)"> <text>Amount of funds expended.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Publications.</text> <paragraph num="(1)"> <text>A person who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Maryland Cancer Fund of the Maryland Department of Health.”</text> </paragraph> <paragraph num="(2)"> <text>A person awarded a grant under this chapter shall provide the Department with three copies of any published article pertaining to the activities conducted under the grant.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Ownership of Equipment. A person awarded a grant under this chapter:</text> <paragraph num="(1)"> <text>Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant;</text> </paragraph> <paragraph num="(2)"> <text>Shall keep an inventory of all equipment purchased; and</text> </paragraph> <paragraph num="(3)"> <text>May not transfer the equipment to another entity without the written permission of the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Termination.</text> <paragraph num="(1)"> <text>The Secretary may terminate a grant:</text> <paragraph num="(a)"> <text>If a grantee fails to comply with:</text> <paragraph num="(i)"> <text>The requirements of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>State, federal, and municipal laws applicable to the performance of research under the grant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If a grantee fails to carry out the purposes for which the grant was awarded;</text> </paragraph> <paragraph num="(c)"> <text>In compliance with a court order; or</text> </paragraph> <paragraph num="(d)"> <text>At the request of the grantee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant.</text> </paragraph> <paragraph num="(3)"> <text>The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Compliance with Existing Laws. A person awarded a grant under this chapter shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws.</text> </paragraph> <paragraph num="H."> <text>Liability.</text> <paragraph num="(1)"> <text>A person awarded a grant under this chapter is solely responsible for the person's actions pertaining to research conducted under a grant award.</text> </paragraph> <paragraph num="(2)"> <text>The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from research conducted under a grant awarded under this chapter.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Grant Agreements. A person awarded a grant under this chapter shall enter into a grant agreement with the Department.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-117; Tax-General Article, §2-112; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 adopted as an emergency provision effective June 1, 2006 (33:15 Md. R. 1274); adopted permanently effective October 9, 2006 (33:20 Md. R. 1616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); amended permanently effective April 6, 2009 (36:7 Md. R. 524)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 4, 2010 (37:20 Md. R. 1393); March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D, E amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C, D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16C amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16C amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16D amended effective October 4, 2010 (37:20 Md. R. 1393)</annotation> </annotations> </chapter> <chapter num="06" heading="Cigarette Restitution Fund Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the financial eligibility criteria for an uninsured or underinsured individual to receive cancer treatment services and tobacco treatment products under the Cigarette Restitution Fund Program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has applied to receive cancer treatment services or tobacco treatment products under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Cancer Prevention, Education, Screening, and Treatment Program” means the program created by Health-General Article, §§13-1101—13-1119, Annotated Code of Maryland, to provide cancer prevention, education, screening, and treatment services in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Cancer treatment service” means a medical service, medical supply, or medical equipment provided to:</text> <paragraph num="(a)"> <text>Treat cancer, including:</text> <paragraph num="(i)"> <text>Surgery;</text> </paragraph> <paragraph num="(ii)"> <text>Chemotherapy;</text> </paragraph> <paragraph num="(iii)"> <text>Radiation therapy;</text> </paragraph> <paragraph num="(iv)"> <text>Hormonal therapy;</text> </paragraph> <paragraph num="(v)"> <text>Home health services; and</text> </paragraph> <paragraph num="(vi)"> <text>Medical supplies and medical equipment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Treat medical complications resulting from cancer screening or treatment;</text> </paragraph> <paragraph num="(c)"> <text>Treat other comorbid conditions in order to treat cancer; and</text> </paragraph> <paragraph num="(d)"> <text>Serve the needs of cancer patients for palliative or end-of-life care.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Federal poverty level” means the amount of household income by family size that a family needs for basic necessities as determined by the federal poverty guidelines, as amended, which are updated annually in the Federal Register by the U.S. Department of Health and Human Services.</text> </paragraph> <paragraph num="(6)"> <text>“Gross annual household income” means the total income of the applicant and any member of the applicant’s household received each year from all sources before taxes are withheld or deductions are taken.</text> </paragraph> <paragraph num="(7)"> <text>“Local health department” means a governmental entity in a county in Maryland that provides public health services.</text> </paragraph> <paragraph num="(8)"> <text>“Maryland Children’s Health Insurance Program” means the program administered by Medical Assistance to provide health insurance coverage to eligible children younger than 19 years old in Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Medical Assistance” means the program that:</text> <paragraph num="(a)"> <text>Provides comprehensive medical and other health-related care for eligible individuals; and</text> </paragraph> <paragraph num="(b)"> <text>Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396—1396v.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(11)"> <text>“Statewide academic health center” means:</text> <paragraph num="(a)"> <text>The University of Maryland Medical Group;</text> </paragraph> <paragraph num="(b)"> <text>The Johns Hopkins Institutions;</text> </paragraph> <paragraph num="(c)"> <text>The organization designated by the Department as stipulated by Health-General Article, §13-1115, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>One or more of the organizations in §B(11)(a)—(c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Tobacco product” means cigarettes, cigars, pipe tobacco, smokeless tobacco, and any other product containing tobacco in any form.</text> </paragraph> <paragraph num="(13)"> <text>“Tobacco treatment product” means all Food and Drug Administration-approved tobacco cessation medications, including both prescription and over-the-counter medications, that assist individuals to stop using tobacco products.</text> </paragraph> <paragraph num="(14)"> <text>“Tobacco Use Prevention and Cessation Program” means the program created by Health-General Article, §§13-1001—13-1014, Annotated Code of Maryland, to provide tobacco use prevention and cessation services in Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Underinsured” individual means an applicant:</text> <paragraph num="(a)"> <text>Who has private medical insurance, Medical Assistance, Medicare, or Maryland Children’s Health Insurance Program coverage;</text> </paragraph> <paragraph num="(b)"> <text>For whom the appropriate treatment is not adequately covered due to out-of-pocket costs including:</text> <paragraph num="(i)"> <text>Copayments;</text> </paragraph> <paragraph num="(ii)"> <text>Coinsurance; or</text> </paragraph> <paragraph num="(iii)"> <text>Deductibles; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Who the Department determines does not have the financial means to pay for appropriate treatment.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Uninsured” individual means an applicant who:</text> <paragraph num="(a)"> <text>Either:</text> <paragraph num="(i)"> <text>Does not have private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage; or</text> </paragraph> <paragraph num="(ii)"> <text>Has private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage that does not provide insurance coverage for medically necessary services for a cancer treatment service or tobacco treatment product; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Does not have the financial means to pay for a cancer treatment service or tobacco treatment product as defined by the criteria established in this chapter.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“University of Maryland Medical Group (UMMG)” means the University of Maryland Medical Systems Corporation, the University of Maryland Medical School, and the University of Maryland, Baltimore.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibilities of the Department."> <text>The Department shall:</text> <paragraph num="A."> <text>Establish guidelines for defining financial eligibility of an:</text> <paragraph num="(1)"> <text>Uninsured or underinsured individual for the purpose of receiving cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program; and</text> </paragraph> <paragraph num="(2)"> <text>Uninsured individual for the purpose of receiving tobacco treatment products under the Tobacco Use Prevention and Cessation Program; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Review the written documentation submitted by a local health department or Statewide academic health center to assure that the criteria listed in Regulations .05 and .06 of this chapter are followed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibilities of Local Health Departments and Statewide Academic Health Centers."> <paragraph num="A."> <text>If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will not be used to pay for cancer treatment services or tobacco treatment products:</text> <paragraph num="(1)"> <text>This chapter does not apply; and</text> </paragraph> <paragraph num="(2)"> <text>A local health department or a Statewide academic health center has no further responsibilities with respect to this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will be used to pay for cancer treatment services or tobacco treatment products:</text> <paragraph num="(1)"> <text>This chapter applies; and</text> </paragraph> <paragraph num="(2)"> <text>A local health department or a Statewide academic health center shall adhere to the financial guidelines established by the Department for:</text> <paragraph num="(a)"> <text>Cancer treatment services as set forth in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Tobacco treatment products as set forth in Regulation .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Criteria for Eligibility for Cancer Treatment Services."> <paragraph num="A."> <text>A local health department or a Statewide academic health center shall use the following financial eligibility criteria for cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program:</text> <paragraph num="(1)"> <text>The basis for determining financial eligibility shall be the gross annual household income;</text> </paragraph> <paragraph num="(2)"> <text>An applicant with a gross annual household income above 250 percent of the federal poverty level is not eligible to receive cancer treatment services;</text> </paragraph> <paragraph num="(3)"> <text>Written documentation required for determination of the gross annual household income shall include:</text> <paragraph num="(a)"> <text>The household’s most recent federal income tax return; or</text> </paragraph> <paragraph num="(b)"> <text>If a household income tax return was not filed, the following:</text> <paragraph num="(i)"> <text>The most recent W-2 statement;</text> </paragraph> <paragraph num="(ii)"> <text>Pay stubs from two consecutive pays;</text> </paragraph> <paragraph num="(iii)"> <text>A Social Security entitlement letter; or</text> </paragraph> <paragraph num="(iv)"> <text>A notarized letter from the applicant stating that the applicant is not working and does not have any income;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The household income level for determining financial eligibility shall be based on the size of the family unit including the applicant and may include the following individuals as verified by the most recent tax return:</text> <paragraph num="(a)"> <text>The applicant’s spouse;</text> </paragraph> <paragraph num="(b)"> <text>Any financially dependent children; or</text> </paragraph> <paragraph num="(c)"> <text>Any financially dependent relative; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The type of written documentation that an applicant shall provide in order to document the size of the family unit includes the following:</text> <paragraph num="(a)"> <text>The most recent income tax return;</text> </paragraph> <paragraph num="(b)"> <text>A divorce decree, if applicable; or</text> </paragraph> <paragraph num="(c)"> <text>If a household income tax return was not filed, written documentation shall include the names, ages, and relationship to the applicant of individuals supported by the gross annual household income.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A local health department or a Statewide academic health center may establish requirements for eligibility of cancer treatment services in addition to those cited in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Criteria for Eligibility for Tobacco Treatment Products."> <text>A local health department shall make tobacco treatment products available free of charge to an individual participating in the Cigarette Restitution Fund Program.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Funding Availability."> <text>Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-1001—13-1014 and 13-1101—13-1119, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 15, 2007 (34:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective February 27, 2017 (44:4 Md. R. 254)</annotation> </annotations> </chapter> <chapter num="07" heading="Cord Blood Transplant Center Support Fund"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Defines the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund;</text> </paragraph> <paragraph num="B."> <text>Describes how funds may be allocated to the Cord Blood Transplant Center Support Fund;</text> </paragraph> <paragraph num="C."> <text>Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund;</text> </paragraph> <paragraph num="D."> <text>Outlines the grant application process for the Cord Blood Transplant Center Support Fund; and</text> </paragraph> <paragraph num="E."> <text>Outlines grantee reporting requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Comptroller” means the Comptroller of the Treasury.</text> </paragraph> <paragraph num="(2)"> <text>“Cord Blood Transplant Center” means a medical facility that:</text> <paragraph num="(a)"> <text>Uses cells obtained from a human umbilical cord or placenta to treat pediatric or adult patients afflicted with a disease or injury; and</text> </paragraph> <paragraph num="(b)"> <text>Is a member of the National Marrow Donor Program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Fund” means the Cord Blood Transplant Center Support Fund.</text> </paragraph> <paragraph num="(5)"> <text>Grant.</text> <paragraph num="(a)"> <text>“Grant” means financial assistance from the State to support an applicant's activities related to cord blood transplantation.</text> </paragraph> <paragraph num="(b)"> <text>“Grant” does not mean a contract.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Program” means the Cord Blood Transplant Program.</text> </paragraph> <paragraph num="(7)"> <text>“Qualified medical institution” means a medical institution that:</text> <paragraph num="(a)"> <text>Is accredited by the Joint Commission on Accreditation of Health Care Organizations;</text> </paragraph> <paragraph num="(b)"> <text>Is located in the State;</text> </paragraph> <paragraph num="(c)"> <text>Has an established hematologic malignancies research program; and</text> </paragraph> <paragraph num="(d)"> <text>Meets all requirements established in the request for proposals issued by the Cord Blood Transplant Program.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Cord Blood Transplant Program."> <paragraph num="A."> <text>There is a Cord Blood Transplant Program in the Department.</text> </paragraph> <paragraph num="B."> <text>The purpose of the Program is to provide funding to qualified medical institutions to establish or maintain a cord blood transplant center.</text> </paragraph> <paragraph num="C."> <text>The Program administers the Fund to provide grants, subject to the limitations of the State budget, to qualified medical institutions to establish or maintain a cord blood transplant center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Cord Blood Transplant Center Support Fund."> <paragraph num="A."> <text>The purpose of the Fund is to promote economic development by supporting cord blood transplant centers at qualified medical institutions with a goal of being recognized as a regional center of excellence in the area of cord blood transplantation.</text> </paragraph> <paragraph num="B."> <text>The Fund is:</text> <paragraph num="(1)"> <text>A nonlapsing, special fund pursuant to Health-General Article, §13-3001, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Not subject to the State Finance and Procurement Article, §7-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Fund consists of any:</text> <paragraph num="(1)"> <text>Money appropriated in the State budget to the Fund; and</text> </paragraph> <paragraph num="(2)"> <text>Other money from any other source accepted for the benefit of the Fund.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may only expend funds in accordance with an appropriation approved by the General Assembly in the annual State budget.</text> </paragraph> <paragraph num="E."> <text>The Department may only make grant awards under the Fund for the establishment of or support for a cord blood transplant center at a qualified medical institution.</text> </paragraph> <paragraph num="F."> <text>Any unspent portions of the Fund shall remain in the Fund and may not revert or be credited to the general fund of the State, nor any other special fund of the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of the Department."> <text>The Department shall:</text> <paragraph num="A."> <text>Administer the Program and perform related administration activities, including:</text> <paragraph num="(1)"> <text>Develop and release an annual request for proposals;</text> </paragraph> <paragraph num="(2)"> <text>Convene an expert panel to review applications and select grantees; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that grantees remain in compliance with request for proposals requirements;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Administer the Fund;</text> </paragraph> <paragraph num="C."> <text>Provide a grant or grants in each fiscal year, in accordance with the State budget, to qualified medical institutions; and</text> </paragraph> <paragraph num="D."> <text>Maintain records of grantee activities supported by the Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Allowable Use of the Fund."> <text>A grantee may use awarded funds to establish or maintain a cord blood transplant center, which includes support of:</text> <paragraph num="A."> <text>Individuals engaged in the establishment or maintenance of a cord blood transplant center; and</text> </paragraph> <paragraph num="B."> <text>Equipment necessary for the establishment or maintenance of a cord blood transplant center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Unallowable Use of the Fund."> <text>A grantee may not use awarded funds to pay for activities not provided for in the approved grant application.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Application Process for Cord Blood Transplant Center Grants."> <text>An applicant for a cord blood transplant center grant shall:</text> <paragraph num="A."> <text>Submit a completed application to the Department by the due date listed in the annual request for proposals; and</text> </paragraph> <paragraph num="B."> <text>Include in the application packet the following information as specified in the annual request for proposals:</text> <paragraph num="(1)"> <text>Executive summary;</text> </paragraph> <paragraph num="(2)"> <text>Statement of the need for funding;</text> </paragraph> <paragraph num="(3)"> <text>Proposed work plan for the grant period;</text> </paragraph> <paragraph num="(4)"> <text>Brief professional resume or curriculum vitae of key staff involved in the grant activities;</text> </paragraph> <paragraph num="(5)"> <text>Description of how the requested funding will further the institution’s goal of being recognized as a cord blood transplantation regional center of excellence;</text> </paragraph> <paragraph num="(6)"> <text>Timeline detailing the expected start and completion dates for each activity to be conducted under the grant;</text> </paragraph> <paragraph num="(7)"> <text>Organizational chart indicating where the work under the grant will be located within the institution;</text> </paragraph> <paragraph num="(8)"> <text>Statement that the grant money will not be used to supplant any existing funding;</text> </paragraph> <paragraph num="(9)"> <text>Line item budget for the grant; and</text> </paragraph> <paragraph num="(10)"> <text>Written budget justification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Grant Application Review, Selection of Grantees, and Grant Extensions."> <paragraph num="A."> <text>The Department shall determine the amount of money available for grants under the Cord Blood Transplant Center Support Fund annually.</text> </paragraph> <paragraph num="B."> <text>Each year the Program shall consider awarding a grant to at least one qualified medical institution.</text> </paragraph> <paragraph num="C."> <text>The Program shall convene a grant evaluation committee to review the grant applications.</text> </paragraph> <paragraph num="D."> <text>Members of the evaluation committee may include one or more external individuals with expertise in cord blood transplantation.</text> </paragraph> <paragraph num="E."> <text>The evaluation committee shall review grant applications based on criteria stated in the Request for Proposals.</text> </paragraph> <paragraph num="F."> <text>The Program shall recommend a grant application to the Secretary for approval based on:</text> <paragraph num="(1)"> <text>The evaluation committee's recommendations for awarding the grants; and</text> </paragraph> <paragraph num="(2)"> <text>The availability of funds.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Secretary shall:</text> <paragraph num="(1)"> <text>Consider the grant award recommendations of the Program; and</text> </paragraph> <paragraph num="(2)"> <text>Make the final determination on which grant applications to approve.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A grant period expires 1 year from the date of award of the grant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Payments, Terms and Conditions of Grant Awards, and Terminations."> <paragraph num="A."> <text>Payments Under the Grant.</text> <paragraph num="(1)"> <text>The Department may not make more than quarterly payments during the grant period to a grantee awarded a grant under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Before the first payment under the grant, at the request of the grantee in their submitted grant application, the Department may approve an advanced payment for the grant based on financial need.</text> </paragraph> <paragraph num="(3)"> <text>If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Financial Reports and Records.</text> <paragraph num="(1)"> <text>A grantee shall:</text> <paragraph num="(a)"> <text>Establish a separate account to track expenditures under the grant;</text> </paragraph> <paragraph num="(b)"> <text>Maintain accurate records, including documentation of each transaction pertaining to the grant; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to the Department quarterly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may audit the accounts referenced in §B(1) of this regulation at any time.</text> </paragraph> <paragraph num="(3)"> <text>Within 90 days after the date the grant period ends, a grantee shall submit to the Department:</text> <paragraph num="(a)"> <text>A final financial expenditure report; and</text> </paragraph> <paragraph num="(b)"> <text>A refund of any unexpended funds.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A grantee shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Progress Reports.</text> <paragraph num="(1)"> <text>A grantee shall submit to the Program one electronic copy of:</text> <paragraph num="(a)"> <text>An interim report describing the progress of the grant:</text> <paragraph num="(i)"> <text>6 months after the date of award of the grant; and</text> </paragraph> <paragraph num="(ii)"> <text>Every 6 months until the end of the grant; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Not later than 60 days after the date the grant period ends, a comprehensive final report, that provides a summary of all of the activity conducted under the grant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Publications.</text> <paragraph num="(1)"> <text>A grantee who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Cord Blood Transplant Center Support Fund of the Maryland Department of Health.”</text> </paragraph> <paragraph num="(2)"> <text>A grantee shall provide the Department with one electronic copy of any published article pertaining to the activities conducted under the grant.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Ownership of Equipment. A grantee:</text> <paragraph num="(1)"> <text>Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant;</text> </paragraph> <paragraph num="(2)"> <text>Shall keep an inventory of all equipment purchased; and</text> </paragraph> <paragraph num="(3)"> <text>May not transfer the equipment to another entity without the written permission of the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Termination.</text> <paragraph num="(1)"> <text>The Secretary may terminate a grant:</text> <paragraph num="(a)"> <text>If a grantee fails to comply with:</text> <paragraph num="(i)"> <text>The requirements of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>State, federal, and municipal laws applicable to the performance of research under the grant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If a grantee fails to carry out the purposes for which the grant was awarded;</text> </paragraph> <paragraph num="(c)"> <text>In compliance with a court order; or</text> </paragraph> <paragraph num="(d)"> <text>At the request of the grantee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant.</text> </paragraph> <paragraph num="(3)"> <text>The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Compliance with Existing Laws. A grantee shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws.</text> </paragraph> <paragraph num="H."> <text>Liability.</text> <paragraph num="(1)"> <text>A grantee is solely responsible for the institution's actions relating to the grant-making process or pertaining to activities conducted under a grant award.</text> </paragraph> <paragraph num="(2)"> <text>The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from activities relating to the grant-making process or conducted under a grant awarded under this chapter.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Grant Agreements. A grantee shall enter into a grant agreement with the Department.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-3001 — 13-3004, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 472)</annotation> </annotations> </chapter> <chapter num="08" heading="Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter sets forth the:</text> <paragraph num="A."> <text>Responsibilities of the Maryland Department of Health for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program established by Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Responsibilities of a grantee that receives funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program;</text> </paragraph> <paragraph num="C."> <text>Application process for a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program; and</text> </paragraph> <paragraph num="D."> <text>Reporting requirements for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an entity that applies to receive a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program.</text> </paragraph> <paragraph num="(2)"> <text>Cancer Screening Test.</text> <paragraph num="(a)"> <text>“Cancer screening test” means a test that is designed to find cancer in an individual who does not present cancer signs or symptoms.</text> </paragraph> <paragraph num="(b)"> <text>“Cancer screening test” includes, but is not limited to:</text> <paragraph num="(i)"> <text>A laboratory test;</text> </paragraph> <paragraph num="(ii)"> <text>An imaging procedure;</text> </paragraph> <paragraph num="(iii)"> <text>A medical procedure; and</text> </paragraph> <paragraph num="(iv)"> <text>A genetic test.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Cost effectiveness” means a comparison between cost and expected health outcomes of a cancer test or intervention.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Grant” means funds distributed to a grantee under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program.</text> </paragraph> <paragraph num="(6)"> <text>“Grantee” means a local fire department, volunteer fire department, or volunteer fire company approved to receive funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program.</text> </paragraph> <paragraph num="(7)"> <text>“Health care provider” means a doctor of medicine or osteopathy, dentist, nurse practitioner, or physician assistant who is authorized to practice by the state in which the individual practices.</text> </paragraph> <paragraph num="(8)"> <text>“Local fire department” means a fire department operating in a Maryland county or Baltimore City.</text> </paragraph> <paragraph num="(9)"> <text>“Program” means the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program.</text> </paragraph> <paragraph num="(10)"> <text>“Qualifications” means the education, experience, skills, and licensing of an individual associated with a Program grant application.</text> </paragraph> <paragraph num="(11)"> <text>“Volunteer fire company” means a volunteer fire company operating in a Maryland county or Baltimore City.</text> </paragraph> <paragraph num="(12)"> <text>“Volunteer fire department” means a volunteer fire department operating in a Maryland county or Baltimore City.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibilities of the Department."> <text>The Department shall:</text> <paragraph num="A."> <text>Administer the Program;</text> </paragraph> <paragraph num="B."> <text>Provide one or more grants to local fire departments, volunteer fire companies, or volunteer fire departments to procure innovative cancer screening tests according to Health-General Article, §13-4003(a), Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>Develop and distribute an application for Program grants each fiscal year if funding is available;</text> </paragraph> <paragraph num="D."> <text>Maintain a record of information submitted by a grantee to the Department; and</text> </paragraph> <paragraph num="E."> <text>Monitor the activities of a grantee to ensure compliance with the requirements of the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Entities Eligible for Grants."> <text>The following entities are eligible to apply for and receive a grant from the Department under the Program:</text> <paragraph num="A."> <text>A local fire department;</text> </paragraph> <paragraph num="B."> <text>A volunteer fire company;</text> </paragraph> <paragraph num="C."> <text>A volunteer fire department; and</text> </paragraph> <paragraph num="D."> <text>If authorized by a local fire department, volunteer fire company, or volunteer fire department, a county.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Use of Grant Funds."> <paragraph num="A."> <text>A grantee may use awarded funds to:</text> <paragraph num="(1)"> <text>Procure and administer innovative cancer screening tests that are not otherwise conducted during routine physical examinations or covered by insurance to professional firefighters employed by a local fire department and volunteer firefighters who serve in a volunteer fire company or department; and</text> </paragraph> <paragraph num="(2)"> <text>Pay for activities directly associated with the grant that are approved by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A grantee may not use awarded funds to pay for an activity that is not included in the approved grant application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program Grants."> <paragraph num="A."> <text>An applicant:</text> <paragraph num="(1)"> <text>Shall submit a completed application to the Department by the due date listed in the request for applications;</text> </paragraph> <paragraph num="(2)"> <text>Shall include in the application all required information listed in the request for applications, including:</text> <paragraph num="(a)"> <text>The names and qualifications of the health care providers that will advise the applicant on the selection and administration of cancer screening tests;</text> </paragraph> <paragraph num="(b)"> <text>The number of firefighters to be screened;</text> </paragraph> <paragraph num="(c)"> <text>The selection criteria the applicant used to identify firefighters at the highest cancer risk based on the latest scientific and medical research; and</text> </paragraph> <paragraph num="(d)"> <text>A description of each test to be procured by the applicant, including:</text> <paragraph num="(i)"> <text>The claimed accuracy and reliability of the test;</text> </paragraph> <paragraph num="(ii)"> <text>The scientific and clinical evidence supporting the claimed accuracy and reliability of the test;</text> </paragraph> <paragraph num="(iii)"> <text>Whether the test employs innovative or novel technologies, such as DNA sequencing, genomics, proteomics, metabolomics, machine learning, artificial intelligence, big data analytics, or other state-of-the-art technology;</text> </paragraph> <paragraph num="(iv)"> <text>Whether the test has the ability to simultaneously screen for two or more cancer types for which firefighters have a higher incidence or death rate;</text> </paragraph> <paragraph num="(v)"> <text>The cost of the test; and</text> </paragraph> <paragraph num="(vi)"> <text>Whether the test is developed, manufactured, or commercialized by a business entity located in the State; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>May voluntarily withdraw an application at any time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The county in which a volunteer fire company or department is located shall assist a volunteer fire company or a volunteer fire department in submitting an application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Application Review, Selection of Grantees, and Grant Period."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Determine the amount of money available for grants under the Program in each fiscal year;</text> </paragraph> <paragraph num="(2)"> <text>Develop a weighting formula to rate each application received by the Program;</text> </paragraph> <paragraph num="(3)"> <text>Make available the weighting formula on the Program website and include the weighting formula in the request for applications;</text> </paragraph> <paragraph num="(4)"> <text>Request additional information or changes to the application if necessary; and</text> </paragraph> <paragraph num="(5)"> <text>Reject an application that does not meet the application requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall review and prioritize applications based on the quality of the application received and the degree to which the tests listed on the application meet the following criteria:</text> <paragraph num="(1)"> <text>The scientific and clinical evidence supporting the claimed accuracy and reliability of test;</text> </paragraph> <paragraph num="(2)"> <text>Whether the test employs innovative or novel technologies;</text> </paragraph> <paragraph num="(3)"> <text>The ability of the test to simultaneously screen for two or more cancer types;</text> </paragraph> <paragraph num="(4)"> <text>The cost effectiveness of the test; and</text> </paragraph> <paragraph num="(5)"> <text>Whether the test is developed, manufactured, or commercialized by a business entity located in the State.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may review an application in consultation with one or more experts in cancer screening.</text> </paragraph> <paragraph num="D."> <text>If the Department receives applications for grant funds totaling more than the amount of funds appropriated for the Program, the Department shall award the funds on a pro rata basis.</text> </paragraph> <paragraph num="E."> <text>Funds shall be awarded under the Program for a maximum of 1 year..</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Payments, Terms and Conditions of Grant Awards, and Terminations."> <paragraph num="A."> <text>Payments.</text> <paragraph num="(1)"> <text>The Department may approve an advance payment based on financial need.</text> </paragraph> <paragraph num="(2)"> <text>If a financial or progress report required by §B or C of this regulation is overdue, the Department may withhold payment of funds to a grantee until the financial or progress report is submitted.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Financial Reports and Records.</text> <paragraph num="(1)"> <text>A grantee shall:</text> <paragraph num="(a)"> <text>Establish a separate account to track expenditures under the grant;</text> </paragraph> <paragraph num="(b)"> <text>Maintain accurate records, including documentation of each transaction associated with the grant;</text> </paragraph> <paragraph num="(c)"> <text>Submit invoices for payment of grant funds to the Department within the deadline specified by the Department;</text> </paragraph> <paragraph num="(d)"> <text>Submit a final report listing grant expenditures signed by the financial officer or designee of the grantee within the deadline specified by the Department;</text> </paragraph> <paragraph num="(e)"> <text>Submit a final invoice for any unbilled expenditures within the deadline specified by the Department; and</text> </paragraph> <paragraph num="(f)"> <text>Submit a refund of any unexpended funds within the deadline specified by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may audit the accounts referenced in §B(1) of this regulation at any time.</text> </paragraph> <paragraph num="(3)"> <text>A grantee shall retain all records pertaining to a grant for 3 years from the date the final report is submitted under §B(1) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>In the case of an audit or litigation, the Department may extend the time period under §B(1) or (3) of this regulation until the completion of the audit or litigation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Progress Reports. A grantee shall submit to the Program:</text> <paragraph num="(1)"> <text>Interim reports describing the progress of the grant; and</text> </paragraph> <paragraph num="(2)"> <text>A comprehensive final report that provides a summary of all activities conducted under the grant no later than the deadline specified by the Department, including the:</text> <paragraph num="(a)"> <text>Number of individuals screened;</text> </paragraph> <paragraph num="(b)"> <text>Tests used;</text> </paragraph> <paragraph num="(c)"> <text>Cost of the tests; and</text> </paragraph> <paragraph num="(d)"> <text>Cancers detected by the tests.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Publications.</text> <paragraph num="(1)"> <text>A grantee who publishes results from activities supported by a grant approved under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program of the Maryland Department of Health.”</text> </paragraph> <paragraph num="(2)"> <text>A grantee shall provide the Department with one electronic copy of any published article associated with an activity conducted under a grant.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Ownership of Cancer Screening Tests. A grantee:</text> <paragraph num="(1)"> <text>Shall ensure that a cancer screening test purchased under a Program grant is used for the sole purpose of the grant;</text> </paragraph> <paragraph num="(2)"> <text>Shall keep an inventory of cancer screening tests purchased; and</text> </paragraph> <paragraph num="(3)"> <text>May not transfer a cancer screening test to another entity without written permission from the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Termination.</text> <paragraph num="(1)"> <text>The Department may terminate a grant:</text> <paragraph num="(a)"> <text>If a grantee fails to comply with:</text> <paragraph num="(i)"> <text>The requirements of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>State, federal, and municipal laws applicable to the grant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If a grantee fails to carry out the purposes for which the grant was awarded;</text> </paragraph> <paragraph num="(c)"> <text>In compliance with a court order; or</text> </paragraph> <paragraph num="(d)"> <text>At the request of the grantee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not be held responsible for any expenses incurred by a grantee after cancellation of a grant.</text> </paragraph> <paragraph num="(3)"> <text>The grantee shall return all unexpended funds to the Department within 30 days of termination of a grant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Liability.</text> <paragraph num="(1)"> <text>A grantee shall be solely responsible for its actions related to the:</text> <paragraph num="(a)"> <text>Program application process; and</text> </paragraph> <paragraph num="(b)"> <text>Activities conducted under a grant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not be held liable for any claims, losses, liabilities, expenses, or damages arising from activities related to the:</text> <paragraph num="(a)"> <text>Program application process; or</text> </paragraph> <paragraph num="(b)"> <text>Activities conducted under a grant.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 13, 2023 (50:22 Md. R. 975)</annotation> </annotations> </chapter> </subtitle> <subtitle num="15" heading="Food"> <chapter num="01" heading="Low Acid and Acidified Food canning"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>In this chapter, all provisions of 21 CFR 113 and 114 are incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acid foods” means foods that have a natural pH of 4.6 or below.</text> </paragraph> <paragraph num="(2)"> <text>Acidified Foods.</text> <paragraph num="(a)"> <text>“Acidified foods” means low-acid foods to which acid or acids or acid food or acid foods are added and that have a:</text> <paragraph num="(i)"> <text>Water activity (aw) greater than 0.85; and</text> </paragraph> <paragraph num="(ii)"> <text>Finished equilibrium pH of 4.6 or below.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Acidified foods” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in combination; and</text> </paragraph> <paragraph num="(ii)"> <text>Foods that are called, or may purport to be, “pickles” or “pickled”.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Acidified foods” does not include:</text> <paragraph num="(i)"> <text>Carbonated beverages, jams, jellies, or preserves;</text> </paragraph> <paragraph num="(ii)"> <text>Acid foods that contain small amounts of low-acid food or foods and have a resultant finished equilibrium pH that does not significantly differ from that of the predominate acid or acid food, including such foods as standardized and nonstandardized food dressings and condiment sauces; and</text> </paragraph> <paragraph num="(iii)"> <text>Foods that are stored, distributed, and retailed under refrigeration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Canned foods” means foods that are heat treated and hermetically sealed in a container for preservation.</text> </paragraph> <paragraph num="(4)"> <text>“Commercially sterile” means the condition achieved by the:</text> <paragraph num="(a)"> <text>Application of heat that renders the food free of:</text> <paragraph num="(i)"> <text>Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and</text> </paragraph> <paragraph num="(ii)"> <text>Viable microorganisms, including spores, that cause disease; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Control of water activity and the application of heat that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(7)"> <text>“Lot” means the product produced during a time period indicated by a specific code.</text> </paragraph> <paragraph num="(8)"> <text>Low-Acid Foods.</text> <paragraph num="(a)"> <text>“Low-acid foods” means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85.</text> </paragraph> <paragraph num="(b)"> <text>“Low-acid foods” does not include tomatoes and tomato products having a finished equilibrium pH less than 4.7.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Person-in-charge” means the licensee or other individual responsible for the overall conditions and operation of a cannery or acidified food processing plant.</text> </paragraph> <paragraph num="(10)"> <text>“Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements or the acidification and processing of acidified foods.</text> </paragraph> <paragraph num="(11)"> <text>“Scheduled process” means the process selected by the processor as adequate under the conditions of manufacture that:</text> <paragraph num="(a)"> <text>Is at a minimum equivalent to the process established by a process authority;</text> </paragraph> <paragraph num="(b)"> <text>For thermally processed low-acid foods packaged in hermetically sealed containers:</text> <paragraph num="(i)"> <text>Achieves a commercially sterile product; and</text> </paragraph> <paragraph num="(ii)"> <text>May be in excess of that necessary to ensure destruction of microorganisms that cause disease;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For acidified foods:</text> <paragraph num="(i)"> <text>Achieves and maintains a food that will not permit the growth of microorganisms that cause disease; and</text> </paragraph> <paragraph num="(ii)"> <text>Includes the control of pH and other critical factors; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For thermally processed acid foods packaged in hermetically sealed containers:</text> <paragraph num="(i)"> <text>Achieves a commercially sterile product; or</text> </paragraph> <paragraph num="(ii)"> <text>Ensures the destruction of microorganisms that cause disease and prevents spoilage during the product's shelf life.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Thermal process validation study” means a scientific study conducted by a process authority to determine critical factors and establish and validate a food process.</text> </paragraph> <paragraph num="(13)"> <text>“Water activity (aw)” means the measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conformance with Other Chapters."> <paragraph num="A."> <text>The person-in-charge shall ensure that a food processing plant is in compliance with this chapter and COMAR 10.15.04:</text> <paragraph num="(1)"> <text>In the design, operation, and maintenance of the plant, its facilities, and equipment; and</text> </paragraph> <paragraph num="(2)"> <text>When the plant is canning foods or manufacturing acidified foods, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding canning or acidified food manufacturing, this chapter takes precedence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licenses."> <paragraph num="A."> <text>In order to operate a cannery or acidified food processing plant, a person shall obtain a food processing license pursuant to the provisions of Health-General Article, §21-305, Annotated Code of Maryland, COMAR 10.15.04, and this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department shall specify on a food processing license issued to a cannery or acidified food processing plant the following type or types of food the licensee is approved to produce:</text> <paragraph num="(1)"> <text>Low-acid canned foods;</text> </paragraph> <paragraph num="(2)"> <text>Acidified foods;</text> </paragraph> <paragraph num="(3)"> <text>Acid canned foods; or</text> </paragraph> <paragraph num="(4)"> <text>A combination of these types.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Foods are not canned and acidified foods are not manufactured in the plant without the license required by Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The required food processing license is conspicuously posted in the plant during operations; and</text> </paragraph> <paragraph num="(3)"> <text>The food canned or manufactured is limited to the type or types of foods stated on the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Plant Facilities and Operations."> <paragraph num="A."> <text>The person-in-charge shall provide and properly maintain, in good working and sanitary condition, the equipment and facilities needed to can food and manufacture acidified foods in accordance with applicable regulations.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The sewerage system for the plant meets all applicable State and local codes and properly disposes of all wastewater;</text> </paragraph> <paragraph num="(3)"> <text>Individuals in the plant:</text> <paragraph num="(a)"> <text>Practice good personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>While working with food, wash their hands frequently and directly after an activity that is likely to soil their hands;</text> </paragraph> <paragraph num="(c)"> <text>Wear clean outerwear and no jewelry; and</text> </paragraph> <paragraph num="(d)"> <text>Do not smoke or engage in any activity that might contaminate food;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Food contact surfaces are effectively cleaned and sanitized:</text> <paragraph num="(a)"> <text>As often as needed to prevent food contamination; and</text> </paragraph> <paragraph num="(b)"> <text>At a minimum:</text> <paragraph num="(i)"> <text>Following processing;</text> </paragraph> <paragraph num="(ii)"> <text>Between an interruption in processing of greater than 2 hours; and</text> </paragraph> <paragraph num="(iii)"> <text>After a continuous use of 6 hours;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes;</text> </paragraph> <paragraph num="(6)"> <text>Non-food contact surfaces that:</text> <paragraph num="(a)"> <text>Receive splash or waste are cleaned and sanitized:</text> <paragraph num="(i)"> <text>As necessary to maintain a sanitary condition; and</text> </paragraph> <paragraph num="(ii)"> <text>At a minimum following each day's use; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Cleaning procedures are effective in removing soil and in preparing the surface for sanitizing when sanitizing is required;</text> </paragraph> <paragraph num="(8)"> <text>The sanitization of surfaces is effective in killing pathogens that may be present on the surface; and</text> </paragraph> <paragraph num="(9)"> <text>Clean equipment and utensils are stored to prevent their contamination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Equipment."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Processing equipment used to heat or cool food in hermetically sealed containers is:</text> <paragraph num="(1)"> <text>Designed to provide even and adequate processing;</text> </paragraph> <paragraph num="(2)"> <text>Provided adequate instrumentation and recording devices to allow process control, monitoring, and verification;</text> </paragraph> <paragraph num="(3)"> <text>Durable and impervious to water;</text> </paragraph> <paragraph num="(4)"> <text>Maintained in a sanitary and working condition;</text> </paragraph> <paragraph num="(5)"> <text>Monitored to verify that process requirements are met; and</text> </paragraph> <paragraph num="(6)"> <text>Calibrated according to a schedule approved by the Department;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Food equipment other than that used for heating and cooling food in hermetically sealed containers is:</text> <paragraph num="(1)"> <text>Non-toxic and does not impart any toxic or deleterious matter to the food;</text> </paragraph> <paragraph num="(2)"> <text>Corrosion resistant;</text> </paragraph> <paragraph num="(3)"> <text>Durable;</text> </paragraph> <paragraph num="(4)"> <text>Impervious; and</text> </paragraph> <paragraph num="(5)"> <text>Smooth and easily cleanable;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Non-food contact equipment that receives splash or waste is smooth and easily cleanable; and</text> </paragraph> <paragraph num="D."> <text>Steam that might contact food is culinary grade steam.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Manufacturing Practices for Low-Acid Food and Acidified Food Canning."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Low-acid foods are processed and labeled in accordance with 21 CFR 113;</text> </paragraph> <paragraph num="B."> <text>Acidified foods are processed and labeled in accordance with 21 CFR 114;</text> </paragraph> <paragraph num="C."> <text>When canning is taking place, a scheduled process is used that takes into account the critical factors and limits that are likely to influence the food’s safety, stability, or shelf life, such as:</text> <paragraph num="(1)"> <text>Food characteristics;</text> </paragraph> <paragraph num="(2)"> <text>Spoilage organisms;</text> </paragraph> <paragraph num="(3)"> <text>Time and temperature of thermal process;</text> </paragraph> <paragraph num="(4)"> <text>Cooling parameters;</text> </paragraph> <paragraph num="(5)"> <text>Acidification;</text> </paragraph> <paragraph num="(6)"> <text>Storage conditions;</text> </paragraph> <paragraph num="(7)"> <text>Design and performance of the processing equipment; and</text> </paragraph> <paragraph num="(8)"> <text>Batch size and configuration;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before a food processing plant processes food in a closed vessel, such as a retort or steam cabinet, a process authority performs a thermal process validation study that includes:</text> <paragraph num="(1)"> <text>Heat penetration tests;</text> </paragraph> <paragraph num="(2)"> <text>Heat distribution tests;</text> </paragraph> <paragraph num="(3)"> <text>Cooling parameters; and</text> </paragraph> <paragraph num="(4)"> <text>Any other measurements, observations, or calculations needed to ensure that the process is effective and reliable;</text> </paragraph> </paragraph> <paragraph num="E."> <text>The scheduled thermal process and validation study are re-established each time there is a change in the processing system; and</text> </paragraph> <paragraph num="F."> <text>All thermal processes and validation studies being used are available for inspection by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Manufacturing Practices for Acid Food Canning — Repealed." /> <regulation prefix="Regulation" num=".09" heading="Process Controls in Low Acid and Acidified Food Canning."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The canning process is monitored and controlled as necessary to ensure the food's safety, stability, and shelf life;</text> </paragraph> <paragraph num="B."> <text>The cook time, cook temperatures, and pH of each batch of canned food are measured and recorded;</text> </paragraph> <paragraph num="C."> <text>Through strict processing criteria, monitoring, record keeping, and corrective action, a container of food processed as an acidified food is not distributed if the final pH measurement of the food is greater than 4.6 (4.7 for tomatoes and tomato products) when the food’s water activity is greater than 0.85;</text> </paragraph> <paragraph num="D."> <text>Sealing and seaming closure inspections are conducted to verify that containers are properly hermetically sealed;</text> </paragraph> <paragraph num="E."> <text>When a deviation from the scheduled process occurs:</text> <paragraph num="(1)"> <text>The food manufactured during the deviation is:</text> <paragraph num="(a)"> <text>Held for evaluation by a process authority; and</text> </paragraph> <paragraph num="(b)"> <text>Completely reprocessed, destroyed, released, or otherwise disposed of in accordance with the decision of the process authority; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The deviation and associated corrective action is documented in a record;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Records are maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use; and</text> </paragraph> <paragraph num="G."> <text>The records required in §§B, C, E, and F of this regulation are retained for at least 3 years from the date of manufacturing and are available for inspection by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Labeling and Marking of Containers."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Canned food is conspicuously and prominently labeled or marked with the following information:</text> <paragraph num="(1)"> <text>The common name of the food;</text> </paragraph> <paragraph num="(2)"> <text>The list of ingredients in descending order of prominence by weight;</text> </paragraph> <paragraph num="(3)"> <text>The name and address of the manufacturer or distributor; and</text> </paragraph> <paragraph num="(4)"> <text>The net weight of the container;</text> </paragraph> </paragraph> <paragraph num="B."> <text>For a container marked with the name of the distributor, the name of the distributor is:</text> <paragraph num="(1)"> <text>Preceded by the words “packed for” or “distributed by”; or</text> </paragraph> <paragraph num="(2)"> <text>Followed by the word “distributor”;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A container of canned low acid or acidified food is marked with a permanently visible identifying code that is:</text> <paragraph num="(1)"> <text>Embossed or inked on the container; or</text> </paragraph> <paragraph num="(2)"> <text>Perforated or otherwise marked on a label securely affixed to the product container, if the container does not allow embossing or inking;</text> </paragraph> </paragraph> <paragraph num="D."> <text>The identifying code required in §C of this regulation:</text> <paragraph num="(1)"> <text>Specifies the following:</text> <paragraph num="(a)"> <text>The establishment where the product was packed;</text> </paragraph> <paragraph num="(b)"> <text>The product contained in the container; and</text> </paragraph> <paragraph num="(c)"> <text>The year, day, and time period during which the product was packed; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is changed:</text> <paragraph num="(a)"> <text>Every 4 to 5 hours;</text> </paragraph> <paragraph num="(b)"> <text>With a personnel shift change;</text> </paragraph> <paragraph num="(c)"> <text>With each batch, as long as the containers that constitute a batch do not extend over a period of more than one personnel shift; or</text> </paragraph> <paragraph num="(d)"> <text>Otherwise often enough to enable ready identification of a lot during its sale and distribution;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A container of product that needs to be refrigerated after opening to provide safety, stability, or shelf life is prominently and conspicuously marked with the statement “refrigerate after opening” or an equivalent statement; and</text> </paragraph> <paragraph num="F."> <text>False or misleading information is not placed on a container.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-340, and 21-350, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 18, 1957</annotation> <annotation type="History" subtype="Administrative History">Chapter, Canneries, repealed effective January 22, 2001 (28:1 Md. R. 26)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10, Canning and Acidified Food Manufacturing, adopted effective January 22, 2001 (28:1 Md. R. 26)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Canning and Acidified Food Manufacturing, renamed, Low Acid and Acidified Food Canning, effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> </annotations> </chapter> <chapter num="02" heading="Crab Meat"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Back” means to remove a crab's outer shell.</text> </paragraph> <paragraph num="(2)"> <text>“Boiled” means cooked by boiling in water that is bubbling rapidly, greatly agitated, and at a temperature of 212°F at sea level.</text> </paragraph> <paragraph num="(3)"> <text>“Chum” means the parts of a cooked crab that are not eaten, and that are disposed of as waste material.</text> </paragraph> <paragraph num="(4)"> <text>“Crab meat” means the edible meat of cooked crabs.</text> </paragraph> <paragraph num="(5)"> <text>“Crab meat plant” means:</text> <paragraph num="(a)"> <text>A picking plant; or</text> </paragraph> <paragraph num="(b)"> <text>A place where crab meat is heat-treated to improve the keeping quality of the crab meat.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(8)"> <text>“Fresh crab meat” means cooked crab meat that has not been pasteurized or frozen.</text> </paragraph> <paragraph num="(9)"> <text>“HACCP plan” means a Hazard Analysis Critical Control Point (HACCP) plan as specified in COMAR 10.15.10.</text> </paragraph> <paragraph num="(10)"> <text>“Pasteurized crab meat” means cooked crab meat that is sealed in a container and further heat processed to improve the keeping quality of the meat.</text> </paragraph> <paragraph num="(11)"> <text>“Person-in-charge” means the licensee or other person responsible for the operation of the crab meat plant.</text> </paragraph> <paragraph num="(12)"> <text>“Picking plant” means a place where:</text> <paragraph num="(a)"> <text>Crabs are cooked;</text> </paragraph> <paragraph num="(b)"> <text>Crab meat is picked from crabs; and</text> </paragraph> <paragraph num="(c)"> <text>Crab meat is packed for sale.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements for crabs and crab meat.</text> </paragraph> <paragraph num="(14)"> <text>“Repack crab meat” means to pack crab meat by taking it from a container or package, when the crab meat has been picked from a crab at another location, and placing that crab meat in another container or package.</text> </paragraph> <paragraph num="(15)"> <text>“Scheduled process” means a method or set of procedures determined by a process authority for processing crabs and crab meat, which takes into account the critical factors that may impact the food's safety or stability.</text> </paragraph> <paragraph num="(16)"> <text>“Steamed” means cooked by exposure to steam in a cooker with the steam:</text> <paragraph num="(a)"> <text>Under pressure, so that the temperature of the steam is greater than 212°F at sea level; or</text> </paragraph> <paragraph num="(b)"> <text>At atmospheric pressure in a non-pressurized cooker.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference — Repealed." /> <regulation prefix="Regulation" num=".03" heading="Compliance with Other Chapters."> <paragraph num="A."> <text>The person-in-charge shall process crab meat and design, operate, and maintain a crab meat plant, its facilities, and equipment in compliance with this chapter and COMAR 10.15.04 and 10.15.10.</text> </paragraph> <paragraph num="B."> <text>If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding crab meat plants or the processing of crab meat, this chapter takes precedence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licenses."> <paragraph num="A."> <text>In order to operate a crab meat plant, a person shall obtain a food processing license pursuant to the provisions of:</text> <paragraph num="(1)"> <text>Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.15.04; and</text> </paragraph> <paragraph num="(3)"> <text>This chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall specify on a food processing license it issues to a person operating a crab meat plant that the licensee is approved to process:</text> <paragraph num="(1)"> <text>Fresh crab meat;</text> </paragraph> <paragraph num="(2)"> <text>Pasteurized crab meat;</text> </paragraph> <paragraph num="(3)"> <text>Repacked crab meat; or</text> </paragraph> <paragraph num="(4)"> <text>Any combination of the above types of crab meat.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Crab meat is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The required food processing license is conspicuously posted in the plant; and</text> </paragraph> <paragraph num="(3)"> <text>The operations in the plant are limited to the type of crab meat operation specified on the license pursuant to §B of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Plant Facilities."> <paragraph num="A."> <text>The person-in-charge shall ensure that the equipment and facilities needed to process crab meat in accordance with the requirements of this chapter are provided and maintained in a sanitary and working condition.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The sewage disposal system for the plant meets all applicable State and local codes and properly disposes of all wastewater;</text> </paragraph> <paragraph num="(3)"> <text>Ice used in the manufacture of crab meat is produced from water that is potable and meets the requirements of the Environment Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>The plant design and the flow of food through the plant minimize the potential for cross-contamination;</text> </paragraph> <paragraph num="(5)"> <text>If uncooked crabs will be stored at the plant for more than 4 hours before cooking, a separate cooler is provided for uncooked crabs;</text> </paragraph> <paragraph num="(6)"> <text>Partitions or linear distances are used to separate cooking areas, picking areas, and packing areas;</text> </paragraph> <paragraph num="(7)"> <text>Floors in all processing areas and in refrigerated rooms are sloped to accessible floor drains that dispose of wastewater, in compliance with applicable plumbing codes;</text> </paragraph> <paragraph num="(8)"> <text>Toilet rooms:</text> <paragraph num="(a)"> <text>Are provided at the rate of one toilet for every 20 employees;</text> </paragraph> <paragraph num="(b)"> <text>Do not open directly into a food processing or storage area; and</text> </paragraph> <paragraph num="(c)"> <text>Are:</text> <paragraph num="(i)"> <text>Separate for men and women; or</text> </paragraph> <paragraph num="(ii)"> <text>Designed for use by not more than one person at a time.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>A hand sink is:</text> <paragraph num="(a)"> <text>Provided in the picking area at the rate of one hand sink for each 15 pickers;</text> </paragraph> <paragraph num="(b)"> <text>Provided in the packing area;</text> </paragraph> <paragraph num="(c)"> <text>Equipped with soap and paper towels for drying hands;</text> </paragraph> <paragraph num="(d)"> <text>Accompanied by sanitizer in the picking and packing rooms for the sanitizing of hands; and</text> </paragraph> <paragraph num="(e)"> <text>Equipped with hot and cold water under pressure;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A picking table is:</text> <paragraph num="(a)"> <text>Adequate in size so that a picker does not contaminate crab meat during the picking of cooked crabs; and</text> </paragraph> <paragraph num="(b)"> <text>Provided with sanitary paper towels in a dispenser within reach of a picker while at the table;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>A three-compartment sink is:</text> <paragraph num="(a)"> <text>Designed to allow immersion of utensils or equipment that will be cleaned and sanitized in the sink;</text> </paragraph> <paragraph num="(b)"> <text>Provided in the plant for washing, rinsing, and sanitizing equipment and utensils; and</text> </paragraph> <paragraph num="(c)"> <text>Equipped with hot and cold water under pressure; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Waste containers are:</text> <paragraph num="(a)"> <text>Provided inside the facility to be accessible to the workers;</text> </paragraph> <paragraph num="(b)"> <text>Made to be easily cleanable;</text> </paragraph> <paragraph num="(c)"> <text>Large enough to hold waste until the waste is taken off-site if the containers are outside waste containers; and</text> </paragraph> <paragraph num="(d)"> <text>Vermin-proof, insect-proof, and placed on a hard and impermeable surface if the containers are outdoor waste containers, except in the case of chum containers that are removed daily.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge may use a two-compartment sink instead of the three-compartment sink required in §B(11)(b) of this regulation, if the two-compartment sink:</text> <paragraph num="(1)"> <text>Was installed before the effective date of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Complies with all regulations applicable before the effective date of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Performs the intended function;</text> </paragraph> <paragraph num="(4)"> <text>Is maintained in a sanitary condition; and</text> </paragraph> <paragraph num="(5)"> <text>When replaced, is replaced with a hand sink or three-compartment sink in full compliance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Plant Sanitation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Individuals in the plant:</text> <paragraph num="(1)"> <text>Practice good personal hygiene;</text> </paragraph> <paragraph num="(2)"> <text>Are excluded from working with food when the individuals are sick with an illness that is transmittable through food;</text> </paragraph> <paragraph num="(3)"> <text>While working with food, wash the individuals' hands frequently and after an activity that is likely to soil the hands;</text> </paragraph> <paragraph num="(4)"> <text>Wear clean outerwear, hair coverings, and no jewelry;</text> </paragraph> <paragraph num="(5)"> <text>If handling crabs or crab meat, maintain trim and clean fingernails, and do not wear false fingernails;</text> </paragraph> <paragraph num="(6)"> <text>Store personal items in a designated non-food area; and</text> </paragraph> <paragraph num="(7)"> <text>Do not smoke or engage in an activity that might contaminate food;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Picking trays, knives, and gloves are washed, rinsed, and sanitized before use and after each delivery of crab meat to the packing room;</text> </paragraph> <paragraph num="C."> <text>Except as provided in §B of this regulation, food contact surfaces are cleaned and sanitized:</text> <paragraph num="(1)"> <text>As often as needed to prevent food contamination; and</text> </paragraph> <paragraph num="(2)"> <text>At a minimum:</text> <paragraph num="(a)"> <text>Following processing; and</text> </paragraph> <paragraph num="(b)"> <text>Between an interruption in processing of greater than 2 hours;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>During processing, gross soil is removed from food contact surfaces and the surfaces are sanitized:</text> <paragraph num="(1)"> <text>After a continuous use of 6 hours; and</text> </paragraph> <paragraph num="(2)"> <text>After an interruption in processing of greater than 30 minutes;</text> </paragraph> </paragraph> <paragraph num="E."> <text>When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes;</text> </paragraph> <paragraph num="F."> <text>Non-food contact surfaces that receive splash or waste are cleaned and sanitized:</text> <paragraph num="(1)"> <text>As often as necessary to maintain a sanitary condition; and</text> </paragraph> <paragraph num="(2)"> <text>At a minimum following each day's use;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Cleaning procedures:</text> <paragraph num="(1)"> <text>Include the use of detergents or other cleaning chemicals; and</text> </paragraph> <paragraph num="(2)"> <text>Remove soils;</text> </paragraph> </paragraph> <paragraph num="H."> <text>The sanitization of surfaces is effective in killing pathogens on the treated surface;</text> </paragraph> <paragraph num="I."> <text>Non-food contact surfaces that do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition;</text> </paragraph> <paragraph num="J."> <text>Before cleaning, all food and food packaging is removed from the area being cleaned;</text> </paragraph> <paragraph num="K."> <text>Cleaning and sanitizing occur in a manner that protects food from contamination;</text> </paragraph> <paragraph num="L."> <text>In-use and cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils;</text> </paragraph> <paragraph num="M."> <text>Waste, including chum, is held in a sanitary manner and disposed of to maintain the plant grounds in a sanitary condition; and</text> </paragraph> <paragraph num="N."> <text>Outdoor containers for chum that are not vermin-proof or insect-proof are removed daily and transported to a disposal site.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Equipment."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Processing equipment is:</text> <paragraph num="(1)"> <text>Designed to provide even and effective processing;</text> </paragraph> <paragraph num="(2)"> <text>Provided with instrumentation to allow process control, monitoring, and verification;</text> </paragraph> <paragraph num="(3)"> <text>Durable and impervious to water;</text> </paragraph> <paragraph num="(4)"> <text>Maintained in a sanitary and working condition;</text> </paragraph> <paragraph num="(5)"> <text>Monitored to verify that process requirements are met; and</text> </paragraph> <paragraph num="(6)"> <text>Calibrated to ensure accuracy;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pasteurization equipment is provided with:</text> <paragraph num="(1)"> <text>Temperature sensors:</text> <paragraph num="(a)"> <text>For controlling and documenting the thermal process; and</text> </paragraph> <paragraph num="(b)"> <text>That are located to give an accurate representation of the heating medium's temperature;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An automatic recording device of time and temperature that is:</text> <paragraph num="(a)"> <text>Equipped with a reliable clock, so that a recorded interval does not exceed the elapsed time indicated by an accurate time piece; and</text> </paragraph> <paragraph num="(b)"> <text>Equipped with a temperature measuring device that is scaled at a maximum of 2°F intervals within the operating temperature range of the pasteurization equipment and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the pasteurization equipment with an accuracy of ±1°F within the range spanning ±15°F of the target processing temperature;</text> </paragraph> <paragraph num="(4)"> <text>Adequate agitation for even heating and cooling; and</text> </paragraph> <paragraph num="(5)"> <text>Cooling water that contains residual free chlorine throughout the cooling process;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A vessel for steaming crabs is provided with:</text> <paragraph num="(1)"> <text>An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the vessel and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature;</text> </paragraph> <paragraph num="(2)"> <text>Vents to exhaust air thoroughly;</text> </paragraph> <paragraph num="(3)"> <text>A bottom drain;</text> </paragraph> <paragraph num="(4)"> <text>Steam pipe inlets or spreaders for even steam distribution; and</text> </paragraph> <paragraph num="(5)"> <text>Culinary grade steam of sufficient volume for processing;</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to what is required in §C of this regulation, a pressurized vessel is provided with:</text> <paragraph num="(1)"> <text>When pressure is part of a standardized process, a pressure gauge; and</text> </paragraph> <paragraph num="(2)"> <text>A pressure relief valve as required for safety;</text> </paragraph> </paragraph> <paragraph num="E."> <text>An accurate clock or timer is provided in the immediate vicinity of a heat-processing vessel to allow the accurate measurement of process time;</text> </paragraph> <paragraph num="F."> <text>Equipment used to process crab meat has food contact surfaces that are:</text> <paragraph num="(1)"> <text>Non-toxic and do not impart toxic or deleterious matter to the food;</text> </paragraph> <paragraph num="(2)"> <text>Corrosion resistant;</text> </paragraph> <paragraph num="(3)"> <text>Durable;</text> </paragraph> <paragraph num="(4)"> <text>Impervious; and</text> </paragraph> <paragraph num="(5)"> <text>Smooth and easily cleanable;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Tables used to back and pick crabs, and pack crab meat and food are made of stainless steel of American Iron and Steel Institute Type 304, or the equivalent; and</text> </paragraph> <paragraph num="H."> <text>Non-food contact equipment that receives splash or waste is smooth and easily cleanable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Processing Practices."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Crab meat is processed using sanitary practices, process controls, and a HACCP plan in compliance with COMAR 10.15.10;</text> </paragraph> <paragraph num="B."> <text>A process used for crab cooking or pasteurization is at least equivalent to a scheduled process;</text> </paragraph> <paragraph num="C."> <text>The scheduled process:</text> <paragraph num="(1)"> <text>Is maintained in writing and available on-site;</text> </paragraph> <paragraph num="(2)"> <text>Provides the heat lethality and rate of cooling prescribed in this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Establishes the time and temperature requirements for the processing system, which may include the:</text> <paragraph num="(a)"> <text>Minimum time for exhausting air from the cooking or pasteurization vessel and a target temperature and pressure at the end of the exhaust;</text> </paragraph> <paragraph num="(b)"> <text>Minimum processing temperature;</text> </paragraph> <paragraph num="(c)"> <text>Minimum processing time after the cooking or pasteurization vessel reaches processing temperature; and</text> </paragraph> <paragraph num="(d)"> <text>Cooling parameters;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Takes into account factors in the process that are likely to affect the lethality of the thermal process and the rate of cooling, which for pasteurization may include the:</text> <paragraph num="(a)"> <text>Design and performance of the processing equipment;</text> </paragraph> <paragraph num="(b)"> <text>Initial food temperature;</text> </paragraph> <paragraph num="(c)"> <text>Batch size and configuration; and</text> </paragraph> <paragraph num="(d)"> <text>Size and the shape of the crab meat container;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Is re-standardized each time there is a change in the processing system; and</text> </paragraph> <paragraph num="(6)"> <text>Allows process monitoring;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A thermometer used in conjunction with a cooking or pasteurization vessel is calibrated at least annually, or is certified by the National Institute of Standards and Technology with a valid certificate; and</text> </paragraph> <paragraph num="E."> <text>If pressure is part of the scheduled process, a pressure gauge, used in conjunction with a cooking or pasteurization vessel is calibrated at least annually.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Unit Processing Operations — Cooking."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Live crabs received at the plant are stored in a manner that enhances the crab's survival and prevents decomposition;</text> </paragraph> <paragraph num="B."> <text>Crabs are steamed using a standardized process:</text> <paragraph num="(1)"> <text>For a heat lethality equivalent to F(235°F) = 1 minute with z = 15°F, which is equivalent to bringing the internal temperature of the crabs instantaneously to 235°F, holding the internal temperature at 235°F for 1 minute, and then instantaneously cooling the crabs; or</text> </paragraph> <paragraph num="(2)"> <text>Other than the one set forth in §B(1) of this regulation, if the alternative process has been shown through scientific study to provide:</text> <paragraph num="(a)"> <text>Pathogen lethality; and</text> </paragraph> <paragraph num="(b)"> <text>Equivalent conformance with the bacteriological standards set forth in Regulation .15 of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The cooling of cooked crabs conforms with the following:</text> <paragraph num="(1)"> <text>Except as provided in Regulation .10C of this chapter, air cooling of cooked crabs at ambient air temperatures does not exceed more than 4 hours in length;</text> </paragraph> <paragraph num="(2)"> <text>When cooked crabs are refrigerated before picking, the cooked crabs are placed in refrigeration at 40°F or below after cooling at ambient air temperatures; and</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in §D of this regulation, cooked crabs are:</text> <paragraph num="(a)"> <text>Cooled and held before picking with the outer shell in place; and</text> </paragraph> <paragraph num="(b)"> <text>Backed immediately before picking; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In order to provide a cold water rinse to remove sediment, when cooked dredged crabs are backed:</text> <paragraph num="(1)"> <text>Before refrigeration, the crabs are air cooled, backed, and refrigerated within 4 hours after cooking;</text> </paragraph> <paragraph num="(2)"> <text>After refrigeration, the crabs are backed, rinsed, and picked and the crab meat packed in:</text> <paragraph num="(a)"> <text>A continuous process; and</text> </paragraph> <paragraph num="(b)"> <text>Accordance with Regulation .10B of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>With no refrigeration and directly before picking the cooked crabs are cooled, backed, and picked and the crab meat packed in:</text> <paragraph num="(a)"> <text>A continuous process; and</text> </paragraph> <paragraph num="(b)"> <text>Accordance with Regulation .10C of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Unit Processing Operations — Picking and Packing."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Cooked crabs are transferred to the pickers in containers dedicated to that purpose;</text> </paragraph> <paragraph num="B."> <text>For cooked crabs that are refrigerated before picking, within 3.5 hours after the crabs are removed from refrigeration, the:</text> <paragraph num="(1)"> <text>Crabs are picked; and</text> </paragraph> <paragraph num="(2)"> <text>Packed crab meat is cooled by:</text> <paragraph num="(a)"> <text>Surrounding the packed crab meat with ice; or</text> </paragraph> <paragraph num="(b)"> <text>Another effective and sanitary cooling method;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>For cooked crabs that are not refrigerated before picking, within 6 hours after the crabs are cooked, the:</text> <paragraph num="(1)"> <text>Crabs are picked; and</text> </paragraph> <paragraph num="(2)"> <text>Packed crab meat is cooled by:</text> <paragraph num="(a)"> <text>Surrounding the packed crab meat with ice; or</text> </paragraph> <paragraph num="(b)"> <text>Another effective and sanitary cooling method;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The corrective action for crab meat that is not picked, packed, and iced or otherwise cooled within HACCP critical limits is documented in records;</text> </paragraph> <paragraph num="E."> <text>Containers in which crab meat is picked and packed are:</text> <paragraph num="(1)"> <text>Made of suitable food-grade materials;</text> </paragraph> <paragraph num="(2)"> <text>Protected from contamination; and</text> </paragraph> <paragraph num="(3)"> <text>Rinsed in a bactericidal solution and completely drained immediately before being filled with crab meat; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Crab meat picked in the plant is not removed from the container into which it was picked and placed into another container, except when specific written approval for the transfer of crab meat from the original container into another container is given by the Department, based on a review of a written proposal plan to transfer the crab meat that complies with this chapter and includes the:</text> <paragraph num="(1)"> <text>Type or types of crab meat to be placed from one container into another container;</text> </paragraph> <paragraph num="(2)"> <text>Procedures to maintain the crab meat at temperatures that prevent the growth of pathogens and retard spoilage;</text> </paragraph> <paragraph num="(3)"> <text>HACCP plan for the process, if a hazard analysis indicates that reasonably likely food safety hazards exist;</text> </paragraph> <paragraph num="(4)"> <text>Food-grade specifications of a crab meat container;</text> </paragraph> <paragraph num="(5)"> <text>Oxygen permeability of a crab meat container;</text> </paragraph> <paragraph num="(6)"> <text>Procedures to protect crab meat from contamination; and</text> </paragraph> <paragraph num="(7)"> <text>Labeling and marking of a crab meat container.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Unit Processing Operations — Repacking."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Crab meat is repacked only in a licensed picking plant;</text> </paragraph> <paragraph num="B."> <text>Repacking does not occur except when written approval for the repacking is given by the Department, based on a review of a written proposal plan to repack that complies with this chapter, and includes the:</text> <paragraph num="(1)"> <text>Information in Regulation .10G of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>If imported crab meat will be repacked, name of the person responsible for ensuring compliance with §H(7) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Source of the crab meat;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Frozen crab meat is not repacked;</text> </paragraph> <paragraph num="D."> <text>Crab meat that is repacked into a container is:</text> <paragraph num="(1)"> <text>From a single plant; and</text> </paragraph> <paragraph num="(2)"> <text>Completely comprised of crab meat that was picked, packed, or pasteurized on the same day;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Once repacked, crab meat is not repacked again;</text> </paragraph> <paragraph num="F."> <text>An empty container from which crab meat has been repacked is placed immediately into a waste disposal receptacle and is not kept on the premises for reuse;</text> </paragraph> <paragraph num="G."> <text>Repacking is done in a sanitary manner in accordance with the provisions of this chapter;</text> </paragraph> <paragraph num="H."> <text>Crab meat for repacking is:</text> <paragraph num="(1)"> <text>Processed in a licensed plant operating under a HACCP plan;</text> </paragraph> <paragraph num="(2)"> <text>Wholesome;</text> </paragraph> <paragraph num="(3)"> <text>Received in its original container and marked with the date of pasteurization as required in Regulation .14 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Crab meat that meets the bacteriological standards in Regulation .15 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>If pasteurized, stored at 40°F or below before repacking;</text> </paragraph> <paragraph num="(6)"> <text>When fresh:</text> <paragraph num="(a)"> <text>Repacked within 72 hours of the original pick and pack; and</text> </paragraph> <paragraph num="(b)"> <text>Stored in ice or held at 40°F or less before repacking; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>When imported crab meat, sampled and tested for Standard Plate Count and Escherichia coli by an accredited laboratory using a composite sample from 5 separate containers and standard methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Repacked crab meat not for pasteurization is:</text> <paragraph num="(1)"> <text>Maintained at 40°F or below during repacking; and</text> </paragraph> <paragraph num="(2)"> <text>Rapidly cooled after repacking by surrounding the packed crab meat in ice or some other sanitary and effective means;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Repacked crab meat for pasteurization is:</text> <paragraph num="(1)"> <text>Maintained at 40°F or below during repacking and in storage before pasteurization;</text> </paragraph> <paragraph num="(2)"> <text>Pasteurized within 96 hours of the original pick and pack; and</text> </paragraph> <paragraph num="(3)"> <text>Pasteurized, cooled, and stored in accordance with Regulations .08, .12, and .13 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="K."> <text>Repack records:</text> <paragraph num="(1)"> <text>Are maintained to allow crab meat to be traced to the original picking plant;</text> </paragraph> <paragraph num="(2)"> <text>Include the following information:</text> <paragraph num="(a)"> <text>The name, address, and plant number of the original picking plant;</text> </paragraph> <paragraph num="(b)"> <text>The type and quantity of the crab meat that is repacked;</text> </paragraph> <paragraph num="(c)"> <text>The original pick, pack, or pasteurization date and the repack date; and</text> </paragraph> <paragraph num="(d)"> <text>Results of the microbiological laboratory testing required in Regulation .11H(7) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Are available for inspection by the Department for 2 years following the date of repacking.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Unit Processing Operations — Pasteurization."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>When crab meat is picked in one plant for pasteurization at another:</text> <paragraph num="(1)"> <text>The crab meat is transported in the final container;</text> </paragraph> <paragraph num="(2)"> <text>A temporary cover that effectively protects the crab meat is placed on the can until seaming or sealing when the crab meat container will be seamed or sealed at a plant other than where it was filled; and</text> </paragraph> <paragraph num="(3)"> <text>The final product is labeled according to the requirements of Regulation .14 of this chapter;</text> </paragraph> </paragraph> <paragraph num="B."> <text>When a container is hermetically sealed:</text> <paragraph num="(1)"> <text>The container is covered or otherwise protected before sealing or seaming; and</text> </paragraph> <paragraph num="(2)"> <text>At a minimum, the seals or seams are inspected:</text> <paragraph num="(a)"> <text>At the start of sealing or seaming;</text> </paragraph> <paragraph num="(b)"> <text>At a minimum of every 4 hours during sealing and seaming; and</text> </paragraph> <paragraph num="(c)"> <text>When the sealing or seaming equipment malfunctions;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Crab meat that has been placed in containers and the containers sealed or seamed for pasteurization:</text> <paragraph num="(1)"> <text>Is pasteurized within 48 hours of sealing or seaming; and</text> </paragraph> <paragraph num="(2)"> <text>Receives a standardized process for a heat lethality equivalent to F(185°F) = 31 minutes with z = 16°F;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Immediately following pasteurization, pasteurized crab meat is continuously cooled to 55°F within 3 hours and to 40°F within an additional 15 hours;</text> </paragraph> <paragraph num="E."> <text>When a recording chart is used to record the time and temperature of pasteurization:</text> <paragraph num="(1)"> <text>A continuous inked record is made of process time and temperature during pasteurization;</text> </paragraph> <paragraph num="(2)"> <text>A new chart or section of chart is used for each pasteurization operation;</text> </paragraph> <paragraph num="(3)"> <text>The used charts that document a pasteurization process are kept on file in the plant, and available for inspection by the Department for a period of 2 years; and</text> </paragraph> <paragraph num="(4)"> <text>The following information is placed on the recorder chart form or another comparable form that documents that a pasteurization process is used:</text> <paragraph num="(a)"> <text>Process date;</text> </paragraph> <paragraph num="(b)"> <text>Plant name and number;</text> </paragraph> <paragraph num="(c)"> <text>Batch code;</text> </paragraph> <paragraph num="(d)"> <text>Quantity of each batch;</text> </paragraph> <paragraph num="(e)"> <text>Initial temperature of the crab meat when the temperature is a critical factor;</text> </paragraph> <paragraph num="(f)"> <text>Indicating thermometer reading after the target temperature has been reached and stabilized;</text> </paragraph> <paragraph num="(g)"> <text>Occurrence of any mechanical or power failure or the opening of the recording thermometer case for adjustments or repair during a thermal process cycle; and</text> </paragraph> <paragraph num="(h)"> <text>Written signature of the operator of the pasteurization equipment; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>When a computer-based data logger or data acquisition device is used to record the time and temperature of pasteurization, the information required in §E(4) of this regulation is:</text> <paragraph num="(1)"> <text>Recorded; and</text> </paragraph> <paragraph num="(2)"> <text>Available as a permanent copy for inspection by the Department for a period of 2 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Unit Processing Operations — Storage."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>After being picked and packed in ice, blast chilled, or otherwise cooled in a sanitary and effective way, fresh crab meat is kept in ice or in an ambient air temperature of 40°F or less;</text> </paragraph> <paragraph num="B."> <text>Except when pasteurized within 2.5 hours of weigh-up in the packing room, packed crab meat for pasteurization is kept in ice or in an ambient air temperature of 40°F or below until pasteurization;</text> </paragraph> <paragraph num="C."> <text>Pasteurized crab meat in hermetically sealed containers is kept in an ambient air temperature of 38°F or below;</text> </paragraph> <paragraph num="D."> <text>Reduced oxygen packaged non-pasteurized crab meat is kept frozen; and</text> </paragraph> <paragraph num="E."> <text>Crab meat is protected from contamination during storage.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Labeling and Marking of Crab Meat Containers."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The information required on a container of crab meat is marked by:</text> <paragraph num="(1)"> <text>Embossing;</text> </paragraph> <paragraph num="(2)"> <text>Imprinting;</text> </paragraph> <paragraph num="(3)"> <text>Lithography; or</text> </paragraph> <paragraph num="(4)"> <text>Another method approved by the Department based on its:</text> <paragraph num="(a)"> <text>Durability; and</text> </paragraph> <paragraph num="(b)"> <text>Ability to remain on the container for the shelf life of the crab meat in a form that is:</text> <paragraph num="(i)"> <text>Conspicuous; and</text> </paragraph> <paragraph num="(ii)"> <text>Legible;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The following information is marked on a container of crab meat:</text> <paragraph num="(1)"> <text>The common name of the food;</text> </paragraph> <paragraph num="(2)"> <text>The name and address of the picking plant or distributor;</text> </paragraph> <paragraph num="(3)"> <text>If a chemical is added to the crab meat, a statement to that effect;</text> </paragraph> <paragraph num="(4)"> <text>The license number of the plant preceded by the State abbreviation applicable to the picking plant; and</text> </paragraph> <paragraph num="(5)"> <text>The net weight of the contents of the container;</text> </paragraph> </paragraph> <paragraph num="C."> <text>For a container marked with the name of the distributor, the name of the distributor is:</text> <paragraph num="(1)"> <text>Preceded by the words “packed for” or “distributed by”; or</text> </paragraph> <paragraph num="(2)"> <text>Followed by the word “distributor”;</text> </paragraph> </paragraph> <paragraph num="D."> <text>When the packing and pasteurization are completed at different plants, the label clearly states the license numbers of the packer and pasteurizer;</text> </paragraph> <paragraph num="E."> <text>For a container of pasteurized crab meat, whenever the term “crab meat” or its equivalent appears on the label, the word “pasteurized” is stated with equal prominence and in immediate conjunction with the term “crab meat”;</text> </paragraph> <paragraph num="F."> <text>A container of pasteurized crab meat is marked with a batch code that indicates the date of picking, packing, or pasteurization;</text> </paragraph> <paragraph num="G."> <text>Except when crab meat is frozen, the words “keep refrigerated” or equivalent words are placed on a container of fresh or pasteurized crab meat;</text> </paragraph> <paragraph num="H."> <text>The words “keep frozen” or equivalent words are prominently displayed on the label of a container of frozen crab meat;</text> </paragraph> <paragraph num="I."> <text>If crab meat is in a frozen state after being manufactured, processed, or packaged and it then is offered for sale in an unfrozen state, the container's labeling contains a clear and conspicuous statement that the crab meat was previously frozen and should not be refrozen;</text> </paragraph> <paragraph num="J."> <text>A container of crab meat containing crab meat picked from a crab, packed, repacked, or processed outside of the United States:</text> <paragraph num="(1)"> <text>Is marked with the words “This product contains crab meat from (name of country of origin)”; and</text> </paragraph> <paragraph num="(2)"> <text>The marking required in §J(1) of this regulation is prominently displayed in letters not smaller than 12-point type on the principal display panel;</text> </paragraph> </paragraph> <paragraph num="K."> <text>A container of crab meat containing crab meat picked from a crab other than a “blue crab” (C. sapidus) is marked with the common name and scientific name of the crab picked into the container;</text> </paragraph> <paragraph num="L."> <text>False or misleading information is not placed on a container of crab meat; and</text> </paragraph> <paragraph num="M."> <text>A container of repacked crab meat is marked:</text> <paragraph num="(1)"> <text>With the date of the repack, which may be a code date;</text> </paragraph> <paragraph num="(2)"> <text>With the crab meat plant numbers of both the original packer and repacker; and</text> </paragraph> <paragraph num="(3)"> <text>To allow the crab meat to be traced back to both the repacker and original packer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Bacteriological Standards."> <paragraph num="A."> <text>The person-in-charge:</text> <paragraph num="(1)"> <text>Shall ensure that crab meat is processed to meet the bacteriological standards set forth in this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>May not distribute crab meat that does not meet these standards.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To establish whether compliance is met with the bacteriological standards for crab meat set forth in §§C and D of this regulation, a person shall utilize the isolation, identification, and enumeration methods that are approved by the Secretary based on the ability of the methods to provide accurate and repeatable results.</text> </paragraph> <paragraph num="C."> <text>The bacteriological standards for crab meat that is not pasteurized are the following:</text> <paragraph num="(1)"> <text>Generic Escherichia coli may not exceed a Most Probable Number of 3.6 per gram of fresh crabmeat;</text> </paragraph> <paragraph num="(2)"> <text>Listeria monocytogenes and enterohemorrhagic Escherichia coli may not be present in fresh crab meat; and</text> </paragraph> <paragraph num="(3)"> <text>Standard Plate Count may not exceed 100,000 colony-forming units per gram of crab meat.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The bacteriological standards for pasteurized crab meat are the following:</text> <paragraph num="(1)"> <text>Escherichia coli may not be present in pasteurized crab meat;</text> </paragraph> <paragraph num="(2)"> <text>Listeria monocytogenes may not be present in pasteurized crab meat; and</text> </paragraph> <paragraph num="(3)"> <text>Standard Plate Count may not exceed 25,000 colony-forming units per gram of crab meat.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-339, 21-340, and 21-350, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 15, 1955</annotation> <annotation type="History" subtype="Administrative History">Amended effective September 3, 1957</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended effective September 14, 1977 (4:19 Md. R. 1468)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended and .05-1 adopted effective September 30, 1994 (21:9 Md. R. 751)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed and new Regulations .01—.15 adopted effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C—E amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11H, J amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B, D amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B, C amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15C amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15E repealed effective February 15, 2016 (43:3 Md. R. 272)</annotation> </annotations> </chapter> <chapter num="03" heading="Food Service Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Governs food service facilities in Maryland;</text> </paragraph> <paragraph num="B."> <text>Along with COMAR 10.15.04, 15.04.01, and 15.11.11, establishes the standards for the control of Salmonella Enteritidis in shell eggs and egg-producing chickens as part of a program jointly administered by the Maryland Department of Health and the Maryland Department of Agriculture; and</text> </paragraph> <paragraph num="C."> <text>Is not intended to govern the food service operations in a child care center as defined in Family Law Article, §5-570, Annotated Code of Maryland, or a family day care home as defined in Family Law Article, §5-501, Annotated Code of Maryland, unless the food service operation is conducted in conjunction with another institution that is governed by this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acceptable” means agreeable to the use or presence of equipment or a practice when standards are not developed or when developed standards are inappropriate, because the approving authority has determined that the equipment or practice conforms to principles, practices, and generally recognized standards that protect public health.</text> </paragraph> <paragraph num="(2)"> <text>Adulterated.</text> <paragraph num="(a)"> <text>“Adulterated” has the meaning stated in Health-General Article, §§21-207, 21-208, and 21-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Adulterated” includes food that:</text> <paragraph num="(i)"> <text>Contains any poisonous or deleterious substance;</text> </paragraph> <paragraph num="(ii)"> <text>Is diseased, contaminated, filthy, putrid, or decomposed; or</text> </paragraph> <paragraph num="(iii)"> <text>Is otherwise unfit as food for human beings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source:</text> <paragraph num="(a)"> <text>Are not adulterated or misbranded; and</text> </paragraph> <paragraph num="(b)"> <text>Where required, are regulated by the approving authority.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Approving authority” means:</text> <paragraph num="(a)"> <text>Within the State, the Secretary of Health or the Secretary's designee; or</text> </paragraph> <paragraph num="(b)"> <text>Outside the State, the agency designated in the laws of another state or country to license or permit a food establishment.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“aw” means water activity, which is:</text> <paragraph num="(a)"> <text>The ratio of the water vapor pressure of a food to the vapor pressure of pure water at the same temperature; and</text> </paragraph> <paragraph num="(b)"> <text>An index of the available, free moisture in food.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Bake Sale.</text> <paragraph num="(a)"> <text>“Bake sale” means a place where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event.</text> </paragraph> <paragraph num="(b)"> <text>“Bake sale” does not include a place:</text> <paragraph num="(i)"> <text>Where a person sells baked goods for individual profit;</text> </paragraph> <paragraph num="(ii)"> <text>From which food is commercially distributed; or</text> </paragraph> <paragraph num="(iii)"> <text>Where a potentially hazardous baked good is sold or distributed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Barrier” means a physical, biological, or chemical factor that retards or prevents the growth of microorganisms that are infectious or toxigenic.</text> </paragraph> <paragraph num="(7-1)"> <text>“Base of operations” means a licensed food service facility that is used by the owner or operator of a mobile food service facility for food storage, potable water, safe disposal of waste and sewage, and, if necessary, utensil washing.</text> </paragraph> <paragraph num="(8)"> <text>“Bed and breakfast” means a lodging or rooming house as defined in Public Safety Article, §9-201, Annotated Code of Maryland, that has eight rooms or fewer for rent.</text> </paragraph> <paragraph num="(9)"> <text>“Bona fide nonprofit” means an organization having official documentation from the United States Internal Revenue Service that the organization has current tax-exempt nonprofit status.</text> </paragraph> <paragraph num="(10)"> <text>“Caterer” means a food service facility that:</text> <paragraph num="(a)"> <text>Offers catering services; or</text> </paragraph> <paragraph num="(b)"> <text>Identifies itself as a caterer.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Catering services” means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a:</text> <paragraph num="(a)"> <text>Specific public event; or</text> </paragraph> <paragraph num="(b)"> <text>Business or social function or affair.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Commercially sterile” means the condition achieved by the:</text> <paragraph num="(a)"> <text>Application of heat, pressure, or other energy or matter that renders a food free of:</text> <paragraph num="(i)"> <text>Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and</text> </paragraph> <paragraph num="(ii)"> <text>Viable microorganisms, including spores, that may cause disease; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Control of water activity and the application of heat, pressure, or other energy or matter that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Comminuted.</text> <paragraph num="(a)"> <text>“Comminuted” means reduced in size by methods including:</text> <paragraph num="(i)"> <text>Chopping;</text> </paragraph> <paragraph num="(ii)"> <text>Flaking;</text> </paragraph> <paragraph num="(iii)"> <text>Grinding; or</text> </paragraph> <paragraph num="(iv)"> <text>Mincing.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Comminuted” includes fish, meat, or a mixture of products that are reduced in size and restructured or reformulated, such as:</text> <paragraph num="(i)"> <text>Gefilte fish;</text> </paragraph> <paragraph num="(ii)"> <text>Formed roast beef;</text> </paragraph> <paragraph num="(iii)"> <text>The meat used in gyros;</text> </paragraph> <paragraph num="(iv)"> <text>Ground beef; and</text> </paragraph> <paragraph num="(v)"> <text>Sausage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Condiment” means a food or seasoning used to enhance the flavor of another food, including:</text> <paragraph num="(a)"> <text>Mustard;</text> </paragraph> <paragraph num="(b)"> <text>Ketchup;</text> </paragraph> <paragraph num="(c)"> <text>Mayonnaise;</text> </paragraph> <paragraph num="(d)"> <text>Relish;</text> </paragraph> <paragraph num="(e)"> <text>Salt;</text> </paragraph> <paragraph num="(f)"> <text>Pepper;</text> </paragraph> <paragraph num="(g)"> <text>Sugar; or</text> </paragraph> <paragraph num="(h)"> <text>Chutney.</text> </paragraph> </paragraph> <paragraph num="(14-1)"> <text>“Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food service facility or food processing plant, and does not offer the food for resale.</text> </paragraph> <paragraph num="(15)"> <text>“Consumer advisory” means a written notification to consumers that:</text> <paragraph num="(a)"> <text>Identifies food of animal origin that is served or sold as a ready-to-eat food or as an ingredient in a ready-to-eat food that is:</text> <paragraph num="(i)"> <text>Raw;</text> </paragraph> <paragraph num="(ii)"> <text>Undercooked; or</text> </paragraph> <paragraph num="(iii)"> <text>Not otherwise processed to eliminate pathogens; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Reminds consumers that consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase the risk of foodborne illness, especially if the consumer has certain medical conditions.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Continental Breakfast.</text> <paragraph num="(a)"> <text>“Continental breakfast” means a meal that does not require major food preparation as specified in Regulation .28G(1) of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Continental breakfast” includes foods such as:</text> <paragraph num="(i)"> <text>Coffee and tea;</text> </paragraph> <paragraph num="(ii)"> <text>Juice;</text> </paragraph> <paragraph num="(iii)"> <text>Cereal;</text> </paragraph> <paragraph num="(iv)"> <text>Milk and cream;</text> </paragraph> <paragraph num="(v)"> <text>Whole fresh fruit;</text> </paragraph> <paragraph num="(vi)"> <text>Pastries;</text> </paragraph> <paragraph num="(vii)"> <text>Bread;</text> </paragraph> <paragraph num="(viii)"> <text>Donuts;</text> </paragraph> <paragraph num="(ix)"> <text>Butter and margarine; and</text> </paragraph> <paragraph num="(x)"> <text>Jams and jellies.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Continental breakfast” does not include foods such as:</text> <paragraph num="(i)"> <text>Eggs cooked outside of the shell;</text> </paragraph> <paragraph num="(ii)"> <text>Meat; and</text> </paragraph> <paragraph num="(iii)"> <text>Fruit salad prepared on premises.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Corrosion resistant” means the property that allows a material to maintain sanitary surface characteristics under the influence of prolonged contact with:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Cleaning compounds;</text> </paragraph> <paragraph num="(c)"> <text>Sanitizing solutions; and</text> </paragraph> <paragraph num="(d)"> <text>Other conditions of the environment.</text> </paragraph> </paragraph> <paragraph num="(17-1)"> <text>“Cottage food business” means a business that:</text> <paragraph num="(a)"> <text>Produces or packages cottage food products in a residential kitchen in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Has annual revenues from the sale of cottage food products in an amount not exceeding $50,000.</text> </paragraph> </paragraph> <paragraph num="(17-2)"> <text>“Cottage food product” means:</text> <paragraph num="(a)"> <text>A non-potentially hazardous food as specified in Regulation .27 of this chapter that is offered for sale:</text> <paragraph num="(i)"> <text>Directly to a consumer from a residence, by personal delivery, by mail delivery, at a farmer’s market, or at a public event; or</text> </paragraph> <paragraph num="(ii)"> <text>To a retail food store if the cottage food product remains in the original packaging; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A food that is not offered for sale through interstate commerce.</text> </paragraph> </paragraph> <paragraph num="(17-3)"> <text>“County of origin” means the county in which the base of operations of a mobile food service facility is located.</text> </paragraph> <paragraph num="(18)"> <text>“Critical control point (CCP)” means a point in the preparation or processing of food where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health.</text> </paragraph> <paragraph num="(19)"> <text>Critical Item.</text> <paragraph num="(a)"> <text>“Critical item” means a food safety requirement that if violated requires:</text> <paragraph num="(i)"> <text>Immediate correction;</text> </paragraph> <paragraph num="(ii)"> <text>The cessation of some or all processing operations; or</text> </paragraph> <paragraph num="(iii)"> <text>Plant closure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Critical item” includes the following requirements:</text> <paragraph num="(i)"> <text>Obtaining food from an approved source;</text> </paragraph> <paragraph num="(ii)"> <text>Protecting food from adulteration, spoilage, and contamination;</text> </paragraph> <paragraph num="(iii)"> <text>Restricting food workers with infection or diarrhea in accordance with COMAR 10.06.01;</text> </paragraph> <paragraph num="(iv)"> <text>Ensuring that all food workers wash hands thoroughly before touching food and utensils, and as often as needed to prevent food contamination from hand contact;</text> </paragraph> <paragraph num="(v)"> <text>Cooling potentially hazardous foods in accordance with the requirements of this chapter;</text> </paragraph> <paragraph num="(vi)"> <text>Holding potentially hazardous foods at the hot and cold temperatures specified in this chapter;</text> </paragraph> <paragraph num="(vii)"> <text>Cooking and reheating potentially hazardous foods in accordance with the requirements of this chapter;</text> </paragraph> <paragraph num="(viii)"> <text>Providing potable hot and cold running water; and</text> </paragraph> <paragraph num="(ix)"> <text>Discharging sewage from the facility in accordance with all applicable State and local codes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Critical limit” means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that an identified potential food safety hazard may occur.</text> </paragraph> <paragraph num="(21)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(22)"> <text>“Detention order” means a written notification by the approving authority to the person-in-charge of a food service facility to detain food that may be adulterated or misbranded, pending a determination of the food's status and disposition in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Easily cleanable” means the property of a surface that allows the surface to:</text> <paragraph num="(a)"> <text>Be readily accessible; and</text> </paragraph> <paragraph num="(b)"> <text>Have soil and residue removed by routine cleaning methods.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Egg carton” means a container holding up to 36 shell eggs, including overwrapped cartons and sleeves, that is used to pack shell eggs for distribution or sale to a consumer.</text> </paragraph> <paragraph num="(25)"> <text>“Egg case” means a container that:</text> <paragraph num="(a)"> <text>Is not a carton;</text> </paragraph> <paragraph num="(b)"> <text>Holds either loose shell eggs or cartons of eggs; and</text> </paragraph> <paragraph num="(c)"> <text>Is used to pack shell eggs for distribution or sale to a consumer.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Employee” means:</text> <paragraph num="(a)"> <text>The licensee;</text> </paragraph> <paragraph num="(b)"> <text>An individual having supervisory or management duties;</text> </paragraph> <paragraph num="(c)"> <text>An individual on the payroll;</text> </paragraph> <paragraph num="(d)"> <text>A volunteer;</text> </paragraph> <paragraph num="(e)"> <text>An individual performing work under contractual agreement; or</text> </paragraph> <paragraph num="(f)"> <text>Any other individual working in a food service facility.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>Equipment.</text> <paragraph num="(a)"> <text>“Equipment” means an item, other than a utensil, that is used in the operation of a food establishment for:</text> <paragraph num="(i)"> <text>Storage;</text> </paragraph> <paragraph num="(ii)"> <text>Preparation;</text> </paragraph> <paragraph num="(iii)"> <text>Display;</text> </paragraph> <paragraph num="(iv)"> <text>Washing; or</text> </paragraph> <paragraph num="(v)"> <text>Transportation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Equipment” includes a:</text> <paragraph num="(i)"> <text>Stove;</text> </paragraph> <paragraph num="(ii)"> <text>Oven;</text> </paragraph> <paragraph num="(iii)"> <text>Hood;</text> </paragraph> <paragraph num="(iv)"> <text>Slicer;</text> </paragraph> <paragraph num="(v)"> <text>Grinder;</text> </paragraph> <paragraph num="(vi)"> <text>Mixer;</text> </paragraph> <paragraph num="(vii)"> <text>Scale;</text> </paragraph> <paragraph num="(viii)"> <text>Meat block;</text> </paragraph> <paragraph num="(ix)"> <text>Table;</text> </paragraph> <paragraph num="(x)"> <text>Food shelf;</text> </paragraph> <paragraph num="(xi)"> <text>Refrigerator;</text> </paragraph> <paragraph num="(xii)"> <text>Freezer;</text> </paragraph> <paragraph num="(xiii)"> <text>Sink;</text> </paragraph> <paragraph num="(xiv)"> <text>Ice maker; or</text> </paragraph> <paragraph num="(xv)"> <text>Another item used in the operation of a food service facility.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Equipment” does not include a:</text> <paragraph num="(i)"> <text>Forklift truck; or</text> </paragraph> <paragraph num="(ii)"> <text>Dolly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Excluded organization” means a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days.</text> </paragraph> <paragraph num="(29)"> <text>Farm.</text> <paragraph num="(a)"> <text>“Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes.</text> </paragraph> <paragraph num="(b)"> <text>“Farm” includes a place where, for commercial purposes:</text> <paragraph num="(i)"> <text>Crops are grown and harvested;</text> </paragraph> <paragraph num="(ii)"> <text>Fruit, nuts, or other agricultural commodities are harvested from trees; or</text> </paragraph> <paragraph num="(iii)"> <text>Animals are raised, fed, and managed for meat or other agricultural commodities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>Farmer's Market.</text> <paragraph num="(a)"> <text>“Farmer's market” means a place where a person offers or sells one or more of the following food products directly to the public:</text> <paragraph num="(i)"> <text>Raw agricultural products;</text> </paragraph> <paragraph num="(ii)"> <text>Products processed in a private home kitchen, as set forth in Regulation .27 of this chapter;</text> </paragraph> <paragraph num="(iii)"> <text>Products that are not potentially hazardous and do not require refrigeration that are processed in a food processing plant licensed and operated according to COMAR 10.15.04.19; or</text> </paragraph> <paragraph num="(iv)"> <text>Eggs in compliance with Regulation .05A(8) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Farmer's market” does not include a food service facility.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Food” means:</text> <paragraph num="(a)"> <text>A substance that is used as:</text> <paragraph num="(i)"> <text>Food or drink for human beings; or</text> </paragraph> <paragraph num="(ii)"> <text>A component of food or drink for human beings; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Chewing gum or any substance that is a component of chewing gum.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Food-contact surface” means a surface:</text> <paragraph num="(a)"> <text>Of equipment and utensils with which food normally comes in contact; or</text> </paragraph> <paragraph num="(b)"> <text>From which food may drain, drip, or splash onto a:</text> <paragraph num="(i)"> <text>Food; or</text> </paragraph> <paragraph num="(ii)"> <text>Surface normally in contact with food.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Food processing plant” has the meaning stated in COMAR 10.15.04.02B.</text> </paragraph> <paragraph num="(34)"> <text>Food Service Facility.</text> <paragraph num="(a)"> <text>“Food service facility” means:</text> <paragraph num="(i)"> <text>A place where food or drink is prepared for sale or service on the premises or elsewhere; or</text> </paragraph> <paragraph num="(ii)"> <text>An operation where food is served to or provided for the public with or without charge.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Food service facility” includes:</text> <paragraph num="(i)"> <text>A restaurant, coffee shop, cafeteria, short order cafe, luncheonette, tavern, sandwich stand, soda fountain, retail market, or retail bakery outlet;</text> </paragraph> <paragraph num="(ii)"> <text>A food operation in an industry, institution, health care facility, club, school, camp, church, catering kitchen, commissary, or a similar place in which food or drink is prepared for sale or for service on the premises or elsewhere; and</text> </paragraph> <paragraph num="(iii)"> <text>A micro market licensed under Business Regulation Article, Title 17, Subtitle 17, Annotated Code of Maryland, and meeting the requirements of this chapter as a food service facility.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Food service facility” does not include a:</text> <paragraph num="(i)"> <text>Facility that offers only prepackaged foods that are not potentially hazardous as specified in §B(55)(c) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering that is not a public event, or for service to unemployed, homeless, or another disadvantaged population;</text> </paragraph> <paragraph num="(iii)"> <text>Food preparation or serving area where food is prepared or served only by an excluded organization;</text> </paragraph> <paragraph num="(iv)"> <text>Hotel, lodging, or rooming house that serves only a continental breakfast;</text> </paragraph> <paragraph num="(v)"> <text>Farmer’s market or a public event where food products as specified in §B(30)(a) of this regulation are sold;</text> </paragraph> <paragraph num="(vi)"> <text>Bake sale where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event; or</text> </paragraph> <paragraph num="(vii)"> <text>Cottage food business.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(35)"> <text>Game Animal.</text> <paragraph num="(a)"> <text>“Game animal” means an animal:</text> <paragraph num="(i)"> <text>That is food for human beings; and</text> </paragraph> <paragraph num="(ii)"> <text>That is not classified as cattle, sheep, swine, goat, mule, or other equine.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Game animal” includes:</text> <paragraph num="(i)"> <text>Reindeer;</text> </paragraph> <paragraph num="(ii)"> <text>Elk;</text> </paragraph> <paragraph num="(iii)"> <text>Deer;</text> </paragraph> <paragraph num="(iv)"> <text>Antelope;</text> </paragraph> <paragraph num="(v)"> <text>Water buffalo;</text> </paragraph> <paragraph num="(vi)"> <text>Bison;</text> </paragraph> <paragraph num="(vii)"> <text>Rabbit;</text> </paragraph> <paragraph num="(viii)"> <text>Squirrel;</text> </paragraph> <paragraph num="(ix)"> <text>Opossum;</text> </paragraph> <paragraph num="(x)"> <text>Raccoon;</text> </paragraph> <paragraph num="(xi)"> <text>Nutria;</text> </paragraph> <paragraph num="(xii)"> <text>Muskrat;</text> </paragraph> <paragraph num="(xiii)"> <text>Bear; and</text> </paragraph> <paragraph num="(xiv)"> <text>Nonaquatic reptiles such as land snakes.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Game animal” does not include ratites such as:</text> <paragraph num="(i)"> <text>Ostrich;</text> </paragraph> <paragraph num="(ii)"> <text>Emu; and</text> </paragraph> <paragraph num="(iii)"> <text>Rhea.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Hazard” means a biological, chemical, or physical property that may be detrimental to public health.</text> </paragraph> <paragraph num="(37)"> <text>“Hazard analysis critical control point (HACCP) plan” means a written plan that delineates the procedures for maintaining control of potentially hazardous food at the critical control points of food preparation or processing.</text> </paragraph> <paragraph num="(38)"> <text>Health Care Facility.</text> <paragraph num="(a)"> <text>“Health care facility” means:</text> <paragraph num="(i)"> <text>A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>An ambulatory surgical facility or center as defined in Health-General Article, §19-114, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision;</text> </paragraph> <paragraph num="(v)"> <text>A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>A hospice facility, as defined in Health-General Article, §19-901, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(vii)"> <text>Another health institution, service, or program for which Health-General Article, §19-114(d)(1)(ix), Annotated Code of Maryland, requires a certificate of need.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care facility” does not include the facilities, institutions, and offices set forth in Health-General Article, §19-114(d)(2), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Hermetically sealed container” means a container that:</text> <paragraph num="(a)"> <text>Is secure against the entry of microorganisms; and</text> </paragraph> <paragraph num="(b)"> <text>Maintains the commercial sterility of the contents after processing.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>“Juice” means:</text> <paragraph num="(a)"> <text>The aqueous liquid expressed or extracted from one or more fruits or vegetables;</text> </paragraph> <paragraph num="(b)"> <text>Purees of the edible portion of one or more fruits or vegetables; or</text> </paragraph> <paragraph num="(c)"> <text>Any concentrate of the liquid or puree as referenced in §B(40)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(41)"> <text>“License” means the authority to operate a food service facility within the State in accordance with this chapter and Health-General Article, Title 21, Subtitles 1, 2, and 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(42)"> <text>“Loose eggs” means shell eggs not contained in a carton.</text> </paragraph> <paragraph num="(43)"> <text>“Lot designation” means a method of marking packed or packaged shell eggs to enable the packer and the approving authority to trace the eggs to the flock that produced the eggs.</text> </paragraph> <paragraph num="(44)"> <text>Major Food Allergen.</text> <paragraph num="(a)"> <text>“Major food allergen” means:</text> <paragraph num="(i)"> <text>Milk;</text> </paragraph> <paragraph num="(ii)"> <text>Egg;</text> </paragraph> <paragraph num="(iii)"> <text>Fish such as bass, flounder, or cod;</text> </paragraph> <paragraph num="(iv)"> <text>Crustacea such as crab, lobster, or shrimp;</text> </paragraph> <paragraph num="(v)"> <text>Tree nuts such as almonds, pecans, or walnuts;</text> </paragraph> <paragraph num="(vi)"> <text>Wheat;</text> </paragraph> <paragraph num="(vii)"> <text>Peanuts;</text> </paragraph> <paragraph num="(viii)"> <text>Soybeans; and</text> </paragraph> <paragraph num="(ix)"> <text>A food ingredient that contains protein derived from milk, egg, fish, tree nuts, wheat, peanuts, or soybeans.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Major food allergen” does not include:</text> <paragraph num="(i)"> <text>A highly refined oil derived from a food specified in §B(44)(a) of this regulation and any ingredient derived from a highly refined oil; or</text> </paragraph> <paragraph num="(ii)"> <text>An ingredient that is exempt in regard to food allergen labeling requirements under the petition or notification process specified in 21 U.S.C. §343(w)(6) and (7).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(44-1)"> <text>“Micro market” means an unstaffed, self-checkout retail food service facility that:</text> <paragraph num="(a)"> <text>Includes one or more micro market displays;</text> </paragraph> <paragraph num="(b)"> <text>Has an automated payment kiosk or other device designed to accept electronic payments that is operated by the consumer;</text> </paragraph> <paragraph num="(c)"> <text>Is located indoors and within a separate business; and</text> </paragraph> <paragraph num="(d)"> <text>Is generally accessible only to individuals within the building in which the food service facility is located.</text> </paragraph> </paragraph> <paragraph num="(44-2)"> <text>“Micro market display” means the place where the food being sold by a micro market is displayed, including:</text> <paragraph num="(a)"> <text>An open rack;</text> </paragraph> <paragraph num="(b)"> <text>A refrigerator or a refrigerated cooler;</text> </paragraph> <paragraph num="(c)"> <text>A freezer;</text> </paragraph> <paragraph num="(d)"> <text>A vending machine;</text> </paragraph> <paragraph num="(e)"> <text>A beverage dispenser; or</text> </paragraph> <paragraph num="(f)"> <text>A single-serve coffee brewer.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(46)"> <text>Mobile Food Service Facility.</text> <paragraph num="(a)"> <text>“Mobile food service facility” means a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to:</text> <paragraph num="(i)"> <text>Change location for sales;</text> </paragraph> <paragraph num="(ii)"> <text>Obtain food and other supplies;</text> </paragraph> <paragraph num="(iii)"> <text>Fill potable water supply holding tanks;</text> </paragraph> <paragraph num="(iv)"> <text>Empty wastewater holding tanks; or</text> </paragraph> <paragraph num="(v)"> <text>Provide for the cleaning and sanitization of equipment and utensils.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Mobile food service facility” does not include a food service facility that is able to be moved but does not move routinely for a purpose set forth in §B(46)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(46-1)"> <text>“Mobile reciprocity license” means a license issued to a mobile food service facility that:</text> <paragraph num="(a)"> <text>Is operating in the jurisdiction;</text> </paragraph> <paragraph num="(b)"> <text>Is operating within 90 miles of its base of operations; and</text> </paragraph> <paragraph num="(c)"> <text>Holds a valid license from the county of origin.</text> </paragraph> </paragraph> <paragraph num="(47)"> <text>“Non-potentially hazardous food” means food named or described in §B(55)(c) of this regulation.</text> </paragraph> <paragraph num="(48)"> <text>“On-farm food service facility” means a temporary food service facility that:</text> <paragraph num="(a)"> <text>Is located on a farm;</text> </paragraph> <paragraph num="(b)"> <text>Serves only those foods approved by the Department, based on a:</text> <paragraph num="(i)"> <text>Review of the facility, equipment, and processing hazards; and</text> </paragraph> <paragraph num="(ii)"> <text>Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“Package” means a bottle, can, carton, bag, or wrapped container.</text> </paragraph> <paragraph num="(50)"> <text>“Packer” means a person who places shell eggs in the original case, carton, or container that is used to hold eggs for:</text> <paragraph num="(a)"> <text>Distribution; or</text> </paragraph> <paragraph num="(b)"> <text>Sale to a consumer.</text> </paragraph> </paragraph> <paragraph num="(51)"> <text>“Person” has the meaning stated in Health-General Article, §§1-101 and 21-101, including:</text> <paragraph num="(a)"> <text>An operator of a facility that is owned by the State or local unit of government; or</text> </paragraph> <paragraph num="(b)"> <text>A State or local unit of government if the State or local unit of government is the operator of the facility.</text> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Person-in-charge” means:</text> <paragraph num="(a)"> <text>The licensee; or</text> </paragraph> <paragraph num="(b)"> <text>Another person responsible for the operation of a food service facility.</text> </paragraph> </paragraph> <paragraph num="(53)"> <text>“pH” means the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where:</text> <paragraph num="(a)"> <text>pH values from 0 to 7 indicate acidity;</text> </paragraph> <paragraph num="(b)"> <text>pH values from 7 to14 indicate alkalinity; and</text> </paragraph> <paragraph num="(c)"> <text>The pH value for pure distilled water, regarded as neutral, is 7.</text> </paragraph> </paragraph> <paragraph num="(54)"> <text>“Portable” means that equipment:</text> <paragraph num="(a)"> <text>Can be easily moved because the equipment is:</text> <paragraph num="(i)"> <text>Small in size and weighs 80 pounds or less;</text> </paragraph> <paragraph num="(ii)"> <text>Mounted on casters, gliders, or rollers; or</text> </paragraph> <paragraph num="(iii)"> <text>Provided with a mechanical means of safely tilting for cleaning; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has one of the following:</text> <paragraph num="(i)"> <text>No utility connection;</text> </paragraph> <paragraph num="(ii)"> <text>A utility connection that disconnects quickly; or</text> </paragraph> <paragraph num="(iii)"> <text>A flexible utility connection line long enough to permit the equipment to be moved for thorough cleaning.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(55)"> <text>Potentially Hazardous Food.</text> <paragraph num="(a)"> <text>“Potentially hazardous food” means a natural or synthetic food that requires temperature control because the food is in a form capable of supporting:</text> <paragraph num="(i)"> <text>The rapid and progressive growth of infectious or toxigenic microorganisms;</text> </paragraph> <paragraph num="(ii)"> <text>The growth and toxin production of Clostridium botulinum; or</text> </paragraph> <paragraph num="(iii)"> <text>In raw shell eggs, the growth of Salmonella Enteritidis.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Potentially hazardous food” includes:</text> <paragraph num="(i)"> <text>A food of animal origin that is raw or heat-treated;</text> </paragraph> <paragraph num="(ii)"> <text>A food of plant origin that is heat-treated;</text> </paragraph> <paragraph num="(iii)"> <text>Raw seed sprouts;</text> </paragraph> <paragraph num="(iv)"> <text>Cut melons;</text> </paragraph> <paragraph num="(v)"> <text>Cut raw tomatoes;</text> </paragraph> <paragraph num="(vi)"> <text>Garlic and oil mixtures that support growth as specified in §B(55)(a)(i) and (ii) of this regulation; and</text> </paragraph> <paragraph num="(vii)"> <text>Cut leafy greens.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Potentially hazardous food” does not include a:</text> <paragraph num="(i)"> <text>Hard-boiled shell egg that has been air-cooled with the shell intact;</text> </paragraph> <paragraph num="(ii)"> <text>Food with an aw value of 0.85 or less;</text> </paragraph> <paragraph num="(iii)"> <text>Food with a pH level of 4.6 or below when measured at 75°F;</text> </paragraph> <paragraph num="(iv)"> <text>Commercially sterile food in a hermetically sealed container; or</text> </paragraph> <paragraph num="(v)"> <text>Food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious and toxigenic microorganisms or the growth of Salmonella Enteritidis in eggs or Clostridium botulinum cannot occur, such as a food that has an aw or a pH that is above the levels specified in §B(55)(c)(ii)and(iii) of this regulation or that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(56)"> <text>“Poultry” means a:</text> <paragraph num="(a)"> <text>Domesticated bird whether live or dead including a:</text> <paragraph num="(i)"> <text>Chicken;</text> </paragraph> <paragraph num="(ii)"> <text>Turkey;</text> </paragraph> <paragraph num="(iii)"> <text>Duck;</text> </paragraph> <paragraph num="(iv)"> <text>Goose;</text> </paragraph> <paragraph num="(v)"> <text>Guinea;</text> </paragraph> <paragraph num="(vi)"> <text>Ratite; or</text> </paragraph> <paragraph num="(vii)"> <text>Squab; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Migratory waterfowl or game bird whether live or dead, including a:</text> <paragraph num="(i)"> <text>Pheasant;</text> </paragraph> <paragraph num="(ii)"> <text>Partridge;</text> </paragraph> <paragraph num="(iii)"> <text>Quail; or</text> </paragraph> <paragraph num="(iv)"> <text>Grouse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(57)"> <text>“Premises” means the physical food service facility and the contiguous land or property under the control of the operator or the licensee.</text> </paragraph> <paragraph num="(58)"> <text>“Principal display panel” means the part of a container that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.</text> </paragraph> <paragraph num="(59)"> <text>“Priority assessment” means an evaluation of risk in a food service facility using the parameters established by the Department in Regulation .33C of this chapter.</text> </paragraph> <paragraph num="(60)"> <text>Public Event.</text> <paragraph num="(a)"> <text>“Public event” means an event or festival that is a planned gathering that is:</text> <paragraph num="(i)"> <text>Open to the public; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulated by the State or local jurisdiction in which the planned gathering takes place.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Public event” includes an event or festival:</text> <paragraph num="(i)"> <text>Attended by individuals from the general public whether or not a fee is charged; or</text> </paragraph> <paragraph num="(ii)"> <text>Advertised with fliers, banners, newspaper articles, radio or television announcements, or on an Internet website as being open to the public.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Public event” does not include a:</text> <paragraph num="(i)"> <text>Private party;</text> </paragraph> <paragraph num="(ii)"> <text>An event restricted to organization members; or</text> </paragraph> <paragraph num="(iii)"> <text>Another event that restricts the general public from attending.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(61)"> <text>“Raw agricultural product” means a whole, unprocessed agricultural product supplied directly from the farm on which it was produced, including:</text> <paragraph num="(a)"> <text>Grains;</text> </paragraph> <paragraph num="(b)"> <text>Flowers;</text> </paragraph> <paragraph num="(c)"> <text>Herbs;</text> </paragraph> <paragraph num="(d)"> <text>Nuts;</text> </paragraph> <paragraph num="(e)"> <text>Fruits;</text> </paragraph> <paragraph num="(f)"> <text>Vegetables; and</text> </paragraph> <paragraph num="(g)"> <text>Honey.</text> </paragraph> </paragraph> <paragraph num="(62)"> <text>Ready-to-Eat Food.</text> <paragraph num="(a)"> <text>“Ready-to-eat food” means food in a form that is edible without washing, cooking, or additional preparation by the food service facility or the consumer.</text> </paragraph> <paragraph num="(b)"> <text>“Ready-to-eat food” includes:</text> <paragraph num="(i)"> <text>Potentially hazardous food that is cooked to the temperature and time required for a specific food as set forth in Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Raw fruits and vegetables that are washed and cut;</text> </paragraph> <paragraph num="(iii)"> <text>Whole, raw fruits and vegetables that are presented for consumption without need for further washing, such as at a buffet; and</text> </paragraph> <paragraph num="(iv)"> <text>A food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(62-1)"> <text>“Reconditioned” means reprocessing a food using an approved method that results in a food that is safe, wholesome, and free from contamination.</text> </paragraph> <paragraph num="(63)"> <text>“Reconstituted” means water or other liquid has been restored to a food that was previously dehydrated.</text> </paragraph> <paragraph num="(64)"> <text>Reduced Oxygen Packaged.</text> <paragraph num="(a)"> <text>“Reduced oxygen packaged” means that a food was packaged so that the amount of oxygen in the package is below that found in the surrounding atmosphere due to the:</text> <paragraph num="(i)"> <text>Mechanical evacuation of oxygen;</text> </paragraph> <paragraph num="(ii)"> <text>Displacement of oxygen with one or more gases; or</text> </paragraph> <paragraph num="(iii)"> <text>Reduction of the oxygen content by other means.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Reduced oxygen packaged” includes food that is:</text> <paragraph num="(i)"> <text>Vacuum packaged;</text> </paragraph> <paragraph num="(ii)"> <text>Modified atmosphere packaged; and</text> </paragraph> <paragraph num="(iii)"> <text>Controlled atmosphere packaged.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(65)"> <text>“Refrigerated food” means a food that:</text> <paragraph num="(a)"> <text>Is not shelf stable;</text> </paragraph> <paragraph num="(b)"> <text>Must be refrigerated to:</text> <paragraph num="(i)"> <text>Retard the growth of spoilage or pathogenic microorganisms; and</text> </paragraph> <paragraph num="(ii)"> <text>Prevent the production of microbial toxins; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is labeled by the manufacturer with a statement indicating that the product is to be kept refrigerated.</text> </paragraph> </paragraph> <paragraph num="(66)"> <text>“Registration” means the process by which the Maryland Department of Agriculture grants the authority to a packer within the State to provide shell eggs for human consumption.</text> </paragraph> <paragraph num="(67)"> <text>“Registration number” means the number that the Maryland Department of Agriculture assigns a packer.</text> </paragraph> <paragraph num="(68)"> <text>“Retail food manufacturing” means the manufacturing of food in a food service facility for wholesale distribution.</text> </paragraph> <paragraph num="(68-1)"> <text>Retail Food Store.</text> <paragraph num="(a)"> <text>“Retail food store” means a licensed food service facility that sells prepackaged food items either fresh, refrigerated, frozen, or shelf-stable.</text> </paragraph> <paragraph num="(b)"> <text>“Retail food store” includes a grocery store, convenience store, retail market, retail bakery, or food cooperative.</text> </paragraph> <paragraph num="(c)"> <text>“Retail food store” does not include a restaurant, mobile food service facility, coffee shop, cafeteria, short order café, luncheonette, tavern sandwich shop, produce stand that only offers whole, uncut fresh fruits and vegetables, or establishment that offers only pre-packaged non-potentially hazardous foods.</text> </paragraph> </paragraph> <paragraph num="(69)"> <text>“Sanitization” means a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance.</text> </paragraph> <paragraph num="(70)"> <text>“Seasonal farmer’s market producer sampling food service facility” means a facility that:</text> <paragraph num="(a)"> <text>Serves only foods that are prepared and offered as samples by a producer of a farm product at a farmer’s market or a public event, such as:</text> <paragraph num="(i)"> <text>Farm products as specified in §B(30)(a) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Serves food only produced by the licensee;</text> </paragraph> <paragraph num="(c)"> <text>Serves only those foods approved by the Department, based on a:</text> <paragraph num="(i)"> <text>Review of the facility, equipment, and processing hazards; and</text> </paragraph> <paragraph num="(ii)"> <text>Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Operates during a period of time of not more than a 1-year period from the date of issuance or renewal of the license.</text> </paragraph> </paragraph> <paragraph num="(71)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(72)"> <text>“Semi-permanent food service facility” means a facility that:</text> <paragraph num="(a)"> <text>Is built at a location other than where it operates;</text> </paragraph> <paragraph num="(b)"> <text>Is transported as a complete unit that does not require a building permit to install on the location at which it operates;</text> </paragraph> <paragraph num="(c)"> <text>Has no indoor seating for patrons;</text> </paragraph> <paragraph num="(d)"> <text>When serving cooked food, serves only foods cooked for immediate service; and</text> </paragraph> <paragraph num="(e)"> <text>Is not a mobile food service facility as specified in §B(46) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(73)"> <text>“Service animal” has the meaning stated in Human Services Article, §7-701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(74)"> <text>“Shell eggs” means raw eggs produced by chickens for human consumption.</text> </paragraph> <paragraph num="(75)"> <text>“Shellfish” means all species of:</text> <paragraph num="(a)"> <text>Oysters, clams, or mussels, whether:</text> <paragraph num="(i)"> <text>Shucked or in the shell;</text> </paragraph> <paragraph num="(ii)"> <text>Raw, including post-harvest processed;</text> </paragraph> <paragraph num="(iii)"> <text>Frozen or unfrozen; and</text> </paragraph> <paragraph num="(iv)"> <text>Whole or in part; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Scallops in any form, except when the final product is the adductor muscle only.</text> </paragraph> </paragraph> <paragraph num="(76)"> <text>Single Service Article.</text> <paragraph num="(a)"> <text>“Single service article” means an article designed, fabricated, and intended for one-time consumer use.</text> </paragraph> <paragraph num="(b)"> <text>“Single service article” includes a:</text> <paragraph num="(i)"> <text>Utensil;</text> </paragraph> <paragraph num="(ii)"> <text>Cup;</text> </paragraph> <paragraph num="(iii)"> <text>Plate;</text> </paragraph> <paragraph num="(iv)"> <text>Stirrer;</text> </paragraph> <paragraph num="(v)"> <text>Napkin;</text> </paragraph> <paragraph num="(vi)"> <text>Straw;</text> </paragraph> <paragraph num="(vii)"> <text>Toothpick;</text> </paragraph> <paragraph num="(viii)"> <text>Food container;</text> </paragraph> <paragraph num="(ix)"> <text>Place mat;</text> </paragraph> <paragraph num="(x)"> <text>Food package; or</text> </paragraph> <paragraph num="(xi)"> <text>Similar item.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(77)"> <text>Single Use Article.</text> <paragraph num="(a)"> <text>“Single use article” means an article intended by the manufacturer for one-time use by the preparer of the food.</text> </paragraph> <paragraph num="(b)"> <text>“Single use article” includes a:</text> <paragraph num="(i)"> <text>Bulk food container;</text> </paragraph> <paragraph num="(ii)"> <text>Utensil;</text> </paragraph> <paragraph num="(iii)"> <text>Formed aluminum pie pan;</text> </paragraph> <paragraph num="(iv)"> <text>Jar;</text> </paragraph> <paragraph num="(v)"> <text>Plastic bucket; or</text> </paragraph> <paragraph num="(vi)"> <text>Similar item.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(78)"> <text>Special Food Service Facility.</text> <paragraph num="(a)"> <text>“Special food service facility” means a food service facility for which the Department provides exceptions to certain regulations because of the nature of one or more of the following:</text> <paragraph num="(i)"> <text>Design and operation of the facility;</text> </paragraph> <paragraph num="(ii)"> <text>Food preparation or service methods; or</text> </paragraph> <paragraph num="(iii)"> <text>Limited length of time that the facility operates in association with special events.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Special food service facility” includes:</text> <paragraph num="(i)"> <text>A bed and breakfast that serves hot meals;</text> </paragraph> <paragraph num="(ii)"> <text>A mobile unit;</text> </paragraph> <paragraph num="(iii)"> <text>A temporary food service facility;</text> </paragraph> <paragraph num="(iv)"> <text>A semi-permanent food service facility;</text> </paragraph> <paragraph num="(v)"> <text>An on-farm food service facility; or</text> </paragraph> <paragraph num="(vi)"> <text>A seasonal farmer’s market producer sampling food service facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(79)"> <text>Tableware.</text> <paragraph num="(a)"> <text>“Tableware” means multi-use eating, drinking, and serving utensils.</text> </paragraph> <paragraph num="(b)"> <text>“Tableware” includes:</text> <paragraph num="(i)"> <text>Knives;</text> </paragraph> <paragraph num="(ii)"> <text>Forks;</text> </paragraph> <paragraph num="(iii)"> <text>Spoons;</text> </paragraph> <paragraph num="(iv)"> <text>Bowls;</text> </paragraph> <paragraph num="(v)"> <text>Cups;</text> </paragraph> <paragraph num="(vi)"> <text>Serving dishes;</text> </paragraph> <paragraph num="(vii)"> <text>Tumblers; and</text> </paragraph> <paragraph num="(viii)"> <text>Plates.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(80)"> <text>“Temporary food service facility” means a food service facility that operates at a fixed location for up to 30 consecutive days in conjunction with a:</text> <paragraph num="(a)"> <text>Fair;</text> </paragraph> <paragraph num="(b)"> <text>Carnival;</text> </paragraph> <paragraph num="(c)"> <text>Public exhibition;</text> </paragraph> <paragraph num="(d)"> <text>Construction project;</text> </paragraph> <paragraph num="(e)"> <text>Recreational facility;</text> </paragraph> <paragraph num="(f)"> <text>Fundraising event; or</text> </paragraph> <paragraph num="(g)"> <text>Similar gathering.</text> </paragraph> </paragraph> <paragraph num="(81)"> <text>“Time-only” means using time instead of time in conjunction with temperature as the sole means of food protection for a potentially hazardous food.</text> </paragraph> <paragraph num="(82)"> <text>“Undercooked” means a potentially hazardous food that is not cooked to the minimum internal temperature and for the specified holding time specified in Regulation .10A of this chapter.</text> </paragraph> <paragraph num="(83)"> <text>“Utensil” means tableware or a food-contact implement used in the storage, preparation, dispensing, or serving of food.</text> </paragraph> <paragraph num="(84)"> <text>“Vending machine” means a self-service device that dispenses either packaged or unpackaged food.</text> </paragraph> <paragraph num="(85)"> <text>“Warewashing” means the cleaning and sanitizing of food-contact surfaces of equipment or utensils.</text> </paragraph> <paragraph num="(86)"> <text>Whole Muscle, Intact Beefsteak.</text> <paragraph num="(a)"> <text>“Whole muscle, intact beefsteak” means a beefsteak cut from whole muscle beef that has not been penetrated in a way that may allow infectious or toxigenic microorganisms to be introduced into the interior of the meat.</text> </paragraph> <paragraph num="(b)"> <text>“Whole-muscle, intact beefsteak” does not include meat that has been:</text> <paragraph num="(i)"> <text>Injected;</text> </paragraph> <paragraph num="(ii)"> <text>Mechanically tenderized;</text> </paragraph> <paragraph num="(iii)"> <text>Reconstructed; or</text> </paragraph> <paragraph num="(iv)"> <text>Scored.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>21 CFR, as amended;</text> </paragraph> <paragraph num="(2)"> <text>9 CFR, as amended; and</text> </paragraph> <paragraph num="(3)"> <text>21 U.S.C. §343, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Food Supplies and Sources: General."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Food served to the public is:</text> <paragraph num="(1)"> <text>Wholesome and free from contamination;</text> </paragraph> <paragraph num="(2)"> <text>Not adulterated;</text> </paragraph> <paragraph num="(3)"> <text>Safe for human consumption;</text> </paragraph> <paragraph num="(4)"> <text>Obtained from an approved source; and</text> </paragraph> <paragraph num="(5)"> <text>If in packaged form, labeled in accordance with:</text> <paragraph num="(a)"> <text>COMAR 10.15.01;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.15.02;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.15.04; and</text> </paragraph> <paragraph num="(d)"> <text>This chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Eggs and egg products comply with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="C."> <text>Milk and milk products are not sold or served unless they are produced, processed, stored, transported, and distributed in accordance with COMAR 10.15.06 and COMAR 10.15.09, including:</text> <paragraph num="(1)"> <text>Fluid milk;</text> </paragraph> <paragraph num="(2)"> <text>Other fluid dairy products;</text> </paragraph> <paragraph num="(3)"> <text>Manufactured milk products; and</text> </paragraph> <paragraph num="(4)"> <text>Reconstituted dry milk or dry milk products used only for:</text> <paragraph num="(a)"> <text>Instant desserts;</text> </paragraph> <paragraph num="(b)"> <text>Whipped products; and</text> </paragraph> <paragraph num="(c)"> <text>Cooking and baking purposes;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Frozen desserts including ice cream, soft frozen desserts, ice milk, sherbets, ices, gelato, and frozen dessert mix are manufactured and sold in accordance with COMAR 10.15.05;</text> </paragraph> <paragraph num="E."> <text>Shellfish:</text> <paragraph num="(1)"> <text>Are obtained from an approved source;</text> </paragraph> <paragraph num="(2)"> <text>Are from a firm listed in the “Interstate Certified Shellfish Shippers List”;</text> </paragraph> <paragraph num="(3)"> <text>Are processed, handled, packed, labeled, and identified in accordance with COMAR 10.15.07;</text> </paragraph> <paragraph num="(4)"> <text>Containers are identified with a tag or label as set forth in COMAR 10.15.07; and</text> </paragraph> <paragraph num="(5)"> <text>Tags are maintained on the premises for 90 calendar days after a container of shellfish is emptied to identify readily the source of the shellfish, by:</text> <paragraph num="(a)"> <text>Recording the date on the tag or label when the last shellfish from the container is sold or served;</text> </paragraph> <paragraph num="(b)"> <text>Using an approved record keeping system that:</text> <paragraph num="(i)"> <text>Keeps the tags or labels in chronological order; and</text> </paragraph> <paragraph num="(ii)"> <text>Preserves source identification if tags or labels are removed from the container; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Ensuring that shellfish from one tagged or labeled container is not mixed with shellfish from another container if the tags or labels are removed from the container.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Crab meat is processed, handled, and packed in accordance with COMAR 10.15.02;</text> </paragraph> <paragraph num="G."> <text>Seafood is processed, handled, and packed in accordance with COMAR 10.15.10;</text> </paragraph> <paragraph num="H."> <text>Meat and poultry have been inspected for wholesomeness by the approving authority; and</text> </paragraph> <paragraph num="I."> <text>Ice is:</text> <paragraph num="(1)"> <text>Made:</text> <paragraph num="(a)"> <text>From a potable water supply;</text> </paragraph> <paragraph num="(b)"> <text>In an ice-making machine that:</text> <paragraph num="(i)"> <text>Meets the standards in Regulation .15 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Is located, installed, operated, and maintained to prevent contamination;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If not manufactured on site, obtained from an approved source;</text> </paragraph> <paragraph num="(3)"> <text>Handled, transported, and stored in a manner that precludes contamination; and</text> </paragraph> <paragraph num="(4)"> <text>Not reused.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eggs and Egg Products."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Only clean, whole Grade A or higher grade eggs with shell intact and without cracks, or pasteurized eggs or egg products, are used;</text> </paragraph> <paragraph num="(2)"> <text>An invoice or other equivalent record is obtained from the supplier for each delivery of shell eggs;</text> </paragraph> <paragraph num="(3)"> <text>The invoice or equivalent record required in §A(2) of this regulation contains the following information written in English:</text> <paragraph num="(a)"> <text>Name and address of the seller and buyer;</text> </paragraph> <paragraph num="(b)"> <text>Date of delivery;</text> </paragraph> <paragraph num="(c)"> <text>Grade and size of eggs delivered; and</text> </paragraph> <paragraph num="(d)"> <text>Quantity of eggs sold in number by grade and size;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When loose eggs are distributed, offered for sale, or sold directly to a consumer in Maryland:</text> <paragraph num="(a)"> <text>A daily record is maintained that shows the lot designation of the shell eggs for each packer;</text> </paragraph> <paragraph num="(b)"> <text>A placard is displayed that:</text> <paragraph num="(i)"> <text>Is legible and printed in block letters not less than 3/8 inch in height;</text> </paragraph> <paragraph num="(ii)"> <text>Is a minimum size of 4-1/4 inches by 6 inches;</text> </paragraph> <paragraph num="(iii)"> <text>Plainly and conspicuously displays the eggs' grade term, size (weight), and lot designation; and</text> </paragraph> <paragraph num="(iv)"> <text>Is placed on or near the eggs; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Egg cartons are labeled in accordance with §A(9), (10), and (12) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>All egg invoices, daily records, or other equivalent records are kept on file for a minimum of 90 days;</text> </paragraph> <paragraph num="(6)"> <text>Upon request, the approving authority is granted access to copy and verify, at any reasonable time, records relating to the sale and purchase of shell eggs;</text> </paragraph> <paragraph num="(7)"> <text>Except as provided in Regulation .10 of this chapter, only pasteurized eggs and egg products are used when serving eggs or foods prepared with eggs that have not been heated adequately to kill Salmonella Enteritidis;</text> </paragraph> <paragraph num="(8)"> <text>All shell eggs accepted for delivery, used, or provided to the consumer are:</text> <paragraph num="(a)"> <text>Produced by flocks that are certified to be in compliance with COMAR 15.11.11;</text> </paragraph> <paragraph num="(b)"> <text>Supplied by a registered packer as provided in COMAR 15.04.01; and</text> </paragraph> <paragraph num="(c)"> <text>Pasteurized or otherwise heat-treated to kill Salmonella Enteriditis if Salmonella Enteriditis is isolated from a flock in Maryland as determined by testing procedures contained in COMAR 15.11.11;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>All egg cartons of shell eggs accepted for delivery, used, or provided to the consumer are labeled on the principal display or information panel with:</text> <paragraph num="(a)"> <text>Legible stamping in permanent ink;</text> </paragraph> <paragraph num="(b)"> <text>The following information at a minimum type size of 1/16 of an inch:</text> <paragraph num="(i)"> <text>The packer's or distributor's name and address;</text> </paragraph> <paragraph num="(ii)"> <text>The packer's registration number;</text> </paragraph> <paragraph num="(iii)"> <text>The lot designation of the eggs; and</text> </paragraph> <paragraph num="(iv)"> <text>A safe handling statement with the words “safe handling instructions” in bold capital letters and the statement “To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” set off in a box by hairlines;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The following information at a minimum type size of 1/4 of an inch:</text> <paragraph num="(i)"> <text>The identity of the product as eggs; and</text> </paragraph> <paragraph num="(ii)"> <text>The word “grade” and the grade term (AA or A) and size (weight) of the eggs; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The net quantity of eggs in weight or numerical count in at least the minimum type size permitted based on the space available for labeling as set forth in §B of this regulation, with the minimum type size measurement determined by:</text> <paragraph num="(i)"> <text>The height of type of printing by measuring the height of the lower case letter “o” or its equivalent when mixed upper and lower case letters are used; or</text> </paragraph> <paragraph num="(ii)"> <text>The height of the upper case letters when only upper case letters are used;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>If the safe handling statement does not appear on the principal display panel or the front information panel, a separate statement that eggs be kept refrigerated is printed on either the principal display panel or the front of the information panel;</text> </paragraph> <paragraph num="(11)"> <text>The same information in at least the same minimum type size that is required on an egg carton is printed on the top of an egg case or any side of an egg case; and</text> </paragraph> <paragraph num="(12)"> <text>The grade term and size (weight) on an egg carton is not abbreviated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Table 1.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Food Protection During Storage, Service, and Transport."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>At all times:</text> <paragraph num="(1)"> <text>Food is:</text> <paragraph num="(a)"> <text>Not adulterated; and</text> </paragraph> <paragraph num="(b)"> <text>Protected from contamination during storage, preparation, display, service, and transportation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The internal temperature of a food is maintained according to the requirements of this chapter to preclude the growth of pathogenic bacteria and other microorganisms that could cause spoilage;</text> </paragraph> <paragraph num="(3)"> <text>Except during necessary periods of preparation and service, a potentially hazardous food is refrigerated or held hot as set forth in §B(7) of this regulation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>When storing and holding food:</text> <paragraph num="(1)"> <text>Facilities used for hot or cold potentially hazardous food are provided a temperature-measuring device that is:</text> <paragraph num="(a)"> <text>Graduated and accurate to plus or minus 2°F;</text> </paragraph> <paragraph num="(b)"> <text>Calibrated annually or more frequently;</text> </paragraph> <paragraph num="(c)"> <text>Located in the:</text> <paragraph num="(i)"> <text>Coldest area of equipment where hot foods are stored; and</text> </paragraph> <paragraph num="(ii)"> <text>Warmest area of equipment where cold foods are stored; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Easily readable;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except for metal beverage containers and cased food packaged in cans, glass, or other waterproof containers stored as provided in §B(3) of this regulation, containers of food are stored:</text> <paragraph num="(a)"> <text>Off the floor;</text> </paragraph> <paragraph num="(b)"> <text>18 inches above the floor or higher if food is exposed;</text> </paragraph> <paragraph num="(c)"> <text>On clean racks, dollies, or other clean surfaces; and</text> </paragraph> <paragraph num="(d)"> <text>In a manner that will protect from splash and other contamination;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When metal beverage containers and cased food in cans, glass, or other waterproof containers are stored on the floor:</text> <paragraph num="(a)"> <text>The floor is maintained in a clean and sanitary condition;</text> </paragraph> <paragraph num="(b)"> <text>The storage:</text> <paragraph num="(i)"> <text>Is temporary such as for floor displays;</text> </paragraph> <paragraph num="(ii)"> <text>Does not interfere with the flow of food or personnel; and</text> </paragraph> <paragraph num="(iii)"> <text>Does not afford harborage for rodents or insects;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>In refrigeration units, the food is placed to permit free circulation of cold air;</text> </paragraph> <paragraph num="(5)"> <text>Except where food packaging prevents the entry of water, packaged food is not stored in contact with water or un-drained ice;</text> </paragraph> <paragraph num="(6)"> <text>Food is not stored in locker rooms, toilet rooms, dressing rooms, garbage rooms, or mechanical rooms;</text> </paragraph> <paragraph num="(7)"> <text>Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is kept at 41°F or less or 135°F or greater;</text> </paragraph> <paragraph num="(8)"> <text>If pasteurized crab meat, the crab meat’s internal temperature is maintained at 41°F or less;</text> </paragraph> <paragraph num="(9)"> <text>If potentially hazardous reduced oxygen packaged products, the reduced oxygen packaged food's internal temperature is maintained at:</text> <paragraph num="(a)"> <text>38°F or less if refrigeration is the only barrier to control the growth of Clostridium botulinum; or</text> </paragraph> <paragraph num="(b)"> <text>At a lower temperature if a lower temperature is specified by the food manufacturer;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>If shell eggs and shellfish, the eggs and shellfish are stored, displayed, and transported under refrigeration at an ambient temperature of 45°F or less;</text> </paragraph> <paragraph num="(11)"> <text>Except for the service of foods such as ice cream and frozen desserts, frozen food is received and stored frozen;</text> </paragraph> <paragraph num="(12)"> <text>If a whole roast cooked and cooled in accordance with Regulations .10 and .11 of this chapter, the roast is held at an internal temperature of 130°F or above; and</text> </paragraph> <paragraph num="(13)"> <text>Using holding temperatures and times other than those specified in this section, the holding temperatures and times are:</text> <paragraph num="(a)"> <text>Scientifically proven to be effective in preventing the growth of foodborne pathogens;</text> </paragraph> <paragraph num="(b)"> <text>Incorporated into an HACCP plan; and</text> </paragraph> <paragraph num="(c)"> <text>Submitted to and approved by the Department based on a review that indicates compliance with §B(13)(a) and (b) of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>While displaying and serving food:</text> <paragraph num="(1)"> <text>Except as provided in §C(3) of this regulation, a potentially hazardous cold food that is placed on display is:</text> <paragraph num="(a)"> <text>Pre-chilled to an internal temperature of 41°F or below;</text> </paragraph> <paragraph num="(b)"> <text>Rapidly re-chilled to an internal temperature of 41ºF or below if the food has exceeded 41ºF for a verifiable period of not more than 4 hours; or</text> </paragraph> <paragraph num="(c)"> <text>Discarded if:</text> <paragraph num="(i)"> <text>The food has exceeded 41°F or more for more than 4 hours; or</text> </paragraph> <paragraph num="(ii)"> <text>The time the food has been out of temperature is not verifiable;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §§B(12) and (13) and C(3) of this regulation, a potentially hazardous hot food that is placed on display is:</text> <paragraph num="(a)"> <text>Cooked according to Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Rapidly re-heated to an internal temperature of 165ºF or above if the food was below 135ºF for a verifiable period of not more than 4 hours; and</text> </paragraph> <paragraph num="(c)"> <text>Discarded if:</text> <paragraph num="(i)"> <text>The food was below 135°F for more than 4 hours; or</text> </paragraph> <paragraph num="(ii)"> <text>The time the food has been out of temperature is not verifiable;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A potentially hazardous bakery product that is stored at room temperature:</text> <paragraph num="(a)"> <text>Is manufactured, packaged, and labeled with a sell-by date only in an approved food processing plant meeting the requirements set forth in COMAR 10.15.04;</text> </paragraph> <paragraph num="(b)"> <text>Remains in the original package until sold to a consumer; and</text> </paragraph> <paragraph num="(c)"> <text>Is not offered for human consumption following expiration of the sell-by date;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Except as provided in §C(5) of this regulation, raw unpackaged food of animal origin is not offered for consumer self-service;</text> </paragraph> <paragraph num="(5)"> <text>Raw unpackaged foods of animal origin offered for consumer self-service are offered only:</text> <paragraph num="(a)"> <text>At buffets or salad bars that serve foods of animal origin such as sushi or raw shellfish;</text> </paragraph> <paragraph num="(b)"> <text>When the foods of animal origin are ready-to-cook individual portions for immediate cooking and consumption on premises, such as for Mongolian barbecue; or</text> </paragraph> <paragraph num="(c)"> <text>Frozen if shell-on shrimp and lobster;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>When uncovered food is placed on display in food operations, including buffets and cafeterias, the ready-to-eat food is protected by:</text> <paragraph num="(a)"> <text>Physical guards;</text> </paragraph> <paragraph num="(b)"> <text>Separation from potential contaminants; or</text> </paragraph> <paragraph num="(c)"> <text>Other effective methods acceptable to the approving authority;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>During pauses in food preparation or dispensing, utensils such as scoops, spoons, and dippers are stored:</text> <paragraph num="(a)"> <text>In a running water dipper well that provides a volume of fresh potable water sufficient to maintain the utensil in a sanitary condition;</text> </paragraph> <paragraph num="(b)"> <text>In hot water that is maintained at 135°F or above;</text> </paragraph> <paragraph num="(c)"> <text>With the handles above the top of the food in an open container;</text> </paragraph> <paragraph num="(d)"> <text>On a clean portion of the food preparation or cooking equipment, which has been cleaned and sanitized as set forth in Regulation .16 of this chapter; or</text> </paragraph> <paragraph num="(e)"> <text>In a clean, protected location if the utensils are used with a food that is not potentially hazardous;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Sugar, condiments, seasonings, and dressings are provided for self-service in individual packages or dispensed by methods that protect the food;</text> </paragraph> <paragraph num="(9)"> <text>Except for packaged non-potentially hazardous foods with the wrapping intact, portions of food once served to a customer are not served again; and</text> </paragraph> <paragraph num="(10)"> <text>Except for drinking cups reused by self-service consumers in a manner to prevent cross-contamination, employees and self-service customers do not reuse soiled tableware, including single service articles to:</text> <paragraph num="(a)"> <text>Provide second portions or refills; or</text> </paragraph> <paragraph num="(b)"> <text>Obtain additional food from display and serving equipment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>During the transportation of food:</text> <paragraph num="(1)"> <text>Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is maintained at 41°F or below or 135°F or above;</text> </paragraph> <paragraph num="(2)"> <text>From a food service facility to another location, the requirements set forth in §A(2) of this regulation are met;</text> </paragraph> <paragraph num="(3)"> <text>Frozen food is maintained frozen; and</text> </paragraph> <paragraph num="(4)"> <text>Food is in covered containers or completely wrapped or packaged to protect against contamination; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>During the preparation, storage, or service of food:</text> <paragraph num="(1)"> <text>Unsafe or adulterated food is discarded or reconditioned according to an approved procedure by the approving authority;</text> </paragraph> <paragraph num="(2)"> <text>Food that is not from an approved source as specified under Regulation .04 of this chapter is discarded;</text> </paragraph> <paragraph num="(3)"> <text>Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under Regulation .14A or B of this chapter is discarded; and</text> </paragraph> <paragraph num="(4)"> <text>Food shall be discarded if it is contaminated by employees, consumers, or other persons through:</text> <paragraph num="(a)"> <text>Contact with their hands;</text> </paragraph> <paragraph num="(b)"> <text>Bodily discharges, such as nasal or oral discharges; or</text> </paragraph> <paragraph num="(c)"> <text>Other means.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Food Protection During Outdoor Preparation and Service."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>During the use of outdoor cooking equipment, such as a barbeque grill, at a food service facility:</text> <paragraph num="(1)"> <text>Equipment:</text> <paragraph num="(a)"> <text>Is used only at the food service facility for service to patrons;</text> </paragraph> <paragraph num="(b)"> <text>Is located:</text> <paragraph num="(i)"> <text>On an impermeable surface;</text> </paragraph> <paragraph num="(ii)"> <text>In close proximity to the food preparation area of the food service facility; and</text> </paragraph> <paragraph num="(iii)"> <text>Away from parking areas, dumpsters, and patron entrances; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Meets the requirements set forth in Regulation .15 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Food is:</text> <paragraph num="(a)"> <text>Prepared for outdoor cooking inside the food service facility; and</text> </paragraph> <paragraph num="(b)"> <text>Protected from contamination during cooking and service; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When preparing beverages outdoors:</text> <paragraph num="(1)"> <text>Overhead protection is provided;</text> </paragraph> <paragraph num="(2)"> <text>Protection from contamination during storage is provided for ingredients, including:</text> <paragraph num="(a)"> <text>Ice;</text> </paragraph> <paragraph num="(b)"> <text>Drink mixes; and</text> </paragraph> <paragraph num="(c)"> <text>Condiments;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Containers are protected from contamination during storage; and</text> </paragraph> <paragraph num="(4)"> <text>Other than when only beer, wine, or soda is offered, a hand washing sink is provided in accordance with Regulation .18K and L of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Use of Time-Only with Potentially Hazardous Food."> <paragraph num="A."> <text>The approving authority may approve the use of time-only, rather than time in conjunction with temperature, for food protection as set forth in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Before using time-only while holding or preparing a potentially hazardous food:</text> <paragraph num="(a)"> <text>A written request is submitted to and approved by the approving authority for a specific food under specific conditions of preparation and service that includes:</text> <paragraph num="(i)"> <text>A record-keeping procedure that can verify safety intervention steps; and</text> </paragraph> <paragraph num="(ii)"> <text>Procedures for marking or otherwise identifying the food with the time by which it is to be either used or discarded; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The procedures for time-only are included in the food service facility's HACCP plan as a critical control point;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as otherwise approved by the approving authority, the maximum time limit under time-only control is 4 hours for a:</text> <paragraph num="(a)"> <text>Raw, working supply of potentially hazardous food during preparation, after which time the food is cooked or discarded; and</text> </paragraph> <paragraph num="(b)"> <text>Ready-to-eat potentially hazardous food held for immediate consumption, after which time the food not served is discarded;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Food has an initial temperature of:</text> <paragraph num="(a)"> <text>41°F or less upon removal from refrigeration; or</text> </paragraph> <paragraph num="(b)"> <text>135°F or more upon removal from cooking equipment; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Food that has been protected using time-only control is not served in a health care facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Food Preparation — Temperature and Cross-Contamination Control."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Food temperature measuring devices are:</text> <paragraph num="(1)"> <text>Used to monitor the temperature of potentially hazardous foods;</text> </paragraph> <paragraph num="(2)"> <text>Graduated and accurate within plus or minus 2°F;</text> </paragraph> <paragraph num="(3)"> <text>Calibrated annually or more frequently; and</text> </paragraph> <paragraph num="(4)"> <text>Cleaned and sanitized between uses in different foods to prevent cross-contamination;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The storage, thawing, cooking, cooling, reheating, and holding of a food:</text> <paragraph num="(1)"> <text>Are safe; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with this chapter;</text> </paragraph> </paragraph> <paragraph num="C."> <text>When a recipe in which more than one egg is broken and the eggs are combined and not prepared for immediate service:</text> <paragraph num="(1)"> <text>The mixture is stored under refrigeration at all times before cooking;</text> </paragraph> <paragraph num="(2)"> <text>The process is included in the food service facility's HACCP plan as a critical control point; and</text> </paragraph> <paragraph num="(3)"> <text>The mixture containing eggs is cooked to a minimum internal temperature of 155°F for 15 seconds;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Potentially hazardous food is thawed:</text> <paragraph num="(1)"> <text>In refrigerated units so that the temperature of the food does not exceed 41°F;</text> </paragraph> <paragraph num="(2)"> <text>Under potable running water that is at or below 70°F with sufficient force to agitate and float off loose particles;</text> </paragraph> <paragraph num="(3)"> <text>In a microwave oven only when the food will be immediately cooked in the microwave oven or immediately transferred to conventional cooking facilities as part of a continuous cooking process;</text> </paragraph> <paragraph num="(4)"> <text>If a potentially hazardous reduced oxygen packaged food:</text> <paragraph num="(a)"> <text>In the food’s airtight package at or below 41°F;</text> </paragraph> <paragraph num="(b)"> <text>At a lower temperature if specified by the manufacturer; or</text> </paragraph> <paragraph num="(c)"> <text>If fish or seafood, completely removed from the reduced oxygen environment or package prior to thawing;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>As part of a conventional cooking process; or</text> </paragraph> <paragraph num="(6)"> <text>By another method acceptable to the approving authority that has been scientifically proven to the approving authority to prevent the bacteriological, physical, or chemical contamination of food;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Employees prevent contact of exposed, ready-to-eat food with their bare hands by using:</text> <paragraph num="(1)"> <text>Gloves as specified under Regulation .14J of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Utensils such as:</text> <paragraph num="(a)"> <text>Tongs;</text> </paragraph> <paragraph num="(b)"> <text>Spatulas;</text> </paragraph> <paragraph num="(c)"> <text>Deli tissue; or</text> </paragraph> <paragraph num="(d)"> <text>Automatic dispensing equipment; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Cross-contamination is prevented by:</text> <paragraph num="(1)"> <text>Not allowing contact between ready-to-eat and raw foods;</text> </paragraph> <paragraph num="(2)"> <text>Storing and holding food so that:</text> <paragraph num="(a)"> <text>Ready-to-eat food is located above or otherwise segregated from raw food; and</text> </paragraph> <paragraph num="(b)"> <text>A food is protected from plumbing leaks and condensate drippage;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Using separate utensils and work surfaces for ready-to-eat food and foods requiring further preparation;</text> </paragraph> <paragraph num="(4)"> <text>Cleaning and sanitizing utensils and work surfaces between uses;</text> </paragraph> <paragraph num="(5)"> <text>Excluding sick workers from food handling in accordance with Regulation .14A and B of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Washing raw fruits and vegetables thoroughly to remove soil and other contaminants before cutting, cooking, or serving, with:</text> <paragraph num="(a)"> <text>Water; or</text> </paragraph> <paragraph num="(b)"> <text>Chemicals intended specifically for washing or peeling whole fruits and vegetables as specified in 21 CFR §173.315.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Food Preparation — Cooking."> <paragraph num="A."> <text>Except as provided in §§B—D of this regulation, the person-in-charge shall ensure that potentially hazardous food is cooked to the minimum internal temperature and for the specified holding time as follows:</text> <paragraph num="(1)"> <text>Chart 1. Summary of Minimum Cooking and Reheating Food Temperatures and Holding Times.</text> </paragraph> <paragraph num="(2)"> <text>A minimum internal temperature of 145°F for 15 seconds for:</text> <paragraph num="(a)"> <text>Shell eggs prepared for immediate service;</text> </paragraph> <paragraph num="(b)"> <text>Fish;</text> </paragraph> <paragraph num="(c)"> <text>Meat; and</text> </paragraph> <paragraph num="(d)"> <text>All other potentially hazardous food not specified in §A(3)—(7) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A minimum internal temperature of 155°F for 15 seconds or as specified in §A(1) of this regulation for:</text> <paragraph num="(a)"> <text>Shell eggs not prepared for immediate service;</text> </paragraph> <paragraph num="(b)"> <text>Ratites;</text> </paragraph> <paragraph num="(c)"> <text>Comminuted fish and meats;</text> </paragraph> <paragraph num="(d)"> <text>Game animals commercially raised for food; and</text> </paragraph> <paragraph num="(e)"> <text>Injected meats;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A minimum internal temperature of 130°F for 112 minutes or as specified in §A(1) of this chapter for:</text> <paragraph num="(a)"> <text>Whole or corned beef; and</text> </paragraph> <paragraph num="(b)"> <text>Pork and cured pork roasts;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A minimum internal temperature of 165°F for 15 seconds for:</text> <paragraph num="(a)"> <text>Poultry;</text> </paragraph> <paragraph num="(b)"> <text>Stuffed meat, pasta, or poultry;</text> </paragraph> <paragraph num="(c)"> <text>Exotic bird species;</text> </paragraph> <paragraph num="(d)"> <text>Wild game animals; and</text> </paragraph> <paragraph num="(e)"> <text>Stuffing containing fish, meat, or poultry;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A minimum internal temperature of 165°F and held for 2 minutes after removing from the oven for raw animal foods that are cooked in a microwave oven; and</text> </paragraph> <paragraph num="(7)"> <text>A minimum internal temperature of 135°F for fruits and vegetables cooked for hot holding.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may approve cooking times and temperatures other than those specified in §A of this regulation, if the cooking times and temperatures are scientifically proven to the Department to be as effective in killing foodborne pathogens as those specified in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>The person-in-charge may serve a consumer:</text> <paragraph num="(1)"> <text>Undercooked seared beefsteak when:</text> <paragraph num="(a)"> <text>Only whole muscle, intact beefsteak, is prepared;</text> </paragraph> <paragraph num="(b)"> <text>The meat is seared continuously on both top and bottom utilizing a heating environment that:</text> <paragraph num="(i)"> <text>Imparts a temperature at the surface of the intact steak of at least 145°F for 15 seconds; and</text> </paragraph> <paragraph num="(ii)"> <text>Achieves a cooked color change on all external surfaces; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A HACCP plan specifically developed for undercooked seared beefsteak is submitted and approved by the approving authority; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A food that is cooked, cooled, and then refrigerated in accordance with this chapter, such as roast beef for a sandwich, cold or warmed to any desired temperature for immediate consumption.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A health care facility may not serve a raw or undercooked animal food.</text> </paragraph> <paragraph num="E."> <text>Repealed.</text> </paragraph> <paragraph num="F."> <text>The person-in-charge shall ensure that a consumer advisory is issued when an animal food, such as beef, eggs, fish, lamb, pork, poultry, or shellfish, is served raw or undercooked by:</text> <paragraph num="(1)"> <text>Providing a written notification on:</text> <paragraph num="(a)"> <text>A menu or brochure;</text> </paragraph> <paragraph num="(b)"> <text>A deli case or menu board;</text> </paragraph> <paragraph num="(c)"> <text>A label statement;</text> </paragraph> <paragraph num="(d)"> <text>A table tent or placard; or</text> </paragraph> <paragraph num="(e)"> <text>Another written means that is visible and legible to the consumer;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Identifying food items on the items set forth in §F(1) of this regulation with an asterisk to a footnote that states the item:</text> <paragraph num="(a)"> <text>Is served raw;</text> </paragraph> <paragraph num="(b)"> <text>Is served undercooked;</text> </paragraph> <paragraph num="(c)"> <text>May be cooked to order upon specific consumer request; or</text> </paragraph> <paragraph num="(d)"> <text>Contains raw or undercooked ingredients; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providing this written statement: “Consuming raw or undercooked animal foods may increase your risk of contracting a foodborne illness, especially if you have certain medical conditions.”</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Food Preparation — Cooling and Reheating of Potentially Hazardous Foods."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>A potentially hazardous cooked food’s internal temperature is cooled from 135°F to 70°F within 2 hours and from 70°F to 41°F or less within an additional 4 hours;</text> </paragraph> <paragraph num="B."> <text>A potentially hazardous food for cold service, such as a reconstituted food, salad, or canned meat, is cooled to an internal temperature of 41°F within 4 hours;</text> </paragraph> <paragraph num="C."> <text>Cooling of potentially hazardous food is accomplished using one or a combination of the following methods:</text> <paragraph num="(1)"> <text>Refrigerate in shallow pans with food not over 3 inches deep;</text> </paragraph> <paragraph num="(2)"> <text>Reduce food mass by separating foods into smaller or thinner portions;</text> </paragraph> <paragraph num="(3)"> <text>Use rapid cooling equipment;</text> </paragraph> <paragraph num="(4)"> <text>Use ice water baths combined with frequent stirring;</text> </paragraph> <paragraph num="(5)"> <text>Use containers that facilitate heat transfer;</text> </paragraph> <paragraph num="(6)"> <text>Add ice made from potable water as an ingredient;</text> </paragraph> <paragraph num="(7)"> <text>Refrigerate loosely covered or allow the food to remain uncovered until cooled if the food is protected from overhead contamination; or</text> </paragraph> <paragraph num="(8)"> <text>Another effective method acceptable to the approving authority based on applicable state and local laws, regulations, and ordinances; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Potentially hazardous food is reheated:</text> <paragraph num="(1)"> <text>Within 2 hours to a minimum internal temperature of 165°F for 15 seconds for food that is cooked, cooled, and refrigerated before being placed into hot food holding equipment;</text> </paragraph> <paragraph num="(2)"> <text>Within 2 hours to a minimum internal temperature of 135°F for ready-to-eat food taken from a commercially processed, hermetically sealed container or from an intact package from a food processing plant that is inspected by a food regulatory authority for hot holding;</text> </paragraph> <paragraph num="(3)"> <text>Using the same time and temperature conditions specified in Regulation .10A of this chapter for initial cooking for remaining unsliced portions of roasts for hot holding; and</text> </paragraph> <paragraph num="(4)"> <text>Within 2 hours or less, to a minimum internal temperature of 165°F for 15 seconds in a microwave oven for hot holding and then stirred, covered, and allowed to stand covered for 2 minutes after reheating.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Food Labeling."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Except as specified in §B of this regulation, each item of packaged food has a label containing the following information:</text> <paragraph num="(a)"> <text>The common name of the food or a descriptive identity statement;</text> </paragraph> <paragraph num="(b)"> <text>If made from two or more ingredients:</text> <paragraph num="(i)"> <text>A list of ingredients in descending order of prominence by weight; and</text> </paragraph> <paragraph num="(ii)"> <text>A declaration of artificial color or flavor and chemical preservatives;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An accurate declaration of the quantity of the package contents by weight in both metric and English units;</text> </paragraph> <paragraph num="(d)"> <text>The name and place of business of the manufacturer, packer, or distributor;</text> </paragraph> <paragraph num="(e)"> <text>Except as exempted in 21 U.S.C. §343(q)(3)—(5), the nutrition labeling specified in 21 CFR Part 101 and 9 CFR Part 317; and</text> </paragraph> <paragraph num="(f)"> <text>The name of the food source for each major food allergen that is contained in the food unless the food source is already part of the common or usual name of the respective ingredient;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The use of canthaxanthin as a color additive in salmonid fish is disclosed by written means, such as a counter card;</text> </paragraph> <paragraph num="(3)"> <text>Bulk food available for consumer self-dispensing is prominently labeled with the following information in plain view of the consumer:</text> <paragraph num="(a)"> <text>The manufacturer's label that was provided with the food; or</text> </paragraph> <paragraph num="(b)"> <text>A card, sign, or other method of notification that includes the information specified in §A(1)(a), (b), and (f) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A food service facility may offer for sale bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification without a label if:</text> <paragraph num="(1)"> <text>A health, nutrient, or other claim relating to the unpackaged food is not made on a card or sign; and</text> </paragraph> <paragraph num="(2)"> <text>The food is manufactured or prepared on the premises of the food service facility or at another food service facility owned by the same person.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Food Protection from Poisonous or Toxic Materials."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Except for packaged poisonous or toxic products offered in their unopened original containers for retail sale, only poisonous or toxic materials needed to maintain sanitary conditions and to sanitize equipment and utensils are located in a food or food utensil area;</text> </paragraph> <paragraph num="B."> <text>A container of a poisonous or toxic material is:</text> <paragraph num="(1)"> <text>Kept in the original bulk container before use;</text> </paragraph> <paragraph num="(2)"> <text>Prominently and distinctively marked or labeled for easy identification; and</text> </paragraph> <paragraph num="(3)"> <text>Used according to the manufacturer's directions;</text> </paragraph> </paragraph> <paragraph num="C."> <text>When not in use, poisonous or toxic materials are stored in a:</text> <paragraph num="(1)"> <text>Cabinet used for no other purpose; or</text> </paragraph> <paragraph num="(2)"> <text>Room not used for food storage, food preparation, or equipment and utensil washing or storage;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A bactericide, cleaning compound, or other compound intended for use on food-contact surfaces is not:</text> <paragraph num="(1)"> <text>Stored in the same cabinet with an insecticide, rodenticide, or other poisonous or toxic material; or</text> </paragraph> <paragraph num="(2)"> <text>Used or stored in a way that will leave a toxic residue on food-contact surfaces;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A poisonous or toxic material is not used or stored in a way that will:</text> <paragraph num="(1)"> <text>Contaminate:</text> <paragraph num="(a)"> <text>Food; or</text> </paragraph> <paragraph num="(b)"> <text>Food equipment; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Constitute a potential hazard to:</text> <paragraph num="(a)"> <text>Employees; or</text> </paragraph> <paragraph num="(b)"> <text>Customers;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A medication is not stored in a food storage, preparation, processing, or service area;</text> </paragraph> <paragraph num="G."> <text>First aid supplies are stored in a way that prevents contamination of:</text> <paragraph num="(1)"> <text>Food; or</text> </paragraph> <paragraph num="(2)"> <text>Food-contact surfaces; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>A container previously used to store poisonous or toxic materials is not used to store, transport, or dispense:</text> <paragraph num="(1)"> <text>Food; or</text> </paragraph> <paragraph num="(2)"> <text>Items that will come into contact with food.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Personnel Health and Sanitation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>As set forth in COMAR 10.06.01.06E, a food handler does not serve or handle food intended for public consumption if the food handler:</text> <paragraph num="(1)"> <text>Has any of the following diseases:</text> <paragraph num="(a)"> <text>Diarrhea caused by Entamoeba histolytica;</text> </paragraph> <paragraph num="(b)"> <text>Cholera;</text> </paragraph> <paragraph num="(c)"> <text>Disease causing diarrhea, unless physician-certified as noninfectious;</text> </paragraph> <paragraph num="(d)"> <text>E. coli O157:H7;</text> </paragraph> <paragraph num="(e)"> <text>Hepatitis A;</text> </paragraph> <paragraph num="(f)"> <text>Diarrhea caused by Salmonella;</text> </paragraph> <paragraph num="(g)"> <text>Shigellosis;</text> </paragraph> <paragraph num="(h)"> <text>Streptococcal infection caused by group A beta-hemolytic Streptococcus; or</text> </paragraph> <paragraph num="(i)"> <text>Typhoid fever; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is a carrier of Salmonella Typhi;</text> </paragraph> </paragraph> <paragraph num="B."> <text>An employee experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth does not work with:</text> <paragraph num="(1)"> <text>Exposed food;</text> </paragraph> <paragraph num="(2)"> <text>Clean equipment, utensils, and linens; or</text> </paragraph> <paragraph num="(3)"> <text>Unwrapped single service or single use articles;</text> </paragraph> </paragraph> <paragraph num="C."> <text>An employee who has a disease that may be transmissible through food reports the condition to the person-in-charge;</text> </paragraph> <paragraph num="D."> <text>The approving authority is notified when an employee of a food service facility is known to have or is suspected of having a disease that is transmissible by food;</text> </paragraph> <paragraph num="E."> <text>An employee washes hands and exposed arm areas thoroughly with soap and warm water:</text> <paragraph num="(1)"> <text>Before handling:</text> <paragraph num="(a)"> <text>Exposed foods; or</text> </paragraph> <paragraph num="(b)"> <text>Food-contact surfaces;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before starting work;</text> </paragraph> <paragraph num="(3)"> <text>As often as required to remove soil and contamination;</text> </paragraph> <paragraph num="(4)"> <text>After using toilet facilities; and</text> </paragraph> <paragraph num="(5)"> <text>Before and between glove use;</text> </paragraph> </paragraph> <paragraph num="F."> <text>An employee washes hands, exposed portions of the arms, between the fingers, and underneath the fingernails:</text> <paragraph num="(1)"> <text>With a cleaning compound;</text> </paragraph> <paragraph num="(2)"> <text>At a hand washing facility that is equipped as specified in Regulation .18K and L of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>By:</text> <paragraph num="(a)"> <text>Vigorously rubbing together the surfaces of lathered hands and arms for at least 20 seconds;</text> </paragraph> <paragraph num="(b)"> <text>Cleaning under the nails with a brush if needed; and</text> </paragraph> <paragraph num="(c)"> <text>Thoroughly rinsing the hands and arms with clean water;</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An employee keeps hands clean while engaged in handling food and food-contact surfaces;</text> </paragraph> <paragraph num="H."> <text>An employee who handles exposed food and food-contact surfaces:</text> <paragraph num="(1)"> <text>Keeps fingernails clean and neatly trimmed;</text> </paragraph> <paragraph num="(2)"> <text>Unless wearing gloves that are in good repair, does not wear fingernail polish or artificial fingernails;</text> </paragraph> <paragraph num="(3)"> <text>Except for a plain, smooth ring such as a wedding band, does not wear jewelry;</text> </paragraph> <paragraph num="(4)"> <text>Wears outer garments that are clean;</text> </paragraph> <paragraph num="(5)"> <text>Uses hairnets, caps, or other effective hair restraints in order to keep hair from contacting food and food-contact surfaces;</text> </paragraph> <paragraph num="(6)"> <text>Maintains personal cleanliness; and</text> </paragraph> <paragraph num="(7)"> <text>Except as provided in §L of this regulation, does not eat, drink, or use tobacco in any form while working;</text> </paragraph> </paragraph> <paragraph num="I."> <text>An employee does not use bare hands for handling ready-to-eat foods, as set forth in Regulation .09E of this chapter;</text> </paragraph> <paragraph num="J."> <text>An employee using gloves to protect exposed food:</text> <paragraph num="(1)"> <text>Uses gloves only for one task;</text> </paragraph> <paragraph num="(2)"> <text>Does not use the same gloves while working with ready-to-eat food and raw food; and</text> </paragraph> <paragraph num="(3)"> <text>Discards used gloves when:</text> <paragraph num="(a)"> <text>The gloves are damaged or soiled;</text> </paragraph> <paragraph num="(b)"> <text>An interruption occurs in the operation; or</text> </paragraph> <paragraph num="(c)"> <text>After 2 hours of continuous use;</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>An employee receives training in proper food handling and sanitation as it relates to assigned duties; and</text> </paragraph> <paragraph num="L."> <text>When in a food preparation or utensil washing area, an employee:</text> <paragraph num="(1)"> <text>Drinks only from a covered beverage container; and</text> </paragraph> <paragraph num="(2)"> <text>Handles the container in a way that prevents contamination of:</text> <paragraph num="(a)"> <text>The employee's hands;</text> </paragraph> <paragraph num="(b)"> <text>Exposed food;</text> </paragraph> <paragraph num="(c)"> <text>Clean equipment;</text> </paragraph> <paragraph num="(d)"> <text>Utensils;</text> </paragraph> <paragraph num="(e)"> <text>Linens; and</text> </paragraph> <paragraph num="(f)"> <text>Unwrapped single service and single use articles.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Food Equipment and Utensils."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Except as provided in §§A(2) and (14) and B of this regulation, food equipment meets one or more of the following design standards:</text> <paragraph num="(a)"> <text>National Sanitation Foundation (NSF) or equivalent sanitation certification from:</text> <paragraph num="(i)"> <text>The Etlsemko division of Intertek Group PLC (Intertek ETL SEMKO);</text> </paragraph> <paragraph num="(ii)"> <text>Canadian Standards Association (CSA); or</text> </paragraph> <paragraph num="(iii)"> <text>Underwriters Laboratories (UL);</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Baking Industry Sanitation Standards Committee;</text> </paragraph> <paragraph num="(c)"> <text>National Automation Merchandizing Association;</text> </paragraph> <paragraph num="(d)"> <text>International Association of Milk and Food Sanitarian's "3-A Sanitary Standards"; or</text> </paragraph> <paragraph num="(e)"> <text>Another applicable published standard acceptable to the approving authority;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed;</text> </paragraph> <paragraph num="(3)"> <text>Equipment and utensils are designed, constructed, and maintained to:</text> <paragraph num="(a)"> <text>Accomplish the intended and required functions;</text> </paragraph> <paragraph num="(b)"> <text>Protect food from internal and external contamination;</text> </paragraph> <paragraph num="(c)"> <text>Be durable under normal conditions and operations;</text> </paragraph> <paragraph num="(d)"> <text>Be resistant to:</text> <paragraph num="(i)"> <text>Denting;</text> </paragraph> <paragraph num="(ii)"> <text>Buckling;</text> </paragraph> <paragraph num="(iii)"> <text>Pitting;</text> </paragraph> <paragraph num="(iv)"> <text>Chipping;</text> </paragraph> <paragraph num="(v)"> <text>Crazing; and</text> </paragraph> <paragraph num="(vi)"> <text>Excessive wear;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Have non-food contact surfaces where exposed to splash, food debris, or other soils that are:</text> <paragraph num="(i)"> <text>Smooth;</text> </paragraph> <paragraph num="(ii)"> <text>Washable; and</text> </paragraph> <paragraph num="(iii)"> <text>Readily accessible;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Withstand repeated scrubbing, scouring, corrosive action of food, cleansers, and sanitizing agents; and</text> </paragraph> <paragraph num="(g)"> <text>Prevent harboring of soils, bacteria, or pests:</text> <paragraph num="(i)"> <text>In or on the equipment; and</text> </paragraph> <paragraph num="(ii)"> <text>Between the equipment and other equipment, floors, walls, or supports;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Materials used as food contact surfaces of equipment are:</text> <paragraph num="(a)"> <text>Nontoxic;</text> </paragraph> <paragraph num="(b)"> <text>Unable to contaminate or be absorbed by food under the conditions of use;</text> </paragraph> <paragraph num="(c)"> <text>Non-porous and nonabsorbent; and</text> </paragraph> <paragraph num="(d)"> <text>Except for the use of cast iron as a food contact material if the surface is to be heated, corrosion resistant;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Food contact surfaces of equipment and utensils are designed, constructed, and maintained to be:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Easily cleanable;</text> </paragraph> <paragraph num="(c)"> <text>In good repair;</text> </paragraph> <paragraph num="(d)"> <text>Free of difficult to clean internal corners and crevices;</text> </paragraph> <paragraph num="(e)"> <text>Self-emptying or self-draining if an interior surface;</text> </paragraph> <paragraph num="(f)"> <text>Visible or readily disassembled for inspection; and</text> </paragraph> <paragraph num="(g)"> <text>Readily:</text> <paragraph num="(i)"> <text>Accessible for manual cleaning without tools; or</text> </paragraph> <paragraph num="(ii)"> <text>Disassembled with the use of simple tools kept available near the equipment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Equipment designed for pressurized cleaning-in-place is designed, constructed, and maintained to:</text> <paragraph num="(a)"> <text>Fully circulate cleaning and sanitizing solutions through a fixed system in which the solutions will contact all interior food contact surfaces;</text> </paragraph> <paragraph num="(b)"> <text>Self-drain or otherwise completely evacuate all cleaning solutions; and</text> </paragraph> <paragraph num="(c)"> <text>Effectively clean and sanitize all food contact surfaces without disassembly;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Cutting blocks, bakers tables, and similar wood food contact surfaces are made from:</text> <paragraph num="(a)"> <text>Hard maple; or</text> </paragraph> <paragraph num="(b)"> <text>Another material that is:</text> <paragraph num="(i)"> <text>Nontoxic;</text> </paragraph> <paragraph num="(ii)"> <text>Smooth; and</text> </paragraph> <paragraph num="(iii)"> <text>Free of cracks, crevices, and open seams;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Lubricants used on bearings and gears of equipment are food-grade;</text> </paragraph> <paragraph num="(9)"> <text>Except for equipment that is portable, equipment that is placed on tables or counters is:</text> <paragraph num="(a)"> <text>Sealed in place;</text> </paragraph> <paragraph num="(b)"> <text>Mounted on legs or feet at least 4 inches high; or</text> </paragraph> <paragraph num="(c)"> <text>Installed to allow cleaning of the equipment and adjacent areas;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Floor-mounted equipment is:</text> <paragraph num="(a)"> <text>Elevated:</text> <paragraph num="(i)"> <text>At least 6 inches above the floor; and</text> </paragraph> <paragraph num="(ii)"> <text>So that food contact surfaces are at least 18 inches above the floor; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Placed so that there is sufficient space for cleaning between:</text> <paragraph num="(i)"> <text>Adjoining units; and</text> </paragraph> <paragraph num="(ii)"> <text>A unit and the adjacent walls;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>The spaces between adjoining equipment are closed and sealed if exposed to seepage;</text> </paragraph> <paragraph num="(12)"> <text>Aisles or working spaces between equipment and between equipment and walls are:</text> <paragraph num="(a)"> <text>Unobstructed and of sufficient width to permit employees to perform duties without contaminating food or food-contact surfaces by clothing or personal contact; and</text> </paragraph> <paragraph num="(b)"> <text>In a new facility or a facility that is remodeled, a minimum width of:</text> <paragraph num="(i)"> <text>3 feet where food preparation occurs on only one side of the aisle;</text> </paragraph> <paragraph num="(ii)"> <text>4 feet where food preparation occurs on both sides of the aisle and employees work back to back;</text> </paragraph> <paragraph num="(iii)"> <text>5 feet where food preparation occurs on both sides of the aisle, employees work back to back, and other employees must pass through the area; or</text> </paragraph> <paragraph num="(iv)"> <text>Another width approved by the approving authority based on a review that indicates compliance with §A(12)(a) of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>Equipment is installed and located to limit the potential for cross-contamination of food;</text> </paragraph> <paragraph num="(14)"> <text>When an existing piece of equipment ceases to operate:</text> <paragraph num="(a)"> <text>Equipment intended for temporary use is:</text> <paragraph num="(i)"> <text>Acceptable to the approving authority; and</text> </paragraph> <paragraph num="(ii)"> <text>In compliance with §A(3)—(8) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Equipment is replaced:</text> <paragraph num="(i)"> <text>With equipment that meets the requirements of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Within 30 working days from the date the permanent replacement plan required in §A(14)(c) of this regulation is accepted by the approving authority; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The approving authority is provided plans for permanent replacement of the failed unit within 10 working days after the failure of the unit; and</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>A vending machine containing potentially hazardous foods has an automatic control that prevents the machine from vending food:</text> <paragraph num="(a)"> <text>If there is a power failure, mechanical failure, or other condition resulting in an internal machine temperature that cannot maintain food temperatures as specified in Regulation .06B(7) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Until serviced and working properly.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The approving authority may allow the use of equipment that meets §A(3)—(10) of this regulation but fails to comply with §A(1) of this regulation if a review indicates the equipment and its use are:</text> <paragraph num="(1)"> <text>Not harmful to public health; and</text> </paragraph> <paragraph num="(2)"> <text>Consistent with industry standards and practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Cleaning and Sanitizing Equipment and Utensils."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Food contact surfaces of equipment and utensils are effectively cleaned and sanitized by:</text> <paragraph num="(1)"> <text>Removing soil and food particles by one or more of the following:</text> <paragraph num="(a)"> <text>Flushing;</text> </paragraph> <paragraph num="(b)"> <text>Soaking;</text> </paragraph> <paragraph num="(c)"> <text>Scraping;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cleaning with a suitable commercial detergent;</text> </paragraph> <paragraph num="(3)"> <text>Rinsing with potable water; and</text> </paragraph> <paragraph num="(4)"> <text>Sanitizing, using:</text> <paragraph num="(a)"> <text>Immersion in hot water of 170°F or higher temperature for at least 30 seconds;</text> </paragraph> <paragraph num="(b)"> <text>Immersion in a chemical sanitizer that is proven to kill pathogens effectively:</text> <paragraph num="(i)"> <text>In accordance with the manufacturer's label use instructions; or</text> </paragraph> <paragraph num="(ii)"> <text>As set forth in §C(1) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For equipment that is not sanitized by the methods set forth in §C(1) of this regulation:</text> <paragraph num="(i)"> <text>Live steam from a hose, provided that the steam can be confined within the equipment;</text> </paragraph> <paragraph num="(ii)"> <text>A rinse with boiling water; or</text> </paragraph> <paragraph num="(iii)"> <text>A spray or swab with a chemical sanitizing solution of at least the minimum strength stated in §C(1) of this regulation;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Cleaning and sanitization occur:</text> <paragraph num="(1)"> <text>As often as needed to prevent food contamination;</text> </paragraph> <paragraph num="(2)"> <text>After each use;</text> </paragraph> <paragraph num="(3)"> <text>Between an interruption in food preparation greater than 4 hours; and</text> </paragraph> <paragraph num="(4)"> <text>Except for food contact surfaces of equipment or utensils within holding units that are maintained at proper temperatures, after a continuous use of 4 hours;</text> </paragraph> </paragraph> <paragraph num="C."> <text>When sanitizer is used for the manual sanitization of food contact surfaces of equipment and utensils:</text> <paragraph num="(1)"> <text>The minimum level of sanitizer provided is:</text> <paragraph num="(a)"> <text>50 parts per million chlorine with a minimum water temperature of 75°F and a minimum contact time of 7 seconds;</text> </paragraph> <paragraph num="(b)"> <text>12.5—25 parts per million iodine with a minimum water temperature of 75°F and a minimum contact time of 30 seconds; or</text> </paragraph> <paragraph num="(c)"> <text>The concentration indicated on the manufacturer's label with a minimum contact time of 30 seconds for quaternary ammonium compound; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A test kit or other device that accurately measures concentration of the sanitizer in parts per million is provided and used to check that the minimum level of sanitizer is accurate;</text> </paragraph> </paragraph> <paragraph num="D."> <text>When hot water is used as the sanitizing agent in manual operations, a graduated thermometer is provided that is:</text> <paragraph num="(1)"> <text>Accurate within plus or minus 2°F;</text> </paragraph> <paragraph num="(2)"> <text>Calibrated annually or more frequently;</text> </paragraph> <paragraph num="(3)"> <text>Located near the sink; and</text> </paragraph> <paragraph num="(4)"> <text>Used frequently to check water temperature;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A three-compartment sink is:</text> <paragraph num="(1)"> <text>Provided and used wherever warewashing is conducted manually;</text> </paragraph> <paragraph num="(2)"> <text>Adequate in length, width, and depth to accommodate the largest equipment items and utensils;</text> </paragraph> <paragraph num="(3)"> <text>Supplied with hot and cold running water at each sink compartment; and</text> </paragraph> <paragraph num="(4)"> <text>If used for tasks other than warewashing, such as washing wiping cloths or produce or thawing food:</text> <paragraph num="(a)"> <text>Is washed and sanitized before and after the sink is used for a different task; and</text> </paragraph> <paragraph num="(b)"> <text>Does not contain an automatic chemical dispenser;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Dish tables or integral drainboards are:</text> <paragraph num="(1)"> <text>Of adequate size for proper handling of soiled utensils before washing and for cleaned utensils following rinsing or sanitization;</text> </paragraph> <paragraph num="(2)"> <text>Located and constructed so the tables or drainboards do not interfere with the proper use of the warewashing facilities; and</text> </paragraph> <paragraph num="(3)"> <text>Not required for cooks' and bakers' rinse sinks;</text> </paragraph> </paragraph> <paragraph num="G."> <text>When spray-type warewashing machines are used:</text> <paragraph num="(1)"> <text>The machines are installed:</text> <paragraph num="(a)"> <text>According to manufacturer's specifications; and</text> </paragraph> <paragraph num="(b)"> <text>To provide effective cleaning and sanitization of equipment and utensils;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The manufacturer's specifications are listed on a data plate that is permanently affixed to the machine;</text> </paragraph> <paragraph num="(3)"> <text>If manufacturer's specifications for wash and rinse water temperature do not exist, the following standards are followed:</text> <paragraph num="(a)"> <text>For machines using chemical sanitization, the wash and final rinse water temperature is at least 120°F; or</text> </paragraph> <paragraph num="(b)"> <text>For machines using hot water sanitization, the wash water is at least:</text> <paragraph num="(i)"> <text>160°F for single tank conveyor machines; and</text> </paragraph> <paragraph num="(ii)"> <text>150°F for other types of machines;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For machines using hot water sanitization, the final or fresh rinse water temperature is at least:</text> <paragraph num="(i)"> <text>180°F at the entrance of the manifold; or</text> </paragraph> <paragraph num="(ii)"> <text>160°F when a pumped rinse is provided;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Wash water is kept clean and rinse water tanks are protected by:</text> <paragraph num="(i)"> <text>Distance;</text> </paragraph> <paragraph num="(ii)"> <text>Baffles; or</text> </paragraph> <paragraph num="(iii)"> <text>Other means to minimize the entry of wash water into the rinse water;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The flow pressure is not less than 15 or more than 25 pounds per square inch on the water line immediately adjacent to the final rinse control valve;</text> </paragraph> <paragraph num="(f)"> <text>Except for a pumped or recirculated final rinse, a pressure gauge is provided immediately upstream from the final rinse control valve to check the flow pressure of the final rinse water; and</text> </paragraph> <paragraph num="(g)"> <text>An easily readable thermometer is provided to measure water temperature with an accuracy of plus or minus 2°F:</text> <paragraph num="(i)"> <text>In each tank of the warewashing machine; and</text> </paragraph> <paragraph num="(ii)"> <text>As the final rinse water enters the manifold;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Jets, nozzles, and all other parts of each machine are maintained free of:</text> <paragraph num="(a)"> <text>Chemical deposits;</text> </paragraph> <paragraph num="(b)"> <text>Debris; and</text> </paragraph> <paragraph num="(c)"> <text>Other soil; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If used, automatic detergent dispensers are maintained and operating;</text> </paragraph> </paragraph> <paragraph num="H."> <text>All warewashing machines are thoroughly cleaned as often as needed throughout the day to:</text> <paragraph num="(1)"> <text>Prevent recontamination of equipment and utensils; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the equipment performs the equipment's intended function;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A pre-rinse device is provided for all warewashing machines;</text> </paragraph> <paragraph num="J."> <text>Equipment and utensils are placed in racks, trays, baskets, or on conveyors after flushing, scraping, or soaking so that food contact surfaces are:</text> <paragraph num="(1)"> <text>Subject to unobstructed application of detergent wash;</text> </paragraph> <paragraph num="(2)"> <text>Rinsed thoroughly with clean rinse water to remove particulate matter and detergent residues; and</text> </paragraph> <paragraph num="(3)"> <text>Drained;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Warewashing machines using chemicals for sanitization meet the following additional requirements:</text> <paragraph num="(1)"> <text>Chemicals added for sanitization purposes are automatically dispensed; and</text> </paragraph> <paragraph num="(2)"> <text>The chemical sanitizer used:</text> <paragraph num="(a)"> <text>Is listed in 21 CFR §178.1010; and</text> </paragraph> <paragraph num="(b)"> <text>Provides the equivalent bactericidal effect of a solution containing at least 50 parts per million of chlorine; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A test kit or other device that accurately measures the concentration of the sanitizing solution is used;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Written approval is obtained from the approving authority when any other type of machine, device, or facilities and procedures for warewashing will be used based on a review that indicates compliance with §A of this regulation;</text> </paragraph> <paragraph num="M."> <text>Non-food contact surfaces of equipment are cleaned frequently enough to preclude the accumulation of soil residues; and</text> </paragraph> <paragraph num="N."> <text>Wiping cloths are:</text> <paragraph num="(1)"> <text>Used only for wiping food spills;</text> </paragraph> <paragraph num="(2)"> <text>Free of food debris when used dry for wiping food spills on tableware; and</text> </paragraph> <paragraph num="(3)"> <text>Rinsed and stored in one of the sanitizing solutions specified in §C(1) of this regulation when used wet for wiping spills from the surfaces of equipment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Storage and Handling of Cleaned Equipment and Utensils."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Contamination of food-contact surfaces of cleaned and sanitized equipment and utensils is prevented by handling:</text> <paragraph num="(1)"> <text>Cleaned spoons, knives, and forks by the utensil's handles only; and</text> </paragraph> <paragraph num="(2)"> <text>Cleaned cups, glasses, and bowls so that hands do not contact inside surfaces or mouth-contact surfaces;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The food-contact surfaces of equipment are protected from:</text> <paragraph num="(1)"> <text>Splash;</text> </paragraph> <paragraph num="(2)"> <text>Dust; and</text> </paragraph> <paragraph num="(3)"> <text>Other contamination;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Cleaned and sanitized food equipment, portable equipment, and utensils are stored:</text> <paragraph num="(1)"> <text>A minimum of 18 inches above the floor when not fully protected by an enclosure with doors;</text> </paragraph> <paragraph num="(2)"> <text>In a clean, dry location; and</text> </paragraph> <paragraph num="(3)"> <text>In a space that affords protection from splash, dust, and other contamination;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Utensils are:</text> <paragraph num="(1)"> <text>Air dried before being stored; or</text> </paragraph> <paragraph num="(2)"> <text>Stored in a self-draining position on hooks or racks constructed of a corrosion resistant material;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Stored containers and utensils are covered or inverted whenever possible;</text> </paragraph> <paragraph num="F."> <text>Flatware is stored in containers designed to present the handle to the employee or customer;</text> </paragraph> <paragraph num="G."> <text>Toilet rooms or vestibules are not used to store:</text> <paragraph num="(1)"> <text>Food equipment;</text> </paragraph> <paragraph num="(2)"> <text>Utensils; or</text> </paragraph> <paragraph num="(3)"> <text>Single service articles; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>Single service articles are:</text> <paragraph num="(1)"> <text>Stored in closed cartons or containers to protect the articles from contamination;</text> </paragraph> <paragraph num="(2)"> <text>Handled and dispensed in a manner that prevents contamination of surfaces that come into contact with food or the mouth of the user; and</text> </paragraph> <paragraph num="(3)"> <text>Used only once.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Control of Sanitary Facilities."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Potable water is:</text> <paragraph num="(1)"> <text>Obtained from a water supply system that complies with Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.04; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the standards of quality specified in Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.01;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Non-potable water for non-culinary purposes such as air conditioning or fire protection is used only if the system complies with §H(3) of this regulation;</text> </paragraph> <paragraph num="C."> <text>Except for a temporary food service facility where water under pressure is not available, hot and cold running water under pressure is provided:</text> <paragraph num="(1)"> <text>In all areas where:</text> <paragraph num="(a)"> <text>Food is prepared; and</text> </paragraph> <paragraph num="(b)"> <text>Equipment and utensils are washed; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>With sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the facility;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Drinking water, if not dispensed through the water supply system of the food service facility, is potable and stored in a container that meets all applicable laws, ordinances, and regulations;</text> </paragraph> <paragraph num="E."> <text>Steam that contacts food is free from deleterious or harmful matter that might adulterate food;</text> </paragraph> <paragraph num="F."> <text>All water-carried sewage is disposed of by:</text> <paragraph num="(1)"> <text>A public sewerage system; or</text> </paragraph> <paragraph num="(2)"> <text>An approved sewage disposal system constructed and operated in conformance with applicable State and local laws, ordinances, and regulations;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Where water-carried disposal methods are not possible, non-water-carried sewage disposal facilities are utilized if:</text> <paragraph num="(1)"> <text>The method has been approved by the approving authority as meeting State and local requirements; and</text> </paragraph> <paragraph num="(2)"> <text>The facilities are:</text> <paragraph num="(a)"> <text>In conformance with applicable State and local laws, ordinances, and regulations; and</text> </paragraph> <paragraph num="(b)"> <text>Located outside and not attached to the establishment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Plumbing is sized, installed, and maintained so that:</text> <paragraph num="(1)"> <text>The plumbing complies with applicable State and local plumbing laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(2)"> <text>The potable water supply system is:</text> <paragraph num="(a)"> <text>Installed in a manner that prevents backflow or backsiphonage; and</text> </paragraph> <paragraph num="(b)"> <text>Not connected with a non-potable water system in a manner that would allow non-potable water to be drawn or discharged into the potable water supply system;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The piping of a non-potable water system is:</text> <paragraph num="(a)"> <text>Marked so that the piping is readily distinguishable from piping that carries potable water, such as with distinctive yellow-colored paint; and</text> </paragraph> <paragraph num="(b)"> <text>Not connected to equipment or other outlets in the food preparation area;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Indirect waste piping is provided to a:</text> <paragraph num="(a)"> <text>Food preparation or utensil washing sink;</text> </paragraph> <paragraph num="(b)"> <text>Refrigerator coil;</text> </paragraph> <paragraph num="(c)"> <text>Ice making machine;</text> </paragraph> <paragraph num="(d)"> <text>Steam kettle;</text> </paragraph> <paragraph num="(e)"> <text>Coffee urn or brewer;</text> </paragraph> <paragraph num="(f)"> <text>Hot or cold drink machine;</text> </paragraph> <paragraph num="(g)"> <text>Steam table;</text> </paragraph> <paragraph num="(h)"> <text>Potato peeler;</text> </paragraph> <paragraph num="(i)"> <text>Warewashing machine, unless:</text> <paragraph num="(i)"> <text>The machine is located within 5 feet of a trapped floor drain; and</text> </paragraph> <paragraph num="(ii)"> <text>The waste piping is connected directly to the inlet side of a floor drain trap vented in conformance with applicable State and local laws, ordinances, and regulations; and</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Similar piece of equipment in which food, portable equipment, or utensils are placed;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Each compartment of a multiple compartment sink is indirectly drained to a trapped and vented plumbing receptor through an air gap that complies with State and local laws, regulations, and ordinances:</text> <paragraph num="(a)"> <text>From a separate pipe through the air gap and into the plumbing receptor; or</text> </paragraph> <paragraph num="(b)"> <text>Through the air gap into a single manifolded branch and into the plumbing receptor;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Plumbing receptors receiving the discharge of indirect waste pipes:</text> <paragraph num="(a)"> <text>Have a shape and capacity that will prevent splashing or flooding; and</text> </paragraph> <paragraph num="(b)"> <text>Are accessible for cleaning and inspection;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Food waste grinders are connected and trapped separately from other fixtures or sink compartments;</text> </paragraph> <paragraph num="(8)"> <text>Floor drains subject to evaporation have:</text> <paragraph num="(a)"> <text>A water seal of at least 4 inches;</text> </paragraph> <paragraph num="(b)"> <text>Water fed from a plumbing fixture that complies with State and local laws, regulations, and ordinances; or</text> </paragraph> <paragraph num="(c)"> <text>An automatic priming device that complies with State and local laws, regulations, and ordinances;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Floor drains in storerooms, refrigerated rooms, walk-in coolers, or other locations where food is stored, have indirect waste piping;</text> </paragraph> <paragraph num="(10)"> <text>Hand sinks in food preparation tables and counters discharge through an air gap into a floor sink or receptor that is trapped and vented; and</text> </paragraph> <paragraph num="(11)"> <text>Except when required by building design, waste pipes and fixtures are:</text> <paragraph num="(a)"> <text>Not located over food storage, preparation, or serving areas; and</text> </paragraph> <paragraph num="(b)"> <text>Where installed over food storage, preparation, or serving areas, food is protected by one or more of the following:</text> <paragraph num="(i)"> <text>Pipe joining methods that will preclude leakage;</text> </paragraph> <paragraph num="(ii)"> <text>Using wall-mounted fixtures;</text> </paragraph> <paragraph num="(iii)"> <text>Limiting the number of pipe joints;</text> </paragraph> <paragraph num="(iv)"> <text>Pressure testing the piping;</text> </paragraph> <paragraph num="(v)"> <text>Thermally insulating pipes to prevent condensation; and</text> </paragraph> <paragraph num="(vi)"> <text>Installing integral seepage pans or pipe sleeves;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Toilet facilities are:</text> <paragraph num="(1)"> <text>Sufficient in number to serve the facility;</text> </paragraph> <paragraph num="(2)"> <text>Conveniently located;</text> </paragraph> <paragraph num="(3)"> <text>Accessible to employees at all times;</text> </paragraph> <paragraph num="(4)"> <text>Except as specified in Health-General Article, §21-325(b), Annotated Code of Maryland, for facilities established after January 1, 1979, provided for patrons whenever a food service facility:</text> <paragraph num="(a)"> <text>Prepares food and provides seating; or</text> </paragraph> <paragraph num="(b)"> <text>Is a carry-out facility with indoor tables used for dining;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Installed in accordance with applicable State and local laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(6)"> <text>Designed with fixtures that are:</text> <paragraph num="(a)"> <text>Of sanitary design; and</text> </paragraph> <paragraph num="(b)"> <text>Readily cleanable;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Kept:</text> <paragraph num="(a)"> <text>Clean;</text> </paragraph> <paragraph num="(b)"> <text>In good repair; and</text> </paragraph> <paragraph num="(c)"> <text>Free of objectionable odor; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Supplied with:</text> <paragraph num="(a)"> <text>Toilet tissue at each toilet at all times; and</text> </paragraph> <paragraph num="(b)"> <text>Receptacles that are easily cleanable and covered for waste materials in toilet rooms for women;</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Toilet rooms:</text> <paragraph num="(1)"> <text>Are completely enclosed;</text> </paragraph> <paragraph num="(2)"> <text>Are equipped with self-closing doors except when a toilet room without doors is approved by the approving authority based on a review that shows that:</text> <paragraph num="(a)"> <text>Doors would impede the use of the toilet room; and</text> </paragraph> <paragraph num="(b)"> <text>The requirements in §J(3)—(6) of this regulation are met;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide privacy;</text> </paragraph> <paragraph num="(4)"> <text>Are provided mechanical ventilation that:</text> <paragraph num="(a)"> <text>Exhausts air at the rate of 2 cubic feet per minute per square foot of floor area; and</text> </paragraph> <paragraph num="(b)"> <text>Allows the entrance of an equal amount of makeup air;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Prevent the entry of insects and vermin; and</text> </paragraph> <paragraph num="(6)"> <text>Do not open directly into the kitchen or food preparation areas;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Hand washing facilities are:</text> <paragraph num="(1)"> <text>Located:</text> <paragraph num="(a)"> <text>In each food preparation and processing area;</text> </paragraph> <paragraph num="(b)"> <text>In each utensil washing area; and</text> </paragraph> <paragraph num="(c)"> <text>Adjacent to all toilet rooms;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Accessible at all times;</text> </paragraph> <paragraph num="(3)"> <text>Equipped with an adequate supply of hand-cleaning soap or detergent;</text> </paragraph> <paragraph num="(4)"> <text>Equipped with a means of drying hands, such as:</text> <paragraph num="(a)"> <text>Individual towels in dispensers; or</text> </paragraph> <paragraph num="(b)"> <text>An effective hand-drying device;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Equipped with a waste receptacle; and</text> </paragraph> <paragraph num="(6)"> <text>Kept clean and in good repair;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Hand sinks are:</text> <paragraph num="(1)"> <text>Installed in accordance with applicable State and local laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Able to discharge:</text> <paragraph num="(a)"> <text>Hot and cold running water; or</text> </paragraph> <paragraph num="(b)"> <text>Tempered running water at a temperature of at least 100°F through:</text> <paragraph num="(i)"> <text>A mixing valve;</text> </paragraph> <paragraph num="(ii)"> <text>A combination faucet; or</text> </paragraph> <paragraph num="(iii)"> <text>Any slow closing or metering faucet that provides a flow of water for at least 15 seconds before the faucet has to be reactivated; and</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Utensil washing vats, food preparation sinks, or mop sinks are not used as hand sinks.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Garbage and Rubbish Disposal."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Garbage is stored in the following ways as applicable to the facility:</text> <paragraph num="(1)"> <text>In containers that:</text> <paragraph num="(a)"> <text>Are sufficient in number to hold all of the garbage that accumulates between periods of removal from the premises;</text> </paragraph> <paragraph num="(b)"> <text>Do not leak or absorb liquids;</text> </paragraph> <paragraph num="(c)"> <text>Are constructed of durable metal or another approved type of material; and</text> </paragraph> <paragraph num="(d)"> <text>Are provided with tight-fitting lids or covers unless kept in a:</text> <paragraph num="(i)"> <text>Vermin-proofed room or enclosure; or</text> </paragraph> <paragraph num="(ii)"> <text>Waste refrigerator;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In storage areas that:</text> <paragraph num="(a)"> <text>Are clean; and</text> </paragraph> <paragraph num="(b)"> <text>Do not constitute a nuisance;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In storage rooms or enclosures that:</text> <paragraph num="(a)"> <text>Are constructed of easily cleanable, grease resistant, washable materials; and</text> </paragraph> <paragraph num="(b)"> <text>Are vermin-proofed;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In garbage containers outside the establishment that are located on a grease resistant, durable surface; and</text> </paragraph> <paragraph num="(5)"> <text>For damaged, adulterated, or recalled products, in designated areas separate from:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Equipment;</text> </paragraph> <paragraph num="(c)"> <text>Utensils;</text> </paragraph> <paragraph num="(d)"> <text>Linens; and</text> </paragraph> <paragraph num="(e)"> <text>Single service and single use articles that are held for credit, redemption, or return to the distributor;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Garbage containers are cleaned as necessary to prevent a buildup of soil:</text> <paragraph num="(1)"> <text>In a manner that does not contaminate food, equipment, utensils, or food preparation areas;</text> </paragraph> <paragraph num="(2)"> <text>With:</text> <paragraph num="(a)"> <text>Brushes for washing that may not be used for any other purpose;</text> </paragraph> <paragraph num="(b)"> <text>Can-washing machines;</text> </paragraph> <paragraph num="(c)"> <text>Steam-cleaning devices; or</text> </paragraph> <paragraph num="(d)"> <text>Similar equipment; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In an area that enables waste water from cleaning operations to be disposed of as sewage;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Food waste grinders are:</text> <paragraph num="(1)"> <text>Constructed and installed to comply with applicable State and local plumbing laws, ordinances, and regulations; and</text> </paragraph> <paragraph num="(2)"> <text>Not connected to a sink drain that is used for food or utensils;</text> </paragraph> </paragraph> <paragraph num="D."> <text>All garbage and rubbish is disposed of:</text> <paragraph num="(1)"> <text>Daily, or as often as necessary, to prevent a nuisance or insanitary condition; and</text> </paragraph> <paragraph num="(2)"> <text>By a method that complies with applicable State and local laws, regulations, and ordinances; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>Used cooking grease and oils are stored, recycled, and disposed of in accordance with applicable State and local laws, regulations, and ordinances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Vermin Control."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>A food service facility may operate with its outer doors and windows open unless, while the food service facility is operating with the outer doors or outer windows open, the approving authority:</text> <paragraph num="(1)"> <text>Finds evidence of vermin in food preparation or food storage areas; or</text> </paragraph> <paragraph num="(2)"> <text>Finds evidence of flying insects in food preparation or food storage areas that pose a significant threat to sanitation or public health.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the food service facility shall take immediate action to eliminate the vermin or flying insects.</text> </paragraph> <paragraph num="C."> <text>If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the approving authority may:</text> <paragraph num="(1)"> <text>Close a food service facility;</text> </paragraph> <paragraph num="(2)"> <text>Order a temporary closure of the outer windows and outer doors, until the vermin or flying insects are eliminated from the food preparation or food storage areas; or</text> </paragraph> <paragraph num="(3)"> <text>Take another action to eliminate vermin or flying insects.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A food service facility found to be operating in violation of §A of this regulation on three or more separate occasions shall keep the outer windows and outer doors closed at all times until:</text> <paragraph num="(1)"> <text>Modifications approved by the local approving authority are made to the food service facility to effectively protect against the entrance of vermin and flying insects; or</text> </paragraph> <paragraph num="(2)"> <text>Another action acceptable by the approval authority is taken.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Effective control measures are used to eliminate rodents, flies, roaches, and other vermin from the building;</text> </paragraph> <paragraph num="(2)"> <text>The premises are kept clean and free of debris that will promote the harborage of vermin;</text> </paragraph> <paragraph num="(3)"> <text>Openings into the building are effectively protected against the entrance of insects and rodents by:</text> <paragraph num="(a)"> <text>Doors that are:</text> <paragraph num="(i)"> <text>Tight; and</text> </paragraph> <paragraph num="(ii)"> <text>Self-closing;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Screening on windows, doors, skylights, transoms, and other openings, which is:</text> <paragraph num="(i)"> <text>Tight-fitting;</text> </paragraph> <paragraph num="(ii)"> <text>In good repair; and</text> </paragraph> <paragraph num="(iii)"> <text>Made of material that is not less than 16-mesh to the inch or equivalent;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Positive air pressure or controlled air currents; and</text> </paragraph> <paragraph num="(d)"> <text>Other means acceptable to the approving authority; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Insect control devices that are used to electrocute or stun flying insects are:</text> <paragraph num="(a)"> <text>Designed to retain the insects within the device;</text> </paragraph> <paragraph num="(b)"> <text>Not located over areas used to prepare food; and</text> </paragraph> <paragraph num="(c)"> <text>Located so that dead insects and insect fragments are prevented from being impelled or from falling onto:</text> <paragraph num="(i)"> <text>Exposed food;</text> </paragraph> <paragraph num="(ii)"> <text>Clean equipment;</text> </paragraph> <paragraph num="(iii)"> <text>Utensils;</text> </paragraph> <paragraph num="(iv)"> <text>Linens; and</text> </paragraph> <paragraph num="(v)"> <text>Unwrapped single service and single use articles.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Building — Floors, Walls, and Ceilings."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>A floor and floor covering is kept:</text> <paragraph num="(1)"> <text>Clean; and</text> </paragraph> <paragraph num="(2)"> <text>In good repair;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The floor in a food preparation, food processing, food storage, utensil washing, dressing or locker, toilet, and walk-in refrigerator room or area is constructed of epoxy, sealed concrete, quarry tile, ceramic tile, commercial grade continuous sheet vinyl, or similar material that makes the floor:</text> <paragraph num="(1)"> <text>Smooth;</text> </paragraph> <paragraph num="(2)"> <text>Durable;</text> </paragraph> <paragraph num="(3)"> <text>Nonabsorbent, unless the floor is in a:</text> <paragraph num="(a)"> <text>Dry-food storage area;</text> </paragraph> <paragraph num="(b)"> <text>Dining area; or</text> </paragraph> <paragraph num="(c)"> <text>Mechanical or electrical room;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(5)"> <text>Grease resistant in areas subject to grease spillage or drippage;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A floor installed in a food preparation, food processing, food storage, utensil washing, walk-in refrigerator, dressing or locker, and toilet room or area has a juncture between the floor and the wall that is:</text> <paragraph num="(1)"> <text>Coved; and</text> </paragraph> <paragraph num="(2)"> <text>Closed;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A mat, floor covering, and duckboard is:</text> <paragraph num="(1)"> <text>Removable;</text> </paragraph> <paragraph num="(2)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(3)"> <text>Kept clean;</text> </paragraph> </paragraph> <paragraph num="E."> <text>When carpeting is used, the carpeting is placed only on the floors of:</text> <paragraph num="(1)"> <text>Interior dining areas;</text> </paragraph> <paragraph num="(2)"> <text>Retail areas where liquid products are not displayed; and</text> </paragraph> <paragraph num="(3)"> <text>Areas not subject to water flushing, spraying, or drippage;</text> </paragraph> </paragraph> <paragraph num="F."> <text>When a floor receives water as a result of processing or cleaning, floor drains are provided at a minimum of one floor drain per 400 square feet of floor area;</text> </paragraph> <paragraph num="G."> <text>When floor drains are installed, floors are graded at not less than 1/8 inch per foot to direct wastewater to the floor drains;</text> </paragraph> <paragraph num="H."> <text>A floor in a room without floor drains that requires the removal of processing or wash-water, is drained by:</text> <paragraph num="(1)"> <text>Sloping the floor at least 1/8 inch per foot toward a doorway or another opening; and</text> </paragraph> <paragraph num="(2)"> <text>Directing the wastewater into a floor drain or other discharge point located outside the room in compliance with applicable State and local laws, regulations, and ordinances;</text> </paragraph> </paragraph> <paragraph num="I."> <text>The walking and driving surfaces of all exterior areas of food service facilities are:</text> <paragraph num="(1)"> <text>Kept clean and free of debris; and</text> </paragraph> <paragraph num="(2)"> <text>Surfaced with concrete, asphalt, gravel, or similar material to facilitate maintenance and minimize dusty or muddy conditions;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A door on the building's exterior is equipped with a self-closing device;</text> </paragraph> <paragraph num="K."> <text>A wall, ceiling, door, window, skylight, and similar closure, is kept:</text> <paragraph num="(1)"> <text>Clean; and</text> </paragraph> <paragraph num="(2)"> <text>In good repair;</text> </paragraph> </paragraph> <paragraph num="L."> <text>The walls up to at least the highest level reached by splash or spray in all food preparation, food storage, utensil washing, and toilet rooms or areas have surfaces that are:</text> <paragraph num="(1)"> <text>Smooth;</text> </paragraph> <paragraph num="(2)"> <text>Washable; and</text> </paragraph> <paragraph num="(3)"> <text>Water and grease resistant;</text> </paragraph> </paragraph> <paragraph num="M."> <text>A wall covering material, such as tile, stainless steel, fiber reinforced plastic, sealed gypsum board, or a similar material, is attached and sealed to the wall or ceiling so that:</text> <paragraph num="(1)"> <text>There are no open spaces or cracks to permit accumulation of grease or soil;</text> </paragraph> <paragraph num="(2)"> <text>The surface is easily cleanable; and</text> </paragraph> <paragraph num="(3)"> <text>Harborage for vermin is prevented;</text> </paragraph> </paragraph> <paragraph num="N."> <text>Ceiling covering materials in food preparation and utensil washing areas:</text> <paragraph num="(1)"> <text>Have smooth, washable surfaces; and</text> </paragraph> <paragraph num="(2)"> <text>Do not contain fiberglass backing;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Exposed construction, such as exposed floor and ceiling rafters, trusses or beams, utility ducts, and lighting, is:</text> <paragraph num="(1)"> <text>Used only in:</text> <paragraph num="(a)"> <text>A dry food storage area;</text> </paragraph> <paragraph num="(b)"> <text>A dining area; or</text> </paragraph> <paragraph num="(c)"> <text>Other areas with the approval of the approving authority based on applicable State and local laws, regulations, and ordinances;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Not used in:</text> <paragraph num="(a)"> <text>A refrigerated food storage area;</text> </paragraph> <paragraph num="(b)"> <text>A food preparation area;</text> </paragraph> <paragraph num="(c)"> <text>An equipment and utensil washing area; and</text> </paragraph> <paragraph num="(d)"> <text>A toilet room; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Cleanable; and</text> </paragraph> </paragraph> <paragraph num="P."> <text>Piping, conduit, and similar construction located outside a wall is installed so that there is a minimum of 3/4 inch space between the piping, conduit, and similar construction and the wall.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Building — Lighting and Ventilation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Light fixtures, decorative material, and similar equipment and material attached to walls or ceilings are kept clean;</text> </paragraph> <paragraph num="B."> <text>Lighting provides artificial light at:</text> <paragraph num="(1)"> <text>50 footcandles at a surface where a food employee is working with food, utensils, or equipment;</text> </paragraph> <paragraph num="(2)"> <text>20 footcandles at 30 inches from the floor in a:</text> <paragraph num="(a)"> <text>Storage area;</text> </paragraph> <paragraph num="(b)"> <text>Toilet room;</text> </paragraph> <paragraph num="(c)"> <text>Locker room;</text> </paragraph> <paragraph num="(d)"> <text>Garbage and rubbish storage area;</text> </paragraph> <paragraph num="(e)"> <text>Dining area during cleaning;</text> </paragraph> <paragraph num="(f)"> <text>Utensil washing area;</text> </paragraph> <paragraph num="(g)"> <text>Bar;</text> </paragraph> <paragraph num="(h)"> <text>Wait station; and</text> </paragraph> <paragraph num="(i)"> <text>Service area; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Another lighting level approved by the approving authority based on a review that indicates the lighting level is sufficient for cleaning, facility maintenance, and employee safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Light bulbs and tubes are shielded to prevent broken glass from falling onto food and utensils;</text> </paragraph> <paragraph num="D."> <text>Infrared or other heat lamps are protected against breakage by a shield surrounding and extending beyond the bulb, leaving only the face of the bulb exposed;</text> </paragraph> <paragraph num="E."> <text>The facility is ventilated with ventilation equipment that is maintained and operated so that:</text> <paragraph num="(1)"> <text>All areas are kept reasonably free from:</text> <paragraph num="(a)"> <text>Excessive heat;</text> </paragraph> <paragraph num="(b)"> <text>Steam;</text> </paragraph> <paragraph num="(c)"> <text>Condensation;</text> </paragraph> <paragraph num="(d)"> <text>Vapors;</text> </paragraph> <paragraph num="(e)"> <text>Smoke; and</text> </paragraph> <paragraph num="(f)"> <text>Fumes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Outside air is supplied:</text> <paragraph num="(a)"> <text>Through:</text> <paragraph num="(i)"> <text>The HVAC system;</text> </paragraph> <paragraph num="(ii)"> <text>A separate supply fan; or</text> </paragraph> <paragraph num="(iii)"> <text>A combination of the HVAC system and a separate supply fan;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>So that the entry of outdoor contaminants is excluded by:</text> <paragraph num="(i)"> <text>Maintaining the building under a slight positive pressure; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an air filtering system; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>So that it does not reduce the effectiveness of the exhaust system;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Mechanical exhaust and make-up air systems are connected by an interlocking switch in order to provide make-up air whenever the exhaust system is in operation; and</text> </paragraph> <paragraph num="(4)"> <text>Make-up air is tempered when necessary to:</text> <paragraph num="(a)"> <text>Prevent the build-up of condensation that could:</text> <paragraph num="(i)"> <text>Result in an unsanitary condition within the facility; and</text> </paragraph> <paragraph num="(ii)"> <text>Contaminate food;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide comfortable working conditions; and</text> </paragraph> <paragraph num="(c)"> <text>Comply with applicable building codes;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Rooms, areas, and equipment from which aerosols, odors, fumes, or vapors may originate are effectively vented to the outside air by a system that does not create a harmful or unlawful discharge;</text> </paragraph> <paragraph num="G."> <text>A ventilation hood or other ventilation device or fixture is designed:</text> <paragraph num="(1)"> <text>To prevent grease or condensate from dripping onto food or onto food preparation surfaces;</text> </paragraph> <paragraph num="(2)"> <text>In compliance with NSF Standard 2; and</text> </paragraph> <paragraph num="(3)"> <text>So that interior and exterior parts are easily accessible for maintenance and cleaning;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Intake air ducts are designed and maintained to prevent the entrance of:</text> <paragraph num="(1)"> <text>Dust;</text> </paragraph> <paragraph num="(2)"> <text>Dirt;</text> </paragraph> <paragraph num="(3)"> <text>Insects; or</text> </paragraph> <paragraph num="(4)"> <text>Other contaminating materials;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A grease removing exhaust hood is provided when needed over commercial cooking equipment that produces grease-laden vapors or smoke, such as:</text> <paragraph num="(1)"> <text>Griddles;</text> </paragraph> <paragraph num="(2)"> <text>Fryers;</text> </paragraph> <paragraph num="(3)"> <text>Charbroilers;</text> </paragraph> <paragraph num="(4)"> <text>Ovens used to cook fatty foods at a temperature which exceeds the vaporization point of grease; and</text> </paragraph> <paragraph num="(5)"> <text>Solid fuel cooking equipment;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A ventilation hood is provided over equipment where needed, for heat, fumes, and steam removal, including:</text> <paragraph num="(1)"> <text>High temperature ovens not cooking fatty foods or not emitting grease vapors;</text> </paragraph> <paragraph num="(2)"> <text>Steam kettles; and</text> </paragraph> <paragraph num="(3)"> <text>Warewashing machines using hot water sanitization;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Overshelves are used over cooking equipment under a hood only if:</text> <paragraph num="(1)"> <text>Deflectors or the design of the overshelf prevents grease from condensing on the bottom of the overshelf and contaminating the food below;</text> </paragraph> <paragraph num="(2)"> <text>Deflectors meet NSF or equivalent standards for food zone materials; and</text> </paragraph> <paragraph num="(3)"> <text>The ability of the hood to capture grease vapors and smoke is not impaired;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Equipment is not added or substituted under a hood that exceeds the capacity of the hood to remove:</text> <paragraph num="(1)"> <text>Heat;</text> </paragraph> <paragraph num="(2)"> <text>Steam;</text> </paragraph> <paragraph num="(3)"> <text>Smoke;</text> </paragraph> <paragraph num="(4)"> <text>Grease;</text> </paragraph> <paragraph num="(5)"> <text>Fumes; and</text> </paragraph> <paragraph num="(6)"> <text>Obnoxious odors;</text> </paragraph> </paragraph> <paragraph num="M."> <text>Except as provided in §N of this regulation, ventilation in toilet rooms is provided:</text> <paragraph num="(1)"> <text>So that 2 cubic feet of air per minute per square foot of floor space is mechanically exhausted to the outside; and</text> </paragraph> <paragraph num="(2)"> <text>With make-up air;</text> </paragraph> </paragraph> <paragraph num="N."> <text>When an existing building is converted for use as a food service facility and there is no feasible method to vent the toilet room to the exterior of the building, a ductless exhaust fan is used that:</text> <paragraph num="(1)"> <text>Is sized and installed so that it will move 2 cubic feet of air per minute per square foot of floor area; and</text> </paragraph> <paragraph num="(2)"> <text>Is serviced and maintained according to the manufacturer's specifications; and</text> </paragraph> </paragraph> <paragraph num="O."> <text>Required ventilation meets the provisions of this regulation:</text> <paragraph num="(1)"> <text>Initially; and</text> </paragraph> <paragraph num="(2)"> <text>For the life of the system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Building — Cleanliness and Operations."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>The facility and parts of the property associated with the operation of the facility are kept:</text> <paragraph num="(a)"> <text>Clean; and</text> </paragraph> <paragraph num="(b)"> <text>Free of litter and rubbish;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Traffic through the food operation and utensil washing areas is limited to on-duty personnel conducting pertinent job-related functions;</text> </paragraph> <paragraph num="(3)"> <text>The facility is not used for living or sleeping quarters;</text> </paragraph> <paragraph num="(4)"> <text>Sufficient space to store all custodial equipment is provided;</text> </paragraph> <paragraph num="(5)"> <text>At least one utility sink or curbed cleaning facility with a floor drain is provided and used for:</text> <paragraph num="(a)"> <text>Cleaning mops or similar wet floor cleaning tools; and</text> </paragraph> <paragraph num="(b)"> <text>The disposal of mop water or similar liquid wastes;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A hand sink, utensil washing, equipment washing, or food preparation sink is not used as a mop or utility sink;</text> </paragraph> <paragraph num="(7)"> <text>Except for emergency cleaning due to an accident or spill, all cleaning is done during periods when the least amount of food is exposed, such as after closing to the public;</text> </paragraph> <paragraph num="(8)"> <text>Cleaning and sanitizing occur in a manner that protects food from contamination;</text> </paragraph> <paragraph num="(9)"> <text>Vacuum cleaning, wet cleaning, other dustless methods of floor and wall cleaning, or dust-arresting sweeping compounds and brooms are used in a manner that:</text> <paragraph num="(a)"> <text>Removes dust and soils; and</text> </paragraph> <paragraph num="(b)"> <text>Prevents the contamination of food and food-contact surfaces;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Linens and clothes are stored:</text> <paragraph num="(a)"> <text>Laundered and in a clean place until used; and</text> </paragraph> <paragraph num="(b)"> <text>In non-absorbent containers or laundry bags when damp or soiled until removed for laundering;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Employee clothing and personal belongings are stored in:</text> <paragraph num="(a)"> <text>Dressing rooms or dedicated areas that are:</text> <paragraph num="(i)"> <text>Provided when employees change clothing within the facility;</text> </paragraph> <paragraph num="(ii)"> <text>Located outside of food preparation, serving, and utensil washing areas; and</text> </paragraph> <paragraph num="(iii)"> <text>Kept clean; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Lockers or other facilities within dressing rooms or areas; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Live birds and animals are not present on the premises of a food service facility except for:</text> <paragraph num="(a)"> <text>Edible fish, shellfish, crustacea, or decorative fish in aquariums or display tank systems;</text> </paragraph> <paragraph num="(b)"> <text>Service animals that are controlled by the individual with a disability;</text> </paragraph> <paragraph num="(c)"> <text>Pets in the common dining areas of health care facilities at times other than during meals if:</text> <paragraph num="(i)"> <text>Effective partitioning and self-closing doors separate the common dining areas from food storage and food preparation areas;</text> </paragraph> <paragraph num="(ii)"> <text>Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining area when pets are present; and</text> </paragraph> <paragraph num="(iii)"> <text>Dining areas including tables and countertops are cleaned and sanitized before the next meal service; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A patron’s dog in an outdoor dining area of a food service facility in conformance with applicable State and local laws, ordinances, and regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Patrons' Dogs in Outdoor Dining Areas.</text> <paragraph num="(1)"> <text>Subject to the requirements of §§B(2)—(5) of this regulation, an owner of a restaurant may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the restaurant.</text> </paragraph> <paragraph num="(2)"> <text>Before an owner may allow a patron's dog to accompany the patron in the outdoor dining area, the owner shall:</text> <paragraph num="(a)"> <text>Provide written notice to the approving authority or the local health department in the jurisdiction where the restaurant is located that the owner intends to allow patrons' dogs to accompany patrons in the outdoor dining area of the restaurant 30 days prior to the days dogs will be allowed; and</text> </paragraph> <paragraph num="(b)"> <text>Place on permanent display in the restaurant a written notice that:</text> <paragraph num="(i)"> <text>States the restaurant's policy of allowing patrons' dogs in an outdoor dining area;</text> </paragraph> <paragraph num="(ii)"> <text>Is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet; and</text> </paragraph> <paragraph num="(iii)"> <text>Is in a location that is plainly visible to the patrons of the restaurant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>In establishing the restaurant's policy concerning patron's dogs in outdoor dining areas, the owner may:</text> <paragraph num="(a)"> <text>Determine the location and the amount of space designated for a patron accompanied by the patron's dog; and</text> </paragraph> <paragraph num="(b)"> <text>Establish a limit on the size and type of dogs and any other limitations relating to a patron's dog.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At the owner's discretion, the owner may deny entry to the restaurant or eject from the restaurant any patron and the patron's dog.</text> </paragraph> <paragraph num="(5)"> <text>A patron accompanied by a dog:</text> <paragraph num="(a)"> <text>Shall:</text> <paragraph num="(i)"> <text>Be an adult who is responsible for the behavior of the dog;</text> </paragraph> <paragraph num="(ii)"> <text>Keep the dog with the patron on a leash at all times at the table at which the patron is seated; and</text> </paragraph> <paragraph num="(iii)"> <text>Be liable for any damages caused by the dog to the restaurant or any other patron of the restaurant; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May not:</text> <paragraph num="(i)"> <text>Allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; or</text> </paragraph> <paragraph num="(ii)"> <text>Leave the dog unattended at any time.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Food Manufacturing in Food Service Facilities."> <paragraph num="A."> <text>A person who is licensed to operate a food service facility may manufacture food for sale or distribution as provided in §§B, C, and E of this regulation.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that before a food is manufactured in a food service facility:</text> <paragraph num="(1)"> <text>Plans for the manufacturing:</text> <paragraph num="(a)"> <text>Are submitted to the Department;</text> </paragraph> <paragraph num="(b)"> <text>Are approved in writing by the Department based on a review that indicates compliance with this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Include:</text> <paragraph num="(i)"> <text>A list of foods proposed for manufacture;</text> </paragraph> <paragraph num="(ii)"> <text>The proposed processing procedures for a food;</text> </paragraph> <paragraph num="(iii)"> <text>Specifications for equipment items to be used for manufacture;</text> </paragraph> <paragraph num="(iv)"> <text>Packaging and labeling information;</text> </paragraph> <paragraph num="(v)"> <text>Methods of shipment;</text> </paragraph> <paragraph num="(vi)"> <text>Procedures for maintaining potentially hazardous food as set forth in Regulation .06B(7)—(13) of this chapter; and</text> </paragraph> <paragraph num="(vii)"> <text>An HACCP plan in accordance with Regulation .34 of this chapter; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The facilities and equipment proposed for use in manufacturing are:</text> <paragraph num="(a)"> <text>Inspected by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Approved in writing by the Department based on a review that indicates compliance with this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A person licensed only to operate a food service facility may not manufacture the following foods:</text> <paragraph num="(1)"> <text>Low-acid canned foods as defined in 21 CFR §113.3(n);</text> </paragraph> <paragraph num="(2)"> <text>Acidified foods as defined in 21 CFR §114.3(b);</text> </paragraph> <paragraph num="(3)"> <text>Hermetically sealed and ready-to-eat potentially hazardous foods that a hazard analysis indicates are associated with the outgrowth of Clostridium botulinum or Listeria monocytogenes, such as:</text> <paragraph num="(a)"> <text>Smoked fish; or</text> </paragraph> <paragraph num="(b)"> <text>Pasteurized crabmeat;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Bottled water; or</text> </paragraph> <paragraph num="(5)"> <text>Soft drinks.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The approving authority shall routinely inspect the food manufacturing conducted in the food service facility:</text> <paragraph num="(1)"> <text>During inspections of the retail food service facility; and</text> </paragraph> <paragraph num="(2)"> <text>At a frequency set forth in Regulation .30 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>All manufactured food is labeled in accordance with Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Records are:</text> <paragraph num="(a)"> <text>Made to allow the trace-back of distributed or sold food to the food service facility that manufactured the food;</text> </paragraph> <paragraph num="(b)"> <text>Made to identify the immediate source of the food and food ingredients stored and processed at the facility;</text> </paragraph> <paragraph num="(c)"> <text>For shell eggs, made to provide the information required in COMAR 15.04.01.03A(2)(a)—(e);</text> </paragraph> <paragraph num="(d)"> <text>Made to identify the initial distribution of the food to facilitate the segregation of food that may have become adulterated or otherwise unfit for human consumption; and</text> </paragraph> <paragraph num="(e)"> <text>Maintained at the facility for at least:</text> <paragraph num="(i)"> <text>2 years for a shelf stable or preserved food; and</text> </paragraph> <paragraph num="(ii)"> <text>1 year for a fresh food.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Special Food Service Facilities."> <paragraph num="A."> <text>For a special food service facility that handles only potentially hazardous food that remains in the original container or wrapping and that does not prepare, wrap, or package the food at the facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.23, .25, .28—.33, and .35—.39 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>When single service articles are used, the single service articles comply with Regulation .17H of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For a special food service facility that handles food that is removed from the original package or that prepares, packages, or wraps food at the facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.25, and .28—.39 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The premises are kept clean and free of litter or rubbish;</text> </paragraph> <paragraph num="(3)"> <text>If permanent toilet facilities are not required, temporary toilet facilities are made available and maintained in a sanitary manner;</text> </paragraph> <paragraph num="(4)"> <text>Except as provided in §D(2) of this regulation, adequate hand washing facilities are provided by:</text> <paragraph num="(a)"> <text>Where potable water under pressure is available, a hand sink as set forth in Regulation .18K and L of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Another hand washing facility that has:</text> <paragraph num="(i)"> <text>Warm water;</text> </paragraph> <paragraph num="(ii)"> <text>Soap; and</text> </paragraph> <paragraph num="(iii)"> <text>Paper towels; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Wastewater from hand washing, food preparation, and cleaning is disposed of in accordance with State and local laws, regulations, and ordinances.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For a special food service facility that is a mobile unit, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with either §A or B of this regulation as applicable;</text> </paragraph> <paragraph num="(2)"> <text>Equipment components of the mobile unit are in compliance with Regulation .15A(1) and (2) or B of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>A hand washing sink is provided as set forth in Regulation .18K and L of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Potable water tanks are used to provide water for hand washing and, where applicable, for food preparation and utensil cleaning;</text> </paragraph> <paragraph num="(5)"> <text>Wastewater tanks are used to hold wastewater pending disposal at a facility in a manner that conforms with State and local laws, regulations, and ordinances;</text> </paragraph> <paragraph num="(6)"> <text>Subject to §C(8) and (9) of this regulation, a base of operations is established that provides:</text> <paragraph num="(a)"> <text>A source of potable water, potable water hoses, and clean connections;</text> </paragraph> <paragraph num="(b)"> <text>A method for the disposal of sewage;</text> </paragraph> <paragraph num="(c)"> <text>Clean, adequate, and covered trash receptacles;</text> </paragraph> <paragraph num="(d)"> <text>A storage area for single serve food items; and</text> </paragraph> <paragraph num="(e)"> <text>If necessary:</text> <paragraph num="(i)"> <text>Refrigerated and dry food storage areas; and</text> </paragraph> <paragraph num="(ii)"> <text>A utensil washing facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>The base of operation is located within 90 miles of the licensing county;</text> </paragraph> <paragraph num="(8)"> <text>For a mobile food service facility not seeking a mobile reciprocity license, a base of operations as set forth in §C(6) and (7) of this regulation is established by May 1, 2020;</text> </paragraph> <paragraph num="(9)"> <text>A base of operations is not required for a mobile food service facility that offers only prepackaged frozen desserts;</text> </paragraph> <paragraph num="(10)"> <text>A valid license from the county of origin is maintained; and</text> </paragraph> <paragraph num="(11)"> <text>Compliance is maintained with all applicable State and local laws and regulations in the jurisdiction in which it is operating.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For a special food service facility that is a temporary food service facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required;</text> </paragraph> <paragraph num="(2)"> <text>Where potable water under pressure is not available, sufficient containerized potable water is provided for:</text> <paragraph num="(a)"> <text>Hand washing; and</text> </paragraph> <paragraph num="(b)"> <text>Rinsing utensils; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The period of time that the facility operates is limited to the time stated in Regulation .02B(80) of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>For a special food service that is a bed and breakfast, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with either §A or B of this regulation as applicable;</text> </paragraph> <paragraph num="(2)"> <text>The facility serves hot meals only to renters; and</text> </paragraph> <paragraph num="(3)"> <text>The facility does not operate as a restaurant or caterer.</text> </paragraph> </paragraph> <paragraph num="F."> <text>For a special food service facility that is a semi-permanent food service facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with either §A or B of this chapter as applicable;</text> </paragraph> <paragraph num="(2)"> <text>A connection to potable water is maintained as a critical item, as set forth in Regulation .18A of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Hand sinks are provided and maintained as set forth in Regulation .18K and L of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>A connection to a sewage disposal system is provided and maintained as a critical item that meets applicable State and local laws, regulations, and ordinances.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For a special food service facility that is an on-farm food service facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required;</text> </paragraph> <paragraph num="(2)"> <text>Hand washing stations are provided in close proximity to the food service facility for use by customers;</text> </paragraph> <paragraph num="(3)"> <text>Signs are displayed prominently at the hand washing stations stating “In the interests of public health, please wash your hands thoroughly before entering or handling food.”; and</text> </paragraph> <paragraph num="(4)"> <text>The period of time that the facility operates is limited to the time in Regulation .02B(48) of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>For a special food service facility that is a seasonal farmer’s market producer sampling food service facility, the person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance is maintained with §B of this regulation when food is removed from the original package or food is prepared at the facility, except that no compliance with Regulations .21 and .22 of this chapter is required;</text> </paragraph> <paragraph num="(2)"> <text>Where potable water under pressure is not available, sufficient containerized potable water is provided for:</text> <paragraph num="(a)"> <text>Hand washing; and</text> </paragraph> <paragraph num="(b)"> <text>Rinsing utensils; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The period of time that the facility operates is limited to the time stated in Regulation .02B(70) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Excluded Organizations."> <paragraph num="A."> <text>Pursuant to Health-General Article, §21-304(a)(2), Annotated Code of Maryland, a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days, may make:</text> <paragraph num="(1)"> <text>A rescindable decision to operate as a licensed food service facility and in full compliance with this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>A decision to operate without a license and in compliance with §§B—E of this regulation, which establish the minimum requirements to ensure food safety at a food preparation or serving area operated by an excluded organization without a license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that a food preparation or service area operated by an excluded organization without a license complies with Regulations .01—.15A(3)—(10), .16—.23, .26—.27, and .29—.39 of this chapter.</text> </paragraph> <paragraph num="C."> <text>During the operation of a special food service facility, the person-in-charge of an unlicensed excluded organization shall ensure compliance with:</text> <paragraph num="(1)"> <text>Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.20, .22B—D, .23, .26, .29—.33, and .35—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that:</text> <paragraph num="(a)"> <text>Handles only potentially hazardous food that remains within the original container or wrapping; and</text> </paragraph> <paragraph num="(b)"> <text>Does not prepare, wrap, or package food at the facility; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.20, .22B—D, .23, .26, and .29—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that:</text> <paragraph num="(a)"> <text>Handles food that is removed from the original container or wrapping; or</text> </paragraph> <paragraph num="(b)"> <text>Prepares, packs, or wraps potentially hazardous food at the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The person-in-charge shall ensure that an unlicensed excluded organization does not:</text> <paragraph num="(1)"> <text>Operate a bed and breakfast;</text> </paragraph> <paragraph num="(2)"> <text>Operate a semi-permanent food service; or</text> </paragraph> <paragraph num="(3)"> <text>Except as provided for in §G of this regulation, perform retail food manufacturing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The person-in-charge shall ensure that, when an unlicensed excluded organization plans a single event to prepare or serve potentially hazardous food to 200 or more individuals from the public:</text> <paragraph num="(1)"> <text>Written notification of the event is submitted to the approving authority not less than 30 days before the scheduled event; and</text> </paragraph> <paragraph num="(2)"> <text>The written notification required in §E(1) of this regulation contains:</text> <paragraph num="(a)"> <text>The date, place, and time of the event;</text> </paragraph> <paragraph num="(b)"> <text>The estimated number of individuals to be served at the event;</text> </paragraph> <paragraph num="(c)"> <text>A menu or list of foods to be served;</text> </paragraph> <paragraph num="(d)"> <text>The source of all potentially hazardous foods to be served;</text> </paragraph> <paragraph num="(e)"> <text>A list of foods to be prepared more than 12 hours in advance of service;</text> </paragraph> <paragraph num="(f)"> <text>If food is to be prepared off-premises, the:</text> <paragraph num="(i)"> <text>Name of the facility to be used; and</text> </paragraph> <paragraph num="(ii)"> <text>Procedures for transporting food to the premises;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>The name, address, and telephone number of a responsible contact individual; and</text> </paragraph> <paragraph num="(h)"> <text>Any other information requested by the approving authority in order to review the food preparation and service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The person-in-charge shall ensure that when an unlicensed excluded organization plans to serve food to the public for up to 30 consecutive days, a written notice is provided to the Department that includes the:</text> <paragraph num="(1)"> <text>Dates on which the food will be prepared;</text> </paragraph> <paragraph num="(2)"> <text>Methods of storing and serving food; and</text> </paragraph> <paragraph num="(3)"> <text>Methods or procedures that will be followed to ensure food:</text> <paragraph num="(a)"> <text>Safety; and</text> </paragraph> <paragraph num="(b)"> <text>Security.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>In Carroll County, a religious organization that meets the definition of an excluded organization as set forth in Regulation .02B(28) of this chapter, and complies with COMAR 10.15.01.09A—D and .10A and 10.15.04.08, or a county-owned and county-operated park or facility that is hosting a public festival, may offer for sale directly to the public the following types of homemade style food, only if the food is produced at the kitchen of the excluded organization:</text> <paragraph num="(1)"> <text>Fruit butter made only from:</text> <paragraph num="(a)"> <text>Apples;</text> </paragraph> <paragraph num="(b)"> <text>Apricots;</text> </paragraph> <paragraph num="(c)"> <text>Grapes;</text> </paragraph> <paragraph num="(d)"> <text>Peaches;</text> </paragraph> <paragraph num="(e)"> <text>Plums; or</text> </paragraph> <paragraph num="(f)"> <text>Quince;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Jam, preserve, or jelly, made only from:</text> <paragraph num="(a)"> <text>A fruit listed in §G(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Oranges;</text> </paragraph> <paragraph num="(c)"> <text>Nectarines;</text> </paragraph> <paragraph num="(d)"> <text>Tangerines;</text> </paragraph> <paragraph num="(e)"> <text>Blackberries;</text> </paragraph> <paragraph num="(f)"> <text>Raspberries;</text> </paragraph> <paragraph num="(g)"> <text>Blueberries;</text> </paragraph> <paragraph num="(h)"> <text>Boysenberries;</text> </paragraph> <paragraph num="(i)"> <text>Cherries;</text> </paragraph> <paragraph num="(j)"> <text>Cranberries;</text> </paragraph> <paragraph num="(k)"> <text>Strawberries; or</text> </paragraph> <paragraph num="(l)"> <text>Red currants;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Fruit pies made from a fruit listed in §G(1) and (2) of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Honey.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Farmer's Market, Bake Sales, and Cottage Food Business."> <paragraph num="A."> <text>A cottage food business may offer for sale the homemade foods specified in §B of this regulation when the foods are:</text> <paragraph num="(1)"> <text>Made in a private home kitchen; and</text> </paragraph> <paragraph num="(2)"> <text>Offered or sold only in the State:</text> <paragraph num="(a)"> <text>Subject to the requirements of §C(6) and (7) of this regulation, at a retail food store; or</text> </paragraph> <paragraph num="(b)"> <text>Directly to a consumer:</text> <paragraph num="(i)"> <text>At a farmer’s market;</text> </paragraph> <paragraph num="(ii)"> <text>At a bake sale;</text> </paragraph> <paragraph num="(iii)"> <text>At a public event;</text> </paragraph> <paragraph num="(iv)"> <text>By personal delivery; or</text> </paragraph> <paragraph num="(v)"> <text>By mail order.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall allow the preparation and sale of the following foods in accordance with §A of this regulation:</text> <paragraph num="(1)"> <text>Non-potentially hazardous hot-filled canned acid fruit jellies, jams, preserves, and butters that are:</text> <paragraph num="(a)"> <text>Unadulterated;</text> </paragraph> <paragraph num="(b)"> <text>Packaged to maintain food safety and integrity; and</text> </paragraph> <paragraph num="(c)"> <text>Labeled in accordance with Regulation .12 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fruit butters made only from:</text> <paragraph num="(a)"> <text>Apples;</text> </paragraph> <paragraph num="(b)"> <text>Apricots;</text> </paragraph> <paragraph num="(c)"> <text>Grapes;</text> </paragraph> <paragraph num="(d)"> <text>Peaches;</text> </paragraph> <paragraph num="(e)"> <text>Plums;</text> </paragraph> <paragraph num="(f)"> <text>Prunes;</text> </paragraph> <paragraph num="(g)"> <text>Quince; or</text> </paragraph> <paragraph num="(h)"> <text>Another fruit or fruit mixture that will produce an acid canned food;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Jam, preserve, or jelly made only from:</text> <paragraph num="(a)"> <text>A fruit listed in §B(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Oranges;</text> </paragraph> <paragraph num="(c)"> <text>Nectarines;</text> </paragraph> <paragraph num="(d)"> <text>Tangerines;</text> </paragraph> <paragraph num="(e)"> <text>Blackberries;</text> </paragraph> <paragraph num="(f)"> <text>Raspberries;</text> </paragraph> <paragraph num="(g)"> <text>Blueberries;</text> </paragraph> <paragraph num="(h)"> <text>Boysenberries;</text> </paragraph> <paragraph num="(i)"> <text>Cherries;</text> </paragraph> <paragraph num="(j)"> <text>Cranberries;</text> </paragraph> <paragraph num="(k)"> <text>Strawberries;</text> </paragraph> <paragraph num="(l)"> <text>Red currants; or</text> </paragraph> <paragraph num="(m)"> <text>Another fruit or fruit mixture that will produce an acid canned food;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Non-potentially hazardous baked goods;</text> </paragraph> <paragraph num="(5)"> <text>Foods manufactured on a farm by a licensed food processor in accordance with COMAR 10.15.04.19;</text> </paragraph> <paragraph num="(6)"> <text>Non-potentially hazardous candy; and</text> </paragraph> <paragraph num="(7)"> <text>All other non-potentially hazardous foods produced by a licensed entity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Cottage Food Business.</text> <paragraph num="(1)"> <text>The Department shall allow the owner of a cottage food business to sell only cottage food products processed and packaged in Maryland that are:</text> <paragraph num="(a)"> <text>Produced or packaged in a residential kitchen;</text> </paragraph> <paragraph num="(b)"> <text>Stored on the premises of the cottage food business; and</text> </paragraph> <paragraph num="(c)"> <text>Prepackaged with a label that contains the following information:</text> <paragraph num="(i)"> <text>The name and address of the cottage food business or the name, phone number, and identification number assigned to the cottage food business by the Department;</text> </paragraph> <paragraph num="(ii)"> <text>The name of the cottage food product;</text> </paragraph> <paragraph num="(iii)"> <text>The ingredients of the cottage food product in descending order of the amount of each ingredient by weight;</text> </paragraph> <paragraph num="(iv)"> <text>The net weight or net volume of the cottage food product;</text> </paragraph> <paragraph num="(v)"> <text>Allergen information as specified by federal labeling requirements;</text> </paragraph> <paragraph num="(vi)"> <text>Nutritional information as specified by federal labeling requirements, if any nutritional information claim is made;</text> </paragraph> <paragraph num="(vii)"> <text>Printed in 10 point or larger type in a color that provides a clear contrast to the background of the label: “Made by a cottage food business that is not subject to Maryland’s food safety regulations.”; and</text> </paragraph> <paragraph num="(viii)"> <text>For a cottage food product offered for sale at a retail food store, the phone number and email address of the cottage food business and the date the cottage food product was made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A cottage food business may request a unique identification number from the Department which can be used in lieu of the address of the cottage food business on the product label required under §C(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The owner of a cottage food business shall comply with all applicable county and municipal laws and ordinances regulating the preparation, processing, storage, and sale of cottage food products.</text> </paragraph> <paragraph num="(4)"> <text>Upon receipt of a complaint or outbreak of illness the Department may:</text> <paragraph num="(a)"> <text>Investigate the conditions under which the product was produced and any complaint alleging that a cottage food business has violated this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Send a representative of the Department, at a reasonable time, to enter and inspect the premises of a cottage food business to determine compliance with this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Collect samples of a cottage food product or its ingredients to determine if the cottage food product is misbranded or adulterated.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The owner of a cottage food business may not:</text> <paragraph num="(a)"> <text>Refuse to grant access to a representative who requests to enter and inspect the premises of the cottage food business in response to a complaint; or</text> </paragraph> <paragraph num="(b)"> <text>Interfere with any inspection or collection of samples in response to a complaint or outbreak of illness.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Before the owner of a cottage food business may sell a cottage food product to a retail food store, the owner shall submit to the Department for review:</text> <paragraph num="(a)"> <text>The label that will be affixed to the cottage food product in accordance with §C(1)(c) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation of the owner’s successful completion of a food safety course in the past 3 years that is approved by the Department and the American National Standards Institute and includes, at a minimum, the following subjects:</text> <paragraph num="(i)"> <text>Basic food safety;</text> </paragraph> <paragraph num="(ii)"> <text>Cleaning and sanitizing;</text> </paragraph> <paragraph num="(iii)"> <text>Personal hygiene;</text> </paragraph> <paragraph num="(iv)"> <text>Pest control and prevention; and</text> </paragraph> <paragraph num="(v)"> <text>Receiving, storing, preparing, and serving food.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>The owner of a cottage food business may not sell or offer for sale a cottage food product to a retail food store until notified by the Department, in writing, that the requirements stated in §C(6) of this regulation are satisfactorily met.</text> </paragraph> <paragraph num="(8)"> <text>The phone number required in §§C(1)(c)(i) and (viii) of this regulation shall enable contact with the cottage food business by the Department within 24 hours.</text> </paragraph> <paragraph num="(9)"> <text>The email address required in §C(1)(c)(i) of this regulation shall enable contact with the cottage food business by the Department within 48 hours.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department finds a person to be in violation of any provision of this regulation, the Department:</text> <paragraph num="(1)"> <text>Shall take action against a misbranded or adulterated food offered or sold under this regulation in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>May determine that food produced in a private home kitchen by the person may not be offered for sale as a cottage food.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Licenses."> <paragraph num="A."> <text>The approving authority shall require a farmer to obtain a producer mobile farmer's market unit license as specified in COMAR 10.01.17 and 10.15.04 for the sale of a farm product at a farmer's market or at a public event that is not:</text> <paragraph num="(1)"> <text>A raw agricultural product as defined in Regulation .02B(61) of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>A pre-packaged non-potentially hazardous food.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A local health department may:</text> <paragraph num="(1)"> <text>Not require a farmer to obtain a producer mobile farmer's market unit license for that local jurisdiction; and</text> </paragraph> <paragraph num="(2)"> <text>Require a farmer to obtain a seasonal farmer's market producer sampling license if the farmer prepares and offers samples of a farm product for human consumption at a farmer's market or at a public event in that local jurisdiction.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The approving authority shall issue and renew licenses in accordance with Health-General Article, §§21-309 and 21-310, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="D."> <text>The approving authority may deny an application for a food service facility license in accordance with Health-General Article, §21-311, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="E."> <text>A person:</text> <paragraph num="(1)"> <text>Shall obtain a food service facility license before the person operates a food service facility; and</text> </paragraph> <paragraph num="(2)"> <text>May not operate a food service facility if the person does not have a current and valid license issued by the approving authority, except:</text> <paragraph num="(a)"> <text>As provided in:</text> <paragraph num="(i)"> <text>Health-General Article, §21-305, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulation .26A(2) of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A caterer:</text> <paragraph num="(i)"> <text>As provided in §G of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>When from outside the State, that conforms to the provisions of this chapter or to substantially equivalent provisions as indicated by a report from the caterer's licensing agency to the approving authority indicating that the facility is licensed and inspected in the jurisdiction where the food service facility is located.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Application for a food service facility license is submitted in accordance with Health-General Article, §§21-306 and 21-307, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A valid license is displayed in a conspicuous place in the food service facility; and</text> </paragraph> <paragraph num="(3)"> <text>When catering services are offered, the food service facility license number and the identity of the issuer of the number are located:</text> <paragraph num="(a)"> <text>On advertising and business cards;</text> </paragraph> <paragraph num="(b)"> <text>In published print media;</text> </paragraph> <paragraph num="(c)"> <text>On flyers;</text> </paragraph> <paragraph num="(d)"> <text>In brochures;</text> </paragraph> <paragraph num="(e)"> <text>On vehicles used in connection with catering services;</text> </paragraph> <paragraph num="(f)"> <text>On contracts for catering services;</text> </paragraph> <paragraph num="(g)"> <text>In telephone directories; and</text> </paragraph> <paragraph num="(h)"> <text>In or on any other advertising and solicitations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The approving authority may not require a caterer licensed in Maryland to obtain a separate license for each catered event, including events across jurisdictional lines within the State, when the:</text> <paragraph num="(1)"> <text>Major food preparation for the event is completed at the caterer's food service facility, including:</text> <paragraph num="(a)"> <text>Thawing potentially hazardous food;</text> </paragraph> <paragraph num="(b)"> <text>Cooking potentially hazardous food, except at outdoor barbecues when the food will be immediately consumed or discarded;</text> </paragraph> <paragraph num="(c)"> <text>Cooling potentially hazardous food; or</text> </paragraph> <paragraph num="(d)"> <text>Preparing salads that contain potentially hazardous foods; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Event is at a location other than the caterer’s food service facility if the caterer and location comply with Regulations .01—.06, .08—.14, .15A(3)—(8), and .18I and L of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Except as provided in §I of this regulation, a license may not be transferred from one person to another person or from one food service facility to another.</text> </paragraph> <paragraph num="I."> <text>Upon the death of a licensee, the approving authority may transfer a food service facility license if:</text> <paragraph num="(1)"> <text>An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Written evidence establishes that the applicant's relationship with the deceased was as a:</text> <paragraph num="(a)"> <text>Spouse of the deceased licensee;</text> </paragraph> <paragraph num="(b)"> <text>Blood relative to the first degree of consanguinity; or</text> </paragraph> <paragraph num="(c)"> <text>Current officer or surviving partner in the business operating the food service facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>A local health department:</text> <paragraph num="(1)"> <text>Shall issue a mobile reciprocity license:</text> <paragraph num="(a)"> <text>In accordance with Health-General Article, §21-304, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>To a mobile food service facility that:</text> <paragraph num="(i)"> <text>Holds a valid license from the county of origin;</text> </paragraph> <paragraph num="(ii)"> <text>Is operating in the jurisdiction; and</text> </paragraph> <paragraph num="(iii)"> <text>Is operating within 90 miles of its base of operations, which shall be located in Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall provide copies of inspection or other supporting documentation for a mobile food service facility with a base of operations within the jurisdiction of the local health department to the jurisdiction in which the mobile food service facility is seeking a mobile reciprocity license;</text> </paragraph> <paragraph num="(3)"> <text>May inspect the mobile food service facility during operation in the jurisdiction after a mobile reciprocity license has been issued;</text> </paragraph> <paragraph num="(4)"> <text>May suspend a mobile reciprocity license for not maintaining a valid license from the county of origin until such time that the county of origin license is renewed;</text> </paragraph> <paragraph num="(5)"> <text>May issue a violation of this regulation as set forth in Regulation .35 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Shall notify all known Maryland jurisdictions which license the mobile food service facility if:</text> <paragraph num="(a)"> <text>Any fines are issued to a mobile reciprocity licensee; or</text> </paragraph> <paragraph num="(b)"> <text>Enforcement action is taken against a mobile reciprocity licensee under §J(3) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>A mobile reciprocity license:</text> <paragraph num="(1)"> <text>May not exceed $300; and</text> </paragraph> <paragraph num="(2)"> <text>Is valid for a period of 1 year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Food Service Facility Inspections — General."> <paragraph num="A."> <text>The person-in-charge shall permit a representative of the approving authority to:</text> <paragraph num="(1)"> <text>Enter a food service facility at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Examine the records of the facility that pertain to information regarding food and supplies purchased, received, or used.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge shall inform the approving authority of, and keep confidential, a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>The person-in-charge shall furnish information to the approving authority regarding a food ingredient or recipe that the person-in-charge considers a trade secret if:</text> <paragraph num="(1)"> <text>An immediate and substantial danger to public health exists involving the food ingredient or recipe; or</text> </paragraph> <paragraph num="(2)"> <text>The approving authority determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The approving authority shall maintain the confidentiality of trade secret information in accordance with State Government Article, §10-617, and Health-General Article, §21-259, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>When an inspection of a food service facility is made, the approving authority shall:</text> <paragraph num="(1)"> <text>Document:</text> <paragraph num="(a)"> <text>The inspection results on an inspection report form provided by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>On the report:</text> <paragraph num="(i)"> <text>Conditions found that violate the provisions of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Critical item violations, noted separately from all other violations;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Furnish one copy of the inspection report to the person-in-charge of the facility; and</text> </paragraph> <paragraph num="(3)"> <text>Make the completed inspection report form available for public disclosure in accordance with State Government Article, §10-611—10-628, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Food Service Facility Inspections — Types and Frequencies."> <text>The approving authority shall ensure that:</text> <paragraph num="A."> <text>The following types of inspections are conducted:</text> <paragraph num="(1)"> <text>A comprehensive inspection that contains:</text> <paragraph num="(a)"> <text>A monitoring inspection as set forth in §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>A HACCP compliance inspection as set forth in §A(3) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>An inspection of the physical facility to ensure compliance with the applicable sections of this chapter, including those governing:</text> <paragraph num="(i)"> <text>Floors;</text> </paragraph> <paragraph num="(ii)"> <text>Walls;</text> </paragraph> <paragraph num="(iii)"> <text>Ceilings;</text> </paragraph> <paragraph num="(iv)"> <text>Lighting;</text> </paragraph> <paragraph num="(v)"> <text>Ventilation;</text> </paragraph> <paragraph num="(vi)"> <text>Hoods;</text> </paragraph> <paragraph num="(vii)"> <text>Food equipment;</text> </paragraph> <paragraph num="(viii)"> <text>Toxic substances and cleaning supplies storage and use;</text> </paragraph> <paragraph num="(ix)"> <text>Cleaning, rinsing, and sanitizing;</text> </paragraph> <paragraph num="(x)"> <text>Mechanical warewashers;</text> </paragraph> <paragraph num="(xi)"> <text>Insects, rodents, birds, or other animals;</text> </paragraph> <paragraph num="(xii)"> <text>Trash disposal;</text> </paragraph> <paragraph num="(xiii)"> <text>Hand sinks;</text> </paragraph> <paragraph num="(xiv)"> <text>Bathroom fixtures; and</text> </paragraph> <paragraph num="(xv)"> <text>Backflow and backsiphonage prevention;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A monitoring inspection that contains:</text> <paragraph num="(a)"> <text>An inspection for compliance with critical items as:</text> <paragraph num="(i)"> <text>Defined in Regulation .02B(19) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Outlined in §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A menu review to determine whether the existing priority assessment is correct; and</text> </paragraph> <paragraph num="(c)"> <text>An evaluation of the physical facility to ensure that food is protected; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A HACCP compliance inspection that contains:</text> <paragraph num="(a)"> <text>An inspection for compliance with Regulation .34 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>A comparison of the HACCP plan on site to the current menu;</text> </paragraph> <paragraph num="(c)"> <text>An evaluation of the food preparation in progress to ensure that each CCP:</text> <paragraph num="(i)"> <text>Is properly identified;</text> </paragraph> <paragraph num="(ii)"> <text>Is monitored according to the procedures contained in the HACCP plan; and</text> </paragraph> <paragraph num="(iii)"> <text>Has a corrective action that is implemented according to procedures contained in the HACCP plan;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Verification that the procedures used to monitor each CCP are accurate; and</text> </paragraph> <paragraph num="(e)"> <text>Action to:</text> <paragraph num="(i)"> <text>Enforce compliance with the HACCP plan; or</text> </paragraph> <paragraph num="(ii)"> <text>Have the existing HACCP plan revised to comply with Regulation .33E and F of this chapter;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge is in compliance with critical items when the person-in-charge:</text> <paragraph num="(1)"> <text>Receives food from approved sources;</text> </paragraph> <paragraph num="(2)"> <text>Protects food from adulteration;</text> </paragraph> <paragraph num="(3)"> <text>Ensures that an individual who works with food:</text> <paragraph num="(a)"> <text>Washes hands as necessary to protect food and food contact surfaces from contamination; and</text> </paragraph> <paragraph num="(b)"> <text>Is excluded if ill as set forth in Regulation .14A and B of this chapter;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Cools potentially hazardous food:</text> <paragraph num="(a)"> <text>As set forth in Regulation .11A—C of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>In equipment that complies with Regulation .15 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintains potentially hazardous food:</text> <paragraph num="(a)"> <text>Hot:</text> <paragraph num="(i)"> <text>At hot holding temperatures as set forth in Regulation .06B(7) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>In equipment that complies with Regulation .15 of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Cold:</text> <paragraph num="(i)"> <text>At refrigeration temperatures as set forth in Regulation .06B(7) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>In equipment that complies with Regulation .15 of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Cooks and reheats potentially hazardous food:</text> <paragraph num="(a)"> <text>As set forth in Regulations .10 and .11D of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>In equipment that complies with Regulation .15 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Provides an adequate supply of potable water for:</text> <paragraph num="(a)"> <text>Food preparation;</text> </paragraph> <paragraph num="(b)"> <text>Hand washing;</text> </paragraph> <paragraph num="(c)"> <text>Utensil washing;</text> </paragraph> <paragraph num="(d)"> <text>Toilet facilities; and</text> </paragraph> <paragraph num="(e)"> <text>Facility sanitation; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Properly discharges sewage as set forth in Regulation .18F and G of this chapter;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A food service facility is inspected:</text> <paragraph num="(1)"> <text>As needed for the enforcement of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>When a high priority food service facility:</text> <paragraph num="(a)"> <text>At a minimum frequency of three times per year, one at every 4-month interval;</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §D of this regulation, using:</text> <paragraph num="(i)"> <text>A comprehensive inspection; and</text> </paragraph> <paragraph num="(ii)"> <text>Two monitoring inspections; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That operates fewer than 12 months in a year, using one comprehensive inspection:</text> <paragraph num="(i)"> <text>Per operating season if the operating season is less than 4 months; or</text> </paragraph> <paragraph num="(ii)"> <text>During each 4 month interval if the operating season is 4 months or greater;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>When a moderate priority food service facility:</text> <paragraph num="(a)"> <text>At a minimum of two times per year, one every 6 months;</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §D of this regulation, using:</text> <paragraph num="(i)"> <text>A comprehensive inspection; and</text> </paragraph> <paragraph num="(ii)"> <text>A monitoring inspection; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That operates fewer than 12 months a year, using a comprehensive inspection during each period of 6 months or less;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When a low priority food service facility, using a comprehensive inspection at a minimum of once every 2 years except that a HACCP compliance inspection is not required;</text> </paragraph> <paragraph num="(5)"> <text>When a temporary food service facility, using a monitoring inspection as set forth in Regulation .30A(2) of this chapter during each licensure period; and</text> </paragraph> <paragraph num="(6)"> <text>When a seasonal farmer’s market producer sampling food service facility, using a monitoring inspection:</text> <paragraph num="(a)"> <text>A minimum of two times per year, once every 6-month interval;</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §D of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>That operates fewer than 12 months in a year:</text> <paragraph num="(i)"> <text>Per operating season if the operating season is less than 6 months; or</text> </paragraph> <paragraph num="(ii)"> <text>During each 6-month interval if the operating season is 6 months or greater; and</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A food service facility is inspected as soon as possible when the food service facility has been associated with foodborne illness, using a:</text> <paragraph num="(1)"> <text>HACCP compliance inspection that focuses on the food implicated with illness; and</text> </paragraph> <paragraph num="(2)"> <text>Upon completion of the HACCP compliance inspection, either a:</text> <paragraph num="(a)"> <text>Comprehensive inspection; or</text> </paragraph> <paragraph num="(b)"> <text>Monitoring inspection.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Time Period for Correction of Violations."> <paragraph num="A."> <text>The person-in-charge shall correct:</text> <paragraph num="(1)"> <text>Critical item violations immediately;</text> </paragraph> <paragraph num="(2)"> <text>Other violations except as provided in §A(3) of this regulation within:</text> <paragraph num="(a)"> <text>30 days of the inspection; or</text> </paragraph> <paragraph num="(b)"> <text>Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Other violations at a temporary food service facility within:</text> <paragraph num="(a)"> <text>24 hours of the inspection; or</text> </paragraph> <paragraph num="(b)"> <text>Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The approving authority may modify the specified time period for correcting a violation if the person-in-charge:</text> <paragraph num="(1)"> <text>Submits a written schedule of compliance within a time frame for correcting a violation that is acceptable to the approving authority; and</text> </paragraph> <paragraph num="(2)"> <text>There is no immediate or substantial danger to public health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Required Postings."> <text>The person-in-charge shall ensure that a food service facility:</text> <paragraph num="A."> <text>That prepares food and provides seating for patrons posts a diagram on the use of manual maneuvers to prevent asphyxiation due to choking, in accordance with Health-General Article, §21-326, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>Displays prominently in the staff area of the food establishment a poster related to food allergy awareness that includes information regarding the risk of an allergic reaction, in accordance with Health-General Article, §21-330.2(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Plan Review."> <paragraph num="A."> <text>The person-in-charge shall ensure that plans and specifications are submitted to and approved by the approving authority before a food establishment is:</text> <paragraph num="(1)"> <text>Constructed;</text> </paragraph> <paragraph num="(2)"> <text>Remodeled; or</text> </paragraph> <paragraph num="(3)"> <text>Materially altered.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that the information submitted to the approving authority includes:</text> <paragraph num="(1)"> <text>A scale drawing of the proposed facility that identifies the layout and arrangement of work areas and the location of all equipment;</text> </paragraph> <paragraph num="(2)"> <text>A description of:</text> <paragraph num="(a)"> <text>Materials to be used for interior finishes;</text> </paragraph> <paragraph num="(b)"> <text>The layout and types of lighting to be used;</text> </paragraph> <paragraph num="(c)"> <text>The proposed ventilation system; and</text> </paragraph> <paragraph num="(d)"> <text>Methods and facilities for trash storage and disposal;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A plumbing diagram, including specifications of the method of sewage disposal and the source of potable water;</text> </paragraph> <paragraph num="(4)"> <text>A complete list of specifications for the proposed food equipment;</text> </paragraph> <paragraph num="(5)"> <text>A menu or other written description of the foods to be prepared or served;</text> </paragraph> <paragraph num="(6)"> <text>General food handling information and procedures for:</text> <paragraph num="(a)"> <text>Receiving;</text> </paragraph> <paragraph num="(b)"> <text>Storage;</text> </paragraph> <paragraph num="(c)"> <text>Thawing; and</text> </paragraph> <paragraph num="(d)"> <text>Preparation;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A list of foods that will be:</text> <paragraph num="(a)"> <text>Prepared in advance of service; or</text> </paragraph> <paragraph num="(b)"> <text>Distributed off premises;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A description of the food systems that will be used, such as:</text> <paragraph num="(a)"> <text>Cook-hot hold-serve;</text> </paragraph> <paragraph num="(b)"> <text>Cook-cool-reheat-hot hold-serve; and</text> </paragraph> <paragraph num="(c)"> <text>Cook-cool-cold hold-serve; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Any other information that is required by the approving authority to ascertain compliance of the plans and specifications with all applicable State and local laws, regulations, and ordinances.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The approving authority shall:</text> <paragraph num="(1)"> <text>Conduct a priority assessment of the facility based upon the information obtained in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Classify each food service facility as a:</text> <paragraph num="(a)"> <text>High priority facility;</text> </paragraph> <paragraph num="(b)"> <text>Moderate priority facility; or</text> </paragraph> <paragraph num="(c)"> <text>Low priority facility;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Designate as a high priority facility, a facility that:</text> <paragraph num="(a)"> <text>Is a health care facility; or</text> </paragraph> <paragraph num="(b)"> <text>Serves potentially hazardous food that is prepared:</text> <paragraph num="(i)"> <text>A day or more in advance of service; or</text> </paragraph> <paragraph num="(ii)"> <text>Using food preparation methods that require the food to pass through the temperature range of 41°F to 135°F two or more times before service, such as cooking, cooling, and then reheating;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Designate as a moderate priority facility, a facility that serves potentially hazardous food:</text> <paragraph num="(a)"> <text>That is prepared using methods that require the food to pass through the temperature range of 41°F to 135°F not more than one time before service, such as cooking, hot holding, and then serving; or</text> </paragraph> <paragraph num="(b)"> <text>That is cut, assembled, or packaged on the premises, such as meats; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Designate as a low priority facility, a facility that serves:</text> <paragraph num="(a)"> <text>Commercially packaged potentially hazardous foods directly to the consumer;</text> </paragraph> <paragraph num="(b)"> <text>Non-potentially hazardous food that is cut, assembled, or packaged on the premises, such as candy, popcorn, and baked goods; or</text> </paragraph> <paragraph num="(c)"> <text>Hand dipped ice cream.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Except for a temporary food service facility, the person-in-charge shall ensure that a HACCP plan is submitted to the approving authority for each high or moderate priority facility as specified in §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>The person-in-charge shall ensure that the HACCP plan includes the:</text> <paragraph num="(1)"> <text>Identification of each CCP;</text> </paragraph> <paragraph num="(2)"> <text>Critical limits for each CCP;</text> </paragraph> <paragraph num="(3)"> <text>Monitoring procedures at each CCP;</text> </paragraph> <paragraph num="(4)"> <text>Corrective action that will be taken if there is a loss of control at a CCP due to:</text> <paragraph num="(a)"> <text>Employee error;</text> </paragraph> <paragraph num="(b)"> <text>Equipment malfunction;</text> </paragraph> <paragraph num="(c)"> <text>Power failure; or</text> </paragraph> <paragraph num="(d)"> <text>Any other factor that causes loss of control at a CCP;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Verification procedures that will ensure proper monitoring of each CCP, such as:</text> <paragraph num="(a)"> <text>Calibration of cooking and holding equipment and thermometers; and</text> </paragraph> <paragraph num="(b)"> <text>Review of records such as temperature logs;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Written procedures for employee training in HACCP plan procedures; and</text> </paragraph> <paragraph num="(7)"> <text>A list of the food service equipment that will be used at each CCP.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The person-in-charge shall construct the HACCP plan by:</text> <paragraph num="(1)"> <text>Listing, for each CCP, the:</text> <paragraph num="(a)"> <text>Menu items controlled by the CCP;</text> </paragraph> <paragraph num="(b)"> <text>Equipment used; and</text> </paragraph> <paragraph num="(c)"> <text>Monitoring, corrective action, and verification procedures;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Incorporation of the requirements of §E of this regulation into a recipe or preparation instructions; or</text> </paragraph> <paragraph num="(3)"> <text>Another way that meets the requirements of §E of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="HACCP Plan Compliance."> <text>The person-in-charge of a high or moderate priority food service facility shall ensure that:</text> <paragraph num="A."> <text>A HACCP plan is:</text> <paragraph num="(1)"> <text>In compliance with Regulation .33E and F of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Within the food preparation area during operation;</text> </paragraph> <paragraph num="(3)"> <text>Readily accessible to employees at all times; and</text> </paragraph> <paragraph num="(4)"> <text>Updated as follows:</text> <paragraph num="(a)"> <text>When a change in food processes or procedures change one or more CCP; and</text> </paragraph> <paragraph num="(b)"> <text>At least once every 5 years;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An employee involved in food preparation is trained in the HACCP procedures; and</text> </paragraph> <paragraph num="C."> <text>Changes to the HACCP plan are submitted to the approving authority before implementation of the HACCP plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Enforcement Procedures."> <paragraph num="A."> <text>The approving authority shall ensure that when a food service facility is found in violation of any provision of this chapter, the licensee is notified:</text> <paragraph num="(1)"> <text>Of the specific findings;</text> </paragraph> <paragraph num="(2)"> <text>Of a specific date by which the licensee shall correct the violations or deficiencies; and</text> </paragraph> <paragraph num="(3)"> <text>That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-318 or 21-261, Annotated Code of Maryland, directing the person to abate the violation within a specified time period.</text> </paragraph> <paragraph num="C."> <text>When an inspection indicates that an immediate and substantial danger to public health exists and requires emergency action at a facility operated by an excluded organization, the approving authority may seek injunctive relief as provided in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>In order to preserve a right to a hearing under any provision of this regulation, a person shall:</text> <paragraph num="(1)"> <text>Make a request for a hearing in writing; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the request to the approving authority that issued the order or inspection report:</text> <paragraph num="(a)"> <text>Within 10 days of receipt of the order;</text> </paragraph> <paragraph num="(b)"> <text>Sooner if specified in the order; or</text> </paragraph> <paragraph num="(c)"> <text>Within 24 hours if:</text> <paragraph num="(i)"> <text>The violation requires immediate correction or correction within 24 hours; or</text> </paragraph> <paragraph num="(ii)"> <text>The facility is a temporary food service facility.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The approving authority shall suspend or revoke the license of a food service facility if the licensee fails or neglects to:</text> <paragraph num="(1)"> <text>Correct a violation within the specified time period;</text> </paragraph> <paragraph num="(2)"> <text>Comply with an approved written schedule of compliance;</text> </paragraph> <paragraph num="(3)"> <text>Correct a critical item immediately; or</text> </paragraph> <paragraph num="(4)"> <text>Correct a violation in a temporary food service facility within 24 hours.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The approving authority shall ensure that an action to suspend or revoke a license:</text> <paragraph num="(1)"> <text>Complies with the provisions of:</text> <paragraph num="(a)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Health-General Article, §21-315, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="H."> <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:</text> <paragraph num="(1)"> <text>Approving authority shall:</text> <paragraph num="(a)"> <text>Summarily suspend the license at a food service facility;</text> </paragraph> <paragraph num="(b)"> <text>Order the food service facility to cease operation immediately; and</text> </paragraph> <paragraph num="(c)"> <text>Promptly provide the licensee with:</text> <paragraph num="(i)"> <text>A written notice of suspension of the license;</text> </paragraph> <paragraph num="(ii)"> <text>The reasons for the suspension; and</text> </paragraph> <paragraph num="(iii)"> <text>An opportunity to be heard; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Person-in-charge shall immediately cease the operation of the food service facility.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The person-in-charge shall ensure that a food service facility that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exists.</text> </paragraph> <paragraph num="J."> <text>The approving authority shall ensure that appropriate steps are taken to ensure that the licensee ceases operation of the food service facility upon suspension or revocation of the license, including:</text> <paragraph num="(1)"> <text>Taking and keeping physical possession of the license until the license is reinstated;</text> </paragraph> <paragraph num="(2)"> <text>Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority; or</text> </paragraph> <paragraph num="(3)"> <text>Taking another measure within the law that will ensure that the facility does not operate.</text> </paragraph> </paragraph> <paragraph num="K."> <text>A person whose food service facility license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Foodborne Disease Investigation and Control."> <text>The approving authority shall ensure that:</text> <paragraph num="A."> <text>When there is reasonable cause to suspect foodborne disease transmission from a food service facility employee:</text> <paragraph num="(1)"> <text>A morbidity history of the suspected employee is taken;</text> </paragraph> <paragraph num="(2)"> <text>An investigation is conducted; and</text> </paragraph> <paragraph num="(3)"> <text>The appropriate follow-up action is taken that may include:</text> <paragraph num="(a)"> <text>Immediate exclusion of the employee from all food handling positions within the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Immediate closing of the food service facility until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An investigation, a report, and the control of a foodborne disease outbreak is conducted in accordance with the provisions of COMAR 10.06.01.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Sampling, Detention, and Condemnation of Food."> <text>The approving authority shall:</text> <paragraph num="A."> <text>Sample and examine food as often as necessary for enforcement of this chapter;</text> </paragraph> <paragraph num="B."> <text>Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>Take action on a food in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by:</text> <paragraph num="(1)"> <text>Issuing a detention order;</text> </paragraph> <paragraph num="(2)"> <text>Destroying the food; or</text> </paragraph> <paragraph num="(3)"> <text>Making the food unusable for consumption.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Penalties."> <text>A person who violates any of the provisions of this chapter or refuses, neglects, or fails to comply with the provisions and requirements of this chapter is subject to:</text> <paragraph num="A."> <text>Penalties, fines, and imprisonment as set forth in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>Penalties and fines as provided by local law, ordinance, or regulation in accordance with Health-General Article, §21-309.2(e)(3), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Federal Compliance."> <text>In addition to the other requirements set forth in this chapter, the person in charge shall ensure that the food service facility meets all of the requirements applicable to food sources, storage, preparation, and service that are set forth at:</text> <paragraph num="A."> <text>21 CFR, as amended;</text> </paragraph> <paragraph num="B."> <text>9 CFR, as amended; and</text> </paragraph> <paragraph num="C."> <text>21 U.S.C. §343, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Micro Markets."> <paragraph num="A."> <text>The owner or operator of a micro market may not be required to have a person-in-charge present during the hours of operation of the micro market if the micro market meets the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>Food sold at a micro market shall:</text> <paragraph num="(1)"> <text>Be commercially prepackaged food or ready-to-eat food;</text> </paragraph> <paragraph num="(2)"> <text>Be prepackaged in tamper-evident packaging; and</text> </paragraph> <paragraph num="(3)"> <text>Contain all the following information on the packaging label:</text> <paragraph num="(a)"> <text>Nutrition information required by the federal Food, Drug, and Cosmetic Act;</text> </paragraph> <paragraph num="(b)"> <text>A freshness or expiration date; and</text> </paragraph> <paragraph num="(c)"> <text>Any other information required by Maryland law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Refrigerated or frozen food sold at a micro market shall be stored and displayed in a refrigerator, refrigerated cooler, or freezer that:</text> <paragraph num="(1)"> <text>Maintains an internal temperature of 41°F or lower;</text> </paragraph> <paragraph num="(2)"> <text>Has self-closing doors;</text> </paragraph> <paragraph num="(3)"> <text>Has doors that allow the food on display to be viewed without opening the door to the refrigerator, refrigerated cooler, or freezer; and</text> </paragraph> <paragraph num="(4)"> <text>Has an automated self-locking feature that prevents a consumer from accessing the food on the occurrence of any condition that results in the failure of the refrigerator, refrigerated cooler, or freezer to maintain the internal temperature required under Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Signage and Notice. The owner or operator of a micro market shall post a sign that is clearly visible to the consumer near the micro market entryway or while using the electronic payment device that includes the following information:</text> <paragraph num="(1)"> <text>The name of the owner or operator of the micro market to whom complaints and comments regarding the micro market may be addressed;</text> </paragraph> <paragraph num="(2)"> <text>The business mailing address of the owner or operator;</text> </paragraph> <paragraph num="(3)"> <text>The business telephone number of the owner or operator; and</text> </paragraph> <paragraph num="(4)"> <text>The email address and website address of the owner or operator, if applicable.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Security. The owner or operator of a micro market:</text> <paragraph num="(1)"> <text>May secure the products and premises of a micro market by the use of video surveillance that:</text> <paragraph num="(a)"> <text>Operates 24 hours per day, 7 days per week;</text> </paragraph> <paragraph num="(b)"> <text>Records consumers viewing, selecting, handling, and purchasing products from the micro market; and</text> </paragraph> <paragraph num="(c)"> <text>Provides sufficient resolution to identify consumers described in §E(1)(b) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall ensure that video surveillance recordings made under §E(1) of this regulation are:</text> <paragraph num="(a)"> <text>Maintained by the owner for 14 days after the date of the video recording; and</text> </paragraph> <paragraph num="(b)"> <text>Made available for inspection by the appropriate health or law enforcement agency on the request of the agency within 24 hours from the time the request is received by the owner or operator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Record Keeping. The owner or operator of a micro market shall ensure that:</text> <paragraph num="(1)"> <text>In the event of a failure of an automated self-locking unit, records are kept for:</text> <paragraph num="(a)"> <text>The repair or replacement of the failed unit in the form of receipts or a completed service order; and</text> </paragraph> <paragraph num="(b)"> <text>All products in the unit at the time of the failure and include:</text> <paragraph num="(i)"> <text>Product description; and</text> </paragraph> <paragraph num="(ii)"> <text>Quantity of products discarded or destroyed;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Service receipts for the repair or replacement of the failed unit and product destruction shall be kept for a minimum of 90 days; and</text> </paragraph> <paragraph num="(3)"> <text>All records are available for review upon request.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-202, 21-234, 21-301, 21-304, 21-308, 21-309.1, 21-309.2, 21-324.1, and 21-330.1; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:28 Md. R. 1669)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01; .02K, N, X; .03A, B; .05B; .06D, G; .07A—C; .08B amended and .02Q-1 adopted effective December 19, 1983 (10:25 Md. R. 2268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02X adopted effective September 21, 1979 (6:19 Md. R. 1518)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B, .05B, .07E, and .09B, C amended effective September 21, 1979 (6:19 Md. R. 1518)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C adopted effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403); July 27, 1998 (25:15 Md. R. 1191)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B and F amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 6, 1997 (24:20 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B, and D amended effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and new Regulation .11 adopted effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B and C amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 recodified to Regulation .25 effective March 4, 1991</annotation> <annotation type="History" subtype="Administrative History">Regulations .12—.24 adopted effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Form DHMH 205 repealed effective March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.25 repealed and new Regulations .01—.39 adopted effective December 17, 2007 (34:25 Md. R. 2211)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); February 15, 2016 (43:3 Md. R. 272); December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875); December 11, 2023 (50:24 M. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14F amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14I amended effective February 3, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17G amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18H, I amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective March 4, 2013 (40:4 Md. R. 346)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22B, I amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective February 3, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23L amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24B amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25A, B amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25C amended effective December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26G amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective March 19, 2010 (37:4 Md. R. 341); February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); October 5, 2020 (47:20 Md. R. 875); December 11. 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C amended effective February 15, 2016 (43:3 Md. R. 272); December 27, 2021 (48:26 Md. R. 1111)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C amended as an emergency provision effective November 27, 2024 (51:26 Md. R. 1185); amended permanently effective April 28, 2025 (52:8 Md. R. 358)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective February 3, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28C, E amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28G, J amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28J, K adopted effective December 31, 2018 (45:26 Md. R. 1245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30B amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30B, C amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .32, Choking Posters, renamed, Required Postings and amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33A, C amended effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33C, D amended effective February 3, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .38 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .40 adopted effective October 5, 2020 (47:20 Md. R. 875)</annotation> </annotations> </chapter> <chapter num="04" heading="Food and Drink Processing and Transportation"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Provides the minimum food safety and sanitation requirements for food processing plants, including warehouses and transfer stations, and the transportation of food;</text> </paragraph> <paragraph num="B."> <text>Is not intended to govern a meat processing plant that solely processes meat products under the regulation and inspection of the United States Department of Agriculture in accordance with the Code of Federal Regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Adulterated Food.</text> <paragraph num="(a)"> <text>“Adulterated food” has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Adulterated food” includes food that is:</text> <paragraph num="(i)"> <text>Is diseased;</text> </paragraph> <paragraph num="(ii)"> <text>Is contaminated;</text> </paragraph> <paragraph num="(iii)"> <text>Is filthy;</text> </paragraph> <paragraph num="(iv)"> <text>Is putrid;</text> </paragraph> <paragraph num="(v)"> <text>Has decomposed;</text> </paragraph> <paragraph num="(vi)"> <text>Contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health;</text> </paragraph> <paragraph num="(vii)"> <text>Contains any food additive or color additive, the particular use of which has not been found safe as provided under Health-General Article, §21-239, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(viii)"> <text>Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have contaminated it with filth;</text> </paragraph> <paragraph num="(ix)"> <text>Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have caused it to be diseased, unwholesome, or injurious to health;</text> </paragraph> <paragraph num="(x)"> <text>Was packaged in a container composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the food to be injurious to health; or</text> </paragraph> <paragraph num="(xi)"> <text>Is misbranded so that the food is unsafe for human consumption.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Allergen cross-contact” means the unintentional incorporation of a food allergen into a food that has not been identified as containing it.</text> </paragraph> <paragraph num="(3)"> <text>“Approving authority” means the agency designated in the laws of another state or country to license or permit a food processing plant.</text> </paragraph> <paragraph num="(4)"> <text>“Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source:</text> <paragraph num="(a)"> <text>Are not adulterated foods or misbranded as defined in §B(1) and (21) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Where required, are regulated by the approving authority.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Charity deer processing” means the processing of legally harvested whitetail deer into cuts of raw meat as only a service for a charitable organization that donates the meat to the needy for consumption.</text> </paragraph> <paragraph num="(6)"> <text>“Contamination” means the process or state that potentially renders a food unsafe for human consumption due to the adulteration of the food with:</text> <paragraph num="(a)"> <text>Pathogens;</text> </paragraph> <paragraph num="(b)"> <text>Chemicals;</text> </paragraph> <paragraph num="(c)"> <text>Allergens;</text> </paragraph> <paragraph num="(d)"> <text>Foreign objects; or</text> </paragraph> <paragraph num="(e)"> <text>Filth.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Corrective action” means the documented steps taken when a deviation occurs at a control point to:</text> <paragraph num="(a)"> <text>Address the cause of the deviation;</text> </paragraph> <paragraph num="(b)"> <text>Restore control; and</text> </paragraph> <paragraph num="(c)"> <text>Prevent the affected food from entering commerce.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Critical control point” means a step or procedure in a food process at which control can be applied, and is essential to:</text> <paragraph num="(a)"> <text>Prevent a food safety hazard;</text> </paragraph> <paragraph num="(b)"> <text>Eliminate a food safety hazard; or</text> </paragraph> <paragraph num="(c)"> <text>Reduce a hazard to an acceptable level.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Critical Item.</text> <paragraph num="(a)"> <text>“Critical item” means a food safety requirement that if violated requires:</text> <paragraph num="(i)"> <text>Immediate correction;</text> </paragraph> <paragraph num="(ii)"> <text>The cessation of some or all processing operations; or</text> </paragraph> <paragraph num="(iii)"> <text>Plant closure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Critical item” includes the following requirements:</text> <paragraph num="(i)"> <text>Food is obtained from an approved source;</text> </paragraph> <paragraph num="(ii)"> <text>Food is protected from contamination and allergen cross-contact;</text> </paragraph> <paragraph num="(iii)"> <text>Food processes provide safe food with proper control at critical control points;</text> </paragraph> <paragraph num="(iv)"> <text>Food is protected by ensuring that all personnel wash hands thoroughly as often as necessary to prevent food contamination by hand contact;</text> </paragraph> <paragraph num="(v)"> <text>Personnel are restricted from food handling positions or the plant as indicated if they have an illness or infection that is transmissible through food as defined in COMAR 10.06.01.06E;</text> </paragraph> <paragraph num="(vi)"> <text>Food is packaged and labeled for safety with allergens properly identified on the label;</text> </paragraph> <paragraph num="(vii)"> <text>A sufficient volume of potable hot and cold water supply under pressure is available; and</text> </paragraph> <paragraph num="(viii)"> <text>Sewage is discharged in compliance with applicable laws and regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(11)"> <text>Farm.</text> <paragraph num="(a)"> <text>“Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes.</text> </paragraph> <paragraph num="(b)"> <text>“Farm” includes a place where, for commercial purposes:</text> <paragraph num="(i)"> <text>Crops are grown and harvested;</text> </paragraph> <paragraph num="(ii)"> <text>Fruit, nuts, or other agricultural commodities are harvested from trees; or</text> </paragraph> <paragraph num="(iii)"> <text>Animals are raised, fed, and managed for meat or other agricultural commodities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Food” means:</text> <paragraph num="(a)"> <text>Articles used for food or drink for humans or other animals;</text> </paragraph> <paragraph num="(b)"> <text>Chewing gum; and</text> </paragraph> <paragraph num="(c)"> <text>Individual components of such articles.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Food allergen” means an ingredient that contains protein derived from one of the following foods or food groups:</text> <paragraph num="(a)"> <text>Milk;</text> </paragraph> <paragraph num="(b)"> <text>Egg;</text> </paragraph> <paragraph num="(c)"> <text>Fish;</text> </paragraph> <paragraph num="(d)"> <text>Crustacean shellfish;</text> </paragraph> <paragraph num="(e)"> <text>Tree nuts;</text> </paragraph> <paragraph num="(f)"> <text>Wheat;</text> </paragraph> <paragraph num="(g)"> <text>Peanuts;</text> </paragraph> <paragraph num="(h)"> <text>Soybeans; or</text> </paragraph> <paragraph num="(i)"> <text>Sesame.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Food Processing Plant.</text> <paragraph num="(a)"> <text>“Food processing plant” means a place used for or in connection with commercial food:</text> <paragraph num="(i)"> <text>Manufacturing;</text> </paragraph> <paragraph num="(ii)"> <text>Processing;</text> </paragraph> <paragraph num="(iii)"> <text>Packing;</text> </paragraph> <paragraph num="(iv)"> <text>Repacking;</text> </paragraph> <paragraph num="(v)"> <text>Storage; or</text> </paragraph> <paragraph num="(vi)"> <text>Distribution.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Food processing plant” includes a:</text> <paragraph num="(i)"> <text>Crab meat picking plant;</text> </paragraph> <paragraph num="(ii)"> <text>Food manufacturing plant;</text> </paragraph> <paragraph num="(iii)"> <text>Cold food warehouse;</text> </paragraph> <paragraph num="(iv)"> <text>Ambient food warehouse, except as specified in §B(14)(c) of this regulation;</text> </paragraph> <paragraph num="(v)"> <text>Shellfish plant or dealer;</text> </paragraph> <paragraph num="(vi)"> <text>Bottled water plant;</text> </paragraph> <paragraph num="(vii)"> <text>Meat processing plant or poultry processing plant that is not subject to regulation by the United States Department of Agriculture or by a meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture;</text> </paragraph> <paragraph num="(viii)"> <text>Cider plant;</text> </paragraph> <paragraph num="(ix)"> <text>Charity deer processing plant; and</text> </paragraph> <paragraph num="(x)"> <text>Producer mobile farmer’s market unit.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Food processing plant” does not include a warehouse or distribution center that:</text> <paragraph num="(i)"> <text>Stores only sealed containers pre-packaged, ready-to-eat snack foods that do not require temperature control for safety;</text> </paragraph> <paragraph num="(ii)"> <text>Stores only bottled beverages that do not require temperature control for safety;</text> </paragraph> <paragraph num="(iii)"> <text>Stores only packaged ice;</text> </paragraph> <paragraph num="(iv)"> <text>Stores only whole bean, ground or instant coffee, or leaf or instant teas;</text> </paragraph> <paragraph num="(v)"> <text>Stores only nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or</text> </paragraph> <paragraph num="(vi)"> <text>Is a food transfer station where food is transferred between transportation vehicles or there is an area maintained for food that is stored for less than 24 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Generally recognized as safe (GRAS)” means that a substance is:</text> <paragraph num="(a)"> <text>Not harmful to humans consuming the substance under the intended conditions of use; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with 21 CFR §170.30.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Hazard” means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury</text> </paragraph> <paragraph num="(17)"> <text>“Hazard Analysis Critical Control Point (HACCP)” means a management system that addresses the safety of food that is temperature controlled for safety (TCS) at critical control points as specified by:</text> <paragraph num="(a)"> <text>COMAR 10.15.10 Procedures for the Safe Handling and Processing of Seafood;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.15.12 Procedures for the Safe Handling and Processing of Juice;</text> </paragraph> <paragraph num="(c)"> <text>21 CFR Part 123 Fish and Fishery Products; or</text> </paragraph> <paragraph num="(d)"> <text>The National Advisory Committee on the Microbiological Criteria for Food.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Indirect food additive” means a substance that is unintentionally incorporated into food due to processing, holding, or packaging.</text> </paragraph> <paragraph num="(19)"> <text>“Label” means a display of written or graphic matter on the container, other than the package liner, of a food.</text> </paragraph> <paragraph num="(20)"> <text>“Labeling” means any label or other written or graphic material that:</text> <paragraph num="(a)"> <text>Is on a:</text> <paragraph num="(i)"> <text>Food;</text> </paragraph> <paragraph num="(ii)"> <text>Food container; or</text> </paragraph> <paragraph num="(iii)"> <text>Food wrapping; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Accompanies a food.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Person-in-charge” means:</text> <paragraph num="(a)"> <text>The licensee; or</text> </paragraph> <paragraph num="(b)"> <text>Another person responsible for the operation of the food processing plant.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Potable water” means a water supply that meets the requirements of the Safe Drinking Water Act, as administered by the EPA and COMAR 26.04.02.01B(33).</text> </paragraph> <paragraph num="(24)"> <text>“Poultry” means any domesticated bird.</text> </paragraph> <paragraph num="(25)"> <text>Preventive Controls.</text> <paragraph num="(a)"> <text>“Preventive controls” means a step or combination of steps that are taken to minimize, prevent, or eliminate:</text> <paragraph num="(i)"> <text>Identified food safety hazards; or</text> </paragraph> <paragraph num="(ii)"> <text>Food safety hazards that are reasonably likely to occur.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Preventive controls” includes:</text> <paragraph num="(i)"> <text>Process controls;</text> </paragraph> <paragraph num="(ii)"> <text>Allergen controls;</text> </paragraph> <paragraph num="(iii)"> <text>Sanitation controls; and</text> </paragraph> <paragraph num="(iv)"> <text>Other appropriate controls taken at critical control points or at other points as necessary to ensure food safety based on the outcome of a hazard analysis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Preventive controls qualified individual (PCQI)” means an individual who has:</text> <paragraph num="(a)"> <text>Successfully completed training in the development and application of risk-based preventive controls; or</text> </paragraph> <paragraph num="(b)"> <text>The education, experience, and knowledge to develop and implement a food safety system.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Principal display panel” means the part of a label that is the most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.</text> </paragraph> <paragraph num="(28)"> <text>“Process” means a specific set of operations or procedures used to manufacture a food.</text> </paragraph> <paragraph num="(29)"> <text>“Process authority” means an individual having expert knowledge of specialized food processes acquired through :</text> <paragraph num="(a)"> <text>Training; and</text> </paragraph> <paragraph num="(b)"> <text>Experience.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>Producer Mobile Farmer’s Market Unit.</text> <paragraph num="(a)"> <text>“Producer mobile farmer’s market unit” means a unit designed to ensure that food is:</text> <paragraph num="(i)"> <text>Protected from contamination during transportation from farm to farmer’s market or public festival or event; and</text> </paragraph> <paragraph num="(ii)"> <text>Kept at temperatures that support the safety and wholesomeness of the food.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Producer mobile farmer’s market unit” does not include a unit used to deliver:</text> <paragraph num="(i)"> <text>Prepackaged foods to fill an order of a customer;</text> </paragraph> <paragraph num="(ii)"> <text>Raw agricultural products; or</text> </paragraph> <paragraph num="(iii)"> <text>On-farm home processed foods that do not require temperature control for safety.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Qualified auditor” means a qualified individual with necessary technical expertise regarding hazards being controlled to evaluate food safety regulations and review a supplier’s written plan, for example, the Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan, and its implementation through:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training; or</text> </paragraph> <paragraph num="(c)"> <text>Experience.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Qualified individual” means a person who is able to handle food safely as appropriate to the individual’s assigned duties, as determined by having the:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training; or</text> </paragraph> <paragraph num="(c)"> <text>Experience.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Scheduled process means a method or set of procedures established by a process authority for processing a food, includes the critical factors that may impact the food’s safety or stability to achieve and maintain a food that will not permit the growth of microorganisms having public health significance.</text> </paragraph> <paragraph num="(34)"> <text>“Shelf life study” means a food evaluation using microbiological, physical, chemical, organoleptic, or other tests to determine the length of time a food may be stored before the food becomes unfit for sale or human consumption.</text> </paragraph> <paragraph num="(35)"> <text>“Shell eggs” means raw or treated eggs produced by poultry for human consumption.</text> </paragraph> <paragraph num="(36)"> <text>“Snack foods” means chips, pretzels, candy, and other novelty snacks.</text> </paragraph> <paragraph num="(37)"> <text>“Temperature control for safety (TCS)” means a food requires specific time and temperature control to limit pathogenic microorganism growth or toxin formation for safety.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>9 CFR, as amended;</text> </paragraph> <paragraph num="(2)"> <text>21 CFR, as amended;</text> </paragraph> <paragraph num="(3)"> <text>21 U.S.C. §343, as amended;</text> </paragraph> <paragraph num="(4)"> <text>21 U.S.C. §§451 — 471, as amended; and</text> </paragraph> <paragraph num="(5)"> <text>21 U.S.C. §§601 — 695, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Compliance with Other Chapters."> <text>The person-in-charge shall manufacture, process, pack/repack, label, store, or distribute food and design, operate, and maintain a food processing plant and the facilities and equipment associated with a food processing plant in compliance with this chapter and with COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12, as applicable.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Personnel."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Individuals do not cause contamination of:</text> <paragraph num="(1)"> <text>Food;</text> </paragraph> <paragraph num="(2)"> <text>Food-contact surfaces; and</text> </paragraph> <paragraph num="(3)"> <text>Food-packaging material;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individuals are excluded from working with food, food-contact surfaces, and food-packaging materials:</text> <paragraph num="(1)"> <text>As provided in COMAR 10.06.01.06E; and</text> </paragraph> <paragraph num="(2)"> <text>When an individual has an:</text> <paragraph num="(a)"> <text>Illness transmissible through food; or</text> </paragraph> <paragraph num="(b)"> <text>Exposed and open sore or cut;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Individuals working in direct contact with food, food-contact surfaces, and food-packaging material:</text> <paragraph num="(1)"> <text>Wear suitable, clean outerwear garments in a manner that protects the food, food-contact surfaces, and food-packaging material against contamination;</text> </paragraph> <paragraph num="(2)"> <text>Wear hair nets, beard covers, or other effective hair restraints;</text> </paragraph> <paragraph num="(3)"> <text>Keep fingernails clean and neatly trimmed;</text> </paragraph> <paragraph num="(4)"> <text>Prevent fingernail polish or artificial fingernails from coming into contact with food, food-contact surfaces, and food-packaging material;</text> </paragraph> <paragraph num="(5)"> <text>Remove all unsecured jewelry and other objects that may fall into food, equipment, or containers;</text> </paragraph> <paragraph num="(6)"> <text>Secure any jewelry that cannot be removed with material which can be maintained in an intact, clean, and sanitary condition;</text> </paragraph> <paragraph num="(7)"> <text>Wash hands and exposed arm areas thoroughly with soap and warm water:</text> <paragraph num="(a)"> <text>At a hand washing facility in compliance with regulation .12G of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Before starting work;</text> </paragraph> <paragraph num="(c)"> <text>After each absence from the workstation; and</text> </paragraph> <paragraph num="(d)"> <text>At any other time when hands may have become soiled or contaminated or as often as required to remove soil and contamination; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Apply sanitizer as necessary to protect against contamination with undesirable microorganisms;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Individuals wearing gloves while working with food or food-contact surfaces shall:</text> <paragraph num="(1)"> <text>Use gloves that are intended for food contact;</text> </paragraph> <paragraph num="(2)"> <text>Maintain gloves in an intact, clean, and sanitary condition;</text> </paragraph> <paragraph num="(3)"> <text>Wash hands thoroughly before putting on gloves;</text> </paragraph> <paragraph num="(4)"> <text>Clean and sanitize reusable gloves using approved methods or equipment.</text> </paragraph> <paragraph num="(5)"> <text>Replace gloves:</text> <paragraph num="(a)"> <text>When the gloves are damaged or soiled;</text> </paragraph> <paragraph num="(b)"> <text>Between unrelated tasks; and</text> </paragraph> <paragraph num="(c)"> <text>After an interruption in working with food or food-contact surfaces;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Individuals store personal items in a designated area other than where food is exposed or stored, or where equipment or utensils are washed;</text> </paragraph> <paragraph num="F."> <text>Individuals do not use tobacco, chew gum, eat food, drink beverages, or engage in any activity that might contaminate food in an area that is used for:</text> <paragraph num="(1)"> <text>Food processing;</text> </paragraph> <paragraph num="(2)"> <text>Equipment or utensil washing;</text> </paragraph> <paragraph num="(3)"> <text>Storage of:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Food-contact surfaces; or</text> </paragraph> <paragraph num="(c)"> <text>Food packaging;</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Individuals prevent allergen cross-contact and contamination with microorganisms, deleterious substances, or foreign matter of food, food-contact surfaces, and food-packaging materials;</text> </paragraph> <paragraph num="H."> <text>Education and training in personal hygiene, food handling, and plant sanitation is provided to personnel, food handlers, and supervisors in a language and form they understand as it relates to assigned duties such that:</text> <paragraph num="(1)"> <text>Each individual engaged in food handling or in the supervision of one or more individuals be qualified by:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training;</text> </paragraph> <paragraph num="(c)"> <text>Experience; or</text> </paragraph> <paragraph num="(d)"> <text>A combination of education, training, and experience;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Responsibility for education and training shall be clearly assigned to qualified supervisory personnel; and</text> </paragraph> <paragraph num="(3)"> <text>Records that document each individual’s training are maintained according to Regulation .06 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="I."> <text>When specialized personnel training is required by COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, or 10.15.12 or this chapter, or 21 CFR Part 112, Subpart M, the specialized training is obtained as required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="General Record Keeping."> <text>The person-in-charge shall ensure that all required records:</text> <paragraph num="A."> <text>Be kept as original records, true copies, or electronic records;</text> </paragraph> <paragraph num="B."> <text>Identify the name and location of the food processing plant;</text> </paragraph> <paragraph num="C."> <text>Contain the time and date the activity was performed and documented;</text> </paragraph> <paragraph num="D."> <text>Include the signature or initials of the individual performing and documenting the activity;</text> </paragraph> <paragraph num="E."> <text>Contain actual values and observations obtained during monitoring and verification activities;</text> </paragraph> <paragraph num="F."> <text>Be accurate, indelible, and legible;</text> </paragraph> <paragraph num="G."> <text>Be created concurrently with performance of the activity documented;</text> </paragraph> <paragraph num="H."> <text>Be as detailed as necessary to provide a history of work performed;</text> </paragraph> <paragraph num="I."> <text>Identify the product and lot code if applicable;</text> </paragraph> <paragraph num="J."> <text>Are original or accurate reproductions of the original and are retained at the plant or facility for at least 2 years after the date they were prepared; and</text> </paragraph> <paragraph num="K."> <text>Are made available to an authorized representative of the Department for official review and reproduction upon oral or written request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Food Protection, Processes, and Controls."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>All food and food ingredients processed in a food processing plant:</text> <paragraph num="(1)"> <text>Are from an approved source;</text> </paragraph> <paragraph num="(2)"> <text>Are GRAS;</text> </paragraph> <paragraph num="(3)"> <text>If applicable, conform to a standard of identity, as defined in 21 CFR Part 130;</text> </paragraph> <paragraph num="(4)"> <text>Comply with FDA regulations for poisonous or deleterious substances; and</text> </paragraph> <paragraph num="(5)"> <text>Are identified and held in a manner that prevents allergen cross-contact if the food and food ingredients are an allergen or contain an allergen;</text> </paragraph> </paragraph> <paragraph num="B."> <text>When ice is used in contact with food, it shall be:</text> <paragraph num="(1)"> <text>Made from potable water; and</text> </paragraph> <paragraph num="(2)"> <text>Manufactured and stored in accordance with this chapter;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives;</text> </paragraph> <paragraph num="D."> <text>Raw materials and other ingredients:</text> <paragraph num="(1)"> <text>Are inspected at receipt to ensure that they are acceptable for use; and</text> </paragraph> <paragraph num="(2)"> <text>Are washed or cleaned as necessary to remove soil or other contamination;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Food is processed and stored under conditions and control procedures that prevent and protect from:</text> <paragraph num="(1)"> <text>Contamination; and</text> </paragraph> <paragraph num="(2)"> <text>Allergen cross-contact;</text> </paragraph> </paragraph> <paragraph num="F."> <text>The potential for contamination and allergen cross-contact is reduced by:</text> <paragraph num="(1)"> <text>Food safety controls;</text> </paragraph> <paragraph num="(2)"> <text>Operating practices; and</text> </paragraph> <paragraph num="(3)"> <text>Separation of operations by:</text> <paragraph num="(a)"> <text>Location;</text> </paragraph> <paragraph num="(b)"> <text>Time; or</text> </paragraph> <paragraph num="(c)"> <text>Effective design;</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Food is processed and stored at temperatures that:</text> <paragraph num="(1)"> <text>Minimize the potential for the growth of microorganisms; and</text> </paragraph> <paragraph num="(2)"> <text>Prevent adulteration;</text> </paragraph> </paragraph> <paragraph num="H."> <text>The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption;</text> </paragraph> <paragraph num="I."> <text>The cooling of foods is conducted using methods that:</text> <paragraph num="(1)"> <text>Minimize the potential for the growth of microorganisms; and</text> </paragraph> <paragraph num="(2)"> <text>Prevent adulteration;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Foods that require temperature control for safety are maintained at the temperature:</text> <paragraph num="(1)"> <text>38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard;</text> </paragraph> <paragraph num="(2)"> <text>40°F or less;</text> </paragraph> <paragraph num="(3)"> <text>45°F or less for molluscan shellfish or shell eggs;</text> </paragraph> <paragraph num="(4)"> <text>135°F or higher; or</text> </paragraph> <paragraph num="(5)"> <text>As otherwise approved by the Department;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Food that relies principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level;</text> </paragraph> <paragraph num="L."> <text>Food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below;</text> </paragraph> <paragraph num="M."> <text>Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food;</text> </paragraph> <paragraph num="N."> <text>Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved;</text> </paragraph> <paragraph num="O."> <text>Frozen foods are thawed in a manner that prevents contamination;</text> </paragraph> <paragraph num="P."> <text>Any food, raw material, or ingredient that is adulterated is not offered to human beings and is:</text> <paragraph num="(1)"> <text>Rejected upon receipt;</text> </paragraph> <paragraph num="(2)"> <text>Treated or processed to eliminate the contamination;</text> </paragraph> <paragraph num="(3)"> <text>Destroyed in a manner that protects against the contamination and allergen cross-contact of other food;</text> </paragraph> <paragraph num="(4)"> <text>Stored only in a designated area that is:</text> <paragraph num="(a)"> <text>Separated from all other food and food process operations; and</text> </paragraph> <paragraph num="(b)"> <text>Conspicuously marked with the intended disposition;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Reconditioned using a method that is safe and effective;</text> </paragraph> <paragraph num="(6)"> <text>Reexamined following reconditioning and subsequently found not to be adulterated;</text> </paragraph> <paragraph num="(7)"> <text>Not mixed with another lot of food that is not adulterated; and</text> </paragraph> <paragraph num="(8)"> <text>If detained by the Department:</text> <paragraph num="(a)"> <text>Reconditioned; or</text> </paragraph> <paragraph num="(b)"> <text>Destroyed in a manner approved by the Department;</text> </paragraph> </paragraph> </paragraph> <paragraph num="Q."> <text>A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens:</text> <paragraph num="(1)"> <text>Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens;</text> </paragraph> <paragraph num="(2)"> <text>Monitors the temperature controls with adequate frequency;</text> </paragraph> <paragraph num="(3)"> <text>Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food;</text> </paragraph> <paragraph num="(4)"> <text>Establishes and maintains affirmative or exception records that document implementation of temperature controls, calibration, or accuracy checks of temperature monitoring and recording devices, and corrective actions;</text> </paragraph> <paragraph num="(5)"> <text>Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within:</text> <paragraph num="(a)"> <text>7 working days after the records are created; or</text> </paragraph> <paragraph num="(b)"> <text>A reasonable time frame; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created;</text> </paragraph> </paragraph> <paragraph num="R."> <text>Written standard operating procedures are:</text> <paragraph num="(1)"> <text>Available to employees in a format they understand;</text> </paragraph> <paragraph num="(2)"> <text>Implemented; and</text> </paragraph> <paragraph num="(3)"> <text>Reflective of current manufacturing procedures;</text> </paragraph> </paragraph> <paragraph num="S."> <text>When the Department requires a scheduled process, the scheduled process is:</text> <paragraph num="(1)"> <text>Established by a process authority;</text> </paragraph> <paragraph num="(2)"> <text>Used to manufacture the target food;</text> </paragraph> <paragraph num="(3)"> <text>Not changed without approval of the process authority;</text> </paragraph> <paragraph num="(4)"> <text>Documented by:</text> <paragraph num="(a)"> <text>Production records; and</text> </paragraph> <paragraph num="(b)"> <text>Process deviation records; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Verified by:</text> <paragraph num="(a)"> <text>Production records review;</text> </paragraph> <paragraph num="(b)"> <text>Equipment calibration; or</text> </paragraph> <paragraph num="(c)"> <text>Laboratory testing;</text> </paragraph> </paragraph> </paragraph> <paragraph num="T."> <text>Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="U."> <text>Human food by-products for use or distribution as animal food without additional manufacturing or processing are:</text> <paragraph num="(1)"> <text>Accurately identified when stored;</text> </paragraph> <paragraph num="(2)"> <text>Stored under conditions that protect against contamination; and</text> </paragraph> <paragraph num="(3)"> <text>Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed;</text> </paragraph> </paragraph> <paragraph num="V."> <text>Finished product testing for chemicals, microbes, or extraneous materials is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact; and</text> </paragraph> <paragraph num="W."> <text>Environmental testing for chemicals or microbes is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Hazard Analysis and Risk-Based Preventive Controls."> <text>The person-in-charge:</text> <paragraph num="A."> <text>Is exempt from this regulation if:</text> <paragraph num="(1)"> <text>They meet the definition of a qualified facility in 21 CFR §117.3; or</text> </paragraph> <paragraph num="(2)"> <text>They meet the qualifications defined in:</text> <paragraph num="(a)"> <text>21 CFR §§117.5—117.8;</text> </paragraph> <paragraph num="(b)"> <text>21 CFR §117.201;</text> </paragraph> <paragraph num="(c)"> <text>21 CFR §§117.251—117.287; and</text> </paragraph> <paragraph num="(d)"> <text>21 CFR §117.315(a)(2);</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Shall ensure that a food safety plan:</text> <paragraph num="(1)"> <text>Is prepared, implemented, and managed by one or more individuals qualified in preventative controls;</text> </paragraph> <paragraph num="(2)"> <text>Is signed and dated by the owner, operator, or agent in charge:</text> <paragraph num="(a)"> <text>Upon initial completion;</text> </paragraph> <paragraph num="(b)"> <text>When any modification takes place; and</text> </paragraph> <paragraph num="(c)"> <text>At least once every 3 years;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant;</text> </paragraph> <paragraph num="(4)"> <text>Includes written procedures for:</text> <paragraph num="(a)"> <text>Preventive controls;</text> </paragraph> <paragraph num="(b)"> <text>Process controls with parameters and values;</text> </paragraph> <paragraph num="(c)"> <text>Allergen controls;</text> </paragraph> <paragraph num="(d)"> <text>Sanitation controls;</text> </paragraph> <paragraph num="(e)"> <text>Other controls necessary as identified in the hazard analysis;</text> </paragraph> <paragraph num="(f)"> <text>Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard;</text> </paragraph> <paragraph num="(g)"> <text>Corrective actions that:</text> <paragraph num="(i)"> <text>Identify and correct the problem;</text> </paragraph> <paragraph num="(ii)"> <text>Reduce the likelihood the problem will recur;</text> </paragraph> <paragraph num="(iii)"> <text>Evaluate all affected food for safety; and</text> </paragraph> <paragraph num="(iv)"> <text>Prevent all affected food from entering commerce;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards;</text> </paragraph> <paragraph num="(i)"> <text>Validation for process controls;</text> </paragraph> <paragraph num="(j)"> <text>A supply chain program that complies with 21 CFR §§117.405—117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and</text> </paragraph> <paragraph num="(k)"> <text>A recall plan for a food with a hazard requiring a preventive control, that includes:</text> <paragraph num="(i)"> <text>Maintaining accurate records to identify the initial distribution of the food;</text> </paragraph> <paragraph num="(ii)"> <text>Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food;</text> </paragraph> <paragraph num="(iii)"> <text>Public notification about any hazard presented by the food when appropriate to protect public health; and</text> </paragraph> <paragraph num="(iv)"> <text>Effectiveness checks to account for all products affected;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards;</text> </paragraph> <paragraph num="(6)"> <text>Includes records that document implementation of:</text> <paragraph num="(a)"> <text>The food safety plan monitoring;</text> </paragraph> <paragraph num="(b)"> <text>Corrective actions; and</text> </paragraph> <paragraph num="(c)"> <text>Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and</text> </paragraph> <paragraph num="(8)"> <text>Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall ensure that a processing plant complies with the 21 CFR §§117.136—117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Plant and Grounds."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The food processing plant and grounds around a food processing plant are:</text> <paragraph num="(1)"> <text>Maintained free of attractants, breeding places, or harborage for pests and insects, including:</text> <paragraph num="(a)"> <text>Unused equipment;</text> </paragraph> <paragraph num="(b)"> <text>Debris;</text> </paragraph> <paragraph num="(c)"> <text>Litter;</text> </paragraph> <paragraph num="(d)"> <text>Waste; or</text> </paragraph> <paragraph num="(e)"> <text>High weeds or grass; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Adequately drained to promote sanitation and prevent breeding places for pests and insects;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The design and construction of the plant facilitates maintenance and sanitary operations for food processing and:</text> <paragraph num="(1)"> <text>Is suitable in size;</text> </paragraph> <paragraph num="(2)"> <text>Affords protection against the weather; and</text> </paragraph> <paragraph num="(3)"> <text>Minimizes the potential for contamination and allergen cross-contact by providing:</text> <paragraph num="(a)"> <text>Adequate space for the placement of:</text> <paragraph num="(i)"> <text>Equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Utensils; and</text> </paragraph> <paragraph num="(iii)"> <text>Materials storage; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Effective designing the flow of food through the plant;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided for in Regulation .15 of this chapter, a room or area in which food is processed or stored or in which utensils, equipment, or food-packaging materials are cleaned, sanitized, or stored:</text> <paragraph num="(1)"> <text>Is separated from other rooms or areas in the plant to preclude allergen cross-contact and contamination by:</text> <paragraph num="(a)"> <text>A distance that precludes allergen cross-contact and contamination; or</text> </paragraph> <paragraph num="(b)"> <text>Tight fitting:</text> <paragraph num="(i)"> <text>Walls;</text> </paragraph> <paragraph num="(ii)"> <text>Ceilings; and</text> </paragraph> <paragraph num="(iii)"> <text>Self-closing doors;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is, if not refrigerated, mechanically ventilated using exhaust and supply fans to ensure:</text> <paragraph num="(a)"> <text>Filtered air is supplied to provide a positive air pressure in the room;</text> </paragraph> <paragraph num="(b)"> <text>Condensation and grease do not accumulate on room surfaces and equipment; and</text> </paragraph> <paragraph num="(c)"> <text>Removal of excessive:</text> <paragraph num="(i)"> <text>Grease vapors;</text> </paragraph> <paragraph num="(ii)"> <text>Steam;</text> </paragraph> <paragraph num="(iii)"> <text>Heat; and</text> </paragraph> <paragraph num="(iv)"> <text>Odors;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Has a floor, walls, and ceiling that are:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Washable;</text> </paragraph> <paragraph num="(c)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(d)"> <text>Impervious to water;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has only the exposed overhead pipes, ducts, conduits, evaporators, and other structures that are needed for proper processing, which are installed so that food is protected against leakage;</text> </paragraph> <paragraph num="(5)"> <text>Has floor-wall junctures that are:</text> <paragraph num="(a)"> <text>Coved; and</text> </paragraph> <paragraph num="(b)"> <text>Impervious to water;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has aisles or working spaces between equipment and walls that:</text> <paragraph num="(a)"> <text>Are unobstructed;</text> </paragraph> <paragraph num="(b)"> <text>Of adequate width to permit employees to perform their duties; and</text> </paragraph> <paragraph num="(c)"> <text>Protect against the contamination of food, food-contact surfaces, or food-packaging materials by clothing or personal contact;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Provides adequate lighting in all areas that:</text> <paragraph num="(a)"> <text>Uses shatter-resistant light bulbs, fixtures, skylights, or other light sources if suspended over exposed food, food-contact surfaces, or food-packaging materials in any step of preparation; or</text> </paragraph> <paragraph num="(b)"> <text>Otherwise protects against food contamination in case of glass breakage; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Has well-maintained, sealed walls, floors, and ceilings to prevent entry or harborage areas for pests;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except as provided for in Regulation .15 of this chapter, an area is designated for employees to eat, drink, and securely store personal items which is separate from areas designated for the cleaning, sanitation, or storage of:</text> <paragraph num="(1)"> <text>Utensils;</text> </paragraph> <paragraph num="(2)"> <text>Equipment; or</text> </paragraph> <paragraph num="(3)"> <text>Food-packaging materials;</text> </paragraph> </paragraph> <paragraph num="E."> <text>The food processing plant is completely separated by solid, impervious floors, walls, and ceilings with no connecting openings from areas used as living quarters; and</text> </paragraph> <paragraph num="F."> <text>Plans provided for review to the Department of the plant, facilities, and grounds design and construction that are not provided for in this regulation:</text> <paragraph num="(1)"> <text>Provide for adequate food safety, food protection, and sanitation; and</text> </paragraph> <paragraph num="(2)"> <text>Are equivalent to regulatory and industry standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Equipment and Utensils."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Except as provided in §§B and M of this regulation, equipment and utensils meet one or more of the following sanitation design standards:</text> <paragraph num="(1)"> <text>National Sanitation Foundation (NSF);</text> </paragraph> <paragraph num="(2)"> <text>The ETL SEMKO division of Intertek Group PLC (Intertek ETL SEMKO);</text> </paragraph> <paragraph num="(3)"> <text>Canadian Standards Association (CSA);</text> </paragraph> <paragraph num="(4)"> <text>Underwriters Laboratories (UL);</text> </paragraph> <paragraph num="(5)"> <text>Bakery Industry Sanitation Standards Committee;</text> </paragraph> <paragraph num="(6)"> <text>National Automatic Merchandising Association;</text> </paragraph> <paragraph num="(7)"> <text>International Association of Food Protection;</text> </paragraph> <paragraph num="(8)"> <text>American Society of Mechanical Engineers;</text> </paragraph> <paragraph num="(9)"> <text>U.S. Department of Agriculture; or</text> </paragraph> <paragraph num="(10)"> <text>Another applicable published standard acceptable to the Department;</text> </paragraph> </paragraph> <paragraph num="B."> <text>When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed;</text> </paragraph> <paragraph num="C."> <text>Food processing equipment and utensils are:</text> <paragraph num="(1)"> <text>Designed and constructed to allow for adequate cleaning and sanitizing;</text> </paragraph> <paragraph num="(2)"> <text>Installed in a way to facilitate cleaning, sanitizing, and maintenance of the equipment and the surrounding areas, including equipment that does not come in contact with food;</text> </paragraph> <paragraph num="(3)"> <text>Designed and constructed to prevent contamination and allergen cross-contact; and</text> </paragraph> <paragraph num="(4)"> <text>Maintained in:</text> <paragraph num="(a)"> <text>Proper working condition; and</text> </paragraph> <paragraph num="(b)"> <text>A manner that protects against contamination and allergen cross-contact;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Each freezer and cold storage unit used to store and transport food capable of supporting growth of microorganisms:</text> <paragraph num="(1)"> <text>Maintains temperatures that ensure food safety and protect against spoilage;</text> </paragraph> <paragraph num="(2)"> <text>Is fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that is:</text> <paragraph num="(a)"> <text>Calibrated to be accurate to within plus or minus 2°F; and</text> </paragraph> <paragraph num="(b)"> <text>Placed in a conspicuous location to show the temperature accurately within the unit;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>All food-contact surfaces are designed, constructed, and maintained to be:</text> <paragraph num="(1)"> <text>Smooth;</text> </paragraph> <paragraph num="(2)"> <text>Easily cleanable;</text> </paragraph> <paragraph num="(3)"> <text>Durable;</text> </paragraph> <paragraph num="(4)"> <text>Non-absorbent;</text> </paragraph> <paragraph num="(5)"> <text>Constructed of food grade material where applicable;</text> </paragraph> <paragraph num="(6)"> <text>Corrosion resistant;</text> </paragraph> <paragraph num="(7)"> <text>Made of nontoxic material that does not impart toxic or deleterious matter to the food;</text> </paragraph> <paragraph num="(8)"> <text>Inert to food and do not migrate into or adulterate food; and</text> </paragraph> <paragraph num="(9)"> <text>Smoothly bonded at the seams and maintained to minimize accumulation of:</text> <paragraph num="(a)"> <text>Food particles;</text> </paragraph> <paragraph num="(b)"> <text>Dirt; and</text> </paragraph> <paragraph num="(c)"> <text>Organic matter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Food-packaging material:</text> <paragraph num="(1)"> <text>Is food grade;</text> </paragraph> <paragraph num="(2)"> <text>Is safe;</text> </paragraph> <paragraph num="(3)"> <text>Is able to maintain food safety and integrity;</text> </paragraph> <paragraph num="(4)"> <text>Is appropriate for the food item and the intended use;</text> </paragraph> <paragraph num="(5)"> <text>Is not reused if intended for single-service;</text> </paragraph> <paragraph num="(6)"> <text>Meets the labeling requirements in Regulation .13B(2) of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Does not migrate to or have the potential to be absorbed by food; and</text> </paragraph> <paragraph num="(8)"> <text>Complies with the requirements of the U.S. Food and Drug Administration in 21 CFR Parts 174—178 for indirect food additives;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Instruments and controls required for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food are accurate and adequate in number for their designated uses;</text> </paragraph> <paragraph num="H."> <text>Thermometers used to monitor required temperatures are calibrated or checked for accuracy annually using an approved method;</text> </paragraph> <paragraph num="I."> <text>Compressed air or other gasses mechanically used to clean food-contact surfaces or equipment are treated in such a way that food is not contaminated with unlawful indirect food additives;</text> </paragraph> <paragraph num="J."> <text>Non-food-contact equipment is:</text> <paragraph num="(1)"> <text>Smooth;</text> </paragraph> <paragraph num="(2)"> <text>Easily cleanable;</text> </paragraph> <paragraph num="(3)"> <text>Durable; and</text> </paragraph> <paragraph num="(4)"> <text>Non-absorbent;</text> </paragraph> </paragraph> <paragraph num="K."> <text>The food storage area of a transportation vehicle is maintained in:</text> <paragraph num="(1)"> <text>Good repair;</text> </paragraph> <paragraph num="(2)"> <text>Working condition; and</text> </paragraph> <paragraph num="(3)"> <text>A manner that protects against contamination of food;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food are designed and constructed of appropriate material to protect against contamination; and</text> </paragraph> <paragraph num="M."> <text>Equipment submitted to the approving authority for review that meets the provisions of §§C—E of this regulation but fails to comply with §A of this regulation is:</text> <paragraph num="(1)"> <text>Not harmful to public health; and</text> </paragraph> <paragraph num="(2)"> <text>Consistent with industry standards and practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Sanitary Operation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>All food processing, food storage, and food-packaging storage areas are maintained in a clean and sanitary manner;</text> </paragraph> <paragraph num="B."> <text>Equipment is used and maintained to avoid contamination and allergen cross-contact of food;</text> </paragraph> <paragraph num="C."> <text>Food-packaging material is stored to be protected from contamination;</text> </paragraph> <paragraph num="D."> <text>Overall sanitation of the plant is under the supervision of one or more qualified individuals;</text> </paragraph> <paragraph num="E."> <text>The equipment and facilities needed for cleaning and sanitizing food-contact surfaces are provided and maintained in a sanitary condition;</text> </paragraph> <paragraph num="F."> <text>Cleaning and sanitizing of plant facilities, equipment, and utensils are conducted in a manner that protects against allergen cross-contact and against contamination of:</text> <paragraph num="(1)"> <text>Food;</text> </paragraph> <paragraph num="(2)"> <text>Food-contact surfaces; and</text> </paragraph> <paragraph num="(3)"> <text>Food-packaging materials;</text> </paragraph> </paragraph> <paragraph num="G."> <text>All food-contact surfaces are cleaned and sanitized as frequently as necessary to protect against allergen cross-contact and against contamination of food;</text> </paragraph> <paragraph num="H."> <text>Before use, food-contact surfaces used for processing or holding low-moisture food are:</text> <paragraph num="(1)"> <text>Clean;</text> </paragraph> <paragraph num="(2)"> <text>Dry; and</text> </paragraph> <paragraph num="(3)"> <text>Sanitary;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Food-contact surfaces are cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated;</text> </paragraph> <paragraph num="J."> <text>When equipment and utensils are washed, rinsed, and sanitized using a three-compartment sink:</text> <paragraph num="(1)"> <text>Each sink compartment is sized to allow sufficient immersion of the equipment or utensils; and</text> </paragraph> <paragraph num="(2)"> <text>The washed, rinsed, and sanitized items are dry before stacking or nesting;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Non-food-contact surfaces of equipment used in the operation of a food plant are cleaned as frequently as necessary to be maintained in a sanitary condition;</text> </paragraph> <paragraph num="L."> <text>Cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils;</text> </paragraph> <paragraph num="M."> <text>Toxic chemicals, cleaning compounds, sanitizing agents, and pesticide chemicals used in the facility are:</text> <paragraph num="(1)"> <text>Safe and adequate under the conditions of use;</text> </paragraph> <paragraph num="(2)"> <text>Used in accordance with the manufacturer’s instructions and applicable State laws and regulations; and</text> </paragraph> <paragraph num="(3)"> <text>Identified and stored in a manner that protects against contaminating:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Food-contact surfaces; or</text> </paragraph> <paragraph num="(c)"> <text>Food-packaging materials;</text> </paragraph> </paragraph> </paragraph> <paragraph num="N."> <text>All processing and storage areas are maintained free of pests;</text> </paragraph> <paragraph num="O."> <text>Effective measures are taken to:</text> <paragraph num="(1)"> <text>Monitor for and exclude pests from processing and storage areas; and</text> </paragraph> <paragraph num="(2)"> <text>Protect against the contamination of food by pests;</text> </paragraph> </paragraph> <paragraph num="P."> <text>The food storage area of a transportation vehicle is:</text> <paragraph num="(1)"> <text>Maintained in a clean and sanitary condition; and</text> </paragraph> <paragraph num="(2)"> <text>Inspected as often as necessary to maintain it in a clean and sanitary condition;</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food before distribution are:</text> <paragraph num="(1)"> <text>Cleaned as necessary;</text> </paragraph> <paragraph num="(2)"> <text>Examined prior to use to protect against contamination from the container or vehicle; and</text> </paragraph> <paragraph num="(3)"> <text>Maintained to protect against contamination; and</text> </paragraph> </paragraph> <paragraph num="R."> <text>If ready-to-eat foods are processed, environmental testing is conducted when necessary to demonstrate effectiveness of sanitation operations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Sanitary Facilities and Controls."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The water supply is adequate for the operations intended and is:</text> <paragraph num="(1)"> <text>From an approved potable source;</text> </paragraph> <paragraph num="(2)"> <text>At an adequate temperature;</text> </paragraph> <paragraph num="(3)"> <text>Under adequate pressure; and</text> </paragraph> <paragraph num="(4)"> <text>Protected against backflow;</text> </paragraph> </paragraph> <paragraph num="B."> <text>All plumbing is of adequate size and is designed, installed, and maintained to:</text> <paragraph num="(1)"> <text>Carry adequate quantities of water to required locations throughout the plant;</text> </paragraph> <paragraph num="(2)"> <text>Convey sewage and liquid waste from the plant;</text> </paragraph> <paragraph num="(3)"> <text>Prevent contamination of:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Water supplies;</text> </paragraph> <paragraph num="(c)"> <text>Equipment;</text> </paragraph> <paragraph num="(d)"> <text>Utensils; and</text> </paragraph> <paragraph num="(e)"> <text>Food-packaging materials;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ensure sanitary conditions;</text> </paragraph> <paragraph num="(5)"> <text>Prevent backflow from, or cross-connection between, piping systems that carry wastewater and potable water; and</text> </paragraph> <paragraph num="(6)"> <text>Be in compliance with State and local codes;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Adequate floor drainage is provided in all areas where:</text> <paragraph num="(1)"> <text>Floors are subject to water accumulation during cleaning; or</text> </paragraph> <paragraph num="(2)"> <text>Normal operations release or discharge water or other liquid waste on the floor;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Floors are sloped to floor drains to prevent water accumulation and ponding;</text> </paragraph> <paragraph num="E."> <text>Sewage and wastewater is discharged:</text> <paragraph num="(1)"> <text>In compliance with applicable laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Into a sewage disposal system that meets all applicable State and local codes; or</text> </paragraph> <paragraph num="(3)"> <text>Through other acceptable means approved by the Department;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Toilet facilities:</text> <paragraph num="(1)"> <text>Are readily accessible and adequate in number for employee use;</text> </paragraph> <paragraph num="(2)"> <text>Are kept clean and are not a potential source of contamination of:</text> <paragraph num="(a)"> <text>Food;</text> </paragraph> <paragraph num="(b)"> <text>Food-contact surfaces; and</text> </paragraph> <paragraph num="(c)"> <text>Food-packaging materials; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Are provided with:</text> <paragraph num="(a)"> <text>Signage that instructs individuals to wash their hands before returning to work;</text> </paragraph> <paragraph num="(b)"> <text>Mechanical air exhaust and intake of an equal amount of makeup air at the rate of 2 cubic feet per minute of air for each square foot of floor area or a screened window that allows the adequate exchange of outside air;</text> </paragraph> <paragraph num="(c)"> <text>Floors, walls, and a ceiling that are:</text> <paragraph num="(i)"> <text>Smooth;</text> </paragraph> <paragraph num="(ii)"> <text>Washable;</text> </paragraph> <paragraph num="(iii)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(iv)"> <text>Impervious to water;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Floor-wall junctures that are sealed to be impervious to water;</text> </paragraph> <paragraph num="(e)"> <text>Adequate lighting; and</text> </paragraph> <paragraph num="(f)"> <text>Hand washing facilities as specified in §G of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Hand washing facilities:</text> <paragraph num="(1)"> <text>Are provided that are adequate in number and conveniently located in areas where food is processed or equipment or utensils are washed and sanitized; and</text> </paragraph> <paragraph num="(2)"> <text>Are supplied with:</text> <paragraph num="(a)"> <text>Soap;</text> </paragraph> <paragraph num="(b)"> <text>Warm water of sufficient volume, under pressure for effective hand washing;</text> </paragraph> <paragraph num="(c)"> <text>Paper towels or warm air hand drying device;</text> </paragraph> <paragraph num="(d)"> <text>A conveniently located trash receptacle; and</text> </paragraph> <paragraph num="(e)"> <text>Hand sanitizer, if necessary to protect against contamination; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Solid waste:</text> <paragraph num="(1)"> <text>Is handled and disposed of using waste containers that are:</text> <paragraph num="(a)"> <text>Adequate in number and size to maintain sanitary conditions;</text> </paragraph> <paragraph num="(b)"> <text>Conveniently located where waste is generated;</text> </paragraph> <paragraph num="(c)"> <text>Easily cleanable;</text> </paragraph> <paragraph num="(d)"> <text>Leak proof; and</text> </paragraph> <paragraph num="(e)"> <text>Emptied and cleaned at a frequency that maintains sanitary conditions; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is handled, stored, and disposed of in a manner that:</text> <paragraph num="(a)"> <text>Minimizes the development of odors;</text> </paragraph> <paragraph num="(b)"> <text>Minimizes the potential for becoming an attractant or harborage for pests;</text> </paragraph> <paragraph num="(c)"> <text>Meets all applicable State and local codes; and</text> </paragraph> <paragraph num="(d)"> <text>Protects against contamination of:</text> <paragraph num="(i)"> <text>Food;</text> </paragraph> <paragraph num="(ii)"> <text>Food-contact surfaces;</text> </paragraph> <paragraph num="(iii)"> <text>Food-packaging materials;</text> </paragraph> <paragraph num="(iv)"> <text>Water supplies; and</text> </paragraph> <paragraph num="(v)"> <text>Plant and grounds.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Labeling."> <paragraph num="A."> <text>In accordance with Health-General Article, §21-212, Annotated Code of Maryland, a federal rule that exempts a food from label requirements is effective automatically in the State.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Except as provided in §A of this regulation, food labeling meets the requirements in 21 CFR Part 101;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §A of this regulation, the following information is provided on a label of food in packaged form:</text> <paragraph num="(a)"> <text>Common or usual name of the food;</text> </paragraph> <paragraph num="(b)"> <text>Statement of ingredients that gives the common or usual names of the ingredients in descending order of prominence with sub-ingredients listed;</text> </paragraph> <paragraph num="(c)"> <text>Name and address of the manufacturer or distributor with:</text> <paragraph num="(i)"> <text>The full street address including the zip code of the manufacturer or distributor if the address is not listed on a website, current city directory, or telephone directory; or</text> </paragraph> <paragraph num="(ii)"> <text>A minimum of the town and zip code if the manufacturer or distributor is listed on a website, current city directory, or telephone directory;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Net quantity in terms of:</text> <paragraph num="(i)"> <text>Weight in U.S. Customary units and equivalent metric units;</text> </paragraph> <paragraph num="(ii)"> <text>Fluid measure in U.S. Customary units and equivalent metric units;</text> </paragraph> <paragraph num="(iii)"> <text>Numerical count; or</text> </paragraph> <paragraph num="(iv)"> <text>Combination of numerical count and weight;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If a food coloring has been added, the food coloring in the statement of ingredients;</text> </paragraph> <paragraph num="(f)"> <text>If a chemical preservative has been added, a label declaration stating:</text> <paragraph num="(i)"> <text>The common or usual name of the ingredient; and</text> </paragraph> <paragraph num="(ii)"> <text>A separate description of its function such as “preservative” or “mold inhibitor”;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Major food allergens in accordance with 21 U.S.C. §343(w);</text> </paragraph> <paragraph num="(h)"> <text>For a food that requires refrigeration for safety, the words “keep refrigerated” or equivalent;</text> </paragraph> <paragraph num="(i)"> <text>For a food that requires refrigeration for safety after the food’s packaging is opened, the words “refrigerate after opening” or equivalent;</text> </paragraph> <paragraph num="(j)"> <text>For a food that is frozen for safety or quality, the words “keep frozen” or equivalent;</text> </paragraph> <paragraph num="(k)"> <text>A “use by date” if the package contains a food whose safety is assured only until the date specified on the label;</text> </paragraph> <paragraph num="(l)"> <text>For a food that is frozen during processing or after processing and then thawed before being offered for human consumption, the words “previously frozen, should not refreeze”; and</text> </paragraph> <paragraph num="(m)"> <text>The exact words “WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.” for a juice product that has not been processed in accordance with COMAR 10.15.12;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A food label and the labeling information in §B(1) of this regulation are:</text> <paragraph num="(a)"> <text>Durable;</text> </paragraph> <paragraph num="(b)"> <text>Conspicuous;</text> </paragraph> <paragraph num="(c)"> <text>Legible;</text> </paragraph> <paragraph num="(d)"> <text>Able to remain on a container for the shelf life of the food; and</text> </paragraph> <paragraph num="(e)"> <text>Placed on the food container by:</text> <paragraph num="(i)"> <text>Imprinting;</text> </paragraph> <paragraph num="(ii)"> <text>Embossing;</text> </paragraph> <paragraph num="(iii)"> <text>Lithography;</text> </paragraph> <paragraph num="(iv)"> <text>Ink jetting; or</text> </paragraph> <paragraph num="(v)"> <text>Another method set forth in 21 CFR Parts 100 and 101 or in conformance with §B(2) of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The information required in §B(2) of this regulation is located on the principal display panel;</text> </paragraph> <paragraph num="(5)"> <text>If the food is not manufactured by the business whose name appears on the label, the business name is qualified by a phrase that reveals the connection the business has with the food, such as “Manufactured for” or “Distributed by”;</text> </paragraph> <paragraph num="(6)"> <text>If the address given on the label is not the place where the food was actually manufactured, packaged, or distributed, it is the address of the principal place of business of the manufacturer or distributor given on the label;</text> </paragraph> <paragraph num="(7)"> <text>A food’s labeling or packaging is not false or misleading in any way; and</text> </paragraph> <paragraph num="(8)"> <text>A food that has been frozen or thermally processed is not labeled “fresh”.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge may forego:</text> <paragraph num="(1)"> <text>Declaring on the label the common or usual name of each ingredient for incidental additives that:</text> <paragraph num="(a)"> <text>Have no technical or functional effect in the food; and</text> </paragraph> <paragraph num="(b)"> <text>Are not required by a federal rule to be declared; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complying with the requirements in §B(2)(a)—(f) and (j) of this regulation for a shipment of food that, in accordance with the practice of trade, is processed, labeled, or repacked in substantial quantity at an establishment other than where originally processed or packed if:</text> <paragraph num="(a)"> <text>The person who introduced the shipment of food into interstate commerce is the operator of the establishment where the food is to be processed, labeled, or repacked; or</text> </paragraph> <paragraph num="(b)"> <text>The shipment or delivery to the establishment is made under a written agreement as set forth in 21 CFR §101.100(d).</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Facility Process and Plan Review."> <paragraph num="A."> <text>The person-in-charge shall ensure that plans and specifications are submitted to the Department:</text> <paragraph num="(1)"> <text>Before:</text> <paragraph num="(a)"> <text>A food processing plant is:</text> <paragraph num="(i)"> <text>Constructed;</text> </paragraph> <paragraph num="(ii)"> <text>Remodeled; or</text> </paragraph> <paragraph num="(iii)"> <text>Materially altered;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An existing building or structure is converted or remodeled for use as a food processing plant;</text> </paragraph> <paragraph num="(c)"> <text>A food or process is added or significantly modified; or</text> </paragraph> <paragraph num="(d)"> <text>A new scheduled process or shelf life study is used; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>That include the following information, as applicable:</text> <paragraph num="(a)"> <text>A scale drawing in horizontal view that identifies the:</text> <paragraph num="(i)"> <text>Layout and arrangement of work areas;</text> </paragraph> <paragraph num="(ii)"> <text>Location of food equipment including exhaust ventilation hoods; and</text> </paragraph> <paragraph num="(iii)"> <text>Location of plumbing and plumbing fixtures such as water lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks, floor drains, floor sinks, and hose stations;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Specifications for the:</text> <paragraph num="(i)"> <text>Construction materials for the building and interior finishes;</text> </paragraph> <paragraph num="(ii)"> <text>Disposal of sewage;</text> </paragraph> <paragraph num="(iii)"> <text>Provision of potable water;</text> </paragraph> <paragraph num="(iv)"> <text>Exclusion and control of pests;</text> </paragraph> <paragraph num="(v)"> <text>Ventilation of the plant and individual areas within the plant;</text> </paragraph> <paragraph num="(vi)"> <text>Methods and facilities for waste storage and disposal; and</text> </paragraph> <paragraph num="(vii)"> <text>Lighting;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A complete list of specifications for the proposed equipment;</text> </paragraph> <paragraph num="(d)"> <text>A written description of the foods to be processed, stored, or distributed;</text> </paragraph> <paragraph num="(e)"> <text>Written standard operating procedures for:</text> <paragraph num="(i)"> <text>Processing foods named in §A(2)(d) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Employee health and personal hygiene; and</text> </paragraph> <paragraph num="(iii)"> <text>Plant sanitation;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>When required by Regulation .02, .07, .10, or .12 of this chapter, a HACCP plan;</text> </paragraph> <paragraph num="(g)"> <text>When required by the Department, a scheduled process or shelf life study, performed by a process authority;</text> </paragraph> <paragraph num="(h)"> <text>When required by the Department, a laboratory analysis, performed by a laboratory with a current accreditation to the ISO/IEC 17025;</text> </paragraph> <paragraph num="(i)"> <text>A hazard analysis and food safety plan as required by Regulation .08B and C of this chapter; and</text> </paragraph> <paragraph num="(j)"> <text>Any other information that may be required by the Department to ascertain compliance of the plans and specifications with all applicable federal, State and local laws, regulations, and ordinances.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge may not construct a new food processing plant, remodel an existing food processing plant, or manufacture a food using a new or modified process before receiving written approval of the plans and specifications from the Department.</text> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review the plans and specifications to ensure compliance with the applicable regulations;</text> </paragraph> <paragraph num="(2)"> <text>Inform in writing the individual who submitted the plans and specifications:</text> <paragraph num="(a)"> <text>Of additional information that may be required; and</text> </paragraph> <paragraph num="(b)"> <text>Following the review, whether the plans and specifications are approved or denied; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the plans are denied, provide the individual in writing who submitted the plans and specifications with information on how to appeal the decision, as set forth in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The person-in-charge shall ensure that before a new or remodeled food processing plant is operated:</text> <paragraph num="(1)"> <text>The Department schedules and completes an inspection;</text> </paragraph> <paragraph num="(2)"> <text>The Department issues written approval for the use of the new or remodeled plant; and</text> </paragraph> <paragraph num="(3)"> <text>For a new plant, a food processing license is obtained.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review the plans and specifications to ensure compliance with the applicable regulations;</text> </paragraph> <paragraph num="(2)"> <text>Conduct a priority assessment of the facility based on the information obtained pursuant to §A(2)(d) and (e) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Classify a food processing plant as a:</text> <paragraph num="(a)"> <text>High priority facility, if the food processing plant manufactures food:</text> <paragraph num="(i)"> <text>Using specialized processes that require a scheduled process or a HACCP Plan;</text> </paragraph> <paragraph num="(ii)"> <text>Using ingredients that require temperature control for safety; or</text> </paragraph> <paragraph num="(iii)"> <text>That is temperature controlled for safety;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Moderate priority facility, if the food processing plant:</text> <paragraph num="(i)"> <text>Manufactures food using ingredients that do not require temperature control for safety;</text> </paragraph> <paragraph num="(ii)"> <text>Manufactures food that is not temperature controlled for safety; or</text> </paragraph> <paragraph num="(iii)"> <text>Is a food warehouse that stores and distributes food that requires temperature control for safety; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Low priority facility, if the food processing plant is a food warehouse that stores food or ingredients that do not require temperature control for safety.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Department may allow the use of equipment that meets the requirements of Regulation .10C—E of this chapter but fails to comply with Regulation .10A of this chapter if a review indicates the equipment and its use are:</text> <paragraph num="(1)"> <text>Not harmful to public health; and</text> </paragraph> <paragraph num="(2)"> <text>Consistent with industry standards and practices.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department may accept plant, facilities, and grounds design and construction other than those that are provided for in Regulation .09 of this chapter based on a review that shows the alternative plant, facilities, and grounds design:</text> <paragraph num="(1)"> <text>Provides for adequate food safety, food protection, and sanitation; and</text> </paragraph> <paragraph num="(2)"> <text>Is equivalent to regulatory and industry standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="On-Farm Home Processing."> <paragraph num="A."> <text>The Department may issue a food processing plant license to an individual who owns, leases, rents, or resides on a farm to process food in a home or domestic kitchen, located on the individual’s farm, as set forth in this regulation.</text> </paragraph> <paragraph num="B."> <text>While operating with a license issued in accordance with §A of this regulation, the person-in-charge shall:</text> <paragraph num="(1)"> <text>Comply with this chapter except for:</text> <paragraph num="(a)"> <text>Regulation .09C(2)(a), D, and E; and</text> </paragraph> <paragraph num="(b)"> <text>Regulation .12D, F(3), and G(1);</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Limit processed food production to:</text> <paragraph num="(a)"> <text>An amount of food that can safely be produced in the domestic kitchen as evidenced by:</text> <paragraph num="(i)"> <text>Sanitation;</text> </paragraph> <paragraph num="(ii)"> <text>Process; and</text> </paragraph> <paragraph num="(iii)"> <text>Cross-contamination control; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>$50,000 or less of sales other than foods processed under §§E and F of this regulation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Process commercially only during times when the kitchen is not being used for domestic purposes;</text> </paragraph> <paragraph num="(4)"> <text>Clean and sanitize all food-contact surfaces, equipment, and utensils, immediately before and after processing commercially;</text> </paragraph> <paragraph num="(5)"> <text>While processing commercially:</text> <paragraph num="(a)"> <text>Use only building areas, equipment, and utensils that the Department has reviewed or inspected and approved; and</text> </paragraph> <paragraph num="(b)"> <text>Remove all animals and individuals not involved in food processing from the kitchen; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Store ingredients for commercial manufacturing and finished manufactured food in a separate area from foods used domestically.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §§E and F of this regulation, an individual licensed in accordance with this regulation may manufacture and process only:</text> <paragraph num="(1)"> <text>Baked cakes, muffins, or cookies with a water activity of .85 or less;</text> </paragraph> <paragraph num="(2)"> <text>Fruit pies with an equilibrated pH of 4.6 or less;</text> </paragraph> <paragraph num="(3)"> <text>Canned acid foods with an equilibrated pH of 4.6 or less;</text> </paragraph> <paragraph num="(4)"> <text>Herbs in vinegar with an equilibrated pH of 4.6 or less;</text> </paragraph> <paragraph num="(5)"> <text>Honey and herb mixtures;</text> </paragraph> <paragraph num="(6)"> <text>Dried fruits and vegetables; and</text> </paragraph> <paragraph num="(7)"> <text>Acidified foods.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual licensed in accordance with this regulation may not process:</text> <paragraph num="(1)"> <text>Low-acid canned foods;</text> </paragraph> <paragraph num="(2)"> <text>Cured or fermented foods;</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in §E(6) of this regulation, seafood;</text> </paragraph> <paragraph num="(4)"> <text>Apple cider or other juices;</text> </paragraph> <paragraph num="(5)"> <text>Grade A milk product or manufactured grade milk product as defined in Health-General Article, §21-401, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(6)"> <text>A frozen dessert as defined in Health-General Article, §21-801(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual licensed in accordance with this regulation may:</text> <paragraph num="(1)"> <text>Weigh, label, and sell raw meat and poultry that is under the jurisdiction of the United States Department of Agriculture;</text> </paragraph> <paragraph num="(2)"> <text>Distribute raw meat or poultry that is under the jurisdiction of the United States Department of Agriculture;</text> </paragraph> <paragraph num="(3)"> <text>Weigh, package, label, and sell raw meat and poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Distribute raw meat or poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Process only animals that were:</text> <paragraph num="(a)"> <text>Commercially raised, fed, or managed on the farm; and</text> </paragraph> <paragraph num="(b)"> <text>Slaughtered and processed in accordance with Regulation .17 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>While operating a fish farm, clean, weigh, package, label, and sell, or distribute, raw finfish from the farm that are not associated with histamine intoxication; and</text> </paragraph> <paragraph num="(7)"> <text>Use shared equipment and utensils for both domestic and commercial uses provided that the equipment and utensils are:</text> <paragraph num="(a)"> <text>Designed and constructed as set forth in Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Cleaned and sanitized as set forth in Regulation .11 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>An individual licensed in accordance with this regulation may weigh, label, store, and distribute cheese that:</text> <paragraph num="(1)"> <text>Is made on a licensed out-of-State dairy facility using only the raw milk produced by the herd on the dairy farm licensed by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the definition and standards of a hard cheese, as set forth in section 21 CFR §133.150.</text> </paragraph> </paragraph> <paragraph num="G."> <text>When a farm ceases to be a farm, a food processing license issued in accordance with this regulation becomes void.</text> </paragraph> <paragraph num="H."> <text>In the absence of a license issued in accordance with COMAR 10.15.03, a license issued in accordance with this regulation shall provide for the sale on the farm of food processed on the farm by the licensee.</text> </paragraph> <paragraph num="I."> <text>Except as provided in Regulation .17 of this chapter, a person may not process food for human consumption on a farm without the license required in Regulation .18A of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Producer Mobile Farmer’s Market Unit."> <paragraph num="A."> <text>The Department may issue a food processing plant license to operate a producer mobile farmer’s market unit to transport for sale at a farmer’s market, public festival, or public event, TCS food products:</text> <paragraph num="(1)"> <text>Produced or stored on the farm by the licensee under an on-farm home processing plant license;</text> </paragraph> <paragraph num="(2)"> <text>Produced or stored on the farm by the licensee, as authorized by the Department in regulation; or</text> </paragraph> <paragraph num="(3)"> <text>That have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge shall ensure that the producer mobile farmer’s market unit:</text> <paragraph num="(1)"> <text>Complies with Regulations .07G, N, and O and .10D, H, and K of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Displays the license on the unit during operation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A local health department shall:</text> <paragraph num="(1)"> <text>Enforce §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Levy fines as established in local law, ordinance, or regulation;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Department of any violations occurring in the county; and</text> </paragraph> <paragraph num="(4)"> <text>Accept a valid producer mobile farmer’s market unit license to sell products authorized for sale under the license without requiring separate licenses or permits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Animal Slaughtering, Meat Processing, and Poultry Processing."> <text>A person that slaughters animals and processes meat shall ensure that:</text> <paragraph num="A."> <text>Animal slaughtering, meat processing, poultry processing, meat sales, and poultry sales are regulated and inspected in conformance with the applicable:</text> <paragraph num="(1)"> <text>Federal laws;</text> </paragraph> <paragraph num="(2)"> <text>Federal regulations;</text> </paragraph> <paragraph num="(3)"> <text>State laws;</text> </paragraph> <paragraph num="(4)"> <text>State regulations;</text> </paragraph> <paragraph num="(5)"> <text>Local laws; and</text> </paragraph> <paragraph num="(6)"> <text>Local regulations;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Cattle, sheep, swine, goats, horses, mules, and other equine are slaughtered and processed in accordance with:</text> <paragraph num="(1)"> <text>The Federal Meat Inspection Act, 21 U.S.C. §§601—695; and</text> </paragraph> <paragraph num="(2)"> <text>Applicable federal, State, and local laws and regulations;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Poultry are slaughtered and processed in accordance with:</text> <paragraph num="(1)"> <text>The Poultry Products Inspection Act, 21 U.S.C. §§451—471; and</text> </paragraph> <paragraph num="(2)"> <text>Applicable federal, State, and local regulations;</text> </paragraph> </paragraph> <paragraph num="D."> <text>When slaughtered and processed for food for the public, domesticated animals, including poultry and rabbits that are not required by federal law or regulation to be inspected by the United States Department of Agriculture, are:</text> <paragraph num="(1)"> <text>Inspected by the:</text> <paragraph num="(a)"> <text>United States Department of Agriculture under a voluntary inspection program; or</text> </paragraph> <paragraph num="(b)"> <text>Maryland Department of Agriculture under a voluntary inspection program; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Processed into human food while being regulated by:</text> <paragraph num="(a)"> <text>The United States Department of Agriculture under a voluntary inspection program; or</text> </paragraph> <paragraph num="(b)"> <text>A meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>When processing deer meat for charitable donation:</text> <paragraph num="(1)"> <text>Any processed deer is legally harvested;</text> </paragraph> <paragraph num="(2)"> <text>Gutting and skinning of the deer and butchering operations shall be separated by:</text> <paragraph num="(a)"> <text>Time; or</text> </paragraph> <paragraph num="(b)"> <text>Distance;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Processing other animal species is separated by:</text> <paragraph num="(a)"> <text>Time; or</text> </paragraph> <paragraph num="(b)"> <text>Distance;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Hanging meat carcasses are stored at an internal temperature of 41°F or less;</text> </paragraph> <paragraph num="(5)"> <text>Deer is processed for distribution only as fresh or frozen:</text> <paragraph num="(a)"> <text>Raw whole cuts; or</text> </paragraph> <paragraph num="(b)"> <text>Raw, ground 100 percent venison;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Organ meat is not donated; and</text> </paragraph> <paragraph num="(7)"> <text>A label containing cooking instructions is included.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Licensing."> <paragraph num="A."> <text>In order to operate a food processing plant, a person shall obtain a food processing license pursuant to the provisions of:</text> <paragraph num="(1)"> <text>Health-General Article, §§21-211 and 21-305, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>This chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall specify on the food processing license what foods or food types the licensee is authorized to process.</text> </paragraph> <paragraph num="C."> <text>The Department shall deny an application for a license if the applicant:</text> <paragraph num="(1)"> <text>Does not meet the requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A regulation promulgated under Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively attempts to obtain a license.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may suspend or revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Violates or fails to meet the requirements of §C of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively obtains a license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may deny an application for a food processing plant license and may suspend or revoke a license pursuant to the provisions of:</text> <paragraph num="(1)"> <text>Health-General Article, §§21-211, 21-311, and 21-314—21-317, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Food is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The required food processing license is conspicuously posted in the plant; and</text> </paragraph> <paragraph num="(3)"> <text>The processing operations in the plant are limited to the food type or types specified on the license pursuant to §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Except as provided in §H of this regulation, a license may not be transferred from one person to another person or from one food processing plant to another.</text> </paragraph> <paragraph num="H."> <text>On the death of a licensee, the approving authority may transfer a food processing plant license if:</text> <paragraph num="(1)"> <text>An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Written evidence establishes that the applicant’s relationship with the deceased was as a:</text> <paragraph num="(a)"> <text>Spouse of the deceased licensee;</text> </paragraph> <paragraph num="(b)"> <text>Blood relative to the first degree of consanguinity; or</text> </paragraph> <paragraph num="(c)"> <text>Current officer or surviving partner in the business operating the food processing plant.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Vacant." /> <regulation prefix="Regulation" num=".20" heading="Inspections."> <paragraph num="A."> <text>The person-in-charge shall permit a representative of the Department to:</text> <paragraph num="(1)"> <text>Enter a food processing plant at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Examine the records of the facility that pertain to information regarding food and supplies:</text> <paragraph num="(a)"> <text>Purchased;</text> </paragraph> <paragraph num="(b)"> <text>Received;</text> </paragraph> <paragraph num="(c)"> <text>Manufactured;</text> </paragraph> <paragraph num="(d)"> <text>Sold; or</text> </paragraph> <paragraph num="(e)"> <text>Distributed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The person-in-charge shall inform the Department of a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>The person-in-charge shall provide information to the Department regarding a food ingredient or recipe that the person-in-charge considers a trade secret if:</text> <paragraph num="(1)"> <text>An immediate and substantial danger to public health exists involving the food ingredient or recipe; or</text> </paragraph> <paragraph num="(2)"> <text>The Department determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Compliance with this chapter is continuous;</text> </paragraph> <paragraph num="(2)"> <text>Violations are corrected within the time for correction given by the Department;</text> </paragraph> <paragraph num="(3)"> <text>When a violation of a critical item exists:</text> <paragraph num="(a)"> <text>The violation is corrected immediately;</text> </paragraph> <paragraph num="(b)"> <text>Food processing affected by the critical item violation ceases; or</text> </paragraph> <paragraph num="(c)"> <text>The food processing plant is closed immediately; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For a food processing plant that operates seasonally or intermittently, inspection and regulation by the Department is facilitated by notifying the Department of:</text> <paragraph num="(a)"> <text>The dates and times of operation; or</text> </paragraph> <paragraph num="(b)"> <text>Information necessary to ensure that the Department has the opportunity to inspect the food processing plant during plant operation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall maintain the confidentiality of trade secret information in accordance with General Provisions Article, §4-335, and Health-General Article, §21-259, Annotated Code of Maryland.</text> </paragraph> <paragraph num="F."> <text>When an inspection of a food processing plant is made, the Department shall:</text> <paragraph num="(1)"> <text>Complete an inspection report that identifies the:</text> <paragraph num="(a)"> <text>Conditions found that violate the provisions of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Critical item violations, noted separately from all other violations;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide a copy of the inspection report to the person-in-charge of the plant; and</text> </paragraph> <paragraph num="(3)"> <text>Make the completed inspection report form available for public disclosure in accordance with General Provisions Article, §§4-101—4-104, 4-201—4-206, 4-301—4-362, and 4-501—4-503, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall ensure that a food processing plant is inspected:</text> <paragraph num="(1)"> <text>As determined by the Department or by statute for the enforcement of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>At a minimum of the frequency required by COMAR 10.15.07.01 for any shellfish:</text> <paragraph num="(a)"> <text>Shucker-packer; or</text> </paragraph> <paragraph num="(b)"> <text>Repacker;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At a minimum of two times per year for any shellfish:</text> <paragraph num="(a)"> <text>Shipper; or</text> </paragraph> <paragraph num="(b)"> <text>Reshipper;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At another frequency for shellfish required by COMAR 10.15.07.01; or</text> </paragraph> <paragraph num="(5)"> <text>When a:</text> <paragraph num="(a)"> <text>High priority plant, at a minimum of once per 12 months;</text> </paragraph> <paragraph num="(b)"> <text>Moderate priority plant, at a minimum of once per 24 months; and</text> </paragraph> <paragraph num="(c)"> <text>Low priority plant, at a minimum of once every 36 months.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Enforcement."> <paragraph num="A."> <text>The approving authority shall ensure that when a food processing plant is found in violation of any provision of this chapter, the licensee is notified:</text> <paragraph num="(1)"> <text>Of the specific:</text> <paragraph num="(a)"> <text>Findings; and</text> </paragraph> <paragraph num="(b)"> <text>Date by which the licensee shall correct the violations or deficiencies; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-261 or 21-318, Annotated Code of Maryland, directing the person to abate the violation within a specified time period.</text> </paragraph> <paragraph num="C."> <text>The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>In order to preserve a right to a hearing under any provision of this regulation, a person shall:</text> <paragraph num="(1)"> <text>Make a request for a hearing in writing; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the request to the approving authority that issued the order or inspection report:</text> <paragraph num="(a)"> <text>Within 10 days of receipt of the order;</text> </paragraph> <paragraph num="(b)"> <text>Sooner if specified in the order; or</text> </paragraph> <paragraph num="(c)"> <text>Within 24 hours if the violation requires immediate correction or correction within 24 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The approving authority shall suspend or revoke the license of a food processing plant if the licensee fails or neglects to:</text> <paragraph num="(1)"> <text>Correct a:</text> <paragraph num="(a)"> <text>Violation within the specified time period; or</text> </paragraph> <paragraph num="(b)"> <text>Violation of a critical item immediately; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comply with an approved written schedule of compliance.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The approving authority shall ensure that:</text> <paragraph num="(1)"> <text>An action to suspend or revoke a license, complies with the provisions of:</text> <paragraph num="(a)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Health-General Article, §21-315, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10- 226(c)(2), Annotated Code of Maryland, the:</text> <paragraph num="(1)"> <text>Approving authority shall:</text> <paragraph num="(a)"> <text>Summarily suspend the license at the food processing plant;</text> </paragraph> <paragraph num="(b)"> <text>Order the food processing plant to cease operation immediately; and</text> </paragraph> <paragraph num="(c)"> <text>Promptly provide the licensee with:</text> <paragraph num="(i)"> <text>A written notice of suspension of the license;</text> </paragraph> <paragraph num="(ii)"> <text>The reasons for the suspension; and</text> </paragraph> <paragraph num="(iii)"> <text>Instructions on requesting an administrative hearing if desired; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Person-in-charge shall immediately cease the operation of the food processing plant.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The person-in-charge shall ensure that a food processing plant that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exist.</text> </paragraph> <paragraph num="I."> <text>The approving authority shall confirm that appropriate steps are taken to ensure that the licensee ceases operation of the food processing plant on suspension or revocation of the license, including:</text> <paragraph num="(1)"> <text>Taking and keeping physical possession of the license until the license is reinstated; and</text> </paragraph> <paragraph num="(2)"> <text>Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A person whose food processing plant license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Foodborne Disease Investigation and Control."> <text>The approving authority shall ensure that:</text> <paragraph num="A."> <text>When there is reasonable cause to suspect foodborne disease transmission or an outbreak from a food processed or distributed by a food processing plant, an inspection of the plant is conducted to:</text> <paragraph num="(1)"> <text>Identify:</text> <paragraph num="(a)"> <text>Potential points of food contamination in the facility;</text> </paragraph> <paragraph num="(b)"> <text>Whether employee illness may have contributed; and</text> </paragraph> <paragraph num="(c)"> <text>Whether a contaminated ingredient was used to process a food; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Determine if affected food has been distributed into commerce; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>The appropriate follow-up action is taken, which may include immediate:</text> <paragraph num="(1)"> <text>Closing of the food processing plant, or a portion of the plant that is used to process the implicated product; or</text> </paragraph> <paragraph num="(2)"> <text>Exclusion of a suspect employee from all food handling positions within the plant until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low in accordance with COMAR 10.06.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Traceability, Sampling, and Detention."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Records are maintained that allow for traceability of food or food ingredients received by the food processing plant that include the:</text> <paragraph num="(a)"> <text>Date received; and</text> </paragraph> <paragraph num="(b)"> <text>Previous source’s:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address; and</text> </paragraph> <paragraph num="(iii)"> <text>Contact information;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Records are maintained that allow for traceability of food and food ingredients that identify the initial distribution of the food that include:</text> <paragraph num="(a)"> <text>The date the food was released;</text> </paragraph> <paragraph num="(b)"> <text>A lot code number or other identifier, if available;</text> </paragraph> <paragraph num="(c)"> <text>The type of food released, including brand name and specific variety; and</text> </paragraph> <paragraph num="(d)"> <text>For the transporter of the food and the intended immediate recipient, the:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address; and</text> </paragraph> <paragraph num="(iii)"> <text>Contact information;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>All records maintained that allow for traceability are made available to the Department for review and copying upon request; and</text> </paragraph> <paragraph num="(4)"> <text>The collection of food and environmental samples by the Department is allowed in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Collect food and environmental samples as often as necessary for enforcement of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Take action on a food where indicated in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by:</text> <paragraph num="(a)"> <text>Issuing a detention order;</text> </paragraph> <paragraph num="(b)"> <text>Seeking voluntary destruction; or</text> </paragraph> <paragraph num="(c)"> <text>Filing a petition for an order of forfeiture for destruction.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-234,21-301, 21-304, 21-308, 21-309.1, 21-309.2, and 21-336; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 18, 1960</annotation> <annotation type="History" subtype="Administrative History">Amended effective January 1, 1964; June 8, 1965; July 1, 1966; April 1, 1967; December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulation .29 adopted effective September 21, 1979 (6:19 Md. R. 1519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29 amended effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2711)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 28, 1992 (19:19 Md. R. 1708); April 3, 2000 (27:6 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 amended effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33A amended effective March 4, 1991 (18:4 Md. R. 447); September 28, 1992 (19:19 Md. R. 1708); October 6, 1997 (24:20 Md. R. 1404)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .37 repealed and new Regulations .01 — .20 adopted effective November 22, 2004 (31:23 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19C, D amended effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19G adopted effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 adopted effective May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); revised permanently effective January 24, 2011 (38:2 Md. R. 83)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163); February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A, D amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17D, E adopted effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17E amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C, D amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E adopted effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E adopted effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 repealed effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23G amended effective January 6, 2014 (40:26 Md. R. 2163)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28C amended effective February 15, 2016 (43:3 Md. R. 272)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation 15A, B, F amended effective January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A, C amended effective January 5, 2026 (52:26 Md. R. 1309)</annotation> </annotations> </chapter> <chapter num="05" heading="Manufacture and Sale of Frozen Dairy Foods and Ices Manufactured for Sale in Maryland"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Item 10p., Item 11p., Appendix H, Appendix I, and Appendix N only, is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Ice Cream and Frozen Custard."> <text>Ice cream and frozen custard are the foods prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Ice Milk."> <paragraph num="A."> <text>Ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk.</text> </paragraph> <paragraph num="B."> <text>Ice milk shall be offered for sale, sold, or served only in properly labeled factory-filled containers, if the ice milk or any of its ingredients contain added color or any ingredients added for the purpose of imparting a characterizing flavor, except that ice milk may be served and sold at retail from a dispensing freezer.</text> </paragraph> <paragraph num="C."> <text>When ice milk is sold at retail, direct from a frozen dessert dispensing freezer, a sign shall be prominently and conspicuously displayed, where it can be clearly read by customers under normal conditions of purchase, stating “Ice Milk Sold Here”. The letters on the sign shall be bold-face capitals at least 3 inches high and in contrasting color to the background. When ice milk is sold at retail, only in properly labeled factory-filled containers, this sign is not required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Mellorine."> <paragraph num="A."> <text>Mellorine is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.130, Mellorine.</text> </paragraph> <paragraph num="B."> <text>Mellorine shall be sold, held, offered for sale only in factory-filled containers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sherbet."> <text>Sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140, Sherbet.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Water Ices."> <text>Water ices are the foods each of which is prepared from the ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21, Food and Drugs, Part 135.160, Water Ices.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Goat Milk Ice Cream."> <paragraph num="A."> <text>Description. Goat milk ice cream is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard, except that all milkfat and nonfat milk solids shall be derived from goat milk.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “goat milk ice cream”.</text> </paragraph> <paragraph num="C."> <text>Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words “ice cream”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Goat Milk Ice Milk."> <paragraph num="A."> <text>Description. Goat milk ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk, except that all milkfat and nonfat milk solids shall be derived from goat milk.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “goat milk ice milk”.</text> </paragraph> <paragraph num="C."> <text>Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words, “ice milk”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Frozen Yogurt."> <paragraph num="A."> <text>Description. Frozen yogurt is the food prepared by freezing while stirring a pasteurized mix consisting of the same ingredients permitted for ice cream in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110. These ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgarius and streptococcus thermophilus, provided, however, fruits, nuts or other flavoring materials may be added before or after the mix is pasteurized and cultured. Bacteria and coliform requirements for frozen yogurt shall apply to the mix before culturing. Coliform requirements for frozen yogurt shall apply to the mix after culturing. Frozen yogurt, exclusive of any flavoring, shall contain not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than the result of bacterial activity, shall be applied to the product after culturing. No heat or bacteriostatic treatment (other than refrigeration), which results in the total destruction of the microorganisms, may be applied to the product after culturing. The finished yogurt shall weigh not less than 5 pounds per gallon.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “frozen yogurt”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Lowfat Frozen Yogurt."> <paragraph num="A."> <text>Description. Lowfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Lowfat frozen yogurt, exclusive of any flavorings, shall contain not less than .5 percent or more than 2.0 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than .5 percent expressed as lactic acid.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “lowfat frozen yogurt”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Nonfat Frozen Yogurt."> <paragraph num="A."> <text>Description. Nonfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Nonfat frozen yogurt, exclusive of any flavorings, shall contain less than .5 percent milkfat.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “nonfat frozen yogurt”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Quiescently Frozen Confection."> <paragraph num="A."> <text>Description. Quiescently frozen confection means the frozen product made from sweetening agents, harmless natural or artificial flavoring, and water, and it may contain milk solids, harmless coloring, organic acids, and any safe and suitable functional ingredient approved by the Secretary. The finished product shall contain not less than 17 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “quiescently frozen confection”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Quiescently Frozen Dairy Confection."> <paragraph num="A."> <text>Description. Quiescently frozen dairy confection means the frozen product made from milk products, sweetening agents, harmless natural or artificial flavoring, and water, and it may contain harmless coloring, and any safe and suitable functional ingredient approved by the Secretary. The finished product contains not less than 33 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen dairy confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “quiescently frozen dairy confection”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Frozen Dietary Dairy Dessert."> <paragraph num="A."> <text>Description. Frozen dietary dairy dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The minimum fat content shall be 3 percent, it shall contain no sugars other than those naturally present in the milk solids or flavoring agents which have been added to it, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department. The product may not be sold in any manner other than in sealed or unbroken packages or containers.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “frozen dietary dairy dessert”.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>Immediately preceding or following the name of the product, there shall be a statement as follows: “Contains ___% milkfat”. The blank is to be filled in with the percentage of milkfat in the product. The label of frozen dietary dairy dessert shall contain the statement: “Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food.”</text> </paragraph> <paragraph num="(2)"> <text>In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Dietary Frozen Dessert or Lowfat Frozen Dairy Desserts."> <paragraph num="A."> <text>Description.</text> <paragraph num="(1)"> <text>Dietary frozen dessert or lowfat frozen dairy dessert is the food prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The finished product contains less than 2 percent by weight of ether extractable fat: its content of total milk solids is not less than 7 percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds or more than 1.9 pounds, exclusive of any microcrystalline cellulose used as an ingredient.</text> </paragraph> <paragraph num="(2)"> <text>One or more vitamins or minerals, or both, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.9 may be added to the product. If vitamins or minerals, or both, are added, each 4-fluid-ounce serving of finished product shall provide not less than 8 percent or more than 20 percent of the U. S. Recommended Daily Allowance of these vitamins or minerals, or both.</text> </paragraph> <paragraph num="(3)"> <text>Dietary frozen dessert or lowfat frozen dairy dessert may be sold in properly labeled factory-filled containers, except it may be sold directly from a dispensing freezer at the time of a direct request from a customer. When sold directly from a dispensing freezer, each container shall be labeled with the name of the product and with the name of the product and with nutritional and ingredient information as prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “dietary frozen dessert” or “lowfat frozen dairy dessert”.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>If vitamins or minerals, or both, are added, the name of the food on the principal display panel and each alternate principal display panel shall be immediately preceded or followed by the word “fortified” in the same style and at least one-half the size of the type used for the name “dietary frozen dessert” or “lowfat frozen dairy dessert” and on the same contrasting background.</text> </paragraph> <paragraph num="(2)"> <text>In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Non-fruit Sherbet."> <paragraph num="A."> <text>Description. Non-fruit sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140 Sherbet, except that the food may not contain any fruit or fruit juice.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “Non-fruit ___ Sherbet”. The blank is to be filled in by the characterizing flavor used.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>The label shall contain the following statement: “Imitation ___ Sherbet”, the blank to be filled in by the characterizing flavor used. The letters in the word “imitation” shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, sherbet.</text> </paragraph> <paragraph num="(2)"> <text>The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice” in letters at least half the size of the words used in the statement.</text> </paragraph> <paragraph num="(3)"> <text>When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Non-fruit Water Ice."> <paragraph num="A."> <text>Description. Non-fruit water ice is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.160 Water Ices, except that the food may not contain any fruit or fruit juice. The finished non-fruit water ice weighs not less than 6 pounds per gallon.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “Non-fruit ___ Water Ice”. The blank is to be filled in by the characterizing flavor used.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>The label shall contain the following statement: “Imitation ___ Ice”. The blank is to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, ice.</text> </paragraph> <paragraph num="(2)"> <text>The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice”, in letters at least half the size of the words used in the statement.</text> </paragraph> <paragraph num="(3)"> <text>When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Manufactured Desserts Mix."> <paragraph num="A."> <text>Description. “Manufactured desserts mix”, whipped cream confection, bisque tortoni, means a frozen dessert made with milk products, sweetening agents, flavoring agents, with or without harmless coloring or any other safe and suitable ingredients approved by the Secretary. It contains not less than 18 percent by weight of milkfat, and not more than 12 percent of milk solids not fat, and may be packaged with harmless gas causing it to fluff upon ejection from the package or container.</text> </paragraph> <paragraph num="B."> <text>Labeling. In addition to all other required information, the label shall comply with the provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Freezer-Made Shake Freezer-Made Milk Shake."> <paragraph num="A."> <text>“Freezer-made milk shake” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mix consisting of the ingredients prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120 Ice Milk, except that:</text> <paragraph num="(1)"> <text>It shall contain not less than 3-1/4 percent and not more than 6 percent milkfat.</text> </paragraph> <paragraph num="(2)"> <text>Its contents of milk solids not fat shall be not less than 10 percent. Freezer-made milk shake may only be sold or served from a dispensing freezer and may not be sold hard-frozen.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Other freezer-made shakes including jumbo shake, thick shake, T.V. shake, or any coined or trade name containing the word, “shake”, shall meet the requirements of §A, of this regulation, except that the minimum percent of milk fat may be less than 3-1/4 percent.</text> </paragraph> <paragraph num="C."> <text>“Shakes” not meeting the requirements for “milk shakes” may not be advertised, sold, or served as milk shakes.</text> </paragraph> <paragraph num="D."> <text>When any freezer-made milk shake or other freezer-made shake purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Parevine."> <paragraph num="A."> <text>Description.</text> <paragraph num="(1)"> <text>Parevine is the food which is prepared by freezing while stirring, a pasteurized mix composed of one or more edible vegetable oils or fats, protein and carbohydrate food ingredients from other than milk or meat sources, nutritive sweeteners other than lactose, characterizing ingredients except any containing meat or milk, and any other safe and suitable ingredient which is not milk or meat or a product or derivative of milk or meat. This product may not contain any milk, milk product, meat, or meat products or any of their derivatives of any kind.</text> </paragraph> <paragraph num="(2)"> <text>Its fat content shall be not less than 10 percent, except that when bulky optional characterizing ingredients are used, the fat content may be reduced, as a result of the addition of these ingredients, but may not be less than 8 percent.</text> </paragraph> <paragraph num="(3)"> <text>Its content of food solids shall be not less than 1.3 pounds per gallon of finished product.</text> </paragraph> <paragraph num="(4)"> <text>Parevine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in factory-filled containers. Parevine may be served for consumption on the premises provided that the individual service is taken from a properly labeled factory-filled container. When parevine is served for consumption on the premises, a sign shall be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating “PAREVINE SOLD HERE”. Letters on the sign shall be bold face capitals at least 3 inches high and in contrasting color to the background. The sign need not be displayed if each customer is provided with a menu which there is stated “PAREVINE SERVED HERE” in bold face capitals as large as those in listing most food items.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “parevine”.</text> </paragraph> <paragraph num="C."> <text>Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19-1" heading="Lowfat Parevine."> <paragraph num="A."> <text>Description. “Lowfat parevine” means food which meets all of the requirements of Regulation .19, of this chapter, relating to parevine except its fat content shall be not more than 6.0 percent. The sign required by Regulation .19A(4), of this chapter, shall read “LOWFAT PAREVINE SOLD HERE”.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “lowfat parevine”.</text> </paragraph> <paragraph num="C."> <text>Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutrition information as required by Title 21, Part 101.9.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Lo-Mel."> <paragraph num="A."> <text>Description.</text> <paragraph num="(1)"> <text>“Lo-mel” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mixture of edible fats or oils other than milkfat, milk solids not fat, water, optional sweetening ingredients as approved by the Secretary, with or without egg or egg products, with or without harmless flavoring, with or without harmless coloring, and with or without stabilizer or emulsifier as approved by the Secretary. It shall contain not more than 6 percent edible fats or oils. It shall contain not less than 10 percent milk solids not fat. It may contain any other safe and suitable ingredients approved by the Secretary. It shall contain not more than 1/2 percent by weight of stabilizer and not more than one-fifth of one percent of emulsifier.</text> </paragraph> <paragraph num="(2)"> <text>Lo-mel may only be served or sold directly from a dispensing freezer and may not be sold hard frozen.</text> </paragraph> <paragraph num="(3)"> <text>When Lo-mel is sold from a dispensing freezer a sign shall be displayed which shall read “Lo-mel Served Here”, in letters at least 3 inches high and shall include a list of all ingredients in a manner prescribed by the Secretary, provided, however, that the name of the edible fats or oils other than milk fat used must be specified. The letters of the sign are to be of sufficient size to be read by consumers under normal conditions of purchase. The list of ingredients need not be included on the sign if the list of ingredients is printed on the side of the container in which the product is served to the customer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “lo-mel”.</text> </paragraph> <paragraph num="C."> <text>Labeling. When any lo-mel purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20-1" heading="Lactose Reduced Ice Cream."> <paragraph num="A."> <text>Description. “Lactose reduced ice cream” means the product resulting from the treatment of ice cream, as defined in Regulation .01-1 of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice cream.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “lactose reduced ice cream”.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>The package label shall include in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required Part 101.4 and contain nutritional information as required by Title 21, Part 101.9.</text> </paragraph> <paragraph num="(2)"> <text>Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style, and size and in the same color and contrasting background as the words “Ice Cream”.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20-2" heading="Lactose Reduced Ice Milk."> <paragraph num="A."> <text>Description. “Lactose reduced ice milk” means the product resulting from the treatment of ice milk, as defined in Regulation .02, of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice milk.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “lactose reduced ice milk”.</text> </paragraph> <paragraph num="C."> <text>Labeling.</text> <paragraph num="(1)"> <text>The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required by Title 21, Part 101.9.</text> </paragraph> <paragraph num="(2)"> <text>Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style and size and in the same color and contrasting background as the words “Ice Milk”.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20-3" heading="Frozen Pudding."> <paragraph num="A."> <text>Description. “Frozen pudding” means the product made from a pasteurized mix, intended to be eaten in the frozen state. The mix may be composed of milk and milk products, modified or unmodified food starch, sweetening agents, harmless natural or artificial flavoring, or both, harmless natural or artificial color, or both, or any other safe or suitable functional ingredient. The finished product shall contain less than 25 percent total food solids. The weight of the finished product shall not be less than 4.5 pounds per gallon. If not frozen promptly after pasteurization, the finished product shall be cooled to 45°F or lower and maintained under conditions to assure suitability for consumption.</text> </paragraph> <paragraph num="B."> <text>Nomenclature. The name of the food is “frozen pudding”.</text> </paragraph> <paragraph num="C."> <text>Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Definitions."> <paragraph num="A."> <text>In Regulations .21 — .34 of this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adulterated”. Frozen desserts or frozen desserts mix shall be deemed to be adulterated if:</text> <paragraph num="(a)"> <text>It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health;</text> </paragraph> <paragraph num="(b)"> <text>It bears or contains any added poisonous or deleterious substances for which a safe tolerance has not been established by State or federal regulations, or in excess of the tolerance if one has been established;</text> </paragraph> <paragraph num="(c)"> <text>It consists, in whole or in part, of any substance unfit for human consumption;</text> </paragraph> <paragraph num="(d)"> <text>It has been produced, processed, prepared, packed, dispensed, or held under insanitary conditions;</text> </paragraph> <paragraph num="(e)"> <text>Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or</text> </paragraph> <paragraph num="(f)"> <text>Any substance has been added, mixed, or packed within the mix to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“CFR” means the Code of Federal Regulations of the United States Government.</text> </paragraph> <paragraph num="(3)"> <text>“C-I-P” means a procedure by which equipment, pipelines and other facilities are cleaned-in-place in accordance with 3-A Accepted Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems.</text> </paragraph> <paragraph num="(4)"> <text>“Dispensing freezer” means that type of equipment that freezes reconstituted powdered frozen dessert ingredients or frozen desserts mix into a semi-soft condition for serving to a customer.</text> </paragraph> <paragraph num="(5)"> <text>“Food service facility” means restaurants, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, sofa fountains, retail markets, and food operations in industries, institutions, hospitals, clubs, schools, camps, churches, catering kitchens, commissaries, or similar places in which food or drink is prepared for sale or for service on the premises or elsewhere, or any other operation where food is served or provided for the public with or without charge.</text> </paragraph> <paragraph num="(6)"> <text>“Frozen desserts” means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations .01-1 — .20-3 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>“Frozen desserts distributor” means any person who offers for sale or sells prepackaged frozen desserts.</text> </paragraph> <paragraph num="(8)"> <text>“Frozen desserts mix” or “mix” means any frozen dessert in a liquid form, prepared by a frozen desserts plant and intended for freezing before consumption.</text> </paragraph> <paragraph num="(9)"> <text>“Frozen desserts plant” means any place or premise where frozen desserts or frozen dessert mixes are manufactured, pasteurized, frozen, and packaged.</text> </paragraph> <paragraph num="(10)"> <text>“Milk products” include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation .01-1 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Misbranded”. Frozen desserts and frozen desserts mix are misbranded when:</text> <paragraph num="(a)"> <text>Their containers bear or accompany any false or misleading written, printed, or graphic matter;</text> </paragraph> <paragraph num="(b)"> <text>Frozen desserts do not conform to their definitions as contained in these regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Products are not labeled in accordance with Regulation .24 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“National Sanitation Foundation” means the National Sanitation Foundation, NSF Building, P.O. Box 1468, Ann Arbor, Michigan 48106.</text> </paragraph> <paragraph num="(13)"> <text>“Pasteurization”.</text> <paragraph num="(a)"> <text>The terms “pasteurization”, “pasteurized”, and similar terms mean the process of heating, in approved and properly operated equipment, every particle of mix containing milk and milk products to one of the following minimum temperatures and holding at this temperature continuously for the specified time as indicated below:</text> <paragraph num="(i)"> <text>155°F and holding at that temperature for at least 30 minutes;</text> </paragraph> <paragraph num="(ii)"> <text>175°F and holding at that temperature for at least 25 seconds;</text> </paragraph> <paragraph num="(iii)"> <text>180°F and holding at that temperature for at least 15 seconds;</text> </paragraph> <paragraph num="(iv)"> <text>194°F and holding at that temperature for at least 0.5 second.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Nothing contained in this section shall be construed as barring any other method or process, as may be demonstrated to be equally efficient and which is approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Person” means any individual, partnership, firm, corporation, or association.</text> </paragraph> <paragraph num="(15)"> <text>“Powdered frozen dessert ingredients” means any dry mixture of pasteurized dry milk products, including whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional casseinates, which is intended for reconstitution, freezing, and retail sale by a food service facility.</text> </paragraph> <paragraph num="(16)"> <text>“Retail frozen desserts manufacturer” means a person who manufactures frozen desserts from commercially supplied pasteurized mix derived from raw milk supplies having acceptable United States Public Health Service (U.S.P.H.S.) ratings, for retail sale directly to the consumer on the premises where manufactured.</text> </paragraph> <paragraph num="(17)"> <text>“Sanitization” means the application of any effective method or substance to a clean surface for the destruction of pathogens, and of other organisms as far as is practicable. This treatment may not adversely affect the equipment, frozen desserts, or the health of consumers, and shall be acceptable to the Secretary.</text> </paragraph> <paragraph num="(18)"> <text>“Secretary” means the Secretary of Health or his designee.</text> </paragraph> <paragraph num="(19)"> <text>"3-A Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee, as published by the Journal of Food Protection, P.O. Box 701, Ames, Iowa 50010.</text> </paragraph> <paragraph num="(20)"> <text>“Wholesale frozen desserts manufacturer” means a person who manufactures, pasteurizes, packages, or freezes any frozen desserts mix for distribution or sale other than for retail sale directly to the consumer on the premises where manufactured.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Quality of Milk Products Used in Frozen Desserts."> <text>All milk products used in frozen desserts shall be derived from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Adulterated or Misbranded Milk Products, Frozen Desserts or Frozen Desserts Mix."> <paragraph num="A."> <text>A person may not manufacture, freeze, sell, offer or expose for sale, or have in his possession with the intent to sell any milk product, frozen dessert ingredients, frozen dessert mix which is adulterated or misbranded or which does not conform to the product definition or of any regulation made and promulgated under these regulations.</text> </paragraph> <paragraph num="B."> <text>Any adulterated or misbranded milk product, frozen dessert ingredients, frozen dessert, or frozen dessert mix may be detained by the Secretary and disposed of in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Labeling."> <paragraph num="A."> <text>All labeling shall comply with the regulations promulgated under the Fair Packaging and Labeling Act and the Federal Food, Drug and Cosmetic Act, as contained in the Code of Federal Regulations, Title 21 Food and Drugs, and in addition shall contain:</text> <paragraph num="(1)"> <text>The name of the product, and shall conform with product standards of identity as provided in Regulations .01-1 — .20 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A statement of net contents or net volume.</text> </paragraph> <paragraph num="(3)"> <text>One of the following:</text> <paragraph num="(a)"> <text>The name of the manufacturer and the address of his plant;</text> </paragraph> <paragraph num="(b)"> <text>The Federal Information Processing System (FIPS) Number assigned by State agency followed by the general office address; or</text> </paragraph> <paragraph num="(c)"> <text>In case of private labels, the Federal Information Processing System (FIPS) Number and the name and address of the distributor, preceded or followed by “Distributed by” or “Distributor”.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The “date of pasteurization” in case of frozen dessert mixes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When frozen desserts are dispensed from factory-filled containers, each container shall bear an identity as described above so that it can be read after the lid or cover has been removed and discarded.</text> </paragraph> <paragraph num="C."> <text>Required labeling information shall be in letters of an acceptable size, kind, and color satisfactory to the Secretary and may not bear or accompany any false or misleading written, printed, or graphic matter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Quality Standards and Examination of Frozen Desserts Ingredients, Frozen Desserts, and Frozen Desserts Mix."> <paragraph num="A."> <text>All milk and milk products used as ingredients in frozen desserts and frozen desserts mix shall be produced, processed, and pasteurized to conform with the following chemical, bacteriological, and temperature standards:</text> </paragraph> <paragraph num="B."> <text>A process or manipulation, other than pasteurization processing methods, and appropriate refrigeration, may not be applied to milk and milk products for the purpose of removing or deactivating microorganisms.</text> </paragraph> <paragraph num="C."> <text>Bacterial counts, coliform determinations, cooling temperatures, phosphatase test and other laboratory and screening tests shall conform to the procedures in the latest edition of Standard Methods for the Examination of Dairy Products of the American Public Health Association and the latest edition of the Official Method of Analysis of the Association of Official Analytical Chemists.</text> </paragraph> <paragraph num="D."> <text>Examinations and tests shall include any other chemical, bacteriological, or physical determinations as the Secretary deems necessary for the detection of adulteration.</text> </paragraph> <paragraph num="E."> <text>Sterile frozen desserts mix in hermetically sealed containers shall meet all applicable requirements. Bacterial, coliform, and cooling standards do not apply to mix in hermetically sealed containers.</text> </paragraph> <paragraph num="F."> <text>When samples are obtained from bulk containers of frozen desserts or frozen desserts mix, only a cleaned and sanitized dipper shall be used to obtain a sample from a portion of the bulk amount not previously contacted by a dipper.</text> </paragraph> <paragraph num="G."> <text>Frozen dessert mix samples for determining the wholesale frozen dessert manufacturer’s compliance with bacteriological and temperature standards shall be collected while in the possession of the wholesale frozen dessert manufacturer before final delivery.</text> </paragraph> <paragraph num="H."> <text>Frozen dessert mix samples for chemical and physical analysis may be taken at any time.</text> </paragraph> <paragraph num="I."> <text>The wholesale frozen desserts manufacturer shall be held responsible only for those samples taken from unopened containers.</text> </paragraph> <paragraph num="J."> <text>Samples of hard frozen desserts, in unopened factory-filled containers, may be collected any time before sale for determining the wholesale frozen dessert manufacturer's or retail frozen dessert manufacturer's compliance with chemical and physical standards.</text> </paragraph> <paragraph num="K."> <text>Mix once drawn from a dispensing freezer shall not be re-used.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Frozen Desserts Plants — Construction Requirements."> <paragraph num="A."> <text>Floors — Construction.</text> <paragraph num="(1)"> <text>The floors of all rooms shall be kept in good repair subject to the following provisions:</text> <paragraph num="(a)"> <text>Rooms used for storing milk products or frozen desserts ingredients need not be provided with floor drains when the floors are sloped to drain to one or more exits;</text> </paragraph> <paragraph num="(b)"> <text>Rooms used for the hardening and storage of frozen desserts are not required to have floor drains or sloped floors;</text> </paragraph> <paragraph num="(c)"> <text>Storage rooms for storing dry ingredients, dry milk products, or packaging materials need not be provided with drains, and the floors may be constructed of tightly joined wood; and</text> </paragraph> <paragraph num="(d)"> <text>Construction of establishments which freeze and sell only at retail on the premises, shall require that the portion of the room in which the freezer is installed and the room in which containers or utensils are washed have solid impervious floors of an approved washable material;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The floors of all rooms except as provided in §A(1)(a) — (c) of this regulation shall be:</text> <paragraph num="(a)"> <text>Constructed of concrete or other equally impervious and easily cleaned material;</text> </paragraph> <paragraph num="(b)"> <text>Smooth;</text> </paragraph> <paragraph num="(c)"> <text>Properly sloped; and</text> </paragraph> <paragraph num="(d)"> <text>Provided with trapped drains.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Walls and Ceilings — Construction. Walls and ceilings of rooms in which milk products, frozen desserts ingredients, and frozen desserts are handled, processed, packaged, or stored, or in which product-contact containers, utensils, and equipment are washed, shall have a surface that is:</text> <paragraph num="(1)"> <text>Smooth;</text> </paragraph> <paragraph num="(2)"> <text>Washable;</text> </paragraph> <paragraph num="(3)"> <text>Light colored; and</text> </paragraph> <paragraph num="(4)"> <text>In good repair.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Doors and Windows.</text> <paragraph num="(1)"> <text>Effective means shall be provided to prevent the access of flies and rodents.</text> </paragraph> <paragraph num="(2)"> <text>Air screens and flaps may be used where they effectively prevent the entrance of insects.</text> </paragraph> <paragraph num="(3)"> <text>Openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather.</text> </paragraph> <paragraph num="(4)"> <text>Outside doors shall be self-closing where practicable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Lighting and Ventilation. Rooms in which milk products, frozen desserts ingredients, or frozen desserts are handled, processed, stored, and packaged, or in which product-contact containers, utensils, and equipment are washed shall be well lit and well ventilated.</text> </paragraph> <paragraph num="E."> <text>Separate Rooms.</text> <paragraph num="(1)"> <text>There shall be separate rooms for the following:</text> <paragraph num="(a)"> <text>Pasteurizing, processing, cooling, freezing, and packaging;</text> </paragraph> <paragraph num="(b)"> <text>Freezer-storage;</text> </paragraph> <paragraph num="(c)"> <text>Cleaning of milk cans and containers; and</text> </paragraph> <paragraph num="(d)"> <text>Boiler rooms.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Receiving Rooms.</text> <paragraph num="(a)"> <text>A plant receiving milk products or mix in bulk transport tanks shall provide a receiving room for receiving, cleaning, and sanitizing transport tanks.</text> </paragraph> <paragraph num="(b)"> <text>Unless all milk products and mix are received in bulk transport tanks, a receiving room separate from the rooms listed in §E(1) of this regulation, is required.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Rooms in which milk products, frozen dessert ingredients, or frozen desserts are handled, processed, stored, or packaged, or in which product-contact containers, utensils, and equipment are washed or stored, may not open directly into any room for domestic purposes.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Sanitary Piping.</text> <paragraph num="(1)"> <text>Sanitary piping, fittings, and connections which are exposed to milk products, frozen dessert ingredients, and frozen desserts mix, or from which liquids may drip, drain, or be drawn into the product, shall be constructed of material that is:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Impervious;</text> </paragraph> <paragraph num="(c)"> <text>Corrosion-resistant;</text> </paragraph> <paragraph num="(d)"> <text>Nontoxic; and</text> </paragraph> <paragraph num="(e)"> <text>Easily cleanable.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Piping shall be kept in good repair.</text> </paragraph> <paragraph num="(3)"> <text>Pasteurized milk products, frozen dessert ingredients, and frozen desserts mix shall be conducted from one piece of equipment to another only through sanitary piping as described in Items 10p. and 11p. in the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-1" heading="Frozen Desserts Plants — Water and Sanitation Requirements."> <paragraph num="A."> <text>Toilet-Sewage Disposal Facilities.</text> <paragraph num="(1)"> <text>A frozen desserts plant shall provide toilet facilities.</text> </paragraph> <paragraph num="(2)"> <text>Toilet rooms may not open directly into any room in which milk products, frozen dessert ingredients, or frozen desserts are processed or packaged.</text> </paragraph> <paragraph num="(3)"> <text>Toilet rooms shall:</text> <paragraph num="(a)"> <text>Be completely enclosed; and</text> </paragraph> <paragraph num="(b)"> <text>Have tight-fitting, self-closing doors.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lit.</text> </paragraph> <paragraph num="(5)"> <text>Sewage and other liquid wastes shall be disposed of as approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Water Supply.</text> <paragraph num="(1)"> <text>Water for frozen desserts plant purposes shall be:</text> <paragraph num="(a)"> <text>Obtained from a properly located, protected, and operated supply;</text> </paragraph> <paragraph num="(b)"> <text>Easily accessible;</text> </paragraph> <paragraph num="(c)"> <text>Adequate;</text> </paragraph> <paragraph num="(d)"> <text>Of a safe sanitary quality; and</text> </paragraph> <paragraph num="(e)"> <text>Approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Both hot and cold water shall be available in sufficient quantity for all plant operations and facilities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Handwashing Facilities.</text> <paragraph num="(1)"> <text>Convenient handwashing facilities shall be provided, including:</text> <paragraph num="(a)"> <text>Hot and cold or warm running water;</text> </paragraph> <paragraph num="(b)"> <text>Soap; and</text> </paragraph> <paragraph num="(c)"> <text>Individual sanitary towels or other approved hand-drying devices.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Handwashing facilities shall be kept in a clean condition and in good repair.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Plant Cleanliness.</text> <paragraph num="(1)"> <text>Rooms in which milk products, frozen dessert ingredients, and frozen desserts are handled, processed, stored, or packaged or in which containers, utensils, or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents.</text> </paragraph> <paragraph num="(2)"> <text>Only properly applied pesticides, approved by the State and federal agencies for pesticide control, shall be used.</text> </paragraph> <paragraph num="(3)"> <text>Only equipment directly related to processing and packaging operations, or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, packaging, and bulk milk storage rooms.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Construction and Repair of Containers and Equipment.</text> <paragraph num="(1)"> <text>Multiuse containers and equipment with which milk products, frozen dessert ingredients, and frozen desserts come into contact shall be:</text> <paragraph num="(a)"> <text>Of smooth, impervious, corrosion-resistant, nontoxic material;</text> </paragraph> <paragraph num="(b)"> <text>Constructed and installed for ease of cleaning; and</text> </paragraph> <paragraph num="(c)"> <text>Kept in good repair.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Single-service Containers.</text> <paragraph num="(a)"> <text>Single-service containers, closures, gaskets, and other articles with which milk products, frozen dessert ingredients, or frozen desserts come into contact shall:</text> <paragraph num="(i)"> <text>Be nontoxic; and</text> </paragraph> <paragraph num="(ii)"> <text>Have been manufactured, packaged, transported, and handled in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Articles intended for single-service use may not be reused.</text> </paragraph> <paragraph num="(c)"> <text>Equipment pertaining to materials, design, and finish shall comply with applicable 3-A Sanitary Standards.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Cleaning and Sanitizing of Containers and Equipment. The product-contact surface of all multiuse containers, utensils, and equipment used in the transportation, processing, handling, freezing, packaging, and storage of milk products, frozen dessert ingredients and frozen desserts mix shall be effectively cleaned and sanitized before each use.</text> </paragraph> <paragraph num="G."> <text>Storage of Cleaned Multiuse Containers and Equipment. After cleaning, multiuse milk products, frozen dessert ingredients, and frozen dessert containers, utensils, and equipment shall be:</text> <paragraph num="(1)"> <text>Transported and stored to assure complete drainage; and</text> </paragraph> <paragraph num="(2)"> <text>Protected from contamination before use.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Storage of Single-Service Containers, Utensils and Materials. Single-service parchment papers, containers, gaskets, and other single-service articles for use in contact with milk products, frozen dessert ingredients, or frozen desserts shall be:</text> <paragraph num="(1)"> <text>Purchased and stored in sanitary wrappings or cartons;</text> </paragraph> <paragraph num="(2)"> <text>Kept in a clean dry place until used; and</text> </paragraph> <paragraph num="(3)"> <text>Handled in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Protection from Contamination.</text> <paragraph num="(1)"> <text>Frozen desserts plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of:</text> <paragraph num="(a)"> <text>Milk products;</text> </paragraph> <paragraph num="(b)"> <text>Frozen dessert ingredients;</text> </paragraph> <paragraph num="(c)"> <text>Frozen desserts;</text> </paragraph> <paragraph num="(d)"> <text>Equipment;</text> </paragraph> <paragraph num="(e)"> <text>Containers; and</text> </paragraph> <paragraph num="(f)"> <text>Utensils.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the equipment has first been properly washed and subjected to a satisfactory bactericidal treatment, pasteurized mix or frozen desserts may not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, milk, or milk products have been in contact.</text> </paragraph> <paragraph num="(3)"> <text>In a frozen desserts plant, processing and handling shall be performed to preclude the contamination of the products.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Pasteurization.</text> <paragraph num="(1)"> <text>Frozen desserts shall be made from pasteurized mixes.</text> </paragraph> <paragraph num="(2)"> <text>After formulation of the entire mix except for flavoring, ingredients shall be pasteurized as provided in Regulation .21B(13) of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The design and operation of all pasteurization equipment and all appurtenances to it shall comply with the applicable specifications and operational procedures as outlined in Appendices H and I of the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Cooling of Milk Products and Frozen Desserts Mix.</text> <paragraph num="(1)"> <text>Raw milk products shall be maintained at 45°F or less until processed.</text> </paragraph> <paragraph num="(2)"> <text>Pasteurized milk products and frozen desserts mix shall be cooled immediately, in approved equipment, to a temperature of 45°F or less.</text> </paragraph> <paragraph num="(3)"> <text>Pasteurized milk and frozen desserts mix shall be stored at a temperature of 45°F or less and maintained at that temperature until further processed.</text> </paragraph> <paragraph num="(4)"> <text>A room or tank in which products or frozen desserts mix are stored shall be equipped with an accurate thermometer.</text> </paragraph> <paragraph num="(5)"> <text>A mix which is not frozen at the plant at which it is pasteurized shall be:</text> <paragraph num="(a)"> <text>Transported to the place of manufacturing or freezing in sealed containers;</text> </paragraph> <paragraph num="(b)"> <text>Handled in a sanitary manner; and</text> </paragraph> <paragraph num="(c)"> <text>Stored at a temperature of 45°F or less until frozen.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except for sampling, dipping from containers of pasteurized mix is prohibited.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Container Packaging, Closure, Sealing, and Storage.</text> <paragraph num="(1)"> <text>Closing or sealing of frozen desserts containers shall be done in a sanitary manner.</text> </paragraph> <paragraph num="(2)"> <text>The closing or sealing of individual containers of frozen desserts shall be done by methods which preclude product contamination.</text> </paragraph> <paragraph num="(3)"> <text>Frozen desserts shall be stored in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Personnel Cleanliness.</text> <paragraph num="(1)"> <text>Hand Washing.</text> <paragraph num="(a)"> <text>Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination.</text> </paragraph> <paragraph num="(b)"> <text>An employee may not resume work after visiting the toilet room without thoroughly washing the employee’s hands.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Garments and Hair Coverings.</text> <paragraph num="(a)"> <text>An individual engaged in processing, pasteurization, handling, storage, transportation, or packaging of milk products, frozen dessert ingredients or frozen desserts, containers, utensils, or equipment shall wear clean outer garments and a head covering.</text> </paragraph> <paragraph num="(b)"> <text>An employee with long hair shall wear hair restraints.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The use of tobacco by any person while engaged in the processing of milk products, frozen desserts ingredients, or frozen desserts is prohibited.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-2" heading="Frozen Desserts Plants — Operation and Transportation Requirements."> <paragraph num="A."> <text>Packaging, Overflow, and Spillage.</text> <paragraph num="(1)"> <text>Packaging.</text> <paragraph num="(a)"> <text>The filling of frozen desserts containers shall be done only by approved mechanical equipment or by methods which preclude contamination.</text> </paragraph> <paragraph num="(b)"> <text>Frozen desserts shall be packaged in containers which protect the contents from contamination.</text> </paragraph> <paragraph num="(c)"> <text>Frozen desserts or frozen desserts mix:</text> <paragraph num="(i)"> <text>May be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be stored in a sanitary manner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Milk products, frozen desserts, or their ingredients which have been spilled, overflowed, or leaked shall be discarded and may not be sold for human consumption.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Vehicles.</text> <paragraph num="(1)"> <text>Vehicles used for transportation of frozen desserts mix shall be constructed and operated so that the frozen desserts mix is:</text> <paragraph num="(a)"> <text>Maintained at 45°F or less; and</text> </paragraph> <paragraph num="(b)"> <text>Protected from;</text> <paragraph num="(i)"> <text>Sun;</text> </paragraph> <paragraph num="(ii)"> <text>Freezing; and</text> </paragraph> <paragraph num="(iii)"> <text>Contamination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Vehicles used for transportation of frozen desserts mix shall be kept clean.</text> </paragraph> <paragraph num="(3)"> <text>Substances capable of contaminating mix or frozen desserts or their ingredients may not be transported with frozen desserts mixes in a manner which permits contamination.</text> </paragraph> <paragraph num="(4)"> <text>Vehicles transporting frozen desserts or mix to wholesale or retail outlets shall have the name and address of the distributor prominently displayed on them.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Transferring and Dispensing Frozen Desserts.</text> <paragraph num="(1)"> <text>Except for in a sanitary room or enclosure under approved conditions a person may not:</text> <paragraph num="(a)"> <text>Transfer frozen desserts from one container to another; or</text> </paragraph> <paragraph num="(b)"> <text>Package frozen desserts:</text> <paragraph num="(i)"> <text>On the street; or</text> </paragraph> <paragraph num="(ii)"> <text>In any open vehicle.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The direct sale of frozen desserts in packages, cones, or servings to the consumer may take place at roadside stands or concessions where the sanitary conditions are approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Surroundings.</text> <paragraph num="(1)"> <text>Frozen desserts plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies or other insects and rodents, or which otherwise constitute a nuisance.</text> </paragraph> <paragraph num="(2)"> <text>Roads, driveways, yards, and parking areas adjacent to the plant shall be:</text> <paragraph num="(a)"> <text>Paved or otherwise treated to prevent dust; and</text> </paragraph> <paragraph num="(b)"> <text>Smooth and well drained to prevent accumulation of stagnant liquid.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Inspection of Frozen Dessert Plants."> <paragraph num="A."> <text>Upon application for a frozen desserts license, every plant shall be inspected to determine compliance with these regulations. Following the issuance of a license, every plant shall be inspected at least once every 3 months.</text> </paragraph> <paragraph num="B."> <text>If violations are found, notice shall be given as provided in the Frozen Desserts Law, Health-General Article, §21-813, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Every licensee shall permit access to all parts of the establishment, and shall furnish the Secretary upon his request, for official use only:</text> <paragraph num="(1)"> <text>A true statement of actual quantities of milk products, mix, or frozen desserts used or produced;</text> </paragraph> <paragraph num="(2)"> <text>Sources of milk products, ingredients, or mix;</text> </paragraph> <paragraph num="(3)"> <text>Inspection and tests;</text> </paragraph> <paragraph num="(4)"> <text>Past records; and</text> </paragraph> <paragraph num="(5)"> <text>Pertinent information as to persons employed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="License."> <paragraph num="A."> <text>Before engaging in the business of manufacturing any frozen desserts mix or frozen dessert regardless of the name under which the product is sold, every person shall first obtain a license from the Maryland Department of Health, Office of Environmental Programs, Division of Milk Control.</text> </paragraph> <paragraph num="B."> <text>Only a person who complies with the requirements of this regulation is entitled to receive and retain a license.</text> </paragraph> <paragraph num="C."> <text>Suspension — Revocation of License. A license may be suspended or revoked by the Secretary as follows:</text> <paragraph num="(1)"> <text>Upon the violation by the holder of any of the provisions of this law and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Immediately when an imminent health hazard is found to exist; or</text> </paragraph> <paragraph num="(3)"> <text>For interference with the Secretary in the performance of his duties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Sampling, Enforcement, and Reinstatement of License."> <paragraph num="A."> <text>Frequency of Sampling. Pursuant to Health-General Article, §21-804, Annotated Code of Maryland, during any consecutive 6-month period at least two samples of frozen desserts mix and frozen desserts shall be taken from each wholesale frozen dessert manufacturer. Samples of milk and milk products used as ingredients in frozen desserts shall be taken periodically.</text> </paragraph> <paragraph num="B."> <text>Enforcement.</text> <paragraph num="(1)"> <text>In accordance with Health-General Article, §21-813, Annotated Code of Maryland, the licensee shall be notified of violations.</text> </paragraph> <paragraph num="(2)"> <text>Whenever two of the last four consecutive samples of different batches of the same flavor of the same product, taken on separate days, exceed bacteria count, coliform determinations, or temperature standards as provided in Regulation .25 of this chapter, the licensee shall be notified of the results by mail and ordered to appear before the Secretary to review possible causes. At the same time, the licensee shall be warned that should the results of the next sample, collected within 14 days of the meeting, violate the standards by three of the last five bacteria counts, coliform determinations, or cooling temperatures, his license may be suspended. The suspension shall remain in effect so long as two of the last four consecutive samples exceed the limit of the standards.</text> </paragraph> <paragraph num="(3)"> <text>Failure to appear, without due notification, shall be cause for immediate suspension.</text> </paragraph> <paragraph num="(4)"> <text>Upon repeated violations, the Secretary may revoke a license following reasonable notice to the licensee and an opportunity for a hearing. This section is not intended to preclude the institution of court action. The Secretary may forego suspension of the license provided the product or products in violation are not sold, offered for sale, or given away.</text> </paragraph> <paragraph num="(5)"> <text>Whenever a phosphatase test is positive the cause shall be determined. When the cause is improper pasteurization, it shall be corrected and any product involved may not be sold, offered for sale, or given away.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement of License.</text> <paragraph num="(1)"> <text>In accordance with Health-General Article, §21-814, Annotated Code of Maryland, any license holder whose license has been suspended may make written application at any time for the reinstatement of his license. When the license suspension has been due to a violation of any of the bacteria, coliform, or cooling temperature standards, the Secretary, within 1 week after the receipt of a written application for reinstatement of license, shall issue a temporary license by letter, after determining by an inspection of the facilities and operation methods that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two per week on separate days within a 3-week period, and the Secretary shall reinstate the license upon compliance with the appropriate standard as determined in accordance with §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Whenever the license suspension has been due to a violation of a requirement other than the bacteriological, coliform, or cooling temperature standards, the application shall contain a written statement of the effect that the violation has been corrected. Within 1 week of the receipt of the application, the Secretary shall make an inspection of the applicant's establishment and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements.</text> </paragraph> <paragraph num="(3)"> <text>When the findings justify, the license shall be reinstated.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Frozen Desserts and Frozen Desserts Mix Which May Be Sold."> <text>Only frozen desserts and frozen desserts mix manufactured by a licensed wholesale frozen desserts manufacturer or retail frozen desserts manufacturer shall be sold to the final consumer, or to restaurants, soda fountains, grocery stores, or similar establishments.</text> </regulation> <regulation prefix="Regulation" num=".31" heading="Future Frozen Desserts Plants: Submission of Plans."> <text>Properly prepared plans for all frozen desserts plants regulated under these regulations, which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the Secretary for written approval before work is begun.</text> </regulation> <regulation prefix="Regulation" num=".32" heading="Personnel Health."> <paragraph num="A."> <text>A person affected with any disease in a communicable form, or who is a carrier of a communicable disease, may not work at any frozen desserts plant in any capacity which brings him in contact with the production, handling, storage, or transportation of milk, milk products, other frozen dessert ingredients, frozen desserts, or frozen desserts mix containers, equipment, and utensils.</text> </paragraph> <paragraph num="B."> <text>A plant operator may not employ in this capacity any infected person, or any person suspected of having any disease in a communicable form, or of being a carrier of a communicable disease.</text> </paragraph> <paragraph num="C."> <text>Any permit holder, in whose frozen desserts plant any communicable disease occurs, or who suspects that any employee has contracted any disease in any form, or has become a carrier of a disease, shall notify the Secretary immediately.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Procedure when Infection is Suspected."> <text>When reasonable cause exists to suspect the possibility of transmission of infection from any person concerned with the handling of milk, milk products, other than frozen dessert ingredients, frozen desserts, or frozen desserts mix, the Secretary is authorized to require any or all of the following measures:</text> <paragraph num="(1)"> <text>The immediate exclusion of that person from product handling;</text> </paragraph> <paragraph num="(2)"> <text>The immediate exclusion of the products concerned from distribution and use; and</text> </paragraph> <paragraph num="(3)"> <text>Adequate medical and bacteriological examination of the person, of his associates, and of his and their body discharges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Dispensing Freezers When Used in Food Service Facilities."> <text>When a dispensing freezer is used in a food service facility, it shall be exempt from the provisions of Regulations .22 — .24, .26 — .33, and .35 of this chapter. The operation and maintenance of this equipment shall comply with the provisions of COMAR 10.15.03.</text> </regulation> <regulation prefix="Regulation" num=".35" heading="Retail Frozen Desserts Manufacturers."> <text>Retail frozen dessert manufacturers shall be exempt from the provisions of Regulations .22—.24, .26—.27 and .31—.33 under this chapter. The sanitation requirements and operation and maintenance of equipment of retail frozen dessert manufacturers shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall manufacture frozen desserts from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §21-804, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 15, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulations .25A, .26U, and .27A amended effective August 25, 1978 (5:17 Md. R. 1330)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 12, 1981 (8:12 Md. R. 1062)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02C, .14, .21B, .25G, H, I, .29A, and .30 amended effective January 12, 1987 (14:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulations .10-1, .20-1, .20-2, and .20-3 adopted effective January 12, 1987 (14:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21B amended effective January 2, 1994 (20:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25A amended effective January 2, 1994 (20:26 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35 repealed and new regulation .35 adopted effective January 12, 1987 (14:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 27, 2017 (44:4 Md. R. 254)</annotation> </annotations> </chapter> <chapter num="06" heading="Production, Processing, Transportation, Storage, and Distribution of Grade “A” Milk"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Governs permits for the sale of Grade “A” milk and milk products, as set forth in Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Requires a permit for the sale of Grade “A” milk and milk products;</text> </paragraph> <paragraph num="C."> <text>Regulates the inspection of Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and</text> </paragraph> <paragraph num="D."> <text>Sets forth:</text> <paragraph num="(1)"> <text>Standards for Grade “A” milk and milk products;</text> </paragraph> <paragraph num="(2)"> <text>The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of Grade “A” milk and milk products;</text> </paragraph> <paragraph num="(3)"> <text>Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Requirements for Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Bobtailer” means a person who operates or controls a Grade “A” milk route, and distributes Grade “A” pasteurized milk products that the person buys from a Grade “A” distributor or milk processor.</text> </paragraph> <paragraph num="(2)"> <text>“Bulk milk hauler/sampler” means a person who:</text> <paragraph num="(a)"> <text>Collects official samples;</text> </paragraph> <paragraph num="(b)"> <text>Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station;</text> </paragraph> <paragraph num="(c)"> <text>Possesses a permit from any state to sample raw milk or raw milk products; and</text> </paragraph> <paragraph num="(d)"> <text>Possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Certified industry dairy farm inspector” means an individual who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to carry out the inspections of dairy farms.</text> </paragraph> <paragraph num="(4)"> <text>“Dairy farm” means a place where at least one cow, goat, or other hoofed mammal is kept, and from which the milk is sold or offered for sale.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(6)"> <text>“Extensive alteration” means the adding or tearing down of walls, plumbing, or other structural components of a dairy farm or milk plant.</text> </paragraph> <paragraph num="(7)"> <text>“Grade “A” distribution station” means a place or vehicle where, for redistribution and sale, Grade “A” pasteurized milk products routinely are received, stored, or transferred.</text> </paragraph> <paragraph num="(8)"> <text>“Grade “A” fluid milk” means pasteurized homogenized or pasteurized non-homogenized Grade “A” milk, cream, or half and half that has been processed to produce whole milk, low fat milk, or nonfat milk.</text> </paragraph> <paragraph num="(9)"> <text>“Grade “A” milk or milk products” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="(10)"> <text>“Impound” means to detain and hold milk or milk products under the authority of the Secretary, as provided under Health-General Article, §21-428, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Improper handling” means Grade “A” milk or a milk product intended for human consumption that:</text> <paragraph num="(a)"> <text>Has been adulterated;</text> </paragraph> <paragraph num="(b)"> <text>Has been misbranded;</text> </paragraph> <paragraph num="(c)"> <text>Has not been kept at the required temperature;</text> </paragraph> <paragraph num="(d)"> <text>Is injurious to health if consumed; or</text> </paragraph> <paragraph num="(e)"> <text>Is otherwise unsafe.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station.</text> </paragraph> <paragraph num="(13)"> <text>“Milk” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="(14)"> <text>“Milk facility” means a:</text> <paragraph num="(a)"> <text>Milk plant;</text> </paragraph> <paragraph num="(b)"> <text>Grade “A” distribution station;</text> </paragraph> <paragraph num="(c)"> <text>Receiving station;</text> </paragraph> <paragraph num="(d)"> <text>Transfer station;</text> </paragraph> <paragraph num="(e)"> <text>Milk processor; or</text> </paragraph> <paragraph num="(f)"> <text>Milk tank truck cleaning facility.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.</text> </paragraph> <paragraph num="(16)"> <text>Milk Plant.</text> <paragraph num="(a)"> <text>“Milk plant” means a place where, for distribution, milk products are:</text> <paragraph num="(i)"> <text>Processed;</text> </paragraph> <paragraph num="(ii)"> <text>Pasteurized;</text> </paragraph> <paragraph num="(iii)"> <text>Bottled or packaged; or</text> </paragraph> <paragraph num="(iv)"> <text>Prepared.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Milk plant” does not include a place where milk products are sold at retail only.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Milk processor” means a person who owns, operates, or controls a milk plant.</text> </paragraph> <paragraph num="(18)"> <text>“Milk producer” means a person who:</text> <paragraph num="(a)"> <text>Operates a dairy farm; and</text> </paragraph> <paragraph num="(b)"> <text>Provides, sells, or offers milk for sale to a:</text> <paragraph num="(i)"> <text>Milk plant;</text> </paragraph> <paragraph num="(ii)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(iii)"> <text>Transfer station.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.</text> </paragraph> <paragraph num="(20)"> <text>“Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized.</text> </paragraph> <paragraph num="(21)"> <text>“Milk transportation company” means a person who is responsible for a milk tank truck.</text> </paragraph> <paragraph num="(22)"> <text>“Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.</text> </paragraph> <paragraph num="(23)"> <text>“Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of:</text> <paragraph num="(a)"> <text>Producer samples of Grade “A” raw milk for pasteurization; or</text> </paragraph> <paragraph num="(b)"> <text>Commingled milk tank truck samples of Grade “A” raw milk.</text> </paragraph> </paragraph> <paragraph num="(23-1)"> <text>“On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.</text> </paragraph> <paragraph num="(23-2)"> <text>Pasteurization.</text> <paragraph num="(a)"> <text>“Pasteurization” has the meaning stated in 21 CFR §131.3.</text> </paragraph> <paragraph num="(b)"> <text>“Pasteurization” includes any other process found equivalent to pasteurization for milk and milk products as stated in 21 U.S.C. §343(h)</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Permit” means an official document issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit.</text> </paragraph> <paragraph num="(25)"> <text>“Permittee” means a person who holds a permit.</text> </paragraph> <paragraph num="(26)"> <text>Person.</text> <paragraph num="(a)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(b)"> <text>“Person” includes:</text> <paragraph num="(i)"> <text>An operator of a facility that is owned by a State or local unit of government; or</text> </paragraph> <paragraph num="(ii)"> <text>A State or local unit of government if the State or local unit of government is the operator of the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Raw milk” means unpasteurized milk.</text> </paragraph> <paragraph num="(28)"> <text>“Receiving station” means a place where, for delivery to a milk plant, raw milk is collected, cooled, and stored.</text> </paragraph> <paragraph num="(29)"> <text>“Sale” or “sell” means a transaction that involves the:</text> <paragraph num="(a)"> <text>Transfer, dispensing, or serving of milk and milk products with or without charge; or</text> </paragraph> <paragraph num="(b)"> <text>Right to acquire milk and milk products:</text> <paragraph num="(i)"> <text>Through barter or contractual arrangement; or</text> </paragraph> <paragraph num="(ii)"> <text>In exchange for any other form of compensation including, but not limited to, an agistment agreement, which is the sale of shares or interest in a cow, goat, or other lactating hoofed mammal, or herd of cows, goats, or other lactating hoofed mammals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms.</text> </paragraph> <paragraph num="(31)"> <text>“Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year.</text> </paragraph> <paragraph num="(32)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(33)"> <text>“Sell-by date” means the end of the sell-by period.</text> </paragraph> <paragraph num="(34)"> <text>“Transfer station” means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant.</text> </paragraph> <paragraph num="(35)"> <text>“Ultra-pasteurization” means the process of heating milk or milk product in properly designed and operated equipment to a minimum of 280°F for at minimum two seconds, either before or after packaging, so as to produce a milk or milk product which has an extended shelf-life under refrigerated conditions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter the following documents are incorporated by reference:</text> <paragraph num="A."> <text>Grade “A” Pasteurized Milk Ordinance, 20239evision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration);</text> </paragraph> <paragraph num="B."> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f, as amended;</text> </paragraph> <paragraph num="C."> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;</text> </paragraph> <paragraph num="D."> <text>FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended; and;</text> </paragraph> <paragraph num="E."> <text>21 CFR §§130—131, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Requirements."> <paragraph num="A."> <text>The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth at and in compliance with the standards, requirements, and procedures specified at:</text> <paragraph num="(1)"> <text>Health-General Article, Title 21, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text> </paragraph> <paragraph num="(3)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(4)"> <text>Grade “A” Pasteurized Milk Ordinance; and</text> </paragraph> <paragraph num="(5)"> <text>FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person engaged in an occupation involving Grade “A” milk shall conduct all Grade “A” milk activities as set forth at and in compliance with the standards, requirements, and procedures specified at:</text> <paragraph num="(1)"> <text>Health-General Article, Title 21, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text> </paragraph> <paragraph num="(3)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535); and</text> </paragraph> <paragraph num="(4)"> <text>Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards for Milk Products."> <paragraph num="A."> <text>A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards, requirements, and procedures established by the:</text> <paragraph num="(1)"> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text> </paragraph> <paragraph num="(2)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(3)"> <text>Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A bulk milk hauler/sampler shall ensure that:</text> <paragraph num="(1)"> <text>Bulk raw milk is delivered or received by the processor or receiving station within 12 hours of pickup route completion;</text> </paragraph> <paragraph num="(2)"> <text>Bulk raw milk is picked up from every dairy farm at least once every 72 hours; and;</text> </paragraph> <paragraph num="(3)"> <text>The temperature of the bulk raw milk does not exceed 45F.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The person in charge of an official laboratory or officially designated laboratory shall ensure that:</text> <paragraph num="(1)"> <text>The laboratory is operated according to the requirements established by the Grade “A” Pasteurized Milk Ordinance; and</text> </paragraph> <paragraph num="(2)"> <text>All raw milk for pasteurization, all pasteurized milk and milk products, and all dairy product containers and lids are tested according to the requirements established by the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Permits Required."> <paragraph num="A."> <text>Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may:</text> <paragraph num="(1)"> <text>Be a:</text> <paragraph num="(a)"> <text>Bobtailer;</text> </paragraph> <paragraph num="(b)"> <text>Bulk milk hauler/sampler;</text> </paragraph> <paragraph num="(c)"> <text>Certified industry dairy farm inspector;</text> </paragraph> <paragraph num="(d)"> <text>Milk processor;</text> </paragraph> <paragraph num="(e)"> <text>Milk producer; or</text> </paragraph> <paragraph num="(f)"> <text>Seasonal milk producer; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Operate a:</text> <paragraph num="(a)"> <text>Grade “A” distribution station;</text> </paragraph> <paragraph num="(b)"> <text>Milk tank truck cleaning facility;</text> </paragraph> <paragraph num="(c)"> <text>Milk transportation company;</text> </paragraph> <paragraph num="(d)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(e)"> <text>Transfer station.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, for a milk tank truck.</text> </paragraph> <paragraph num="C."> <text>Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:</text> <paragraph num="(1)"> <text>A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area;</text> </paragraph> <paragraph num="(3)"> <text>A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if:</text> <paragraph num="(i)"> <text>The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and</text> </paragraph> <paragraph num="(ii)"> <text>The milk product is received from a permittee; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual who only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inspection and Evaluation of Milk Production and Transportation."> <paragraph num="A."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect:</text> <paragraph num="(1)"> <text>A milk tank truck;</text> </paragraph> <paragraph num="(2)"> <text>A milk producer;</text> </paragraph> <paragraph num="(3)"> <text>A seasonal milk producer;</text> </paragraph> <paragraph num="(4)"> <text>A transfer station;</text> </paragraph> <paragraph num="(5)"> <text>A milk tank truck cleaning facility;</text> </paragraph> <paragraph num="(6)"> <text>A milk plant; and</text> </paragraph> <paragraph num="(7)"> <text>A receiving station.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until production of milk for sale has ceased.</text> </paragraph> <paragraph num="C."> <text>The Secretary shall inspect a Grade “A” distribution station at least once every 6 months.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall inspect a bobtailer at least once every 12 months.</text> </paragraph> <paragraph num="E."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall evaluate:</text> <paragraph num="(1)"> <text>The ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling;</text> </paragraph> <paragraph num="(2)"> <text>The pick-up and sampling procedures that a bulk milk hauler/sampler performs; and</text> </paragraph> <paragraph num="(3)"> <text>The sampling procedures of the industry plant sampler.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Secretary shall inspect and evaluate a bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B.</text> </paragraph> <paragraph num="G."> <text>The Secretary shall inspect a milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance and Appendix B.</text> </paragraph> <paragraph num="H."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N, the Secretary shall evaluate:</text> <paragraph num="(1)"> <text>Laboratories performing Grade “A” milk product testing for official use;</text> </paragraph> <paragraph num="(2)"> <text>Laboratories performing drug residue testing; and</text> </paragraph> <paragraph num="(3)"> <text>Laboratory analysts performing testing as required by the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Improper Handling of Milk Products."> <paragraph num="A."> <text>Under Health-General Article, §21-428, Annotated Code of Maryland, and to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall impound Grade A milk or milk products intended for human consumption due to improper handling.</text> </paragraph> <paragraph num="B."> <text>After impounding the Grade A milk or milk product, the Secretary may issue an order to:</text> <paragraph num="(1)"> <text>Dispose of the milk or milk product;</text> </paragraph> <paragraph num="(2)"> <text>Make the milk or milk product unusable for consumption; or</text> </paragraph> <paragraph num="(3)"> <text>Under Health-General Article, §21-428, Annotated Code of Maryland, impose a civil monetary penalty, as set forth in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents.</text> </paragraph> <paragraph num="D."> <text>A person subject to an impoundment order may seek legal recourse as set forth at Health-General Article, §21-428, Annotated Code of Maryland, by:</text> <paragraph num="(1)"> <text>Appealing a civil penalty; or</text> </paragraph> <paragraph num="(2)"> <text>Bringing an action for damages.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Labeling of Milk."> <text>A permittee shall ensure that milk product labels conform to the standards and requirements established by the:</text> <paragraph num="A."> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f;</text> </paragraph> <paragraph num="B."> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="C."> <text>Grade “A” Pasteurized Milk Ordinance; and</text> </paragraph> <paragraph num="D."> <text>Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Dating of Grade “A” Fluid Milk."> <paragraph num="A."> <text>Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing.</text> </paragraph> <paragraph num="B."> <text>In order to sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing, an applicant shall:</text> <paragraph num="(1)"> <text>Submit to the Department:</text> <paragraph num="(a)"> <text>A written request; and</text> </paragraph> <paragraph num="(b)"> <text>A shelf life study to show that the product meets standards set forth in this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be approved by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A permittee shall conspicuously and legibly mark the cap or non-glass container of Grade “A” fluid milk with the words “Sell by”, followed by the designation of the month and the day of the month after which the product may not be sold, delivered, or offered for sale.</text> </paragraph> <paragraph num="D."> <text>Milk products exempt from dating requirements are:</text> <paragraph num="(1)"> <text>Cultured milk products and eggnog;</text> </paragraph> <paragraph num="(2)"> <text>Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging; and</text> </paragraph> <paragraph num="(3)"> <text>Milk and dairy products as defined in 21 CFR §131.3(c), which have been subjected to ultra-pasteurization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Sale and Handling of Milk by Food Service Facilities."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a person may not offer Grade “A” fluid milk for sale beyond the sell-by date.</text> </paragraph> <paragraph num="B."> <text>The following establishments may use or serve Grade “A” fluid milk up to 4 days beyond the sell-by date:</text> <paragraph num="(1)"> <text>Food service facilities;</text> </paragraph> <paragraph num="(2)"> <text>Hospitals;</text> </paragraph> <paragraph num="(3)"> <text>Schools;</text> </paragraph> <paragraph num="(4)"> <text>Institutions; and</text> </paragraph> <paragraph num="(5)"> <text>Places where milk is consumed on the premises.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An establishment listed in §B of this regulation shall ensure that Grade “A” fluid milk is used by the establishment not later than 4 days beyond the sell-by date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Sale of Raw Milk."> <paragraph num="A."> <text>Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption.</text> </paragraph> <paragraph num="B."> <text>A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:</text> <paragraph num="(1)"> <text>Receiving station;</text> </paragraph> <paragraph num="(2)"> <text>Transfer station;</text> </paragraph> <paragraph num="(3)"> <text>Milk plant; or</text> </paragraph> <paragraph num="(4)"> <text>Milk marketing agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Dairy Farm Construction and Plan Submission."> <text>Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department:</text> <paragraph num="A."> <text>A plan and specifications before:</text> <paragraph num="(1)"> <text>Constructing or reconstructing a milk house, milking barn, milking stable, or milking parlor;</text> </paragraph> <paragraph num="(2)"> <text>Converting or remodeling an existing building or structure for use as a milk house, milking barn, milking stable, or milking parlor; or</text> </paragraph> <paragraph num="(3)"> <text>Adding, modifying, or replacing:</text> <paragraph num="(a)"> <text>A bulk milk tank;</text> </paragraph> <paragraph num="(b)"> <text>A milking system;</text> </paragraph> <paragraph num="(c)"> <text>Any part of a milking system;</text> </paragraph> <paragraph num="(d)"> <text>A washing system;</text> </paragraph> <paragraph num="(e)"> <text>Any part of a washing system; or</text> </paragraph> <paragraph num="(f)"> <text>A cooling system, including a plate cooler or bulk tank cooling system; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;</text> </paragraph> <paragraph num="C."> <text>Contact information for the dairy farm, including:</text> <paragraph num="(1)"> <text>The full name, title, and telephone number of each applicant;</text> </paragraph> <paragraph num="(2)"> <text>The name of the dairy farm;</text> </paragraph> <paragraph num="(3)"> <text>The mailing address;</text> </paragraph> <paragraph num="(4)"> <text>The location; and</text> </paragraph> <paragraph num="(5)"> <text>Directions to the site;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A site drawing showing the location of the milk house, milking barn, milking stable, milking parlor, and each animal housing area, with approximate distances in feet, to:</text> <paragraph num="(1)"> <text>Manure pits;</text> </paragraph> <paragraph num="(2)"> <text>Cow yards;</text> </paragraph> <paragraph num="(3)"> <text>Silos;</text> </paragraph> <paragraph num="(4)"> <text>Wells or other approved water systems;</text> </paragraph> <paragraph num="(5)"> <text>Septic systems;</text> </paragraph> <paragraph num="(6)"> <text>Frost free style watering hydrants;</text> </paragraph> <paragraph num="(7)"> <text>Ditches; and</text> </paragraph> <paragraph num="(8)"> <text>Streams;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A detailed drawing of the interior of the milk house, milking barn, milking stable, milking parlor, and each animal housing area indicating dimensions and showing the location of:</text> <paragraph num="(1)"> <text>Equipment;</text> </paragraph> <paragraph num="(2)"> <text>Pre-coolers;</text> </paragraph> <paragraph num="(3)"> <text>Floor drains;</text> </paragraph> <paragraph num="(4)"> <text>Lighting;</text> </paragraph> <paragraph num="(5)"> <text>Hose bibs;</text> </paragraph> <paragraph num="(6)"> <text>Watering troughs;</text> </paragraph> <paragraph num="(7)"> <text>Frost free style watering hydrants;</text> </paragraph> <paragraph num="(8)"> <text>Washing systems;</text> </paragraph> <paragraph num="(9)"> <text>Chemical dispensers;</text> </paragraph> <paragraph num="(10)"> <text>Compressors;</text> </paragraph> <paragraph num="(11)"> <text>Back flow prevention devices; and</text> </paragraph> <paragraph num="(12)"> <text>Toilets;</text> </paragraph> </paragraph> <paragraph num="F."> <text>For pipeline and milking system installations:</text> <paragraph num="(1)"> <text>The make, model number, quantity, and specifications of milking equipment including pipeline and milking units;</text> </paragraph> <paragraph num="(2)"> <text>The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute;</text> </paragraph> <paragraph num="(3)"> <text>A drawing of the parlor or barn showing the location of:</text> <paragraph num="(a)"> <text>Milking equipment;</text> </paragraph> <paragraph num="(b)"> <text>Pipeline, including size and length of the piping;</text> </paragraph> <paragraph num="(c)"> <text>Wash line, including size and length of the wash line;</text> </paragraph> <paragraph num="(d)"> <text>Receiver, if applicable;</text> </paragraph> <paragraph num="(e)"> <text>Pre-cooler, if applicable;</text> </paragraph> <paragraph num="(f)"> <text>Any other milk equipment; and</text> </paragraph> <paragraph num="(g)"> <text>The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A description and diagram of the location of the back flow protection methods or devices that will be installed to protect the potable water supply on all plate coolers, chemical pumps, water lines, and other fixtures;</text> </paragraph> <paragraph num="(5)"> <text>The type, such as gas or electric, and capacity of the hot water heating system; and</text> </paragraph> <paragraph num="(6)"> <text>Information and specifications for booster or supplemental heating systems, if utilized;</text> </paragraph> </paragraph> <paragraph num="G."> <text>For bulk tank/milk cooling systems installation:</text> <paragraph num="(1)"> <text>A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank;</text> </paragraph> <paragraph num="(2)"> <text>Specific floor, wall, and ceiling finishes, if part of a new installation;</text> </paragraph> <paragraph num="(3)"> <text>Bulk tank specifications, including make, model number, and capacity;</text> </paragraph> <paragraph num="(4)"> <text>Cooling system specifications, including make, model number, and capacity; and</text> </paragraph> <paragraph num="(5)"> <text>Pre-cooler type and British thermal units capability, if applicable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Dairy Farm Requirements."> <text>A milk producer shall ensure that:</text> <paragraph num="A."> <text>Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .13 of this chapter, as applicable;</text> </paragraph> <paragraph num="B."> <text>Water used at a dairy farm shall:</text> <paragraph num="(1)"> <text>Be obtained from a water supply system that complies with:</text> <paragraph num="(a)"> <text>Environment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 26.04.04; and</text> </paragraph> <paragraph num="(c)"> <text>The Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be installed in a manner that prevents backflow or back-siphoning;</text> </paragraph> <paragraph num="(3)"> <text>Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;</text> </paragraph> <paragraph num="(4)"> <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text> </paragraph> <paragraph num="(5)"> <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Hand sinks shall have:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Hot and cold running water under pressure; or</text> </paragraph> <paragraph num="(b)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supply of hand-cleaning soap or detergent; and</text> </paragraph> <paragraph num="(3)"> <text>A sanitary means of drying hands, such as individual towels or a hand-drying device;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="E."> <text>Toilet facilities, if any, are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="F."> <text>Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and</text> </paragraph> <paragraph num="G."> <text>Electrical systems comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Milk Facility Construction and Plan Submission."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:</text> <paragraph num="A."> <text>Plans and specifications before:</text> <paragraph num="(1)"> <text>Constructing, reconstructing, or extensively altering a milk facility;</text> </paragraph> <paragraph num="(2)"> <text>Converting or remodeling an existing building or structure for use as a milk facility;</text> </paragraph> <paragraph num="(3)"> <text>Adding, replacing, relocating, or modifying a milk facility process; or</text> </paragraph> <paragraph num="(4)"> <text>Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work.</text> </paragraph> <paragraph num="C."> <text>Contact information for the facility, including:</text> <paragraph num="(1)"> <text>The full name, title, and telephone number of each applicant;</text> </paragraph> <paragraph num="(2)"> <text>The name of the plant;</text> </paragraph> <paragraph num="(3)"> <text>The mailing address;</text> </paragraph> <paragraph num="(4)"> <text>The location; and</text> </paragraph> <paragraph num="(5)"> <text>Directions to the site;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A narrative describing the scope and purpose of the project, including a projected time line from start to completion;</text> </paragraph> <paragraph num="E."> <text>An estimate of finished product output per day;</text> </paragraph> <paragraph num="F."> <text>Sample product labels for each product;</text> </paragraph> <paragraph num="G."> <text>A list of:</text> <paragraph num="(1)"> <text>All products to be produced;</text> </paragraph> <paragraph num="(2)"> <text>Raw cream and skim, condensed, or any other milk or milk products to be sold; and</text> </paragraph> <paragraph num="(3)"> <text>Single service container sources;</text> </paragraph> </paragraph> <paragraph num="H."> <text>A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:</text> <paragraph num="(1)"> <text>Processing;</text> </paragraph> <paragraph num="(2)"> <text>Chemical storage;</text> </paragraph> <paragraph num="(3)"> <text>Dry storage;</text> </paragraph> <paragraph num="(4)"> <text>Ingredient and product storage;</text> </paragraph> <paragraph num="(5)"> <text>Receiving;</text> </paragraph> <paragraph num="(6)"> <text>Load out;</text> </paragraph> <paragraph num="(7)"> <text>Laboratories;</text> </paragraph> <paragraph num="(8)"> <text>Offices;</text> </paragraph> <paragraph num="(9)"> <text>Restroom facilities;</text> </paragraph> <paragraph num="(10)"> <text>Lockers or a facility for the storage of personal items; and</text> </paragraph> <paragraph num="(11)"> <text>Employees to eat and drink beverages;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A scale drawing showing the location of all equipment, including:</text> <paragraph num="(1)"> <text>Pasteurizers and sterile systems;</text> </paragraph> <paragraph num="(2)"> <text>Milk processing equipment;</text> </paragraph> <paragraph num="(3)"> <text>Fillers;</text> </paragraph> <paragraph num="(4)"> <text>Raw and pasteurized tanks and silos;</text> </paragraph> <paragraph num="(5)"> <text>Clean-in-place (CIP) systems;</text> </paragraph> <paragraph num="(6)"> <text>Glycol water tanks;</text> </paragraph> <paragraph num="(7)"> <text>Recirculating cooling water tanks;</text> </paragraph> <paragraph num="(8)"> <text>Boilers;</text> </paragraph> <paragraph num="(9)"> <text>Boiler makeup tanks;</text> </paragraph> <paragraph num="(10)"> <text>Culinary steam systems; and</text> </paragraph> <paragraph num="(11)"> <text>Blow mold systems;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A scale drawing showing the location of plumbing and plumbing fixtures, including:</text> <paragraph num="(1)"> <text>Water lines;</text> </paragraph> <paragraph num="(2)"> <text>Sewer lines;</text> </paragraph> <paragraph num="(3)"> <text>Hand sinks;</text> </paragraph> <paragraph num="(4)"> <text>Toilets;</text> </paragraph> <paragraph num="(5)"> <text>Utility sinks;</text> </paragraph> <paragraph num="(6)"> <text>Utensil washing sinks;</text> </paragraph> <paragraph num="(7)"> <text>Floor drains;</text> </paragraph> <paragraph num="(8)"> <text>Floor sinks;</text> </paragraph> <paragraph num="(9)"> <text>Hose stations; and</text> </paragraph> <paragraph num="(10)"> <text>All back flow prevention devices;</text> </paragraph> </paragraph> <paragraph num="K."> <text>A legend for each drawing;</text> </paragraph> <paragraph num="L."> <text>Specifications for:</text> <paragraph num="(1)"> <text>Ventilation including, but not limited to, the type and location of:</text> <paragraph num="(a)"> <text>An air filter;</text> </paragraph> <paragraph num="(b)"> <text>An air pump; and</text> </paragraph> <paragraph num="(c)"> <text>A compressor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Construction materials for the building and interior finishes; and</text> </paragraph> <paragraph num="(3)"> <text>Pasteurizer plate coolers, if separate from the pasteurization system;</text> </paragraph> </paragraph> <paragraph num="M."> <text>A list and description of all boiler, glycol, and recirculating water additives and water treatment;</text> </paragraph> <paragraph num="N."> <text>A description of the:</text> <paragraph num="(1)"> <text>Type of disposal for wastewater and sewage;</text> </paragraph> <paragraph num="(2)"> <text>Source and system for the facility’s potable water supply;</text> </paragraph> <paragraph num="(3)"> <text>Lighting fixtures and placement; and</text> </paragraph> <paragraph num="(4)"> <text>Recirculating cooling system;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Specification sheets, including manufacturer and model number of all milk facility equipment;</text> </paragraph> <paragraph num="P."> <text>A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including:</text> <paragraph num="(1)"> <text>Reclamation systems;</text> </paragraph> <paragraph num="(2)"> <text>Standardization procedures or formulation procedures, or both;</text> </paragraph> <paragraph num="(3)"> <text>Vitamin addition protocol; and</text> </paragraph> <paragraph num="(4)"> <text>Draining of product lines;</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component;</text> </paragraph> <paragraph num="R."> <text>Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;</text> </paragraph> <paragraph num="S."> <text>Information and drawings on how separation from product lines will be accomplished, if applicable;</text> </paragraph> <paragraph num="T."> <text>Written step-by-step standard operating procedures for:</text> <paragraph num="(1)"> <text>Receiving, processing, storing, and packaging of each project;</text> </paragraph> <paragraph num="(2)"> <text>Drug residue testing;</text> </paragraph> <paragraph num="(3)"> <text>Cleaning and sanitization for all equipment;</text> </paragraph> <paragraph num="(4)"> <text>Cleaning and sanitization for the facility;</text> </paragraph> <paragraph num="(5)"> <text>Product trace back, inclusive of production or make sheet; and</text> </paragraph> <paragraph num="(6)"> <text>Product recall;</text> </paragraph> </paragraph> <paragraph num="U."> <text>A pest control program; and</text> </paragraph> <paragraph num="V."> <text>Employee training and personal hygiene practices.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Milk Physical Plant Requirements."> <paragraph num="A."> <text>Water used at a milk facility shall:</text> <paragraph num="(1)"> <text>Be obtained from a potable water supply system that complies with:</text> <paragraph num="(a)"> <text>Environment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 26.04.04; and</text> </paragraph> <paragraph num="(c)"> <text>The Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be installed in a manner that prevents backflow or back-siphoning; and</text> </paragraph> <paragraph num="(3)"> <text>Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;</text> </paragraph> <paragraph num="(4)"> <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text> </paragraph> <paragraph num="(5)"> <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hand sinks shall have:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Hot and cold running water under pressure; or</text> </paragraph> <paragraph num="(b)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supply of hand-cleaning soap or detergent; and</text> </paragraph> <paragraph num="(3)"> <text>A sanitary means of drying hands, such as individual towels or a hand-drying device.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="D."> <text>Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.</text> </paragraph> <paragraph num="E."> <text>Toilet facilities shall:</text> <paragraph num="(1)"> <text>Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="(2)"> <text>For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and</text> </paragraph> <paragraph num="(3)"> <text>For a milk plant that is an on-farm processor, if not located within the physical plant building:</text> <paragraph num="(a)"> <text>Be located within 500 feet of the physical plant building;</text> </paragraph> <paragraph num="(b)"> <text>Be accessible at all times that the plant is in operation;</text> </paragraph> <paragraph num="(c)"> <text>Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and</text> </paragraph> <paragraph num="(d)"> <text>Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of COMAR 26.04.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Electrical systems at the facility shall:</text> <paragraph num="(1)"> <text>Comply with State and local electrical laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where:</text> <paragraph num="(a)"> <text>Milk or milk products are handled, processed, packaged, or stored; or</text> </paragraph> <paragraph num="(b)"> <text>Containers, utensils, and equipment are washed; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Plan Review Approval."> <paragraph num="A."> <text>An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .13—.16 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .13—.16 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the applicant:</text> <paragraph num="(a)"> <text>That the plan has been received;</text> </paragraph> <paragraph num="(b)"> <text>If additional information is required to complete the plant review;</text> </paragraph> <paragraph num="(c)"> <text>Whether the plan is approved or denied; and</text> </paragraph> <paragraph num="(d)"> <text>Of the appeal process if the plan is denied.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Confidentiality."> <text>The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Suspension and Revocation of Permits."> <paragraph num="A."> <text>When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §21-211, 21-418, or 21-419, Annotated Code of Maryland or the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.</text> </paragraph> <paragraph num="D."> <text>If a permit has been suspended more than once, the Secretary may revoke the permit.</text> </paragraph> <paragraph num="E."> <text>The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.</text> </paragraph> <paragraph num="F."> <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:</text> <paragraph num="(1)"> <text>Department shall:</text> <paragraph num="(a)"> <text>Summarily suspend the permit;</text> </paragraph> <paragraph num="(b)"> <text>Order the permittee to cease operation immediately; and</text> </paragraph> <paragraph num="(c)"> <text>Promptly provide the permittee with:</text> <paragraph num="(i)"> <text>A written notice of the suspension of the permit;</text> </paragraph> <paragraph num="(ii)"> <text>The reasons for the suspension; and</text> </paragraph> <paragraph num="(iii)"> <text>An opportunity to be heard; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Permittee shall immediately cease operation upon the receipt of the summary suspension order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Appeals Process."> <text>In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been:</text> <paragraph num="A."> <text>Denied;</text> </paragraph> <paragraph num="B."> <text>Suspended; or</text> </paragraph> <paragraph num="C."> <text>Revoked.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, and 21-428, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1972</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .03A amended effective February 2, 1977 (4:3 Md. R. 145)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01AA, FF adopted effective August 25, 1978 (5:17 Md. R. 1330)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-2 adopted effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 25, 1978 (5:17 Md. R. 1330)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, E effective September 6, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective January 11, 1980 (7:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F repealed effective October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 6, 2006 (33:9 Md. R. 795); amended permanently effective August 28, 2006 (33:17 Md. R. 1436)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective September 5, 1988 (15:18 Md. R. 2148); September 13, 1993 (20:18 Md. R. 1430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective August 24, 1979 (6:17 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 7, 2011 (38:5 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 15, 2012 (39:20 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 18, 2020 (47:10 Md. R. 517); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E adopted effective May 18, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16F amended effective May 18, 2020 (47:10 Md. R. 517)</annotation> </annotations> </chapter> <chapter num="07" heading="Shellfish Sanitation"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish 2023 Revision (US Food and Drug Administration), Section I. Purpose & Definitions and Section II. Model Ordinance except for Chapter IV, Shellstock Growing Areas; and</text> </paragraph> <paragraph num="B."> <text>American Public Health Association, Recommended Procedures for the Examination of Sea Water and Shellfish, 4th Edition, 1970.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Dealer” means a person who is issued a certificate by the Department for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(3)"> <text>“Mechanical refrigeration” means the removal of heat by using a refrigerant subjected to cycles of refrigerating thermodynamics and employing a mechanical compressor.</text> </paragraph> <paragraph num="(4)"> <text>Person-in-Charge.</text> <paragraph num="(a)"> <text>“Person-in charge” means the licensee or other person responsible for the operation of the shellfish plant.</text> </paragraph> <paragraph num="(b)"> <text>“Person-in-charge” includes the dealer as used in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shellfish Aquaculture Harvester Permittee.</text> <paragraph num="(a)"> <text>“Shellfish aquaculture harvester permittee” means a person who is issued a permit by the Department of Natural Resources in accordance with COMAR 08.02.23.04 to harvest shellfish from a submerged land lease or water column lease.</text> </paragraph> <paragraph num="(b)"> <text>“Shellfish aquaculture harvester permittee” includes a person registered to harvest shellfish from the lease cited on a shellfish harvester aquaculture permit.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Temperature control” means the management of the temperature of shellstock by means of ice, mechanical refrigeration, or other approved means necessary to lower and maintain the temperature of the shellstock to 50°F (10°C) or below.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Compliance with Other Chapters."> <paragraph num="A."> <text>The person-in-charge shall ensure that shellfish are processed and the facilities and equipment of a shellfish plant are designed, operated, and maintained in compliance with:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.15.04 and 10.15.10; and</text> </paragraph> <paragraph num="(3)"> <text>The National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding shellfish plants or the processing of shellfish, this chapter takes precedence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licenses and Certifications."> <paragraph num="A."> <text>Except for a licensed harvester delivering the harvester's catch to a certified dealer on the day of harvest, a person may not offer shellfish for sale in-State or interstate unless the person is licensed and certified in accordance with this chapter.</text> </paragraph> <paragraph num="B."> <text>In order to operate a shellfish plant, a person shall obtain a food processing plant license pursuant to the provisions of:</text> <paragraph num="(1)"> <text>Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.15.04; and</text> </paragraph> <paragraph num="(3)"> <text>This chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Shellfish are not purchased, sold, or processed without the:</text> <paragraph num="(a)"> <text>License required by the Health-General Article, §21-305, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Certification required by this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The required food processing plant license and certification are conspicuously posted in the plant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In order to purchase or ship shellfish products in in-State or interstate commerce, a person shall obtain certification pursuant to this chapter.</text> </paragraph> <paragraph num="E."> <text>The Department shall specify on the license and certification issued to a person operating a shellfish plant that the person is approved to operate as a:</text> <paragraph num="(1)"> <text>Shucker-packer (SP);</text> </paragraph> <paragraph num="(2)"> <text>Repacker (RP);</text> </paragraph> <paragraph num="(3)"> <text>Shellstock shipper (SS);</text> </paragraph> <paragraph num="(4)"> <text>Reshipper (RS); or</text> </paragraph> <paragraph num="(5)"> <text>Depuration processor (DP).</text> </paragraph> </paragraph> <paragraph num="F."> <text>The person-in-charge shall ensure that the operations in the plant are limited to the type of shellfish operation specified on the license and certification pursuant to §E of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Bacteriological Standards."> <paragraph num="A."> <text>The person-in-charge:</text> <paragraph num="(1)"> <text>Shall ensure that shellfish are harvested, handled, and processed to meet the bacteriological standards in this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>May not distribute shellfish that do not meet the standards in this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To establish whether compliance is met with the bacteriological standards for shellfish in §C of this regulation, a person shall utilize the isolation, identification, and enumeration in the American Public Health Association Recommended Procedures for the Examination of Sea Water and Shellfish, or other methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results.</text> </paragraph> <paragraph num="C."> <text>The bacteriological standards for shellfish are the following:</text> <paragraph num="(1)"> <text>Standard plate count (SPC) may not exceed 500,000 colony-forming units per gram of shellfish;</text> </paragraph> <paragraph num="(2)"> <text>Except when shellfish are further analyzed for Escherichia coli (E. coli), fecal coliform may not exceed 230 most probable number (MPN) per 100 grams of shellfish; and</text> </paragraph> <paragraph num="(3)"> <text>When shellfish exceed 230 MPN fecal coliform per hundred grams and are further analyzed for E. coli, E. coli may not exceed 330 MPN per 100 grams of shellfish.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall construe numbers of bacteria in excess of the standards set forth in §C of this regulation as rendering the product adulterated, pursuant to Health-General Article, §21-207, Annotated Code of Maryland, and unfit for human consumption.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Vibrio parahaemolyticus Control."> <paragraph num="A."> <text>A dealer and a shellfish aquaculture harvester permittee shall implement control measures as set forth in §B of this regulation to reduce the occurrence of Vibrio parahaemolyticus illness.</text> </paragraph> <paragraph num="B."> <text>Control Measures.</text> <paragraph num="(1)"> <text>From June 1 through September 30, a shellfish aquaculture harvester permittee shall:</text> <paragraph num="(a)"> <text>Protect harvested oysters from direct sun by providing shade over the area where the harvested oysters are stored;</text> </paragraph> <paragraph num="(b)"> <text>Maintain air flow to the area where the harvested oysters are stored;</text> </paragraph> <paragraph num="(c)"> <text>Designate a single site for landing the harvested oysters;</text> </paragraph> <paragraph num="(d)"> <text>Document the harvest start time, which is the time the first oysters are removed from the water, on a harvest trip record or harvest tag; and</text> </paragraph> <paragraph num="(e)"> <text>Provide the harvest time record as set forth in §B(1)(d) of this regulation to a dealer on delivery.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>From June 1 through June 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 11:30 a.m. on the day of harvest.</text> </paragraph> <paragraph num="(3)"> <text>From July 1 through August 31, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 10:30 a.m. on the day of harvest.</text> </paragraph> <paragraph num="(4)"> <text>From September 1 through September 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 12:30 p.m. on the day of harvest.</text> </paragraph> <paragraph num="(5)"> <text>From June 1 through September 30, a dealer may not:</text> <paragraph num="(a)"> <text>Receive oysters harvested from Maryland waters:</text> <paragraph num="(i)"> <text>After the harvest delivery times set forth in §B(2)—(4) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Without a harvest time record as set forth in §B(1)(d) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Sell or ship oysters that have not reached an internal temperature of 50°F (10°C) or below.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>From June 1 through September 30, a dealer shall:</text> <paragraph num="(a)"> <text>Place oysters under temperature control immediately upon delivery from the shellfish aquaculture harvester permittee: and</text> </paragraph> <paragraph num="(b)"> <text>Implement a HACCP plan as defined in COMAR 10.15.04 that recognizes pathogen growth of naturally occurring Vibrio bacteria present from June through September 30 as a significant hazard and includes:</text> <paragraph num="(i)"> <text>Control measures necessary to ensure, document, and verify that the internal temperature of oysters has reached 50°F (10°C) or below within 10 hours or less after being placed under temperature control; and</text> </paragraph> <paragraph num="(ii)"> <text>Corrective action to ensure that oysters that are not cooled to an internal temperature of 50°F (10°C) within 10 hours are not directed to the raw shellfish market.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>To comply with §B(6) of this regulation, a dealer shall ensure that a temperature control mechanism for cooling and storing of oysters:</text> <paragraph num="(a)"> <text>Maintains a temperature of 45°F; and</text> </paragraph> <paragraph num="(b)"> <text>Cools oysters to an internal temperature of 50°F (10°C) in 10 hours or less.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A shellfish aquaculture harvester permittee who is a dealer shall comply with the requirements set forth in §B(1)—(7) of this regulation.</text> </paragraph> <paragraph num="(9)"> <text>The Department may except a shellfish aquaculture harvester permittee who is a dealer from the harvest delivery times set forth in §B(2)—(4) and the receiving time set forth in §B(5)(a)(i) of this regulation if the permittee/dealer:</text> <paragraph num="(a)"> <text>Places harvested oysters under temperature control within 5 hours of harvest start time, which is the time the first oysters are removed from the water; and</text> </paragraph> <paragraph num="(b)"> <text>Implements an HACCP plan as defined in COMAR 10.15.04 that includes the control measures necessary to ensure, document, and verify that the harvested oysters are placed under temperature control within 5 hours of harvest start time.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 21-211, 21-234, 21-235, 21-304, 21-305, 21-321, and 21-346—21-350, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 1, 1967</annotation> <annotation type="History" subtype="Administrative History">Amended effective December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 amended effective May 26, 1976 (3:11 Md. R. 592)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.06 amended as an emergency provision effective August 20, 1985 (12:19 Md. R. 1843); emergency status expired December 18, 1985</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.06 amended effective March 10, 1986 (13:5 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective June 1, 1978 (5:12 Md. R. 964); adopted permanently effective September 22, 1978 (5:19 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new regulations .01—.06 adopted effective November 6, 2006 (33:22 Md. R. 1733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective November 17, 2008 (35:23 Md. R. 2013); October 16, 2009 (36:20 Md. R. 1528); November 14, 2011 (38:23 Md. R. 1421); January 6, 2014 (40:26 Md. R. 2164); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); August 26, 2019 (46:17 Md. R. 726); July 24, 2023 (50:14 Md. R. 593); February 2, 2026 (53:2 Md. R. 61)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 17, 2008 (35:23 Md. R. 2013)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 16, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); adopted permanently effective August 22, 2011 (38:17 Md. R. 1012)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547)</annotation> </annotations> </chapter> <chapter num="08" heading="Farmstead Cheese Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Establishes a farmstead cheese program; and</text> </paragraph> <paragraph num="B."> <text>Sets forth the regulation and enforcement process for:</text> <paragraph num="(1)"> <text>The plan review process for facilities and equipment;</text> </paragraph> <paragraph num="(2)"> <text>The permitting process for the manufacture of cheese made from raw milk;</text> </paragraph> <paragraph num="(3)"> <text>Farmstead cheese:</text> <paragraph num="(a)"> <text>Production;</text> </paragraph> <paragraph num="(b)"> <text>Labeling;</text> </paragraph> <paragraph num="(c)"> <text>Record keeping;</text> </paragraph> <paragraph num="(d)"> <text>Inspections;</text> </paragraph> <paragraph num="(e)"> <text>Packaging;</text> </paragraph> <paragraph num="(f)"> <text>Distribution;</text> </paragraph> <paragraph num="(g)"> <text>Sale;</text> </paragraph> <paragraph num="(h)"> <text>Sampling;</text> </paragraph> <paragraph num="(i)"> <text>Testing; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Assessment of the penalties pursuant to Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Aging of cheese” means the storing and maturing of cheese under controlled conditions of temperature and humidity.</text> </paragraph> <paragraph num="(2)"> <text>“Aging period” means the aging of raw milk cheese for at least 60 calendar days at a temperature of not less than 35°F.</text> </paragraph> <paragraph num="(3)"> <text>“Aging room” means the area where the aging of cheese takes place.</text> </paragraph> <paragraph num="(4)"> <text>“Dairy farm” means a place or premises:</text> <paragraph num="(a)"> <text>Where one or more lactating animals, including cows, goats, sheep, water buffaloes, or other hooved mammals, are kept for milking purposes; and</text> </paragraph> <paragraph num="(b)"> <text>From which the milk is sold or offered for sale.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Departmental inspection area” means the area in which the Department routinely makes inspections under Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Drug residue” means a substance that prevents the growth of bacteria in milk products.</text> </paragraph> <paragraph num="(8)"> <text>“Farmstead cheese” means a cheese made on a dairy farm:</text> <paragraph num="(a)"> <text>Using only the raw milk produced by the herd or flock on the dairy farm; and</text> </paragraph> <paragraph num="(b)"> <text>That meets the definitions and standards of a hard cheese, as set forth in 21 CFR Part 133.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Industry plant sampler” means:</text> <paragraph num="(a)"> <text>An individual responsible for the collection of official samples for regulatory purposes at a plant as outlined in the Grade “A” Pasteurized Milk Ordinance, Appendix N; and</text> </paragraph> <paragraph num="(b)"> <text>An employee of the plant who is evaluated a least once every 2-year period by a sampling surveillance officer or a properly delegated sampling surveillance official.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Milk” means the milk of a cow, goat, or other hooved mammals.</text> </paragraph> <paragraph num="(11)"> <text>“Official laboratory” means a laboratory that is a biological, chemical, or physical laboratory, which is under the direct supervision of the Department.</text> </paragraph> <paragraph num="(12)"> <text>“Officially designated laboratory” means a laboratory that is a:</text> <paragraph num="(a)"> <text>Commercial laboratory authorized to do official work by the Department; or</text> </paragraph> <paragraph num="(b)"> <text>Milk industry laboratory officially designated by the Department for the examination of producer samples of raw milk for drug residue.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Plant” means any place, premise, or establishment where milk or milk products are collected, handled, processed, stored, packaged or otherwise prepared for distribution as a farmstead cheese.</text> </paragraph> <paragraph num="(14)"> <text>“Raw milk” means unpasteurized milk.</text> </paragraph> <paragraph num="(15)"> <text>“Sanitation inspection” means an evaluation of the milk plant and associated processes in accordance with this chapter.</text> </paragraph> <paragraph num="(16)"> <text>“Sanitization” means:</text> <paragraph num="(a)"> <text>The application of any effective method or substance to properly clean surfaces for the destruction of pathogens and other microorganisms, as far as is practicable; and</text> </paragraph> <paragraph num="(b)"> <text>A treatment that:</text> <paragraph num="(i)"> <text>Does not adversely affect the equipment, the milk, milk product, or the health of consumers; and</text> </paragraph> <paragraph num="(ii)"> <text>Is acceptable to the Department.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>21 CFR Part 101, as amended;</text> </paragraph> <paragraph num="B."> <text>21 CFR Part 110, as amended;</text> </paragraph> <paragraph num="C."> <text>21 CFR Part 133, as amended;</text> </paragraph> <paragraph num="D."> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;</text> </paragraph> <paragraph num="E."> <text>United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products”, November 19, 1998.</text> </paragraph> <paragraph num="F."> <text>21 USC §§401—423, as amended;</text> </paragraph> <paragraph num="G."> <text>Food and Drug Administration Compliance Program Guidance Manual, Program 7303.803 (November 9, 2008); and</text> </paragraph> <paragraph num="H."> <text>Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Section 8, Appendix D, Appendix G Section I, Appendix H Section II, and Appendix N only.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Requirements."> <paragraph num="A."> <text>The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth and in compliance with the standards, requirements, and procedures specified in:</text> <paragraph num="(1)"> <text>Health-General Article, Title 21, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and</text> </paragraph> <paragraph num="(3)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535).</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual engaged in an occupation involving farmstead cheese production shall conduct all farmstead cheese production activities as set forth at and in compliance with the standards, requirements, and procedures specified in:</text> <paragraph num="(1)"> <text>Health-General Article, Title 21, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and</text> </paragraph> <paragraph num="(3)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Permitting Requirements."> <paragraph num="A."> <text>Pursuant to Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before the person may be a:</text> <paragraph num="(1)"> <text>Milk producer; or</text> </paragraph> <paragraph num="(2)"> <text>Milk Processor — Farmstead Cheese Producer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may grant or deny a permit based on the criteria, as set forth in this chapter.</text> </paragraph> <paragraph num="C."> <text>To qualify for a permit, an applicant shall:</text> <paragraph num="(1)"> <text>Provide the Department with the plans and specifications set forth in Regulations .14, .15, and .16 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Submit an application to the Department on the forms that the Department provides; and</text> </paragraph> <paragraph num="(3)"> <text>Pay the Department’s required permit fee, as specified in COMAR 10.01.17.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A permit:</text> <paragraph num="(1)"> <text>Expires 1 year from the date of issuance;</text> </paragraph> <paragraph num="(2)"> <text>May be renewed by a producer for a 1-year period upon the payment of the required fee, as specified in COMAR 10.01.17; and</text> </paragraph> <paragraph num="(3)"> <text>May not be transferred from one person to another person or from one farmstead cheese facility to another.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Subject to the availability of sufficient inspection and testing staff, equipment, and other resources, the Department shall issue a permit entitled Milk Processor—Farmstead Cheese Producer:</text> <paragraph num="(1)"> <text>To an applicant in accordance with Health-General Article, §§21-415 and 21-416.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of performing the specific process or processes to the specific milk or milk products as indicated on the plan review and permit applications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanitation Inspection Frequencies and Reports for Plants."> <paragraph num="A."> <text>A farmstead cheese processor shall meet the standards set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department shall conduct sanitation inspections of a plant within the Departmental Inspection Area and any other area designated by the Department:</text> <paragraph num="(1)"> <text>At the start-up of farmstead cheese processing;</text> </paragraph> <paragraph num="(2)"> <text>Once every 6 months; and</text> </paragraph> <paragraph num="(3)"> <text>In response to a complaint received by the Department or a local health department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Once a year a water supply survey shall be conducted to ensure that the requirements in Regulation .14 and .15 of this chapter are met.</text> </paragraph> <paragraph num="D."> <text>Reinspections.</text> <paragraph num="(1)"> <text>If an inspection discloses the existence of a critical or repeat violation of a requirement set forth in this chapter, the Department shall reinspect within 30 days to determine compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If the Department finds on the second inspection a violation of the same requirement of this chapter, the Department shall issue a notice of intent to suspend the permit or a compliance schedule.</text> </paragraph> <paragraph num="(3)"> <text>If the Department finds a violation of the same requirement as specified on the notice of intent to suspend the permit or the compliance schedule as specified in the notice, the Department shall:</text> <paragraph num="(a)"> <text>Suspend the permit in accordance with Regulation .20 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Initiate appropriate court action.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Inspection Reports.</text> <paragraph num="(1)"> <text>The Department shall give one copy of the inspection report to the permit holder or other responsible person or post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection.</text> </paragraph> <paragraph num="(2)"> <text>The permit holder:</text> <paragraph num="(a)"> <text>May not deface the inspection report; and</text> </paragraph> <paragraph num="(b)"> <text>Shall make the inspection report available to the Department upon request.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sanitation Inspection Standards for a Plant."> <text>A plant shall meet the sanitation inspection standards set forth in this regulation:</text> <paragraph num="A."> <text>Floor — Construction.</text> <paragraph num="(1)"> <text>The floor of each room in which product containers, utensils, equipment, milk, or cheese products are handled, processed, packaged, stored, or washed shall be:</text> <paragraph num="(a)"> <text>Constructed of concrete or other equally impervious and easily cleanable material; and</text> </paragraph> <paragraph num="(b)"> <text>Smooth, properly sloped, provided with trapped drains, and kept in good repair.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Floor drains are not required in cold storage rooms used for storing milk and cheese products when the floor is sloped to drain to one or more exits.</text> </paragraph> <paragraph num="(3)"> <text>A storage room for storing dry ingredients, packaged dry ingredients, and packaging materials may have:</text> <paragraph num="(a)"> <text>Floor drains; and</text> </paragraph> <paragraph num="(b)"> <text>Floors constructed of tightly joined wood.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Wall and Ceiling — Construction. The wall and ceiling of each room in which milk or cheese products is handled, processed, packaged, or stored shall:</text> <paragraph num="(1)"> <text>Have a smooth, washable, light colored surface; and</text> </paragraph> <paragraph num="(2)"> <text>Be in good repair.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Door and Window.</text> <paragraph num="(1)"> <text>The plant shall provide effective means to prevent access by insects and rodents.</text> </paragraph> <paragraph num="(2)"> <text>An opening to the outside shall:</text> <paragraph num="(a)"> <text>Have solid doors or glazed windows; and</text> </paragraph> <paragraph num="(b)"> <text>Be closed during weather conditions that may result in particulate matter entering the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Lighting and Ventilation. Each room shall be well lit and well ventilated where:</text> <paragraph num="(1)"> <text>Milk and cheese products are:</text> <paragraph num="(a)"> <text>Handled;</text> </paragraph> <paragraph num="(b)"> <text>Processed;</text> </paragraph> <paragraph num="(c)"> <text>Packaged; or</text> </paragraph> <paragraph num="(d)"> <text>Stored; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Milk containers, utensils, and equipment are washed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Separate Room.</text> <paragraph num="(1)"> <text>There shall be a separate room for:</text> <paragraph num="(a)"> <text>Receiving farmstead cheese;</text> </paragraph> <paragraph num="(b)"> <text>Processing farmstead cheese;</text> </paragraph> <paragraph num="(c)"> <text>Cooling farmstead cheese;</text> </paragraph> <paragraph num="(d)"> <text>Aging farmstead cheese;</text> </paragraph> <paragraph num="(e)"> <text>Packaging farmstead cheese; and</text> </paragraph> <paragraph num="(f)"> <text>Cleaning raw milk cans and containers brought in from the farm.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A room may not open directly into a stable or room used for a domestic purpose where:</text> <paragraph num="(a)"> <text>Milk or a farmstead cheese product is:</text> <paragraph num="(i)"> <text>Received;</text> </paragraph> <paragraph num="(ii)"> <text>Handled;</text> </paragraph> <paragraph num="(iii)"> <text>Processed;</text> </paragraph> <paragraph num="(iv)"> <text>Stored; or</text> </paragraph> <paragraph num="(v)"> <text>Packaged; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Containers, utensils, or equipment are washed or stored.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A room shall be of sufficient size for their intended purposes.</text> </paragraph> <paragraph num="(4)"> <text>Each designated area or room shall be provided for receiving, handling, and storage of a returned packaged or farmstead cheese not suitable for sale.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Toilet Sewage Disposal Facility.</text> <paragraph num="(1)"> <text>Each toilet facility shall conform to the regulations of the local health department.</text> </paragraph> <paragraph num="(2)"> <text>Each toilet facility may not open directly into a room where milk or cheese products are processed.</text> </paragraph> <paragraph num="(3)"> <text>Each toilet facility shall be completely enclosed and have a tight fitting, self-closing door.</text> </paragraph> <paragraph num="(4)"> <text>Each dressing room, toilet room, and fixture shall be:</text> <paragraph num="(a)"> <text>Kept in a clean condition;</text> </paragraph> <paragraph num="(b)"> <text>Kept in good repair;</text> </paragraph> <paragraph num="(c)"> <text>Well ventilated; and</text> </paragraph> <paragraph num="(d)"> <text>Well lit.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Sewage and other liquid waste shall be disposed of in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Water Supply. Water for plant purposes shall be:</text> <paragraph num="(1)"> <text>From a supply properly located, protected, and operated;</text> </paragraph> <paragraph num="(2)"> <text>Easily accessible;</text> </paragraph> <paragraph num="(3)"> <text>Adequate; and</text> </paragraph> <paragraph num="(4)"> <text>Of a safe, sanitary quality.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Handwashing Facility. A hand washing facility shall:</text> <paragraph num="(1)"> <text>Provide:</text> <paragraph num="(a)"> <text>Either:</text> <paragraph num="(i)"> <text>Hot and cold running water; or</text> </paragraph> <paragraph num="(ii)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Soap; and</text> </paragraph> <paragraph num="(c)"> <text>Individual sanitary towels.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be kept in a clean condition and in good repair.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Plant Cleanliness.</text> <paragraph num="(1)"> <text>A room shall be kept clean, neat, and free of evidence of insects and rodents where:</text> <paragraph num="(a)"> <text>Milk and a farmstead cheese product is:</text> <paragraph num="(i)"> <text>Handled;</text> </paragraph> <paragraph num="(ii)"> <text>Processed; or</text> </paragraph> <paragraph num="(iii)"> <text>Stored; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Containers, utensils, or equipment are washed or stored.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Only equipment directly related to processing operations or the handling of containers, utensils, and equipment shall be permitted in a room where:</text> <paragraph num="(a)"> <text>Receiving;</text> </paragraph> <paragraph num="(b)"> <text>Processing;</text> </paragraph> <paragraph num="(c)"> <text>Cooling;</text> </paragraph> <paragraph num="(d)"> <text>Aging;</text> </paragraph> <paragraph num="(e)"> <text>Packaging;</text> </paragraph> <paragraph num="(f)"> <text>Bulk milk is stored; or</text> </paragraph> <paragraph num="(g)"> <text>A cheese product is stored.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Sanitary Piping.</text> <paragraph num="(1)"> <text>The material of a sanitary piping fitting and connection exposed to milk, cheese products, or liquids drawn into milk and cheese products shall be:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Impervious;</text> </paragraph> <paragraph num="(c)"> <text>Corrosion resistant;</text> </paragraph> <paragraph num="(d)"> <text>Nontoxic;</text> </paragraph> <paragraph num="(e)"> <text>Easy cleanable; and</text> </paragraph> <paragraph num="(f)"> <text>An approved surface for food product contact.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All piping shall be in good repair.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Construction and Repair of Containers and Equipment.</text> <paragraph num="(1)"> <text>A multiuse container and equipment that milk and a farmstead cheese product comes into contact with shall be:</text> <paragraph num="(a)"> <text>Constructed of smooth, impervious, corrosion resistant, and nontoxic material;</text> </paragraph> <paragraph num="(b)"> <text>Constructed for ease of cleaning; and</text> </paragraph> <paragraph num="(c)"> <text>Maintained in good repair.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A single service container, closure, gasket, and other article that milk and a farmstead cheese product come in contact with shall be:</text> <paragraph num="(a)"> <text>Nontoxic; and</text> </paragraph> <paragraph num="(b)"> <text>Manufactured, packaged, transported, and handled in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Articles intended for single service use may not be reused.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Clean and Sanitation of Containers and Equipment.</text> <paragraph num="(1)"> <text>The contact surface of a multiuse container, utensil, and equipment used in the farmstead cheese process from receiving through packaging shall, before each use, be effectively cleaned and sanitized.</text> </paragraph> <paragraph num="(2)"> <text>Sanitization:</text> <paragraph num="(a)"> <text>May not adversely affect the equipment, the milk or milk product, or the health of consumers; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be acceptable to the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A cloth used for cheese making shall be cleaned and sanitized at intervals, and in accordance with the Department.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Storage of Cleaned Containers and Equipment. After cleaning, a multiuse milk or farmstead cheese product container, utensil, and equipment shall be:</text> <paragraph num="(1)"> <text>Transported and stored to assure complete drainage; and</text> </paragraph> <paragraph num="(2)"> <text>Protected from contamination before use.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Storage of Single Service Containers, Utensils, and Materials. A wrap, liner, bag, container, gasket, and other single service article in contact with milk and a farmstead cheese product shall be:</text> <paragraph num="(1)"> <text>Purchased and stored in a sanitary tube, wrapping, or carton;</text> </paragraph> <paragraph num="(2)"> <text>Kept in a clean, dry place until used; and</text> </paragraph> <paragraph num="(3)"> <text>Handled in a sanitary manner.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Protection from Contamination.</text> <paragraph num="(1)"> <text>The facility, plant operation, and equipment shall be located and used in a manner to prevent contamination of a milk and farmstead cheese product, ingredient, container, utensil, and equipment.</text> </paragraph> <paragraph num="(2)"> <text>A milk or a farmstead cheese product ingredient shall be discarded if:</text> <paragraph num="(a)"> <text>Spilt;</text> </paragraph> <paragraph num="(b)"> <text>Overflowing;</text> </paragraph> <paragraph num="(c)"> <text>Leaking; or</text> </paragraph> <paragraph num="(d)"> <text>Dropped or has fallen onto an unsanitized contact surface or nonproduct contact surface.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The processing or handling of a product other than milk or a farmstead cheese product in the plant, shall be performed to preclude the contamination of such milk and farmstead cheese products.</text> </paragraph> <paragraph num="(4)"> <text>The storage, handling, and use of a poisonous or toxic material shall be performed to preclude the contamination of:</text> <paragraph num="(a)"> <text>A milk and a farmstead cheese product;</text> </paragraph> <paragraph num="(b)"> <text>An ingredient of milk and a farmstead cheese product; or</text> </paragraph> <paragraph num="(c)"> <text>The product contact surface of a container, utensil, and equipment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="P."> <text>Cross Contamination.</text> <paragraph num="(1)"> <text>During processing, a pipeline and equipment used to contain or conduct milk and a farmstead cheese product shall be effectively separated from each tank or circuit containing cleaning or sanitizing solutions.</text> </paragraph> <paragraph num="(2)"> <text>Separation shall be accomplished by:</text> <paragraph num="(a)"> <text>Physically disconnecting a connection point between each tank or circuit containing a cleaning or sanitizing solution from a pipeline and equipment used to contain or conduct a milk or farmstead cheese product; or</text> </paragraph> <paragraph num="(b)"> <text>A method approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The farmstead cheese processor shall provide a means to prevent contamination of milk and a farmstead cheese product, container, utensil, and equipment from dripping, spillage, and splash from an overhead piping, platform, or mezzanine.</text> </paragraph> <paragraph num="(4)"> <text>A product that may create a public health hazard may not be handled in the plant.</text> </paragraph> <paragraph num="(5)"> <text>Permission to handle a product other than farmstead cheese or to conduct an operation in equipment or a room, other than those designated, shall be provisional and subject to revocation if found objectionable.</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Raw Milk Cooling and Farmstead Cheese Processing.</text> <paragraph num="(1)"> <text>Raw milk shall be maintained at 7ºC (45ºF) or less until processed.</text> </paragraph> <paragraph num="(2)"> <text>Farmstead cheese shall meet the definition of a hard cheese as found in 21 CFR 133.150 which states hard cheese:</text> <paragraph num="(a)"> <text>Contains not more than 39 percent of moisture; and</text> </paragraph> <paragraph num="(b)"> <text>Solids contain not less than 50 percent of milk fat, as determined by the methods prescribed in 21 CFR 133.5(a), (b), and (d).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Farmstead cheese shall be cured at a temperature of not less than 35°F for not less than 60 days.</text> </paragraph> </paragraph> <paragraph num="R."> <text>Personnel Sanitation.</text> <paragraph num="(1)"> <text>An individual shall wash their hands thoroughly before commencing a plant function and as often as may be required to remove soil and contamination.</text> </paragraph> <paragraph num="(2)"> <text>An employee may not resume work after visiting the toilet room without thoroughly washing their hands.</text> </paragraph> <paragraph num="(3)"> <text>An individual shall wear clean outer garments while engaged in the:</text> <paragraph num="(a)"> <text>Handling of raw milk and ingredients;</text> </paragraph> <paragraph num="(b)"> <text>Processing of a farmstead cheese product;</text> </paragraph> <paragraph num="(c)"> <text>Storage of a farmstead cheese product;</text> </paragraph> <paragraph num="(d)"> <text>Transportation of a farmstead cheese product;</text> </paragraph> <paragraph num="(e)"> <text>Packaging of a farmstead cheese product; and</text> </paragraph> <paragraph num="(f)"> <text>Handling of a container, utensil, and equipment.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual, while engaged in the processing of milk or a farmstead cheese product, shall:</text> <paragraph num="(a)"> <text>Wear an adequate hair covering;</text> </paragraph> <paragraph num="(b)"> <text>Abstain from tobacco use;</text> </paragraph> <paragraph num="(c)"> <text>Wear clean and sanitized footwear;</text> </paragraph> <paragraph num="(d)"> <text>Maintain trim and clean fingernails and not wear false fingernails; and</text> </paragraph> <paragraph num="(e)"> <text>Abstain from any activity that may contaminate food.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The farmstead cheese processor shall ensure that education and training is provided to an employee in:</text> <paragraph num="(a)"> <text>Food processing and handling;</text> </paragraph> <paragraph num="(b)"> <text>Personal hygiene; and</text> </paragraph> <paragraph num="(c)"> <text>Plant sanitation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="S."> <text>Vehicles.</text> <paragraph num="(1)"> <text>A vehicle used for the transportation of raw milk and a farmstead cheese product shall be constructed and operated so that the milk and the farmstead cheese product is maintained at 7ºC (45ºF) or less and is protected from contamination.</text> </paragraph> <paragraph num="(2)"> <text>A vehicle used to transport milk and a farmstead cheese product may not be used to transport or contain a substance that may be toxic or harmful to humans.</text> </paragraph> </paragraph> <paragraph num="T."> <text>Surroundings. Plant surroundings shall be kept neat, clean, and free from conditions which:</text> <paragraph num="(1)"> <text>Attract or harbor flies, other insects, or rodents; or</text> </paragraph> <paragraph num="(2)"> <text>Otherwise constitute a nuisance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Examination and Standards of Raw Milk, Farmstead Cheese Finished Products, and Water Supply."> <paragraph num="A."> <text>Raw Milk Sampling and Testing Standards.</text> <paragraph num="(1)"> <text>The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of raw milk used for the manufacture of farmstead cheese;</text> </paragraph> <paragraph num="(2)"> <text>Sampling shall be conducted by an industry plant sampler;</text> </paragraph> <paragraph num="(3)"> <text>The raw milk used for the manufacture of farmstead cheese shall be tested monthly for:</text> <paragraph num="(a)"> <text>Bacteria;</text> </paragraph> <paragraph num="(b)"> <text>Drug residue;</text> </paragraph> <paragraph num="(c)"> <text>Temperature;</text> </paragraph> <paragraph num="(d)"> <text>Odor; and</text> </paragraph> <paragraph num="(e)"> <text>Appearance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Raw Milk Quality Standards.</text> <paragraph num="(1)"> <text>A standard plate count of raw milk for farmstead cheese may not exceed 500,000 per milliliter;</text> </paragraph> <paragraph num="(2)"> <text>Raw milk shall meet the following drug residue standards:</text> <paragraph num="(a)"> <text>Raw milk for farmstead cheese shall be negative for drug residue.</text> </paragraph> <paragraph num="(b)"> <text>Before processing, the industry plant sampler shall collect a representative sample of raw milk used in the manufacture of farmstead cheese; and</text> </paragraph> <paragraph num="(c)"> <text>An official laboratory or officially designated laboratory shall conduct drug residue testing for the presence of drug residue in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Raw milk shall meet the following temperature standards:</text> <paragraph num="(a)"> <text>Raw milk for farmstead cheese shall be cooled to 7°C (45°F) or less within two hours after initial milking;</text> </paragraph> <paragraph num="(b)"> <text>The blend temperature after the first and subsequent milkings may not exceed 10°C (50°F).</text> </paragraph> <paragraph num="(c)"> <text>Raw milk for farmstead cheese shall be cooled to and maintained at a temperature not to exceed 7°C (45°F).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The appearance and odor of raw milk used for farmstead cheese shall be free from:</text> <paragraph num="(a)"> <text>Objectionable feed;</text> </paragraph> <paragraph num="(b)"> <text>Off odors; and</text> </paragraph> <paragraph num="(c)"> <text>Abnormalities.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In accordance with the Department, an official laboratory or officially designated laboratory shall test a composite milk sample and shall rate it “acceptable for use” if there is no actionable residue for:</text> <paragraph num="(a)"> <text>Radionuclides;</text> </paragraph> <paragraph num="(b)"> <text>Pesticides; and</text> </paragraph> <paragraph num="(c)"> <text>Herbicides.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Added water shall be tested on an individual producer’s milk in accordance with the Department’s official laboratory or officially designated laboratory and rated “acceptable for use” if the test result is -0.540°H or less.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Farmstead Cheese Finished Product Sampling.</text> <paragraph num="(1)"> <text>The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of a finished farmstead cheese product;</text> </paragraph> <paragraph num="(2)"> <text>Sampling shall be conducted by an industry plant sampler;</text> </paragraph> <paragraph num="(3)"> <text>The initial three finished products of each farmstead cheese shall be tested for:</text> <paragraph num="(a)"> <text>Salmonella;</text> </paragraph> <paragraph num="(b)"> <text>Escherichia coli (E. coli);</text> </paragraph> <paragraph num="(c)"> <text>Listeria monocytogenes;</text> </paragraph> <paragraph num="(d)"> <text>Staphylococcus aureus;</text> </paragraph> <paragraph num="(e)"> <text>Enterohemorrhagic E. coli (0157:H7); and</text> </paragraph> <paragraph num="(f)"> <text>Percent moisture.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The finished product of each farmstead cheese shall be tested annually and is in accordance with §C(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Farmstead Cheese Finished Product Quality Standards. The farmstead cheese finished product:</text> <paragraph num="(1)"> <text>Shall test negative for Salmonella, Enterohemorrhagic E. coli (0157:H7), and Listeria monocytogenes;</text> </paragraph> <paragraph num="(2)"> <text>Shall test less than 10 cfu/gram for E. coli and Staphylococcus aureus; and</text> </paragraph> <paragraph num="(3)"> <text>May not be greater than 39 percent moisture.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Farmstead Cheese Processing Standards. The farmstead cheese:</text> <paragraph num="(1)"> <text>Finished product shall be aged at least 60 calendar days before offering for sale;</text> </paragraph> <paragraph num="(2)"> <text>Shall be aged or cured at a temperature of not less than 35°F; and</text> </paragraph> <paragraph num="(3)"> <text>Finished product may not contain more than 39 percent moisture at the end of the aging period.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The farmstead cheese processor shall ensure that the result of all tested farmstead cheese finished products are submitted and approved by the Department before further processing or sale of the farmstead cheese.</text> </paragraph> <paragraph num="G."> <text>The Department may request that the farmstead cheese processor have the farmstead cheese finished product tested, as needed, as set forth in the United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products,” to ensure compliance with this regulation.</text> </paragraph> <paragraph num="H."> <text>Water Samples.</text> <paragraph num="(1)"> <text>Samples for bacteriological testing of the plant water supply and, if applicable, any other water used for cooling and processing shall be collected:</text> <paragraph num="(a)"> <text>Upon the initial approval of the physical structure;</text> </paragraph> <paragraph num="(b)"> <text>Every 6 months thereafter; and</text> </paragraph> <paragraph num="(c)"> <text>When any repair or alteration to the water supply system has been made.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Plant water for testing shall be obtained from a potable water supply system that complies with Regulation .15A of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Samples shall be taken by the Department and examined by an official laboratory.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Record Keeping Required.</text> <paragraph num="(1)"> <text>Current written step by step standard operating procedures are required for:</text> <paragraph num="(a)"> <text>Product trace back;</text> </paragraph> <paragraph num="(b)"> <text>Product recalls;</text> </paragraph> <paragraph num="(c)"> <text>Drug residue testing;</text> </paragraph> <paragraph num="(d)"> <text>Cleaning of the equipment and facility;</text> </paragraph> <paragraph num="(e)"> <text>Sanitizing equipment and product contact surfaces;</text> </paragraph> <paragraph num="(f)"> <text>Receiving, processing, aging, storage, and packaging of each type of farmstead cheese produced;</text> </paragraph> <paragraph num="(g)"> <text>Pest control and preventative maintenance; and</text> </paragraph> <paragraph num="(h)"> <text>Employee training including personal hygiene practices;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Processing records shall include the:</text> <paragraph num="(a)"> <text>Product being manufactured;</text> </paragraph> <paragraph num="(b)"> <text>Drug residue testing as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix N;</text> </paragraph> <paragraph num="(c)"> <text>Date and result of the raw milk testing;</text> </paragraph> <paragraph num="(d)"> <text>Date and result of the finished farmstead cheese product tested;</text> </paragraph> <paragraph num="(e)"> <text>The pH of each batch after inoculation at 5 hours, 24 hours, and the end of aging; and</text> </paragraph> <paragraph num="(f)"> <text>Raw ingredient:</text> <paragraph num="(i)"> <text>Origin;</text> </paragraph> <paragraph num="(ii)"> <text>Storage;</text> </paragraph> <paragraph num="(iii)"> <text>Transportation; and</text> </paragraph> <paragraph num="(iv)"> <text>Other information required by the Department; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Temperature, as set forth in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For each batch of farmstead cheese produced, a make record shall be maintained and include:</text> <paragraph num="(a)"> <text>The name of the product being produced;</text> </paragraph> <paragraph num="(b)"> <text>The temperature of the milk being used;</text> </paragraph> <paragraph num="(c)"> <text>A unique identifier assigned at the start of the production of that batch of cheese shall be:</text> <paragraph num="(i)"> <text>Used to track each batch of cheese through the production process; and</text> </paragraph> <paragraph num="(ii)"> <text>Included on the product label;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The amount of product being produced;</text> </paragraph> <paragraph num="(e)"> <text>The name and amount of each ingredient added;</text> </paragraph> <paragraph num="(f)"> <text>The cook temperature;</text> </paragraph> <paragraph num="(g)"> <text>The pH of the product after inoculation at 5 hours, 24 hours, and the end of aging; and</text> </paragraph> <paragraph num="(h)"> <text>The production date for the product which is the date the batch entered the aging room to start the aging process; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Each record shall be available to the Department for review during each inspection.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Enforcement Actions."> <paragraph num="A."> <text>Raw Milk Enforcement.</text> <paragraph num="(1)"> <text>When two of the last four consecutive bacterial count or cooling temperatures, taken on separate days, exceed the limit for raw milk, as set forth in this chapter, the Department shall:</text> <paragraph num="(a)"> <text>Send to the permit holder a written notice of intent to suspend the permit which shall remain in effect as long as two of the last four consecutive samples exceed the limit of the standard; and</text> </paragraph> <paragraph num="(b)"> <text>Take an additional sample within 21 days of the written notice of intent to suspend, but not before 3 days have elapsed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the standard set forth in Regulation .08 of this chapter is violated three of the last five consecutive bacterial counts or cooling temperature tests the Department shall immediately suspend the permit in accordance with this section, Regulation .20 of this chapter, and Health-General Article, §21-418, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall conduct an investigation and take enforcement action in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N, when a drug test is positive.</text> </paragraph> <paragraph num="(4)"> <text>When an odor and appearance evaluation results in rejection of milk:</text> <paragraph num="(a)"> <text>The Department shall conduct an investigation to determine the reason for the rejection; and</text> </paragraph> <paragraph num="(b)"> <text>A person may not offer the rejected milk for sale.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When a pesticide, herbicide, or radionuclide residue test is positive:</text> <paragraph num="(a)"> <text>The Department shall conduct an investigation to determine the cause and the cause shall be corrected;</text> </paragraph> <paragraph num="(b)"> <text>An additional sample shall be taken and tested for the pesticide, herbicide, or radionuclide, and no milk shall be used for processing or offered for sale until it is shown by a subsequent sample to be free of the positive residue; and</text> </paragraph> <paragraph num="(c)"> <text>The Department may suspend a permit based on the presence of pesticide, herbicide, or radionuclide residue.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Farmstead Cheese Finished Product Enforcement.</text> <paragraph num="(1)"> <text>When the pathogen testing result exceeds the limits set forth in Regulation .08 of this chapter, the cheese in violation may not be offered for sale, and the:</text> <paragraph num="(a)"> <text>Department shall conduct an investigation to determine the cause; and</text> </paragraph> <paragraph num="(b)"> <text>Cause shall be corrected prior to resumption of processing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A person may not offer for sale a farmstead cheese product if the processing requirement is in violation of this chapter at the end of the aging period:</text> <paragraph num="(a)"> <text>Days of aging;</text> </paragraph> <paragraph num="(b)"> <text>Temperature during aging; or</text> </paragraph> <paragraph num="(c)"> <text>Percent moisture.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Cheese may be detained and further pathogen testing may be required to show compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement of Permits.</text> <paragraph num="(1)"> <text>To reinstate a permit that is suspended for either a bacteria count or cooling violation the permit holder shall:</text> <paragraph num="(a)"> <text>Submit a written application for the reinstatement of the permit;</text> </paragraph> <paragraph num="(b)"> <text>Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected;</text> </paragraph> <paragraph num="(c)"> <text>Accept a temporary permit if it has determined that the facility is in compliance; and</text> </paragraph> <paragraph num="(d)"> <text>Complete an accelerated sampling program at the rate of no more than two samples per week on separate days within a 3-week period to confirm that the violation has been corrected.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall fully reinstate the permit upon compliance with the appropriate bacteria and temperature standard as determined in accordance with Regulation .08 of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>To reinstate a suspended permit for violations other than bacteriological, drug residue test, or cooling temperature standards, the permit holder shall:</text> <paragraph num="(a)"> <text>Notify the Department that the violation has been corrected; and</text> </paragraph> <paragraph num="(b)"> <text>Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of the Grade “A” Pasteurized Milk Ordinance, Appendix N, incorporated by reference in Regulation .03 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Improper Handling of Milk Products."> <paragraph num="A."> <text>Pursuant to Health-General Article, §21-428, Annotated Code of Maryland, the Department shall impound milk or a milk product intended for human consumption due to improper handling.</text> </paragraph> <paragraph num="B."> <text>The Department may:</text> <paragraph num="(1)"> <text>Issue an order to make the milk or milk product unusable for consumption before disposing of the milk or milk product; and</text> </paragraph> <paragraph num="(2)"> <text>Impose a civil monetary penalty, as set forth in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall determine the amount of the civil monetary penalty by multiplying the volume of the milk listed on the shipping documents by the current milk price of the applicable market, as set by the Federal Milk Market Administrator on the date of the impounding.</text> </paragraph> <paragraph num="D."> <text>A person subject to an impoundment order may seek legal recourse, as set forth in Health-General Article §21-428, Annotated Code of Maryland, by:</text> <paragraph num="(1)"> <text>Appealing a civil penalty; or</text> </paragraph> <paragraph num="(2)"> <text>Bringing an action for damages.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Labeling of Farmstead Cheese."> <text>A farmstead cheese processor shall:</text> <paragraph num="A."> <text>Ensure all labels for a farmstead cheese product conform to the standards and requirements established by:</text> <paragraph num="(1)"> <text>The Federal Food, Drug, and Cosmetic Act, 21 USC, §§341—350f;</text> </paragraph> <paragraph num="(2)"> <text>The Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(3)"> <text>21 CFR Parts 101 and 133; and</text> </paragraph> <paragraph num="(4)"> <text>Health-General Article, §21-424, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Conspicuously mark each package containing farmstead cheese with the:</text> <paragraph num="(1)"> <text>Name of the product;</text> </paragraph> <paragraph num="(2)"> <text>Name of the manufacturer that made the farmstead cheese;</text> </paragraph> <paragraph num="(3)"> <text>Address of the manufacturer if:</text> <paragraph num="(a)"> <text>Listed in the local phone book, the address may consist of the city and state; or</text> </paragraph> <paragraph num="(b)"> <text>Not listed in the local phone book, the street address shall be included;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Plant license number;</text> </paragraph> <paragraph num="(5)"> <text>Each ingredient in order of predominance;</text> </paragraph> <paragraph num="(6)"> <text>Net weight of the product in English and metric units;</text> </paragraph> <paragraph num="(7)"> <text>Batch identification of the product;</text> </paragraph> <paragraph num="(8)"> <text>Required nutritional information;</text> </paragraph> <paragraph num="(9)"> <text>Statement:</text> <paragraph num="(a)"> <text>“Cured or aged for 60 days at a temperature not less than 35° F;” or</text> </paragraph> <paragraph num="(b)"> <text>A variation of this phrase that conveys the fact that the product has been aged at least 60 days; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Statement that the milk was not pasteurized, using terms such as “raw milk” or “not pasteurized.”</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Sale of Raw Milk."> <text>Pursuant to Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Animal Health."> <text>All raw milk for farmstead cheese shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8, incorporated by reference in Regulation .03 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Plant Construction and Plan Submission."> <text>Pursuant to Health-General Article, §§21-410, 21-411, and 21-413 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:</text> <paragraph num="A."> <text>A plan and specification before:</text> <paragraph num="(1)"> <text>A plant is constructed, reconstructed, or extensively altered;</text> </paragraph> <paragraph num="(2)"> <text>An existing building or structure is converted or remodeled for use as a plant;</text> </paragraph> <paragraph num="(3)"> <text>A plant process is added, replaced, relocated, or modified; or</text> </paragraph> <paragraph num="(4)"> <text>A clean-in-place (CIP), other washing system, or part of a CIP is added, modified, or replaced;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;</text> </paragraph> <paragraph num="C."> <text>Contact information for the facility, including:</text> <paragraph num="(1)"> <text>The full name, title, and telephone number of each applicant;</text> </paragraph> <paragraph num="(2)"> <text>The name of the plant;</text> </paragraph> <paragraph num="(3)"> <text>The mailing address;</text> </paragraph> <paragraph num="(4)"> <text>The location; and</text> </paragraph> <paragraph num="(5)"> <text>Directions to the site;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A narrative describing the scope and purpose of the project, including a projected timeline from start to completion;</text> </paragraph> <paragraph num="E."> <text>An estimate of the finished product output per day;</text> </paragraph> <paragraph num="F."> <text>A sample product label for each product;</text> </paragraph> <paragraph num="G."> <text>A list of the:</text> <paragraph num="(1)"> <text>Type of raw milk cheese to be processed and sold;</text> </paragraph> <paragraph num="(2)"> <text>Each raw ingredient and the ingredient source; and</text> </paragraph> <paragraph num="(3)"> <text>Single service container source;</text> </paragraph> </paragraph> <paragraph num="H."> <text>A scale drawing showing the layout and arrangement of an area within and around the plant, including the:</text> <paragraph num="(1)"> <text>Processing area;</text> </paragraph> <paragraph num="(2)"> <text>Chemical storage;</text> </paragraph> <paragraph num="(3)"> <text>Dry storage;</text> </paragraph> <paragraph num="(4)"> <text>Ingredient and product storage;</text> </paragraph> <paragraph num="(5)"> <text>Receiving area;</text> </paragraph> <paragraph num="(6)"> <text>Load out area;</text> </paragraph> <paragraph num="(7)"> <text>Laboratory space;</text> </paragraph> <paragraph num="(8)"> <text>Office;</text> </paragraph> <paragraph num="(9)"> <text>Restroom facility;</text> </paragraph> <paragraph num="(10)"> <text>Locker or similar storage facility for the storage of personal items; and</text> </paragraph> <paragraph num="(11)"> <text>Separate area for employees to eat and drink beverages;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A scale drawing showing the location of all equipment, including the:</text> <paragraph num="(1)"> <text>Milk processing equipment;</text> </paragraph> <paragraph num="(2)"> <text>Milk tank and silo;</text> </paragraph> <paragraph num="(3)"> <text>CIP system;</text> </paragraph> <paragraph num="(4)"> <text>Glycol water tank;</text> </paragraph> <paragraph num="(5)"> <text>Recirculating cooling water tank;</text> </paragraph> <paragraph num="(6)"> <text>Boiler; and</text> </paragraph> <paragraph num="(7)"> <text>Boiler makeup tank;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A scale drawing showing the location of plumbing and each plumbing fixture, including the:</text> <paragraph num="(1)"> <text>Water line;</text> </paragraph> <paragraph num="(2)"> <text>Sewer line;</text> </paragraph> <paragraph num="(3)"> <text>Hand sink;</text> </paragraph> <paragraph num="(4)"> <text>Toilet;</text> </paragraph> <paragraph num="(5)"> <text>Utility sink;</text> </paragraph> <paragraph num="(6)"> <text>Utensil washing sink;</text> </paragraph> <paragraph num="(7)"> <text>Floor drain;</text> </paragraph> <paragraph num="(8)"> <text>Floor sink;</text> </paragraph> <paragraph num="(9)"> <text>Hose station; and</text> </paragraph> <paragraph num="(10)"> <text>Back flow prevention device;</text> </paragraph> </paragraph> <paragraph num="K."> <text>A legend for each drawing;</text> </paragraph> <paragraph num="L."> <text>Specifications for:</text> <paragraph num="(1)"> <text>Ventilation, including, but not limited to, the type and location of:</text> <paragraph num="(a)"> <text>An air filter;</text> </paragraph> <paragraph num="(b)"> <text>An air pump; and</text> </paragraph> <paragraph num="(c)"> <text>A compressor; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Construction material for the building and interior finish;</text> </paragraph> </paragraph> <paragraph num="M."> <text>A list and description of boiler, glycol, and recirculating water additive and water treatment;</text> </paragraph> <paragraph num="N."> <text>A description of the:</text> <paragraph num="(1)"> <text>Type of disposal for wastewater and sewage;</text> </paragraph> <paragraph num="(2)"> <text>Source and system for the facility’s potable water supply;</text> </paragraph> <paragraph num="(3)"> <text>Lighting fixture and placement; and</text> </paragraph> <paragraph num="(4)"> <text>Recirculating cooling system;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Each specification sheet, including manufacturer and model number of the plant equipment;</text> </paragraph> <paragraph num="P."> <text>A document that lists the flow for a products through the plant identifying each functional piece of equipment and each process used in processing and packaging;</text> </paragraph> <paragraph num="Q."> <text>A CIP flow diagram from the makeup tanks through all equipment;</text> </paragraph> <paragraph num="R."> <text>Information and drawings on how separation from product lines will be accomplished, if applicable;</text> </paragraph> <paragraph num="S."> <text>Written step by step standard operating procedures for:</text> <paragraph num="(1)"> <text>Receiving, processing, aging, storing, and packaging of each type of farmstead cheese product;</text> </paragraph> <paragraph num="(2)"> <text>Drug residue testing;</text> </paragraph> <paragraph num="(3)"> <text>Cleaning and sanitization for all equipment;</text> </paragraph> <paragraph num="(4)"> <text>Cleaning and sanitization for the facility;</text> </paragraph> <paragraph num="(5)"> <text>Product trace back, inclusive of production/make sheet; and</text> </paragraph> <paragraph num="(6)"> <text>Product recall;</text> </paragraph> </paragraph> <paragraph num="T."> <text>Pest and mite control program;</text> </paragraph> <paragraph num="U."> <text>A specification and standard operating procedure for how wood shelving used in the aging of cheese will be:</text> <paragraph num="(1)"> <text>Designed;</text> </paragraph> <paragraph num="(2)"> <text>Installed;</text> </paragraph> <paragraph num="(3)"> <text>Used;</text> </paragraph> <paragraph num="(4)"> <text>Cleaned;</text> </paragraph> <paragraph num="(5)"> <text>Sanitized;</text> </paragraph> <paragraph num="(6)"> <text>Maintained; and</text> </paragraph> <paragraph num="(7)"> <text>Inspected by the farmstead cheese processor; and</text> </paragraph> </paragraph> <paragraph num="V."> <text>Employee training and personal hygiene practices.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Physical Plant Requirements for Plants."> <paragraph num="A."> <text>Water used at a farmstead cheese facility shall:</text> <paragraph num="(1)"> <text>Be obtained from a potable water supply system that complies with:</text> <paragraph num="(a)"> <text>Environment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 26.04.04; and</text> </paragraph> <paragraph num="(c)"> <text>The Grade “A” Pasteurized Milk Ordinance, Appendix D, incorporated by reference in Regulation .03 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be installed in a manner that prevents backflow or back siphoning;</text> </paragraph> <paragraph num="(3)"> <text>Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system;</text> </paragraph> <paragraph num="(4)"> <text>Provide hot and cold running water in an area where milk processing equipment is washed; and</text> </paragraph> <paragraph num="(5)"> <text>Have sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the washing system;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hand sinks shall have:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Hot and cold running water; or</text> </paragraph> <paragraph num="(b)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supply of hand cleaning soap or detergent; and</text> </paragraph> <paragraph num="(3)"> <text>A sanitary means of drying hands, such as individual towels or a hand drying device;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations;</text> </paragraph> <paragraph num="D."> <text>Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and</text> </paragraph> <paragraph num="E."> <text>Electrical systems at the facility shall:</text> <paragraph num="(1)"> <text>Comply with State and local electrical laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Provide adequate lighting sources that furnish at least 30 foot candles of light in all working areas and rooms where:</text> <paragraph num="(a)"> <text>Milk or a milk product is handled, processed, packaged, or stored; or</text> </paragraph> <paragraph num="(b)"> <text>A container, utensil, and equipment are washed; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide adequate lighting sources that furnish at least five foot candles of light in dry storage and cold storage rooms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Plan Review and Approval Process."> <paragraph num="A."> <text>An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .14 and .15 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .14 and .15 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the applicant:</text> <paragraph num="(a)"> <text>That the plan has been received;</text> </paragraph> <paragraph num="(b)"> <text>If additional information is required to complete the plan review;</text> </paragraph> <paragraph num="(c)"> <text>Whether the plan is approved or denied; and</text> </paragraph> <paragraph num="(d)"> <text>Of the appeal process, if the plan is denied.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Personnel Health."> <text>No individual affected with any disease capable of being transmitted to others through the contamination of food shall work at a plant in any capacity which brings them into direct contact with:</text> <paragraph num="A."> <text>Raw milk, a farmstead cheese product, and a food ingredient; or</text> </paragraph> <paragraph num="B."> <text>Associated raw milk and a food product contact surface.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Procedure When Infection or High Risk of Infection is Suspected or Discovered."> <text>In accordance with Health-General Article, §§18-102, 21-253, 21-254, and 21-435, Annotated Code of Maryland, when an individual working at a plant has a communicable disease or is a carrier of a communicable disease the Department:</text> <paragraph num="A."> <text>Shall immediately exclude the:</text> <paragraph num="(1)"> <text>Individual from handling milk, milk products, milk containers, and milk equipment; and</text> </paragraph> <paragraph num="(2)"> <text>Milk supply that is handled by the infected individual from distribution and use; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>May require medical and biological examination of the individual and the individual’s bodily discharges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Confidentiality."> <text>The Department shall maintain confidentiality of records submitted by a person in accordance with §4-335 of the General Provisions Article, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Suspension and Revocation of Permits."> <paragraph num="A."> <text>When a farmstead cheese processor is found in violation of this chapter, the Department may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided in this regulation, before suspending a permit, the Department shall give to the farmstead cheese processor notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department may suspend a permit if the farmstead cheese processor fails or neglects to correct a violation within the specified time period.</text> </paragraph> <paragraph num="D."> <text>If a permit has been suspended more than once, the Department may revoke the permit.</text> </paragraph> <paragraph num="E."> <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:</text> <paragraph num="(1)"> <text>Department shall:</text> <paragraph num="(a)"> <text>Summarily suspend the permit;</text> </paragraph> <paragraph num="(b)"> <text>Order the farmstead cheese processor to cease operation immediately; and</text> </paragraph> <paragraph num="(c)"> <text>Promptly provide the farmstead cheese processor with:</text> <paragraph num="(i)"> <text>A written notice of the suspension of the permit;</text> </paragraph> <paragraph num="(ii)"> <text>The reasons for the suspension; and</text> </paragraph> <paragraph num="(iii)"> <text>An opportunity to be heard; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The farmstead cheese processor shall immediately cease operation upon the receipt of the summary suspension order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Appeals Process."> <text>In accordance with the Administrative Procedures Act and Health-General Article, §21-419 the Department shall ensure that an opportunity for a hearing is provided to a farmstead cheese processor whose plan review or permit has been:</text> <paragraph num="A."> <text>Denied;</text> </paragraph> <paragraph num="B."> <text>Suspended; or</text> </paragraph> <paragraph num="C."> <text>Revoked.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§21-211, 21-234, 21-406, 21-416.1, 21-417, 21-418, 21-419,21-428, 21-434, 21-252—21-256, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 4, 2009 (36:9 Md. R. 651)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 28, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 28, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 407)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective February 27, 2017 (44:4 Md. R. 254); May 18, 2020 (47:10 Md. R. 517)</annotation> </annotations> </chapter> <chapter num="09" heading="Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>In accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, this chapter:</text> <paragraph num="(1)"> <text>Governs permits for the sale of milk for manufacturing processes;</text> </paragraph> <paragraph num="(2)"> <text>Describes the requirement for a permit for the sale of milk for manufacturing purposes; and</text> </paragraph> <paragraph num="(3)"> <text>Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter also sets forth:</text> <paragraph num="(1)"> <text>Standards for milk manufacturing;</text> </paragraph> <paragraph num="(2)"> <text>The plan review process for manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products;</text> </paragraph> <paragraph num="(3)"> <text>The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of manufactured grade milk and milk products;</text> </paragraph> <paragraph num="(4)"> <text>Penalties pursuant to Health-General Article, §§21-211, 21-252—21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(5)"> <text>Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“3-A Sanitary Standards” means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the:</text> <paragraph num="(a)"> <text>American Dairy Products Institute;</text> </paragraph> <paragraph num="(b)"> <text>International Dairy Foods Association;</text> </paragraph> <paragraph num="(c)"> <text>Food Processing Suppliers Association; and</text> </paragraph> <paragraph num="(d)"> <text>International Association for Food Protection.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Agistment agreement” means the sale of shares or interest in a:</text> <paragraph num="(a)"> <text>Cow, goat, or other lactating hooved mammal; or</text> </paragraph> <paragraph num="(b)"> <text>Herd of cows, goats, or other lactating hooved mammals.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Approved” means meeting the criteria set forth in this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.</text> </paragraph> <paragraph num="(5)"> <text>“Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor.</text> </paragraph> <paragraph num="(6)"> <text>“Bulk milk hauler/sampler” means an individual who:</text> <paragraph num="(a)"> <text>Collects official samples;</text> </paragraph> <paragraph num="(b)"> <text>Transports raw milk from a farm, or raw milk products to or from a:</text> <paragraph num="(i)"> <text>Milk plant;</text> </paragraph> <paragraph num="(ii)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(iii)"> <text>Transfer station;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Possesses a permit from any state to sample milk or raw milk products; and</text> </paragraph> <paragraph num="(d)"> <text>If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat.</text> </paragraph> <paragraph num="(8)"> <text>“Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section.</text> </paragraph> <paragraph num="(9)"> <text>“Cheese” means the fresh or matured product that:</text> <paragraph num="(a)"> <text>Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the standards of identity in 21 CFR Part 133.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.</text> </paragraph> <paragraph num="(11)"> <text>“Dairy farm” means a place where at least one cow, goat, or other hooved mammal is kept, and from which the milk from these animals is sold or offered for sale.</text> </paragraph> <paragraph num="(12)"> <text>“Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="(13)"> <text>“Department” means the Maryland Department of Health or its designee.</text> </paragraph> <paragraph num="(14)"> <text>“Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary.</text> </paragraph> <paragraph num="(15)"> <text>“Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred.</text> </paragraph> <paragraph num="(16)"> <text>“Distributor” means a person who offers for sale a manufactured grade milk product.</text> </paragraph> <paragraph num="(17)"> <text>“Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments.</text> </paragraph> <paragraph num="(18)"> <text>“Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments.</text> </paragraph> <paragraph num="(19)"> <text>“Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station.</text> </paragraph> <paragraph num="(20)"> <text>“Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes.</text> </paragraph> <paragraph num="(21)"> <text>“Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter.</text> </paragraph> <paragraph num="(22)"> <text>“Manufactured grade milk product” means:</text> <paragraph num="(a)"> <text>Butter;</text> </paragraph> <paragraph num="(b)"> <text>Cheese, natural or processed;</text> </paragraph> <paragraph num="(c)"> <text>Condensed skim milk, plain or sweetened;</text> </paragraph> <paragraph num="(d)"> <text>Condensed whole milk;</text> </paragraph> <paragraph num="(e)"> <text>Cream;</text> </paragraph> <paragraph num="(f)"> <text>Dry buttermilk;</text> </paragraph> <paragraph num="(g)"> <text>Dry whey;</text> </paragraph> <paragraph num="(h)"> <text>Dry whole milk;</text> </paragraph> <paragraph num="(i)"> <text>Evaporated milk, whole or skim;</text> </paragraph> <paragraph num="(j)"> <text>Nonfat dry milk;</text> </paragraph> <paragraph num="(k)"> <text>Quark; or</text> </paragraph> <paragraph num="(l)"> <text>Any other product made with manufactured grade milk that is regulated by the Department.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthy hooved mammals.</text> </paragraph> <paragraph num="(24)"> <text>“Milk facility” means a:</text> <paragraph num="(a)"> <text>Distribution station;</text> </paragraph> <paragraph num="(b)"> <text>Milk plant;</text> </paragraph> <paragraph num="(c)"> <text>Milk processor;</text> </paragraph> <paragraph num="(d)"> <text>Milk tank truck cleaning facility;</text> </paragraph> <paragraph num="(e)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(f)"> <text>Transfer station.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product.</text> </paragraph> <paragraph num="(26)"> <text>“Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.</text> </paragraph> <paragraph num="(27)"> <text>Milk Plant.</text> <paragraph num="(a)"> <text>“Milk plant” means a place where milk products are:</text> <paragraph num="(i)"> <text>Received and stored;</text> </paragraph> <paragraph num="(ii)"> <text>Processed;</text> </paragraph> <paragraph num="(iii)"> <text>Pasteurized;</text> </paragraph> <paragraph num="(iv)"> <text>Packaged; or</text> </paragraph> <paragraph num="(v)"> <text>Prepared for distribution.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Milk plant” does not include a place where milk products are sold at retail only.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Milk processor” means a person who owns, operates, or controls a milk plant.</text> </paragraph> <paragraph num="(29)"> <text>“Milk producer” means a person who:</text> <paragraph num="(a)"> <text>Operates a dairy farm; and</text> </paragraph> <paragraph num="(b)"> <text>Provides, sells, or offers milk for sale to a:</text> <paragraph num="(i)"> <text>Milk plant;</text> </paragraph> <paragraph num="(ii)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(iii)"> <text>Transfer station.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk.</text> </paragraph> <paragraph num="(31)"> <text>“Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.</text> </paragraph> <paragraph num="(32)"> <text>“Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized.</text> </paragraph> <paragraph num="(33)"> <text>“Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk.</text> </paragraph> <paragraph num="(34)"> <text>“Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant.</text> </paragraph> <paragraph num="(35)"> <text>“National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program.</text> </paragraph> <paragraph num="(36)"> <text>Nonfat.</text> <paragraph num="(a)"> <text>“Nonfat” means a product contains less than 0.5 percent fat.</text> </paragraph> <paragraph num="(b)"> <text>“Nonfat” has the same meaning as skim or fat free.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.</text> </paragraph> <paragraph num="(38)"> <text>“Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of:</text> <paragraph num="(a)"> <text>Producer samples of Grade “A” raw milk for pasteurization; or</text> </paragraph> <paragraph num="(b)"> <text>Comingled milk tank truck samples of Grade “A” raw milk.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.</text> </paragraph> <paragraph num="(40)"> <text>“Pasteurization” means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by:</text> <paragraph num="(a)"> <text>Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:</text> <paragraph num="(i)"> <text>63°C (145°F) for 30 minutes;</text> </paragraph> <paragraph num="(ii)"> <text>72°C (161°F) for 15 seconds;</text> </paragraph> <paragraph num="(iii)"> <text>89°C (191°F) for 1 second;</text> </paragraph> <paragraph num="(iv)"> <text>90°C (194°F) for 0.5 seconds;</text> </paragraph> <paragraph num="(v)"> <text>94°C (201°F) for 0.1 seconds;</text> </paragraph> <paragraph num="(vi)"> <text>96°C (204°F) for 0.05 seconds; or</text> </paragraph> <paragraph num="(vii)"> <text>100°C (212°F) for 0.01 seconds;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:</text> <paragraph num="(i)"> <text>66°C (150°F) for 30 minutes;</text> </paragraph> <paragraph num="(ii)"> <text>75°C (166°F) for 15 seconds; or</text> </paragraph> <paragraph num="(iii)"> <text>The temperatures and times listed in §B(34)(a)(iii)—(vii) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or</text> </paragraph> <paragraph num="(d)"> <text>Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3).</text> </paragraph> </paragraph> <paragraph num="(41)"> <text>“Permit” means an official document with a manufactured grade classification issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit.</text> </paragraph> <paragraph num="(42)"> <text>“Permittee” means a person who holds a permit as defined in this chapter.</text> </paragraph> <paragraph num="(43)"> <text>Person.</text> <paragraph num="(a)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(b)"> <text>“Person” includes:</text> <paragraph num="(i)"> <text>An operator of a facility that is owned by a State or local unit of government; or</text> </paragraph> <paragraph num="(ii)"> <text>A State or local unit of government if the State or local unit of government is the operator of the facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(44)"> <text>“Raw milk” means unpasteurized milk, which includes:</text> <paragraph num="(a)"> <text>Heat treated nonfat skim milk;</text> </paragraph> <paragraph num="(b)"> <text>Heat treated reduced fat milk;</text> </paragraph> <paragraph num="(c)"> <text>Heat treated lowfat milk; and</text> </paragraph> <paragraph num="(d)"> <text>Heat treated cream.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.</text> </paragraph> <paragraph num="(46)"> <text>“Recombined” means that a milk or a milk product is made by combining water and nonfat dry milk solids with:</text> <paragraph num="(a)"> <text>Cream;</text> </paragraph> <paragraph num="(b)"> <text>Butterfat; or</text> </paragraph> <paragraph num="(c)"> <text>Milk fat.</text> </paragraph> </paragraph> <paragraph num="(47)"> <text>“Reconstituted” means that a milk or a milk product has resulted from either:</text> <paragraph num="(a)"> <text>Combining dry whole milk solids with the appropriate amount of water; or</text> </paragraph> <paragraph num="(b)"> <text>Adding water to evaporated milk.</text> </paragraph> </paragraph> <paragraph num="(48)"> <text>“Retort processed after packaging” means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to:</text> <paragraph num="(a)"> <text>Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“Sale” means a transaction that involves the:</text> <paragraph num="(a)"> <text>Transfer, dispensing, or serving of milk and milk products with or without charge; or</text> </paragraph> <paragraph num="(b)"> <text>Right to acquire milk and milk products:</text> <paragraph num="(i)"> <text>Through barter or contractual arrangement; or</text> </paragraph> <paragraph num="(ii)"> <text>In exchange for another form of compensation including, but not limited to, an agistment agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(50)"> <text>“Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface.</text> </paragraph> <paragraph num="(51)"> <text>“Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year.</text> </paragraph> <paragraph num="(52)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee.</text> </paragraph> <paragraph num="(53)"> <text>“Sell” means to offer for sale.</text> </paragraph> <paragraph num="(54)"> <text>Skim.</text> <paragraph num="(a)"> <text>“Skim” means a product contains less than 0.5 percent fat.</text> </paragraph> <paragraph num="(b)"> <text>“Skim” has the same meaning as nonfat or fat free.</text> </paragraph> </paragraph> <paragraph num="(55)"> <text>“Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.</text> </paragraph> <paragraph num="(56)"> <text>“Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>In this chapter the following documents are incorporated by reference:</text> <paragraph num="A."> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended;</text> </paragraph> <paragraph num="B."> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;</text> </paragraph> <paragraph num="C."> <text>Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health), which has been incorporated by reference in COMAR 10.15.06.03;</text> </paragraph> <paragraph num="D."> <text>Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health);</text> </paragraph> <paragraph num="E."> <text>21 CFR Parts 100—101, as amended;</text> </paragraph> <paragraph num="F."> <text>21 CFR Part 117;</text> </paragraph> <paragraph num="G."> <text>21 CFR Parts 130—133, as amended;</text> </paragraph> <paragraph num="H."> <text>21 CFR Parts 170—189, as amended;</text> </paragraph> <paragraph num="I."> <text>FDA Food Safety Modernization Act, 21 U.S.C <S2?2201—2252, as amended;</text> </paragraph> <paragraph num="J."> <text>Evaluation of Milk Laboratories, 2015 Revision (Food and Drug Administration and the National Conference on Interstate Milk Shipments, U.S. Department of Health and Human Services);</text> </paragraph> <paragraph num="K."> <text>Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), only:</text> <paragraph num="(1)"> <text>Section 5. Inspection of Dairy Farms and Milk Plants;</text> </paragraph> <paragraph num="(2)"> <text>Section 6. The Examination of Milk and/or Milk Products;</text> </paragraph> <paragraph num="(3)"> <text>Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;</text> </paragraph> <paragraph num="(4)"> <text>Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;</text> </paragraph> <paragraph num="(5)"> <text>Section 8. Animal Health;</text> </paragraph> <paragraph num="(6)"> <text>Section 12. Plans for Construction and Reconstruction;</text> </paragraph> <paragraph num="(7)"> <text>Section 13. Personnel Health;</text> </paragraph> <paragraph num="(8)"> <text>Section 14. Procedure when Infection or High Risk of Infection is Discovered;</text> </paragraph> <paragraph num="(9)"> <text>Section 15. Enforcement;</text> </paragraph> <paragraph num="(10)"> <text>Section 18. Separability Clause;</text> </paragraph> <paragraph num="(11)"> <text>Appendix A. Animal Disease Control;</text> </paragraph> <paragraph num="(12)"> <text>Appendix B. Milk Sampling, Hauling, and Transportation;</text> </paragraph> <paragraph num="(13)"> <text>Appendix C. Dairy Farm Construction Standards and Milk Production;</text> </paragraph> <paragraph num="(14)"> <text>Appendix D. Standards for Water Sources;</text> </paragraph> <paragraph num="(15)"> <text>Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures;</text> </paragraph> <paragraph num="(16)"> <text>Appendix F. Cleaning and Sanitization;</text> </paragraph> <paragraph num="(17)"> <text>Appendix G. Chemical and Bacteriological Tests;</text> </paragraph> <paragraph num="(18)"> <text>Appendix H. Pasteurization Equipment and Procedures and Other Equipment;</text> </paragraph> <paragraph num="(19)"> <text>Appendix I. Pasteurization Equipment and Controls — Tests;</text> </paragraph> <paragraph num="(20)"> <text>Appendix K. HACCP Program;</text> </paragraph> <paragraph num="(21)"> <text>Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products, The Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide, and Rodenticide Act;</text> </paragraph> <paragraph num="(22)"> <text>Appendix M. Reports and Records;</text> </paragraph> <paragraph num="(23)"> <text>Appendix N. Drug Residue Testing and Farm Surveillance;</text> </paragraph> <paragraph num="(24)"> <text>Appendix O. Vitamin Fortification of Fluid Milk Products;</text> </paragraph> <paragraph num="(25)"> <text>Appendix Q. Operation of Automatic Milking Installations for the Production of Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging;</text> </paragraph> <paragraph num="(26)"> <text>Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products; and</text> </paragraph> <paragraph num="(27)"> <text>Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011 (United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs), only:</text> <paragraph num="(1)"> <text>Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);</text> </paragraph> <paragraph num="(2)"> <text>Subpart E, Sec. E1, E 1.4(a)—(e);</text> </paragraph> <paragraph num="(3)"> <text>Subpart E, Sec. E1, E 1.15;</text> </paragraph> <paragraph num="(4)"> <text>Subpart E, Sec. E1, E 1.16;</text> </paragraph> <paragraph num="(5)"> <text>Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;</text> </paragraph> <paragraph num="(6)"> <text>Subpart E, Sec. E 3;</text> </paragraph> <paragraph num="(7)"> <text>Subpart E, Sec. E 4, except for E 4.3.2; and</text> </paragraph> <paragraph num="(8)"> <text>Subpart E, Sec. E 6; and</text> </paragraph> </paragraph> <paragraph num="M."> <text>Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Requirements."> <paragraph num="A."> <text>The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth in and in compliance with the standards, requirements, and procedures specified at:</text> <paragraph num="(1)"> <text>Health-General Article, Title 21, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f;</text> </paragraph> <paragraph num="(3)"> <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(4)"> <text>Bulk Milk Hauler/Sampler Manual;</text> </paragraph> <paragraph num="(5)"> <text>Maryland Laboratory Evaluation Program Manual;</text> </paragraph> <paragraph num="(6)"> <text>Grade “A” Pasteurized Milk Ordinance, only:</text> <paragraph num="(a)"> <text>Sections 5.—6.;</text> </paragraph> <paragraph num="(b)"> <text>Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;</text> </paragraph> <paragraph num="(c)"> <text>Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;</text> </paragraph> <paragraph num="(d)"> <text>Section 8.;</text> </paragraph> <paragraph num="(e)"> <text>Sections 12.—15.;</text> </paragraph> <paragraph num="(f)"> <text>Section 18.;</text> </paragraph> <paragraph num="(g)"> <text>Appendices A.—I.;</text> </paragraph> <paragraph num="(h)"> <text>Appendices K.—O.; and</text> </paragraph> <paragraph num="(i)"> <text>Appendices R.—S.;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, only:</text> <paragraph num="(a)"> <text>Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);</text> </paragraph> <paragraph num="(b)"> <text>Subpart E, Sec. E1, E 1.4(a)—(e);</text> </paragraph> <paragraph num="(c)"> <text>Subpart E, Sec. E1, E 1.15;</text> </paragraph> <paragraph num="(d)"> <text>Subpart E, Sec. E1, E 1.16;</text> </paragraph> <paragraph num="(e)"> <text>Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;</text> </paragraph> <paragraph num="(f)"> <text>Subpart E, Sec. E 3;</text> </paragraph> <paragraph num="(g)"> <text>Subpart E, Sec. E 4, except for E 4.3.2; and</text> </paragraph> <paragraph num="(h)"> <text>Subpart E, Sec. E 6; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Permits Required."> <paragraph num="A."> <text>Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may:</text> <paragraph num="(1)"> <text>Be a:</text> <paragraph num="(a)"> <text>Bobtailer;</text> </paragraph> <paragraph num="(b)"> <text>Bulk milk hauler/sampler;</text> </paragraph> <paragraph num="(c)"> <text>Certified industry dairy farm inspector;</text> </paragraph> <paragraph num="(d)"> <text>Milk processor;</text> </paragraph> <paragraph num="(e)"> <text>Milk producer; or</text> </paragraph> <paragraph num="(f)"> <text>Seasonal milk producer; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Operate a:</text> <paragraph num="(a)"> <text>Distribution station;</text> </paragraph> <paragraph num="(b)"> <text>Milk tank truck cleaning facility;</text> </paragraph> <paragraph num="(c)"> <text>Milk transportation company;</text> </paragraph> <paragraph num="(d)"> <text>Receiving station; or</text> </paragraph> <paragraph num="(e)"> <text>Transfer station.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17 for a milk tank truck.</text> </paragraph> <paragraph num="C."> <text>Decals.</text> <paragraph num="(1)"> <text>When issued a permit, a permittee shall supply and display a decal.</text> </paragraph> <paragraph num="(2)"> <text>The permittee’s decal shall display the following at a height of at least 3 inches:</text> <paragraph num="(a)"> <text>The milk tank truck Maryland permit number; and</text> </paragraph> <paragraph num="(b)"> <text>The words “MD Milk Trans.” in a circle around the permit number.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The permittee’s decal shall be displayed on the rear tank of each milk tank truck.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:</text> <paragraph num="(1)"> <text>A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area;</text> </paragraph> <paragraph num="(3)"> <text>A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if:</text> <paragraph num="(a)"> <text>The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and</text> </paragraph> <paragraph num="(b)"> <text>The milk product is received from a permittee; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An individual who only transports milk in a sealed tanker to a milk plant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Permitting Process."> <paragraph num="A."> <text>Except as otherwise provided in Health-General Article, §§21-410 and 21-411, Annotated Code of Maryland, a person shall obtain a permit from the Secretary before that person may:</text> <paragraph num="(1)"> <text>Bring, send, or receive a milk product into the State for sale;</text> </paragraph> <paragraph num="(2)"> <text>Offer a milk product for sale;</text> </paragraph> <paragraph num="(3)"> <text>Give away a milk product;</text> </paragraph> <paragraph num="(4)"> <text>Store a milk product;</text> </paragraph> <paragraph num="(5)"> <text>Transport a milk product; or</text> </paragraph> <paragraph num="(6)"> <text>Collect official milk samples.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Per Health-General Article, §§21-411, 21-412 and 21-417, Annotated Code of Maryland, an applicant for a permit shall:</text> <paragraph num="(1)"> <text>Submit a complete application to the Secretary for each place of operation on the form that the Secretary provides;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Secretary an annual fee established by the Secretary under Health-General Article, §2-104, Annotated Code of Maryland, and COMAR 10.01.17; and</text> </paragraph> <paragraph num="(3)"> <text>Be an employee of a milk transportation company, if applying for a Maryland Bulk Milk Hauler license, or be an owner of a milk transportation company, if applying for a Milk Transportation Company permit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall issue a permit to an applicant who:</text> <paragraph num="(1)"> <text>Submits a complete application; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the requirements of this chapter for each place of operation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A permit issued by the Secretary:</text> <paragraph num="(1)"> <text>Is not transferable; and</text> </paragraph> <paragraph num="(2)"> <text>Is not valid if there is a change of owner, corporation, partnership, or physical location.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A bulk milk hauler/sampler who holds a permit in another state and picks up and samples raw milk at fewer than three Maryland farms shall obtain a Maryland milk hauler/sampler permit by providing:</text> <paragraph num="(1)"> <text>Documentation of a current bulk hauler/sampler permit from the licensing state, which clearly states the permit expiration date;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of a current field evaluation from the licensing state; and</text> </paragraph> <paragraph num="(3)"> <text>A statement concerning the number of Maryland dairy farms from which the bulk milk hauler/sampler will pick up.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A bulk milk hauler/sampler who holds a permit from another state may pick up and sample raw milk from no more than three Maryland farms without a Maryland field evaluation or written exam.</text> </paragraph> <paragraph num="G."> <text>If a bulk milk hauler/sampler who holds a permit from another state routinely picks up and samples raw milk at three or more Maryland farms, a Maryland field evaluation shall be conducted.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sale of Raw Milk."> <paragraph num="A."> <text>Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell or give away raw milk for human consumption.</text> </paragraph> <paragraph num="B."> <text>A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:</text> <paragraph num="(1)"> <text>Receiving station;</text> </paragraph> <paragraph num="(2)"> <text>Transfer station;</text> </paragraph> <paragraph num="(3)"> <text>Milk plant; or</text> </paragraph> <paragraph num="(4)"> <text>Milk marketing agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Standards for Milk for Manufacturing Purposes."> <paragraph num="A."> <text>The individual in charge of an official laboratory or officially designated laboratory shall ensure that:</text> <paragraph num="(1)"> <text>The laboratory is operated according to the requirements established by the Maryland Laboratory Evaluation Program Manual; and</text> </paragraph> <paragraph num="(2)"> <text>Testing required for raw milk for pasteurization, pasteurized milk products, and dairy product containers and lids is performed according to the requirements established by the Maryland Laboratory Evaluation Program Manual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards and requirements established by:</text> <paragraph num="(1)"> <text>The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text> </paragraph> <paragraph num="(2)"> <text>The Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(3)"> <text>Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>21 CFR Parts 100—101 Food for Human Consumption, General and Food Labeling;</text> </paragraph> <paragraph num="(5)"> <text>21 CFR Parts 131—133 Milk and Cream, Cheeses and Related Cheese Products; and</text> </paragraph> <paragraph num="(6)"> <text>The standards in the following table:</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Inspection and Evaluation of Milk Production, Milk Processing, and Milk Transportation."> <paragraph num="A."> <text>Under the standards set forth in Section 5 of the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect a:</text> <paragraph num="(1)"> <text>Milk plant;</text> </paragraph> <paragraph num="(2)"> <text>Milk producer;</text> </paragraph> <paragraph num="(3)"> <text>Milk tank truck;</text> </paragraph> <paragraph num="(4)"> <text>Milk tank truck cleaning facility;</text> </paragraph> <paragraph num="(5)"> <text>Receiving station;</text> </paragraph> <paragraph num="(6)"> <text>Seasonal milk producer; and</text> </paragraph> <paragraph num="(7)"> <text>Transfer station.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary shall inspect a distribution station at least once every 6 months.</text> </paragraph> <paragraph num="C."> <text>The Secretary shall inspect a bobtailer at least once every 12 months.</text> </paragraph> <paragraph num="D."> <text>The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until milk production for sale has ceased.</text> </paragraph> <paragraph num="E."> <text>Under the standards set forth in Health-General Article, §21-809, Annotated Code of Maryland, and the Grade “A” Pasteurized Milk Ordinance Item 16p.(D)2, the Secretary shall perform equipment tests and examinations at least once every 3 months.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall inspect a milk plant without a pasteurizer at least once every 6 months.</text> </paragraph> <paragraph num="G."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, the Secretary shall evaluate the:</text> <paragraph num="(1)"> <text>Ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling;</text> </paragraph> <paragraph num="(2)"> <text>Pick-up and sampling procedures that a bulk milk hauler/sampler performs; and</text> </paragraph> <paragraph num="(3)"> <text>Sampling procedures of the industry plant sampler.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Secretary shall inspect and evaluate the bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, Sections I through III.</text> </paragraph> <paragraph num="I."> <text>The Secretary shall inspect each milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix B, Section IV.</text> </paragraph> <paragraph num="J."> <text>Under the standards set forth in the Maryland Laboratory Evaluation Program Manual, Evaluation of Milk Laboratories, Standard Methods for the Examination of Dairy Products, and the forms required by the Department, the Secretary shall evaluate a:</text> <paragraph num="(1)"> <text>Laboratory performing manufactured grade milk product testing for official use;</text> </paragraph> <paragraph num="(2)"> <text>Laboratory performing tests for drug residue screening, or tests for both drug residue screening and confirmation; and</text> </paragraph> <paragraph num="(3)"> <text>Laboratory analyst performing required testing.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Reinspections.</text> <paragraph num="(1)"> <text>If an inspection discloses the existence of a violation of a requirement set forth in this chapter, the Secretary shall re-inspect within 30 days, but not before 3 days, to determine compliance with the requirements of Regulation .13 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary finds on the second inspection a violation of the same requirement in this chapter, the Secretary shall issue a notice of intent to suspend the permit.</text> </paragraph> <paragraph num="(3)"> <text>If the Secretary finds a violation of the same requirement as specified on the notice of intent to suspend the permit on an inspection following the date of compliance as specified in the notice of intent to suspend the permit, the Secretary shall suspend the permit in accordance with Regulation .21 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland, or initiate appropriate court action.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Inspection Reports.</text> <paragraph num="(1)"> <text>The Secretary shall:</text> <paragraph num="(a)"> <text>Give one copy of the inspection report to the permittee or other responsible individual; or</text> </paragraph> <paragraph num="(b)"> <text>Post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The permittee may not deface the inspection report and shall make the inspection report available to the Department upon request.</text> </paragraph> <paragraph num="(3)"> <text>The Secretary shall keep a copy of the inspection report on file for 3 years.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Access Required. Upon request of the Secretary, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall permit the Secretary access to all parts of the milk establishment, facility, or transporting vehicle to determine compliance with the provisions of this chapter and Health-General Article, Title 21, Subtitles 2 and 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="N."> <text>Information Required. Upon request, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall furnish the Secretary:</text> <paragraph num="(1)"> <text>A statement of quantities of milk and milk product of each grade purchased and sold;</text> </paragraph> <paragraph num="(2)"> <text>A list of all sources of this milk and milk product; and</text> </paragraph> <paragraph num="(3)"> <text>Records of inspections, tests, and pasteurization times and temperatures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Sampling and Evaluation."> <paragraph num="A."> <text>The following individuals may collect official samples:</text> <paragraph num="(1)"> <text>A dairy plant sampler;</text> </paragraph> <paragraph num="(2)"> <text>An industry plant sampler;</text> </paragraph> <paragraph num="(3)"> <text>A bulk milk hauler/sampler; and</text> </paragraph> <paragraph num="(4)"> <text>A certified Industry Dairy Farm Inspector.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual collecting official milk samples shall collect samples in accordance with the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.</text> </paragraph> <paragraph num="C."> <text>The Secretary shall evaluate the sampling and examination procedures of manufactured grade milk and milk products to ensure that the sampling and examination procedures are conducted according to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.</text> </paragraph> <paragraph num="D."> <text>Can milk shall be sampled and analyzed in accordance with Milk for Manufacturing Purpose and Processing, Section C12(2)(ii) and C12(3)(ii).</text> </paragraph> <paragraph num="E."> <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Item 7p. Administrative Procedures, and Appendix D, the Secretary shall conduct bacteriological testing of individual water supplies:</text> <paragraph num="(1)"> <text>Upon initial approval of the physical structure;</text> </paragraph> <paragraph num="(2)"> <text>Every 6 months after initial approval; and</text> </paragraph> <paragraph num="(3)"> <text>When a repair or alteration of the water supply system has been made.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Secretary shall record and retain for at least 5 years all sample analysis results required under this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Additional Requirements for Transporting of Manufactured Grade Milk."> <paragraph num="A."> <text>A bulk milk hauler/sampler shall:</text> <paragraph num="(1)"> <text>Carry a bulk milk hauler’s permit when operating a milk tank truck, except when a raw milk producer is hauling raw milk from the producer’s farm only to the milk processing plant;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that no interval greater than 2 hours elapses between milk pick-ups from farm to farm, and no more than 24 hours elapses from the first pick-up to delivery of the raw milk to the processing plant;</text> </paragraph> <paragraph num="(3)"> <text>Ensure bulk raw milk is picked up from every dairy farm at least every 3 days;</text> </paragraph> <paragraph num="(4)"> <text>Ensure bulk raw milk is delivered or received by the processor or receiving station within 84 hours of the initial milking;</text> </paragraph> <paragraph num="(5)"> <text>Ensure the temperature of the bulk raw milk does not exceed 50°F;</text> </paragraph> <paragraph num="(6)"> <text>Ensure operations are in accordance with the Bulk Milk Hauler/Sampler Manual; and</text> </paragraph> <paragraph num="(7)"> <text>In accordance with Standard Methods for the Examination of Dairy Products, 3.042, A, ensure proper agitation of the farm bulk tank raw milk.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person may not transfer milk or milk products from a milk transport container or milk tank truck to another container or milk tank truck unless the transfer occurs:</text> <paragraph num="(1)"> <text>From a bulk milk tank to another permitted bulk milk tank truck on the dairy farm where the milk is produced;</text> </paragraph> <paragraph num="(2)"> <text>In a receiving station;</text> </paragraph> <paragraph num="(3)"> <text>In a transfer station; or</text> </paragraph> <paragraph num="(4)"> <text>In a milk plant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Vehicles used for the transportation of can milk or cream shall be enclosed and constructed to protect the product from extreme temperature, dust, or other adverse conditions.</text> </paragraph> <paragraph num="D."> <text>Stainless steel cans used in transporting milk from the dairy farm to a milk facility shall be constructed according to 3-A Sanitary Standards.</text> </paragraph> <paragraph num="E."> <text>Milk transport containers used in transporting milk from the dairy farm to a milk facility shall be approved by the Secretary.</text> </paragraph> <paragraph num="F."> <text>Vehicles used for the transportation of milk from the dairy farms to a milk facility may not be used for any other purpose.</text> </paragraph> <paragraph num="G."> <text>Vehicles used for the transportation of milk shall be equipped with decking boards or racks when more than one tier of milk containers are carried.</text> </paragraph> <paragraph num="H."> <text>The milk tank truck driver shall take responsibility for any official samples that may accompany the milk tank truck.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Improper Handling of Milk Products."> <paragraph num="A."> <text>Under Health-General Article, §21-428, Annotated Code of Maryland, the Secretary shall impound improperly handled milk or milk products that are intended for human consumption.</text> </paragraph> <paragraph num="B."> <text>After impounding the milk or milk product, the Secretary may issue an order requiring one or more of the following actions:</text> <paragraph num="(1)"> <text>Disposing of the milk or milk product;</text> </paragraph> <paragraph num="(2)"> <text>Making the milk or milk product unusable for consumption; or</text> </paragraph> <paragraph num="(3)"> <text>Under Health-General Article, §21-428, Annotated Code of Maryland, imposing a civil monetary penalty, as set forth in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents.</text> </paragraph> <paragraph num="D."> <text>A person subject to an impoundment order may seek legal recourse as set forth in Health-General Article, §21-428, Annotated Code of Maryland, by:</text> <paragraph num="(1)"> <text>Appealing a civil penalty; or</text> </paragraph> <paragraph num="(2)"> <text>Bringing an action for damages.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Labeling."> <paragraph num="A."> <text>A permittee shall ensure that milk product labels conform to the standards and requirements established by:</text> <paragraph num="(1)"> <text>The Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f;</text> </paragraph> <paragraph num="(2)"> <text>The Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text> </paragraph> <paragraph num="(3)"> <text>21 CFR Parts 101, 130, 131, 133, and 170§189;</text> </paragraph> <paragraph num="(4)"> <text>The Grade “A” Pasteurized Milk Ordinance Section 4; and</text> </paragraph> <paragraph num="(5)"> <text>Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A milk processor shall conspicuously mark each package containing manufactured milk products with:</text> <paragraph num="(1)"> <text>The name of the product;</text> </paragraph> <paragraph num="(2)"> <text>The name of the manufacturer;</text> </paragraph> <paragraph num="(3)"> <text>The address of the manufacturer:</text> <paragraph num="(a)"> <text>If listed in the local phone book, the address may consist of the city and state;</text> </paragraph> <paragraph num="(b)"> <text>If not listed in the local phone book, the street address shall be included;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Each ingredient in order of predominance;</text> </paragraph> <paragraph num="(5)"> <text>The net weight of the product in English and metric units;</text> </paragraph> <paragraph num="(6)"> <text>The batch identification of the product;</text> </paragraph> <paragraph num="(7)"> <text>Required nutritional information;</text> </paragraph> <paragraph num="(8)"> <text>If the product is made by reconstitution or recombination, the word “reconstituted” or “recombined” as applicable;</text> </paragraph> <paragraph num="(9)"> <text>If the product is or is made from milk from a hooved mammal other than cattle, the common name of the hooved mammal producing the milk preceding the name of the milk or milk product;</text> </paragraph> <paragraph num="(10)"> <text>In the case of condensed or dry milk products, if distributed by another party, the name and address of the distributor shown by a statement such as “Distributed by”; and</text> </paragraph> <paragraph num="(11)"> <text>The word “Heat-Treated” for heat-treated milk and milk products.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A milk producer shall label all cans of raw milk from the producer’s dairy farm with the milk producer’s name or permit number.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Animal Health."> <text>All raw milk and milk products produced, processed, packaged, and stored under this chapter shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Dairy Farm Construction and Plan Submission."> <text>Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department:</text> <paragraph num="A."> <text>A plan and specifications before:</text> <paragraph num="(1)"> <text>Constructing or reconstructing a:</text> <paragraph num="(a)"> <text>Milk house;</text> </paragraph> <paragraph num="(b)"> <text>Milking barn;</text> </paragraph> <paragraph num="(c)"> <text>Milking stable; or</text> </paragraph> <paragraph num="(d)"> <text>Milking parlor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Converting or remodeling an existing building or structure for use as a:</text> <paragraph num="(a)"> <text>Milk house;</text> </paragraph> <paragraph num="(b)"> <text>Milking barn;</text> </paragraph> <paragraph num="(c)"> <text>Milking stable; or</text> </paragraph> <paragraph num="(d)"> <text>Milking parlor; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Adding, modifying, or replacing:</text> <paragraph num="(a)"> <text>A bulk milk tank;</text> </paragraph> <paragraph num="(b)"> <text>An entire milking system;</text> </paragraph> <paragraph num="(c)"> <text>Any part of a milking system;</text> </paragraph> <paragraph num="(d)"> <text>A washing system;</text> </paragraph> <paragraph num="(e)"> <text>Any part of a washing system; or</text> </paragraph> <paragraph num="(f)"> <text>A cooling system, including a plate cooler or bulk tank cooling system;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;</text> </paragraph> <paragraph num="C."> <text>Contact information for the dairy farm, including:</text> <paragraph num="(1)"> <text>The full name, title, and telephone number of each applicant;</text> </paragraph> <paragraph num="(2)"> <text>The name of the dairy farm;</text> </paragraph> <paragraph num="(3)"> <text>The mailing address;</text> </paragraph> <paragraph num="(4)"> <text>The location; and</text> </paragraph> <paragraph num="(5)"> <text>Directions to the site;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A site drawing showing:</text> <paragraph num="(1)"> <text>The location of:</text> <paragraph num="(a)"> <text>The milk house;</text> </paragraph> <paragraph num="(b)"> <text>The milking barn;</text> </paragraph> <paragraph num="(c)"> <text>The milking stable;</text> </paragraph> <paragraph num="(d)"> <text>The milking parlor; and</text> </paragraph> <paragraph num="(e)"> <text>Each animal housing area; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Approximate distances in feet from the locations in §D(1) of this regulation, to:</text> <paragraph num="(a)"> <text>Cow yards;</text> </paragraph> <paragraph num="(b)"> <text>Ditches;</text> </paragraph> <paragraph num="(c)"> <text>Frost free style watering hydrants;</text> </paragraph> <paragraph num="(d)"> <text>Manure pits;</text> </paragraph> <paragraph num="(e)"> <text>Septic systems;</text> </paragraph> <paragraph num="(f)"> <text>Silos;</text> </paragraph> <paragraph num="(g)"> <text>Streams; and</text> </paragraph> <paragraph num="(h)"> <text>Wells or other approved water systems;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A detailed drawing:</text> <paragraph num="(1)"> <text>Of the interior, indicating dimensions, of:</text> <paragraph num="(a)"> <text>The milk house;</text> </paragraph> <paragraph num="(b)"> <text>The milking barn;</text> </paragraph> <paragraph num="(c)"> <text>The milking stable;</text> </paragraph> <paragraph num="(d)"> <text>The milking parlor; and</text> </paragraph> <paragraph num="(e)"> <text>Each animal housing area; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Showing the location of:</text> <paragraph num="(a)"> <text>Backflow prevention devices;</text> </paragraph> <paragraph num="(b)"> <text>Chemical dispensers;</text> </paragraph> <paragraph num="(c)"> <text>Compressors;</text> </paragraph> <paragraph num="(d)"> <text>Equipment;</text> </paragraph> <paragraph num="(e)"> <text>Floor drains;</text> </paragraph> <paragraph num="(f)"> <text>Frost free style watering hydrants;</text> </paragraph> <paragraph num="(g)"> <text>Hose bibs;</text> </paragraph> <paragraph num="(h)"> <text>Lighting;</text> </paragraph> <paragraph num="(i)"> <text>Pre-coolers;</text> </paragraph> <paragraph num="(j)"> <text>Toilets;</text> </paragraph> <paragraph num="(k)"> <text>Washing systems; and</text> </paragraph> <paragraph num="(l)"> <text>Watering troughs;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>For pipeline and milking system installations:</text> <paragraph num="(1)"> <text>The make, model number, quantity, and specifications of milking equipment including pipeline and milking units;</text> </paragraph> <paragraph num="(2)"> <text>The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute;</text> </paragraph> <paragraph num="(3)"> <text>A drawing of the parlor or barn showing the location of:</text> <paragraph num="(a)"> <text>Milking equipment;</text> </paragraph> <paragraph num="(b)"> <text>Pipelines, including size and length of the piping;</text> </paragraph> <paragraph num="(c)"> <text>Wash lines, including size and length of each wash line;</text> </paragraph> <paragraph num="(d)"> <text>Receivers, if applicable;</text> </paragraph> <paragraph num="(e)"> <text>Pre-coolers, if applicable;</text> </paragraph> <paragraph num="(f)"> <text>Any other milk equipment; and</text> </paragraph> <paragraph num="(g)"> <text>The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A description and diagram of the location of the backflow protection methods or devices that will be installed to protect the:</text> <paragraph num="(a)"> <text>Potable water supply on all plate coolers;</text> </paragraph> <paragraph num="(b)"> <text>Chemical pumps:</text> </paragraph> <paragraph num="(c)"> <text>Water lines; and</text> </paragraph> <paragraph num="(d)"> <text>Other fixtures;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The type, such as gas or electric, and capacity of the hot water heating system; and</text> </paragraph> <paragraph num="(6)"> <text>Information and specifications for booster or supplemental heating systems, if utilized; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>For bulk tank or milk cooling systems installation:</text> <paragraph num="(1)"> <text>A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank;</text> </paragraph> <paragraph num="(2)"> <text>If part of a new installation, specific floor, wall, and ceiling finishes;</text> </paragraph> <paragraph num="(3)"> <text>Bulk tank specifications and cooling system specifications, including:</text> <paragraph num="(a)"> <text>Make;</text> </paragraph> <paragraph num="(b)"> <text>Model number; and</text> </paragraph> <paragraph num="(c)"> <text>Capacity; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Pre-cooler type and British thermal units capability, if applicable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Dairy Farm Requirements."> <paragraph num="A."> <text>The inspection area for a dairy farm includes the:</text> <paragraph num="(1)"> <text>Adjacent storage areas;</text> </paragraph> <paragraph num="(2)"> <text>Cow yard and cattle housing areas;</text> </paragraph> <paragraph num="(3)"> <text>Milk house;</text> </paragraph> <paragraph num="(4)"> <text>Milking barn, stable, or parlor;</text> </paragraph> <paragraph num="(5)"> <text>Surrounding area;</text> </paragraph> <paragraph num="(6)"> <text>Waste disposal areas; and</text> </paragraph> <paragraph num="(7)"> <text>Water supply and its distribution system.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A milk producer shall ensure that:</text> <paragraph num="(1)"> <text>Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .15 of this chapter, as applicable;</text> </paragraph> <paragraph num="(2)"> <text>Water used at a dairy farm:</text> <paragraph num="(a)"> <text>Be obtained from a water supply system that complies with:</text> <paragraph num="(i)"> <text>Environment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 26.04.04.; and</text> </paragraph> <paragraph num="(iii)"> <text>The Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Be installed in a manner that prevents backflow or back-siphoning;</text> </paragraph> <paragraph num="(c)"> <text>Be separate from a nonpotable water supply system so that nonpotable water cannot be drawn or discharged into the potable water supply system;</text> </paragraph> <paragraph num="(d)"> <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text> </paragraph> <paragraph num="(e)"> <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Hand sinks have:</text> <paragraph num="(a)"> <text>Either:</text> <paragraph num="(i)"> <text>Hot and cold running water under pressure; or</text> </paragraph> <paragraph num="(ii)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A supply of hand-cleaning soap or detergent; and</text> </paragraph> <paragraph num="(c)"> <text>A sanitary means of drying hands, such as individual towels or a hand-drying device;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="(5)"> <text>Toilet facilities are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="(6)"> <text>Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and</text> </paragraph> <paragraph num="(7)"> <text>Electrical systems and lighting requirements comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Milk Facility Construction and Plan Submission."> <text>Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:</text> <paragraph num="A."> <text>A plan and specifications before:</text> <paragraph num="(1)"> <text>Constructing, reconstructing, or extensively altering a milk facility;</text> </paragraph> <paragraph num="(2)"> <text>Converting or remodeling an existing building or structure for use as a milk facility;</text> </paragraph> <paragraph num="(3)"> <text>Adding, replacing, relocating, or modifying a milk facility process; or</text> </paragraph> <paragraph num="(4)"> <text>Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work;</text> </paragraph> <paragraph num="C."> <text>Contact information for the facility, including:</text> <paragraph num="(1)"> <text>The full name, title, and telephone number of each applicant;</text> </paragraph> <paragraph num="(2)"> <text>The name of the plant;</text> </paragraph> <paragraph num="(3)"> <text>The mailing address;</text> </paragraph> <paragraph num="(4)"> <text>The location; and</text> </paragraph> <paragraph num="(5)"> <text>Directions to the site;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A narrative describing the scope and purpose of the project, including a projected timeline from start to completion;</text> </paragraph> <paragraph num="E."> <text>An estimate of finished product output per day;</text> </paragraph> <paragraph num="F."> <text>Sample product labels for each product;</text> </paragraph> <paragraph num="G."> <text>A list of:</text> <paragraph num="(1)"> <text>All products to be produced;</text> </paragraph> <paragraph num="(2)"> <text>Raw cream and nonfat, condensed, or any other milk or milk products to be sold; and</text> </paragraph> <paragraph num="(3)"> <text>Single service container sources;</text> </paragraph> </paragraph> <paragraph num="H."> <text>A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:</text> <paragraph num="(1)"> <text>Processing;</text> </paragraph> <paragraph num="(2)"> <text>Chemical storage;</text> </paragraph> <paragraph num="(3)"> <text>Dry storage;</text> </paragraph> <paragraph num="(4)"> <text>Ingredient and product storage;</text> </paragraph> <paragraph num="(5)"> <text>Receiving;</text> </paragraph> <paragraph num="(6)"> <text>Load out;</text> </paragraph> <paragraph num="(7)"> <text>Laboratories;</text> </paragraph> <paragraph num="(8)"> <text>Offices;</text> </paragraph> <paragraph num="(9)"> <text>Restroom facilities;</text> </paragraph> <paragraph num="(10)"> <text>Lockers or a facility for the storage of personal items; and</text> </paragraph> <paragraph num="(11)"> <text>Employees to eat and drink beverages;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A scale drawing showing the location of all equipment, including:</text> <paragraph num="(1)"> <text>Pasteurizers and sterile systems;</text> </paragraph> <paragraph num="(2)"> <text>Milk processing equipment;</text> </paragraph> <paragraph num="(3)"> <text>Fillers;</text> </paragraph> <paragraph num="(4)"> <text>Raw and pasteurized tanks and silos;</text> </paragraph> <paragraph num="(5)"> <text>Clean-in-place (CIP) systems;</text> </paragraph> <paragraph num="(6)"> <text>Glycol water tanks;</text> </paragraph> <paragraph num="(7)"> <text>Recirculating cooling water tanks;</text> </paragraph> <paragraph num="(8)"> <text>Boilers;</text> </paragraph> <paragraph num="(9)"> <text>Boiler makeup tanks;</text> </paragraph> <paragraph num="(10)"> <text>Culinary steam systems; and</text> </paragraph> <paragraph num="(11)"> <text>Blow mold systems;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A scale drawing showing the location of plumbing and plumbing fixtures, including:</text> <paragraph num="(1)"> <text>Water lines;</text> </paragraph> <paragraph num="(2)"> <text>Sewer lines;</text> </paragraph> <paragraph num="(3)"> <text>Hand sinks;</text> </paragraph> <paragraph num="(4)"> <text>Toilets;</text> </paragraph> <paragraph num="(5)"> <text>Utility sinks;</text> </paragraph> <paragraph num="(6)"> <text>Utensil washing sinks;</text> </paragraph> <paragraph num="(7)"> <text>Floor drains;</text> </paragraph> <paragraph num="(8)"> <text>Floor sinks;</text> </paragraph> <paragraph num="(9)"> <text>Hose stations; and</text> </paragraph> <paragraph num="(10)"> <text>All backflow prevention devices;</text> </paragraph> </paragraph> <paragraph num="K."> <text>A legend for each drawing;</text> </paragraph> <paragraph num="L."> <text>Specifications for:</text> <paragraph num="(1)"> <text>Ventilation including, but not limited to, the type and location of:</text> <paragraph num="(a)"> <text>An air filter;</text> </paragraph> <paragraph num="(b)"> <text>An air pump; and</text> </paragraph> <paragraph num="(c)"> <text>A compressor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Construction materials for the building and interior finishes; and</text> </paragraph> <paragraph num="(3)"> <text>Pasteurizer plate coolers, if separate from the pasteurization system;</text> </paragraph> </paragraph> <paragraph num="M."> <text>A list and description of all boiler, glycol, and recirculating water additives and water treatment;</text> </paragraph> <paragraph num="N."> <text>A description of the:</text> <paragraph num="(1)"> <text>Type of disposal for wastewater and sewage;</text> </paragraph> <paragraph num="(2)"> <text>Source and system for the facility’s potable water supply;</text> </paragraph> <paragraph num="(3)"> <text>Lighting fixtures and placement; and</text> </paragraph> <paragraph num="(4)"> <text>Recirculating cooling system;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Specification sheets, including manufacturer and model number of all milk facility equipment;</text> </paragraph> <paragraph num="P."> <text>A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including:</text> <paragraph num="(1)"> <text>Reclamation systems;</text> </paragraph> <paragraph num="(2)"> <text>Standardization procedures or formulation procedures, or both;</text> </paragraph> <paragraph num="(3)"> <text>Vitamin addition protocol; and</text> </paragraph> <paragraph num="(4)"> <text>Draining of product lines;</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component;</text> </paragraph> <paragraph num="R."> <text>Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;</text> </paragraph> <paragraph num="S."> <text>If applicable, information and drawings on how separation from product lines will be accomplished;</text> </paragraph> <paragraph num="T."> <text>Written step-by-step standard operating procedures (SOPs and SSOPs) for the following, if not included in §W of this regulation:</text> <paragraph num="(1)"> <text>Receiving, processing, storing, and packaging of each product;</text> </paragraph> <paragraph num="(2)"> <text>Drug residue testing;</text> </paragraph> <paragraph num="(3)"> <text>Cleaning and sanitization for all equipment;</text> </paragraph> <paragraph num="(4)"> <text>Cleaning and sanitization for the facility; and</text> </paragraph> <paragraph num="(5)"> <text>Product trace back, inclusive of production/make sheet;</text> </paragraph> </paragraph> <paragraph num="U."> <text>A pest control program;</text> </paragraph> <paragraph num="V."> <text>Employee training and personal hygiene practices; and</text> </paragraph> <paragraph num="W."> <text>A food safety plan that complies with 21 CFR Part 117 and at a minimum includes:</text> <paragraph num="(1)"> <text>A written hazard analysis;</text> </paragraph> <paragraph num="(2)"> <text>Written preventive controls that address:</text> <paragraph num="(a)"> <text>Process preventive controls;</text> </paragraph> <paragraph num="(b)"> <text>Food allergens;</text> </paragraph> <paragraph num="(c)"> <text>Sanitation;</text> </paragraph> <paragraph num="(d)"> <text>Supply-chain controls;</text> </paragraph> <paragraph num="(e)"> <text>A product recall plan; and</text> </paragraph> <paragraph num="(f)"> <text>Other hazards identified in the hazard analysis as requiring a preventive control;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Written procedures for monitoring the implementation of the preventive controls as appropriate to the nature of the preventative control and its role in the facility’s food safety system;</text> </paragraph> <paragraph num="(4)"> <text>Written corrective action procedures as appropriate to the nature of the hazard and the nature of the preventive control; and</text> </paragraph> <paragraph num="(5)"> <text>Written verification procedures as appropriate to the nature of the preventative control and its role in the facility’s food safety system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Milk Physical Plant Requirements."> <paragraph num="A."> <text>Water used at the facility shall:</text> <paragraph num="(1)"> <text>Be obtained from a potable water supply system that complies with:</text> <paragraph num="(a)"> <text>Environment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 26.04.04; and</text> </paragraph> <paragraph num="(c)"> <text>The Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be installed in a manner that prevents backflow or back-siphoning;</text> </paragraph> <paragraph num="(3)"> <text>Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system;</text> </paragraph> <paragraph num="(4)"> <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text> </paragraph> <paragraph num="(5)"> <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hand sinks shall have:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Hot and cold running water under pressure; or</text> </paragraph> <paragraph num="(b)"> <text>Warm running water;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supply of hand-cleaning soap or detergent; and</text> </paragraph> <paragraph num="(3)"> <text>A sanitary means of drying hands, such as individual towels or a hand-drying device.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="D."> <text>Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.</text> </paragraph> <paragraph num="E."> <text>Toilet facilities shall:</text> <paragraph num="(1)"> <text>Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text> </paragraph> <paragraph num="(2)"> <text>For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and</text> </paragraph> <paragraph num="(3)"> <text>For a milk plant that is an on-farm processor, if not located within the physical plant building:</text> <paragraph num="(a)"> <text>Be located within 500 feet of the physical plant building;</text> </paragraph> <paragraph num="(b)"> <text>Be accessible at all times that the plant is in operation;</text> </paragraph> <paragraph num="(c)"> <text>Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and</text> </paragraph> <paragraph num="(d)"> <text>Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of 26.04.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>All electrical systems at the facility shall:</text> <paragraph num="(1)"> <text>Comply with State and local electrical laws, ordinances, and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where:</text> <paragraph num="(a)"> <text>Milk or milk products are handled, processed, packaged, or stored; or</text> </paragraph> <paragraph num="(b)"> <text>Containers, utensils, and equipment are washed; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Plan Review Approval."> <paragraph num="A."> <text>An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.</text> </paragraph> <paragraph num="B."> <text>An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in:</text> <paragraph num="(1)"> <text>Regulations .15 and .16 of this chapter for a dairy farm permit; or</text> </paragraph> <paragraph num="(2)"> <text>Regulations .17 and .18 of this chapter for a milk facilities permit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .15, .16, .17, and .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the applicant:</text> <paragraph num="(a)"> <text>That the plan has been received;</text> </paragraph> <paragraph num="(b)"> <text>If additional information is required to complete the plan review;</text> </paragraph> <paragraph num="(c)"> <text>Whether the plan is approved or denied; and</text> </paragraph> <paragraph num="(d)"> <text>Of the appeals process if the plan is denied.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Confidentiality."> <text>The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Suspension and Revocation of Permits."> <paragraph num="A."> <text>When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland, or the Grade “A” Pasteurized Milk Ordinance.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.</text> </paragraph> <paragraph num="D."> <text>If a permit has been suspended more than once, the Secretary may revoke the permit.</text> </paragraph> <paragraph num="E."> <text>The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.</text> </paragraph> <paragraph num="F."> <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c), and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:</text> <paragraph num="(1)"> <text>Department shall:</text> <paragraph num="(a)"> <text>Summarily suspend the permit;</text> </paragraph> <paragraph num="(b)"> <text>Order the permittee to cease operation immediately; and</text> </paragraph> <paragraph num="(c)"> <text>Promptly provide the permittee with:</text> <paragraph num="(i)"> <text>A written notice of the suspension of the permit;</text> </paragraph> <paragraph num="(ii)"> <text>The reasons for the suspension; and</text> </paragraph> <paragraph num="(iii)"> <text>An opportunity to be heard; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Permittee shall immediately cease operation upon the receipt of the summary suspension order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Appeals Process."> <text>In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been:</text> <paragraph num="A."> <text>Denied;</text> </paragraph> <paragraph num="B."> <text>Suspended; or</text> </paragraph> <paragraph num="C."> <text>Revoked.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-405, 21-406, 21-428, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.20 repealed and new Regulations .01—.22 adopted effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="10" heading="Procedures for the Safe Handling and Processing of Seafood"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>All provisions of 21 CFR 123 and §§1240.3(r) — (u) and 1240.60 are incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §21-234, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 6, 1997 (24:20 Md. R. 1404)</annotation> </annotations> </chapter> <chapter num="11" heading="Bottled Water"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approved source” has the meaning stated in Health-General Article, §21-336(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Approving authority” means the agency designated in the laws of another state or country to license or permit a source water, public water supply system, or bottled water plant if that source water, public water supply system, or bottled water plant is located outside the State.</text> </paragraph> <paragraph num="(3)"> <text>“Aquifer” means a formation of soil, sand, rock, gravel, limestone, sandstone, or other geologic material that contains ground water available for collection.</text> </paragraph> <paragraph num="(4)"> <text>“Artesian water” means the product that meets the standard of identity as set forth in 21 CFR §165.110(a)(2)(i).</text> </paragraph> <paragraph num="(5)"> <text>“Borehole” means a well tapped into an aquifer for the purpose of removing water from the aquifer for bottling or dispensing.</text> </paragraph> <paragraph num="(6)"> <text>Bottled Water.</text> <paragraph num="(a)"> <text>“Bottled water” means:</text> <paragraph num="(i)"> <text>Any water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water; and</text> </paragraph> <paragraph num="(ii)"> <text>The product that meets the standards of identity set forth at 21 CFR §165.110(a).</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Bottled water” does not include:</text> <paragraph num="(i)"> <text>Soft drinks; and</text> </paragraph> <paragraph num="(ii)"> <text>A beverage labeled as club soda or seltzer water.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Bottled water plant” means a food processing plant that:</text> <paragraph num="(a)"> <text>Manufactures, packages, or labels bottled water; or</text> </paragraph> <paragraph num="(b)"> <text>Stores water before bottling.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Certified laboratory” means a laboratory certified by:</text> <paragraph num="(a)"> <text>A state's laboratory certification program in accordance with the United States Environmental Protection Agency's primacy conditions under the Agency's Public Water System Supervision Program;</text> </paragraph> <paragraph num="(b)"> <text>The National Environmental Laboratory Accreditation Program; or</text> </paragraph> <paragraph num="(c)"> <text>The United States Environmental Protection Agency.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Community water system” means a public water supply system that:</text> <paragraph num="(a)"> <text>Services at least 15 service connections used by year-round residents; or</text> </paragraph> <paragraph num="(b)"> <text>Regularly serves at least 25 residents throughout the year.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Contaminant” means a physical, chemical, biological, or radiological substance or matter in water.</text> </paragraph> <paragraph num="(11)"> <text>“Department” means the Maryland Department of Health or the Department's designee.</text> </paragraph> <paragraph num="(12)"> <text>“Drinking water” means water that is intended for human consumption.</text> </paragraph> <paragraph num="(13)"> <text>“Finished product water” means drinking water in the form in which it is provided to the consumer.</text> </paragraph> <paragraph num="(14)"> <text>“Ground water” means water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure.</text> </paragraph> <paragraph num="(15)"> <text>“Ground water under the direct influence of surface water” means ground water with:</text> <paragraph num="(a)"> <text>Significant occurrence of insects and other macroorganisms, algae, or other large diameter pathogens such as Giardia lamblia or Cryptosporidium; or</text> </paragraph> <paragraph num="(b)"> <text>Significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH that closely correlate to climatological or surface water conditions.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Mineral water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(iii).</text> </paragraph> <paragraph num="(17)"> <text>“Person-in-charge” means a licensee or other individual responsible for the operation of a bottled water plant.</text> </paragraph> <paragraph num="(18)"> <text>Public Water Supply System.</text> <paragraph num="(a)"> <text>“Public water supply system” means a system providing piped water to the public for human consumption, if the system:</text> <paragraph num="(i)"> <text>Has at least 15 service connections; or</text> </paragraph> <paragraph num="(ii)"> <text>Regularly serves an average of 25 individuals daily at least 60 days out of the year.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Public water supply system” includes a collection, treatment, storage, and distribution facility that is:</text> <paragraph num="(i)"> <text>Under the control of the operator of the system and used primarily in conjunction with the system; and</text> </paragraph> <paragraph num="(ii)"> <text>A collection or pretreatment storage facility not under the control of the operator of the system that is used primarily in connection with the system.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Public water supply system” does not include a special irrigation district.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Source water” means the water that is processed into finished product water.</text> </paragraph> <paragraph num="(20)"> <text>“Spring” means a source of water issuing naturally from the ground, a rock formation, or a fracture onto the land or into a body of water.</text> </paragraph> <paragraph num="(21)"> <text>“Spring water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(vi).</text> </paragraph> <paragraph num="(22)"> <text>“Statement of acceptability” means the approval issued by the approving authority in a state or country in which the water is collected that demonstrates that a source water quality and a method of handling the water pose no threat to the public health.</text> </paragraph> <paragraph num="(23)"> <text>“Type of water” means a product that meets one of the standards of identity set forth in 21 CFR §165.110(a)(2).</text> </paragraph> <paragraph num="(24)"> <text>“Waiver of filtration and disinfection” means written approval from the Department that allows a person to bottle water without filtering and disinfecting the water to exclude and kill microorganisms.</text> </paragraph> <paragraph num="(25)"> <text>“Well” means a hole made in the ground to:</text> <paragraph num="(a)"> <text>Explore for ground water;</text> </paragraph> <paragraph num="(b)"> <text>Obtain or monitor ground water; or</text> </paragraph> <paragraph num="(c)"> <text>Inject water into an underground formation from which ground water can be produced.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>21 CFR Part 129, as amended;</text> </paragraph> <paragraph num="B."> <text>21 CFR §165.110, as amended; and</text> </paragraph> <paragraph num="C."> <text>21 CFR §165.3, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Compliance with Other Chapter."> <paragraph num="A."> <text>The person-in-charge shall comply with this chapter and COMAR 10.15.04 to:</text> <paragraph num="(1)"> <text>Process finished product water; and</text> </paragraph> <paragraph num="(2)"> <text>Design, operate, and maintain a bottled water plant and equipment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding bottled water plants and the processing of drinking water, this chapter takes precedence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licenses."> <paragraph num="A."> <text>The person-in-charge shall obtain a food processing plant license to operate a bottled water plant pursuant to the provisions of:</text> <paragraph num="(1)"> <text>Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.15.04; and</text> </paragraph> <paragraph num="(3)"> <text>This chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall specify on a food processing plant license the types of bottled water product that the licensee is authorized to process, package, or label.</text> </paragraph> <paragraph num="C."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>A bottled water plant is not operated without the license required by Health-General Article, §21-305, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The required food processing plant license is conspicuously posted in a bottled water plant; and</text> </paragraph> <paragraph num="(3)"> <text>The operations in a bottled water plant are limited to the types of water specified on the license, pursuant to §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A person seeking to bottle water in the State shall:</text> <paragraph num="(1)"> <text>Apply for an annual license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Department:</text> <paragraph num="(a)"> <text>Plans and specifications for a bottled water plant in accordance with Health-General Article, §21-321, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Any applicable requirements as outlined in §§E and F of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pay an annual license fee as specified in COMAR 10.01.17.02.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Specific Application Requirements — Initial License. A person seeking an initial license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland, shall submit to the Department the following specific information:</text> <paragraph num="(1)"> <text>A microbiological analysis of each source water completed in accordance with Regulation .06 of this chapter that is dated within 30 days of the Department's receipt of an initial license application;</text> </paragraph> <paragraph num="(2)"> <text>A chemical and radiological analysis of each source water completed in accordance with Regulation .06 of this chapter that is dated within 1 year of the Department's receipt of an initial license application;</text> </paragraph> <paragraph num="(3)"> <text>For a source water located outside the State, a statement of acceptability; and</text> </paragraph> <paragraph num="(4)"> <text>For a type of water manufactured from a source water without filtration or disinfection, a request for a waiver of filtration and disinfection that includes:</text> <paragraph num="(a)"> <text>Analyses of the source water covering a period of at least 3 years that indicate compliance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Detailed information on methods to protect the source water;</text> </paragraph> <paragraph num="(c)"> <text>The procedures and process for bottling the source water in a sanitary manner;</text> </paragraph> <paragraph num="(d)"> <text>A hydrogeological survey with an assessment conducted by a hydrogeologist, professional engineer, or the approving authority that determines that the source of water is not under the direct influence of surface water and meets the requirements set forth in this chapter;</text> </paragraph> <paragraph num="(e)"> <text>A sanitary survey conducted by a hydrogeologist, professional engineer, or the approving authority that documents an evaluation of the drainage area, reservoir, and transmission and storage facilities for the source water and identifies and determines the significance of probable sources of contamination; and</text> </paragraph> <paragraph num="(f)"> <text>A statement that the bottler will notify the Department not later than 5 days from the date of any change in conditions under which the waiver was granted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Specific Application Requirements — Renewal Application. A person seeking to renew a license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland, shall submit to the Department:</text> <paragraph num="(1)"> <text>A microbiological analysis of each source water and type of water in accordance with Regulation .06 of this chapter that is dated within 30 days of the Department's receipt of a license renewal application;</text> </paragraph> <paragraph num="(2)"> <text>A chemical analysis of each source water and type of water completed in accordance with Regulation .06 of this chapter that is dated within 1 year of the Department's receipt of the license renewal application;</text> </paragraph> <paragraph num="(3)"> <text>A radiological analysis of each source water and type of water completed in accordance with Regulation .06 of this chapter that is dated within 4 years of the Department's receipt of the license renewal application;</text> </paragraph> <paragraph num="(4)"> <text>For a source water located outside the State, a statement of acceptability; and</text> </paragraph> <paragraph num="(5)"> <text>If the renewal application includes a waiver of filtration and disinfection previously approved by the Department, a letter of compliance to the Department certifying under personal knowledge and penalty of perjury that the conditions on which the waiver was granted have not changed.</text> </paragraph> </paragraph> <paragraph num="G."> <text>After receiving an initial license and before selling or distributing finished product water, the person-in-charge shall:</text> <paragraph num="(1)"> <text>Have a microbiological, chemical, and radiological analysis of each type of water completed in accordance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that each type of water meets the water quality standards in Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the analyses to the Department.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department shall deny an application for a license if the applicant:</text> <paragraph num="(1)"> <text>Does not meet the requirements of, or a regulation promulgated under, Health-General Article, Title 21, Subtitles 1 — 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively attempts to obtain a license; or</text> </paragraph> <paragraph num="(3)"> <text>Has not demonstrated that each type of water:</text> <paragraph num="(a)"> <text>Is from an approved source;</text> </paragraph> <paragraph num="(b)"> <text>Meets the water quality standards in Regulation .06A of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Is not injurious to the public health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>The Department may suspend or revoke a license if the licensee:</text> <paragraph num="(1)"> <text>Violates or fails to meet the requirements of, or a regulation adopted under, Health-General Article, Title 21, Subtitles 1— 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively obtains a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Water Sources."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>A source of water for finished product water is an approved source;</text> </paragraph> <paragraph num="(2)"> <text>Within the State, a ground water appropriation permit is obtained from the Maryland Department of the Environment as required in COMAR 26.17.06; and</text> </paragraph> <paragraph num="(3)"> <text>A spring is constructed, developed, or improved in accordance with §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Spring Requirements. The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>A spring is constructed, developed, or improved in accordance with the following requirements:</text> <paragraph num="(a)"> <text>A fissure or opening in the geologic formation from which the water flows into the spring is:</text> <paragraph num="(i)"> <text>Enclosed within an encasement of concrete, tile, steel, or another impervious material; or</text> </paragraph> <paragraph num="(ii)"> <text>Otherwise tapped in a manner that ensures the capture of only ground water flowing from the geologic formation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The walls of a spring encasement penetrate the geologic formation from which the water flows to intercept and contain ground water;</text> </paragraph> <paragraph num="(c)"> <text>A spring encasement is provided a cover;</text> </paragraph> <paragraph num="(d)"> <text>The material used in the construction or improvement of the spring does not impart a toxic or deleterious substance to the water;</text> </paragraph> <paragraph num="(e)"> <text>A fence or other physical barrier is used to exclude animals and unauthorized persons from the area within 100 feet of the spring;</text> </paragraph> <paragraph num="(f)"> <text>Water in the spring is transported to the point of bottling or into bulk storage by:</text> <paragraph num="(i)"> <text>Gravity; or</text> </paragraph> <paragraph num="(ii)"> <text>When pumping is required, first flowing by gravity to a separate holding reservoir from which it is extracted and delivered to the point of bottling by use of a pump;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A spring is protected from direct surface water intrusion and other sources of contamination; and</text> </paragraph> <paragraph num="(h)"> <text>A spring does not contain ground water under the direct influence of surface water;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A spring is constructed, developed, or improved in accordance with a plan made by a registered professional engineer or professionally qualified hydrogeologist that:</text> <paragraph num="(a)"> <text>Contains a hydrogeological study and a sanitary survey as set forth in Regulation .04E(4)(d) and (e) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is approved by the approving authority or the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A borehole used to obtain spring water:</text> <paragraph num="(a)"> <text>Is hydraulically connected to an aquifer that supplies a constantly flowing spring;</text> </paragraph> <paragraph num="(b)"> <text>Contains only water that has all the physical properties before treatment as the water that flows naturally to the surface of the earth or into a body of water;</text> </paragraph> <paragraph num="(c)"> <text>Is shown to comply with §B(1)(g) and (h) of this regulation by a hydrogeological study submitted to the Department; and</text> </paragraph> <paragraph num="(d)"> <text>Is constructed in compliance with §B(2) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>A well within the State that is used as a source of finished product water is permitted, constructed, and installed in conformance with COMAR 26.04.04;</text> </paragraph> <paragraph num="(2)"> <text>When bottling artesian water, a hydrogeological report is kept at the plant that shows that the static water level in the well is at some height above the aquifer;</text> </paragraph> <paragraph num="(3)"> <text>When ground water is a source of finished product water, the ground water is not under the direct influence of surface water;</text> </paragraph> <paragraph num="(4)"> <text>A statement of acceptability for a source of water is kept on file at the plant and available for inspection by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>A public water supply system in the State that is used as a source of finished product water is a community water system that complies with COMAR 26.04.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Water Quality Standards and Analyses."> <paragraph num="A."> <text>The person-in-charge shall ensure that:</text> <paragraph num="(1)"> <text>Except as provided in §B(4) of this regulation, contaminant levels in source water and finished product water do not exceed the maximum allowable concentration for contaminants set forth in 21 CFR §165.110(b);</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §A(8) of this regulation, the analyses for all contaminants in source water and finished product water are performed by a certified laboratory using a representative sample and methods set forth in 21 CFR §§165.110(b) and 165.3;</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in §B of this regulation, a representative sample of source water and finished product water is taken and tested for:</text> <paragraph num="(a)"> <text>Microbiological contaminants at least once per week;</text> </paragraph> <paragraph num="(b)"> <text>Chemical contaminants at least once per year; and</text> </paragraph> <paragraph num="(c)"> <text>Radiological contaminants at least once every 4 years;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The analyses results for sampling required in §A(3) of this regulation are submitted to the Department:</text> <paragraph num="(a)"> <text>At the time of application for a license pursuant to Regulation .04E(1), (2), (4)(a), F(1) — (3), and G(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Upon request within 10 days for microbiological contaminants; and</text> </paragraph> <paragraph num="(c)"> <text>Except as provided in §B of this regulation, upon request within 30 days for chemical and every 4 years for radiological contaminants;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When a sample is positive for total coliforms:</text> <paragraph num="(a)"> <text>The total coliforms positive culture medium is analyzed to determine if fecal coliforms are present, except that Escherichia coli may be tested for in lieu of fecal coliforms; and</text> </paragraph> <paragraph num="(b)"> <text>A resample is taken and submitted for testing within 24 hours;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except as provided in §B(4) of this regulation, source water that does not meet the water quality standards in §A of this regulation is not bottled or processed as drinking water;</text> </paragraph> <paragraph num="(7)"> <text>Finished product water that does not meet the water quality standards in §A of this regulation is not offered for human consumption;</text> </paragraph> <paragraph num="(8)"> <text>A representative sample of source water and drinking water for testing is:</text> <paragraph num="(a)"> <text>Taken at a location and time that makes the test results indicative of the quality of the source water or drinking water;</text> </paragraph> <paragraph num="(b)"> <text>Of sufficient volume to allow testing; and</text> </paragraph> <paragraph num="(c)"> <text>At least 100 milliliters in volume for microbiological testing, regardless of analytical method;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A source water is sampled and tested before any treatment or filtration of the source water;</text> </paragraph> <paragraph num="(10)"> <text>Drinking water and source water that are not filtered or disinfected during processing do not contain coliform bacteria;</text> </paragraph> <paragraph num="(11)"> <text>The microbiological contaminants in source water that is filtered or disinfected during processing do not include:</text> <paragraph num="(a)"> <text>Coliform in excess of 36 most probable number of organisms per 100 milliliters;</text> </paragraph> <paragraph num="(b)"> <text>Fecal coliform;</text> </paragraph> <paragraph num="(c)"> <text>Escherichia coli; and</text> </paragraph> <paragraph num="(d)"> <text>Organisms that by number or type indicate the direct influence of or contamination by surface water; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>The contaminant concentration of trihalomethanes in bottled water does not exceed 10 parts per billion.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Exceptions.</text> <paragraph num="(1)"> <text>If a source water is from a public water supply system in the State or outside the State, the person-in-charge may use public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority to demonstrate compliance with the water quality standards for source water set forth in §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Department may waive the requirement for a weekly microbiological analysis of source water that is from a public water supply system in the State or outside the State, if public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority demonstrates compliance with the water quality standards set forth in §A of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Mineral water is exempt from the maximum allowable concentration of chloride, iron, manganese, total dissolved solids, and zinc as provided in 21 CFR §165.110(b)(4)(i)(A).</text> </paragraph> <paragraph num="(4)"> <text>Except for a microbiological contaminant, the Department may approve a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for finished product water based on a review that demonstrates that a treatment of the source water is:</text> <paragraph num="(a)"> <text>Effective in reducing the contaminant level in the finished product water below the maximum allowable concentration; and</text> </paragraph> <paragraph num="(b)"> <text>Interlocked with the bottling system so that:</text> <paragraph num="(i)"> <text>Failure in the treatment inactivates the bottling system; and</text> </paragraph> <paragraph num="(ii)"> <text>Water is prevented from being bottled.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Except for a microbiological contaminant, a person may not process or bottle water from a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for a finished product water, as set forth in §A of this regulation, without written approval from the Department.</text> </paragraph> <paragraph num="D."> <text>The person-in-charge shall:</text> <paragraph num="(1)"> <text>Maintain at the plant:</text> <paragraph num="(a)"> <text>While processing or bottling a source water as set forth in §§B(4) and C of this regulation, the Department's written approval; and</text> </paragraph> <paragraph num="(b)"> <text>A record of the required water sampling and analytical results for at least 2 years; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Make the records available for inspection by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Plant Design and Facilities."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The equipment and facilities needed to store, convey, transport, and bottle drinking water and wash and sanitize bottled water containers and bottling equipment and utensils in accordance with this chapter are provided and maintained in a sanitary condition;</text> </paragraph> <paragraph num="B."> <text>The water supplied to a fixture is potable and meets the requirements in COMAR 26.04.01;</text> </paragraph> <paragraph num="C."> <text>The sewage disposal system for the plant:</text> <paragraph num="(1)"> <text>Meets all applicable State and local codes; and</text> </paragraph> <paragraph num="(2)"> <text>Properly disposes of all wastewater;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Toilet rooms:</text> <paragraph num="(1)"> <text>Are separate for men and women;</text> </paragraph> <paragraph num="(2)"> <text>Are provided at the rate of one toilet for every 15 employees; and</text> </paragraph> <paragraph num="(3)"> <text>Do not open directly into an area in which:</text> <paragraph num="(a)"> <text>Source water or finished product water is handled, processed, or held; and</text> </paragraph> <paragraph num="(b)"> <text>Containers, utensils, or pieces of equipment are washed or held;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A bottling room:</text> <paragraph num="(1)"> <text>Is separated from other plant operations and storage areas by:</text> <paragraph num="(a)"> <text>Tight fitting walls;</text> </paragraph> <paragraph num="(b)"> <text>Ceilings; and</text> </paragraph> <paragraph num="(c)"> <text>Self closing doors;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has conveyor openings only large enough to allow passage of containers;</text> </paragraph> <paragraph num="(3)"> <text>Is mechanically ventilated using exhaust and supply air fans so that:</text> <paragraph num="(a)"> <text>Filtered air is supplied to provide a positive air pressure in the room; and</text> </paragraph> <paragraph num="(b)"> <text>Condensation does not accumulate on room surfaces and equipment;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has a floor sloped to floor drains;</text> </paragraph> <paragraph num="(5)"> <text>Has a floor, walls, and a ceiling that are:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(c)"> <text>Impervious to water;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has a hand sink:</text> <paragraph num="(a)"> <text>In the room; or</text> </paragraph> <paragraph num="(b)"> <text>Directly adjacent to the room; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Has lighting that provides a minimum of 40 foot candles on all work surfaces;</text> </paragraph> </paragraph> <paragraph num="F."> <text>A bottle washing room, if present:</text> <paragraph num="(1)"> <text>Meets the requirements in §E of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Is situated in the plant and has equipment located within the room to minimize postsanitizing contamination of the containers before the containers enter the bottling room;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Clean and uncapped containers are protected from overhead contamination before and after filling with water by:</text> <paragraph num="(1)"> <text>Conveyor covers that meet the design specifications in Regulation .08 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Being held in rooms that have finished ceilings that are:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Easily cleanable; and</text> </paragraph> <paragraph num="(c)"> <text>Free of filth and condensation; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Before making a change, alteration, or addition to equipment or facilities that convey, treat, or bottle drinking water, plans for the change, alteration, or addition are submitted to and approved by the Department, in accordance with Health-General Article, §21-321, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Equipment and Utensils."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Equipment for processing drinking water is:</text> <paragraph num="(1)"> <text>Maintained in a sanitary and working condition;</text> </paragraph> <paragraph num="(2)"> <text>Provided with instrumentation to allow:</text> <paragraph num="(a)"> <text>Process control; and</text> </paragraph> <paragraph num="(b)"> <text>Monitoring;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitored to verify that process requirements are met; and</text> </paragraph> <paragraph num="(4)"> <text>Durable and impervious to water;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Materials used as water contact surfaces of equipment and utensils:</text> <paragraph num="(1)"> <text>Are nontoxic and inert to water under the conditions of use;</text> </paragraph> <paragraph num="(2)"> <text>Do not migrate to or adulterate drinking water;</text> </paragraph> <paragraph num="(3)"> <text>Are nonporous and nonabsorbent; and</text> </paragraph> <paragraph num="(4)"> <text>Are corrosion resistant;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Water contact surfaces of equipment and utensils are:</text> <paragraph num="(1)"> <text>Designed, constructed, and maintained to be:</text> <paragraph num="(a)"> <text>Smooth;</text> </paragraph> <paragraph num="(b)"> <text>Easily cleanable;</text> </paragraph> <paragraph num="(c)"> <text>Free of difficult to clean internal surfaces;</text> </paragraph> <paragraph num="(d)"> <text>Self-emptying or self-draining if an interior surface;</text> </paragraph> <paragraph num="(e)"> <text>Visible for inspection or the equipment is readily disassembled for inspection;</text> </paragraph> <paragraph num="(f)"> <text>If manually cleaned:</text> <paragraph num="(i)"> <text>Readily accessible for cleaning without tools; or</text> </paragraph> <paragraph num="(ii)"> <text>If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cleaned and sanitized:</text> <paragraph num="(a)"> <text>In accordance with 21 CFR §129.80(c) and (d); and</text> </paragraph> <paragraph num="(b)"> <text>As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>When pressurized clean-in-place is used:</text> <paragraph num="(1)"> <text>A cleaning and sanitizing solution is:</text> <paragraph num="(a)"> <text>Fully circulated through a fixed system to contact all interior water contact surfaces;</text> </paragraph> <paragraph num="(b)"> <text>Effective in cleaning and sanitizing water contact surfaces;</text> </paragraph> <paragraph num="(c)"> <text>Used in accordance with the chemical manufacturer's instructions; and</text> </paragraph> <paragraph num="(d)"> <text>Removed from equipment and water contact surfaces prior to drinking water for bottling or dispensing coming into contact with the equipment or water contact surface by:</text> <paragraph num="(i)"> <text>Rinsing the equipment or water contact surface with drinking water that is diverted to waste until the cleaning and sanitizing solutions are evacuated; or</text> </paragraph> <paragraph num="(ii)"> <text>Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The design, construction, and maintenance of a clean-in-place piping system prevents the contamination of drinking water by cleaning and sanitizing chemicals; and</text> </paragraph> <paragraph num="(3)"> <text>The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A record is made that:</text> <paragraph num="(1)"> <text>Documents the:</text> <paragraph num="(a)"> <text>Proper cleaning and sanitizing of:</text> <paragraph num="(i)"> <text>Water contact surfaces; and</text> </paragraph> <paragraph num="(ii)"> <text>Filling and dispensing machines and equipment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and</text> </paragraph> <paragraph num="(c)"> <text>Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and</text> </paragraph> <paragraph num="(3)"> <text>Is available for inspection by the Department; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Before new or remodeled bottling equipment is used to produce finished product water, a plan for the equipment design, construction, installation, and maintenance of the equipment is submitted to and approved by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Unit Processing Operations — Control, Monitoring, and Record Keeping."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>A processing operation that involves the source, transport, storage, treatment, or bottling of drinking water is controlled to prevent a hazard; and</text> </paragraph> <paragraph num="B."> <text>A record is made that:</text> <paragraph num="(1)"> <text>Documents the type and quantity of finished product water produced;</text> </paragraph> <paragraph num="(2)"> <text>Identifies the initial distribution of the finished product water to facilitate, when necessary, the segregation of specific finished product water that may be adulterated or otherwise unfit for human consumption;</text> </paragraph> <paragraph num="(3)"> <text>Is maintained for at least 2 years after the control, observation, or monitoring is done; and</text> </paragraph> <paragraph num="(4)"> <text>Is available for inspection by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Unit Processing Operations — Bulk Storage and Transportation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Water stored in bulk or transported for bottling is from an approved source;</text> </paragraph> <paragraph num="B."> <text>A storage tank, hose, pump, and piping used for loading, transporting, and unloading water meet the requirements set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="C."> <text>A tank used to store drinking water is:</text> <paragraph num="(1)"> <text>Not used for storage of a nonfood product;</text> </paragraph> <paragraph num="(2)"> <text>Closed to exclude all foreign matter;</text> </paragraph> <paragraph num="(3)"> <text>Vented in a sanitary manner; and</text> </paragraph> <paragraph num="(4)"> <text>Sampled weekly and analyzed for coliform bacteria and standard plate count;</text> </paragraph> </paragraph> <paragraph num="D."> <text>The openings in a storage tank and tank truck are:</text> <paragraph num="(1)"> <text>Protected from contamination;</text> </paragraph> <paragraph num="(2)"> <text>Kept sealed or locked when water for bottling is not being transferred; and</text> </paragraph> <paragraph num="(3)"> <text>Not susceptible to damage or tampering;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A tank truck used to transport drinking water is:</text> <paragraph num="(1)"> <text>Cleaned and sanitized as often as necessary to maintain a sanitary condition and at least once per week; and</text> </paragraph> <paragraph num="(2)"> <text>Provided a number or other marking on the outside of the truck; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>A record is made that:</text> <paragraph num="(1)"> <text>Provides the following information for each batch of drinking water delivered:</text> <paragraph num="(a)"> <text>Name of the water hauler;</text> </paragraph> <paragraph num="(b)"> <text>Tanker truck number;</text> </paragraph> <paragraph num="(c)"> <text>Date of shipment;</text> </paragraph> <paragraph num="(d)"> <text>Name of seller;</text> </paragraph> <paragraph num="(e)"> <text>Location of the source water; and</text> </paragraph> <paragraph num="(f)"> <text>Date of delivery;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is maintained for at least 2 years after the record is made; and</text> </paragraph> <paragraph num="(3)"> <text>Is available for inspection by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Unit Processing Operations — Container Sanitation."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Containers are:</text> <paragraph num="(1)"> <text>Protected from contamination; and</text> </paragraph> <paragraph num="(2)"> <text>If multiservice, adequately cleaned, sanitized, and inspected prior to filling in accordance with 21 CFR §129.80(b)(1), (c), and (d);</text> </paragraph> </paragraph> <paragraph num="B."> <text>Container caps are:</text> <paragraph num="(1)"> <text>Stored in a sanitary manner; and</text> </paragraph> <paragraph num="(2)"> <text>Before use:</text> <paragraph num="(a)"> <text>Examined for cleanliness; and</text> </paragraph> <paragraph num="(b)"> <text>Washed, rinsed, and sanitized as necessary to prevent contamination of finished product water; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Records are made at the plant that:</text> <paragraph num="(1)"> <text>Document the proper cleaning and sanitization of containers;</text> </paragraph> <paragraph num="(2)"> <text>Are maintained for at least 2 years; and</text> </paragraph> <paragraph num="(3)"> <text>Are available for inspection by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Unit Processing Operations — Water Treatment."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Unless a waiver of filtration and disinfection is granted by the Department in accordance with Health-General Article, §21-336.1(b), Annotated Code of Maryland, and this chapter, finished product water has undergone:</text> <paragraph num="(1)"> <text>Ozonation, exposure to ultraviolet light, or an equivalent disinfection process approved by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Filtration or other treatment that is necessary for the water to comply with the standards in Regulation .06 of this chapter;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A drinking water treatment:</text> <paragraph num="(1)"> <text>Is effective in providing the required or intended result;</text> </paragraph> <paragraph num="(2)"> <text>Is controlled;</text> </paragraph> <paragraph num="(3)"> <text>Is monitored; and</text> </paragraph> <paragraph num="(4)"> <text>Uses chemicals, materials, and methods that do not impart substances to the water in a concentration that is toxic, harmful, or deleterious; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>If filtration or disinfection of water is used to treat product water, the filtration or disinfection system is:</text> <paragraph num="(1)"> <text>Proven through a review of scientific study to reduce the target microorganisms to an acceptable level;</text> </paragraph> <paragraph num="(2)"> <text>Approved by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Controlled;</text> </paragraph> <paragraph num="(4)"> <text>Monitored; and</text> </paragraph> <paragraph num="(5)"> <text>Interlocked with the bottling system so that a failure in the filtration or disinfection system inactivates the bottling system and water is prevented from being bottled.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Unit Processing Operations — Bottling Drinking Water."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>Finished product water meets the water quality standards set forth in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Containers used in bottling are:</text> <paragraph num="(1)"> <text>Made of food-grade materials;</text> </paragraph> <paragraph num="(2)"> <text>Clean and sanitary when filled with finished product water; and</text> </paragraph> <paragraph num="(3)"> <text>Properly sealed to prevent the contamination of the water after bottling;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Caps and closures are:</text> <paragraph num="(1)"> <text>Made of food-grade materials;</text> </paragraph> <paragraph num="(2)"> <text>Clean and sanitary when used; and</text> </paragraph> <paragraph num="(3)"> <text>Properly sealed onto containers to prevent the contamination of the water after bottling;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Water is bottled in a room that meets the standards set forth in Regulation .07E of this chapter; and</text> </paragraph> <paragraph num="E."> <text>During bottling, access into the bottling room is limited to persons needed for the bottling process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Labeling and Marking of Finished Product Water."> <text>The person-in-charge shall ensure that:</text> <paragraph num="A."> <text>The information required on a container of bottled water is placed on a label attached to the container or marked directly on the container in a way that ensures the information is clear and available to the consumer for the entire shelf life of the bottled water;</text> </paragraph> <paragraph num="B."> <text>The following information is placed on a container of bottled water:</text> <paragraph num="(1)"> <text>The type of water as set forth in Health-General Article, §21-336(c), (f)(2), and (g), Annotated Code of Maryland, 21 CFR §165.110(a), and this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The name and address of the manufacturer or distributor;</text> </paragraph> <paragraph num="(3)"> <text>The net fluid measure of the contents of the container in common and metric units; and</text> </paragraph> <paragraph num="(4)"> <text>A production code as required in Health-General Article, §21-336(f)(1), Annotated Code of Maryland, and 21 CFR §129.80(e); and</text> </paragraph> </paragraph> <paragraph num="C."> <text>The label includes all the information required in 21 CFR §165.110(a).</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-305, 21-306, 21-334, 21-336, and 21-336.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 23, 2009 (36:6 Md. R. 491)</annotation> </annotations> </chapter> <chapter num="12" heading="Procedures for the Safe Handling and Processing of Juice"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Provides the HACCP requirements for juice processors as defined by this chapter.</text> </paragraph> <paragraph num="B."> <text>Does not apply to a retail establishment or a food processing plant that:</text> <paragraph num="(1)"> <text>Makes and sells juice directly to consumers; and</text> </paragraph> <paragraph num="(2)"> <text>Does not sell or distribute juice to another business.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>All provisions of 21 CFR 120 are incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for the Safe Handling and Processing of Juice."> <text>A juice processor, as defined in this chapter, shall comply with all of the requirements of 21 CFR 120.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§21-234 and 21-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 16, 2012 (39:4 Md. R. 337)</annotation> </annotations> </chapter> <chapter num="13" heading="Automatic External Defibrillators at Grocery Stores and Restaurants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes guidelines for periodic inspections and annual maintenance of AEDs at grocery stores and restaurants.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>A grocery store that has an annual gross income of $10,000,000 or less in a calendar year; or</text> </paragraph> <paragraph num="(2)"> <text>A restaurant with:</text> <paragraph num="(a)"> <text>An annual gross income of $1,000,000 or less in a calendar year, exclusive of sales for off-premises consumption; or</text> </paragraph> <paragraph num="(b)"> <text>A seating capacity of less than 100 individuals based on a fire marshal’s determination.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“AED” means automated external defibrillator as defined in COMAR 30.06.01.01.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Grocery store” means a store that has:</text> <paragraph num="(a)"> <text>All major food departments, including produce, meat, seafood, dairy, and canned and packaged goods; or</text> </paragraph> <paragraph num="(b)"> <text>At least one of the major food departments and at least 12,000 square feet of floor space.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“MIEMSS” means the Maryland Institute for Emergency Medical Services Systems.</text> </paragraph> <paragraph num="(5)"> <text>“Restaurant” means a food service facility licensed under COMAR 10.15.03 that prepares food for on-site consumption.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="AED Requirements."> <text>Beginning January 1, 2025, each owner and operator of a grocery store or restaurant subject to this chapter shall:</text> <paragraph num="A."> <text>Place an AED in a prominent area, accessible to employees and customers; and</text> </paragraph> <paragraph num="B."> <text>Maintain the functionality of the AED.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Registration."> <text>Each grocery store or restaurant subject to this chapter shall register with MIEMSS using a form prescribed by MIEMSS in order to:</text> <paragraph num="A."> <text>Make its location publicly available to emergency dispatchers; and</text> </paragraph> <paragraph num="B."> <text>Receive maintenance and recall notices from MIEMSS.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Assurance, Maintenance, and Reporting."> <text>An owner or operator of a grocery store or restaurant subject to this chapter shall:</text> <paragraph num="A."> <text>Maintain:</text> <paragraph num="(1)"> <text>Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the U.S. Food and Drug Administration; and</text> </paragraph> <paragraph num="(2)"> <text>Supplemental equipment with the AED at all times, including:</text> <paragraph num="(a)"> <text>Two sets of defibrillator chest pads that are compatible with the AED;</text> </paragraph> <paragraph num="(b)"> <text>Disposable gloves; and</text> </paragraph> <paragraph num="(c)"> <text>The Maryland Facility AED Report Forms for Cardiac Arrest; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Submit to MIEMSS:</text> <paragraph num="(1)"> <text>A report for each incident of suspected cardiac arrest at the restaurant or grocery store on the Maryland Facility AED Report Form for Cardiac Arrests, including:</text> <paragraph num="(a)"> <text>Contact information for any necessary follow-up; and</text> </paragraph> <paragraph num="(b)"> <text>If created by the AED, any available event code, summary code, recording, or tape; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report provided to the federal Food and Drug Administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inspections."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Monitor a grocery store or restaurant subject to this chapter for compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inspect the grocery store or restaurant as necessary for the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Right to Inspect.</text> <paragraph num="(1)"> <text>The Department may enter, at reasonable times, the property of a grocery store or restaurant for the purposes of inspecting, monitoring, and verifying information relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A person may not deny or interfere with the Department’s entry into a grocery store or restaurant under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An operator shall permit a representative of the Department to examine and copy records of the grocery store or restaurant to verify information relative to the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Report of Inspection. During a grocery store or restaurant inspection, the Department shall:</text> <paragraph num="(1)"> <text>Record the inspection results on an inspection form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Identify on the inspection form the conditions found that violate the provisions of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Notify the grocery store or restaurant operator on the inspection form to correct violations by a specific date;</text> </paragraph> <paragraph num="(4)"> <text>Provide one copy of the inspection report to the grocery store or restaurant operator; and</text> </paragraph> <paragraph num="(5)"> <text>Provide one copy of the inspection report to MIEMSS.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The completed inspection report is a public document that is available for public disclosure in accordance with General Provisions Article, §§4-101—4-601, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104 and 21-330.3, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 16, 2026 (53:3 Md. R. 122)</annotation> </annotations> </chapter> </subtitle> <subtitle num="16" heading="Housing"> <chapter num="01" heading="Migratory Labor Camps" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 15, 1970</annotation> <annotation type="History" subtype="Administrative History">Amended effective December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulations .01C and .04D amended effective December 14, 1979 (6:25 Md. R. 1980)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H amended effective July 5, 1982 (9:13 Md. R. 1351)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed effective April 1, 1991 (18:6 Md. R. 685)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.27 adopted effective April 1, 1991 (18:6 Md. R. 685)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective April 9, 2018 (45:7 Md. R. 345)</annotation> </annotations> </chapter> <chapter num="02" heading="Construction, Equipment, Sanitation, Operation, and Maintenance of Mobile Home Parks"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>It is the purpose and intent of these regulations to establish minimum standards of construction, maintenance, and operation of mobile home parks to protect the health, safety, and general welfare of the public. Construction, enlargement, alteration, or addition may not be permitted without compliance with these regulations.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <text>The following definitions shall apply in the interpretation and enforcement of this chapter:</text> <paragraph num="A."> <text>“Access road” means the road leading from the entrance to the mobile home park to the mobile home spaces throughout the park.</text> </paragraph> <paragraph num="B."> <text>“Approving Authority” means the Secretary of Health or his designee.</text> </paragraph> <paragraph num="C."> <text>“Camping vehicle” means a vehicular accommodation (other than a mobile home) suitable for temporary habitation, used for travel, vacation, or recreational purposes, whose overall length does not exceed 28 feet, or whose gross weight does not exceed 4500 pounds, and is occupied in any one place for a period not exceeding 30 days. Areas where camping vehicles only are accommodated, or State-owned camping areas accommodating other than camping vehicles on an emergency overnight basis, shall be exempted from these regulations.</text> </paragraph> <paragraph num="D."> <text>“Fire prevention authority” means the State Fire Marshal or the fire prevention authority of the local political subdivision.</text> </paragraph> <paragraph num="E."> <text>“Garbage” means all animal and vegetable wastes resulting from the handling, preparing, cooking, and serving of food, exclusive of recognized industrial by-products and human and animal feces.</text> </paragraph> <paragraph num="F."> <text>Mobile Home.</text> <paragraph num="(1)"> <text>“Mobile home” means any portable structure (other than a camping vehicle) designed for use as a conveyance upon highways, having no foundation other than a chassis or removable jacks, and so equipped or constructed as to permit occupancy for dwelling and sleeping purposes.</text> </paragraph> <paragraph num="(2)"> <text>“Dependent mobile home” means a mobile home which does not contain plumbing or plumbing fixtures.</text> </paragraph> <paragraph num="(3)"> <text>“Independent mobile home” means a mobile home which contains a flush toilet or a bath or shower, and is designed or constructed to be connected to utilities and sanitary facilities.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Mobile Home Park.</text> <paragraph num="(1)"> <text>“Mobile home park”, referred to as park, means any area or plot of ground upon which two or more mobile homes occupied for dwelling purposes are located, regardless of whether or not a charge is made for the accommodation.</text> </paragraph> <paragraph num="(2)"> <text>“Mobile home park” does not include a park used to accommodate agriculture or migrant workers.</text> </paragraph> </paragraph> <paragraph num="H."> <text>“Mobile home space” means a plot of ground within a mobile home park designated for the accommodation of one mobile home.</text> </paragraph> <paragraph num="I."> <text>“Permit” means a written permit issued by the Approving Authority in accordance with these regulations.</text> </paragraph> <paragraph num="J."> <text>“Person” means a person, persons, individual, partnership, firm, corporation, company, or association having charge, care, custody, ownership, or control of a park, or part of a park.</text> </paragraph> <paragraph num="K."> <text>“Refuse” means all putrescible, nonputrescible, combustible, noncombustible, and solid waste materials, including garbage, rubbish, and ashes, but not including sewage.</text> </paragraph> <paragraph num="L."> <text>“Right-of-way” means the strip of land used for access roads, motor vehicular traffic, parking, and walkways.</text> </paragraph> <paragraph num="M."> <text>“Service building” means a building housing toilet, bathing facilities, laundry, and any other facilities as may be required by these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Permits."> <paragraph num="A."> <text>General Requirements. It shall be unlawful for any person to operate a park without a permit issued annually by the Approving Authority. Application for the permit shall be made in writing on a form and in a manner prescribed by the Approving Authority, and in the case of a new park, or a park to be materially altered, enlarged, or added to, shall include plans and specifications for the proposed park, alterations, enlargements, or additions. Permits shall be nontransferable and shall be posted in a conspicuous place.</text> </paragraph> <paragraph num="B."> <text>Issuance or Denial of a Permit. When, upon review of the application and following complete inspection of the premises, the Approving Authority is satisfied that the park meets the sanitation requirements (Regulations .04--.14 inclusive) of these regulations, a written permit to operate shall be issued. If the park does not meet the sanitation requirements, the permit shall be denied. Final denial shall be in writing, setting forth the reasons for the denial.</text> </paragraph> <paragraph num="C."> <text>Suspension or Revocation of Permits. A permit may be temporarily suspended by the Approving Authority after due written notification regarding the violation by any person of any of the items outlined under the general sanitation requirements of these regulations, or revoked after a hearing by the Approving Authority upon repeated violation. Any person shall have the right of appeal to the Secretary of Health and, after that, may appeal to the circuit courts of the counties or Baltimore City.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Inspections."> <paragraph num="A."> <text>Right of Entry. The Approving Authority shall have the power to enter at reasonable times upon any private or public property for the purpose of inspecting and investigating conditions relative to the enforcement of these regulations.</text> </paragraph> <paragraph num="B."> <text>Access for Repairs. It shall be incumbent upon every occupant of a mobile home park to allow the owner of it or his agent or employee access to any part of the park or its premises at reasonable times for the purpose of making any repairs or alterations as are necessary to effect compliance with these regulations or with any lawful order issued pursuant to these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Sanitation Requirements—Location, Space, and General Layout."> <paragraph num="A."> <text>Site Location. A park may not be located in swamps or marshes or adjacent to swamps or marshes, or in areas not subject to drainage. Every park shall provide suitable space for recreation. The park grounds shall be maintained in a clean, safe, and sanitary condition at all times.</text> </paragraph> <paragraph num="B."> <text>Park Area. Sufficient area shall be provided in the park to accommodate the designated number of mobile home spaces, necessary access roads and walkways, parking areas for motor vehicles, service buildings where required, play areas, and individual water supply or sewage disposal system, or both, where needed.</text> </paragraph> <paragraph num="C."> <text>Location and Minimum Size of New and Existing Mobile Home Spaces.</text> <paragraph num="(1)"> <text>Mobile home spaces shall be laid out so that the mobile home park is in compliance with local fire codes, local ordinances, the State Fire Prevention Code, and the “Fire Safety Criteria for Manufactured Home Installations, Sites, and Communities” (National Fire Protection Association Standard No. 501A, 1987 Edition) which is incorporated by reference in COMAR 12.03.01.06D. The same space requirements apply to camping vehicles when they are parked on mobile home spaces.</text> </paragraph> <paragraph num="(2)"> <text>In those cases when independent mobile home spaces are not serviced by central sewerage or a central water supply system, or both, the appropriate regulations of the Secretary of Health apply.</text> </paragraph> <paragraph num="(3)"> <text>Each mobile home space shall abut on an access road which has unobstructed access to a street or roadway. The spaces shall be well defined.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Setback. A mobile home may not be located less than 25 feet from any public roadway, street, or public right-of-way, and no part of any structures in the park may obstruct any access road or walkway in the park.</text> </paragraph> <paragraph num="E."> <text>Mobile Home and Camping Vehicle Location. A mobile home or camping vehicle may not be occupied in a park unless it is situated in a mobile home space. An independent mobile home, or camping vehicle containing a flush toilet or a bath or shower, and so designed as to be connected to utilities and sanitary facilities may not be located on a dependent mobile home space.</text> </paragraph> <paragraph num="F."> <text>Right-of-Way and Access Road. Each park established after these regulations have been adopted shall be provided with a right-of-way which shall have a minimum width of 40 feet. This right-of-way shall accommodate the access roads which shall provide for continuous forward movement, and shall connect with a street or roadway and with each mobile home space within the park. The right-of-way may also accommodate walkways and parking spaces for motor vehicles. (See Regulation .10B of this chapter). All access roads shall be paved or otherwise satisfactorily treated to control dust and mud.</text> </paragraph> <paragraph num="G."> <text>Walkways. In parks having a service building, walkways shall be provided from all mobile home spaces to the building. Walkways may not be less than 2 feet wide and shall be hard-surfaced and even to prevent tripping hazards, well marked in daytime, and lighted at night as required in Regulation .10B of this chapter.</text> </paragraph> <paragraph num="H."> <text>Clothes Drying. Outside clothes-drying spaces, or other approved facilities, shall be provided. When central outdoor clothes-drying space is provided, a minimum of 2500 square feet per 100 mobile home spaces, or fraction of that, shall be furnished. Outdoor clothes-drying facilities may be installed on the individual home space as part of the basic facilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Service Building."> <paragraph num="A."> <text>Building and Equipment. If the park accommodates independent mobile homes exclusively, a service building may not be required; however, one is recommended for emergency use. Every park accommodating one or more dependent mobile homes shall be provided with at least one adequately equipped service building.</text> </paragraph> <paragraph num="B."> <text>Required Facilities.</text> <paragraph num="(1)"> <text>The following facilities shall be minimum for parks accommodating from one to ten dependent mobile homes:</text> <paragraph num="(a)"> <text>One flush-type toilet, one lavatory, and a shower or bathtub with hot and cold running water for males; and</text> </paragraph> <paragraph num="(b)"> <text>One flush-type toilet, one lavatory, and a shower or bathtub with hot and cold running water for females.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>One flush-type toilet bowl receptacle shall be provided into which shall be emptied the contents of all portable containers of human excrement. An adequate supply of hot and cold water for cleaning the containers shall be provided. This equipment shall be in a separate room of a service building with a single direct opening to the outside. All plumbing of the service building shall comply with all applicable plumbing codes.</text> </paragraph> <paragraph num="(3)"> <text>For those parks accommodating more than ten dependent mobile homes, the following additional fixtures shall be provided:</text> <paragraph num="(a)"> <text>One lavatory and one shower or bathtub for each sex for every ten additional dependent mobile homes or fraction of that;</text> </paragraph> <paragraph num="(b)"> <text>One flush-type toilet for females for every ten additional dependent mobile homes or fraction of that;</text> </paragraph> <paragraph num="(c)"> <text>One flush-type toilet for males for every additional 15 dependent mobile homes or fraction of that.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Urinals may be substituted for not more than one-third of the additional flush-type toilets required under Sec. B(3).</text> </paragraph> </paragraph> <paragraph num="C."> <text>Location, Construction, Facilities.</text> <paragraph num="(1)"> <text>Where service buildings are required they shall:</text> <paragraph num="(a)"> <text>Be located 20 feet or more from any mobile home and not more than 200 feet from any dependent mobile home.</text> </paragraph> <paragraph num="(b)"> <text>Be of permanent construction, and adequately lighted.</text> </paragraph> <paragraph num="(c)"> <text>Be constructed of water and moisture resistant material to permit frequent washing and cleaning. The floors of the service building shall be of water impervious material other than wood and shall slope to a drain connected to the sewerage system.</text> </paragraph> <paragraph num="(d)"> <text>Have adequate heating facilities to maintain a minimum temperature of 70?F during cold weather, and supply adequate hot water during the time of peak demands.</text> </paragraph> <paragraph num="(e)"> <text>Have all rooms well ventilated, with all openings effectively screened against insects and rodents.</text> </paragraph> <paragraph num="(f)"> <text>Provide adequate compartments for each bathtub or shower and water closet, and a sound resistant wall from floor to ceiling to separate male and female toilet and bathing facilities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Laundry Facilities. Laundry facilities shall be provided in the ratio of one laundry tray and one washing machine, or an automatic washing machine, to every 30 mobile home spaces or fraction of that. These facilities shall be provided in a separate room of a service building or in a separate building.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Water Supply."> <paragraph num="A."> <text>Requirements. A potable water supply, capable of furnishing a minimum of 150 gallons of water per day per mobile home space, and producing a minimum of 20 pounds per square inch of pressure at all mobile home service connections, shall be provided. If a private water supply is used, minimum treatment shall be chlorination by a method acceptable to the Secretary of the Environment or his designee. The water supply may not be installed, altered, improved, or used without written permission of the Secretary of the Environment or his designee.</text> </paragraph> <paragraph num="B."> <text>Service Connections. The water system of the mobile home park shall be connected to all service buildings and made available to all independent mobile home spaces by service connections conforming with all applicable plumbing codes.</text> </paragraph> <paragraph num="C."> <text>Protection of Service Connections. All service connections shall be so constructed and so located that they will not be damaged by the parking of mobile homes, and shall be protected from freezing.</text> </paragraph> <paragraph num="D."> <text>Drinking Fountains. Where drinking fountains are provided for public use, they shall be of a type and placed in locations acceptable to the Secretary of the Environment or his designee.</text> </paragraph> <paragraph num="E."> <text>Self-Contained Units. Water or ice used in the storage tank of a self-contained water unit of a mobile home or camping vehicle shall be obtained only from sources acceptable to the Secretary of the Environment or his designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sewage Disposal."> <paragraph num="A."> <text>Requirements. A sewage disposal system may not be installed, altered, improved, or used without the written permission of the Secretary of the Environment or his designee.</text> </paragraph> <paragraph num="B."> <text>Sewer Connections. Each independent mobile home space shall be equipped with provisions for making a watertight connection between the mobile home drain and the sewer. Each individual sewer connection shall be so constructed that it may be closed when not connected to a mobile home, and when not in use shall be capped so as to prevent the escape of any odors and the entrance of vermin. The connections and installations shall comply with all applicable plumbing codes.</text> </paragraph> <paragraph num="C."> <text>Sewer Lines. All sewer lines shall be laid in accordance with plans approved by the Secretary of the Environment or his designee.</text> </paragraph> <paragraph num="D."> <text>Self-Contained Units. All contents of self-contained sewage storage units of mobile homes or camping vehicles shall be discharged only into an approved sewage disposal system by methods acceptable to the Secretary of the Environment or his designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Garbage and Refuse Disposal."> <paragraph num="A."> <text>Storage, Collection, Disposal. The storage, collection, and disposal of garbage and refuse shall be so managed as to not create health hazards, rodent harborage, insect-breeding areas, accidents, fire hazards, or air pollution.</text> </paragraph> <paragraph num="B."> <text>Containers. All refuse awaiting collection shall be stored in leak-proof, rodent-proof containers with tight-fitting lids and shall be located not more than 150 feet from any mobile home space. Containers shall be provided in sufficient number and capacity for proper storage of all refuse. The lids shall be kept in place while refuse is being stored.</text> </paragraph> <paragraph num="C."> <text>Storage Racks or Platforms. Racks or concrete platforms shall be provided on which to store containers for refuse. These container racks or platforms shall be so designed as to prevent tipping, to minimize spillage, container deterioration, and to facilitate cleaning.</text> </paragraph> <paragraph num="D."> <text>Collection. All refuse shall be collected at least twice weekly, or more often if the need is indicated. When suitable collection service is not available from municipal or private agencies, the park operator shall provide this service. All refuse shall be collected and transported in covered vehicles or covered containers.</text> </paragraph> <paragraph num="E."> <text>Private Disposal. Where municipal or private disposal service is not available, the park operator shall dispose of the refuse in a manner acceptable to the Approving Authority.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Insect and Rodent Control Measures."> <text>Insect and rodent control measures to safeguard the public health and comfort shall be applied in the park as required by the Approving Authority. When rats or other objectionable rodents are known to be in the park, the park operator shall take immediate action, as directed by the Approving Authority, to exterminate them. The Approving Authority may also require the park operator to take suitable measures to control weeds and grasses.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Electrical Service and Exterior Lighting."> <paragraph num="A."> <text>Service Outlet. An electrical outlet supplying at least 115 volts shall be provided for each mobile home space. The installation of all service outlets shall comply with all applicable electrical codes and ordinances. The main power supply line to the park shall be installed in an approved manner.</text> </paragraph> <paragraph num="B."> <text>Exterior Lighting. All access roads, parking areas, and walkways within the park shall be illuminated at night so that the roads, areas, and walkways are clearly visible.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Fuel Storage, Location, and Connections."> <text>All piping from exchangeable fuel storage tanks or cylinders to the mobile homes shall be of copper or other approved metallic tubing and shall be permanently installed and securely fastened in place. All fuel storage tanks or cylinders shall be securely fastened in place and may not be located inside or beneath the mobile home or less than 5 feet from any mobile home exit. Any exception to the above regulation shall bear an approved label acceptable to the State Fire Marshal and the National Board of Fire Underwriters.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Safety and Fire Prevention."> <text>All necessary precautions shall be taken to protect persons on the premises of the park from bodily injury resulting from fire, falls, or other types of injuries. The mobile home park area shall be subject to the regulations of the State or local fire prevention authority.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Penalties."> <text>Any person who violates any of the provisions in these regulations shall be guilty of a misdemeanor and upon conviction of it shall be fined not less than $25, or more than $100, for each offense, and otherwise penalized as provided by law. Each day's failure to comply with any provision shall constitute a separate violation.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Severability."> <text>If any section, subsection, paragraph, sentence, clause or phrase of these regulations should be declared invalid for any reason whatsoever, the decision may not affect the remaining portions of these regulations, which shall remain in full force, and effect; and to this end the provisions of these regulations are hereby declared to be severable.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 1, 1963</annotation> <annotation type="History" subtype="Administrative History">Amended effective June 8, 1965; April 1, 1967; December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Preface and Regulation .01 recodified to Regulations .01 and .01-1, respectively, June 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1G amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective February 28, 1994 (21:4 Md. R. 277)</annotation> </annotations> </chapter> <chapter num="03" heading="Camps"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>It is the purpose and intent of these regulations to establish minimum</text> <text>standards of layout, operation, construction, and maintenance of camps to</text> <text>protect and promote the health, safety, and general welfare of the public.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approving Authority” means the Secretary of Health or his designee.</text> </paragraph> <paragraph num="(2)"> <text>“Camp” means a property consisting of a tract of land and all tents, vehicles, buildings, or other structures pertaining to it used as living quarters or shelter, which is operated gratuitously or for compensation, during any portion of any 5 or more days per annum, and which accommodates five or more persons at any time. However, this definition may not apply to a camp to be used by one family on its own premises, motels, motor courts, migrant labor camps, and mobile home parks.</text> </paragraph> <paragraph num="(3)"> <text>Camping Vehicle.</text> <paragraph num="(a)"> <text>“Camping vehicle” means a vehicular unit which is:</text> <paragraph num="(i)"> <text>Designed for temporary dwelling or sleeping;</text> </paragraph> <paragraph num="(ii)"> <text>Designed without a permanent foundation;</text> </paragraph> <paragraph num="(iii)"> <text>Built or mounted on a vehicle or chassis; and</text> </paragraph> <paragraph num="(iv)"> <text>Driven under its own motive power or mounted on or towed by another vehicle.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Camping vehicle” does not include a mobile home as defined in COMAR 10.16.02.01-1.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Garbage” means all animal and vegetable wastes resulting from the handling, preparing, cooking, and serving of food, exclusive of recognized industrial by-products and human and animal excreta.</text> </paragraph> <paragraph num="(5)"> <text>“Permit” means a written permit issued by the Approving Authority according to these regulations.</text> </paragraph> <paragraph num="(6)"> <text>“Person” means a person, persons, individual, partnership, firm, corporation, company, or association having charge, care, custody, ownership, or control of a camp or part of a camp.</text> </paragraph> <paragraph num="(7)"> <text>“Refuse” means all putrescible, nonputrescible, combustible, noncombustible, and solid waste materials, including garbage, rubbish, and ashes, but not including sewage.</text> </paragraph> <paragraph num="(8)"> <text>“Service building” means a building housing toilet, bathing, laundry, and other sanitary facilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Permits."> <paragraph num="A."> <text>General Requirements. It shall be unlawful for any person to operate a camp without an annual permit issued by the Approving Authority. Application for this permit shall be made in writing on a form and in a manner prescribed by the Approving Authority at least 30 days before the opening of the camp, and in the case of a new camp, or camp to be materially altered, enlarged, or added to, shall include plans and specifications for the proposed camp alterations, enlargements, or additions. Permits shall be nontransferable and shall be posted in a conspicuous place. A separate permit shall be required for each camp.</text> </paragraph> <paragraph num="B."> <text>Issuance or Denial of a Permit. When, upon review of the application and following complete inspection of the premises, the Approving Authority is satisfied that the camp meets the sanitation requirements (Regulations .04 — .12) of these regulations, a written permit to operate shall be issued. If the camp does not meet the sanitation requirements, the permit shall be denied in writing, setting forth the reason for this action.</text> </paragraph> <paragraph num="C."> <text>Suspension or Revocation of Permits. A permit may be temporarily suspended by the Approving Authority after due notification regarding the violation by any person of any of the items outlined under the general sanitation requirements in these regulations, or revoked after a hearing by the Approving Authority upon repeated violation. Any person shall have the right of appeal to the Secretary of Health, and, after that, may appeal to the Circuit Court of the Counties or Baltimore City.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Inspections."> <text>The Approving Authority shall have the right of entry at reasonable times upon any private or public property for the purpose of inspecting and investigating conditions relative to the enforcement of these regulations.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Location, Space, and General Layout."> <paragraph num="A."> <text>Site Location. A camp may not be located in swamps or marshes or adjacent to them, or in areas not properly drained. Measures shall be taken for the eradication or control of poison ivy, poison oak, noxious weeds, mosquitoes, flies, rodents, and poisonous reptiles in the immediate camp area. Adequate guards, signs, or area restrictions shall be provided to reduce accident potential.</text> </paragraph> <paragraph num="B."> <text>Location. The principal camp area in which food is prepared and served and where sleeping quarters are located shall be at least 500 feet from any area in which livestock is kept.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Swimming Pools and Bathing Areas."> <text>A swimming pool or bathing area may not be installed, altered, improved, or used without compliance with applicable regulations. A bathing area may not be used without the written permission of the Approving Authority.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Service Buildings."> <paragraph num="A."> <text>Requirements. In camps using service buildings, the following facilities</text> <paragraph num="(1)"> <text>Toilets 1 per 20 15</text> </paragraph> <paragraph num="(2)"> <text>Urinals 1 per 30</text> </paragraph> <paragraph num="(3)"> <text>Lavatories 1 per 20 20</text> </paragraph> <paragraph num="(4)"> <text>*Showers 1 per 20 20</text> </paragraph> </paragraph> <paragraph num="B."> <text>Compliance. All toilet, shower, lavatory, and laundry facilities shall be provided and maintained in a clean, sanitary condition and kept in good repair at all times. Separate toilet facilities shall be provided for each sex. Facilities shall be easily accessible and conveniently located. All toilet, shower, lavatory, and laundry room facilities shall be acceptable to the Secretary of the Environment or his designee and shall be in conformity with the State Plumbing Code.</text> </paragraph> <paragraph num="C."> <text>Buildings. All service buildings and buildings used for sleeping of living quarters shall have windows or openings for the admission of light and shall be capable of adjustment for purposes of ventilation. All the openings, including doors, shall be properly screened, unless other effective means are provided to control flies and insects. All buildings used for sleeping or living purposes shall be provided with floors which are easily cleaned and in good repair. There shall be at least 3 feet between beds. The beds shall be arranged for head-to-foot or foot-to-foot sleeping.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Water Supply."> <paragraph num="A."> <text>Requirements. A safe, adequate, and conveniently located water supply shall be provided for each camp in compliance with applicable regulations. The water supply may not be installed, altered, or used without the written permission of the Secretary of the Environment or his designee.</text> </paragraph> <paragraph num="B."> <text>Drinking Fountains. Drinking fountains shall be of an approved type and in locations acceptable to the Secretary of the Environment or his designee. Faucets may not be used as drinking fountains. Areas around faucets or drinking fountains shall be drained in a manner acceptable to the Secretary of the Environment or his designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Sewage Disposal."> <text>Requirements. Approved, adequate, and conveniently located toilet facilities shall be provided for each camp in compliance with applicable regulations. A method of sewage disposal may not be installed, altered, or used without the written permission of the Approving Authority.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Garbage and Refuse Disposal."> <paragraph num="A."> <text>Storage, Collection, and Disposal. The storage, collection, and disposal of garbage and refuse shall be managed so as not to create health hazards, rodent harborage, insect-breeding areas, accidents, fire hazards, or air pollution.</text> </paragraph> <paragraph num="B."> <text>Containers. All refuse shall be stored in conveniently located, leak-proof, rodent-proof containers with tight-fitting lids. Containers shall be provided in sufficient number and capacity for proper storage of all refuse.</text> </paragraph> <paragraph num="C."> <text>Storage Racks or Platforms. Racks or concrete platforms shall be provided on which to store containers for refuse. These container racks or platforms shall be designed so as to prevent tipping, to minimize spillage and container deterioration, and to facilitate cleaning.</text> </paragraph> <paragraph num="D."> <text>Collection. All refuse shall be collected at least twice weekly, or more often if the need is indicated. Where suitable collection service is not available from municipal or private agencies, the camp operator shall provide this service. All refuse shall be collected and transported in covered vehicles or covered containers to an approved disposal site.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Insect and Rodent Control Measures."> <text>Insect and rodent control measures to safeguard the public health and comfort shall be used in the camp as required by the Approving Authority.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Electrical Service."> <text>Where electrical service is used, the installation and use of these facilities shall conform with all applicable codes.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Food Service."> <text>Equipment and operation of kitchen, dining halls, and storage room facilities shall comply with the standards administered by the Approving Authority. Refrigeration and storage of food, food handling methods, dishwashing and storage of dishes by procedures meeting the requirements of the standards of the Secretary of Health.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Emergency Medical Care and Hospitalization."> <text>A person qualified to render emergency aid shall be available at all times. A registered nurse or physician licensed to practice in the State should be on the camp staff and available for emergency treatment of illness and accident. The nurse or physician need not be a resident, but should be on call and able to reach the camp within a short period of time. Transportation shall be available at all times for use in case of emergency.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Penalties."> <text>Any person who violates any of the provisions set forth in these regulations shall be guilty of a misdemeanor and upon conviction of it shall be fined not less than $25 or more than $100 for each offense and other penalties as provided by law. Each day's failure to comply with any provision shall constitute a separate violation.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Severability."> <text>If any section, subsection, paragraph, sentence, clause, or phrase of these regulations should be declared invalid for any reason whatsoever, the decision may not affect the remaining portions of these regulations, which shall remain in full force and effect, and to this end the provisions of these regulations are hereby declared to be severable.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, § 2-104, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 15, 1965</annotation> <annotation type="History" subtype="Administrative History">Amended effective June 8, 1965; April 1, 1967; December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Preface codified as Regulation .01 and Regulation .01 amended and recodified to Regulation .01-1 effective March 14, 1994 (21:5 Md. R. 404)</annotation> </annotations> </chapter> <chapter num="04" heading="Transparent Glass Doors in Mercantile Establishments and in Public, Commercial, and Residential Buildings and Structures"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <text>The following definitions shall apply in the interpretation and enforcement of these regulations:</text> <paragraph num="A."> <text>“Commercial building or structure” means a building or structure whose occupants are engaged in, related with, deal with, or are occupied with commerce.</text> </paragraph> <paragraph num="B."> <text>“Commissioner” means the Commissioner of the Department of Health.</text> </paragraph> <paragraph num="C."> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="D."> <text>“Glazing” means the act, art, or trade of setting glass in a sash or frame.</text> </paragraph> <paragraph num="E."> <text>“Mercantile establishment” means a place where one or more persons are employed in which goods, wares, or merchandise are offered for sale and includes a building, shed, or structure, or any part of it, occupied in connection with the establishment.</text> </paragraph> <paragraph num="F."> <text>“Owner” means the owner of the premises, or the lessee of the whole thereof, or the agent in charge of the property.</text> </paragraph> <paragraph num="G."> <text>“Public building” means a factory building, an office building, a mercantile building, a motel or hotel building, a theatre building, a warehouse building, an apartment building, a state or municipal building, a school, hospital, college, university, library, or museum building, a building containing a place of public assembly maintained or leased for pecuniary gain, or any other building open to the public.</text> </paragraph> <paragraph num="H."> <text>“Residential building” means dwelling units occupied solely by the owner and his immediate household.</text> </paragraph> <paragraph num="I."> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="J."> <text>“Sidelights” means fixed panels of transparent glass which form part of, or are immediately adjacent to, and within 6 feet horizontally of the vertical edge of any opening in which doors are located.</text> </paragraph> <paragraph num="K."> <text>“Transparent glass” means material predominantly siliceous in character which is not opaque and through which objects lying beyond are clearly visible. For the purpose of this regulation, rigid transparent plastic material shall be construed as transparent glass.</text> </paragraph> <paragraph num="L."> <text>“Transparent glass door” means a door manually or power actuated, fabricated of transparent glass or transparent safety glazing materials, with a transparent area more than 18 inches wide and with a glazing sill less than 18 inches high.</text> </paragraph> <paragraph num="M."> <text>“Transparent safety glazing materials” means materials which will clearly transmit light and also minimize the possibility of cutting or piercing injuries resulting from breakage of the material. Materials covered by this definition include, but are not limited to, laminated glass, tempered glass, wire glass, and rigid plastics.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This regulation applies throughout the State to all transparent glass doors and fixed adjacent transparent glass sidelights in mercantile establishments and in public, commercial, and residential buildings and structures. After the effective date of these regulations, it shall be unlawful to install in any building in the State any glazing materials not in conformity with the glazing standards of the Building Officials' Conference of America, Inc. (BOCA) Basic Building Code, 1970 Edition and any supplements as may be issued after that, except as noted in §B.</text> </paragraph> <paragraph num="B."> <text>Exceptions.</text> <paragraph num="(1)"> <text>Fixed adjacent transparent glass sidelights 18 inches or less in width with opaque stiles at least 1-3/4 inches in width shall be exempt from the requirements of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>If the ground, floor, or equivalent surface area in the path of approach to a fixed adjacent transparent glass sidelight from either side for a minimum distance of 3 feet from the sidelight is so arranged, constructed, or designed as to deter persons from approaching the sidelight or a permanent barrier is installed in the path of approach, the sidelight shall be exempt from the requirements of this regulation. Decorative pools, horticultural planting, or similar installations shall be considered as indicating that the ground, floor, or equivalent surface area is not a path of approach. Benches and similar barriers which are securely fastened to the floor or wall to prevent their removal shall be considered as blocking the path of approach provided they may not be less than 18 inches in height from the ground, floor, or equivalent surface and extend across at least two-thirds of the total width of the glazed area of the sidelight.</text> </paragraph> <paragraph num="(3)"> <text>Transparent glass doors with a glazing sill at least 18 inches above the ground, floor, or equivalent surface immediately adjacent, shall be exempt from the requirements of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Fixed adjacent transparent glass sidelights supported by opaque sill and wall construction and having a glazing sill at least 18 inches above the ground, floor, or equivalent surface immediately adjacent shall be exempt from the requirements of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>Display windows in any establishment, building, or structure which fall within the definition of a sidelight shall be exempt from the requirements of this regulation if the top of the supporting sill and wall construction is not less than 18 inches above the ground, floor, or equivalent surface immediately adjacent and the interior area is occupied with merchandise or similar displays to clearly indicate to the public that it is not a means of ingress or egress.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Marking."> <paragraph num="A."> <text>General. All transparent glass doors and fixed adjacent transparent glass sidelights shall be marked as required in these regulations regardless of the type of glazing material used in their construction. Marking of all transparent glass doors and fixed adjacent transparent glass sidelights within 6 feet horizontally shall be of an opaque nature placed as described in §B, of this regulation, and shall be of a design which is readily discernible to any person approaching the doors and sidelights from any direction.</text> </paragraph> <paragraph num="B."> <text>Marking Locations. Transparent glass doors and fixed adjacent transparent glass sidelights shall be marked in two areas on the glass surface thereof. One area shall be located at least 30, but not more than 36 inches and the other at least 60, but not more than 66 inches above the ground, floor, or equivalent surface below the door or sidelight.</text> </paragraph> <paragraph num="C."> <text>Marking Dimensions.</text> <paragraph num="(1)"> <text>The marking design shall be:</text> <paragraph num="(a)"> <text>At least 4 inches in diameter if circular;</text> </paragraph> <paragraph num="(b)"> <text>4 inches in its least dimension if elliptical or polygonal; or</text> </paragraph> <paragraph num="(c)"> <text>At least 12 inches in horizontal dimension if the marking is less than 4 inches in its least dimension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The vertical dimension of any marking including lettering may not be less than 1-1/2 inches in height.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Marking Methods. Any of the following methods may be used to alert persons to the presence of transparent glass doors and fixed adjacent transparent glass sidelights in their path of movement:</text> <paragraph num="(1)"> <text>Adhesive strips not less than 1-1/2 inches in vertical dimension extending across at least two-thirds of the total glazed area;</text> </paragraph> <paragraph num="(2)"> <text>Decals;</text> </paragraph> <paragraph num="(3)"> <text>Paint, gilding, or other opaque marking materials;</text> </paragraph> <paragraph num="(4)"> <text>Protective grills at least 4 inches wide, extending the full width of the door, at least 30 inches, but not more than 36 inches from the ground, floor, or equivalent surface.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibility."> <text>The owner of any building used as a mercantile establishment or a public, commercial, or residential building or structure shall be responsible for compliance with the provisions of this regulation.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalty."> <text>Any person, who upon conviction of violating any of the provisions of this regulation, shall be guilty of a misdemeanor and shall be subject to a fine not to exceed $50 for each offense.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Severability."> <text>If any provision of these regulations or the application of it to any person or circumstance is held invalid, the invalidity may not affect other provisions or applications of these regulations which can be given effect without the invalid provision or application and to this end the provisions of these regulations are declared to be severable.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24-207, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 10, 1970</annotation> <annotation type="History" subtype="Administrative History">Amended effective March 3, 1972</annotation> </annotations> </chapter> <chapter num="05" heading="Health Permits for Outdoor Musical Festivals"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs health permits for outdoor musical festivals, as set forth in Business Regulation Article, §§17-1401 — 17-1407, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>In addition to a health permit, a person who wants to be a promoter of an outdoor musical festival shall obtain a safety permit and a promoter license in accordance with Business Regulation Article, §§17-1401 — 17-1407, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>This chapter applies only:</text> <paragraph num="(1)"> <text>If admission is charged to attend the outdoor musical festival;</text> </paragraph> <paragraph num="(2)"> <text>To an outdoor musical festival with 500 or more spectators in attendance for:</text> <paragraph num="(a)"> <text>Carroll County;</text> </paragraph> <paragraph num="(b)"> <text>Frederick County;</text> </paragraph> <paragraph num="(c)"> <text>Kent County;</text> </paragraph> <paragraph num="(d)"> <text>Queen Anne's County; and</text> </paragraph> <paragraph num="(e)"> <text>Washington County; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To an outdoor musical festival with 1,000 or more spectators in attendance for:</text> <paragraph num="(a)"> <text>Anne Arundel County;</text> </paragraph> <paragraph num="(b)"> <text>Baltimore County;</text> </paragraph> <paragraph num="(c)"> <text>Calvert County;</text> </paragraph> <paragraph num="(d)"> <text>Caroline County;</text> </paragraph> <paragraph num="(e)"> <text>Cecil County;</text> </paragraph> <paragraph num="(f)"> <text>Charles County;</text> </paragraph> <paragraph num="(g)"> <text>Dorchester County;</text> </paragraph> <paragraph num="(h)"> <text>Garrett County;</text> </paragraph> <paragraph num="(i)"> <text>Harford County;</text> </paragraph> <paragraph num="(j)"> <text>Prince George's County;</text> </paragraph> <paragraph num="(k)"> <text>Somerset County;</text> </paragraph> <paragraph num="(l)"> <text>St. Mary's County;</text> </paragraph> <paragraph num="(m)"> <text>Talbot County;</text> </paragraph> <paragraph num="(n)"> <text>Wicomico County; and</text> </paragraph> <paragraph num="(o)"> <text>Worcester County.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>This chapter does not apply to an outdoor musical festival held in:</text> <paragraph num="(1)"> <text>Baltimore City;</text> </paragraph> <paragraph num="(2)"> <text>Allegany County;</text> </paragraph> <paragraph num="(3)"> <text>Howard County;</text> </paragraph> <paragraph num="(4)"> <text>Montgomery County;</text> </paragraph> <paragraph num="(5)"> <text>Carroll County by a college or public school; or</text> </paragraph> <paragraph num="(6)"> <text>Kent County by a nonprofit agricultural, charitable, civic, fraternal, religious, social welfare, or war veterans' organization operating in Kent County.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a person who is applying for a health permit as part of the process of applying for a promoter license in order to hold an outdoor musical festival.</text> </paragraph> <paragraph num="(2)"> <text>“Health officer” means the health officer or the health officer's designee for the county in which the outdoor musical festival will be held.</text> </paragraph> <paragraph num="(3)"> <text>“Health permit” means a permit issued by a health officer verifying that an applicant has complied with:</text> <paragraph num="(a)"> <text>This chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Business Regulation Article, §17-1404(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Outdoor musical festival” means an event at which a group of individuals participates in musical entertainment:</text> <paragraph num="(a)"> <text>In an open space;</text> </paragraph> <paragraph num="(b)"> <text>Not in a permanent structure; and</text> </paragraph> <paragraph num="(c)"> <text>Not on publicly owned property.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Permanent structure” means a structure that:</text> <paragraph num="(a)"> <text>Has been approved by the local authority administering building codes to remain in place for a period of more than 180 consecutive days; and</text> </paragraph> <paragraph num="(b)"> <text>Is used for sheltering performers and spectators.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Promoter.</text> <paragraph num="(a)"> <text>“Promoter” means a person who:</text> <paragraph num="(i)"> <text>Organizes, operates, produces, or stages an outdoor musical festival; or</text> </paragraph> <paragraph num="(ii)"> <text>Owns or leases property where an outdoor musical festival is held.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Promoter” does not include the State or a political subdivision of the State.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Promoter license” means a license to act as a promoter issued by the clerk of the circuit court for the county in which the outdoor musical festival will be held.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>The Maryland Medical Protocols for Emergency Medical Services Providers (MIEMSS 1999 Edition) which has been incorporated by reference in COMAR 30.01.02.01, is incorporated by reference in this chapter.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Health Permit Application."> <text>An applicant shall:</text> <paragraph num="A."> <text>Post a cash bond with the application in accordance with the requirements of Regulation .09 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Submit documentation to show that the applicant has obtained approval of the local law enforcement unit to hold the outdoor musical festival; and</text> </paragraph> <paragraph num="C."> <text>Submit a completed health permit application form, plans, and descriptions to the health officer at least 60 days before the date that the festival will be held including:</text> <paragraph num="(1)"> <text>Copies of contracts, leases, agreements, or other documentation that verifies compliance for the provision of health services and facilities, safety, and sanitation at the outdoor musical festival as required in Regulations .05 — .08 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and telephone number of the applicant;</text> </paragraph> <paragraph num="(3)"> <text>The name, address, and telephone number of the property owner where the outdoor musical festival will be held;</text> </paragraph> <paragraph num="(4)"> <text>The location of the outdoor musical festival by:</text> <paragraph num="(a)"> <text>County;</text> </paragraph> <paragraph num="(b)"> <text>Tax district;</text> </paragraph> <paragraph num="(c)"> <text>Plat; and</text> </paragraph> <paragraph num="(d)"> <text>Street or highway location;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The dates and times that the outdoor musical festival will be conducted;</text> </paragraph> <paragraph num="(6)"> <text>A written description, a site plan, and photographs of the outdoor musical festival site;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of local zoning approval for use of the property as a site for an outdoor musical festival;</text> </paragraph> <paragraph num="(8)"> <text>A description of the type of entertainment and events scheduled during the outdoor musical festival;</text> </paragraph> <paragraph num="(9)"> <text>Attendance estimates listed by dates and times;</text> </paragraph> <paragraph num="(10)"> <text>The total number of tickets that will be printed for:</text> <paragraph num="(a)"> <text>Sale; and</text> </paragraph> <paragraph num="(b)"> <text>Complimentary distribution;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>A written description of:</text> <paragraph num="(a)"> <text>The water supply;</text> </paragraph> <paragraph num="(b)"> <text>The toilet facilities and sewage waste disposal method;</text> </paragraph> <paragraph num="(c)"> <text>The hand-washing facilities;</text> </paragraph> <paragraph num="(d)"> <text>Garbage and refuse storage; and</text> </paragraph> <paragraph num="(e)"> <text>Garbage and refuse removal;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>A written plan for:</text> <paragraph num="(a)"> <text>Emergency medical services;</text> </paragraph> <paragraph num="(b)"> <text>Litter control; and</text> </paragraph> <paragraph num="(c)"> <text>If applicable:</text> <paragraph num="(i)"> <text>Temporary food service facilities; and</text> </paragraph> <paragraph num="(ii)"> <text>Overnight placement of recreational vehicles during the outdoor musical festival;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>A statement of compliance with the Worker's Compensation Act; and</text> </paragraph> <paragraph num="(14)"> <text>The signature of the applicant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for Obtaining a Health Permit."> <text>In order to obtain a health permit, an applicant shall submit to the health officer written documentation, such as a contract, service agreement, permit, or similar documentation showing that:</text> <paragraph num="A."> <text>The water supply provided for the outdoor musical festival will be:</text> <paragraph num="(1)"> <text>From a public or individual potable water supply system that is:</text> <paragraph num="(a)"> <text>In conformance with COMAR 26.04.01, 26.04.03, and 26.04.04;</text> </paragraph> <paragraph num="(b)"> <text>Adequate in volume to supply the total quantity of water anticipated for use at the outdoor musical festival using a figure of 5 gallons per spectator per day or less as determined by the health officer or applicable local authority; and</text> </paragraph> <paragraph num="(c)"> <text>Connected to a distribution system so that plumbing fixtures are provided with a potable supply of water in the amounts and pressures as specified in COMAR 09.20.01; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A temporary potable water supply that has been approved by the local health department or applicable local authority;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposal of sewage and waste water generated during the outdoor musical festival will be in accordance with all applicable State and local sewage disposal laws and regulations;</text> </paragraph> <paragraph num="C."> <text>A dump station or sewage waste scavenger service that has been approved by the local health department or applicable local authority will be provided on a daily basis for recreational vehicles that remain overnight on the outdoor musical festival premises;</text> </paragraph> <paragraph num="D."> <text>For the duration of the outdoor musical festival:</text> <paragraph num="(1)"> <text>One drinking fountain will be provided for each group of 500 spectators or fraction of 500 spectators;</text> </paragraph> <paragraph num="(2)"> <text>One designated male toilet facility and one designated female toilet facility will be provided for each group of 200 spectators or fraction of 200 spectators;</text> </paragraph> <paragraph num="(3)"> <text>One designated male hand-washing facility and one designated female hand-washing facility that are supplied with water, soap, and hand towels will be provided for each group of 200 spectators or fraction of 200 spectators;</text> </paragraph> <paragraph num="(4)"> <text>The toilet and hand-washing facilities provided for the outdoor musical festival will be:</text> <paragraph num="(a)"> <text>Permanent on-site facilities if the sewage disposal system has adequate capacity to handle the anticipated flow of waste as determined by the local health department or applicable local authority; or</text> </paragraph> <paragraph num="(b)"> <text>Portable sanitary facilities, with a service contract for daily pumping out of waste and cleaning, that have been approved by the local health department or applicable local authority;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Garbage and refuse storage and removal will be provided so that a health problem, hazard, or nuisance is not created;</text> </paragraph> <paragraph num="(6)"> <text>Litter control measures will be provided to prevent the accumulation of bottles, broken glass, and other sharp and dangerous objects;</text> </paragraph> <paragraph num="(7)"> <text>Weeds and grass will be cut to a height of 3 inches or less as a tick control measure;</text> </paragraph> <paragraph num="(8)"> <text>The site will be kept free of puddles of stagnant water as a mosquito control measure;</text> </paragraph> <paragraph num="(9)"> <text>Lighting will be provided at the following locations when the outdoor musical festival is conducted between the times of sunset and sunrise:</text> <paragraph num="(a)"> <text>Entrances and exits;</text> </paragraph> <paragraph num="(b)"> <text>Toilet and hand-washing areas;</text> </paragraph> <paragraph num="(c)"> <text>Water supply outlets;</text> </paragraph> <paragraph num="(d)"> <text>Food service areas; and</text> </paragraph> <paragraph num="(e)"> <text>Emergency medical treatment areas;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Warning signs or barriers will mark clearly potentially hazardous areas at or adjacent to an outdoor musical festival site, such as:</text> <paragraph num="(a)"> <text>Water;</text> </paragraph> <paragraph num="(b)"> <text>Holes;</text> </paragraph> <paragraph num="(c)"> <text>Drops; or</text> </paragraph> <paragraph num="(d)"> <text>Similar features; and</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Emergency medical services will be provided that meet the requirements of Regulation .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Emergency Medical Services."> <text>An applicant shall ensure that emergency medical services will be provided on-site for the duration of an outdoor musical festival, including from the time of the initial arrival of spectators until the departure of spectators, as evidenced by:</text> <paragraph num="A."> <text>An emergency medical services plan that includes:</text> <paragraph num="(1)"> <text>The expected number of individuals that will attend;</text> </paragraph> <paragraph num="(2)"> <text>Details of arrangements and copies of contracts made to satisfy the requirements of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Confirmation that the local jurisdictional emergency medical services operational program and hospital emergency department have been notified of the location, date, and expected number of attendees of the outdoor musical festival;</text> </paragraph> <paragraph num="(4)"> <text>Approval of the plan by the local jurisdictional emergency medical services operational program;</text> </paragraph> <paragraph num="(5)"> <text>Confirmation of a communication system capable of contacting fire, rescue, police, and 9-1-1 services; and</text> </paragraph> <paragraph num="(6)"> <text>Procedures for the documentation and tracking of patient care and transport;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A plan providing emergency medical staff in the following ratios:</text> <paragraph num="(1)"> <text>Fewer than 5,000 people, a minimum of two first responders who are:</text> <paragraph num="(a)"> <text>Licensed or certified in Maryland in accordance with Education Article, §13-516, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Trained in CPR and the use of automatic defibrillators; and</text> </paragraph> <paragraph num="(c)"> <text>Functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>From 5,000 — 10,000 people, a minimum of:</text> <paragraph num="(a)"> <text>Four first responders who are:</text> <paragraph num="(i)"> <text>Licensed or certified in Maryland in accordance with Education Article, §13-516, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Trained in CPR and the use of automatic defibrillators; and</text> </paragraph> <paragraph num="(iii)"> <text>Functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Two advanced life support providers who are:</text> <paragraph num="(i)"> <text>Licensed or certified in Maryland in accordance with Education Article, §13-516, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>More than 10,000 people, a minimum of:</text> <paragraph num="(a)"> <text>Four first responders who are:</text> <paragraph num="(i)"> <text>Licensed or certified in Maryland in accordance with Education Article, §13-516, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Trained in CPR and the use of automatic defibrillators; and</text> </paragraph> <paragraph num="(iii)"> <text>Functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Two advanced life support providers who are:</text> <paragraph num="(i)"> <text>Licensed or certified in Maryland in accordance with Education Article, §13-516, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>One physician licensed in the State; and</text> </paragraph> <paragraph num="(d)"> <text>One advanced life support ambulance and crew functioning under an emergency medical services operational program as defined in COMAR 30.02.01.01B;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A plan for a health assessment and treatment area that is:</text> <paragraph num="(1)"> <text>An enclosed area that is environmentally controlled to provide protection against extremes of heat or cold;</text> </paragraph> <paragraph num="(2)"> <text>Equipped with cots and blankets;</text> </paragraph> <paragraph num="(3)"> <text>Well lighted and ventilated; and</text> </paragraph> <paragraph num="(4)"> <text>Maintained in a clean and sanitary condition;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A plan for equipment necessary to implement Maryland Medical Protocols for Emergency Medical Services Providers to treat the expected number of injuries anticipated at the outdoor musical festival, which includes:</text> <paragraph num="(1)"> <text>First aid supplies;</text> </paragraph> <paragraph num="(2)"> <text>Defibrillation equipment, including at least one automated external defibrillator with portable oxygen device;</text> </paragraph> <paragraph num="(3)"> <text>Supplies and equipment necessary for the staff required in §B of this regulation to deliver care according to Maryland Medical Protocols for Emergency Medical Services Providers; and</text> </paragraph> <paragraph num="(4)"> <text>Supplies and equipment necessary for the staff to maintain precautions against disease transmission; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>A plan for transportation in the event an individual requires additional care, which includes:</text> <paragraph num="(1)"> <text>An agreement of the local emergency medical services operational program to provide ambulance service; or</text> </paragraph> <paragraph num="(2)"> <text>A contract with a Maryland licensed commercial ambulance service to provide ambulance service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Food Service Facilities."> <text>An applicant shall ensure that a food service facility operating on-site during the outdoor musical festival will meet all applicable food service facility standards as set forth at:</text> <paragraph num="A."> <text>Health-General Article, Title 21, Subtitles 1 — 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.15.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Environmental Noise Control."> <text>An applicant shall ensure that the outdoor musical festival will meet the environmental noise limits as specified in COMAR 26.02.03.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Bond Requirements."> <paragraph num="A."> <text>In St. Mary's County, this regulation does not apply if the applicant owns the property where the outdoor musical festival is held.</text> </paragraph> <paragraph num="B."> <text>Amount of Bond.</text> <paragraph num="(1)"> <text>Except as provided in §§A and B(2) and (3) of this regulation, an applicant shall post with the application for a health permit a cash bond in an amount to be determined by the health officer.</text> </paragraph> <paragraph num="(2)"> <text>The health officer may not set a bond in excess of:</text> <paragraph num="(a)"> <text>$25,000 in Frederick and Washington counties; and</text> </paragraph> <paragraph num="(b)"> <text>$50,000 in the other counties to which this chapter applies.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In St. Mary's County, an applicant may pledge real or personal property instead of posting a cash bond if the applicant submits to the health officer a verified financial statement confirming that the fair market value of the pledged property equals or exceeds the amount of the bond required.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The health officer shall:</text> <paragraph num="(1)"> <text>Keep the bond until 30 days after the end of the outdoor musical festival; and</text> </paragraph> <paragraph num="(2)"> <text>Return to the applicant any money that has not been used and is not needed to satisfy pending claims.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If, within 72 hours after an outdoor musical festival ends, the promoter fails to remove all trash and to begin repair of any damage to property caused or created by the outdoor musical festival or its spectators, including crops and livestock, the health officer may use as much of the bond as necessary for the:</text> <paragraph num="(1)"> <text>Removal of the trash; and</text> </paragraph> <paragraph num="(2)"> <text>Repair of the damage.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person who has a claim against the bond shall submit the claim to the health officer within 30 days after the outdoor musical festival ends.</text> </paragraph> <paragraph num="F."> <text>If a claim is submitted, the health officer shall:</text> <paragraph num="(1)"> <text>Determine the validity of the claim and, if justified, the amount of money needed to cover the claim; and</text> </paragraph> <paragraph num="(2)"> <text>Pay from the bond the amount necessary to cover the claim.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Approval or Denial of Health Permit."> <paragraph num="A."> <text>Within 30 days of receipt of an application, the health officer shall:</text> <paragraph num="(1)"> <text>Review the application and required documentation for a health permit; and</text> </paragraph> <paragraph num="(2)"> <text>Approve or deny the issuance of a health permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the health officer denies the issuance of a health permit as set forth in §A of this regulation, the health officer shall notify the applicant in writing:</text> <paragraph num="(1)"> <text>Of the reason for the denial; and</text> </paragraph> <paragraph num="(2)"> <text>That the applicant has an opportunity for a hearing in accordance with Regulation .15 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Permit Form Requirements."> <text>A health officer shall issue a health permit that stipulates the:</text> <paragraph num="A."> <text>Maximum number of spectators that may be accommodated at any one time on the premises of the outdoor musical festival;</text> </paragraph> <paragraph num="B."> <text>Duration and times of the outdoor musical festival;</text> </paragraph> <paragraph num="C."> <text>Location of the outdoor musical festival; and</text> </paragraph> <paragraph num="D."> <text>Name and address of the:</text> <paragraph num="(1)"> <text>Applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Property owner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Health Permit Posting Requirement."> <text>A promoter shall post the health permit in a conspicuous location at the site of the outdoor musical festival.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Inspections."> <text>The health officer may inspect the site of the outdoor musical festival to verify compliance with this chapter.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Injunctions and Suspension or Revocation of a Health Permit."> <paragraph num="A."> <text>In addition to any other enforcement action set forth in this chapter, a health officer may seek an injunction to enforce the provisions of this chapter.</text> </paragraph> <paragraph num="B."> <text>Suspension or Revocation. The health officer may:</text> <paragraph num="(1)"> <text>Suspend or revoke the health permit if the permit holder:</text> <paragraph num="(a)"> <text>Violates a requirement of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Fraudulently or deceptively obtains a health permit;</text> </paragraph> <paragraph num="(c)"> <text>Fraudulently or deceptively uses a health permit; or</text> </paragraph> <paragraph num="(d)"> <text>Fails to correct a situation that threatens the health, safety, or welfare of a spectator at the outdoor musical festival; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Summarily suspend the health permit and close an outdoor musical festival if protection of the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the health permit is suspended or revoked, the health officer shall give the permit holder:</text> <paragraph num="(1)"> <text>Written notice of the suspension or revocation of the health permit;</text> </paragraph> <paragraph num="(2)"> <text>The reasons for the suspension or revocation; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with Regulation .15 of this chapter, an opportunity for a hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Opportunity for a Hearing."> <paragraph num="A."> <text>Except as provided in §B of this regulation, if a health permit is denied, suspended, or revoked, before the health officer takes final action against the applicant or permit holder, the health officer shall give the applicant or permit holder an opportunity for a hearing pursuant to the Maryland Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>If the health permit is summarily suspended, the health officer shall give the permit holder an opportunity for a hearing pursuant to the Maryland Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The hearing is not required to take place before the health officer takes action against the permit holder.</text> </paragraph> <paragraph num="D."> <text>The suspension is in effect when the notice of suspension is served on the permit holder.</text> </paragraph> <paragraph num="E."> <text>If a hearing is desired, an applicant or permit holder shall request a hearing by submitting to the health officer a written request for a hearing.</text> </paragraph> <paragraph num="F."> <text>To preserve the right to a hearing, an applicant or permit holder shall submit the written request within 10 days of the receipt of the denial, suspension, or revocation notice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Prohibition to Operate."> <paragraph num="A."> <text>A permit holder whose health permit is suspended:</text> <paragraph num="(1)"> <text>Shall cease operation of the outdoor musical festival; and</text> </paragraph> <paragraph num="(2)"> <text>May not resume operation of the outdoor musical festival until:</text> <paragraph num="(a)"> <text>An inspection shows that the condition or conditions responsible for the suspension no longer exist; and</text> </paragraph> <paragraph num="(b)"> <text>The health officer reinstates the health permit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant or permit holder whose health permit is denied or revoked:</text> <paragraph num="(1)"> <text>May not start operation of the outdoor musical festival; and</text> </paragraph> <paragraph num="(2)"> <text>Shall cease operation and may not start or resume operation until:</text> <paragraph num="(a)"> <text>A new application is submitted in accordance with Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>An inspection shows that the condition or conditions responsible for the denial or revocation no longer exist;</text> </paragraph> <paragraph num="(c)"> <text>All requirements of this chapter have been met by the applicant or permit holder; and</text> </paragraph> <paragraph num="(d)"> <text>The health officer issues a health permit.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Business Regulation Article, §17-1404; Health-General Article, §§2-104(b) and (l) and 20-303; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 25, 1980 (7:2 Md. R. 115)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07 repealed and new Regulations .01 — .16 adopted effective September 12, 2005 (32:18 Md. R. 1520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 23, 2013 (40:25 Md. R. 2069)</annotation> </annotations> </chapter> <chapter num="06" heading="Certification for Youth Camps"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not apply to:</text> <paragraph num="A."> <text>Purely social activities of a family or the guests of a family;</text> </paragraph> <paragraph num="B."> <text>Subject to Regulation .03 of this chapter, programs or activities directed or operated by a board of recreation, recreation department, or similar public unit of a county, a municipal corporation as defined by Article 23A, §9, Annotated Code of Maryland, or the Maryland-National Capital Park and Planning Commission, that involve use of neighborhood facilities, including:</text> <paragraph num="(1)"> <text>Schools;</text> </paragraph> <paragraph num="(2)"> <text>Playgrounds;</text> </paragraph> <paragraph num="(3)"> <text>Parks; or</text> </paragraph> <paragraph num="(4)"> <text>Recreation centers;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Subject to Regulation .04 of this chapter, programs or activities directed or operated by an agency of the State that involve occasional use of public facilities, including:</text> <paragraph num="(1)"> <text>Schools;</text> </paragraph> <paragraph num="(2)"> <text>Playgrounds;</text> </paragraph> <paragraph num="(3)"> <text>Parks; or</text> </paragraph> <paragraph num="(4)"> <text>Recreation centers; or</text> </paragraph> </paragraph> <paragraph num="D."> <text>Youth overnight programs sponsored by religious or community organizations operating or conducted for not more than 5 consecutive days during any 1 calendar year, such as a:</text> <paragraph num="(1)"> <text>Vacation bible school;</text> </paragraph> <paragraph num="(2)"> <text>Youth bike trip; or</text> </paragraph> <paragraph num="(3)"> <text>Activity similar to §D(1) or (2) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acceptance letter” means a notice sent to a unit of local government, the Maryland-National Capital Park and Planning Commission, or a State agency, issued by the Department pursuant to this chapter and Health-General Article, §14-403, Annotated Code of Maryland, accepting written certification that the programs or activities operated by:</text> <paragraph num="(a)"> <text>The unit or the Maryland-National Capital Park and Planning Commission comply with Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>The State agency comply with Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Adult” means an individual 18 years old or older or an individual 17 years old who has graduated from high school.</text> </paragraph> <paragraph num="(3)"> <text>Adventure Camp.</text> <paragraph num="(a)"> <text>“Adventure camp” means an activity or program that exposes a camper to a life-threatening or serious injury because of the inherent danger of the activity.</text> </paragraph> <paragraph num="(b)"> <text>“Adventure camp” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Bicycling;</text> </paragraph> <paragraph num="(ii)"> <text>In-line skating;</text> </paragraph> <paragraph num="(iii)"> <text>Piloting an airplane;</text> </paragraph> <paragraph num="(iv)"> <text>A ropes course activity requiring belay or spotting;</text> </paragraph> <paragraph num="(v)"> <text>Skateboarding;</text> </paragraph> <paragraph num="(vi)"> <text>Skydiving;</text> </paragraph> <paragraph num="(vii)"> <text>Snowboarding; or</text> </paragraph> <paragraph num="(viii)"> <text>A similar activity or program.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Adventure camp” does not include a sport activity or program, such as:</text> <paragraph num="(i)"> <text>Baseball;</text> </paragraph> <paragraph num="(ii)"> <text>Basketball;</text> </paragraph> <paragraph num="(iii)"> <text>Field hockey;</text> </paragraph> <paragraph num="(iv)"> <text>Football;</text> </paragraph> <paragraph num="(v)"> <text>Lacrosse;</text> </paragraph> <paragraph num="(vi)"> <text>Soccer;</text> </paragraph> <paragraph num="(vii)"> <text>Softball;</text> </paragraph> <paragraph num="(viii)"> <text>Volleyball; or</text> </paragraph> <paragraph num="(ix)"> <text>A similar sport activity or program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Alternative accreditation” means a national camping standard that:</text> <paragraph num="(a)"> <text>Is acceptable to the Secretary as providing adequate health and safety protection for the campers;</text> </paragraph> <paragraph num="(b)"> <text>Includes an annual monitoring process to verify compliance with the standard; and</text> </paragraph> <paragraph num="(c)"> <text>Complies with Regulation .19 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Assistant counselor” means an individual who is 16 years old or older or an individual who has successfully completed the tenth grade.</text> </paragraph> <paragraph num="(6)"> <text>“Camp” means a youth camp.</text> </paragraph> <paragraph num="(7)"> <text>Camper.</text> <paragraph num="(a)"> <text>“Camper” means an individual younger than 18 years old who is attending a youth camp.</text> </paragraph> <paragraph num="(b)"> <text>“Camper” does not include a child younger than 3-1/2 years old.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Certificate” means a document showing the authority to operate a youth camp, issued by the Department pursuant to this chapter and Health-General Article, §14-403, Annotated Code of Maryland, which displays the name of the person granted the authority.</text> </paragraph> <paragraph num="(9)"> <text>“Community organization” means a local community association or club that:</text> <paragraph num="(a)"> <text>Does not operate for profit; and</text> </paragraph> <paragraph num="(b)"> <text>Sponsors an activity or program for members of the association or club.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Counselor” means an individual who:</text> <paragraph num="(a)"> <text>Has a supervisory role with campers; and</text> </paragraph> <paragraph num="(b)"> <text>Is 18 years old or older or a high school graduate.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Critical violation” means failure to comply with:</text> <paragraph num="(a)"> <text>Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Regulation .21 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.16.07.03A(1) and (2);</text> </paragraph> <paragraph num="(e)"> <text>A majority of the required procedures in COMAR 10.16.07.03A(4) and (5);</text> </paragraph> <paragraph num="(f)"> <text>COMAR 10.16.07.04;</text> </paragraph> <paragraph num="(g)"> <text>COMAR 10.16.07.08A—C;</text> </paragraph> <paragraph num="(h)"> <text>A majority of the required procedures in Regulation .34A of this chapter;</text> </paragraph> <paragraph num="(i)"> <text>A majority of the required procedures in Regulation .35B of this chapter;</text> </paragraph> <paragraph num="(j)"> <text>Regulation .46A(1) and (2) of this chapter;</text> </paragraph> <paragraph num="(k)"> <text>Regulation .47C and F(6)—(9) of this chapter;</text> </paragraph> <paragraph num="(l)"> <text>Regulation .48D(1) of this chapter;</text> </paragraph> <paragraph num="(m)"> <text>Regulation .49C of this chapter;</text> </paragraph> <paragraph num="(n)"> <text>Regulation .50B of this chapter;</text> </paragraph> <paragraph num="(o)"> <text>Regulation .51B of this chapter;</text> </paragraph> <paragraph num="(p)"> <text>Regulation .52A(1) and B(1) of this chapter;</text> </paragraph> <paragraph num="(q)"> <text>A majority of the required procedures in Regulation .52A(2)—(5) of this chapter;</text> </paragraph> <paragraph num="(r)"> <text>Regulation .53A(1) and (2) of this chapter; or</text> </paragraph> <paragraph num="(s)"> <text>Regulation .54 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Day” means all or part of a 24-hour period beginning at 12 a.m.</text> </paragraph> <paragraph num="(13)"> <text>“Day camp” means a youth camp that:</text> <paragraph num="(a)"> <text>Is operated for all or part of the day but less than 24 hours a day;</text> </paragraph> <paragraph num="(b)"> <text>Is conducted for at least 7 calendar days during a 3-week period; and</text> </paragraph> <paragraph num="(c)"> <text>Provides three or more recreational activities or any one specialized activity or program.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(15)"> <text>“Director” means an individual or the individual's designee who in either case:</text> <paragraph num="(a)"> <text>Is 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Possesses at least 24 weeks of previous experience in a camping or children's program as an administrator or a supervisor; and</text> </paragraph> <paragraph num="(c)"> <text>Holds the primary overall responsibility of the administration of camp program operations and support services.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Formal instructor training” means an established program for a specialized activity that:</text> <paragraph num="(a)"> <text>Includes an organized curriculum focusing on instruction technique, safety, supervision, and equipment management in the activity offered;</text> </paragraph> <paragraph num="(b)"> <text>Requires demonstration of the individual's instruction techniques; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluates the individual's knowledge and skill in instruction techniques.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Good standing” means:</text> <paragraph num="(a)"> <text>Compliance with the:</text> <paragraph num="(i)"> <text>Annual report and self-assessment submission requirements as specified in Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Application procedure and fee requirements as specified in Regulation .08 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A camp that in the previous calendar year paid the application fee as set forth in COMAR 10.01.17.02; and</text> </paragraph> <paragraph num="(c)"> <text>Had no critical violations of this chapter found by the Department during an inspection:</text> <paragraph num="(i)"> <text>In the last 2 calendar years; or</text> </paragraph> <paragraph num="(ii)"> <text>For a camp in good standing, in the last calendar year that an inspection took place.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“High ropes” means an adventure camp course activity where the potential drop to the ground for the camper exceeds 3 feet.</text> </paragraph> <paragraph num="(19)"> <text>Instructor.</text> <paragraph num="(a)"> <text>When a national instructor certification organization is available for a specialized activity, “instructor” means an individual who is 18 years old or older or a high school graduate who has documented experience indicating knowledge and skill in teaching specific to the activity conducted, such as:</text> <paragraph num="(i)"> <text>An instructor's certificate from a national organization; or</text> </paragraph> <paragraph num="(ii)"> <text>A letter of reference from a national organization, school authority, or certified instructor trainer.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When a national instructor certification organization is not available for a specialized activity, “instructor” means an individual who is 18 years old or older or a high school graduate who has documented experience indicating knowledge and skill in teaching specific to the activity conducted, such as:</text> <paragraph num="(i)"> <text>A college course in teaching the activity conducted;</text> </paragraph> <paragraph num="(ii)"> <text>A letter of reference from a school authority, certified instructor trainer, or regional authority;</text> </paragraph> <paragraph num="(iii)"> <text>A State-certified public or nonpublic school teacher who has 6 weeks of experience supervising or teaching the activity; or</text> </paragraph> <paragraph num="(iv)"> <text>Proof of satisfactory completion of formal instructor training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Letter of compliance” means a notice to an operator of a youth camp directed or operated by a bona fide religious organization, issued by the Department pursuant to this chapter and Health-General Article, §14-403, Annotated Code of Maryland, granting the operator the authority to operate the youth camp.</text> </paragraph> <paragraph num="(21)"> <text>Occasional Use.</text> <paragraph num="(a)"> <text>“Occasional use” means periodic involvement in a program where there is no expectation of regular attendance.</text> </paragraph> <paragraph num="(b)"> <text>“Occasional use” includes allowing a participant to come to and leave the program at will.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Operate” means to supervise, control, conduct, or manage a youth camp as:</text> <paragraph num="(a)"> <text>An owner;</text> </paragraph> <paragraph num="(b)"> <text>An agent of the owner;</text> </paragraph> <paragraph num="(c)"> <text>A lessee of the owner;</text> </paragraph> <paragraph num="(d)"> <text>A director; or</text> </paragraph> <paragraph num="(e)"> <text>An independent contractor.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Operator” means a person who owns, supervises, controls, conducts, or manages a youth camp.</text> </paragraph> <paragraph num="(24)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(25)"> <text>“Personnel administrator” means an adult who is 21 years old or older and:</text> <paragraph num="(a)"> <text>Has completed a:</text> <paragraph num="(i)"> <text>National and State criminal history records check through the Maryland Department of Public Safety and Correctional Services using the Department’s authorization number; and</text> </paragraph> <paragraph num="(ii)"> <text>Child Protective Services background clearance using the Department’s contact information; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Who the Department has determined is eligible to serve according to Regulation .21D—H of this chapter.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Potentially hazardous food” has the meaning stated in COMAR 10.15.03.</text> </paragraph> <paragraph num="(27)"> <text>“Primarily recreational activities” means that 50 percent or more of a camper's time at camp is spent in recreational activities.</text> </paragraph> <paragraph num="(28)"> <text>“Primitive camp” means a day camp or residential camp where permanent facilities for water supply and sewage disposal systems, food service facilities, sleeping areas, bathing facilities, and hand-washing facilities are not available.</text> </paragraph> <paragraph num="(29)"> <text>Recreational Activity.</text> <paragraph num="(a)"> <text>“Recreational activity” means a pleasurable, interesting, and entertaining activity.</text> </paragraph> <paragraph num="(b)"> <text>“Recreational activity” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Structured or unstructured play;</text> </paragraph> <paragraph num="(ii)"> <text>A nature walk;</text> </paragraph> <paragraph num="(iii)"> <text>A field trip;</text> </paragraph> <paragraph num="(iv)"> <text>A sports activity;</text> </paragraph> <paragraph num="(v)"> <text>A game;</text> </paragraph> <paragraph num="(vi)"> <text>A hobby;</text> </paragraph> <paragraph num="(vii)"> <text>Music;</text> </paragraph> <paragraph num="(viii)"> <text>Drama;</text> </paragraph> <paragraph num="(ix)"> <text>Dance;</text> </paragraph> <paragraph num="(x)"> <text>Art;</text> </paragraph> <paragraph num="(xi)"> <text>A craft;</text> </paragraph> <paragraph num="(xii)"> <text>Except if for credit and taught by a certified teacher, a subject matter enrichment program;</text> </paragraph> <paragraph num="(xiii)"> <text>A specialized activity; or</text> </paragraph> <paragraph num="(xiv)"> <text>Instruction or skill development in an activity listed in §B(29)(b)(i)—(xiii) and (30) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Residential camp” means a youth camp operating at a facility or campsite at which a camper either lives apart or intends to live apart from the camper's relatives, parents, or legal guardians for at least 5 consecutive days.</text> </paragraph> <paragraph num="(31)"> <text>Routine Activity.</text> <paragraph num="(a)"> <text>“Routine activity” means any type of activity other than a specialized activity that is conducted for children by a youth camp.</text> </paragraph> <paragraph num="(b)"> <text>“Routine activity” includes:</text> <paragraph num="(i)"> <text>Except for a specialized activity, a recreational activity listed in §B of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Eating;</text> </paragraph> <paragraph num="(iii)"> <text>Sleeping;</text> </paragraph> <paragraph num="(iv)"> <text>Napping;</text> </paragraph> <paragraph num="(v)"> <text>Playing;</text> </paragraph> <paragraph num="(vi)"> <text>Watching a movie or television; or</text> </paragraph> <paragraph num="(vii)"> <text>Similar activity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(33)"> <text>Sensitive Position.</text> <paragraph num="(a)"> <text>“Sensitive position” means a job, role, or function at a youth camp that allows access to a camper;</text> </paragraph> <paragraph num="(b)"> <text>“Sensitive position” includes, but is not limited to an:</text> <paragraph num="(i)"> <text>Employee;</text> </paragraph> <paragraph num="(ii)"> <text>Volunteer;</text> </paragraph> <paragraph num="(iii)"> <text>Owner; or</text> </paragraph> <paragraph num="(iv)"> <text>Operator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Specialized activity” means:</text> <paragraph num="(a)"> <text>An adventure camp activity or program;</text> </paragraph> <paragraph num="(b)"> <text>An aquatic program;</text> </paragraph> <paragraph num="(c)"> <text>Archery;</text> </paragraph> <paragraph num="(d)"> <text>Artistic gymnastics;</text> </paragraph> <paragraph num="(e)"> <text>Firearms control;</text> </paragraph> <paragraph num="(f)"> <text>Hang gliding;</text> </paragraph> <paragraph num="(g)"> <text>High ropes;</text> </paragraph> <paragraph num="(h)"> <text>Horseback riding;</text> </paragraph> <paragraph num="(i)"> <text>Motorized vehicle activities;</text> </paragraph> <paragraph num="(j)"> <text>Rappelling;</text> </paragraph> <paragraph num="(k)"> <text>Riflery;</text> </paragraph> <paragraph num="(l)"> <text>Road cycling;</text> </paragraph> <paragraph num="(m)"> <text>Rock climbing;</text> </paragraph> <paragraph num="(n)"> <text>Skiing; and</text> </paragraph> <paragraph num="(o)"> <text>Spelunking.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Substantial outdoor recreational component” means that 25 percent or more of a camper's time at camp is spent in outside recreational activities.</text> </paragraph> <paragraph num="(36)"> <text>“Travel camp” means a residential camp that:</text> <paragraph num="(a)"> <text>Operates for at least 5 consecutive days; and</text> </paragraph> <paragraph num="(b)"> <text>Provides for campers to use motorized transportation to move as a group to a site or among sites for experiences in different environments.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Trip camp” means a residential camp:</text> <paragraph num="(a)"> <text>That operates for at least 5 consecutive days; and</text> </paragraph> <paragraph num="(b)"> <text>In which a group of campers moves from one site to another under their own power or by transportation that permits individual guidance of a vehicle or animal.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Unit” means a board, department, agency, or other component of a county or a municipal corporation as defined by Article 23A, §9, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(39)"> <text>“Water safety rescuer” means an individual who is certified by a national organization and the certification substantiates that the individual:</text> <paragraph num="(a)"> <text>Is proficient and knowledgeable in water rescue techniques and safety procedures appropriate to the activity offered; and</text> </paragraph> <paragraph num="(b)"> <text>Demonstrates appropriate skills for safe water rescue.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>Youth Camp.</text> <paragraph num="(a)"> <text>“Youth camp” means a day camp, residential camp, travel camp, or trip camp that:</text> <paragraph num="(i)"> <text>During a calendar year, accommodates seven or more campers who are unrelated to the youth camp operator;</text> </paragraph> <paragraph num="(ii)"> <text>Provides primarily recreational activities or has a substantial outdoor recreational component;</text> </paragraph> <paragraph num="(iii)"> <text>Has permanent buildings, temporary buildings, or no buildings; and</text> </paragraph> <paragraph num="(iv)"> <text>Operates on owned private property, owned private facilities, leased private property, leased private facilities, public property, or public facilities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Youth camp” includes a program that operates:</text> <paragraph num="(i)"> <text>At a camp premises before, after, or before and after the camp program; and</text> </paragraph> <paragraph num="(ii)"> <text>Before, after, or before and after a school term.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Youth camp” does not include:</text> <paragraph num="(i)"> <text>A child care center as defined by COMAR 13A.16.01;</text> </paragraph> <paragraph num="(ii)"> <text>A child care program as defined by COMAR 13A.17.01;</text> </paragraph> <paragraph num="(iii)"> <text>A family child care home as defined by COMAR 13A.15.01;</text> </paragraph> <paragraph num="(iv)"> <text>A program that operates before, after, or before and after a public or nonpublic school's daily session;</text> </paragraph> <paragraph num="(v)"> <text>A program that operates before, after, or before and after a child care program’s daily session as set forth in §B(39)(c)(i)—(iii) of this regulation;</text> </paragraph> <paragraph num="(vi)"> <text>An instructional program in a specialized activity operated for 2 hours or less daily;</text> </paragraph> <paragraph num="(vii)"> <text>A competitive activity sponsored by a sports league or the United States Pony Clubs, Inc.;</text> </paragraph> <paragraph num="(viii)"> <text>A summer school program when the curriculum is offered for academic credit and is taught by a Maryland State Department of Education certified teacher or a teacher qualified under COMAR 13A.09.09;</text> </paragraph> <paragraph num="(ix)"> <text>A day care or child care program that has as its primary purpose the custodial care of children;</text> </paragraph> <paragraph num="(x)"> <text>A program that enrolls a child younger than 3-1/2 years old; or</text> </paragraph> <paragraph num="(xi)"> <text>A recreational activity or program where each child's parent or legal guardian is present throughout the duration of the activity or program, participates in the activity or program, and oversees the activities of the child.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(41)"> <text>“Youth Camp Safety Advisory Council” means an 11 member body that:</text> <paragraph num="(a)"> <text>Advises and assists the Department in developing regulations for camps; and</text> </paragraph> <paragraph num="(b)"> <text>Reports annually to the Secretary on:</text> <paragraph num="(i)"> <text>The number of youth camps;</text> </paragraph> <paragraph num="(ii)"> <text>The number of camps in each county;</text> </paragraph> <paragraph num="(iii)"> <text>The number of campers; and</text> </paragraph> <paragraph num="(iv)"> <text>Any other pertinent information.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Local Government Health and Safety Standards."> <paragraph num="A."> <text>Subject to the provisions of §B of this regulation, each unit of local government shall:</text> <paragraph num="(1)"> <text>Adopt health and safety standards pertaining to the operation of youth camps; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Department documentation that verifies that the unit of local government maintains standards that are at least as protective as those required by this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each unit of local government or the Maryland-National Capital Park and Planning Commission that directs or operates a program or activity under Regulation .01B of this chapter shall certify to the Department, in writing on a form prescribed by the Department, on or before April 1 of each year, that all of those programs or activities operated by the unit comply with:</text> <paragraph num="(1)"> <text>Applicable health and safety standards of the local jurisdiction in which the program or activity is located; and</text> </paragraph> <paragraph num="(2)"> <text>Any State law the enforcement of which has been delegated to local government.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A unit of local government or the Maryland-National Capital Park and Planning Commission that directs or operates a program or activity under Regulation .01B of this chapter may annually elect to comply with Health-General Article, Title 14, Subtitle 4, Annotated Code of Maryland, and this chapter and apply for youth camp certification for that program or activity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="State Agency Program or Activity."> <text>Each agency of the State that directs or operates a program or activity that is not exempt under Regulation .01C of this chapter shall annually certify to the Department, in writing on a form prescribed by the Department on or before April 1 of each year, that each program or activity operated by the State agency complies with Health-General Article, Title 14, Subtitle 4, Annotated Code of Maryland, and this chapter.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Random Inspections, Complaints, and Violations."> <text>The Department shall:</text> <paragraph num="A."> <text>Conduct inspections of:</text> <paragraph num="(1)"> <text>A random 5 percent sample of programs or activities described under Regulations .03 and .04 of this chapter to ensure that each program or activity is in compliance with all applicable health and safety laws and standards; and</text> </paragraph> <paragraph num="(2)"> <text>Any program or activity about which a complaint has been filed; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Advise the unit of local government or State agency of any significant violation of Maryland regulations that would adversely impact the health or safety of children participating in a program or activity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Annual Report and Self-Assessment."> <paragraph num="A."> <text>An operator of a program or activity that complies with Regulation .03 or .04 of this chapter and an operator of a youth camp shall submit an annual report, on a form prescribed by the Department, within 4 weeks of the end of the program, activity, or camp to the Department stating:</text> <paragraph num="(1)"> <text>The actual camper days, that is, the sum total of the actual number of campers who attended camp each day during a camp season;</text> </paragraph> <paragraph num="(2)"> <text>The number of injuries and illnesses that required an operator to submit a report to the Department under COMAR 10.16.07.06; and</text> </paragraph> <paragraph num="(3)"> <text>Other pertinent information requested by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An operator of a camp that paid the reduced fee for a camp in good standing as set forth in COMAR 10.01.17.02B(2) shall:</text> <paragraph num="(1)"> <text>Complete a self-assessment on a form prescribed by the Department by the end of the first week of camp operation each year; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the same form to the Department within 4 weeks of the end of the camp.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Certification or Letter of Compliance."> <paragraph num="A."> <text>An operator of a youth camp shall obtain a youth camp certificate or letter of compliance issued by the Department, which allows the operator to:</text> <paragraph num="(1)"> <text>Operate the youth camp during the period specified on the certificate or letter of compliance; and</text> </paragraph> <paragraph num="(2)"> <text>Provide a specialized activity at a specific location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An operator may not:</text> <paragraph num="(1)"> <text>Operate a youth camp as defined by this chapter and Health-General Article, §14-401, Annotated Code of Maryland, unless the operator has obtained a youth camp certificate or letter of compliance from the Department;</text> </paragraph> <paragraph num="(2)"> <text>Operate a youth camp except during the period of time specified on the certificate, the letter of compliance, or an amendment letter from the Department;</text> </paragraph> <paragraph num="(3)"> <text>Provide a specialized activity that is not specified on the certificate, the letter of compliance, or an amendment letter from the Department; and</text> </paragraph> <paragraph num="(4)"> <text>Provide a specialized activity at a location that is not approved by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A certificate or letter of compliance may not be transferred from:</text> <paragraph num="(1)"> <text>One person to another person;</text> </paragraph> <paragraph num="(2)"> <text>One location to another location; or</text> </paragraph> <paragraph num="(3)"> <text>One youth camp to another youth camp.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Application Procedures and Fees."> <paragraph num="A."> <text>For a camp that was not issued a certificate or a letter of compliance by the Department in the previous calendar year, an operator shall:</text> <paragraph num="(1)"> <text>Apply for a certificate or, in the case of an operator of a youth camp directed or operated by a bona fide religious organization, a certificate or letter of compliance, on a form prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §§D and E of this regulation, pay to the Department the fee as set forth in COMAR 10.01.17.02 at the time of application; and</text> </paragraph> <paragraph num="(3)"> <text>Submit documentation that verifies compliance with or capability of compliance with:</text> <paragraph num="(a)"> <text>Construction or alteration of a camp facility as specified in Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Personnel administrator’s criminal background investigation as specified in Regulation .21A of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Health and medication requirements as specified in Regulation .22 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Emergency procedures as specified in Regulation .34A of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Child abuse prevention and reporting procedures as specified in Regulation .35B of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Water supply as specified in Regulation .36B(1) — (2), C, or D of this chapter;</text> </paragraph> <paragraph num="(g)"> <text>Sewage disposal as specified in Regulation .37A(1) — (2), B, C, or D of this chapter;</text> </paragraph> <paragraph num="(h)"> <text>Bathing and hand washing as specified in Regulation .39B of this chapter;</text> </paragraph> <paragraph num="(i)"> <text>Food service as specified in Regulation.42A(1) or B of this chapter;</text> </paragraph> <paragraph num="(j)"> <text>Fire and electrical code safety as specified in Regulation .46A or B of this chapter;</text> </paragraph> <paragraph num="(k)"> <text>Aquatic programs as specified in Regulation .47A, C, and F(7) — (9) of this chapter;</text> </paragraph> <paragraph num="(l)"> <text>Marksmanship as specified in Regulation .48E of this chapter;</text> </paragraph> <paragraph num="(m)"> <text>Archery as specified in Regulation .49D of this chapter;</text> </paragraph> <paragraph num="(n)"> <text>Horseback riding as specified in Regulation .50C of this chapter; and</text> </paragraph> <paragraph num="(o)"> <text>Specialized activities, trips, transportation, and supervision as specified in Regulations .51 — .54 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For a camp that was issued a certificate or a letter of compliance by the Department in the previous calendar year and wishes to renew its certificate or letter of compliance for another year, an operator shall:</text> <paragraph num="(1)"> <text>Apply for a certificate or, in the case of an operator of a youth camp directed or operated by a bona fide religious organization, a certificate or letter of compliance, on a form prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §§D and E of this regulation, pay to the Department the required fee as set forth in COMAR 10.01.17.02 at the time of application;</text> </paragraph> <paragraph num="(3)"> <text>When a new specialized activity or a new location for a specialized activity is added to the camp’s program, submit documentation that verifies compliance with Regulations .47 — .52 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>When a camp changes location, submit documentation that verifies compliance with:</text> <paragraph num="(a)"> <text>Construction or alteration of a camp facility as specified in Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Water supply as specified in Regulation .36B(1) — (2), C, or D of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Sewage disposal as specified in Regulation .37A(1) — (2), B, C, or D of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Food service as specified in Regulation .42 of this chapter; and</text> </paragraph> <paragraph num="(e)"> <text>Fire and electrical code safety as specified in Regulation .46A or B of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Except for a unit of local government, the Maryland-National Capital Park and Planning Commission, an agency of the State, and as provided in §E of this regulation:</text> <paragraph num="(1)"> <text>An operator of multiple camps at separate sites shall apply for a separate certificate and pay a separate fee for each camp site; and</text> </paragraph> <paragraph num="(2)"> <text>When multiple operators of camps are using the same site, each operator shall:</text> <paragraph num="(a)"> <text>Apply for a separate certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Pay a separate fee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A unit of local government, the Maryland-National Capital Park and Planning Commission, or an agency of the State may annually opt to apply for only one certificate on a form prescribed by the Department and pay only one fee for all programs or activities directed or operated.</text> </paragraph> <paragraph num="E."> <text>When a camp is accredited in accordance with Regulation .19 of this chapter:</text> <paragraph num="(1)"> <text>The operator shall apply for a certificate on a form prescribed by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>The Department may not charge the operator a fee.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An operator of a camp that was not issued a certificate or a letter of compliance by the Department in the previous calendar year shall, at least 60 days before the proposed opening date:</text> <paragraph num="(1)"> <text>Submit the completed application on the prescribed form;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §E of this regulation, pay the required fee; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the required compliance documentation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An operator of a camp that was issued a certificate or a letter of compliance by the Department in the previous calendar year shall, at least 30 calendar days before the proposed opening date:</text> <paragraph num="(1)"> <text>Submit the completed renewal application on the prescribed form;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §E of this regulation, pay the required fee;</text> </paragraph> <paragraph num="(3)"> <text>Pay any fee owed in accordance with §H of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Submit the required compliance documentation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Payment of Fee Difference Owed.</text> <paragraph num="(1)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Calculate a fee difference, that is, the difference between the fee paid at the time of application and the fee owed, based on information reported by a camp operator in the annual report for the past calendar year as required by Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Notify a camp operator of any fee owed to the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 2 weeks following receipt of the notice from the Department, the camp operator shall pay the fee owed to the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Inspections."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Monitor a youth camp for compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inspect the camp at least every fourth year or as necessary for the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Right to Inspect.</text> <paragraph num="(1)"> <text>The Department may enter, at reasonable times, the property of a youth camp for the purposes of inspecting, monitoring, and verifying information relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A person may not deny or interfere with the Department's entry into a youth camp under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An operator shall permit a representative of the Department to examine and copy records of the youth camp to verify information relative to the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Report of Inspection. During a camp inspection, the Department shall:</text> <paragraph num="(1)"> <text>Record the inspection results on an inspection form prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Identify on the inspection form the conditions found that violate the provisions of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Notify the camp operator on the inspection form to correct violations by a specific date; and</text> </paragraph> <paragraph num="(4)"> <text>Provide one copy of the inspection report to the camp director.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The completed inspection report is a public document that is available for public disclosure in accordance with State Government Article, §§10-611 — 10-628, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Time Period for Correction of Violations."> <paragraph num="A."> <text>An operator shall correct a violation:</text> <paragraph num="(1)"> <text>Immediately, if it creates an imminent and substantial danger to a camper; and</text> </paragraph> <paragraph num="(2)"> <text>Within the period of time specified by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may modify a specified time limit of correction when a written schedule of compliance submitted by the camp operator assures that:</text> <paragraph num="(1)"> <text>The correction will be made within a mutually agreeable amount of time; and</text> </paragraph> <paragraph num="(2)"> <text>No imminent and substantial danger to a camper exists without the correction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Variances."> <paragraph num="A."> <text>An operator may apply, in writing, to the Department for a variance of a requirement under this chapter, specifying:</text> <paragraph num="(1)"> <text>The affected regulation;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the request;</text> </paragraph> <paragraph num="(3)"> <text>The name and address of the applicant;</text> </paragraph> <paragraph num="(4)"> <text>The name and location of the camp; and</text> </paragraph> <paragraph num="(5)"> <text>That the requirement is met by an alternative that complies with the intent of the regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may grant a variance of a requirement of this chapter if the:</text> <paragraph num="(1)"> <text>Operator applies for a variance of a requirement in accordance with §A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Campers' health, safety, and well-being are not compromised if the variance is granted.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Grant a variance for a specific time period; and</text> </paragraph> <paragraph num="(2)"> <text>Specify the terms of the variance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When the Department grants a variance for a requirement and the operator complies with the terms of the variance as specified by the Department, the Department shall consider the camp to be in compliance with the applicable regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Issuance of a Certificate, Letter of Compliance, or Acceptance Letter."> <paragraph num="A."> <text>Certificate or Letter of Compliance.</text> <paragraph num="(1)"> <text>The Department shall issue a nontransferable certificate or letter of compliance in accordance with the information provided on the application to a camp that meets the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Except for a camp that applies under Regulation .08A, when a camp does not meet all the requirements of this chapter, the Department may issue a nontransferable certificate or letter of compliance in accordance with the information provided on the application if:</text> <paragraph num="(a)"> <text>The Department approves a written schedule of compliance submitted by the camp operator that assures that corrections that will bring the camp into compliance with the requirements of this chapter will be made within a mutually agreed upon limited time; and</text> </paragraph> <paragraph num="(b)"> <text>There exists no imminent and substantial danger to a camper by the camp's not being in total compliance with the requirements of the chapter for the limited time.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Acceptance Letter for a Unit of Local Government or State Agency. The Department shall issue an acceptance letter to:</text> <paragraph num="(1)"> <text>A unit of local government or the Maryland-National Capital Park and Planning Commission that complies with Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>An agency of the State that complies with Regulation .04 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Posting of Certificate, Letter of Compliance, or Acceptance Letter."> <text>An operator shall:</text> <paragraph num="A."> <text>Post a certificate, letter of compliance, or acceptance letter in a conspicuous place on the premises; or</text> </paragraph> <paragraph num="B."> <text>For a primitive, travel, or trip camp, have the certificate, letter of compliance, or acceptance letter available upon request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Denial of a Certificate or Letter of Compliance."> <paragraph num="A."> <text>The Department may deny an application for a certificate or a letter of compliance, setting forth in writing the reason or reasons for the denial, if the operator:</text> <paragraph num="(1)"> <text>Fails to:</text> <paragraph num="(a)"> <text>Correct a violation within the specified time period;</text> </paragraph> <paragraph num="(b)"> <text>Comply with an approved written schedule of compliance;</text> </paragraph> <paragraph num="(c)"> <text>Correct immediately a violation that the Department has indicated is an imminent and substantial danger to a camper;</text> </paragraph> <paragraph num="(d)"> <text>Correct an outstanding violation from a previous certification or letter of compliance period;</text> </paragraph> <paragraph num="(e)"> <text>File an annual report in accordance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Pay a fee owed as set forth in Regulation .08H of this chapter; or</text> </paragraph> <paragraph num="(g)"> <text>If applicable, file a self-assessment in accordance with Regulation .06 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively obtains or attempts to obtain a certificate or letter of compliance;</text> </paragraph> <paragraph num="(3)"> <text>Fraudulently or deceptively uses a certificate or letter of compliance;</text> </paragraph> <paragraph num="(4)"> <text>Violates a provision of the Maryland Youth Camp Act, Health-General Article, §§14-401 — 14-411, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(5)"> <text>Violates a provision of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall deny an application for a certificate or a letter of compliance in writing, setting forth the reason or reasons for the denial, if the operator fails within the time period specified by the Department to correct a violation of:</text> <paragraph num="(1)"> <text>Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Regulation .21A(2) of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Regulation .22 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Regulation .34 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Regulation .35 of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Regulation .36A and B(1) — (2), C, or D of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Regulation .37A(1) — (2), B, C, or D of this chapter;</text> </paragraph> <paragraph num="(9)"> <text>Regulation .39A(2) — (4) and (8)(c) and B of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Regulation .42 of this chapter;</text> </paragraph> <paragraph num="(11)"> <text>Regulation .46A or B of this chapter; and</text> </paragraph> <paragraph num="(12)"> <text>Regulations .47 — .54 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may deny an application for a certificate or letter of compliance if the health, safety, or welfare of a camper at the camp is or has been threatened.</text> </paragraph> <paragraph num="D."> <text>The Department shall give the camp operator:</text> <paragraph num="(1)"> <text>Written notice of the denial of the certificate or letter of compliance;</text> </paragraph> <paragraph num="(2)"> <text>The reasons for the denial; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with Regulation .17 of this chapter, an opportunity for a hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Suspension or Revocation of a Certificate or Letter of Compliance."> <paragraph num="A."> <text>The Department may suspend or revoke a certificate or letter of compliance if the camp operator:</text> <paragraph num="(1)"> <text>Fails to correct any violation within the specified time period;</text> </paragraph> <paragraph num="(2)"> <text>Fails to comply with an approved written schedule of compliance;</text> </paragraph> <paragraph num="(3)"> <text>Fraudulently or deceptively obtains or attempts to obtain a certificate or letter of compliance;</text> </paragraph> <paragraph num="(4)"> <text>Fraudulently or deceptively uses a certificate or letter of compliance;</text> </paragraph> <paragraph num="(5)"> <text>Violates any provision of the Maryland Youth Camp Act, Health-General Article, §§14-401 — 14-411, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Violates any provision of this chapter; or</text> </paragraph> <paragraph num="(7)"> <text>Fails to correct a situation that threatens the health, safety, or welfare of a camper at the camp.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall suspend or revoke a certificate or letter of compliance if the operator fails within the time period specified by the Department to correct a violation of:</text> <paragraph num="(1)"> <text>Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Regulation .21 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Regulation .22 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Regulation .34 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Regulation .35 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Regulation .36A and B(1) — (2), C, or D of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Regulation .37A(1) — (2), B, C, or D of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Regulation .39A(2) — (4) and (8)(c) and B of this chapter;</text> </paragraph> <paragraph num="(9)"> <text>Regulation .42 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Regulation .46 of this chapter; and</text> </paragraph> <paragraph num="(11)"> <text>Regulations .47 — .54 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may summarily suspend or revoke a certificate or letter of compliance if the Department determines upon inspection of the camp that an imminent threat to the health, safety, or welfare of a camper exists.</text> </paragraph> <paragraph num="D."> <text>The Department shall give the camp operator:</text> <paragraph num="(1)"> <text>Written notice of the suspension or revocation of the certificate or letter of compliance;</text> </paragraph> <paragraph num="(2)"> <text>The reasons for the suspension or revocation; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with Regulation .17 of this chapter, an opportunity for a hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Orders."> <paragraph num="A."> <text>When inspection of a youth camp as set forth in Regulation .09 of this chapter reveals a health or safety violation of this chapter, the Department may issue an order to abate the violation.</text> </paragraph> <paragraph num="B."> <text>When the Department issues an order to abate a violation to a youth camp, the Department shall give the operator an opportunity for a hearing in accordance with Regulation .17 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Opportunity for a Hearing."> <paragraph num="A."> <text>Except as otherwise provided in the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, or in this regulation, before the Department takes any final action to deny, suspend, or revoke a certificate or letter of compliance or enforce an order to abate a violation, the Department shall give the person against whom the action is contemplated an opportunity for a hearing.</text> </paragraph> <paragraph num="B."> <text>A person shall request a hearing, if a hearing is desired, by submitting to the Department a written request for a hearing.</text> </paragraph> <paragraph num="C."> <text>To preserve the right to a hearing, a person shall submit the written request within 10 calendar days of the receipt of the denial, suspension, or revocation notice or an order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Prohibitions to Operate."> <paragraph num="A."> <text>A person whose certificate or letter of compliance is suspended:</text> <paragraph num="(1)"> <text>Shall cease operation; and</text> </paragraph> <paragraph num="(2)"> <text>May not resume operation until:</text> <paragraph num="(a)"> <text>An inspection shows that the condition or conditions responsible for the suspension or order no longer exist; and</text> </paragraph> <paragraph num="(b)"> <text>The Department reinstates the certificate or letter of compliance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A person whose application for a certificate or letter of compliance is denied:</text> <paragraph num="(1)"> <text>May not start operation; or</text> </paragraph> <paragraph num="(2)"> <text>Shall cease operation and may not start or resume operation until:</text> <paragraph num="(a)"> <text>A new application is submitted in accordance with Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>An inspection shows that the condition or conditions responsible for the denial or revocation no longer exist; and</text> </paragraph> <paragraph num="(c)"> <text>The Department issues a certificate or letter of compliance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may take appropriate steps to ensure that the camp operator ceases the operation of the youth camp pursuant to §§A and B of this regulation by:</text> <paragraph num="(1)"> <text>Taking and keeping physical possession of the certificate or letter of compliance until the certificate or letter of compliance is reinstated;</text> </paragraph> <paragraph num="(2)"> <text>Posting signs at the entrance of the camp stating that the certificate or letter of compliance to operate a camp has been denied, suspended, or revoked by the Department; or</text> </paragraph> <paragraph num="(3)"> <text>Taking another measure within the law that will adequately ensure that the youth camp does not operate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When inspection of a youth camp by the Department reveals that there is an imminent and substantial danger to a camper, the Department may seek an injunction to prohibit operation of the camp.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Alternative Accreditation."> <paragraph num="A."> <text>Alternative Accreditation Organization.</text> <paragraph num="(1)"> <text>A person seeking the Department's approval for alternative accreditation shall:</text> <paragraph num="(a)"> <text>Apply to the Department for approval of the alternative accreditation; and</text> </paragraph> <paragraph num="(b)"> <text>Submit to the Department documentation that verifies that the accreditation organization:</text> <paragraph num="(i)"> <text>Maintains accreditation standards that provide the same level of health and safety protection for the campers as required by this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Monitors for and ascertains complete compliance with its standards annually;</text> </paragraph> <paragraph num="(iii)"> <text>Periodically assesses the reliability of the monitoring process;</text> </paragraph> <paragraph num="(iv)"> <text>Records the results of the monitoring visit on a defined form;</text> </paragraph> <paragraph num="(v)"> <text>Identifies conditions that could adversely affect the health or safety of the campers;</text> </paragraph> <paragraph num="(vi)"> <text>Notifies the camp operator to correct deficiencies by a specific date;</text> </paragraph> <paragraph num="(vii)"> <text>Provides one copy of the monitoring report to the person in charge of the youth camp; and</text> </paragraph> <paragraph num="(viii)"> <text>Provides the accreditation organization the original monitoring report and the Department a copy of the monitoring report.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a camp is accredited by an alternative accreditation approved by the Department and the accreditation organization suspends, revokes, or discontinues the youth camp's accreditation, the accreditation organization shall notify the Department of the suspension, revocation, or reasons to discontinue camp:</text> <paragraph num="(a)"> <text>By telephone within 24 hours; and</text> </paragraph> <paragraph num="(b)"> <text>In writing within 3 calendar days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department:</text> <paragraph num="(1)"> <text>Shall review the alternate accreditation proposal submitted by the camping organization within 60 calendar days from receipt of the documentation;</text> </paragraph> <paragraph num="(2)"> <text>Shall accept alternative accreditation as fulfilling the requirements of this chapter when the alternative accreditation:</text> <paragraph num="(a)"> <text>Complies with §A of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Is approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>May suspend, deny, or revoke approval for the alternative accreditation when the accreditation organization fails to comply with §A of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Shall give the person whose alternative accreditation is suspended, denied, or revoked:</text> <paragraph num="(a)"> <text>Written notice of the suspension, denial, or revocation of approval for the alternative accreditation;</text> </paragraph> <paragraph num="(b)"> <text>The reasons for the suspension, denial, or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>An opportunity for a hearing in accordance with Regulation .17 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>May inspect a camp that is accredited by an accreditation organization approved by the Department, according to Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>May investigate a complaint received about the camp;</text> </paragraph> <paragraph num="(7)"> <text>May deny, suspend, or revoke the accredited youth camp's certificate or letter of compliance; and</text> </paragraph> <paragraph num="(8)"> <text>May issue an order to abate a violation or an order to cease operation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The camp operator shall:</text> <paragraph num="(1)"> <text>Submit:</text> <paragraph num="(a)"> <text>An application as required in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>With the application, documentation of the camp's current accreditation from the accreditation organization that is approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Obtain a youth camp certificate or letter of compliance issued by the Department as required in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>When a camp is accredited by an alternative accreditation approved by the Department and the youth camp's accreditation is suspended, revoked, or discontinued by the accreditation organization, notify the Department of the suspension, revocation, or reasons to discontinue camp:</text> <paragraph num="(a)"> <text>By telephone within 24 hours; and</text> </paragraph> <paragraph num="(b)"> <text>In writing within 3 calendar days;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Close a camp:</text> <paragraph num="(a)"> <text>Whose accreditation from an accreditation organization approved by the Department is suspended, revoked, or discontinued; and</text> </paragraph> <paragraph num="(b)"> <text>Whose certificate or letter of compliance from the Department is denied, suspended, or revoked; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the operator wishes to reopen the camp, apply for and obtain a certificate or letter of compliance in accordance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Constructing, Remodeling, Enlarging, Converting, or Reducing Facilities."> <paragraph num="A."> <text>Except for facilities that are used for other purposes where the proposed changes do not affect the operation of the youth camp according to the requirements of this chapter, an operator shall notify the Department, in writing, before:</text> <paragraph num="(1)"> <text>Constructing, remodeling, or enlarging a youth camp;</text> </paragraph> <paragraph num="(2)"> <text>Converting a property for use as a youth camp; or</text> </paragraph> <paragraph num="(3)"> <text>Reducing or eliminating facilities at a youth camp.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure that:</text> <paragraph num="(1)"> <text>The alterations comply with the requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Applicable local approvals required under law, regulation, and local ordinance are obtained before using the premises as a youth camp, including local:</text> <paragraph num="(a)"> <text>Zoning approval;</text> </paragraph> <paragraph num="(b)"> <text>Building approval;</text> </paragraph> <paragraph num="(c)"> <text>Fire safety approval;</text> </paragraph> <paragraph num="(d)"> <text>Electrical approval;</text> </paragraph> <paragraph num="(e)"> <text>Plumbing approval; and</text> </paragraph> <paragraph num="(f)"> <text>Health department approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall inspect the youth camp upon completion of the work for the purpose of monitoring compliance with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Criminal Background Investigations."> <paragraph num="A."> <text>An operator shall:</text> <paragraph num="(1)"> <text>Ensure that a person serving as a personnel administrator has applied for:</text> <paragraph num="(a)"> <text>A national and State criminal history records check through the Department pursuant to Health General Article, §14-403.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>A background clearance request from Child Protective Services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have on file and available for inspection for any person in a sensitive position:</text> <paragraph num="(a)"> <text>Documentation from the Department of a completed national and State criminal history records check through the Maryland Department of Public Safety and Correctional Services; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation of a response from Child Protective Services indicating the status of the background clearance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensure that before the camp operates, the Department has on file for the personnel administrator a:</text> <paragraph num="(a)"> <text>Completed national and State criminal history records check through the Maryland Department of Public Safety and Correctional Services; and</text> </paragraph> <paragraph num="(b)"> <text>Response from Child Protective Services indicating the status of the background clearance; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Notify the Department, in writing within 10 calendar days, if the personnel administrator changes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon notification that an individual may not serve as the personnel administrator, an operator:</text> <paragraph num="(1)"> <text>Shall terminate the individual from employment or remove from consideration for employment, as applicable; and</text> </paragraph> <paragraph num="(2)"> <text>Unless the individual appeals the decision to the Office of Administrative Hearings and the appeal is concluded in favor of the individual, may not:</text> <paragraph num="(a)"> <text>Reconsider the individual for serving as a personnel administrator;</text> </paragraph> <paragraph num="(b)"> <text>Allow the individual to hold a sensitive position; or</text> </paragraph> <paragraph num="(c)"> <text>Except to exercise parental responsibilities with respect to a related child at camp, allow the individual on the premises of the facility or to have any contact with an unrelated child at camp.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The personnel administrator shall:</text> <paragraph num="(1)"> <text>Ensure that, for an individual in a sensitive position at a camp a:</text> <paragraph num="(a)"> <text>Completed national and State criminal history records check through the Maryland Department of Public Safety and Correctional Services is on file with the employer;</text> </paragraph> <paragraph num="(b)"> <text>Response from Child Protective Services indicating the status of the background clearance is kept on file with the employer once received from Child Protective Services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Determine if the individual may hold a sensitive position at camp according to §§F and G of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Upon determining that an individual may not hold a sensitive position at camp:</text> <paragraph num="(a)"> <text>Terminate the individual from the sensitive position;</text> </paragraph> <paragraph num="(b)"> <text>Not consider the individual for any sensitive position at camp or as a personnel administrator; and</text> </paragraph> <paragraph num="(c)"> <text>Except to exercise parental responsibilities with respect to a related child at camp, not allow the individual on the premises of the facility or to have any contact with an unrelated child at camp.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Determine if the individual may serve as the personnel administrator at camp according to §§F and G of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the individual, camp owner, and camp operator in writing about the:</text> <paragraph num="(a)"> <text>Departments decision that the individual may not serve as the personnel administrator;</text> </paragraph> <paragraph num="(b)"> <text>Basis for that decision;</text> </paragraph> <paragraph num="(c)"> <text>Individual’s right to request reassessment pursuant to §H of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Individual’s right to appeal the decision regarding reassessment to the Department;</text> </paragraph> <paragraph num="(e)"> <text>Specific requirements for submitting an appeal to the Department; and</text> </paragraph> <paragraph num="(f)"> <text>10 calendar day time frame to notify the Department of the new personnel administrator and complete the criminal history records check as required in §A of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Determine if an individual may serve in any sensitive position according to §§F and G of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the individual and personnel administrator in writing within three business days about the:</text> <paragraph num="(a)"> <text>Department’s decision whether the individual may serve in a sensitive position;</text> </paragraph> <paragraph num="(b)"> <text>Basis for that decision;</text> </paragraph> <paragraph num="(c)"> <text>Individual’s rights to request the reassessment pursuant to §G of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Individual’s right to appeal the Department’s decision regarding reassessment; and</text> </paragraph> <paragraph num="(e)"> <text>Specific requirements for submitting an appeal in accordance with Title 10 of the State Government Article.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A youth camp operator may not allow an individual to serve in a sensitive position or as a personnel administrator who, as reported on or after October 1, 2005, has received a conviction, a probation before judgment disposition, a not criminally responsible disposition, or a pending charge for the commission or attempted commission of:</text> <paragraph num="(1)"> <text>A crime involving:</text> <paragraph num="(a)"> <text>A child;</text> </paragraph> <paragraph num="(b)"> <text>Cruelty to animals;</text> </paragraph> <paragraph num="(c)"> <text>Domestic violence; or</text> </paragraph> <paragraph num="(d)"> <text>A weapon or firearm violation of federal or State laws;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A sex offense;</text> </paragraph> <paragraph num="(3)"> <text>A violent crime classified as a felony;</text> </paragraph> <paragraph num="(4)"> <text>Abduction or kidnapping;</text> </paragraph> <paragraph num="(5)"> <text>Abuse of a child or an adult;</text> </paragraph> <paragraph num="(6)"> <text>Confinement of an unattended child;</text> </paragraph> <paragraph num="(7)"> <text>Manufacturing, distributing, or dispensing a controlled dangerous substance;</text> </paragraph> <paragraph num="(8)"> <text>Perjury;</text> </paragraph> <paragraph num="(9)"> <text>Pornography;</text> </paragraph> <paragraph num="(10)"> <text>Possession with intent to manufacture, distribute, or dispense a controlled dangerous substance; or</text> </paragraph> <paragraph num="(11)"> <text>Reckless endangerment.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If, as reported on or after October 1, 2005, an individual has been identified as responsible for child abuse or neglect or received a conviction, a probation before judgment disposition, a not criminally responsible disposition, or a pending charge for the commission or attempted commission of a crime or offense that is not included in §F of this regulation, the Department:</text> <paragraph num="(1)"> <text>Shall assess, on the basis of the following factors, the individual's suitability for a sensitive position or serving as personnel administrator at camp:</text> <paragraph num="(a)"> <text>The position at the camp for which the individual is applying or position which the individual currently holds;</text> </paragraph> <paragraph num="(b)"> <text>The nature and seriousness of the incident, crime, or offense;</text> </paragraph> <paragraph num="(c)"> <text>The period of time that has elapsed since the incident, crime, or offense occurred;</text> </paragraph> <paragraph num="(d)"> <text>The age of the individual at the time the incident, crime, or offense occurred;</text> </paragraph> <paragraph num="(e)"> <text>The individual's probation or parole status, if applicable; and</text> </paragraph> <paragraph num="(f)"> <text>Any other information the camp considers pertinent; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Depending on the results of the assessment, shall permit or prohibit the individual from serving in a sensitive position or as a personnel administrator.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Request for Reassessment.</text> <paragraph num="(1)"> <text>An individual who is prohibited from serving in a sensitive position or as a personnel administrator by the Department pursuant to §§F and G of this regulation may request that the Department conduct a reassessment with respect to the incident, crime, or offense.</text> </paragraph> <paragraph num="(2)"> <text>For a reassessment request to be eligible for consideration:</text> <paragraph num="(a)"> <text>The request shall be in writing and include documentation, such as but not limited to letters of support or evaluation reports pertinent to the incident, crime, or offense; and</text> </paragraph> <paragraph num="(b)"> <text>The individual may not have submitted a reassessment request, whether for the same or a different position, within the previous 12 months.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In order to reach a decision on the request for reassessment, the Department may request additional information from the individual, personnel administrator, camp operator, or any agency or entity cited in connection with the reassessment request.</text> </paragraph> <paragraph num="(4)"> <text>Upon reaching a decision on the request, the Department shall notify the individual, personnel administrator, owner, and director of that decision.</text> </paragraph> <paragraph num="(5)"> <text>The camp operator may not permit the individual to begin or to resume serving in a sensitive position or as personnel administrator until the Department has notified the operator that the individual is not disqualified.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Health and Medication Requirements"> <text>An operator shall ensure that a camp complies with COMAR 10.16.07.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="— .33 Repealed." /> <regulation prefix="Regulation" num=".34" heading="Emergency Procedures."> <paragraph num="A."> <text>An operator shall prepare and implement a written emergency plan that includes procedures for the camp staff members to:</text> <paragraph num="(1)"> <text>Ensure camper safety during natural disasters, severe weather, and other emergencies;</text> </paragraph> <paragraph num="(2)"> <text>Evacuate campers from the camp;</text> </paragraph> <paragraph num="(3)"> <text>Account for campers and locate a missing camper;</text> </paragraph> <paragraph num="(4)"> <text>Use fire, rescue, police, and 911 services;</text> </paragraph> <paragraph num="(5)"> <text>Ensure emergency transportation;</text> </paragraph> <paragraph num="(6)"> <text>Notify the camper's parent or guardian;</text> </paragraph> <paragraph num="(7)"> <text>Ensure camper safety until the camper's parent, guardian, or parent's or guardian's designee picks up the camper;</text> </paragraph> <paragraph num="(8)"> <text>Monitor for adverse weather conditions; and</text> </paragraph> <paragraph num="(9)"> <text>Meet the requirements of §B(4) — (7) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure that:</text> <paragraph num="(1)"> <text>Not more than 30 calendar days before working at the camp, each staff member or volunteer:</text> <paragraph num="(a)"> <text>Is trained in the emergency plan;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrates knowledge of emergency procedures; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided with the opportunity to discuss the procedures and have any questions answered by a supervisor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation is kept on file that each staff member or volunteer received the training required in §B(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>A staff member or volunteer conducts emergency procedures according to the emergency plan;</text> </paragraph> <paragraph num="(4)"> <text>A telephone or alternate means of communication is provided to:</text> <paragraph num="(a)"> <text>Summon emergency fire and rescue services; and</text> </paragraph> <paragraph num="(b)"> <text>Receive emergency communications;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A drill in the emergency procedures is conducted early in each session and a written record is maintained of the drill;</text> </paragraph> <paragraph num="(6)"> <text>At least one adult staff member and one counselor or assistant counselor are present so that in the event of an emergency:</text> <paragraph num="(a)"> <text>One staff member remains with an injured camper; and</text> </paragraph> <paragraph num="(b)"> <text>The other summons emergency assistance immediately; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>During severe weather, adequate shelter is provided for the campers and camp staff members.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Child Abuse Prevention and Reporting."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>Child abuse allegations or incidents are reported as prescribed in Family Law Article, §§5-704 and 5-705, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>A written child abuse prevention and reporting program is prepared and implemented at the camp that includes procedures for:</text> <paragraph num="(1)"> <text>Educating staff members and volunteers;</text> </paragraph> <paragraph num="(2)"> <text>Reporting child abuse both internally and externally;</text> </paragraph> <paragraph num="(3)"> <text>Screening staff members and volunteers prior to working at camp;</text> </paragraph> <paragraph num="(4)"> <text>Reinforcing the camp’s policies and procedures during camp operation;</text> </paragraph> <paragraph num="(5)"> <text>Evaluating the facilities and grounds;</text> </paragraph> <paragraph num="(6)"> <text>Supervising campers;</text> </paragraph> <paragraph num="(7)"> <text>Educating on appropriate touching;</text> </paragraph> <paragraph num="(8)"> <text>Responding to inappropriate behaviors by staff, volunteers, parents, and campers;</text> </paragraph> <paragraph num="(9)"> <text>Communicating with staff members, volunteers, parents, the Department, and the media;</text> </paragraph> <paragraph num="(10)"> <text>Supporting an alleged victim; and</text> </paragraph> <paragraph num="(11)"> <text>Interacting with an alleged perpetrator;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Not more than 30 calendar days before working at the camp, each staff member or volunteer:</text> <paragraph num="(1)"> <text>Is trained in the child abuse prevention and reporting program required in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates knowledge of the child abuse prevention and reporting procedures; and</text> </paragraph> <paragraph num="(3)"> <text>Is provided with the opportunity to discuss the procedures and have any questions answered by a supervisor; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Documentation is kept on file that each staff member or volunteer received the training required in §C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Water Supply."> <paragraph num="A."> <text>An operator shall ensure that the camp's water supply is:</text> <paragraph num="(1)"> <text>Adequate;</text> </paragraph> <paragraph num="(2)"> <text>Easily accessible to the campers; and</text> </paragraph> <paragraph num="(3)"> <text>Of a safe and sanitary quality.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided in §§C and D of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>The camp's water supply is:</text> <paragraph num="(a)"> <text>From a public or individual water supply system, or connected to a community water system where available;</text> </paragraph> <paragraph num="(b)"> <text>Constructed, protected, operated, and maintained in conformance with:</text> <paragraph num="(i)"> <text>COMAR 26.04.01 and 26.04.04, as evidenced by written documentation from the local health department or the Maryland Department of the Environment as applicable;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 09.20.01, as evidenced by written documentation from the local or State plumbing inspector or a master plumber licensed by the State; and</text> </paragraph> <paragraph num="(iii)"> <text>Applicable local ordinances, as evidenced by written documentation from the local approving authority; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Protected against backflow;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual water supply system:</text> <paragraph num="(a)"> <text>Is capable of supplying a minimum flow and pressure to all fixtures as required by COMAR 09.20.01; and</text> </paragraph> <paragraph num="(b)"> <text>Is installed in accordance with the county master plan for water and sewerage;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pumping and disinfection equipment is housed in a structure that is inaccessible to unauthorized persons; and</text> </paragraph> <paragraph num="(4)"> <text>Hose bibs with threads are equipped with nonremovable back siphonage prevention devices.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An operator may provide written documentation from the building owner that there are no outstanding water supply and plumbing violations for a building used or to be used as a youth camp facility that is:</text> <paragraph num="(1)"> <text>Owned by the State or a local government and used by the public for more than 170 calendar days per year; or</text> </paragraph> <paragraph num="(2)"> <text>Owned and operated as a nonpublic school and used as a school for more than 170 calendar days per year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An operator shall ensure that the water supply at a primitive camp is:</text> <paragraph num="(1)"> <text>Filtered and disinfected; and</text> </paragraph> <paragraph num="(2)"> <text>Free from impurities in amounts sufficient to cause disease or harmful physiological effects.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Sewage Disposal."> <paragraph num="A."> <text>Except as provided in §§B, C, and D of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>A facility for sewage disposal is maintained in good working order and is:</text> <paragraph num="(a)"> <text>Connected to a community sewerage system when a community system is available; or</text> </paragraph> <paragraph num="(b)"> <text>If a community sewerage system is not available, installed, operated, and maintained in compliance with COMAR 26.04.02 and local code requirements;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>As evidenced by written documentation from the local or State plumbing inspector or a master plumber licensed by the State, waste plumbing connections and fixtures are installed and maintained in accordance with:</text> <paragraph num="(a)"> <text>Local plumbing code requirements; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 09.20.01; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The disposal of wastewater from under taps and fountains is by a method that:</text> <paragraph num="(a)"> <text>Prevents stagnant water on the ground surface; and</text> </paragraph> <paragraph num="(b)"> <text>Does not contaminate the ground water.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure that a privy:</text> <paragraph num="(1)"> <text>Is constructed and maintained so that it:</text> <paragraph num="(a)"> <text>Is fly-proof;</text> </paragraph> <paragraph num="(b)"> <text>Is rodent-proof; and</text> </paragraph> <paragraph num="(c)"> <text>Conforms to COMAR 26.04.02 and Environment Article, §9-223(d)(1), Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is maintained in good working order;</text> </paragraph> <paragraph num="(3)"> <text>Is not located closer than 100 feet to a housing unit or a facility where food is prepared or served;</text> </paragraph> <paragraph num="(4)"> <text>Has natural ventilation or a mechanically exhausted vent stack adequate to remove fumes and odors from the vault;</text> </paragraph> <paragraph num="(5)"> <text>Is treated with calcium oxide, also known as lime, to reduce odors and eliminate a fly infestation; and</text> </paragraph> <paragraph num="(6)"> <text>Is emptied:</text> <paragraph num="(a)"> <text>Of solid and liquid contents when the privy is filled to capacity; and</text> </paragraph> <paragraph num="(b)"> <text>In conformance with COMAR 26.04.02 and COMAR 26.04.06.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An operator may provide written documentation from the building owner that there are no outstanding sewage disposal and plumbing violations for a building used or to be used as a youth camp facility that is:</text> <paragraph num="(1)"> <text>Owned by the State or a local government and used by the public more than 170 calendar days per year; or</text> </paragraph> <paragraph num="(2)"> <text>Owned and operated as a nonpublic school and used as a school for more than 170 calendar days per year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An operator shall ensure that a sewage disposal procedure at a primitive camp:</text> <paragraph num="(1)"> <text>Does not pollute the environment;</text> </paragraph> <paragraph num="(2)"> <text>Does not create a nuisance or public health hazard; and</text> </paragraph> <paragraph num="(3)"> <text>Complies with applicable federal, State, and local statutes, regulations, and ordinances.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Toilet Facilities."> <paragraph num="A."> <text>Except as provided in §C of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>Toilet facilities are constructed, located, and maintained to prevent a:</text> <paragraph num="(a)"> <text>Nuisance; or</text> </paragraph> <paragraph num="(b)"> <text>Public health hazard;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For residential camps, one toilet is provided for each 15 campers or fraction of 15 campers;</text> </paragraph> <paragraph num="(3)"> <text>For day camps, one toilet is provided for each 35 campers or fraction of 35 campers;</text> </paragraph> <paragraph num="(4)"> <text>If separate toilet facilities for boys and girls are in the same building, the facilities:</text> <paragraph num="(a)"> <text>Are separated by a solid wall from floor to roof or ceiling; and</text> </paragraph> <paragraph num="(b)"> <text>Have self-closing doors or another means that affords privacy;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If separate toilet facilities are provided for boys and girls, they are distinctly marked “boys” and “girls” in:</text> <paragraph num="(a)"> <text>Universal symbols; or</text> </paragraph> <paragraph num="(b)"> <text>The native language of the campers expected to use the facility;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Toilet tissue on a holder is furnished adjacent to a toilet;</text> </paragraph> <paragraph num="(7)"> <text>A toilet facility has adequate:</text> <paragraph num="(a)"> <text>Mechanical exhaust; or</text> </paragraph> <paragraph num="(b)"> <text>Natural ventilation; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A toilet facility is located within 300 feet of each housing unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An operator may substitute urinals constructed of non-absorbent materials for boys' toilets on the basis of one urinal for one toilet up to a maximum of 1/3 of those facilities required.</text> </paragraph> <paragraph num="C."> <text>Sections A and B of this regulation do not apply to a primitive camp.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Bathing and Hand Washing Facilities."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>Hand washing facilities are located:</text> <paragraph num="(a)"> <text>Within 300 feet of each housing unit; and</text> </paragraph> <paragraph num="(b)"> <text>Adjacent to each toilet or privy site;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except when a camper provides the camper's own soap and towel, a hand washing unit is equipped with:</text> <paragraph num="(a)"> <text>Soap; and</text> </paragraph> <paragraph num="(b)"> <text>A hot air hand drier or disposable towels;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a residential camp, one hand washing unit is provided for every 25 campers or fraction of 25 campers;</text> </paragraph> <paragraph num="(4)"> <text>For a day camp, one hand washing unit is provided for every 35 campers or fraction of 35 campers;</text> </paragraph> <paragraph num="(5)"> <text>A trash container is provided in a lavatory area;</text> </paragraph> <paragraph num="(6)"> <text>For a residential camp, one showerhead is provided for every 15 campers or fraction of 15 campers;</text> </paragraph> <paragraph num="(7)"> <text>Whenever a shower is provided:</text> <paragraph num="(a)"> <text>Shower heads are spaced at least 30 inches apart to provide a minimum of 6 square feet of floor area per unit;</text> </paragraph> <paragraph num="(b)"> <text>A shower wall and ceiling is constructed of solid, nonabsorbent, easily cleanable materials;</text> </paragraph> <paragraph num="(c)"> <text>A shower floor is:</text> <paragraph num="(i)"> <text>Constructed of nonabsorbent, skid resistant, easily cleanable materials; and</text> </paragraph> <paragraph num="(ii)"> <text>Sloped to properly constructed floor drains, with provisions to prevent pooling of water or overflow to adjacent floor areas;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A shower partition or shower curtain is provided to prevent splash from stall-type showers;</text> </paragraph> <paragraph num="(e)"> <text>A soap storage area or nonglass soap dish is provided adjacent to a showerhead;</text> </paragraph> <paragraph num="(f)"> <text>A dry dressing space with clothes hanging facilities is provided at a shower facility;</text> </paragraph> <paragraph num="(g)"> <text>A nonabsorbent wall, extending from the floor to the ceiling or roof, separates facilities for both sexes in the same building;</text> </paragraph> <paragraph num="(h)"> <text>Facilities are plainly designated boys or girls in:</text> <paragraph num="(i)"> <text>Universal symbols; or</text> </paragraph> <paragraph num="(ii)"> <text>The native language of the campers expected to use the facility;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>A shower room is provided with a door or sight barriers to afford privacy; and</text> </paragraph> <paragraph num="(j)"> <text>Hot and cold or tempered water is supplied to a shower; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Whenever hot water is supplied:</text> <paragraph num="(a)"> <text>The hot water temperature is maintained between 90° and 120°F;</text> </paragraph> <paragraph num="(b)"> <text>A water heater is equipped with a:</text> <paragraph num="(i)"> <text>Pressure and temperature relief valve; and</text> </paragraph> <paragraph num="(ii)"> <text>Vacuum relief valve; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Anti-scald protection is provided on a hot water line going to a shower or bathtub.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure that bathing and hand washing at a primitive camp:</text> <paragraph num="(1)"> <text>Are sanitary and promote personal hygiene;</text> </paragraph> <paragraph num="(2)"> <text>Do not create a nuisance or public health hazard;</text> </paragraph> <paragraph num="(3)"> <text>Do not pollute the environment; and</text> </paragraph> <paragraph num="(4)"> <text>Comply with applicable federal, State, and local statutes, regulations, and ordinances.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Sleeping Facilities in Resident Youth Camps."> <text>An operator shall:</text> <paragraph num="A."> <text>Except at a primitive camp, provide a bed, cot, or bunk for each individual;</text> </paragraph> <paragraph num="B."> <text>Ensure that each bed, cot, or bunk has a sturdy frame allowing at least 12 inches of clear space from the floor;</text> </paragraph> <paragraph num="C."> <text>Ensure that each individual at a primitive camp:</text> <paragraph num="(1)"> <text>Is provided with a sleeping bag; or</text> </paragraph> <paragraph num="(2)"> <text>Brings the individual's own sleeping bag;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Provide only clean and sanitary bedding to an individual, when bedding is provided;</text> </paragraph> <paragraph num="E."> <text>Ensure that a clean, disinfected, vermin-free, hole-free mattress, completely covered with a clean sheet or a plastic mattress cover is provided for each individual;</text> </paragraph> <paragraph num="F."> <text>Ensure that a mattress is disinfected annually;</text> </paragraph> <paragraph num="G."> <text>Ensure that where double-deck bunk beds are used the:</text> <paragraph num="(1)"> <text>Clear space above the top of the lower bedding and below the bottom of the upper bunk is a minimum of 27 inches; and</text> </paragraph> <paragraph num="(2)"> <text>Distance from the top of the upper mattress to the ceiling is a minimum of 36 inches; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>Except at a primitive camp, provide at least 30 square feet of floor space per occupant in sleeping areas, including space for aisles between beds.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Tents or Fabric Shelters."> <text>When a tent or fabric shelter is used, an operator shall ensure that:</text> <paragraph num="A."> <text>The occupancy of the tent or fabric shelter does not exceed the manufacturer's recommended capacity; and</text> </paragraph> <paragraph num="B."> <text>The tent or fabric shelter:</text> <paragraph num="(1)"> <text>Is made of fire retardant material;</text> </paragraph> <paragraph num="(2)"> <text>Bears a permanent label which states conspicuously, “WARNING: NO OPEN FLAMES IN OR NEAR THIS TENT OR FABRIC SHELTER”; and</text> </paragraph> <paragraph num="(3)"> <text>Is located at least 10 feet away from a campfire or open flame.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="Food Service."> <paragraph num="A."> <text>An operator shall ensure that:</text> <paragraph num="(1)"> <text>Except as provided in §B of this regulation, a camp complies with all applicable food service statutes and regulations as set forth in Health-General Article, Title 21, Annotated Code of Maryland, and COMAR 10.15.03;</text> </paragraph> <paragraph num="(2)"> <text>A parent or guardian is notified in writing of the camp’s policy on storage of a lunch brought from home; and</text> </paragraph> <paragraph num="(3)"> <text>If a camp permits potentially hazardous food, as defined in COMAR 10.15.03, in a lunch brought from home, the lunch is kept refrigerated at a temperature of 41°F or below.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Primitive Camp. An operator of a primitive camp shall ensure that:</text> <paragraph num="(1)"> <text>Food served is:</text> <paragraph num="(a)"> <text>Wholesome and safe for human consumption;</text> </paragraph> <paragraph num="(b)"> <text>Free from spoilage, filth, or other contamination; and</text> </paragraph> <paragraph num="(c)"> <text>Obtained from sources that comply with all laws relating to food and food labeling;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Transportation, storage, preparation, cooking, and service procedures are implemented to:</text> <paragraph num="(a)"> <text>Protect food and equipment from contamination; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain safe temperatures, as defined in COMAR 10.15.03;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Equipment is provided to transport, store, prepare, cook, and serve food safely;</text> </paragraph> <paragraph num="(4)"> <text>A food-contact surface of equipment used to prepare, store, or serve a potentially hazardous food is cleaned and sanitized:</text> <paragraph num="(a)"> <text>After each use; and</text> </paragraph> <paragraph num="(b)"> <text>If the surface is contaminated;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Hand washing materials are provided;</text> </paragraph> <paragraph num="(6)"> <text>A food handler maintains personal cleanliness during work, including:</text> <paragraph num="(a)"> <text>Washing the food handler's hands:</text> <paragraph num="(i)"> <text>Before starting work;</text> </paragraph> <paragraph num="(ii)"> <text>After using toilet facilities;</text> </paragraph> <paragraph num="(iii)"> <text>Before touching foods; and</text> </paragraph> <paragraph num="(iv)"> <text>As often as required to remove soil and contamination;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Keeping fingernails clean and neatly trimmed; and</text> </paragraph> <paragraph num="(c)"> <text>Keeping outer garments clean; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A food handler uses safe food handling practices during work, including:</text> <paragraph num="(a)"> <text>Keeping the food handler's hands clean when handling food and food-contact surfaces;</text> </paragraph> <paragraph num="(b)"> <text>Wearing a hair net, cap, or other effective hair restraint;</text> </paragraph> <paragraph num="(c)"> <text>Not smoking or using tobacco in any form; and</text> </paragraph> <paragraph num="(d)"> <text>Not working when infected with a disease that is communicable by way of food;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Food storage is provided that:</text> <paragraph num="(a)"> <text>Has effective insulation;</text> </paragraph> <paragraph num="(b)"> <text>Maintains food at safe temperatures during storage, preparation, and transportation;</text> </paragraph> <paragraph num="(c)"> <text>Has a thermometer graduated at 2°F intervals;</text> </paragraph> <paragraph num="(d)"> <text>Maintains cold foods at or below 41°F;</text> </paragraph> <paragraph num="(e)"> <text>Maintains hot foods at or above 135°F; and</text> </paragraph> <paragraph num="(f)"> <text>Maintains frozen foods at or below 0°F;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>If cold food exceeds 50°F before serving, the food is discarded as garbage; and</text> </paragraph> <paragraph num="(10)"> <text>Hot food is:</text> <paragraph num="(a)"> <text>Thoroughly cooked to achieve a safe internal temperature as determined by the use of a metal stem thermometer;</text> </paragraph> <paragraph num="(b)"> <text>Consumed immediately after preparation; and</text> </paragraph> <paragraph num="(c)"> <text>Discarded as garbage if not consumed immediately after preparation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".43" heading="Garbage and Other Refuse."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>Durable containers in good condition are provided for the storage of garbage and other refuse;</text> </paragraph> <paragraph num="B."> <text>Garbage and trash are:</text> <paragraph num="(1)"> <text>Collected as often as necessary to prevent the containers from overflowing; and</text> </paragraph> <paragraph num="(2)"> <text>Disposed of by a system in accordance with State and local laws, regulations, and ordinances; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Containers used outside:</text> <paragraph num="(1)"> <text>Have tight-fitting lids; and</text> </paragraph> <paragraph num="(2)"> <text>Are leak-proof, fly-proof, and rodent-proof.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".44" heading="Insect, Rodent, and Vermin Control."> <text>An operator shall ensure that a facility at the camp is maintained to:</text> <paragraph num="A."> <text>Minimize the entry of insects, rodents, and other vermin into the structures or campsite; and</text> </paragraph> <paragraph num="B."> <text>Eliminate the harborage of insects, rodents, and other vermin.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".45" heading="Rabies Controls."> <text>An operator shall comply with animal vaccination requirements, as set forth in:</text> <paragraph num="A."> <text>Health-General Article, §18-318, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>COMAR 10.06.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".46" heading="Fire and Other Hazards."> <paragraph num="A."> <text>Except for the operator of a primitive camp and as provided in §B of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>A camp is:</text> <paragraph num="(a)"> <text>In compliance with all fire and safety code requirements; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the State or county fire authority;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Buildings within the camp are constructed and maintained in accordance with State and local fire and safety codes; and</text> </paragraph> <paragraph num="(3)"> <text>An electrical system at a camp is:</text> <paragraph num="(a)"> <text>Installed and maintained in compliance with local electrical codes; or</text> </paragraph> <paragraph num="(b)"> <text>In the absence of a local electrical code, safe and inspected for safety by a master electrician licensed by the State, as evidenced by written documentation from the inspecting electrician.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An operator may provide written documentation from the building owner that there are no outstanding electrical and fire safety code violations for a building used or to be used as a youth camp facility that is:</text> <paragraph num="(1)"> <text>Owned by the State or a local government and used by the public for more than 170 calendar days per year; or</text> </paragraph> <paragraph num="(2)"> <text>Owned and operated as a nonpublic school and used as a school for more than 170 calendar days per year.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An operator shall ensure that a:</text> <paragraph num="(1)"> <text>Pesticide, toxic chemical, or hazardous material is:</text> <paragraph num="(a)"> <text>Properly labeled;</text> </paragraph> <paragraph num="(b)"> <text>Stored in a safe manner;</text> </paragraph> <paragraph num="(c)"> <text>Not accessible to a camper; and</text> </paragraph> <paragraph num="(d)"> <text>Used only by a camp staff member;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Camp staff member is trained to use a hazardous material safely before the staff member handles a hazardous material at the camp;</text> </paragraph> <paragraph num="(3)"> <text>Material safety data sheet for a potentially hazardous chemical is available to the camp staff members; and</text> </paragraph> <paragraph num="(4)"> <text>Chemical is handled, used, stored, and disposed of according to the material safety data sheet and all applicable federal, State, and local codes.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An operator shall:</text> <paragraph num="(1)"> <text>Ensure that a camp is maintained to eliminate or minimize a safety hazard such as:</text> <paragraph num="(a)"> <text>Entrapment;</text> </paragraph> <paragraph num="(b)"> <text>Entanglement;</text> </paragraph> <paragraph num="(c)"> <text>Impact with moving equipment or a moving vehicle;</text> </paragraph> <paragraph num="(d)"> <text>Impact from equipment tipover or failure;</text> </paragraph> <paragraph num="(e)"> <text>Contact with hazards such as protrusions, pinch points, sharp edges, or hot surfaces;</text> </paragraph> <paragraph num="(f)"> <text>A water fall;</text> </paragraph> <paragraph num="(g)"> <text>Poisonous snakes, insects, or plants;</text> </paragraph> <paragraph num="(h)"> <text>A natural or man-made hazard specific to the site; or</text> </paragraph> <paragraph num="(i)"> <text>Any other condition or situation that poses a risk of injury to a camper or staff member; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide warning signs or a barrier around a hazard that cannot be eliminated due to a natural condition at the camp.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".47" heading="Specialized Activities: Aquatic Programs."> <paragraph num="A."> <text>For a camp that offers an aquatic program, an operator shall ensure that:</text> <paragraph num="(1)"> <text>During the aquatic activity, a director is present at the camp or, when the activity occurs off the camp premises, at the activity site;</text> </paragraph> <paragraph num="(2)"> <text>A safety plan is developed and implemented:</text> <paragraph num="(a)"> <text>According to Regulation .52 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>That includes procedures for:</text> <paragraph num="(i)"> <text>Evaluating and classifying a camper’s swimming ability and other appropriate aquatic skills before a camper participates in water activities;</text> </paragraph> <paragraph num="(ii)"> <text>Assigning a camper to areas, equipment, facilities, and activities appropriate for the camper’s abilities;</text> </paragraph> <paragraph num="(iii)"> <text>Maintaining water activity equipment and facilities in good working condition;</text> </paragraph> <paragraph num="(iv)"> <text>A safety system to account quickly for all campers during the water activity;</text> </paragraph> <paragraph num="(v)"> <text>Supervision ratios in §C of this regulation;</text> </paragraph> <paragraph num="(vi)"> <text>When natural swimming areas are used, meeting the requirements in §E(2) of this regulation; and</text> </paragraph> <paragraph num="(vii)"> <text>When watercraft activities occur, meeting the requirements of §F of this regulation.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency and First Aid Information and Equipment. At the site of the aquatic program, an operator shall:</text> <paragraph num="(1)"> <text>Post in a conspicuous place, or for a primitive camp have available, a list of emergency procedures and, if a phone is provided, a list of emergency telephone numbers; and</text> </paragraph> <paragraph num="(2)"> <text>Provide first aid and rescue equipment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Swimming. An operator shall ensure that:</text> <paragraph num="(1)"> <text>When swimming instruction is given, an instructor is present and supervising the activity;</text> </paragraph> <paragraph num="(2)"> <text>One lifeguard, with lifeguard certification appropriate for the swimming site, is on duty for each group of 50 campers or fraction of 50 campers in the water;</text> </paragraph> <paragraph num="(3)"> <text>A watcher, who is a staff member or volunteer who is 16 years old or older and is not the individual required in §C(1) or (2) of this regulation, is on duty at pool side observing the campers for each group of 25 campers or a fraction of 25 campers in the water;</text> </paragraph> <paragraph num="(4)"> <text>Two individuals certified in first aid and CPR are on duty at the activity;</text> </paragraph> <paragraph num="(5)"> <text>An additional instructor, lifeguard, counselor, or assistant counselor is on duty if any condition exists that compromises the ability of the staff member to perform the staff member's job duty; and</text> </paragraph> <paragraph num="(6)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or fraction of ten campers participating in the swimming activity;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Pool and Equipment. An operator shall ensure that a swimming pool facility and equipment:</text> <paragraph num="(1)"> <text>Complies with the requirements of COMAR 10.17.01; and</text> </paragraph> <paragraph num="(2)"> <text>Are maintained in good condition.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Natural Diving and Swimming Areas. For a youth camp that uses a natural diving or swimming area, an operator shall:</text> <paragraph num="(1)"> <text>Comply with the requirements of COMAR 26.08.09; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that:</text> <paragraph num="(a)"> <text>A hazard is assessed and eliminated or clearly marked before a camper swims, dives, or bathes at a natural diving or swimming area;</text> </paragraph> <paragraph num="(b)"> <text>A swimmer is not subjected to a dangerous condition such as a strong current, a sharp drop-off, a quicksand bottom, or rough surf;</text> </paragraph> <paragraph num="(c)"> <text>Water is free from dangerous aquatic life;</text> </paragraph> <paragraph num="(d)"> <text>The bottom is free from hazardous debris, sharp stones, and sharp shells;</text> </paragraph> <paragraph num="(e)"> <text>Swimming, diving, and boating areas are clearly marked or roped off; and</text> </paragraph> <paragraph num="(f)"> <text>Diving and swimming programs are conducted at separate times or in separate areas from boating programs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Activities Involving the Use of Watercraft. An operator shall ensure that:</text> <paragraph num="(1)"> <text>A watercraft is equipped with U.S. Coast Guard approved personal flotation devices of Types I, II, or III, as prescribed for the specific type of craft and number and age of occupants;</text> </paragraph> <paragraph num="(2)"> <text>A water skier wears a personal flotation device approved by the U.S. Coast Guard for that particular activity;</text> </paragraph> <paragraph num="(3)"> <text>A watercraft towing a water skier has an observer on board in addition to the driver;</text> </paragraph> <paragraph num="(4)"> <text>An occupant of a watercraft wears a U.S. Coast Guard approved personal flotation device;</text> </paragraph> <paragraph num="(5)"> <text>An individual using a watercraft has been given training in boarding, debarking, and safety procedures for the craft;</text> </paragraph> <paragraph num="(6)"> <text>Except on a river trip when the instructor's supervision is described in a written safety plan, an instructor is within sight and hearing of the watercraft activity;</text> </paragraph> <paragraph num="(7)"> <text>An individual holding certification in first aid and CPR is present at each watercraft activity;</text> </paragraph> <paragraph num="(8)"> <text>One lifeguard or water safety rescuer who has lifeguard or rescuer certification appropriate for the watercraft site and activity is present at each watercraft activity; and</text> </paragraph> <paragraph num="(9)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or fraction of ten campers participating in the watercraft activity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".48" heading="Specialized Activities: Marksmanship Using Rifles and Air Guns."> <paragraph num="A."> <text>Rifle Range. For a camp that offers riflery activities, an operator shall ensure that:</text> <paragraph num="(1)"> <text>The rifle range is located where a camper will not wander into the field of fire while engaged in other camp activities;</text> </paragraph> <paragraph num="(2)"> <text>If possible, the direction of fire is to the north to minimize a shooter being blinded by the sun;</text> </paragraph> <paragraph num="(3)"> <text>A blind approach to the field of fire is fenced, with warning signs posted;</text> </paragraph> <paragraph num="(4)"> <text>The firing line is level from one flank to the other with a minimum of 5 feet between firing points;</text> </paragraph> <paragraph num="(5)"> <text>A ready line is established 10 feet to the rear of the firing points;</text> </paragraph> <paragraph num="(6)"> <text>The rifle range is free of an object that might cause a bounce back or a ricochet; and</text> </paragraph> <paragraph num="(7)"> <text>Except when visibility extends downrange for at least 3,000 feet beyond the targets, a backstop is present that is:</text> <paragraph num="(a)"> <text>A hill that:</text> <paragraph num="(i)"> <text>Has a crest of not less than 30 feet above the level of the firing point;</text> </paragraph> <paragraph num="(ii)"> <text>Is clear of brush for an area at least 100 yards up the slope from the targets or to the crest of the hill;</text> </paragraph> <paragraph num="(iii)"> <text>Has a cut taken out of the face of the hillside immediately behind the targets to provide a perpendicular face to catch the bullets and prevent ricochet;</text> </paragraph> <paragraph num="(iv)"> <text>Has all rocks, glass, and metal removed from the perpendicular cut immediately behind the targets; and</text> </paragraph> <paragraph num="(v)"> <text>Has a nonremovable obstacle covered with at least 6 inches of soil and sodded or seeded to prevent a ricochet; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A wood crib that is:</text> <paragraph num="(i)"> <text>Filled with dry earth or sand; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 10 feet high, 30 inches thick, and 6 feet beyond the end of the targets.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Air Gun Range. An operator shall ensure that an air gun range:</text> <paragraph num="(1)"> <text>Complies with all requirements of §A(1) — (6) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Except when the entire safety fan area of the air gun range is unoccupied, has a backstop that meets all requirements of §A(7) of this regulation or has a backstop that:</text> <paragraph num="(a)"> <text>Is covered with soft material to prevent a ricochet, a bounce back, or a shot from leaving the range area;</text> </paragraph> <paragraph num="(b)"> <text>Has walls or side berms that are covered with soft materials to prevent a ricochet, a bounce back, or a shot from leaving the range area; and</text> </paragraph> <paragraph num="(c)"> <text>Is sufficient to stop or contain the pellets.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>For a camp that offers a riflery or an air gun activity, or both, an operator shall ensure that:</text> <paragraph num="(1)"> <text>A camper is instructed in safe firing range procedures before the camper participates in the activity;</text> </paragraph> <paragraph num="(2)"> <text>Red firing flags are conspicuously displayed when the range is in use;</text> </paragraph> <paragraph num="(3)"> <text>Only an individual ready to fire is on the firing line and anyone waiting to fire remains behind the ready line;</text> </paragraph> <paragraph num="(4)"> <text>An individual stays behind the firing line at all times, except when ordered by the instructor to retrieve targets; and</text> </paragraph> <paragraph num="(5)"> <text>Guns and ammunition are stored separately in a locked storage area.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Riflery and Air Gun Activity Staff Members.</text> <paragraph num="(1)"> <text>An operator shall ensure that:</text> <paragraph num="(a)"> <text>During the riflery or air gun activity, a director is present at the camp or, when the activity occurs off the camp premises, the activity site;</text> </paragraph> <paragraph num="(b)"> <text>An instructor and at least one counselor or assistant counselor to assist are on the range at all times during a firing session; and</text> </paragraph> <paragraph num="(c)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or fraction of ten campers on the firing line.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An instructor shall ensure that:</text> <paragraph num="(a)"> <text>The equipment is clean and in good repair;</text> </paragraph> <paragraph num="(b)"> <text>The equipment is stored safely and secured;</text> </paragraph> <paragraph num="(c)"> <text>The equipment use is controlled by means of a checkout system;</text> </paragraph> <paragraph num="(d)"> <text>Safety glasses are provided for and worn by each shooter and staff member on the firing line; and</text> </paragraph> <paragraph num="(e)"> <text>Except at an air gun activity, ear protection is provided for and worn by each shooter and staff member on the firing line.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Procedures. An operator shall ensure that a safety plan is developed and implemented:</text> <paragraph num="(1)"> <text>According to Regulation .52 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>That includes procedures for meeting the requirements of §§A — D of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".49" heading="Specialized Activities: Archery."> <paragraph num="A."> <text>Archery Range. For a camp that offers archery activities, an operator shall ensure that:</text> <paragraph num="(1)"> <text>An archery range is located where a camper will not wander into the danger area while engaged in other camp activities;</text> </paragraph> <paragraph num="(2)"> <text>An archery range is clearly marked to warn individuals away from the danger area;</text> </paragraph> <paragraph num="(3)"> <text>When possible, the shooting direction is to the north to minimize an archer being blinded by the sun;</text> </paragraph> <paragraph num="(4)"> <text>The shooting area has at least 50 yards of clearance or an archery net behind each target; and</text> </paragraph> <paragraph num="(5)"> <text>When different archer-to-target distances are required for a group that is shooting at the same time on the same field:</text> <paragraph num="(a)"> <text>One common shooting line is used; and</text> </paragraph> <paragraph num="(b)"> <text>The targets are set at a distance from the shooting line that is appropriate with the skill level of the camper.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure that:</text> <paragraph num="(1)"> <text>Archers fire from a common firing line with a ready line marked behind it;</text> </paragraph> <paragraph num="(2)"> <text>Only an archer ready to shoot is on the firing line and anyone waiting to shoot remains behind the ready line;</text> </paragraph> <paragraph num="(3)"> <text>An individual stays behind the firing line at all times except when ordered by the instructor to retrieve a target or an arrow; and</text> </paragraph> <paragraph num="(4)"> <text>Bows and arrows are stored in a locked enclosure.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff Members. For a camp that offers archery activities, an operator shall ensure that:</text> <paragraph num="(1)"> <text>During the archery activity, a director is present at the camp or, when the activity occurs off the camp premises, the activity site;</text> </paragraph> <paragraph num="(2)"> <text>An instructor and at least one counselor or assistant counselor to assist are on the range at all times during a firing session; and</text> </paragraph> <paragraph num="(3)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or fraction of ten campers on the firing line.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Procedures. An operator shall ensure that a safety plan is developed and implemented:</text> <paragraph num="(1)"> <text>According to Regulation .52 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>That includes procedures for meeting the requirements of §§A — C of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".50" heading="Specialized Activities: Horseback Riding."> <paragraph num="A."> <text>For a camp that offers horseback riding, an operator shall ensure that:</text> <paragraph num="(1)"> <text>A riding instructor determines a camper's riding experience and level of skill before assigning a horse and deciding whether the camper rides in a ring or on a trail;</text> </paragraph> <paragraph num="(2)"> <text>A rider wears:</text> <paragraph num="(a)"> <text>Protective headgear at all times that bears the label of the American Society for Testing and Materials (ASTM) F1163; and</text> </paragraph> <paragraph num="(b)"> <text>Shoes with heels or uses closed stirrups;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All horses are healthy and well cared for; and</text> </paragraph> <paragraph num="(4)"> <text>A horse riding stable meets the requirements of COMAR 15.16.01 and is maintained in good condition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Members. For a camp that offers horseback riding, an operator shall ensure that:</text> <paragraph num="(1)"> <text>During the horseback riding activity, a director is present at the camp or, when the activity occurs off the camp premises, at the activity site;</text> </paragraph> <paragraph num="(2)"> <text>An instructor is present at each:</text> <paragraph num="(a)"> <text>Horseback riding activity; and</text> </paragraph> <paragraph num="(b)"> <text>Trail excursion; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten riders or a fraction of ten riders at each:</text> <paragraph num="(a)"> <text>Horseback riding activity; and</text> </paragraph> <paragraph num="(b)"> <text>Trail excursion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures. An operator shall ensure that a safety plan is developed and implemented:</text> <paragraph num="(1)"> <text>According to Regulation .52 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>That includes procedures for meeting the requirements of §§A and B of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".51" heading="Other Specialized Activities."> <paragraph num="A."> <text>An operator shall ensure that a specialized activity safety plan is developed and implemented according to §C of this regulation for a camp that offers a specialized activity or program of:</text> <paragraph num="(1)"> <text>Firearms control;</text> </paragraph> <paragraph num="(2)"> <text>Adventure camping;</text> </paragraph> <paragraph num="(3)"> <text>Artistic gymnastics;</text> </paragraph> <paragraph num="(4)"> <text>Hang gliding;</text> </paragraph> <paragraph num="(5)"> <text>Road cycling;</text> </paragraph> <paragraph num="(6)"> <text>Skiing;</text> </paragraph> <paragraph num="(7)"> <text>Rock climbing;</text> </paragraph> <paragraph num="(8)"> <text>Spelunking;</text> </paragraph> <paragraph num="(9)"> <text>Motorized vehicle activities;</text> </paragraph> <paragraph num="(10)"> <text>Rappelling; or</text> </paragraph> <paragraph num="(11)"> <text>High ropes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Members. For a camp that offers a specialized activity set forth in §A of this regulation, an operator shall ensure that during the specialized activity:</text> <paragraph num="(1)"> <text>A director is present at the camp or, when the activity occurs off the camp premises, the activity site;</text> </paragraph> <paragraph num="(2)"> <text>An instructor is present at the specialized activity; and</text> </paragraph> <paragraph num="(3)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or fraction of ten campers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures. An operator shall ensure that a safety plan is developed and implemented:</text> <paragraph num="(1)"> <text>According to Regulation .52 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>That includes procedures for meeting the requirements of §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except when an auto-belay system is utilized, an individual participating in rock climbing or high ropes activities, regardless of whether the activity occurs on manufactured equipment or natural formations, shall wear a helmet.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".52" heading="Specialized Activity and Camp Trip Safety."> <paragraph num="A."> <text>Safety Plan. An operator shall ensure that a written safety plan:</text> <paragraph num="(1)"> <text>Is prepared for each specialized activity, specialized activity location, and trip before a camper participates in a specialized activity or embarks on a trip;</text> </paragraph> <paragraph num="(2)"> <text>Defines and addresses the potential health and safety risks for each specialized activity and trip;</text> </paragraph> <paragraph num="(3)"> <text>Identifies camp staff members' qualifications and responsibilities for each specialized activity and trip;</text> </paragraph> <paragraph num="(4)"> <text>Includes operating procedures for:</text> <paragraph num="(a)"> <text>Informing a parent or guardian, camper, staff member, and volunteer of the activity before a camper participates in an activity or embarks on a trip;</text> </paragraph> <paragraph num="(b)"> <text>Obtaining written authorization from a child's parent or guardian before the child participates in an activity or embarks on a trip;</text> </paragraph> <paragraph num="(c)"> <text>Participation eligibility requirements;</text> </paragraph> <paragraph num="(d)"> <text>Supervision requirements including camper to staff member ratios;</text> </paragraph> <paragraph num="(e)"> <text>Safety rules, standards, and practices; and</text> </paragraph> <paragraph num="(f)"> <text>Equipment use, maintenance, and storage; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When an activity occurs off the camp premises, includes procedures for:</text> <paragraph num="(a)"> <text>Maintaining campers, staff members, and volunteers' health and emergency information including when and where the information is maintained;</text> </paragraph> <paragraph num="(b)"> <text>Emergency communication;</text> </paragraph> <paragraph num="(c)"> <text>Designating a contact person; and</text> </paragraph> <paragraph num="(d)"> <text>Attendance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Camp Trip.</text> <paragraph num="(1)"> <text>Staff Members. An operator shall ensure that on a camp trip:</text> <paragraph num="(a)"> <text>A director is present;</text> </paragraph> <paragraph num="(b)"> <text>One adult staff member, adult volunteer, counselor, or assistant counselor is on duty and supervising the campers for each group of ten campers or a fraction of ten campers;</text> </paragraph> <paragraph num="(c)"> <text>An adult with cardiopulmonary resuscitation certification from a national organization is on duty; and</text> </paragraph> <paragraph num="(d)"> <text>An adult with first aid certification from a national organization is on duty.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An operator shall ensure that the camp's contact person maintains trip information including:</text> <paragraph num="(a)"> <text>A roster of participants;</text> </paragraph> <paragraph num="(b)"> <text>Departure and return times;</text> </paragraph> <paragraph num="(c)"> <text>Attendance during the:</text> <paragraph num="(i)"> <text>Departure;</text> </paragraph> <paragraph num="(ii)"> <text>Activity; and</text> </paragraph> <paragraph num="(iii)"> <text>Return;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>An itinerary;</text> </paragraph> <paragraph num="(e)"> <text>The route taken; and</text> </paragraph> <paragraph num="(f)"> <text>Inclement weather plans;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Specialized Activity and Camp Trip Safety Training. An operator shall ensure that:</text> <paragraph num="(1)"> <text>Not more than 30 calendar days before working at the camp's specialized activity or participating in a trip, each staff member or volunteer:</text> <paragraph num="(a)"> <text>Is trained in the camp's safety plan;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrates knowledge of the camp's safety plan; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided with the opportunity to discuss the procedures and have any questions answered by a supervisor; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation is kept on file that each staff member or volunteer received the training required in §C(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Specialized Activity and Camp Trip Safety Procedures. An operator shall ensure that:</text> <paragraph num="(1)"> <text>A camper is instructed in safety procedures and the use of protective equipment;</text> </paragraph> <paragraph num="(2)"> <text>A camper, staff member, or volunteer is provided with and uses safety equipment suitable to the specialized activity or camp trip; and</text> </paragraph> <paragraph num="(3)"> <text>The specialized activity or trip is conducted according to the safety plan.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".53" heading="Transportation."> <paragraph num="A."> <text>When a camper, staff member, or volunteer is transported, an operator shall ensure that:</text> <paragraph num="(1)"> <text>Transportation is provided according to applicable State law;</text> </paragraph> <paragraph num="(2)"> <text>A transportation safety plan is developed and implemented that includes:</text> <paragraph num="(a)"> <text>Transportation safety rules, standards, and practices;</text> </paragraph> <paragraph num="(b)"> <text>Supervision requirements including camper to staff ratios;</text> </paragraph> <paragraph num="(c)"> <text>Emergency transportation services; and</text> </paragraph> <paragraph num="(d)"> <text>Severe weather procedures;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Not more than 30 calendar days before the camp uses transportation, each staff member or volunteer involved in the transportation and each transportation service provider or driver:</text> <paragraph num="(a)"> <text>Is trained in the camp's transportation safety plan;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrates knowledge of the camp's transportation safety plan; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided with the opportunity to discuss the procedures and have questions answered by a supervisor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Documentation is kept on file that each staff member or volunteer received the training required in §A(3) of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>A camper, staff member, or volunteer is provided with and uses transportation safety equipment;</text> </paragraph> <paragraph num="(6)"> <text>The driver of a vehicle is:</text> <paragraph num="(a)"> <text>An adult; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed according to applicable State law;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The number of occupants in a vehicle does not exceed the vehicle manufacturer's seating capacity;</text> </paragraph> <paragraph num="(8)"> <text>Before a camper is transported, written authorization from a camper's parent or guardian is obtained; and</text> </paragraph> <paragraph num="(9)"> <text>Vehicular traffic is controlled on the campsite.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When the camp operator provides or arranges camper transportation to camp, from camp, or to and from camp, the operator shall:</text> <paragraph num="(1)"> <text>Ensure that a director is available for consultation;</text> </paragraph> <paragraph num="(2)"> <text>Provide written information to the camper's parent or guardian that includes the:</text> <paragraph num="(a)"> <text>Camper's pick-up time and designated pick-up location;</text> </paragraph> <paragraph num="(b)"> <text>Camper's drop-off time and designated drop-off location;</text> </paragraph> <paragraph num="(c)"> <text>Camp's pick-up and drop-off safety procedures;</text> </paragraph> <paragraph num="(d)"> <text>Camp's policy concerning the camp's responsibility for supervising a camper when the camper is picked up, dropped off, and transported;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain a written agreement from the camper's parent or guardian concerning the parent's or guardian's responsibility for supervising a camper before the camper is picked up and after the camper is dropped off; and</text> </paragraph> <paragraph num="(4)"> <text>In addition to the driver, ensure that one assistant counselor or adult is on duty and supervising the campers when there are ten or more campers in a vehicle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An operator may not transport a camper in a:</text> <paragraph num="(1)"> <text>Non-passenger vehicle; or</text> </paragraph> <paragraph num="(2)"> <text>An individual's car without obtaining written authorization from the:</text> <paragraph num="(a)"> <text>Camper's parent or guardian; and</text> </paragraph> <paragraph num="(b)"> <text>Owner of the vehicle.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".54" heading="Supervision of Campers During Routine Activities."> <text>During a routine activity, an operator shall ensure that:</text> <paragraph num="A."> <text>A camp director is available for consultation at all times when campers are present at a camp;</text> </paragraph> <paragraph num="B."> <text>For campers who are 3-1/2 to 5 years old:</text> <paragraph num="(1)"> <text>When there are one to eight campers, one adult is on duty and supervising the camper or campers;</text> </paragraph> <paragraph num="(2)"> <text>When there are nine to 16 campers, on duty and supervising the campers are:</text> <paragraph num="(a)"> <text>One adult; and</text> </paragraph> <paragraph num="(b)"> <text>A second staff member who is an assistant counselor or adult;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When there are 17 to 24 campers, on duty and supervising the campers are:</text> <paragraph num="(a)"> <text>One adult; and</text> </paragraph> <paragraph num="(b)"> <text>Two additional staff members who are assistant counselors or adults; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A group does not exceed 24 campers;</text> </paragraph> </paragraph> <paragraph num="C."> <text>For campers who are 6 to 10 years old:</text> <paragraph num="(1)"> <text>When there are one to 15 campers, one adult is on duty and supervising the campers;</text> </paragraph> <paragraph num="(2)"> <text>When there are 16 to 30 campers, on duty and supervising the campers are:</text> <paragraph num="(a)"> <text>One adult and two assistant counselors; or</text> </paragraph> <paragraph num="(b)"> <text>Two adults; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A group does not exceed 30 campers;</text> </paragraph> </paragraph> <paragraph num="D."> <text>For campers who are 11 years old or older:</text> <paragraph num="(1)"> <text>When there are one to 15 campers, one adult is on duty and supervising the campers;</text> </paragraph> <paragraph num="(2)"> <text>When there are 16 to 30 campers, on duty and supervising the campers are:</text> <paragraph num="(a)"> <text>One adult and two assistant counselors; or</text> </paragraph> <paragraph num="(b)"> <text>Two adults;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When there are 31 to 40 campers, on duty and supervising the campers are:</text> <paragraph num="(a)"> <text>Two adults and two assistant counselors; or</text> </paragraph> <paragraph num="(b)"> <text>Three adults; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A group does not exceed 40 campers;</text> </paragraph> </paragraph> <paragraph num="E."> <text>When a camper who is 3-1/2 to 5 years old is grouped together with older campers, supervision is provided as required in §B of this regulation;</text> </paragraph> <paragraph num="F."> <text>When a camper who is 6 to 10 years old is grouped together with older campers, supervision is provided as required in §C of this regulation; and</text> </paragraph> <paragraph num="G."> <text>An assistant counselor under the direction of an adult may supervise, for up to 30 minutes, no more than five campers without an adult supervisor present.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".55" heading="Implementation of This Chapter."> <text>Implementation of this chapter is contingent on the availability of funds.</text> </regulation> <annotations> <annotation type="Authority">Family Law Article, §§5-560—5-558, 5-704, and 5-705; Health-General Article, §§2-104, 14-402(d), 14-403, 14-403.1, 14-407, 18-318, and 18-403; Health Occupations Article, §§8-6A-01—8-6A-16 and 14-306; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .24 adopted as an emergency provision effective June 19, 1989 (16:13 Md. R. 1413); emergency status expired November 12, 1989</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .24 adopted effective June 11, 1990 (17:11 Md. R. 1343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B and .05A amended as an emergency provision effective June 30, 1994 (21:15 Md. R. 1301); emergency status expired effective December 31, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B and D amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 and .05-2 adopted effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A and B amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19C amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C and D amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21E amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23B amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective March 2, 1992 (19:4 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .24 repealed and new Regulations .01 — .55 adopted effective September 1, 2004 (31:2 Md. R. 85)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 5, 2011 (38:10 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended as an emergency provision effective April 5, 2011 (38:10 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27E amended as an emergency provision effective May 12, 2011 (38:12 Md. R. 703)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27E amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .33A amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1052); emergency status expired effective January 3, 2016</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 6, 2025 (52:2 Md. R. 65); amended permanently effective April 14, 2025 (52:7 Md. R. 321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended as an emergency provision effective January 6, 2025 (52:2 Md. R. 65); amended permanently effective April 14, 2025 (52:7 Md. R. 321)</annotation> </annotations> </chapter> <chapter num="07" heading="Health and Medication Requirements for Youth Camps"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to programs or activities that meet the definition of youth camp as defined in COMAR 10.16.06.02.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute illness” means an abnormal condition of the body with rapid onset associated with recognizable symptoms and signs, such as chicken pox, gastroenteritis, influenza, or streptococcal sore throat, which has a short course of duration, as opposed to a chronic illness of long duration lasting 30 calendar days or more.</text> </paragraph> <paragraph num="(2)"> <text>Administer Medication.</text> <paragraph num="(a)"> <text>“Administer medication” means the act of providing, preparing, or applying a medication.</text> </paragraph> <paragraph num="(b)"> <text>“Administer medication” does not include:</text> <paragraph num="(i)"> <text>Reminding a camper to take a medication; or</text> </paragraph> <paragraph num="(ii)"> <text>Providing physical assistance with opening and removing a medication from the container or locked storage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Adult” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(4)"> <text>“Agent” means an individual who:</text> <paragraph num="(a)"> <text>Is at least 18 years old;</text> </paragraph> <paragraph num="(b)"> <text>Has successfully completed, at the expense of an applicant, an emergency epinephrine educational training program approved by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Is appointed by a certificate for emergency epinephrine holder to administer emergency use epinephrine in an emergency situation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Anaphylaxis” means a sudden, severe, and potentially life-threatening allergic reaction that occurs when an individual is exposed to an allergen.</text> </paragraph> <paragraph num="(6)"> <text>“Applicant” means an individual applying for a Certificate for Emergency Epinephrine.</text> </paragraph> <paragraph num="(7)"> <text>“Camp” means a youth camp as defined in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(8)"> <text>“Camper” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(9)"> <text>“Certificate” means a document showing the authority to operate a youth camp, issued by the Maryland Department of Health pursuant to COMAR 10.16.06 and Health-General Article, §14-403, Annotated Code of Maryland, which displays the name of the person granted the authority.</text> </paragraph> <paragraph num="(10)"> <text>“Certificate for emergency epinephrine” means a certificate or an endorsement on the operating certificate of a youth camp issued by the Maryland Department of Health to an individual who operates a youth camp under COMAR 10.16.06 to obtain, store, and administer emergency use epinephrine.</text> </paragraph> <paragraph num="(11)"> <text>“Certificate for emergency epinephrine holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer emergency use epinephrine to be used in an emergency situation.</text> </paragraph> <paragraph num="(12)"> <text>“Day” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(13)"> <text>“Department” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(14)"> <text>“Director” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(15)"> <text>“Emergency medication” means a medication, identified by a camper’s plan of action for use in case of a medical emergency, for a camper with an identified medical problem.</text> </paragraph> <paragraph num="(16)"> <text>“Emergency use epinephrine” means a portable, disposable drug delivery device or product approved by the federal Food and Drug Administration that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.</text> </paragraph> <paragraph num="(17)"> <text>“Health supervisor” means an individual who:</text> <paragraph num="(a)"> <text>Provides health services for a camp; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed by the State as a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Certified nurse practitioner; or</text> </paragraph> <paragraph num="(iii)"> <text>Registered nurse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>Identified Medical Problem.</text> <paragraph num="(a)"> <text>“Identified medical problem” means a chronic physical condition diagnosed by a licensed health care professional that:</text> <paragraph num="(i)"> <text>Requires specific medical treatment and supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>If untreated, can adversely affect the general health of the camper.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Identified medical problem” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Asthma;</text> </paragraph> <paragraph num="(ii)"> <text>Cancer;</text> </paragraph> <paragraph num="(iii)"> <text>Diabetes; and</text> </paragraph> <paragraph num="(iv)"> <text>Epilepsy.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Identified medical problem” does not include a chronic physical condition, which does not typically cause other medical problems or have an adverse effect on the general health of the camper, such as:</text> <paragraph num="(i)"> <text>Blindness;</text> </paragraph> <paragraph num="(ii)"> <text>Deafness; or</text> </paragraph> <paragraph num="(iii)"> <text>A developmental disability.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Medication” means any nonprescription or prescription medication present at camp.</text> </paragraph> <paragraph num="(20)"> <text>“Operate” means to supervise, control, conduct, or manage a youth camp as:</text> <paragraph num="(a)"> <text>An owner;</text> </paragraph> <paragraph num="(b)"> <text>An agent of the owner;</text> </paragraph> <paragraph num="(c)"> <text>A lessee of the owner;</text> </paragraph> <paragraph num="(d)"> <text>A director; or</text> </paragraph> <paragraph num="(e)"> <text>An independent contractor.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Operator” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(22)"> <text>“Person” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(23)"> <text>“Secretary” has the meaning stated in COMAR 10.16.06.02.</text> </paragraph> <paragraph num="(24)"> <text>“Self-administer medication” means the act of an individual’s ingesting, injecting, or applying the individual’s own medication when the individual:</text> <paragraph num="(a)"> <text>Identifies the individual’s own medication; and</text> </paragraph> <paragraph num="(b)"> <text>Follows the directions for use, including the correct route, dose, and frequency.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Successfully completed” means to pass a written examination with a grade of 75 percent or higher.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Health Program."> <paragraph num="A."> <text>An operator shall prepare and implement a written health program that:</text> <paragraph num="(1)"> <text>Is approved annually, in writing, by a physician, certified nurse practitioner, or registered nurse licensed to practice in the State;</text> </paragraph> <paragraph num="(2)"> <text>Is on file in the headquarters or office of the camp and is available to the camp staff members;</text> </paragraph> <paragraph num="(3)"> <text>Includes the name, title, and license number of the health supervisor;</text> </paragraph> <paragraph num="(4)"> <text>Includes procedures for the camp staff members to:</text> <paragraph num="(a)"> <text>Obtain camper, staff, and volunteer health information;</text> </paragraph> <paragraph num="(b)"> <text>Notify the camp health supervisor when a camper has an identified medical problem to ensure that there is a plan of action at the camp in case of a medical emergency;</text> </paragraph> <paragraph num="(c)"> <text>Disseminate information to staff members that work with a camper having a health problem;</text> </paragraph> <paragraph num="(d)"> <text>Care for a camper with an identified medical problem;</text> </paragraph> <paragraph num="(e)"> <text>Maintain confidentiality regarding all health information on campers and staff members;</text> </paragraph> <paragraph num="(f)"> <text>Observe campers each day for easily discernible signs of injury or illness;</text> </paragraph> <paragraph num="(g)"> <text>Handle health emergencies and accidents;</text> </paragraph> <paragraph num="(h)"> <text>Use emergency ambulance services and 911 services;</text> </paragraph> <paragraph num="(i)"> <text>Care for and supervise an injured or ill camper until the camper is returned to the parent, guardian, or the parent’s or guardian’s designee;</text> </paragraph> <paragraph num="(j)"> <text>Notify a parent, guardian, or the parent’s or guardian’s designee when a camper is observed to be injured or ill;</text> </paragraph> <paragraph num="(k)"> <text>Report health situations in accordance with Regulations .06 and .07 of this chapter; and</text> </paragraph> <paragraph num="(l)"> <text>Prevent the spread of an infectious disease using:</text> <paragraph num="(i)"> <text>Hand washing procedures;</text> </paragraph> <paragraph num="(ii)"> <text>Personal protective equipment;</text> </paragraph> <paragraph num="(iii)"> <text>Personal hygiene; and</text> </paragraph> <paragraph num="(iv)"> <text>An exposure control plan;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Includes procedures for handling medication at camp in accordance with Regulation .14 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>If using electronic records, includes procedures for, in the event that a power or server outage prevents access to the electronic record:</text> <paragraph num="(a)"> <text>Accessing camper, staff, and volunteer health information;</text> </paragraph> <paragraph num="(b)"> <text>Documenting injuries, illnesses, and other reportable diseases and conditions in a paper health log; and</text> </paragraph> <paragraph num="(c)"> <text>Documenting medication administration on a paper form.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An operator shall ensure and document that, not more than 30 calendar days before working at the camp, each staff member or volunteer:</text> <paragraph num="(1)"> <text>Is trained in the health program;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates knowledge of the health program procedures; and</text> </paragraph> <paragraph num="(3)"> <text>Is provided with the opportunity to discuss the procedures and have any questions answered by a supervisor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A staff member or volunteer shall conduct health procedures according to the health program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Health Personnel."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>A camp health supervisor is:</text> <paragraph num="(1)"> <text>Available for consultation at all times when campers are present at a camp; and</text> </paragraph> <paragraph num="(2)"> <text>On site at all times when campers are present in a camp where 50 percent or more of the campers have identified medical problems;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Two adults with cardiopulmonary resuscitation certification by a national organization with a training program in cardiopulmonary resuscitation are on duty at all times;</text> </paragraph> <paragraph num="C."> <text>If a camp has campers participating in a trip and campers remaining at camp, an adult with cardiopulmonary resuscitation certification by a national organization with a training program in cardiopulmonary resuscitation is on duty:</text> <paragraph num="(1)"> <text>With the trip; and</text> </paragraph> <paragraph num="(2)"> <text>At the camp;</text> </paragraph> </paragraph> <paragraph num="D."> <text>The cardiopulmonary resuscitation certification by the national organization is appropriate to the age of campers and staff members;</text> </paragraph> <paragraph num="E."> <text>Two adults with first aid certification by a national organization with a training program in first aid are on duty at all times; and</text> </paragraph> <paragraph num="F."> <text>If a camp has campers participating in a trip and campers remaining at camp, an adult with first aid certification by a national organization with a training program in first aid is on duty:</text> <paragraph num="(1)"> <text>With the trip; and</text> </paragraph> <paragraph num="(2)"> <text>At the camp.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Health Log."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>A camp staff member records in the camp health log, for all injuries, illnesses, medication errors, and reportable diseases and conditions as delineated in COMAR 10.06.01, the:</text> <paragraph num="(1)"> <text>Date;</text> </paragraph> <paragraph num="(2)"> <text>Name of individual;</text> </paragraph> <paragraph num="(3)"> <text>Ailment;</text> </paragraph> <paragraph num="(4)"> <text>Treatment prescribed; and</text> </paragraph> <paragraph num="(5)"> <text>Name of the individual administering care or initials of the individual administering care if a list of names and initials is provided at the front of the health log;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The camp health log is:</text> <paragraph num="(1)"> <text>Written on lined paper;</text> </paragraph> <paragraph num="(2)"> <text>Maintained in a confidential manner;</text> </paragraph> <paragraph num="(3)"> <text>Stored in a locked compartment;</text> </paragraph> <paragraph num="(4)"> <text>Available at all times for review by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Retained for a period of 3 years;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each entry in the camp health log is:</text> <paragraph num="(1)"> <text>Recorded in ink and no lines are skipped, providing a permanent record that is not easily modified; and</text> </paragraph> <paragraph num="(2)"> <text>Legibly signed by the individual administering care at the camp; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>The camp health log is a:</text> <paragraph num="(1)"> <text>Bound volume, such as a composition notebook;</text> </paragraph> <paragraph num="(2)"> <text>Spiral book with sequentially numbered pages; or</text> </paragraph> <paragraph num="(3)"> <text>Dedicated paper record per individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Required Health Reports."> <text>For all campers, staff members, and volunteers, an operator shall ensure that:</text> <paragraph num="A."> <text>An injury or illness that results in death or that requires resuscitation or admission to a hospital is reported:</text> <paragraph num="(1)"> <text>Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian;</text> </paragraph> <paragraph num="(2)"> <text>Verbally to the Department within 24 hours; and</text> </paragraph> <paragraph num="(3)"> <text>To the Department within 1 week of the incident, on a form that meets the requirements of Regulation .07 of this chapter;</text> </paragraph> </paragraph> <paragraph num="B."> <text>An injury that is treated at an off-site medical facility and that results in a positive diagnosis through clinical examination, laboratory test, or X-ray is reported:</text> <paragraph num="(1)"> <text>Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>To the Department within 4 weeks of the end of camp on a form that meets the requirements of Regulation .07 of this chapter;</text> </paragraph> </paragraph> <paragraph num="C."> <text>When a camp health supervisor is on duty at the camp, an accident with no apparent injury, such as a fall from a horse, a fall from equipment, or impact from sports equipment, is reported immediately to the health supervisor;</text> </paragraph> <paragraph num="D."> <text>When a camp health supervisor is only available for consultation and not on duty at the camp, the minor’s parent or guardian is notified as soon as possible and before the end of the camp day, verbally or in writing, of:</text> <paragraph num="(1)"> <text>An illness or injury that is not included in §A or B of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>An accident with no apparent injury, such as:</text> <paragraph num="(a)"> <text>A fall from a horse;</text> </paragraph> <paragraph num="(b)"> <text>A fall from equipment; or</text> </paragraph> <paragraph num="(c)"> <text>Impact from sports equipment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>An outbreak of a disease or a condition that is required to be reported pursuant to COMAR 10.06.01 is reported:</text> <paragraph num="(1)"> <text>Immediately to the health supervisor and in the case of a minor, to the minor’s parent or guardian;</text> </paragraph> <paragraph num="(2)"> <text>Verbally to the Department within 24 hours; and</text> </paragraph> <paragraph num="(3)"> <text>To the Department within 1 week of the incident on a form that meets the requirements of Regulation .07 of this chapter;</text> </paragraph> </paragraph> <paragraph num="F."> <text>A medication error or incident that required the administration of emergency use epinephrine is reported:</text> <paragraph num="(1)"> <text>Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>To the Department within 4 weeks of the end of camp on a form that meets the requirements of Regulation .07 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>A camp health supervisor and camp director shall:</text> <paragraph num="(1)"> <text>Annually review all health log records and identify opportunities to reduce incidents, accidents, injuries, and medication errors; and</text> </paragraph> <paragraph num="(2)"> <text>Make available to the Department for review written documentation of the findings of the review of health log records.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Reportable Condition Report Form."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>Any reportable condition described in Regulation .06 of this chapter is reported to the Department on a form prescribed by the Department;</text> </paragraph> <paragraph num="B."> <text>Each report form is:</text> <paragraph num="(1)"> <text>Completed in duplicate; and</text> </paragraph> <paragraph num="(2)"> <text>Signed and dated by the person completing the form;</text> </paragraph> </paragraph> <paragraph num="C."> <text>The original report form is maintained for at least 3 years; and</text> </paragraph> <paragraph num="D."> <text>A copy of the report is forwarded to the Department with personal identifiers removed to maintain confidentiality.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Camper’s Health Record."> <text>An operator shall ensure that each camper has on file at the time of admission to a youth camp a written personal health record that includes:</text> <paragraph num="A."> <text>The name of the camper’s primary care physician or other provider of medical care;</text> </paragraph> <paragraph num="B."> <text>Pertinent information on any health problem including a physical, psychiatric, or behavioral problem;</text> </paragraph> <paragraph num="C."> <text>The name and phone number of a parent or legal guardian and at least one additional person to contact in an emergency situation; and</text> </paragraph> <paragraph num="D."> <text>For a camper who currently resides:</text> <paragraph num="(1)"> <text>Within the United States, a United States territory, or the District of Columbia, documentation of:</text> <paragraph num="(a)"> <text>The camper’s residence; and</text> </paragraph> <paragraph num="(b)"> <text>Immunization exemptions because of a parental or guardian objection or medical contraindication; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Outside the United States, a United States territory, or the District of Columbia, documentation of:</text> <paragraph num="(a)"> <text>The camper’s residence; and</text> </paragraph> <paragraph num="(b)"> <text>Record of vaccination or immunity on a form prescribed by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Staff Member’s or Volunteer’s Health Record."> <text>An operator shall ensure that each staff member or volunteer has on file at the time of employment or volunteering at a youth camp a written personal health record that includes:</text> <paragraph num="A."> <text>The name of the staff member’s primary care physician or other provider of medical care;</text> </paragraph> <paragraph num="B."> <text>Pertinent information on any health problem including a physical, psychiatric, or behavioral problem;</text> </paragraph> <paragraph num="C."> <text>The name and phone number of a person to contact in an emergency; and</text> </paragraph> <paragraph num="D."> <text>For a staff member or volunteer who currently resides:</text> <paragraph num="(1)"> <text>Within the United States, a United States territory, or the District of Columbia, documentation of:</text> <paragraph num="(a)"> <text>The staff member’s or volunteer’s residence; and</text> </paragraph> <paragraph num="(b)"> <text>Immunization exemptions because of a parental or guardian objection or medical contraindication; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Outside the United States, a United States territory, or the District of Columbia, documentation of:</text> <paragraph num="(a)"> <text>The staff member’s or volunteer’s residence; and</text> </paragraph> <paragraph num="(b)"> <text>Record of vaccination or immunity on a form prescribed by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Electronic Records."> <paragraph num="A."> <text>All of the following records may be kept electronically:</text> <paragraph num="(1)"> <text>A health log;</text> </paragraph> <paragraph num="(2)"> <text>A camper health record;</text> </paragraph> <paragraph num="(3)"> <text>A staff or volunteer health record;</text> </paragraph> <paragraph num="(4)"> <text>A Medication Administration Authorization Form;</text> </paragraph> <paragraph num="(5)"> <text>A Medication Administration Form;</text> </paragraph> <paragraph num="(6)"> <text>A Medication Final Disposition Form; or</text> </paragraph> <paragraph num="(7)"> <text>When an operator uses standing orders for medication administration, a parent or guardian consent form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The camp operator shall ensure that an electronic record under §A of this regulation is:</text> <paragraph num="(1)"> <text>Capturing the same required information as the paper record being replaced;</text> </paragraph> <paragraph num="(2)"> <text>Password protected;</text> </paragraph> <paragraph num="(3)"> <text>Accessed only by authorized staff members;</text> </paragraph> <paragraph num="(4)"> <text>Permanent and will not be deleted;</text> </paragraph> <paragraph num="(5)"> <text>Capable of tracking staff member use of the system and producing an auditable record;</text> </paragraph> <paragraph num="(6)"> <text>Maintained in a confidential manner;</text> </paragraph> <paragraph num="(7)"> <text>Available at all times for review by the Department upon request; and</text> </paragraph> <paragraph num="(8)"> <text>Retained for a period of 3 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the electronic record under §A of this regulation is unavailable for any reason, the camp operator shall:</text> <paragraph num="(1)"> <text>Provide a paper health log that meets the requirements of Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Record all injuries, illnesses, medication errors, and reportable diseases and conditions as defined in COMAR 10.06.01 in the paper health log until access to the electronic record is restored;</text> </paragraph> <paragraph num="(3)"> <text>Transcribe all information recorded in the paper health log into the electronic record once access to the electronic record is restored;</text> </paragraph> <paragraph num="(4)"> <text>Annotate the paper health log to indicate that transcription has occurred;</text> </paragraph> <paragraph num="(5)"> <text>Retain the paper health log according to the time frame specified in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Provide an alternative means to access the electronic record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Exclusion During Vaccine-Preventable Disease Outbreaks."> <text>During an outbreak of a vaccine-preventable disease at a camp, the camp operator shall exclude:</text> <paragraph num="A."> <text>A camper who does not have documented vaccination or immunity to the relevant vaccine-preventable disease from attending the camp; and</text> </paragraph> <paragraph num="B."> <text>An individual who does not have documented vaccination or immunity to the relevant vaccine-preventable disease from working or volunteering at the camp.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Exclusion for Acute Illness and Communicable Disease."> <paragraph num="A."> <text>An operator shall ensure that camp staff members:</text> <paragraph num="(1)"> <text>Monitor a camper for signs and symptoms of acute illness such as vomiting, diarrhea, or a fever;</text> </paragraph> <paragraph num="(2)"> <text>Arrange for first aid or medical treatment upon observing a sign or symptom of acute illness;</text> </paragraph> <paragraph num="(3)"> <text>Restrict an affected camper from participating in camp activities so that the camper’s illness is not communicated to another individual;</text> </paragraph> <paragraph num="(4)"> <text>Provide supervision for an affected camper so that the camper is within sight and hearing of the supervising staff member; and</text> </paragraph> <paragraph num="(5)"> <text>Upon observing a sign or symptom of acute illness:</text> <paragraph num="(a)"> <text>Report an illness in accordance with Regulation .06E of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Except for a residential camp as defined in COMAR 10.16.06.02, notify the camper’s parent, guardian, or other designated person that the camper may not remain at camp.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When an acute illness is reported to the health supervisor, the health supervisor shall:</text> <paragraph num="(1)"> <text>Provide medical consultation or treatment; and</text> </paragraph> <paragraph num="(2)"> <text>Report the situation to the local health department in accordance with COMAR 10.06.01.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a camper is exhibiting a symptom of acute illness, an operator may not:</text> <paragraph num="(1)"> <text>Admit an individual to a camp; or</text> </paragraph> <paragraph num="(2)"> <text>Except for a residential camp as defined in COMAR 10.16.06.02, allow a camper to remain in a camp.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An operator may not knowingly allow an individual to participate, work, or volunteer at camp during the period of communicability of a disease or condition listed in COMAR 10.06.01, unless:</text> <paragraph num="(1)"> <text>The individual is under the care of a licensed health care practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>A licensed health care practitioner or local health officer as applicable approves, in writing, the individual’s attendance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Health Treatment."> <text>An operator shall ensure that:</text> <paragraph num="A."> <text>A health treatment area:</text> <paragraph num="(1)"> <text>Is maintained within the camp for the temporary isolation and treatment of sick or injured campers;</text> </paragraph> <paragraph num="(2)"> <text>Affords privacy, quiet, continual supervision, and protection from the elements;</text> </paragraph> <paragraph num="(3)"> <text>Is equipped with:</text> <paragraph num="(a)"> <text>First aid supplies specified by the health supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>Provisions for sanitary hand washing; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the case of a residential camp as defined in COMAR 10.16.06.02, except for a primitive camp as defined in COMAR 10.16.06.02, provides:</text> <paragraph num="(a)"> <text>Hot and cold running water;</text> </paragraph> <paragraph num="(b)"> <text>A bathroom with a flush toilet;</text> </paragraph> <paragraph num="(c)"> <text>A hand sink;</text> </paragraph> <paragraph num="(d)"> <text>A shower;</text> </paragraph> <paragraph num="(e)"> <text>An isolation and convalescent area; and</text> </paragraph> <paragraph num="(f)"> <text>Exterior lighting; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Staff members or volunteers wash their hands before and after treatment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Medications."> <paragraph num="A."> <text>An operator shall ensure that:</text> <paragraph num="(1)"> <text>Except for medication covered by standing orders as described in §I of this regulation, before administration of a medication, written authorization is provided on a Medication Administration Authorization Form meeting the requirements of §F of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Except for a primitive camp as defined in COMAR 10.16.06.02, emergency medication, or while a medication is being administered, medication is kept in a locked storage compartment;</text> </paragraph> <paragraph num="(3)"> <text>A prescription medication is kept in the original container bearing a pharmacy label that includes the:</text> <paragraph num="(a)"> <text>Prescription number;</text> </paragraph> <paragraph num="(b)"> <text>Date filled;</text> </paragraph> <paragraph num="(c)"> <text>Authorized prescriber’s name;</text> </paragraph> <paragraph num="(d)"> <text>Patient’s name;</text> </paragraph> <paragraph num="(e)"> <text>Name of the medication;</text> </paragraph> <paragraph num="(f)"> <text>Dose of the medication;</text> </paragraph> <paragraph num="(g)"> <text>Route of administration for the medication;</text> </paragraph> <paragraph num="(h)"> <text>Time or frequency of administration for the medication; and</text> </paragraph> <paragraph num="(i)"> <text>Expiration date;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A nonprescription medication is kept in the original container that includes the directions for use;</text> </paragraph> <paragraph num="(5)"> <text>Medication is given to the camper from the original container;</text> </paragraph> <paragraph num="(6)"> <text>The directions provided in the prescriptive order for the medication found on the Medication Administration Authorization Form or the standing order is followed;</text> </paragraph> <paragraph num="(7)"> <text>The staff member or designated volunteer administering the medication or supervising a camper who is self-administering medication knows the side effects and toxic effects of the medication;</text> </paragraph> <paragraph num="(8)"> <text>Medication is kept in a secure manner;</text> </paragraph> <paragraph num="(9)"> <text>Emergency medications are handled according to §D of this regulation;</text> </paragraph> <paragraph num="(10)"> <text>Medication is stored according to the manufacturer’s directions;</text> </paragraph> <paragraph num="(11)"> <text>A staff member or designated volunteer documents medication administration on a Medication Administration Form meeting the requirements of §G of this regulation;</text> </paragraph> <paragraph num="(12)"> <text>A staff member or designated volunteer documents the final disposition of the medication on a Medication Final Disposition Form meeting the requirements of §H of this regulation;</text> </paragraph> <paragraph num="(13)"> <text>Except as allowed in §A(14) of this regulation, within 2 weeks after the end of the camping session or when the medication is discontinued, medication is:</text> <paragraph num="(a)"> <text>Returned to:</text> <paragraph num="(i)"> <text>The parent;</text> </paragraph> <paragraph num="(ii)"> <text>The guardian; or</text> </paragraph> <paragraph num="(iii)"> <text>An individual designated by the parent or guardian who has authorization to pick-up the camper and the medication; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Destroyed; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>If authorized by the parent or guardian, a camper may take their medication with them at the end of the camping session.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Administration — Routine Medication. Except as allowed in §E of this regulation, an operator shall ensure that a routine medication, other than insulin, is administered by:</text> <paragraph num="(1)"> <text>A licensed or certified professional:</text> <paragraph num="(a)"> <text>Who is authorized to practice in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Whose scope of practice includes medication administration; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An adult staff member or a volunteer who:</text> <paragraph num="(a)"> <text>Is designated by the operator; and</text> </paragraph> <paragraph num="(b)"> <text>On an annual basis successfully completes a training course approved annually by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staff Administration — Insulin. Except as allowed in §E of this regulation, an operator shall ensure that insulin is administered by a licensed or certified professional:</text> <paragraph num="(1)"> <text>Who is authorized to practice in Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Whose scope of practice includes medication administration.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staff Administration — Emergency Medication.</text> <paragraph num="(1)"> <text>Except as allowed in Regulation .15 of this chapter, an operator shall ensure that:</text> <paragraph num="(a)"> <text>Emergency medication is:</text> <paragraph num="(i)"> <text>Carried by the camper needing the medication if authorized according to §E(2) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Carried by an adult staff member or volunteer directly supervising the camper; or</text> </paragraph> <paragraph num="(iii)"> <text>Stored at a designated easily accessible location; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Emergency medication is administered by:</text> <paragraph num="(i)"> <text>The camper so long as the camper is capable and authorized to self-administer according to §E of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>An adult staff member or volunteer meeting the requirements of §B of this regulation; or</text> </paragraph> <paragraph num="(iii)"> <text>An adult staff member or volunteer trained by a health supervisor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An operator may allow a camper to self-carry an emergency medication if both the parent or guardian and a licensed or authorized prescriber have provided written consent for the camper to self-carry the emergency medication.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Self-Administration. An operator may allow a camper to self-administer medication, including insulin, if:</text> <paragraph num="(1)"> <text>Both the parent or guardian and a licensed or authorized prescriber have provided written consent for the camper to self-administer the medication;</text> </paragraph> <paragraph num="(2)"> <text>The health supervisor has designated an adult staff member or volunteer to supervise the camper while the camper is self-administering medication; and</text> </paragraph> <paragraph num="(3)"> <text>The designated adult staff member or volunteer supervises the camper while the camper is self-administering medication.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Medication Administration Authorization Form. A Medication Administration Authorization Form shall include:</text> <paragraph num="(1)"> <text>The written prescriptive order for the medication that includes:</text> <paragraph num="(a)"> <text>The child’s name;</text> </paragraph> <paragraph num="(b)"> <text>The child’s date of birth;</text> </paragraph> <paragraph num="(c)"> <text>The condition for which the medication is being administered;</text> </paragraph> <paragraph num="(d)"> <text>Whether or not the medication is an emergency medication;</text> </paragraph> <paragraph num="(e)"> <text>The name of the medication;</text> </paragraph> <paragraph num="(f)"> <text>The dose of the medication;</text> </paragraph> <paragraph num="(g)"> <text>The route of administration for the medication;</text> </paragraph> <paragraph num="(h)"> <text>The time or frequency of administration for the medication;</text> </paragraph> <paragraph num="(i)"> <text>If PRN, the frequency and for what symptoms the medication should be administered;</text> </paragraph> <paragraph num="(j)"> <text>The known side effects of the medication specific to the camper;</text> </paragraph> <paragraph num="(k)"> <text>The date medication administration shall begin;</text> </paragraph> <paragraph num="(l)"> <text>The date medication administration shall end, not to exceed 1 year from the beginning date;</text> </paragraph> <paragraph num="(m)"> <text>The authorized prescriber’s name;</text> </paragraph> <paragraph num="(n)"> <text>The authorized prescriber’s title;</text> </paragraph> <paragraph num="(o)"> <text>The authorized prescriber’s telephone number;</text> </paragraph> <paragraph num="(p)"> <text>The authorized prescriber’s fax number;</text> </paragraph> <paragraph num="(q)"> <text>The authorized prescriber’s address;</text> </paragraph> <paragraph num="(r)"> <text>The authorized prescriber’s signature; and</text> </paragraph> <paragraph num="(s)"> <text>The date the form is signed by the authorized prescriber;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following statement: “I request the authorized youth camp operator, staff member or volunteer to administer the medication or to supervise the camper in self-administration as prescribed by the above authorized prescriber. I certify that I have legal authority to consent to medical treatment for the child named above, including the administration of medication at the facility. I understand that at the end of the authorized period an authorized individual must pick up the medication; otherwise, it will be discarded. I authorize camp personnel and the authorized prescriber indicated on this form to communicate in compliance with HIPAA”;</text> </paragraph> <paragraph num="(3)"> <text>The parent’s or guardian’s signature;</text> </paragraph> <paragraph num="(4)"> <text>The date the parent or guardian signed the form;</text> </paragraph> <paragraph num="(5)"> <text>The parent’s or guardian’s primary phone number;</text> </paragraph> <paragraph num="(6)"> <text>The parent’s or guardian’s alternative phone number;</text> </paragraph> <paragraph num="(7)"> <text>If a camp allows a camper to self-administer medication, authorization to self-administer medication that includes:</text> <paragraph num="(a)"> <text>The following statement: “I authorize self-administration of the above listed medication for the child named above under the supervision of the youth camp operator, a designated staff member or volunteer”;</text> </paragraph> <paragraph num="(b)"> <text>The signature of the authorized prescriber and the date the form is signed under the statement in §F(7)(a) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>The signature of the parent or guardian and the date the form is signed under the statement in §F(7)(a) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>If a camp allows a camper to self-carry emergency medication, authorization to self-carry emergency medication that includes whether the:</text> <paragraph num="(a)"> <text>Authorized prescriber gives permission for the child to self-carry emergency medication; and</text> </paragraph> <paragraph num="(b)"> <text>Parent or guardian gives permission for the child to self-carry emergency medication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Medication Administration Form. A Medication Administration Form shall include the:</text> <paragraph num="(1)"> <text>Child’s name;</text> </paragraph> <paragraph num="(2)"> <text>Child’s date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Name of the medication;</text> </paragraph> <paragraph num="(4)"> <text>Dose of the medication;</text> </paragraph> <paragraph num="(5)"> <text>Route of administration for the medication;</text> </paragraph> <paragraph num="(6)"> <text>Time or frequency of administration for the medication;</text> </paragraph> <paragraph num="(7)"> <text>Amount of medication administered;</text> </paragraph> <paragraph num="(8)"> <text>Date and time of administration; and</text> </paragraph> <paragraph num="(9)"> <text>Name of the individual who:</text> <paragraph num="(a)"> <text>Administered the medication to the child; or</text> </paragraph> <paragraph num="(b)"> <text>Supervised self-administration if the child self-administered the medication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Medication Final Disposition Form. A Medication Final Disposition Form shall include:</text> <paragraph num="(1)"> <text>The child’s name;</text> </paragraph> <paragraph num="(2)"> <text>The child’s date of birth;</text> </paragraph> <paragraph num="(3)"> <text>The name of the medication;</text> </paragraph> <paragraph num="(4)"> <text>The final disposition of the medication;</text> </paragraph> <paragraph num="(5)"> <text>Documentation that the medication is returned to the parent or guardian, or authorized individual, including the:</text> <paragraph num="(a)"> <text>Name of the individual to whom the medication was returned; and</text> </paragraph> <paragraph num="(b)"> <text>Signature of the staff member or volunteer who returned the medication; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A section for documenting that the medication was destroyed that includes the:</text> <paragraph num="(a)"> <text>Signature of the individual responsible for destroying the medication;</text> </paragraph> <paragraph num="(b)"> <text>Signature of the individual witnessing the destruction of the medication; and</text> </paragraph> <paragraph num="(c)"> <text>Dates each individual signed the form.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Standing Orders. When standing orders from a licensed or certified professional authorized to prescribe medication are used in place of the Medication Administration Authorization Form required in §A(1) of this regulation, an operator shall ensure that:</text> <paragraph num="(1)"> <text>Written permission is obtained from the child’s parent or guardian to administer the medication; and</text> </paragraph> <paragraph num="(2)"> <text>The medication is administered by a staff member or volunteer who meets the requirements in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Medications at Primitive Camps. Except for emergency medication that the camper is authorized to self-carry according to §E(2) of this regulation, in a primitive camp as defined in COMAR 10.16.06.02, medication is kept inaccessible to the camper.</text> </paragraph> <paragraph num="K."> <text>Staff Member or Volunteer Medication.</text> <paragraph num="(1)"> <text>An operator shall:</text> <paragraph num="(a)"> <text>Provide a means to secure medication for a staff member or volunteer when a medication is brought to camp; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that all staff member or volunteer medications are maintained in a secure manner at all times.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except when a staff member or volunteer is self-administering a medication, an operator shall:</text> <paragraph num="(a)"> <text>Ensure that a staff member or volunteer:</text> <paragraph num="(i)"> <text>Provides written authorization on a Medication Administration Authorization Form meeting the requirements of §F of this regulation for each medication brought to camp; and</text> </paragraph> <paragraph num="(ii)"> <text>Who is an adult, signs the Medication Administration Authorization Form in lieu of a parent or guardian; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a staff member or volunteer taking medication, have on file for each medication:</text> <paragraph num="(i)"> <text>A Medication Administration Authorization Form;</text> </paragraph> <paragraph num="(ii)"> <text>A Medication Administration Form; and</text> </paragraph> <paragraph num="(iii)"> <text>A Medication Final Disposition Form.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>Form Retention. An operator shall retain for 3 years and make available to the Department the completed:</text> <paragraph num="(1)"> <text>Medication Administration Authorization Form;</text> </paragraph> <paragraph num="(2)"> <text>Medication Administration Form;</text> </paragraph> <paragraph num="(3)"> <text>Medication Final Disposition Form; and</text> </paragraph> <paragraph num="(4)"> <text>Record of successful training for each staff member or volunteer who is trained to administer medication under §B(2) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Emergency Epinephrine."> <paragraph num="A."> <text>An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:</text> <paragraph num="(1)"> <text>Is an operator of a youth camp;</text> </paragraph> <paragraph num="(2)"> <text>Is at least 18 years old; and</text> </paragraph> <paragraph num="(3)"> <text>Has successfully completed, at the applicant’s expense, an emergency epinephrine educational training program approved by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:</text> <paragraph num="(1)"> <text>Designation of agents;</text> </paragraph> <paragraph num="(2)"> <text>The name of the approved emergency epinephrine educational training program; and</text> </paragraph> <paragraph num="(3)"> <text>Procedures to:</text> <paragraph num="(a)"> <text>Store emergency use epinephrine;</text> </paragraph> <paragraph num="(b)"> <text>Notify a parent or guardian that emergency use epinephrine is available at camp;</text> </paragraph> <paragraph num="(c)"> <text>Maintain the emergency use epinephrine in a secure manner;</text> </paragraph> <paragraph num="(d)"> <text>Report use of emergency use epinephrine according to Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Train an emergency epinephrine certificate holder and agent annually; and</text> </paragraph> <paragraph num="(f)"> <text>Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider of an emergency epinephrine educational training program may apply to the Department to have the training program recognized as approved for 5 years by submitting:</text> <paragraph num="(1)"> <text>An application form prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>A copy of all training program materials, including but not limited to handouts, presentations, and exams; and</text> </paragraph> <paragraph num="(3)"> <text>The following credentials of the instructor:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>License type as required in §E of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>License number.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An emergency epinephrine educational training program shall include:</text> <paragraph num="(1)"> <text>The signs and symptoms of anaphylaxis;</text> </paragraph> <paragraph num="(2)"> <text>Use of an emergency use epinephrine pen;</text> </paragraph> <paragraph num="(3)"> <text>Follow-up procedures with a parent or guardian after an emergency use epinephrine is administered;</text> </paragraph> <paragraph num="(4)"> <text>A skills demonstration; and</text> </paragraph> <paragraph num="(5)"> <text>A written examination.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.</text> </paragraph> <paragraph num="F."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Deny, revoke or suspend a certificate for emergency epinephrine from an applicant who does not meet the requirements in §§A and B of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>On or before January 31 of each year, publish a report summarizing the information obtained from the Reportable Incident Report Forms submitted to the Department related to the use of emergency use epinephrine at youth camps.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate for emergency epinephrine holder.</text> </paragraph> <paragraph num="H."> <text>A pharmacist licensed to practice pharmacy in the State or a physician may dispense emergency use epinephrine under a prescription issued to a certificate for emergency epinephrine holder.</text> </paragraph> <paragraph num="I."> <text>A certificate for emergency epinephrine holder may:</text> <paragraph num="(1)"> <text>On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for auto-injectable epinephrine; and</text> </paragraph> <paragraph num="(2)"> <text>Possess and store prescribed auto-injectable epinephrine.</text> </paragraph> </paragraph> <paragraph num="J."> <text>In an emergency situation when physician or emergency medical services are not immediately available, a certificate for emergency epinephrine holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate for emergency epinephrine holder or agent to be experiencing anaphylaxis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Appeal Rights."> <paragraph num="A."> <text>Except as otherwise provided in the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, or in this regulation, before the Department takes any final action to deny, suspend, or revoke a certificate for emergency epinephrine the Department shall give the person against whom the action is contemplated an opportunity for a hearing.</text> </paragraph> <paragraph num="B."> <text>The Department shall give the applicant for a certificate for emergency epinephrine:</text> <paragraph num="(1)"> <text>Written notice of the denial, suspension, or revocation of the certificate for emergency epinephrine;</text> </paragraph> <paragraph num="(2)"> <text>The reasons for the denial, suspension, or revocation; and</text> </paragraph> <paragraph num="(3)"> <text>In accordance with §A of this regulation, an opportunity for a hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A person shall request a hearing, if a hearing is desired, by submitting to the Department a written request for a hearing.</text> </paragraph> <paragraph num="D."> <text>To preserve the right to a hearing, a person shall submit the written request within 10 calendar days of the receipt of the denial, suspension, or revocation notice.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Family Law Article, §§5-560 — 5-568, 5-704, and 5-705; Health-General Article, §§2-104, 13-701 — 13-708, 14-402(d), 14-403, 18-318, and 18-403;Health Occupations Article, §§8-6A-01 — 8-6A-16 and 14-306; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13, .15, and .16 adopted effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted as an emergency provision effective June 30, 2016 (43:15 Md. R. 861); emergency expired effective December 26, 2016</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> </annotations> </chapter> </subtitle> <subtitle num="17" heading="Swimming Pools and Spas"> <chapter num="01" heading="Public Swimming Pools and Spas"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>The purpose of this chapter is to enact regulations that protect and promote the public health and safety of individuals at public spas and pools in Maryland. Public pools include limited public-use pools, recreational pools, and semipublic pools. Public spas include semipublic spas.</text> </paragraph> <paragraph num="B."> <text>This chapter adopts construction standards, updates disinfection standards, recognizes certain new technologies and design concepts, and establishes minimum criteria for public pools and spas.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Exclusions."> <text>This chapter does not apply to a:</text> <paragraph num="A."> <text>Private pool, except for a private pool defined as a limited public-use pool in Regulation .05B of this chapter;</text> </paragraph> <paragraph num="B."> <text>Private spa;</text> </paragraph> <paragraph num="C."> <text>Pool or spa that is completely emptied of water, disinfected, and refilled with water between each use and that is intended for use or used by a single individual during each use; or</text> </paragraph> <paragraph num="D."> <text>Pool or a spa at a bed and breakfast, if the bed and breakfast facility has eight or fewer guest rooms.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Previously Constructed Pools and Spas."> <paragraph num="A."> <text>Except as provided in §C of this regulation, the owner of a pool or spa that was constructed before February 10, 1997 is exempt from bringing the pool or spa into compliance with:</text> <paragraph num="(1)"> <text>Regulations .13C, .14A(3), .17C, .18A(3), .22, .24, and .35 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Notwithstanding any exemption set forth at §A(1) of this regulation, the diving area dimensions of Regulation .27B of this chapter if the diving area is in compliance with American National Standard for Public Swimming Pools.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except for Regulation .28 of this chapter, the owner of a pool or spa that was constructed before February 10, 1997:</text> <paragraph num="(1)"> <text>Shall maintain the pool or spa, including appurtenant structures and equipment as originally constructed; and</text> </paragraph> <paragraph num="(2)"> <text>May complete a repair according to Regulation .06P that restores the pool or spa to its original condition before damage or deterioration without the component complying with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For a pool or spa that was constructed before February 10, 1997, the exemptions in §A of this regulation do not apply if:</text> <paragraph num="(1)"> <text>The pool or spa has a condition that jeopardizes the health or safety of the public, in which case the owner shall ensure that the condition is corrected to meet the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>An owner intends to alter the pool or spa, including appurtenant structures and equipment, in which case the owner shall ensure that the alteration complies with the requirements of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>A suction outlet is not in compliance with Regulation .28 of this chapter, in which case the owner shall ensure that the suction outlet is altered to meet the requirements of Regulation .28 of this chapter for suction entrapment prevention.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Documents Incorporated by Reference."> <text>The following documents are incorporated by reference in this chapter:</text> <paragraph num="A."> <text>American National Standard for Public Swimming Pools (ANSI/NSPI-1 2003) except Articles 6.5, 6.5.1, 6.6, 6.6.1, 6.6.2, 6.6.3, 6.8, 6.9.1, 6.9.3, 7.1.6, 7.1.7, 7.1.7.1, 8.1.1, 8.4.2.1, 8.4.2.3, 12.3.1, 12.3.2, 13.2.1, 13.2.3, 15.3, 17.4.1, 17.5.1, 18.6, and 22.2.1, and except that in Appendix E, the term “shall” is substituted for “should” whenever it appears;</text> </paragraph> <paragraph num="B."> <text>American National Standard for Public Spas, (ANSI/NSPI-2 1999), except Articles 7.6 and 7.6.1;</text> </paragraph> <paragraph num="C."> <text>Circulation System Components and Related Materials for Pools, Spas/Hot Tubs (ANSI/NSF Standard-50 1992);</text> </paragraph> <paragraph num="D."> <text>American National Standard for Residential Inground Swimming Pools (ANSI/NSPI-5 1995) including Appendix E, Model Barrier Code for Residential Swimming Pools, Spas, and Hot Tubs;</text> </paragraph> <paragraph num="E."> <text>American National Standard for Aboveground/Onground Residential Swimming Pools (ANSI/NSPI-4 1992); and</text> </paragraph> <paragraph num="F."> <text>15 U.S.C. §8003, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Alteration.</text> <paragraph num="(a)"> <text>“Alteration” means to:</text> <paragraph num="(i)"> <text>Change or modify an equipment room, a bathhouse, a component, or the configuration of a pool or spa;</text> </paragraph> <paragraph num="(ii)"> <text>Move a component from one location or position to another; or</text> </paragraph> <paragraph num="(iii)"> <text>Install a new component.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Alteration” does not include a repair or replacement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Approved” means found by the Secretary to be in satisfactory compliance with applicable statutes and regulations promulgated or enforced by the Secretary.</text> </paragraph> <paragraph num="(3)"> <text>“Barrier” means an uninterrupted obstacle intended to prevent direct access from one point to another surrounding and securing a pool or spa.</text> </paragraph> <paragraph num="(4)"> <text>“Cfm” means cubic feet per minute.</text> </paragraph> <paragraph num="(4-1)"> <text>“Component” means:</text> <paragraph num="(a)"> <text>A piece of pool or spa equipment;</text> </paragraph> <paragraph num="(b)"> <text>A deck;</text> </paragraph> <paragraph num="(c)"> <text>A barrier;</text> </paragraph> <paragraph num="(d)"> <text>One or more skimmers;</text> </paragraph> <paragraph num="(e)"> <text>One or more filters, including piping and valves;</text> </paragraph> <paragraph num="(f)"> <text>A ventilation system;</text> </paragraph> <paragraph num="(g)"> <text>Lighting provided for water, deck, and walkways; or</text> </paragraph> <paragraph num="(h)"> <text>Pipe material for pool or spa water.</text> </paragraph> </paragraph> <paragraph num="(4-2)"> <text>“Critical violation” means a violation that results from a product, practice, circumstance, or event that creates a situation that requires immediate correction or cessation of operation to prevent injury, illness, or death based on the number of potential injuries and the nature, severity, and duration of the anticipated injury or illness, or specifically:</text> <paragraph num="(a)"> <text>Failure to comply with:</text> <paragraph num="(i)"> <text>Regulation .06-1E of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>For a public pool with a lifeguard on duty, Regulation .21 of this chapter, except for §§A(10)(a) and (c)—(e) and B(2);</text> </paragraph> <paragraph num="(iii)"> <text>For a public pool without a lifeguard on duty, Regulation .21 of this chapter, except for §§A(10)(c)—(e) and B(2);</text> </paragraph> <paragraph num="(iv)"> <text>Regulation .25G of this chapter;</text> </paragraph> <paragraph num="(v)"> <text>Regulation .28 of this chapter, except for §H(3)(b), (7), and (8) and I;</text> </paragraph> <paragraph num="(vi)"> <text>Regulation .40B, D, and E of this chapter;</text> </paragraph> <paragraph num="(vii)"> <text>Regulation .43A and B of this chapter;</text> </paragraph> <paragraph num="(viii)"> <text>Regulation .45A(7) of this chapter;</text> </paragraph> <paragraph num="(ix)"> <text>Regulation .48B of this chapter; or</text> </paragraph> <paragraph num="(x)"> <text>Manufacturer’s instructions or directions when adding chemicals to a public pool or spa;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Meeting both of the following conditions at the same time:</text> <paragraph num="(i)"> <text>The flow through a circulation system of a public pool or spa meets the criteria for a major violation as specified in §B(7-1) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>One or more of the water quality parameters meets the criteria for a major violation as specified in §B(7-1) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A pH level in a public pool or spa that is at or:</text> <paragraph num="(i)"> <text>Below 6.8; or</text> </paragraph> <paragraph num="(ii)"> <text>Above 8.2;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A free chlorine level in a:</text> <paragraph num="(i)"> <text>Pool for swimming or diving or a water recreational attraction that is less than 1 ppm;</text> </paragraph> <paragraph num="(ii)"> <text>Wading or therapy pool that is less than 3 ppm; or</text> </paragraph> <paragraph num="(iii)"> <text>Spa that is less than 4 ppm;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A free chlorine level in a public pool or spa that is 11 ppm or greater;</text> </paragraph> <paragraph num="(f)"> <text>A bromine level in a:</text> <paragraph num="(i)"> <text>Pool for swimming or diving or a water recreational attraction that is less than 3 ppm; or</text> </paragraph> <paragraph num="(ii)"> <text>Spa, wading pool, or therapy pool that is less than 4 ppm;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A bromine level in a public pool or spa that is 11 ppm or greater;</text> </paragraph> <paragraph num="(h)"> <text>A temperature in a mechanically heated:</text> <paragraph num="(i)"> <text>Pool above 96°F; or</text> </paragraph> <paragraph num="(ii)"> <text>Spa above 104°F;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Hand feeding of any chemicals while patrons are in the water of a public pool or spa; or</text> </paragraph> <paragraph num="(j)"> <text>Insufficient illumination such that the bottom of the pool or spa is not clearly visible.</text> </paragraph> </paragraph> <paragraph num="(4-3)"> <text>“Full compliance inspection” means an inspection that verifies compliance with this chapter.</text> </paragraph> <paragraph num="(5)"> <text>“Gpm” means gallons per minute.</text> </paragraph> <paragraph num="(5-1)"> <text>“Hand feeding” means adding chemicals to a pool or spa by any means other than an automatic chemical feeder.</text> </paragraph> <paragraph num="(6)"> <text>“Lifeguard” means an individual who is 15 years old or older and who has a valid lifeguard certificate from:</text> <paragraph num="(a)"> <text>The American Red Cross;</text> </paragraph> <paragraph num="(b)"> <text>The Boy Scouts of America, not including a lifeguard merit badge;</text> </paragraph> <paragraph num="(c)"> <text>The Young Men's Christian Association;</text> </paragraph> <paragraph num="(d)"> <text>Ellis and Associates' National Pool and Waterpark Lifeguard Training; or</text> </paragraph> <paragraph num="(e)"> <text>An organization with a lifesaving training program equivalent to that of the American Red Cross.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Limited Public-Use Pool.</text> <paragraph num="(a)"> <text>“Limited public-use pool” means a private pool which is made available for use by:</text> <paragraph num="(i)"> <text>Children in family day care under the care of a family day care provider at a family day care home as defined in COMAR 07.04.01; or</text> </paragraph> <paragraph num="(ii)"> <text>An organized group, agency, or other person for swimming lessons or water safety training.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Limited public-use pool” does not include a pool that is emptied of water, disinfected, and refilled with water between each use.</text> </paragraph> </paragraph> <paragraph num="(7-1)"> <text>“Major violation” means a violation that if not corrected within 24 hours could lead to injury, illness, or death, or specifically:</text> <paragraph num="(a)"> <text>Failure to comply with:</text> <paragraph num="(i)"> <text>Regulation .21B(2) of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Regulation .25 of this chapter, except for §§B(2) and G;</text> </paragraph> <paragraph num="(iii)"> <text>Regulation .28H(3)(b) or I of this chapter;</text> </paragraph> <paragraph num="(iv)"> <text>Regulation .29 of this chapter;</text> </paragraph> <paragraph num="(v)"> <text>Regulation .32A of this chapter;</text> </paragraph> <paragraph num="(vi)"> <text>Regulation .40 of this chapter, except for §§B, D, and E;</text> </paragraph> <paragraph num="(vii)"> <text>Regulation .46 of this chapter; or</text> </paragraph> <paragraph num="(viii)"> <text>Regulation .48A of this chapter;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The flow through a circulation system of a public pool or spa is:</text> <paragraph num="(i)"> <text>At least 10 percent greater than the design capacity of the filter system or associated piping; or</text> </paragraph> <paragraph num="(ii)"> <text>At least 10 percent less than the minimum turnover rate as specified in Regulation .25B;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A pH level in a public pool or spa that is at or:</text> <paragraph num="(i)"> <text>Below 7; or</text> </paragraph> <paragraph num="(ii)"> <text>Above 8;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A free chlorine level in a pool for swimming or diving or a water recreational attraction that is less than 1.5 ppm;</text> </paragraph> <paragraph num="(e)"> <text>A free chlorine level in a public pool or spa that is between 10 ppm and 11 ppm;</text> </paragraph> <paragraph num="(f)"> <text>A bromine level in a public pool or spa that is greater than 8 ppm;</text> </paragraph> <paragraph num="(g)"> <text>Except for a therapy pool, a mechanically heated public pool temperature between 89°F and 96°F;</text> </paragraph> <paragraph num="(h)"> <text>A cyanuric acid level greater than 100 ppm; or</text> </paragraph> <paragraph num="(i)"> <text>A public pool or spa that has a nonfunctioning disinfection system.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Make-up water” means the potable water used to maintain the water level in a pool or a spa.</text> </paragraph> <paragraph num="(9)"> <text>“NSF” means the National Sanitation Foundation International.</text> </paragraph> <paragraph num="(10)"> <text>“NSPI” means the National Spa and Pool Institute.</text> </paragraph> <paragraph num="(11)"> <text>“Operator” means a person who supervises, controls, conducts, or manages the operation of a pool or spa.</text> </paragraph> <paragraph num="(12)"> <text>“Owner” means a person who has a legal interest in a pool or a spa or in the property on which a pool or a spa is or is to be constructed or altered, or the owner's agent.</text> </paragraph> <paragraph num="(13)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(14)"> <text>“PHMB” means polyiminoimidocarbonyliminoimidocarbonyliminohexamethylene hydrochloride.</text> </paragraph> <paragraph num="(15)"> <text>“Pool” means an artificial enclosure of water that is used for the immersion of the human body for recreation, therapy, or exercise, including a structure that is installed in the ground, above ground, outside, or in a building or portable structure.</text> </paragraph> <paragraph num="(16)"> <text>“Ppm” means parts per million.</text> </paragraph> <paragraph num="(17)"> <text>Private Pool and Private Spa.</text> <paragraph num="(a)"> <text>“Private pool” and “private spa” mean a pool or spa that is:</text> <paragraph num="(i)"> <text>Not open to the public;</text> </paragraph> <paragraph num="(ii)"> <text>On a property on which not more than four private residences are located; and</text> </paragraph> <paragraph num="(iii)"> <text>Used exclusively by the residents of the property and nonpaying individuals invited to use the pool or spa by a resident.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Private pool” and “private spa” include a pool or spa at a private residence used for short-term rentals including weekly, monthly, or seasonal rentals.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Public Pool and Public Spa.</text> <paragraph num="(a)"> <text>“Public pool” and “public spa” mean a pool or spa that is not a private pool or spa.</text> </paragraph> <paragraph num="(b)"> <text>“Public pool” includes a:</text> <paragraph num="(i)"> <text>Limited public-use pool, as defined in §B(7) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Recreational pool as defined in §B(19) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Semipublic pool, as defined in §B(23) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Public spa” includes a semipublic spa, as defined in §B(23) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Recreational pool” means a pool that:</text> <paragraph num="(a)"> <text>Is not a limited public-use pool, private pool, or semipublic pool, as defined in §B(7), (17), and (23) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Is provided as the owner's primary business or the facility's primary purpose, for example, a swim club or similar facility;</text> </paragraph> <paragraph num="(c)"> <text>Is open for general admission to the public;</text> </paragraph> <paragraph num="(d)"> <text>Is available to an individual paying a fee for use of the pool;</text> </paragraph> <paragraph num="(e)"> <text>Is equipped with a sliding board, diving platform, water slide, water flume, or water recreational play equipment that is built into or attached to the pool structure;</text> </paragraph> <paragraph num="(f)"> <text>Is provided by, or used by a:</text> <paragraph num="(i)"> <text>Youth camp;</text> </paragraph> <paragraph num="(ii)"> <text>College, university, or school;</text> </paragraph> <paragraph num="(iii)"> <text>Municipality;</text> </paragraph> <paragraph num="(iv)"> <text>Water park, amusement park, or water recreational attraction as defined in §B(34) of this regulation; or</text> </paragraph> <paragraph num="(v)"> <text>An apartment complex, housing subdivision, or mobile home park with more than ten units, except as provided in §B(23)(a)(v) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Is used more than 4 times a week for swimming lessons, water safety instruction, or swimming competition.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Repair.</text> <paragraph num="(a)"> <text>“Repair” means substituting a component having the same make and model as the previously approved component for the previously approved component.</text> </paragraph> <paragraph num="(b)"> <text>“Repair” does not include:</text> <paragraph num="(i)"> <text>Replacements;</text> </paragraph> <paragraph num="(ii)"> <text>Alterations;</text> </paragraph> <paragraph num="(iii)"> <text>Installation of additional equipment; or</text> </paragraph> <paragraph num="(iv)"> <text>Substitutions involving a component which does not meet the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20-1)"> <text>Replacement.</text> <paragraph num="(a)"> <text>“Replacement” means substituting a component, which has a different make or model but has the same operating characteristics and certifications as the previously approved component, for the previously approved component.</text> </paragraph> <paragraph num="(b)"> <text>“Replacement” does not include:</text> <paragraph num="(i)"> <text>Repairs;</text> </paragraph> <paragraph num="(ii)"> <text>Alterations;</text> </paragraph> <paragraph num="(iii)"> <text>Installation of additional equipment; or</text> </paragraph> <paragraph num="(iv)"> <text>Substitutions involving a component which does not meet the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Safety vacuum release system” means a vacuum release system that:</text> <paragraph num="(a)"> <text>Is capable of providing vacuum release at a suction outlet caused by a high vacuum occurrence due to a suction outlet flow blockage; and</text> </paragraph> <paragraph num="(b)"> <text>Complies with 15 U.S.C. §8003.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee, including a local health officer.</text> </paragraph> <paragraph num="(23)"> <text>“Semipublic pool” and “semipublic spa” mean a pool or spa at a facility that:</text> <paragraph num="(a)"> <text>Has pool use or spa use restricted to an individual:</text> <paragraph num="(i)"> <text>Staying at the facility, where the facility is a temporary dwelling, including a hotel, motel, campground, bed and breakfast having nine or more guest rooms, or similar temporary dwelling;</text> </paragraph> <paragraph num="(ii)"> <text>Holding membership at the facility, where the facility is an adult health club, retirement community, marina, condominium, or similar facility;</text> </paragraph> <paragraph num="(iii)"> <text>Residing at an apartment complex, housing subdivision, or mobile home park with ten units or less;</text> </paragraph> <paragraph num="(iv)"> <text>Receiving treatment at a physical therapy center pool, or spa, where the pool or spa is used for providing therapy; or</text> </paragraph> <paragraph num="(v)"> <text>Who is the owner or an owner of the pool or spa; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has a pool or spa that is not:</text> <paragraph num="(i)"> <text>Open for admission to the general public, except as provided in §B(23)(a) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Available to an individual upon the payment of a fee for the use of the pool and spa;</text> </paragraph> <paragraph num="(iii)"> <text>A limited public-use pool, a private pool, a private spa, or a recreational pool, as defined in §B(7), (17), and (18) of this regulation;</text> </paragraph> <paragraph num="(iv)"> <text>Equipped with a sliding board, diving platform, water slide, water flume, or water recreational play equipment that is built into or attached to the pool structure; and</text> </paragraph> <paragraph num="(v)"> <text>At a bed and breakfast that has eight or fewer guest rooms.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Shallow” means 5 feet or less in depth.</text> </paragraph> <paragraph num="(25)"> <text>“Spa” means a pool, hot tub, or whirlpool that is:</text> <paragraph num="(a)"> <text>Primarily designed for relaxation or therapeutic use and not for swimming;</text> </paragraph> <paragraph num="(b)"> <text>Not more than 4 feet in depth;</text> </paragraph> <paragraph num="(c)"> <text>Equipped with built-in seats or benches; and</text> </paragraph> <paragraph num="(d)"> <text>Usually equipped with hydrotherapy jets, heated water, an air injection system, or some combination of these features.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Spray pool” means a shallow pool into which treated water is sprayed but not allowed to accumulate.</text> </paragraph> <paragraph num="(27)"> <text>“Swimming pool slide” means a device less than 10 feet in height that an individual may use to enter a pool by sliding down an inclined plane.</text> </paragraph> <paragraph num="(28)"> <text>“Swim spa” means a spa designed to create a current of water against which an individual may swim for exercise or therapy.</text> </paragraph> <paragraph num="(29)"> <text>“Therapy pool” means a pool that is exclusively used in the physical treatment of a disease, injury, or disorder.</text> </paragraph> <paragraph num="(30)"> <text>“Total dynamic head” means the hydraulic calculation of the resistance to flow in a circulation system based on the Hazen-Williams formula in Regulation .25C(1)(a) of this chapter.</text> </paragraph> <paragraph num="(31)"> <text>“Tube ride” means a pool designed to move an individual on a tube, raft, or other floating support along a channel filled with water.</text> </paragraph> <paragraph num="(32)"> <text>“Turnover rate” means the time required to circulate a quantity of water equal to the pool or spa volume.</text> </paragraph> <paragraph num="(33)"> <text>“Unblockable drain” means a drain of any size and shape that:</text> <paragraph num="(a)"> <text>A human body cannot sufficiently block to create a suction entrapment hazard;</text> </paragraph> <paragraph num="(b)"> <text>Has the minimum dimensions of 18 inches by 23 inches; and</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“User load” means the maximum number of individuals allowed in a pool or spa, as determined by the Secretary, for sanitary purposes, based on the water surface area and water depths.</text> </paragraph> <paragraph num="(35)"> <text>“Wading pool” means a pool with a water depth of 24 inches or less that is intended for use by children.</text> </paragraph> <paragraph num="(36)"> <text>Water Recreational Attraction.</text> <paragraph num="(a)"> <text>“Water recreational attraction” means a pool with special water circulation and operational features or unconventional design and operational features which provide patron recreational activity different from that associated with a conventional swimming pool, and which purposefully involves total or partial immersion in the water.</text> </paragraph> <paragraph num="(b)"> <text>“Water recreational attraction” includes but is not limited to a:</text> <paragraph num="(i)"> <text>Shallow water pool with permanently installed water play equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Spray pool;</text> </paragraph> <paragraph num="(iii)"> <text>Tube ride;</text> </paragraph> <paragraph num="(iv)"> <text>Water slide; and</text> </paragraph> <paragraph num="(v)"> <text>Wave pool.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Water recreational attraction” does not include a pool with limited water features such as a deck-mounted sliding board or a raindrop feature.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Water slide” means a water-contact amusement ride when the height of the slide is 10 feet or more.</text> </paragraph> <paragraph num="(38)"> <text>“Wave pool” means a pool designed with mechanical or hydraulic apparatus to generate waves in the pool.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Construction and Alteration Permits."> <paragraph num="A."> <text>An owner who intends to construct or alter a public pool or spa shall obtain a construction or alteration permit from the Secretary before beginning the construction or alteration.</text> </paragraph> <paragraph num="B."> <text>An owner may not construct or alter a recreational pool, semipublic pool, or public spa without a construction or alteration permit.</text> </paragraph> <paragraph num="C."> <text>To obtain a construction or alteration permit, an owner shall submit to the Secretary:</text> <paragraph num="(1)"> <text>An application for a construction or alteration permit on an application form provided by the Secretary that includes:</text> <paragraph num="(a)"> <text>The full names and addresses of the owner and authorized agents of the owner who may act on the owner’s behalf during the construction or alteration of the pool or spa;</text> </paragraph> <paragraph num="(b)"> <text>A statement saying “I hereby acknowledge that all items either listed or shown in these plans and specifications as not in contract, by others, or equivalent, are my responsibility. I also realize that this entire project must be completed in accordance with the approved plans and specifications and all conditions listed in the construction or alteration permit and meet the requirements of this chapter prior to the issuance of an operating permit by the Secretary”; and</text> </paragraph> <paragraph num="(c)"> <text>The owner’s signature, which:</text> <paragraph num="(i)"> <text>Indicates the owner has supplied the correct information on and with the application; and</text> </paragraph> <paragraph num="(ii)"> <text>Is in agreement with the statement set forth in §C(1)(b) of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Plans and specifications for the construction or alteration which:</text> <paragraph num="(a)"> <text>Are prepared by a licensed or certified professional engineer, architect, draftsman, or a person with extensive experience in the design of pools and spas;</text> </paragraph> <paragraph num="(b)"> <text>Are drawn:</text> <paragraph num="(i)"> <text>To scale;</text> </paragraph> <paragraph num="(ii)"> <text>In a professional and accurate manner; and</text> </paragraph> <paragraph num="(iii)"> <text>With sufficient clarity and detailed dimensions to show the nature and character of the work to be performed;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Include specific information on the quality or performance of the material or equipment when necessary to establish conformance with this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Are supplied:</text> <paragraph num="(i)"> <text>In triplicate as physical documents; or</text> </paragraph> <paragraph num="(ii)"> <text>As electronic documents; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The application review fee required by COMAR 10.01.17.02.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except as provided in §E of this regulation, an owner shall ensure that the plans and specifications required by §C of this regulation include the following:</text> <paragraph num="(1)"> <text>Site plan with contours;</text> </paragraph> <paragraph num="(2)"> <text>Building plan;</text> </paragraph> <paragraph num="(3)"> <text>Pool or spa layout plan, sectional views, and appurtenant equipment;</text> </paragraph> <paragraph num="(4)"> <text>Pool or spa piping layout plan;</text> </paragraph> <paragraph num="(5)"> <text>Deck and barrier plan;</text> </paragraph> <paragraph num="(6)"> <text>Filter room layout plan with the location of equipment and piping;</text> </paragraph> <paragraph num="(7)"> <text>Ventilation plan;</text> </paragraph> <paragraph num="(8)"> <text>Bathhouse plan;</text> </paragraph> <paragraph num="(9)"> <text>Lighting plan;</text> </paragraph> <paragraph num="(10)"> <text>Potable water supply plumbing diagram;</text> </paragraph> <paragraph num="(11)"> <text>Waste disposal plumbing diagram;</text> </paragraph> <paragraph num="(12)"> <text>Finish schedules;</text> </paragraph> <paragraph num="(13)"> <text>Equipment and material specifications;</text> </paragraph> <paragraph num="(14)"> <text>Head loss calculations;</text> </paragraph> <paragraph num="(15)"> <text>Pump performance curve;</text> </paragraph> <paragraph num="(16)"> <text>Waste water disposal site;</text> </paragraph> <paragraph num="(17)"> <text>Chemical storage plan; and</text> </paragraph> <paragraph num="(18)"> <text>Any information, including material samples, necessary to determine if the plans and specifications comply with criteria set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An owner shall ensure that, for an alteration, the plans and specifications required by §C of this regulation include the information that pertains to the alteration.</text> </paragraph> <paragraph num="F."> <text>Before beginning construction or alteration work, an owner shall obtain:</text> <paragraph num="(1)"> <text>Necessary local zoning approval;</text> </paragraph> <paragraph num="(2)"> <text>Building permits;</text> </paragraph> <paragraph num="(3)"> <text>Electrical permits;</text> </paragraph> <paragraph num="(4)"> <text>Plumbing permits; and</text> </paragraph> <paragraph num="(5)"> <text>Other applicable local permits.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The local county health officer may not approve a local building permit for, or that includes, construction or alteration of a recreational pool, semipublic pool, or public spa until the plans and specifications for construction or alteration of a public pool or spa have been approved by the Secretary.</text> </paragraph> <paragraph num="H."> <text>The Secretary shall review the plans and application for a construction or alteration permit within 30 business days of receipt of the application.</text> </paragraph> <paragraph num="I."> <text>If plans are submitted that are:</text> <paragraph num="(1)"> <text>Not in compliance with the requirements of this chapter, the Secretary shall:</text> <paragraph num="(a)"> <text>Notify the owner of the deficiencies in the application;</text> </paragraph> <paragraph num="(b)"> <text>Deny the application if additional information to correct the deficiencies in the application is not received during the resubmittal window; or</text> </paragraph> <paragraph num="(c)"> <text>Allow the owner 30 business days to resubmit information to correct the deficiencies before denying the application according to §I(1)(b) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In compliance with the requirements of this chapter, the Secretary shall approve the plans and issue a construction or alteration permit, which is valid for:</text> <paragraph num="(a)"> <text>The start of the construction or alteration for 1 year from the date of issue; and</text> </paragraph> <paragraph num="(b)"> <text>1 additional year from the date construction or alteration begins.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>If the Secretary denies the issuance of a construction or alteration permit, an owner shall reapply for a new construction or alteration permit according to §C of this regulation and pay the applicable fees.</text> </paragraph> <paragraph num="K."> <text>An owner may not deviate from the approved plans and specifications for construction or alteration at a recreational pool, semipublic pool, or public spa unless:</text> <paragraph num="(1)"> <text>Revised plans are submitted through the application review process in §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The owner pays the applicable fees; and</text> </paragraph> <paragraph num="(3)"> <text>The Secretary issues a construction or alteration permit for the revised work.</text> </paragraph> </paragraph> <paragraph num="L."> <text>If a recreational pool, semipublic pool, or public spa is not being constructed or altered in accordance with the approved plans, the Secretary may revoke the construction or alteration permit and the owner shall immediately cease construction or alteration.</text> </paragraph> <paragraph num="M."> <text>If the Secretary denies the issuance of a construction or alteration permit as set forth in §I of this regulation, or revokes a construction or alteration permit as set forth in §L of this regulation, the Secretary shall notify the owner in writing:</text> <paragraph num="(1)"> <text>Of the reason or reasons for the denial or revocation;</text> </paragraph> <paragraph num="(2)"> <text>That the owner may request from the Secretary an opportunity for a hearing on the denial or revocation pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, if the owner wishes to contest the denial or revocation; and</text> </paragraph> <paragraph num="(3)"> <text>That to preserve the right to a hearing, the owner shall contact the Department within 10 business days of the receipt of the notice of denial or revocation.</text> </paragraph> </paragraph> <paragraph num="N."> <text>An owner shall ensure that a construction or alteration permit is posted in a conspicuous location at the site of construction or alteration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="Replacements."> <paragraph num="A."> <text>An owner may replace a component at a recreational pool, semipublic pool, or public spa before obtaining approval from the Secretary.</text> </paragraph> <paragraph num="B."> <text>Before replacing a component at a recreational pool, semipublic pool, or public spa, an owner shall obtain necessary:</text> <paragraph num="(1)"> <text>Local zoning approval;</text> </paragraph> <paragraph num="(2)"> <text>Building permits;</text> </paragraph> <paragraph num="(3)"> <text>Electrical permits;</text> </paragraph> <paragraph num="(4)"> <text>Plumbing permits; and</text> </paragraph> <paragraph num="(5)"> <text>Other applicable local permits.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The local health department may approve a local building permit for, or that includes, replacement of a component at a recreational pool, semipublic pool, or public spa before the replacement application is approved by the Secretary.</text> </paragraph> <paragraph num="D."> <text>An owner shall submit, on a form provided by the Secretary, an application for the replacement of a component at a recreational pool, semipublic pool, or public spa within 10 business days of completing the replacement.</text> </paragraph> <paragraph num="E."> <text>If, during an inspection by the local health department, it is determined that a component has been replaced and the owner failed to submit the form required in §D of this regulation, the owner shall submit the required form to the Department within 10 business days of the local health department’s inspection.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall inspect the replacement of a component at a recreational pool, semipublic pool, or public spa within 30 business days of receipt of the application.</text> </paragraph> <paragraph num="G."> <text>If, during the inspection, the replacement of a component at a recreational pool, semipublic pool, or public spa is in compliance with the requirements of this chapter, the Secretary shall:</text> <paragraph num="(1)"> <text>Provide the owner a copy of the inspection report; and</text> </paragraph> <paragraph num="(2)"> <text>Issue an approval letter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If, during the inspection, the replacement of a component at a recreational pool, semipublic pool, or public spa is not in compliance with the requirements of this chapter, the Secretary shall:</text> <paragraph num="(1)"> <text>Deny the replacement application; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the owner:</text> <paragraph num="(a)"> <text>Of the reason or reasons for the denial;</text> </paragraph> <paragraph num="(b)"> <text>That the owner may request from the Secretary an opportunity for a hearing on the denial pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, if the owner wishes to contest the denial;</text> </paragraph> <paragraph num="(c)"> <text>That to preserve the right to a hearing, the owner shall contact the Department within 10 business days of the receipt of the notice of denial; and</text> </paragraph> <paragraph num="(d)"> <text>That the owner shall cease operation of a recreational pool, semipublic pool, or public spa if the component is essential to operation or cease operation of the replaced component, where the replacement of a component was found to violate this chapter until:</text> <paragraph num="(i)"> <text>The violation is corrected;</text> </paragraph> <paragraph num="(ii)"> <text>A new replacement application and applicable fee is submitted to the Secretary; and</text> </paragraph> <paragraph num="(iii)"> <text>The Secretary inspects and approves the replacement of the component.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Repairs."> <text>An owner may make a repair to a recreational pool, semipublic pool, or public spa in accordance with this chapter without:</text> <paragraph num="A."> <text>Obtaining a construction, alteration, or replacement permit from the Secretary; or</text> </paragraph> <paragraph num="B."> <text>Notifying the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Approval After Construction or Alteration."> <paragraph num="A."> <text>A person may not operate or permit the use of a recreational pool, semipublic pool, or public spa that has not received written approval from the Secretary after its construction or alteration.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall conduct an inspection to ensure that a recreational pool, semipublic pool, or public spa is constructed or altered according to the approved plans and meets the requirements of this chapter, and shall:</text> <paragraph num="(1)"> <text>Grant written approval for the pool or spa if:</text> <paragraph num="(a)"> <text>It was constructed or altered according to the approved plans;</text> </paragraph> <paragraph num="(b)"> <text>It meets the requirements of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>The owner has received local approval for any:</text> <paragraph num="(i)"> <text>Building;</text> </paragraph> <paragraph num="(ii)"> <text>Electrical;</text> </paragraph> <paragraph num="(iii)"> <text>Plumbing; or</text> </paragraph> <paragraph num="(iv)"> <text>Other work that requires a local permit; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Deny approval for the pool or spa if:</text> <paragraph num="(a)"> <text>It was not constructed or altered according to the approved plans;</text> </paragraph> <paragraph num="(b)"> <text>It does not meet the requirements of this chapter; or</text> </paragraph> <paragraph num="(c)"> <text>The owner has not received local approval for any:</text> <paragraph num="(i)"> <text>Building;</text> </paragraph> <paragraph num="(ii)"> <text>Electrical;</text> </paragraph> <paragraph num="(iii)"> <text>Plumbing; or</text> </paragraph> <paragraph num="(iv)"> <text>Other work that requires a local permit.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall grant written approval or deny approval of the completed construction or alteration of a public pool or spa within 15 business days of inspecting.</text> </paragraph> <paragraph num="D."> <text>If minor items that do not affect the health or safety of the public need to be corrected, the Secretary may issue a temporary approval for the pool or spa after construction pending full compliance according to the following conditions:</text> <paragraph num="(1)"> <text>The owner shall fully comply with this chapter by the end of the 30-business-day period in order to obtain written approval of the recreational pool, semipublic pool, or public spa; and</text> </paragraph> <paragraph num="(2)"> <text>If at the end of the 30-business-day period, the Secretary is unable to approve the recreational pool, semipublic pool, or public spa pursuant to §B of this regulation, the Secretary shall disapprove the construction.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Secretary does not grant approval for the pool or spa after it is constructed or altered, the Secretary shall notify the owner in writing:</text> <paragraph num="(1)"> <text>Of the reason or reasons for the disapproval;</text> </paragraph> <paragraph num="(2)"> <text>That the owner may request from the Secretary an opportunity for a hearing on the disapproval pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>That to preserve the right to a hearing, the owner shall submit a written request for a hearing to the Secretary within 10 business days of the receipt of the notice of disapproval; and</text> </paragraph> <paragraph num="(4)"> <text>That the owner shall submit a new plan review application and pay any applicable fees according to Regulation .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Permits for Operation."> <paragraph num="A."> <text>A person may not operate a public pool or spa without an annual operating permit issued by the Secretary, except that in the case of a pool or spa that has received a temporary approval of construction pursuant to Regulation .08D of this chapter, the Secretary may issue a nontransferable 30-calendar-day permit for the temporary operation of the pool or spa.</text> </paragraph> <paragraph num="B."> <text>On an application form provided by the Secretary, an owner shall apply to the Secretary for an annual permit to operate a public pool or spa for:</text> <paragraph num="(1)"> <text>A newly constructed pool or spa, at least 30 business days before the pool or spa is scheduled to open; or</text> </paragraph> <paragraph num="(2)"> <text>An existing pool or spa, 30 business days before the previous permit expires.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary shall:</text> <paragraph num="(1)"> <text>Issue, for each pool or spa, a nontransferable permit to an owner whose public pool or spa is in compliance with this chapter as verified by a full compliance inspection completed within the 12 months prior to the expiration of the current operating permit; and</text> </paragraph> <paragraph num="(2)"> <text>When a public pool or spa does not meet the requirements of this chapter, deny the permit within 30 business days of the receipt of the application by notifying the owner in writing:</text> <paragraph num="(a)"> <text>Of the reason or reasons for the denial;</text> </paragraph> <paragraph num="(b)"> <text>Of the action to be taken in order for the pool or spa to qualify for a permit;</text> </paragraph> <paragraph num="(c)"> <text>That the owner may request from the Secretary an opportunity for a hearing on this denial pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>That to preserve the right to a hearing, the person shall contact the Secretary within 10 business days of the receipt of the notice of denial.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A person who operates a public pool or spa shall post the operating permit in a conspicuous place near the entrance to the pool or spa.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Suspension or Revocation of an Operating Permit."> <paragraph num="A."> <text>Suspension.</text> <paragraph num="(1)"> <text>The Secretary may:</text> <paragraph num="(a)"> <text>Suspend an operating permit if an owner or operator violates a requirement of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Summarily suspend an operating permit and close a public pool or spa when protection of the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may summarily suspend an operating permit pursuant to §A(1)(b) of this regulation for a:</text> <paragraph num="(a)"> <text>Critical violation not corrected immediately; or</text> </paragraph> <paragraph num="(b)"> <text>Major violation not corrected within 24 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Revocation and Permitting After Revocation.</text> <paragraph num="(1)"> <text>The Secretary may revoke a permit for:</text> <paragraph num="(a)"> <text>Consecutive repeat violations of a requirement of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>An owner whose operating permit was revoked within the past 2 years, upon determination that the owner is in violation of the same requirement of this chapter that resulted in the previous revocation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may issue an operating permit to an owner whose operating permit was revoked:</text> <paragraph num="(a)"> <text>After the 6-month waiting period from the date of revocation has expired; and</text> </paragraph> <paragraph num="(b)"> <text>When the owner:</text> <paragraph num="(i)"> <text>Corrects the violations;</text> </paragraph> <paragraph num="(ii)"> <text>Applies for an operating permit;</text> </paragraph> <paragraph num="(iii)"> <text>Pays the applicable fees; and</text> </paragraph> <paragraph num="(iv)"> <text>Complies with all applicable provisions of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Hearing.</text> <paragraph num="(1)"> <text>In the case of the summary suspension of a permit pursuant to §A(1)(b) of this regulation, the Secretary shall provide a person with written notice of the violation and an opportunity for a hearing pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>In the case of a permit suspension pursuant to §A(1)(a) of this regulation or a permit revocation pursuant to §B of this regulation, before taking action against a person, the Secretary shall provide written notice of the facts that warrant the suspension or revocation and an opportunity for a hearing before suspending or revoking the permit.</text> </paragraph> <paragraph num="(3)"> <text>To preserve a right to a hearing, a person shall contact the Secretary within 10 business days of the receipt of the notice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Inspections and Right of Entry."> <paragraph num="A."> <text>The Secretary may enter, at a reasonable time, public or private property for inspecting and investigating conditions relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="B."> <text>A person may not deny or interfere with the Secretary's entry onto public or private property to inspect or to take enforcement action pursuant to this chapter.</text> </paragraph> <paragraph num="C."> <text>The Secretary shall conduct:</text> <paragraph num="(1)"> <text>A full compliance inspection of the public pool or spa relative to the enforcement of this chapter at least once every 12 months; and</text> </paragraph> <paragraph num="(2)"> <text>An inspection of the public pool or spa relative to the enforcement of this chapter at least once every 90 business days except:</text> <paragraph num="(a)"> <text>If a critical violation exists, an inspection is required at least every 30 business days; or</text> </paragraph> <paragraph num="(b)"> <text>If no critical violations were found on the three previous consecutive inspections, only the full compliance inspection prescribed in §C(1) of this regulation is required.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Conflict of Regulations."> <text>An owner shall comply with:</text> <paragraph num="A."> <text>The provision that establishes a higher standard for the promotion and protection of public health and safety if a provision of this chapter is in conflict with a local code, ordinance, statute, or other regulation; and</text> </paragraph> <paragraph num="B."> <text>This chapter if there is a conflict between this chapter and the provisions of American National Standard for Public Swimming Pools or the American National Standard for Public Spas.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Standards for Recreational and Semipublic Pools."> <text>An owner shall ensure that an existing, newly built, or altered recreational or semipublic pool is in compliance with:</text> <paragraph num="A."> <text>This chapter;</text> </paragraph> <paragraph num="B."> <text>Applicable State and local codes; and</text> </paragraph> <paragraph num="C."> <text>The American National Standard for Public Swimming Pools.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Standards for Public Spas."> <paragraph num="A."> <text>An owner shall ensure that an existing, newly built, or altered public spa is in compliance with:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>Applicable State and local codes; and</text> </paragraph> <paragraph num="(3)"> <text>The American National Standard for Public Spas.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner shall ensure that a swim spa has:</text> <paragraph num="(1)"> <text>Clearly identified controls for the swim jets; and</text> </paragraph> <paragraph num="(2)"> <text>A shut-off switch for the swim jets that is accessible from within the swim spa.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An owner shall ensure that a spa hydrojet circulation system:</text> <paragraph num="(1)"> <text>Is not connected to a spa filtration system; and</text> </paragraph> <paragraph num="(2)"> <text>Has a shut-off switch.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Standards for Limited Public-Use Pools."> <paragraph num="A."> <text>An owner of a limited public-use pool shall ensure that:</text> <paragraph num="(1)"> <text>The construction of the pool is in compliance with:</text> <paragraph num="(a)"> <text>The American National Standard for Residential Inground Swimming Pools, if the pool is constructed in the ground or as a permanent structure in a building; or</text> </paragraph> <paragraph num="(b)"> <text>The American National Standard for Aboveground/Onground Residential Swimming Pools, if the pool is removable and located above ground or on ground;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The barrier around the pool is in compliance with:</text> <paragraph num="(a)"> <text>Appendix E of the American National Standard for Residential Inground Swimming Pools, if the pool is used by a family day care home; or</text> </paragraph> <paragraph num="(b)"> <text>Local building codes, if the pool is donated for use by an organized group, agency, or other person for swimming lessons or water safety training;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The pool and the operation of the pool are in compliance with Regulations .01—.05, .09—.12, .15, .19—.20, .24, .25B(3), .28, .31, .34, .37—.41, and .43—.54 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>The circulation system includes a properly sized flow meter to indicate the rate of flow;</text> </paragraph> <paragraph num="(5)"> <text>The dimensions of a diving area are:</text> <paragraph num="(a)"> <text>In conformance with Regulation .27B of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>If the diving area does not conform to Regulation .27B, the diving equipment is restricted from use by temporary barriers or is removed;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A suction outlet is in compliance with Regulation .28 of this chapter to prevent suction entrapment;</text> </paragraph> <paragraph num="(7)"> <text>The following safety equipment is immediately available:</text> <paragraph num="(a)"> <text>A first aid kit as recommended by the American Red Cross;</text> </paragraph> <paragraph num="(b)"> <text>A mouth piece for CPR;</text> </paragraph> <paragraph num="(c)"> <text>Disposable latex plastic gloves;</text> </paragraph> <paragraph num="(d)"> <text>A light, strong rescue pole with a rescue hook designed for lifesaving;</text> </paragraph> <paragraph num="(e)"> <text>A rescue tube for each lifeguard, if a lifeguard is on duty; and</text> </paragraph> <paragraph num="(f)"> <text>A telephone for reaching 911 emergency service and the telephone location posted with the:</text> <paragraph num="(i)"> <text>Name and phone number of the nearest available police, fire, and ambulance or rescue unit;</text> </paragraph> <paragraph num="(ii)"> <text>Name of the facility or the name of the owner of the property where the pool is located; and</text> </paragraph> <paragraph num="(iii)"> <text>Location of the pool;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>An individual certified in cardiopulmonary resuscitation (CPR) for the professional rescuer and certified in first aid is on duty while the pool is in use;</text> </paragraph> <paragraph num="(9)"> <text>Pool chemicals are used and stored in accordance with manufacturers' directions and the material safety data sheet for a particular chemical; and</text> </paragraph> <paragraph num="(10)"> <text>The pool has backflow protection:</text> <paragraph num="(a)"> <text>For a potable water supply, in conformance with COMAR 09.20.01; and</text> </paragraph> <paragraph num="(b)"> <text>For waste water, in conformance with COMAR 09.20.01.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An owner of a family day care home using a limited public-use pool shall ensure that water safety supervision is provided in compliance with COMAR 07.04.01.22.</text> </paragraph> <paragraph num="C."> <text>An organized group, agency, or other person using a limited public-use pool for swimming lessons or water safety training shall ensure that water safety supervision is provided as follows:</text> <paragraph num="(1)"> <text>An individual certified as an American Red Cross Water Safety Instructor, or with an equivalent certification that has been approved by the Secretary, is on-site to conduct swimming lessons or water safety training; and</text> </paragraph> <paragraph num="(2)"> <text>Aquatic rescue staff are on-site as follows:</text> <paragraph num="(a)"> <text>An individual certified in American Red Cross Basic Water Rescue, or with equivalent certification as approved by the Secretary, for each ten bathers, or fraction of ten bathers, if the pool:</text> <paragraph num="(i)"> <text>Is no more than 3 1/2 feet in depth at the shallow end of the swimming area;</text> </paragraph> <paragraph num="(ii)"> <text>Is no more than 5 feet in depth at the deepest point;</text> </paragraph> <paragraph num="(iii)"> <text>Has a rescue pole that can be practically used to reach beyond the midpoint of the pool and can be used within the pool enclosure without an obstruction, such as a wall or tall fencing, that restricts the use of the pole; and</text> </paragraph> <paragraph num="(iv)"> <text>Has no diving board, sliding board, or recreational play equipment, or the equipment is blocked off to restrict use; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual certified in American Red Cross Lifeguarding, or with an equivalent certification as approved by the Secretary, for each 25 bathers, or fraction of 25 bathers, if the pool:</text> <paragraph num="(i)"> <text>Is more than 3 1/2 feet in depth at the shallow end of the swimming area;</text> </paragraph> <paragraph num="(ii)"> <text>Has an area more than 5 feet in depth at the deepest point;</text> </paragraph> <paragraph num="(iii)"> <text>Does not have a rescue pole that can be practically used to reach beyond the midpoint of the pool, or an obstruction, such as a wall or tall fencing, exists within the pool enclosure that restricts the use of the pole; or</text> </paragraph> <paragraph num="(iv)"> <text>Has a diving board, a sliding board, or recreational play equipment that is not blocked off to restrict use.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>This regulation does not prohibit an organized group, agency, or other person using a limited public-use pool for swimming lessons or water safety training from providing the portable safety equipment, aquatic safety personnel, pool operator, test kits, or other materials required for a limited public-use pool, to meet the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Standards for Water Recreational Attractions."> <text>An owner shall ensure that:</text> <paragraph num="A."> <text>A water recreational attraction:</text> <paragraph num="(1)"> <text>Is designed to eliminate or minimize safety hazards such as entrapment, slipping, abrasions, cuts, falls, trip hazards, impact injury, and drowning;</text> </paragraph> <paragraph num="(2)"> <text>Is in compliance with applicable State and local codes and this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Has a communication system for use by supervisors, watchers, and lifeguards;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Plans for supervision, attendants, and lifeguards are submitted as part of the construction plans and include safety personnel at all potentially hazardous activity areas;</text> </paragraph> <paragraph num="C."> <text>A swimming pool slide is in conformance with the American National Standard for Public Swimming Pools and has:</text> <paragraph num="(1)"> <text>Attachments that firmly anchor the swimming pool slide;</text> </paragraph> <paragraph num="(2)"> <text>At the end of the slide a minimum water depth of:</text> <paragraph num="(a)"> <text>4 feet, or a water depth in conformance with the manufacturer's installation instructions, for a distance of 10 feet along the slide centerline for a swimming pool slide that does not slow an individual's entry into the water or that drops the individual into the water; or</text> </paragraph> <paragraph num="(b)"> <text>6 inches, or a water depth in conformance with the manufacturer's installation instructions, for a swimming pool slide designed to slow an individual to a near stop at the end of the slide;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A cushioned landing mat below the end of a swimming pool slide if there is a potential for impact or abrasion injury;</text> </paragraph> <paragraph num="(4)"> <text>A centerline distance from the end of a slide to a wall, lifeline, transition point, centerline from another slide, or obstruction that eliminates the potential for an individual using the slide to strike a wall, lifeline, transition point, an individual using another slide, or an obstruction;</text> </paragraph> <paragraph num="(5)"> <text>A minimum side distance of 4 feet from the centerline of a slide to a wall, lifeline, transition point, or obstruction;</text> </paragraph> <paragraph num="(6)"> <text>A design that eliminates the potential for an individual to strike the pool deck or coping while traveling down the swimming pool slide;</text> </paragraph> <paragraph num="(7)"> <text>A slide end that extends beyond the pool wall, deck, and coping; and</text> </paragraph> <paragraph num="(8)"> <text>A minimum side distance of 12 feet between the centerline of a slide and a diving board, diving platform, or starting block;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A water slide:</text> <paragraph num="(1)"> <text>Complies with the conditions set forth at COMAR 09.12.63 as evidenced by written documentation from:</text> <paragraph num="(a)"> <text>The Maryland Department of Labor; or</text> </paragraph> <paragraph num="(b)"> <text>If the water slide is not subject to regulation by the Maryland Department of Labor, a registered professional engineer who certifies that the water slide meets the design criteria set forth at COMAR 09.12.63.07; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Exits to a plunge pool or slide runout;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A wave pool is provided with an emergency shut-off switch at each guard station;</text> </paragraph> <paragraph num="F."> <text>A tube ride has designated entry and exit points;</text> </paragraph> <paragraph num="G."> <text>A spray pool has:</text> <paragraph num="(1)"> <text>A bottom that slopes from 1/4 inch per foot to 5/8 inch per foot to a drain with grate;</text> </paragraph> <paragraph num="(2)"> <text>No standing water; and</text> </paragraph> <paragraph num="(3)"> <text>No obstruction less than 4 feet in height;</text> </paragraph> </paragraph> <paragraph num="H."> <text>A single-lane pool used for swimming laps has:</text> <paragraph num="(1)"> <text>A minimum width of 7 1/2 feet; and</text> </paragraph> <paragraph num="(2)"> <text>A sign on the deck that reads, “Warning: No Diving—Shallow Water” if the water depth is 5 feet or less;</text> </paragraph> </paragraph> <paragraph num="I."> <text>A decorative fountain or waterfall installed in or connected to a pool or spa does not create a health or safety hazard;</text> </paragraph> <paragraph num="J."> <text>A spray fixture, fountain, piece of play equipment, bridge, ramp, stair, float, swing, or other recreational equipment located within a pool or spa:</text> <paragraph num="(1)"> <text>Is designed to eliminate or minimize safety hazards such as entrapment, concealment, slipping, abrasions, cuts, punctures, falls, trip hazards, impact injury, and drowning;</text> </paragraph> <paragraph num="(2)"> <text>Is limited to a shallow water area;</text> </paragraph> <paragraph num="(3)"> <text>Has a color that contrasts with the pool or spa so that the structure is highly visible;</text> </paragraph> <paragraph num="(4)"> <text>Has pipes or support columns that are at least 6 inches in diameter;</text> </paragraph> <paragraph num="(5)"> <text>Is provided with an overhead clearance of at least 7 feet from the pool floor and 4 feet from the water surface where a person may walk under the fixture;</text> </paragraph> <paragraph num="(6)"> <text>Is provided with recirculated, treated pool water for a spray, stream, or other flow of water; and</text> </paragraph> <paragraph num="(7)"> <text>Is installed according to the manufacturer's directions;</text> </paragraph> </paragraph> <paragraph num="K."> <text>The water surface is maintained at a level that allows the surface overflow system to operate properly;</text> </paragraph> <paragraph num="L."> <text>At least two interconnected main drains are installed in the deepest part of a pool and are connected to the filtration system;</text> </paragraph> <paragraph num="M."> <text>A pump reservoir or surge tank is provided for a slide or water feature circulation pump intake and:</text> <paragraph num="(1)"> <text>Is made of concrete or other impervious material with a smooth slip-resistant finish;</text> </paragraph> <paragraph num="(2)"> <text>Has inlets through a weir or a gravity-fed drain with a secure grate;</text> </paragraph> <paragraph num="(3)"> <text>Has a volume equal to 2 minutes of the combined flow of all pumps connected to the reservoir or tank;</text> </paragraph> <paragraph num="(4)"> <text>Is accessible only to authorized individuals;</text> </paragraph> <paragraph num="(5)"> <text>Has pump intakes located in the pump reservoir that are designed to allow cleaning without danger of entrapment; and</text> </paragraph> <paragraph num="(6)"> <text>The water velocity through grate or drain openings does not exceed 2 feet per second;</text> </paragraph> </paragraph> <paragraph num="N."> <text>A slide or water feature circulation pump has a check valve on the discharge side; and</text> </paragraph> <paragraph num="O."> <text>Returns from a filtration system are placed to provide even and positive circulation and to eliminate any dead spots.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Standards for Public Wading Pools."> <text>An owner shall ensure that a public wading pool is in compliance with:</text> <paragraph num="A."> <text>This chapter;</text> </paragraph> <paragraph num="B."> <text>Applicable State and local codes;</text> </paragraph> <paragraph num="C."> <text>The American National Standard for Public Swimming Pools; and</text> </paragraph> <paragraph num="D."> <text>Article 10.6 of the American National Standard for Public Spas.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Standards for Public Therapy Pools."> <text>An owner shall ensure that a public therapy pool:</text> <paragraph num="A."> <text>Is in compliance with:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>Applicable State and local codes; and</text> </paragraph> <paragraph num="(3)"> <text>The American National Standard for Public Swimming Pools;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Has:</text> <paragraph num="(1)"> <text>A deck with a minimum width of 4 feet around at least 50 percent of the therapy pool that provides access to individuals using the therapy pool, not including any ramp, entrance area, or exercise area; and</text> </paragraph> <paragraph num="(2)"> <text>A transition area between a shallow and a deep area that has:</text> <paragraph num="(a)"> <text>A floor slope that does not exceed 1 foot of drop to 3 feet of run; or</text> </paragraph> <paragraph num="(b)"> <text>Steps or ramps with handrails or a swing lift to transfer bathers from a shallow area to a deep area; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Is used only for the purpose of supervised therapy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="User Load."> <paragraph num="A."> <text>The Secretary shall determine the user load, as defined in Regulation .05B(32) of this chapter, based on the following criteria:</text> <paragraph num="(1)"> <text>For a pool and its deck, one individual is allowed for:</text> <paragraph num="(a)"> <text>Every 12 square feet of water surface in shallow areas,</text> </paragraph> <paragraph num="(b)"> <text>Every 15 square feet of water surface in areas exceeding 5 feet of water depth, excluding a diving area, and</text> </paragraph> <paragraph num="(c)"> <text>The 300 square-foot diving area required for each diving board or diving platform;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a spa, one individual is allowed for every 9 square feet of water surface; and</text> </paragraph> <paragraph num="(3)"> <text>For a therapy pool, one individual is allowed for every:</text> <paragraph num="(a)"> <text>Therapy station, or</text> </paragraph> <paragraph num="(b)"> <text>20 square feet of water surface, whichever is less.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An owner shall ensure that the:</text> <paragraph num="(1)"> <text>Number of individuals in a pool or spa and on the required deck area does not exceed the user load as set forth in §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Number of individuals using an enclosed pool or spa area or a spectator area is in conformance with local fire code requirements; and</text> </paragraph> <paragraph num="(3)"> <text>User load of a pool or spa is posted in a conspicuous place at the pool or spa.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Public Pool or Spa Site."> <text>An owner shall ensure that a public pool or spa site:</text> <paragraph num="A."> <text>Drains away from the pool or spa area;</text> </paragraph> <paragraph num="B."> <text>Has water and waste water facilities that conform to the requirements of:</text> <paragraph num="(1)"> <text>COMAR 09.20.01,</text> </paragraph> <paragraph num="(2)"> <text>COMAR 26.04.01—26.04.04, and</text> </paragraph> <paragraph num="(3)"> <text>Local plumbing code requirements;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Has a walkway between a pool or spa and appurtenant buildings such as a bathhouse or equipment room; and</text> </paragraph> <paragraph num="D."> <text>Complies with applicable State and local codes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Barriers."> <paragraph num="A."> <text>Except as set forth in §§B, C, and D of this regulation, an owner shall ensure that a recreational pool, semipublic pool, or public spa, including the required deck area, is completely surrounded by a barrier that complies with the following requirements:</text> <paragraph num="(1)"> <text>The top of the barrier is at least 72 inches above grade measured on the side of the barrier that faces away from the pool or spa;</text> </paragraph> <paragraph num="(2)"> <text>The maximum vertical clearance between grade and the bottom of the barrier is 4 inches measured on the side of the barrier that faces away from the pool or spa;</text> </paragraph> <paragraph num="(3)"> <text>Except when a door or gate that allows access to the pool or spa area enclosed by the barrier is open, an opening in the barrier including in a door or gate does not allow passage of a sphere 4 inches in diameter;</text> </paragraph> <paragraph num="(4)"> <text>Fence pickets have a maximum separation of 4 inches;</text> </paragraph> <paragraph num="(5)"> <text>The barrier discourages climbing by preventing access to nearby structures to simplify climbing over it, such as light poles, site furnishings, overhanging tree limbs, or other obvious footholds or handholds;</text> </paragraph> <paragraph num="(6)"> <text>A barrier with horizontal members less than 45 inches apart measured top to top does not have:</text> <paragraph num="(a)"> <text>Vertical openings greater than 1-3/4 inches in width; or</text> </paragraph> <paragraph num="(b)"> <text>Horizontal members on the outside of the barrier;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The barrier does not have decorative cutouts greater than 1-3/4 inches in width;</text> </paragraph> <paragraph num="(8)"> <text>A chain link fence has a maximum mesh size of 2-1/4 inches;</text> </paragraph> <paragraph num="(9)"> <text>A lattice fence has a maximum mesh size of 1-3/4 inches;</text> </paragraph> <paragraph num="(10)"> <text>Except as provided in §A(11) and (12) of this regulation, a door or gate that allows access to the pool or spa area enclosed by the barrier shall:</text> <paragraph num="(a)"> <text>Have the release to open the door or gate located:</text> <paragraph num="(i)"> <text>At least 54 inches from the floor level; or</text> </paragraph> <paragraph num="(ii)"> <text>Between 34 and 48 inches from the floor level when an electronic or combination mechanical release device is used to release the door or gate;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Be locked to prevent unauthorized entry to the pool or spa area;</text> </paragraph> <paragraph num="(c)"> <text>Open away from the pool or spa area;</text> </paragraph> <paragraph num="(d)"> <text>Have an opening that provides a minimum width of 32 inches between the gate or door stop and the face of the gate or door with the gate or door open 90 degrees; and</text> </paragraph> <paragraph num="(e)"> <text>Comply with Regulation .37 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>A door or gate that allows access to the pool or spa area enclosed by the barrier and is designated as fire egress from a building:</text> <paragraph num="(a)"> <text>May not be included in any facility approved for construction after May 27, 2022; and</text> </paragraph> <paragraph num="(b)"> <text>Is exempt from §A(10)(c) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>A door or gate used exclusively for maintenance or service access is exempt from §A(10)(a) and (c)—(e) of this regulation; and</text> </paragraph> <paragraph num="(13)"> <text>A window that is a part of the barrier may not be able to be opened more than 4 inches.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner shall ensure that a barrier at a semipublic pool or semipublic spa:</text> <paragraph num="(1)"> <text>Has a minimum height of 60 inches; and</text> </paragraph> <paragraph num="(2)"> <text>Has a gate that is self-closing and self-latching.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §D of this regulation, an owner may surround a pool and spa, multiple pools, or multiple spas at one facility with one barrier instead of separate barriers for each pool or spa.</text> </paragraph> <paragraph num="D."> <text>An owner shall ensure that a wading pool or infant pool is separated from a pool or spa by a barrier that has:</text> <paragraph num="(1)"> <text>A minimum height of 36 inches;</text> </paragraph> <paragraph num="(2)"> <text>A maximum 4-inch separation between the deck and the bottom of the barrier;</text> </paragraph> <paragraph num="(3)"> <text>No opening that allows the passage of a sphere 4 inches in diameter; and</text> </paragraph> <paragraph num="(4)"> <text>An entrance gate with a latch.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An owner of a pool or spa with a barrier that includes a door or gate designated as a fire egress from a building shall ensure that whenever a lifeguard is not on duty, the pool or spa is secured:</text> <paragraph num="(1)"> <text>With a cover that has a visible label indicating that it meets ASTM F1346 — 91; or</text> </paragraph> <paragraph num="(2)"> <text>By following procedures per a variance under Regulation .53 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Decks."> <paragraph num="A."> <text>An owner shall ensure that:</text> <paragraph num="(1)"> <text>A deck at a recreational or semipublic pool:</text> <paragraph num="(a)"> <text>Completely surrounds the pool;</text> </paragraph> <paragraph num="(b)"> <text>Is continuous with a minimum unobstructed width of 4 feet and an average width of 6 feet, and</text> </paragraph> <paragraph num="(c)"> <text>Is in conformance with the American National Standard for Public Swimming Pools;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A deck at a public spa is in conformance with the American National Standard for Public Spas;</text> </paragraph> <paragraph num="(3)"> <text>The slope of a deck is away from a pool or a spa, toward points of disposal, and not less than 1/4 inch per foot, or greater than 1/2 inch per foot;</text> </paragraph> <paragraph num="(4)"> <text>The deck has drainage to deck drains or other points of disposal;</text> </paragraph> <paragraph num="(5)"> <text>The deck's surface is slip resistant or nonskid;</text> </paragraph> <paragraph num="(6)"> <text>An expansion joint between the coping and deck is sealed with a durable, watertight sealant;</text> </paragraph> <paragraph num="(7)"> <text>A brick, stone, aggregate, or similar deck surface has a subdeck in the required deck area;</text> </paragraph> <paragraph num="(8)"> <text>A wood deck has a gravel and plastic ground barrier or a concrete subdeck in the required deck area; and</text> </paragraph> <paragraph num="(9)"> <text>The deck does not trap dirt or support or harbor algae.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner may:</text> <paragraph num="(1)"> <text>Include the pool or spa coping in the measurement of the deck width; and</text> </paragraph> <paragraph num="(2)"> <text>Have ladders, handrails, lifeguard stands, structures for use by disabled individuals, and other pool equipment on the deck.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §B(2) of this regulation, an owner may not have light poles, structural supports, decorative fountains, waterfalls, and other obstacles or obstructions within 4 feet of a pool or within the required deck area of a spa.</text> </paragraph> <paragraph num="D."> <text>An owner shall ensure that an anchor for a fixture used to support a backstroke flag, volleyball net, or similar recreational equipment is fitted with a cap or plug that is flush with the deck when the anchor is not in use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Equipment Rooms."> <text>An owner shall ensure that a recreational pool, semipublic pool, or public spa has an equipment room that:</text> <paragraph num="A."> <text>Houses the pool or spa circulation, filtration, and disinfection equipment; and</text> </paragraph> <paragraph num="B."> <text>Has:</text> <paragraph num="(1)"> <text>Weathertight construction to prevent the entrance of precipitation;</text> </paragraph> <paragraph num="(2)"> <text>Adequate floor area for safe access to all equipment;</text> </paragraph> <paragraph num="(3)"> <text>A minimum ceiling height of 7 feet 6 inches;</text> </paragraph> <paragraph num="(4)"> <text>A waterproof floor that drains to a floor drain;</text> </paragraph> <paragraph num="(5)"> <text>A lockable entrance door that allows complete and unencumbered access to the equipment room;</text> </paragraph> <paragraph num="(6)"> <text>A minimum of 20 footcandles of artificial illumination;</text> </paragraph> <paragraph num="(7)"> <text>Ventilation sized at 2 cubic feet per minute per square foot of floor area that is:</text> <paragraph num="(a)"> <text>Mechanical exhaust ventilation if chemicals are used or stored in the equipment room, or</text> </paragraph> <paragraph num="(b)"> <text>Natural or mechanical exhaust ventilation if chemicals are not used or stored in the equipment room;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Adequate make-up air to replace the air exhausted by the ventilation system;</text> </paragraph> <paragraph num="(9)"> <text>A hose bibb with an atmospheric vacuum breaker; and</text> </paragraph> <paragraph num="(10)"> <text>A water-resistant data sheet that is posted in a conspicuous place for each pool or spa and that includes the following information:</text> <paragraph num="(a)"> <text>Volume of water,</text> </paragraph> <paragraph num="(b)"> <text>Minimum turnover rate,</text> </paragraph> <paragraph num="(c)"> <text>Maximum filter capacity,</text> </paragraph> <paragraph num="(d)"> <text>Water surface area,</text> </paragraph> <paragraph num="(e)"> <text>Length of water perimeter,</text> </paragraph> <paragraph num="(f)"> <text>Maximum bather load, and</text> </paragraph> <paragraph num="(g)"> <text>Operating instructions for valves and equipment.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Pipe Material."> <text>An owner shall ensure that pipe material for a public pool or spa conforms to COMAR 09.20.01.</text> </regulation> <regulation prefix="Regulation" num=".25" heading="Circulation Systems."> <paragraph num="A."> <text>Gauges and Release Valves. An owner shall ensure that the circulation system for a recreational pool, semipublic pool, or public spa includes the following:</text> <paragraph num="(1)"> <text>A pressure gauge on the filter or on the influent side of the filter piping;</text> </paragraph> <paragraph num="(2)"> <text>A pressure gauge on the effluent side of the filter piping;</text> </paragraph> <paragraph num="(3)"> <text>A vacuum or compound gauge on the influent side of a pump;</text> </paragraph> <paragraph num="(4)"> <text>A flow meter that:</text> <paragraph num="(a)"> <text>Indicates the rate of flow through the circulation system;</text> </paragraph> <paragraph num="(b)"> <text>Has a permanent scale readable in gallons per minute;</text> </paragraph> <paragraph num="(c)"> <text>Is accurate to within 10 percent of the actual flow; and</text> </paragraph> <paragraph num="(d)"> <text>Reads in the range encompassing the minimum and maximum flow rate;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A thermometer on the return line to a pool or spa if the circulation system includes a heating system; and</text> </paragraph> <paragraph num="(6)"> <text>A manually operated air release valve on a pressure filter or a separation tank, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Turnover Rate. An owner shall ensure that:</text> <paragraph num="(1)"> <text>A recreational pool, semipublic pool, or public spa is constructed to produce the following minimum turnover rates, with continuous 24-hour flow:</text> <paragraph num="(a)"> <text>Pools for swimming and diving: Minimum turnover rate = volume of pool in gallons/480 minutes;</text> </paragraph> <paragraph num="(b)"> <text>Pools for water recreational attractions and therapy: Minimum turnover rate = volume of pool in gallons/360 minutes;</text> </paragraph> <paragraph num="(c)"> <text>Pools for wading have a minimum turnover rate equal to the greater of:</text> <paragraph num="(i)"> <text>Volume of pool in gallons/120 minutes; or</text> </paragraph> <paragraph num="(ii)"> <text>The minimum flow required for the skimmer system and main drain to operate according to the manufacturer's specifications; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Spas: Minimum turnover rate = volume of spa/30 minutes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The flow through a circulation system is maintained between the minimum turnover rate and the design capacity of the filter system and associated piping; and</text> </paragraph> <paragraph num="(3)"> <text>A limited public-use pool has a turnover rate in conformance with:</text> <paragraph num="(a)"> <text>American National Standard for Residential Inground Swimming Pools; or</text> </paragraph> <paragraph num="(b)"> <text>American National Standard for Aboveground/Onground Residential Swimming Pools.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Head Loss Calculations. An owner of a recreational pool, semipublic pool, or public spa shall ensure that head loss calculations include the following:</text> <paragraph num="(1)"> <text>Piping head loss, found by using:</text> <paragraph num="(a)"> <text>The Hazen-Williams formula which is: piping head loss per 100 feet of pipe = 0.2083 (100 / C) 1.852 (Q1.852/ D4.865)</text> </paragraph> <paragraph num="(b)"> <text>Standard engineering tables;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Equipment head loss, including filters, valves, heaters, and other circulation equipment, based on the manufacturers' specifications for the equipment at the design flow rate, and filter pressure differential with the filter in a clean and in a dirty condition;</text> </paragraph> <paragraph num="(3)"> <text>Elevation of pump suction and discharge in relation to the pool or spa water surface level; and</text> </paragraph> <paragraph num="(4)"> <text>Determination of the total dynamic head of the circulation system for use in pump selection.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Surface to Bottom Flow Ratio.</text> <paragraph num="(1)"> <text>An owner of a recreational pool, semipublic pool, or public spa shall ensure that:</text> <paragraph num="(a)"> <text>Piping for surface outlets is designed to accommodate 80 percent of the flow; and</text> </paragraph> <paragraph num="(b)"> <text>Piping for bottom outlets is designed to accommodate 20 percent of the flow.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An owner of a recreational pool or semipublic pool may have a gutter surface overflow system with a flow design of 50 percent from the surface outlets and 50 percent from the bottom outlets.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Filter Capacity. An owner of a recreational pool, semipublic pool, or public spa shall ensure that a filter:</text> <paragraph num="(1)"> <text>Operates within the filter design flow rate;</text> </paragraph> <paragraph num="(2)"> <text>Has a filtration capacity sufficient to operate in the range between the minimum turnover rate and the filter design flow rate when the circulation system is at the:</text> <paragraph num="(a)"> <text>Lowest level of calculated total dynamic head when the filter is in a clean condition; and</text> </paragraph> <paragraph num="(b)"> <text>Highest level of calculated total dynamic head when the filter pressure differential is at the maximum allowed in Regulation .43E of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Interconnections Between Pools. An owner of a recreational pool, semipublic pool, or public spa shall ensure that a pool is not interconnected with a:</text> <paragraph num="(1)"> <text>Spa or wading pool except during the filling of a spa or wading pool; and</text> </paragraph> <paragraph num="(2)"> <text>Spray pool.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For a public pool or spa with a flow rate that is at least 10 percent greater than the design capacity of the filter system or associated piping or at least 10 percent less than the minimum turnover rate as specified in §B of this regulation, an owner or operator shall:</text> <paragraph num="(1)"> <text>Record the information required in Regulation .46C of this chapter in 1-hour intervals; and</text> </paragraph> <paragraph num="(2)"> <text>Prior to restoring normal circulation, vacate the pool or spa of all bathers until:</text> <paragraph num="(a)"> <text>15 minutes after restarting the pump; and</text> </paragraph> <paragraph num="(b)"> <text>The water quality is verified as not exceeding the limits set for a major violation under Regulation .05(7-1) of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Circulation System Components."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an owner of a recreational pool, semipublic pool, or public spa shall ensure that circulation system components, including skimmers, pumps, filters, multiport valves, adjustable output rate chemical feeders, flow-through chemical feeders, chemical process equipment, chlorine generators, ion generators, and other pool and spa equipment comply with Circulation System Components and Related Materials for Pools, Spas/Hot Tubs.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall accept swimming pool, spa, or hot tub circulation system components as meeting the requirements set forth in §A of this regulation if these items are in the current published NSF listing of swimming pool, spa, or hot tub circulation system components or a listing from organizations accredited by the American National Standards Institute (ANSI) for the certification of circulation system components.</text> </paragraph> <paragraph num="C."> <text>Chemical Feeder and Process Equipment. An owner of a recreational pool, semipublic pool, or public spa shall ensure that the capacity of chemical feeder and process equipment is adequate to:</text> <paragraph num="(1)"> <text>Provide the minimum required disinfectant residual to the pool or spa water, as required in Regulation .44A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Establish breakpoint when the combined chlorine level is over 0.2 ppm.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Chlorine Gas Feeders. An owner of a recreational pool, semipublic pool, or public spa shall ensure that the:</text> <paragraph num="(1)"> <text>Equipment installation, and operation of a chlorine gas feeder are in compliance with the American National Standard for Public Swimming Pools, with the exception that the word “shall” is substituted for the word “should”, and the owner is required to comply with the specifications of Appendix E; and</text> </paragraph> <paragraph num="(2)"> <text>Recirculated water is treated downstream of the chlorine gas injection point to maintain the water's pH between 7.2 and 7.8.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Vacuum Systems.</text> <paragraph num="(1)"> <text>An owner shall ensure that a recreational pool, semipublic pool, or public spa has a vacuum system for cleaning the pool or spa floor.</text> </paragraph> <paragraph num="(2)"> <text>An owner of a recreational pool, semipublic pool, or public spa may use skimmer outlet pipes for vacuum purposes for circulation systems with four or fewer skimmers.</text> </paragraph> <paragraph num="(3)"> <text>For circulation systems with more than four skimmers or a gutter system, an owner of a recreational pool, semipublic pool, or public spa shall ensure that a vacuum system is provided that is separate from the skimmer or gutter system.</text> </paragraph> <paragraph num="(4)"> <text>If vacuum fittings are provided within a recreational pool, semipublic pool, or public spa, the owner shall ensure that the fittings are:</text> <paragraph num="(a)"> <text>Located at convenient locations approximately 1 foot below the water surface; and</text> </paragraph> <paragraph num="(b)"> <text>Provided with flush removable caps.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When the vacuum system is an integral part of the circulation system, an owner of a recreational pool, semipublic pool, or public spa shall ensure that the vacuum line connection is before the pump hair and lint strainer.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Carbon Dioxide Feeders. An owner of a recreational pool, semipublic pool, or public spa shall ensure that a carbon dioxide feeder system is:</text> <paragraph num="(1)"> <text>Installed and maintained in accordance with the manufacturer's specifications;</text> </paragraph> <paragraph num="(2)"> <text>Located in a ventilated area; and</text> </paragraph> <paragraph num="(3)"> <text>Secured to prevent damage to the gas cylinder if the cylinder is subject to tipping.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Ozone Systems. An owner of a recreational pool, semipublic pool, or public spa shall ensure that:</text> <paragraph num="(1)"> <text>An ultraviolet light ozone system is used and installed according to Circulation System Components and Related Materials for Pools, Spas/Hot Tubs;</text> </paragraph> <paragraph num="(2)"> <text>A corona discharge ozone system is used and installed according to Circulation System Components and Related Materials for Pools, Spas/Hot Tubs, and the following requirements:</text> <paragraph num="(a)"> <text>The system is designed to provide a minimum concentration of ozone generated to be 1.5 percent by weight;</text> </paragraph> <paragraph num="(b)"> <text>The ozone gas is diffused through a static mixer into a contact column with a sidestream flow of recirculated water equal to a minimum of 5 percent of the required turnover rate;</text> </paragraph> <paragraph num="(c)"> <text>The system is designed to provide a contact time of:</text> <paragraph num="(i)"> <text>2 minutes when used in conjunction with a chlorine disinfectant; or</text> </paragraph> <paragraph num="(ii)"> <text>1 minute when used in conjunction with a bromine disinfectant;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The system provides a minimum contact time value of 0.5 milligram/liter in the contact column when the contact time value equals the concentration of dissolved ozone in milligrams/liter times the contact time in minutes;</text> </paragraph> <paragraph num="(e)"> <text>The air feed, which is natural or oxygen enriched air, is filtered to remove particulates and dehumidified to a minimum dew point of minus 60°C before the ozone generating chamber;</text> </paragraph> <paragraph num="(f)"> <text>An ozone gas feed line is ozone resistant;</text> </paragraph> <paragraph num="(g)"> <text>Valves are provided to control flow through the system;</text> </paragraph> <paragraph num="(h)"> <text>Offgas venting from the contact column is:</text> <paragraph num="(i)"> <text>Equipped with an ozone destruct system that removes all ozone before release to the atmosphere; or</text> </paragraph> <paragraph num="(ii)"> <text>Returned to the main recirculation line when used in conjunction with a bromine disinfectant;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>When necessary, a foam suppression system is provided before offgas venting;</text> </paragraph> <paragraph num="(j)"> <text>The oxidation reduction potential of the sidestream after contact and before dissolved ozone removal is a minimum of 650 millivolts;</text> </paragraph> <paragraph num="(k)"> <text>The dissolved ozone is removed from the sidestream using granulated activated carbon before remixing with the recirculated water when used in conjunction with a chlorine disinfectant;</text> </paragraph> <paragraph num="(l)"> <text>The ozone generating system shuts off if the water recirculating system shuts off or if the vacuum is lost on the ozone gas output line;</text> </paragraph> <paragraph num="(m)"> <text>The ozone gas output is under negative pressure or a vacuum;</text> </paragraph> <paragraph num="(n)"> <text>The ozone generation area is ventilated at 2 cfm per square foot of floor area to prevent the build up of excess ozone; and</text> </paragraph> <paragraph num="(o)"> <text>The recirculated water is treated to maintain the pH between 7.2 and 7.8.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>An owner of a recreational pool, semipublic pool, or public spa may connect an equalization line for a skimmer to the main drain line in a wading pool, or other pool that does not have sufficient water depth, for the installation of the equalizer line through the pool wall below the skimmer throat.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Diving Area and Equipment."> <text>An owner of a public pool shall ensure that:</text> <paragraph num="A."> <text>A pool used for accredited competitive aquatic events as defined in §3 of the American National Standard for Public Swimming Pools is in compliance with §6.4.1 of American National Standard for Public Swimming Pools;</text> </paragraph> <paragraph num="B."> <text>The dimensions of a pool diving area are in conformance with the following minimum dimensions and explanatory diagram:</text> <paragraph num="(1)"> <text>Minimum dimensions:</text> </paragraph> <paragraph num="(2)"> <text>Explanatory diagram</text> </paragraph> <paragraph num="(3)"> <text>The transitional radius from wall to floor are in conformance with Article IV of the American National Standard for Public Swimming Pools.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Diving equipment is installed in compliance with §§7.2.5—7.2.5.6 of the American National Standards for Public Swimming Pools;</text> </paragraph> <paragraph num="D."> <text>Unobstructed clearance is provided for a diving board in conformance with the following minimum dimensions:</text> <paragraph num="(1)"> <text>A minimum height of:</text> <paragraph num="(a)"> <text>13 feet measured upward from the plummet of a diving board; or</text> </paragraph> <paragraph num="(b)"> <text>Greater than 13 feet if specified by the manufacturer of the diving board;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A clearance as required in §D(1) of this regulation extending:</text> <paragraph num="(a)"> <text>16 feet forward of the plummet;</text> </paragraph> <paragraph num="(b)"> <text>8 feet behind the plummet; and</text> </paragraph> <paragraph num="(c)"> <text>8 feet to both sides of the plummet;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A minimum distance of 10 feet between the plummets of adjacent diving boards; and</text> </paragraph> <paragraph num="(4)"> <text>A minimum distance between a diving board plummet and a side wall of:</text> <paragraph num="(a)"> <text>10 feet for a diving board 20 inches or less above the water line; and</text> </paragraph> <paragraph num="(b)"> <text>12 feet for a diving board greater than 20 inches above the water line;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Diving boards in excess of 10 feet above the water line and diving platforms are in compliance with §7.2.4 of the American National Standard for Public Swimming Pools; and</text> </paragraph> <paragraph num="F."> <text>A starting block:</text> <paragraph num="(1)"> <text>Is located on the pool deck so that a swimmer dives into a minimum of 5 feet water depth; or</text> </paragraph> <paragraph num="(2)"> <text>At a pool constructed before February 10, 1997, is located so that a swimmer dives into a minimum of:</text> <paragraph num="(a)"> <text>5 feet water depth when the starting block is used without supervision; or</text> </paragraph> <paragraph num="(b)"> <text>4 feet water depth when the starting block is:</text> <paragraph num="(i)"> <text>Used in a controlled environment such as a swimming competition under the supervision of an instructor; and</text> </paragraph> <paragraph num="(ii)"> <text>Restricted from unsupervised use or is removed when not under supervised use.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Suction Entrapment Prevention."> <text>To prevent a suction entrapment hazard, an owner shall ensure that:</text> <paragraph num="A."> <text>A vacuum fitting is capped when not in use;</text> </paragraph> <paragraph num="B."> <text>A vacuum line valve is in the closed position when not in use;</text> </paragraph> <paragraph num="C."> <text>Except as provided in §§F and G of this regulation, the main drain for a public pool or spa complies with 15 U.S.C. §8003 and is:</text> <paragraph num="(1)"> <text>Connected to a minimum of two main drain outlets that are:</text> <paragraph num="(a)"> <text>Not isolated by a valve or other means;</text> </paragraph> <paragraph num="(b)"> <text>Spaced at least 3 feet from edge to edge; and</text> </paragraph> <paragraph num="(c)"> <text>Hydraulically balanced; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An unblockable drain.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A drain is covered with a securely attached drain cover in compliance with the:</text> <paragraph num="(1)"> <text>American National Standard for Public Swimming Pools; and</text> </paragraph> <paragraph num="(2)"> <text>15 U.S.C. §8003.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A skimmer is:</text> <paragraph num="(1)"> <text>Connected to an equalization line, main drain line, vent, or another skimmer that cannot be isolated by a valve or other means, or</text> </paragraph> <paragraph num="(2)"> <text>Provided with a vented lid;</text> </paragraph> </paragraph> <paragraph num="F."> <text>A pool or spa constructed before February 10, 1997 is provided by June 1, 2002, with:</text> <paragraph num="(1)"> <text>At least two hydraulically balanced drain outlets spaced a minimum of 3 feet from edge to edge that cannot be isolated to create a single outlet for each circulation pump, as illustrated in Regulation .28-1A of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A channel drain system that is at least 3 feet from edge to edge, as illustrated in Regulation .28-1B of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>An approved safety vacuum release system.</text> </paragraph> </paragraph> <paragraph num="G."> <text>As an interim measure, until a pool or spa constructed before February 10, 1997 is in compliance with §F of this regulation:</text> <paragraph num="(1)"> <text>A pool or spa has a minimum of two outlets that cannot be isolated to create a single outlet per pump; and</text> </paragraph> <paragraph num="(2)"> <text>These outlets are provided by connecting the main drain line to a skimmer line so that the lines cannot be isolated to create a single outlet, as illustrated in Regulation .28-1C of this chapter, assuring that:</text> <paragraph num="(a)"> <text>The skimmer line does not become blocked within the skimmer housing at any time;</text> </paragraph> <paragraph num="(b)"> <text>Associated valves are locked in an open position to prevent the drain or the skimmer from becoming a single source of suction; and</text> </paragraph> <paragraph num="(c)"> <text>Associated valves are permanently tagged with a warning to maintain the valves in the open position at all times when the pool or spa is in use;</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>A pool or spa is in compliance with the following:</text> <paragraph num="(1)"> <text>A suction outlet is provided with a cover that complies with the American National Standard for Public Swimming Pools;</text> </paragraph> <paragraph num="(2)"> <text>A suction fitting complies with 15 U.S.C. §8003;</text> </paragraph> <paragraph num="(3)"> <text>Suction outlet covers are:</text> <paragraph num="(a)"> <text>Installed, not broken, not cracked, and securely in place; and</text> </paragraph> <paragraph num="(b)"> <text>Installed according to the manufacturer’s instructions;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Suction outlet covers are secured according to manufacturers' directions and in such a way that the covers cannot be removed without the use of tools;</text> </paragraph> <paragraph num="(5)"> <text>A pool or spa that does not have suction outlets in compliance with this regulation has all pumps immediately shut off until the pool or spa has been brought into compliance with this regulation;</text> </paragraph> <paragraph num="(6)"> <text>The maximum velocity in the design of the drain piping does not exceed 6 feet per second when 100 percent of the circulation system design flow is drawn through the drain piping of any single drain;</text> </paragraph> <paragraph num="(7)"> <text>A pool or spa facility has a comprehensive written maintenance program that addresses the following:</text> <paragraph num="(a)"> <text>If a suction outlet cover is cracked or broken, the pump shall be immediately shut off and the cover shall be replaced;</text> </paragraph> <paragraph num="(b)"> <text>Covers shall be anchored in accordance with the manufacturer's specifications and supplied parts, and only manufacturer specified, noncorrosive fasteners may be used;</text> </paragraph> <paragraph num="(c)"> <text>Lines and equipment shall be labeled or color coded for ready identification; and</text> </paragraph> <paragraph num="(d)"> <text>The on/off switch for circulation pumps shall be clearly identified and labeled; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Check valves in the suction line to pumps are removed to allow backflow of water or air to release the suction when the pump is shut off or when an influent blockage detection device is activated; and</text> </paragraph> </paragraph> <paragraph num="I."> <text>A pool and spa operator completes the Pool and Spa Entrapment Hazards Checklist provided by the Secretary, or an equivalent form, on a daily basis before the pool or spa is open for that day's use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28-1" heading="Drain System Figures."> <paragraph num="A."> <text>Dual Drain System.</text> </paragraph> <paragraph num="B."> <text>Channel Drain System.</text> </paragraph> <paragraph num="C."> <text>Main Drain and Skimmer Line System.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Chemical Storage Area."> <text>An owner shall ensure that a recreational pool, semipublic pool, or public spa has a chemical storage area that:</text> <paragraph num="A."> <text>Is protected against the weather, excess heat, and moisture; and</text> </paragraph> <paragraph num="B."> <text>Has:</text> <paragraph num="(1)"> <text>A lockable door which can be opened from the inside;</text> </paragraph> <paragraph num="(2)"> <text>Ventilation that is sized at 2 cfm per square foot of floor area and that exhausts to the open air;</text> </paragraph> <paragraph num="(3)"> <text>A minimum of 20 footcandles of illumination; and</text> </paragraph> <paragraph num="(4)"> <text>Storage for chemicals in accordance with the material safety data sheet for a particular chemical.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Hydrostatic Relief Valves."> <text>An owner shall ensure that an in-ground recreational pool, semipublic pool, or public spa has hydrostatic relief valves as needed to relieve the hydrostatic pressure from ground water when the pool or spa is empty.</text> </regulation> <regulation prefix="Regulation" num=".31" heading="Filter Backwash Water and Deck Drainage Disposal."> <paragraph num="A."> <text>An owner shall ensure that:</text> <paragraph num="(1)"> <text>The disposal of filter backwash water and pool or spa wastewater conforms with:</text> <paragraph num="(a)"> <text>COMAR 09.20.01;</text> </paragraph> <paragraph num="(b)"> <text>Local sanitary code requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Discharge requirements of COMAR 26.08.01—26.08.04; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Deck drainage disposal conforms with:</text> <paragraph num="(a)"> <text>COMAR 09.20.01; and</text> </paragraph> <paragraph num="(b)"> <text>Local plumbing code requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An owner may not return filter backwash water or other wastewater to a pool or spa, except for filter backwash water that has been filtered to remove particulates and treated to eliminate coliform bacteria and waterborne pathogens.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Illumination of Water, Deck, and Walkway."> <text>An owner shall ensure that an indoor recreational pool, semipublic pool, or public spa, or one used during nighttime, is provided with:</text> <paragraph num="A."> <text>Even illumination of the water, deck, and walkways;</text> </paragraph> <paragraph num="B."> <text>Illumination of the water and deck that is:</text> <paragraph num="(1)"> <text>A combination of underwater lighting and deck lighting so that the:</text> <paragraph num="(a)"> <text>Underwater lighting yields at least 0.5 watt per square foot of water surface area; and</text> </paragraph> <paragraph num="(b)"> <text>Deck lighting yields at least 0.6 watt per square foot of required deck area or at least 15 footcandles; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Overhead lighting yielding at least 2 watts per square foot of required deck area or at least 20 footcandles of light that is directed onto the deck and the water surface so that the entire pool or spa bottom is clearly visible;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Lighting that minimizes reflection from the water surface so that the visibility of the pool or spa bottom is not obscured; and</text> </paragraph> <paragraph num="D."> <text>Walkway lighting yielding at least 15 footcandles of light.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Ventilation of an Indoor Recreational Pool, Semipublic Pool, or Public Spa."> <text>An owner shall ensure that an indoor recreational pool, semipublic pool, or public spa has:</text> <paragraph num="A."> <text>A ventilating system capable of:</text> <paragraph num="(1)"> <text>Exhausting 1 1/2 cfm of air per square foot of enclosed area; or</text> </paragraph> <paragraph num="(2)"> <text>Dehumidifying the recirculated air from the enclosed area; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Make-up air equal to the volume of exhausted air or as required in the ventilation system specifications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Plumbing."> <paragraph num="A."> <text>Water Supply System. An owner shall ensure that a water supply system at a public pool or spa is in conformance with:</text> <paragraph num="(1)"> <text>COMAR 26.04.01, 26.04.03, and 26.04.04;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 09.20.01; and</text> </paragraph> <paragraph num="(3)"> <text>Local plumbing code requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Sewage Disposal System. An owner shall ensure that a sewage disposal system at a public pool or spa is in conformance with:</text> <paragraph num="(1)"> <text>COMAR 26.04.02 and 26.04.03;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 09.20.01; and</text> </paragraph> <paragraph num="(3)"> <text>Local plumbing code requirements.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Drinking Fountains. An owner shall ensure that a recreational pool, semipublic pool, or public spa enclosure has at least one drinking fountain for every 5,000 square feet of water surface area.</text> </paragraph> <paragraph num="D."> <text>Hose Bibbs. An owner of a recreational pool, semipublic pool, or public spa shall ensure that the following locations have an accessible hose bibb equipped with an atmospheric vacuum breaker:</text> <paragraph num="(1)"> <text>On the deck at 150 feet intervals;</text> </paragraph> <paragraph num="(2)"> <text>In an equipment room; and</text> </paragraph> <paragraph num="(3)"> <text>In both a men's and a women's bathhouse.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Fill Spouts. If a fill spout is installed at a public pool or spa, the owner shall ensure that the fill spout is:</text> <paragraph num="(1)"> <text>Installed within 10 inches of a ladder or handrail or in front of a lifeguard stand whose supports are immediately adjacent to the pool or spa rim, so that the fill spout does not present a tripping hazard or a puncture hazard;</text> </paragraph> <paragraph num="(2)"> <text>Not installed over a seat bench;</text> </paragraph> <paragraph num="(3)"> <text>Braced or constructed so the fill spout does not flex downward; and</text> </paragraph> <paragraph num="(4)"> <text>Provided with a flexible cover on the tip of the fill spout if the spout presents a potential for injury to an individual using a pool or spa.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Backflow Prevention. An owner of a public pool or spa shall ensure that:</text> <paragraph num="(1)"> <text>A pool or spa facility has backflow protection for:</text> <paragraph num="(a)"> <text>A potable water supply, in conformance with COMAR 09.20.01; and</text> </paragraph> <paragraph num="(b)"> <text>Wastewater, in conformance with COMAR 09.20.01; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An air gap that is two times the diameter of the fill spout separates the fill spout from the flood rim level of the pool or spa.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Source of Water. An owner of a public pool or spa shall ensure that:</text> <paragraph num="(1)"> <text>When a public pool or spa is filled with water from a nonpotable source, such as a water tank holding nonpotable water or surface water, the:</text> <paragraph num="(a)"> <text>Water is filtered, treated, and disinfected after addition to the pool or spa to meet the requirements of Regulation .44 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Pool or spa is not used until a bacteriological sample taken by the Secretary indicates that there are no coliform organisms in the water; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Public pool or spa make-up water:</text> <paragraph num="(a)"> <text>Is from a potable source; and</text> </paragraph> <paragraph num="(b)"> <text>Having an iron level over 0.3 ppm is treated to lower the iron level to 0.3 ppm or less before the make-up water is added to a pool or a spa.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Toilet, Hand Sink, and Shower Facilities."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an owner shall ensure that a recreational pool, semipublic pool, or public spa has:</text> <paragraph num="(1)"> <text>A bathhouse, toilets, hand sinks, and showers within 100 feet of an entrance gate to the pool or spa in accordance with the American National Standard for Public Swimming Pools, Articles 19.1—19.6.13;</text> </paragraph> <paragraph num="(2)"> <text>At least a minimum number of toilets, hand sinks, and showers based on:</text> <paragraph num="(a)"> <text>The maximum user load of the pool or spa set forth in Regulation .19 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Fixture ratios set forth in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>State and local building codes;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>50 percent of the required fixtures designated for use by each sex, unless the pool or spa is for one sex only; and</text> </paragraph> <paragraph num="(4)"> <text>At least 50 percent of the required showers located within a bathhouse.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner is not required to provide toilet, hand sink, and shower facilities at a recreational pool, semipublic pool, or public spa when bathers have access to equivalent facilities in:</text> <paragraph num="(1)"> <text>Living quarters not more than 500 feet from a pool or a spa entrance; or</text> </paragraph> <paragraph num="(2)"> <text>A building or buildings not more than 500 feet from a pool or a spa entrance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An owner shall ensure that equivalent facilities used by recreational pool, semipublic pool, or public spa bathers and patrons of a recreational center, health club, marina, or other facility are in compliance with:</text> <paragraph num="(1)"> <text>Section A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>State or local plumbing codes regarding fixtures and dressing area for the patrons sharing the equivalent facilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Antiscald Protection for Showers."> <text>An owner of a recreational pool, semipublic pool, or public spa shall ensure that each shower has an approved pressure-balanced, antiscald device that limits the delivered water temperature to below 115°F.</text> </regulation> <regulation prefix="Regulation" num=".37" heading="Accommodations for Disabled Individuals."> <text>An owner shall ensure that a public pool or spa is in compliance with all applicable federal, State, and local codes governing facilities for disabled individuals, including COMAR 05.02.02.</text> </regulation> <regulation prefix="Regulation" num=".38" heading="Equipment Installation and Operating Instructions."> <text>An owner of a public pool or spa shall ensure that:</text> <paragraph num="A."> <text>Pool and spa equipment is installed according to manufacturers' instructions and this chapter;</text> </paragraph> <paragraph num="B."> <text>Valves, controls, gauges, filters, pumps, feeders, and other operating equipment are easily accessible;</text> </paragraph> <paragraph num="C."> <text>Valves, controls, and piping are permanently numbered, labeled, or color-coded to identify their purpose or function; and</text> </paragraph> <paragraph num="D."> <text>Operating instructions for the circulation and water treatment systems:</text> <paragraph num="(1)"> <text>Refer to the number, label, or color code of the valves, controls, and piping, and</text> </paragraph> <paragraph num="(2)"> <text>Are posted in the equipment room in a water-resistant cover.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Maintenance."> <text>An owner of a public pool or spa shall ensure that:</text> <paragraph num="A."> <text>An inspection of the pool or spa and related facilities is made at least once a week by the operator for the purpose of maintaining the pool or spa in compliance with this chapter;</text> </paragraph> <paragraph num="B."> <text>The pool or spa and its related facilities are maintained in a safe, clean, and orderly condition;</text> </paragraph> <paragraph num="C."> <text>A broken, damaged, or malfunctioning fixture is promptly repaired or replaced; and</text> </paragraph> <paragraph num="D."> <text>The pool or spa is left in a safe condition when closed for the season.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Public Pool and Spa Safety."> <paragraph num="A."> <text>First Aid and Lifesaving Equipment. An owner shall ensure that:</text> <paragraph num="(1)"> <text>A recreational pool is provided with:</text> <paragraph num="(a)"> <text>A first aid kit as recommended by the American Red Cross;</text> </paragraph> <paragraph num="(b)"> <text>A face mask for CPR;</text> </paragraph> <paragraph num="(c)"> <text>Disposable medical grade examination gloves;</text> </paragraph> <paragraph num="(d)"> <text>A bloodborne pathogen control kit;</text> </paragraph> <paragraph num="(e)"> <text>A backboard designed for medical emergency use that is equipped with straps and head immobilizer;</text> </paragraph> <paragraph num="(f)"> <text>A light, strong rescue pole not less than 10 feet long; and</text> </paragraph> <paragraph num="(g)"> <text>A rescue tube designed for lifesaving for each required lifeguard;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as set forth in §A(3) of this regulation, a public spa is provided with the safety equipment required in §A(1)(a)—(e) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>A semipublic spa is provided with the safety equipment required in §A(1)(a)—(d) of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>A semipublic pool is provided with a:</text> <paragraph num="(a)"> <text>Light, strong rescue pole not less than 10 feet long; and</text> </paragraph> <paragraph num="(b)"> <text>Ring buoy or similar approved floatation device with an attached throwing rope measuring 50 feet in length or 1-1/2 times the width of the pool, whichever is longer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Telephone. An owner shall ensure that, in case of an emergency, a telephone is available within the pool or spa enclosure to individuals using a public pool or spa that:</text> <paragraph num="(1)"> <text>Can directly reach a 911 emergency service without the use of a coin and without connection to an internal switchboard;</text> </paragraph> <paragraph num="(2)"> <text>Is posted with:</text> <paragraph num="(a)"> <text>The names and phone numbers of the nearest available police, fire, and ambulance or rescue unit; or</text> </paragraph> <paragraph num="(b)"> <text>911 or with any numbers necessary to reach a 911 emergency service center directly; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is posted with the name and location of the pool or spa facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Lifeguard Chair.</text> <paragraph num="(1)"> <text>An owner shall ensure that a recreational pool is equipped with lifeguard chairs in compliance with the American National Standard for Public Swimming Pools.</text> </paragraph> <paragraph num="(2)"> <text>An owner may use a deck-level lifeguard chair in a designated area on the deck adjacent to shallow water instead of an elevated lifeguard chair.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Lifeguards.</text> <paragraph num="(1)"> <text>An owner of a public pool shall comply with:</text> <paragraph num="(a)"> <text>Local codes requiring lifeguards if the requirements of the local codes are stricter than the requirements set forth in §D(2)—(5) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>§D(2)—(5) of this regulation if no local codes exist, or if the local codes requiring lifeguards are not as strict as the requirements of §D(2)—(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as set forth in §D(1) and (3) of this regulation, an owner of a recreational pool shall have at least one lifeguard on duty on the deck observing the pool while an individual is in the pool, and shall have at the pool:</text> <paragraph num="(a)"> <text>Lifeguards who are appropriately trained and certified for the type of facility and activity in the pool;</text> </paragraph> <paragraph num="(b)"> <text>A sufficient number of lifeguards so that a lifeguard is on duty for each group of 50 individuals, or fraction thereof, in the pool; and</text> </paragraph> <paragraph num="(c)"> <text>In addition to the number of lifeguards required in §D(2)(b) of this regulation, additional lifeguards on duty if:</text> <paragraph num="(i)"> <text>The shape, dimensions, layout, use, activities, or features of the pool create potential safety hazards;</text> </paragraph> <paragraph num="(ii)"> <text>The vision of the required lifeguard or lifeguards is obstructed;</text> </paragraph> <paragraph num="(iii)"> <text>The capabilities of the individuals using the pool are substandard; or</text> </paragraph> <paragraph num="(iv)"> <text>Another condition exists that compromises the ability of a lifeguard to monitor the pool.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An owner may use a lifeguard on the deck of a swimming pool to monitor an adjacent wading pool, but if a wading pool is the only pool at a facility or if the wading pool cannot be observed from the deck of the swimming pool, the owner shall ensure that lifeguards are provided at the wading pool in accordance with §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>In addition to meeting the other requirements of this chapter, an owner or operator of a facility specified in the following paragraphs shall ensure that a:</text> <paragraph num="(a)"> <text>Limited public-use pool has water safety supervision for pool activities in compliance with Regulation .15 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Child care center has water safety supervision for pool activities at a child care center in compliance with COMAR 07.04.02.41; and</text> </paragraph> <paragraph num="(c)"> <text>Youth camp has water safety supervision for pool activities at a youth camp in compliance with COMAR 10.16.06.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The owner may only use or employ a lifeguard who holds a valid lifeguard certification from:</text> <paragraph num="(a)"> <text>The American Red Cross;</text> </paragraph> <paragraph num="(b)"> <text>The Boy Scouts of America, not including a lifesaving merit badge;</text> </paragraph> <paragraph num="(c)"> <text>The Young Men's Christian Association;</text> </paragraph> <paragraph num="(d)"> <text>Ellis and Associates' National Pool and Waterpark Lifeguard Training; or</text> </paragraph> <paragraph num="(e)"> <text>An organization that has a lifeguard training program equivalent to the American Red Cross lifeguard training.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except as set forth in §D(1) and (3) of this regulation, an owner of a semipublic pool that has a water surface area greater than 2,500 square feet or that is part of a multiple pool facility within one enclosure that has a combined water surface area greater than 2,500 square feet shall ensure that at least one lifeguard is on duty on the deck observing a pool in the ratio of one guard per 50 individuals in the water:</text> <paragraph num="(a)"> <text>During the peak seasonal use of the pool from Memorial Day to Labor Day; and</text> </paragraph> <paragraph num="(b)"> <text>During the use of an indoor, heated pool throughout the entire year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>CPR and First-Aid Personnel. Except at a semipublic spa, an owner of a recreational pool, public spa, and a limited public use pool shall ensure that:</text> <paragraph num="(1)"> <text>When the pool or spa is open for use, an individual is present and on-site, holding a valid certification for:</text> <paragraph num="(a)"> <text>Infant/child/adult or professional rescuer cardiopulmonary resuscitation (CPR); and</text> </paragraph> <paragraph num="(b)"> <text>First aid; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The CPR and first aid certifications of the individual required in §E(1) of this regulation are from:</text> <paragraph num="(a)"> <text>A national organization offering certification in CPR or first aid, such as the:</text> <paragraph num="(i)"> <text>American Red Cross;</text> </paragraph> <paragraph num="(ii)"> <text>American Heart Association; or</text> </paragraph> <paragraph num="(iii)"> <text>National Safety Council;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Emergency Medical Services; or</text> </paragraph> <paragraph num="(c)"> <text>An organization that has a certification program in CPR or first aid that is approved by one of the organizations listed in §E(2) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Safety Signs. An owner of a public pool or spa shall ensure that:</text> <paragraph num="(1)"> <text>The size, color, design, application, symbol, and visual layout of a safety sign is in compliance with the ANSI Z-535 series of standards for Safety Signs and Colors as referenced in American National Standard for Public Spas;</text> </paragraph> <paragraph num="(2)"> <text>A spa safety sign is posted in a permanent location adjacent to a spa in compliance with the American National Standard for Public Spas;</text> </paragraph> <paragraph num="(3)"> <text>The spa safety sign includes the user load of the spa;</text> </paragraph> <paragraph num="(4)"> <text>A chemical warning sign is posted at the entrance door to a chemical storage area and includes the text “Caution! Chemical Storage Area”;</text> </paragraph> <paragraph num="(5)"> <text>A chemical vat, feeder, pump, and line is labeled to identify the chemical in use;</text> </paragraph> <paragraph num="(6)"> <text>A chlorine gas warning sign reading “Danger—Chlorine Gas” is posted at the entrance to a chlorine gas feed room and storage area;</text> </paragraph> <paragraph num="(7)"> <text>Other warning, health advisory, and safety signs are posted if necessary to protect the public health and safety, for example, “Danger! No Diving In Shallow Water”;</text> </paragraph> <paragraph num="(8)"> <text>A semipublic pool or public spa that does not have a lifeguard on duty has a conspicuous sign posted adjacent to entrances to the pool or spa reading “WARNING; NO LIFEGUARD ON DUTY. YOUR OWN RISK.</U> WITHOUT ADULT SUPERVISION.”; and</text> </paragraph> <paragraph num="(9)"> <text>House rules are posted at the entrance to a pool or spa.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".41" heading="Pool and Spa Operator Certification."> <paragraph num="A."> <text>A person may not act as or perform the duties of a public pool or spa operator without a pool and spa operator certification card issued by the Secretary as required in §§B and G of this regulation.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall issue a 3-year public pool and spa operator certification card only to an individual 16 years old or older who has:</text> <paragraph num="(1)"> <text>Completed a 14-hour approved public pool and spa operator's course or a course offered by the Secretary with a minimum grade of 70 percent on an approved written examination given following the completion of that course; or</text> </paragraph> <paragraph num="(2)"> <text>Presented proof of previous certification and has:</text> <paragraph num="(a)"> <text>Completed an approved 4-hour refresher course; or</text> </paragraph> <paragraph num="(b)"> <text>Passed a challenge exam offered by the Secretary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may summarily suspend a pool and spa operator's certification if the operator does not comply with Regulation .43 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Hearing for Summary Suspension. In the case of the summary suspension of certification pursuant to §C of this regulation, the Secretary shall provide the certification card holder with written notice of the suspension and an opportunity for a hearing pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>To preserve the right to a hearing, the certification card holder shall contact the Secretary within 30 days of the receipt of the notice of the suspension.</text> </paragraph> <paragraph num="F."> <text>The Secretary shall recognize a pool and spa operator certification as valid throughout the State.</text> </paragraph> <paragraph num="G."> <text>The Secretary shall issue a 3-year limited public-use pool operator certification card to an individual 16 years old or older who has completed:</text> <paragraph num="(1)"> <text>An approved 4-hour limited public-use pool operator's course and passed an approved written examination with a minimum grade of 75 percent following completion of the course; or</text> </paragraph> <paragraph num="(2)"> <text>The requirements of §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An individual who possesses a public pool and spa operator certification card may perform the duties of a public pool and spa operator at a limited public-use, recreational, and semipublic pool and public spa. An individual who possesses a limited public-use pool operator certification card may perform the duties of a limited public-use pool operator only at a limited public-use pool.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".42" heading="Approval of Operator's Course."> <text>The Secretary shall approve a pool and a spa operator's course based on the following criteria:</text> <paragraph num="A."> <text>An approved course shall cover general aspects of public pool and spa operation including:</text> <paragraph num="(1)"> <text>Applicable regulations;</text> </paragraph> <paragraph num="(2)"> <text>Disease prevention;</text> </paragraph> <paragraph num="(3)"> <text>Disinfection;</text> </paragraph> <paragraph num="(4)"> <text>Filtration;</text> </paragraph> <paragraph num="(5)"> <text>Circulation system components;</text> </paragraph> <paragraph num="(6)"> <text>General pool and spa equipment;</text> </paragraph> <paragraph num="(7)"> <text>Operation and maintenance of equipment;</text> </paragraph> <paragraph num="(8)"> <text>Water chemistry;</text> </paragraph> <paragraph num="(9)"> <text>Water testing;</text> </paragraph> <paragraph num="(10)"> <text>Record keeping;</text> </paragraph> <paragraph num="(11)"> <text>General pool and spa chemicals;</text> </paragraph> <paragraph num="(12)"> <text>Chemical handling;</text> </paragraph> <paragraph num="(13)"> <text>Waste water disposal;</text> </paragraph> <paragraph num="(14)"> <text>Safety;</text> </paragraph> <paragraph num="(15)"> <text>Sanitation; and</text> </paragraph> <paragraph num="(16)"> <text>Other pertinent topics as specified by the Secretary; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>An approved course shall be taught by an individual who has demonstrated to the Secretary:</text> <paragraph num="(1)"> <text>Expertise in the operational aspects listed in §A of this regulation, as evidenced by combined work experience, training, and formal education; and</text> </paragraph> <paragraph num="(2)"> <text>Successful completion of an approved public pool and spa operator's course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".43" heading="Pool and Spa Operation."> <text>An owner shall ensure that a certified pool and spa operator:</text> <paragraph num="A."> <text>Is on-site at all times when a recreational pool is open;</text> </paragraph> <paragraph num="B."> <text>Is available at a semipublic pool, public spa, and at a limited public-use pool for performance of all requirements of this chapter and is able to respond to operational problems within:</text> <paragraph num="(1)"> <text>30 minutes when not available on-site; or</text> </paragraph> <paragraph num="(2)"> <text>If a contractual certified pool and spa operator, 2 hours when not available on-site;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Measures and records, or supervises and verifies the measurement and recording of, all information required in Regulation .46 of this chapter;</text> </paragraph> <paragraph num="D."> <text>Performs all duties related to the operation of a pool or spa as required in this chapter;</text> </paragraph> <paragraph num="E."> <text>Cleans the filtration system when the filter pressure differential reaches a level specified by the equipment's manufacturer or as specified below:</text> <paragraph num="(1)"> <text>High rate sand filters at 15 psi;</text> </paragraph> <paragraph num="(2)"> <text>Rapid rate sand filters at 8 psi;</text> </paragraph> <paragraph num="(3)"> <text>Cartridge filters at 10 psi;</text> </paragraph> <paragraph num="(4)"> <text>Pressure diatomaceous earth filters at 10 psi; and</text> </paragraph> <paragraph num="(5)"> <text>Vacuum diatomaceous earth filters at 15 inches of mercury;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Maintains disinfection residuals according to Regulation .44 of this chapter;</text> </paragraph> <paragraph num="G."> <text>Maintains water chemistry according to Regulation .45 of this chapter; and</text> </paragraph> <paragraph num="H."> <text>Adds a nonstabilized oxidizer into the pool or spa water equivalent to an amount of free chlorine equal to at least 10 times the measured combined chlorine residual plus sufficient free chlorine to oxidize the ammonia and nitrogenous compounds in the water, on a recommended schedule of once per week for a pool and once per day for a wading pool and for a spa.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".44" heading="Disinfection of a Pool and Spa."> <paragraph num="A."> <text>An owner or operator of a public pool or spa shall ensure that a disinfectant or combination of disinfectants is added to the water automatically through an approved chemical feeder to maintain continuously a residual level as specified below:</text> <paragraph num="(1)"> <text>Free chlorine shall be between:</text> <paragraph num="(a)"> <text>1.5 ppm and 10.0 ppm in pools for swimming and diving and water recreational attractions;</text> </paragraph> <paragraph num="(b)"> <text>3.0 ppm and 10.0 ppm in pools for wading or therapy; and</text> </paragraph> <paragraph num="(c)"> <text>4.0 ppm and 10.0 ppm in spas;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The maximum amount of combined chlorine shall be 0.2 ppm for all pools and spas;</text> </paragraph> <paragraph num="(3)"> <text>Total bromine shall be between:</text> <paragraph num="(a)"> <text>3.0 ppm and 8.0 ppm in pools for swimming and diving and water recreational attractions; and</text> </paragraph> <paragraph num="(b)"> <text>4.0 ppm and 8.0 ppm in spas and in pools for wading or therapy;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For pools and spas using copper and silver ions as a secondary disinfectant in conjunction with chlorine or bromine as a primary disinfectant:</text> <paragraph num="(a)"> <text>Copper ions shall be between 0.2 ppm and 1.0 ppm;</text> </paragraph> <paragraph num="(b)"> <text>Silver ions may not exceed 0.05 ppm;</text> </paragraph> <paragraph num="(c)"> <text>Free chlorine in combination with copper and silver ions shall be between:</text> <paragraph num="(i)"> <text>0.5 ppm and 10 ppm in pools for swimming and diving and water recreational attractions; and</text> </paragraph> <paragraph num="(ii)"> <text>1.5 ppm and 10.0 ppm in spas and in a pool for wading or therapy; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Total bromine in combination with copper and silver ions shall be between:</text> <paragraph num="(i)"> <text>1.0 ppm and 8.0 ppm in pools for swimming and diving and water recreational attractions; and</text> </paragraph> <paragraph num="(ii)"> <text>3.0 ppm and 8.0 ppm in spas and pools for wading or therapy;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>For pools and spas using an ozone generator, the maximum amount of ozone measured 2 inches above the water surface shall be 0.1 ppm;</text> </paragraph> <paragraph num="(6)"> <text>For pools using PHMB, the minimum level of PHMB shall be 30 ppm; and</text> </paragraph> <paragraph num="(7)"> <text>For pools and spas using an ultraviolet light/hydrogen peroxide system, the minimum level of hydrogen peroxide shall be 20 ppm.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner or operator shall ensure that for public pools and spas using cyanuric acid or a similar chlorine stabilizer, the cyanuric acid is maintained between 30 ppm and 100 ppm.</text> </paragraph> <paragraph num="C."> <text>An owner or operator of a public pool or spa may not use:</text> <paragraph num="(1)"> <text>PHMB in a pool or spa that uses jets or sprays;</text> </paragraph> <paragraph num="(2)"> <text>PHMB in conjunction with any halogen compound or ozone;</text> </paragraph> <paragraph num="(3)"> <text>Cyanuric acid in conjunction with a bromine compound or in an indoor pool or spa; or</text> </paragraph> <paragraph num="(4)"> <text>An ultraviolet light/hydrogen peroxide system in conjunction with a diatomaceous earth filter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".45" heading="Water Chemistry of a Pool and Spa."> <paragraph num="A."> <text>An owner or operator shall ensure that the water chemistry of a public pool or spa is maintained according to the following requirements:</text> <paragraph num="(1)"> <text>The pH of the water is maintained between 7.2 and 7.8;</text> </paragraph> <paragraph num="(2)"> <text>The total alkalinity of the water is maintained between 60 ppm and 180 ppm;</text> </paragraph> <paragraph num="(3)"> <text>The calcium hardness of the water is maintained between 150 and 400 ppm;</text> </paragraph> <paragraph num="(4)"> <text>The Langelier Saturation Index of the water is maintained between -0.5 and +0.5 as calculated by:</text> <paragraph num="(a)"> <text>The Langelier Saturation Index formula: Langelier Saturation Index = pH + TF + CF + AF - 12.1 where: TF = temperature factor, CF = calcium hardness factor, and AF = alkalinity factor, and</text> </paragraph> <paragraph num="(b)"> <text>The following factor table:</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The amount of total dissolved solids is maintained so that it does not exceed 1,500 ppm, except for a salt water pool where the total dissolved solids may not exceed 3,000 ppm;</text> </paragraph> <paragraph num="(6)"> <text>The amount of dissolved metals is maintained so that it does not exceed the following levels:</text> <paragraph num="(a)"> <text>Iron, 0.3 ppm,</text> </paragraph> <paragraph num="(b)"> <text>Manganese, 0.3 ppm, and</text> </paragraph> <paragraph num="(c)"> <text>Copper, 1.3 ppm; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The water clarity is maintained so that either a 6 inch seechi disc placed in the deepest part of a pool or spa or the main drain is clearly visible and sharply defined when observed from the side of the pool or spa.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner or operator shall ensure that:</text> <paragraph num="(1)"> <text>Water additives and treatment chemicals are used according to manufacturers' instructions; and</text> </paragraph> <paragraph num="(2)"> <text>When chemicals are added directly to a pool or spa, no one is allowed in the water until the chemicals are dissolved and diffused throughout the pool or spa.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An owner or operator shall ensure that the water temperature for a heated public pool or spa does not exceed:</text> <paragraph num="(1)"> <text>88°F for a pool;</text> </paragraph> <paragraph num="(2)"> <text>104°F for a spa; and</text> </paragraph> <paragraph num="(3)"> <text>96°F for a therapy pool.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".46" heading="Operating Records Required."> <text>An operator shall maintain operating records on a form provided by the Secretary or an equivalent form and shall:</text> <paragraph num="A."> <text>Except as provided in §B of this regulation, record the information required in §C(1)—(3) of this regulation in 2-hour intervals for a recreational pool and for a public spa, and three times per day for a limited public-use and semipublic pool and record the information required in §C(4)—(9) of this regulation a minimum of three times per day for a public pool and spa, beginning 1/2 hour before opening;</text> </paragraph> <paragraph num="B."> <text>For a public pool or spa where an approved automatic controller is used, record the information required in §C of this regulation:</text> <paragraph num="(1)"> <text>A minimum of three times per day in conformance with the following schedule:</text> <paragraph num="(a)"> <text>The first recording of the day shall be made 1/2 hour before the pool or spa opens;</text> </paragraph> <paragraph num="(b)"> <text>The second recording shall be completed between 12 p.m. and 2 p.m.; and</text> </paragraph> <paragraph num="(c)"> <text>The final recording shall be completed 2 hours before closing; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>More frequently if required by the Secretary due to conditions such as high bather load, high temperatures, bright sunlight, or inadequate water quality;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Record the following information in the intervals required in §§A and B of this regulation:</text> <paragraph num="(1)"> <text>Disinfectant residual;</text> </paragraph> <paragraph num="(2)"> <text>Combined chlorine level, if chlorine is used;</text> </paragraph> <paragraph num="(3)"> <text>pH;</text> </paragraph> <paragraph num="(4)"> <text>Water clarity;</text> </paragraph> <paragraph num="(5)"> <text>Water temperature, if heated;</text> </paragraph> <paragraph num="(6)"> <text>Flow rate;</text> </paragraph> <paragraph num="(7)"> <text>Filter influent pressure and effluent pressure;</text> </paragraph> <paragraph num="(8)"> <text>Pump vacuum; and</text> </paragraph> <paragraph num="(9)"> <text>Total number of bathers;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Record in 1-week intervals for a public pool and in 1-day intervals for a public spa:</text> <paragraph num="(1)"> <text>Total alkalinity level;</text> </paragraph> <paragraph num="(2)"> <text>Calcium hardness level; and</text> </paragraph> <paragraph num="(3)"> <text>Cyanuric acid level, if used;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Record daily for a public pool or spa:</text> <paragraph num="(1)"> <text>The time of filter backwash or cleaning;</text> </paragraph> <paragraph num="(2)"> <text>An injury or accident at the pool or spa;</text> </paragraph> <paragraph num="(3)"> <text>Chemicals added to the water; and</text> </paragraph> <paragraph num="(4)"> <text>Malfunctioning or broken equipment;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Date and sign each record sheet;</text> </paragraph> <paragraph num="G."> <text>Record the results of the following inspections in the specified intervals to complete a Pool and Spa Entrapment Hazards Checklist:</text> <paragraph num="(1)"> <text>Daily check before the facility is open to verify that:</text> <paragraph num="(a)"> <text>Drain covers, vacuum fitting covers, skimmer equalizer covers, and any other suction outlet covers are in place, secure, and unbroken;</text> </paragraph> <paragraph num="(b)"> <text>Skimmer baskets, weirs, lids, flow adjusters, and suction outlet lines are free of any blockage;</text> </paragraph> <paragraph num="(c)"> <text>Inlet and return covers or fittings are in place, secure, and unbroken;</text> </paragraph> <paragraph num="(d)"> <text>Safety warning signs are in place around the pool or spa, including emergency instructions and phone numbers; and</text> </paragraph> <paragraph num="(e)"> <text>On/off switches for pumps are clearly labeled and the location of the pumps is clearly identified; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Check all information required in §G(1) of this regulation before filling a pool or spa with water, after periodic maintenance, and after pool or filter cleaning procedures;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Keep the records on the premises for a minimum of 3 years; and</text> </paragraph> <paragraph num="I."> <text>Submit the records to the Secretary upon request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".47" heading="Test Kits."> <paragraph num="A."> <text>In order to comply with the requirements of Regulation .46 of this chapter, an owner shall ensure that:</text> <paragraph num="(1)"> <text>One or more of the following for measuring the disinfectant level is used:</text> <paragraph num="(a)"> <text>A chlorine or bromine test kit that is the DPD (diethyl-p-phenylene diamine) reagent system for measuring free and combined chlorine or total bromine with an indicator range from 0.0 to 10.0 ppm or with procedures for performing a dilution test to achieve readings up to 10.0 ppm;</text> </paragraph> <paragraph num="(b)"> <text>An ozone test kit that is the indigo trisulfonate method for measuring ozone with an indicator range from 0.0 to 1.0 ppm;</text> </paragraph> <paragraph num="(c)"> <text>A copper test kit that is accurate to within +/- 0.1 ppm for measuring copper;</text> </paragraph> <paragraph num="(d)"> <text>A PHMB test kit with an indicator range from 0.0 ppm to 75 ppm; or</text> </paragraph> <paragraph num="(e)"> <text>A hydrogen peroxide test kit that is the DPD reagent system with an indicator range from 0.0 to 40 ppm;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A phenol red test is used to measure pH with an indicator range from at least 7.0 to 8.0;</text> </paragraph> <paragraph num="(3)"> <text>An alkalinity titration test is used to measure alkalinity as milligrams per liter calcium carbonate;</text> </paragraph> <paragraph num="(4)"> <text>An EDTA (ethylenediamine-tetraacetate) hardness test is used to measure calcium hardness as milligrams per liter calcium carbonate; and</text> </paragraph> <paragraph num="(5)"> <text>A cyanuric acid test kit with an indicator range from 0 to 100 ppm is used if cyanuric acid is used in the pool or spa.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to comply with the requirements of Regulation .46 of this chapter, an owner may monitor:</text> <paragraph num="(1)"> <text>Chlorine and bromine residuals by measuring the oxidation-reduction potential (ORP) of the water before the disinfectant injection point; and</text> </paragraph> <paragraph num="(2)"> <text>The pH with a pH meter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an ORP or pH meter is used, an owner shall ensure that:</text> <paragraph num="(1)"> <text>Periodic calibration is performed on these instruments to assure accurate measurements; and</text> </paragraph> <paragraph num="(2)"> <text>Manual measurements are performed on a daily basis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".48" heading="Sanitary Quality of Water."> <text>Although routine testing is not required, an owner shall ensure that the water in a public pool or spa:</text> <paragraph num="A."> <text>Has a coliform bacteria level of less than 1 coliform per milliliter; and</text> </paragraph> <paragraph num="B."> <text>Is free of pathogenic organisms.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".49" heading="Chemical Handling and Storage."> <text>An owner shall ensure that a:</text> <paragraph num="A."> <text>Material safety data sheet for a potentially hazardous chemical is available to the operator;</text> </paragraph> <paragraph num="B."> <text>Chemical is handled, used, stored, and disposed of in accordance with the material safety data sheet and all applicable federal, State, and local codes; and</text> </paragraph> <paragraph num="C."> <text>Chemical is stored in a chemical storage area which is in compliance with Regulation .29 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".50" heading="Control of Infectious and Contagious Diseases."> <paragraph num="A."> <text>An owner may not knowingly permit an individual to enter the water of a public pool or spa who has:</text> <paragraph num="(1)"> <text>An infectious or contagious disease that may be transmitted through water;</text> </paragraph> <paragraph num="(2)"> <text>An open cut, blister, or other lesion; or</text> </paragraph> <paragraph num="(3)"> <text>Diarrhea.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner or operator may not prohibit an individual from entering the water of a public pool or spa if a physician certifies that the individual's condition is not infectious or contagious by waterborne transmission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".51" heading="Injury and Illness Reports."> <text>A public pool or spa owner shall ensure that:</text> <paragraph num="A."> <text>An injury, drowning, near drowning, or suction entrapment occurring at a pool or spa that results in death or that requires resuscitation or admission to a hospital is reported to the Secretary within 24 hours of the incident;</text> </paragraph> <paragraph num="B."> <text>A waterborne illness contracted at a pool or spa is reported to the Secretary within 24 hours of the owner's or operator's knowledge of the incident;</text> </paragraph> <paragraph num="C."> <text>A water rescue by aquatic safety personnel is reported to the Secretary every 3 months during operation or at the seasonal closure of the facility, whichever is more frequent; and</text> </paragraph> <paragraph num="D."> <text>The information required in §§A—C of this regulation is recorded on a pool and spa injury and illness report form provided by the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".52" heading="Disinfection of Swimsuits and Towels."> <text>An owner shall ensure that a swimsuit or towel furnished to an individual by the owner or operator of a public pool or spa is:</text> <paragraph num="A."> <text>Washed in a washing machine with laundry detergent in hot water with a temperature of at least 175?F; and</text> </paragraph> <paragraph num="B."> <text>Rinsed in an effective disinfectant or heat dried at 175?F or more for at least 30 minutes after being washed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".53" heading="Variances."> <paragraph num="A."> <text>An owner who has been granted a variance by the Secretary before February 10, 1997 may continue to operate under that variance.</text> </paragraph> <paragraph num="B."> <text>An owner may request a variance from a requirement of this chapter by submitting a written application that:</text> <paragraph num="(1)"> <text>Contains specific details of the alternative procedure proposed by the owner;</text> </paragraph> <paragraph num="(2)"> <text>Specifies the applicable regulation to which the variance pertains;</text> </paragraph> <paragraph num="(3)"> <text>Explains the reason for the request;</text> </paragraph> <paragraph num="(4)"> <text>Provides the name and address of the owner;</text> </paragraph> <paragraph num="(5)"> <text>Provides the name and location of the facility; and</text> </paragraph> <paragraph num="(6)"> <text>Demonstrates that the alternative procedure proposed:</text> <paragraph num="(a)"> <text>Meets or produces the intended effect of the regulation for which the variance is requested, and</text> </paragraph> <paragraph num="(b)"> <text>Maintains the protection of the health and safety of the individuals using the facility at or above the level required by the regulation for which the variance is requested.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Upon consideration of an application for a variance, the Secretary may grant the request for a variance if the:</text> <paragraph num="(1)"> <text>Applicant has submitted an application in accordance with the provisions of §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Applicant has complied with all other applicable provisions of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Application is justified due to physical limitation of the existing layout of the facility; and</text> </paragraph> <paragraph num="(4)"> <text>Secretary determines that the alternative procedure proposed by the applicant:</text> <paragraph num="(a)"> <text>Meets or produces the intended effect of the regulation, and</text> </paragraph> <paragraph num="(b)"> <text>Maintains the protection of the health and safety of the individuals using the facility at or above the level required by the regulation at issue.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary shall grant or deny an application for a variance in writing and shall mail the decision to the applicant within 60 days of the date the application for a variance is received by the Department.</text> </paragraph> <paragraph num="E."> <text>If the determination of the Secretary is to deny a variance request that has been made in compliance with the provisions of §B of this regulation, the applicant may file an appeal of the denial in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and shall contact the Secretary within 10 days of receipt of the denial to preserve a right to a hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".54" heading="Compliance Schedules."> <paragraph num="A."> <text>The owner of a public pool or spa that has a structure, equipment, or appurtenance that is not in compliance with this chapter as determined by the Secretary may submit to the Secretary for approval a compliance schedule for meeting the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The request from an owner for approval of a compliance schedule shall include:</text> <paragraph num="(1)"> <text>The reason that the noncompliance item cannot be immediately corrected;</text> </paragraph> <paragraph num="(2)"> <text>The plan for correction of the noncompliance item; and</text> </paragraph> <paragraph num="(3)"> <text>The time schedule for the correction of the noncompliance item.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may approve the compliance schedule if the:</text> <paragraph num="(1)"> <text>Owner has submitted a written request for approval of a compliance schedule in accordance with §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Time schedule for the correction of the noncompliance item is accepted by the Secretary; and</text> </paragraph> <paragraph num="(3)"> <text>Operation of the pool or spa during the time allowed to bring the pool or spa into compliance does not adversely affect the health and safety of the public.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Secretary may not approve a compliance schedule for a newly constructed pool or spa that has not received construction approval under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="E."> <text>The Secretary shall issue an operating permit or shall refrain from suspending an operating permit to an owner if:</text> <paragraph num="(1)"> <text>A compliance schedule has been approved by the Secretary for the correction of a noncompliance item;</text> </paragraph> <paragraph num="(2)"> <text>The owner is following the approved compliance schedule; and</text> </paragraph> <paragraph num="(3)"> <text>The pool or spa is otherwise in compliance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".55" heading="Standardization and Audits of Local Health Departments."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Standardize one employee related to the enforcement of this chapter for each local health department to serve as the local standardization officer;</text> </paragraph> <paragraph num="(2)"> <text>Audit local health department pool and spa programs related to the enforcement of this chapter once every 4 years according to the current audit protocols; and</text> </paragraph> <paragraph num="(3)"> <text>Provide to the local health department a pool and spa program review final report.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Local health departments shall submit to the Department responses to any deficiencies within the pool and spa program as identified within the pool and spa program review final report within 30 business days of receipt of the report.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-102, 2-104, 18-102, and 20-303, Annotated Code of Maryland, and 15 U.S.C. §8003</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 10, 1997 (24:3 Md. R. 187)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 1, 1999 (26:16 Md. R. 1238); amended permanently effective December 13, 1999 (26:25 Md. R. 1898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 20, 2000 (27:5 Md. R. 584); December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective December 19, 2008 (36:4 Md. R. 345); amended permanently effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 20, 2000 (27:5 Md. R. 584); December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective December 19, 2008 (36:4 Md. R. 345); amended permanently effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective November 2, 2020 (47:10 Md. R. 517); October 1, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521); November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-1 adopted effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective March 20, 2000 (27:5 Md. R. 584); December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C adopted effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13C amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16C, D amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C, D amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective October 1, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25C amended effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25G adopted effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27F amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective March 20, 2000 (27:5 Md. R. 584); December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended as an emergency provision effective December 19, 2008 (36:4 Md. R. 345); amended permanently effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28F, G amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H amended effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35A amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .40 amended effective March 20, 2000 (27:5 Md. R. 584); December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .41B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .43 amended effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .43B amended effective November 2, 2020 (47:10 Md. R. 517)</annotation> <annotation type="History" subtype="Administrative History">Regulation .46 amended effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .53A amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .55 adopted effective November 2, 2020 (47:10 Md. R. 517)</annotation> </annotations> </chapter> <chapter num="02" heading="Automated External Defibrillators for Swimming Pools"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes guidelines for periodic inspections and annual maintenance of the automated external defibrillators at swimming pools.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“AED” means automated external defibrillator as defined in COMAR 30.06.01.01.</text> </paragraph> <paragraph num="(2)"> <text>“AED coordinator” means an individual designated by the county or municipality to meet the requirement of COMAR 30.06.02.</text> </paragraph> <paragraph num="(3)"> <text>“Swimming pool” means a pool that is owned and operated by the governing body of a county or municipality.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="AED Program Requirements."> <text>Each county or municipality that owns and operates a swimming pool shall develop and implement an automated external defibrillator program that meets the requirements in the Education Article, §13-517, Annotated Code of Maryland, and COMAR 30.06.02.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Installation."> <text>An AED shall be located within the pool barrier, as defined in COMAR 10.17.01.05.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration."> <text>Each swimming pool owned and operated by a county or municipality shall be registered as specified in COMAR 30.06.02.04.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Training."> <text>The AED coordinator shall ensure that at least one individual who has a current AED certification from a national organization is onsite while the swimming pool is open.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Quality Assurance and Maintenance."> <text>A county or municipality that owns and operates a swimming pool shall:</text> <paragraph num="A."> <text>Maintain the certificate, equipment and supplies as required by COMAR 30.06.02; and</text> </paragraph> <paragraph num="B."> <text>Submit the reports as required by COMAR 30.06.02 to the Maryland Institute for Emergency Medical Services Systems (MIEMSS).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inspections."> <paragraph num="A."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Monitor a swimming pool for compliance with this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Inspect the swimming pool as necessary for the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Right to Inspect.</text> <paragraph num="(1)"> <text>The Department may enter, at reasonable times, the property of a swimming pool for the purposes of inspecting, monitoring, and verifying information relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A person may not deny or interfere with the Department’s entry into a swimming pool under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An operator shall permit a representative of the Department to examine and copy records of the swimming pool to verify information relative to the enforcement of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Report of Inspection. During a swimming pool inspection, the Department shall:</text> <paragraph num="(1)"> <text>Record the inspection results on an inspection form prescribed by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Identify on the inspection form the conditions found that violate the provisions of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Notify the swimming pool operator on the inspection form to correct violations by a specific date; and</text> </paragraph> <paragraph num="(4)"> <text>Provide one copy of the inspection report to the swimming pool operator.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The completed inspection report is a public document that is available for public disclosure in accordance with State Government Article, §§10-611 — 10-628, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Local Government Article, §1-1310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 7, 2014 (41:13 Md. R. 752)</annotation> </annotations> </chapter> <chapter num="03" heading="" reason="VACANT" /> <chapter num="04" heading="Public Swimming Pools" reason="Repealed — See COMAR 10.17.01"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 26, 1951</annotation> <annotation type="History" subtype="Administrative History">Amended effective June 1, 1967; December 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 20, 1978 (5:21 Md. R. 1587)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 13, 1991 (18:9 Md. R. 1012)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective February 10, 1997 (24:3 Md. R. 187)</annotation> </annotations> </chapter> </subtitle> <subtitle num="18" heading="Human Immunodeficiency Virus (HIV) Infection and Acquired Immunodeficiency Syndrome (AIDS)"> <chapter num="01" heading="Maryland AIDS Drug Assistance Program: Temporary Assistance Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of the Maryland AIDS Drug Assistance Program’s Temporary Assistance Program is to provide short term assistance to individuals with Human Immunodeficiency Virus (HIV) who:</text> <paragraph num="A."> <text>Need HIV drugs and other products;</text> </paragraph> <paragraph num="B."> <text>Have an application for Medical Assistance or Low-Income Subsidy pending; and</text> </paragraph> <paragraph num="C."> <text>Are considered likely to have their application approved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.</text> </paragraph> <paragraph num="(2)"> <text>“Agent” means a case manager, licensed social worker, registered nurse, or any other related professional that assists an individual in submitting an application to the Temporary Assistance Program.</text> </paragraph> <paragraph num="(3)"> <text>“Applicant” means an individual on whose behalf an application has been submitted to the Temporary Assistance Program and whose eligibility status for the Temporary Assistance Program has not yet been determined.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration, and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04.</text> </paragraph> <paragraph num="(6)"> <text>“Enrollment period” means the period of time a recipient may receive Temporary Assistance Program benefits.</text> </paragraph> <paragraph num="(7)"> <text>“Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.</text> </paragraph> <paragraph num="(8)"> <text>“Human immunodeficiency virus (HIV)” means the virus that causes AIDS.</text> </paragraph> <paragraph num="(9)"> <text>“Low-Income Subsidy (LIS)” means the federal program available under the Medicare Part D prescription drug program and Medicare advantage plans that assists persons who have limited income to pay for the cost of premiums, deductibles, and copayments.</text> </paragraph> <paragraph num="(10)"> <text>“Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance” has the meaning specified in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(12)"> <text>“Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department per COMAR 10.18.06.04-1.</text> </paragraph> <paragraph num="(13)"> <text>“Recipient” means an individual who is enrolled in the Temporary Assistance Program.</text> </paragraph> <paragraph num="(14)"> <text>“Resident” means an individual:</text> <paragraph num="(a)"> <text>Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and</text> </paragraph> <paragraph num="(b)"> <text>For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of residence.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Temporary Assistance Program (TAP)” means the program administered by the Department that provides short term MADAP services as specified in Regulation .05 of this chapter for low income eligible individuals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Eligibility."> <text>To be eligible for benefits, an individual shall meet the following criteria:</text> <paragraph num="A."> <text>Be a resident of Maryland;</text> </paragraph> <paragraph num="B."> <text>Be infected with HIV; and</text> </paragraph> <paragraph num="C."> <text>Have a pending application to Medical Assistance or LIS.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application and Enrollment."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>The agent of the applicant shall submit a completed TAP application to the Department on the form designated by the Department that includes:</text> <paragraph num="(a)"> <text>Responses to all applicable questions; and</text> </paragraph> <paragraph num="(b)"> <text>A copy of the completed application or other verifiable documentation for Medical Assistance or LIS enrollment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The agent of the applicant or the applicant may voluntarily withdraw the application at any time without prejudice.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Review and process a TAP application by the end of the first business day following receipt;</text> </paragraph> <paragraph num="(b)"> <text>Approve a TAP application if the:</text> <paragraph num="(i)"> <text>TAP application is complete;</text> </paragraph> <paragraph num="(ii)"> <text>Applicant is determined to be eligible; and</text> </paragraph> <paragraph num="(iii)"> <text>Department is able to ascertain that the applicant will likely be found eligible for Medical Assistance or LIS;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Issue a client identification number if the TAP application is approved;</text> </paragraph> <paragraph num="(d)"> <text>Disapprove a TAP application if the:</text> <paragraph num="(i)"> <text>TAP application is incomplete; or</text> </paragraph> <paragraph num="(ii)"> <text>Agent of the applicant fails to provide sufficient information or documentation to determine eligibility; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Contact the agent of the applicant with the status of the TAP application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Enrollment.</text> <paragraph num="(1)"> <text>A recipient shall be approved for coverage beginning the first day of the month in which the:</text> <paragraph num="(a)"> <text>TAP application was received; or</text> </paragraph> <paragraph num="(b)"> <text>Recipient will need access to medications through TAP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Benefits shall end on the date that a determination of Medical Assistance or LIS coverage occurs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <paragraph num="A."> <text>The recipient shall obtain a prescription for each drug or other product ordered for the recipient.</text> </paragraph> <paragraph num="B."> <text>The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Recovery of Payments."> <text>If benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Fraud."> <text>The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Confidentiality."> <text>Except when communicating with the parties listed in §B of this regulation and unless otherwise authorized by law, the agent of an applicant, or the agent of a recipient, the Department:</text> <paragraph num="A."> <text>Shall keep all applicant and recipient personal information confidential;</text> </paragraph> <paragraph num="B."> <text>May not disclose personal information kept on an applicant or recipient without written consent of the:</text> <paragraph num="(1)"> <text>Applicant;</text> </paragraph> <paragraph num="(2)"> <text>Recipient;</text> </paragraph> <paragraph num="(3)"> <text>Applicant’s parent or legal guardian; or</text> </paragraph> <paragraph num="(4)"> <text>Recipient’s parent or legal guardian;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall comply with the laws and regulations concerning the privacy and security of protected health information under:</text> <paragraph num="(1)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Availability of Funding and Program Termination."> <paragraph num="A."> <text>If sufficient monies are not available to fund TAP, the Department shall take the action necessary to eliminate a deficit which may include program termination.</text> </paragraph> <paragraph num="B."> <text>If TAP is terminated, the Department shall provide benefits for each current recipient in accordance with Regulation .04B of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="02" heading="HIV and CD4+ Investigations and Case Reporting"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes the requirements for:</text> <paragraph num="(1)"> <text>Physician reporting of a:</text> <paragraph num="(a)"> <text>Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and</text> </paragraph> <paragraph num="(b)"> <text>Birth of an infant whose mother has tested positive for HIV;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Institution reporting of a case of HIV or AIDS;</text> </paragraph> <paragraph num="(3)"> <text>Laboratory reporting of a test result for:</text> <paragraph num="(a)"> <text>HIV detection;</text> </paragraph> <paragraph num="(b)"> <text>HIV viral load;</text> </paragraph> <paragraph num="(c)"> <text>CD4+ cell count or percentage; or</text> </paragraph> <paragraph num="(d)"> <text>HIV genotype sequence; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Follow-up of:</text> <paragraph num="(a)"> <text>A physician's report of HIV or AIDS;</text> </paragraph> <paragraph num="(b)"> <text>A physician's report of an infant whose mother has tested positive for HIV;</text> </paragraph> <paragraph num="(c)"> <text>An institution's report of HIV or AIDS; and</text> </paragraph> <paragraph num="(d)"> <text>A laboratory’s report of a test result for:</text> <paragraph num="(i)"> <text>HIV detection;</text> </paragraph> <paragraph num="(ii)"> <text>HIV viral load;</text> </paragraph> <paragraph num="(iii)"> <text>CD4+ cell count or percentage; or</text> </paragraph> <paragraph num="(iv)"> <text>HIV genotype sequence infection or CD4+ count.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for:</text> <paragraph num="(1)"> <text>HIV detection;</text> </paragraph> <paragraph num="(2)"> <text>HIV viral load;</text> </paragraph> <paragraph num="(3)"> <text>CD4+ cell count or percentage; or</text> </paragraph> <paragraph num="(4)"> <text>HIV genotype sequence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter does not apply if the specimen from a human body is:</text> <paragraph num="(1)"> <text>Not tested for:</text> <paragraph num="(a)"> <text>HIV detection;</text> </paragraph> <paragraph num="(b)"> <text>HIV viral load;</text> </paragraph> <paragraph num="(c)"> <text>CD4+ cell count or percentage; or</text> </paragraph> <paragraph num="(d)"> <text>HIV genotype sequence;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue;</text> </paragraph> <paragraph num="(3)"> <text>Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test;</text> </paragraph> <paragraph num="(4)"> <text>Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions:</text> <paragraph num="(a)"> <text>All personal identifiers are removed from the specimen before testing;</text> </paragraph> <paragraph num="(b)"> <text>The specimen cannot be linked to the individual from whom the specimen was taken;</text> </paragraph> <paragraph num="(c)"> <text>The result cannot be linked to the individual from whom the specimen was taken; and</text> </paragraph> <paragraph num="(d)"> <text>The research protocol has been approved by an institutional review board;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Taken from a patient known to reside outside of the United States; or</text> </paragraph> <paragraph num="(7)"> <text>Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Exemptions."> <paragraph num="A."> <text>Qualifications for Exemption. A research project that meets both of the following criteria may be eligible for exemption from the HIV reporting requirements of Regulation .06 of this chapter:</text> <paragraph num="(1)"> <text>The research project has been approved by an institutional review board; and</text> </paragraph> <paragraph num="(2)"> <text>The research:</text> <paragraph num="(a)"> <text>Is intended to determine the safety or effectiveness of a vaccine that would produce immunity against HIV; or</text> </paragraph> <paragraph num="(b)"> <text>Is not primarily intended to provide medical treatment to participants.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Application for Exemption. The principal investigator of a research project shall submit all of the following documents to the Department in order to apply for an exemption:</text> <paragraph num="(1)"> <text>A copy of the research protocol approved by the institutional review board of the institution conducting the research; and</text> </paragraph> <paragraph num="(2)"> <text>A copy of the notice stating that the protocol has been approved by the institutional review board of the institution conducting the research.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Approval.</text> <paragraph num="(1)"> <text>The Director of the Infectious Disease Prevention and Health Services Bureau or the Director’s designee shall review the application submitted under §B of this regulation to determine whether the:</text> <paragraph num="(a)"> <text>Application is complete; and</text> </paragraph> <paragraph num="(b)"> <text>Research protocol meets the criteria specified in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the application is complete and the research protocol meets the specified criteria, the Director shall grant an exemption from the requirements set forth in Regulation .06 of this chapter for any specimen tested for HIV detection under the research project approved for exemption.</text> </paragraph> <paragraph num="(3)"> <text>The Director shall mail written notification to the applicant of an exemption under this regulation within 30 days of receipt of the application, stating whether the exemption:</text> <paragraph num="(a)"> <text>Has been approved;</text> </paragraph> <paragraph num="(b)"> <text>Has been denied and the reason for the denial; or</text> </paragraph> <paragraph num="(c)"> <text>Cannot be processed until further information is provided to the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Responsibilities of the Principal Investigator. If a research project is granted an exemption under §C of this regulation, the principal investigator of the research project shall send to each laboratory to which specimens collected under the research protocol will be sent to be tested for HIV detection a copy of the notification from the Director issued pursuant to §C(3)(a) of this regulation to verify that the project has been exempted from the reporting requirements of Regulation .06 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Scope of Exemption.</text> <paragraph num="(1)"> <text>Except as indicated in §E(2) of this regulation, an exemption approved under §C of this regulation does not relieve the principal investigator, a laboratory director, or another individual from a reporting requirement contained in Health-General Article, §18-201.1, 18-202.1, 18-205, or 18-207, Annotated Code of Maryland, or Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A principal investigator, laboratory director, or other individual is not required to report HIV detection test results if the test is done as part of the research project and the individual tested:</text> <paragraph num="(a)"> <text>Meets the criteria for participation in the research project set forth in the research protocol submitted under §B(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Has signed an informed consent form agreeing to participate in the research project.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired immunodeficiency syndrome (AIDS)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Anonymous” means that a patient does not use the patient's name as identification and can only be identified through use of a code.</text> </paragraph> <paragraph num="(3)"> <text>“Assigned laboratory number” means a number assigned to a laboratory by the Department for use in filing reports of HIV infection or CD4+ count.</text> </paragraph> <paragraph num="(4)"> <text>“Case” means an individual who has:</text> <paragraph num="(a)"> <text>Been clinically diagnosed as having HIV or AIDS; or</text> </paragraph> <paragraph num="(b)"> <text>Laboratory evidence of being infected by HIV.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Clinical material” means:</text> <paragraph num="(a)"> <text>An organism isolated from a clinical specimen;</text> </paragraph> <paragraph num="(b)"> <text>Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or</text> </paragraph> <paragraph num="(c)"> <text>If neither §B(5)(a) nor §B(5)(b) of this regulation is available, material from an individual already held by the medical laboratory, in the following order of preference:</text> <paragraph num="(i)"> <text>A patient specimen;</text> </paragraph> <paragraph num="(ii)"> <text>Nucleic acid; or</text> </paragraph> <paragraph num="(iii)"> <text>Other laboratory material.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Clinical or infection control practitioner” means a physician, infection control nurse, physician assistant, nurse practitioner, or other clinical staff designated by the administrative head of an institution to report under Health-General Article, §18-202.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Designated anonymous HIV test site” means an HIV counseling and testing site designated by the Department as a site where a patient may have an anonymous HIV test.</text> </paragraph> <paragraph num="(9)"> <text>“Drug” means a drug that has been:</text> <paragraph num="(a)"> <text>Licensed by the United States Food and Drug Administration (FDA); or</text> </paragraph> <paragraph num="(b)"> <text>Approved by the FDA as an investigational new drug.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Exemption” means a research project meeting certain criteria, with the result that no reporting is required under this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City or the duly designated representative of the health officer.</text> </paragraph> <paragraph num="(12)"> <text>“Human immunodeficiency virus (HIV)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Institution” means an entity that employs an individual licensed to practice osteopathy or medicine by the State.</text> </paragraph> <paragraph num="(14)"> <text>“Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46 to review the use of human subjects in proposed research.</text> </paragraph> <paragraph num="(15)"> <text>“Laboratory examination order” means the written document signed by a physician or other authorized individual that specifies one or more laboratory examinations to be performed in regard to a specified patient.</text> </paragraph> <paragraph num="(16)"> <text>“Newborn HIV exposure” means a newborn infant whose mother has tested positive for HIV infection.</text> </paragraph> <paragraph num="(17)"> <text>“Physician” means an individual licensed to practice osteopathy or medicine by the State or the physician's designee working under the supervision of the physician.</text> </paragraph> <paragraph num="(18)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Physician Responsibility."> <paragraph num="A."> <text>A physician shall:</text> <paragraph num="(1)"> <text>Report a case of HIV or AIDS or newborn HIV exposure for a patient under the physician's care to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and</text> </paragraph> <paragraph num="(2)"> <text>Include the information requested on the form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician may not transmit information to the health officer or the Secretary about a case of HIV or AIDS or newborn HIV exposure by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.</text> </paragraph> <paragraph num="C."> <text>A physician authorized to order laboratory examinations shall include all of the following information on the written laboratory examination order for a test covered by this chapter:</text> <paragraph num="(1)"> <text>Name, date of birth, race, ethnicity, and gender of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Street address, city, state, and zip code of the patient's residence; and</text> </paragraph> <paragraph num="(3)"> <text>Name, address, and telephone number of the physician ordering the test.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A physician who reports a case of HIV or AIDS or a newborn HIV exposure or orders a laboratory examination for a test covered by this chapter shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>A physician working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report an HIV or AIDS case if the administrative head of the institution has designated an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners other than the physician to be responsible for reporting on behalf of all clinical and infection control practitioners in the facility, as set forth in Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of Clinical and Infection Control Practitioners in Institutions."> <paragraph num="A."> <text>A clinical or infection control practitioner working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, shall:</text> <paragraph num="(1)"> <text>Report a case of HIV or AIDS under the care of the institution to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and</text> </paragraph> <paragraph num="(2)"> <text>Include the information requested on the form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A clinical or infection control practitioner may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.</text> </paragraph> <paragraph num="C."> <text>A clinical or infection control practitioner who reports a case of HIV or AIDS shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as defined in Health-General Article, §18-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The administrative head of an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, may designate an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical and infection control practitioners in the facility.</text> </paragraph> <paragraph num="E."> <text>A clinical or infection control practitioner working in an institution required to report as defined in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report HIV or AIDS cases if the administrative head of the institution has designated a different individual clinical or infection control practitioner or specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical practitioners in the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Responsibilities of Laboratory Directors."> <paragraph num="A."> <text>Except as provided in Regulations .01C and .02 of this chapter, the director of a medical laboratory shall:</text> <paragraph num="(1)"> <text>Submit a report to the health officer for the jurisdiction where the laboratory is located, within 48 hours after an examination of a specimen from a human body shows one of the following:</text> <paragraph num="(a)"> <text>A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results;</text> </paragraph> <paragraph num="(b)"> <text>A quantitative or qualitative HIV viral load test result, including undetectable;</text> </paragraph> <paragraph num="(c)"> <text>A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or</text> </paragraph> <paragraph num="(d)"> <text>An HIV genotype sequence test result;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Use the form provided by the Department in making the report required under §A(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Include all of the following information in the report required under §A(1) of this regulation:</text> <paragraph num="(a)"> <text>Name and address of laboratory or assigned laboratory number;</text> </paragraph> <paragraph num="(b)"> <text>Date the specimen was obtained from the patient;</text> </paragraph> <paragraph num="(c)"> <text>Type and result of laboratory test, that is, HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence;</text> </paragraph> <paragraph num="(d)"> <text>Name, date of birth, race, ethnicity, and gender of the patient;</text> </paragraph> <paragraph num="(e)"> <text>Street address, city, state, and zip code of the patient's residence;</text> </paragraph> <paragraph num="(f)"> <text>Name of the physician authorizing the laboratory examination; and</text> </paragraph> <paragraph num="(g)"> <text>Address and telephone number of the physician authorizing the laboratory examination; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Contact the physician authorizing the laboratory examination to obtain any of the information, as required by §A(3) of this regulation, that is not provided on the laboratory examination order.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A laboratory director may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.</text> </paragraph> <paragraph num="C."> <text>The laboratory director shall, at the request of the Secretary, make available to the Secretary any remaining clinical material from tested individuals.</text> </paragraph> <paragraph num="D."> <text>This regulation does not relieve a physician of the duty to report as set forth in Health-General Article, §§18-201.1 and 18-202.1, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Out-of-State Laboratories."> <text>An out-of-State laboratory that holds a permit to operate issued by Maryland and performs HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence tests shall submit the report required under Regulation .06 of this chapter to the Secretary.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsibility of Health Officer."> <paragraph num="A."> <text>This regulation establishes requirements for follow-up by the health officer of a report of HIV or AIDS or newborn HIV exposure or laboratory report of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence.</text> </paragraph> <paragraph num="B."> <text>This regulation does not supplant or otherwise modify the:</text> <paragraph num="(1)"> <text>Physician's obligation to report a case of HIV or AIDS or newborn HIV exposure under Health-General Article, §18-201.1, Annotated Code of Maryland, and Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Clinical or infection control practitioner's obligation to report a case of HIV or AIDS under Health-General Article, §18-202.1, Annotated Code of Maryland, and Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Laboratory director’s obligation to report a test result of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence under Health-General Article, §18-205, Annotated Code of Maryland, and Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon receipt of a report from a physician pursuant to Regulation .04 of this chapter, a clinical or infection control practitioner pursuant to Regulation .05 of this chapter, the health officer shall:</text> <paragraph num="(1)"> <text>Determine whether the case of HIV, the case of AIDS, or the newborn HIV exposure has been reported previously;</text> </paragraph> <paragraph num="(2)"> <text>Complete the case investigation if the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon receipt of a test result report from a laboratory director pursuant to Regulation .06 of this chapter, the health officer shall:</text> <paragraph num="(1)"> <text>Determine whether the report matches to a case of HIV, a case of AIDS, or a newborn HIV exposure that has been reported previously, and submit the report to the Department if the report matches;</text> </paragraph> <paragraph num="(2)"> <text>Complete a case investigation if the report indicates the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously;</text> </paragraph> <paragraph num="(3)"> <text>Submit the case report, as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and</text> </paragraph> <paragraph num="(4)"> <text>Retain a nonmatching report for up to 4 years, rematching the report, not less than annually, to test result reports and to cases of HIV or cases of AIDS or newborn HIV exposures that had not been reported previously, to identify new matches, and submit the report to the Department if the report matches.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A health officer may not transmit to the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Record Maintenance and Confidentiality."> <paragraph num="A."> <text>A person that submitted a report of HIV or AIDS or newborn HIV exposure shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04—.06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Except for a designated anonymous HIV test site, a person that ordered the laboratory examination shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04 and .05 of this chapter, upon receipt of one of the following:</text> <paragraph num="(1)"> <text>A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results;</text> </paragraph> <paragraph num="(2)"> <text>A qualitative or quantitative HIV viral load test result, including undetectable;</text> </paragraph> <paragraph num="(3)"> <text>A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or</text> </paragraph> <paragraph num="(4)"> <text>An HIV genotype sequence test result.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Confidentiality.</text> <paragraph num="(1)"> <text>A report required under this chapter is:</text> <paragraph num="(a)"> <text>Confidential;</text> </paragraph> <paragraph num="(b)"> <text>Not open to public inspection;</text> </paragraph> <paragraph num="(c)"> <text>Not a medical record under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>Subject to the confidentiality requirements of Health-General Article, Title 4, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The reports and any proceedings, records, or files relating to the reports required under this chapter are not discoverable and are not admissible in evidence in any civil action.</text> </paragraph> <paragraph num="(3)"> <text>Section C(1) of this regulation does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties pursuant to State or federal law where the Secretary determines that the agency to whom the information is disclosed will maintain the confidentiality of the disclosure.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;State Government Article, §10-617; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 8, 2008 (35:18 Md. R. 1600)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> </annotations> </chapter> <chapter num="03" heading="AIDS Investigations and Case Reporting" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed effective May 18, 2020 (47:10 Md. R. 518)</annotation> </annotations> </chapter> <chapter num="04" heading="Disease Control" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 repealed effective April 24, 2017 (44:8 Md. R. 403)</annotation> </annotations> </chapter> <chapter num="05" heading="Maryland AIDS Drug Assistance Program: Eligibility"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program and whose eligibility status for the Maryland AIDS Drug Assistance Program has not yet been determined.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Disenroll” means to end Maryland AIDS Drug Assistance Program benefits.</text> </paragraph> <paragraph num="(5)"> <text>“Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04.</text> </paragraph> <paragraph num="(6)"> <text>“Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.</text> </paragraph> <paragraph num="(7)"> <text>“Gross household income” means the income derived from sources provided in Regulation .02E of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.</text> </paragraph> <paragraph num="(9)"> <text>“Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS.</text> </paragraph> <paragraph num="(10)"> <text>“Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.</text> </paragraph> <paragraph num="(11)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(12)"> <text>“Recipient” means an individual who is enrolled in MADAP.</text> </paragraph> <paragraph num="(13)"> <text>“Resident” means an individual:</text> <paragraph num="(a)"> <text>Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and</text> </paragraph> <paragraph num="(b)"> <text>For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of the residence.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to Regulation .03B(1)(a) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility."> <paragraph num="A."> <text>Except when an individual is enrolled in Medical Assistance but does not have prescription coverage assistance, an individual who is eligible for Medical Assistance is not eligible for MADAP.</text> </paragraph> <paragraph num="B."> <text>To be eligible for benefits, an individual shall meet the following criteria:</text> <paragraph num="(1)"> <text>Residency;</text> </paragraph> <paragraph num="(2)"> <text>Medical; and</text> </paragraph> <paragraph num="(3)"> <text>Financial.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Residency Criteria. To meet the residency criteria the individual shall be a resident of Maryland.</text> </paragraph> <paragraph num="D."> <text>Medical Criteria. To meet the medical criteria the individual shall be infected with HIV as verified by the Department.</text> </paragraph> <paragraph num="E."> <text>Financial Criteria.</text> <paragraph num="(1)"> <text>To meet the financial criteria the individual shall have a projected gross household income less than or equal to 500 percent of the Federal Poverty Level Guidelines as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2).</text> </paragraph> <paragraph num="(2)"> <text>Projected gross household income shall be determined based on what can reasonably be expected to be received during the 12-month period beginning with the month in which the completed application is filed or verification of eligibility is submitted.</text> </paragraph> <paragraph num="(3)"> <text>Gross household income includes income derived from:</text> <paragraph num="(a)"> <text>Wages and salaries, including tips;</text> </paragraph> <paragraph num="(b)"> <text>Net income from self-employment or business;</text> </paragraph> <paragraph num="(c)"> <text>Unemployment income;</text> </paragraph> <paragraph num="(d)"> <text>Social security payments, including disability payments;</text> </paragraph> <paragraph num="(e)"> <text>Alimony;</text> </paragraph> <paragraph num="(f)"> <text>Retirement income;</text> </paragraph> <paragraph num="(g)"> <text>Pension income;</text> </paragraph> <paragraph num="(h)"> <text>Investment income;</text> </paragraph> <paragraph num="(i)"> <text>Rental income; and</text> </paragraph> <paragraph num="(j)"> <text>Other taxable income, such as prizes, awards, and gambling winnings.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Gross household income under this chapter does not include income derived from:</text> <paragraph num="(a)"> <text>Child support;</text> </paragraph> <paragraph num="(b)"> <text>Gifts;</text> </paragraph> <paragraph num="(c)"> <text>Supplemental Social Security Income;</text> </paragraph> <paragraph num="(d)"> <text>Veterans’ disability payments;</text> </paragraph> <paragraph num="(e)"> <text>Workers’ compensation; and</text> </paragraph> <paragraph num="(f)"> <text>Proceeds from loans, such as student loans, home equity loans, or bank loans.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application and Enrollment."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>Applicant.</text> <paragraph num="(a)"> <text>An applicant shall submit a completed application to the Department on the form designated by the Department that includes:</text> <paragraph num="(i)"> <text>Responses to all required fields and applicable questions; and</text> </paragraph> <paragraph num="(ii)"> <text>Supporting documentation related to residency, medical, and financial eligibility criteria.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An applicant may voluntarily withdraw the application at any time without prejudice.</text> </paragraph> <paragraph num="(c)"> <text>An applicant may submit a new application at any time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Approve the application if the:</text> <paragraph num="(i)"> <text>Application is complete; and</text> </paragraph> <paragraph num="(ii)"> <text>Applicant is determined to be eligible;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Disapprove the application if the:</text> <paragraph num="(i)"> <text>Application is incomplete;</text> </paragraph> <paragraph num="(ii)"> <text>Applicant fails to provide sufficient information or documentation to determine eligibility; or</text> </paragraph> <paragraph num="(iii)"> <text>Applicant provides the appropriate documentation but is determined ineligible; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide the applicant with written notice of the final disposition of the application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Enrollment.</text> <paragraph num="(1)"> <text>If the Department requests it, a recipient shall:</text> <paragraph num="(a)"> <text>Attest to continuing eligibility:</text> </paragraph> <paragraph num="(b)"> <text>Submit a completed verification of eligibility form; and</text> </paragraph> <paragraph num="(c)"> <text>Provide supporting documentation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A recipient’s MADAP benefits shall be suspended, effective at the end of the month following the month the verification of eligibility is due, if the recipient fails to attest to eligibility for MADAP.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Enroll an applicant who has been determined eligible with the stipulation that eligibility must be verified as requested by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Establish enrollment in MADAP beginning on the first day of the month in which the:</text> <paragraph num="(i)"> <text>Department approves the application; or</text> </paragraph> <paragraph num="(ii)"> <text>Recipient will need to access medications through MADAP;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Redetermine eligibility if the Department receives information that may affect eligibility; and</text> </paragraph> <paragraph num="(d)"> <text>Send any relevant verification of eligibility forms to the recipient at least 45 calendar days before the forms are due to be submitted to the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Changes in Eligibility and Disenrollment."> <paragraph num="A."> <text>A recipient shall notify the Department within 10 business days of a change in:</text> <paragraph num="(1)"> <text>Availability of third-party payment for services covered under MADAP;</text> </paragraph> <paragraph num="(2)"> <text>Gross household income; or</text> </paragraph> <paragraph num="(3)"> <text>Address.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP, the Department shall:</text> <paragraph num="(1)"> <text>Determine the recipient ineligible for MADAP; and</text> </paragraph> <paragraph num="(2)"> <text>Disenroll the recipient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice of intended action, which notifies the recipient of the disenrollment, shall:</text> <paragraph num="(1)"> <text>Be mailed to the recipient at least 15 business days before the effective date of disenrollment;</text> </paragraph> <paragraph num="(2)"> <text>Include an explanation of the action;</text> </paragraph> <paragraph num="(3)"> <text>Cite the regulation supporting the action; and</text> </paragraph> <paragraph num="(4)"> <text>Explain the right of the recipient to request reconsideration or an appeal of the decision.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the recipient is determined to be ineligible before the next verification of eligibility is due to be submitted to the Department because of a change in eligibility, the disenrollment shall be the earlier of:</text> <paragraph num="(1)"> <text>The date on which the recipient’s next verification of eligibility is due to be submitted to the Department; or</text> </paragraph> <paragraph num="(2)"> <text>The first day of the month that is at least 15 calendar days after the date of the notice of ineligibility for MADAP benefits.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the recipient’s Medical Assistance coverage is pending or active, the recipient shall be disenrolled, as determined by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reconsideration and Appeal."> <paragraph num="A."> <text>An applicant or recipient who has been notified by the Department of ineligibility for or disenrollment from MADAP benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification.</text> </paragraph> <paragraph num="B."> <text>If an applicant or recipient submits a timely request for reconsideration, the Department shall:</text> <paragraph num="(1)"> <text>Review all additional supporting documentation, within 5 business days of the Department’s receipt of the request for reconsideration; and</text> </paragraph> <paragraph num="(2)"> <text>Issue a final decision in writing to the applicant or recipient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department.</text> </paragraph> <paragraph num="D."> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Conduct a hearing according to the procedures set forth in COMAR 28.02.01;</text> </paragraph> <paragraph num="(2)"> <text>Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and</text> </paragraph> <paragraph num="(3)"> <text>Issue a decision in writing to the applicant or recipient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Recovery of Payments."> <text>If MADAP benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Fraud."> <text>The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Confidentiality."> <text>Unless otherwise authorized by law, the Department:</text> <paragraph num="A."> <text>Shall keep all applicant and recipient personal information confidential;</text> </paragraph> <paragraph num="B."> <text>May not disclose personal information kept on an applicant or recipient without written consent of the:</text> <paragraph num="(1)"> <text>Applicant;</text> </paragraph> <paragraph num="(2)"> <text>Recipient;</text> </paragraph> <paragraph num="(3)"> <text>Applicant’s parent or legal guardian; or</text> </paragraph> <paragraph num="(4)"> <text>Recipient’s parent or legal guardian;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall comply with the laws and regulations concerning the privacy and security of protected health information under:</text> <paragraph num="(1)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Availability of Funding and Program Termination."> <paragraph num="A."> <text>If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination.</text> </paragraph> <paragraph num="B."> <text>If MADAP is terminated the Department shall provide benefits for each current recipient until the earlier of:</text> <paragraph num="(1)"> <text>The date on which the next verification of eligibility is due to be submitted to the Department; or</text> </paragraph> <paragraph num="(2)"> <text>Six months from the date MADAP is terminated.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.15 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); repealed permanently effective May 26, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C adopted effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488); October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D, E amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="06" heading="Maryland AIDS Drug Assistance Program: Pharmacy Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.</text> </paragraph> <paragraph num="(5)"> <text>“Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.</text> </paragraph> <paragraph num="(6)"> <text>“Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS.</text> </paragraph> <paragraph num="(7)"> <text>“Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in Regulation .04 of this chapter for enrolled recipients.</text> </paragraph> <paragraph num="(8)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(9)"> <text>“Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter.</text> </paragraph> <paragraph num="(10)"> <text>“Pharmacist” means an individual registered and licensed to practice pharmacy in the state where the prescription is filled.</text> </paragraph> <paragraph num="(11)"> <text>“Pharmacy” means an establishment or institution registered and licensed to dispense U.S. Food and Drug Administration-approved drugs or other products to the public in the state in which the establishment or institution is located.</text> </paragraph> <paragraph num="(12)"> <text>“Preauthorization” means an approval required before the dispensing of the prescription.</text> </paragraph> <paragraph num="(13)"> <text>“Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product not excluded from the open formulary.</text> </paragraph> <paragraph num="(14)"> <text>“Recipient” means an individual who is enrolled in MADAP.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Permit and License Requirements."> <paragraph num="A."> <text>To qualify for participation in MADAP, a pharmacy shall first obtain a permit from:</text> <paragraph num="(1)"> <text>The State Board of Pharmacy, pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>The appropriate agency in the state in which the pharmacy is located.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.</text> </paragraph> <paragraph num="C."> <text>To qualify for participation in MADAP, a health care practitioner shall be:</text> <paragraph num="(1)"> <text>Licensed; and</text> </paragraph> <paragraph num="(2)"> <text>Legally authorized to practice medicine in accordance with applicable state and federal laws.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Participation."> <paragraph num="A."> <text>To participate in MADAP, a pharmacy shall:</text> <paragraph num="(1)"> <text>Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department;</text> </paragraph> <paragraph num="(2)"> <text>Accept payment by the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family;</text> </paragraph> <paragraph num="(3)"> <text>Maintain records in accordance with standards established by Medical Assistance;</text> </paragraph> <paragraph num="(4)"> <text>Maintain prescriptions for a minimum of 5 years and make them available for inspection, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="(5)"> <text>Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and</text> </paragraph> <paragraph num="(6)"> <text>Bill the recipient’s third-party insurance payer in accordance with the payer’s requirements in order to reduce the cost to be paid by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy may not:</text> <paragraph num="(1)"> <text>Knowingly employ a person who has been disqualified from Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>Place a restriction on a recipient’s right to select a pharmacy of the recipient’s choice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The recipient shall obtain a prescription for each drug or other product ordered for the recipient.</text> </paragraph> <paragraph num="B."> <text>The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for the recipient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Formulary."> <text>The Department shall:</text> <paragraph num="A."> <text>Maintain a list of drugs and other products excluded from the open formulary; and</text> </paragraph> <paragraph num="B."> <text>Make available electronically the list of drugs and other products excluded from the open formulary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitations on Covered Services."> <paragraph num="A."> <text>A pharmacist may not dispense more than a 100-day supply of a prescribed drug or other product.</text> </paragraph> <paragraph num="B."> <text>The Department may not pay for:</text> <paragraph num="(1)"> <text>A drug or other product prescribed as part of a recipient’s care in a correctional institution, inpatient hospital, nursing home, or long-term care setting; or</text> </paragraph> <paragraph num="(2)"> <text>Drugs or other products excluded from the open formulary, unless the Department grants the recipient preauthorization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preauthorization Requirement."> <text>A pharmacist shall obtain preauthorization for each prescription or refill before dispensing a drug or other product marked as restricted.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>Except as provided in §§B and C of this regulation, the Department shall pay a pharmacy in accordance with the procedures of the Medical Assistance Pharmacy Services Program set forth at COMAR 10.09.03.07.</text> </paragraph> <paragraph num="B."> <text>If the Department or the recipient tells the pharmacy that the recipient has or may have third-party insurance coverage to offset some or all of the cost for services provided under MADAP, the pharmacy shall:</text> <paragraph num="(1)"> <text>Bill the third-party payer the pharmacy’s usual and customary charge for the services provided; and</text> </paragraph> <paragraph num="(2)"> <text>Bill the Department for the difference between the pharmacy’s usual and customary charge and the anticipated third-party receipts.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the recipient has third-party insurance coverage, the Department shall pay the pharmacy the difference between the pharmacy’s usual and customary charge and the anticipated third-party insurance receipts, not to exceed the amount permitted under COMAR 10.09.03.07F and G.</text> </paragraph> <paragraph num="D."> <text>The Department shall make payments related to MADAP in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009, and any subsequent modifications to the Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <text>The Department shall follow the same procedures for recovery and reimbursement as the Medical Assistance Program in COMAR 10.09.03.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions."> <paragraph num="A."> <text>If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may:</text> <paragraph num="(1)"> <text>Suspend the pharmacy from MADAP;</text> </paragraph> <paragraph num="(2)"> <text>Withhold payment to the pharmacy; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Removal of a pharmacy or a pharmacy’s employee from Medical Assistance shall result in removal from MADAP.</text> </paragraph> <paragraph num="C."> <text>The Department:</text> <paragraph num="(1)"> <text>May consult with the State Board of Pharmacy regarding the actions of a pharmacy, such as:</text> <paragraph num="(a)"> <text>A breach of confidentiality;</text> </paragraph> <paragraph num="(b)"> <text>Refusal of service; or</text> </paragraph> <paragraph num="(c)"> <text>Discrimination; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall consider the findings and recommendations of the State Board of Pharmacy when deciding on the imposition of a sanction as stated in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall give the pharmacy written notice of the Department’s intention to impose sanctions referred to in §A of this regulation, including:</text> <paragraph num="(1)"> <text>The effective date of the proposed action;</text> </paragraph> <paragraph num="(2)"> <text>The reason for the proposed action; and</text> </paragraph> <paragraph num="(3)"> <text>The pharmacy’s right to appeal the proposed action.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A pharmacy voluntarily withdrawing from MADAP or removed or suspended from MADAP according to this regulation shall notify a recipient that the pharmacy is no longer a MADAP pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Appeal Procedures."> <text>A pharmacy filing an appeal shall do so in accordance with the Medical Assistance Program as set forth at COMAR 10.09.03.10.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Confidentiality."> <text>Unless otherwise authorized by law, the Department:</text> <paragraph num="A."> <text>Shall keep all applicant and recipient personal information confidential;</text> </paragraph> <paragraph num="B."> <text>May not disclose personal information kept on a recipient without written consent of the:</text> <paragraph num="(1)"> <text>Recipient; or</text> </paragraph> <paragraph num="(2)"> <text>Recipient’s parent or legal guardian;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall comply with the laws and regulations concerning the privacy and security of protected health information under:</text> <paragraph num="(1)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Availability of Funding and Program Termination."> <paragraph num="A."> <text>If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination.</text> </paragraph> <paragraph num="B."> <text>If MADAP is terminated, the Department shall provide benefits for each current recipient in accordance with COMAR 10.18.05.09B.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 amended effective September 15, 2014 (41:18 Md. R. 1010)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective February 20, 2007 (34:7 Md. R. 694); amended permanently effective June 18, 2007 (34:12 Md. R. 1067)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 19, 2026 (53:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 repealed effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488), October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 14, 2024 (51:20 Md. R. 899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="07" heading="Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS)"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program—Plus and whose eligibility status for the Maryland AIDS Drug Assistance Program—Plus has not yet determined.</text> </paragraph> <paragraph num="(3)"> <text>“Core medical services” means a set of direct health care services as specified by the Ryan White Care Act Part B Program administered by the U.S. Health Resource and Services Administration.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.</text> </paragraph> <paragraph num="(6)"> <text>“Health care provider” means an individual licensed to provide core medical services in the state where services are rendered.</text> </paragraph> <paragraph num="(7)"> <text>“Human immunodeficiency virus (HIV)” means the virus that causes AIDS.</text> </paragraph> <paragraph num="(8)"> <text>“Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.</text> </paragraph> <paragraph num="(9)"> <text>“Maryland AIDS Drug Assistance Program—Plus (MADAP-Plus)” means the program administered by the Department to pay insurance premiums, copays, coinsurance, and deductibles for drugs and core medical services.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(11)"> <text>“Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.</text> </paragraph> <paragraph num="(12)"> <text>“Recipient” means an individual who is enrolled in MADAP-Plus.</text> </paragraph> <paragraph num="(13)"> <text>“Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to COMAR 10.18.05.03B(1)(a).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility."> <paragraph num="A."> <text>To be eligible for MADAP-Plus coverage, an individual shall be:</text> <paragraph num="(1)"> <text>Enrolled in MADAP; and</text> </paragraph> <paragraph num="(2)"> <text>Receiving or eligible to receive health insurance and prescription drug coverage.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual who is eligible for employer-sponsored health insurance with a prescription drug formulary that includes antiretroviral medications may not receive premium assistance unless the individual is:</text> <paragraph num="(1)"> <text>Enrolled in the employer-sponsored health plan; and</text> </paragraph> <paragraph num="(2)"> <text>Paying 50 percent or more of the total monthly health insurance premiums.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application and Enrollment."> <paragraph num="A."> <text>An applicant shall apply in the manner set forth in COMAR 10.18.05.03A.</text> </paragraph> <paragraph num="B."> <text>A recipient and the Department shall meet the enrollment responsibilities set forth in COMAR 10.18.05.03B.</text> </paragraph> <paragraph num="C."> <text>The duration of the recipient’s enrollment in MADAP-Plus may not extend beyond the duration of the recipient’s enrollment in MADAP.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Covered Services."> <paragraph num="A."> <text>The Department shall pay for health and prescription plan premiums with a prescription drug formulary that includes antiretroviral medications.</text> </paragraph> <paragraph num="B."> <text>Within the limits established by the Department and in accordance with policy guidance issued by the Health Resources and Services Administration, the Department:</text> <paragraph num="(1)"> <text>Shall pay for copays, coinsurance, and deductibles for drugs; and</text> </paragraph> <paragraph num="(2)"> <text>May pay for copays, coinsurance, and deductibles associated with core medical services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Changes in Eligibility and Disenrollment."> <paragraph num="A."> <text>A recipient shall inform the Department of a change in eligibility as set forth in COMAR 10.18.05.04A.</text> </paragraph> <paragraph num="B."> <text>If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP-Plus, the Department shall:</text> <paragraph num="(1)"> <text>Determine the recipient ineligible for MADAP-Plus; and</text> </paragraph> <paragraph num="(2)"> <text>Disenroll the recipient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a MADAP-Plus recipient is disenrolled from MADAP, the recipient is automatically disenrolled from MADAP-Plus.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reconsideration and Appeal."> <paragraph num="A."> <text>An applicant or recipient who has been notified by the Department of disenrollment or ineligibility for MADAP-Plus benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification.</text> </paragraph> <paragraph num="B."> <text>If an applicant or recipient submits a timely request for reconsideration, the Department shall:</text> <paragraph num="(1)"> <text>Review all additional supporting documentation, within five business days of the Department’s receipt of the request for reconsideration; and</text> </paragraph> <paragraph num="(2)"> <text>Issue a final decision in writing to the applicant or recipient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department.</text> </paragraph> <paragraph num="D."> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Conduct a hearing according to the procedures set forth in COMAR 28.02.01;</text> </paragraph> <paragraph num="(2)"> <text>Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and</text> </paragraph> <paragraph num="(3)"> <text>Issue a decision in writing to the applicant or recipient.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall pay any health insurance plan or prescription drug plan costs due pending a decision by the Office of Administrative Hearings.</text> </paragraph> <paragraph num="F."> <text>If the final decision finds in favor of the Department, the Department shall, upon the date of the decision, cease paying the health insurance costs allowed under this chapter and seek recovery in accordance with Regulation .08 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>A recipient, recipient’s representative, health care provider, insurer, employer, or health plan administrator, as applicable:</text> <paragraph num="(1)"> <text>May request payment costs allowed under this chapter on behalf of the recipient according to procedures established by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Shall submit a payment request that is:</text> <paragraph num="(a)"> <text>An invoice for the recipient’s health or prescription drug plan insurance premium, copays, coinsurance, and deductibles for core medical services issued by an insurer, an employer, a health plan administrator, prescription drug plan administrator, or a health care provider; and</text> </paragraph> <paragraph num="(b)"> <text>Submitted timely to allow for payment in accordance with §§A(3) and B(4) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Shall make the initial request for the payment of costs within the time frames established by the health or prescription drug insurance policy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department:</text> <paragraph num="(1)"> <text>Shall process a payment request as required by this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall inform a recipient or the recipient’s representative if an invoice is not paid;</text> </paragraph> <paragraph num="(3)"> <text>Shall make payments in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White CARE Act Amendments of 1996, P. L. 104—146, and any subsequent modifications to the Act; and</text> </paragraph> <paragraph num="(4)"> <text>Shall make subsequent payments:</text> <paragraph num="(a)"> <text>As permitted under a health or prescription drug plan; or</text> </paragraph> <paragraph num="(b)"> <text>Upon agreement between the Department and the:</text> <paragraph num="(i)"> <text>Insurer;</text> </paragraph> <paragraph num="(ii)"> <text>Employer;</text> </paragraph> <paragraph num="(iii)"> <text>Health plan administrator;</text> </paragraph> <paragraph num="(iv)"> <text>Prescription drug plan administrator; or</text> </paragraph> <paragraph num="(v)"> <text>Health care provider.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery of Payments."> <text>If MADAP-Plus payments have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Fraud."> <text>The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Confidentiality."> <text>Unless otherwise authorized by law, the Department:</text> <paragraph num="A."> <text>Shall keep all applicant and recipient personal information confidential;</text> </paragraph> <paragraph num="B."> <text>May not disclose personal information kept on an applicant or recipient without the written consent of the:</text> <paragraph num="(1)"> <text>Applicant;</text> </paragraph> <paragraph num="(2)"> <text>Recipient;</text> </paragraph> <paragraph num="(3)"> <text>Applicant’s parent or legal guardian; or</text> </paragraph> <paragraph num="(4)"> <text>Recipient’s parent or legal guardian;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall comply with the laws and regulations concerning the privacy and security of protected health information under:</text> <paragraph num="(1)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C; §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Availability of Funding and Program Termination."> <paragraph num="A."> <text>If sufficient monies are not available to fund MADAP-Plus, the Department shall take the action necessary to eliminate a deficit which may include MADAP-Plus termination.</text> </paragraph> <paragraph num="B."> <text>If MADAP-Plus is terminated, the Department shall provide coverage for each current recipient until the earlier of:</text> <paragraph num="(1)"> <text>The date on which the next verification of eligibility is due to be submitted to the Department; or</text> </paragraph> <paragraph num="(2)"> <text>Six months from the date MADAP-Plus is terminated.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and(i) and 2-105(a) and (b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 3, 2003 (30:2 Md. R. 76)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, E amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="08" heading="HIV Testing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>Except as provided in §§C—F of this regulation, this chapter governs:</text> <paragraph num="(1)"> <text>Pretest and post-test information;</text> </paragraph> <paragraph num="(2)"> <text>Requirements for reporting and control efforts;</text> </paragraph> <paragraph num="(3)"> <text>Requirements for informed consent; and</text> </paragraph> <paragraph num="(4)"> <text>Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In cases exempt from the requirements for consent throughout this chapter, as specified in §§C—F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary.</text> </paragraph> <paragraph num="C."> <text>If an HIV test is performed on an individual solely for the purpose of determining the suitability of that individual as a prospective donor of blood, semen, or tissue, the requirements for information and consent are addressed in:</text> <paragraph num="(1)"> <text>Health-General Article, §18-334, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.50.01.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If an HIV test is performed on an individual as a result of a court order issued under the provisions of the Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>The requirements for HIV testing are addressed in COMAR 10.52.10; and</text> </paragraph> <paragraph num="(2)"> <text>Informed consent does not apply.</text> </paragraph> </paragraph> <paragraph num="E."> <text>HIV testing undertaken under provisions of Health-General Article, §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter.</text> </paragraph> <paragraph num="F."> <text>HIV testing of specimens for research is not governed by this chapter if:</text> <paragraph num="(1)"> <text>All personal identifiers have been removed from the specimen;</text> </paragraph> <paragraph num="(2)"> <text>The specimen cannot be linked to the patient from whom the specimen was taken;</text> </paragraph> <paragraph num="(3)"> <text>The test result cannot be linked to the patient from whom the specimen was taken; and</text> </paragraph> <paragraph num="(4)"> <text>The research protocol has been approved by an institutional review board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>This chapter pertains to all patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.</text> </paragraph> <paragraph num="(2)"> <text>“Anonymous” means that:</text> <paragraph num="(a)"> <text>A patient’s name is not used for identification; and</text> </paragraph> <paragraph num="(b)"> <text>The patient can be identified only through use of an assigned code.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Applicant” means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site.</text> </paragraph> <paragraph num="(4)"> <text>“Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>“Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services.</text> </paragraph> <paragraph num="(6)"> <text>“Confidential” means that a patient’s name is used as identification and that the patient’s medical records contain the patient’s name but are protected against disclosure as provided by statute.</text> </paragraph> <paragraph num="(7)"> <text>“Counseling” means providing education to pregnant women on:</text> <paragraph num="(a)"> <text>The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and</text> </paragraph> <paragraph num="(b)"> <text>Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Designated anonymous testing site” means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification.</text> </paragraph> <paragraph num="(10)"> <text>“Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider including:</text> <paragraph num="(a)"> <text>A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>The Department of Public Safety and Correctional Services;</text> </paragraph> <paragraph num="(e)"> <text>A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>A facility operated by the Department or a local health officer; or</text> </paragraph> <paragraph num="(g)"> <text>The office of a health care provider.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Health care provider” means a:</text> <paragraph num="(a)"> <text>Physician;</text> </paragraph> <paragraph num="(b)"> <text>Nurse;</text> </paragraph> <paragraph num="(c)"> <text>Licensed direct-entry midwife; or</text> </paragraph> <paragraph num="(d)"> <text>Designee of a health care facility.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Human immunodeficiency virus (HIV)” means a virus that causes AIDS.</text> </paragraph> <paragraph num="(13)"> <text>“Indeterminate HIV test result” means that a test did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria.</text> </paragraph> <paragraph num="(14)"> <text>“Informed consent” means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter.</text> </paragraph> <paragraph num="(15)"> <text>“Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research.</text> </paragraph> <paragraph num="(16)"> <text>“Negative HIV test result” means the test result failed to document the presence of HIV as defined by the CDC’s laboratory criteria.</text> </paragraph> <paragraph num="(17)"> <text>Nonclinical Settings.</text> <paragraph num="(a)"> <text>“Nonclinical settings” means locations:</text> <paragraph num="(i)"> <text>That are not health care settings;</text> </paragraph> <paragraph num="(ii)"> <text>Where medical or treatment services are not provided; and</text> </paragraph> <paragraph num="(iii)"> <text>Where selected diagnostic services and selected prevention services may be provided.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Nonclinical settings” may include:</text> <paragraph num="(i)"> <text>Community based organizations;</text> </paragraph> <paragraph num="(ii)"> <text>Outreach settings; or</text> </paragraph> <paragraph num="(iii)"> <text>Mobile vans.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>Partner.</text> <paragraph num="(a)"> <text>“Partner” means an individual with whom one has:</text> <paragraph num="(i)"> <text>Had or will have, oral, anal, or vaginal sexual contact; or</text> </paragraph> <paragraph num="(ii)"> <text>Shared hypodermic needles or other similar drug paraphernalia.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Partner” includes any individual who:</text> <paragraph num="(i)"> <text>Is the marriage partner of an HIV-infected patient; or</text> </paragraph> <paragraph num="(ii)"> <text>Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV.</text> </paragraph> <paragraph num="(20)"> <text>“Positive HIV test result” means the test result has documented the presence of HIV as defined by the CDC’s laboratory criteria.</text> </paragraph> <paragraph num="(21)"> <text>“Post-test information” means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter.</text> </paragraph> <paragraph num="(22)"> <text>“Prenatal care” means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include:</text> <paragraph num="(a)"> <text>Screening;</text> </paragraph> <paragraph num="(b)"> <text>Physical examination;</text> </paragraph> <paragraph num="(c)"> <text>Laboratory and diagnostic testing procedures and interpretation; or</text> </paragraph> <paragraph num="(d)"> <text>Counseling.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Pretest information” means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .08 of this chapter.</text> </paragraph> <paragraph num="(24)"> <text>“Research” means an investigation carried out according to a protocol approved by an institutional review board.</text> </paragraph> <paragraph num="(25)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(26)"> <text>“Seropositive” means that a positive HIV test result has been obtained from the test of a patient’s specimen.</text> </paragraph> <paragraph num="(27)"> <text>“Specimen” means a sample of:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Other body fluid; or</text> </paragraph> <paragraph num="(c)"> <text>Body tissue.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Designated Anonymous Testing Sites."> <paragraph num="A."> <text>An applicant shall seek approval from an appropriate entity to become a designated anonymous testing site from the:</text> <paragraph num="(1)"> <text>Baltimore City Health Department for an applicant offering services in Baltimore City; or</text> </paragraph> <paragraph num="(2)"> <text>Department for an applicant offering services outside of Baltimore City.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant that seeks approval to become a designated anonymous testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity.</text> </paragraph> <paragraph num="C."> <text>The Department or the Baltimore City Health Department shall:</text> <paragraph num="(1)"> <text>Review a written request that is submitted for approval; and</text> </paragraph> <paragraph num="(2)"> <text>Respond in writing to the written request:</text> <paragraph num="(a)"> <text>Indicating approval or disapproval to become a designated anonymous testing site; or</text> </paragraph> <paragraph num="(b)"> <text>Soliciting for revision and resubmission of the written request.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Designated Confidential Testing Sites."> <paragraph num="A."> <text>An applicant shall seek approval from an appropriate entity to become a designated confidential testing site from the:</text> <paragraph num="(1)"> <text>Baltimore City Health Department for an applicant offering services in Baltimore City; or</text> </paragraph> <paragraph num="(2)"> <text>Department for an applicant offering services outside of Baltimore City.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant that seeks approval to become a designated confidential testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity.</text> </paragraph> <paragraph num="C."> <text>The Department or the Baltimore City Health Department shall:</text> <paragraph num="(1)"> <text>Review a written request that is submitted for approval; and</text> </paragraph> <paragraph num="(2)"> <text>Respond in writing to the written request:</text> <paragraph num="(a)"> <text>Indicating approval or disapproval to become a designated confidential testing site; or</text> </paragraph> <paragraph num="(b)"> <text>Soliciting for revision and resubmission of the written request.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial and Reconsideration."> <paragraph num="A."> <text>An applicant under Regulation .03 or .04 of this chapter that has a written request denied by the appropriate entity may request reconsideration of the decision:</text> <paragraph num="(1)"> <text>By submitting the request in writing to the appropriate entity; and</text> </paragraph> <paragraph num="(2)"> <text>Within 30 calendar days of the date on the notice of denial.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an applicant requests a reconsideration according to §A of this regulation, the appropriate entity shall:</text> <paragraph num="(1)"> <text>Review the request for reconsideration and any supplemental documentation submitted by the applicant within 45 calendar days of the date on the letter requesting reconsideration; and</text> </paragraph> <paragraph num="(2)"> <text>Issue a decision in writing to the applicant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Consent and Pretest Requirements for HIV Testing by Health Care Providers."> <paragraph num="A."> <text>General medical consent is sufficient to perform HIV testing.</text> </paragraph> <paragraph num="B."> <text>Consent for HIV testing is only required to be obtained one time during a patient’s visit.</text> </paragraph> <paragraph num="C."> <text>A health care provider who obtains consent for HIV testing shall:</text> <paragraph num="(1)"> <text>Obtain consent as a part of a patient’s general consent for medical care in the same manner as for other screening and diagnostic tests;</text> </paragraph> <paragraph num="(2)"> <text>Document all declinations of an HIV test in the medical record of the patient; and</text> </paragraph> <paragraph num="(3)"> <text>When needed, obtain:</text> <paragraph num="(a)"> <text>Consent from a health care agent designated per Health-General Article, §5-602, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Surrogate consent per Health-General Article, §5-605 Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The general informed consent form for medical care may specify that an HIV test will be performed.</text> </paragraph> <paragraph num="E."> <text>Except as provided under Regulation .08 of this chapter, a health care provider may not be required to obtain consent for HIV testing on a separate consent form.</text> </paragraph> <paragraph num="F."> <text>Pretest information, including counseling for pregnant women, shall be provided to the patient to be tested for HIV before each specimen is tested.</text> </paragraph> <paragraph num="G."> <text>A health care provider providing pretest information, including counseling for pregnant women, shall:</text> <paragraph num="(1)"> <text>Provide HIV-specific information:</text> <paragraph num="(a)"> <text>Verbally;</text> </paragraph> <paragraph num="(b)"> <text>In writing;</text> </paragraph> <paragraph num="(c)"> <text>Through video; or</text> </paragraph> <paragraph num="(d)"> <text>Through any combination of §G(1)(a)—(c) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide HIV information in a manner that protects the confidentiality of the patient being tested;</text> </paragraph> <paragraph num="(3)"> <text>Using layman’s terms, provide, at minimum, the following information to the patient being tested:</text> <paragraph num="(a)"> <text>That the patient is being tested for HIV;</text> </paragraph> <paragraph num="(b)"> <text>That the patient has the right to:</text> <paragraph num="(i)"> <text>Ask questions; and</text> </paragraph> <paragraph num="(ii)"> <text>Decline the test without penalty;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An explanation of HIV infection;</text> </paragraph> <paragraph num="(d)"> <text>That a negative HIV test result means that:</text> <paragraph num="(i)"> <text>A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and</text> </paragraph> <paragraph num="(ii)"> <text>If the patient has had any potential recent exposures, the patient should be retested within an appropriate time frame based on the type of testing used; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>That a positive HIV test result means the patient:</text> <paragraph num="(i)"> <text>Is infected with HIV; and</text> </paragraph> <paragraph num="(ii)"> <text>Will be linked with medical treatment and other supportive services;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide counseling as defined in Regulation .02 of this chapter to pregnant women;</text> </paragraph> <paragraph num="(5)"> <text>Include an opportunity for the patient to:</text> <paragraph num="(a)"> <text>Ask questions and receive answers about HIV and other topics described in this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Decline an HIV test; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Make necessary accommodation with respect to language or disability to ensure that the patient being tested understands the information presented.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Testing Requirements for Pregnant Women Receiving Prenatal Care."> <paragraph num="A."> <text>As part of a health care provider’s patient acceptance procedures or protocol, a health care provider shall give a pregnant woman information on being tested for the presence of HIV as part of the woman’s prenatal care program.</text> </paragraph> <paragraph num="B."> <text>In addition to §§C—E of this regulation, a health care provider testing a pregnant woman shall follow all requirements for pretest and post-test information as set forth in Regulations .06 and .08—.10 of this chapter as appropriate.</text> </paragraph> <paragraph num="C."> <text>Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care:</text> <paragraph num="(1)"> <text>During the first trimester of pregnancy or the first prenatal visit; and</text> </paragraph> <paragraph num="(2)"> <text>In the third trimester of pregnancy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A health care provider who provides labor and delivery services to a pregnant woman shall offer:</text> <paragraph num="(1)"> <text>A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and</text> </paragraph> <paragraph num="(2)"> <text>Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Confidentiality.</text> <paragraph num="(1)"> <text>HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Except as otherwise provided in §E(3) of this regulation, the record of an HIV test performed under this section is confidential and not discoverable or admissible in evidence in any criminal, civil, or administrative action.</text> </paragraph> <paragraph num="(3)"> <text>Provided that the identity or any other information that could readily be associated with the identity of the pregnant woman is not disclosed, the results of an HIV test performed under this section may be introduced into evidence in a criminal, civil, or administrative action, including the adjudication of a workers’ compensation claim.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Consent and Pretest Requirements for HIV Testing in Nonclinical Settings."> <paragraph num="A."> <text>For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall:</text> <paragraph num="(1)"> <text>Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent;</text> </paragraph> <paragraph num="(2)"> <text>Read and explain the HIV informed consent form, through an interpreter if necessary, to anyone who cannot read or understand the form’s contents; and</text> </paragraph> <paragraph num="(3)"> <text>Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent.</text> </paragraph> <paragraph num="C."> <text>Pretest information shall be provided to the patient being tested before each specimen is tested.</text> </paragraph> <paragraph num="D."> <text>An individual providing pretest information shall:</text> <paragraph num="(1)"> <text>Provide HIV-specific information:</text> <paragraph num="(a)"> <text>Verbally;</text> </paragraph> <paragraph num="(b)"> <text>In writing;</text> </paragraph> <paragraph num="(c)"> <text>Through video; or</text> </paragraph> <paragraph num="(d)"> <text>Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the patient;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide HIV information in a manner that protects the confidentiality of the patient;</text> </paragraph> <paragraph num="(3)"> <text>Using layman’s terms, provide, at a minimum, the following information to the patient:</text> <paragraph num="(a)"> <text>That the patient is being tested for HIV;</text> </paragraph> <paragraph num="(b)"> <text>That the patient has the right to:</text> <paragraph num="(i)"> <text>Ask questions; and</text> </paragraph> <paragraph num="(ii)"> <text>Decline the test without penalty;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The primary modes of HIV transmission including:</text> <paragraph num="(i)"> <text>Sexual contact without the use of condoms, other barriers, or other biomedical interventions;</text> </paragraph> <paragraph num="(ii)"> <text>Injection drug use; and</text> </paragraph> <paragraph num="(iii)"> <text>Mother-to-child transmission;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Counseling as defined in Regulation .02 of this chapter to pregnant women;</text> </paragraph> <paragraph num="(e)"> <text>That a negative test result means that:</text> <paragraph num="(i)"> <text>A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and</text> </paragraph> <paragraph num="(ii)"> <text>If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>That a positive test result means the patient:</text> <paragraph num="(i)"> <text>Is infected with HIV;</text> </paragraph> <paragraph num="(ii)"> <text>Will be linked with medical treatment and other supportive services; and</text> </paragraph> <paragraph num="(iii)"> <text>May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Include an opportunity for the patient to:</text> <paragraph num="(a)"> <text>Ask questions and receive answers about HIV infection and other topics described in this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Decline HIV testing; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Post-Test Requirements for HIV Testing by Health Care Providers."> <paragraph num="A."> <text>If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:</text> <paragraph num="(1)"> <text>That the HIV test result is negative; and</text> </paragraph> <paragraph num="(2)"> <text>The meaning of a negative result.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient in person that includes:</text> <paragraph num="(1)"> <text>That the HIV test result is indeterminate;</text> </paragraph> <paragraph num="(2)"> <text>The meaning of an indeterminate HIV test result; and</text> </paragraph> <paragraph num="(3)"> <text>A recommendation that the patient:</text> <paragraph num="(a)"> <text>Return in a medically appropriate time frame for another HIV test; and</text> </paragraph> <paragraph num="(b)"> <text>Take precautions as if the patient’s HIV test result had been positive until the patient is retested.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a patient’s HIV test result is positive:</text> <paragraph num="(1)"> <text>The individual providing testing shall provide post-test information to the patient in person that includes:</text> <paragraph num="(a)"> <text>That the HIV test result is positive;</text> </paragraph> <paragraph num="(b)"> <text>The meaning of a positive HIV test result;</text> </paragraph> <paragraph num="(c)"> <text>If the patient is pregnant:</text> <paragraph num="(i)"> <text>How HIV infection may affect a pregnancy, fetus, or newborn;</text> </paragraph> <paragraph num="(ii)"> <text>That there is a potential that the newborn will have HIV infection; and</text> </paragraph> <paragraph num="(iii)"> <text>Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Information regarding the patient’s responsibility to:</text> <paragraph num="(i)"> <text>Notify all known sexual and needle-sharing partners of possible exposure; or</text> </paragraph> <paragraph num="(ii)"> <text>Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The health care provider shall:</text> <paragraph num="(a)"> <text>Ensure the patient is linked to an appropriate source of HIV medical care and support services; and</text> </paragraph> <paragraph num="(b)"> <text>If necessary, provide the patient with information about mental health services for HIV-infected individuals;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For contact control, the health care provider shall:</text> <paragraph num="(a)"> <text>Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by:</text> <paragraph num="(i)"> <text>Requesting the health officer to conduct a contact investigation of any case of HIV; or</text> </paragraph> <paragraph num="(ii)"> <text>Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and</text> </paragraph> <paragraph num="(b)"> <text>Immediately forward to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Post-Test Requirements for HIV Testing in Nonclinical Settings."> <paragraph num="A."> <text>If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:</text> <paragraph num="(1)"> <text>That the HIV test result is negative;</text> </paragraph> <paragraph num="(2)"> <text>The meaning of a negative result; and</text> </paragraph> <paragraph num="(3)"> <text>A recommendation about whether a repeat test is advisable based on potential recent exposures and the type of test technology used.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient tested in person that includes:</text> <paragraph num="(1)"> <text>That the HIV test result is indeterminate;</text> </paragraph> <paragraph num="(2)"> <text>The meaning of an indeterminate HIV test result;</text> </paragraph> <paragraph num="(3)"> <text>Information regarding transmission of HIV and means of preventing transmission of HIV; and</text> </paragraph> <paragraph num="(4)"> <text>A recommendation that the patient:</text> <paragraph num="(a)"> <text>Return in a medically appropriate time frame for another HIV test; and</text> </paragraph> <paragraph num="(b)"> <text>Take precautions as if the patient’s HIV test result had been positive until the patient is retested.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a patient’s HIV test result is positive:</text> <paragraph num="(1)"> <text>The individual providing testing shall provide post-test information to the patient tested in person that includes:</text> <paragraph num="(a)"> <text>That the HIV test result is positive;</text> </paragraph> <paragraph num="(b)"> <text>The meaning of a positive HIV test result;</text> </paragraph> <paragraph num="(c)"> <text>Information regarding transmission of HIV and means of preventing transmission of HIV;</text> </paragraph> <paragraph num="(d)"> <text>If the patient is pregnant;</text> <paragraph num="(i)"> <text>How HIV infection may affect a pregnancy, fetus, or newborn;</text> </paragraph> <paragraph num="(ii)"> <text>That there is a potential that the newborn would have HIV infection; and</text> </paragraph> <paragraph num="(iii)"> <text>Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>That the patient should have a medical evaluation by a physician or physician’s designee who knows that the patient is HIV positive;</text> </paragraph> <paragraph num="(f)"> <text>That the patient should receive ongoing health care appropriate for an HIV seropositive individual; and</text> </paragraph> <paragraph num="(g)"> <text>Information regarding the patient’s responsibility to:</text> <paragraph num="(i)"> <text>Notify all known sexual and needle-sharing partners of possible exposure; or</text> </paragraph> <paragraph num="(ii)"> <text>Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual performing the HIV test shall:</text> <paragraph num="(a)"> <text>Ensure the patient is linked to an appropriate source of HIV medical care and support services including evaluation and treatment for:</text> <paragraph num="(i)"> <text>Tuberculosis;</text> </paragraph> <paragraph num="(ii)"> <text>Hepatitis;</text> </paragraph> <paragraph num="(iii)"> <text>Pregnancy; and</text> </paragraph> <paragraph num="(iv)"> <text>Sexually transmitted infections; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If necessary, provide the patient with information about mental health services for HIV-infected individuals;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For contact control, the individual providing the testing shall:</text> <paragraph num="(a)"> <text>Request the health officer from the patient’s home jurisdiction conduct a contact investigation of any case of HIV; and</text> </paragraph> <paragraph num="(b)"> <text>Report immediately to the health officer from the patient’s home jurisdiction any known individual identified as having had potentially infectious contact with a patient with a positive HIV test result;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A health officer shall:</text> <paragraph num="(a)"> <text>Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and</text> </paragraph> <paragraph num="(b)"> <text>Immediately forward to the Secretary all reports of individuals who are outside the health officer’s jurisdiction for referral to the health officer of the proper jurisdiction; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Immunity for Health Care Providers Working with Pregnant Women."> <text>A health care provider may not be subject to disciplinary action by the professional licensing board that licenses the health care provider for following the requirements for prenatal HIV testing established by the Department.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Health Care Providers, First Responders, and Public Safety Workers — HIV Exposure."> <paragraph num="A."> <text>Definition.</text> <paragraph num="(1)"> <text>In this regulation, the following term has the meaning indicated.</text> </paragraph> <paragraph num="(2)"> <text>“Infection preventionist or employee health provider” means the designated infectious disease/communicable disease officer of a hospital.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A health care provider, first responder, or public safety worker involved in an exposure as defined in Health-General Article, §18-338.3, Annotated Code of Maryland, shall comply with the provisions of Health-General Article, §18-338.3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A hospital’s designated infection preventionist or employee health provider or its designee shall follow the requirements in Health-General Article, §18-338.3, Annotated Code of Maryland, if an exposure, as defined in Health-General Article, §18-338.3, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Occurs:</text> <paragraph num="(a)"> <text>In a hospital, between a patient and a health care provider; or</text> </paragraph> <paragraph num="(b)"> <text>Before admission of the patient to a hospital, between a patient and a:</text> <paragraph num="(i)"> <text>First responder; or</text> </paragraph> <paragraph num="(ii)"> <text>Public safety worker; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is such that, in accordance with the CDC’s recommendations, warrants recommending or offering chemoprophylaxis treatment for the health care provider, first responder, or public safety worker.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Information on Exposures."> <paragraph num="A."> <text>A hospital where an exposure occurred shall:</text> <paragraph num="(1)"> <text>Maintain a confidential record or incident report for an HIV test conducted under Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Adopt procedures for the confidential HIV testing of blood samples or other body fluids used or collected for purposes of Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Maintain a record of:</text> <paragraph num="(a)"> <text>An exposure as defined by Health-General Article, §18-338.3(a), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>A refusal to consent by a patient as described in the Health-General Article, §18-338.3(b)(2)(ii), Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide records as specified in §A(3)of this regulation or information from the records to the Department when and as requested by the Secretary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nothing in Regulation .12 of this chapter or this regulation shall be construed to exempt any individual or entity required to report infectious diseases from reporting the infectious diseases as required in Health-General Article, Title 18, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Criminal Procedure Article, §§11-107—11-117; Health-General Article, §§2-104(b) and(i), 2-105(a) and (b),18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-334, 18-336—18-338, 18-338.2, 18-338.3, and 20-102; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 3, 2003 (30:2 Md. R. 76)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 8, 2008 (35:18 Md. R. 1600); December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective September 8, 2008 (35:18 Md. R. 1600)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, C amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective June 11, 2012 (39:11 Md. R. 687)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective June 11, 2012 (39:11 Md. R. 687)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 7, 2018 (45:9 Md. R. 462)</annotation> </annotations> </chapter> <chapter num="09" heading="HIV Testing for Pregnant Women Receiving Prenatal Care" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: August 28, 2006 (33:17 Md. R. 1437)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective December 14, 2009 (36:25 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 27, 2017 (44:6 Md. R. 326)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective May 7, 2018 (45:9 Md. R. 462)</annotation> </annotations> </chapter> <chapter num="10" heading="Urgent Maryland AIDS Drug Assistance Program" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: March 28, 2016 (43:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed effective June 13, 2022 (49:12 Md. R. 640)</annotation> </annotations> </chapter> </subtitle> <subtitle num="19" heading="Dangerous Devices and Substances"> <chapter num="01" heading="Prohibition of Bisphenol-A in Child Care Articles"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes regulations that prohibit the manufacturing, sale, or distribution of child care articles that contain bisphenol-A, also known as BPA.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Bisphenol-A (BPA)” means an industrial chemical also known as 2,2-bis (4-hydroxyphenyl) propane used primarily in the manufacture of polycarbonate plastic and epoxy resins.</text> </paragraph> <paragraph num="(2)"> <text>“Child care article” means an empty bottle or cup to be filled with food or liquid that is designed or intended by a manufacturer to be used by a child younger than 4 years old.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibition of Bisphenol-A in Child Care Articles."> <text>On or after January 1, 2012, a person may not manufacture, knowingly sell, or distribute in commerce a child care article containing bisphenol-A.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements on Manufacturers."> <paragraph num="A."> <text>A manufacturer of a child care article shall use a safe and legal alternative to BPA when replacing BPA in a child care article.</text> </paragraph> <paragraph num="B."> <text>A manufacturer of a child care article may not use in place of BPA a substance determined by the United States Environmental Protection Agency to be a:</text> <paragraph num="(1)"> <text>Group A, B, or C carcinogen; or</text> </paragraph> <paragraph num="(2)"> <text>Reproductive toxicant causing birth defect, reproductive harm, or developmental harm.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Violations."> <text>A person that violates any of the provisions of Health-General Article, §24-304, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $10,000 for each violation.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 28, 2011 (38:24 Md. R. 1502)</annotation> </annotations> </chapter> <chapter num="02" heading="Hazardous Substances"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>All provisions of 16 Code of Federal Regulations, Parts 1500 and 1505, are incorporated by reference, with the following changes set forth below.</text> </paragraph> <paragraph num="B."> <text>1500.3 Definitions.</text> <paragraph num="(1)"> <text>“Act” means the Maryland Hazardous Substance Act, Health-General Article, §22-502, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §22-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 2, 1977 (4:3 Md. R. 145)</annotation> </annotations> </chapter> <chapter num="03" heading="Controlled Dangerous Substances"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>The Secretary of the Maryland Department of Health recognizes that the public interest requires control over the use of controlled substances in the legitimate manufacturing, distributing, dispensing, storing, and ordering of controlled substances.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to every registrant who manufactures, distributes, dispenses, stores, and orders any controlled substances within the State of Maryland, unless exempted from registration by Criminal Law Article, §5-301(d), Annotated Code of Maryland, or 21 CFR §§1301.22 — 1301.24.</text> </paragraph> <paragraph num="C."> <text>In the event of conflict between a provision of the Code of Federal Regulations referenced under a provision of this chapter and the provision of this chapter, the registrant shall comply with the more stringent provision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>In this chapter, 21 CFR §§1300 —1317, as amended, are incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>Applicability to Chapter. In this chapter, the terms defined in §B of this regulation have the meanings indicated. In addition, and unless otherwise provided in this chapter, the definitions appearing in Criminal Law Article, §5-101, Annotated Code of Maryland, shall also apply to this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101—5-1101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative probable cause” means a valid public interest, sufficient to justify an administrative warrant, allowing the inspection of the area, premises, or building to enforce this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Agent” means a person who acts on behalf of the Department.</text> </paragraph> <paragraph num="(4)"> <text>“Authorized provider” or “provider” means a:</text> <paragraph num="(a)"> <text>Person licensed, registered, or otherwise allowed to dispense, order, and store controlled substances;</text> </paragraph> <paragraph num="(b)"> <text>Pharmacy, laboratory, hospital, or other institution licensed, registered, or otherwise allowed to manufacture, distribute, dispense, store, and order controlled substances; or</text> </paragraph> <paragraph num="(c)"> <text>Person licensed, registered, or otherwise allowed to conduct research on a controlled substance in the State in the course of professional practice or research.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Board” means the Maryland Boards of Physicians, Podiatry, Dental Examiners, Nursing, and Veterinary Medicine.</text> </paragraph> <paragraph num="(6)"> <text>“Chemical analysis” means the act of decomposing a substance into its constituent elements.</text> </paragraph> <paragraph num="(7)"> <text>“Civil fine” means a fine assessed by the Department against an authorized provider, including establishments.</text> </paragraph> <paragraph num="(8)"> <text>Commercial Container.</text> <paragraph num="(a)"> <text>“Commercial container” means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user.</text> </paragraph> <paragraph num="(b)"> <text>“Commercial container” includes any box or package in which a receptacle is held for distribution or dispensing to an ultimate user.</text> </paragraph> <paragraph num="(c)"> <text>“Commercial container” does not include any package liner, package insert, or other material kept with or within a commercial container, or any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Controlled Premises.</text> <paragraph num="(a)"> <text>“Controlled premises” means places where original or other records or documents required under the Act are kept or required to be kept.</text> </paragraph> <paragraph num="(b)"> <text>“Controlled premises” includes factories, warehouses, other establishments, and conveyances, where persons registered under the Act or exempt from registration under the Act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(11)"> <text>“Disciplinary action” includes but is not limited to a penalty, reprimand, restriction, suspension, or revocation of a license.</text> </paragraph> <paragraph num="(12)"> <text>“Federal Act” means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).</text> </paragraph> <paragraph num="(13)"> <text>“Fee exempt” means an authorized provider that is required to register with the Department but is not required to pay the registration fee.</text> </paragraph> <paragraph num="(14)"> <text>“In good standing” means having a professional license that is not subject to any form of sanction by the Board or Criminal Law.</text> </paragraph> <paragraph num="(15)"> <text>“Inspector” means an officer or employee of the Department authorized by the Secretary to make inspections under the Act.</text> </paragraph> <paragraph num="(16)"> <text>“Labeling” means all labels and other written, printed, or graphic matter on any controlled substance or any of its commercial containers or wrappers accompanying controlled substances.</text> </paragraph> <paragraph num="(17)"> <text>“License” has the same meaning as State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>Manufacture.</text> <paragraph num="(a)"> <text>“Manufacture” means:</text> <paragraph num="(i)"> <text>Producing, preparation, propagation, compounding, or processing of a drug or other substance;</text> </paragraph> <paragraph num="(ii)"> <text>Packaging or repackaging of the substance; or</text> </paragraph> <paragraph num="(iii)"> <text>Labeling or re-labeling of the commercial container of the substance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Manufacture” does not include the activities of a provider who, as an incident to the provider’s administration or dispensing the substance in the course of the provider’s professional practice, prepares, compounds, packages, or labels the substance.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Manufacturer” means a person who manufactures a drug or other substance under:</text> <paragraph num="(a)"> <text>A registration as a manufacturer; or</text> </paragraph> <paragraph num="(b)"> <text>Authority of registration as a researcher or chemical analyst.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Office of Controlled Substances Administration (OCSA)” refers to the division within the Maryland Department of Health responsible for administering the enforcement of Criminal Law Article, Title 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Penalty” means monetary penalty, including but not limited to a fine.</text> </paragraph> <paragraph num="(22)"> <text>“Person” means:</text> <paragraph num="(a)"> <text>An authorized provider;</text> </paragraph> <paragraph num="(b)"> <text>The responsible party listed on the application licensed by the DEA; or</text> </paragraph> <paragraph num="(c)"> <text>The responsible party listed on the application for an establishment not licensed by the DEA.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Peyote” means the controlled substance in Schedule I under Criminal Law Article, §5-402, Annotated Code of Maryland. This schedule I listing does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church using peyote in this manner are exempt from registration.</text> </paragraph> <paragraph num="(24)"> <text>“Pharmacist” means:</text> <paragraph num="(a)"> <text>A pharmacist licensed in the State or otherwise authorized to dispense controlled substances; or</text> </paragraph> <paragraph num="(b)"> <text>An individual, for example, a pharmacist intern, authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by that state.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>Prescription.</text> <paragraph num="(a)"> <text>“Prescription” means an order for medication that is dispensed to or for an ultimate user.</text> </paragraph> <paragraph num="(b)"> <text>“Prescription” does not include an order for medication which is dispensed for immediate administration to the ultimate user, such as an order to dispense a drug to a bed patient for immediate administration in a hospital.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Registration” means initial registration or subsequent re-registration with OCSA.</text> </paragraph> <paragraph num="(27)"> <text>“Secretary” means the Secretary of the Maryland Department of Health.</text> </paragraph> <paragraph num="(28)"> <text>“Sufficient application” means an application that is completed in full and has provided all of the information required by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Registration: Requirements and Qualifications."> <paragraph num="A."> <text>Except for military and federal employees working within the scope of federal employment, a person shall register with the Department and obtain a registration certificate before the person:</text> <paragraph num="(1)"> <text>Manufactures, distributes, dispenses, stores, and orders controlled substances;</text> </paragraph> <paragraph num="(2)"> <text>Conducts research or instructional activities with controlled substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Conducts research or instructional activities with a controlled substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland, with prior registration from the DEA;</text> </paragraph> <paragraph num="(4)"> <text>Conducts a chemical analysis with controlled substances listed in any schedule;</text> </paragraph> <paragraph num="(5)"> <text>Installs and maintains an automated dispensing machine containing controlled substances; or</text> </paragraph> <paragraph num="(6)"> <text>Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An authorized provider shall:</text> <paragraph num="(1)"> <text>Apply for a registration certificate on a form made available by the Department to:</text> <paragraph num="(a)"> <text>Obtain one registration for all locations that a provider prescribes only and no controlled substances are stored; or</text> </paragraph> <paragraph num="(b)"> <text>Obtain a single registration for each separate location where the provider prescribes, dispenses, orders, and stores controlled substances;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have a professional license in good standing;</text> </paragraph> <paragraph num="(3)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(4)"> <text>Have no convictions for crimes of moral turpitude;</text> </paragraph> <paragraph num="(5)"> <text>Be 18 years of age or older;</text> </paragraph> <paragraph num="(6)"> <text>Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under Health-General Article, §21-2A-04.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(7)"> <text>Except for researchers, have completed 2 continuing education credit hours:</text> <paragraph num="(a)"> <text>Prior to applying for an initial controlled substance registration occurring on or after October 1, 2018; or</text> </paragraph> <paragraph num="(b)"> <text>Prior to the first renewal of a controlled substance registration occurring on or after October 1, 2018.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>The continuing education shall:</text> <paragraph num="(a)"> <text>Be accredited by the Accreditation Council for Continuing Medical Education; or</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for approval by the authorized providers professional board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The continuing education shall pertain to the prescribing or dispensing of controlled substances.</text> </paragraph> <paragraph num="(3)"> <text>Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education.</text> </paragraph> <paragraph num="(4)"> <text>Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An establishment shall:</text> <paragraph num="(1)"> <text>Apply for a registration certificate on a form made available by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Obtain one registration for each separate place of business, professional practice, or location where controlled substances are:</text> <paragraph num="(a)"> <text>Ordered;</text> </paragraph> <paragraph num="(b)"> <text>Purchased;</text> </paragraph> <paragraph num="(c)"> <text>Administered;</text> </paragraph> <paragraph num="(d)"> <text>Delivered to the ultimate user;</text> </paragraph> <paragraph num="(e)"> <text>Stored;</text> </paragraph> <paragraph num="(f)"> <text>Manufactured; or</text> </paragraph> <paragraph num="(g)"> <text>Distributed; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances:</text> <paragraph num="(a)"> <text>Manufacture;</text> </paragraph> <paragraph num="(b)"> <text>Distribute;</text> </paragraph> <paragraph num="(c)"> <text>Deliver to the ultimate user;</text> </paragraph> <paragraph num="(d)"> <text>Administer;</text> </paragraph> <paragraph num="(e)"> <text>Store;</text> </paragraph> <paragraph num="(f)"> <text>Order;</text> </paragraph> <paragraph num="(g)"> <text>Prescribe;</text> </paragraph> <paragraph num="(h)"> <text>Package;</text> </paragraph> <paragraph num="(i)"> <text>Label; or</text> </paragraph> <paragraph num="(j)"> <text>Compound.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration: Application."> <paragraph num="A."> <text>A person shall complete an application to be considered for a registration certificate.</text> </paragraph> <paragraph num="B."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Submit a completed application made available by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Except for fee exempt applicants, pay the appropriate fee as set forth in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Unless exempt from payment of a registration fee, apply for and obtain a registration certificate;</text> </paragraph> <paragraph num="(4)"> <text>Provide an explanation for any not-applicable responses on the applications;</text> </paragraph> <paragraph num="(5)"> <text>Notify the Department of any criminal convictions related to controlled substances;</text> </paragraph> <paragraph num="(6)"> <text>Notify the Department of any actions taken on the applicant’s professional license;</text> </paragraph> <paragraph num="(7)"> <text>Have the application and accompanying documents required for registration signed by the:</text> <paragraph num="(a)"> <text>Applicant, if an individual;</text> </paragraph> <paragraph num="(b)"> <text>General partner, if the applicant is a partnership; or</text> </paragraph> <paragraph num="(c)"> <text>Officer responsible for the applicant, if the applicant is a corporation or other entity; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Provide additional documentation required by the Department pertinent to the registration, to:</text> <paragraph num="(a)"> <text>Clarify application information; and</text> </paragraph> <paragraph num="(b)"> <text>Determine if the applicant meets the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>New applications that are unable to be processed 6 months from the payment deposit date:</text> <paragraph num="(1)"> <text>May be determined invalid;</text> </paragraph> <paragraph num="(2)"> <text>Will not be issued a refund, unless:</text> <paragraph num="(a)"> <text>The payment is a duplicate; or</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Will require a new application to be resubmitted.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Renewal applications that are unable to be processed 45 days from the payment deposit date:</text> <paragraph num="(1)"> <text>May be determined invalid;</text> </paragraph> <paragraph num="(2)"> <text>Will not be issued a refund, unless:</text> <paragraph num="(a)"> <text>The payment is a duplicate; or</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Department; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Will require a new renewal application to be submitted.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Registration: Fees."> <paragraph num="A."> <text>An authorized provider or establishment required to obtain and maintain a registration certificate as set forth under this chapter shall pay the appropriate fees as follows:</text> <paragraph num="(1)"> <text>New registration certificate — $120;</text> </paragraph> <paragraph num="(2)"> <text>Renewal registration certificate — $120;</text> </paragraph> <paragraph num="(3)"> <text>Amend a registration certificate — $50;</text> </paragraph> <paragraph num="(4)"> <text>Change of ownership fee — $144;</text> </paragraph> <paragraph num="(5)"> <text>Duplicate registration certificate — $30; and</text> </paragraph> <paragraph num="(6)"> <text>Reinstatement — $50.00.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applicants exempt from registration fees include:</text> <paragraph num="(1)"> <text>Except for contractual positions, an employee of a hospital, clinic, institution, facility, or unit operated by a local or State government agency;</text> </paragraph> <paragraph num="(2)"> <text>An agency, excluding a State agency and its employees, for which the State is responsible for payment of the fee, provided that the exemption is approved by the Secretary; or</text> </paragraph> <paragraph num="(3)"> <text>A person included in 21 CFR §§1301.21.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Refunds and Credits.</text> <paragraph num="(1)"> <text>The Secretary may not issue a credit towards or refund any registration fees to an applicant, including but not limited to, an applicant who:</text> <paragraph num="(a)"> <text>Withdraws a registration application;</text> </paragraph> <paragraph num="(b)"> <text>Voluntarily or involuntarily ceases to manufacture, distribute, dispense, order, and store a controlled substances before a registration certificate expires; or</text> </paragraph> <paragraph num="(c)"> <text>Does not complete the application as set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary, or the Secretary’s designee, shall review the refund request and determine if a refund of any amount is appropriate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A registrant who has lost a registration certificate is required to pay a duplicate registration fee as set forth in §A of this regulation.</text> </paragraph> <paragraph num="E."> <text>The Department may not issue a new or a renewed registration certificate until all required fees are paid.</text> </paragraph> <paragraph num="F."> <text>The Department-issued registration certificate shall be readily available to any agent or representative of the Secretary within the registered location.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Registration: Term, Expiration, Renewal, and Reinstatement."> <paragraph num="A."> <text>Term. The Secretary may issue a registration certificate that is valid for not more than 3 years.</text> </paragraph> <paragraph num="B."> <text>Expiration.</text> <paragraph num="(1)"> <text>A registration certificate expires on the date shown on the certificate.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary shall notify the registrant that the registration will expire not less than 30 days before the expiration date shown on the certificate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Renewal.</text> <paragraph num="(1)"> <text>A registration for which a sufficient application for renewal was submitted:</text> <paragraph num="(a)"> <text>Shall be received at least 2 weeks before the expiration; and</text> </paragraph> <paragraph num="(b)"> <text>Will remain in effect until the Department takes a final action.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The failure to receive a renewal notice does not excuse a registrant from complying with this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A registrant whose registration has been surrendered in lieu of further investigation, revoked, suspended, or limited may not be eligible to request reinstatement for a:</text> <paragraph num="(a)"> <text>2-year period;</text> </paragraph> <paragraph num="(b)"> <text>Specified period designated in a consent order from the Department; or</text> </paragraph> <paragraph num="(c)"> <text>Specified time period determined by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To apply for reinstatement, a registrant shall:</text> <paragraph num="(a)"> <text>Complete and submit an application on a form provided by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Pay a reinstatement fee shown in Regulation .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Registration Certificate: Assignment, Transfer, or Termination."> <paragraph num="A."> <text>A registration certificate is not transferable.</text> </paragraph> <paragraph num="B."> <text>A registration certificate becomes void when the registrant:</text> <paragraph num="(1)"> <text>Dies;</text> </paragraph> <paragraph num="(2)"> <text>Discontinues business or professional practice in the State; or</text> </paragraph> <paragraph num="(3)"> <text>Changes ownership, including when:</text> <paragraph num="(a)"> <text>Partners are added or deleted from the partnership;</text> </paragraph> <paragraph num="(b)"> <text>There is a change in the president or chief executive officer of the corporation; or</text> </paragraph> <paragraph num="(c)"> <text>There is a change in the ownership of 10 percent or more of the outstanding shares in the corporation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A registrant who discontinues business or professional practice in the State shall:</text> <paragraph num="(1)"> <text>Notify the Secretary in writing;</text> </paragraph> <paragraph num="(2)"> <text>Surrender the registrant’s current registration certificate; and</text> </paragraph> <paragraph num="(3)"> <text>Legally transfer or dispose of any controlled substances relative to the registrant’s operation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A registrant who changes ownership of the business or professional practice shall:</text> <paragraph num="(1)"> <text>Notify the Secretary in writing at least 30 days before the change occurs;</text> </paragraph> <paragraph num="(2)"> <text>Complete and submit a change of ownership application to the Department;</text> </paragraph> <paragraph num="(3)"> <text>Pay the change-of-ownership fee in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Surrender the registrant’s current registration certificate after the ownership change is finalized; and</text> </paragraph> <paragraph num="(5)"> <text>Allow the Department to inspect the business or professional practice of the new owners.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A registrant who changes the location of a registrant’s place of business or professional practice shall:</text> <paragraph num="(1)"> <text>Notify the Department at least 30 days before there is a change in the location of the registrant’s place of business or professional practice;</text> </paragraph> <paragraph num="(2)"> <text>Apply to amend a current registration certificate; and</text> </paragraph> <paragraph num="(3)"> <text>Pay the fee to amend a certificate in Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>During the 3-year registration period, the registrant shall notify the Office of Controlled Substances Administration within 30 days of the following:</text> <paragraph num="(1)"> <text>Any criminal convictions;</text> </paragraph> <paragraph num="(2)"> <text>Any disciplinary actions taken against the registrant’s professional or occupational license; or</text> </paragraph> <paragraph num="(3)"> <text>Any disciplinary actions taken against the registrant’s federal Drug Enforcement Agency registration.</text> </paragraph> </paragraph> <paragraph num="G."> <text>After an application for registration has been filed, the Secretary may:</text> <paragraph num="(1)"> <text>Inspect the place of business or professional practice described in the application; and</text> </paragraph> <paragraph num="(2)"> <text>Investigate the applicant to determine whether the applicant meets the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The registrant shall inform the Office of Controlled Substances Administration prior to any address changes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Labeling and Packaging Requirements for Controlled Substances."> <text>A registrant shall comply with the provisions of 21 CFR §1302, as amended.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Records and Reports Required of Registrants."> <paragraph num="A."> <text>Pursuant to Criminal Law Article, §5-306, Annotated Code of Maryland, a registrant shall comply with the provisions of 21 CFR §1304, as amended.</text> </paragraph> <paragraph num="B."> <text>Inventories developed under the Federal Act dated May 1, 1971, and subsequent biennial inventory dates are acceptable for purposes of the Maryland Act.</text> </paragraph> <paragraph num="C."> <text>On the effective date a substance is added to any schedule of controlled substances pursuant to Criminal Law Article, §5-202, Annotated Code of Maryland, registrants required to keep records, who possess that substance, shall take an inventory of all stocks of that substance on hand. Thereafter, that substance shall be included in each inventory made by the registrant.</text> </paragraph> <paragraph num="D."> <text>Reports required in this section shall be accessible to the representative of the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Order Forms."> <text>A registrant shall comply with the provisions of 21 CFR 1305, as amended.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Prescriptions."> <paragraph num="A."> <text>Persons Entitled to Issue Prescriptions.</text> <paragraph num="(1)"> <text>A prescription for a controlled substance may be issued only by an authorized provider who is:</text> <paragraph num="(a)"> <text>Authorized to prescribe controlled substances in the State of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Either registered or exempted from registration pursuant to 21 CFR §1301.22(c) and 21 CFR §1301.23.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A prescription issued by an authorized provider may be communicated to a pharmacist by an employee or agent of the authorized provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Purpose of Issue of Prescription.</text> <paragraph num="(1)"> <text>A controlled substance prescription shall only be issued for a legitimate medical purpose by a provider.</text> </paragraph> <paragraph num="(2)"> <text>A controlled substance prescription shall be issued by a provider in the usual course of the individual provider’s professional practice.</text> </paragraph> <paragraph num="(3)"> <text>The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing provider.</text> </paragraph> <paragraph num="(4)"> <text>A pharmacist has a corresponding responsibility to ensure, prior to dispensing, that a controlled substance prescription is issued for a legitimate medical purpose.</text> </paragraph> <paragraph num="(5)"> <text>An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-501—5-505, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>A prescription may not be issued in order for an individual provider to obtain controlled substances for supplying the individual provider for the purpose of general dispensing to patients.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A prescription for a Schedule II-V controlled substance shall be dispensed within 120 days from the date of issue.</text> </paragraph> <paragraph num="D."> <text>Unless the State has stricter requirements, if a provider has complied with 21 CFR §1306, the provider is deemed to have complied with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Partial Fill of a Prescription."> <text>A partial fill of a C-II prescription is permitted if:</text> <paragraph num="A."> <text>The pharmacist is unable to fill the full quantity of the prescription, pursuant to 21 CFR §1306.13(a);</text> </paragraph> <paragraph num="B."> <text>The prescription is issued for a patient in a long-term care facility or for a patient with a medical diagnosis documenting a terminal illness pursuant to 21 CFR 1306.13(b) or (c);</text> </paragraph> <paragraph num="C."> <text>Requested by the patient or the practitioner that wrote the prescription, pursuant to 21 CFR §1306.13(b); or</text> </paragraph> <paragraph num="D."> <text>The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Refilling of Prescriptions."> <paragraph num="A."> <text>A prescription for a controlled substance listed in Schedule II may not be refilled.</text> </paragraph> <paragraph num="B."> <text>A prescription for a controlled substance listed in Schedule III, IV, or V:</text> <paragraph num="(1)"> <text>May not be refilled more than 6 months after the date on which the prescription was issued;</text> </paragraph> <paragraph num="(2)"> <text>May not be refilled more than five times; and</text> </paragraph> <paragraph num="(3)"> <text>Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The prescribing provider may authorize additional refills of Schedule III, IV, or V substances on the original prescription through an oral refill authorization transmitted to the pharmacist if the following conditions are met:</text> <paragraph num="(1)"> <text>The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription;</text> </paragraph> <paragraph num="(2)"> <text>The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription;</text> </paragraph> <paragraph num="(3)"> <text>The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and</text> </paragraph> <paragraph num="(4)"> <text>The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Required Documentation.</text> <paragraph num="(1)"> <text>Each refilling of a prescription shall be documented on the:</text> <paragraph num="(a)"> <text>Back of the prescription;</text> </paragraph> <paragraph num="(b)"> <text>With Department approval, on another appropriate uniformly maintained, readily retrievable record, such as medication records; or</text> </paragraph> <paragraph num="(c)"> <text>electronic prescription record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The documentation shall indicate the:</text> <paragraph num="(a)"> <text>Number of the prescription;</text> </paragraph> <paragraph num="(b)"> <text>Name of the controlled substance;</text> </paragraph> <paragraph num="(c)"> <text>Dosage form of the controlled substance;</text> </paragraph> <paragraph num="(d)"> <text>Date of each refilling;</text> </paragraph> <paragraph num="(e)"> <text>Quantity dispensed;</text> </paragraph> <paragraph num="(f)"> <text>Identity or initials of the dispensing pharmacist in each refilling;</text> </paragraph> <paragraph num="(g)"> <text>Total number of refills for that prescription;</text> </paragraph> <paragraph num="(h)"> <text>Pharmacist’s initials; and</text> </paragraph> <paragraph num="(i)"> <text>Date by the pharmacist as of the date of dispensing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Each refilling of a prescription shall:</text> <paragraph num="(a)"> <text>State the amount dispensed; or</text> </paragraph> <paragraph num="(b)"> <text>If the amount dispensed is not specifically stated, be deemed to have been dispensed for the full face amount of the prescription.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Physical Security Controls for Registrants."> <text>A registrant shall comply with the provisions of 21 CFR §§1301.71—1301.77 as amended.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Controlled Substance Disposal."> <paragraph num="A."> <text>Any registrant in possession of legally obtained controlled substances and desiring or required to dispose of any of these substances may ask the Office of Controlled Substances Administration of the Maryland Department of Health for authority and instructions to dispose of this substance. This does not eliminate the requirement on registrants under federal regulations to report destruction of controlled dangerous substances.</text> </paragraph> <paragraph num="B."> <text>Disposal of Medical Waste.</text> <paragraph num="(1)"> <text>A registrant in possession of legally obtained controlled substances deemed medical waste shall render the controlled substances irretrievable by disposing of:</text> <paragraph num="(a)"> <text>Liquid waste in an approved containment unit; or</text> </paragraph> <paragraph num="(b)"> <text>Non-liquid in a receptacle.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Two licensed personnel shall keep Waste Destruction Logbooks and maintain the record for 2 years. The Destruction Log shall be readily available upon inspection.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Disposal for Registrants Required to Register with the DEA.</text> <paragraph num="(1)"> <text>The Office of Controlled Substances Administration shall authorize and instruct the registrant to dispose of the controlled substance in one of the following manners, provided complete records of the disposition are maintained by the registrant:</text> <paragraph num="(a)"> <text>By transfer to a person registered under the Act and authorized to possess the substance;</text> </paragraph> <paragraph num="(b)"> <text>By destruction in the presence of an agent of the Office of Controlled Substances Administration or another authorized person;</text> </paragraph> <paragraph num="(c)"> <text>By forwarding to the District Office of the Drug Enforcement Administration pursuant to the procedures of that agency;</text> </paragraph> <paragraph num="(d)"> <text>By returning unused controlled substances dispensed by registered hospital pharmacies for administration to in-patients to the pharmacy for appropriate disposition; or</text> </paragraph> <paragraph num="(e)"> <text>By other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A registrant that has complied with 21 CFR §1304 is deemed to have complied with this section.</text> </paragraph> <paragraph num="(3)"> <text>If a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge of the Federal Drug Enforcement Administration may authorize the registrant to dispose of these substances, in accordance with 21 CFR §1307.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Disposal for Registrants Not required to Register with the DEA. Any registrant who is registered to administer only and is in possession of legally obtained controlled substances shall:</text> <paragraph num="(1)"> <text>List the controlled substance or substances which the registrant desires to dispose of on a drug destruction form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Have two members of the professional staff, limited to an administrator, nurse, or pharmacist, destroy controlled drugs on premises;</text> </paragraph> <paragraph num="(3)"> <text>Dispose per instructions given in §B of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Forward a copy of the completed drug destruction form to the Office of Controlled Substances Administration within 10 days of destruction; and</text> </paragraph> <paragraph num="(5)"> <text>Keep a copy of the drug disposal form on location for a period of 2 years.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Abandoned controlled substances may be:</text> <paragraph num="(1)"> <text>Destroyed in the presence of an agent of the Office of Controlled Substances Administration or another authorized person or persons;</text> </paragraph> <paragraph num="(2)"> <text>Disposed of by other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons; or</text> </paragraph> <paragraph num="(3)"> <text>Impounded under Health-General Article, §21-1113, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Aforementioned procedures do not preclude release of medication to discharged patients if ordered in writing by the attending physician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Transfer of Controlled Substances."> <paragraph num="A."> <text>When closing business activities, a registrant shall:</text> <paragraph num="(1)"> <text>Dispose of all controlled dangerous substances in accordance with Regulation .16 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Return the controlled substances registration certificate to the Office of Controlled Substances Administration inspector at the time of the closing inspection.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Change of Ownership.</text> <paragraph num="(1)"> <text>A Change of Ownership requires the registrant to notify the Department in writing, Attention to the Office of Controlled Substances Administration.</text> </paragraph> <paragraph num="(2)"> <text>The written notification shall be submitted:</text> <paragraph num="(a)"> <text>In person;</text> </paragraph> <paragraph num="(b)"> <text>By registered mail; or</text> </paragraph> <paragraph num="(c)"> <text>By certified mail with a return receipt request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The written notification must be received 14 days before the transfer occurs.</text> </paragraph> <paragraph num="(4)"> <text>The Secretary has the authority to waive the 14-day time limitation in individual instances.</text> </paragraph> <paragraph num="(5)"> <text>The written notification shall contain the following information:</text> <paragraph num="(a)"> <text>The name;</text> </paragraph> <paragraph num="(b)"> <text>The address;</text> </paragraph> <paragraph num="(c)"> <text>The registration number; and</text> </paragraph> <paragraph num="(d)"> <text>The authorized business activity of the:</text> <paragraph num="(i)"> <text>Registrant-transferor discontinuing the business; and</text> </paragraph> <paragraph num="(ii)"> <text>Registrant-transferee acquiring the business;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Whether the business activities will be:</text> <paragraph num="(i)"> <text>Continued at the location registered by the person discontinuing business; or</text> </paragraph> <paragraph num="(ii)"> <text>Moved to another location and, if so, the address of the new location; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The date on which the transfer of controlled substances will occur.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except for transfer denials by the Secretary, the registrant-transferor may distribute, without being registered to distribute, controlled substances in the registrant-transferor’s possession to the registrant-transferee in accordance with the following procedures, on the date of transfer of the controlled substances:</text> <paragraph num="(a)"> <text>A complete inventory of all controlled substances being transferred shall be taken and serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the inventory shall be included in the records of both the transferor and transferee;</text> </paragraph> <paragraph num="(c)"> <text>A copy of the inventory shall be filed with the Department if requested by the Secretary;</text> </paragraph> <paragraph num="(d)"> <text>Transfers of Schedule I or II controlled substances shall require the use of order forms in accordance with 21 CFR §1305;</text> </paragraph> <paragraph num="(e)"> <text>All transferor-controlled substance records shall be transferred to the transferee; and</text> </paragraph> <paragraph num="(f)"> <text>Pursuant to 21 CFR §1304, transferors are required to make reports, which shall be marked as “Final”.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Administrative Inspections and Warrants."> <paragraph num="A."> <text>Administrative Inspections.</text> <paragraph num="(1)"> <text>Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Authority to make inspections is authorized in accordance with Criminal Law Article, §§5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following:</text> <paragraph num="(a)"> <text>Documents required to be kept or made pursuant to 21 CFR §1304, under the Act, or regulations promulgated under the Act may be:</text> <paragraph num="(i)"> <text>Inspected;</text> </paragraph> <paragraph num="(ii)"> <text>Copied;</text> </paragraph> <paragraph num="(iii)"> <text>Verified for correctness; and</text> </paragraph> <paragraph num="(iv)"> <text>Inventoried;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Collecting samples of controlled substances or precursors (if samples are collected during an inspection, the inspector shall issue a receipt for these samples to the owner, operator, or agent in charge of the premises);</text> </paragraph> <paragraph num="(c)"> <text>Review of records and information on the distribution of controlled substances by the authorized provider;</text> </paragraph> <paragraph num="(d)"> <text>Reviewing the authorized providers processes;</text> </paragraph> <paragraph num="(e)"> <text>Reviewing the authorized providers controls; and</text> </paragraph> <paragraph num="(f)"> <text>Inspecting the authorized providers facility operations;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Entry.</text> <paragraph num="(a)"> <text>An inspection shall be carried out by an inspector.</text> </paragraph> <paragraph num="(b)"> <text>An inspector shall have the right to enter the premises and conduct inspections at reasonable times and in a reasonable manner, upon the following conditions:</text> <paragraph num="(i)"> <text>Stating the inspector’s purpose; and</text> </paragraph> <paragraph num="(ii)"> <text>Presenting to the owner, operator, or agent in charge of the premises to be inspected, appropriate credentials and written notice of the inspector’s inspection authority under Criminal Law Article, §5-305, 5-804, or 5-805, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Consent to Inspection of Financial Data, Sales Data Other than Shipment Data, or Pricing Data.</text> <paragraph num="(a)"> <text>If inspection is desired of financing, sales, or pricing data, written consent shall first be obtained from the owner, operator, or agent in charge of the premises to be inspected.</text> </paragraph> <paragraph num="(b)"> <text>This written consent shall contain the following information:</text> <paragraph num="(i)"> <text>That the owner, operator, or agent in charge has the right to refuse to consent to an inspection of these items;</text> </paragraph> <paragraph num="(ii)"> <text>That anything of an incriminating nature which may be found may be seized and used against the owner, operator, or agent in charge in a criminal prosecution;</text> </paragraph> <paragraph num="(iii)"> <text>That the owner, operator, or agent in charge has been presented with a notice of inspection;</text> </paragraph> <paragraph num="(iv)"> <text>That the consent is given by the owner, operator, or agent in charge voluntarily and without threats of any kind; and</text> </paragraph> <paragraph num="(v)"> <text>That the owner, operator, or agent in charge may withdraw the owner’s, operator’s, or agent in charge’s consent at any time during the course of inspection.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The written consent shall be produced in duplicate and be distributed as follows:</text> <paragraph num="(i)"> <text>The original will be retained by the inspector; and</text> </paragraph> <paragraph num="(ii)"> <text>The duplicate will be given to the authorized provider inspected.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Administrative Warrants.</text> <paragraph num="(1)"> <text>Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant.</text> </paragraph> <paragraph num="(2)"> <text>Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, §5-804(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the authorized provider or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Hearings, Enforcement, and Disciplinary Sanctions."> <paragraph num="A."> <text>Authority for Enforcement Proceeding.</text> <paragraph num="(1)"> <text>A hearing may be ordered or granted by the Secretary, at the Secretary’s discretion, to permit any person against whom criminal or civil action is contemplated under the Controlled Dangerous Substances Act an opportunity to present the individual’s views and the individual’s proposals for bringing the individual’s alleged violations into compliance with the law. The hearing will also permit the individual to show cause why prosecution should not be instituted, or to present the individual’s views on the contemplated proceeding.</text> </paragraph> <paragraph num="(2)"> <text>The rules of procedure for hearings before the Secretary of the Maryland Department of Health shall be governed by COMAR 10.01.03 and State Government Article, §§10-201—10-226, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Administrative Hearings. Procedures for administrative hearings shall be governed by the rules set forth in Criminal Law Article, §5-308, if applicable, Health-General Article, §2-207, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>After a hearing pursuant to Criminal Law Article, §5-308, if applicable, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03, the Secretary may impose a sanction or penalty against any registrant that possesses a Maryland-issued controlled substances registration pursuant to Criminal Law Article, Title V, Annotated Code of Maryland, instead of or in addition to:</text> <paragraph num="(1)"> <text>The denial of an application;</text> </paragraph> <paragraph num="(2)"> <text>The refusal to renew a registration;</text> </paragraph> <paragraph num="(3)"> <text>Suspending a registration;</text> </paragraph> <paragraph num="(4)"> <text>Revoking a registration;</text> </paragraph> <paragraph num="(5)"> <text>Placing restrictions on a registration pursuant to Criminal Law Article, §5-307, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(6)"> <text>Issuing a nonpublic advisory letter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Imposition of Monetary Penalty.</text> <paragraph num="(1)"> <text>After a hearing pursuant to Criminal Law Article, §5-308, Annotated Code of Maryland, the Department may impose a monetary penalty against a controlled substance registration holder pursuant to Criminal Law Article, §5-908, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The monetary penalty may be imposed instead of or in addition to the:</text> <paragraph num="(a)"> <text>Suspension of the controlled substances registration;</text> </paragraph> <paragraph num="(b)"> <text>Revocation of the controlled substances registration; or</text> </paragraph> <paragraph num="(c)"> <text>Restrictions placed on the controlled substances registration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The monetary penalty shall be paid within 30 calendar days of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(4)"> <text>Until the imposed fine is paid, the registration may not be:</text> <paragraph num="(a)"> <text>Restored;</text> </paragraph> <paragraph num="(b)"> <text>Reinstated; or</text> </paragraph> <paragraph num="(c)"> <text>Renewed.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In its discretion, the Department may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management for collection.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Department and the registrant may agree to a surrender of a registration, or a consent order with terms, sanction, and penalties agreed to by the Department and the registrant.</text> </paragraph> <paragraph num="E."> <text>Nothing in this chapter prohibits the Department from staying any period of non-active suspension.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Additional Controlled Substances in Maryland."> <paragraph num="A."> <text>The following substance, also known as a “bath salt”, is added to the Maryland Controlled Dangerous Substances Act, Schedule I of the Criminal Law Article, §5-402, Annotated Code of Maryland: F. 4-Methoxymethcathinone (Methedrone, bk-PMMA, PMMC).</text> </paragraph> <paragraph num="B."> <text>The following substances are added to the Maryland Controlled Dangerous Substances Act, Schedule III of the Criminal Law Article, §5-404, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Butalbital, Acetaminophen, caffeine C-III Fioricet®; and</text> </paragraph> <paragraph num="(2)"> <text>Opium < or = 100mg per 100Gm or 100ml or not more than 5mg per dosage unit C-III.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Criminal Law Article, Title 5; Health-General Article, §21-220; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 1977 (4:2 Md. R. 87)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 17, 1984 (11:25 Md. R. 2134); February 17, 1992 (19:3 Md. R. 304); December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E and J amended effective August 17, 1992 (19:16 Md. R. 1474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective July 12, 1998 (25:14 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07N, R and .10B amended effective February 10, 1978 (5:3 Md. R. 138)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G amended effective March 30, 1992 (19:6 Md. R. 673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective April 18, 1980 (7:8 Md. R. 771)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 26, 2004 (31:8 Md. R. 646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective April 24, 2006 (33:8 Md. R. 732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 1, 2016 (42:22 Md. R. 1377)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted as an emergency provision effective October 18, 2011 (38:24 Md. R. 1495); adopted permanently effective December 26, 2011 (38:26 Md. R. 1697)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective October 14, 2024 (51:20 Md. R. 899)</annotation> </annotations> </chapter> <chapter num="04" heading="Prohibition of Smoking or Vaping in Public Indoor Areas"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes regulations that preserve and improve the health, comfort, and environment of the people of the State by protecting the public and employees from involuntary exposure to environmental smoke in indoor areas open to the public, except for those covered by Health-General Article, §24-205, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter preempts a county or municipal government from enacting and enforcing more stringent measures to protect the public from involuntary exposure to environmental smoke in indoor areas open to the public.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means the Clean Indoor Air Act of 2007, Health-General Article, Title 24, Subtitle 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Cannabis” has the meaning stated in the Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Club” means a club as defined in Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Day care transportation” means the use of a vehicle owned, operated, or contracted for by a licensed day care facility to transport the facility's clients.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Electronic smoking device” has the meaning stated in Business Regulation Article, §16.7-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Environmental smoke” means the complex mixture formed from the:</text> <paragraph num="(a)"> <text>Smoke of a burning tobacco, cannabis, or hemp product, or exhaled by the smoker; or</text> </paragraph> <paragraph num="(b)"> <text>Aerosol of an electronic smoking device or exhaled as electronic smoking device aerosol.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Establishment” means a single physical location where business is conducted or where services are performed.</text> </paragraph> <paragraph num="(9)"> <text>“Health care transportation” means transportation of patients for medical care in a vehicle owned, operated, or contracted for by a licensed health care facility.</text> </paragraph> <paragraph num="(10)"> <text>“Health officer” means the health officer of each of the 23 counties and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(11)"> <text>“Hemp” has the meaning stated in the Agriculture Article, §14-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Indoor area” means all space in a structure or building with a ceiling that is enclosed on all sides by any combination of permanent or temporary walls, windows, or doorways, whether open or closed, or other physical barriers extending from floor to the ceiling.</text> </paragraph> <paragraph num="(13)"> <text>“Indoor area open to the public” means:</text> <paragraph num="(a)"> <text>An indoor area or a portion of an indoor area accessible to the public by either invitation or permission; or</text> </paragraph> <paragraph num="(b)"> <text>An indoor area of an establishment licensed or permitted under the Alcoholic Beverages and Cannabis Article, Annotated Code of Maryland, for the sale or possession of alcoholic beverages.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Owner” means an individual or entity having an ownership interest in an establishment or vehicle.</text> </paragraph> <paragraph num="(15)"> <text>“Person in charge” means an owner, operator, manager, or other person who controls, governs, or directs the activities of an establishment.</text> </paragraph> <paragraph num="(16)"> <text>“Public transportation of children” means the transportation of children in a vehicle owned, operated, or contracted for by a government entity or a private educational institution.</text> </paragraph> <paragraph num="(17)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(18)"> <text>“Smoking” means the burning of a lighted cigarette, cigar, pipe, or another matter or substance containing, wholly or in part, tobacco, cannabis, or hemp.</text> </paragraph> <paragraph num="(19)"> <text>“Tobacco product” has the meaning stated in Health-General Article, §13-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Vaping” means the use of:</text> <paragraph num="(a)"> <text>An electronic smoking device; or</text> </paragraph> <paragraph num="(b)"> <text>Any device through which the user inhales aerosol containing tobacco, cannabis, or hemp.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Exclusions."> <text>This chapter does not apply to:</text> <paragraph num="A."> <text>Private homes and residences, including a residence used as a business or place of employment, unless being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care;</text> </paragraph> <paragraph num="B."> <text>Private vehicles, unless being used:</text> <paragraph num="(1)"> <text>For the public transportation of children; or</text> </paragraph> <paragraph num="(2)"> <text>As part of health care or day care transportation;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A hotel or motel room rented to one or more guests, if the total percent of hotel or motel rooms being rented where smoking or vaping is allowed, does not exceed 25 percent of the guest rooms in the hotel or motel;</text> </paragraph> <paragraph num="D."> <text>A retail tobacco business that is a sole proprietorship, limited liability company, corporation, partnership, or other enterprise, in which:</text> <paragraph num="(1)"> <text>The primary activity is the retail sale of tobacco products and accessories; and</text> </paragraph> <paragraph num="(2)"> <text>The sale of other products is incidental;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A facility of a manufacturer, importer, wholesaler, or distributor of tobacco-containing products or a tobacco leaf dealer or processor in which employees of the manufacturer, importer, wholesaler, distributor, or processor work or congregate; and</text> </paragraph> <paragraph num="F."> <text>A research or educational laboratory for the purpose of conducting scientific research into the health effects of environmental smoke.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prohibition of Smoking or Vaping."> <text>Except as provided in Regulation .03 of this chapter, an individual may not smoke or vape in:</text> <paragraph num="A."> <text>An indoor area open to the public;</text> </paragraph> <paragraph num="B."> <text>An indoor place in which a meeting is open to the public in accordance with State Government Article, Title 10, Subtitle 5, Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>An indoor place of employment;</text> </paragraph> <paragraph num="D."> <text>A government-owned or government-operated means of mass transportation, including:</text> <paragraph num="(1)"> <text>Buses;</text> </paragraph> <paragraph num="(2)"> <text>Vans;</text> </paragraph> <paragraph num="(3)"> <text>Trains;</text> </paragraph> <paragraph num="(4)"> <text>Taxicabs; and</text> </paragraph> <paragraph num="(5)"> <text>Limousines;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A private home or residence that is being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care; and</text> </paragraph> <paragraph num="F."> <text>A private vehicle while it is being used:</text> <paragraph num="(1)"> <text>For the public transportation of children; or</text> </paragraph> <paragraph num="(2)"> <text>As part of health care or day care transportation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Owner Requirements."> <paragraph num="A."> <text>The owner of a bar, club as defined in Regulation .02B of this chapter, restaurant, pub, tavern, retail establishment, theater, concert hall, athletic facility, financial service institution, government building, educational institution, museum, or library shall:</text> <paragraph num="(1)"> <text>Prohibit smoking or vaping in an indoor area open to the public; and</text> </paragraph> <paragraph num="(2)"> <text>Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06A of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An owner of a hotel or motel shall:</text> <paragraph num="(1)"> <text>Prohibit smoking or vaping in an indoor area open to the public except where smoking or vaping is permitted under Regulation .03C of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Post a sign indicating where smoking or vaping is permitted or prohibited, as set forth in Regulation .06B and C of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An owner of a vehicle listed in Regulation .04D of this chapter shall:</text> <paragraph num="(1)"> <text>Prohibit smoking or vaping in the vehicle; and</text> </paragraph> <paragraph num="(2)"> <text>Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06D of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An owner of an establishment containing an indoor area open to the public not listed in Regulation .05A—C of this chapter shall prohibit smoking or vaping in an indoor area open to the public.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Posting of Signs."> <paragraph num="A."> <text>An indoor area open to the public and every public entrance to an indoor area open to the public where smoking or vaping is prohibited under Regulation .05A of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter.</text> </paragraph> <paragraph num="B."> <text>A hotel or motel room in which smoking or vaping is permitted shall display a sign containing the words “SMOKING OR VAPING PERMITTED IN THIS ROOM” conforming to the following requirements:</text> <paragraph num="(1)"> <text>The words “SMOKING OR VAPING PERMITTED IN THIS ROOM” are in capital letters;</text> </paragraph> <paragraph num="(2)"> <text>The background and the print are in contrasting colors; and</text> </paragraph> <paragraph num="(3)"> <text>The letters “SMOKING OR VAPING PERMITTED IN THIS ROOM” on the sign are a minimum of 1 inch in height.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An indoor area open to the public and every public entrance to an indoor area open to the public where smoking is prohibited in a hotel or motel shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter.</text> </paragraph> <paragraph num="D."> <text>A vehicle where smoking is prohibited under Regulation .04D of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter.</text> </paragraph> <paragraph num="E."> <text>Sign Requirements. A “NO SMOKING OR VAPING” sign:</text> <paragraph num="(1)"> <text>Shall contain the words “NO SMOKING OR VAPING” composed of letters at least one inch in height;</text> </paragraph> <paragraph num="(2)"> <text>May contain the following symbols:</text> <paragraph num="(a)"> <text>The international symbol for “no smoking”, consisting of a pictorial representation of a burning cigarette enclosed in a circle with a bar across the circle;</text> </paragraph> <paragraph num="(b)"> <text>The international symbol for “no smoking” and pictorial representation of an electronic smoking device enclosed in a circle with a bar across the circle or pictorial representations of an electronic smoking device and a cannabis leaf, enclosed in separate circles, with a bar across each circle;</text> </paragraph> <paragraph num="(c)"> <text>A modified international symbol for “No Smoking”, consisting of a circle with a bar across the circle, with the circle containing pictorial representations of a burning cigarette and an electronic smoking device or electronic smoking device and a cannabis leaf; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §E(2)(a)—(c) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>May contain additional information, such as:</text> <paragraph num="(a)"> <text>The words, “For information on quitting smoking, call 1-800-QUIT NOW (1-800-784-8669)”;</text> </paragraph> <paragraph num="(b)"> <text>The words “WARNING: TOBACCO SMOKE CAUSES CANCER AND HEART DISEASE AND CAN HARM YOUR CHILD.”; or</text> </paragraph> <paragraph num="(c)"> <text>The words “WARNING: CANNABIS SMOKE CAN HARM LUNG TISSUE AND HAS MANY OF THE SAME CARCINOGENS AS TOBACCO SMOKE.”</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The owner or person in charge shall ensure that a sign required under this regulation is conspicuously posted and in good condition.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Complaints and Investigations."> <paragraph num="A."> <text>A person may register a complaint of a violation of a requirement of this chapter by means of:</text> <paragraph num="(1)"> <text>A written complaint to the health officer in the jurisdiction where the alleged violation took place; or</text> </paragraph> <paragraph num="(2)"> <text>A telephone complaint to the health officer in the jurisdiction where the alleged violation took place.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall make available a complaint form at the Department's website and at a local health department.</text> </paragraph> <paragraph num="C."> <text>Upon receipt of a complaint, the health officer or the health officer's designee shall:</text> <paragraph num="(1)"> <text>Record the complaint on the complaint form; and</text> </paragraph> <paragraph num="(2)"> <text>Investigate the complaint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Enforcement."> <paragraph num="A."> <text>A health officer or the health officer's designee may investigate conditions relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="B."> <text>The person in charge of an establishment shall permit a health officer or health officer's designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter.</text> </paragraph> <paragraph num="C."> <text>When an investigation is made, the health officer or the health officer's designee shall:</text> <paragraph num="(1)"> <text>Document:</text> <paragraph num="(a)"> <text>The result of the investigation on a report form provided by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>A condition found that is in violation of the provisions of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Furnish one copy of the report form to the person in charge of the establishment; and</text> </paragraph> <paragraph num="(3)"> <text>Make the completed report form available for public disclosure in accordance with State Government Article, §10-611— 10-628, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Violations and Certification of Correction."> <paragraph num="A."> <text>The health officer or the health officer's designee shall notify the owner of an establishment found in violation of a provision of this chapter or the Act:</text> <paragraph num="(1)"> <text>By certified mail, return receipt requested, bearing a postmark from the United States Postal Service;</text> </paragraph> <paragraph num="(2)"> <text>Of the specific finding and the penalty for the violation as set forth in Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Of a specific date by which the owner shall correct the violation;</text> </paragraph> <paragraph num="(4)"> <text>That if the owner fails to correct the violation by the date specified, or is in violation of another provision of this chapter or the Act at another time, the Secretary may impose a subsequent penalty as set forth in Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>That the owner is entitled to request a hearing under Regulation .11 of this chapter on a violation and penalty, as set forth in Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The owner of an establishment shall submit to the health officer a certification of correction within a time frame provided by the local health department that:</text> <paragraph num="(1)"> <text>Lists a violation; and</text> </paragraph> <paragraph num="(2)"> <text>Includes a description of how the correction was accomplished.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Penalties."> <paragraph num="A."> <text>A person who violates a provision of this chapter is subject to the following penalties:</text> <paragraph num="(1)"> <text>A written reprimand by the Secretary for the first violation;</text> </paragraph> <paragraph num="(2)"> <text>A civil penalty of $100 for a second violation;</text> </paragraph> <paragraph num="(3)"> <text>A civil penalty of $500 for the third violation; and</text> </paragraph> <paragraph num="(4)"> <text>A civil penalty of $1,000 per violation for each subsequent finding of violation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall pay a penalty collected under this regulation to the Cigarette Restitution Fund established under State Finance and Procurement Article, §7-317, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Request for Hearing."> <paragraph num="A."> <text>In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty.</text> </paragraph> <paragraph num="B."> <text>In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Schedule and conduct the hearing on the violation; and</text> </paragraph> <paragraph num="(2)"> <text>Render a decision and notify the parties of the decision within 30 days after the hearing.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-205 and 24-501 — 24-511, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 21, 1978 (5:8 Md. R. 594)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02W-1 adopted as an emergency provision effective March 26, 1979 (6:7 Md. R. 575); adopted permanently effective June 29, 1979 (6:13 Md. R. 1128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02PP amended as an emergency provision effective September 11, 1978 (5:9 Md. R. 1442), expired January 20, 1979; adopted permanently effective February 26, 1979 (6:4 Md. R. 277)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02QQQ amended as an emergency provision effective April 27, 1979 (6:10 Md. R. 839) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 16, 1980 (7:10 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 23, 1981 (8:23 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Drug Formulary of Equivalent Drug Products, repealed effective May 16, 1988 (15:10 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Tobacco Smoking in Retail Stores, adopted effective February 4, 1991 (18:2 Md. R. 149)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Tobacco Smoking in Retail Stores, repealed, and new Chapter, Prohibition of Smoking in Indoor Areas Open to the Public, adopted effective February 1, 2008 (34:26 Md. R. 2262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, D, F amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed effective February 16, 2026 (53:3 Md. R. 122)</annotation> </annotations> </chapter> <chapter num="05" heading="Flammable Articles"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>Except for the changes shown in Regulation .02 of this chapter, all provisions of 16 CFR 1602, 1605, 1608, 1609, 1610, 1611, 1615, 1616, and 1632, are incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In the incorporation by reference cited in Regulation .01 of this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means the Maryland Flammable Products Act, Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 30, 1978 (5:13 Md. R. 1063)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended and recodified to Regulations .01 and .02 effective October 23, 1995 (22:21 Md. R. 1616)</annotation> </annotations> </chapter> <chapter num="06" heading="Poison Prevention Packaging"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference of Poison Prevention Packaging Regulations."> <paragraph num="A."> <text>All provisions of 16 Code of Federal Regulations, Part 1700, are incorporated by reference, except for the changes shown in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>Definitions (see 16 CFR 1700, §1700.1).</text> <paragraph num="(1)"> <text>“Act” means Child Resistant Packaging of Dangerous Household Substances, Health-General Article, §§22-301 — 22-312, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Dietary supplement” means a vitamin or mineral preparation, or both, offered in tablet, capsule, wafer, or other similar uniform unit form; in powder, granule, flake, or liquid form; or in the physical form of a conventional food but which is not a conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins or minerals, or both.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 3, 1978 (5:22 Md. R. 1673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 7, 1991 (17:26 Md. R. 2975)</annotation> </annotations> </chapter> <chapter num="07" heading="Prohibition of Child Care Products Containing TCEP or TDCPP"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes regulations that prohibit the import, sale, or offering for sale of child care products containing:</text> <paragraph num="(1)"> <text>TCEP, also known as (tris (2-chloroethyl) phosphate); or</text> </paragraph> <paragraph num="(2)"> <text>TDCPP, also known as (tris (1, 3-dichloro-2-propyl) phosphate).</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter does not apply to the sale or distribution of a child care product that is resold, offered for resale, or distributed by a consumer for consumer use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Child care product” means a consumer product intended for use by a child under the age of 3 years, including a:</text> <paragraph num="(a)"> <text>Baby product;</text> </paragraph> <paragraph num="(b)"> <text>Toy;</text> </paragraph> <paragraph num="(c)"> <text>Car seat;</text> </paragraph> <paragraph num="(d)"> <text>Nursing pillow;</text> </paragraph> <paragraph num="(e)"> <text>Crib mattress; and</text> </paragraph> <paragraph num="(f)"> <text>Stroller.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(3)"> <text>“TCEP” means an industrial chemical also known as (tris (2-chloroethyl) phosphate).</text> </paragraph> <paragraph num="(4)"> <text>“TDCPP” means an industrial chemical also known as (tris (1, 3-dichloro-2-propyl) phosphate).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibition of TCEP or TDCPP in Child Care Products."> <paragraph num="A."> <text>A person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TCEP by mass.</text> </paragraph> <paragraph num="B."> <text>On or after October 1, 2014, a person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TDCPP by mass.</text> </paragraph> <paragraph num="C."> <text>The Secretary may suspend implementation of this chapter if the Secretary determines that the fire safety benefits of TCEP or TDCPP are greater than the known health risks associated with TCEP or TDCPP.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Violations."> <paragraph num="A."> <text>A person that violates this chapter is subject to:</text> <paragraph num="(1)"> <text>For a first violation, a civil penalty not exceeding $1,000; and</text> </paragraph> <paragraph num="(2)"> <text>For any subsequent violation, a civil penalty not exceeding $2,500 for each violation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the civil penalties described in §A of this regulation, a court may also enjoin an action prohibited in Regulation .04 of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-306 and 24-306.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective January 19, 2015 (42:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 19, 2015 (42:1 Md. R. 18); December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 19, 2015 (42:1 Md. R. 18)</annotation> </annotations> </chapter> <chapter num="08" heading="Prohibition of Consumer Products Containing Flame-Retardant Chemicals"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes regulations that prohibit the import, sale, or offering for sale of juvenile products, mattresses, upholstered furniture, or reupholstered furniture containing more than 0.1 percent of flame-retardant chemical by mass.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to the sale or distribution of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture that is resold, offered for resale, or distributed by a consumer for consumer use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adult mattress” means any mattress other than a toddler mattress, a crib mattress, or any other infant sleep product.</text> </paragraph> <paragraph num="(2)"> <text>“Flame-retardant chemical” means a chemical that:</text> <paragraph num="(a)"> <text>Is used to resist or inhibit the spread of fire or act as a synergist to chemicals that resist or inhibit the spread of fire, including any chemical for which the term “flame retardant” appears on a safety data sheet developed in accordance with 29 CFR §1910.1200(g); and</text> </paragraph> <paragraph num="(b)"> <text>Is a nanoscale chemical or has one or more of the following properties:</text> <paragraph num="(i)"> <text>Contains one or more halogen elements, including fluorine, chlorine, bromine, or iodine;</text> </paragraph> <paragraph num="(ii)"> <text>Contains one or more carbon elements and one or more phosphorus elements; and</text> </paragraph> <paragraph num="(iii)"> <text>Contains one or more carbon elements and one or more nitrogen elements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Juvenile Product.</text> <paragraph num="(a)"> <text>“Juvenile product” means a consumer product intended for use by a child younger than 12 years old.</text> </paragraph> <paragraph num="(b)"> <text>“Juvenile product” includes:</text> <paragraph num="(i)"> <text>A bassinet;</text> </paragraph> <paragraph num="(ii)"> <text>A booster seat;</text> </paragraph> <paragraph num="(iii)"> <text>A changing pad;</text> </paragraph> <paragraph num="(iv)"> <text>A children’s nap mat;</text> </paragraph> <paragraph num="(v)"> <text>A floor playmat;</text> </paragraph> <paragraph num="(vi)"> <text>A high chair;</text> </paragraph> <paragraph num="(vii)"> <text>A high chair pad;</text> </paragraph> <paragraph num="(viii)"> <text>An infant bouncer;</text> </paragraph> <paragraph num="(ix)"> <text>An infant carrier;</text> </paragraph> <paragraph num="(x)"> <text>An infant seat;</text> </paragraph> <paragraph num="(xi)"> <text>An infant swing;</text> </paragraph> <paragraph num="(xii)"> <text>An infant walker;</text> </paragraph> <paragraph num="(xiii)"> <text>A nursing pad;</text> </paragraph> <paragraph num="(xiv)"> <text>A nursing pillow;</text> </paragraph> <paragraph num="(xv)"> <text>A playpen side pad;</text> </paragraph> <paragraph num="(xvi)"> <text>A play yard;</text> </paragraph> <paragraph num="(xvii)"> <text>A portable hook-on chair; and</text> </paragraph> <paragraph num="(xviii)"> <text>A stroller.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Juvenile product” does not include a:</text> <paragraph num="(i)"> <text>Product that is not primarily intended for use in the home, including a product that is, or is a component part of, a motor vehicle, a watercraft, an aircraft, or any other vehicle;</text> </paragraph> <paragraph num="(ii)"> <text>Product regulated under 49 CFR Part 571;</text> </paragraph> <paragraph num="(iii)"> <text>Consumer electronic product; or</text> </paragraph> <paragraph num="(iv)"> <text>Child care product regulated under Health-General Article, §24-306, Annotated Code of Maryland, or COMAR 10.19.07.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Mattress” has the meaning stated in 16 CFR § 1632.1.</text> </paragraph> <paragraph num="(5)"> <text>“Reupholstered furniture” means furniture for which the original fabric, padding, decking, barrier material, foam, or other resilient filling has been replaced and that has not been sold since the time of replacement.</text> </paragraph> <paragraph num="(6)"> <text>“Upholstered furniture” means furniture that includes filling materials, barrier materials, decking materials, or cover fabrics.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibition of Flame-Retardant Chemicals in Consumer Products."> <paragraph num="A."> <text>This regulation does not apply to:</text> <paragraph num="(1)"> <text>An electronic component, or the casing for an electronic component, of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture;</text> </paragraph> <paragraph num="(2)"> <text>A component of upholstered or reupholstered furniture other than cover fabric, barrier material, resilient filling material, and decking material;</text> </paragraph> <paragraph num="(3)"> <text>Thread or fiber when used for stitching mattress components together; or</text> </paragraph> <paragraph num="(4)"> <text>Except for foam, a component of an adult mattress.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person may not import, sell, or offer for sale any juvenile product, mattress, upholstered furniture, or reupholstered furniture that contains more than 0.1 percent of flame-retardant chemicals by mass.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Complaints and Investigations."> <paragraph num="A."> <text>The Secretary or the Secretary’s designee may investigate conditions relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="B."> <text>The person in charge of an establishment shall permit the Secretary or the Secretary’s designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter.</text> </paragraph> <paragraph num="C."> <text>The person in charge of an establishment shall provide to the Secretary or the Secretary’s designee product safety data sheets, technical specifications, and any information available related to the composition of the juvenile product.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Violations."> <paragraph num="A."> <text>If a person willfully violates this chapter, the Secretary may assess a civil penalty:</text> <paragraph num="(1)"> <text>For a first violation after receiving a letter of reprimand, not exceeding $2,500;</text> </paragraph> <paragraph num="(2)"> <text>For a second violation, not exceeding $5,000;</text> </paragraph> <paragraph num="(3)"> <text>For a third violation, not exceeding $7,500; and</text> </paragraph> <paragraph num="(4)"> <text>For any subsequent violation, not exceeding $10,000 for each violation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining the amount of a penalty under §A of this regulation, the Secretary shall consider:</text> <paragraph num="(1)"> <text>The nature and severity of the violation;</text> </paragraph> <paragraph num="(2)"> <text>The good faith of the person;</text> </paragraph> <paragraph num="(3)"> <text>The history of violations by the person;</text> </paragraph> <paragraph num="(4)"> <text>The extent to which the person cooperated with any investigation by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Whether the person has previously been issued a letter of reprimand.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For a violation of this chapter, the Secretary shall issue a letter of reprimand.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Request for Hearing."> <paragraph num="A."> <text>In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty.</text> </paragraph> <paragraph num="B."> <text>In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Schedule and conduct the hearing on the violation; and</text> </paragraph> <paragraph num="(2)"> <text>Render a decision and notify the parties of the decision within 30 days after the hearing.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24-306.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 25, 2023 (50:25 Md. R. 1088)</annotation> </annotations> </chapter> </subtitle> <subtitle num="20" heading="Kidney Disease Program"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has applied for, or is in the process of applying for, Kidney Disease Program enrollment and has not yet been certified as an eligible recipient.</text> </paragraph> <paragraph num="(2)"> <text>“Certification period” means the 12-month period during which an individual is certified as eligible to receive Kidney Disease Program benefits.</text> </paragraph> <paragraph num="(3)"> <text>“Certified facility” means a hospital, dialysis facility, or transplantation center which the Department certifies meets the standards that the Commission adopts for providing services to recipients and which is certified by Medicare.</text> </paragraph> <paragraph num="(4)"> <text>“Commission” means the State Commission on Kidney Disease.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Dialysis” means chronic hemodialysis or chronic peritoneal dialysis provided in a certified facility or a facility approved by the Commission or in the patient's home under the auspices of a certified facility or home dialysis program approved by the Commission.</text> </paragraph> <paragraph num="(7)"> <text>“End stage renal disease (ESRD)” means that stage of renal impairment that appears irreversible and permanent, and requires a regular course of maintenance dialysis or kidney transplantation to maintain life.</text> </paragraph> <paragraph num="(8)"> <text>“Family” means the recipient and all of the following individuals sharing the same household with the recipient:</text> <paragraph num="(a)"> <text>The recipient's spouse;</text> </paragraph> <paragraph num="(b)"> <text>The recipient's natural or adopted children who are younger than 21 years old;</text> </paragraph> <paragraph num="(c)"> <text>The recipient's natural or adoptive parent, if the recipient is a child younger than 21 years old; and</text> </paragraph> <paragraph num="(d)"> <text>The recipient's stepchildren or grandchildren for which the recipient has legal or presumed guardianship.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Liquid assets” means cash or an asset that can readily be converted to cash.</text> </paragraph> <paragraph num="(10)"> <text>“Medical Assistance” means the State program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(11)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.</text> </paragraph> <paragraph num="(12)"> <text>“Poverty income guidelines” means the federal poverty income guidelines contained in the most recent annual update of the Department of Health and Human Services poverty income guidelines as published in the Federal Register.</text> </paragraph> <paragraph num="(13)"> <text>“Preauthorization” means an approval required from the Program before services are rendered to a recipient.</text> </paragraph> <paragraph num="(14)"> <text>“Primary Adult Care Program (PAC)” has the meaning stated in COMAR 10.09.60.02.</text> </paragraph> <paragraph num="(15)"> <text>“Program” means the Kidney Disease Program of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Program participation fee” means an annual premium which may be assessed by the Program and is based on family income or liquid assets, or both.</text> </paragraph> <paragraph num="(17)"> <text>“Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or certified to provide health care services for Program recipients.</text> </paragraph> <paragraph num="(18)"> <text>“Qualified alien” means an alien who:</text> <paragraph num="(a)"> <text>Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA);</text> </paragraph> <paragraph num="(b)"> <text>Has been granted asylum in the United States under §208 of the INA;</text> </paragraph> <paragraph num="(c)"> <text>Has been admitted into the United States as a refugee under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year;</text> </paragraph> <paragraph num="(e)"> <text>Has had deportation withheld under §243(h) of the INA; or</text> </paragraph> <paragraph num="(f)"> <text>Has been granted conditional entry into the United States under §203(a)(7) of the INA in effect before April 1, 1980.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Quarterly amount” means the quarterly installment payment which is equal to 25 percent of a recipient's annual Program participation fee.</text> </paragraph> <paragraph num="(20)"> <text>“Recipient” means an individual who is certified for enrollment in the Kidney Disease Program of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Reimbursable drug list” means the Kidney Disease Program formulary of medications approved for payment.</text> </paragraph> <paragraph num="(22)"> <text>“Representative” means an individual who, because of an applicant's or a recipient's mental or physical incapacity or youth, or specified dialysis or transplant facility personnel who have been so designated by virtue of the applicant's or recipient's voluntarily signed authorization form, is authorized, in accordance with State law, to complete, sign, or withdraw an application for enrollment in the Program or to activate a hearing process.</text> </paragraph> <paragraph num="(23)"> <text>Resident.</text> <paragraph num="(a)"> <text>“Resident” means an individual permanently living in Maryland whose temporary absence from the State does not interrupt continuity of residence.</text> </paragraph> <paragraph num="(b)"> <text>“Resident” does not mean:</text> <paragraph num="(i)"> <text>Members or their families, or both, of the United States armed services temporarily stationed in Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Foreign nationals employed in embassies of their native country.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Program Application Process."> <paragraph num="A."> <text>A Maryland resident diagnosed with end-stage renal disease may apply for certification with the Program.</text> </paragraph> <paragraph num="B."> <text>An applicant, or the applicant's representative, shall complete a written application on the form designated by the Program.</text> </paragraph> <paragraph num="C."> <text>Application Supporting Documents.</text> <paragraph num="(1)"> <text>The Program may require the following as part of the application form or in addition to the application form:</text> <paragraph num="(a)"> <text>Copies of the previous year's federal income tax return of the applicant and each individual in the applicant's family;</text> </paragraph> <paragraph num="(b)"> <text>Current statements of liquid assets owned by the applicant and each individual in the applicant's family;</text> </paragraph> <paragraph num="(c)"> <text>The amount of the current Social Security benefits and all retirement or pension benefits, or both, of the applicant and each individual in the applicant's family;</text> </paragraph> <paragraph num="(d)"> <text>Documentation of the applicant’s identity as well as citizenship or nationality, to the Department’s satisfaction, based on federal requirements;</text> </paragraph> <paragraph num="(e)"> <text>Verification of the applicant's status as a resident of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>Verification of the applicant’s Medicare status;</text> </paragraph> <paragraph num="(g)"> <text>Verification concerning the applicant's enrollment in any health insurance benefit plan;</text> </paragraph> <paragraph num="(h)"> <text>Physician's certification that the applicant has ESRD;</text> </paragraph> <paragraph num="(i)"> <text>Physician's certification that the applicant has begun a regular course of maintenance renal dialysis in a certified facility or received a renal transplant, or both;</text> </paragraph> <paragraph num="(j)"> <text>A signed statement authorizing the Program to verify, from any source including banks, insurance companies, and public or private agencies providing monetary benefits, information submitted to the Program by the applicant; and</text> </paragraph> <paragraph num="(k)"> <text>Other information the Program determines is needed to establish whether the applicant is eligible to be a recipient.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Refusal to sign an authorization that may be required under §C(1)(j) of this regulation is considered failure to provide sufficient information, and the applicant will be determined ineligible without prejudice in accordance with §F of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>In reference to §C(1)(a) of this regulation, the Program may accept the previous year's tax return through April 15 of the year in which an application for certification is filed. After April 15, the Program requires the new tax return or proof of extension granted for filing a return.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Signature Requirements.</text> <paragraph num="(1)"> <text>For the purpose of establishing eligibility, the applicant or the applicant's representative, as appropriate, shall complete and sign the application form.</text> </paragraph> <paragraph num="(2)"> <text>A physician shall sign the certification that the applicant has ESRD and has begun a regular course of maintenance renal dialysis, or has received a renal transplant, or both.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The applicant or the applicant's representative shall forward the completed application form and supporting documents to the address designated on the form.</text> </paragraph> <paragraph num="F."> <text>An applicant shall provide all required information within 90 days from the date the information is originally requested by the Program or the applicant shall be determined ineligible without prejudice and may reapply.</text> </paragraph> <paragraph num="G."> <text>The applicant, or the applicant's representative, may voluntarily withdraw an application at any time without prejudice.</text> </paragraph> <paragraph num="H."> <text>If the Program determines that an applicant is not eligible for Program enrollment, the Program shall notify the applicant or the applicant's representative, as appropriate, in writing within 45 days of receipt of a completed application and include the following in the notice:</text> <paragraph num="(1)"> <text>The basis for the determination of ineligibility;</text> </paragraph> <paragraph num="(2)"> <text>An explanation of the right to request a hearing; and</text> </paragraph> <paragraph num="(3)"> <text>A statement that the applicant is permitted to submit a new application for Program enrollment at any time.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the Program determines that an applicant is eligible for Program enrollment, the Program shall:</text> <paragraph num="(1)"> <text>Establish a certification period in accordance with Regulation .03C of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Notify the applicant or the applicant's representative, as appropriate, in writing within 45 days of receipt of a completed application;</text> </paragraph> <paragraph num="(3)"> <text>Issue a Kidney Disease Program recipient identification card and instructions for using the card; and</text> </paragraph> <paragraph num="(4)"> <text>Notify the applicant or the applicant's representative, as appropriate, about any Program participation fee due in accordance with Regulation .04 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Recipient Eligibility and Certification for Program Participation."> <paragraph num="A."> <text>To be eligible for enrollment in the Program an applicant shall:</text> <paragraph num="(1)"> <text>Be a resident of Maryland and one of the following:</text> <paragraph num="(a)"> <text>A citizen of the United States,</text> </paragraph> <paragraph num="(b)"> <text>A qualified alien, as specified in §C of this regulation, who is eligible in accordance with the requirements related to the 5-year bar specified at §D of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>An alien who is:</text> <paragraph num="(i)"> <text>Eligible for and receiving Supplemental Security Income (SSI);</text> </paragraph> <paragraph num="(ii)"> <text>A member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or</text> </paragraph> <paragraph num="(iii)"> <text>An American Indian born in Canada to whom §289 of the Immigration and Nationality Act (INA) applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be certified by a physician as having end stage renal disease;</text> </paragraph> <paragraph num="(3)"> <text>Meet one of the following requirements:</text> <paragraph num="(a)"> <text>Have begun a regular course of maintenance renal dialysis in a certified facility or have received a renal transplant, or both; or</text> </paragraph> <paragraph num="(b)"> <text>Have begun a course of maintenance renal dialysis in an out-of-State facility when the Program has preauthorized the treatment based on the facility's proximity to the applicant's residence or to assure continuity of care, or both; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submit an application in accordance with Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual detained by a federal, state, or local penal or correctional system as a result of a charge, indictment, or conviction of a criminal offense is not eligible for Program enrollment.</text> </paragraph> <paragraph num="C."> <text>Qualified Aliens. According to §431 of the Personal Responsibility and Work Opportunity and Reconciliation Act of 1996 (PRWORA), qualified aliens admitted to the United States shall include:</text> <paragraph num="(1)"> <text>The following types of aliens, who may be subject to the 5-year bar specified at §D of this regulation, depending on their most recent date of entry and their date of qualified alien status:</text> <paragraph num="(a)"> <text>Aliens who were lawfully admitted to the United States for permanent residence or who since admission were granted lawful permanent resident status in accordance with the INA;</text> </paragraph> <paragraph num="(b)"> <text>Aliens granted parole for at least 1 year under §212(d)(5) of the INA; and</text> </paragraph> <paragraph num="(c)"> <text>A documented or undocumented immigrant who was battered or subjected to extreme cruelty by the individual’s United States citizen or lawful permanent resident spouse or parent, or by a member of the spouse’s or parent’s family residing in the same household as the immigrant, if:</text> <paragraph num="(i)"> <text>The spouse or parent consented to, or acquiesced in, the battery or cruelty;</text> </paragraph> <paragraph num="(ii)"> <text>The abusive act or acts occurred in the United States;</text> </paragraph> <paragraph num="(iii)"> <text>The individual responsible for the battery or cruelty no longer lives in the same household as the victim;</text> </paragraph> <paragraph num="(iv)"> <text>A Violence Against Women Act immigration case or a family-based visa petition has been filed; and</text> </paragraph> <paragraph num="(v)"> <text>There is a substantial connection between the battery or cruelty and the need for Medical Assistance benefits; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following types of aliens, who are not subject to the 5-year bar specified in §D of this regulation:</text> <paragraph num="(a)"> <text>Alien children and pregnant women who are lawfully residing in the United States, including legal permanent residents who have resided in the United States for less than 5 years as described under §214 of the Children’s Health Insurance Program Authorization Act of 2009 (CHIPRA);</text> </paragraph> <paragraph num="(b)"> <text>Aliens who were lawfully admitted to the United States for permanent residence as Amerasian immigrants under §584 of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1988;</text> </paragraph> <paragraph num="(c)"> <text>Refugees admitted under §207 of the INA;</text> </paragraph> <paragraph num="(d)"> <text>Aliens granted asylum under §208 of the INA;</text> </paragraph> <paragraph num="(e)"> <text>Aliens whose deportation is being withheld under:</text> <paragraph num="(i)"> <text>§243(h) of the INA as in effect prior to April 1, 1997; or</text> </paragraph> <paragraph num="(ii)"> <text>§241(b)(3) of the INA, as amended;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Cuban or Haitian entrants, as defined at §501(e) of the Refugee Education Assistance Act of 1980;</text> </paragraph> <paragraph num="(g)"> <text>Aliens granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980;</text> </paragraph> <paragraph num="(h)"> <text>Children receiving federal payments for foster care or adoption assistance under Part B or E of Title IV of the Social Security Act, if the child’s foster or adoptive parent is considered a citizen or qualified alien; and</text> </paragraph> <paragraph num="(i)"> <text>Victims of a severe form of trafficking, in accordance with §107(b)(1) of the Trafficking Victims Protection Act of 2000, who have been subjected to:</text> <paragraph num="(i)"> <text>Sex trafficking if the act is induced by force, fraud, or coercion, or the individual who was induced to perform the act was younger than 18 years old on the date that the visa application was filed; or</text> </paragraph> <paragraph num="(ii)"> <text>Involuntary servitude.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Five-Year Bar to Program Benefits for Qualified Aliens.</text> <paragraph num="(1)"> <text>Qualified aliens in the categories specified in §C(1) of this regulation who entered the United States on or after August 22, 1996, were not eligible for Program benefits for 5 years from the date that the qualified alien:</text> <paragraph num="(a)"> <text>Entered the United States with the status of a qualified alien; or</text> </paragraph> <paragraph num="(b)"> <text>Obtained the status of a qualified alien, if the individual did not enter the United States as a qualified alien.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The 5-year bar specified in §D(1) of this regulation shall also be applied to qualified aliens who entered the United States before August 22, 1996, but did not remain continuously present in the United States from the last date of entry before August 22, 1996 until the date of qualified alien status.</text> </paragraph> <paragraph num="(3)"> <text>An alien is not considered to be continuously present in the United States as specified in §D(2) of this regulation if, before the date of qualified alien status, the alien had:</text> <paragraph num="(a)"> <text>A single absence from the United States of more than 30 days; or</text> </paragraph> <paragraph num="(b)"> <text>Absences from the United States totaling more than 90 days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The 5-year bar to eligibility for Program benefits, specified in §D(1) of this regulation, does not apply to:</text> <paragraph num="(a)"> <text>Qualified aliens in the categories specified at:</text> <paragraph num="(i)"> <text>§C(1) of this regulation, who are not subject to the 5-year bar in accordance with §D(1) or (2) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>§C(2) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A qualified alien who is:</text> <paragraph num="(i)"> <text>An honorably discharged veteran of the armed forces of the United States;</text> </paragraph> <paragraph num="(ii)"> <text>On active duty in the armed forces of the United States; or</text> </paragraph> <paragraph num="(iii)"> <text>The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an honorably discharged veteran or individual on active duty in the armed forces of the United States; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Lawful permanent residents who:</text> <paragraph num="(i)"> <text>Entered the United States under another exempt category specified at §D(4)(a) — (b) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Converted to lawful permanent resident status.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Certification Period.</text> <paragraph num="(1)"> <text>The Program shall establish the certification period during which an individual is eligible to receive Program benefits.</text> </paragraph> <paragraph num="(2)"> <text>The certification period shall be retroactive to the first day of maintenance renal dialysis or renal transplantation if a completed application is received by the Program within 30 days after the first day of maintenance renal dialysis, or within 30 days after renal transplantation, whichever treatment occurs first.</text> </paragraph> <paragraph num="(3)"> <text>If a completed application is received by the Program more than 30 days after the first day of maintenance renal dialysis, or more than 30 days after the date of renal transplantation, whichever treatment occurs first, the certification period shall begin on the first day of the month in which the completed application is received by the Program.</text> </paragraph> <paragraph num="(4)"> <text>The Program shall certify a recipient for a 12-month period.</text> </paragraph> <paragraph num="(5)"> <text>The Program shall promptly redetermine eligibility when it receives information concerning a recipient's circumstances that may affect continuing eligibility.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A recipient shall comply with the following requirements to continue Program enrollment throughout a certification period:</text> <paragraph num="(1)"> <text>Unless a recipient can document continuing insurance coverage that is equal to or greater than Medicare benefits, apply for enrollment in Part A, Part B, and Part D of Medicare within 60 days of notification to do so by the Program, if not already a Medicare beneficiary;</text> </paragraph> <paragraph num="(2)"> <text>Apply for enrollment in Part A, Part B, and Part D of Medicare within 60 days following termination of insurance coverage that is equal to or greater than Medicare benefits;</text> </paragraph> <paragraph num="(3)"> <text>Maintain enrollment in Part A, Part B, and Part D of Medicare if eligible;</text> </paragraph> <paragraph num="(4)"> <text>Apply for enrollment in Medical Assistance within 60 days of notification to do so by the Program;</text> </paragraph> <paragraph num="(5)"> <text>Maintain enrollment in Medical Assistance if eligible;</text> </paragraph> <paragraph num="(6)"> <text>Continue to meet the requirements of §§A and I of this regulation;</text> </paragraph> <paragraph num="(7)"> <text>Reimburse the Department any monies received from any insurance company or other third party for payment of ESRD treatment costs previously reimbursed by the Program; and</text> </paragraph> <paragraph num="(8)"> <text>Pay the Program participation fee, if applicable, in accordance with Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A recipient is considered to have failed to meet the requirement of §F(4) of this regulation if:</text> <paragraph num="(1)"> <text>The recipient fails to provide information required for certification or recertification of Medical Assistance eligibility; or</text> </paragraph> <paragraph num="(2)"> <text>Medical Assistance disenrolls the recipient because of recipient fraud, recipient abuse, or recipient failure to comply with reporting requirements.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reapplication for Continuation of Certification.</text> <paragraph num="(1)"> <text>The Program shall notify the recipient in writing 60 days before an annual certification period expires.</text> </paragraph> <paragraph num="(2)"> <text>A recipient shall complete a written application for continuation of certification for Program benefits.</text> </paragraph> <paragraph num="(3)"> <text>A recipient shall be disenrolled from the Program upon expiration of a certification period unless the Program receives a completed application for continuation of certification 30 days before expiration of a certification period.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The recipient shall notify the Program within 30 working days of:</text> <paragraph num="(1)"> <text>A payment received from any source that is related to treatment of the recipient's ESRD;</text> </paragraph> <paragraph num="(2)"> <text>The recipient's regaining renal function;</text> </paragraph> <paragraph num="(3)"> <text>A change in address; or</text> </paragraph> <paragraph num="(4)"> <text>A change in State residence, citizenship, or alien status.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Termination Before Expiration of Certification Period.</text> <paragraph num="(1)"> <text>The Program shall terminate a recipient’s enrollment in the Program before expiration of the current certification period if the recipient:</text> <paragraph num="(a)"> <text>Fails to provide the notice required by §I of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Voluntarily disenrolls;</text> </paragraph> <paragraph num="(c)"> <text>No longer meets the medical requirements for participation;</text> </paragraph> <paragraph num="(d)"> <text>No longer meets the residence, citizenship, or alien status requirements of §A(1) of this regulation;</text> </paragraph> <paragraph num="(e)"> <text>Fails to pay the Program participation fee described in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Fails to apply for and maintain enrollment in Medicare, if eligible;</text> </paragraph> <paragraph num="(g)"> <text>Fails to apply for and maintain enrollment in the Medical Assistance Program if required by the Program;</text> </paragraph> <paragraph num="(h)"> <text>Fails to pay the Department any monies received from any source for payment of ESRD treatment costs previously reimbursed by the Program;</text> </paragraph> <paragraph num="(i)"> <text>Has not received a kidney transplant but no longer requires a regular course of maintenance dialysis, 12 months after the date on which the course of dialysis is terminated;</text> </paragraph> <paragraph num="(j)"> <text>Is incarcerated by a federal, state, or local penal or correctional system;</text> </paragraph> <paragraph num="(k)"> <text>Has used the Program identification number to fraudulently obtain goods or services, or permits another individual to use the Program identification number to fraudulently obtain goods or services;</text> </paragraph> <paragraph num="(l)"> <text>Fails to pay the quarterly amount within the required time frame and the Program has not paid for any services provided for the recipient within the quarter; or</text> </paragraph> <paragraph num="(m)"> <text>Has died.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pursuant to §J(1)(l) of this regulation, termination is considered voluntary withdrawal and becomes effective retroactive to the first day of the quarter billed.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Continuing Certification and Termination Notices.</text> <paragraph num="(1)"> <text>The Program shall inform a recipient, or the recipient's representative, of the recipient's rights and obligations regarding continuing certification and termination of Program enrollment.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall give the recipient or the recipient’s representative written notification of the following:</text> <paragraph num="(a)"> <text>That a certification period is due to expire and reapplication is required as set forth in §H of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The effective date of termination of Program enrollment when:</text> <paragraph num="(i)"> <text>The recipient no longer meets the residence, citizenship, or alien status requirements;</text> </paragraph> <paragraph num="(ii)"> <text>The recipient is incarcerated; or</text> </paragraph> <paragraph num="(iii)"> <text>The recipient has died; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Program’s intent to terminate the recipient’s enrollment for reasons other than those set forth in §K(2)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A notice that the certification period is about to expire or of the Program's intent to terminate the recipient's enrollment due to the recipient's failure to apply for recertification or to pay the assessed quarterly premium shall:</text> <paragraph num="(a)"> <text>Be mailed at least 30 calendar days before the date on which the action is to be effective;</text> </paragraph> <paragraph num="(b)"> <text>Include a statement of the proposed actions, the reasons for the action, and the regulatory citation supporting the action; and</text> </paragraph> <paragraph num="(c)"> <text>Include an explanation of the right to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>If the Program determines that the recipient has used the Program identification number to fraudulently obtain goods or services, or has permitted another individual to use the Program identification number to fraudulently obtain goods or services, and certification is terminated pursuant to §J(1)(k) of this regulation, the recipient is not eligible to reapply for Program certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Participation Fee."> <paragraph num="A."> <text>A recipient whose family income exceeds 175 percent of the poverty income guidelines or whose family liquid assets exceed 200 percent of the poverty income guidelines, or both, at the time of initial application or reapplication is required to pay an annual Program participation fee.</text> </paragraph> <paragraph num="B."> <text>Family income for purposes of this regulation includes the adjusted gross income, as defined in the Internal Revenue Code for federal income tax purposes, plus Social Security benefits, all pension or retirement benefits, or both, and all interest income not otherwise included in the adjusted gross income for federal income tax purposes, of the recipient and each person in the recipient's family.</text> </paragraph> <paragraph num="C."> <text>The Program shall establish a recipient's annual Program payment fee equal to the sum of:</text> <paragraph num="(1)"> <text>5 percent of the amount by which the family income exceeds 175 percent of the poverty income guidelines adjusted for family size; plus</text> </paragraph> <paragraph num="(2)"> <text>5 percent of the family's liquid assets above 200 percent of the poverty income guidelines adjusted for family size.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For purposes of §C(2) of this regulation, the Program shall:</text> <paragraph num="(1)"> <text>Include assets which are available as of the date of application for initial enrollment or certification of continuing enrollment, as applicable, in the family's liquid assets;</text> </paragraph> <paragraph num="(2)"> <text>Include the following in the family's liquid assets:</text> <paragraph num="(a)"> <text>Cash;</text> </paragraph> <paragraph num="(b)"> <text>Savings and checking accounts;</text> </paragraph> <paragraph num="(c)"> <text>Certificates of deposit;</text> </paragraph> <paragraph num="(d)"> <text>Stocks;</text> </paragraph> <paragraph num="(e)"> <text>Bonds;</text> </paragraph> <paragraph num="(f)"> <text>Life insurance cash value exceeding $1,500;</text> </paragraph> <paragraph num="(g)"> <text>Mutual funds;</text> </paragraph> <paragraph num="(h)"> <text>Money market certificates; and</text> </paragraph> <paragraph num="(i)"> <text>Other financial instruments or investments that can readily be converted to cash; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Exclude the following from the family's liquid assets:</text> <paragraph num="(a)"> <text>Items of real property; and</text> </paragraph> <paragraph num="(b)"> <text>Items of personal property.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Collection of Fees.</text> <paragraph num="(1)"> <text>The Department shall collect the annual Program participation fee in quarterly installments.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall notify the recipient of the amount of the annual Program participation fee, the quarterly amount to be paid, the payment due date, and payment procedures.</text> </paragraph> <paragraph num="(3)"> <text>The Program may revise the amount of the Program participation fee during a certification period if the Program determines that a revision should be made because of a change in:</text> <paragraph num="(a)"> <text>Family income;</text> </paragraph> <paragraph num="(b)"> <text>Family liquid assets; or</text> </paragraph> <paragraph num="(c)"> <text>Composition of the family unit.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The recipient shall have a grace period lasting from the first day of the quarter until 30 days before the end of the quarter in which to pay the quarterly amount.</text> </paragraph> <paragraph num="(5)"> <text>The recipient's enrollment in the Program shall be terminated on the last day of the quarter if a fee amount is not paid by the end of the grace period.</text> </paragraph> <paragraph num="(6)"> <text>The recipient is responsible for the assessed quarterly amount if the Program receives claims and makes payment for services provided for the recipient within the quarterly billing period.</text> </paragraph> <paragraph num="(7)"> <text>The Program shall extend the grace period for up to 6 months when the Program determines that, due to extraordinary medical expenses paid by the recipient, a change in family income, or frequent or extended hospitalizations, payment within the grace period will cause substantial hardship to the recipient.</text> </paragraph> <paragraph num="(8)"> <text>The Department may not refund the Program participation fee paid when the recipient’s Program enrollment is terminated unless termination occurs before the start of the quarter for which the Program participation fee was paid.</text> </paragraph> <paragraph num="(9)"> <text>Before the Program will recertify an applicant whose prior Program enrollment was terminated for failure to pay the Program participation fee in accordance with this regulation, the applicant shall:</text> <paragraph num="(a)"> <text>Pay any unpaid fees owing for all prior enrollment periods during which the applicant was enrolled in the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Make advance payment of the first quarterly installment of the Program participation fee established for the subsequent enrollment period.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Preauthorization."> <paragraph num="A."> <text>The following procedures or services require preauthorization:</text> <paragraph num="(1)"> <text>Treatment that is provided outside of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Pre-renal transplant dental services;</text> </paragraph> <paragraph num="(3)"> <text>Ancillary supplies for home intravenous antibiotic therapy;</text> </paragraph> <paragraph num="(4)"> <text>Durable medical equipment and disposable medical supplies used in the home; and</text> </paragraph> <paragraph num="(5)"> <text>One pair of eyeglasses, one time only.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program may preauthorize services when the provider submits to the Program adequate documentation demonstrating that the service to be preauthorized is directly related to treatment of the recipient's ESRD.</text> </paragraph> <paragraph num="C."> <text>Renal transplantation services provided to a recipient outside of Maryland are not eligible for reimbursement unless the Commission gives prior written approval for the transplant.</text> </paragraph> <paragraph num="D."> <text>The Program does not cover:</text> <paragraph num="(1)"> <text>Any service denied by Medicare as not medically justified or any services covered by Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>Services which are investigational or experimental.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In cases of multiple organ transplants, Program coverage shall be limited to only those services related to transplantation of the kidney. The provider shall break out and satisfactorily document the charges related to the kidney transplant before submitting a reimbursement request to the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="License Requirements."> <paragraph num="A."> <text>A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located.</text> </paragraph> <paragraph num="B."> <text>A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.</text> </paragraph> <paragraph num="C."> <text>A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery, and to dispense drugs in the state in which the service is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Provider Reimbursement."> <paragraph num="A."> <text>To qualify as a provider, a pharmacy shall:</text> <paragraph num="(1)"> <text>Maintain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located;</text> </paragraph> <paragraph num="(2)"> <text>To the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided; and</text> </paragraph> <paragraph num="(3)"> <text>Be a provider in the Maryland Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall reimburse for treatment directly related to a recipient's ESRD or a condition that is a direct result of the recipient's ESRD.</text> </paragraph> <paragraph num="C."> <text>The Program shall reimburse the incurred costs of prescription drugs and other pharmaceutical products determined to be medically necessary by the recipient's physician for treatment directly related to the recipient's ESRD or a condition that is a direct result of the recipient's ESRD.</text> </paragraph> <paragraph num="D."> <text>Before invoicing the Program, providers of Program-approved services shall first seek reimbursement from all other payment sources of the recipient including, but not limited to, insurance coverage, Medicare, Medical Assistance, and PAC. If the other sources reject a claim or pay less than the amount allowed by the Program, the provider may then submit the claim to the Program for review.</text> </paragraph> <paragraph num="E."> <text>A pharmacy provider may invoice the Program for reimbursement of legend drugs covered through the major medical component of a recipient's third-party insurance. The Program shall then seek reimbursement from the recipient's major medical coverage.</text> </paragraph> <paragraph num="F."> <text>When a recipient who is a Medicare beneficiary is provided a service that is covered by Medicare and the Program, Program payment shall be limited to payment of the recipient's Medicare deductible and co-insurance amounts.</text> </paragraph> <paragraph num="G."> <text>The Program may not reimburse for Medical Assistance covered services if the recipient is a Medical Assistance recipient.</text> </paragraph> <paragraph num="H."> <text>When a service is covered by a recipient's health insurance plan under which the provider agrees to accept payment by the health insurance plan as payment in full for the service, payment may not be made by the Program.</text> </paragraph> <paragraph num="I."> <text>The Program may not make a direct payment to a recipient.</text> </paragraph> <paragraph num="J."> <text>Program reimbursement for outpatient dialysis treatment shall be consistent with the limits established and rates paid by Medicare.</text> </paragraph> <paragraph num="K."> <text>Program reimbursement for other than outpatient dialysis treatment shall be consistent with the limits established and rates or fees paid by the Maryland Medical Assistance Program for the service except as otherwise indicated in this regulation. For services reimbursed on a fee basis, only the Medical Assistance net reimbursement amount will be paid.</text> </paragraph> <paragraph num="L."> <text>Reimbursement for preauthorized out-of-State renal transplantation services may not exceed rates paid for the same or similar services in Maryland.</text> </paragraph> <paragraph num="M."> <text>Program reimbursement for pharmacy services is as follows:</text> <paragraph num="(1)"> <text>The Program shall only pay for legend drugs and diabetic supplies itemized on the Kidney Disease Program of Maryland Reimbursable Drug List;</text> </paragraph> <paragraph num="(2)"> <text>A pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for legend drugs;</text> </paragraph> <paragraph num="(3)"> <text>Drugs shall be reimbursed by the Program as follows:</text> <paragraph num="(a)"> <text>Program payment for a legend drug shall be the lower of the provider's charge or the Medical Assistance allowable cost for the drug;</text> </paragraph> <paragraph num="(b)"> <text>In addition to payment for the legend drug ingredient cost, the Program shall establish and pay a dispensing fee for legend drugs;</text> </paragraph> <paragraph num="(c)"> <text>Duration of coverage for immunosuppressant drugs shall be consistent with Medicare policy;</text> </paragraph> <paragraph num="(d)"> <text>The Program shall only pay for a generic equivalent unless a brand is specified as medically necessary by the prescribing physician;</text> </paragraph> <paragraph num="(e)"> <text>The Program may not pay for more than a 34-day supply of an approved drug during a 26-day period;</text> </paragraph> <paragraph num="(f)"> <text>The Program may not pay for replacement of lost medications;</text> </paragraph> <paragraph num="(g)"> <text>The Program may pay for replacement of stolen medications when the claim is accompanied by a police report;</text> </paragraph> <paragraph num="(h)"> <text>A pharmacy provider shall maintain on file a hard copy of each prescription filled for a recipient; and</text> </paragraph> <paragraph num="(i)"> <text>The Program may not pay for legend drugs which are not FDA approved for the prescribed usage or which the FDA has declared to be “less-than-effective”.</text> </paragraph> </paragraph> </paragraph> <paragraph num="N."> <text>Reimbursement for Epogen (Epoetin alfa), dispensed as part of the dialysis procedure, shall be consistent with Medicare rates. Reimbursement shall be limited to dialysis facilities.</text> </paragraph> <paragraph num="O."> <text>Reimbursement for Procrit (Epoetin alfa) shall be consistent with Medicare rates. Coverage is limited to active renal transplant recipients.</text> </paragraph> <paragraph num="P."> <text>The Program shall provide reimbursement for access surgery required by a recipient for dialysis treatment even though the access surgery may predate the recipient's date of certification for Program benefits as established in accordance with Regulation .03 of this chapter.</text> </paragraph> <paragraph num="Q."> <text>To receive reimbursement from the Program a provider shall:</text> <paragraph num="(1)"> <text>Accept payment by the Program as payment in full and make no additional charge to any person for services covered by the Program;</text> </paragraph> <paragraph num="(2)"> <text>Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap;</text> </paragraph> <paragraph num="(3)"> <text>Verify the recipient's Program eligibility each time a service is provided by viewing the recipient's Kidney Disease Program identification card with a valid through date;</text> </paragraph> <paragraph num="(4)"> <text>Notify the Program immediately of any recipient or provider activity or circumstance that affects eligibility, benefits, or reimbursement;</text> </paragraph> <paragraph num="(5)"> <text>Maintain the confidentiality of all recipient information;</text> </paragraph> <paragraph num="(6)"> <text>Submit the request for payment for services rendered according to procedures established by the Program and in the form designated by the Program; and</text> </paragraph> <paragraph num="(7)"> <text>Maintain and make available administrative and medical records in accordance with the following requirements:</text> <paragraph num="(a)"> <text>Administrative and medical records shall contain documentation that is sufficient in quantity, scope, and detail to confirm that services are provided in accordance with this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Records shall be maintained for a minimum of 6 years; and</text> </paragraph> <paragraph num="(c)"> <text>Records shall be made available on request to the Department or the Department's designee.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Limitations."> <paragraph num="A."> <text>The Program does not cover a drug if:</text> <paragraph num="(1)"> <text>The manufacturer has not provided the same rebate to the Kidney Disease Program as that provided for State-Only Pharmacy Assistance recipients’ purchases of drugs as is required under §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c));</text> </paragraph> <paragraph num="(2)"> <text>The Program has provided notice to the manufacturer of the manufacturer’s failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>The manufacturer has failed to demonstrate to the Secretary that the drug's availability is essential to Kidney Disease Program recipients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Effective April 4, 2012, a manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation more than 1 year after the date the rebate was paid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment Procedures."> <paragraph num="A."> <text>A provider shall submit the request for Program payment for services rendered to a recipient according to procedures established by the Program and in the form designated by the Program.</text> </paragraph> <paragraph num="B."> <text>The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program.</text> </paragraph> <paragraph num="C."> <text>Billing Time Limits.</text> <paragraph num="(1)"> <text>The Program may not make payments for an invoice that the Program receives more than 6 months from the date of service, except for an invoice first submitted to Medicare, a health insurer, or other third party for reimbursement.</text> </paragraph> <paragraph num="(2)"> <text>For an invoice initially submitted to a third party for payment, the Program may not make payment unless the Program receives the invoice within 6 months of the date of service or 3 months of the third party's notification of payment action to the provider, whichever is later.</text> </paragraph> <paragraph num="(3)"> <text>The Program shall make payment on a claim which the Program returns to the provider due to improper completion or incomplete information only if the claim is properly completed, resubmitted, and received by the Program within the original 6 months, or within 3 months of being returned, whichever is later.</text> </paragraph> <paragraph num="(4)"> <text>If Medicare, or a third party rejects a provider’s claim because the claim was not received within the third party’s billing time limits, the Program may not make payment on that claim.</text> </paragraph> <paragraph num="(5)"> <text>If the Program denies payment due to late billing, a provider may not recover the amount later from either the recipient or the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Informal Reconsiderations and Hearings."> <paragraph num="A."> <text>Informal Reconsideration.</text> <paragraph num="(1)"> <text>An applicant, recipient, or provider dissatisfied with a decision, action, or inaction of the Department under this chapter shall be granted an opportunity for an informal reconsideration of the matter.</text> </paragraph> <paragraph num="(2)"> <text>The informal reconsideration shall include:</text> <paragraph num="(a)"> <text>Written notice to the applicant, recipient, or provider of the decision or action taken by the Department and the basis for the decision or action;</text> </paragraph> <paragraph num="(b)"> <text>If applicable, a written description of the basis for the Department's inaction;</text> </paragraph> <paragraph num="(c)"> <text>A reasonable opportunity for the applicant, recipient, or provider to refute the basis of the Department's decision, action, or inaction; and</text> </paragraph> <paragraph num="(d)"> <text>A written affirmation or reversal of the Department's decision, action, or inaction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The opportunity to refute the Department's decision, action, or inaction specified in §A(2)(c) of this regulation may be provided:</text> <paragraph num="(a)"> <text>In a meeting with a representative of the Program at the offices of the Program;</text> </paragraph> <paragraph num="(b)"> <text>By telephone conference; or</text> </paragraph> <paragraph num="(c)"> <text>In writing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings.</text> <paragraph num="(1)"> <text>The Department shall grant an opportunity for a hearing to an applicant or recipient who:</text> <paragraph num="(a)"> <text>Is determined to be ineligible for benefits under the Program;</text> </paragraph> <paragraph num="(b)"> <text>Is terminated from enrollment in the Program; or</text> </paragraph> <paragraph num="(c)"> <text>Is otherwise denied benefits under the Program due to a decision, action, or inaction of the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant or recipient requesting a hearing shall notify the Department of the request within 30 days of the date of receipt of the notice of final decision or intended action by the Department.</text> </paragraph> <paragraph num="(3)"> <text>Hearings shall be conducted in accordance with COMAR 10.01.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Program Recovery and Reimbursement."> <paragraph num="A."> <text>The Department shall seek recovery in all cases when Program benefits have been incorrectly paid.</text> </paragraph> <paragraph num="B."> <text>The Department shall accept reimbursement when voluntarily offered by a current or former recipient or someone acting on the recipient's behalf.</text> </paragraph> <paragraph num="C."> <text>The Department may institute any proceedings that the Department considers necessary to require collection of uncollected fees.</text> </paragraph> <paragraph num="D."> <text>The Program shall refer to the Central Collection Unit in the Department of Budget and Fiscal Planning for investigation and other appropriate action all cases in which a recipient has received coverage erroneously as a result of the action or inaction of the recipient.</text> </paragraph> <paragraph num="E."> <text>The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or person acting responsibly for the recipient.</text> </paragraph> <paragraph num="F."> <text>The Program shall require a recipient to authorize the release to the Department of all data, records, and information by insurance companies, nonprofit health service plans, providers of medical care, employers, unions, governmental agencies, and any other agencies, organizations, or individuals necessary for the Department's pursuit of third-party reimbursement. The authorization extends to all information relevant to third-party reimbursement or third-party health care coverage.</text> </paragraph> <paragraph num="G."> <text>The Department shall collect available benefits from third parties determined liable to pay for services received under the Program.</text> </paragraph> <paragraph num="H."> <text>A recipient who receives medical services that were or will be paid for by the Program is considered to have made assignment to the Department of the:</text> <paragraph num="(1)"> <text>Recipient's rights to any third-party payments for medical care; and</text> </paragraph> <paragraph num="(2)"> <text>Rights of any other individual eligible under the plan, for whom the recipient can legally make an assignment.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The assignment created under §H of this regulation shall be effective as long as the recipient is enrolled in the Program and remains effective for all services paid by the Program during this period of enrollment, and for those services which were erroneously provided to ineligible persons and paid for by the Program.</text> </paragraph> <paragraph num="J."> <text>If a recipient dies, the Department may make a claim against the estate of the recipient for any unpaid fee established for that recipient in accordance with the following:</text> <paragraph num="(1)"> <text>Except as provided in §J(4) of this regulation, a claim shall not be made for any fee for services provided more than 3 years before the recipient died;</text> </paragraph> <paragraph num="(2)"> <text>A claim under this section is a preferred claim against the estate of a deceased recipient;</text> </paragraph> <paragraph num="(3)"> <text>The claim may be waived by the Department if, in the Department's judgment, enforcement of the claim will cause substantial hardship to dependents of the deceased; and</text> </paragraph> <paragraph num="(4)"> <text>If a responsible relative who is liable for the cost of care of the recipient has misrepresented assets or submitted fraudulent information and, by doing so, has avoided any part of the claim for the cost of care, there is no limitation on the time in which the claim may be brought against the estate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Conflict with Regulations of the Kidney Disease Commission."> <text>Pursuant to Health-General Article, §13-308(e), Annotated Code of Maryland, the Department is authorized, after consulting with the Commission, to adopt these regulations. Accordingly, these regulations supersede any regulations issued by the Commission that concern nonmedical issues.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-315 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter, Control of Noise Pollution, transferred to Title 26 Department of the Environment, June, 1988</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10, General Regulations (Kidney Disease Program), adopted as an emergency provision effective November 1, 1991 (18:23 Md. R. 2481); emergency status expired March 30, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 adopted effective March 31, 1992 (19:3 Md. R. 304)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective November 29, 1999 (26:26 Md. R. 1958); revised permanently effective March 8, 2000 (27:4 Md. R. 454)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 21, 2004 (31:12 Md. R. 912); April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G, H amended effective June 21, 2004 (31:12 Md. R. 912)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective April 4, 2011 (38:7 Md. R. 431)</annotation> </annotations> </chapter> </subtitle> <subtitle num="21" heading="Behavioral Health Regulations"> <chapter num="01" heading="Involuntary Admission to Inpatient Mental Health Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the procedure for the involuntary admission of individuals to inpatient mental hygiene facilities, including State facilities, private psychiatric facilities, acute general hospitals with inpatient psychiatric units, and Veterans' Administration hospitals pursuant to Health-General Article, §§10-603, 10-613 — 10-617, 10-620, 10-631 — 10-633, and 10-803— 10-806, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>This chapter is not intended to impose any exhaustion requirement upon an individual as a prerequisite to the individual's pursuing concurrently or in any order any available legal remedy to obtain release from an inpatient facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Behavioral Health Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative law judge (ALJ)” means an individual in the Office of Administrative Hearings who is authorized under State Government Article, §9-1604, Annotated Code of Maryland, to conduct hearings under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Application for involuntary admission (Application for IVA)” means the application required under Health-General Article, §§10-614 and 10-615, Annotated Code of Maryland, to initiate the IVA of an individual to an inpatient facility.</text> </paragraph> <paragraph num="(4)"> <text>“Change of status hearing” means the IVA hearing that is convened when appropriate staff at an inpatient facility complete the application and certificates for IVA on behalf of an individual who is voluntarily admitted or court-ordered to the inpatient facility.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Discharge” means authorization by a physician for a voluntarily or involuntarily admitted individual to leave an inpatient facility.</text> </paragraph> <paragraph num="(7)"> <text>“Discharge summary” means a written evaluation by a physician that includes, at a minimum, the individual's diagnoses, summary of the treatment provided and progress during the current stay at the discharging inpatient facility, current mental status, prescribed medications, and treatment recommendations.</text> </paragraph> <paragraph num="(8)"> <text>“Geriatric Evaluation Services (GES)” means the staff of the county health departments that evaluate the appropriateness of admissions to State facilities or Veterans' Administration hospitals of individuals 65 years old or older.</text> </paragraph> <paragraph num="(9)"> <text>“Indigent” means that an individual has neither sufficient property to support the individual nor anyone able to support the individual to whom the individual is entitled to look for support.</text> </paragraph> <paragraph num="(10)"> <text>“Individual treatment plan (ITP)” means a treatment plan prepared for an individual in an inpatient facility according to the requirements outlined in Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03.</text> </paragraph> <paragraph num="(11)"> <text>Inpatient Facility.</text> <paragraph num="(a)"> <text>“Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders.</text> </paragraph> <paragraph num="(b)"> <text>“Inpatient facility” includes a Veterans' Administration (VA) hospital.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Involuntary admission (IVA)” means that an individual has been admitted to an inpatient facility by an ALJ following an IVA hearing pursuant to Health-General Article, §10-632, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Involuntary admission hearing (IVA hearing)” means an administrative proceeding at which an administrative law judge determines whether an individual who has been confined in an inpatient facility on the basis of application and certificates for IVA is retained as an inpatient or released from the inpatient facility without being admitted.</text> </paragraph> <paragraph num="(14)"> <text>“Medical clearance” means that an individual has been evaluated by a physician, a physician's assistant, or a nurse practitioner, and the evaluator has confirmed with the receiving inpatient facility that the receiving facility has the capacity to provide the necessary and appropriate medical management of the individual.</text> </paragraph> <paragraph num="(15)"> <text>“Medical record” means a record as defined in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>Mental Disorder.</text> <paragraph num="(a)"> <text>“Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder.</text> </paragraph> <paragraph num="(b)"> <text>“Mental disorder” includes a mental illness that substantially impairs the mental or emotional functioning of an individual so as to make care or treatment necessary or advisable for the welfare of the individual or for the safety of the person or property of another.</text> </paragraph> <paragraph num="(c)"> <text>“Mental disorder” does not include mental retardation or a primary diagnosis of alcohol or drug abuse.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Nolle pros” means “nolle prosequi” as set forth in Maryland Rule 4-247.</text> </paragraph> <paragraph num="(18)"> <text>“Observation status” means the status of an individual between the time the individual is initially confined in an inpatient facility on the basis of application and certificates for IVA and the time the individual is either admitted, voluntarily or involuntarily, to the inpatient facility or is released by a physician or by an ALJ from the inpatient facility without being admitted.</text> </paragraph> <paragraph num="(19)"> <text>“Office of Administrative Hearings (OAH)” means the office created under State Government Article, §9-1602, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Office of the Public Defender (OPD)” means the office created under Article 27A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Party” means the inpatient facility or the individual for whom an IVA hearing has been convened.</text> </paragraph> <paragraph num="(22)"> <text>“Petition for emergency evaluation” means a petition filed under the provisions of Health-General Article, §§10-620 — 10-629, Annotated Code of Maryland, to initiate the evaluation of an individual in an emergency facility that is designated by the Department, under the provisions of Health-General Article, §10-621, Annotated Code of Maryland, to perform emergency psychiatric evaluations.</text> </paragraph> <paragraph num="(23)"> <text>“Physician” means an individual who is licensed under Health Occupations Article, Title 14, Annotated Code of Maryland, to practice medicine in this State or, if the individual is working in a Veterans' Administration Hospital, authorized by the U.S. Department of Veterans' Affairs to practice medicine.</text> </paragraph> <paragraph num="(24)"> <text>“Physician’s, psychologist’s, or psychiatric nurse practitioner’s certificate” means the certificate completed according to the provisions of Health-General Article, §§10-616 — 10-617, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Presenter” means the individual, including an assistant attorney general, designated by the chief executive officer of an inpatient facility, who acts on behalf of the inpatient facility at an IVA hearing.</text> </paragraph> <paragraph num="(26)"> <text>“Psychiatric nurse practitioner” means an individual licensed under Health-Occupations Article, Title 8, Annotated Code of Maryland, to practice nursing in this State as a certified registered nurse practitioner-psychiatric mental health (CRNP-PMH).</text> </paragraph> <paragraph num="(27)"> <text>“Psychiatrist” means a physician who is identified as a specialist in psychiatry by the Board of Physician Quality Assurance or, if the physician is working in a Veterans' Administration Hospital, by the U.S. Department of Veterans' Affairs.</text> </paragraph> <paragraph num="(28)"> <text>“Psychologist” means an individual who is:</text> <paragraph num="(a)"> <text>Licensed under Health Occupations Article, Title 18, Annotated Code of Maryland, to practice psychology or, if the individual is working in a Veterans' Administration Hospital, authorized by the U.S. Department of Veterans' Affairs to practice psychology; and</text> </paragraph> <paragraph num="(b)"> <text>Listed in the National Register of Health Service Providers in Psychology.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Release” means the authorization for an individual who is confined in an inpatient facility on the basis of application and certificates for IVA to leave the inpatient facility:</text> <paragraph num="(a)"> <text>Given by a physician during the observation status period; or</text> </paragraph> <paragraph num="(b)"> <text>Ordered by an ALJ at an IVA hearing.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(31)"> <text>“Semiannual hearing” means the hearing that is held not sooner than 5 months or later than 6 months following an involuntarily admitted individual's last IVA hearing.</text> </paragraph> <paragraph num="(32)"> <text>“State inpatient facility” means an inpatient institution that is owned or operated by the State and that provides evaluation, care, or treatment for individuals who have mental disorders.</text> </paragraph> <paragraph num="(33)"> <text>“Stet” means the postponement of a trial pursuant to Maryland Rule 4-248.</text> </paragraph> <paragraph num="(34)"> <text>“Voluntary admission” means that an individual has been admitted to an inpatient facility on the basis of:</text> <paragraph num="(a)"> <text>A signed and endorsed formal application for voluntary admission pursuant to Health-General Article, §10-609 or 10-610, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>An informal request for admission pursuant to Health-General Article, §10-609, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>If the voluntary admission is to a VA hospital, the procedure established by the VA hospital.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Working day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Involuntary Admission (IVA)."> <paragraph num="A."> <text>An applicant for IVA shall:</text> <paragraph num="(1)"> <text>Have a legitimate interest in the welfare of the individual for whom IVA is sought;</text> </paragraph> <paragraph num="(2)"> <text>Submit an application on the form required by:</text> <paragraph num="(a)"> <text>The Veterans' Administration, if the application is submitted to a Veterans' Administration hospital; or</text> </paragraph> <paragraph num="(b)"> <text>The Administration, if the application is submitted to an inpatient facility other than a Veterans' Administration hospital;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Fill out the appropriate form completely; and</text> </paragraph> <paragraph num="(4)"> <text>Sign and date the application form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration shall provide an application form that includes the following:</text> <paragraph num="(1)"> <text>The statutory authority for the application;</text> </paragraph> <paragraph num="(2)"> <text>The form number (MDH34) and revision date;</text> </paragraph> <paragraph num="(3)"> <text>Spaces for the:</text> <paragraph num="(a)"> <text>Name of the inpatient facility to which the application for IVA is submitted;</text> </paragraph> <paragraph num="(b)"> <text>Name of the individual for whom IVA is sought;</text> </paragraph> <paragraph num="(c)"> <text>Name, home or agency address, telephone number, and relationship to the individual or official capacity of the applicant; and</text> </paragraph> <paragraph num="(d)"> <text>Signature of the applicant and the date that the application is made.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Physician’s, Psychologist’s or Psychiatric Nurse Practitioner’s Certificate for Involuntary Admission (IVA)."> <paragraph num="A."> <text>The following shall be submitted when initiating the IVA of an individual:</text> <paragraph num="(1)"> <text>An application for IVA completed under the provisions of Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>A certificate completed by:</text> <paragraph num="(a)"> <text>Two physicians;</text> </paragraph> <paragraph num="(b)"> <text>One physician and one psychologist; or</text> </paragraph> <paragraph num="(c)"> <text>One physician and one psychiatric nurse practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary shall provide the certificate that includes the following:</text> <paragraph num="(1)"> <text>The statutory authority for the certificate;</text> </paragraph> <paragraph num="(2)"> <text>The form number (MDH2) and revision date;</text> </paragraph> <paragraph num="(3)"> <text>A list of the appropriate documentation that shall be attached to one of the certificates;</text> </paragraph> <paragraph num="(4)"> <text>A statement that the certificate may not be used for the IVA of an individual if the examination on which the certificate is based was done:</text> <paragraph num="(a)"> <text>More than 1 week before the certificate is signed; or</text> </paragraph> <paragraph num="(b)"> <text>More than 30 days before the inpatient facility or the Veteran’s Administration hospital receives the application for admission;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A list of the State inpatient facilities and the catchment areas from which each facility accepts referrals;</text> </paragraph> <paragraph num="(6)"> <text>Spaces for the following information:</text> <paragraph num="(a)"> <text>The name, address, and telephone number of the certifying physician, psychologist, or psychiatric nurse practitioner;</text> </paragraph> <paragraph num="(b)"> <text>The name, address, identifying data, and the next of kin of the individual for whom the certificate is made;</text> </paragraph> <paragraph num="(c)"> <text>The date that the physician, psychologist, or psychiatric nurse practitioner examined the individual;</text> </paragraph> <paragraph num="(d)"> <text>A diagnosis of a mental disorder of the individual;</text> </paragraph> <paragraph num="(e)"> <text>An opinion that:</text> <paragraph num="(i)"> <text>The individual needs inpatient care or treatment; and</text> </paragraph> <paragraph num="(ii)"> <text>Admission to an inpatient facility is needed for the protection of the individual or another; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The individual's:</text> <paragraph num="(i)"> <text>Current medications; and</text> </paragraph> <paragraph num="(ii)"> <text>Emergency medications;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>A statement of whether the individual who completes the certificate is a physician, psychologist, or psychiatric nurse practitioner;</text> </paragraph> <paragraph num="(8)"> <text>The statement that the physician, psychologist, or psychiatric nurse practitioner:</text> <paragraph num="(a)"> <text>Has no financial interest, through ownership or compensation, in a proprietary inpatient facility, and admission to that proprietary inpatient facility is sought for the individual whose status is being certified; and</text> </paragraph> <paragraph num="(b)"> <text>Is not related, by blood or marriage, to the individual or to the applicant; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Space for the signature of the physician, psychologist, or psychiatric nurse practitioner and for the date and time the certificate is signed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To complete a certificate for IVA, a physician, psychologist, or psychiatric nurse practitioner shall:</text> <paragraph num="(1)"> <text>Personally examine an individual for whom an application for IVA has been completed under the provisions of Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Completely fill out the form described under §B of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Sign, date, and time the certificate not later than 1 week following the examination required under §C(1) of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Attach to one of the certificates for IVA copies of any available current medical reports or records that support the individual's need for involuntary care or treatment in an inpatient facility, with reports including at a minimum:</text> <paragraph num="(a)"> <text>The diagnosis of mental disorder, current symptoms, and psychiatric history;</text> </paragraph> <paragraph num="(b)"> <text>A summary of the medical history, including documentation of medical clearance;</text> </paragraph> <paragraph num="(c)"> <text>An explanation of why the individual meets the following requirements for IVA:</text> <paragraph num="(i)"> <text>The individual has a mental disorder;</text> </paragraph> <paragraph num="(ii)"> <text>The individual needs inpatient care or treatment;</text> </paragraph> <paragraph num="(iii)"> <text>The individual presents a danger to the life or safety of the individual or of others;</text> </paragraph> <paragraph num="(iv)"> <text>The individual is unable or unwilling to be admitted voluntarily;</text> </paragraph> <paragraph num="(v)"> <text>There is no available, less restrictive form of intervention that is consistent with the welfare and safety of the individual; and</text> </paragraph> <paragraph num="(vi)"> <text>Unless the individual is an emergency evaluee, if the individual is 65 years old or older and is being referred for admission to a State inpatient facility or a VA hospital, a GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the individual is an emergency evaluee, a copy of the petition for emergency evaluation; and</text> </paragraph> <paragraph num="(e)"> <text>If the individual is discharged from an inpatient facility after appropriate staff at the inpatient facility have completed application and certificates for IVA to initiate the direct confinement of the individual in another inpatient facility:</text> <paragraph num="(i)"> <text>The information outlined in §C(4)(a) — (d) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>The discharge summary;</text> </paragraph> <paragraph num="(iii)"> <text>A copy of the individual's most recent ITP completed in accordance with Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03; and</text> </paragraph> <paragraph num="(iv)"> <text>Copies of all voluntary and involuntary admissions documents relating to the current admission at the inpatient facility from which the individual is discharged.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An inpatient facility may not use for the admission of an individual a certificate that:</text> <paragraph num="(1)"> <text>Is based on an examination that was done:</text> <paragraph num="(a)"> <text>More than 1 week before the certificate is signed; or</text> </paragraph> <paragraph num="(b)"> <text>More than 30 days before the inpatient facility receives the application for admission; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Was previously used in connection with the taking into confinement on observation status an individual who subsequently was admitted to or released or discharged from an inpatient facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Notice of Status and Rights."> <paragraph num="A."> <text>If an individual is confined on observation status in an inpatient facility on the basis of an application and certificates for IVA, staff at the inpatient facility shall inform the individual of the individual's status and rights:</text> <paragraph num="(1)"> <text>By giving the individual the Notice of Status and Rights form described under §C of this regulation and provided by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>By explaining the information on the form to the individual in English or in the language and terms that are appropriate to the individual's condition and ability to understand; and</text> </paragraph> <paragraph num="(3)"> <text>At the following times:</text> <paragraph num="(a)"> <text>Within 12 hours of the individual's initial confinement in an inpatient facility on the basis of application and certificates for IVA under the provisions of Regulations .03 and .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>When certificates for IVA are executed for the purpose of changing the individual's status in accordance with Regulation .08B of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>When certificates are executed for the purpose of recertifying the individual for a semiannual hearing in accordance with Health-General Article, §10-806(d), Annotated Code of Maryland, and Regulation .08C of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Staff shall file a copy of the Notice of Status and Rights form in the individual's medical record and give copies to:</text> <paragraph num="(1)"> <text>When possible, the individual's parent, guardian, or next of kin; and</text> </paragraph> <paragraph num="(2)"> <text>If the individual does not understand the notice, the individual's:</text> <paragraph num="(a)"> <text>Parent, guardian, or next of kin;</text> </paragraph> <paragraph num="(b)"> <text>The applicant for IVA; and</text> </paragraph> <paragraph num="(c)"> <text>Any other person who has significant interest in the status of the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Administration shall provide a Notice of Status and Rights form that includes the following:</text> <paragraph num="(1)"> <text>The statutory authority for the notice;</text> </paragraph> <paragraph num="(2)"> <text>The form number (MDH33) and revision date;</text> </paragraph> <paragraph num="(3)"> <text>A statement of the rights provided under Health-General Article, §10-631, and Title 10, Subtitle 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>The right and access to legal counsel provided under Health-General Article, §10-631(a)(2) — (4), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>The hearing rights enumerated under Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09C of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>The right to request a judicial hearing on the cause and legality of the individual's admission and continued detention according to Health-General Article, §§10-804 and 10-805, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(7)"> <text>Spaces for:</text> <paragraph num="(a)"> <text>The name of the individual;</text> </paragraph> <paragraph num="(b)"> <text>The name of the inpatient facility;</text> </paragraph> <paragraph num="(c)"> <text>The basis for the individual's status and the provisions of law pertaining to the status;</text> </paragraph> <paragraph num="(d)"> <text>The signature of the individual and date that the individual received the notice;</text> </paragraph> <paragraph num="(e)"> <text>An explanation, if the individual does not sign the notice;</text> </paragraph> <paragraph num="(f)"> <text>An indication of whether the notice is given to a parent, guardian, or next of kin;</text> </paragraph> <paragraph num="(g)"> <text>An indication of whether the individual understands the notice; and</text> </paragraph> <paragraph num="(h)"> <text>Signature of inpatient facility staff who gives the notice to the individual and date that the notice is given.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Notice of Hearing."> <paragraph num="A."> <text>Staff at an inpatient facility shall inform an individual of the individual's right to an IVA hearing in accordance with the requirements for providing Notice of Status and Rights delineated in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Staff shall give the Notice of Hearing:</text> <paragraph num="(1)"> <text>Orally; and</text> </paragraph> <paragraph num="(2)"> <text>On the form provided by the OAH which shall include:</text> <paragraph num="(a)"> <text>The date, time, and place that the hearing will be held;</text> </paragraph> <paragraph num="(b)"> <text>The legal authority for and purpose of the hearing;</text> </paragraph> <paragraph num="(c)"> <text>A short statement explaining why the individual's involuntary admission is being sought;</text> </paragraph> <paragraph num="(d)"> <text>The standards delineated in Health-General Article, §10-632, Annotated Code of Maryland, that govern whether the individual shall be involuntarily admitted;</text> </paragraph> <paragraph num="(e)"> <text>Notice of the individual's right to consult with an attorney of the individual's choice and, if the individual is unable to afford an attorney, the availability of representation at the hearing through the Office of the Public Defender, Mental Health Division; and</text> </paragraph> <paragraph num="(f)"> <text>A list of the individual's rights at a hearing as set forth in Regulation .09C of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall file a copy of the Notice of Hearing form in the individual's medical record and give a copy to the individual's parent, guardian, or next of kin.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Observation Status."> <paragraph num="A."> <text>Upon a properly executed application executed in accordance with Regulation .03 of this chapter and certificates for IVA and all required attachments in accordance with Regulation .04 of this chapter, an inpatient facility that accepts individuals who are referred for IVA may take an individual into confinement on observation status.</text> </paragraph> <paragraph num="B."> <text>GES Evaluation. If an individual is an emergency evaluee, and the individual is 65 years old or older, on the first working day after the individual is taken into confinement on observation status, staff at a State inpatient facility or Veterans' Administration hospital shall:</text> <paragraph num="(1)"> <text>Notify the GES team in the county where the individual resides; and</text> </paragraph> <paragraph num="(2)"> <text>Document whether the GES grants clearance for the involuntary admission of the individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Examination.</text> <paragraph num="(1)"> <text>A psychiatrist shall examine an individual if the individual remains confined on observation status in an inpatient facility within 24 hours of the initial confinement.</text> </paragraph> <paragraph num="(2)"> <text>If a physician who examines an individual confined on observation status determines that the individual does not meet the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, the physician shall:</text> <paragraph num="(a)"> <text>If the individual meets the requirements for voluntary admission, offer the individual an application for voluntary admission; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately release the individual, following:</text> <paragraph num="(i)"> <text>Notification to the parent or guardian that the individual is being released, if the individual is a minor or is a disabled adult who is under guardianship of the parent or guardian under the provisions of Estates and Trusts Article, §13-708, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Preparation of a written aftercare plan in accordance with Health-General Article, §10-809, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Medical Records.</text> <paragraph num="(1)"> <text>An inpatient facility shall maintain the medical records for individuals who are confined on observation status separate from the inpatient medical records of the facility.</text> </paragraph> <paragraph num="(2)"> <text>The inpatient facility may not disclose an individual's observation status medical record in any way that would indicate that the individual had been present in the inpatient facility, except:</text> <paragraph num="(a)"> <text>For the sole purposes of:</text> <paragraph num="(i)"> <text>Providing notice of admission status and rights and notice of hearing to the individual's parent, guardian, or next of kin, in accordance with Regulations .05 and .06 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Calling witnesses to testify at the individual's IVA hearing; and</text> </paragraph> <paragraph num="(iii)"> <text>Fulfilling the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon the authorization of the individual.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staff at the inpatient facility where an individual is confined may use prior observation status medical records, as necessary, to provide for the proper care or treatment of the individual.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Rights. An individual who is confined on observation status in an inpatient facility shall be entitled to the rights granted in accordance with Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="F."> <text>An individual taken into an inpatient facility in accordance with §A of this regulation shall remain confined on observation status until the individual is:</text> <paragraph num="(1)"> <text>Voluntarily admitted to the inpatient facility in accordance with the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland, and if the individual is:</text> <paragraph num="(a)"> <text>A minor, a parent or guardian who is not a representative of a State agency signs an application for voluntary admission of a minor, in accordance with Health-General Article, §10-610, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A minor who is confined in a State inpatient facility, a parent or guardian has not previously executed an application for voluntary admission of a minor during the minor individual's current confinement in the State inpatient facility; and</text> </paragraph> <paragraph num="(c)"> <text>Not a disabled adult who is under guardianship of the person under the provisions of Estates and Trusts Article, §13-708, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Released by a physician of the inpatient facility before the scheduled IVA hearing pursuant to §C(2)(b) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Admitted to the inpatient facility by an ALJ following an IVA hearing in accordance with Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>Released from the inpatient facility by an ALJ following an IVA hearing in accordance with Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Discharge of an Individual on Observation Status and Referral for Direct IVA at Another Inpatient Facility. An inpatient facility may refer for IVA to another inpatient facility an individual who is confined on observation status only if the receiving inpatient facility agrees to have the hearing held within 10 days of the individual's initial confinement in the discharging inpatient facility on the basis of application and certificates for IVA.</text> </paragraph> <paragraph num="H."> <text>Payment or Reimbursement for Care or Treatment. Payment or reimbursement for care or treatment of an individual who is confined on observation status in, or who is involuntarily admitted to, an inpatient facility shall be in accordance with the provisions of Health-General Article, Title 16, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Schedule of IVA Hearings."> <paragraph num="A."> <text>Initial Hearing.</text> <paragraph num="(1)"> <text>When an individual is confined on observation status in an inpatient facility on the basis of application and certificates for IVA, inpatient facility staff shall:</text> <paragraph num="(a)"> <text>Schedule a hearing to take place within 10 days of the individual's initial confinement in the inpatient facility;</text> </paragraph> <paragraph num="(b)"> <text>Notify the OAH and the OPD that the hearing has been scheduled; and</text> </paragraph> <paragraph num="(c)"> <text>Give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing in accordance with Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The ALJ may postpone the hearing for good cause or by agreement of the parties, and the postponement shall be:</text> <paragraph num="(a)"> <text>For not more than 7 days;</text> </paragraph> <paragraph num="(b)"> <text>On the record; and</text> </paragraph> <paragraph num="(c)"> <text>One time only.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Change of Status Hearing.</text> <paragraph num="(1)"> <text>An inpatient facility that accepts individuals who are referred for IVA may initiate the procedure outlined in this section to change the admission status of an individual when, in the clinical judgment of the individual's treating physician, the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, and the individual is:</text> <paragraph num="(a)"> <text>Admitted voluntarily pursuant to Health-General Article, §10-609, Annotated Code of Maryland, and the individual requests discharge or otherwise demonstrates that the individual is unwilling or unable to continue to agree to voluntary treatment;</text> </paragraph> <paragraph num="(b)"> <text>A minor who is admitted on the basis of an application for voluntary admission of a minor signed by the parent or guardian, pursuant to Health-General Article, §10-610, Annotated Code of Maryland, and the:</text> <paragraph num="(i)"> <text>Parent or guardian requests release of the minor; or</text> </paragraph> <paragraph num="(ii)"> <text>Minor has been admitted to a State inpatient facility, and the minor is in need of care or treatment for longer than 20 days; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Admitted on the basis of a court order pursuant to Health-General Article, §12-104 or 12-110, Annotated Code of Maryland, and the Office of the State's Attorney or the court has agreed to dismiss, nolle prosequi, or stet the charges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Two physicians or one physician and one psychologist shall evaluate the individual and, if the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, shall submit an application for IVA of the individual in accordance with the provisions of Regulation .03 of this chapter and complete certificates for IVA in accordance with the provisions of Regulation .04 of this chapter:</text> <paragraph num="(a)"> <text>Within 3 days of the request for discharge, if the individual was admitted on the basis of a formal, written application for voluntary admission;</text> </paragraph> <paragraph num="(b)"> <text>Before 4 p.m. on the day of the request for discharge, if the individual was admitted voluntarily on the basis of an informal request;</text> </paragraph> <paragraph num="(c)"> <text>Before the expiration of the 20-day maximum stay, if the individual is a minor who was admitted to a State inpatient facility on the basis of an application for voluntary admission signed by the parent or guardian; and</text> </paragraph> <paragraph num="(d)"> <text>By the close of business of the next working day following official notification that the charges have been dismissed, nolle prossed, or stetted.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Following completion of the application and certificates for IVA under §B(2) of this regulation, staff at the inpatient facility shall:</text> <paragraph num="(a)"> <text>Schedule a hearing to take place within 10 days of the completion of application and certificates for IVA in accordance with §B(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Notify the OAH and the OPD that the hearing has been scheduled;</text> </paragraph> <paragraph num="(c)"> <text>Give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing pursuant to Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>If the individual is 65 years old or older and is in a State inpatient facility or Veterans' Administration hospital, and during the individual's current stay in the State facility or Veterans' Administration hospital the individual has not been approved for IVA by the GES:</text> <paragraph num="(i)"> <text>Notify the GES in the county of the individual's last residence that application and certificates for IVA have been completed; and</text> </paragraph> <paragraph num="(ii)"> <text>Document that the GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an inpatient facility does not accept individuals who are referred for IVA, and an individual is admitted voluntarily, pursuant to Health-General Article, §10-609, Annotated Code of Maryland, if the individual requests to be discharged from the inpatient facility or otherwise demonstrates that the individual is unwilling or unable to continue to agree to voluntary treatment, before discharging the individual, staff at the inpatient facility:</text> <paragraph num="(a)"> <text>May initiate the procedure outlined in §B(2) of this regulation and arrange to refer the individual to an inpatient facility that accepts individuals who are referred for IVA; and</text> </paragraph> <paragraph num="(b)"> <text>Shall assure that a hearing shall be held at the receiving inpatient facility within 10 days of completion of application and certificates for IVA in accordance with §B(2) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Semiannual Hearing.</text> <paragraph num="(1)"> <text>Facility staff shall schedule a hearing for the purpose of determining whether an individual continues to meet the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c)(i) — (v) of this chapter:</text> <paragraph num="(a)"> <text>Not sooner than 5 months or later than 6 months from the date that the individual is involuntarily admitted to an inpatient facility following an IVA hearing in accordance with §A or B of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Semiannually after that.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 7 days before the date a semiannual hearing is scheduled to take place:</text> <paragraph num="(a)"> <text>Two physicians or one physician and one psychologist or one physician and one psychiatric nurse practitioner shall complete certificates for IVA in accordance with the provisions of Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Staff at the inpatient facility shall give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing pursuant to Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Staff at the inpatient facility shall notify the OAH and the OPD that a hearing has been scheduled; and</text> </paragraph> <paragraph num="(d)"> <text>If the individual is 65 years old or older and is in a State inpatient facility or Veterans' Administration hospital, and during the individual's current stay in the State inpatient facility or Veterans' Administration hospital the individual has not been approved for IVA by the GES, State inpatient facility or Veterans' Administration hospital staff shall:</text> <paragraph num="(i)"> <text>Notify the GES in the county of the individual's last residence that certificates for IVA have been completed; and</text> </paragraph> <paragraph num="(ii)"> <text>Document that the GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A parent or guardian of a minor individual may not execute an application for voluntary admission of the minor at the time that a semiannual hearing is scheduled for the minor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Conduct of IVA Hearings."> <paragraph num="A."> <text>Powers and Duties of ALJ. An ALJ from the OAH shall conduct a hearing at the inpatient facility according to the rules of procedure outlined in COMAR 28.02.01.</text> </paragraph> <paragraph num="B."> <text>Location. Unless the ALJ, for good cause, relocates a hearing, the hearing shall take place in the inpatient facility where the individual is confined, and the inpatient facility shall provide a room that:</text> <paragraph num="(1)"> <text>During the hearing, is used for no other purpose;</text> </paragraph> <paragraph num="(2)"> <text>Has sufficient space and adequate and appropriate furnishings to accommodate the ALJ, the parties, and any others participating in the hearing; and</text> </paragraph> <paragraph num="(3)"> <text>Includes a speaker telephone that is adequate for the purpose of taking testimony by telephone.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Rights of Parties.</text> <paragraph num="(1)"> <text>At a hearing, the parties have the right to:</text> <paragraph num="(a)"> <text>Be represented by counsel;</text> </paragraph> <paragraph num="(b)"> <text>Present witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Cross-examine witnesses presented by the other party;</text> </paragraph> <paragraph num="(d)"> <text>Present documentary or other relevant evidence;</text> </paragraph> <paragraph num="(e)"> <text>Submit rebuttal evidence; and</text> </paragraph> <paragraph num="(f)"> <text>Present summation and argument.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition, an individual has the right to:</text> <paragraph num="(a)"> <text>Wear the individual's own clothes; and</text> </paragraph> <paragraph num="(b)"> <text>Be present or waive the right to be present, if the waiver is:</text> <paragraph num="(i)"> <text>Knowingly and intelligently made;</text> </paragraph> <paragraph num="(ii)"> <text>Witnessed by the individual's counsel; and</text> </paragraph> <paragraph num="(iii)"> <text>Witnessed by the ALJ.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Record of Hearing.</text> <paragraph num="(1)"> <text>The ALJ shall make and maintain a record of the hearing, and the record shall:</text> <paragraph num="(a)"> <text>Be an audio recording of the oral proceedings before the ALJ;</text> </paragraph> <paragraph num="(b)"> <text>Include a full description of the documentary evidence submitted at the hearing, but may not include the physical evidence itself;</text> </paragraph> <paragraph num="(c)"> <text>Be maintained for a period of 3 years following the hearing; and</text> </paragraph> <paragraph num="(d)"> <text>Upon request, be made available to a party to the hearing or to a party's counsel or authorized representative to listen to the record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon request by a party to the hearing, the OAH shall transcribe the record, and the record shall be:</text> <paragraph num="(a)"> <text>Paid for by the requesting party in accordance with the charges established in State Government Article, §10-621, Annotated Code of Maryland, and COMAR 10.01.08.14; or</text> </paragraph> <paragraph num="(b)"> <text>Provided without cost to an individual who:</text> <paragraph num="(i)"> <text>Has filed an appeal in proper person; and</text> </paragraph> <paragraph num="(ii)"> <text>Is indigent.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Testimony.</text> <paragraph num="(1)"> <text>The ALJ shall require the inpatient facility to provide for the testimony of one of the following, who has personally examined the individual within 48 hours before the hearing:</text> <paragraph num="(a)"> <text>A psychiatrist;</text> </paragraph> <paragraph num="(b)"> <text>A physician in an accredited residency program in psychiatry if the physician in the residency program in psychiatry is under the supervision of the psychiatrist who is responsible for the treatment of the individual who is the subject of the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>A psychologist.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the inpatient facility demonstrates exceptional and compelling circumstances, the ALJ shall require the examining psychiatrist, physician in the residency program in psychiatry identified under §E(1)(b) of this regulation, or psychologist, to testify in person at the hearing.</text> </paragraph> <paragraph num="(3)"> <text>If the ALJ determines that a certifying physician or, psychologist, has not submitted adequate information with the certificate and that additional testimony from the certifying physician or, psychologist, may materially assist the ALJ to make an informed decision, the ALJ may;</text> <paragraph num="(a)"> <text>Require the certifying physician or, psychologist, to attend and testify at the hearing; or</text> </paragraph> <paragraph num="(b)"> <text>Receive the testimony of the certifying physician or, psychologist, by telephone.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Burden of Proof. The burden of proof is on the inpatient facility to demonstrate by clear and convincing evidence that:</text> <paragraph num="(1)"> <text>The individual has a mental disorder;</text> </paragraph> <paragraph num="(2)"> <text>The individual needs inpatient care or treatment;</text> </paragraph> <paragraph num="(3)"> <text>The individual presents a danger to the life or safety of the individual or of others;</text> </paragraph> <paragraph num="(4)"> <text>The individual is unable or unwilling to be admitted voluntarily;</text> </paragraph> <paragraph num="(5)"> <text>There is no available, less restrictive form of intervention that is consistent with the welfare and safety of the individual; and</text> </paragraph> <paragraph num="(6)"> <text>If the individual is 65 years old or older and is being referred for admission to a State inpatient facility or VA hospital, a GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Findings and Conclusions. After the evidence and testimony are presented, and following summation and argument by the parties, the ALJ shall:</text> <paragraph num="(1)"> <text>Consider all evidence and testimony of record;</text> </paragraph> <paragraph num="(2)"> <text>Rule on issues raised by the individual that relate to the process by which the:</text> <paragraph num="(a)"> <text>Individual was taken into and confined during observation status;</text> </paragraph> <paragraph num="(b)"> <text>Individual's admission status was changed according to the provisions of Regulation .08B of this chapter; or</text> </paragraph> <paragraph num="(c)"> <text>Individual is presented for a semiannual hearing under the provisions of Regulation .08C of this chapter;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Order the release of the individual from the inpatient facility if:</text> <paragraph num="(a)"> <text>An error in the process occurred;</text> </paragraph> <paragraph num="(b)"> <text>The error in the process is substantial; and</text> </paragraph> <paragraph num="(c)"> <text>No other available remedy is consistent with due process and the protection of the individual's rights;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Order the release of the individual from the inpatient facility unless the inpatient facility meets the burden of proof outlined in §F of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>State on the record the:</text> <paragraph num="(a)"> <text>Findings, including whether the individual waived the right to attend the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Conclusions of law on any relevant issue presented;</text> </paragraph> <paragraph num="(c)"> <text>Right of the individual to appeal the decision of the ALJ pursuant to State Government Article, §§10-215 and 10-216, Annotated Code of Maryland, and the procedure for requesting an appeal; and</text> </paragraph> <paragraph num="(d)"> <text>Right of the individual to seek judicial release from the inpatient facility pursuant to the provisions of Health-General Article, §§10-804 and 10-805, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Give to the individual a written decision which shall:</text> <paragraph num="(a)"> <text>Be on the form provided by the OAH;</text> </paragraph> <paragraph num="(b)"> <text>Include the conclusions and the rights enumerated under §G(5) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>State whether the inpatient facility has proven that the individual meets each of the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and §F of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>By copy, be:</text> <paragraph num="(i)"> <text>Given to the presenter;</text> </paragraph> <paragraph num="(ii)"> <text>Filed in the individual's medical record; and</text> </paragraph> <paragraph num="(iii)"> <text>If the individual is a minor, given to the individual's parent or guardian if the parent or guardian is present at the hearing.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Evaluation Following ALJ Release."> <text>If an individual is released from an inpatient facility by an ALJ under the provisions of Regulation .09G(3) of this chapter, and the individual’s treating physician, psychologist, or psychiatric nurse practitioner determines, based on the individual’s behavior and clinical condition after the hearing, that the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c)(i) — (v) of this chapter:</text> <paragraph num="A."> <text>After the individual has been given the opportunity to leave the inpatient facility, the treating physician, psychologist, or psychiatric nurse practitioner may file a petition for emergency evaluation as the means of initiating an emergency psychiatric evaluation; and</text> </paragraph> <paragraph num="B."> <text>The inpatient facility may not accept the application and certificates for IVA that initiated the individual's initial confinement under Regulation .07A of this chapter for the purpose of taking the individual into confinement on observation status following the release.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Discharge of an Involuntarily Admitted Individual and Referral for IVA in Another Inpatient Facility."> <text>Unless an individual is discharged from one State inpatient facility and referred for IVA in another State inpatient facility:</text> <paragraph num="A."> <text>When an inpatient facility discharges an individual who has been involuntarily admitted pursuant to Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter, and refers the individual for IVA in another inpatient facility, appropriate staff at the discharging inpatient facility shall:</text> <paragraph num="(1)"> <text>Complete an application and certificates for IVA, including the required documentation outlined in Regulation .04C(4) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>On or before the date of the referral for IVA, provide all the records necessary for the continuing care or treatment of the individual pursuant to Health-General Article, §§4-306(a)(5), 4-307(h)(1)(i), 10-807(d), and 19-308.2, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon arrival of an individual who is referred for IVA and receipt of the documentation listed in §A of this regulation, the receiving inpatient facility shall:</text> <paragraph num="(1)"> <text>Take the individual into observation status in accordance with Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Schedule an IVA hearing in accordance with the provisions of Regulation .08A of this chapter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204 — 7.5-205, 10-603, 10-615 — 10-616, 10-619 and 10-806(d)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 5, 1970</annotation> <annotation type="History" subtype="Administrative History">Amended effective October 1, 1973</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 12, 1981 (8:20 Md. R. 1635)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.21.01.04B and .07E cited in Attorney General Opinion No. 86-031 (May 12, 1986)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 repealed and new Regulations .01 — .11 adopted effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective September 13, 1993 (20:18 Md. R. 1430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 409); January 2, 2017 (43:26 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective January 2, 2017 (43:26 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective September 13, 1993 (20:18 Md. R. 1430)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> </annotations> </chapter> <chapter num="02" heading="Psychiatric Day Treatment Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>“Adolescents” means persons 13 to 18 years old.</text> </paragraph> <paragraph num="B."> <text>“Board” means the executive authority and policy-making group which operates a psychiatric day treatment center for mentally ill persons.</text> </paragraph> <paragraph num="C."> <text>“Children” means persons younger than 13 years old.</text> </paragraph> <paragraph num="D."> <text>“Consumer” means a person who has received or is receiving services in any program, public or private, providing mental health services or is the relative of a person receiving or having received these services.</text> </paragraph> <paragraph num="E."> <text>“Full treatment day” for the purposes of these regulations means 6-1/2 hours. The minimum unit of service or half treatment day is 4 consecutive hours.</text> </paragraph> <paragraph num="F."> <text>“Health authority” means the Maryland Department of Health or a designated local health officer.</text> </paragraph> <paragraph num="G."> <text>“Psychiatric day treatment center” means the premises on which psychiatric day treatment is provided.</text> </paragraph> <paragraph num="H."> <text>“Psychiatric day treatment services” means intensive, nonresidential psychiatric treatment for any part of a 24-hour day for a minimum of 4 consecutive hours per day. Patients admitted to these services are those for whom at the time of admission, it is reasonable to anticipate that maximum day treatment benefits would be achieved within 30 full treatment days. If at any point in the course of treatment it is believed that patients would benefit from additional intensive treatment, beyond the 30-day period, continued day treatment may be provided, but the record shall document justification for the continued intensive treatment. Day treatment services provide flexible scheduling to meet the needs of the individual patient so that the 30 treatment days may nor may not be consecutive. The services given may be part of a psychiatric hospital program, or a psychiatric unit of a general hospital, or a free-standing community-based mental health program which has an arrangement for appropriate support services with a licensed general hospital or a licensed psychiatric hospital. Psychiatric day treatment services provide active psychiatric treatment. Psychiatric day treatment services do not provide residential care, nor are they identical with socializing and activity programs, recreational community programs, or day care facilities which do not provide active psychiatric treatment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="General Provisions."> <paragraph num="A."> <text>Program Approval. Psychiatric day treatment services which are under the auspices of a psychiatric unit located in a licensed psychiatric hospital or under the auspices of a psychiatric unit of a licensed acute general hospital shall be reviewed and approved by the Mental Hygiene Administration on the basis of these regulations. Free-standing psychiatric day treatment services and those under the auspices of a community mental health program shall also be reviewed and approved by the Mental Hygiene Administration on the basis of these regulations.</text> </paragraph> <paragraph num="B."> <text>Standards for Psychiatric Day Treatment Services.</text> <paragraph num="(1)"> <text>The daily treatment program shall provide intensive treatment following a treatment plan developed by a multi-disciplinary staff team on the basis of an evaluation of the patient's needs. A variety of psychiatric modes shall be available, including psychopharmacological treatment, occupational therapy, activity therapy, and other necessary medical, psychological, and social services.</text> </paragraph> <paragraph num="(2)"> <text>There shall be an acceptable plan and procedure which fix responsibility for the care and treatment of the patient if an emergency occurs during the patient's stay within the day treatment service.</text> </paragraph> <paragraph num="(3)"> <text>The treatment center shall have an agreement with at least one licensed general or psychiatric hospital to provide inpatient services as needed.</text> </paragraph> <paragraph num="(4)"> <text>The day treatment program shall assure continuity of care by developing appropriate mechanisms for referral to outpatient services if the patient does not have a private therapist and to necessary support and residential services, developing written agreements whenever feasible. When patients continue in treatment with a therapist who is not a member of the day treatment program team, the program shall have an agreement with the therapist which clearly delineates relative treatment responsibilities of the day treatment team and the other therapist.</text> </paragraph> <paragraph num="(5)"> <text>A registered nurse shall be on the premises throughout the treatment day.</text> </paragraph> <paragraph num="(6)"> <text>Within 4 working days of admission, every patient shall have an individual treatment plan, developed collaboratively by a multi-disciplinary team, which clearly defines expectations and means of accomplishing the goals of the plan. The treatment plan shall be signed by the psychiatrist responsible for its development. The names of the other members of the mental health treatment team involved in the development of the plan shall be listed adjacent to the signature of the psychiatrist. The treatment plan shall describe the patient's problems and probable diagnosis, state the short- and long-term goals of treatment, and delineate the modalities, including medications, to be used to accomplish these goals. The treatment plan shall record any physical condition which can affect the treatment plan.</text> </paragraph> <paragraph num="(7)"> <text>There shall be a utilization review committee which shall include at least one qualified person who has no financial or other direct interest, past or present, in the treatment of the patient or the operation of the program. In addition to its other duties, the committee shall review the treatment plans for patients whose expected length of stay exceeds 30 full treatment days.</text> </paragraph> <paragraph num="(8)"> <text>Programs for children, adolescents, and adults shall be separate, although some activities may be shared with mutual benefit.</text> </paragraph> <paragraph num="(9)"> <text>Each day treatment program shall describe in writing its mechanisms for quality assurance, including systematic case review and program evaluation, and shall define the composition and responsibilities of the utilization review committee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Capacity of Psychiatric Day Treatment Center. The number of persons treated at any one time in each psychiatric day treatment center shall be limited according to the premises, staff, and equipment as set forth in Regulation .10 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Admission Policies."> <paragraph num="A."> <text>Criteria for admission shall be established for types of patients the program is designed to benefit, the goals and objectives of treatment, and the means by which these goals and objectives will be accomplished.</text> </paragraph> <paragraph num="B."> <text>Admission criteria may not discriminate against anyone on the basis of age, sex, race, creed, color, national origin, or handicapping conditions. For clinical purposes, program services may be offered for defined target groups.</text> </paragraph> <paragraph num="C."> <text>Admission criteria shall take into account the physical and medical status of the patient. Measures shall be taken to assure that patients are free from communicable diseases, such as tuberculosis.</text> </paragraph> <paragraph num="D."> <text>Programs shall require that the referring source submit written records whenever possible.</text> </paragraph> <paragraph num="E."> <text>Criteria for admission shall be available to the utilization review committee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Discharge Policies."> <text>Criteria for discharge shall be established and shall be available for use by the utilization review committee. Discharge criteria may include, but not be limited to, symptomatic improvement; readiness for participation in voluntary, educational, or vocational programs; achievement of treatment goals; inability to comply with program requirements; or the need for 24-hour hospitalization.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Records."> <paragraph num="A."> <text>Clinical records shall contain sufficient information to identify the patient clearly, to support the diagnosis, to justify the treatment plan, and to document the results accurately.</text> </paragraph> <paragraph num="B."> <text>A clinical record shall be established for every person admitted to a day treatment program and shall include:</text> <paragraph num="(1)"> <text>Identifying information, including names, current addresses, and telephone numbers of the patients, relatives, or guardians;</text> </paragraph> <paragraph num="(2)"> <text>Presenting problem, the results of mental and physical examinations, diagnosis, treatment plan, a record of the implementation of the treatment plan, and the discharge disposition and referrals;</text> </paragraph> <paragraph num="(3)"> <text>Evidence of appropriate release-of-information procedures and informed consent, if applicable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A system of identification and filing of clinical records shall be maintained to facilitate the prompt location of the patient's clinical record.</text> </paragraph> <paragraph num="D."> <text>Provision shall be made for storing records to assure their security and to maintain their confidentiality.</text> </paragraph> <paragraph num="E."> <text>The record shall be retained for at least 3 years after the discharge of a patient unless the patient is a minor. In that case, it shall be retained for at least 3 years past the date on which the minor would reach the age of majority. Record retention by State or State-funded programs shall conform to the requirements of the records management division.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Staff."> <paragraph num="A."> <text>Professional and paraprofessional staff shall be adequate to carry out the treatment program.</text> </paragraph> <paragraph num="B."> <text>Minimum requirements for the staff are as follows:</text> <paragraph num="(1)"> <text>The staff of a psychiatric day treatment program shall be a multi-disciplinary team, including a psychiatrist, a registered nurse, and representatives of other appropriate disciplines, at least on a part-time basis.</text> </paragraph> <paragraph num="(2)"> <text>The psychiatrist on the team shall be responsible for overall patient care. The mental health team, including a psychiatrist, shall evaluate and make a diagnosis for each patient and shall develop a treatment plan. After the treatment plan is made, a psychiatrist shall be involved in the treatment plan as needed and shall be available on call. He shall meet with the staff at least weekly to review treatment plans for each individual patient.</text> </paragraph> <paragraph num="(3)"> <text>Each day treatment program shall have a director with clearly defined authority and responsibility for administration and service.</text> </paragraph> <paragraph num="(4)"> <text>Each program shall establish a system of supervision and of continuing education and training for all staff, including any students.</text> </paragraph> <paragraph num="(5)"> <text>If volunteers are employed in patient care, programs shall provide a system of screening and training volunteers. Volunteers shall receive continuing supervision in their activities. The supervisor shall assure that volunteers are not asked to perform duties beyond their skill and understanding.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Medications."> <text>Medications shall be stored separately in locked facilities and dispensed by qualified staff, in conformity with Health Occupations Article, §12-301, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Organizational and Administrative Structure."> <paragraph num="A."> <text>Any corporation delivering day treatment services shall have a valid charter of incorporation.</text> </paragraph> <paragraph num="B."> <text>Every day treatment program shall have a mechanism to assure community and consumer participation in the establishment of policies and procedures related to the operation of the program and for continuing review and evaluation of the implementation of these policies. Participation may be provided by inclusion of consumer and community representatives in the membership of the board of directors, if one exists, or by an advisory board whose members include consumer and community representatives. Existing boards of directors or advisory boards of sponsoring agencies may perform this function if consumer and community interests are appropriately represented.</text> </paragraph> <paragraph num="C."> <text>Standards for Administration of Day Treatment Programs.</text> <paragraph num="(1)"> <text>There shall be an organizational chart clearly showing intra-organizational relationships and lines of authority.</text> </paragraph> <paragraph num="(2)"> <text>Every program shall have a policies-and-procedures manual which, among other elements, describes its mission, its geographic service area, its target population, its organizational structure, its clinical policies, its operating procedures, types of services provided, with responsibility for supervision clearly defined.</text> </paragraph> <paragraph num="(3)"> <text>There shall be a personnel policy manual which shall include written job descriptions for all staff positions, policies and procedures for personnel evaluation, and grievance procedures.</text> </paragraph> <paragraph num="(4)"> <text>Every program shall have an itemized budget showing all sources of income and the services being funded.</text> </paragraph> <paragraph num="(5)"> <text>All programs shall maintain a generally accepted accounting system.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Patient Rights.</text> <paragraph num="(1)"> <text>Written policies describing patient rights shall be made available to persons admitted to the service.</text> </paragraph> <paragraph num="(2)"> <text>All patient information, verbal and written, shall be held confidential and restricted to staff members engaged in the treatment of the patient, to individuals authorized to participate in quality assurance and utilization review of records, and to designated representatives of authorized funding, licensing, and certifying agencies which must evaluate programs in order to carry out their responsibilities. With proper authorization from the patient, relevant information may be disclosed to staff members of agencies providing necessary social and other support services to the patient.</text> </paragraph> <paragraph num="(3)"> <text>Program staff shall provide the patient in writing with a description of the program, including admissions and discharge policies, and an explanation of charges and methods of determining fees.</text> </paragraph> <paragraph num="(4)"> <text>Program staff shall establish mechanisms to assure the patient of the opportunity to be consulted and informed on procedures related to his care. The leader of the patient's treatment team shall give him, on request, current information in regard to his treatment and condition.</text> </paragraph> <paragraph num="(5)"> <text>Program staff shall inform patients receiving chemotherapy of the effects of the medication, including benefits and possible side effects.</text> </paragraph> <paragraph num="(6)"> <text>Program staff shall establish mechanisms for patients to register grievances and for appeal and review.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Process of Approval and Appeal."> <paragraph num="A."> <text>The Mental Hygiene Administration shall be responsible for approving the programmatic aspects of the day treatment services. Approval shall be issued on the basis of a formal scheduled site visit by a designated evaluation team of the Administration on the basis of these regulations.</text> </paragraph> <paragraph num="B."> <text>Initial Approval.</text> <paragraph num="(1)"> <text>The site-visit team shall make a recommendation for approval or disapproval in writing to the Director of the Mental Hygiene Administration. A copy of the recommendation shall be sent simultaneously to the program.</text> </paragraph> <paragraph num="(2)"> <text>The program shall have the right to question the recommendation of the evaluation team by sending a reply in writing to the Director of the Mental Hygiene Administration within 20 days of the receipt of the recommendation. This reply shall give reasons why the recommendation is not justified.</text> </paragraph> <paragraph num="(3)"> <text>Upon request, a conference shall be held with all parties present before the final determination.</text> </paragraph> <paragraph num="(4)"> <text>The Director of the Mental Hygiene Administration shall have the final decision for granting or withholding approval to programs after consideration of the position presented by the evaluated program and after consultation with members of the site-visit team.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provisional Approval. Provisional approval may be granted to programs in which the deficiencies cited have no adverse effect on the life-safety or health status of patients and the facility has concrete plans to correct these deficiencies by a prescribed date. The Mental Hygiene Administration may establish conditions in giving provisional approval and set a date by which those conditions shall have been met.</text> </paragraph> <paragraph num="D."> <text>Revocation of Approval.</text> <paragraph num="(1)"> <text>Approval may be revoked after notice and hearing before the Director of the Mental Hygiene Administration or his designee upon finding of failure to comply with standards or to comply with conditions of approval when a provisional approval has been given.</text> </paragraph> <paragraph num="(2)"> <text>Notice of an intent to revoke approval and the grounds for the revocation shall be given in writing to the Director of the program.</text> </paragraph> <paragraph num="(3)"> <text>The program shall have the right to file a reply in writing to the notice of intent to revoke within 20 days of the receipt of the notice. The reply shall set forth why the revocation is not justified.</text> </paragraph> <paragraph num="(4)"> <text>The program shall have the right to representation by counsel, and the hearing shall follow procedures set forth in COMAR 10.01.03 Procedures for Hearings Before the Secretary of Health.</text> </paragraph> <paragraph num="(5)"> <text>A program whose approval has been revoked may appeal the decision to the Secretary of Health under Article 41, §251, according to the procedures set forth in COMAR 10.01.03 Procedures for Hearings Before the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Physical Plant."> <paragraph num="A."> <text>Location. The premises on which a psychiatric day treatment center is to be located shall be served by a good road. Accessible public transportation is desirable.</text> </paragraph> <paragraph num="B."> <text>Communication. There shall be at least one telephone readily available — not a pay station or locked telephone — in the building and additional telephones or extensions as may be required to summon help promptly in case of fire or other emergencies.</text> </paragraph> <paragraph num="C."> <text>Buildings.</text> <paragraph num="(1)"> <text>Any building used for a psychiatric day treatment center shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness. All floors, walls, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning. The building shall be accessible to the handicapped. The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items. All paint shall be free from lead.</text> </paragraph> <paragraph num="(2)"> <text>The director shall provide for the safety and protection of all occupants and assure the elimination of all hazards. Adequate provision and training shall be made for fire-control equipment, fire escapes, and evacuation of persons in case of fire or other emergency. Fire drills shall be held on a regular basis.</text> </paragraph> <paragraph num="(3)"> <text>Any proposed alterations, additions, or changes shall be submitted to the health authority so that they may be approved or disapproved with such recommendations as deemed necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Sanitation.</text> <paragraph num="(1)"> <text>Sewage Disposal. The method of sewage disposal shall conform to COMAR 10.17.03 and be approved by the health authority.</text> </paragraph> <paragraph num="(2)"> <text>Water Supply. A safe drinking-water supply, as determined by COMAR 10.17.02 and approved by the health authority, shall be provided.</text> </paragraph> <paragraph num="(3)"> <text>Plumbing. All plumbing and plumbing fixtures shall be so constructed, installed, and maintained as to prevent cross-connections or other sanitation hazards, as required by the applicable State and local plumbing codes.</text> </paragraph> <paragraph num="(4)"> <text>Garbage and Refuse Disposal. Garbage and refuse shall be kept in watertight metal containers with tight-fitting covers and shall be removed from the premises at frequent intervals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Heating.</text> <paragraph num="(1)"> <text>The building, whenever possible, shall be equipped with a heating plant with design capability of maintaining a temperature of 75°F in mean winter temperatures in patient areas.</text> </paragraph> <paragraph num="(2)"> <text>Space heaters and portable heaters are prohibited.</text> </paragraph> <paragraph num="(3)"> <text>Chimney, flues, and pipes connected with the heating facility shall be checked and cleaned annually.</text> </paragraph> <paragraph num="(4)"> <text>The fuel supply shall be handled according to the regulations of the State Fire Prevention Commission. If coal is used, ashes may not be stored in flammable containers pending disposal.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Insects and Rodents. The premises shall be maintained free of insects and rodents through an active pest-control program and elimination of garbage.</text> </paragraph> <paragraph num="G."> <text>Gas and Electric Appliances. All gas appliances shall be installed and used in accordance with the applicable codes.</text> </paragraph> <paragraph num="H."> <text>Screens.</text> <paragraph num="(1)"> <text>All outside doors, windows, and other outside openings shall be screened with wire screen or its equal with not less than 16 meshes per linear inch.</text> </paragraph> <paragraph num="(2)"> <text>All screen doors shall be equipped with self-closing devices and, when closed, fit tightly enough to prevent entrance of flies, mosquitoes, other insects, and rodents.</text> </paragraph> <paragraph num="(3)"> <text>Window screens shall fit closely enough to keep out insects and be easily removed.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Lighting. Each area used for therapy purposes shall be provided with sufficient artificial lighting so that the combined natural and artificial lighting shall be capable of providing a minimum illumination of 100-foot candles at work surfaces at all times when the psychiatric day treatment center. is in operation and at least 20-foot candles on all stairways and corridors. Glare shall be kept at a minimum by:</text> <paragraph num="(1)"> <text>Providing shades or curtains at all windows exposed to direct sunlight unless seating is arranged so that no person while at work will be required to face a glaring surface;</text> </paragraph> <paragraph num="(2)"> <text>Using lighting fixtures designed so that bare lamps or tubes are shielded at normal viewing angles;</text> </paragraph> <paragraph num="(3)"> <text>Using light-colored flat paint or other light finishes on ceilings and upper side walls (semi-gloss finishes may be used on lower side walls and other wood trim where frequent cleaning is necessary);</text> </paragraph> <paragraph num="(4)"> <text>Employing non-glossy, light-colored finishes on work tables to minimize glare by reflection.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Space and Ventilation Requirements.</text> <paragraph num="(1)"> <text>Adequate space to meet the requirements of program activities shall be available. Space for individual and group therapy, for occupational and activities therapy, and a kitchen area for patient use in acquiring and practicing activities of daily living shall be available.</text> </paragraph> <paragraph num="(2)"> <text>Rooms with a total window area of less than 10 percent and an openable window area of less than 5 percent of the floor area may be used only if there is provision for air exchange and ventilation according to the standards of the ASHRAE Code.</text> </paragraph> <paragraph num="(3)"> <text>Healthful humidity and comfortable temperatures shall be maintained in patient areas during the summer months.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Sanitary Facilities.</text> <paragraph num="(1)"> <text>The drinking-water supply may not be located in the bathroom. One drinking-water facility shall be available for every 4o persons or fewer on each floor.</text> </paragraph> <paragraph num="(2)"> <text>There shall be one toilet and one lavatory provided for every 10 persons of the same sex or fewer. The lavatory shall be in close proximity to each toilet. The floor in each toilet room shall have a waterproof, non-absorbent finish, and the walls shall be smoothly finished with a hard surface. Grab bars shall be provided in toilets and bathing areas.</text> </paragraph> <paragraph num="(3)"> <text>Towels shall be of the single-service type and shall be provided on single-service towel dispensers in all toilet rooms. Mechanical hand-drying devices may be used instead of towel dispensers.</text> </paragraph> <paragraph num="(4)"> <text>There shall be hot and cold running water, soap, and toilet paper provided in the toilet rooms at all times. The temperatures of the hot water may not exceed 125°F in patient areas.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Food Facilities. If food is prepared on the premises, the applicable sections of COMAR 10.15.03 relating to approved source of food, food temperatures and storage, storage of dangerous chemicals, handwashing, and dishwashing (sanitizing) shall serve as the standards.</text> </paragraph> <paragraph num="M."> <text>Safety.</text> <paragraph num="(1)"> <text>Stairways shall be kept free of obstructions. Fire-exit doors shall be maintained in working order. The facility shall be free of mechanical and electrical hazards. Non-slip surfaces and coverings shall be provided in risk areas, such as tubs, showers, and stairways.</text> </paragraph> <paragraph num="(2)"> <text>Poisonous and flammable products are prohibited unless stored in accordance with State Fire Prevention code requirements.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Provisions for Handicapped. Provisions for the handicapped shall be made according to the American National Standards Institute (ANSI) A 117.1 to meet the anticipated needs of the population served.</text> </paragraph> <paragraph num="O."> <text>Janitors' Closets and Slop Sinks.</text> <paragraph num="(1)"> <text>The facility shall provide janitors' closets with slop sinks as follows:</text> <paragraph num="(a)"> <text>At least one per building shall be provided in non-hospital-based programs;</text> </paragraph> <paragraph num="(b)"> <text>At least one for every 100 persons, one per resident building, or one per resident floor, whichever is most stringent, shall be provided in hospital-based programs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mops and supplies may not be stored on the floor in the closet.</text> </paragraph> <paragraph num="(3)"> <text>The closet shall be vented to the outside.</text> </paragraph> </paragraph> <paragraph num="P."> <text>Storage. Storage areas shall be provided and located according to efficiency of scheduling, operation, and patient needs.</text> </paragraph> <paragraph num="Q."> <text>Minimal Equipment. Minimal equipment for a psychiatric day treatment center shall be adequate to meet the demands of the program according to the number of clients in attendance.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 25, 1961</annotation> <annotation type="History" subtype="Administrative History">Amended effective August 4, 1965 and April 15, 1974</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 29, 1981 (8:11 Md. R. 974)</annotation> </annotations> </chapter> <chapter num="03" heading="Requirements for Individual Treatment Plans"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations shall apply to every individual admitted either voluntarily or involuntarily to any inpatient mental health facility licensed by, or under the jurisdiction of, the Maryland Department of Health. These regulations may not apply to institutions for the care of developmentally disabled patients, or to those patients committed by the courts for evaluation only.</text> </paragraph> <paragraph num="B."> <text>These regulations are supplemental to any other laws and regulations that may be applicable. In the event of conflict between these regulations or laws and any other regulations or laws, the more stringent shall apply.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>“Active treatment” means the regular participation by a patient in professionally developed and supervised activities, experiences, or therapies based on an individual treatment plan.</text> </paragraph> <paragraph num="B."> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="C."> <text>“Mental health professional treatment team” means:</text> <paragraph num="(1)"> <text>One or more duly licensed physicians or psychiatrists, one of whom shall assume responsibility for the development and implementation of an individual treatment plan. If the physician member of the mental health professional treatment team has less than 2 years of post-degree experience in a mental health setting, at least one other member of the team shall have attained the master's degree and have 2 years of post-degree experience in a mental health setting.</text> </paragraph> <paragraph num="(2)"> <text>One or more of the following mental health professionals:</text> <paragraph num="(a)"> <text>A psychologist, licensed in the State, or an individual with a master's degree in psychology or a related field from an accredited college or university in a program acceptable to the Board of Examiners of Psychologists, under the supervision of a licensed psychologist, and with at least 2 years of postdegree experience in a mental health setting;</text> </paragraph> <paragraph num="(b)"> <text>A professional registered nurse licensed in the State with at least one of the following credentials:</text> <paragraph num="(i)"> <text>Two years of psychiatric nursing experience;</text> </paragraph> <paragraph num="(ii)"> <text>A bachelor of science degree and 1 year of psychiatric experience; or</text> </paragraph> <paragraph num="(iii)"> <text>A master's degree and 1 year of psychiatric nursing experience;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A social worker, licensed in the State, with a master's degree in social work from an accredited school of social work and 2 years experience, 1 of which shall have been in a mental health setting; or</text> </paragraph> <paragraph num="(d)"> <text>An occupational therapist, licensed in the State, with a bachelor of science degree in occupational therapy from an accredited school of occupational therapy and 2 years experience, 1 of which shall have been in a mental health setting.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Other members of the hospital staff who work directly with the patient, including other professionals and paraprofessionals and professionals in service and in training.</text> </paragraph> </paragraph> <paragraph num="D."> <text>“Patient” means any person voluntarily or involuntarily admitted to one of the mental health facilities under the jurisdiction of, or licensed by, the Maryland Department of Health pursuant to the provisions of Health-General Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Content and Nature of Individual Treatment Plan."> <paragraph num="A."> <text>The individual treatment plan is a comprehensive and thoughtfully written plan based on an initial diagnostic impression and an overall evaluation of the patient's specific needs and problems. It includes an inventory of the patient's strengths as well as weaknesses, and sets forth short-term measurable goals and behaviorally stated objectives aimed at maximal restoration of the patient's adaptive capacity and return to the community as soon as possible. Based on the above goals objectives, a plan of active treatment shall be prescribed which aims at the arrest, reversal, and amelioration of the patient's illness symptoms. There shall be included a long-range discharge goal as well as an estimate of the probable length of inpatient stay needed before transfer to a less restrictive or intensive treatment milieu.</text> </paragraph> <paragraph num="B."> <text>The individual treatment plan shall be initially recorded and appropriately updated in the patient's permanent medical record.</text> </paragraph> <paragraph num="C."> <text>The initial individual treatment plan shall be developed by members of the mental health professional treatment team who are directly involved in the patient's care including at least one member each from Regulation .02C(1) and (2), of this chapter. The initial individual treatment plan shall be signed by the physician responsible for its development. The names of the other members of the mental health professional treatment team involved in the development of the plan shall be noted adjacent to the signature of the physician.</text> </paragraph> <paragraph num="D."> <text>A comprehensive, thoughtfully written, and properly signed individual treatment plan shall be recorded in the permanent medical record, or on a separate form which will become part of the permanent medical record, no later than 15 days after admission.</text> </paragraph> <paragraph num="E."> <text>The individual treatment plan shall include or refer to essential written or verbal information which has been gathered, as well as relevant information derived from other parts of the medical record, that will help identify the specific needs and problems of the individual patient. The individual treatment plan shall also include an initial psychiatric diagnosis recorded in the official nomenclature of the American Psychiatric Association, discharge planning data relating to community and financial resources available to the patient, and the legal status of the patient. Information may not be gathered without the consent of the patient or of the patient's parent or legally appointed representative if the patient is a minor or is incompetent.</text> </paragraph> <paragraph num="F."> <text>The individual treatment plan shall include a notation of any therapeutic task, labor, recreation, or other scheduled activity to be performed by the patient, including the rationale for these in relation to the treatment plan and the projected goals.</text> </paragraph> <paragraph num="G."> <text>The individual treatment plan shall include, when applicable, a description of the patient's individualized educational plan. Special education plans, in conformance with the regulations of the Department of Education, are mandatory for patients through 20 years old.</text> </paragraph> <paragraph num="H."> <text>The individual treatment plan shall include, when feasible, patient participation in accordance with Health-General Article, §10-706, Annotated Code of Maryland.</text> </paragraph> <paragraph num="I."> <text>Care shall be taken to preserve the confidentiality of the patient-mental health professional treatment team member relationship. Information from a patient's record, including the individual treatment plan, may not be disclosed to any person, organization, or agency except in the case of a court order or with the written consent of the patient or of the patient's parent, if the patient is a minor, or legally appointed representative, if the patient is incompetent.</text> </paragraph> <paragraph num="J."> <text>The individual treatment plan shall be periodically reassessed by members of the mental health professional treatment team who are working directly with the patient, including at least one member each from Regulation .02C(1) and (2), of this chapter, including the physician responsible for the implementation of the plan. This reassessment shall be made no less than once every 15 days for the first 2 months for all newly admitted or readmitted patients, and after that, at least once every 60 days.</text> </paragraph> <paragraph num="K."> <text>The mental health professional treatment team members who make the reassessment shall place a written entry in the permanent medical record or on a separate form which will become part of the permanent medical record. This entry shall be signed by the physician responsible for the implementation of the plan. The names of the other members of the mental health professional treatment team involved in the reassessment of the plan shall be noted adjacent to the signature of the physician.</text> </paragraph> <paragraph num="L."> <text>The initial individual treatment plan and all subsequent reassessments shall be easily identifiable as a separate, comprehensively written, and properly signed entry into the permanent medical record or on a separate form which will become part of the permanent medical record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Severability."> <text>If any section or provision of these regulations is declared unconstitutional or void by any court of competent jurisdiction, or its applicability to any person or circumstances is held invalid, the constitutionality or validity of the remainder of these regulations and their applicability to other persons and circumstances may not be affected, and, to this end, the sections and provisions of these regulations are declared to be severable.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-705, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 25, 1975 (2:14 Md. R. 1016)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.21.03 cited in Attorney General Opinion No. 82-034 (November 18, 1982)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 9, 1989 (15:27 Md. R. 3129)</annotation> </annotations> </chapter> <chapter num="04" heading="Community Mental Health Programs — Group Homes for Adults with Mental Illness"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the licensing procedure for group homes for adults with mental disorders.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </paragraph> <paragraph num="B."> <text>Definition of Group Home.</text> <paragraph num="(1)"> <text>“Group home” means a community-based residential program that provides services:</text> <paragraph num="(a)"> <text>For individuals who have been or are under treatment for a mental disorder;</text> </paragraph> <paragraph num="(b)"> <text>When possible, in the individual's community of origin; and</text> </paragraph> <paragraph num="(c)"> <text>In a home-like environment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Group home” means a private group home as defined in Health-General Article, §§10-514(b), (d) — (e) and 10-518(b), Annotated Code of Maryland, as either a:</text> <paragraph num="(a)"> <text>Small private group home, which:</text> <paragraph num="(i)"> <text>Admits at least four but not more than eight individuals; and</text> </paragraph> <paragraph num="(ii)"> <text>Is deemed conclusively a single-family residence and is permitted in all residential zones; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Large private group home, which:</text> <paragraph num="(i)"> <text>Admits at least nine but not more than 16 individuals; and</text> </paragraph> <paragraph num="(ii)"> <text>Is deemed conclusively a multifamily residence and is permitted in zones of similar density.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Group home” does not include a:</text> <paragraph num="(a)"> <text>Foster home that is the domicile of the foster parent; or</text> </paragraph> <paragraph num="(b)"> <text>Facility that is:</text> <paragraph num="(i)"> <text>Owned by or leased to the State or any public agency;</text> </paragraph> <paragraph num="(ii)"> <text>Regulated by the Department of Juvenile Services or Developmental Disabilities Administration; or</text> </paragraph> <paragraph num="(iii)"> <text>Organized wholly or partly to make a profit.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Admission Standards."> <paragraph num="A."> <text>A group home may admit an individual if the individual:</text> <paragraph num="(1)"> <text>Has a mental disorder;</text> </paragraph> <paragraph num="(2)"> <text>Because of the mental disorder, requires residential services for assistance and support in community living;</text> </paragraph> <paragraph num="(3)"> <text>Has the ability to understand and states, in writing, willingness to comply with the rules and regulations of the group home; and</text> </paragraph> <paragraph num="(4)"> <text>Is able to take appropriate action, under emergency conditions, for self-preservation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A group home may not admit an individual if the individual:</text> <paragraph num="(1)"> <text>Has a primary diagnosis of alcoholism, drug addition, or severe brain damage; or</text> </paragraph> <paragraph num="(2)"> <text>Shows current violent or antisocial behavior.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an individual is a Medicaid recipient or an individual for whom, because of the severity of the illness and financial need, the cost of care is subsidized through the public mental health system, the individual may be admitted to a group home only if the services are preauthorized by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.09.70.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Required."> <paragraph num="A."> <text>A person shall obtain a license from the Department before operating a group home.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall grant a license to an applicant to operate a group home, as described in Regulation .02 of this chapter, if the applicant fulfills the requirements for:</text> <paragraph num="(1)"> <text>Licensure under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Administrative requirements under COMAR 10.21.17;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric rehabilitation programs under COMAR 10.21.21; and</text> </paragraph> <paragraph num="(4)"> <text>Residential rehabilitation programs under COMAR 10.21.22.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Process."> <paragraph num="A."> <text>Consultation. Before submitting an application, an applicant for licensure to operate a group home may request assistance from the Department's designated licensure unit or the appropriate core service agency (CSA) regarding the proper compilation of application materials and completion of the application.</text> </paragraph> <paragraph num="B."> <text>Application for Licensure. An applicant for licensure for a group home shall:</text> <paragraph num="(1)"> <text>Submit, to the Department's designated licensure unit, a signed, notarized application on the form approved by the Department with the requirement that all questions be answered and all required documents be attached;</text> </paragraph> <paragraph num="(2)"> <text>Include in the application:</text> <paragraph num="(a)"> <text>The applicant's:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Agency affiliation, if any; and</text> </paragraph> <paragraph num="(iii)"> <text>Address;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Documentation:</text> <paragraph num="(i)"> <text>Of the applicant's not-for-profit status;</text> </paragraph> <paragraph num="(ii)"> <text>That the applicant has sufficient financial resources or that sufficient resources are available to the applicant for the establishment and operation of the residence;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The following information about the property:</text> <paragraph num="(i)"> <text>The street address of the property or, if it has no street address, a description that adequately identifies the location; and</text> </paragraph> <paragraph num="(ii)"> <text>If the applicant does not own the property, the name and address of the owner;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The satisfactory reports, not more than 1 year old, of the group home that are required by the local jurisdiction, including, at a minimum:</text> <paragraph num="(i)"> <text>A fire safety inspection report; and</text> </paragraph> <paragraph num="(ii)"> <text>In addition, for a large group home, a health inspection report;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Written material that describes how the applicant intends the program to comply with the:</text> <paragraph num="(i)"> <text>Requirements outlined in this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Administrative requirements outlined in COMAR 10.21.17; and</text> </paragraph> <paragraph num="(iii)"> <text>Programmatic and staffing requirements outlined in COMAR 10.21.21 and 10.21.22;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>When applicable, a letter of intent that explains how the proposed services meet a need identified in the Administration-approved CSA plan; and</text> </paragraph> <paragraph num="(g)"> <text>When applicable, documentation that the program will collaborate with the CSA, as required under COMAR 10.21.17.04;</text> </paragraph> <paragraph num="(h)"> <text>Documentation that the group home:</text> <paragraph num="(i)"> <text>Is compatible with the nature and character of the area involved;</text> </paragraph> <paragraph num="(ii)"> <text>Is near transportation facilities; and</text> </paragraph> <paragraph num="(iii)"> <text>Meets or, on completion, will meet general zoning requirements regarding size, density, land use, and architectural guidelines that apply to the location;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit with the application a copy of the residential specialist's certificate of approval of the residence, as granted under the provisions of COMAR 10.21.22; and</text> </paragraph> <paragraph num="(4)"> <text>Forward a copy of the:</text> <paragraph num="(a)"> <text>Application cover letter to the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Application to the:</text> <paragraph num="(i)"> <text>CSA, if the jurisdiction in which the program is to be located is served by a CSA; or</text> </paragraph> <paragraph num="(ii)"> <text>Health officer, if the jurisdiction in which the program is to be located is not served by a CSA.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Licensure."> <paragraph num="A."> <text>Initial License.</text> <paragraph num="(1)"> <text>Within 90 days of receipt of an application completed according to Regulation .05B of this chapter, the Department's designated licensure unit:</text> <paragraph num="(a)"> <text>Shall:</text> <paragraph num="(i)"> <text>Evaluate the application;</text> </paragraph> <paragraph num="(ii)"> <text>Meet with the applicant; and</text> </paragraph> <paragraph num="(iii)"> <text>Conduct an on-site review to inspect the physical plant and evaluate the proposed group home; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May ask the group home program director to submit a program improvement plan regarding deficiencies cited by the licensure unit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Based on the evaluation conducted under §A(1)(a) and the results of the plan under §A(1)(b) of this regulation, the Secretary shall either:</text> <paragraph num="(a)"> <text>Issue a license for a period of 2 years, if the group home:</text> <paragraph num="(i)"> <text>Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and</text> </paragraph> <paragraph num="(ii)"> <text>Complies with the requirements outlined in this chapter and COMAR 10.21.17, 10.21.21, and 10.21.22; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Propose to deny a license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Secretary takes the action in §A(2)(b) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal License.</text> <paragraph num="(1)"> <text>If a group home licensee proposes to continue to operate, the licensee shall file an application for renewal:</text> <paragraph num="(a)"> <text>At least 60 days before the expiration of the current license;</text> </paragraph> <paragraph num="(b)"> <text>With the Department's designated licensure unit, with copies to the CSA and the Administration; and</text> </paragraph> <paragraph num="(c)"> <text>On the form approved by the Department with the requirement that all questions be answered and all required documents be attached.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon receipt of an application for renewal, the Department's designated licensure unit:</text> <paragraph num="(a)"> <text>Shall conduct an on-site evaluation of the group home; and</text> </paragraph> <paragraph num="(b)"> <text>May ask the group home program director to submit a program improvement plan regarding deficiencies cited by the licensure unit.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Based on the evaluation under §B(2)(a) and the results of the plan under §B(2)(b) of this regulation, the Secretary shall either:</text> <paragraph num="(a)"> <text>Issue a license for a period of 2 years, if the group home:</text> <paragraph num="(i)"> <text>Has operated satisfactorily under the current license; and</text> </paragraph> <paragraph num="(ii)"> <text>Complies with the requirements outlined in this chapter and COMAR 10.21.17, 10.21.21, and 10.21.22; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Propose to deny a license.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Secretary takes the action in §B(3)(b) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Waivers and Variances.</text> <paragraph num="(1)"> <text>Waivers. The Secretary may not waive the requirements of any regulation adopted under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Variances.</text> <paragraph num="(a)"> <text>The Secretary may grant a variance to a regulation if the Secretary:</text> <paragraph num="(i)"> <text>Receives a written request from a program; and</text> </paragraph> <paragraph num="(ii)"> <text>Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Secretary may not grant a variance that would endanger the health or safety of the individuals served.</text> </paragraph> <paragraph num="(c)"> <text>The Secretary may grant a variance that:</text> <paragraph num="(i)"> <text>Remains in effect for as long as the program continues to comply with the conditions under which the variance is granted; or</text> </paragraph> <paragraph num="(ii)"> <text>Is time limited.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The Secretary shall issue a written decision, including the reason or reasons for granting or not granting the variance, and shall:</text> <paragraph num="(i)"> <text>Send the decision to the program for inclusion in the program's official file; and</text> </paragraph> <paragraph num="(ii)"> <text>Enter the decision in the records of the Department.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Deemed Status."> <paragraph num="A."> <text>Request for Deemed Status. If a group home is licensed by the Department and is accredited by the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) or the Rehabilitation Accreditation Commission (CARF), the governing body of the group home may request that the Secretary grant the group home deemed status by submitting a written request:</text> <paragraph num="(1)"> <text>At least 90 days before the expiration of the group home's license;</text> </paragraph> <paragraph num="(2)"> <text>To the:</text> <paragraph num="(a)"> <text>Administration;</text> </paragraph> <paragraph num="(b)"> <text>CSA, if the jurisdiction in which the program is to be located is served by a CSA; and</text> </paragraph> <paragraph num="(c)"> <text>Health officer, if the jurisdiction in which the program is to be located is not served by a CSA; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>That includes the:</text> <paragraph num="(a)"> <text>Application required under Regulation .05B of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Accreditation body's full report including the group home's status and any conditions placed on the group home.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Evaluation of Request for Deemed Status. Within 30 calendar days of receipt of the request under §A of this regulation:</text> <paragraph num="(1)"> <text>The Administration, in consultation with the CSA:</text> <paragraph num="(a)"> <text>Shall evaluate the:</text> <paragraph num="(i)"> <text>Application;</text> </paragraph> <paragraph num="(ii)"> <text>Report of the accreditation body; and</text> </paragraph> <paragraph num="(iii)"> <text>Most recent report by the Department's designated licensure unit;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May meet with the applicant; and</text> </paragraph> <paragraph num="(c)"> <text>May arrange for an on-site evaluation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Director shall recommend to the Secretary a decision regarding deemed status, based on:</text> <paragraph num="(a)"> <text>Comparison of the standards used by the accreditation body with the requirements outlined in COMAR 10.21.17, 10.21.21, 10.21.22, and this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The results of an on-site evaluation, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Decision Regarding Deemed Status. Based on the evaluation of the request for deemed status conducted under §B of this regulation, within 45 calendar days of completion of the evaluation, the Secretary shall:</text> <paragraph num="(1)"> <text>Decide, whether to:</text> <paragraph num="(a)"> <text>Grant deemed status;</text> </paragraph> <paragraph num="(b)"> <text>Grant deemed status with conditions, which may include evaluation by the Department's designated licensure unit; or</text> </paragraph> <paragraph num="(c)"> <text>Propose to deny deemed status; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Send notice of the proposed decision to the:</text> <paragraph num="(a)"> <text>Department's designated licensure unit;</text> </paragraph> <paragraph num="(b)"> <text>Governing body;</text> </paragraph> <paragraph num="(c)"> <text>Group home director;</text> </paragraph> <paragraph num="(d)"> <text>Administration; and</text> </paragraph> <paragraph num="(e)"> <text>As applicable, either the CSA director or health officer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Proposal to Deny Deemed Status.</text> <paragraph num="(1)"> <text>If the Secretary proposes to deny approval of deemed status, the Secretary shall give written notice of the proposed denial to those listed in §C(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>In the notice under §D(1) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date that the Secretary proposes to deny approval of deemed status;</text> </paragraph> <paragraph num="(b)"> <text>Location, including street address, to which the proposed denial applies;</text> </paragraph> <paragraph num="(c)"> <text>The facts that warrant the proposed denial; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that, before the denial, the program has a right to a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice under §D(2) of this regulation, the chairman of the governing body may:</text> <paragraph num="(a)"> <text>Withdraw the request for deemed status; and</text> </paragraph> <paragraph num="(b)"> <text>Request an on-site review for approval by the Department's designated licensure unit.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the governing body does not take the action under §D(3) of this regulation and if, after notice and opportunity to be heard, the Secretary denies approval of deemed status, the Director shall notify the governing body that, unless the program elects not to seek approval, the Department's designated approval unit shall conduct an on-site review for the purpose of granting or denying a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Program Inspection and Investigation by the Department."> <paragraph num="A."> <text>The Department may make announced and unannounced visits to a group home.</text> </paragraph> <paragraph num="B."> <text>If the Department receives information that the safety or welfare of an individual served is in jeopardy, the Department shall promptly:</text> <paragraph num="(1)"> <text>Conduct and document an investigation; and</text> </paragraph> <paragraph num="(2)"> <text>Based on the investigation under §B(1) of this regulation, take appropriate action, including:</text> <paragraph num="(a)"> <text>Outlining the requirements for the group home to correct the problems identified; or</text> </paragraph> <paragraph num="(b)"> <text>Initiating any of the following:</text> <paragraph num="(i)"> <text>Emergency suspension, under the provisions of Regulation .09B of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Disciplinary action, including suspension, revocation, probation, or banning new admissions under the provisions of Regulation .09C of this chapter; or</text> </paragraph> <paragraph num="(iii)"> <text>Receivership, under the provisions of Regulation .11 of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Denial and Emergency Suspension of Licensure and Disciplinary Action."> <paragraph num="A."> <text>Denial of License.</text> <paragraph num="(1)"> <text>If the Secretary proposes to deny a license to an applicant under the provisions of this chapter, the Secretary shall give written notice of the proposed denial to the:</text> <paragraph num="(a)"> <text>Chairman of the governing body;</text> </paragraph> <paragraph num="(b)"> <text>Program director;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>As applicable, either the CSA director or the health officer.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the notice under §A(1) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date on which the Secretary proposes to deny the license;</text> </paragraph> <paragraph num="(b)"> <text>Location, including street address, to which the proposed denial applies;</text> </paragraph> <paragraph num="(c)"> <text>The facts that warrant the proposed denial of the license;</text> </paragraph> <paragraph num="(d)"> <text>Citation of the regulation or regulations upon which the proposed denial is based; and</text> </paragraph> <paragraph num="(e)"> <text>Notification that, before the deprivation of a license, the group home may request a hearing under the provisions of Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If, after notice and opportunity to be heard, the Secretary denies a license to a group home, the governing body shall assure that, within 10 working days, the program director:</text> <paragraph num="(a)"> <text>Notifies the residents in the group home of the denial;</text> </paragraph> <paragraph num="(b)"> <text>When appropriate, notifies the CSA or the Administration of the denial and cooperates with the CSA or the Administration in accessing appropriate alternate housing for individuals in the group home; and</text> </paragraph> <paragraph num="(c)"> <text>Ceases operations of the group home.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Suspension of License.</text> <paragraph num="(1)"> <text>Pursuant to State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a group home, the Secretary may order the immediate suspension of the license of the group home and the cessation of operations.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary takes the action under §B(1) of this regulation, the Secretary shall promptly give written notice of the proposed emergency suspension to the:</text> <paragraph num="(a)"> <text>Chairman of the governing body;</text> </paragraph> <paragraph num="(b)"> <text>Program director;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>As applicable, either the CSA director or the health officer.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the notice under §B(2) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The effective date of the emergency suspension;</text> </paragraph> <paragraph num="(b)"> <text>Location, including street address, to which the emergency suspension applies;</text> </paragraph> <paragraph num="(c)"> <text>The findings under §B(1) of this regulation and the reasons that support the findings;</text> </paragraph> <paragraph num="(d)"> <text>Notification that:</text> <paragraph num="(i)"> <text>Following the emergency suspension, the group home may request a hearing under the provisions of Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>The emergency suspension may lead to revocation of the license if the violation or violations are not corrected within the time period specified by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Secretary suspends the license, the governing body shall assure that the program director immediately takes the action described under §A(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Disciplinary Action.</text> <paragraph num="(1)"> <text>The Secretary may propose to take any of the following disciplinary actions against the license to operate a group home:</text> <paragraph num="(a)"> <text>Revocation;</text> </paragraph> <paragraph num="(b)"> <text>Suspension;</text> </paragraph> <paragraph num="(c)"> <text>Probation, with conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Banning new admissions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may propose to take one of the actions outlined in §C(1) of this regulation if the group home:</text> <paragraph num="(a)"> <text>Is out of compliance with the requirements of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Obtains or attempts to obtain licensure by fraud, misrepresentation, or the submission of false information to the Secretary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 45 calendar days in advance of the proposed action taken under this regulation, the Secretary shall send written notice of the proposed action to the:</text> <paragraph num="(a)"> <text>Chairman of the governing body;</text> </paragraph> <paragraph num="(b)"> <text>Program director;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>As applicable, either the CSA director or the health officer.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the notice under §C(3) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date on which the Secretary proposes to take action against the license;</text> </paragraph> <paragraph num="(b)"> <text>Location, including street address, to which the proposed action applies;</text> </paragraph> <paragraph num="(c)"> <text>The facts that warrant the proposed action;</text> </paragraph> <paragraph num="(d)"> <text>Citation of the regulation or regulations upon which the proposed action is based; and</text> </paragraph> <paragraph num="(e)"> <text>Notification that, before the action, the group home has the right to request a hearing under the provisions of Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, after notice and opportunity to be heard, the Secretary takes disciplinary action, the governing body shall assure that, within 10 working days, the program director takes the action described under §A(3) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Group Home Request."> <text>If a group home requests that licensure be discontinued:</text> <paragraph num="A."> <text>The Secretary shall discontinue licensure; and</text> </paragraph> <paragraph num="B."> <text>The governing body shall assure that, within 10 working days, the program director takes the action described under Regulation .09A(3) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Initiation of Receivership."> <text>The Secretary may take action to initiate receivership under the provisions of Health-General Article, §§19-333 — 19-339, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Procedures for Hearings."> <paragraph num="A."> <text>Within 10 working days of receipt of notification that the Secretary proposes to deny approval or initiate disciplinary action, the chairman of the governing body may file a written request for a hearing with the Office of Administrative Hearings, with copies to the:</text> <paragraph num="(1)"> <text>Administration;</text> </paragraph> <paragraph num="(2)"> <text>CSA director; and</text> </paragraph> <paragraph num="(3)"> <text>Director of the Department's designated licensure unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the chairman of the governing body does not file a request for hearing that is post-marked within 10 working days of receipt of the notification, the group home waives the right to request a hearing, and the Secretary may effect the proposed action.</text> </paragraph> <paragraph num="C."> <text>If a timely request for hearing has been received, the Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Notify the director and the chairman of the governing body of the date, time, and location of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Hold a hearing and render a proposed decision to the Secretary in accordance with COMAR 28.02.01.</text> </paragraph> </paragraph> <paragraph num="D."> <text>After giving parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice of the decision to the:</text> <paragraph num="(1)"> <text>Director; and</text> </paragraph> <paragraph num="(2)"> <text>Chairman of the governing body.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Further Appeal. A group home may appeal any final decision by the Secretary by following the provisions of Health-General Article, §10-524, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-514 — 10-524 and 10-604, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 25, 1980 (7:15 Md. R. 1424)</annotation> <annotation type="History" subtype="Administrative History">Recodified from COMAR 10.21.05 to 10.21.04</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 14, 1991 (18:20 Md. R. 2199)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Group Homes for the Mentally Disabled, repealed and new Chapter, Community Mental Health Programs — Group Homes for Adults with Mental Illness, adopted effective October 5, 1998 (25:20 Md. R. 1529)</annotation> </annotations> </chapter> <chapter num="05" heading="Aftercare Plans"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to aftercare plans, which are:</text> <paragraph num="A."> <text>Provided to an individual who has been accepted under the provisions of Health-General Article, Title 10, Subtitle 6, Health-General Article, Title 12, Subtitle 1, or Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland, in one of the following:</text> <paragraph num="(1)"> <text>Mental Hygiene Administration facility under Health-General Article, §10-406, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Private psychiatric inpatient facility;</text> </paragraph> <paragraph num="(3)"> <text>Residential treatment center for children and adolescents; or</text> </paragraph> <paragraph num="(4)"> <text>Psychiatric unit in an acute care general hospital; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Designed to:</text> <paragraph num="(1)"> <text>Enhance the opportunity for the individual to live in the community; and</text> </paragraph> <paragraph num="(2)"> <text>Assist in the prevention of homelessness.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accepted” means:</text> <paragraph num="(a)"> <text>Taken into confinement on the basis of an application and certificate for involuntary admission, according to the provisions of Health-General Article, §§10-614 — 10-616, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Admitted, as defined in §B(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative services organization (ASO)” means the organization under contract with the Administration to provide administrative services for the public mental health system.</text> </paragraph> <paragraph num="(4)"> <text>“Admitted” means:</text> <paragraph num="(a)"> <text>Admitted voluntarily, according to the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Admitted involuntarily, by an administrative law judge, according to the provisions of Health-General Article, §10-632, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Committed by a court according to the provisions of:</text> <paragraph num="(i)"> <text>Health-General Article, Title 12, Subtitle 1, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Aftercare plan” means the plan developed by inpatient facility staff according to the requirements of Health-General Article, §10-809, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Chief executive officer (CEO)” means the individual responsible for the overall management of a facility.</text> </paragraph> <paragraph num="(7)"> <text>“Discharge” means authorization by a physician for a voluntarily or involuntarily admitted individual to leave an inpatient facility.</text> </paragraph> <paragraph num="(8)"> <text>“Proper consent” means consent given by the individual, or, if the individual is a child or adolescent, by the individual's parent or guardian, to release relevant information.</text> </paragraph> <paragraph num="(9)"> <text>“Release” means the authorization for an individual who is confined in an inpatient facility on the basis of an application and certificate for involuntary admission to leave the inpatient facility:</text> <paragraph num="(a)"> <text>Given by a physician during the observation status period; or</text> </paragraph> <paragraph num="(b)"> <text>Ordered by an administrative law judge at an involuntary admissions hearing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Content and Nature of Aftercare Plans."> <paragraph num="A."> <text>Staff designated by the CEO to assist individuals in aftercare planning shall, as soon as possible after acceptance, in collaboration with the individual:</text> <paragraph num="(1)"> <text>Initiate the aftercare planning process;</text> </paragraph> <paragraph num="(2)"> <text>With proper consent, involve in the aftercare planning process:</text> <paragraph num="(a)"> <text>Community-based service providers;</text> </paragraph> <paragraph num="(b)"> <text>Family members;</text> </paragraph> <paragraph num="(c)"> <text>Others who have a personal interest in the individual; and</text> </paragraph> <paragraph num="(d)"> <text>Third-party payors, including Medical Assistance, the Administration's ASO, or private insurance carriers, if involved, for authorization of outpatient services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assist in applying for benefits to which the individual may be entitled and document the outcome of the benefits application process in the individual's record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before discharge or release, designated staff shall:</text> <paragraph num="(1)"> <text>Provide notification of the discharge or release:</text> <paragraph num="(a)"> <text>With proper consent, to:</text> <paragraph num="(i)"> <text>The individual's next-of-kin;</text> </paragraph> <paragraph num="(ii)"> <text>As appropriate, the core service agency (CSA);</text> </paragraph> <paragraph num="(iii)"> <text>Community-based treatment and support services providers rendering services before the individual's inpatient admission; and</text> </paragraph> <paragraph num="(iv)"> <text>Third-party payors, including Medical Assistance, the Administration's ASO, or private insurance carriers, if involved, for authorization of outpatient services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the individual is a minor, to the parent or guardian; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assist the individual to participate in the aftercare plan by:</text> <paragraph num="(a)"> <text>Explaining to the individual the benefits of:</text> <paragraph num="(i)"> <text>The aftercare plan;</text> </paragraph> <paragraph num="(ii)"> <text>Community-based treatment and support services; and</text> </paragraph> <paragraph num="(iii)"> <text>The involvement of family or others who have a personal interest in the individual;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Encouraging the individual to consent to the aftercare plan; and</text> </paragraph> <paragraph num="(c)"> <text>Arranging appointments for the individual with appropriate community programs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In collaboration with community programs and government agencies that have agreed to provide aftercare services to the individual after discharge or release, designated staff shall prepare a written aftercare plan that includes:</text> <paragraph num="(1)"> <text>The individual's:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(c)"> <text>Address and telephone number upon discharge or release;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a minor or an individual under guardianship, the name, address, and telephone number of the custodial adult or guardian;</text> </paragraph> <paragraph num="(3)"> <text>If the individual will reside in program-arranged housing, the name, address, telephone number, and contact person of the placement agency;</text> </paragraph> <paragraph num="(4)"> <text>The date and type of admission and discharge or release;</text> </paragraph> <paragraph num="(5)"> <text>The scheduled court date, if any;</text> </paragraph> <paragraph num="(6)"> <text>The diagnoses, including existing psychiatric, somatic, and dental diagnoses, and level of functional assessment;</text> </paragraph> <paragraph num="(7)"> <text>The type of treatment initiated;</text> </paragraph> <paragraph num="(8)"> <text>The name, address, and telephone number of the primary care provider;</text> </paragraph> <paragraph num="(9)"> <text>Medication information, including the:</text> <paragraph num="(a)"> <text>Medication prescribed;</text> </paragraph> <paragraph num="(b)"> <text>Dosage schedules;</text> </paragraph> <paragraph num="(c)"> <text>Amount of each medication given to the individual upon discharge or release; and</text> </paragraph> <paragraph num="(d)"> <text>Information necessary to help the individual to obtain the prescribed medication in the community;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The most recent laboratory results, including therapeutic drug levels;</text> </paragraph> <paragraph num="(11)"> <text>If applicable, a description of:</text> <paragraph num="(a)"> <text>Allergies, including medication allergies;</text> </paragraph> <paragraph num="(b)"> <text>Nutritional requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Active somatic problems requiring continued attention;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Information on the individual's medical insurance coverage, including the:</text> <paragraph num="(a)"> <text>Company;</text> </paragraph> <paragraph num="(b)"> <text>Policy number;</text> </paragraph> <paragraph num="(c)"> <text>Name of the policy holder; and</text> </paragraph> <paragraph num="(d)"> <text>Preauthorization information, if given, for services to be initiated upon discharge or release;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Entitlements, if any, and status;</text> </paragraph> <paragraph num="(14)"> <text>The plan for continuing treatment, including but not limited to:</text> <paragraph num="(a)"> <text>Outpatient mental health treatment services;</text> </paragraph> <paragraph num="(b)"> <text>Somatic care;</text> </paragraph> <paragraph num="(c)"> <text>Psychiatric rehabilitation and support services;</text> </paragraph> <paragraph num="(d)"> <text>When appropriate, substance abuse services; and</text> </paragraph> <paragraph num="(e)"> <text>Case management;</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>A list of additional referrals indicated, such as:</text> <paragraph num="(a)"> <text>Public social services;</text> </paragraph> <paragraph num="(b)"> <text>Legal aid;</text> </paragraph> <paragraph num="(c)"> <text>Educational services;</text> </paragraph> <paragraph num="(d)"> <text>Housing services;</text> </paragraph> <paragraph num="(e)"> <text>Vocational services;</text> </paragraph> <paragraph num="(f)"> <text>Peer support services; and</text> </paragraph> <paragraph num="(g)"> <text>Available crisis services; and</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Any identifying information required by the Administration's ASO.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Distribution of Aftercare Plan."> <paragraph num="A."> <text>Designated staff shall provide the individual with the opportunity to consent or withhold consent for release of all or any portion of the plan to any provider.</text> </paragraph> <paragraph num="B."> <text>Within 48 hours or by the first appointment, whichever is sooner, designated staff shall provide the aftercare plan, in accordance with the provisions of §A of this regulation, to the:</text> <paragraph num="(1)"> <text>Community treatment and support programs designated in the aftercare plan;</text> </paragraph> <paragraph num="(2)"> <text>Family members or others with a personal interest in the individual, if any, who are identified in the aftercare plan to provide housing; and</text> </paragraph> <paragraph num="(3)"> <text>Third-party payors, if involved, for authorization of outpatient services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Designated staff shall document in the individual's medical record who received information from the aftercare plan.</text> </paragraph> <paragraph num="D."> <text>If the individual does not consent to an aftercare plan, designated staff shall:</text> <paragraph num="(1)"> <text>Place in the individual's record a statement to this effect signed, when possible, by the individual, the individual's guardian, or, for a minor, the parent or guardian; and</text> </paragraph> <paragraph num="(2)"> <text>Provide to the individual, in writing, information on outpatient mental health clinics, crisis and emergency services, and other available community mental health services and resources within the jurisdiction in which the individual resides, and document in the individual's record what information was provided.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-709 and 10-809, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 14, 1998 (25:25 Md. R. 1831)</annotation> </annotations> </chapter> <chapter num="06" heading="Admission to Regional Institutes for Children and Adolescents"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes procedures and standards for residential admission to the Regional Institutes for Children and Adolescents (RICAs). The RICAs are mental health facilities licensed and operated by the Maryland Department of Health for the residential treatment of severely emotionally disturbed children and adolescents.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means a child or adolescent who is the subject of an application for admission to a RICA.</text> </paragraph> <paragraph num="(3)"> <text>“Director” means the Director of the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder and is referenced in Health-General Article, §10-620(e)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Resident” means a child or adolescent who is admitted to a RICA for residential treatment.</text> </paragraph> <paragraph num="(6)"> <text>“Residential treatment” means a program of active psychiatric treatment that is provided on a residential basis, under the direction of a psychiatrist, and in conformity with an individualized treatment plan.</text> </paragraph> <paragraph num="(7)"> <text>“RICA” means a Regional Institute for Children and Adolescents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Admission."> <paragraph num="A."> <text>On referral by a public or private agency or mental health professional, application for admission to a RICA may be made by:</text> <paragraph num="(1)"> <text>The parent or guardian of a child or adolescent under 18 years old;</text> </paragraph> <paragraph num="(2)"> <text>An adolescent, if the adolescent is 16 years old or older; or</text> </paragraph> <paragraph num="(3)"> <text>A State or county agency that has custody of a child or adolescent, with the signed consent of the parent or guardian or in accordance with a court order.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The admission application shall be on a form prescribed by the Administration and shall include:</text> <paragraph num="(1)"> <text>The name, date of birth, sex, legal domicile, and present residence of the applicant;</text> </paragraph> <paragraph num="(2)"> <text>A statement based on clinical evaluation by a mental health professional that the applicant has a long term and severe mental disorder and is in need of residential treatment; and</text> </paragraph> <paragraph num="(3)"> <text>A recent history of the applicant's psychiatric or psychological treatment, educational or special educational services, and involvement with community agencies.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Available medical records and psychiatric or psychological evaluations describing the applicant's mental disorder and need for residential treatment shall be attached to the admission application.</text> </paragraph> <paragraph num="D."> <text>The referring agency or mental health professional shall be responsible for assuring that appropriate written consent is obtained so as to permit that all required completed application materials may be sent to the RICA.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Admission Procedures."> <paragraph num="A."> <text>Each RICA shall maintain an admission team which consists of a physician, mental health and educational professionals and other persons, as appropriate. The RICA admission team shall determine whether the applicant meets the admission standards set forth in Regulation .05 of this chapter, within 10 working days of receipt of the completed application.</text> </paragraph> <paragraph num="B."> <text>The applicant and referring agency or mental health professional shall be notified by the RICA admission team as to whether the applicant meets the admission criteria.</text> </paragraph> <paragraph num="C."> <text>If the admission team determines that the admission criteria are met, a pre-admission interview shall be scheduled by the RICA at the earliest convenient date for all parties involved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Admission Criteria."> <paragraph num="A."> <text>A child or adolescent may be admitted to a RICA if the:</text> <paragraph num="(1)"> <text>Individual has a long-term and severe mental disorder;</text> </paragraph> <paragraph num="(2)"> <text>Individual has treatment needs that cannot be met through available community-based programs;</text> </paragraph> <paragraph num="(3)"> <text>Residential treatment provided by the RICA can reasonably be expected to improve the individual's condition or prevent further regression so that the individual can return to the community.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The child or adolescent shall be between 12 and 17 years old at the time of admission. The RICA admission team may waive the age limit in appropriate cases.</text> </paragraph> <paragraph num="C."> <text>A RICA may not admit a child or adolescent who has:</text> <paragraph num="(1)"> <text>A primary diagnosis of alcoholism, drug addiction, or severe brain damage; or</text> </paragraph> <paragraph num="(2)"> <text>Cognitive deficits which severely limit the individual's ability to use the treatment modalities provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A child or adolescent who otherwise meets the admission standards may not be denied residential treatment solely because the individual resides outside the regular catchment area served by the RICA, as established by the Director. The Director shall take into consideration the ratio of residential treatment beds to population base and proximity to the program when establishing the catchment areas, and shall review and revise the catchment areas, as appropriate, every 5 years beginning in 1990. Priority for admission shall be given to applicants living in the catchment area served by the RICA.</text> </paragraph> <paragraph num="E."> <text>If a child or adolescent meets the admission standards but the RICA is occupied to its licensed capacity, priority on the waiting list for admission shall be given to those individuals who have the most severe mental disorders as exhibited by level of dysfunctions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Resident Rights."> <paragraph num="A."> <text>Residents shall be accorded the rights enumerated in the Health-General Article, §§10-701 through 10-709, Annotated Code of Maryland, and shall be informed of these rights upon admission.</text> </paragraph> <paragraph num="B."> <text>An individualized treatment plan shall be developed and implemented for each resident in accordance with Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03.</text> </paragraph> <paragraph num="C."> <text>An educational program shall be provided for each resident based on educational needs and shall include, when appropriate, an individualized educational program in accordance with COMAR 13A.05.01.</text> </paragraph> <paragraph num="D."> <text>An aftercare plan shall be developed for each resident before release from a RICA in cooperation with the referring agency or professional, parent, or guardian or other appropriate agencies in accordance with the Health-General Article, §§10-709 and 10-809, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Court Evaluation Unit."> <paragraph num="A."> <text>A RICA may establish a separate unit for short term evaluation of children and adolescents referred by a Juvenile Court.</text> </paragraph> <paragraph num="B."> <text>Admission from the court evaluation unit to the regular residential treatment program shall be in accordance with the procedures and standards set forth in Regulations .04 and .05 of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 10-204, 10-401, 10-406, 10-407, 10-602, 10-609, and 10-610, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1985 (12:9 Md. R. 811)</annotation> </annotations> </chapter> <chapter num="07" heading="Therapeutic Group Homes"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the procedures and standards for operating, programming, and staffing a therapeutic group home (TGH) for children.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 14.31.05, 14.31.06, and in this chapter.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Case coordinator” means the mental health professional or residential care specialist supervised by a mental health professional who coordinates the services, as outlined in a child's TGH individual treatment plan (ITP), to the child.</text> </paragraph> <paragraph num="(3)"> <text>“Clinical coordinator” means the mental health professional who is responsible for oversight of the clinical services provided to children in a TGH.</text> </paragraph> <paragraph num="(4)"> <text>“Contact note” means an entry that:</text> <paragraph num="(a)"> <text>Is made in an individual's medical record by a program staff member; and</text> </paragraph> <paragraph num="(b)"> <text>Describes face-to-face, written, or telephone contact with or regarding the individual.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Core service agency (CSA)” means the county or multi-county authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Governor’s Office for Children (GOC)” means the office created under Executive Order 01.01.2005.34.</text> </paragraph> <paragraph num="(8)"> <text>“Group home” means a private group home, as defined in Health-General Article, §10-514, Annotated Code of Maryland, that provides mental health services in a residential facility.</text> </paragraph> <paragraph num="(9)"> <text>“Managed care organization (MCO)” means a health care organization, as defined in Health-General Article, §15-101(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Medical record” means a record as defined in Health-General Article, §4-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Mental health professional” means:</text> <paragraph num="(a)"> <text>A psychiatrist; or</text> </paragraph> <paragraph num="(b)"> <text>An individual who is authorized by the Health Occupations Article, Annotated Code of Maryland, to provide the service for which the individual is privileged.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Primary caretaker” means the:</text> <paragraph num="(a)"> <text>Child's custodial parent or parents;</text> </paragraph> <paragraph num="(b)"> <text>Adult with whom the child currently resides; or</text> </paragraph> <paragraph num="(c)"> <text>Legal guardian.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Privileging” means the process by which a program determines that staff members are qualified to perform assigned duties.</text> </paragraph> <paragraph num="(14)"> <text>“Progress summary note” means an entry by an individual's treatment coordinator in the individual's medical record and that describes the individual's progress toward the goals delineated in the individual's ITP.</text> </paragraph> <paragraph num="(15)"> <text>“Secretary” means the Secretary of Health, or the Secretary's designee.</text> </paragraph> <paragraph num="(16)"> <text>“Small private group home” means a residence as defined in Health-General Article, §§10-514(d) and (e) and 10-518(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>Therapeutic Group Home (TGH).</text> <paragraph num="(a)"> <text>“Therapeutic group home (TGH)” means a small private group home.</text> </paragraph> <paragraph num="(b)"> <text>“Therapeutic group home (TGH)” does not include a foster home that is the domicile of the foster parent.</text> </paragraph> <paragraph num="(c)"> <text>“Therapeutic group home (TGH)” does not include a facility that is:</text> <paragraph num="(i)"> <text>Owned by or leased to the State or any public agency;</text> </paragraph> <paragraph num="(ii)"> <text>Regulated by the Department of Juvenile Services, Department of Human Services, or Developmental Disabilities Administration; or</text> </paragraph> <paragraph num="(iii)"> <text>Organized wholly or partly to make a profit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Therapeutic milieu” means an environment that is clinically structured to provide mental health treatment in a place other than the individual's residence.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Proposal and Designation of Lead Agency."> <paragraph num="A."> <text>Proposal.</text> <paragraph num="(1)"> <text>An individual or organization that proposes to provide therapeutic living services for children in a TGH shall:</text> <paragraph num="(a)"> <text>Direct an initial inquiry for obtaining a license to the GOC, in accordance with COMAR 14.31.05.05; and</text> </paragraph> <paragraph num="(b)"> <text>Submit to GOC, in accordance with COMAR 14.31.05.05, a proposal describing the:</text> <paragraph num="(i)"> <text>Physical plant in which the children will reside; and</text> </paragraph> <paragraph num="(ii)"> <text>Program service plan, as described in Regulation .05C of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>GOC shall designate a lead agency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Lead Agency. If GOC designates the Department as lead agency, on receipt of the proposal submitted under §A of this regulation, the Secretary shall notify the Director of the Administration, who shall:</text> <paragraph num="(1)"> <text>Forward a copy of the proposal to:</text> <paragraph num="(a)"> <text>The CSA director, if appropriate; and</text> </paragraph> <paragraph num="(b)"> <text>The designated licensure unit of the Department; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 2 weeks, send the applicant the Department application form and instructions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License Required."> <paragraph num="A."> <text>Before operating a TGH, a person shall obtain a license from the Department under the provisions of this chapter and COMAR 14.31.05 for each TGH site in which children reside.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall grant a license to an applicant to operate a TGH if the applicant fulfills the requirements for:</text> <paragraph num="(1)"> <text>Licensure under COMAR 14.31.05; and</text> </paragraph> <paragraph num="(2)"> <text>Service and staffing under this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Process."> <paragraph num="A."> <text>Consultation. If the Administration is the designated lead agency, an applicant for licensure for a TGH, before submitting an application, may request assistance from the designated licensure unit of the Department, the appropriate CSA director, or the Administration regarding the proper compilation of application materials and completion of the application.</text> </paragraph> <paragraph num="B."> <text>Application. An applicant for licensure of a TGH shall:</text> <paragraph num="(1)"> <text>Submit, to the Department's designated licensure unit, a signed, notarized application on the form approved by the Department with the requirement that all questions be answered and all required documents be attached;</text> </paragraph> <paragraph num="(2)"> <text>Include in the application:</text> <paragraph num="(a)"> <text>The applicant's:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Agency affiliation, if any; and</text> </paragraph> <paragraph num="(iii)"> <text>Address;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Documentation:</text> <paragraph num="(i)"> <text>Of the applicant's not-for-profit status; and</text> </paragraph> <paragraph num="(ii)"> <text>That the applicant has sufficient financial resources or that sufficient resources are available to the applicant for the establishment and operation of the residence;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The following information about the property:</text> <paragraph num="(i)"> <text>The street address of the location of the TGH or, if it has no street address, a description that adequately identifies the location of the property; and</text> </paragraph> <paragraph num="(ii)"> <text>If the applicant does not own the property, the name and address of the owner;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The satisfactory fire, safety, and health inspection reports, not more than 1 year old, of the TGH that are required by the local jurisdiction;</text> </paragraph> <paragraph num="(e)"> <text>Written material that describes how the applicant intends to comply with the requirements outlined in:</text> <paragraph num="(i)"> <text>COMAR 14.31.05; and</text> </paragraph> <paragraph num="(ii)"> <text>This chapter;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>An explanation of the need for the TGH, including, if the jurisdiction in which the TGH is to be located is served by a CSA, a letter of intent that explains how the TGH meets a need identified in the Administration-approved CSA plan;</text> </paragraph> <paragraph num="(g)"> <text>When applicable, documentation that the TGH will collaborate with the CSA, as required under Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(h)"> <text>Documentation that the TGH:</text> <paragraph num="(i)"> <text>Is near transportation facilities, or has a plan for the provision of transportation services based on the individual's need; and</text> </paragraph> <paragraph num="(ii)"> <text>Meets, or on completion will meet, general zoning requirements regarding size, density, land use, and architectural guidelines that apply to the site; and</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>The applicant's program service plan, as outlined in §C of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Forward a copy of the:</text> <paragraph num="(a)"> <text>Application cover letter to the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Application to the:</text> <paragraph num="(i)"> <text>CSA, if the jurisdiction in which the TGH is to be located is served by a CSA; or</text> </paragraph> <paragraph num="(ii)"> <text>Administration, if the jurisdiction in which the TGH is to be located is not served by a CSA.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Program Service Plan (PSP). On the form approved by the Administration, as part of the application, a TGH shall submit a PSP that includes:</text> <paragraph num="(1)"> <text>If appropriate, a copy of the articles of incorporation, organizational chart, bylaws, and list of the members, including officers, of the governing body;</text> </paragraph> <paragraph num="(2)"> <text>Documentation that at least 1/3 of the members of either the governing body or an advisory committee includes representation of consumers, former consumers, or family members;</text> </paragraph> <paragraph num="(3)"> <text>The proposed budget for the TGH;</text> </paragraph> <paragraph num="(4)"> <text>A description of:</text> <paragraph num="(a)"> <text>The number of children, as well as their age groups and other relevant characteristics, that the TGH expects to serve;</text> </paragraph> <paragraph num="(b)"> <text>The geographic area to be served;</text> </paragraph> <paragraph num="(c)"> <text>The goals, objectives, and expected outcomes of the program;</text> </paragraph> <paragraph num="(d)"> <text>The plan for the provision of the following services:</text> <paragraph num="(i)"> <text>Medical;</text> </paragraph> <paragraph num="(ii)"> <text>Dental;</text> </paragraph> <paragraph num="(iii)"> <text>Required education;</text> </paragraph> <paragraph num="(iv)"> <text>Social and recreational;</text> </paragraph> <paragraph num="(v)"> <text>Nutritional; and</text> </paragraph> <paragraph num="(vi)"> <text>Mental health treatment;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The method for linkage with service providers and community resources, including, when applicable, written agreements with inpatient facilities and other providers of health, mental health, and social services; and</text> </paragraph> <paragraph num="(f)"> <text>The methods by which quality, including risk management and utilization review, are assured; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A list of staff positions, their job descriptions and educational and clinical training requirements, and staffing patterns, including an organizational chart detailing lines of authority and responsibility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Governance."> <paragraph num="A."> <text>Governing Body.</text> <paragraph num="(1)"> <text>A provider that is licensed by the Department under this chapter to operate a TGH shall be governed by a body that shall:</text> <paragraph num="(a)"> <text>Carry out the responsibilities under COMAR 14.31.06.04; and</text> </paragraph> <paragraph num="(b)"> <text>Either:</text> <paragraph num="(i)"> <text>Include the membership described under §B(1) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>Appoint an advisory committee for the TGH that includes the membership described under §B(1) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The chairman of the governing body shall maintain documentation of:</text> <paragraph num="(a)"> <text>The legal form of organization of the operator of the TGH;</text> </paragraph> <paragraph num="(b)"> <text>The minutes of all regularly scheduled meetings; and</text> </paragraph> <paragraph num="(c)"> <text>Any registration required by the State Department of Assessments and Taxation to operate as a business in Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Advisory Committee.</text> <paragraph num="(1)"> <text>When appointing an advisory committee under §A(1)(b)(ii) of this regulation, the governing body shall assure that the committee is composed of members:</text> <paragraph num="(a)"> <text>That reflect the cultural and ethnic profile of the community or communities being served; and</text> </paragraph> <paragraph num="(b)"> <text>At least 1/3 of whom are individuals who are:</text> <paragraph num="(i)"> <text>Currently or were previously served by a TGH or other community-based mental health program;</text> </paragraph> <paragraph num="(ii)"> <text>Family members of individuals who are currently or were previously served by a TGH or other community-based mental health program; or</text> </paragraph> <paragraph num="(iii)"> <text>Members of a mental health advocacy organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An advisory committee appointed under §B(1) of this regulation shall, at a minimum:</text> <paragraph num="(a)"> <text>Establish and maintain a regular meeting schedule; and</text> </paragraph> <paragraph num="(b)"> <text>Advise the governing body regarding the duties described under COMAR 14.31.06.04.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Collaboration with Core Service Agency (CSA)."> <paragraph num="A."> <text>If the jurisdiction in which a TGH is located is served by a CSA, the governing body shall document that the program shall:</text> <paragraph num="(1)"> <text>Submit the following information to the CSA:</text> <paragraph num="(a)"> <text>Documentation that the program budget is adequate to support the program's ability to provide authorized services;</text> </paragraph> <paragraph num="(b)"> <text>The program service plan;</text> </paragraph> <paragraph num="(c)"> <text>Data that incorporate outcome measures; and</text> </paragraph> <paragraph num="(d)"> <text>A yearly summary that, at a minimum, includes:</text> <paragraph num="(i)"> <text>Relevant financial statements or documentation of an audit that certifies that the TGH is fiscally sound;</text> </paragraph> <paragraph num="(ii)"> <text>Program planning and evaluation, as identified in COMAR 14.31.06.19; and</text> </paragraph> <paragraph num="(iii)"> <text>Service utilization data;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Collaborate with the CSA in:</text> <paragraph num="(a)"> <text>The process developed by the CSA for screening and exploring alternatives for an individual served by the TGH for whom inpatient facility admission is being initiated;</text> </paragraph> <paragraph num="(b)"> <text>The CSA's protocol for resolution of conflict between the TGH and:</text> <paragraph num="(i)"> <text>The child or family of a child served; and</text> </paragraph> <paragraph num="(ii)"> <text>Another program or agency; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The CSA's procedures for prevention of the appearance or occurrence of conflict of interest in the operation and oversight of the program's provision of mental health services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Contract, as necessary, with the CSA; and</text> </paragraph> <paragraph num="(4)"> <text>Make available to the CSA any medical records that are needed by the CSA for the purpose of:</text> <paragraph num="(a)"> <text>Assessing the quality of care; or</text> </paragraph> <paragraph num="(b)"> <text>Investigating a complaint or grievance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the jurisdiction in which a TGH is located is not served by a CSA, the chairman of the governing body shall document that the program shall submit information to and collaborate with the Administration, as required under this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="TGH Program Model."> <paragraph num="A."> <text>A TGH provides therapeutic living services:</text> <paragraph num="(1)"> <text>For at least four but not more than eight children;</text> </paragraph> <paragraph num="(2)"> <text>By providing access to a combination of developmental, diagnostic, and therapeutic mental health services;</text> </paragraph> <paragraph num="(3)"> <text>When possible, in the child's community of origin; and</text> </paragraph> <paragraph num="(4)"> <text>In a home-like environment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The chief executive officer of a TGH shall assure that a TGH:</text> <paragraph num="(1)"> <text>Provides to each child in the TGH mental health care and treatment:</text> <paragraph num="(a)"> <text>That can reasonably be expected to benefit the child; and</text> </paragraph> <paragraph num="(b)"> <text>By an adequate staff or, under agreement, by a provider of mental health services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has sufficient staff to provide adequate supervision to the children in the TGH, including 24-hour supervision for each resident not participating in a program outside the TGH; and</text> </paragraph> <paragraph num="(3)"> <text>Coordinates treatment in the TGH with the appropriate public or nonpublic educational program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The chief executive officer of the TGH shall assure that services are:</text> <paragraph num="(1)"> <text>Appropriate to the cultural and psychosocial developmental needs of the child;</text> </paragraph> <paragraph num="(2)"> <text>Provided by staff who:</text> <paragraph num="(a)"> <text>As determined by the program, are appropriately credentialed and privileged; and</text> </paragraph> <paragraph num="(b)"> <text>Organize and manage the therapeutic milieu to:</text> <paragraph num="(i)"> <text>Foster clinically appropriate social, cognitive, emotional, and physical growth;</text> </paragraph> <paragraph num="(ii)"> <text>Handle aggression in a nonpunitive manner that promotes growth and learning;</text> </paragraph> <paragraph num="(iii)"> <text>Reinforce the child's ability to function with peers in a social environment;</text> </paragraph> <paragraph num="(iv)"> <text>Model and provide opportunities for children to behave in age-appropriate ways, such as assuming responsibility for carrying out routine activities, exhibiting independence and initiative in planning their own activities, getting along with others, and demonstrating age-appropriate social skills;</text> </paragraph> <paragraph num="(v)"> <text>Facilitate the child's awareness of appropriate behavior in a predictable, constructive, and timely manner; and</text> </paragraph> <paragraph num="(vi)"> <text>Help children to make choices and to negotiate disagreements among themselves, rather than resolving conflicts for them;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provided in an environment that is:</text> <paragraph num="(a)"> <text>Consistent with existing standards of program design; and</text> </paragraph> <paragraph num="(b)"> <text>Organized consistent with the learning styles and developmental needs of the child; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Designed to foster positive relationships between the child and the child's parents or guardians and, if other than a parent, the child's primary caretaker, and the anticipated post-placement caretaker.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Eligibility, Application, and Admission."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>A child is eligible for admission to a TGH if:</text> <paragraph num="(a)"> <text>The child:</text> <paragraph num="(i)"> <text>Has a mental disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Is or should be receiving treatment for the mental disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Because of the mental disorder, requires residential services not available in the home;</text> </paragraph> <paragraph num="(iv)"> <text>Needs 24-hour supervision in a structured private group home;</text> </paragraph> <paragraph num="(v)"> <text>Has the ability to understand and states, in writing, a willingness to comply with the rules and regulations of the TGH; and</text> </paragraph> <paragraph num="(vi)"> <text>Has the ability to act appropriately under emergency conditions; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>There is no less restrictive form of treatment that is consistent with the welfare and safety of the child.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A TGH may not admit or retain as a resident a child if the child:</text> <paragraph num="(a)"> <text>Has a primary diagnosis of alcoholism, drug addiction, or severe brain damage;</text> </paragraph> <paragraph num="(b)"> <text>Shows current violent or antisocial behavior; or</text> </paragraph> <paragraph num="(c)"> <text>Has cognitive deficits that severely limit the child's ability to benefit from the treatment modalities provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Application for Admission. An applicant to a TGH shall use an application form which outlines the following requirements:</text> <paragraph num="(1)"> <text>Identifying data, including but not limited to:</text> <paragraph num="(a)"> <text>Name, date of birth, sex, legal domicile, and current residence of the child;</text> </paragraph> <paragraph num="(b)"> <text>Names, addresses, and telephone numbers of persons or agencies having legal care or custody of the child; and</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the child's custody status, including, if relevant, documentation of agreements regarding responsibility for financial support and health care;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Authorization to release information signed by the child's parent or guardian;</text> </paragraph> <paragraph num="(3)"> <text>Based on a comprehensive mental health assessment by an individual authorized, under Health Occupations Article, Annotated Code of Maryland, to formulate a psychiatric diagnosis, a statement including:</text> <paragraph num="(a)"> <text>The psychiatric diagnosis and the rationale for the diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>An explanation of why the child would benefit from the treatment and related services provided in and by a TGH;</text> </paragraph> <paragraph num="(c)"> <text>The treatment goals for the child, if TGH placement occurs;</text> </paragraph> <paragraph num="(d)"> <text>Any history of violence or trauma, and the potential for current violent behavior; and</text> </paragraph> <paragraph num="(e)"> <text>Documentation that the child meets the eligibility criteria outlined in §A of this regulation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A recent history of the child's:</text> <paragraph num="(a)"> <text>Mental health treatment, including relevant psychiatric and psychological evaluations;</text> </paragraph> <paragraph num="(b)"> <text>Family status;</text> </paragraph> <paragraph num="(c)"> <text>Education, including documentation of a handicapping condition, if any; and</text> </paragraph> <paragraph num="(d)"> <text>Involvement, if any, with community agencies;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Relevant medical records; and</text> </paragraph> <paragraph num="(6)"> <text>Unless the child has a guardian that is a State agency, a written and signed statement that, at the time of application for admission, the child's parent or guardian:</text> <paragraph num="(a)"> <text>Agrees to the placement;</text> </paragraph> <paragraph num="(b)"> <text>Agrees to the rules and regulations of the TGH; and</text> </paragraph> <paragraph num="(c)"> <text>Enters into an agreement regarding the responsibility for payment for the child's medical and mental health care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If, under §B(3) of this regulation, the child has a history of violent behavior, TGH staff shall be permitted to plan and collaborate with the clinical referral source to develop a treatment plan which addresses the current potential for violent behavior.</text> </paragraph> <paragraph num="D."> <text>Admissions Procedures.</text> <paragraph num="(1)"> <text>An applicant for admission of a child to a TGH shall:</text> <paragraph num="(a)"> <text>Submit an application for admission, as described in §B of this regulation, to the TGH chief executive officer; and</text> </paragraph> <paragraph num="(b)"> <text>Forward copies of the application to the Administration and the CSA, if the jurisdiction in which the child's parent or guardian resides is served by a CSA.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On receipt of an application for admission to the TGH, the TGH chief executive officer, in collaboration with appropriate TGH mental health professional staff, may conduct a pre-admission interview with:</text> <paragraph num="(a)"> <text>The applicant for admission to a TGH;</text> </paragraph> <paragraph num="(b)"> <text>If other than the applicant, the:</text> <paragraph num="(i)"> <text>Child;</text> </paragraph> <paragraph num="(ii)"> <text>Child's parent or guardian; or</text> </paragraph> <paragraph num="(iii)"> <text>Referring agency; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>As appropriate, past or current providers of the following services:</text> <paragraph num="(i)"> <text>Educational;</text> </paragraph> <paragraph num="(ii)"> <text>Social; and</text> </paragraph> <paragraph num="(iii)"> <text>Mental health treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 2 weeks of receipt of an application for admission, the TGH chief executive officer shall:</text> <paragraph num="(a)"> <text>In consultation with clinical and residential staff at the TGH and based on the eligibility criteria outlined under §A of this regulation, determine whether the TGH is the appropriate setting for the child;</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the determination;</text> </paragraph> <paragraph num="(c)"> <text>If the determination is that the TGH is not appropriate for the child, notify the applicant of:</text> <paragraph num="(i)"> <text>The reason for the determination; and</text> </paragraph> <paragraph num="(ii)"> <text>A recommendation regarding the appropriate level of care; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Notify the appropriate CSA director and the Administration of the determination.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the TGH chief executive officer approves the application for admission, the chief executive officer shall give to the applicant written notice of:</text> <paragraph num="(a)"> <text>If a bed is available, the date of admission to the TGH; or</text> </paragraph> <paragraph num="(b)"> <text>If a bed is not available within the following 21 days:</text> <paragraph num="(i)"> <text>The child's position on the TGH's waiting list;</text> </paragraph> <paragraph num="(ii)"> <text>The process for reviewing the child's waiting list status; and</text> </paragraph> <paragraph num="(iii)"> <text>Information about appropriate placement alternatives.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Required Services."> <text>The chief executive officer of a TGH shall assure that children in the TGH receive:</text> <paragraph num="A."> <text>Physical and dental examinations, care, and treatment for children who are:</text> <paragraph num="(1)"> <text>Eligible for Medical Assistance, services through the managed care organization, as required by COMAR 10.09.67; or</text> </paragraph> <paragraph num="(2)"> <text>Not eligible for Medical Assistance, through written agreements with appropriate providers, as indicated under COMAR 01.04.04.19;</text> </paragraph> </paragraph> <paragraph num="B."> <text>From an appropriate public or nonpublic program, education, as indicated under COMAR 01.04.04.18B; and</text> </paragraph> <paragraph num="C."> <text>From a mental health professional:</text> <paragraph num="(1)"> <text>Regular individual mental health treatment, according to the ITP developed by the mental health professional; and</text> </paragraph> <paragraph num="(2)"> <text>As required by the child's ITP, needed evaluation and consultation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Evaluative Services Provided by the TGH."> <paragraph num="A."> <text>Therapeutic Milieu. The clinical coordinator, as defined in Regulation .14C of this chapter, shall assure maintenance of the therapeutic milieu in order to foster achievement of a child's treatment goals.</text> </paragraph> <paragraph num="B."> <text>Diagnosis. Within 1 week of a child's admission to the TGH, the clinical coordinator shall ensure that a staff member authorized under the Health Occupations Article, Annotated Code of Maryland, and credentialed and privileged by the program to formulate a psychiatric diagnosis, shall:</text> <paragraph num="(1)"> <text>Formulate and document in the child's medical record a diagnosis based on a face-to-face assessment of the child, that includes:</text> <paragraph num="(a)"> <text>A description of the presenting problem;</text> </paragraph> <paragraph num="(b)"> <text>Relevant history;</text> </paragraph> <paragraph num="(c)"> <text>Mental status examination; and</text> </paragraph> <paragraph num="(d)"> <text>The rationale for the diagnosis; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Affirm the psychiatric diagnosis documented as part of the application for admission under Regulation .09B(3) of this chapter that has been entered in the child's medical record.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Assessment. Using the evaluation materials submitted as part of the application for admission, before or within 1 week of the child's admission to the TGH, the TGH clinical coordinator shall assure the completion of an assessment that includes, as indicated, an assessment of the child's:</text> <paragraph num="(1)"> <text>Developmental history;</text> </paragraph> <paragraph num="(2)"> <text>Educational history;</text> </paragraph> <paragraph num="(3)"> <text>Family history and evaluation of current family status, including legal custody status;</text> </paragraph> <paragraph num="(4)"> <text>Home environment;</text> </paragraph> <paragraph num="(5)"> <text>Social, emotional, and cognitive development;</text> </paragraph> <paragraph num="(6)"> <text>Motor, language, and self-care skills development;</text> </paragraph> <paragraph num="(7)"> <text>History, if any, of:</text> <paragraph num="(a)"> <text>Substance abuse;</text> </paragraph> <paragraph num="(b)"> <text>Physical or sexual abuse; and</text> </paragraph> <paragraph num="(c)"> <text>Home or community violence;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Local department of social services or Department of Juvenile Services involvement, if any;</text> </paragraph> <paragraph num="(9)"> <text>Mental status; and</text> </paragraph> <paragraph num="(10)"> <text>Medical history and needs, including, if any, history of allergies, neurologic disorders, and communicable diseases.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Initial Brief Treatment Plan. Not later than 1 week following admission, the TGH clinical coordinator shall prepare an initial brief treatment plan:</text> <paragraph num="(1)"> <text>Based on the:</text> <paragraph num="(a)"> <text>Application materials submitted as required under Regulation .09B of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Assessment under §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In collaboration with:</text> <paragraph num="(a)"> <text>The child;</text> </paragraph> <paragraph num="(b)"> <text>The primary caretaker;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate TGH staff; and</text> </paragraph> <paragraph num="(d)"> <text>As appropriate and with proper consent, interested and available community treatment providers; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>That includes, at a minimum:</text> <paragraph num="(a)"> <text>The treatment goals expressed by the referring agency, if any;</text> </paragraph> <paragraph num="(b)"> <text>The process of orientation to the TGH; and</text> </paragraph> <paragraph num="(c)"> <text>Initial expectations regarding the child's adjustment to residential placement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>TGH Individual Treatment Plan (ITP).</text> <paragraph num="(1)"> <text>Treatment Team.</text> <paragraph num="(a)"> <text>At a minimum, the following individuals shall participate on a child's treatment team:</text> <paragraph num="(i)"> <text>The TGH psychiatrist;</text> </paragraph> <paragraph num="(ii)"> <text>The clinical coordinator;</text> </paragraph> <paragraph num="(iii)"> <text>The child's case coordinator; and</text> </paragraph> <paragraph num="(iv)"> <text>Other TGH staff who are involved in providing services to the child and family.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The clinical coordinator shall invite, as appropriate and with proper consent, family members and community-based providers of services to the child, including but not limited to school and mental health treatment staff, to participate as members of the child's treatment team.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Initial ITP. Within 30 days after a child is admitted to a TGH and based on the initial brief treatment plan and current observations and reports, the TGH clinical coordinator shall prepare an ITP to be addressed by TGH staff:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>The child;</text> </paragraph> <paragraph num="(ii)"> <text>The treatment team;</text> </paragraph> <paragraph num="(iii)"> <text>If present and as appropriate, the primary caretaker, family and others involved in the child's care; and</text> </paragraph> <paragraph num="(iv)"> <text>Other providers of care or treatment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That identifies the:</text> <paragraph num="(i)"> <text>Providers of mental health treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Providers of medical and dental care;</text> </paragraph> <paragraph num="(iii)"> <text>Educational program; and</text> </paragraph> <paragraph num="(iv)"> <text>TGH case coordinator;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That is coordinated with the child's:</text> <paragraph num="(i)"> <text>Individualized educational plan (IEP), when applicable;</text> </paragraph> <paragraph num="(ii)"> <text>ITP prepared by the providers of mental health treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Medical care provider;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>That documents the following information:</text> <paragraph num="(i)"> <text>Based on the physical examination required under Regulation .10A of this chapter, somatic care recommendations, including any medication prescribed, and precautions;</text> </paragraph> <paragraph num="(ii)"> <text>Nutritional requirements and limitations, if any; and</text> </paragraph> <paragraph num="(iii)"> <text>Essential medical or non-medical treatments or procedures, if any;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>That includes, at a minimum:</text> <paragraph num="(i)"> <text>The psychiatric diagnosis, as documented under §B of this regulation, in consultation with the providers of mental health treatment;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the child's current behavior, symptoms, and level of functioning that includes the child's presenting strengths, needs, and treatment expectations and responsibilities;</text> </paragraph> <paragraph num="(iii)"> <text>A description of the family's or significant others' strengths and needs, as they relate to the child;</text> </paragraph> <paragraph num="(iv)"> <text>When appropriate, identification of particular behaviors that result or may be expected to result from the child's psychiatric symptoms;</text> </paragraph> <paragraph num="(v)"> <text>Based on consultation with the providers of education and mental health treatment, short-term and long-term mental health treatment goals that are outcome-oriented and that are stated in behavioral, measurable terms;</text> </paragraph> <paragraph num="(vi)"> <text>As needed, other goals related to family, socialization and recreation, and activities of daily living; and</text> </paragraph> <paragraph num="(vii)"> <text>Identification of any medication prescribed for the treatment of a mental disorder and required monitoring of same; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>That specifies treatment strategies to be provided by TGH staff, including:</text> <paragraph num="(i)"> <text>Recommended modality and frequency of interventions;</text> </paragraph> <paragraph num="(ii)"> <text>Target dates for goal achievement;</text> </paragraph> <paragraph num="(iii)"> <text>The designation of TGH staff responsible for implementing the elements of the plan; and</text> </paragraph> <paragraph num="(iv)"> <text>When appropriate, identification of, referral to, and collaboration with other services to support the child's treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>ITP Review. As frequently as necessary, as determined by the TGH clinical coordinator, and, at a minimum of every 90 days, at a treatment team meeting with, unless clinically contraindicated, the child, the clinical coordinator shall:</text> <paragraph num="(a)"> <text>Review and record in the child's medical record:</text> <paragraph num="(i)"> <text>The child's progress toward the accomplishment of previously identified mental health treatment and other goals;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes based on a review of progress;</text> </paragraph> <paragraph num="(iii)"> <text>Changes in treatment strategies; and</text> </paragraph> <paragraph num="(iv)"> <text>Changes in diagnosis; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Communicate the results of the treatment plan review to:</text> <paragraph num="(i)"> <text>The child, if the child did not attend the ITP review team meeting;</text> </paragraph> <paragraph num="(ii)"> <text>The primary caretaker, if present;</text> </paragraph> <paragraph num="(iii)"> <text>Relevant program staff; and</text> </paragraph> <paragraph num="(iv)"> <text>The providers of mental health treatment services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Signature of the ITP and ITP Reviews.</text> <paragraph num="(a)"> <text>The child and the child's parent or guardian shall sign or tape-record agreement or disagreement with the ITP and reviews.</text> </paragraph> <paragraph num="(b)"> <text>A child's primary caretaker, if other than the parent or guardian, shall sign or tape-record acknowledgment of the ITP and reviews.</text> </paragraph> <paragraph num="(c)"> <text>In addition, the following TGH staff shall sign the ITP and reviews:</text> <paragraph num="(i)"> <text>Psychiatrist;</text> </paragraph> <paragraph num="(ii)"> <text>Clinical coordinator; and</text> </paragraph> <paragraph num="(iii)"> <text>Case coordinator.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the child’s parent, guardian, or primary caretaker does not sign the ITP or ITP reviews, staff shall document efforts to obtain the signature and reason why the signature could not be obtained.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Continuing Evaluation.</text> <paragraph num="(1)"> <text>Contact Notes. Staff involved in the contact shall document in the child's TGH medical record all significant clinically relevant face-to-face, telephone, and written contacts with or about the child, including the dates, locations, and types of contacts.</text> </paragraph> <paragraph num="(2)"> <text>Progress Summary Notes. At least every 2 weeks, a child's case coordinator shall:</text> <paragraph num="(a)"> <text>Record in the child's TGH medical record a progress summary note regarding:</text> <paragraph num="(i)"> <text>The delivery of services specified by the ITP;</text> </paragraph> <paragraph num="(ii)"> <text>Progress toward goal achievement;</text> </paragraph> <paragraph num="(iii)"> <text>Changes in the individual's status; and</text> </paragraph> <paragraph num="(iv)"> <text>If applicable, suggested changes in treatment goals and services delivered; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Assure that the child's needs and progress are communicated to those listed under §E of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Treatment and Support Services Provided by the TGH."> <paragraph num="A."> <text>Case Coordination. The TGH clinical director shall assure that a child's case coordinator:</text> <paragraph num="(1)"> <text>Integrates appropriate therapeutic and educational services into the child's ITP by coordinating with the child's previous placement provider, school, clinic or other mental health providers, and, if any, employer;</text> </paragraph> <paragraph num="(2)"> <text>Makes home visits and meets with the primary caretaker to ameliorate problems in the home and facilitate reunification; and</text> </paragraph> <paragraph num="(3)"> <text>Participates in treatment team meetings for the purposes of collaborating in service delivery and advocating for the child.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Group Therapy. Appropriately credentialed and privileged TGH staff or consultants shall, at least weekly at the TGH, provide group therapy that, unless otherwise indicated in the child's ITP, includes every child in the TGH.</text> </paragraph> <paragraph num="C."> <text>Pychoeducational Groups. As required by the child's ITP, the child's care coordinator shall assure that the child has the opportunity to participate in appropriate groups for children who have special needs, including but not limited to groups for children who have been affected by:</text> <paragraph num="(1)"> <text>Substance abuse;</text> </paragraph> <paragraph num="(2)"> <text>Sexual assault;</text> </paragraph> <paragraph num="(3)"> <text>Physical abuse; or</text> </paragraph> <paragraph num="(4)"> <text>Home or community violence.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Medication Services.</text> <paragraph num="(1)"> <text>The TGH clinical coordinator shall assure that medications prescribed for a child are stored securely and made available to the child as appropriate.</text> </paragraph> <paragraph num="(2)"> <text>Administration. If a child's ITP requires that TGH staff administer medication, the following requirements apply:</text> <paragraph num="(a)"> <text>Only an individual licensed under the Health Occupations Article, Annotated Code of Maryland, to administer medication may do so; and</text> </paragraph> <paragraph num="(b)"> <text>Only a licensed practical nurse or a registered nurse may delegate the administration of medication according to the provisions of COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitoring. When required by the child's ITP, a TGH staff member privileged to do so shall provide the following services:</text> <paragraph num="(a)"> <text>Supporting the child's self-administration of prescribed medication;</text> </paragraph> <paragraph num="(b)"> <text>To the extent possible, monitoring compliance with instructions appearing on the label;</text> </paragraph> <paragraph num="(c)"> <text>Reading the label to assure that each container of medication is clearly labeled with the child's name, the contents, directions for use, and expiration date;</text> </paragraph> <paragraph num="(d)"> <text>Observing and documenting any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority and TGH psychiatrist any problems that possibly may be related to the medication; and</text> </paragraph> <paragraph num="(e)"> <text>Reinforcing education on the role and effects of medication in symptom management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Health Promotion and Training.</text> <paragraph num="(1)"> <text>When indicated in the child's ITP, TGH staff privileged to do so shall provide basic health teaching in the following areas:</text> <paragraph num="(a)"> <text>Nutrition;</text> </paragraph> <paragraph num="(b)"> <text>Exercise;</text> </paragraph> <paragraph num="(c)"> <text>Dental care;</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse prevention; and</text> </paragraph> <paragraph num="(e)"> <text>Prevention of injury and illness at home and in the community.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The clinical coordinator shall assure the provision of training in communicable disease prevention, including prevention of sexually transmitted diseases and blood-borne pathogens, including HIV/AIDS.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Discharge Procedures. A TGH licensee shall:</text> <paragraph num="(1)"> <text>Carry out discharge planning in accordance with COMAR 14.31.06.17; and</text> </paragraph> <paragraph num="(2)"> <text>If appropriate, forward a copy of each discharge plan to the appropriate CSA and the Administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Residential Services."> <paragraph num="A."> <text>General. The chief executive officer shall assure that:</text> <paragraph num="(1)"> <text>Basic life needs are met, according to the requirements of COMAR 01.04.04.17; and</text> </paragraph> <paragraph num="(2)"> <text>Communication and visiting policies and daily routines are implemented according to the requirements of:</text> <paragraph num="(a)"> <text>Health-General Article, §§10-702 — 10-703, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.21.09; and</text> </paragraph> <paragraph num="(c)"> <text>COMAR 14.31.06.09B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision. The chief executive order shall assure that TGH staff, as defined in Regulation .14 of this chapter, provides supervision for each resident not participating in a program outside the TGH, as follows:</text> <paragraph num="(1)"> <text>During hours that children are awake and in the TGH, at least one staff member shall be present for every three children in the TGH;</text> </paragraph> <paragraph num="(2)"> <text>During children's sleeping hours, at least one awake staff member shall be present in the TGH; and</text> </paragraph> <paragraph num="(3)"> <text>At all times, at least one staff member shall be available, at the request of on-duty staff, to arrive at the TGH within 1 hour of the request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Activity. As required under COMAR 14.31.06.05H, the clinical coordinator shall assign staff to plan and implement daily activities that utilize the therapeutic milieu to foster clinically appropriate social, cognitive, emotional, and physical growth, including but not limited to:</text> <paragraph num="(1)"> <text>Group and self-directed leisure activities, both on-site and off-site, including activities related to sports and the arts;</text> </paragraph> <paragraph num="(2)"> <text>Working with the child to develop an activities schedule, including:</text> <paragraph num="(a)"> <text>Weekend and vacation plans; and</text> </paragraph> <paragraph num="(b)"> <text>Activities that support the child's cultural interests; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Developing linkages with and supporting a child's participation in community activities.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Homework. Child care staff shall supervise and assist a child with homework:</text> <paragraph num="(1)"> <text>Based on the child's needs; and</text> </paragraph> <paragraph num="(2)"> <text>By coordinating with the school.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Independent Living Skills. As required under COMAR 14.31.06.12C, in order to assist a child to develop the skills required to live independently as an adult, and as appropriate to a child's age and ability, the chief executive officer shall assign TGH staff to provide activities related to:</text> <paragraph num="(1)"> <text>Homekeeping, including:</text> <paragraph num="(a)"> <text>Meal preparation, including:</text> <paragraph num="(i)"> <text>Menu planning;</text> </paragraph> <paragraph num="(ii)"> <text>Shopping;</text> </paragraph> <paragraph num="(iii)"> <text>Cooking; and</text> </paragraph> <paragraph num="(iv)"> <text>Cleaning up;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Laundry; and</text> </paragraph> <paragraph num="(c)"> <text>Basic housekeeping;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Personal hygiene;</text> </paragraph> <paragraph num="(3)"> <text>Money-management, including basic banking knowledge;</text> </paragraph> <paragraph num="(4)"> <text>Self-preservation; and</text> </paragraph> <paragraph num="(5)"> <text>Accessing community resources, including locating and using public transportation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Work Experience. A TGH that arranges a work experience for a child shall follow the procedure in COMAR 14.31.06.12D.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Staff."> <paragraph num="A."> <text>Required Staff. The governing body of a TGH shall assure that TGH staff is sufficient in numbers and qualifications to:</text> <paragraph num="(1)"> <text>Carry out the TGH program service plan described in Regulation .05C of this chapter and program model described in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Provide the services, including supervision and staff-to-child ratio, required under Regulations .12 and .13 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Carry out the requirements of the ITPs of the TGH residents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Chief Executive Officer. The governing body shall employ a TGH chief executive officer who:</text> <paragraph num="(1)"> <text>Meets the qualifications and experience required under COMAR 14.31.06.06A;</text> </paragraph> <paragraph num="(2)"> <text>Is on duty at the TGH for the amount of time necessary to carry out the duties outlined in this chapter and, at a minimum, 20 hours per week;</text> </paragraph> <paragraph num="(3)"> <text>Is responsible for credentialing and privileging staff;</text> </paragraph> <paragraph num="(3-1)"> <text>Is responsible for administrative oversight for, at a minimum:</text> <paragraph num="(a)"> <text>Fulfilling the administrative requirements under COMAR 14.31.05;</text> </paragraph> <paragraph num="(b)"> <text>Assuring compliance with this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Maintaining sufficient staff, including recruiting, hiring, training, scheduling, and terminating;</text> </paragraph> <paragraph num="(d)"> <text>Assuring the availability, 24 hours per day, 7 days per week, of a TGH psychiatrist;</text> </paragraph> <paragraph num="(e)"> <text>In collaboration, when appropriate, with the clinical coordinator, assuring that all staff are appropriately supervised;</text> </paragraph> <paragraph num="(f)"> <text>In collaboration with the clinical coordinator and program staff, identifying staff training needs and the provision of inservice training, as required under COMAR 14.31.06.05F, and, in addition, assuring a minimum level of staff competence in at least the following:</text> <paragraph num="(i)"> <text>Understanding mental disorders and treatment modalities, including medication;</text> </paragraph> <paragraph num="(ii)"> <text>Use of seclusion, restraint, and quiet room, as governed by COMAR 10.21.12 and 10.21.13;</text> </paragraph> <paragraph num="(iii)"> <text>Verbal de-escalation and aggression management techniques and procedures;</text> </paragraph> <paragraph num="(iv)"> <text>Appropriate response to communicable diseases and use of universal precautions;</text> </paragraph> <paragraph num="(v)"> <text>Emergency preparedness and evacuation plan; and</text> </paragraph> <paragraph num="(vi)"> <text>Implementation of children's rights;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Quality management;</text> </paragraph> <paragraph num="(h)"> <text>Developing and implementing the budget;</text> </paragraph> <paragraph num="(i)"> <text>Maintaining the physical plant; and</text> </paragraph> <paragraph num="(j)"> <text>Keeping the governing body informed of, at a minimum, the program's licensure status and performance;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>May carry out the duties of the clinical coordinator, as described under §C of this regulation, if the chief executive officer is:</text> <paragraph num="(a)"> <text>A mental health professional;</text> </paragraph> <paragraph num="(b)"> <text>On duty at the TGH at least 40 hours per week, 20 hours of which must be during times when the children or adolescents are normally on-site; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If carrying out the duties of the clinical coordinator, shall hire an additional mental health professional for an additional 20 hours per week to assist with the duties described under §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical Coordinator. If the chief executive officer is not the clinical coordinator, the chief executive officer shall hire a clinical coordinator who is:</text> <paragraph num="(1)"> <text>A mental health professional;</text> </paragraph> <paragraph num="(2)"> <text>On duty at the TGH at least 20 hours per week during times when the children or adolescents are normally on-site; and</text> </paragraph> <paragraph num="(3)"> <text>Responsible for, at a minimum:</text> <paragraph num="(a)"> <text>Development of treatment procedures, including admission and discharge procedures;</text> </paragraph> <paragraph num="(b)"> <text>Development of the ITP and ITP reviews, including appropriate coordination with a child's:</text> <paragraph num="(i)"> <text>IEP;</text> </paragraph> <paragraph num="(ii)"> <text>ITP developed by the providers of mental health treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Medical care providers;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Interpreting the children's assessments and evaluations to staff;</text> </paragraph> <paragraph num="(d)"> <text>Establishing and maintaining linkage with schools and community treatment providers;</text> </paragraph> <paragraph num="(e)"> <text>Establishing protocols for medical and psychiatric emergencies and crisis response plans;</text> </paragraph> <paragraph num="(f)"> <text>Providing clinical supervision of staff; and</text> </paragraph> <paragraph num="(g)"> <text>If assigned by the TGH chief executive officer, maintenance of the therapeutic milieu described in Regulation .08C(2)(b) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>TGH Psychiatrist. The chief executive officer shall assure the availability of a psychiatrist who:</text> <paragraph num="(1)"> <text>Has completed a residency in child psychiatry in an accredited program;</text> </paragraph> <paragraph num="(2)"> <text>As specified in the employment or consultant contract, is available:</text> <paragraph num="(a)"> <text>For the amount of time necessary to carry out the duties outlined in §D(3) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>To respond to emergencies 24 hours per day, 7 days per week; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is responsible for:</text> <paragraph num="(a)"> <text>Participation in the screening, assessment, admission, and discharge processes;</text> </paragraph> <paragraph num="(b)"> <text>Formulating and documenting a diagnosis, according to Regulation .11B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Participation in the development and signing of a child's ITP and ITP reviews;</text> </paragraph> <paragraph num="(d)"> <text>Clinical supervision of those cases requiring face-to-face medical review;</text> </paragraph> <paragraph num="(e)"> <text>Consulting with staff regarding the maintenance of the therapeutic milieu;</text> </paragraph> <paragraph num="(f)"> <text>Review of medication utilization and corrective feedback when utilization is found to be inappropriate; and</text> </paragraph> <paragraph num="(g)"> <text>Medical aspects of quality management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Coordinator. The TGH chief executive officer shall employ a sufficient number of case coordinators, each of whom is:</text> <paragraph num="(1)"> <text>Either a:</text> <paragraph num="(a)"> <text>Mental health professional; or</text> </paragraph> <paragraph num="(b)"> <text>Residential care specialist who:</text> <paragraph num="(i)"> <text>Has a minimum of a high school diploma or equivalent; and</text> </paragraph> <paragraph num="(ii)"> <text>Is supervised by a mental health professional;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Available to be with the child, on site in the TGH, at least 4 days per week; and</text> </paragraph> <paragraph num="(3)"> <text>Responsible for the duties delineated under Regulation .12A of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Residential Care Specialist. The TGH chief executive officer shall employ a sufficient number of residential care specialists who:</text> <paragraph num="(1)"> <text>As determined by the chief executive officer, have sufficient qualifications and experience to carry out the duties of the position;</text> </paragraph> <paragraph num="(2)"> <text>Have training applicable to the service, including, at a minimum, training outlined in §B(3)(g) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, are available to carry out the residential services delineated under Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Program Coordinator. The TGH chief executive officer may employ a program coordinator, who shall be a mental health professional, to manage the therapeutic milieu as outlined in §C(3) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Data Submission."> <text>A TGH shall report the required data in the form and at the times specified by the Administration.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Rights."> <text>TGH staff shall explain to a child enrolled in a program and to the child's parent, guardian, and, if other than the parent, the primary caretaker, of the child's rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Grievances."> <paragraph num="A."> <text>A TGH shall develop and implement a process for the prompt and objective resolution of grievances that may be presented by a child or by a child's parent, guardian, or primary caretaker.</text> </paragraph> <paragraph num="B."> <text>The TGH shall prominently display, in accessible centralized locations, the written description of the grievance procedure.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-501 — 10-524, 10-701 — 10-714, 10-901, 10-920 — 10-926, 16-101 — 16-303; Article 49D, §4; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 13, 1986 (13:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .14 repealed and new Regulations .01 — .17 adopted effective November 27, 2000 (27:23 Md. R. 2147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12F amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B, C amended effective April 29, 2013 (40:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14G adopted effective April 29, 2013 (40:8 Md. R. 723)</annotation> </annotations> </chapter> <chapter num="08" heading="Services for Mentally Ill Hearing Impaired Patients in Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The following regulations govern the provision of services for hearing impaired mentally ill patients within the Administration's facilities and the designated inpatient hearing impaired unit.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Maryland Department of Health Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Audiologist” means an individual who is authorized to practice audiology under Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Certified interpreter for hearing impaired persons” means an interpreter who possesses at the minimum a Comprehensive Skills Certificate issued by the Registry of Interpreters for the Deaf.</text> </paragraph> <paragraph num="(4)"> <text>“Documented history of deafness or hearing impairment” means a documented diagnosis of hearing impairment made by an audiologist or by a Board-eligible or Board-certified otolaryngologist.</text> </paragraph> <paragraph num="(5)"> <text>“Facility” means an inpatient or residential treatment program operated directly by the Administration.</text> </paragraph> <paragraph num="(6)"> <text>“Gross testing” means either an interactive process which screens a person's ability to follow ordinary conversation or pure tone audiometric screening.</text> </paragraph> <paragraph num="(7)"> <text>“Hearing aid” means any instrument or device designed for or represented as aiding, improving, or correcting hearing and any parts, attachments, or accessories of this instrument or device.</text> </paragraph> <paragraph num="(8)"> <text>“Hearing impaired individual” means a person with an impairment so severe that with or without amplification, the processing of linguistic information through hearing is impaired.</text> </paragraph> <paragraph num="(9)"> <text>“Individual treatment plan” means the plan of care identified for each patient as outlined in COMAR 10.21.03.</text> </paragraph> <paragraph num="(10)"> <text>“Mental illness” means an illness resulting from a psychiatric disorder and does not include a primary diagnosis of alcohol or drug abuse or developmental disability.</text> </paragraph> <paragraph num="(11)"> <text>“Otolaryngologist” means a physician identified by the State Board of Physician Quality Assurance as a specialist in otolaryngology as set forth in Health Occupations Article, §14-704, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Pure tone audiometric screening” means the pure tone air conduction screening procedure used to rapidly and effectively identify a patient with a hearing impairment that interferes with or has the potential for interfering with communication.</text> </paragraph> <paragraph num="(14)"> <text>“Qualified allied health professional” means the staff assigned by the facility and trained by an audiologist in procedures outlined in this chapter.</text> </paragraph> <paragraph num="(15)"> <text>“Rinne and Weber testing” means the tuning fork test used to differentiate between conductive and sensory-neural hearing losses.</text> </paragraph> <paragraph num="(16)"> <text>“Speech-language pathologist” means an individual who is authorized to practice speech-language pathology under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Speech reading” means the use of visual cues in determining what the speaker is saying and may also be referred to as lip reading.</text> </paragraph> <paragraph num="(18)"> <text>“Unit” means the inpatient unit of the institution designated by the Administration created specifically to treat those patients having both a mental illness and a hearing impairment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Identification of Hearing Impaired Patients."> <paragraph num="A."> <text>Patients admitted to facilities shall be screened for hearing impairment.</text> </paragraph> <paragraph num="B."> <text>Gross Testing of Hearing Sensitivity.</text> <paragraph num="(1)"> <text>At each facility, an examination shall be performed for gross testing of hearing sensitivity on all newly admitted patients within 24 hours of admission. This examination shall be performed:</text> <paragraph num="(a)"> <text>By a physician or a qualified allied health professional; and</text> </paragraph> <paragraph num="(b)"> <text>According to the following protocol:</text> <paragraph num="(i)"> <text>Testing shall occur consistently at a fixed distance from the speaker at all times;</text> </paragraph> <paragraph num="(ii)"> <text>In order to prevent speech reading which could be interpreted as a false positive, the speaker's face may not be in view by the patient while testing is in process; and</text> </paragraph> <paragraph num="(iii)"> <text>Non-English speaking patients shall be tested in the language the patient is known to speak or is believed to comprehend.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Testing performed in conformance with §B(1) of this regulation shall be repeated within 15 days after admission on all patients not already tested with a pure tone screening audiometer.</text> </paragraph> <paragraph num="(3)"> <text>Each test performed in compliance with this regulation shall be documented in the patient's chart.</text> </paragraph> <paragraph num="(4)"> <text>Once a hearing impairment is suspected:</text> <paragraph num="(a)"> <text>Rinne and Weber testing shall be performed; and</text> </paragraph> <paragraph num="(b)"> <text>Referral shall be made for audiometric screening.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Audiometric Screening.</text> <paragraph num="(1)"> <text>Patients with Suspected Hearing Impairment.</text> <paragraph num="(a)"> <text>Pure tone audiometric screening shall occur within 3 working days from the period specified in §B(1), of this regulation, for any patient who:</text> <paragraph num="(i)"> <text>Is suspected of having a hearing impairment on the basis of any of the above tests;</text> </paragraph> <paragraph num="(ii)"> <text>Was unresponsive because of a possible hearing impairment; or</text> </paragraph> <paragraph num="(iii)"> <text>Responded in a manner that may be construed as a mental disorder, but may be confused with a possible hearing impairment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Patients suspected of having a hearing impairment on the basis of the latest pure tone audiometric screening shall be referred promptly but in not more than 5 working days to an audiologist or an otolaryngologist. Referral shall be documented in the patient's chart.</text> </paragraph> <paragraph num="(c)"> <text>Upon recommendation by either the otolaryngologist or audiologist, further evaluation by a speech-language pathologist shall be conducted.</text> </paragraph> <paragraph num="(d)"> <text>If the audiometric screening in this section is used as the initial screening test, that audiometric screening shall be sufficient testing on admission unless otherwise ordered.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patients Not Identified as Hearing Impaired. As soon as possible, but within 90 days after admission, each patient who has not already been screened with an audiometer shall be so evaluated.</text> </paragraph> <paragraph num="(3)"> <text>Each patient's annual physical examination shall include audiometric screening. The screening results shall be documented in the patient's chart.</text> </paragraph> <paragraph num="(4)"> <text>Procedures for Audiometric Screening.</text> <paragraph num="(a)"> <text>The audiometric screening shall be performed in accordance with the standards outlined in Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>The audiometric screening shall be administered by either:</text> <paragraph num="(i)"> <text>A physician trained to screen hearing according to the protocol established in this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>An audiologist; or</text> </paragraph> <paragraph num="(iii)"> <text>Appropriately and periodically trained allied health care staff, under the supervision and monitoring of an audiologist.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An audiologist shall determine the facility's training protocol and frequency of training for allied health care staff. At a minimum, training shall occur at least once a year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Patients Exempted from Audiometric Screening. If the patient has a history of hearing impairment as defined in Regulation .02B(8) of this chapter and documented by an audiologist or physician, the screening procedure identified in §B and C of this regulation is not required within the first year after admission.</text> </paragraph> <paragraph num="E."> <text>Treatment recommendations related to the patient's hearing impairment made by either an audiologist, otolaryngologist, or speech pathologist, shall be incorporated in the patient's Individual Treatment Plan.</text> </paragraph> <paragraph num="F."> <text>Provision and Maintenance of Hearing Aids.</text> <paragraph num="(1)"> <text>The patient and appropriate staff on each shift shall receive, in accordance with a plan developed by an audiologist, instructions on the care, use, and inspection of the hearing aid by staff referenced in §C(4)(b)(i) and (ii) of this regulation or the hearing aid vendor.</text> </paragraph> <paragraph num="(2)"> <text>Designated staff, as identified in the Individual Treatment Plan, shall be responsible for ensuring daily monitoring of hearing aids, and implementing timely repair and immediate replacement of batteries.</text> </paragraph> <paragraph num="(3)"> <text>Identification of the need for replacement as well as the replacement of the patient's hearing aid shall be documented in the patient's record.</text> </paragraph> <paragraph num="(4)"> <text>Denial of hearing aid replacement by the treatment team or the patient's refusal to accept a hearing aid shall be documented and be reevaluated at a minimum of every 3 months.</text> </paragraph> <paragraph num="(5)"> <text>The facility shall provide a hearing aid to the patient when an otolaryngologist or audiologist determines that a patient would benefit from amplification and related accessories. Payments for aids shall follow the Administration's policy on payment for medical devices.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards for Identification Audiometry."> <paragraph num="A."> <text>Staff, as defined in Regulation .03C(4)(b), of this chapter, shall conduct manually administered, individual pure tone air conduction screening procedures for identification audiometry on each patient with a developmental age of 3 years or older. The following apply:</text> <paragraph num="(1)"> <text>Patients with a developmental age of less than 3 years shall be referred to an audiologist for an evaluation.</text> </paragraph> <paragraph num="(2)"> <text>Group screening may not be conducted on any patient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pure tone testing shall use test frequencies at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Screening levels shall be 20dB hearing level at all frequencies tested.</text> </paragraph> <paragraph num="C."> <text>Audiometers Used for Screening Purposes.</text> <paragraph num="(1)"> <text>For either a limited range or a narrow range audiometer, audiometers shall meet the requirements found in “Specifications for Audiometers” (ANSI S3.6-1969, American National Standards Institute), which is incorporated by reference.</text> </paragraph> <paragraph num="(2)"> <text>Audiometers shall be calibrated by an appropriately and professionally trained person at least annually.</text> </paragraph> <paragraph num="(3)"> <text>Sound pressure at the ear phones shall be checked at least every 3 months.</text> </paragraph> <paragraph num="(4)"> <text>Daily listening checks shall be performed to determine that the audiometer is grossly in calibration and that no defects exist in major components.</text> </paragraph> <paragraph num="(5)"> <text>An audiologist shall instruct support personnel in the proper handling and operation of audiometric equipment in order to minimize the need for repairs and to improve test accuracy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In accordance with Regulation .05 and the requirements found in “Criteria for Permissible Ambient Noise During Audiometric Testing” (ANSI S3.1-1977 American National Standards Institute), which is incorporated by reference, ambient noise levels may not exceed 41.5 dB Sound Pressure Level (SPL) at 500 Hz, 49.5 dB SPL at 1000 Hz, 54.5 dB SPL at 2000 Hz, and 62 dB SPL at 4000 Hz when measured using a sound level meter with octave-band filters centered on the screening frequencies.</text> </paragraph> <paragraph num="E."> <text>Nonresponse to the recommended screening levels at any frequency in either ear shall constitute failure.</text> </paragraph> <paragraph num="F."> <text>Failures shall be rescreened within the same screening session, if possible.</text> </paragraph> <paragraph num="G."> <text>Failures on rescreening shall be referred for an audiologic evaluation by an audiologist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for the Acoustical Environment."> <text>The test tones listed in this regulation shall meet the allowable octave-band ambient noise levels which are noted in the following table taken from page 5 of the May 1985 ASHA journal:</text> <text>Test frequency 500 1000 2000 4000 Octave-band cutoff 300 600 1200 2400 Frequencies 600 1200 2400 4800 Octave-band level: Ear covered with earphone mounted in MX-41/AR cushion 21.5 29.5 34.5 42 Plus ASHA screening level 20 20 20 20 Resultant maximum ambient noise level allowable for ASHA screening 41.5 49.5 54.5 62</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Springfield Hospital Unit for Hearing Impaired Patients."> <paragraph num="A."> <text>Transfer Criteria. To be transferred to the unit, each patient shall:</text> <paragraph num="(1)"> <text>Meet the statutory criteria for admission as set forth in Health-General Article, §10-609 — 10-619, Annotated Code of Maryland, and other applicable regulations related to the involuntary and voluntary admissions to facilities.</text> </paragraph> <paragraph num="(2)"> <text>Have documentation of deafness or a hearing impairment.</text> </paragraph> <paragraph num="(3)"> <text>Currently be using visual, manual, or tactile modes of communication which include but are not limited to American sign language, finger spelling, or speech reading, or be capable of being trained in the use of those methods.</text> </paragraph> <paragraph num="(4)"> <text>Be 14 years old or older. Patients 14 to 18 years old shall reside in:</text> <paragraph num="(a)"> <text>A separate inpatient residence designated for minors and attend the day program of the hearing-impaired unit if the:</text> <paragraph num="(i)"> <text>Treatment teams of the unit and of the minor's inpatient residence approve;</text> </paragraph> <paragraph num="(ii)"> <text>Approval is documented in the progress notes and the Individual Treatment Plan; and</text> </paragraph> <paragraph num="(iii)"> <text>Individual Treatment Plan is not in conflict with the Individual Educational Plan;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The unit if the:</text> <paragraph num="(i)"> <text>Unit treatment team approves; and</text> </paragraph> <paragraph num="(ii)"> <text>Individual plan for treatment indicates the need for placement on the unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Be capable, with auxiliary aids, if necessary, of participating in professionally developed and supervised therapies, experiences, and activities provided by the unit.</text> </paragraph> <paragraph num="(6)"> <text>Have documentation in that patient's record that the patient does not object to participation on the unit, based on information necessary to make an informed judgment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Referral Procedures to the Unit After a Patient is Admitted to a Facility.</text> <paragraph num="(1)"> <text>Referral procedures for facilities shall be established by the Administration.</text> </paragraph> <paragraph num="(2)"> <text>Unit staff, in consultation with the treating physician, shall:</text> <paragraph num="(a)"> <text>Follow the Administration's referral procedures; and</text> </paragraph> <paragraph num="(b)"> <text>Within 7 days of a determination of hearing impairment by history or pure tone audiometric screening, determine the appropriateness of transfer of that patient to the unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Unit Personnel and Training.</text> <paragraph num="(1)"> <text>The unit shall be directed by and include a complement of professional staff who have training or experience, or both, in working with hearing impaired mentally ill persons.</text> </paragraph> <paragraph num="(2)"> <text>Unit staff shall develop and maintain skills relevant to the provision of services for hearing impaired persons which include, but are not limited to, training in the psychosocial needs of hearing impaired persons and instruction in American sign language. A credentialing process to review the continuing education program for unit staff shall be determined by the Administration.</text> </paragraph> <paragraph num="(3)"> <text>Certified interpreters for hearing impaired patients, or other staff who possess equivalent qualifications as determined by a certified interpreter designated by the facility for that purpose, shall be on duty on the unit 24 hours a day.</text> </paragraph> <paragraph num="(4)"> <text>Facility staff may not be scheduled to provide interpreter services and any other services at the same time.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Determination of Placement."> <paragraph num="A."> <text>Each hearing impaired patient in a facility, regardless of other handicapping conditions, shall be referred for evaluation for transfer to the unit pursuant to this regulation and Regulations .06 and .08A of this chapter. The following apply:</text> <paragraph num="(1)"> <text>The referring facility's treating physician shall refer any:</text> <paragraph num="(a)"> <text>Previously diagnosed hearing impaired patient to the unit within 72 hours of admission; or</text> </paragraph> <paragraph num="(b)"> <text>Patient newly identified as hearing impaired pursuant to this chapter, within 72 hours of identification.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The unit staff, in consultation with the patient's treating physician at the referring facility, shall assess the appropriateness of the transfer, including but not limited to the criteria listed in Regulation .06A of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The assessment and decision regarding transfer of the patient shall be documented and sent to the referring facility by the unit's assessment team within 7 working days of referral.</text> </paragraph> <paragraph num="(4)"> <text>The decision regarding transfer and its rationale shall:</text> <paragraph num="(a)"> <text>Become a part of the permanent record; and</text> </paragraph> <paragraph num="(b)"> <text>Include the names and titles of the assessment team members.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, after referral and assessment, the patient's transfer to the unit is denied, the decision and its rationale shall be documented in the patient's chart by the unit's director or unit director's designee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the decision is made to transfer the patient to the unit, the transfer shall occur not later than 2 working days after the determination to do so, unless a bed is not available on the unit.</text> </paragraph> <paragraph num="C."> <text>The unit shall establish and maintain a waiting list for patients who have been accepted into the unit and are awaiting transfer.</text> </paragraph> <paragraph num="D."> <text>The date of entry onto the waiting list shall determine placement on the waiting list, except that priority shall be given to transfer patients from areas of known shortage of resources for mentally ill hearing impaired persons.</text> </paragraph> <paragraph num="E."> <text>Decisions related to priority transfers shall be made by the unit director or the unit director's designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Services for Hearing Impaired Patients Not in the Unit."> <paragraph num="A."> <text>Unless the age of a minor hearing impaired patient precludes transfer to the unit, the referring facility's treating physician shall refer the patient for evaluation to the unit at least every 60 days in order to:</text> <paragraph num="(1)"> <text>Reevaluate the appropriateness for the transfer to the unit; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain consultation for any appropriate treatment options.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall provide auxiliary aids in accordance with the provisions of §504 of the Rehabilitation Act of 1973, 29 U.S.C. §794 and its implementing regulations, 45 CFR §84.52(d), which are incorporated by reference, for the hearing impaired patient to participate in the facility's professionally developed and supervised activities, therapies, and experiences. Auxiliary aids may include but are not limited to interpreter services, notetakers, special hearing assistive devices, and telecommunication devices for the deaf (TTD).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Procedure Pertaining to Complaints."> <text>Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 8, 1990 (16:26 Md. R. 2792)</annotation> </annotations> </chapter> <chapter num="09" heading="Patients' Rights to Visitors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the rights of patients in all facilities as defined in Health-General Article, §§10-101(e) and 10-703, Annotated Code of Maryland. Pursuant to Health-General Article, §10-703, Annotated Code of Maryland, and for the safety and well-being of patients, their visitors and staff members, all of these facilities shall provide public notice to patients, family members, and friends of the hours allowed for visiting on facility grounds and the conditions under which visiting is permitted.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Attorney” means a person licensed to practice law or the attorney's agent.</text> </paragraph> <paragraph num="(3)"> <text>“Clergy” means an official of a recognized church, religious society, or congregation of any sect, order, or denomination.</text> </paragraph> <paragraph num="(4)"> <text>“Disorderly manner” means conduct as defined by Criminal Law Article, §10-202, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Drugs” means any medically unauthorized substance as defined by Criminal Law Article, §5-101(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute care general hospital that does not have a separately identified inpatient psychiatric service.</text> </paragraph> <paragraph num="(7)"> <text>“Patient” means any individual receiving care and treatment in a facility.</text> </paragraph> <paragraph num="(8)"> <text>“Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Professional staff” means any clinical staff who is either licensed or certified in a health care field or clinical staff in charge of a residential area.</text> </paragraph> <paragraph num="(10)"> <text>“Visitor” means a person who is coming to see a patient and is not acting as an agent of the facility or the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Facility Visitation and Visiting Hours."> <paragraph num="A."> <text>All facilities shall provide a conspicuously posted notice to patients, family members, and friends of the hours allowed for visiting on facility grounds and the conditions under which visiting is permitted.</text> </paragraph> <paragraph num="B."> <text>Visitation procedures and visiting hours shall be reasonable and each facility shall allow for visiting hours for at least 1 hour per day for each day of the week.</text> </paragraph> <paragraph num="C."> <text>Each facility administrator shall be responsible for ensuring that these regulations are available for review and shall post notice of the facility's visiting hours in a prominent location.</text> </paragraph> <paragraph num="D."> <text>Visiting hours do not apply to the patient's clergy or attorney who may visit the patient at any reasonable hour.</text> </paragraph> <paragraph num="E."> <text>Visiting hours do not apply during those times a person visits the patient at the request of the treatment team.</text> </paragraph> <paragraph num="F."> <text>Patients who wish to visit with children under the age of 12 may request a suitable location from the staff for the visit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Visitation Areas."> <paragraph num="A."> <text>Specific areas shall be designated as visitor areas and may be subject to supervision by facility staff.</text> </paragraph> <paragraph num="B."> <text>Patients shall have the right to converse in private subject to the restrictions of Health-General Article, §10-703(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Visitors may not be allowed on the patient units without staff permission or supervision, or both.</text> </paragraph> <paragraph num="D."> <text>Visiting may not be allowed in seclusion rooms.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedures Pertaining to Visitors."> <paragraph num="A."> <text>Staff may not provide child care services for visitors.</text> </paragraph> <paragraph num="B."> <text>Visitors who leave children unattended and without adequate supervision shall be asked to correct the situation or shall be expected to terminate the visit immediately.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Visitor Behavior."> <paragraph num="A."> <text>Specific visitor behaviors that are prohibited include, but are not limited to:</text> <paragraph num="(1)"> <text>Verbal or physical abuse or both of staff or patients;</text> </paragraph> <paragraph num="(2)"> <text>Drinking of alcoholic beverages;</text> </paragraph> <paragraph num="(3)"> <text>Use of drugs;</text> </paragraph> <paragraph num="(4)"> <text>Distribution of alcoholic beverages or drugs;</text> </paragraph> <paragraph num="(5)"> <text>Intoxication when on the premises;</text> </paragraph> <paragraph num="(6)"> <text>Disregard for patient or staff safety;</text> </paragraph> <paragraph num="(7)"> <text>Assaultive behavior; or</text> </paragraph> <paragraph num="(8)"> <text>Acting in a disorderly manner.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The staff may ask visitors to remove from the facility any items or to submit the items to search. Specific notice to this effect shall be posted conspicuously at all times.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Removal of Visitors."> <paragraph num="A."> <text>Professional staff shall request any visitor who jeopardizes the care or treatment of patients or the safety of patients, staff, or other visitors to leave the facility immediately and explain at the time of the request the reason or reasons for making the request.</text> </paragraph> <paragraph num="B."> <text>Whenever a visitor refuses to leave, the visitor shall be informed that the facility police or law enforcement agencies shall be called immediately to escort the visitor off facility premises.</text> </paragraph> <paragraph num="C."> <text>If the visitor continues to resist, formal arrest procedures may be initiated.</text> </paragraph> <paragraph num="D."> <text>Specific notice to this effect shall be posted conspicuously at all times.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Documentation."> <paragraph num="A."> <text>Incidents.</text> <paragraph num="(1)"> <text>Any visitor behavior that leads to removal of the visitor from the premises shall be documented.</text> </paragraph> <paragraph num="(2)"> <text>Any incident that requires police intervention shall be reported and documented in accordance with facility procedures.</text> </paragraph> <paragraph num="(3)"> <text>Whenever a visitor is removed from the facility as a result of their disorderly manner, the treatment team shall review the incident and determine what restrictions, if any, shall be placed on the individual's future visiting privileges.</text> </paragraph> <paragraph num="(4)"> <text>If restrictions are placed on an individual's future visiting privileges, the restrictions shall be subject to the requirements identified in Regulation .08B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Patient Restriction.</text> <paragraph num="(1)"> <text>Visitation shall be restricted only for a medically justified reason, and may not be used as a means of punishment.</text> </paragraph> <paragraph num="(2)"> <text>The physician's order restricting patient visitation rights shall:</text> <paragraph num="(a)"> <text>Be written as an order in the patient's permanent record;</text> </paragraph> <paragraph num="(b)"> <text>Be subject to ongoing review;</text> </paragraph> <paragraph num="(c)"> <text>Automatically expire after 30 calendar days; and</text> </paragraph> <paragraph num="(d)"> <text>Be rewritten, if necessary, subject to the provisions of this subsection.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The rationale for the restriction shall be noted in the patient's permanent record and signed by the physician.</text> </paragraph> <paragraph num="(4)"> <text>Restrictions shall be documented in the patient's individualized treatment plan as defined in COMAR 10.21.03.</text> </paragraph> <paragraph num="(5)"> <text>A member of the treatment team shall inform the patient in a timely fashion of the restriction, its rationale, and the length of time the restriction is in effect.</text> </paragraph> <paragraph num="(6)"> <text>With the consent of the patient, visitors shall be informed by the facility's Clinical Director, or the Clinical Director's designee, that a patient's visits are restricted and the length of time that the restriction is in effect.</text> </paragraph> <paragraph num="(7)"> <text>Upon request and with the consent of the patient, a visitor shall receive written notification of the restriction or restrictions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Patient's Refusal to Receive Visitors."> <paragraph num="A."> <text>Whenever a patient refuses visitors, the refusal shall be noted in the patient's records and may be reviewed by the treatment team.</text> </paragraph> <paragraph num="B."> <text>The patient's refusal shall be honored.</text> </paragraph> <paragraph num="C."> <text>With the consent of the patient, visitors shall be informed in a timely manner of the patient's refusal.</text> </paragraph> <paragraph num="D."> <text>When a patient refuses to receive a visitor and refuses to permit the facility to inform the visitor of the patient's refusal, the facility's communications with the visitor shall be consistent with these wishes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Procedures Pertaining to Complaints."> <text>Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-101(e) and 10-703, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 8, 1990 (16:26 Md. R. 2793)</annotation> </annotations> </chapter> <chapter num="10" heading="Psychiatric Residential Treatment Facility (PRTF) Demonstration Waiver Providers"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the requirements for a provider of psychiatric residential treatment facilities (PRTF) Medicaid demonstration waiver services as set forth in COMAR 10.09.79. These services are:</text> <paragraph num="A."> <text>Caregiver peer-to-peer support;</text> </paragraph> <paragraph num="B."> <text>Crisis and stabilization services;</text> </paragraph> <paragraph num="C."> <text>Expressive and experiential behavioral services;</text> </paragraph> <paragraph num="D."> <text>Family and youth training;</text> </paragraph> <paragraph num="E."> <text>Respite services (in-home and out-of-home); and</text> </paragraph> <paragraph num="F."> <text>Youth peer-to-peer support.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.09.79.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <paragraph num="A."> <text>The Department shall grant approval to providers to be eligible to receive State and federal funds for PRTF waiver services if the provider meets the requirements set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>Application. To provide PRTF waiver services, a provider applicant shall:</text> <paragraph num="(1)"> <text>Submit an application to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Submit the application on the form approved by the Department, with all questions answered and all required documents attached; and</text> </paragraph> <paragraph num="(3)"> <text>Attest that the provider applicant is in compliance with the general provider requirements and specific PRTF waiver service requirements set forth in this chapter and in COMAR 10.09.36.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application Modification.</text> <paragraph num="(1)"> <text>A provider that proposes to change its PRTF waiver services sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department.</text> </paragraph> <paragraph num="(2)"> <text>If the Department approves the application modification, the existing provider approval shall extend to the additional site, as applicable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Approval.</text> <paragraph num="(1)"> <text>The Department may grant approval to an applicant provider, for a period not to exceed 12 months, if the Department determines that the provider:</text> <paragraph num="(a)"> <text>On the effective date of this chapter, has an existing contract with an existing care management entity under contract with a local management board in a service area;</text> </paragraph> <paragraph num="(b)"> <text>Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and</text> </paragraph> <paragraph num="(c)"> <text>Attests that it complies with the requirements set forth in this chapter, and with the specific service requirements set forth in COMAR 10.09.79.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the provider is granted approval under §D(1) of this regulation, to continue to be approved, the provider shall, within 12 months, submit documentation of compliance with the requirements set forth in this chapter, and with the specific service requirements set forth in COMAR 10.09.79.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall grant approval to a provider if the Department determines that the provider applicant meets the requirements set forth in this chapter and the specific service requirements set forth in COMAR 10.09.79.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Recertification. The provider is subject to recertification by the Department every 3 years.</text> </paragraph> <paragraph num="F."> <text>Sale or Transfer of Approval.</text> <paragraph num="(1)"> <text>The Department's approval of a PRTF waiver service provider is valid only for the provider to which the Department grants approval.</text> </paragraph> <paragraph num="(2)"> <text>A provider may not sell, assign, or transfer approval to another provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Denial, Emergency Suspension of Approval, and Disciplinary Action."> <paragraph num="A."> <text>Denial of Approval.</text> <paragraph num="(1)"> <text>If the Department proposes to deny approval to an applicant under the provisions of this chapter, the Department shall give written notice of the proposed denial to the:</text> <paragraph num="(a)"> <text>Provider applicant;</text> </paragraph> <paragraph num="(b)"> <text>Care management entity; and</text> </paragraph> <paragraph num="(c)"> <text>Administrative service organization (ASO).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the notice under §A(1) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The date on which the Department proposes to deny approval;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed denial of approval;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed denial is based;</text> </paragraph> <paragraph num="(d)"> <text>Notification that before the denial of approval, the provider may request a hearing under the provisions of COMAR 10.21.16; and</text> </paragraph> <paragraph num="(e)"> <text>When feasible, notification of a case resolution conference.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Disciplinary Action.</text> <paragraph num="(1)"> <text>The Department may propose to take any of the following disciplinary actions against a provider:</text> <paragraph num="(a)"> <text>Revocation of approval;</text> </paragraph> <paragraph num="(b)"> <text>Suspension of approval;</text> </paragraph> <paragraph num="(c)"> <text>Probation with conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Banning new admissions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may propose to take one of the actions outlined in §B(1) of this regulation if the provider:</text> <paragraph num="(a)"> <text>Is out of compliance with the requirements of:</text> <paragraph num="(i)"> <text>This chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.09.79;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Fails to maintain financial viability; or</text> </paragraph> <paragraph num="(c)"> <text>Obtains or attempts to obtain approval by fraud, misrepresentation, or the submission of false information to the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except under §C of this regulation, the Department shall send written notice of the proposed action not less than 45 calendar days in advance of the proposed action taken under this regulation to the:</text> <paragraph num="(a)"> <text>Provider;</text> </paragraph> <paragraph num="(b)"> <text>Care management entity; and</text> </paragraph> <paragraph num="(c)"> <text>ASO.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the notice under §B(3) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The date on which the Department proposes to take action and, when feasible, the date of a case resolution conference;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed action;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed action is based; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that, before the action, the provider has the right to request a hearing under the provisions of COMAR 10.21.16.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, after notice and opportunity to be heard, the Department takes disciplinary action, the provider shall, within 10 working days:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the action; and</text> </paragraph> <paragraph num="(b)"> <text>If the program ceases operations:</text> <paragraph num="(i)"> <text>Notify individuals or the guardians of individuals receiving services of the suspension; and</text> </paragraph> <paragraph num="(ii)"> <text>Cooperate with the care management entity, child and family team, and the Mental Hygiene Administration in accessing appropriate alternate services for individuals served by the provider.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency Suspension of Approval.</text> <paragraph num="(1)"> <text>Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a provider, the Department may order the immediate suspension of the approval of the provider and the cessation of operation.</text> </paragraph> <paragraph num="(2)"> <text>If the Department takes the action under §C(1) of this regulation, the Department shall promptly give written notice of the proposed emergency suspension to the:</text> <paragraph num="(a)"> <text>Provider;</text> </paragraph> <paragraph num="(b)"> <text>Care management entity; and</text> </paragraph> <paragraph num="(c)"> <text>ASO.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the notice under §C(2) of this regulation, the Department shall include:</text> <paragraph num="(a)"> <text>The proposed effective date of the emergency suspension;</text> </paragraph> <paragraph num="(b)"> <text>When feasible, the date of a pre-deprivation hearing and a case resolution conference before the Department's final action;</text> </paragraph> <paragraph num="(c)"> <text>The findings under §C(1) of this regulation and the reasons that support the findings;</text> </paragraph> <paragraph num="(d)"> <text>Notification that:</text> <paragraph num="(i)"> <text>Following the emergency suspension, the provider may request a hearing under the provisions of COMAR 10.21.16; and</text> </paragraph> <paragraph num="(ii)"> <text>The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Department suspends approval, the provider shall immediately:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the suspension;</text> </paragraph> <paragraph num="(b)"> <text>Cooperate with the care management entity, child and family team, and the Mental Hygiene Administration in accessing appropriate alternate services for individuals in the program; and</text> </paragraph> <paragraph num="(c)"> <text>Cease operations of the program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="General Conditions for PRTF Waiver Services Provider Participation."> <paragraph num="A."> <text>A provider of PRTF waiver services shall:</text> <paragraph num="(1)"> <text>Provide the documentation required by the Department for initial approval and provider recertification, or as requested by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Be approved by the Department as meeting the requirements of this chapter and COMAR 10.09.79, and being able to provide the services set forth in COMAR 10.09.79;</text> </paragraph> <paragraph num="(3)"> <text>Have a provider agreement in effect, to include adherence to quality assurance, auditing, and monitoring policies and procedures;</text> </paragraph> <paragraph num="(4)"> <text>Receive training and certification as required and approved by MHA and determined to be appropriate for the level and scope of services provided;</text> </paragraph> <paragraph num="(5)"> <text>Meet all the conditions for participation in COMAR 10.09.36 except as otherwise specified in this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Maintain general liability insurance, and provide proof of this insurance at the time of initial application to be a provider of PRTF waiver services, at recertification, and upon request by the Department;</text> </paragraph> <paragraph num="(7)"> <text>Make available to the Department and federal funding agents all records, including but not limited to personnel files for each individual employed, and financial, treatment, and service records for inspection and copying; and</text> </paragraph> <paragraph num="(8)"> <text>Comply with the following prohibitions against utilization of staff:</text> <paragraph num="(a)"> <text>Unless waived by the Department in accordance with §D of this regulation, prohibit from working with the participant or the participant's family any staff, volunteers, students, or any individual who is:</text> <paragraph num="(i)"> <text>Convicted of, received probation before judgment, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft; or</text> </paragraph> <paragraph num="(ii)"> <text>Has an indicated finding of child abuse or neglect;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Before permitting staff, volunteers, students, or any individual from working with the participant, or the participant's family:</text> <paragraph num="(i)"> <text>Ensure that, at its own expense, all staff, volunteers, students, and any individual have background checks as set forth in §§B and C of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Review the results of the background checks; and</text> </paragraph> <paragraph num="(iii)"> <text>Maintain the background checks in the individual's personnel file; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain written documentation in the individual's personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Required Criminal Background Checks. For each individual providing services to participants and their families in the PRTF waiver, the provider shall:</text> <paragraph num="(1)"> <text>Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Request that DPSCS send the report to:</text> <paragraph num="(a)"> <text>The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or</text> </paragraph> <paragraph num="(b)"> <text>To the Department's designee, if the provider is a self-employed, independent practitioner, or the director of the agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Required Check for Abuse or Neglect. For each individual providing services to participants and their families in the PRTF waiver, the provider shall:</text> <paragraph num="(1)"> <text>Before employing any individual, submit a notarized Consent for Release of Information/Background Clearance Request form to the Department of Human Services (DHS) or a local department of social services (DSS) in the jurisdiction in which the individual lives, pursuant to COMAR 07.02.07.19; and</text> </paragraph> <paragraph num="(2)"> <text>Request that DHS or the local DSS send the report to:</text> <paragraph num="(a)"> <text>The director of the agency if the request is from a provider agency concerning staff, volunteers, or students who will work with the participant or family; or</text> </paragraph> <paragraph num="(b)"> <text>To the Department's designee, if the provider is a self-employed, independent practitioner, or the director of the agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant's family if the provider submits a request to the Department together with the following documentation that:</text> <paragraph num="(1)"> <text>For criminal background checks:</text> <paragraph num="(a)"> <text>The conviction, the probation before judgment, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application;</text> </paragraph> <paragraph num="(b)"> <text>The criminal history does not indicate behavior that is potentially harmful to participants; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For abuse and neglect findings:</text> <paragraph num="(a)"> <text>The indicated finding occurred more than 7 years before the date of the clearance request;</text> </paragraph> <paragraph num="(b)"> <text>The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant's family; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a statement from the individual as to the reasons the prohibition should be waived.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Specific Conditions for PRTF Waiver Services Providers — Respite Services."> <text>To be eligible to provide PRTF waiver services as a provider of in-home or out-of-home respite services under COMAR 10.09.79.06B, a provider shall:</text> <paragraph num="A."> <text>Meet the requirements of COMAR 10.21.27;</text> </paragraph> <paragraph num="B."> <text>Ensure that respite care specialists are:</text> <paragraph num="(1)"> <text>21 years old or older and have a high school diploma; or</text> </paragraph> <paragraph num="(2)"> <text>Between 18 and 20 years old and in possession of at least an associate or bachelor's degree from an accredited school in a human services field;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Ensure that:</text> <paragraph num="(1)"> <text>In-home respite services are provided in the participant's home; and</text> </paragraph> <paragraph num="(2)"> <text>Out-of-home respite services are:</text> <paragraph num="(a)"> <text>Provided in a community based alternative living arrangement outside the participant's home; and</text> </paragraph> <paragraph num="(b)"> <text>Where applicable, delivered in accordance with COMAR 14.31.05 — 14.31.07.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Specific Conditions for PRTF Waiver Service Providers — Caregiver Peer-to-Peer Support and Youth Peer-to-Peer Support."> <paragraph num="A."> <text>A family support organization may provide PRTF waiver services of caregiver peer-to-peer support, youth peer-to-peer support, or family and youth training. To be eligible to provide PRTF waiver services as a family support organization, the organization shall:</text> <paragraph num="(1)"> <text>Be a private, nonprofit entity designated under §501(c)(3) of the Internal Revenue Service Code, and submit copies of the certificate of incorporation and Internal Revenue Service designation;</text> </paragraph> <paragraph num="(2)"> <text>Have a board of directors comprised of more than 50 percent caregivers with a primary daily responsibility for raising a child or youth up to 26 years old with emotional, behavioral, or mental health challenges;</text> </paragraph> <paragraph num="(3)"> <text>Submit a list of board members with identification of those who are caregivers meeting the criteria in §A(2) of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Establish hiring practices that give preference to:</text> <paragraph num="(a)"> <text>Current or previous caregivers of a child or youth with emotional, behavioral, or mental health challenges;</text> </paragraph> <paragraph num="(b)"> <text>Youth who are 18 through 26 years old, who have or had emotional or behavioral health challenges, or both; or</text> </paragraph> <paragraph num="(c)"> <text>Both §A(4)(a) and (b) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Submit a copy of the organization's personnel policy that sets forth the preferred employment criteria stated in §A(4) of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Employ a staff that is comprised of at least 75 percent individuals who are:</text> <paragraph num="(a)"> <text>Current or previous caregivers of a child or youth with emotional, behavioral, or mental health challenges; or</text> </paragraph> <paragraph num="(b)"> <text>Youth who are 18 through 26 years old with emotional, behavioral, or mental health challenges;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Submit a list of staff and positions held with identification of those who fit the experienced caregiver and youth criteria stated in §A(6) of this regulation; and</text> </paragraph> <paragraph num="(8)"> <text>Submit a certificate of eligibility that includes:</text> <paragraph num="(a)"> <text>Attestation of compliance with §A(1) — (6) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The organization's mission statement that establishes the purpose of the organization as providing support and education to youth with emotional, behavioral, or mental health challenges and their caregivers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Caregiver Peer-to-Peer Support Provider. To provide the services set forth COMAR 10.09.79.06B, the provider shall:</text> <paragraph num="(1)"> <text>Be employed by a family support organization;</text> </paragraph> <paragraph num="(2)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Receive supervision from an individual who is 21 years old or older, and has at least 3 years of experience providing peer-to-peer support;</text> </paragraph> <paragraph num="(4)"> <text>Have current or prior experience as a caregiver of a child with SED or a young adult with SMI; and</text> </paragraph> <paragraph num="(5)"> <text>Receive training and certification as approved by MHA.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Youth Peer-to-Peer Support Provider. To provide services set forth in COMAR 10.09.79.06B, a provider shall:</text> <paragraph num="(1)"> <text>Be 18 years old or older but not older than 26 years old;</text> </paragraph> <paragraph num="(2)"> <text>Be employed by a family support organization;</text> </paragraph> <paragraph num="(3)"> <text>Have experience with State or local services and systems as a consumer who has had emotional, behavioral, or mental health challenges;</text> </paragraph> <paragraph num="(4)"> <text>Be supervised by an individual who is 21 years old or older, and has at least 3 years of experience providing peer-to-peer support or working with youth, or both; and</text> </paragraph> <paragraph num="(5)"> <text>Receive training and certification as approved by MHA.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specific Conditions for PRTF Waiver Service Providers — Family and Youth Training."> <paragraph num="A."> <text>Family and Youth Training Providers. To provide services set forth COMAR 10.09.79.06B, a provider shall be:</text> <paragraph num="(1)"> <text>An approved waiver provider agency, including but not limited to, a family support organization; or</text> </paragraph> <paragraph num="(2)"> <text>An approved individual waiver service provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualifications to Provide Family and Youth Training Services.</text> <paragraph num="(1)"> <text>All family and youth training providers shall:</text> <paragraph num="(a)"> <text>Receive training and certification as approved by MHA; and</text> </paragraph> <paragraph num="(b)"> <text>Have been a co-trainer with an experienced lead trainer.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Youth training providers shall:</text> <paragraph num="(a)"> <text>Be 18 years old or older but not older than 26 years old; and</text> </paragraph> <paragraph num="(b)"> <text>Have experience with State or local services and systems as a consumer who has or had emotional, behavioral or mental health challenges.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Family training providers shall:</text> <paragraph num="(a)"> <text>Be 21 years old or older; and</text> </paragraph> <paragraph num="(b)"> <text>Have current or prior experience as a caregiver of a child with SED or a young adult with SMI.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Specific Conditions for PRTF Waiver Service Providers — Expressive and Experiential Behavioral Services."> <paragraph num="A."> <text>Expressive and experiential behavioral services are:</text> <paragraph num="(1)"> <text>Art behavioral services;</text> </paragraph> <paragraph num="(2)"> <text>Dance/movement behavioral services;</text> </paragraph> <paragraph num="(3)"> <text>Equine-assisted behavioral services;</text> </paragraph> <paragraph num="(4)"> <text>Horticultural behavioral services;</text> </paragraph> <paragraph num="(5)"> <text>Music behavioral services; and</text> </paragraph> <paragraph num="(6)"> <text>Psychodrama/drama behavioral services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualification to Provide Expressive and Experiential Behavioral Services.</text> <paragraph num="(1)"> <text>To provide a particular service set forth under COMAR 10.09.79.06B, an individual shall have:</text> <paragraph num="(a)"> <text>A bachelor's or master's degree from an accredited college or university; and</text> </paragraph> <paragraph num="(b)"> <text>Current registration in the applicable association as outlined in §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Association Registration.</text> <paragraph num="(a)"> <text>Art Behavioral Services. To provide art behavioral services, an individual shall be currently registered as a registered art therapist by:</text> <paragraph num="(i)"> <text>The Art Therapy Credentials Board in the American Art Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For Dance Behavioral Services. To provide dance behavioral services, an individual shall be currently registered as a dance therapist registered, or an academy of dance therapists registered in:</text> <paragraph num="(i)"> <text>The American Dance Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For Equine-Assisted Behavioral Services. To provide equine-assisted behavioral services, an individual shall be currently certified by:</text> <paragraph num="(i)"> <text>The Equine Assisted Growth and Learning Association (EAGALA) to provide services under the EAGALA model;</text> </paragraph> <paragraph num="(ii)"> <text>The North American Handicapped Riding Association (NAHRA); or</text> </paragraph> <paragraph num="(iii)"> <text>A comparable association with certification requirements at least equivalent to EAGALA or NAHRA.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For Horticultural Behavioral Services. To provide horticultural behavioral services, an individual shall be currently registered as a horticultural therapist registered in:</text> <paragraph num="(i)"> <text>The American Horticultural Therapy Association; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For Music Behavioral Services. To provide music behavioral services, an individual shall be currently registered as a music therapist-board certified by the Board for Music Therapists, Inc:</text> <paragraph num="(i)"> <text>In the American Association for Music Therapy, Inc.; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>For Psychodrama/Drama Behavioral Services. To provide psychodrama/drama behavioral services, an individual shall be currently registered as a registered drama therapist or a board certified trainer in:</text> <paragraph num="(i)"> <text>The National Association for Drama Therapy; or</text> </paragraph> <paragraph num="(ii)"> <text>A comparable association with equivalent requirements.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Specific Conditions for PRTF Waiver Service Providers — Crisis and Stabilization Services."> <text>To provide the services set forth COMAR 10.09.79.06B, a provider shall:</text> <paragraph num="A."> <text>Be an agency;</text> </paragraph> <paragraph num="B."> <text>Have a current formal written agreement with a local core service agency to serve as a crisis response system;</text> </paragraph> <paragraph num="C."> <text>Have capacity to provide or arrange for services 24 hours a day, 7 days per week, including:</text> <paragraph num="(1)"> <text>Face-to-face clinical care;</text> </paragraph> <paragraph num="(2)"> <text>Psychiatric consultation; and</text> </paragraph> <paragraph num="(3)"> <text>Person-to-person phone coverage;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Employ clinical supervisors who:</text> <paragraph num="(1)"> <text>Are licensed in good standing under Health Occupations Article, Annotated Code of Maryland, as a psychiatrist, social worker, registered nurse, or mental health professional;</text> </paragraph> <paragraph num="(2)"> <text>Are permitted to provide supervision under their respective practice act; and</text> </paragraph> <paragraph num="(3)"> <text>Have experience providing crisis response services; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>Employ behavior care aides who:</text> <paragraph num="(1)"> <text>Are 21 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Have a bachelor's degree in a human services field; and</text> </paragraph> <paragraph num="(3)"> <text>Receive initial and ongoing training on crisis and stabilization services.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 15-130.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 20, 2009 (36:8 Md. R. 595)</annotation> </annotations> </chapter> <chapter num="11" heading="Purchase of Residential Therapeutic Care for Children"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the requirements that a provider of residential therapeutic services to emotionally or behaviorally disordered children shall meet to be eligible to accept children placed by the Mental Hygiene Administration.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Direct supervision” means that a provider staff member maintains continuous visual contact with the child.</text> </paragraph> <paragraph num="(2)"> <text>“Family of origin” means the child's parent, guardian, or primary caretaker.</text> </paragraph> <paragraph num="(3)"> <text>“Least restrictive setting” means the treatment program or facility in which needed services are delivered in the environment that least limits the child being served.</text> </paragraph> <paragraph num="(4)"> <text>“Oversight” means that a provider staff member approves and is aware of the child's activities.</text> </paragraph> <paragraph num="(5)"> <text>“Primary caretaker” means the adult individual who carries responsibility for the welfare of a child where the child resides.</text> </paragraph> <paragraph num="(6)"> <text>“Secure setting” means a treatment program or facility that is locked to prevent a child from leaving without staff permission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Provider Requirements."> <text>A provider of residential therapeutic services may not be eligible to accept children placed by the Maryland Department of Health unless the provider:</text> <paragraph num="A."> <text>Is licensed by the Department of:</text> <paragraph num="(1)"> <text>Human Services, under the provisions of COMAR 07.02.23 or 07.02.13;</text> </paragraph> <paragraph num="(2)"> <text>Juvenile Services, under the provisions of COMAR 16.06.01; or</text> </paragraph> <paragraph num="(3)"> <text>Maryland Department of Health , under the provisions of COMAR 10.21.07;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Has rates that are established by the Negotiated Rates Process of the Rates Management Unit, Social Services Administration of the Department of Human Services as authorized under the provisions of COMAR 21.14.01.04B(2);</text> </paragraph> <paragraph num="C."> <text>Provides the following core services:</text> <paragraph num="(1)"> <text>Care and 24-hour supervision in a residential setting;</text> </paragraph> <paragraph num="(2)"> <text>Direct provision of food and clothing;</text> </paragraph> <paragraph num="(3)"> <text>Social work or case management services;</text> </paragraph> <paragraph num="(4)"> <text>Recreational activities;</text> </paragraph> <paragraph num="(5)"> <text>Access and linkage to appropriate community resources, including but not limited to:</text> <paragraph num="(a)"> <text>Medical care;</text> </paragraph> <paragraph num="(b)"> <text>Dental care;</text> </paragraph> <paragraph num="(c)"> <text>Mental health treatment;</text> </paragraph> <paragraph num="(d)"> <text>Education; and</text> </paragraph> <paragraph num="(e)"> <text>Social services; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Crisis intervention planning;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Provides the additional services that, based on a documented clinical assessment, are required by the child who is being referred, including but not limited to:</text> <paragraph num="(1)"> <text>A location as close as possible to the child's family of origin;</text> </paragraph> <paragraph num="(2)"> <text>The least restrictive setting appropriate to the child's needs; and</text> </paragraph> <paragraph num="(3)"> <text>As appropriate to the child's needs, a level of supervision that provides:</text> <paragraph num="(a)"> <text>Opportunity for off-site activities, with oversight by provider staff; or</text> </paragraph> <paragraph num="(b)"> <text>For a placement that is authorized by the State Coordinating Council for Residential Placement of Handicapped Children or a local coordinating council, as authorized under Article 49D, §§13 — 19, Annotated Code of Maryland:</text> <paragraph num="(i)"> <text>Structured, on-site activities, with direct supervision by provider staff, and 24-hour awake staff; or</text> </paragraph> <paragraph num="(ii)"> <text>The level of supervision described in §D(3)(b)(i) of this regulation in a secure setting; and</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Is in compliance with all applicable laws and regulations, including but not limited to laws and regulations governing patient rights, as set forth in Health-General Article, §§10-701 — 10-707, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 adopted as an emergency provision effective October 13, 1992 (19:22 Md. R. 1980); adopted permanently effective March 29, 1993 (20:1 Md. R. 27)</annotation> </annotations> </chapter> <chapter num="12" heading="Use of Quiet Room and Use of Restraint"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the use of quiet rooms and restraint in all facilities as defined in Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland. These regulations are supplemental to any other applicable law and regulation. In the event of conflict between these regulations and any other regulations or laws, the more stringent apply.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Category I Restraint.</text> <paragraph num="(a)"> <text>“Category I restraint” means a device identified by the facility which limits a patient's mobility to the extent that the patient would not be able to independently reposition himself or herself or would otherwise be rendered helpless in an emergency.</text> </paragraph> <paragraph num="(b)"> <text>“Category I restraint” includes, but is not limited to, four-point restraints.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Category II restraint” means any device which is not considered by the facility as a category I restraint and includes, but is not limited to, mittens and vests.</text> </paragraph> <paragraph num="(3)"> <text>“Chief executive officer (CEO)” means the individual responsible for the overall management of a facility.</text> </paragraph> <paragraph num="(4)"> <text>“Child” means an individual younger than 12 years old.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical director” means the psychiatrist in charge of the clinical care of all psychiatric patients in the facility.</text> </paragraph> <paragraph num="(6)"> <text>“Emergency situation” means a situation in which a patient's behavior poses a serious and imminent danger to the physical safety of self or others.</text> </paragraph> <paragraph num="(7)"> <text>“Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute general hospital that does not have a separately identified inpatient psychiatric service.</text> </paragraph> <paragraph num="(8)"> <text>“Full view” means the unobstructed view by the assigned staff of a restrained patient.</text> </paragraph> <paragraph num="(9)"> <text>“Patient” means an individual receiving services for a mental disorder in a facility and includes any student receiving care and treatment in that facility.</text> </paragraph> <paragraph num="(10)"> <text>“Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Protective device” means any adaptive or assistive device or devices which restrict the movement of the whole or a portion of a patient's body for the purpose of preventing unintentional harm to self or others or which are used for promoting or maintaining normative body functions.</text> </paragraph> <paragraph num="(12)"> <text>Prone Restraint.</text> <paragraph num="(a)"> <text>“Prone restraint” means restricting the free movement of all or a portion of a patient’s body through the use of physical force or mechanical devices while the patient is in a prone position.</text> </paragraph> <paragraph num="(b)"> <text>“Prone restraint” does not mean a technique for transitioning a patient to a restraint position that involves momentarily placing the individual face down.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Quiet room” means an unlocked room that patients are not physically prevented from leaving, which is designated for patients' voluntary use to allow them time out of the company of other patients.</text> </paragraph> <paragraph num="(14)"> <text>“Registered nurse” means an individual who is licensed to practice registered nursing under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>Restraint.</text> <paragraph num="(a)"> <text>“Restraint” means:</text> <paragraph num="(i)"> <text>Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move their arms, legs, body, or head freely; or</text> </paragraph> <paragraph num="(ii)"> <text>A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Restraint” does not include a helmet when used as a sole form of restraint or a protective device.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Seclusion” means the involuntary confinement of a patient under the direction of a physician or registered nurse alone in a room which a patient is physically prevented from leaving.</text> </paragraph> <paragraph num="(17)"> <text>“Trauma-informed care” means mental health treatment that includes:</text> <paragraph num="(a)"> <text>An appreciation for the high prevalence of trauma experienced by individuals receiving mental health services;</text> </paragraph> <paragraph num="(b)"> <text>An understanding of the neurological, biological, psychological, and social effects of trauma and violence, including sexual abuse and exploitation, on an individual; and</text> </paragraph> <paragraph num="(c)"> <text>An understanding of the environment, practices, and treatments that may need to be modified to address trauma issues.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Treatment team” means the patient's treatment team as defined in COMAR 10.21.03.02C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of Restraint."> <paragraph num="A."> <text>Staff authorized under the provisions of Regulation .05B of this chapter may use a restraint:</text> <paragraph num="(1)"> <text>Only during an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury;</text> </paragraph> <paragraph num="(2)"> <text>If ordered by a physician in writing; or</text> </paragraph> <paragraph num="(3)"> <text>If at the direction of a registered nurse, if a physician's order is obtained within 2 hours of the action.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff may not use a restraint:</text> <paragraph num="(1)"> <text>As a mode or course of treatment;</text> </paragraph> <paragraph num="(2)"> <text>As punishment, coercion, discipline, or retaliation;</text> </paragraph> <paragraph num="(3)"> <text>For the convenience of staff;</text> </paragraph> <paragraph num="(4)"> <text>To prevent damage or destruction to property; or</text> </paragraph> <paragraph num="(5)"> <text>To prevent serious disruption of the therapeutic environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall use a restraint:</text> <paragraph num="(1)"> <text>In a humane, safe, and effective manner;</text> </paragraph> <paragraph num="(2)"> <text>Without intent to harm or create undue discomfort to the patient; and and</text> </paragraph> <paragraph num="(3)"> <text>For the shortest possible length of time, regardless of the length of time in the physician's order.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staff authorized under the provisions of Regulation .05B of this chapter may order the use of a restraint only if the physician, following a clinical evaluation of the patient, determines that:</text> <paragraph num="(1)"> <text>The patient's behavior poses an emergency situation; and</text> </paragraph> <paragraph num="(2)"> <text>Less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The approaches referred to in §D(2) of this regulation may include, but are not limited to:</text> <paragraph num="(1)"> <text>Clinical interventions;</text> </paragraph> <paragraph num="(2)"> <text>Quiet room;</text> </paragraph> <paragraph num="(3)"> <text>Medication or medications;</text> </paragraph> <paragraph num="(4)"> <text>Deescalation techniques;</text> </paragraph> <paragraph num="(5)"> <text>Trauma-informed care interventions;</text> </paragraph> <paragraph num="(6)"> <text>Calling the hospital's response team for assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Consulting the patient's care plan for personalized strategies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Protective Device Use."> <paragraph num="A."> <text>When the definition of a restraint or a protective device is in dispute, in each case under discussion, the clinical director or the clinical director's physician designee shall clarify and document in the patient's medical record the device's correct purpose.</text> </paragraph> <paragraph num="B."> <text>The patient's treatment team shall document in the treatment plan the team's rationale for use of a protective device.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedures in the Use of Restraint."> <paragraph num="A."> <text>A facility shall:</text> <paragraph num="(1)"> <text>Have a written policy specifying the method used to ensure that a patient whose primary language or method of communication is nonverbal is able to effectively communicate distress during a physical restraint or hold; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that all staff at the facility who are authorized to participate in a physical restraint or hold of a patient are trained in the method specified in the written policy in accordance with §A(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician who is responsible either for the care of the patient or for assessment of the appropriateness of a restraint or, when the appropriate physician is not readily available to assess the patient, a registered nurse shall conduct a clinical evaluation of the patient to determine whether an emergency situation is present.</text> </paragraph> <paragraph num="C."> <text>Before using restraint, the physician or registered nurse shall assess whether less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others.</text> </paragraph> <paragraph num="D."> <text>When a physician, as identified in §B of this regulation, is immediately available, the physician shall be responsible for determining a patient's need for a restraint and make the decision whether to restrain.</text> </paragraph> <paragraph num="E."> <text>Authorization in the Absence of a Physician.</text> <paragraph num="(1)"> <text>When a physician, as identified in §B of this regulation, is not immediately available, a registered nurse shall determine a patient's need for restraint and may initiate and direct the use of restraint.</text> </paragraph> <paragraph num="(2)"> <text>Within 2 hours of the implementation of the restraint, a physician shall give a written or verbal order for any restraint initiated by a registered nurse and, at that time, shall make the clinical determination to continue or to discontinue the restraint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Placement of Patient in Restraint."> <paragraph num="A."> <text>When possible, staff shall advise a patient, in a nonthreatening manner, that continuation of a specific behavior may result in the use of restraint.</text> </paragraph> <paragraph num="B."> <text>When a physician or registered nurse determines that the use of a restraint is appropriate, staff involved shall make a reasonable effort to verbally persuade the patient to be cooperative with the restraint.</text> </paragraph> <paragraph num="C."> <text>Staff shall apply a restraint only in accordance with the facility's policy and procedure manual.</text> </paragraph> <paragraph num="D."> <text>For the patient's safety and the safety of others:</text> <paragraph num="(1)"> <text>Staff shall place the patient in the restraint in as dignified a manner as the situation permits, using the least amount of physical force necessary;</text> </paragraph> <paragraph num="(2)"> <text>As necessary, additional staff shall participate in the placement of a patient in restraint;</text> </paragraph> <paragraph num="(3)"> <text>The patient shall be free from subject prone restraint; and</text> </paragraph> <paragraph num="(4)"> <text>The patient shall be free from a restraint that:</text> <paragraph num="(a)"> <text>Applies pressure to the patient’s back;</text> </paragraph> <paragraph num="(b)"> <text>Obstructs the airway of the patient or impairs the patient’s ability to breathe;</text> </paragraph> <paragraph num="(c)"> <text>Obstructs a staff member’s view of the patient’s face; or</text> </paragraph> <paragraph num="(d)"> <text>Restricts the patent’s ability to communicate distress.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Unless a physician or registered nurse determines that it is unsafe to do so, staff shall permit the patient to wear all or a portion of the patient's own clothes or another form of attire.</text> </paragraph> <paragraph num="F."> <text>Staff shall search the patient for potentially harmful objects.</text> </paragraph> <paragraph num="G."> <text>If staff determine a need for objects to be removed pursuant to §F of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects.</text> </paragraph> <paragraph num="H."> <text>Unless contraindicated for safety reasons, staff shall permit the patient to wear eyeglasses, hearing aids, dentures, or prosthetic devices.</text> </paragraph> <paragraph num="I."> <text>When placing a patient in a restraint, staff shall inspect each restraining device and ensure that each restraining device is safely and securely applied.</text> </paragraph> <paragraph num="J."> <text>As necessary, staff shall ensure that each restraint is padded to provide appropriate protection for the patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations and Placement of Children in Restraint."> <text>In addition to the requirements outlined in this chapter, when:</text> <paragraph num="A."> <text>Restraining a child, staff may not use four-point restraints; and</text> </paragraph> <paragraph num="B."> <text>Applying or repositioning a restraint, staff shall avoid the application of force on long bone joints.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Clinical Interventions During Restraint."> <paragraph num="A."> <text>Regardless of the physical setting in which the patient is placed, at a minimum, one staff member shall be assigned continuously while the patient is in a category I restraint.</text> </paragraph> <paragraph num="B."> <text>While the patient is restrained, in order to provide appropriate clinical care, at a minimum, staff clinically trained to do so shall:</text> <paragraph num="(1)"> <text>Keep the patient in full view at all times;</text> </paragraph> <paragraph num="(2)"> <text>Protect the patient from harm by others;</text> </paragraph> <paragraph num="(3)"> <text>Closely observe the patient at least every 15 minutes, and document each observation by the observer;</text> </paragraph> <paragraph num="(4)"> <text>Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, at least hourly, make and document personal contact with the patient for the purpose of:</text> <paragraph num="(a)"> <text>Determining if the patient has any special needs which need attention;</text> </paragraph> <paragraph num="(b)"> <text>Checking circulation of the extremities restrained;</text> </paragraph> <paragraph num="(c)"> <text>Adjusting the restraint; and</text> </paragraph> <paragraph num="(d)"> <text>Realigning the body or massaging the extremities restrained, or both;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, offer or provide the following:</text> <paragraph num="(a)"> <text>Full range of motion, every 2 hours;</text> </paragraph> <paragraph num="(b)"> <text>Toilet facilities, at least every 2 hours;</text> </paragraph> <paragraph num="(c)"> <text>Bathing and oral hygiene, at least once during a 24-hour period;</text> </paragraph> <paragraph num="(d)"> <text>Meals, at the regularly scheduled hours and under the supervision of nursing personnel; and</text> </paragraph> <paragraph num="(e)"> <text>Fluids, at least every 2 hours; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>As clinically indicated, record temperature, pulse, blood pressure, and respirations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least once every 2 hours, a physician or registered nurse shall assess the appropriateness of continuing the restraint and document the factors supporting the assessment in the patient's medical record.</text> </paragraph> <paragraph num="D."> <text>When the patient's behavior no longer places the patient or others in serious threat of violence or injury, the patient shall be released from restraint.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Limitations on Restraint and Continuous Restraint."> <paragraph num="A."> <text>Staff may not initiate “standing” or “as needed” orders for restraint.</text> </paragraph> <paragraph num="B."> <text>Each order for restraint, used for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, may only be renewed in accordance with the following limits not to exceed 24 hours total:</text> <paragraph num="(1)"> <text>Four hours for adults 18 years of age or older;</text> </paragraph> <paragraph num="(2)"> <text>Two hours for children and adolescents 9 to 17 years of age; or</text> </paragraph> <paragraph num="(3)"> <text>One hour for children under 9 years of age.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After 24 hours, before writing a new order for the use of restraint for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, a physician must:</text> <paragraph num="(1)"> <text>See, assess, and conduct a face-to-face evaluation of the patient to determine whether continuous restraint is appropriate;</text> </paragraph> <paragraph num="(2)"> <text>Document in the patient's medical record the observed behavior that confirms that the patient, if released from restraint, would continue to present a danger to self or others;</text> </paragraph> <paragraph num="(3)"> <text>Follow all requirements outlined in this chapter, including but not limited to §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Obtain the authorization of the clinical director or the clinical director's physician designee, neither of whom may be the treating physician.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon a request from a patient's treating physician, prior to authorizing continued restraint in accordance with §C(4) of this regulation, the clinical director or the clinical director's designee shall perform a face-to-face evaluation of the patient who is restrained.</text> </paragraph> <paragraph num="E."> <text>Following the initial 24 hours of restraint authorized under §C of this regulation, additional periods of restraint, not to exceed 24 hours each, may be authorized only if the restraint is provided in accordance with §§B—D of this regulation.</text> </paragraph> <paragraph num="F."> <text>Treatment Team Involvement.</text> <paragraph num="(1)"> <text>Minimally, at regularly scheduled meetings, the patient's treatment team shall examine the use of restraint for that patient.</text> </paragraph> <paragraph num="(2)"> <text>Within 5 working days from the initiation of continuous restraint, regardless of whether the patient remains in restraint, the treatment team shall:</text> <paragraph num="(a)"> <text>When applicable, review the appropriateness of the continued use of restraint;</text> </paragraph> <paragraph num="(b)"> <text>Establish and implement a plan to eliminate the need for further restraint; and</text> </paragraph> <paragraph num="(c)"> <text>Identify a team member who shall explain to the patient the potential risks and benefits of continuous restraint.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Documentation."> <paragraph num="A."> <text>Restraint Orders. A physician shall:</text> <paragraph num="(1)"> <text>To initiate the use of restraint:</text> <paragraph num="(a)"> <text>Enter an order in the patient's medical record; or</text> </paragraph> <paragraph num="(b)"> <text>Authorize an order to be written by a registered nurse on the physician's order sheet in the patient's medical record:</text> <paragraph num="(i)"> <text>Indicating that physician's verbal order for restraint; or</text> </paragraph> <paragraph num="(ii)"> <text>Directing the release of the patient and the rationale for that release;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Countersign all verbal orders within 24 hours of the order's being written; and</text> </paragraph> <paragraph num="(3)"> <text>Include in the order for restraint:</text> <paragraph num="(a)"> <text>The date and time that the order was written;</text> </paragraph> <paragraph num="(b)"> <text>The specific type of restraint to be used;</text> </paragraph> <paragraph num="(c)"> <text>The maximum duration of restraint from the time that the restraint was initiated;</text> </paragraph> <paragraph num="(d)"> <text>The specific rationale for restraint;</text> </paragraph> <paragraph num="(e)"> <text>Special precautions, if any, to safeguard the patient;</text> </paragraph> <paragraph num="(f)"> <text>The physician's signature; and</text> </paragraph> <paragraph num="(g)"> <text>In the case of a verbal order, the names of both the ordering physician and the registered nurse who received the verbal order.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>As soon as possible after implementation, but not later than the close of the shift, staff shall:</text> <paragraph num="(1)"> <text>Document the implementation of restraint in the patient's medical record; and</text> </paragraph> <paragraph num="(2)"> <text>Include in the documentation the following information:</text> <paragraph num="(a)"> <text>A description of the specific behavior leading to restraint;</text> </paragraph> <paragraph num="(b)"> <text>Whether and which less restrictive techniques were used, and, if not, why not;</text> </paragraph> <paragraph num="(c)"> <text>Whether a formal call for facility staff response was required, the names of staff assisting in the restraint, and the circumstances while restraining the patient;</text> </paragraph> <paragraph num="(d)"> <text>The readily observable physical condition of the patient;</text> </paragraph> <paragraph num="(e)"> <text>The date and time of the restraint and signature of the recorder;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was permitted to wear the patient's own clothes or other attire and, if not, the reason or reasons for this; and</text> </paragraph> <paragraph num="(g)"> <text>A description of any physical injury to either the patient or others resulting from placement of the patient in restraint.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>While a patient is restrained, staff shall document the clinical interventions employed, including those listed in Regulation .08 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Release from Restraint.</text> <paragraph num="(1)"> <text>When a physician clinically determines that a patient is to be released from restraint, the physician shall:</text> <paragraph num="(a)"> <text>Order the release and write, sign, and date a note indicating the rationale for the release; and</text> </paragraph> <paragraph num="(b)"> <text>If verbally ordering the release, write, sign, and date the note not later than 24 hours after a verbal order to release.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a registered nurse clinically determines that the release of the patient before the maximum period specified on a physician's order is appropriate, the registered nurse shall:</text> <paragraph num="(a)"> <text>Direct termination of the restraint; and</text> </paragraph> <paragraph num="(b)"> <text>Document, sign, and date the rationale for the termination of restraint in the patient's medical record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Use of Quiet Room."> <paragraph num="A."> <text>Patient Request.</text> <paragraph num="(1)"> <text>A patient may request the use of a quiet room and, unless clinically contraindicated, may be granted use of a quiet room.</text> </paragraph> <paragraph num="(2)"> <text>Unless staff terminates use of the quiet room for clinical reasons, the patient may terminate self-initiated use of the quiet room at any time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Request.</text> <paragraph num="(1)"> <text>When staff, permitted by the facility to initiate and terminate use of a quiet room, determine that the use of the quiet room is clinically indicated, staff may request that a patient voluntarily enter into the quiet room.</text> </paragraph> <paragraph num="(2)"> <text>Staff may not coerce a patient into entering the quiet room.</text> </paragraph> <paragraph num="(3)"> <text>When the patient enters the quiet room, staff shall discuss with the patient:</text> <paragraph num="(a)"> <text>The recommended length of stay in the quiet room;</text> </paragraph> <paragraph num="(b)"> <text>The behaviors expected of the patient before and upon return to the milieu; and</text> </paragraph> <paragraph num="(c)"> <text>The primary interventions to be initiated if the use of the quiet room is terminated by the patient before the time recommended by staff or is determined to be ineffective.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall determine the need for removal of any harmful objects in the room or from the patient.</text> </paragraph> <paragraph num="D."> <text>If staff determine a need for objects to be removed pursuant to §C of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects.</text> </paragraph> <paragraph num="E."> <text>While a quiet room is in use, the staff shall assure that the quiet room door is not locked or in a position that prevents a patient from exiting the room voluntarily.</text> </paragraph> <paragraph num="F."> <text>Observation and Documentation. Staff shall:</text> <paragraph num="(1)"> <text>Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room;</text> </paragraph> <paragraph num="(2)"> <text>When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and</text> </paragraph> <paragraph num="(3)"> <text>At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A physician shall review the use of the quiet room after 6 hours and, if use of the quiet room is continued, at least every 24 hours after that.</text> </paragraph> <paragraph num="H."> <text>Use of a quiet room may be terminated at any time:</text> <paragraph num="(1)"> <text>Upon the decision of the patient; or</text> </paragraph> <paragraph num="(2)"> <text>As clinically determined by staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Quality Assurance."> <paragraph num="A."> <text>The clinical director or the clinical director's designee shall review daily all uses of restraint and investigate unusual or possibly unwarranted patterns of use.</text> </paragraph> <paragraph num="B."> <text>The physician involved in the restraint may not function in the capacity outlined in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>A facility shall identify a committee to review periodically, but not less than quarterly, the use of restraint to assure that the standards maintained by the facility are, at a minimum, consistent with this chapter.</text> </paragraph> <paragraph num="D."> <text>Staff who implement orders for restraint:</text> <paragraph num="(1)"> <text>Shall have documented annual training in the proper use of physical restraint and hold including training for special populations which include, but are not limited to, children and the elderly;</text> </paragraph> <paragraph num="(2)"> <text>Shall have documented annual training in trauma-informed care and demonstrate competency in providing trauma-informed care services; and</text> </paragraph> <paragraph num="(3)"> <text>May not implement orders for restraint until trained by the facility to do so unless, in an emergency situation, the safety of the patient or others is threatened.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The facility's chief executive officer or the chief executive officer's designee is responsible for assuring that the restraint devices used in that facility are maintained in accordance with acceptable standards for hygiene and safety.</text> </paragraph> <paragraph num="F."> <text>If seclusion is used in conjunction with restraint, staff shall also comply with COMAR 10.21.13.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Procedures Pertaining to Complaints."> <text>Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Variance with Standards."> <paragraph num="A."> <text>Excluding the prohibition described in §B of this regulation, staff may not vary from the standards identified in this chapter unless the variation is for an extreme crisis.</text> </paragraph> <paragraph num="B."> <text>There may not be any variance with standards established in this regulation and in Regulations .03 and .04, .06B—G and I—J, .07, .09A, .11, .12A and D—F, .13, and .14 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Staff shall document, on the facility's variance report, a variance with standards permitted under this chapter.</text> </paragraph> <paragraph num="D."> <text>The CEO shall rule on and document each variance permitted in §A of this regulation to determine whether the variance was:</text> <paragraph num="(1)"> <text>An extreme crisis;</text> </paragraph> <paragraph num="(2)"> <text>A deviation from the facility's procedure; or</text> </paragraph> <paragraph num="(3)"> <text>A problem in the facility's policy which is correctable by administrative action.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The CEO shall assure that the facility's quality assurance process incorporates a monthly review of any variance permitted in §A of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 25, 1993 (20:21 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation 10D amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D, F amended effective February 14, 2026 (52:23 Md. R. 1139)</annotation> </annotations> </chapter> <chapter num="13" heading="Use of Quiet Room and Use of Seclusion"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the use of quiet rooms and seclusion in all facilities as defined in Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland. These regulations are supplemental to any other applicable law and regulation. In the event of conflict between these regulations and any other regulations or laws, the more stringent apply.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Chief executive officer (CEO)” means the individual responsible for the overall management of a facility.</text> </paragraph> <paragraph num="(2)"> <text>“Clinical director” means the psychiatrist in charge of the clinical care of all psychiatric patients in that facility.</text> </paragraph> <paragraph num="(3)"> <text>“Emergency situation” means any situation in which a patient's behavior poses a serious and imminent danger to the physical safety of self or others.</text> </paragraph> <paragraph num="(4)"> <text>“Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute general hospital that does not have a separately identified inpatient psychiatric service.</text> </paragraph> <paragraph num="(5)"> <text>“Patient” means an individual receiving services for a mental disorder in a facility and includes any student receiving care and treatment in that facility.</text> </paragraph> <paragraph num="(6)"> <text>“Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>Prone Restraint.</text> <paragraph num="(a)"> <text>“Prone restraint” means restricting the free movement of all or a portion of a patient’s body through the use of physical force or mechanical devices while the patient is in a prone position.</text> </paragraph> <paragraph num="(b)"> <text>“Prone restraint” does not mean a technique for transitioning a patient to a restraint position that involves momentarily placing the individual face down.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Quiet room” means an unlocked room that patients are not physically prevented from leaving, which is designated for patients' voluntary use to allow them time out of the company of other patients.</text> </paragraph> <paragraph num="(9)"> <text>“Registered nurse” means an individual who is licensed to practice registered nursing under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Seclusion” means the involuntary confinement of a patient under the direction of a physician or registered nurse alone in a room which a patient is physically prevented from leaving.</text> </paragraph> <paragraph num="(11)"> <text>“Trauma-informed care” means mental health treatment that includes:</text> <paragraph num="(a)"> <text>An appreciation for the high prevalence of trauma experienced by individuals receiving mental health services;</text> </paragraph> <paragraph num="(b)"> <text>An understanding of the neurological, biological, psychological, and social effects of trauma and violence, including sexual abuse and exploitation, on an individual; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Treatment team” means the patient's mental health professional treatment team as defined in COMAR 10.21.03.02C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of Seclusion."> <paragraph num="A."> <text>Staff authorized under the provisions of Regulation .04C of this chapter may use seclusion:</text> <paragraph num="(1)"> <text>Only during an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury; and</text> </paragraph> <paragraph num="(2)"> <text>If ordered by a physician in writing; or</text> </paragraph> <paragraph num="(3)"> <text>If at the direction of a registered nurse if a physician's order is obtained within 2 hours of the action.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff may not use seclusion:</text> <paragraph num="(1)"> <text>As a mode or course of treatment;</text> </paragraph> <paragraph num="(2)"> <text>As punishment, coercion, discipline, or retaliation;</text> </paragraph> <paragraph num="(3)"> <text>For the convenience of staff;</text> </paragraph> <paragraph num="(4)"> <text>To prevent damage or destruction to property; or</text> </paragraph> <paragraph num="(5)"> <text>To prevent serious disruption of the therapeutic environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall conduct seclusion:</text> <paragraph num="(1)"> <text>In a humane, safe, and effective manner;</text> </paragraph> <paragraph num="(2)"> <text>Without intent to harm or create undue discomfort to the patient; and</text> </paragraph> <paragraph num="(3)"> <text>For the shortest possible length of time, regardless of the length of time in the physician's order.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staff authorized under the provisions of Regulation .04C of this chapter may order the use of seclusion only if that staff person, following a clinical evaluation of the patient, determines that:</text> <paragraph num="(1)"> <text>The patient's behavior poses an emergency situation; and</text> </paragraph> <paragraph num="(2)"> <text>Less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The approaches referred to in §D(2) of this regulation may include, but are not limited to:</text> <paragraph num="(1)"> <text>Clinical interventions;</text> </paragraph> <paragraph num="(2)"> <text>Quiet room;</text> </paragraph> <paragraph num="(3)"> <text>Medication or medications;</text> </paragraph> <paragraph num="(4)"> <text>Deescalation techniques;</text> </paragraph> <paragraph num="(5)"> <text>Trauma-informed care interventions;</text> </paragraph> <paragraph num="(6)"> <text>Calling the hospital's response team for assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Consulting the patient's care plan for personalized strategies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedures in the Use of Seclusion."> <paragraph num="A."> <text>A facility shall have a written policy specifying the method used to ensure that a patient whose primary language or method of communication is nonverbal is able to effectively communicate distress during a seclusion.</text> </paragraph> <paragraph num="B."> <text>A facility shall ensure that all staff at the facility who are authorized to participate in a seclusion of patients are trained in the method specified in the written policy in accordance with §A(1) of this regulation.</text> </paragraph> <paragraph num="C."> <text>A physician who is responsible either for the care of the patient or for assessment of the appropriateness of seclusion or, when the appropriate physician is not readily available to assess the patient, a registered nurse shall conduct a clinical evaluation of the patient to determine whether an emergency situation is present.</text> </paragraph> <paragraph num="D."> <text>Before instituting seclusion, the physician or registered nurse shall assess whether less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others.</text> </paragraph> <paragraph num="E."> <text>When a physician, as identified in §C of this regulation, is immediately available, the physician shall be responsible for determining a patient's need for seclusion and make the decision whether to seclude.</text> </paragraph> <paragraph num="F."> <text>Authorization in the Absence of a Physician.</text> <paragraph num="(1)"> <text>When a physician, as identified in §C of this regulation, is not immediately available, a registered nurse shall determine a patient's need for seclusion and may initiate and direct the use of seclusion.</text> </paragraph> <paragraph num="(2)"> <text>Within 2 hours of the implementation of the seclusion, a physician shall give a written or verbal order for any seclusion initiated by a registered nurse and, at that time, shall make the clinical determination to continue or discontinue the seclusion.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Placement of a Patient in a Seclusion Room."> <paragraph num="A."> <text>When possible, staff shall advise a patient, in a nonthreatening manner, that continuation of a specific behavior may result in the use of seclusion.</text> </paragraph> <paragraph num="B."> <text>When a physician or registered nurse determines that the use of seclusion is appropriate, staff involved shall make a reasonable effort to verbally persuade the patient to enter the seclusion room.</text> </paragraph> <paragraph num="C."> <text>For patient's safety and the safety of others:</text> <paragraph num="(1)"> <text>Staff shall place the patient in the seclusion room in as dignified a manner as the situation permits, using the least amount of physical force necessary;</text> </paragraph> <paragraph num="(2)"> <text>As necessary, additional staff shall participate in the placement of a patient in seclusion;</text> </paragraph> <paragraph num="(3)"> <text>The patient shall be free from prone restraint; and</text> </paragraph> <paragraph num="(4)"> <text>The patient shall be free from restraint that:</text> <paragraph num="(a)"> <text>Applies pressure to the individual’s back;</text> </paragraph> <paragraph num="(b)"> <text>Obstructs the airway of the individual or impairs the individual’s ability to breathe;</text> </paragraph> <paragraph num="(c)"> <text>Obstructs a staff member’s view of the individual’s face; or</text> </paragraph> <paragraph num="(d)"> <text>Restricts the individual’s ability to communicate distress.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Unless a physician or registered nurse determines that it is unsafe to do so, staff shall permit the patient to wear all or a portion of the patient's own clothes or another form of attire.</text> </paragraph> <paragraph num="E."> <text>Staff shall search the patient for potentially harmful objects.</text> </paragraph> <paragraph num="F."> <text>If staff determines a need for objects to be removed pursuant to §E of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects.</text> </paragraph> <paragraph num="G."> <text>Unless contraindicated for safety reasons, staff shall permit the patient to wear eyeglasses, hearing aids, dentures, or prosthetic devices.</text> </paragraph> <paragraph num="H."> <text>Staff shall inspect the seclusion room for potentially dangerous conditions and, as appropriate, shall fully secure the room.</text> </paragraph> <paragraph num="I."> <text>If a patient is confined to a room in a manner that meets the definition of seclusion in accordance with Regulation .02B of this chapter, the patient is considered to be subject to seclusion, regardless of whether the room used is typically used as a seclusion room.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Clinical Interventions During Seclusion."> <paragraph num="A."> <text>While the patient is secluded, in order to provide appropriate clinical care, at a minimum, clinically trained staff shall:</text> <paragraph num="(1)"> <text>Observe the patient at least every 15 minutes, and document each observation by the observer;</text> </paragraph> <paragraph num="(2)"> <text>Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, at least hourly, make and document personal contact with the patient for the purpose of determining if the patient has any special needs which need attention;</text> </paragraph> <paragraph num="(3)"> <text>Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, offer or provide the following:</text> <paragraph num="(a)"> <text>Toilet facilities, at least every 2 hours;</text> </paragraph> <paragraph num="(b)"> <text>Bathing and oral hygiene, at least once during a 24-hour period;</text> </paragraph> <paragraph num="(c)"> <text>Meals, at the regularly scheduled hours and under the supervision of nursing personnel; and</text> </paragraph> <paragraph num="(d)"> <text>Fluids, at least every 2 hours; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>As clinically indicated, record temperature, pulse, blood pressure, and respirations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At least once every 2 hours, a physician or registered nurse shall assess the appropriateness of continuing the seclusion and document the factors supporting the assessment in the patient's medical record.</text> </paragraph> <paragraph num="C."> <text>When the patient's behavior no longer places the patient or others in serious threat of violence or injury, the patient shall be released from seclusion.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations on Seclusion and Continuous Seclusion."> <paragraph num="A."> <text>Staff may not initiate “standing” or “as needed” orders for seclusion.</text> </paragraph> <paragraph num="B."> <text>Each order for seclusion, used for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, may only be renewed in accordance with the following limits not to exceed 24 hours total:</text> <paragraph num="(1)"> <text>Four hours for adults 18 years of age or older;</text> </paragraph> <paragraph num="(2)"> <text>Two hours for children and adolescents 9 to 17 years of age; or</text> </paragraph> <paragraph num="(3)"> <text>One hour for children under 9 years of age.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After 24 hours, before writing a new order for the use of seclusion for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, a physician must:</text> <paragraph num="(1)"> <text>See, assess, and conduct a face-to-face evaluation of the patient to determine whether continuous seclusion is appropriate; and</text> </paragraph> <paragraph num="(2)"> <text>Document in the patient's medical record the observed behavior that confirms that the patient, if released from seclusion, would continue to present a danger to self or others;</text> </paragraph> <paragraph num="(3)"> <text>Follow all requirements outlined in this chapter, including but not limited to §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Obtain the authorization of the clinical director or the clinical director's physician designee, neither of whom may be the treating physician.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon a request from a patient's treating physician, prior to authorizing continued seclusion, in accordance with §C(4) of this regulation, the clinical director or the clinical director's designee shall perform a face-to-face evaluation of the patient who is secluded.</text> </paragraph> <paragraph num="E."> <text>Following the initial 24 hours of seclusion authorized under §C of this regulation, additional periods of restraint, not to exceed 24 hours each, may be authorized only if the seclusion is provided in accordance with §§B—D of this regulation.</text> </paragraph> <paragraph num="F."> <text>Treatment Team Involvement.</text> <paragraph num="(1)"> <text>Minimally, at regularly scheduled meetings, the patient's treatment team shall review the use of seclusion for that patient.</text> </paragraph> <paragraph num="(2)"> <text>Within 5 working days from the initiation of continuous seclusion, regardless of whether the patient remains in seclusion, the treatment team shall:</text> <paragraph num="(a)"> <text>When applicable, review the appropriateness of the continued use of seclusion;</text> </paragraph> <paragraph num="(b)"> <text>Establish and implement a plan to eliminate the need for further seclusion; and</text> </paragraph> <paragraph num="(c)"> <text>Identify a team member who shall explain to the patient the potential risks and benefits of continuous seclusion.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Documentation."> <paragraph num="A."> <text>Seclusion Orders. A physician shall:</text> <paragraph num="(1)"> <text>To initiate the use of seclusion:</text> <paragraph num="(a)"> <text>Enter an order in the patient's medical record; or</text> </paragraph> <paragraph num="(b)"> <text>Authorize an order to be written by a registered nurse on the physician's order sheet in the patient's medical record:</text> <paragraph num="(i)"> <text>Indicating that physician's verbal order for seclusion; or</text> </paragraph> <paragraph num="(ii)"> <text>Directing the release of the patient and the rationale for that release;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Countersign all verbal orders within 24 hours of the order's being written; and</text> </paragraph> <paragraph num="(3)"> <text>Include in the order for seclusion:</text> <paragraph num="(a)"> <text>The date and time that the order was written;</text> </paragraph> <paragraph num="(b)"> <text>The maximum duration of seclusion from the time that the seclusion was initiated;</text> </paragraph> <paragraph num="(c)"> <text>The specific rationale for seclusion;</text> </paragraph> <paragraph num="(d)"> <text>Special precautions, if any, to safeguard the patient;</text> </paragraph> <paragraph num="(e)"> <text>The physician's signature; and</text> </paragraph> <paragraph num="(f)"> <text>In the case of a verbal order, the names of both the ordering physician and the registered nurse who received the verbal order.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>As soon as possible after implementation, but not later than the close of the shift, staff shall:</text> <paragraph num="(1)"> <text>Document the implementation of seclusion in the patient's medical record; and</text> </paragraph> <paragraph num="(2)"> <text>Include in the documentation the following information:</text> <paragraph num="(a)"> <text>A description of the specific behavior leading to seclusion;</text> </paragraph> <paragraph num="(b)"> <text>Whether and which less restrictive techniques were used, and, if not, why not;</text> </paragraph> <paragraph num="(c)"> <text>Whether a formal call for facility staff response was required, the names of staff assisting in the seclusion, and the circumstances while secluding the patient;</text> </paragraph> <paragraph num="(d)"> <text>The readily observable physical condition of the patient;</text> </paragraph> <paragraph num="(e)"> <text>The date and time of the seclusion and signature of the recorder;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was permitted to wear the patient's own clothes or other attire and, if not, the reason or reasons for this; and</text> </paragraph> <paragraph num="(g)"> <text>A description of any physical injury to either the patient or others resulting from placement of the patient in seclusion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>While a patient is in seclusion, staff shall document in the patient's medical record the clinical interventions employed, including those listed in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Release from Seclusion.</text> <paragraph num="(1)"> <text>When a physician clinically determines that a patient is to be released from seclusion, the physician shall:</text> <paragraph num="(a)"> <text>Direct termination of the seclusion with or without a physician's order; and</text> </paragraph> <paragraph num="(b)"> <text>If verbally ordering the release, write, sign, and date the note not later than 24 hours after a verbal order to release.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When a registered nurse clinically determines that the release of the patient before the maximum period specified on a physician's order is appropriate, the registered nurse shall:</text> <paragraph num="(a)"> <text>Order termination of the seclusion with or without a physician's order, unless the physician's order specifically requires physician concurrence with the termination; and</text> </paragraph> <paragraph num="(b)"> <text>Document, sign, and date the rationale for the termination of seclusion in the patient's record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Use of Quiet Room."> <paragraph num="A."> <text>Patient Request.</text> <paragraph num="(1)"> <text>A patient may request the use of a quiet room and, unless clinically contraindicated, may be granted use of a quiet room.</text> </paragraph> <paragraph num="(2)"> <text>Unless staff terminates use of the quiet room for clinical reasons, the patient may terminate self-initiated use of the quiet room at any time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff Request.</text> <paragraph num="(1)"> <text>When staff, permitted by the facility to initiate and terminate use of a quiet room, determine that the use of the quiet room is clinically indicated, staff may request that a patient voluntarily enter into the quiet room.</text> </paragraph> <paragraph num="(2)"> <text>Staff may not coerce a patient into entering the quiet room.</text> </paragraph> <paragraph num="(3)"> <text>When the patient enters the quiet room, staff shall discuss with the patient:</text> <paragraph num="(a)"> <text>The recommended length of stay in the quiet room;</text> </paragraph> <paragraph num="(b)"> <text>The behaviors expected of the patient before and upon return to the milieu; and</text> </paragraph> <paragraph num="(c)"> <text>The primary interventions to be initiated if the use of the quiet room is terminated by the patient before the time recommended by staff or is determined to be ineffective.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall determine the need for removal of any harmful objects in the room or from the patient.</text> </paragraph> <paragraph num="D."> <text>If staff determine a need for objects to be removed pursuant to §C of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects.</text> </paragraph> <paragraph num="E."> <text>While a quiet room is in use, the staff shall assure that the quiet room door is not locked or in a position that prevents a patient from exiting the room voluntarily.</text> </paragraph> <paragraph num="F."> <text>Observation and Documentation. Staff shall:</text> <paragraph num="(1)"> <text>Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room;</text> </paragraph> <paragraph num="(2)"> <text>When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and</text> </paragraph> <paragraph num="(3)"> <text>At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A physician shall review the use of the quiet room after 6 hours and, if use of the quiet room is continued, at least every 24 hours after that.</text> </paragraph> <paragraph num="H."> <text>Use of a quiet room may be terminated at any time:</text> <paragraph num="(1)"> <text>Upon the decision of the patient; or</text> </paragraph> <paragraph num="(2)"> <text>As clinically determined by staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Assurance."> <paragraph num="A."> <text>The clinical director or the clinical director's designee shall review daily all uses of seclusion and investigate unusual or possibly unwarranted patterns of use.</text> </paragraph> <paragraph num="B."> <text>The physician involved in the seclusion may not function in the capacity outlined in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>A facility shall identify a committee to review periodically, but not less than quarterly, the use of seclusion to assure that the standards maintained by the facility are, at a minimum, consistent with this chapter.</text> </paragraph> <paragraph num="D."> <text>Staff who implement orders for seclusion:</text> <paragraph num="(1)"> <text>Shall have documented annual training in the proper use of seclusion including training for special populations which include, but are not limited to, children and the elderly;</text> </paragraph> <paragraph num="(2)"> <text>Shall have documented annual training in trauma-informed care and demonstrate competency in providing trauma-informed care services;</text> </paragraph> <paragraph num="(3)"> <text>May not implement orders for seclusion until trained by the facility to do so unless, in an emergency situation, the safety of the patient or others is threatened.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Standards for a Seclusion Room.</text> <paragraph num="(1)"> <text>The CEO or the CEO's designee is responsible for assuring that the seclusion room or rooms in the facility are maintained in accordance with acceptable standards for hygiene and safety.</text> </paragraph> <paragraph num="(2)"> <text>Staff shall ensure that each seclusion room:</text> <paragraph num="(a)"> <text>Unless clinically contraindicated and the record reflects that assessment, has a mattress provided;</text> </paragraph> <paragraph num="(b)"> <text>At the beginning of each shift, is inspected and maintained for proper temperature, ventilation, safety, lighting, sanitation, and freedom from dangerous conditions; and</text> </paragraph> <paragraph num="(c)"> <text>Is fitted with a means of observation that affords staff a view of the entire room and permits clinical staff periodically to observe the patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>If restraint is used in conjunction with seclusion, staff shall also comply with COMAR 10.21.12.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Procedures Pertaining to Complaints."> <text>Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Variance with Standards."> <paragraph num="A."> <text>Excluding the prohibition described in §B of this regulation, staff may not vary from the standards identified in this chapter unless the variation is for an extreme crisis.</text> </paragraph> <paragraph num="B."> <text>There may not be any variance with standards established in:</text> <paragraph num="(1)"> <text>This regulation;</text> </paragraph> <paragraph num="(2)"> <text>Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Regulation .05B—E, G, and I of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Regulation .07A of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Regulation .10A, D, E(1), and F of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff shall document, on the facility's variance report, a variance with standards permitted under this chapter.</text> </paragraph> <paragraph num="D."> <text>The CEO shall rule on and document each variance permitted in §A of this regulation to determine whether the variance was:</text> <paragraph num="(1)"> <text>An extreme crisis;</text> </paragraph> <paragraph num="(2)"> <text>A deviation from the facility's procedure; or</text> </paragraph> <paragraph num="(3)"> <text>A problem in the facility's policy which is correctable by administrative action.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The CEO shall assure that the facility's quality assurance process incorporates a monthly review of any variance permitted in §A of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 25, 1993 (20:21 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I adopted effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D, F amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective November 24, 2025 (52:23 Md. R. 1139)</annotation> </annotations> </chapter> <chapter num="14" heading="Resident Grievance System"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the administrative process to be used to ensure that the rights of residents residing in the Behavioral Health Administration facilities are protected. Although the residents and the legal assistance providers ultimately shall decide whether to invoke the Resident Grievance System, it is the intent that the Resident Grievance System provide a fair, efficient, and complete mechanism for receiving, investigating, and resolving resident complaints, including rights issues, in a timely manner.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Central Review Committee” means the Maryland Department of Health (MDH) staff or their respective designees in the following positions:</text> <paragraph num="(a)"> <text>The Director of the Behavioral Health Administration;</text> </paragraph> <paragraph num="(b)"> <text>The clinical director of the Behavioral Health Administration; and</text> </paragraph> <paragraph num="(c)"> <text>The Director of the Resident Grievance System.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Chief executive officer (CEO)” means the individual appointed by the Director of the Behavioral Health Administration to act on the Director’s behalf in the overall management of a Behavioral Health Administration facility.</text> </paragraph> <paragraph num="(3)"> <text>“Coe consent decree” means the legally binding consent decree in Coe v. Hughes ordered by the United States District Court for Maryland which sets forth the legal rights of Mental Hygiene Administration facility residents with respect to the provision of legal and other related services by the legal assistance provider and the rights advisor.</text> </paragraph> <paragraph num="(4)"> <text>“Department (MDH)” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Director of Resident Grievance System” means the individual designated by the Deputy Secretary of Public Health Services to supervise the rights advisors and to perform the duties required to implement the Resident Grievance System.</text> </paragraph> <paragraph num="(6)"> <text>“Facility” means an inpatient or residential institution that is owned or directly operated by the Behavioral Health Administration.</text> </paragraph> <paragraph num="(7)"> <text>“Grievance” means a written or oral statement, as authorized in Regulation .05B of this chapter, alleging that a:</text> <paragraph num="(a)"> <text>Resident's rights have been unfairly limited or violated or are likely to be violated in the immediate future;</text> </paragraph> <paragraph num="(b)"> <text>Resident has been abused, neglected, or mistreated; or</text> </paragraph> <paragraph num="(c)"> <text>Facility has acted in an illegal or improper manner with respect to a resident or a group of residents.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Grievant” means a resident on whose behalf a grievance is filed, whether initiated by the resident, an employee of a facility, a family member of the resident, or an interested person.</text> </paragraph> <paragraph num="(9)"> <text>“Legal assistance provider (LAP)” means the lawyers and legally trained individuals who work under the lawyers' supervision who are responsible for providing legal services in accordance with the Coe consent decree.</text> </paragraph> <paragraph num="(10)"> <text>“Resident” means an individual who resides in a Behavioral Health Administration inpatient or residential facility or who was released or discharged from the facility within the past 90 days.</text> </paragraph> <paragraph num="(11)"> <text>“Resident Grievance System (RGS)” means the accessible administrative mechanism designed to protect a resident's rights through the investigation, processing, and resolution of grievances and implementation of the resolution.</text> </paragraph> <paragraph num="(12)"> <text>“Residents' rights committee” means a committee composed of at least nine members who are representative of:</text> <paragraph num="(a)"> <text>Facility staff;</text> </paragraph> <paragraph num="(b)"> <text>Residents, former residents, and residents' family members; and</text> </paragraph> <paragraph num="(c)"> <text>Advocacy groups.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Rights advisor” means an individual assigned as a resident advocate to implement the RGS.</text> </paragraph> <paragraph num="(14)"> <text>“Rights issue” means an alleged violation of a resident's rights guaranteed by federal and State constitutions, statutes, regulations, common law, or policies of the Maryland Department of Health and the facility.</text> </paragraph> <paragraph num="(15)"> <text>“Unit director” means an individual who has administrative authority within an organizational component of a facility.</text> </paragraph> <paragraph num="(16)"> <text>“Working day” means every day excluding Saturdays, Sundays, and holidays on which State offices are closed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Policies of the Resident Grievance System."> <paragraph num="A."> <text>When invoked, and when the process provides a fair, efficient, and complete remedy for allegations of rights violations, a grievant, when involved, the grievant's LAP, and the facility shall follow the four-stage administrative procedure outlined in this chapter.</text> </paragraph> <paragraph num="B."> <text>Through a timely process of systematic and orderly stages as outlined in this chapter, all those involved in the RGS process shall give grievances a fair consideration.</text> </paragraph> <paragraph num="C."> <text>To ensure that the rights of residents in the Behavioral Health Administration facilities are fully protected and that allegations of rights violations are investigated and resolved, the Director of the RGS shall provide an accessible internal system.</text> </paragraph> <paragraph num="D."> <text>The rights advisor shall investigate grievances:</text> <paragraph num="(1)"> <text>Promptly, impartially, and with the least disruption to the grievant's treatment plan; and</text> </paragraph> <paragraph num="(2)"> <text>Without abridging the right of a grievant to have the grievance process transpire within the required time frames or be completed within 65 working days.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Except in accordance with the provisions outlined in Regulations .06—.10 of this chapter, and except to the extent necessary to conduct an investigation, report on the results of the investigation, and resolve the grievance, the individuals involved in the investigation of a grievance shall keep confidential the information gathered or disclosed during the course of the investigation.</text> </paragraph> <paragraph num="F."> <text>If a LAP is involved, the rights advisor shall provide to the LAP reports on the status of the grievances processed, the administrative decisions of the RGS at each stage, and the remaining RGS stages scheduled or to be scheduled.</text> </paragraph> <paragraph num="G."> <text>The Department may not subject an individual to discipline, harassment, or retribution for filing a grievance, pursuing a remedy for a grievance or, in cases when a grievance is substantiated, obtaining corrective action through the RGS.</text> </paragraph> <paragraph num="H."> <text>A resident who has concerns, including grievances, may request resolution from:</text> <paragraph num="(1)"> <text>The treatment team; or</text> </paragraph> <paragraph num="(2)"> <text>If the resident chooses not to involve the treatment team, the RGS.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Except as provided in §J of this regulation, a grievant may terminate a grievance through the RGS at any time, either orally or in writing. If the termination is oral, the rights advisor shall document the oral termination of a grievance in the record of the grievance that is maintained by the rights advisor.</text> </paragraph> <paragraph num="J."> <text>If a grievant seeks to terminate a grievance that alleges abuse or serious harm or the potential for abuse or serious harm, the rights advisor shall notify the CEO and the Director of the RGS, either of whom may determine whether the investigation may continue.</text> </paragraph> <paragraph num="K."> <text>Within the time periods specified in Regulations .06—.09 of this chapter, the rights advisor shall file, investigate, and review a grievance, render a decision, and notify the grievant.</text> </paragraph> <paragraph num="L."> <text>In cases in which grievances alleging abuse have been substantiated, the facility shall take corrective action immediately.</text> </paragraph> <paragraph num="M."> <text>If time periods for stages lapse and extensions are denied, the rights advisor shall proceed with the next stage of the grievance.</text> </paragraph> <paragraph num="N."> <text>Those involved in the RGS process shall ensure that they complete the process within 65 working days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Duties of the Rights Advisors and Director of the RGS."> <paragraph num="A."> <text>The rights advisor shall:</text> <paragraph num="(1)"> <text>Investigate all complaints in a professionally appropriate manner;</text> </paragraph> <paragraph num="(2)"> <text>Attempt to resolve grievances fairly and thoroughly;</text> </paragraph> <paragraph num="(3)"> <text>Prepare written reports for each grievance investigated;</text> </paragraph> <paragraph num="(4)"> <text>Maintain the RGS reports;</text> </paragraph> <paragraph num="(5)"> <text>Attempt to identify residents who may benefit from services offered by the LAP and:</text> <paragraph num="(a)"> <text>Refer the residents identified to the LAP; and</text> </paragraph> <paragraph num="(b)"> <text>Advise the LAP of the referrals;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Investigate abuse allegations, even though the State police and the facility also may be conducting an investigation of the same allegations;</text> </paragraph> <paragraph num="(7)"> <text>Monitor any corrective action used to resolve grievances, and:</text> <paragraph num="(a)"> <text>Notify the CEO if corrective action has not been taken; and</text> </paragraph> <paragraph num="(b)"> <text>If corrective action has not been taken by the CEO within a reasonable period of time, notify the RGS Director;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>When a rights advisor discusses a grievance with a grievant, inform the grievant that, if the grievant requests, the rights advisor is available to attend and advocate for the grievant before the Behavioral Health Administration committees, boards, and tribunals;</text> </paragraph> <paragraph num="(9)"> <text>Inform the grievant of the right to appeal a decision during any stage of the grievance process, and if a grievant wishes to appeal:</text> <paragraph num="(a)"> <text>Upon request, file an appeal on behalf of the grievant;</text> </paragraph> <paragraph num="(b)"> <text>Advise the grievant that the resident may be represented by a LAP following the completion of stage 2 of the grievance procedure; and</text> </paragraph> <paragraph num="(c)"> <text>With the grievant's consent, attend and advocate in the best possible manner for the grievant on appeal, except in cases when, as a result of the rights advisor's professional judgment, the grievant's case is determined to be frivolous; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>In cases when, as a result of the rights advisor's professional judgment, the grievant's case is determined to be frivolous, forward the grievance to the Director of the RGS.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Director of the RGS shall:</text> <paragraph num="(1)"> <text>If the rights advisor for a facility is not available for 2 or more consecutive working days, designate an alternate rights advisor;</text> </paragraph> <paragraph num="(2)"> <text>Arrange for the provision of appropriate training to:</text> <paragraph num="(a)"> <text>The rights advisors; and</text> </paragraph> <paragraph num="(b)"> <text>Facility staff, regarding relevant legal documents, including Department policies and procedures, related to residents' rights;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a rights advisor informs the Director of the RGS that the CEO has not taken corrective action within a reasonable period of time, notify the Director of the Behavioral Health Administration, who shall ensure that grievance resolution, at any level, is implemented promptly;</text> </paragraph> <paragraph num="(4)"> <text>If a rights advisor informs the Director of the RGS that the rights advisor has determined that a grievant's grievance is frivolous, review the determination, and, following that review, if the Director of the RGS:</text> <paragraph num="(a)"> <text>Agrees with the rights advisor and a LAP is involved, forward the grievance to the LAP, who may request continuation of the RGS process; or</text> </paragraph> <paragraph num="(b)"> <text>Does not agree with the rights advisor, notify:</text> <paragraph num="(i)"> <text>The rights advisor to proceed with the grievance; and</text> </paragraph> <paragraph num="(ii)"> <text>The LAP of the action taken; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Make appropriate arrangements to ensure that a rights advisor shall:</text> <paragraph num="(a)"> <text>Be independent to discharge responsibilities;</text> </paragraph> <paragraph num="(b)"> <text>As necessary to conduct an investigation, have the access to facility staff, the LAP, and others relevant to the investigation; and</text> </paragraph> <paragraph num="(c)"> <text>Have access to a resident's medical records:</text> <paragraph num="(i)"> <text>Excluding conditions outlined in Regulation .05C(2)(c) of this chapter, subject to the provisions in Health-General Article, §10-701(d), Annotated Code of Maryland, or any other applicable provisions of law; and</text> </paragraph> <paragraph num="(ii)"> <text>Immediately, in cases of allegations of abuse or neglect of the resident.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedures for Filing a Grievance."> <paragraph num="A."> <text>A facility shall provide for a direct and effective means of communication between the residents and the rights advisor, including but not limited to communication by telephone and in person.</text> </paragraph> <paragraph num="B."> <text>The following may present a grievance to a rights advisor:</text> <paragraph num="(1)"> <text>A resident;</text> </paragraph> <paragraph num="(2)"> <text>An employee of a facility;</text> </paragraph> <paragraph num="(3)"> <text>A resident's family member;</text> </paragraph> <paragraph num="(4)"> <text>A LAP; or</text> </paragraph> <paragraph num="(5)"> <text>An interested person.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the grievance is initiated orally, the rights advisor shall:</text> <paragraph num="(1)"> <text>Assist in completing a grievance form and, if possible, obtain the grievant's signature; and</text> </paragraph> <paragraph num="(2)"> <text>If a grievance is initiated on the resident's behalf:</text> <paragraph num="(a)"> <text>Contact the resident to determine if the resident wants the matter to be investigated;</text> </paragraph> <paragraph num="(b)"> <text>Counsel the resident about the resident's rights regarding the grievance procedure; and</text> </paragraph> <paragraph num="(c)"> <text>If the resident elects to proceed with the grievance, obtain the resident's written consent to investigate or, if the resident does not sign, document the rationale for not obtaining the resident's signature.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Pursuant to §E of this regulation, a resident about whom a grievance is initiated may elect not to file a grievance or may withdraw a grievance before disclosure of identity of the resident is made, if the resident notifies the rights advisor of the withdrawal or election not to file.</text> </paragraph> <paragraph num="E."> <text>If a resident elects not to file a grievance or if the grievant has requested that a grievance be withdrawn or is unable or unwilling to respond, the rights advisor shall proceed with the investigation if the:</text> <paragraph num="(1)"> <text>Rights advisor believes that the:</text> <paragraph num="(a)"> <text>Situation has resulted or may result in serious harm to the grievant or other residents;</text> </paragraph> <paragraph num="(b)"> <text>Complaint appears to have substantial merit and requires further investigation;</text> </paragraph> <paragraph num="(c)"> <text>Grievance highlights issues which may affect a substantial number of other residents; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Director of the RGS grants approval to proceed.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The rights advisor shall keep the identity of the grievant confidential except when:</text> <paragraph num="(1)"> <text>Confidentiality interferes with investigation or resolution of the grievance; or</text> </paragraph> <paragraph num="(2)"> <text>Good cause requires disclosure of the grievant's identity.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the rights advisor determines that disclosure of the identity of the grievant is necessary according to the provisions of §F of this regulation, the rights advisor shall:</text> <paragraph num="(1)"> <text>Inform the grievant of the disclosure; and</text> </paragraph> <paragraph num="(2)"> <text>Assure that disclosure be limited to that which is necessary to investigate, assess, and resolve the grievance.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A facility employee shall report immediately to the CEO and the rights advisor all physical or sexual abuse as defined in Health-General Article, §10-705(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="I."> <text>A facility employee shall file a grievance on behalf of a resident when, in that employee's reasonable judgment, there exist instances of rights violations, mental, physical, or sexual abuse, neglect or mistreatment, or instances when the facility has acted in an illegal or improper manner with respect to a resident or a group of residents.</text> </paragraph> <paragraph num="J."> <text>If requested by a resident, a facility employee shall:</text> <paragraph num="(1)"> <text>Notify the rights advisor immediately of the request; or</text> </paragraph> <paragraph num="(2)"> <text>If the rights advisor is not immediately available:</text> <paragraph num="(a)"> <text>Leave a written or a tape-recorded message concerning the request; and</text> </paragraph> <paragraph num="(b)"> <text>Contact the Director of the RGS for issues which require an immediate response.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Except for good cause, the rights advisor shall process grievances in the order received, if first priority is given to cases alleging:</text> <paragraph num="(1)"> <text>Abuse;</text> </paragraph> <paragraph num="(2)"> <text>Neglect; or</text> </paragraph> <paragraph num="(3)"> <text>Mistreatment.</text> </paragraph> </paragraph> <paragraph num="L."> <text>If a grievance alleges abuse:</text> <paragraph num="(1)"> <text>The rights advisor shall investigate;</text> </paragraph> <paragraph num="(2)"> <text>The CEO of the facility shall refer the grievance to the Maryland State Police or the appropriate law enforcement agency for investigation; and</text> </paragraph> <paragraph num="(3)"> <text>For residents up to 18 years old, the CEO shall refer the grievance to the local department of social services.</text> </paragraph> </paragraph> <paragraph num="M."> <text>In addition to the requirements outlined in §L of this regulation, the CEO may:</text> <paragraph num="(1)"> <text>Conduct an investigation of the alleged abuse case; and</text> </paragraph> <paragraph num="(2)"> <text>Refer the alleged abuse case to the treatment team.</text> </paragraph> </paragraph> <paragraph num="N."> <text>If grievances refer to the same incident:</text> <paragraph num="(1)"> <text>The rights advisor may treat the grievances as one issue; and</text> </paragraph> <paragraph num="(2)"> <text>For cases involving more than one grievant, the rights advisor shall send separate notices and copies of decisions and appeals of decisions to each grievant.</text> </paragraph> </paragraph> <paragraph num="O."> <text>If the rights advisor is the subject of the grievance, the rights advisor shall inform the grievant of the name, mailing address, and telephone number of the Director of the RGS who shall:</text> <paragraph num="(1)"> <text>Appoint a substitute rights advisor for the purpose of that grievance; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the CEO of the substitute appointment.</text> </paragraph> </paragraph> <paragraph num="P."> <text>The LAP may conduct interviews with residents. When the LAP refers a case that results in a grievance or is asked by the grievant for representation, the LAP:</text> <paragraph num="(1)"> <text>Shall inform the grievant that the LAP may not represent the grievant in the RGS process until stage 2 of the grievance procedure has been completed;</text> </paragraph> <paragraph num="(2)"> <text>May represent a grievant pursuant to the requirements and limitations outlined in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Shall receive reports from the rights advisor while the investigation is in progress and at the conclusion of each stage.</text> </paragraph> </paragraph> <paragraph num="Q."> <text>For a grievance that is initiated after the effective date of this chapter, and upon request by the grievant, the rights advisor shall provide the grievant or, if involved, the LAP, with the documents that may be considered in making a decision on the grievance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Grievance Procedure Stage 1: Rights Advisor's Role."> <paragraph num="A."> <text>Rights Advisor's Investigation and Mediation.</text> <paragraph num="(1)"> <text>The rights advisor shall respond to the grievance by meeting with:</text> <paragraph num="(a)"> <text>The grievant;</text> </paragraph> <paragraph num="(b)"> <text>The individual filing the grievance, if other than the resident;</text> </paragraph> <paragraph num="(c)"> <text>The grievant's LAP, if involved; and</text> </paragraph> <paragraph num="(d)"> <text>If applicable, any witness to the incident.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except for good cause, the rights advisor shall notify the grievant before reviewing the grievant's medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The rights advisor shall:</text> <paragraph num="(1)"> <text>Determine an appropriate course of action for processing the grievance, which may include, but is not limited to:</text> <paragraph num="(a)"> <text>Interviews in person or by telephone;</text> </paragraph> <paragraph num="(b)"> <text>Requests for documents and correspondence;</text> </paragraph> <paragraph num="(c)"> <text>Notification to the grievant regarding the facility's clinical review panel option if the grievance relates to a grievant's refusal to take medication prescribed for treatment of a mental disorder; and</text> </paragraph> <paragraph num="(d)"> <text>Classification of alleged rights violations in accordance with guidelines developed by the Director of the RGS;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Keep the grievant informed of all steps taken to resolve the grievance; and</text> </paragraph> <paragraph num="(3)"> <text>Render a decision on a grievance within 10 working days of receipt of the grievance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The rights advisor shall make every effort to negotiate, mediate, and resolve the grievance fairly at this stage. If action is taken and the grievant is satisfied, the case is closed.</text> </paragraph> <paragraph num="D."> <text>If, as a result of the rights advisor's professional judgment, a grievance is determined to be frivolous, the rights advisor shall inform the grievant of that finding and of the grievant's right to appeal and the appeal procedure.</text> </paragraph> <paragraph num="E."> <text>If a grievance with merit is not resolved to the grievant's satisfaction, and the grievant wishes to appeal, the rights advisor shall forward a copy of the grievance, including a description of the issues and recommendations, to the unit director as outlined in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="F."> <text>If, in the rights advisor's professional judgment, the nature of the grievance is not frivolous, but the grievance either cannot be substantiated or appears to have no merit, the rights advisor shall:</text> <paragraph num="(1)"> <text>Inform the grievant of the decision and the right to appeal;</text> </paragraph> <paragraph num="(2)"> <text>With the consent of the grievant, assist the grievant in filing an appeal; and</text> </paragraph> <paragraph num="(3)"> <text>Document the findings and forward a copy of the report describing the findings to:</text> <paragraph num="(a)"> <text>The Director of the RGS;</text> </paragraph> <paragraph num="(b)"> <text>The unit director;</text> </paragraph> <paragraph num="(c)"> <text>The grievant;</text> </paragraph> <paragraph num="(d)"> <text>If involved, the grievant's LAP; and</text> </paragraph> <paragraph num="(e)"> <text>The CEO.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If a grievance with merit is resolved to the grievant's satisfaction, the rights advisor shall forward a copy of the decision to:</text> <paragraph num="(1)"> <text>The unit director;</text> </paragraph> <paragraph num="(2)"> <text>The grievant;</text> </paragraph> <paragraph num="(3)"> <text>The CEO; and</text> </paragraph> <paragraph num="(4)"> <text>If involved, the grievant's LAP.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the rights advisor's initial investigation concludes there is substantial risk of serious harm, or there is the potential for serious harm to a grievant if the alleged violation is not remedied promptly:</text> <paragraph num="(1)"> <text>The rights advisor shall inform immediately the:</text> <paragraph num="(a)"> <text>Unit director or the unit director's designee;</text> </paragraph> <paragraph num="(b)"> <text>CEO or the CEO's designee;</text> </paragraph> <paragraph num="(c)"> <text>Director of the RGS; and</text> </paragraph> <paragraph num="(d)"> <text>Director of the Behavioral Health Administration or the Behavioral Health Administration Director’s designee; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The unit director, the CEO, or their respective designees shall:</text> <paragraph num="(a)"> <text>Perform an investigation; and</text> </paragraph> <paragraph num="(b)"> <text>If the grievance is substantiated, develop and implement a solution within 24 hours of receiving the rights advisor's report.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Grievance Procedure Stage 2: Unit Director's Response."> <paragraph num="A."> <text>The unit director shall:</text> <paragraph num="(1)"> <text>Review the rights advisor's report;</text> </paragraph> <paragraph num="(2)"> <text>Discuss the matter with any individual involved; and</text> </paragraph> <paragraph num="(3)"> <text>Within 5 working days of receipt of the report, decide whether to:</text> <paragraph num="(a)"> <text>Accept the rights advisor's report, completely or in part with respect to the facts as found; or</text> </paragraph> <paragraph num="(b)"> <text>Modify or reject the recommendations made by the rights advisor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The unit director shall write and forward a decision to the rights advisor, who shall forward copies to the grievant, the CEO and, if involved, the grievant's LAP.</text> </paragraph> <paragraph num="C."> <text>If the unit director concludes that a grievance has been substantiated and requires remedial action, the unit director immediately shall:</text> <paragraph num="(1)"> <text>Notify the CEO and, if indicated, the clinical director; and</text> </paragraph> <paragraph num="(2)"> <text>Provide a remedy, which may include, but is not limited to:</text> <paragraph num="(a)"> <text>Directing a change in practice; or</text> </paragraph> <paragraph num="(b)"> <text>Seeking approval for changes in policy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If the grievant is:</text> <paragraph num="(1)"> <text>Satisfied with the action taken by the unit director, the grievance ends at this stage; or</text> </paragraph> <paragraph num="(2)"> <text>Dissatisfied with the action taken by the unit director and wishes to pursue the grievance, the rights advisor shall:</text> <paragraph num="(a)"> <text>If the grievant requests the review, request a review by the residents' rights committee, notifying the CEO of the request for the review; and</text> </paragraph> <paragraph num="(b)"> <text>Subsequently request a review by the CEO.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Grievance Procedure Stage 3: CEO's Review with an Optional Review by the Residents' Rights Committee."> <paragraph num="A."> <text>If the grievant requests a review by the residents' rights committee before the CEO's review, the residents' rights committee shall:</text> <paragraph num="(1)"> <text>Meet within 15 working days of receipt of the grievance;</text> </paragraph> <paragraph num="(2)"> <text>Review the information obtained by the rights advisor;</text> </paragraph> <paragraph num="(3)"> <text>Review information presented by the grievant;</text> </paragraph> <paragraph num="(4)"> <text>Review the decision of the unit director;</text> </paragraph> <paragraph num="(5)"> <text>If involved, review information presented by the LAP;</text> </paragraph> <paragraph num="(6)"> <text>Review all relevant data pertaining to the grievance; and</text> </paragraph> <paragraph num="(7)"> <text>Forward written recommendations to the CEO.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A review by the residents' rights committee:</text> <paragraph num="(1)"> <text>May include further investigation into the circumstances of the grievance;</text> </paragraph> <paragraph num="(2)"> <text>May not be limited to consideration of the record of the grievance from prior proceedings; and</text> </paragraph> <paragraph num="(3)"> <text>At the request of the grievant, may be waived.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The rights advisor:</text> <paragraph num="(1)"> <text>Shall notify all interested persons, including involved staff, the grievant, and, if involved, the grievant's LAP of the time and location of the residents' rights committee meetings;</text> </paragraph> <paragraph num="(2)"> <text>Shall present information obtained at prior proceedings;</text> </paragraph> <paragraph num="(3)"> <text>Shall inform the grievant and, if involved, the grievant's LAP of all recommendations made by the residents' rights committee; and</text> </paragraph> <paragraph num="(4)"> <text>May not be present during the residents' rights committee deliberations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>All interested persons including involved staff, the grievant, and, if involved, the grievant's LAP:</text> <paragraph num="(1)"> <text>Shall be invited to attend the residents' rights committee meeting to present information relating to the grievance; and</text> </paragraph> <paragraph num="(2)"> <text>May not be present during residents' rights committee deliberations.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Upon receipt of the residents' rights committee's recommendations, the CEO or the CEO's designee shall:</text> <paragraph num="(1)"> <text>Determine what action, if any, is to be taken; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the residents' rights committee in writing of any action taken.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Completion of time periods specified within stage 3 are dependent upon the following:</text> <paragraph num="(1)"> <text>If the LAP is involved, the CEO or the CEO's designee:</text> <paragraph num="(a)"> <text>Shall respond within 15 working days to the residents' rights committee's recommendations; and</text> </paragraph> <paragraph num="(b)"> <text>May request an oral presentation from the LAP, if the LAP submits a written summary of the presentation before the meeting;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the LAP is not involved, the CEO or the CEO's designee shall respond within 5 working days to the residents' rights committee's recommendations.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The CEO or the CEO's designee shall write and forward a decision to the rights advisor.</text> </paragraph> <paragraph num="H."> <text>The rights advisor shall forward copies of the decision of the CEO or the CEO's designee to:</text> <paragraph num="(1)"> <text>The grievant;</text> </paragraph> <paragraph num="(2)"> <text>If involved, the grievant's LAP;</text> </paragraph> <paragraph num="(3)"> <text>The Director of the RGS;</text> </paragraph> <paragraph num="(4)"> <text>If involved, the residents' rights committee; and</text> </paragraph> <paragraph num="(5)"> <text>The unit director.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the CEO or the CEO's designee substantiates the grievance, the CEO or the CEO's designee shall identify in the decision:</text> <paragraph num="(1)"> <text>The corrective action to provide a complete remedy to the grievant for the violation; and</text> </paragraph> <paragraph num="(2)"> <text>Time frames, consistent with this chapter, for implementing the corrective action.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If the grievant is:</text> <paragraph num="(1)"> <text>Satisfied with the action taken by the CEO or the CEO's designee, the grievance ends at this stage; or</text> </paragraph> <paragraph num="(2)"> <text>Dissatisfied with the decision of the CEO or the CEO's designee, the rights advisor shall inform the grievant of the appeal process to the Central Review Committee.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If requested by the grievant, the rights advisor shall file an appeal to the Central Review Committee within 5 working days after receipt of the decision by the CEO or the CEO's designee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Grievance Procedure Stage 4: Central Review Committee Response."> <paragraph num="A."> <text>The Central Review Committee:</text> <paragraph num="(1)"> <text>Shall meet within 10 working days of receipt of an appeal;</text> </paragraph> <paragraph num="(2)"> <text>Shall review all prior information concerning the grievance;</text> </paragraph> <paragraph num="(3)"> <text>May perform an investigation of the grievance which shall be accomplished within 10 additional working days; and</text> </paragraph> <paragraph num="(4)"> <text>At the request of the grievant, may sequester those who are presenting information to the Committee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For a grievance that is initiated after the effective date of this chapter, if a LAP is representing a grievant, the Central Review Committee, at the request of the grievant, shall:</text> <paragraph num="(1)"> <text>Allow the LAP to be present for argument or while evidence is presented by any other person; and</text> </paragraph> <paragraph num="(2)"> <text>Hear a presentation from the LAP before making a decision, if the LAP submits a written summary of the presentation before the meeting.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Central Review Committee shall write and forward a decision to:</text> <paragraph num="(1)"> <text>The CEO of the facility;</text> </paragraph> <paragraph num="(2)"> <text>The grievant;</text> </paragraph> <paragraph num="(3)"> <text>If involved, the grievant's LAP;</text> </paragraph> <paragraph num="(4)"> <text>The rights advisor; and</text> </paragraph> <paragraph num="(5)"> <text>If involved, the residents' rights committee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the grievant is:</text> <paragraph num="(1)"> <text>Satisfied with the decision of the Central Review Committee, the case is closed; or</text> </paragraph> <paragraph num="(2)"> <text>Dissatisfied with the decision of the Central Review Committee, the rights advisor shall promptly inform the grievant of additional relevant legal services which the grievant may contact.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notification of Status.</text> <paragraph num="(1)"> <text>Within 20 working days, the Central Review Committee, through the Director of the RGS, shall request from the facility CEO a written report of the status of the implementation of the recommendations made during the grievance process.</text> </paragraph> <paragraph num="(2)"> <text>Until the decision is fully implemented, the CEO shall make periodic reports to the Central Review Committee through the RGS Director every 30 days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Resident Grievance System Reports."> <paragraph num="A."> <text>The Director of the RGS shall ensure that RGS reports:</text> <paragraph num="(1)"> <text>May not be released to other persons except as provided within this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Identify the alleged violations, the decision, and the remedy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>With the identity of those involved in the grievance deleted, the Director of the RGS shall ensure that the decisions on all 4th-stage grievances be:</text> <paragraph num="(1)"> <text>Included in the annual report of the RGS Director;</text> </paragraph> <paragraph num="(2)"> <text>Made available for public review at the Department's Resident Grievance System Office;</text> </paragraph> <paragraph num="(3)"> <text>Sent to other rights advisors;</text> </paragraph> <paragraph num="(4)"> <text>Sent to the Deputy Secretary for Public Health Services, the LAP, and members of the Coe Board of Review; and</text> </paragraph> <paragraph num="(5)"> <text>Sent to the Behavioral Health Administration facility CEOs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>With the identity of those involved in the grievance deleted, all decisions with Statewide impact, as determined by the Director of the RGS, shall be:</text> <paragraph num="(1)"> <text>Circulated to those enumerated in §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Sent to all Behavioral Health Administration personnel involved in or affected by the decision.</text> </paragraph> </paragraph> <paragraph num="D."> <text>RGS reports and other documents concerning a grievance may not be placed in the resident's medical record unless otherwise required by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Personnel Provisions."> <paragraph num="A."> <text>A facility may not place the reports of the RGS in an employee's personnel file.</text> </paragraph> <paragraph num="B."> <text>The rights advisor may not be a witness in an agency proceeding against an employee, unless the rights advisor is a first-hand witness to events being reviewed.</text> </paragraph> <paragraph num="C."> <text>If allegations are made against an employee:</text> <paragraph num="(1)"> <text>The rights advisor shall immediately give the employee and the employee's Department head a copy of the information relevant to the allegation; and</text> </paragraph> <paragraph num="(2)"> <text>Within 5 working days of receipt of the information, the employee shall respond, in writing, to the rights advisor assigned to that facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Notice of Grievance Decision.</text> <paragraph num="(1)"> <text>The rights advisor shall give written notice of a grievance decision involving an employee to the director of the division of personnel and the employee's Department head at the facility.</text> </paragraph> <paragraph num="(2)"> <text>The personnel director shall forward a copy of the notice in §D(1) of this regulation to the employee, the employee's supervisor, and the employee's Department head.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Nothing shall prevent a facility from taking appropriate action against an employee for events which come to the attention of the facility through the RGS.</text> </paragraph> <paragraph num="F."> <text>The RGS may not affect employee rights as mandated by State Personnel and Pensions Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="External Legal Action."> <paragraph num="A."> <text>This chapter does not modify the resident's:</text> <paragraph num="(1)"> <text>Legal rights;</text> </paragraph> <paragraph num="(2)"> <text>Access to seek private legal counsel from attorneys not receiving funding for legal assistance from the Maryland Department of Health; or</text> </paragraph> <paragraph num="(3)"> <text>Access to a court.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Resident Grievance System is not governed by the contested case provisions of the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7.5-201, 7.5-205(D), 10-701, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 28, 1994 (21:6 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 26, 1998 (25:2 Md. R. 76); October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B, C amended effective October 23, 2017 (44:21 Md. R. 983)</annotation> </annotations> </chapter> <chapter num="15" heading="Petition for Emergency Evaluation — Payment for Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern payment for specific emergency services, as defined in Health-General Article, §10-628, Annotated Code of Maryland, rendered as a direct consequence of a petition for emergency evaluation.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Consultant” means a physician, licensed by the State, who is not a salaried staff member of the emergency facility and who is authorized by the emergency facility to perform an examination of an emergency evaluee.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Designated emergency facility” means a health care organization currently identified by the Department to perform the functions identified in Health-General Article, §10-624, Annotated Code of Maryland, or this chapter, or both.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency evaluee” means an individual who has been referred to a designated emergency facility on the basis of a petition for emergency evaluation.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency service” means the service rendered as a direct result of the execution of a valid petition.</text> </paragraph> <paragraph num="(6)"> <text>“Emergency vehicle” means:</text> <paragraph num="(a)"> <text>A vehicle operated by a law enforcement officer; or</text> </paragraph> <paragraph num="(b)"> <text>An ambulance regulated according to COMAR 14.22.01 — 14.22.12.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Examination” means a face-to-face diagnostic interview and examination by a consultant physician that includes a medical history, an assessment of mental status, a neurological examination, an assessment of dangerousness, and a written report outlining the consultant physician's findings and conclusions.</text> </paragraph> <paragraph num="(8)"> <text>“Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders.</text> </paragraph> <paragraph num="(9)"> <text>“Petition” means a petition for emergency evaluation that is made by an individual who has reason to believe that the emergency evaluee has a mental disorder and that there is danger of the emergency evaluee's doing bodily harm to the petitioner or another individual.</text> </paragraph> <paragraph num="(10)"> <text>“Provider” means an individual, an association, a partnership, an incorporated or unincorporated group, or a hospital that renders health care service to an emergency evaluee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Payment."> <text>The Department shall pay for emergency service only if:</text> <paragraph num="A."> <text>As determined according to Health-General Article, §16-202, Annotated Code of Maryland, the emergency evaluee cannot pay the charge for the service; and</text> </paragraph> <paragraph num="B."> <text>The emergency evaluee does not have health insurance, including Medicare or Medical Assistance, that covers the allowable payment for the service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Payable Services."> <text>The Department shall limit services payable under this chapter to the following emergency services:</text> <paragraph num="A."> <text>The basic emergency room fee in a designated emergency facility;</text> </paragraph> <paragraph num="B."> <text>The initial examination performed in the emergency room of a designated psychiatric emergency facility by a consultant physician; and</text> </paragraph> <paragraph num="C."> <text>Transportation for the emergency evaluee in an emergency vehicle:</text> <paragraph num="(1)"> <text>From the site where the emergency evaluee is located to the designated emergency facility; and</text> </paragraph> <paragraph num="(2)"> <text>If staff at the emergency facility complete an application and two certificates for involuntary admission according to the provisions of Health-General Article, §§10-615 — 10-616, Annotated Code of Maryland, from the designated emergency facility to the inpatient facility where the emergency evaluee is referred for admission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Billing Procedures."> <paragraph num="A."> <text>The provider shall submit the following documents:</text> <paragraph num="(1)"> <text>A request for payment on a form designated by the Department;</text> </paragraph> <paragraph num="(2)"> <text>A bill that specifies the:</text> <paragraph num="(a)"> <text>Name of the emergency evaluee;</text> </paragraph> <paragraph num="(b)"> <text>Date of service; and</text> </paragraph> <paragraph num="(c)"> <text>Description of service;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A copy of the current petition for emergency evaluation;</text> </paragraph> <paragraph num="(4)"> <text>If the bill is for an examination by a consultant physician, a copy of the consultant physician's evaluation that is signed by the examining consultant physician;</text> </paragraph> <paragraph num="(5)"> <text>If the bill is for transportation of an emergency evaluee from a designated emergency facility to an inpatient facility, copies of both completed certificates for involuntary admission and the application for involuntary admission; and</text> </paragraph> <paragraph num="(6)"> <text>Any other documentation required by the Department to determine that the conditions of this chapter have been met.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall submit the request for payment within 12 months of the date of service.</text> </paragraph> <paragraph num="C."> <text>The Department may refuse a request for payment if the request is not accompanied by properly completed forms and documents required under §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment Rates."> <text>The Department shall pay:</text> <paragraph num="A."> <text>Hospitals, at rates approved by the Health Services Cost Review Commission;</text> </paragraph> <paragraph num="B."> <text>Physicians, the lesser of the:</text> <paragraph num="(1)"> <text>Amount billed; or</text> </paragraph> <paragraph num="(2)"> <text>The Statewide average of prevailing charges for an examination by a physician consultant based on Medicare's 75th percentile as determined according to 42 CFR Sec. 405.504; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Transportation providers, if transportation is by:</text> <paragraph num="(1)"> <text>Ambulance, the lesser of the:</text> <paragraph num="(a)"> <text>Amount billed; or</text> </paragraph> <paragraph num="(b)"> <text>The Statewide average of prevailing charges for an ambulance based on Medicare's 75th percentile; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A law enforcement officer in an emergency vehicle:</text> <paragraph num="(a)"> <text>The cost per mile based on the county's established rates for emergency vehicles; and</text> </paragraph> <paragraph num="(b)"> <text>The cost of the law enforcement officer's hourly wage for the number of hours, not to exceed 4 hours, required to transport the emergency evaluee.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Subrogation by the Department."> <paragraph num="A."> <text>Before billing the Department, the provider shall:</text> <paragraph num="(1)"> <text>Take all reasonable steps to collect the charge from the emergency evaluee and, if applicable, from insurers, including Medicare and Medical Assistance; or</text> </paragraph> <paragraph num="(2)"> <text>Make and document a determination of the evaluee's inability to pay, according to the provisions of Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A provider:</text> <paragraph num="(1)"> <text>Shall accept as payment in full the maximum payment amount allowable under Medicare for services rendered to eligible participants; and</text> </paragraph> <paragraph num="(2)"> <text>May not bill the Department for any amount in excess of that allowable under §B(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a provider receives payment from both the Department and another source, within 30 calendar days of receipt of payment by the other source, the provider shall refund to the Department the amount in excess of the maximum payment allowable under the provisions of §B of this regulation that was paid by the Department.</text> </paragraph> <paragraph num="D."> <text>The provider shall immediately reimburse the Department for any overpayment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Patients' Rights."> <paragraph num="A."> <text>Access to Care. Providers of emergency services shall give an emergency evaluee equal access to treatment and services that are available or medically indicated, regardless of diagnosis, handicap status, race, age, sex, national origin, religious or political opinions or affiliations, or sources of payment for care.</text> </paragraph> <paragraph num="B."> <text>Providers of emergency services shall recognize and respect an emergency evaluee's dignity in the provision of care and treatment.</text> </paragraph> <paragraph num="C."> <text>Confidentiality.</text> <paragraph num="(1)"> <text>The emergency evaluee's medical record is governed by the provisions of confidentiality as set forth in Health-General Article, Title 4, Subtitle 3, and §19-308.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The right of confidentiality does not preclude routine audit or payment processes.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-628, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 9, 1994 (21:9 Md. R. 751)</annotation> </annotations> </chapter> <chapter num="16" heading="Community Mental Health Programs — Application, Approval, and Disciplinary Processes"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter outlines the process for application for, denial of, and disciplinary action on, the approval for a program to be eligible to receive State or federal funds for providing community mental health services.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to programs approved under COMAR 10.21.07 Therapeutic Group Homes or Federally Qualified Health Centers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings indicated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval Requirements."> <text>To be eligible for approval under this chapter, a program shall:</text> <paragraph num="A."> <text>Meet the requirements of:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.21.17;</text> </paragraph> <paragraph num="(3)"> <text>The chapter under this subtitle that outlines the requirements for the specific program; and</text> </paragraph> <paragraph num="(4)"> <text>Medical Assistance regulations, including, but not limited to COMAR 10.09.36, 10.09.59. and 10.09.70; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Demonstrate compliance with:</text> <paragraph num="(1)"> <text>Relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; and</text> </paragraph> <paragraph num="(2)"> <text>The satisfactory fire, safety, and health inspection reports of the site that are required by the local jurisdiction, if a program provides services at a site whose primary function is the delivery of mental health services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Process."> <paragraph num="A."> <text>Consultation. Before submitting an application, an applicant for approval of a program may request assistance from the Department's designated approval unit or the appropriate core service agency (CSA) director regarding the proper compilation of application materials and completion of the application.</text> </paragraph> <paragraph num="B."> <text>Lead CSA Determination. For programs providing services in multiple jurisdictions, the Administration, in collaboration with the appropriate CSAs, shall determine the lead CSA.</text> </paragraph> <paragraph num="C."> <text>Application. An applicant for approval of a program shall:</text> <paragraph num="(1)"> <text>Submit an application to the Department’s designated approval unit;</text> </paragraph> <paragraph num="(2)"> <text>Submit the application on the written or electronic form approved by the Department, with all questions answered and all required documents attached;</text> </paragraph> <paragraph num="(3)"> <text>Include in the application, at a minimum, the following information:</text> <paragraph num="(a)"> <text>Documentation of the applicant's program service plan, as outlined in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>A written business plan that clearly demonstrates the program's ability to provide services in accordance with applicable Maryland regulations and Medicaid and Medicare funding requirements;</text> </paragraph> <paragraph num="(c)"> <text>Information to demonstrate the program's financial viability, including, but not limited to:</text> <paragraph num="(i)"> <text>Salary structure;</text> </paragraph> <paragraph num="(ii)"> <text>Client mix;</text> </paragraph> <paragraph num="(iii)"> <text>Anticipated administrative expenses;</text> </paragraph> <paragraph num="(iv)"> <text>Necessary cash reserves to maintain the program during the start-up phase and a financial crisis;</text> </paragraph> <paragraph num="(v)"> <text>Identification of the individual responsible for providing the required financial information; and</text> </paragraph> <paragraph num="(vi)"> <text>Other information deemed necessary by the Department;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A summary of the program's demonstrated experience in the field of mental health;</text> </paragraph> <paragraph num="(e)"> <text>Prior licensing reports issued within the previous 10 years from any in-State or out-of-State entities associated with the program, including deficiency reports and compliance records from which the Department may make reasoned decisions about the qualifications of the program;</text> </paragraph> <paragraph num="(f)"> <text>Disclosure of:</text> <paragraph num="(i)"> <text>Any license or approval revocation within the previous 10 years by the Department or other licensing agency;</text> </paragraph> <paragraph num="(ii)"> <text>Whether the program, or corporation or entity associated with the program, has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and</text> </paragraph> <paragraph num="(iii)"> <text>Any corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action within the previous 10 years;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A written quality assurance plan that addresses how the organization will ensure the health and safety of the individuals served by the program and the quality of services provided to individuals by the program; and</text> </paragraph> <paragraph num="(h)"> <text>For 26 U.S.C. §501(c)(3) organizations, a statement of how the organization intends to satisfy its charitable mission; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Forward a copy of the:</text> <paragraph num="(a)"> <text>Completed application to the:</text> <paragraph num="(i)"> <text>CSA of the jurisdiction where the program services are to be delivered; or</text> </paragraph> <paragraph num="(ii)"> <text>For programs providing services in multiple jurisdictions, lead CSA identified under §B of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Application cover letter to the Administration and all CSAs of the jurisdictions where the program plans to deliver services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Action by the CSA or Lead CSA. The CSA, or lead CSA identified under §B of this regulation, shall submit to the Department's designated approval unit:</text> <paragraph num="(1)"> <text>Verification that:</text> <paragraph num="(a)"> <text>The program agrees to collaborate with all CSAs where the program proposes to provide services, according to the provisions of COMAR 10.21.17.06; and</text> </paragraph> <paragraph num="(b)"> <text>The financial information submitted under §C of this regulation appears to demonstrate potential financial viability of the program; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comments, if any, on the content of the application.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Application Modification.</text> <paragraph num="(1)"> <text>A program that proposes to change its program sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department's designated approval unit.</text> </paragraph> <paragraph num="(2)"> <text>If the Department's designated approval unit approves the application modification, the existing program approval shall extend to the additional site, as applicable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Program Service Plan (PSP)."> <text>On the forms approved by the Administration as part of the application required under Regulation .04C of this chapter or COMAR 10.21.04.05B, a program shall submit a PSP that includes a description of:</text> <paragraph num="A."> <text>The range of services that the program will provide;</text> </paragraph> <paragraph num="B."> <text>The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve;</text> </paragraph> <paragraph num="C."> <text>Program sites and hours of operation, and the method to ensure that services are accessible to the individuals served;</text> </paragraph> <paragraph num="D."> <text>The goals, objectives, and expected outcomes of the program;</text> </paragraph> <paragraph num="E."> <text>The composition of the program's governing body, board of directors, or advisory committee, whichever applies, as outlined in COMAR 10.21.17.05A;</text> </paragraph> <paragraph num="F."> <text>The jurisdictions where services will be provided and the number of services to be provided in each jurisdiction; and</text> </paragraph> <paragraph num="G."> <text>The jurisdiction where most of the program's services will be rendered.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluation of Application."> <paragraph num="A."> <text>The Department's designated approval unit shall evaluate the application to determine whether the applicant adequately documents that the:</text> <paragraph num="(1)"> <text>Proposed program has met all approval requirements;</text> </paragraph> <paragraph num="(2)"> <text>Applicant has reviewed and is knowledgeable regarding all applicable regulations; and</text> </paragraph> <paragraph num="(3)"> <text>Program will be financially viable.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before making a determination under §A of this regulation, the Department's designated approval unit may:</text> <paragraph num="(1)"> <text>Request clarification of application materials; and</text> </paragraph> <paragraph num="(2)"> <text>Consult with the CSA director, or lead CSA director, and the Administration.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before determining that a program is eligible for approval under this or any other chapter of the Administration's regulations, the Department shall conduct an on-site investigation of the program and meet with the applicant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Temporary Approval."> <paragraph num="A."> <text>If the Department's designated approval unit determines that the program meets all approval requirements, the Secretary shall:</text> <paragraph num="(1)"> <text>Issue temporary approval according to the provisions of §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Forward copies of the approval to the:</text> <paragraph num="(a)"> <text>Appropriate CSA;</text> </paragraph> <paragraph num="(b)"> <text>Administration;</text> </paragraph> <paragraph num="(c)"> <text>ASO;</text> </paragraph> <paragraph num="(d)"> <text>Medical Assistance Program; and</text> </paragraph> <paragraph num="(e)"> <text>The program's chief executive officer (CEO) and president of the advisory committee or governing body, whichever applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Duration of Temporary Approval.</text> <paragraph num="(1)"> <text>The temporary approval is valid for a period of not more than 6 months unless:</text> <paragraph num="(a)"> <text>Before the end of 6 months, the program requests an extension due to a delay in beginning operations; and</text> </paragraph> <paragraph num="(b)"> <text>Upon the recommendation of the Department's designated approval unit, the Secretary grants an extension of not more than 6 months.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a program is granted an extension of temporary approval under §B(1)(b) of this regulation, and the program fails to begin operation during the effective date of the extension, the program's approval automatically ceases.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Denial of Temporary Approval.</text> <paragraph num="(1)"> <text>The Department may deny temporary approval to an applicant if the Department's designated approval unit determines that the application does not meet all approval requirements.</text> </paragraph> <paragraph num="(2)"> <text>The Department may deny a license or approval to:</text> <paragraph num="(a)"> <text>Any corporation or entity that has had a license or approval revoked by the Department or other licensing agency, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and</text> </paragraph> <paragraph num="(b)"> <text>Any corporation or entity that has a corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Secretary may, according to the provisions of Regulation .12A of this chapter, issue an initial notice of proposed denial of temporary approval.</text> </paragraph> <paragraph num="(4)"> <text>If the Secretary takes the action in §C(1) or (2) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulations .12A and .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before the expiration of a temporary approval period:</text> <paragraph num="(1)"> <text>The Department's designated approval unit shall conduct an on-site review to determine approval status outlined in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Following completion of the on-site review required under §D(1) of this regulation, the Secretary shall grant or propose to revoke approval according to the provisions of Regulation .08 or .12 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Approval of a Program."> <paragraph num="A."> <text>Approval Without Conditions.</text> <paragraph num="(1)"> <text>The Secretary shall grant approval without conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program complies with the requirements for approval.</text> </paragraph> <paragraph num="(2)"> <text>Unless the program has been granted deemed status under Regulation .10 of this chapter, within not more than 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program.</text> </paragraph> <paragraph num="(3)"> <text>Based on the review conducted under §A(2) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Approval with Conditions.</text> <paragraph num="(1)"> <text>The Secretary may grant approval with conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program:</text> <paragraph num="(a)"> <text>Is deficient in one or more of the requirements under this chapter, COMAR 10.21.17, or the chapter under the subtitle for the specific program;</text> </paragraph> <paragraph num="(b)"> <text>Has no deficiencies that constitute a threat to health, safety, or welfare of the individuals served;</text> </paragraph> <paragraph num="(c)"> <text>Has documented that the program will collaborate with the CSA, as required under COMAR 10.21.17.06; and</text> </paragraph> <paragraph num="(d)"> <text>Has submitted an acceptable program improvement plan within the time frame established under §B(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Secretary grants a program an approval with conditions under §B(1) of this regulation, the Secretary shall notify the program that the Department's designated approval unit may conduct a focused review under the provisions of §B(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Program Improvement Plan (PIP).</text> <paragraph num="(a)"> <text>Within 10 working days of receipt of the list of deficiencies cited during the on-site review, the program director shall:</text> <paragraph num="(i)"> <text>Submit a proposed PIP that addresses the identified deficiencies to the CSA or lead CSA; and</text> </paragraph> <paragraph num="(ii)"> <text>Collaborate with the CSA or lead CSA to finalize the PIP.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Within 30 calendar days of receipt of the list of deficiencies cited during the on-site review, the program director shall submit:</text> <paragraph num="(i)"> <text>The PIP to the Department's designated approval unit; and</text> </paragraph> <paragraph num="(ii)"> <text>Documentation of the collaboration with the CSA or lead CSA.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Unless an extension has been granted by the Department's designated approval unit, if a program fails to submit a completed PIP within the time frames established in §B(3)(a) and (b) of this regulation, the Secretary may pursue disciplinary action under Regulation .12C of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Focused Review.</text> <paragraph num="(a)"> <text>For programs that have been granted approval with conditions, the Department's designated approval unit may conduct a focused review to:</text> <paragraph num="(i)"> <text>Reevaluate the deficiencies cited during the on-site review conducted under §B(1) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Review the program's progress on the PIP.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Based on the focused review conducted under §B(4)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Regular Program Review.</text> <paragraph num="(a)"> <text>Within 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program.</text> </paragraph> <paragraph num="(b)"> <text>Based on the review conducted under §B(5)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Certificate of Approval.</text> <paragraph num="(1)"> <text>If the Department's designated approval unit determines that a program is eligible for approval, the Secretary shall issue a certificate of approval to the program director that specifies the:</text> <paragraph num="(a)"> <text>Chapter under which the program has been approved;</text> </paragraph> <paragraph num="(b)"> <text>Type of approval; and</text> </paragraph> <paragraph num="(c)"> <text>Beginning and expiration dates of the approval period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary shall notify the Administration, the CSA of the jurisdiction where the program provides services, the Medical Assistance Program, and the ASO of the program's approval.</text> </paragraph> <paragraph num="(3)"> <text>The program director shall ensure that the certificate of approval is available during the regular hours of operation.</text> </paragraph> <paragraph num="(4)"> <text>Sale or Transfer of Certificate of Approval.</text> <paragraph num="(a)"> <text>The Secretary's certificate of approval of a program, issued according to the provisions of §C(1) of this regulation, is valid only for the program to which the Secretary's certificate of approval is issued.</text> </paragraph> <paragraph num="(b)"> <text>A program may not sell, assign, or transfer a certificate of approval to another program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Extension of Approval Status. The Secretary shall maintain the program's existing approval status if, before the expiration of approval period, the:</text> <paragraph num="(1)"> <text>Department's designated approval unit does not complete an on-site review; or</text> </paragraph> <paragraph num="(2)"> <text>Department does not reach a decision regarding approval.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Waivers and Variances."> <paragraph num="A."> <text>Waivers. The Secretary may not waive the requirements of any regulation adopted under:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.21.17; or</text> </paragraph> <paragraph num="(3)"> <text>The chapter under this subtitle that outlines the requirements for a specific program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Variances.</text> <paragraph num="(1)"> <text>A program that is approved under Regulation .08 of this chapter may apply for a variance.</text> </paragraph> <paragraph num="(2)"> <text>When a program is approved under Regulation .08 of this chapter, the Secretary may grant a variance for a regulation if the Secretary:</text> <paragraph num="(a)"> <text>Receives a written request from a program on the form required by the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Secretary may not grant a variance that would endanger the health or safety of the individuals served.</text> </paragraph> <paragraph num="(4)"> <text>The Secretary may grant a variance that:</text> <paragraph num="(a)"> <text>Remains in effect for as long as the program continues to comply with the conditions under which the variance is granted; or</text> </paragraph> <paragraph num="(b)"> <text>Is time limited.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Secretary shall:</text> <paragraph num="(a)"> <text>Issue a written decision, including the reason or reasons for granting or not granting the variance;</text> </paragraph> <paragraph num="(b)"> <text>Send the decision to the:</text> <paragraph num="(i)"> <text>Program director;</text> </paragraph> <paragraph num="(ii)"> <text>CSA; and</text> </paragraph> <paragraph num="(iii)"> <text>Department's designated approval unit; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Enter the decision in the records of the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Deemed Status."> <paragraph num="A."> <text>Initial Request for Deemed Status. If a program is approved under Regulation .08 of this chapter and is accredited under relevant behavioral health care standards of the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) or the Rehabilitation Accreditation Commission (CARF), the program director may request that the Secretary grant the program deemed status by submitting a written request to the Administration and the CSA at least 90 days before the expiration of the program's current approval status that includes the:</text> <paragraph num="(1)"> <text>Application for deemed status;</text> </paragraph> <paragraph num="(2)"> <text>Accreditation body's full report, including the program's status and any conditions placed on the program;</text> </paragraph> <paragraph num="(3)"> <text>Most recent report by the Department's designated approval unit; and</text> </paragraph> <paragraph num="(4)"> <text>Program improvement plans, if any, required by the accreditation body or the Department's designated approval unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Request for Renewal of Deemed Status. The program may request that the Secretary renew the program's deemed status by submitting a written request to the Administration at least 60 calendar days before the expiration of the program's current deemed status that includes the:</text> <paragraph num="(1)"> <text>Application for deemed status renewal;</text> </paragraph> <paragraph num="(2)"> <text>Most recent accreditation body's full report, including the program's status and any conditions placed on the program;</text> </paragraph> <paragraph num="(3)"> <text>Program improvement plan, if any, required by the accreditation body; and</text> </paragraph> <paragraph num="(4)"> <text>Documentation of verification from the CSA or lead CSA, of program compliance with the conditions, if any, outlined under §D(1)(b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Evaluation of Request for Initial Deemed Status or Renewal of Deemed Status. Within 60 calendar days of receipt of the request under §A or B of this regulation:</text> <paragraph num="(1)"> <text>The Administration, in consultation with the CSA or lead CSA, and the Department's designated approval unit:</text> <paragraph num="(a)"> <text>Shall evaluate the request for deemed status;</text> </paragraph> <paragraph num="(b)"> <text>May meet with the program director; and</text> </paragraph> <paragraph num="(c)"> <text>May arrange for an on-site evaluation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Director shall recommend to the Secretary a decision regarding deemed status, based on:</text> <paragraph num="(a)"> <text>Comparison of the standards used by the accreditation body with the chapter under this subtitle that outlines the requirements for the specific program; and</text> </paragraph> <paragraph num="(b)"> <text>The results of an on-site evaluation, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Decision Regarding Deemed Status. Based on the evaluation of the request for deemed status conducted under §C of this regulation, the Secretary shall:</text> <paragraph num="(1)"> <text>Decide whether to:</text> <paragraph num="(a)"> <text>Approve deemed status;</text> </paragraph> <paragraph num="(b)"> <text>Approve deemed status with conditions, which may include evaluation by the Department's designated approval unit; or</text> </paragraph> <paragraph num="(c)"> <text>Propose to deny approval of deemed status; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Send notice of the decision to the:</text> <paragraph num="(a)"> <text>Department's designated approval unit;</text> </paragraph> <paragraph num="(b)"> <text>Program director;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>CSA or lead CSA.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Denial of Deemed Status.</text> <paragraph num="(1)"> <text>If the Secretary proposes to deny approval of deemed status, the Secretary shall give written notice of the proposed denial to the:</text> <paragraph num="(a)"> <text>Department's designated approval unit;</text> </paragraph> <paragraph num="(b)"> <text>Program director;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>CSA or lead CSA.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the notice under §E(1) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date that the Secretary proposes to deny approval of deemed status; and</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed denial of deemed status.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice under §E(2) of this regulation, the program director may:</text> <paragraph num="(a)"> <text>Withdraw the request for deemed status; and</text> </paragraph> <paragraph num="(b)"> <text>Request an on-site review for approval by the Department's designated approval unit.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the program director does not take the action under §E(3) of this regulation and if, after notice and opportunity to be heard, the Secretary denies approval of deemed status, the Director shall notify the program director that, unless the program elects not to seek approval, the Department's designated approval unit shall conduct an on-site review for the purpose of granting or denying approval under Regulation .08 or .12 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Program Inspection and Investigation by the Department."> <text>The Department, its designees, the Administration, the Administration's ASO, CSA, and federal funding agents may:</text> <paragraph num="A."> <text>Make announced and unannounced visits to a program; and</text> </paragraph> <paragraph num="B."> <text>Inspect and copy all records, including, but not limited to financial, treatment, and service records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Denial, Emergency Suspension of Approval, and Disciplinary Action."> <paragraph num="A."> <text>Denial of Approval.</text> <paragraph num="(1)"> <text>If the Secretary proposes to deny approval to an applicant under the provisions of this chapter, the Secretary shall give written notice of the proposed denial to the:</text> <paragraph num="(a)"> <text>Applicant;</text> </paragraph> <paragraph num="(b)"> <text>Program's CEO and president of the advisory committee or governing body, whichever applies;</text> </paragraph> <paragraph num="(c)"> <text>Administration;</text> </paragraph> <paragraph num="(d)"> <text>CSA or lead CSA;</text> </paragraph> <paragraph num="(e)"> <text>ASO; and</text> </paragraph> <paragraph num="(f)"> <text>Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the notice under §A(1) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date on which the Secretary proposes to deny approval;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed denial of approval;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed denial is based; and</text> </paragraph> <paragraph num="(d)"> <text>Notification:</text> <paragraph num="(i)"> <text>That before the denial of approval, the program may request a hearing under the provisions of Regulation .16 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>When feasible, of a case resolution conference.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Suspension of Approval.</text> <paragraph num="(1)"> <text>Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a program, the Secretary may order the immediate suspension of the approval of the program and the cessation of operation.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary takes the action under §B(1) of this regulation, the Secretary shall promptly give written notice of the proposed emergency suspension to the:</text> <paragraph num="(a)"> <text>Program director;</text> </paragraph> <paragraph num="(b)"> <text>President of the program's advisory committee, board of directors, or governing body, whichever is applicable;</text> </paragraph> <paragraph num="(c)"> <text>Administration;</text> </paragraph> <paragraph num="(d)"> <text>CSA or lead CSA;</text> </paragraph> <paragraph num="(e)"> <text>Department's designated approval unit;</text> </paragraph> <paragraph num="(f)"> <text>ASO; and</text> </paragraph> <paragraph num="(g)"> <text>Medical Assistance Program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the notice under §B(2) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The proposed effective date of the emergency suspension;</text> </paragraph> <paragraph num="(b)"> <text>When feasible, the date of a pre-deprivation hearing and a case resolution conference prior to the Department's final action;</text> </paragraph> <paragraph num="(c)"> <text>The findings under §B(1) of this regulation and the reasons that support the finding;</text> </paragraph> <paragraph num="(d)"> <text>Notification that:</text> <paragraph num="(i)"> <text>Following the emergency suspension, the program may request a hearing under the provisions of Regulation .16 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Secretary suspends approval, the program director shall immediately:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the suspension;</text> </paragraph> <paragraph num="(b)"> <text>Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program; and</text> </paragraph> <paragraph num="(c)"> <text>Cease operations of the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Disciplinary Action.</text> <paragraph num="(1)"> <text>The Secretary may propose to take any of the following disciplinary actions against a program:</text> <paragraph num="(a)"> <text>Revocation of approval;</text> </paragraph> <paragraph num="(b)"> <text>Suspension of approval;</text> </paragraph> <paragraph num="(c)"> <text>Probation with conditions; or</text> </paragraph> <paragraph num="(d)"> <text>Banning new admissions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may propose to take one of the actions outlined in §C(1) of this regulation if the program:</text> <paragraph num="(a)"> <text>Is out of compliance with the requirements of:</text> <paragraph num="(i)"> <text>This chapter;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.21.17; or</text> </paragraph> <paragraph num="(iii)"> <text>The chapter under this subtitle that outlines the requirements for the specific program;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Fails to maintain financial viability; or</text> </paragraph> <paragraph num="(c)"> <text>Obtains or attempts to obtain approval by fraud, misrepresentation, or the submission of false information to the Secretary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except under §B of this regulation, no less than 45 calendar days in advance of the proposed action taken under this regulation, the Secretary shall send written notice of the proposed action to the:</text> <paragraph num="(a)"> <text>Program director;</text> </paragraph> <paragraph num="(b)"> <text>President of the program's advisory committee, board of directors, or governing body, whichever is applicable;</text> </paragraph> <paragraph num="(c)"> <text>Administration; and</text> </paragraph> <paragraph num="(d)"> <text>CSA or lead CSA.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In the notice under §C(3) of this regulation, the Secretary shall include:</text> <paragraph num="(a)"> <text>The date on which the Secretary proposes to take action, and when feasible, the date of a case resolution conference;</text> </paragraph> <paragraph num="(b)"> <text>The facts that warrant the proposed action;</text> </paragraph> <paragraph num="(c)"> <text>Citation of the regulation or regulations upon which the proposed action is based; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that, before the action, the program has the right to request a hearing under the provisions of Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, after notice and opportunity to be heard, the Secretary takes disciplinary action, the program director shall, within 10 working days:</text> <paragraph num="(a)"> <text>Notify individuals or the guardians of individuals receiving services of the action; and</text> </paragraph> <paragraph num="(b)"> <text>If the program ceases operations:</text> <paragraph num="(i)"> <text>Notify the CSA or lead CSA and the Administration of the cessation; and</text> </paragraph> <paragraph num="(ii)"> <text>Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Program Request for Discontinuation of Operations."> <paragraph num="A."> <text>If a program intends to discontinue operation, the program director shall, no less than 60 calendar days before the program intends to discontinue operation, submit to the Department's approval unit, the Administration, and the lead CSA its written plan for:</text> <paragraph num="(1)"> <text>Cessation of operations, including relevant dates;</text> </paragraph> <paragraph num="(2)"> <text>Transitioning individuals within its program to other mental health services;</text> </paragraph> <paragraph num="(3)"> <text>Storing and protecting all records;</text> </paragraph> <paragraph num="(4)"> <text>Notifying employees, consultants, and consumers of its cessation of operations;</text> </paragraph> <paragraph num="(5)"> <text>If a nonprofit organization, the return of funds to the State, as required;</text> </paragraph> <paragraph num="(6)"> <text>Reimbursement of employees for lost benefits, such as sick leave, vacation, and pension plan transitions; and</text> </paragraph> <paragraph num="(7)"> <text>An audited financial statement, current as of the date of the request to discontinue operations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Within 30 days of receipt of the program's request to discontinue operations, the Department's approval unit shall:</text> <paragraph num="(1)"> <text>Notify the program in writing whether its plan is acceptable; and</text> </paragraph> <paragraph num="(2)"> <text>If the plan is unacceptable, meet with the program and the lead CSA to formulate a plan that protects the health, safety, and welfare of the individuals served by the program and program staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program may not discontinue operations until the Department's approval unit authorizes this discontinuation.</text> </paragraph> <paragraph num="D."> <text>The program shall be responsible for delivering services to the individuals in its program until such time as the Department's approval unit approves the discontinuation.</text> </paragraph> <paragraph num="E."> <text>The program shall surrender its approval to provide services concurrent with the date on which it ceases operation.</text> </paragraph> <paragraph num="F."> <text>At all times, the program shall cooperate with the Administration, the Department's approval unit, and the lead CSA.</text> </paragraph> <paragraph num="G."> <text>Failure to comply with any section of this regulation may result in monetary penalties against the program's surety bond.</text> </paragraph> <paragraph num="H."> <text>If a program that is discontinuing operation does not comply with §§A — F of this regulation, the Secretary may deny approval to any future application that the program, or principals of the program, may submit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Program Request for Discontinuation of Approval."> <paragraph num="A."> <text>If a program wishes to discontinue approval, the program director shall, not less than 60 calendar days before the date the program wishes to discontinue approval:</text> <paragraph num="(1)"> <text>Submit to the Department's designated approval unit a letter requesting discontinuation of approval; and</text> </paragraph> <paragraph num="(2)"> <text>Notify, in writing, the:</text> <paragraph num="(a)"> <text>Individuals or the guardians of individuals receiving services that the program has requested discontinuation of approval, and the effective date of the discontinuation; and</text> </paragraph> <paragraph num="(b)"> <text>CSA or lead CSA, the Administration, Medical Assistance Program, and the ASO of the discontinuation of approval and the effective date of discontinuation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Within 60 calendar days from the receipt of the request for discontinuation of approval, the Secretary shall:</text> <paragraph num="(1)"> <text>Notify, in writing, the program director of the discontinuation of the program's approval and the effective date; and</text> </paragraph> <paragraph num="(2)"> <text>Forward a copy of the discontinuation to the Administration, Medical Assistance Program, CSA, and the ASO.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When a program's decision to discontinue approval results in the discontinuation of services to any individual receiving services, the program director shall cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Initiation of Receivership."> <text>The Secretary may take action to initiate receivership under the provision of Health-General Article, §§19-333 — 19-339, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Procedures for Hearings."> <paragraph num="A."> <text>If the Secretary proposes to deny approval or initiate disciplinary action, the Secretary shall give the program director written notice of the proposed action, according to the provisions outlined in Regulation .12A — C of this chapter.</text> </paragraph> <paragraph num="B."> <text>Within 10 working days of receipt of the notification of the action under §A of this regulation, the program director may file a written request for a hearing with the Office of Administrative Hearings, with copies to the:</text> <paragraph num="(1)"> <text>Administration;</text> </paragraph> <paragraph num="(2)"> <text>CSA or lead CSA; and</text> </paragraph> <paragraph num="(3)"> <text>Director of the Department's designated approval unit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the program director does not file a request for hearing that is postmarked within 10 working days of receipt of the notification, the program waives the right to request a hearing, and the Secretary may effect the proposed action.</text> </paragraph> <paragraph num="D."> <text>If a timely request for hearing has been received, the Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Notify the Director and the program director of the date, time, and location of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Hold a hearing and render a proposed decision to the Secretary in accordance with COMAR 28.02.01.</text> </paragraph> </paragraph> <paragraph num="E."> <text>After giving parties the opportunity to file exceptions and make oral arguments under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice of the decision to the:</text> <paragraph num="(1)"> <text>Administration;</text> </paragraph> <paragraph num="(2)"> <text>ASO;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate CSA;</text> </paragraph> <paragraph num="(4)"> <text>Medical Assistance Program; and</text> </paragraph> <paragraph num="(5)"> <text>Program director.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Further Appeal. A program may appeal any final decision by the Secretary by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-205, 10-901, and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1995 (21:26 Md. R. 2187)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 5, 1998 (25:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .12 repealed and new Regulations .01 — .16 adopted effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> </annotations> </chapter> <chapter num="17" heading="Community Mental Health Programs — Definitions and Administrative Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter delineates the administrative requirements for a community mental health program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In COMAR 10.21.16 and subsequent community mental health program chapters, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Ability to pay” means the individual's ability to pay for mental health services, as determined according to the provisions of COMAR 10.04.02.</text> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative services organization (ASO)” means the entity with which the Administration may contract to provide the services described in COMAR 10.09.70 for the public mental health system.</text> </paragraph> <paragraph num="(4)"> <text>“Advance directive for mental health services” means a plan made by an individual pursuant to Health-General Article, §5-602.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Aftercare plan” means the plan developed by inpatient facility staff according to the requirements of Health-General Article, §10-809, Annotated Code of Maryland and COMAR 10.21.05.</text> </paragraph> <paragraph num="(6)"> <text>“Case coordination” means the process by which mental health and related support services to an individual are coordinated and monitored.</text> </paragraph> <paragraph num="(7)"> <text>“Case resolution conference (CRC)” means an informal proceeding before an evidentiary hearing to determine if there are grounds for settlement of a contested case.</text> </paragraph> <paragraph num="(8)"> <text>“Community support specialist” means the case manager as defined in COMAR 10.09.45.</text> </paragraph> <paragraph num="(9)"> <text>“Contact note” means an entry that is made in an individual's medical record by a program staff member and that describes face-to-face, written, or telephone contact with or regarding the individual.</text> </paragraph> <paragraph num="(10)"> <text>“Core service agency (CSA)” means the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, to carry out the duties set forth therein.</text> </paragraph> <paragraph num="(11)"> <text>“Credentialing” means the collection, verification, and assessment of information regarding four critical parameters:</text> <paragraph num="(a)"> <text>Current licensure;</text> </paragraph> <paragraph num="(b)"> <text>Relevant training;</text> </paragraph> <paragraph num="(c)"> <text>Current competence; and</text> </paragraph> <paragraph num="(d)"> <text>The ability to perform clinical responsibilities.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Crisis intervention” means the therapeutic response that provides immediate care or referral for an individual with urgent mental health need.</text> </paragraph> <paragraph num="(13)"> <text>“Day treatment program” means a program approved under COMAR 10.21.02 and is also referred to as partial hospitalization or psychiatric day treatment.</text> </paragraph> <paragraph num="(14)"> <text>“Deemed status” means the Secretary's granting of approval under this subtitle to a program, based on the program's accreditation under the relevant behavioral healthcare standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or Rehabilitation Accreditation Commission (CARF).</text> </paragraph> <paragraph num="(15)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(16)"> <text>“Designated emergency facility” means a health care facility identified under Health-General Article, §10-620, Annotated Code of Maryland, to perform the duties under Health-General Article, §10-624, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Director” means the Director of the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(18)"> <text>“Discharge plan” means a brief description of the recommendations for continued treatment.</text> </paragraph> <paragraph num="(19)"> <text>“Discharge summary” means a detailed review of services provided to an individual, including, at a minimum, the items outlined in Regulation .11C of this chapter.</text> </paragraph> <paragraph num="(20)"> <text>“Enhanced support” means short-term, in-home services, in addition to other services to an individual, by a program that is approved by the Administration to provide this service, to support the individual to remain in the community.</text> </paragraph> <paragraph num="(21)"> <text>“Enrolled” means the program's formal acceptance and admission of an individual into the program.</text> </paragraph> <paragraph num="(22)"> <text>“Facility” has the meaning indicated in Health-General Article, §10-102(e), Annotated Code of Maryland, and may also be referred to as a site.</text> </paragraph> <paragraph num="(23)"> <text>“Governing body” means the organizational structure that is responsible for all program operations, including:</text> <paragraph num="(a)"> <text>Establishing policy;</text> </paragraph> <paragraph num="(b)"> <text>Maintaining quality care; and</text> </paragraph> <paragraph num="(c)"> <text>Providing management and planning for the program.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Grievance” means an oral or written complaint filed by or on behalf of an individual regarding the denial of services based on eligibility or medical necessity criteria.</text> </paragraph> <paragraph num="(25)"> <text>“Group home” means a private group home as defined in Health-General Article, §10-514, Annotated Code of Maryland, and licensed under COMAR 10.21.04.</text> </paragraph> <paragraph num="(26)"> <text>“Guardian” means a guardian as defined in Estates and Trusts Article, §13-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“HIPAA” means part of the federal act outlined in 42 U.S.C. §1320D et seq., as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended.</text> </paragraph> <paragraph num="(28)"> <text>“Health officer” means the individual nominated by a county and appointed by the Secretary under the provision of Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Health promotion and training” means activities to increase an individual's awareness of physical and mental health status and of the resources required to help promote good physical and mental health.</text> </paragraph> <paragraph num="(30)"> <text>“Independent living skills training” means activities to promote, maintain, or restore an individual's ability to perform essential activities of daily life.</text> </paragraph> <paragraph num="(31)"> <text>“Individual” means:</text> <paragraph num="(a)"> <text>An adult;</text> </paragraph> <paragraph num="(b)"> <text>A person authorized to consent to health care for an adult;</text> </paragraph> <paragraph num="(c)"> <text>A minor;</text> </paragraph> <paragraph num="(d)"> <text>A minor who is 16 years old or older, if the medical care concerns treatment to which the minor has the right to consent, and if the minor has consented to treatment;</text> </paragraph> <paragraph num="(e)"> <text>A parent;</text> </paragraph> <paragraph num="(f)"> <text>A guardian;</text> </paragraph> <paragraph num="(g)"> <text>The attorney of the minor;</text> </paragraph> <paragraph num="(h)"> <text>The custodian of the minor; or</text> </paragraph> <paragraph num="(i)"> <text>A representative of the minor designated by a court who can legally consent to treatment consistent with the authority granted.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Individual rehabilitation plan (IRP)” means the plan prepared according to the requirements outlined in the chapter or chapters under this subtitle that delineate the requirements for the specific rehabilitation program.</text> </paragraph> <paragraph num="(33)"> <text>Individual Treatment and Rehabilitation Plan (ITRP).</text> <paragraph num="(a)"> <text>“ITRP” means the plan prepared according to the requirements outlined in the chapter or chapters under this subtitle that delineate the requirements for the specific program.</text> </paragraph> <paragraph num="(b)"> <text>“ITRP” may substitute for a separate ITP and IRP.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Individual Treatment Plan (ITP)” means the plan prepared according to the requirements outlined in the chapters under this subtitle that delineate the requirements for the specific program.</text> </paragraph> <paragraph num="(35)"> <text>“Inpatient facility” means an inpatient institution that provides evaluation, treatment, and 24-hour residential care for individuals who have mental disorders.</text> </paragraph> <paragraph num="(36)"> <text>“Lead CSA” means, for programs that provide services in multiple jurisdictions, the CSA identified by the Administration in collaboration with the appropriate CSAs to represent all involved jurisdictions.</text> </paragraph> <paragraph num="(37)"> <text>“Managed intervention plan (MIP)”:</text> <paragraph num="(a)"> <text>Means the plan that is developed, when appropriate, that details the strategies to be implemented in times of crisis to provide for a revised plan of services and supports to maintain the individual in a residential rehabilitation program residence, to prevent the unplanned discontinuation of services, or to prevent an inpatient admission; and</text> </paragraph> <paragraph num="(b)"> <text>May be incorporated into the individual rehabilitation plan (IRP) or individual treatment and rehabilitation plan (ITRP).</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Maryland Medical Records Act” means the act outlined in Health-General Article, §4-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(39)"> <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text> </paragraph> <paragraph num="(40)"> <text>“Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., as amended.</text> </paragraph> <paragraph num="(41)"> <text>Medication Monitoring.</text> <paragraph num="(a)"> <text>“Medication monitoring” means:</text> <paragraph num="(i)"> <text>Providing face-to-face assistance to an individual to achieve compliance with treatment with all prescribed psychiatric or somatic medications; and</text> </paragraph> <paragraph num="(ii)"> <text>As needed, reviewing the individual's existing medication regimen with the appropriate physician.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Medication monitoring” does not mean:</text> <paragraph num="(i)"> <text>Prescribing medication;</text> </paragraph> <paragraph num="(ii)"> <text>Measuring or pouring medicine;</text> </paragraph> <paragraph num="(iii)"> <text>Preparation of a syringe for injection; or</text> </paragraph> <paragraph num="(iv)"> <text>Administration of medication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(42)"> <text>“Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(43)"> <text>“Mental health program (program)” means a community-based program that is approved by the Department under this subtitle to be eligible to receive State or federal funds, or both.</text> </paragraph> <paragraph num="(44)"> <text>“Mental health vocational program (MHVP)” means a program approved under COMAR 10.21.28.</text> </paragraph> <paragraph num="(45)"> <text>“Minor” means an individual who is younger than 18 years old.</text> </paragraph> <paragraph num="(46)"> <text>“Mobile treatment services (MTS) program” means a program approved under COMAR 10.21.19.</text> </paragraph> <paragraph num="(47)"> <text>“Nurse” means an individual who is licensed and legally authorized to practice as a nurse:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(48)"> <text>“Occupational therapist” means an individual who is licensed and legally authorized to practice as an occupational therapist:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“On-call” means the availability of designated program staff 24 hours per day, 7 days per week.</text> </paragraph> <paragraph num="(50)"> <text>“Outpatient mental health center (OMHC)” means a program approved under COMAR 10.21.20.</text> </paragraph> <paragraph num="(51)"> <text>“Physician” means an individual who is licensed and legally authorized to practice medicine:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the individual, whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services and includes PCPs covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.09.67.</text> </paragraph> <paragraph num="(53)"> <text>“Primary caretaker” means the minor's custodial parent or parents or the adult with whom the minor currently resides.</text> </paragraph> <paragraph num="(54)"> <text>“Privileging” means the process by which a program determines that staff members are qualified to perform assigned duties.</text> </paragraph> <paragraph num="(55)"> <text>“Professional counselor” means an individual who is certified or licensed and legally authorized to practice as a professional counselor:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(56)"> <text>“Program director” means the individual who is responsible for the daily operations of a program, as outlined in the chapter under this subtitle that delineates the requirements for a specific program.</text> </paragraph> <paragraph num="(57)"> <text>“Program improvement plan (PIP)” means a written statement from a program that documents the program's methods and time frames for correcting deficiencies cited by the Department's designated approval unit.</text> </paragraph> <paragraph num="(58)"> <text>“Progress summary note” means an entry by an individual's program coordinator in the individual's medical record that summarizes the individual's progress toward goals delineated in the individual's ITP, IRP, or ITRP.</text> </paragraph> <paragraph num="(59)"> <text>“Provisional diagnosis” means the diagnosis given as a result of an initial assessment of the symptoms at the first encounter with an individual that lasts only until the correct nature of the illness has been clarified by further clinical examination.</text> </paragraph> <paragraph num="(60)"> <text>“Psychiatric rehabilitation program (PRP)” means a program approved under COMAR 10.21.21 for adults, and COMAR 10.21.29 for minors, or both.</text> </paragraph> <paragraph num="(61)"> <text>“Psychiatrist” means a physician who:</text> <paragraph num="(a)"> <text>Is certified in psychiatry by the American Board of Psychiatry and Neurology; or</text> </paragraph> <paragraph num="(b)"> <text>Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.</text> </paragraph> </paragraph> <paragraph num="(62)"> <text>“Psychologist” means an individual who is licensed and legally authorized to practice as a psychologist:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Psychologist Associate” means an individual approved by the Board of Examiners of Psychologists for exemption to perform psychological services pursuant to Health Occupations Article, §18-301(b)(3), Annotated Code of Maryland, and COMAR 10.36.07.</text> </paragraph> <paragraph num="(64)"> <text>Public Mental Health System (PMHS).</text> <paragraph num="(a)"> <text>“Public mental health system” means the system for the delivery of mental health treatment and supports to individuals who meet medical necessity criteria and financial eligibility as established by the Maryland Department of Health Administration.</text> </paragraph> <paragraph num="(b)"> <text>“Public mental health system” includes the specialty mental health system described in COMAR 10.09.70.</text> </paragraph> </paragraph> <paragraph num="(65)"> <text>“Quality management (QM)” means the process by which a program maintains and improves the quality of services.</text> </paragraph> <paragraph num="(66)"> <text>“Referral” means a contact made with a program by an individual, or on behalf of an individual, for mental health services.</text> </paragraph> <paragraph num="(67)"> <text>“Rehabilitation coordinator” means the program staff person who is responsible for coordinating and providing rehabilitation services to an individual.</text> </paragraph> <paragraph num="(68)"> <text>“Residence” means a housing unit leased or owned by an approved residential rehabilitation program (RRP).</text> </paragraph> <paragraph num="(69)"> <text>“Residential checklist” means the form issued by the Department for the purpose of recording information gathered during the inspection of rehabilitation residences.</text> </paragraph> <paragraph num="(70)"> <text>“Residential crisis services (RCS)” means services provided by a program approved under COMAR 10.21.26.</text> </paragraph> <paragraph num="(71)"> <text>“Residential rehabilitation program (RRP)” means a program that is approved under COMAR 10.21.22.</text> </paragraph> <paragraph num="(72)"> <text>“Residential specialist” means the individual designated by the Department or the CSA to inspect, monitor, and determine the approval status of a residence.</text> </paragraph> <paragraph num="(73)"> <text>“Respite care services” means services provided by a program approved under COMAR 10.21.27.</text> </paragraph> <paragraph num="(74)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(75)"> <text>“Serious emotional disturbance” means a condition that is:</text> <paragraph num="(a)"> <text>Manifest in an individual younger than 18 years old;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosed according to a current diagnostic classification system that is recognized by the Secretary, excluding the following, unless they co-exist with a diagnosable psychiatric disorder:</text> <paragraph num="(i)"> <text>Developmental disorders;</text> </paragraph> <paragraph num="(ii)"> <text>Substance abuse; and</text> </paragraph> <paragraph num="(iii)"> <text>Disorder classified under the “V” code; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Characterized by a functional impairment that substantially interferes with or limits the minor's functioning in the family, school, or community.</text> </paragraph> </paragraph> <paragraph num="(76)"> <text>“Serious mental illness” means a mental disorder that is:</text> <paragraph num="(a)"> <text>Manifest in an individual 18 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosed, according to a current diagnostic classification system that is recognized by the Secretary as:</text> <paragraph num="(i)"> <text>Schizophrenic disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Major affective disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Other psychotic disorder; or</text> </paragraph> <paragraph num="(iv)"> <text>Borderline or schizotypal personality disorder, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Characterized by impaired functioning on a continuing or intermittent basis, for at least 2 years, and includes at least three of the following:</text> <paragraph num="(i)"> <text>Inability to maintain independent employment;</text> </paragraph> <paragraph num="(ii)"> <text>Social behavior that results in interventions by the mental health system;</text> </paragraph> <paragraph num="(iii)"> <text>Inability, due to cognitive disorganization, to procure financial assistance to support living in the community;</text> </paragraph> <paragraph num="(iv)"> <text>Severe inability to establish or maintain a personal support system; or</text> </paragraph> <paragraph num="(v)"> <text>Need for assistance with basic living skills.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(77)"> <text>“Social skills training” means activities to diminish tendencies toward isolation and withdrawal by assisting individuals to acquire, maintain, or develop communication and other interpersonal skills.</text> </paragraph> <paragraph num="(78)"> <text>“Social worker” means an individual who is licensed and legally authorized to practice as a social worker:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(79)"> <text>“Supported housing” means activities to enable an individual to maintain housing of the individual's choice.</text> </paragraph> <paragraph num="(80)"> <text>“Therapeutic group home (TGH)” means a program that is licensed under COMAR 10.21.04, 10.21.07, and COMAR 14.31.05, 14.31.06, and 14.31.07.</text> </paragraph> <paragraph num="(81)"> <text>“Therapeutic milieu” means an environment that is clinically structured to provide mental health treatment in a place other than the individual's residence.</text> </paragraph> <paragraph num="(82)"> <text>“Therapeutic nursery program (TNP)” means a program approved under COMAR 10.21.18.</text> </paragraph> <paragraph num="(83)"> <text>“Treatment coordinator” means the licensed mental health professional who is responsible for coordinating and providing mental health services to an individual.</text> </paragraph> <paragraph num="(84)"> <text>“Working day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authorization and Payment."> <paragraph num="A."> <text>Authorization for Services.</text> <paragraph num="(1)"> <text>The program shall comply with the provisions of this regulation when the program provides services to:</text> <paragraph num="(a)"> <text>A Medicaid recipient; or</text> </paragraph> <paragraph num="(b)"> <text>An individual for whom, because of the severity of the mental illness and, based on the Administration's determination of the individual's ability to pay, the cost of care is subsidized, wholly or in part, through the public mental health system.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before rendering services to an individual, a provider shall notify the Administration's administrative services organization (ASO), or for those services approved by the CSA, the CSA of the jurisdiction where the individual resides, as appropriate, and receive preauthorization for services, according to the provisions of COMAR 10.09.70.07.</text> </paragraph> <paragraph num="(3)"> <text>When the Administration's ASO contacts a program directly to refer an individual, and the individual does not make an initial appointment or does not keep the initial appointment, program staff shall:</text> <paragraph num="(a)"> <text>Attempt to reschedule an initial appointment for the individual; and</text> </paragraph> <paragraph num="(b)"> <text>If that fails, notify the Administration's ASO that the individual has not received services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Preauthorization is not required before a provider renders services in an emergency.</text> </paragraph> <paragraph num="(5)"> <text>If a program discontinues admissions, the program director shall notify the CSA and the Administration's ASO, if appropriate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Payment for Services.</text> <paragraph num="(1)"> <text>Fee Schedule. The Administration shall reimburse an eligible provider for rendering authorized services:</text> <paragraph num="(a)"> <text>In accordance with the State budget;</text> </paragraph> <paragraph num="(b)"> <text>According to the provisions of and at the rates established under COMAR 10.21.25; or</text> </paragraph> <paragraph num="(c)"> <text>Pursuant to grants or contracts funded by the State or the CSAs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an individual is not a Medicaid recipient and, because of the severity of the individual's mental illness and financial need, the cost of the individual's care is subsidized wholly or in part with public funds, the provider shall:</text> <paragraph num="(a)"> <text>Receive payment if the individual meets eligibility criteria established by the Administration;</text> </paragraph> <paragraph num="(b)"> <text>Collect information from an individual to assess the individual's ability to pay, including information regarding any applicable insurance benefits;</text> </paragraph> <paragraph num="(c)"> <text>Assess the individual's ability to pay and determine the required co-payment; and</text> </paragraph> <paragraph num="(d)"> <text>Make collections of the co-payment according to the requirements in Health-General Article, §§16-201 — 16-204, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medicare Recipients.</text> <paragraph num="(a)"> <text>If a provider renders services to individuals who are Medicare recipients, the provider shall comply with all federal Medicare requirements.</text> </paragraph> <paragraph num="(b)"> <text>If a provider does not comply with all Medicare requirements, the provider may not seek reimbursement by the PMHS.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Consent for Services, Orientation, and Advance Directive for Mental Health Services."> <paragraph num="A."> <text>Consent for Services.</text> <paragraph num="(1)"> <text>Before initiating services to an individual, a program shall:</text> <paragraph num="(a)"> <text>Obtain consent from the individual to:</text> <paragraph num="(i)"> <text>Render services to the individual; and</text> </paragraph> <paragraph num="(ii)"> <text>Involve, as appropriate, the appropriate CSA, the individual's family members, and others designated by the individual in the individual's service process;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Review with the individual:</text> <paragraph num="(i)"> <text>That the program may disclose, without consent, certain protected health information, and obtain an acknowledgment from the individual of having received notice that such disclosure may occur;</text> </paragraph> <paragraph num="(ii)"> <text>That the program may disclose, without consent, protected health information to other medical assistance programs and providers; and</text> </paragraph> <paragraph num="(iii)"> <text>The requirements of the Health Insurance Portability and Accountability Act and the Maryland Medical Records Act, as to scope and limits of the confidentiality provisions; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the individual is a minor who cannot consent to services, obtain the appropriate consents and make the required disclosures.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the individual agrees to consent to services but is unable or unwilling to give written consent, a program shall:</text> <paragraph num="(a)"> <text>Document the reasons why the individual cannot give written consent;</text> </paragraph> <paragraph num="(b)"> <text>Verify the individual's verbal consent to services; and</text> </paragraph> <paragraph num="(c)"> <text>Periodically attempt to obtain written consent and document such efforts.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Orientation.</text> <paragraph num="(1)"> <text>On or before the date that an individual receives services, the program director shall ensure that an individual who has been admitted to the program receives information, verbally and in writing, including, but not limited to:</text> <paragraph num="(a)"> <text>A description of the services available;</text> </paragraph> <paragraph num="(b)"> <text>Individual rights and responsibilities;</text> </paragraph> <paragraph num="(c)"> <text>Program hours and on-call procedures;</text> </paragraph> <paragraph num="(d)"> <text>The program's procedures for discharge;</text> </paragraph> <paragraph num="(e)"> <text>The program's procedures for confidentiality;</text> </paragraph> <paragraph num="(f)"> <text>Crisis intervention services; and</text> </paragraph> <paragraph num="(g)"> <text>The complaint and grievance processes.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual's program coordinator shall document in the individual's medical record the individual's receipt of the information contained in §B(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Advance Directive for Mental Health Services. For individuals who are 16 years old or older, the program director shall:</text> <paragraph num="(1)"> <text>Ensure that an individual who has been admitted to the program receives information, verbally and in writing, regarding making an advance directive for mental health services;</text> </paragraph> <paragraph num="(2)"> <text>Document whether an individual has a current advance directive for mental health services;</text> </paragraph> <paragraph num="(3)"> <text>If an individual has a mental health advance directive, include a copy of the document in the individual's medical record; and</text> </paragraph> <paragraph num="(4)"> <text>If an individual requests assistance with making an advance directive for mental health services, assign staff to assist the individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Advisory Committee."> <paragraph num="A."> <text>Membership. A provider that is approved by the Department under this subtitle to operate a program shall have an advisory committee that is composed of members:</text> <paragraph num="(1)"> <text>That reflect the cultural and ethnic profile of the community or communities being served; and</text> </paragraph> <paragraph num="(2)"> <text>At least one-third of whom are individuals who identify themselves as being in one of the following categories:</text> <paragraph num="(a)"> <text>Currently served or were previously served by a mental health program;</text> </paragraph> <paragraph num="(b)"> <text>Family members of individuals who are currently served or were previously served by a mental health program; or</text> </paragraph> <paragraph num="(c)"> <text>Members of a mental health advocacy organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Responsibilities of the Advisory Committee. The advisory committee shall:</text> <paragraph num="(1)"> <text>Establish and maintain a regular meeting schedule;</text> </paragraph> <paragraph num="(2)"> <text>Maintain documentation of the meetings, including:</text> <paragraph num="(a)"> <text>Date;</text> </paragraph> <paragraph num="(b)"> <text>Members present; and</text> </paragraph> <paragraph num="(c)"> <text>Summary of the topics discussed;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Review a program's:</text> <paragraph num="(a)"> <text>Mission;</text> </paragraph> <paragraph num="(b)"> <text>Long-range goals;</text> </paragraph> <paragraph num="(c)"> <text>Policies and procedures; and</text> </paragraph> <paragraph num="(d)"> <text>Services, hours, and location for consistency with community needs;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Advise the program director regarding the items outlined under §B(2) of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>If applicable, annually review whether the program is satisfying its charitable mission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a program has a governing body or board of directors, whichever applies, composed of the membership described under §A of this regulation, and the governing body or board of directors carries out the duties described under §B of this regulation, an additional advisory committee is not required.</text> </paragraph> <paragraph num="D."> <text>Limitation. In order for a program to be eligible to receive funds under this or any other chapter of the Administration's regulations, the following individuals may not serve on the governing body, board of directors, or advisory committee, whichever applies:</text> <paragraph num="(1)"> <text>An immediate family member of an employee of a program;</text> </paragraph> <paragraph num="(2)"> <text>A person who is compensated for providing goods and services to the program; and</text> </paragraph> <paragraph num="(3)"> <text>A person who has served as a member of a governing body, board of directors, or advisory committee of a program that has had a license or approval revoked by the Department within the previous 10 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Collaboration with Core Service Agency (CSA)."> <text>The program director shall:</text> <paragraph num="A."> <text>Submit annually to the CSA, or, when providing services in multiple jurisdictions, the lead CSA, and the Community Services Reimbursement Rate Commission, an annual summary that, at a minimum, includes:</text> <paragraph num="(1)"> <text>Relevant financial statements or documentation and results of a financial audit;</text> </paragraph> <paragraph num="(2)"> <text>Wage and benefit information for each job classification, including, but not limited to:</text> <paragraph num="(a)"> <text>Administrative staff;</text> </paragraph> <paragraph num="(b)"> <text>Supervisory staff;</text> </paragraph> <paragraph num="(c)"> <text>Clinical staff; and</text> </paragraph> <paragraph num="(d)"> <text>Direct care staff;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Other information deemed necessary by the Department and the Community Services Reimbursement Rate Commission;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Collaborate with the CSA in the planning and development of services to be delivered in the CSA's jurisdiction; and</text> </paragraph> <paragraph num="C."> <text>Ensure that the program participates with the CSA's:</text> <paragraph num="(1)"> <text>Protocol for resolution of conflict between the program and an individual served, or another program or agency, or both; and</text> </paragraph> <paragraph num="(2)"> <text>Procedures for prevention of the appearance or occurrence of conflict of interest in the operation of the program's provision of mental health services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Program Model."> <paragraph num="A."> <text>A community mental health program shall develop a program model that promotes recovery and resiliency as required according to the chapter under this subtitle for the specific program.</text> </paragraph> <paragraph num="B."> <text>The program director shall ensure that information and services are provided:</text> <paragraph num="(1)"> <text>In a culturally sensitive manner; and</text> </paragraph> <paragraph num="(2)"> <text>At a suitable reading comprehension level.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Records."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>The program shall, either manually or electronically:</text> <paragraph num="(a)"> <text>Establish a record for an individual who receives services from the program; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that entries in the record are dated, signed, and include the signer's degree or license, or if the signer has no degree or license, the signer's staff position.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The program director shall ensure that individuals' program records are:</text> <paragraph num="(a)"> <text>Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of:</text> <paragraph num="(i)"> <text>Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Relevant federal statutes and regulations, including the Health Insurance Portability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Located so that the records are convenient and available to designated staff;</text> </paragraph> <paragraph num="(c)"> <text>Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and</text> </paragraph> <paragraph num="(d)"> <text>Subject to the requirements of confidentiality laws and regulations, are made available to the Department, the Administration's ASO, the CSA, and the Office of Inspector General, as necessary to carry out required activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Contents of Record. When an individual is enrolled in a program, the program shall maintain a record of, at a minimum:</text> <paragraph num="(1)"> <text>Identifying information, including but not limited to:</text> <paragraph num="(a)"> <text>Name, sex, race, marital status, and date of birth of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Address and telephone number; and</text> </paragraph> <paragraph num="(c)"> <text>As permitted by law, Social Security number;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Name, address, and telephone number of the individual to be contacted in case of emergency;</text> </paragraph> <paragraph num="(3)"> <text>Dates of enrollment and initial service;</text> </paragraph> <paragraph num="(4)"> <text>Source of referral;</text> </paragraph> <paragraph num="(5)"> <text>If the individual has been referred upon discharge from an inpatient facility:</text> <paragraph num="(a)"> <text>A copy of the aftercare plan and discharge summary; or</text> </paragraph> <paragraph num="(b)"> <text>Documentation that the program has requested a copy of the aftercare plan and discharge summary;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If an individual has been court-ordered to receive evaluation or treatment, a copy of the court order;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of verification of the individual's financial information, or, if the individual is a minor, the minor's parent's financial information necessary to implement the Department's requirements on the setting of charges and collection of fees;</text> </paragraph> <paragraph num="(8)"> <text>Presenting problem and history of the presenting problem, including, if known, precipitating factors and, if any, history of substance abuse;</text> </paragraph> <paragraph num="(9)"> <text>Either, if indicated and relevant:</text> <paragraph num="(a)"> <text>Copies of reports and recommendations of prior treatment, tests, and evaluations, including, when received, a report or summary of current physical examination; or</text> </paragraph> <paragraph num="(b)"> <text>Documentation that the program has requested a copy of any reports and recommendations of prior treatment, tests, and evaluations;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>For a minor who is enrolled in a program, copies of legal documents related to the minor's status, including but not limited to:</text> <paragraph num="(a)"> <text>Court orders; and</text> </paragraph> <paragraph num="(b)"> <text>Custody agreements;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>For a minor who is enrolled in a program, an emergency contact form, which is up-to-date and which includes:</text> <paragraph num="(a)"> <text>The name, address, and daytime telephone number of the primary caretaker;</text> </paragraph> <paragraph num="(b)"> <text>The name, address, and telephone number of the primary care provider; and</text> </paragraph> <paragraph num="(c)"> <text>If available, the names, addresses, and daytime telephone numbers of at least two individuals to be contacted in case of emergency when the primary caretaker cannot be reached;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>The consent forms, signed by the individual or the individual's parent or guardian, as appropriate, for:</text> <paragraph num="(a)"> <text>Participation in the program and activities provided by the program; and</text> </paragraph> <paragraph num="(b)"> <text>Releasing information to or requesting information from other agencies, including the CSA, and health care providers;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Documentation of the clinical information as required in the chapter under this subtitle for specific program requirements;</text> </paragraph> <paragraph num="(14)"> <text>If applicable, names and either addresses or telephone numbers of the individual's psychiatrist, therapist, case manager, primary care provider, managed care organization, and insurance carrier; and</text> </paragraph> <paragraph num="(15)"> <text>The individual's discharge plan and summary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Policies and Procedures."> <paragraph num="A."> <text>The program shall have and maintain written policies that, at a minimum include:</text> <paragraph num="(1)"> <text>The program's mission and goals;</text> </paragraph> <paragraph num="(2)"> <text>A description of the organizational structure of the program;</text> </paragraph> <paragraph num="(3)"> <text>Identification of the duties of the program director and, if applicable, the medical director or clinical director; and</text> </paragraph> <paragraph num="(4)"> <text>The policies and procedures for:</text> <paragraph num="(a)"> <text>Ensuring individual rights, including confidentiality, and providing a complaint process;</text> </paragraph> <paragraph num="(b)"> <text>Providing the services in the chapter under this subtitle that outlines the requirements for the specific program;</text> </paragraph> <paragraph num="(c)"> <text>Screening, admission, transition, and discharge;</text> </paragraph> <paragraph num="(d)"> <text>If the program provides case coordination, assisting program enrollees with access to all entitlements, pertinent resources, insurance benefits, and reimbursements for which the individual is eligible;</text> </paragraph> <paragraph num="(e)"> <text>If applicable to the program, storing, handling, prescribing, administering, and disposing of medications;</text> </paragraph> <paragraph num="(f)"> <text>If applicable to the program, monitoring of psychiatric and somatic medication;</text> </paragraph> <paragraph num="(g)"> <text>If applicable, accounting for the use and expenditure of an individual's funds;</text> </paragraph> <paragraph num="(h)"> <text>Staffing, including, if required under the chapter in this subtitle that outlines the provisions for the specific program, 24 hours, on-call and emergency coverage;</text> </paragraph> <paragraph num="(i)"> <text>If the program provides services in a facility, a disaster and emergency evacuation plan;</text> </paragraph> <paragraph num="(j)"> <text>According to federal and State requirements, safety precautions, infection control, and communicable disease control;</text> </paragraph> <paragraph num="(k)"> <text>Incident reporting;</text> </paragraph> <paragraph num="(l)"> <text>Crisis response plan; and</text> </paragraph> <paragraph num="(m)"> <text>Information about any State and federal laws pertaining to civil or criminal penalties for false claims and statements and whistle blower protections, including the necessity for preventing and detecting fraud, waste, and abuse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>At least every 3 years, appropriate program staff shall review and, as necessary, revise the policies and procedures.</text> </paragraph> <paragraph num="C."> <text>The program shall maintain written personnel policies, including, at a minimum:</text> <paragraph num="(1)"> <text>Contents of an employee's personnel file, including, at a minimum:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Current job classification;</text> </paragraph> <paragraph num="(c)"> <text>Current job description;</text> </paragraph> <paragraph num="(d)"> <text>Resume containing educational background, relevant work experience, and specialized skills;</text> </paragraph> <paragraph num="(e)"> <text>Copies of required certificates and licenses and primary source verification;</text> </paragraph> <paragraph num="(f)"> <text>Documentation of a criminal background investigation as follows:</text> <paragraph num="(i)"> <text>If the employee works with or has access to minors, a background investigation following the procedures set forth in Family Law Article, §§5-560 — 5-568, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>If the employee works in a group home, a background investigation following the procedures set forth in Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Information received from the employee's references;</text> </paragraph> <paragraph num="(h)"> <text>Documentation of orientation, continuing education and training activities, and privileges granted; and</text> </paragraph> <paragraph num="(i)"> <text>If the staff person's duties require transportation of staff or individuals served:</text> <paragraph num="(i)"> <text>Proof of a valid driver's license issued in the state of the employee's residence; and</text> </paragraph> <paragraph num="(ii)"> <text>Updated annually, a driver's license report from the appropriate state;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Staff orientation, supervision, training, and education;</text> </paragraph> <paragraph num="(3)"> <text>Method of access to an employee's personnel file;</text> </paragraph> <paragraph num="(4)"> <text>Substance abuse policy;</text> </paragraph> <paragraph num="(5)"> <text>Ethical guidelines for employees; and</text> </paragraph> <paragraph num="(6)"> <text>Confidentiality guidelines regarding disclosure requirements of:</text> <paragraph num="(a)"> <text>Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Relevant federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §§1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Discharge from Services."> <paragraph num="A."> <text>When an individual has attained the goals identified in the individual's service plan, the individual's program coordinator shall begin the process for discharge planning.</text> </paragraph> <paragraph num="B."> <text>Discharge Policy. The program shall have and maintain written policies and procedures, which may be contained in one document, that include:</text> <paragraph num="(1)"> <text>The process for all types of discharge from the program, including:</text> <paragraph num="(a)"> <text>Collaborative discharge;</text> </paragraph> <paragraph num="(b)"> <text>The individual's discontinuation of services;</text> </paragraph> <paragraph num="(c)"> <text>The program's recommendation to discontinue services; and</text> </paragraph> <paragraph num="(d)"> <text>The ASO's determination to discontinue authorization for services; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual's right to appeal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Discharge Plan.</text> <paragraph num="(1)"> <text>The individual's program coordinator and the individual, if appropriate, shall develop a discharge plan that:</text> <paragraph num="(a)"> <text>Is based on an assessment of the individual's current status, service needs, and mutually agreed upon goal attainment;</text> </paragraph> <paragraph num="(b)"> <text>Includes:</text> <paragraph num="(i)"> <text>A brief description of the recommendations for continued treatment, if any;</text> </paragraph> <paragraph num="(ii)"> <text>Referrals for continuing services; and</text> </paragraph> <paragraph num="(iii)"> <text>Information about how the individual can re-access services when needed; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>With proper consent, is developed in collaboration with family or others designated by the individual, and other treatment, rehabilitation, and service providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual's program coordinator shall provide the individual with a copy of the discharge plan as soon as possible, but in no event, not later than the date of discharge.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discharge Summary. Within 10 working days after an individual is discharged from a program, a staff person responsible for coordinating services to the individual shall complete and sign a discharge summary that includes, at a minimum, the:</text> <paragraph num="(1)"> <text>Reason for admission;</text> </paragraph> <paragraph num="(2)"> <text>Reason for discharge;</text> </paragraph> <paragraph num="(3)"> <text>Services provided, including the frequency and duration of services;</text> </paragraph> <paragraph num="(4)"> <text>Progress that was made;</text> </paragraph> <paragraph num="(5)"> <text>Diagnosis at the time of discharge, if appropriate;</text> </paragraph> <paragraph num="(6)"> <text>Current medications, if any;</text> </paragraph> <paragraph num="(7)"> <text>Continuing service recommendations and summary of the transition process; and</text> </paragraph> <paragraph num="(8)"> <text>Extent of the individual's involvement in the discharge plan.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Program's Recommendation to Discontinue Services.</text> <paragraph num="(1)"> <text>If, in consultation with the program director, the program coordinator recommends discontinuing services for an individual for whom, because of the individual's actions, the program's services are not effective, or the individual's clinical needs exceed the program's ability to secure the safety and welfare of the individual or others, the program director shall provide written notice of the intention to discontinue services and recommend referral for alternative services.</text> </paragraph> <paragraph num="(2)"> <text>Except in the case of imminent danger, the program director shall provide the notice at least 30 calendar days before discontinuing services.</text> </paragraph> <paragraph num="(3)"> <text>The program director shall assure that the notice is sent to the individual and, with proper consent, to:</text> <paragraph num="(a)"> <text>Family or others designated by the individual; and</text> </paragraph> <paragraph num="(b)"> <text>If appropriate, the CSA and the Administration's ASO, for referral for alternative services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The notice shall include:</text> <paragraph num="(a)"> <text>The effective date of the action;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the action; and</text> </paragraph> <paragraph num="(c)"> <text>A discharge plan.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If an individual presents as a danger to self or to others, the program director shall make necessary arrangements to try to protect the individual, others, or both, and link the individual with the appropriate level of care.</text> </paragraph> </paragraph> <paragraph num="F."> <text>ASO's Determination to Discontinue Authorization for Services. If the Administration's ASO determines that services are no longer medically necessary, the program coordinator shall follow the provision for discharge outlined in §C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Human Services Development."> <paragraph num="A."> <text>Supervision. The program director shall:</text> <paragraph num="(1)"> <text>Establish a system to ensure ongoing supervision of staff; and</text> </paragraph> <paragraph num="(2)"> <text>Determine the need for staff supervision on the basis of:</text> <paragraph num="(a)"> <text>Credentials, competencies, experience, education, and training;</text> </paragraph> <paragraph num="(b)"> <text>Performance standards and outcome measures identified by the quality management process;</text> </paragraph> <paragraph num="(c)"> <text>Size of caseload; and</text> </paragraph> <paragraph num="(d)"> <text>Severity of illness of individuals enrolled in the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Orientation. The program director shall assure that staff:</text> <paragraph num="(1)"> <text>Within the first week of employment, receive an orientation regarding the:</text> <paragraph num="(a)"> <text>Mission of the program;</text> </paragraph> <paragraph num="(b)"> <text>Fundamental rights of the individuals the program serves, including grievance, complaint, and confidentiality procedures of the program;</text> </paragraph> <paragraph num="(c)"> <text>Psychiatric and medical emergency procedures of the program, including crisis management and suicide prevention; and</text> </paragraph> <paragraph num="(d)"> <text>If the program provides services in a facility, emergency evacuation procedures; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 2 months, receive orientation including, but not limited to, the following:</text> <paragraph num="(a)"> <text>Program policies and procedures;</text> </paragraph> <paragraph num="(b)"> <text>Personnel policies and procedures; and</text> </paragraph> <paragraph num="(c)"> <text>Overview of the public mental health services delivery system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Education. The program director shall assure that staff who provide direct services to individuals participate in at least 8 hours of annual educational activities related to the provision of the program's services.</text> </paragraph> <paragraph num="D."> <text>CPR and First Aid. The program director shall ensure that at least one staff member with certification in cardiopulmonary resuscitation (CPR) and standard first aid is on-site during the hours the program is open.</text> </paragraph> <paragraph num="E."> <text>Students. A program may use students to provide services to individuals only if the students:</text> <paragraph num="(1)"> <text>Are pursuing degrees at accredited colleges or universities toward state licensure as mental health professionals;</text> </paragraph> <paragraph num="(2)"> <text>Deliver services as part of formal fieldwork placements through accredited colleges and universities;</text> </paragraph> <paragraph num="(3)"> <text>Comply with their respective professional licensing laws, including supervision requirements, as outlined in Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Are appropriately screened, oriented to the program's policies and procedures, and supervised.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Volunteers.</text> <paragraph num="(1)"> <text>A program may use volunteers to assist with program activities only if the:</text> <paragraph num="(a)"> <text>Volunteers are at least 16 years old, and with proper consent, if applicable;</text> </paragraph> <paragraph num="(b)"> <text>Volunteers are appropriately screened, oriented to the program's policies and procedures, and supervised; and</text> </paragraph> <paragraph num="(c)"> <text>Program has a written policy regarding the scope of the volunteers' duties.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A volunteer may not substitute for required program staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Quality Management (QM)."> <paragraph num="A."> <text>A program shall establish and maintain a QM process in accordance with the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>QM Plan. The program director shall develop and, at least every 3 years, review a written QM plan that:</text> <paragraph num="(1)"> <text>Provides for an internal, ongoing quality performance evaluation process that describes the:</text> <paragraph num="(a)"> <text>Program goals; and</text> </paragraph> <paragraph num="(b)"> <text>Mechanisms, including staff responsible and resources available, for implementing the QM process;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is oriented to the individuals served and emphasizes recovery, collaboration, continuity of care, accessibility, accountability, and efficiency;</text> </paragraph> <paragraph num="(3)"> <text>Includes a system to evaluate:</text> <paragraph num="(a)"> <text>Quality of care and services rendered to individuals;</text> </paragraph> <paragraph num="(b)"> <text>Staff performance in the provision of the services;</text> </paragraph> <paragraph num="(c)"> <text>Staff competencies; and</text> </paragraph> <paragraph num="(d)"> <text>Appropriateness of the program's:</text> <paragraph num="(i)"> <text>Services, including accessibility and hours of operation;</text> </paragraph> <paragraph num="(ii)"> <text>Staff; and</text> </paragraph> <paragraph num="(iii)"> <text>If the program provides services in a facility, physical plant, and environment;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Includes a process for the adequate collection of data in order to identify problems; and</text> </paragraph> <paragraph num="(5)"> <text>In order for staff to implement actions to correct deviations from the program's established standards, identifies a plan that:</text> <paragraph num="(a)"> <text>Is based on:</text> <paragraph num="(i)"> <text>The data collected under §B(4) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Input from staff and individuals served;</text> </paragraph> <paragraph num="(iii)"> <text>A review of the program's outcomes; and</text> </paragraph> <paragraph num="(iv)"> <text>Current trends in efficient and effective treatment and services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is consistent with the program model and the specialized needs of those served; and</text> </paragraph> <paragraph num="(c)"> <text>Provides for ongoing internal review of the program, including monitoring for effectiveness of changes incorporated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Risk Management (RM). The program director shall develop and, at least every 3 years, review a written RM plan, which may be a component of the QM plan, that:</text> <paragraph num="(1)"> <text>Includes policies and procedures for critical incidents, including:</text> <paragraph num="(a)"> <text>Suicides; and</text> </paragraph> <paragraph num="(b)"> <text>Unfavorable service-related outcomes, including discharges that are not mutually agreed upon;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Includes a mechanism by which the program director reports:</text> <paragraph num="(a)"> <text>An allegation of mental, physical, or sexual abuse or neglect of an individual, as provided under Health-General Article, §10-705, and Family Law Article, Title 5, Subtitle 7, and Title 14, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The death of an individual, as outlined in Regulation .13 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Tracks and evaluates incidents reported under §C(1) and (2) of this regulation and complaints filed under Regulation .16 of this chapter to determine trends.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Service Outcomes. The program director shall:</text> <paragraph num="(1)"> <text>Comply with the outcome reporting requirements as determined by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Report data when required and as specified by the Administration;</text> </paragraph> <paragraph num="(3)"> <text>Conduct and analyze the results of an annual satisfaction survey of the program's consumers;</text> </paragraph> <paragraph num="(4)"> <text>Develop a process to inform the individuals served of the program's service outcomes; and</text> </paragraph> <paragraph num="(5)"> <text>Make programmatic changes as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Reports of Death."> <text>Upon notification of the death of any individual in a State funded or operated program or facility, the administrative head of the program or facility shall:</text> <paragraph num="A."> <text>Report the death according to the provisions of Health-General Article, §10-714(a), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>Use the form required by the Administration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Staff Credentials, Competencies, and Privileges."> <paragraph num="A."> <text>The program director shall ensure that staff and consultants perform only those duties for which the staff and consultants have the appropriate credentials and competencies according to the provisions of this regulation.</text> </paragraph> <paragraph num="B."> <text>Staff Credentials. The program director shall ensure that the program has in effect a process for reviewing credentials that requires the program to collect, verify, review, and document the following information:</text> <paragraph num="(1)"> <text>Education;</text> </paragraph> <paragraph num="(2)"> <text>If required, primary source verification of licenses or certification under Health Occupations Article, Annotated Code of Maryland, to practice a health occupation; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of professional liability insurance that is carried either individually or through the program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff Competencies. The program director, in consultation, if appropriate, with the medical director, clinical director, or program psychiatrist, shall develop and implement:</text> <paragraph num="(1)"> <text>A process by which the program reviews and evaluates:</text> <paragraph num="(a)"> <text>Education, credentials, and additional training;</text> </paragraph> <paragraph num="(b)"> <text>Relevant work experience, including experience with populations served by the program, including but not limited to:</text> <paragraph num="(i)"> <text>Adults with serious and persistent mental illness;</text> </paragraph> <paragraph num="(ii)"> <text>Children and adolescents with serious emotional disturbance; and</text> </paragraph> <paragraph num="(iii)"> <text>Elderly individuals with mental illness; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Competencies required to perform the services rendered;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A system to grant, deny, suspend, or revoke privileges to perform specific services; and</text> </paragraph> <paragraph num="(3)"> <text>Methods for periodic review of credentials and competencies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Staff Criminal Conduct.</text> <paragraph num="(1)"> <text>If a staff member is charged with a crime that involves abuse of an individual, or individuals served by the program, the governing body, board of directors, or advisory committee, whichever applies, shall have a process to determine, without the participation of the staff member in interest, whether the staff member can continue to provide services.</text> </paragraph> <paragraph num="(2)"> <text>If the governing body, board of directors, or advisory committee, whichever applies, determines that the staff member may continue to provide services, the governing body, board of directors, or advisory committee, whichever applies, shall determine the capacity in which the staff member may continue to provide services until the charges are resolved.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Rights."> <paragraph num="A."> <text>A program shall:</text> <paragraph num="(1)"> <text>Explain to an individual enrolled in a program the individual's rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Provide, in writing, information regarding an individual's rights as outlined in §A of this regulation to an individual enrolled in a program; and</text> </paragraph> <paragraph num="(3)"> <text>Prominently display, in accessible centralized locations, the individual's rights as outlined in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A program may not use restraints or seclusion.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Complaints."> <paragraph num="A."> <text>A program shall develop and implement an internal process for the prompt and objective resolution of complaints related to services provided that may be presented by an individual.</text> </paragraph> <paragraph num="B."> <text>The program shall prominently display, in accessible centralized locations, the written description of the complaint process.</text> </paragraph> <paragraph num="C."> <text>A program shall:</text> <paragraph num="(1)"> <text>Prepare the document describing the program's complaint process;</text> </paragraph> <paragraph num="(2)"> <text>Include as part of the written complaint process a form for the individual's use when filing a complaint, and a process by which, if requested by the individual, a program staff member or individual chosen by the individual receiving services, can assist in its completion; and</text> </paragraph> <paragraph num="(3)"> <text>Provide a copy of the program's complaint process for each individual:</text> <paragraph num="(a)"> <text>During the individual's orientation; and</text> </paragraph> <paragraph num="(b)"> <text>At any time upon an individual's request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A program shall include in the complaint process required by §A of this regulation the procedures for registering and responding to the complaints in a timely fashion, which:</text> <paragraph num="(1)"> <text>Require a complaint to be reviewed by the program and, if applicable, the CSA, within 30 calendar days of the program's receipt of the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Allow participation by others designated by the individual;</text> </paragraph> <paragraph num="(3)"> <text>Allow information to be presented to support the individual's position;</text> </paragraph> <paragraph num="(4)"> <text>Ensure the participation of the program staff members who have the authority to implement corrective action;</text> </paragraph> <paragraph num="(5)"> <text>Require documentation of the substance of the complaints and the actions taken;</text> </paragraph> <paragraph num="(6)"> <text>Include a review which:</text> <paragraph num="(a)"> <text>Provides an opportunity, if the individual chooses, to have the individual's complaint reviewed by the CSA director or the CSA director's designee;</text> </paragraph> <paragraph num="(b)"> <text>Requires the program, before making a final determination, to collaborate with the CSA to address the individual's complaint; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Include written notification of the program's determination to:</text> <paragraph num="(a)"> <text>The individual who filed the complaint; and</text> </paragraph> <paragraph num="(b)"> <text>If the program's final determination conflicts with the CSA's opinion, the Administration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>If the program's final determination conflicts with the CSA's opinion, the Administration may review the complaint as indicated.</text> </paragraph> <paragraph num="F."> <text>Unless the individual presents a serious risk to self or others, the program shall postpone taking action until the recommendations of the CSA and the Administration have been made, if applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Grievances."> <text>If an individual has a grievance regarding the denial of services based on eligibility or medical necessity criteria, the individual may file the grievance according to the procedures outlined in COMAR 10.09.70.08.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1995 (21:26 Md. R. 2187)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 5, 1998 (25:20 Md. R. 1530)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .14 repealed and new Regulations .01 — .17 adopted effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective October 6, 2008 (35:20 Md. R. 1775)</annotation> </annotations> </chapter> <chapter num="18" heading="Community Mental Health Programs — Therapeutic Nursery Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to clinical programs that provide a combination of developmental and mental health services in a preschool setting, made accessible and available to children and the families of children who are at risk for or who are emotionally disturbed, who have behavior or adjustment problems, or both.</text> </paragraph> <paragraph num="B."> <text>The Department shall grant approval to an agency to be eligible to receive State funds for providing therapeutic nursery services if the agency meets the requirements of this chapter and COMAR 10.21.16, 10.21.17, and 07.04.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Individualized family service plan (IFSP)” means the plan defined in COMAR 10.09.40.</text> </paragraph> <paragraph num="(2)"> <text>“Learning center” means a designated area of a classroom that serves children in a therapeutic nursery and that is equipped specifically for the development of a particular skill, including, but not limited to, fine motor, gross motor, and socialization.</text> </paragraph> <paragraph num="(3)"> <text>“Primary caretaker” means the child's custodial parent or parents, or the adult with whom the child currently resides.</text> </paragraph> <paragraph num="(4)"> <text>“Program A” means a therapeutic nursery that provides services to children who are younger than 3 years old and whose primary caretakers are present on the site of the therapeutic nursery to participate in the treatment process with the child.</text> </paragraph> <paragraph num="(5)"> <text>“Program B” means a therapeutic nursery that provides services to children who are 3 years old or older, and younger than 5 years old.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Model."> <text>A provider of therapeutic nursery services shall ensure that services:</text> <paragraph num="A."> <text>Are appropriate to the cultural and psychosocial developmental needs of the child;</text> </paragraph> <paragraph num="B."> <text>Are provided:</text> <paragraph num="(1)"> <text>For a minimum of 3 hours per day, 3 days per week at each site; and</text> </paragraph> <paragraph num="(2)"> <text>In either a free-standing program or as an integral component of a preschool program in which services are offered in a therapeutic milieu;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Are provided by staff who:</text> <paragraph num="(1)"> <text>As determined by the program, are appropriately credentialed and privileged; and</text> </paragraph> <paragraph num="(2)"> <text>Organize and manage the milieu to:</text> <paragraph num="(a)"> <text>Foster clinically appropriate social, intellectual, emotional, and physical growth;</text> </paragraph> <paragraph num="(b)"> <text>Handle aggression in a nonpunitive manner that promotes growth and learning;</text> </paragraph> <paragraph num="(c)"> <text>Reinforce the child's ability to function with peers in a social environment;</text> </paragraph> <paragraph num="(d)"> <text>Model and provide opportunities for children to behave in age-appropriate ways, such as:</text> <paragraph num="(i)"> <text>Being playful;</text> </paragraph> <paragraph num="(ii)"> <text>Assuming responsibility for carrying out routine activities;</text> </paragraph> <paragraph num="(iii)"> <text>Exhibiting independence and initiative in planning their own learning;</text> </paragraph> <paragraph num="(iv)"> <text>Getting along with others; and</text> </paragraph> <paragraph num="(v)"> <text>Being courteous;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Facilitate the child's awareness of appropriate behavior in a predictable, constructive, and timely manner; and</text> </paragraph> <paragraph num="(f)"> <text>Help children to make choices and to negotiate disagreements among themselves, rather than resolving conflicts for them;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Are provided in an environment that:</text> <paragraph num="(1)"> <text>Is consistent with existent standards of program design;</text> </paragraph> <paragraph num="(2)"> <text>Is organized so that the child can function in an environment with a minimum of adult direction;</text> </paragraph> <paragraph num="(3)"> <text>Has space that facilitates the activities of each learning center allocated to each center;</text> </paragraph> <paragraph num="(4)"> <text>Has sufficient space and separation between learning centers so that children can engage in activities of their choice without distracting or being distracted by others;</text> </paragraph> <paragraph num="(5)"> <text>Provides materials that are available for children's use and are otherwise appropriately stored; and</text> </paragraph> <paragraph num="(6)"> <text>Displays exhibits of children's work that reflect children's current experiences, developmental level, diversity, and individuality;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Are designed to develop or improve the ability of the primary caretaker to care for the child; and</text> </paragraph> <paragraph num="F."> <text>Maintain linkage with schools and preschool programs to effect transition at the appropriate time and with the necessary support services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Referral and Admission."> <paragraph num="A."> <text>Referral. A therapeutic nursery may accept a referral to the therapeutic nursery from:</text> <paragraph num="(1)"> <text>Education, social service, or health care agency staff;</text> </paragraph> <paragraph num="(2)"> <text>Family members; or</text> </paragraph> <paragraph num="(3)"> <text>Other interested individuals and agencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility. A child is eligible for therapeutic nursery services if the child:</text> <paragraph num="(1)"> <text>Has or is at risk for a mild to severe mental disorder, as defined in the current Diagnostic and Statistical Manual of Mental Disorders, or mild to severe behavioral problems, or both;</text> </paragraph> <paragraph num="(2)"> <text>Is at risk for emotional or behavioral problems because the child:</text> <paragraph num="(a)"> <text>Is experiencing substantial developmental delay or atypical development which, if left untreated, is likely to impair severely the child's ability to function independently, as measured by diagnostic instruments and procedures that meet usual and customary practice standards, in one or more of the following areas:</text> <paragraph num="(i)"> <text>Cognitive development;</text> </paragraph> <paragraph num="(ii)"> <text>Physical development;</text> </paragraph> <paragraph num="(iii)"> <text>Language and speech development;</text> </paragraph> <paragraph num="(iv)"> <text>Psychosocial development; or</text> </paragraph> <paragraph num="(v)"> <text>Self-help skills;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has experienced psychological trauma, as identified by an evaluation by a mental health professional;</text> </paragraph> <paragraph num="(c)"> <text>Has a diagnosed physical or mental condition which has a high probability of resulting in developmental delay; or</text> </paragraph> <paragraph num="(d)"> <text>Has been excluded, for developmental or behavioral problems, from more than one preschool or day care program;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is at risk for emotional or behavioral problems and is a child who is being assessed or has been assessed in a suspected child abuse or neglect investigation pursuant to Family Law Article, §5-701 et seq., Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(4)"> <text>Is at risk for emotional or behavioral problems because of significant family history, as identified by an evaluation by a mental health professional.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Admission.</text> <paragraph num="(1)"> <text>A therapeutic nursery program may admit a child:</text> <paragraph num="(a)"> <text>If the child is:</text> <paragraph num="(i)"> <text>For Program A, younger than 3 years old, and the primary caretaker is available to participate in the treatment process; or</text> </paragraph> <paragraph num="(ii)"> <text>For Program B, 3 years old or older, but younger than 5 years old;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon the written or tape-recorded consent of the child's parent or guardian; and</text> </paragraph> <paragraph num="(c)"> <text>For whom a physician orders therapeutic nursery services as medically necessary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A therapeutic nursery program may not admit a child:</text> <paragraph num="(a)"> <text>Whose primary or sole diagnosis or condition is:</text> <paragraph num="(i)"> <text>Mental retardation;</text> </paragraph> <paragraph num="(ii)"> <text>Visual impairment;</text> </paragraph> <paragraph num="(iii)"> <text>Hearing impairment;</text> </paragraph> <paragraph num="(iv)"> <text>Physical disorder; or</text> </paragraph> <paragraph num="(v)"> <text>Technology dependence; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Who has cognitive deficits that severely limit the ability to benefit from the treatment modalities provided by the therapeutic nursery.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Evaluative Services for the Child."> <paragraph num="A."> <text>Assessment. If a comprehensive developmental assessment has not been completed within the 90 days before admission, before the child's 6th visit, the therapeutic nursery staff shall assure the completion of an assessment, including, when appropriate, standardized measurement, that includes, at a minimum, an assessment of the following:</text> <paragraph num="(1)"> <text>Social and emotional development;</text> </paragraph> <paragraph num="(2)"> <text>Cognitive skills and deficits;</text> </paragraph> <paragraph num="(3)"> <text>Language development;</text> </paragraph> <paragraph num="(4)"> <text>Motor skills, fine and gross;</text> </paragraph> <paragraph num="(5)"> <text>Self-help and adaptive skills;</text> </paragraph> <paragraph num="(6)"> <text>Family history and evaluation;</text> </paragraph> <paragraph num="(7)"> <text>Home environment;</text> </paragraph> <paragraph num="(8)"> <text>Developmental history;</text> </paragraph> <paragraph num="(9)"> <text>Mental status; and</text> </paragraph> <paragraph num="(10)"> <text>Medical history and needs, if any.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Diagnosis. Before the child's 6th visit, an individual qualified to diagnose under the provisions of Health Occupations Article, Annotated Code of Maryland, shall:</text> <paragraph num="(1)"> <text>Conduct a face-to-face evaluation of the child;</text> </paragraph> <paragraph num="(2)"> <text>Formulate and document a diagnosis; and</text> </paragraph> <paragraph num="(3)"> <text>Document the rationale for the diagnosis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Individual Treatment Plan (ITP).</text> <paragraph num="(1)"> <text>Treatment Team. At a minimum, the following individuals shall participate on a child's treatment team:</text> <paragraph num="(a)"> <text>At least one of the following:</text> <paragraph num="(i)"> <text>The therapeutic nursery physician; or</text> </paragraph> <paragraph num="(ii)"> <text>A staff psychologist or psychologist consultant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>At least one other mental health professional;</text> </paragraph> <paragraph num="(c)"> <text>All therapeutic nursery staff who are involved in providing services to the child and family; and</text> </paragraph> <paragraph num="(d)"> <text>If the therapeutic nursery is affiliated with an educational preschool program, the educational staff, as determined appropriate by the therapeutic nursery clinical director.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Plan. Before the child's 6th visit, the therapeutic nursery treatment team, working cooperatively with the child's primary caretaker and classroom teacher, shall prepare an ITP that includes:</text> <paragraph num="(a)"> <text>The diagnostic formulation, as required by §B of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>A description of the child's behavior that includes:</text> <paragraph num="(i)"> <text>Problem list; and</text> </paragraph> <paragraph num="(ii)"> <text>Asset list;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Goals and objectives stated in behavioral, measurable terms;</text> </paragraph> <paragraph num="(d)"> <text>Treatment strategies;</text> </paragraph> <paragraph num="(e)"> <text>Classroom interventions;</text> </paragraph> <paragraph num="(f)"> <text>Home interventions;</text> </paragraph> <paragraph num="(g)"> <text>For children in Program A, that portion of an IFSP, if any, that pertains to therapeutic nursery services; and</text> </paragraph> <paragraph num="(h)"> <text>As relevant, the information about the following from the child's parent, guardian, or primary caretaker, in consultation with appropriate health care or other service providers:</text> <paragraph num="(i)"> <text>Instructions for care in an emergency;</text> </paragraph> <paragraph num="(ii)"> <text>History of allergies, including to medication;</text> </paragraph> <paragraph num="(iii)"> <text>History of seizures;</text> </paragraph> <paragraph num="(iv)"> <text>Medication prescribed;</text> </paragraph> <paragraph num="(v)"> <text>Nutritional requirements, limitations, and feeding procedures; and</text> </paragraph> <paragraph num="(vi)"> <text>Essential medical or nonmedical treatments or procedures, including any advanced directives.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Signatures on the ITP. The following shall sign the ITP:</text> <paragraph num="(a)"> <text>The treatment coordinator of the therapeutic nursery;</text> </paragraph> <paragraph num="(b)"> <text>The therapeutic nursery physician, staff psychologist, or psychologist consultant;</text> </paragraph> <paragraph num="(c)"> <text>If the child is receiving medication, the therapeutic nursery physician;</text> </paragraph> <paragraph num="(d)"> <text>If the individual who signs under the provisions of §C(3)(b) of this regulation is also the treatment coordinator, at least one other mental health professional; and</text> </paragraph> <paragraph num="(e)"> <text>Following review of the ITP, the parent, guardian, or primary caretaker.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>45-Day Review. At a minimum of every 45 days:</text> <paragraph num="(a)"> <text>The treatment coordinator shall:</text> <paragraph num="(i)"> <text>Review the progress on the ITP;</text> </paragraph> <paragraph num="(ii)"> <text>Document in the child's record a description of progress toward goals and changes in goals and interventions based on the review of progress under §C(4)(a)(i) of this regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Update the ITP accordingly; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A minimum of two treating mental health professionals shall sign the 45-day review.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>3-Month Review. Every 3 months, at a treatment team meeting, the:</text> <paragraph num="(a)"> <text>Treatment team shall review the ITP according to the process outlined in §C(4) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Treatment coordinator shall update and sign the 3-month review; and</text> </paragraph> <paragraph num="(c)"> <text>Therapeutic nursery physician, staff psychologist, or psychologist consultant shall sign the ITP review.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing Evaluation. In order to ensure that services to a child are timely and appropriate, therapeutic nursery staff shall document in the child's record:</text> <paragraph num="(1)"> <text>As outlined in the policy and procedures manual, contact notes regarding all clinically relevant face-to-face, telephone, and written contacts with or about the child, including the dates, locations, and types of contacts; and</text> </paragraph> <paragraph num="(2)"> <text>Progress summary notes, entered at least monthly, by staff members involved in the child's treatment and classroom activities, regarding progress toward treatment goals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Treatment and Support Services."> <paragraph num="A."> <text>Therapies. The therapeutic nursery program shall provide the following therapies:</text> <paragraph num="(1)"> <text>If required by the ITP, individual therapy:</text> <paragraph num="(a)"> <text>With the therapeutic nursery mental health professional staff;</text> </paragraph> <paragraph num="(b)"> <text>With the community psychotherapist who is currently treating the child; or</text> </paragraph> <paragraph num="(c)"> <text>By referral;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For children in Program A, conjoint therapy involving an individual child or groups of children with their primary caretakers;</text> </paragraph> <paragraph num="(3)"> <text>Milieu therapy that uses the environment as a tool to assist the child, in keeping with routine developmental expectations, to manage behavior and function appropriately and cooperatively with peers and adults.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Daily Activities. The therapeutic nursery program shall implement, on a consistent, regular basis, a plan for daily activities that:</text> <paragraph num="(1)"> <text>Incorporate a variety of experiences with language, music, art, science, dramatic play, block play, and equipment and materials that promote large and small muscle development;</text> </paragraph> <paragraph num="(2)"> <text>Allow for self-selected and planned as well as individual and small group activities; and</text> </paragraph> <paragraph num="(3)"> <text>Include safe, regular, and developmentally appropriate outdoor play, with supervision consistent with the staff-to-child ratio required under Regulation .08D of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Services for Families. The therapeutic nursery program shall provide services to families, including but not limited to:</text> <paragraph num="(1)"> <text>As indicated by the ITP, counseling or therapy:</text> <paragraph num="(a)"> <text>With the therapeutic nursery mental health professional staff;</text> </paragraph> <paragraph num="(b)"> <text>With the community psychotherapist who is currently treating the child; or</text> </paragraph> <paragraph num="(c)"> <text>By referral;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Orientation for parents, guardians, or primary caretakers to the specialized treatment interventions that are designed to facilitate the child's continued development;</text> </paragraph> <paragraph num="(3)"> <text>Mental health support groups; and</text> </paragraph> <paragraph num="(4)"> <text>Therapeutic home visits.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Interagency Consultation and Referral.</text> <paragraph num="(1)"> <text>Services to Center. If the therapeutic nursery is included within another early childhood program, the therapeutic nursery staff shall provide those services to the early childhood program that the therapeutic nursery staff determine to be appropriate, including, but not limited to:</text> <paragraph num="(a)"> <text>Staff development and training;</text> </paragraph> <paragraph num="(b)"> <text>Mental health consultation regarding specific clinical interventions to be used in relating to therapeutic nursery children;</text> </paragraph> <paragraph num="(c)"> <text>Classroom consultation, including observation and feedback; and</text> </paragraph> <paragraph num="(d)"> <text>When necessary, psychoeducational strategic consultation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Referral Services. For those services indicated in a child's ITP and not provided by the therapeutic nursery staff, the program shall have a policy and procedure for referral for:</text> <paragraph num="(a)"> <text>Therapy, pursuant to §§A(1)(c) and C(1)(c) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluative or support services, including but not limited to:</text> <paragraph num="(i)"> <text>Speech and language;</text> </paragraph> <paragraph num="(ii)"> <text>Vision and hearing;</text> </paragraph> <paragraph num="(iii)"> <text>Special instruction, special education, or other early intervention;</text> </paragraph> <paragraph num="(iv)"> <text>Somatic care;</text> </paragraph> <paragraph num="(v)"> <text>Occupational therapy assessment and treatment; and</text> </paragraph> <paragraph num="(vi)"> <text>Psychological testing.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Discharge and Transitioning."> <paragraph num="A."> <text>Not later than the date of admission, the therapeutic nursery program shall provide a written policy statement on discharge and transition procedures to parents, legal guardians, and primary caretakers.</text> </paragraph> <paragraph num="B."> <text>To the extent practicable, parents, legal guardians, or primary caretakers as well as referring agencies or professionals, and the continuing care providers shall participate in discharge and transition planning.</text> </paragraph> <paragraph num="C."> <text>Within 15 days of discharge, the therapeutic nursery staff shall complete a discharge summary in accordance with the provisions of COMAR 10.21.17.07D(3).</text> </paragraph> <paragraph num="D."> <text>With the consent of a parent or legal guardian as necessary, the therapeutic nursery program shall forward a copy of the discharge summary to the continuing care provider.</text> </paragraph> <paragraph num="E."> <text>Criteria for discharge include but are not limited to:</text> <paragraph num="(1)"> <text>Symptomatic alleviation;</text> </paragraph> <paragraph num="(2)"> <text>Achievement of treatment goals;</text> </paragraph> <paragraph num="(3)"> <text>Readiness for participation in off-site educational programs; or</text> </paragraph> <paragraph num="(4)"> <text>Inability of the enrollee or the primary caretaker, or both, to comply with program requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Program Staff."> <paragraph num="A."> <text>Based on the complexity of the services provided and the number of enrollees in the therapeutic nursery, a therapeutic nursery program shall provide sufficient staff to maintain the staff-to-child ratio provided in §E of this regulation and to carry out the therapeutic goals of the therapeutic nursery.</text> </paragraph> <paragraph num="B."> <text>Therapeutic Nursery Staff. A provider of therapeutic nursery services shall ensure that the therapeutic nursery staff includes, at a minimum:</text> <paragraph num="(1)"> <text>A program director who:</text> <paragraph num="(a)"> <text>Is a mental health professional or has a master's degree in a health services administration field;</text> </paragraph> <paragraph num="(b)"> <text>Is on a site of the therapeutic nursery at least 50 percent of the operating hours of the therapeutic nursery program;</text> </paragraph> <paragraph num="(c)"> <text>If a therapeutic nursery program operates in more than one site, has contact with each site each week; and</text> </paragraph> <paragraph num="(d)"> <text>Is responsible for operational oversight for, at a minimum:</text> <paragraph num="(i)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17;</text> </paragraph> <paragraph num="(ii)"> <text>Recruiting, hiring, and providing administrative supervision of staff;</text> </paragraph> <paragraph num="(iii)"> <text>Developing and implementing the budget;</text> </paragraph> <paragraph num="(iv)"> <text>Keeping the governing body informed of, at a minimum, the program's approval status and performance; and</text> </paragraph> <paragraph num="(v)"> <text>Recruiting and enrolling program participants;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A clinical director who:</text> <paragraph num="(a)"> <text>Is a mental health professional;</text> </paragraph> <paragraph num="(b)"> <text>Is on a site of the therapeutic nursery at least 50 percent of the operating hours of the therapeutic nursery program;</text> </paragraph> <paragraph num="(c)"> <text>If a therapeutic nursery program operates in more than one site, has contact with each site each week;</text> </paragraph> <paragraph num="(d)"> <text>If the clinical director is also the program director, is on a site at the therapeutic nursery program on a full-time basis during the operating hours of the therapeutic nursery program; and</text> </paragraph> <paragraph num="(e)"> <text>Is responsible for oversight for, at a minimum, the following:</text> <paragraph num="(i)"> <text>Development of the ITP;</text> </paragraph> <paragraph num="(ii)"> <text>Providing clinical supervision of staff, including the educational staff of a therapeutic nursery program that is not affiliated with an educational preschool program;</text> </paragraph> <paragraph num="(iii)"> <text>Development of therapeutic strategies that may be used in the classroom;</text> </paragraph> <paragraph num="(iv)"> <text>Development of treatment programs;</text> </paragraph> <paragraph num="(v)"> <text>Quality improvement; and</text> </paragraph> <paragraph num="(vi)"> <text>Inservice training;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A therapeutic nursery physician who:</text> <paragraph num="(a)"> <text>Has completed a residency in child psychiatry in an accredited program;</text> </paragraph> <paragraph num="(b)"> <text>As specified in the employment or consultant contract, is available on a therapeutic nursery site for the amount of time necessary to carry out the duties outlined in §B(3)(c) of this regulation, and, at a minimum:</text> <paragraph num="(i)"> <text>If 25 or fewer children are enrolled in the therapeutic nursery program, for a minimum of 2 hours per week; and</text> </paragraph> <paragraph num="(ii)"> <text>For 1 additional hour per week for every additional one to ten children who are enrolled in the therapeutic nursery program; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is responsible for, at a minimum, the following:</text> <paragraph num="(i)"> <text>Establishing and maintaining appropriate standards for treatment, including therapeutic modalities and prescribing practices;</text> </paragraph> <paragraph num="(ii)"> <text>Unless carried out by other staff qualified under the provisions of Health Occupations Article, Annotated Code of Maryland, as required under the provisions of Regulation .05B and C of this chapter, diagnostic formulation and participation in the development and signing of the ITP and the ITP 3-month reviews;</text> </paragraph> <paragraph num="(iii)"> <text>Clinical supervision of those cases requiring face-to-face medical review;</text> </paragraph> <paragraph num="(iv)"> <text>Review of medication utilization and corrective feedback when utilization is found to be inappropriate; and</text> </paragraph> <paragraph num="(v)"> <text>Medical aspects of quality improvement; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>A staff psychologist or psychologist consultant who:</text> <paragraph num="(a)"> <text>As specified in the employment or consultant contract, is available on the site or sites of the therapeutic nursery program for the amount of time necessary to carry out the duties outlined in §B(4)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for, at a minimum, the following:</text> <paragraph num="(i)"> <text>Unless carried out by other staff qualified under the provisions of Health Occupations Article, Annotated Code of Maryland, as required under the provisions of Regulation .05B and C of this chapter, diagnostic formulation and participation in the development and signing of the ITP and the ITP 3-month reviews;</text> </paragraph> <paragraph num="(ii)"> <text>As needed, performing psychological assessment and testing; and</text> </paragraph> <paragraph num="(iii)"> <text>Making appropriate referral for those cases requiring face-to-face medical review.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment Coordinator. The program director shall assign to each child who is admitted to a therapeutic nursery a treatment coordinator who is a mental health professional.</text> </paragraph> <paragraph num="D."> <text>Educational Staff. If the therapeutic nursery is not affiliated with an educational preschool program, the therapeutic nursery educational staff shall:</text> <paragraph num="(1)"> <text>Be sufficient to carry out the educational programs provided by the therapeutic nursery and the classroom strategies described in the ITPs; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the qualifications required under COMAR 13A.09.09.05C.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Staff-to-Child Ratio. The therapeutic nursery program shall ensure that the following required treatment or education staff-to-child ratio is maintained at all times:</text> <paragraph num="(1)"> <text>For Program A, a staff-to-child ratio of at least one staff member for every five enrollees; and</text> </paragraph> <paragraph num="(2)"> <text>For Program B:</text> <paragraph num="(a)"> <text>If the therapeutic nursery is not affiliated with an educational preschool program, a staff-to-child ratio of at least one staff member for every four enrollees; and</text> </paragraph> <paragraph num="(b)"> <text>If the therapeutic nursery is affiliated with an educational preschool program, a staff-to-child ratio of at least one therapeutic nursery treatment staff member for every 10 preschool children, provided that not more than four children are therapeutic nursery enrollees.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Policies and Procedures."> <text>In addition to the policy and procedure requirements outlined in COMAR 10.21.17.08, a therapeutic nursery program shall adopt policies and procedures for:</text> <paragraph num="A."> <text>Licensure by the Department of Human Services under COMAR 07.04.02;</text> </paragraph> <paragraph num="B."> <text>Physical setting, furnishings, materials, and equipment, as required by Regulations .10 and .11 of this chapter;</text> </paragraph> <paragraph num="C."> <text>Health and safety, as required by Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="D."> <text>Transportation, as required by Regulation .13 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Physical Setting."> <paragraph num="A."> <text>Capacity.</text> <paragraph num="(1)"> <text>The Department shall determine the capacity of a therapeutic nursery based on:</text> <paragraph num="(a)"> <text>Space requirements under §C(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Staff requirements, including the staff-to-child ratio, required under Regulation .08D of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Maintenance of the therapeutic milieu described in Regulation .03B(2) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The program director of the therapeutic nursery program shall limit the number of enrollees to the capacity applied for and approved by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements for the Building. The therapeutic nursery program shall operate the program in a building that conforms to the applicable federal, State, and local laws and regulations, including but not limited to:</text> <paragraph num="(1)"> <text>Zoning;</text> </paragraph> <paragraph num="(2)"> <text>Sanitation;</text> </paragraph> <paragraph num="(3)"> <text>Fire and safety codes; and</text> </paragraph> <paragraph num="(4)"> <text>The requirements of the Americans with Disabilities Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Indoor Space. The therapeutic nursery program shall:</text> <paragraph num="(1)"> <text>For each child enrolled in the therapeutic nursery, provide a minimum of 35 square feet of floor space, not including spaces, such as vestibules and corridors, food preparation areas, bathrooms, adult work areas, and storage spaces, that are not available for the daily program activities of the children; and</text> </paragraph> <paragraph num="(2)"> <text>Provide suitable space for individual, family, group, and play therapies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Outdoor Space. The therapeutic nursery program shall ensure compliance with applicable State and local laws and regulations for outdoor space, including but not limited to water safety requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Materials, Equipment, Furnishings, and Storage."> <paragraph num="A."> <text>Materials and Equipment. In addition to any other requirements of law or regulation, the therapeutic nursery program shall:</text> <paragraph num="(1)"> <text>Provide a sufficient quantity and variety of materials and equipment for indoor and outdoor activities, according to the numbers and ages of the children enrolled, including materials and equipment for:</text> <paragraph num="(a)"> <text>Vigorous play;</text> </paragraph> <paragraph num="(b)"> <text>Creative or dramatic play;</text> </paragraph> <paragraph num="(c)"> <text>Socialization;</text> </paragraph> <paragraph num="(d)"> <text>Manipulation, including construction, exploration of art, music, language arts, and science; and</text> </paragraph> <paragraph num="(e)"> <text>Individual pursuits;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Store materials and equipment so that they are accessible to a child at the appropriate time; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the materials and equipment used by children in the therapeutic nursery are:</text> <paragraph num="(a)"> <text>Safe;</text> </paragraph> <paragraph num="(b)"> <text>Clean;</text> </paragraph> <paragraph num="(c)"> <text>Nontoxic;</text> </paragraph> <paragraph num="(d)"> <text>Free from hazards, including lead paint;</text> </paragraph> <paragraph num="(e)"> <text>In good repair; and</text> </paragraph> <paragraph num="(f)"> <text>Age appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Furnishings. In addition to any other requirements of law or regulation, the therapeutic nursery program shall provide:</text> <paragraph num="(1)"> <text>Furnishings that are proportional to a child's size; and</text> </paragraph> <paragraph num="(2)"> <text>At least the following:</text> <paragraph num="(a)"> <text>Multipurpose tables and chairs; and</text> </paragraph> <paragraph num="(b)"> <text>A suitable crib, bed, cot, or mat and clean bedding for each child who requires a rest period during the hours of operation of the therapeutic nursery.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Storage. In addition to any other requirements of law or regulation, the therapeutic nursery program shall:</text> <paragraph num="(1)"> <text>Provide storage for:</text> <paragraph num="(a)"> <text>Materials and equipment that are for a child's use;</text> </paragraph> <paragraph num="(b)"> <text>Portable equipment intended for outdoor use;</text> </paragraph> <paragraph num="(c)"> <text>Beds and bedding when they are not in use;</text> </paragraph> <paragraph num="(d)"> <text>Each child's clothing and possessions in a space designated for each child; and</text> </paragraph> <paragraph num="(e)"> <text>Materials, equipment, furnishings, and supplies being held in reserve; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ensure that all potentially hazardous items, including knives, tools, poisonous and toxic materials, prescription and nonprescription medicines, cleaning materials, and matches, are stored:</text> <paragraph num="(a)"> <text>In a safe manner;</text> </paragraph> <paragraph num="(b)"> <text>When applicable, in original containers; and</text> </paragraph> <paragraph num="(c)"> <text>Out of the reach of children.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Health and Safety Requirements."> <text>The therapeutic nursery program director shall:</text> <paragraph num="A."> <text>Ensure that a criminal background investigation as required under Family Law Article, §§5-560 — 5-568, Annotated Code of Maryland, has been completed and is on file in each staff member's personnel record;</text> </paragraph> <paragraph num="B."> <text>If a child is involved in an accident or is injured while in attendance at a therapeutic nursery program:</text> <paragraph num="(1)"> <text>Notify the primary caretaker on the day that the accident or injury occurs;</text> </paragraph> <paragraph num="(2)"> <text>If the injury is serious, notify the parent or guardian immediately;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that appropriate treatment is provided; and</text> </paragraph> <paragraph num="(4)"> <text>Document the incident according to the requirements of the risk management policy of the therapeutic nursery;</text> </paragraph> </paragraph> <paragraph num="C."> <text>At all times that children are participating in the therapeutic nursery program, ensure that staff are present who hold current certificates indicating approved training in:</text> <paragraph num="(1)"> <text>Infant and child cardiopulmonary resuscitation (CPR);</text> </paragraph> <paragraph num="(2)"> <text>First aid; and</text> </paragraph> <paragraph num="(3)"> <text>If wading or swimming are therapeutic nursery activities, Red Cross water safety;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prepare an emergency evacuation plan that:</text> <paragraph num="(1)"> <text>Is approved by the local fire authority;</text> </paragraph> <paragraph num="(2)"> <text>Is posted in each room of the therapeutic nursery;</text> </paragraph> <paragraph num="(3)"> <text>The staff and children practice at least monthly, and the staff maintain a written record of the dates and times of the practices; and</text> </paragraph> <paragraph num="(4)"> <text>Includes:</text> <paragraph num="(a)"> <text>Safe routes by which the staff and children may exit each area in the event of fire or other emergency requiring evacuation of the building;</text> </paragraph> <paragraph num="(b)"> <text>The address of a location that can be used by the staff and children in the event of fire or other emergency until the parents, guardians, or primary caretakers of the children are notified; and</text> </paragraph> <paragraph num="(c)"> <text>The provisions that, during an evacuation or a practice, a designated staff member take out of the building the record of attendance for that date and verify the presence of each child in attendance;</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Provide telephones that are accessible to the staff in each activity area in the therapeutic nursery, and post the following information next to each telephone:</text> <paragraph num="(1)"> <text>911 telephone number to summon fire, police, and rescue services;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and telephone number of the therapeutic nursery;</text> </paragraph> <paragraph num="(3)"> <text>Telephone number of the child protective services unit of the local department of social services; and</text> </paragraph> <paragraph num="(4)"> <text>Telephone number of a poison control center;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Release a child:</text> <paragraph num="(1)"> <text>Only to the child's parent, guardian, or primary caretaker; or</text> </paragraph> <paragraph num="(2)"> <text>If so directed by the child's parent, guardian, or primary caretaker, to another individual whose identity is verified;</text> </paragraph> </paragraph> <paragraph num="G."> <text>As required by COMAR 10.06.01:</text> <paragraph num="(1)"> <text>Report communicable diseases; and</text> </paragraph> <paragraph num="(2)"> <text>Restrict attendance by staff and children with communicable diseases;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Not permit anyone to use alcohol or controlled dangerous substances on the premises or to smoke cigarettes, cigars, or pipes in rooms or areas approved for use by a child;</text> </paragraph> <paragraph num="I."> <text>Implement measures to prevent the spread of disease including requiring that staff wash hands and ensure that a child's hands are washed thoroughly with soap and water after toileting, before handling food, after outdoor activities, and at other times necessary to prevent the spread of disease;</text> </paragraph> <paragraph num="J."> <text>Provide for general cleanliness by ensuring that:</text> <paragraph num="(1)"> <text>All surfaces, furnishings, materials, and equipment are clean;</text> </paragraph> <paragraph num="(2)"> <text>Except for emergencies and clean-up activities that are part of the daily program, cleaning is not conducted while rooms are occupied by children;</text> </paragraph> <paragraph num="(3)"> <text>Refuse containers in the building are:</text> <paragraph num="(a)"> <text>Noncombustible; and</text> </paragraph> <paragraph num="(b)"> <text>If they contain soiled diapers, lined with a disposable liner, covered with a lid, and inaccessible to children; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Refuse containers outside the building meet the standards required by local code; and</text> </paragraph> </paragraph> <paragraph num="K."> <text>Provide written notification to each staff member and documentation that each staff member has read and understood the notification regarding:</text> <paragraph num="(1)"> <text>The location of the telephone and the emergency telephone numbers specified in §E of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The location of each child's emergency form;</text> </paragraph> <paragraph num="(3)"> <text>Emergency evacuation procedures;</text> </paragraph> <paragraph num="(4)"> <text>Identity of the staff members who have appropriate first aid, CPR, and Red Cross water safety training;</text> </paragraph> <paragraph num="(5)"> <text>Signs and symptoms of abuse and neglect;</text> </paragraph> <paragraph num="(6)"> <text>The requirements and procedures for reporting suspected child:</text> <paragraph num="(a)"> <text>Abuse directly to the local department of social services or law enforcement agency; and</text> </paragraph> <paragraph num="(b)"> <text>Neglect directly to the local department of social services;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Risk management; and</text> </paragraph> <paragraph num="(8)"> <text>The contents of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Transportation."> <text>If the therapeutic nursery provides transportation, the therapeutic nursery program shall ensure that:</text> <paragraph num="A."> <text>Vehicles used for the transport of therapeutic nursery enrollees are in compliance with the requirements outlined in Transportation Article, Title 22, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Each driver:</text> <paragraph num="(1)"> <text>Possesses a valid Class D license; and</text> </paragraph> <paragraph num="(2)"> <text>Presents the driver's record, certified by the Motor Vehicle Administration, showing not more than two points, at the time of employment and annually after that; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the driver, at least one staff member is present in the vehicle to supervise the children at all times.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1995 (21:26 Md. R. 2187)</annotation> </annotations> </chapter> <chapter num="19" heading="Community Mental Health Programs — Mobile Treatment Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to programs organized to provide intensive, assertive mental health treatment and support services delivered by a multidisciplinary treatment team to an adult or a minor whose mental health treatment needs have not been met through routine, traditional outpatient mental health programs. Services are provided flexibly and in the various community settings determined by the needs of the individual.</text> </paragraph> <paragraph num="B."> <text>The purpose of mobile treatment services (MTS) is to enable the individual to:</text> <paragraph num="(1)"> <text>Remain in the community, thus reducing the individual's admissions to emergency rooms, inpatient facilities, or detention centers; and</text> </paragraph> <paragraph num="(2)"> <text>Achieve transition to less intensive outpatient services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Approval."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing MTS if the program meets the requirements:</text> <paragraph num="A."> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="B."> <text>For administration outlined in COMAR 10.21.17; and</text> </paragraph> <paragraph num="C."> <text>Of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Model."> <text>The program director shall assure that services:</text> <paragraph num="A."> <text>Are therapeutic and are age and culturally appropriate;</text> </paragraph> <paragraph num="B."> <text>Are provided by MTS staff who:</text> <paragraph num="(1)"> <text>As determined by the program, are appropriately credentialed and privileged; and</text> </paragraph> <paragraph num="(2)"> <text>Are available:</text> <paragraph num="(a)"> <text>As indicated in the screening assessment or the individual's ITP, to deliver services at a time and in a setting agreeable to the individual served; and</text> </paragraph> <paragraph num="(b)"> <text>On an on-call basis, 24 hours per day, 7 days per week;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Engage an individual who is unable or unwilling to use traditional mental health services by:</text> <paragraph num="(1)"> <text>Using an assertive approach in making services available and acceptable to the individual by:</text> <paragraph num="(a)"> <text>Identifying and addressing stressors that the individual identifies as priorities;</text> </paragraph> <paragraph num="(b)"> <text>Developing creative individualized approaches in an effort to engage the individual in services; and</text> </paragraph> <paragraph num="(c)"> <text>Recognizing that establishing a therapeutic relationship may take place over an extended period of time; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Being sufficiently flexible to allow for the delivery of service in the setting and at the time that is appropriate for the individual's needs;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Establish between the individual and the MTS staff a therapeutic relationship that includes mutual development of short-term and long-term goals for the individual;</text> </paragraph> <paragraph num="E."> <text>Respect the individual's privacy at the individual's residence by:</text> <paragraph num="(1)"> <text>Except in an emergency, notifying the individual, in advance, of the time that MTS staff will visit the individual's home;</text> </paragraph> <paragraph num="(2)"> <text>Having private conversations;</text> </paragraph> <paragraph num="(3)"> <text>Obtaining the individual's permission to bring anyone else to the individual's home; and</text> </paragraph> <paragraph num="(4)"> <text>If requested, terminating a home visit; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Assist the individual to interact with agencies and others to:</text> <paragraph num="(1)"> <text>Have access to services and entitlements necessary to support adequate living conditions;</text> </paragraph> <paragraph num="(2)"> <text>Maintain continuity of care by coordinating access to various treatment and rehabilitation services;</text> </paragraph> <paragraph num="(3)"> <text>Promote community participation by engaging in age-appropriate social and recreational activities; and</text> </paragraph> <paragraph num="(4)"> <text>Access housing, if necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility, Screening, and Admission."> <paragraph num="A."> <text>Eligibility. An individual is eligible for MTS if:</text> <paragraph num="(1)"> <text>Based on a screening assessment conducted according to the provisions of §B of this regulation, the individual would benefit from services that are:</text> <paragraph num="(a)"> <text>Directed at providing mental health treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Available, by being delivered at a site that is accessible to an individual who:</text> <paragraph num="(i)"> <text>Is homeless;</text> </paragraph> <paragraph num="(ii)"> <text>Has been unable or unwilling to use, on a continuing basis, community-based mental health services that are prescribed for the individual; or</text> </paragraph> <paragraph num="(iii)"> <text>Is in an institution or inpatient facility and would be able to reside in a community setting if the individual received MTS and other appropriate support services; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The services are preauthorized by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.02-1A.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening Assessment.</text> <paragraph num="(1)"> <text>Within 10 working days of receipt of a referral for MTS, the MTS mental health professional who is assigned to conduct screenings shall:</text> <paragraph num="(a)"> <text>Conduct a face-to-face screening assessment with the individual referred to assess the individual's:</text> <paragraph num="(i)"> <text>Needs, strengths, and available resources; and</text> </paragraph> <paragraph num="(ii)"> <text>Willingness to participate in MTS;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Meet with the individual in the individual's home or at a site that is most appropriate to the individual's needs and preferences;</text> </paragraph> <paragraph num="(c)"> <text>As appropriate and with proper consent, meet with the family members and significant others designated by the individual; and</text> </paragraph> <paragraph num="(d)"> <text>Unless the individual is referred to the Administration's ASO for alternative services under §B(2) of this regulation:</text> <paragraph num="(i)"> <text>Determine priority for enrollment based on acuity of the individual's need; and</text> </paragraph> <paragraph num="(ii)"> <text>Arrange an appointment for a psychiatric evaluation, as described under Regulation .05A of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall, in writing, promptly:</text> <paragraph num="(a)"> <text>Inform the individual and, if the individual is a child, the parent or guardian, of the determination and the reason;</text> </paragraph> <paragraph num="(b)"> <text>With proper consent, notify the family or significant others designated by the individual of the determination and of any recommendations for other services; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the CSA and the Administration's ASO for appropriate alternative referral.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Admission. An MTS program shall admit an individual if the services are authorized, as needed, by the Administration's ASO, according to the provisions of COMAR 10.21.17.02-1A.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Evaluative Services Provided."> <paragraph num="A."> <text>Initial MTS Psychiatric Evaluation. Within 30 days of receipt of referral for MTS, the MTS psychiatrist, in collaboration with the individual's assigned treatment coordinator, shall conduct a face-to-face evaluation of the individual to:</text> <paragraph num="(1)"> <text>Collect and evaluate relevant history;</text> </paragraph> <paragraph num="(2)"> <text>Evaluate current mental status, including:</text> <paragraph num="(a)"> <text>The need for medication; and</text> </paragraph> <paragraph num="(b)"> <text>A review of current medications and source of prescriptions;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assess the individual's general physical health, and either:</text> <paragraph num="(a)"> <text>Perform a physical examination;</text> </paragraph> <paragraph num="(b)"> <text>Document a physical examination of the individual during the prior year;</text> </paragraph> <paragraph num="(c)"> <text>Refer the individual for a physical examination; or</text> </paragraph> <paragraph num="(d)"> <text>Waive the requirement that the individual have a physical examination and document the rationale for the waiver;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Formulate and document the psychiatric diagnosis and the rationale for the diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record;</text> </paragraph> <paragraph num="(5)"> <text>In collaboration with the individual:</text> <paragraph num="(a)"> <text>Identify the individual's needs, strengths, and goals; and</text> </paragraph> <paragraph num="(b)"> <text>Assess the individual's level of functioning and availability of family and other social supports;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Document the rationale for the determination that MTS are medically necessary; and</text> </paragraph> <paragraph num="(7)"> <text>Develop an initial brief plan of care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Diagnosis.</text> <paragraph num="(1)"> <text>As required under §A(4) of this regulation, the MTS psychiatrist shall conduct the evaluation and formulate and document the psychiatric diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record.</text> </paragraph> <paragraph num="(2)"> <text>An individual qualified to diagnose under the provisions of Health Occupations Article, Annotated Code of Maryland, may provide continuing psychiatric diagnosis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Individual Treatment Plan (ITP).</text> <paragraph num="(1)"> <text>Treatment Team. At least the following shall participate as members of an individual's MTS treatment team:</text> <paragraph num="(a)"> <text>The MTS psychiatrist or a third-year or fourth-year psychiatric resident who is supervised by the MTS psychiatrist;</text> </paragraph> <paragraph num="(b)"> <text>A licensed social worker;</text> </paragraph> <paragraph num="(c)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(d)"> <text>The individual's treatment coordinator, as defined under Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(e)"> <text>When available, any other staff involved in providing services to the individual.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Initial ITP. Before the 45th day after an individual is admitted to MTS, based on the screening assessment under Regulation .04B of this chapter and psychiatric evaluation under Regulation .05A of this chapter, the treatment team, under the direction of the treatment coordinator, in collaboration with the individual and, with proper consent, family members or significant others designated by the individual, shall prepare an ITP that includes:</text> <paragraph num="(a)"> <text>The psychiatric diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Description of the individual's current behavior and level of functioning that includes the individual's needs and strengths;</text> </paragraph> <paragraph num="(c)"> <text>When relevant to the individual, a description of the family's or significant others' needs and strengths;</text> </paragraph> <paragraph num="(d)"> <text>Short-term and long-term goals, including the plan for transitioning to traditional outpatient mental health services, that are outcome-oriented and that are stated in behavioral, measurable terms;</text> </paragraph> <paragraph num="(e)"> <text>Treatment strategies, including:</text> <paragraph num="(i)"> <text>Recommended type and frequency of interventions;</text> </paragraph> <paragraph num="(ii)"> <text>The method of providing the services required under Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(iii)"> <text>Target dates for goal achievement; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The designation of MTS staff responsible for implementing the elements of the plan.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>3-Month ITP Review. At a minimum of every 3 months at a treatment team meeting, the individual's treatment coordinator, in collaboration with the individual, shall review the ITP and record in the individual's medical record:</text> <paragraph num="(a)"> <text>A description of progress toward the goals;</text> </paragraph> <paragraph num="(b)"> <text>Changes in goals and interventions based on the review of progress documented by the individual's treatment coordinator; and</text> </paragraph> <paragraph num="(c)"> <text>A statement validating the need for continued MTS.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Signature of the ITP and ITP Reviews.</text> <paragraph num="(a)"> <text>The individual shall sign or tape record agreement or disagreement with the plan.</text> </paragraph> <paragraph num="(b)"> <text>The MTS psychiatrist and the individual's treatment coordinator shall sign the ITP and the ITP 3-month reviews.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing Evaluation. In order to ensure that services to an individual are timely and appropriate, the staff shall document in the individual's medical record:</text> <paragraph num="(1)"> <text>Contact notes, regarding all face-to-face and other clinically relevant contacts with or about the individual; and</text> </paragraph> <paragraph num="(2)"> <text>Progress summary notes, entered at least monthly by the individual's treatment coordinator, that include:</text> <paragraph num="(a)"> <text>A description of progress toward the goals; and</text> </paragraph> <paragraph num="(b)"> <text>Changes in goals and interventions based on the review of progress.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Treatment and Support Services Provided."> <paragraph num="A."> <text>Medication Services.</text> <paragraph num="(1)"> <text>Evaluation and Prescription. When prescribing medication for an individual, the MTS psychiatrist shall:</text> <paragraph num="(a)"> <text>Conduct a face-to-face evaluation of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Through a medical history, evidence of a recent physical examination, records review, laboratory testing, or other appropriate measures, assure that there are no contraindications to the prescription of specific medications;</text> </paragraph> <paragraph num="(c)"> <text>Document in the individual's medical record the rationale for prescribing the medication;</text> </paragraph> <paragraph num="(d)"> <text>Explain to the individual or the individual's legal guardian both the benefits and the side effects of prescribed psychiatric medications before and, when appropriate, during treatment and document the explanation in the individual's medical record; and</text> </paragraph> <paragraph num="(e)"> <text>Order and monitor tests at medically recommended intervals and document the results in the individual's medical record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Administration.</text> <paragraph num="(a)"> <text>An individual licensed under Health Occupations Article, Annotated Code of Maryland, to administer medication may do so.</text> </paragraph> <paragraph num="(b)"> <text>A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Monitoring. When required by the individual's ITP, a member of the treatment team credentialed and privileged to do so shall provide the following services:</text> <paragraph num="(a)"> <text>Supporting the individual's self-administration of prescribed medication;</text> </paragraph> <paragraph num="(b)"> <text>To the extent possible, monitoring compliance with instructions appearing on the label;</text> </paragraph> <paragraph num="(c)"> <text>Reading the label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date;</text> </paragraph> <paragraph num="(d)"> <text>Ensuring that each individual has secure, appropriate, and accessible space in which to store medications;</text> </paragraph> <paragraph num="(e)"> <text>Observing and documenting any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority any problems that possibly may be related to the medication; and</text> </paragraph> <paragraph num="(f)"> <text>Reinforcing education on the role and effects of medication in symptom management.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Education Regarding Medication. As required by an individual's ITP, a nurse, a physician, or other privileged and credentialed staff shall educate the individual and, with the individual's consent, the individual's family or significant others, by:</text> <paragraph num="(a)"> <text>Verifying the individual's understanding of the directions for administration of medication; and</text> </paragraph> <paragraph num="(b)"> <text>Providing information regarding:</text> <paragraph num="(i)"> <text>The role, effects, and importance of medication in symptom management;</text> </paragraph> <paragraph num="(ii)"> <text>Expected benefits and expected side effects of prescribed medication; and</text> </paragraph> <paragraph num="(iii)"> <text>Nutritional and dietary expectations and risks related to the individual's medication regimen.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Independent Living Skills Assessment and Training. The MTS staff shall:</text> <paragraph num="(1)"> <text>In collaboration with the individual, assess the individual's level of functioning in the areas of:</text> <paragraph num="(a)"> <text>Community living skills, including but not limited to:</text> <paragraph num="(i)"> <text>Mobility training; and</text> </paragraph> <paragraph num="(ii)"> <text>Money management;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Activities of daily living, including:</text> <paragraph num="(i)"> <text>Meal planning and preparation;</text> </paragraph> <paragraph num="(ii)"> <text>Personal hygiene; and</text> </paragraph> <paragraph num="(iii)"> <text>Grooming; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Interpersonal and socialization skills, including:</text> <paragraph num="(i)"> <text>Communication; and</text> </paragraph> <paragraph num="(ii)"> <text>Leisure and social activities; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Based on the assessment conducted under §B(1) of this regulation, provide rehabilitation activities to assist with and facilitate the individual's acquisition and improvement of independent living skills.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Health Promotion and Training.</text> <paragraph num="(1)"> <text>To supplement and support the somatic health care provided by an individual's primary health care provider, the MTS psychiatrist or registered nurse shall carry out health promotion activities, including but not limited to:</text> <paragraph num="(a)"> <text>Monitoring of a chronic medical condition that is managed by a primary health care provider, including:</text> <paragraph num="(i)"> <text>Teaching on illness prevention and wellness maintenance; and</text> </paragraph> <paragraph num="(ii)"> <text>Reinforcement of instructions given by the primary health care provider;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evaluating an acute problem to determine the most appropriate health care provider and referring the individual to the provider; and</text> </paragraph> <paragraph num="(c)"> <text>Assisting an individual to understand and carry out health-care-related behaviors, including activities related to diagnostic testing preparation and prescribed treatment for acute and short-term illness.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When indicated in the individual's ITP, MTS staff shall provide basic health teaching in the following areas:</text> <paragraph num="(a)"> <text>Nutrition;</text> </paragraph> <paragraph num="(b)"> <text>Exercise;</text> </paragraph> <paragraph num="(c)"> <text>Dental care;</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse prevention; and</text> </paragraph> <paragraph num="(e)"> <text>Prevention of injury and illness at home and in the community.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>MTS staff credentialed and privileged to do so shall provide training in communicable disease prevention, including prevention of sexually transmitted diseases and bloodborne pathogens, including HIV/AIDS.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Interactive Therapies. MTS staff shall provide, as required in the individual's ITP, therapies, including individual, group, and family therapy focused on:</text> <paragraph num="(1)"> <text>Assessment and definition of problems;</text> </paragraph> <paragraph num="(2)"> <text>Planning and goal setting;</text> </paragraph> <paragraph num="(3)"> <text>Development of effective problem-solving techniques;</text> </paragraph> <paragraph num="(4)"> <text>Evaluation of progress; and</text> </paragraph> <paragraph num="(5)"> <text>Other issues raised by the individual.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Crisis Intervention Service. The MTS treatment team shall provide to an individual who is receiving MTS a crisis intervention service that is:</text> <paragraph num="(1)"> <text>Designed to be implemented in the event of a crisis in the home or other setting in which the individual is involved;</text> </paragraph> <paragraph num="(2)"> <text>Explained in terms understandable to the individual; and</text> </paragraph> <paragraph num="(3)"> <text>Available, on an on-call basis, 24 hours per day, 7 days per week.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Support, Linkage, and Advocacy. The MTS treatment team shall assure appropriate coordination with community and family resources that are considered essential to meeting the individual's identified needs, including but not limited to intervention and advocacy with:</text> <paragraph num="(1)"> <text>MTS staff and other community mental health and rehabilitation service providers;</text> </paragraph> <paragraph num="(2)"> <text>Mental health clinic and psychiatric rehabilitation programs;</text> </paragraph> <paragraph num="(3)"> <text>Social service agencies;</text> </paragraph> <paragraph num="(4)"> <text>Courts and detention centers;</text> </paragraph> <paragraph num="(5)"> <text>Providers of needed medical and dental services;</text> </paragraph> <paragraph num="(6)"> <text>Immediate and extended family members;</text> </paragraph> <paragraph num="(7)"> <text>For school age children, the educational system; and</text> </paragraph> <paragraph num="(8)"> <text>Recreational activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="Supported Housing Services for Adults."> <paragraph num="A."> <text>Housing Development. The program director shall ensure that the program:</text> <paragraph num="(1)"> <text>Collaborates with the CSA in developing the CSA's plan for affordable, accessible housing in the community;</text> </paragraph> <paragraph num="(2)"> <text>Maintains information about available regular housing that is:</text> <paragraph num="(a)"> <text>Integrated throughout the community;</text> </paragraph> <paragraph num="(b)"> <text>Not limited as to length of stay, or conditional upon an individual's participation in mental health treatment or support services; and</text> </paragraph> <paragraph num="(c)"> <text>Within the price range that is affordable to individuals enrolled in the program; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In conjunction with the CSA:</text> <paragraph num="(a)"> <text>Attempts to develop financial resources to assist an individual temporarily in such circumstances as an individual's hospitalization or loss of job, benefits, or housemate; and</text> </paragraph> <paragraph num="(b)"> <text>Establishes priorities by which housing financial resources are allocated to individuals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Housing Needs Assessment. The program director shall ensure that program staff, in collaboration with the individual, conduct an assessment of:</text> <paragraph num="(1)"> <text>The individual's housing needs; and</text> </paragraph> <paragraph num="(2)"> <text>If the individual does not have housing that the individual considers adequate, the rehabilitative skills that the individual needs to obtain the housing of choice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Accessing and Sustaining Housing. The program director shall ensure that the program provides, as needed by and acceptable to the individual, services that are directed at:</text> <paragraph num="(1)"> <text>Assisting an individual in making choices about where and with whom to live by developing or restoring the basic social and living skills needed to:</text> <paragraph num="(a)"> <text>Link, when interested, with other individuals with similar interests and housing requirements;</text> </paragraph> <paragraph num="(b)"> <text>Evaluate financial resources, available natural supports, and needed and desired community services;</text> </paragraph> <paragraph num="(c)"> <text>Locate available properties and, when interested, negotiate acquisition; and</text> </paragraph> <paragraph num="(d)"> <text>Secure available financial entitlements and U.S. Department of Housing and Urban Development Section 8 and other types of housing financial assistance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Developing or restoring appropriate basic living skills and supports to keep housing, such as:</text> <paragraph num="(a)"> <text>Responsibilities for upkeep of the property and personal belongings;</text> </paragraph> <paragraph num="(b)"> <text>Maintaining an adequate supply of food and household goods;</text> </paragraph> <paragraph num="(c)"> <text>Development of community resources and natural supports;</text> </paragraph> <paragraph num="(d)"> <text>Housemate conflict resolution; and</text> </paragraph> <paragraph num="(e)"> <text>Landlord-tenant negotiations regarding such issues as rent, needed repairs, and complaints; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Additional support, as determined by the individual's need.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Discharge and Transitioning."> <paragraph num="A."> <text>Discharge Procedures.</text> <paragraph num="(1)"> <text>An MTS program may discharge an individual from MTS only when:</text> <paragraph num="(a)"> <text>The individual:</text> <paragraph num="(i)"> <text>Is unwilling to continue to accept MTS;</text> </paragraph> <paragraph num="(ii)"> <text>Is admitted to an inpatient facility for longer than 3 months; or</text> </paragraph> <paragraph num="(iii)"> <text>Moves from the area served by MTS; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Administration's ASO determines that transition and discharge from MTS is medically appropriate.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When an MTS program discharges an individual under §A(1)(a)(i) or (ii) of this regulation, the MTS program shall, as authorized:</text> <paragraph num="(a)"> <text>Permit the individual to re-enroll in MTS; and</text> </paragraph> <paragraph num="(b)"> <text>Make assertive efforts to re-enroll the individual.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When an MTS program discharges an individual under §A(1)(a)(iii) of this regulation, the MTS program shall, when possible and as authorized, refer the individual for appropriate mental health and support services in the individual's community.</text> </paragraph> <paragraph num="(4)"> <text>When transition and discharge from MTS is authorized under §A(1)(b) of this regulation, the MTS treatment coordinator, in collaboration with an individual, shall:</text> <paragraph num="(a)"> <text>Document the individual's:</text> <paragraph num="(i)"> <text>Achievement of treatment goals;</text> </paragraph> <paragraph num="(ii)"> <text>Anticipated needs for treatment and rehabilitation services; and</text> </paragraph> <paragraph num="(iii)"> <text>Readiness for participation in outpatient mental health clinic (OMHC) or other appropriate outpatient mental health services, as demonstrated by keeping appointments, using transportation independently, obtaining and taking prescribed medications, and actively participating in treatment; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In consultation with the Administration's ASO, prepare a transition plan, according to the provisions of §B of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Transition Services. When the Administration's ASO authorizes a transition plan, the individual's treatment coordinator, in consultation with the Administration's ASO, shall:</text> <paragraph num="(1)"> <text>Arrange transition services in collaboration with:</text> <paragraph num="(a)"> <text>The individual;</text> </paragraph> <paragraph num="(b)"> <text>The treatment team;</text> </paragraph> <paragraph num="(c)"> <text>As appropriate and with proper consent, family members and significant others designated by the individual; and</text> </paragraph> <paragraph num="(d)"> <text>Designated transition service providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide authorized MTS transition services, refer the individual for other appropriate services, and arrange to initiate authorized services before a planned discharge;</text> </paragraph> <paragraph num="(3)"> <text>With proper consent and as authorized by the Administration's ASO, facilitate the individual's transition to other appropriate services by:</text> <paragraph num="(a)"> <text>Inviting the designated provider or providers of mental health services to whom the individual has been referred to participate in the transition planning;</text> </paragraph> <paragraph num="(b)"> <text>Forwarding to the provider or providers a copy of the transition and discharge plan; and</text> </paragraph> <paragraph num="(c)"> <text>For a period of time based on the individual's needs, periodically meeting with the individual and the provider or providers, as necessary to facilitate transition;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the individual does not successfully complete transition, arrange, if authorized by the Administration's ASO, for the continuation of MTS; and</text> </paragraph> <paragraph num="(5)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Required Staff."> <text>A provider of MTS shall ensure that the MTS staff includes, at a minimum:</text> <paragraph num="A."> <text>A program director who:</text> <paragraph num="(1)"> <text>Is a mental health professional;</text> </paragraph> <paragraph num="(2)"> <text>Is available to provide MTS administration and supervision:</text> <paragraph num="(a)"> <text>If fewer than 40 individuals are receiving services, for an amount of time calculated on the basis of 1/2 hour per week for each individual who is receiving services; or</text> </paragraph> <paragraph num="(b)"> <text>If 40 or more individuals are receiving services, 20 hours per week;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is responsible for operational oversight for, at a minimum:</text> <paragraph num="(a)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17 and the day-to-day clinical responsibilities for MTS;</text> </paragraph> <paragraph num="(b)"> <text>Recruiting, hiring, training, and supervising staff;</text> </paragraph> <paragraph num="(c)"> <text>Developing and implementing the budget;</text> </paragraph> <paragraph num="(d)"> <text>Keeping the governing body informed of, at a minimum, the program's approval status and performance;</text> </paragraph> <paragraph num="(e)"> <text>Ensuring that MTS are available to the individual, if needed, 24 hours per day, 7 days per week, and establishing on-call responsibilities;</text> </paragraph> <paragraph num="(f)"> <text>Ensuring continuity of care during the time that an individual is receiving MTS by evaluating caseloads and coordinating staff schedules; and</text> </paragraph> <paragraph num="(g)"> <text>Ensuring that transition services are provided; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>May carry out any of the clinical and training duties of a mental health professional or other MTS staff;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A psychiatrist who:</text> <paragraph num="(1)"> <text>Is involved, for an amount of time calculated on the basis of at least 1/4 hour per week for each individual who is receiving services, in:</text> <paragraph num="(a)"> <text>Consultation with MTS staff; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluating and providing MTS;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ensures that MTS are provided in accordance with accepted standards of medical practice;</text> </paragraph> <paragraph num="(3)"> <text>Following a screening evaluation of an individual completed under Regulation .04B of this chapter, has an initial face-to-face contact with the individual, as required under Regulation .05A of this chapter, to:</text> <paragraph num="(a)"> <text>Formulate and document the psychiatric diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record;</text> </paragraph> <paragraph num="(b)"> <text>Assess medical needs;</text> </paragraph> <paragraph num="(c)"> <text>Confirm the medical necessity of MTS;</text> </paragraph> <paragraph num="(d)"> <text>When appropriate, order MTS for the individual; and</text> </paragraph> <paragraph num="(e)"> <text>Authorize the initial ITP;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is responsible for, at a minimum, the following:</text> <paragraph num="(a)"> <text>Evaluating the individual, face-to-face, at least every 3 months;</text> </paragraph> <paragraph num="(b)"> <text>As required under the provisions of Regulation .05C of this chapter, participating in the development, required periodic review, and signing of an individual's ITP;</text> </paragraph> <paragraph num="(c)"> <text>Prescribing medication and providing other medication services outlined in Regulation .06A of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Providing the appropriate treatment indicated in the individual's ITP; and</text> </paragraph> <paragraph num="(e)"> <text>Supervising psychiatric residents, if any, who provide MTS, including, if duties are delegated, providing, at least monthly, a review of the status of the individuals whom the resident is treating;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>May delegate the following duties to a third-year or fourth-year resident of an accredited program in psychiatry:</text> <paragraph num="(a)"> <text>Except for the initial 3-month evaluation, the periodic evaluations required under §B(4)(a) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Participation in the development, required periodic review, and signing of an individual's ITP, required under §B(4)(b) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>If the resident is a licensed physician, prescribing medication and providing other medication services, as provided under §B(4)(c) of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>As provided in §B(4)(d) of this regulation, providing the appropriate treatment indicated in the individual's ITP; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>May not delegate:</text> <paragraph num="(a)"> <text>The initial psychiatric evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Formulation and documentation of the psychiatric diagnosis or affirmation of a psychiatric diagnosis that has been entered in the individual's MTS medical record; or</text> </paragraph> <paragraph num="(c)"> <text>Ordering of MTS for an individual;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A registered nurse who:</text> <paragraph num="(1)"> <text>Is licensed under the provisions of Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Participates in MTS for an amount of time calculated on the basis of at least 1 hour per week for each individual who is receiving services; and</text> </paragraph> <paragraph num="(3)"> <text>As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties that the nurse is credentialed and privileged to perform, including but not limited to:</text> <paragraph num="(a)"> <text>Medication administration and other medication services outlined in Regulation .06A of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Health promotion and training, as outlined in Regulation .06C of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>At least one social worker who:</text> <paragraph num="(1)"> <text>Is licensed under the provisions of Health Occupations Article, Title 19, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties the social worker is credentialed and privileged to perform, including but not limited to:</text> <paragraph num="(a)"> <text>Interactive therapies, as outlined in Regulation .06D of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Support, linkage, and advocacy, as outlined in Regulation .06F of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Discharge and transition services as outlined in Regulation .07 of this chapter; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>At least one mental health professional who:</text> <paragraph num="(1)"> <text>May include the staff identified in §§C and D of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties that the mental health professional is credentialed and privileged to perform, including but not limited to:</text> <paragraph num="(a)"> <text>Conducting the screening evaluation required under Regulation .04B of this chapter and participating in the initial psychiatric evaluation required under Regulation .05A of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>According to the provisions of Regulation .05C of this chapter, reviewing and signing an individual's ITP;</text> </paragraph> <paragraph num="(c)"> <text>The duties outlined in Regulations .06 and .07 of this chapter that the mental health professional is licensed or credentialed and privileged to perform;</text> </paragraph> <paragraph num="(d)"> <text>When credentialed and privileged by the program to do so, functioning as the treatment coordinator for individuals who are receiving MTS;</text> </paragraph> <paragraph num="(e)"> <text>Supervising direct service providers; and</text> </paragraph> <paragraph num="(f)"> <text>Assuring that, before the provision of MTS and, as needed, on an in-service basis, appropriate training is provided to direct service providers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Treatment Coordinator."> <text>The program director shall assign to each individual who is receiving MTS a mental health professional who is the individual's treatment coordinator, and who shall:</text> <paragraph num="A."> <text>Assess the individual's needs by:</text> <paragraph num="(1)"> <text>Collaborating in the initial psychiatric evaluation conducted according to the provisions of Regulation .05A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Collecting and evaluating relevant history;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Establish and maintain a therapeutic relationship;</text> </paragraph> <paragraph num="C."> <text>Direct the development of the ITP and required periodic updates, as outlined in Regulation .05C of this chapter;</text> </paragraph> <paragraph num="D."> <text>Ensure appropriate linkage with treatment services by providing:</text> <paragraph num="(1)"> <text>Outreach, which includes:</text> <paragraph num="(a)"> <text>Meeting with the individual in the individual's home or at a site that is most appropriate to the individual's needs and preferences; and</text> </paragraph> <paragraph num="(b)"> <text>Crisis intervention;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Advocacy, which includes assisting the individual to acquire treatment and rehabilitation services acceptable to the individual and entitlements, housing, and other basic necessities; and</text> </paragraph> <paragraph num="(3)"> <text>Coordination of service plans with other agencies and providers;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Monitor the progress of the individual by:</text> <paragraph num="(1)"> <text>Conducting periodic assessments of the individual's living situation;</text> </paragraph> <paragraph num="(2)"> <text>Conducting face-to-face assessments of the individual's mental status, including the individual's:</text> <paragraph num="(a)"> <text>Appearance;</text> </paragraph> <paragraph num="(b)"> <text>Behavior;</text> </paragraph> <paragraph num="(c)"> <text>Affect;</text> </paragraph> <paragraph num="(d)"> <text>Thought processes;</text> </paragraph> <paragraph num="(e)"> <text>Judgment; and</text> </paragraph> <paragraph num="(f)"> <text>Insight; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Maintaining progress summary notes, as required under the provisions of Regulation .05D(2) of this chapter;</text> </paragraph> </paragraph> <paragraph num="F."> <text>As required by the individual's ITP, provide interactive therapies delineated under Regulation .06D of this chapter; and</text> </paragraph> <paragraph num="G."> <text>When appropriate, recommend discharge and prepare, with the individual, a discharge plan, according to the provisions of Regulation .07 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Additional Staff."> <text>As needed, based on the number of individuals served, the program director may include on the MTS staff direct service providers who:</text> <paragraph num="A."> <text>May include the staff identified in Regulation .08C and D of this chapter; and</text> </paragraph> <paragraph num="B."> <text>As permitted under Health Occupations Article, Annotated Code of Maryland, perform assigned duties that the direct service provider is credentialed and privileged to perform.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Capacity."> <text>A provider of MTS shall base the capacity of the MTS program on the basis of one full-time treatment staff person for each 12 individuals served.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1995 (21:26 Md. R. 2188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C repealed effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06-1 adopted effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> </annotations> </chapter> <chapter num="20" heading="Community Mental Health Programs — Outpatient Mental Health Centers"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to programs that provide mental health treatment services to individuals on an outpatient basis.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <paragraph num="A."> <text>The following applicants shall be eligible for approval as an outpatient mental health center (OMHC), if the applicant demonstrates experience providing mental health services for a minimum of 1 year:</text> <paragraph num="(1)"> <text>A group practice; or</text> </paragraph> <paragraph num="(2)"> <text>A program currently approved under another Mental Hygiene Administration community mental health program chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing services if the program meets the requirements:</text> <paragraph num="(1)"> <text>Outlined under §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="(3)"> <text>For administration outlined in COMAR 10.21.17;</text> </paragraph> <paragraph num="(4)"> <text>For Medical Assistance providers outlined in COMAR 10.09.36, 10.09.59, and 10.09.70; and</text> </paragraph> <paragraph num="(5)"> <text>Of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>An outpatient mental health center (OMHC) shall provide services that are:</text> <paragraph num="(1)"> <text>Age and culturally appropriate;</text> </paragraph> <paragraph num="(2)"> <text>Coordinated with other components of the service delivery system; and</text> </paragraph> <paragraph num="(3)"> <text>Focused on recovery and resiliency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An OMHC shall ensure that clinical services are only rendered by mental health professionals who are authorized under Health Occupations Article, Annotated Code of Maryland, and appropriately credentialed by the program to perform the service.</text> </paragraph> <paragraph num="C."> <text>An OMHC shall ensure that the services required under this chapter are accessible and available:</text> <paragraph num="(1)"> <text>At least 40 hours per week;</text> </paragraph> <paragraph num="(2)"> <text>During some weekend and evening hours; and</text> </paragraph> <paragraph num="(3)"> <text>For emergency coverage, 24 hours per day, 7 days per week as specified in Regulation .08F of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An OMHC shall:</text> <paragraph num="(1)"> <text>Have a facility that:</text> <paragraph num="(a)"> <text>Meets all relevant federal, State, or local ordinances, laws, regulations, and orders governing the program;</text> </paragraph> <paragraph num="(b)"> <text>Is not located in a private residence;</text> </paragraph> <paragraph num="(c)"> <text>Is accessible to the public; and</text> </paragraph> <paragraph num="(d)"> <text>Contains a secure area where records, logs, and business information may be kept; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prominently display the hours of operation of the facility or office.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Intensive Outpatient Services.</text> <paragraph num="(1)"> <text>An OMHC may provide short-term, intensive outpatient services.</text> </paragraph> <paragraph num="(2)"> <text>If an OMHC provides intensive outpatient services, the services shall:</text> <paragraph num="(a)"> <text>Be delivered by a multidisciplinary team for a minimum of 3 hours of therapeutic services per day; and</text> </paragraph> <paragraph num="(b)"> <text>Include:</text> <paragraph num="(i)"> <text>At least two group therapies; and</text> </paragraph> <paragraph num="(ii)"> <text>Physician services as needed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For individuals receiving intensive outpatient services, the individual's ITP shall be reviewed weekly by the individual and the individual's treatment coordinator.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility, Screening, Enrollment, and Orientation."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>An individual is eligible for services through the public mental health system (PMHS) if the services are preauthorized, if required, by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.03A.</text> </paragraph> <paragraph num="(2)"> <text>In addition to those individuals described in §A(1) of this regulation, an OMHC may provide services to other individuals who wish to contract privately for services.</text> </paragraph> <paragraph num="(3)"> <text>If an OMHC provides services to an individual described in §A(2) of this regulation, an OMHC may not seek reimbursement by the PMHS for providing services to that individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening Assessment.</text> <paragraph num="(1)"> <text>An OMHC licensed mental health professional, in collaboration with the individual referred, shall conduct a screening assessment to assess the individual's goals for recovery, strengths, available resources, and treatment needs:</text> <paragraph num="(a)"> <text>Within 5 working days of receipt of a referral from an inpatient facility for OMHC services; or</text> </paragraph> <paragraph num="(b)"> <text>By the date established under §B(2) of this regulation for all other referrals.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For referrals that are not from an inpatient facility, the program director shall:</text> <paragraph num="(a)"> <text>In collaboration with the medical director, establish a procedure to review clinical acuity as described by the referral source;</text> </paragraph> <paragraph num="(b)"> <text>Based on the review of clinical acuity described in §B(2)(a) of this regulation, establish the date for a screening assessment; and</text> </paragraph> <paragraph num="(c)"> <text>Inform the individual of:</text> <paragraph num="(i)"> <text>The date established for the screening assessment; or</text> </paragraph> <paragraph num="(ii)"> <text>If, due to program capacity, there will be a delay in the screening assessment, a tentative time frame for services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If, following the screening assessment under §B(1) of this regulation, the OMHC program director, or licensed mental health professional designated by the program director, determines that the OMHC's services are not appropriate for an individual referred, the OMHC shall advise the individual and, if appropriate, notify the ASO and CSA.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Enrollment. Unless an individual has been determined to be clinically inappropriate for services under the provisions of §B(3) of this regulation, an OMHC shall:</text> <paragraph num="(1)"> <text>Initiate evaluation and treatment services for an individual who has been referred from an inpatient facility, within 5 working days of the screening assessment conducted under §B(1) of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>For all other referrals screened under §B(2) of this regulation, the program director shall:</text> <paragraph num="(a)"> <text>In collaboration with the medical director, establish a procedure to review clinical acuity as described by the referral source;</text> </paragraph> <paragraph num="(b)"> <text>Assign priority for OMHC services based on clinical acuity;</text> </paragraph> <paragraph num="(c)"> <text>Inform the individual of:</text> <paragraph num="(i)"> <text>The estimated date evaluation and treatment services may be initiated; and</text> </paragraph> <paragraph num="(ii)"> <text>If, due to program capacity, there will be a delay in the initiation of treatment services, alternative services that are available.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Orientation. The program director shall ensure that an individual who has been enrolled in the OMHC, or if the individual is a minor, the minor's parent or guardian, receives an orientation as outlined in COMAR 10.21.17.04B.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluative Services Provided."> <paragraph num="A."> <text>Assessment and Diagnosis. The medical director shall ensure that an appropriate licensed mental health professional shall, by the individual's second visit and based on the initial face-to-face diagnostic evaluation of the individual:</text> <paragraph num="(1)"> <text>Formulate and document in the individual's medical record information that includes:</text> <paragraph num="(a)"> <text>A description of the presenting problem;</text> </paragraph> <paragraph num="(b)"> <text>Relevant history, including family history and somatic problems;</text> </paragraph> <paragraph num="(c)"> <text>Mental status examination; and</text> </paragraph> <paragraph num="(d)"> <text>A diagnosis and the rationale for the diagnosis; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Document:</text> <paragraph num="(a)"> <text>The reason for not formulating a diagnosis; and</text> </paragraph> <paragraph num="(b)"> <text>A plan, including time frame, for formulating a diagnosis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Co-Occurring Substance Abuse Screening Assessment. The face-to-face diagnostic assessment conducted under §A of this regulation shall include a screening assessment, using a scientifically validated, and if available, age appropriate tool, to determine whether the individual has a co-occurring substance abuse disorder.</text> </paragraph> <paragraph num="C."> <text>Additional Assessment for a Minor. In addition to the requirements outlined in §A of this regulation, before a minor's fifth visit, the minor's assigned treatment coordinator shall:</text> <paragraph num="(1)"> <text>Conduct a face-to-face evaluation with the minor to assess the minor's level of functioning and availability of family and other social supports; and</text> </paragraph> <paragraph num="(2)"> <text>If a comprehensive assessment, that includes the elements listed in §C(2) of this regulation, has not been completed within the 6 months before enrollment, assure the completion of an assessment, that includes, at a minimum, the minor's:</text> <paragraph num="(a)"> <text>Developmental history;</text> </paragraph> <paragraph num="(b)"> <text>Educational history and current placement;</text> </paragraph> <paragraph num="(c)"> <text>Home environment;</text> </paragraph> <paragraph num="(d)"> <text>Family history and evaluation of the current family status, including legal custody status;</text> </paragraph> <paragraph num="(e)"> <text>Social, emotional, and cognitive development;</text> </paragraph> <paragraph num="(f)"> <text>Motor, language, and self-care skills development;</text> </paragraph> <paragraph num="(g)"> <text>History, if any, of substance abuse;</text> </paragraph> <paragraph num="(h)"> <text>History, if any, of physical or sexual abuse;</text> </paragraph> <paragraph num="(i)"> <text>History, if any, of out-of-home placements; and</text> </paragraph> <paragraph num="(j)"> <text>Involvement, if any, with the local department of social services or Department of Juvenile Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Review of Somatic Status.</text> <paragraph num="(1)"> <text>According to the provisions described in §D of this regulation and upon an individual's enrollment into the program, an appropriate licensed mental health professional shall document in the individual's medical record:</text> <paragraph num="(a)"> <text>Pertinent past and current somatic medical history including:</text> <paragraph num="(i)"> <text>The individual's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant medical treatment, including medication; and</text> </paragraph> <paragraph num="(iii)"> <text>A recommendation, if any, for somatic care follow-up;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the individual does not have a primary care provider, the plan, if indicated, including the time frame, for the individual's referral to a primary care provider for evaluation and treatment; and</text> </paragraph> <paragraph num="(c)"> <text>An exchange of medical information with the primary care provider.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>With proper consent and if clinically indicated, the individual's treatment coordinator shall maintain and document ongoing collaboration and coordination with the individual's primary care provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Treatment Planning and Documentation."> <paragraph num="A."> <text>Individual Treatment Plan (ITP).</text> <paragraph num="(1)"> <text>Initial ITP.</text> <paragraph num="(a)"> <text>Not later than the fifth visit after an individual is enrolled in an OMHC and based on the assessment conducted under Regulation .05B of this chapter, the treatment coordinator and the individual, and if the individual is a minor, the minor's parent, guardian, or primary caretaker if appropriate, shall develop an ITP in collaboration with:</text> <paragraph num="(i)"> <text>With proper consent, family or others designated by the individual, and others involved in the individual's care; and</text> </paragraph> <paragraph num="(ii)"> <text>Other OMHC staff, as appropriate.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The ITP shall include, at a minimum:</text> <paragraph num="(i)"> <text>The individual's diagnosis;</text> </paragraph> <paragraph num="(ii)"> <text>The individual's presenting needs, strengths, recovery, and treatment expectations and responsibilities;</text> </paragraph> <paragraph num="(iii)"> <text>A description of needed and desired treatment and interventions to be provided, specifying the modality, frequency, and responsible staff;</text> </paragraph> <paragraph num="(iv)"> <text>A description of how the needed and desired treatment will help the individual to manage the individual's psychiatric disorder and to support recovery;</text> </paragraph> <paragraph num="(v)"> <text>Short-term and long-term treatment goals in measurable terms and target dates for each goal; and</text> </paragraph> <paragraph num="(vi)"> <text>If appropriate, identification of, referral for, and collaboration with other services or child service agencies and providers to support the individual's treatment and recovery, including but not limited to mental health residential services, psychiatric rehabilitation services, self-help organizations, vocational programs, substance abuse services, the local department of social services, the local department of juvenile services, schools, and somatic care.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The content of the ITP shall be communicated to:</text> <paragraph num="(i)"> <text>Relevant program staff; and</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, family or others designated by the individual and, if applicable, community mental health programs providing services to the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>ITP Review. As frequently as necessary, as determined by the individual and the individual's treatment coordinator, and at a minimum of every 6 months, the individual and the treatment coordinator shall:</text> <paragraph num="(a)"> <text>Review the ITP with the individuals identified under §A(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Based on the review, record in the individual's medical record:</text> <paragraph num="(i)"> <text>An assessment of the individual's progress toward the accomplishment of previously identified treatment goals that incorporates the perspective of the individual served;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes based on a review of progress;</text> </paragraph> <paragraph num="(iii)"> <text>Changes in treatment strategies; and</text> </paragraph> <paragraph num="(iv)"> <text>Changes in diagnosis, if any; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Communicate the results of the treatment plan review to:</text> <paragraph num="(i)"> <text>Relevant program staff;</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, substance abuse treatment providers and primary care provider, as appropriate;</text> </paragraph> <paragraph num="(iii)"> <text>With proper consent, family or others designated by the individual and community mental health programs providing services to the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Signature of the ITP and Reviews.</text> <paragraph num="(a)"> <text>Except as provided in §A(3)(b) of this regulation, the individual shall sign agreement with the plan and reviews.</text> </paragraph> <paragraph num="(b)"> <text>If the individual is unwilling to sign agreement with the plan and reviews, the individual's treatment coordinator shall:</text> <paragraph num="(i)"> <text>Verify the individual's verbal agreement with the plan and reviews; and</text> </paragraph> <paragraph num="(ii)"> <text>Document the rationale for the individual's refusal to sign.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the individual is a minor, the minor's parent or guardian, or if other than the minor's parent or guardian, the minor's primary caretaker shall sign agreement with the plan and reviews.</text> </paragraph> <paragraph num="(d)"> <text>With proper consent, family or others designated by the individual, including the individual's caregivers, may sign the plan and reviews.</text> </paragraph> <paragraph num="(e)"> <text>At least two licensed mental health professionals who collaborate about the individual's treatment, shall sign the plan and reviews.</text> </paragraph> <paragraph num="(f)"> <text>If the individual is receiving medication prescribed through the OMHC, an OMHC psychiatrist, or Certified Registered Nurse Practitioner in psychiatry, whomever prescribes the medication, shall sign the plan and reviews.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon completion of an ITP or ITP review, an individual's treatment coordinator shall assure that the individual is offered a copy of the plan or review and document the individual's acceptance or decline of the offer in the individual's medical record.</text> </paragraph> <paragraph num="(5)"> <text>Individual Treatment and Rehabilitation Plan (ITRP). Staff may combine the required elements of an ITP and IRP in one document, the ITRP.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Continuing Evaluation and Treatment.</text> <paragraph num="(1)"> <text>Contact Note. Staff shall document each contact with the individual, including, at a minimum:</text> <paragraph num="(a)"> <text>The date;</text> </paragraph> <paragraph num="(b)"> <text>The start time and either the duration or the end time;</text> </paragraph> <paragraph num="(c)"> <text>The individual's chief medical complaint or reason for the visit;</text> </paragraph> <paragraph num="(d)"> <text>The individual's mental status;</text> </paragraph> <paragraph num="(e)"> <text>The delivery of services specified by the ITP;</text> </paragraph> <paragraph num="(f)"> <text>A brief description of the service provided;</text> </paragraph> <paragraph num="(g)"> <text>The plan for changes in treatment, if any;</text> </paragraph> <paragraph num="(h)"> <text>The individual's progress toward treatment goals; and</text> </paragraph> <paragraph num="(i)"> <text>A legible signature, which may include an electronic signature, and printed or typed name of the licensed mental health professional providing care, with the appropriate title.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The treatment coordinator shall document any significant changes or events, including hospitalizations, that affect the individual's treatment.</text> </paragraph> <paragraph num="(3)"> <text>The treatment coordinator shall ensure that the individual's needs and progress are communicated to:</text> <paragraph num="(a)"> <text>Staff involved in the implementation of the ITP; and</text> </paragraph> <paragraph num="(b)"> <text>With proper consent:</text> <paragraph num="(i)"> <text>Community mental health programs providing services to the individual; and</text> </paragraph> <paragraph num="(ii)"> <text>Family or others designated by the individual.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Treatment Services."> <paragraph num="A."> <text>An OMHC shall have the capacity to provide the treatment services outlined in §§B — F of this regulation as required by the individual's ITP.</text> </paragraph> <paragraph num="B."> <text>Mental Health Treatment. The program director shall ensure that licensed mental health professionals provide mental health treatment including:</text> <paragraph num="(1)"> <text>Individual therapy;</text> </paragraph> <paragraph num="(2)"> <text>Family therapy; and</text> </paragraph> <paragraph num="(3)"> <text>Group therapy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Psychological Evaluation and Testing. The program director shall ensure that, if medically necessary and required by an individual's ITP, the OMHC provides psychological evaluation and testing by a staff psychologist or psychologist consultant, or by referral.</text> </paragraph> <paragraph num="D."> <text>Co-Occurring Substance Abuse Treatment.</text> <paragraph num="(1)"> <text>The program director shall ensure that the program provides substance abuse treatment as a component of its mental health program for individuals with secondary co-occurring disorders or has a written plan to coordinate mental health services with a certified substance abuse program if necessary.</text> </paragraph> <paragraph num="(2)"> <text>If the assessment conducted under Regulation .06B of this chapter indicates that the individual has a secondary co-occurring substance abuse disorder, the individual's treatment plan and progress notes shall:</text> <paragraph num="(a)"> <text>If the program is providing substance abuse treatment, reflect the course of treatment relative to the disorder; or</text> </paragraph> <paragraph num="(b)"> <text>If the program is not providing substance abuse treatment, with proper consent and if indicated, include documentation of coordination of care and collaboration with the provider of substance abuse services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Medication Services.</text> <paragraph num="(1)"> <text>The medical director shall ensure that appropriate staff are trained and updated on the use, effect, interactions, and potential side effects of medication used by individuals served by the program.</text> </paragraph> <paragraph num="(2)"> <text>Appropriate licensed mental health professionals shall, as clinically indicated, provide the following services:</text> <paragraph num="(a)"> <text>Prescription;</text> </paragraph> <paragraph num="(b)"> <text>Administration;</text> </paragraph> <paragraph num="(c)"> <text>Monitoring; and</text> </paragraph> <paragraph num="(d)"> <text>Education regarding medication.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prescription. Staff identified under §E(2) of this regulation shall:</text> <paragraph num="(a)"> <text>When initially prescribing medication for an individual:</text> <paragraph num="(i)"> <text>Conduct a face-to-face evaluation of the individual;</text> </paragraph> <paragraph num="(ii)"> <text>Assess whether there are contraindications to prescription of specific medications;</text> </paragraph> <paragraph num="(iii)"> <text>Involve the individual in the choice of medication;</text> </paragraph> <paragraph num="(iv)"> <text>Document in the individual's medical record the rationale for prescribing the medication;</text> </paragraph> <paragraph num="(v)"> <text>Explain the benefits and possible side effects of taking or not taking prescribed psychiatric medications and document the explanation;</text> </paragraph> <paragraph num="(vi)"> <text>With proper consent and if appropriate, promptly notify anyone responsible for administering or monitoring medication, of the medication regimen; and</text> </paragraph> <paragraph num="(vii)"> <text>With proper consent and if clinically indicated, notify the individual's primary care physician of medication prescription, if any; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If managing medication on an ongoing basis:</text> <paragraph num="(i)"> <text>At a minimum of every 90 days, evaluate the individual face-to-face;</text> </paragraph> <paragraph num="(ii)"> <text>Alter medications and adjust dosage as clinically indicated;</text> </paragraph> <paragraph num="(iii)"> <text>Document the rationale for the current prescription;</text> </paragraph> <paragraph num="(iv)"> <text>Order and monitor tests at medically recommended intervals and document results in the individual's medical record;</text> </paragraph> <paragraph num="(v)"> <text>Educate the individual and others designated by the individual about prescribed medications, including the name of medication, dosage, frequency, proper storage, expected results, and potential side effects;</text> </paragraph> <paragraph num="(vi)"> <text>With proper consent and if appropriate, promptly notify anyone responsible for administering or monitoring medication, of any changes in the medication regimen; and</text> </paragraph> <paragraph num="(vii)"> <text>Notify the individual's primary care physician every 6 months of medication changes, if any.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>On-Call and Crisis Intervention Services.</text> <paragraph num="(1)"> <text>The program director shall ensure that on-call and crisis intervention services are provided by a program's licensed mental health professional to an individual who has been enrolled in the OMHC:</text> <paragraph num="(a)"> <text>Face-to-face during the 40 hours that the OMHC is open; or</text> </paragraph> <paragraph num="(b)"> <text>By telephone, on an on-call basis, 24 hours per day, 7 days per week, during the hours the OMHC is not open:</text> <paragraph num="(i)"> <text>Through the OMHC; or</text> </paragraph> <paragraph num="(ii)"> <text>By written agreement with another OMHC or mental health crisis service provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate, a crisis response plan or an advance directive for mental health services shall be developed and documented in the medical record, that:</text> <paragraph num="(a)"> <text>An individual and, if the individual is a minor, the primary caretaker may implement in the event of or to prevent a crisis at home, school, work, or other setting in which the individual is involved; and</text> </paragraph> <paragraph num="(b)"> <text>Is stated in terms that the individual and, if involved, the primary caretaker understand.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Support Services."> <paragraph num="A."> <text>In combination with one or more of the treatment services outlined in Regulation .08 of this chapter, an OMHC shall have the capacity to provide, as required by an individual's ITP, the support services outlined in §§B — E of this regulation.</text> </paragraph> <paragraph num="B."> <text>Referral Services. The program director shall ensure that the OMHC provides recommendations and referral, if appropriate, for:</text> <paragraph num="(1)"> <text>Psychiatric rehabilitation and support services;</text> </paragraph> <paragraph num="(2)"> <text>Somatic care;</text> </paragraph> <paragraph num="(3)"> <text>Speech and language services;</text> </paragraph> <paragraph num="(4)"> <text>Vision and hearing services;</text> </paragraph> <paragraph num="(5)"> <text>Special instruction, special education, or other educational interventions;</text> </paragraph> <paragraph num="(6)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(7)"> <text>Self-help organizations; and</text> </paragraph> <paragraph num="(8)"> <text>Substance abuse services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Education Regarding Medication. A nurse, a physician, or other appropriate licensed mental health professional shall educate the individual, and with proper consent, the individual's family or others designated by the individual, by:</text> <paragraph num="(1)"> <text>Verifying the individual's understanding of the directions for administration of medication; and</text> </paragraph> <paragraph num="(2)"> <text>Providing information regarding:</text> <paragraph num="(a)"> <text>The role, effects, and importance of medication in symptom management;</text> </paragraph> <paragraph num="(b)"> <text>Expected benefits and potential side effects of prescribed medication; and</text> </paragraph> <paragraph num="(c)"> <text>Nutritional and dietary expectations and risks related to the individual's medication regimen.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Case Coordination Services. If indicated, the treatment coordinator shall support the individual to:</text> <paragraph num="(1)"> <text>Apply for all applicable entitlement programs; and</text> </paragraph> <paragraph num="(2)"> <text>Access other needed services and resources, as appropriate.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Linkage with an Individual in a Psychiatric Facility, RTC, RCS Program, or Detention Center. The program director shall maintain written policies and procedures, which may be contained in one document, for the purpose of continuity of care when individuals receive mental health services in more restrictive settings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Program Staff."> <paragraph num="A."> <text>Required Staff. The OMHC shall have staff that is sufficient in numbers and qualifications to provide clinically appropriate services to the individuals served and includes, at a minimum:</text> <paragraph num="(1)"> <text>A program director who is:</text> <paragraph num="(a)"> <text>A licensed mental health professional, or has a master's degree in one of the following fields:</text> <paragraph num="(i)"> <text>Mental health;</text> </paragraph> <paragraph num="(ii)"> <text>Health services; or</text> </paragraph> <paragraph num="(iii)"> <text>Business administration;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Employed by the OMHC at least 20 hours per week; and</text> </paragraph> <paragraph num="(c)"> <text>Responsible for administrative oversight of the OMHC, including, at a minimum:</text> <paragraph num="(i)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17;</text> </paragraph> <paragraph num="(ii)"> <text>Fulfilling the requirements of this chapter;</text> </paragraph> <paragraph num="(iii)"> <text>Ensuring the continuity of service if clinical staff at the OMHC site are unavailable to fulfill their responsibilities to the individuals served;</text> </paragraph> <paragraph num="(iv)"> <text>Ensuring a system of clinical supervision of the multidisciplinary treatment staff; and</text> </paragraph> <paragraph num="(v)"> <text>Having knowledge of all regulatory requirements related to the operation of the program;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A medical director who:</text> <paragraph num="(a)"> <text>Is a psychiatrist;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by and is on site at the OMHC at least 20 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>If employed full time by the program, may also serve as program director; and</text> </paragraph> <paragraph num="(d)"> <text>Has overall responsibility for clinical services, including, at a minimum:</text> <paragraph num="(i)"> <text>Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices;</text> </paragraph> <paragraph num="(ii)"> <text>Medical aspects of quality management;</text> </paragraph> <paragraph num="(iii)"> <text>Adequate physician coverage; and</text> </paragraph> <paragraph num="(iv)"> <text>Ensuring adequate clinical supervision of treatment staff;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A multidisciplinary licensed mental health professional staff that:</text> <paragraph num="(a)"> <text>Provides evaluation and treatment services;</text> </paragraph> <paragraph num="(b)"> <text>Is in addition to the OMHC psychiatrist; and</text> </paragraph> <paragraph num="(c)"> <text>Includes representatives of two different mental health professions both of which are represented on-site 50 percent of the OMHC's regularly scheduled hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Students. The program may use students according to the provisions of COMAR 10.21.17.12E.</text> </paragraph> <paragraph num="C."> <text>Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.12F.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Multi-Facility Programs."> <paragraph num="A."> <text>An OMHC program that operates multiple sites shall assure that each additional site adheres to the application modification as outlined in COMAR 10.21.16.04E.</text> </paragraph> <paragraph num="B."> <text>The program director and the medical director shall, on a routine basis, and as clinically required, provide on-site consultation at each site to ensure adequate clinical and administrative oversight.</text> </paragraph> <paragraph num="C."> <text>The program shall designate for each additional OMHC site:</text> <paragraph num="(1)"> <text>A clinical coordinator who:</text> <paragraph num="(a)"> <text>Is a licensed mental health professional with demonstrated competency in clinical supervision;</text> </paragraph> <paragraph num="(b)"> <text>Is located at each additional OMHC site for 50 percent of the site's regularly scheduled hours;</text> </paragraph> <paragraph num="(c)"> <text>Has regular, direct access to the medical director and all clinical and administrative resources of the OMHC; and</text> </paragraph> <paragraph num="(d)"> <text>Provides clinical oversight of the individuals served;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A psychiatrist who:</text> <paragraph num="(a)"> <text>Need not be the medical director of the OMHC; and</text> </paragraph> <paragraph num="(b)"> <text>Is on-site according to the needs of the individuals served; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A multidisciplinary licensed mental health professional staff that:</text> <paragraph num="(a)"> <text>Provides evaluation and treatment services;</text> </paragraph> <paragraph num="(b)"> <text>Is in addition to the OMHC psychiatrist; and</text> </paragraph> <paragraph num="(c)"> <text>Includes representatives of two different mental health professions both of which are represented on-site 50 percent of the OMHC's regularly scheduled hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Staff at each additional OMHC site shall have direct access to the program director, the medical director, and all other clinical and administrative resources of the OMHC as needed.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 13, 1995 (22:3 Md. R. 153)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 16, 1998 (25:23 Md. R. 1696)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 repealed and new Regulations .01 — .11 adopted effective January 14, 2008 (35:1 Md. R. 19)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective April 29, 2013 (40:8 Md. R. 724)</annotation> </annotations> </chapter> <chapter num="21" heading="Community Mental Health Programs — Psychiatric Rehabilitation Programs for Adults"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the service requirements and staffing standards for a psychiatric rehabilitation program (PRP) that provides psychiatric rehabilitation services to an adult at the program site or at an off-site location, including a residential rehabilitation program, appropriate to the individual's needs.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing PRP services if the program meets the requirements:</text> <paragraph num="A."> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="B."> <text>For administration outlined in COMAR 10.21.17; and</text> </paragraph> <paragraph num="C."> <text>Of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>A provider of PRP services for adults shall:</text> <paragraph num="(1)"> <text>Have a facility or office that:</text> <paragraph num="(a)"> <text>Meets all relevant federal, State, or local ordinances, laws, regulations and orders governing the program;</text> </paragraph> <paragraph num="(b)"> <text>Is not located in a private residence;</text> </paragraph> <paragraph num="(c)"> <text>Is accessible to the public; and</text> </paragraph> <paragraph num="(d)"> <text>Contains a secure area where records, logs, and business information may be kept; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prominently display the hours of operation of the facility or office.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program director shall organize program services and supports to:</text> <paragraph num="(1)"> <text>Facilitate an individual's recovery, including the individual's ability to make decisions about the individual's life and create opportunities for choice regarding:</text> <paragraph num="(a)"> <text>Home;</text> </paragraph> <paragraph num="(b)"> <text>School or work; and</text> </paragraph> <paragraph num="(c)"> <text>Community; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Promote the use of community resources and self-help organizations to support the individual to participate fully in the community.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program director shall ensure that:</text> <paragraph num="(1)"> <text>Services are:</text> <paragraph num="(a)"> <text>Appropriate to the age of the populations being served;</text> </paragraph> <paragraph num="(b)"> <text>Offered at times and places, according to the needs of the individuals served; and</text> </paragraph> <paragraph num="(c)"> <text>Coordinated with other mental health services that the individual is receiving;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the PRP provides services to individuals in a specific age group or with a particular clinical profile, the initiation of service criteria are consistent with the populations to be served; and</text> </paragraph> <paragraph num="(3)"> <text>If the PRP provides services in a facility, the services are provided on a regular basis and include a variety of group and individual rehabilitation activities that incorporate individual rehabilitation goals, needs, and choices.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility, Screening, and Initiation of Service."> <paragraph num="A."> <text>Eligibility. An individual is eligible for PRP services if:</text> <paragraph num="(1)"> <text>The individual is in need of program services to enable the individual to improve or restore independent living and social skills necessary to support the individual's:</text> <paragraph num="(a)"> <text>Recovery;</text> </paragraph> <paragraph num="(b)"> <text>Ability to make informed decisions and choices; and</text> </paragraph> <paragraph num="(c)"> <text>Participation in community life;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual meets medical necessity criteria for PRP services;</text> </paragraph> <paragraph num="(3)"> <text>The individual agrees to apply for medical assistance, as appropriate; and</text> </paragraph> <paragraph num="(4)"> <text>The services are preauthorized, as needed, by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.04A.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening. Within 10 working days of receipt by the program of a complete referral for PRP services:</text> <paragraph num="(1)"> <text>Staff assigned by the program director shall conduct a screening assessment to determine whether rehabilitation services are medically needed by the individual;</text> </paragraph> <paragraph num="(2)"> <text>If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall, in writing:</text> <paragraph num="(a)"> <text>Inform the individual of the determination and the reason;</text> </paragraph> <paragraph num="(b)"> <text>Provide the individual with recommendations for alternative services, if appropriate; and</text> </paragraph> <paragraph num="(c)"> <text>With proper consent, notify the referral source, the family, or others designated by the individual of the determination and of any recommendations for other services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Unless the program director has notified the individual of the determination under §B(2) of this regulation, the program director shall notify the individual whether the program:</text> <paragraph num="(a)"> <text>Accepts the individual, in which case, the program director shall identify a date that the program can initiate services to the individual;</text> </paragraph> <paragraph num="(b)"> <text>Will accept the individual, following an updated review of the individual's eligibility status, when program capacity permits, in which case the program director shall inform the individual of the:</text> <paragraph num="(i)"> <text>Individual's placement on a waiting list, if any; and</text> </paragraph> <paragraph num="(ii)"> <text>Estimated date services may be initiated; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Will accept the individual following the individual's discharge or release from an inpatient facility, RTC, or detention center;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the individual is placed on a waiting list under §B(3)(b) of this regulation, the program staff shall discuss with the individual:</text> <paragraph num="(a)"> <text>The option of remaining on the program's waiting list until the date established under §B(3)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Alternative services that are available.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Entitlements and Fees. PRP staff assigned by the program director shall:</text> <paragraph num="(1)"> <text>Determine if the individual has, or may be eligible, for federal or State entitlements;</text> </paragraph> <paragraph num="(2)"> <text>Assist the individual, if necessary, to apply for all entitlements for which the individual may be eligible if the individual does not have entitlements;</text> </paragraph> <paragraph num="(3)"> <text>Document in the individual's medical record:</text> <paragraph num="(a)"> <text>That the individual has all entitlements; or</text> </paragraph> <paragraph num="(b)"> <text>The outcome of the entitlement application;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Discuss with the individual the charges for services, and, when applicable, the process for determining ability to pay; and</text> </paragraph> <paragraph num="(5)"> <text>Provide written documentation to the individual regarding the charges for services and the process for determining ability to pay.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluation and Planning Services."> <paragraph num="A."> <text>Review of Somatic Status.</text> <paragraph num="(1)"> <text>According to the provisions outlined in this section and upon an individual's enrollment into the program, a staff member assigned by the program director shall document in the individual's medical record:</text> <paragraph num="(a)"> <text>Pertinent past and current medical history including:</text> <paragraph num="(i)"> <text>The individual's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant medical treatment, including medications; and</text> </paragraph> <paragraph num="(iii)"> <text>Needed somatic care follow-up, if any; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When the individual does not have a primary care provider and if indicated, the plan, including the time frame, for the individual's referral to a primary care provider for evaluation and treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When indicated, the individual's rehabilitation coordinator shall communicate with the individual's primary care provider and document the communication in the individual's medical record.</text> </paragraph> <paragraph num="(3)"> <text>When indicated, the individual's rehabilitation coordinator shall discuss with the individual the need for medical and dental care, facilitate access to care, and document the communication in the individual's medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Rehabilitation Assessment.</text> <paragraph num="(1)"> <text>Within 30 calendar days of initiation of PRP services, RRP services, or both, staff assigned by the program director to conduct assessments shall complete a face-to-face rehabilitation assessment with the individual and, with proper consent, family or others designated by the individual.</text> </paragraph> <paragraph num="(2)"> <text>The assigned staff shall document in the rehabilitation assessment, at a minimum:</text> <paragraph num="(a)"> <text>The individual's strengths, skills, wants, and needs in the following areas:</text> <paragraph num="(i)"> <text>Independent living;</text> </paragraph> <paragraph num="(ii)"> <text>Housing;</text> </paragraph> <paragraph num="(iii)"> <text>Employment;</text> </paragraph> <paragraph num="(iv)"> <text>Self-administration and management of medications;</text> </paragraph> <paragraph num="(v)"> <text>Mobility and transportation;</text> </paragraph> <paragraph num="(vi)"> <text>Social relationships and leisure activities;</text> </paragraph> <paragraph num="(vii)"> <text>Education and vocational training;</text> </paragraph> <paragraph num="(viii)"> <text>Adaptive equipment or resources; and</text> </paragraph> <paragraph num="(ix)"> <text>Other factors that may pose a challenge to the individual's successful recovery and rehabilitation;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Current resources and support system;</text> </paragraph> <paragraph num="(c)"> <text>As relevant, a review of the individual's legal status and forensic history, if any;</text> </paragraph> <paragraph num="(d)"> <text>The individual's history of substance abuse, if any;</text> </paragraph> <paragraph num="(e)"> <text>Behaviors, if any, that are potentially dangerous to the individual or others; and</text> </paragraph> <paragraph num="(f)"> <text>For individuals receiving RRP services, the individual's:</text> <paragraph num="(i)"> <text>Need for RRP services;</text> </paragraph> <paragraph num="(ii)"> <text>Ability to perform basic self-care and to maintain personal safety; and</text> </paragraph> <paragraph num="(iii)"> <text>Need for changing intensity of intervention based on the episodic nature of mental illness.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Individual Rehabilitation Plan (IRP).</text> <paragraph num="(1)"> <text>Initial IRP. Within 30 calendar days of initiation of PRP or RRP services and based on the rehabilitation assessment described in §B of this regulation, the individual and the individual's rehabilitation coordinator shall prepare an initial IRP:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>And with proper consent, family or others designated by the individual, and others involved in the individual's care; and</text> </paragraph> <paragraph num="(ii)"> <text>When appropriate and with proper consent, other mental health service providers, as available; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That includes, at a minimum:</text> <paragraph num="(i)"> <text>The individual's recovery and rehabilitation expectations and responsibilities;</text> </paragraph> <paragraph num="(ii)"> <text>A description of needed and desired program services and interventions, and staff responsible for implementation;</text> </paragraph> <paragraph num="(iii)"> <text>A description of how the needed and desired skills and supports will help the individual to manage the individual's psychiatric disorder and to support recovery;</text> </paragraph> <paragraph num="(iv)"> <text>Rehabilitation goals in measurable terms, and target dates for each goal;</text> </paragraph> <paragraph num="(v)"> <text>When appropriate, identification of, recommendations for, and collaboration with, other services to support the individual's recovery and rehabilitation, including but not limited to mental health treatment, residential services, self-help organizations, and somatic care; and</text> </paragraph> <paragraph num="(vi)"> <text>For individuals receiving RRP services, the frequency of residential services and intensity of staff support.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individual Treatment and Rehabilitation Plan (ITRP). With the individual and in collaboration with the mental health treatment coordinator, the rehabilitation coordinator may combine the required elements of an ITP and IRP in one document, the ITRP.</text> </paragraph> <paragraph num="(3)"> <text>Rehabilitation Plan Review. At a minimum of every 6 months, the rehabilitation coordinator, with the individual, shall:</text> <paragraph num="(a)"> <text>Review and record in the individual's medical record:</text> <paragraph num="(i)"> <text>The individual's progress toward the accomplishment of previously identified rehabilitation goals;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes, based on a review of the progress; and</text> </paragraph> <paragraph num="(iii)"> <text>Changes in interventions, as appropriate; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Communicate promptly the results of the review to:</text> <paragraph num="(i)"> <text>Relevant program staff; and</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, family or others designated by the individual, and community mental health programs providing services to the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Signature of the IRP or ITRP and Reviews.</text> <paragraph num="(a)"> <text>The following shall sign that they agree with the IRP or ITRP and reviews:</text> <paragraph num="(i)"> <text>The individual; and</text> </paragraph> <paragraph num="(ii)"> <text>The individual's rehabilitation coordinator.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>With proper consent, family or others designated by the individual, including the individual's caregivers, may sign the IRP or ITRP and reviews.</text> </paragraph> <paragraph num="(c)"> <text>If the individual is unwilling to sign agreement with the IRP or ITRP and reviews, the individual's rehabilitation coordinator shall:</text> <paragraph num="(i)"> <text>Verify the individual's verbal agreement with the IRP or ITRP and reviews; and</text> </paragraph> <paragraph num="(ii)"> <text>Document the rationale for the individual's refusal to sign.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>In addition, for an ITRP, at least two licensed mental health professionals, who collaborate about the individual's treatment, shall sign the ITRP and ITRP reviews, including:</text> <paragraph num="(i)"> <text>The individual's treatment coordinator; and</text> </paragraph> <paragraph num="(ii)"> <text>If the individual is receiving medication prescribed through an outpatient mental health center (OMHC), the OMHC psychiatrist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Upon completion of an IRP, ITRP, or review, an individual's rehabilitation coordinator shall assure that the individual is offered a copy of the plan or review and document the individual's receipt or decline of the offer in the individual's medical record.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing Evaluation.</text> <paragraph num="(1)"> <text>Contact Notes. Staff shall document in the individual's medical record:</text> <paragraph num="(a)"> <text>Each contact with or about the individual, including, at a minimum:</text> <paragraph num="(i)"> <text>The date and location of service;</text> </paragraph> <paragraph num="(ii)"> <text>The start time and either the duration or end time, unless the information is in a readily accessible billing document;</text> </paragraph> <paragraph num="(iii)"> <text>The individual's chief medical complaint or reason for the visit;</text> </paragraph> <paragraph num="(iv)"> <text>The delivery of services specified by the IRP or ITRP;</text> </paragraph> <paragraph num="(v)"> <text>A brief description of the service provided; and</text> </paragraph> <paragraph num="(vi)"> <text>A legible signature, which may include an electronic signature, and printed or typed name of the program staff member providing care, with the appropriate title; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For individuals receiving RRP services, any change in intensity of staff support delivered at the RRP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Monthly Summary Notes. At a minimum, each month the rehabilitation coordinator shall record in the individual's medical record, either a contact note or a progress summary note that includes:</text> <paragraph num="(a)"> <text>An assessment of the individual's progress toward goal achievement that incorporates the perspective of both the individual served and staff involved;</text> </paragraph> <paragraph num="(b)"> <text>Changes in the individual's status; and</text> </paragraph> <paragraph num="(c)"> <text>A summary of the rehabilitation services and interventions provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If not documented in §D(1) or (2) of this regulation, the rehabilitation coordinator shall document any significant changes or events, including hospitalizations, that affect the individual's rehabilitation.</text> </paragraph> <paragraph num="(4)"> <text>The rehabilitation coordinator shall document that the individual's wants and needs and progress are promptly communicated to:</text> <paragraph num="(a)"> <text>Staff involved in the implementation of the IRP; and</text> </paragraph> <paragraph num="(b)"> <text>With proper consent, family or others designated by the individual, and community mental health programs providing services to the individual.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rehabilitation and Support Services Provided."> <paragraph num="A."> <text>Rehabilitation and support services may only be provided:</text> <paragraph num="(1)"> <text>To an individual consistent with the individual's IRP or ITRP; and</text> </paragraph> <paragraph num="(2)"> <text>By staff who have been determined competent by the program to provide the services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Rehabilitation and Recovery Activities. The program director shall ensure that the program provides rehabilitation activities directed toward the individual's recovery and the improvement or restoration of skills, including:</text> <paragraph num="(1)"> <text>Self-care skills, including personal hygiene, grooming, nutrition, dietary planning, food preparation, and self-administration of medication;</text> </paragraph> <paragraph num="(2)"> <text>Social skills, including community integration activities, developing natural supports, and developing linkages with and supporting the individual's participation in community activities;</text> </paragraph> <paragraph num="(3)"> <text>Independent living skills, including:</text> <paragraph num="(a)"> <text>Skills necessary for housing stability;</text> </paragraph> <paragraph num="(b)"> <text>Community awareness;</text> </paragraph> <paragraph num="(c)"> <text>Mobility and transportation skills;</text> </paragraph> <paragraph num="(d)"> <text>Money management;</text> </paragraph> <paragraph num="(e)"> <text>Accessing available entitlements and resources;</text> </paragraph> <paragraph num="(f)"> <text>Supporting the individual to obtain and retain employment; and</text> </paragraph> <paragraph num="(g)"> <text>Wellness self-management; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Activities that support the individual's cultural interests.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medication Services.</text> <paragraph num="(1)"> <text>Administration.</text> <paragraph num="(a)"> <text>An individual licensed to administer medication under Health Occupations Article, Annotated Code of Maryland, may do so.</text> </paragraph> <paragraph num="(b)"> <text>A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Monitoring. A PRP staff member shall provide the following services for psychiatric and somatic medications:</text> <paragraph num="(a)"> <text>Support the individual's self-administration of prescribed medication;</text> </paragraph> <paragraph num="(b)"> <text>Read the medication label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date;</text> </paragraph> <paragraph num="(c)"> <text>To the extent possible, monitor compliance with instructions appearing on the medication label;</text> </paragraph> <paragraph num="(d)"> <text>Ensure that each individual has secure, appropriate, and accessible space in which to store medications;</text> </paragraph> <paragraph num="(e)"> <text>Observe and document any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicate to the prescribing authority any problems that possibly may be related to the medication; and</text> </paragraph> <paragraph num="(f)"> <text>Reinforce, with the individual, education on the role and effects of medication in symptom management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Health Promotion and Training. PRP staff shall encourage health promotion activities, such as proper nutrition and exercise.</text> </paragraph> <paragraph num="E."> <text>Promotion of Individual Wellness Self Management and Recovery.</text> <paragraph num="(1)"> <text>Staff shall:</text> <paragraph num="(a)"> <text>Provide education and information regarding mental illness and recovery; and</text> </paragraph> <paragraph num="(b)"> <text>Support the individual to identify effective strategies to assist the individual to manage the individual's wellness.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The strategies shall include, at a minimum, the individual's identification of:</text> <paragraph num="(a)"> <text>Potential challenging symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Warning signs of relapse;</text> </paragraph> <paragraph num="(c)"> <text>Helpful interventions; and</text> </paragraph> <paragraph num="(d)"> <text>Other people the individual identifies to support the individual's recovery.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The individual's wellness self-management strategies shall be documented and may be incorporated in the individual's IRP, Residential Rehabilitation Program Managed Intervention Plan, as outlined in Regulation .08 of this chapter, mental health advance directive, or any combination of these items.</text> </paragraph> <paragraph num="(4)"> <text>The strategies shall be reviewed at the time of the IRP review and may be revised or revoked at any time at the request of the individual.</text> </paragraph> </paragraph> <paragraph num="F."> <text>On-Call and Emergency Response. The program director shall assure that:</text> <paragraph num="(1)"> <text>On-call and crisis intervention services are available 24 hours per day, 7 days per week, by telephone, to an individual who has been admitted to the PRP; and</text> </paragraph> <paragraph num="(2)"> <text>All relevant staff shall assist the individual to access, as appropriate, the OMHC, mobile crisis, residential crisis services, hospitals, and other service providers that are designated to provide crisis and emergency care and treatment.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Linkage with an Individual in a Psychiatric Inpatient Facility or Detention Center.</text> <paragraph num="(1)"> <text>If an individual who is enrolled in a program is admitted to a psychiatric inpatient facility or detention center, the rehabilitation coordinator shall make reasonable efforts to maintain ongoing communication with the individual and the individual's inpatient treatment team.</text> </paragraph> <paragraph num="(2)"> <text>To the degree permitted by the setting, PRP staff serving the individual shall participate in aftercare or release planning from that setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Residential Rehabilitation Program (RRP) Managed Intervention Plan (MIP)."> <paragraph num="A."> <text>The program director shall:</text> <paragraph num="(1)"> <text>Ensure that the program has a written policy regarding the development of and process for the implementation of a managed intervention plan (MIP) for an individual receiving RRP services; and</text> </paragraph> <paragraph num="(2)"> <text>Upon initiation of service, document that the individual has received the written policy regarding the MIP.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For an individual at risk of an unplanned discharge, the rehabilitation coordinator, in collaboration with the individual, shall prepare an MIP that includes:</text> <paragraph num="(1)"> <text>Identification of the issues or symptoms that prompt the implementation of the MIP;</text> </paragraph> <paragraph num="(2)"> <text>Steps and planned interventions, including, but not limited to:</text> <paragraph num="(a)"> <text>A description of additional individualized services and supports that may be needed;</text> </paragraph> <paragraph num="(b)"> <text>Verbal notification;</text> </paragraph> <paragraph num="(c)"> <text>Written notification;</text> </paragraph> <paragraph num="(d)"> <text>Temporary interruption of RRP services, which shall include:</text> <paragraph num="(i)"> <text>The identification of temporary residential alternatives, if any; and</text> </paragraph> <paragraph num="(ii)"> <text>Notification to the CSA;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Identification of the individuals involved in implementing the MIP; and</text> </paragraph> <paragraph num="(f)"> <text>The signature of the:</text> <paragraph num="(i)"> <text>Individual;</text> </paragraph> <paragraph num="(ii)"> <text>Individual's rehabilitation coordinator;</text> </paragraph> <paragraph num="(iii)"> <text>Individual's family or others, if designated by the individual.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The elements of the MIP may be included in a revised IRP.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supported Housing Services for Adults."> <paragraph num="A."> <text>Housing Development. The program director shall ensure that the program:</text> <paragraph num="(1)"> <text>Collaborates with the CSA to access affordable housing in the community;</text> </paragraph> <paragraph num="(2)"> <text>Maintains information about available regular housing that is:</text> <paragraph num="(a)"> <text>Integrated throughout the community;</text> </paragraph> <paragraph num="(b)"> <text>Not conditional upon an individual's participation in mental health treatment or support services; and</text> </paragraph> <paragraph num="(c)"> <text>Within the price range that is affordable to individuals enrolled in the program; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In conjunction with the CSA:</text> <paragraph num="(a)"> <text>Attempts to develop financial resources to assist an individual temporarily in such circumstances as an individual's hospitalization or loss of job, benefits, or housemate; and</text> </paragraph> <paragraph num="(b)"> <text>Establishes priorities by which housing financial resources are allocated to individuals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Housing Needs Assessment. The program director shall ensure that program staff, in collaboration with the individual, conduct an assessment of:</text> <paragraph num="(1)"> <text>The individual's housing needs; and</text> </paragraph> <paragraph num="(2)"> <text>If the individual does not have housing that the individual considers adequate, the rehabilitative skills that the individual needs to obtain the housing of choice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Accessing and Sustaining Housing. The program director shall ensure that the program provides, as needed by and acceptable to the individual, services that are directed at:</text> <paragraph num="(1)"> <text>Assisting an individual in making choices about where and with whom to live by developing or restoring the basic social and living skills needed to:</text> <paragraph num="(a)"> <text>Link, when interested, with other individuals with similar interests and housing requirements;</text> </paragraph> <paragraph num="(b)"> <text>Evaluate financial resources, available natural supports, and needed and desired community services; and</text> </paragraph> <paragraph num="(c)"> <text>Secure available private and public housing financial assistance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Developing or restoring appropriate basic living skills and supports to keep housing, such as:</text> <paragraph num="(a)"> <text>Responsibilities for upkeep of the property and personal belongings;</text> </paragraph> <paragraph num="(b)"> <text>Development of community resources and natural supports;</text> </paragraph> <paragraph num="(c)"> <text>Housemate conflict resolution; and</text> </paragraph> <paragraph num="(d)"> <text>Landlord-tenant negotiations regarding such issues as rent, needed repairs, and complaints; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providing support, as determined by the individual's need.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Staff Qualifications and Responsibilities."> <paragraph num="A."> <text>Program Director. The program director:</text> <paragraph num="(1)"> <text>Shall have sufficient qualifications, knowledge, and experience to execute the duties of the position;</text> </paragraph> <paragraph num="(2)"> <text>Shall be knowledgeable of the regulations applicable to the program;</text> </paragraph> <paragraph num="(3)"> <text>Shall be responsible for administrative oversight of the PRP including, at a minimum:</text> <paragraph num="(a)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17;</text> </paragraph> <paragraph num="(b)"> <text>Fulfilling the programmatic requirements of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Keeping the advisory committee, or governing body, whichever is applicable, informed of, at a minimum, the program's approval status and performance;</text> </paragraph> <paragraph num="(d)"> <text>Quality management; and</text> </paragraph> <paragraph num="(e)"> <text>Ensuring the development of a staffing plan that identifies the type and number of staff needed to provide a program of rehabilitation and recovery services for individuals with serious mental illness; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>May be responsible for the duties of the psychiatric rehabilitation specialist under §B of this regulation as specified in Regulation .11B — D of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Psychiatric Rehabilitation Specialist. The program director shall employ at least one psychiatric rehabilitation specialist who:</text> <paragraph num="(1)"> <text>Is either a:</text> <paragraph num="(a)"> <text>Licensed mental health professional;</text> </paragraph> <paragraph num="(b)"> <text>Rehabilitation counselor who is currently certified by the Commission on Rehabilitation Counselor Certification; or</text> </paragraph> <paragraph num="(c)"> <text>Bachelor's prepared certified psychiatric rehabilitation practitioner currently certified by the U.S. Psychiatric Rehabilitation Association;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Develops and assures that rehabilitation services meet the needs of the individuals served by the program;</text> </paragraph> <paragraph num="(3)"> <text>Oversees the daily program of rehabilitation services; and</text> </paragraph> <paragraph num="(4)"> <text>Educates direct care staff on how to provide rehabilitation services that correlate to the goals identified in the individual's IRP or ITRP.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Psychiatric Rehabilitation Direct Care Staff. The program shall employ psychiatric rehabilitation direct care staff who:</text> <paragraph num="(1)"> <text>Have 40 hours of PRP training before independently providing PRP services;</text> </paragraph> <paragraph num="(2)"> <text>Have, at a minimum, a high school diploma or equivalency diploma; and</text> </paragraph> <paragraph num="(3)"> <text>Are responsible for implementing the rehabilitation activities outlined in the individual's IRP.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Required Program Staff."> <paragraph num="A."> <text>A provider shall ensure that the staff of the PRP includes the following, who are employed by the PRP for the amounts of time outlined in §§B — D of this regulation:</text> <paragraph num="(1)"> <text>A program director;</text> </paragraph> <paragraph num="(2)"> <text>A psychiatric rehabilitation specialist; and</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric rehabilitation direct care staff.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a PRP has fewer than 30 enrollees, the PRP shall employ either:</text> <paragraph num="(1)"> <text>A program director and a psychiatric rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week; or</text> </paragraph> <paragraph num="(2)"> <text>A program director who is responsible for the duties of the program director and the duties of a psychiatric rehabilitation specialist, if the program director:</text> <paragraph num="(a)"> <text>Has the qualifications described under Regulation .10B(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by the program for 40 hours per week; and</text> </paragraph> <paragraph num="(c)"> <text>Devotes at least 20 hours per week to the development and implementation of rehabilitation services that reflect the needs of the individuals served by the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a PRP has 30 — 100 enrollees, the PRP shall employ either:</text> <paragraph num="(1)"> <text>A program director and a psychiatric rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week, and one of whom is employed for an additional 20 hours; or</text> </paragraph> <paragraph num="(2)"> <text>A program director who is responsible for the duties of the program director and the duties of the psychiatric rehabilitation specialist, if the program director:</text> <paragraph num="(a)"> <text>Has the qualifications described under Regulation .10B(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by the program for 40 hours per week; and</text> </paragraph> <paragraph num="(c)"> <text>Designates staff to devote 20 hours per week to carrying out specific assigned administrative duties.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If a PRP has more than 100 enrollees, the PRP program shall employ:</text> <paragraph num="(1)"> <text>A program director who is employed for 40 hours per week; and</text> </paragraph> <paragraph num="(2)"> <text>A psychiatric rehabilitation specialist or specialists and staff assigned to administrative duties as follows:</text> <paragraph num="(a)"> <text>A psychiatric rehabilitation specialist who is on site 40 hours per week;</text> </paragraph> <paragraph num="(b)"> <text>Two psychiatric rehabilitation specialists, each of whom is on site for 20 hours per week; or</text> </paragraph> <paragraph num="(c)"> <text>If the program director has the qualifications described under Regulation .10B(1) of this chapter:</text> <paragraph num="(i)"> <text>A psychiatric rehabilitation specialist who is employed 20 hours per week; and</text> </paragraph> <paragraph num="(ii)"> <text>Staff designated to devote 20 hours per week carrying out specific assigned administrative duties.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Ratio."> <paragraph num="A."> <text>The program shall maintain an average ratio of at least one rehabilitation staff member serving each ten individuals who are receiving on-site PRP services, or receiving off-site PRP services in a group.</text> </paragraph> <paragraph num="B."> <text>To achieve this ratio, the program:</text> <paragraph num="(1)"> <text>May not include:</text> <paragraph num="(a)"> <text>The program director; or</text> </paragraph> <paragraph num="(b)"> <text>Consultants and volunteers; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May include students only if, in calculating the ratio, five rehabilitation staff are on duty for each student.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Volunteers and Students."> <paragraph num="A."> <text>Students. The program may use students according to the provisions of COMAR 10.21.17.12E.</text> </paragraph> <paragraph num="B."> <text>Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.12F.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 13, 1995 (22:3 Md. R. 153)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 7, 1998 (25:18 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 14, 2008 (35:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective January 21, 2013 (40:1 Md. R. 20)</annotation> </annotations> </chapter> <chapter num="22" heading="Community Mental Health Programs — Residential Rehabilitation Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>The purpose of this chapter is to outline the site, staffing, and service requirements that a psychiatric rehabilitation program (PRP) shall fulfill in order to be eligible to be approved to provide residential rehabilitation program (RRP) services.</text> </paragraph> <paragraph num="B."> <text>The Department may approve a program as an RRP if the applicant:</text> <paragraph num="(1)"> <text>Is approved by the Department under COMAR 10.21.21;</text> </paragraph> <paragraph num="(2)"> <text>Leases or owns at least one residence to be operated under the requirements of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>For a residence of four or more individuals, holds a license under COMAR 10.21.04.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Application and Initial Approval Process."> <paragraph num="A."> <text>Consultation. Before submitting an application, a PRP that is applying for approval to operate an RRP may request assistance regarding the proper compilation of application materials and completion of the application from the Administration or the appropriate:</text> <paragraph num="(1)"> <text>Core service agency (CSA) director; or</text> </paragraph> <paragraph num="(2)"> <text>Residential specialist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Program Application. A PRP that is applying for approval to operate an RRP shall include with the application for program approval under COMAR 10.21.16.03B:</text> <paragraph num="(1)"> <text>A description of the type of service that the program intends to provide, including:</text> <paragraph num="(a)"> <text>An estimate of the total number of individuals to be served by the RRP; and</text> </paragraph> <paragraph num="(b)"> <text>The capacity of the RRP to provide general or intensive staffing, as defined in Regulation .09D of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A copy of the residential specialist's certificate of approval of the residence, as granted under the provisions of §C(4)(a)(i) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Initial Approval of a Residence.</text> <paragraph num="(1)"> <text>Application for Approval of a Residence. A PRP that is applying for approval of a residence as a component of an RRP or an applicant for licensure of a group home under COMAR 10.21.04 shall submit to the residential specialist an application that:</text> <paragraph num="(a)"> <text>Is on the form approved by the Department with the requirement that all questions be answered and all required documents be attached;</text> </paragraph> <paragraph num="(b)"> <text>Includes documentation:</text> <paragraph num="(i)"> <text>That the residence is or will be owned or leased by the applicant;</text> </paragraph> <paragraph num="(ii)"> <text>Of fire, liability, and hazard insurance coverage on the building in which the residence is located; and</text> </paragraph> <paragraph num="(iii)"> <text>Of compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety, that are applicable to housing for individuals without disabilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Review of Application. Within 5 working days of receipt of an application for approval of an RRP residence, the residential specialist shall review the application for completeness, and if the application is:</text> <paragraph num="(a)"> <text>Complete, arrange with the applicant to inspect the residence; or</text> </paragraph> <paragraph num="(b)"> <text>Incomplete, promptly return it to the applicant with written instructions regarding proper completion of the application.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Initial Inspection of Residence. Within 10 working days of receipt of a completed application, in collaboration with a representative of the applicant, the residential specialist, using the residential checklist, shall inspect the residence for compliance with Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Initial Certification of a Residence by a Residential Specialist.</text> <paragraph num="(a)"> <text>Based on the inspection conducted under §C(3) of this regulation, within 5 working days of the inspection, the residential specialist shall issue to the applicant, with copies to the Administration and CSA, one of the following:</text> <paragraph num="(i)"> <text>A certificate of general approval of the residence;</text> </paragraph> <paragraph num="(ii)"> <text>Notice of provisional approval, based on noncompliance with specific site requirements under Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(iii)"> <text>Notice that the residence is not approved, based on noncompliance with specific site requirements under Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the residential specialist issues a notice under §C(4)(a)(ii) or (iii) of this regulation, the residential specialist shall, at the applicant's request:</text> <paragraph num="(i)"> <text>Evaluate the applicant's efforts to attain compliance; and</text> </paragraph> <paragraph num="(ii)"> <text>If necessary, reinspect the residence.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Following an evaluation under §C(4)(b) of this regulation, the residential specialist shall issue one of the following:</text> <paragraph num="(i)"> <text>A certificate of general approval of the residence;</text> </paragraph> <paragraph num="(ii)"> <text>Notice of continued provisional approval; or</text> </paragraph> <paragraph num="(iii)"> <text>Notice of denial of approval, advising the applicant of hearing rights, as provided in COMAR 10.21.16.11 or COMAR 10.21.04.06G, as applicable.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Process for Annual Approval of a Residence."> <paragraph num="A."> <text>Annual Review of a Residence. Within not more than 1 year from the date of the last certificate of approval of a residence, the residential specialist, using the residential checklist, shall:</text> <paragraph num="(1)"> <text>Conduct an on-site evaluation to:</text> <paragraph num="(a)"> <text>Inspect the residence for continued compliance with:</text> <paragraph num="(i)"> <text>The documentation required under Regulation .03C(1)(b) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Site requirements outlined in Regulation .05 of this chapter, using the residential checklist;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Document residents' assessment of the residence and of services described in Regulations .05, .08, and .09 of this chapter through face-to-face interviews, in an RRP residence of:</text> <paragraph num="(i)"> <text>One to three residents, with at least one individual; or</text> </paragraph> <paragraph num="(ii)"> <text>Four or more residents, with at least 30 percent of the individuals living in the residence; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Verify, when appropriate:</text> <paragraph num="(i)"> <text>Residents' collection of entitlements; and</text> </paragraph> <paragraph num="(ii)"> <text>The program's fee collections;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Based on the inspection conducted under §A(1)(a) of this regulation, issue the certification or notice described in Regulation .03C(4)(a) of this chapter to the RRP program director, with copies to the:</text> <paragraph num="(a)"> <text>PRP program director; and</text> </paragraph> <paragraph num="(b)"> <text>Director of the CSA; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notify the RRP program director, in writing, of significant information collected under §A(1)(b) or (c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Noncompliance with Site Requirements. If the residential specialist finds that the residence is not in compliance with a site requirement or requirements outlined in Regulation .05 of this chapter, the residential specialist shall:</text> <paragraph num="(1)"> <text>If the deficiency does not pose an imminent risk to the health, safety, or welfare of an individual served:</text> <paragraph num="(a)"> <text>Give the RRP program director written notice of provisional approval, identifying the deficiency and the time frame, of not more than 30 days, to correct the deficiency; and</text> </paragraph> <paragraph num="(b)"> <text>If necessary, reinspect the residence to determine compliance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the deficiency poses a risk to the health, safety, or welfare of an individual served;</text> <paragraph num="(a)"> <text>Give the RRP program director written notice that the Department intends not to approve the residence, citing the reason for the disapproval, with copies to the:</text> <paragraph num="(i)"> <text>PRP program director; and</text> </paragraph> <paragraph num="(ii)"> <text>Director of the CSA; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Request corrective action within 24 hours;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the deficiency cited under:</text> <paragraph num="(a)"> <text>§B(1) of this regulation is within 30 days:</text> <paragraph num="(i)"> <text>Corrected, issue a certificate of general approval; or</text> </paragraph> <paragraph num="(ii)"> <text>Not corrected, reevaluate the approval status of the residence and provide that information to the Department's designated approval unit for consideration when evaluating the approval status of the RRP; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Section B(2) of this regulation is not corrected within 24 hours, give the RRP program director, with copies to the PRP program director and Director of the CSA, written notice of:</text> <paragraph num="(i)"> <text>The emergency suspension of the approval of the residence, under State Government Article, §10-226, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Hearing rights, as provided in COMAR 10.21.16.11; and</text> </paragraph> <paragraph num="(iii)"> <text>The obligation to relocate residents according to the provisions of §C of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Relocation of Residents. If approval of a residence is suspended under the provisions of §B(3)(b) of this regulation, the RRP director shall relocate residents according to the plan adopted under Regulation .05D of this chapter.</text> </paragraph> <paragraph num="D."> <text>Extension of Approval Status of a Residence. If the residential specialist does not complete a site inspection before an on-site review by the Department's designated approval unit, the Secretary shall maintain the RRP's existing approval status, pending receipt of the residential specialist's determination of approval status of a residence or residences.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Site Requirements."> <paragraph num="A."> <text>General Requirements. The RRP director shall ensure that:</text> <paragraph num="(1)"> <text>All areas of a residence, including storage areas, are safe, clean, and free of hazards and clutter;</text> </paragraph> <paragraph num="(2)"> <text>A residence has:</text> <paragraph num="(a)"> <text>No housing code or zoning violations;</text> </paragraph> <paragraph num="(b)"> <text>Working smoke alarms or smoke detectors that meet local fire codes for residential dwellings;</text> </paragraph> <paragraph num="(c)"> <text>Hot and cold running water and adequate light, heat, and ventilation; and</text> </paragraph> <paragraph num="(d)"> <text>Sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils comparable to those found in the residences of nondisabled individuals;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A resident:</text> <paragraph num="(a)"> <text>Has the resources to purchase or has access to food:</text> <paragraph num="(i)"> <text>For at least three meals per day for 7 days each week; and</text> </paragraph> <paragraph num="(ii)"> <text>That meets the individual's dietary, nutritional, and religious needs;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has the resources to acquire an adequate supply of soap, towels, and toilet tissue;</text> </paragraph> <paragraph num="(c)"> <text>Who self-administers medication, has access to a secure storage area for the individual's medications;</text> </paragraph> <paragraph num="(d)"> <text>Has access to a secure storage area for funds and valuables;</text> </paragraph> <paragraph num="(e)"> <text>Has access to transportation;</text> </paragraph> <paragraph num="(f)"> <text>Has access to a telephone in the residence; and</text> </paragraph> <paragraph num="(g)"> <text>To the extent possible, may use personal possessions and preferences in furnishing and decorating the resident's space; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The following emergency procedures are in place:</text> <paragraph num="(a)"> <text>Posted near the telephone are telephone numbers for the:</text> <paragraph num="(i)"> <text>Fire department, police, ambulance, and poison control center; and</text> </paragraph> <paragraph num="(ii)"> <text>Program's on-call staff; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An emergency evacuation procedure that is explained to and practiced by residents within 10 days of residence and, at a minimum, every 3 months after that.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Bedrooms. The RRP director shall ensure that a bedroom has:</text> <paragraph num="(1)"> <text>A minimum of 70 square feet for a single bedroom and a minimum of 120 square feet for a double bedroom;</text> </paragraph> <paragraph num="(2)"> <text>A door, except for an efficiency apartment;</text> </paragraph> <paragraph num="(3)"> <text>Closet space for each individual in or convenient to each bedroom;</text> </paragraph> <paragraph num="(4)"> <text>Window covering for privacy;</text> </paragraph> <paragraph num="(5)"> <text>A bed with a clean mattress and pillow;</text> </paragraph> <paragraph num="(6)"> <text>At least two sets of linens per individual; and</text> </paragraph> <paragraph num="(7)"> <text>Not more than two residents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Toilet and Bathing Areas. The RRP director shall ensure that:</text> <paragraph num="(1)"> <text>The residence has a minimum of one full bathroom for every four residents;</text> </paragraph> <paragraph num="(2)"> <text>A full bathroom includes at least one toilet, one basin, and one tub or shower connected to hot and cold water;</text> </paragraph> <paragraph num="(3)"> <text>Bathrooms are easily accessible and conveniently located, not more than one floor level from living, dining, and sleeping rooms; and</text> </paragraph> <paragraph num="(4)"> <text>Bathrooms provide for individual privacy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Relocation Plan. Each program shall have a written relocation plan that:</text> <paragraph num="(1)"> <text>Specifies where residents may live temporarily if the residential specialist determines that conditions in the approved residence pose an imminent risk to the health, safety, or welfare of a resident;</text> </paragraph> <paragraph num="(2)"> <text>Is approved by the CSA;</text> </paragraph> <paragraph num="(3)"> <text>Is updated annually; and</text> </paragraph> <paragraph num="(4)"> <text>Is submitted to the residential specialist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Residential Rehabilitation Program Model."> <paragraph num="A."> <text>The RRP director shall organize, maintain, and develop:</text> <paragraph num="(1)"> <text>Policies directed to ensure the provision of flexible services which respond to the current needs of an individual in an RRP; and</text> </paragraph> <paragraph num="(2)"> <text>Services that:</text> <paragraph num="(a)"> <text>Promote the individual's ability to engage and participate in appropriate community activities; and</text> </paragraph> <paragraph num="(b)"> <text>In a supportive environment, enable the individual to develop the daily living skills needed for independent functioning.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The RRP director shall ensure that the residential rehabilitation program:</text> <paragraph num="(1)"> <text>Is located in the community, unless given an exemption by the CSA;</text> </paragraph> <paragraph num="(2)"> <text>Offers a home-like environment; and</text> </paragraph> <paragraph num="(3)"> <text>Provides goal-directed PRP services that facilitate rehabilitation and integration into community life.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Eligibility, Screening, and Enrollment."> <paragraph num="A."> <text>An RRP shall conduct eligibility review, screening, and enrollment according to the provisions of COMAR 10.21.21.04.</text> </paragraph> <paragraph num="B."> <text>If the RRP residence is a group home that is licensed under COMAR 10.21.04, the RRP shall admit residents according to the additional limitations outlined under COMAR 10.21.04.03B and C.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Evaluation and Planning Services."> <paragraph num="A."> <text>Assessment. Within 30 days of initiation of RRP services, staff, in collaboration with the individual, shall complete an RRP assessment that includes:</text> <paragraph num="(1)"> <text>The rehabilitation service requirements noted in the PRP assessment; and</text> </paragraph> <paragraph num="(2)"> <text>An assessment of the individual's:</text> <paragraph num="(a)"> <text>Need for RRP services;</text> </paragraph> <paragraph num="(b)"> <text>Behaviors, if any, that are potentially dangerous to self or others;</text> </paragraph> <paragraph num="(c)"> <text>Ability to perform basic self-care and to maintain personal safety;</text> </paragraph> <paragraph num="(d)"> <text>History, if any, of requiring intermittent intensive levels of support in order to remain in the community; and</text> </paragraph> <paragraph num="(e)"> <text>Need for changing intensity of intervention based on the episodic nature of illness.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Individualized Rehabilitation Plan (IRP).</text> <paragraph num="(1)"> <text>Initial IRP. Within 30 days of initiation of RRP services and based on the assessment in §A of this regulation, staff shall specify in the IRP:</text> <paragraph num="(a)"> <text>RRP goals; and</text> </paragraph> <paragraph num="(b)"> <text>The range of:</text> <paragraph num="(i)"> <text>Frequency of residential services; and</text> </paragraph> <paragraph num="(ii)"> <text>Intensity of staff support, as described in Regulation .09D of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the individual's service needs change, the RRP staff shall:</text> <paragraph num="(a)"> <text>Provide and document in the individual's record the services required by the change;</text> </paragraph> <paragraph num="(b)"> <text>Notify relevant staff of the change initiated; and</text> </paragraph> <paragraph num="(c)"> <text>Incorporate this information in the next IRP review.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>IRP Review. As frequently as necessary, as determined by an individual's rehabilitation coordinator, and at a minimum of every 6 months, the rehabilitation coordinator shall:</text> <paragraph num="(a)"> <text>Review and record in the individual's medical record:</text> <paragraph num="(i)"> <text>The individual's progress toward the accomplishment of previously identified rehabilitation goals;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes, based on a review of the individual's progress; and</text> </paragraph> <paragraph num="(iii)"> <text>Changes in interventions, including staff responsibility;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Communicate promptly the results of the IRP review to:</text> <paragraph num="(i)"> <text>Relevant program staff; and</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, family or significant others designated by the individual, and community mental health programs providing services to the individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Signature of the IRP and Reviews. Staff shall obtain the individual's written or tape-recorded agreement or disagreement with the plan and, in addition, the following shall sign the plan and reviews:</text> <paragraph num="(a)"> <text>The rehabilitation coordinator; and</text> </paragraph> <paragraph num="(b)"> <text>Staff responsible for implementing the plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Evaluation. The RRP director shall ensure that RRP staff document in the individual's PRP record contact notes and, at least monthly, progress summary notes of services, including any change in intensity of staff support, delivered at the RRP.</text> </paragraph> <paragraph num="D."> <text>Documentation. RRP staff shall document the assessment, IRP, contact notes, and progress summary notes for residential services in either:</text> <paragraph num="(1)"> <text>The PRP record; or</text> </paragraph> <paragraph num="(2)"> <text>In documents separate from the PRP record, if the PRP record references the separate documents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Residential Rehabilitation and Support Services Provided."> <text>In addition to the provision of PRP services, the RRP program director shall ensure that:</text> <paragraph num="A."> <text>RRP services support the program model outlined in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="B."> <text>Staff provide an appropriate range of services:</text> <paragraph num="(1)"> <text>Based on the assessment under Regulation .08A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>In a flexible manner, as needed by the individual;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Appropriate staff maintain linkage, as described in COMAR 10.21.21.06F, with a resident who is in a psychiatric inpatient facility or detention center; and</text> </paragraph> <paragraph num="D."> <text>Staff support, based on the program description as referenced in Regulation .03B(1) of this chapter, is provided at the level indicated by the individual's need, as follows:</text> <paragraph num="(1)"> <text>General support, which provides that, at a minimum, staff:</text> <paragraph num="(a)"> <text>Are available, on call, 24 hours per day, 7 days per week; and</text> </paragraph> <paragraph num="(b)"> <text>Have at least one face-to-face contact per individual per week; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Intensive support, which provides that staff are available, on site, for:</text> <paragraph num="(a)"> <text>Daily support for a specific number of individuals; and</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 40 hours per week for up to 24 hours per day, 7 days per week.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Discharge, Suspension, and Discontinuation of Residential Services."> <paragraph num="A."> <text>Discharge Policy. The program director shall:</text> <paragraph num="(1)"> <text>Collaborate with the Administration's administrative services organization (ASO) to:</text> <paragraph num="(a)"> <text>Arrange for discharge from the program when services are no longer authorized by the Administration's ASO; and</text> </paragraph> <paragraph num="(b)"> <text>Discontinue residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain clearly written policies and procedures for:</text> <paragraph num="(a)"> <text>The process for discharge from the program; and</text> </paragraph> <paragraph num="(b)"> <text>Temporary suspension from a residence; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Discontinue residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, including the:</text> <paragraph num="(a)"> <text>Criteria for discontinuation; and</text> </paragraph> <paragraph num="(b)"> <text>Progressive steps and interventions that the program will enact before discontinuation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Collaborative Discharge. When the Administration's ASO, in consultation with the rehabilitation coordinator, determines that services are no longer medically necessary, the rehabilitation coordinator shall follow the provisions for collaborative discharge outlined in COMAR 10.21.21.07B.</text> </paragraph> <paragraph num="C."> <text>Suspension.</text> <paragraph num="(1)"> <text>If an individual's clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, the RRP program director may ask the individual to leave the residence on a temporary basis, as an alternative to the individual's termination from the residence.</text> </paragraph> <paragraph num="(2)"> <text>To implement a suspension identified in §C(1) of this regulation, the RRP program director:</text> <paragraph num="(a)"> <text>In writing, shall inform:</text> <paragraph num="(i)"> <text>The individual of the suspension and the reason for the determination; and</text> </paragraph> <paragraph num="(ii)"> <text>When involved and with proper consent, the CSA and the Administration's ASO of the suspension;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Shall give information on placement alternatives; and</text> </paragraph> <paragraph num="(c)"> <text>May provide temporary housing options.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Program's Recommendation to Discontinue Residential Services. If the program director recommends discontinuing residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, the program director shall:</text> <paragraph num="(1)"> <text>Provide written notice of the discontinuation, according to the provisions of COMAR 10.21.21.07D;</text> </paragraph> <paragraph num="(2)"> <text>When possible, give the individual information about appropriate alternative services;</text> </paragraph> <paragraph num="(3)"> <text>When authorized, arrange for outreach, by PRP staff, to encourage the individual to access appropriate services; and</text> </paragraph> <paragraph num="(4)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="RRP Staff."> <paragraph num="A."> <text>RRP Program Director. The PRP program director shall either:</text> <paragraph num="(1)"> <text>Carry out the RRP program director's duties that are delineated in this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Appoint an RRP program director with the qualifications outlined in COMAR 10.21.21.08C.</text> </paragraph> </paragraph> <paragraph num="B."> <text>RRP Staff. The RRP program director shall ensure the deployment of sufficient staff to carry out the RRP:</text> <paragraph num="(1)"> <text>Model described in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Activities outlined in the individual's IRPs; and</text> </paragraph> <paragraph num="(3)"> <text>Staff support outlined in Regulation .09D of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Quality Management (QM)."> <paragraph num="A."> <text>In addition to the QM requirements in COMAR 10.21.17.10, annually the RRP program director shall complete and document reviews of the RRP's staff support, as described in Regulation .09D of this chapter, to evaluate the relationship between staff deployment and the:</text> <paragraph num="(1)"> <text>Number of:</text> <paragraph num="(a)"> <text>Admissions to inpatient psychiatric facilities;</text> </paragraph> <paragraph num="(b)"> <text>Visits to emergency departments; and</text> </paragraph> <paragraph num="(c)"> <text>Suspensions and terminations; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Results of the program's risk management (RM) analysis conducted under the provisions of COMAR 10.21.17.10C(3).</text> </paragraph> </paragraph> <paragraph num="B."> <text>The RRP program director shall evaluate the results of the interviews conducted by the residential specialist under the provisions of Regulation .04A(1) of this chapter and, when appropriate, modify the RRP services being delivered.</text> </paragraph> <paragraph num="C."> <text>The RRP program director shall notify the CSA director of the results of the analysis conducted under §A(1) of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .12 adopted as an emergency provision effective January 16, 1995 (21:26 Md. R. 2183); adopted permanently effective April 24, 1995 (22:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 30, 1998 (25:24 Md. R. 1774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective October 17, 2011 (38:21 Md. R. 1278)</annotation> </annotations> </chapter> <chapter num="23" heading="Community-Based Fund"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the process for deposits to and disbursements from a community-based fund that is established when a ward is closed at a State inpatient facility.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Mental Hygiene Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Admission” means that an individual is:</text> <paragraph num="(a)"> <text>Taken into observation status on the basis of certification for involuntary admission under Health-General Article, §§10-614 — 10-617, Annotated Code of Maryland, and COMAR 10.21.01.07; or</text> </paragraph> <paragraph num="(b)"> <text>Voluntarily admitted under the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Average annual itemized expenses” means the amount budgeted for institutional services and administrative overhead costs that are appropriated for the facility in the fiscal year in which downsizing occurs.</text> </paragraph> <paragraph num="(4)"> <text>“Core service agency (CSA)” means the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services.</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Director” means the Director of the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Downsizing” means the process by which the Administration analyzes the projected capacity of a State inpatient facility and implements procedures to close a ward or wards.</text> </paragraph> <paragraph num="(8)"> <text>“Fund” means the Mental Hygiene Community-Based Services Fund established according to the requirements of Health-General Article, §10-208, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(10)"> <text>“State inpatient facility” means a facility listed in Health-General Article, §10-406(a), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Planning."> <paragraph num="A."> <text>The Administration shall identify annually the number and size of wards, if any, marked for closure at each State inpatient facility.</text> </paragraph> <paragraph num="B."> <text>The Administration may use State general funds that are appropriated in advance to assist in downsizing.</text> </paragraph> <paragraph num="C."> <text>In planning for the provision of appropriate treatment and support services in the community, if the jurisdictions to which individuals discharged from the closing wards are:</text> <paragraph num="(1)"> <text>Served by a core service agency (CSA) or agencies, the Administration shall collaborate with the appropriate CSA; or</text> </paragraph> <paragraph num="(2)"> <text>Not served by a CSA, the Administration, in collaboration with the local health officer, shall carry out the necessary planning.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Deposits to the Fund."> <paragraph num="A."> <text>When the Administration determines to close a ward or wards of a facility, the Administration shall assure that savings resulting from the downsizing are used as provided under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>In depositing to the Fund, the Administration shall follow the following process:</text> <paragraph num="(1)"> <text>Calculate the net daily cost of maintaining an individual in the facility by:</text> <paragraph num="(a)"> <text>Subtracting from the facility's total general fund appropriation:</text> <paragraph num="(i)"> <text>Average annual itemized expenses for costs that are required to continue to provide care, treatment, and support services;</text> </paragraph> <paragraph num="(ii)"> <text>Cost for new admissions to the facility under Health-General Article, Title 10, Subtitle 6, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Cost for court-ordered evaluations and commitments to the facility under Health-General Article, Title 12, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Dividing the net result under §B(1)(a) of this regulation by the average patient population of the facility, to arrive at the net facility cost per individual per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>According to the planning process under Regulation .03C of this chapter, determine the community cost per individual per day of providing appropriate treatment and mental health support services;</text> </paragraph> <paragraph num="(3)"> <text>Subtract from the facility cost per individual per day yielded under §B(1) of this regulation the community cost per individual per day yielded under §B(2) of this regulation to yield the savings per individual per day;</text> </paragraph> <paragraph num="(4)"> <text>Multiply the savings per individual per day under §B(3) of this regulation by the capacity of the ward or wards closed to arrive at the total savings per day; and</text> </paragraph> <paragraph num="(5)"> <text>For the fiscal year that the ward is closed, deposit to the Fund the prorated amount, based on the total savings per day under §B(4) of this regulation, multiplied by the number of days that the ward is vacated.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disbursements from the Fund."> <paragraph num="A."> <text>The Administration shall ensure that the first priority for disbursements from the Fund is for the care and treatment of individuals discharged from the closed ward or wards.</text> </paragraph> <paragraph num="B."> <text>The Administration may not use the Fund to supplant State general fund resources for existing community services.</text> </paragraph> <paragraph num="C."> <text>Disbursements from the Fund, in excess of the amount required to annualize the cost of care and treatment of individuals discharged from the closed ward or wards, are subject to the State appropriations process.</text> </paragraph> <paragraph num="D."> <text>The Director shall ensure that the Fund is used to provide needed services in the community, including but not limited to:</text> <paragraph num="(1)"> <text>Case management;</text> </paragraph> <paragraph num="(2)"> <text>Crisis services;</text> </paragraph> <paragraph num="(3)"> <text>Outpatient mental health clinic;</text> </paragraph> <paragraph num="(4)"> <text>Psychiatric day treatment;</text> </paragraph> <paragraph num="(5)"> <text>Group home placement;</text> </paragraph> <paragraph num="(6)"> <text>Mobile treatment services;</text> </paragraph> <paragraph num="(7)"> <text>Psychiatric rehabilitation;</text> </paragraph> <paragraph num="(8)"> <text>Residential rehabilitation;</text> </paragraph> <paragraph num="(9)"> <text>Supported employment;</text> </paragraph> <paragraph num="(10)"> <text>Supported living;</text> </paragraph> <paragraph num="(11)"> <text>Therapeutic group homes; and</text> </paragraph> <paragraph num="(12)"> <text>Consumer-operated programs.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Portions of the Fund that are unspent at the end of a fiscal year, and earned interest, shall remain in the Fund to be used for the purposes specified in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reporting."> <paragraph num="A."> <text>On or before January 1 of each year, the Secretary shall prepare a report on the Fund to be submitted to the General Assembly and the Department of Fiscal Services.</text> </paragraph> <paragraph num="B."> <text>The Secretary shall include in the report:</text> <paragraph num="(1)"> <text>The number and capacity of State inpatient facility wards closed during the prior fiscal year;</text> </paragraph> <paragraph num="(2)"> <text>An accounting of:</text> <paragraph num="(a)"> <text>The amount deposited to the Fund according to the methodology outlined under Regulation .04 of this chapter, and</text> </paragraph> <paragraph num="(b)"> <text>All other amounts reallocated from facilities to community programs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An accounting of disbursements from the Fund in accordance with Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>The number and capacity of State inpatient facility wards planned for closure during the current fiscal year.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-208, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 23, 1995 (22:21 Md. R. 1616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 9, 1998 (25:3 Md. R. 145)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective February 9, 1998 (25:3 Md. R. 145)</annotation> </annotations> </chapter> <chapter num="24" heading="Interagency Discharge Planning for Hospitalized Children and Adolescents"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>COMAR 01.04.03 is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Article 49D, §4, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 5, 1997 (24:9 Md. R. 657)</annotation> </annotations> </chapter> <chapter num="25" heading="Fee Schedule — Mental Health Services — Community-Based Programs and Individual Practitioners"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the fees that the Department reimburses for mental health services that are rendered by a provider to an individual who receives Medicaid-reimbursable or State-supported services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="General Reimbursement."> <paragraph num="A."> <text>The Department shall reimburse the lower of the amount billed or the fee established under this chapter, after the application of an individual's copayment, based on the ability-to-pay determination according to Regulation .03 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department may reimburse for non-Medicaid-reimbursable mental health services to the extent that State resources permit.</text> </paragraph> <paragraph num="C."> <text>According to the provisions of this chapter, the Department shall reimburse a mental health services provider:</text> <paragraph num="(1)"> <text>That is:</text> <paragraph num="(a)"> <text>A community-based mental health program that is approved by the Department; or</text> </paragraph> <paragraph num="(b)"> <text>An appropriately credentialed individual practitioner who contracts with the Department's Medical Assistance Program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For specific services that are delivered to:</text> <paragraph num="(a)"> <text>Medicaid recipients; or</text> </paragraph> <paragraph num="(b)"> <text>Individuals for whom, because of the severity of their mental illness and their financial need, the cost of mental health services is subsidized, in whole or in part, by State general funds for services not reimbursed under a grant or a contract.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>This chapter does not establish fees for services that are provided by:</text> <paragraph num="(1)"> <text>A federally qualified health center;</text> </paragraph> <paragraph num="(2)"> <text>An inpatient facility regulated by the Health Services Cost Review Commission, to an inpatient or resident of the facility; or</text> </paragraph> <paragraph num="(3)"> <text>A home health agency licensed under COMAR 10.09.04.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The mental health service provider shall bill services using:</text> <paragraph num="(1)"> <text>The procedural terminology codes contained in the most current Physician's Current Procedural Terminology (CPT) manual published by the American Medical Association and incorporated by reference in COMAR 10.09.09.07D; and</text> </paragraph> <paragraph num="(2)"> <text>If there is no current CPT code for the service, a customized code published by the Administration.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The mental health service provider, by submitting a claim for reimbursement for service, certifies that the service is medically necessary, has been delivered and meets the description and intent of the CPT code which is contained on its claim for reimbursement.</text> </paragraph> <paragraph num="G."> <text>Medicare Recipients.</text> <paragraph num="(1)"> <text>If a provider renders services to individuals who are Medicare recipients, the provider shall comply with all federal Medicare requirements.</text> </paragraph> <paragraph num="(2)"> <text>If a provider does not comply with all Medicare requirements, the provider may not seek reimbursement by the PMHS.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17, COMAR 10.63.01.02, and this regulation.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Ability-to-pay schedule” means the schedule adopted, according to the provisions of Health-General Article, Title 16, Subtitle 2, Annotated Code of Maryland, by the Secretary to evaluate and establish the extent of a consumer's ability to pay for services rendered.</text> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Behavioral Health Administration.</text> </paragraph> <paragraph num="(2-1)"> <text>“Assertive Community Treatment Program (ACT)” means an evidence-based practice program approved by the Administration under its regulations.</text> </paragraph> <paragraph num="(3)"> <text>“Core service agency (CSA)” has the meaning stated in COMAR 10.63.01.02.</text> </paragraph> <paragraph num="(3-1)"> <text>“Day habilitation” has the meaning stated in COMAR 10.09.46.</text> </paragraph> <paragraph num="(3-2)"> <text>“Emergency department” means an organized hospital-based facility that provides unscheduled episodic services, 24 hours per day, 7 days per week, to individuals who present for immediate medical attention.</text> </paragraph> <paragraph num="(4)"> <text>Emergency Service.</text> <paragraph num="(a)"> <text>“Emergency service” means a service that is provided to an individual who presents a danger to the life or safety of the individual or another.</text> </paragraph> <paragraph num="(b)"> <text>“Emergency service” does not include a residential or mobile crisis service.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Enhanced support” means short-term, in-home services, in addition to other services to an individual, provided by a program to support the individual to remain in the community:</text> <paragraph num="(a)"> <text>For mobile treatment services:</text> <paragraph num="(i)"> <text>Under COMAR 10.21.19 if approved; and</text> </paragraph> <paragraph num="(ii)"> <text>Under COMAR 10.63.03.04 if licensed;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For adult psychiatric rehabilitation services:</text> <paragraph num="(i)"> <text>Under COMAR 10.21.21 if approved; and</text> </paragraph> <paragraph num="(ii)"> <text>Under COMAR 10.63.03.09 if licensed; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For outpatient mental health services;</text> <paragraph num="(i)"> <text>Under COMAR 10.21.20 if approved; and</text> </paragraph> <paragraph num="(ii)"> <text>Under COMAR 10.63.03.05 if licensed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5-1)"> <text>“Evidence-based practice (EBP)” is an Administration-approved practice that applies to certain clinical or rehabilitative interventions provided by public mental health service providers.</text> </paragraph> <paragraph num="(5-2)"> <text>“Family psychoeducation” is an evidence-based practice approved by the Administration under its regulations.</text> </paragraph> <paragraph num="(6)"> <text>“Fee” means the dollar amount, established by the Secretary, that a provider may charge an individual who receives services under this chapter for a unit of service, before the application of an ability-to-pay determination.</text> </paragraph> <paragraph num="(7)"> <text>“Individual practitioner” means:</text> <paragraph num="(a)"> <text>A marriage and family therapist who is licensed and legally authorized to practice clinical marriage and family therapy in the state in which the service is rendered;</text> </paragraph> <paragraph num="(b)"> <text>A nurse psychotherapist who is:</text> <paragraph num="(i)"> <text>Licensed and legally authorized to practice as a nurse psychotherapist in the state in which the service is rendered; and</text> </paragraph> <paragraph num="(ii)"> <text>Certified by the Maryland Board of Nursing or an equivalent board of nursing in another state as a nurse psychotherapist, and demonstrates, by training and experience, the competency to provide the mental health services;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A certified registered nurse practitioner psychiatric mental health (CRNP-PMH) who is:</text> <paragraph num="(i)"> <text>Licensed and legally authorized to practice as a certified registered nurse practitioner — psychiatric in the state in which the service is rendered to perform independently the services set forth in COMAR 10.27.07; and</text> </paragraph> <paragraph num="(ii)"> <text>Certified by the Maryland Board of Nursing or an equivalent board of nursing in another state as a certified registered nurse practitioner with a specialty in psychiatry pursuant to COMAR 10.27.07 and demonstrates, by training and experience, the competency to provide the mental health services;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>An occupational therapist who:</text> <paragraph num="(i)"> <text>Is licensed and legally authorized to practice as an occupational therapist in the state in which the service is rendered, and</text> </paragraph> <paragraph num="(ii)"> <text>Demonstrates, by training and experience, the competency to provide mental health services;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A physician who:</text> <paragraph num="(i)"> <text>Is licensed and legally authorized to practice as a physician in the state in which the service is rendered, and</text> </paragraph> <paragraph num="(ii)"> <text>Demonstrates, by training and experience, the competency to provide mental health services;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>A professional counselor who is licensed and legally authorized to practice as a clinical professional counselor in the state in which the service is rendered;</text> </paragraph> <paragraph num="(g)"> <text>A psychologist who:</text> <paragraph num="(i)"> <text>Is licensed and legally authorized to practice as a psychologist in the state in which the service is rendered, and</text> </paragraph> <paragraph num="(ii)"> <text>Demonstrates, by training and experience, the competency to provide mental health services; or</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>A social worker who is licensed and legally authorized to practice as a clinical social worker in the state in which the service is rendered.</text> </paragraph> </paragraph> <paragraph num="(7-1)"> <text>“Intensive outpatient services” means services that are delivered to an individual by a multidisciplinary team for a minimum of 3 hours of therapeutic activities, including at least two group therapies.</text> </paragraph> <paragraph num="(7-2)"> <text>“Level I” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in:</text> <paragraph num="(a)"> <text>For individuals receiving residential habilitation services, COMAR 10.09.46.07D(2);</text> </paragraph> <paragraph num="(b)"> <text>For individuals receiving day habilitation services, COMAR 10.09.46.08F(2); and</text> </paragraph> <paragraph num="(c)"> <text>For individuals receiving supported employment services, COMAR 10.09.46.09C(2).</text> </paragraph> </paragraph> <paragraph num="(7-3)"> <text>“Level II” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in:</text> <paragraph num="(a)"> <text>For individuals receiving residential habilitation services, COMAR 10.09.46.07D(3);</text> </paragraph> <paragraph num="(b)"> <text>For individuals receiving day habilitation services, COMAR 10.09.46.08F(3); and</text> </paragraph> <paragraph num="(c)"> <text>For individuals receiving supported employment services, COMAR 10.09.46.09C(3).</text> </paragraph> </paragraph> <paragraph num="(7-4)"> <text>“Level III” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in:</text> <paragraph num="(a)"> <text>For individuals receiving residential habilitation services, COMAR 10.09.46.07D(4);</text> </paragraph> <paragraph num="(b)"> <text>For individuals receiving day habilitation services, COMAR 10.09.46.08F(4); and</text> </paragraph> <paragraph num="(c)"> <text>For individuals receiving supported employment services, COMAR 10.09.46.09C(4).</text> </paragraph> </paragraph> <paragraph num="(7-5)"> <text>“Local behavioral health authority (LBHA)” has the meaning stated in COMAR 10.63.01.02.</text> </paragraph> <paragraph num="(8)"> <text>Mental Health Program.</text> <paragraph num="(a)"> <text>“Mental health program” means a program that provides a plan of mental health treatment or mental health rehabilitation, consisting of various therapeutic modalities, that is:</text> <paragraph num="(i)"> <text>Approved by the Department under this subtitle or COMAR 10.09 to be eligible to receive State or federal funds; and</text> </paragraph> <paragraph num="(ii)"> <text>Provided in the community.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Mental health program” includes:</text> <paragraph num="(i)"> <text>Non-hospital-based partial hospitalization (psychiatric day treatment) services under COMAR 10.21.02 if approved, and COMAR 10.63.03.08 if licensed;</text> </paragraph> <paragraph num="(ii)"> <text>Therapeutic nursery programs under COMAR 10.21.18;</text> </paragraph> <paragraph num="(iii)"> <text>Mobile treatment services under COMAR 10.21.19 if approved, and COMAR 10.63.03.04 if licensed;</text> </paragraph> <paragraph num="(iv)"> <text>Outpatient mental health clinic (OMHC) services under COMAR 10.21.20 if approved, and COMAR 10.63.03.05 if licensed;</text> </paragraph> <paragraph num="(v)"> <text>Psychiatric rehabilitation programs for adults under COMAR 10.21.21 if approved, and COMAR 10.63.03.09 if licensed, including supported living services;</text> </paragraph> <paragraph num="(vi)"> <text>Residential rehabilitation programs under COMAR 10.21.22 if approved, and COMAR 10.63.04.05 if licensed;</text> </paragraph> <paragraph num="(vii)"> <text>Home health services under COMAR 10.09.04;</text> </paragraph> <paragraph num="(viii)"> <text>Supported employment programs under COMAR 10.21.28 if approved, and COMAR 10.63.03.16 if licensed;</text> </paragraph> <paragraph num="(ix)"> <text>Respite care programs under COMAR 10.21.27 if approved, and COMAR 10.63.03.15 if licensed;</text> </paragraph> <paragraph num="(x)"> <text>Residential crisis services programs under COMAR 10.21.26 if approved, and COMAR 10.63.04.04 if licensed; and</text> </paragraph> <paragraph num="(xi)"> <text>Therapeutic and psychiatric rehabilitation services for minors under COMAR 10.21.29 if approved, and COMAR 10.63.03.10 if licensed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>Mobile Treatment.</text> <paragraph num="(a)"> <text>“Mobile treatment” means a program approved under COMAR 10.21.19, or licensed under COMAR 10.63.03.04.</text> </paragraph> <paragraph num="(b)"> <text>“Mobile treatment” does not include transporting an individual to a program site to receive services.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Off-Site.</text> <paragraph num="(a)"> <text>“Off-site” means a location, other than a site defined in §B(11) of this regulation, to which mental health program staff travels to provide services to an individual.</text> </paragraph> <paragraph num="(b)"> <text>“Off-site” includes, with respect to psychiatric rehabilitation program services, those services delivered to an individual:</text> <paragraph num="(i)"> <text>In the individual's home, including a residential rehabilitation program residence;</text> </paragraph> <paragraph num="(ii)"> <text>At a job site; or</text> </paragraph> <paragraph num="(iii)"> <text>At another community location appropriate to the individual's needs.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Off-site” does not include:</text> <paragraph num="(i)"> <text>A juvenile detention center; or</text> </paragraph> <paragraph num="(ii)"> <text>Any facility or group home that is licensed to provide rehabilitative or therapeutic services, or living skills.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“On-site” means a mental health program facility or other site to which a program has access and at which the program regularly delivers services to individuals who come to the site for the services.</text> </paragraph> <paragraph num="(11-1)"> <text>Other Mental Health Professional.</text> <paragraph num="(a)"> <text>“Other mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service.</text> </paragraph> <paragraph num="(b)"> <text>“Other mental health professional” includes a:</text> <paragraph num="(i)"> <text>Licensed certified social worker — clinical;</text> </paragraph> <paragraph num="(ii)"> <text>Nurse psychotherapist;</text> </paragraph> <paragraph num="(iii)"> <text>Licensed clinical professional counselor;</text> </paragraph> <paragraph num="(iv)"> <text>Licensed clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(v)"> <text>Certified registered nurse practitioner — psychiatric mental health (CRNP-PMH).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Outpatient mental health clinic (OMHC)” means a program approved under COMAR 10.21.20 or licensed under COMAR 10.63.03.05.</text> </paragraph> <paragraph num="(13)"> <text>“Partial hospitalization program” means a program approved under COMAR 10.21.02 or licensed under COMAR 10.63.03.08.</text> </paragraph> <paragraph num="(14)"> <text>“Program” means a mental health program as defined in §B(8) of this regulation.</text> </paragraph> <paragraph num="(15)"> <text>“Provider” means:</text> <paragraph num="(a)"> <text>A community-based mental health program as defined in §B(8) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>An individual practitioner as defined in §B(7) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Psychiatric rehabilitation program for adults (PRP)” means a program approved under COMAR 10.21.21 or licensed under COMAR 10.63.03.09.</text> </paragraph> <paragraph num="(16-1)"> <text>“Residential crisis services (RCS)” means a program approved under COMAR 10.21.26 or licensed under COMAR 10.63.04.04.</text> </paragraph> <paragraph num="(16-2)"> <text>“Residential habilitation” has the meaning stated in COMAR 10.09.46.</text> </paragraph> <paragraph num="(17)"> <text>“Residential rehabilitation program (RRP)” means a program approved under COMAR 10.21.22 or licensed under COMAR 10.63.04.05.</text> </paragraph> <paragraph num="(17-1)"> <text>“Respite care” means services that are approved under COMAR 10.21.27 or licensed under COMAR 10.63.03.15</text> </paragraph> <paragraph num="(18)"> <text>“Secretary” means the Secretary of Health</text> </paragraph> <paragraph num="(19)"> <text>“Serious emotional disturbance” means a condition that is:</text> <paragraph num="(a)"> <text>Manifest in an individual younger than 18 years old;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosed according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary, excluding the following, unless it coexists with a diagnosable psychiatric disorder:</text> <paragraph num="(i)"> <text>Developmental disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Substance abuse; and</text> </paragraph> <paragraph num="(iii)"> <text>Disorder classified under the “V” code; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Characterized by a functional impairment that substantially interferes with or limits the child's role or functioning in the family, school, or community activities, including the following:</text> <paragraph num="(i)"> <text>Inability to achieve or maintain one or more developmentally appropriate social, behavioral communicative, or adaptive skills; or</text> </paragraph> <paragraph num="(ii)"> <text>Episodic, recurrent, and continuous functional impairments.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Serious and persistent mental disorder” means a disorder that is:</text> <paragraph num="(a)"> <text>Manifest in an individual 18 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosed, according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary, as:</text> <paragraph num="(i)"> <text>Schizophrenic disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Major affective disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Other psychotic disorder; or</text> </paragraph> <paragraph num="(iv)"> <text>Borderline or schizotypal personality disorders, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Characterized by impaired role functioning, on a continuing or intermittent basis, for at least 2 years, including at least three of the following:</text> <paragraph num="(i)"> <text>Inability to maintain independent employment;</text> </paragraph> <paragraph num="(ii)"> <text>Social behavior that results in intervention by the mental health system;</text> </paragraph> <paragraph num="(iii)"> <text>Inability, due to cognitive disorganization, to procure financial assistance to support living in the community;</text> </paragraph> <paragraph num="(iv)"> <text>Severe inability to establish or maintain a personal social support system;</text> </paragraph> <paragraph num="(v)"> <text>Need for assistance with basic living skills.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Therapeutic and psychiatric rehabilitation services for minors” means a program approved under COMAR 10.21.29 or licensed under COMAR 10.63.03.10.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="General Reimbursement Conditions."> <paragraph num="A."> <text>Claims Submission. In order to be reimbursed by the Department, an approved provider shall submit a claim when the provider has:</text> <paragraph num="(1)"> <text>Obtained authorization to provide the services for which the claim is being submitted;</text> </paragraph> <paragraph num="(2)"> <text>Delivered the service;</text> </paragraph> <paragraph num="(3)"> <text>Documented provision of service as required; and</text> </paragraph> <paragraph num="(4)"> <text>Complied with any regulatory preconditions for the delivery of the service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Claims Retraction. The Department may retract any payments made to any PMHS provider for paid claims if an audit indicates that:</text> <paragraph num="(1)"> <text>The services were not provided;</text> </paragraph> <paragraph num="(2)"> <text>The services were not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>There is no documentation that the services were provided;</text> </paragraph> <paragraph num="(4)"> <text>The precondition for the delivery of the service was not met; or</text> </paragraph> <paragraph num="(5)"> <text>The provider failed to comply with §H of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department retracts funds from a provider under §B of this regulation, within 30 days following the retraction the Department shall provide notice and an opportunity for a hearing.</text> </paragraph> <paragraph num="D."> <text>Limitations.</text> <paragraph num="(1)"> <text>The Department shall reimburse, for services delivered on the same service date for the same individual, an outpatient mental health center (OMHC) for a maximum of two therapy sessions subject to the following conditions:</text> <paragraph num="(a)"> <text>Only one may be an individual therapy session;</text> </paragraph> <paragraph num="(b)"> <text>Only one may be a group therapy session; and</text> </paragraph> <paragraph num="(c)"> <text>Only one may be a family therapy session, either with or without the individual.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may not reimburse an OMHC for the following services delivered to the same individual on the same service date:</text> <paragraph num="(a)"> <text>Individual therapy with medication management session, and medication management session;</text> </paragraph> <paragraph num="(b)"> <text>Diagnostic interview or assessment, and a treatment planning session; and</text> </paragraph> <paragraph num="(c)"> <text>A diagnostic interview or assessment, and a therapy session.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For all other providers, the Department shall reimburse for only one service per service date.</text> </paragraph> <paragraph num="(4)"> <text>Limitations Exception. The Department may provide an exception to the limitation rule on outpatient services if the ASO finds that the service:</text> <paragraph num="(a)"> <text>Is medically necessary;</text> </paragraph> <paragraph num="(b)"> <text>Is not duplicative; and</text> </paragraph> <paragraph num="(c)"> <text>Has been preauthorized.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall reimburse Psychiatric Rehabilitation Program services provided to a child residing in a therapeutic group home, as defined in COMAR 10.21.07 when the TGH certifies that its negotiated rate does not include payment for the PRP services.</text> </paragraph> <paragraph num="F."> <text>The Department may not reimburse outpatient mental health services provided to an individual when the individual is in a hospital or residential treatment center.</text> </paragraph> <paragraph num="G."> <text>The Department may not reimburse PRP providers until the PRP has met the minimum service encounters as defined in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="H."> <text>For individual practitioners, when services are preauthorized, the following documentation is required before submitting for payment for services rendered:</text> <paragraph num="(1)"> <text>For each individual served, the medical record, which shall include the following documentation:</text> <paragraph num="(a)"> <text>A signed consent to treatment;</text> </paragraph> <paragraph num="(b)"> <text>A comprehensive assessment that includes the:</text> <paragraph num="(i)"> <text>Individual or family’s presenting problem;</text> </paragraph> <paragraph num="(ii)"> <text>Individual or family’s history;</text> </paragraph> <paragraph num="(iii)"> <text>Individual’s diagnosis; and</text> </paragraph> <paragraph num="(iv)"> <text>Rationale for the diagnosis; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An individualized treatment plan that includes the:</text> <paragraph num="(i)"> <text>Problems, needs, strengths, and goals that are measurable;</text> </paragraph> <paragraph num="(ii)"> <text>Interventions that are medically necessary; and</text> </paragraph> <paragraph num="(iii)"> <text>Signatures of the individual, or if the individual is a minor, the guardian, and the treating mental health professional; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Progress notes for each face-to-face contact including:</text> <paragraph num="(a)"> <text>Date of service;</text> </paragraph> <paragraph num="(b)"> <text>Start time and end time;</text> </paragraph> <paragraph num="(c)"> <text>Location;</text> </paragraph> <paragraph num="(d)"> <text>Summary of interventions provided; and</text> </paragraph> <paragraph num="(e)"> <text>The treating mental health professional’s signature and date of service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Services rendered by an individual practitioner may only be reimbursed for the licensed mental health professionals authorized by the practice board to diagnose and treat psychiatric disorders as identified in this chapter of regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-2" heading="Supplemental Rates."> <text>Providers who billed for services rendered from July 1, 2013 until the effective date of these regulations may resubmit their claims and be reimbursed for these services as set forth in Regulations .05 — .12 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Ability to Pay."> <paragraph num="A."> <text>Except if an individual is a Medicaid recipient:</text> <paragraph num="(1)"> <text>A provider shall provide to the Administration's designee the information needed to assess an individual's ability to pay;</text> </paragraph> <paragraph num="(2)"> <text>The Administration's designee shall assess the individual's ability to pay and determine the required copayment; and</text> </paragraph> <paragraph num="(3)"> <text>The provider shall make collections of the copayment according to the requirements in Health-General Article, §§16-201 — 16-204, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall furnish to a provider, on request, an ability-to-pay schedule, including periodic updates.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Fee Schedule — Treatment Services — Diagnosis and Therapy."> <paragraph num="A."> <text>Diagnostic Interview. The Department shall reimburse a provider for a face-to-face diagnostic interview, as follows:</text> <paragraph num="(1)"> <text>For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents:</text> <paragraph num="(a)"> <text>OMHC ... $190.23;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $151.68;</text> </paragraph> <paragraph num="(c)"> <text>Psychologist ... $121.08;</text> </paragraph> <paragraph num="(d)"> <text>Other mental health professionals ... $106.01;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an adult:</text> <paragraph num="(a)"> <text>OMHC ... $170.32;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $151.68;</text> </paragraph> <paragraph num="(c)"> <text>Psychologist ... $121.08;</text> </paragraph> <paragraph num="(d)"> <text>Other mental health professional ... $106.01.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Individual Therapy. The Department shall reimburse a provider for an individual therapy session, as follows:</text> <paragraph num="(1)"> <text>For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents:</text> <paragraph num="(a)"> <text>For 30 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $59.19;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $50.05;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $40.09;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $34.98;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For 20 — 30 minutes, with biofeedback training:</text> <paragraph num="(i)"> <text>OMHC ... $50.05;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $50.05;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $40.09;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $34.98;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For 45 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $105.20;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $90.94;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $72.65;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $63.77;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For 45 — 50 minutes, with biofeedback training:</text> <paragraph num="(i)"> <text>OMHC ... $90.94;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $90.94;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $72.65;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $63.77;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For 60 minutes in an OMHC ... $105.20;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an adult:</text> <paragraph num="(a)"> <text>For 30 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $50.05;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $50.05;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $40.09;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $34.98;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For 20 — 30 minutes, with biofeedback training:</text> <paragraph num="(i)"> <text>OMHC ... $50.05;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $50.05;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $40.09;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $34.98;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For 45 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $90.94;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $90.94;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $72.65;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $63.77;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For 45 — 50 minutes, with biofeedback training:</text> <paragraph num="(i)"> <text>OMHC ... $90.94;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $90.94;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $72.65;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $63.77;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For 60 minutes in an OMHC ... $90.94.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Family Therapy. The Department shall reimburse a provider for a family therapy session, as follows:</text> <paragraph num="(1)"> <text>When the identified patient is a child or adolescent and the service is rendered by a provider with demonstrated competency to provide mental health services to children or adolescents:</text> <paragraph num="(a)"> <text>Without the identified patient:</text> <paragraph num="(i)"> <text>OMHC ... $104.13;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $85.02;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $69.96;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $53.81;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>With the identified patient, for 20 — 30 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $58.65;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $58.65;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $46.82;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $41.17;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>With the identified patient, for 45 — 60 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $107.62;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $94.71;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $76.41;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $65.64;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the identified patient is an adult:</text> <paragraph num="(a)"> <text>Without the identified patient for 45 — 60:</text> <paragraph num="(i)"> <text>OMHC ... $90.14;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $85.02;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $69.96;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $53.81;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>With the identified patient, for 45 — 60 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $94.71;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $94.71;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $76.41;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $65.64.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Group Therapy. The Department shall reimburse a provider for each individual, up to a maximum of 10, in a group therapy session as follows:</text> <paragraph num="(1)"> <text>When the identified patient is a child or adolescent and the service is rendered by a provider with demonstrated competency to provide mental health services to children or adolescents:</text> <paragraph num="(a)"> <text>For 45 — 60 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $40.90;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $24.75;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $24.75;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $24.75;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For more than 75 minutes in an OMHC ... $50.58;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the identified patient is an adult:</text> <paragraph num="(a)"> <text>For 45 — 60 minutes:</text> <paragraph num="(i)"> <text>OMHC ... $38.74;</text> </paragraph> <paragraph num="(ii)"> <text>Physician ... $24.75;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologist ... $24.75;</text> </paragraph> <paragraph num="(iv)"> <text>Other mental health professional ... $24.75;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For more than 75 minutes in an OMHC ... $50.58.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fee Schedule — Additional Treatment Services."> <paragraph num="A."> <text>Psychological Testing. The Department shall reimburse a psychologist for conducting psychological testing, up to a maximum of 8 hours per year per individual as follows:</text> <paragraph num="(1)"> <text>OMHC psychologist ... $99.02 per hour;</text> </paragraph> <paragraph num="(2)"> <text>Other psychologist ... $99.02 per hour;</text> </paragraph> <paragraph num="(3)"> <text>OMHC psychologist associate ... $27.55 per hour;</text> </paragraph> <paragraph num="(4)"> <text>Other psychologist associate ... $27.55 per hour.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Occupational Therapy. The Department shall reimburse an occupational therapist for providing services, as follows:</text> <paragraph num="(1)"> <text>To an individual, payable in 15-minute increments, for face-to-face:</text> <paragraph num="(a)"> <text>Therapeutic activities ... $11.83 per 15 minutes;</text> </paragraph> <paragraph num="(b)"> <text>Self-care, home management training ... $11.83 per 15 minutes;</text> </paragraph> <paragraph num="(c)"> <text>Community and work reintegration ... $11.83 per 15 minutes;</text> </paragraph> <paragraph num="(d)"> <text>Development of cognitive skills ... $11.83 per 15 minutes;</text> </paragraph> <paragraph num="(e)"> <text>Occupational therapy evaluation and re-evaluation ... $15.07 per 15 minutes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For each individual, up to a maximum of 10, in a group therapy session of a minimum of 60 minutes ... $18.30.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physician Services. The Department shall reimburse for services rendered to a child, adolescent, or adult, by an appropriately privileged physician or certified registered nurse practitioner — psychiatric only, as follows:</text> <paragraph num="(1)"> <text>The patient's primary care physician in an inpatient or partial hospital setting:</text> <paragraph num="(a)"> <text>Initial care:</text> <paragraph num="(i)"> <text>For a minimum of 30 minutes ... $108.43;</text> </paragraph> <paragraph num="(ii)"> <text>For a minimum of 50 minutes ... $147.19;</text> </paragraph> <paragraph num="(iii)"> <text>For a minimum of 70 minutes ... $216.47;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Subsequent care:</text> <paragraph num="(i)"> <text>For a minimum of 15 minutes ... $41.71;</text> </paragraph> <paragraph num="(ii)"> <text>For a minimum of 25 minutes ... $76.73;</text> </paragraph> <paragraph num="(iii)"> <text>For a minimum of 35 minutes ... $110.63;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Discharge day management:</text> <paragraph num="(i)"> <text>For 30 minutes or less ... $77.68;</text> </paragraph> <paragraph num="(ii)"> <text>For more than 30 minutes ... $114.63;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For discharge data submission ... $21.53;</text> </paragraph> <paragraph num="(e)"> <text>For individual therapy, in an inpatient setting:</text> <paragraph num="(i)"> <text>For 30 minutes ... $43.78;</text> </paragraph> <paragraph num="(ii)"> <text>For 45 minutes ... $82.30;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The patient's primary certified registered nurse practitioner — psychiatric, in an inpatient or partial hospital setting:</text> <paragraph num="(a)"> <text>Initial care:</text> <paragraph num="(i)"> <text>For a minimum of 30 minutes ... $108.43;</text> </paragraph> <paragraph num="(ii)"> <text>For a minimum of 50 minutes ... $147.19;</text> </paragraph> <paragraph num="(iii)"> <text>For a minimum of 70 minutes ... $216.47;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Subsequent care:</text> <paragraph num="(i)"> <text>For a minimum of 15 minutes ... $41.71;</text> </paragraph> <paragraph num="(ii)"> <text>For a minimum of 25 minutes ... $76.73;</text> </paragraph> <paragraph num="(iii)"> <text>For a minimum of 35 minutes ... $110.63;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Discharge day management:</text> <paragraph num="(i)"> <text>For 30 minutes or less ... $77.68;</text> </paragraph> <paragraph num="(ii)"> <text>For more than 30 minutes ... $114.63;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For individual therapy, in an inpatient setting:</text> <paragraph num="(i)"> <text>For 30 minutes ... $30.65;</text> </paragraph> <paragraph num="(ii)"> <text>For 45 minutes ... $57.61;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For electroconvulsive therapy, in an inpatient setting:</text> <paragraph num="(a)"> <text>Including monitoring ... $98.39;</text> </paragraph> <paragraph num="(b)"> <text>Anesthesia ... $98.27;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A consultant physician, or a consultant certified registered nurse practitioner — psychiatric, in an inpatient or partial hospital setting, initial consult, for a minimum of:</text> <paragraph num="(a)"> <text>20 minutes ... $51.66;</text> </paragraph> <paragraph num="(b)"> <text>40 minutes ... $79.60;</text> </paragraph> <paragraph num="(c)"> <text>55 minutes ... $121.30;</text> </paragraph> <paragraph num="(d)"> <text>80 minutes ... $174.86;</text> </paragraph> <paragraph num="(e)"> <text>110 minutes ... $217.80;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A consultant physician or a consultant certified registered nurse practitioner — psychiatric, in an outpatient setting:</text> <paragraph num="(a)"> <text>For a minimum of 15 minutes ... $51.49;</text> </paragraph> <paragraph num="(b)"> <text>For a minimum of 30 minutes ... $96.74;</text> </paragraph> <paragraph num="(c)"> <text>For a minimum of 40 minutes ... $131.91;</text> </paragraph> <paragraph num="(d)"> <text>For a minimum of 60 minutes ... $194.98;</text> </paragraph> <paragraph num="(e)"> <text>For a minimum of 80 minutes ... $237.73;</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Fee Schedule — Special OMHC Services."> <paragraph num="A."> <text>Treatment Planning. The Department shall reimburse an OMHC for providing an OMHC-enrolled individual with one face-to-face treatment planning meeting every 6 months, at the rate of $82.87 per planning meeting.</text> </paragraph> <paragraph num="B."> <text>Multifamily Group Therapy. The Department shall reimburse an OMHC for providing multifamily group therapy, with the identified patient, for families of:</text> <paragraph num="(1)"> <text>Children and adolescents, for 45 — 60 minutes, with the child present ... $41.98 per family;</text> </paragraph> <paragraph num="(2)"> <text>Children and adolescents, for 20 — 30 minutes, with the child present ... $38.55 per family;</text> </paragraph> <paragraph num="(3)"> <text>Adults, for 45 — 60 minutes, with the adult present ... $39.83 per family;</text> </paragraph> <paragraph num="(4)"> <text>Adults, for 20 — 30 minutes, with the adult present ... $35.75 per family;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Family Psychoeducation. The Department shall reimburse a provider, when the provider has been approved by the Administration to provide evidence-based services, for a family psychoeducation session with or without the identified adult, at a rate of $53.81 per family.</text> </paragraph> <paragraph num="D."> <text>Prolonged Services. The Department shall reimburse an OMHC for providing, on-site, prolonged services, face-to-face with the identified patient, as follows:</text> <paragraph num="(1)"> <text>For 30 — 74 minutes ... $106.79;</text> </paragraph> <paragraph num="(2)"> <text>For an additional period of 30 minutes ... $104.10.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Venipuncture and Injection. The Department shall reimburse an OMHC for providing:</text> <paragraph num="(1)"> <text>Routine venipuncture ... $14.94;</text> </paragraph> <paragraph num="(2)"> <text>Therapeutic injection ... $14.94.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Intensive Outpatient Services. The Department shall reimburse an OMHC for providing intensive outpatient services, when the services are delivered by a multidisciplinary team for a minimum of 3 hours of therapeutic activities, including needed physician services and at least two group therapies, as follows:</text> <paragraph num="(1)"> <text>For children or adolescents ... $154.17 per day;</text> </paragraph> <paragraph num="(2)"> <text>For adults ... $129.69 per day.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Discharge Data Submission. The Department shall reimburse an OMHC $21.53 for discharge data submission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Fee Schedule — Treatment Services — Programs."> <paragraph num="A."> <text>Therapeutic Nursery Programs. The Department shall reimburse a program approved under COMAR 10.21.18 to provide therapeutic nursery services to eligible children, younger than 5 years old, at a rate of $42.20 per day, for a minimum of 3 days per week, 3 hours per day.</text> </paragraph> <paragraph num="B."> <text>Mobile Treatment Services. The Department shall reimburse a program for mobile treatment services delivered to an individual:</text> <paragraph num="(1)"> <text>For a minimum of four face-to-face services, and according to a treatment plan that outlines the expected type and frequency of services;</text> </paragraph> <paragraph num="(2)"> <text>At the rate of:</text> <paragraph num="(a)"> <text>$839.45 per month; or</text> </paragraph> <paragraph num="(b)"> <text>If the individual is a Medicare recipient, $643.58 per month, if the program has:</text> <paragraph num="(i)"> <text>Delivered services according to the provision of §A(1) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Billed applicable Medicare reimbursed services;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For enhanced support, when the need for short-term one-to-one support is documented and approved by the Administration or its designee:</text> <paragraph num="(a)"> <text>At the rate of $12.91 per hour;</text> </paragraph> <paragraph num="(b)"> <text>Up to a maximum of $129.10 per day;</text> </paragraph> <paragraph num="(c)"> <text>Not to exceed 30 days per calendar year.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For evidence-based programs, assertive community treatment (ACT), at the rate of:</text> <paragraph num="(a)"> <text>For Medicaid recipients and other individuals meeting eligibility criteria for uninsured, $1,183.34 per month; or</text> </paragraph> <paragraph num="(b)"> <text>If the individual has Medicare only, $1,049.31 per month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Partial Hospitalization. For programs approved under COMAR 10.21.02 or licensed under COMAR 10.63.03.08, the Department shall reimburse:</text> <paragraph num="(1)"> <text>A non-hospital-based partial hospitalization (psychiatric day treatment) program, for services provided to an eligible Medicaid recipient:</text> <paragraph num="(a)"> <text>For a full day, a minimum of 6.5 hours of therapeutic activities per day ... $203.68 per day;</text> </paragraph> <paragraph num="(b)"> <text>For a half day, or intensive, outpatient services, when the services are delivered by a multidisciplinary team, for a minimum of 4 hours of therapeutic activities, including at least two group therapies ... $110.85 per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>HSCRC programs that meet the minimum requirements of COMAR 10.21.02, at the rate established by the HSCRC;</text> </paragraph> <paragraph num="(3)"> <text>OMHC, for intensive outpatient services provided to a Medicaid recipient in a psychiatric day treatment program:</text> <paragraph num="(a)"> <text>For adults ... $129.69;</text> </paragraph> <paragraph num="(b)"> <text>For children and adolescents ... $154.17; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For physician services, at the rates established under Regulation .06D of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may not reimburse a partial hospitalization program (psychiatric day treatment) or an OMHC intensive outpatient mental health program on the same day that an intensive outpatient program or service is provided for substance abuse treatment.</text> </paragraph> <paragraph num="E."> <text>Residential Crisis Services. The Department shall reimburse a provider for residential crisis services delivered to an individual, as follows:</text> <paragraph num="(1)"> <text>As an alternative to inpatient admission or to shorten the length of inpatient stay:</text> <paragraph num="(a)"> <text>For clinical services ... $252.34 per day;</text> </paragraph> <paragraph num="(b)"> <text>For room and board ... $12.59 per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Treatment foster care ... $162.25 per day; and</text> </paragraph> <paragraph num="(3)"> <text>For physician services, at the rates established for services rendered to an individual in an inpatient setting under Regulation .05D of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Fee Schedule — Support Services."> <paragraph num="A."> <text>Psychiatric Rehabilitation Program (PRP) Services. The Department shall reimburse a PRP for providing face-to-face rehabilitation services to an individual with a serious emotional disturbance (SED) or serious and persistent mental disorder (SPMD), by a monthly rate that is based on a minimum and maximum range of services, when the PRP submits monthly supporting encounter data after services are provided to the individual, within which the provider shall meet the needs of the individual, as follows:</text> <paragraph num="(1)"> <text>Assessment ... $61.62;</text> </paragraph> <paragraph num="(2)"> <text>PRP services to an employed individual in a supported employment program, delivered at the job site, at a rate of $107.62 per month, for:</text> <paragraph num="(a)"> <text>A minimum of two services per month;</text> </paragraph> <paragraph num="(b)"> <text>A maximum of 30 services per month;</text> </paragraph> <paragraph num="(c)"> <text>A minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(d)"> <text>A maximum of one service per day.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional PRP Services. In addition to the services outlined in §A of this regulation, the Department shall reimburse a PRP for providing face-to-face rehabilitation services to an individual with SED or SPMD by a monthly rate that is based on a minimum and maximum range of services, within which the provider shall meet the needs of the individual, as follows:</text> <paragraph num="(1)"> <text>PRP Community Psychiatric Support Services delivered to an individual with an SED or an SPMD, whose functioning is severely impaired, and who is living with a parent, guardian, or relative who is legally responsible for the individual's care, as follows:</text> <paragraph num="(a)"> <text>When on-site and off-site services are delivered to an individual by one PRP, $426.99 per month for:</text> <paragraph num="(i)"> <text>A minimum of three and a maximum of 30 services per month, on-site or off-site;</text> </paragraph> <paragraph num="(ii)"> <text>On-site services, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(iii)"> <text>Off-site services, at a minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(iv)"> <text>A maximum of one on-site or one off-site service per day; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When on-site and off-site services are delivered to an individual by two PRPs, a PRP may receive reimbursement for either on-site or off-site services, but not both, as follows:</text> <paragraph num="(i)"> <text>On-site services, at a rate of $183.22 per month, for a minimum of two services and a maximum of 30 services per month, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(ii)"> <text>Off-site services, at a rate of $243.76 per month, for a minimum of two services and a maximum of 30 services per month, at a minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(iii)"> <text>Limited to reimbursement for one on-site and one off-site service per day;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>PRP supported living for services delivered to an individual with an SED or an SPMD, whose functioning is severely impaired, and who is living independently or with individuals who are not legally responsible for their care, as follows:</text> <paragraph num="(a)"> <text>When services are delivered to an individual by one PRP, $760.88 per month as follows:</text> <paragraph num="(i)"> <text>A minimum of six and a maximum of 30 services per month, on-site or off-site;</text> </paragraph> <paragraph num="(ii)"> <text>On-site services, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(iii)"> <text>Off-site services, at a minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(iv)"> <text>Limited to one on-site and off-site service per day; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When on-site and off-site services are delivered to an individual by two PRPs, a PRP may receive reimbursement for either on-site or off-site services, but not both, as follows:</text> <paragraph num="(i)"> <text>On-site services, at a rate of $259.37 per month, for a minimum of three services and a maximum of 30 services per month, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(ii)"> <text>Off-site services, at a rate of $501.51 per month, for a minimum of five services and a maximum of 30 services per month and a minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(iii)"> <text>Limited to reimbursement for one on-site or off-site service per day;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>PRP services delivered to individuals in residential rehabilitation programs (RRPs) as follows:</text> <paragraph num="(a)"> <text>General support:</text> <paragraph num="(i)"> <text>On-site, at a rate of $447.70 per month, for a minimum of four services, up to 30 services per month, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(ii)"> <text>Off-site, at a rate of $1,202.13 per month, for a minimum of 13 services, up to 30 services per month, at a minimum of 15 minutes per service; or</text> </paragraph> <paragraph num="(iii)"> <text>Any combination of on-site or off-site PRP services, at a rate of $1,649.83 per month, for a minimum of 17 services, up to 30 services per month, at a minimum of 30 minutes per service; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Intensive support:</text> <paragraph num="(i)"> <text>On-site, at a rate of $447.70 per month, for a minimum of four services, up to 30 services per month, at a minimum of 60 minutes per service;</text> </paragraph> <paragraph num="(ii)"> <text>Off-site, at a rate of $3,123.17 per month, for a minimum of 19 services, up to 30 services per month, at a minimum of 15 minutes per service; or</text> </paragraph> <paragraph num="(iii)"> <text>Any combination of on-site or off-site PRP services, at a rate of $3,570.87 per month, for a minimum of 23 services, up to 30 services per month, at a minimum of 30 minutes per service; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>PRP services delivered to individuals when transitioning from inpatient level of care to the community, any combination of on-site or off-site PRP services, at a rate of $447.70 per month, for a minimum of 4 services, up to 30 services per month, at a minimum of 60 minutes per service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>RRP Services. The Department shall reimburse an RRP for providing services to an individual with a serious and persistent mental disorder and whose functioning is severely impaired, as follows:</text> <paragraph num="(1)"> <text>Room and board ... $12.59 per day;</text> </paragraph> <paragraph num="(2)"> <text>A provider may collect additional fees from an individual not covered by the rate established in §B(1) of this regulation to cover a portion of costs of food, shelter, and other household expenses associated with an individual's basic needs in an RRP residence, not to exceed the provider's cost of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Mental Health Vocational Programs (MHVP). The Department shall reimburse a program that is approved for mental health vocational services for providing supported employment services to an individual with a mental disorder:</text> <paragraph num="(1)"> <text>If the service is authorized by the Administration or its designee;</text> </paragraph> <paragraph num="(2)"> <text>If the program documents an individual's application to the Division of Rehabilitation Services (DORS) and has documentation of the decision on the application; and</text> </paragraph> <paragraph num="(3)"> <text>At the following rates, per individual approved for supported employment services:</text> <paragraph num="(a)"> <text>Completion of vocational assessment, individual supported employment plan, referral to DORS, and education regarding entitlements and work incentives, not more than three times per year ... $430.49;</text> </paragraph> <paragraph num="(b)"> <text>Job placement of the individual, not more than three times per year ... $1,075.14;</text> </paragraph> <paragraph num="(c)"> <text>Intensive job coaching, if not otherwise reimbursed, at a maximum of $7.40 per 15 minutes, up to a lifetime maximum of $2,750 per individual; and</text> </paragraph> <paragraph num="(d)"> <text>Extended MHVP support ... $349.77 per month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Mental Health Vocational Programs — Evidence-Based Programs. The Department shall reimburse an MHVP evidence-based program:</text> <paragraph num="(1)"> <text>If the service is authorized by the Administration or its designee;</text> </paragraph> <paragraph num="(2)"> <text>If the program documents an individual's application to the Division of Rehabilitation Services (DORS) and has documentation of the decision on the application; and</text> </paragraph> <paragraph num="(3)"> <text>At the following rates, per individual approved for supported employment services:</text> <paragraph num="(a)"> <text>Completion of vocational assessment, individual supported employment plan, referral to DORS, and education regarding entitlements and work incentives not more than three times per year ... $430.49;</text> </paragraph> <paragraph num="(b)"> <text>Job placement of the individual not more than three times per year ... $1,075.14;</text> </paragraph> <paragraph num="(c)"> <text>Intensive job coaching, if not otherwise reimbursed, at a maximum of $7.40 per 15 minutes, up to a lifetime maximum of $2,750.00 per individual;</text> </paragraph> <paragraph num="(d)"> <text>Clinical service coordination at a rate of $107.62 per month, that is documented and includes, with the individual's consent, at a minimum:</text> <paragraph num="(i)"> <text>Monthly collaboration with the individual's treatment or psychiatric rehabilitation team; and</text> </paragraph> <paragraph num="(ii)"> <text>Face-to-face contact every 6 months with the individual's treating clinician or psychiatrist; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Extended PRP support to an individual in a supported employment program at a rate of $430.49 per month for:</text> <paragraph num="(i)"> <text>A minimum of three services per month;</text> </paragraph> <paragraph num="(ii)"> <text>A maximum of 30 services per month;</text> </paragraph> <paragraph num="(iii)"> <text>A minimum of 15 minutes per service; and</text> </paragraph> <paragraph num="(iv)"> <text>A maximum of one service per day.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Respite Care. The Department shall reimburse a program that is approved for respite care for providing services to a child or adolescent with a serious emotional disturbance, whose functioning is severely impaired, or an adult with a serious and persistent mental disorder, whose functioning is severely impaired, as follows:</text> <paragraph num="(1)"> <text>For children:</text> <paragraph num="(a)"> <text>General support in a facility ... $174.34 per day; or</text> </paragraph> <paragraph num="(b)"> <text>In-home respite, when the need for short-term, one-to-one support is documented or for in-home respite and approved by the CSA up to a maximum of 10 hours per day at a rate of ... $3.49 per 15 minutes;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For adults, general support in a residential rehabilitation program ... $75.61 per day.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Enhanced Support. When the need for short-term, one-to-one support is documented and approved by the CSA, the Department shall reimburse an OMHC, PRP, RRP, or MTS for providing services to a child or adolescent with an SED or an adult with an SPMD, and whose functioning is seriously impaired, at the rate of $12.91 per hour up to a maximum of $129.10 per day, not to exceed 30 days per year.</text> </paragraph> <paragraph num="H."> <text>Therapeutic Behavioral Services. The Department shall reimburse a therapeutic behavioral services provider, as defined in COMAR 10.09.34, as follows:</text> <paragraph num="(1)"> <text>One-to-one behavioral aide services to a child or adolescent ... $5.39 per 15 minutes;</text> </paragraph> <paragraph num="(2)"> <text>Initial assessment and development of a behavioral plan ... $105.51;</text> </paragraph> <paragraph num="(3)"> <text>Reassessment and development of a new behavioral plan ... $99.18.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Adult Mental Health Case Management. The Department shall reimburse a designated program that is approved by the Core Service Agency for mental health case management according to COMAR 10.09.45 for providing case management services to an adult with a serious and persistent mental health disorder as follows:</text> <paragraph num="(1)"> <text>Assessment ... $108.61;</text> </paragraph> <paragraph num="(2)"> <text>Case Management Service units, for a minimum of 60 minutes of face-to-face and non-face-to-face case management service at a rate of $108.61 per day for:</text> <paragraph num="(a)"> <text>General level up to 2 units per month; or</text> </paragraph> <paragraph num="(b)"> <text>Intensive level up to 5 units per month; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When an individual is referred to case management by the Administration or its designee, and is transitioning from an institute for mental disease or hospital, one transitional visit at a rate of $159.55.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Mental Health Case Management: Care Coordination for Children and Youth. The Department shall reimburse a designated program that is approved by the Core Service Agency to provide mental health case management services to a child or adolescent with a serious emotional disorder, according to COMAR 10.09.90, as follows:</text> <paragraph num="(1)"> <text>Case Management Service units, for a minimum of 15 minutes of face-to-face and non-face-to-face case management service at a rate of $20.19 per 15 minutes for:</text> <paragraph num="(a)"> <text>Level I — General Coordination up to 12 units of service per month, with a minimum of two units of face-to-face contact;</text> </paragraph> <paragraph num="(b)"> <text>Level II — Moderate Care Coordination up to 30 units of service per month, with a minimum of four units of face-to-face contact; and</text> </paragraph> <paragraph num="(c)"> <text>Level III — Intensive Care Coordination up to 60 units of service per month, with a minimum of six units of face-to-face contact; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For comprehensive assessment and reassessment case management service units, for Level I and Level II only, four additional face-to-face units of service above the monthly maximum may be billed during the first month of service to the participant and every 6 months thereafter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Fee Schedule — Services — Traumatic Brain Injury (TBI) Waiver Program."> <paragraph num="A."> <text>Residential Habilitation Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide residential habilitation services to an individual who is enrolled in the TBI Waiver Program:</text> <paragraph num="(1)"> <text>At the following rates:</text> <paragraph num="(a)"> <text>Level I ... $192.76 per day;</text> </paragraph> <paragraph num="(b)"> <text>Level II ... $255.24 per day;</text> </paragraph> <paragraph num="(c)"> <text>Level III ... $353.11 per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and</text> </paragraph> <paragraph num="(3)"> <text>According to the institutional level of care determined by the Department's utilization control agent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Day Habilitation Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide day habilitation services to an individual who is enrolled in the TBI Waiver Program:</text> <paragraph num="(1)"> <text>At the following rates:</text> <paragraph num="(a)"> <text>Level I ... $49.76 per day;</text> </paragraph> <paragraph num="(b)"> <text>Level II ... $86.81 per day;</text> </paragraph> <paragraph num="(c)"> <text>Level III ... $122.14 per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and</text> </paragraph> <paragraph num="(3)"> <text>According to the institutional level of care determined by the Department's utilization control agent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Supported Employment Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide supported employment services to an individual who is enrolled in the TBI Waiver Program:</text> <paragraph num="(1)"> <text>At the following rates:</text> <paragraph num="(a)"> <text>Level I ... $29.53 per day;</text> </paragraph> <paragraph num="(b)"> <text>Level II ... $49.76 per day;</text> </paragraph> <paragraph num="(c)"> <text>Level III ... $122.14 per day;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and</text> </paragraph> <paragraph num="(3)"> <text>According to the institutional level of care determined by the Department's utilization control agent.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Individual Support Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide individual support services, as defined in COMAR 10.22.07, to an individual who is enrolled in the TBI Waiver Program at a rate of $24.14 per hour, not to exceed 8 hours per day.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Fee Schedule — Services — Emergency Department."> <text>The Department shall reimburse an emergency department for providing emergency mental health services to an individual who is enrolled in the public mental health system, for services rendered by an appropriately privileged physician or certified registered nurse practitioner — psychiatric as follows:</text> <paragraph num="A."> <text>For a problem focused history, a problem focused examination, and straightforward medical decision making ... $22.27;</text> </paragraph> <paragraph num="B."> <text>For an expanded problem focused history, an expanded problem focused examination, and medical decision making of low complexity ... $43.80;</text> </paragraph> <paragraph num="C."> <text>For an expanded problem focused history, an expanded problem focused examination, and medical decision making of moderate complexity ... $65.29;</text> </paragraph> <paragraph num="D."> <text>For a detailed history, a detailed examination, and medical decision making of moderate complexity ... $124.63;</text> </paragraph> <paragraph num="E."> <text>For a comprehensive history, a comprehensive examination, and medical decision making of high complexity ... $182.80.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Evaluation and Management Services — Including Medication Management."> <paragraph num="A."> <text>New Patients. The Department shall reimburse for evaluation and management services for new patients, including medication management:</text> <paragraph num="(1)"> <text>For a problem focused history, or a problem focused examination, and straightforward medical decision making of minor complexity:</text> <paragraph num="(a)"> <text>OMHC ... $48.70;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $48.70;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $48.70;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an expanded problem focused history, or an expanded problem focused examination, and straightforward medical decision making:</text> <paragraph num="(a)"> <text>OMHC ... $82.48;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $82.48;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $82.48;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a detailed history, or a detailed examination, and medical decision of low complexity:</text> <paragraph num="(a)"> <text>OMHC ... $119.25;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $119.25;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $119.25;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For a comprehensive history, or a comprehensive medical examination, with medical decision making of moderate complexity:</text> <paragraph num="(a)"> <text>OMHC ... $181.64;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $181.64;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $181.64;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For a comprehensive history, or a comprehensive medical examination, with medical decision making of high complexity:</text> <paragraph num="(a)"> <text>OMHC ... $224.53;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $224.53;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $224.53.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Established Patients. The Department shall reimburse for evaluation and management services for established patients, including medication management:</text> <paragraph num="(1)"> <text>For a history, or examination, where presenting problems are minimal, and straightforward medical decision making of minor complexity:</text> <paragraph num="(a)"> <text>OMHC ... $22.72;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $22.72;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $22.72;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a problem focused history, or a problem focused examination, and straightforward medical decision making:</text> <paragraph num="(a)"> <text>OMHC ... $48.70;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $48.70;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $48.70;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For an expanded history, or an expanded examination, and medical decision of low complexity:</text> <paragraph num="(a)"> <text>OMHC ... $80.11;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $80.11;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $80.11;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For a detailed history, or a detailed medical examination, with medical decision making of moderate complexity:</text> <paragraph num="(a)"> <text>OMHC ... $117.60;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $117.60;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $117.60;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For a comprehensive history, or a comprehensive medical examination, with medical decision making of high complexity:</text> <paragraph num="(a)"> <text>OMHC ... $157.64;</text> </paragraph> <paragraph num="(b)"> <text>Physician ... $157.64;</text> </paragraph> <paragraph num="(c)"> <text>Certified registered nurse practitioner — psychiatric ... $157.64.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Crisis Therapy."> <text>The Department shall reimburse an OMHC for crisis therapy, as follows:</text> <paragraph num="A."> <text>For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents:</text> <paragraph num="(1)"> <text>For the first 60 minutes ... $118.37;</text> </paragraph> <paragraph num="(2)"> <text>For an additional period of 30 minutes ... $61.77;</text> </paragraph> </paragraph> <paragraph num="B."> <text>For an adult:</text> <paragraph num="(1)"> <text>For the first 60 minutes ... $100.10;</text> </paragraph> <paragraph num="(2)"> <text>For an additional period of 30 minutes ... $54.16.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901, 15-103, and 15-105; Title 16, Subtitles 1 and 2; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 adopted as an emergency provision effective July 1, 1997 (24:18 Md. R. 1293); adopted permanently effective October 20, 1997 (24:21 Md. R. 1449)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 1, 1998 (25:14 Md. R. 1123)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 1, 1998 (25:18 Md. R. 1435 and 25:19 Md. R. 1506)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective March 1, 2000 (27:4 Md. R. 451); revised permanently effective June 26, 2000 (27:12 Md. R. 1139)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 27, 2003 (30:21 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); adopted permanently effective October 27, 2003 (30:21 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective February 1, 2004 (31:5 Md. R. 446); revised permanently effective June 7, 2004 (31:11 Md. R. 857)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08H adopted effective December 19, 2005 (32:25 Md. R. 1942)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); emergency status extended at 34:4 Md. R. 397; revised permanently effective February 26, 2007 (34:4 Md. R. 400)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02, .03, and .05 — .10 amended as an emergency provision effective July 1, 2008 (35:21 Md. R. 1822)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02, .03, and .05 — .10 amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); amended permanently effective March 23, 2009 (36:6 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 2, 2017 (43:26 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 491)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); emergency status expired June 19, 2009</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05 — .11 amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 — .11 amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 27, 2011 (38:13 Md. R. 755)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective January 2, 2017 (43:26 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09I adopted as an emergency provision effective October 20, 2009 (36:24 Md. R. 1855); adopted permanently effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09I amended effective June 27, 2011 (38:13 Md. R. 755); December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09J adopted effective December 11, 2014 (41:24 Md. R. 1427)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective February 3, 2014 (41:2 Md. R. 91)</annotation> </annotations> </chapter> <chapter num="26" heading="Community Mental Health Programs — Residential Crisis Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the staffing and service requirements for a provider of residential crisis services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Residential crisis services (RCS)” means intensive mental health and support services that are:</text> <paragraph num="(1)"> <text>Provided to a child or an adult with mental illness who is experiencing or is at risk of a psychiatric crisis that would impair the individual's ability to function in the community; and</text> </paragraph> <paragraph num="(2)"> <text>Designed to prevent a psychiatric inpatient admission, provide an alternative to psychiatric inpatient admission, shorten the length of inpatient stay, or reduce the pressure on general hospital emergency departments.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing RCS if the program:</text> <paragraph num="A."> <text>Meets the requirements:</text> <paragraph num="(1)"> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="(2)"> <text>For administration outlined in COMAR 10.21.17; and</text> </paragraph> <paragraph num="(3)"> <text>Of this chapter, including approval, based on the requirements for intensity of services and staffing outlined in this chapter, for one or more of the following:</text> <paragraph num="(a)"> <text>Inpatient admission prevention;</text> </paragraph> <paragraph num="(b)"> <text>Inpatient admission alternative; or</text> </paragraph> <paragraph num="(c)"> <text>Treatment foster care in a foster home licensed under COMAR 07.02.21;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For a program that provides RCS to a child, documents State licensure for the location in which the child will be housed while receiving crisis services; and</text> </paragraph> <paragraph num="C."> <text>For a program that provides services to an adult:</text> <paragraph num="(1)"> <text>Documents State licensure for the location in which the individual will be housed while receiving crisis services;</text> </paragraph> <paragraph num="(2)"> <text>Meets the residential site requirements outlined under COMAR 10.21.22, as documented by the residential specialist; or</text> </paragraph> <paragraph num="(3)"> <text>Is located in subacute beds in an inpatient psychiatric facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>A provider of RCS shall assure that services are:</text> <paragraph num="(1)"> <text>Therapeutic;</text> </paragraph> <paragraph num="(2)"> <text>Provided by staff who, as determined by the program, are appropriately credentialed and privileged;</text> </paragraph> <paragraph num="(3)"> <text>Available:</text> <paragraph num="(a)"> <text>24 hours per day, 7 days per week;</text> </paragraph> <paragraph num="(b)"> <text>On a short-term basis, as needed to resolve an immediate crisis; and</text> </paragraph> <paragraph num="(c)"> <text>At a location in the community, unless given a written exemption from the core service agency (CSA).</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A provider of RCS shall assure that services are adequate to support one or more of the following levels of service:</text> <paragraph num="(1)"> <text>Inpatient admission prevention, which provides:</text> <paragraph num="(a)"> <text>Services to an individual who, based on the individual's history, as evaluated by a physician or a mental health professional, has a mental disorder and, without RCS, is at risk for inpatient admission or cannot be discharged from an inpatient facility; and</text> </paragraph> <paragraph num="(b)"> <text>Staff adequate to support the services under §B(1)(a) of this regulation, as outlined under Regulations .08 and .09 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Inpatient admission alternative, which provides:</text> <paragraph num="(a)"> <text>Services to an individual who, based on an evaluation by a physician or a mental health professional, has a mental disorder, presents a danger to self or others, and would, without RCS, be admitted to or could not be discharged from an inpatient facility; and</text> </paragraph> <paragraph num="(b)"> <text>Staff adequate to support the services under §B(2)(a) of this regulation, as outlined under Regulations .08 and .10 of this chapter, including access to a psychiatrist 24 hours per day, 7 days per week; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Treatment foster care, which provides:</text> <paragraph num="(a)"> <text>Services to an individual who, based on an evaluation by a physician or mental health professional, has a mental disorder, and is in need of a high level of treatment intervention in a family setting; and</text> </paragraph> <paragraph num="(b)"> <text>Staff adequate to support services under §B(3)(a) of this regulation, as outlined under Regulations .08 and .11 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A provider of RCS shall assure that services are designed to:</text> <paragraph num="(1)"> <text>Avert or shorten the length of inpatient admissions;</text> </paragraph> <paragraph num="(2)"> <text>Defuse a current crisis, evaluate the nature of the crisis, stabilize the individual to the pre-crisis level of functioning, and intervene to reduce the likelihood of crisis recurrence;</text> </paragraph> <paragraph num="(3)"> <text>Assist the individual and members of the individual's natural support system to recognize and take preventive action to resolve situations that lead to crisis;</text> </paragraph> <paragraph num="(4)"> <text>Provide counseling, training, and support for crisis prevention, identification, and intervention for individuals and, if appropriate, their families;</text> </paragraph> <paragraph num="(5)"> <text>Link individuals with services and supports in the community including, but not limited to, financial, educational, social, medical, and mental health resources that will enable the individual to:</text> <paragraph num="(a)"> <text>Return to the individual's previous living situation; or</text> </paragraph> <paragraph num="(b)"> <text>Secure an alternative living situation; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Offer a home-like environment that provides goal-directed services to facilitate safe discharge from residential crisis services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A provider of RCS shall assure that services are coordinated with, when appropriate:</text> <paragraph num="(1)"> <text>An individual's custodial agents;</text> </paragraph> <paragraph num="(2)"> <text>Designated psychiatric emergency facilities;</text> </paragraph> <paragraph num="(3)"> <text>Psychiatric inpatient facilities;</text> </paragraph> <paragraph num="(4)"> <text>Psychiatric rehabilitation programs;</text> </paragraph> <paragraph num="(5)"> <text>Outpatient mental health clinics;</text> </paragraph> <paragraph num="(6)"> <text>Somatic care providers;</text> </paragraph> <paragraph num="(7)"> <text>Schools;</text> </paragraph> <paragraph num="(8)"> <text>Other agencies involved with the individual, including, but not limited to:</text> <paragraph num="(a)"> <text>Local departments of social services;</text> </paragraph> <paragraph num="(b)"> <text>Department of Juvenile Services;</text> </paragraph> <paragraph num="(c)"> <text>The local education authority;</text> </paragraph> <paragraph num="(d)"> <text>The local coordinating council (LCC);</text> </paragraph> <paragraph num="(e)"> <text>The local management board; and</text> </paragraph> <paragraph num="(f)"> <text>Criminal justice agencies; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Other public and private providers of mental health services to an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility, Referral, Screening, and Admission."> <paragraph num="A."> <text>Eligibility and Referral.</text> <paragraph num="(1)"> <text>An individual is eligible for RCS if:</text> <paragraph num="(a)"> <text>The individual:</text> <paragraph num="(i)"> <text>Is a participant, as described in COMAR 10.21.25.01D(2), in the public mental health system;</text> </paragraph> <paragraph num="(ii)"> <text>Has a diagnosis that is listed in COMAR 10.09.70.02;</text> </paragraph> <paragraph num="(iii)"> <text>Due to acute symptomatology related to the individual's psychiatric condition, has impaired ability to function within the individual's community living situation and is in need of RCS to avoid inpatient psychiatric admission or to shorten the length of inpatient stay;</text> </paragraph> <paragraph num="(iv)"> <text>For clinical reasons, requires a temporary separation from the individual's current living situation;</text> </paragraph> <paragraph num="(v)"> <text>Has stated a willingness to comply with program rules, or, for a child, a parent or guardian has stated a willingness to comply with program rules;</text> </paragraph> <paragraph num="(vi)"> <text>Expects, with staff support, to be able to comply with treatment recommendations; and</text> </paragraph> <paragraph num="(vii)"> <text>Is able, with staff support, to care for physical needs and basic personal hygiene; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The services are preauthorized, as needed, by the Administration's administrative services organization (ASO) according to the provisions of COMAR 10.21.17.02-1A.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual is not eligible for RCS if the individual:</text> <paragraph num="(a)"> <text>Has a sole diagnosis of substance abuse, mental retardation, or dementia;</text> </paragraph> <paragraph num="(b)"> <text>Is in need of immediate involuntary inpatient psychiatric admission;</text> </paragraph> <paragraph num="(c)"> <text>As determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations, is medically unstable; or</text> </paragraph> <paragraph num="(d)"> <text>Does not meet the eligibility criteria under §A(1)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An RCS program may not exclude an individual solely because the individual:</text> <paragraph num="(a)"> <text>Does not participate in other treatment or rehabilitation programs; or</text> </paragraph> <paragraph num="(b)"> <text>Is homeless.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Screening Assessment.</text> <paragraph num="(1)"> <text>If an individual who is authorized for services has not, before the individual's entry into the RCS program, been evaluated face-to-face by a physician who documents the elements included in this section, an appropriately privileged mental health professional, in collaboration with the individual, shall conduct a screening assessment to:</text> <paragraph num="(a)"> <text>Assess the individual's needs and willingness to participate in RCS;</text> </paragraph> <paragraph num="(b)"> <text>Document:</text> <paragraph num="(i)"> <text>The diagnosis, if any, provided by the referral source; and</text> </paragraph> <paragraph num="(ii)"> <text>If applicable, medications that are prescribed for the individual;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In consultation with the individual and, if any, the referral source, outline a preliminary plan for the RCS services to be provided if the individual enters RCS services, including, at a minimum, the level and type of staff support required for the individual's first 48 hours in the program, and, when appropriate, enhanced support such as:</text> <paragraph num="(i)"> <text>24-hour, on-site;</text> </paragraph> <paragraph num="(ii)"> <text>24-hour, on-site, awake; or</text> </paragraph> <paragraph num="(iii)"> <text>One-to-one; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Inform the individual of the rules of the program and the process and procedure for discharge, including situations as outlined under Regulation .12E of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If, following the assessment under §B(1) of this regulation, the RCS program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall promptly:</text> <paragraph num="(a)"> <text>Inform the individual and, if the individual is a child, the parent or guardian, of the determination and the reason;</text> </paragraph> <paragraph num="(b)"> <text>With proper consent, notify the family or significant others designated by the individual of the determination and of any recommendations for other services; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the CSA and the Administration's ASO for appropriate alternative referral.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Admission. Unless an individual has been re-referred to the Administration's ASO under the provisions of §B(2)(c) of this regulation, an RCS program shall initiate services to an individual if:</text> <paragraph num="(1)"> <text>The individual accepts the rules of the RCS program; and</text> </paragraph> <paragraph num="(2)"> <text>When the individual referred for RCS is a child, the parent or guardian signs an agreement with the provider to accept the child for placement upon discharge from RCS.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluative Services."> <paragraph num="A."> <text>Initial Evaluation. Before the development of the individual treatment plan (ITP), an individual entitled under Health Occupations Article, Annotated Code of Maryland, to render a psychiatric diagnosis shall conduct a face-to-face evaluation with the individual, and, if the individual is a child, with the child's primary caretaker, to:</text> <paragraph num="(1)"> <text>Describe the presenting problem and history of present illness;</text> </paragraph> <paragraph num="(2)"> <text>Collect and evaluate relevant medical and mental health history, including, if any:</text> <paragraph num="(a)"> <text>Previous inpatient and outpatient treatment; and</text> </paragraph> <paragraph num="(b)"> <text>A review of current medications and source of prescriptions;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Evaluate current mental status;</text> </paragraph> <paragraph num="(4)"> <text>Either:</text> <paragraph num="(a)"> <text>Formulate and document a psychiatric diagnosis and the rationale for the diagnosis; or</text> </paragraph> <paragraph num="(b)"> <text>Affirm the psychiatric diagnosis, not more than 1 year old, formulated by the referral source and documented in the individual's medical record; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Identify needed treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Assessment. Before the development of the ITP, the individual's assigned treatment coordinator shall conduct a face-to-face evaluation with the individual, and, if the individual is a child, with the child's primary caretaker, to:</text> <paragraph num="(1)"> <text>Identify the individual's strengths, needs, and desires;</text> </paragraph> <paragraph num="(2)"> <text>Assess the individual's level of functioning and availability of family and other social supports;</text> </paragraph> <paragraph num="(3)"> <text>Complete an assessment that includes, at a minimum, a review of:</text> <paragraph num="(a)"> <text>The individual's:</text> <paragraph num="(i)"> <text>Legal status;</text> </paragraph> <paragraph num="(ii)"> <text>Housing status;</text> </paragraph> <paragraph num="(iii)"> <text>Current employment and economic status;</text> </paragraph> <paragraph num="(iv)"> <text>History of substance abuse;</text> </paragraph> <paragraph num="(v)"> <text>History of physical or sexual abuse;</text> </paragraph> <paragraph num="(vi)"> <text>History of violence or assaultive behaviors;</text> </paragraph> <paragraph num="(vii)"> <text>Natural support system;</text> </paragraph> <paragraph num="(viii)"> <text>Activities of daily living; and</text> </paragraph> <paragraph num="(ix)"> <text>Interpersonal skills; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a child, in addition to the requirements of §B(3)(a) of this regulation, the child's:</text> <paragraph num="(i)"> <text>Developmental status;</text> </paragraph> <paragraph num="(ii)"> <text>Educational history and current placement;</text> </paragraph> <paragraph num="(iii)"> <text>Involvement with other agencies;</text> </paragraph> <paragraph num="(iv)"> <text>Home environment; and</text> </paragraph> <paragraph num="(v)"> <text>Family history and evaluation of the current family status, including legal custody status; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Initiate the process to determine who will provide the individual's mental health care and treatment upon discharge from crisis services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Diagnosis. The program director shall assure that, before the development of the ITP, RCS staff documents the psychiatric diagnosis rendered according to §A(4) of this regulation.</text> </paragraph> <paragraph num="D."> <text>Somatic Care.</text> <paragraph num="(1)"> <text>The program director shall assure that RCS staff coordinates an individual's care with, when known and with proper consent, the individual's somatic care provider.</text> </paragraph> <paragraph num="(2)"> <text>Within 48 hours before or not more than 72 hours after an individual's admission into the program, an individual authorized under Health Occupations Article, Annotated Code of Maryland, shall:</text> <paragraph num="(a)"> <text>Assess the individual's general physical health;</text> </paragraph> <paragraph num="(b)"> <text>Determine whether the individual requires a physical examination or somatic care follow-up; and</text> </paragraph> <paragraph num="(c)"> <text>Make appropriate referrals for services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Treatment Planning and Evaluation."> <paragraph num="A."> <text>Individual Treatment Plan (ITP).</text> <paragraph num="(1)"> <text>Treatment Team. At a minimum the following shall participate as members of an individual's RCS program treatment team:</text> <paragraph num="(a)"> <text>The designated treatment coordinator;</text> </paragraph> <paragraph num="(b)"> <text>Relevant RCS staff providing services to the individual; and</text> </paragraph> <paragraph num="(c)"> <text>When available, relevant staff from other agencies currently providing services to the individual.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individual Treatment Plan. Within 24 hours of placement in an RCS program, based on the screening evaluation under Regulation .05C of this chapter, the initial evaluation under Regulation .06A of this chapter, the assessment under Regulation .06B of this chapter, and the psychiatric diagnosis under Regulation .06C of this chapter, the treatment team shall prepare an ITP:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>The individual;</text> </paragraph> <paragraph num="(ii)"> <text>For a child, the parent or guardian and, if other than the parent or guardian, the primary caretaker; and</text> </paragraph> <paragraph num="(iii)"> <text>When appropriate and with proper consent, the individual's family and others involved in the individual's care;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That includes, at a minimum:</text> <paragraph num="(i)"> <text>The psychiatric diagnosis as provided in Regulation .06C of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the individual's current behavior, symptoms, and level of functioning that includes the individual's presenting strengths, needs, and treatment expectations and responsibilities;</text> </paragraph> <paragraph num="(iii)"> <text>When relevant to the individual, a description of the family's or significant others' needs and strengths;</text> </paragraph> <paragraph num="(iv)"> <text>Mental health treatment goals, including the plan for transition and discharge, to be accomplished during an individual's residence in an RCS program, which are outcome oriented and stated in behavioral, measurable terms; and</text> </paragraph> <paragraph num="(v)"> <text>The anticipated length of stay in the RCS program; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That specifies treatment strategies, including:</text> <paragraph num="(i)"> <text>Recommended modality and frequency of interventions, including, if appropriate, case management services;</text> </paragraph> <paragraph num="(ii)"> <text>Target dates for goal achievement;</text> </paragraph> <paragraph num="(iii)"> <text>The designation of RCS staff responsible for implementing the elements of the plan;</text> </paragraph> <paragraph num="(iv)"> <text>Scheduled daytime activities, if any, such as a partial hospitalization program (PHP), psychiatric rehabilitation program (PRP) on-site or off-site services, and school services; and</text> </paragraph> <paragraph num="(v)"> <text>When appropriate, identification of, recommendations for referral to, and collaboration with, other services to support the individual's treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Signature of the ITP.</text> <paragraph num="(a)"> <text>The individual or, for a child, the parent or guardian shall sign or tape record agreement or disagreement with the ITP and reviews.</text> </paragraph> <paragraph num="(b)"> <text>A child's primary caretaker, if other than the parent or guardian, shall sign or tape record acknowledgment of the ITP and reviews.</text> </paragraph> <paragraph num="(c)"> <text>In addition, the following shall sign the ITP and reviews:</text> <paragraph num="(i)"> <text>The individual's treatment coordinator;</text> </paragraph> <paragraph num="(ii)"> <text>When there is an RCS psychiatrist, the RCS psychiatrist; and</text> </paragraph> <paragraph num="(iii)"> <text>When there is a mental health professional, the mental health professional.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Discharge Before the ITP. When an individual is discharged within 24 hours of admission to RCS, if the treatment team has not developed an ITP, the treatment coordinator shall document, in the individual's medical record, a brief description of the goals established and interventions employed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Continued Evaluation.</text> <paragraph num="(1)"> <text>Contact Notes. In order to assure that services to an individual are timely and appropriate, staff shall document in the individual's medical record contact notes regarding all clinically relevant face-to-face, telephone, and written contacts with or about the individual, including the dates, locations, and types of contacts.</text> </paragraph> <paragraph num="(2)"> <text>Progress Summary Notes. The individual's treatment coordinator shall document or assure that staff document in the individual's medical record a daily progress summary note that includes:</text> <paragraph num="(a)"> <text>A description of progress toward goals;</text> </paragraph> <paragraph num="(b)"> <text>Changes in goals and interventions based on the review of progress; and</text> </paragraph> <paragraph num="(c)"> <text>The rationale for the changes.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Required Staff."> <paragraph num="A."> <text>The program director shall ensure that the RCS staff is sufficient in numbers and qualifications to carry out the program's service goals and includes, at a minimum, the staff identified in this regulation and Regulations .09 — .11 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Program Director. The governing body shall employ a program director who:</text> <paragraph num="(1)"> <text>As determined by the governing body, has sufficient qualifications, knowledge, and experience to execute the duties of the position;</text> </paragraph> <paragraph num="(2)"> <text>Is available to provide RCS administration and supervision:</text> <paragraph num="(a)"> <text>For the amount of time necessary to carry out the duties and, at a minimum, 10 hours per week; and</text> </paragraph> <paragraph num="(b)"> <text>If a RCS program operates in more than one site, by:</text> <paragraph num="(i)"> <text>Designating, as necessary, staff to manage services at each site and report to the program director and</text> </paragraph> <paragraph num="(ii)"> <text>Having contact with each site each week;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is responsible for operational oversight for, at a minimum:</text> <paragraph num="(a)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17 and the day-to-day operations of the RCS program;</text> </paragraph> <paragraph num="(b)"> <text>Maintaining sufficient staff, including recruiting, hiring, scheduling, and terminating;</text> </paragraph> <paragraph num="(c)"> <text>Consulting on the development and implementation of the budget;</text> </paragraph> <paragraph num="(d)"> <text>Keeping the governing body informed of, at a minimum, the program's approval status and performance; and</text> </paragraph> <paragraph num="(e)"> <text>In collaboration with appropriate RCS staff, assuring staff compliance with:</text> <paragraph num="(i)"> <text>Credentialing and privileging;</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate training and supervision; and</text> </paragraph> <paragraph num="(iii)"> <text>When required, the on-call availability of a psychiatrist; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If appropriately credentialed and privileged, may provide RCS services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment Coordinator. The program director shall assign to each individual who is receiving RCS a treatment coordinator who, as privileged by the program, shall provide or coordinate the services outlined in this chapter for the specific type and level of RCS.</text> </paragraph> <paragraph num="D."> <text>Direct Service Providers. The program director shall employ a sufficient number of direct service providers who:</text> <paragraph num="(1)"> <text>As determined by the program, have sufficient qualifications and experience to carry out the duties of the position;</text> </paragraph> <paragraph num="(2)"> <text>Before providing services, have training applicable to the service, including, at a minimum, training in:</text> <paragraph num="(a)"> <text>Crisis intervention;</text> </paragraph> <paragraph num="(b)"> <text>Suicide prevention;</text> </paragraph> <paragraph num="(c)"> <text>Behavior modification; and</text> </paragraph> <paragraph num="(d)"> <text>Family interactions; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, provide the level and intensity of supervision and support required under this chapter for the specific type and level of RCS indicated in an individual's ITP.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Staff Support and Mental Health Services — Inpatient Admission Prevention."> <paragraph num="A."> <text>Staff Support. The program director shall assure that the program:</text> <paragraph num="(1)"> <text>Has at least one staff person on duty at all times that a resident is present in the RCS facility;</text> </paragraph> <paragraph num="(2)"> <text>Has the capacity for and, when required by an individual's ITP, provides 24-hour awake staff support;</text> </paragraph> <paragraph num="(3)"> <text>Has the capacity for 1:4 coverage and, when required by an individual's ITP, provides 1:4 coverage; and</text> </paragraph> <paragraph num="(4)"> <text>If the program serves children, provides at least one staff member for every three children.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Psychiatric Evaluation and Intervention. The program director shall assure that a psychiatrist provides evaluation and prescribed needed treatment interventions, either:</text> <paragraph num="(1)"> <text>By consultation with the psychiatrist who is currently treating the individual; or</text> </paragraph> <paragraph num="(2)"> <text>Through a written agreement with a provider of mental health treatment, who will provide face-to-face evaluation by a psychiatrist before the development of the ITP.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment and Support Services.</text> <paragraph num="(1)"> <text>The program director shall assign to each individual who is receiving RCS a treatment coordinator who shall assure that the individual receives:</text> <paragraph num="(a)"> <text>The care or treatment recommended under Regulation .07A of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Monitoring of the individual's condition;</text> </paragraph> <paragraph num="(c)"> <text>Supportive counseling focused on:</text> <paragraph num="(i)"> <text>Assessment and definition of problems;</text> </paragraph> <paragraph num="(ii)"> <text>Planning and goal setting;</text> </paragraph> <paragraph num="(iii)"> <text>Development of effective problem-solving techniques; and</text> </paragraph> <paragraph num="(iv)"> <text>Evaluation of progress;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Assistance in accessing community resources, including case management, that are essential to meeting the individual's identified needs; and</text> </paragraph> <paragraph num="(e)"> <text>Transition services and discharge planning.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medication Services.</text> <paragraph num="(a)"> <text>Monitoring. A member of the treatment team privileged to do so shall provide the following medication monitoring services:</text> <paragraph num="(i)"> <text>Supporting the individual's self-administration of medications, including both prescribed and over-the-counter medications;</text> </paragraph> <paragraph num="(ii)"> <text>To the extent possible, monitoring compliance with instructions appearing on the label or a more recent physician's order;</text> </paragraph> <paragraph num="(iii)"> <text>Reading the label to assure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date;</text> </paragraph> <paragraph num="(iv)"> <text>Assuring that each individual has secure, appropriate, and accessible space in which to store medications;</text> </paragraph> <paragraph num="(v)"> <text>Observing and documenting medications taken and any apparent reactions to the medication, and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority problems that possibly may be related to the medication; and</text> </paragraph> <paragraph num="(vi)"> <text>Reinforcing education on the role and effects of medication in symptom management.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Administration. If an individual's ITP requires that RCS staff administer medication, only an individual authorized to do so under Health Occupations Article, Annotated Code of Maryland, may administer medication.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Staff Support and Mental Health Services — Inpatient Admission Alternative."> <paragraph num="A."> <text>Staff Support. The program director shall ensure:</text> <paragraph num="(1)"> <text>That sufficient staff are on duty at all times to relate to the expected clinical needs of the individuals in the residence; and</text> </paragraph> <paragraph num="(2)"> <text>At a minimum:</text> <paragraph num="(a)"> <text>The provision of at least one on-site, awake staff for every four individuals receiving RCS or, if a child is in the residence, one staff for every three individuals;</text> </paragraph> <paragraph num="(b)"> <text>The availability, based upon clinical acuity and the request of on-duty staff, of at least one other staff member to arrive at the RCS program within 1 hour of a request; and</text> </paragraph> <paragraph num="(c)"> <text>That the program has the capacity for 1:1 coverage, and provides 1:1 coverage when clinically indicated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Psychiatric Evaluation and Intervention. The program director shall assure that a psychiatrist:</text> <paragraph num="(1)"> <text>Is available on call, 24 hours per day, 7 days per week;</text> </paragraph> <paragraph num="(2)"> <text>Within 24 hours of an individual's admission:</text> <paragraph num="(a)"> <text>Conducts a face-to-face evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Either:</text> <paragraph num="(i)"> <text>Formulates and documents a psychiatric diagnosis and the rationale for the diagnosis; or</text> </paragraph> <paragraph num="(ii)"> <text>Affirms the psychiatric diagnosis formulated under Regulation .06A(4) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Through participation in the ITP, prescribes treatment interventions; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the individual presents a danger to self, indicates appropriate staff coverage and precautions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment and Support Services.</text> <paragraph num="(1)"> <text>The program director shall ensure that a mental health professional:</text> <paragraph num="(a)"> <text>Provides regular supervision of all treatment staff; and</text> </paragraph> <paragraph num="(b)"> <text>Each day, either:</text> <paragraph num="(i)"> <text>Monitors, face-to-face, an individual's condition and documents significant changes; or</text> </paragraph> <paragraph num="(ii)"> <text>Consults with staff regarding the clinical needs of an individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The program director shall assign a treatment coordinator who shall assure that the individual receives:</text> <paragraph num="(a)"> <text>Care or treatment recommended under Regulation .07A of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The services under Regulation .09C(1)(c) — (e) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medication Services.</text> <paragraph num="(a)"> <text>Monitoring. When required by the individual's ITP, a member of the treatment team credentialed and privileged to do so shall provide medication monitoring, as outlined in Regulation .09C(2)(a) of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>Administration. The program director shall assure that an individual authorized under Health Occupations Article, Annotated Code of Maryland, is available to administer medication in a case where medication administration is required by an individual's ITP.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Staff Support and Mental Health Services — Treatment Foster Care."> <paragraph num="A."> <text>Staff Support. The RCS program director shall assure that:</text> <paragraph num="(1)"> <text>RCS mental health professional staff provides, to the foster care provider, specialized training in mental health crisis recognition, management, and intervention, before placing any individuals in the foster home; and</text> </paragraph> <paragraph num="(2)"> <text>The RCS program has the capacity to provide staff to deliver, in the foster home, on an emergency basis:</text> <paragraph num="(a)"> <text>24-hour, awake supervision; and</text> </paragraph> <paragraph num="(b)"> <text>One-to-one support.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Psychiatric Evaluation and Intervention. The program director shall ensure appropriate evaluation and documentation of needed treatment interventions:</text> <paragraph num="(1)"> <text>By consultation with the psychiatrist who is currently treating the individual;</text> </paragraph> <paragraph num="(2)"> <text>Through a written agreement with a provider of mental health treatment, who will provide face-to-face evaluation by a psychiatrist before the development of the ITP; or</text> </paragraph> <paragraph num="(3)"> <text>Through a written agreement with an outpatient mental health clinic, approved under COMAR 10.21.20, that will provide consultation with a psychiatrist and face-to-face evaluation by a mental health professional privileged by the program and appointed by the medical director to provide the service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment and Support Services.</text> <paragraph num="(1)"> <text>The program director shall assure that:</text> <paragraph num="(a)"> <text>An individual receives the care or treatment outlined in the ITP under Regulation .07A of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>As required by an individual's ITP, a mental health professional is available to provide mental health services on site at the foster home.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medication Services.</text> <paragraph num="(a)"> <text>A foster care provider shall:</text> <paragraph num="(i)"> <text>Administer an individual's medications, as permitted under COMAR 10.27.11; or</text> </paragraph> <paragraph num="(ii)"> <text>Monitor an individual's self-administration of medications.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The program director shall assure that, if an individual's ITP requires that RCS staff provide medication services, monitoring or administration of medication is carried out as outlined under Regulation .09C(2) of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Transition and Discharge."> <paragraph num="A."> <text>Discharge Policy. The program director shall:</text> <paragraph num="(1)"> <text>Collaborate with the Administration's ASO to:</text> <paragraph num="(a)"> <text>Arrange for discharge from the program when services are no longer authorized by the Administration's ASO; and</text> </paragraph> <paragraph num="(b)"> <text>Make recommendations for referral for alternative services for an individual for whom the program's services are not appropriate; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain clearly written policies and procedures for:</text> <paragraph num="(a)"> <text>Transition services;</text> </paragraph> <paragraph num="(b)"> <text>Collaborative discharge from the program; and</text> </paragraph> <paragraph num="(c)"> <text>Making recommendations for discharge and referral for alternative services for an individual for whom the program's services are not appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Transition. The treatment coordinator shall:</text> <paragraph num="(1)"> <text>Collaborate with the Administration's ASO to provide interim services and assure appropriate referrals for authorization for case management and other service providers before discharge; and</text> </paragraph> <paragraph num="(2)"> <text>With proper consent and while the individual is still in the RCS program, contact the providers who have been authorized to provide the services designated in the discharge summary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Collaborative Discharge. When the Administration's ASO, in consultation with the treatment coordinator, determines that services are no longer medically necessary, the rehabilitation coordinator shall:</text> <paragraph num="(1)"> <text>Prepare a discharge plan based on an assessment of the individual's current service needs and mutually agreed upon goals, in collaboration with:</text> <paragraph num="(a)"> <text>The individual, and, for a child, the primary caretaker; and</text> </paragraph> <paragraph num="(b)"> <text>With proper consent:</text> <paragraph num="(i)"> <text>Family or significant others designated by the individual; and</text> </paragraph> <paragraph num="(ii)"> <text>When feasible, other treatment and service providers;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>When needed, make appropriate recommendations to the Administration's ASO for treatment, rehabilitation, and community supports; and</text> </paragraph> <paragraph num="(3)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> <paragraph num="D."> <text>Individual's Discontinuation of Services. When an individual discontinues services before a planned, collaborative discharge as described in §C of this regulation, the treatment coordinator shall:</text> <paragraph num="(1)"> <text>When possible, give the individual information about appropriate alternate services;</text> </paragraph> <paragraph num="(2)"> <text>If authorized by the Administration's ASO, provide appropriate outreach to encourage the individual to access appropriate services;</text> </paragraph> <paragraph num="(3)"> <text>With proper consent, provide notice of the discontinuation to:</text> <paragraph num="(a)"> <text>The emergency contact named by the individual at the time of admission;</text> </paragraph> <paragraph num="(b)"> <text>When feasible, other service providers, including the individual's somatic care provider, when known; and</text> </paragraph> <paragraph num="(c)"> <text>When needed, the CSA and the Administration's ASO, for referral for appropriate alternative services; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> <paragraph num="E."> <text>Program's Recommendation to Discontinue Services. If, in consultation with the program director, the treatment coordinator recommends discharging an individual who does not comply with the program's rules or for whom the program's services are not appropriate, the program director shall:</text> <paragraph num="(1)"> <text>Provide written notice of the intention to discharge from services and recommend referral for alternative services:</text> <paragraph num="(a)"> <text>To the individual and, for a child, the parent or guardian and, if other than the parent or guardian, the primary caretaker;</text> </paragraph> <paragraph num="(b)"> <text>With proper consent to:</text> <paragraph num="(i)"> <text>The emergency contact named by the individual at the time of admission;</text> </paragraph> <paragraph num="(ii)"> <text>When feasible, other service providers; and</text> </paragraph> <paragraph num="(iii)"> <text>When needed, the CSA and the Administration's ASO, for referral for appropriate alternative services;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That includes:</text> <paragraph num="(i)"> <text>The effective date of the action;</text> </paragraph> <paragraph num="(ii)"> <text>The reason for the action; and</text> </paragraph> <paragraph num="(iii)"> <text>When possible, a discharge plan; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 28, 1998 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective June 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 13, 2007 (34:16 Md. R. 1432)</annotation> </annotations> </chapter> <chapter num="27" heading="Community Mental Health Programs — Respite Care Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the staffing and service requirements for a provider of respite care services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17 and in this regulation.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Respite care” means services that are:</text> <paragraph num="(1)"> <text>Provided for an adult with serious and persistent mental illness or a child with serious emotional disturbance;</text> </paragraph> <paragraph num="(2)"> <text>Provided on a short-term basis in a community-based setting; and</text> </paragraph> <paragraph num="(3)"> <text>Designed to support an individual to remain in the individual's home by:</text> <paragraph num="(a)"> <text>Providing the individual with enhanced support or a temporary alternative living situation; or</text> </paragraph> <paragraph num="(b)"> <text>Assisting the individual's home caregiver by temporarily freeing the caregiver from the responsibility of caring for the individual.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing respite care services if the program:</text> <paragraph num="A."> <text>Is approved as:</text> <paragraph num="(1)"> <text>A mobile treatment services (MTS) provider under COMAR 10.21.19;</text> </paragraph> <paragraph num="(2)"> <text>An outpatient mental health clinic (OMHC) under COMAR 10.21.20; or</text> </paragraph> <paragraph num="(3)"> <text>A psychiatric rehabilitation program (PRP) under COMAR 10.21.21; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Meets the requirements of this chapter, including approval to provide either or both of the following specific respite care services:</text> <paragraph num="(1)"> <text>In-home respite, in an individual's place of residence;</text> </paragraph> <paragraph num="(2)"> <text>Out-of-home respite, in a home or facility that is appropriately licensed, registered, or approved, based on:</text> <paragraph num="(a)"> <text>The age of individuals receiving services; and</text> </paragraph> <paragraph num="(b)"> <text>Whether the respite is partial day or overnight.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>The program director shall assure that respite care services are:</text> <paragraph num="(1)"> <text>Designed to fit the needs of the individuals served and their caregivers; and</text> </paragraph> <paragraph num="(2)"> <text>Delivered by individuals who are privileged by the program to provide a particular service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>As approved under this chapter, a program may provide respite care services as needed for an individual:</text> <paragraph num="(1)"> <text>With advance planning; or</text> </paragraph> <paragraph num="(2)"> <text>As needed in an immediate situation, to resolve or ameliorate a problem in the living situation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Referral, Eligibility, Screening, and Acceptance for Respite Services."> <paragraph num="A."> <text>Referral. An individual or the individual's caregiver may request respite care services, or an agency providing mental health treatment or support services to an individual may refer the individual for respite care services.</text> </paragraph> <paragraph num="B."> <text>Eligibility.</text> <paragraph num="(1)"> <text>An individual is eligible to receive respite care if:</text> <paragraph num="(a)"> <text>The individual is a participant, as described in COMAR 10.21.25.01D(2), in the public mental health system;</text> </paragraph> <paragraph num="(b)"> <text>The individual has a diagnosis that is listed in COMAR 10.09.70.02;</text> </paragraph> <paragraph num="(c)"> <text>The individual is:</text> <paragraph num="(i)"> <text>An adult who has serious and persistent mental illness and who lives independently or in a family-like setting, or in a residential rehabilitation program (RRP) under the provisions of COMAR 10.21.22; or</text> </paragraph> <paragraph num="(ii)"> <text>A child who has a serious emotional disturbance and who lives with a parent, guardian, or other primary caretaker in a family-like home, or in a foster home under the provisions of COMAR 07.02.11 or 07.02.21; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The services are preauthorized, as needed, by the Administration's administrative services organization (ASO) according to the provisions of COMAR 10.21.17.02-1A.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual is not eligible to receive respite care if the individual is a resident of a therapeutic group home (TGH) licensed under COMAR 10.21.07 or a facility licensed under Health-General Article, Title 19, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Screening. Upon receipt of a referral for respite care, the program director shall ensure that respite care staff:</text> <paragraph num="(1)"> <text>Conduct a screening assessment with the:</text> <paragraph num="(a)"> <text>Individual for whom respite care services are requested;</text> </paragraph> <paragraph num="(b)"> <text>The caregiver or significant other, if any; and</text> </paragraph> <paragraph num="(c)"> <text>Referral source, if any;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evaluate whether the respite care is needed:</text> <paragraph num="(a)"> <text>At a specific future time;</text> </paragraph> <paragraph num="(b)"> <text>Immediately; or</text> </paragraph> <paragraph num="(c)"> <text>Intermittently;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Outline, in consultation with the individual and the caregiver, a preliminary plan, including the schedule for respite care, for the services to be provided in accordance with this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Based on consultation with the individual and, if any, the referral source, document:</text> <paragraph num="(a)"> <text>The expected duration of the respite care;</text> </paragraph> <paragraph num="(b)"> <text>The frequency, level, and type of staff contacts needed, such as staff availability:</text> <paragraph num="(i)"> <text>At a minimum, on call, 24 hours per day, 7 days per week; or</text> </paragraph> <paragraph num="(ii)"> <text>On site for up to 24 hours per day, 7 days per week; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If applicable, medications that are prescribed for the individual; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Inform the individual and the caregiver of the rules for the respite care episode.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Acceptance. Upon acceptance of an individual for respite care, staff assigned by the program director, in consultation with the individual and the caregiver, shall:</text> <paragraph num="(1)"> <text>Perform an assessment of:</text> <paragraph num="(a)"> <text>The individual's and the caregiver's strengths and needs; and</text> </paragraph> <paragraph num="(b)"> <text>Interventions needed by the individual during respite;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order to ensure continuity of care, document information regarding, at a minimum, the individual's participation in:</text> <paragraph num="(a)"> <text>Outpatient mental health treatment;</text> </paragraph> <paragraph num="(b)"> <text>Psychiatric rehabilitation;</text> </paragraph> <paragraph num="(c)"> <text>School;</text> </paragraph> <paragraph num="(d)"> <text>Work; or</text> </paragraph> <paragraph num="(e)"> <text>Other scheduled activities;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Taking into consideration the needs under §§C(4) and D(2) of this regulation, formulate an initial plan for respite services, including the:</text> <paragraph num="(a)"> <text>Schedule for providing respite care;</text> </paragraph> <paragraph num="(b)"> <text>Location;</text> </paragraph> <paragraph num="(c)"> <text>Level of staff support;</text> </paragraph> <paragraph num="(d)"> <text>Schedule of the individual's activities during respite; and</text> </paragraph> <paragraph num="(e)"> <text>Needed interventions to facilitate the individual's remaining in or returning to the living situation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Respite Services Provided."> <text>The program director shall ensure that:</text> <paragraph num="A."> <text>Services are planned according to the duration, frequency, and location of the respite care;</text> </paragraph> <paragraph num="B."> <text>An individual receives services according to a plan that includes:</text> <paragraph num="(1)"> <text>Based on the initial plan under Regulation .05D(3) of this chapter, a schedule of the individual's activities during respite;</text> </paragraph> <paragraph num="(2)"> <text>When needed, medication monitoring; and</text> </paragraph> <paragraph num="(3)"> <text>The frequency and intensity of staff support;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Services are coordinated with an individual's individual treatment plan or individual rehabilitation plan;</text> </paragraph> <paragraph num="D."> <text>Respite staff document a plan to be implemented in the event of a crisis; and</text> </paragraph> <paragraph num="E."> <text>Staff provide referrals or coordinate referrals with other current treatment providers, as needed, for additional services for the individual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Conclusion of Respite Episode."> <paragraph num="A."> <text>Planned Conclusion. At the agreed upon time of conclusion of a respite care episode, the program director shall assure that staff document a summary of the episode in the individual's record.</text> </paragraph> <paragraph num="B."> <text>Individual's Discontinuation of Services. If an individual elects to discontinue services before the planned conclusion of a respite episode, as described in §A of this regulation, the program director shall:</text> <paragraph num="(1)"> <text>Promptly notify the individual's caregiver or designated emergency contact;</text> </paragraph> <paragraph num="(2)"> <text>If the individual is a child, discharge the child only to an adult who is legally responsible for the child;</text> </paragraph> <paragraph num="(3)"> <text>Notify the CSA and the Administration's ASO of the action; and</text> </paragraph> <paragraph num="(4)"> <text>Assure that staff document a summary of the episode in the individual's record.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Program's Recommendation to Discontinue Services. If the program director recommends discharging an individual who does not comply with the program's rules or for whom the program's services are not appropriate, the program director shall follow the provisions outlined in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Respite Staff."> <paragraph num="A."> <text>Respite Care Program Director. The MTS, OMHC, or PRP program director shall either:</text> <paragraph num="(1)"> <text>Carry out the respite care program director's duties that are delineated in this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Appoint a respite care program director with sufficient qualifications, knowledge, and experience to execute the duties of the position.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Respite Care Specialists. The respite care program director shall employ a sufficient number of staff who:</text> <paragraph num="(1)"> <text>As determined by the program director, have sufficient qualifications and experience to carry out the duties of the position;</text> </paragraph> <paragraph num="(2)"> <text>Before providing services, have training applicable to the service, including, at a minimum, training in:</text> <paragraph num="(a)"> <text>Mental illness and emotional disorders;</text> </paragraph> <paragraph num="(b)"> <text>Psychiatric medications;</text> </paragraph> <paragraph num="(c)"> <text>Crisis intervention;</text> </paragraph> <paragraph num="(d)"> <text>Family interactions; and</text> </paragraph> <paragraph num="(e)"> <text>For staff who provide services to children:</text> <paragraph num="(i)"> <text>Growth and development; and</text> </paragraph> <paragraph num="(ii)"> <text>Behavioral intervention; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, are available to carry out the:</text> <paragraph num="(a)"> <text>Program model described in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Activities outlined in an individual's respite care plan under Regulation .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 16, 1998 (25:23 Md. R. 1697)</annotation> </annotations> </chapter> <chapter num="28" heading="Community Mental Health Programs — Mental Health Vocational Programs (MHVP)"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the staffing and service requirements that a mental health vocational program (MHVP) shall fulfill to be approved by the Department to be eligible to receive State or federal funds to provide services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17 and in this regulation.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Agency-Sponsored Employment.</text> <paragraph num="(a)"> <text>“Agency-sponsored employment” means an employment program designed to assist an individual to obtain employment at locations owned, leased, rented, or managed by the provider, at other locations by an agency-held contract, at a consumer-operated business or program, or work enclave that provides:</text> <paragraph num="(i)"> <text>Compensation to individuals according to the standards established by the Department of Labor;</text> </paragraph> <paragraph num="(ii)"> <text>Opportunity for individuals to have contact with nondisabled individuals and the public to the same extent that nondisabled individuals in comparable positions interact with the public; and</text> </paragraph> <paragraph num="(iii)"> <text>Additional supports, as needed, to the individual in the work setting.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Agency-sponsored employment” does not include sheltered workshops.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Competitive work” means employment in the competitive labor market that pays minimum wage or higher and compensation is consistent with the wage standards provided in the Fair Labor Standards Act.</text> </paragraph> <paragraph num="(3)"> <text>“Consumer-operated business” means a program owned or managed by an individual who has a disclosed mental illness that provides compensated employment for an individual who has a disclosed mental illness.</text> </paragraph> <paragraph num="(4)"> <text>“Employment specialist” means a program staff member who helps individuals in the public mental health system (PMHS) to:</text> <paragraph num="(a)"> <text>Obtain competitive employment;</text> </paragraph> <paragraph num="(b)"> <text>Learn work tasks;</text> </paragraph> <paragraph num="(c)"> <text>Resolve job-related or on-the-job problems; and</text> </paragraph> <paragraph num="(d)"> <text>Maintain competitive employment.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Extended support services” means ongoing support services and other appropriate services needed to support and maintain an individual after the individual has made the transition from time-limited, intensive job-coaching services.</text> </paragraph> <paragraph num="(6)"> <text>“Industry” means the employer hiring an individual in the public mental health system.</text> </paragraph> <paragraph num="(7)"> <text>“Integrated work” means work that provides an individual an opportunity to interact with nondisabled individuals.</text> </paragraph> <paragraph num="(8)"> <text>“Intensive job coaching” means frequent and intensive support provided to an individual at a job site and off a job site during the initial stages of an individual's employment in order for an individual to learn and to manage a job.</text> </paragraph> <paragraph num="(9)"> <text>“Job stability” means a situation in which an individual is performing job duties satisfactorily and is reasonably expected to continue that level of performance.</text> </paragraph> <paragraph num="(10)"> <text>“Natural support” means the assistance received from an individual's family members, significant others, friends, neighbors, and coworkers.</text> </paragraph> <paragraph num="(11)"> <text>“Sheltered workshop” means employment in a workshop or work-activity center or a physically separated department of an agency or organization having an identifiable program of rehabilitation, separate tasks, supervision, records, and compensation for individuals with disabilities.</text> </paragraph> <paragraph num="(12)"> <text>“Supported employment program” means a program designed to assist an individual to obtain competitive employment in an integrated work environment that provides:</text> <paragraph num="(a)"> <text>Compensation to individuals of at least minimum wage;</text> </paragraph> <paragraph num="(b)"> <text>An individualized approach that establishes an hours-per-week employment goal to maximize an individual's vocational potential;</text> </paragraph> <paragraph num="(c)"> <text>Additional supports, as needed, delivered where appropriate; and</text> </paragraph> <paragraph num="(d)"> <text>Transitional employment placements, as appropriate.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Transitional employment” means a series of planned temporary, sequential job placements, with continuous support services, provided to an individual in the public mental health system until job permanency is achieved.</text> </paragraph> <paragraph num="(14)"> <text>“Work enclave” means a group of individuals with mental illness for whom an agency:</text> <paragraph num="(a)"> <text>Has negotiated access to jobs in community businesses;</text> </paragraph> <paragraph num="(b)"> <text>Guarantees completion of the individuals' work; and</text> </paragraph> <paragraph num="(c)"> <text>Provides compensation for the hours worked.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department may approve a program as an MHVP if the program meets the requirements:</text> <paragraph num="A."> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="B."> <text>For administration outlined in COMAR 10.21.17; and</text> </paragraph> <paragraph num="C."> <text>Of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Authorization for Services."> <text>Before rendering services to an individual, a provider shall notify the core service agency (CSA) of the jurisdiction in which the individual resides and receive preauthorization for services.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Program Model."> <text>The program director shall ensure that services:</text> <paragraph num="A."> <text>Are designed to:</text> <paragraph num="(1)"> <text>Support an individual in the public mental health system to be able to:</text> <paragraph num="(a)"> <text>Choose, obtain, and maintain employment;</text> </paragraph> <paragraph num="(b)"> <text>Make vocational decisions and career changes; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Enhance an individual's natural supports;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Are provided in a flexible manner to support an individual's vocational plan throughout an individual's employment, including periods of unemployment;</text> </paragraph> <paragraph num="C."> <text>Include:</text> <paragraph num="(1)"> <text>Ongoing assessment and planning with an individual and, when appropriate, an individual's family or natural supports;</text> </paragraph> <paragraph num="(2)"> <text>As needed, vocational training;</text> </paragraph> <paragraph num="(3)"> <text>Marketing to industries in the community; and</text> </paragraph> <paragraph num="(4)"> <text>Referral for services an individual needs, which are not provided by the program;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Promote placement in a work environment that:</text> <paragraph num="(1)"> <text>Is free of recognized hazards likely to cause serious bodily injury or death and comply with any specific safety and health standards set for the industry;</text> </paragraph> <paragraph num="(2)"> <text>If not free of all recognized hazards likely to cause serious bodily injury or death, provides information to employees regarding the exposure to hazardous materials and substances; and</text> </paragraph> <paragraph num="(3)"> <text>Compensates individuals at least at minimum wage; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>Are adequate to support an individual's placement in a supported employment program or an agency-sponsored employment program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Eligibility, Screening, and Enrollment."> <paragraph num="A."> <text>Eligibility. An individual is eligible for MHVP services if:</text> <paragraph num="(1)"> <text>The individual:</text> <paragraph num="(a)"> <text>Is a participant in the public mental health system;</text> </paragraph> <paragraph num="(b)"> <text>Has a diagnosis listed in COMAR 10.09.70.02;</text> </paragraph> <paragraph num="(c)"> <text>Is an individual for whom competitive employment has not occurred, has been interrupted, or has been intermittent;</text> </paragraph> <paragraph num="(d)"> <text>Wants to work; and</text> </paragraph> <paragraph num="(e)"> <text>Is in need of ongoing MHVP services to enable the individual to choose, obtain, or maintain employment; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The services are preauthorized by the CSA of the jurisdiction in which the individual resides.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening.</text> <paragraph num="(1)"> <text>Upon receipt of a referral and when appropriate, the program shall request authorization from the appropriate CSA to provide services.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 working days of receipt by the program of CSA authorization for MHVP assessment under §A(2) of this regulation, staff assigned by the program director, in collaboration with the individual, shall conduct a screening assessment to:</text> <paragraph num="(a)"> <text>Assess the individual's:</text> <paragraph num="(i)"> <text>Interest in employment and desire to work;</text> </paragraph> <paragraph num="(ii)"> <text>Willingness to participate in MHVP services; and</text> </paragraph> <paragraph num="(iii)"> <text>MHVP services needs; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Determine the program's ability to address the individual's employment needs identified in §B(2)(a)(iii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>After the screening under §B(2) of this regulation, if the program director determines that a program's services are not appropriate for an individual, the program director shall, in writing, promptly:</text> <paragraph num="(a)"> <text>Inform the individual of the determination and the reason;</text> </paragraph> <paragraph num="(b)"> <text>Provide the individual with recommendations for alternative services;</text> </paragraph> <paragraph num="(c)"> <text>With proper consent, notify the family or significant others designated by the individual, of the determination and of any recommendations for other services; and</text> </paragraph> <paragraph num="(d)"> <text>Notify the CSA of the determination.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Within 10 working days of the screening conducted under §B(2) of this regulation, unless the program director has notified the individual and the CSA of the determination under §B(3) of this regulation, the program director shall notify the individual that the program either:</text> <paragraph num="(a)"> <text>Accepts the individual and identifies a date that the program proposes to initiate services to the individual; or</text> </paragraph> <paragraph num="(b)"> <text>Will accept the individual, following an updated review of the individual's eligibility status, when program capacity permits.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the individual is accepted under §B(4)(b) of this regulation, the program director shall inform the individual of the:</text> <paragraph num="(a)"> <text>Individual's placement on a waiting list, if any; and</text> </paragraph> <paragraph num="(b)"> <text>Estimated date services may be initiated.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the individual is placed on a waiting list under §B(5)(a) of this regulation, the program director shall discuss with the individual:</text> <paragraph num="(a)"> <text>The option of remaining on the program's waiting list until the date established under §B(5)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Alternative services that are available.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Enrollment. Within 10 working days of the date established under §B(4)(a) of this regulation or following an updated review under §B(4)(b) of this regulation, MHVP staff assigned by the program director shall:</text> <paragraph num="(1)"> <text>Provide an orientation to the program, including:</text> <paragraph num="(a)"> <text>A description of the MHVP services available; and</text> </paragraph> <paragraph num="(b)"> <text>The individual's rights and responsibilities; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In writing, inform the individual of the policy and procedures for discharge, including conditions, as outlined in Regulation .11D of this chapter, that may result in the program's discharging an individual, and making recommendations for alternative services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Assessment and Planning Services."> <paragraph num="A."> <text>Vocational Assessment. Within 10 working days of initiation of MHVP services, MHVP staff assigned by the program director to conduct assessments, in collaboration with the individual and, with proper consent, family or significant others designated by the individual, shall complete a face-to-face MHVP assessment that includes, at a minimum:</text> <paragraph num="(1)"> <text>Documentation of the individual's employment interests, preferences, and skills;</text> </paragraph> <paragraph num="(2)"> <text>An evaluation that identifies the individual's competencies, work needs, and readiness for employment;</text> </paragraph> <paragraph num="(3)"> <text>Identification of obstacles and barriers to work such as transportation and impact on entitlements;</text> </paragraph> <paragraph num="(4)"> <text>Relevant information from the screening conducted under Regulation .06B of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>If appropriate, relevant information from previous vocational screenings or assessments.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individual Vocational Plan (IVP).</text> <paragraph num="(1)"> <text>Initial IVP. Within 30 days of initiation of MHVP services and based on the vocational assessment completed according to §A of this regulation, the individual's employment specialist shall prepare an initial IVP:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>The individual;</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, family or significant others designated by the individual and others involved in the individual's care; and</text> </paragraph> <paragraph num="(iii)"> <text>If appropriate and with proper consent, other mental health service providers, as available;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That, if applicable and with proper consent, is coordinated with the:</text> <paragraph num="(i)"> <text>Maryland State Department of Education, Division of Rehabilitation Services' (DORS) individual plan for employment; and</text> </paragraph> <paragraph num="(ii)"> <text>Individual's individual treatment plan, individual rehabilitation plan, and case management personal plan;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That is designed to assist the individual to identify, obtain, and maintain vocational goals;</text> </paragraph> <paragraph num="(d)"> <text>That identifies the individual's:</text> <paragraph num="(i)"> <text>Strengths;</text> </paragraph> <paragraph num="(ii)"> <text>Vocational service needs;</text> </paragraph> <paragraph num="(iii)"> <text>Vocational goals, including target dates;</text> </paragraph> <paragraph num="(iv)"> <text>Vocational interventions, including but not limited to a systematic plan of instruction in work skills and behaviors to be learned and, if applicable, benefits management and staff responsible for implementation; and</text> </paragraph> <paragraph num="(v)"> <text>Plan for obtaining a job that matches the individual's interests, preferences, abilities, and needed accommodations and adaptations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>IVP Review. As frequently as necessary, as determined by an individual's employment specialist, and at least every 6 months, the employment specialist, in consultation with the individual, shall:</text> <paragraph num="(a)"> <text>Review and record in the individual's employment record:</text> <paragraph num="(i)"> <text>The individual's progress toward the accomplishment of previously identified vocational goals;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes, based on a review of the individual's progress; and</text> </paragraph> <paragraph num="(iii)"> <text>Changes in interventions, including staff responsibility;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Communicate promptly the results of the review to:</text> <paragraph num="(i)"> <text>Relevant program staff; and</text> </paragraph> <paragraph num="(ii)"> <text>With the individual's consent, community mental health programs providing services to the individual and family or significant others;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Assess the individual's satisfaction with the job and the MHVP services; and</text> </paragraph> <paragraph num="(d)"> <text>When the individual is employed through agency-sponsored employment, assess the individual's preferences and readiness for competitive work.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Signature of the IVP and IVP Reviews. The employment specialist shall obtain the individual's written or witnessed verbal agreement or disagreement with the plan, and, in addition, the following shall sign the plan and reviews:</text> <paragraph num="(a)"> <text>The employment specialist; and</text> </paragraph> <paragraph num="(b)"> <text>Other MHVP staff responsible for implementing the plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Evaluation. At least once a month the employment specialist shall record in the individual's MHVP employment record a progress summary note regarding:</text> <paragraph num="(1)"> <text>The delivery of services, including those outlined in Regulation .07B(1)(d) of this chapter, specified by the IVP;</text> </paragraph> <paragraph num="(2)"> <text>Progress toward goal achievement;</text> </paragraph> <paragraph num="(3)"> <text>Changes in the individual's status;</text> </paragraph> <paragraph num="(4)"> <text>If applicable, coordination with DORS; and</text> </paragraph> <paragraph num="(5)"> <text>If applicable, suggested changes in employment goals and vocational services delivered.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="MHVP Services."> <paragraph num="A."> <text>Entitlement and Resource Education Services. The program director shall ensure that MHVP staff educate an individual about:</text> <paragraph num="(1)"> <text>The financial impact of employment on disability benefits, entitlements, and other benefits;</text> </paragraph> <paragraph num="(2)"> <text>Access to such Social Security programs as Plan to Achieve Self- Sufficiency and Impairment-Related Work Expense and the individual's rights and responsibilities under such programs;</text> </paragraph> <paragraph num="(3)"> <text>Access to additional benefits and other resources; and</text> </paragraph> <paragraph num="(4)"> <text>Benefits and risks of disclosure to the employer of the individual's disability.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Job Development and Placement Services. The program director shall ensure that MHVP staff:</text> <paragraph num="(1)"> <text>Develop close cooperation with industries, unions, and other community resources related to employment opportunities;</text> </paragraph> <paragraph num="(2)"> <text>Regularly survey the local business community and develop an ongoing marketing strategy to increase employment opportunities for individuals served;</text> </paragraph> <paragraph num="(3)"> <text>When appropriate, facilitate an appropriate match between an individual and a job by reviewing the:</text> <paragraph num="(a)"> <text>Benefits and wages;</text> </paragraph> <paragraph num="(b)"> <text>Necessary work skills;</text> </paragraph> <paragraph num="(c)"> <text>Required functional abilities;</text> </paragraph> <paragraph num="(d)"> <text>If applicable, accommodations and adaptations required for the individual;</text> </paragraph> <paragraph num="(e)"> <text>Opportunities to participate in work-related social activities to develop natural support; and</text> </paragraph> <paragraph num="(f)"> <text>Employee orientation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When appropriate, ensure that the individual receives, at a minimum, information regarding the:</text> <paragraph num="(a)"> <text>Job duties;</text> </paragraph> <paragraph num="(b)"> <text>Salary scale and benefits;</text> </paragraph> <paragraph num="(c)"> <text>Work schedule;</text> </paragraph> <paragraph num="(d)"> <text>Responsibilities of the employer;</text> </paragraph> <paragraph num="(e)"> <text>Responsibilities of the individual;</text> </paragraph> <paragraph num="(f)"> <text>Fringe benefits;</text> </paragraph> <paragraph num="(g)"> <text>Wage payment practices;</text> </paragraph> <paragraph num="(h)"> <text>Nondiscrimination provisions; and</text> </paragraph> <paragraph num="(i)"> <text>Process for the filing and resolution of grievances; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>When an individual's employment status changes, assists the individual to maintain the goal of employment by facilitating additional job placements.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Employment Support Services. The program director shall ensure that, as required by an individual's IVP, the individual's employment specialist:</text> <paragraph num="(1)"> <text>Provides or arranges for the provision of:</text> <paragraph num="(a)"> <text>Job coaching, which includes training in job tasks and responsibilities;</text> </paragraph> <paragraph num="(b)"> <text>Assistance, upon request, and with the individual's consent, to the industry on effective strategies to help the individual remain on the job; and</text> </paragraph> <paragraph num="(c)"> <text>Activities directed toward the development of skills, including, but not limited to:</text> <paragraph num="(i)"> <text>Personal hygiene and grooming specific to the employment environment;</text> </paragraph> <paragraph num="(ii)"> <text>Effective communication with supervisor and coworkers; and</text> </paragraph> <paragraph num="(iii)"> <text>Transportation to and from work; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Extended support services, which may include §C(1)(a) — (c) of this regulation, in order to assist the individual to maintain employment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Encourages the individual to:</text> <paragraph num="(a)"> <text>Use natural supports; and</text> </paragraph> <paragraph num="(b)"> <text>Develop an employment-related support system through relationships with coworkers, supervisors, and others in the work environment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provides the services outlined in this regulation, when appropriate, and with the individual's consent, at the job site or at another location appropriate to the individual's needs; and</text> </paragraph> <paragraph num="(4)"> <text>Has at least two face-to-face contacts a month with the individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Additional Requirements — Supported Employment Model."> <text>In addition to the requirements under Regulations .01B(1) and .05E(1) of this chapter, an MHVP supporting individuals in a SEP program shall provide:</text> <paragraph num="A."> <text>With proper consent, at least one contact per month with the industry to receive information regarding the individual's performance on the job; and</text> </paragraph> <paragraph num="B."> <text>The services outlined in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Additional Requirements — Agency-Sponsored Employment Model."> <text>In addition to the requirements under Regulations .01B(2) and .05E(2) of this chapter, an MHVP supporting individuals in an agency-sponsored program shall:</text> <paragraph num="A."> <text>Provide additional supports to the individual at the work site, which shall include:</text> <paragraph num="(1)"> <text>Staff, on site, during the hours the individual is employed, to provide:</text> <paragraph num="(a)"> <text>Supervision;</text> </paragraph> <paragraph num="(b)"> <text>Skills assessment;</text> </paragraph> <paragraph num="(c)"> <text>On-the-job training; and</text> </paragraph> <paragraph num="(d)"> <text>Mentoring; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation of an assessment of the individual's potential for community employment at least semiannually;</text> </paragraph> </paragraph> <paragraph num="B."> <text>In accordance with personnel policy and procedure, provide the individual with the following, if provided to nondisabled employees:</text> <paragraph num="(1)"> <text>Employee benefits;</text> </paragraph> <paragraph num="(2)"> <text>For each pay period, a written statement that indicates gross pay, hours worked, deductions, and net pay;</text> </paragraph> <paragraph num="(3)"> <text>Consistent with federal wage and hour laws at least annually, a review of the individual's wages and work performance; and</text> </paragraph> <paragraph num="(4)"> <text>Wages based on individual performance rather than on group wage payments;</text> </paragraph> </paragraph> <paragraph num="C."> <text>If paying subminimum wages, be in compliance with DOL regulations, documented by the appropriate DOL certificate; and</text> </paragraph> <paragraph num="D."> <text>Provide the services outlined in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Discharge from Services."> <paragraph num="A."> <text>Discharge Policy. The program director shall:</text> <paragraph num="(1)"> <text>Maintain clearly written policies and procedures for:</text> <paragraph num="(a)"> <text>The process for discharge;</text> </paragraph> <paragraph num="(b)"> <text>If the program's services are not appropriate for the individual, making recommendations for discontinuing services and referring the individual for alternative services, including the criteria for discontinuing services according to this paragraph; and</text> </paragraph> <paragraph num="(c)"> <text>Providing the individual with information about how to reaccess services when needed; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notify the authorizing CSA of the determination under §A(1)(b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Collaborative Discharge. When the employment specialist, in collaboration with the individual, determines that MHVP services are no longer appropriate, the employment specialist shall:</text> <paragraph num="(1)"> <text>Prepare a discharge plan:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>The individual; and</text> </paragraph> <paragraph num="(ii)"> <text>With proper consent, family or significant others designated by the individual and, if feasible, other treatment and service providers; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That is based on an assessment of the individual's current vocational status, service needs, and mutually agreed-upon goals;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>As necessary, make appropriate recommendations for treatment, rehabilitation, and community supports;</text> </paragraph> <paragraph num="(3)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3); and</text> </paragraph> <paragraph num="(4)"> <text>Notify the CSA of the discharge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Individual's Discontinuation of Services. When an individual discontinues services before a planned, collaborative discharge as described in §B of this regulation, the employment specialist shall:</text> <paragraph num="(1)"> <text>If possible, give the individual information about appropriate alternative services;</text> </paragraph> <paragraph num="(2)"> <text>If authorized, provide outreach to encourage the individual to access appropriate services;</text> </paragraph> <paragraph num="(3)"> <text>With proper consent and if needed, provide notice of the discontinuation to the CSA or the Department's administrative services organization for referral for appropriate alternative services; and</text> </paragraph> <paragraph num="(4)"> <text>Complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program's Recommendation to Discontinue Services.</text> <paragraph num="(1)"> <text>If, in consultation with the program director, the employment specialist recommends discontinuing services for an individual for whom, because of the individual's actions, the program's services are not appropriate, the program director shall provide written notice of the intention to discontinue services and recommend referral for alternative services.</text> </paragraph> <paragraph num="(2)"> <text>Except in the case of imminent danger, the program director shall provide the notice at least 30 days before discontinuing services.</text> </paragraph> <paragraph num="(3)"> <text>The program director shall ensure that the notice is sent to the individual and, with proper consent, to the CSA or the Department's administrative services organization for referral for appropriate alternative services.</text> </paragraph> <paragraph num="(4)"> <text>The program director shall include in the notice:</text> <paragraph num="(a)"> <text>The effective date of the action;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the action; and</text> </paragraph> <paragraph num="(c)"> <text>If possible, a discharge plan.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The program director shall ensure that staff complete a discharge summary in accordance with COMAR 10.21.17.07D(3).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Program Staff."> <paragraph num="A."> <text>A provider of MHVP shall ensure that MHVP staff includes, at a minimum:</text> <paragraph num="(1)"> <text>A program director who:</text> <paragraph num="(a)"> <text>Has sufficient qualifications, knowledge, and experience to execute the duties of the position;</text> </paragraph> <paragraph num="(b)"> <text>Is available for an amount of time calculated on the basis of a half-hour per individual receiving services, up to a maximum of 40 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>Is available to provide MHVP administration and supervision; and</text> </paragraph> <paragraph num="(d)"> <text>May provide MHVP services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Employment specialists who have sufficient qualifications, knowledge, and experience to work with the individuals served by the program; and</text> </paragraph> <paragraph num="(3)"> <text>Program staff sufficient to carry out the:</text> <paragraph num="(a)"> <text>Program model described in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Services delineated under Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Activities outlined in the individual's IVP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The program director shall assure that the MHVP:</text> <paragraph num="(1)"> <text>Has a clear description of the role and function of the staff providing MHVP services;</text> </paragraph> <paragraph num="(2)"> <text>Staff is sufficient in numbers and qualifications to carry out the program's service goals and includes, at a minimum, the staff identified in this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Has a contingency plan for staff availability to provide necessary MHVP services to an individual in the absence of regularly assigned staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Ratio. A provider of MHVP services shall maintain a maximum ratio of one MHVP employment specialist serving each 15 individuals receiving MHVP services.</text> </paragraph> <paragraph num="D."> <text>Volunteers, Students, and Trainees. The program may use volunteers, students, and trainees according to the provisions of COMAR 10.21.17.09E.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 9, 2001 (28:13 Md. R. 1215)</annotation> </annotations> </chapter> <chapter num="29" heading="Community Mental Health Programs — Psychiatric Rehabilitation Services for Minors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter outlines the service requirements and staffing standards for a psychiatric rehabilitation program (PRP) for minors that provides psychiatric rehabilitative services to a minor.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department shall grant approval to a program to be eligible to receive State or federal funds for providing PRP services for minors if the program meets the requirements:</text> <paragraph num="A."> <text>For approval outlined in COMAR 10.21.16;</text> </paragraph> <paragraph num="B."> <text>For administration outlined in COMAR 10.21.17;</text> </paragraph> <paragraph num="C."> <text>For Medical Assistance providers outlined in COMAR 10.09.36, 10.09.59, and 10.09.70; and</text> </paragraph> <paragraph num="D."> <text>Of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Model."> <paragraph num="A."> <text>A provider of PRP services for minors shall:</text> <paragraph num="(1)"> <text>Have a facility that:</text> <paragraph num="(a)"> <text>Meets all relevant federal, State, or local ordinances, laws, regulations, and orders governing the program;</text> </paragraph> <paragraph num="(b)"> <text>Is not located in a private residence;</text> </paragraph> <paragraph num="(c)"> <text>Is accessible to the public; and</text> </paragraph> <paragraph num="(d)"> <text>Contains a secure area where records, logs, and business information may be kept;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prominently display the hours of operation of the facility;</text> </paragraph> <paragraph num="(3)"> <text>Provide services at the PRP facility and at other locations according to the needs of the individuals served;</text> </paragraph> <paragraph num="(4)"> <text>Assure that individuals receiving services have the choice to receive services on-site or at another suitable location; and</text> </paragraph> <paragraph num="(5)"> <text>Assure that program staff are available by telephone, on call, 24 hours per day, 7 days per week.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program director shall organize program services and supports to:</text> <paragraph num="(1)"> <text>Facilitate the development of a minor's independent living and social skills, including the minor's ability to make decisions about the minor's life and create opportunities for choice, to the degree that is age and developmentally appropriate, regarding:</text> <paragraph num="(a)"> <text>Home;</text> </paragraph> <paragraph num="(b)"> <text>School or work; and</text> </paragraph> <paragraph num="(c)"> <text>Community; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Promote the use of community resources to integrate the minor into the community.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program director shall ensure that:</text> <paragraph num="(1)"> <text>Services are:</text> <paragraph num="(a)"> <text>Appropriate to the age of the populations being served;</text> </paragraph> <paragraph num="(b)"> <text>Offered at times suitable to the minors served;</text> </paragraph> <paragraph num="(c)"> <text>Coordinated with other mental health services that the minor is receiving;</text> </paragraph> <paragraph num="(d)"> <text>Goal directed;</text> </paragraph> <paragraph num="(e)"> <text>Outcome focused;</text> </paragraph> <paragraph num="(f)"> <text>Available as long as the minor meets medical necessity criteria for PRP services;</text> </paragraph> <paragraph num="(g)"> <text>Based on a functional assessment of the minor across life domains;</text> </paragraph> <paragraph num="(h)"> <text>Part of a total plan of care, which is directed at maintaining the minor in their home and preventing out-of-home placement;</text> </paragraph> <paragraph num="(i)"> <text>Integrated with the minor's ITP; and</text> </paragraph> <paragraph num="(j)"> <text>Designed to reduce functional behavioral impairments and restore and strengthen age-appropriate skills;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the PRP provides services to minors in a specific age group or with a particular clinical profile, the initiation of service criteria is consistent with the populations to be served;</text> </paragraph> <paragraph num="(3)"> <text>When the PRP provides services in a facility, the services shall be provided on a regular basis and include a variety of group and individual rehabilitation activities that incorporate individual rehabilitation goals; and</text> </paragraph> <paragraph num="(4)"> <text>If the PRP provides services to both minors and adults, the program activities for minors are separate from program activities for adults, unless the adult receiving PRP services is a parent or caregiver of the minor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Notification and Consent Requirements."> <paragraph num="A."> <text>A parent or guardian of a minor shall receive all notifications and information regarding PRP services for a minor, unless the minor is 16 years old or older and has consented to PRP services rather than a parent.</text> </paragraph> <paragraph num="B."> <text>If a minor who is 16 years old or older and has consented to PRP services rather than a parent or guardian, consent from the minor shall be obtained before providing a parent or guardian any notifications or information regarding PRP services for a minor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility, Screening, and Initiation of Service."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>A minor is eligible for PRP services if, as a result of a serious emotional disturbance, the:</text> <paragraph num="(a)"> <text>Minor:</text> <paragraph num="(i)"> <text>Has been referred for PRP services by a licensed mental health professional who is providing inpatient, residential treatment center, or outpatient mental health services to the minor;</text> </paragraph> <paragraph num="(ii)"> <text>Is currently in, and remains in active mental health treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Has the appropriate consent to participate in PRP services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Administration's administrative services organization:</text> <paragraph num="(i)"> <text>Determines that the services are medically necessary; and</text> </paragraph> <paragraph num="(ii)"> <text>Authorizes the services according to the provisions of COMAR 10.21.17.03A.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>PRP services for minors shall be prioritized for minors who have a serious emotional disturbance and who meet the following eligibility criteria:</text> <paragraph num="(a)"> <text>Have severe functional impairments in at least one or more life domains;</text> </paragraph> <paragraph num="(b)"> <text>Based on the clinical evaluation and ongoing treatment plan, are, with PRP services, expected to have reduced symptoms of their mental illness or their functional behavioral impairment as a result of their mental illness;</text> </paragraph> <paragraph num="(c)"> <text>Have an impairment as a result of their mental illness that results in:</text> <paragraph num="(i)"> <text>A clear, current threat to the minor's ability to be maintained in the minor's customary setting;</text> </paragraph> <paragraph num="(ii)"> <text>An emerging or pending risk to the safety of the minor or others; or</text> </paragraph> <paragraph num="(iii)"> <text>Other evidences of significant psychological or social impairment such as inappropriate social behavior causing serious problems with peer or family relationships;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Due to dysfunction, is at risk for requiring a higher level of care, or is returning from a higher level of care;</text> </paragraph> <paragraph num="(e)"> <text>There is clinical evidence that:</text> <paragraph num="(i)"> <text>The current intensity of outpatient treatment will not be sufficient to reduce the minor's symptoms and functional behavioral impairment resulting from the mental illness and restore the minor to an appropriate functional level, or prevent clinical deterioration, or avert the need to initiate a more intensive level of care due to the current risk to the individual or others; or</text> </paragraph> <paragraph num="(ii)"> <text>For minors transitioning from an inpatient, day hospital, or residential treatment setting to a community setting, PRP services will be necessary to prevent clinical deterioration and support successful transition back to the community, or avert the need to initiate or continue a more intensive level of care;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The minor's disorder can be expected to improve through medically necessary rehabilitation or there is clinical evidence that this intensity of psychiatric rehabilitation is needed to maintain the minor's level of functioning; and</text> </paragraph> <paragraph num="(g)"> <text>The minor is judged to be in enough behavioral control to be safe in the psychiatric rehabilitation program and benefit from the psychiatric rehabilitation provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to those minors outlined in §A(1) and (2) of this regulation, a PRP for minors may provide services to other minors who either contract privately for services or for whom another agency contracts for services.</text> </paragraph> <paragraph num="(4)"> <text>If a PRP for minors provides services to a minor outlined in §A(3) of this regulation, the PRP may not seek reimbursement by the PMHS for providing services to that minor.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Screening.</text> <paragraph num="(1)"> <text>Within 5 working days of receipt by the program of a complete referral for PRP services, staff assigned by the program director, in collaboration with the minor and the minor's parent or guardian, if appropriate, shall schedule an appointment to conduct a face-to-face screening assessment to:</text> <paragraph num="(a)"> <text>Assess the minor's:</text> <paragraph num="(i)"> <text>Rehabilitation services needs;</text> </paragraph> <paragraph num="(ii)"> <text>Willingness to participate in PRP services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Determine the program's ability to address the needs identified in §B(1)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for a minor who has been referred, the program director shall, in writing, promptly:</text> <paragraph num="(a)"> <text>Inform the minor and the parent or guardian, if appropriate, of the determination and the reason; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the minor, and the parent or guardian, if appropriate, with recommendations for alternative services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 5 working days of the screening assessment conducted under §B(1) of this regulation, unless the program director has notified the minor of the determination under §B(2) of this regulation, the program director shall notify the minor and the parent or guardian, if appropriate, whether the program:</text> <paragraph num="(a)"> <text>Accepts the minor and identifies a date that the program can initiate services to the minor;</text> </paragraph> <paragraph num="(b)"> <text>Will accept the minor, following an updated review of the minor's eligibility status, when program capacity permits, and inform the minor of the:</text> <paragraph num="(i)"> <text>Minor's placement on a waiting list, if any; and</text> </paragraph> <paragraph num="(ii)"> <text>Estimated date services may be initiated; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Will accept the minor following the minor's discharge or release from an inpatient facility, RTC, or detention center.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the minor is placed on a waiting list under §B(3)(b) of this regulation, the program director shall discuss with the minor and, if appropriate, the minor's parent or guardian:</text> <paragraph num="(a)"> <text>The option of remaining on the program's waiting list until the date established under §B(3)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Alternative services that are available.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Initiation of Services. Before the initiation of services, PRP staff assigned by the program director shall:</text> <paragraph num="(1)"> <text>Document:</text> <paragraph num="(a)"> <text>That a parent or guardian has applied for entitlements for which the minor may be eligible;</text> </paragraph> <paragraph num="(b)"> <text>If the application has been made, the outcome of the minor's application; and</text> </paragraph> <paragraph num="(c)"> <text>If the application has not been made, that staff have assisted the minor's parent or guardian to apply for entitlements; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Discuss with the minor and, if appropriate, the minor's parent or guardian, and provide written documentation to the minor and, if appropriate, the minor's parent or guardian, of the charges for services and, if applicable, the process for determining ability to pay.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluation and Planning Services."> <paragraph num="A."> <text>Review of Somatic Status.</text> <paragraph num="(1)"> <text>According to provisions outlined in this section and upon a minor's enrollment into the program, a staff member assigned by the program director shall document in the minor's medical record:</text> <paragraph num="(a)"> <text>Pertinent past and current medical history including:</text> <paragraph num="(i)"> <text>The minor's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant medical treatment, including medications; and</text> </paragraph> <paragraph num="(iii)"> <text>Needed somatic care follow-up, if any; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the minor does not have a primary care provider, and, if indicated, the plan, including the time frame, for the minor's referral to a primary care provider for evaluation and treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If indicated, the minor's rehabilitation coordinator shall document and communicate with the minor's primary care provider.</text> </paragraph> <paragraph num="(3)"> <text>If indicated, the minor's rehabilitation coordinator shall discuss with the minor, and the parent or guardian, if appropriate, the need for medical care and facilitate access to said care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Rehabilitation Assessment.</text> <paragraph num="(1)"> <text>Within 14 calendar days of initiation of PRP services, PRP staff assigned by the program director to conduct assessments, in collaboration with the minor and, with proper consent, the parent or guardian, shall complete a face-to-face rehabilitation assessment.</text> </paragraph> <paragraph num="(2)"> <text>The assigned staff shall document in the rehabilitation assessment, at a minimum:</text> <paragraph num="(a)"> <text>The minor's age and developmentally appropriate strengths, skills, and needs in the following areas:</text> <paragraph num="(i)"> <text>Self-care skills;</text> </paragraph> <paragraph num="(ii)"> <text>Social, peer, family, and teacher interaction skills;</text> </paragraph> <paragraph num="(iii)"> <text>Participation in psychiatric treatment;</text> </paragraph> <paragraph num="(iv)"> <text>Semi-independent living skills;</text> </paragraph> <paragraph num="(v)"> <text>Family support and resources;</text> </paragraph> <paragraph num="(vi)"> <text>Academic achievement;</text> </paragraph> <paragraph num="(vii)"> <text>Community and informal support systems; and</text> </paragraph> <paragraph num="(viii)"> <text>Adaptive equipment or resources;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>As relevant, a review of the minor's legal status and forensic history, if any; and</text> </paragraph> <paragraph num="(c)"> <text>The minor's history of physical abuse, sexual abuse, or substance abuse, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Individual Rehabilitation Plan.</text> <paragraph num="(1)"> <text>Initial IRP. Within 30 calendar days of initiation of PRP services and based on the rehabilitation assessment described in §B of this regulation, the minor's rehabilitation coordinator shall prepare an initial IRP:</text> <paragraph num="(a)"> <text>In collaboration with:</text> <paragraph num="(i)"> <text>The minor;</text> </paragraph> <paragraph num="(ii)"> <text>The parent or guardian, if appropriate; and</text> </paragraph> <paragraph num="(iii)"> <text>If appropriate and with proper consent, other mental health service providers, as available;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That includes, at a minimum:</text> <paragraph num="(i)"> <text>The minor's presenting needs, strengths, and rehabilitation expectations and responsibilities;</text> </paragraph> <paragraph num="(ii)"> <text>A description of needed and desired program services and interventions and staff responsible for implementation;</text> </paragraph> <paragraph num="(iii)"> <text>A description of how the needed and desired skills and supports will help the minor to be successfully maintained in the home or community, and manage the minor's psychiatric disorder;</text> </paragraph> <paragraph num="(iv)"> <text>Rehabilitation goals in measurable terms, and target dates for each goal; and</text> </paragraph> <paragraph num="(v)"> <text>If appropriate, identification of, recommendations for, and collaboration with, other services to support the minor's rehabilitation, including but not limited to mental health treatment, residential services, and somatic care; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>That is reflective of the minor's overall plan of care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individual Treatment and Rehabilitation Plan (ITRP). In collaboration with the mental health treatment coordinator, the rehabilitation coordinator may combine the required elements of an ITP and IRP in one document, the ITRP.</text> </paragraph> <paragraph num="(3)"> <text>Rehabilitation Plan Review. As frequently as necessary, as determined by a minor's rehabilitation coordinator, and, at a minimum of every 3 months, the rehabilitation coordinator, in consultation with the minor, shall:</text> <paragraph num="(a)"> <text>Review and record in the minor's medical record:</text> <paragraph num="(i)"> <text>The minor's progress toward the accomplishment of previously identified rehabilitation goals;</text> </paragraph> <paragraph num="(ii)"> <text>Goal changes, based on a review of the minor's progress;</text> </paragraph> <paragraph num="(iii)"> <text>Changes in interventions, as appropriate; and</text> </paragraph> <paragraph num="(iv)"> <text>Progress toward the reduction of functional behavioral impairments and restoration of specific age-appropriate skills;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Communicate promptly the results of the review to:</text> <paragraph num="(i)"> <text>Relevant program staff;</text> </paragraph> <paragraph num="(ii)"> <text>The minor's parent or guardian, if appropriate;</text> </paragraph> <paragraph num="(iii)"> <text>With proper consent, community mental health programs providing services to the minor; and</text> </paragraph> <paragraph num="(iv)"> <text>With proper consent, the referring licensed mental health provider; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the minor's service needs change, provide and document in the minor's record:</text> <paragraph num="(i)"> <text>The suggested changes in rehabilitation goals and services; and</text> </paragraph> <paragraph num="(ii)"> <text>Staffing and support services required by the change.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Signature of the IRP Plan and Reviews.</text> <paragraph num="(a)"> <text>The following shall sign agreement with the IRP and ITRP reviews:</text> <paragraph num="(i)"> <text>The minor;</text> </paragraph> <paragraph num="(ii)"> <text>The minor's rehabilitation coordinator; and</text> </paragraph> <paragraph num="(iii)"> <text>The minor's parent or guardian, if appropriate.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the minor is unwilling to sign an agreement with the IRP and ITRP reviews, the minor's rehabilitation coordinator shall:</text> <paragraph num="(i)"> <text>Verify the minor's verbal agreement with the IRP and ITRP reviews;</text> </paragraph> <paragraph num="(ii)"> <text>Document the rationale for the minor's refusal to sign; and</text> </paragraph> <paragraph num="(iii)"> <text>Obtain the agreement and signature of agreement of the minor's parent or guardian.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In addition, for an ITRP, at least two mental health professionals, who collaborate about the minor's treatment, shall sign the IRP and ITRP reviews, including:</text> <paragraph num="(i)"> <text>The minor's rehabilitation coordinator, and if the rehabilitation coordinator is not a mental health professional, the mental health professional who supervises the rehabilitation coordinator; and</text> </paragraph> <paragraph num="(ii)"> <text>The minor's treating mental health professional;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the minor is receiving medication prescribed through an outpatient mental health clinic (OMHC), the minor's rehabilitation coordinator shall provide the OMHC psychiatrist with a copy of the minor's IRP and ITRP reviews.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing Evaluation.</text> <paragraph num="(1)"> <text>Contact Notes. Staff shall document:</text> <paragraph num="(a)"> <text>Each contact with or about the individual, including, at a minimum:</text> <paragraph num="(i)"> <text>The date;</text> </paragraph> <paragraph num="(ii)"> <text>The start and end time of services, if not documented in a readily accessible billing document;</text> </paragraph> <paragraph num="(iii)"> <text>The minor's chief medical complaint or reason for the visit;</text> </paragraph> <paragraph num="(iv)"> <text>The delivery of services specified by the IRP or ITRP;</text> </paragraph> <paragraph num="(v)"> <text>A brief description of the service provided; and</text> </paragraph> <paragraph num="(vi)"> <text>A legible signature, which may include an electronic signature, and printed or typed name of the program staff member providing care, with the appropriate title.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Progress Summary Notes. At a minimum, each month, the rehabilitation coordinator shall record in the minor's medical record a progress summary note that includes:</text> <paragraph num="(a)"> <text>The staff member's assessment of the minor's progress toward goal achievement in measurable terms;</text> </paragraph> <paragraph num="(b)"> <text>The minor's assessment of progress toward goal achievement; and</text> </paragraph> <paragraph num="(c)"> <text>Justification for the need for ongoing PRP services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If at least one contact note described in §D(1) of this regulation includes the information outlined in §D(2) of this regulation, the monthly progress summary note is not required.</text> </paragraph> <paragraph num="(4)"> <text>The rehabilitation coordinator shall document that the minor's needs and progress are promptly communicated to:</text> <paragraph num="(a)"> <text>Staff involved in the implementation of the IRP or ITRP; and</text> </paragraph> <paragraph num="(b)"> <text>The minor's parent or guardian, if appropriate; and</text> </paragraph> <paragraph num="(c)"> <text>With proper consent, other community mental health programs providing services to the minor.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rehabilitation and Support Services Provided."> <paragraph num="A."> <text>PRP services may only be provided to a minor if identified in the minor's IRP and referred for PRP services by:</text> <paragraph num="(1)"> <text>A licensed mental health professional who is providing inpatient, residential treatment center, or outpatient mental health services to the minor; and</text> </paragraph> <paragraph num="(2)"> <text>Staff who have been privileged by the program to provide the services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Rehabilitation Activities. The program director shall ensure that the program provides rehabilitation activities directed toward the development or restoration of skills including:</text> <paragraph num="(1)"> <text>Age-appropriate self care skills, including:</text> <paragraph num="(a)"> <text>Personal hygiene;</text> </paragraph> <paragraph num="(b)"> <text>Grooming;</text> </paragraph> <paragraph num="(c)"> <text>Nutrition;</text> </paragraph> <paragraph num="(d)"> <text>Dietary planning;</text> </paragraph> <paragraph num="(e)"> <text>Food preparation; and</text> </paragraph> <paragraph num="(f)"> <text>Self-administration of medication;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Social skills, including community integration activities, developing natural supports, and developing linkages with and supporting the minor's participation in community activities;</text> </paragraph> <paragraph num="(3)"> <text>Independent living skills, including:</text> <paragraph num="(a)"> <text>Maintenance of the minor's living environment;</text> </paragraph> <paragraph num="(b)"> <text>Community awareness;</text> </paragraph> <paragraph num="(c)"> <text>Mobility skills;</text> </paragraph> <paragraph num="(d)"> <text>Money management; and</text> </paragraph> <paragraph num="(e)"> <text>Accessing available entitlements;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Activities that support the minor's cultural interests;</text> </paragraph> <paragraph num="(5)"> <text>Conflict resolution;</text> </paragraph> <paragraph num="(6)"> <text>Anger management;</text> </paragraph> <paragraph num="(7)"> <text>Interactive skills with peers and authority figures;</text> </paragraph> <paragraph num="(8)"> <text>Maintaining personal living space;</text> </paragraph> <paragraph num="(9)"> <text>Maintaining age-appropriate boundaries;</text> </paragraph> <paragraph num="(10)"> <text>Maintaining personal safety in a social environment; and</text> </paragraph> <paragraph num="(11)"> <text>Time management, including constructive use of structured and unstructured time.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medication Services.</text> <paragraph num="(1)"> <text>Administration.</text> <paragraph num="(a)"> <text>An individual licensed to administer medication under Health Occupations Article, Annotated Code of Maryland, may do so.</text> </paragraph> <paragraph num="(b)"> <text>A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Monitoring. A PRP staff member shall provide the following services:</text> <paragraph num="(a)"> <text>Support the individual's self-administration, as appropriate, of prescribed medication;</text> </paragraph> <paragraph num="(b)"> <text>Read the medication label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date;</text> </paragraph> <paragraph num="(c)"> <text>To the extent possible, monitor compliance with instructions appearing on the medication label;</text> </paragraph> <paragraph num="(d)"> <text>Ensure that each individual has secure, appropriate, and accessible space in which to store medications;</text> </paragraph> <paragraph num="(e)"> <text>Observe and document any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicate to the prescribing authority any problems that possibly may be related to the medication; and</text> </paragraph> <paragraph num="(f)"> <text>Reinforce, with the individual, education on the role and effects of medication in symptom management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Promotion of Illness Self Management.</text> <paragraph num="(1)"> <text>As is age appropriate, staff shall provide education and information regarding mental illness.</text> </paragraph> <paragraph num="(2)"> <text>The program director shall ensure that the minor's rehabilitation coordinator collaborates with the minor to identify effective strategies to assist the minor to manage the minor's illness.</text> </paragraph> <paragraph num="(3)"> <text>The strategies identified under §D(2) shall include, at a minimum, the minor's identification of:</text> <paragraph num="(a)"> <text>Potential problematic symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Warning signs of relapse;</text> </paragraph> <paragraph num="(c)"> <text>Helpful interventions; and</text> </paragraph> <paragraph num="(d)"> <text>Other individuals the minor identifies to resolve the situation in order for the minor to remain in service or to seek treatment.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The minor's illness self management strategies shall be documented and may be incorporated in the minor's IRP, ITP, mental health advance directive, or any combination of them.</text> </paragraph> <paragraph num="(5)"> <text>The strategies shall be reviewed at the time of the IRP review and may be revised or revoked at any time at the request of the minor.</text> </paragraph> </paragraph> <paragraph num="E."> <text>On-Call and Emergency Response. The program director shall assure that:</text> <paragraph num="(1)"> <text>On-call and emergency response services are available by a licensed mental health professional to an individual who has been admitted to the PRP:</text> <paragraph num="(a)"> <text>Face-to-face during the hours that the PRP is open; and</text> </paragraph> <paragraph num="(b)"> <text>By telephone, on an on-call basis, 24 hours per day, 7 days per week, during the hours the PRP is not open:</text> <paragraph num="(i)"> <text>Through the PRP; or</text> </paragraph> <paragraph num="(ii)"> <text>Through an agreement with another mental health crisis service provider;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>PRP staff provide to a minor:</text> <paragraph num="(a)"> <text>Intensive support and assistance, as authorized, including but not limited to:</text> <paragraph num="(i)"> <text>Providing one-to-one staff support for the minor, if necessary;</text> </paragraph> <paragraph num="(ii)"> <text>Escorting the minor while accessing needed assistance or services; and</text> </paragraph> <paragraph num="(iii)"> <text>Obtaining input from the mental health professional who is providing outpatient mental health services to the minor;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Information regarding needed services; and</text> </paragraph> <paragraph num="(c)"> <text>If necessary, referral for appropriate health care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>If emergency care is necessary, all relevant staff shall:</text> <paragraph num="(1)"> <text>Have access to the names, addresses, and telephone numbers of providers, including the hospital, that are designated to provide emergency care and treatment to the minors served; and</text> </paragraph> <paragraph num="(2)"> <text>Be appropriately trained to link minors to emergency care, as needed.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Linkage with a Minor in a Psychiatric Inpatient Facility, Residential Treatment Center (RTC), or Detention Center.</text> <paragraph num="(1)"> <text>If a minor who is enrolled in a program is admitted to a psychiatric inpatient facility, RTC, or detention center, the rehabilitation coordinator shall make reasonable efforts to maintain ongoing communication with the minor and the minor's inpatient treatment team.</text> </paragraph> <paragraph num="(2)"> <text>To the degree permitted by the setting, PRP staff serving the minor shall participate in aftercare or release planning from that setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Discharge from Services."> <text>The program director shall maintain clearly written policies and procedures, which may be contained in one document, for the process for discharge from the program as outlined in COMAR 10.21.17.11.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Program Staff."> <paragraph num="A."> <text>Following an analysis of the complexity and number of minors served, the program director, with input from program staff, shall ensure the development of a staffing plan that identifies the type and number of staff needed to implement the program's rehabilitation service goals.</text> </paragraph> <paragraph num="B."> <text>A provider shall ensure that the staff includes the following, who are employed by the PRP for the amounts of time outlined in §§C — E of this regulation:</text> <paragraph num="(1)"> <text>A program director, who:</text> <paragraph num="(a)"> <text>Is qualified according to §F(1) of this regulation and who is responsible for the duties under §F(2) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>May be responsible for the duties of the rehabilitation specialist under §G(1)(b) of this regulation, if the program director:</text> <paragraph num="(i)"> <text>Is qualified according to §G(1)(a) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Devotes the time required, under §C, D, or E of this regulation, to the development and implementation of rehabilitation services that reflect the need of the minors served by the program;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>As required under §C, D, or E of this regulation, a rehabilitation specialist or specialists, qualified according to §G(1)(a) of this regulation, to carry out the duties under §G(1)(b) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>As required under §D or E of this regulation, staff designated to carry out administrative duties assigned by the program director.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a PRP has fewer than 30 enrollees, the PRP shall employ either:</text> <paragraph num="(1)"> <text>A program director and a rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week; or</text> </paragraph> <paragraph num="(2)"> <text>A program director who is responsible for the duties of the program director and the duties of a rehabilitation specialist, if the program director:</text> <paragraph num="(a)"> <text>Has the qualifications described under §G(1)(a) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by the program for 40 hours per week; and</text> </paragraph> <paragraph num="(c)"> <text>Devotes at least 20 hours per week to the development and implementation of rehabilitation services that reflect the needs of the minors served by the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If a PRP has 30 — 100 enrollees, the PRP shall employ either:</text> <paragraph num="(1)"> <text>A program director, who is employed by the program for a minimum of 20 hours per week, and a rehabilitation specialist, who is employed by the program for a minimum of 40 hours per week; or</text> </paragraph> <paragraph num="(2)"> <text>A program director who is responsible for the duties of the program director and the duties of a rehabilitation specialist, if the program director:</text> <paragraph num="(a)"> <text>Has the qualifications described under §G(1)(a) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Is employed by the program for 40 hours per week; and</text> </paragraph> <paragraph num="(c)"> <text>Designates staff who devote 20 hours per week to carrying out specific assigned administrative duties.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>If a PRP has more than 100 enrollees, the PRP program shall employ:</text> <paragraph num="(1)"> <text>A program director who is employed by the program for 40 hours per week; and</text> </paragraph> <paragraph num="(2)"> <text>A rehabilitation specialist or specialists and staff assigned to administrative duties, as follows:</text> <paragraph num="(a)"> <text>A rehabilitation specialist who is employed by the program for 40 hours per week;</text> </paragraph> <paragraph num="(b)"> <text>Two rehabilitation specialists, each of whom is employed by the program for 20 hours per week; or</text> </paragraph> <paragraph num="(c)"> <text>If the program director has the qualifications described under §G(1)(a) of this regulation:</text> <paragraph num="(i)"> <text>A rehabilitation specialist who is employed by the program for 20 hours per week; and</text> </paragraph> <paragraph num="(ii)"> <text>Designated staff who devote 20 hours per week to carrying out specific assigned administrative duties.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Program Director. The program director:</text> <paragraph num="(1)"> <text>Shall have:</text> <paragraph num="(a)"> <text>Sufficient qualifications, knowledge, and experience to execute the duties of the position; and</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 3 years experience working with emotionally disturbed youth; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is responsible for administrative oversight of the PRP, including, at a minimum:</text> <paragraph num="(a)"> <text>Fulfilling the administrative requirements under COMAR 10.21.17;</text> </paragraph> <paragraph num="(b)"> <text>Fulfilling the programmatic requirements of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Keeping the advisory committee, or governing body, whichever is applicable, informed of, at a minimum, the program's approval status and performance; and</text> </paragraph> <paragraph num="(d)"> <text>Quality management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Psychiatric Rehabilitation Staff. The program director shall employ psychiatric rehabilitation staff, including:</text> <paragraph num="(1)"> <text>At least one rehabilitation specialist who:</text> <paragraph num="(a)"> <text>Is a licensed mental health professional with a minimum of 2 years direct care experience working with emotionally disturbed youth;</text> </paragraph> <paragraph num="(b)"> <text>Shall advise the program director regarding development and implementation of rehabilitation services that reflect the need of the minors served by the program;</text> </paragraph> <paragraph num="(c)"> <text>Has overall responsibility for rehabilitation services, including:</text> <paragraph num="(i)"> <text>Developing and assuring that rehabilitation services meet the needs of the individuals served by the program; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing oversight for the daily program of rehabilitation services; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Shall educate direct care staff on how to document the correlation between rehabilitation activities and the goals identified in the IRP or ITRP;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Direct service staff who:</text> <paragraph num="(a)"> <text>Are supervised by a licensed mental health professional or a rehabilitation specialist;</text> </paragraph> <paragraph num="(b)"> <text>Have 60 hours of on-the-job direct PRP supervision before providing services to minors served by the program without direct supervision;</text> </paragraph> <paragraph num="(c)"> <text>At a minimum, have:</text> <paragraph num="(i)"> <text>A bachelor's degree in a health-related field;</text> </paragraph> <paragraph num="(ii)"> <text>An associate's degree in a health-related field;</text> </paragraph> <paragraph num="(iii)"> <text>30 hours, or their equivalent, of college credit toward a bachelor's degree in a health-related field; or</text> </paragraph> <paragraph num="(iv)"> <text>1 year of work experience in a supervised mental health setting; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Are responsible for implementing the rehabilitation activities outlined in the minor's IRP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Ratio.</text> <paragraph num="(1)"> <text>The program shall maintain an average ratio of at least one rehabilitation staff member serving each six minors who are either attending the PRP facility or receiving off-site services.</text> </paragraph> <paragraph num="(2)"> <text>To achieve this ratio, the program:</text> <paragraph num="(a)"> <text>May not include:</text> <paragraph num="(i)"> <text>The program director; or</text> </paragraph> <paragraph num="(ii)"> <text>Volunteers; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May include students only if, in calculating the ratio, three rehabilitation staff are on duty for each student.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Students. The program may use students according to the provisions of COMAR 10.21.17.11E.</text> </paragraph> <paragraph num="J."> <text>Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.11F.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 2006 (33:7 Md. R. 669)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="30" heading="Telemental Health Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to public mental health system (PMHS) outpatient mental health centers (OMHC) or individual psychiatrists to provide psychiatric consultation, evaluation, and ongoing treatment, via interactive video telemental health (TMH) technologies to eligible individuals:</text> <paragraph num="(1)"> <text>Located in designated rural geographic areas of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>For whom personal psychiatric services are not available.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The purpose of providing psychiatric care via TMH technology is to:</text> <paragraph num="(1)"> <text>Improve access to outpatient psychiatric care, thus reducing the individual's admission to emergency rooms, inpatient facilities, or detention centers;</text> </paragraph> <paragraph num="(2)"> <text>Improve access to outpatient and inpatient psychiatric subspeciality consultation, thus improving diagnostic clarification, treatment recommendations, and planning for the individual; and</text> </paragraph> <paragraph num="(3)"> <text>Improve capacity and choice for outpatient ongoing psychiatric treatment, thus reducing the need to travel outside the community when local resources are limited.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Critical access hospital” means a hospital that is certified to receive cost-based reimbursement from Medicare.</text> </paragraph> <paragraph num="(2)"> <text>“Designated rural geographic areas” means the rural geographical areas in Maryland identified by the Department that typically have mental health needs that have limited local mental health resource capacity or specialty psychiatric care.</text> </paragraph> <paragraph num="(3)"> <text>“Distant site” means the site at which the psychiatrist is located at the time the mental health service is provided via a telecommunications system.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency department services” means initial hospital services provided to individuals with a broad spectrum of illnesses and injuries, some of which may be life-threatening and requiring immediate attention.</text> </paragraph> <paragraph num="(5)"> <text>“Federally qualified health center” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Individual practitioner” means a psychiatrist who is licensed to practice psychiatry in Maryland, and either:</text> <paragraph num="(a)"> <text>Is certified in psychiatry by the American Board of Psychiatry and Neurology; or</text> </paragraph> <paragraph num="(b)"> <text>Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in Neurology.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Not available” means that the PMHS administrative services organization certifies that the individual cannot access psychiatric services.</text> </paragraph> <paragraph num="(8)"> <text>“Originating site” means a site that has been approved by the Department to provide TMH services, at which an eligible individual is located at the time the service is delivered via a telecommunications system.</text> </paragraph> <paragraph num="(9)"> <text>“Originating site fee” means the amount the Department reimburses an approved TMH originating site.</text> </paragraph> <paragraph num="(10)"> <text>“Professional fee” means the amount the Department reimburses an approved TMH distant facility or licensed individual mental health professional:</text> <paragraph num="(a)"> <text>For a clinical care opinion, treatment, or both;</text> </paragraph> <paragraph num="(b)"> <text>To purchase, install, and maintain video conferencing equipment;</text> </paragraph> <paragraph num="(c)"> <text>To pay for line or per minute usage charges, or both; and</text> </paragraph> <paragraph num="(d)"> <text>For any additional programmatic, administrative, clinical, or contingency support at the distant site.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Public Mental Health System (PMHS).</text> <paragraph num="(a)"> <text>“Public mental health system” means the system for the delivery of mental health treatment and supports to individuals who meet medical necessity criteria and financial eligibility as established by the Administration.</text> </paragraph> <paragraph num="(b)"> <text>“Public mental health system” includes the specialty mental health system described in COMAR 10.09.70.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Rural health clinic” means a facility that meets the definition of a rural health clinic as contained in 42 CFR §491.2(f), as amended.</text> </paragraph> <paragraph num="(13)"> <text>“Security” means the protection of information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction.</text> </paragraph> <paragraph num="(14)"> <text>“Telemental Health (TMH)” means the delivery of mental health care at a distance through the use of technology-assisted communication.</text> </paragraph> <paragraph num="(15)"> <text>“Telepresenter” means the individual at the originating site who introduces the patient to the distant site provider for examination, and to whom the distant site provider may delegate tasks and activities, and who is:</text> <paragraph num="(a)"> <text>A licensed independent practitioner; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed or certified to perform health care services by licensing, training, or experience for the performance of the task or activity as long as the task or activity does not require the exercise of independent medical judgment for its performance.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Telepresenter fee” means the amount the Department reimburses a licensed, independent provider to present an individual to the TMH provider, due to medical necessity, to successfully complete the examination.</text> </paragraph> <paragraph num="(17)"> <text>“Virtual private network connection” means a method of connecting to a private network via a public network.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval."> <text>The Department shall grant approval to a TMH provider to be eligible to receive State or federal funds for providing interactive TMH services if the TMH provider meets the requirements of this chapter and:</text> <paragraph num="A."> <text>For outpatient mental health centers, COMAR 10.21.20; or</text> </paragraph> <paragraph num="B."> <text>If the TMH provider is an individual psychiatrist, COMAR 10.09.36.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Service Model."> <paragraph num="A."> <text>TMH provides the opportunity for community-based medical and mental health providers to access general or subspecialty psychiatric care providers from other areas of the State.</text> </paragraph> <paragraph num="B."> <text>TMH providers may be private practice, part of a hospital, academic, health, or mental health care system.</text> </paragraph> <paragraph num="C."> <text>PMHS approved community-based providers or individual practitioners may engage in agreements with TMH providers for services.</text> </paragraph> <paragraph num="D."> <text>Fee-for-service reimbursement shall be at an enhanced rate, as stipulated by the Department, provided all applicable provisions of this chapter are met and funds are available.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility."> <paragraph num="A."> <text>Individual Eligibility. An individual is eligible to receive TMH services if the individual:</text> <paragraph num="(1)"> <text>Is Medicaid eligible;</text> </paragraph> <paragraph num="(2)"> <text>Meets the eligibility and medical necessity criteria for participation in the Public Mental Health System;</text> </paragraph> <paragraph num="(3)"> <text>Resides in one of the designated rural geographic areas or whose situation makes person-to-person psychiatric services unavailable; and</text> </paragraph> <paragraph num="(4)"> <text>Voluntarily consents to TMH services, which shall be documented in the individual's medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individual Provider Eligibility. A provider of TMH services shall be a psychiatrist who:</text> <paragraph num="(1)"> <text>Has an active:</text> <paragraph num="(a)"> <text>License to practice psychiatry in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Medicaid provider number;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complies with professional practice standards; and</text> </paragraph> <paragraph num="(3)"> <text>Completes a registration to provide TMH health services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Originating Site Facility Eligibility. The following Maryland sites may be approved as an originating site for THM health service delivery:</text> <paragraph num="(1)"> <text>County government offices appropriate for private clinical evaluation services;</text> </paragraph> <paragraph num="(2)"> <text>Critical Access Hospital;</text> </paragraph> <paragraph num="(3)"> <text>Federally Qualified Health Center;</text> </paragraph> <paragraph num="(4)"> <text>Hospital;</text> </paragraph> <paragraph num="(5)"> <text>Outpatient mental health center;</text> </paragraph> <paragraph num="(6)"> <text>Physician's office;</text> </paragraph> <paragraph num="(7)"> <text>Rural Health Clinic;</text> </paragraph> <paragraph num="(8)"> <text>Elementary, middle, high, or technical school with a supported nursing, counseling or medical office; or</text> </paragraph> <paragraph num="(9)"> <text>College or university student health or counseling office.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Distant Site Location Eligibility. An approved distant TMH location shall be within the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Technical Requirements."> <text>A provider of TMH health services shall have video technology components as follows:</text> <paragraph num="A."> <text>A minimum bandwidth of 384 KBPS (H.263), 256 KBPS (H.264), or technical equivalent;</text> </paragraph> <paragraph num="B."> <text>A monitor with a:</text> <paragraph num="(1)"> <text>Minimum net display of 16" diagonally; and</text> </paragraph> <paragraph num="(2)"> <text>Non-anamorphic video picture display;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A minimum video resolution of 1 Common Intermediate Format (CIF), or 1 Source Input Format (SIF);</text> </paragraph> <paragraph num="D."> <text>Internet protocol sessions that are encrypted unless they are conducted entirely on a protected network, or using a virtual private network connection; and</text> </paragraph> <paragraph num="E."> <text>A camera at the originating site, that has pan, tilt, and zoom capabilities that can be remotely controlled from the distant site.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality."> <text>All originating and distant TMH sites shall comply with the rules and regulations concerning the privacy and security of protected health information under:</text> <paragraph num="A."> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320D et seq., as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Medical Records."> <paragraph num="A."> <text>Originating Site. The originating site shall:</text> <paragraph num="(1)"> <text>Be responsible for maintaining a complete medical record as if the individual were seen face-to-face at the originating site;</text> </paragraph> <paragraph num="(2)"> <text>Meet the facility and community standard for medical record completion and retention, including applicable record reviews; and</text> </paragraph> <paragraph num="(3)"> <text>Be responsible for any proper release of information contained in an individual's medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Distant Site.</text> <paragraph num="(1)"> <text>The distant site shall maintain copies of all documentation completed by the distant site TMH provider unless the distant site TMH provider enters the information directly into the originating site's electronic medical record system.</text> </paragraph> <paragraph num="(2)"> <text>The distant site, as part of its quality improvement system, shall have a process to review TMH care.</text> </paragraph> <paragraph num="(3)"> <text>As part of quality monitoring, when the originating site's electronic medical records are reviewed at the distant site, the:</text> <paragraph num="(a)"> <text>Review may include the TMH provider's documentation online, if authorized; or</text> </paragraph> <paragraph num="(b)"> <text>Distant site may request sections of the individual's electronic medical record from the originating site for the distant site peer review.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>TMH records shall be retained according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Covered Services."> <paragraph num="A."> <text>TMH services shall be authorized by the Administration's administrative service organization.</text> </paragraph> <paragraph num="B."> <text>The Department shall reimburse an approved TMH provider for rendering the following psychiatric services to an eligible child, adolescent, or adult via a telecommunications system:</text> <paragraph num="(1)"> <text>Diagnostic interview;</text> </paragraph> <paragraph num="(2)"> <text>Individual therapy, with or without medication evaluation and management;</text> </paragraph> <paragraph num="(3)"> <text>Family therapy, with or without the identified patient;</text> </paragraph> <paragraph num="(4)"> <text>Group therapy for each individual, up to a maximum of 8 individuals;</text> </paragraph> <paragraph num="(5)"> <text>Outpatient evaluation and management for a new or established patient;</text> </paragraph> <paragraph num="(6)"> <text>Outpatient office consultation for a new or established patient;</text> </paragraph> <paragraph num="(7)"> <text>Initial inpatient consultation for a new or established patient; and</text> </paragraph> <paragraph num="(8)"> <text>Emergency department services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reimbursement."> <paragraph num="A."> <text>There are three categories of fees that the Department shall reimburse an approved TMH provider, as applicable:</text> <paragraph num="(1)"> <text>Originating site fee;</text> </paragraph> <paragraph num="(2)"> <text>Professional fee; and</text> </paragraph> <paragraph num="(3)"> <text>Telepresenter fee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Originating Site Fee.</text> <paragraph num="(1)"> <text>The originating site facility fee is set forth by the Center for Medicare and Medicaid Services, published annually and included in the Medicare Physician Fee Schedule Final Rule, issued by November 1, prior to the start of the calendar year for which it is effective.</text> </paragraph> <paragraph num="(2)"> <text>Originating sites only may file for reimbursement and shall use the appropriate code modifier.</text> </paragraph> <paragraph num="(3)"> <text>Fees paid to the originating site may be used to:</text> <paragraph num="(a)"> <text>Purchase, install, and maintain video conferencing equipment;</text> </paragraph> <paragraph num="(b)"> <text>Pay for line or per minute usage charges, or both; and</text> </paragraph> <paragraph num="(c)"> <text>Any additional programmatic, administrative, clinical or contingency support at the originating site.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Professional Fee. Professional Fee for individual providers or OMHC providing TMH is set forth in COMAR 10.21.25.</text> </paragraph> <paragraph num="D."> <text>Telepresenter Fee. Telepresenter Fees for assisting in TMH are set forth in 10.21.25 and subject to the following requirements prior to billing:</text> <paragraph num="(1)"> <text>A telepresenter fee is applicable only when, due to medical necessity, a licensed independent practitioner is required to present the individual to the distant provider to successfully complete the examination;</text> </paragraph> <paragraph num="(2)"> <text>Fees for telepresenters that are not licensed independent practitioners, and fees for telepresenters that are licensed independent practitioners, but their presence is not medically necessary, are included as part of the originating site facility fee; and</text> </paragraph> <paragraph num="(3)"> <text>The distant provider shall clearly document in the individual's medical record the rationale requiring the involvement of the licensed independent practitioner, as medically necessary, at any particular session.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §10-901, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 6, 2010 (37:18 Md. R. 1214)</annotation> </annotations> </chapter> <chapter num="31" heading="Maryland Mental Health AND Substance Use Disorder Registry and Referral System"> <regulation prefix="Regulation" num=".01" heading="Purpose and Effective Date."> <text>Effective January 27, 2023, there is a Maryland Mental Health and Substance Use Disorder Registry and Referral System to provide a statewide system through which health care providers can identify and access available inpatient and outpatient mental health and substance use services for patients in a seamless manner.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>Hospitals under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Freestanding medical facilities under Health-General Article, Title 19, Subtitle 3(a), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>Any other provider type designated by the Department by issuance of a transmittal sent to all designated providers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Facility” means a hospital, freestanding medical facility, or provider designated by the Department.</text> </paragraph> <paragraph num="(3)"> <text>“Hospital” means a general or special hospital licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and COMAR 10.07.01.</text> </paragraph> <paragraph num="(4)"> <text>“Maryland Mental Health and Substance Use Disorder Registry and Referral System” or “Bed Registry and Referral System” means the system operated by the Department through which health care providers can identify and access available inpatient and outpatient mental health and substance use services for patients.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Use."> <text>A facility shall:</text> <paragraph num="A."> <text>Refer an individual who may require additional care coordination for inpatient, outpatient, or community-based behavioral health services, after undergoing an initial psychiatric evaluation, no later than 48 hours after arrival at the facility at a phone number or website address designated by the Department through written directives to implement the Bed Registry and Referral System; and</text> </paragraph> <paragraph num="B."> <text>Provide all necessary patient information, including, but not limited to, diagnosis and level of care recommendations to the respective care coordination centers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Daily Reporting."> <text>A facility shall report current bed availability and census information, and any additional relevant information requested by the Department, to populate the inpatient psychiatric bed board as necessary to keep the information updated, but not less than three times per day, during the following periods:</text> <paragraph num="A."> <text>9 a.m. to 12 p.m.;</text> </paragraph> <paragraph num="B."> <text>1 p.m. to 3 p.m.; and</text> </paragraph> <paragraph num="C."> <text>4 p.m. to 7 p.m.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalties."> <paragraph num="A."> <text>A hospital that violates this chapter is subject to the fines, penalties, and actions specified in Health-General Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A provider who violates this chapter is subject to the fines, penalties, and actions specified in Health-General Article, Title 7.5, Annotated Code of Maryland, and COMAR 10.63.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7.5-802, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective January 27, 2023 (50:4 Md. R. 119); expired effective July 26, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted effective June 24, 2024 (51:12 Md. R. 619)</annotation> </annotations> </chapter> </subtitle> <subtitle num="22" heading="Developmental Disabilities"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Developmental Disabilities Administration of the Maryland Department.</text> </paragraph> <paragraph num="(2)"> <text>“Alternative living unit (ALU)” means a residence owned, leased, or operated by a licensee that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits not more than 3 individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per unit, per week.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Assistive technology” means the technology necessary to enable the individual to live successfully in the community.</text> </paragraph> <paragraph num="(4)"> <text>“Aversive technique” means the use of painful or noxious stimuli to the body, which is intrusive to the individual's physical, mental, or emotional well-being, used to terminate challenging or maladaptive behavior.</text> </paragraph> <paragraph num="(5)"> <text>“Barrier” means an obstacle preventing or inhibiting an individual from receiving services and supports in the most integrated setting appropriate to meet the individual's needs.</text> </paragraph> <paragraph num="(6)"> <text>“Behavior plan (BP)” means a plan designed to modify behavior through the use of clinically accepted techniques.</text> </paragraph> <paragraph num="(7)"> <text>Behavioral Consultation.</text> <paragraph num="(a)"> <text>“Behavioral consultation” means on-site observation, assessment, and evaluation of the interaction between the individual and the individual's caregiver in the context of the individual's existing programs.</text> </paragraph> <paragraph num="(b)"> <text>“Behavioral consultation” includes:</text> <paragraph num="(i)"> <text>Recommendations regarding the structure of the program and appropriate activities and services; and</text> </paragraph> <paragraph num="(ii)"> <text>Consultation, as needed, with clinical professionals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Behavioral emergency” means a situation in which an individual's behavior appears to present imminent danger to the individual or to others.</text> </paragraph> <paragraph num="(9)"> <text>“Behavioral respite” means relief services provided by a community residential licensee to meet an individual's behavioral needs.</text> </paragraph> <paragraph num="(10)"> <text>“Care provider” means an individual who is responsible for the daily operation of an individual family care home as defined in §B(26) of this regulation.</text> </paragraph> <paragraph num="(11)"> <text>“Challenging behavior” means those behaviors exhibited by an individual which:</text> <paragraph num="(a)"> <text>Are harmful, destructive, or socially unacceptable; and</text> </paragraph> <paragraph num="(b)"> <text>Necessitate being addressed in the individual's individual plan.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Chemical restraint” means the use of an injectable medication as an intervention in a behavioral emergency.</text> </paragraph> <paragraph num="(13)"> <text>“Community supported living arrangement home” means a residence:</text> <paragraph num="(a)"> <text>Which is rented or owned by an individual or the individual's family or proponent or held in trust for an individual;</text> </paragraph> <paragraph num="(b)"> <text>Where an individual lives as a roommate without the individual's name appearing on the lease or title; or</text> </paragraph> <paragraph num="(c)"> <text>Where the licensee is the guarantor of rental or mortgage payments for an individual receiving CSLA services.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Community Supported Living Arrangements.</text> <paragraph num="(a)"> <text>“Community supported living arrangements (CSLA)” means services to assist an individual in nonvocational activities necessary to enable that individual to live in the individual's own home, apartment, family home, or rental unit, with:</text> <paragraph num="(i)"> <text>No more than two other nonrelated recipients of these services; or</text> </paragraph> <paragraph num="(ii)"> <text>Members of the same family regardless of their number.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Community supported living arrangements (CSLA)” includes personal support services, as defined under the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services, including but not limited to the following services:</text> <paragraph num="(i)"> <text>Personal assistance services;</text> </paragraph> <paragraph num="(ii)"> <text>Supports that enhance the individual’s opportunity for community participation and to exercise choice and control over the individual’s own life;</text> </paragraph> <paragraph num="(iii)"> <text>Training, habilitation, and other services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity; and</text> </paragraph> <paragraph num="(iv)"> <text>24-hour emergency assistance.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Community supported living arrangements (CSLA)” also includes other services set forth in the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services as distinct from personal support services, including but not limited to the following:</text> <paragraph num="(i)"> <text>Assistive technology;</text> </paragraph> <paragraph num="(ii)"> <text>Adaptive equipment;</text> </paragraph> <paragraph num="(iii)"> <text>Resource coordination;</text> </paragraph> <paragraph num="(iv)"> <text>Environmental modifications;</text> </paragraph> <paragraph num="(v)"> <text>Respite; and</text> </paragraph> <paragraph num="(vi)"> <text>Other services as approved by the Secretary or the Secretary’s designee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(16)"> <text>“Developmental disability” means a severe chronic disability of an individual that:</text> <paragraph num="(a)"> <text>Is attributable to a physical or mental impairment, other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments;</text> </paragraph> <paragraph num="(b)"> <text>Is likely to continue indefinitely;</text> </paragraph> <paragraph num="(c)"> <text>Is manifested in an individual younger than 22 years old;</text> </paragraph> <paragraph num="(d)"> <text>Results in an inability to live independently without external support or continuing and regular assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Director” means Director of the Developmental Disabilities Administration or the Director's designee.</text> </paragraph> <paragraph num="(18)"> <text>“Eligible for individual support services” means an individual with a severe chronic disability that is:</text> <paragraph num="(a)"> <text>Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and</text> </paragraph> <paragraph num="(b)"> <text>Likely to continue indefinitely.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Environmental modification” means physical adaptations to an individual's home that are provided to enable the individual to live safely at home.</text> </paragraph> <paragraph num="(20)"> <text>“Foreign corporation” means an entity that is properly organized, chartered, and incorporated under the laws of a state other than Maryland.</text> </paragraph> <paragraph num="(20-1)"> <text>“Forensic residential center (FRC)” means a facility that is:</text> <paragraph num="(a)"> <text>Licensed to provide a continuum of integrative services to individuals with intellectual disabilities:</text> <paragraph num="(i)"> <text>Ordered by the court for an evaluation or to be confined;</text> </paragraph> <paragraph num="(ii)"> <text>Court-committed for care or treatment to the Department as incompetent to stand trial or not criminally responsible who are dangerous as a result of intellectual disabilities; or</text> </paragraph> <paragraph num="(iii)"> <text>On conditional release and returned to the facility either voluntarily or on hospital warrant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A related institution as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Not an extended care or comprehensive rehabilitation facility.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Functional analysis” means a method of investigation which involves the systematic, experimental manipulation of analogue conditions, and precise measurement of challenging behavior, in order to determine the behavioral consequences which maintain the challenging behavior.</text> </paragraph> <paragraph num="(22)"> <text>“Functional assessment” means a nonexperimental method, such as systematic observations and questionnaires, designed to assist in the formulation of an educated guess concerning the behavioral consequences which maintain challenging behavior.</text> </paragraph> <paragraph num="(23)"> <text>“Generic services” means services which are available to the community at large.</text> </paragraph> <paragraph num="(24)"> <text>“Goal” means measurable supports or training to achieve an outcome.</text> </paragraph> <paragraph num="(25)"> <text>“Group home” means a residence owned, leased, or operated by a licensee that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits at least four, but not more than eight individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per week.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Individual” means a person eligible to receive services from the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(27)"> <text>“Individual family care (IFC) home” means a private, single family residence which provides a home for up to three individuals with developmental disabilities, who are unrelated to the care provider.</text> </paragraph> <paragraph num="(28)"> <text>“Individual plan (IP)” means a plan that specifies assessments, services, supports, and training required by the individual.</text> </paragraph> <paragraph num="(29)"> <text>“Integrated work setting” means an environment in which individuals with developmental disabilities and individuals without developmental disabilities work together.</text> </paragraph> <paragraph num="(30)"> <text>“Licensed capacity” means the number of individuals for whom a licensee is authorized to provide services at a single site.</text> </paragraph> <paragraph num="(31)"> <text>“Licensed certified social worker” means a person authorized to practice social work under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Licensed health care practitioner” means a person licensed to provide health care within the scope of Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Licensed or certified professional counselor” means a person who is authorized to practice professional counseling under Health Occupations Article, Title 17, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Licensed physician” means a person who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(35)"> <text>“Licensed psychologist” means a person who is authorized to practice psychology under Health Occupations Article, Title 18, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(36)"> <text>“Licensee” means an agency that has been granted a license by the Administration to provide services to individuals.</text> </paragraph> <paragraph num="(37)"> <text>“Management of disruptive behavior” means the Administration-approved curriculum for managing challenging or aggressive behavior.</text> </paragraph> <paragraph num="(38)"> <text>“Mechanical restraint” means a mechanical device which restricts the free movement of an individual, such as a safety coat or posey mittens.</text> </paragraph> <paragraph num="(39)"> <text>“Mechanical support” means a mechanical device used to:</text> <paragraph num="(a)"> <text>Support an individual's proper body position, balance, or alignment, such as splints, wedges, bolsters, or lap trays; or</text> </paragraph> <paragraph num="(b)"> <text>Protect an individual with a continuing medical condition from sustaining an injury, for example, the use of protective head gear for an individual with epilepsy.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>“Most integrated setting” means a setting that enables an individual with a disability to interact with nondisabled individuals other than staff to the fullest extent possible.</text> </paragraph> <paragraph num="(41)"> <text>“Natural supports” means family, friends, co-workers, and community members who provide informal assistance to the individual to enable the individual to live and work in the community.</text> </paragraph> <paragraph num="(42)"> <text>“Outcome” means tangible results of goals that reflect the desired quality of life as defined by the individual.</text> </paragraph> <paragraph num="(43)"> <text>“Personal assistance” means help with activities of daily living which does not have an habilitation objective.</text> </paragraph> <paragraph num="(44)"> <text>“Physical restraint” means a manual method used to restrict the free movement of an individual, such as therapeutic hold.</text> </paragraph> <paragraph num="(45)"> <text>“Plan of correction (POC)” means the licensee's proposed response to findings of noncompliance identified by the Licensing and Certification Administration or the Administration.</text> </paragraph> <paragraph num="(46)"> <text>“PRN orders” means a preauthorized order to administer a specific behavior management technique or medication to modify behavior which is administered on an as-needed basis when a challenging behavior is exhibited.</text> </paragraph> <paragraph num="(47)"> <text>“Program service plan (PSP)” means the document submitted as part of the licensure application that delineates the rationale, scope, staffing, training, setting, and location for the services or supports to be provided.</text> </paragraph> <paragraph num="(48)"> <text>“Proponent” means a person who has a legitimate interest in the welfare of an individual receiving services from a licensee.</text> </paragraph> <paragraph num="(49)"> <text>“Psychology associate” means a person who may perform psychological services under certain conditions as specified in Health Occupations Article, Title 18, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(50)"> <text>“Record” means the cumulative body of information the licensee has on file regarding an individual.</text> </paragraph> <paragraph num="(51)"> <text>“Resource coordinator” means a professional:</text> <paragraph num="(a)"> <text>Designated by the Developmental Disabilities Administration;</text> </paragraph> <paragraph num="(b)"> <text>Not employed by a direct service provider;</text> </paragraph> <paragraph num="(c)"> <text>Who has knowledge and experience in community supports for individuals with developmental disabilities; and</text> </paragraph> <paragraph num="(d)"> <text>Who meets the requirements of COMAR 10.22.09.</text> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Respite” means relief services provided to the family or care provider to meet planned or emergency situations.</text> </paragraph> <paragraph num="(53)"> <text>“Restrictive technique” means a technique that is implemented to impede an individual's physical mobility or limit free access to the environment, including but not limited to physical, mechanical, or chemical restraints or medications used to modify behavior.</text> </paragraph> <paragraph num="(54)"> <text>“Seclusion” means the involuntary placement of an individual alone in a room.</text> </paragraph> <paragraph num="(55)"> <text>“State residential center (SRC)” means a State owned and operated facility for individuals with intellectual disabilities.</text> </paragraph> <paragraph num="(56)"> <text>“Supports” means the assistance provided to individuals or their families to enable greater participation in the community and enhanced quality of life.</text> </paragraph> <paragraph num="(57)"> <text>“Target behaviors” means those behaviors identified by the team to be changed by implementing a behavior plan.</text> </paragraph> <paragraph num="(58)"> <text>“Team” means those persons, including the individual, proponent, licensee representatives, resource coordinator, and others involved in the development of the IP.</text> </paragraph> <paragraph num="(59)"> <text>“Temporary augmentation of staff” means supplemental staff utilized on a time-limited basis to work with an individual exhibiting challenging behavior.</text> </paragraph> <paragraph num="(60)"> <text>“Treating professional” means an individual designated by the facility director who is involved in the implementation of the IP.</text> </paragraph> <paragraph num="(61)"> <text>“Verbal abuse” means disrespectful shouting, screaming, swearing, name calling, or other verbal activity directed toward an individual.</text> </paragraph> <paragraph num="(62)"> <text>“Vocational assessment” means a method of determining an individual's job and career preferences and the skills and training necessary to accomplish these preferences.</text> </paragraph> <paragraph num="(63)"> <text>“Volunteer work” means work performed by an individual without pay.</text> </paragraph> <paragraph num="(64)"> <text>“Written plan of habilitation” means, for State residential centers, a component of the IP as described in COMAR 10.22.05.02B(14) and .03C.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency action extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 25, 2013 (40:23 Md. R. 1934); March 13, 2017 (44:5 Md. R. 293)</annotation> </annotations> </chapter> <chapter num="02" heading="Administrative Requirements for Licensees"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations, (Effective Date: January 15, 2013), is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="License Required."> <paragraph num="A."> <text>In addition to any other license required by law, a person shall be licensed by the Administration before the person may provide any of the following services to an individual with a developmental disability or to an individual eligible to receive individual support services:</text> <paragraph num="(1)"> <text>Vocational and day services;</text> </paragraph> <paragraph num="(2)"> <text>Community residential services;</text> </paragraph> <paragraph num="(3)"> <text>Resource coordination;</text> </paragraph> <paragraph num="(4)"> <text>More than one family support service, as defined in Health-General Article, §7-701, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>More than one individual support service, as defined in Health-General Article, §7-706, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(6)"> <text>More than one community supported living arrangement service as defined in Health-General Article, §7-709, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver. The Director may waive the requirement for a license if a person is licensed or certified by another State agency or accredited by a national accreditation agency, such as the Council on Quality and Leadership in Supports for People with Developmental Disabilities or the Council for Accreditation for Rehabilitation Facilities (CARF), to provide services to an individual with a developmental disability or to an individual eligible for individual support services.</text> </paragraph> <paragraph num="C."> <text>After notice and an opportunity for a hearing, the Director may revoke the waiver granted under §B of this regulation if, through inspection, it is determined that a person is providing services which would not conform in substantial part to the licensing requirements of this subtitle.</text> </paragraph> <paragraph num="D."> <text>A person who provides residential services to a child with a developmental disability shall meet the requirements of COMAR 14.31.05, 14.31.06, and 14.31.07, in addition to the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for Initial License or Renewal."> <paragraph num="A."> <text>To obtain and maintain a license, an applicant shall, at a minimum:</text> <paragraph num="(1)"> <text>Except for local health departments, be properly organized as a Maryland corporation, a forensic residential center (FRC), or a State residential center (SRC), or, if operating as a foreign corporation, be properly registered to do business in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have a governing body that is legally responsible for overseeing the management and operation of all programs conducted by the licensee;</text> </paragraph> <paragraph num="(3)"> <text>Have a governing body that is legally responsible for ensuring that each aspect of the licensee's program operates in compliance with all of the requirements of this chapter and all other applicable laws and regulations; and</text> </paragraph> <paragraph num="(4)"> <text>Except for currently licensed providers, demonstrate the capability to provide or arrange for the provision of all applicable services required by this chapter by submitting, at a minimum, the following documents to the Department:</text> <paragraph num="(a)"> <text>A business plan that clearly demonstrates the ability of the applicant to provide services in accordance with this chapter;</text> </paragraph> <paragraph num="(b)"> <text>A summary of the applicant's demonstrated experience in the field of developmental disabilities;</text> </paragraph> <paragraph num="(c)"> <text>Prior licensing reports issued within the previous 10 years from any in-State or out-of-State entity associated with the applicant, including deficiency reports and compliance records; and</text> </paragraph> <paragraph num="(d)"> <text>A written quality assurance plan approved by the Administration in accordance with Regulation .14 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If currently licensed, produce, upon written request from the Administration, the document required under §A(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall file an application for a license or license renewal on a written or electronic form provided by the Administration. An existing licensee shall file an application for renewal at least 60 days before expiration of its existing license. The license does not expire until the Director takes an action under §D of this regulation and the time for seeking judicial review or any judicial stay of the final action expires.</text> </paragraph> <paragraph num="C."> <text>The administrative head of the corporation or two of its officers, local health officer, or SRC director, shall submit the application.</text> </paragraph> <paragraph num="D."> <text>When an application for initial licensure or renewal is submitted, the Director may:</text> <paragraph num="(1)"> <text>Approve the application unconditionally and issue a license;</text> </paragraph> <paragraph num="(2)"> <text>Approve the application with conditions and issue a license;</text> </paragraph> <paragraph num="(3)"> <text>Deny the application for any reason including if an applicant has had a:</text> <paragraph num="(a)"> <text>License revoked by the Department within the previous 10 years; or</text> </paragraph> <paragraph num="(b)"> <text>Corporate officer who has served as a corporate officer for a licensee that has had a license revoked by the Department within the previous 10 years; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Require additional information before a licensure decision is made.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Hearing Request.</text> <paragraph num="(1)"> <text>If the Director proposes to deny a license under this section, the Director shall notify the applicant in writing of the proposed decision and inform the applicant of the reason for the proposed denial and the right to a hearing.</text> </paragraph> <paragraph num="(2)"> <text>A request for a hearing, including a copy of the Director's action, shall be filed with the Office of Administrative Hearings with a copy to the Administration not later than 30 days after receiving notice of the Director's proposed action.</text> </paragraph> <paragraph num="(3)"> <text>A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03.</text> </paragraph> <paragraph num="(4)"> <text>The burden of proof is as set forth in COMAR 10.01.03.28.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01.</text> </paragraph> <paragraph num="(6)"> <text>The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35.</text> </paragraph> <paragraph num="(7)"> <text>A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Voluntary Surrender of License.</text> <paragraph num="(1)"> <text>If a licensee intends to voluntarily surrender its license, the licensee shall submit a closure schedule which the Director shall approve before the surrender becomes effective.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall submit a schedule for closure to the Director, in writing, at least 90 days before surrendering its license.</text> </paragraph> <paragraph num="(3)"> <text>The Director may grant the requested closure schedule as submitted, or require the licensee to continue to operate for an additional 90 days to allow the Administration time to plan for the continued provision of services to the individuals served by the licensee.</text> </paragraph> <paragraph num="(4)"> <text>The Administration shall notify appropriate individuals and proponents of the licensee's intent to surrender its license and of the Director's approved closure schedule.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The licensee may terminate services to an individual for good cause only with the written approval of the Director. The licensee shall:</text> <paragraph num="(1)"> <text>Notify the Director in writing 90 days before the date it proposes to terminate services to an individual;</text> </paragraph> <paragraph num="(2)"> <text>Notify the individual, and proponent, when appropriate, in writing, of its intent to terminate services and the individual's right to a hearing under COMAR 10.22.16, within the same time frame set forth in §G(1) of this regulation, and provide copies of that notice at that time to the appropriate regional office and members of the individual's team; and</text> </paragraph> <paragraph num="(3)"> <text>Consider the service terminated, if an individual is absent from a service for 60 consecutive days, unless otherwise determined by the Director.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Investigation by the Administration."> <paragraph num="A."> <text>This regulation sets forth the roles of the Developmental Disabilities Administration and the Office of Health Care Quality in investigation and follow-up of reportable incidents.</text> </paragraph> <paragraph num="B."> <text>Licensee to be Open for Inspection. A licensee shall be open at all reasonable times to announced and unannounced inspections by the Administration or its designee.</text> </paragraph> <paragraph num="C."> <text>Records and Reports. A licensee shall maintain records and make reports as required by the Administration. The records and reports shall be open to inspection by the Administration. A licensee shall immediately, on request of the Administration, provide copies of the records and reports, including medical records of individuals, to the Administration.</text> </paragraph> <paragraph num="D."> <text>Protocol to Determine Necessity to Investigate.</text> <paragraph num="(1)"> <text>The Administration, through its agent, the Office of Health Care Quality (OHCQ), shall investigate reportable incidents, events, or problems involving individuals in a community agency or State residential center based on the scope and severity in accordance with the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall report incidents in accordance with the requirements and timelines outlined in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text> </paragraph> <paragraph num="(3)"> <text>The necessity for investigation is determined by the following priorities:</text> <paragraph num="(a)"> <text>Priority Level 1 — Immediate Jeopardy — Initiate investigation within 2 working days of receipt;</text> </paragraph> <paragraph num="(b)"> <text>Priority Level 2 — High—Initiate investigation within 4 working days of receipt;</text> </paragraph> <paragraph num="(c)"> <text>Priority Level 3 — Other Harm — Initiate an investigation within 30 working days of receipt;</text> </paragraph> <paragraph num="(d)"> <text>Priority Level 4 — Administrative Review — Review during preparation for licensee's annual survey;</text> </paragraph> <paragraph num="(e)"> <text>Priority Level 5 — Referrals — Refer to internal OHCQ unit or appropriate agency for follow-up within 1 working day; or</text> </paragraph> <paragraph num="(f)"> <text>Priority Level 6 — Death — Upon notification, refer to the Mortality Review Unit of OHCQ within 1 working day for review and investigation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Timelines for Specific Reports and Follow-Up Protocols.</text> <paragraph num="(a)"> <text>The licensee shall submit a plan of correction (POC) within 10 working days of the receipt of deficiencies. The POC due date may be sooner than 10 working days when the nature of the deficiency warrants a more immediate response, as determined by the OHCQ and as outlined in Appendix 6 of the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text> </paragraph> <paragraph num="(b)"> <text>If the POC is determined to be acceptable, the OHCQ shall, whenever possible, within 10 working days of approving the POC, send the statement of deficiency and the POC to the:</text> <paragraph num="(i)"> <text>Licensee who is required to share this information with the individual receiving services, who is the specific subject of a deficient practice, or to the resource coordinator, a guardian, or a family member as appropriate and set forth in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations;</text> </paragraph> <paragraph num="(ii)"> <text>Complainant;</text> </paragraph> <paragraph num="(iii)"> <text>Agency's Executive Director and Board President;</text> </paragraph> <paragraph num="(iv)"> <text>DDA Regional Office;</text> </paragraph> <paragraph num="(v)"> <text>Maryland Disability Law Center when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations;</text> </paragraph> <paragraph num="(vi)"> <text>Medicaid Fraud Control Unit of the Attorney General's Office when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations; and</text> </paragraph> <paragraph num="(vii)"> <text>Any other parties determined to be appropriate by OHCQ.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the POC is determined to be unacceptable, the OHCQ shall, whenever possible, notify the agency in writing within 5 working days of receipt of the issues which require further review and consideration. The licensee shall resubmit to OHCQ a revised POC within 5 working days from notification of an unacceptable POC.</text> </paragraph> <paragraph num="(d)"> <text>OHCQ shall conduct follow-up monitoring in accordance with Developmental Disabilities Administration Policy on Reportable Incidents and Investigations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Methods of Investigation. OHCQ shall conduct investigations through:</text> <paragraph num="(1)"> <text>On-site inspections;</text> </paragraph> <paragraph num="(2)"> <text>Interviews; or</text> </paragraph> <paragraph num="(3)"> <text>Reviews of relevant records and documents.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The licensee and OHCQ may receive extensions of the time periods set forth in this regulation for good cause shown.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Compliance Monitoring."> <paragraph num="A."> <text>The Administration, through its agent, the Office of Health Care Quality (OHCQ), is responsible for monitoring and inspecting the Administration's licensees to ensure regulatory compliance.</text> </paragraph> <paragraph num="B."> <text>The Administration shall conduct an on-site pre-licensure survey.</text> </paragraph> <paragraph num="C."> <text>The Administration shall conduct announced and unannounced licensure visits at any time the Administration considers necessary, but at least annually, and provide the licensee with any notification of noncompliance.</text> </paragraph> <paragraph num="D."> <text>The Administration shall conduct announced or unannounced complaint investigation visits at any time the Administration considers necessary and provide the licensee with notification of any noncompliance.</text> </paragraph> <paragraph num="E."> <text>The licensee shall submit a plan of correction (POC) at the end of an exit conference, or within 10 working days of receipt of the findings of noncompliance. The POC due date may be sooner than 10 working days when the nature of the noncompliance warrants a more immediate response, as determined by the OHCQ. The Director of the OHCQ may grant an extension of not more than 30 days for the submission of the POC.</text> </paragraph> <paragraph num="F."> <text>If a POC is deemed unacceptable by the OHCQ, the licensee shall resubmit a revised POC within 10 working days to the OHCQ for approval.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="New Site, Site Closure, or Relocation."> <paragraph num="A."> <text>A licensee may not open, close, or relocate any site without approval of the Administration. If a licensee intends to open, close, or relocate any site, the licensee shall request approval from the Administration and submit documentation as required by the Administration at least 30 days before the date the licensee intends to make the change.</text> </paragraph> <paragraph num="B."> <text>If a licensee is required to open, close, or relocate a site due to an emergency and the notice requirements set forth in §A of this regulation cannot be met, the licensee shall notify the regional director as soon as the change occurs. The regional director shall notify the OHCQ of this change. The OHCQ shall ensure that the change meets with its approval.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Licensed Capacity."> <paragraph num="A."> <text>A license issued by the Administration shall include the number of individuals for whom the licensee is permitted to provide services.</text> </paragraph> <paragraph num="B."> <text>A licensee may exceed its licensed capacity only if the Director:</text> <paragraph num="(1)"> <text>Requests in writing that the licensee exceed its licensed capacity; or</text> </paragraph> <paragraph num="(2)"> <text>Approves a written request from a licensee to exceed its licensed capacity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall include in its written request to exceed its licensed capacity:</text> <paragraph num="(1)"> <text>The circumstances or reasons for the request;</text> </paragraph> <paragraph num="(2)"> <text>The identity of all individuals involved; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation that all individuals involved have been informed of the plan to exceed licensed capacity.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Permission to exceed licensed capacity shall be:</text> <paragraph num="(1)"> <text>Granted for not more than 60 days; and</text> </paragraph> <paragraph num="(2)"> <text>Extended for not more than an additional 60 days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Individual Family Care (IFC)."> <paragraph num="A."> <text>On the effective date of this chapter, a community residential licensee providing IFC services may not contract with an IFC care provider who has a contract with another community residential licensee who provides IFC services.</text> </paragraph> <paragraph num="B."> <text>Notwithstanding §A of this regulation, an individual who is receiving services in an IFC home before the effective date of these regulations may continue to receive services in that home.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Governing Body."> <paragraph num="A."> <text>A local health department's governing body is the governing body of the respective county as set forth in Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Except for local health departments, forensic residential centers (FRCs), and State residential centers, the governing body of all licensees shall include, at a minimum, at least one individual with a developmental disability, one family member of an individual with a developmental disability, and an individual with experience in the field of developmental disabilities.</text> </paragraph> <paragraph num="C."> <text>Except for local health departments, forensic residential centers (FRCs), and State residential centers, the governing body of all licensees shall adopt written bylaws which require the governing body to be legally responsible for:</text> <paragraph num="(1)"> <text>Overseeing the management and operation of the licensee;</text> </paragraph> <paragraph num="(2)"> <text>Ensuring that the licensee operates in compliance with all of the requirements of this chapter and all other applicable laws and regulations;</text> </paragraph> <paragraph num="(3)"> <text>Approving a licensee's mission statement, long-range goals, policies, procedures, and budget;</text> </paragraph> <paragraph num="(4)"> <text>Defining and prohibiting those circumstances which would create a financial or personal conflict of interest for members of the governing body, staff, care providers, volunteers, and members of the standing committee;</text> </paragraph> <paragraph num="(5)"> <text>Ensuring that the licensee responds to all POCs in a timely manner;</text> </paragraph> <paragraph num="(6)"> <text>Approving a licensee's program service plan and ensuring that its services are provided in accordance with the plan;</text> </paragraph> <paragraph num="(7)"> <text>Ensuring that at least 75 percent of the governing body of a licensee shall be residents of the State or reside within a 100 mile radius of the administrative offices of the licensee, which shall be located in the State unless the licensee:</text> <paragraph num="(a)"> <text>Has established an Administration approved community-based advisory board or committee; and</text> </paragraph> <paragraph num="(b)"> <text>Receives an Administration approved waiver;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Ensuring that no employee of a licensee or immediate family member of an employee of a licensee may serve as a voting member of the governing body of the licensee unless:</text> <paragraph num="(a)"> <text>The employee receives services from the licensee; or</text> </paragraph> <paragraph num="(b)"> <text>The Administration approves the composition of the governing body through an innovative program services plan in accordance with Regulation .09 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Ensuring that by January 1, 2008, members of the governing body and employees of the licensee may not own property that is leased back to the licensee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Program Service Plan (PSP)."> <paragraph num="A."> <text>To receive a license from the Administration under this chapter, the applicant shall develop and submit for approval, as part of its application, a PSP for each service it provides.</text> </paragraph> <paragraph num="B."> <text>If the licensee makes a change in its PSP, the licensee shall submit its revised PSP for the Administration's approval before the implementation of the changes.</text> </paragraph> <paragraph num="C."> <text>The administrative head of the licensee shall assure that the PSP is reviewed by its governing body and updated at least every 3 years.</text> </paragraph> <paragraph num="D."> <text>The licensee shall comply with all provisions of its approved PSP.</text> </paragraph> <paragraph num="E."> <text>Contents. The licensee shall ensure the PSP includes the following components:</text> <paragraph num="(1)"> <text>Rationale, which includes a discussion of the applicant's philosophy for the provision of services;</text> </paragraph> <paragraph num="(2)"> <text>Scope, which includes a discussion of the specific services to be provided;</text> </paragraph> <paragraph num="(3)"> <text>Staffing and training, which includes a description of the staff or care providers necessary to provide the services outlined in §E(2) of this regulation and a description of any additional training required by its staff other than provided in Regulation .11 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Setting and location, which includes a description of where the services are to be provided and the number of individuals expected to be served.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Innovative Program Service Plan Variance.</text> <paragraph num="(1)"> <text>If an applicant or licensee wants to provide services or supports through an alternative model not currently regulated by this subtitle, the applicant or licensee may submit a PSP and request approval from the Administration to provide services or supports through this alternative model.</text> </paragraph> <paragraph num="(2)"> <text>The Administration shall consider whether the proposed model meets the overall goals of the Administration and reflects the values and outcomes delineated in COMAR 10.22.04.</text> </paragraph> <paragraph num="(3)"> <text>The Administration may approve the proposed model, as proposed, or with conditions, including which regulatory requirements of this subtitle would apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Policies and Procedures."> <paragraph num="A."> <text>A licensee shall develop and adopt written policies and procedures for ensuring:</text> <paragraph num="(1)"> <text>That each individual's health and safety needs, as identified in the individual plan (IP), are being met;</text> </paragraph> <paragraph num="(2)"> <text>Fundamental rights in accordance with Health-General Article, §7-1002, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>That services are provided in a manner which promotes individual choice and the exercise of individual rights;</text> </paragraph> <paragraph num="(4)"> <text>Confidentiality for each individual in accordance with Health-General Article, §7-1010, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>The implementation of a grievance process with safeguards which protect against retaliatory actions for the filing of any grievance;</text> </paragraph> <paragraph num="(6)"> <text>That services are provided without discrimination;</text> </paragraph> <paragraph num="(7)"> <text>That all incidents, including those involving life-threatening conditions, are reported and investigated in accordance with the Administration's procedures on reportable incidents;</text> </paragraph> <paragraph num="(8)"> <text>That medications are administered in accordance with the practices established by the Administration's curriculum on medication training;</text> </paragraph> <paragraph num="(9)"> <text>Compliance with COMAR 10.27.11;</text> </paragraph> <paragraph num="(10)"> <text>That an individual whose behavior requires intervention receives the safeguards required by this regulation;</text> </paragraph> <paragraph num="(11)"> <text>That in order for an individual to be required to pay for property damage caused by the individual's actions, the individual's IP shall show evidence that the:</text> <paragraph num="(a)"> <text>Individual has a history of destructive behavior that has been documented in the behavior plan (BP),</text> </paragraph> <paragraph num="(b)"> <text>Individual has a BP that addresses the destructive behavior,</text> </paragraph> <paragraph num="(c)"> <text>Individual has the ability to pay for damages,</text> </paragraph> <paragraph num="(d)"> <text>Licensee's standing committee, as described in Regulation .08 of this chapter, has reviewed and approved the damage payment, and</text> </paragraph> <paragraph num="(e)"> <text>Licensee has reported this approval to the regional director;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Compliance with Health-General Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(13)"> <text>That there is no financial or personal conflict of interest for members of the governing body, staff, care providers, volunteers, and standing committee members;</text> </paragraph> <paragraph num="(14)"> <text>That the fiscal affairs of the licensee are conducted in accordance with generally accepted accounting practices;</text> </paragraph> <paragraph num="(15)"> <text>That there is adequate protection for the finances and property of each individual, including:</text> <paragraph num="(a)"> <text>A system to ensure that each individual's funds are used in an appropriate manner consistent with the individual's needs and preferences,</text> </paragraph> <paragraph num="(b)"> <text>A system to keep personal funds separate from the funds of the licensee and to ensure that funds are transferred to the individual in a timely manner when services are no longer being provided,</text> </paragraph> <paragraph num="(c)"> <text>Timely access for the individual to the funds,</text> </paragraph> <paragraph num="(d)"> <text>An accounting of the individual's funds, on request, and</text> </paragraph> <paragraph num="(e)"> <text>The accrual of any interest into the individual's account from an interest-bearing account;</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>That State and federally required safety precautions, infection control, and standard precautions are implemented;</text> </paragraph> <paragraph num="(17)"> <text>That an effective disaster and emergency evacuation plan, with sufficient evacuation drills is in place;</text> </paragraph> <paragraph num="(18)"> <text>That an individual may not perform the duties of a paid staff person; and</text> </paragraph> <paragraph num="(19)"> <text>That an individual only perform those duties and tasks that are shared by the household or included as an activity documented in the individual's IP or remunerated as part of a training program as required by federal or State law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed community residential service provider offering services in alternative living units or group homes shall develop an emergency plan for all types of emergencies and disasters that shall include:</text> <paragraph num="(1)"> <text>Procedures that will be followed before, during, and after an emergency to address the following:</text> <paragraph num="(a)"> <text>The evacuation, transportation, or 72 hour shelter-in-place of individuals and staff served;</text> </paragraph> <paragraph num="(b)"> <text>Holding an annual practice drill coordinated with local emergency planners for sheltering in place or evacuating;</text> </paragraph> <paragraph num="(c)"> <text>Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions;</text> </paragraph> <paragraph num="(d)"> <text>Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation;</text> </paragraph> <paragraph num="(e)"> <text>The role of the resident, family member, or legal representative in the event of evacuation;</text> </paragraph> <paragraph num="(f)"> <text>Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and</text> </paragraph> <paragraph num="(g)"> <text>Establishing a communication protocol among all appropriate parties that includes redundant communication means;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notification to families, staff, and the respective DDA regional office (licensing authority) regarding the action that will be taken concerning the safety and well-being of the individuals served;</text> </paragraph> <paragraph num="(3)"> <text>The staff coverage, organization, and assignment of responsibilities that includes:</text> <paragraph num="(a)"> <text>Planning staff coverage needs for ongoing shelter in place or evacuations;</text> </paragraph> <paragraph num="(b)"> <text>Identifying staff members available to report for work or remain during extended periods; and</text> </paragraph> <paragraph num="(c)"> <text>Establishing staff notification and recall contingency plans and procedures;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities;</text> </paragraph> <paragraph num="(5)"> <text>Procedures to:</text> <paragraph num="(a)"> <text>Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions;</text> </paragraph> <paragraph num="(b)"> <text>Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning; and</text> </paragraph> <paragraph num="(7)"> <text>An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensee shall ensure that all staff, care providers, consultants, and volunteers are aware of the policies required by this chapter and that all staff, care providers, consultants, and volunteers implement each policy as adopted.</text> </paragraph> <paragraph num="D."> <text>The licensee shall ensure that it provides sufficient information about its grievance process to each individual it serves and, when appropriate, to the individual's proponent, to enable the individual or proponent to use the process effectively.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Staffing Requirements."> <paragraph num="A."> <text>Following an analysis of the number of individuals the licensee intends to serve and the needs of each of these individuals being served, the licensee shall develop and implement a staffing plan that adequately addresses the health and safety needs of each individual and provides each individual with the services identified in the IP. The staffing plan may include any person who meets the training requirements of this regulation and who does not have a criminal history as set forth in §B of this regulation. A staff person who meets the above criteria may assume all responsibilities previously assigned to a qualified developmental disabilities professional.</text> </paragraph> <paragraph num="B."> <text>A licensee may not employ or contract with any person who has a criminal history which would indicate behavior potentially harmful to individuals, documented through either a criminal history records check or a criminal background check, pursuant to Health-General Article, §19-1902 et seq., Annotated Code of Maryland, and COMAR 12.15.03.</text> </paragraph> <paragraph num="C."> <text>The licensee shall develop and implement staff and care provider training and ensure through appropriate documentation that, before being assigned independent duties:</text> <paragraph num="(1)"> <text>All staff and care providers receive adequate training to perform their assigned duties;</text> </paragraph> <paragraph num="(2)"> <text>All staff and care providers successfully complete the Administration's approved training to meet the specific needs of the individuals they serve and to carry out their assigned duties, such as training in:</text> <paragraph num="(a)"> <text>Seizure disorders,</text> </paragraph> <paragraph num="(b)"> <text>Principles of behavior change,</text> </paragraph> <paragraph num="(c)"> <text>Management of disruptive behaviors,</text> </paragraph> <paragraph num="(d)"> <text>Medication administration, and</text> </paragraph> <paragraph num="(e)"> <text>The aging process and the special needs of the elderly; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All staff and care providers receive training in blood-borne pathogens in accordance with OSHA guidelines found in 29 CFR §1910.1030, which is incorporated by reference.</text> </paragraph> </paragraph> <paragraph num="D."> <text>All staff and care providers shall receive Administration-approved training within 3 months of hire in the following:</text> <paragraph num="(1)"> <text>Community integration and inclusion,</text> </paragraph> <paragraph num="(2)"> <text>Individual-directed, outcome-oriented planning for individuals,</text> </paragraph> <paragraph num="(3)"> <text>General characteristics and needs of individuals served,</text> </paragraph> <paragraph num="(4)"> <text>First aid and cardiopulmonary resuscitation (CPR), based on the guidelines of the American Red Cross or another nationally recognized organization,</text> </paragraph> <paragraph num="(5)"> <text>Fundamental rights of individuals with developmental disabilities,</text> </paragraph> <paragraph num="(6)"> <text>Communicable diseases,</text> </paragraph> <paragraph num="(7)"> <text>Supporting individuals and families in making choices, and</text> </paragraph> <paragraph num="(8)"> <text>Communication skills.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee shall develop and adopt:</text> <paragraph num="(1)"> <text>Written job descriptions that include the nature and extent of training and experience required for each position; and</text> </paragraph> <paragraph num="(2)"> <text>A policy to prevent employment discrimination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Health and Safety Requirements."> <paragraph num="A."> <text>To obtain and maintain licensure, a licensee shall ensure that any licensed home or site in which the licensee provides services to individuals:</text> <paragraph num="(1)"> <text>Meets local zoning requirements, except as otherwise set forth in Health-General Article, §7-603, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Meets local and State building requirements;</text> </paragraph> <paragraph num="(3)"> <text>Meets applicable life safety requirements;</text> </paragraph> <paragraph num="(4)"> <text>Is free from safety and health hazards; and</text> </paragraph> <paragraph num="(5)"> <text>Is in good repair.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that any licensed home or site in which the licensee provides services is free from fire hazards and has the following minimum fire safety protections:</text> <paragraph num="(1)"> <text>Adequate smoke detectors;</text> </paragraph> <paragraph num="(2)"> <text>Working and updated fire extinguishers; and</text> </paragraph> <paragraph num="(3)"> <text>A written fire evacuation plan, as required by Regulation .10A(17) of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall ensure that any licensed home or site in which the licensee provides services to individuals maintains its water temperature at a maximum of 110ºF, unless:</text> <paragraph num="(1)"> <text>Each individual living in the home or receiving services at the site is capable of regulating water temperature safely; and</text> </paragraph> <paragraph num="(2)"> <text>There is documentation of the capability required in §C(1) of this regulation in each individual's IP.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In order to ensure the health and safety of individuals who require staff assistance in the administration of medication, the licensee shall:</text> <paragraph num="(1)"> <text>Require that all medication be administered in accordance with the Administration's curriculum on medication training;</text> </paragraph> <paragraph num="(2)"> <text>Provide oral, solid medications in a unit dose package unless an individual's IP indicates that this is not required;</text> </paragraph> <paragraph num="(3)"> <text>Provide medication for an individual who is absent from a program in a separate, pharmaceutically prepared package that is easily identified by the individual administering the medication; and</text> </paragraph> <paragraph num="(4)"> <text>Request, from the pharmacy, computer-generated medication administration records, treatment administration records, and physician medication order forms.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Records."> <paragraph num="A."> <text>A licensee shall maintain records for each individual at the site where the individual is being served.</text> </paragraph> <paragraph num="B."> <text>The records shall include at a minimum:</text> <paragraph num="(1)"> <text>The identifying information which appears on the individual's application for services from the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Sufficient information that enables the licensee to provide services in a manner which ensures the individual's health and safety, including:</text> <paragraph num="(a)"> <text>An emergency contact person for the individual,</text> </paragraph> <paragraph num="(b)"> <text>The names of the individual's next of kin,</text> </paragraph> <paragraph num="(c)"> <text>The individual's physician,</text> </paragraph> <paragraph num="(d)"> <text>The individual's current diagnosis,</text> </paragraph> <paragraph num="(e)"> <text>Documented allergies of the individual, and</text> </paragraph> <paragraph num="(f)"> <text>A listing of the medications the individual receives;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The IP as defined in COMAR 10.22.05;</text> </paragraph> <paragraph num="(4)"> <text>Documentation demonstrating implementation of the IP; and</text> </paragraph> <paragraph num="(5)"> <text>Any other information the Administration may require.</text> </paragraph> </paragraph> <paragraph num="C."> <text>On notification of a medical emergency, the licensee shall ensure that the individual's medical information is available and readily accessible to emergency personnel.</text> </paragraph> <paragraph num="D."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Maintain an individual's records for a minimum of 6 years, regardless of whether the individual is no longer being served or dies;</text> </paragraph> <paragraph num="(2)"> <text>Maintain documents relevant to the services the individual is currently receiving, as long as the individual is being served; and</text> </paragraph> <paragraph num="(3)"> <text>Organize an individual's record in a manner that facilitates easy access to needed information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Electronic Records.</text> <paragraph num="(1)"> <text>The licensee is encouraged to use electronic records whenever possible.</text> </paragraph> <paragraph num="(2)"> <text>Electronic records shall:</text> <paragraph num="(a)"> <text>Meet requirements in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Comply with the HIPAA privacy and security rules pertaining to personal health information (PHI); and</text> </paragraph> <paragraph num="(c)"> <text>Be properly backed up and stored at an off-site location.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Assurance."> <paragraph num="A."> <text>The licensee shall submit a quality assurance plan and any subsequent substantive changes to the plan to the Administration for approval.</text> </paragraph> <paragraph num="B."> <text>The licensee shall develop and implement a system of internal quality assurance which at a minimum:</text> <paragraph num="(1)"> <text>Is focused on the individual's choices, preferences, and satisfaction, and includes personal contact with the individuals being served;</text> </paragraph> <paragraph num="(2)"> <text>Has outcomes and results that are measurable and may be incorporated into future IPs for the individuals being served;</text> </paragraph> <paragraph num="(3)"> <text>Has outcomes and results that are measurable and may be incorporated into systemic changes in a licensee's operation;</text> </paragraph> <paragraph num="(4)"> <text>Collects and evaluates data and analyzes trends identified through quality assurance activities including:</text> <paragraph num="(a)"> <text>The name of the individual with a behavior plan,</text> </paragraph> <paragraph num="(b)"> <text>The medication or other restrictive technique used,</text> </paragraph> <paragraph num="(c)"> <text>The date and time the restrictive technique was used,</text> </paragraph> <paragraph num="(d)"> <text>Whether the medication or other restrictive technique was used as an emergency or as part of a behavior plan, and</text> </paragraph> <paragraph num="(e)"> <text>Whether the medication or other restrictive technique used is meeting the goals and objectives established in the behavior plan;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Provides for prompt and appropriate response when an individual's health or safety is at risk; and</text> </paragraph> <paragraph num="(6)"> <text>Includes proactive strategies to improve the quality of services, including health and safety.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Establish goals and standards to measure the quality of services being delivered and define how the standards are measured;</text> </paragraph> <paragraph num="(2)"> <text>Maintain records to demonstrate the effectiveness of its quality assurance activities;</text> </paragraph> <paragraph num="(3)"> <text>Implement changes based on the results of the evaluated data; and</text> </paragraph> <paragraph num="(4)"> <text>Be held accountable by the Administration for accomplishing the goals and standards that are established as part of the licensee's system of quality assurance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Administration may request documentation from a licensee to verify that the licensee is accomplishing the goals and standards set forth in the licensee's quality assurance plan.</text> </paragraph> <paragraph num="E."> <text>Standing Committees.</text> <paragraph num="(1)"> <text>The licensee shall establish a committee or committees to perform the following functions:</text> <paragraph num="(a)"> <text>Perform the quality assurance functions set forth in this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Review the licensee's protocol for identifying, reporting, documenting, investigating, and reviewing of incidents to ensure compliance with Administration procedures;</text> </paragraph> <paragraph num="(c)"> <text>Monitor whether the licensee's protocol identified in §E(2) of this regulation is being properly implemented by reviewing all incidents in an effort to identify deficient practices and recommend necessary corrective action;</text> </paragraph> <paragraph num="(d)"> <text>Approve all behavior plans which use restrictive techniques to ensure that the behavior plan complies with the requirements of COMAR 10.22.04.03A and 10.22.10;</text> </paragraph> <paragraph num="(e)"> <text>Review, approve, and establish the time frame for the restriction of a right if it is not related to a challenging behavior, in accordance with COMAR 10.22.04.03A; and</text> </paragraph> <paragraph num="(f)"> <text>Review the licensee's policies and procedures, and implementation of them, to ensure that they adequately protect the legal and human rights of each individual served by the licensee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The committee or committees may be organized to perform the functions set forth in §A of this regulation for one or more licensees.</text> </paragraph> <paragraph num="(3)"> <text>The committee or committees shall include an equal number of licensee staff, and individuals, proponents, or members of the community who are not employed by the licensee. For a committee member who is remunerated only to serve as a member of the committee, that member is not counted as staff or as a member of the community.</text> </paragraph> <paragraph num="(4)"> <text>The committee or committees may consult with a licensed health professional such as a psychologist, physician, physician's assistant, nurse practitioner, or board-certified clinical pharmacist, as needed.</text> </paragraph> <paragraph num="(5)"> <text>A committee member may not participate in the decision making process of any:</text> <paragraph num="(a)"> <text>Incident in which the committee member was involved; or</text> </paragraph> <paragraph num="(b)"> <text>Behavior plan the committee member has developed.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The committee or committees shall meet as needed to perform the functions identified in §E(1) of this regulation, with, at least, a majority of members present.</text> </paragraph> <paragraph num="(7)"> <text>The committee or committees shall ensure confidentiality for the individual in accordance with Health-General Article, §7-1010, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-904 and 7-909, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended and recodified to be Regulation .01-1 and new Regulation .01 adopted effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 22, 2013 (40:14 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, D amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, C amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, C amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 17, 2007 (34:25 Md. R. 2210)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D amended effective March 3, 2014 (41:4 Md. R. 300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13E adopted effective March 3, 2014 (41:4 Md. R. 300)</annotation> </annotations> </chapter> <chapter num="03" heading="Procedures for License Denials and Disciplinary Sanctions"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter describes the procedures for a license denial and disciplinary action against a licensee.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In addition to the definitions set forth in COMAR 10.22.01, in this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Isolated scope” means that the identified deficiency has occurred only once, in only one location, or for only one individual.</text> </paragraph> <paragraph num="(2)"> <text>“Low scope” means that the deficiency has occurred only occasionally, in sporadic locations, or for only a few individuals.</text> </paragraph> <paragraph num="(3)"> <text>“Minor impact” means there has been little or no negative effect on an individual's health, safety, rights, or quality of life.</text> </paragraph> <paragraph num="(4)"> <text>“Moderate impact” means an individual has experienced a significant health or safety consequence, a violation of rights, or infringement on quality of life, or that these consequences may likely occur in the near future.</text> </paragraph> <paragraph num="(5)"> <text>“Repeated scope” means that the deficiency has occurred on a regular basis, in several locations, or for several individuals.</text> </paragraph> <paragraph num="(6)"> <text>“Severe impact” means an individual has experienced a deterioration in the individual's medical or psychological condition, has been exposed to a serious safety risk, has experienced frequent rights violations, or infringements on the individual's quality of life, or that these consequences may likely occur in the near future.</text> </paragraph> <paragraph num="(7)"> <text>“Widespread scope” means that the deficiency has occurred consistently, in most locations, or for a majority of people.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Failure to Submit Acceptable Plan of Correction."> <text>A licensee, including a licensee with deficiencies having only a minor impact, is subject to any intermediate sanction set forth in Regulation .04 of this chapter for failure to comply with COMAR 10.22.02.04E and F.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Intermediate Sanctions."> <paragraph num="A."> <text>After notice and an opportunity for a hearing, the Director may impose any intermediate sanctions listed in §B of this regulation if:</text> <paragraph num="(1)"> <text>Deficiencies have a moderate impact and the scope of the deficiencies occurs on an isolated, low, repeated, or widespread basis; or</text> </paragraph> <paragraph num="(2)"> <text>Deficiencies have a severe impact and the scope of the deficiencies occurs on an isolated, low, repeated, or widespread basis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For purposes of §A of this regulation, intermediate sanctions include:</text> <paragraph num="(1)"> <text>A directed plan of correction, when the licensee is directed to take a specific action by a certain date;</text> </paragraph> <paragraph num="(2)"> <text>A mandatory staffing pattern, when the Administration defines for the licensee the level of individual supervision required at a particular site or program;</text> </paragraph> <paragraph num="(3)"> <text>Mandatory training, when the Administration identifies deficient areas in which training is needed;</text> </paragraph> <paragraph num="(4)"> <text>Individual relocation, when the Administration reserves the right to relocate an individual to another licensee in order to protect the health or safety of the individual;</text> </paragraph> <paragraph num="(5)"> <text>Expansion ban, when the Administration retains the authority to prohibit the licensee from obtaining additional sites, admitting individuals, or providing additional services at the site;</text> </paragraph> <paragraph num="(6)"> <text>Imposition of an intensive monitoring protocol by the Administration; or</text> </paragraph> <paragraph num="(7)"> <text>Imposition of a temporary site monitor, when the Administration maintains an on-going physical presence for the purpose of providing assistance and evaluating the extent of the licensee's corrective actions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Summary Suspension."> <paragraph num="A."> <text>Pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a pre-deprivation hearing, the Director may summarily order the suspension of a license if the Administration finds that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="B."> <text>The Director shall notify the licensee in writing of the suspension, the findings, and the reasons that support the findings, and, when appropriate, the opportunity for a pre-deprivation hearing. The notice shall include:</text> <paragraph num="(1)"> <text>The proposed order for summary suspension which includes:</text> <paragraph num="(a)"> <text>The statutory and regulatory authority upon which the order is based,</text> </paragraph> <paragraph num="(b)"> <text>The facts supporting the alleged violations of law,</text> </paragraph> <paragraph num="(c)"> <text>The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals, and</text> </paragraph> <paragraph num="(d)"> <text>The licensee's right to appeal the summary suspension, if executed by the Director; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A show cause notice providing an opportunity for the licensee to show cause as to why the order should not be issued if the public health, safety, and welfare permits.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Director may suspend a license without prior notice and the opportunity to be heard if:</text> <paragraph num="(1)"> <text>The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension;</text> </paragraph> <paragraph num="(2)"> <text>Notice of an opportunity to be heard before the action is not feasible; and</text> </paragraph> <paragraph num="(3)"> <text>The Administration provides the licensee with a post-deprivation hearing opportunity within 15 working days of the suspension.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Administration shall:</text> <paragraph num="(1)"> <text>Notify the individuals being served by the licensee and, if appropriate, their families or proponents, regarding the summary suspension; and</text> </paragraph> <paragraph num="(2)"> <text>Assist the individuals in finding alternative services if the license is summarily suspended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Denial, Probation, Suspension, or Revocation."> <paragraph num="A."> <text>In addition to any intermediate sanctions, the Director may deny a license or take disciplinary action against a licensee if:</text> <paragraph num="(1)"> <text>An applicant fails to meet the regulations governing the services for which it is applying for a license;</text> </paragraph> <paragraph num="(2)"> <text>A licensee fails to comply with the regulations governing its services; or</text> </paragraph> <paragraph num="(3)"> <text>A licensee fails to cooperate with the Department during an investigation or licensing survey.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Director proposes to deny approval to an applicant or take disciplinary action against a licensee, the Director shall give written notice to the governing body, the executive director, the regional director, the Health Care Financing Administration, and, as appropriate, other interested parties.</text> </paragraph> <paragraph num="C."> <text>In the written notice under §B of this regulation, the Director shall include:</text> <paragraph num="(1)"> <text>The statutory and regulatory authority upon which the proposed action is based;</text> </paragraph> <paragraph num="(2)"> <text>The facts supporting the alleged violations of law; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant's or licensee's right to a hearing under Regulation .07 of this chapter before final action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Hearings."> <paragraph num="A."> <text>If the Secretary proposes to deny a license or take disciplinary action against a licensee, the Director shall give the licensee written notice according to Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Within 10 working days of receipt of the notice, the governing body or health officer may file a written request for a hearing with the Office of Administrative Hearings with copies of the request to the:</text> <paragraph num="(1)"> <text>Director;</text> </paragraph> <paragraph num="(2)"> <text>Regional director; and</text> </paragraph> <paragraph num="(3)"> <text>Administrative prosecutor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the governing body or the health officer does not file a request for a hearing within 10 working days of receipt of the notification, the licensee waives its right to request a hearing, and the Director may implement the proposed action.</text> </paragraph> <paragraph num="D."> <text>If a timely request for a hearing has been received, the Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Notify the Director, the governing body or health officer, the regional director, and administrative prosecutor of the date, time, and location of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director.</text> </paragraph> </paragraph> <paragraph num="E."> <text>After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice to the:</text> <paragraph num="(1)"> <text>Governing body or the health officer;</text> </paragraph> <paragraph num="(2)"> <text>Regional director;</text> </paragraph> <paragraph num="(3)"> <text>Medical Care Programs;</text> </paragraph> <paragraph num="(4)"> <text>Individual and, if appropriate, their family or proponents; and</text> </paragraph> <paragraph num="(5)"> <text>Health Care Financing Administration.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A licensee may appeal a final decision from a contested case by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>In addition to disposing of a case by a hearing, the Director may dispose of a contested case by:</text> <paragraph num="(1)"> <text>Stipulation;</text> </paragraph> <paragraph num="(2)"> <text>Settlement;</text> </paragraph> <paragraph num="(3)"> <text>Consent order;</text> </paragraph> <paragraph num="(4)"> <text>Default;</text> </paragraph> <paragraph num="(5)"> <text>Withdrawal;</text> </paragraph> <paragraph num="(6)"> <text>Summary disposition; or</text> </paragraph> <paragraph num="(7)"> <text>Dismissal.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If disciplinary action is taken against a licensee, the Director shall notify the appropriate parties which include, but are not limited to the:</text> <paragraph num="(1)"> <text>Health Care Financing Administration;</text> </paragraph> <paragraph num="(2)"> <text>Medical Care Programs;</text> </paragraph> <paragraph num="(3)"> <text>Licensing and Certification Administration;</text> </paragraph> <paragraph num="(4)"> <text>MDH Corporate Compliance Office; and</text> </paragraph> <paragraph num="(5)"> <text>Maryland Disability Law Center.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .27 amended effective July 25, 1980 (7:15 Md. R. 1425)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .27, Group Homes for the Mentally Retarded, repealed effective September 21, 1986 (13:19 Md. R. 2121)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07, Community Residential Services for Mentally Retarded and Nonretarded Developmentally Disabled Individuals, adopted effective September 12, 1986 (13:19 Md. R. 2121)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 26, 1988 (15:26 Md. R. 2983)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Community Residential Services for Individuals with Developmental Disability, repealed and new chapter, General Provisions for Sanctions and Appeals, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> </annotations> </chapter> <chapter num="04" heading="Values, Outcomes, and Fundamental Rights"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter identifies the values and outcomes that enhance the quality of life for individuals who are receiving services in the SRCs, FRCs, and the community. It is understood, however, that all of the referenced outcomes might not be evident in the lives of all individuals at all times. The licensee shall make every effort to facilitate the achievement of these outcomes. It is understood, however, that the achievement of these outcomes may be influenced by the needs, preferences, and desires of an individual, health and safety considerations, or fiscal limitations.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Values to be Considered in the Development of the IP."> <text>The following values shall be considered in the development of the IP:</text> <paragraph num="A."> <text>Personal well-being, which includes:</text> <paragraph num="(1)"> <text>Receiving health care services that respond to the individual's needs and are consistent with those of the general population;</text> </paragraph> <paragraph num="(2)"> <text>Living and working in places that are safe;</text> </paragraph> <paragraph num="(3)"> <text>Having access to the places in which the individual lives, works, and receives services;</text> </paragraph> <paragraph num="(4)"> <text>Having continuity and security;</text> </paragraph> <paragraph num="(5)"> <text>Having one's basic needs met; and</text> </paragraph> <paragraph num="(6)"> <text>Having the time, space, and opportunity for privacy;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individual rights, which include:</text> <paragraph num="(1)"> <text>Having the same rights and protections as all other citizens under the laws and Constitution of Maryland and the United States;</text> </paragraph> <paragraph num="(2)"> <text>Having religious and cultural beliefs respected;</text> </paragraph> <paragraph num="(3)"> <text>Being free from abuse, neglect, and mistreatment;</text> </paragraph> <paragraph num="(4)"> <text>Having personal information kept in confidence;</text> </paragraph> <paragraph num="(5)"> <text>Living, working, and receiving services in a manner that is not unnecessarily restrictive;</text> </paragraph> <paragraph num="(6)"> <text>Having one's money and belongings secured; and</text> </paragraph> <paragraph num="(7)"> <text>Having access to one's money and belongings;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Choice and control, which includes:</text> <paragraph num="(1)"> <text>Being given the opportunity to express choices and opinions;</text> </paragraph> <paragraph num="(2)"> <text>Having choices about the following:</text> <paragraph num="(a)"> <text>Where to live and with whom,</text> </paragraph> <paragraph num="(b)"> <text>The appearance of one's home,</text> </paragraph> <paragraph num="(c)"> <text>The services one receives and from whom,</text> </paragraph> <paragraph num="(d)"> <text>How one spends one's time and with whom,</text> </paragraph> <paragraph num="(e)"> <text>How menus, activities, schedules, and routines are structured,</text> </paragraph> <paragraph num="(f)"> <text>Who advocates for the individual; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Having one's choices and opinions respected and addressed;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Respect and dignity, which includes:</text> <paragraph num="(1)"> <text>Being treated with courtesy and respect;</text> </paragraph> <paragraph num="(2)"> <text>Being treated with warmth and caring;</text> </paragraph> <paragraph num="(3)"> <text>Receiving positive recognition;</text> </paragraph> <paragraph num="(4)"> <text>Being spoken to and treated in an age-appropriate manner; and</text> </paragraph> <paragraph num="(5)"> <text>Living and working in places that reflect things that are valued;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Personal growth and independence by:</text> <paragraph num="(1)"> <text>Having the opportunity to develop personal goals and the opportunity to work toward achieving those goals;</text> </paragraph> <paragraph num="(2)"> <text>Receiving the supports to succeed where one chooses to live and work;</text> </paragraph> <paragraph num="(3)"> <text>Receiving the education, habilitation, and the opportunities for increased independence;</text> </paragraph> <paragraph num="(4)"> <text>Having access to technology to assist in living and learning;</text> </paragraph> <paragraph num="(5)"> <text>Having the opportunity to manage one's own affairs, including financial affairs as much as possible; and</text> </paragraph> <paragraph num="(6)"> <text>Having the opportunity to participate in individual activities;</text> </paragraph> </paragraph> <paragraph num="F."> <text>The opportunity for relationships by:</text> <paragraph num="(1)"> <text>Having the opportunity to develop and maintain meaningful ties to other people;</text> </paragraph> <paragraph num="(2)"> <text>Having relationships encouraged and supported;</text> </paragraph> <paragraph num="(3)"> <text>Having the opportunity to be connected to family and friends; and</text> </paragraph> <paragraph num="(4)"> <text>Having the opportunity for intimacy; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Community membership and social inclusion by:</text> <paragraph num="(1)"> <text>Having the opportunity to be involved in and contribute to the community;</text> </paragraph> <paragraph num="(2)"> <text>Having the opportunity to participate in community activities of one's choice;</text> </paragraph> <paragraph num="(3)"> <text>Having the opportunity to use the same resources as other people; and</text> </paragraph> <paragraph num="(4)"> <text>Having regular access to recreation and leisure time activities with others.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fundamental Rights."> <paragraph num="A."> <text>Each individual is entitled to the basic rights set forth in Health-General Article, §§7-1002 — 7-1004, Annotated Code of Maryland, unless the individual's team decides it is necessary to restrict a right. If the restriction is due to a challenging behavior, the licensee shall follow the procedures outlined in COMAR 10.22.10. If it is necessary to restrict a right not related to a challenging behavior, the standing committee shall review, approve, and establish the time frame for the restriction. The licensee shall:</text> <paragraph num="(1)"> <text>Document in the IP the:</text> <paragraph num="(a)"> <text>Right being restricted,</text> </paragraph> <paragraph num="(b)"> <text>Reason for the restriction,</text> </paragraph> <paragraph num="(c)"> <text>Conditions under which the restriction is employed,</text> </paragraph> <paragraph num="(d)"> <text>Efforts to restore the right to the individual, and</text> </paragraph> <paragraph num="(e)"> <text>Conditions under which the right would be restored;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comply with COMAR 10.22.10.06D and E; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the restriction:</text> <paragraph num="(a)"> <text>Represents the least restrictive, effective alternative, and</text> </paragraph> <paragraph num="(b)"> <text>Is only implemented after other methods have been systematically tried and objectively determined to be ineffective.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Each licensee shall provide for the preservation of each individual's fundamental rights in accordance with Health-General Article, §7-1003, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Each licensee shall ensure that the individual and the individual's family is made aware of and given a copy of these rights, and that they are posted in accordance with Health-General Article, §7-1002, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> </annotations> </chapter> <chapter num="05" heading="The Individual Plan"> <regulation prefix="Regulation" num=".01" heading="Rationale."> <text>Through an individual directed approach, each individual, with assistance from the individual's team, is the designer of the services and supports reflected in the individual plan (IP). The provision of these services and supports may be influenced by health and safety considerations or resource limitations. This chapter applies to individuals living in the community, FRCs, and SRCs.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Components of the IP."> <paragraph num="A."> <text>The IP is:</text> <paragraph num="(1)"> <text>A single plan for the provision of services and supports to the individual;</text> </paragraph> <paragraph num="(2)"> <text>Directed by the individual;</text> </paragraph> <paragraph num="(3)"> <text>Outcome oriented; and</text> </paragraph> <paragraph num="(4)"> <text>Intended to specify all needed assessments, services, and training.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The IP is a written plan which includes:</text> <paragraph num="(1)"> <text>Strengths and needs of the individual;</text> </paragraph> <paragraph num="(2)"> <text>Preferences and desires identified by and for the individual;</text> </paragraph> <paragraph num="(3)"> <text>Services to be provided to the individual by the licensee, such as:</text> <paragraph num="(a)"> <text>Habilitation;</text> </paragraph> <paragraph num="(b)"> <text>Medical;</text> </paragraph> <paragraph num="(c)"> <text>Occupational therapy;</text> </paragraph> <paragraph num="(d)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(e)"> <text>Social;</text> </paragraph> <paragraph num="(f)"> <text>Psychological;</text> </paragraph> <paragraph num="(g)"> <text>Audiological;</text> </paragraph> <paragraph num="(h)"> <text>Speech and language;</text> </paragraph> <paragraph num="(i)"> <text>Nursing;</text> </paragraph> <paragraph num="(j)"> <text>Assistive technology; and</text> </paragraph> <paragraph num="(k)"> <text>Additional services to support an individual in retirement;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A behavior plan, if required;</text> </paragraph> <paragraph num="(5)"> <text>Specific training and staffing ratios based on the needs, preferences, and desires of the individual;</text> </paragraph> <paragraph num="(6)"> <text>Measurable goals for the completion of outcomes;</text> </paragraph> <paragraph num="(7)"> <text>Target dates for the completion of goals;</text> </paragraph> <paragraph num="(8)"> <text>Implementation strategies and dates;</text> </paragraph> <paragraph num="(9)"> <text>Documentation of progress toward the achievement of goals;</text> </paragraph> <paragraph num="(10)"> <text>Monitoring procedures;</text> </paragraph> <paragraph num="(11)"> <text>Individuals responsible for providing the supports, services, implementation, and monitoring of the plan;</text> </paragraph> <paragraph num="(12)"> <text>Documentation indicating that the individual or the individual's proponents, when applicable, have been involved in, informed of, and agree with the plan;</text> </paragraph> <paragraph num="(13)"> <text>A determination of whether the needs of the individual could be met in more integrated settings; and</text> </paragraph> <paragraph num="(14)"> <text>For individuals residing in a State residential center, the written plan of habilitation consisting of:</text> <paragraph num="(a)"> <text>The treating professional's recommendation on the most integrated setting appropriate to meet the individual's needs;</text> </paragraph> <paragraph num="(b)"> <text>The resource coordinator's recommendation on the most integrated setting appropriate to meet the individual's needs;</text> </paragraph> <paragraph num="(c)"> <text>A description of the services and supports, including residential, day, employment, and technology, that are required for the individual to receive services in the most integrated setting;</text> </paragraph> <paragraph num="(d)"> <text>A listing of barriers that prevent the individual from receiving supports and services in the most integrated setting, including community capacity or systems, if community services are determined to be the most integrated setting appropriate to meet the individual's needs; and</text> </paragraph> <paragraph num="(e)"> <text>An annual update on the status and progress toward addressing and resolving any identified barriers to receiving supports and services in the most integrated setting.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Development and Implementation."> <paragraph num="A."> <text>The resource coordinator, as defined in COMAR 10.22.09, shall ensure that:</text> <paragraph num="(1)"> <text>Each individual, other than an individual receiving respite services in the community, has an IP that is developed not more than 30 calendar days after receiving services;</text> </paragraph> <paragraph num="(2)"> <text>The IP is developed in a manner consistent with the values and outcomes in COMAR 10.22.04, and the provisions of any other relevant State or federal laws;</text> </paragraph> <paragraph num="(3)"> <text>Each individual is provided with a range of the most integrated setting service options that may be appropriate; and</text> </paragraph> <paragraph num="(4)"> <text>The IP meetings are held at a time and place convenient to the individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the individual does not have a resource coordinator, the licensee, in the following priority order, shall ensure that the requirements of this chapter are met:</text> <paragraph num="(1)"> <text>Community residential services licensee;</text> </paragraph> <paragraph num="(2)"> <text>Vocational or day services licensee; or</text> </paragraph> <paragraph num="(3)"> <text>Family and individual support services licensee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Written Plan of Habilitation for Individuals Residing in State Residential Center.</text> <paragraph num="(1)"> <text>The individual, a treating professional, and a resource coordinator shall develop the written plan of habilitation.</text> </paragraph> <paragraph num="(2)"> <text>On an annual basis and any other time requested by the individual, the treating professional and the resource coordinator shall discuss with the individual:</text> <paragraph num="(a)"> <text>The service and support needs of the individual;</text> </paragraph> <paragraph num="(b)"> <text>A range of the most integrated setting service options licensed through the administration that may be appropriate; and</text> </paragraph> <paragraph num="(c)"> <text>Any identified community-based Medicaid waiver services and any other services and supports that may be appropriate.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The treating professionals and resource coordinator shall use any communication devices and techniques, including the use of sign language, as appropriate, to facilitate the involvement of the individual in the development of the written plan of habilitation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Decisions."> <paragraph num="A."> <text>The team shall make decisions by consensus.</text> </paragraph> <paragraph num="B."> <text>If the team cannot reach a consensus, the resource coordinator shall mediate and resolve the issue of concern.</text> </paragraph> <paragraph num="C."> <text>If the resource coordinator cannot resolve the issue or if there is not a resource coordinator on the team, the appropriate regional director shall mediate and resolve the issue of concern.</text> </paragraph> <paragraph num="D."> <text>For individuals residing in a State residential center:</text> <paragraph num="(1)"> <text>If the team cannot reach consensus, the facility director shall mediate and resolve the issue of concern; and</text> </paragraph> <paragraph num="(2)"> <text>If consensus still cannot be achieved, the regional director shall mediate and resolve the issue of concern.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Review of the IP."> <paragraph num="A."> <text>Each IP shall be reviewed and approved, disapproved, or modified by:</text> <paragraph num="(1)"> <text>The executive officer or administrative head of the licensee or a qualified developmental disability professional whom the executive officer or administrative head designates; and</text> </paragraph> <paragraph num="(2)"> <text>One other professional individual who is responsible for carrying out a major program but does not participate in the IP.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Approval of an IP shall be based on the current needs of the individual.</text> </paragraph> <paragraph num="C."> <text>The team shall review each IP at least annually, or more often as needed, and modify each IP as required by the individual's circumstances.</text> </paragraph> <paragraph num="D."> <text>Any member of the team may request a review or modification of the IP at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Implementation."> <text>The licensee shall implement the supports and services that the licensee has agreed to provide, as indicated in the IP, within 20 calendar days.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-1002 and 7-1006, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 13, 1977 (4:8 Md. R. 643)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06 repealed effective November 14, 1988 (15:23 Md. R. 2659)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09, Individualized Habilitation Plans, adopted effective November 14, 1988 (15:23 Md. R. 2659)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Individualized Habilitation Plans, repealed and new chapter, The Individual Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C adopted effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> </annotations> </chapter> <chapter num="06" heading="Family and Individual Support Services (FISS) Program Service Plan"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who provides FISS to an individual shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.02, with the exception of COMAR 10.22.02.06;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.03;</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.04;</text> </paragraph> <paragraph num="E."> <text>COMAR 10.22.05; and</text> </paragraph> <paragraph num="F."> <text>COMAR 10.22.10, when applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>Services are to be flexible and dynamic to meet the needs of individuals or families desiring specific areas of support and for those who have changing needs.</text> </paragraph> <paragraph num="B."> <text>Services are to be readily adaptable to the changing needs of the individual.</text> </paragraph> <paragraph num="C."> <text>The flexibility inherent in FISS lends itself to creative and innovative ways of supporting individuals and their families.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <paragraph num="A."> <text>FISS cover a wide array of supports in the life of an individual.</text> </paragraph> <paragraph num="B."> <text>FISS are provided by making use of resources available in the community while, at the same time, building on the individual's existing support network.</text> </paragraph> <paragraph num="C."> <text>Supports are the assistance provided to the individual to enable participation in the community. Supports are integral to each individual or family's quality of life and often enhance the lives of those involved.</text> </paragraph> <paragraph num="D."> <text>FISS may include, but are not limited to, supports involving:</text> <paragraph num="(1)"> <text>Budgeting;</text> </paragraph> <paragraph num="(2)"> <text>Medication administration;</text> </paragraph> <paragraph num="(3)"> <text>Counseling;</text> </paragraph> <paragraph num="(4)"> <text>Job coaching;</text> </paragraph> <paragraph num="(5)"> <text>Helping an individual to access and complete the individual's education;</text> </paragraph> <paragraph num="(6)"> <text>Participating in recreational and social activities;</text> </paragraph> <paragraph num="(7)"> <text>Accessing community services;</text> </paragraph> <paragraph num="(8)"> <text>Grocery shopping;</text> </paragraph> <paragraph num="(9)"> <text>Respite, behavioral, and other services and supports needed by the family of the individual; and</text> </paragraph> <paragraph num="(10)"> <text>Developing relationships.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing and Training."> <paragraph num="A."> <text>The individual's plan determines the amount of staff time, pattern of supports, and type of staff training needed to support each individual or family.</text> </paragraph> <paragraph num="B."> <text>The licensee shall ensure that staff:</text> <paragraph num="(1)"> <text>Have the necessary skills to carry out the individual's plan; and</text> </paragraph> <paragraph num="(2)"> <text>Receive training in accordance with COMAR 10.22.02.11.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Setting and Location."> <paragraph num="A."> <text>The licensee shall provide FISS within the context of each individual or family's life style in the least intrusive manner possible.</text> </paragraph> <paragraph num="B."> <text>The licensee shall provide FISS consistent with each individual's IP.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-703, 7-708, and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 7, 1980 (7:5 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09, Respite Care Services in Public Residential Care Facilities Serving the Mentally Retarded, repealed effective June 13, 1988 (15:12 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08, Respite Care Services in State Residential Centers Serving Individuals with Mental Retardation, adopted effective June 13, 1988 (15:12 Md. R. 1445)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Respite Care Services in State Residential Centers Serving Individuals with Mental Retardation, repealed and new chapter, Family and Individual Support Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> </annotations> </chapter> <chapter num="07" heading="Vocational and Day Services Program Service Plan"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who provides vocational or day services to an individual shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.02, except COMAR 10.22.02.07;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.03;</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.04;</text> </paragraph> <paragraph num="E."> <text>COMAR 10.22.05; and</text> </paragraph> <paragraph num="F."> <text>COMAR 10.22.10, when applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>Individuals often need assistance to obtain and maintain work in the community. With supports, job skills are learned and behavior appropriate for the workplace is increased. Work in the community provides income, self-esteem, and personal value for the individual.</text> </paragraph> <paragraph num="B."> <text>Individuals seeking to obtain and maintain work in the community are free to choose preferred types of work, to seek change of work when not satisfied, and have their day activities reflect the needs, preferences, and desires stated in their IPs, including the ability to combine day or vocational services with other community activities, such as school or recreation.</text> </paragraph> <paragraph num="C."> <text>A licensee may not limit an individual to specific types of services because of their ages, severity of disability, or level of supports needed to work.</text> </paragraph> <paragraph num="D."> <text>A licensee shall use accommodation, coaching, individual choice, and preferences in matching individuals and employment opportunities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <paragraph num="A."> <text>The vocational or day services licensee shall respond to individual needs and preferences in accordance with the IP.</text> </paragraph> <paragraph num="B."> <text>Current program models include:</text> <paragraph num="(1)"> <text>Supported employment;</text> </paragraph> <paragraph num="(2)"> <text>Vocational services;</text> </paragraph> <paragraph num="(3)"> <text>Day habilitation; and</text> </paragraph> <paragraph num="(4)"> <text>Volunteer work.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Supported Employment.</text> <paragraph num="(1)"> <text>Supported employment includes:</text> <paragraph num="(a)"> <text>Individuals who are self-employed and need supports, or are working in community businesses for pay with licensee funded supports; or</text> </paragraph> <paragraph num="(b)"> <text>Any work program except one in an SRC that includes supports necessary for the individual to achieve the desired outcomes established in the IP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee shall provide job skill training which includes but is not limited to:</text> <paragraph num="(a)"> <text>Skills required to perform a job;</text> </paragraph> <paragraph num="(b)"> <text>Community mobility training;</text> </paragraph> <paragraph num="(c)"> <text>Guidance in acceptable job behaviors; and</text> </paragraph> <paragraph num="(d)"> <text>Job seeking and interviewing skills.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual typically works 20 — 40 hours per week, not including commuting time.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Vocational Services.</text> <paragraph num="(1)"> <text>Vocational services include but are not limited to:</text> <paragraph num="(a)"> <text>Vocational assessment activities;</text> </paragraph> <paragraph num="(b)"> <text>Job training, work skill training, and placement programs;</text> </paragraph> <paragraph num="(c)"> <text>Training in social skills, acceptable work behaviors, and other skills such as money management;</text> </paragraph> <paragraph num="(d)"> <text>Basic safety skills;</text> </paragraph> <paragraph num="(e)"> <text>Training in work-related hygiene; and</text> </paragraph> <paragraph num="(f)"> <text>Work skills.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A vocational services licensee shall provide services at a minimum:</text> <paragraph num="(a)"> <text>220 days per year;</text> </paragraph> <paragraph num="(b)"> <text>5 days a week;</text> </paragraph> <paragraph num="(c)"> <text>6 hours a day not including commuting time; or</text> </paragraph> <paragraph num="(d)"> <text>Consistent with an alternative schedule approved by the Director.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Day Habilitation.</text> <paragraph num="(1)"> <text>Day habilitation includes individuals participating in structured activities designed to increase or maintain:</text> <paragraph num="(a)"> <text>Motor skills;</text> </paragraph> <paragraph num="(b)"> <text>Communication skills;</text> </paragraph> <paragraph num="(c)"> <text>Personal hygiene skills;</text> </paragraph> <paragraph num="(d)"> <text>Leisure skills; and</text> </paragraph> <paragraph num="(e)"> <text>Community integration.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee providing day habilitation shall provide services at a minimum:</text> <paragraph num="(a)"> <text>220 days per year;</text> </paragraph> <paragraph num="(b)"> <text>5 days a week;</text> </paragraph> <paragraph num="(c)"> <text>6 hours per day not including commuting time; or</text> </paragraph> <paragraph num="(d)"> <text>Consistent with an alternative schedule approved by the Director.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Volunteer Work.</text> <paragraph num="(1)"> <text>Volunteer work enables the individual to gain desired work experience, personal satisfaction, and to contribute to the community.</text> </paragraph> <paragraph num="(2)"> <text>The individual and the individual's team shall evaluate, at least annually, the appropriateness and continued desirability of the volunteer placement over paid work activities.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Transportation Services.</text> <paragraph num="(1)"> <text>The licensee is responsible for assisting or arranging transportation services with the individual.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall use the mode of transportation which achieves the least costly, and most appropriate, means of transportation for the individual with priority given to the use of public transportation, when appropriate.</text> </paragraph> <paragraph num="(3)"> <text>An individual who lives within walking distance of the program or worksite and who is sufficiently mobile shall be encouraged to walk.</text> </paragraph> <paragraph num="(4)"> <text>The licensee shall keep accurate records which clearly indicate the transportation that the individual uses to participate in the vocational or day service including an alternative transportation plan if the primary plan is unavailable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing and Training."> <paragraph num="A."> <text>Staffing levels shall be determined by the IP with the licensee providing the staff for each individual as indicated in the IP.</text> </paragraph> <paragraph num="B."> <text>The licensee shall ensure that staff receive training in accordance with COMAR 10.22.02.11.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Setting and Location."> <paragraph num="A."> <text>Integrated work settings are preferred.</text> </paragraph> <paragraph num="B."> <text>A licensee providing services under this chapter shall make every effort to provide services that are integrated in neighborhoods and communities.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-903 and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 20, 1986 (13:21 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — 07, Fundamental Rights, repealed effective June 27, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07, Fundamental Rights of Individuals, adopted effective June 27, 1988 (15:13 Md. R. 1554)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Fundamental Rights of Individuals, repealed and new chapter, Vocational and Day Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> </annotations> </chapter> <chapter num="08" heading="Community Residential Services Program Service Plan"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who provides residential services to an individual shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.02;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.03;</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.04;</text> </paragraph> <paragraph num="E."> <text>COMAR 10.22.05; and</text> </paragraph> <paragraph num="F."> <text>COMAR 10.22.10, when applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>Living in the community involves both a wide range of skills and choices about life style.</text> </paragraph> <paragraph num="B."> <text>Community residential models accommodate the wide range of choices individuals and their families make about how to live in the community.</text> </paragraph> <paragraph num="C."> <text>Community residential models are designed to give preference to small and individualized settings.</text> </paragraph> <paragraph num="D."> <text>Individuals with developmental disabilities have the same range of options about where to live in the community as are available to all people.</text> </paragraph> <paragraph num="E."> <text>The Administration respects personal choice regarding decisions about where and with whom individuals with developmental disabilities may live.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <paragraph num="A."> <text>Current community residential service models include:</text> <paragraph num="(1)"> <text>Alternative living units (ALU);</text> </paragraph> <paragraph num="(2)"> <text>Group homes;</text> </paragraph> <paragraph num="(3)"> <text>Individual family care homes (IFC); and</text> </paragraph> <paragraph num="(4)"> <text>Community supported living arrangements (CSLA).</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall make every effort to provide services to an individual according to the individual's choices as identified in the IP.</text> </paragraph> <paragraph num="C."> <text>The range of community residential service options available to an individual may be limited by resources or lack of available sites.</text> </paragraph> <paragraph num="D."> <text>For transportation services other than those outlined in COMAR 10.22.07.03G, a licensee shall provide or arrange for the provision of the use of transportation services.</text> </paragraph> <paragraph num="E."> <text>Respite Services.</text> <paragraph num="(1)"> <text>A site may be licensed to accommodate additional individuals for respite services.</text> </paragraph> <paragraph num="(2)"> <text>Respite services for an individual:</text> <paragraph num="(a)"> <text>May not exceed 45 days within any 1-year period;</text> </paragraph> <paragraph num="(b)"> <text>May not be provided for more than 28 consecutive days;</text> </paragraph> <paragraph num="(c)"> <text>May not be provided unless the licensee is provided with current health, emergency, and any other information that is essential to the licensee's ability to provide appropriate care for the individual; and</text> </paragraph> <paragraph num="(d)"> <text>May be provided for IFC care providers only to the extent permitted by the IFC care provider contract.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A licensee providing respite services shall:</text> <paragraph num="(1)"> <text>Ensure that the health and safety needs of the individual are met; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with COMAR 10.22.04 and 10.22.05 if the individual has an IP, and 10.22.10 if the individual has a behavior plan.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing and Training."> <paragraph num="A."> <text>A licensee shall provide staffing levels and patterns as determined in the IP.</text> </paragraph> <paragraph num="B."> <text>A licensee shall provide or arrange for the provision of training in accordance with COMAR 10.22.02.11.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Setting and Location."> <paragraph num="A."> <text>An individual may receive services under this chapter in the individual's own home, in the family's home, in a current residential service model, or in any other service model approved by the Director in accordance with COMAR 10.22.02.09F.</text> </paragraph> <paragraph num="B."> <text>A licensee providing services under this chapter shall make every effort to provide services that are integrated in neighborhoods and communities.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-714, 7-903, and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 26, 1999 (26:15 Md. R. 1148)</annotation> </annotations> </chapter> <chapter num="09" heading="Resource Coordination Program Service Plan"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who provides resource coordination to an individual shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.02, except COMAR 10.22.02.05, .06, .07, .11, .12, and .14E(1)(d);</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.03;</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.04; and</text> </paragraph> <paragraph num="E."> <text>COMAR 10.22.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>Resource coordination is provided by a resource coordinator.</text> </paragraph> <paragraph num="B."> <text>The resource coordinator assists individuals in obtaining the best quality and most appropriate services and supports within available resources.</text> </paragraph> <paragraph num="C."> <text>The resource coordinator is responsible to individuals and their families for providing assistance in implementing individual choice, addressing individual satisfaction, and assuring that an individual's needs and preferences are addressed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <paragraph num="A."> <text>Resource coordination may be provided to individuals determined eligible for services from the Administration, including individuals on the waiting list.</text> </paragraph> <paragraph num="B."> <text>Resource coordination may only be provided by licensees who do not provide direct services to individuals.</text> </paragraph> <paragraph num="C."> <text>The level and intensity of resource coordination may vary according to the individual's needs and desire for resource coordination.</text> </paragraph> <paragraph num="D."> <text>In the State residential center, a resource coordinator shall be provided for all individuals for the purpose of participating in the development of the written plan of habilitation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Functions of the Resource Coordination Licensee."> <text>The resource coordination licensee shall carry out the following functions:</text> <paragraph num="A."> <text>Determine an individual's needs, preferences, desires, satisfaction, and the most integrated setting appropriate to meet the individual's needs;</text> </paragraph> <paragraph num="B."> <text>Assist the individual through planning in choosing goals and outcomes, the services needed to accomplish these goals and outcomes, and the establishment of realistic time frames for meeting these goals and outcomes;</text> </paragraph> <paragraph num="C."> <text>Broker services in consultation with the regional office to obtain generic services, services funded by the Administration, and natural supports;</text> </paragraph> <paragraph num="D."> <text>Advocate for the individual to assure that the individual's rights are protected and the individual's needs and preferences are considered;</text> </paragraph> <paragraph num="E."> <text>Monitor and act as a third-party advocate for implementation of the IP; and</text> </paragraph> <paragraph num="F."> <text>If requested by the Administration, provide utilization review of services being provided to individuals.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of the Resource Coordinator."> <paragraph num="A."> <text>The resource coordinator is responsible for:</text> <paragraph num="(1)"> <text>Ensuring that each individual receives an IP that is designed to meet the individual's needs, preferences, desires, goals, and outcomes in the most integrated setting appropriate to meet the individual's needs and in the most cost effective manner;</text> </paragraph> <paragraph num="(2)"> <text>Documenting that the IP is being implemented as designed;</text> </paragraph> <paragraph num="(3)"> <text>Communicating information with the Administration in an effort to achieve a responsive service delivery system;</text> </paragraph> <paragraph num="(4)"> <text>Assisting the individual in applying for services; and</text> </paragraph> <paragraph num="(5)"> <text>Providing education to individuals and their families concerning:</text> <paragraph num="(a)"> <text>The range of most integrated setting service and support options that may be appropriate to meet the individual's needs;</text> </paragraph> <paragraph num="(b)"> <text>How to access services, and</text> </paragraph> <paragraph num="(c)"> <text>How to coordinate and advocate for services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Resource coordinators shall have personal knowledge of each individual served and make every effort to effectively accommodate the individual's needs and preferences.</text> </paragraph> <paragraph num="C."> <text>Resource coordinators shall personally meet with each individual served, at least every 6 months, in an effort to effectively meet the individual's needs and preferences.</text> </paragraph> <paragraph num="D."> <text>In the State residential center, the resource coordinator shall:</text> <paragraph num="(1)"> <text>Ensure that communication devices and techniques, including the use of sign language, as appropriate, are used to facilitate the involvement of the individual in the development of the written plan of habilitation;</text> </paragraph> <paragraph num="(2)"> <text>Recommend the most integrated setting appropriate to meet the individual's needs; and</text> </paragraph> <paragraph num="(3)"> <text>Conduct an annual update on the status and progress toward addressing and resolving the barriers to receiving services and supports in the most integrated setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Staffing and Training."> <paragraph num="A."> <text>A resource coordinator shall have the skills necessary to:</text> <paragraph num="(1)"> <text>Determine the most integrated setting appropriate to meet the individual's needs;</text> </paragraph> <paragraph num="(2)"> <text>Coordinate planning meetings;</text> </paragraph> <paragraph num="(3)"> <text>Negotiate and resolve conflicts;</text> </paragraph> <paragraph num="(4)"> <text>Assist individuals in gaining access to services and supports;</text> </paragraph> <paragraph num="(5)"> <text>Coordinate services; and</text> </paragraph> <paragraph num="(6)"> <text>Monitor the provision of services to individuals.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The resource coordination licensee shall ensure through appropriate documentation that the resource coordinator receives training in:</text> <paragraph num="(1)"> <text>Fundamental rights;</text> </paragraph> <paragraph num="(2)"> <text>Communication skills;</text> </paragraph> <paragraph num="(3)"> <text>Specific disabilities of the individuals the resource coordinator serves;</text> </paragraph> <paragraph num="(4)"> <text>Development of the IP;</text> </paragraph> <paragraph num="(5)"> <text>Facilitating individual choice;</text> </paragraph> <paragraph num="(6)"> <text>Determining individual satisfaction; and</text> </paragraph> <paragraph num="(7)"> <text>Developing opportunities for individuals to establish relationships, friendships, and connections in the community.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Setting."> <text>To the extent feasible, individuals may select:</text> <paragraph num="A."> <text>Their own resource coordinator; and</text> </paragraph> <paragraph num="B."> <text>The time, place, and frequency of meetings.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-903 and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 25, 1986 (13:17 Md. R. 1922)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Services Coordination Programs for Mentally Retarded and Nonretarded Developmentally Disabled Individuals, repealed and new chapter, Resource Coordination Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective May 5, 2008 (35:9 Md. R. 897)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective May 5, 2008 (35:9 Md. R. 897)</annotation> </annotations> </chapter> <chapter num="10" heading="Behavior Support Services Program Service Plan"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who provides behavior support services to an individual shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.02;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.03;</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.04; and</text> </paragraph> <paragraph num="E."> <text>COMAR 10.22.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>The Administration serves individuals who exhibit challenging behaviors and require a variety of supports to achieve success in exercising the individual's choices responsibly.</text> </paragraph> <paragraph num="B."> <text>Behavior support services are designed to assist individuals who exhibit challenging behaviors in acquiring skills, gaining social acceptance, and becoming full participants in the community.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <paragraph num="A."> <text>A licensee who provides services to an individual in the community or in an SRC whose record indicates a need for a behavior plan shall meet the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>A licensee who contracts for behavior support services shall ensure that its contractor meets the requirements of this chapter and is knowledgeable about the Administration's service delivery system.</text> </paragraph> <paragraph num="C."> <text>Behavior support services include:</text> <paragraph num="(1)"> <text>Behavioral consultation;</text> </paragraph> <paragraph num="(2)"> <text>Temporary augmentation of staff;</text> </paragraph> <paragraph num="(3)"> <text>Behavioral training; and</text> </paragraph> <paragraph num="(4)"> <text>Behavioral respite services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing and Training."> <text>In addition to the training requirements in COMAR 10.22.02.11A — D, the licensee shall ensure that staff who provide behavior support services, before being assigned independent duties, receive training in the:</text> <paragraph num="A."> <text>Principles of behavioral change; and</text> </paragraph> <paragraph num="B."> <text>Appropriate methods of preventing or managing challenging behaviors, which may include the use of mechanical restraints.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Behavior Plan (BP)."> <paragraph num="A."> <text>A licensee shall ensure that a BP is developed for each individual for whom it is required.</text> </paragraph> <paragraph num="B."> <text>The licensee shall ensure the BP:</text> <paragraph num="(1)"> <text>Is developed, in conjunction with the team, by a licensed psychologist, psychology associate under the supervision of a licensed psychologist, licensed behavior analyst, licensed physician, licensed certified social worker, or licensed or certified professional counselor, who shall have training and experience in applied behavior analysis;</text> </paragraph> <paragraph num="(2)"> <text>Is based on and includes a functional analysis or assessment of each challenging behavior as identified in the IP;</text> </paragraph> <paragraph num="(3)"> <text>Specifies the behavioral objectives for the individual, and includes:</text> <paragraph num="(a)"> <text>A description of the hypothesized function of current behaviors including their frequency and severity; and</text> </paragraph> <paragraph num="(b)"> <text>Criteria for determining achievement of the objectives established;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Takes into account the medical condition of the individual;</text> </paragraph> <paragraph num="(5)"> <text>Describes the treatment techniques and when the techniques are to be used;</text> </paragraph> <paragraph num="(6)"> <text>Specifies the emergency procedures to be implemented for the individual with a history of exhibiting behaviors that present a danger to self or serious bodily harm to others;</text> </paragraph> <paragraph num="(7)"> <text>Includes a description of the adaptive skills to be learned by the individual that serve as functional alternatives to the challenging behavior or behaviors to be decreased;</text> </paragraph> <paragraph num="(8)"> <text>Identifies the person or persons responsible for monitoring the BP;</text> </paragraph> <paragraph num="(9)"> <text>Specifies the data to be collected to assess progress towards meeting the BP's objectives; and</text> </paragraph> <paragraph num="(10)"> <text>Describes and documents each use of mechanical and physical restraint, the reason for its use, and the length of time used.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before implementation, the licensee shall ensure that each behavior plan which includes the use of restrictive techniques is:</text> <paragraph num="(1)"> <text>Approved by the standing committee as specified in COMAR 10.22.02.14E(1)(d); and</text> </paragraph> <paragraph num="(2)"> <text>Includes written informed consent of the:</text> <paragraph num="(a)"> <text>Individual;</text> </paragraph> <paragraph num="(b)"> <text>Individual's legal guardian; or</text> </paragraph> <paragraph num="(c)"> <text>Surrogate decision maker as defined n Health-General Article, §5-605, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Before a licensee discontinues a behavior plan, the team and an individual appropriately licensed under Health Occupations Article with training and experience in applied behavior analysis shall recommend that the individual no longer needs a behavior plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Use of Restrictive Techniques."> <paragraph num="A."> <text>The licensee shall ensure that the use of restrictive techniques in any BP:</text> <paragraph num="(1)"> <text>Represents the least restrictive, effective alternative, or the lowest effective dose of a medication; and</text> </paragraph> <paragraph num="(2)"> <text>Is only implemented after other methods have been:</text> <paragraph num="(a)"> <text>Systematically tried, and</text> </paragraph> <paragraph num="(b)"> <text>Objectively determined to be ineffective.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee shall collect and present objective data to the authorizing licensed health care practitioner to indicate whether the restrictive technique being used is effective in reducing the individual's challenging behavior.</text> </paragraph> <paragraph num="C."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Convene the team within 5 calendar days after an emergency use of a restrictive technique to review the situation and action taken;</text> </paragraph> <paragraph num="(2)"> <text>Determine subsequent action include whether the development or modification of a BP is necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Document that the requirements of this regulation have been met.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The licensee shall ensure that staff do not use:</text> <paragraph num="(1)"> <text>Any method or technique prohibited by law, including aversive techniques;</text> </paragraph> <paragraph num="(2)"> <text>Any method or technique which deprives an individual of any basic right specified in Health-General Article, §§7-1002—7-1004, Annotated Code of Maryland, except as permitted in COMAR 10.22.04.03A;</text> </paragraph> <paragraph num="(3)"> <text>Seclusion;</text> </paragraph> <paragraph num="(4)"> <text>A room from which egress is prevented; or</text> </paragraph> <paragraph num="(5)"> <text>A program which results in a nutritionally inadequate diet.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Staff may not use a restrictive technique:</text> <paragraph num="(1)"> <text>As a substitute for a treatment plan;</text> </paragraph> <paragraph num="(2)"> <text>As punishment; or</text> </paragraph> <paragraph num="(3)"> <text>For convenience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Use of Medications to Modify Challenging Behavior."> <paragraph num="A."> <text>In addition to the requirements in Regulations .05 and .06 of this chapter, the licensee shall ensure that a BP which includes the use of medication includes:</text> <paragraph num="(1)"> <text>The specific medications that have been prescribed;</text> </paragraph> <paragraph num="(2)"> <text>The rationale for prescribing each medication;</text> </paragraph> <paragraph num="(3)"> <text>Any alternate methods of management being used to bring challenging behavior under control; and</text> </paragraph> <paragraph num="(4)"> <text>Objective data collected by staff and presented to the licensed health care practitioner to indicate that the medication being used is effective in reducing the individual's challenging behavior.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee shall ensure that a licensed health care practitioner documents that:</text> <paragraph num="(1)"> <text>Any potential side effect from the medication outweighs the behavior that will occur without the use of the medication; and</text> </paragraph> <paragraph num="(2)"> <text>Attempts are being made to gradually decrease the dosage or discontinue the medication when clinically indicated.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensed health care practitioner shall review any medication that has been prescribed to modify behavior at a minimum of every 90 days.</text> </paragraph> <paragraph num="D."> <text>PRN orders for medications to modify behavior are prohibited.</text> </paragraph> <paragraph num="E."> <text>Medications to modify behavior may not be used in quantities that interfere with an individual's ability to participate in daily living activities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Use of Physical Restraint."> <paragraph num="A."> <text>Physical restraint may only be used when the individual's behavior presents a danger to self or serious bodily harm to others.</text> </paragraph> <paragraph num="B."> <text>The licensee shall ensure that only staff who have been trained in the management of disruptive behavior, or other curriculum approved by the Administration, may use a physical restraint and may only do so as specified in the curriculum.</text> </paragraph> <paragraph num="C."> <text>In addition to the requirements in Regulation .06 of this chapter, the licensee shall document in the individual's record each use of a physical restraint, including the reason for its use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Use of Mechanical Restraint and Support."> <paragraph num="A."> <text>Use of Mechanical Restraint for Behavioral Purposes.</text> <paragraph num="(1)"> <text>A mechanical restraint may only be used:</text> <paragraph num="(a)"> <text>To prevent an individual from engaging in self-injurious behaviors such as head banging, teeth gnashing, and similar behavior;</text> </paragraph> <paragraph num="(b)"> <text>To prevent serious bodily harm to others; or</text> </paragraph> <paragraph num="(c)"> <text>As required by an individual's treating licensed health care practitioner to allow an individual to recuperate from surgery or injury.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee shall ensure that a mechanical restraint is designed and used:</text> <paragraph num="(a)"> <text>In a humane, safe, and effective manner; and</text> </paragraph> <paragraph num="(b)"> <text>Without intent to harm or create undue discomfort.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a mechanical restraint is being used for the purpose of §A(1)(a) and (b) of this regulation, the licensee shall:</text> <paragraph num="(a)"> <text>Meet the requirements in Regulations .05 and 06 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Obtain written authorization from a licensed health care practitioner trained in applied behavior analysis for the use of the mechanical restraint, including the duration of its use and the circumstances under which the restraint is authorized;</text> </paragraph> <paragraph num="(c)"> <text>Document in the individual's record each use of mechanical restraint, including the reason for its use; and</text> </paragraph> <paragraph num="(d)"> <text>Require staff to check on the individual every 15 minutes.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When a mechanical restraint is being used for the purpose of §A(1)(a) and (b) of this regulation, the licensee shall afford the individual the opportunity:</text> <paragraph num="(a)"> <text>To be escorted to the bathroom and offered fluids at least every 2 hours;</text> </paragraph> <paragraph num="(b)"> <text>For motion and exercise for a period of not less than 10 minutes during each 2 hours in which the restraint is used; and</text> </paragraph> <paragraph num="(c)"> <text>To be provided meals at regularly scheduled hours.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A licensed health care practitioner who authorized the use of the mechanical restraint shall review the authorization at a minimum of every 90 days, and document its effectiveness and whether continuation is indicated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Use of Mechanical Restraint for Medical Purposes. If a mechanical restraint is being used for the purpose of §A(1)(c) of this regulation, the licensee shall:</text> <paragraph num="(1)"> <text>Obtain written authorization from the individual's treating licensed health care practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>Document in the individual's record the reason and guidelines for the use of the restraint, including the time frame the mechanical restraint is to be used.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Use of a Mechanical Support.</text> <paragraph num="(1)"> <text>A mechanical support may only be used if authorized by a licensed health care practitioner.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall ensure that a mechanical support is designed and used:</text> <paragraph num="(a)"> <text>In a humane, safe, and effective manner; and</text> </paragraph> <paragraph num="(b)"> <text>Without intent to harm or create undue discomfort.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The licensee shall document in the individual's record the reason for use of the mechanical support, when it is to be used, and the directions for its use.</text> </paragraph> <paragraph num="(4)"> <text>The licensed health care practitioner who authorized the use of the mechanical support shall document its effectiveness and whether continuation is indicated, at least, on an annual basis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Use of Chemical Restraint."> <paragraph num="A."> <text>Chemical restraint may only be used when the individual's behavior presents a danger to self or serious bodily harm to others.</text> </paragraph> <paragraph num="B."> <text>A licensee may only use a chemical restraint in a behavioral emergency when:</text> <paragraph num="(1)"> <text>Ordered by a licensed health care practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>Administered and monitored by a licensed health care practitioner.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements in Regulation .06 of this chapter, the licensee shall document in the individual's record the use of any chemical restraint, including the reason for its use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Monitoring Use of Medications to Modify Behavior and Restrictive Techniques."> <text>The licensee shall monitor the use of restrictive techniques through its internal quality assurance process as required by COMAR 10.22.02.14B(4).</text> </regulation> <regulation prefix="Regulation" num=".12" heading="IBMP — Alternative Living Arrangements."> <text>After the effective date of this chapter, a licensee providing residential services which specializes in behavior support services shall comply with the requirements of this chapter and COMAR 10.22.08.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-904; Health Occupations Article, §17-6A-01 et seq.; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 29, 1985 (12:15 Md. R. 1517)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 repealed effective January 23, 1989 (16:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .11 adopted effective January 23, 1989 (16:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended as an emergency provision effective May 3, 1989 (16:10 Md. R. 1102); adopted permanently effective October 30, 1989 (16:21 Md. R. 2261)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09G amended effective January 6, 1992 (18:26 Md. R. 2830)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Intensive Behavior Management and Other Programs Utilizing Behavior Management Techniques, repealed and new chapter, Behavior Support Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 30, 2017 (44:2 Md. R. 85)</annotation> </annotations> </chapter> <chapter num="11" heading="Respite Services in the State Residential Center (SRC)"> <regulation prefix="Regulation" num=".01" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, an SRC providing respite services shall comply with the following regulations of this subtitle:</text> <paragraph num="A."> <text>COMAR 10.22.01;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.04;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.05; and</text> </paragraph> <paragraph num="D."> <text>COMAR 10.22.10.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose."> <text>This chapter addresses the provision of respite services in the SRC for individuals currently living in the community.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Provision of Services."> <text>Before respite services are utilized in the SRC, all efforts are made by the Administration to provide individuals living in the community with respite services in the community. Only when there are no other appropriate alternatives available are respite services provided in the SRC.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Eligibility."> <text>To be eligible to receive respite care in the SRC, the individual:</text> <paragraph num="A."> <text>Shall be eligible to receive services funded by the Administration;</text> </paragraph> <paragraph num="B."> <text>Shall have an appropriate evaluation with the diagnosis of an intellectual disability;</text> </paragraph> <paragraph num="C."> <text>Shall have needs that are able to be met effectively while at the SRC; and</text> </paragraph> <paragraph num="D."> <text>May not be in receipt of full residential services in a community program, except with the approval of the Director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Length of Stay."> <text>Respite services in the SRC may only be provided to an individual for not more than:</text> <paragraph num="A."> <text>45 days per calendar year; or</text> </paragraph> <paragraph num="B."> <text>28 consecutive days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Procedures for Respite Requests."> <paragraph num="A."> <text>The individual's proponent or licensee shall direct requests for respite services to the appropriate regional office.</text> </paragraph> <paragraph num="B."> <text>The regional office shall arrange for the following:</text> <paragraph num="(1)"> <text>The completion of a formal application;</text> </paragraph> <paragraph num="(2)"> <text>The collection of information to substantiate a diagnosis of an intellectual disability; and</text> </paragraph> <paragraph num="(3)"> <text>A meeting with the individual, proponent, or the licensee to discuss the terms and conditions of respite services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The proponent or licensee shall complete all forms required for respite services.</text> </paragraph> <paragraph num="D."> <text>The regional office shall render a written decision to the proponent or licensee within a week of the receipt of the completed application.</text> </paragraph> <paragraph num="E."> <text>On entering, the SRC shall arrange for a medical examination or nursing assessment as is appropriate to the individual.</text> </paragraph> <paragraph num="F."> <text>The SRC shall enter into a contract with the proponent or licensee which at a minimum contains:</text> <paragraph num="(1)"> <text>A statement that the acceptance of an individual for respite services is not considered an admission as defined in Health-General Article, §7-101(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A mutually agreed upon date on which the SRC may not provide respite services; and</text> </paragraph> <paragraph num="(3)"> <text>A designated time for the licensee or proponent to return the individual to the individual's community residence.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Leaving Respite Services."> <paragraph num="A."> <text>The SRC shall arrange for a medical examination or nursing assessment as is appropriate to the individual at the time the individual leaves respite services and shall document the findings.</text> </paragraph> <paragraph num="B."> <text>The SRC shall document information about the individual's response to respite services.</text> </paragraph> <paragraph num="C."> <text>The proponent or licensee shall return the individual to the individual's community residence at the time agreed to on the admission document.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Daily Programs."> <paragraph num="A."> <text>The SRC shall provide appropriate daily activities during the time the individual is in respite services.</text> </paragraph> <paragraph num="B."> <text>The SRC shall make every attempt to maintain the individual in the individual's vocational or day activity during the period of respite services and document the reasons if the individual is unable to attend.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Individual Records."> <text>The SRC shall maintain a complete record for each individual receiving respite services.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Funding."> <text>The Department's Division of Reimbursement shall determine the cost of respite services in the SRC pursuant to Health-General Article, §16-201, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 17, 1985 (12:12 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10, Developmental Services, repealed effective March 23, 1987 (14:6 Md. R. 716)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .19, Community Supported Living Arrangements (CSLA) Program, adopted as an emergency provision effective October 8, 1991 (18:22 Md. R. 2392); adopted permanently effective March 10, 1992 (19:3 Md. R. 304)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 14, 1996 (23:14 Md. R. 1006); amended permanently effective December 2, 1996 (23:24 Md. R. 1681)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Community Supported Living Arrangements (CSLA) Program, repealed and new chapter, Respite Services in the State Residential Center (SRC), adopted effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> </annotations> </chapter> <chapter num="12" heading="Eligibility for and Access to Community Services for Individuals with Developmental Disability"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>These regulations specify the individuals with developmental disability who are eligible for Developmental Disabilities Administration (DDA) funded services, the eligibility criteria which are set forth in Health-General Article, Title 7, Annotated Code of Maryland, and the process of eligibility determination.</text> </paragraph> <paragraph num="B."> <text>These regulations delineate the eligibility and access determination process involved in obtaining funding for services from the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="C."> <text>By outlining the eligibility and access process, these regulations comply with the requirements of Health-General Article, Title 7, Subtitle 4. They establish a uniformly applied Statewide policy that recognizes the needs of families and the comparative urgency of these needs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter is applicable to the eligibility and access process for individuals with developmental disability involved in seeking funding from the Developmental Disabilities Administration for services provided in community programs under the jurisdiction of the Administration. They do not apply to those similar processes which are related to services provided in State residential centers (SRCs) that are operated by the DDA.</text> </paragraph> <paragraph num="B."> <text>This chapter is not intended to address the criteria for access to specific services funded by the DDA. COMAR 10.22.13 addresses the admission of individuals with intellectual disabilities to State residential centers under the jurisdiction of the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="C."> <text>Individuals committed to the Department through the Maryland court system are not subject to the procedures set forth in these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Developmental Disabilities Administration (DDA).</text> </paragraph> <paragraph num="(2)"> <text>“Alternative living unit (ALU)” means a residence that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of developmental disability, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits not more than three individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per unit, per week.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Applicant” means the individual who files an application for services with the DDA.</text> </paragraph> <paragraph num="(4)"> <text>“Application for services” means the instrument:</text> <paragraph num="(a)"> <text>Used to make preliminary determination of eligibility for DDA services, the nature of the disability, the services required, and how these services are to be provided;</text> </paragraph> <paragraph num="(b)"> <text>Providing the basis for preliminary determination of service priority.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Appropriate evaluation” means the assessment of an individual using accepted professional standards to document the presence of a:</text> <paragraph num="(a)"> <text>Developmental disability as defined in Health-General Article, §7-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Disability that qualifies the individual for individual support services only as defined in Health-General Article, §7-403(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Caregiver” means the person who is primarily responsible for the ongoing care of the individual who is applying for services from the DDA. If the applicant is the caregiver, this term is applicable to the applicant.</text> </paragraph> <paragraph num="(6-1)"> <text>“Community Supported Living Arrangements Services (CSLA)” means one or more of the following services to assist an individual with developmental disability or an individual eligible for support services only in those nonvocational activities necessary to enable that individual to live in the individual's own home, apartment, family home, or rental unit, with not more than two other recipients of these services:</text> <paragraph num="(a)"> <text>Personal assistance;</text> </paragraph> <paragraph num="(b)"> <text>Supports that enhance the individual's opportunities for community participation and to exercise choice and control over the individual's own life;</text> </paragraph> <paragraph num="(c)"> <text>Community integration training services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity;</text> </paragraph> <paragraph num="(d)"> <text>24-hour emergency assistance;</text> </paragraph> <paragraph num="(e)"> <text>Assistive technology;</text> </paragraph> <paragraph num="(f)"> <text>Adaptive equipment;</text> </paragraph> <paragraph num="(g)"> <text>Case management services;</text> </paragraph> <paragraph num="(h)"> <text>Environmental modification;</text> </paragraph> <paragraph num="(i)"> <text>Respite care; and</text> </paragraph> <paragraph num="(j)"> <text>Other services as approved by the Secretary or the Secretary's designee.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Developmental Disabilities Administration access unit” (“DDA access unit” or “unit”) means the component which is under contract with the DDA to conduct the preliminary assessment of eligibility and priority for services based on the information provided on the application.</text> </paragraph> <paragraph num="(9)"> <text>“Developmental disability” means a severe, chronic disability of an individual that:</text> <paragraph num="(a)"> <text>Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments;</text> </paragraph> <paragraph num="(b)"> <text>Is manifested before the individual becomes 22 years old;</text> </paragraph> <paragraph num="(c)"> <text>Is likely to continue indefinitely;</text> </paragraph> <paragraph num="(d)"> <text>Results in an inability to live independently without external support or continuing and regular assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Director” means the Director of the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(11)"> <text>“Eligibility for support services only” means an individual shall have a severe chronic disability that is:</text> <paragraph num="(a)"> <text>Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and</text> </paragraph> <paragraph num="(b)"> <text>Likely to continue indefinitely.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Family support services” means a program designed to enable a family to provide for the needs of a child with developmental disability living in the home. Family support services include:</text> <paragraph num="(a)"> <text>Individual and family counseling;</text> </paragraph> <paragraph num="(b)"> <text>Personal care;</text> </paragraph> <paragraph num="(c)"> <text>Day care;</text> </paragraph> <paragraph num="(d)"> <text>Specialized equipment;</text> </paragraph> <paragraph num="(e)"> <text>Health services;</text> </paragraph> <paragraph num="(f)"> <text>Respite care;</text> </paragraph> <paragraph num="(g)"> <text>Housing adaptations;</text> </paragraph> <paragraph num="(h)"> <text>Transportation; and</text> </paragraph> <paragraph num="(i)"> <text>Other necessary services.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Grabau class” means those individuals:</text> <paragraph num="(a)"> <text>Who are confined in a SRC;</text> </paragraph> <paragraph num="(b)"> <text>Whose level of intellectual and personal skills is sufficient to allow them to function outside the SRC;</text> </paragraph> <paragraph num="(c)"> <text>Who have been characterized by the SRC as having maladaptive behavior or emotional disturbance of sufficient severity as to require their continued placement with the SRC; and</text> </paragraph> <paragraph num="(d)"> <text>Who have been confirmed as members of the class through an appropriate evaluation and staffing process designated by the DDA.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Home and Community Based Waiver (waiver)” means the document and any amendments to it submitted by the single State agency for Title XIX and approved by the Secretary of Health and Human Services, which authorizes the waiver of statutory requirements limiting coverage for home and community based services under the Medicaid State Plan.</text> </paragraph> <paragraph num="(15)"> <text>“Individual” means the person for whom an application for services has been filed with the DDA.</text> </paragraph> <paragraph num="(16)"> <text>“Individual family care home (IFC)” means a private single family residence licensed by the Department under COMAR 10.22.08 which:</text> <paragraph num="(a)"> <text>Under supervision, provides a home for individuals with developmental disability in a family atmosphere; and</text> </paragraph> <paragraph num="(b)"> <text>Provides habilitation services for one to three individuals who are not related to the caregiver.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Individual Support Services.</text> <paragraph num="(a)"> <text>“Individual support services” means an array of services that are designed to increase or maintain an individual's ability to live alone or in a family setting.</text> </paragraph> <paragraph num="(b)"> <text>“Individual support services” includes:</text> <paragraph num="(i)"> <text>In-home assistance with meals and personal care;</text> </paragraph> <paragraph num="(ii)"> <text>Counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Physical, occupational, or other therapies;</text> </paragraph> <paragraph num="(iv)"> <text>Architectural modification; and</text> </paragraph> <paragraph num="(v)"> <text>Any other services that the Administration considers appropriate to meet the individual's needs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Knott class” means individuals with intellectual disabilities who were or are deemed inappropriately placed within the Department’s operated behavioral health facilities.</text> </paragraph> <paragraph num="(19)"> <text>“Local review committee (LRC)” means the committee established by the regional director to review the service needs of eligible persons and make recommendations to the regional director.</text> </paragraph> <paragraph num="(20)"> <text>“Low intensity support services” means support services in accordance with COMAR 10.22.06. Services qualifying for this category are:</text> <paragraph num="(a)"> <text>Designed to be one-time only;</text> </paragraph> <paragraph num="(b)"> <text>Low cost with a cap of $3,000 per individual per year; or</text> </paragraph> <paragraph num="(c)"> <text>Approved by the regional office only if the cost of the services exceeds $3,000 or the services are needed beyond 1 calendar year.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Personal contact” means a discussion of circumstances with the applicant, caregiver, or other proponent, when one exists, with a representative of the DDA, who has knowledge in the disability or has access to the assistance of someone with knowledge in the disability, for the purpose of gathering information relevant to the determination of eligibility, service needs, and priorities.</text> </paragraph> <paragraph num="(22)"> <text>“Preliminary determination” means the outcome of the review of information supplied by or for the individual applying for DDA-funded services to produce an initial assessment of eligibility, service needs, and priorities.</text> </paragraph> <paragraph num="(23)"> <text>“Program” means a prescribed set of services and activities designed to achieve specific objectives related to the needs of the individuals served.</text> </paragraph> <paragraph num="(24)"> <text>“Proponent” means any person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA-licensed, operated, or funded program.</text> </paragraph> <paragraph num="(25)"> <text>“Provider” means a licensed agency which provides services through an appropriate agreement with the Department.</text> </paragraph> <paragraph num="(26)"> <text>“Regional director” means the director's designee who is charged with the management of the service delivery system in a specific geographic area of the State.</text> </paragraph> <paragraph num="(27)"> <text>“Resident” means an individual who:</text> <paragraph num="(a)"> <text>Demonstrates that that individual is living in the State voluntarily with an intent to remain on a permanent basis, including children with parents or guardians who reside out of the State;</text> </paragraph> <paragraph num="(b)"> <text>Resides out-of-State but whose parents or guardians are residents of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Is a migrant worker and, while in the State, needs medical care and is not receiving assistance from any other state or political jurisdiction.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(29)"> <text>“Secretary's designee” means the Director of the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(30)"> <text>“Service coordinator” means a professional who is assigned the responsibility for assisting the consumer in accessing the service delivery system more efficiently and effectively. This assistance is effected through planning, monitoring, and coordinating the medical, social, habilitative, and vocational services necessary to meet the identified needs of the consumer, as agreed upon and specified in the consumer's individualized service plan.</text> </paragraph> <paragraph num="(31)"> <text>“State residential center (SRC)” means a place that:</text> <paragraph num="(a)"> <text>Is owned and operated by the State;</text> </paragraph> <paragraph num="(b)"> <text>Provides residential services for individuals with intellectual disabilities and who, because of intellectual disabilities, require specialized living arrangements; and</text> </paragraph> <paragraph num="(c)"> <text>Admits nine or more individuals with intellectual disabilities.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Waiting list” means, for the purpose of this chapter, those individuals considered eligible for services and who have not received those services under the auspices of these regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Accessing the DDA Service Delivery System by Individuals with Developmental Disability."> <paragraph num="A."> <text>Referrals.</text> <paragraph num="(1)"> <text>An individual may be referred for service or services funded by the DDA by anyone who has legitimate interest in the welfare of the individual.</text> </paragraph> <paragraph num="(2)"> <text>Individuals shall make referrals to and obtain applications from the DDA or its designee.</text> </paragraph> <paragraph num="(3)"> <text>Individuals making referrals on behalf of individuals purported to have a developmental disability shall make them either separately or together with an application for services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application for Services.</text> <paragraph num="(1)"> <text>An individual applying for services funded wholly or in part by the DDA shall complete, or with assistance given by the DDA or its designee shall complete, an application for services.</text> </paragraph> <paragraph num="(2)"> <text>An application may be submitted by:</text> <paragraph num="(a)"> <text>The individual, if an adult; or</text> </paragraph> <paragraph num="(b)"> <text>A parent, guardian, caregiver, or other proponent, when one exists.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The individual submitting the application shall provide, at a minimum, sufficient information to make a preliminary determination of:</text> <paragraph num="(a)"> <text>The nature of the disability;</text> </paragraph> <paragraph num="(b)"> <text>Eligibility for DDA-funded services based on the characteristics of the individual;</text> </paragraph> <paragraph num="(c)"> <text>The individual's priority for DDA-funded services which shall take into account the:</text> <paragraph num="(i)"> <text>Urgency of need,</text> </paragraph> <paragraph num="(ii)"> <text>Strengths and needs of the applicant and caregiver,</text> </paragraph> <paragraph num="(iii)"> <text>Environment in which the applicant lives;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Service or services needed;</text> </paragraph> <paragraph num="(e)"> <text>Type of environment in which any needed services could be provided with the least restriction on the liberty of the individual; and</text> </paragraph> <paragraph num="(f)"> <text>Further evaluation, if any, the individual may require.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Processing the Application.</text> <paragraph num="(1)"> <text>The individual shall complete the application and send it to the DDA access unit.</text> </paragraph> <paragraph num="(2)"> <text>The unit shall send the applicant, caregiver, or other proponent, when one exists, a letter indicating receipt of the application and the results of the preliminary determination within 7 calendar days from the date the application is received.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility Criteria and Preliminary Determination Process."> <paragraph num="A."> <text>Eligibility Criteria. To be eligible for services funded by the DDA as an individual with developmental disability, that individual shall:</text> <paragraph num="(1)"> <text>Be a resident of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Have an evaluation that finds that a developmental disability is present.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preliminary Determination Process.</text> <paragraph num="(1)"> <text>The DDA access unit shall complete the preliminary determination and send the applicant, caregiver, or other proponent, when one exists, a letter containing the results within 7 calendar days of receipt of the application as indicated in Regulation .04C(2),of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The preliminary determination consists of a review of all information supplied by or for the individual to determine the presence of an apparent disability which meets the eligibility requirements.</text> </paragraph> <paragraph num="(3)"> <text>The DDA access unit shall send a letter to the applicant, caregiver, or other proponent, when one exists, which contains the following information:</text> <paragraph num="(a)"> <text>The DDA access unit has received the application;</text> </paragraph> <paragraph num="(b)"> <text>The individual appears to have a developmental disability, or does not appear to have a developmental disability, but may be eligible for individual support services in accordance with Health-General Article, §7-403(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>The applicant, caregiver, or other proponent, when one exists, shall receive a personal contact in accordance with Regulation .03B(21) of this chapter, or the individual is not eligible for services funded by the DDA and no further action shall be taken by the DDA, absent an appeal of this determination;</text> </paragraph> <paragraph num="(d)"> <text>The individual may be eligible for services from the Behavioral Health Administration; and</text> </paragraph> <paragraph num="(e)"> <text>The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Eligibility Determination Process — Personal Contact and Determination of Service Needs."> <paragraph num="A."> <text>Determination of Service Needs.</text> <paragraph num="(1)"> <text>When a personal contact is made by a representative of the DDA, in accordance with Regulation .05B(3)(c), of this chapter, the representative shall:</text> <paragraph num="(a)"> <text>Establish if the individual has a developmental disability;</text> </paragraph> <paragraph num="(b)"> <text>Establish the nature of the disability;</text> </paragraph> <paragraph num="(c)"> <text>Collect sufficient information, including any existing evaluations, to make a recommendation concerning assignment to a services priority category, taking into account the strengths and needs of the family, caregiver, and the individual;</text> </paragraph> <paragraph num="(d)"> <text>Describe the nature of the services that the individual may require through:</text> <paragraph num="(i)"> <text>Discussion with the applicant, caregiver, or other proponent, when one exists, and</text> </paragraph> <paragraph num="(ii)"> <text>Observation of the interaction between the applicant, caregiver, or other proponent, when one exists;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Describe the type of environment that the individual may require through:</text> <paragraph num="(i)"> <text>Discussion with the applicant, caregiver, or other proponent, when one exists, and</text> </paragraph> <paragraph num="(ii)"> <text>Observation of the interaction between the applicant, caregiver, or other proponent, when one exists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A face-to-face personal contact shall be conducted for individuals living in the community. For individuals living in chronic hospitals, rehabilitation facilities, residential schools, or for a transitioning youth whose only service need is a day program, a personal contact may consist of interviews with staff or individuals by phone or in person. Knott class individuals shall receive a personal contact. Individuals with the sole diagnosis of mental illness or otherwise not eligible for DDA-funded services may not receive a personal contact.</text> </paragraph> <paragraph num="(3)"> <text>A representative of the DDA shall give written results of the personal contact to the appropriate regional director with a recommendation regarding eligibility, service needs, and priorities.</text> </paragraph> <paragraph num="(4)"> <text>If the regional director agrees that the individual is eligible for services, the regional director shall recommend to the Director that the individual be assigned to one or more of six service priority categories described in Regulation .07B of this chapter, for each service as appropriate.</text> </paragraph> <paragraph num="(5)"> <text>The Director shall review the recommendation of the regional director concerning eligibility, service needs, and priorities.</text> </paragraph> <paragraph num="(6)"> <text>The Director shall send a letter to the applicant notifying the individual of the decision regarding the applicant's:</text> <paragraph num="(a)"> <text>Eligibility;</text> </paragraph> <paragraph num="(b)"> <text>Service needs;</text> </paragraph> <paragraph num="(c)"> <text>Priorities; and</text> </paragraph> <paragraph num="(d)"> <text>Right to an informal hearing in accordance with COMAR 10.22.16.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility and Access Time Frame.</text> <paragraph num="(1)"> <text>The entire eligibility and access process may not exceed 60 days except under the following conditions:</text> <paragraph num="(a)"> <text>Scheduled appointments are cancelled by the applicant, caregiver, or other proponent, when one exists, and new appointments cannot be scheduled in a timely manner; or</text> </paragraph> <paragraph num="(b)"> <text>Requested information necessary to make recommendations regarding eligibility, service needs, and priorities has not been received from the applicant, caregiver, or other proponent, when one exists.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The regional director shall review the applicant's requests for extensions of the eligibility and access process. Requests may be approved if the above conditions have been corrected or if definite arrangements have been made to correct the above conditions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Eligibility Determination Process — Determination of Service Priority Category and Description of Categories."> <paragraph num="A."> <text>Determination of Service Priority Category.</text> <paragraph num="(1)"> <text>The regional director shall base the recommendation regarding service priority on the determination that the individual meets the criteria for one or more of the following categories, which are listed in the order of priority in which applicants shall receive services:</text> <paragraph num="(a)"> <text>Category I — Crisis Resolution;</text> </paragraph> <paragraph num="(b)"> <text>Category II — Crisis Prevention; and</text> </paragraph> <paragraph num="(c)"> <text>Category III — Current Request.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individuals shall be served according to their priority ranking as follows:</text> <paragraph num="(a)"> <text>Individuals in Category I are to be served before those in Category II; and</text> </paragraph> <paragraph num="(b)"> <text>Individuals in Category II are to be served before those in Category III.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Service delivery is dependent upon levels of funding allocated for the fiscal year for the following discrete categories:</text> <paragraph num="(a)"> <text>Category IV — Transitioning Youth;</text> </paragraph> <paragraph num="(b)"> <text>Category V — Knott Class Member;</text> </paragraph> <paragraph num="(c)"> <text>Category VI — Inappropriate Institutionalization; and</text> </paragraph> <paragraph num="(d)"> <text>Category VII — Innovation or Demonstration Projects.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Individuals may be in more than one priority category at the same time. For example, an individual in the transitioning youth priority category for a day program may also be in the crisis prevention priority category for a residential program if the individual is graduating or leaving a secondary school program and has no place to live after that program ends.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Description of Categories.</text> <paragraph num="(1)"> <text>Category I — Crisis Resolution.</text> <paragraph num="(a)"> <text>To qualify for this category, the applicant shall meet one or more of the following criteria. The applicant shall be:</text> <paragraph num="(i)"> <text>Homeless or living in temporary housing with clear time-limited ability to continue to live in this setting with no viable non-DDA-funded alternative;</text> </paragraph> <paragraph num="(ii)"> <text>At serious risk of physical harm in the current environment;</text> </paragraph> <paragraph num="(iii)"> <text>At serious risk of causing physical harm to others in the current environment;</text> </paragraph> <paragraph num="(iv)"> <text>In danger of losing DDA-funded residential services because of a lack of current day services;</text> </paragraph> <paragraph num="(v)"> <text>One who has lost DDA-funded day services; or</text> </paragraph> <paragraph num="(vi)"> <text>Living with a caregiver who is unable to provide adequate care due to the caregiver's impaired health, which may place the applicant at risk of serious physical harm.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>To qualify for Category I under §B(1)(a)(ii), of this regulation, evidence such as the following shall be necessary. The applicant:</text> <paragraph num="(i)"> <text>Has recently received severe injuries due to the behavior of others in the home or community;</text> </paragraph> <paragraph num="(ii)"> <text>Has recently been the victim of sexual abuse;</text> </paragraph> <paragraph num="(iii)"> <text>Has been neglected to the extent that the individual is at serious risk of sustaining injuries which are life threatening or which substantially impair functioning;</text> </paragraph> <paragraph num="(iv)"> <text>Engages in self-injurious behavior which puts the individual at serious risk of sustaining injuries which are life threatening or which substantially impair functioning; or</text> </paragraph> <paragraph num="(v)"> <text>Is at serious risk of sustaining injuries which are life threatening or which substantially impair functioning due to the physical surroundings.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the applicant qualifies for Category I under §B(1)(a)(v), of this regulation, the individual shall qualify for day services only.</text> </paragraph> <paragraph num="(d)"> <text>If the applicant is living in a situation where the applicant is the caregiver, §B(1)(a)(vi), of this regulation, shall apply to the applicant.</text> </paragraph> <paragraph num="(e)"> <text>Individuals who qualify for services under this category shall, at a minimum, remain in this category until they have been provided with those services required to resolve the situation.</text> </paragraph> <paragraph num="(f)"> <text>Individuals become eligible to receive services as the need occurs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Category II — Crisis Prevention.</text> <paragraph num="(a)"> <text>To qualify for this priority category, the applicant:</text> <paragraph num="(i)"> <text>Shall have been determined by the DDA to have an urgent need for services;</text> </paragraph> <paragraph num="(ii)"> <text>May not qualify for services based on the criteria for Category I; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall be at substantial risk for meeting one or more of the criteria in §B(1)(a) of this regulation, within 1 year, or have a caregiver who is 65 years old or more.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Individuals who qualify for services under this category shall, at a minimum, remain in this category until they have been provided with those services required to resolve the situation.</text> </paragraph> <paragraph num="(c)"> <text>Individuals become eligible to receive services from the date of approval of priority status, except when eligibility is determined by the age of the caregiver. In this case, priority is determined by the caregiver's date of birth so that individuals with caregivers born at an earlier date have priority over individuals with caregivers born at a later date.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Category III — Current Request.</text> <paragraph num="(a)"> <text>To qualify for this priority category, the applicant shall indicate at least a current need for services.</text> </paragraph> <paragraph num="(b)"> <text>Prioritization of Services.</text> <paragraph num="(i)"> <text>Applicants shall be prioritized for services based on the number of fiscal years they have been on the waiting list, except as provided for in §B(3)(b)(iv) of this regulation.</text> </paragraph> <paragraph num="(ii)"> <text>Applicants on the waiting list for the longest period of time shall receive services before those who have been on the list for fewer years, except as provided for in §B(3)(b)(iv) of this regulation.</text> </paragraph> <paragraph num="(iii)"> <text>Applicants whose applications are received by the DDA access unit within a given fiscal year shall be ranked by the fiscal year of application, and the month and day of birth. Those applicants born at the beginning of the fiscal year have priority over those born later in the year.</text> </paragraph> <paragraph num="(iv)"> <text>For day programs only, the period of time that shall be counted toward prioritizing an individual shall begin with the year of departure from school or the year of application, whichever is later.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Category IV — Transitioning Youth.</text> <paragraph num="(a)"> <text>To qualify for funding for services in this priority category the applicant shall be eligible:</text> <paragraph num="(i)"> <text>For DDA-funded services in this category from the individual's 21st to the individual's 22nd birthday. If the date of graduation is after the individual's 21st birthday, the individual shall continue to be eligible for 1 year after the date of graduation.</text> </paragraph> <paragraph num="(ii)"> <text>To receive day services only.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Individuals in this priority category shall also be in one or more of the other priority categories.</text> </paragraph> <paragraph num="(c)"> <text>Individuals become eligible to receive services from the date of approval of priority status.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Category V — Knott Class.</text> <paragraph num="(a)"> <text>To qualify for this priority category, the applicant shall have:</text> <paragraph num="(i)"> <text>An intellectual disability; and</text> </paragraph> <paragraph num="(ii)"> <text>Been determined inappropriately retained in a Department operated behavioral health facility as set forth in Knott vs. Hughes Civil Action No. Y-80-2832 (Fed. Dist. Ct. Md).</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Individuals become eligible to receive services based on the best clinical judgment of the professionals involved based on availability of allocated resources.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Category VI — Inappropriate Institutionalization.</text> <paragraph num="(a)"> <text>To qualify for this priority category, the applicant shall be a:</text> <paragraph num="(i)"> <text>Resident in a nursing facility and not meet the criteria for admission or retention for that facility;</text> </paragraph> <paragraph num="(ii)"> <text>Resident of an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) and not meet the criteria for admission or retention for that facility as determined by the hearing examiner;</text> </paragraph> <paragraph num="(iii)"> <text>Resident in a chronic hospital who does not meet the criteria for admission or retention for that facility;</text> </paragraph> <paragraph num="(iv)"> <text>Resident in a behavioral health facility operated by the Department who has a developmental disability but is not an individual with an intellectual disability and who does not meet the criteria for admission or retention in a State psychiatric hospital and whose primary need is not for a mental health service.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual in this priority category shall also be in another priority category.</text> </paragraph> <paragraph num="(c)"> <text>Funding may be allocated for one or more of the above groups in §B(6)(a)(i)—(iv) of this regulation.</text> </paragraph> <paragraph num="(d)"> <text>Individuals become eligible to receive services based on the best clinical judgment of the professionals involved based on availability of allocated resources.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Category VII — Innovation or Demonstration Projects.</text> <paragraph num="(a)"> <text>To identify those individuals for whom this priority category is appropriate, the Administration, after consultation with interested parties, shall publish a request for proposal (RFP) for innovation or demonstration projects.</text> </paragraph> <paragraph num="(b)"> <text>To qualify for this priority category, an individual shall be identified in a proposal submitted to the Administration which is considered appropriate for funding by the Administration.</text> </paragraph> <paragraph num="(c)"> <text>An individual served in this priority category may continue to receive services, to the extent that funds are allocated, after the termination of the innovation or demonstration period.</text> </paragraph> <paragraph num="(d)"> <text>An individual in this priority category may also be in another priority category.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Eligible applicants may receive family support services and low intensity support services on a first-come, first-served basis, regardless of service priority determination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Letter of Final Determination."> <paragraph num="A."> <text>Within 60 days of the receipt of the application, the final letter of determination indicating eligibility, priority, and service needs shall be sent to the applicant, caregiver, or other proponent, when one exists.</text> </paragraph> <paragraph num="B."> <text>The letter shall contain the following information:</text> <paragraph num="(1)"> <text>A statement that the individual has a developmental disability or the individual does not have a developmental disability, but may be eligible for individual support services in accordance with Health-General Article, §7-403(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The nature of the services the individual may require;</text> </paragraph> <paragraph num="(3)"> <text>The type of environment in which any needed services could be provided;</text> </paragraph> <paragraph num="(4)"> <text>The types of evaluations, if any, the individual requires;</text> </paragraph> <paragraph num="(5)"> <text>That determinations of priority status may be subject to modification if the applicant's or caregiver's circumstances change;</text> </paragraph> <paragraph num="(6)"> <text>The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16; and</text> </paragraph> <paragraph num="(7)"> <text>That the individual shall apply for Medical Assistance or other alternative funding before the initiation of services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Local Review Committee."> <paragraph num="A."> <text>The regional director shall establish one or more local review committees.</text> </paragraph> <paragraph num="B."> <text>The function of the LRC is to review the service needs of eligible individuals and make recommendations regarding service needs to the regional director. The LRC shall be appointed by the regional director from among the following:</text> <paragraph num="(1)"> <text>County government, including local health departments;</text> </paragraph> <paragraph num="(2)"> <text>DDA;</text> </paragraph> <paragraph num="(3)"> <text>Advocacy or developmental disability provider agencies; and</text> </paragraph> <paragraph num="(4)"> <text>Parents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The regional director or designee shall serve as chairperson of the LRC.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Confirmation of Eligibility for Service Provision."> <paragraph num="A."> <text>Confirmation of eligibility, which is established before selection of the individual to receive services, is based on an evaluation in accordance with Health-General Article, §7-404, Annotated Code of Maryland. The exception shall be an emergency situation when a crisis needs to be immediately resolved as specified in Regulation .11B.</text> </paragraph> <paragraph num="B."> <text>The regional director shall be responsible for assuring that the evaluation required by Health-General Article, §7-404, Annotated Code of Maryland, has been completed before final determination of eligibility. The individual's evaluation shall confirm the following:</text> <paragraph num="(1)"> <text>That the individual has a developmental disability as indicated by the preliminary determination;</text> </paragraph> <paragraph num="(2)"> <text>The nature of the disability;</text> </paragraph> <paragraph num="(3)"> <text>The nature of the services that the individual may require;</text> </paragraph> <paragraph num="(4)"> <text>The type of environment in which any needed services could be provided with the least restriction on the liberty of the individual; and</text> </paragraph> <paragraph num="(5)"> <text>The extent and timing of the services to be provided to the individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the regional director concludes that the evidence supports eligibility for service provision, a recommendation may be made to the Director that funding for services for the individual be approved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Initiation of Services."> <paragraph num="A."> <text>Initiation of service delivery to an eligible individual seeking DDA-funded services shall be dependent upon:</text> <paragraph num="(1)"> <text>Assigned service priority, except for family support services and low intensity support services which are provided on a first-come, first-served basis;</text> </paragraph> <paragraph num="(2)"> <text>Availability and allocation of funds provided to the DDA;</text> </paragraph> <paragraph num="(3)"> <text>Availability of an appropriate community vacancy; and</text> </paragraph> <paragraph num="(4)"> <text>The individual's completing an application for Medical Assistance or other alternative funding.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Situations.</text> <paragraph num="(1)"> <text>If an emergency situation arises and immediate services are needed to resolve a crisis, the regional director may telephone the Director or the Director's designee to authorize the initiation of services for a maximum of 15 calendar days, provided that an:</text> <paragraph num="(a)"> <text>Evaluation pursuant to Regulation .10B(2) is performed to confirm eligibility within 10 calendar days of the initiation of services. If the individual cannot afford evaluation services, the State shall arrange for them.</text> </paragraph> <paragraph num="(b)"> <text>Application for services is processed pursuant to Regulation .04C and approved by the Director pursuant to Regulation .10.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Director or the Director's designee cannot be reached, the regional director may authorize services provided that the approval is obtained on the next working day.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Ninety days after the receipt of services, the service needs and priority status of an individual shall be reviewed by the regional director or the regional director's designee, and adjusted if indicated. If the service meets the needs of the individual, the individual's name shall be removed from the waiting list for that service.</text> </paragraph> <paragraph num="D."> <text>Any time after the receipt of services, an eligible individual may:</text> <paragraph num="(1)"> <text>Apply for or request a change in intensity of services or support, or apply for additional services;</text> </paragraph> <paragraph num="(2)"> <text>Request a less intensive form of that service, and may receive the less intensive service if it is available.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Individuals assigned to Category I who enter a State residential center because needed community services are not available or will not be available within a reasonable time, shall retain their eligibility and priority status for community services for 12 months after the date they enter the SRC.</text> </paragraph> <paragraph num="F."> <text>Except in an emergency situation or a case approved by the Director because of extenuating circumstances, DDA may not fund services for individuals with State-only dollars unless the individual has been denied:</text> <paragraph num="(1)"> <text>Medical Assistance including waiver services; and</text> </paragraph> <paragraph num="(2)"> <text>Related alternative funding.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Admission to and Discharge from DDA Community-Funded Services."> <paragraph num="A."> <text>Exception. This regulation does not apply to family services or low intensity support services.</text> </paragraph> <paragraph num="B."> <text>General Requirements for Assigning Vacancies or Providing Support Services.</text> <paragraph num="(1)"> <text>Only those individuals seeking DDA-funded services and who have been deemed eligible by the DDA in accordance with Regulations .05—.10 of this chapter may be served by community service providers in DDA-funded vacancies or with DDA-funded support services.</text> </paragraph> <paragraph num="(2)"> <text>Each provider shall report all DDA-funded vacancies to the appropriate regional office in accordance with a DDA-approved procedure, as soon as the potential vacancy is known to the provider.</text> </paragraph> <paragraph num="(3)"> <text>The DDA shall authorize all admissions to or discharges from DDA-funded services in advance of these actions by providers.</text> </paragraph> <paragraph num="(4)"> <text>In addition to a final determination of eligibility before authorizing the admission of an individual to a funded vacancy, the DDA shall also determine that the:</text> <paragraph num="(a)"> <text>Individual is in need of the type of service to be provided;</text> </paragraph> <paragraph num="(b)"> <text>Service is appropriate and is to be provided with the least restriction on the liberty of the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Individual wishes to be served by the particular provider or, at a minimum, agrees to accept the service from that provider.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the individual does not qualify under Category I, the regional director shall determine that there is no one in that category who would be more appropriate for the vacancy or service.</text> </paragraph> <paragraph num="(6)"> <text>If an appropriate vacancy exists, but the provider refuses to serve an individual whom the DDA has identified as qualified to receive services, the regional office may not authorize the provider to fill the vacancy. The funding for the vacancy may be transferred to another provider that offers an appropriate service and is willing to serve the individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific Criteria for Assigning Community Program Vacancies or Providing Support Services.</text> <paragraph num="(1)"> <text>The DDA shall develop a Statewide list of eligible individuals to fill a vacancy in a community program. The list should be organized according to priority ranking and according to the criteria for those categories. From this list:</text> <paragraph num="(a)"> <text>The first eligible individual in the county where that vacancy exists who is appropriate for the service may be served;</text> </paragraph> <paragraph num="(b)"> <text>Any other eligible individual whose name appears on the list before that of the individual described in §C(1)(a) of this regulation, may be served if appropriate for the service; and</text> </paragraph> <paragraph num="(c)"> <text>The regional director shall define appropriateness for the service and shall consider the compatibility of residents for multi-person residences.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individuals eligible under Category I, Crisis Resolution, as specified in Regulation .07B, may be served on a priority basis in an appropriate community program vacancy created by the movement of any client except a:</text> <paragraph num="(a)"> <text>Client receiving services under the auspices of the Title XIX 1915(c) waiver;</text> </paragraph> <paragraph num="(b)"> <text>Knott class member;</text> </paragraph> <paragraph num="(c)"> <text>Grabau class member; or</text> </paragraph> <paragraph num="(d)"> <text>Former SRC client who has been returned to the SRC.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Vacancies created by the movement of a waiver-eligible individual shall be filled by another client who is eligible for services under the waiver criteria as specified in COMAR 10.09.26.</text> </paragraph> <paragraph num="(4)"> <text>Vacancies created by the movement of a Knott class member shall be filled in the following manner:</text> <paragraph num="(a)"> <text>By another member of the Knott class;</text> </paragraph> <paragraph num="(b)"> <text>If there is no Knott class member in need of that vacancy at the time that the vacancy occurs, the vacancy is to be filled by:</text> <paragraph num="(i)"> <text>A member of the Grabau class,</text> </paragraph> <paragraph num="(ii)"> <text>An individual eligible under Category I, Crisis Resolution, or</text> </paragraph> <paragraph num="(iii)"> <text>An individual eligible under Category II, Crisis Prevention.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the vacancy is filled by anyone other than a Knott class member, the Director may use funds provided for community expansion to create an equivalent placement for a Knott class member.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Vacancies created by the movement of a nonwaiver Grabau class member shall be filled in the following manner:</text> <paragraph num="(a)"> <text>By another member of the Grabau class;</text> </paragraph> <paragraph num="(b)"> <text>If there is no Grabau class member in need of that vacancy at the time that the vacancy occurs, the vacancy is to be filled by:</text> <paragraph num="(i)"> <text>A member of the Knott class,</text> </paragraph> <paragraph num="(ii)"> <text>An individual eligible under Category I, Crisis Resolution, or</text> </paragraph> <paragraph num="(iii)"> <text>An individual eligible under Category II, Crisis Prevention;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the vacancy is filled by anyone other than a Grabau class member, the Director may use funds provided for community expansion to create an equivalent placement for a Grabau class member.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Vacancies created by the movement of an institutional client out of a community day program shall be filled in the following manner:</text> <paragraph num="(a)"> <text>By another institutional client;</text> </paragraph> <paragraph num="(b)"> <text>If there is no appropriate institutional client at the time the vacancy occurs, the vacancy may be filled by an individual under Category I, II, or III in that order;</text> </paragraph> <paragraph num="(c)"> <text>The regional director shall define “appropriate client”, taking into consideration the behavior of the client and the day program available; and</text> </paragraph> <paragraph num="(d)"> <text>If the vacancy is filled by anyone other than an institutional client, the Director may use funds provided for community expansion to create an equivalent placement for an institutional client.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>When filling vacancies for a multi-person community residence, such as an ALU or an IFC home, all available vacancies shall be filled through the procedures set forth in §B(1) of this regulation.</text> </paragraph> <paragraph num="(8)"> <text>Vacancies for community expansion shall be filled in the order in which the individual's name appears on the Statewide eligibility list. When selecting individuals for multi-person community residential programs, the second and all subsequent individuals shall be selected as set forth in §C(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Transfers to and from Community Program Vacancies.</text> <paragraph num="(1)"> <text>Individuals currently enrolled in one provider's program may request a transfer to another provider by submitting a request in writing to the service coordinator or to the regional office.</text> </paragraph> <paragraph num="(2)"> <text>The service coordinator shall review the request and make a recommendation to the regional director.</text> </paragraph> <paragraph num="(3)"> <text>The regional director may authorize the request if an appropriate vacancy exists.</text> </paragraph> <paragraph num="(4)"> <text>If an appropriate vacancy does not exist, the individual shall be placed on the region's waiting list for transfers based on the date of approval of the transfer. The individual on the transfer list shall have priority over those individuals in the Current Request priority category, but may not have priority over those individuals in the Crisis Resolution or Crisis Prevention priority categories.</text> </paragraph> <paragraph num="(5)"> <text>Individuals requesting transfers outside the region shall have their requests forwarded to the appropriate regional office.</text> </paragraph> <paragraph num="(6)"> <text>The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Eligibility for Other Services."> <paragraph num="A."> <text>An individual's eligibility for services provided by any other public or private agency may not be affected by the individual's eligibility for services pursuant to these regulations.</text> </paragraph> <paragraph num="B."> <text>If an individual who is eligible for services funded by the DDA may also be eligible for services provided by another agency, the DDA or its agent shall refer the individual to that agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Reporting Requirements."> <text>The DDA access unit shall issue an annual report on the characteristics of applicants for DDA-funded services which shall include:</text> <paragraph num="A."> <text>Information on the total number of individuals waiting for services by service request and priority category;</text> </paragraph> <paragraph num="B."> <text>The number of individuals who have been added or removed by service request and priority category; and</text> </paragraph> <paragraph num="C."> <text>Other pertinent information which would assist in planning for future services or evaluating current performance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Administrative and Judicial Review."> <paragraph num="A."> <text>Pursuant to COMAR 10.22.16:</text> <paragraph num="(1)"> <text>On any action or inaction of the Secretary pursuant to Regulations .01—.14 of this chapter, an applicant for or recipient of DDA-funded services may request:</text> <paragraph num="(a)"> <text>An informal hearing before the Secretary's designee, and</text> </paragraph> <paragraph num="(b)"> <text>The Secretary to review the decision of the informal hearing if that decision is not acceptable.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Informal hearings under §A(1)(a) of this chapter shall be conducted in accordance with the Developmental Disabilities Law, Health-General Article, Title 7, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>After a request for a review is made, the Secretary shall conduct the review in accordance with State Government Article, §§10-201—10-217, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person aggrieved by a final decision of the Secretary in a contested case as defined in State Government Article, §10-201, may take an appeal as allowed in State Government Article, §§10-215 and 10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Providers filing appeals in connection with these regulations shall do so in accordance with State Government Article, §§10-201—10-217 and 10-401—10-405, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-401, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 4, 1991 (18:4 Md. R. 447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B and .12A amended as an emergency provision effective June 14, 1996 (23:14 Md. R. 1006); amended permanently effective December 2, 1996 (23:24 Md. R. 1681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective September 28, 1992 (19:19 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.22.18 recodified to COMAR 10.22.12 effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 26, 2007 (34:6 Md. R. 627); November 25, 2013 (40:23 Md. R. 1934), March 30, 2026 (53:6 Md. R. 291)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 30, 2026 (53:6 Md. R. 291)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective November 25, 2013 (40:23 Md. R. 1934); March 30, 2026 (53:6 Md. R. 291)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11F adopted as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); adopted permanently effective December 22, 2003 (30:25 Md. R. 1845)</annotation> </annotations> </chapter> <chapter num="13" heading="Admission of Individuals to State Residential Facilities Under the Jurisdiction of the Developmental Disabilities Administration"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations shall apply to each individual who has been admitted to any State residential center under the jurisdiction of the Developmental Disabilities Administration of the Maryland Department of Health.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Admission.</text> <paragraph num="(a)"> <text>“Admission” means the process by which an individual with an intellectual disability is accepted as a resident in a State residential center.</text> </paragraph> <paragraph num="(b)"> <text>“Admission” includes the physical act of the individual entering the facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Hearing” means the administrative proceedings which are conducted to determine whether the conclusions leading to an admission decision were properly drawn.</text> </paragraph> <paragraph num="(3)"> <text>“Hearing examiner” means any impartial officer designated by the Secretary of Health to conduct hearings and make administrative decisions in accordance with these regulations.</text> </paragraph> <paragraph num="(4)"> <text>“Proponent” means any person who has a legitimate interest in the welfare of an individual who is being served in a program licensed, operated, or funded by the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(5)"> <text>“Reasonable time” means a period after a hearing in which an appropriate program or service shall be made available to an individual in order to avoid admission to a State residential center. This period of time may not exceed 90 days unless there is a program or service which is identified as available to the individual and which will accept the individual for services to begin on a fixed date.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Hearing Procedures."> <paragraph num="A."> <text>The hearing shall be conducted within 21 days after the admission of an individual to a State residential center.</text> </paragraph> <paragraph num="B."> <text>Written notice of the admission of an individual and of the date, time, and place of the individual's hearing shall be given:</text> <paragraph num="(1)"> <text>On admission to the individual; or</text> </paragraph> <paragraph num="(2)"> <text>As soon as possible, but not later than 5 days after the admission to legal counsel for the individual and to the proponent of the admission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice also shall state the:</text> <paragraph num="(1)"> <text>Name of each proponent of the admission;</text> </paragraph> <paragraph num="(2)"> <text>Rights of the individual who has been admitted to:</text> <paragraph num="(a)"> <text>Consult with and be represented by a lawyer, and</text> </paragraph> <paragraph num="(b)"> <text>Call witnesses and offer evidence at the hearing on admission;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Availability of the services of the Legal Aid Bureau, lawyer referral services, and other agencies that exist for the referral of individuals who need legal counsel;</text> </paragraph> <paragraph num="(4)"> <text>Right of individuals with developmental disabilities, pursuant to Health-General Article, Title 7, Subtitle 10, and §7-1102, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Rights of the individual to release, pursuant to Health-General Article, §§7-506, 7-507, and 7-508, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The parties to the hearing shall be the proponent and the individual.</text> </paragraph> <paragraph num="E."> <text>Each hearing which is held pursuant to Health-General Article, §7-503, shall be held in an appropriate room within the facility in which the individual is a resident, or in such other place as is deemed appropriate by the hearing examiner.</text> </paragraph> <paragraph num="F."> <text>The individual shall have the right to appear dressed in his or her own clothing, at the hearing, if he or she so desires.</text> </paragraph> <paragraph num="G."> <text>The records of the facility which address any aspect of the individual for whom the hearing shall be held shall, upon request, be made available to counsel for that person.</text> </paragraph> <paragraph num="H."> <text>A mechanical recording of the hearing shall be made, but a transcription need not be made unless an appropriate appeal is taken.</text> </paragraph> <paragraph num="I."> <text>Rules of Evidence--Notice.</text> <paragraph num="(1)"> <text>The hearing examiner:</text> <paragraph num="(a)"> <text>May admit and give probative effect to evidence which possesses probative value commonly accepted by reasonable and prudent persons in the conduct of their affairs;</text> </paragraph> <paragraph num="(b)"> <text>Shall give effect to the rules of privilege recognized by law;</text> </paragraph> <paragraph num="(c)"> <text>May exclude incompetent, irrelevant, immaterial, and unduly repetitious evidence.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All evidence, including records and documents in the possession of the agency, of which it desires to avail itself, shall be offered and made a part of the record in the case, and other factual information or evidence may not be considered in the determination of the case. Documentary evidence may be received in the form of copies or excerpts, or by incorporation by reference.</text> </paragraph> <paragraph num="(3)"> <text>Each party shall have the right:</text> <paragraph num="(a)"> <text>Of cross-examination of witnesses who testify; and</text> </paragraph> <paragraph num="(b)"> <text>To submit rebuttal evidence.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The hearing examiner may take notice of judicially cognizable facts and, in addition, may take notice of general, technical, or scientific facts within the hearing examiner's specialized knowledge. Parties shall be notified either before or during the hearing, or by reference in preliminary reports or otherwise, of the material so noticed, and the parties shall be afforded an opportunity to contest the facts so noticed. The hearing examiner may use experience, technical competence, and specialized knowledge in the evaluation of the evidence presented.</text> </paragraph> <paragraph num="(5)"> <text>The hearing examiner as designee of the Secretary of Health, upon request and good cause shown, shall issue appropriate process to compel the attendance of witnesses and the production of documents or other tangible evidence. This power is granted pursuant to Health-General Article, §2-104(k), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>Telephoned Testimony. The hearing examiner, on the motion of the hearing examiner or upon request of a party to the hearing, may allow the testimony of any party or nonparty witness to be taken by telephone. The hearing examiner shall notify all parties in advance of the hearing that the testimony of a witness will be taken by telephone. When testimony is taken by telephone, the hearing examiner shall employ appropriate techniques to ensure that the testimony is fully audible to all parties present at the hearing and the testimony is made a part of the hearing record. The party shall be allowed to fully cross-examine any witness whose testimony is taken using this procedure.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Admission Requirements.</text> <paragraph num="(1)"> <text>At the hearing, in order to certify the admission of the individual, it shall be affirmatively shown by clear and convincing evidence that the conclusions leading to the decision to admit the individual were supported by the following findings:</text> <paragraph num="(a)"> <text>That the individual whose admission is sought has an intellectual disability;</text> </paragraph> <paragraph num="(b)"> <text>That the individual needs residential services for the provision of adequate habilitation; and</text> </paragraph> <paragraph num="(c)"> <text>That there is no less restrictive setting in which the needed services can be provided that is available to the individual, or will be available to the individual within a reasonable time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the hearing examiner finds from the admissible evidence that the conclusions leading to the admission decision are invalid, the hearing examiner shall so certify and the individual shall be released from the State residential center.</text> </paragraph> <paragraph num="(3)"> <text>If the hearing examiner finds from the evidence presented that all of the admission requirements have been proved, the hearing examiner shall so certify and the individual's admission shall be considered approved.</text> </paragraph> <paragraph num="(4)"> <text>If the hearing examiner certifies the admission of an individual to a State residential center, the hearing examiner shall, at the conclusion of the hearing, write on the certification form any additional services of habilitation that are not included in the evaluation report, but that the hearing officer finds from the evidence are needed by the individual.</text> </paragraph> <paragraph num="(5)"> <text>If the hearing examiner certifies the admission of an individual to a State residential center, at the conclusion of the hearing, the examiner shall advise the individual and the legal counsel of the individual's right to seek judicial release from the State Residential Center under Health-General Article, §7-507, Annotated Code of Maryland, and of his right to file a petition for habeas corpus under Health-General Article, §7-506, Annotated Code of Maryland. The hearing examiner shall also advise individual and legal counsel of the individual's right under the appeal provision of State Government Article, §§10-215 and 10-216, Annotated Code of Maryland. The individual's rights shall be communicated in a form of language that the individual understands.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Hearing Examiners' Powers. In addition to other powers and authority granted by law, the hearing examiner shall:</text> <paragraph num="(1)"> <text>Administer oaths and affirmation;</text> </paragraph> <paragraph num="(2)"> <text>Issue summonses for the attendance of witnesses at the hearings and subpoenas requiring the production of physical evidence;</text> </paragraph> <paragraph num="(3)"> <text>Rule upon offers of proof by the parties;</text> </paragraph> <paragraph num="(4)"> <text>Consider and rule upon all procedural and other motions appropriate to the proceedings;</text> </paragraph> <paragraph num="(5)"> <text>Examine witnesses;</text> </paragraph> <paragraph num="(6)"> <text>Maintain order and limit unduly repetitious or irrelevant testimony or argument.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 1, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 amended effective February 11, 1985 (12:3 Md. R. 245)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 repealed effective September 5, 1988 (15:18 Md. R. 2151)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 adopted effective September 5, 1988 (15:18 Md. R. 2151)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.22.01 recodified to COMAR 10.22.13 effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> </annotations> </chapter> <chapter num="14" heading="Low Intensity Support Services (LISS) Program"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to establish a Low Intensity Support Services (LISS) Program in the Developmental Disabilities Administration (DDA).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Rationale."> <paragraph num="A."> <text>The Program shall:</text> <paragraph num="(1)"> <text>Assist a family to provide for the needs of a child or an adult with developmental disability living in the home; or</text> </paragraph> <paragraph num="(2)"> <text>Support an adult with developmental disability living in the community.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services shall be:</text> <paragraph num="(1)"> <text>Flexible to meet the needs of individuals or families; and</text> </paragraph> <paragraph num="(2)"> <text>Readily adaptive to changing needs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Program makes use of resources available in the community while, at the same time, building on the individual’s existing support network.</text> </paragraph> <paragraph num="D."> <text>Services provide quick access to supports for family and individual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Developmental Disabilities Administration (DDA) under the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Agency” means the selected licensed family and individual support program that administers the Program on behalf of the Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Camp” means a day camp, residential camp, travel camp, or trip camp that:</text> <paragraph num="(a)"> <text>During a calendar year, accommodates seven or more campers who are unrelated to the operator;</text> </paragraph> <paragraph num="(b)"> <text>Provides primarily recreational activities or has a substantial recreational component; and</text> </paragraph> <paragraph num="(c)"> <text>Operates on private property or private facilities, whether leased or owned, public property, or public facilities.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Child care” means the care or supervision for an individual, younger than 21 years old, who has a disability or other emotional, developmental, physical, educational, or medical need necessitating child care when the individual’s parent or legal guardian gives the individual’s care over to another for some portion of a 24-hour day as a supplement to the parent’s or guardian’s primary care of the child.</text> </paragraph> <paragraph num="(5)"> <text>“Day care” means the care provided to an individual 21 years old or older, who has a disability or other emotional, developmental, physical, educational, or medical need necessitating care from an adult day care center.</text> </paragraph> <paragraph num="(6)"> <text>“Eligible disability” means the individual has a severe chronic disability that:</text> <paragraph num="(a)"> <text>Is attributable to a physical or mental impairment, other than the sole diagnosis of mental illness, or to a combination of physical and mental impairments; and</text> </paragraph> <paragraph num="(b)"> <text>Is likely to continue indefinitely.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Dietitian and nutritionist services” mean:</text> <paragraph num="(a)"> <text>Nutrition care planning, nutrition assessment, and dietetic instruction; and</text> </paragraph> <paragraph num="(b)"> <text>Services within the scope of practice of the nutritionist's or dietitian's license, as defined by:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 5, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulations under COMAR 10.56 for the Board of Dietetic Practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Health services” means services:</text> <paragraph num="(a)"> <text>Provided by individuals regulated under the Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>That the respective licensing Board approves as a valid treatment for the presenting problem; and</text> </paragraph> <paragraph num="(c)"> <text>That include health assessments such as psychological, neuropsychological, dental, and speech-language assessments.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Housing Adaptations and Barrier Removals.</text> <paragraph num="(a)"> <text>“Housing adaptations and barrier removals” means those physical adaptations or modifications to the individual’s or family’s home which are required to make it accessible to the individual because of the:</text> <paragraph num="(i)"> <text>Physical structure of the residence; or</text> </paragraph> <paragraph num="(ii)"> <text>Individual’s specific functional needs.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Housing adaptations and barrier removals” may include but are not limited to:</text> <paragraph num="(i)"> <text>Visual fire alarms;</text> </paragraph> <paragraph num="(ii)"> <text>Ramps;</text> </paragraph> <paragraph num="(iii)"> <text>Grab bars or handrails;</text> </paragraph> <paragraph num="(iv)"> <text>Stair glides;</text> </paragraph> <paragraph num="(v)"> <text>Widening of doorways;</text> </paragraph> <paragraph num="(vi)"> <text>Modification of bathroom or kitchen facilities to make them physically accessible;</text> </paragraph> <paragraph num="(vii)"> <text>Specialized electrical and plumbing systems to accommodate the medical equipment and supplies which are necessary for the individual's welfare;</text> </paragraph> <paragraph num="(viii)"> <text>Locks, buzzers, or other devices on doorways to prevent or stop wandering; and</text> </paragraph> <paragraph num="(ix)"> <text>Home modifications to help a individual identify the physical environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Most integrated setting” means a setting that enables individuals with disabilities to interact with non-disabled persons to the fullest extent possible.</text> </paragraph> <paragraph num="(11)"> <text>“Program” means the Low Intensity Support Services Program that the Administration operates by contracting with approved Agencies.</text> </paragraph> <paragraph num="(12)"> <text>“Random selection process” means a system used to identify the applicants who will be considered for funding during Round 1 and Round 2 of each fiscal year, by using an automated system that does not consider the identity or any other personal aspect of the applicants.</text> </paragraph> <paragraph num="(13)"> <text>“Services” means low intensity support services as describe in this chapter.</text> </paragraph> <paragraph num="(14)"> <text>Specialized Equipment and Assistive Technology.</text> <paragraph num="(a)"> <text>“Specialized equipment and assistive technology” means non-experimental technology or adaptive equipment which:</text> <paragraph num="(i)"> <text>Enables an individual to live in the community and to participate in community activities; and</text> </paragraph> <paragraph num="(ii)"> <text>Meets applicable standards of manufacture, design, usage, and installation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Specialized Equipment and assistive technology” may include:</text> <paragraph num="(i)"> <text>Environmental control units for participants' homes to allow spontaneous or programmed control of household appliances and other home devices;</text> </paragraph> <paragraph num="(ii)"> <text>Devices with web-based operating systems, software, and computer accessories that enable participants to function more independently;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintenance and repair of the covered assistive technology devices and equipment, as necessary;</text> </paragraph> <paragraph num="(d)"> <text>Augmentative communication and communication-enhancement devices;</text> </paragraph> <paragraph num="(e)"> <text>Aids for daily living and self-help aids used in activities such as eating, bathing, cooking, dressing, toileting, and home maintenance; and</text> </paragraph> <paragraph num="(f)"> <text>Equipment needed to adapt the individual's or family's automotive vehicle for personal transportation such as:</text> <paragraph num="(i)"> <text>Adaptive driving aids;</text> </paragraph> <paragraph num="(ii)"> <text>Hand controls; and</text> </paragraph> <paragraph num="(iii)"> <text>Wheelchair lifts, and other lifts used for personal transportation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Therapy” means occupational, physical, speech, or behavioral therapy that is not funded by other State funded programs or by health insurance, including the Medical Assistance Program.</text> </paragraph> <paragraph num="(16)"> <text>“Therapeutic summer program” means a set of services designed to provide medical, behavioral, or psychological therapies, such as speech, applied behavior analysis, and occupational, through a variety of activities, in a safe environment, which are recommended by a licensed professional, and provided by clinical staff with clinical oversight.</text> </paragraph> <paragraph num="(17)"> <text>“Usual, customary, and reasonable” means the amount paid for a service in a geographic area that is based on what providers in the area typically charge for the same or similar service, so long as that charge is reasonable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Setting and Location."> <text>Services shall be provided within the individual’s home or a community setting in the most integrated setting.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Application and Eligibility."> <paragraph num="A."> <text>An individual shall submit to the Department:</text> <paragraph num="(1)"> <text>The completed LISS application form;</text> </paragraph> <paragraph num="(2)"> <text>For applicants younger than 21 years old, one of the following, demonstrating that the applicant meets the eligibility requirements for LISS:</text> <paragraph num="(a)"> <text>A finalized Individual Educational Program (IEP) from the current calendar year that identifies an eligible disability and that is in effect as of the date of the LISS application; or</text> </paragraph> <paragraph num="(b)"> <text>A statement written by a licensed physician, confirming that the individual has an eligible disability;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For applicants 21 years old or older, one of the following, demonstrating that the applicant meets the eligibility requirements for LISS:</text> <paragraph num="(a)"> <text>A statement written by a licensed physician within the last 3 years, confirming that the individual has an eligible disability;</text> </paragraph> <paragraph num="(b)"> <text>A psychological evaluation completed by a licensed professional within the last 3 years, confirming that the individual has an eligible disability;</text> </paragraph> <paragraph num="(c)"> <text>An evaluation completed by an Occupational Therapist, a Division of Rehabilitation Services evaluator, or another licensed professional within the last 3 years, confirming that the individual has an eligible disability; or</text> </paragraph> <paragraph num="(d)"> <text>A finalized IEP dated within 3 years after the date on which the applicant exited the school system, confirming that the individual has an eligible disability; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon request of the DDA, additional written evidence demonstrating that the criteria for specific services are met.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Eligibility.</text> <paragraph num="(1)"> <text>To be eligible for the Program, an individual:</text> <paragraph num="(a)"> <text>Shall be a Maryland resident and provide proof of address for the current calendar year;</text> </paragraph> <paragraph num="(b)"> <text>Shall have an eligible diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Shall provide proof of identity;</text> </paragraph> <paragraph num="(d)"> <text>May not be enrolled in any Maryland Medicaid home and community-based services waiver at the time of the random selection process, except that this restriction does not apply to applicants enrolled in the Maryland Model Waiver Program;</text> </paragraph> <paragraph num="(e)"> <text>May be enrolled in the Rare and Expensive Case Management (REM) Medicaid Program at the time of the random selection process;</text> </paragraph> <paragraph num="(f)"> <text>Shall submit a fully completed LISS application by the due dates established by the DDA; and</text> </paragraph> <paragraph num="(g)"> <text>Shall be selected by the random selection process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual currently receiving DDA services, other than coordination of community services, may not receive LISS funding under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An individual who received funding in Round 1 of the random selection process may not receive funding in Round 2 in the same fiscal year, even if the entire maximum amount of $2,000 was not awarded to the individual in Round 1.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The agency shall approve services for an eligible individual:</text> <paragraph num="(1)"> <text>Who is selected by the random selection process; and</text> </paragraph> <paragraph num="(2)"> <text>Whose requested services, items, and providers comply with the provisions of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Scope."> <paragraph num="A."> <text>Services funded under this program are intended to be, and are limited to, those that:</text> <paragraph num="(1)"> <text>Enhance the individual’s health or increase safety in the home environment;</text> </paragraph> <paragraph num="(2)"> <text>Support the individual to participate in the community;</text> </paragraph> <paragraph num="(3)"> <text>Enable the individual to remain in the individual’s own home or with the individual’s family;</text> </paragraph> <paragraph num="(4)"> <text>Strengthen the family’s ability to support the individual; or</text> </paragraph> <paragraph num="(5)"> <text>Enable the individual to develop and maintain skills.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services funded under this program may not duplicate services available to the individual in the community, education systems, or under an existing health plan, including Medical Assistance services.</text> </paragraph> <paragraph num="C."> <text>To be approved for funding, requested services and items:</text> <paragraph num="(1)"> <text>Shall be rendered by a provider whose administrative fee does not exceed 15 percent of the total cost of the item or service;</text> </paragraph> <paragraph num="(2)"> <text>May not be provided by a legally responsible person, as defined in Health General Article, §7-701(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Shall be rendered by a provider who is licensed by the State to perform the service;</text> </paragraph> <paragraph num="(4)"> <text>Shall be received:</text> <paragraph num="(a)"> <text>Except in accordance with §C(4)(b) of this regulation, within the same fiscal year as the request; and</text> </paragraph> <paragraph num="(b)"> <text>For summer camps, summer programs, and therapeutic programs, in June of the current fiscal year, or in July and August of the following fiscal year; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shall be approved in accordance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Covered Services."> <paragraph num="A."> <text>Services include supports involving:</text> <paragraph num="(1)"> <text>Attendant care services, including personal care;</text> </paragraph> <paragraph num="(2)"> <text>Camps that are:</text> <paragraph num="(a)"> <text>Approved by the MDH in accordance with COMAR 10.16.06;</text> </paragraph> <paragraph num="(b)"> <text>Accredited by the Maryland State Department of Education;</text> </paragraph> <paragraph num="(c)"> <text>Accredited by the American Camping Association certification;</text> </paragraph> <paragraph num="(d)"> <text>Approved by a State governmental entity; or</text> </paragraph> <paragraph num="(e)"> <text>Approved by the Developmental Disabilities Administration;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Child care that is provided in accordance with COMAR 13A.15, 13A.16, and 13A.18;</text> </paragraph> <paragraph num="(4)"> <text>Community integration services, including recreation programs;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, individual and family;</text> </paragraph> <paragraph num="(6)"> <text>Day care provided in accordance with Health General Article, §14-201(b) or §14-301(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Employment-related services;</text> </paragraph> <paragraph num="(8)"> <text>Health services, including dietetic and nutritional services;</text> </paragraph> <paragraph num="(9)"> <text>Housing adaptations and barrier removals provided that the applicant or the applicant’s family owns the property needing the adaptation;</text> </paragraph> <paragraph num="(10)"> <text>Identification services;</text> </paragraph> <paragraph num="(11)"> <text>Medical equipment purchase, rental, and repair;</text> </paragraph> <paragraph num="(12)"> <text>Recreation programs;</text> </paragraph> <paragraph num="(13)"> <text>Respite care and approved camps;</text> </paragraph> <paragraph num="(14)"> <text>Services to mediate, provide advice, or support the person or family to address their needs;</text> </paragraph> <paragraph num="(15)"> <text>Specialized equipment and assistive technology;</text> </paragraph> <paragraph num="(16)"> <text>Therapeutic services;</text> </paragraph> <paragraph num="(17)"> <text>Therapeutic summer programs;</text> </paragraph> <paragraph num="(18)"> <text>Training and support for self-advocacy;</text> </paragraph> <paragraph num="(19)"> <text>Transportation.</text> </paragraph> <paragraph num="(20)"> <text>Tuition for post-secondary academic and vocational services;</text> </paragraph> <paragraph num="(21)"> <text>Tutoring for post-secondary academic and vocational services; and</text> </paragraph> <paragraph num="(22)"> <text>Repairs of vehicles that have been modified or adapted with specialized equipment to meet the needs of the eligible individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration may approve other services that meet the requirements of Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The agency approving or procuring requested dietitian and nutritionist services referenced in §A(7) of this regulation shall be sensitive to the educational background, culture, religion, eating habits, preferences, and general environment of the individual.</text> </paragraph> <paragraph num="D."> <text>To be approved for funding, all requested medical services, and therapies:</text> <paragraph num="(1)"> <text>Shall be prescribed by a professional authorized to do so under the Health Occupations Article, Annotated Code of Maryland, in the relevant field;</text> </paragraph> <paragraph num="(2)"> <text>Shall be provided or supervised by an organization authorized to do so under the Health Occupations Article, Annotated Code of Maryland, in the relevant field;</text> </paragraph> <paragraph num="(3)"> <text>Shall be prescribed for treatment of a specified illness or condition, or for amelioration of the symptoms of a specified illness or condition;</text> </paragraph> <paragraph num="(4)"> <text>Shall be a treatment that is approved by the:</text> <paragraph num="(a)"> <text>Respective Health Occupations licensing board; and</text> </paragraph> <paragraph num="(b)"> <text>The Federal Drug Administration (FDA), if the FDA regulates the treatment; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>May not be:</text> <paragraph num="(a)"> <text>Related to the individual’s primary or secondary education; and</text> </paragraph> <paragraph num="(b)"> <text>Covered by the individual’s IEP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>To be approved for funding, all providers of housing adaptations and barrier removal services shall:</text> <paragraph num="(1)"> <text>Be properly licensed or certified by the State to provide the service being rendered;</text> </paragraph> <paragraph num="(2)"> <text>Be bonded as is legally required;</text> </paragraph> <paragraph num="(3)"> <text>Obtain all required State and local permits;</text> </paragraph> <paragraph num="(4)"> <text>Pass final required inspections; and</text> </paragraph> <paragraph num="(5)"> <text>Perform all work in accordance with State and local building codes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Program Funding."> <paragraph num="A."> <text>The Program is not an entitlement program and does not create a right to funding.</text> </paragraph> <paragraph num="B."> <text>Funding is not transferable, and the amount funded may not exceed the amount initially requested on the application.</text> </paragraph> <paragraph num="C."> <text>Amount of Funding.</text> <paragraph num="(1)"> <text>The agency may approve funding for an eligible individual for services up to $2,000 per fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>Requests for amounts exceeding $2,000 may not be considered.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The agency may not fund a request for services unless the service or support meets the requirements of this chapter.</text> </paragraph> <paragraph num="E."> <text>Exclusions.</text> <paragraph num="(1)"> <text>Treatments and therapies that are not generally accepted by the relevant scientific community may not be provided or funded.</text> </paragraph> <paragraph num="(2)"> <text>The Program may not provide or fund the following:</text> <paragraph num="(a)"> <text>Housing adaptations or improvements to an individual’s home that adds to the home’s total square footage; and</text> </paragraph> <paragraph num="(b)"> <text>Adaptations or modifications that restrict an individual’s movement or jeopardize the individual’s welfare.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Program may not provide or cover the following:</text> <paragraph num="(a)"> <text>Cash;</text> </paragraph> <paragraph num="(b)"> <text>Case management;</text> </paragraph> <paragraph num="(c)"> <text>Gift cards;</text> </paragraph> <paragraph num="(d)"> <text>Presents;</text> </paragraph> <paragraph num="(e)"> <text>Toys, except those recommended by an individual authorized under the Health Occupations Article, Annotated Code of Maryland, for specified therapeutic purposes;</text> </paragraph> <paragraph num="(f)"> <text>Vacations;</text> </paragraph> <paragraph num="(g)"> <text>Vehicle gas, tires, registration fees, loan payments, insurance coverage, and penalties for violations, such as tickets and fines; and</text> </paragraph> <paragraph num="(h)"> <text>Housing assistance, including eviction assistance, utility disconnection, and deposits.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeals."> <paragraph num="A."> <text>Pursuant to Health-General Article, §7-406, Annotated Code of Maryland, and COMAR 10.22.16:</text> <paragraph num="(1)"> <text>On any action or inaction of the Secretary under Regulations .01 — .08 of this chapter, other than non-selection through the random selection process, an applicant for services may request:</text> <paragraph num="(a)"> <text>An informal hearing before the Secretary’s designee; and</text> </paragraph> <paragraph num="(b)"> <text>The Secretary to review the decision of the informal hearing if that decision is not acceptable;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Informal hearings under §A(1)(a) of this regulation are conducted in accordance with COMAR 10.22.16; and</text> </paragraph> <paragraph num="(3)"> <text>After a request for a review is made, the Secretary shall conduct the review in accordance with Title 10, Subtitle 2 of the State Government Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary may deny a request for hearing if the reason for the appeal is to contest a denial of services due to lack of available budgeted funds.</text> </paragraph> <paragraph num="C."> <text>A person aggrieved by a final decision of the Secretary in a contested case as defined in State Government Article, §10-201, Annotated Code of Maryland, may take an appeal as allowed in State Government Article, §§10-215 and 10-216, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Program Agencies — Eligibility and Responsibilities."> <paragraph num="A."> <text>The agency that administers the Program shall:</text> <paragraph num="(1)"> <text>Be licensed under COMAR 10.22.06 as an Individual and Family Support Program;</text> </paragraph> <paragraph num="(2)"> <text>Have been awarded a contract to administer the Program under the Administration’s competitive procurement process; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain an operational procedure manual that is approved by DDA.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Funding of Services. The agency shall fund services as follows:</text> <paragraph num="(1)"> <text>Fund only services that meet the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Fund services at the rates set forth in the contract;</text> </paragraph> <paragraph num="(3)"> <text>Fund procured services based on the usual, customary, and reasonable rate for the service provided; and</text> </paragraph> <paragraph num="(4)"> <text>Fund housing adaptations and barrier removals referenced in Regulation .07A(8) of this chapter, including the cost of the physical adaptation and associated costs for installation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The agency shall deny funding if:</text> <paragraph num="(1)"> <text>The applicant does not meet eligibility criteria;</text> </paragraph> <paragraph num="(2)"> <text>The service or item requested is not permitted to be provided or funded by this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>The provider of the service does not meet the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Implementation Date."> <text>This chapter shall be implemented July 1, 2015.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-703, 7-708, 7-717, and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 23, 2012 (39:14 Md. R. 838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 24, 2016 (43:21 Md. R. 1166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 24, 2016 (43:21 Md. R. 1166)</annotation> </annotations> </chapter> <chapter num="15" heading="Waiting List Equity Fund"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations address the management and use of money in the waiting list equity fund.</text> </paragraph> <paragraph num="B."> <text>The waiting list equity fund may not be used to supplant funds requested or appropriated for:</text> <paragraph num="(1)"> <text>Emergency community placements; or</text> </paragraph> <paragraph num="(2)"> <text>Transitioning students.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Developmental Disabilities Administration (DDA).</text> </paragraph> <paragraph num="(2)"> <text>“Appropriate evaluation” means the assessment of an individual using accepted professional standards to determine the presence or absence of a developmental disability:</text> <paragraph num="(a)"> <text>As defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>That qualifies the individual for individual support services only as defined in Health-General Article, §7-403(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Community placement” means when an individual is discharged from a State residential center into the community and receives community-based services.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Developmental disability” means a severe, chronic disability of an individual that:</text> <paragraph num="(a)"> <text>Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments;</text> </paragraph> <paragraph num="(b)"> <text>Is manifested before the individual becomes 22 years old;</text> </paragraph> <paragraph num="(c)"> <text>Is likely to continue indefinitely;</text> </paragraph> <paragraph num="(d)"> <text>Results in an inability to live independently without external support or continuing and regular assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Eligibility for support services only” means an individual has a severe chronic disability that is:</text> <paragraph num="(a)"> <text>Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and</text> </paragraph> <paragraph num="(b)"> <text>Likely to continue indefinitely.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Family caregiver” means any of the following who is residing with the eligible individual:</text> <paragraph num="(a)"> <text>Spouse;</text> </paragraph> <paragraph num="(b)"> <text>Biological, adoptive, or foster parent;</text> </paragraph> <paragraph num="(c)"> <text>Guardian;</text> </paragraph> <paragraph num="(d)"> <text>Sibling;</text> </paragraph> <paragraph num="(e)"> <text>Grandparent; or</text> </paragraph> <paragraph num="(f)"> <text>Other related next of kin.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Family Support Services.</text> <paragraph num="(a)"> <text>“Family support services” means a program designed to enable a family to provide for the needs of a child with developmental disability living in the family home.</text> </paragraph> <paragraph num="(b)"> <text>“Family support services” includes:</text> <paragraph num="(i)"> <text>Individual and family counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Personal care;</text> </paragraph> <paragraph num="(iii)"> <text>Day care;</text> </paragraph> <paragraph num="(iv)"> <text>Specialized equipment;</text> </paragraph> <paragraph num="(v)"> <text>Health services;</text> </paragraph> <paragraph num="(vi)"> <text>Respite care;</text> </paragraph> <paragraph num="(vii)"> <text>Housing adaptations; and</text> </paragraph> <paragraph num="(viii)"> <text>Transportation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Individual” means the person for whom an application for services has been filed with the Administration.</text> </paragraph> <paragraph num="(10)"> <text>Individual Support Services.</text> <paragraph num="(a)"> <text>“Individual support services” means an array of services that are designed to increase or maintain an individual's ability to live alone or in a family setting.</text> </paragraph> <paragraph num="(b)"> <text>“Individual support services” includes:</text> <paragraph num="(i)"> <text>In-home assistance with meals and personal care;</text> </paragraph> <paragraph num="(ii)"> <text>Counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Physical, occupational, or other therapies;</text> </paragraph> <paragraph num="(iv)"> <text>Architectural modification; and</text> </paragraph> <paragraph num="(v)"> <text>Other services that the Administration considers appropriate to meet an individual's needs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Individualized community integration day services” means any full-time or part-time program of habilitation, health-related services, scheduled training, or skills development activities conducted outside the individual's home.</text> </paragraph> <paragraph num="(12)"> <text>Individualized Supported Living Arrangements Services.</text> <paragraph num="(a)"> <text>“Individualized supported living arrangements services” means residential services provided in alternative living units (ALUs), community supported living arrangements (CSLA), and any other community residential arrangement which is individualized.</text> </paragraph> <paragraph num="(b)"> <text>“Individualized supported living arrangements services” does not include group homes.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Previous resident of a State residential center” means an individual who:</text> <paragraph num="(a)"> <text>Was a resident of that facility on the first day of that fiscal year; and</text> </paragraph> <paragraph num="(b)"> <text>Had resided at the facility at least 120 days during the 180 days immediately preceding placement in the community.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Respite care” means short-term care not to exceed 14 consecutive days or 28 days in a 12-month period that is made available to provide relief for the individual with whom the developmentally disabled individual ordinarily lives.</text> </paragraph> <paragraph num="(15)"> <text>“State residential center (SRC)” means a place that:</text> <paragraph num="(a)"> <text>Is owned and operated by the State;</text> </paragraph> <paragraph num="(b)"> <text>Provides residential services for an individual with an intellectual disability and who, because of an intellectual disability, requires specialized living arrangements and meets the criteria under Health-General Article, §§7-502 and 7-505, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Admits nine or more individuals with intellectual disabilities.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Supported employment” means paid competitive employment in an integrated work setting consistent with the federal Rehabilitation Act 1992 amendments.</text> </paragraph> <paragraph num="(17)"> <text>“Waiting list” means those individuals who have:</text> <paragraph num="(a)"> <text>Applied for services from the Administration in accordance with COMAR 10.22.12.04;</text> </paragraph> <paragraph num="(b)"> <text>Been considered eligible for services in accordance with COMAR 10.22.12.06; and</text> </paragraph> <paragraph num="(c)"> <text>Not yet received services for which they have applied from the Administration.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Waiting list equity fund (WLEF)” means the fund established according to the requirements specified in Health-General Article, §7-206, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Establishment of the Waiting List Equity Fund."> <paragraph num="A."> <text>The waiting list equity fund is a nonlapsing fund established to ensure that when an individual leaves the State residential center to be served in the community, the net average cost of serving the individual in the SRC is applied to:</text> <paragraph num="(1)"> <text>The individual's community placement;</text> </paragraph> <paragraph num="(2)"> <text>Community services needed to sustain the individual's community placement; and</text> </paragraph> <paragraph num="(3)"> <text>Provide community-based services to individuals not yet receiving services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The WLEF consists of funds that are equal to the cost of providing services to an individual in an SRC for a fiscal year, or part of a fiscal year in which the individual is:</text> <paragraph num="(1)"> <text>No longer served in the SRC; and</text> </paragraph> <paragraph num="(2)"> <text>Provided community-based services as specified in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In determining the contribution to the WLEF, the Administration shall calculate the cost of providing services to an individual in an SRC by:</text> <paragraph num="(1)"> <text>Dividing the SRC's appropriation by the daily average census reported in the SRC's annual operating budget for the last full fiscal year the individual was served in the SRC, prorated over the number of months the individual is served in the community; and</text> </paragraph> <paragraph num="(2)"> <text>Subtracting the following:</text> <paragraph num="(a)"> <text>The average annual itemized expenses associated with institutional services and administrative overhead costs that are demonstrated to be directly attributable to the individuals remaining in the SRC,</text> </paragraph> <paragraph num="(b)"> <text>The cost for new admissions certified with the provisions of Health-General Article, §§7-502 and 7-503, Annotated Code of Maryland,</text> </paragraph> <paragraph num="(c)"> <text>The cost for respite care in accordance with Health-General Article, §7-509, Annotated Code of Maryland, which is based on the identification of the actual, specific costs directly attributable to serving individuals in the SRC with respite care services,</text> </paragraph> <paragraph num="(d)"> <text>The cost for court-ordered commitments, and</text> </paragraph> <paragraph num="(e)"> <text>Federal revenues under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) attributable to direct client cost.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Administration shall allocate to the WLEF overhead savings derived from the closing of an individual cottage or cottages.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Submission of Annual Budget."> <paragraph num="A."> <text>When submitting its annual budget request for community services programs, the Administration shall include funds for the ongoing cost of services for the number of:</text> <paragraph num="(1)"> <text>Previous residents placed from the SRC into the community in the previous fiscal year using the WLEF;</text> </paragraph> <paragraph num="(2)"> <text>Individuals receiving emergency placements using the WLEF; and</text> </paragraph> <paragraph num="(3)"> <text>Individuals receiving nonemergency placements using the WLEF.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration shall reduce the budget submission for the SRC by the net average cost of serving an individual in that center, as defined in Regulation .03C(2) of this chapter.</text> </paragraph> <paragraph num="C."> <text>The Administration shall calculate the net average cost on a prorated basis if an individual was placed in the community for less than the entire fiscal year.</text> </paragraph> <paragraph num="D."> <text>The Administration may increase or decrease the budget request for each SRC to account for the increased cost of services to the remaining residents of the SRC.</text> </paragraph> <paragraph num="E."> <text>If the Administration requests additional amounts for the purpose of funding community placements for current residents of SRCs, the Administration shall request that additional funding in a separate category from funds for the WLEF.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Administration of Fund."> <paragraph num="A."> <text>The Administration shall authorize the funding of services through the WLEF, administered as a nonlapsing revenue account, only to the extent that an appropriation has been made and that funds are available in the WLEF.</text> </paragraph> <paragraph num="B."> <text>The WLEF may be used to provide services to individuals who are:</text> <paragraph num="(1)"> <text>In crisis and need emergency services; and</text> </paragraph> <paragraph num="(2)"> <text>Not in crisis and do not need emergency services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The WLEF may not be used to supplant funds appropriated for:</text> <paragraph num="(1)"> <text>Emergency community placements; or</text> </paragraph> <paragraph num="(2)"> <text>Transitioning students.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To determine the amount of funds available from the WLEF at any time during a fiscal year, the Administration shall project the cost for community services for that year for each individual whose services are funded through the WLEF.</text> </paragraph> <paragraph num="E."> <text>If approved by the Administration, the Administration shall include the following items in the projected costs:</text> <paragraph num="(1)"> <text>The cost of the services provided to the individual;</text> </paragraph> <paragraph num="(2)"> <text>Any increase in the cost of services being provided to the individual; and</text> </paragraph> <paragraph num="(3)"> <text>Any increase in costs due to a change in the amount or type of services provided to the individual.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Administration shall account for all transactions into and out of the WLEF at the project level.</text> </paragraph> <paragraph num="G."> <text>The Administration shall ensure that all interest earned on the money in the WLEF remains with the fund.</text> </paragraph> <paragraph num="H."> <text>The availability of funding through the WLEF does not establish an entitlement to services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Eligibility Criteria."> <paragraph num="A."> <text>To be eligible for services funded from the waiting list equity fund, an individual shall:</text> <paragraph num="(1)"> <text>Be a resident of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have an appropriate evaluation that finds that the individual:</text> <paragraph num="(a)"> <text>Has a developmental disability, or</text> </paragraph> <paragraph num="(b)"> <text>Is eligible for support services;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Leave a State residential center on or after October 1, 1994, to be served in community-based services as specified in Regulation .05A of this chapter; or</text> </paragraph> <paragraph num="(4)"> <text>Be in the community on the waiting list for community-based services in one of the following categories:</text> <paragraph num="(a)"> <text>Crisis resolution,</text> </paragraph> <paragraph num="(b)"> <text>Crisis prevention, or</text> </paragraph> <paragraph num="(c)"> <text>Current request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A determination made under §A(2) of this regulation may be reopened on the provision of an additional evaluation after 1 year from the initial evaluation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Services."> <paragraph num="A."> <text>The Administration shall ensure that the waiting list equity fund is used to provide the following community-based services to eligible individuals in accordance with the individual's needs:</text> <paragraph num="(1)"> <text>Individual and family support services;</text> </paragraph> <paragraph num="(2)"> <text>Respite care;</text> </paragraph> <paragraph num="(3)"> <text>Supported employment;</text> </paragraph> <paragraph num="(4)"> <text>Individualized community integration day services; and</text> </paragraph> <paragraph num="(5)"> <text>Individualized supported living arrangements services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration shall consider the following criteria when deciding priority for services:</text> <paragraph num="(1)"> <text>80 percent of the WLEF monies are to be spent for individuals not in crisis and who do not need emergency services;</text> </paragraph> <paragraph num="(2)"> <text>20 percent of the WLEF monies are to be spent for individuals in crisis and who need emergency services after all emergency funds have been expended on a regional basis;</text> </paragraph> <paragraph num="(3)"> <text>Individuals who are not in crisis and who do not need emergency services are defined in COMAR 10.22.12;</text> </paragraph> <paragraph num="(4)"> <text>Individuals who are in crisis and who need emergency services are defined in COMAR 10.22.12; and</text> </paragraph> <paragraph num="(5)"> <text>For nonemergencies, individuals and their families shall receive services in the following priority order:</text> <paragraph num="(a)"> <text>Oldest age of family caregiver, by the date of birth, in descending order, and</text> </paragraph> <paragraph num="(b)"> <text>If there are two caregivers of the same age next to be served and funding is available to support only one, priority is given to the individual on the crisis prevention list.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Review and Reporting Requirements."> <paragraph num="A."> <text>On or before January 1 of each year, the Administration shall prepare a report to be submitted to the General Assembly and the Department of Fiscal Services on the waiting list equity fund.</text> </paragraph> <paragraph num="B."> <text>The Administration shall include in the report:</text> <paragraph num="(1)"> <text>An accounting of all receipts and expenditures to and from the fund;</text> </paragraph> <paragraph num="(2)"> <text>The number of individuals who left and entered State residential centers during the previous year;</text> </paragraph> <paragraph num="(3)"> <text>The number of additional individuals who were on the waiting list for services from the Administration during the previous year; and</text> </paragraph> <paragraph num="(4)"> <text>An accounting of each factor used to determine the cost of providing services to an individual in a State residential center in accordance with the provisions stated in Health-General Article, §7-206, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Administration shall:</text> <paragraph num="(1)"> <text>Review the needs of individuals on the waiting list by July 1, 1998; and</text> </paragraph> <paragraph num="(2)"> <text>Modify these regulations, as appropriate, to respond to the needs of the individuals on the waiting list.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Administrative and Judicial Review."> <paragraph num="A."> <text>An individual has the right to appeal an action or inaction with respect to this chapter in accordance with Health-General Article, §7-406, Annotated Code of Maryland, and COMAR 10.22.16.</text> </paragraph> <paragraph num="B."> <text>An individual may prevail at the appeal only upon a showing that the agency has violated statutory or regulatory provisions by its action or inaction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Eligibility for Other Services."> <paragraph num="A."> <text>An individual's eligibility for services provided by any other public or private agency may not be affected by the individual's eligibility for services under this chapter.</text> </paragraph> <paragraph num="B."> <text>An individual who is eligible for services funded by the Administration may also be eligible for services provided by another agency.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 adopted as an emergency provision effective February 27, 1996 (23:6 Md. R. 470); emergency status extended to September 23, 1996 (23:14 Md. R. 1006); adopted permanently effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.22.08 recodified to COMAR 10.22.15 effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> </annotations> </chapter> <chapter num="16" heading="Informal Hearings Under the Maryland Developmental Disabilities Law"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the hearing which an applicant for or a recipient of Developmental Disabilities Administration services may request under Health-General Article, §7-406(a)(1), Annotated Code of Maryland. Nothing in these regulations shall be construed to create an entitlement to services provided or funded by the Department or the Administration.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose."> <text>The purpose of the informal hearing procedure is to seek informal and expeditious resolution when an applicant for or recipient of services is dissatisfied as a result of the Secretary's actions or inactions under Health-General Article, Title 7.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Action or inaction of the Secretary” means a decision of the Deputy Secretary or an authorized representative of the Deputy Secretary, that:</text> <paragraph num="(a)"> <text>Denies an application by an individual for eligibility for services;</text> </paragraph> <paragraph num="(b)"> <text>Denies a request for services made by a recipient of services;</text> </paragraph> <paragraph num="(c)"> <text>Terminates, reduces, suspends, or withdraws services for a recipient of services; or</text> </paragraph> <paragraph num="(d)"> <text>Otherwise denies a request made by a recipient of services that is related to DDA services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Developmental Disabilities Administration (DDA).</text> </paragraph> <paragraph num="(3)"> <text>“Appellant” means the person or that person's representative who has applied for or received Administration services and who has requested a hearing pursuant to Health-General Article, §7-406, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Applicant for services” means a person who has applied for services and is subject to the Administration's determination of eligibility. In addition, the following representatives are considered applicants for the purpose of these regulations:</text> <paragraph num="(a)"> <text>A parent of an applicant who is a minor;</text> </paragraph> <paragraph num="(b)"> <text>The applicant's court-appointed guardian of the person;</text> </paragraph> <paragraph num="(c)"> <text>An attorney representing the applicant; and</text> </paragraph> <paragraph num="(d)"> <text>A person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA licensed, operated, or funded program.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Department's representative” means the person designated by the Director to represent the Department in the hearing and to defend the action or inaction of the Secretary.</text> </paragraph> <paragraph num="(7)"> <text>“Director” means the Director of the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(8)"> <text>“Hearing” means the informal hearing provided for in Health-General Article, §7-406(a)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Party” means an appellant or the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Recipient of services” means a person who has received Administration services. In addition, the following representatives are considered recipients for the purpose of these regulations:</text> <paragraph num="(a)"> <text>A parent of a recipient who is a minor;</text> </paragraph> <paragraph num="(b)"> <text>The recipient's court-appointed guardian of the person;</text> </paragraph> <paragraph num="(c)"> <text>An attorney representing the recipient; and</text> </paragraph> <paragraph num="(d)"> <text>A person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA licensed, operated, or funded program.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Secretary” means the Secretary of Health and or a representative appointed by the Secretary.</text> </paragraph> <paragraph num="(12)"> <text>“Secretary's designee” means the employee of the Department chosen by the Director to conduct the hearing and make administrative decisions in accordance with these regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Notification of Right to Request a Hearing."> <text>The Administration shall:</text> <paragraph num="A."> <text>Provide written notification of the right to request a hearing and the method of obtaining the hearing to each applicant for or recipient of services at the time of application, and at any time the Administration decides to deny, terminate, reduce, suspend, withdraw or transfer, or otherwise significantly alter any service to an applicant or recipient;</text> </paragraph> <paragraph num="B."> <text>Include in the notification the following statements:</text> <paragraph num="(1)"> <text>That the applicant or recipient:</text> <paragraph num="(a)"> <text>Has a right to a hearing upon request regarding any action or inaction of the Secretary made under Health-General Article, Title 7, Annotated Code of Maryland, which affects service provision to the applicant or recipient,</text> </paragraph> <paragraph num="(b)"> <text>May choose to waive the right to an informal hearing, and</text> </paragraph> <paragraph num="(c)"> <text>Has the right to a formal hearing in accordance with State Government Article, Title 10, Subtitle 2;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a decision has been made by the Secretary, the factual basis for the decision;</text> </paragraph> <paragraph num="(3)"> <text>That a hearing shall be requested within 45 days of the date the notification is postmarked if a decision has been made by the Department, or within 45 days following the action or inaction which is the subject of the appeal;</text> </paragraph> <paragraph num="(4)"> <text>The procedure the applicant or recipient is required to follow in order to timely request a hearing; and</text> </paragraph> <paragraph num="(5)"> <text>That unless an informal or formal hearing is requested within the prescribed time period, the Secretary's intended action will become final;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Enclose with the written notification a form to be used to request a hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Request for Hearing."> <paragraph num="A."> <text>An applicant or recipient, or the applicant's or recipient's representative, may request a hearing by mailing or delivering a clear, written statement to the Director of the Administration. The request shall state:</text> <paragraph num="(1)"> <text>That the applicant or recipient desires a hearing; and</text> </paragraph> <paragraph num="(2)"> <text>The specific action or inaction of the Secretary which the applicant or recipient seeks to challenge.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration shall acknowledge in writing a request for a hearing within 10 days of the postmark of the request.</text> </paragraph> <paragraph num="C."> <text>The Administration shall give reasonable advance notice in writing to the appellant of the issue or issues to be decided, the date, time, and place of the hearing, the right to be present, the right to be represented by an attorney, and the right to request and present witnesses and documentary evidence.</text> </paragraph> <paragraph num="D."> <text>Unless agreed upon by all parties, the Administration shall hold the hearing not sooner than 10 days but not later than 30 days after the mailing of the acknowledgement. The Administration may consolidate various requests for hearings made by or on behalf of a particular individual when there is significant similarity in facts or issues to be resolved.</text> </paragraph> <paragraph num="E."> <text>The Administration shall make reasonable efforts to schedule the hearing at a time and place convenient to all parties.</text> </paragraph> <paragraph num="F."> <text>A request for a hearing shall be made within 45 days of the postmark of the notification specified in Regulation .04A, or if Regulation .04A does not apply, within 45 days following the action. When the subject of the appeal is an inaction, a request for a hearing shall be made within 45 days after the applicant or recipient actually knew or should reasonably have known of the inaction.</text> </paragraph> <paragraph num="G."> <text>A request for an extension of the time to request a hearing may be granted by the Secretary's designee for good cause shown.</text> </paragraph> <paragraph num="H."> <text>The Department may dismiss a request for a hearing when it has been withdrawn or abandoned by the appellant. The Department may find that a request for a hearing has been abandoned if, after receiving proper notice, the appellant:</text> <paragraph num="(1)"> <text>Does not appear for the hearing on the established date; and</text> </paragraph> <paragraph num="(2)"> <text>Fails to notify the Department of the reason for nonappearance.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Department is only required to grant one informal hearing as to any one action or inaction of the Secretary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Implementation of Action of the Secretary."> <paragraph num="A."> <text>The action of the Secretary, which is the subject of a request for a hearing, may not be implemented unless the:</text> <paragraph num="(1)"> <text>Secretary has determined that an emergency exists when to delay action for a hearing would have a serious and adverse affect on the health or safety of any person;</text> </paragraph> <paragraph num="(2)"> <text>Applicant or recipient has withdrawn or abandoned the request for a hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Applicant or recipient has failed in the applicant's or recipient's challenge of any action or inaction of the Secretary under Health-General Article, §7-406, Annotated Code of Maryland, and the enforcement of the final decision has not been stayed pursuant to State Government Article, §10-215.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When a request for a hearing has been made and the appellant is asking that the Secretary take certain action, the requested action need not be implemented unless the appellant is successful in the appellant's challenge under Health-General Article, §7-406.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Secretary's Designee."> <paragraph num="A."> <text>The Director shall, in response to a request for a hearing, choose an employee of the Department to conduct the hearing and issue an administrative decision.</text> </paragraph> <paragraph num="B."> <text>An individual may not serve as the Secretary's designee if, as to this hearing, the individual:</text> <paragraph num="(1)"> <text>Was involved in policy or decision-making regarding the particular action or inaction of the Secretary which is the subject of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>Has a personal financial interest in the matter; or</text> </paragraph> <paragraph num="(3)"> <text>Is related by blood or marriage to the appellant or to the Department's representative.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The appellant shall be informed before the hearing of the identity of the Secretary's designee, and shall have the right to object based on factors noted in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Powers and Duties of Secretary's Designee."> <paragraph num="A."> <text>The Secretary's designee shall have authority to:</text> <paragraph num="(1)"> <text>Engage in reasonable efforts to secure the attendance of witnesses;</text> </paragraph> <paragraph num="(2)"> <text>Conduct a full, fair, and impartial hearing;</text> </paragraph> <paragraph num="(3)"> <text>Take action to avoid unnecessary delay and duplication in the proceedings; and</text> </paragraph> <paragraph num="(4)"> <text>Maintain order.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary's designee:</text> <paragraph num="(1)"> <text>Shall rule on the admissibility of any documentary evidence and on the appearance and testimony of any witness;</text> </paragraph> <paragraph num="(2)"> <text>May question any party or witness; and</text> </paragraph> <paragraph num="(3)"> <text>Shall permit examination of witnesses.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Prehearing."> <paragraph num="A."> <text>The appellant and the Department's representative are encouraged to engage in informal discussions before the hearing for the purpose of sharing documentary evidence, clarifying facts, resolving issues, and making recommendations to the Secretary's designee regarding areas of agreement and disagreement and the conduct of the hearing. The appellant shall immediately notify the Secretary's designee if and when there has been a resolution of the appellant's concern which results in the appellant withdrawing the request for a hearing.</text> </paragraph> <paragraph num="B."> <text>Written communications and substantive verbal communications between a party and the Secretary's designee shall be shared with all other parties before the hearing or, if not possible, at the hearing.</text> </paragraph> <paragraph num="C."> <text>All parties shall make reasonable efforts to comply with the request of other parties to:</text> <paragraph num="(1)"> <text>Preview relevant records and other written material and to permit discussions with relevant persons before the hearing;</text> </paragraph> <paragraph num="(2)"> <text>Introduce into evidence at the hearing relevant records and other written material, and secure the appearance and cooperation of relevant witnesses, including the applicant or recipient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Hearing Procedure."> <paragraph num="A."> <text>The appellant shall have the right to request that the hearing be closed to the public. The Secretary's designee shall grant the appellant's request for a closed hearing if the Secretary's designee, after hearing from the parties, determines that the appellant's interest in confidentiality and privacy outweighs the value to the public of an open hearing.</text> </paragraph> <paragraph num="B."> <text>The Secretary's designee shall call the case to order and explain the issue or issues to be decided and the hearing procedure.</text> </paragraph> <paragraph num="C."> <text>The appellant shall present the reasons the appellant objects to the Secretary's actions or inactions and the appellant's argument for the relief requested.</text> </paragraph> <paragraph num="D."> <text>All parties shall have the opportunity to present evidence, call witnesses, and question the other party's witnesses.</text> </paragraph> <paragraph num="E."> <text>In order to clarify relevant facts, the Secretary's designee may question any person at any time during the hearing.</text> </paragraph> <paragraph num="F."> <text>With the consent of both parties, the Secretary's designee may allow discussion of the issues among the parties and relevant witnesses in order to seek resolution.</text> </paragraph> <paragraph num="G."> <text>The applicant or recipient and that person's representative or representatives shall have the right to testify at the hearing.</text> </paragraph> <paragraph num="H."> <text>The Secretary's designee may, with consent of the parties, conduct all or part of a hearing by telephone if each party in the hearing has an opportunity to participate in and hear the entire proceeding while it is taking place.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Burden of Persuasion."> <text>The appellant bears the burden of persuasion and may not prevail unless the appellant convinces the Secretary's designee by a preponderance of the evidence that the Secretary's action or inaction was incorrect.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="The Record."> <text>The Secretary's designee shall:</text> <paragraph num="A."> <text>Maintain the official record of the hearing;</text> </paragraph> <paragraph num="B."> <text>Include in the official record of the hearing:</text> <paragraph num="(1)"> <text>Official correspondence regarding the hearing, including the request for the hearing and the Secretary's response,</text> </paragraph> <paragraph num="(2)"> <text>Written material submitted by the parties,</text> </paragraph> <paragraph num="(3)"> <text>Evidence admitted by the Secretary's designee,</text> </paragraph> <paragraph num="(4)"> <text>A tape recording of the hearing, and</text> </paragraph> <paragraph num="(5)"> <text>The decision of the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Decision of the Secretary's Designee."> <paragraph num="A."> <text>The Secretary's designee shall decide a case within 14 days of the hearing based upon the entire record in the case and according to the burden of persuasion set forth in Regulation .11. The Secretary's designee may communicate with the parties for the purpose of developing a decision agreeable to all parties provided the Secretary's designee complies with Regulation .09B.</text> </paragraph> <paragraph num="B."> <text>The Secretary's designee shall prepare a written decision which includes the following statements:</text> <paragraph num="(1)"> <text>The issues presented for resolution;</text> </paragraph> <paragraph num="(2)"> <text>Whether the appellant met the burden of persuasion as to each issue;</text> </paragraph> <paragraph num="(3)"> <text>To what extent, if any, the relief requested by the appellant is being granted;</text> </paragraph> <paragraph num="(4)"> <text>What, if any, action the Department is required to take and when the action shall occur; and</text> </paragraph> <paragraph num="(5)"> <text>The appellant's right to appeal the decision of the Secretary's designee pursuant to Health-General Article, §7-406, Annotated Code of Maryland, if the relief requested was not granted.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary's designee shall promptly deliver or mail copies of the final decision to all parties.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7-401 and 7-406, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 21, 1975 (2:7 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Preface amended effective December 29, 1975 (3:4 Md. R. 217)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Public and Private Residential Care Facilities Serving the Mentally Retarded (I.C.F—M.R.), repealed effective December 28, 1987 (14:26 Md. R. 2747)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 Informal Hearings Under the Maryland Developmental Disabilities Law, adopted effective December 25, 1989 (16:25 Md. R. 2713)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.22.04 recodified to COMAR 10.22.16 effective July 26, 1999 (26:15 Md. R. 1148)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 31, 2018 (45:26 Md. R. 1245)</annotation> </annotations> </chapter> <chapter num="17" heading="Fee Payment System for Licensed Residential and Day Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes the methodology that the Department shall use to reimburse:</text> <paragraph num="(1)"> <text>Licensed residential alternative living units, residential group homes, day habilitation programs, and vocational programs that provide services to individuals with disabilities after June 30, 1998;</text> </paragraph> <paragraph num="(2)"> <text>Supported employment provided by licensed providers of services to individuals after June 30, 2001;</text> </paragraph> <paragraph num="(3)"> <text>Add-on component services for individuals in these programs; and</text> </paragraph> <paragraph num="(4)"> <text>Supplemental services for individuals in these programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services reimbursed under this chapter are funded by Medicaid funds and, in whole or in part, by State general funds.</text> </paragraph> <paragraph num="C."> <text>When the reimbursement for a service is based on an established rate under this chapter, the rate is based on the service needs of the individual, an allowance for indirect expenses incurred by providers, and the regional location of the services.</text> </paragraph> <paragraph num="D."> <text>The Administration may contract for additional services according to the State procurement laws.</text> </paragraph> <paragraph num="E."> <text>This reimbursement system is subject to the Administration's approved budget appropriation.</text> </paragraph> <paragraph num="F."> <text>This chapter does not affect any cost settlement or litigation related to funding commenced before July 1, 1998.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Add-on component” means one or more units of service, each one of which includes funding for direct service and other nondirect costs not covered by the sum of the provider and individual components.</text> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Agreement” means a legal document setting forth the rights and responsibilities of the Administration and the provider under the fee payment system.</text> </paragraph> <paragraph num="(4)"> <text>“Appropriate evaluation” means the assessment of an individual by a qualified developmental disability professional using accepted professional standards to document the presence of a:</text> <paragraph num="(a)"> <text>Developmental disability as defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Severe, chronic disability that qualifies the individual for support services as defined in Health-General Article, §7-403(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Attendance day” means, for:</text> <paragraph num="(a)"> <text>Day habilitation and vocational services, when the individual is present in the program for at least 4 hours a day during a regularly scheduled period of operation, with 6 to 8 hours per day as the service goal, and with Administration approval of fewer than 6 hours per day provided the individual plan indicates this lower level of service is necessary;</text> </paragraph> <paragraph num="(b)"> <text>Residential programs, as of October 1, 2001, when the individual is present for at least 6 hours in the home or spends the night in the home, which is the primary residence for the individual; and</text> </paragraph> <paragraph num="(c)"> <text>Supported employment, when the individual is engaged in supported employment for at least 4 hours a day, with 6 to 8 hours per day as the service goal, and with Administration approval of fewer than 6 hours per day provided the individual plan indicates this lower level of service is necessary.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Copayment” means that portion of the provider's charge for services for which the individual is responsible.</text> </paragraph> <paragraph num="(7)"> <text>“Cost report” means a document on a form approved by the Administration that details a provider's allowable operating expenses for a single fiscal year using prescribed cost centers.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Day habilitation” means services for individuals with developmental disabilities licensed under COMAR 10.22.07 and for purposes of COMAR 10.09.26 includes prevocational services.</text> </paragraph> <paragraph num="(10)"> <text>“Direct services” means staff services provided directly to the individual.</text> </paragraph> <paragraph num="(11)"> <text>“Existing service” means a service continuously provided to an individual by the same provider beginning on or before June 30, 1998.</text> </paragraph> <paragraph num="(12)"> <text>“Existing supported employment service” means a service provided continuously to an individual by the same provider beginning before July 1, 2001.</text> </paragraph> <paragraph num="(13)"> <text>“Fee payment system” means the system for rate setting and reimbursement for services provided by licensed residential, day habilitation, vocational, and supported employment programs.</text> </paragraph> <paragraph num="(14)"> <text>“Fiscal management services (FMS)” means a person approved by the Administration and designated as an Organized Health Care Delivery System under COMAR 10.22.20 that:</text> <paragraph num="(a)"> <text>Assists individuals and families in managing their funds and paying for services; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for submitting financial reports to the individual and Administration.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Funding level” means the total annual amount of money awarded by the Administration under the fee payment system or under a contract for a day habilitation, vocational, or residential program.</text> </paragraph> <paragraph num="(16)"> <text>“Individual” means a person who receives services funded by the Administration from a residential, day habilitation, vocational, or supported employment program.</text> </paragraph> <paragraph num="(17)"> <text>“Individual component” means one of the two parts of the rate that is based on an assessment of an individual's level of need as documented in the approved individual information form.</text> </paragraph> <paragraph num="(18)"> <text>“Individual indicator rating scale” means the instrument, approved by the Administration, to assess an individual's level of need.</text> </paragraph> <paragraph num="(19)"> <text>“Individual information form” means the form, approved by the Administration, used for documenting the results of an assessment using the individual indicator rating scale.</text> </paragraph> <paragraph num="(20)"> <text>“Individual plan (IP)” means the written plan of specific action that is developed and modified by an individual's team.</text> </paragraph> <paragraph num="(21)"> <text>“Individual's team” means:</text> <paragraph num="(a)"> <text>The individual;</text> </paragraph> <paragraph num="(b)"> <text>The individual's proponent;</text> </paragraph> <paragraph num="(c)"> <text>Representatives of the licensee;</text> </paragraph> <paragraph num="(d)"> <text>The resource coordinator; and</text> </paragraph> <paragraph num="(e)"> <text>Others the individual may choose to develop the IP.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“New individuals” means those individuals starting service with a new provider.</text> </paragraph> <paragraph num="(23)"> <text>“Personal needs allowance” means the amount per month that a provider must allow an individual to retain from their monthly income for personal needs.</text> </paragraph> <paragraph num="(24)"> <text>“Professional services” means services provided by an individual authorized to perform these services under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Provider” means a person that is licensed and funded by the Administration to provide services to individuals under COMAR 10.22.08 or 10.22.07.</text> </paragraph> <paragraph num="(26)"> <text>“Provider component” means one of two parts of the rate that reimburses providers for indirect expenses.</text> </paragraph> <paragraph num="(27)"> <text>“Rate” means the reimbursement amount for an attendance day of service.</text> </paragraph> <paragraph num="(28)"> <text>“Regional director” means the designee of the Director of the Administration who is responsible for the administration of services in an assigned area of the State.</text> </paragraph> <paragraph num="(29)"> <text>“Residential program” means services for individuals with developmental disabilities licensed under COMAR 10.22.08.</text> </paragraph> <paragraph num="(30)"> <text>“Self-directed services” means services, as approved by the Administration:</text> <paragraph num="(a)"> <text>That an individual arranges; and</text> </paragraph> <paragraph num="(b)"> <text>For which the individual reimburses the provider.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Service approval” means the Administration's written approval for an individual to receive services from a provider.</text> </paragraph> <paragraph num="(32)"> <text>“Supplemental security income (SSI)” means income paid to the aged, blind, or disabled under Title XVI of the Social Security Act.</text> </paragraph> <paragraph num="(33)"> <text>“Supplemental services” means preauthorized services that directly benefit the individual and are not covered by the rate.</text> </paragraph> <paragraph num="(34)"> <text>“Support broker” means a person employed by individuals and families, who have been determined eligible by the Administration, that helps them:</text> <paragraph num="(a)"> <text>Decide what services and supports are best for them; and</text> </paragraph> <paragraph num="(b)"> <text>Access and manage the chosen services and supports.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>Supported Employment.</text> <paragraph num="(a)"> <text>“Supported employment” means services licensed under COMAR 10.22.07 when the individual is employed outside of the individual's home.</text> </paragraph> <paragraph num="(b)"> <text>“Supported employment” includes volunteer work when the volunteer work is for job training and preparation.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>Unit of service means:</text> <paragraph num="(a)"> <text>For day habilitation, vocational and supported employment programs awake direct support services, 1 hour;</text> </paragraph> <paragraph num="(b)"> <text>For residential programs:</text> <paragraph num="(i)"> <text>For awake direct support services, 1hour;</text> </paragraph> <paragraph num="(ii)"> <text>A preauthorized unit of service available to the individual and identified in the approved service funding plan; or</text> </paragraph> <paragraph num="(iii)"> <text>For support services other than awake direct support services, the provider cost multiplied by the number of approved hours and divided by the rate; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For professional services, 1 hour.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Utilization review” means the examination of an individual indicator rating scale to ascertain if the service needs level is appropriate and to verify that the indicated level of service is being provided.</text> </paragraph> <paragraph num="(38)"> <text>“Vocational services” means services provided by a licensed provider under COMAR 10.22.07 that are provided outside of the individual's home and for purposes of COMAR 10.09.26 are part of habilitation services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General."> <paragraph num="A."> <text>The provider shall sign an agreement with the Administration.</text> </paragraph> <paragraph num="B."> <text>The rights of the Administration include but are not limited to the following:</text> <paragraph num="(1)"> <text>Approving the individuals to be served;</text> </paragraph> <paragraph num="(2)"> <text>Performing a utilization review of individual indicator rating scales; and</text> </paragraph> <paragraph num="(3)"> <text>Auditing provider operations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Personal Needs Allowance.</text> <paragraph num="(1)"> <text>On January 1, 2009, the Administration set the personal needs allowance at $299 per month for an individual.</text> </paragraph> <paragraph num="(2)"> <text>The Administration may increase this amount annually not to exceed the:</text> <paragraph num="(a)"> <text>Social Security Administration's cost-of-living increase to Supplemental Security Income; or</text> </paragraph> <paragraph num="(b)"> <text>Medically needy income level as set forth in COMAR 10.09.24.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Administration shall notify all licensees whenever any increase to the personal needs allowance takes effect.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure Requirements."> <text>To receive reimbursement under this chapter, a provider shall:</text> <paragraph num="A."> <text>Be licensed in accordance with Health-General Article, Title 7, Annotated Code of Maryland, and COMAR 10.22.08 or 10.22.07; and</text> </paragraph> <paragraph num="B."> <text>Comply with COMAR 10.09.26 and all other applicable regulations under COMAR 10.09.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reporting Requirements and Record Keeping."> <paragraph num="A."> <text>The provider shall submit an annual cost report not later than 6 months after the end of the State fiscal year that:</text> <paragraph num="(1)"> <text>Documents the provider's actual expenditures for the fiscal year being reported;</text> </paragraph> <paragraph num="(2)"> <text>Is based on the provider's audited financial statement;</text> </paragraph> <paragraph num="(3)"> <text>Includes a worksheet reconciling the cost report to the financial statement; and</text> </paragraph> <paragraph num="(4)"> <text>Contains a certification by an independent certified public accountant, who is not an employee of the licensee or any affiliated organization, for the:</text> <paragraph num="(a)"> <text>Individual copayments collected, and</text> </paragraph> <paragraph num="(b)"> <text>Actual attendance days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Maintain a record for each individual that includes but is not limited to the:</text> <paragraph num="(a)"> <text>Results of the individual indicator rating scale,</text> </paragraph> <paragraph num="(b)"> <text>Appropriate evaluation, with approval by the regional director responsible for the individual's service approval, and</text> </paragraph> <paragraph num="(c)"> <text>Individual plan that identifies the individual's service needs, signed and dated by the provider; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Report to the Administration regarding the individual's eligibility for Supplemental Security Income (SSI).</text> </paragraph> </paragraph> <paragraph num="C."> <text>The provider shall submit an annual wage and benefits survey in a format approved by the Administration by the later of 60 days after:</text> <paragraph num="(1)"> <text>The last day of the pay period for which the data is requested; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt of a request from the Administration for wage survey information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Administration may require a provider to complete other reports and furnish information relating to the provider and the cost of services in formats approved by the Administration.</text> </paragraph> <paragraph num="E."> <text>For reports and data required under this chapter, the Administration may, with notice, suspend payment of the provider component until the report or data is received.</text> </paragraph> <paragraph num="F."> <text>For the annual cost report and the annual wage and benefits survey, the Administration may, after notice and an opportunity to be heard, fiscally sanction providers as set forth in Health-General Article, §7-910(c), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Determination of Individual Component."> <paragraph num="A."> <text>The individual component is for costs the provider incurs in providing direct services to the individual.</text> </paragraph> <paragraph num="B."> <text>The Administration shall establish an individual component for new and existing services that is based on the:</text> <paragraph num="(1)"> <text>Individual indicator rating scale; and</text> </paragraph> <paragraph num="(2)"> <text>Geographic region in which the service is provided.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Individuals who have been receiving services from a provider and who are transferring to a different provider shall retain the individual component established by the Administration.</text> </paragraph> <paragraph num="D."> <text>Except as set forth in §C of this regulation, the following apply:</text> <paragraph num="(1)"> <text>The regional director shall establish a temporary individual component for each service the individual is to receive by taking the average of the individual components for all the individuals served by the provider in the service category;</text> </paragraph> <paragraph num="(2)"> <text>The provider shall forward the individual information form reflecting the results of the individual indicator rating scale assessment to the regional director within 35 days for approval;</text> </paragraph> <paragraph num="(3)"> <text>The Administration shall establish a permanent individual component within 6 months based on the approved individual indicator rating scale assessment; and</text> </paragraph> <paragraph num="(4)"> <text>The permanent individual component shall be retroactive to the date the individual entered service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The geographic regions are as follows:</text> <paragraph num="(1)"> <text>Region 1 represents Baltimore City, Baltimore County, Anne Arundel County, Harford County, Howard County, Carroll County, and Queen Anne's County;</text> </paragraph> <paragraph num="(2)"> <text>Region 2 represents Calvert County, Frederick County, Prince George's County, Montgomery County, and Charles County;</text> </paragraph> <paragraph num="(3)"> <text>Region 3 represents St. Mary's County, Garrett County, Caroline County, Dorchester County, Kent County, Somerset County, Talbot County, Wicomico County, and Worcester County;</text> </paragraph> <paragraph num="(4)"> <text>Region 4 represents Allegany County;</text> </paragraph> <paragraph num="(5)"> <text>Region 5 represents Cecil County; and</text> </paragraph> <paragraph num="(6)"> <text>Region 6 represents Washington County.</text> </paragraph> </paragraph> <paragraph num="F."> <text>For purposes of this regulation, levels 1—5 in supervision/assistance and levels 1—5 in health/medical in §G of this regulation represent levels of services needed by individuals as assessed by the individual indicator rating scale.</text> </paragraph> <paragraph num="G."> <text>Table of Individual Components Effective July 1, 2019.</text> <paragraph num="(1)"> <text>Residential Programs.</text> </paragraph> <paragraph num="(2)"> <text>Day Programs.</text> </paragraph> <paragraph num="(3)"> <text>Supported Employment Programs.</text> </paragraph> <paragraph num="(4)"> <text>Community Learning Services.</text> </paragraph> <paragraph num="(5)"> <text>Employment Discovery and Customization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Provider Components."> <text>Effective July 1, 2019 the provider components for all regions are as follows:</text> <paragraph num="A."> <text>The residential program provider component is $70.91; and</text> </paragraph> <paragraph num="B."> <text>The day habilitation, vocational, supported employment, community learning services, and employment discovery and customization program provider component is $39.26.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Add-On Component."> <paragraph num="A."> <text>An add-on component is for:</text> <paragraph num="(1)"> <text>Residential programs;</text> </paragraph> <paragraph num="(2)"> <text>Day habilitation, vocational, and supported employment programs; and</text> </paragraph> <paragraph num="(3)"> <text>Professional services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration may preauthorize and approve one or more units of add-on components for additional support:</text> <paragraph num="(1)"> <text>Not to exceed 1 year for individuals whose need for additional support is the result of a temporary condition; or</text> </paragraph> <paragraph num="(2)"> <text>Exceeding 1 year for individuals whose need for additional support is on-going.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The per-unit amounts have been calculated to cover all costs incidental to providing the service.</text> </paragraph> <paragraph num="D."> <text>In order to preauthorize and approve one or more units of add-on components for an individual, the Administration shall determine that the:</text> <paragraph num="(1)"> <text>Individual's particular circumstances warrant units of add-on components to implement the IP; and</text> </paragraph> <paragraph num="(2)"> <text>Individual requires more services than the provider can provide with the sum of the provider and individual components.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Circumstances that warrant units of add-on components include a need for:</text> <paragraph num="(1)"> <text>Additional support for an individual whose individual component is less than level 5 and for whom approval of an add-on component would be more cost effective than an increase in the individual component;</text> </paragraph> <paragraph num="(2)"> <text>Ongoing, intensive support, such as one-to-one support, for an individual whose individual component is level 5;</text> </paragraph> <paragraph num="(3)"> <text>Ongoing support in a residential program for an individual who does not attend day services;</text> </paragraph> <paragraph num="(4)"> <text>Awake-overnight support for an individual; and</text> </paragraph> <paragraph num="(5)"> <text>Professional services not covered by Medicaid or other payers.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures for Requesting Authorization of Add-On Components.</text> <paragraph num="(1)"> <text>On forms approved by the Administration, the provider shall submit documentation that justifies the request for add-on components.</text> </paragraph> <paragraph num="(2)"> <text>For all requests for add-on components, the justification shall include:</text> <paragraph num="(a)"> <text>Recommendations from the individual's team and appropriate professionals;</text> </paragraph> <paragraph num="(b)"> <text>Services the provider can provide with existing resources; and</text> </paragraph> <paragraph num="(c)"> <text>Any other information required by the Administration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For requests for professional add-on components, additional justification shall include:</text> <paragraph num="(a)"> <text>The individual's IP and any additional documentation the administration requires indicating the service is necessary; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation that:</text> <paragraph num="(i)"> <text>The individual is not eligible for Medical Assistance;</text> </paragraph> <paragraph num="(ii)"> <text>For individuals who are Medicaid eligible, the service sought is not a service covered by the Maryland Medical Assistance Program; or</text> </paragraph> <paragraph num="(iii)"> <text>If the individual is Medicaid eligible and the service is covered by the Maryland Medical Assistance Program, the Maryland Medical Assistance Program has denied coverage, and the agency is pursuing an appeal.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Administration Approval of Add-on Components.</text> <paragraph num="(1)"> <text>In deciding whether to preauthorize an add-on component, the Administration shall:</text> <paragraph num="(a)"> <text>Consider the documentation submitted by the provider in §F of this regulation that identifies the needs of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Consider the proposed cost for the add-on component;</text> </paragraph> <paragraph num="(c)"> <text>Consider the existing funding levels for other individuals at the service site and the availability of State funds;</text> </paragraph> <paragraph num="(d)"> <text>If appropriate, visit the individual in the setting where the service is to be provided; and</text> </paragraph> <paragraph num="(e)"> <text>Review the provider's efforts to meet the individual's needs with existing resources available at the site such as staffing levels and revenue for all services provided at the site.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When determining the number of units of add-on components to authorize, the Administration shall conduct the cost analysis described in §G(1) of this regulation. The Administration may authorize the number of units of add-on components necessary to fund the amount identified by the cost analysis.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Review of Add-on Components. Unless justification for a less frequent review is documented, the Administration shall review the appropriateness of the add-on component:</text> <paragraph num="(1)"> <text>For individuals receiving temporary additional support, quarterly for up to 1 year after which the Administration shall:</text> <paragraph num="(a)"> <text>Reassess the appropriateness of the individual component and increase the individual component if justified;</text> </paragraph> <paragraph num="(b)"> <text>Continue the temporary additional support for up to 1 year if the individual's prognosis indicates that the condition remains temporary; or</text> </paragraph> <paragraph num="(c)"> <text>Discontinue the temporary additional support; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For other individuals, quarterly during the first year and annually after that.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The add-on component is calculated by multiplying the number of units of service per week approved by the Administration by the per unit amount and dividing by seven for residential programs and by the number of approved days of service per week for day habilitation, vocational, and supported employment programs.</text> </paragraph> <paragraph num="J."> <text>Reimbursement for Add-On Components.</text> <paragraph num="(1)"> <text>Unless the Administration preauthorizes an add-on component, the Administration may not reimburse the provider.</text> </paragraph> <paragraph num="(2)"> <text>Effective July 1, 2019, the amount per unit of service for residential programs is as follows:</text> <paragraph num="(a)"> <text>In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $21.19;</text> </paragraph> <paragraph num="(b)"> <text>In Cecil County — $22.31; and</text> </paragraph> <paragraph num="(c)"> <text>In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $22.59.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Effective July 1 2019, the amount per unit of service for day habilitation and community learning services is as follows:</text> <paragraph num="(a)"> <text>In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $23.68;</text> </paragraph> <paragraph num="(b)"> <text>In Cecil County — $24.80; and</text> </paragraph> <paragraph num="(c)"> <text>In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $25.09.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Effective July 1 2019, the amount per unit of service for supported employment and employment discovery and customization is as follows:</text> <paragraph num="(a)"> <text>In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $23.68;</text> </paragraph> <paragraph num="(b)"> <text>In Cecil County — $24.80; and</text> </paragraph> <paragraph num="(c)"> <text>In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $25.09.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Effective July 1 2019, the amount per unit of service per individual for professional services is as follows:</text> <paragraph num="(a)"> <text>In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $34.93;</text> </paragraph> <paragraph num="(b)"> <text>In Cecil County — $36.89; and</text> </paragraph> <paragraph num="(c)"> <text>In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $37.39.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supplemental Services."> <paragraph num="A."> <text>The Administration may preauthorize supplemental services.</text> </paragraph> <paragraph num="B."> <text>Supplemental services do not include any services that are in the State Medical Assistance Plan and can be provided to an individual and reimbursed under the Medical Assistance Program, or any services covered by private insurance or federal and State funded health programs.</text> </paragraph> <paragraph num="C."> <text>Supplemental services include:</text> <paragraph num="(1)"> <text>Household furnishings and equipment, normally funded once per individual;</text> </paragraph> <paragraph num="(2)"> <text>Transportation equipment and expenses;</text> </paragraph> <paragraph num="(3)"> <text>Assistive technology;</text> </paragraph> <paragraph num="(4)"> <text>Medical equipment;</text> </paragraph> <paragraph num="(5)"> <text>Structural modifications for accessibility; and</text> </paragraph> <paragraph num="(6)"> <text>Other services as preauthorized by the Administration that directly benefit the individual.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Procedures for Requesting Authorization of Supplemental Services. On forms approved by the Administration, the provider shall submit documentation that justifies the:</text> <paragraph num="(1)"> <text>Request for supplemental services, and includes:</text> <paragraph num="(a)"> <text>Recommendations from the individual's team;</text> </paragraph> <paragraph num="(b)"> <text>Documentation from appropriate individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Any other information required by the Administration; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Basis of the proposed costs, such as:</text> <paragraph num="(a)"> <text>Bids from vendors;</text> </paragraph> <paragraph num="(b)"> <text>Advertisements or invoices from retail or wholesale outlets selling goods and services to the general public; and</text> </paragraph> <paragraph num="(c)"> <text>Rates of a proposed vendor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Administration Approval of Supplemental Services. In deciding whether to preauthorize a supplemental service, the Administration shall:</text> <paragraph num="(1)"> <text>Consider the documentation submitted by the provider in §D of this regulation that identifies the needs of the individual;</text> </paragraph> <paragraph num="(2)"> <text>Consider the proposed cost for the supplemental service and the availability of State funds;</text> </paragraph> <paragraph num="(3)"> <text>If appropriate, visit the individual in the setting where the service is to be provided; and</text> </paragraph> <paragraph num="(4)"> <text>Review the provider's efforts to meet the individual's needs with existing resources available at the site.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Payment for Services Reimbursed by Rates."> <paragraph num="A."> <text>The Department shall pay the provider the rate set forth under this chapter.</text> </paragraph> <paragraph num="B."> <text>The rate is the sum of the individual component, the provider component, and any add-on component.</text> </paragraph> <paragraph num="C."> <text>Reimbursement for Attendance Days of Day Habilitation, Vocational Services, and Supported Employment with Fewer than the Hours as Defined in Regulation .02 of this chapter.</text> <paragraph num="(1)"> <text>The Administration may:</text> <paragraph num="(a)"> <text>Not approve reimbursement for an attendance day if the individual receives fewer than 4 hours of service;</text> </paragraph> <paragraph num="(b)"> <text>Approve reimbursement for fewer hours than the normal attendance day if the IP:</text> <paragraph num="(i)"> <text>Documents that the individual is not able to engage in the program activities for the normal attendance day; and</text> </paragraph> <paragraph num="(ii)"> <text>Includes a plan for enabling the individual to be engaged in a normal attendance day; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Approve reimbursement for an attendance day of supported employment when the individual receives fewer than 4 hours of supported employment services if the:</text> <paragraph num="(i)"> <text>IP documents that the individual is not able to engage in supported employment activities for 4 hours a day;</text> </paragraph> <paragraph num="(ii)"> <text>IP includes a plan for enabling the individual to be engaged in supported employment for at least 4 hours with the goal being a normal attendance day; and</text> </paragraph> <paragraph num="(iii)"> <text>Individual is engaged in at least 4 hours of activity that may include day habilitation and vocational services, with the majority of time spent in supported employment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Administration's approval of electronic or paper attendance documentation as specified by the Administration and submitted by the provider shall constitute approval of an attendance day of fewer than 6 to 8 hours if the approved individual plan indicates this lower level of service is necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Conversion of Existing Supported Employment Services from a Contract to the Rate System.</text> <paragraph num="(1)"> <text>There is a presumption that the cost of care for existing supported employment services reimbursed by the Administration under the rate system will be the same as under the contract.</text> </paragraph> <paragraph num="(2)"> <text>The Administration shall reimburse the provider at least the same amount for cost of care for existing supported employment services as the Administration reimbursed the provider under the contract.</text> </paragraph> <paragraph num="(3)"> <text>The Administration shall convert the contract reimbursement for individuals into a base rate together, if appropriate, with add-on components.</text> </paragraph> <paragraph num="(4)"> <text>If a utilization review audit indicates that add-on components were not required for the individual, the Administration may recover unnecessary expenditures.</text> </paragraph> <paragraph num="(5)"> <text>A provider may request additional services as set forth in Regulation .08F of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>The Administration shall review any add-on components for existing services every 3 years unless the Administration documents a need for more frequent review.</text> </paragraph> <paragraph num="(7)"> <text>The Department shall reimburse providers of existing supported employment services by converting those contracts to reimbursement under this chapter between June 30, 2001, and July 1, 2002.</text> </paragraph> </paragraph> <paragraph num="E."> <text>For add-on components, the Department shall reimburse providers of existing augmentation services by converting those contracts to reimbursement under this chapter between June 30, 2001, and July 1, 2003.</text> </paragraph> <paragraph num="F."> <text>For a single calendar day, the Administration may not reimburse a provider for two or more attendance days of any combination of:</text> <paragraph num="(1)"> <text>Residential services under this chapter, community supported living arrangements under COMAR 10.22.18, and personal care services under COMAR 10.09.20; or</text> </paragraph> <paragraph num="(2)"> <text>Day habilitation services under this chapter, supported employment services under this chapter, vocational services under this chapter, and medical day care services under COMAR 10.09.07.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Absences and Vacancies.</text> <paragraph num="(1)"> <text>As of July 1, 2011, the Department shall only reimburse providers for 33 days of absences or vacancies per year per individual when the individual is unable to be in residential services due to illness, vacation, home visits, medical appointments, or other circumstances.</text> </paragraph> <paragraph num="(2)"> <text>As of July 1, 2003, the Department may claim federal financial participation for residential absence days as permitted by the Centers for Medicare and Medicaid Services under the Home and Community-Based Waiver.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Administration shall reimburse day and supported employment programs an additional $2,000 per year per individual for transportation to and from day habilitation and vocational programs or to and from supported employment for individuals who, because of their disabilities, must use wheelchairs or motorized scooters, if the payments are consistent with the requirements under COMAR 10.09.26 and 10.09.19.</text> </paragraph> <paragraph num="I."> <text>For residential services only, the Administration shall subtract from the payment, as appropriate, SSI contributions by individuals or other copayments.</text> </paragraph> <paragraph num="J."> <text>The provider shall:</text> <paragraph num="(1)"> <text>Assist the individual in obtaining SSI, if applicable; and</text> </paragraph> <paragraph num="(2)"> <text>Collect all applicable individual copayment obligations while assuring that the individual retains the personal needs allowance.</text> </paragraph> </paragraph> <paragraph num="K."> <text>To be reimbursed under this chapter, the provider shall submit:</text> <paragraph num="(1)"> <text>Attendance data for individuals served; and</text> </paragraph> <paragraph num="(2)"> <text>Other information as required by the Administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Payment For Supplemental Services."> <paragraph num="A."> <text>The Administration shall pay the lower of either:</text> <paragraph num="(1)"> <text>Reasonable customary and actual costs not to exceed the cost to the general public; or</text> </paragraph> <paragraph num="(2)"> <text>Medicaid-approved rates.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reasonable customary and actual costs are determined and authorized by the Administration before the delivery of the service.</text> </paragraph> <paragraph num="C."> <text>The Department shall reimburse the providers for preauthorized supplemental services upon submission of an invoice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Contract."> <paragraph num="A."> <text>If the Department preauthorizes a professional service, the Administration shall reimburse the provider for professional services according to the rate schedule in Regulation .08J(4) of this chapter except that the Administration may procure services to be reimbursed at a higher rate if:</text> <paragraph num="(1)"> <text>The provider submits documentation that it cannot find a professional to render services at this rate;</text> </paragraph> <paragraph num="(2)"> <text>The usual and customary rate charged by the professional for the service is above the rate in Regulation .08J(4) of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>The rate that the Maryland Medical Assistance Program reimburses the professional for this service is higher than the rate established by Regulation .08J(4) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration may procure services needed by an individual as documented in the IP and preauthorized but not covered by rates or supplemental services in accordance with the State's requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Rates for Self-Directed Services."> <paragraph num="A."> <text>If there is an existing contract to buy vocational and supported employment services, the contract amount less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing supported employment services and support brokerage services in an individual's budget.</text> </paragraph> <paragraph num="B."> <text>If there is no existing contract to buy vocational and supported employment services, the supported employment rates less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing supported employment services and support brokerage services in an individual's budget.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Hearings."> <text>If an individual is denied services, the individual may request a hearing in accordance with all applicable federal and State laws and regulations, including COMAR 10.09.24.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Phase-In of Provider Component."> <paragraph num="A."> <text>The Administration shall phase in the provider component for existing services.</text> </paragraph> <paragraph num="B."> <text>The Administration shall determine providers' increases and decreases as described in this regulation.</text> </paragraph> <paragraph num="C."> <text>The individual components and the day habilitation and vocational program provider component in Regulations .06 and .07 of this chapter include increases funded by allocations in the fiscal year 1999 budget. The Administration shall calculate the phase-in of provider components before adding these increases to the rate.</text> </paragraph> <paragraph num="D."> <text>Until the rate reaches the rate in Regulation .07 of this chapter, the phase-in for providers with current provider components higher than that stated in Regulation .07 of this chapter shall be calculated as follows:</text> <paragraph num="(1)"> <text>Each provider's provider component for existing services given after June 30, 1998, shall be adjusted to reflect not more than a 3 percent decrease in the provider's July 1, 1997, funding level;</text> </paragraph> <paragraph num="(2)"> <text>Each provider's provider component for existing services given after June 30, 1999, shall be adjusted to reflect not more than a 7 percent decrease in the provider's July 1, 1997, funding level;</text> </paragraph> <paragraph num="(3)"> <text>Each provider's provider component for existing services given after June 30, 2000, shall be adjusted to reflect not more than a 12 percent decrease in the provider's July 1, 1997, funding level; and</text> </paragraph> <paragraph num="(4)"> <text>Beginning July 1, 2001, the provider component for all existing services is the provider component stated in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Until the rate reaches the rate in Regulation .07 of this chapter, the phase-in for providers with current provider components lower than that stated in Regulation .07 of this chapter shall be calculated within the allocated budget for these services as follows:</text> <paragraph num="(1)"> <text>Each provider's provider component for existing services given after June 30, 1998, shall be adjusted to reflect at least a 2.5 percent increase in the provider's July 1, 1997, funding level;</text> </paragraph> <paragraph num="(2)"> <text>Each provider's provider component for existing services given after June 30, 1999, shall be adjusted to reflect at least a 5 percent increase in the provider's July 1, 1997, funding level;</text> </paragraph> <paragraph num="(3)"> <text>Each provider's provider component for existing services given after June 30, 2000, shall be adjusted to reflect at least a 7.5 percent increase in the provider's July 1, 1997, funding level; and</text> </paragraph> <paragraph num="(4)"> <text>Beginning July 1, 2001, the provider component for all existing services is the provider component stated in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The provider component for new services or changes in services for any individual after April 30, 1998, is the provider component stated in Regulation .07 of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7-306.1, 7-307, 7-910(c), 15-105, 15-107, and 16-201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 10, 1987 (14:16 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03, .06, and .08 amended as an emergency provision effective October 16, 1995 (22:22 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F repealed effective June 21, 1993 (20:12 Md. R. 997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C adopted effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D adopted as an emergency provision effective July 11, 1996 (23:16 Md. R. 1167); emergency status extended at 24:2 Md. R. 113; emergency status expired June 30, 1997</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed and new chapter adopted effective July 1, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended as an emergency provision effective June 29, 1999 (26:15 Md. R. 1145); amended permanently effective October 4, 1999 (26:20 Md. R. 1545)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective July 1, 2001 (28:15 Md. R. 1394); revised permanently effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 30, 2002 (29:19 Md. R. 1524)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 13, 2006 (33:5 Md. R. 520); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective August 12, 2021 (48:19 Md. R. 798); emergency status expired December 31, 2021</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 20, 2022 (49:4 Md. R. 296); emergency status expired effective March 31, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective May 27, 2022 (49:13 Md. R. 686); emergency status expired effective June 30, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective February 2, 2023 (50:4 Md. R. 120); emergency status expired effective August 1, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G repealed and new regulation.06G adopted as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); adopted permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08J amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective August 12, 2021 (48:19 Md. R. 798); emergency status expired December 31, 2021</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective January 20, 2022 (49:4 Md. R. 296); emergency status expired effective March 31, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective May 27, 2022 (49:13 Md. R. 686); emergency status expired June 30, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective February 2, 2023 (50:4 Md. R. 120); emergency status expired effective August 1, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended as an emergency provision effective April 8, 2004 (31:9 Md. R. 711); amended permanently effective August 2, 2004 (31:15 Md. R. 1185)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulations .13 and .14 recodified to be Regulations .14 and .15 respectively, and new Regulation .13 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> </annotations> </chapter> <chapter num="18" heading="Community Supported Living Arrangements Payment System"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes the methodology by which the Department shall reimburse licensed Community Supported Living Arrangements providers for:</text> <paragraph num="(1)"> <text>Services, the provision of which begins after June 30, 2000; and</text> </paragraph> <paragraph num="(2)"> <text>Existing services provided under contract which the Department shall convert to this rate system.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The rates are based on the service needs of the individual and an allowance for indirect expenses incurred by licensees.</text> </paragraph> <paragraph num="C."> <text>Reimbursement for supplemental services are for services not covered by the rates.</text> </paragraph> <paragraph num="D."> <text>Services reimbursed by the Community Supported Living Arrangements payment system established by this chapter are paid for by Medicaid funds or, in whole or in part, by State general funds.</text> </paragraph> <paragraph num="E."> <text>This chapter does not limit the Administration's ability to contract for other services or additional services according to State procurement laws and as set forth in this chapter.</text> </paragraph> <paragraph num="F."> <text>The Community Supported Living Arrangements payment system is subject to the budget appropriation approved by the General Assembly.</text> </paragraph> <paragraph num="G."> <text>The Administration pays for the most effective service at the most efficient cost.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Actual costs” means all direct and indirect costs that the provider incurs for labor performed or goods delivered.</text> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Base services” means services covered by the rate.</text> </paragraph> <paragraph num="(4)"> <text>“Community Supported Living Arrangements (CSLA)” has the meaning stated in COMAR 10.22.01.01B(12).</text> </paragraph> <paragraph num="(5)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(6)"> <text>“Direct services” means services provided directly to the individual.</text> </paragraph> <paragraph num="(7)"> <text>“Existing services” means a service provided continuously to an individual by the same provider beginning on or before June 30, 2000.</text> </paragraph> <paragraph num="(8)"> <text>“Fiscal management services (FMS)” means a person approved by the Administration and designated as an Organized Health Care Delivery System under COMAR 10.22.20 that:</text> <paragraph num="(a)"> <text>Assists individuals and families in managing their funds and paying for services; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for submitting financial reports to the individual and Administration.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Hours of service” means the preauthorized hours of direct services made available to the individual being served as identified in the individual plan.</text> </paragraph> <paragraph num="(10)"> <text>“Individual plan (IP)” has the meaning stated in COMAR 10.22.01.01B(27).</text> </paragraph> <paragraph num="(11)"> <text>“Licensee” means a provider of Community Supported Living Arrangement services licensed under COMAR 10.22.02.01A.</text> </paragraph> <paragraph num="(12)"> <text>“New individuals” means those individuals starting Community Supported Living Arrangements services with a licensee after June 30, 2000.</text> </paragraph> <paragraph num="(13)"> <text>Professional Services.</text> <paragraph num="(a)"> <text>“Professional services” means services provided by an individual authorized to perform these services under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Professional services” includes but is not limited to direct, on- going nursing services and behavioral services provided in accordance with COMAR 10.22.10.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Rate” means the amount the Department pays for an hour of CSLA service and covers all actual costs incidental to providing the service, including but not limited to coordination of the service; nursing review of services; administrative costs; staff hiring, training, travel, and supervision; and program direction. The hours of service are used to determine the rate.</text> </paragraph> <paragraph num="(15)"> <text>“Self-directed services” means services, as approved by the Administration:</text> <paragraph num="(a)"> <text>That an individual arranges; and</text> </paragraph> <paragraph num="(b)"> <text>For which the individual reimburses the provider.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Supplemental services” means preauthorized services not covered by the rate.</text> </paragraph> <paragraph num="(17)"> <text>“Support broker” means a person employed by individuals and families, who have been determined eligible by the Administration, that helps them:</text> <paragraph num="(a)"> <text>Decide what services and supports are best for them; and</text> </paragraph> <paragraph num="(b)"> <text>Access and manage the chosen services and supports.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Requirements."> <paragraph num="A."> <text>To provide CSLA services and seek reimbursement from the Administration, a licensee shall:</text> <paragraph num="(1)"> <text>Be licensed in accordance with Health-General Article, Title 7, Annotated Code of Maryland, and COMAR 10.22.02;</text> </paragraph> <paragraph num="(2)"> <text>Comply with:</text> <paragraph num="(a)"> <text>COMAR 10.22.08; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.09.26;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Execute an agreement with the Administration;</text> </paragraph> <paragraph num="(4)"> <text>Comply with the Administration's reporting and record-keeping requirements, including:</text> <paragraph num="(a)"> <text>Submitting an annual cost report on a form approved by the Administration not later than 6 months after the end of the State fiscal year that:</text> <paragraph num="(i)"> <text>Documents the licensee's actual expenditures for the fiscal year being reported;</text> </paragraph> <paragraph num="(ii)"> <text>Is based on the licensee's audited financial statement;</text> </paragraph> <paragraph num="(iii)"> <text>Includes a work sheet reconciling the cost report to the financial statement; and</text> </paragraph> <paragraph num="(iv)"> <text>Is certified by an independent certified public accountant, who is not an employee of the licensee or any affiliated organization, for the actual days each individual received services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Retaining documentation of the costs for supplemental services for at least 6 years after the expenses are incurred; and</text> </paragraph> <paragraph num="(c)"> <text>Submitting an annual wage and benefits survey in a format approved by the Administration by the later of 60 days after:</text> <paragraph num="(i)"> <text>The last day of the pay period for which the data is requested; or</text> </paragraph> <paragraph num="(ii)"> <text>Receipt of a request from the Administration for wage survey information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Submit to the Administration for its approval the number of hours of service an individual needs per week, as documented by the individual's IP, on a form specified by the Administration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For reports and data required under this chapter, the Administration may, with notice, suspend payment of 25 percent of the provider's per diem rate until the report or data is received.</text> </paragraph> <paragraph num="C."> <text>For the annual cost report and the annual wage and benefits survey, the Administration may, after notice and an opportunity to be heard, fiscally sanction providers as set forth in Health-General Article, §7-910(c), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Rates."> <paragraph num="A."> <text>The Department shall reimburse the licensee:</text> <paragraph num="(1)"> <text>For new individuals served after June 30, 2000, according to the rates set forth in this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>For individuals receiving existing services, by converting those contracts to the Community Supported Living Arrangements Payment System if appropriate between:</text> <paragraph num="(a)"> <text>July 1, 2000, and December 31, 2000, if the individuals are living in their own residences, and</text> </paragraph> <paragraph num="(b)"> <text>January 1, 2001, and June 30, 2001, if the individuals are living with their families.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Administration determines the rate based on the number of preauthorized hours of service each individual needs each week as documented by the individual's IP.</text> </paragraph> <paragraph num="C."> <text>If an individual does not need the same amount of services each week, the rate is determined by the number of preauthorized hours of service in a 4-week period divided by 4, and is at least 1 hour each week.</text> </paragraph> <paragraph num="D."> <text>The Department shall pay a daily amount per individual calculated by multiplying the number of hours of service each week approved for the individual by the hourly rate and dividing by seven.</text> </paragraph> <paragraph num="E."> <text>The basic rates for CSLA services are set forth in §I of this regulation. These rates do not include professional services.</text> </paragraph> <paragraph num="F."> <text>Under the rates, the Department may pay for up to 82 hours of service each week.</text> </paragraph> <paragraph num="G."> <text>If awake-overnight or one-to-one services are indicated in the individual's IP, and are not included in the 82 hours of base rate service, the Administration may:</text> <paragraph num="(1)"> <text>Preauthorize and approve additional hours of service beyond 82 hours after reviewing the IP and any additional documentation the Administration requests; and</text> </paragraph> <paragraph num="(2)"> <text>Reimburse the licensee as set forth in §J of this regulation for these services.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Professional Services.</text> <paragraph num="(1)"> <text>The Administration may preauthorize and approve professional services if:</text> <paragraph num="(a)"> <text>The individual's IP, and any additional documentation the administration requires indicates the service is necessary; and</text> </paragraph> <paragraph num="(b)"> <text>The provider submits documentation that:</text> <paragraph num="(i)"> <text>The individual is not eligible for medical assistance,</text> </paragraph> <paragraph num="(ii)"> <text>For individuals who are Medicaid eligible, the service sought is not a service covered by the Maryland Medical Assistance Program, or</text> </paragraph> <paragraph num="(iii)"> <text>If the individual is Medicaid eligible and the service is covered by the Maryland Medical Assistance Program, the provider submits documentation that the Maryland Medical Assistance Program has denied coverage, and the agency is pursuing an appeal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Administration approves and preauthorizes a professional service, the Administration shall reimburse the provider for professional services according to the rate schedule in §K of this regulation except that the Administration may procure services to be reimbursed at a higher rate if:</text> <paragraph num="(a)"> <text>The provider submits documentation that it cannot find a professional to render services at this rate;</text> </paragraph> <paragraph num="(b)"> <text>The usual and customary rate charged by the professional for the service is above the rate of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>The rate that the Maryland Medical Assistance Program reimburses the professional for this service is higher than the rate established by §K of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Fiscal Year 2020 Tables for CSLA’s Personal Supports Hourly Rates.</text> <paragraph num="(1)"> <text>State Fiscal Year 2019 CSLA’s Personal Supports Rates: Table for One Individual in a Dwelling Receiving CSLA Services.</text> </paragraph> <paragraph num="(2)"> <text>State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Two Individuals in a Dwelling Receiving CSLA Services.</text> </paragraph> <paragraph num="(3)"> <text>State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Three Individuals in a Dwelling Receiving CSLA Services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for 1:1 Support or Not More than 8 Hours of Awake-Overnight Support per Residence for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling.</text> </paragraph> <paragraph num="K."> <text>State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Professional Services for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Supplemental Services."> <paragraph num="A."> <text>Supplemental services do not include any services that are in the Maryland Medical Assistance Program and can be provided to an individual and reimbursed under the Medical Assistance Program, or any services covered by private insurance, including Medicare.</text> </paragraph> <paragraph num="B."> <text>Supplemental services include:</text> <paragraph num="(1)"> <text>Respite;</text> </paragraph> <paragraph num="(2)"> <text>Expenses related to the operation and maintenance of the individual's vehicle;</text> </paragraph> <paragraph num="(3)"> <text>Medical equipment;</text> </paragraph> <paragraph num="(4)"> <text>Structural modifications for accessibility;</text> </paragraph> <paragraph num="(5)"> <text>Habitation start-up;</text> </paragraph> <paragraph num="(6)"> <text>Assistive technology;</text> </paragraph> <paragraph num="(7)"> <text>Other services as preauthorized and approved by the Administration; and</text> </paragraph> <paragraph num="(8)"> <text>Housing costs, if:</text> <paragraph num="(a)"> <text>The individual is unable to pay the full amount of ongoing housing costs, and</text> </paragraph> <paragraph num="(b)"> <text>There are no other State or federal resources available to pay for the ongoing housing costs.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Requests For and Approval of Supplemental Services."> <paragraph num="A."> <text>In order for the Administration to reimburse a licensee for supplemental services, the Administration shall preauthorize the service and approve the cost.</text> </paragraph> <paragraph num="B."> <text>To be approved for reimbursement of supplemental services, except housing, the licensee shall:</text> <paragraph num="(1)"> <text>Submit a written request to the Administration justifying the request, including:</text> <paragraph num="(a)"> <text>Recommendations from the individual's team,</text> </paragraph> <paragraph num="(b)"> <text>Documentation from appropriate professionals, and</text> </paragraph> <paragraph num="(c)"> <text>Other documentation the Administration requires; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Justify the basis of the proposed costs and submit supporting documentation, such as:</text> <paragraph num="(a)"> <text>Bids from vendors,</text> </paragraph> <paragraph num="(b)"> <text>Advertisements for the item, and</text> </paragraph> <paragraph num="(c)"> <text>Rates of a proposed vendor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To be approved for reimbursement of supplemental housing costs, the licensee shall submit a written request to the Administration documenting:</text> <paragraph num="(1)"> <text>The individual's income and expenses;</text> </paragraph> <paragraph num="(2)"> <text>The housing costs; and</text> </paragraph> <paragraph num="(3)"> <text>Efforts to obtain other State or federal assistance with housing costs.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In deciding whether to authorize supplemental services, the Administration shall:</text> <paragraph num="(1)"> <text>Consider the documentation submitted by the provider in this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Consider the proposed cost for the service;</text> </paragraph> <paragraph num="(3)"> <text>If appropriate, visit the individual in the setting where the continuous supplemental services are to be provided; and</text> </paragraph> <paragraph num="(4)"> <text>Review the licensee's efforts to meet the individual's needs within existing resources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment for Base Services."> <text>The licensee shall submit invoices or electronic claims in the form determined by the Administration.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment For Supplemental Services."> <paragraph num="A."> <text>The Administration shall pay the lower of either:</text> <paragraph num="(1)"> <text>Reasonable customary and actual costs not to exceed the cost to the general public; or</text> </paragraph> <paragraph num="(2)"> <text>Medicaid-approved rates.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reasonable customary and actual costs are determined and authorized by the Administration before the delivery of the service.</text> </paragraph> <paragraph num="C."> <text>The Department shall reimburse the licensee for preauthorized supplemental services upon submission of an invoice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Contract."> <text>The Administration shall contract for services needed by an individual as documented in the IP and preauthorized but not covered by rates or supplemental services in accordance with the State's procurement requirements.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Rates for Self-Directed Services."> <paragraph num="A."> <text>If there is an existing contract for family support services or individual support services, the contract amount less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing support services and support brokerage services in an individual's budget.</text> </paragraph> <paragraph num="B."> <text>If there is no existing contract for family support services or individual support services, the CSLA rates less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing support services and support brokerage services in an individual's budget.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7-306.1, 7-307, 7-714, 7-910(c), 15-105, 15-107, and 16-201, Annotated Code of Maryland; Ch. 102, Acts of 2001</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); adopted permanently effective October 30, 2000 (27:21 Md. R. 1976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 13, 2006 (33:5 Md. R. 520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1333)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1333)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04I, J, K amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); December 7, 2006 (33:24 Md. R. 1906); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:6 Md. R. 491); October 4, 2010 (37:20 Md. R. 1394); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective March 13, 2006 (33:5 Md. R. 520)</annotation> </annotations> </chapter> <chapter num="19" heading="Special Programs"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Day services” means services provided by a licensed provider under COMAR 10.22.07.03E.</text> </paragraph> <paragraph num="(2)"> <text>“Enclave” means a group of eight or fewer individuals with developmental disabilities that works as a single team in a single community work site.</text> </paragraph> <paragraph num="(3)"> <text>“Fiscal Incentive Program for Employment (FIPE)” means the program that provides a one-time fiscal incentive to eligible programs to assist individuals with developmental disabilities in securing and maintaining a job of the individual's choice in the community.</text> </paragraph> <paragraph num="(4)"> <text>“Mobile crew” means a group of eight or fewer individuals with developmental disabilities that operates as a single team moving from one work site to another, performing contracted tasks such as custodial and ground maintenance.</text> </paragraph> <paragraph num="(5)"> <text>“Self-employed” means an individual who owns and operates a business that generates revenue.</text> </paragraph> <paragraph num="(6)"> <text>“Sheltered environment” means a setting that is segregated to include only individuals with disabilities who perform work or simulated work training activities for subminimum wages.</text> </paragraph> <paragraph num="(7)"> <text>“Supported employment” has the meaning stated in COMAR 10.22.07.03C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fiscal Incentive Program for Employment."> <paragraph num="A."> <text>Provider Eligibility. A provider is eligible to be included in the FIPE if the provider:</text> <paragraph num="(1)"> <text>Is licensed as a vocational or day services program under COMAR 10.22.07; and</text> </paragraph> <paragraph num="(2)"> <text>Provides services to an eligible individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Individual Eligibility. An individual is eligible to be included in the FIPE if the individual:</text> <paragraph num="(1)"> <text>Has a developmental disability;</text> </paragraph> <paragraph num="(2)"> <text>Has not received a day service funded by the Administration before July 1, 2003;</text> </paragraph> <paragraph num="(3)"> <text>Is employed in the same job for 6 months which commenced on or after July 1, 2003, or if the individual was employed before entering DDA supported employment services, the 6 months of employment at the same job begins on the day in which the individual begins services, which is on or after July 1, 2003;</text> </paragraph> <paragraph num="(4)"> <text>Is receiving ongoing supports and services that are individually determined in order to attain and maintain a job of the individual's choice; and</text> </paragraph> <paragraph num="(5)"> <text>Has not been previously included in the FIPE.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Employment Eligibility. A job is an eligible job under the FIPE if:</text> <paragraph num="(1)"> <text>The job is:</text> <paragraph num="(a)"> <text>Located in the community;</text> </paragraph> <paragraph num="(b)"> <text>Individualized;</text> </paragraph> <paragraph num="(c)"> <text>Not an enclave, mobile crew, or in a segregated environment; and</text> </paragraph> <paragraph num="(d)"> <text>Based on the individual's interests; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual:</text> <paragraph num="(a)"> <text>Is paid a competitive salary and, if available, offered benefits directly by the employer;</text> </paragraph> <paragraph num="(b)"> <text>Does not receive salary and, if available, benefits from the provider or any organization affiliated with the licensee;</text> </paragraph> <paragraph num="(c)"> <text>Deals directly with the employer regarding working conditions such as work schedule;</text> </paragraph> <paragraph num="(d)"> <text>Has the opportunity for increased responsibility, career advancement, and increased wages based on performance; and</text> </paragraph> <paragraph num="(e)"> <text>If self-employed, the business generates revenue.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>If the provider wishes to seek reimbursement through the FIPE, the provider shall:</text> <paragraph num="(a)"> <text>Complete the application form provided by the Administration;</text> </paragraph> <paragraph num="(b)"> <text>Provide:</text> <paragraph num="(i)"> <text>Pay stubs for the last 6 months showing that an individual was employed in the community, as requested by the Administration; or</text> </paragraph> <paragraph num="(ii)"> <text>If the individual is self-employed, cash flow or other financial statements for the last 6 months;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide evidence that ongoing supports and services that are individually determined in order to maintain the job of the individual's choice have been provided;</text> </paragraph> <paragraph num="(d)"> <text>Provide a written statement from the individual or the individual's proponent indicating that the individual is satisfied with the current job and working conditions, including pay, work schedule, and benefits; and</text> </paragraph> <paragraph num="(e)"> <text>Provide any other information required by the Administration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Administration Approval. In deciding whether to authorize an individual for inclusion in the FIPE, the Administration shall consider the:</text> <paragraph num="(1)"> <text>Application and supporting documentation; and</text> </paragraph> <paragraph num="(2)"> <text>Availability of State funds.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payment.</text> <paragraph num="(1)"> <text>For each preauthorized and eligible individual, the Administration may approve a payment to the provider in the amount of 10 percent of the individual's annual funding, excluding add-on components and supplemental services, for the year the individual entered the FIPE.</text> </paragraph> <paragraph num="(2)"> <text>The Administration shall approve only one payment for each preauthorized and eligible individual.</text> </paragraph> <paragraph num="(3)"> <text>The provider shall submit an invoice to the Administration to receive payment.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 7-306.1, and 7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2003 (30:25 Md. R. 1846)</annotation> </annotations> </chapter> <chapter num="20" heading="Organized Health Care Delivery Systems"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to set forth the designation process and requirements for Organized Health Care Delivery Systems (OHCDS). Entities with this designation may subcontract with Medicaid and Non-Medicaid providers to allow individuals to receive services approved in their Individual Plans in the manner which best suits their needs and results in the more complete fulfillment of their plans.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter establishes the:</text> <paragraph num="A."> <text>Methodology that the Department shall use in the designation of entities as Organized Health Care Delivery Systems; and</text> </paragraph> <paragraph num="B."> <text>Requirements to be fulfilled by Organized Health Care Delivery Systems.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Regulatory Compliance."> <text>In addition to this chapter, a person who becomes an Organized Health Care Delivery System shall comply with the following regulations, as applicable:</text> <paragraph num="A."> <text>COMAR 10.22.01 — .10;</text> </paragraph> <paragraph num="B."> <text>COMAR 10.22.17;</text> </paragraph> <paragraph num="C."> <text>COMAR 10.22.18; and</text> </paragraph> <paragraph num="D."> <text>COMAR 10.09.26.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Definitions."> <paragraph num="A."> <text>In addition to the definitions set forth in COMAR 10.22.01, in this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Developmental Disabilities Administration.</text> </paragraph> <paragraph num="(2)"> <text>“Organized Health Care Delivery System (OHCDS)” means, under 42 CFR §447.10, a public or private organization for delivering health services that provides at least one Medicaid service directly and utilizes its own employees rather than contractors.</text> </paragraph> <paragraph num="(3)"> <text>“Provider entity” means the OHCDS or potential OHCDS.</text> </paragraph> <paragraph num="(4)"> <text>“Provider of service” means the person who actually delivers the service to the consumer.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Designation as an OHCDS."> <text>The Administration shall designate a provider who applies to be an OHCDS if the provider entity:</text> <paragraph num="A."> <text>Submits an application on a form approved by the Administration;</text> </paragraph> <paragraph num="B."> <text>Is licensed by the Administration to provide one of the following services:</text> <paragraph num="(1)"> <text>Community supported living arrangements;</text> </paragraph> <paragraph num="(2)"> <text>Family and individual support services;</text> </paragraph> <paragraph num="(3)"> <text>Day services;</text> </paragraph> <paragraph num="(4)"> <text>Supported employment services;</text> </paragraph> <paragraph num="(5)"> <text>Residential services; and</text> </paragraph> <paragraph num="(6)"> <text>Other services as applicable;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Is a Medicaid enrolled provider and renders at least one Medicaid Service directly; and</text> </paragraph> <paragraph num="D."> <text>Meets the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="OHCDS Requirements."> <text>An OHCDS may either provide services itself or subcontract with another entity, and shall:</text> <paragraph num="A."> <text>Ensure that services provided are consistent with the consumer's Individual Plan and are detailed in the payment agreement with the Administration;</text> </paragraph> <paragraph num="B."> <text>Submit reports and comply with record keeping in accordance with Health-General Article, §§7-306.1 and 7-910, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>Submit claims for Federal Financial Participation monthly or on an alternative time frame established by the Administration of which 50 percent of the OHCDS' quarterly payment may be withheld if required paperwork is not submitted within the designated time frame.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="OHCDS Subcontracting Requirements."> <text>When subcontracting, the OHCDS shall:</text> <paragraph num="A."> <text>Ensure that the providers of service meet all applicable provider qualifications set forth in COMAR 10.22 and 10.09.26, and any applicable industry or regulatory standards;</text> </paragraph> <paragraph num="B."> <text>Enter into a subcontract with each provider of service that:</text> <paragraph num="(1)"> <text>Contains the scope, frequency, duration, and cost of the services to be provided;</text> </paragraph> <paragraph num="(2)"> <text>Documents the qualifications of the provider of service;</text> </paragraph> <paragraph num="(3)"> <text>Details service termination procedures;</text> </paragraph> <paragraph num="(4)"> <text>Is consistent with the Individual's Plan; and</text> </paragraph> <paragraph num="(5)"> <text>Is executed by the individual, the service provider, and the OHCDS; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Maintain detailed records, to be available to the Administration, its designee, or the respective consumer for review at any time, on the purchase of services from qualified entities or individuals, including invoices.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Freedom of Choice of Providers."> <text>This chapter does not infringe on an individual's right to choose freely among qualified providers at any time.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Termination of Designation."> <text>The Administration may terminate OHCDS designation as set forth in COMAR 10.22.03.06 and 10.22.03.07.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §7-904, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 adopted as an emergency provision effective June 1, 2004 (31:16 Md. R. 1252); adopted permanently effective September 27, 2004 (31:19 Md. R. 1432)</annotation> </annotations> </chapter> </subtitle> <subtitle num="23" heading="Advance Directive Registry"> <chapter num="01" heading="Advance Directive Registry"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines key terms and sets out requirements and procedures for an Advance Directive Registry.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Advance Directive.</text> <paragraph num="(a)"> <text>“Advance directive” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Advance directive” includes an Instructions on Current Life-Sustaining Treatment Options form developed under Health-General Article, §5-608.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Authorized person” means an individual:</text> <paragraph num="(a)"> <text>Designated in writing by a registrant; or</text> </paragraph> <paragraph num="(b)"> <text>Under the conditions specified in federal or State law, authorized to obtain access to the medical records of the registrant.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Filing” means the presentation of an advance directive for registration to the Secretary.</text> </paragraph> <paragraph num="(5)"> <text>“Health care facility” has the meaning stated in Health-General Article, §19-114, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Instructions on a Current Life-Sustaining Treatment Options form” means the form developed under Health-General Article, §5-608.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Registrant” means an individual who registers the individual's advance directive with the Department.</text> </paragraph> <paragraph num="(9)"> <text>“Registry” means the depository for advance directives in the Department.</text> </paragraph> <paragraph num="(10)"> <text>“Secretary” means the Secretary of Health or a designee of the Secretary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Filing and Registration."> <paragraph num="A."> <text>An individual may submit an advance directive to the Department for registration.</text> </paragraph> <paragraph num="B."> <text>In order for the Department to register an advance directive, a registrant shall provide to the Department:</text> <paragraph num="(1)"> <text>A completed application on the form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>The required fee, as set forth in Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>An advance directive that contains:</text> <paragraph num="(a)"> <text>The registrant's signature;</text> </paragraph> <paragraph num="(b)"> <text>The date on which the advance directive was signed by the registrant; and</text> </paragraph> <paragraph num="(c)"> <text>The signatures of:</text> <paragraph num="(i)"> <text>Two witnesses as provided in Health-General Article, §5-602, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>If an Instructions on a Current Life-Sustaining Treatment Options form is submitted and the registrant is incapable of making an informed decision, the registrant's health care agent or surrogate and the registrant's attending physician.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>On receipt of the items set forth in §B of this regulation, the Department shall:</text> <paragraph num="(1)"> <text>Create a digital reproduction of the form and advance directive;</text> </paragraph> <paragraph num="(2)"> <text>Enter the reproduced form and advance directive into the advance directive database; and</text> </paragraph> <paragraph num="(3)"> <text>Assign each advance directive a file number and password.</text> </paragraph> </paragraph> <paragraph num="D."> <text>After processing the advance directive presented for registration, the Department shall provide to each registrant:</text> <paragraph num="(1)"> <text>A copy of the registrant's documents on file in the Registry;</text> </paragraph> <paragraph num="(2)"> <text>Instructions for accessing a copy of the registrant's advance directive;</text> </paragraph> <paragraph num="(3)"> <text>Instructions for amending or revoking an advance directive;</text> </paragraph> <paragraph num="(4)"> <text>A wallet card indicating registration of an advance directive; and</text> </paragraph> <paragraph num="(5)"> <text>A sticker to affix to a driver's license or identification card that shows that an advance directive has been filed with the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Nonregistration of Advance Directive."> <paragraph num="A."> <text>An individual is not required to register an advance directive with the Department.</text> </paragraph> <paragraph num="B."> <text>An advance directive that is not submitted to the Registry is valid in accordance with applicable law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Amendment or Revocation of a Registered Advance Directive."> <paragraph num="A."> <text>The registrant shall notify the Registry if a registered advance directive has been:</text> <paragraph num="(1)"> <text>Amended; or</text> </paragraph> <paragraph num="(2)"> <text>Revoked.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall amend the file of a registrant on receipt of:</text> <paragraph num="(1)"> <text>An application for amendment on a form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the amended advance directive that:</text> <paragraph num="(a)"> <text>Is complete; and</text> </paragraph> <paragraph num="(b)"> <text>Contains all information set forth in Regulation .03B of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A health care provider that becomes aware that a registrant has amended or revoked a registered advance directive shall, at the request of the registrant, provide the registrant with information on how to notify the Registry of the amendment or revocation.</text> </paragraph> <paragraph num="D."> <text>The Department shall delete the file of a registrant on receipt of:</text> <paragraph num="(1)"> <text>An application for revocation on a form provided by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Written documentation of revocation as provided in Health-General Article, §5-604, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fees — Repealed." /> <regulation prefix="Regulation" num=".07" heading="Disclosure of Information."> <paragraph num="A."> <text>The Department shall provide access to a registered advance directive to:</text> <paragraph num="(1)"> <text>The registrant; or</text> </paragraph> <paragraph num="(2)"> <text>An authorized person.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To access an advance directive:</text> <paragraph num="(1)"> <text>A registrant or a registrant's designee shall supply the registrant's file number and password; and</text> </paragraph> <paragraph num="(2)"> <text>A representative of a health care facility shall supply the facility's username and password.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Storage of Data."> <paragraph num="A."> <text>The Department shall establish a Registry that is:</text> <paragraph num="(1)"> <text>Secure, in accordance with data security standards customarily applied to the protection of electronic medical records; and</text> </paragraph> <paragraph num="(2)"> <text>Available 24 hours a day, 7 days a week.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may provide for services related to the establishment and operation of the Registry through contract with a person or agency.</text> </paragraph> <paragraph num="C."> <text>The Department or its contractor may store in the Registry only documents that are:</text> <paragraph num="(1)"> <text>Identical to those submitted by the registrant; and</text> </paragraph> <paragraph num="(2)"> <text>In a digital, read-only format preventing modification.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall destroy the paper copy of an advance directive submitted by a registrant when the paper copy has been fully and accurately converted to digital copy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Public Outreach."> <text>The Department shall carry out educational and outreach efforts to increase public awareness of the Registry.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Liability of Health Care Providers."> <text>A health care provider is not subject to criminal prosecution or civil liability and may not be determined to have engaged in unprofessional conduct by the appropriate licensing authority for:</text> <paragraph num="A."> <text>Failure to access the Registry; or</text> </paragraph> <paragraph num="B."> <text>Relying on information provided by the Registry.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Registry Funding."> <text>Implementation of this chapter is contingent on the availability of funds, in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§5-620 — 5-626, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 6, 2007 (34:24 Md. R. 2158)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> </subtitle> <subtitle num="24" heading="Maryland Health Care Commission"> <chapter num="01" heading="Procedural Regulations for Health Care Facilities and Services"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquisition” means:</text> <paragraph num="(a)"> <text>Any transfer of stock or assets that results in a change of the person or persons who control a health care facility; or</text> </paragraph> <paragraph num="(b)"> <text>The transfer of any stock or ownership interest in excess of 25 percent.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Adversely affected”, for purposes of determining interested party status in a Certificate of Need review, as defined in §B(35) of this regulation, means that a person:</text> <paragraph num="(a)"> <text>Is authorized to provide the same service as the applicant, in the same planning region, or contiguous planning region if the proposed new facility or service could reasonably provide services to residents in the contiguous area, and can demonstrate that the approval of the application:</text> <paragraph num="(i)"> <text>Would materially affect the quality of care at a health care facility that the person operates, such as by causing a reduction in the volume of services when volume is linked to maintaining quality of care; or</text> </paragraph> <paragraph num="(ii)"> <text>Would result in a substantial depletion of essential personnel or other resources at a health care facility that the person operates; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Can demonstrate to the reviewer that a health care facility operated by the person could suffer a potentially detrimental impact from the approval of a project before the Commission, in an issue area over which the Commission has jurisdiction, such that the reviewer, in the reviewer's sole discretion, determines that the person should be qualified as an interested party in the review.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Aggrieved party” means:</text> <paragraph num="(a)"> <text>An applicant or interested party who has submitted written exceptions to a proposed decision to the Commission and would be adversely affected by the final decision of the Commission; or</text> </paragraph> <paragraph num="(b)"> <text>The Secretary.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ambulatory Surgery Center.</text> <paragraph num="(a)"> <text>“Ambulatory surgery center” or “ASC” means any center, service, office, facility, or office of one or more health care practitioners, a group practice, or a non-rate-regulated center owned by a hospital that:</text> <paragraph num="(i)"> <text>Has no more than two operating rooms;</text> </paragraph> <paragraph num="(ii)"> <text>Operates primarily for the purpose of providing surgical services to patients who do not require overnight hospitalization; and</text> </paragraph> <paragraph num="(iii)"> <text>Seeks reimbursement from payors for the provision of ambulatory surgical services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Ambulatory surgery center” or “ASC” includes the following subcategories:</text> <paragraph num="(i)"> <text>An ASC-P, which has only procedure rooms;</text> </paragraph> <paragraph num="(ii)"> <text>An ASC-1, which has one operating room; and</text> </paragraph> <paragraph num="(iii)"> <text>An ASC-2, which has two operating rooms.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Ambulatory surgical facility” means any center, service, office, facility, or office of one or more health care practitioners or a group practice that:</text> <paragraph num="(a)"> <text>Has three or more operating rooms;</text> </paragraph> <paragraph num="(b)"> <text>Operates primarily for the purpose of providing surgical services to patients who do not require overnight hospitalization; and</text> </paragraph> <paragraph num="(c)"> <text>Seeks reimbursement from a third-party payor as an ambulatory surgical facility.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Approved bed” means a bed approved by the Commission in a Certificate of Need, but not yet licensed.</text> </paragraph> <paragraph num="(7)"> <text>“Bed capacity” or “physical bed capacity” means the total number of beds that a health care facility can set up and staff in space designed for and licensable for use by patients requiring an overnight stay at the facility.</text> </paragraph> <paragraph num="(8)"> <text>“By or on behalf of” includes a capital expenditure that affects the physical plant, service volume, or service capacity of a health care facility or health maintenance organization regardless of the source of the funds.</text> </paragraph> <paragraph num="(9)"> <text>“Capital expenditure” means:</text> <paragraph num="(a)"> <text>An expenditure, including predevelopment costs, which:</text> <paragraph num="(i)"> <text>Is made as part of an acquisition, improvement, expansion, or physical plant replacement;</text> </paragraph> <paragraph num="(ii)"> <text>Results in a change or relocation that would require a CON under Regulation .02A(2)—(4) of this chapter; and</text> </paragraph> <paragraph num="(iii)"> <text>Is made by or on behalf of a health care facility that under generally accepted accounting principles is not properly chargeable as an expense of operation and maintenance or is made to obtain any physical plant for a facility by lease or comparable arrangement;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A donation of a physical plant to a health care facility, if a Certificate of Need would be required for an expenditure by the health care facility to acquire the physical plant directly; or</text> </paragraph> <paragraph num="(c)"> <text>A transfer of a physical plant to a facility for less than fair market value, if the transfer of the physical plant at fair market value would be a capital expenditure.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Center for Health Care Facilities Planning and Development” means that center in the Commission that acts as the entry and information point for applications for Certificate of Need, requests for an exemption from Certificate of Need review, or other health care facility-related matters requiring action by the Commission, or its staff, as provided in this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Certificate of Conformance” means an approval issued by the Commission under Health-General Article, §19-120.1, Annotated Code of Maryland, that allows an acute general hospital to establish emergency percutaneous coronary intervention (PCI) services or elective PCI services without a Certificate of Need.</text> </paragraph> <paragraph num="(12)"> <text>“Certificate of Need” or “CON” means a certification of public need issued by the Commission under Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Certificate of Ongoing Performance” means an approval issued by the Commission that the cardiac surgery services, emergency PCI services, or elective PCI services provided by an acute general hospital meet standards evidencing continued quality under Health-General Article, §19-120.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(15)"> <text>“Comparable” when used to determine whether two or more CON applications are subject to comparative review means that the proposed projects are in the same health planning region and involve the addition or expansion of at least one of the same medical services.</text> </paragraph> <paragraph num="(16)"> <text>“Comparative review” means a review in which two or more comparable CON applications are reviewed together and ranked based on each application’s satisfaction of the CON review criteria because the most recently published need projections do not support the implementation of all comparable projects.</text> </paragraph> <paragraph num="(17)"> <text>“Comprehensive care facility” means a nursing home as defined under Health-General Article, §19-1401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“CON-approved service” means any health care service for which a CON was obtained, including:</text> <paragraph num="(a)"> <text>Medical services;</text> </paragraph> <paragraph num="(b)"> <text>Cardiac surgery services;</text> </paragraph> <paragraph num="(c)"> <text>Organ transplant services;</text> </paragraph> <paragraph num="(d)"> <text>Burn treatment services; and</text> </paragraph> <paragraph num="(e)"> <text>Neonatal intensive care services.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Consolidation” means the reconfiguration of two or more health care facilities within a merged asset system such that:</text> <paragraph num="(a)"> <text>The health care facilities in the merged asset system are combined and the total number of health care facilities of the merged asset system is reduced; or</text> </paragraph> <paragraph num="(b)"> <text>The medical services or bed capacity are reallocated among two or more health care facilities of the merged asset system.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Contested review” means a review in which a person has been recognized as an interested party.</text> </paragraph> <paragraph num="(21)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(22)"> <text>“Determination of coverage” means the written determination in accordance with Regulation .14A of this chapter whether CON or other Commission review is required for a project.</text> </paragraph> <paragraph num="(23)"> <text>“Executive Director” means the person appointed chief administrative officer of the Commission in accordance with Health-General Article, §19-106, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Existing health care facility” means a health care facility that is licensed by the Department.</text> </paragraph> <paragraph num="(25)"> <text>“Freestanding medical facility” has the meaning stated in Health-General Article, §19-3A-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(26)"> <text>“General hospice care program” has the meaning stated in Health-General Article, §l9-901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>Health Care Facility.</text> <paragraph num="(a)"> <text>“Health care facility” means:</text> <paragraph num="(i)"> <text>A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A limited service hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>An ambulatory surgical facility;</text> </paragraph> <paragraph num="(v)"> <text>An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision;</text> </paragraph> <paragraph num="(vi)"> <text>A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vii)"> <text>A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(viii)"> <text>A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ix)"> <text>A comprehensive care facility, except as provided by Regulation .03 of this chapter and Health-General Article, §19-114(d)(2), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(x)"> <text>Other health institutions, services, or programs that may be specified as requiring a CON under State law.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care facility” does not mean:</text> <paragraph num="(i)"> <text>A hospital or related institution operated, or listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts;</text> </paragraph> <paragraph num="(ii)"> <text>A kidney disease treatment facility, or the kidney disease treatment stations and services provided by or on behalf of a hospital, if the facility or the services do not include kidney transplant services or programs; or</text> </paragraph> <paragraph num="(iii)"> <text>The office of one or more individuals licensed to practice dentistry under Health Occupations Article, Title 4, Annotated Code of Maryland, for the purposes of practicing dentistry.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Health care project” means a health care project requiring a Certificate of Need as set forth in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(29)"> <text>“Health care services” means clinically-related patient services, including medical services.</text> </paragraph> <paragraph num="(30)"> <text>“Health maintenance organization” or “HMO” means a health maintenance organization under Health-General Article, §19-701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“Health planning region” means the area used for regulation of a particular service as provided in the State Health Plan.</text> </paragraph> <paragraph num="(32)"> <text>“Holder” means the applicant or applicants to whom the Commission awarded a Certificate of Need, an exemption from Certificate of Need, or other Commission approval for a project that has not received first use approval or, if necessary, a license from the Department for that project.</text> </paragraph> <paragraph num="(33)"> <text>Home Health Agency.</text> <paragraph num="(a)"> <text>“Home health agency” has the meaning stated in Health-General Article, §19-401(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Home health agency” includes a parent home health agency, as defined by the Centers for Medicare and Medicaid Services under 42 CFR §484.2.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Hospital capital threshold” has the meaning stated in Health-General Article, §19-120(a)(4), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(35)"> <text>“Initiation of construction” means:</text> <paragraph num="(a)"> <text>For a new health care facility or expansion of an existing health care facility, that an approved project has:</text> <paragraph num="(i)"> <text>Obtained all permits and approvals considered necessary by applicable federal, State, and local authorities to initiate construction;</text> </paragraph> <paragraph num="(ii)"> <text>Completed all necessary preconstruction site work; and</text> </paragraph> <paragraph num="(iii)"> <text>Started the installation of the foundation system with placement of permanent components such as reinforcing steel, concrete, and piles; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For the renovation of an existing health care facility, that an approved project has:</text> <paragraph num="(i)"> <text>Obtained all permits and approvals considered necessary by applicable federal, State, and local authorities to initiate renovation; and</text> </paragraph> <paragraph num="(ii)"> <text>Started the demolition or relocation of affected services necessary to undertake the renovation project.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Interested party” means a person recognized by a reviewer as an interested party, including:</text> <paragraph num="(a)"> <text>Any applicant who has submitted a competing application in a comparative review;</text> </paragraph> <paragraph num="(b)"> <text>The staff of the Commission;</text> </paragraph> <paragraph num="(c)"> <text>A local health department in the jurisdiction or, in the case of regional services, in the planning region, in which the proposed facility or service is to be offered;</text> </paragraph> <paragraph num="(d)"> <text>In the review of a replacement acute general hospital project proposed by or on behalf of a regional health system that serves multiple contiguous jurisdictions, a jurisdiction within the region served by the regional health system that does not contain the proposed replacement acute general hospital project; and</text> </paragraph> <paragraph num="(e)"> <text>A person who has demonstrated to the reviewer that it meets the definition of adversely affected by the approval of a proposed project.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Intermediate care” means:</text> <paragraph num="(a)"> <text>A planned regimen of 24-hour professional directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting for individuals with substance abuse disorder, including American Society of Addiction Medicine (ASAM) Level 3.7 medically monitored intensive inpatient services; and</text> </paragraph> <paragraph num="(b)"> <text>Residential care, treatment, or custody of individuals with intellectual disability or persons with related conditions.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Jurisdiction” means the 23 counties of Maryland and Baltimore City.</text> </paragraph> <paragraph num="(39)"> <text>Licensed Bed Capacity.</text> <paragraph num="(a)"> <text>“Licensed bed capacity” means the number of health care facility beds in any of the medical service categories or subcategories, as they appear in the Commission's inventories of licensed service capacity.</text> </paragraph> <paragraph num="(b)"> <text>“Licensed bed capacity” for acute general hospitals:</text> <paragraph num="(i)"> <text>Means the capacity authorized by the Secretary under Health-General Article, §19-307.2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Does not mean the number of holding beds to support hospital emergency services, bassinets, beds dedicated to observation of patients, an outpatient service, or recovery beds to support ambulatory surgical services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(40)"> <text>“Limited service hospital” means a health care facility that:</text> <paragraph num="(a)"> <text>Is licensed as a hospital;</text> </paragraph> <paragraph num="(b)"> <text>Changes the type or scope of health care services offered by eliminating the facility's capability to admit or retain patients for overnight hospitalization;</text> </paragraph> <paragraph num="(c)"> <text>Retains an emergency or urgent care center; and</text> </paragraph> <paragraph num="(d)"> <text>Complies with the regulations adopted by the Secretary under Health-General Article, §19-307.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(41)"> <text>“Local health department” means the health department in a jurisdiction or a body designated by that jurisdiction to perform health planning functions.</text> </paragraph> <paragraph num="(42)"> <text>“Long-term significant relationship” means a relationship characterized by mutual economic dependence, demonstrated by evidence such as a joint lease or mortgage or power of attorney, and evidence of common legal residence shown by driver's licenses, voter registration, or other identification.</text> </paragraph> <paragraph num="(43)"> <text>“Maryland Health Care Commission” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(44)"> <text>“Medical service” means:</text> <paragraph num="(a)"> <text>Any of the following categories of health care services as they appear in the Commission's inventories of service capacity:</text> <paragraph num="(i)"> <text>Medical/surgical/gynecological/addictions;</text> </paragraph> <paragraph num="(ii)"> <text>Obstetrics;</text> </paragraph> <paragraph num="(iii)"> <text>Pediatrics;</text> </paragraph> <paragraph num="(iv)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(v)"> <text>Rehabilitation;</text> </paragraph> <paragraph num="(vi)"> <text>Chronic care;</text> </paragraph> <paragraph num="(vii)"> <text>Comprehensive care;</text> </paragraph> <paragraph num="(viii)"> <text>Extended care;</text> </paragraph> <paragraph num="(ix)"> <text>Intermediate care; or</text> </paragraph> <paragraph num="(x)"> <text>Residential treatment center care; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A subcategory of the rehabilitation, psychiatry, comprehensive care, or intermediate care categories of medical services for which the State Health Plan provides a need projection methodology or specific standards.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Merged asset system” means an organization comprised of two or more regulated health care facilities under common ownership or control.</text> </paragraph> <paragraph num="(46)"> <text>“Merger” means the union of two or more health care facilities by the transfer of all the property of one or more of them to one of them, which continues in existence, the others being merged therein.</text> </paragraph> <paragraph num="(47)"> <text>“Multiphased plan of construction” means a plan of construction for an addition, replacement, modernization, relocation, or conversion of an existing health care facility that involves distinct elements of construction, demolition, or renovation that require sequential implementation such that one element can be initiated before subsequent elements of the overall project can be initiated.</text> </paragraph> <paragraph num="(48)"> <text>“Nursing home” has the meaning under Health-General Article, §19-1401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(49)"> <text>“Operating room” means a sterile room in a surgical suite that meets the requirements of a restricted area and is designated and equipped for performing surgical operations or other invasive procedures that require an aseptic field.</text> </paragraph> <paragraph num="(50)"> <text>“Other Commission approval” means approval of a Certificate of Conformance, Certificate of Ongoing Performance, or an exemption from CON review.</text> </paragraph> <paragraph num="(51)"> <text>“Partial closing” or “partial closure” means the closure or decommission of one or more but not all CON-approved services offered by a health care facility.</text> </paragraph> <paragraph num="(52)"> <text>“Participating entity” means a person recognized by the Executive Director as a participating entity and may include:</text> <paragraph num="(a)"> <text>A third-party payor including:</text> <paragraph num="(i)"> <text>An insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A health maintenance organization that holds a certificate of authority in Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A union that is providing a health plan to union members on behalf of an employer in a jurisdiction in which the proposed project will be located or from which an existing health care facility seeks to relocate;</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy benefit manager; and</text> </paragraph> <paragraph num="(v)"> <text>A self-insured employer offering health benefits through the Employer Retirement Insurance Security Act of 1974;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A municipality where the proposed project will be located or from which an existing health care facility seeks to relocate; or</text> </paragraph> <paragraph num="(c)"> <text>In the case of a hospital project, a local health department in a jurisdiction that borders a jurisdiction in which a proposed facility or service will be located.</text> </paragraph> </paragraph> <paragraph num="(53)"> <text>“Person” includes an individual, receiver, trustee, guardian, executor, administrator, fiduciary, or representative of any kind and any partnership, firm, association, limited liability company, limited liability partnership, public or private corporation, or other entity.</text> </paragraph> <paragraph num="(54)"> <text>Personal Physician.</text> <paragraph num="(a)"> <text>“Personal physician” means a physician licensed to practice medicine who:</text> <paragraph num="(i)"> <text>Was chosen by an individual;</text> </paragraph> <paragraph num="(ii)"> <text>Has an established physician-patient relationship with the individual; and</text> </paragraph> <paragraph num="(iii)"> <text>Has provided health care services to the individual.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Personal physician” does not mean an owner of, an employee of, a person under contract with, or a person who has a material financial interest in a continuing care retirement community, its management company, or related entity.</text> </paragraph> </paragraph> <paragraph num="(55)"> <text>Predevelopment Costs.</text> <paragraph num="(a)"> <text>“Predevelopment costs” means all costs related to the preliminary development of a project, which include, but are not limited to, the costs of preliminary plans, studies, surveys, architectural designs, plans, reports, application fees, legal fees, financing fees, consulting fees, working drawings, or specifications undertaken in preparation for the development or offering of a health care project.</text> </paragraph> <paragraph num="(b)"> <text>“Predevelopment costs” does not include activities routinely undertaken by a health care facility as a part of its internal management or long-range planning process.</text> </paragraph> </paragraph> <paragraph num="(56)"> <text>“Primary service area” means:</text> <paragraph num="(a)"> <text>The Maryland postal ZIP code areas from which the first 60 percent of a hospital's patient discharges originate during the most recent 12-month period, where:</text> <paragraph num="(i)"> <text>The discharges from each ZIP code area are ordered from largest to smallest number of discharges; and</text> </paragraph> <paragraph num="(ii)"> <text>Two or more ZIP code areas having the same numbers of discharges are ordered from the largest to smallest based on the percentage of the hospital’s discharges originating from the ZIP code area in the most recent 12-month period;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Point ZIP codes physically within any of the ZIP code areas designated in §B(54) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Maryland ZIP code areas physically contiguous to any of the ZIP codes designated in §B(54) of this regulation that provided 50 percent or more of their discharges to the hospital in the most recent 12-month period; and</text> </paragraph> <paragraph num="(d)"> <text>For a merged asset system, the ZIP code areas that are tabulated separately for each hospital, and all ZIP code areas identified for each hospital which are included in the primary service area of the merged asset system.</text> </paragraph> </paragraph> <paragraph num="(57)"> <text>Public Obligation.</text> <paragraph num="(a)"> <text>“Public obligation” means a bond, note, evidence of indebtedness, or other obligation to repay borrowed money issued by:</text> <paragraph num="(i)"> <text>The Maryland Health and Higher Educational Facilities Authority;</text> </paragraph> <paragraph num="(ii)"> <text>The State, or any agency, instrumentality, or public corporation of the State;</text> </paragraph> <paragraph num="(iii)"> <text>A governmental entity described in Local Government Article, §19-205(a), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>The Mayor and City Council of Baltimore; or</text> </paragraph> <paragraph num="(v)"> <text>A municipal corporation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Public obligation” does not include an obligation, or portion of an obligation, if:</text> <paragraph num="(i)"> <text>The principal of and interest on the obligation or the portion of the obligation is insured by an effective municipal bond insurance policy and issued on behalf of a hospital that voluntarily closed in accordance with Health-General Article, §19-120(l); and</text> </paragraph> <paragraph num="(ii)"> <text>The proceeds of the obligation or the portion of the obligation are used to finance wholly or partly a facility or part of a facility that is used primarily to provide outpatient services at a location other than the hospital or that is used primarily by physicians who are not employees of the hospital to provide services to nonhospital patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(58)"> <text>“Regional health system” means a hospital whose primary or secondary service area cover multiple jurisdictions.</text> </paragraph> <paragraph num="(59)"> <text>“Rehabilitation facility” means an inpatient facility that:</text> <paragraph num="(a)"> <text>Is organized for the primary purpose of assisting in the rehabilitation of persons with disabilities through an integrated program of medical and other services, which are provided under competent professional supervision;</text> </paragraph> <paragraph num="(b)"> <text>Is licensed as a special rehabilitation hospital; and</text> </paragraph> <paragraph num="(c)"> <text>Complies with the regulations adopted by the Secretary under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(60)"> <text>“Religious order” means an incorporated, not-for-profit organization:</text> <paragraph num="(a)"> <text>That is owned or is wholly operated by an entity founded and operating for the sole purpose of carrying out religious precepts; and</text> </paragraph> <paragraph num="(b)"> <text>Whose members have taken the vows required by the order and have devoted their lives to religious service, to the exclusion of lay life and activities.</text> </paragraph> </paragraph> <paragraph num="(61)"> <text>“Residential treatment center” has the meaning stated in Health-General Article, §19-301(p), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(62)"> <text>“Reviewer” means one Commissioner, appointed by the Executive Director of the Commission, who:</text> <paragraph num="(a)"> <text>Evaluates a Certificate of Need application;</text> </paragraph> <paragraph num="(b)"> <text>Prepares a proposed decision for the consideration of the full Commission; and</text> </paragraph> <paragraph num="(c)"> <text>Serves as presiding officer at an evidentiary hearing on an application or applications, if any.</text> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(64)"> <text>“Service area” means the geographic area from which a health care facility or provider draws its patients. Unless otherwise specified in a relevant State Health Plan chapter, service area means the zip code areas from which the greatest number of patients reside, which, when ordered from largest to smallest, comprise the top 85 percent of patients who receive a specific service at a health care facility for the most recent 12-month period of data available.</text> </paragraph> <paragraph num="(65)"> <text>“State Health Plan” means the State Health Plan for Facilities and Services and its modifications or additions, adopted by the Commission pursuant to Health-General Article, §19-118, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Coverage."> <paragraph num="A."> <text>Except as provided in Regulations .03—.05 of this chapter or as otherwise provided by law, a CON is required before:</text> <paragraph num="(1)"> <text>A new health care facility is built, developed, or established;</text> </paragraph> <paragraph num="(2)"> <text>An existing health care facility is moved to another site, unless the relocation is:</text> <paragraph num="(a)"> <text>The result of a partial or complete replacement of an existing hospital or related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland, and is to another part of the site or immediately adjacent to the site of the existing hospital or related institution;</text> </paragraph> <paragraph num="(b)"> <text>Of an existing health care facility owned or controlled by a merged asset system, subject to the provisions of Regulations .03E or .04A(2) of this chapter, whichever is applicable; or</text> </paragraph> <paragraph num="(c)"> <text>By a hospital converting to a limited service hospital, subject to the provisions of Regulation .04A(4) of this chapter, and is to a site within the immediate area, as determined by the Commission, as described in §B of this regulation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The bed capacity of a health care facility is changed;</text> </paragraph> <paragraph num="(4)"> <text>The type or scope of any health care service offered by a health care facility is changed, and the change:</text> <paragraph num="(a)"> <text>Establishes a new medical service;</text> </paragraph> <paragraph num="(b)"> <text>Establishes a new cardiac surgery, organ transplant surgery, burn treatment, or neonatal intensive care program;</text> </paragraph> <paragraph num="(c)"> <text>Establishes a new home health agency, general hospice care program, or ambulatory surgical facility;</text> </paragraph> <paragraph num="(d)"> <text>Builds or expands surgical capacity in a hospital, freestanding medical facility subject to rate regulation by the Health Services Cost Review Commission, or ambulatory surgical facility;</text> </paragraph> <paragraph num="(e)"> <text>Results in:</text> <paragraph num="(i)"> <text>The establishment of a new parent home health agency; or</text> </paragraph> <paragraph num="(ii)"> <text>The expansion of an existing home health agency into a jurisdiction in which it was not previously authorized by the Commission to operate;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Eliminates an existing medical service; or</text> </paragraph> <paragraph num="(g)"> <text>Closes an existing health care facility or converts it to a non-health-related use; or</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A hospital makes a capital expenditure, as defined in Health-General Article, §19-120(k), Annotated Code of Maryland, and in this chapter, that exceeds the hospital capital threshold, including a capital expenditure:</text> <paragraph num="(a)"> <text>For the relocation of an existing health care facility owned or controlled by a merged asset system, except as provided in Regulation .03E of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>By a relocated health care facility to permit the facility to offer a new health care service for which CON is otherwise required.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Definition of Immediate Area for Limited Service Hospital Conversion.</text> <paragraph num="(1)"> <text>For the purpose of §A(2)(c) of this regulation, “immediate area” means a location on the site of the existing hospital, or on an adjacent site.</text> </paragraph> <paragraph num="(2)"> <text>A hospital may provide evidence as to why the Commission should approve a site for a limited service hospital beyond the immediate area of the converting hospital.</text> </paragraph> <paragraph num="(3)"> <text>The Commission may not approve a site for a limited service hospital unless the site is within:</text> <paragraph num="(a)"> <text>A 5-mile radius of the site of the hospital proposing the conversion; and</text> </paragraph> <paragraph num="(b)"> <text>Its primary service area.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A person may not divide a project into component parts except as permitted by this chapter. Commission staff shall issue a determination regarding whether two or more apparently individual projects actually represent component parts of a single project, considering, among other things, the timing of the projects, the functional areas of a facility to be affected, the number of construction contracts entered into, and whether expenditures under one contract depend upon the completion of a prior contract.</text> </paragraph> <paragraph num="D."> <text>Proposed Change After Acquisition. If a person acquires an existing health care facility or service without a CON, in accordance with Regulation .03 of this chapter, and proposes to change the health care services it provides or its bed capacity, the proposed change requires review and approval in accordance with §A of this regulation.</text> </paragraph> <paragraph num="E."> <text>A health maintenance organization, or health care facility that either controls, directly or indirectly, or is controlled by an HMO or a group of HMOs, shall obtain a CON before it builds, develops, operates, or participates in building, developing, or operating:</text> <paragraph num="(1)"> <text>A hospital; or</text> </paragraph> <paragraph num="(2)"> <text>Any other health care project for which a CON is required under §A of this regulation, unless at least 90 percent of the patients who will receive health care services from the project will be individuals enrolled in that health maintenance organization.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If a person is uncertain whether a project requires a Certificate of Need, the person shall request a determination of coverage in accordance with Regulation .14A of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Non-Coverage by Certificate of Need or Other Commission Approval."> <paragraph num="A."> <text>Acquisition of an Existing Health Care Facility.</text> <paragraph num="(1)"> <text>At least 30 days before closing on a contract to acquire a health care facility, the person acquiring the facility shall notify the Commission in writing, with a copy to the local health officer in each affected jurisdiction and the appropriate State licensing agency, of the intent to acquire the facility, and include the following information:</text> <paragraph num="(a)"> <text>The health care services provided by the facility;</text> </paragraph> <paragraph num="(b)"> <text>The bed capacity, or jurisdiction served, if a community-based service;</text> </paragraph> <paragraph num="(c)"> <text>Complete organizational charts that describe the ownership of the health care facility prior to and after the proposed acquisition;</text> </paragraph> <paragraph num="(d)"> <text>A description of any unsatisfied conditions imposed by the Commission on the facility and an affirmation that the person acquiring the facility will abide by any conditions still in effect; and</text> </paragraph> <paragraph num="(e)"> <text>Any other information required by this chapter, by the State Health Plan chapter applicable to the health care facility, or requested by Commission staff.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Deemed Approval.</text> <paragraph num="(a)"> <text>Except for acquisitions of a nursing home, CON review is not required if Commission staff does not issue either a determination of coverage or notice that timely or complete notice was not received within 60 days of receipt of a notice from the person acquiring the health care facility.</text> </paragraph> <paragraph num="(b)"> <text>Upon request, Commission staff shall provide written confirmation that an acquisition was deemed approved under this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Commission staff’s determination that CON or other Commission review is not required remains valid for 180 days from its issuance. A new determination of coverage shall be required if the acquisition is not completed within that time period.</text> </paragraph> <paragraph num="(4)"> <text>If the acquisition is completed, the buyer shall sign a notice of completion of acquisition and file it with the Commission within 15 days of the completion of the acquisition.</text> </paragraph> <paragraph num="(5)"> <text>Conditions imposed by the Commission on a health care facility survive an acquisition of the facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Acquisition of a Nursing Home, Home Health Agency, or Hospice.</text> <paragraph num="(1)"> <text>In addition to providing the information required in §A of this regulation, a person seeking to acquire a nursing home shall obtain approval for the acquisition in accordance with Regulation .21 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>In addition to providing the information required in §A of this regulation, a person seeking to acquire a home health agency or hospice shall:</text> <paragraph num="(a)"> <text>Identify each person with an ownership interest in the acquiring entity or a related or affiliated entity, including</text> <paragraph num="(i)"> <text>The percentage of ownership interest of each such person; and</text> </paragraph> <paragraph num="(ii)"> <text>The history of each such person’s experience in ownership or operation of health care facilities;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide information on corporate structure and affiliations of the acquirer, purchase price, source of funds, and other relevant data as requested;</text> </paragraph> <paragraph num="(c)"> <text>Affirm that the services provided will not change as a result of the proposed acquisition and that its commitment to Medicaid participation, if any, will not decrease as a result of the proposed acquisition; and</text> </paragraph> <paragraph num="(d)"> <text>Affirm under penalties of perjury, that within the last 10 years no owner or former owner of the purchaser, or member of senior management or management organization, or a current or former owner or senior manager of any related or affiliated entity has been convicted of a felony or crime, or pleaded guilty, nolo contendere, entered a best interest plea of guilty, received a diversionary disposition regarding a felony or crime, and that the purchaser or a related or affiliated entity has not paid a civil penalty in excess of $10 million dollars that relates to the ownership or management of a health care facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Disqualification for Acquisition. A nursing home, home health agency, or hospice may not be acquired by an entity if an owner or member of senior management or an owner or member of senior management of a related or affiliated entity of the acquiring entity has been convicted of a felony or crime or pleaded guilty, nolo contendere, entered a best interest plea of guilty, or received a diversionary disposition regarding a felony or crime within the last 10 years, unless:</text> <paragraph num="(a)"> <text>All of the individuals involved in the fraud or abuse are no longer associated with the entity or any of its related or affiliated entities;</text> </paragraph> <paragraph num="(b)"> <text>Each entity has fully complied with each applicable plan of correction; and</text> </paragraph> <paragraph num="(c)"> <text>If applicable, each entity has fully complied with each condition of the imposition of a civil penalty or agreed disposition.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In an acquisition of a home health agency or hospice, the purchaser may only acquire the authority to provide services in jurisdictions for which the facility being acquired was granted a CON or is otherwise recognized by the Commission as having legal authorization.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Closure of a Health Care Facility.</text> <paragraph num="(1)"> <text>A CON is not required to close a health care facility or part of a health care facility, including a State hospital, if it provides notice to the Commission at least 90 days prior to the closing or 45 days prior to the partial closing and complies with the provisions of §C(2)—(4) of this regulation, if applicable.</text> </paragraph> <paragraph num="(2)"> <text>An acute general hospital shall hold a public informational hearing in accordance with Regulation .04D of this chapter if the hospital:</text> <paragraph num="(a)"> <text>Files a notice of the proposed closing of the hospital with the Commission; or</text> </paragraph> <paragraph num="(b)"> <text>Is located in a jurisdiction with fewer than three acute general hospitals and files a notice of the partial closing of the hospital.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission may require a health care facility not covered by §C(2) of this regulation to hold a public information hearing in accordance with Regulation .04D of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>If a hospital that intends to close has outstanding public obligations issued on its behalf, written notice of its intended closing shall be given to the Maryland Health and Higher Educational Facilities Authority and the Health Services Cost Review Commission by the:</text> <paragraph num="(a)"> <text>Commission, within 5 days after receiving a written notification by the hospital of its intended closure;</text> </paragraph> <paragraph num="(b)"> <text>Hospital, within 10 days of filing with the Commission its written notification of its intended closure, along with a written statement of all public obligations issued on behalf of the hospital that provides the information required by Economic Development Article, §10-346(a)(2), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Commission, that the hospital held a public informational hearing in consultation with the Commission in the jurisdiction where the hospital is located.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Temporary Delicensure or Suspension of Bed Capacity, Health Care Facility, or CON-Approved Service.</text> <paragraph num="(1)"> <text>A temporary delicensure of licensed bed capacity or a licensed and operating health care facility or a temporary suspension of a CON-approved service does not require CON review, and the Commission will retain the bed capacity or health care facility on its inventory or permit the reimplementation of the CON-approved service without obtaining a CON for up to 1 year, if the owner or licensed operator:</text> <paragraph num="(a)"> <text>Provides written notice to the Commission at least 30 days before the proposed temporary delicensure or temporary service suspension;</text> </paragraph> <paragraph num="(b)"> <text>Identifies good cause for the proposed temporary delicensure or temporary service suspension;</text> </paragraph> <paragraph num="(c)"> <text>States the intention either to bring the bed capacity back onto the facility's license or relicense the health care facility or reimplement the CON-approved service at the end of the 1-year period, or to notify the Commission that it intends to take another of the actions permitted under this subsection; and</text> </paragraph> <paragraph num="(d)"> <text>Has received authorization from the Executive Director for the temporary delicensure or temporary service suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Temporary Delicensure of Nursing Home Bed Capacity after an Acquisition.</text> <paragraph num="(a)"> <text>A temporary delicensure of licensed bed capacity or a licensed and operating nursing home following an acquisition does not require CON review, and the Commission will retain the bed capacity or the nursing home on its inventory for up to 3 years immediately following the acquisition, if the person who acquired the nursing home:</text> <paragraph num="(i)"> <text>Provides written notice to the Commission at least 30 days before the proposed temporary delicensure;</text> </paragraph> <paragraph num="(ii)"> <text>Demonstrates the temporary delicensure is needed to reduce the number of resident rooms that contain more than 2 beds;</text> </paragraph> <paragraph num="(iii)"> <text>States the intention either to bring the bed capacity back onto the facility's license or relicense the health care facility at the end of the 3-year period, or to notify the Commission that it intends to take another of the actions permitted under §D of this regulation; and</text> </paragraph> <paragraph num="(iv)"> <text>Has received authorization from the Executive Director for the temporary delicensure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Executive Director may extend the period of a temporary delicensure under §D of this regulation beyond 3 years for good cause including:</text> <paragraph num="(i)"> <text>Demonstrated progress toward eliminating multi-bedded rooms by expanding the existing facility;</text> </paragraph> <paragraph num="(ii)"> <text>A pending or approved application for a CON or exemption from CON review to relocate the beds to another existing or new facility;</text> </paragraph> <paragraph num="(iii)"> <text>Evidence of physical or legal constraints; or</text> </paragraph> <paragraph num="(iv)"> <text>Evidence of good faith negotiations to sell the beds.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Bed capacity or a facility that has been authorized by the Commission to be temporarily delicensed or a CON-approved service that has been authorized by the Commission to be temporarily suspended is not subject to the provisions of this section:</text> <paragraph num="(a)"> <text>During the pendency at the Commission of a letter of intent to apply or an application for CON approval involving the temporarily delicensed bed capacity or facility or the temporarily suspended CON-approved service;</text> </paragraph> <paragraph num="(b)"> <text>If the Commission has issued a Certificate of Need to reimplement the facility's temporarily delicensed bed capacity or the facility’s temporarily suspended CON-approved service;</text> </paragraph> <paragraph num="(c)"> <text>If the Commission has approved a request pursuant to Regulation .03 or .04 of this chapter to reimplement the bed capacity, facility or CON-approved service, and has determined that the bed capacity, facility, or CON-approved service may be reimplemented without a CON or other Commission approval, including but not limited to actions that may be undertaken by a merged asset system of which the facility is a member;</text> </paragraph> <paragraph num="(d)"> <text>If the Commission receives a notice of acquisition of the temporarily delicensed bed capacity or facility and the buyer and seller timely complete the acquisition, in accordance with Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(e)"> <text>If the Commission receives written notification that the owner or operator of the temporarily delicensed bed capacity or facility has applied for relicensure or reimplementation of the temporarily suspended CON-approved service.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The requirements and procedures in this subsection do not apply to:</text> <paragraph num="(a)"> <text>A proposal to close, on either a temporary or a permanent basis:</text> <paragraph num="(i)"> <text>An acute general hospital or part of a hospital, including a medical service, in a jurisdiction with fewer than three acute general hospitals; or</text> </paragraph> <paragraph num="(ii)"> <text>A health care facility that provides any medical service approved by the Commission as a regional or Statewide health resource; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A temporary interruption of a CON-approved service that does not exceed 30 days.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>This section does not substitute any notice or approvals that may be required from another body that regulates the bed capacity, health care facility, or CON-approved service.</text> </paragraph> <paragraph num="(6)"> <text>A health care facility may not request authorization by the Commission to temporarily delicense bed capacity or the entire health care facility or to temporarily suspend a CON-approved service more than one time in a 1-year period.</text> </paragraph> <paragraph num="(7)"> <text>No fewer than 30 days before the end of the 1-year or other applicable period, a health care facility that has temporarily delicensed bed capacity or its entire facility or has temporarily suspended a CON-approved service shall notify the Commission that, before the end of the 1-year or other applicable period, it will:</text> <paragraph num="(a)"> <text>Apply to relicense the bed capacity or the entire facility temporarily delicensed or reimplement the CON-approved service temporarily suspended pursuant to this subsection;</text> </paragraph> <paragraph num="(b)"> <text>Submit and receive the Executive Director's approval of a specific plan for the relicensure of the bed capacity or facility or for the reimplementation of the temporarily suspended CON-approved service, that:</text> <paragraph num="(i)"> <text>Imposes stated time frames by which steps toward the relicensure of the bed capacity or facility or reimplementation of the service will be accomplished, or the bed capacity, facility, or service will be deemed abandoned; and</text> </paragraph> <paragraph num="(ii)"> <text>May be revised upon a proposal by the owner or operator, with the approval of the Executive Director;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>File a letter of intent, followed within 60 days by a Certificate of Need application, or request the applicable level of Commission action pursuant to Regulations .03 and .04 of this chapter, for the relocation of the bed capacity or facility, or for a capital expenditure deemed necessary to relicense the temporarily delicensed beds or facility or necessary to reimplement the temporarily suspended CON-approved service;</text> </paragraph> <paragraph num="(d)"> <text>Execute a binding contract to transfer ownership of the health care facility, if the requirements of §A of this regulation are met;</text> </paragraph> <paragraph num="(e)"> <text>Execute a binding contract to transfer ownership of the previously licensed bed capacity, contingent on the filing within 90 days for those filings not subject to a published review cycle or upon the Commission’s next published review schedule of a letter of intent to apply for CON approval, or other applicable level of Commission action pursuant to Regulations .03 and .04 of this chapter if required, to relocate the bed capacity; or</text> </paragraph> <paragraph num="(f)"> <text>Relinquish the bed capacity or the authorization to provide the CON-approved service, or seek the appropriate Commission approval to delicense and permanently close the health care facility.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The Executive Director may extend the period of a temporary delicensure or temporary service suspension under this subsection beyond 1 year for good cause.</text> </paragraph> <paragraph num="(9)"> <text>An application for a CON to reimplement at another location any previously operating bed capacity that has not operated for 2 or more years shall demonstrate that the bed capacity is needed in the jurisdiction.</text> </paragraph> <paragraph num="(10)"> <text>Abandonment of Bed Capacity, Health Care Facility, or Service.</text> <paragraph num="(a)"> <text>If, at the end of the 1-year period or other time period permitted under this section, the requirements of §C(5) or (7) of this regulation have not been met, no request for an extension of time has been granted pursuant to §C(6) of this regulation, and the previously delicensed bed capacity or facility has not been relicensed or the previously suspended service has not been reimplemented, the bed capacity, health care facility, or service is deemed abandoned by its owner or operator.</text> </paragraph> <paragraph num="(b)"> <text>The Commission shall issue a written notice to the owner of the affected facility, and to its licensed operator if the facility is not operated by its owner, of the opportunity to respond within 30 days before the abandonment is considered final, in order to demonstrate that the previously delicensed bed capacity or facility has been relicensed or the previously suspended service has been reimplemented.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A CON is not required to relocate an existing health care facility owned or controlled by a merged asset system, if:</text> <paragraph num="(1)"> <text>The proposed relocation is not across jurisdictional boundaries and is to a site in:</text> <paragraph num="(a)"> <text>The primary service area of the hospital to be relocated; or</text> </paragraph> <paragraph num="(b)"> <text>The service area of the non-hospital health care facility to be relocated;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 45 days before the proposed relocation, notice is filed with the Commission, which will publish notice of the proposed relocation in the Maryland Register and a newspaper of general circulation in the affected area; and</text> </paragraph> <paragraph num="(3)"> <text>The relocation of the existing health care facility does not:</text> <paragraph num="(a)"> <text>Change the type or scope of health care services offered; and</text> </paragraph> <paragraph num="(b)"> <text>In the case of a hospital, require a capital expenditure that exceeds the hospital capital threshold, except as provided in §J of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Change in Bed Capacity.</text> <paragraph num="(1)"> <text>A CON is not required to increase or decrease bed capacity if:</text> <paragraph num="(a)"> <text>For a health care facility that is not an acute general hospital, the change does not exceed ten beds or 10 percent of the facility’s total bed capacity, whichever is less, and the facility’s licensed bed capacity has not changed in the preceding 2 years;</text> </paragraph> <paragraph num="(b)"> <text>For a special rehabilitation hospital or a residential treatment center, the change does not exceed ten beds or 40 percent of its current bed capacity, whichever is less, and the facility’s licensed bed capacity has not changed in the preceding 2 years;</text> </paragraph> <paragraph num="(c)"> <text>For an acute general hospital located in a jurisdiction with three or more acute general hospitals, the change:</text> <paragraph num="(i)"> <text>Is between hospitals in a merged asset system located within the same health planning region;</text> </paragraph> <paragraph num="(ii)"> <text>Does not involve comprehensive care or extended care beds;</text> </paragraph> <paragraph num="(iii)"> <text>Does not occur earlier than 45 days after a notice of intent to reallocate bed capacity is filed with the Commission; and</text> </paragraph> <paragraph num="(iv)"> <text>Does not create a new health care service through the relocation of beds from one jurisdiction to another jurisdiction pursuant to this subsection;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The change in bed capacity is the result of the annual recalculation of licensed bed capacity in acute general hospitals provided for under Health-General Article, §19-307.2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>For an existing medical service provided by an acute general hospital:</text> <paragraph num="(i)"> <text>The total bed capacity of the hospital does not increase;</text> </paragraph> <paragraph num="(ii)"> <text>The change is maintained for at least a 1-year period, unless modified pursuant to CON or exemption from CON, or as a result of the annual recalculation of hospital licensed bed capacity required at Health-General Article, §19-307.2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>The hospital notifies the Commission at least 45 days before the proposed change in bed capacity of its medical services; or</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>At least 45 days before increasing or decreasing bed capacity, written notice of the intent to change bed capacity is filed with the Commission, and the increase or decrease in bed capacity will occur in:</text> <paragraph num="(i)"> <text>An existing general hospice that has a current license issued by the Secretary and involves an increase in bed capacity for the provision of inpatient hospice care under the facility’s current license; or</text> </paragraph> <paragraph num="(ii)"> <text>An existing intermediate care facility that offers residential or intensive substance-related disorder treatment services for withdrawal management and treatment under the facility’s current license issued by the Secretary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as otherwise provided in this regulation, a CON is not required to decrease bed capacity at a health care facility if at least 45 days before decreasing bed capacity, written notice of the intent to change bed capacity is filed with the Commission.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A CON is not required for a non-hospital health care facility project by a health maintenance organization if:</text> <paragraph num="(1)"> <text>At least 90 percent of the patients who will receive health care services from the facility are enrolled in the health maintenance organization;</text> </paragraph> <paragraph num="(2)"> <text>The health maintenance organization requests a determination of coverage from Commission staff that describes its proposed project, including its street address, and the health care service to be provided; and</text> </paragraph> <paragraph num="(3)"> <text>Commission staff issues a determination that CON or other Commission review is not required.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A home health agency is not required to obtain a CON to open a branch office, as defined by the Centers for Medicare and Medicaid Services at 42 CFR §484.2, although notice to the Commission is required.</text> </paragraph> <paragraph num="I."> <text>Religious Orders.</text> <paragraph num="(1)"> <text>A CON is not required before a religious order seeks licensure to operate a comprehensive care facility for the exclusive use of members of that religious order, provided that the religious order seeks and receives a determination of coverage from Commission staff that a CON is not required.</text> </paragraph> <paragraph num="(2)"> <text>The request for a determination of coverage shall provide the following:</text> <paragraph num="(a)"> <text>The name and address of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The number of beds in the facility;</text> </paragraph> <paragraph num="(c)"> <text>The name of the religious order that will own and operate the facility;</text> </paragraph> <paragraph num="(d)"> <text>An affirmation that the facility will be owned and operated by the religious order for the exclusive use of its members; and</text> </paragraph> <paragraph num="(e)"> <text>Agreement to participate in the Maryland Long-Term Care Survey, authorized by COMAR 10.24.03.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Commission staff shall issue a determination that either CON review is not required, with or without conditions, or that CON review is required for stated reasons.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Hospital Capital Expenditures in Excess of the Hospital Capital Threshold.</text> <paragraph num="(1)"> <text>A CON is not required by a hospital before it obligates an amount exceeding the hospital capital threshold for capital expenditures for physical plant construction or renovation, or before it receives a donated physical plant whose appraised value exceeds the hospital capital threshold, under the following circumstances:</text> <paragraph num="(a)"> <text>The capital expenditure may be related to patient care.</text> </paragraph> <paragraph num="(b)"> <text>The capital expenditure does not require, over the entire period or schedule of debt service associated with the project or plant, a total cumulative increase in patient charges or hospital rates of more than $1,500,000 for the capital costs associated with the project.</text> </paragraph> <paragraph num="(c)"> <text>At least 45 days before an obligation is made or the physical plant is donated, the hospital provides notice to the Commission and to the Health Services Cost Review Commission, in the form of a written request for determination of coverage, as provided in Regulation .14A of this chapter, which shall contain the following information:</text> <paragraph num="(i)"> <text>A description of the proposed capital project, including whether it involves new construction, renovation of or additions to the existing physical plant, or the donation of a physical plant, with any necessary adaptations;</text> </paragraph> <paragraph num="(ii)"> <text>The total capital costs associated with the project;</text> </paragraph> <paragraph num="(iii)"> <text>The sources and uses of funds to be applied to the project, including hospital equity contributions, if applicable, as documented by audited financial statements of the hospital and relevant subsidiary corporations, if any, from which funds are to be taken;</text> </paragraph> <paragraph num="(iv)"> <text>A description of the financing arrangement, if applicable, for the proposed project, including the debt service schedule; and</text> </paragraph> <paragraph num="(v)"> <text>A statement by one or more persons authorized to represent the hospital that the hospital does not require a total cumulative increase in patient charges or hospital rates of more than $1,500,000 for the capital costs associated with the project.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>After consultation with the Health Services Cost Review Commission, the Commission shall issue a determination whether CON review is required within 45 days after it receives the information specified in this section. If Commission staff does not issue a determination within 60 days of receipt of all relevant financial information by the Commission and by the Health Services Cost Review Commission, the Commission is considered to have issued a determination that approval of the capital expenditure is not required by the Commission or by the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="(3)"> <text>Commission staff shall issue a determination that either CON review is not required, with or without conditions, or that CON review is required for stated reasons.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Continuation of Specific Exception from Certificate of Need for Continuing Care Retirement Communities.</text> <paragraph num="(1)"> <text>A comprehensive care facility on the campus of a continuing care retirement community is excepted from CON review, provided that the requirements of Health-General Article, §19-114(d)(2)(ii)(1), Annotated Code of Maryland, and this chapter are met, and that the number of comprehensive care beds located on the campus of the continuing care retirement community does not exceed:</text> <paragraph num="(a)"> <text>20 percent of the number of independent living units at a continuing care retirement community that has 300 or more independent living units; or</text> </paragraph> <paragraph num="(b)"> <text>24 percent of the number of independent living units at a continuing care retirement community that has fewer than 300 independent living units.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Limited Direct Admission. Notwithstanding the provisions of Health-General Article, §19-114(d)(2)(ii), Annotated Code of Maryland, a continuing care retirement community does not lose its exception from CON when the continuing care community admits an individual directly to a comprehensive care facility within the continuing care community under either of the following circumstances:</text> <paragraph num="(a)"> <text>Two individuals having a long-term significant relationship are admitted together to a continuing care retirement community and:</text> <paragraph num="(i)"> <text>The admission occurs after October 1, 1999;</text> </paragraph> <paragraph num="(ii)"> <text>The admission includes spouses, two relatives, or two individuals having a long-term significant relationship, as defined in Regulation .01B of this chapter and supported by documentary proof in existence for at least 1 year before application to the continuing care retirement community, admitted at the same time, under a joint contract, who are jointly responsible for expenses incurred under the joint contract; and</text> </paragraph> <paragraph num="(iii)"> <text>One of the individuals admitted under the joint contract will reside in an independent living unit or an assisted living unit; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An individual is admitted directly into a comprehensive care bed at a continuing care retirement community and:</text> <paragraph num="(i)"> <text>The individual must have executed a continuing care agreement and must have paid entrance fees that are at least equal to the lowest entrance fee charged by the continuing care retirement community for its independent or assisted living units;</text> </paragraph> <paragraph num="(ii)"> <text>The individual must pay the entrance fee by the same method, terms of payment, and time frame as a person who immediately assumes residence in an independent or assisted living unit at that continuing care retirement community; and</text> </paragraph> <paragraph num="(iii)"> <text>The individual admitted to the comprehensive care bed must have the potential for eventual transfer to an independent living unit or assisted living unit at that continuing care retirement community, as determined by the subscriber's personal physician, as defined in Regulation .01B of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Under §K(2)(b)(iii) of this regulation, an individual is deemed not to have potential for eventual transfer to an independent living unit or assisted living unit if the individual can qualify for hospice services under federal Medicare regulations or if the individual has an irreversible condition that would make it unlikely that the individual could transfer to an independent living unit or assisted living unit at the continuing care retirement community. Irreversible conditions include quadriplegia, ventilator dependence, and any end-stage condition.</text> </paragraph> <paragraph num="(4)"> <text>The total number of comprehensive care beds occupied by individuals who are directly admitted to comprehensive care beds pursuant to §K(2)(b) of this regulation may not exceed 20 percent of the total number of licensed and available comprehensive care beds at the continuing care retirement community.</text> </paragraph> <paragraph num="(5)"> <text>The admission of the individual directly into the comprehensive care bed pursuant to §K(2)(b) of this regulation may not cause the occupancy of the comprehensive care facility at the continuing care retirement community to exceed 95 percent of its current licensed capacity.</text> </paragraph> <paragraph num="(6)"> <text>The comprehensive care facility at the continuing care retirement community shall maintain an attestation by the individual's personal physician that the individual has the potential for eventual transfer to an independent living unit or an assisted living unit.</text> </paragraph> <paragraph num="(7)"> <text>The nursing home administrator of the comprehensive care facility at each continuing care retirement community who admits an individual directly to a comprehensive care bed pursuant to §K(2)(b) of this regulation shall maintain information, in a format specified by the Commission, about each admission in the format required by the Commission and encrypted by the continuing care retirement community so that the individual's identity will not be disclosed. The forms shall be maintained by the nursing home administrator, to be provided to Commission staff upon its request, and shall include:</text> <paragraph num="(a)"> <text>The number and utilization of licensed comprehensive care beds excluded from Certificate of Need requirements at the continuing care retirement community;</text> </paragraph> <paragraph num="(b)"> <text>The admission source of each individual admitted pursuant to §K(2)(b) of this regulation to a comprehensive care bed excluded from Certificate of Need requirements at the continuing care retirement community;</text> </paragraph> <paragraph num="(c)"> <text>For an individual admitted pursuant to §K(2)(b) of this regulation, the amount of and terms of payment for the entrance fee;</text> </paragraph> <paragraph num="(d)"> <text>The dates of admission and discharge of each individual admitted pursuant to §K(2)(b) of this regulation;</text> </paragraph> <paragraph num="(e)"> <text>The site to which an individual directly admitted pursuant to §K(2)(b) of this regulation is discharged; and</text> </paragraph> <paragraph num="(f)"> <text>Any other information as required by Commission staff.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Exemption from Certificate of Need Review."> <paragraph num="A."> <text>The Commission may exempt from the requirement of CON review and approval the following actions:</text> <paragraph num="(1)"> <text>Merger or consolidation of two or more hospitals or other health care facilities, if the facilities or an organization that operates the facilities give the Commission 45 days written notice of their intent to merge or consolidate;</text> </paragraph> <paragraph num="(2)"> <text>Relocation of an existing health care facility owned or controlled by a merged asset system, if:</text> <paragraph num="(a)"> <text>The relocation is to a site outside:</text> <paragraph num="(i)"> <text>The primary service area of the hospital to be relocated but within the primary service area of the merged asset system; or</text> </paragraph> <paragraph num="(ii)"> <text>The service area of the non-hospital health care facility to be relocated but within the primary service area of the merged asset system; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The relocation of the existing health care facility does not:</text> <paragraph num="(i)"> <text>Change the type or scope of health care services offered; and</text> </paragraph> <paragraph num="(ii)"> <text>In the case of a hospital, require a capital expenditure for its construction that exceeds the hospital capital threshold, adjusted for inflation, except as provided by Regulation .03J of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A change in the bed capacity of an existing health care facility pursuant to the consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use, except as provided in Regulation .03F of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>A change in the type or scope of the health care services offered by a health care facility, if, at least 45 days before increasing or decreasing the volume of one or more health care services, the Commission finds that the proposed change is pursuant to the:</text> <paragraph num="(a)"> <text>Consolidation or merger of two or more health care facilities;</text> </paragraph> <paragraph num="(b)"> <text>Conversion of all or part of a health care facility to a non-health-related use; or</text> </paragraph> <paragraph num="(c)"> <text>Conversion of a hospital to a limited service hospital;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A capital expenditure that exceeds the review threshold for capital expenditure made as part of a consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use; or</text> </paragraph> <paragraph num="(6)"> <text>The establishment of a freestanding medical facility through the conversion of an acute general hospital, as provided in §F of this regulation and in COMAR 10.24.19.04C.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless otherwise provided in this chapter for a specific type of health care facility, complete notice of intent to seek exemption from CON review shall be filed with the Commission at least 45 days before the intended action, and shall include:</text> <paragraph num="(1)"> <text>The name and location of each affected health care facility;</text> </paragraph> <paragraph num="(2)"> <text>A general description of the proposed project including, in the case of mergers and consolidations, any proposed:</text> <paragraph num="(a)"> <text>Conversion, expansion, relocation, or reduction of one or more health care services;</text> </paragraph> <paragraph num="(b)"> <text>Renovation of existing facilities;</text> </paragraph> <paragraph num="(c)"> <text>New construction;</text> </paragraph> <paragraph num="(d)"> <text>Relocation or reconfiguration of existing medical services; or</text> </paragraph> <paragraph num="(e)"> <text>Change in bed capacity at each affected facility;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The scheduled date of the project's completion;</text> </paragraph> <paragraph num="(4)"> <text>Identification of each outstanding public obligation;</text> </paragraph> <paragraph num="(5)"> <text>Information demonstrating that the project:</text> <paragraph num="(a)"> <text>Is not inconsistent with the State Health Plan;</text> </paragraph> <paragraph num="(b)"> <text>Will result in the delivery of more efficient and effective delivery of health care services; and</text> </paragraph> <paragraph num="(c)"> <text>Is in the public interest; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Any other information, analyses, or other requirements established in State Health Plan regulation for requests seeking exemption from CON review.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice by the Commission to the Public, Elected Officials, and Other State Agencies.</text> <paragraph num="(1)"> <text>Within 5 days after it receives a complete Notice of Intent from a health care facility seeking exemption from CON review, the Commission shall publish notice of its receipt:</text> <paragraph num="(a)"> <text>In at least one newspaper of general circulation in the affected area;</text> </paragraph> <paragraph num="(b)"> <text>In the next available issue of the Maryland Register; and</text> </paragraph> <paragraph num="(c)"> <text>On the Commission’s website.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Commission shall mail the same notice to elected public officials in whose district or jurisdiction the exemption from CON review is proposed.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall solicit comment from the affected public, in evaluating whether the action or project proposed for exemption from CON review is in the public interest.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Public Informational Hearing.</text> <paragraph num="(1)"> <text>An acute general hospital shall hold a public informational hearing in the jurisdiction where it is located within 30 days after it has filed with the Commission notice of its intent to:</text> <paragraph num="(a)"> <text>Close;</text> </paragraph> <paragraph num="(b)"> <text>Partially close, if the hospital is located in a jurisdiction with fewer than three acute general hospitals; or</text> </paragraph> <paragraph num="(c)"> <text>Convert to a limited service hospital or freestanding medical facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before holding the public informational hearing, the hospital shall consult with the Commission, to ensure that:</text> <paragraph num="(a)"> <text>Within 5 days of notifying the Commission of its intent to close, partially close, or convert, the hospital has provided public notice of the proposed closure or conversion and of the time and location of the required public informational hearing and how the public can electronically obtain additional information, including publication in at least one newspaper of general circulation in the affected area; and</text> </paragraph> <paragraph num="(b)"> <text>The public hearing will address the information required by §D(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Requirements for a Public Informational Hearing.</text> <paragraph num="(a)"> <text>The acute general hospital proposing to close, partially close, or convert to a limited service hospital or freestanding medical facility shall hold a public informational hearing at the hospital or if that is not feasible at a public meeting area near the hospital.</text> </paragraph> <paragraph num="(b)"> <text>The hospital shall post a notice of the public informational hearing in public areas of its facility and on the landing page of its website.</text> </paragraph> <paragraph num="(c)"> <text>The hospital shall identify to the public the names of the senior management and Board of Directors attending the hearing;</text> </paragraph> <paragraph num="(d)"> <text>The hospital shall present at least the following information at the public informational hearing:</text> <paragraph num="(i)"> <text>The reasons for the closure, partial closure, or conversion;</text> </paragraph> <paragraph num="(ii)"> <text>The plan for transitioning acute care services previously provided by the hospital to residents of the hospital service area;</text> </paragraph> <paragraph num="(iii)"> <text>The plan for addressing the health care needs of the residents of the hospital service area;</text> </paragraph> <paragraph num="(iv)"> <text>The plan for retraining and placing displaced employees;</text> </paragraph> <paragraph num="(v)"> <text>The plan for the hospital’s physical plant and site; and</text> </paragraph> <paragraph num="(vi)"> <text>The proposed timeline for the closure, partial closure, or conversion to a freestanding medical facility.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The public informational hearing shall be recorded.</text> </paragraph> <paragraph num="(f)"> <text>Within 10 business days after the public informational hearing, the hospital shall make available on its website a recording of the public informational hearing and provide a written summary of the hearing, which shall also be provided to:</text> <paragraph num="(i)"> <text>The Governor;</text> </paragraph> <paragraph num="(ii)"> <text>The Secretary;</text> </paragraph> <paragraph num="(iii)"> <text>The governing body of the jurisdiction in which the hospital is located;</text> </paragraph> <paragraph num="(iv)"> <text>The local health department and the local board of health or similar body for the jurisdiction in which the hospital is located;</text> </paragraph> <paragraph num="(v)"> <text>The Commission; and</text> </paragraph> <paragraph num="(vi)"> <text>Subject to State Government Article, §2-1257, Annotated Code of Maryland, the Senate Finance Committee, the House Health and Government Operations Committee, and the members of the General Assembly who represent the district in which the hospital is located.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Commission Action.</text> <paragraph num="(1)"> <text>Unless otherwise provided in this chapter for a specific type of health care facility, the Commission shall issue an exemption from CON review to the health care facility or the merged asset system seeking this determination within 45 days after it receives the notice of intent required by §B of this regulation, if:</text> <paragraph num="(a)"> <text>The facility or system has provided the information required by the notice of intent, and has held a public informational hearing if required by §D of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The Commission, in its sole discretion, finds that the action proposed:</text> <paragraph num="(i)"> <text>Is not inconsistent with the State Health Plan or an institution-specific plan developed by the Commission under Health-General Article, §19-119, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Will result in more efficient and effective delivery of health care services; and</text> </paragraph> <paragraph num="(iii)"> <text>Is in the public interest.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For any project that the Commission may exempt from CON review under §A of this regulation, for which a final Commission decision has not been issued within 45 days after it receives a complete notice of intent as required by §B of this regulation, Commission staff shall provide a status report at the next Commission meeting and any subsequent Commission meeting stating the reasons for the delay and the expected time frame for issuing its final decision.</text> </paragraph> <paragraph num="(3)"> <text>CON review is not required and the exemption request shall be deemed approved for any project which the Commission may exempt from CON review under §A of this regulation if final action by the Commission does not occur within 90 days after the facility or system has provided complete notice of intent as required by §B of this regulation and has held a public hearing if required by §D of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Upon request, Commission staff shall provide written confirmation that an exemption request has been deemed approved in accordance with §E(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Freestanding Medical Facility.</text> <paragraph num="(1)"> <text>In accordance with COMAR 10.24.19.04C and this regulation, the Commission may exempt from CON review the establishment of a freestanding medical facility as a result of a conversion from a licensed acute general hospital.</text> </paragraph> <paragraph num="(2)"> <text>At least 60 days before the conversion, written notice of intent to convert the licensed general hospital to a freestanding medical facility shall be filed with the Commission in accordance with COMAR 10.24.19.04C.</text> </paragraph> <paragraph num="(3)"> <text>Provided that all the requirements of this regulation and COMAR 10.24.19.04C are met, the Commission shall grant the exemption if it finds, in its sole discretion, that the conversion:</text> <paragraph num="(a)"> <text>Is consistent with the State Health Plan;</text> </paragraph> <paragraph num="(b)"> <text>Will result in the delivery of more efficient and effective health care services;</text> </paragraph> <paragraph num="(c)"> <text>Will maintain adequate and appropriate delivery of emergency care within the statewide emergency medical services system as determined by the State Emergency Medical Services Board; and</text> </paragraph> <paragraph num="(d)"> <text>Is in the public interest.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Commission may approve, approve with conditions, or deny the requested exemption.</text> </paragraph> <paragraph num="(5)"> <text>Failure to maintain compliance with conditions on an exemption or with the time frame for completion of the conversion may result in withdrawal of the exemption issued by the Commission in accordance with Regulation .12 of this chapter. An exemption holder may request approval of a reasonable modification to the conversion timeline in accordance with Regulation .12A(4) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Ambulatory Surgery Centers: Determination of Coverage and Data Reporting."> <paragraph num="A."> <text>Determination of Coverage.</text> <paragraph num="(1)"> <text>A CON is not required for an ambulatory surgery center.</text> </paragraph> <paragraph num="(2)"> <text>A person shall obtain a determination of coverage from the Commission before:</text> <paragraph num="(a)"> <text>Establishing a new ambulatory surgery center;</text> </paragraph> <paragraph num="(b)"> <text>Adding a new operating room or any other rooms in which procedures are performed to an existing ambulatory surgery center; or</text> </paragraph> <paragraph num="(c)"> <text>Making any change in the information provided for initial determination of coverage.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Change in Location. A determination of coverage for an ambulatory surgery center is issued only for the exact address specified in the determination. A change in address or in the layout of the center before it is built, developed, or established requires a new determination of coverage.</text> </paragraph> <paragraph num="(4)"> <text>Change in Ownership. A determination of coverage regarding an ambulatory surgery center is issued only for the person specified in the determination. If the principal owner or a majority of other owners of an existing ambulatory surgery center is expected to change, a request for a new determination of coverage shall be filed and include:</text> <paragraph num="(a)"> <text>A complete list of the existing owners and the post-transaction owners; and</text> </paragraph> <paragraph num="(b)"> <text>An attestation by the ambulatory surgery center that, subsequent to the issuance of the original determination of coverage, no changes have been made and that, as a result of the planned change in ownership, no changes will be made:</text> <paragraph num="(i)"> <text>To the physical plant or layout of the ambulatory surgery center; or</text> </paragraph> <paragraph num="(ii)"> <text>In the surgical specialties provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Expiration of Determination of Coverage. A determination of coverage for a new ambulatory surgery center or for new capacity at an existing ASC-P or ASC-1 may be issued and is effective for 2 years from the date of the determination. If that capacity is not built or established within 2 years, the determination of coverage is void.</text> </paragraph> <paragraph num="(6)"> <text>Notice. Before seeking to establish a new operating room or any other rooms in which procedures are performed, or to make any change in the information provided for initial determination of coverage, a person shall provide notice to the Commission at least 45 days in advance that includes all information required by COMAR 10.24.11.04A.</text> </paragraph> <paragraph num="(7)"> <text>For purposes of this regulation, all ambulatory surgery centers that are located in the same building and that share any common ownership or control shall be considered one entity, and their operating rooms shall be considered together for purposes of determining coverage under Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>Except as provided in this regulation or permitted in the Certificate of Need or exemption criteria in the State Health Plan under COMAR 10.24.11, an ambulatory surgical facility or other entity primarily providing ambulatory surgical services may not relocate beyond an adjacent site or expand its number of operating rooms without obtaining a Certificate of Need.</text> </paragraph> <paragraph num="(9)"> <text>A CON is not required for ambulatory surgical services provided as part of an office of one or more individuals licensed to practice dentistry under Health-Occupations Article, Title 4, Annotated Code of Maryland, for the purpose of practicing dentistry, if the ambulatory surgical facility is not used in a medical practice other than dentistry.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Data Reporting and Annual Survey of Ambulatory Surgical Centers, Facilities, and Providers.</text> <paragraph num="(1)"> <text>To provide information for the Commission's planning purposes and to determine changes in circumstances and operation that may affect coverage by CON requirements, each existing ambulatory surgery center, facility, office, and provider that primarily provides ambulatory surgical services shall annually provide to the Commission the information required by COMAR 10.24.04.</text> </paragraph> <paragraph num="(2)"> <text>A person providing ambulatory surgical services who is required to obtain a license under Health-General Article, §19-3B-02(a), Annotated Code of Maryland, shall annually provide the required information on a form provided by the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Access to Information and Facilities."> <text>To the extent permitted by law, an applicant shall provide access to general information, records, plans and specifications, meetings, sites, and facilities to Commission staff upon proper notice and as is reasonable and necessary in the performance of the Commission's responsibilities. The Commission may require other health care providers to provide similar information.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Preapplication Procedures."> <paragraph num="A."> <text>Letter of Intent.</text> <paragraph num="(1)"> <text>A prospective applicant for a Certificate of Need shall submit to the Center for Health Care Facilities Planning and Development a brief letter of intent, with a copy to each local health department in the health planning region. The Center for Health Care Facilities Planning and Development shall formally log all letters of intent upon receipt.</text> </paragraph> <paragraph num="(2)"> <text>A prospective applicant identified in a letter of intent may be the person or persons who will be the licensee. If the legal entity that will be the licensee has not yet been formed or finalized at the time of filing a letter of intent:</text> <paragraph num="(a)"> <text>A prospective applicant shall identify the intended ownership and control of the licensee with the same level of specificity as required in §A(3) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>The legal entity that will be the licensee shall be formed at the time of filing an application for a CON.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The letter of intent shall include the following information:</text> <paragraph num="(a)"> <text>The identity of each person on whose behalf the letter of intent is filed, including:</text> <paragraph num="(i)"> <text>The name and address of each such person; and</text> </paragraph> <paragraph num="(ii)"> <text>In the case of a letter of intent filed on behalf of a person that is not a natural person, the date the entity was formed, the business address of the entity, and the identity and percentage of ownership of all persons having an ownership interest of 5 percent or more in the entity;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A description of the proposed project;</text> </paragraph> <paragraph num="(c)"> <text>The quantity and types of beds or health services involved; and</text> </paragraph> <paragraph num="(d)"> <text>The specific location and each jurisdiction in which services will be provided, according to the relevant planning region in the State Health Plan for that facility or service.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A letter of intent shall be submitted in accordance with the published review schedule established by the Commission in accordance with Regulation .08D of this chapter, but if no applicable review schedule has been published, a letter of intent may be submitted at any time.</text> </paragraph> <paragraph num="(5)"> <text>Notice of the receipt of a letter of intent for a project not subject to a published review schedule shall be placed in the Maryland Register, and a 30-day period initiated for the submission of any other letters of intent for comparable projects to be included in a comparative review.</text> </paragraph> <paragraph num="(6)"> <text>Upon docketing of an application, the letter of intent for that project is no longer valid for purposes of comparative review.</text> </paragraph> <paragraph num="(7)"> <text>If a letter of intent is submitted for a proposed health care project which might be comparable to a project application which has been submitted but not yet docketed, the projects shall be given a comparative review.</text> </paragraph> <paragraph num="(8)"> <text>Notwithstanding any other regulation in this chapter, no letter of intent or application shall initiate a comparative review with an earlier filed letter of intent or application if the earlier filed letter of intent predates the later filed letter of intent by a period of more than 60 days, unless the Executive Director finds that the applicant in the earlier filed matter has unreasonably delayed in the advancement of its application through staff’s completeness review, and that good cause exists to review the projects in comparative review.</text> </paragraph> <paragraph num="(9)"> <text>If a person submits a letter of intent for a proposed health care project that might be comparable to an application which has already been docketed, a comparative review may not be conducted.</text> </paragraph> <paragraph num="(10)"> <text>If an application for a CON is not filed in accordance with Regulation .08A(1) of this chapter, the letter of intent is void.</text> </paragraph> <paragraph num="(11)"> <text>Letters of intent are subject to public inspection during normal business hours.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Preapplication Conference. After the filing of a letter of intent, an applicant may request that the Commission staff arrange a preapplication conference to discuss:</text> <paragraph num="(1)"> <text>Commission procedures for reviewing the application or applications;</text> </paragraph> <paragraph num="(2)"> <text>Information and data to be included in the application or applications;</text> </paragraph> <paragraph num="(3)"> <text>The State Health Plan requirements that may affect the project; and</text> </paragraph> <paragraph num="(4)"> <text>Other matters relevant to the filing and processing of the application or applications.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The discussions in §B of this regulation are informal, and statements at the meetings are not admissible as evidence at a Commission proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Procedure for Review of CON Applications."> <paragraph num="A."> <text>Review Schedule.</text> <paragraph num="(1)"> <text>An application shall be submitted in accordance with the published review schedule established by the Commission in accordance with §D(1) of this regulation, but if no applicable review schedule has been published, an application may be submitted at any time 60 days after the filing of the letter of intent but no more than 180 days after the filing of the letter of intent, unless a shorter period has been approved by the Executive Director.</text> </paragraph> <paragraph num="(2)"> <text>In a case when need for additional service capacity is projected, the Commission may not docket an application until it has made a final decision on each previously docketed application for a comparable project, unless the most recently published need projections or State Health Plan would support the approval of both projects.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Submission of Application.</text> <paragraph num="(1)"> <text>An application for a CON shall be submitted to the Commission's Center for Health Care Facilities Planning and Development in the form and manner prescribed by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The application, and all information supplementing the application, shall be signed by at least one principal of the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of the application (or the supplementary information) are true to the best of my knowledge, information, and belief.”</text> </paragraph> </paragraph> <paragraph num="C."> <text>Completeness Review and Docketing.</text> <paragraph num="(1)"> <text>Prior to docketing an application for review, Commission staff shall review the application for completeness:</text> <paragraph num="(a)"> <text>Within 20 business days for projects involving the establishment of a health care facility, the relocation of a health care facility or the introduction by a hospital of cardiac surgery or organ transplantation; and</text> </paragraph> <paragraph num="(b)"> <text>Within 15 business days for all other projects.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Commission staff may schedule a conference with the applicant within the completeness review period prescribed in §C(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Commission staff shall determine whether the application contains all the information requested in the application. If staff determines that the application is not complete, the staff shall make one written request for additional information that specifies the information requested and the 15-business-day deadline for the applicant to supply the requested information. For good cause, staff may make one additional request for information, to which the applicant shall have 10 business days to respond. Additional information may be requested by staff beyond that required to make the application complete, which shall also be subject to a time limit for the applicant to supply the requested information.</text> </paragraph> <paragraph num="(4)"> <text>If Commission staff determines, based on staff’s review of the application and any additional information provided in response to a staff request for additional information, that the application is complete and conforms with the applicable docketing rules in the State Health Plan, the staff shall docket the application for review and publish notice of the docketing on the next available publication date of the Maryland Register.</text> </paragraph> <paragraph num="(5)"> <text>If an applicant fails to supply the required information within the specified time limit, staff may dismiss the application. Staff may, at its discretion, extend the response time for an applicant in a noncomparative review, or, with the consent of all applicants, for an applicant in a comparative review, up to an additional 10 business days, or more upon a demonstration of good cause for the additional extension.</text> </paragraph> <paragraph num="(6)"> <text>Commission staff or a reviewer may:</text> <paragraph num="(a)"> <text>Request information from the applicant supplementing an otherwise complete application at any time during the review of an application; and</text> </paragraph> <paragraph num="(b)"> <text>Set reasonable time limits for the applicant to supply the requested information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notice to the Public.</text> <paragraph num="(1)"> <text>At least once each year, Commission staff shall publish in the Maryland Register a schedule for conducting reviews of applications for designated services by health planning region, as follows:</text> <paragraph num="(a)"> <text>The schedule shall include the status of applicable need forecasts found in the State Health Plan or published elsewhere as required by the State Health Plan for conducting the reviews of the designated services by health planning region;</text> </paragraph> <paragraph num="(b)"> <text>The schedule shall establish application submission dates not sooner than 3 months following the publication of the proposed schedule; and</text> </paragraph> <paragraph num="(c)"> <text>The schedule shall identify scheduled reviews by health planning region and shall state the dates for the receipt of letters of intent and the submission of applications.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 10 business days of receiving a complete application, Commission staff shall request that the Maryland Register publish notice to the public of the docketing of an application. The Commission shall also publish notice in a newspaper of general circulation in the area of the proposed project. Notices shall comply with State Government Article, §10-207, Annotated Code of Maryland, and shall include:</text> <paragraph num="(a)"> <text>A citation to the Commission's enabling act and this chapter, the name of the applicant, the matter or docket number, and a general description of the project containing the information required in letters of intent;</text> </paragraph> <paragraph num="(b)"> <text>An explanation that a person who meets the definition of “interested party” in Regulation .01B of this chapter may become an interested party to the review of this application by submitting written comments on the application within 30 days of its docketing; and</text> </paragraph> <paragraph num="(c)"> <text>A statement that a person may request in writing that the Commission advise them of further notices of the proceedings on the application, and that any further notice of proceedings will only be sent to persons who have submitted a written request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Commission shall provide notice to each person who has requested to be apprised of further proceedings on the application.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Modifications to Letters of Intent and Applications.</text> <paragraph num="(1)"> <text>An applicant shall give written notice to the Center for Health Care Facilities Planning and Development of any modifications to the applicant's letter of intent before submitting an application.</text> </paragraph> <paragraph num="(2)"> <text>An application may be modified until the 45th day after docketing. After the 45th day of docketing, an application may only be modified as a result of a project status conference held pursuant to Regulation .09A(2) of this chapter or upon a showing of good cause.</text> </paragraph> <paragraph num="(3)"> <text>If an application is modified:</text> <paragraph num="(a)"> <text>The Commission shall provide:</text> <paragraph num="(i)"> <text>Notice of the changes by a dated posting on the Commission's website and in a newspaper of general circulation in the affected jurisdiction; and</text> </paragraph> <paragraph num="(ii)"> <text>A 10-business-day period following the website posting for comments on the changes; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Each applicant in the review will be deemed to have waived the right to a final decision by the Commission within the statutorily prescribed time.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The following modifications to a proposed project require a new Certificate of Need application:</text> <paragraph num="(a)"> <text>Changes in the fundamental nature of a proposed facility or the medical services to be provided;</text> </paragraph> <paragraph num="(b)"> <text>Increases in the total bed capacity of a proposed facility; or</text> </paragraph> <paragraph num="(c)"> <text>A change in the site of a proposed facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Comments by a Person Seeking Interested Party Status or by a Participating Entity and Applicant's Response.</text> <paragraph num="(1)"> <text>Written Comments by a Person Seeking Interested Party Status.</text> <paragraph num="(a)"> <text>A person seeking interested party status shall file written comments on an application within 30 days of docketing.</text> </paragraph> <paragraph num="(b)"> <text>The comments shall include information sufficient to establish interested party status, as defined in Regulation .01B of this chapter.</text> </paragraph> <paragraph num="(c)"> <text>If a person seeking interested party status is opposing an application, the comments shall state with particularity the State Health Plan standards or the review criteria in §G of this regulation that the person seeking interested party status believes have not been met by the applicant and the reasons why the applicant does not meet those standards or criteria.</text> </paragraph> <paragraph num="(d)"> <text>Factual assertions made in comments by a person seeking interested party status that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit.</text> </paragraph> <paragraph num="(e)"> <text>In a review with only one applicant, the comments shall be 25 pages or fewer, double-spaced, excluding attachments.</text> </paragraph> <paragraph num="(f)"> <text>In a comparative review, the comments shall be 35 pages or fewer, double-spaced, excluding attachments.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Written Comments by a Person Seeking Participating Entity Status.</text> <paragraph num="(a)"> <text>A person seeking participating entity status shall file written comments on an application within 30 days of docketing that:</text> <paragraph num="(i)"> <text>Include information that the participating entity wishes the Commission to consider; and</text> </paragraph> <paragraph num="(ii)"> <text>State with particularity the State Health Plan standards or review criteria in §G of this regulation that it believes have not been met by the applicant, and the reasons why the applicant does not meet those standards or criteria.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A person granted participating entity status shall be copied on Commission documents in the review of the application.</text> </paragraph> <paragraph num="(c)"> <text>A person granted participating entity status is not an interested party and has no right to judicial review of a final Commission decision.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Response to Comments.</text> <paragraph num="(a)"> <text>An applicant is permitted to make one written filing responding to all written comments on its application within 15 days of receipt of those comments.</text> </paragraph> <paragraph num="(b)"> <text>The applicant’s response may not be more than 25 pages, double-spaced, excluding attachments.</text> </paragraph> <paragraph num="(c)"> <text>In a comparative review, the applicant’s response may not be more than 35 pages, double-spaced, excluding attachments.</text> </paragraph> <paragraph num="(d)"> <text>Factual assertions in an applicant's response that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Criteria for Review of Application.</text> <paragraph num="(1)"> <text>In a Certificate of Need review, the applicant carries the burden of proving by a preponderance of the evidence that the project meets the applicable criteria for review.</text> </paragraph> <paragraph num="(2)"> <text>In reviewing an application for a CON, the Commission shall consider the applicant's submissions, the comments, if any, of interested parties, participating entities, the local health department, and information gathered during the Commission’s review of the application, to which each applicant and interested party has been afforded the opportunity to respond. In a comparative review the Commission shall award a CON to the applicant, or applicants, that best meet the review criteria in §G(3) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Criteria for Review of an Application for Certificate of Need.</text> <paragraph num="(a)"> <text>State Health Plan. An application for a Certificate of Need shall be evaluated according to all relevant State Health Plan standards.</text> </paragraph> <paragraph num="(b)"> <text>Need. The Commission shall consider the applicable need analysis in the State Health Plan. If no State Health Plan need analysis is applicable, the Commission shall consider whether the applicant has demonstrated a need for the proposed project.</text> </paragraph> <paragraph num="(c)"> <text>Alternatives to the Project. The Commission shall consider the alternative approaches to meeting the need identified for the project that were considered by the applicant in planning the project and the basis for the applicant’s choice of the project among considered alternatives. In a comparative review of applications within the same review cycle, the Commission shall compare the costs and the likely effectiveness of alternative projects in meeting identified needs, improving the availability and accessibility of care, and improving the quality of care.</text> </paragraph> <paragraph num="(d)"> <text>Project Financial Feasibility and Facility or Program Viability. The Commission shall consider the availability of resources necessary to implement the project and the availability of revenue sources and demand for the proposed services adequate to ensure ongoing viability and sustainability of the facility to be established or modified or the service to be introduced or expanded.</text> </paragraph> <paragraph num="(e)"> <text>Compliance with Terms and Conditions of Previous Certificates of Need. An applicant shall demonstrate compliance with all terms and conditions of each previous CON granted to the applicant.</text> </paragraph> <paragraph num="(f)"> <text>Project Impact. The Commission shall consider the impact of the proposed project on the costs and charges of existing providers of the facilities and services included in the project and on access to those facilities and services in the service area of the project.</text> </paragraph> <paragraph num="(g)"> <text>Health Equity. The Commission shall consider how a proposed project will address health care disparities in availability, accessibility, and quality of care among different populations within the service area. The Commission shall consider how social determinants of health within the service area of the proposed project create disparities in the delivery of health care.</text> </paragraph> <paragraph num="(h)"> <text>Character and Competence. The Commission shall assess the character and competence of an applicant based upon experience and past performance, including any records of violation in operating a health care service or facility.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Commission Decision and Action on CON Applications."> <paragraph num="A."> <text>Proposed Decision.</text> <paragraph num="(1)"> <text>Preparation of Proposed Decision.</text> <paragraph num="(a)"> <text>In a comparative or contested review, or in a review in which an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Executive Director shall appoint a single Commissioner, who may be assisted by the staff of the Commission, to act as reviewer and prepare a proposed decision for consideration by the Commission.</text> </paragraph> <paragraph num="(b)"> <text>In all other reviews, Commission staff shall review the application and prepare a staff report and recommendation for consideration by the Commission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Project Status Conference.</text> <paragraph num="(a)"> <text>The reviewer or staff, as appropriate, may request that a project status conference be held before the issuance of a proposed decision or staff report, to apprise each applicant, interested party, and participating entity of those aspects of a proposed project that appear to be inconsistent with applicable standards and review criteria.</text> </paragraph> <paragraph num="(b)"> <text>Following the project status conference, the reviewer or staff will send each applicant, interested party, and participating entity a summary of the project status conference that includes dates, as needed, for additional filings.</text> </paragraph> <paragraph num="(c)"> <text>The applicant shall send to each interested party and participating entity a copy of proposed project changes made pursuant to the project status conference.</text> </paragraph> <paragraph num="(d)"> <text>Each interested party and participating entity in the review of an application shall have 7 days to file comments on the proposed changes made pursuant to the project status conference.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Opportunity to Present Oral Argument. Each applicant and interested party in a contested or comparative review may request the opportunity to present oral argument to the reviewer before the reviewer prepares a proposed decision on the application for consideration by the full Commission, as follows:</text> <paragraph num="(a)"> <text>The request shall be made within the time period for an applicant's response to comments under Regulation .08F(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The decision to grant oral argument is at the sole discretion of the reviewer;</text> </paragraph> <paragraph num="(c)"> <text>The reviewer may set reasonable time limits for oral argument; and</text> </paragraph> <paragraph num="(d)"> <text>The reviewer may, if there is a genuine dispute as to the credibility of a material witness on a matter of fact, require the witness to answer questions on that matter under oath during the oral argument portion of a CON review.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A staff report and recommendation on a proposed project or a reviewer’s proposed decision on a project shall state the staff’s conclusion or the reviewer's finding as to whether:</text> <paragraph num="(a)"> <text>Each relevant State Health Plan standard or review criterion set forth in Regulation .08G of this chapter:</text> <paragraph num="(i)"> <text>Is met by the applicant;</text> </paragraph> <paragraph num="(ii)"> <text>Is not applicable to the project; or</text> </paragraph> <paragraph num="(iii)"> <text>Is applicable to the project and is not met by the applicant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In a comparative review, one or more of the projects is preferred under a State Health Plan standard or criterion either as a result of consideration of a preference standard or because one or more of the projects was determined to be superior based on the reviewer’s consideration of the applicable criteria; and</text> </paragraph> <paragraph num="(c)"> <text>To recommend that one or more of the projects be granted a CON.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Exceptions.</text> <paragraph num="(1)"> <text>Pursuant to State Government Article, §10-216, Annotated Code of Maryland, each applicant and interested party who has submitted comments under Regulation .08F(1) of this chapter may submit written exceptions to a staff report and recommendation or a proposed decision and make oral argument to the Commission.</text> </paragraph> <paragraph num="(2)"> <text>Schedule.</text> <paragraph num="(a)"> <text>A proposed decision in a contested or comparative review shall be issued at least 30 days before the Commission meeting at which the proposed decision and order will be considered.</text> </paragraph> <paragraph num="(b)"> <text>Upon issuance of a staff report or proposed decision, Commission staff shall issue a notice specifying the schedule for the submission of exceptions and any response, the date on which the Commission shall hear oral argument, and rules for conduct of the hearing.</text> </paragraph> <paragraph num="(c)"> <text>Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff in a contested or comparative review shall specify that exceptions shall be filed on a date at least 10 days after the issuance of a proposed decision and any response to the exceptions filed on a date at least 7 days after the filing of exceptions. The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Exceptions Requirements.</text> <paragraph num="(a)"> <text>Exceptions shall specifically identify each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based.</text> </paragraph> <paragraph num="(b)"> <text>Exceptions shall be limited to 25 pages, double-spaced, excluding attachments.</text> </paragraph> <paragraph num="(c)"> <text>Responses to exceptions shall be limited to 15 pages, double-spaced, excluding attachments.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Oral arguments before the full Commission concerning the proposed decision are limited to 10 minutes per applicant and 10 minutes per interested party, unless extended by the Chair of the Commission. An applicant may reserve time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Participation By Participating Entity In Certain Reviews After Issuance of a Staff Report or Reviewer's Proposed Decision.</text> <paragraph num="(1)"> <text>Request by Participating Entity to Address the Commission.</text> <paragraph num="(a)"> <text>After the issuance of a staff report or a reviewer's proposed decision, a participating entity may request the opportunity to address the Commission before Commission action on the application by submitting a written request at least 7 days before the scheduled Commission meeting that will consider an application, specifying the points that it wants to make.</text> </paragraph> <paragraph num="(b)"> <text>The Chair of the Commission, after consultation with the Executive Director, may permit a participating entity, or combination of participating entities, to make an oral presentation to the Commission on matters it addressed in written comments on the application.</text> </paragraph> <paragraph num="(c)"> <text>At least 5 days before the scheduled Commission meeting that will consider an application, the Executive Director shall advise each applicant, interested party, and participating entity in a review whether the Chair will permit a participating entity or combination of participating entities to make an oral presentation to the Commission, and shall specify the format of the presentation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant may address the Commission in any review in which a participating entity is granted permission to address the Commission before action on an application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Final Decision.</text> <paragraph num="(1)"> <text>The Commission's final decision on a project shall contain findings of fact and conclusions of law and:</text> <paragraph num="(a)"> <text>Approve the application;</text> </paragraph> <paragraph num="(b)"> <text>Approve the application with conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The decision of the Commission shall be by a majority of the quorum present and voting.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Action on the Application.</text> <paragraph num="(1)"> <text>The Commission shall act on an application for a CON not later than 150 days after the application has been docketed. If no evidentiary hearing is held, the Commission shall act on an application within 90 days after the docketing of the application. Staff shall report to the Commission the status of all projects where a staff report is not issued for Commission action within 90 days.</text> </paragraph> <paragraph num="(2)"> <text>With the exception of CON applications to establish a health care facility, relocate a health care facility, or establish cardiac surgery services or organ transplantation services at an existing acute general hospital, a CON application filed after October 1, 2019 shall be deemed approved if the application is uncontested and final action by the Commission does not occur within 120 days after the application is docketed.</text> </paragraph> <paragraph num="(3)"> <text>On motion by an applicant or an interested party, a review of a CON application may be stayed for a period not to exceed 6 months if the reviewer, or if a reviewer is not appointed, the Executive Director, determines that there is good cause for a stay.</text> </paragraph> <paragraph num="(4)"> <text>The Commission shall notify the applicant, interested parties, participating entities, and the local health department of the Commission’s final decision.</text> </paragraph> <paragraph num="(5)"> <text>The Commission may not render a final decision until:</text> <paragraph num="(a)"> <text>A staff report and recommendation or a reviewer’s proposed decision has been provided to each party; and</text> </paragraph> <paragraph num="(b)"> <text>Each applicant and interested party has been given an opportunity to file exceptions and present oral argument before the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Judicial Review.</text> <paragraph num="(1)"> <text>The Commission's final decision is subject to judicial review under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>In order to seek judicial review, a party must be an aggrieved party.</text> </paragraph> <paragraph num="(3)"> <text>For purposes of judicial review, the record of the proceeding shall include:</text> <paragraph num="(a)"> <text>The application;</text> </paragraph> <paragraph num="(b)"> <text>Requests to an applicant for additional information from Commission staff, the reviewer, the Commission, and responses to the requests;</text> </paragraph> <paragraph num="(c)"> <text>Comments received from each interested party and responses from each applicant;</text> </paragraph> <paragraph num="(d)"> <text>Reports or recommendations from staff;</text> </paragraph> <paragraph num="(e)"> <text>Motions and responsive filings;</text> </paragraph> <paragraph num="(f)"> <text>The prehearing conference report, if any;</text> </paragraph> <paragraph num="(g)"> <text>Prefiled testimony, if any;</text> </paragraph> <paragraph num="(h)"> <text>A recording or transcript of any hearing;</text> </paragraph> <paragraph num="(i)"> <text>The reviewer's proposed decision, all exceptions, and responses to exceptions; and</text> </paragraph> <paragraph num="(j)"> <text>The Commission's final decision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A decision of the Commission is a final decision for purposes of judicial review.</text> </paragraph> <paragraph num="(5)"> <text>A request for reconsideration in accordance with Regulation .19 of this chapter will stay the final decision of the Commission for purposes of judicial review until the Commission decides the request for reconsideration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Miscellaneous Rules and Procedures."> <paragraph num="A."> <text>Computation of Time.</text> <paragraph num="(1)"> <text>In computing a period of time prescribed by these regulations, by order of the Commission, or by an applicable statute, the day of the action or default initiating the designated period of time is not included. The last day of the period so computed is to be included unless it is a day on which the office of the Commission is closed, in which event the period extends until the next day on which the office of the Commission is open. Unless otherwise noted, all time periods shall be computed in calendar days.</text> </paragraph> <paragraph num="(2)"> <text>At the discretion of the reviewer, the Executive Director, or the Executive Director's designee, and upon a showing of good cause by the submitting party, a period of time to submit a document or perform any act permitted or prescribed by these regulations may be extended for a reasonable period of time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Filing of Documents. In all matters before the full Commission, filings may not be made directly to individual commissioners except at the direction of the reviewer or the Executive Director.</text> </paragraph> <paragraph num="C."> <text>Motion Practice.</text> <paragraph num="(1)"> <text>A motion shall be made in writing, except when made at a hearing or prehearing conference in accordance with Regulation .11 of this chapter, and shall state concisely the action the movant desires the Commission to take, and supporting grounds and authority.</text> </paragraph> <paragraph num="(2)"> <text>A motion shall be filed within 20 days of the determination to which the motion responds.</text> </paragraph> <paragraph num="(3)"> <text>The following actions shall be taken by motion:</text> <paragraph num="(a)"> <text>A demand for an action which the movant desires the Commission, the reviewer, or the staff of the Commission to take;</text> </paragraph> <paragraph num="(b)"> <text>A request for reconsideration, under Regulation .19 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>An objection to the introduction of a statement or other evidence by a party during an evidentiary hearing held under Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>A challenge to a reviewer or other member of the Commission;</text> </paragraph> <paragraph num="(e)"> <text>An action that might be initiated properly or undertaken by a party to a review, and that is not otherwise provided for in this chapter; and</text> </paragraph> <paragraph num="(f)"> <text>Any other question that is justiciable.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A motion need not be verified unless it is based on facts not apparent from the record or documents filed in the proceeding.</text> </paragraph> <paragraph num="(5)"> <text>An applicant or interested party to the review may file one written answer to a motion, in the same format required of motions, within 10 days of the filing of the motion.</text> </paragraph> <paragraph num="(6)"> <text>Except as otherwise provided in these regulations, the reviewer or, in a matter in which no reviewer has been appointed, the Executive Director shall rule on a motion made prior to the issuance of a proposed decision or staff recommendation. Except as otherwise provided in these regulations, the Chair shall rule on all other motions.</text> </paragraph> <paragraph num="(7)"> <text>The person presiding over the motion may hear oral argument on the motion at the request of a party.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Decision.</text> <paragraph num="(1)"> <text>At any time after an application is docketed, staff may file a motion for summary decision to deny the application.</text> </paragraph> <paragraph num="(2)"> <text>The motion shall identify the grounds for the motion, which is not required to address every applicable State Health Plan standard. The applicant may respond to the motion in writing, within 15 days of receipt of the motion.</text> </paragraph> <paragraph num="(3)"> <text>The reviewer, or, in a matter in which no reviewer has been appointed, a commissioner appointed as motions officer by the Executive Director, may hear oral argument on the motion at the request of a party and shall issue a proposed ruling which shall be subject to review by the full Commission.</text> </paragraph> <paragraph num="(4)"> <text>A quorum of the full Commission shall make a final ruling on the motion for summary decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Ex Parte Contacts. After the docketing of an application and until the Commission renders its final decision under this regulation, the ex parte provisions of the State Government Article, Title 10, Annotated Code of Maryland, apply.</text> </paragraph> <paragraph num="F."> <text>Local Health Department Review and Comment. The Commission shall seek information and comment from each local health department in the health planning region for the proposed project, and shall consider any response from each health department in making a final decision on an application.</text> </paragraph> <paragraph num="G."> <text>Required Approvals.</text> <paragraph num="(1)"> <text>Except in emergency circumstances posing a threat to public health, all decisions of the Commission on an application for a Certificate of Need shall be consistent with applicable State Health Plan standards and criteria established by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>Unless the Commission finds that the facility or service for which a proposed expenditure is to be made is not needed or is not consistent with the State Health Plan, the Commission shall approve an application for a Certificate of Need to the extent that the expenditure will be made to eliminate or prevent an imminent safety hazard, as defined by federal, State, or local fire, building, or life safety codes or regulations, to comply with State licensing standards, or to comply with accreditation standards for reimbursement under Title XVIII of the Social Security Act or under the State Medical Assistance Program approved under Title XIX of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Notice of Final Action on a Certificate of Need Application. The Commission shall provide a copy of a CON decision to State or local licensing agencies, the Maryland Medical Assistance Program, and the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="I."> <text>Participation of Staff. A reviewer may seek the assistance of any member of the Commission staff in preparing a proposed decision.</text> </paragraph> <paragraph num="J."> <text>Transferability. A Certificate of Need or other Commission approval is not transferable.</text> </paragraph> <paragraph num="K."> <text>Consent Agenda.</text> <paragraph num="(1)"> <text>The Commission may take action on the following categories of items by use of a consent agenda at a public meeting of the Commission:</text> <paragraph num="(a)"> <text>Adoption of final regulations previously adopted by the Commission as proposed permanent regulations that:</text> <paragraph num="(i)"> <text>Do not result in public comments after publication in the Maryland Register; and</text> </paragraph> <paragraph num="(ii)"> <text>Contain no wording changes.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A change in an approved project that requires Commission approval pursuant to Regulation .17 of this chapter and is recommended for approval by the Executive Director with the exception of:</text> <paragraph num="(i)"> <text>An increase in the capital cost of a project that exceeds the approved capital cost inflated by the cost index specified in Regulation .17 of this chapter that also includes a change in the financing mechanism of the project; or</text> </paragraph> <paragraph num="(ii)"> <text>A change in the financing mechanism of the project.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Confirmation of an emergency CON issued by the Executive Director in accordance with Regulation .20 of this chapter.</text> </paragraph> <paragraph num="(d)"> <text>Other categories of actions that a majority of the fully authorized membership of the Commission votes to include on the consent docket.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Consent agenda items shall be disseminated to the Commissioners prior to the meeting along with copies of any related materials. At the beginning of the meeting, the Chair of the Commission will present the consent agenda to the Commissioners and ask whether anyone wishes to remove an item from the consent agenda to the main agenda or the next scheduled meeting. Items may be removed from the consent agenda on the request of any one Commissioner. Items not removed may be adopted by general consent without debate. Removed items may be taken up either immediately after the consent agenda, placed later on the agenda, or moved to the meeting that follows at the discretion of the Chair.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Evidentiary Hearings."> <paragraph num="A."> <text>Request for Evidentiary Hearing.</text> <paragraph num="(1)"> <text>Except as otherwise provided in these regulations, a request for an evidentiary hearing shall be made within 45 days of the docketing of an application or within 30 days after the modification of an application in a review.</text> </paragraph> <paragraph num="(2)"> <text>At the request of an applicant or interested party, the Commission may hold an evidentiary hearing in the review of a CON application for any health care facility other than an ambulatory surgical facility if, in the judgment of the reviewer, an evidentiary hearing is appropriate due to the magnitude of the impact that the proposed project may have on the health care delivery system and the project, if approved, would result in one of the following:</text> <paragraph num="(a)"> <text>A substantial negative impact on the costs and charges for the type of the facility, services, or both included in the project;</text> </paragraph> <paragraph num="(b)"> <text>A substantial negative impact on access to those facilities and services by the population in the proposed project’s expected service area;</text> </paragraph> <paragraph num="(c)"> <text>A significant decrease in the availability and overall quality of health care services in the affected area in a manner not consistent with policies or need projections set forth in the State Health Plan, such as by causing a loss of reasonable access to an essential medical service by a substantial number of patients; or</text> </paragraph> <paragraph num="(d)"> <text>Any impact that the reviewer concludes may be sufficiently serious to merit an evidentiary hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>General.</text> <paragraph num="(1)"> <text>Reviewer as Presiding Officer.</text> <paragraph num="(a)"> <text>If an evidentiary hearing is held in accordance with this chapter, the reviewer shall:</text> <paragraph num="(i)"> <text>Conduct a full, fair, and impartial hearing;</text> </paragraph> <paragraph num="(ii)"> <text>Take action to avoid unnecessary delay in the disposition of the proceedings; and</text> </paragraph> <paragraph num="(iii)"> <text>Maintain order.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A reviewer has the power to regulate the course of an evidentiary hearing and the conduct of the parties and authorized representatives, including the power to:</text> <paragraph num="(i)"> <text>Administer oaths and affirmations;</text> </paragraph> <paragraph num="(ii)"> <text>Rule upon offers of proof and receive relevant and material evidence;</text> </paragraph> <paragraph num="(iii)"> <text>Consider and rule upon motions in accordance with this chapter;</text> </paragraph> <paragraph num="(iv)"> <text>Examine witnesses and call witnesses as necessary to ensure a full and complete record;</text> </paragraph> <paragraph num="(v)"> <text>Limit unduly repetitious testimony and reasonably limit the time for presentations;</text> </paragraph> <paragraph num="(vi)"> <text>Grant a continuance or postponement;</text> </paragraph> <paragraph num="(vii)"> <text>Modify or waive, reasonably and for good cause, any time periods established by this chapter;</text> </paragraph> <paragraph num="(viii)"> <text>Request that parties submit legal memoranda, proposed findings of fact, and proposed conclusions of law;</text> </paragraph> <paragraph num="(ix)"> <text>Make proposed decisions and take any other appropriate action authorized by law;</text> </paragraph> <paragraph num="(x)"> <text>Issue orders as are necessary to secure procedural simplicity and administrative fairness and to eliminate unjustifiable expense and delay; and</text> </paragraph> <paragraph num="(xi)"> <text>Conduct the hearing in a manner suited to ascertain the facts and safeguard the rights of the parties to the hearing.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The reviewer may impose appropriate sanctions for failure to abide by this chapter or any lawful order of the reviewer.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Conduct of Evidentiary Hearings.</text> <paragraph num="(a)"> <text>An evidentiary hearing need not be conducted according to technical rules of evidence, but shall be conducted in accordance with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and these regulations.</text> </paragraph> <paragraph num="(b)"> <text>Reliable hearsay is admissible.</text> </paragraph> <paragraph num="(c)"> <text>Rules of privileges are effective to the extent they would be effective in a judicial proceeding in Maryland.</text> </paragraph> <paragraph num="(d)"> <text>Nonexpert opinion testimony may be considered.</text> </paragraph> <paragraph num="(e)"> <text>Qualification as an expert lies within the discretion of the reviewer. The qualification of an expert need not be based on academic degrees. Reasonably extensive practical experience with the subject may be sufficient for an expert qualification.</text> </paragraph> <paragraph num="(f)"> <text>Reliable and probative documents previously filed with or compiled by the Commission or its staff or consultants that are relevant to issues being considered by the Commission may be incorporated by reference into the record of a proceeding by the Commission or, by leave of the reviewer, by a party to the proceeding, upon notice to the parties and an opportunity to object.</text> </paragraph> <paragraph num="(g)"> <text>The reviewer may take administrative notice of all judicially cognizable facts to the same extent as courts of this State, either on the reviewer's own motion or at the request of a party. The reviewer may also take official notice, without meeting formal evidentiary rules, of general technical or scientific facts within the specialized knowledge of a member of the Commission. A party to the hearing is entitled, on timely request, to an opportunity to show that the Commission should not take administrative or official notice of specific facts and matters, or that the fact or matter to be officially noticed is inapplicable to the proceeding or is incorrect or misunderstood by the Commission.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A party to the hearing may be represented by counsel.</text> </paragraph> <paragraph num="(4)"> <text>The prehearing conference and the hearing shall be recorded. If an applicant or other person desires a transcript, that person shall pay all costs to transcribe the recording.</text> </paragraph> <paragraph num="(5)"> <text>Documents filed in the proceeding shall be served on the reviewer, the assistant attorneys general of the Commission, and each interested party, and shall include a certificate of service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prehearing Procedures.</text> <paragraph num="(1)"> <text>The reviewer shall hold a prehearing conference, and may hold settlement conferences, before an evidentiary hearing.</text> </paragraph> <paragraph num="(2)"> <text>The reviewer shall notify each applicant and interested party of the prehearing conference in writing. The notification shall:</text> <paragraph num="(a)"> <text>Include the date, time, and place of the prehearing conference or conferences;</text> </paragraph> <paragraph num="(b)"> <text>Summarize the rules of procedure governing the evidentiary hearing; and</text> </paragraph> <paragraph num="(c)"> <text>State the dates, if known, for the submission of prefiled testimony and the date, time, and place of the evidentiary hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The principal purpose of the prehearing conference is to expedite the evidentiary hearing. To this end the reviewer may, among other things:</text> <paragraph num="(a)"> <text>Instruct the parties to:</text> <paragraph num="(i)"> <text>Formulate and submit a list of genuine contested issues to be decided at the hearing;</text> </paragraph> <paragraph num="(ii)"> <text>Identify each potential witness, the subject matter of each witness's testimony, and documents to be introduced; and</text> </paragraph> <paragraph num="(iii)"> <text>Raise and address issues that can be decided before the hearing;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Encourage stipulations as to facts, law, and other matters;</text> </paragraph> <paragraph num="(c)"> <text>Schedule dates for the submission of prefiled testimony, further prehearings, the hearing, and submission of briefs and documents; and</text> </paragraph> <paragraph num="(d)"> <text>Rule on any pending motions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A written summary of the prehearing conference shall be made a part of the record of the proceeding.</text> </paragraph> <paragraph num="(5)"> <text>The reviewer may record the prehearing conference or have a stenographer present.</text> </paragraph> <paragraph num="(6)"> <text>A request for the postponement of a hearing shall be made at a reasonable time before the hearing and may be granted only for good cause shown, at the discretion of the reviewer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>List of Genuine Issues.</text> <paragraph num="(1)"> <text>The reviewer shall establish a list of genuine issues of material fact for the evidentiary hearing.</text> </paragraph> <paragraph num="(2)"> <text>An evidentiary hearing shall be held only on those genuine factual issues or issues on which the reviewer determines that testimony would be useful in rendering a decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Written Direct Testimony.</text> <paragraph num="(1)"> <text>Direct testimony shall be in writing and may not be delivered orally.</text> </paragraph> <paragraph num="(2)"> <text>A party who wishes to present testimony at the evidentiary hearing shall file written testimony before the hearing in accordance with the schedule set by the reviewer.</text> </paragraph> <paragraph num="(3)"> <text>The written direct testimony shall set forth the conclusions of the person submitting it and all arguments and facts supporting these conclusions.</text> </paragraph> <paragraph num="(4)"> <text>Written direct testimony shall be verified either under oath at the hearing or by including the statement specified in Regulation .08B(2) of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>Upon notice with an opportunity to object, the reviewer shall separate irrelevant material from the remainder of the record and keep that material apart. Parts of the body of the written direct testimony judged irrelevant by the reviewer shall be so marked and may not be considered by the Commission in its deliberations.</text> </paragraph> <paragraph num="(6)"> <text>Persons submitting written testimony shall make themselves available for oral cross-examination. Submitted application materials are also subject to cross-examination. Letters submitted into the record which are not considered written testimony are not subject to cross-examination.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Cross-Examination.</text> <paragraph num="(1)"> <text>Cross-examination of each witness shall be live and under oath.</text> </paragraph> <paragraph num="(2)"> <text>The reviewer and each non-proponent applicant and interested party may conduct reasonable cross-examination of a witness who gave direct or rebuttal testimony.</text> </paragraph> <paragraph num="(3)"> <text>The reviewer may set reasonable time limits on the cross-examination of witnesses.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Rebuttal Testimony.</text> <paragraph num="(1)"> <text>Rebuttal testimony is permitted on any issue specified by the reviewer.</text> </paragraph> <paragraph num="(2)"> <text>Rebuttal testimony, whether specified by the reviewer to be written or oral, is subject to live cross-examination.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Post-Hearing Briefs. The reviewer may request post-hearing briefs.</text> </paragraph> <paragraph num="I."> <text>Informal Proceedings. At the request of an applicant, and if each interested party waives the right to present evidence, argument, and conduct cross-examination, the reviewer may establish informal rules for mediation, structured negotiation, or another consensual procedure for reaching a decision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Holder Responsibilities and Penalties for Noncompliance."> <paragraph num="A."> <text>Project Implementation Schedule.</text> <paragraph num="(1)"> <text>An application for a CON or other Commission approval shall propose a schedule for implementation of the project that specifies the estimated time for, at a minimum, the following project implementation steps:</text> <paragraph num="(a)"> <text>The time required to enter a binding obligation following Commission approval of the application for the project;</text> </paragraph> <paragraph num="(b)"> <text>The time required to initiate construction, renovation, or both following execution of a binding obligation;</text> </paragraph> <paragraph num="(c)"> <text>The time required to complete the approved construction, renovation, or both following initiation of construction, renovation, or both; and</text> </paragraph> <paragraph num="(d)"> <text>The time required to place the new facility or modified facility in operation following the completion of approved construction, renovation, or both.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The proposed project implementation schedule for a project requiring a multiphased plan for implementation shall detail those multiple phases and specify the estimated time requirements for, at a minimum, the four time periods listed above for each phase.</text> </paragraph> <paragraph num="(3)"> <text>A holder shall abide by the project implementation schedule submitted with its application for a CON or other Commission Approval.</text> </paragraph> <paragraph num="(4)"> <text>The project implementation schedule may be reasonably modified by the holder during the period during which the project is being implemented with approval of Commission staff.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Progress Report.</text> <paragraph num="(1)"> <text>Up until an approved project’s completion, licensure, if required, and first use, a holder shall submit a semiannual progress report in the form and manner prescribed by Commission staff.</text> </paragraph> <paragraph num="(2)"> <text>The semiannual progress report shall detail the holder’s compliance with the project implementation schedule and any conditions on approval imposed by the Commission.</text> </paragraph> <paragraph num="(3)"> <text>A holder shall submit the semiannual progress reports in accordance with the following schedule:</text> <paragraph num="(a)"> <text>The first report shall be due at least 45 days before the 6-month anniversary of the final action awarding the CON or other Commission approval; and</text> </paragraph> <paragraph num="(b)"> <text>Subsequent progress reports shall be due every 6 months after the due date of the prior report.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Obligation.</text> <paragraph num="(1)"> <text>Except as provided by §C(2) of this regulation, a holder shall obligate at least 51 percent of the approved capital expenditure for a project involving building construction, renovation, or both, as documented by a binding construction contract or equipment purchase order, within the following specified time periods:</text> <paragraph num="(a)"> <text>An approved new hospital has up to 36 months to document the required obligation;</text> </paragraph> <paragraph num="(b)"> <text>A project involving an approved new non-hospital health care facility or involving a building addition or replacement of building space of a health care facility has up to 24 months to document the required obligation;</text> </paragraph> <paragraph num="(c)"> <text>A project limited to renovation of existing building space of a health care facility has up to 18 months to document the required obligation; and</text> </paragraph> <paragraph num="(d)"> <text>A project that does not involve construction or renovation shall document that the approved project is complete and operational within 18 months of project approval.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In a multiphased plan of construction with more than one construction contract approved for an existing health care facility, a holder has:</text> <paragraph num="(a)"> <text>Up to 12 months after approval to obligate 51 percent of the capital expenditure for the first phase of construction; and</text> </paragraph> <paragraph num="(b)"> <text>Up to 12 months after completion of the immediately preceding phase of construction to obligate 51 percent of the capital expenditure for any subsequent approved phase of construction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Effective Date of a CON or other Commission approval. The effective date of a CON or other approval is the date of Commission action approving the application for the project. If a request for reconsideration is timely filed under Regulation .19 of this chapter, the effective date of the approval is the date the Commission rules on the request. The filing of a notice of appeal does not stay enforcement of the Commission decision.</text> </paragraph> <paragraph num="E."> <text>Enforcement. The Commission may impose financial penalties, withdraw a CON or other Commission approval, or both, if it finds that:</text> <paragraph num="(1)"> <text>The person who obtained Commission approval made a material misrepresentation upon which the Commission relied in approving the application or issuing first use approval;</text> </paragraph> <paragraph num="(2)"> <text>The holder failed to demonstrate sufficient progress in implementing the project;</text> </paragraph> <paragraph num="(3)"> <text>The holder has failed to obligate or complete an approved project as required by §A of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>The person who obtained Commission approval failed to meet a condition on the approval;</text> </paragraph> <paragraph num="(5)"> <text>The holder failed to timely provide the semiannual progress report required under §B of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>The project differs materially from that approved by the Commission, including failure to timely seek approval of a project change in accordance with Regulation .17 of this chapter; or</text> </paragraph> <paragraph num="(7)"> <text>The holder failed to obtain approval under Regulation .18 of this chapter prior to first use of any portion of a facility or service developed under a CON or other Commission approval.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Financial Penalties.</text> <paragraph num="(1)"> <text>Financial penalties imposed in accordance with this regulation may not exceed:</text> <paragraph num="(a)"> <text>$100 per day for each day the violation continues for failure to timely provide a semiannual progress report; or</text> </paragraph> <paragraph num="(b)"> <text>1 percent of the approved budget for any other violation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Commission shall consider the following factors in determining the amount of any financial penalty:</text> <paragraph num="(a)"> <text>The willfulness of the improper conduct;</text> </paragraph> <paragraph num="(b)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(c)"> <text>The cost of investigation;</text> </paragraph> <paragraph num="(d)"> <text>The holder’s prior record of compliance;</text> </paragraph> <paragraph num="(e)"> <text>The budget approved in the CON or other Commission approval;</text> </paragraph> <paragraph num="(f)"> <text>The holder’s ability to pay; and</text> </paragraph> <paragraph num="(g)"> <text>If applicable, the amount of any unapproved capital cost increase that exceeds the approved budget.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Notice Before Enforcement Action.</text> <paragraph num="(1)"> <text>If Commission staff determines that a CON or other Commission approval should be withdrawn or financial penalties should be imposed, Commission staff shall inform the holder and each appropriate local health department, setting forth in writing the reasons for the proposed action.</text> </paragraph> <paragraph num="(2)"> <text>This notice shall set forth the right of the holder to submit written argument in support of its position and present oral argument to the Commission, as well as the right to an evidentiary hearing conducted in accordance with Regulation .11 of this chapter, to show cause why the approval should not be withdrawn or financial penalties should not be imposed.</text> </paragraph> <paragraph num="(3)"> <text>A holder that has failed to demonstrate sufficient progress in project implementation shall show good cause for the lack of progress.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Final action by the Commission imposing financial penalties or withdrawing a CON or other approval shall:</text> <paragraph num="(1)"> <text>Be in writing;</text> </paragraph> <paragraph num="(2)"> <text>Include findings of fact and conclusions of law; and</text> </paragraph> <paragraph num="(3)"> <text>Be transmitted to the holder and to each appropriate local health department within 30 days of the date of action by the Commission.</text> </paragraph> </paragraph> <paragraph num="I."> <text>CON Application after Withdrawal of a Prior CON. If a CON or other approval is withdrawn due to lack of sufficient progress in implementing the project, the holder may file an application seeking Commission approval to initiate or complete the previously authorized project, which shall be considered a new application by the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Procedures for Certificate of Conformance and Certificate of Ongoing Performance Applications."> <paragraph num="A."> <text>Coverage.</text> <paragraph num="(1)"> <text>A certificate of conformance is required to introduce primary or elective percutaneous coronary intervention services at a hospital.</text> </paragraph> <paragraph num="(2)"> <text>A certificate of ongoing performance is required and shall be periodically renewed to certify that a hospital providing cardiac surgery services or percutaneous coronary intervention services is maintaining an acceptable level of quality and performance in its provision of those services.</text> </paragraph> <paragraph num="(3)"> <text>A hospital with newly established cardiac surgery services or percutaneous coronary intervention services at an acute general hospital may continue to provide services without a certificate of ongoing performance until the Commission acts on the hospital’s first application for a certificate of ongoing performance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Submission of Applications.</text> <paragraph num="(1)"> <text>An application for a certificate of conformance or a certificate of ongoing performance shall be submitted to the Commission in a form and manner prescribed by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>An application shall be submitted in accordance with a published review schedule established by the Commission under §E of this regulation, except that applications to establish both primary and elective percutaneous coronary intervention services based on insufficient access under COMAR 10.24.17.04A(2)(b) may be filed at any time.</text> </paragraph> <paragraph num="(3)"> <text>The application, and all information supplementing the application, shall be signed by at least one principal of the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of this application are true to the best of my knowledge, information, and belief.”</text> </paragraph> </paragraph> <paragraph num="C."> <text>Completeness Review of Certificate of Conformance Applications.</text> <paragraph num="(1)"> <text>Commission staff shall review a certificate of conformance application for completeness within 15 business days.</text> </paragraph> <paragraph num="(2)"> <text>If staff determines the application is not complete, staff may request additional information to make the application complete within the 15-business-day period to review the application. The applicant shall provide full and clear responses to the completeness and additional information request within 15 business days unless an extension is requested and granted.</text> </paragraph> <paragraph num="(3)"> <text>If Commission staff determines after review of the application and information provided in response to staff’s request that the application is complete, staff shall notify the applicant of its determination.</text> </paragraph> <paragraph num="(4)"> <text>If an applicant fails to supply requested information within the specified time limit, staff may dismiss and return the application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Additional Information. Commission staff may:</text> <paragraph num="(1)"> <text>Request information from an applicant supplementing an application at any time during the review of an application, provided that such additional information is material to the determination of whether the applicant has satisfied the criteria and standards for approval; and</text> </paragraph> <paragraph num="(2)"> <text>Set reasonable time limits for the applicant to supply the requested information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice to the Public.</text> <paragraph num="(1)"> <text>At least once each year, the Commission staff shall publish in the Maryland Register a schedule for reviews of:</text> <paragraph num="(a)"> <text>Certificate of conformance applications to establish primary or elective percutaneous coronary intervention services; and</text> </paragraph> <paragraph num="(b)"> <text>Certificate of ongoing performance applications if at least one hospital is required to file an application in the time period covered by the schedule.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Commission shall publish, on its website, information on the receipt of applications for certificates of conformance and certificates of ongoing performance.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Commission shall act on an application for a certificate of conformance not later than 120 days after staff notified the applicant that the application is complete, except for applications reviewed in conjunction with a CON application in accordance with COMAR 10.24.17.04C.</text> </paragraph> <paragraph num="G."> <text>Criteria for Review of Applications. Applicable criteria and standards for certificate of conformance reviews and certificate of ongoing performance reviews are specified in COMAR 10.24.17, the State Health Plan chapter for cardiac surgery and percutaneous coronary intervention services.</text> </paragraph> <paragraph num="H."> <text>Staff Report and Recommendation. Commission staff shall review a certificate of conformance and certificate of ongoing performance applications and prepare a staff report and recommendation that contains the staff’s conclusion as to whether the applicant has met each applicable criterion and standard in COMAR 10.24.17.</text> </paragraph> <paragraph num="I."> <text>Exceptions.</text> <paragraph num="(1)"> <text>An applicant may submit exceptions to a staff report and recommendation and present oral argument on its exceptions to the Commission.</text> </paragraph> <paragraph num="(2)"> <text>Schedule.</text> <paragraph num="(a)"> <text>Staff’s issuance of a staff report and recommendation shall be accompanied by a notice that specifies the schedule for the submission of exceptions and the date of the Commission meeting at which the Commission shall hear oral argument on exceptions.</text> </paragraph> <paragraph num="(b)"> <text>Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff shall specify that:</text> <paragraph num="(i)"> <text>A party filing exceptions has at least 10 days to file exceptions; and</text> </paragraph> <paragraph num="(ii)"> <text>A party filing a response to exceptions has at least 7 days to file a response.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Exceptions shall specifically identify each staff conclusion to which exception is taken, citing those portions of the record on which each exception is based.</text> </paragraph> <paragraph num="(4)"> <text>Exceptions and any response to exceptions shall be limited to 25 pages, double-spaced, excluding attachments.</text> </paragraph> <paragraph num="(5)"> <text>Commission staff may file a written response to exceptions and present oral argument at the exceptions hearing.</text> </paragraph> <paragraph num="(6)"> <text>Oral arguments on exceptions to the staff report and recommendation and any response shall be limited to 10 minutes per argument unless extended by the Chair of the Commission.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Final Decision on an Application for Certificate of Conformance.</text> <paragraph num="(1)"> <text>A final decision on an application for a certificate of conformance shall contain findings of fact and conclusions of law and shall:</text> <paragraph num="(a)"> <text>Approve the application;</text> </paragraph> <paragraph num="(b)"> <text>Approve the application with conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A certificate of conformance issued by the Commission for an approved application shall specify the period of time for which the initial certificate is effective and the expected date by which the hospital is expected to seek a certificate of ongoing performance for its primary or elective percutaneous coronary intervention services or both.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Final Decision on an Application for Certificate of Ongoing Performance.</text> <paragraph num="(1)"> <text>The Commission's final decision on an application for a certificate of ongoing performance shall contain findings of fact and conclusions of law and shall:</text> <paragraph num="(a)"> <text>Approve the application;</text> </paragraph> <paragraph num="(b)"> <text>Approve the application with conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Deny the application or revoke the Commission’s approval for the involved services provided that all the steps in COMAR 10.24.17 including performance of a focused review and an opportunity for agreement upon and completion of a plan of correction have been provided to the hospital.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A certificate of ongoing performance issued by the Commission shall specify the period of time for which the certificate is effective and the expected date by which the hospital is expected to seek a new certificate of ongoing performance for its primary or elective percutaneous coronary intervention services or both, as applicable, or for its cardiac surgery services.</text> </paragraph> <paragraph num="(3)"> <text>The duration of a certificate of ongoing performance may be extended beyond the renewal deadline, if due to extenuating circumstances, the Executive Director determines an extension is necessary and appropriate, prior to staff producing a written report and recommendation to the Commission regarding the hospital’s application for renewal of its certificate of ongoing performance.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The decision of the Commission shall be by a majority of the quorum present and voting.</text> </paragraph> <paragraph num="M."> <text>The decision of the Commission is subject to judicial review in accordance with Regulation .09F of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Special Procedures."> <paragraph num="A."> <text>Determination of Coverage. Except as otherwise provided in Regulations .03 or .05 of this chapter, a project that requires a determination of coverage shall be dealt with in the following manner:</text> <paragraph num="(1)"> <text>A written request for determination of coverage shall be filed with the Center for Health Care Facilities Planning and Development.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director of the Commission shall review the request and act on it within 30 business days of receipt of complete information.</text> </paragraph> <paragraph num="(3)"> <text>The person requesting the determination shall provide all additional information requested by Commission staff.</text> </paragraph> <paragraph num="(4)"> <text>The Commission shall notify the person, each appropriate local health department, and each agency responsible under the Department's licensure program for the type of project whether it requires a Certificate of Need or other Commission review.</text> </paragraph> <paragraph num="(5)"> <text>Commission staff’s determination of coverage may be appealed by the requesting party to the Commission by use of a motion filed in accordance with Regulation .10C of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>The Executive Director may issue a determination that:</text> <paragraph num="(a)"> <text>Certificate of Need or other Commission review is not required; or</text> </paragraph> <paragraph num="(b)"> <text>Certificate of Need review is required for stated reasons.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Declaratory Rulings.</text> <paragraph num="(1)"> <text>A person uncertain as to how a statute or regulation enforced by the Commission applies to that person or that person’s property may file with the Commission a petition for a declaratory ruling in accordance with the procedures in §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Commission may decline to issue a declaratory ruling for any of the following reasons:</text> <paragraph num="(a)"> <text>The petition is not in accordance with this section;</text> </paragraph> <paragraph num="(b)"> <text>The petition contains insufficient factual or legal information upon which to base a declaratory ruling;</text> </paragraph> <paragraph num="(c)"> <text>The petition raises issues adequately addressed in a final decision or regulation of the Commission;</text> </paragraph> <paragraph num="(d)"> <text>The petition fails to pose a significant issue;</text> </paragraph> <paragraph num="(e)"> <text>The petition is properly heard as part of an evidentiary hearing; or</text> </paragraph> <paragraph num="(f)"> <text>A declaratory ruling would not be in the public interest.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 15 days of receipt of a petition, the Executive Director shall either assign the petition to the full Commission for a decision or appoint a Commissioner to make a proposed ruling on the petition, which ruling shall be considered by the full Commission.</text> </paragraph> <paragraph num="(4)"> <text>Within 45 days, or by the second regularly scheduled Commission meeting following the filing of the petition, whichever is later, the Commission shall rule or decline to rule on the petition, or may postpone issuing a formal written declaratory ruling for up to 35 days.</text> </paragraph> <paragraph num="(5)"> <text>To secure a declaratory ruling, an affected person shall submit a petition for a declaratory ruling that contains the following information:</text> <paragraph num="(a)"> <text>The petitioner's name, address, and telephone number;</text> </paragraph> <paragraph num="(b)"> <text>A one or two sentence statement of each question on which a ruling is requested;</text> </paragraph> <paragraph num="(c)"> <text>A one or two sentence summary of the petitioner's position on each question;</text> </paragraph> <paragraph num="(d)"> <text>Citation to each provision that the Commission needs to interpret in order to answer each question posed;</text> </paragraph> <paragraph num="(e)"> <text>A brief statement of each relevant fact;</text> </paragraph> <paragraph num="(f)"> <text>The petitioner's factual, legal, and policy arguments, referring to documents, affidavits, data, and other relevant information, which shall be appended to the petition, unless the documents are readily accessible to the Commission; and</text> </paragraph> <paragraph num="(g)"> <text>A statement by the petitioner under penalties of perjury that each fact recited as relevant to the question posed is true to the best of the petitioner's knowledge, information, and belief.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The Commission shall promptly publish notice of the receipt of a petition in the Maryland Register and shall note the petition on meeting agendas until the Commission acts upon the petition.</text> </paragraph> <paragraph num="(7)"> <text>The Commissioner making a proposed ruling or the Commission, in addition to considering the materials submitted by the petitioner and comments from staff, may:</text> <paragraph num="(a)"> <text>Request and receive oral or written statements from any person;</text> </paragraph> <paragraph num="(b)"> <text>Consider any document, data, study, or other relevant material; or</text> </paragraph> <paragraph num="(c)"> <text>Require argument on the question on the record, giving the petitioner the opportunity to present argument and to proffer witnesses and documents for the Commission's consideration.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The proposed and final declaratory ruling shall be in writing, and state:</text> <paragraph num="(a)"> <text>Each question addressed;</text> </paragraph> <paragraph num="(b)"> <text>The proposed or final ruling; and</text> </paragraph> <paragraph num="(c)"> <text>The factual and legal basis for the ruling.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A final declaratory ruling binds the Commission and the petitioner on the facts set forth in the petition, except when this binding effect violates the due process rights of a competing applicant in a comparative review.</text> </paragraph> <paragraph num="(10)"> <text>The Commission may revoke, alter, or amend a proposed or final declaratory ruling, which may have prospective effect only.</text> </paragraph> <paragraph num="(11)"> <text>A petitioner may appeal the declaratory ruling as set forth in State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Commission Approval Required Before Certain Actions."> <paragraph num="A."> <text>Obligation of Capital Expenditure.</text> <paragraph num="(1)"> <text>A person may not incur an obligation for a capital expenditure for a project that is subject to review under these regulations until the applicant receives a CON or other required Commission approval.</text> </paragraph> <paragraph num="(2)"> <text>An obligation for capital expenditure is incurred by or on behalf of a health care facility:</text> <paragraph num="(a)"> <text>When a contract, enforceable under State law, is entered into by or on behalf of the health care facility for the construction, acquisition, lease, or financing of a capital asset;</text> </paragraph> <paragraph num="(b)"> <text>When a governing body of the health care facility takes formal action to commit its own funds for a construction project undertaken by the health care facility as its own contractor; or</text> </paragraph> <paragraph num="(c)"> <text>In the case of donated property, on the date on which the gift is completed under applicable State law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Obligation of Predevelopment Expenditures. An applicant proposing predevelopment expenditures requiring review under this chapter may not enter into a binding contract or other obligation for such activities until the applicant receives a CON or other required Commission approval.</text> </paragraph> <paragraph num="C."> <text>Binding Commitments for Financing. A binding arrangement or commitment for financing a project may not be entered into by an applicant until the applicant receives a CON or other required Commission approval for the project.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Voluntary Withdrawal of an Application."> <text>An applicant may voluntarily withdraw its application without prejudice prior to final action by the Commission on the application. Written notice of the withdrawal shall be submitted to the Commission through the Executive Director. A withdrawn application may be resubmitted at a later date as a new application.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Project Changes After Commission Approval."> <paragraph num="A."> <text>Filing of Request. A holder that desires to change a project that has received CON or other Commission approval shall submit a request for the proposed change and supporting documentation to the Commission, copying each local health department within the health planning region of the project and, in the case of a change in the location or address of a project involving construction of a new health care facility, to all health care facilities of that type located in the health planning region.</text> </paragraph> <paragraph num="B."> <text>Commission Approval Required Before Project Changes. Any of the following proposed changes that would place the project at variance with its CON or other approval issued under this chapter, including any condition placed on the approval, shall be reviewed by the Commission:</text> <paragraph num="(1)"> <text>A significant change in physical plant design;</text> </paragraph> <paragraph num="(2)"> <text>A capital cost increase that exceeds the approved capital cost inflated by an amount determined by applying the Hospital Capital Market Baskets published by IHS Markit in Health Care Cost Review or other guidance approved by the Commission and posted on the Commission website from the application submission date to the date of the filing of a request for a project change;</text> </paragraph> <paragraph num="(3)"> <text>A change in the financing mechanisms of the project; or</text> </paragraph> <paragraph num="(4)"> <text>A change in the location of the project.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Impermissible Changes. The following proposed changes to an approved project require a new CON or other appropriate review and may not be considered by the Commission:</text> <paragraph num="(1)"> <text>Changes in the fundamental nature of a facility or the services to be provided in the facility from those that were approved by the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Increases in the facility’s total bed capacity or operating room inventory; or</text> </paragraph> <paragraph num="(3)"> <text>Changes in the medical service provided or approved.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Commission Action.</text> <paragraph num="(1)"> <text>Requested changes subject to review under §B of this regulation shall be reviewed by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>Within 5 days after the Commission’s receipt of a written request to change the address or location of an approved project, Commission staff shall arrange to publish notice of receipt of the change request in the Maryland Register and one newspaper of general circulation in the appropriate health planning region, shall post the notice on its website, and shall provide written notice of receipt of the change request to:</text> <paragraph num="(a)"> <text>Each member of the General Assembly in whose district the relocation is planned;</text> </paragraph> <paragraph num="(b)"> <text>Each member of the governing body for the jurisdiction in which the relocation is planned; and</text> </paragraph> <paragraph num="(c)"> <text>The county executive, mayor, or chief executive officer, if any, in whose county or city the relocation is planned.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide a written notification within 45 days of the Commission’s receipt of a complete change request that:</text> <paragraph num="(a)"> <text>The proposed change is approved in whole or part and incorporated into a modified CON or other modified approval for the project with conditions as appropriate; or</text> </paragraph> <paragraph num="(b)"> <text>The proposed change is denied, with explanation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Review Required Before Licensing or First Use of Project."> <paragraph num="A."> <text>Request for First Use Review and Approval. Not fewer than 60 days but not more than 120 days before the first use of any portion of a facility or service developed under a CON or other Commission approval, the holder shall specify the anticipated date for first use and request in writing, through the Center for Health Care Facilities Planning and Development, a final review and first use approval. The request shall include:</text> <paragraph num="(1)"> <text>Documentation of the final cost of the project; and</text> </paragraph> <paragraph num="(2)"> <text>A description of any differences in physical plant design, space, or services in the finished project when compared with the description of the project reviewed and approved by the Commission.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Action on Request. Within 30 days of receipt of all required information, Commission staff shall issue an approval for first use or a finding that the project does not conform to its CON or other Commission approval. Issuance of first use approval is not a new final decision concerning a CON and may not be appealed.</text> </paragraph> <paragraph num="C."> <text>Nonconformance with CON or Other Commission Approval. If the Executive Director finds that a project does not conform to its CON or other approval, the applicant may not proceed to licensure or first use until the Executive Director issues a written finding that the project conforms with its approval. Based on a finding that a project varies significantly from the project that was granted a CON or other approval, the Executive Director may invoke the full review process established in Regulation .04, Regulations .08—.10, and Regulation .13 of this chapter in order to reexamine the project.</text> </paragraph> <paragraph num="D."> <text>Duration of First Use Approval. First use approval remains in effect for 90 days. If a project is not put into use within that 90-day period, the holder shall reapply for first use approval.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Reconsideration Procedures."> <paragraph num="A."> <text>Request for Reconsideration. An aggrieved party may request that the Commission conduct a hearing to reconsider a Commission final decision to grant, to grant with conditions, or to deny a Certificate of Need application, a request for an exemption from CON review, or a certificate of conformance application issued under this chapter. This request shall be in writing and filed with the Center for Health Care Facilities Planning and Development within 15 days of the date upon which the Commission renders its decision and shall show good cause for reconsideration of the decision.</text> </paragraph> <paragraph num="B."> <text>Good Cause. For purposes of this regulation, a request for a reconsideration shows good cause if it:</text> <paragraph num="(1)"> <text>Presents significant, relevant information which was not previously presented to the Commission and which, with reasonable diligence, could not have been presented before the Commission made its decision;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates that there have been significant changes in factors or circumstances relied upon by the Commission in reaching its decision; or</text> </paragraph> <paragraph num="(3)"> <text>Demonstrates that the Commission has materially failed to follow its adopted procedures in reaching its decision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice of Reconsideration Request. At least 15 days prior to the date the Commission will consider a request for reconsideration, the Commission shall provide written notice of the date to the person making the request, each applicant, each interested party, and each relevant local health department. Each interested party may file a written response.</text> </paragraph> <paragraph num="D."> <text>A request to present oral arguments shall be made at the time of filing an initial request for reconsideration or a response.</text> </paragraph> <paragraph num="E."> <text>If the Commission determines that good cause has been demonstrated, the Commission may reverse or modify its previous decision. Within 30 days, the Commission shall issue a new decision containing written findings of fact and conclusions of law stating the basis for its decision, which shall be its final decision for the purpose of judicial review.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Emergency Certificate of Need."> <paragraph num="A."> <text>The Executive Director may issue an emergency Certificate of Need under the following circumstances that would otherwise require issuance of a CON:</text> <paragraph num="(1)"> <text>A situation presents hazards to employees or patients of a health care facility, and the project required to address the situation would otherwise require CON review;</text> </paragraph> <paragraph num="(2)"> <text>The closing of a health care facility by State licensing authorities requires changes or adjustments in other facilities to accommodate displaced patients, and the changes or adjustments would otherwise require that these facilities obtain a CON under these regulations; or</text> </paragraph> <paragraph num="(3)"> <text>A project that would require CON review is necessary to address a public health emergency and cannot be delayed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Procedure for an Emergency Certificate of Need.</text> <paragraph num="(1)"> <text>A health care facility may apply for an emergency CON by sending a signed letter in PDF format by email and hard copy to the Executive Director that contains:</text> <paragraph num="(a)"> <text>A description of the project for which an emergency CON is sought;</text> </paragraph> <paragraph num="(b)"> <text>An explanation of the need for emergency action;</text> </paragraph> <paragraph num="(c)"> <text>The location and current use of the space where the proposed project will be implemented;</text> </paragraph> <paragraph num="(d)"> <text>The time frame by which the project can be implemented;</text> </paragraph> <paragraph num="(e)"> <text>Approximate cost, if known; and</text> </paragraph> <paragraph num="(f)"> <text>Status of existing unused physical bed space at the health care facility that could quickly be converted to inpatient or resident care to address the emergency.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The applicant shall timely provide additional information requested by Commission staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Commission Action.</text> <paragraph num="(1)"> <text>The Executive Director may grant or deny an emergency CON application after consultation with the Chair of the Commission and receipt of suitably detailed information from the applicable State licensing agency regarding the need for emergency action. If, upon receipt of this information, the Executive Director agrees that the project is needed to address an emergency situation, the Executive Director shall issue an emergency Certificate of Need. The issuance of an emergency CON shall be on the agenda of the next scheduled Commission meeting for confirmation by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director may exercise the discretion not to make a decision on an emergency CON application and refer the application for consideration by the Commission. If a quorum of the Commission agrees that the project is needed to address an emergency situation, the Commission shall issue an emergency Certificate of Need.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Duration of Emergency Certificate of Need. The emergency CON is temporary and is valid for a period not to exceed 165 days. The duration of an emergency CON may be extended by the Executive Director for good cause shown by the applicant or at the request of the Secretary.</text> </paragraph> <paragraph num="E."> <text>A health care facility that desires to retain the capacity or project approved in an emergency CON shall, at least 30 days before the termination of the emergency CON, file a letter of intent followed by a CON application in accordance with the provisions in Regulation .08 of this chapter for an unscheduled review. The normal review process and time period set forth in this chapter apply to the review of a CON application filed after issuance of an emergency CON. This filing deadline may be extended by the Executive Director. The duration of an emergency CON shall be extended automatically during any period of time when the applicant has properly and timely sought a CON to retain the capacity or project approved on an emergency basis.</text> </paragraph> <paragraph num="F."> <text>Review of Denied Application. In the event the Executive Director denies an application for an emergency CON, the applicant may submit a written request for Commission review of the decision within 15 days of the denial, stating with particularity the grounds and factual basis for the applicant’s disagreement with the Executive Director’s decision. The Commission shall make a decision on the request for review within 45 days of the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Acquisitions of Nursing Homes."> <paragraph num="A."> <text>Notice of Transfers of Ownership.</text> <paragraph num="(1)"> <text>A person shall provide notice to the Commission at least 30 days before the change of ownership of a nursing home, including changes in ownership of real property and improvements, bed rights, or operatorship, that:</text> <paragraph num="(a)"> <text>Involves at least a 5 percent transfer in ownership interest; and</text> </paragraph> <paragraph num="(b)"> <text>Is not an acquisition that requires approval under §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice required by §A(1) of this regulation shall be in a form required by the Commission and include:</text> <paragraph num="(a)"> <text>A description of the change in ownership interest;</text> </paragraph> <paragraph num="(b)"> <text>Complete organizational charts for all persons holding at least a 5 percent ownership interest in the nursing home prior to and following the proposed transfer;</text> </paragraph> <paragraph num="(c)"> <text>An attestation that the change does not require approval under §B of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>Any other information requested by the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Request for Acquisition Approval.</text> <paragraph num="(1)"> <text>Applicability.</text> <paragraph num="(a)"> <text>This section does not apply to an acquisition that:</text> <paragraph num="(i)"> <text>Involves only changes of ownership interests among existing owners of a nursing home; or</text> </paragraph> <paragraph num="(ii)"> <text>The Commission has exempted from these requirements in accordance with COMAR 10.24.20.06A(3).</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>This section applies to:</text> <paragraph num="(i)"> <text>Transfers of stock or assets of the owner of the real property and improvements, bed rights, or operation of the nursing home, or any combination thereof;</text> </paragraph> <paragraph num="(ii)"> <text>An affiliation agreement between non-profit entities that changes the person who controls a nursing home’s operation or assets; and</text> </paragraph> <paragraph num="(iii)"> <text>A lease agreement that changes the person who controls a nursing home’s operation or assets.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 60 days before closing on an acquisition of a nursing home, a person shall:</text> <paragraph num="(a)"> <text>Submit to the Commission a request for acquisition approval in a form prescribed by the Commission; and</text> </paragraph> <paragraph num="(b)"> <text>Provide notice, in the form prescribed by the Commission, to the residents, resident representatives, and employees of the nursing home that:</text> <paragraph num="(i)"> <text>The request for acquisition approval was submitted to the Commission; and</text> </paragraph> <paragraph num="(ii)"> <text>They have the right to submit comments.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notice by the Commission to the Public, and Other State Agencies. Within 5 days after it receives a complete request for acquisition approval, the Commission shall:</text> <paragraph num="(a)"> <text>Submit notice of its receipt and the deadline for residents, resident representatives and employees of the nursing home to submit comments on the proposed acquisition:</text> <paragraph num="(i)"> <text>To at least one newspaper of general circulation in the affected area;</text> </paragraph> <paragraph num="(ii)"> <text>To be published in the next available issue of the Maryland Register; and</text> </paragraph> <paragraph num="(iii)"> <text>On the Commission’s website; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide notice of the request to:</text> <paragraph num="(i)"> <text>The Secretary or the Secretary’s designee;</text> </paragraph> <paragraph num="(ii)"> <text>The Office of the Attorney General;</text> </paragraph> <paragraph num="(iii)"> <text>The Secretary of Aging; and</text> </paragraph> <paragraph num="(iv)"> <text>The State Long-Term Care Ombudsman Program.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Executive Director Action.</text> <paragraph num="(1)"> <text>The Executive Director shall review a request for acquisition approval within 45 days after receiving the completed request from the applicant.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director, in consultation with the Secretary or the Secretary’s designee, may:</text> <paragraph num="(a)"> <text>Approve the acquisition;</text> </paragraph> <paragraph num="(b)"> <text>Approve the acquisition with conditions;</text> </paragraph> <paragraph num="(c)"> <text>Deny the acquisition; or</text> </paragraph> <paragraph num="(d)"> <text>Refer the request for acquisition approval to the Commission for a final decision.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To approve a request for acquisition approval, the Executive Director must find that the acquisition:</text> <paragraph num="(a)"> <text>Is consistent with COMAR 10.24.20, the State Health Plan chapter for Comprehensive Care Facility (Nursing Home) Services; and</text> </paragraph> <paragraph num="(b)"> <text>Is in the public interest.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In determining whether an acquisition of a nursing home is in the public interest, the Executive Director shall:</text> <paragraph num="(a)"> <text>Consider comments from individuals who:</text> <paragraph num="(i)"> <text>Reside in the nursing home;</text> </paragraph> <paragraph num="(ii)"> <text>Have family members who reside in the nursing home; or</text> </paragraph> <paragraph num="(iii)"> <text>Are employed as employees of the nursing home;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Consult with the Attorney General on whether the acquisition raises public interest concerns.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Commission Action. If the Executive Director refers a request for acquisition approval to the Commission under §C(2)(d) of this regulation , the Commission shall use the criteria specified in §C(3) and (4) of this regulation to make a final decision within 60 days after receiving the completed request from the applicant.</text> </paragraph> <paragraph num="E."> <text>The Commission shall promptly send a copy of the decision of the Executive Director or Commission on a request for acquisition approval to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman.</text> </paragraph> <paragraph num="F."> <text>Appeal.</text> <paragraph num="(1)"> <text>Commission Review of Executive Director Decision.</text> <paragraph num="(a)"> <text>A person who is a party to the acquisition may seek Commission review of an Executive Director’s decision denying the request or imposing a condition on approval.</text> </paragraph> <paragraph num="(b)"> <text>A request for review of an Executive Director’s decision:</text> <paragraph num="(i)"> <text>Shall be filed within 15 days after the issuance of a decision;</text> </paragraph> <paragraph num="(ii)"> <text>Shall specifically identify each finding and conclusion to which review is requested; and</text> </paragraph> <paragraph num="(iii)"> <text>May include a request for oral argument.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Commission shall review the Executive Director’s decision within 45 days of the request for review.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Judicial Review.</text> <paragraph num="(a)"> <text>A decision of the Commission under §D or §F(1) of this regulation shall be a final decision for the purpose of judicial review.</text> </paragraph> <paragraph num="(b)"> <text>A person that is a party to the acquisition may take a direct judicial appeal within 30 days after the Commission makes the final decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Annual Reports.</text> <paragraph num="(1)"> <text>On or before July 1 immediately following the acquisition of a nursing home and each year for 3 years thereafter, the person that acquired the nursing home shall submit a report to the Commission in accordance with COMAR 10.24.20.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall provide a copy of the report required under §G(1) of this regulation to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Severability."> <text>If any provision of this chapter is declared void by a court of law, the remainder of this chapter shall be unaffected and of continued force and effect.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Effective Date."> <paragraph num="A."> <text>A letter of intent or application submitted after the effective date of these regulations is subject to their provisions.</text> </paragraph> <paragraph num="B."> <text>A request for a determination of coverage under Regulation .14A of this chapter, submitted after the effective date of these regulations, is subject to the provisions of this chapter.</text> </paragraph> <paragraph num="C."> <text>Upon request by a holder, a project that has previously received a Certificate of Need or other Commission approval may be governed by this chapter.</text> </paragraph> <paragraph num="D."> <text>Pending Reviews.</text> <paragraph num="(1)"> <text>Except in contested or comparative CON reviews, an application for a CON or other Commission approval pending at the time these regulations become effective shall be subject to their provision upon request of the applicant.</text> </paragraph> <paragraph num="(2)"> <text>Upon request of an applicant for a CON in a contested or comparative review, an application pending at the time these regulations become effective may be subject to their provisions with the consent of all interested parties and upon a finding of good cause by the reviewer.</text> </paragraph> <paragraph num="(3)"> <text>If the applicable CON review criteria have materially changed as a result of these regulations, the application of these regulations to a pending CON application shall be deemed a modification and governed by Regulation .08E of this chapter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (8), 19-116(b), 19-118(d), 19-120, 19-120.1, and 19-126, et seq. Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 6, 1972</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 amended effective February 4, 1976 (3:3 Md. R. 151)</annotation> <annotation type="History" subtype="Administrative History">Regulations .17 and .18 adopted effective February 4, 1976 (3:3 Md. R. 151)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 24, 1978 (5:6 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B; .02A, B; .05E; .06B, D — G, K; .07A, B, E; .08A, C; .09A; .11A, D; .15A, B; and .17A, B, D amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B; .02A; .06B, F, L; .09D; .11D; .19 amended effective January 25, 1980 (7:2 Md. R. 115)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective February 4, 1981 (8:4 Md. R. 334); emergency status expired June 20, 1981 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06M adopted as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855)</annotation> <annotation type="History" subtype="Administrative History">Regulations .09E, .11E — G, and .16-1 adopted effective January 25, 1980 (7:2 Md. R. 115)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16F repealed effective January 25, 1980 (7:2 Md. R. 115)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective March 18, 1983 (10:6 Md. R. 536); emergency status extended at 10:17 Md. R. 1520, 10:22 Md. R. 1964, and 11:5 Md. R. 460 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 23, 1984 (11:8 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended and recodified as .01-1, and Preface codified as new Regulation .01 effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .03D, .07H, and .20B amended as an emergency provision and .03F and .21 adopted as an emergency provision effective August 1, 1985 (12:17 Md. R. 1694); emergency status extended at 12:26 Md. R. 2540; emergency status reapproved effective April 4, 1987 (13:9 Md. R. 1021); emergency status extended at 13:14 Md. R. 1629 and 13:20 Md. R. 2206 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .02A, and .03B amended as an emergency provision and .03F adopted as an emergency provision effective February 28, 1986 (13:6 Md. R. 669) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B, .06C, E, .07A — D, F, P, .11, and .23 amended as an emergency provision and .06F adopted as an emergency provision effective March 15, 1986 (13:8 Md. R. 890) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01-1, .03, .06, .07, and .11 amended as an emergency provision effective July 16, 1987 (14:16 Md. R. 1767); emergency status extended at 14:18 Md. R. 1962 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01-1, .03, .06, .07, .11 and .23 amended as an emergency provision effective September 23, 1987 (14:21 Md. R. 2217); adopted permanently effective February 8, 1988 (15:3 Md. R. 304)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01-1, .03, .06, .07, .09, .11, .15 — .18, and .20 amended as an emergency provision effective March 9, 1989 (16:7 Md. R. 802); emergency status extended at 16:20 Md. R. 2178 and 17:3 Md. R. 295 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective February 13, 1995 (22:3 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1B amended effective April 6, 1987 (14:7 Md. R. 831); October 30, 1989 (16:21 Md. R. 2262); March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A — C amended effective November 17, 1986 (13:23 Md. R. 2480); March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 17, 1986 (13:23 Md. R. 2480); March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G — I amended effective February 13, 1995 (22:3 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H adopted effective April 6, 1987 (14:7 Md. R. 831)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective June 13, 1988 (15:12 Md. R. 1447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L adopted effective October 30, 1989 (16:21 Md. R. 2262)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 17, 1986 (13:23 Md. R. 2480); April 6, 1987 (14:7 Md. R. 831); March 19, 1990 (17:5 Md. R. 638); June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective November 17, 1986 (13:23 Md. R. 2480); August 3, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective February 13, 1995 (22:3 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective March 19, 1990 (17:5 Md. R. 638); October 10, 1994 (21:20 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective November 17, 1986 (13:23 Md. R. 2480)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23B amended effective April 6, 1987 (14:7 Md. R. 831)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23E, F amended effective February 13, 1995 (22:3 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.24.01.06 cited in Doctors' Hospital v. Health Resources Planning Commission, 65 Md. App. 656 (1986)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.24.01.07 cited in Sinai Hospital v. Health Resources Planning Commission, 306 Md. 472 (1986)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.24.01.07 cited in Perini Services Inc. v. Health Resources Planning Commission, 67 Md. App. 189 (1986)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .23 repealed and new Regulations .01 — .22 adopted effective November 6, 1995 (22:22 Md. R. 1658)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 21, 2000 (27:16 Md. R. 1523); February 5, 2001 (28:2 Md. R. 100); November 24, 2003 (30:23 Md. R. 1652); April 11, 2005 (32:7 Md. R. 680); October 23, 2006 (33:21 Md. R. 1675); April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 23, 2009 (36:4 Md. R. 345); amended permanently effective April 20, 2009 (36:8 Md. R. 595)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective August 21, 2000 (27:16 Md. R. 1523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective February 5, 2001 (28:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective August 21, 2000 (27:16 Md. R. 1523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 21, 2000 (27:16 Md. R. 1523); April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 24, 2003 (30:23 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, J amended effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I amended effective April 10, 2006 (33:7 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective August 21, 2000 (27:16 Md. R. 1523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective April 6, 1998 (25:7 Md. R. 527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C, E amended effective April 10, 2006 (33:7 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D, F amended effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E, G amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 11, 2005 (32:7 Md. R. 680); April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective April 10, 2006 (33:7 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective November 24, 2003 (30:23 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective April 10, 2006 (33:7 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective November 24, 2003 (30:23 Md. R. 1652); April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective May 5, 1997 (24:9 Md. R. 657)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E amended effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective April 11, 2005 (32:7 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.22 under Certificate of Need for Health Care Facilities repealed and new Regulations .01—.22 under Procedural Regulations for Health Care Facilities and Services adopted effective December 1, 2023 (50:22 Md. R. 975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 17, 2025 (52:3 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 mended effective February 17, 2025 (52:3 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective July 22, 2024 (51:14 Md. R. 678)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12E amended effective February 17, 2025 (52:3 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 adopted effective February 17, 2025 (52:3 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 recodified to be Regulation .22 effective February 17, 2025 (52:3 Md. R. 159)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 recodified to be Regulation .23 effective February 17, 2025 (52:3 Md. R. 159)</annotation> </annotations> </chapter> <chapter num="02" heading="Data Reporting by Hospitals"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“Hospital” means a facility defined as a hospital in Health-General Article, §19-301(e) and (g), Annotated Code of Maryland, and COMAR 10.07.01 including:</text> <paragraph num="(a)"> <text>All classifications of institutions set forth in Health-General Article, §19-307, Annotated Code of Maryland, and COMAR 10.07.01, including “general”, “special”, or other types of hospitals specified by rule or regulations pursuant to Health-General Article, §19-307, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>“Special rehabilitation” hospital, as set forth in Health-General Article, §19-318, Annotated Code of Maryland, and COMAR 10.07.01; and</text> </paragraph> <paragraph num="(c)"> <text>“Limited service” hospital, as set forth in Health-General Article, §19-307.1, Annotated Code of Maryland, and COMAR 10.07.17.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“HSCRC” means the Health Services Cost Review Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Collection and Reporting of Hospital Data."> <paragraph num="A."> <text>Hospitals shall submit accurate, timely, and complete data which the Commission deems necessary for development of methodologies, planning, analysis, and Certificate of Need reviews as requested on a periodic basis.</text> </paragraph> <paragraph num="B."> <text>The information requested by and to be reported to the Commission may include, but is not limited to, the following types of information:</text> <paragraph num="(1)"> <text>Aggregate facility data:</text> <paragraph num="(a)"> <text>Types of services offered;</text> </paragraph> <paragraph num="(b)"> <text>Licensed and operating hospital beds;</text> </paragraph> <paragraph num="(c)"> <text>Utilization data; and</text> </paragraph> <paragraph num="(d)"> <text>Staffing;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patient-specific data:</text> <paragraph num="(a)"> <text>Admission, discharge, and disposition data;</text> </paragraph> <paragraph num="(b)"> <text>Demographic characteristics;</text> </paragraph> <paragraph num="(c)"> <text>Patient residence data;</text> </paragraph> <paragraph num="(d)"> <text>Medical diagnosis and treatment data;</text> </paragraph> <paragraph num="(e)"> <text>Surgical and diagnostic procedure data;</text> </paragraph> <paragraph num="(f)"> <text>Attending and operating physicians; and</text> </paragraph> <paragraph num="(g)"> <text>Revenue data, including actual or expected source of payment; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Data that are needed by the Commission to perform the duties described in Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland, and that are not set forth in COMAR 10.37.04, 10.37.06 or 10.37.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §B(3) of this regulation, the Commission shall deem a hospital which reports data to the HSCRC to be in compliance with these regulations if it submits the information required by COMAR 10.37.04, 10.37.06 or 10.37.07 in full and within the time period set forth in those chapters.</text> </paragraph> <paragraph num="D."> <text>The Commission shall deem a State psychiatric hospital to be in compliance with these regulations if it submits the information required by COMAR 10.37.06 for private psychiatric hospitals under the jurisdiction of HSCRC.</text> </paragraph> <paragraph num="E."> <text>A hospital which does not come within the jurisdiction of HSCRC, is not required to report full patient specific data to HSCRC, as set forth in COMAR 10.37.04, 10.37.06, or 10.37.07, or is required to report data as provided in §B(3) of this regulation, shall submit to the Commission a complete response to its data request within 60 days of the last day of the time period covered by the request, or within 60 days of receipt by the hospital of a data request from the Commission, whichever is longer.</text> </paragraph> <paragraph num="F."> <text>The Commission shall specify the form and format of any hospital data submission requested under §§D and E of this regulation.</text> </paragraph> <paragraph num="G."> <text>Exemptions.</text> <paragraph num="(1)"> <text>A hospital reporting under §§D and E of this regulation may request an exemption from the Commission's data request.</text> </paragraph> <paragraph num="(2)"> <text>A request for an exemption shall be submitted in writing to the Executive Director of the Commission not later than 30 days before a submission is due, identifying the specific data element or elements for which an exemption is requested and explaining the reasons for the exemption request.</text> </paragraph> <paragraph num="(3)"> <text>The Executive Director shall send a response to the request for an exemption to the hospital within 10 days of receipt by the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Extensions."> <paragraph num="A."> <text>A hospital may request an extension of its submission date by letter to the Executive Director of the Commission submitted not later than 15 days before a submission is due, explaining the reason for the extension and a requested due date.</text> </paragraph> <paragraph num="B."> <text>The Executive Director shall send a response to the request for an extension to the hospital within 10 days of receipt by the Commission.</text> </paragraph> <paragraph num="C."> <text>Except as provided in Regulation .02B(3) of this chapter, for hospitals meeting the requirements of Regulation .02C of this chapter, extensions obtained in accordance with procedures established by HSCRC shall be deemed in compliance with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sanctions."> <text>Any hospital which fails to submit the information set forth in this chapter within the required time frame, in the absence of an extension granted by the Commission or HSCRC, may be subject to penalties as described in COMAR 10.25.12.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Summary Studies, Reports, and Compilations."> <text>Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information, except that disclosure may not be made in such a way that the data furnished for a specific patient can be identified.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-101 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 14, 1980 (7:23 Md. R. 2167)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 1, 1983 (9:9 Md. R. 904)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06, Submission of Certain Data to the Agency, repealed effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05, Data Reporting by Hospitals, adopted effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 28, 2005 (32:4 Md. R. 410)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 28, 2005 (32:4 Md. R. 410)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective February 28, 2005 (32:4 Md. R. 410)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 28, 2005 (32:4 Md. R. 410)</annotation> </annotations> </chapter> <chapter num="03" heading="Maryland Long-Term Care Survey"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Long-term care providers” means providers of institutional and community-based, long-term care services, including those providers identified in COMAR 10.24.08.</text> </paragraph> <paragraph num="(2)"> <text>“Maryland Long-Term Care Survey” means any written request for data from the Maryland Health Care Commission to long-term care providers. This data may include:</text> <paragraph num="(a)"> <text>Types of services offered;</text> </paragraph> <paragraph num="(b)"> <text>Operating policies and limits on operations;</text> </paragraph> <paragraph num="(c)"> <text>Revenue data;</text> </paragraph> <paragraph num="(d)"> <text>Cost data;</text> </paragraph> <paragraph num="(e)"> <text>Changes in licensed capacity;</text> </paragraph> <paragraph num="(f)"> <text>Utilization data;</text> </paragraph> <paragraph num="(g)"> <text>Patient/client-specific data including:</text> <paragraph num="(i)"> <text>Demographic data;</text> </paragraph> <paragraph num="(ii)"> <text>Admission and discharge data;</text> </paragraph> <paragraph num="(iii)"> <text>Reimbursement data; and</text> </paragraph> <paragraph num="(iv)"> <text>Diagnostic and functional data.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Collection and Submission of Data."> <paragraph num="A."> <text>Long-term care providers, on a periodic basis as requested, shall submit accurate, timely, and complete data required by the Commission for:</text> <paragraph num="(1)"> <text>The development of methodologies and planning; and</text> </paragraph> <paragraph num="(2)"> <text>Maintenance of the nursing home performance evaluation guide.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission shall:</text> <paragraph num="(1)"> <text>Annually survey providers of comprehensive care, extended care, chronic hospital care, and assisted living; and</text> </paragraph> <paragraph num="(2)"> <text>Prepare a schedule for surveying other long-term care providers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Providers shall retain a listing of all patient/client codes, as applicable, and a copy of the survey for 5 years to permit the Commission to follow up on unclear responses.</text> </paragraph> <paragraph num="D."> <text>Long-term care providers shall prepare and submit to the Commission within 60 days of receipt of the survey instrument, data responses to the Maryland Long-Term Care Survey. Failure to submit these responses in a timely fashion may subject the provider to penalties as described in COMAR 10.25.12.</text> </paragraph> <paragraph num="E."> <text>A survey required under this regulation does not replace any existing data requirements of the Department or any agencies or commissions of the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Extensions."> <paragraph num="A."> <text>A long-term care provider may request an extension of its submission date, by letter, to the Executive Director of the Commission, if the request:</text> <paragraph num="(1)"> <text>Is submitted not later than 15 days before the submission is due;</text> </paragraph> <paragraph num="(2)"> <text>Explains the reason for the extension; and</text> </paragraph> <paragraph num="(3)"> <text>Provides a requested due date.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Executive Director shall send a response to the request for an extension to a long-term care provider within 10 days of receipt of the request by the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Summary Studies, Reports, and Compilations."> <text>Summary studies, reports, or other compilations developed by the Commission or the Commission's staff, from the data submitted in accordance with this chapter, is public information, except that disclosure may not be made in such a way that the data furnished for a specific patient/client can be identified.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (7) and 19-116(b)(1) and (2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter 03 “Statewide Nursing Home Survey for 1981” effective May 10, 1982 (9:9 Md. R. 905); repealed effective March 11, 1985 (12:5 Md. R. 483)</annotation> <annotation type="History" subtype="Administrative History">Chapter 03 "1984 Maryland Long Term Care Survey" adopted effective March 11, 1985 (12:5 Md. R. 483)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 9, 1987 (14:3 Md. R. 273)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01B and .02B, C amended and Regulations .03 and .04 adopted as an emergency provision effective March 1, 1993 (20:6 Md. R. 578); emergency status expired June 28, 1993</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 5, 1993 (20:13 Md. R. 1049); August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective July 5, 1993 (20:13 Md. R. 1049)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .04 adopted effective July 5, 1993 (20:13 Md. R. 1049)</annotation> </annotations> </chapter> <chapter num="04" heading="Freestanding Ambulatory Surgical Facilities Survey"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>“Freestanding ambulatory surgical facilities” means facilities or offices which operate primarily for the purpose of providing surgical services to patients not requiring overnight hospitalization, and which are required to obtain a license under Health-General Article, §19-3B-02(a), Annotated Code of Maryland, including:</text> <paragraph num="(1)"> <text>A center, service, office, facility, or office of one or more health care practitioners or a group practice, as defined in Health Occupations Article, §1-301, Annotated Code of Maryland, that provides ambulatory surgical services in two or more operating rooms, or in one operating room where the providers receive a technical or facility fee;</text> </paragraph> <paragraph num="(2)"> <text>An existing ambulatory surgical facility or office of one or more health care practitioners that has received a Certificate of Need or a determination of exemption from Certificate of Need coverage from the Maryland Health Resources Planning Commission;</text> </paragraph> <paragraph num="(3)"> <text>Medicare-certified ambulatory surgical facilities;</text> </paragraph> <paragraph num="(4)"> <text>Hospital-affiliated ambulatory surgical facilities that are not subject to the Health Services Cost Review Commission's ambulatory surgery survey set forth in COMAR 10.37.07; and</text> </paragraph> <paragraph num="(5)"> <text>Ambulatory surgical facilities owned by or affiliated with health maintenance organizations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>“Freestanding ambulatory surgical facilities survey” means any written request for data from the Maryland Health Resources Planning Commission to freestanding ambulatory surgical facilities. This data may include:</text> <paragraph num="(1)"> <text>The name and address of the entity providing ambulatory surgical services, and the location where these services will be provided;</text> </paragraph> <paragraph num="(2)"> <text>The number of operating rooms at the location;</text> </paragraph> <paragraph num="(3)"> <text>The names of persons or organizations which have an ownership interest in the entity, and their officers, directors, partners, and owners;</text> </paragraph> <paragraph num="(4)"> <text>The names of any other ambulatory surgical facilities in which individuals listed in response to §B(3) of this regulation have an interest or other economic relationship, as an officer, director, partner, member, or owner;</text> </paragraph> <paragraph num="(5)"> <text>A listing of any other ambulatory surgical facilities at the same address;</text> </paragraph> <paragraph num="(6)"> <text>Contractual relationships to provide ambulatory surgical services between the entity and other health care facilities or health care providers who are not employees of the entity, or exercise only medical practice privileges at the location;</text> </paragraph> <paragraph num="(7)"> <text>The names and specialties of the health care practitioners who provide surgical services at the location and the types of procedures performed there;</text> </paragraph> <paragraph num="(8)"> <text>Cost, charge, and reimbursement data, including the amount of care reimbursed by Medicaid, Medicare, and other third-party payors, and the amount of uncompensated care provided by the entity;</text> </paragraph> <paragraph num="(9)"> <text>Utilization data, including types of procedures;</text> </paragraph> <paragraph num="(10)"> <text>Operating policies, including hours of operation;</text> </paragraph> <paragraph num="(11)"> <text>Patient-specific or patient aggregate data, including demographic data, data on reimbursement source and levels, on types of procedures, and on patient disposition; and</text> </paragraph> <paragraph num="(12)"> <text>Staffing requirements and patterns.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Collection and Submission of Data."> <paragraph num="A."> <text>All freestanding ambulatory surgical facilities shall submit accurate, timely, and complete data required by the Commission for the development of methodologies and planning on a periodic basis as requested.</text> </paragraph> <paragraph num="B."> <text>If patient-specific data is requested, providers shall assign to each patient an identification number in a format specified by the Commission. Providers shall retain a listing of all patient identifier codes for 5 years to permit the Commission to follow up on unclear responses.</text> </paragraph> <paragraph num="C."> <text>All freestanding ambulatory surgical facilities shall prepare and submit to the Commission within the time frames specified in the survey instrument, and in a machine-readable format specified by the Commission, data responses to the freestanding ambulatory surgical facilities survey. Failure to submit these responses in a timely fashion may subject the facility to penalties as described in COMAR 10.25.12. If the respondent cannot provide the data within the specified time frames, a written request for extension shall be submitted to the Commission.</text> </paragraph> <paragraph num="D."> <text>The data requested from freestanding ambulatory surgical facilities in a survey required under this regulation shall be coordinated with the reporting requirements of the Health Care Access and Cost Commission to ensure that the survey is compatible with and does not duplicate information collected by the Health Care Access and Cost Commission. A survey required under this regulation does not replace any existing data requirements of the Maryland Department of Health or any agencies or commissions of the State.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and 19-116(b)(1) and (2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 14, 1980 (7:23 Md. R. 2167)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02, Statewide Hospital Data Survey for 1980, repealed effective April 6, 1987 (14:7 Md. R. 831)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02, Freestanding Ambulatory Surgical Facilities Survey, adopted effective April 6, 1987 (14:7 Md. R. 831)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 15, 1996 (23:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuation of Authority to Provide Non-Primary PCI Through Participation in the Follow-On C-PORT E Registry"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“C-PORT study” means the randomized clinical research trial that was conducted by the Atlantic Cardiovascular Patient Outcomes Team (C-PORT) to determine whether nonprimary PCI performed in hospitals without on-site cardiac surgery services is as safe and effective as nonprimary PCI performed in hospitals with on-site cardiac surgery services.</text> </paragraph> <paragraph num="(3)"> <text>“Nonprimary percutaneous coronary intervention” means PCI capable of relieving coronary vessel narrowing associated with coronary artery disease unrelated to ST-segment elevation myocardial infarction and includes elective PCI.</text> </paragraph> <paragraph num="(4)"> <text>“Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing.</text> </paragraph> <paragraph num="(5)"> <text>“Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with ST-segment elevation myocardial infarction (STEMI) and is also known as emergency PCI.</text> </paragraph> <paragraph num="(6)"> <text>“Regional service area” means the area used for planning for cardiac surgery and PCI services, as provided in the State Health Plan, COMAR 10.24.17.</text> </paragraph> <paragraph num="(7)"> <text>“Registry” means the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI and that is:</text> <paragraph num="(a)"> <text>Maintained by the Principal Investigator in the C-PORT E Study of Non-Primary PCI;</text> </paragraph> <paragraph num="(b)"> <text>Overseen by the Johns Hopkins Institutional Review Board;</text> </paragraph> <paragraph num="(c)"> <text>Overseen by a Data and Safety Monitoring Board.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction.</text> </paragraph> <paragraph num="(9)"> <text>“Waiver to perform nonprimary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permitted an acute care hospital without on-site cardiac surgery services to perform nonprimary PCI services within the C-PORT study.</text> </paragraph> <paragraph num="(10)"> <text>“Waiver to perform primary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permits an acute care hospital without on-site cardiac surgery services to perform primary PCI services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose and Scope."> <paragraph num="A."> <text>In 2007, the Commission established a one-time process by which certain licensed acute general hospitals without on-site cardiac surgery services were awarded time-limited research waivers from the requirements of COMAR 10.24.17.04E, Policy 5.0, and were permitted to provide non-primary PCI services as part of the C-PORT E study to assess the safety and efficacy of providing non-primary PCI services for certain patient groups without on-site cardiac surgery, as provided in COMAR 10.24.17.04E, Policy 5.3.</text> </paragraph> <paragraph num="B."> <text>In 2007, the Commission determined that the C-PORT E study offered a means of acquiring information to support future evidence-based State health care policy and planning with regard to cardiovascular services.</text> </paragraph> <paragraph num="C."> <text>In 2011, after the C-PORT E research study concluded active enrollment, the Commission continued the research waiver of each hospital that was in good standing, thereby permitting each such hospital to continue to offer nonprimary PCI services while the required follow-up data on C-PORT E patients was collected and analyzed, provided that the hospital continued to perform non-primary PCI under the limitations and for the Registry term provided in prior regulations until such time as the Commission has the information from the research study that is needed to guide State policy about the regulation of non-primary PCI.</text> </paragraph> <paragraph num="D."> <text>Health-General Article, §19-120.1(d), Annotated Code of Maryland, effective July 1, 2012, provides that a certificate of conformance to establish a nonprimary PCI service is not required for a Registry hospital that the Commission determines, on or before December 31, 2012, continues to be in compliance with:</text> <paragraph num="(1)"> <text>Commission regulations, including COMAR 10.24.17, Table A-1; and</text> </paragraph> <paragraph num="(2)"> <text>The requirements of the Registry.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Commission has convened a clinical advisory group, in accordance with Health-General Article, §19-120.1(g)(3), Annotated Code of Maryland, that will offer advice to the Commission on the update of COMAR 10.24.17, the Cardiac Surgery and PCI Services Chapter of the State Health Plan. The analysis conducted as part of this update will review the C-PORT E study results, which were published in a peer-reviewed journal in March 2012 and will consider the system impact, including access, cost-effectiveness, and quality implications, of non-primary PCI being performed in hospitals without on-site cardiac surgery.</text> </paragraph> <paragraph num="F."> <text>Until the updated COMAR 10.24.17 is effective, each Registry hospital shall continue to meet each requirement in these regulations, including each requirement in the Registry’s manual of operations, in order to continue to provide nonprimary PCI.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions for Maintaining Authority to Perform Nonprimary PCI and Participation in Registry."> <paragraph num="A."> <text>A Registry hospital shall maintain compliance with the following requirements:</text> <paragraph num="(1)"> <text>A Registry hospital shall meet the criteria established in the manual of operations of the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI; and</text> </paragraph> <paragraph num="(2)"> <text>A Registry hospital shall continue to satisfy the following requirements:</text> <paragraph num="(a)"> <text>For institutional resources:</text> <paragraph num="(i)"> <text>Maintain a patient prioritization plan that guarantees that a patient who requires primary PCI for STEMI is given immediate preference for care in the cardiac catheterization laboratory;</text> </paragraph> <paragraph num="(ii)"> <text>Maintain a formal and properly executed written agreement with a tertiary care center that provides for the unconditional transfer of each non-primary PCI patient who requires additional care, including emergent or non-primary cardiac surgery or PCI, from the applicant hospital to the tertiary institution; and</text> </paragraph> <paragraph num="(iii)"> <text>Maintain its agreement with an advanced cardiac support emergency medical services provider that guarantees arrival of the air or ground ambulance at the applicant hospital within 30 minutes of a request for non-primary PCI patient transport by the applicant;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For physician resources, A Registry hospital shall maintain adequate staff necessary for the provision of primary and non-primary PCI services, including a minimum of three interventional cardiologists who:</text> <paragraph num="(i)"> <text>Meet the requirements in the C-PORT E study research protocol and in COMAR 10.24.17, Table A-1;</text> </paragraph> <paragraph num="(ii)"> <text>Can be available on-site within 30 minutes when on call; and</text> </paragraph> <paragraph num="(iii)"> <text>Agree to abide by the Device Selection Criteria in the applicable Manual of Operations;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For minimum volumes, A Registry hospital shall maintain a minimum volume of 200 PCI procedures during each year of its waiver;</text> </paragraph> <paragraph num="(d)"> <text>For follow-up of patients enrolled in the C-PORT E study, A Registry hospital shall maintain a patient follow-up rate of 98 percent; and</text> </paragraph> <paragraph num="(e)"> <text>For follow-up of patients enrolled in the Registry, A Registry hospital shall commit to patient follow-up through hospital discharge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A Registry hospital shall notify the Commission in writing within 3 business days of the occurrence of any of the following:</text> <paragraph num="(1)"> <text>The hospital performs non-primary PCI on a patient not enrolled in the Registry;</text> </paragraph> <paragraph num="(2)"> <text>The hospital's primary PCI waiver expires, is relinquished, or is withdrawn;</text> </paragraph> <paragraph num="(3)"> <text>The hospital fails to notify the Commission of the death of or a coronary artery bypass surgery experienced by a patient participating in the Registry;</text> </paragraph> <paragraph num="(4)"> <text>The hospital fails to perform a minimum of 200 PCI procedures annually each year after it received a non-primary PCI research waiver from the Commission; or</text> </paragraph> <paragraph num="(5)"> <text>The hospital fails to meet and maintain the criteria required by the Commission for participation in the Registry, or its participation in the Registry ends for any reason.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A hospital required to give notice under §B of this regulation shall, on written notice from the Commission, immediately relinquish its authority to perform nonprimary PCI.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Term."> <text>A hospital’s ability to provide non-primary PCI [by virtue of the extension of its research waiver and entry into] in the Registry expires on the earlier of:</text> <paragraph num="A."> <text>The date upon which the Commission determines, through implementation in an update to COMAR 10.24.17 or other appropriate regulation, that the results of the C-PORT E study are sufficiently complete to guide public policy;</text> </paragraph> <paragraph num="B."> <text>A finding by the Commission that the C-PORT E study did not produce reliable results to guide public policy; or</text> </paragraph> <paragraph num="C."> <text>A finding by the Commission that the evidence is insufficient to change Policy 5.0 of COMAR 10.24.17.04E that requires non-primary PCI to be performed in hospitals with on-site cardiac surgery services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Performance and Monitoring."> <paragraph num="A."> <text>Each Registry hospital shall provide data to the Commission in a form and manner acceptable to the Commission.</text> </paragraph> <paragraph num="B."> <text>Each Registry hospital shall submit periodic progress reports in a format specified by the Commission and, at the conclusion of the research project and, if requested, at the end of the Registry, submit final reports in a form and manner acceptable to the Commission, as provided in COMAR 10.24.17.05D(2)(d).</text> </paragraph> <paragraph num="C."> <text>Each Registry hospital shall authorize the C-PORT E study principal investigator and the Registry coordinator to provide data requested by the Commission.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-101, 19-118, 19-120, and 19-120.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective April 11, 2009 (36:10 Md. R. 714); amended permanently effective July 16, 2009 (36:14 Md. R. 984)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective March 23, 2011 (38:8 Md. R. 504); revised permanently effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 17, 2011 (38:21 Md. R. 1278)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 4, 2013 (40:4 Md. R. 346)</annotation> </annotations> </chapter> <chapter num="06" heading="Data Reporting by Non-Hospital Health Care Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“Non-hospital health care facility” means:</text> <paragraph num="(a)"> <text>A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>An ambulatory surgical facility, as defined in Health-General Article, §19-114, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A facility providing intermediate care, as that term is defined in COMAR 10.24.01.01;</text> </paragraph> <paragraph num="(d)"> <text>A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(g)"> <text>A comprehensive care facility, as defined in COMAR 10.24.01.01; and</text> </paragraph> <paragraph num="(h)"> <text>Other non-hospital health institutions, services, or programs that may be specified as requiring a certificate of need under State law.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Collection and Reporting of Data."> <paragraph num="A."> <text>A non-hospital health care facility shall submit accurate, timely, and complete data which the Commission considers to be necessary for planning and analysis purposes, as requested by the Commission.</text> </paragraph> <paragraph num="B."> <text>The information requested by the Commission may include, but is not limited to, the following types of information:</text> <paragraph num="(1)"> <text>Aggregate facility data as follows:</text> <paragraph num="(a)"> <text>Service configuration;</text> </paragraph> <paragraph num="(b)"> <text>Location;</text> </paragraph> <paragraph num="(c)"> <text>Operational characteristics; and</text> </paragraph> <paragraph num="(d)"> <text>Utilization; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patient-level data as follows:</text> <paragraph num="(a)"> <text>Demographic characteristics;</text> </paragraph> <paragraph num="(b)"> <text>Admission, discharge, and disposition data;</text> </paragraph> <paragraph num="(c)"> <text>Diagnosis and treatment data; and</text> </paragraph> <paragraph num="(d)"> <text>Payment source and charges.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission shall provide notice of the form, format, and schedule for data reporting by non-hospital health care facilities.</text> </paragraph> <paragraph num="D."> <text>Failure to report the data required under this regulation may subject a non-hospital health care facility to penalties under COMAR 10.25.12.</text> </paragraph> <paragraph num="E."> <text>The requirements of this chapter are in addition to any other obligation to report information to the Commission by law or as a condition on a certificate of need or other Commission approval.</text> </paragraph> <paragraph num="F."> <text>Extension.</text> <paragraph num="(1)"> <text>A non-hospital health care facility, by letter to the Executive Director of the Commission, may request an extension of its data submission date.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director of the Commission, for good cause shown, may grant an extension of a data submission date.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Summary Studies, Reports, and Compilations."> <paragraph num="A."> <text>Subject to §B of this regulation, summary studies, reports, or other compilations developed by the Commission from the data submitted in accordance with this chapter are public information.</text> </paragraph> <paragraph num="B."> <text>Disclosure under §A of this regulation may not be made in such a way that the data furnished for a specific patient can be identified.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109 and 19-116, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 22, 2025 (52:25 Md. R. 1268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 22, 2025 (52:25 Md. R. 1268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 recodified from Regulation .04 effective December 22, 2025 (52:25 Md. R. 1268)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed effective December 22, 2025 (52:25 Md. R. 1268)</annotation> </annotations> </chapter> <chapter num="07" heading="State Health Plan for Facilities and Services: Residential Treatment Centers"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Residential Treatment Centers is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (3), 19-118, and 19-120, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 8, 1980 (7:3 Md. R. 264)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 26, 1981 (8:13 Md. R. 1140) and October 12, 1981 (8:20 Md. R. 1635)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.48.01 to 10.24.07</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 10, 1984 (11:18 Md. R. 1584); February 9, 1987 (14:3 Md. R. 274); August 16, 1993 (20:16 Md. R. 1277)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective October 18, 1984 (11:23 Md. R. 1990); adopted permanently effective January 14, 1985 (12:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 16, 1985 (12:3 Md. R. 242); emergency status extended at 12:10 Md. R. 959; adopted permanently effective September 9, 1985 (12:18 Md. R. 1766)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 1, 1986 (13:2 Md. R. 135); emergency status extended at 13:10 Md. R. 1152; adopted permanently effective June 2, 1986 (13:11 Md. R. 1273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective April 25, 1986 (13:10 Md. R. 1152); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective August 13, 1986 (13:18 Md. R. 2017); adopted permanently effective December 15, 1986 (13:25 Md. R. 2659)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 amended and .02A repealed as an emergency provision effective April 2, 1992 (19:8 Md. R. 800); adopted permanently effective July 6, 1992 (19:13 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted as an emergency provision effective May 21, 1986 (13:12 Md. R. 1372); emergency status expired September 28, 1986 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective August 13, 1986 (13:18 Md. R. 2017); adopted permanently effective December 15, 1986 (13:25 Md. R. 2659)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 28, 1990 (17:10 Md. R. 1219)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective February 1, 1991 (18:4 Md. R. 445)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B adopted effective February 9, 1987 (14:3 Md. R. 274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 5, 1988 (15:18 Md. R. 2151); May 28, 1990 (17:10 Md. R. 1219); July 29, 1996 (23:15 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective February 27, 1997 (24:6 Md. R. 481); amended permanently effective June 30, 1997 (24:13 Md. R. 932)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 under Chapter, State Health Plan: Overview, Psychiatric Services, and Emergency Medical Services, repealed and new Regulation .01 under Chapter, State Health Plan for Facilities and Services: Residential Treatment Centers, adopted effective August 9, 2021 (48:16 Md. R. 631)</annotation> </annotations> </chapter> <chapter num="08" heading="State Health Plan for Facilities and Services: Special Hospital — Chronic Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Special Hospital — Chronic Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1), 19-118, and 19-120(f), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective February 1, 1991 (18:4 Md. R. 445); emergency status extended at 18:17 Md. R. 1911 and 19:3 Md. R. 302; emergency status superseded at 19:8 Md. R. 800, effective April 2, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective April 2, 1992 (19:8 Md. R. 800); adopted permanently effective July 6, 1992 (19:13 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 8, 1995 (22:9 Md. R. 644); May 5, 1997 (24:9 Md. R. 657); December 1, 1997 (24:24 Md. R. 1670); August 9, 1999 (26:16 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective April 15, 2002 (29:7 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 12, 2007 (34:5 Md. R. 560); October 14, 2013 (40:20 Md. R. 1652); April 11, 2016 (43:7 Md. R. 450); July 15, 2019 (46:14 Md. R. 621)</annotation> </annotations> </chapter> <chapter num="09" heading="State Health Plan for Facilities and Services: Specialized Health Care Services — Acute Inpatient Rehabilitation Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>The State Health Plan for Facilities and Services: Specialized Health Care Services — Acute Inpatient Rehabilitation Services.</text> </paragraph> <paragraph num="(2)"> <text>Supplement No. 1.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1), 19-118, and 19-120, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 (Moratorium on Certificate of Need Application) adopted as an emergency provision effective August 1, 1985 (12:17 Md. R. 1696) (12:20 Md. R. 1921); emergency status extended at 12:26 Md. R. 2540; emergency status expired March 29, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 (State Health Plan: Comprehensive Rehabilitation Services) adopted as an emergency provision effective June 10, 1987 (14:14 Md. R. 1565); emergency status expired November 10, 1987; adopted permanently effective January 25, 1988 (15:2 Md. R. 121)</annotation> <annotation type="History" subtype="Administrative History">Chapter, State Health Plan: Comprehensive Rehabilitation Services, repealed and new Regulation .01 under chapter, State Health Plan: Acute Inpatient Rehabilitation Services, adopted effective March 11, 1996 (23:5 Md. R. 379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective December 23, 2013 (40:25 Md. R. 2069)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective March 17, 2018 (45:8 Md. R. 418); amended permanently effective May 21, 2018 (45:10 Md. R. 503)</annotation> </annotations> </chapter> <chapter num="10" heading="State Health Plan for Facilities and Services: Acute Care Hospital Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Acute Care Hospital Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (3), 19-118, 19-120, and 19-126, et seq, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08, Hospital Capacity Plan, adopted as an emergency provision effective February 7, 1986 (13:5 Md. R. 526); emergency status extended at 13:22 Md. R. 2394; emergency status extended at 14:7 Md. R. 828</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, State Health Plan: Acute Inpatient Services, adopted as an emergency provision effective July 16, 1987 (14:16 Md. R. 1770); emergency status extended at 14:18 Md. R. 1962</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, State Health Plan: Acute Inpatient Services, adopted as an emergency provision effective September 23, 1987 (14:21 Md. R. 2220); adopted permanently effective February 8, 1988 (15:3 Md. R. 304)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 6, 1988 (15:16 Md. R. 1910); adopted permanently effective November 14, 1988 (15:23 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 20, 1993 (20:25 Md. R. 1947); July 1, 1996 (23:13 Md. R. 944); April 12, 2004 (31:7 Md. R. 584); April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2008 (35:25 Md. R. 2149)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective March 18, 2024 (51:5 Md. R. 229)</annotation> </annotations> </chapter> <chapter num="11" heading="State Health Plan for Facilities and Services: General Surgical Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: General Surgical Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1), 19-118, 19-120, and 19-120.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 16, 1993 (20:16 Md. R. 1277)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25); November 12, 2012 (39:22 Md. R. 1429); January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective October 18, 2021 (48:21 Md. R. 889)</annotation> </annotations> </chapter> <chapter num="12" heading="State Health Plan for Facilities and Services: Acute Hospital Inpatient Obstetric Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Acute Hospital Inpatient Obstetric Services (Supplement No. 1) is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-118(a)(2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 15, 2002 (29:7 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 28, 2005 (32:4 Md. R. 410)</annotation> </annotations> </chapter> <chapter num="13" heading="State Health Plan for Facilities and Services: Hospice Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference"> <text>The State Health Plan for Facilities and Services: Hospice Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and 19-118, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 14, 2013 (40:20 Md. R. 1652)</annotation> </annotations> </chapter> <chapter num="14" heading="State Health Plan for Facilities and Services: Alcoholism and Drug Abuse Intermediate Care Facility Treatment Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>The State Health Plan for Facilities and Services: Alcoholism and Drug Abuse Intermediate Care Facility Treatment Services.</text> </paragraph> <paragraph num="(2)"> <text>Supplement No. 1.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and 19-121, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective March 8, 1990 (17:7 Md. R. 843); emergency status extended at 17:22 Md. R. 2653 and 18:6 Md. R. 681; adopted permanently effective September 2, 1991 (18:17 Md. R. 1918)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective March 12, 1992 (19:7 Md. R. 742); amended permanently effective August 3, 1992 (19:15 Md. R. 1390)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 21, 2002 (29:1 Md. R. 23); February 18, 2013 (40:3 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective January 8, 2001 (27:26 Md. R. 2358)</annotation> </annotations> </chapter> <chapter num="15" heading="State Health Plan for Facilities and Services: Specialized Health Care Services — Organ Transplant Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Specialized Health Care Services — Organ Transplant Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-101 et seq., Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 5, 1988 (15:18 Md. R. 2152)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective January 14, 1999 (26:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 7, 2000 (27:2 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective April 15, 2002 (29:7 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective February 27, 2017 (44:4 Md. R. 254)</annotation> </annotations> </chapter> <chapter num="16" heading="State Health Plan for Facilities and Services: Home Health Agency Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Home Health Agency Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1), 19-118, and 19-120(f), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 11, 2016 (43:7 Md. R. 450)</annotation> </annotations> </chapter> <chapter num="17" heading="State Health Plan for Facilities and Services: Specialized Health Care Services — Cardiac Surgery and Percutaneous Coronary Intervention Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Specialized Health Care Services — Cardiac Surgery and Percutaneous Coronary Intervention Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a) and (3), 19-118, 19-120, and 19-120.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective December 1, 1997 (24:24 Md. R. 1670)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 14, 2001 (28:9 Md. R. 885); March 15, 2004 (31:5 Md. R. 449); August 10, 2009 (36:16 Md. R. 1251)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 14, 2012 (39:3 Md. R. 257); amended permanently effective March 19, 2012 (39:5 Md. R. 382)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 18, 2014 (41:16 Md. R. 946); November 9, 2015 (42:22 Md. R. 1378)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective January 14, 2019 (46:1 Md. R. 12)</annotation> </annotations> </chapter> <chapter num="18" heading="State Health Plan for Facilities and Services: Specialized Health Care Services — Neonatal Intensive Care Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>The State Health Plan: Specialized Health Care Services — Neonatal Intensive Care Services.</text> </paragraph> <paragraph num="(2)"> <text>Supplement No. 1.</text> </paragraph> <paragraph num="(3)"> <text>Supplement No. 2.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and 19-118, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 9, 1998 (25:3 Md. R. 145)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 14, 1998 (25:25 Md. R. 1832); October 23, 2006 (33:21 Md. R. 1676)</annotation> </annotations> </chapter> <chapter num="19" heading="State Health Plan for Facilities and Services: Freestanding Medical Facilities"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Freestanding Medical Facilities is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1), 19-114(d)(1)(viii), 19-118(a)(2)(i), 19-120(j)(2)(iv), and 19-120(o)(1) and (3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 2017 (44:12 Md. R. 587)</annotation> </annotations> </chapter> <chapter num="20" heading="State Health Plan for Facilities and Services: Comprehensive Care Facility (Nursing Home) Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Comprehensive Care Facility (Nursing Home) Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-103, 19-109(a)(1), 19-114, 19-118, 19-120, 19-120.2, 19-123, and 19-124, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 15, 2019 (46:14 Md. R. 622)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective February 17, 2025 (52:3 Md. R. 160)</annotation> </annotations> </chapter> <chapter num="21" heading="State Health Plan for Facilities and Services: Acute Psychiatric Services"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>The State Health Plan for Facilities and Services: Acute Psychiatric Services is incorporated by reference.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (3), 19-118, and 19-120, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 9, 2021 (48:16 Md. R. 631)</annotation> </annotations> </chapter> </subtitle> <subtitle num="25" heading="Maryland Health Care Commission"> <chapter num="01" heading="Small Employer Health Benefit Plan Premium Subsidy Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter only applies to the Small Employer Health Benefit Plan Premium Subsidy Program as authorized by Insurance Article, §§15-12A-01 — 15-12A-05, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Premium subsidies authorized under this chapter shall only be provided for health benefit plans that also comply with the provisions of COMAR 31.11.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affiliated companies” means companies that are eligible to file a consolidated federal income tax return.</text> </paragraph> <paragraph num="(2)"> <text>“Average wage of business” means the average of the annual wage of all eligible employees; for each eligible owner, the wage used to calculate the average for the business shall be the lesser of:</text> <paragraph num="(a)"> <text>The eligible owner's countable wage; or</text> </paragraph> <paragraph num="(b)"> <text>The eligible owner's adjusted gross income.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Carrier” has the meaning stated in Insurance Article, §15-1201(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“COMAR” means the Code of Maryland Regulations.</text> </paragraph> <paragraph num="(5)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(6)"> <text>“Commission registry” means a web-based utility by which employers and employees are enrolled in the Premium Subsidy Program.</text> </paragraph> <paragraph num="(7)"> <text>“Commission's official website” means http://mhcc.maryland.gov/.</text> </paragraph> <paragraph num="(8)"> <text>“Designated financial institution” means one or more financial institutions with whom the participating carrier has made arrangements for administration of HSAs in conjunction with the participating carrier's HSA compatible health benefit plan.</text> </paragraph> <paragraph num="(9)"> <text>“Eligible employee” means an individual who:</text> <paragraph num="(a)"> <text>Works on a full-time basis and has a normal workweek of at least 30 hours; and</text> </paragraph> <paragraph num="(b)"> <text>Is either:</text> <paragraph num="(i)"> <text>An employee;</text> </paragraph> <paragraph num="(ii)"> <text>A partner of a partnership;</text> </paragraph> <paragraph num="(iii)"> <text>An eligible owner; or</text> </paragraph> <paragraph num="(iv)"> <text>An independent contractor who is included as an employee under a health benefit plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Eligible Owner.</text> <paragraph num="(a)"> <text>“Eligible owner” means:</text> <paragraph num="(i)"> <text>A person with a 20 percent or greater financial interest in a small employer who works at least 30 hours per week for that small employer; or</text> </paragraph> <paragraph num="(ii)"> <text>An Executive Director of a nonprofit corporation that has been determined by the Internal Revenue Service to be exempt from taxation under §501(c)(3), (4), or (6) of the Internal Revenue Code who works at least 30 hours per week for that small employer.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Eligible owner” includes an eligible owner's spouse who works at least 30 hours per week for the small employer.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Eligible owner's adjusted gross income” means an amount equal to the adjusted gross income reported on the eligible owner's individual federal tax return or 50 percent of the adjusted gross income reported on the eligible owner's joint federal tax return for the most recent year.</text> </paragraph> <paragraph num="(12)"> <text>“Eligible owner's countable wage” means an amount published by the Commission used to calculate the average wage of a small employer.</text> </paragraph> <paragraph num="(13)"> <text>“Employee premium” means the amount of the premium that is paid by the employee for that employee's selected type of coverage.</text> </paragraph> <paragraph num="(14)"> <text>“Employee premium subsidy” means, for a given employee's selected type of coverage, the amount of the premium subsidy that shall be passed through to the enrolled employee by the employer in the form of reduced payroll deductions for the health benefit plan.</text> </paragraph> <paragraph num="(15)"> <text>“Employee's eligible HSA contribution” means the lesser of:</text> <paragraph num="(a)"> <text>An amount published by the Commission; or</text> </paragraph> <paragraph num="(b)"> <text>An employee's contribution to an HSA, made through regular payroll deductions deposited by the employer on behalf of the employee in the employee's HSA established at the carrier's designated financial institution.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Employee Wage.</text> <paragraph num="(a)"> <text>“Employee wage” means, for a given eligible employee, the employee's estimated annual earnings at the time of initial or renewal application for the Premium Subsidy Program, including any salary, wages, commissions, bonuses, profit sharing, and reportable tips.</text> </paragraph> <paragraph num="(b)"> <text>“Employee wage” includes, for purposes of this program, income received from an employee's ownership interest in the business.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Employer's eligible HSA contribution” means an annual contribution to an employee's HSA:</text> <paragraph num="(a)"> <text>Established at the carrier's designated financial institution;</text> </paragraph> <paragraph num="(b)"> <text>Made by an employer according to a commitment made at enrollment or renewal;</text> </paragraph> <paragraph num="(c)"> <text>Equal for all employees choosing a given HSA-compatible health benefit plan; and</text> </paragraph> <paragraph num="(d)"> <text>Contributed either in a single payment at the beginning of the policy year or in equal installments throughout the policy year.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Enrolled employee” means an eligible employee approved by the Commission to receive the premium subsidy.</text> </paragraph> <paragraph num="(19)"> <text>“Enrolled employer” means a small employer approved by the Commission to receive the premium subsidy.</text> </paragraph> <paragraph num="(20)"> <text>“Family” has the meaning stated in COMAR 31.11.06.02B(19).</text> </paragraph> <paragraph num="(21)"> <text>Family Adjusted Gross Income.</text> <paragraph num="(a)"> <text>“Family adjusted gross income” means, for an unmarried employee and for a married employee filing jointly, the adjusted gross income reported on the employee's most recent federal tax return.</text> </paragraph> <paragraph num="(b)"> <text>“Family adjusted gross income”, for a married employee filing separately, means the sum of the adjusted gross income reported on the employee's most recent federal tax return and the adjusted gross income reported on the most recent federal tax return of the employee's spouse.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Health benefit plan” has the meaning stated in Insurance Article, §15-1201(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Health insurance” has the meaning stated in Insurance Article, §1-101(p), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Health savings account (HSA)” means a health savings account as defined in the Medicare Prescription Drug, Improvement and Modernization Act of 2003, Title 12, §1201(a), as codified at Part VII, Subchapter B, Chapter 1, §223(d) of the Internal Revenue Code.</text> </paragraph> <paragraph num="(25)"> <text>“Individual coverage” means a health benefit plan that insures an individual employee only.</text> </paragraph> <paragraph num="(26)"> <text>“Initial application” means a subsidy applicant's first application to receive the premium subsidy.</text> </paragraph> <paragraph num="(27)"> <text>“Licensed insurance producer” has the meaning stated in Insurance Article, §1-101(w), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(28)"> <text>“Maximum average wage for new applications” means an amount published by the Commission that represents the maximum average annual wage at which an employer not currently participating in the Premium Subsidy Program is eligible to apply for participation.</text> </paragraph> <paragraph num="(29)"> <text>“Maximum average wage for participants” means an amount published by the Commission that represents the maximum average annual wage, calculated at time of renewal, at which an enrolled employer may continue to participate in the Premium Subsidy Program.</text> </paragraph> <paragraph num="(30)"> <text>“Maximum eligible firm size” means a number published by the Commission that represents the largest number of eligible employees a small business may have at the time of policy renewal and still be eligible for participation in the Premium Subsidy Program.</text> </paragraph> <paragraph num="(31)"> <text>“Maximum income for other than individual coverage” means an amount published by the Commission that represents the maximum family adjusted gross income at which an eligible employee may receive a premium subsidy for other than individual coverage.</text> </paragraph> <paragraph num="(32)"> <text>“Maximum subsidy table” means a table published by the Commission that describes, for each type of coverage and average wage of business, the maximum premium subsidy that may be provided for each employee electing that type of coverage.</text> </paragraph> <paragraph num="(32-1)"> <text>“Minimum countable wage” means an amount published by the Commission that represents the minimum annual wage for an eligible employee that can be used to calculate the average wage of a small employer.</text> </paragraph> <paragraph num="(33)"> <text>“Other than individual coverage” means the following types of coverage:</text> <paragraph num="(a)"> <text>Individual plus children;</text> </paragraph> <paragraph num="(b)"> <text>Individual plus spouse; or</text> </paragraph> <paragraph num="(c)"> <text>Individual plus children and spouse.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Participating carrier” means a carrier who:</text> <paragraph num="(a)"> <text>Participates in the Maryland small group market as defined under COMAR 31.11.06;</text> </paragraph> <paragraph num="(b)"> <text>Agrees to offer a qualifying health plan; and</text> </paragraph> <paragraph num="(c)"> <text>Enters into a written participation agreement with the Commission.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Policy” has the meaning stated in Insurance Article, §1-101(ee), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(36)"> <text>“Policy year” means a 365-day period that begins on the policy's effective date or a period of 1 full calendar-year, under a health benefit plan providing coverage to employers and their employees, as defined in the policy.</text> </paragraph> <paragraph num="(37)"> <text>“Premium” has the meaning stated in Insurance Article, §1-101(ff), Annotated Code of Maryland, applied to a given employee's selected type of coverage.</text> </paragraph> <paragraph num="(38)"> <text>“Premium subsidy” means the amount paid to the participating carrier by the State in order to reduce the premium paid by the enrolled employer for a given eligible employee's selected type of coverage.</text> </paragraph> <paragraph num="(39)"> <text>“Premium Subsidy Program” means the Small Employer Health Benefit Plan Premium Subsidy Program, as defined in Insurance Article, §15-12A-02, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(40)"> <text>“Prominent carrier” means a carrier that insures at least 10 percent of the total lives insured in the small group market.</text> </paragraph> <paragraph num="(41)"> <text>“Qualifying health plan” means a Comprehensive Standard Health Benefit Plan, as defined under COMAR 31.11.06, together with riders, that includes a wellness benefit defined in Insurance Article, §15-1201(s), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(42)"> <text>“Quarterly wage reports” means the reporting of wages on quarterly employment reports as described in COMAR 09.32.01.14.</text> </paragraph> <paragraph num="(43)"> <text>“Renewal application” means an application designated by the Commission for applying for renewal of the premium subsidy.</text> </paragraph> <paragraph num="(44)"> <text>“Section 125 Payroll Deduction Plan” means a payroll deduction plan pursuant to §125 of the Internal Revenue Code.</text> </paragraph> <paragraph num="(45)"> <text>“Size factor” means a factor published by the Commission, based on the number of eligible employees of a small employer at the time of policy renewal, and used to calculate the premium subsidy.</text> </paragraph> <paragraph num="(46)"> <text>“Small employer” has the meaning stated in Insurance Article, §15-1201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(47)"> <text>“Subsidy administrator” means one or more entities:</text> <paragraph num="(a)"> <text>Designated by the participating carrier to administer enrollment, registration, billing, accounting, or reconciliation on behalf of the participating carrier; and</text> </paragraph> <paragraph num="(b)"> <text>That is either a component of the carrier organization, or a separate entity under contract with the participating carrier that is bonded and subject to audit by the participating carrier and the Commission.</text> </paragraph> </paragraph> <paragraph num="(48)"> <text>“Subsidy applicant” means either an employer or employee applying to receive the premium subsidy.</text> </paragraph> <paragraph num="(49)"> <text>“Subsidy application” means an application designated by the Commission to be completed, signed, and submitted in order for the Commission to determine eligibility for the Premium Subsidy Program.</text> </paragraph> <paragraph num="(50)"> <text>“Subsidy program cap” means a dollar amount published by the Commission that represents the Commission's estimate of the total annualized subsidy payment that is sustainable.</text> </paragraph> <paragraph num="(51)"> <text>“Total premium” means the sum of all premiums for coverage under the employer's health benefit plan.</text> </paragraph> <paragraph num="(52)"> <text>“Total premium subsidy” means the sum of all premium subsidies for coverage under the employer's health benefit plan.</text> </paragraph> <paragraph num="(53)"> <text>“Type of coverage” means the choice of coverage for each eligible employee's health benefit plan, specifically:</text> <paragraph num="(a)"> <text>Individual only;</text> </paragraph> <paragraph num="(b)"> <text>Individual plus children;</text> </paragraph> <paragraph num="(c)"> <text>Individual plus spouse; or</text> </paragraph> <paragraph num="(d)"> <text>Individual plus children and spouse.</text> </paragraph> </paragraph> <paragraph num="(54)"> <text>“Wellness benefit” has the meaning stated in Insurance Article, §15-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(55)"> <text>“Written participation agreement” means a contract between a participating carrier and the Commission that defines:</text> <paragraph num="(a)"> <text>The terms and conditions of the participating carrier's involvement in the Premium Subsidy Program; and</text> </paragraph> <paragraph num="(b)"> <text>The roles and responsibilities of the subsidy administrator in administering the Premium Subsidy Program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Purpose."> <text>The Premium Subsidy Program is designed to:</text> <paragraph num="A."> <text>Provide an incentive for small employers to offer and maintain a small employer health benefit plan for their employees;</text> </paragraph> <paragraph num="B."> <text>Help low and moderate wage employees of small employers afford health benefit plan premiums;</text> </paragraph> <paragraph num="C."> <text>Promote access to health care services, particularly preventive health care services that might reduce the need for emergency room care and other acute care services; and</text> </paragraph> <paragraph num="D."> <text>Reduce uncompensated care in hospitals and other health care settings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Employer Eligibility."> <paragraph num="A."> <text>A small employer is eligible to receive a premium subsidy if, at the time of initial application for the premium subsidy, the employer:</text> <paragraph num="(1)"> <text>Meets the requirements under Insurance Article, §15-1203(b)(i), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Has been in operation for at least 12 months and, if required to file quarterly wage reports, has filed quarterly wage reports with the Maryland Department of Labor for, at a minimum, the three calendar quarters immediately preceding initial application for the premium subsidy;</text> </paragraph> <paragraph num="(3)"> <text>Has not offered a health benefit plan to its employees for at least 12 consecutive months immediately before initial application for the premium subsidy;</text> </paragraph> <paragraph num="(4)"> <text>Employed at least two but not more than nine eligible employees:</text> <paragraph num="(a)"> <text>At the time the employer's subsidy application is entered into the Commission registry; and</text> </paragraph> <paragraph num="(b)"> <text>On at least 50 percent of its working days during the preceding calendar quarter;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Has an average wage of business that does not exceed the maximum average wage for new applications;</text> </paragraph> <paragraph num="(6)"> <text>Agrees to offer a health benefit plan to its eligible employees that contains a wellness benefit;</text> </paragraph> <paragraph num="(7)"> <text>Commits to establish a Section 125 payroll deduction plan within 60 days of enrollment in the Premium Subsidy Program;</text> </paragraph> <paragraph num="(8)"> <text>Completes and signs the subsidy application; and</text> </paragraph> <paragraph num="(9)"> <text>Complies with the other regulations of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Affiliated companies are considered one employer for purposes of this chapter.</text> </paragraph> <paragraph num="C."> <text>An enrolled employer is eligible to continue receiving a premium subsidy if, at the time of the renewal application, the employer:</text> <paragraph num="(1)"> <text>Has filed quarterly wage reports with the Maryland Department of Labor for, at a minimum, the three calendar quarters immediately preceding the renewal application for the premium subsidy;</text> </paragraph> <paragraph num="(2)"> <text>Has at least two eligible employees and the number of eligible employees is not more than the maximum eligible firm size;</text> </paragraph> <paragraph num="(3)"> <text>Has an average wage of business that does not exceed the maximum average wage for participants;</text> </paragraph> <paragraph num="(4)"> <text>Continues to offer a health benefit plan to its eligible employees that contains a wellness benefit;</text> </paragraph> <paragraph num="(5)"> <text>Has an established Section 125 payroll deduction plan in place for at least 10 months;</text> </paragraph> <paragraph num="(6)"> <text>Completes and signs the subsidy application; and</text> </paragraph> <paragraph num="(7)"> <text>Complies with the other regulations of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An enrolled employer whose coverage is terminated before the end of the policy year for any cause, including nonpayment of premium, is required to reapply and to meet all of the requirements for an initial application.</text> </paragraph> <paragraph num="E."> <text>If the carrier terminates the coverage but then reinstates the employer's coverage with the same premium and policy expiration date, the employer shall be reinstated in the Premium Subsidy Program without reapplication.</text> </paragraph> <paragraph num="F."> <text>Retroactive payments made by a small employer who is terminated and then reinstated by a carrier during a policy year are eligible for a premium subsidy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Employee Eligibility."> <paragraph num="A."> <text>An eligible employee of a small employer is eligible to receive the premium subsidy if, at the time of initial application and at the time of each renewal application:</text> <paragraph num="(1)"> <text>The small employer meets the requirements of Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The eligible employee enrolls in a health benefit plan offered by the small employer;</text> </paragraph> <paragraph num="(3)"> <text>The eligible employee completes and signs the subsidy application; and</text> </paragraph> <paragraph num="(4)"> <text>The eligible employee complies with the regulations of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An eligible employee applying for a premium subsidy for other than individual coverage shall satisfy the conditions described in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>At the time of initial application for the premium subsidy and at the time of each renewal application, each employee subsidy applicant shall complete, sign, and submit to a licensed insurance producer a form designated by the Commission which includes the following information:</text> <paragraph num="(1)"> <text>The type of coverage selected by the employee subsidy applicant;</text> </paragraph> <paragraph num="(2)"> <text>Information requested by the Commission about any insurance coverage carried by the employee subsidy applicant or the applicant's family members during the 3 months immediately before the employee subsidy applicant's initial application for the premium subsidy;</text> </paragraph> <paragraph num="(3)"> <text>Acknowledgement that the employee subsidy applicant's share of the premium will be deducted through a Section 125 payroll deduction plan;</text> </paragraph> <paragraph num="(4)"> <text>If other than individual coverage is sought, an affidavit regarding the family's adjusted gross income and an agreement to provide documentation of the family's adjusted gross income to the Commission on request; and</text> </paragraph> <paragraph num="(5)"> <text>Other information considered appropriate by the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Unless allowed under Regulation .08 of this chapter, the following individuals are ineligible to receive a premium subsidy:</text> <paragraph num="(1)"> <text>A former employee eligible for Continuation of Coverage under COMAR 31.11.04;</text> </paragraph> <paragraph num="(2)"> <text>Divorced spouses eligible for Continuation of Coverage under COMAR 31.11.02; and</text> </paragraph> <paragraph num="(3)"> <text>Surviving spouses eligible for Continuation of Coverage under COMAR 31.11.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Employee Selection of Other Than Individual Coverage."> <paragraph num="A."> <text>An eligible employee may apply for a premium subsidy for other than individual coverage if the eligible employee's family adjusted gross income does not exceed the maximum income for other than individual coverage.</text> </paragraph> <paragraph num="B."> <text>An eligible employee applying for a premium subsidy for other than individual coverage shall comply with requirements considered necessary by the Commission to verify the reported family adjusted gross income.</text> </paragraph> <paragraph num="C."> <text>An eligible employee with a family adjusted gross income greater than the maximum income for other than individual coverage is eligible for the premium subsidy for individual coverage if the eligible employee satisfies the conditions of Regulation .05 of this chapter.</text> </paragraph> <paragraph num="D."> <text>If a carrier offers coverage for domestic partners and the employer selects that coverage, a domestic partner is a spouse for the purposes of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Initial Application and Enrollment."> <paragraph num="A."> <text>Initial application for the Premium Subsidy Program shall be made according to the procedures designated by the Commission and published on the Commission's official website.</text> </paragraph> <paragraph num="B."> <text>The small employer shall complete an initial application published on the Commission's official website that includes the following:</text> <paragraph num="(1)"> <text>Information necessary to establish the eligibility of the small employer and the amount of the available subsidy;</text> </paragraph> <paragraph num="(2)"> <text>An agreement by the small employer that the employer will establish a Section 125 payroll deduction plan within 60 days of enrollment;</text> </paragraph> <paragraph num="(3)"> <text>An acknowledgement that:</text> <paragraph num="(a)"> <text>The Commission may employ an auditor to examine an enrolled employer's records to determine the accuracy of statements made on the application;</text> </paragraph> <paragraph num="(b)"> <text>Incorrect statements may be cause for exclusion from the Premium Subsidy Program; and</text> </paragraph> <paragraph num="(c)"> <text>Fraudulent applications may be referred for prosecution;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An agreement to cooperate fully with the Commission and the Commission's auditor; and</text> </paragraph> <paragraph num="(5)"> <text>An affidavit signed by the small employer that the information in the initial application is correct and that the small employer meets the eligibility criteria for receipt of a premium subsidy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The initial application shall include an affirmation signed by the licensed insurance producer that:</text> <paragraph num="(1)"> <text>The health benefit plan or plans selected by the small employer include a wellness benefit;</text> </paragraph> <paragraph num="(2)"> <text>The licensed insurance producer has examined the small employer's most recent Quarterly Wage Report, and the information in the initial application is consistent with that report; and</text> </paragraph> <paragraph num="(3)"> <text>To the best of the licensed insurance producer's knowledge, the information in the initial application is correct.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The initial application for each employee shall include the following:</text> <paragraph num="(1)"> <text>Information about any private or public health insurance program that provided coverage at any time during the preceding 3 months for the employee or any of the employee's dependents who will be insured under the health benefit plan; and</text> </paragraph> <paragraph num="(2)"> <text>For other than individual coverage:</text> <paragraph num="(a)"> <text>An affidavit that the employee's family adjusted gross income is less than or equal to the maximum income for other than individual coverage; and</text> </paragraph> <paragraph num="(b)"> <text>An agreement to provide copies of relevant tax return forms, if requested by the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The participating carrier's procedures and written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the initial application in the Commission registry to register the small employer to receive a premium subsidy.</text> </paragraph> <paragraph num="F."> <text>The Commission registry will generate:</text> <paragraph num="(1)"> <text>A registration number;</text> </paragraph> <paragraph num="(2)"> <text>The total premium subsidy that the participating carrier shall provide to the small employer in the form of a reduced total premium;</text> </paragraph> <paragraph num="(3)"> <text>The amount of premium subsidy for each employee that the small employer shall pass through in the form of reduced payroll deductions for health benefits; and</text> </paragraph> <paragraph num="(4)"> <text>Other information that the Commission may consider useful for administration of the Premium Subsidy Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Application and Enrollment of Additional Employees During the Policy Year."> <paragraph num="A."> <text>A newly hired eligible employee of an enrolled employer, an employee who becomes an eligible employee during the policy year, or an eligible employee who qualifies for a special enrollment period under 29 U.S.C. §1181(f) is eligible to be enrolled in the Premium Subsidy Program during the policy year under the terms established at the beginning of the policy year, unless either:</text> <paragraph num="(1)"> <text>The participating carrier recalculates premiums charged to the enrolled employer; or</text> </paragraph> <paragraph num="(2)"> <text>The Premium Subsidy Program is closed to registration of additional employees of enrolled employers under Regulation .19 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The additional employee shall complete and sign the employee subsidy application required under Regulation .07 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The participating carrier's procedures and the written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the additional employee's subsidy application in the Commission registry to register the additional employee to receive the premium subsidy.</text> </paragraph> <paragraph num="D."> <text>If the participating carrier recalculates the premium rates charged to the enrolled employer, the employer shall complete the renewal application required under Regulation .09 of this chapter, including information about all current eligible employees. In this case, the total premium subsidy shall be recalculated for the small employer and eligible employees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Renewal Application."> <paragraph num="A."> <text>The enrolled employer shall complete a renewal application published on the Commission's official website. The renewal application shall include:</text> <paragraph num="(1)"> <text>Information necessary to establish the eligibility of the employer and the amount of the available premium subsidy;</text> </paragraph> <paragraph num="(2)"> <text>An acknowledgement that the Commission may request that certain records be produced and made available;</text> </paragraph> <paragraph num="(3)"> <text>An affidavit signed by the enrolled employer that the information in the renewal application is correct and that the enrolled employer meets the eligibility criteria for receipt of a premium subsidy; and</text> </paragraph> <paragraph num="(4)"> <text>An affidavit signed by the enrolled employer that the enrolled employer has had a Section 125 payroll deduction plan in place over the 10-month period immediately preceding the planned date of premium subsidy renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The renewal application shall include an affirmation signed by the licensed insurance producer that:</text> <paragraph num="(1)"> <text>The health benefit plan or plans selected by the enrolled employer include a wellness benefit;</text> </paragraph> <paragraph num="(2)"> <text>The licensed insurance producer has examined the enrolled employer's most recent Quarterly Wage Report, and the information in the renewal application is consistent with that report; and</text> </paragraph> <paragraph num="(3)"> <text>To the best of the licensed insurance producer's knowledge, the information in the renewal application is correct.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The renewal application shall include a signed form from each employee applying for the Premium Subsidy Program who was either not insured under the employer's health benefit plan during the previous policy year or who is changing coverage from individual coverage to other than individual coverage. The form shall include:</text> <paragraph num="(1)"> <text>Information about any private or public health insurance program that provided coverage at any time during the preceding 3 months for the employee or any of the employee's dependents who will be covered under the enrolled employer's health benefit plan; and</text> </paragraph> <paragraph num="(2)"> <text>If the type of coverage is for other than individual coverage:</text> <paragraph num="(a)"> <text>An affidavit that the employee's family adjusted gross income is less than the maximum income for other than individual coverage; and</text> </paragraph> <paragraph num="(b)"> <text>An agreement to provide copies of relevant tax return forms, if requested by the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Commission's registry will generate:</text> <paragraph num="(1)"> <text>A registration number;</text> </paragraph> <paragraph num="(2)"> <text>The total premium subsidy that the participating carrier shall provide to the small employer in the form of reduced total premium;</text> </paragraph> <paragraph num="(3)"> <text>Total premium subsidy for each enrolled employee that the small employer shall pass through in the form of reduced payroll deductions for health benefits; and</text> </paragraph> <paragraph num="(4)"> <text>Other information that the Commission may consider useful for administration of the Premium Subsidy Program.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The participating carrier's procedures and written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the renewal application in the Commission registry to register the enrolled employer to receive a premium subsidy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Calculation of the Average Wage of Business."> <paragraph num="A."> <text>The average wage of business is the average of the wage for each of the eligible employees of the business.</text> </paragraph> <paragraph num="B."> <text>For employees who are eligible owners, the wage used in calculating the average wage of business shall be the greater of the following:</text> <paragraph num="(1)"> <text>The lesser of:</text> <paragraph num="(a)"> <text>The eligible owner's countable wage; or</text> </paragraph> <paragraph num="(b)"> <text>The eligible owner's adjusted gross income; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The minimum countable wage.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For all other eligible employees, the wage used in calculating the average wage of business is the greater of:</text> <paragraph num="(1)"> <text>The employee wage; or</text> </paragraph> <paragraph num="(2)"> <text>The minimum countable wage.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Calculation of the Premium Subsidy."> <paragraph num="A."> <text>At the time of initial application for the Premium Subsidy Program, the premium subsidy is the lower of:</text> <paragraph num="(1)"> <text>The amount from the maximum subsidy table applicable for the average wage of business and the type of coverage chosen by the employee; or</text> </paragraph> <paragraph num="(2)"> <text>50 percent of the sum of:</text> <paragraph num="(a)"> <text>The premium for the type of coverage chosen by the eligible employee;</text> </paragraph> <paragraph num="(b)"> <text>The employer's eligible HSA contribution, if any; and</text> </paragraph> <paragraph num="(c)"> <text>The employee's eligible HSA contribution, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>At the time of renewal application for the Premium Subsidy Program, the premium subsidy is the lower of:</text> <paragraph num="(1)"> <text>The amount from the maximum subsidy table applicable for the average wage of business and the type of coverage chosen by the employee, multiplied by the size factor for the number of eligible employers; or</text> </paragraph> <paragraph num="(2)"> <text>50 percent of the sum of:</text> <paragraph num="(a)"> <text>The premium for the type of coverage chosen by the eligible employee;</text> </paragraph> <paragraph num="(b)"> <text>The employer's eligible HSA contribution, if any; and</text> </paragraph> <paragraph num="(c)"> <text>The employee's eligible HSA contribution, if any.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>For each health benefit plan offered by an enrolled employer, the premium subsidy remains constant throughout the policy year unless the premium changes during the policy year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Change in Employer's Federal Employer Identification Number."> <text>If the federal employer identification number of the employer changes, because the company changes its form of ownership or for any other reason, the company may petition the Commission for continued eligibility for the Premium Subsidy Program under the new federal employer identification number. The Executive Director shall rule on the petition within 14 days of the receipt of all information necessary to make the determination of continued eligibility.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Change of Participating Carrier by the Enrolled Employer."> <paragraph num="A."> <text>If the enrolled employer elects to change coverage from one participating carrier to a different participating carrier at the time of policy renewal and premium subsidy renewal, the enrolled employer shall identify the new carrier in the renewal application.</text> </paragraph> <paragraph num="B."> <text>If the enrolled employer elects to change coverage from one participating carrier to a different participating carrier at any time other than the time of policy renewal and premium subsidy renewal, the enrolled employer shall notify the Commission at least 30 days in advance of the change and shall complete the renewal application specified under Regulation .09 of the chapter for the new health benefit plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Payment of the Premium Subsidy."> <paragraph num="A."> <text>Payment of the total premium subsidy is subject to the following:</text> <paragraph num="(1)"> <text>The total premium subsidy for each enrolled employer shall be paid to the subsidy administrator and shall reduce the total premium owed by the enrolled employer;</text> </paragraph> <paragraph num="(2)"> <text>The enrolled employer shall pass the employee premium subsidy to the enrolled employee in the form of reduced payroll deductions for the health benefit plan;</text> </paragraph> <paragraph num="(3)"> <text>The employee premium subsidy is calculated as the premium subsidy for that employee's coverage multiplied by the ratio of the sum of the employee premium plus the employee's eligible HSA contribution, if any, to the sum of the premium, the employer's eligible HSA contribution, if any, and the employee's eligible HSA contribution, if any;</text> </paragraph> <paragraph num="(4)"> <text>Each month, the subsidy administrator or participating carrier shall invoice the enrolled employer for the total premium due for the subsequent month, minus the subsidy amount for enrolled employees registered in the Commission registry;</text> </paragraph> <paragraph num="(5)"> <text>At the time the enrolled employer is invoiced for the premium by the subsidy administrator or participating carrier, the subsidy administrator or participating carrier shall submit an invoice to the Commission, in a format set forth in the written participation agreement between the Commission and the participating carrier, that lists, for each enrolled employer, the invoiced premium and the premium subsidy due for each enrolled employee;</text> </paragraph> <paragraph num="(6)"> <text>The Commission shall promptly forward the invoice to the Comptroller for payment of the premium subsidy to the subsidy administrator or participating carrier;</text> </paragraph> <paragraph num="(7)"> <text>The subsidy payment is accounted for separately from other funds and is not considered to be earned by the participating carrier until the participating carrier has received the corresponding premium payment from the enrolled employer; and</text> </paragraph> <paragraph num="(8)"> <text>Each month, the subsidy administrator or participating carrier shall provide to the Commission, in a format set forth in the written participation agreement between the Commission and the participating carrier, the following:</text> <paragraph num="(a)"> <text>A list of all premium payments received from enrolled employers during the previous month, including the coverage period for which each premium payment was made; and</text> </paragraph> <paragraph num="(b)"> <text>A list of the enrolled employees covered by each premium payment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Each premium subsidy paid in advance to a participating carrier that does not correspond to an enrolled employer's premium payment shall be deducted from a subsequent premium subsidy paid to the participating carrier, and a reconciliation statement shall be provided by the Commission to the participating carrier.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Carrier Requirements."> <paragraph num="A."> <text>To participate in the Premium Subsidy Program, a carrier shall meet the definition of a participating carrier under Regulation .02B(34) of this chapter.</text> </paragraph> <paragraph num="B."> <text>The written participation agreement shall include:</text> <paragraph num="(1)"> <text>The carrier's designation of its subsidy administrator or administrators;</text> </paragraph> <paragraph num="(2)"> <text>The Commission's requirement for monthly data submissions regarding premium subsidy recipients covered by the participating carrier; and</text> </paragraph> <paragraph num="(3)"> <text>The participating carrier's agreement to cooperate with any audits of the Premium Subsidy Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A participating carrier may not condition the sale of a wellness benefit to a small employer based on participation of the eligible employees of that small employer in wellness programs or activities.</text> </paragraph> <paragraph num="D."> <text>A prominent carrier shall offer at least one health benefit plan to a small employer who meets the requirements described in Regulation .04 of this chapter and shall enter into a written participation agreement with the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Licensed Insurance Producer Requirements."> <text>A licensed insurance producer in connection with the sale, solicitation, or negotiation of a health benefit plan to a small employer who meets the requirements described in Regulation .04 of this chapter shall:</text> <paragraph num="A."> <text>Provide information to the small employer about wellness benefits;</text> </paragraph> <paragraph num="B."> <text>At the time of initial application or at the time of policy renewal, advise the small employer to consult a tax advisor about the tax advantages of a Section 125 payroll deduction plan;</text> </paragraph> <paragraph num="C."> <text>For small employers providing an HSA compatible health benefit plan to their employees, advise the small employers of the designated financial institution required to be utilized for administration of the employee's HSA account, if the HSA contributions are to be included in the calculation of the total premium subsidy; and</text> </paragraph> <paragraph num="D."> <text>Ensure completion of the required employer and employee applications including any required affidavits, and forward the original copies of the applications to the carrier's subsidy administrator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Premium Subsidy Program Design Factors."> <paragraph num="A."> <text>At least once each year, the Commission shall publish on the Commission's official website for informal public comment a list of the proposed Premium Subsidy Program design factors, including:</text> <paragraph num="(1)"> <text>Eligible owner's countable wage;</text> </paragraph> <paragraph num="(2)"> <text>Employee's eligible HSA contribution;</text> </paragraph> <paragraph num="(3)"> <text>Maximum average wage for new applications;</text> </paragraph> <paragraph num="(4)"> <text>Maximum average wage for participants;</text> </paragraph> <paragraph num="(5)"> <text>Maximum eligible firm size;</text> </paragraph> <paragraph num="(6)"> <text>Maximum income for other than individual coverage;</text> </paragraph> <paragraph num="(7)"> <text>Maximum subsidy table;</text> </paragraph> <paragraph num="(8)"> <text>Minimum countable wage;</text> </paragraph> <paragraph num="(9)"> <text>Size factor; and</text> </paragraph> <paragraph num="(10)"> <text>Subsidy program cap.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Proposed components of the Premium Subsidy Program may be based on a number of factors including, but not limited to:</text> <paragraph num="(1)"> <text>Current and projected enrollment in the Premium Subsidy Program;</text> </paragraph> <paragraph num="(2)"> <text>Current and projected demographics of enrolled employers and enrolled employees in the Premium Subsidy Program;</text> </paragraph> <paragraph num="(3)"> <text>Enrollment rate by small employers and eligible employees;</text> </paragraph> <paragraph num="(4)"> <text>Inflation;</text> </paragraph> <paragraph num="(5)"> <text>Changes in premiums;</text> </paragraph> <paragraph num="(6)"> <text>Appropriations for the Premium Subsidy Program by the Maryland General Assembly;</text> </paragraph> <paragraph num="(7)"> <text>Any surplus amounts in the Premium Subsidy Program; and</text> </paragraph> <paragraph num="(8)"> <text>Any projected shortages in the Premium Subsidy Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Following the informal public comment period, the Commission shall consider the public comments received, adopt revisions that the Commission considers appropriate, and publish the revisions on the Commission's official website and in the Maryland Register.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Closing the Premium Subsidy Program to the Entry of New Businesses."> <paragraph num="A."> <text>The Executive Director may close the program to the entry of new businesses by closing the Commission registry to new registration, notifying the participating carriers, and posting notice on the Commission's official website.</text> </paragraph> <paragraph num="B."> <text>This action shall be taken when the subsidies for the coming year are projected to reach or exceed the subsidy program cap, and may be taken at other times for reasons that the Executive Director considers sufficient.</text> </paragraph> <paragraph num="C."> <text>Advance notice of this action is desirable, but not required.</text> </paragraph> <paragraph num="D."> <text>This action shall be reviewed by the Commission at its next meeting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Closing the Premium Subsidy Program to the Entry of Additional Employees of Enrolled Employers."> <paragraph num="A."> <text>The Executive Director may close the Premium Subsidy Program to the entry of new employees by closing the Commission registry to registration of additional employees, notifying the participating carriers and enrolled employers, and posting notice on the Commission's official website.</text> </paragraph> <paragraph num="B."> <text>This action shall be reviewed by the Commission at its next meeting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Reopening the Premium Subsidy Program."> <paragraph num="A."> <text>Following closure of the Premium Subsidy Program under Regulation .18 or .19 of this chapter, the Commission may reopen the Premium Subsidy Program through a formal action specifying both the application process and the criteria that will be used to select new participants from among those applying. Selection criteria may include the average wage of the business, the geographic distribution of enrolled employers, or any other factor formally designated by the Commission.</text> </paragraph> <paragraph num="B."> <text>The Commission shall notify the participating carriers and shall post notice on the Commission's official website of the reopening of the Premium Subsidy Program. If the Premium Subsidy Program was closed under Regulation .19 of this chapter, the Commission shall also notify enrolled employers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Penalties."> <paragraph num="A."> <text>In any conduct relating to the Premium Subsidy Program, employers, employees, participating carriers, subsidy administrators, and licensed insurance producers are subject to criminal and civil penalties under applicable law for any knowing and willful making of a materially false or fraudulent statement and the knowing and willful use of a false or fraudulent document.</text> </paragraph> <paragraph num="B."> <text>Employers, employees, participating carriers, subsidy administrators, and licensed insurance producers deemed by the Commission to be in violation of this chapter may be temporarily or permanently excluded from participation in the Premium Subsidy Program by the Commission.</text> </paragraph> <paragraph num="C."> <text>If temporarily excluded from the Premium Subsidy Program by the Commission, an enrolled employer and its enrolled employees are not eligible for the Premium Subsidy Program for 12 months and must requalify for the Premium Subsidy Program at the time of reapplication.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Decisions of the Commission — Delegation of Program Administration to the Executive Director."> <paragraph num="A."> <text>Decisions of the Commission relating to policies, regulations, and program design under Regulations .17 — .20 of this chapter may not be delegated.</text> </paragraph> <paragraph num="B."> <text>All other decisions of the Commission regarding program administration, including determinations of eligibility under Regulations .04, .05, .06, .12, and 13 of this chapter, subsidy calculations under Regulation .11 of this chapter, and penalties under Regulation .21 of this chapter are delegated to the Executive Director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Appeals of Decisions of the Executive Director."> <paragraph num="A."> <text>Decisions of the Executive Director may be appealed to the Commission.</text> </paragraph> <paragraph num="B."> <text>The appeal shall be in writing and filed with the Commission within 30 days of the date of the decision of the Executive Director.</text> </paragraph> <paragraph num="C."> <text>The appeal shall state specifically the facts of the situation and the justification for the Commission to change the decision of the Executive Director. The appeal may:</text> <paragraph num="(1)"> <text>Present significant, relevant information that was not previously presented to the Commission and that, with reasonable diligence, could not have been presented before the Executive Director made a decision;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate that there have been significant changes in factors or circumstances relied upon by the Executive Director in reaching the decision; or</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate that the Executive Director has materially failed to follow the Commission's adopted procedures in reaching the decision.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Within 15 days of the filing of the appeal, the Executive Director shall submit a written response to the appeal and send it to the appellant. The appellant shall have 10 days to submit a written response for consideration by the Commission.</text> </paragraph> <paragraph num="E."> <text>The Commission may act on the appeal in one of the following ways:</text> <paragraph num="(1)"> <text>By a majority vote of the full Commission;</text> </paragraph> <paragraph num="(2)"> <text>By a majority vote of an appeals committee, whose members shall be appointed by the Chair of the Commission; or</text> </paragraph> <paragraph num="(3)"> <text>By a decision of an appeals commissioner, appointed by the Chair of the Commission.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Chair of the Commission shall determine which of the methods under §E of this regulation the Commission will use to act on the appeal.</text> </paragraph> <paragraph num="G."> <text>The Commission may act on the appeal based on the written appeal record alone, or may hold a hearing before acting on the appeal.</text> </paragraph> <paragraph num="H."> <text>The Commission may affirm, reverse, or modify the decision of the Executive Director and shall make written findings of fact and conclusions of law stating the basis for its decision within 30 days of its decision on the appeal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Appeals of Decisions of a Participating Carrier."> <text>Actions taken by a participating carrier, including actions taken by a participating carrier that affect a small employer's eligibility for participation in the Premium Subsidy Program or the amount of the premium subsidy, shall be handled through the customary appeals processes for carrier decisions and may not be appealed to the Commission.</text> </regulation> <annotations> <annotation type="Authority">Insurance Article, §§15-12A-01 — 15-12A-05, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .24 adopted as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); adopted permanently effective August 25, 2008 (35:17 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C adopted as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); adopted permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591)</annotation> </annotations> </chapter> <chapter num="02" heading="User Fee Assessment on Health Care Practitioners"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated:</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Affected licensing board” means a licensing board of which all licensees are required by the Commissioner to pay a user fee.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Health care practitioner” has the meaning stated in Health-General Article, §19-111, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Licensing board” means a unit within the Maryland Department of Health that regulates health care practitioners by the issuance and renewal of licenses to practice a health care profession.</text> </paragraph> <paragraph num="(5)"> <text>“User fee” means the amount set forth in the fee schedule that each assessed health care practitioner pays as part of a license renewal fee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Method of User Fee Assessment."> <paragraph num="A."> <text>The Commission annually shall identify the health care practitioners to be assessed a user fee.</text> </paragraph> <paragraph num="B."> <text>Based on the Commission budget, the Commission shall establish a fee schedule which sets forth the fee that each health care practitioner shall pay as part of the renewal fee required to be paid to an affected licensing board.</text> </paragraph> <paragraph num="C."> <text>The formula the Commission shall use to calculate the fee set forth in the fee schedule is 16 percent of the total assessed fees per fiscal year divided by the number of health care practitioners identified pursuant to §A of this regulation.</text> </paragraph> <paragraph num="D."> <text>The Commission shall provide the affected licensing boards with the fee schedule within sufficient time for the user fee to be included in the license renewal billing cycle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Waiver of the Fee Assessment Requirements."> <paragraph num="A."> <text>The Commission shall identify the average annual wage for health care practitioners by using comparable classifications in the State Classification and Salary Compensation Plan.</text> </paragraph> <paragraph num="B."> <text>The Commission shall determine the average annual wage by utilizing a salary range based on compensation from lowest to highest for each health care practitioner.</text> </paragraph> <paragraph num="C."> <text>The Commission shall waive the assessment for a health care practitioner whose average annual wage is substantially below that of other health care practitioners.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-111, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 6, 1994 (21:11 Md. R. 951)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 21, 2000 (27:16 Md. R. 1524); April 11, 2005 (32:7 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 18, 2002 (29:5 Md. R. 503); April 11, 2005 (32:7 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective August 21, 2000 (27:16 Md. R. 1524); April 20, 2009 (36:8 Md. R. 596); July 22, 2013 (40:14 Md. R. 1175); May 22, 2017 (44:10 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective March 18, 2002 (29:5 Md. R. 503)</annotation> </annotations> </chapter> <chapter num="03" heading="User Fee Assessment on Payers, Hospitals, and Nursing Homes"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assessment” means the total dollar amount that the Commission bills payers, hospitals, and nursing homes for a given fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Health benefit plan” has the meaning stated in Insurance Article, §15-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Nursing home” means a related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland, that is classified as a nursing home.</text> </paragraph> <paragraph num="(6)"> <text>“Payer” means a:</text> <paragraph num="(a)"> <text>Health insurer;</text> </paragraph> <paragraph num="(b)"> <text>Nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State; or</text> </paragraph> <paragraph num="(c)"> <text>Health maintenance organization that holds a certificate of authority in this State.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“User fee” means that portion of the assessment that each payer remits to the Administration pursuant to the formula established in Health-General Article, §19-111, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Method of User Fee Assessment."> <paragraph num="A."> <text>On or before June 30 of each year, the Commission shall assess each payer, hospital, and nursing home a fee in accordance with §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>Assessment of Fees.</text> <paragraph num="(1)"> <text>For each fiscal year, the Commission shall assess a fee on payers, hospitals, and nursing homes.</text> </paragraph> <paragraph num="(2)"> <text>Fees shall be assessed on each payer by apportioning the total amount of fees to be assessed payers based on the ratio of each payer's total premiums collected in the State for health benefit plans to the total collected premiums of all payers collected in the State. The apportionment shall be based on premium information reported by the Insurance Commissioner.</text> </paragraph> <paragraph num="(3)"> <text>A fee shall be assessed on each hospital that is equal to the sum of:</text> <paragraph num="(a)"> <text>The amount equal to one-half of the total fees to be assessed on hospitals under §C of this regulation times the ratio of admissions of the hospital to total admissions of all hospitals; and</text> </paragraph> <paragraph num="(b)"> <text>The amount equal to one-half of the total fees to be assessed on hospitals under §C of this regulation times the ratio of gross operating revenue of each hospital to total gross operating revenues of all hospitals.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A fee shall be assessed on each nursing home that is equal to the sum of:</text> <paragraph num="(a)"> <text>The amount equal to one-half of the total fees to be assessed on nursing homes under §C of this regulation times the ratio of admissions of the nursing home to total admissions of all nursing homes; and</text> </paragraph> <paragraph num="(b)"> <text>The amount equal to one-half of the total fees to be assessed on nursing homes under §C of this regulation times the ratio of gross operating revenue of each nursing home to total gross operating revenues of all nursing homes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>For July 1, 2023 — June 30, 2026, the amount assessed on payers may not exceed 26 percent of the total amount assessed by the Commission. The amount assessed on hospitals may not exceed 39 percent of the total amount assessed. The amount assessed on nursing homes may not exceed 19 percent of the total amount assessed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Payment of User Fees."> <paragraph num="A."> <text>On or before September 1, each payer assessed a user fee in accordance with the provisions of Health-General Article, §19-111, Annotated Code of Maryland, and this chapter shall make payment in the manner directed by the Commission.</text> </paragraph> <paragraph num="B."> <text>The Commission may make provisions upon the request of a payer for installment payments of the user fee, as the Commission considers necessary and appropriate.</text> </paragraph> <paragraph num="C."> <text>Any bill not paid within 30 days of the payment due date may be subject to an interest penalty to be determined and collected by the Commission.</text> </paragraph> <paragraph num="D."> <text>In addition to any penalties the Commission may impose on a payer, hospital, or nursing home that fails to pay the user fee in a timely manner, the Commission may refer the payer's delinquent account to the Department of Budget and Management's Central Collection Unit pursuant to the procedures in State Finance and Procurement Article, §3-301 et seq., Annotated Code of Maryland, and COMAR 17.01.01.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-111, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04 adopted as an emergency provision effective July 1, 1994 (21:15 Md. R. 1301); adopted permanently effective December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 amended as an emergency provision effective June 8, 1995 (22:13 Md. R. 965); emergency status extended at 22:20 Md. R. 1540; emergency status expired January 15, 1996; adopted permanently effective February 12, 1996 (23:3 Md. R. 168)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04 repealed and new Regulations .01 — .03 adopted effective August 21, 2000 (27:16 Md. R. 1525)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective March 18, 2002 (29:5 Md. R. 503); April 11, 2005 (32:7 Md. R. 681); April 20, 2009 (36:8 Md. R. 596); July 22, 2013 (40:14 Md. R. 1175); May 22, 2017 (44:10 Md. R. 473); July 22, 2024 (51:14 Md. R. 678)</annotation> </annotations> </chapter> <chapter num="04" heading="Hospital Quality and Performance Evaluation System"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Hospital Evaluation — Data Collection and Reporting Requirements."> <paragraph num="A."> <text>Each hospital shall file with the Commission data on measures to be included in the Commission's comparative quality and performance evaluation system and the Health Services Cost Review Commission's quality-based reimbursement initiative. The measures may be drawn from, but are not limited to, the:</text> <paragraph num="(1)"> <text>National Quality Forum;</text> </paragraph> <paragraph num="(2)"> <text>Hospital Quality Alliance;</text> </paragraph> <paragraph num="(3)"> <text>Quality Indicator Project of the Maryland Hospital Association;</text> </paragraph> <paragraph num="(4)"> <text>Agency for Healthcare Research and Quality;</text> </paragraph> <paragraph num="(5)"> <text>Hospital Quality Initiative of the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(6)"> <text>Centers for Disease Control and Prevention's National Healthcare Safety Network;</text> </paragraph> <paragraph num="(7)"> <text>Joint Commission's ORYXR initiative; or</text> </paragraph> <paragraph num="(8)"> <text>Work of academic, professional, healthcare research, and patient safety organizations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The measures shall relate to the outcomes of healthcare services and the process through which those services are delivered for the hospital as a whole as well as specific clinical areas and may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Acute myocardial infarction;</text> </paragraph> <paragraph num="(2)"> <text>Cardiac surgery and angioplasty;</text> </paragraph> <paragraph num="(3)"> <text>Emergency department care;</text> </paragraph> <paragraph num="(4)"> <text>Healthcare-associated infections;</text> </paragraph> <paragraph num="(5)"> <text>Heart failure;</text> </paragraph> <paragraph num="(6)"> <text>Maternity and newborn care;</text> </paragraph> <paragraph num="(7)"> <text>Patient experience;</text> </paragraph> <paragraph num="(8)"> <text>Patient safety;</text> </paragraph> <paragraph num="(9)"> <text>Pediatric care;</text> </paragraph> <paragraph num="(10)"> <text>Pneumonia;</text> </paragraph> <paragraph num="(11)"> <text>Health information technology; and</text> </paragraph> <paragraph num="(12)"> <text>Intensivist staffing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission shall provide notice in the Maryland Register and on its website of the form, format, and schedule for submission of data on measures to be reported to the Commission under this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Summary Studies, Reports, and Compilations."> <paragraph num="A."> <text>Subject to §B of this regulation, summary studies, reports, or other compilations of data developed by the Commission from the data submitted in accordance with this chapter are public information.</text> </paragraph> <paragraph num="B."> <text>Disclosure under §A of this regulation may not be made in such a way that the data furnished for a specific patient can be identified.</text> </paragraph> <paragraph num="C."> <text>The Commission shall publish annually, on a comparative basis, the results of the quality and performance evaluation system through one or more reports. The reports may also compare hospital performance to public health goals established by the Secretary of Health or the United States Public Health Service, United States Department of Health and Human Services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Extension of Time."> <paragraph num="A."> <text>A hospital may request an extension of time of up to 30 days for submission of data required in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Submit the request to the Executive Director of the Commission not later than 30 days before the data are due;</text> </paragraph> <paragraph num="(2)"> <text>Explain the reason for the extension request; and</text> </paragraph> <paragraph num="(3)"> <text>Propose a reasonable specific date for submission of the report.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A hospital may file a written petition with the Commission for review of a denial of an extension of time request.</text> </paragraph> <paragraph num="D."> <text>The Commission shall review the decision of the Executive Director. The Commission may affirm, reverse, or modify the decision of the Executive Director after providing the hospital with an opportunity to present its position to the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalty for Failure to File Reports."> <text>A hospital that does not timely file data may be subject to penalties described in COMAR 10.25.12.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (7) and 19-134(e), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1783)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1982)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 16, 2008 (35:12 Md. R. 1120)</annotation> </annotations> </chapter> <chapter num="05" heading="Data Release"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>This chapter addresses the requirements, parameters, administrative process, and procedures for submission, review, approval, and disapproval of requests for data from the Maryland Medical Care Data Base, any other information collected and stored in the Maryland Medical Care Data Base, and any data submitted to the Maryland Health Care Commission from a claims clearinghouse certified by the Commission that qualify as directly or indirectly individually identifiable health information, as defined in the Health Insurance Portability and Accountability Act of 1996, including all pertinent implementing regulations at 45 CFR Parts 160 and 164.</text> </paragraph> <paragraph num="B."> <text>The Commission releases data pursuant to this chapter to facilitate uses of data that are in the public interest, such as to develop public policy, promote improvement in health care access, delivery, efficiency, quality, safety, and public health outcomes, contain costs, and advance the transparency of the health care system.</text> </paragraph> <paragraph num="C."> <text>The Commission retains all ownership rights to any data released pursuant to this chapter. A recipient of data released pursuant to this chapter does not obtain any right, title, or interest in data released to a data recipient pursuant to this chapter.</text> </paragraph> <paragraph num="D."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>Requests for information from the Maryland Medical Care Data Base or any other Commission data base considered public under the Maryland Public Information Act and any other applicable laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Internal activities that are required of the Commission to conduct its lawful business of assembling the Maryland Medical Care Data Base, or any other data base that it is authorized to create and maintain;</text> </paragraph> <paragraph num="(3)"> <text>Data released to any person, governmental entity, or other entity with which the Commission has contracted pursuant to State procurement policy and laws;</text> </paragraph> <paragraph num="(4)"> <text>Data released, pursuant to the terms and conditions of a written, signed data use agreement entered into between the Commission and a State governmental entity, as defined in Regulation .02B of this chapter, that has an express statutory or regulatory mandate under Maryland law to access and use requested data;</text> </paragraph> <paragraph num="(5)"> <text>Data that the Commission is expressly authorized and required to release under applicable federal or State law requirements, provided the release of the data complies with and is limited to the relevant requirements of the applicable law.</text> </paragraph> <paragraph num="(6)"> <text>Data released pursuant to compulsory process, such as a subpoena, discovery request, warrant, or court order, issued under lawful authority in the course of litigation or an administrative proceeding before a State or federal court or administrative tribunal of competent jurisdiction, provided that prior to release of the data the Commission has made a reasonable effort to secure, or has secured, an appropriate protective order from the court or administrative tribunal, or a stipulation of the parties that:</text> <paragraph num="(a)"> <text>Prohibits the use or disclosure of the data by the parties for any purpose other than the litigation or proceeding for which the data was sought; and</text> </paragraph> <paragraph num="(b)"> <text>Requires the return of the data to the Commission or destruction of the data, including all copies of the data, at the end of the litigation or proceeding.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“All-payor claims database” or “APCD” means a large-scale database that systematically collects and aggregates enrollment, claims, and provider information from private and public payors in a state.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means a person, governmental entity, or other entity that submits an application requesting data from the Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Application” means a written request for data submitted in the form and manner specified by the Commission.</text> </paragraph> <paragraph num="(4)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(5)"> <text>“Data extract” means a subset of information from the Maryland medical care database or other data base maintained by the Commission based on criteria provided by an applicant.</text> </paragraph> <paragraph num="(6)"> <text>“Data recipient” means a person, governmental entity, or other entity whose application has been approved and who is authorized to access and use data requested in an application in accordance with a data use agreement.</text> </paragraph> <paragraph num="(7)"> <text>“Data release” means the process of providing a data recipient with access and use of data requested in an application in accordance with a data use agreement.</text> </paragraph> <paragraph num="(8)"> <text>“Data Release Advisory Committee” or “DRAC” means a multi-stakeholder group of individuals appointed by the Commission whose functions include but are not limited to that of privacy board review as described in 45 CFR §164.512, reviewing completed applications, and making a written recommendation to the Executive Director regarding whether an application should be approved, approved with conditions, or disapproved.</text> </paragraph> <paragraph num="(9)"> <text>“Data set” means a collection of separate data elements or variables that can be manipulated as a unit.</text> </paragraph> <paragraph num="(10)"> <text>“Data use agreement” means a written contractual document entered into between the Commission and a data recipient that contains terms and conditions that govern a data recipient’s access to and use of data provided by the Commission.</text> </paragraph> <paragraph num="(11)"> <text>“De-identified data” means information that does not identify an individual and for which there is no reasonable basis to believe that it can be used to identify an individual.</text> </paragraph> <paragraph num="(12)"> <text>“Direct individual identifier” means personal information such as name, Social Security number, and date of birth that uniquely identifies an individual or that can be combined with other readily available information to uniquely identify an individual.</text> </paragraph> <paragraph num="(13)"> <text>“Disclose” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of data release pursuant to this chapter.</text> </paragraph> <paragraph num="(14)"> <text>Entity.</text> <paragraph num="(a)"> <text>“Entity” means a person, partnership, firm, association, limited liability company, limited liability partnership, or public or private corporation.</text> </paragraph> <paragraph num="(b)"> <text>“Entity includes a county or municipality of Maryland or a governmental entity of another state.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Executive Director” means the Executive Director of the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(16)"> <text>“Funding source” means any federal or state governmental entity, public or private corporation or organization, educational or research institution or organization, foundation, person, individual, or other entity that has committed to give or grant, or has already given or granted, monetary funds to an applicant to cover all or part of the costs of the proposed use of the data described in an application submitted to the Commission.</text> </paragraph> <paragraph num="(17)"> <text>Governmental Entity.</text> <paragraph num="(a)"> <text>“Governmental entity” means any agency, authority, board, commission, council, department, instrumentality, unit, or other body of State government or the federal government that is established by law.</text> </paragraph> <paragraph num="(b)"> <text>“Governmental entity” does not include a county or municipality of Maryland or a governmental entity of another state.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“HIPAA” means the United States Health Insurance Portability and Accountability Act of 1996, P.L.10491, as implemented and amended in federal regulations, including the HIPAA Privacy and Security Rules, 45 CFR Parts 160 and 164, as they may be amended, modified, or renumbered, including as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act.</text> </paragraph> <paragraph num="(19)"> <text>“Identifiable data” means information that contains data elements that can be used to identify a specific individual.</text> </paragraph> <paragraph num="(20)"> <text>“Indirect individual identifier” means a data element that can be used to identify an individual when combined with other information or data.</text> </paragraph> <paragraph num="(21)"> <text>“Institutional Review Board” or “IRB” has the meaning stated in 45 CFR Part 46, and any subsequent revisions of those regulations, as they may be amended, modified, or renumbered, regarding the protection of human subject research.</text> </paragraph> <paragraph num="(22)"> <text>“Medicaid” means the Maryland Medical Assistance Program.</text> </paragraph> <paragraph num="(23)"> <text>“Medical Care Data Base” or “MCDB” means the data base established and maintained by the Commission pursuant to Health-General Article, §19-133, Annotated Code of Maryland, that collects eligibility data, professional services claims, institutional services claims, pharmacy claims, and provider data for Maryland residents enrolled in private insurance, Medicaid, or Medicare. The MCDB is Maryland’s all-payer claims data base.</text> </paragraph> <paragraph num="(24)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, representative of any kind, partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(25)"> <text>“Product” means any creation derived in whole or part from data released pursuant to this chapter, including an analysis, article, chart, compilation, display, finding, graph, information, manuscript, map, presentation, publication, report, service, software, study, subscription service, summary, table, or website.</text> </paragraph> <paragraph num="(26)"> <text>“Protected health information” or “PHI” means individually identifiable health information as defined in the HIPAA Privacy Rule at 45 CFR §160.103, as it may be amended, modified, or renumbered.</text> </paragraph> <paragraph num="(27)"> <text>“State” means:</text> <paragraph num="(a)"> <text>When capitalized, the State of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>When lowercase, any state, possession, territory, or commonwealth of the United States, or the District of Columbia.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Types of Data Available for Release."> <paragraph num="A."> <text>The types of data specified in §C of this regulation may be released to an applicant whose application has been approved in accordance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The availability of the types of data specified in §C of this regulation requesting Medicaid data are subject to a determination of availability by Medicaid.</text> </paragraph> <paragraph num="C."> <text>Data may be provided pursuant to an approved application at the following levels of detail:</text> <paragraph num="(1)"> <text>De-identified standard analytic file: A data extract that contains only data elements that are not considered PHI because the extract excludes direct and indirect individual identifiers as defined in the HIPAA Privacy Rule.</text> </paragraph> <paragraph num="(2)"> <text>Limited data set: A data extract that contains a limited set of indirect individual identifiers as defined in the HIPAA Privacy Rule and excludes direct individual identifiers.</text> </paragraph> <paragraph num="(3)"> <text>Custom data file: A data extract that is created based on criteria provided by an applicant and deemed the minimum amount necessary for an applicant’s proposed use of the data and consists of:</text> <paragraph num="(a)"> <text>Indirect individual identifiers that can be used to identify individuals when combined with other information or data; or</text> </paragraph> <paragraph num="(b)"> <text>Aggregate, summary data in which the risk of identifying individuals is minimal.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requests for Medicaid Data."> <paragraph num="A."> <text>An application submitted to the Commission that includes a request for Medicaid data shall be referred to Medicaid for review after Commission staff has reviewed the application and determined the application to be complete in accordance with Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Medicaid shall review an application referred pursuant to §A of this regulation and notify Commission staff in writing within 15 business days of the date of referral of Medicaid’s decision to:</text> <paragraph num="(1)"> <text>Proceed with its own independent application review and decision-making process on that part of an application requesting Medicaid data:</text> <paragraph num="(a)"> <text>Without further involvement or participation of Commission staff, the DRAC, or the full Commission; and</text> </paragraph> <paragraph num="(b)"> <text>That is not governed by the review and decision-making process in Regulations .07—.14 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Decline to proceed with its own independent application review and decision-making process as described in §B(1) of this regulation and direct Commission staff to proceed with processing the referred application in accordance with Regulations .07—.11 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Disapprove the request for Medicaid data based on the information provided in an application, in which case Medicaid shall provide reasons for the disapproval in the written notification to Commission staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If Commission staff does not receive written notification from Medicaid within 15 business days of referring an application to Medicaid pursuant to §§A and B of this regulation, Commission staff shall proceed with processing the application in accordance with Regulations .07—.11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requests for Data from Governmental Entities."> <paragraph num="A."> <text>A governmental entity requesting data shall submit a written data request in the form and manner specified by the Commission that shall:</text> <paragraph num="(1)"> <text>Be signed by the agency head or chief executive officer of a governmental entity; and</text> </paragraph> <paragraph num="(2)"> <text>Include a signed statement by a governmental entity’s legal counsel that the governmental entity has legal authority to use the requested data for the purpose described in the written data request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The written data request submitted in accordance with §A of this regulation shall include at a minimum:</text> <paragraph num="(1)"> <text>A description of the proposed purpose and use of the data requested and, if applicable, a description of an intention to incorporate the data requested into a product;</text> </paragraph> <paragraph num="(2)"> <text>A description of, and reasons for, any proposed linkages to other data;</text> </paragraph> <paragraph num="(3)"> <text>A data management plan that demonstrates appropriate privacy and security controls for access and storage of the data and for protection against inadvertent and unauthorized access and disclosure of the data; and</text> </paragraph> <paragraph num="(4)"> <text>The safeguards against re-identification of an individual in a product that will be created or published publicly by the governmental entity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Executive Director may make a final decision on whether to approve, approve with conditions, or disapprove a governmental entity’s data request provided that, prior to making a final decision, the Executive Director considers each of the criteria for approval and each reason for disapproval described in §E of this regulation.</text> </paragraph> <paragraph num="D."> <text>The Executive Director may exercise the discretion not to make a final decision on a governmental entity’s request for data and refer the data request to the DRAC for review and a written recommendation in accordance with Regulation .09 of this chapter. Upon receipt of a written report and recommendation from the DRAC, the Executive Director may, in the Executive Director’s discretion, either:</text> <paragraph num="(1)"> <text>Make a final decision in accordance with Regulation .10A—C of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Refer the DRAC’s report and recommendation to a panel of three Commission members or the full Commission in accordance with Regulation .10D—E of this chapter for a decision on the data request.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In reviewing and making a recommendation or final decision on whether a data request shall be approved, approved with conditions, or disapproved, the Executive Director, the DRAC, a panel of three Commission members, or the full Commission, as applicable, shall determine whether the proposed use of the data requested:</text> <paragraph num="(1)"> <text>Falls within the public interest uses described in Regulation .01B of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Meets the applicable criteria for approval in Regulation .09C of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Should be disapproved for any of the reasons in Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Prior to the receipt of data pursuant to an approved data request, a governmental entity shall enter into a written data use agreement with the Commission in accordance with Regulation .13 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Requests for Data from Nongovernmental Entities."> <paragraph num="A."> <text>Submission of Applications.</text> <paragraph num="(1)"> <text>An applicant shall complete and submit a written application in the form and manner specified by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>An applicant shall disclose on an application all potential or approved funding sources at the time of submission of an application.</text> </paragraph> <paragraph num="(3)"> <text>If applicable, an applicant shall disclose any data sharing or other requirements imposed by a funding source as a condition of receipt of funding.</text> </paragraph> <paragraph num="(4)"> <text>An applicant shall disclose on an application whether an applicant or any person or entity that is an officer, owner, operator, or part of management of an applicant’s organization who will have access and use of the requested data is currently, or has been within 10 years prior to the date of the application, a subject of or a party to a state or federal regulatory agency action or civil or criminal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being:</text> <paragraph num="(a)"> <text>Convicted of a felony or pleading guilty, nolo contendere, entering a best interest plea of guilty, or receiving a diversionary disposition regarding a felony;</text> </paragraph> <paragraph num="(b)"> <text>A subject of an investigation conducted by, or a pending complaint, charge, or indictment issued by, a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or</text> </paragraph> <paragraph num="(c)"> <text>A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A person who signs an application shall:</text> <paragraph num="(a)"> <text>Be an officer of an applicant’s organization who has been given signatory authority to bind the organization, unless an applicant is not part of an organization and is requesting data in an applicant’s individual capacity, in which case the applicant shall sign an application; and</text> </paragraph> <paragraph num="(b)"> <text>Sign the following affirmation statement: “I solemnly affirm under the penalties of perjury that the contents of the application and any supplementary information are true to the best of my knowledge, information, and belief.”</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An applicant shall pay a nonrefundable application fee in the amount specified in the list of fees published on the Commission’s website at the time of submission of an application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Completeness Review.</text> <paragraph num="(1)"> <text>An application is not complete until an applicant has submitted a completed application, as determined by Commission staff, and provided any additional information, documentation, answers to questions, and clarifications requested by Commission staff within the time limit specified by Commission staff.</text> </paragraph> <paragraph num="(2)"> <text>After Commission staff has determined that an application is complete, Commission staff shall refer an application requesting Medicaid data to Medicaid for review in accordance with Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>If Commission staff has received a written response from Medicaid specifying its decision on whether to proceed on the request for Medicaid data under either Regulation .04B(1), (2) or (3) of this chapter, Commission staff shall refer a completed application, Medicaid’s written response, all supporting documentation, and any public comment received under Regulation .07 of this chapter, to the DRAC for further review in accordance with Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>In accordance with Regulation .04C of this chapter, if Commission staff has not received a written response from Medicaid within 15 business days of Commission staff’s referral of the application to Medicaid, then Commission staff shall proceed with processing the application, including the request for Medicaid data, in accordance with Regulations .07—.11 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>If Medicaid disapproves the part of an application requesting Medicaid data pursuant to Regulation .04B(3) of this chapter, an applicant shall notify Commission staff in writing within 15 business days of an applicant’s wishes regarding further consideration of a non-Medicaid part of an application, specifically, whether an applicant requests that:</text> <paragraph num="(a)"> <text>Commission staff refer the part of a completed application requesting non-Medicaid data to the DRAC for further review in accordance with Regulation .09 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>An applicant’s entire application be withdrawn and receive no further consideration, in which case Commission staff shall administratively close the application pursuant to §B(7) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If an applicant fails to notify Commission staff in writing within 15 business days of receiving notice that Medicaid has disapproved the Medicaid part of an application as required under §B(5) of this regulation, Commission staff may administratively close an application pursuant to §B(7) of this regulation.</text> </paragraph> <paragraph num="(7)"> <text>An application may be administratively closed and receive no further consideration if:</text> <paragraph num="(a)"> <text>An applicant fails to provide a complete application, in the judgment of Commission staff, including providing all additional information, documentation, answers to questions, and clarifications requested by Commission staff, or by the DRAC during its review of an application under Regulation .09 of this chapter, within the time limit specified by Commission staff or the DRAC; or</text> </paragraph> <paragraph num="(b)"> <text>An applicant fails to provide the written notification within 15 business days as required under §B(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>For an applicant to receive further consideration of a request for data in an application that was administratively closed under §B(7) of this regulation, an applicant shall file a new application and pay the required fees that are in effect at the time of submission of a new application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Transparency of Data Request and Data Release Process."> <paragraph num="A."> <text>Except for applications submitted by governmental entities pursuant to an express state or federal statutory or regulatory mandate, all completed applications shall be published on the Commission’s website during the pendency of the review process, without those parts of the application that specify an applicant’s proposed data management plan and security measures.</text> </paragraph> <paragraph num="B."> <text>Members of the public may submit written comment on an application for a period of 10 business days following the date on which an application is published on the Commission’s website.</text> </paragraph> <paragraph num="C."> <text>Commission staff shall provide all public comments received on an application to the DRAC for review and consideration in accordance with Regulation .09 of this chapter.</text> </paragraph> <paragraph num="D."> <text>After a decision has been made on an application, the following information shall be published on the Commission’s website:</text> <paragraph num="(1)"> <text>The disposition of an application; that is, whether the application has been:</text> <paragraph num="(a)"> <text>Approved;</text> </paragraph> <paragraph num="(b)"> <text>Approved with conditions;</text> </paragraph> <paragraph num="(c)"> <text>Disapproved; or</text> </paragraph> <paragraph num="(d)"> <text>Withdrawn;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For approved applications:</text> <paragraph num="(a)"> <text>The amount of fees charged for requested data;</text> </paragraph> <paragraph num="(b)"> <text>A statement that all fees were waived; or</text> </paragraph> <paragraph num="(c)"> <text>In the case of a partial waiver of fees, the amount of fees waived;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If applicable, notice that further review of a decision on the application is pending under Regulation .11 of this chapter and a description of the final decision when the further review process is completed; and</text> </paragraph> <paragraph num="(4)"> <text>A summary description of a product derived in whole or part from data released to an applicant pursuant to this chapter, subject to any prohibition on public disclosure under applicable federal or State law, including the Maryland Public Information Act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Data Release Advisory Committee."> <paragraph num="A."> <text>The Commission shall establish a Data Release Advisory Committee (DRAC) that meets the membership composition requirements and performs the review functions of a privacy board as described in 45 CFR §164.512.</text> </paragraph> <paragraph num="B."> <text>The Commission shall appoint the members of the DRAC and a chairperson from among the appointed members.</text> </paragraph> <paragraph num="C."> <text>The number of members appointed to the DRAC shall be at the discretion of the Commission but large enough to:</text> <paragraph num="(1)"> <text>Represent the appropriate range of stakeholder groups described in §D of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Provide relevant experience, professional competency, and subject matter expertise in the areas of consumer privacy and advocacy, data analytics, data privacy, data security, health policy research, individual privacy issues, information technology, public health, and the use and analysis of health care claims data.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The membership of the DRAC shall include, but not be limited to:</text> <paragraph num="(1)"> <text>Representatives of various stakeholder groups, including academic research organizations, consumer advocacy organizations, employers, health care providers, health maintenance organizations, insurers, and nonprofit health service plans, that possess the relevant experience, professional competency, and subject matter expertise described in §C(2) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>At least one representative from Medicaid;</text> </paragraph> <paragraph num="(3)"> <text>At least one Commission staff member who shall serve as an ex-officio member; and</text> </paragraph> <paragraph num="(4)"> <text>Any additional representatives that the Commission determines are needed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Members of the DRAC shall serve for a term not to exceed 3 years. At the end of a term, a member continues to serve until a successor is appointed. A member of the DRAC may be reappointed.</text> </paragraph> <paragraph num="F."> <text>The DRAC shall meet as necessary to:</text> <paragraph num="(1)"> <text>Review completed applications requesting data;</text> </paragraph> <paragraph num="(2)"> <text>Prepare reports and recommendations, with the administrative support of Commission staff, and submit them to the Executive Director;</text> </paragraph> <paragraph num="(3)"> <text>If requested by Commission staff or the Executive Director, provide advice, consultation, and expertise on issues and questions that may arise:</text> <paragraph num="(a)"> <text>During Commission staff’s review of applications under Regulations .05 and .06 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>During the Executive Director’s review of applications under Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>After an application has been approved and requested data has been released to a data recipient, regarding compliance and enforcement of a data use agreement under Regulations .13 and .14 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Perform any other duties and obligations required of the DRAC under this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Commission staff shall provide the necessary administrative support required for the DRAC to perform its duties and obligations under this chapter, such as facilitating the scheduling and conducting of DRAC meetings, providing DRAC meeting agendas and supporting reference materials, conducting research and obtaining additional information as requested by the DRAC, and assisting in the preparation of written reports and recommendations.</text> </paragraph> <paragraph num="H."> <text>The Executive Director may remove a member of the DRAC for neglect of duty or misconduct by providing written notification to the DRAC member, stating the reason for the removal.</text> </paragraph> <paragraph num="I."> <text>A member of the DRAC who receives written notification of removal under §H of this regulation may submit a written request for full Commission review of the Executive Director’s removal decision within 20 business days of the date of the Executive Director’s written notification of removal. The written request for full Commission review shall state with particularity the grounds and factual basis for the DRAC member’s disagreement with the Executive Director’s decision to remove the DRAC member.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Data Release Advisory Committee Review."> <paragraph num="A."> <text>The following data requests are not subject to review by the DRAC:</text> <paragraph num="(1)"> <text>Those categories of data requests and data release described in Regulation .01D(1)—(5) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Requests for data submitted by a governmental entity that the Executive Director determines warrants an expedited review under Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Requests for aggregate, summarized data as described in Regulation .03C(3)(b) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In reviewing an application, the DRAC shall consider the criteria for approval and reasons for disapproval of an application in §§C and D of this regulation and all public comment received under Regulation .07 of this chapter before preparing a written report and recommendation.</text> </paragraph> <paragraph num="C."> <text>The DRAC shall determine whether an application has met the following criteria for approval:</text> <paragraph num="(1)"> <text>An applicant has provided documentation of relevant education, training, and experience that demonstrates the applicant is capable of undertaking and accomplishing the objective of the proposed use of the data and being a responsible steward of the requested data.</text> </paragraph> <paragraph num="(2)"> <text>The data elements requested by an applicant are the minimum amount necessary to achieve the intended purpose for which the data is requested.</text> </paragraph> <paragraph num="(3)"> <text>The proposed use of the data complies with applicable State and federal laws, including those laws relating to the privacy and security of protected health information (PHI).</text> </paragraph> <paragraph num="(4)"> <text>The applicant has provided a written data management plan that demonstrates appropriate privacy and security controls for access and storage of the data and for safeguarding individual privacy and preventing unauthorized access and use of the data.</text> </paragraph> <paragraph num="(5)"> <text>The requirement of obtaining written authorization from each individual who is the subject of requested identifiable data can be waived in accordance with 45 CFR §164.512.</text> </paragraph> <paragraph num="(6)"> <text>If the applicant has proposed linkage of the requested data to other data source(s), the applicant has provided:</text> <paragraph num="(a)"> <text>Sufficient written justification of the need to link the requested data to the other data source(s) named in the application to accomplish the objective and achieve the results of the proposed use of the data; and</text> </paragraph> <paragraph num="(b)"> <text>Written proof that an additional level of data privacy and security controls will be in place to protect the privacy and identification of the individuals who are the subject of the requested data and the other data source(s) to which the requested data is to be linked.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>An applicant who proposes to develop and sell a product that contains de-identified data has provided satisfactory written justification of how the proposed sale of the product using the de-identified data will serve the public interest.</text> </paragraph> <paragraph num="(8)"> <text>The proposed use of the data is in the public interest. Examples of uses of data that serve the public interest include:</text> <paragraph num="(a)"> <text>Health care cost and utilization analysis to guide and develop public policy;</text> </paragraph> <paragraph num="(b)"> <text>Studies that promote improvement in public health, health care quality, and health care access;</text> </paragraph> <paragraph num="(c)"> <text>Health planning and resource allocation studies;</text> </paragraph> <paragraph num="(d)"> <text>Making information on cost and quality accessible to the public; and</text> </paragraph> <paragraph num="(e)"> <text>Studies directly tied to evaluation and improvement of federal and State government initiatives.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The DRAC shall determine whether an application has met any of the following criteria for disapproval:</text> <paragraph num="(1)"> <text>The proposed use of the data violates State or federal law.</text> </paragraph> <paragraph num="(2)"> <text>The proposed use of the data is not in the public interest.</text> </paragraph> <paragraph num="(3)"> <text>The proposed use of the data is designed so that the stated objective of the project cannot be met.</text> </paragraph> <paragraph num="(4)"> <text>False information or documentation on, or related to, an application was provided to Commission staff, the DRAC, the Executive Director, or the Commission.</text> </paragraph> <paragraph num="(5)"> <text>An applicant provided incomplete information upon which to base a decision on the application.</text> </paragraph> <paragraph num="(6)"> <text>An applicant or any person or entity that is an officer, owner, operator, or part of management of an applicant’s organization who will have access and use of the requested data is currently, or has been within 10 years prior to the date of the application, a subject of or a party to a state or federal regulatory agency action or civil or criminal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being:</text> <paragraph num="(a)"> <text>Convicted of a felony or pleading guilty, nolo contendere, entering a best interest plea of guilty, or receiving a diversionary disposition regarding a felony;</text> </paragraph> <paragraph num="(b)"> <text>A subject of an investigation conducted by, or a pending complaint, charges, or indictment issued by a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or</text> </paragraph> <paragraph num="(c)"> <text>A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Violation of a previous data use agreement.</text> </paragraph> <paragraph num="(8)"> <text>The data management plan does not demonstrate privacy and security controls for safeguarding individual privacy and preventing unauthorized access to or use of the data.</text> </paragraph> <paragraph num="(9)"> <text>The proposed use of the data is for an impermissible purpose, which includes but is not limited to:</text> <paragraph num="(a)"> <text>Using the requested data to identify an individual using a particular product or drug in order to develop a marketing campaign and directly contact an individual;</text> </paragraph> <paragraph num="(b)"> <text>Using the requested data to contact an individual for fund-raising purposes directly; and</text> </paragraph> <paragraph num="(c)"> <text>Using the requested data to contact an individual who is the subject of the data for any reason.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>An applicant who proposes to develop and sell a product that contains requested de-identified data has not provided satisfactory written justification of how the proposed sale of the product using the de-identified data will serve the public interest.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A member of the DRAC who has an affiliation with an applicant, or with any entity sponsoring, participating, or otherwise affiliated with an applicant’s proposed use of the requested data or any other conflict of interest or appearance of impropriety, shall recuse from consideration of that applicant’s application and may not participate in any discussions with other DRAC members or vote on the application.</text> </paragraph> <paragraph num="F."> <text>The DRAC may request that the Executive Director authorize the DRAC to invite an individual with expertise and competence in certain areas to assist the DRAC in the review of complex issues that require expertise beyond, or in addition to, that available among the membership of the DRAC. An individual invited pursuant to this section may not:</text> <paragraph num="(1)"> <text>Have an affiliation with an applicant, or with any entity sponsoring, participating in, or otherwise affiliated with an applicant’s proposed use of the requested data or any other conflict of interest or appearance of impropriety; and</text> </paragraph> <paragraph num="(2)"> <text>Vote on an application.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The DRAC may require an applicant to obtain Institutional Review Board review prior to deciding on a recommendation for an application.</text> </paragraph> <paragraph num="H."> <text>The DRAC may request that Commission staff obtain additional information and documentation from an applicant if needed to determine whether the criteria for approval in §C of this regulation have been met or the reasons for disapproval in §D of this regulation exist. If an applicant does not provide the additional information within the time limit specified by the DRAC, the DRAC may refer the application to Commission staff with a request that the application submitted by the applicant be administratively closed per Regulation .06B(7) of this chapter.</text> </paragraph> <paragraph num="I."> <text>The DRAC, at its discretion, may require that an applicant meet with the DRAC to provide additional information, answer questions, or provide clarification on information provided in an application, the proposed use of the data requested, or the capability of an applicant to accomplish the objective of the proposed use of requested data.</text> </paragraph> <paragraph num="J."> <text>The DRAC shall review and consider all public comment received regarding an application under Regulation .07 of this chapter before making a recommendation to the Executive Director.</text> </paragraph> <paragraph num="K."> <text>The DRAC, with the administrative support of Commission staff, shall prepare a written report and recommendation for the Executive Director on each application reviewed, which shall address:</text> <paragraph num="(1)"> <text>Each of the approval criteria in §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Each of the disapproval criteria in §D of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Any public comment received; and</text> </paragraph> <paragraph num="(4)"> <text>The DRAC’s recommendation on whether an application should be approved, approved with conditions, or disapproved.</text> </paragraph> </paragraph> <paragraph num="L."> <text>After an application is approved pursuant to Regulation .10 of this chapter, Commission staff may:</text> <paragraph num="(1)"> <text>Seek the advice and expertise of the DRAC on any issues regarding the applicant’s receipt of data or compliance with the terms and conditions of a data use agreement entered into under Regulation .13 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Request that the DRAC prepare a written report and recommendation to the Executive Director regarding whether any compliance and enforcement actions may be warranted under Regulation .14 of this chapter.</text> </paragraph> </paragraph> <paragraph num="M."> <text>A DRAC recommendation on an application or on other issues related to an applicant’s receipt of data or compliance with the terms and conditions of a data use agreement entered into under Regulation .13 of this chapter is advisory and not binding on the Executive Director’s decision on an application or on whether to pursue an enforcement action under Regulation .14 of this chapter for noncompliance with a data use agreement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Executive Director Review and Decision on Requests for Data."> <paragraph num="A."> <text>Before making a decision on an application requesting data, the Executive Director shall:</text> <paragraph num="(1)"> <text>Review and consider the DRAC’s written report and recommendation;</text> </paragraph> <paragraph num="(2)"> <text>Review all public comment received;</text> </paragraph> <paragraph num="(3)"> <text>Determine whether the approval criteria set forth in Regulation .09C of this chapter have been met; and</text> </paragraph> <paragraph num="(4)"> <text>Determine whether any of the disapproval criteria set forth in Regulation .09C of this chapter exists for disapproval of an application under Regulation .09D of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Executive Director determines that there is insufficient information upon which to base a decision on an application, the Executive Director may refer an application back to the DRAC with a request that the DRAC, through Commission staff, obtain and provide more specific or additional information, conduct a more detailed review and evaluation of the review criteria, and, if appropriate, submit a revised written report and recommendation.</text> </paragraph> <paragraph num="C."> <text>After considering the DRAC’s written report and recommendation on an application, the Executive Director shall issue a written decision:</text> <paragraph num="(1)"> <text>Approving an application;</text> </paragraph> <paragraph num="(2)"> <text>Approving an application subject to conditions, which shall be included as conditions in the data use agreement required under Regulation .13 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Disapproving an application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Executive Director decides not to adopt the DRAC’s recommendation, specifically to approve an application that the DRAC has recommended be disapproved, or to disapprove an application that the DRAC has recommended be approved, then the Executive Director shall prepare a proposed recommended decision and refer to the full Commission for consideration and issuance of a final decision affirming, reversing, or modifying the Executive Director’s recommended decision.</text> </paragraph> <paragraph num="E."> <text>The Executive Director may exercise the discretion not to make a decision on an application and refer the DRAC’s written report and recommendation, and all public comment received on an application, to a review panel of 3 Commission members, which shall include a consumer member of the Commission. A review panel may render a final written decision on the application, or elect not to make a decision and refer the application to the full Commission for a decision.</text> </paragraph> <paragraph num="F."> <text>The Executive Director may not make a decision on an application that proposes to develop and sell a product that contains requested de-identified data and shall refer the application, the DRAC’s written report and recommendation, and all public comment received on the application to the full Commission for a decision.</text> </paragraph> <paragraph num="G."> <text>The Executive Director, a review panel, or the full Commission, as applicable, shall issue a written decision notifying an applicant that an application has been approved, approved with conditions, or disapproved. The written decision shall state the conditions imposed, if any, and, if an application is disapproved, state the reasons for disapproval.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Review of Decisions on Requests for Data."> <paragraph num="A."> <text>Request for Further Review of Decisions on Requests for Data.</text> <paragraph num="(1)"> <text>An applicant may submit a written request for full Commission review of a written decision issued by the Executive Director or a review panel, as applicable, under Regulation .10G of this chapter, within 20 business days of the date the written decision is issued, which shall:</text> <paragraph num="(a)"> <text>State with particularity the grounds and factual basis for an applicant’s disagreement with the decision and include citations to specific documentation or authority for each argument made in support of an applicant’s disagreement with the decision;</text> </paragraph> <paragraph num="(b)"> <text>Include all relevant supporting documentation and authority cited in §A(1)(a) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Specify the remedy requested:</text> <paragraph num="(i)"> <text>Reversal of the decision and unconditional release of the requested data; or</text> </paragraph> <paragraph num="(ii)"> <text>Modification of the decision to release the requested data subject to conditions; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If desired, include a written request to present oral argument to the full Commission, which shall be scheduled if requested.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After reviewing and considering an applicant’s written request for review of a decision and any oral argument, if applicable, the full Commission shall issue a written decision affirming, reversing, or modifying the decision reviewed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Request for Reconsideration of Commission Decisions on Requests for Data.</text> <paragraph num="(1)"> <text>If the full Commission, instead of the Executive Director or a review panel, issues a decision on an application, an applicant may submit, within 20 business days of the date the Commission’s written decision was issued, a written request, which shall conform to §A(1) of this regulation, that the Commission reconsider its decision.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall review and consider an applicant’s written request for reconsideration of its previous decision and any oral argument, if requested, and issue a written decision affirming, reversing, or modifying its previous decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Fees."> <paragraph num="A."> <text>The Commission may charge fees to an applicant and data recipient for:</text> <paragraph num="(1)"> <text>Submission of an application; and</text> </paragraph> <paragraph num="(2)"> <text>The cost of accessing data, which may include but is not limited to the costs of producing and releasing data to a data recipient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A list of fees to be charged pursuant to §A of this regulation shall be published on the Commission’s website, reviewed annually, and updated as needed.</text> </paragraph> <paragraph num="C."> <text>A list of proposed fees shall be published on the Commission’s website for receipt of written public comment for a period of 30 days before the proposed fees become final. All public comment received shall be considered before the proposed fees become final.</text> </paragraph> <paragraph num="D."> <text>An applicant shall pay the required application fee in full before Commission staff may begin the application review process. An application fee paid by an applicant is nonrefundable.</text> </paragraph> <paragraph num="E."> <text>An applicant who is approved to receive requested data shall pay all required fees in full prior to receipt of requested data. Fees paid by an approved data recipient for receipt of requested data are nonrefundable.</text> </paragraph> <paragraph num="F."> <text>If an approved applicant does not pay the required fees in full within 30 days of the date of written notification of application approval, the applicant will not receive the requested data and the application shall be deemed withdrawn and will receive no further consideration.</text> </paragraph> <paragraph num="G."> <text>The Executive Director may grant a partial or full waiver of fees for requested data if:</text> <paragraph num="(1)"> <text>An applicant submits a written request for partial or full waiver of fees detailing reasons for the waiver request and, if applicable, state the amount of partial waiver requested;</text> </paragraph> <paragraph num="(2)"> <text>An applicant provides financial statements or any other supporting documentation requested by the Executive Director regarding the applicant’s inability to pay required fees;</text> </paragraph> <paragraph num="(3)"> <text>An applicant is a recipient of monetary funds from a funding source that covers all or part of the costs of an applicant’s use of the data, and the applicant provides documentation of:</text> <paragraph num="(a)"> <text>An applicant’s written proposal requesting funding submitted to a funding source;</text> </paragraph> <paragraph num="(b)"> <text>A funding source’s response to an applicant’s request for funding and, if applicable, funding approval;</text> </paragraph> <paragraph num="(c)"> <text>Any requirements, including data sharing, imposed by a funding source as a condition of receipt of funding;</text> </paragraph> <paragraph num="(d)"> <text>The budget governing an applicant’s use and allocation of the monetary funds that a funding source has granted or given to an applicant; and</text> </paragraph> <paragraph num="(e)"> <text>Any other documentation regarding a funding source requested by the Executive Director;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant timely provides any other information and documentation requested by the Executive Director; and</text> </paragraph> <paragraph num="(5)"> <text>After considering all information provided by an applicant in support of a full or partial fee waiver, the Executive Director determines that a full or partial waiver of fees is in the public interest.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Before making a final decision on a request for a partial or full waiver of fees under §G of this regulation, the Executive Director may consult with a review panel or the full Commission if the Executive Director deems it appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Data Use Agreement."> <paragraph num="A."> <text>An approved applicant shall enter into and sign a data use agreement prior to receipt of the requested data. If an approved applicant does not sign a data use agreement within 30 days of the date of written notification of application approval, the application shall be deemed withdrawn and will receive no further consideration.</text> </paragraph> <paragraph num="B."> <text>Prior to entry into a data use agreement and receipt of requested data, an approved applicant shall disclose any data sharing plan or agreement required by a funding source as a condition of an applicant’s receipt of funding.</text> </paragraph> <paragraph num="C."> <text>A data use agreement entered into with a data recipient under §A of this regulation shall, at a minimum:</text> <paragraph num="(1)"> <text>Define the scope of use of the requested data and the research methodology;</text> </paragraph> <paragraph num="(2)"> <text>Provide a plan for safeguarding the privacy and security of the data and complying with all applicable laws governing the privacy and security of data;</text> </paragraph> <paragraph num="(3)"> <text>Require a data recipient to adhere to security processes and procedures aimed at preventing unauthorized access, use, or disclosure of the data;</text> </paragraph> <paragraph num="(4)"> <text>Require that a data recipient notify Commission staff of any potential or actual data breach, including any instance of unauthorized access, use, or disclosure of data, no later than 7 days from the date of knowledge of the breach;</text> </paragraph> <paragraph num="(5)"> <text>Require a data recipient to notify Commission staff in writing within 24 hours of receipt of any request from a third party requesting a data recipient to disclose all or part of the data received from the Commission, including but not limited to compulsory process, such as a subpoena, discovery request, warrant, or judicial or administrative order, or a public information act request, to provide the Commission adequate time to intervene and respond before the date that a data recipient has been requested or ordered to provide the data;</text> </paragraph> <paragraph num="(6)"> <text>Specify the beginning and end dates of a data use agreement;</text> </paragraph> <paragraph num="(7)"> <text>Provide for the return or destruction of data by a certain date upon termination of a data use agreement, or upon a determination that a data recipient has failed to comply with a data use agreement;</text> </paragraph> <paragraph num="(8)"> <text>Require that a data recipient comply and assist, if requested, in any audit of compliance with a data use agreement;</text> </paragraph> <paragraph num="(9)"> <text>Provide that a breach of any term or condition of a data use agreement is a breach of contract;</text> </paragraph> <paragraph num="(10)"> <text>Permit that appropriate administrative and judicial remedies under applicable law may be pursued against a data recipient for failing to comply with the terms and conditions of a data use agreement; and</text> </paragraph> <paragraph num="(11)"> <text>Be signed by:</text> <paragraph num="(a)"> <text>A person authorized to contractually bind a data recipient’s organization; or</text> </paragraph> <paragraph num="(b)"> <text>A data recipient, if a data recipient is not part of an organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Executive Director may consider a request from a data recipient for an extension of time or a modification of a term or condition of an executed data use agreement if:</text> <paragraph num="(1)"> <text>A data use agreement includes an express provision allowing a request for an extension of time or a modification of a term or condition;</text> </paragraph> <paragraph num="(2)"> <text>A data recipient submits a written request in the form and manner specified by the Commission, which shall include the reasons for the request, or specify good cause for the extension or modification request;</text> </paragraph> <paragraph num="(3)"> <text>A request for an extension of time states the requested new end date for the data use agreement; and</text> </paragraph> <paragraph num="(4)"> <text>A request for modification does not seek approval of a new or different use of the released data that was not approved under Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Commission staff shall refer a written request for an extension of time or a modification of a term or condition of a data use agreement to the Executive Director for a decision. The Executive Director shall:</text> <paragraph num="(1)"> <text>Consider a data recipient’s written request submitted under §D of this regulation before making a decision; and</text> </paragraph> <paragraph num="(2)"> <text>Make a decision to approve, approve with conditions, or disapprove the request, and notify the data recipient in writing of the decision.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the Executive Director approves an extension or modification request, or approves with conditions, the Executive Director shall issue a signed, dated written amendment to the data use agreement approving the extension or modification request, stating the new end date of the data use agreement, if applicable, and specifying any additional conditions on the extension or modification.</text> </paragraph> <paragraph num="G."> <text>Re-Use of Data.</text> <paragraph num="(1)"> <text>A data recipient who wishes to re-use data previously released, pursuant to an approved application and executed data use agreement prior to the termination of the data use agreement and destruction of the data, for a different use or purpose or to link with other data sources not described in the approved application shall submit a written application in the form and manner specified by the Commission and pay a nonrefundable application fee in the amount published on the Commission’s website at the time of submission of an application for re-use of previously released data.</text> </paragraph> <paragraph num="(2)"> <text>Commission staff shall refer a data recipient’s completed application for re-use of previously released data prior to termination of a data use agreement for a different use for DRAC and Executive Director review, in accordance with Regulations .09—.11 of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>If a re-use application is approved, a data recipient shall pay the applicable nonrefundable data re-use fees in full in the amount published on the Commission’s website before a data recipient can use the previously released data for a different use or purpose.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A data recipient who wishes to request additional data not requested in a data recipient’s approved application and described in a data use agreement shall:</text> <paragraph num="(1)"> <text>Submit a new application in the form and manner specified by the Commission and pay a new nonrefundable application fee in accordance with Regulation .12 of this chapter, regardless of whether a data recipient intends to use the additional data for the same use described in a data recipient’s previously approved application; and</text> </paragraph> <paragraph num="(2)"> <text>Pay required fees for receipt of additional data in accordance with Regulation .12 of this chapter if a data recipient’s request for additional data is approved.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Compliance and Enforcement."> <paragraph num="A."> <text>If a data recipient fails to comply with any of the terms and conditions of a data use agreement, or it becomes known after execution of a data use agreement that a data recipient provided false information during the application process, the Commission, acting through the Executive Director, may take one or more of the following administrative and judicial enforcement actions, depending upon the facts, circumstances, and gravity of the acts of noncompliance:</text> <paragraph num="(1)"> <text>Terminate a data recipient’s current access to data;</text> </paragraph> <paragraph num="(2)"> <text>Suspend a data recipient’s current access to data for a period of time:</text> <paragraph num="(a)"> <text>Subject to conditions that a data recipient must satisfy before the suspension may be lifted and access to data reinstated; or</text> </paragraph> <paragraph num="(b)"> <text>If required by the Executive Director, until a data recipient enters into a new data use agreement that requires compliance with a corrective action plan addressing the acts of noncompliance;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Require a data recipient to suspend or retract for a designated period of time a product that has been created or published from the data, subject to conditions that a data recipient must satisfy before the suspension or retraction may be lifted;</text> </paragraph> <paragraph num="(4)"> <text>Demand the secure destruction or return of data and require documentary proof that all data released to a data recipient has been destroyed;</text> </paragraph> <paragraph num="(5)"> <text>Terminate a data use agreement; or</text> </paragraph> <paragraph num="(6)"> <text>Prohibit a data recipient from submitting a new application requesting data for a designated period of time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Executive Director may refer an instance of unauthorized access, use, or disclosure of data to the Office of the Attorney General of Maryland, the Maryland State’s Attorney Office, or any other appropriate State or federal law enforcement authority.</text> </paragraph> <paragraph num="C."> <text>The Commission, based upon information provided by the Executive Director, may seek any appropriate administrative and judicial remedy allowed by State or federal law for:</text> <paragraph num="(1)"> <text>Failing to comply with any terms and conditions for accessing and using data; and</text> </paragraph> <paragraph num="(2)"> <text>Any instance of unauthorized or impermissible access, use, and disclosure of data.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-103(c)(3), 19-109(a)(1) and (7) and (b)(5), and 19-133(d), and 19-134, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 1995 (22:12 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 15, 2001 (28:20 Md. R. 1783)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 15, 2001 (28:20 Md. R. 1783); October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 10, 1997 (24:5 Md. R. 412)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective October 15, 2001 (28:20 Md. R. 1783)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 under Small Group Market Data Collection repealed and new Regulations .01—.14 under Data Release adopted effective December 13, 2021 (48:25 Md. R. 1079)</annotation> </annotations> </chapter> <chapter num="06" heading="Maryland Medical Care Data Base and Data Collection"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <text>These regulations establish appropriate methods for collecting and compiling Statewide data on selected health care services provided either under a Maryland contract or to Maryland residents by health care practitioners and facilities:</text> <paragraph num="A."> <text>From payors;</text> </paragraph> <paragraph num="B."> <text>From third-party administrators;</text> </paragraph> <paragraph num="C."> <text>From managed behavioral health care organizations;</text> </paragraph> <paragraph num="D."> <text>From pharmacy benefit managers; and</text> </paragraph> <paragraph num="E."> <text>Regarding providers for whom the Maryland Health Care Commission otherwise receives data.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adjudicated” means paid, resolved, or settled.</text> </paragraph> <paragraph num="(2)"> <text>“Behavioral health care services” means procedures or services rendered by a health care practitioner for the treatment of mental health or substance use disorders.</text> </paragraph> <paragraph num="(3)"> <text>“Capitated encounter” means a health care visit in which a health care practitioner or office facility provides a service pursuant to an agreement with a reporting entity for reimbursement on an aggregate fixed sum or per capita basis.</text> </paragraph> <paragraph num="(4)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(5)"> <text>“Crosswalk” means a list of all codes and their definitions in a separate file that maps to a specific data field.</text> </paragraph> <paragraph num="(6)"> <text>“Executive Director” means the Executive Director of the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(7)"> <text>“Fee-for-service encounter” means a health care visit in which a health care practitioner or office facility provided a health care service for which a claim was submitted to a reporting entity for payment, and payment was made on a per service basis.</text> </paragraph> <paragraph num="(8)"> <text>“General health benefit plan” means:</text> <paragraph num="(a)"> <text>A hospital or health care policy, contract, or certificate issued by a payor as defined in this section;</text> </paragraph> <paragraph num="(b)"> <text>A behavioral health services plan;</text> </paragraph> <paragraph num="(c)"> <text>A pharmacy benefit management services plan;</text> </paragraph> <paragraph num="(d)"> <text>A vision plan certified by the Maryland Health Benefit Exchange; or</text> </paragraph> <paragraph num="(e)"> <text>A dental plan certified by the Maryland Health Benefit Exchange.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Health Benefit Exchange” or “Exchange” means the Maryland Health Benefit Exchange established as a public corporation under Insurance Article, §31-102, Annotated Code of Maryland, and includes the Individual Exchange and the Small Business Health Operations Program (SHOP) Exchange.</text> </paragraph> <paragraph num="(10)"> <text>“Health care service” means a health or medical care procedure or service rendered by a health care practitioner that:</text> <paragraph num="(a)"> <text>Provides testing, diagnosis, or treatment of human disease or dysfunction; or</text> </paragraph> <paragraph num="(b)"> <text>Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of human disease or dysfunction.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Health information exchange” or “HIE” means an entity that creates or maintains an infrastructure that provides organizational and technical capabilities in an interoperable system for the electronic exchange of protected health information among participating organizations not under common ownership, in a manner that ensures the secure exchange of protected health information to provide care to patients. An HIE does not include an entity that is acting solely as a health care clearinghouse, as defined in 45 CFR §160.103. A payor may act as, operate, or own an HIE subject to these regulations.</text> </paragraph> <paragraph num="(12)"> <text>“HIPAA” means the U.S. Health Insurance Portability and Accountability Act of 1996, P.L.104-191, as implemented and amended in federal regulations, including the HIPAA Privacy and Security rules, 45 CFR §§160 and 164, as may be amended, modified, or renumbered and including as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act.</text> </paragraph> <paragraph num="(13)"> <text>“Managed behavioral health care organization” means a company, organization, private review agent, or subsidiary that:</text> <paragraph num="(a)"> <text>Contracts with a payor as defined in this section to provide, undertake to arrange, or administer behavioral health care services to members; or</text> </paragraph> <paragraph num="(b)"> <text>Otherwise makes behavioral health care services available to members through contracts with health care providers.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Managed care organization” or “MCO” means:</text> <paragraph num="(a)"> <text>A certified health maintenance organization that is authorized to receive medical assistance prepaid capitation payments; or</text> </paragraph> <paragraph num="(b)"> <text>A corporation that:</text> <paragraph num="(i)"> <text>Is a managed care system that is authorized to receive medical assistance prepaid capitation payments;</text> </paragraph> <paragraph num="(ii)"> <text>Enrolls only program recipients or individuals or families served under the Maryland Children's Health Program; and</text> </paragraph> <paragraph num="(iii)"> <text>Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Master Patient Index” means a database that maintains a unique index identifier for each patient whose protected health information may be accessible through the HIE and is used to cross reference patient identifiers across multiple participating organizations to allow for patient search, patient matching, and consolidation of duplicate records.</text> </paragraph> <paragraph num="(16)"> <text>“Medical Care Data Base” or “MCDB” means the data base established and maintained by the Commission pursuant to Health-General Article, §19-133, Annotated Code of Maryland, that collects eligibility data, professional services claims, institutional services claims, pharmacy claims, and provider data for Maryland residents enrolled in private insurance, Medicaid, or Medicare. The MCDB is Maryland’s All Payer Claims Data Base.</text> </paragraph> <paragraph num="(17)"> <text>“MCDB Submission Manual” or “Manual” means the composition of data reporting requirements with guidelines of technical specifications, layouts, and definitions necessary for filing the reports required by this chapter.</text> </paragraph> <paragraph num="(18)"> <text>“Non-Fee-for-Service Expenses Report” means a report with information on lump sum payments made by a reporting entity to providers as part of the reporting entity’s compensation to the providers for non-claims-based services.</text> </paragraph> <paragraph num="(19)"> <text>“Office facility” means a freestanding facility providing:</text> <paragraph num="(a)"> <text>Ambulatory surgery;</text> </paragraph> <paragraph num="(b)"> <text>Radiologic or diagnostic imagery; or</text> </paragraph> <paragraph num="(c)"> <text>Laboratory services.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Payor” means:</text> <paragraph num="(a)"> <text>An insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A health maintenance organization (HMO) that holds a certificate of authority in Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>For Medical Care Data Base purposes:</text> <paragraph num="(i)"> <text>A third-party administrator registered under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A managed behavioral health care organization as defined in this section; or</text> </paragraph> <paragraph num="(iii)"> <text>A pharmacy benefit manager.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, representative of any kind, partnership, firm, association, corporation, or other entity.</text> </paragraph> <paragraph num="(22)"> <text>“Pharmacy benefit management services” means:</text> <paragraph num="(a)"> <text>The procurement of prescription drugs at a negotiated rate for dispensation within the State to beneficiaries;</text> </paragraph> <paragraph num="(b)"> <text>The administration or management of prescription drug coverage provided by a purchaser for beneficiaries; and</text> </paragraph> <paragraph num="(c)"> <text>Any of the following services provided with regard to the administration of prescription drug coverage:</text> <paragraph num="(i)"> <text>Mail service pharmacy;</text> </paragraph> <paragraph num="(ii)"> <text>Claims processing, retail network management, and payment of claims to pharmacies for prescription drugs dispensed to beneficiaries;</text> </paragraph> <paragraph num="(iii)"> <text>Clinical formulary development and management services;</text> </paragraph> <paragraph num="(iv)"> <text>Rebate contracting and administration;</text> </paragraph> <paragraph num="(v)"> <text>Patient compliance, therapeutic intervention, and generic substitution programs; or</text> </paragraph> <paragraph num="(vi)"> <text>Disease management programs.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>“Pharmacy benefit management services” does not include any service provided by a nonprofit health maintenance organization that operates as a group model, provided that the service is provided solely to a member of the nonprofit health maintenance organization and is furnished through the internal pharmacy operations of the nonprofit health maintenance organization.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Pharmacy benefit manager” means a person who performs pharmacy benefit management services and is registered as a pharmacy benefit manager under Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Practitioner” means a person who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program.</text> </paragraph> <paragraph num="(25)"> <text>“Practitioner federal tax ID number” means the federal tax identification number of the practitioner, practice, supplier or office facility receiving reimbursement for the service provided.</text> </paragraph> <paragraph num="(26)"> <text>“Practitioner/supplier ID number” means the unique identification number used by the reporting entity to identify the particular practitioner or supplier.</text> </paragraph> <paragraph num="(27)"> <text>“Primary diagnosis” means the principal diagnosis for the health care service visit.</text> </paragraph> <paragraph num="(28)"> <text>"Provider” means:</text> <paragraph num="(a)"> <text>A practitioner;</text> </paragraph> <paragraph num="(b)"> <text>A facility where health care is provided to patients or recipients, including:</text> <paragraph num="(i)"> <text>A facility, as defined in Health-General Article, §10-101(e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A health maintenance organization, as defined in Health-General Article, §19-701(g), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>An outpatient clinic; and</text> </paragraph> <paragraph num="(vi)"> <text>A medical laboratory; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The agents and employees of a facility who are licensed or otherwise authorized to provide health care, the officers and directors of a facility, and the agents and employees of a health care provider who are licensed or otherwise authorized to provide health care.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Qualified dental plan” means a dental plan certified by the Maryland Health Benefit Exchange that provides limited scope dental benefits, as described in §1311(c) of the Affordable Care Act and Insurance Article, §31-115, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(30)"> <text>“Qualified health plan” means a general health benefit plan that has been certified by the Maryland Health Benefit Exchange to meet the criteria for certification described in §1311(c) of the Affordable Care Act and Insurance Article, §31-115, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“Qualified vision plan” means a vision plan certified by the Maryland Health Benefit Exchange that provides limited scope vision benefits, as described in the Insurance Article, §31-108(b)(3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Reporting entity” means a payor, third-party administrator, managed behavioral health care organization, or pharmacy benefit manager that is designated by the Commission to provide reports consistent with this chapter to be collected and compiled into the Medical Care Data Base.</text> </paragraph> <paragraph num="(33)"> <text>“State-designated health information exchange” or “State-designated HIE” means an HIE designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth in Health-General Article, §19-143, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Supplier” means a person or entity, including a health care practitioner, which supplies medical goods or services.</text> </paragraph> <paragraph num="(35)"> <text>“Third-party administrator” means a person that is registered as an administrator under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Persons Designated to Provide Data to the Commission."> <paragraph num="A."> <text>Reporting Entities. By December 31 of each year, the Commission shall make available a list of each payor, third-party administrator, pharmacy benefit manager, and managed behavioral health care organization meeting the criteria for designation as a reporting entity and who shall file the reports under this chapter in the following year.</text> <paragraph num="(1)"> <text>The Commission shall designate as a reporting entity each payor and third-party administrator whose total lives covered exceeds 1,000, as reported to the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall designate as a reporting entity each payor offering a qualified health plan, qualified dental plan, or qualified vision plan certified by the Maryland Health Benefit Exchange, under Insurance Article, §31-115, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall designate as a reporting entity each payor that is a managed care organization participating in the Maryland Medical Assistance Program in connection with the enrollment of an individual in the Maryland Medical Assistance Program or the Maryland Children's Health Program.</text> </paragraph> <paragraph num="(4)"> <text>The Commission may conduct surveys as needed to fulfill the purposes of the MCDB.</text> <paragraph num="(a)"> <text>The Commission may conduct a survey of any reporting entity to determine if the reporting entity is required to report data or for other purposes consistent with this chapter.</text> </paragraph> <paragraph num="(b)"> <text>If necessary, the Commission may institute an annual survey to obtain information needed to determine and designate a third-party administrator whose annual covered lives report filed with the Maryland Insurance Administration does not delineate the number of covered lives for the following:</text> <paragraph num="(i)"> <text>A behavioral health services plan; or</text> </paragraph> <paragraph num="(ii)"> <text>A pharmacy benefit management services plan.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A reporting entity shall timely report information sought by the Commission in a survey.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Data Otherwise Collected by the Commission from Reporting Entities or Providers.</text> <paragraph num="(1)"> <text>A reporting entity’s reports are considered submitted to the Commission if the reports are contained within the submission of another reporting entity.</text> </paragraph> <paragraph num="(2)"> <text>For purposes of supplementing the MCDB, the Commission may include information that the Commission has otherwise received regarding providers and services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Data Collected from other State or Federal Agencies. The Commission designates and selects any data obtained from a state or federal agency to be a part of the MCDB for use consistent with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Process for Submitting Data."> <paragraph num="A."> <text>The Commission shall provide each reporting entity with an annual update to the MCDB Submission Manual, and each current Manual update available, as specified in Regulation .15 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Each reporting entity shall provide each of the following reports, if applicable:</text> <paragraph num="(1)"> <text>Professional Services Data Report;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy Data Report;</text> </paragraph> <paragraph num="(3)"> <text>Provider Directory Report;</text> </paragraph> <paragraph num="(4)"> <text>Institutional Services Data Report;</text> </paragraph> <paragraph num="(5)"> <text>Eligibility Data Report;</text> </paragraph> <paragraph num="(6)"> <text>Plan Benefit Design Report;</text> </paragraph> <paragraph num="(7)"> <text>Dental Services Data Report; and</text> </paragraph> <paragraph num="(8)"> <text>Non-Fee-for-Service Expenses Report.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall provide each required report to the Commission through the Maryland Medical Assistance Program, which will provide the MCO reports and related information to the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Time Period for Submitting Data Reports."> <paragraph num="A."> <text>Unless a different reporting time period is specified in the MCDB Submission Manual pursuant to §B of this regulation, each reporting entity shall submit to the Commission a complete set of the entity’s data for claims paid during each quarter of a calendar year in the form and manner described in Regulations .07—.14 of this chapter within 2 months of the last day in the applicable quarter.</text> </paragraph> <paragraph num="B."> <text>Each reporting entity shall submit at least quarterly to the Commission a complete set of the reporting entity’s data for claims paid during the specific time period in the form and manner described in Regulations .07—.14 of this chapter and within the time period specified in the MCDB Submission Manual, unless a more frequent submission schedule is instituted by the Commission pursuant to §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>Before instituting a requirement that a reporting entity submit data for claims paid more frequently than quarterly, as required in §§A and B of this regulation, the Commission shall:</text> <paragraph num="(1)"> <text>Establish a multi-stakeholder group consisting of representatives of reporting entities, involved State agencies, and other stakeholders, as appropriate, to discuss the benefits and costs of expanding data collection; and</text> </paragraph> <paragraph num="(2)"> <text>Include a transition period for reporting entities to adjust to the new data submission schedule and process.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Protection of Confidential Information in Submissions."> <paragraph num="A."> <text>To assure that confidential records or information are protected, each reporting entity shall encrypt each of the following data elements in such a manner that each unique value for a data element produces an identical unique encrypted data element:</text> <paragraph num="(1)"> <text>Patient or enrollee identifier; and</text> </paragraph> <paragraph num="(2)"> <text>Internal subscriber contract number.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to maintain a consistent and unique identifier for each patient across providers, payors, and services, the Commission shall:</text> <paragraph num="(1)"> <text>Provide selected data to the State-designed HIE for the creation and encryption of a Master Patient Index; and</text> </paragraph> <paragraph num="(2)"> <text>Include Master Patient Index identifiers received from the State-designated HIE in each eligibility data report submitted under Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each reporting entity shall maintain the security and preserve the confidentiality of the encrypted data.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Professional Services Data Report Submission."> <paragraph num="A."> <text>Each reporting entity shall submit a professional services data report that provides the data for each fee-for-service and capitated encounter, including fee-for-service equivalents prices for capitated services, provided by a health care practitioner or office facility. This report shall include all health care services provided:</text> <paragraph num="(1)"> <text>To each Maryland resident insured by that entity under a fully insured or a self-insured contract; and</text> </paragraph> <paragraph num="(2)"> <text>To each non-Maryland resident insured under a Maryland contract.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each professional services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Pharmacy Data Report Submission."> <paragraph num="A."> <text>Each reporting entity shall submit a pharmacy data report for each prescription drug encounter for services provided by a pharmacy located in or out of the State. This report shall include all pharmacy services provided to each Maryland resident insured under a fully insured contract or a self-insured contract, and to each non-Maryland resident insured under a Maryland contract.</text> </paragraph> <paragraph num="B."> <text>Each pharmacy data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Provider Directory Report Submission."> <paragraph num="A."> <text>Each reporting entity shall submit a provider directory report detailing each health care practitioner or supplier that provided services to any enrollee of that reporting entity during the reporting period. This report shall contain information for each in-State Maryland practitioner or supplier, and for each out-of-State practitioner or supplier that has served a Maryland resident or a non-Maryland resident under a Maryland contract.</text> </paragraph> <paragraph num="B."> <text>Each provider directory report shall include a crosswalk to each practitioner or supplier ID listed in the professional services data report submitted under Regulation .07 of this chapter or the pharmacy data report submitted under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Each provider directory report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Institutional Services Data Report Submission."> <paragraph num="A."> <text>Each reporting entity shall submit an institutional services data report that reports all institutional health care services provided to each Maryland resident insured under a fully insured contract or self-insured contract, and each non-Maryland resident insured under a Maryland contract, whether those services were provided:</text> <paragraph num="(1)"> <text>By a health care facility located in-State or out-of-State; or</text> </paragraph> <paragraph num="(2)"> <text>Under a general health benefit plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each institutional services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Eligibility Data Report Submission."> <paragraph num="A."> <text>Each reporting entity shall submit an eligibility data report that provides information on the characteristics of each enrollee that is a Maryland resident insured under a fully insured contract or a self-insured contract, and each enrollee that is a non-Maryland resident insured under a Maryland contract, for services covered under each policy or contract issued by the reporting entity that are subject to this chapter.</text> </paragraph> <paragraph num="B."> <text>Each eligibility data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Plan Benefit Design Report."> <text>Each plan benefit design report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Dental Services Data Report."> <text>Each dental services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Non-Fee-for-Service Expenses Report."> <text>Each non-fee-for-service expenses report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Report Submission Methods."> <paragraph num="A."> <text>When a reporting entity collects more granular information than required under this chapter, the reporting entity shall provide a conversion table that describes how internal values are mapped to each required category.</text> </paragraph> <paragraph num="B."> <text>The MCDB Submission Manual shall contain technical specifications, layouts, required reports, and definitions for each reporting entity.</text> <paragraph num="(1)"> <text>The Commission shall provide an annual MCDB Submission Manual by November 21 of each year to be used for the reporting periods in the subsequent year.</text> </paragraph> <paragraph num="(2)"> <text>The Commission may correct incomplete or erroneous information in the MCDB Submission Manual as necessary, and provide notice of each correction on the Commission website and by email to the contact persons designated by the reporting entities.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall timely post the annual MCDB Submission Manual on the Commission website and provide notice in the Maryland Register.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Master Patient Index.</text> <paragraph num="(1)"> <text>The Commission may require that each reporting entity electronically submit sufficient demographic information on each enrollee to create a Master Patient Index.</text> </paragraph> <paragraph num="(2)"> <text>The Commission may require that a reporting entity provide the information required under §C(1) of this regulation to the State-designated HIE solely for the purpose of creating a Master Patient Index.</text> </paragraph> <paragraph num="(3)"> <text>The information required under §C(1) of this regulation shall be submitted in a manner consistent with all relevant federal and State privacy laws and regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Request for an Extension of Time."> <paragraph num="A."> <text>A reporting entity may request an extension of an additional 30 days time to provide the required data report.</text> </paragraph> <paragraph num="B."> <text>For a 30-day extension request to be considered by Commission staff, the reporting entity shall submit a written request to the Executive Director at least 30 days before the required submission date that includes:</text> <paragraph num="(1)"> <text>The extraordinary cause necessitating the extension request; and</text> </paragraph> <paragraph num="(2)"> <text>A proposed date, which is no more than 30 days after the initial required submission date, when the reporting entity will provide the required data to the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Request for an Annual Waiver or Format Modification."> <paragraph num="A."> <text>Annual Waiver Request.</text> <paragraph num="(1)"> <text>When a reporting entity is not able to submit a data report as set forth in this chapter, the reporting entity shall file with the Commission by March 15 of the year for which a waiver is sought a written request for an annual waiver that shall include an explanation of why the reporting entity is not able to provide the data report, including any extraordinary circumstances.</text> </paragraph> <paragraph num="(2)"> <text>Supporting Documentation Required for an Annual Waiver Request.</text> <paragraph num="(a)"> <text>A general health benefit plan shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(b)"> <text>A qualified health benefit plan, a qualified vision plan or a qualified dental plan shall include a relevant document from the Health Benefit Exchange indicating that the entity’s filing of the data is not required.</text> </paragraph> <paragraph num="(c)"> <text>A third party administrator shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(d)"> <text>A behavioral health care services organization shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(e)"> <text>A pharmacy benefit manager shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Format Modification Request. When a reporting entity is not able to provide all the information required in Regulations .07—.14 of this chapter, the reporting entity shall file with the Commission a written request for a format modification at least 30 days before the applicable submission date that shall include:</text> <paragraph num="(1)"> <text>The extraordinary circumstances surrounding the reporting entity’s inability to submit values for a specific data element;</text> </paragraph> <paragraph num="(2)"> <text>An explanation of each reason why a format modification is necessary; and</text> </paragraph> <paragraph num="(3)"> <text>A detailed description of the reporting entity’s proposed layout or submission method, or both, when applicable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Executive Director shall provide the reporting entity with a written decision within 30 days of the filing of a completed request.</text> </paragraph> <paragraph num="D."> <text>Appeal of the Executive Director’s Decision. The aggrieved party may file a written request for Commission review of the Executive Director’s written decision within 14 days of the decision.</text> <paragraph num="(1)"> <text>The Commission may provide an opportunity for the reporting entity to present argument to the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The Commission may affirm, reverse, or modify the decision of the Executive Director.</text> </paragraph> <paragraph num="(3)"> <text>The decision by the Commission shall be by a majority of the quorum present and voting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Failure to File Data Reports."> <paragraph num="A."> <text>A reporting entity that does not timely file a data report in compliance with the MCDB Submission Manual may be subject to monetary penalties as provided in COMAR 10.25.12.</text> </paragraph> <paragraph num="B."> <text>In accordance with COMAR 10.25.12.01C, a data report that is substantially incomplete or inaccurate is not timely filed within the meaning of §A of this regulation and may be subject to monetary penalties as provided in COMAR 10.25.12.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Summaries and Compilations."> <text>The Commission shall develop public-use data, summaries, and compilations for public disclosure, pursuant to Health-General Article, §§19-103(c)(3), 19-109(a)(6), and 19-134, Annotated Code of Maryland, in compliance with all applicable federal and State laws and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-101, 19-103(c)(3), (4), (7), and (8), 19-109(a)(1), (6), and (7), 19-133, 19-134, and 19-137, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 15, 1996 (23:1 Md. R. 26)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 9, 1998 (25:5 Md. R. 369)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, D, F amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B, D amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A, D amended effective October 18, 1999 (26:21 Md. R. 1629)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.14 repealed and new Regulations .01—.14 adopted effective August 21, 2000 (27:16 Md. R. 1525)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective December 23, 2002 (29:25 Md. R. 1983)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.14 repealed and new Regulations .01—.17 adopted effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 repealed and new Regulations .01—.19 adopted as an emergency provision effective January 9, 2014 (41:3 Md. R. 200); adopted permanently effective March 17, 2014 (41:5 Md. R. 344)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 18, 2021 (48:21 Md. R. 889)</annotation> </annotations> </chapter> <chapter num="07" heading="Certification of Electronic Health Networks and Medical Care Electronic Claims Clearinghouses"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter provides for the certification of electronic health networks and medical care electronic claims clearinghouses that operate in Maryland. Payors that accept electronic health care transactions originating in Maryland may only accept electronic health care transactions from electronic health networks or medical care electronic claims clearinghouses that obtain certification pursuant to this chapter.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to:</text> <paragraph num="(1)"> <text>An electronic health network, as defined in Regulation .02 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The State-designated health information exchange or State-designated HIE as designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland..</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adjudication of claims” means the activities necessary for the adjudication or subrogation of a health benefit claim that has been filed or may be filed by a patient, or with the authorization of a patient on the patient’s behalf, including:</text> <paragraph num="(a)"> <text>Determinations of eligibility or coverage, including coordination of benefits or the determination of cost-sharing amounts;</text> </paragraph> <paragraph num="(b)"> <text>Reasonable prospective, concurrent, or retrospective utilization review or predetermination of benefit coverage;</text> </paragraph> <paragraph num="(c)"> <text>Review, audit, and investigation of a specific claim for payment of benefits with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges;</text> </paragraph> <paragraph num="(d)"> <text>Billing, claims management, collection activities, obtaining payment under a contract for reinsurance, and related health care data processing; and</text> </paragraph> <paragraph num="(e)"> <text>Risk adjustments based on enrollee health status and demographic characteristics.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Disclose” or “disclosure” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of health information, including an acknowledgement that a health record on a particular patient or recipient exists outside the entity holding the information.</text> </paragraph> <paragraph num="(4)"> <text>“Electronic health care transactions” means health care transactions that have been approved by a nationally recognized health care standards development organization (SDO) to support health care informatics, information exchange, systems integration, and other health care applications.</text> </paragraph> <paragraph num="(5)"> <text>“Electronic Health Network (EHN)” means an entity involved in the exchange of electronic health care transactions between electronic health networks, payors, providers, vendors, or other entities.</text> </paragraph> <paragraph num="(6)"> <text>“Entity” means a partnership, firm, association, limited liability company, limited liability partnership, or a public or private corporation.</text> </paragraph> <paragraph num="(7)"> <text>“Grievance” means a written complaint or other information received by the Commission indicating that an MHCC-certified EHN may have violated one of the provisions of Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Health information” means any information, whether oral or recorded in any form or medium, including electronic health information, that:</text> <paragraph num="(a)"> <text>Is created or received by a health care provider, health plan, public health authority, employer, life insurer, or health care clearinghouse; and</text> </paragraph> <paragraph num="(b)"> <text>Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Improvement of patient safety” means actions, strategies, or protocols to prevent health care errors, enhance the quality of care, and ensure a safe health care environment.</text> </paragraph> <paragraph num="(10)"> <text>“Legally protected health information” means the health information with a date of service after May 31, 2022, that is subject to restrictions under Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08, including:</text> <paragraph num="(a)"> <text>Mifepristone data, as defined by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>As specified by the Secretary, the diagnosis, procedure, medication, and other codes related to:</text> <paragraph num="(i)"> <text>Abortion care; and</text> </paragraph> <paragraph num="(ii)"> <text>Sensitive health services, as defined by Health-General, §4-301, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>Medical Care Electronic Claims Clearinghouse.</text> <paragraph num="(a)"> <text>“Medical care electronic claims clearinghouse” is an entity that transmits electronic health care transactions.</text> </paragraph> <paragraph num="(b)"> <text>“Medical care electronic claims clearinghouse” includes an electronic health network.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“MHCC” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(13)"> <text>“MHCC-Certified Electronic Health Network” means an entity that has received certification from the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(14)"> <text>“Mitigation of a public health emergency” means taking actions to lessen the impact of a public health emergency and reduce harm, including implementing preventive measures, managing resources, and coordinating responses to limit disease spread, minimize health risks, and support affected communities effectively.</text> </paragraph> <paragraph num="(15)"> <text>“Payor” means an entity that administers or provides reimbursement for health care benefits on an expense-incurred basis, including:</text> <paragraph num="(a)"> <text>A health maintenance organization issued a certificate of authority in accordance with Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A health insurer or nonprofit health service plan authorized to offer health insurance policies or contracts in this State in accordance with Insurance Article, Title 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>A third-party administrator registered under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>An entity that subcontracts with a third-party payor to provide specialty health care services including, but not limited to, a dental benefit payor, a vision benefit payor, a mental health benefit payor, and a pharmacy benefit manager; or</text> </paragraph> <paragraph num="(e)"> <text>A managed care organization that contracts with the Maryland Medical Assistance program to provide health services to Maryland Medical Assistance recipients in accordance with Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“State-designated health information exchange” or “State-designated HIE” means a health information exchange designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“State health improvement program” means a State initiative designed to enhance public health through strategic planning, targeted interventions, and collaboration with stakeholders and the federal government, including State efforts in support of the Total Cost of Care model and successor models agreed to by the federal government and the State.</text> </paragraph> <paragraph num="(18)"> <text>“Qualified accreditation or certification organization” means a nationally recognized entity that has established privacy and security standards for electronic health networks and accredits or certifies networks that meet those standards.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Duration of Certification."> <text>A certification is valid for a 2-year period from the date of certification unless withdrawn by the Commission prior to the end of the 2-year period.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedure to Obtain Certification."> <paragraph num="A."> <text>Application for Certification. An EHN seeking Commission certification shall:</text> <paragraph num="(1)"> <text>Complete and submit an application for MHCC Electronic Health Network Certification in the form and manner specified by the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Provide evidence that it has been granted either candidacy status or full accreditation or certification status by a qualified accreditation or certification organization; and</text> </paragraph> <paragraph num="(3)"> <text>Meet all Commission certification requirements set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fees.</text> <paragraph num="(1)"> <text>An application fee shall be paid to the Commission within 30 days of receipt of an invoice from the Commission.</text> </paragraph> <paragraph num="(2)"> <text>For an electronic health network with one operational site, an application fee of $400 shall be paid within 30 days of receipt of an invoice from the Commission.</text> </paragraph> <paragraph num="(3)"> <text>For an electronic health network with more than one operational site, an application fee of $400, plus a $200 fee for each additional operational site, shall be paid within 30 days of receipt of an invoice from the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards for Certification."> <paragraph num="A."> <text>In order to obtain certification, an applicant shall:</text> <paragraph num="(1)"> <text>Provide evidence that the applicant is accredited or certified by a qualified accreditation or certification organization; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the following standards for certification:</text> <paragraph num="(a)"> <text>Demonstrate compliance with the HIPAA privacy standards set forth in 45 CFR Parts 160 and 164;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrate compliance with HIPAA security standards set forth in 45 CFR Parts 160, 162, and 164;</text> </paragraph> <paragraph num="(c)"> <text>Provide an attestation signed by an officer of the applicant that to the extent required by Health-General Article, §4-302.5, Annotated Code of Maryland, the applicant:</text> <paragraph num="(i)"> <text>Possesses the technological capability to filter and restrict from disclosure legally protected health information;</text> </paragraph> <paragraph num="(ii)"> <text>Is parsing restricted codes and conveying all other information in the health record that is not prohibited by law to exchange; and</text> </paragraph> <paragraph num="(iii)"> <text>Possesses the technological capacity to allow a consumer to request and consent to the exchange of legally protected health information to a specific treating provider;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Provide evidence of ability to measure technical performance and manage future capacity demands;</text> </paragraph> <paragraph num="(e)"> <text>Provide evidence of initial and ongoing employee training in HIPAA privacy and security requirements and customer communication procedures; and</text> </paragraph> <paragraph num="(f)"> <text>Provide additional information requested by the Commission as necessary to determine the applicant's compliance with the standards for certification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission shall issue certification to an applicant that has met all the requirements of §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Candidacy Status."> <paragraph num="A."> <text>Subject to the provisions of this section, the Commission shall issue candidacy status to an applicant that:</text> <paragraph num="(1)"> <text>Has been granted candidacy status by a qualified accreditation or certification organization;</text> </paragraph> <paragraph num="(2)"> <text>Has submitted an application for certification to the Commission;</text> </paragraph> <paragraph num="(3)"> <text>Has paid the application fee; and</text> </paragraph> <paragraph num="(4)"> <text>Has submitted documentation satisfactory to the Commission demonstrating compliance with the requirements set forth in Regulation .05B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission shall issue candidacy status to an applicant that has met all the requirements of §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>An applicant that has achieved candidacy status may transmit electronic health care transactions while completing the certification requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>Candidacy status expires on the expiration of the applicant's candidacy status with a qualified accreditation or certification organization, on the approval of certification by the Commission, or 2 years from the date that candidacy status was issued.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Notice Required."> <paragraph num="A."> <text>Within 30 days after the closure, sale, lease, assignment, or transfer of an MHCC-certified EHN to any person or entity, the MHCC-certified EHN and the other party to the transaction shall notify the Commission of that event. Upon such notice, the Commission may seek further information to determine whether the certification should remain in effect notwithstanding the sale or other event.</text> </paragraph> <paragraph num="B."> <text>At least 60 days before changing its address, an MHCC-certified EHN shall notify the Commission of its intent and provide the Commission with the new address.</text> </paragraph> <paragraph num="C."> <text>At least 60 days before changing its name, an MHCC-certified EHN shall notify the Commission of its intent to change its name and provide the Commission with the new name.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Renewal of Certification."> <paragraph num="A."> <text>Application for renewal of certification shall be made at least 60 days before the expiration of the certification in a form and manner specified by the Commission.</text> </paragraph> <paragraph num="B."> <text>A recertification fee shall be paid to the Commission at the time the MHCC Electronic Health Network recertification application is filed.</text> </paragraph> <paragraph num="C."> <text>For an electronic health network with one operational site, a recertification fee of $250 shall be paid at the time the application is filed.</text> </paragraph> <paragraph num="D."> <text>For an electronic health network with more than one operational site, a recertification fee of $250, plus a $125 fee for each additional operational site, shall be paid at the time the application is filed.</text> </paragraph> <paragraph num="E."> <text>The Commission shall renew the certification of each renewal applicant that continues to meet the standards set forth in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="F."> <text>The Commission shall issue a renewal of certification to an applicant that has met all the requirements of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Electronic Health Network Transaction Submission."> <paragraph num="A."> <text>An MHCC-certified EHN shall submit electronic health care transactions information in accordance with this regulation to the State-designated HIE for public health and clinical purposes to facilitate:</text> <paragraph num="(1)"> <text>A State health improvement program;</text> </paragraph> <paragraph num="(2)"> <text>Mitigation of a public health emergency;</text> </paragraph> <paragraph num="(3)"> <text>Improvement of patient safety; or</text> </paragraph> <paragraph num="(4)"> <text>The participation of the State in the Center for Medicare and Medicaid Innovation’s Achieving Healthcare Efficiency through Accountable Design (AHEAD) model and any successor models.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Transactions to be Submitted.</text> <paragraph num="(1)"> <text>An MHCC-certified EHN shall submit electronic health care transactions information for services delivered in Maryland to the State-designated HIE that consist of the following transactions:</text> <paragraph num="(a)"> <text>Health care claim or equivalent encounter information (837P and 837I); and</text> </paragraph> <paragraph num="(b)"> <text>Health plan eligibility inquiry and response (270).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Only the EHN that receives the transaction from or returns the transaction to the originating submitter directly is required to submit the transaction information to the State-designated HIE.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission may request the submission of other electronic administrative transactions adopted by the Department of Health and Human Services.</text> </paragraph> <paragraph num="D."> <text>An MHCC-certified EHN may include transactions related to pharmaceuticals covered by medical benefits with its submission under §B of this regulation if excluding that data would be burdensome.</text> </paragraph> <paragraph num="E."> <text>Electronic Health Care Transactions Technical Submission Guidance.</text> <paragraph num="(1)"> <text>In consultation with stakeholders, including Commission staff, the State-designated HIE shall develop an Electronic Health Care Transactions Technical Submission Guidance that:</text> <paragraph num="(a)"> <text>Contains detailed technical requirements for submitting electronic health care transaction information to the State-designated HIE;</text> </paragraph> <paragraph num="(b)"> <text>Provides an option for MHCC-certified EHNs to submit electronic health care transactions in a flat file; and</text> </paragraph> <paragraph num="(c)"> <text>To the extent possible, utilizes industry recognized standards.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The State-designated HIE shall:</text> <paragraph num="(a)"> <text>Invite all MHCC-certified EHNs and Commission staff to at least one meeting to discuss the initial development of the Electronic Health Care Transactions Technical Submission Guidance;</text> </paragraph> <paragraph num="(b)"> <text>Invite all MHCC-certified EHNs and Commission staff to at least one meeting prior to making any material updates to the Electronic Health Care Transactions Technical Submission Guidance;</text> </paragraph> <paragraph num="(c)"> <text>Solicit public comments on a draft copy of the initial Electronic Health Care Transactions Technical Submission Guidance, and any material updates to the guidance, by:</text> <paragraph num="(i)"> <text>Publishing the draft guidance on its website; and</text> </paragraph> <paragraph num="(ii)"> <text>Sending the draft guidance to MHCC-certified EHNs and the Commission by e-mail;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Accept comments on the draft Electronic Health Care Transactions Technical Submission Guidance for at least 30 days;</text> </paragraph> <paragraph num="(e)"> <text>Publish a written response to any significant, substantive issues raised in comments; and</text> </paragraph> <paragraph num="(f)"> <text>Consider all stakeholder feedback prior to finalizing the Electronic Health Care Transactions Technical Submission Guidance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The State-designated HIE shall annually submit to Commission staff a final draft of the Electronic Health Care Transactions Technical Submission Guidance for approval, which shall not be unreasonably denied.</text> </paragraph> <paragraph num="(4)"> <text>The State-designated HIE and the Commission shall publish the final, approved Electronic Health Care Transactions Technical Submission Guidance on their websites.</text> </paragraph> <paragraph num="(5)"> <text>An MHCC-certified EHN shall submit electronic health care transaction information to the State-designated HIE in a manner detailed in the most recent version of the Electronic Health Care Transactions Technical Submission Guidance.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Submission Schedule.</text> <paragraph num="(1)"> <text>No later than the last business day of each month, an MHCC-certified EHN shall submit electronic health care transactions information from the preceding month to the State-designated HIE.</text> </paragraph> <paragraph num="(2)"> <text>An MHCC-certified EHN shall submit electronic health transaction information at least once per month, but may submit data more often.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An EHN may not charge a fee to a health care provider, health care payor, or the State-designated HIE for providing the information required under this regulation.</text> </paragraph> <paragraph num="H."> <text>Exemptions.</text> <paragraph num="(1)"> <text>An MHCC-certified EHN may request a 1-year exemption from certain reporting requirements in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An exemption request shall:</text> <paragraph num="(a)"> <text>Be in writing;</text> </paragraph> <paragraph num="(b)"> <text>Identify each specific requirement of this regulation from which the EHN is requesting an exemption;</text> </paragraph> <paragraph num="(c)"> <text>Identify the time period of the exemption, if any;</text> </paragraph> <paragraph num="(d)"> <text>State the reason for each exemption request; and</text> </paragraph> <paragraph num="(e)"> <text>Include information that justifies the exemption request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 45 days after receipt of complete information from an EHN requesting an exemption, the Commission shall take one of the following actions:</text> <paragraph num="(a)"> <text>Grant the exemption by providing written notification; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the exemption request by providing written notification that enumerates the reasons for the denial to the EHN.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Commission may not exempt an MHCC-certified EHN from any requirement within this regulation that is otherwise required by federal or other State law.</text> </paragraph> <paragraph num="(5)"> <text>The Commission may grant an exemption on the following grounds:</text> <paragraph num="(a)"> <text>The absence of functionality in the infrastructure of the EHN that prevents the EHN from complying with the requirement;</text> </paragraph> <paragraph num="(b)"> <text>The requirement would hinder the ability of the EHN to comply with other requirements of this chapter or federal or other State laws; or</text> </paragraph> <paragraph num="(c)"> <text>The requirement would cause an undue burden or hardship on the EHN, such that the EHN would no longer be able to provide EHN services in the State.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>For good cause shown, the Commission may renew a 1-year exemption for an additional 1-year period.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Effective Date.</text> <paragraph num="(1)"> <text>The State-designated HIE shall publish the Electronic Health Care Transactions Technical Submission Guidance within 12 months of the final effective date of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An MHCC-certified EHN shall begin submitting electronic health care transaction information based on the most recent version of the Electronic Health Care Transactions Technical Submission Guidance within 18 months following the initial publication of the Electronic Health Care Transactions Technical Submission Guidance.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Implementation Reporting.</text> <paragraph num="(1)"> <text>Upon request, the State-designated HIE shall submit to the Commission updates on:</text> <paragraph num="(a)"> <text>Its status of developing the Electronic Health Care Transactions Technical Submission Guidance;</text> </paragraph> <paragraph num="(b)"> <text>Its progress in supporting MHCC-certified EHN implementation of the Electronic Health Care Transactions Technical Submission Guidance; and</text> </paragraph> <paragraph num="(c)"> <text>Any disruptions or technology failures that delay implementation and associated impacts, if any.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MHCC-certified EHN shall submit to the Commission at least quarterly:</text> <paragraph num="(a)"> <text>An implementation plan and timeline detailing progress the MHCC-certified EHN has made towards submitting electronic health care transaction information to the State-designated HIE; and</text> </paragraph> <paragraph num="(b)"> <text>Any other information requested by the Commission related to the implementation of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Withdrawal of Certification and Other Penalties."> <paragraph num="A."> <text>The Commission may withdraw certification from an MHCC-certified EHN if the Commission finds that:</text> <paragraph num="(1)"> <text>The MHCC-certified EHN fails to meet the certification standards set forth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A principal or owner of the MHCC-certified EHN, or the entity itself, is convicted of, or pleads guilty or nolo contendere to, a crime related to the operation of the EHN or to a crime involving financial improprieties;</text> </paragraph> <paragraph num="(3)"> <text>A principal or owner of the MHCC-certified EHN, or the entity itself, is notified by a qualified accreditation or certification organization or the Commission of a violation of HIPAA privacy or security standards and fails to take action to remedy the violation within the period of time specified by a qualified accreditation or certification organization or by the Commission;</text> </paragraph> <paragraph num="(4)"> <text>The MHCC-certified EHN disclosed legally protected health information in violation of Health-General Article, §4-302.5, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(5)"> <text>The MHCC-certified EHN fails to submit electronic health care transactions information to the State-designated HIE in accordance with Regulation .09 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Beginning June 1, 2024, a person who knowingly violates Health-General Article, §4-302.5, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to a fine not to exceed $10,000 per day based on:</text> <paragraph num="(1)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(2)"> <text>The cost of investigating the violation; and</text> </paragraph> <paragraph num="(3)"> <text>The person’s prior record of compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A MHCC-certified EHN that fails to submit electronic health transactions information to the State-designated HIE in accordance with Regulation .09 of this chapter may be subject to a financial penalty not to exceed $10,000 per day based on:</text> <paragraph num="(1)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(2)"> <text>The cost of investigating the violation; and</text> </paragraph> <paragraph num="(3)"> <text>Whether the MHCC-certified EHN committed previous violations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Notice Prior to Withdrawal."> <paragraph num="A."> <text>Before withdrawal of certification on one of the bases provided in Regulation .10 of this chapter, the Executive Director shall inform the MHCC-certified EHN, setting forth in writing the reasons for withdrawal.</text> </paragraph> <paragraph num="B."> <text>The notice of withdrawal shall set forth the right of the MHCC-certified EHN to an evidentiary hearing, conducted in accordance with Regulation .12 of this chapter, to show cause why the certification should not be withdrawn.</text> </paragraph> <paragraph num="C."> <text>Within 15 days of receipt of the notice of withdrawal, the MHCC-certified EHN may make a written filing that details the EHN's position and provides supporting documentation, before the Commission takes final action to withdraw the EHN's certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Hearing Procedures."> <paragraph num="A."> <text>Reviewer as Presiding Officer.</text> <paragraph num="(1)"> <text>If an evidentiary hearing is requested, the Executive Director shall appoint a single commissioner to act as reviewer and preside at the hearing.</text> </paragraph> <paragraph num="(2)"> <text>The reviewer shall hold a prehearing conference, at which the reviewer shall:</text> <paragraph num="(a)"> <text>Summarize the rules of procedure governing the evidentiary hearing;</text> </paragraph> <paragraph num="(b)"> <text>Determine the date, time, and place of the evidentiary hearing;</text> </paragraph> <paragraph num="(c)"> <text>Determine the form and manner of the presentation of evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on any pending motions; and</text> </paragraph> <paragraph num="(e)"> <text>Make other decisions as appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Hearing. The reviewer is empowered to:</text> <paragraph num="(1)"> <text>Make all rulings as to evidence, testimony, and the conduct of the evidentiary hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Take other actions consistent with the duties of a reviewer.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Proposed Decision. The reviewer shall prepare a proposed decision and order which shall state the reviewer's determination as to whether the allegations that formed the basis for the hearing are substantiated or not, and if substantiated, include a proposed sanction.</text> </paragraph> <paragraph num="D."> <text>Exceptions.</text> <paragraph num="(1)"> <text>If the proposed decision is adverse to the MHCC-certified EHN, the EHN may submit written exceptions to the proposed decision and order by submitting written argument with citation to supporting documentation from the record.</text> </paragraph> <paragraph num="(2)"> <text>Exceptions shall be filed according to a schedule set by the reviewer, with a party filing exceptions having at least 7 days to file exceptions, and a party filing a response to exceptions having at least 5 days to file a response, unless this period is shortened by agreement of the parties.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Final Decision.</text> <paragraph num="(1)"> <text>The Commission shall issue a final decision based on the record of the proceeding including findings of fact and conclusions of law, that:</text> <paragraph num="(a)"> <text>Finds the allegations to be substantiated and withdraws the MHCC-certified EHN status of the entity;</text> </paragraph> <paragraph num="(b)"> <text>Finds the allegations to be substantiated, but permits the entity to retain MHCC-certified EHN status, with appropriate conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Finds the allegations to be unsubstantiated and continues the entity's MHCC-certified EHN status.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MHCC-certified EHN aggrieved by the Commission's final decision may seek judicial review pursuant to State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-302.1, 4-302, 4-302.2—.3, 4-302.5, 19-103(c)(2), (9) and (10), 19-109(a)(1) and (8), 19-133(d), 19-134, and 19-135(a) and (b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 15, 1996 (23:14 Md. R. 1008)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 3, 2000 (27:6 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 15, 2002 (29:7 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 3, 2000 (27:6 Md. R. 641); December 23, 2002 (29:25 Md. R. 1983)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed and new Regulations .01—.11 adopted effective March 24, 2008 (35:6 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective December 15, 2008 (35:25 Md. R. 2150)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 10, 2025 (52:22 Md. R. 1095)</annotation> </annotations> </chapter> <chapter num="08" heading="Evaluation of Quality and Performance of Health Benefit Plans"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to each carrier that participates in the health benefit plan quality and performance evaluation system.</text> </paragraph> <paragraph num="B."> <text>This chapter requires participation in the health benefit plan quality and performance evaluation system by each carrier that:</text> <paragraph num="(1)"> <text>Holds a certificate of authority in the State;</text> </paragraph> <paragraph num="(2)"> <text>Has a premium volume in Maryland for each category of health benefit plan that exceeds $1,000,000; and</text> </paragraph> <paragraph num="(3)"> <text>Has no more than 65 percent of its Maryland enrollees covered through the Medicaid and Medicare Programs (for each category of health benefit plan), as reported in an annual statement submitted by a carrier to the Commission that includes premium volume and enrollment percentages for the calendar year preceding the reporting period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The evaluation system described in this chapter is designed to address the information needs of consumers and purchasers by providing an assessment of the quality and performance of health benefit plans based on measures endorsed or implemented by nationally recognized organizations involved in quality of care and performance measurement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Carrier” means an insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State in accordance with Insurance Article, Annotated Code of Maryland, or a health maintenance organization that holds a certificate of authority in the State.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>Health Benefit Plan.</text> <paragraph num="(a)"> <text>“Health benefit plan” means a hospital or medical policy, contract, or certificate issued by a carrier.</text> </paragraph> <paragraph num="(b)"> <text>“Health benefit plan” does not include:</text> <paragraph num="(i)"> <text>Coverage for accident or disability income insurance;</text> </paragraph> <paragraph num="(ii)"> <text>Coverage issued as a supplement to liability insurance;</text> </paragraph> <paragraph num="(iii)"> <text>Liability insurance, including general liability insurance and automobile liability insurance;</text> </paragraph> <paragraph num="(iv)"> <text>Workers’ compensation or similar insurance;</text> </paragraph> <paragraph num="(v)"> <text>Automobile or property medical payment insurance;</text> </paragraph> <paragraph num="(vi)"> <text>Credit-only insurance;</text> </paragraph> <paragraph num="(vii)"> <text>Coverage for on–site medical clinics;</text> </paragraph> <paragraph num="(viii)"> <text>Dental or vision insurance;</text> </paragraph> <paragraph num="(ix)"> <text>Long-term care insurance or benefits for nursing home care, home health care, community-based care, or any combination of these;</text> </paragraph> <paragraph num="(x)"> <text>Coverage only for a specified disease or illness;</text> </paragraph> <paragraph num="(xi)"> <text>Hospital indemnity or other fixed indemnity insurance or a hospital or medical policy, contract, or certificate issued by a carrier; or</text> </paragraph> <paragraph num="(xii)"> <text>If offered as a separate insurance policy, Medicare supplemental health insurance, as defined in §1882(g)(1) of the Social Security Act, coverage supplemental to the coverage provided under Chapter 55 of Title 10 of the United States Code, or similar supplemental coverage provided under an employer sponsored plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“HEDIS” means the Healthcare Effectiveness Data and Information Set published by the National Committee for Quality Assurance.</text> </paragraph> <paragraph num="(5)"> <text>“Measurement year” means the calendar year in which services take place and that precedes the reporting period in which the quality and performance measures report is submitted to the Commission or its contractor.</text> </paragraph> <paragraph num="(6)"> <text>“Performance measures report” means the report that a carrier submits to the Commission or its contractor that includes the performance measures calculated in accordance with the HEDIS and other applicable performance measure specifications.</text> </paragraph> <paragraph num="(7)"> <text>“Proprietary information” means information that would put a carrier at a competitive disadvantage if such information were disclosed.</text> </paragraph> <paragraph num="(8)"> <text>“Quality and performance evaluation system” means the process by which the Commission carries out its responsibilities related to the evaluation and reporting of quality and performance of health benefit plans.</text> </paragraph> <paragraph num="(9)"> <text>“Reporting period” means the year in which a carrier submits HEDIS and other performance measures to the Commission or its contractor and which follows the measurement year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Health Benefit Plan Quality and Performance Evaluation System — Implementation."> <paragraph num="A."> <text>Carrier Participation.</text> <paragraph num="(1)"> <text>Each carrier may participate in the health benefit plan quality and performance evaluation system.</text> </paragraph> <paragraph num="(2)"> <text>Each carrier that meets the criteria of Regulation .01B of this chapter is required to participate.</text> </paragraph> <paragraph num="(3)"> <text>A carrier that chooses not to participate in the health benefit plan quality and performance evaluation system must present clear evidence to the Commission that shows that the carrier has no more than $1,000,000 in annual premium volume by category of health benefit plan and no more than 65 percent of its Maryland enrollees covered through the Medicaid and Medicare programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Performance Measures. The Commission shall choose performance measures that are important, feasible, scientifically sound, and actionable, including performance measures that:</text> <paragraph num="(1)"> <text>Are related to the quality and performance of medical services provided by a health benefit plan;</text> </paragraph> <paragraph num="(2)"> <text>Allow for comparisons among health benefit plans;</text> </paragraph> <paragraph num="(3)"> <text>Can be of interest to purchasers, consumers, providers, carriers, or health officials;</text> </paragraph> <paragraph num="(4)"> <text>Can be used to affect changes in performance; and</text> </paragraph> <paragraph num="(5)"> <text>Can be validated through an audit conducted by an independent party for validity, reliability, and comparability.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice by the Commission.</text> <paragraph num="(1)"> <text>Beginning in November 2011, and each November thereafter, the Commission shall provide a dated notice posted on the Commission’s website and a written notice to each carrier required to report under Regulation .01A. of this chapter regarding the following:</text> <paragraph num="(a)"> <text>The required categories of health benefit plans for which HEDIS and other performance measures must be submitted for the upcoming measurement year;</text> </paragraph> <paragraph num="(b)"> <text>The selected HEDIS and other performance measures for each category of health benefit plan to be included in the reporting period; and</text> </paragraph> <paragraph num="(c)"> <text>Quality and performance measures that will be subject to audit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Beginning in December 2011, and each December thereafter, the Commission shall provide a dated notice posted on the Commission’s website and a written notice to each carrier required to report under Regulation .01A of this chapter regarding the following:</text> <paragraph num="(a)"> <text>The required categories of health benefit plans for which HEDIS and other performance measures must be submitted for the upcoming measurement year;</text> </paragraph> <paragraph num="(b)"> <text>The selected HEDIS and other performance measures for each category of health benefit plan to be included in the reporting period;</text> </paragraph> <paragraph num="(c)"> <text>Quality and performance measures that will be subject to audit; and</text> </paragraph> <paragraph num="(d)"> <text>The HEDIS and other performance measures anticipated to be required in the measurement year occurring after the current measurement year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Performance Measures Collection.</text> <paragraph num="(1)"> <text>Beginning in January of each reporting period, a carrier that is required to participate or elects to participate in the health benefit plan quality and performance evaluation system shall collect all required performance measures as follows:</text> <paragraph num="(a)"> <text>Collecting HEDIS measures, a carrier shall follow the specifications contained in the latest version or technical update of HEDIS applicable to the measurement year;</text> </paragraph> <paragraph num="(b)"> <text>Collecting other performance measures, a carrier shall follow specifications published by a nationally recognized organization involved in quality and performance measurement, and in accordance with the notice provided by the Commission in November for the measurement year; and</text> </paragraph> <paragraph num="(c)"> <text>A carrier shall use the specifications, templates, and other documents provided by the Commission, which shall be consistent with those published by the National Committee for Quality Assurance for HEDIS measures and, for non-HEDIS performance measures, required by the Commission, consistent with specifications, templates, or documents published by nationally recognized organizations involved in quality of care and performance measurement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A carrier is not required to submit HEDIS or other performance measures regarding proprietary information contained in descriptive information on health plan management and activities.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide technical assistance and auditing services to a carrier required to report the HEDIS and other performance measures.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Commission Publication of Health Benefit Plan Quality and Performance Evaluation Reports. On or before November 1 of each year, the Commission shall publish on its website one or more reports for use by consumers and purchasers who make health benefit plan enrollment and contracting decisions. The reports shall:</text> <paragraph num="(1)"> <text>Compare quality and performance evaluation results of each health benefit plan on the various HEDIS and other performance measures required by the Commission; and</text> </paragraph> <paragraph num="(2)"> <text>Include information on valid and reliable HEDIS and other performance measures that are comparable on a health benefit plan level, as determined by the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Audits."> <paragraph num="A."> <text>In order to verify the validity, reliability, and comparability of HEDIS and other performance measures required by the Commission, a carrier shall participate in certified audits as specified by the Commission, which may include:</text> <paragraph num="(1)"> <text>A process audit;</text> </paragraph> <paragraph num="(2)"> <text>One or more site visits;</text> </paragraph> <paragraph num="(3)"> <text>Specification and source code review and verification; and</text> </paragraph> <paragraph num="(4)"> <text>Medical records review.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each carrier that is required to participate or elects to participate in the health benefit plan quality and performance evaluation system shall submit audited HEDIS and other performance measures for each designated health benefit plan for the reporting period to the Commission or its contractor by June 1 of the reporting period.</text> </paragraph> <paragraph num="C."> <text>Within the time period specified by the Commission, a carrier shall correct inaccurate or incomplete data contained in its performance measures report that become apparent during the audit or other process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Extension of Time."> <paragraph num="A."> <text>A carrier may request an extension of not more than 30 days for submission of the performance measures report.</text> </paragraph> <paragraph num="B."> <text>A request for an extension of time shall:</text> <paragraph num="(1)"> <text>Be submitted to the Executive Director of the Commission not later than 30 days before the carrier’s performance measures report is due;</text> </paragraph> <paragraph num="(2)"> <text>Explain the good cause for the requested extension; and</text> </paragraph> <paragraph num="(3)"> <text>Propose a reasonable date certain, not to exceed 30 days after the original due date, for submission of the performance measures report.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A carrier may seek Commission review of the Executive Director’s denial of a requested extension of time by filing a written petition for review within 7 days of receipt of the denial.</text> </paragraph> <paragraph num="D."> <text>The Commission shall provide the carrier with an opportunity to present its position to the Commission, and may affirm, reverse, or modify the decision of the Executive Director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalty for Failure to File Reports."> <text>A carrier that is required to participate under Regulation .01B of this chapter and that does not timely file a performance measures report may be subject to the penalties provided in COMAR 10.25.12.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (7), 19-132, and 19-134(c), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 17, 2011 (38:21 Md. R. 1278)</annotation> </annotations> </chapter> <chapter num="09" heading="Requirements for Payers to Designate Electronic Health Networks"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to a third-party payer operating in the State of Maryland, as of July 1, 1997, whose premium volume exceeds $1,000,000 as reported in the most recent annual statement in the hands of the Maryland Insurance Administration as of December 1 of each calendar year.</text> </paragraph> <paragraph num="B."> <text>At the discretion of the Maryland Health Care Commission, this chapter may also apply to third party payers operating in the State of Maryland whose premium volume is $1,000,000 or less.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adjudication” means paid, resolved, or settled.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” or “MHCC” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, P.L. No. 104 — 191, 42 U.S.C. Title XI, Part C.</text> </paragraph> <paragraph num="(4)"> <text>“Deputy Director” means the Deputy Director for Data Systems and Analysis at the Maryland Health Care Commission, or the Deputy Director's designee.</text> </paragraph> <paragraph num="(5)"> <text>“Designate” means to select and to enter into a written agreement with.</text> </paragraph> <paragraph num="(6)"> <text>“Designated EHNs” means MHCC-certified EHNs that have been selected by a payer to submit electronic health care transactions under a written service agreement with the payer on behalf of health care practitioners.</text> </paragraph> <paragraph num="(7)"> <text>Electronic health care transactions" means health care transactions that are defined under HIPAA Transaction and Code Set Standards.</text> </paragraph> <paragraph num="(8)"> <text>“Electronic health network (EHN)” means an entity that processes or facilitates processing of electronic transactions in standard or nonstandard formats, between two or more trading partners in the health care community.</text> </paragraph> <paragraph num="(9)"> <text>“MHCC-certified electronic health network” means an entity that has received certifications from the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(10)"> <text>“Health insurance claim” means a submission of a claim to a third-party payer for payment for services rendered by a health care practitioner in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Third-party payer” or “payer” means a person that administers or provides reimbursement for health care benefits on an expense-incurred basis, including a:</text> <paragraph num="(a)"> <text>Health maintenance organization issued a certificate of authority in accordance with Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Health insurer or nonprofit health service plan authorized to offer health insurance policies or contracts in this State in accordance with Insurance Article, Title 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Third-party administrator registered under Insurance Article, Title 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>Specialty payers, such as Pharmacy Benefit Managers (PBMs); or</text> </paragraph> <paragraph num="(e)"> <text>Managed Care Organizations (MCOs) which contract with Maryland Medicaid to provide health services to Medicaid enrollees.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="EHN Designation."> <paragraph num="A."> <text>Payers shall only contract with MHCC-certified EHNs for the exchange of electronic health care transactions that originate in Maryland.</text> </paragraph> <paragraph num="B."> <text>In the event that a designated EHN loses its MHCC-certified status, the Commission shall provide written notice to the payer of the event.</text> </paragraph> <paragraph num="C."> <text>Within 60 days from the date of the notice, the payer shall notify the Commission that it is no longer using that EHN for the exchange of electronic health care transactions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Designation Requirements."> <text>The payer and its designated EHNs shall enter into a written agreement that shall address at minimum each of the following:</text> <paragraph num="A."> <text>Transaction format specifications;</text> </paragraph> <paragraph num="B."> <text>Transmission methods to be used;</text> </paragraph> <paragraph num="C."> <text>Schedules of events, such as transmission cutoffs, acknowledgment requirements, reporting requirements, and scheduled outages, etc;</text> </paragraph> <paragraph num="D."> <text>Editing requirements and schedules for changes or enhancements;</text> </paragraph> <paragraph num="E."> <text>Charges and terms of payment; and</text> </paragraph> <paragraph num="F."> <text>System access security requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="EDI Progress Report."> <paragraph num="A."> <text>On or before June 30 of each year, each payer shall submit to the Commission an EDI Progress Report Form, describing certain electronic health care transaction activity for the payer's previous calendar year as described in this regulation.</text> </paragraph> <paragraph num="B."> <text>This report shall include:</text> <paragraph num="(1)"> <text>A certification of compliance with Health-General Article, §4-302.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Health care transactions as defined by HIPAA Transaction and Code Set Standards that are submitted or received by Maryland health care providers;</text> </paragraph> <paragraph num="(3)"> <text>Electronic transaction activity between January 1 and December 31 of the previous year; and</text> </paragraph> <paragraph num="(4)"> <text>The total number of HIPAA electronic transactions submitted or received by Maryland health care providers, as defined in the EDI Progress Report Form.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Waiver or Exception Request."> <paragraph num="A."> <text>A payer may submit a written request for waiver or exception of the reporting requirements.</text> </paragraph> <paragraph num="B."> <text>The payer shall:</text> <paragraph num="(1)"> <text>Submit a written request for a waiver or exception to the Deputy Director not later than 30 days before the due date of meeting the reporting/designation requirements; and</text> </paragraph> <paragraph num="(2)"> <text>Explain the reason for the waiver request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Deputy Director shall grant a reasonable request for good cause shown.</text> </paragraph> <paragraph num="D."> <text>A payer may file a written petition for review of a denial of a waiver.</text> </paragraph> <paragraph num="E."> <text>The Commission shall review the decision of the Deputy Director.</text> </paragraph> <paragraph num="F."> <text>The Commission may affirm, reverse, or modify the decision of the Deputy Director after providing the payer with an opportunity to present its position to the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Extension of Time."> <paragraph num="A."> <text>A payer may request an extension of time of up to 60 days for submission of the EDI information.</text> </paragraph> <paragraph num="B."> <text>The payer shall:</text> <paragraph num="(1)"> <text>Submit the request in writing to the Deputy Director for Data Systems and Analysis not later than 30 days before the reporting deadline;</text> </paragraph> <paragraph num="(2)"> <text>Explain the reason for the extension request; and</text> </paragraph> <paragraph num="(3)"> <text>Propose a reasonable date for submission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A payer may file a written petition for review of a denial of an extension of time.</text> </paragraph> <paragraph num="D."> <text>The Commission shall review the decision of the Deputy Director.</text> </paragraph> <paragraph num="E."> <text>After providing the payer with an opportunity to present its position to the Commission, the Commission may affirm, reverse, or modify the decision of the Deputy Director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Penalties for Failure to File a Report."> <paragraph num="A."> <text>Unless the Deputy Director has granted an extension of time, a payer that does not timely file a report is liable for a monetary penalty of $1,000 per day for each day the filing of the report is delayed.</text> </paragraph> <paragraph num="B."> <text>A report that is substantially incomplete or inaccurate is not timely filed.</text> </paragraph> <paragraph num="C."> <text>The filing of a written petition for review of a denial of an extension of time stays the accrual of the monetary penalty under §A of these regulations.</text> </paragraph> <paragraph num="D."> <text>If the Commission affirms the action of the Deputy Director to deny a payer's request for an extension of time, the Commission may impose all penalties in full or in part which, absent the stay, would have accrued during the pendency of the review.</text> </paragraph> <paragraph num="E."> <text>For substantial reasons shown, the Commission may suspend, reduce, or waive any penalty imposed under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Penalties for Failure to Contract with a MHCC-Certified EHN."> <paragraph num="A."> <text>Unless the Deputy Director has granted an extension of time, a payer that does not contract with an MHCC-Certified EHN within 60 days of notification by MHCC that the EHN is not certified, is liable for a monetary penalty of $1,000 per day.</text> </paragraph> <paragraph num="B."> <text>The filing of a written petition for an extension of time stays the accrual of the monetary penalty under §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>If the Commission affirms the action of the Deputy Director to deny a payer's request for an extension of time, the Commission may impose all penalties in full or in part which, absent the stay, would have accrued during the pendency of the review.</text> </paragraph> <paragraph num="D."> <text>For substantial reasons shown, the Commission may suspend, reduce, or waive any penalty imposed under this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-302.1, 19-101, 19-103(c)(9) and (10), 19-109(a)(1), and 19-134(a) and (b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 15, 1996 (23:14 Md. R. 1009)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective May 1, 1997 (24:11 Md. R. 792); emergency status expired October 1, 1997; amended permanently effective October 20, 1997 (24:21 Md. R. 1450)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 23, 2001 (28:14 Md. R. 1322)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 5, 2004 (31:13 Md. R. 994)</annotation> </annotations> </chapter> <chapter num="10" heading="Maryland Trauma Physician Services Fund"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to trauma physicians, trauma health care practitioners, and Maryland Institute for Emergency Medical Services Systems designated trauma centers, Specialty Referral Centers, and rehabilitation hospitals that are affiliated with Maryland Institute for Emergency Medical Services Systems designated trauma centers by common ownership, as defined in Health-General Article, §19-130(a)(3) and (4), Annotated Code of Maryland, that provide trauma care.</text> </paragraph> <paragraph num="B."> <text>Reimbursement.</text> <paragraph num="(1)"> <text>Trauma physicians or trauma health care practitioners seeking reimbursement for uncompensated care provided to trauma patients shall file a claim pursuant to this chapter to receive reimbursement from the Maryland Trauma Physician Services Fund.</text> </paragraph> <paragraph num="(2)"> <text>Trauma physicians or trauma health care practitioners seeking reimbursement for trauma care provided to trauma patients enrolled in the Maryland Medical Assistance Program at the elevated rate shall comply with special billing requirements pursuant to this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Trauma centers seeking reimbursement for costs of maintaining trauma physicians on-call shall file a claim to receive reimbursement from this Fund.</text> </paragraph> <paragraph num="(4)"> <text>Trauma centers seeking reimbursement for standby costs shall file a claim to receive reimbursement from this Fund.</text> </paragraph> <paragraph num="(5)"> <text>Trauma centers seeking trauma grants shall file an application to receive a grant from this Fund in accordance with a process and guidelines developed by the Maryland Health Care Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a person or entity eligible to file a claim to receive reimbursement from the Fund.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Faculty practice plan” means a professional services organization that:</text> <paragraph num="(a)"> <text>Includes physicians; and</text> </paragraph> <paragraph num="(b)"> <text>Is formed to carry out, improve, and supplement the medical education, research, and clinical services program of a medical school.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Fraud” means knowingly and willfully making or causing to be made any false statement or representation of a material fact:</text> <paragraph num="(a)"> <text>In a claim for payment; or</text> </paragraph> <paragraph num="(b)"> <text>In determining eligibility for payments.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Fund” means the Maryland Trauma Physician Services Fund.</text> </paragraph> <paragraph num="(6)"> <text>“HSCRC” means the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="(7)"> <text>“Maryland Trauma Registry” means a clinical trauma registry maintained by MIEMSS that:</text> <paragraph num="(a)"> <text>Monitors and provides information necessary to evaluate major trauma or specialty patient care, outcome, and cost; and</text> </paragraph> <paragraph num="(b)"> <text>Assesses how designated trauma centers and other hospitals comply with the trauma standards, regulations, and protocols.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Medicaid.</text> <paragraph num="(a)"> <text>“Medicaid” means the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396, et seq. and the Children and Families Health Care Program under Title XXI of §4901 of the Balanced Budget Act of 1997, that provide comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(b)"> <text>“Medicaid” includes the services provided by a managed care organization under the State waiver program authorized under §1115 of the Social Security Act, 42 U.S.C. §1396n.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Medicaid differential” means the difference in reimbursement between Medicare and Medicaid for trauma services provided by a trauma physician or trauma health care practitioner to a Medicaid trauma patient in a trauma center.</text> </paragraph> <paragraph num="(10)"> <text>“Medicare economic index (MEI)” means the federal Centers for Medicare and Medicaid Services' measure of inflation in the inputs for providing physician services.</text> </paragraph> <paragraph num="(11)"> <text>“MIEMSS” means the Maryland Institute for Emergency Medical Services Systems.</text> </paragraph> <paragraph num="(12)"> <text>On-Call Physician.</text> <paragraph num="(a)"> <text>“On-call physician” means a trauma physician who commits for a specific time period to be available and respond within a certain amount of time, as defined by MIEMSS, to provide care for a trauma patient in the trauma center.</text> </paragraph> <paragraph num="(b)"> <text>“On-call physician” does not include a physician on standby in a trauma center.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>On-Call Costs.</text> <paragraph num="(a)"> <text>“On-call costs” means the costs to a trauma center to have trauma physicians available and ready to respond to trauma patients within a certain amount of time, as defined by MIEMSS.</text> </paragraph> <paragraph num="(b)"> <text>“On-call costs” does not include standby costs.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“On-call services application” means the difference in reimbursement between Medicare and Medicaid for trauma services provided by a trauma physician or trauma health care practitioner to a Medicaid trauma patient in a trauma center.</text> </paragraph> <paragraph num="(15)"> <text>“Reasonable compensation equivalent (RCE)”:</text> <paragraph num="(a)"> <text>Is a methodology established by Medicare to set limits on what a hospital may claim per physician specialty standby hour; and</text> </paragraph> <paragraph num="(b)"> <text>Has the meaning described in 68 FR 45458 (Aug. 1, 2003).</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Service Period.</text> <paragraph num="(a)"> <text>“Service period” means the time that trauma services are provided from entrance to the trauma center until dismissal or discharge from the trauma center.</text> </paragraph> <paragraph num="(b)"> <text>“Service period” includes a subsequent readmission or outpatient visit to the trauma center, or trauma center-affiliated acute care general hospital, for services that are directly related to the initial trauma injury.</text> </paragraph> <paragraph num="(c)"> <text>“Service period” includes a subsequent admission or outpatient visit to a trauma center-affiliated rehabilitation hospital, or rehabilitation unit of a trauma center.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Specialty referral center” means:</text> <paragraph num="(a)"> <text>The Curtis National Hand Center at Union Memorial Hospital;</text> </paragraph> <paragraph num="(b)"> <text>The Eye Trauma Center at the Wilmer Eye Institute at The Johns Hopkins Hospital; and</text> </paragraph> <paragraph num="(c)"> <text>The Johns Hopkins Health System Burn Program.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Standby costs” means costs to a trauma center for paying physicians to be available on site at the trauma center to treat trauma patients.</text> </paragraph> <paragraph num="(19)"> <text>Trauma Center.</text> <paragraph num="(a)"> <text>“Trauma center” means a hospital designated by the Maryland Institute for Emergency Medical Services Systems (MIEMSS) as:</text> <paragraph num="(i)"> <text>The State primary adult resource center;</text> </paragraph> <paragraph num="(ii)"> <text>A Level I trauma center;</text> </paragraph> <paragraph num="(iii)"> <text>A Level II trauma center;</text> </paragraph> <paragraph num="(iv)"> <text>A Level III trauma center;</text> </paragraph> <paragraph num="(v)"> <text>A pediatric trauma center; or</text> </paragraph> <paragraph num="(vi)"> <text>A specialty referral center as defined in §B(17) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Trauma center” includes a pediatric trauma center that has entered into an agreement with MIEMSS.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Trauma health care practitioner” means a health care practitioner licensed under the Health Occupations Article who provides care in a trauma center-affiliated general acute care hospital or in a trauma center-affiliated rehabilitation hospital during the service period to trauma patients on the Maryland Trauma Registry as defined by the Maryland Institute for Emergency Medical Services Systems (MIEMSS).</text> </paragraph> <paragraph num="(21)"> <text>“Trauma patient” means a patient whose trauma services are documented in the Maryland Trauma Registry.</text> </paragraph> <paragraph num="(22)"> <text>“Trauma physician” means a physician who provides care in a trauma center, trauma center-affiliated general acute care hospital, or in a trauma center-affiliated rehabilitation hospital during the service period to a trauma patient on the Maryland Trauma Registry as defined by the Maryland Institute for Emergency Medical Services Systems (MIEMSS).</text> </paragraph> <paragraph num="(23)"> <text>“Trauma services” means trauma care provided to a trauma patient in a trauma center, trauma center-affiliated general acute care hospital, trauma center-affiliated rehabilitation hospital, or rehabilitation unit of a trauma center.</text> </paragraph> <paragraph num="(24)"> <text>“Uncompensated care” means trauma services provided by a trauma physician or trauma health care practitioner to a trauma patient on the Maryland Trauma Registry who:</text> <paragraph num="(a)"> <text>Has no health insurance, including private health insurance, Medicare Part B coverage, VA health benefits, or CHAMPUS;</text> </paragraph> <paragraph num="(b)"> <text>Is not covered by Workers' Compensation coverage;</text> </paragraph> <paragraph num="(c)"> <text>Is not eligible for Medical Assistance coverage; and</text> </paragraph> <paragraph num="(d)"> <text>Has not paid the full Medicare reimbursement for the trauma care received, even after documented attempts by the trauma physician or trauma health care practitioner to obtain payment.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Uncompensated care shortfall” means the difference in reimbursement between what Medicare pays and what the trauma physician providing care collects from the uncompensated care trauma patient.</text> </paragraph> <paragraph num="(26)"> <text>“Uncompensated services claim” means a CMS 1500 form or an ANSI 837 electronic transaction completed according to Commission specifications and submitted for reimbursement of uncompensated care services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fund Administration."> <paragraph num="A."> <text>The Fund is a special, nonlapsing interest bearing fund that is not subject to State Finance and Procurement Article, §7-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The purpose of the Fund is to subsidize the documented costs:</text> <paragraph num="(1)"> <text>Of uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma services to a trauma patient on the Maryland Trauma Registry;</text> </paragraph> <paragraph num="(2)"> <text>Of undercompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma services to an enrollee of the Medicaid Program who is a trauma patient on the Maryland Trauma Registry;</text> </paragraph> <paragraph num="(3)"> <text>Incurred by a trauma center to maintain trauma physicians on-call as required by MIEMSS;</text> </paragraph> <paragraph num="(4)"> <text>Incurred by a trauma center to maintain patient education, equipment, services, systems, and training as required by MIEMSS, for trauma-related care and not otherwise reimbursed; and</text> </paragraph> <paragraph num="(5)"> <text>Incurred by the Commission to administer the Fund and audit reimbursement requests and trauma grants to assure appropriate payments are made from the Fund.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Administering Agencies. The Commission shall administer the disbursements from the Fund.</text> </paragraph> <paragraph num="D."> <text>Interest. The interest on the Fund shall be accounted for separately and credited to the Fund, and is not subject to State Finance and Procurement Article, §6-226(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Source of Fund Revenue."> <paragraph num="A."> <text>The Fund consists of motor vehicle registration surcharges paid into the Fund in accordance with Transportation Article, §§13-954(b), and 21-902, Annotated Code of Maryland, and regulations promulgated under that authority, and any other money transferred from the General Fund of the State.</text> </paragraph> <paragraph num="B."> <text>The Commission shall make reimbursement from the Fund for:</text> <paragraph num="(1)"> <text>On-call costs;</text> </paragraph> <paragraph num="(2)"> <text>Uncompensated care costs;</text> </paragraph> <paragraph num="(3)"> <text>Medicaid differential payments;</text> </paragraph> <paragraph num="(4)"> <text>Standby expenses to an out-of-State pediatric trauma center that has entered into an agreement with the Maryland Institute for Emergency Medical Services Systems;</text> </paragraph> <paragraph num="(5)"> <text>Grants that may cover costs of trauma centers for trauma related expenses, including physician standby, patient education, equipment, services, systems, training, and other MIEMSS-required incremental trauma costs not otherwise reimbursed; and</text> </paragraph> <paragraph num="(6)"> <text>The Commission's administrative expenses including:</text> <paragraph num="(a)"> <text>The adjudication of uncompensated trauma claims;</text> </paragraph> <paragraph num="(b)"> <text>The audit of providers receiving uncompensated care trauma payments, Medicaid trauma payments, and on-call payments;</text> </paragraph> <paragraph num="(c)"> <text>The audit of managed care organizations payments to trauma physicians and trauma health care practitioners;</text> </paragraph> <paragraph num="(d)"> <text>Enhancements of the MIEMSS Trauma Registry; and</text> </paragraph> <paragraph num="(e)"> <text>Commission personnel costs associated with administering the Fund.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Who May Request Payment."> <paragraph num="A."> <text>A trauma physician or trauma health care practitioner as defined in Regulation .02 of this chapter may request payment under this chapter.</text> </paragraph> <paragraph num="B."> <text>Medicaid and Uncompensated Care Reimbursement.</text> <paragraph num="(1)"> <text>Trauma Practitioner Services. A faculty practice plan, a physician practice, a trauma center on behalf of the trauma physician or trauma health care practitioner, or an individual trauma physician or individual health care practitioner allowed to bill Medicaid may submit requests for payment for trauma services provided to a Medicaid trauma patient or for uncompensated care trauma services if:</text> <paragraph num="(a)"> <text>Those services are provided to a trauma patient during the service period as defined in this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The practitioner meets the definition of a trauma physician or trauma health care practitioner under Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Emergency Physician Services.</text> <paragraph num="(a)"> <text>The total reimbursement from the Fund to emergency physicians practicing at any one trauma center may not exceed $300,000 annually.</text> </paragraph> <paragraph num="(b)"> <text>An emergency room physician:</text> <paragraph num="(i)"> <text>Is eligible for uncompensated care shortfall payments only; and</text> </paragraph> <paragraph num="(ii)"> <text>May not receive Medicaid differential payments or on-call payments from the Fund.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>On-Call Payments. The following trauma centers may apply for on-call payments:</text> <paragraph num="(1)"> <text>A MIEMSS-designated Level I trauma center or pediatric trauma center;</text> </paragraph> <paragraph num="(2)"> <text>Level II and Level III trauma centers; and</text> </paragraph> <paragraph num="(3)"> <text>The Specialty Referral Centers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Standby Payments. An out-of-State pediatric trauma center that has entered into an agreement with MIEMSS may apply for an annual grant to subsidize standby costs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payments for Medicaid Trauma Patients."> <paragraph num="A."> <text>A trauma physician or trauma health care practitioner:</text> <paragraph num="(1)"> <text>Is eligible for payment from the Fund for trauma services provided to a Medicaid trauma patient on the Maryland Trauma Registry on or after July 1, 2024; and</text> </paragraph> <paragraph num="(2)"> <text>May seek reimbursement in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A trauma physician or trauma health care practitioner providing trauma services to a Medicaid trauma patient during the service period shall be reimbursed at the greater of:</text> <paragraph num="(1)"> <text>The Medicaid routine payment rate; or</text> </paragraph> <paragraph num="(2)"> <text>Up to 100 percent of the current Medicare facility-based payment in the Baltimore carrier locality area.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To be eligible for the Medicaid differential payment described in §B of this regulation, diagnosis codes shall meet one of the following two conditions:</text> <paragraph num="(1)"> <text>A diagnosis code shall fall between 800.00 — 959.9; or</text> </paragraph> <paragraph num="(2)"> <text>If a diagnosis code does not fall between 800.0 — 959.9, a supplementary classification of external causes of injury and poisoning (E800 — E999) shall appear as a secondary diagnosis code.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An organization billing on behalf of trauma physicians or trauma health care practitioners eligible for Medicaid differential payments shall designate a trauma service by using the appropriate code in the CPT Modifier field on the electronic claim or on the paper CMS 1500 in accordance with Medicaid claims submission requirements.</text> </paragraph> <paragraph num="E."> <text>To be eligible for the Medicaid differential payment described in §B of this regulation, the place of service code shall have one of the following values:</text> <paragraph num="(1)"> <text>Appropriate code to indicate “acute care inpatient hospital”;</text> </paragraph> <paragraph num="(2)"> <text>Appropriate code to indicate “outpatient hospital”;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate code to indicate “emergency room”; or</text> </paragraph> <paragraph num="(4)"> <text>Appropriate code to indicate “inpatient rehabilitation hospital”.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Maryland Department of Health may apply Medicaid payment rules when adjudicating claims for trauma services to trauma patients.</text> </paragraph> <paragraph num="G."> <text>The Fund shall transfer to the Maryland Department of Health an amount sufficient to fully cover the State's share of expenditures for Medicaid differential payments for that fiscal year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payments for Uncompensated Care Patients."> <paragraph num="A."> <text>A trauma physician or trauma health care practitioner:</text> <paragraph num="(1)"> <text>Is eligible for payment from the Fund for trauma services provided to uncompensated trauma care patients with an admission date on the Maryland Trauma Registry beginning on or after July 1, 2024; and</text> </paragraph> <paragraph num="(2)"> <text>May seek reimbursement in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The cost of uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to a trauma patient as defined in this chapter shall be reimbursed at a rate of up to 100 percent of the current Medicare facility-based payment for a service in the Baltimore carrier locality area, less any amount for trauma physician or trauma health care practitioner services paid by the patient or other third-party payors including, but not limited to, auto insurance, criminal injuries compensation fund, attorneys, or collection agencies, as reported to the Fund on the uncompensated services claim.</text> </paragraph> <paragraph num="C."> <text>An organization billing on behalf of trauma physicians or trauma health care practitioners eligible for uncompensated care payments shall:</text> <paragraph num="(1)"> <text>Designate a trauma service by appropriate coding of the CPT Modifier on the electronic ANSI 837 transaction or paper CMS 1500 claim in accordance with claims submission requirements; and</text> </paragraph> <paragraph num="(2)"> <text>Include the patient's trauma registry number on the electronic claim or on the CMS 1500.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Diagnosis Code.</text> <paragraph num="(1)"> <text>Except as provided in §D(2) of this regulation, a diagnosis code shall fall between 800.00 — 959.9.</text> </paragraph> <paragraph num="(2)"> <text>If a diagnosis code does not fall between 800.0 — 959.9, a supplementary classification of external causes of injury and poisoning (E800 — E999) shall appear as a secondary diagnosis code.</text> </paragraph> </paragraph> <paragraph num="E."> <text>To be eligible for uncompensated care differential payment described in §B of this regulation, the place of service code shall have one of the following values:</text> <paragraph num="(1)"> <text>Appropriate code for “acute care inpatient hospital”;</text> </paragraph> <paragraph num="(2)"> <text>Appropriate code for “outpatient hospital”;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate code for “emergency room”; or</text> </paragraph> <paragraph num="(4)"> <text>Appropriate code for “rehabilitation hospital”.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The uncompensated services claim shall:</text> <paragraph num="(1)"> <text>Document uncompensated care services not previously claimed under the Fund;</text> </paragraph> <paragraph num="(2)"> <text>Exclude services for trauma patients who have applied for assistance through Medicaid, but who have not received a final eligibility determination;</text> </paragraph> <paragraph num="(3)"> <text>Exclude noncovered services that the trauma physician or trauma health care practitioner provided to trauma patients covered by health insurance;</text> </paragraph> <paragraph num="(4)"> <text>Exclude services for trauma patients covered by health insurance for which the trauma physician or trauma health care practitioner failed to comply with the insurer's coverage rules or claim filing requirements; and</text> </paragraph> <paragraph num="(5)"> <text>Have a date of service on the claim not older than 5 years.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Uncompensated care services are eligible for reimbursement from the Fund only after a faculty practice plan, a physician practice, a trauma center on behalf of a trauma physician or trauma health care practitioner, an individual trauma physician or an individual trauma health care practitioner has completed its collection efforts using the respective entity's documented policies and procedures.</text> </paragraph> <paragraph num="H."> <text>Order of Preference.</text> <paragraph num="(1)"> <text>To minimize administrative costs in administering the Fund, the order of preference for the entity submitting an uncompensated services claim is as follows:</text> <paragraph num="(a)"> <text>Faculty practice plan;</text> </paragraph> <paragraph num="(b)"> <text>Physician practice;</text> </paragraph> <paragraph num="(c)"> <text>Trauma physician;</text> </paragraph> <paragraph num="(d)"> <text>Individual trauma health care practitioner.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The preference specified in §H(1) of this regulation refers to the submitting entity and not the preference for distributing payments.</text> </paragraph> </paragraph> <paragraph num="I."> <text>A trauma patient treated at an out-of-State pediatric trauma center that has entered into an agreement with MIEMSS shall be a Maryland resident in order for the trauma physician or trauma health care practitioner to file an uncompensated services application for an uncompensated care shortfall payment. The determination of whether a trauma patient is a Maryland resident shall be based on the trauma patient's demographic information as listed on the Maryland Trauma Registry.</text> </paragraph> <paragraph num="J."> <text>The uncompensated services claim shall contain the following information:</text> <paragraph num="(1)"> <text>The name and federal tax identification number of the trauma physician or trauma health care practitioner rendering the care;</text> </paragraph> <paragraph num="(2)"> <text>The date of the service;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate codes describing the service;</text> </paragraph> <paragraph num="(4)"> <text>Any amount recovered for the service rendered;</text> </paragraph> <paragraph num="(5)"> <text>The name of the trauma patient;</text> </paragraph> <paragraph num="(6)"> <text>The trauma patient's Maryland Trauma Registry number;</text> </paragraph> <paragraph num="(7)"> <text>Date of the original trauma injury;</text> </paragraph> <paragraph num="(8)"> <text>The diagnosis codes that were treated;</text> </paragraph> <paragraph num="(9)"> <text>The procedure and service codes performed; and</text> </paragraph> <paragraph num="(10)"> <text>Other information requested in the claim.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Commission, in consultation with the Health Services Cost Review Commission, may establish a payment rate for uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to trauma patients that is above the 100 percent of Medicare payment for the service if:</text> <paragraph num="(1)"> <text>The Commission determines that increasing the payment rate above 100 percent of the Medicare payment for the service will address an unmet need in the State trauma system;</text> </paragraph> <paragraph num="(2)"> <text>The source of revenue increases and the projected current uses of the Fund decline;</text> </paragraph> <paragraph num="(3)"> <text>The Commission considers data analyses of trauma care rendered at Maryland trauma centers for CPT codes reimbursed as uncompensated care as reported to the Maryland Medical Care Data Base; and</text> </paragraph> <paragraph num="(4)"> <text>The Commission reports on its intention to increase the payment rate to the Senate Finance Committee and the House Health and Government Operations Committee, at least 60 days before any adjustment to the rate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="On-Call Payment."> <paragraph num="A."> <text>Eligibility. The Fund will reimburse trauma centers' on-call costs to maintain surgeons on-call in conformance with MIEMSS' regulations at COMAR 30.08.05 — 30.08.14 for the minimum number of trauma physicians required to be on-call. Trauma centers are eligible for on-call payments as follows:</text> <paragraph num="(1)"> <text>The Level I trauma center and pediatric trauma center are eligible for on-call payments for on-call hours provided by trauma specialties designated in §B of this regulation on or after July 1, 2024;</text> </paragraph> <paragraph num="(2)"> <text>Level II trauma centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §C of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Level III trauma centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §D of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Specialty Referral Centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §E of this regulation on or after July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To determine the amount of on-call payments to a Level I trauma center or pediatric trauma center from the Fund, the following apply:</text> <paragraph num="(1)"> <text>The cost incurred by a Level I trauma center or pediatric trauma center to maintain trauma surgeons, pediatric trauma surgeons, neurosurgeons, and orthopedic surgeons on-call when a post-graduate resident, who meets MIEMMS’ requirements under COMAR 30.08.05.07, is attending shall be reimbursed at the lesser of a trauma center's actual on-call costs, or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(2)"> <text>A Level I trauma center shall be eligible for a maximum 4,380 on-call hours each fiscal year beginning July 1, 2024; and</text> </paragraph> <paragraph num="(3)"> <text>A pediatric trauma center shall be eligible for a maximum 4,380 on-call hours each fiscal year beginning July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To determine the amount of on-call payments to a Level II trauma center from the Fund, the following apply:</text> <paragraph num="(1)"> <text>The cost incurred by a Level II trauma center to maintain trauma surgeons, neurosurgeons, and orthopedic surgeons on-call shall be reimbursed at the lesser of a trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; and</text> </paragraph> <paragraph num="(2)"> <text>A Level II trauma center shall be eligible for a maximum 26,280 on-call hours each fiscal year beginning July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To determine the amount of on-call payments to a Level III trauma center from the Fund, the following apply:</text> <paragraph num="(1)"> <text>The cost incurred by a Level III trauma center to maintain anesthesiologists, neurosurgeons, orthopedic surgeons, and trauma surgeons on-call shall be reimbursed at the lesser of a trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalents hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(2)"> <text>A Level III trauma center shall be eligible for a maximum 35,040 on-call hours each fiscal year beginning July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="E."> <text>To determine the amount of on-call payments to a Specialty Referral Center from the Fund, the following apply:</text> <paragraph num="(1)"> <text>The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Johns Hopkins Health System Burn Program shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(2)"> <text>The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Eye Trauma Center at the Wilmer Eye Institute at The Johns Hopkins Hospital, the cost incurred to maintain ophthalmologists on-call shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(3)"> <text>The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Curtis National Hand Center at Union Memorial Hospital, shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; and</text> </paragraph> <paragraph num="(4)"> <text>A Specialty Referral Center trauma center shall be eligible for a maximum 2,190 hours of trauma on-call per fiscal year, beginning July 1, 2024.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The trauma center shall apply for payment from the Fund by submitting a semiannual on-call services application within 30 days after the end of the reporting cycle.</text> </paragraph> <paragraph num="G."> <text>The on-call services application shall list on-call costs paid to trauma physicians at the trauma center during the reporting cycle. The on-call services application shall contain the following information:</text> <paragraph num="(1)"> <text>The name and trauma level of the trauma center;</text> </paragraph> <paragraph num="(2)"> <text>The name of each trauma physician providing on-call coverage;</text> </paragraph> <paragraph num="(3)"> <text>The specialty of each trauma physician providing on-call coverage;</text> </paragraph> <paragraph num="(4)"> <text>The amount of time available on-call for each physician;</text> </paragraph> <paragraph num="(5)"> <text>The amount paid in on-call stipends to each physician; and</text> </paragraph> <paragraph num="(6)"> <text>Any other information required by the Commission to validate the claim.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Commission may increase the hours and percent of RCE specified in this regulation in accordance with Health General § 19-130, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Payment for Costs at a Pediatric Center."> <paragraph num="A."> <text>The pediatric trauma centers listed below shall be eligible for an annual grant of up to $900,000 for documented expenses related to the provision of trauma care to Maryland residents:</text> <paragraph num="(1)"> <text>Johns Hopkins Children’s Center; and</text> </paragraph> <paragraph num="(2)"> <text>Children’s National Medical Center.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pediatric trauma centers shall submit an application for documented expenses incurred in the previous fiscal year using guidelines developed by the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="C."> <text>The pediatric trauma center shall submit the application for its previous fiscal year to the Commission within 45 days after the end of that fiscal year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Trauma Equipment Grants."> <paragraph num="A."> <text>Eligibility.</text> <paragraph num="(1)"> <text>The Commission, in consultation with the Health Services Cost Review Commission and the Maryland Institute for Emergency Medical Services Systems, shall develop a process for the award of grants to Level I, Level II and Level III trauma centers to be used in the delivery of trauma care.</text> </paragraph> <paragraph num="(2)"> <text>The process developed by the Commission for the award of grants shall include:</text> <paragraph num="(a)"> <text>Grant applications and review and selection criteria for the award of grants;</text> </paragraph> <paragraph num="(b)"> <text>Review by the Commission, if necessary, for any project that exceeds Certificate of Need thresholds; and</text> </paragraph> <paragraph num="(c)"> <text>Any other procedure determined necessary by the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission may issue grants from any balance carried over to the Fund from prior fiscal years.</text> </paragraph> <paragraph num="C."> <text>The total amount of grants awarded in a fiscal year may not reduce the balance remaining in the Fund at the end of the fiscal year to less than 15 percent of the revenue collected in that fiscal year.</text> </paragraph> <paragraph num="D."> <text>Before awarding grants under this regulation in a fiscal year, the Commission shall report to the Senate Finance Committee and the House Health and Government Operations Committee on the process that the Commission has developed for awarding grants in that fiscal year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Equitable Payment Under the Fund."> <paragraph num="A."> <text>Disbursement from the Fund is subject to the availability of funds.</text> </paragraph> <paragraph num="B."> <text>The Commission shall adjust reimbursement formulas used for Medicaid trauma services, uncompensated care trauma services, on-call payments, and standby payments to a pediatric trauma center to preserve the distribution of monies in the Fund.</text> </paragraph> <paragraph num="C."> <text>Revenue; Payments.</text> <paragraph num="(1)"> <text>On or before May 1 of each year, the Commission shall determine appropriate levels of payment that can be sustained for the upcoming fiscal year beginning July 1, given the expected revenue in the Fund.</text> </paragraph> <paragraph num="(2)"> <text>If expected revenue in the Fund is insufficient to meet expected payments, the Medicaid differential payments, uncompensated care shortfall payments, trauma center on-call payments, and standby payments to a pediatric trauma center shall be adjusted by the same rate to maintain solvency in the Fund.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall maintain a sufficient balance in the Fund to assure equitable payments across a fiscal year.</text> </paragraph> <paragraph num="(4)"> <text>If Fund payments require adjustment, the Commission shall report to the trauma centers and the trauma physicians listed on trauma center rosters the expected payment levels for the upcoming State fiscal year by June 30.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Commission estimates that operating shortfalls will occur during a fiscal year and that those shortfalls will be sufficiently large that the annual update process cannot be used, the Commission shall use the following conventions:</text> <paragraph num="(1)"> <text>On-call payments for the next semiannual reporting period shall be adjusted to preserve solvency in the Fund;</text> </paragraph> <paragraph num="(2)"> <text>Priority for meeting the funding needs of Level III trauma centers to maintain physicians shall be maintained;</text> </paragraph> <paragraph num="(3)"> <text>The Commission may not change Medicaid reimbursement during a fiscal year, unless a 4-month notice is provided to the Medicaid program and the uncompensated care and on-call payments have already been halted; and</text> </paragraph> <paragraph num="(4)"> <text>The Commission shall adjust Medicaid reimbursements during subsequent annual update processes to adjust for any inequities that arise due to implementation of §D(3) of this regulation during the preceding fiscal year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Filing of On-call Applications and Uncompensated Care Claims."> <paragraph num="A."> <text>In order to receive a payment from the Fund for uncompensated care, a faculty practice plan, a physician practice, a trauma physician, a trauma health care practitioner, or a trauma center on behalf of a trauma physician or trauma health care practitioner shall submit a timely and complete uncompensated services claim that includes the information required in this chapter on a form and in a manner approved by the Commission as indicated in the application.</text> </paragraph> <paragraph num="B."> <text>In order to receive a payment from the Fund for on-call costs, a faculty practice plan, a physician practice, a trauma physician, or a trauma center on behalf of a trauma physician, shall submit a timely and complete on-call services application that includes the information required in this chapter on a form and in a manner approved by the Commission as indicated in the application.</text> </paragraph> <paragraph num="C."> <text>A faculty practice plan, a physician practice plan, a trauma center, or a trauma physician that does not file an on-call services application within the time frame specified is not eligible for participation in the Fund for that time period.</text> </paragraph> <paragraph num="D."> <text>An on-call services application that is substantially incomplete or inaccurate may be considered not filed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Audits."> <paragraph num="A."> <text>The Commission, or its designee, may audit to verify the information submitted by faculty practice plans, physician practices, trauma physicians, trauma health care practitioners, and trauma centers applying for grants or reimbursement from the Fund.</text> </paragraph> <paragraph num="B."> <text>The Commission, or its designee, may perform on-site audits.</text> </paragraph> <paragraph num="C."> <text>A person who has submitted an application for a grant or reimbursement from the Fund shall provide the Commission, or its designee, with access to all information, documents, and facilities requested by the Commission, or its designee, for purposes of auditing the person’s application.</text> </paragraph> <paragraph num="D."> <text>Information discovered by the audit process indicating that an application for payment from the Fund was improperly paid may result in remedial action being taken, including but not limited to, denial or partial denial of future payments from the Fund, referral to the State of Maryland, Central Collections Unit, or other appropriate action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Appeals."> <paragraph num="A."> <text>The Commission's executive director, or designee, shall review any appeal from an audit finding, a denial, or partial denial, of an uncompensated care shortfall payment, an on-call payment or grant award.</text> </paragraph> <paragraph num="B."> <text>To secure review of an audit finding, denial, or partial denial, an applicant shall file a written appeal of the denial with the Commission, together with any supporting memoranda and documentation, within 15 days of the date of receipt of audit finding, the denial, or the partial denial, from the Fund.</text> </paragraph> <paragraph num="C."> <text>In reviewing an audit finding, a denial, or a partial denial, of an uncompensated care shortfall payment, on-call payment or grant award, the executive director, or designee, shall consider all relevant factors and render a decision upon the written information, without an oral hearing, in a timely fashion. The executive director, or designee, may seek and consider further information from the applicant or supplementation of the application, if necessary or appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Annual Reconciliation Reporting Requirements."> <paragraph num="A."> <text>On or before January 31 of each year, a trauma physician or trauma health care practitioner who has received uncompensated care reimbursement from the Fund during the prior calendar year shall file an annual reconciliation report with the Commission.</text> </paragraph> <paragraph num="B."> <text>The annual reconciliation report shall include:</text> <paragraph num="(1)"> <text>The name, address, and telephone number of the practitioner, practice, or center;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and telephone number of the practitioner, practice, or center's contact person for the report;</text> </paragraph> <paragraph num="(3)"> <text>The name of the trauma center where care was provided;</text> </paragraph> <paragraph num="(4)"> <text>The amount of money recovered from another payer source for claims that had been reimbursed by the Fund, including:</text> <paragraph num="(a)"> <text>The practitioner's name providing the care;</text> </paragraph> <paragraph num="(b)"> <text>The patient's name, Trauma Registry number, Social Security number, dates of service, and total amount paid by the Trauma Fund;</text> </paragraph> <paragraph num="(c)"> <text>The source of the additional funds received;</text> </paragraph> <paragraph num="(d)"> <text>The amount of the other payment received; and</text> </paragraph> <paragraph num="(e)"> <text>The amount returned to the Trauma Fund; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A certification by an authorized designee of the practitioner, practice, or center that the facts stated in the annual reconciliation report are true and accurate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Prohibited Acts."> <paragraph num="A."> <text>An applicant for payment from the Fund may not:</text> <paragraph num="(1)"> <text>Make, or cause to be made, a false statement or false claim; or</text> </paragraph> <paragraph num="(2)"> <text>Engage in fraud in submitting a claim or application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Violation of §A of this regulation may result in:</text> <paragraph num="(1)"> <text>Referral to the appropriate Medicaid fraud administrative and prosecutorial authorities, to the Office of the State's Attorney, or both;</text> </paragraph> <paragraph num="(2)"> <text>Rescission of, or an action for recovery of, any prior reimbursement improperly made by the Fund; and</text> </paragraph> <paragraph num="(3)"> <text>Any other appropriate referrals or administrative action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Reporting Requirements to the General Assembly."> <text>On or before November 1 of each year, the Commission and the HSCRC shall report to the General Assembly in accordance with Health-General Article, §19-130(f) and State Government Article, §2-1246, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Expiration of Fund."> <paragraph num="A."> <text>This chapter remains in effect unless the Fund ceases to be funded or expires by operation of law.</text> </paragraph> <paragraph num="B."> <text>In the event the Fund ceases to operate, unless otherwise provided by law, the Fund shall make any final disbursements for the current reporting period based upon available funds.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Effective Date."> <text>Trauma services provided by a trauma health care practitioner to a trauma patient on or after July 1, 2024, are eligible for reimbursement pursuant to the provisions set forth in this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-103(c), 19-130, and 19-207, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 adopted as an emergency provision effective July 1, 2003 (30:19 Md. R. 1327); adopted permanently effective December 22, 2003 (30:25 Md. R. 1846)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 repealed and new regulations .01 — .17 adopted as an emergency provision effective July 1, 2006 (33:21 Md. R. 1672); adopted permanently effective October 23, 2006 (33:21 Md. R. 1676)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .17 repealed and new regulations .01—.19 adopted effective June 15, 2009 (36:12 Md. R. 837)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B, C amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, C amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16B amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective January 20, 2025 (52:1 Md. R. 18)</annotation> </annotations> </chapter> <chapter num="11" heading="Institutional Review Board"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter provides one method by which the Commission may consider requests for encounter level data from the Maryland medical care data base and any other Commission data base that contains data elements that qualify as “individually identifiable health information”, as defined in the Health Insurance Portability and Accountability Act of 1996, P.L. 104-191 (1996). The Commission may also use another recognized Institutional Review Board to consider requests for encounter level data from the Maryland medical care data base or any other requests for Commission information that require consideration by an Institutional Review Board.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>Requests for information from the Maryland medical care data base or any other Commission data base considered public under applicable laws and regulations; or</text> </paragraph> <paragraph num="(2)"> <text>Internal activities of the Commission that are required for it to conduct its lawful business of assembling the Maryland medical care data base, or any other data base that it is authorized to create, and performing research.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Application” means a request for information made pursuant to this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Maryland Health Care Access and Cost Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Data base” means the Maryland medical care data base established at Health-General Article, §19-1507, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“IRB” means the Institutional Review Board.</text> </paragraph> <paragraph num="(5)"> <text>“Personal records” has the meaning set forth in State Government Article, §10-624, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="IRB Membership."> <paragraph num="A."> <text>The Commission shall appoint the IRB.</text> </paragraph> <paragraph num="B."> <text>The IRB shall consist of at least nine members of which:</text> <paragraph num="(1)"> <text>Each member shall have expertise in health services research and information security; and</text> </paragraph> <paragraph num="(2)"> <text>At least one member's primary expertise is ethics.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The IRB shall be sufficiently qualified through the experience and diversity of its members, including consideration of race, gender, and cultural backgrounds, and sensitivity to such issues as community attitudes to promote respect for its advice and counsel.</text> </paragraph> <paragraph num="D."> <text>Commission members and Commission staff may not serve on the IRB. Commission staff may provide staff support to the IRB.</text> </paragraph> <paragraph num="E."> <text>The Commission shall solicit recommendations for appointment to the IRB from organizations and institutions whose mission is related to IRB matters, as the Commission considers appropriate.</text> </paragraph> <paragraph num="F."> <text>Members shall serve on a volunteer basis for a term not to exceed 3 years. A member may be reappointed.</text> </paragraph> <paragraph num="G."> <text>The Commission may remove a member for:</text> <paragraph num="(1)"> <text>Misconduct; or</text> </paragraph> <paragraph num="(2)"> <text>Dereliction of duty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="IRB Review of Applications."> <paragraph num="A."> <text>The IRB shall review all applications submitted pursuant to this chapter.</text> </paragraph> <paragraph num="B."> <text>The IRB shall recommend:</text> <paragraph num="(1)"> <text>Approval, disapproval, or termination; or</text> </paragraph> <paragraph num="(2)"> <text>Modifications in research or security to secure approval.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The IRB shall meet as necessary in order to provide timely responses to requests for information.</text> </paragraph> <paragraph num="D."> <text>Requests for information within the scope of this chapter shall include a description of the:</text> <paragraph num="(1)"> <text>Research use to be made of the information;</text> </paragraph> <paragraph num="(2)"> <text>Intent, if any, to present or publish the findings;</text> </paragraph> <paragraph num="(3)"> <text>Nature of the requested information;</text> </paragraph> <paragraph num="(4)"> <text>Safeguards and procedures that the applicant will take to protect the identity of the data; and</text> </paragraph> <paragraph num="(5)"> <text>A description of any potential risks or benefits.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Upon receipt of an application within the scope of this chapter, the Commission shall immediately forward the request and all supporting documentation to the IRB for a recommendation.</text> </paragraph> <paragraph num="F."> <text>The IRB shall require an applicant to provide any:</text> <paragraph num="(1)"> <text>Documentation necessary to satisfy itself that the security of the released data will be preserved; and</text> </paragraph> <paragraph num="(2)"> <text>Information necessary to assist the IRB in making a decision on an application.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The IRB shall make a timely recommendation concerning release of the requested information.</text> </paragraph> <paragraph num="H."> <text>An IRB recommendation shall be made on the basis of a majority of the full IRB membership.</text> </paragraph> <paragraph num="I."> <text>If the IRB denies an application, the IRB shall inform the applicant promptly in writing of the reasons for denial.</text> </paragraph> <paragraph num="J."> <text>Deliberations.</text> <paragraph num="(1)"> <text>In conducting its deliberations, the IRB shall be mindful of conflicts of interest and the appearance of conflict.</text> </paragraph> <paragraph num="(2)"> <text>IRB members with an actual or apparent conflict concerning a particular application shall recuse themselves from deliberating and voting upon that application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Criteria for Approval."> <text>The IRB shall recommend approval of an application only if:</text> <paragraph num="A."> <text>It is satisfied that:</text> <paragraph num="(1)"> <text>The use proposed to be made of the requested information is in the public interest,</text> </paragraph> <paragraph num="(2)"> <text>The risks of release of the requested information are reasonable in relation to the anticipated benefits, and</text> </paragraph> <paragraph num="(3)"> <text>Safeguards adequate to prevent inappropriate disclosures will be implemented by the applicant; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant agrees to comply with the requirements of Regulation .12 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Commission Review of IRB Recommendations."> <paragraph num="A."> <text>The Commission shall review:</text> <paragraph num="(1)"> <text>All IRB recommendations for approval of applications; and</text> </paragraph> <paragraph num="(2)"> <text>IRB denials of applications only for good cause shown by the applicant, which shall consist of evidence demonstrating that the IRB failed to follow the process set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to secure Commission review of an IRB denial, an applicant shall file an appeal of the denial with the Commission, together with any supporting memoranda and documentation, within 15 days of the date of receipt of the IRB denial.</text> </paragraph> <paragraph num="C."> <text>In reviewing an IRB recommendation, the Commission shall consider all relevant factors and render its decision in a timely fashion. In reviewing an IRB recommendation to deny an application, the Commission shall affirm the IRB's decision or, if the evidence warrants, remand the case to the IRB for further consideration. In remanding the matter to the IRB, the Commission shall inform the IRB of the basis for its decision and instruct the IRB concerning any remedial measures which the IRB must take on remand.</text> </paragraph> <paragraph num="D."> <text>A request for data from the data base is not a contested case under the Administrative Procedure Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Expedited Review Procedures."> <paragraph num="A."> <text>The IRB may use an expedited review procedure to review applications relating to minor changes to already approved information requests.</text> </paragraph> <paragraph num="B."> <text>Under an expedited review procedure, the review shall be carried out by:</text> <paragraph num="(1)"> <text>The chairperson of the IRB; or</text> </paragraph> <paragraph num="(2)"> <text>An IRB member designated by the chairperson.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In reviewing the application under an expedited process, the reviewer shall exercise all of the authority of the IRB, except that the reviewer may not disapprove an application.</text> </paragraph> <paragraph num="D."> <text>An application shall be disapproved only after review in accordance with the nonexpedited procedure set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Under an expedited review, Commission approval of an IRB recommendation shall be made only by vote of a majority of the full Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Suspension or Termination of IRB Approval."> <paragraph num="A."> <text>The Commission shall require an applicant to file periodic progress reports concerning any aspect of the use of data released under this chapter.</text> </paragraph> <paragraph num="B."> <text>The Commission may:</text> <paragraph num="(1)"> <text>Investigate use made of data released under this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Require an applicant to provide information necessary to assist the Commission in its investigation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission may delegate the function listed in §B of this regulation to the IRB.</text> </paragraph> <paragraph num="D."> <text>If an applicant fails to make use of the data in accordance with IRB requirements, including IRB data security and confidentiality requirements, the Commission, at the recommendation of the IRB or on its own motion, may:</text> <paragraph num="(1)"> <text>Immediately suspend or terminate its approval of the data release; and</text> </paragraph> <paragraph num="(2)"> <text>Require the applicant to:</text> <paragraph num="(a)"> <text>Return to the Commission, or</text> </paragraph> <paragraph num="(b)"> <text>Destroy previously released data.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The applicant is entitled to a post-suspension or termination hearing in front of the IRB to show cause why the suspension or termination should be rescinded. Following the hearing, the IRB shall make a recommendation to the Commission concerning reinstatement of the applicant's use of the information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Cooperative Research Activities."> <text>Data release to a party with which the Commission has contracted pursuant to the State procurement process may not be referred to the IRB. However, other cooperative research activities involving data within the scope of this chapter shall be referred to the IRB for its opinion and recommendation.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="IRB Records."> <paragraph num="A."> <text>The IRB shall maintain the following records:</text> <paragraph num="(1)"> <text>Minutes of all IRB meetings describing:</text> <paragraph num="(a)"> <text>Time and date of the meetings;</text> </paragraph> <paragraph num="(b)"> <text>Members present;</text> </paragraph> <paragraph num="(c)"> <text>Actions taken;</text> </paragraph> <paragraph num="(d)"> <text>Votes on the actions including the number:</text> <paragraph num="(i)"> <text>Voting for;</text> </paragraph> <paragraph num="(ii)"> <text>Voting against; and</text> </paragraph> <paragraph num="(iii)"> <text>Abstaining;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The basis for requiring changes in or disapproving research; and</text> </paragraph> <paragraph num="(f)"> <text>A discussion of controverted issues and their resolution;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Minutes which shall include:</text> <paragraph num="(a)"> <text>Copies of all applications, supporting documentation, related correspondence, and progress reports;</text> </paragraph> <paragraph num="(b)"> <text>Records of continuing review activities;</text> </paragraph> <paragraph num="(c)"> <text>A list of IRB members and current curriculum vitae sufficient to demonstrate the IRB members' areas of expertise and current employment or consultant relationships and board memberships; and</text> </paragraph> <paragraph num="(d)"> <text>Any written procedures or bylaws adopted by the IRB.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The IRB shall adhere to the record retention guidelines applicable to the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Completion of Research Activities."> <text>Upon completion of research conducted with data released under this chapter, the applicant, at the IRB's discretion, shall:</text> <paragraph num="A."> <text>Destroy or return to the Commission all data and copies of data obtained from the Commission; and</text> </paragraph> <paragraph num="B."> <text>Provide to the Commission and the IRB a copy of any report, article, paper, or other document prepared by the applicant with use of the released data.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Contract Provisions and Penalties."> <text>As a prerequisite for release of any information under this chapter, the applicant shall enter into an agreement with the Commission which:</text> <paragraph num="A."> <text>Defines the scope of the use to be made of the released information;</text> </paragraph> <paragraph num="B."> <text>Provides for safeguards for protecting the identity of data;</text> </paragraph> <paragraph num="C."> <text>States that a breach of any condition of the agreement is a breach of contract;</text> </paragraph> <paragraph num="D."> <text>Provides for the return or destruction of data upon a determination of breach of contract by the Commission; and</text> </paragraph> <paragraph num="E."> <text>Authorizes the Commission to seek all other appropriate remedies for breach of contract.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (7) and (b)(5), 19-103(c)(3), and 19-133(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 8, 1999 (26:5 Md. R. 391)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 14, 2002 (29:20 Md. R. 1589)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective August 22, 2011 (38:17 Md. R. 1013)</annotation> </annotations> </chapter> <chapter num="12" heading="Imposition of Fines"> <regulation prefix="Regulation" num=".01" heading="Assessment of Fines."> <paragraph num="A."> <text>Except as provided in §B of this regulation and unless the Executive Director or the Executive Director's designee has granted an extension of time, a party that fails to timely file a report or other information required by the Commission may be liable for a monetary penalty, not to exceed $1,000 per day, for each day the filing of the report is past due.</text> </paragraph> <paragraph num="B."> <text>For information required by the Commission pursuant to Health-General Article, §19-116(b), Annotated Code of Maryland, and unless the Executive Director or the Executive Director's designee has granted an extension of time, a party that fails to timely file a report or other information required by the Commission may be liable for a monetary penalty, not to exceed $100 per day, for each day the filing of the report is past due.</text> </paragraph> <paragraph num="C."> <text>A data report that is substantially incomplete or inaccurate is not timely filed.</text> </paragraph> <paragraph num="D."> <text>The filing of a written petition for review of a denial of an extension of time stays the accrual of the monetary penalty levied under §§A and B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Process for Levying and Appealing an Assessment."> <paragraph num="A."> <text>The Executive Director shall determine the amount assessed pursuant to this chapter by considering the factors set forth in Regulation .03.</text> </paragraph> <paragraph num="B."> <text>The Executive Director shall issue a notice of assessment to a party found to have filed untimely or inaccurate information, explaining the basis for the assessment.</text> </paragraph> <paragraph num="C."> <text>A party assessed a fine has 10 business days from the date of receipt of the assessment to appeal the assessment to the Commission.</text> </paragraph> <paragraph num="D."> <text>Upon receipt of an appeal, the Chairman of the Commission may:</text> <paragraph num="(1)"> <text>Schedule a date for hearing the appeal before the full Commission; or</text> </paragraph> <paragraph num="(2)"> <text>Appoint a commissioner to act as a hearing officer.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Commission staff may participate in the hearing.</text> </paragraph> <paragraph num="F."> <text>If the Chairman appoints a commissioner as a hearing officer, the hearing officer shall issue a proposed decision containing proposed findings of fact and conclusions of law.</text> </paragraph> <paragraph num="G."> <text>Parties may file exceptions to the hearing officer's proposed decision with the full Commission.</text> </paragraph> <paragraph num="H."> <text>Exceptions shall identify specific aspects of the proposed decision with which the excepting party disagrees and explain the basis of the disagreement with specific citation to the record or applicable law.</text> </paragraph> <paragraph num="I."> <text>The full Commission shall entertain oral argument on exceptions and issue a final decision.</text> </paragraph> <paragraph num="J."> <text>All hearings shall be conducted in accordance with the procedural requirements of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Factors Considered in the Assessment of Penalties."> <paragraph num="A."> <text>The Commission shall consider the following factors in determining whether to impose a fine and the amount of any fine:</text> <paragraph num="(1)"> <text>The willfulness of the improper conduct;</text> </paragraph> <paragraph num="(2)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(3)"> <text>The cost of auditing or investigating the matter; and</text> </paragraph> <paragraph num="(4)"> <text>The party's history of any previous violation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission may suspend or waive any fine for reporting of inaccurate data if the party that filed the inaccurate data reports and corrects the inaccuracies in a timely manner.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-109(a)(1) and (7)and 19-116(b)(1) and (2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 23, 2002 (29:25 Md. R. 1984)</annotation> </annotations> </chapter> <chapter num="13" heading="Health Information Technology Funding Applications"> <regulation prefix="Regulation" num=".01" heading="Applicability."> <text>This chapter applies to the consideration, by the Maryland Health Care Commission, of an application seeking approval for funding that is responsive to an announcement posted by the Maryland Health Care Commission that it will accept applications regarding one or more specified areas of health information technology.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a person, partnership, firm, association, institution, limited liability company, limited liability partnership, public or private corporation or agency, and shall include at least one rate-regulated hospital, or combination of them.</text> </paragraph> <paragraph num="(2)"> <text>“Approval for funding” means a determination made by the Health Services Cost Review Commission that it will approve an adjustment to hospital rates based on review of an application and recommendation for funding made by the Maryland Health Care Commission for an activity or program proposed by an applicant.</text> </paragraph> <paragraph num="(3)"> <text>“Maryland Health Care Commission (MHCC)” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Health Services Cost Review Commission (HSCRC)” means the agency established by Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notice of Acceptance of Applications for Funding for Health Information Technology Initiative."> <text>The Maryland Health Care Commission shall inform potential applicants that it will accept applications seeking approval for funding regarding one or more specified areas of health information technology, by posting an announcement on the MHCC website that includes, but is not limited to, the following:</text> <paragraph num="A."> <text>Each specific topic to be addressed;</text> </paragraph> <paragraph num="B."> <text>Required elements;</text> </paragraph> <paragraph num="C."> <text>Application deadline;</text> </paragraph> <paragraph num="D."> <text>Application review criteria;</text> </paragraph> <paragraph num="E."> <text>Method of review;</text> </paragraph> <paragraph num="F."> <text>Available funding for each application; and</text> </paragraph> <paragraph num="G."> <text>The maximum number of applications for which funding will be recommended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Review of Applications."> <paragraph num="A."> <text>The executive director of the Maryland Health Care Commission:</text> <paragraph num="(1)"> <text>Shall review each application submitted pursuant to this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>May seek the assistance of others in the review.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The executive director shall forward the results of the review to the Maryland Health Care Commission for its consideration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="MHCC Recommendation to the HSCRC; Action by the HSCRC."> <paragraph num="A."> <text>The Maryland Health Care Commission shall:</text> <paragraph num="(1)"> <text>Determine which applications merit consideration of approval for funding by the Health Services Cost Review Commission; and</text> </paragraph> <paragraph num="(2)"> <text>For each application recommended for consideration, send to the HSCRC appropriate information that may include the following:</text> <paragraph num="(a)"> <text>A summary of the review criteria and scoring for each recommended application; and</text> </paragraph> <paragraph num="(b)"> <text>A recommended priority order for funding.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Health Services Cost Review Commission shall make the final decision on each MHCC-recommended application approved for funding.</text> </paragraph> <paragraph num="C."> <text>Any funding approved by the HSCRC shall be implemented through reasonable rate adjustments as determined by the HSCRC.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-103(c)(2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 18, 2006 (33:25 Md. R. 1951)</annotation> </annotations> </chapter> <chapter num="14" heading="Health Care Data Collection from Maryland Health Care Practitioners"> <regulation prefix="Regulation" num=".01" heading="Applicability."> <text>This chapter applies to the collection of health care data, by the Maryland Health Care Commission, from health care practitioners in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Health care” means any care treatment, or procedure by a healthcare practitioner:</text> <paragraph num="(a)"> <text>To diagnose, evaluate, rehabilitate, manage, treat, or maintain the physical or mental condition of a patient; or</text> </paragraph> <paragraph num="(b)"> <text>That affects the structure or any function of the human body.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Health care practitioner” means an individual who is licensed or certified under the Health Occupations Article to provide health care in the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Information to be Collected."> <text>The Commission may collect the following data from a health care practitioner:</text> <paragraph num="A."> <text>Data that indicate the nature of the health care practice in which the health care practitioner is engaged;</text> </paragraph> <paragraph num="B."> <text>Data that indicate whether the health care practitioner is actively engaged in the practice of health care;</text> </paragraph> <paragraph num="C."> <text>Data that indicate whether the health care practitioner is currently engaged in direct patient care in the State;</text> </paragraph> <paragraph num="D."> <text>Data that indicate the health care practitioner's primary language, race, and ethnicity;</text> </paragraph> <paragraph num="E."> <text>Data that describe the health care practitioner's areas of specialty, including:</text> <paragraph num="(1)"> <text>Specialty qualifications or training;</text> </paragraph> <paragraph num="(2)"> <text>Specialty certification, licensure, or status; and</text> </paragraph> <paragraph num="(3)"> <text>Current areas of concentration;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Data that identify the number and location of a health care practitioner's practice locations;</text> </paragraph> <paragraph num="G."> <text>Data that indicate whether the health care practitioner provides primary or preventive care services, or both, in Maryland;</text> </paragraph> <paragraph num="H."> <text>Data that indicate the nature and extent of the practitioner's use of information technology in the diagnosis and treatment of patients;</text> </paragraph> <paragraph num="I."> <text>Data that indicate whether the health care practitioner accepts or treats patients who are covered by Maryland Medical Assistance or Medicare; and</text> </paragraph> <paragraph num="J."> <text>Data that indicate whether the health care practitioner provides care to low-income patients and, if so, the nature of the compensation received for that care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Confidentiality of Information Collected."> <text>Information collected by the Commission that is required by law to be held confidential may not be disclosed by the Commission to other persons or entities.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-133(b) and (d)(1), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 17, 2008 (35:23 Md. R. 2013)</annotation> </annotations> </chapter> <chapter num="15" heading="Management Service Organization State Designation"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the State designation of management service organizations. Only a management service organization that is awarded State Designation status by the Maryland Health Care Commission pursuant to this chapter may represent itself as a State-Designated management service organization.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” or “MHCC” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“Electronic health record” or “EHR” means a complete electronic record system that:</text> <paragraph num="(a)"> <text>Contains health-related information on one or more individuals; and</text> </paragraph> <paragraph num="(b)"> <text>Is certified by an authorized testing and certification body designated by the Office of the National Coordinator for Health Information Technology.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Entity” means an individual, trust or estate, general or limited partnership, joint stock company, unincorporated association or society, municipal or other corporation, incorporated association, limited liability partnership, limited liability company, the State, an agency or political subdivision of the State, a court, and any other governmental body.</text> </paragraph> <paragraph num="(4)"> <text>“Executive Director” means the Executive Director of the Commission.</text> </paragraph> <paragraph num="(5)"> <text>“Management service organization” or “MSO” means an entity that provides technology and consultative services to health care providers, and makes available one or more hosted electronic health records systems and other health information technology solutions.</text> </paragraph> <paragraph num="(6)"> <text>“MSO State Designation certificate” means a certificate provided to the MSO by the Commission that documents award of State Designation.</text> </paragraph> <paragraph num="(7)"> <text>“MSO State Designation criteria” means the standards published by the Commission on its website and by notice in the Maryland Register that an MSO must meet to qualify for State Designation.</text> </paragraph> <paragraph num="(8)"> <text>“State Designation” or “State-Designated” means the status awarded by the Commission to an MSO that has met the MSO State Designation criteria required under this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Procedure for Initial State Designation."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>An entity seeking MSO State Designation shall submit an application in a form and manner specified by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The application shall be signed by an individual authorized by the entity submitting the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements for State Designation. An applicant for MSO State Designation shall:</text> <paragraph num="(1)"> <text>Demonstrate that it meets all MSO State Designation criteria in effect at the date of application;</text> </paragraph> <paragraph num="(2)"> <text>Affirm that the applicant, a related entity, or a person or entity that is a principal, owner, operator, or part of management of the entity has never:</text> <paragraph num="(a)"> <text>Pleaded guilty to, been convicted of, or received probation before judgment or similar diversionary disposition for a crime related to the operation of an MSO or for a crime involving fraud, dishonesty, or false dealing; or</text> </paragraph> <paragraph num="(b)"> <text>Been found in violation of State or federal laws or regulations governing the operation of an MSO;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide all required documentation;</text> </paragraph> <paragraph num="(4)"> <text>Timely provide additional information requested by the Commission as needed to complete the application; and</text> </paragraph> <paragraph num="(5)"> <text>Agree to comply with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Review of Applications.</text> <paragraph num="(1)"> <text>Commission staff shall review an application to determine compliance with the State Designation criteria.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director may approve or deny an application for State Designation, as follows:</text> <paragraph num="(a)"> <text>The Executive Director shall award State Designation to an MSO that meets the requirements set forth in this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>If the Executive Director determines that an application should be denied, the Executive Director shall, within 30 days of receipt of a complete application, notify the applicant in writing of the decision, and include the reasons for denial.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Duration of State Designation.</text> <paragraph num="(1)"> <text>State Designation is valid for 2 years from the date of issuance of an MSO State Designation certificate, unless suspended or revoked by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>An MSO awarded State Designation shall accept the designation in writing and agree to the comply with the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedure for Renewal of State Designation."> <paragraph num="A."> <text>An application for renewal of State Designation shall:</text> <paragraph num="(1)"> <text>Be made at least 30 days before the expiration of the State Designation in a form and manner specified by the Commission; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate compliance with the MSO State Designation criteria in effect at the date of application for renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Commission staff shall review a renewal application to determine compliance with the State Designation criteria.</text> </paragraph> <paragraph num="C."> <text>The Executive Director may approve or deny an application for renewal.</text> </paragraph> <paragraph num="D."> <text>The Executive Director shall renew the State Designation of each MSO that meets the requirements set forth in this chapter.</text> </paragraph> <paragraph num="E."> <text>If the Executive Director determines that a renewal application should be denied, the Executive Director shall, within 30 days of receipt of a complete application for renewal, notify the applicant in writing of the decision, supported by reasons for denial.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial of an Initial or Renewal Application."> <paragraph num="A."> <text>An MSO whose initial or renewal application was denied may seek Commission review of the denial.</text> </paragraph> <paragraph num="B."> <text>A written request for Commission review of the denial of an application shall:.</text> <paragraph num="(1)"> <text>Be filed within 20 days of the receipt of the denial;</text> </paragraph> <paragraph num="(2)"> <text>State with particularity the grounds and factual basis for the applicant’s disagreement with the denial; and</text> </paragraph> <paragraph num="(3)"> <text>Be supported by relevant documentation and affidavits.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission may determine whether or not to affirm the denial of the application or approve the application:</text> <paragraph num="(1)"> <text>After considering the written filing by the MSO and any response by Commission staff; or</text> </paragraph> <paragraph num="(2)"> <text>After hearing oral arguments on the written filings by the MSO and staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nontransferability of Designation."> <text>State Designation issued pursuant to this chapter may not be sold, assigned, leased, or transferred in any way.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Closure, Sale, or Transfer of All or Part of a State-Designated MSO."> <paragraph num="A."> <text>At least 60 days before the closure, sale, lease, assignment, or transfer of all or part of a State-Designated MSO to any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the State-Designated MSO shall notify the Commission of the impending closure, sale, lease, assignment, or transfer of the State-Designated MSO and timely provide information required or requested by the Commission.</text> </paragraph> <paragraph num="B."> <text>If all or part of a State-Designated MSO is closed, sold, leased, assigned, or transferred in any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the Commission shall review current State Designation status pursuant to the renewal requirements set forth in Regulation .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Commission Oversight of State-Designated MSOs."> <paragraph num="A."> <text>Commission staff may, on its own initiative or in response to information provided to the Commission, investigate any State-Designated MSO or applicant for State Designation.</text> </paragraph> <paragraph num="B."> <text>Following an investigation, the Executive Director may issue a notice of proposed action, which may include the following:</text> <paragraph num="(1)"> <text>A time-limited opportunity to correct deficiencies identified by the investigation;</text> </paragraph> <paragraph num="(2)"> <text>Suspension of the State Designation of an MSO for a definite period of time after which, depending upon the circumstances of the case and completion of appropriate corrective actions, the MSO may seek reinstatement of its State Designation; or</text> </paragraph> <paragraph num="(3)"> <text>Revocation of State Designation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MSO that receives a notice of proposed action from the Executive Director may request an opportunity to show cause why the proposed action should not be implemented. A written request to show cause shall be filed with the Commission within 20 days of the issuance of the notice of proposed action and shall:</text> <paragraph num="(1)"> <text>State with particularity the grounds and factual basis for the applicant’s disagreement with the denial;</text> </paragraph> <paragraph num="(2)"> <text>Include each fact upon which the person relies to show cause why the proposed action should not be taken; and</text> </paragraph> <paragraph num="(3)"> <text>Be supported by relevant documentation and affidavits.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Commission may determine whether or not to impose the proposed action or a different action:</text> <paragraph num="(1)"> <text>After considering the written show cause filing by the MSO and any response by Commission staff; or</text> </paragraph> <paragraph num="(2)"> <text>After hearing oral arguments on the written filings by the MSO and staff.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-302, 19-103(c)(2)(i) and (ii), 19-109(a)(1), 19-135(a), (b), and (d), and 19-143(h), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 15, 2010 (37:23 Md. R. 1610)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .11 repealed and new Regulations .01 — .08 adopted effective August 18, 2014 (41:16 Md. R. 946)</annotation> </annotations> </chapter> <chapter num="16" heading="Electronic Health Record Incentives"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to each payor that is required to provide an incentive payment to each primary care practice, including a practice owned by a hospital, that adopts and reaches an approved level of use of electronic health records.</text> </paragraph> <paragraph num="B."> <text>Only a primary care practice that meets the requirements established in this chapter may receive an adoption incentive for electronic health record adoption under this program.</text> </paragraph> <paragraph num="C."> <text>Adoption incentives under this chapter are available through December 31, 2018.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Achieved NCQA level two recognition” means a primary care practice has received recognition from NCQA for meeting NCQA’s 2011 or later standards for a level two patient-centered medical home.</text> </paragraph> <paragraph num="(2)"> <text>“Attested to meaningful use” means a physician or nurse practitioner within a primary care practice has achieved the meaningful use requirements under either the Medicaid or Medicare EHR Incentive Program and has received confirmation of the attestation from:</text> <paragraph num="(a)"> <text>The Centers for Medicare and Medicaid Services; or</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Medical Assistance Program (Medicaid).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“EHR adoption incentive” means a payment that an eligible primary care practice can receive from a payor to assist the primary care practice in adopting an electronic health record and attaining a required use level that:</text> <paragraph num="(a)"> <text>Consists of a one-time cash payment not to exceed $15,000 or an incentive of equivalent value agreed upon by the primary care practice and payor; and</text> </paragraph> <paragraph num="(b)"> <text>Is based on a $25 per-patient payment applied to the total number of patients on the practice panel who are Maryland residents.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Electronic health record” or “EHR” means a complete electronic record system that is certified by an authorized testing and certification body designated by the Office of the National Coordinator for Health Information Technology and that contains health-related information on an individual.</text> </paragraph> <paragraph num="(5)"> <text>Fully Insured Health Benefit Plan.</text> <paragraph num="(a)"> <text>“Fully insured health benefit plan” means a medical policy, contract, or certificate for which an:</text> <paragraph num="(i)"> <text>Employer pays a per-employee premium to a payor and the payor assumes the risk of providing health coverage for insured events and incurred administrative costs; or</text> </paragraph> <paragraph num="(ii)"> <text>Individual pays a premium to a payor.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Fully insured health benefit plan” does not include a self-insured health plan or a health plan for which a payor is acting only as a third-party administrator.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Health Care Provider.</text> <paragraph num="(a)"> <text>“Health care provider” means a person who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program.</text> </paragraph> <paragraph num="(b)"> <text>“Health care provider” includes a facility where health care is provided to patients or recipients, including:</text> <paragraph num="(i)"> <text>A facility, as defined in Health-General Article, §10-101(e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>An outpatient clinic;</text> </paragraph> <paragraph num="(v)"> <text>A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>An ambulatory surgical facility, as defined in Health-General Article, §19-3B-01, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(vii)"> <text>A nursing home, as defined in Health-General Article, §19-1401, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For purposes of this chapter, “health care provider” does not include a health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Implementation period” means the first 120 days after the effective date of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Incentive of equivalent value” means:</text> <paragraph num="(a)"> <text>Specific services;</text> </paragraph> <paragraph num="(b)"> <text>A gain-sharing arrangement;</text> </paragraph> <paragraph num="(c)"> <text>Rewards for quality and efficiency;</text> </paragraph> <paragraph num="(d)"> <text>In-kind payment; or</text> </paragraph> <paragraph num="(e)"> <text>Other items or services that can be assigned a specific monetary value.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Meaningful use” means the criteria and requirements established by the Centers for Medicare and Medicaid Services as detailed under 42 CFR 142, 143, 422, et al. (2010) and subsequent regulations.</text> </paragraph> <paragraph num="(10)"> <text>“Medicare and Medicaid EHR Incentive Programs” means the programs described at 42 CFR 412, 413, 422, and 495 (2010) and 42 CFR 412, 413, and 495 (2012), adopted by the Centers for Medicare and Medicaid Services (CMS) to implement provisions of the American Recovery and Reinvestment Act of 2009, the Medicare EHR Incentive Program as administered by CMS, and the Medicaid EHR Incentive Program as administered by Medicaid.</text> </paragraph> <paragraph num="(11)"> <text>“MHCC” or “Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(12)"> <text>“NCQA” means the National Committee for Quality Assurance, a health care quality accreditation, certification, and recognition body.</text> </paragraph> <paragraph num="(13)"> <text>“NPI” or “national provider identifier” means the unique individual identification number issued by the National Provider System to a health care provider typically used in administrative and financial transactions.</text> </paragraph> <paragraph num="(14)"> <text>Payor.</text> <paragraph num="(a)"> <text>“Payor” means a State-regulated carrier that issues or delivers health benefit plans in the State and includes:</text> <paragraph num="(i)"> <text>Aetna, Inc;</text> </paragraph> <paragraph num="(ii)"> <text>CareFirst BlueCross BlueShield;</text> </paragraph> <paragraph num="(iii)"> <text>CIGNA HealthCare Mid-Atlantic;</text> </paragraph> <paragraph num="(iv)"> <text>Coventry Health Care;</text> </paragraph> <paragraph num="(v)"> <text>Kaiser Permanente; and</text> </paragraph> <paragraph num="(vi)"> <text>United Healthcare, Mid-Atlantic Region.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Payor” does not include a managed care organization as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Practice panel” means:</text> <paragraph num="(a)"> <text>The patients who are Maryland residents and enrolled in a fully insured health benefit plan assigned by a payor to a provider within a primary care practice at the time the primary care practice requests an EHR incentive payment; or</text> </paragraph> <paragraph num="(b)"> <text>When a payor does not assign patients enrolled in a fully insured health benefit plan to a provider within a primary care practice, the patients who are Maryland residents and enrolled with that payor in a fully insured health benefit plan who have been treated by the primary care practice within the 24 months preceding a primary care practice’s request for an EHR adoption incentive payment.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Primary care practice” means a medical practice located in the State that is composed of:</text> <paragraph num="(a)"> <text>One or more physicians who provide health care in family practice, general practice, geriatric medicine, internal medicine, pediatric medicine, or gynecologic practice and that uses one of the following CMS specialty codes in claims submissions:</text> <paragraph num="(i)"> <text>Family practice (08);</text> </paragraph> <paragraph num="(ii)"> <text>General practice (01);</text> </paragraph> <paragraph num="(iii)"> <text>Geriatric medicine (38);</text> </paragraph> <paragraph num="(iv)"> <text>Internal medicine (11);</text> </paragraph> <paragraph num="(v)"> <text>Pediatric medicine (37); or</text> </paragraph> <paragraph num="(vi)"> <text>Obstetrics & Gynecology (16); or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>One or more nurse practitioners who provide health care in family practice, general practice, geriatric medicine, internal medicine, pediatric medicine, or gynecologic practice and that uses CMS taxonomy code in claims submissions:</text> <paragraph num="(i)"> <text>Adult Health (363LA2100X);</text> </paragraph> <paragraph num="(ii)"> <text>Family (363LF0000X);</text> </paragraph> <paragraph num="(iii)"> <text>Gerontology (363LG0600X );</text> </paragraph> <paragraph num="(iv)"> <text>Obstetrics & Gynecology (363LX0001X);</text> </paragraph> <paragraph num="(v)"> <text>Pediatric (363LP0200X );</text> </paragraph> <paragraph num="(vi)"> <text>Primary Care (363LP2300X); or</text> </paragraph> <paragraph num="(vii)"> <text>Women’s Health (363LW0102X).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“State” means the State of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Third-party administrator” means a person that is registered as an administrator under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Description."> <paragraph num="A."> <text>An EHR adoption incentive shall be available to a primary care practice that meets the requirements set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A payor may exclude from a primary care practice’s EHR adoption incentive calculation the payor’s patient members who were previously included in another primary care practice’s EHR adoption incentive calculation.</text> </paragraph> <paragraph num="C."> <text>A payor may, upon notification to a primary care practice:</text> <paragraph num="(1)"> <text>Request additional information from a primary care practice to validate the primary care practice’s EHR adoption incentive request; and</text> </paragraph> <paragraph num="(2)"> <text>Reduce a remaining EHR adoption incentive to a primary care practice if the payor determines that a duplicate payment or an overpayment has been made under this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The MHCC may conduct audits to determine compliance with this chapter as follows:</text> <paragraph num="(1)"> <text>A payor shall cooperate with the MHCC’s audit process and file information required by the MHCC in a timely manner;</text> </paragraph> <paragraph num="(2)"> <text>A primary care practice shall cooperate with the MHCC’s audit process and report requested information in a timely manner; and</text> </paragraph> <paragraph num="(3)"> <text>If an audit reveals noncompliance with this chapter, the MHCC may require corrective action.</text> </paragraph> </paragraph> <paragraph num="E."> <text>This chapter shall also apply to an entity that self-insures its health benefit plans, if federal law is amended to allow state regulation of such EHR payments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Participation Requirements."> <paragraph num="A."> <text>To be eligible for an EHR adoption incentive under this chapter, a primary care practice shall:</text> <paragraph num="(1)"> <text>Adopt a certified EHR;</text> </paragraph> <paragraph num="(2)"> <text>Complete and submit an EHR adoption incentive request to each appropriate payor from which the practice desires an incentive award; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate that the primary care practice has either:</text> <paragraph num="(a)"> <text>Attested to the current meaningful use requirements under the Medicare or Medicaid EHR Incentive Program; or</text> </paragraph> <paragraph num="(b)"> <text>Participates in any MHCC approved patient-centered medical home program and has achieved NCQA level two recognition.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An EHR adoption incentive request shall include the following:</text> <paragraph num="(1)"> <text>Practice specific information:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Address;</text> </paragraph> <paragraph num="(c)"> <text>Specialty;</text> </paragraph> <paragraph num="(d)"> <text>Organizational national provider identifier number; and</text> </paragraph> <paragraph num="(e)"> <text>Tax identification number;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The individual NPIs of each provider within the primary care practice;</text> </paragraph> <paragraph num="(3)"> <text>The estimated total number of patients on the practice panel, if available;</text> </paragraph> <paragraph num="(4)"> <text>The name and version of the certified EHR system implemented by the primary care practice;</text> </paragraph> <paragraph num="(5)"> <text>Documentation that the primary care practice meets the criteria for the EHR adoption incentive including:</text> <paragraph num="(a)"> <text>A copy of the confirmation received from CMS or Medicaid of acceptance of attestation to meaningful use by at least one physician or nurse practitioner within the practice; or</text> </paragraph> <paragraph num="(b)"> <text>A copy of the NCQA level two recognition letter; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An attestation signed by an authorized member of the primary care practice that:</text> <paragraph num="(a)"> <text>The information contained in the request is accurate;</text> </paragraph> <paragraph num="(b)"> <text>If the practice is led by a physician, all the physicians within the primary care practice are using the certified EHR system; and</text> </paragraph> <paragraph num="(c)"> <text>If the practice is led by a nurse practitioner, all the nurse practitioners within the primary care practice are using the certified EHR system</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A payor shall issue an EHR adoption incentive request acknowledgement letter as soon as is reasonably possible and no later than 45 days after receipt of an EHR adoption incentive request.</text> </paragraph> <paragraph num="D."> <text>The meaningful use attestation of a physician or nurse practitioner may only be included in a single EHR adoption incentive request to a payor.</text> </paragraph> <paragraph num="E."> <text>A payor may request additional information as necessary to determine the validity of an EHR adoption incentive request.</text> </paragraph> <paragraph num="F."> <text>A payor shall process and pay in full the adoption incentive within 75 days of receiving a complete EHR adoption incentive request.</text> </paragraph> <paragraph num="G."> <text>A payor shall provide each primary care practice requesting an EHR adoption incentive with a written notification regarding:</text> <paragraph num="(1)"> <text>The amount of the EHR adoption incentive awarded to the primary care practice;</text> </paragraph> <paragraph num="(2)"> <text>The method of distribution of the EHR adoption incentive; and</text> </paragraph> <paragraph num="(3)"> <text>The time period over which the incentive will be distributed.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A primary care practice that provided an attestation to meaningful use must give written notice within 90 days to each payor that awarded an EHR adoption incentive to the practice under the following circumstances in the event that the CMS, Medicaid, or its designated entity:</text> <paragraph num="(1)"> <text>Conducted a prepayment or post-payment audit of compliance with the participation requirements of the Medicare or Medicaid EHR Incentive Program regarding the physician or nurse practitioner identified by the primary care practice as part of its EHR adoption incentive request; and</text> </paragraph> <paragraph num="(2)"> <text>Determined that the physician or nurse practitioner had not met the requirements under the Medicare or Medicaid EHR Incentive Program.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Payors may request reimbursement of the incentive payments made under this chapter to the primary care practice in the event of notice provided by the primary care practice under §H of this regulation.</text> </paragraph> <paragraph num="J."> <text>Nothing in this chapter shall require a group model health maintenance organization to provide an incentive to a health care provider who is employed by a multispecialty group of physicians or nurse practitioners under contract with the group model health maintenance organization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Incentive Payment Calculation by Payor."> <paragraph num="A."> <text>An EHR adoption incentive is calculated at $25 per member, up to a maximum of $15,000, and limited to the payor’s patient members on the practice panel.</text> </paragraph> <paragraph num="B."> <text>Upon request by a primary care practice, a payor shall provide the practice, in a timely manner, with an accounting of its EHR adoption incentive including the names of each patient included in the EHR adoption incentive calculation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reporting."> <paragraph num="A."> <text>A payor shall submit:</text> <paragraph num="(1)"> <text>An annual report to the MHCC for calendar years 2011 — 2018 no later than 90 days after the end of each calendar year; and</text> </paragraph> <paragraph num="(2)"> <text>At the request of the MHCC, a payor shall submit an interim report within 30 days of the Commission’s request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The annual and interim reports shall include:</text> <paragraph num="(1)"> <text>The number of EHR adoption incentive requests received by the payor for the requested calendar year or time period;</text> </paragraph> <paragraph num="(2)"> <text>The number of EHR adoption incentive payment requests processed by the payor for the requested calendar year or time period;</text> </paragraph> <paragraph num="(3)"> <text>The total value of incentives distributed for the calendar year or time period; and</text> </paragraph> <paragraph num="(4)"> <text>Other information available to the payor and requested by the MHCC to determine the effectiveness of EHR adoption incentives programs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A payor shall submit a final report to the MHCC no later than May 31, 2017, that includes all information required in an annual report under this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Incentive Program Transition."> <paragraph num="A."> <text>A payor has until the end of the implementation period to implement this chapter’s requirements.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §E of this regulation, a primary care practice that received an incentive under earlier incentive program requirements is not eligible to receive an incentive under the requirements of this replacement chapter.</text> </paragraph> <paragraph num="C."> <text>A primary care practice may be eligible to receive an incentive provided under the requirements of an earlier EHR adoption incentive regulation if the practice, under an earlier EHR adoption incentive regulation:</text> <paragraph num="(1)"> <text>Did not receive an incentive payment; and</text> </paragraph> <paragraph num="(2)"> <text>Prior to the effective date of this chapter:</text> <paragraph num="(a)"> <text>Submitted an incentive application and payment request; or</text> </paragraph> <paragraph num="(b)"> <text>Submitted an incentive application but not an incentive payment request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A primary care practice in §C(1) and (2)(b) of this regulation shall have 60 days after the effective date of this replacement chapter to submit a payment request to the payor for a base and additional incentive, as provided in earlier regulations.</text> </paragraph> <paragraph num="E."> <text>Within 90 days after the effective date of this replacement chapter, a primary care practice that received an additional incentive that was less than or equal to the base incentive under earlier incentive program requirements may request that the payor award the difference between the previously received incentive payment and the incentive payment calculated under this replacement chapter based on the practice’s eligible patient enrollment with the payor at the time of the original payment.</text> </paragraph> <paragraph num="F."> <text>A payor shall process a payment request within 75 days of receiving a complete EHR incentive request from a primary care practice submitted under §§C — E of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-103(c)(2)(i) and (ii), 19-109(a)(1), and 19-143(d)(1), (2), (3), and (4) and(i), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 16, 2011 (38:10 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07 repealed and new Regulations .01 — .07 adopted effective June 9, 2014 (41:11 Md. R. 605)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective November 24, 2016 (43:23 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective November 24, 2016 (43:23 Md. R. 1279)</annotation> </annotations> </chapter> <chapter num="17" heading="Benchmarks for Preauthorization of Health Care Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to a payor that:</text> <paragraph num="(1)"> <text>Requires preauthorization for health care services; and</text> </paragraph> <paragraph num="(2)"> <text>Is required to report to the Maryland Health Care Commission on its attainment and plans for attainment of certain preauthorization benchmarks.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter does not apply to a pharmacy benefits manager that only provides services for:</text> <paragraph num="(1)"> <text>Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland..</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(2)"> <text>“Executive Director” means the Executive Director of the Commission or the Executive Director’s designee.</text> </paragraph> <paragraph num="(3)"> <text>“Health Care Service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Payor” means one of the following State-regulated entities that require preauthorization for a health care service:</text> <paragraph num="(a)"> <text>An insurer or nonprofit health service plan that provides hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State;</text> </paragraph> <paragraph num="(b)"> <text>A health maintenance organization that provides hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; or</text> </paragraph> <paragraph num="(c)"> <text>A pharmacy benefits manager that is registered with the Maryland Insurance Commissioner, except for a pharmacy benefits manager that only provides services for:</text> <paragraph num="(i)"> <text>Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Preauthorization” means the process of obtaining approval from a payor by meeting certain criteria before a certain health care service can be rendered by the health care provider.</text> </paragraph> <paragraph num="(6)"> <text>“Prescriber” means a health care practitioner who has the required license and, if necessary, scope of practice or delegation agreement that permits the health care practitioner to prescribe drugs to treat medical conditions or diseases.</text> </paragraph> <paragraph num="(7)"> <text>Step therapy or fail-first protocol" is a protocol established by an insurer, a nonprofit health service plan, a health maintenance organization, or a pharmacy benefits manager that requires a certain prescription drug or sequence of prescription drugs to be used by an insured individual or an enrollee before another specific prescription drug ordered by a prescriber is covered.</text> </paragraph> <paragraph num="(8)"> <text>“Supporting medical information” means:</text> <paragraph num="(a)"> <text>A paid claim from a payor that requires a step therapy or fail-first protocol for an insured or an enrollee;</text> </paragraph> <paragraph num="(b)"> <text>A pharmacy record that documents that a prescription has been filled and delivered to an insured or enrollee, or to a representative of an insured or enrollee; or</text> </paragraph> <paragraph num="(c)"> <text>Other information mutually agreed to that constitutes sufficient supporting medical information by an insured's or enrollee’s prescriber and a payor that requires a step therapy or fail-first protocol.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Benchmarks."> <paragraph num="A."> <text>Each payor shall establish and maintain online access for a provider to the following:</text> <paragraph num="(1)"> <text>A list of each health care service that requires preauthorization by the payor; and</text> </paragraph> <paragraph num="(2)"> <text>Key criteria used by the payor for making a determination on a preauthorization request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each payor shall establish and maintain an online process for:</text> <paragraph num="(1)"> <text>Accepting electronically a preauthorization request from a provider; and</text> </paragraph> <paragraph num="(2)"> <text>Assigning to a preauthorization request a unique electronic identification number that a provider may use to track the request during the preauthorization process, whether the request is tracked electronically, through a call center, or by fax.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each payor shall establish and maintain an online preauthorization system that meets the requirements of Health-General Article, §19-108.2(e), Annotated Code of Maryland, to:</text> <paragraph num="(1)"> <text>Approve in real time, electronic preauthorization requests for pharmaceutical services:</text> <paragraph num="(a)"> <text>For which no additional information is needed by the payor to process the preauthorization request; and</text> </paragraph> <paragraph num="(b)"> <text>That meet the payor’s criteria for approval;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Render a determination within 1 business day after receiving all pertinent information on requests not approved in real time, electronic preauthorization requests for pharmaceutical services that:</text> <paragraph num="(a)"> <text>Are not urgent; and</text> </paragraph> <paragraph num="(b)"> <text>Do not meet the standards for real-time approval under §C(1) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Render a determination within 2 business days after receiving all pertinent information, electronic preauthorization requests for health care services, except pharmaceutical services, that are not urgent.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Each payor that requires a step therapy or fail-first protocol shall:</text> <paragraph num="(1)"> <text>Establish and maintain an online process to allow a prescriber to override the step therapy or fail-first protocol if:</text> <paragraph num="(a)"> <text>The step therapy drug has not been approved by the United States Food and Drug Administration for the medical condition being treated; or</text> </paragraph> <paragraph num="(b)"> <text>A prescriber provides supporting medical information to the payor that a prescription drug covered by the payor:</text> <paragraph num="(i)"> <text>Was ordered by the prescriber for the insured or enrollee within the past 180 days; and</text> </paragraph> <paragraph num="(ii)"> <text>Based on the professional judgment of the prescriber, was effective in treating the insured's or enrollee's disease or medical condition;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide notice to prescribers regarding the availability of its online process; and</text> </paragraph> <paragraph num="(3)"> <text>Provide information to insureds or enrollees on the availability of the step therapy or fail-first protocol within its network.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall meet each benchmark within this chapter within 3 months of the payor's offering of services or benefits within the State and shall thereafter maintain the processes or actions required by each benchmark.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reporting."> <paragraph num="A."> <text>A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall report to the Commission in a form and manner specified by the Commission on its attainment of each benchmark in Regulation .03 of this chapter within 3 months of the payor’s offering of services or benefits within the State.</text> </paragraph> <paragraph num="B."> <text>If requested by the Commission, a payor shall demonstrate continued compliance with the benchmarks in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A payor that has been granted a waiver under Regulation .05 of this chapter shall notify the Executive Director if it can no longer demonstrate the extenuating circumstances for which the waiver was granted within 30 days after a payor can no longer demonstrate extenuating circumstances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Waiver from Benchmark Requirement."> <paragraph num="A."> <text>A payor may request that the Commission issue or renew a waiver from the requirement to meet a benchmark in Regulation .03 of this chapter by the demonstration of the following extenuating circumstances:</text> <paragraph num="(1)"> <text>For an insurer or nonprofit health service plan, a premium volume that is less than $1,000,000 annually in the State;</text> </paragraph> <paragraph num="(2)"> <text>For a group model health maintenance organization, as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, preauthorizations of health care services requested by providers not employed by the group model health maintenance organization; or</text> </paragraph> <paragraph num="(3)"> <text>Other circumstances determined by the Executive Director to be extenuating.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Submission of Request for Waiver or Renewal of Waiver.</text> <paragraph num="(1)"> <text>A request for a waiver or renewal of waiver shall be in writing and shall include:</text> <paragraph num="(a)"> <text>An identification of each preauthorization benchmark for which a waiver is requested; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed explanation of the extenuating circumstances necessitating the waiver.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A request for a waiver shall be filed with the Commission in accordance with the following:</text> <paragraph num="(a)"> <text>For renewal of a waiver, no later than 30 days prior to its expiration; or</text> </paragraph> <paragraph num="(b)"> <text>For a payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, within 3 months after the date the payor is authorized to provide benefits or services within the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Issuance of Waiver.</text> <paragraph num="(1)"> <text>The Executive Director may issue a waiver from a preauthorization benchmark to a payor that demonstrates extenuating circumstances within this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director will review and provide a decision to approve or deny all waiver requests within a reasonable time frame.</text> </paragraph> <paragraph num="(3)"> <text>A waiver or renewal of a waiver shall be valid for 2 years, unless withdrawn by the Executive Director.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Withdrawal of Waiver.</text> <paragraph num="(1)"> <text>The Executive Director may withdraw a waiver or renewal of a waiver if the Executive Director determines that the payor can no longer demonstrate extenuating circumstances.</text> </paragraph> <paragraph num="(2)"> <text>If the Executive Director withdraws a waiver or renewal of waiver, the Executive Director shall notify the payor, setting forth in writing the reasons for withdrawal.</text> </paragraph> <paragraph num="(3)"> <text>After a waiver or a renewal of a waiver is withdrawn, a payor shall submit a plan to the Executive Director within 30 days that includes a timeline for attaining each benchmark in Regulation .03 of this chapter in a format approved by the Commission.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Review of Denial or Withdrawal of Waiver.</text> <paragraph num="(1)"> <text>If the Executive Director has denied or withdrawn a waiver, a payor may seek Commission review of the denial or withdrawal by filing a written request for review with the Commission within 20 days of receipt of the Executive Director’s notice of denial or withdrawal of a waiver, which shall:</text> <paragraph num="(a)"> <text>State with particularity the grounds and factual basis for a payor’s disagreement with the denial or withdrawal decision;</text> </paragraph> <paragraph num="(b)"> <text>Specify the remedy requested; and</text> </paragraph> <paragraph num="(c)"> <text>If desired, include a written request to orally address the Commission, which shall be scheduled if requested.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The full Commission may review the written request for review of a denial or withdrawal of a waiver directly or, at the discretion of the Chair of the Commission, appoint a Commissioner to review the request submitted under §E(1) of this regulation, who will make a recommendation to the full Commission.</text> </paragraph> <paragraph num="(3)"> <text>If a written request was submitted under §E(1)(c) of this regulation, a payor may orally address the Commission before a determination is made by the Commission as to whether or not to issue or withdraw a waiver.</text> </paragraph> <paragraph num="(4)"> <text>After reviewing and considering a payor’s written request for review of the denial or withdrawal decision and any oral argument, if applicable, the full Commission shall issue a written decision affirming, reversing, or modifying the decision reviewed.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A waiver or renewal of waiver from the requirements of this chapter may not be sold, assigned, leased, or transferred.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fines."> <text>A payor that does not meet the reporting requirements of this chapter may be assessed a fine in accordance with COMAR 10.25.12.01, et seq.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-101 and 19-108.2, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 18, 2013 (40:3 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110)</annotation> </annotations> </chapter> <chapter num="18" heading="Health Information Exchanges: Privacy and Security of Protected Health Information"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>This chapter addresses the privacy and security of protected health information maintained by a health information exchange, or obtained or released by any person through a health information exchange by adopting specific requirements:</text> <paragraph num="(1)"> <text>To assure the privacy and security of protected health information accessed, used, or disclosed through a health information exchange, including protections for the secondary use of protected health information obtained, accessed, or released through a health information exchange;</text> </paragraph> <paragraph num="(2)"> <text>To govern the access, use, maintenance, and disclosure of protected health information through or by a health information exchange;</text> </paragraph> <paragraph num="(3)"> <text>To improve access to clinical records by treating clinicians; and</text> </paragraph> <paragraph num="(4)"> <text>To promote uses of a State-designated HIE that will assist public health agencies in reaching public health goals.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter applies to:</text> <paragraph num="(1)"> <text>An HIE, as defined in Regulation .02B(38) of this chapter, including:</text> <paragraph num="(a)"> <text>An individual or entity that determines, controls, or has discretion to administer any requirement, policy, or agreement that allows, enables, or requires the use of any technology or services for access, exchange, or use of electronic protected health information:</text> <paragraph num="(i)"> <text>Among more than two unaffiliated individuals or entities that are enabled to exchange electronic protected health information with each other; and</text> </paragraph> <paragraph num="(ii)"> <text>That is for a treatment, payment, or health care operations purpose, as those terms are defined in 45 CFR §164.501, regardless of whether the individuals or entities are subject to the requirements of 45 CFR Parts 160 and 164; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A health information technology developer of certified health information technology as that term is defined in Regulation .02B(39) of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A person who accesses, uses, or discloses protected health information through an HIE;</text> </paragraph> <paragraph num="(3)"> <text>Electronic health information stored in, or maintained by, an HIE; and</text> </paragraph> <paragraph num="(4)"> <text>A dispenser authorized by law to dispense noncontrolled prescription drugs to a patient or the patient’s agent in the State.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>Protected health information exchanged, accessed, used, or disclosed:</text> <paragraph num="(a)"> <text>Between a hospital and a credentialed professional;</text> </paragraph> <paragraph num="(b)"> <text>Among credentialed professionals of a hospital’s medical staff;</text> </paragraph> <paragraph num="(c)"> <text>Between a hospital and its affiliated ancillary clinical service provider who is affiliated with the hospital and who, if required by HIPAA, has entered into a business associate agreement with the hospital;</text> </paragraph> <paragraph num="(d)"> <text>Among entities under common ownership as defined at Health-General Article, §4-301, Annotated Code of Maryland, for health care treatment, payment, or health care operations purposes, as those terms are defined in 45 CFR §164.501;</text> </paragraph> <paragraph num="(e)"> <text>By a carrier, as defined in Insurance Article, §15-301, Annotated Code of Maryland, exchanging information as required by 45 CFR §156.221; or</text> </paragraph> <paragraph num="(f)"> <text>Between a carrier and its business associate, as defined in 45 CFR §160.103, if the organizational and technical processes provided or governed by the business associate are transactions, as defined in 45 CFR §160.103; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The use, access, or disclosure of protected health information using point-to-point transmission unless an HIE is involved in the transmission of the data.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In the event that an HIE is unable to meet a requirement of this chapter independently, it may do so by the execution of a written agreement or by requesting an exemption in accordance with Regulation .09G or H of this chapter.</text> </paragraph> <paragraph num="E."> <text>The requirements in this chapter are in addition to those set forth below:</text> <paragraph num="(1)"> <text>The Health Insurance Portability and Accountability Act of 1996, and the pertinent regulations at 45 CFR Parts 160 and 164;</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Consumer Protection Act, Commercial Law Article, Title 13, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>The Maryland Personal Information Protection Act, Commercial Law Article, Title 14, Subtitle 35, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>The Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Health General Article, §4-307, Annotated Code of Maryland, Confidentiality of Mental Health Records;</text> </paragraph> <paragraph num="(6)"> <text>16 CFR Part 318, Health Breach Notification Rule, adopted by the Federal Trade Commission pursuant to the HITECH Act;</text> </paragraph> <paragraph num="(7)"> <text>42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records;</text> </paragraph> <paragraph num="(8)"> <text>Titles IV and XI of the 21st Century Cures Act and the pertinent regulations, 45 CFR Part 171, and as defined at Regulation .02B(78) of this chapter; and</text> </paragraph> <paragraph num="(9)"> <text>All other applicable State and federal laws and regulations governing the use, access, maintenance, and disclosure of health information.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Nothing in this chapter shall prohibit:</text> <paragraph num="(1)"> <text>The Maryland Department of Health, the Commission, or the Health Services Cost Review Commission from using electronic health information, subject to federal and State law, for health regulatory and public health functions;</text> </paragraph> <paragraph num="(2)"> <text>The sharing or disclosing of information that is required to be exchanged under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>The sharing or disclosing of information that is required to be exchanged under federal law, including for the purposes of payment, as defined in 45 CFR § 164.501.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adjudication of claims” means the activities necessary for the adjudication or subrogation of a health benefit claim that has been filed or may be filed by a patient, or with the authorization of a patient on the patient’s behalf, including:</text> <paragraph num="(a)"> <text>Determinations of eligibility or coverage, including coordination of benefits or the determination of cost-sharing amounts;</text> </paragraph> <paragraph num="(b)"> <text>Reasonable prospective, concurrent, or retrospective utilization review or predetermination of benefit coverage;</text> </paragraph> <paragraph num="(c)"> <text>Review, audit, and investigation of a specific claim for payment of benefits with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges;</text> </paragraph> <paragraph num="(d)"> <text>Billing, claims management, collection activities, obtaining payment under a contract for reinsurance, and related health care data processing; and</text> </paragraph> <paragraph num="(e)"> <text>Risk adjustments based on enrollee health status and demographic characteristics.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Ancillary clinical service provider” means a health care provider who has a direct contractual agreement with the hospital to provide therapeutic, diagnostic, or custodial ancillary services for the hospital as part of its affiliation. Ancillary services may include skilled nursing, home care, outpatient rehabilitation and therapy, transportation, ambulatory surgery, dialysis, laboratory, radiology, pharmacy, and chemotherapy.</text> </paragraph> <paragraph num="(3)"> <text>“Application Programming Interface” or “API” has the same meaning as ‘Certified API Technology’ as stated at 45 CFR § 170.404.</text> </paragraph> <paragraph num="(4)"> <text>“Appropriate notice to one or more health care consumers” means notice, related to a request for individually identifiable health information for secondary use, that meets the following requirements:</text> <paragraph num="(a)"> <text>The notice:</text> <paragraph num="(i)"> <text>Must include educational information pertaining to the requesting entity's secondary use of data obtained through an HIE, including why the entity is requesting the data and how it intends to use the data;</text> </paragraph> <paragraph num="(ii)"> <text>May describe an ongoing scenario such as care coordination or other ongoing care management activities against which subsequent data may be requested by the care management organization from the HIE; in such cases, the potential need for and nature of such requests shall be included in the description of the initial request to the external review board and shall be plainly documented in the notice to health care consumers;</text> </paragraph> <paragraph num="(iii)"> <text>Must include a clear and detailed description of the steps a health care consumer must take in order to grant authorization for the use of their information or to deny authorization;</text> </paragraph> <paragraph num="(iv)"> <text>Must provide clear, detailed notice that the health care consumer's failure to respond could result in their information being disclosed without their authorization, if an independent external review committee waives authorization; and</text> </paragraph> <paragraph num="(v)"> <text>Must have characteristics detailed in Regulation .03B(2)(b)—(g) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The care management organization, or its third party, has provided to each health care consumer whose identifiable information is being requested:</text> <paragraph num="(i)"> <text>Notice as described above, using varied methods, where possible, to reach the health care consumer;</text> </paragraph> <paragraph num="(ii)"> <text>The opportunity to submit authorization or denial of authorization through various methods such as email, online, mail, and phone; and</text> </paragraph> <paragraph num="(iii)"> <text>At least 30 calendar days from the time of the first notice to respond to the notice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Authentication” means the process of establishing confidence in user identities electronically presented to an information system.</text> </paragraph> <paragraph num="(6)"> <text>“Authorization” has the meaning provided in 45 CFR §164.508.</text> </paragraph> <paragraph num="(7)"> <text>“Authorized purpose” means the specific reason consistent with this chapter and State and federal law for which an authorized user may use, access, or disclose protected health information through or from an HIE. The authorized purpose may include daily operations and maintenance of the HIE for:</text> <paragraph num="(a)"> <text>The staff of the HIE who has signed a confidentiality and nondisclosure agreement; and</text> </paragraph> <paragraph num="(b)"> <text>The staff of the HIE's contractor if the contractor:</text> <paragraph num="(i)"> <text>Has entered into a business associate agreement with the HIE; and</text> </paragraph> <paragraph num="(ii)"> <text>Has contractually agreed to limit access to the HIE only to its employees, agents, and independent contractors with a need-to-know; and who are under a confidentiality restriction, which may include a binding work force policy and procedure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Authorized user” means an individual identified by a participating organization or a health information exchange, including a health care consumer, who may use, access, or disclose protected health information through or from a health information exchange for a specific authorized purpose and whose HIE access is not currently suspended or terminated under Regulation .05, .07, or .09 of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Breach” has the meaning provided in 45 CFR §164.402.</text> </paragraph> <paragraph num="(10)"> <text>“Business associate” has the meaning provided in 45 CFR §160.103.</text> </paragraph> <paragraph num="(11)"> <text>“Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> <paragraph num="(12)"> <text>“Care management organization”, in the context of secondary use, means any entity that:</text> <paragraph num="(a)"> <text>Has a financial or specific care-related responsibilities for individuals with whom they may not have a treatment, payment, or health care operations relationship under 45 CFR §164.501(1); and</text> </paragraph> <paragraph num="(b)"> <text>Has the legal or regulatory authority to exercise the responsibilities stated in §B(12)(a) of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>Is operating in accordance with Maryland's All-Payer Model or successor agreement between the Centers for Medicare and Medicaid Services and the State of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>Does not include a third-party entity engaged by a participating organization to provide care management services on behalf of such participating organization for a primary use.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(14)"> <text>“Consent management application” means a software tool or platform designed to request, receive, store, and manage a person in interest’s consent preferences regarding the sharing of the patient’s electronic health information through an HIE.</text> </paragraph> <paragraph num="(15)"> <text>“Control” means providing a method by which the health care consumer can electronically provide instructions to an HIE regarding the disclosure of the patient's information being made available through the HIE, which may include specifying:</text> <paragraph num="(a)"> <text>The individuals and organizations to whom the HIE may disclose the patient's health information;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances (e.g., all, emergency only, inpatient, etc.) under which the patient's health information may be disclosed through the HIE; and</text> </paragraph> <paragraph num="(c)"> <text>What type of health information may be disclosed, such as prescription history, laboratory reports, hospital encounters, and to whom.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Core elements of the Master Patient Index (MPI)” are the minimum elements that are required for an HIE to identify a particular patient across separate clinical, financial, and administrative systems, as needed for exchanging health information electronically.</text> </paragraph> <paragraph num="(17)"> <text>“Core HIE education content” means the educational information developed and approved by the Maryland Health Care Commission, after consultation with interested parties, and includes a general overview of:</text> <paragraph num="(a)"> <text>The fundamentals of health information technology, including electronic health records and the exchange of electronic health information;</text> </paragraph> <paragraph num="(b)"> <text>Health information privacy and security laws; and</text> </paragraph> <paragraph num="(c)"> <text>The benefits and risks to patients of exchanging health information through an HIE as compared to opting-out and exchanging health information through a paper-based system.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Covered entity"” has the meaning provided in 45 CFR §160.103.</text> </paragraph> <paragraph num="(19)"> <text>“Credentialed professional” means an individual who has been credentialed by a hospital to provide clinical services to patients of the hospital. Credentialing includes the formal evaluation and verification of an individual's necessary qualifications, education, training, and professional license if applicable, through the collection, verification, and evaluation of data relevant to the individual's professional performance.</text> </paragraph> <paragraph num="(20)"> <text>“Data use agreement” means an agreement that:</text> <paragraph num="(a)"> <text>Is entered into by an HIE and an entity receiving data for secondary data use purposes, regardless of whether or not the entity is a covered entity as defined by HIPAA; and</text> </paragraph> <paragraph num="(b)"> <text>Requires:</text> <paragraph num="(i)"> <text>The receiving entity to accept and comply with the requirements in this chapter and, to the extent the receiving entity meets the definition of a business associate under HIPAA, current State and federal laws pertaining to business associates and business associate agreements;</text> </paragraph> <paragraph num="(ii)"> <text>Both parties to access, transmit, and protect the PHI in accordance with current legal requirements and industry standards and practices;</text> </paragraph> <paragraph num="(iii)"> <text>The receiving entity to destroy the PHI, including back-up and archived copies of the PHI, in accordance with industry standards and practices, when the purposes for which it has been requested are completed, unless retention of the PHI is otherwise required by law; and</text> </paragraph> <paragraph num="(iv)"> <text>The receiving entity not to reuse or disclose the PHI to any person or organization, except as required or permitted by law; or if disclosed to a third party, which will act on behalf of the receiving entity, the third party and the receiving entity enter a contractual agreement that requires the third party to be bound by the provisions of the data use agreement that applies to the receiving entity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“De-identified data” means health information that neither identifies nor provides a reasonable basis to identify an individual and that meets the standards and specifications provided in 45 CFR §164.514(a)—(b).</text> </paragraph> <paragraph num="(22)"> <text>“Disclose” or “disclosure” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of health information, including an acknowledgment that a health record on a particular patient or recipient exists, outside the entity holding the information.</text> </paragraph> <paragraph num="(23)"> <text>“Dispense” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland, but does not include giving a patient prescription drug samples in accordance with Health Occupations Article, §12-102(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>Dispenser.</text> <paragraph num="(a)"> <text>“Dispenser” means a person authorized by law to dispense a noncontrolled prescription drug to a patient or a patient’s agent in the State, including a nonresident pharmacy so authorized.</text> </paragraph> <paragraph num="(b)"> <text>“Dispenser” does not include:</text> <paragraph num="(i)"> <text>A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;</text> </paragraph> <paragraph num="(ii)"> <text>An opioid treatment services program, as defined by COMAR 10.47.07.02;</text> </paragraph> <paragraph num="(iii)"> <text>A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; or</text> </paragraph> <paragraph num="(v)"> <text>A pharmacy issued a waiver by the Department under COMAR 10.47.07.03G from reporting dispensing to hospice patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Download” means providing a method by which the health care consumer can obtain an electronic copy of the patient's information that:</text> <paragraph num="(a)"> <text>Is in a readily available industry standard format; and</text> </paragraph> <paragraph num="(b)"> <text>Allows the health care consumer to save, maintain, use, or transmit the patient's information.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Electronic health care transactions” means transactions, as defined by 45 CFR § 160.103, that meet the specifications of 45 CFR § 162.920.</text> </paragraph> <paragraph num="(27)"> <text>“Electronic health information” means health information that is in an electronic form.</text> </paragraph> <paragraph num="(28)"> <text>“Electronic health record” or “EHR” means an electronic record of health-related information on an individual that includes patient demographic and clinical health information that may be used for clinical diagnosis, treatment, improvement of health care quality, and patient care.</text> </paragraph> <paragraph num="(29)"> <text>“Electronic health record system” means technology that electronically captures, manages, and organizes health records and may have the capacity to:</text> <paragraph num="(a)"> <text>Provide clinical decision support;</text> </paragraph> <paragraph num="(b)"> <text>Support physician order entry;</text> </paragraph> <paragraph num="(c)"> <text>Capture and query information relevant to health care quality; and</text> </paragraph> <paragraph num="(d)"> <text>Exchange electronic health information with and integrate the information from other sources.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Emergency” has the meaning provided in Health-General Article, §4-301(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“External and independent review committee” means a group of individuals that:</text> <paragraph num="(a)"> <text>Is responsible for reviewing and making a determination regarding a request for a waiver of authorization related to population health management; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be minimally composed of:</text> <paragraph num="(i)"> <text>At least three health care consumer members, three health care provider members, one member representing the scientific community, one member with privacy and legal expertise, and one member with HIE expertise;</text> </paragraph> <paragraph num="(ii)"> <text>Members who have appropriate professional competencies necessary to review the request; and</text> </paragraph> <paragraph num="(iii)"> <text>More than half of the members are not affiliated with or related to any person affiliated with the requesting entity and are free from any conflicts of interest with the requesting entity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Federalwide assurance” or “FWA” means an agreement between an entity and the United States Department of Health and Human Services under which the entity agrees to comply with:</text> <paragraph num="(a)"> <text>Federal regulations concerning research involving human subjects;</text> </paragraph> <paragraph num="(b)"> <text>Department of Health and Human Services regulations found at 45 CFR Part 46;</text> </paragraph> <paragraph num="(c)"> <text>A statement of principles governing the entity in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the entity; and</text> </paragraph> <paragraph num="(d)"> <text>Other requirements of the agreement.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Granular patient consent” means expressed preferences made by a health care consumer regarding the disclosure, access, and use of the patient's protected health information according to the type of information, type of provider, purpose, or circumstance communicated by the health care consumer to the HIE through reasonable means specified by the HIE, which shall include paper and electronic means.</text> </paragraph> <paragraph num="(34)"> <text>“Health care” has the meaning provided in Health-General Article, §4-301(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(35)"> <text>“Health care consumer” or “consumer” means a recipient, a patient, or a person in interest, as defined in this regulation.</text> </paragraph> <paragraph num="(36)"> <text>“Health care provider” has the meaning provided in Health-General Article, §4-301(h), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(37)"> <text>“Health Data Utility” means an HIE that operates for the following purposes:</text> <paragraph num="(a)"> <text>The collection, aggregation, and analysis of clinical information, public health data, and electronic administrative health care transactions;</text> </paragraph> <paragraph num="(b)"> <text>The communication of data between public health officials and health care providers to advance disease control and health equity; and</text> </paragraph> <paragraph num="(c)"> <text>The enhancement and acceleration of interoperability of health information.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Health information” means any information, whether oral or recorded in any form or medium, including electronic health information, that:</text> <paragraph num="(a)"> <text>Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and</text> </paragraph> <paragraph num="(b)"> <text>Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Health information exchange” or “HIE” has the meaning provided in Health-General Article §4-301(i), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(40)"> <text>“Health information technology developer of certified health information technology” or “developer” means an entity that develops, sells, licenses, provides, or offers health information technology, as defined in 42 U.S.C. 300jj(5), to persons in the State and has one or more health information technology modules certified under a program that is kept or recognized by the National Coordinator in accordance with 42 U.S.C. 300jj-11(c)(5).</text> </paragraph> <paragraph num="(41)"> <text>Health Record.</text> <paragraph num="(a)"> <text>“Health record” means any health information, in any form or medium, created or transmitted by a participating organization or health care consumer that:</text> <paragraph num="(i)"> <text>Is entered in the record of a patient or recipient; and</text> </paragraph> <paragraph num="(ii)"> <text>Identifies or can readily be associated with the identity of a patient or a recipient.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health record” includes a medical record as defined in Health-General §4-301(k), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(42)"> <text>“HIE access matrix” means a document that is used by a participating organization to assign access to each authorized user and describes the type of protected health information (including, but not limited to, lab reports, prescription drug information, prior admissions to hospitals), that each authorized user is allowed to retrieve from an HIE. An HIE access matrix may specify a use case (including but not limited to electronic eligibility, clinical lab ordering/results delivery, electronic prescribing, medication history, clinical summary exchange, and other items) and corresponding associated data, including identified sensitive health information.</text> </paragraph> <paragraph num="(43)"> <text>“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, P.L.104191, as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended, and including as amended by the HITECH Act.</text> </paragraph> <paragraph num="(44)"> <text>“HITECH Act” mean the Health Information Technology for Economic and Clinical Health Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), as amended.</text> </paragraph> <paragraph num="(45)"> <text>“Hospital” has the meaning provided in Health-General Article, §19-301(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(46)"> <text>“Improvement of patient safety” means actions, strategies, or protocols to prevent health care errors, enhance the quality of care, and ensure a safe health care environment.</text> </paragraph> <paragraph num="(47)"> <text>“Individually identifiable health information” has the meaning provided in 45 CFR §160.103 and includes any health information that contains personal identifiers, as detailed in 45 CFR §164.514(b).</text> </paragraph> <paragraph num="(48)"> <text>“Institutional Review Board” or “IRB” means a committee or other group designated by an institution or affiliated with a State agency that performs a review of proposed research that has:</text> <paragraph num="(a)"> <text>Registered with the Office of Human Research Protections Electronic Submission System; and</text> </paragraph> <paragraph num="(b)"> <text>Obtained FWA approval from the Office of Human Research Protections.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“Interoperability” has the meaning provided in 45 CFR §170.102.</text> </paragraph> <paragraph num="(50)"> <text>“Legally protected health information” means the health information with a date of service after May 31, 2022, that is subject to restrictions under Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08, including:</text> <paragraph num="(a)"> <text>Mifepristone data, as defined by the Secretary; and</text> </paragraph> <paragraph num="(b)"> <text>As specified by the Secretary, the diagnosis, procedure, medication, and other codes related to:</text> <paragraph num="(i)"> <text>Abortion care; and</text> </paragraph> <paragraph num="(ii)"> <text>Sensitive health services, as defined by Health-General, §4-301, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(51)"> <text>“Master patient index” or “MPI” means a database that maintains a unique index identifier for each patient whose protected health information may be accessible through an HIE and is used to cross reference patient identifiers across multiple participating organizations to allow for patient search, patient matching, and consolidation of duplicate records.</text> </paragraph> <paragraph num="(52)"> <text>“MHCC” or the “Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(53)"> <text>“Nationally recognized standards” means technical standards for the exchange, integration, sharing, or retrieval of electronic health information considered reliable by the health IT industry nationally.</text> </paragraph> <paragraph num="(54)"> <text>“Noncontrolled Prescription Drugs” means a prescription drug, as defined in the Health Occupations Article § 21 201, that is not a controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(55)"> <text>“Non-HIPAA violation” means an inappropriate use, access, maintenance, or disclosure of health information that is not a HIPAA violation, but is inconsistent with State or federal law or this chapter, including a violation of 42 CFR Part 2.</text> </paragraph> <paragraph num="(56)"> <text>“Notice” (or “notify” or “notification”) means an action that is required to be taken in writing or by written request under this chapter by a person, including an HIE, a health care consumer, a participating organization, or the Commission, in order to provide information to another that:</text> <paragraph num="(a)"> <text>Is sent by letter delivered to the person's address of record;</text> </paragraph> <paragraph num="(b)"> <text>Uses one of the following electronic or digital mechanisms where the delivery is acknowledged or confirmed:</text> <paragraph num="(i)"> <text>An email, when the receiving person has provided an email address;</text> </paragraph> <paragraph num="(ii)"> <text>By a health care consumer using the receiver's website; or</text> </paragraph> <paragraph num="(iii)"> <text>By a health care consumer using a patient portal;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>By a health care consumer using telephonic or similar method, provided that a written confirmation of the conversation is provided to the health care consumer by the person receiving the notification or request by the following means:</text> <paragraph num="(i)"> <text>An email, when the health care consumer has provided an email address and delivery is acknowledged or confirmed; or</text> </paragraph> <paragraph num="(ii)"> <text>A letter delivered to the health care consumer's address of record; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Complies with HIPAA and all other applicable federal and State laws and regulations.</text> </paragraph> </paragraph> <paragraph num="(57)"> <text>“Opt out” means the explicit written notice by a health care consumer to an HIE or through the consent management application that the patient has elected not to participate in the HIE, so that the HIE shall not disclose such patient's protected health information, or data derived from such patient's health information, except as consistent with this chapter.</text> </paragraph> <paragraph num="(58)"> <text>“Part 2” means the federal Confidentiality of Substance Use Disorder Patient Records regulations found in 42 CFR Part 2 and supplemented by the final rule 82 FR 6052.</text> </paragraph> <paragraph num="(59)"> <text>“Part 2 information” means any information subject to the regulations under 42 CFR Part 2.</text> </paragraph> <paragraph num="(60)"> <text>“Participating organization” means a covered entity that enters into an agreement with an HIE that governs the terms and conditions under which its authorized users may use, access, or disclose protected health information through the HIE.</text> </paragraph> <paragraph num="(61)"> <text>“Patient” means an individual who receives health care and on whom a medical record is maintained.</text> </paragraph> <paragraph num="(62)"> <text>“Payor” means:</text> <paragraph num="(a)"> <text>An insurer that holds a certificate of authority in the State and provides health benefit plans in the State;</text> </paragraph> <paragraph num="(b)"> <text>A health maintenance organization that holds a certificate of authority in the State;</text> </paragraph> <paragraph num="(c)"> <text>A managed care organization authorized to receive Medicaid prepaid capitation payments under Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>A nonprofit health service plan that holds a certificate of authority in the State.</text> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Person” means an individual, trust or estate, general or limited partnership, joint stock company, unincorporated association or society, municipal or other corporation, incorporated association, limited liability partnership, limited liability company, the State, an agency or political subdivision of the State, a court, and any other governmental entity.</text> </paragraph> <paragraph num="(64)"> <text>“Person in interest” means any of the following, but does not include a participating organization:</text> <paragraph num="(a)"> <text>An adult on whom a health care provider maintains a medical record;</text> </paragraph> <paragraph num="(b)"> <text>A person authorized to consent to health care for an adult consistent with the authority granted, including without limitation, a guardian, surrogate, or person with a medical power of attorney;</text> </paragraph> <paragraph num="(c)"> <text>A duly appointed personal representative of a deceased person;</text> </paragraph> <paragraph num="(d)"> <text>Either:</text> <paragraph num="(i)"> <text>A minor, if the medical record concerns treatment to which the minor has the right to consent and has consented under Title 20, Subtitle 1 of the Health-General Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>A parent, guardian, custodian, or a representative of the minor designated by a court, in the discretion of the attending physician who provided the treatment to the minor, as provided in Health-General Article, §§20 -102 and 20-104, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If §B(55)(d) of this regulation does not apply to a minor:</text> <paragraph num="(i)"> <text>A parent of the minor, except if the parent's authority to consent to health care for the minor has been specifically limited by a court order or a valid separation agreement entered into by the parents of the minor; or</text> </paragraph> <paragraph num="(ii)"> <text>A person authorized to consent to health care for the minor consistent with the authority granted; or</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>An attorney appointed in writing by a person listed in this definition regarding matters subject to this chapter.</text> </paragraph> </paragraph> <paragraph num="(65)"> <text>“Point-to-point transmission” means a secure electronic transmission of PHI, including, but not limited to, records sent via facsimile or secure clinical messaging service, sent by a single entity that can be read only by the single receiving entity designated by the sender. A point-to-point transmission may be facilitated by an HIE and mirrors a paper-based exchange, such as a referral to a specialist, a discharge summary sent to where the patient is transferred, lab results sent to the practitioner who ordered them, or clinical information sent from a hospital to the patient's health plan for quality improvement or care management/coordination activities for such patient.</text> </paragraph> <paragraph num="(66)"> <text>“Population health management purpose” means the use of data, for secondary use, available from or through an HIE for population-based activities relating to the improvement of patient and population health or the reduction of health care costs, including but not limited to:</text> <paragraph num="(a)"> <text>Patient outreach activities that involve care management;</text> </paragraph> <paragraph num="(b)"> <text>Development or assessment of, quality indicators, patient patterns or outcomes, or support of quality reporting;</text> </paragraph> <paragraph num="(c)"> <text>Development and evaluation of innovative care delivery models and programs; and</text> </paragraph> <paragraph num="(d)"> <text>Risk assessment.</text> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Primary use of HIE data” or “primary use” means use and disclosure of data accessed, used, or disclosed through an HIE for purposes of:</text> <paragraph num="(a)"> <text>Treatment as defined by HIPAA;</text> </paragraph> <paragraph num="(b)"> <text>Payment as defined by HIPAA;</text> </paragraph> <paragraph num="(c)"> <text>Reporting to public health authorities in compliance with reporting required or permitted by law;</text> </paragraph> <paragraph num="(d)"> <text>Other uses or disclosures required or permitted by law and in accordance with this chapter, including those set forth in Health-General Article, §4-305(b), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(e)"> <text>Health care operations, as defined by HIPAA, for conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities.</text> </paragraph> </paragraph> <paragraph num="(68)"> <text>“Privacy board” means a group of individuals that:</text> <paragraph num="(a)"> <text>Is responsible for reviewing and making a determination on a request for secondary data for research purposes;</text> </paragraph> <paragraph num="(b)"> <text>Has the authority consistent with 45 CFR §164.512, including approval of a waiver or alteration of authorization requirement;</text> </paragraph> <paragraph num="(c)"> <text>Is designated or convened by the HIE, which may establish guidelines concerning a quorum;</text> </paragraph> <paragraph num="(d)"> <text>Shall meet the member composition requirements detailed in 45 CFR §164.512(i)(1)(i)(B)(1) and (3); and</text> </paragraph> <paragraph num="(e)"> <text>Shall assure that less than half of its members considering a request are affiliated with or related to any person affiliated with the requesting entity.</text> </paragraph> </paragraph> <paragraph num="(69)"> <text>“Protected health information” or “PHI” a subset of health information, means:</text> <paragraph num="(a)"> <text>Protected health information as defined in 45 CFR §160.103; or</text> </paragraph> <paragraph num="(b)"> <text>A medical record as defined in the Health-General Article, §4-301(i); and</text> </paragraph> <paragraph num="(c)"> <text>Includes sensitive health information.</text> </paragraph> </paragraph> <paragraph num="(70)"> <text>“Public health authority” has the meaning provided in 45 CFR §164.501.</text> </paragraph> <paragraph num="(71)"> <text>“Qualified research organization” means an entity that:</text> <paragraph num="(a)"> <text>Has entered into a data use agreement with the HIE from which data is being requested;</text> </paragraph> <paragraph num="(b)"> <text>Is determined, by an IRB or privacy board, to have expertise to carry out research specific to its request;</text> </paragraph> <paragraph num="(c)"> <text>Is determined, by an IRB or privacy board, to have a legitimate and credible reason or obligation to carry out research specific to its request; and</text> </paragraph> <paragraph num="(d)"> <text>Is a participating organization, public health authority, or is engaged in joint research with a participating organization or public health authority.</text> </paragraph> </paragraph> <paragraph num="(72)"> <text>“Query” means to electronically search for information available through an HIE using the services provided by the HIE.</text> </paragraph> <paragraph num="(73)"> <text>“Research” means the use of secondary data available from or through an HIE for the systematic investigation, including research development, testing, preparation, and evaluation, designed to develop or contribute to generalizable knowledge as defined in 45 CFR §164.501 and 45 CFR §46.102, including the use of de-identified data and limited data sets.</text> </paragraph> <paragraph num="(74)"> <text>“Secondary use of HIE data” or “secondary use” means any use or disclosure of data accessed, used or disclosed through an HIE that is not a primary use. Examples of secondary use include, but are not limited to, use of HIE data for conducting research, improving patient safety, marketing, or the sale of HIE data.</text> </paragraph> <paragraph num="(75)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(76)"> <text>“Sensitive health information” means a subset of PHI, which consists of:</text> <paragraph num="(a)"> <text>Part 2 information;</text> </paragraph> <paragraph num="(b)"> <text>Legally protected health information; or</text> </paragraph> <paragraph num="(c)"> <text>Any other information that has specific legal protections in addition to those required under HIPAA or the Maryland Confidentiality of Medical Records Act.</text> </paragraph> </paragraph> <paragraph num="(77)"> <text>“State-designated HIE” means an HIE designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(78)"> <text>“State health improvement program” means a State initiative designed to enhance public health through strategic planning, targeted interventions, and collaboration with stakeholders and the federal government, including State efforts in support of the Total Cost of Care model and successor models agreed to by the federal government and the State.</text> </paragraph> <paragraph num="(79)"> <text>“Submit”, when used in reference to consumer-submitted data, means providing a method by which the health care consumer can electronically upload information to the HIE to then be made available to authorized users of the HIE.</text> </paragraph> <paragraph num="(80)"> <text>“System administrator” means an individual employee within a participating organization (or an individual employed by a contractor to the participating organization) who is designated by the participating organization to manage the user accounts of specified individuals within the participating organization in coordination with an HIE.</text> </paragraph> <paragraph num="(81)"> <text>“Third party system” means hardware or software provided by an external entity to a participating organization, which interoperates with an HIE to allow an authorized user access to information through the HIE and may include an electronic health record system.</text> </paragraph> <paragraph num="(82)"> <text>“21st Century Cures Act” means the 21st Century Cures Act, P.L. 114-255, as amended, and the pertinent regulations at 45 CFR Parts 156, 170, and 171 and 42 CFR Parts 422, 431, 438, 457, 482, and 485.</text> </paragraph> <paragraph num="(83)"> <text>“Unusual finding” means an irregularity in the manner in which use, access, maintenance, disclosure, or modification of health information or sensitive health information transmitted to or through an HIE should occur that could give rise to a breach, a violation under this chapter or a violation of other applicable privacy or security laws.</text> </paragraph> <paragraph num="(84)"> <text>“Use” has the meaning provided in 45 CFR §160.103.</text> </paragraph> <paragraph num="(85)"> <text>“User accounts” mean the records associated with an authorized user's credentials and activities with an HIE or a third party system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Rights of a Health Care Consumer Concerning Information Accessed, Used, or Disclosed Through an HIE."> <paragraph num="A."> <text>A health care consumer has the following rights in accordance with the requirements specified in this section:</text> <paragraph num="(1)"> <text>The right to have information regarding the health care consumer's rights under these regulations readily available to assist the health care consumer in making an informed decision concerning:</text> <paragraph num="(a)"> <text>The accessibility of a patient's protected health information electronically through an HIE; and</text> </paragraph> <paragraph num="(b)"> <text>The risks and benefits of participating in the HIE.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The right to opt out of an HIE.</text> <paragraph num="(a)"> <text>A health care consumer has the right to opt out of an HIE at any time and refuse access to the patient's PHI through an HIE, except when a disclosure is limited to:</text> <paragraph num="(i)"> <text>Core elements of the MPI;</text> </paragraph> <paragraph num="(ii)"> <text>A disclosure that a person is required to make under federal or State law requirements;</text> </paragraph> <paragraph num="(iii)"> <text>Results of a diagnostic procedure sent to the health care provider who ordered the procedure or another provider as designated by the ordering provider as part of the care delivery of a patient;</text> </paragraph> <paragraph num="(iv)"> <text>Information regarding prescription medications dispensed or filled by a pharmacy, sent to the health care provider who ordered the prescriptions or another health care provider as designated by the ordering health care provider;</text> </paragraph> <paragraph num="(v)"> <text>Public health authorities for reporting purposes required, authorized, or otherwise compliant with applicable law; or</text> </paragraph> <paragraph num="(vi)"> <text>Communications permitted under HIPAA or State law without a health care consumer's consent or authorization when using point-to-point.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provided, however, that §A(2)(a)(iii), (iv), and (vi) of this regulation shall not apply to disclosures of sensitive health information, which receive additional protections consistent with Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(c)"> <text>A health care consumer shall be advised in writing by the HIE receiving the opt-out notice or request that opting out does not preclude any participating organization that has received or accessed PHI via the HIE prior to such opt-out, and incorporated such PHI into its records, from retaining such information in its records.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall make a good faith effort to facilitate a health care consumer's amendment of the patient's health information available through the HIE by informing the health care consumer how to seek amendment of the information.</text> <paragraph num="(a)"> <text>An HIE shall send information regarding the process for amending health information being made available through the HIE within 20 days of receiving notice from a health care consumer of a desire to amend the patient's health information available through the HIE and shall include the contact information of relevant participating organizations that provided the information; and</text> </paragraph> <paragraph num="(b)"> <text>This process shall be in accordance with the requirements specified in Health-General Article, §4-304(b), Annotated Code of Maryland and HIPAA, including 45 CFR §164.526.</text> </paragraph> <paragraph num="(c)"> <text>An HIE shall make a good faith effort to notify the participating organization of each authorized user who has accessed, used, or disclosed the health information that has subsequently been amended.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The right to resume participation in an HIE after previously opting out in accordance with these regulations. Any such resumption of participation shall be upon written notice or request by the health care consumer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An HIE shall provide needed information about the HIE to a health care consumer whose protected health information is maintained by a health information exchange, or may be accessed, used, or disclosed through the HIE.</text> <paragraph num="(1)"> <text>An HIE shall develop, adopt, implement, and keep current a health care consumer education plan that considers stakeholder input.</text> <paragraph num="(a)"> <text>The health care consumer education plan shall include the core HIE education content as defined in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>The health care consumer education plan shall outline how the HIE will make available the following information to health care consumers:</text> <paragraph num="(i)"> <text>A description of each type of patient health information that may be used, accessed or disclosed through the HIE;</text> </paragraph> <paragraph num="(ii)"> <text>The health information maintained by the HIE;</text> </paragraph> <paragraph num="(iii)"> <text>The specific details concerning who may access, use, or disclose a patient's health information and for what purpose;</text> </paragraph> <paragraph num="(iv)"> <text>The privacy and security measures that the HIE has implemented to protect health information, and a detailed explanation of what happens if there is a breach that results in unauthorized access to protected health information;</text> </paragraph> <paragraph num="(v)"> <text>A health care consumer's rights regarding the HIE and the control over, protection of, use of, and correction of each type of health information;</text> </paragraph> <paragraph num="(vi)"> <text>The process provided for a health care consumer to exercise the health care consumer's rights, including a detailed description of the steps a health care consumer needs to take in order to opt out from participation in the HIE;</text> </paragraph> <paragraph num="(vii)"> <text>The implications of a health care consumer's decision to opt out of participation in an HIE and not permit the disclosure of that consumer's PHI to authorized users, except as otherwise permitted under applicable law; and</text> </paragraph> <paragraph num="(viii)"> <text>The HIE's policies and procedures, including without limitation, policies and procedures consistent with these regulations regarding how the health care consumer may gain access to the patient's health information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE shall develop and implement health care consumer education materials as provided in §B(1) of this regulation. Such education materials shall have the following characteristics:</text> <paragraph num="(a)"> <text>Provide a balanced perspective, outlining the various points of view concerning each subject matter, including the risks and benefits associated with sharing protected health information electronically through the HIE;</text> </paragraph> <paragraph num="(b)"> <text>Are not inaccurate or misleading;</text> </paragraph> <paragraph num="(c)"> <text>Minimize the use of technical terms and, when such terms are necessary, clearly define the technical terms;</text> </paragraph> <paragraph num="(d)"> <text>Use plain language that is easily understandable to each health care consumer population served, taking into account the various levels of education, understanding, and interest across that population;</text> </paragraph> <paragraph num="(e)"> <text>Use text and illustrations that are culturally sensitive, language appropriate, and that recognize user diversity including ethnicity, age, race, and gender;</text> </paragraph> <paragraph num="(f)"> <text>Update material to include and incorporate new information; and</text> </paragraph> <paragraph num="(g)"> <text>Specify the time sensitivity of any material included.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall cooperate with applicable State agencies to educate health care consumers consistent with a statewide education plan approved by such applicable State agency.</text> </paragraph> <paragraph num="(4)"> <text>An HIE shall make health care consumer educational materials readily available, at no charge, to participating organizations and the participating organizations’ users through distribution channels such as websites, postal mail, email, secure third-party smart phone applications, and any other reasonable media or distribution channel commonly used and generally available to the HIE and health care consumer.</text> </paragraph> <paragraph num="(5)"> <text>In addition to the foregoing requirements, with regard to sensitive health information, the health care consumer educational content shall include:</text> <paragraph num="(a)"> <text>The scope of sensitive health information;</text> </paragraph> <paragraph num="(b)"> <text>The health care consumer’s right to control sensitive health information;</text> </paragraph> <paragraph num="(c)"> <text>The method by which to engage in the granular patient consent process;</text> </paragraph> <paragraph num="(d)"> <text>The method or methods by which the health care consumer can access the patient’s own sensitive health information;</text> </paragraph> <paragraph num="(e)"> <text>The circumstances under which an HIE must restrict or may disclose legally protected health information; and</text> </paragraph> <paragraph num="(f)"> <text>The method by which a health care consumer can request that a patient’s legally protected health information be disclosed to a specific health care provider.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>When an HIE updates its health care consumer educational content, the HIE shall timely make the updated materials available to health care consumers.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An HIE shall comply with the following requirements to allow a health care consumer to obtain information concerning a patient's PHI that may be available through the HIE.</text> <paragraph num="(1)"> <text>An HIE shall provide the following information to the health care consumer, upon written notice or request by the health care consumer, describing what PHI is available through the HIE concerning the specified patient:</text> <paragraph num="(a)"> <text>The participating organization that disclosed the PHI to the HIE;</text> </paragraph> <paragraph num="(b)"> <text>The date the PHI was disclosed to the HIE; and</text> </paragraph> <paragraph num="(c)"> <text>The type of PHI disclosed to the HIE, if known by the HIE.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE shall provide written information, in accordance with this Regulation, to health care consumers concerning the methods available to such health care consumers to access a patient's PHI that is available through the HIE.</text> <paragraph num="(a)"> <text>If the patient's PHI is directly available electronically to the health care consumer through the HIE, the HIE shall advise the health care consumer how to obtain the PHI electronically.</text> </paragraph> <paragraph num="(b)"> <text>If the patient's PHI is not directly available electronically to the health care consumer through the HIE, the HIE shall, within 7 days from receipt of such health care consumer's written notice or request, provide the health care consumer with the contact information for each participating organization that has disclosed information to the HIE and received information from the HIE concerning the patient, so that the health care consumer may gain access to the patient's health information directly from each participating organization.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall make a good faith effort to facilitate a health care consumer's amendment of the patient's health information available through the HIE by informing the health care consumer how to seek amendment of the information.</text> <paragraph num="(a)"> <text>An HIE shall send information regarding the process for amending health information being made available through the HIE within 20 days of receiving notice from a health care consumer of a desire to amend the patient's health information available through the HIE and shall include the contact information of relevant participating organizations that provided the information; and</text> </paragraph> <paragraph num="(b)"> <text>This process shall be in accordance with the requirements specified in Health-General Article, §4-304(b), Annotated Code of Maryland and HIPAA, including 45 CFR §164.526.</text> </paragraph> <paragraph num="(c)"> <text>An HIE shall make a good faith effort to notify the participating organization of each authorized user who has accessed, used, or disclosed the health information that has subsequently been amended.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon receipt of written notice or request, an HIE shall provide each health care consumer with a report detailing any disclosure through the HIE for a time period specified by the health care consumer, of the patient's PHI. In the case of recurring disclosures to the same entity for the same purpose, a summary report may be provided by the HIE. However, if the health care consumer requests the details of the summary report, the HIE shall promptly provide them.</text> <paragraph num="(a)"> <text>The time period specified by the health care consumer shall not exceed the data retention period as specified in the HIPAA Privacy Rule, 45 CFR §164.528.</text> </paragraph> <paragraph num="(b)"> <text>The report shall specify the following for each instance that the patient's PHI was disclosed during the time frame reflected in the report:</text> <paragraph num="(i)"> <text>The name of each authorized user;</text> </paragraph> <paragraph num="(ii)"> <text>The name of the participating organization to which the authorized user is affiliated, if such information is kept by the HIE in the ordinary course of business;</text> </paragraph> <paragraph num="(iii)"> <text>The date and time of the disclosure;</text> </paragraph> <paragraph num="(iv)"> <text>The type of PHI disclosed, if known by the HIE; and</text> </paragraph> <paragraph num="(v)"> <text>The name of the participating organization that made the protected health information available to the HIE.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An HIE shall acknowledge a health care consumer's written notice or request for the report within 10 business days of receipt of the request.</text> </paragraph> <paragraph num="(d)"> <text>An HIE shall respond to a health care consumer's written notice or request with either the requested report or with a written explanation why such report is unavailable, when it will be available, or where the health care consumer may obtain the requested information, in accordance with 45 CFR §164.528(a)(2)(D)(3). The HIE shall respond within a reasonable time frame, but not later than 30 days of the initial written notice or request by the health care consumer.</text> <paragraph num="(i)"> <text>An HIE shall provide up to two copies annually of the report at no cost to the health care consumer, upon written notice or request by the consumer. If the report is available in an electronic format, it shall be provided to the consumer in a generally available electronic format such as PDF, if so requested, at no additional charge.</text> </paragraph> <paragraph num="(ii)"> <text>For any additional report, the HIE may charge a reasonable fee not to exceed the cost to provide the additional report, but no more than the allowable amount in accordance with Health-General Article, §4-304, Annotated Code of Maryland, and 45 CFR §164.524(c)(4).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Consent Management Application.</text> <paragraph num="(1)"> <text>The State-designated HIE shall implement a consent management application that:</text> <paragraph num="(a)"> <text>Allows a person in interest to opt out of or opt in to having a patient’s electronic health information shared or disclosed by an HIE;</text> </paragraph> <paragraph num="(b)"> <text>Allows a person in interest to view the interested patient’s opt-out status.</text> </paragraph> <paragraph num="(c)"> <text>Informs the person in interest of the types of electronic health information that may be shared or disclosed by the State-designated HIE in accordance with §A(2)(a) of this regulation notwithstanding the choice to opt out;;</text> </paragraph> <paragraph num="(d)"> <text>Enables HIEs to readily identify information as to whether a person in interest has opted out of sharing the patient’s electronic health information; and</text> </paragraph> <paragraph num="(e)"> <text>At least includes:</text> <paragraph num="(i)"> <text>Personal identifiers consisting of the full name, date of birth, mailing address, telephone number, medical record number, and other unique identifiers of the patient and person in interest, if not the patient;</text> </paragraph> <paragraph num="(ii)"> <text>The person in interest’s communication contact preferences;</text> </paragraph> <paragraph num="(iii)"> <text>The relationship of the person in interest to the patient; and</text> </paragraph> <paragraph num="(iv)"> <text>The date the patient’s consent preferences were last updated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 12 months of the effective date of this regulation, the State-designated HIE shall make the consent management application it develops available to registered HIEs.</text> </paragraph> <paragraph num="(3)"> <text>The State-designated HIE shall implement the consent management application with a secure electronic interface that supports standardized interoperability between various recipient HIE systems.</text> </paragraph> <paragraph num="(4)"> <text>HIE Connection to the Consent Management Application.</text> <paragraph num="(a)"> <text>Exception. Section D(4)(b) of this regulation does not apply to an HIE that solely exchanges electronic health information with other HIEs and does not have any health care providers as a participating organization.</text> </paragraph> <paragraph num="(b)"> <text>An HIE shall:</text> <paragraph num="(i)"> <text>Establish bi-directional connectivity with the consent management application within 12 months of receiving notification from the State-designated HIE that the application is operational;</text> </paragraph> <paragraph num="(ii)"> <text>Update the HIE's system with the most recent version of the consent management application data at least every 5 business days;</text> </paragraph> <paragraph num="(iii)"> <text>Update the consent management application with any opt-out or opt-in requests it has received from an HIE or directly from a person in interest within 5 business days;</text> </paragraph> <paragraph num="(iv)"> <text>Withhold sharing or disclosure of the electronic health information of a patient to the extent the consent management application indicates that the patient has opted out of having electronic health information shared or disclosed by an HIE, except to the extent permitted by §A(2) of this regulation; and</text> </paragraph> <paragraph num="(v)"> <text>Electronically notify authorized users when a patient has restricted data sharing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>An HIE shall implement the consent management application in a manner that is consistent with this chapter, its existing policies and procedures regarding use and disclosure of PHI and other personal identifiable information, and its technological capabilities.</text> </paragraph> <paragraph num="(6)"> <text>An HIE shall place a link on its website directing a person in interest to the State-designated HIE’s website to globally opt out or opt in to having a patient’s electronic health information shared or disclosed by an HIE.</text> </paragraph> <paragraph num="(7)"> <text>An HIE shall continue to accept opt-out and opt-in requests from health care consumers directly.</text> </paragraph> <paragraph num="(8)"> <text>The State-designated HIE shall promptly notify the Commission and all HIEs any time the consumer management application is not operational and when services are resumed.</text> </paragraph> <paragraph num="(9)"> <text>An HIE is not required to comply with §D(4)(b) of this regulation when:</text> <paragraph num="(a)"> <text>An emergency exists and all requirements under Regulation .11 of this chapter have been met; or</text> </paragraph> <paragraph num="(b)"> <text>The consent management application is not operational.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Section D of this regulation shall be in addition to any restrictions on the disclosure of sensitive health information, consistent with Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An HIE shall:</text> <paragraph num="(1)"> <text>Establish and maintain an online process that allows health care consumers to obtain an electronic report detailing any disclosures of their information through the HIE in accordance with §C(4)(b) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Implement and maintain compliance with the provisions detailed in Regulation .12A(1)(7), B(1)(2), and C(4)(b)(d) of this chapter in implementing §E(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An HIE shall take affirmative steps to protect a patient's protected health information, including sensitive health information, that is accessible to or through the HIE from a breach or a non-HIPAA violation.</text> <paragraph num="(1)"> <text>An HIE shall have an easily accessible and convenient method by which a person may notify the HIE concerning a potential or an actual breach or a non-HIPAA violation.</text> </paragraph> <paragraph num="(2)"> <text>When an HIE is notified in writing of a potential or an actual breach or a non-HIPAA violation, the HIE shall:</text> <paragraph num="(a)"> <text>Acknowledge receipt of the notification within 1 business day;</text> </paragraph> <paragraph num="(b)"> <text>Begin an investigation concerning the matter upon receipt of the notification in compliance with Regulation .07 of this chapter and;</text> </paragraph> <paragraph num="(c)"> <text>In accordance with Regulation .08 of this chapter, provide the person filing the notification and each health care consumer whose protected health information was breached with information concerning the determination and resolution of the matter by the HIE.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall implement robust technical measures consistent with generally accepted industry best practices to assure valid patient identification and minimize patient record mismatches.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An HIE shall implement a process to allow a health care consumer to make an educated decision regarding the patient's participation in an HIE, opting out from such participation, or opting to resume participation in the HIE system, in accordance with this regulation.</text> <paragraph num="(1)"> <text>An HIE shall maintain a log that records each patient's participation status over time; and</text> <paragraph num="(a)"> <text>The HIE shall retain the log for the duration required by State or federal law, whichever requires a longer retention; and</text> </paragraph> <paragraph num="(b)"> <text>The HIE shall keep the log in a retrievable storage medium.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE may not disclose a patient's PHI if the health care consumer has submitted a written notice or request to opt out of the HIE in accordance with §(A)(2) of this regulation except as otherwise permitted under applicable law and in accordance with this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An HIE may not disclose information derived from a patient's PHI, including for secondary use, if the health care consumer has submitted a written notice or request to opt-out of the HIE, except as otherwise permitted under applicable law.</text> </paragraph> <paragraph num="(4)"> <text>An HIE may not unreasonably deny a health care consumer’s expressed preferences.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The following requirements shall apply to all communications between an HIE and a health care consumer:</text> <paragraph num="(1)"> <text>An HIE shall implement a process to allow a health care consumer to communicate with the HIE about the patient's participation status through an appropriate medium of the health care consumer's choice, including the following:</text> <paragraph num="(a)"> <text>By telephone, via a toll-free number;</text> </paragraph> <paragraph num="(b)"> <text>By mail, via a standardized form;</text> </paragraph> <paragraph num="(c)"> <text>By fax, via a standardized form;</text> </paragraph> <paragraph num="(d)"> <text>Online, via a secure website; and</text> </paragraph> <paragraph num="(e)"> <text>In person at the HIE's offices during business hours.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A health care consumer’s communication opting out or opting in to an HIE shall be made:</text> <paragraph num="(a)"> <text>In writing;</text> </paragraph> <paragraph num="(b)"> <text>Online; or</text> </paragraph> <paragraph num="(c)"> <text>By telephone, if the HIE confirms the action with a written communication to the health care consumer in accordance with §H(5)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall take appropriate measures to assure that a health care consumer who communicates with the HIE is authorized to act on behalf of the patient.</text> </paragraph> <paragraph num="(4)"> <text>An HIE shall implement the health care consumer's requested action within 5 business days of receipt of the health care consumer's written or online request concerning:</text> <paragraph num="(a)"> <text>Opting out of the HIE; and</text> </paragraph> <paragraph num="(b)"> <text>Resuming participation in the HIE after previously opting out.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An HIE shall provide to each health care consumer the option to receive confirmation of any change in the patient's participation status. If a health care consumer requests such confirmation in writing, the HIE shall:</text> <paragraph num="(a)"> <text>Send the confirmation of participation status change within 3 business days of the effective date of change of such patient's participation status; and</text> </paragraph> <paragraph num="(b)"> <text>If consistent with all applicable privacy and security law and regulations, including HIPAA and applicable State law and regulations, send the confirmation of status change through one of the following methods as specified by the health care consumer:</text> <paragraph num="(i)"> <text>An email sent to the email address specified by the health care consumer;</text> </paragraph> <paragraph num="(ii)"> <text>A letter to an address specified by the health care consumer;</text> </paragraph> <paragraph num="(iii)"> <text>A letter by fax to a fax number specified by the health care consumer;</text> </paragraph> <paragraph num="(iv)"> <text>A letter given to the health care consumer at the HIE during normal business hours; or</text> </paragraph> <paragraph num="(v)"> <text>A text message sent to the number specified by the health care consumer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>When a health care consumer changes the patient's participation status, the HIE shall provide the following to the health care consumer and, unless the patient is a minor or subject to a power of attorney or otherwise unable to handle his or her own affairs, to the patient:</text> <paragraph num="(a)"> <text>Information concerning when the status change will become effective; and</text> </paragraph> <paragraph num="(b)"> <text>Information concerning what information will be excluded from the HIE regarding a health care consumer who opts out.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A participating organization shall comply with the following requirements to assure patient and health care consumer rights.</text> <paragraph num="(1)"> <text>A participating organization shall inform each health care consumer no later than the first medical encounter following enrollment of the organization in an HIE, by written and oral notice, of:</text> <paragraph num="(a)"> <text>Such organization's participation in an HIE, including in such organization's Notice of Privacy Practices under HIPAA; and</text> </paragraph> <paragraph num="(b)"> <text>Information concerning the health care consumer's right to opt out from participation in the HIE and the process to opt out; and</text> </paragraph> <paragraph num="(c)"> <text>The types of information the participating organization will disclose to the HIE and for what purposes information accessed through the HIE may be used for treatment, payment, health care operations, and secondary use as described in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to applicable HIPAA notification requirements, a participating organization shall notify each health care consumer whose protected health information, including sensitive health information, is breached or is maintained, accessed, used, or disclosed in a manner that constitutes a non-HIPAA violation in accordance with Regulation .08 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Access, Use, or Disclosure of Sensitive Health Information."> <paragraph num="A."> <text>Consistency with Disclosure Requirements Under Federal and State Law.</text> <paragraph num="(1)"> <text>A person shall comply with all relevant State and federal laws, including 42 CFR Part 2, and Health-General Article, §4-302.5, Annotated Code of Maryland, concerning the access, use, or disclosure of sensitive health information through an HIE and maintenance of such information by an HIE.</text> </paragraph> <paragraph num="(2)"> <text>If federal or State law requires written consent or authorization for access, use, or disclosure of sensitive health information, a person shall obtain consent or authorization consistent with the applicable law prior to the access, use, or disclosure of sensitive health information to and through an HIE to an authorized recipient.</text> </paragraph> <paragraph num="(3)"> <text>If federal or State law does not require written consent or authorization for access, use, or disclosure of sensitive health information, a person may not require consent or authorization prior to the access, use, or disclosure of the sensitive health information through an HIE.</text> </paragraph> <paragraph num="(4)"> <text>An HIE shall use only point-to-point transmission to allow access, use, or disclosure of the sensitive health information through an HIE, unless the HIE implements:</text> <paragraph num="(a)"> <text>Nationally recognized standards that support control by the health care consumer over the electronic exchange of the patient's sensitive health information consistent with the privacy and consent directives made by the health care consumer;</text> </paragraph> <paragraph num="(b)"> <text>Electronic exchange controls and processes that:</text> <paragraph num="(i)"> <text>Support granular patient consent for the electronic transmission of sensitive health information consistent with applicable State and federal laws concerning the access, use, or disclosure of sensitive health information, including applicable standards and technical requirements in accordance with Part 2; and</text> </paragraph> <paragraph num="(ii)"> <text>Assure that the health care consumer's granular consent controls remain associated with the sensitive health information and are adhered to as the information is transmitted through, maintained, or disclosed by the HIE; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Health care consumer educational content:</text> <paragraph num="(i)"> <text>That is developed and established in coordination with the Commission and stakeholders;</text> </paragraph> <paragraph num="(ii)"> <text>That is kept current; and</text> </paragraph> <paragraph num="(iii)"> <text>The receipt of which shall be acknowledged by the health care consumer as part of the granular consent process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>In the case of the improper access, use, maintenance, or disclosure of sensitive health information, including an inadvertent release through an HIE, a participating organization shall take the following actions in addition to any other requirement imposed under federal or State law:</text> <paragraph num="(a)"> <text>Take all steps necessary to immediately stop any further improper access, use, disclosure, or release of the patient's sensitive health information through the HIE and the improper maintenance of such information by the HIE; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with Regulation .08 of this chapter, notify each health care consumer whose sensitive health information has been accessed, used, maintained, or disclosed in violation of applicable State or federal laws, including a non-HIPAA violation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Procedure for Disclosing or Re-disclosing of Part 2 Health Information.</text> <paragraph num="(1)"> <text>An HIE shall be in compliance with Part 2</text> </paragraph> <paragraph num="(2)"> <text>A participating organization that is a Part 2 program, as that term is defined by Part 2, shall identify itself as such and clearly indicate with all of its patient records any limits on use or disclosure required by Part 2.</text> </paragraph> <paragraph num="(3)"> <text>An HIE or participating organization that receives Part 2 information may not re-disclose such information without appropriate patient consent or authorization except as permitted by applicable federal and State laws and regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures for Disclosing or Re-Disclosing Legally Protected Health Information.</text> <paragraph num="(1)"> <text>An HIE shall be in compliance with Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08.</text> </paragraph> <paragraph num="(2)"> <text>By January 8, 2024, an HIE shall submit to the Commission:</text> <paragraph num="(a)"> <text>An affirmation that it:</text> <paragraph num="(i)"> <text>Possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law;</text> </paragraph> <paragraph num="(ii)"> <text>Is parsing restricted codes and conveying all other information in the health record that is not prohibited by law to exchange; and</text> </paragraph> <paragraph num="(iii)"> <text>Possesses the technological capacity to allow a consumer to request and consent to the exchange of legally protected health information to a specific treating provider; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An implementation plan that includes:</text> <paragraph num="(i)"> <text>An affirmation that, despite its best efforts, the HIE lacks the technological capability to fully comply with §C(1) of this regulation as of January 8, 2024, including a detailed explanation of the HIE’s limitations;</text> </paragraph> <paragraph num="(ii)"> <text>A detailed description of the steps the HIE is taking to ensure compliance with §C(1) of this regulation by June 1, 2024;</text> </paragraph> <paragraph num="(iii)"> <text>A timeline to implement the requirements of Health-General Article §4-302.5, Annotated Code of Maryland, by June 1, 2024; and</text> </paragraph> <paragraph num="(iv)"> <text>A description of the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an HIE submits an implementation plan in accordance with §C(2)(b) of this regulation, the HIE shall:</text> <paragraph num="(a)"> <text>Notify all participating organizations by January 8, 2024, that the HIE is unable to comply with §C(1) of this regulation with a written notice that describes the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan;</text> </paragraph> <paragraph num="(b)"> <text>Provide a status report to the Commission by April 1, 2024, detailing the progress the HIE has made under its implementation plan; and</text> </paragraph> <paragraph num="(c)"> <text>Submit validation to the Commission by June 1, 2024, that it possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Commission shall consider an HIE’s implementation plan and reported progress when assessing penalties for a violation of this section.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for Accessing, Using, or Disclosing Health Information Through an HIE."> <paragraph num="A."> <text>As a requirement of participation in an HIE, the HIE shall require each participating organization to enter into a binding participation agreement that:</text> <paragraph num="(1)"> <text>Requires the participating organization and each authorized user to comply with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Requires the participating organization and each authorized user to comply with all applicable federal and State privacy and security laws; and</text> </paragraph> <paragraph num="(3)"> <text>Includes a business associate agreement:</text> <paragraph num="(a)"> <text>In compliance with 45 CFR §164.504; and</text> </paragraph> <paragraph num="(b)"> <text>If the participating organization will maintain Part 2 information, the business associate agreement shall comply with the additional requirements that apply to a qualified service organization under 42 C.F.R. §2.11.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Permits PHI disclosed through the HIE to the authorized user of a participating organization to be incorporated into the patient’s medical record kept by such participating organization, and requires compliance with all applicable federal and State laws.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An HIE shall only disclose PHI through an HIE for a primary use consistent with the following:</text> <paragraph num="(1)"> <text>The disclosure shall be only to an authorized user for the specific purpose for which that authorized user is given access to the PHI; and</text> </paragraph> <paragraph num="(2)"> <text>All disclosures shall be in full compliance with these regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission may suspend the registration, in accordance with Regulation .09 of this chapter, of a registered HIE that inappropriately discloses to any person any PHI, or health information derived from PHI, that is available through the HIE’s infrastructure, except as consistent with or otherwise permitted by this chapter and applicable federal or State law.</text> </paragraph> <paragraph num="D."> <text>To assure that only an authorized user accesses, uses, or discloses PHI through or from an HIE, an HIE shall:</text> <paragraph num="(1)"> <text>Develop and maintain an HIE access matrix that includes the defined HIE access levels available to each authorized user.</text> <paragraph num="(a)"> <text>The HIE access matrix shall be used for the following purposes:</text> <paragraph num="(i)"> <text>To assign an HIE access level to each staff member of the HIE or its contractor that allows only the minimum necessary access to PHI to perform that staff member’s authorized purpose; and</text> </paragraph> <paragraph num="(ii)"> <text>To assist each participating organization and its system administrator in assigning the appropriate HIE access level to each authorized user of that participating organization.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The HIE shall review its HIE access matrix annually and revise it as necessary to reflect relevant changes in technology, standards, or law; and</text> </paragraph> <paragraph num="(c)"> <text>The HIE shall have the necessary technological capabilities in its core infrastructure to limit an authorized user’s access to the HIE according to the then currently assigned access level of its access matrix.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide technical assistance and guidance to the system administrator of each participating organization in assigning the appropriate HIE access level to each of its authorized users;</text> </paragraph> <paragraph num="(3)"> <text>Comply, at a minimum, with the most recent Level 2 requirements set by the National Institute of Standards and Technology (NIST), as set forth in April 2006 in Special Publication 800-63 (Version 1.0.2): Electronic Authentication Guideline for both Registrations and for Registration Record Retention; and</text> </paragraph> <paragraph num="(4)"> <text>Adopt and implement an authentication process that:</text> <paragraph num="(a)"> <text>Requires the authentication of an authorized user at each “log in” prior to allowing that individual access to the HIE;</text> </paragraph> <paragraph num="(b)"> <text>Requires a single factor authentication with two characteristics that include a user name and a password, along with an additional security precaution, which may include a security question or a device registration.</text> </paragraph> <paragraph num="(c)"> <text>Ensures that the data stored in the HIE that is used to authenticate an authorized user is encrypted to the level set by industry best practices; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Accept as valid a third party system’s authentication of an authorized user accessing the HIE through that third party system, as long as such access and third party system:</text> <paragraph num="(a)"> <text>Permits the HIE to audit and monitor the user’s HIE activities; and</text> </paragraph> <paragraph num="(b)"> <text>The HIE has received written assurances from the third party system that it is compliant with these regulations and all applicable federal and State privacy and security regulations.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If an HIE learns or has reason to believe that the third party system is not compliant, then it shall immediately cease acceptance of such third party system’s authentication of authorized users until the third party system demonstrates compliance to the reasonable satisfaction of the HIE.</text> </paragraph> </paragraph> <paragraph num="E."> <text>To assure that only an authorized user accesses, uses, or discloses PHI through or from an HIE, a participating organization shall comply with each of the following.</text> <paragraph num="(1)"> <text>A participating organization shall designate a system administrator who is capable of carrying out the requirements set forth in §F of this regulation on behalf of the participating organization prior to exchanging any PHI through the HIE.</text> </paragraph> <paragraph num="(2)"> <text>A participating organization shall promptly inform its system administrator of any circumstances that require any of the actions described under §F of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>A participating organization shall ensure that any third party system it uses appropriately authenticates an authorized user prior to allowing that individual access to the HIE through the third party system.</text> <paragraph num="(a)"> <text>The third party system shall authenticate an authorized user at each “log in.”</text> </paragraph> <paragraph num="(b)"> <text>The third party system shall ensure that the data stored in the system which is used to authenticate an authorized user is encrypted to the level set by industry best practices.</text> </paragraph> <paragraph num="(c)"> <text>A participating organization shall adopt and implement a protocol to be followed by a third party system that requires a user name, a password, and an additional security precaution which may include a security question or a device registration.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A participating organization shall inform the HIE concerning the following:</text> <paragraph num="(a)"> <text>The designation of the system administrator, or any change in such designation, within 5 business days of any such designation or change;</text> </paragraph> <paragraph num="(b)"> <text>A breach or non-HIPAA violation by a person who had or has access to the HIE through the participating organization; or</text> </paragraph> <paragraph num="(c)"> <text>An act or event that it has a reasonable basis to believe is or may be a significant violation of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The system administrator of a participating organization shall carry out each of the following measures on behalf of the participating organization.</text> <paragraph num="(1)"> <text>The system administrator shall identify each authorized user within the participating organization and shall note the individual’s assigned unique user name in accordance with the most recent applicable standards issued by NIST, or other comparable standards generally adopted by the health care and HIE industry.</text> </paragraph> <paragraph num="(2)"> <text>The system administrator and HIE shall coordinate with the Commission to determine a methodology for assigning each authorized user with a unique user name and password and to assure that all HIEs use a commonly accepted protocol to avoid the possibility of duplicate user names and passwords.</text> </paragraph> <paragraph num="(3)"> <text>The system administrator, in coordination with the HIE, shall assign to each authorized user an access level that appropriately corresponds to that individual’s role within the participating organization and the permitted access to PHI available through the HIE on behalf of the participating organization.</text> </paragraph> <paragraph num="(4)"> <text>The system administrator shall modify in a timely manner an authorized user’s access level as appropriate to reflect any change in that individual’s role within the participating organization; and</text> </paragraph> <paragraph num="(5)"> <text>The system administrator shall immediately terminate access through an HIE in accordance with Regulation .07 of this chapter for any authorized user:</text> <paragraph num="(a)"> <text>Who is suspended by the participating organization;</text> </paragraph> <paragraph num="(b)"> <text>Who is no longer associated with the participating organization; or</text> </paragraph> <paragraph num="(c)"> <text>Who no longer requires access to the HIE.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The system administrator shall attest to the HIE regarding the appropriateness of a staff member to be an authorized user and that the HIE access level assigned to that staff member corresponds to the authorized user’s role within the participating organization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Auditing Requirements."> <paragraph num="A."> <text>In order to ensure that only an authorized user who is appropriately authenticated is granted access to HIE information, an HIE shall:</text> <paragraph num="(1)"> <text>Develop and implement protocols, methodologies, and a monitoring approach designed to discover any unusual finding, which may be identified within an audit of the user access logs, including conducting ongoing electronic monitoring of user access logs and investigate any unusual findings in accordance with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Conduct each audit under this regulation in accordance with best practices using industry accepted standards and methodologies;</text> </paragraph> <paragraph num="(3)"> <text>Conduct random audits of the user access logs to identify any unusual finding; and, if the HIE has been notified about an unusual finding or has reason to believe that inappropriate access has occurred, conduct random audits at least every other week until the unusual finding or inappropriate access has been mitigated;</text> </paragraph> <paragraph num="(4)"> <text>At least quarterly, conduct random audits of security measures and any other forms of data security in place to determine if they are still sufficient and compliant with applicable standards;</text> </paragraph> <paragraph num="(5)"> <text>Investigate each unusual finding identified in the access log audit to determine if there has been a violation of Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Resolve an unusual finding by:</text> <paragraph num="(a)"> <text>Taking actions necessary to correct each identified technical control deficiency; or</text> </paragraph> <paragraph num="(b)"> <text>Taking remedial action under Regulation .07 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Report any unusual finding to each participating organization involved in the unusual finding, as follows:</text> <paragraph num="(a)"> <text>If the unusual finding involves fewer than 10 patients, within 5 business days after the unusual finding is discovered;</text> </paragraph> <paragraph num="(b)"> <text>If the unusual finding involves between 10 and 50 patients, within 2 business days after the unusual finding is discovered; and</text> </paragraph> <paragraph num="(c)"> <text>If the unusual finding involves more than 50 patients, within 1 business day after the unusual finding is discovered; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Maintain an audit trail of user access logs in a retrievable storage medium, as follows:</text> <paragraph num="(a)"> <text>The HIE shall perform periodic testing to ensure that the storage medium being used will allow the data to be recovered.</text> </paragraph> <paragraph num="(b)"> <text>The HIE shall perform periodic testing and implement upgrades and updates to ensure that the storage medium is secure and has not been improperly accessed.</text> </paragraph> <paragraph num="(c)"> <text>The data shall be kept for the longest duration of time identified in applicable State and federal requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When an HIE has identified a potential breach or non-HIPAA violation, the HIE shall conduct an unscheduled audit within 30 days that:</text> <paragraph num="(1)"> <text>Gathers relevant information to determine if there is a violation;</text> </paragraph> <paragraph num="(2)"> <text>Reflects the size and scope of the potential violation; and</text> </paragraph> <paragraph num="(3)"> <text>Complies with Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An HIE shall at least annually enlist a qualified independent auditing firm to audit its privacy, security, and legal compliance in accordance with the following provisions:</text> <paragraph num="(1)"> <text>The audit shall:</text> <paragraph num="(a)"> <text>Assess potential risks to protect the confidentiality, integrity, and security of PHI;</text> </paragraph> <paragraph num="(b)"> <text>Assess operational compliance with State and federal law, including the requirements of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Be designed to determine the adequacy of business and technology-related controls, policies, and procedures and other safeguards employed by third-party service organizations based on industry standards and best practices; and</text> </paragraph> <paragraph num="(d)"> <text>Include an assessment of cybersecurity posture and compliance with this chapter, applicable provisions in HIPAA and HITECH, and recognized security practices by way of accreditation or certification from a nationally recognized entity.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE shall develop auditing policies and procedures for the independent auditor to conduct such an audit, which shall include, at a minimum:</text> <paragraph num="(a)"> <text>The scope of the audit;</text> </paragraph> <paragraph num="(b)"> <text>A description of all third-party organizations and processes to review and assess related privacy and security controls and audit reports;</text> </paragraph> <paragraph num="(c)"> <text>Interviews with relevant staff, including those from third-party service organizations, as appropriate;</text> </paragraph> <paragraph num="(d)"> <text>Names and contact information of all persons responsible for reviewing and maintaining privacy and security to include the implementation of corrective actions to address apparent gaps; and</text> </paragraph> <paragraph num="(e)"> <text>Time frames for completing audits and related activities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An HIE shall provide the audit findings to the Commission in accordance with Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>If an audit detects unusual findings, an HIE shall investigate and resolve the matter in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon the request of the Commission and consistent with the specifications in such request, an HIE shall:</text> <paragraph num="(1)"> <text>Provide a summary of the results of any audit that is required by this chapter, and any corrective action plans identified by the audit, to the Commission; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct an additional unscheduled audit within 180 days of the request and provide the results of such an audit to the Commission within the time frame specified by the Commission.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If an HIE’s audit reveals information that demonstrates a pattern of inappropriate access, use, maintenance, or disclosure of information that constitutes a breach or non-HIPAA violation, or if the health information of more than ten patients was improperly used, accessed, maintained, or disclosed during the 12 months prior to the audit, then:</text> <paragraph num="(1)"> <text>The HIE shall use the findings from the audit to:</text> <paragraph num="(a)"> <text>Educate and train all impacted persons, which may include its workforce, participating organizations, and authorized users on proper access, use, and disclosure of information through or from the HIE; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate and implement new control measures, including policies, procedures, or technology, to ensure proper use and access of the HIE; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The HIE shall take the appropriate measures specified in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If an HIE’s audit reveals information that demonstrates a pattern of noncompliance with State and federal law, then:</text> <paragraph num="(1)"> <text>The HIE shall use the findings from the audit to:</text> <paragraph num="(a)"> <text>Educate and train all impacted persons, which may include its workforce, participating organizations, and authorized users on proper access, use, and disclosure of information through or from the HIE; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate and implement new control measures, including policies, procedures, or technology, to ensure compliance; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The HIE shall take the appropriate measures specified in the Regulation. 07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An HIE and its participating organizations shall adopt an access and auditing plan that requires the HIE and each participating organization, as applicable, to conduct a random audit of the HIE access logs on a monthly basis.</text> <paragraph num="(1)"> <text>The random audit included in the plan shall be assigned to the HIE or the participating organizations according to their respective system's technological capabilities.</text> </paragraph> <paragraph num="(2)"> <text>The access and auditing plan shall include:</text> <paragraph num="(a)"> <text>The manner used to identify a non-HIPAA violation of this chapter or a breach;</text> </paragraph> <paragraph num="(b)"> <text>The method to be used to report a non-HIPAA violation of this chapter or a breach;</text> </paragraph> <paragraph num="(c)"> <text>The reasonable steps that will be taken to promptly mitigate a non-HIPAA violation of this chapter or a breach; and</text> </paragraph> <paragraph num="(d)"> <text>A review of access logs to ensure that only an authorized user who is appropriately authenticated is granted access to HIE information through a participating organization's third party system.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a participating organization does not conduct its own audit, it shall review the HIE access logs relating to the participating organization within 10 days of receipt from the HIE. An HIE shall send HIE access logs to each participating organization no less than quarterly.</text> <paragraph num="(a)"> <text>The purpose of the review is to:</text> <paragraph num="(i)"> <text>Detect patterns of inappropriate access, use, maintenance, or disclosure; and</text> </paragraph> <paragraph num="(ii)"> <text>Compare the PHI accessed by the authorized user with the health care provided to assure that the authorized user's use of the HIE is appropriate.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In order to conduct the quarterly review, the HIE shall provide a participating organization with audit record information concerning the participating organization's authorized users access of the HIE that shall include:</text> <paragraph num="(i)"> <text>The name and access level of each user;</text> </paragraph> <paragraph num="(ii)"> <text>The name of the patient whose PHI was accessed;</text> </paragraph> <paragraph num="(iii)"> <text>The date and time of access; and</text> </paragraph> <paragraph num="(iv)"> <text>The type of PHI that was accessed.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Remedial Actions to Be Taken by an HIE."> <paragraph num="A."> <text>An HIE shall immediately suspend a person's access to the HIE when it is necessary to avoid serious harm to the privacy or security of health information accessed, used, or disclosed through or from the HIE.</text> <paragraph num="(1)"> <text>An HIE may, in its sole discretion, suspend a person's access to the HIE pursuant to this section before an investigation under Regulation .07B of this chapter is completed. In addition, if the HIE determines that serious harm to the privacy or security of health information or an ongoing risk of improper use, access, maintenance, or disclosure of PHI may occur prior to conclusion of an investigation, it shall suspend a person’s access to the HIE pursuant to this section before an investigation is complete.</text> </paragraph> <paragraph num="(2)"> <text>Such suspension shall continue until the underlying threat to the privacy or security of health information is contained.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An HIE shall conduct an investigation if there is reason to believe that a breach or non-HIPAA violation has occurred.</text> <paragraph num="(1)"> <text>The HIE shall begin the investigation upon learning of the allegations giving rise to a potential breach or violation.</text> </paragraph> <paragraph num="(2)"> <text>The HIE shall conduct the investigation in a thorough, timely, professional manner and take all necessary actions to gather information concerning the potential breach or violation that reflects the size and scope of such potential breach or violation.</text> </paragraph> <paragraph num="(3)"> <text>If appropriate, an investigation shall include an audit under Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Upon the completion of an investigation, which shall not exceed 14 business days, an HIE shall:</text> <paragraph num="(a)"> <text>Make a written finding describing the results of an investigation and provide a copy to the Commission; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain records of each investigation (audits, complaints, breaches, non-HIPAA violations) for at least 5 years from the date of completion of such investigation or 5 years from the date a minor patient becomes an adult, whichever is longer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If an HIE has a reasonable belief that a breach or non-HIPAA violation has occurred, either as a result of an investigation or otherwise, the HIE shall:</text> <paragraph num="(1)"> <text>For a breach, follow Regulation .08 of this chapter and federal breach notification requirements and timelines;</text> </paragraph> <paragraph num="(2)"> <text>For non-HIPAA violations, submit a corrective action plan to the Commission within 10 business days of conclusion of its investigation, which shall include:</text> <paragraph num="(a)"> <text>Any remedial action necessary to address the breach or violation as soon as practicable;</text> </paragraph> <paragraph num="(b)"> <text>Any steps necessary to correct the underlying problem, such as a change in processes or procedures, new technology, and training; and</text> </paragraph> <paragraph num="(c)"> <text>An appropriate and reasonable time frame for implementing the remedial action;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within a reasonable time frame, but in no event more than 10 business days following the investigation, provide the following to the Commission, and to the participating organizations:</text> <paragraph num="(a)"> <text>A copy of the findings of the investigation, excluding any PHI or sensitive health information;</text> </paragraph> <paragraph num="(b)"> <text>Each remedial action to be taken by each person and the associated time frame of the remedial action;</text> </paragraph> <paragraph num="(c)"> <text>Any action necessary to mitigate the harm that may be caused by the breach or the non-HIPAA violation;</text> </paragraph> <paragraph num="(d)"> <text>The identity of the person that is responsible for carrying out each action to mitigate harm; and</text> </paragraph> <paragraph num="(e)"> <text>Any future action that the HIE may take, including suspension of access or progressive discipline, if a person does not comply with the remedial action;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Immediately suspend access of a person when one of the following occurs:</text> <paragraph num="(a)"> <text>Available information demonstrates a significant breach by the person;</text> </paragraph> <paragraph num="(b)"> <text>Available information demonstrates a significant non-HIPAA violation by the person;</text> </paragraph> <paragraph num="(c)"> <text>Available information demonstrates a violation of State or federal law relevant to privacy or security by the person;</text> </paragraph> <paragraph num="(d)"> <text>The person has sold health information accessed through the HIE in violation of these regulations;</text> </paragraph> <paragraph num="(e)"> <text>The person has failed to carry out the remedial actions identified by the HIE; or</text> </paragraph> <paragraph num="(f)"> <text>The Commission issues a request for suspension of the person as provided in Regulation .09 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Notify the health care consumer pursuant to Regulation .08 of this chapter, if such notification is required under applicable law, including HIPAA, or if so directed by the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>After verifying that each remedial action is complete, an HIE may reinstate a person's authorization to access information through the HIE provided that:</text> <paragraph num="(1)"> <text>The Commission has not revoked the person's access to the HIE as provided in Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The HIE modifies the person's access as needed to ensure compliance with this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A person may file a written notice or request with the Commission that the Commission review an HIEs action under Regulation .07 of this chapter when the person has reason to believe that the HIE has acted inappropriately.</text> <paragraph num="(1)"> <text>A request for review shall be filed within 30 days after the person knew or had reason to know of the HIEs action in question;</text> </paragraph> <paragraph num="(2)"> <text>The request for review shall set forth each reason why the person believes that the HIE's action is inappropriate.</text> </paragraph> <paragraph num="(3)"> <text>The Commission may determine that no investigation is necessary or may take action under Regulation .09C.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An HIE shall provide notice of each suspension and each reinstatement of a person's authorization to access information through an HIE in the following manner:</text> <paragraph num="(1)"> <text>The HIE shall send an electronic notice to the person who is the subject of the action within 24 hours of the suspension or the reinstatement and to the Commission on a monthly basis.</text> </paragraph> <paragraph num="(2)"> <text>The notice shall include:</text> <paragraph num="(a)"> <text>The name of the person who is the subject of the action;</text> </paragraph> <paragraph num="(b)"> <text>The name of any affected participating organization;</text> </paragraph> <paragraph num="(c)"> <text>The basis for the suspension or reinstatement; and</text> </paragraph> <paragraph num="(d)"> <text>The effective date of the suspension or reinstatement.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The notice shall not include PHI.</text> </paragraph> <paragraph num="(4)"> <text>The notice shall not be considered confidential.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Notice of Breach and non-HIPAA Violation."> <paragraph num="A."> <text>Notification of a breach shall be required consistent with notification requirements of applicable federal and State laws, including HIPAA and the HITECH Act.</text> </paragraph> <paragraph num="B."> <text>When federal or State law does not require an HIE or other entity to provide notification to a participating organization or to an effected health care consumer, or when Part 2 does not mandate other notification requirements, the HIE shall provide notification of breach and, if applicable, non-HIPAA violations pursuant to this chapter.</text> <paragraph num="(1)"> <text>If the investigation under Regulation .07 of this chapter concluded that there was a breach or non-HIPAA violation, in addition to applicable HIPAA notification requirements, the HIE shall notify:</text> <paragraph num="(a)"> <text>The person who notified the HIE of the potential breach or non-HIPAA violation, if applicable, and to the extent permitted by HIPAA and other federal and State privacy laws;</text> </paragraph> <paragraph num="(b)"> <text>Any participating organization that has provided health information regarding the health care consumer involved; and</text> </paragraph> <paragraph num="(c)"> <text>Each patient or person in interest acting on behalf of each patient whose PHI or sensitive health information was inappropriately accessed or disclosed due to a breach or non-HIPAA violation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to other requirements specified in this section, the HIE shall include in its notification, the contact information for the HIE, including the address and toll-free telephone number where the health care consumer can learn more information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notification to a Health Care Consumer.</text> <paragraph num="(1)"> <text>If the entity providing the notification under this Regulation has knowledge that another person is acting as the health care consumer for the patient, the entity shall provide the notification to that person instead of the patient.</text> </paragraph> <paragraph num="(2)"> <text>A notification to the health care consumer required under this Regulation shall be:</text> <paragraph num="(a)"> <text>In writing by first-class mail to the health care consumer, at the last known address of the health care consumer, if no prior election as to notice has been made; or</text> </paragraph> <paragraph num="(b)"> <text>As specified as a preference by the health care consumer under Regulation .03H of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If there is insufficient or out-of-date contact information that precludes notice consistent with this chapter, a substitute form of notice shall be provided. A substitute form of notice may include publishing the notice on the home page of the entity's website to the extent permitted by HIPAA and other federal and State privacy laws.</text> </paragraph> <paragraph num="(4)"> <text>When notice about a breach or non-HIPAA violation is required pursuant to this chapter, a participating organization or an HIE, as required, shall notify a health care consumer in writing within a reasonable time frame, but not later than 60 days from the discovery of the breach or from the date that the HIE should have reasonably discovered the breach.</text> </paragraph> <paragraph num="(5)"> <text>The written notification shall include:</text> <paragraph num="(a)"> <text>A description of the breach or non-HIPAA violation that occurred and the remedial actions taken by the participating organization, provided that the notification shall not contain any sensitive health information;</text> </paragraph> <paragraph num="(b)"> <text>Information about the patient's right to notify credit reporting agencies of the potential for identity theft or medical identity theft;</text> </paragraph> <paragraph num="(c)"> <text>Contact information for the HIE, including the address and toll-free telephone number where the health care consumer can learn more information;</text> </paragraph> <paragraph num="(d)"> <text>Contact information for at least one credit reporting agency;</text> </paragraph> <paragraph num="(e)"> <text>Information concerning the patient's right to opt out of the HIE; and</text> </paragraph> <paragraph num="(f)"> <text>The toll-free numbers, addresses, and websites for:</text> <paragraph num="(i)"> <text>The Office of the Attorney General, Consumer Protection Division; and</text> </paragraph> <paragraph num="(ii)"> <text>The U.S. Department of Health and Human Services, Office of Civil Rights.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the entity providing the notification keeps a medical record on the patient, the notification shall be placed within the patient's medical record.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Notification to Appropriate Authorities.</text> <paragraph num="(1)"> <text>Each participating organization and each HIE shall report all violations of federal or State privacy or security law to:</text> <paragraph num="(a)"> <text>Those federal or State authorities to which reporting such violation is required by applicable law, whether or not such laws are specifically set forth in this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Shall promptly send a copy of such report to the Commission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Commission is notified of a breach under this regulation, it shall forward such notification to the Office of the Attorney General, Consumer Protection Division, within 30 days after receipt of the notification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Registration and Enforcement."> <paragraph num="A."> <text>To operate an HIE in the State, a person shall be recognized by the Commission as having met requirements for registration.</text> <paragraph num="(1)"> <text>A person shall complete an application for registration in a form and manner specified by the Commission that shall include:</text> <paragraph num="(a)"> <text>The HIE's definition of what constitutes an unusual finding within Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>The HIE's current audited financial statement that demonstrates the financial viability of the HIE;</text> </paragraph> <paragraph num="(c)"> <text>The identity of the HIE's registered resident agent who shall accept service in Maryland on behalf of the HIE;</text> </paragraph> <paragraph num="(d)"> <text>Documentation showing its technical capabilities, which may include accreditation or candidacy status by a nationally recognized accrediting body; and</text> </paragraph> <paragraph num="(e)"> <text>Provisions for reasonable notice to participating organizations and the Commission if the HIE ceases to operate in Maryland; and</text> </paragraph> <paragraph num="(f)"> <text>Other information as required by the Commission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Financial Integrity.</text> <paragraph num="(a)"> <text>Following review of the financial statement provided by the HIE under §A(1)(b) of this regulation, the Commission may require a bond, letter of guarantee, or other financial instrument from the HIE, its parent company, or other responsible person.</text> </paragraph> <paragraph num="(b)"> <text>The amount of a bond, letter of guarantee, or other financial instrument required under this regulation shall be established by the Commission and be based on an HIE's financial statement.</text> </paragraph> <paragraph num="(c)"> <text>If a bond is required under §A(2)(a) of this regulation, it shall at a minimum:</text> <paragraph num="(i)"> <text>Identify the Commission as the sole beneficiary;</text> </paragraph> <paragraph num="(ii)"> <text>Be continuous and subject to cancellation only after 60 days' notice to the Commission;</text> </paragraph> <paragraph num="(iii)"> <text>Contain the following language or similar language acceptable to the Commission: “Payment under this bond shall be due in the event the Commission determines that the HIE is financially insolvent or unable to meet its obligations as a registered HIE in Maryland”; and</text> </paragraph> <paragraph num="(iv)"> <text>Permit the Commission to direct that the proceeds of the bond be paid or disbursed as necessary to maintain or repair the privacy and security of PHI that was or is available through the HIE.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If a bond is required under §A(2)(a) of this regulation, it shall be obtained from a company licensed in the State to write surety types of insurance.</text> </paragraph> <paragraph num="(e)"> <text>If a letter of guarantee or other financial instrument is required under §A(2)(a) of this regulation, the guarantor shall submit a current balance sheet and income statement to the Commission.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 45 days after receipt of complete information from an applicant seeking to register as an HIE in the State, the Commission shall take one of the following actions:</text> <paragraph num="(a)"> <text>Recognize the HIE as registered in the State; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the registration for reasons enumerated to the applicant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission shall annually renew the registration of an HIE registered in the State that demonstrates its continued compliance with this chapter and provides the following information in a form and manner specified by the Commission, within 120 days of the close of its fiscal year:</text> <paragraph num="(1)"> <text>Updated information that reflects each change regarding the items in §A(1) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Results of an audit performed in compliance with Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>As deemed appropriate by the Commission, additional requirements set forth in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Other information as requested by the Commission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission may take an enforcement action against a person when there is reasonable basis to believe that the person has violated a provision of this chapter.</text> <paragraph num="(1)"> <text>The Commission may conduct any investigation into a potential violation.</text> <paragraph num="(a)"> <text>A person shall cooperate in an investigation conducted by Commission staff into a potential violation.</text> </paragraph> <paragraph num="(b)"> <text>A person shall provide information sought by Commission staff within 10 business days of its request for such information, unless an extension of time is sought for good cause shown and granted by the Commission.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After an investigation under §C(1) of this regulation, the Commission staff may issue a notice of proposed action that includes:</text> <paragraph num="(a)"> <text>The details regarding each violation or potential violation;</text> </paragraph> <paragraph num="(b)"> <text>A request for a person to submit a corrective action plan in order to achieve compliance with this chapter, which may include:</text> <paragraph num="(i)"> <text>An action aimed at correcting the underlying issue; and</text> </paragraph> <paragraph num="(ii)"> <text>Any other action that is appropriate under the circumstances.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A recommended resolution of the potential violation, which may include:</text> <paragraph num="(i)"> <text>Non-public reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Public reprimand; or</text> </paragraph> <paragraph num="(iii)"> <text>Limitations on HIE registration or a person's access to information through an HIE;</text> </paragraph> <paragraph num="(iv)"> <text>Suspension of HIE registration or a person’s access to information through an HIE;</text> </paragraph> <paragraph num="(v)"> <text>Revocation of HIE registration or a person’s access to information through an HIE;</text> </paragraph> <paragraph num="(vi)"> <text>Financial penalties in accordance with §C(3) of this regulation; or</text> </paragraph> <paragraph num="(vii)"> <text>Referral to another State or federal agency for civil or criminal enforcement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Civil and Criminal Penalties.</text> <paragraph num="(a)"> <text>Civil Penalties. A person who knowingly fails to comply with this chapter shall be subject to a civil penalty imposed by the Commission not exceeding $10,000 per day based on:</text> <paragraph num="(i)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(ii)"> <text>The cost of the investigation; and</text> </paragraph> <paragraph num="(iii)"> <text>The person’s prior record of compliance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Criminal Penalties. Beginning June 1, 2024, a person who knowingly violates Health-General Article, §4-302.5, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to a fine not to exceed $10,000 per day based on:</text> <paragraph num="(i)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(ii)"> <text>The cost of the investigation; and</text> </paragraph> <paragraph num="(iii)"> <text>The person’s prior record of compliance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>When the Commission staff determines that a notice of proposed action is not appropriate given the lack of available evidence or other circumstances, it may issue one of the following:</text> <paragraph num="(a)"> <text>A letter advising that no action is recommended at that time; or</text> </paragraph> <paragraph num="(b)"> <text>A letter finding that no action is warranted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A person who receives a notice of proposed action from the Commission staff may request an opportunity to show cause why the proposed action should not be taken.</text> <paragraph num="(1)"> <text>A written request to show cause shall be filed with the Commission and shall comply with the following:</text> <paragraph num="(a)"> <text>It shall be filed within 20 days of the issuance of the notice of proposed action; and</text> </paragraph> <paragraph num="(b)"> <text>It shall include each fact upon which the person relies to show cause why the proposed action should not be taken.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon receipt of a request to show cause, the Commission staff may meet with the person to attempt to resolve the matter in a manner that protects the public and is in the public interest.</text> </paragraph> <paragraph num="(3)"> <text>If a notice of proposed action is not resolved within 45 days of the filing of a request to show cause, a hearing officer shall be designated by the executive director of the Commission.</text> <paragraph num="(a)"> <text>The hearing officer shall hear evidence as needed;</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be conducted in accordance with the Maryland Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland, and these regulations.</text> </paragraph> <paragraph num="(c)"> <text>The hearing officer shall issue a recommended decision that contains proposed findings of fact and conclusions of law and may recommend that the Commission take one of the following actions:</text> <paragraph num="(i)"> <text>Adopt the action proposed by Commission staff;</text> </paragraph> <paragraph num="(ii)"> <text>Adopt a proposed action recommended by the hearing officer; or</text> </paragraph> <paragraph num="(iii)"> <text>Find that no action is warranted.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A request that the Commission not adopt the recommended decision may be made by either Commission staff or a person who is the subject of an enforcement action.</text> <paragraph num="(1)"> <text>Written exceptions to the recommended decision shall be filed within 20 days of receipt of the hearing officer's recommended decision.</text> </paragraph> <paragraph num="(2)"> <text>Exceptions shall specifically identify in writing each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based.</text> </paragraph> <paragraph num="(3)"> <text>A written response to exceptions to the recommended decision may be filed by an opposing party within 15 days of receipt of exceptions.</text> </paragraph> <paragraph num="(4)"> <text>Each person taking or responding to exceptions may present oral argument to the Commission, not to exceed 10 minutes per party, unless extended by the Chair of the Commission.</text> </paragraph> <paragraph num="(5)"> <text>The decision of the Commission shall be by a majority of the quorum present and voting.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Commission may coordinate with the Office of Attorney General concerning any potential violation involving a matter within the Attorney General’s authority pursuant to State or federal law.</text> </paragraph> <paragraph num="G."> <text>If an HIE has reasonably determined that it is unable to independently meet any requirements of this chapter, then the HIE shall develop and implement policies to ensure the HIE’s compliance through the execution of a written agreement with a participating organization or a business associate that will bring the HIE into compliance with this chapter. Every year as a part of the registration renewal process, the HIE shall submit a written attestation by an independent third-party auditor to the Commission, attesting that the HIE has been in full compliance with the requirements of this chapter for the 12-month period prior to the audit.</text> </paragraph> <paragraph num="H."> <text>Exemptions.</text> <paragraph num="(1)"> <text>An HIE may request a 1-year exemption from certain requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>An exemption request must:</text> <paragraph num="(a)"> <text>Be in writing;</text> </paragraph> <paragraph num="(b)"> <text>Identify each specific requirement of this chapter from which the HIE is requesting an exemption;</text> </paragraph> <paragraph num="(c)"> <text>Identify the time period of the exemption, if any;</text> </paragraph> <paragraph num="(d)"> <text>State the reason for each exemption request; and</text> </paragraph> <paragraph num="(e)"> <text>Include information that justifies the exemption request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 45 days after receipt of complete information from an HIE requesting an exemption, the Commission shall take one of the following actions:</text> <paragraph num="(a)"> <text>Grant the exemption by providing written notification; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the exemption request by providing written notification that enumerates the reasons for the denial to the HIE.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An exemption may not be made for any requirement within this chapter that is otherwise required of the HIE by federal or other State law.</text> </paragraph> <paragraph num="(5)"> <text>An exemption may be made on the following grounds:</text> <paragraph num="(a)"> <text>The absence of certain functionality in the infrastructure of the HIE that does not allow the HIE to maintain compliance with the requirement;</text> </paragraph> <paragraph num="(b)"> <text>The requirement would hinder the ability of the HIE to comply with other requirements of this chapter or federal or other State laws; or</text> </paragraph> <paragraph num="(c)"> <text>The requirement would cause an undue burden or hardship on the HIE, such that the HIE would no longer be able to provide HIE services in the State.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>For good cause shown, the Commission may renew a 1-year exemption for an additional 1-year period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Requirements for Accessing, Using, or Disclosing of Data Through an HIE for Secondary Use."> <paragraph num="A."> <text>An HIE may not use or disclose a patient’s sensitive health information for secondary use unless permitted by applicable federal or State laws and regulations.</text> </paragraph> <paragraph num="B."> <text>Population Health Management.</text> <paragraph num="(1)"> <text>An HIE may disclose de-identified data or a limited data set, as defined at 45 CFR §164.514(e), to a care management organization for purposes related to population health management, if approval is obtained from an internal review committee designated by the care management organization, which has:</text> <paragraph num="(a)"> <text>Entered into a data use agreement with the HIE; and</text> </paragraph> <paragraph num="(b)"> <text>Attested that the request is:</text> <paragraph num="(i)"> <text>For population health management purposes; and</text> </paragraph> <paragraph num="(ii)"> <text>Limited to the minimum necessary to complete the function.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE may disclose individually identifiable health information to a care management organization for purposes related to population health management, if:</text> <paragraph num="(a)"> <text>The requirements of §B(1) of this regulation are met;</text> </paragraph> <paragraph num="(b)"> <text>Appropriate notice has been provided to health care consumers whose information is being requested, and either:</text> <paragraph num="(i)"> <text>The health care consumers have authorized the release of their information to the requesting entity; or</text> </paragraph> <paragraph num="(ii)"> <text>An external and independent review committee has waived the need for the requesting entity to obtain authorization from those health care consumers who were provided appropriate notice, in accordance with Regulation .02B(4) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The disclosure is consistent with the authorization.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Any external and independent review committee identified by the care management organization may approve an authorization waiver request where the requesting care management organization has demonstrated that:</text> <paragraph num="(a)"> <text>Appropriate notice to each health care consumer was provided and no authorization or denial of authorization was received from each health care consumer within the 30-day time frame;</text> </paragraph> <paragraph num="(b)"> <text>The objectives for which the data was requested could not be met without access to the requested data; and</text> </paragraph> <paragraph num="(c)"> <text>The requested use or disclosure involves no more than minimal risk to the privacy of those health care consumers whose authorization will be waived based on the presence of attributes that include, at a minimum:</text> <paragraph num="(i)"> <text>An adequate plan presented to the external and independent review committee to protect PHI from improper use, storage, and disclosure in accordance with current legal requirements and industry standards and practices as determined by the external and independent review committee;</text> </paragraph> <paragraph num="(ii)"> <text>An adequate plan to destroy the PHI when the purposes for which it has been requested are completed, unless such retention is authorized under the waiver or otherwise required by law; and</text> </paragraph> <paragraph num="(iii)"> <text>Adequate written assurances that the PHI will not be reused or disclosed to any person or entity, except as authorized under the waiver, as required or permitted by law, or for authorized oversight of the use.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>An HIE may not disclose a patient’s sensitive health information for population health management purposes unless permitted by applicable federal and State laws and regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Research.</text> <paragraph num="(1)"> <text>An HIE may disclose de-identified data to a qualified research organization for research purposes if a privacy board has evaluated and confirmed that the:</text> <paragraph num="(a)"> <text>Requesting entity is a qualified research organization; and</text> </paragraph> <paragraph num="(b)"> <text>Requested data to be disclosed:</text> <paragraph num="(i)"> <text>Is for purposes related to research;</text> </paragraph> <paragraph num="(ii)"> <text>Is limited to the minimum necessary to complete the research purpose;</text> </paragraph> <paragraph num="(iii)"> <text>Will be used to serve a legitimate purpose consistent with the interest of the subject individuals; and</text> </paragraph> <paragraph num="(iv)"> <text>Meets the de-identification standard and specifications in accordance with 45 CFR §164.514(a)—(c).</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An HIE may disclose individually identifiable health information to a qualified research organization for research purposes if:</text> <paragraph num="(a)"> <text>Approval is obtained from an IRB or privacy board in accordance with 45 CFR §164.512, including documentation of waiver approval as detailed in 45 CFR §164.512(i)(2); and</text> </paragraph> <paragraph num="(b)"> <text>The IRB or privacy board has evaluated the request and confirmed that the requirements of §C(1)(a) and (b)(i)—(iii) of this regulation are met.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an IRB or privacy board does not waive or alter the requirement of authorization from health care consumers whose individually identifiable health information is to be disclosed, an HIE may only disclose individually identifiable health information of health care consumers who have provided authorization, which must meet the requirements as set forth in 45 CFR §164.508.</text> </paragraph> <paragraph num="(4)"> <text>If an IRB or privacy board declines jurisdiction, then the disclosure of individually identifiable health information may only be made if health care consumer authorization is obtained.</text> </paragraph> <paragraph num="(5)"> <text>As part of an HIE’s data use agreement with an entity to which it disclosed individually identifiable health information for secondary use, there shall be oversight by an IRB or privacy board for the duration of the research use.</text> </paragraph> <paragraph num="(6)"> <text>If an IRB or privacy board determines that the qualified research organization has failed to use or protect the data in accordance with the approved secondary use, the IRB or privacy board must report its findings to the HIE and the HIE must:</text> <paragraph num="(a)"> <text>Report the findings to federal and State agencies with jurisdiction over the violation, as deemed appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Immediately terminate the data use agreement; and</text> </paragraph> <paragraph num="(c)"> <text>Direct the qualified research organization to destroy the data previously released by the HIE and attest that the data has been destroyed.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The qualified research organization receiving data from an HIE for research purposes:</text> <paragraph num="(a)"> <text>Must contractually agree not to attempt to link de-identified data received from the HIE with other data sources in an effort to re-identify the data, or otherwise attempt in any other way to re-identify the data; and</text> </paragraph> <paragraph num="(b)"> <text>May disclose data to a third party acting on behalf of the qualified research organization only if the qualified research organization and third party enter into a data use agreement that requires the third party to be bound by the same provisions in the data use agreement between the HIE and qualified research organization.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>An HIE may charge a reasonable fee to a qualified research organization to which it discloses data for research, which fee must reflect the effort and be no greater than the actual direct and indirect costs required to prepare and release the data specific to the purpose authorized.</text> </paragraph> <paragraph num="(9)"> <text>An HIE may not disclose a patient’s sensitive health information for research purposes unless permitted by applicable federal or State laws and regulations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Enforcement and Reporting.</text> <paragraph num="(1)"> <text>An HIE is not required to take legal or equitable action to enforce the requirements of the data use agreement or of any other contractual assurance provided for in Regulation .05C of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>An HIE shall make summary reports available to the public quarterly that provide specific information about requests for data for secondary use and the release of data for secondary purposes.</text> </paragraph> <paragraph num="(3)"> <text>An HIE shall report at least annually to the Commission and more frequently, if requested by the Commission, regarding the release of information for population health management. The Commission may:</text> <paragraph num="(a)"> <text>Require a care management organization to provide additional information for review by the Commission or the Commission’s designated third party regarding the care management organization’s use of data from an HIE for population health management;</text> </paragraph> <paragraph num="(b)"> <text>Require the HIE to conduct an audit of the disclosure and use of the data utilizing a third-party auditor at the expense of either the recipient of the data or the HIE, as determined by Commission;</text> </paragraph> <paragraph num="(c)"> <text>Require the receiving entity to destroy the data received and cease any further use of the data; or</text> </paragraph> <paragraph num="(d)"> <text>Prohibit an HIE from releasing data for all or certain secondary data use purposes.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An HIE shall, upon the request by a health care consumer, provide an accounting of any disclosures made to a receiving entity for secondary data use purposes, in accordance with Regulation .03C(4) of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Requirements for Accessing, Using, or Disclosing of Data Through an HIE in an Emergency."> <paragraph num="A."> <text>An HIE shall develop and implement emergency access policies and procedures that satisfy the following requirements:</text> <paragraph num="(1)"> <text>The policies and procedures shall be included in the HIEs health care consumer education materials required by Regulation .03B(1) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Clearly communicate the following:</text> <paragraph num="(a)"> <text>The extent to which the HIE has the capability to disclose the patient's information in an emergency and how this compares to disclosure for routine access; and</text> </paragraph> <paragraph num="(b)"> <text>The circumstances under which the HIE would disclose the patient's information in an emergency, including how opting in or out of participation would impact access to the patient's information during an emergency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If an HIEs emergency access policy allows the disclosure of information during an emergency, the HIE shall:</text> <paragraph num="(1)"> <text>Only disclose information to the requesting health care provider if the following conditions are met:</text> <paragraph num="(a)"> <text>The requesting health care provider:</text> <paragraph num="(i)"> <text>Advises the HIE that it is the health care provider's professional opinion that an emergency exists; and</text> </paragraph> <paragraph num="(ii)"> <text>Attests that all conditions of the participating organization's policy have been met;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The patient's condition preclude the participating organization from obtaining the consent of the health care consumer;</text> </paragraph> <paragraph num="(c)"> <text>Information available through the HIE may be relevant to the treatment needed by the patient in the specific emergency;</text> </paragraph> <paragraph num="(d)"> <text>The participating organization has an established policy that describes the requirements and attestation process for emergency access; and</text> </paragraph> <paragraph num="(e)"> <text>Disclosure of information available through the HIE is not in violation of applicable federal and State laws and regulations related to sensitive health information.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Establish technical procedures for documenting an attestation by the requesting health care provider that the conditions in §B(1) of this regulation, were met prior to accessing information through the HIE;</text> </paragraph> <paragraph num="(3)"> <text>Review the emergency access logs at least monthly, in coordination with the participating organization, to identify any unusual finding;</text> </paragraph> <paragraph num="(4)"> <text>Take action in accordance with Regulation .06 of this chapter, in the event the emergency access log reveals an unusual finding;</text> </paragraph> <paragraph num="(5)"> <text>Maintain an audit trail of user emergency access logs in accordance with Regulation .06A(8) of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Require a participating organization to:</text> <paragraph num="(a)"> <text>Access only the minimum necessary information needed to care for the patient during the emergency encounter;</text> </paragraph> <paragraph num="(b)"> <text>Discontinue querying of the patient's record upon the completion of the emergency encounter;</text> </paragraph> <paragraph num="(c)"> <text>Allow emergency access only to authorized users with the appropriate access designation consistent with the policy of the participating organization; and</text> </paragraph> <paragraph num="(d)"> <text>Notify the health care consumer, as soon as reasonably possible, and no later than ten business days from the initial access, when the HIE has granted access to the health care consumer's information during an emergency.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Requirements for Providing Health Care Consumers Electronic Access to Their Health Information."> <paragraph num="A."> <text>An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their health information shall:</text> <paragraph num="(1)"> <text>Appropriately verify the identity of the health care consumer requesting electronic access or proposing an addition or change to the patient’s information available through the HIE prior to disclosing or accepting changes to the information;</text> </paragraph> <paragraph num="(2)"> <text>Follow, at a minimum, the National Institute of Standards and Technology (NIST) Level 2 registration and identity proofing requirements as outlined in the most recent version of Special Publication 800-63: Electronic Authentication Guideline or its comparable industry best practices and may perform remote identity proofing;</text> </paragraph> <paragraph num="(3)"> <text>Implement the health care consumer’s authorization for access within a maximum of 5 business days of receipt of all necessary information for identity proofing;</text> </paragraph> <paragraph num="(4)"> <text>Adopt and implement authentication processes for health care consumer electronic access that is in accordance with Regulation .05D(3) and (4) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Establish individual unique user names and passwords in accordance with the most recent applicable standards issued by NIST, or other comparable standards generally adopted by the health care and HIE industry;</text> </paragraph> <paragraph num="(6)"> <text>Implement processes for auditing health care consumer access that are in compliance with applicable requirements of Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Implement a process for suspending and reinstating a health care consumer’s access in compliance with applicable requirements in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Establish processes and procedures to allow a patient to authorize an individual to have electronic access to their information;</text> </paragraph> <paragraph num="(9)"> <text>Establish processes and procedures that allow an individual to electronically access health information for a patient or patients:</text> <paragraph num="(a)"> <text>For whom the individual has legal authorization for such access (e.g., guardian, person with a medical power of attorney, etc.); or</text> </paragraph> <paragraph num="(b)"> <text>For whom the patient has authorized such access;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Establish processes and procedures to confirm the authority of a person in interest, if not directly authorized by a patient, which must be satisfied as a condition to providing access to that person in interest; and</text> </paragraph> <paragraph num="(11)"> <text>Comply with applicable federal and State laws and regulations related to sensitive health information when disclosing such information to a health care consumer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their information may:</text> <paragraph num="(1)"> <text>Charge a reasonable cost-based published fee for healthcare consumer electronic access consistent with applicable federal and State laws; and</text> </paragraph> <paragraph num="(2)"> <text>Deny a health care consumer’s electronic access in accordance with:</text> <paragraph num="(a)"> <text>Applicable law or regulation, including 45 CFR §164.524, in coordination with applicable participating organizations; or</text> </paragraph> <paragraph num="(b)"> <text>The HIE’s reasonable policies, procedures, or agreements with a participating organization and shall provide notice to the health care consumer of their right to request access to the patient’s health information from the covered entity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An HIE or its third party that offers health care consumer electronic access to view the patient’s health information available through the HIE shall, in accordance with federal and State law:</text> <paragraph num="(1)"> <text>Provide the patient’s health information that is equivalent to what is made available to authorized users that are health care providers, which may include:</text> <paragraph num="(a)"> <text>Demographic information, such as name, address, and date of birth;</text> </paragraph> <paragraph num="(b)"> <text>Provider encounters or procedures performed (e.g., hospital, ambulatory, post-acute care, etc.);</text> </paragraph> <paragraph num="(c)"> <text>Immunizations;</text> </paragraph> <paragraph num="(d)"> <text>Visit summaries;</text> </paragraph> <paragraph num="(e)"> <text>Care plan(s);</text> </paragraph> <paragraph num="(f)"> <text>Clinical test results; and</text> </paragraph> <paragraph num="(g)"> <text>Prescriptions;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At a minimum, and if made available through the HIE, make the following data attributes for the patient’s health information electronically available to the health care consumer:</text> <paragraph num="(a)"> <text>Date of the encounter, procedure, test, prescription, or immunization;</text> </paragraph> <paragraph num="(b)"> <text>Results or summary of the encounter, procedure, test, prescription, or immunization; and</text> </paragraph> <paragraph num="(c)"> <text>Source of the health information, including provider name and organization name;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Inform health care consumers regarding:</text> <paragraph num="(a)"> <text>Contacting their health care provider to discuss the health information they may be viewing if they have any concerns or questions; and</text> </paragraph> <paragraph num="(b)"> <text>Translation services and resources that may be available, through the HIE or another entity, to help assist the health care consumer in understanding their health information; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Allow the health care consumer to view the patient’s health information in an electronic format that meets the following criteria:</text> <paragraph num="(a)"> <text>The information is presented in substantially the same form and format as presented to an authorized user that is a health care provider;</text> </paragraph> <paragraph num="(b)"> <text>The form and format presented to a health care consumer is easy for the health care consumer to navigate;</text> </paragraph> <paragraph num="(c)"> <text>The information can be easily printed; and</text> </paragraph> <paragraph num="(d)"> <text>If supplemental information is made available along with the patient’s health information, such as educational resources, the supplemental information meets the criteria specified in Regulation .03B(2)(c)—(e) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An HIE or its third party that offers health care consumers the ability to electronically control the patient’s health information being made available through the HIE shall:</text> <paragraph num="(1)"> <text>Implement technology processes that meet industry standards and best practices and are in compliance with State and federal privacy and security laws; and</text> </paragraph> <paragraph num="(2)"> <text>Provide an electronic process by which a health care consumer can control the patient’s health information that is in accordance with §C(4)(b)—(d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An HIE or its third party that offers health care consumers the ability to download the patient’s health information being made available through the HIE shall provide the patient’s health information that is:</text> <paragraph num="(1)"> <text>In accordance with §C(3) and (4)(b)—(d) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Requested by the health care consumer; and</text> </paragraph> <paragraph num="(3)"> <text>In a readily available industry standard format.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An HIE or its third party that offers health care consumers the ability to submit information to the HIE:</text> <paragraph num="(1)"> <text>Shall identify the source of the information, such as patient, payor, or health care provider, when presented to an authorized user of the HIE; and</text> </paragraph> <paragraph num="(2)"> <text>May not use patient submitted health information to override or replace health information submitted from other sources.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An HIE or its third party that offers health care consumers the ability to transmit the patients’ health information being made available through the HIE to a third party of the health care consumer’s designation shall comply with the requirements as detailed in:</text> <paragraph num="(1)"> <text>§C(3) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>§C(4)(b) and (d) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>§E(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Health Care Consumer Education About Electronic Access.</text> <paragraph num="(1)"> <text>An HIE shall provide needed information, as part of its health care consumer education plan (as detailed in .03B(1) of this chapter and meeting the characteristics as detailed in Regulation .03B(2) of this chapter), about the services or features offered by the HIE or its third party that allows the health care consumer to electronically view, download, submit, or control the patient’s information that is available through the HIE.</text> </paragraph> <paragraph num="(2)"> <text>The health care consumer education plan shall outline the process which, if available, allows a health care consumer to electronically view, download, transmit, submit, or control the patient’s information that is available through the HIE, including:</text> <paragraph num="(a)"> <text>The information the health care consumer must provide as part of patient identity proofing;</text> </paragraph> <paragraph num="(b)"> <text>The patient’s rights to:</text> <paragraph num="(i)"> <text>Authorize a person in interest or individual to also have access to the patient’s health information; and</text> </paragraph> <paragraph num="(ii)"> <text>Request a review of a denial of access;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The extent to which the health care consumer has control of the patient’s health information being made available through the HIE; and</text> </paragraph> <paragraph num="(d)"> <text>The need to safeguard information obtained from the HIE to the same extent they safeguard other sensitive personal information.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Noncontrolled Prescription Drugs Dispenser Reporting."> <paragraph num="A."> <text>For each noncontrolled prescription drug dispensed, the dispenser shall report drug information to the State-designated HIE in accordance with this regulation.</text> </paragraph> <paragraph num="B."> <text>MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.</text> <paragraph num="(1)"> <text>The Commission shall develop a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall approve a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual by June 1 of each year to be used for reporting by the last business day of September of the same calendar year.</text> </paragraph> <paragraph num="(3)"> <text>The MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual shall minimally:</text> <paragraph num="(a)"> <text>Specify the data and prescription drug information that must be submitted by dispensers to the State-designated HIE in accordance with this regulation, including specifying the American Society for Automation in Pharmacy (ASAP) standard;</text> </paragraph> <paragraph num="(b)"> <text>Specify the timeframe and frequency of data submissions to the State-designated HIE;</text> </paragraph> <paragraph num="(c)"> <text>Require a dispenser to report data elements consistent with the ASAP standard identified in MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual;</text> </paragraph> <paragraph num="(d)"> <text>Include electronic reporting specifications, encryption algorithms, file layout, and the process for dispensers who are unable to submit data due to mechanical, electrical, or other technical failure; and</text> </paragraph> <paragraph num="(e)"> <text>Align, to the extent possible, with the Maryland Prescription Drug Monitoring Program Data Submitter User Guide.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Commission shall publish a draft Noncontrolled Prescription Drugs Dispenser Data Submission Manual on the Commission’s website and in the Maryland Register at least 30 days before the public meeting at which the Commission shall consider the manual for final approval and provide at least 20 days for the submission of public comment.</text> </paragraph> <paragraph num="(5)"> <text>The Commission shall consider all comments received before final approval of the Noncontrolled Prescription Drugs Dispenser Data Submission Manual.</text> </paragraph> <paragraph num="(6)"> <text>The Commission shall publish the final MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual on its website within 5 days of its approval.</text> </paragraph> <paragraph num="(7)"> <text>The State-designated HIE shall post a link to MHCC’s Noncontrolled Prescription Drugs Dispenser Data Submission Manual prominently on its website.</text> </paragraph> <paragraph num="(8)"> <text>The Commission may correct incomplete or erroneous information in the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual as necessary and shall provide notice of each correction:</text> <paragraph num="(a)"> <text>On its website; and</text> </paragraph> <paragraph num="(b)"> <text>By email to the designated dispenser contact person.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Means of Data Submission and Data Format. A dispenser shall transmit noncontrolled prescription drug information to the State-designated HIE:</text> <paragraph num="(1)"> <text>Consistent with the requirements detailed in the most recent version of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual;</text> </paragraph> <paragraph num="(2)"> <text>By use of an encrypted electronic transmission method or a secure electronic reporting form; and</text> </paragraph> <paragraph num="(3)"> <text>In a format or utilizing data standards approved by the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reporting Deadline.</text> <paragraph num="(1)"> <text>Unless granted a waiver under §F of this regulation, a dispenser shall report to the State-designated HIE:</text> <paragraph num="(a)"> <text>The noncontrolled prescription drug information required by the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual no later than the end of the next day of operation after the prescription is dispensed; or</text> </paragraph> <paragraph num="(b)"> <text>A zero report no later than the end of the next day of operation after a day without dispenses of noncontrolled prescription drugs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report non-controlled prescription data electronically shall:</text> <paragraph num="(a)"> <text>Notify the State-designated HIE by a communication method approved by the State-designated HIE within 24 hours of discovery of the technical failure; and</text> </paragraph> <paragraph num="(b)"> <text>Submit a report for each noncontrolled prescription drug dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Acceptance and Disclosure of Noncontrolled Prescription Drug Information by the State-designated HIE.</text> <paragraph num="(1)"> <text>The State-designated HIE shall:</text> <paragraph num="(a)"> <text>Electronically collect noncontrolled prescription drug information from dispensers;</text> </paragraph> <paragraph num="(b)"> <text>Not impose any fees or other assessments on dispensers to support its operation;</text> </paragraph> <paragraph num="(c)"> <text>Make information technology available for dispensers to report noncontrolled prescription drug information to the State-designated HIE; and</text> </paragraph> <paragraph num="(d)"> <text>Retain noncontrolled prescription drug information collected pursuant to this section for at least 5 years from the date of receipt, except for the PHI of patients who opt-out of an HIE consistent with Regulation.03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The State-designated HIE may reject data submitted by dispensers that does not comply with the requirements of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.</text> </paragraph> <paragraph num="(3)"> <text>If the State-designated HIE rejects the data submitted by a dispenser, the dispenser shall correct and resubmit the data no later than 7 business days after receiving notification from the State-designated HIE of receipt of incomplete or inaccurate data.</text> </paragraph> <paragraph num="(4)"> <text>Beginning January 1, 2026, the State-designated HIE shall make patient-specific prescription information submitted by dispensers under this section available for purposes allowed under applicable law.</text> </paragraph> <paragraph num="(5)"> <text>Upon written request for public health purposes and as allowed by applicable law, the State-designated HIE shall provide data collected under this regulation within 5 days to the Maryland Department of Health, local health departments, the Commission, or the Health Services Cost Review Commission.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Dispenser Waiver Request Process.</text> <paragraph num="(1)"> <text>Prior to September 1, 2025, dispensers of noncontrolled prescription drug information are exempt from reporting dispensed information to the State-designated HIE.</text> </paragraph> <paragraph num="(2)"> <text>A dispenser that dispenses noncontrolled prescription drugs may seek a waiver from the Commission of the requirements in this regulation based on:</text> <paragraph num="(a)"> <text>Economic hardship;</text> </paragraph> <paragraph num="(b)"> <text>Technology limitations that are not reasonably within the dispenser’s control;</text> </paragraph> <paragraph num="(c)"> <text>Dispensing less than 100 noncontrolled prescription drugs annually; or</text> </paragraph> <paragraph num="(d)"> <text>Other circumstances determined by the Commission to be extenuating.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A request for a waiver shall be in writing and shall include:</text> <paragraph num="(a)"> <text>A detailed explanation of the need for the waiver;</text> </paragraph> <paragraph num="(b)"> <text>An attestation as to the accuracy of the information in the waiver request; and</text> </paragraph> <paragraph num="(c)"> <text>An attestation that the dispenser shall immediately inform the Commission if the circumstances necessitating a waiver no longer exist.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Within 45 days after receipt of complete information from a dispenser requesting a waiver, the Commission shall:</text> <paragraph num="(a)"> <text>Grant a time-limited waiver request; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the waiver request, with an explanation that enumerates the reasons for the denial.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A dispenser shall inform the Commission and immediately begin reporting in compliance with this regulation if the dispenser no longer meets the conditions of a waiver request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Operation of the State-designated HIE as a Health Data Utility."> <paragraph num="A."> <text>The State-designated HIE shall operate as a health data utility for the State.</text> </paragraph> <paragraph num="B."> <text>The State-designated HIE shall implement a consent management application in accordance with Regulation .03D of this chapter.</text> </paragraph> <paragraph num="C."> <text>Disclosures by the State-designated HIE.</text> <paragraph num="(1)"> <text>Except as otherwise prohibited under this chapter or State or federal law, the State-designated HIE shall transmit clinical information or electronic health care transactions to the Maryland Department of Health, the Commission, or the Health Services Cost Review Commission for public health purposes upon written request.</text> </paragraph> <paragraph num="(2)"> <text>The State-designated HIE may not redisclose financial information in electronic health care transactions it receives in accordance with COMAR 10.25.07.09 to any person other than the Commission.</text> </paragraph> <paragraph num="(3)"> <text>Maryland Medical Care Data Base.</text> <paragraph num="(a)"> <text>The State-designated HIE shall be designated as a reporting entity to the Maryland Medical Care Data Base.</text> </paragraph> <paragraph num="(b)"> <text>The State-designated HIE shall report the electronic health care transactions information it receives pursuant to COMAR 10.25.07.09 to the Medicare Care Data Base in accordance with the reporting requirements found in COMAR 10.25.06.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The State-designated HIE shall:</text> <paragraph num="(a)"> <text>Develop a process in which requests for data are submitted and data are shared, and post this information on its website; and</text> </paragraph> <paragraph num="(b)"> <text>Provide a written explanation for a denial of a request which shall include an appeal process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The State-designated HIE shall consult with the Maryland Department of Health, the Commission, and Health Services Cost Review Commission before identifying any specific purposes, type of data exchanged, and rules for interaction between users and the State-designated HIE pertaining to:</text> <paragraph num="(1)"> <text>A State health improvement program;</text> </paragraph> <paragraph num="(2)"> <text>Mitigation of a public health emergency;</text> </paragraph> <paragraph num="(3)"> <text>Improvement of patient safety; and</text> </paragraph> <paragraph num="(4)"> <text>Any other public health priorities identified by the Secretary.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Consumer Advisory Council.</text> <paragraph num="(1)"> <text>The State-designated HIE shall establish a Consumer Advisory Council in accordance with Health-General Article, §19-145, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The State-designated HIE shall:</text> <paragraph num="(a)"> <text>Appoint two consumer representatives identified by the Commission who have significant experience in public health and patient privacy as council members;</text> </paragraph> <paragraph num="(b)"> <text>Post advance notice of council meetings on its website, including an expected agenda; and</text> </paragraph> <paragraph num="(c)"> <text>Require the Consumer Advisory Council to comply with the requirements of the Maryland Open Meetings Act as if it were a public body.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-301, 4-302.2, 4-302.3, 4-302.5, 4-304, 19-103, 19-109(a)(1) and (8), 19-133, 19-143, and 19-145, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 17, 2014 (41:5 Md. R. 344)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A,B amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 13, 2018 (45:16 Md. R. 775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B, E amended effective April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01F adopted effective April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 20, 2016 (43:12 Md. R. 666); June 19, 2017 (44:12 Md. R. 588); August 13, 2018 (45:16 Md. R. 775); April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 20, 2016 (43:12 Md. R. 666); June 19, 2017 (44:12 Md. R. 588); April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, G amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective August 13, 2018 (45:16 Md. R. 775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 13, 2018 (45:16 Md. R. 775); April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, F amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 19, 2017 (44:12 Md. R. 588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective June 20, 2016 (43:12 Md. R. 666); April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09G adopted effective June 19, 2017 (44:12 Md. R. 588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, B amended effective August 13, 2018 (45:16 Md. R. 775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective June 20, 2016 (43:12 Md. R. 666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective August 13, 2018 (45:16 Md. R. 775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective June 19, 2017 (44:12 Md. R. 588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective August 13, 2018 (45:16 Md. R. 775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective April 14, 2025 (52:7 Md. R. 322)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective April 14, 2025 (52:7 Md. R. 322)</annotation> </annotations> </chapter> <chapter num="19" heading="State Recognition of an Electronic Advance Directives Service"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the State Recognition of an electronic advance directives service. Only an electronic advance directives service that is awarded State Recognition status by the Maryland Health Care Commission pursuant to this chapter may represent itself as a State-Recognized electronic advance directives service that is authorized to connect to the State-Designated Health Information Exchange.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advance Care Planning” means a process through which an individual considers and documents in a formal manner the individual’s preferences for the receipt of health care, including through the use of an advance directive.</text> </paragraph> <paragraph num="(2)"> <text>“Advance directive” has the meaning stated in Health-General Article, Title 5 Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Commission” means the Maryland Health Care Commission.</text> </paragraph> <paragraph num="(4)"> <text>“Declarant” means a competent individual who makes an advance directive while capable of making and communicating an informed decision.</text> </paragraph> <paragraph num="(5)"> <text>“Electronic advance directives service” or “service” means a corporation, firm, association, or other entity that offers electronic advance directives services by way of a web-based application using cloud-based technology.</text> </paragraph> <paragraph num="(6)"> <text>“Executive Director” means the Executive Director of the Commission.</text> </paragraph> <paragraph num="(7)"> <text>“Health care agent” means an individual appointed by a declarant under an advance directive to make health care decisions on behalf of a declarant.</text> </paragraph> <paragraph num="(8)"> <text>“State-Designated HIE” means an entity designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“State Recognition” or “State-Recognized” means the status awarded by the Commission to an approved electronic advance directives service that has met State Recognition criteria.</text> </paragraph> <paragraph num="(10)"> <text>“State Recognition criteria” or “criteria” means technology, security, privacy, and other standards established by the Commission in accordance with Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Vendor” means an electronic advance directive service..</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Criteria for State Recognition of an Electronic Advance Directives Service."> <paragraph num="A."> <text>The Commission will assess the application of an electronic advance directives service for State Recognition in accordance with criteria approved by the Commission in accordance with the process set forth in this Regulation.</text> </paragraph> <paragraph num="B."> <text>Commission staff shall publish in the Maryland Register and on the Commission’s website a notice and draft criteria by which the Commission may consider an application of an electronic advance directives service for State Recognition.</text> <paragraph num="(1)"> <text>The notice shall specify the date by which public comments are due.</text> </paragraph> <paragraph num="(2)"> <text>Commission staff shall analyze public comments received and recommend criteria for use by the Commission in determining whether the Commission will award State Recognition to an electronic advance directives service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission will consider the public comments and Commission staff’s recommendation in establishing the applicable criteria.</text> </paragraph> <paragraph num="D."> <text>The criteria approved by the Commission shall be published in the Maryland Register and in a dated posting on the Commission’s website.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedure for Initial State Recognition."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>An electronic advance directives service seeking State Recognition shall submit an application in the form and manner specified by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The application, and all information supplementing the application, shall be signed by at least one person authorized by the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of this application (or the supplementary information) are true to the best of my knowledge, information, and belief.”</text> </paragraph> </paragraph> <paragraph num="B."> <text>An electronic advance directives service seeking State Recognition shall:</text> <paragraph num="(1)"> <text>Demonstrate that it meets all State Recognition criteria in effect at the date of the Commission's receipt of the initial application;</text> </paragraph> <paragraph num="(2)"> <text>Affirm under penalties of perjury that, within the last 10 years, no current or former owner or senior manager of the service or a current or former owner or senior manager of any related or affiliated service has:</text> <paragraph num="(a)"> <text>Been convicted of a felony or pleaded guilty, nolo contendere, entered a best interest plea of guilty, or received a diversionary disposition regarding a felony;</text> </paragraph> <paragraph num="(b)"> <text>Received a determination of exclusion from participation in Medicare or State health care programs under 42 U.S.C. §1320a-7 in any case with respect to a criminal or civil charge of Medicare or Medicaid fraud or abuse; or</text> </paragraph> <paragraph num="(c)"> <text>Been found in violation of State or federal laws or regulations that govern the operation of, or relate in any way to, an electronic advance directives service;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Affirm under penalties of perjury that the service or any related or affiliated service:</text> <paragraph num="(a)"> <text>Has no pending complaints, judgments, liens, or any final judgment or liens; or</text> </paragraph> <paragraph num="(b)"> <text>Has not been the subject of an investigation by or order of any local, State, or federal governmental agency;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide all required documentation;</text> </paragraph> <paragraph num="(5)"> <text>Timely provide additional information requested by Commission staff as needed to complete analysis of the application and make a recommendation to the Commission;</text> </paragraph> <paragraph num="(6)"> <text>Send written notice to the Commission of any change in information submitted in the initial application within ten business days after the change is effective; and</text> </paragraph> <paragraph num="(7)"> <text>Agree to comply with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Review of Applications.</text> <paragraph num="(1)"> <text>Commission staff shall:</text> <paragraph num="(a)"> <text>Review an application to determine its compliance with State Recognition criteria; and</text> </paragraph> <paragraph num="(b)"> <text>Prepare a recommendation to the Commission on the application, detailing the reasons for the recommendation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If Commission staff recommends denial of an application for State Recognition:</text> <paragraph num="(a)"> <text>An applicant has ten days after electronic delivery of the Commission staff's recommended denial in which to make a written filing taking exceptions to the staff's recommendation; and</text> </paragraph> <paragraph num="(b)"> <text>Each applicant that timely submits a written filing may present oral argument on its written exceptions to the Commission, not to exceed 10 minutes per applicant unless time is extended by the Chair of the Commission.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission may award State Recognition to each electronic advance directives service that meets all State Recognition criteria unless the Commission:</text> <paragraph num="(a)"> <text>Determines that it is in the public interest to award State Recognition to fewer than all the electronic advance directives services that meet the qualifications for State Recognition; and</text> </paragraph> <paragraph num="(b)"> <text>Details the bases for its decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Duration of State Recognition.</text> <paragraph num="(1)"> <text>State Recognition is valid for three years from its issuance, unless suspended or revoked by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>An electronic advance directives service to which the Commission grants State Recognition shall acknowledge the status in writing and agree to comply with the terms and conditions of the award of State Recognition status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedure for Renewal of State Recognition."> <paragraph num="A."> <text>An electronic advance directives service seeking renewal of its State Recognition status shall:</text> <paragraph num="(1)"> <text>At least 45 days prior to the expiration of State Recognition status, file a complete application for renewal in a form and manner specified by the Commission; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate compliance with the State Recognition criteria in effect at the date of the Commission’s receipt of the application for renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Commission staff shall review a renewal application and make a recommendation to the Commission regarding:</text> <paragraph num="(1)"> <text>The applicant’s compliance with the State Recognition criteria;</text> </paragraph> <paragraph num="(2)"> <text>The applicant’s compliance with terms and conditions of the prior recognition; and</text> </paragraph> <paragraph num="(3)"> <text>Its assessment of the quality of the service provided by the electronic advance directives service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission shall approve an application for renewal of State Recognition status by an electronic advance directives service that:</text> <paragraph num="(1)"> <text>Continues to meet all State Recognition criteria;</text> </paragraph> <paragraph num="(2)"> <text>Has complied with the terms and condition of its previous award of State Recognition status; and</text> </paragraph> <paragraph num="(3)"> <text>Has provided high quality service to persons who utilize its electronic advance directives service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If Commission staff recommends denial of a renewal application, the procedure in Regulation .04C(2) of this chapter applies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nontransferability of State Recognition."> <text>State Recognition issued pursuant to this chapter may not be sold, assigned, leased, or transferred in any way, except as provided in Regulation .07 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Closure, Sale, Merger, Lease, Assignment, or Transfer of All or Part of a State-Recognized Electronic Advance Directives Service."> <paragraph num="A."> <text>At least 90 days before a State-Recognized electronic advance directives service closes on a sale, merger, lease, assignment, or transfer of all or part of a State-Recognized electronic advance directives service, the State-Recognized electronic advance directives service shall:</text> <paragraph num="(1)"> <text>Submit in writing to the Commission information requested by Commission staff about the desired change and a plan that assures the proposed transaction:</text> <paragraph num="(a)"> <text>Results in the secure transfer to another State-Recognized electronic advance directives service;</text> </paragraph> <paragraph num="(b)"> <text>Provides notice of the proposed transaction to the Commission, to the Maryland Department of Health, to the State-Designated Health Information Exchange, and to the Consumer Protection Division of the Office of the Maryland Attorney General; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice of the proposed transaction electronically and on the Vendor’s website to each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive, which at a minimum, includes:</text> <paragraph num="(i)"> <text>Information about the transfer of the declarant’s advanced directive to another State-Recognized entity;</text> </paragraph> <paragraph num="(ii)"> <text>The name, contact information and web address of the State-Recognized receiving entity;</text> </paragraph> <paragraph num="(iii)"> <text>The date the transfer will occur; and</text> </paragraph> <paragraph num="(iv)"> <text>Specific instructions about how the transfer of an advance directive impacts the declarant and the health care agent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Not proceed with the proposed transaction until it receives written determination from the Executive Director that State Recognition status may be transferred as a result of the proposed sale, merger, lease, assignment, or transfer of all or part of a State-Recognized electronic advance directives service.</text> </paragraph> <paragraph num="(3)"> <text>The provisions of §A(1) of this regulation do not apply to a State-Recognized electronic advance directives service that seeks to sell, merge, lease, assign, or transfer all or part of a State-Recognized electronic advance directives service to:</text> <paragraph num="(a)"> <text>A person who was identified as a majority owner of the electronic advance directives service at the time of the most recent State Recognition by the Commission; or</text> </paragraph> <paragraph num="(b)"> <text>To an entity identified as the majority owner of the electronic advance directives service at the time of the most recent State Recognition by the Commission and whose membership or ownership, and percentage of ownership remain substantially the same as identified at the time of the most recent State Recognition by the Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>As soon as a State-Recognized electronic advance directives service has information that sets forth a reasonable basis to believe that its ability to continue to operate as a State-Recognized electronic advance directives service will be materially affected, and no fewer than 90 days prior to an anticipated closure, it shall submit complete written information to the Commission, along with a plan that includes provisions assuring the following:</text> <paragraph num="(1)"> <text>The secure transfer of electronic advance directives to another State-Recognized electronic advance directives service to the extent that such transfer is consistent with State and federal law;</text> </paragraph> <paragraph num="(2)"> <text>Submission of any reporting required under an existing State or federal grant;</text> </paragraph> <paragraph num="(3)"> <text>Plans for the continuation of electronic advance directives services during a period of transition and for a mutually agreed timeframe prior to the transfer of electronic advance directives to another State-Recognized electronic advance directives service or until the Commission awards State Recognition to a new electronic advance directives service to whom the existing service shall transfer existing advance directives;</text> </paragraph> <paragraph num="(4)"> <text>Plans for such transition services to a successor State-Recognized electronic advance directives service as are reasonably feasible given the circumstances of the closure; and</text> </paragraph> <paragraph num="(5)"> <text>A minimum of 45 days advance notice of the full or partial closure to each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive in accordance with §A(1)(c) of this regulation, to the Commission, to the Maryland Department of Health, to the State-Designated Health Information Exchange, and the Consumer Protection Division of the Office of the Maryland Attorney General.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Commission Oversight of State-Recognized Electronic Advance Directives Services."> <paragraph num="A."> <text>Commission staff may, on its own initiative or in response to information provided to the Commission, investigate any State-Recognized electronic advance directives service.</text> </paragraph> <paragraph num="B."> <text>Failure of a State-Recognized electronic advance directives service to provide full information requested by Commission staff in a timely and complete manner is grounds for suspension or revocation of State Recognition status.</text> </paragraph> <paragraph num="C."> <text>Following Commission staff’s investigation, the Executive Director may issue a notice of proposed action, which may include the following:</text> <paragraph num="(1)"> <text>A time-limited opportunity to correct deficiencies identified by the investigation;</text> </paragraph> <paragraph num="(2)"> <text>Suspension of the State Recognition of an electronic advance directives service for a definite period of time after which, depending upon the circumstances of the case and completion of appropriate corrective actions, the Vendor may seek reinstatement of its State Recognition; or</text> </paragraph> <paragraph num="(3)"> <text>Revocation of State Recognition.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An electronic advance directives service that receives a notice of proposed action from the Executive Director may request an opportunity to show cause why the proposed action should not be implemented. A written request to show cause shall be filed with the Commission within 20 days of the issuance of the notice of proposed action and shall:</text> <paragraph num="(1)"> <text>State with particularity the grounds and factual basis for the electronic advance directives service's disagreement with the proposed action;</text> </paragraph> <paragraph num="(2)"> <text>Include each fact upon which the electronic advance directives service relies to show cause why the proposed action should not be taken; and</text> </paragraph> <paragraph num="(3)"> <text>Be supported by relevant documentation and affidavits.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Commission shall determine whether to impose the proposed action or a different action under the exceptions procedure provided in Regulation .04C(2) of this chapter.</text> </paragraph> <paragraph num="F."> <text>In the event that State Recognition status is not renewed, or the Commission suspends or revokes State Recognition status, the electronic advance directives service must notify each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive about the impact of the action on accessibility of the advance directive.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-302.2, 5-602, 5-622, 19-103(c)(2)(i) and (ii), and 19-144, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 12, 2018 (45:5 Md. R. 285)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, d amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective January 9, 2023 (49:27 Md. R. 1110)</annotation> </annotations> </chapter> </subtitle> <subtitle num="26" heading="Board of Acupuncture"> <chapter num="01" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The fee schedule applies to all acupuncturists who apply for licensure or license renewal and auricular detoxification specialists.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Board” means the State Board of Acupuncture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Initial application — $525;</text> </paragraph> <paragraph num="B."> <text>Renewal application — December 1997 and beyond — $525;</text> </paragraph> <paragraph num="C."> <text>Application for inactive status — $100;</text> </paragraph> <paragraph num="D."> <text>Late application (any application) — $100;</text> </paragraph> <paragraph num="E."> <text>Reinstatement — $200;</text> </paragraph> <paragraph num="F."> <text>Fine for failure to notify Board of change in name or address — $50;</text> </paragraph> <paragraph num="G."> <text>Examination equivalency review plus all necessary travel, accommodations, and translation or other expenses — $250;</text> </paragraph> <paragraph num="H."> <text>Application for professional corporate name — $20;</text> </paragraph> <paragraph num="I."> <text>Application for certification to practice acupuncture on animals — $100;</text> </paragraph> <paragraph num="J."> <text>Auricular detoxification specialist registration — $50;</text> </paragraph> <paragraph num="K."> <text>Auricular detoxification specialist registration renewal — $25;</text> </paragraph> <paragraph num="L."> <text>Auricular detoxification specialist registration reinstatement — $100;</text> </paragraph> <paragraph num="M."> <text>License verification — $50; and</text> </paragraph> <paragraph num="N."> <text>Roster — $25.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Corporations and Associations Article, §§5-101 — 5-131;Health Occupations Article, §§1A-205, 1A-206, and 1A-302; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision under COMAR 10.26.02 effective December 23, 1994 (22:2 Md. R. 72); emergency status expired June 23, 1995</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 20, 2009 (36:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 1, 2001 (28:19 Md. R. 1685); April 20, 2009 (36:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 17, 1996 (23:12 Md. R. 871)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective December 5, 1997 (24:26 Md. R. 1752); amended permanently effective May 4, 1998 (25:9 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 1, 2001 (28:19 Md. R. 1685)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); emergency status expired June 4, 2002</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective June 1, 2002 (29:12 Md. R. 924); amended permanently effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 20, 2009 (36:8 Md. R. 596); October 17, 2011 (38:21 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, M amended effective August 5, 2013 (40:15 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective December 21, 2015 (42:25 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03M, N adopted effective April 11, 2005 (32:7 Md. R. 681)</annotation> </annotations> </chapter> <chapter num="02" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of acupuncture.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to:</text> <paragraph num="(1)"> <text>An individual employed by the federal government as an acupuncturist while practicing within the scope of that employment;</text> </paragraph> <paragraph num="(2)"> <text>A student, trainee, or visiting teacher designated as such while participating in a course of study or training under the supervision of a licensed acupuncturist in a program approved by the Board or the Maryland Higher Education Commission; or</text> </paragraph> <paragraph num="(3)"> <text>An individual practicing a health occupation who is authorized to practice under a provision of the Annotated Code of Maryland, including:</text> <paragraph num="(a)"> <text>A physician authorized under Health Occupations Article, Title 14, Annotated Code of Maryland, to perform acupuncture as it is defined in that title,</text> </paragraph> <paragraph num="(b)"> <text>A dentist authorized under Health Occupations Article, Title 4, Annotated Code of Maryland, to perform acupuncture in connection with the practice of dentistry, or</text> </paragraph> <paragraph num="(c)"> <text>A veterinarian licensed under the Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, who performs acupuncture on animals in connection with the practice of veterinary medicine.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ABAA” means the American Board of Animal Acupuncture.</text> </paragraph> <paragraph num="(2)"> <text>“ACAHM” means the Accreditation Commission for Acupuncture and Herbal Medicine.</text> </paragraph> <paragraph num="(3)"> <text>“Acupoint injection therapy” means a form of acupuncture that stimulates acupuncture points by subcutaneous, intramuscular, and intradermal injection with approved sterile substances, specifically manufactured for non-intravenous injection.</text> </paragraph> <paragraph num="(4)"> <text>“Acupuncture” means a form of health care based on East Asian medical theories of energetic physiology that describe the interrelationship of the body organs and functions of a human or animal.</text> </paragraph> <paragraph num="(5)"> <text>“Applicant” means an individual who has applied to the Board for a license to practice acupuncture in this State.</text> </paragraph> <paragraph num="(6)"> <text>“Auricular detoxification” means an acupuncture technique that involves needling the external auricle of the human ear to assist individuals undergoing detoxification from addictive substances and restore health.</text> </paragraph> <paragraph num="(7)"> <text>“Board” means the State Board of Acupuncture.</text> </paragraph> <paragraph num="(8)"> <text>“CCAHM” means the Council of Colleges of Acupuncture and Herbal Medicine.</text> </paragraph> <paragraph num="(9)"> <text>“License” means a license issued by the Board to practice acupuncture in this State.</text> </paragraph> <paragraph num="(10)"> <text>“NADA” means the National Acupuncture Detoxification Association.</text> </paragraph> <paragraph num="(11)"> <text>“NCCAOM” means the National Commission for the Certification of Acupuncture and Oriental Medicine.</text> </paragraph> <paragraph num="(12)"> <text>“Practice acupuncture” means the use of East Asian medical therapies for the purpose of normalizing energetic physiological functions including pain control, and for the promotion, maintenance, and restoration of health including, but not limited to:</text> <paragraph num="(a)"> <text>Stimulation of a human or animal body by the insertion of needles;</text> </paragraph> <paragraph num="(b)"> <text>The application of moxibustion; and</text> </paragraph> <paragraph num="(c)"> <text>Manual, mechanical, thermal, or electrical therapies only when performed in accordance with the principles of] East Asian medical theories.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Pro bono work” means work provided within the scope of practice of the licensee:</text> <paragraph num="(a)"> <text>Without financial reimbursement; or</text> </paragraph> <paragraph num="(b)"> <text>Without direct financial gain.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“TOEFL” means the Test of English as a Foreign Language.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for License."> <paragraph num="A."> <text>To qualify for a license, an applicant shall:</text> <paragraph num="(1)"> <text>Submit a completed application in the format provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Provide at the applicant's expense, in English, all documentation required by §§B and C of this regulation or copies of original documents with English translations;</text> </paragraph> <paragraph num="(3)"> <text>Pay the necessary fees established in COMAR 10.26.01.03;</text> </paragraph> <paragraph num="(4)"> <text>Submit a current copy of a:</text> <paragraph num="(a)"> <text>Government-issued photographic identification; or</text> </paragraph> <paragraph num="(b)"> <text>Passport-size photograph; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Meet with the Board to review the application if requested by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To prove that the applicant is 18 years old or older, the applicant shall provide a certified copy of an official government or institutional record, if requested by the Board.</text> </paragraph> <paragraph num="C."> <text>The applicant shall provide documentary evidence of having met one of the following standards for education, training, or demonstrated experience:</text> <paragraph num="(1)"> <text>Graduation with a master’s degree from an accredited educational institution with a practice relevant course of training that is equivalent to or exceeds at least 1,800 hours in acupuncture, including 300 clinical hours, that is:</text> <paragraph num="(a)"> <text>Approved by the Maryland Higher Education Commission;</text> </paragraph> <paragraph num="(b)"> <text>Accredited by the ACAHM; or</text> </paragraph> <paragraph num="(c)"> <text>Found by the Board to be equivalent to a course approved or accredited by the authority listed under §C(1)(a) or (b) of this regulation; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Achievement of a:</text> <paragraph num="(a)"> <text>Diplomate in Acupuncture from the NCCAOM; or</text> </paragraph> <paragraph num="(b)"> <text>Passing score on an examination that is determined by the Board to be equivalent to the examination given by the NCCAOM.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant shall demonstrate proof of proficiency in the written and oral communication of the English language by providing documentary evidence that the applicant has:</text> <paragraph num="(1)"> <text>Completed at least 30 classroom credits from:</text> <paragraph num="(a)"> <text>An English-speaking undergraduate school;</text> </paragraph> <paragraph num="(b)"> <text>An English-speaking professional school;</text> </paragraph> <paragraph num="(c)"> <text>A community college; or</text> </paragraph> <paragraph num="(d)"> <text>An undergraduate or graduate program at a college or university;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Achieved a passing score on the TOEFL within the 2 years preceding license application; or</text> </paragraph> <paragraph num="(3)"> <text>Provided proof of passing scores on the NCCAOM written and practical examination components in English.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Approval of Applicant for Licensure."> <paragraph num="A."> <text>The Board shall determine whether an application is complete as received, with all required documentation enclosed.</text> </paragraph> <paragraph num="B."> <text>Within 90 days of its receipt of a completed application and required information or documentation, the Board shall approve or deny the application.</text> </paragraph> <paragraph num="C."> <text>The Board may close an incomplete application when the information needed to complete the application is not received within 120 days of the submission date.</text> </paragraph> <paragraph num="D."> <text>Upon approval of an application, the Board shall issue a document authorizing the applicant to practice acupuncture in this State in accordance with Health Occupations Article, §1A-304, Annotated Code of Maryland, and the regulations in this chapter.</text> </paragraph> <paragraph num="E."> <text>Except with approval of the Board, an applicant may not withdraw an application while under investigation or after having received a notice of denial of licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Term, Renewal, Reinstatement, and Inactive Status."> <paragraph num="A."> <text>Unless renewed, the term of a license is valid through the expiration date.</text> </paragraph> <paragraph num="B."> <text>Renewal.</text> <paragraph num="(1)"> <text>At least 1 month before a license expires, the Board shall send to the licensee a renewal notice that states the:</text> <paragraph num="(a)"> <text>Date on which the current license expires;</text> </paragraph> <paragraph num="(b)"> <text>Date by which the renewal application is to be received by the Board for the renewal to be issued and mailed before the license expires; and</text> </paragraph> <paragraph num="(c)"> <text>Amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before a license expires, the licensee may renew if the licensee:</text> <paragraph num="(a)"> <text>Submits to the Board a completed renewal application in the format required by the Board along with documentation that the licensee meets the requirements for a license;</text> </paragraph> <paragraph num="(b)"> <text>Pays the renewal fee specified in COMAR 10.26.01.03; and</text> </paragraph> <paragraph num="(c)"> <text>If requested, submits to the Board documentation that the licensee has complied with the continuing education requirements established under COMAR 10.26.06.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee shall keep the Board apprised of the licensee's current address and telephone number or shall pay a fee as specified in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee has a grace period of 30 days after the licensee's license expires to renew retroactively if the licensee:</text> <paragraph num="(1)"> <text>Otherwise is entitled to have the license renewed; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the renewal fee and late fee set by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the applicant’s license expires, an applicant may not practice acupuncture in the State until the renewal application is approved by the Board.</text> </paragraph> <paragraph num="E."> <text>Reinstatement. Thirty-one days after the expiration date of a license, a licensee whose license has expired without seeking inactive status may have the license reinstated upon meeting all of the following:</text> <paragraph num="(1)"> <text>Submission of a completed reinstatement application in the format required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Payment of the reinstatement fee, and renewal fee, specified in COMAR 10.26.01.03; and</text> </paragraph> <paragraph num="(3)"> <text>One of the following:</text> <paragraph num="(a)"> <text>Thirty hours of continuing education within the 2 years that are most recent to the requested reinstatement date; or</text> </paragraph> <paragraph num="(b)"> <text>Passage of the acupuncture exam given by the NCCAOM within 4 years from the date of reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>The Board shall place a licensee on inactive status for a maximum period of 6 years if the licensee submits to the Board within 30 days after the expiration of a license:</text> <paragraph num="(a)"> <text>An application for inactive status in the format required by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>The inactive status application fee specified in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To reactivate a license from inactive status, the applicant shall:</text> <paragraph num="(a)"> <text>Satisfy the renewal requirements in §B(2)(a) and (b) of this regulation that exist at the time the individual changes from inactive to active status; and</text> </paragraph> <paragraph num="(b)"> <text>Complete 30 hours of continuing education as specified under COMAR 10.26.06.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The licensee shall renew inactive status every 2 years, but not to exceed 6 years, in the format required by the Board and pay the fee as set forth in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>A licensee applying for renewal shall complete 30 hours of relevant continuing education during the 2-year period preceding the expiration of the license which include the following:</text> <paragraph num="(a)"> <text>At least 20 hours in formally organized programs which are relevant to the practice of acupuncture and Oriental medicine and are approved by the Board or sponsored by, but not limited to, the following organizations and their member organizations:</text> <paragraph num="(i)"> <text>American Academy of Medical Acupuncture;</text> </paragraph> <paragraph num="(ii)"> <text>American Association of Acupuncture and Oriental Medicine (AAAOM);</text> </paragraph> <paragraph num="(iii)"> <text>Council of Colleges of Acupuncture and Oriental Medicine (CCAOM);</text> </paragraph> <paragraph num="(iv)"> <text>Colleges and universities accredited by the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM);</text> </paragraph> <paragraph num="(v)"> <text>National Commission for the Certification of Acupuncture and Oriental Medicine (NCCAOM);</text> </paragraph> <paragraph num="(vi)"> <text>Society for Acupuncture Research; or</text> </paragraph> <paragraph num="(vii)"> <text>The National Acupuncture Detoxification Association;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Not more than 10 hours of formally organized training programs in Western science and medical practices, medical ethics, medical research, or cardiopulmonary resuscitation which are relevant to the practice of acupuncture and are sponsored by, but not limited to, organizations listed in §F(1)(a) of this regulation and the following organizations:</text> <paragraph num="(i)"> <text>World Health Organization (WHO);</text> </paragraph> <paragraph num="(ii)"> <text>National Institutes of Health (NIH);</text> </paragraph> <paragraph num="(iii)"> <text>American Medical Association (AMA);</text> </paragraph> <paragraph num="(iv)"> <text>American Nurses Association (ANA);</text> </paragraph> <paragraph num="(v)"> <text>American Psychiatric Association (APA);</text> </paragraph> <paragraph num="(vi)"> <text>Red Cross;</text> </paragraph> <paragraph num="(vii)"> <text>Local colleges; or</text> </paragraph> <paragraph num="(viii)"> <text>Local hospitals;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Not more than 10 hours of training in approved programs which will assist a licensee to carry out the licensee's professional responsibilities, including, but not limited to:</text> <paragraph num="(i)"> <text>Management courses for a school administrator;</text> </paragraph> <paragraph num="(ii)"> <text>Foreign language training for translators of relevant texts;</text> </paragraph> <paragraph num="(iii)"> <text>Educational methodology for teachers of acupuncture;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Not more than 10 hours teaching acupuncture and related Oriental medical therapies in an accredited school or in a program approved for acupuncture continuing education;</text> </paragraph> <paragraph num="(e)"> <text>Not more than 7 hours of pro bono work as outlined in §F(3) of this regulation; or</text> </paragraph> <paragraph num="(f)"> <text>Not more than 7 hours in published writing or articles in acupuncture and Oriental medicine that are:</text> <paragraph num="(i)"> <text>Peer-reviewed research or peer-reviewed clinically relevant articles in acupuncture and Oriental medicine; and</text> </paragraph> <paragraph num="(ii)"> <text>Limited to 4 hours per article.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pro Bono Work.</text> <paragraph num="(a)"> <text>Pro bono work shall earn 1 credit hour for each 3 hours of pro bono activity up to a maximum of 7 credit hours per renewal cycle.</text> </paragraph> <paragraph num="(b)"> <text>Pro bono work shall be for the provision of acupuncture services provided through an organization offering humanitarian services such as, but not limited to:</text> <paragraph num="(i)"> <text>Domestic or international victims in an emergency situation or disaster area;</text> </paragraph> <paragraph num="(ii)"> <text>Low income or underserved areas or populations;</text> </paragraph> <paragraph num="(iii)"> <text>Special needs populations; or</text> </paragraph> <paragraph num="(iv)"> <text>United States military personnel.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Upon completion of the pro bono work, the licensee shall obtain from the facility written documentation of completion of pro bono hours including:</text> <paragraph num="(i)"> <text>The name of the facility;</text> </paragraph> <paragraph num="(ii)"> <text>The address where the pro bono work was provided;</text> </paragraph> <paragraph num="(iii)"> <text>The type of work that was done;</text> </paragraph> <paragraph num="(iv)"> <text>The number of hours of actual work provided for which the licensee desires credit hours; and</text> </paragraph> <paragraph num="(v)"> <text>A statement guaranteeing that the work provided no financial benefit to licensee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees shall maintain the documentation of their continuing education credits for 4 years from the date of their acupuncture renewal.</text> </paragraph> <paragraph num="(4)"> <text>If requested by the Board, a licensee shall provide proof of continuing education attendance by providing documentation of:</text> <paragraph num="(a)"> <text>Name of the program;</text> </paragraph> <paragraph num="(b)"> <text>Date of the program;</text> </paragraph> <paragraph num="(c)"> <text>Number of continuing education hours earned; and</text> </paragraph> <paragraph num="(d)"> <text>Name of the sponsoring organization.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Change of Mailing Address, Legal Name, or Email Address.</text> <paragraph num="(1)"> <text>A licensee shall give the Board written notice within 30 days of a change of:</text> <paragraph num="(a)"> <text>Mailing address;</text> </paragraph> <paragraph num="(b)"> <text>Legal name; or</text> </paragraph> <paragraph num="(c)"> <text>Email address if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fee as set forth under COMAR 10.26.01.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Acupuncture on Animals."> <paragraph num="A."> <text>To obtain certification from the Board as qualified to practice acupuncture on animals, an applicant shall:</text> <paragraph num="(1)"> <text>Possess a current active license to practice acupuncture in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a Board-approved specialty training program in animal acupuncture from a school accredited by ABAA, ACAHM, or approved by the Maryland Higher Education Commission that consists of a minimum of 135 hours of theory and clinical training and includes at a minimum in each of the following:</text> <paragraph num="(a)"> <text>90 hours in diagnosis of energy dynamics and treatment of animals,</text> </paragraph> <paragraph num="(b)"> <text>15 hours in comparative functional anatomy and physiology of animals,</text> </paragraph> <paragraph num="(c)"> <text>15 hours in animal handling, restraints, and emergencies, and</text> </paragraph> <paragraph num="(d)"> <text>20 hours in introduction to animal diseases and zoonotics that require the immediate attention of a veterinary practitioner;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Complete and submit the application provided by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Pay the fee as specified in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To practice acupuncture on animals, the licensed acupuncturist:</text> <paragraph num="(1)"> <text>Shall possess certification for animal acupuncture from the Board;</text> </paragraph> <paragraph num="(2)"> <text>Shall cooperate and consult with a veterinarian licensed in the State by:</text> <paragraph num="(a)"> <text>Beginning acupuncture treatment on an animal only if the animal has been seen by a veterinary practitioner within the previous 14 days,</text> </paragraph> <paragraph num="(b)"> <text>Adhering to the terms and conditions of treatment decided by the veterinary practitioner, including the degree of communication and collaboration between the veterinary practitioner and the individual practicing acupuncture, and</text> </paragraph> <paragraph num="(c)"> <text>Reporting to the veterinary practitioner at the end of the animal's acupuncture treatment or at monthly intervals at the discretion of the veterinary practitioner; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>May not practice acupuncture on an animal for which the licensed acupuncturist has not been appropriately trained in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certification Renewal, Reinstatement, and Reactivation.</text> <paragraph num="(1)"> <text>The licensee may, as a part of the 30 continuing education unit renewal requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture.</text> </paragraph> <paragraph num="(2)"> <text>The licensee may, as a part of the 30 continuing education unit reinstatement requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture.</text> </paragraph> <paragraph num="(3)"> <text>The licensee may, as a part of the 30 continuing education unit reactivation requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall maintain a registry of all:</text> <paragraph num="(1)"> <text>Licensed acupuncturists certified by the Board as qualified to practice acupuncture on animals; and</text> </paragraph> <paragraph num="(2)"> <text>Animal acupuncture training programs that the Board approves.</text> </paragraph> </paragraph> <paragraph num="E."> <text>On or after the effective date of this regulation, unless the person is certified by the Board as qualified to practice acupuncture on animals, an individual may not:</text> <paragraph num="(1)"> <text>Represent to the public that the individual is an animal acupuncturist; and</text> </paragraph> <paragraph num="(2)"> <text>Practice acupuncture on animals.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Exception to Certification. This regulation does not apply to an individual who practices acupuncture on an animal under a research protocol which has been approved by an Animal Use and Care Committee as provided in 9 CFR Ch. 1, Part 2, Subpart C, §§2.30—2.38.</text> </paragraph> <paragraph num="G."> <text>Violation of this regulation constitutes unprofessional conduct and may result in disciplinary action as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Auricular Detoxification Specialist."> <paragraph num="A."> <text>Qualification. To qualify as an auricular detoxification specialist, an applicant shall be a certified or licensed practitioner in the State as one of the following health care professionals who works directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients:</text> <paragraph num="(1)"> <text>A certified professional counselor—alcohol and drug;</text> </paragraph> <paragraph num="(2)"> <text>A certified associate counselor—alcohol and drug;</text> </paragraph> <paragraph num="(3)"> <text>A supervised counselor—alcohol and drug;</text> </paragraph> <paragraph num="(4)"> <text>A licensed clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(5)"> <text>A licensed nurse;</text> </paragraph> <paragraph num="(6)"> <text>A licensed psychologist who works directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients; or</text> </paragraph> <paragraph num="(7)"> <text>A licensed certified social worker—clinical who works directly with the chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A practitioner that is a medical doctor shall obtain a medical acupuncture certification specific to physicians in accordance with COMAR 10.32.15.</text> </paragraph> <paragraph num="C."> <text>Registration. The Board shall maintain a registry of all certified auricular detoxification specialists. To apply for certification with the Board as an auricular detoxification specialist, an applicant shall:</text> <paragraph num="(1)"> <text>Provide documentation of successful completion of a Board and NADA approved training program that consists of a minimum 70-hour basic training of which 40 hours are clinical training which includes the following training and subject matter:</text> <paragraph num="(a)"> <text>At least 5 treatments during a 10-minute period with good point location and techniques;</text> </paragraph> <paragraph num="(b)"> <text>The uses and limitations of the treatment;</text> </paragraph> <paragraph num="(c)"> <text>Communal treatment effect and maintaining an appropriate atmosphere;</text> </paragraph> <paragraph num="(d)"> <text>Clean needle technique;</text> </paragraph> <paragraph num="(e)"> <text>The limited scope of practice of auricular detoxification and other ethical principles;</text> </paragraph> <paragraph num="(f)"> <text>The implications of the role of auricular acupuncture for addition in the larger addition treatment context;</text> </paragraph> <paragraph num="(g)"> <text>Preparation of written chart notes regarding status, treatment given, and patient response;</text> </paragraph> <paragraph num="(h)"> <text>Adjunctive nature of auricular acupuncture for addiction and the importance of collaboration and communication with the treatment team;</text> </paragraph> <paragraph num="(i)"> <text>The psycho-spiritual nature of recovery and the ability to respect and support the client's individual beliefs and cognitive process;</text> </paragraph> <paragraph num="(j)"> <text>Methods to modify treatment appropriately and to respond to adverse clinical situations should they occur;</text> </paragraph> <paragraph num="(k)"> <text>Sensitivity, compassion, and respect for clients; and</text> </paragraph> <paragraph num="(l)"> <text>Understanding of addictions from the perspective of basic concepts of East Asian medicine;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complete an application provided by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Provide the name and address of the acupuncturist licensed by the State who shall supervise the applicant;</text> </paragraph> <paragraph num="(4)"> <text>Provide verification of active licensure in good standing in the State from the appropriate Health Occupations Board;</text> </paragraph> <paragraph num="(5)"> <text>Provide verification that an applicant works in a State-approved professional setting that specializes in the treatment of addiction; and</text> </paragraph> <paragraph num="(6)"> <text>Pay the registration fee in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Certification Renewal.</text> <paragraph num="(1)"> <text>A certified practitioner shall renew their certification every 2 years.</text> </paragraph> <paragraph num="(2)"> <text>As part of the renewal, the practitioner shall provide proof to the Board of:</text> <paragraph num="(a)"> <text>Licensure in the approved health profession;</text> </paragraph> <paragraph num="(b)"> <text>Employment working directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients;</text> </paragraph> <paragraph num="(c)"> <text>Employment working in a State-approved setting, working with chemically dependent patients of a chemical dependency program in the counseling or treatment of those patients; and</text> </paragraph> <paragraph num="(d)"> <text>Completion of three continuing education units relevant to the practice of auricular detoxification and the counseling or treatment of chemically dependent patients.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At least 1 month before a certification expires, the Board shall send a renewal notice to an auricular detoxification specialist that states:</text> <paragraph num="(a)"> <text>The date the current certification expires;</text> </paragraph> <paragraph num="(b)"> <text>The date the renewal application is to be received by the Board for the renewal to be issued before the certification expires; and</text> </paragraph> <paragraph num="(c)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Before a certification expires, a practitioner certified to perform auricular detoxification may renew the certification if the individual submits:</text> <paragraph num="(a)"> <text>A completed renewal application in the format required by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Verification from the appropriate Health Occupation Board under §A of this regulation, that confirms that the individual has a current certification or license in good standing; and</text> </paragraph> <paragraph num="(c)"> <text>The renewal fee specified in COMAR 10.26.01.03.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An individual registered to perform auricular detoxification shall maintain a current address and telephone number with the Board.</text> </paragraph> <paragraph num="(6)"> <text>A practitioner listed on the registry to perform auricular detoxification:</text> <paragraph num="(a)"> <text>May not practice using any other name than the name on their certification; and</text> </paragraph> <paragraph num="(b)"> <text>Shall immediately inform the Board of any name change.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Certification Reinstatement. An auricular detoxification specialist holding an expired certification may apply for reinstatement if the individual:</text> <paragraph num="(1)"> <text>Completes an application for reinstatement approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Submits the auricular detoxification specialist registration reinstatement fee specified in COMAR 10.26.01.03; and</text> </paragraph> <paragraph num="(3)"> <text>Submits proof of completion of at least three continuing education units directly related to the certification.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Supervision. The Board may approve a Maryland licensed acupuncturist for supervision of a practitioner on the registry to perform auricular detoxification if the licensee:</text> <paragraph num="(1)"> <text>Holds an active license in good standing to practice acupuncture in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Has completed a training program in auricular detoxification as set forth in §C of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a completed application in the format provided by the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Supervisor Responsibilities. A supervisor shall ensure that:</text> <paragraph num="(1)"> <text>Auricular detoxification specialists are sufficiently competent in the areas listed in §C(1) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The supervised auricular detoxification specialist and the Board are notified if the supervisor cannot or is unwilling to fill the role of supervisor; and</text> </paragraph> <paragraph num="(3)"> <text>An on-site visit with the auricular detoxification specialist occurs at least once annually before renewal to:</text> <paragraph num="(a)"> <text>View the setting where services are being provided; and</text> </paragraph> <paragraph num="(b)"> <text>Observe at least five treatments, within an hour, performed according to the NADA group protocol.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Setting. The clinical substance abuse program or professional setting where an individual performs auricular detoxification on patients with documented substance abuse concerns shall meet best practices within community healthcare standards.</text> </paragraph> <paragraph num="I."> <text>Complaints.</text> <paragraph num="(1)"> <text>The Board may investigate a complaint filed against an auricular detoxification specialist or the supervising licensed acupuncturist.</text> </paragraph> <paragraph num="(2)"> <text>The Board may withdraw the certification of the auricular detoxification specialist or take action against the license of the supervising acupuncturist if either individual violates an applicable law, regulation, or standard of practice while performing auricular detoxification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Acupoint Injection Therapy."> <paragraph num="A."> <text>Registration. To obtain the required registration from the Board as qualified to practice acupoint injection therapy, an applicant shall:</text> <paragraph num="(1)"> <text>Possess an active license in good standing to practice acupuncture and East Asian medicine in the State;</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete an NCCAOM, or other appropriate accreditation body endorsed specialty training program and assessment in acupoint injection therapy that consists of at least 60 hours including:</text> <paragraph num="(a)"> <text>A minimum of 40 hours of theoretical training in the required topics;</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 20 hours of live face-to-face clinical practical experience; and</text> </paragraph> <paragraph num="(c)"> <text>Instruction that meets the requirements of §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Possess a current certification by the American Heart Association or approved equivalent in basic life support;</text> </paragraph> <paragraph num="(4)"> <text>Hold a current Clean Needle Technique Certificate through CCAHM or NCCAOM;</text> </paragraph> <paragraph num="(5)"> <text>If licensed in the State for less than 2 years, possess a valid license in good standing to practice acupuncture and East Asian medicine, in any state, for at least 2 years before applying to perform acupoint injection therapy in the State; and</text> </paragraph> <paragraph num="(6)"> <text>Complete and submit an application in the format provided by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall accept the documentation from a licensee that has completed the training required to perform acupoint injection therapy prior to the effective date of this regulation if:</text> <paragraph num="(1)"> <text>The licensee provides a certificate, or other valid documentation, confirming successful completion of 60 hours of acupoint injection therapy training that complies with this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>The previously completed training does not meet the requirements of this regulation, but the licensee provides documentation of completion of supplemental training that, together with the initial training, fulfills the coursework requirements of §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Training Program Curriculum. The curriculum for the acupoint injection therapy program shall include:</text> <paragraph num="(1)"> <text>20 hours of clinical practice on a patient or patients;</text> </paragraph> <paragraph num="(2)"> <text>History and development of acupuncture injection therapy;</text> </paragraph> <paragraph num="(3)"> <text>Differential diagnosis;</text> </paragraph> <paragraph num="(4)"> <text>Definitions, concepts, and pathophysiology;</text> </paragraph> <paragraph num="(5)"> <text>The nature, function, channels entered, and contraindications of the substances stated in §F(2) of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Diseases amenable to treatment with acupuncture injection therapy and the substances appropriate to treat them;</text> </paragraph> <paragraph num="(7)"> <text>Identification of appropriate points for treatment, including palpatory diagnosis;</text> </paragraph> <paragraph num="(8)"> <text>A review of physical examination, anatomy, and referral zones;</text> </paragraph> <paragraph num="(9)"> <text>Universal precautions including management of blood borne pathogens and hazardous waste;</text> </paragraph> <paragraph num="(10)"> <text>Procedures for injections, including preparing the substances, contraindications, and precautions;</text> </paragraph> <paragraph num="(11)"> <text>Administration techniques and equipment required;</text> </paragraph> <paragraph num="(12)"> <text>Administration of the prepackaged substances authorized for acupoint injection therapy, including aseptic technique, recordkeeping and storage of substances prepared and authorized for use in acupoint injection therapy;</text> </paragraph> <paragraph num="(13)"> <text>Safety and emergency procedures; and</text> </paragraph> <paragraph num="(14)"> <text>2 hours of training in the use of intramuscular epinephrine and emergency oxygen which count toward the required theoretical and clinical training hours.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Instructors. In addition to the requirements of NCCAOM, or other appropriate accreditation body, an instructor for acupoint injection therapy shall:</text> <paragraph num="(1)"> <text>Ensure that the curriculum meets the training requirements set forth under §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Be a licensed practitioner in acupuncture in good standing in the State and be registered to practice acupoint injection therapy in the State;</text> </paragraph> <paragraph num="(3)"> <text>Possess at least 5 years of experience in the practice of acupuncture that includes acupoint injection therapy;</text> </paragraph> <paragraph num="(4)"> <text>Retain proof of compliance as set forth under this section for as long as they provide acupoint injection therapy training; and</text> </paragraph> <paragraph num="(5)"> <text>Provide proof of compliance to the Board upon request.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Training Programs. All training programs shall provide each successful student with:</text> <paragraph num="(1)"> <text>A certificate of successful completion of the program;</text> </paragraph> <paragraph num="(2)"> <text>A course syllabus outlining the schedule and curriculum of the program; and</text> </paragraph> <paragraph num="(3)"> <text>Testing requirements and the performance measure for successful completion.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Practice.</text> <paragraph num="(1)"> <text>To practice acupoint injection therapy, the licensed acupuncturist shall:</text> <paragraph num="(a)"> <text>Possess a registration for acupoint injection therapy from the Board;</text> </paragraph> <paragraph num="(b)"> <text>Explain acupoint injection therapy to the patient in advance of treatment;</text> </paragraph> <paragraph num="(c)"> <text>Obtain written informed consent specific to acupoint injection therapy that shall be included in the patient’s medical record;</text> </paragraph> <paragraph num="(d)"> <text>Only perform subcutaneous, intradermal, or intramuscular injection in accordance with the principles of acupuncture;</text> </paragraph> <paragraph num="(e)"> <text>Have an adverse event or emergency plan in place for allergic reactions to injected substances;</text> </paragraph> <paragraph num="(f)"> <text>Maintain professional liability coverage for this procedure; and</text> </paragraph> <paragraph num="(g)"> <text>Only use prepackaged and sterile acupoint injectable therapeutic substances that are:</text> <paragraph num="(i)"> <text>Acquired from an appropriately licensed entity in compliance with federal and State law; and</text> </paragraph> <paragraph num="(ii)"> <text>Stored securely and in accordance with manufacturer's specifications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the practice of acupoint injection therapy, the licensed acupuncturist, provided they have been trained on utilization of the specific therapeutic substance, may only use the following therapeutic substances for acupoint injection therapy:</text> <paragraph num="(a)"> <text>Sterile and bacteriostatic water;</text> </paragraph> <paragraph num="(b)"> <text>Saline solution;</text> </paragraph> <paragraph num="(c)"> <text>Alkalizing agents such as sodium bicarbonate;</text> </paragraph> <paragraph num="(d)"> <text>Nutritional or dietary substances;</text> </paragraph> <paragraph num="(e)"> <text>Vitamins and minerals including B-12, B-complex, C, cyanocobalamin, hydroxocobalamin, and methylcobalamin;</text> </paragraph> <paragraph num="(f)"> <text>Proteins, enzymes, and amino acids including methionine, choline, inositol, and glutathione;</text> </paragraph> <paragraph num="(g)"> <text>Sugars including dextrose and glucose;</text> </paragraph> <paragraph num="(h)"> <text>Ozone;</text> </paragraph> <paragraph num="(i)"> <text>Procaine and lidocaine;</text> </paragraph> <paragraph num="(j)"> <text>Herbal and botanical extracts including astragalus and Sarapin;</text> </paragraph> <paragraph num="(k)"> <text>Biological products including hyaluronic acid and epinephrine; and</text> </paragraph> <paragraph num="(l)"> <text>Homeopathic substances including Traumeel and Zeel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensed acupuncturist in the practice of acupoint injection therapy may not:</text> <paragraph num="(a)"> <text>Administer substances other than those specified under §F(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Administer substances that the licensed acupuncturist has not been appropriately trained in accordance with this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Give an injectable substance to a patient for self-injection; or</text> </paragraph> <paragraph num="(d)"> <text>Administer intravenous injections.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Board shall maintain a list of all:</text> <paragraph num="(1)"> <text>Licensed acupuncturists registered by the Board as qualified to practice acupoint injection therapy; and</text> </paragraph> <paragraph num="(2)"> <text>Acupoint injection therapy training programs endorsed by the NCCAOM, or other appropriate accreditation body updated at least annually.</text> </paragraph> </paragraph> <paragraph num="H."> <text>On or after the effective date of this regulation, unless the person is registered by the Board as qualified to practice acupoint injection therapy, an individual may not:</text> <paragraph num="(1)"> <text>Practice acupoint injection therapy; or</text> </paragraph> <paragraph num="(2)"> <text>Represent to the public that the individual is an acupoint injection therapy registered acupuncturist.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Violation of this regulation constitutes unprofessional conduct and may result in disciplinary action as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Name Under Which a Licensee May Practice."> <paragraph num="A."> <text>A licensee shall be licensed to practice acupuncture only under the name indicated on the license.</text> </paragraph> <paragraph num="B."> <text>A licensee wishing to change the name under which the licensee practices shall obtain prior Board approval.</text> </paragraph> <paragraph num="C."> <text>The failure of a licensee to practice under the name on the license may:</text> <paragraph num="(1)"> <text>Result in a fine; or</text> </paragraph> <paragraph num="(2)"> <text>Be considered unprofessional conduct by the Board and constitute grounds for disciplinary action.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Agriculture Article, §§2-301(g) and 2-304; Health Occupations Article, §§1-211, 1A-101, 1A-205, 1A-301, 1A-302, 1A-306, 1A-307, and 1A-316; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective February 22, 1996 (23:6 Md. R. 472); adopted permanently effective August 12, 1996 (23:16 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 1, 2001 (28:19 Md. R. 1685)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 11, 2003 (30:24 Md. R. 1741); January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective March 9, 1998 (25:5 Md. R. 369); December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, E amended effective October 1, 2001 (28:19 Md. R. 1685)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G adopted effective February 16, 2004 (31:3 Md. R. 207)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 1, 2001 (28:19 Md. R. 1685); December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective April 11, 2005 (32:7 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted as an emergency provision effective December 5, 1997 (24:26 Md. R. 1752); adopted permanently effective May 4, 1998 (25:9 Md. R. 680)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 22, 1999 (26:4 Md. R. 273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, D amended effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); emergency status expired June 4, 2002</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted as an emergency provision effective June 1, 2002 (29:12 Md. R. 924); adopted permanently effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); amended permanently effective April 11, 2005 (32:7 Md. R. 681)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective November 7, 2005 (32:22 Md. R. 1756)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 20, 2009 (36:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 28, 2009 (36:26 Md. R. 1995); October 16, 2023 (50:20 Md. R. 887); April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective January 29, 2018 (45:2 Md. R. 69); October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F repealed effective October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G repealed effective January 29, 2018 (45:2 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E repealed effective October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 20, 2012 (39:3 Md. R. 259); August 5, 2013 (40:15 Md. R. 1229); April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective December 28, 2009 (36:26 Md. R. 1995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F repealed effective October 16, 2023 (50:20 Md. R. 887)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 18, 2010 (37:21 Md. R. 1436); October 17, 2011 (38:21 Md. R. 1279); January 7, 2013 (39:26 Md. R. 1665); April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective April 13, 2026 (53:7 Md. R 328)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 effective April 13, 2026 (53:7 Md. R 328)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not apply to an individual who practices acupuncture on an animal under an animal research protocol which has been approved by an Animal Use and Care Committee as provided in 9 CFR §§2.30 — 2.38.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Board” means the State Board of Acupuncture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Practice."> <paragraph num="A."> <text>The licensee shall be concerned primarily with the welfare of the patient or client.</text> </paragraph> <paragraph num="B."> <text>A licensee who suffers from a physical, mental, or emotional impairment, including chemical abuse, which impacts the licensee's ability to practice acupuncture shall seek professional treatment and refrain from the practice of acupuncture until such time as the impairment no longer exists or reasonable accommodations can be made.</text> </paragraph> <paragraph num="C."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Use professional discretion and integrity in relationships with a member of the health care community;</text> </paragraph> <paragraph num="(2)"> <text>Be professional in conduct, with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Remain free from a conflict of interest while fulfilling the objectives and maintaining the integrity of the acupuncture profession;</text> </paragraph> <paragraph num="(4)"> <text>Provide accurate fee information to the patient, the individual responsible for payment for treatment, and the insurer;</text> </paragraph> <paragraph num="(5)"> <text>At all times respect the patient's dignity, autonomy, and privacy;</text> </paragraph> <paragraph num="(6)"> <text>Practice acupuncture only as defined in the scope of practice set forth in Health Occupations Article, §1A-205, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Cooperate with an investigation conducted by the Board, including:</text> <paragraph num="(a)"> <text>Furnishing information requested,</text> </paragraph> <paragraph num="(b)"> <text>Complying with a subpoena,</text> </paragraph> <paragraph num="(c)"> <text>Responding to a complaint at the request of the Board, and</text> </paragraph> <paragraph num="(d)"> <text>Providing meaningful and timely access to relevant patient records; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Report to the Board or other appropriate authority conduct in the practice of acupuncture that indicates a violation of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 1A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Other federal or State laws.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee may not:</text> <paragraph num="(1)"> <text>Misrepresent the licensee's credentials, qualifications, or affiliations and shall attempt to correct others who misrepresent the licensee's credentials, qualifications, or affiliations;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly engage in or condone behavior which is fraudulent, dishonest, or deceitful, or involves moral turpitude;</text> </paragraph> <paragraph num="(3)"> <text>Engage in a commercial activity which conflicts with the licensee's duties as a licensed acupuncturist;</text> </paragraph> <paragraph num="(4)"> <text>Perform acupuncture on a patient if the contraindication against acupuncture treatment exists; or</text> </paragraph> <paragraph num="(5)"> <text>Discriminate against a patient or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Relationship with Patient."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Use professional judgement in the use of evaluation and treatment procedures;</text> </paragraph> <paragraph num="(2)"> <text>Decline to administer treatment if the licensee believes that the treatment is contraindicated or unjustified;</text> </paragraph> <paragraph num="(3)"> <text>Terminate a professional relationship with patient in an appropriate manner, such as:</text> <paragraph num="(a)"> <text>Providing the patient with sufficient notice to permit the patient to obtain the services of another professional,</text> </paragraph> <paragraph num="(b)"> <text>Assisting the patient by providing referrals if appropriate, or</text> </paragraph> <paragraph num="(c)"> <text>Continuing to provide emergency treatment to the patient if treatment is required before a reasonable time has passed to allow the patient to obtain the services of another health care provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Maintain a written record of treatment of the patient under the licensee's care for at least 5 years after the termination of treatment;</text> </paragraph> <paragraph num="(5)"> <text>Make the records available to the patient on request, in compliance with applicable laws for disclosure of medical records;</text> </paragraph> <paragraph num="(6)"> <text>Make arrangements for another professional to provide for the needs of the patient during an anticipated absence when the licensee is unavailable to a patient;</text> </paragraph> <paragraph num="(7)"> <text>Make a referral only to other qualified and duly licensed health care providers;</text> </paragraph> <paragraph num="(8)"> <text>Accurately inform a patient, a health care professional, and the public of the limitations of the practice of acupuncture and make a referral to an appropriate health care practitioner as needed;</text> </paragraph> <paragraph num="(9)"> <text>Adequately assess the patient to determine whether a contraindication against acupuncture treatment exists before beginning treatment;</text> </paragraph> <paragraph num="(10)"> <text>Exercise independent professional judgement in the treatment and evaluation of a patient, regardless of whether the patient was referred by another health care provider; and</text> </paragraph> <paragraph num="(11)"> <text>Provide full notice to the patient that the patient would not reasonably be expected to benefit from the treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee may not:</text> <paragraph num="(1)"> <text>Accept a client for treatment, or continue unnecessary treatment, when the patient cannot be reasonably expected to benefit from the treatment;</text> </paragraph> <paragraph num="(2)"> <text>Receive remuneration from, or split a fee for, either making or accepting a referral of the patient to another health care practitioner;</text> </paragraph> <paragraph num="(3)"> <text>Make a guarantee or promise about the efficacy of a particular treatment, the licensee's practice, or the result of a treatment unless supported by scientific principles accepted by the profession; or</text> </paragraph> <paragraph num="(4)"> <text>Exploit the professional relationship by:</text> <paragraph num="(a)"> <text>Continuing treatment unnecessarily;</text> </paragraph> <paragraph num="(b)"> <text>Charging for a service:</text> <paragraph num="(i)"> <text>Not provided, or</text> </paragraph> <paragraph num="(ii)"> <text>Different from those actually provided.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Professional Boundaries."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship;</text> </paragraph> <paragraph num="(2)"> <text>Respect and maintain professional boundaries and respect the patient's reasonable expectation of professional conduct; and</text> </paragraph> <paragraph num="(3)"> <text>If the licensee and the patient mutually desire a personal relationship, immediately terminate the professional relationship, make an appropriate referral to another health care practitioner, and wait before engaging in such a relationship for a time when it is reasonably certain that the professional relationship has no influence on the personal relationship.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee may not:</text> <paragraph num="(1)"> <text>Exploit a relationship with a patient for the licensee's personal advantage, including, but not limited to, a personal, sexual, romantic, or financial relationship;</text> </paragraph> <paragraph num="(2)"> <text>Engage in a sexually intimate act with a patient; or</text> </paragraph> <paragraph num="(3)"> <text>Engage in sexual misconduct which includes behavior in which a licensee has engaged in sexual behavior with a patient in the context of a professional evaluation, treatment, procedure, or other service to the patient, regardless of the setting in which the professional service is provided.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records, Confidentiality, and Informed Consent."> <text>A licensee shall:</text> <paragraph num="A."> <text>Respect and maintain the privacy and confidentiality of the patient;</text> </paragraph> <paragraph num="B."> <text>Disclose the patient's record or information about the patient only with the patient's consent or as required by law;</text> </paragraph> <paragraph num="C."> <text>Adequately safeguard confidential patient information, including storage and disposal of records;</text> </paragraph> <paragraph num="D."> <text>Provide sufficient information to a patient to allow the patient to make an informed decision regarding treatment, including:</text> <paragraph num="(1)"> <text>The purpose and nature of an evaluation or treatment regimen,</text> </paragraph> <paragraph num="(2)"> <text>Alternatives to treatment,</text> </paragraph> <paragraph num="(3)"> <text>Side effects and benefits of a treatment regimen proposed and alternatives to that treatment,</text> </paragraph> <paragraph num="(4)"> <text>The estimated cost of treatment and alternatives to treatment,</text> </paragraph> <paragraph num="(5)"> <text>The right of the patient to withdraw from treatment at any time, including the risks associated with withdrawing from treatment, and</text> </paragraph> <paragraph num="(6)"> <text>The patient's right to decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Obtain the full informed consent of a patient participating in a human research program, without a direct or implied penalty for the patient's refusal to participate in the program, and with due regard for the patient's autonomy and dignity;</text> </paragraph> <paragraph num="F."> <text>Comply with applicable federal and State laws for human research programs;</text> </paragraph> <paragraph num="G."> <text>Maintain all patients' records in English; and</text> </paragraph> <paragraph num="H."> <text>If requested by the Board, provide an English language translation of the records by a Board approved translator, at the licensee's expense.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Education and Training."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Recognize the licensee's limitations and qualifications and practice acupuncture within the limits of these limitations and qualifications;</text> </paragraph> <paragraph num="(2)"> <text>Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and</text> </paragraph> <paragraph num="(3)"> <text>Be current in the licensee's qualifications to practice acupuncture, including meeting continuing education requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee may not perform a treatment or provide a service which the licensee is not qualified to perform or which is beyond the scope of the licensee's education, training, capabilities, experience, and scope of practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Advertising."> <paragraph num="A."> <text>A licensee may advertise services subject to the provisions of this regulation.</text> </paragraph> <paragraph num="B."> <text>A licensee may not use statements in an advertisement that:</text> <paragraph num="(1)"> <text>Contain a misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Are likely to mislead or deceive because, in context, the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Intend to or are likely to create a false or unjustified expectation of a favorable result;</text> </paragraph> <paragraph num="(4)"> <text>Relate to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully disclosing all relevant variables so that the statement would not be misunderstood or be deceptive to a layman;</text> </paragraph> <paragraph num="(5)"> <text>Convey the impression that the licensee could improperly influence a public body, official, corporation, or a person on behalf of a patient;</text> </paragraph> <paragraph num="(6)"> <text>Contain a representation that the licensee is willing to perform a procedure which is illegal; or</text> </paragraph> <paragraph num="(7)"> <text>Contain a representation or implication that, in reasonable probability, can be expected to cause an ordinarily prudent person to misunderstand or be deceived.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee is accountable under this regulation if the licensee uses an agent, partnership, professional association, or health maintenance organization to implement an action prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Ethical, Legal, and Professional Responsibilities."> <text>The licensee may not construe the failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and generally recognized in the profession.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1A-205 and 1A-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 18, 1999 (26:21 Md. R. 1630)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective October 1, 2001 (28:19 Md. R. 1685); February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G, H adopted effective April 11, 2005 (32:7 Md. R. 681); February 16, 2026 (53:3 Md. R. 122)</annotation> </annotations> </chapter> <chapter num="04" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Acupuncture Board and establishes the standards for use as a guide for the imposition of disciplinary sanctions against any Maryland licensed acupuncturist or any registered auricular detoxification specialist if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §1A–309, Annotated Code of Maryland, to place a licensee or registered auricular detoxification specialist on probation, reprimand, suspend, fine, or revoke a license. The Board may consider aggravating and mitigating factors in determining sanctions.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in cases which the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Advisory letter” means an informal action consisting of a nonpublic letter issued by the Board if the Board has a basis to charge the licensee with disciplinary violations, but closes the case by advising the licensee of the laws governing the practice of acupuncture.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Acupuncture Board.</text> </paragraph> <paragraph num="(6)"> <text>“Board counsel” means the attorney assigned by the Office of the Attorney General to provide legal advice to the Board, and to represent the Board in legal matters and suits filed against and on behalf of the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(8)"> <text>“Case resolution conference committee” means a committee composed of members of the Board who make recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(9)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board, ordering a licensee to cease from doing a specified activity or an unlicensed individual to cease the unauthorized practice of acupuncture.</text> </paragraph> <paragraph num="(10)"> <text>“Charging document” means a nonpublic document issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Acupuncture Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth sections of the Maryland Acupuncture Act the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Complaint.</text> <paragraph num="(a)"> <text>“Complaint” means a written document received by the Board which sets out conduct by a licensee which may violate the Maryland Acupuncture Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(b)"> <text>“Complaint” includes, but is not limited to:</text> <paragraph num="(i)"> <text>A consumer complaint;</text> </paragraph> <paragraph num="(ii)"> <text>A law enforcement report;</text> </paragraph> <paragraph num="(iii)"> <text>A report from a hospital or related institution;</text> </paragraph> <paragraph num="(iv)"> <text>A report from another state, country, or jurisdiction, or from the armed services of the United States;</text> </paragraph> <paragraph num="(v)"> <text>A report from an insurer;</text> </paragraph> <paragraph num="(vi)"> <text>A malpractice insurance report;</text> </paragraph> <paragraph num="(vii)"> <text>An advertisement;</text> </paragraph> <paragraph num="(viii)"> <text>A news article or report;</text> </paragraph> <paragraph num="(ix)"> <text>A webpage or other published content;</text> </paragraph> <paragraph num="(x)"> <text>A report from a professional association, peer review committee, rehabilitation committee, or medical review committee as defined in Health Occupations Article, §14-501, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(xi)"> <text>A report from another health occupation board or other State agency;</text> </paragraph> <paragraph num="(xii)"> <text>A report from a court of this or another jurisdiction;</text> </paragraph> <paragraph num="(xiii)"> <text>An application filed with the Board;</text> </paragraph> <paragraph num="(xiv)"> <text>A written memorandum of the Board alleging conduct by a licensee; and</text> </paragraph> <paragraph num="(xv)"> <text>Other information, from any other source, which warrants investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Complaint review committee” means the committee composed of Board members, Board staff, Board counsel, the administrative prosecutor, and other individuals designated by the Board to:</text> <paragraph num="(a)"> <text>Review complaints;</text> </paragraph> <paragraph num="(b)"> <text>Recommend to the Board that a matter be referred for investigation;</text> </paragraph> <paragraph num="(c)"> <text>Recommend to the Board that a matter be closed;</text> </paragraph> <paragraph num="(d)"> <text>Recommend to the Board that a licensee be charged with a violation of the Maryland Acupuncture Act or of an order of the Board;</text> </paragraph> <paragraph num="(e)"> <text>Recommend to the Board that the Board solicit a response from a licensee or respondent before further action; and</text> </paragraph> <paragraph num="(f)"> <text>Make recommendations to the Board regarding any other disciplinary matter which has been delegated to the complaint review committee by the Board.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Consent agreement” means informal action taken by the Board consisting of a nonpublic document which has been negotiated and agreed to by both the licensee and the Board to resolve an administrative, nondisciplinary matter.</text> </paragraph> <paragraph num="(14)"> <text>“Consent order” means a public document issued by the Board which is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(15)"> <text>“Contested case” means a proceeding conducted under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Disposition agreement” means a formal nonpublic agreement, entered into with an impaired licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(17)"> <text>“Final order” means a public document issued by the Board resolving a contested case either by consent or after an adjudication and which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board is authorized to do by law.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Imperatively requires emergency action” means a finding by the Board that an emergency action must be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(19)"> <text>“Informal action” means that the Board closes a case, without taking any formal disciplinary action or issuing a final order, by imposing a disciplinary sanction consisting of:</text> <paragraph num="(a)"> <text>A letter of education;</text> </paragraph> <paragraph num="(b)"> <text>An advisory letter;</text> </paragraph> <paragraph num="(c)"> <text>A letter of admonishment;</text> </paragraph> <paragraph num="(d)"> <text>A cease and desist letter; or</text> </paragraph> <paragraph num="(e)"> <text>A consent agreement.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Investigation” means the gathering of information about an applicant or after the Board receives a complaint against a licensee, which is necessary for the Board to determine whether there is reasonable cause to deny an application or charge a licensee with a violation of the Maryland Acupuncture Act.</text> </paragraph> <paragraph num="(21)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board, either before or after charges have been issued, if the Board believes a licensee has engaged in conduct which violates the Maryland Acupuncture Act but closes the case by admonishing the licensee.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may reflect agreement by the Board and the licensee that the licensee shall perform certain conditions instead of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Letter of education” means informal action consisting of a nonpublic letter:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Acupuncture Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee of the laws and standards of the practice of acupuncture.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender licensure to practice acupuncture, and which may include conditions for the Board's acceptance of the surrender as a resolution of the case instead of the Board taking formal disciplinary action.</text> </paragraph> <paragraph num="(24)"> <text>“Licensee” means an individual who is licensed to practice acupuncture in Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Licensure” means the authority granted to an individual by the Board pursuant to the Board's authority under the Maryland Acupuncture Act to practice acupuncture in this State.</text> </paragraph> <paragraph num="(26)"> <text>“Maryland Acupuncture Act” means Health Occupations Article, Title 1A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“Notice of initial denial” means a nonpublic document issued by the Board:</text> <paragraph num="(a)"> <text>By which an applicant or licensee is notified that the Board intends to deny a license, or a change in licensure status, or some other benefit sought by the licensee, and of the statutory grounds or other reasons for the denial; and</text> </paragraph> <paragraph num="(b)"> <text>Which provides notice to the licensee of any proceedings scheduled before the Board.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Post-deprivation hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(29)"> <text>“Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why the Board should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action which the Board is authorized by law to take.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Preliminary investigation” means the gathering of information necessary for the Board to determine whether the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Acupuncture Act.</text> </paragraph> <paragraph num="(31)"> <text>“Probation” means a sanction imposed by the Board in a public final order by which the public is notified that the licensee has violated the Maryland Acupuncture Act and the licensee is monitored by the Board for a period of time and must comply with certain conditions in order to avoid further disciplinary action.</text> </paragraph> <paragraph num="(32)"> <text>“Prohibited act” means any conduct specified in the Maryland Acupuncture Act which can result in sanctions or penalties.</text> </paragraph> <paragraph num="(33)"> <text>“Public document” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“Recommended decision” means a nonpublic document issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, and a proposed sanction, or any combination of these.</text> </paragraph> <paragraph num="(35)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or another reason which may interfere with the Board member's participation in a case.</text> </paragraph> <paragraph num="(36)"> <text>“Registered auricular detoxification specialist” means an individual who has been registered by the Board for the purpose of assisting an individual who is undergoing detoxification to remove addictive substances from the body and to restore health.</text> </paragraph> <paragraph num="(37)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, who has been:</text> <paragraph num="(a)"> <text>Charged with a violation of Health Occupations Article, §1A-309, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Notified that the Board intends to initially deny a license, change a licensee's status, or deny some other benefit sought by the licensee;</text> </paragraph> <paragraph num="(c)"> <text>Notified of a potential emergency suspension of the licensee's license; or</text> </paragraph> <paragraph num="(d)"> <text>Otherwise notified that the licensee has the opportunity to appear before the Board to respond to allegations by the Board in a contested case.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Reprimand” means a sanction imposed by the Board in a public final order if the Board determines that the licensee has violated the Maryland Acupuncture Act, which:</text> <paragraph num="(a)"> <text>Does not place the licensee on a period of probation;</text> </paragraph> <paragraph num="(b)"> <text>Permits the licensee to continue practicing without license suspension; and</text> </paragraph> <paragraph num="(c)"> <text>May be imposed in addition to any other sanctions authorized by the Act.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Revocation” means a sanction imposed by the Board in a public final order if the Board determines that the licensee has violated the Maryland Acupuncture Act, which terminates the licensee's authority to practice acupuncture and renders the licensee an unlicensed individual.</text> </paragraph> <paragraph num="(40)"> <text>“Sanction” means an action taken against a licensee by the Board in a public final order by which the public is notified that the licensee has violated the Maryland Acupuncture Act, and which may consist of a reprimand, probation, suspension or revocation of the license, or a fine.</text> </paragraph> <paragraph num="(41)"> <text>“Show cause hearing” means a nonevidentiary hearing held before the Board in which a licensee has an opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board is legally authorized to take.</text> </paragraph> <paragraph num="(42)"> <text>“Stay” means the withholding of an action ordered by the Board and which may be subject to certain conditions.</text> </paragraph> <paragraph num="(43)"> <text>“Stet” means the act of suspending all action in a proceeding, which may be subject to certain conditions, and which the Board has the discretion to reopen at a later time.</text> </paragraph> <paragraph num="(44)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(45)"> <text>“Surrender” means the voluntary relinquishing of a license to practice acupuncture which may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(46)"> <text>“Suspension” means a sanction imposed by the Board in a public final order if the Board determines that a licensee has violated the Maryland Acupuncture Act, which temporarily discontinues the licensee's authority to practice acupuncture for a specific period of time or until certain conditions are met.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The confidentiality may not be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>Office of Administrative Hearing proceedings involving the adjudication of a Board contested case and the administrative law judge's recommended decision are confidential, and the respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, both before and after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, a respondent shall be represented by the respondent, or by an attorney who is admitted to the Maryland Bar or specially admitted to practice law pursuant to Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>An administrative prosecutor assigned to the Board by the Office of the Attorney General shall prosecute disciplinary matters in Board proceedings.</text> </paragraph> <paragraph num="D."> <text>The Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General in all proceedings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings Under Health Occupations Article, §1A-309, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board executive director may make a preliminary review of each complaint and may recommend to the Board that cases involving complaints over which the Board has no jurisdiction be closed.</text> </paragraph> <paragraph num="(2)"> <text>The Board's complaint review committee shall review complaints over which the Board has jurisdiction and make a recommendation to the Board as to the disposition of each complaint.</text> </paragraph> <paragraph num="(3)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee who is the subject of the complaint to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(4)"> <text>Participation in review of complaints made to the Board is not ordinarily a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in the case.</text> </paragraph> <paragraph num="(5)"> <text>The Board may issue subpoenas over the signature of the Board's executive director or a Board member.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>For each complaint, after reviewing any completed investigative information or reports and considering the recommendation of the complaint review committee, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case;</text> </paragraph> <paragraph num="(c)"> <text>Refer the case to peer review for mediation;</text> </paragraph> <paragraph num="(d)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(e)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(f)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(g)"> <text>Refer the matter to the administrative prosecutor; or</text> </paragraph> <paragraph num="(h)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §1A-309, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether the Board has voted to charge a licensee with a violation of the Maryland Acupuncture Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be served upon the respondent.</text> </paragraph> <paragraph num="(2)"> <text>Service is completed when the document is:</text> <paragraph num="(a)"> <text>Sent by U.S. first-class mail;</text> </paragraph> <paragraph num="(b)"> <text>Sent by certified mail to the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(c)"> <text>Hand delivered in-person or by courier; or</text> </paragraph> <paragraph num="(d)"> <text>Sent by electronic means with a read receipt.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Acupuncture Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing; and</text> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying the respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the respondent has not acknowledged receipt of the charges or notice of initial denial, the Board may nevertheless proceed in prosecuting the case if it has complied with §C(2) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption shall satisfy the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(a)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and consistent with COMAR 28.02.01;</text> </paragraph> <paragraph num="(b)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>The Board may deny a respondent's request for a case resolution conference except as provided in §E(1) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="(5)"> <text>The Board is not bound by the recommendations of the case resolution conference committee and may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If either the respondent or administrative prosecutor disagree with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>If a respondent offers to surrender licensure after the initiation of an investigation, before or after service of charges, or instead of any or further disciplinary action, the Board may require conditions for the surrender of the license.</text> </paragraph> <paragraph num="(2)"> <text>The Board may require conditions for surrender of a license, including, but not limited to:</text> <paragraph num="(a)"> <text>The admission of a violation of the Maryland Acupuncture Act;</text> </paragraph> <paragraph num="(b)"> <text>The admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not again apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A letter of surrender is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland, unless the Board determines that disclosure of the surrender is not in the public interest.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings of the Board delegated to the Office of Administrative Hearings shall be conducted under this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Proceedings are not open to the public and all records, including the recommended decision, shall be treated as confidential and sealed.</text> </paragraph> <paragraph num="(5)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §B(5)(a) — (c) of this regulation under the Board's delegation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>In proceedings before the Board, the Board's counsel may advise the Board on issues of law in the course of the proceedings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>A licensee against whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Acupuncture Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, each party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages. The exceptions shall state with particularity:</text> <paragraph num="(a)"> <text>The findings of fact, conclusions of law, or other matter excepted to; and</text> </paragraph> <paragraph num="(b)"> <text>The relevant portions of the record supporting the party's exception.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party's response to an answer to exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board following receipt of the parties' exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in exceptions, any answer to exceptions, or in the hearing on exceptions, reference any document or other evidence or offer any exhibit that is outside the record of the evidentiary hearing before either the Board or the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>If the hearing followed charges, the Board may order the dismissal of the charges, or, if it determines there has been a violation of the Maryland Acupuncture Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked.</text> </paragraph> <paragraph num="(3)"> <text>If the hearing followed a notice of initial denial of license, the Board may order the grant or denial of a license.</text> </paragraph> <paragraph num="(4)"> <text>Within 15 days after the Board issues a final order, either party may file a motion for reconsideration with the Board, which may be granted at the Board's discretion.</text> </paragraph> <paragraph num="(5)"> <text>There is no automatic right to a hearing on a party's motion for reconsideration, and the Board has the discretion to request a response to the motion from the opposing party.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board may order the summary suspension of a license if it determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of an intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of an intent to summarily suspend a license or an order of summary suspension, it shall refer the matter to the administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include, but is not limited to:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and which includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By any other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity To Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before it executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>A Predeprivation Show Cause Hearing before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the presiding Board member believes that the documents or exhibits are necessary in order for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension of a License without Prior Notice or an Opportunity To Be Heard.</text> <paragraph num="(1)"> <text>In extraordinary circumstances, the Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend the license or providing a respondent with an opportunity for a predeprivation hearing if:</text> <paragraph num="(a)"> <text>The Board determines that the public health, safety, or welfare requires the immediate suspension of the license and that prior notice and an opportunity to be heard is not feasible;</text> </paragraph> <paragraph num="(b)"> <text>The order of summary suspension is served upon the respondent within 24 hours after its execution; and</text> </paragraph> <paragraph num="(c)"> <text>The respondent is provided with an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the respondent requests a hearing under §D(1)(c) of this regulation, the hearing shall be conducted before the Board as provided in §C(2) of this regulation and shall provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrates that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the public health, safety, or welfare imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, it may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Post-Deprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license under §C or D of this regulation, the respondent may have an evidentiary hearing before the Board or before an administrative law judge, if the Board delegates the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after respondent's request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board has delegated the matter to the Office of Administrative Hearings, the administrative law judge shall issue to the Board a recommended decision with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a) — (c) of this regulation under the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge's determination as to the merits of the summary suspension shall be based only on those parts of the record that were available to the Board at the time it voted for the summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exceptions to the recommended decision as provided in State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a post-deprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board determines to be appropriate, including:</text> <paragraph num="(1)"> <text>Reeducation or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Donation to an approved institution providing acupuncture services for the poor, indigent, or handicapped;</text> </paragraph> <paragraph num="(4)"> <text>Providing free acupuncture services in a Board-approved program;</text> </paragraph> <paragraph num="(5)"> <text>Entering into and complying with a contract with an addiction treatment program;</text> </paragraph> <paragraph num="(6)"> <text>Practice supervision;</text> </paragraph> <paragraph num="(7)"> <text>Monitoring by the Board or by an individual or entity chosen or approved by the Board and periodic reporting to the Board;</text> </paragraph> <paragraph num="(8)"> <text>Periodic review of a licensee's clinical practice;</text> </paragraph> <paragraph num="(9)"> <text>Periodic review or audit, or both, of a licensee's billing practices;</text> </paragraph> <paragraph num="(10)"> <text>An examination by a physician or appropriate health care provider;</text> </paragraph> <paragraph num="(11)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(12)"> <text>Achieving a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(13)"> <text>Any other condition the Board determines to be appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board for probation:</text> <paragraph num="(1)"> <text>When the specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>After the licensee has successfully completed the conditions or acts required for termination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If at any time the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action provided for in the final order or consent order in the event of a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and which it is authorized to do by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts which the Board believes constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing.</text> <paragraph num="(1)"> <text>Unless otherwise determined by the Board, a hearing for a violation of probation shall be held before the Board.</text> </paragraph> <paragraph num="(2)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the charge that the licensee has violated probation.</text> </paragraph> <paragraph num="(3)"> <text>The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(4)"> <text>The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(5)"> <text>The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument.</text> </paragraph> <paragraph num="(6)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> <paragraph num="(7)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the Board member believes that the documents or exhibits are necessary in order for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness, unless the parties agree and the Board approves before the hearing.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> <paragraph num="(9)"> <text>If the Board believes that the issues in the case warrant it, the Board may provide a respondent with an evidentiary hearing, either before the Board or an administrative law judge if the Board delegates the matter to Office of Administrative Hearings, which may be instead of or after a nonevidentiary violation of probation hearing held before the Board.</text> </paragraph> <paragraph num="(10)"> <text>The Board may consider the complexity of the case, the need for testimony or admission of other evidence, or any other factor it considers appropriate in determining whether to provide a respondent with an evidentiary violation of probation hearing.</text> </paragraph> <paragraph num="(11)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="G."> <text>After a hearing, the Board shall issue a final order consisting of findings of fact, conclusions of law, and an order that is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> <paragraph num="H."> <text>If the Board determines that respondent has violated probation, the Board may:</text> <paragraph num="(1)"> <text>Take any action provided for in the consent order or final order in the event of a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose any sanction or take any other action that the Board considers appropriate and is authorized to do by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reinstatement of a License."> <paragraph num="A."> <text>Petition for Reinstatement.</text> <paragraph num="(1)"> <text>A licensee who seeks reinstatement after suspension, revocation, or surrender of a license, or whose reinstatement involves a disciplinary issue, shall petition the Board for reinstatement.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not consider a petition for reinstatement after the revocation of a license before 1 year after the effective date of the revocation, unless otherwise specified in the final order.</text> </paragraph> <paragraph num="(3)"> <text>A licensee who petitions the Board for reinstatement under terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(4)"> <text>A licensee whose license has been revoked or surrendered for 3 or more years before filing a petition for reinstatement is not eligible for reinstatement but may apply for an initial license.</text> </paragraph> <paragraph num="(5)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement set out in COMAR 10.26.02; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain completion of required continuing education credits as if the licensee had been continually licensed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Opportunity for a Hearing.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the Board's legal basis for the Board's belief that the respondent is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts which the Board believes supports the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference to discuss settlement of the matter as provided in Regulation .05E of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or be delegated to an administrative law judge and conducted under the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, the Board may impose any restrictions or conditions on the license or the licensee's practice that the Board considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>General Application.</text> <paragraph num="(1)"> <text>This regulation shall be used by the Board as a guide for sanctioning licensees pursuant to its authority under Health Occupations Article, §§1A-205 and 1A-309, Annotated Code of Maryland, for violations of the Acupuncture Act and the Board's regulations.</text> </paragraph> <paragraph num="(2)"> <text>The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines.</text> </paragraph> <paragraph num="(3)"> <text>A departure from the sanctioning guidelines alone is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="(4)"> <text>Notwithstanding these sanctioning guidelines, in order to resolve a disciplinary matter, the Board and the licensee or registered detoxification specialist may agree to surrender a license or registration or to a Consent Order with terms, conditions, and sanctions agreed upon.</text> </paragraph> <paragraph num="(5)"> <text>In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation.</text> </paragraph> <paragraph num="(6)"> <text>If probation is imposed, the Board may impose appropriate terms and conditions of probation, and, if a licensee or registration holder violates the terms or conditions of probation, the Board may take further disciplinary action against the individual.</text> </paragraph> <paragraph num="(7)"> <text>In the event a violation does not fall within the sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and shall consider, to the extent possible, the factors in the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> <paragraph num="C."> <text>Mitigating and Aggravating Factors. Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside of the range of sanctions established by the guidelines. These factors may include, but are not limited to the following:</text> <paragraph num="(1)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The licensee reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The licensee voluntarily admitted violation, provided full disclosure to the Board, and cooperated during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The licensee implemented remedial measures to correct or mitigate harm arising from the violation;</text> </paragraph> <paragraph num="(e)"> <text>The licensee made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of rehabilitation or potential for rehabilitation;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the violation;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to or adverse impact on the public;</text> </paragraph> <paragraph num="(i)"> <text>Isolated incident and not likely to recur; and</text> </paragraph> <paragraph num="(j)"> <text>The licensee’s prior community service and present value to the community.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The licensee was motivated to perform the violation by his or her financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the patient;</text> </paragraph> <paragraph num="(g)"> <text>The licensee attempted to conceal the violation, falsified or destroyed evidence, or presented false testimony or evidence;</text> </paragraph> <paragraph num="(h)"> <text>The licensee failed to cooperate with the Boards investigation; and</text> </paragraph> <paragraph num="(i)"> <text>Previous attempts at rehabilitation were unsuccessful.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §1A-311, and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Imposition of Penalties."> <paragraph num="A."> <text>The Board may impose a civil monetary penalty instead of or in addition to a disciplinary sanction authorized by Health Occupations Article, §1A-309, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Practicing on an Expired License.</text> <paragraph num="(1)"> <text>The Board may impose a civil fine against an acupuncturist who practices acupuncture on an expired license in the amount of $100 per day not to exceed $5,000.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not impose a fine under §B(1) of this regulation against an acupuncturist for practicing acupuncture on an expired license if the acupuncturist’s license is reinstated within 30 calendar days of the expiration date of the license and the licensee complies with COMAR 10.26.02.05D.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Practicing Without a License or Misrepresentation.</text> <paragraph num="(1)"> <text>The Board may impose a civil fine of no less than $5,000 and no more than $50,000 against an individual who practices acupuncture without a license or represents to the public, by description of services, methods, or procedures, or otherwise, that the individual is authorized to practice acupuncture in this State.</text> </paragraph> <paragraph num="(2)"> <text>Factors determining the amount of the fine include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The extent to which the individual derived any financial benefit from the unauthorized practice;</text> </paragraph> <paragraph num="(b)"> <text>The willfulness of the unauthorized practice;</text> </paragraph> <paragraph num="(c)"> <text>Actual or potential harm caused by the unauthorized practice;</text> </paragraph> <paragraph num="(d)"> <text>The length of time in which the individual engaged in the unauthorized practice; and</text> </paragraph> <paragraph num="(e)"> <text>The cost of any Board investigation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Consideration and Notice of Board Files."> <text>In any matter governed by this chapter, the Board may consider or take official notice, or both, of any information contained in the Board's files.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Hearing Costs."> <paragraph num="A."> <text>If, after a hearing, a licensee is found to have violated provisions of Health Occupations Article, §1A-309, Annotated Code of Maryland, the Board shall impose a fee on the licensee that shall approximate the Board's cost of bringing the proceedings against the licensee.</text> </paragraph> <paragraph num="B."> <text>The hearing costs may include any or all of the following expense items:</text> <paragraph num="(1)"> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="(2)"> <text>Transcriptions of the hearing record by court reporters;</text> </paragraph> <paragraph num="(3)"> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="(4)"> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="(5)"> <text>Hearing-related per diems and expenses for Board members; or</text> </paragraph> <paragraph num="(6)"> <text>Any other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1A-205, 1A-309, 1A-310, and 1A-314;State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 22, 2002 (29:14 Md. R. 1075)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 20, 2012 (39:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 13, 2015 (42:7 Md. R. 569)</annotation> </annotations> </chapter> <chapter num="05" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prohibit or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §10-617(h)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 2001 (28:19 Md. R. 1685)</annotation> </annotations> </chapter> <chapter num="06" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This regulation governs all acupuncturists licensed to practice in the State of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Board” means the State Board of Acupuncture.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Renewal."> <paragraph num="A."> <text>A licensee applying for renewal shall complete 30 hours of relevant continuing education during the 2-year period preceding the expiration of the license which include the following:</text> <paragraph num="(1)"> <text>At least 20 hours in formally organized programs approved by the Board which are relevant to the practice of acupuncture and East Asian medicine;</text> </paragraph> <paragraph num="(2)"> <text>Not more than 10 hours of formally organized training programs in Western science and medical practices, medical ethics, medical research, or cardiopulmonary resuscitation which are relevant to the practice of acupuncture and East Asian medicine;</text> </paragraph> <paragraph num="(3)"> <text>Not more than 10 hours of training in approved programs which will assist a licensee to carry out the licensee’s professional responsibilities, including, but not limited to:</text> <paragraph num="(a)"> <text>Management courses for a school administrator;</text> </paragraph> <paragraph num="(b)"> <text>Foreign language training for translators of relevant texts; or</text> </paragraph> <paragraph num="(c)"> <text>Educational methodology for teachers of acupuncture;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Not more than 10 hours teaching acupuncture and related East Asian medical therapies in an accredited school or in a program approved for acupuncture continuing education;</text> </paragraph> <paragraph num="(5)"> <text>Not more than 7 hours of pro bono work as outlined in §B of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Not more than 7 hours in published writing or articles in acupuncture and East Asian medicine that are:</text> <paragraph num="(a)"> <text>Peer-reviewed research or peer-reviewed clinically relevant articles in acupuncture and East Asian medicine; and</text> </paragraph> <paragraph num="(b)"> <text>Limited to 4 hours per article;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Not more than 20 hours for passage of the NCCAOM exam within the 2-year period preceding the expiration of the license; or</text> </paragraph> <paragraph num="(8)"> <text>Not more than 10 hours serving on a professional board involving:</text> <paragraph num="(a)"> <text>Acupuncture; or</text> </paragraph> <paragraph num="(b)"> <text>East Asian medicine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Pro Bono Work.</text> <paragraph num="(1)"> <text>Pro bono work shall:</text> <paragraph num="(a)"> <text>Earn 1 credit hour for each 3 hours of pro bono activity up to a maximum of 7 credit hours per renewal cycle; and</text> </paragraph> <paragraph num="(b)"> <text>Be for the provision of acupuncture services provided through an organization offering humanitarian services such as, but not limited to:</text> <paragraph num="(i)"> <text>Domestic or international victims in an emergency situation or disaster area;</text> </paragraph> <paragraph num="(ii)"> <text>Low-income or underserved areas or populations;</text> </paragraph> <paragraph num="(iii)"> <text>Special needs populations; or</text> </paragraph> <paragraph num="(iv)"> <text>United States military personnel.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon completion of the pro bono work, the licensee shall obtain from the facility written documentation of completion of pro bono hours, including:</text> <paragraph num="(a)"> <text>The name of the facility;</text> </paragraph> <paragraph num="(b)"> <text>The address where the pro bono work was provided;</text> </paragraph> <paragraph num="(c)"> <text>The type of work that was done;</text> </paragraph> <paragraph num="(d)"> <text>The number of hours of actual work provided for which the licensee desires credit hours; and</text> </paragraph> <paragraph num="(e)"> <text>A statement guaranteeing that the work provided no financial benefit to the licensee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Licensees shall maintain the documentation of their continuing education credits for 4 years from the date of their acupuncture renewal.</text> </paragraph> <paragraph num="D."> <text>If requested by the Board, a licensee shall provide proof of continuing education attendance by providing documentation of:</text> <paragraph num="(1)"> <text>Name of the program;</text> </paragraph> <paragraph num="(2)"> <text>Date of the program;</text> </paragraph> <paragraph num="(3)"> <text>Number of continuing education hours earned; and</text> </paragraph> <paragraph num="(4)"> <text>Name of the sponsoring organization.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1A-205 and 1A-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 16, 2023 (50:20 Md. R. 887)</annotation> </annotations> </chapter> </subtitle> <subtitle num="27" heading="Board of Nursing"> <chapter num="01" heading="Examination and Licensure"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Active nursing practice” as used in Health Occupations Article, §8-312, Annotated Code of Maryland, means:</text> <paragraph num="(a)"> <text>The practice of registered nursing or licensed practical nursing as defined in Health Occupations Article, §8-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Related nursing activities approved by the Board, including but not limited to a generic nursing education program, degree completion programs, or graduate programs within the last 5 years; and</text> </paragraph> <paragraph num="(c)"> <text>Completion of a generic nursing education program, degree completion program, or a graduate program within the last 5 years.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Advanced practice registered nurse” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Biennial renewal” means renewal of a license every 2 years in the licensee’s birth month.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>“Central Repository” means the Maryland Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(6)"> <text>“Certified nursing assistant (CNA)” has the meaning stated in Health Occupations Article, §8-6A-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Continuing education” means planned, organized learning experiences designed to augment the knowledge, skill, and ability to enhance nursing practice and therefore improve health care delivered to the public.</text> </paragraph> <paragraph num="(8)"> <text>“Continuing education unit (CEU)” means 1 contact hour of 50—60 minutes.</text> </paragraph> <paragraph num="(9)"> <text>“Cosign” means a registered nurse verifies that:</text> <paragraph num="(a)"> <text>An activity was performed safely and accurately by the nursing graduate; and</text> </paragraph> <paragraph num="(b)"> <text>The documentation is complete and accurate.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Criminal history records check” means the performance of both a State criminal history check by the Central Repository, and a national criminal history check by the Federal Bureau of Investigation (FBI).</text> </paragraph> <paragraph num="(11)"> <text>“Criminal history records information” means information provided by the criminal history records check regarding an applicant's criminal arrests, charges, and convictions, and other dispositions of criminal charges.</text> </paragraph> <paragraph num="(12)"> <text>“Direct patient care” means healthcare activities that involve direct interaction between a healthcare professional and a patient.</text> </paragraph> <paragraph num="(13)"> <text>“Endorsement” means, for qualified applicants who have an unencumbered license from another state or country to practice registered nursing or licensed practical nursing, a waiver of the initial licensure requirement to take the national licensure examination in accordance with Health Occupations Article, §8-307, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“English language competency examination” means an examination that tests an individual’s written and oral competency in the English language.</text> </paragraph> <paragraph num="(15)"> <text>Entry-level Registered Nursing Education Program.</text> <paragraph num="(a)"> <text>“Entry-level registered nursing education program” means a registered nursing education program that is the initial entry point for formal registered nursing education that, upon successful completion, qualifies an individual with no prior registered nursing education to obtain licensure as a registered nurse.</text> </paragraph> <paragraph num="(b)"> <text>“Entry-level registered nursing education program” does not include degree completion programs, including but not limited to:</text> <paragraph num="(i)"> <text>Associate of Applied Science Degree in Nursing to Baccalaureate of Science Degree in Nursing (AAS-BSN);</text> </paragraph> <paragraph num="(ii)"> <text>Associate of Degree in Nursing to Baccalaureate of Science Degree in Nursing (ADN-BSN);</text> </paragraph> <paragraph num="(iii)"> <text>Associate of Applied Science Degree in Nursing to Masters of Science Degree in Nursing (AAS-MSN);</text> </paragraph> <paragraph num="(iv)"> <text>Associate Degree in Nursing to Masters of Science Degree in Nursing (ADN-MSN);</text> </paragraph> <paragraph num="(v)"> <text>Baccalaureate of Science Degree in Nursing to Masters of Science Degree in Nursing (BSN-MSN);</text> </paragraph> <paragraph num="(vi)"> <text>Baccalaureate of Science Degree in Nursing to Doctor of Philosophy (BSN-PHD);</text> </paragraph> <paragraph num="(vii)"> <text>Baccalaureate of Science Degree in Nursing to Doctor of Education (BSN-EDD);</text> </paragraph> <paragraph num="(viii)"> <text>Baccalaureate of Science Degree in Nursing to Doctor of Nursing Practice (BSN-DNP);</text> </paragraph> <paragraph num="(ix)"> <text>Masters of Science Degree in Nursing to Doctor of Philosophy (MSN-PHD);</text> </paragraph> <paragraph num="(x)"> <text>Masters of Science Degree in Nursing to Doctor of Education (MSN-EDD);</text> </paragraph> <paragraph num="(xi)"> <text>Masters of Science Degree in Nursing to Doctor of Nursing Practice (MSN-DNP); or</text> </paragraph> <paragraph num="(xii)"> <text>Masters of Science Degree in Nursing to Post Masters Certificate/Post Graduate Certificate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Former licensee” means an individual who once had an active license with the Board who is no longer active.</text> </paragraph> <paragraph num="(17)"> <text>“Multistate licensure privilege” means an authorization to practice registered nursing or licensed practical nursing in Maryland that is granted to a registered nurse or licensed practical nurse who has an active multistate license issued by another state in accordance with the Nurse Licensure Compact.</text> </paragraph> <paragraph num="(18)"> <text>“NCLEX” means the National Council Licensure Examination for initial licensure as a registered nurse or licensed practical nurse.</text> </paragraph> <paragraph num="(19)"> <text>“Nursing assistant” means an individual certified by the Board as a certified nursing assistant.</text> </paragraph> <paragraph num="(20)"> <text>“Preceptor” means a registered nurse who meets the qualifications of faculty as described in Regulation .16 of this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Preceptorship” means an individualized refresher course approved by the Board and offered by an institution employing nurses which complies with Regulation .16 of this chapter.</text> </paragraph> <paragraph num="(22)"> <text>“Student” means a registered nurse or licensed practical nurse who is required to complete a refresher course in order to maintain or reestablish an active license.</text> </paragraph> <paragraph num="(23)"> <text>“Substantially equivalent” has the meaning stated in §§C and D of this regulation.</text> </paragraph> <paragraph num="(24)"> <text>“Volunteer” means a licensee who, at the time of licensure renewal, elects to receive a license which only allows the licensee to provide professional services without remuneration.</text> </paragraph> <paragraph num="(25)"> <text>“Written and oral competency in the English language” means the ability to demonstrate proficiency in listening, reading, speaking, and writing the English language.</text> </paragraph> </paragraph> <paragraph num="C."> <text>“Substantially equivalent” means a registered nursing or licensed practical nursing education program that:</text> <paragraph num="(1)"> <text>Contains theoretical learning experiences and related clinical learning experiences that include direct patient care within various settings consistent with program objectives, outcomes, or competencies conducted either concurrently with or after the theoretical learning experience; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the curriculum requirements for Maryland schools of nursing at the time of the applicant’s graduation, including, but not limited to:</text> <paragraph num="(a)"> <text>The appropriate level of the graduate's intended scope of practice;</text> </paragraph> <paragraph num="(b)"> <text>Didactic and clinical learning experiences that are diverse and consistent with program objectives, outcomes, or competencies;</text> </paragraph> <paragraph num="(c)"> <text>Didactic and clinical instruction in nursing care of families and clients throughout the life span in a variety of care settings requiring nursing measures appropriate for:</text> <paragraph num="(i)"> <text>The maintenance or restoration of mental and physical health;</text> </paragraph> <paragraph num="(ii)"> <text>Preventive, rehabilitative, and curative aspects of health care;</text> </paragraph> <paragraph num="(iii)"> <text>Biophysical, psychosocial, cultural, and spiritual components of health and illness; and</text> </paragraph> <paragraph num="(iv)"> <text>Professional issues content; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Didactic and clinical instructional content that includes, but is not limited to, the areas of:</text> <paragraph num="(i)"> <text>Medical and surgical nursing;</text> </paragraph> <paragraph num="(ii)"> <text>Maternal and child health;</text> </paragraph> <paragraph num="(iii)"> <text>Psychiatric nursing; and</text> </paragraph> <paragraph num="(iv)"> <text>Geriatric nursing.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>“Substantially equivalent” does not mean a registered nurse or licensed practical nursing education program in another state or country that does not have a supervised clinical learning experience requirement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>The fees listed in this regulation are not refundable.</text> </paragraph> <paragraph num="B."> <text>Licensure by examination fees are as follows:</text> <paragraph num="(1)"> <text>Registered nurse licensure — $187;</text> </paragraph> <paragraph num="(2)"> <text>Licensed practical nurse licensure — $187; and</text> </paragraph> <paragraph num="(3)"> <text>An examination fee for registered nurse and licensed practical nurse licensure shall be paid by the candidate directly to the testing service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Licensure by endorsement fees are as follows:</text> <paragraph num="(1)"> <text>Registered nurse licensure — $230; and</text> </paragraph> <paragraph num="(2)"> <text>Licensed practical nurse licensure — $230.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Temporary registered nurse or licensed practical nurse licensure fee —$70.</text> </paragraph> <paragraph num="E."> <text>Advanced practice registered nurse certification fees are as follows:</text> <paragraph num="(1)"> <text>Initial advanced practice certification — $50; and</text> </paragraph> <paragraph num="(2)"> <text>Each additional initial advanced practice certification — $25.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Specialty nursing practice certification fees are as follows:</text> <paragraph num="(1)"> <text>Initial forensic nurse examiner certification — $25; and</text> </paragraph> <paragraph num="(2)"> <text>Initial workers’ compensation medical case manager certification — $25.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Biennial renewal fees are as follows:</text> <paragraph num="(1)"> <text>Renewal of a registered nurse license — $165;</text> </paragraph> <paragraph num="(2)"> <text>Renewal of a licensed practical nurse license — $165;</text> </paragraph> <paragraph num="(3)"> <text>Renewal of a registered nurse or licensed practical nurse volunteer license — $73;</text> </paragraph> <paragraph num="(4)"> <text>Renewal of an inactive license for a registered nurse or licensed practical nurse — $60;</text> </paragraph> <paragraph num="(5)"> <text>Renewal of each advanced practice registered nurse certification is in addition to the registered nurse license renewal fee and is — $10; and</text> </paragraph> <paragraph num="(6)"> <text>Renewal of certification for specialty nursing practices regulated by the Board is in addition to the registered nurse license renewal fee and is as follows:</text> <paragraph num="(a)"> <text>Forensic nurse examiner certification — $10; and</text> </paragraph> <paragraph num="(b)"> <text>Workers’ compensation medical case manager certification — $10.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Health Care Practitioner User Fee.</text> <paragraph num="(1)"> <text>In addition to a license fee, each registered nurse shall pay a non-refundable health care practitioner user fee assessed by the Maryland Health Care Commission in accordance with Health-General Article, §19-111(b)(4), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The health care practitioner user fee shall be:</text> <paragraph num="(a)"> <text>Included in the licensing fee paid to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Collected with the application for an initial or renewal license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The amount of the assessed health care practitioner user fee shall be double the amount of the annual health care practitioner user fee for biennial licensure.</text> </paragraph> <paragraph num="(4)"> <text>The Board shall:</text> <paragraph num="(a)"> <text>Account for the user fees; and</text> </paragraph> <paragraph num="(b)"> <text>Transfer the fees to the Maryland Health Care Commission on a quarterly basis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Nurse Practitioner Preceptorship Tax Credit Fund.</text> <paragraph num="(1)"> <text>This fee applies only to nurse practitioners.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall assess a separate $15 fee for the renewal of a nurse practitioner, regardless of the number of certifications held by the nurse practitioner.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall:</text> <paragraph num="(a)"> <text>Account for the fees collected under this section; and</text> </paragraph> <paragraph num="(b)"> <text>Transfer the fee to the Nurse Practitioner Preceptorship Tax Credit Fund.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Other fees are as follows:</text> <paragraph num="(1)"> <text>Verification of licensure — $45;</text> </paragraph> <paragraph num="(2)"> <text>Copies of transcripts — $25; and</text> </paragraph> <paragraph num="(3)"> <text>Returned check fee —$30.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Exceptions."> <paragraph num="A."> <text>Registered nurses or licensed practical nurses who hold a current active license in any other state or jurisdiction may render nursing care:</text> <paragraph num="(1)"> <text>For not more than 30 days, to an individual who is visiting the State for medical, educational, or personal reasons;</text> </paragraph> <paragraph num="(2)"> <text>For the purpose of the interstate transport and care of patients traveling to and from Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>During an emergency situation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A registered nurse or licensed practical nurse who holds a multistate licensure privilege under the Nurse Licensure Compact may practice nursing in this State in accordance with the laws of this State.</text> </paragraph> <paragraph num="C."> <text>Nursing Graduate.</text> <paragraph num="(1)"> <text>A nursing graduate is a graduate of:</text> <paragraph num="(a)"> <text>A Board-approved registered nursing or licensed practical nursing education program; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-state nursing education program determined to be equivalent by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A nursing graduate may practice as set forth in §C(5)—(7) of this regulation if:</text> <paragraph num="(a)"> <text>The nursing graduate has an application for a license pending before the Board; and</text> </paragraph> <paragraph num="(b)"> <text>One of the following circumstances exists:</text> <paragraph num="(i)"> <text>The nursing graduate has not taken the NCLEX examination;</text> </paragraph> <paragraph num="(ii)"> <text>The nursing graduate has taken the NCLEX examination, but the results of the NCLEX examination are not yet known;</text> </paragraph> <paragraph num="(iii)"> <text>The nursing graduate has taken and passed the NCLEX examination but is waiting for the completion of the criminal history records check; or</text> </paragraph> <paragraph num="(iv)"> <text>The nursing graduate has taken and failed the NCLEX examination but has not failed the NCLEX examination more than one time within the 120 day period immediately following the submission of the application to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A nursing graduate shall cease practice as a nursing graduate:</text> <paragraph num="(a)"> <text>No later than 120 days after the date the nursing graduate submitted an application to the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately if the nursing graduate fails the second NCLEX examination.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the nursing graduate fails the NCLEX examination, the nursing graduate may practice as a nursing assistant provided the individual obtains certification as a nursing assistant and practices according to COMAR 10.39.01.</text> </paragraph> <paragraph num="(5)"> <text>A nursing graduate shall:</text> <paragraph num="(a)"> <text>Practice only under the direct supervision of a registered nurse who is physically present on the unit to:</text> <paragraph num="(i)"> <text>Cosign medication transcription, medication administration, and nursing documentation; and</text> </paragraph> <paragraph num="(ii)"> <text>Continually observe, assist, coordinate, evaluate, and monitor the nursing graduate; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Use the initials “NG” after the nursing graduate's name as credentials.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>After successful completion of an organized staff development program which includes an evaluation that the nursing graduate is competent and in compliance with §C(5) of this regulation, the nursing graduate may:</text> <paragraph num="(a)"> <text>Transcribe medication orders if:</text> <paragraph num="(i)"> <text>Written policies and procedures are available on the unit of care; and</text> </paragraph> <paragraph num="(ii)"> <text>An organized staff development program which includes skill validation has been successfully completed by the nursing graduate;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>After competency has been validated by the facility:</text> <paragraph num="(i)"> <text>Administer medications and controlled substances; and</text> </paragraph> <paragraph num="(ii)"> <text>Sign controlled substances sheets;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Document in the medical record with the abbreviation “NG”;</text> </paragraph> <paragraph num="(d)"> <text>Perform patient assessments after the initial assessment or after the first assessment of the shift performed by the registered nurse; and</text> </paragraph> <paragraph num="(e)"> <text>Perform and document routine procedures taught within the nursing graduate's generic nursing program, including but not limited to:</text> <paragraph num="(i)"> <text>Placing nasal gastric tubes;</text> </paragraph> <paragraph num="(ii)"> <text>Performing urinary catheterizations;</text> </paragraph> <paragraph num="(iii)"> <text>Applying sterile dressings;</text> </paragraph> <paragraph num="(iv)"> <text>Performing blood sugar checks; and</text> </paragraph> <paragraph num="(v)"> <text>Obtaining specimens.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>A nursing graduate may not:</text> <paragraph num="(a)"> <text>Work without the physical presence of and direct supervision by a registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Refer to oneself or practice as a registered nurse (RN) or licensed practical nurse (LPN);</text> </paragraph> <paragraph num="(c)"> <text>Be considered a staff person for purposes of a staffing pattern;</text> </paragraph> <paragraph num="(d)"> <text>Accept charge responsibilities; or</text> </paragraph> <paragraph num="(e)"> <text>Perform initial patient assessment or the first patient assessment of a shift, develop patient plans of care, evaluate or document patient discharge, or independently administer medications or intravenous therapy.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Provisions for Applications."> <paragraph num="A."> <text>An applicant shall submit:</text> <paragraph num="(1)"> <text>A completed application to the Board on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>To a criminal history records check (CHRC) in accordance with Health Occupations Article, §8–303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Written evidence satisfactory to the Board that the applicant has submitted to a CHRC as required by §A(2) of this regulation by submitting:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the FBI;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>In an answer to a question on the Board’s application form; or</text> </paragraph> <paragraph num="(c)"> <text>From any other source; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) this regulation is incomplete or insufficient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to:</text> <paragraph num="(1)"> <text>Complete the application; and</text> </paragraph> <paragraph num="(2)"> <text>Provide all information and documents required in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board in §A of this regulation within 12 months from the date the application is received by the Board, then the application:</text> <paragraph num="(1)"> <text>Shall be considered abandoned; and</text> </paragraph> <paragraph num="(2)"> <text>May be destroyed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Once an application is deemed abandoned under §C of this regulation, an individual seeking licensure shall:</text> <paragraph num="(1)"> <text>Submit a new application;</text> </paragraph> <paragraph num="(2)"> <text>Meet all of the requirements for licensure; and</text> </paragraph> <paragraph num="(3)"> <text>Pay the required fees that are in effect at the time of re-application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications of Applicants for Examination."> <paragraph num="A."> <text>An applicant for the registered nurse licensure examination shall:</text> <paragraph num="(1)"> <text>Complete satisfactorily and meet all requirements for a diploma or degree from an entry-level registered nursing education program approved by the Board</text> </paragraph> <paragraph num="(2)"> <text>Have a diploma or degree from an entry-level registered nursing education program in another state, territory, or country determined by the Board to be substantially equivalent to the registered nursing education program approved in this State at the time of the applicant's graduation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for the licensed practical nurse licensure examination shall:</text> <paragraph num="(1)"> <text>Meet all requirements for a high school diploma or its equivalent and complete satisfactorily and meet all requirements for a diploma from:</text> <paragraph num="(a)"> <text>A licensed practical nursing education program approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>A licensed practical nursing education program in any other state, territory, or country determined by the Board to be substantially equivalent to the licensed practical nursing education programs approved in this State at the time of the applicant's graduation; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Applicants for registered nurse licensure and licensed practical nurse licensure who take an English proficiency examination approved by the U.S. Department of Health and Human Services in order to demonstrate English language proficiency under Health Occupations Article, § 8-302(e), Annotated Code of Maryland, shall obtain the minimum passing scores for registered nurses and licensed practical nurses set by the Health Resources and Services Administration of the U.S. Department of Health and Human Services.</text> </paragraph> <paragraph num="D."> <text>An applicant whose entry-level registered nursing education program or licensed practical nursing education program was completed in another country shall have the applicant's transcript evaluated by the Commission on Graduates of Foreign Nursing Schools or a successor organization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Licensure by Examination."> <paragraph num="A."> <text>An applicant shall:</text> <paragraph num="(1)"> <text>Comply with all of the requirements in Regulation .04A of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>File and submit a completed application to the National Council of State Boards of Nursing on the form required; and</text> </paragraph> <paragraph num="(3)"> <text>Pay any required fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each application shall be signed by the nurse administrator of the school or program or an officer of the school to whom this responsibility has been designated.</text> </paragraph> <paragraph num="C."> <text>Applications may be signed before graduation and it shall be the responsibility of the person signing the application to submit written verification of program completion before the licensure examination.</text> </paragraph> <paragraph num="D."> <text>Applicants whose applications are complete and who, for any reason, fail to take the examination within 6 months shall be required to reapply and pay all fees.</text> </paragraph> <paragraph num="E."> <text>The authorization to test card shall be valid for a period of 6 months. If the applicant fails to complete the examination within that time frame the applicant is required to re-register and pay the NCLEX testing fee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Examination Procedures."> <paragraph num="A."> <text>Examinations shall be held at least once per year.</text> </paragraph> <paragraph num="B."> <text>The Board will participate with the National Council of State Boards of Nursing, Inc., in preparing and administering the National Council Licensure Examination for registered nurse and practical nurse licensure.</text> </paragraph> <paragraph num="C."> <text>The results of the NCLEX shall be reported as pass or fail.</text> </paragraph> <paragraph num="D."> <text>An authorization to test card shall be sent to each candidate that the Board determines to be eligible for the examination.</text> </paragraph> <paragraph num="E."> <text>Examination scores shall be released only to the candidate and to the school of nursing from which the candidate graduated, except on written authorization of the candidate.</text> </paragraph> <paragraph num="F."> <text>Candidates for Maryland licensure may write the licensure examination in any jurisdiction.</text> </paragraph> <paragraph num="G."> <text>Candidates applying for licensure in other jurisdictions may write the licensure examination in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Applicants Requiring Special Accommodation."> <paragraph num="A."> <text>An applicant with a disability may request modifications in examination materials or procedures. The applicant shall:</text> <paragraph num="(1)"> <text>Make the request for modifications in writing;</text> </paragraph> <paragraph num="(2)"> <text>Include in the request the following:</text> <paragraph num="(a)"> <text>The candidate's name;</text> </paragraph> <paragraph num="(b)"> <text>The date of the examination to be modified;</text> </paragraph> <paragraph num="(c)"> <text>A letter from the appropriate medical professional which:</text> <paragraph num="(i)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(ii)"> <text>Provides information describing the accommodations required; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A letter from the candidate's education program, indicating what modifications, if any, were granted by the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Requests for modification and supporting documentation shall be received by the application deadline.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Speech-Impaired Applicants."> <paragraph num="A."> <text>An applicant who claims a speech impairment shall fulfill all requirements for application, and shall submit to the Board documentation of the applicant's impairment, from:</text> <paragraph num="(1)"> <text>An otolaryngologist who has current certification from the American Board of Otolaryngology; and</text> </paragraph> <paragraph num="(2)"> <text>A speech-language pathologist who has current certification from the American Speech-Language-Hearing Association.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall require a speech-impaired applicant to prove the applicant's ability to communicate adequately with patients and other health care professionals by:</text> <paragraph num="(1)"> <text>Submitting letters from instructors in a nursing program, attesting to the applicant's ability to communicate in a professionally competent manner; and</text> </paragraph> <paragraph num="(2)"> <text>Meeting with the Board to demonstrate the manner in which communication with patients will occur.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A speech-language pathologist or otolaryngologist may be asked to attend the meeting in an advisory capacity to the Board to aid in assessing an applicant's ability to communicate.</text> </paragraph> <paragraph num="D."> <text>A foreign-educated, speech-impaired applicant shall notify the Board before taking a Board-approved standardized test for competency in the English language.</text> </paragraph> <paragraph num="E."> <text>The Board shall attempt to locate a speech-language pathologist fluent in the applicant's native language to assess the impairment.</text> </paragraph> <paragraph num="F."> <text>A foreign-educated applicant who is in need of foreign accent reduction, but who has competency in the applicant’s native language, may obtain assistance from a bilingual speech-language pathologist before attempting to pass a test for competency in the English language.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Licensure by Endorsement."> <paragraph num="A."> <text>An applicant who holds an active, unencumbered license to practice registered nursing or practical nursing in another state, territory, or country is eligible for licensure without examination if the applicant:</text> <paragraph num="(1)"> <text>Complies with all of the requirements under Regulation .04A of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Pays the required fee;</text> </paragraph> <paragraph num="(3)"> <text>Meets one of the conditions in §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Presents evidence of 1,000 hours of active nursing practice within the last 5 years or successful completion of a Board-approved refresher course or preceptor program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for licensure as a registered nurse by endorsement shall either:</text> <paragraph num="(1)"> <text>Hold a valid, unencumbered multistate license under the Nurse Licensure Compact; or</text> </paragraph> <paragraph num="(2)"> <text>Submit the following evidence directly to the Board from the appropriate authority:</text> <paragraph num="(a)"> <text>Verification that, at the time that applicant graduated from the nursing education program, the nursing education program was:</text> <paragraph num="(i)"> <text>Approved as a registered nursing or licensed practical nursing education program in that state, territory, or country; and</text> </paragraph> <paragraph num="(ii)"> <text>Substantially equivalent to the education program approved in this State;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Verification that the applicant passed one of the following licensure examinations under the laws of another state, territory, or country:</text> <paragraph num="(i)"> <text>If completed from 1952 to 1982, the “State Board Test Pool Examination — Registered Nurse or Practical Nurse”;</text> </paragraph> <paragraph num="(ii)"> <text>If completed from 1982 to present, the “National Council Licensure Examination — Registered Nurse or Practical Nurse”;</text> </paragraph> <paragraph num="(iii)"> <text>If completed before, 1952, the “National League for Nursing State-Constructed Board Examination, Registered Nurse or Practical Nurse”; or</text> </paragraph> <paragraph num="(iv)"> <text>If completed before 1982, “Canadian Nurses Association Test Service Examination for Registered Nurses”;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For applicants whose entry-level registered nursing education program or licensed practical nursing education program was completed in another country, a copy of an evaluation of the applicant's transcript by the Commission on Graduates of Foreign Nursing Schools or successor organization; and</text> </paragraph> <paragraph num="(d)"> <text>Except as provided in §D(1) of this regulation, proof of written and oral competency in the English language, in accordance with Health Occupations Article, § 8-302(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for licensure as a registered nurse by endorsement who cannot provide the evidence required under §B(2) of this regulation may qualify for licensure if the applicant submits evidence, as required by the Board, that the applicant has:</text> <paragraph num="(1)"> <text>Completed satisfactorily and met all requirements for an associate or a baccalaureate degree in registered nursing from a college or university that, at the time of the applicant’s graduation, is:</text> <paragraph num="(a)"> <text>Accredited by a national or regional nursing accreditation agency that is recognized by the Secretary of the U.S. Department of Education or the Council for Higher Education Accreditation; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the board of nursing or other applicable state regulator in the state in which the program is located; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 1,000 hours of practice in direct patient care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>English Language Competency Requirements for Endorsement.</text> <paragraph num="(1)"> <text>An applicant is not required to submit proof of English language competency if the applicant demonstrates that the applicant holds or has held a license to practice registered nursing or licensed practical nursing in another state if that state has an English language competency component for licensure or examination.</text> </paragraph> <paragraph num="(2)"> <text>Applicants for registered nurse licensure and licensed practical nurse licensure who take an English proficiency examination approved by the U.S. Department of Health and Human Services in order to demonstrate English language proficiency under Health Occupations Article, § 8-302(e), Annotated Code of Maryland, shall obtain the minimum passing scores for registered nurses and licensed practical nurses set by the Health Resources and Services Administration of the U.S. Department of Health and Human Services.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Those applicants who cannot present evidence of 1,000 hours of active nursing practice within the last 5 years, or successful completion of a Board-approved refresher course or preceptor program, may apply for inactive license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Issuance of Licenses."> <paragraph num="A."> <text>An initial license shall be issued to each applicant passing the licensure examination or qualifying for licensure by endorsement provided that:</text> <paragraph num="(1)"> <text>The applicant meets all the requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The Board has:</text> <paragraph num="(a)"> <text>Received and reviewed the criminal history record information; and</text> </paragraph> <paragraph num="(b)"> <text>Approved the application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An initial license may not be issued for less than 90 days.</text> </paragraph> <paragraph num="C."> <text>An incorrect license issued as a result of a Board error will be corrected in the Board’s data base at no charge to the licensee.</text> </paragraph> <paragraph num="D."> <text>A licensee who requests a change of name for a license shall:</text> <paragraph num="(1)"> <text>Make the request in writing on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Provide appropriate legal documentation supporting the change.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Temporary Licensure."> <paragraph num="A."> <text>The Board may issue a temporary license to an applicant who passed the licensure examination and is waiting for the criminal history records check to be completed or who is licensed as a registered nurse or licensed practical nurse in any other state provided that the applicant:</text> <paragraph num="(1)"> <text>Completes the required application;</text> </paragraph> <paragraph num="(2)"> <text>If licensed in another state, presents a copy of a current, active license in another state;</text> </paragraph> <paragraph num="(3)"> <text>Presents positive personal identification;</text> </paragraph> <paragraph num="(4)"> <text>Pays the required fee; and</text> </paragraph> <paragraph num="(5)"> <text>Provides written, verified evidence that the applicant has submitted to a criminal history records check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided in §§C and E of this regulation, temporary licenses expire 90 days after date of issuance and are not renewable.</text> </paragraph> <paragraph num="C."> <text>A temporary license may be extended for an additional 90 days if the applicant is waiting for the completion of the criminal history record information.</text> </paragraph> <paragraph num="D."> <text>The Board shall revoke a temporary license if the criminal history records check reveals that the applicant has been convicted of or pled guilty or nolo contendere to an act that would be cause for discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>If an applicant does not meet the practice requirement in Regulation .10A(5) of this chapter, a temporary license may be extended every 90 days:</text> <paragraph num="(1)"> <text>Pending completion of the practice requirement; and</text> </paragraph> <paragraph num="(2)"> <text>Provided that the total length of the temporary license does not exceed 12 months from the original date of issuance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Renewal of License."> <paragraph num="A."> <text>The Board shall renew the license of a licensee who meets all the requirements of Health Occupations Article, §8-312, Annotated Code of Maryland and of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Board shall renew licenses biennially according to the following schedule:</text> <paragraph num="(1)"> <text>A registered nurse or licensed practical nurse with an odd-numbered birth year shall always renew in an odd-numbered year not later than the 28th day of the licensee’s birth month; and</text> </paragraph> <paragraph num="(2)"> <text>A registered nurse or licensed practical nurse with an even-numbered birth year shall always renew in an even-numbered year not later than the 28th day of the licensee’s birth month.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least 3 months before a license expires, the Board shall send the licensee a renewal notice by:</text> <paragraph num="(1)"> <text>First-class mail to the last known address of the licensee; or</text> </paragraph> <paragraph num="(2)"> <text>Electronic means to the last known electronic address of the licensee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>It shall be the responsibility of the licensee to notify the Board if a renewal notice is not received.</text> </paragraph> <paragraph num="E."> <text>The Board cannot guarantee that renewal applications received later than 30 days before the expiration date will be processed before the expiration date.</text> </paragraph> <paragraph num="F."> <text>The Board shall issue a volunteer license to any registered nurse or licensed practical nurse who meets the licensure renewal requirements provided the licensee:</text> <paragraph num="(1)"> <text>Certifies to the Board that the licensee provides professional services only as a volunteer;</text> </paragraph> <paragraph num="(2)"> <text>Completes the required application; and</text> </paragraph> <paragraph num="(3)"> <text>Pays the required fee.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Active Licensure Renewal.</text> <paragraph num="(1)"> <text>An individual applying for active licensure renewal shall show evidence of:</text> <paragraph num="(a)"> <text>1,000 hours of active nursing practice within the 5 years immediately preceding the date of the renewal application;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory completion of all requirements for a diploma or degree from a Board-approved nursing education program within the 5 years immediately preceding the date of the renewal application; or</text> </paragraph> <paragraph num="(c)"> <text>Completion of 30 continuing education units (CEUs) within the 2 years immediately preceding the date of the renewal application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>College or University Coursework.</text> <paragraph num="(a)"> <text>A renewal applicant may submit qualifying college or university coursework to fulfill the requirement under §G(1)(c) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>15 CEUs shall be awarded for each semester hour completed of a qualifying college or university course.</text> </paragraph> <paragraph num="(c)"> <text>For the coursework to qualify:</text> <paragraph num="(i)"> <text>The college or university course shall be related to the renewal applicant’s nursing practice; and</text> </paragraph> <paragraph num="(ii)"> <text>The renewal applicant shall receive a grade of C or higher, or the numeric equivalent in the course.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>An official transcript shall be acceptable as proof of completion of a qualifying college or university course.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>Except as provided in §G(2) of this regulation, CEUs shall be approved by an entity listed in §H(5) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>CEUs used for the purpose of renewing a license are subject to random audits by the Board or the Board’s designee.</text> </paragraph> <paragraph num="(3)"> <text>CEUs that are used for the purpose of renewing a license shall be earned within the 2 years immediately preceding the date of the renewal application.</text> </paragraph> <paragraph num="(4)"> <text>The renewal applicant shall be responsible for:</text> <paragraph num="(a)"> <text>Ensuring that a CEU course, forum, or meeting has been approved for CEUs by one of the entities listed in §H(5) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Retaining evidence of completed CEUs that are submitted for the purpose of renewing a license for 6 years after the license is renewed; and</text> </paragraph> <paragraph num="(c)"> <text>Producing evidence of completed CEUs for an audit by the Board or the board’s designee within 30 days of the request.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Board shall accept CEUs awarded or approved by:</text> <paragraph num="(a)"> <text>Area Health Education Centers (AHEC), including all local, state, and national centers;</text> </paragraph> <paragraph num="(b)"> <text>The American Nurses Association (ANA);</text> </paragraph> <paragraph num="(c)"> <text>The American Nurses Credentialing Center (ANCC);</text> </paragraph> <paragraph num="(d)"> <text>Professional organizations offering CEUs for the purpose of renewing a national certification for advanced practice registered nursing;</text> </paragraph> <paragraph num="(e)"> <text>A local, state, or national professional nursing association that provides educational programs;</text> </paragraph> <paragraph num="(f)"> <text>The Maryland Nurses Association (MNA);</text> </paragraph> <paragraph num="(g)"> <text>The National Council of State Boards of Nursing; and</text> </paragraph> <paragraph num="(h)"> <text>The National League for Nursing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>CEUs may not be carried forward into the next renewal period.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An individual applying for active licensure renewal who do not meet the requirements of §G of this regulation shall be required to successfully complete a Board-approved refresher program or Board-approved preceptorship program prior to renewal of the license.</text> </paragraph> <paragraph num="J."> <text>Tax Deficiencies.</text> <paragraph num="(1)"> <text>On a monthly basis, the Board shall notify the Office of the Comptroller of any licensee or certificate-holder:</text> <paragraph num="(a)"> <text>Whose license expires within the next 4-month period; and</text> </paragraph> <paragraph num="(b)"> <text>Whose identity has not previously been provided to the Office of the Comptroller.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon notification by the Office of the Comptroller of any licensee or certificate-holder who is delinquent in the payment of undisputed taxes or unemployment insurance contributions, the Board shall notify the licensee or certificate-holder that renewal processing shall be delayed until the Office of the Comptroller verifies that the licensee or certificate-holder has made arrangements for payment of the undisputed taxes or unemployment insurance contributions that are satisfactory to the unit responsible for collection.</text> </paragraph> <paragraph num="(3)"> <text>Upon notification by the Office of the Comptroller that the licensee or certificate-holder has made satisfactory arrangements for payment of the undisputed taxes or unemployment insurance contributions, and where the licensee or certificate-holder is otherwise qualified for licensure, the Board shall renew the license or certificate.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Along with the renewal notice in accordance with §C of this regulation, the Board shall:</text> <paragraph num="(1)"> <text>Notify every renewal applicant who is required to have a criminal history records check in the selected birth month; and</text> </paragraph> <paragraph num="(2)"> <text>Send the renewal applicant instructions for downloading and completing the documents needed to submit to a criminal history records check.</text> </paragraph> </paragraph> <paragraph num="L."> <text>If a renewal applicant is out of the state, the Board shall mail a packet to the applicant with the required documents and instructions for completing the documents.</text> </paragraph> <paragraph num="M."> <text>Upon notification by the Board that a criminal history records check is required before a license can be renewed, a renewal applicant shall comply with all of the requirements under Regulation .04A of this chapter.</text> </paragraph> <paragraph num="N."> <text>Criminal history record checks for renewal applicants shall be scheduled according to the licensee's birth month as follows:</text> <paragraph num="(1)"> <text>In 2025 — all applicants with an August or September birth month;</text> </paragraph> <paragraph num="(2)"> <text>In 2026 — all applicants with a September or October birth month;</text> </paragraph> <paragraph num="(3)"> <text>In 2027 — all applicants with an October or November birth month;</text> </paragraph> <paragraph num="(4)"> <text>In 2028 — all applicants with a November or December birth month;</text> </paragraph> <paragraph num="(5)"> <text>In 2029 — all applicants with a December or January birth month;</text> </paragraph> <paragraph num="(6)"> <text>In 2030 — all applicants with a January or February birth month;</text> </paragraph> <paragraph num="(7)"> <text>In 2031 — all applicants with a February or March birth month;</text> </paragraph> <paragraph num="(8)"> <text>In 2032 — all applicants with a March or April birth month;</text> </paragraph> <paragraph num="(9)"> <text>In 2033 — all applicants with an April or May birth month;</text> </paragraph> <paragraph num="(10)"> <text>In 2034 — all applicants with a May or June birth month;</text> </paragraph> <paragraph num="(11)"> <text>In 2035 — all applicants with a June or July birth month; and</text> </paragraph> <paragraph num="(12)"> <text>In 2036 — all applicants with a July or August birth month.</text> </paragraph> </paragraph> <paragraph num="O."> <text>For renewal applicants who are required to submit to a criminal history records check, the Board may not renew a license without written documentation that the applicant has submitted to a criminal history record check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place the license of any registered nurse or licensed practical nurse on inactive status if the licensee:</text> <paragraph num="(1)"> <text>Has not satisfactorily completed 1,000 hours of active nursing practice or graduated from an approved nursing program within the 5-year period immediately preceding the date of anticipated renewal or chooses inactive status;</text> </paragraph> <paragraph num="(2)"> <text>Completes the biennial application for inactive status; and</text> </paragraph> <paragraph num="(3)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee on inactive status may not practice nursing in this State. However, a registered nurse on inactive status may use the title “registered nurse”, and a practical nurse on inactive status may use the title “licensed practical nurse”.</text> </paragraph> <paragraph num="C."> <text>A licensee on inactive status may apply for an active status license provided that the licensee:</text> <paragraph num="(1)"> <text>Meets the renewal requirements of Health Occupations Article, §8-312, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>The required application; and</text> </paragraph> <paragraph num="(b)"> <text>Written, verified evidence that the licensee has submitted to a criminal history records check in accordance with Regulation .13 of this chapter by:</text> <paragraph num="(i)"> <text>Submitting two sets of fingerprints required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(ii)"> <text>Paying all fees required by the Central Repository and the FBI.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An additional fee may not be charged to change from inactive to active status.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Expiration of License."> <paragraph num="A."> <text>A license expires on the 28th day of the licensee's birth month.</text> </paragraph> <paragraph num="B."> <text>A licensee has a 30-day grace period beyond the expiration date of a license to renew a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Refresher Course and Preceptorship Requirements."> <paragraph num="A."> <text>Refresher courses and preceptor programs, as defined in Regulation .01B of this chapter, shall be approved by the Board before their implementation and at least every 5 years after that.</text> </paragraph> <paragraph num="B."> <text>The registered nurse curriculum shall:</text> <paragraph num="(1)"> <text>Have a minimum of 80 theory hours, 60 clinical hours, and 8 hours of a classroom laboratory training before the on-site clinical experience;</text> </paragraph> <paragraph num="(2)"> <text>Include the following content areas:</text> <paragraph num="(a)"> <text>The nursing process;</text> </paragraph> <paragraph num="(b)"> <text>Management and delegation of patient care;</text> </paragraph> <paragraph num="(c)"> <text>Documentation and information management;</text> </paragraph> <paragraph num="(d)"> <text>Pharmacology, including calculation;</text> </paragraph> <paragraph num="(e)"> <text>Nursing care of patients with alterations in body systems;</text> </paragraph> <paragraph num="(f)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(g)"> <text>Disaster response; and</text> </paragraph> <paragraph num="(h)"> <text>Professional responsibilities, which include, but are not limited to, the following:</text> <paragraph num="(i)"> <text>Trends in nursing and the health care system;</text> </paragraph> <paragraph num="(ii)"> <text>Legal aspects of nursing; and</text> </paragraph> <paragraph num="(iii)"> <text>Development and initiation of patient and community health education.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The practical nurse curriculum shall:</text> <paragraph num="(1)"> <text>Have a minimum of 60 theory hours, 60 on-site clinical hours, and 8 hours of a classroom laboratory training before the on-site clinical experience;</text> </paragraph> <paragraph num="(2)"> <text>Include the following content areas:</text> <paragraph num="(a)"> <text>The nursing process with the licensed practical nurse as a contributor;</text> </paragraph> <paragraph num="(b)"> <text>Provision and delegation of patient care under the supervision of a registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>Documentation and information management;</text> </paragraph> <paragraph num="(d)"> <text>Pharmacology, including calculations;</text> </paragraph> <paragraph num="(e)"> <text>Nursing care of patients with common health problems;</text> </paragraph> <paragraph num="(f)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(g)"> <text>Disaster response; and</text> </paragraph> <paragraph num="(h)"> <text>Professional responsibilities, which include, but are not limited to, the following:</text> <paragraph num="(i)"> <text>Trends in nursing;</text> </paragraph> <paragraph num="(ii)"> <text>Legal aspects of nursing; and</text> </paragraph> <paragraph num="(iii)"> <text>Contribution to patient health teaching.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The organization and utilization of curriculum materials shall be based on accepted educational principles.</text> </paragraph> <paragraph num="E."> <text>Faculty Qualifications.</text> <paragraph num="(1)"> <text>Faculty shall:</text> <paragraph num="(a)"> <text>Be a registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Have a baccalaureate degree in nursing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A minimum of 3 years of clinical and teaching experience is recommended.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Faculty shall:</text> <paragraph num="(1)"> <text>Plan, implement, evaluate, and revise the educational program.</text> </paragraph> <paragraph num="(2)"> <text>Select and evaluate clinical facilities used to achieve program objectives.</text> </paragraph> <paragraph num="(3)"> <text>Develop and utilize:</text> <paragraph num="(a)"> <text>Written examinations to measure achievement of program objectives.</text> </paragraph> <paragraph num="(b)"> <text>An evaluation tool to measure achievement of clinical competencies. The clinical competencies shall be based upon the registered nurse and licensed practical nurse standards of practice.</text> </paragraph> <paragraph num="(c)"> <text>A mechanism for student evaluation of the course.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Students shall complete theoretical instruction either before or concurrent with clinical instruction.</text> </paragraph> <paragraph num="H."> <text>All program requirements including required clinical hours shall be completed within 12 months of the starting date of the refresher course.</text> </paragraph> <paragraph num="I."> <text>Clinical facilities shall provide sufficient opportunities to meet the learning objectives of the refresher course.</text> </paragraph> <paragraph num="J."> <text>The faculty/student ratio may not exceed 1:10 in the clinical area.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate the license of a former licensee who has failed to renew the license for any reason if the former licensee meets the renewal requirements.</text> </paragraph> <paragraph num="B."> <text>After January 1, 2010, an applicant for reinstatement who has failed to renew the applicant's license for a period of 1 year or more shall submit to a criminal history records check before the license is reinstated.</text> </paragraph> <paragraph num="C."> <text>Temporary License.</text> <paragraph num="(1)"> <text>The Board shall issue a temporary license to a former licensee who:</text> <paragraph num="(a)"> <text>Applies for reinstatement in accordance with Health Occupations Article, §8-313, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Meets the renewal requirements of Health Occupations Article, §8-312, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Is awaiting the completion of the criminal history records check.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The temporary license issued pursuant to §C(1) of this regulation is effective until the earlier of 90 days after the date of issue or the date the Board issues an active license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Violation of Regulations."> <paragraph num="A."> <text>If a program is thought to be in violation of this chapter, the following steps shall be taken:</text> <paragraph num="(1)"> <text>The Board shall notify the program of the regulations it is violating;</text> </paragraph> <paragraph num="(2)"> <text>The program shall submit a plan with a proposed time frame for correcting the violations;</text> </paragraph> <paragraph num="(3)"> <text>The plan shall be due within 30 days of receipt of notification of the violations;</text> </paragraph> <paragraph num="(4)"> <text>The Board's professional staff may, at the request of the Board, visit the program;</text> </paragraph> <paragraph num="(5)"> <text>After receipt of the plan, the Board shall provide the program with a reasonable time frame within which to correct the violations; and</text> </paragraph> <paragraph num="(6)"> <text>Upon expiration of the time period for correcting violations, a member of the Board's staff shall visit the program to determine if the school is in compliance with the regulations, and report to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the program does not correct the violations within the time frame established by the Board, the Board:</text> <paragraph num="(1)"> <text>Shall notify the program that it has not corrected violations in a reasonable time and schedule a hearing in accordance with the Administrative Procedure Act; and</text> </paragraph> <paragraph num="(2)"> <text>If, after a hearing, determines that the program or preceptorship is in violation of the regulations, may place a program on either conditional approval or remove it from the approved list of programs. If the Board places the program on conditional approval, the Board may request that a program suspend admission of students. A program placed on conditional approval shall remain in that status until the Board determines it has complied with the regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless authorized to practice as a nursing graduate under this chapter, an individual may not use the words “nursing graduate”, the abbreviation “NG”, or any other title, symbol, abbreviation, sign, card, device, or other representation with the intent to represent that the individual practices as a nursing graduate.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1–230, 8-101, 8-201, 8-205, 8-206, 8-301—8-315, 8-6A-05(a), 8-701, 8-7A-01, Article 1116(b)(2), and 8-703; Tax-General Article, §§10-738 and 10-739(b)(1); Annotated Code of Maryland; Ch. 486, Acts of 2012; Chs. 281 and 282, Acts of 2013; Chs. 385 and 386, Acts of 2016; and Chs. 234 and 234, Acts of 2017</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B, C amended effective May 5, 1978 (5:9 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 7, 1976 (3:1 Md. R. 40)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, F amended effective October 13, 1976 (13:21 Md. R. 1206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended effective May 14, 1975 (2:10 Md. R. 752)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 7, 1976 (3:1 Md. R. 40)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 renumbered as Regulations .02, .03, .04, .05, .07, .08, and .09, respectively</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, C, E, G, H amended effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective June 29, 1979 (6:13 Md. R. 1128)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03A—F, H and .05A amended effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08A, C and .09 amended effective March 23, 1979 (6:6 Md. R. 512)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective April 11, 1994 (21:9 Md. R. 744); amended permanently effective August 15, 1994 (21:16 Md. R. 1384)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 11, 1989 (16:24 Md. R. 2620); May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective December 11, 1989 (16:24 Md. R. 2620); October 1, 1990 (17:19 Md. R. 2321); May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective July 1, 1991 (18:14 Md. R. 1606); adopted permanently effective January 2, 1992 (18:25 Md. R. 2751)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective October 27, 1995 (22:23 Md. R. 1795); amended permanently effective February 12, 1996 (23:3 Md. R. 169)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective November 14, 1997 (24:25 Md. R. 1717); amended permanently effective March 9, 1998 (25:5 Md. R. 369)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective August 2, 1999 (26:17 Md. R. 1314); amended permanently effective November 15, 1999 (26:23 Md. R. 1777)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective November 8, 1993 (20:22 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended as an emergency provision effective November 1, 1987 (14:23 Md. R. 2412); adopted permanently effective March 1, 1988 (15:3 Md. R. 304)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 1, 1990 (17:19 Md. R. 2321); May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective December 11, 1989 (16:24 Md. R. 2620); November 8, 1993 (20:22 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E adopted effective October 1, 1990 (17:19 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective October 27, 1995 (22:23 Md. R. 1795); amended permanently effective February 12, 1996 (23:3 Md. R. 169)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 11, 1989 (16:24 Md. R. 2620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D amended and H adopted effective October 1, 1990 (17:19 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10I adopted effective May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 recodified to Regulation .12 and new Regulation .11 adopted effective December 11, 1989 (16:24 Md. R. 2620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective December 11, 1989 (16:24 Md. R. 2620)</annotation> <annotation type="History" subtype="Administrative History">Regulations .14 and .15 adopted effective May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 30, 2001 (28:8 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 22, 2008 (35:19 Md. R. 1717)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C adopted effective September 22, 2008 (35:19 Md. R. 1717)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective April 1, 2013 (40:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective September 3, 2001 (28:17 Md. R. 1556); August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective September 22, 2008 (35:19 Md. R. 1717)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 22, 2008 (35:19 Md. R. 1717)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective September 3, 2001 (28:17 Md. R. 1556)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 1, 2004 (31:4 Md. R. 316); September 27, 2004 (31:19 Md. R. 1433)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective September 22, 2008 (35:19 Md. R. 1717)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 1, 2013 (40:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12F, G amended effective April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12H adopted effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12I, J, K adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12I amended effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12I-1, I-2, J-1 adopted effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12I-1 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13C amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 13, 2017 (44:3 Md. R. 189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); June 17, 2019 (46:12 Md. R. 544); August 23, 2021 (48:17 Md. R. 669); Regulation .01B amended as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); amended permanently effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 27, 2026 (53:8 Md. R. 356</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D adopted effective August 23, 2021 (48:17 Md. R. 669)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 29, 2018 (45:2 Md. R. 69); July 1, 2025 (52:10 Md. R. 436)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023; Regulation .03C amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); amended permanently effective October 13, 2025 (52:20 Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667); April 27, 2026 (53:8 Md. R. 356)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective August 23, 2021 (48:17 Md. R. 669)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended as an emergency provision effective October 6, 2023 (50:22 Md. R. 972); emergency status expired effective April 3, 2024</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective June 24, 2024 (51:12 Md. R. 619)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F repealed effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D, F amended effective July 2, 2018 (45:13 Md. RR. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective August 28, 2017 (44:17 Md. R. 835); July 2, 2018 (45:13 Md. R. 667); August 23, 2021 (48:17 Md. R. 669); April 27, 2026 (53:8 Md. R. 356)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective July 2, 2018 (45:13 Md. R. 667); June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13N amended as an emergency provision effective June 24, 2025 (52:15 Md. R. 810); amended permanently effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C adopted as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .17C adopted as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); adopted permanently effective October 13, 2025 (52:20 Md. R. 1001)</annotation> </annotations> </chapter> <chapter num="02" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations apply only to formal hearings before the Board based on charges or notices of proposed action issued pursuant to Health Occupations Article, §§8-316, 8-404, 8-6A-10, 8-6B-18, 8-6C-20 or 8–6D–10, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Notice of Hearing."> <paragraph num="A."> <text>The Board shall send written notice of the hearing to all interested parties at least 30 days before the hearing.</text> </paragraph> <paragraph num="B."> <text>The Board shall notify the parties of:</text> <paragraph num="(1)"> <text>The date, time, and place of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>A clear and concise statement of the facts asserted; and</text> </paragraph> <paragraph num="(3)"> <text>The charges alleged.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the facts cannot be stated in detail when the notice is given, the Board shall state the issues involved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-2" heading="Prehearing Conferences."> <text>The Board may set prehearing conferences as it considers appropriate.</text> </regulation> <regulation prefix="Regulation" num=".01-3" heading="Discovery."> <paragraph num="A."> <text>Discovery on Request. By written request served on other parties and filed with this Board, a party may require another party to produce, within 15 calendar days:</text> <paragraph num="(1)"> <text>A list of witnesses to be called; and</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party the name and curriculum vitae of any expert witness who will testify at the hearing not later than 15 days before the scheduled hearing date.</text> </paragraph> <paragraph num="(2)"> <text>The designation of an expert witness shall be accompanied by a detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> <paragraph num="(3)"> <text>If the Board finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board shall exclude from the hearing the testimony and any report of the expert.</text> </paragraph> <paragraph num="(4)"> <text>At the hearing, the Board shall consider arguments regarding the sufficiency of the report.</text> </paragraph> <paragraph num="(5)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, the report satisfies the requirements set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Ongoing Duty of Disclosure.</text> <paragraph num="(1)"> <text>All parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(2)"> <text>If witnesses or documents are later added to the list provided under §A of this regulation, each party shall provide notice of these witnesses or documents to the opposing party during business hours at least 1 day before the hearing.</text> </paragraph> <paragraph num="(3)"> <text>The notice requirement referred to in §D(2) of this regulation applies only to witnesses or documents to be used in the party's case-in-chief and not to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Representation."> <paragraph num="A."> <text>A party appearing at a formal hearing has the right to appear in proper person or by or with counsel. A party has the right to be accompanied, represented, and advised by counsel.</text> </paragraph> <paragraph num="B."> <text>Unless authorized to practice law in this State, a counsel may not represent a party before the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceeding, or part of a proceeding, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Presiding Officer Duties."> <text>A quorum of the Board shall be present for each formal hearing. The president, or the president's designee, is the presiding officer, and has complete charge of the hearing, permitting the examination of witnesses, admitting evidence, ruling on the admissibility of evidence, and adjourning or recessing the hearing from time to time.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Order of Procedure."> <text>The order in which the parties shall present their case shall be determined by the presiding officer.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Examination of Witnesses and Introduction of Evidence."> <paragraph num="A."> <text>The rules of evidence in all hearings under these bylaws are as set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions, and motions. However, when a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by the counsel.</text> </paragraph> <paragraph num="C."> <text>The presiding officer, or any person designated by the presiding officer for the purpose, may examine any witness called by any party. The presiding officer may call as a witness any person in attendance at the hearing. Any member of the Board may examine any witness called by any party.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Briefs."> <text>Any party may submit briefs of the issues of fact and law involved in the hearing. The briefs shall be filed in the form, with the number of copies, and at the time that the presiding officer designates.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Request for Office of the Attorney General Counsel."> <text>The Board may request the Office of the Attorney General to participate in any hearing as counsel for the Board. Upon that request, the counsel is entitled to submit evidence and question witnesses on behalf of the Board as permitted by State Government Article, §10-213, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Decision and Order."> <text>The Board shall render every decision and order in writing, which shall be accompanied by findings of fact and conclusions of law. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party's attorney of record.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1), and 8-317, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 30, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective November 23, 1981 (8:23 Md. R. 1857)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .01-1 recodified to .01-1 and .01-2, respectively, and Preface recodified to Regulation .01 Scope, July 1991</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 3, 1995 (22:13 Md. R. 967); March 14, 2005 (32:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 repealed and new Regulation .01-1 adopted effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-3 adopted effective April 30, 2001 (28:8 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 14, 2005 (32:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective July 3, 1995 (22:13 Md. R. 967)</annotation> </annotations> </chapter> <chapter num="03" heading="Nursing Education Programs"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approval” means the status granted to a nursing education program that:</text> <paragraph num="(a)"> <text>Is in compliance with the regulations of the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Holds a certificate of approval from the Board of Nursing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Articulation” means the process by which a registered nurse or licensed practical nurse who is enrolled in a nursing education program is given credit for previous nursing education.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Board-recognized nursing accreditation agency (BRNAA)” means a national or regional nursing education accreditation agency recognized by the:</text> <paragraph num="(a)"> <text>Secretary of the United States Department of Education (USDOE); and</text> </paragraph> <paragraph num="(b)"> <text>Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Clinical Learning Experience.</text> <paragraph num="(a)"> <text>“Clinical learning experience” means faculty planned and guided learning activities designed to assist students to meet the course objectives and apply nursing knowledge and skills in the direct care of patients.</text> </paragraph> <paragraph num="(b)"> <text>“Clinical learning experience” includes:</text> <paragraph num="(i)"> <text>Direct care of patients within the relevant practice setting;</text> </paragraph> <paragraph num="(ii)"> <text>Clinical support activities such as clinical conferences; and</text> </paragraph> <paragraph num="(iii)"> <text>Simulation laboratories.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Clinical nurse faculty” means an individual with at least a baccalaureate degree in nursing who is employed by the program solely for clinical learning of nursing students.</text> </paragraph> <paragraph num="(7)"> <text>“Clinical preceptor” means a registered nurse employee of a cooperating clinical agency acting to facilitate and supervise student learning in a manner specified in a signed written agreement between the cooperating clinical agency and the educational institution.</text> </paragraph> <paragraph num="(8)"> <text>“Clinical preceptorship” means an organized system of clinical experience that allows a nursing student to be paired with a clinical preceptor for the purpose of attaining specific learning objectives.</text> </paragraph> <paragraph num="(9)"> <text>“Conditional approval” means a limited-time status that:</text> <paragraph num="(a)"> <text>Is imposed by the Board if the Board finds evidence that the program has failed to meet or maintain the regulations or requirements, or both, set by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Allows the program to continue to operate subject to the program conforming to the Board’s requirements and recommendations within a time period set by the Board.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Controlling institution” means an organization that offers a nursing education program.</text> </paragraph> <paragraph num="(11)"> <text>“Cooperating clinical agency” means an agency that provides the facilities and clinical resources for clinical learning experiences in nursing, with the nurse faculty or the clinical nurse faculty of the program responsible for the planning, implementation, and evaluation of these experiences.</text> </paragraph> <paragraph num="(12)"> <text>“Curriculum changes” means changes in course offerings that will alter the curriculum, philosophy, objectives, outcomes, competencies, or conceptual framework of the program.</text> </paragraph> <paragraph num="(13)"> <text>“Full time nurse faculty equivalent” means nursing faculty who are designated as full time employees by their institution.</text> </paragraph> <paragraph num="(14)"> <text>“Generic student” means one who enters at the beginning of the nursing education program and plans to complete the entire curriculum.</text> </paragraph> <paragraph num="(15)"> <text>“Initial approval” means the approval period from the first admission of nursing students to the program through the first full implementation of the curriculum and graduation.</text> </paragraph> <paragraph num="(16)"> <text>“Informatics” means the use of technology in nursing practice.</text> </paragraph> <paragraph num="(17)"> <text>“Licensed practical nurse” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice licensed practical nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(19)"> <text>“MHEC” means Maryland Higher Education Commission.</text> </paragraph> <paragraph num="(20)"> <text>“Nurse faculty” means an individual with a graduate degree in nursing who is employed to teach full-time or part-time in a nursing education program.</text> </paragraph> <paragraph num="(21)"> <text>Program.</text> <paragraph num="(a)"> <text>“Program” means a registered nursing or licensed practical nursing educational program.</text> </paragraph> <paragraph num="(b)"> <text>“Program” includes any of the following:</text> <paragraph num="(i)"> <text>A college;</text> </paragraph> <paragraph num="(ii)"> <text>A school;</text> </paragraph> <paragraph num="(iii)"> <text>A division;</text> </paragraph> <paragraph num="(iv)"> <text>A department;</text> </paragraph> <paragraph num="(v)"> <text>An academic unit; or</text> </paragraph> <paragraph num="(vi)"> <text>A program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Regional nursing education accrediting agency” means an accrediting agency that operates in a specific geographic region of the United States and accredits post-secondary institutions and primary and secondary schools.</text> </paragraph> <paragraph num="(23)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Requirement” means a mandatory condition that a program meets:</text> <paragraph num="(a)"> <text>For the program to be approved; and</text> </paragraph> <paragraph num="(b)"> <text>To ensure that graduates of the program are eligible to take the NCLEX-RN® and NCLEX-PN®.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Simulation” means instructional activities and strategies that mimic the reality of a clinical environment and complement other clinical learning experiences.</text> </paragraph> <paragraph num="(26)"> <text>“Transfer student” means a student who is permitted to apply nursing courses completed at another institution to a nursing education program of study.</text> </paragraph> <paragraph num="(27)"> <text>“USDOE” means the United States Department of Education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Approval of Programs Accredited by a Board-Recognized Nursing Accreditation Agency."> <paragraph num="A."> <text>The Board shall place on its list of approved programs any nursing education program in Maryland granted accreditation by a BRNAA, provided the program meets all requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>A program approved by the Board and accredited by a BRNAA agency shall submit to the Board within 30 days of receipt:</text> <paragraph num="(1)"> <text>Evidence of current accreditation;</text> </paragraph> <paragraph num="(2)"> <text>Accreditation reports; and</text> </paragraph> <paragraph num="(3)"> <text>Any correspondence related to the status of the program's accreditation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall continue to grant approval to programs in Maryland filing evidence of continuing accreditation by the BRNAA, provided those programs continue to meet all requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board shall be notified in writing within 10 business days of any change in accreditation status by the nursing program.</text> </paragraph> <paragraph num="E."> <text>Withdrawal of accreditation, accreditation with warning, or failure to meet the requirements of this chapter or the standard for performance on the licensing examination shall be cause for Board review of the program in accordance with Regulations .16B and C and .17 of this chapter.</text> </paragraph> <paragraph num="F."> <text>A program on which the Board has taken action under Regulations .16B and C and .17 of this chapter shall be reported to MHEC.</text> </paragraph> <paragraph num="G."> <text>On a periodic basis, the Board shall compare its regulations to those of the BRNAA and the USDOE to ensure that the Board standards for programs are being met.</text> </paragraph> <paragraph num="H."> <text>The Board and MHEC shall inform one another in a timely manner of proposed changes to regulations that may affect nursing education programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Board Approval of Nonaccredited Programs."> <paragraph num="A."> <text>A Board-approved nursing education program that is not accredited by a BRNAA shall meet the requirements stated in Regulations .04—.16 of this chapter.</text> </paragraph> <paragraph num="B."> <text>In institutions having both a licensed practical nursing education program and a registered nursing education program and when only one of the programs is accredited by a BRNAA:</text> <paragraph num="(1)"> <text>Except as otherwise provided in Regulation .18 of this chapter, the Board and the BRNAA shall conduct concurrent visits; and</text> </paragraph> <paragraph num="(2)"> <text>The program shall submit an addendum to the accredited program's self-study describing the unique components of the nonaccredited program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A program on which the Board has taken action shall be reported to MHEC.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Philosophy and Objectives, Outcomes, or Competencies."> <paragraph num="A."> <text>The philosophy and program objectives, outcomes, or competencies shall be:</text> <paragraph num="(1)"> <text>Developed by the nursing faculty and represent a consensus of that faculty;</text> </paragraph> <paragraph num="(2)"> <text>Consistent with the characteristics of the specific type of nursing education program;</text> </paragraph> <paragraph num="(3)"> <text>Communicated to those responsible for and participating in the program; and</text> </paragraph> <paragraph num="(4)"> <text>Periodically evaluated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The philosophy of the program shall:</text> <paragraph num="(1)"> <text>Be consistent with that of the controlling institution and governing body;</text> </paragraph> <paragraph num="(2)"> <text>Articulate beliefs about individuals and their health, environment, nursing, adult education, and learning; and</text> </paragraph> <paragraph num="(3)"> <text>Serve as a foundation for developing, implementing, and evaluating the educational program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program objectives, outcomes, or competencies shall:</text> <paragraph num="(1)"> <text>Evolve from the philosophy of the program;</text> </paragraph> <paragraph num="(2)"> <text>Be clearly stated, measurable, and attainable;</text> </paragraph> <paragraph num="(3)"> <text>Serve as a foundation for planning, implementing, and evaluating the program; and</text> </paragraph> <paragraph num="(4)"> <text>Identify the expected competencies of the graduate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Administration and Organization."> <paragraph num="A."> <text>The controlling institution shall:</text> <paragraph num="(1)"> <text>Be accredited by the appropriate national or regional accrediting agency; and</text> </paragraph> <paragraph num="(2)"> <text>Have a statement of equal educational opportunity.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The organizational chart shall:</text> <paragraph num="(1)"> <text>Demonstrate the relationship of the nursing program to the controlling institution;</text> </paragraph> <paragraph num="(2)"> <text>Indicate lines of responsibility and authority; and</text> </paragraph> <paragraph num="(3)"> <text>Indicate channels of communication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program shall have comparable status with other academic units within the controlling institution.</text> </paragraph> <paragraph num="D."> <text>The controlling institution shall provide the financial support and resources needed to operate a program which:</text> <paragraph num="(1)"> <text>Meets the requirements of the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Fosters achievement of program goals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The financial resources shall support:</text> <paragraph num="(1)"> <text>Adequate educational facilities and equipment; and</text> </paragraph> <paragraph num="(2)"> <text>Qualified administrative, clerical, and instructional personnel.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The program shall be administered by a registered nurse who meets the qualifications stated in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="G."> <text>When the nursing program administrator changes, the administrative officer of the controlling institution shall submit written notification to the Board of the change indicating that the new program administrator meets the Board’s requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Reports."> <paragraph num="A."> <text>Accurate and appropriate records shall be maintained that include, but are not limited to:</text> <paragraph num="(1)"> <text>Current records of students;</text> </paragraph> <paragraph num="(2)"> <text>Transcripts of graduates;</text> </paragraph> <paragraph num="(3)"> <text>Faculty records;</text> </paragraph> <paragraph num="(4)"> <text>Administrative records, which include:</text> <paragraph num="(a)"> <text>Minutes of faculty meetings;</text> </paragraph> <paragraph num="(b)"> <text>Annual reports of the program; and</text> </paragraph> <paragraph num="(c)"> <text>School bulletins;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The current curriculum, including:</text> <paragraph num="(a)"> <text>Philosophy;</text> </paragraph> <paragraph num="(b)"> <text>Objectives or outcomes; and</text> </paragraph> <paragraph num="(c)"> <text>Course outlines;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Agreements with cooperating agencies; and</text> </paragraph> <paragraph num="(7)"> <text>A master plan of evaluation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Records shall be safely stored to prevent loss, destruction, or unauthorized use.</text> </paragraph> <paragraph num="C."> <text>The nursing program administrator shall submit an annual report to the Board on forms provided by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Nursing Program Administrator."> <paragraph num="A."> <text>Qualifications.</text> <paragraph num="(1)"> <text>Qualifications of the nursing program administrator include:</text> <paragraph num="(a)"> <text>Current licensure as a registered nurse in Maryland or possession of a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(b)"> <text>A graduate degree in nursing; and</text> </paragraph> <paragraph num="(c)"> <text>Academic preparation or experience in administration.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A doctorate in nursing or a related field is recommended for the nursing program administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Responsibilities. The nursing program administrator, with the participation of the faculty, is responsible for:</text> <paragraph num="(1)"> <text>Recommendations for faculty appointment and review;</text> </paragraph> <paragraph num="(2)"> <text>The educational program or programs;</text> </paragraph> <paragraph num="(3)"> <text>Preparing and administering the budget;</text> </paragraph> <paragraph num="(4)"> <text>Formulating and implementing policies pertinent to the program, which include but are not limited to:</text> <paragraph num="(a)"> <text>Admission and progression;</text> </paragraph> <paragraph num="(b)"> <text>Advanced standing;</text> </paragraph> <paragraph num="(c)"> <text>Transfer and articulation;</text> </paragraph> <paragraph num="(d)"> <text>Withdrawal;</text> </paragraph> <paragraph num="(e)"> <text>Reinstatement;</text> </paragraph> <paragraph num="(f)"> <text>Evaluation;</text> </paragraph> <paragraph num="(g)"> <text>Graduation requirements; and</text> </paragraph> <paragraph num="(h)"> <text>Competency in oral and written communication of the English language;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Determining the student/teacher ratio based on the objectives of the course, method of instruction used, and the requirements of the faculty;</text> </paragraph> <paragraph num="(6)"> <text>Determining the number of faculty, including clinical faculty, needed based on the:</text> <paragraph num="(a)"> <text>Number and academic level of enrolled students;</text> </paragraph> <paragraph num="(b)"> <text>Curriculum;</text> </paragraph> <paragraph num="(c)"> <text>Activities and responsibilities required of the faculty; and</text> </paragraph> <paragraph num="(d)"> <text>Number and geographic locations of the clinical facilities;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Developing, maintaining, complying with, and periodically reviewing written agreements with cooperating agencies;</text> </paragraph> <paragraph num="(8)"> <text>Implementing a faculty orientation and development program;</text> </paragraph> <paragraph num="(9)"> <text>Implementing the entire program in accordance with Board regulations;</text> </paragraph> <paragraph num="(10)"> <text>Assuring that all publications pertaining to the nursing program are clear, accurate, and current;</text> </paragraph> <paragraph num="(11)"> <text>Developing and implementing a written plan that provides that all students participating in clinical practice settings are physically and mentally competent at all times to provide safe client care; and</text> </paragraph> <paragraph num="(12)"> <text>Developing appropriate clinical learning experiences that reflect an understanding of the program's philosophy, objectives, outcomes or competencies, and curriculum.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Nurse Faculty and Clinical Nurse Faculty."> <paragraph num="A."> <text>Qualifications of Nurse Faculty.</text> <paragraph num="(1)"> <text>Nurse faculty shall:</text> <paragraph num="(a)"> <text>Be currently licensed as a registered nurse in Maryland or have a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(b)"> <text>Be academically and professionally qualified;</text> </paragraph> <paragraph num="(c)"> <text>Maintain expertise appropriate to their teaching responsibilities; and</text> </paragraph> <paragraph num="(d)"> <text>Have a minimum of 2 years of clinical experience as a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided under §B of this regulation, nurse faculty shall have a graduate degree in nursing.</text> </paragraph> <paragraph num="(3)"> <text>Non-nurse faculty, or nurses not meeting the requirements for nurse faculty, may teach selected portions of the nursing curriculum that relate to their areas of expertise.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Graduate Degree in Nursing Requirement for Nursing Faculty.</text> <paragraph num="(1)"> <text>A program experiencing a faculty shortage may petition the Board for a waiver of the graduate degree in nursing required by §A(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The petition for a waiver of the graduate degree in nursing shall include documentation that the institution has attempted to hire nurse faculty with graduate degrees and a summary of those efforts.</text> </paragraph> <paragraph num="(3)"> <text>The petition in §B(1) of this regulation shall include documentation verifying that the nurse faculty applicant for whom the waiver is requested has:</text> <paragraph num="(a)"> <text>A baccalaureate degree in nursing and a graduate degree in another field; or</text> </paragraph> <paragraph num="(b)"> <text>A baccalaureate degree in nursing and:</text> <paragraph num="(i)"> <text>Is enrolled as a student in an approved graduate study program in nursing; and</text> </paragraph> <paragraph num="(ii)"> <text>Will complete the graduate study program in nursing within 36 months.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the graduate degree in nursing is waived by the Board:</text> <paragraph num="(a)"> <text>The nurse faculty member for whom a waiver has been granted shall complete a minimum of 9 graduate credits in nursing within 24 months of the issuance of the waiver; and</text> </paragraph> <paragraph num="(b)"> <text>The program shall submit documentation to the Board of completion of the required credits by the nurse faculty member within 24 months of the date when the waiver was granted.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the nurse faculty member fails to complete the 9 graduate credits required in nursing within 24 months of the granting of the waiver, the Board may withdraw the waiver.</text> </paragraph> <paragraph num="(6)"> <text>If the waiver has been withdrawn, the program shall require that the nurse faculty member cease functioning as nurse faculty. If the program fails to do so, the Board may take action under Regulation .17 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>Once the nurse faculty member for whom the waiver was granted has met the 9 graduate credit waiver requirements, that nurse faculty member is considered to have met the educational requirements of §A(2) of this regulation.</text> </paragraph> <paragraph num="(8)"> <text>The Board shall grant a waiver for a nurse faculty member:</text> <paragraph num="(a)"> <text>With experience in teaching; and</text> </paragraph> <paragraph num="(b)"> <text>Who is within a semester of graduation with a graduate degree in nursing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Qualifications of Clinical Nurse Faculty.</text> <paragraph num="(1)"> <text>A clinical nurse faculty member shall:</text> <paragraph num="(a)"> <text>Be currently licensed as a registered nurse in Maryland or have a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(b)"> <text>Have a degree in nursing at or above the baccalaureate level;</text> </paragraph> <paragraph num="(c)"> <text>Have a minimum of 2 years of clinical experience as a registered nurse; and</text> </paragraph> <paragraph num="(d)"> <text>Have the clinical experience necessary to function effectively and safely in the clinical nurse faculty's area of responsibility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program may not, in any academic year, fill more than 25 percent of the program’s full-time nurse faculty equivalent positions with clinical nurse faculty whose highest nursing degree is at the baccalaureate level.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Responsibilities of Nurse Faculty and Clinical Nurse Faculty.</text> <paragraph num="(1)"> <text>Responsibilities of the nurse faculty include participation in the planning, implementation, evaluation, and revision of the educational program.</text> </paragraph> <paragraph num="(2)"> <text>Nurse faculty shall:</text> <paragraph num="(a)"> <text>Develop and implement standards for admission, progression, and graduation of students;</text> </paragraph> <paragraph num="(b)"> <text>Participate in academic advisement and guidance of students;</text> </paragraph> <paragraph num="(c)"> <text>Evaluate student performance;</text> </paragraph> <paragraph num="(d)"> <text>Maintain clinical skills in the nurse faculty’s area of responsibility;</text> </paragraph> <paragraph num="(e)"> <text>Develop and implement a plan to assure that all instructional materials are accessible, current, and relevant to the curriculum;</text> </paragraph> <paragraph num="(f)"> <text>Participate in the recruitment, selection, and promotion of nurse faculty and the recruitment and selection of clinical nurse faculty;</text> </paragraph> <paragraph num="(g)"> <text>Participate in peer evaluation of nurse faculty and clinical nurse faculty performance; and</text> </paragraph> <paragraph num="(h)"> <text>Elicit student evaluation of teaching effectiveness.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Clinical nurse faculty shall:</text> <paragraph num="(a)"> <text>Provide clinical instruction and supervision of students; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate student performance in clinical learning experiences.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Faculty Policies."> <paragraph num="A."> <text>There shall be written personnel policies for nurse faculty and clinical nurse faculty that conform to accepted educational standards.</text> </paragraph> <paragraph num="B."> <text>Policies concerning the teaching load for faculty and the nursing program administrator shall be in writing. Sufficient time shall be provided for faculty to accomplish those activities related to the teaching-learning process. If the program administrator is required to teach, the program administrator shall carry only a minimum teaching load.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Faculty Organization."> <paragraph num="A."> <text>The faculty shall be organized with written policies and procedures to guide its activities.</text> </paragraph> <paragraph num="B."> <text>The faculty shall meet regularly and function in such a manner that all members participate in planning, implementing, and evaluating the nursing program.</text> </paragraph> <paragraph num="C."> <text>Committees necessary to carry out the functions of the program shall be established with the duties and membership of each committee clearly defined.</text> </paragraph> <paragraph num="D."> <text>As appropriate, students shall participate on faculty committees.</text> </paragraph> <paragraph num="E."> <text>Minutes of faculty organization and committee meetings shall:</text> <paragraph num="(1)"> <text>Document actions and decisions of the faculty; and</text> </paragraph> <paragraph num="(2)"> <text>Be available for reference.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Faculty Development and Evaluation."> <paragraph num="A."> <text>There shall be a formal plan for orientation of new nurse faculty and clinical nurse faculty.</text> </paragraph> <paragraph num="B."> <text>A program of faculty development shall be offered to encourage and assist nurse faculty members and clinical nurse faculty in their professional growth and development.</text> </paragraph> <paragraph num="C."> <text>A variety of means shall be used to evaluate nurse faculty and clinical nurse faculty’s effectiveness of teaching within the classroom and clinical setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Resources, Facilities, and Services."> <paragraph num="A."> <text>Physical Facilities. The physical facilities shall be adequate to meet the needs of the nursing program and include the following:</text> <paragraph num="(1)"> <text>Office for the administrator, faculty members, and staff;</text> </paragraph> <paragraph num="(2)"> <text>Adequate space for privacy of faculty-student conferences;</text> </paragraph> <paragraph num="(3)"> <text>Classroom, laboratories, simulation laboratories, and conference rooms;</text> </paragraph> <paragraph num="(4)"> <text>Space for equipment and instructional materials; and</text> </paragraph> <paragraph num="(5)"> <text>Space for noninstructional activities of nursing faculty and students.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Learning resources shall be developed with faculty input and shall be:</text> <paragraph num="(1)"> <text>Accessible to faculty and students;</text> </paragraph> <paragraph num="(2)"> <text>Comprehensive; and</text> </paragraph> <paragraph num="(3)"> <text>Current.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Educational support services that facilitate students' abilities to achieve the program's objectives, outcomes, or competencies shall be available.</text> </paragraph> <paragraph num="D."> <text>Cooperating Clinical Agencies.</text> <paragraph num="(1)"> <text>The appropriate authorities shall approve cooperating clinical agencies and all facilities used for clinical learning experiences.</text> </paragraph> <paragraph num="(2)"> <text>Facilities with conditional or provisional approval status may not be used for student learning experiences.</text> </paragraph> <paragraph num="(3)"> <text>Cooperating clinical agencies shall meet the following requirements:</text> <paragraph num="(a)"> <text>Accreditation or approval by the appropriate authority;</text> </paragraph> <paragraph num="(b)"> <text>A sufficient number and variety of clients to provide learning experiences for all students to achieve the stated objectives, outcomes, or competencies;</text> </paragraph> <paragraph num="(c)"> <text>A sufficient number of registered nurses and other nursing personnel to ensure safe and continuous care of clients; and</text> </paragraph> <paragraph num="(d)"> <text>Conformance with accepted standards of nursing care and practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Written Agreements.</text> <paragraph num="(1)"> <text>Written agreements between the program and the cooperating clinical agencies shall specify the responsibility of the program to the cooperating clinical agency and the responsibility of the cooperating clinical agency to the program.</text> </paragraph> <paragraph num="(2)"> <text>Written agreements shall:</text> <paragraph num="(a)"> <text>Be developed jointly with the cooperating clinical agency;</text> </paragraph> <paragraph num="(b)"> <text>Be reviewed periodically; and</text> </paragraph> <paragraph num="(c)"> <text>Include provision for adequate notice of termination.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Curriculum."> <paragraph num="A."> <text>The curriculum shall be:</text> <paragraph num="(1)"> <text>Planned, implemented, and evaluated by the faculty;</text> </paragraph> <paragraph num="(2)"> <text>Based on the philosophy and program objectives, outcomes, or competencies;</text> </paragraph> <paragraph num="(3)"> <text>Organized logically and sequenced appropriately; and</text> </paragraph> <paragraph num="(4)"> <text>Based on sound educational principles.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The curriculum plan shall:</text> <paragraph num="(1)"> <text>Serve as the foundation for curriculum development;</text> </paragraph> <paragraph num="(2)"> <text>Define and organize philosophical beliefs, values, and concepts;</text> </paragraph> <paragraph num="(3)"> <text>Operationalize the program objectives or outcomes;</text> </paragraph> <paragraph num="(4)"> <text>Structure concepts and theories to enhance the teaching-learning process; and</text> </paragraph> <paragraph num="(5)"> <text>Provide a model for progressive learning.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The curriculum objectives, outcomes, or competencies shall:</text> <paragraph num="(1)"> <text>Flow from the curriculum plan;</text> </paragraph> <paragraph num="(2)"> <text>Measure the intended objectives, outcomes, or competencies for program graduates; and</text> </paragraph> <paragraph num="(3)"> <text>Serve as a foundation for:</text> <paragraph num="(a)"> <text>Sequencing of the program;</text> </paragraph> <paragraph num="(b)"> <text>Course objectives;</text> </paragraph> <paragraph num="(c)"> <text>Sequential arrangement of courses; and</text> </paragraph> <paragraph num="(d)"> <text>Distribution of class and clinical hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The curriculum of all programs shall:</text> <paragraph num="(1)"> <text>Be appropriate to the level of the graduate's intended scope of practice;</text> </paragraph> <paragraph num="(2)"> <text>Provide didactic and clinical learning experiences that are diverse and consistent with program objectives, outcomes, or competencies; and</text> </paragraph> <paragraph num="(3)"> <text>Include:</text> <paragraph num="(a)"> <text>Content in the arts and humanities, social and behavioral sciences, and biological and physical sciences;</text> </paragraph> <paragraph num="(b)"> <text>The nursing process;</text> </paragraph> <paragraph num="(c)"> <text>Didactic and clinical instruction which includes, but is not limited to, the following areas:</text> <paragraph num="(i)"> <text>Nursing care of families and clients throughout the life span in a variety of care settings requiring nursing measures appropriate for either the maintenance or restoration of mental and physical health;</text> </paragraph> <paragraph num="(ii)"> <text>Preventive, rehabilitative, and curative aspects of health care; and</text> </paragraph> <paragraph num="(iii)"> <text>Biophysical, psychosocial, cultural, and spiritual components of health and illness;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Professional issues content including, but not limited to:</text> <paragraph num="(i)"> <text>The historical development of nursing;</text> </paragraph> <paragraph num="(ii)"> <text>Current issues and trends in nursing; and</text> </paragraph> <paragraph num="(iii)"> <text>Ethical, legal, and professional aspects of nursing;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Multidisciplinary communication;</text> </paragraph> <paragraph num="(f)"> <text>Evidence based practice;</text> </paragraph> <paragraph num="(g)"> <text>Patient centered care;</text> </paragraph> <paragraph num="(h)"> <text>Quality improvement; and</text> </paragraph> <paragraph num="(i)"> <text>Informatics.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The curriculum of baccalaureate degree programs in nursing shall also include:</text> <paragraph num="(1)"> <text>Didactic and clinical experiences in community health nursing;</text> </paragraph> <paragraph num="(2)"> <text>Study of nursing research and its application to nursing; and</text> </paragraph> <paragraph num="(3)"> <text>Study and practice of leadership and management.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Course objectives, outcomes, or competencies shall serve as:</text> <paragraph num="(1)"> <text>Selection criteria for the location and type of clinical learning experiences; and</text> </paragraph> <paragraph num="(2)"> <text>A basis for evaluation of student performance.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Changes in course offerings that will alter the curriculum, philosophy, objectives, outcomes, competencies, or conceptual framework of the program shall:</text> <paragraph num="(1)"> <text>Be reported to the Board in the annual report; and</text> </paragraph> <paragraph num="(2)"> <text>Include the following information:</text> <paragraph num="(a)"> <text>The rationale for changes; and</text> </paragraph> <paragraph num="(b)"> <text>The methods of evaluation to be used to determine the effect of the change.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Students shall be provided didactic instruction either before or concurrent with the related clinical learning experiences.</text> </paragraph> <paragraph num="I."> <text>Clinical learning experiences shall be sufficient in quantity and quality to provide opportunities for students to achieve the stated objectives, outcomes, or competencies.</text> </paragraph> <paragraph num="J."> <text>Students shall have sufficient opportunities to develop the knowledge, skills, and abilities essential for a safe and effective nursing practice.</text> </paragraph> <paragraph num="K."> <text>Evaluation methods and tools used for measuring students’ knowledge, skills, and abilities shall be developed and implemented in order to ensure satisfactory progression of students.</text> </paragraph> <paragraph num="L."> <text>There shall be a rationale for the ratio of classroom to clinical hours for each clinical nursing course.</text> </paragraph> <paragraph num="M."> <text>Clinical Preceptorships.</text> <paragraph num="(1)"> <text>When clinical preceptors are used, the following conditions shall be met:</text> <paragraph num="(a)"> <text>Written agreements between the cooperating agency and the nursing program shall delineate the functions and responsibilities of the parties involved;</text> </paragraph> <paragraph num="(b)"> <text>There shall be written criteria for selecting clinical preceptors;</text> </paragraph> <paragraph num="(c)"> <text>The clinical preceptor shall have the following minimum qualifications:</text> <paragraph num="(i)"> <text>Current licensure as a registered nurse,</text> </paragraph> <paragraph num="(ii)"> <text>2 years of experience as a registered nurse and clinical expertise in the area of nursing required for the experience; and</text> </paragraph> <paragraph num="(iii)"> <text>A philosophy of health care congruent with that of the nursing program;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Written clinical objectives, outcomes, or competencies shall be specified and shared with the clinical preceptor before the preceptorship experience begins; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The designated faculty member shall:</text> <paragraph num="(a)"> <text>Be responsible for a student's learning experiences, and</text> </paragraph> <paragraph num="(b)"> <text>Meet regularly with the clinical preceptor and the student for the purpose of monitoring and evaluating learning experiences.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A bachelor’s degree in nursing is recommended.</text> </paragraph> <paragraph num="(4)"> <text>Nothing in this section shall be construed to prohibit any cooperating clinical agency’s registered nurses from assisting with clinical activities selected by the program’s nurse faculty or clinical nurse faculty.</text> </paragraph> <paragraph num="(5)"> <text>The program’s nurse faculty or clinical nurse faculty may not be required to be in the cooperating clinical agency’s facilities but shall be immediately available by telephone.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Students."> <paragraph num="A."> <text>The following shall be available to students:</text> <paragraph num="(1)"> <text>A written statement of students' rights and responsibilities;</text> </paragraph> <paragraph num="(2)"> <text>The opportunity to participate in program development and evaluation;</text> </paragraph> <paragraph num="(3)"> <text>A written grievance mechanism; and</text> </paragraph> <paragraph num="(4)"> <text>Guidance and advisement services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Students shall have:</text> <paragraph num="(1)"> <text>Membership on selected faculty committees, as appropriate; and</text> </paragraph> <paragraph num="(2)"> <text>The opportunity to participate in an organization of self-governance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Exercise of the right and responsibility to discuss, inquire, and express opinion is encouraged.</text> </paragraph> <paragraph num="D."> <text>Each program shall have clearly defined written policies for the following:</text> <paragraph num="(1)"> <text>Admission of:</text> <paragraph num="(a)"> <text>Generic students;</text> </paragraph> <paragraph num="(b)"> <text>Transfer students; and</text> </paragraph> <paragraph num="(c)"> <text>Articulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Oral and written English proficiency in reference to Health Occupations Article, §8-302(e), Annotated Code of Maryland, and COMAR 10.27.01.05;</text> </paragraph> <paragraph num="(3)"> <text>Withdrawals;</text> </paragraph> <paragraph num="(4)"> <text>Readmissions;</text> </paragraph> <paragraph num="(5)"> <text>Progression;</text> </paragraph> <paragraph num="(6)"> <text>Counseling and guidance;</text> </paragraph> <paragraph num="(7)"> <text>Representation on faculty governance;</text> </paragraph> <paragraph num="(8)"> <text>Graduation;</text> </paragraph> <paragraph num="(9)"> <text>Refund policies governing all fees and tuition paid by students; and</text> </paragraph> <paragraph num="(10)"> <text>Ethical practices for the performance of activities, including recruitment, admission, and advertising.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Each program shall have a written policy providing information to any student who may be subject to licensure denial under Health Occupations Article, §§-308(c) and 8-316(a), Annotated Code of Maryland, and amendments applying to that citation. The information shall be provided before admission to the nursing education program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Program Evaluation."> <paragraph num="A."> <text>The faculty shall develop and implement a Board-approved evaluation plan for evaluating the total nursing education program not less than:</text> <paragraph num="(1)"> <text>Every 10 years for programs that are accredited by a BRNAA; and</text> </paragraph> <paragraph num="(2)"> <text>5 years for programs without BRNAA accreditation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The evaluation plan shall include:</text> <paragraph num="(1)"> <text>All components of the program;</text> </paragraph> <paragraph num="(2)"> <text>Evaluation time intervals;</text> </paragraph> <paragraph num="(3)"> <text>Student, graduate, faculty, cooperating clinical agencies, and administration participation;</text> </paragraph> <paragraph num="(4)"> <text>Instruments or methods used; and</text> </paragraph> <paragraph num="(5)"> <text>Evidence that prior recommendations from the Board have been acted upon.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The evaluation process shall provide evidence that the program is meeting its objectives or outcomes as well as the changing needs of nursing and society.</text> </paragraph> <paragraph num="D."> <text>The outcome of evaluation includes:</text> <paragraph num="(1)"> <text>Recommendations for necessary program revisions; and</text> </paragraph> <paragraph num="(2)"> <text>Direction for future action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Annual Review."> <paragraph num="A."> <text>Annually, a program shall submit the following to the Board:</text> <paragraph num="(1)"> <text>An annual report on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>A program catalog;</text> </paragraph> <paragraph num="(3)"> <text>Any annual reports to the BRNAA;</text> </paragraph> <paragraph num="(4)"> <text>Any correspondence related to the status of the program's accreditation;</text> </paragraph> <paragraph num="(5)"> <text>A summary of practices followed in safeguarding the health and well-being of students;</text> </paragraph> <paragraph num="(6)"> <text>An audited fiscal report covering the previous 2 years, including a statement of income and expenditures; and</text> </paragraph> <paragraph num="(7)"> <text>Accurate and complete data including, but not limited to, number of enrollments, admissions, graduates, and faculty.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Annually, the Board shall:</text> <paragraph num="(1)"> <text>Review each program’s annual report, supporting documentation, and the licensure examination performance of first-time candidates from each program;</text> </paragraph> <paragraph num="(2)"> <text>Notify each program achieving less than 90 percent of the national success rate; and</text> </paragraph> <paragraph num="(3)"> <text>If necessary, conduct a survey or site visit, issue recommendations, place a program on conditional approval, or issue a formal notice of violation and withdraw approval in accordance with Regulation .17 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Approval may be reduced to conditional status for the following reasons:</text> <paragraph num="(1)"> <text>Noncompliance with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Failure to hire faculty who meet the qualifications as stated in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Noncompliance with the school’s stated philosophy, program design, objectives, or policies;</text> </paragraph> <paragraph num="(4)"> <text>Failure to submit records and reports to the Board in a timely manner;</text> </paragraph> <paragraph num="(5)"> <text>Failure to implement the approved curriculum;</text> </paragraph> <paragraph num="(6)"> <text>In accordance with §D of this regulation, failure to maintain the required passing rate on the licensing examination by first-time candidates;</text> </paragraph> <paragraph num="(7)"> <text>Failure to annually document that all faculty have current licenses; and</text> </paragraph> <paragraph num="(8)"> <text>Other activities or situations, as determined by the Board, that indicate a program is in jeopardy of violating statutory and regulatory requirements and standards.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Unacceptable Performance on Licensure Examination.</text> <paragraph num="(1)"> <text>The Board shall issue a warning to a program when the pass rate of first-time candidates does not comply with §B(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>For the first year a program does not meet the requirements of §B(2) of this regulation and following the warning in §D(1) of this regulation, the program shall, within 30 calendar days, provide to the Board:</text> <paragraph num="(a)"> <text>A report that identifies the factors believed to have contributed to the unacceptable performance; and</text> </paragraph> <paragraph num="(b)"> <text>An action plan to be approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Second Successive Year Not in Compliance.</text> <paragraph num="(a)"> <text>For the second successive year that a program is not in compliance with §B(2) of this regulation, the program shall be placed on conditional approval and shall:</text> <paragraph num="(i)"> <text>Provide the Board with a report analyzing all aspects of the educational program and identifying areas that may be contributing to the unacceptable performance; and</text> </paragraph> <paragraph num="(ii)"> <text>Obtain the services of a Board-approved outside consultant with expertise in nursing education congruent with program needs.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Board’s professional staff shall conduct a survey visit to the school and provide a report to the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If compliance with the minimum licensure examination performance standard for first-time candidates is not made by the program within 1 examination year from the date of conditional approval, approval may be withdrawn.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Removal from Approved List."> <paragraph num="A."> <text>Pursuant to Health Occupations Article, §8-404, Annotated Code of Maryland, at least 30 days before issuing a formal notice of violation of regulations to a program, the Board shall notify the chief administrator of the controlling institution and the chief administrator of the nursing education program that the Board is considering issuing a formal notice of violation.</text> </paragraph> <paragraph num="B."> <text>During the 30-day period, the Board shall provide the chief administrator of the controlling institution and the nursing education program with an opportunity to meet with representatives of the Board to discuss the Board’s proposed action against the program.</text> </paragraph> <paragraph num="C."> <text>The program shall notify the Board within the 30-day period if it is interested in meeting with the Board. If the program requests a meeting, the Board shall set up the meeting.</text> </paragraph> <paragraph num="D."> <text>At the meeting, the program shall submit to the Board a plan with a proposed time frame for correcting the violations.</text> </paragraph> <paragraph num="E."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Evaluate the plan;</text> </paragraph> <paragraph num="(2)"> <text>Approve or modify the plan; and</text> </paragraph> <paragraph num="(3)"> <text>Have discretion to make changes to the time frames for correcting violations or other components of the plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The program shall correct the violations within the time frames approved by the Board.</text> </paragraph> <paragraph num="G."> <text>Approval may be withdrawn for the following reasons:</text> <paragraph num="(1)"> <text>Noncompliance with any of the regulations in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Failure to hire faculty who meet the qualifications as stated in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Noncompliance with the school's stated philosophy, program design, objectives, or policies;</text> </paragraph> <paragraph num="(4)"> <text>Failure to submit records and reports to the Board in a timely manner;</text> </paragraph> <paragraph num="(5)"> <text>Failure to implement the approved curriculum;</text> </paragraph> <paragraph num="(6)"> <text>Failure to comply with the Board’s requirements within the specified time frames;</text> </paragraph> <paragraph num="(7)"> <text>Failure to maintain the required passing rate on the licensing examination by first-time writers;</text> </paragraph> <paragraph num="(8)"> <text>Failure to annually document that all faculty have current licenses; and</text> </paragraph> <paragraph num="(9)"> <text>Other activities or situations, as determined by the Board, that indicate a program is not meeting statutory and regulatory requirements and standards.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Withdrawal of Approval. If the program does not correct the violations within the approved time frames, the Board shall begin proceedings to remove the program from its list of institutions that offer approved nursing education programs in Maryland pursuant to Health Occupations Article, §§8-316—8-318, and 8-404, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="New Programs and Continuing Approval Requirements."> <paragraph num="A."> <text>New Program Requirements.</text> <paragraph num="(1)"> <text>An institution wishing to establish a nursing program shall submit to the Board:</text> <paragraph num="(a)"> <text>A letter of intent;</text> </paragraph> <paragraph num="(b)"> <text>Proof that the institution is accredited by the appropriate national or regional accrediting agency;</text> </paragraph> <paragraph num="(c)"> <text>A copy of the prospectus and program proposal submitted to MHEC;</text> </paragraph> <paragraph num="(d)"> <text>An addendum that describes in detail the:</text> <paragraph num="(i)"> <text>Type and length of nursing program;</text> </paragraph> <paragraph num="(ii)"> <text>Curriculum plan;</text> </paragraph> <paragraph num="(iii)"> <text>Program objectives, outcomes, or competencies; and</text> </paragraph> <paragraph num="(iv)"> <text>Description of available clinical resources;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Evidence that the proposed nursing program is based upon sound educational principles; and</text> </paragraph> <paragraph num="(f)"> <text>Materials validating that the educational institution is prepared to meet the requirements specified in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A nursing program providing on-site didactic or clinical instruction in Maryland shall comply with this chapter and receive Board approval of the on-site program before the commencement of instruction.</text> </paragraph> <paragraph num="(3)"> <text>Both MHEC and the Board shall collaborate on program review.</text> </paragraph> <paragraph num="(4)"> <text>Following review of the materials submitted, the Board shall notify the institution as to whether further clarifications or revisions are necessary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>New Program Review.</text> <paragraph num="(1)"> <text>The proposed nursing education program shall be reviewed at a regularly scheduled Board meeting.</text> </paragraph> <paragraph num="(2)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Deny further consideration of the proposal;</text> </paragraph> <paragraph num="(b)"> <text>Defer action on the proposal; or</text> </paragraph> <paragraph num="(c)"> <text>Authorize a site visit by the Board’s professional staff and, following a report of the site visit by the Board’s professional staff, grant initial approval, defer action, or deny the request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If deferred or denied, the institution shall be notified in writing of the reasons for the action.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Initial Approval. Initial approval:</text> <paragraph num="(1)"> <text>Is required before the admission of students;</text> </paragraph> <paragraph num="(2)"> <text>Requires concurrence of the Maryland Higher Education Commission; and</text> </paragraph> <paragraph num="(3)"> <text>Extends until the school or program has graduated its first class.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Approval.</text> <paragraph num="(1)"> <text>Following graduation of the first class, the Board shall evaluate the program for approval, considering the:</text> <paragraph num="(a)"> <text>Report of a survey of the program by the Board’s professional staff, scheduled before graduation of the first class;</text> </paragraph> <paragraph num="(b)"> <text>Results of the performance of the graduates on the National Council Licensure Examination; and</text> </paragraph> <paragraph num="(c)"> <text>Program’s demonstrated continued ability to provide an educational program that meets the standards set by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon review of the survey report, the results of graduate performance on the National Council Licensure Examination, and an assessment of the program’s continued ability to meet the standards set forth in this chapter, the Board may:</text> <paragraph num="(a)"> <text>Grant approval;</text> </paragraph> <paragraph num="(b)"> <text>Place the program on conditional approval; or</text> </paragraph> <paragraph num="(c)"> <text>Withdraw initial approval in accordance with Regulation .17 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Approval, if granted, shall be valid for not more than:</text> <paragraph num="(a)"> <text>10 years for a program accredited by a BRNAA; and</text> </paragraph> <paragraph num="(b)"> <text>5 years for a program without BRNAA accreditation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reapproval Requirements.</text> <paragraph num="(1)"> <text>The Board shall evaluate a program for reapproval:</text> <paragraph num="(a)"> <text>Every 5 years if the program is without BRNAA accreditation; and</text> </paragraph> <paragraph num="(b)"> <text>Not more than 10 years after approval is granted if the program has BRNAA accreditation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evaluation of continuing compliance shall include the submission of a self-study report by the program and a survey visit by the Board’s professional staff. The self-study report shall be submitted to the Board no less than one month prior to the survey visit.</text> </paragraph> <paragraph num="(3)"> <text>If the program is accredited by a BRNAA, the reapproval survey visit may be made in coordination with a BRNAA visit.</text> </paragraph> <paragraph num="(4)"> <text>Unscheduled survey or site visits may be conducted at the discretion of the Board.</text> </paragraph> <paragraph num="(5)"> <text>A program that is accredited by a BRNAA and is subsequently placed on warning or whose accreditation by the BRNAA is withdrawn shall be scheduled immediately for a survey visit.</text> </paragraph> <paragraph num="(6)"> <text>During each survey or site visit, the nurse administrator of the program shall make the following information available:</text> <paragraph num="(a)"> <text>Data about the program, including the following:</text> <paragraph num="(i)"> <text>The number of students;</text> </paragraph> <paragraph num="(ii)"> <text>The legal body responsible for policy and support of the program;</text> </paragraph> <paragraph num="(iii)"> <text>The organizational chart; and</text> </paragraph> <paragraph num="(iv)"> <text>An audited fiscal report covering the previous 2 years, including a statement of income and expenditures;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The nurse administrator’s job description;</text> </paragraph> <paragraph num="(c)"> <text>For each faculty member and clinical preceptor, the following:</text> <paragraph num="(i)"> <text>Job descriptions;</text> </paragraph> <paragraph num="(ii)"> <text>Selection policies;</text> </paragraph> <paragraph num="(iii)"> <text>Orientation plan;</text> </paragraph> <paragraph num="(iv)"> <text>Faculty organization by-laws;</text> </paragraph> <paragraph num="(v)"> <text>Number of full-time and part-time faculty and non-nursing faculty with academic credentials and assignments; and</text> </paragraph> <paragraph num="(vi)"> <text>Faculty-student clinical ratio;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Degree plan;</text> </paragraph> <paragraph num="(e)"> <text>A copy of the current curriculum and course catalog with the date of last revision;</text> </paragraph> <paragraph num="(f)"> <text>The testing process with test analysis and the written test procedure;</text> </paragraph> <paragraph num="(g)"> <text>A description of education facilities, including classrooms, offices, libraries, and computers;</text> </paragraph> <paragraph num="(h)"> <text>A list of clinical facilities and cooperating clinical agencies;</text> </paragraph> <paragraph num="(i)"> <text>The number of students by classes; and</text> </paragraph> <paragraph num="(j)"> <text>The policies for students as listed in Regulation .14D of this chapter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>During each survey or site visit, the nurse administrator shall make available the following:</text> <paragraph num="(a)"> <text>The program’s administrators, faculty, support services personnel, and students;</text> </paragraph> <paragraph num="(b)"> <text>Staff members of selected cooperating clinical agencies;</text> </paragraph> <paragraph num="(c)"> <text>Faculty minutes for at least the previous 3 years;</text> </paragraph> <paragraph num="(d)"> <text>Faculty and student handbooks;</text> </paragraph> <paragraph num="(e)"> <text>Student records;</text> </paragraph> <paragraph num="(f)"> <text>Policies and procedures;</text> </paragraph> <paragraph num="(g)"> <text>Curriculum materials;</text> </paragraph> <paragraph num="(h)"> <text>Cooperating clinical agency contractual agreements;</text> </paragraph> <paragraph num="(i)"> <text>Program evaluation plan and evidence of program effectiveness; and</text> </paragraph> <paragraph num="(j)"> <text>The program’s current catalog.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Upon review of the survey report and the results of graduate performance on the National Council Licensure Exam, and an assessment of the program’s continued ability to meet the standards set forth in this chapter, the Board may:</text> <paragraph num="(a)"> <text>Grant reapproval;</text> </paragraph> <paragraph num="(b)"> <text>Place the program on conditional approval; or</text> </paragraph> <paragraph num="(c)"> <text>Withdraw approval in accordance with Regulation .17 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Reapproval, if granted, shall be valid for not more than:</text> <paragraph num="(a)"> <text>10 years for a program accredited by a BRNAA; and</text> </paragraph> <paragraph num="(b)"> <text>5 years for a program without BRNAA accreditation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Closure of Programs."> <paragraph num="A."> <text>Upon request, the Board shall provide consultation concerning closing of a program.</text> </paragraph> <paragraph num="B."> <text>Upon the decision by a program to close, and at least 90 days before closing, the nurse administrator shall notify the Board of its intent, giving the following information:</text> <paragraph num="(1)"> <text>Date and reason for closing;</text> </paragraph> <paragraph num="(2)"> <text>Plans for phasing out the program;</text> </paragraph> <paragraph num="(3)"> <text>Disposition of the records of students, graduates, and faculty; and</text> </paragraph> <paragraph num="(4)"> <text>Title of the position of the individual to be responsible for the records and the name of the agency in which the records will be located.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205, 8-401, and 8-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 16, 1975 (2:8 Md. R. 566)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 30, 1982 (9:17 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 21, 1983 (10:23 Md. R. 2064); August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed and new Regulation .08 adopted effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective November 21, 1983 (10:23 Md. R. 2064)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective August 11, 1986 (13:16 Md. R. 1827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective November 21, 1983 (10:23 Md. R. 2064)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective November 21, 1983 (10:23 Md. R. 2064)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective September 30, 1991 (18:19 Md. R. 2100)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .06, .07, .09, and .11 amended as an emergency provision effective April 11, 1994 (21:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 1, 1994 (21:15 Md. R. 1305); February 12, 1996 (23:3 Md. R. 169)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D amended effective August 1, 1994 (21:15 Md. R. 1305)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.20, Registered Nursing Education Programs, repealed and new Regulations .01—.19, Nursing Education Programs, adopted effective August 10, 1998 (25:16 Md. R. 1274)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 5, 2001 (28:4 Md. R. 418)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended effective July 18, 2005 (32:14 Md. R. 1276)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I amended effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective February 18, 2002 (29:3 Md. R. 220); July 18, 2005 (32:14 Md. R. 1276)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective August 1, 2003 (30:19 Md. R. 1327); amended permanently effective January 5, 2004 (30:26 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended as an emergency provision effective May 23, 2008 (35:13 Md. R. 1178); amended permanently effective August 25, 2008 (35:17 Md. R. 1489)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective November 3, 2008 (35:24 Md. R. 2069); revised permanently effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, C amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D, E amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 22, 2021 (48:4 Md. R. 177)</annotation> </annotations> </chapter> <chapter num="04" heading="Methadone Dispensing"> <regulation prefix="Regulation" num=".01" heading="Dispensing Methadone."> <paragraph num="A."> <text>A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health may dispense methadone in accordance with:</text> <paragraph num="(1)"> <text>The patient's standing medication order;</text> </paragraph> <paragraph num="(2)"> <text>The methadone clinic's policies and procedures for dispensing methadone; and</text> </paragraph> <paragraph num="(3)"> <text>State and federal laws and regulations for labeling.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health shall dispense methadone:</text> <paragraph num="(1)"> <text>In tamper evident containers;</text> </paragraph> <paragraph num="(2)"> <text>In child resistant containers; and</text> </paragraph> <paragraph num="(3)"> <text>With any required patient information documents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health shall maintain records of methadone dispensed in accordance with the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A registered nurse or licensed practical nurse may not delegate the dispensing of methadone.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1) and 8-511, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 9, 2009 (36:3 Md. R. 209)</annotation> </annotations> </chapter> <chapter num="05" heading="Practice of Nurse Midwifery"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ACME” means the Accreditation Commission for Midwifery Education.</text> </paragraph> <paragraph num="(2)"> <text>“ACNM” means the American College of Nurse Midwives.</text> </paragraph> <paragraph num="(3)"> <text>“Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as:</text> <paragraph num="(a)"> <text>A certified nurse midwife (CNM);</text> </paragraph> <paragraph num="(b)"> <text>A certified registered nurse anesthetist (CRNA);</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse practitioner (CRNP); or</text> </paragraph> <paragraph num="(d)"> <text>A clinical nurse specialist (CNS).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“AMCB” means the American Midwifery Certification Board.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(6)"> <text>“Certification” means the permission to practice nurse midwifery granted by the Board to a registered nurse who has:</text> <paragraph num="(a)"> <text>Met all the specified requirements of a national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Complied with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certified nurse midwife” means an advanced practice registered nurse who is certified by the Board to practice nurse midwifery in this State.</text> </paragraph> <paragraph num="(8)"> <text>“Clinical practice guidelines” standards for practice of midwifery using current guidelines established by ACNM in Standards for the Practice of Midwifery.</text> </paragraph> <paragraph num="(9)"> <text>“Delegated medical functions” means those functions that come within the definition of “practice medicine” in the Health Occupations Article, §14-101, Annotated Code of Maryland, that have been delegated to a certified nurse midwife to perform.</text> </paragraph> <paragraph num="(10)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(11)"> <text>“Newborn” means an infant in the first 28 days after birth.</text> </paragraph> <paragraph num="(12)"> <text>“Nurse midwifery” means the health care management of newborns and clients throughout their reproductive life cycle.</text> </paragraph> <paragraph num="(13)"> <text>“Physician” means an individual licensed to practice medicine in this State.</text> </paragraph> <paragraph num="(14)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification."> <paragraph num="A."> <text>An applicant for certification as a nurse midwife shall:</text> <paragraph num="(1)"> <text>Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(2)"> <text>Have graduated from a Board-approved graduate level program for nurse midwives at the Masters’ level or higher that is accredited by:</text> <paragraph num="(a)"> <text>The National League for Nursing Accreditation Commission (NLNAC);</text> </paragraph> <paragraph num="(b)"> <text>The Commission on Nursing Education (CCNE);</text> </paragraph> <paragraph num="(c)"> <text>ACME; or</text> </paragraph> <paragraph num="(d)"> <text>Any other accrediting body recognized by the Board;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Hold a current national certification as a nurse midwife from the AMCB or any other national certifying body recognized by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Submit to the Board a completed application for certification as a nurse midwife;</text> </paragraph> <paragraph num="(5)"> <text>Submit an affidavit that the applicant agrees to comply at all times with the clinical practice guidelines in accordance with Regulation .01B(8) of this chapter when providing clinical midwifery services;</text> </paragraph> <paragraph num="(6)"> <text>Comply with all the requirement set forth in COMAR 10.27.01.04;</text> </paragraph> <paragraph num="(7)"> <text>Demonstrate written and oral competency in the English language; and</text> </paragraph> <paragraph num="(8)"> <text>Pay all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the applicant’s nurse midwifery program was completed before July 1, 2014, and was not at a Master’s degree or higher level, but the applicant otherwise qualifies for certification, the applicant shall provide the Board with:</text> <paragraph num="(1)"> <text>Verification of completion of a nurse midwifery program recognized by AMCB; and</text> </paragraph> <paragraph num="(2)"> <text>Current national certification by AMCB or any other national certifying body recognized by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Duties of the Board."> <text>The Board shall:</text> <paragraph num="A."> <text>Maintain an up-to-date list of all certified nurse midwives in this State; and</text> </paragraph> <paragraph num="B."> <text>Include on the nurse midwife's registered nursing license an indication that the licensee is certified as a nurse midwife.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Required Documentation."> <paragraph num="A."> <text>A certified nurse midwife who provides clinical midwifery services across the reproductive lifespan shall:</text> <paragraph num="(1)"> <text>Maintain a medical record for each client; and</text> </paragraph> <paragraph num="(2)"> <text>In the case of a transfer of care to another provider or a facility, transfer the client’s medical records with the client.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A certified nurse midwife who provides clinical midwifery services shall have available at all times for examination by the Board, written clinical practice guidelines that cover all aspects of care, practice, and quality assurance, including but not limited to:</text> <paragraph num="(1)"> <text>A plan for emergency consultation;</text> </paragraph> <paragraph num="(2)"> <text>A plan for transfer of care; and</text> </paragraph> <paragraph num="(3)"> <text>If needed, a plan for admission of the client or newborn to a hospital within the client’s geographic area.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Practice Before Certification."> <paragraph num="A."> <text>A registered nurse who meets the qualifications to sit for the AMCB national certifying examination or any other certifying examination approved by the Board who has taken that examination and is waiting for the results of it may practice as a nurse midwife graduate before certification if the:</text> <paragraph num="(1)"> <text>Practice is under the supervision of a certified nurse midwife who shall be physically available to the nurse midwife graduate;</text> </paragraph> <paragraph num="(2)"> <text>Supervising certified nurse midwife signs a written supervision agreement on the required form to provide the supervision; and</text> </paragraph> <paragraph num="(3)"> <text>Nurse midwife graduate files with the Board a copy of the admission slip to the Board-approved certifying examination and a copy of the signed supervision agreement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse midwife graduate who has entered into a supervision agreement under this regulation shall immediately notify the Board and the supervising certified nurse midwife of the results of the Board-approved certifying examination.</text> </paragraph> <paragraph num="C."> <text>A nurse midwife graduate may not continue to practice under a supervision agreement under this regulation for more than 1 year from the filing of all documents required under §A of this regulation, or after the denial of AMCB or other Board-approved certification, whichever occurs first.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Scope of Practice."> <paragraph num="A."> <text>A certified nurse midwife who meets the requirements of Regulation .02 of this chapter may perform the following functions:</text> <paragraph num="(1)"> <text>Independent management of clients appropriate to the skill and educational preparation of the certified nurse midwife and the nurse midwife's clinical practice guidelines;</text> </paragraph> <paragraph num="(2)"> <text>Consult or collaborate with a physician or other health care provider as needed; and</text> </paragraph> <paragraph num="(3)"> <text>Refer clients with complications beyond the scope of practice of the certified nurse midwife to a licensed physician.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A certified nurse midwife shall keep a record of all cases attended and maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A certified nurse midwife has the right and obligation to refuse to perform any delegated medical act, oral or written, if, in the certified nurse midwife’s judgment, it is unsafe or an invalidly prescribed medical act or beyond the competence of the certified nurse midwife, in which case the nurse midwife shall notify the delegating physician at once.</text> </paragraph> <paragraph num="D."> <text>A certified nurse midwife shall comply with applicable State and federal law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Nurse Midwife Peer Review Advisory Committee. — Repealed." /> <regulation prefix="Regulation" num=".08" heading="Renewal of Certification."> <paragraph num="A."> <text>Certification as a nurse midwife expires at the same time as the nurse midwife's registered nursing license unless the certification is renewed.</text> </paragraph> <paragraph num="B."> <text>Before a nurse midwife’s certification expires, the nurse midwife may renew the certification biennially if the nurse midwife:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>Documentation of a current national certification as a nurse midwife from AMCB or another national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>A completed renewal application on the form that the Board requires; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certified nurse midwife renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J — N.</text> </paragraph> <paragraph num="D."> <text>The certified nurse midwife shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date.</text> </paragraph> <paragraph num="E."> <text>Certification as a nurse midwife shall be deemed to have lapsed if the Board does not have a record of a current active national certification.</text> </paragraph> <paragraph num="F."> <text>Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Compliance."> <text>The certified nurse midwife shall develop and comply with clinical practice guidelines as defined in Regulation .01B of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Unlawful Practices."> <text>Pursuant to Health Occupations Article, Title 8, Subtitle 7, Annotated Code of Maryland, an individual may not:</text> <paragraph num="A."> <text>Practice nurse midwifery unless certified under these regulations or otherwise permitted by law to engage in those activities;</text> </paragraph> <paragraph num="B."> <text>Use the title nurse midwife, certified nurse midwife, or any other similar designation unless certified by the AMCB, or other certifying body approved by the Board; or</text> </paragraph> <paragraph num="C."> <text>Use the title certified nurse midwife unless certified by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Prescribing of Substances by a Certified Nurse Midwife."> <text>Pursuant to Health Occupations Article, §8-601, Annotated Code of Maryland, a certified nurse midwife may prescribe:</text> <paragraph num="A."> <text>Substances commonly used in the practice of nurse midwifery; and</text> </paragraph> <paragraph num="B."> <text>Controlled substances on Schedules II-V under Criminal Law Article, §§5-403 — 5-406, Annotated Code of Maryland, commonly used in the practice of nurse midwifery; and</text> </paragraph> <paragraph num="C."> <text>Dispense substances prescribed in accordance with §§A and B of this regulation in the course of treating a client at a:</text> <paragraph num="(1)"> <text>Nonprofit medical facility or clinic;</text> </paragraph> <paragraph num="(2)"> <text>Health center operating on the campus of an institution of higher learning;</text> </paragraph> <paragraph num="(3)"> <text>Public health facility;</text> </paragraph> <paragraph num="(4)"> <text>Medical facility under contract with a State or local health department; or</text> </paragraph> <paragraph num="(5)"> <text>Facility funded with public funds.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-101, 8-205, and 8-601—8-603, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective March 14, 1983 (10:11 Md. R. 970); emergency status expired July 13, 1983; adopted permanently effective October 10, 1983 (10:20 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 2, 1991 (18:17 Md. R. 1919); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 2, 1991 (18:17 Md. R. 1919)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed effective April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 10, 1995 (22:7 Md. R. 536); March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective September 2, 1991 (18:17 Md. R. 1919)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 10, 1995 (22:7 Md. R. 536); March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); revised permanently effective June 28, 2010 (37:13 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 29, 2014 (41:19 Md. R. 1079)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); October 13, 2025 (Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 13, 2025 (Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective October 13, 2025 (Md. R. 1001)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed effective February 22, 2026 (52:17 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.11 Midwifery was replaced by COMAR 10.27.05 Practice of Nurse Midwifery</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.11 Midwifery adopted effective February 1, 1957; repealed effective July 12, 1987 (14:14 Md. R. 1572)</annotation> </annotations> </chapter> <chapter num="06" heading="Practice of Nurse Anesthetist"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“A.A.N.A.” means the American Association of Nurse Anesthetists.</text> </paragraph> <paragraph num="(2)"> <text>“Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as:</text> <paragraph num="(a)"> <text>A certified nurse midwife (CNM);</text> </paragraph> <paragraph num="(b)"> <text>A certified registered nurse anesthetist (CRNA);</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse practitioner (CRNP); or</text> </paragraph> <paragraph num="(d)"> <text>A clinical nurse specialist (CNS).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Anesthesiologist” means a Maryland-licensed physician who:</text> <paragraph num="(a)"> <text>Has had special training in the field of anesthesiology;</text> </paragraph> <paragraph num="(b)"> <text>Administers anesthesia on a regular basis; and</text> </paragraph> <paragraph num="(c)"> <text>Devotes a substantial portion of the physician's medical practice to the practice of anesthesiology.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>“Certification” means the permission to practice nurse anesthesia granted by the Board to a registered nurse who has:</text> <paragraph num="(a)"> <text>Met all the specified requirements of a national certifying body recognized by the <MLF>Board; and</text> </paragraph> <paragraph num="(b)"> <text>Complied with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Certified registered nurse anesthetist (CRNA)” means an advanced practice registered nurse who is certified by the Board to practice as a nurse anesthetist in this State.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed physician or dentist” means a Maryland-licensed physician or dentist who has knowledge and experience in resuscitation, anesthetic drugs, and their reactions.</text> </paragraph> <paragraph num="(8)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(9)"> <text>“Perioperative assessment and management” means the assessment and management of the patient preoperatively, intraoperatively, and postoperatively.</text> </paragraph> <paragraph num="(10)"> <text>“Practice of nurse anesthesia” means the performance of acts in collaboration with an anesthesiologist, licensed physician, or dentist, which require substantial specialized knowledge, judgment, and skill related to the administration of anesthesia, including:</text> <paragraph num="(a)"> <text>Perioperative assessment and management of patients requiring anesthesia services;</text> </paragraph> <paragraph num="(b)"> <text>Administering anesthetics;</text> </paragraph> <paragraph num="(c)"> <text>Management of fluid in intravenous therapy; and</text> </paragraph> <paragraph num="(d)"> <text>Respiratory care.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Qualified anesthesia provider” means a physician, dentist, or certified registered nurse anesthetist trained and duly authorized under the respective provisions of the Health Occupations Article to administer local, regional, and general anesthesia.</text> </paragraph> <paragraph num="(12)"> <text>“Registered Nurse” means an individual who is licensed by the Board to practice registered nursing or has a multistate licensure privilege to practice registered nursing in this State under the Nurse Licensure Compact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification."> <paragraph num="A."> <text>An applicant for certification as a CRNA shall:</text> <paragraph num="(1)"> <text>Hold a current Maryland license in good standing or a multistate licensure privilege to practice registered nursing in this State under the Nurse Licensure Compact;</text> </paragraph> <paragraph num="(2)"> <text>Have graduated from an education program in nurse anesthesia approved by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Hold current national certification from the Council on Certification of Nurse Anesthetists or from another national certifying body recognized by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Submit to the Board a completed application for certification as a nurse anesthetist;</text> </paragraph> <paragraph num="(5)"> <text>Comply with all the requirements set forth in COMAR 10.27.01.04;</text> </paragraph> <paragraph num="(6)"> <text>Demonstrate oral and written competency in the English language; and</text> </paragraph> <paragraph num="(7)"> <text>Pay all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the applicant’s nurse anesthetist program was completed after January 1, 2008, the applicant for certification as a CRNA shall also provide to the Board documentation that the applicant graduated from a graduate level accredited nurse anesthetist program with a master’s degree or higher.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Practice Before Certification."> <paragraph num="A."> <text>A registered nurse who has completed a program for preparation of nurse anesthetists and who has applied to take a national certifying examination acceptable to the Board may practice as a nurse anesthetist graduate before certification in the State, on approval of the Board, if the nurse:</text> <paragraph num="(1)"> <text>Has a current license or multistate privilege to practice registered nursing in the State;</text> </paragraph> <paragraph num="(2)"> <text>Submitted in full the application for State certification as a CRNA;</text> </paragraph> <paragraph num="(3)"> <text>Paid all fees established by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Completed a nurse anesthetist program approved by the Board;</text> </paragraph> <paragraph num="(5)"> <text>Practices under the supervision of an anesthesiologist or CRNA and the supervisor is on site and immediately available to the nurse anesthetist graduate;</text> </paragraph> <paragraph num="(6)"> <text>Provides the Board a copy of the admission document to the national certification examination which must be taken not later than 6 months after program completion; and</text> </paragraph> <paragraph num="(7)"> <text>Immediately notifies the Board and the supervising anesthesiologist or CRNA of the results of the certification examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse anesthetist graduate who fails the national certification examination shall immediately cease practice as a nurse anesthetist graduate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Renewal of Certification."> <paragraph num="A."> <text>Certification as a nurse anesthetist expires at the same time as the nurse anesthetist's registered nursing license unless the certification is renewed.</text> </paragraph> <paragraph num="B."> <text>Before a nurse anesthetist’s certification expires, the nurse anesthetist may renew the certification biennially, if the nurse anesthetist:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Pays all appropriate renewal fees set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A completed renewal application on the form required by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation of a current national certification as a nurse anesthetist from the Council on Certification of Nurse Anesthetists or some other national certifying body recognized by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Nurse anesthetist renewal applicants who are authorized to practice registered nursing in this State under a multistate privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J—N.</text> </paragraph> <paragraph num="D."> <text>The nurse anesthetist shall ensure that the Board has a record of the renewed national certification if the national certification expires before the renewal date.</text> </paragraph> <paragraph num="E."> <text>Practicing on an expired national certification is prohibited and subject to disciplinary action under Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of Practice."> <paragraph num="A."> <text>A nurse anesthetist may perform the following functions:</text> <paragraph num="(1)"> <text>Perioperative assessment and management of patients requiring anesthesia services;</text> </paragraph> <paragraph num="(2)"> <text>Administration of anesthetic agents;</text> </paragraph> <paragraph num="(3)"> <text>Management of fluids in intravenous therapy;</text> </paragraph> <paragraph num="(4)"> <text>Respiratory care; and</text> </paragraph> <paragraph num="(5)"> <text>In accordance with §D of this regulation, prescribe, order, and administer drugs, including a drug that is classified as a controlled dangerous substance under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse anesthetist has the right and obligation to refuse to perform a delegated act if, in the nurse anesthetist’s judgment, the act is:</text> <paragraph num="(1)"> <text>Unsafe;</text> </paragraph> <paragraph num="(2)"> <text>An invalidly prescribed medical act; or</text> </paragraph> <paragraph num="(3)"> <text>Beyond the clinical skills of the nurse anesthetist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Section A of this regulation may not be construed to authorize a nurse anesthetist to:</text> <paragraph num="(1)"> <text>Diagnose a medical condition;</text> </paragraph> <paragraph num="(2)"> <text>Provide care that is not consistent with the scope of practice of nurse anesthetists; or</text> </paragraph> <paragraph num="(3)"> <text>Provide care for which the nurse anesthetist does not have proper education and experience.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A nurse anesthetist may prescribe drugs in accordance with §A of this regulation:</text> <paragraph num="(1)"> <text>Only in an amount that does not exceed a 10-day supply;</text> </paragraph> <paragraph num="(2)"> <text>Only for an individual with whom the nurse anesthetist has, at the time of prescription, established a client or patient record; and</text> </paragraph> <paragraph num="(3)"> <text>Only in connection with the delivery of anesthesia services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standards of Practice."> <paragraph num="A."> <text>A nurse anesthetist shall collaborate with an anesthesiologist, licensed physician, or dentist in the following manner:</text> <paragraph num="(1)"> <text>An anesthesiologist, licensed physician, or dentist shall be physically available to the nurse anesthetist for consultation at all times during the administration of, and recovery from, anesthesia;</text> </paragraph> <paragraph num="(2)"> <text>An anesthesiologist shall be available for consultation to the nurse anesthetist for other aspects of the practice of nurse anesthesia; and</text> </paragraph> <paragraph num="(3)"> <text>If an anesthesiologist is not available, a licensed physician or dentist shall be available to provide this type of consultation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nurse anesthetist shall assure that a qualified anesthesia provider:</text> <paragraph num="(1)"> <text>Performs a thorough and complete preanesthetic assessment;</text> </paragraph> <paragraph num="(2)"> <text>Obtains informed consent for the planned anesthetic intervention from the patient or responsible other; and</text> </paragraph> <paragraph num="(3)"> <text>Formulates a patient-specific plan for anesthesia care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The nurse anesthetist as part of the standards of practice shall:</text> <paragraph num="(1)"> <text>Implement and adjust the anesthesia care plan as needed to adapt to the patient's response to the anesthesia;</text> </paragraph> <paragraph num="(2)"> <text>Monitor the patient's physiologic condition for untoward identifiable reactions and initiate appropriate corrective actions as required;</text> </paragraph> <paragraph num="(3)"> <text>Enter prompt, complete, and accurate documentation of pertinent information on the patient's record;</text> </paragraph> <paragraph num="(4)"> <text>Transfer responsibility for care of the patient to other qualified providers in a manner which assures continuity of care and patient safety;</text> </paragraph> <paragraph num="(5)"> <text>Ensure that appropriate safety precautions are taken to minimize the risks of fire, explosion, electrical shock, and equipment malfunction;</text> </paragraph> <paragraph num="(6)"> <text>Maintain appropriate infection control standards;</text> </paragraph> <paragraph num="(7)"> <text>Evaluate anesthesia care to assure its quality;</text> </paragraph> <paragraph num="(8)"> <text>Maintain continual competence in anesthesia practice;</text> </paragraph> <paragraph num="(9)"> <text>Respect and maintain the basic rights of patients; and</text> </paragraph> <paragraph num="(10)"> <text>Maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Unlawful Practices."> <paragraph num="A."> <text>Under Health Occupations Article, Title 8, Subtitle 7, Annotated Code of Maryland, a person may not:</text> <paragraph num="(1)"> <text>Practice nurse anesthesia unless certified under this chapter, or otherwise permitted by law to engage in these activities; or</text> </paragraph> <paragraph num="(2)"> <text>Use the title nurse anesthetist, or any other words, letters, or symbols with the intent to represent that the individual is a nurse anesthetist unless certified by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person certified under this chapter is subject to the disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>This chapter does not limit or prohibit a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="CRNA Peer Review/Advisory Committee."> <paragraph num="A."> <text>The Board shall appoint at least four CRNAs to act as the Board's advisory committee.</text> </paragraph> <paragraph num="B."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Meet at least four times a year;</text> </paragraph> <paragraph num="(2)"> <text>Report at least annually on its overall activities; and</text> </paragraph> <paragraph num="(3)"> <text>Function at the Board's direction and provide the Board with expert advice related to the practice of nurse anesthesia.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Members of the Committee shall be appointed for a 4-year term and may be reappointed for one additional 4-year term.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1), (3), (4), and (5), and 8-513; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 1, 1979 (6:21 Md. R. 1709)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.08 adopted effective April 3, 2000 (27:6 Md. R. 642)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 23, 2006 (33:23 Md. R. 1796); June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 18, 2007 (34:12 Md. R. 1067)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C—E adopted effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective January 19, 2026 (53:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective January 19, 2026 (53:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective June 17, 2019 (46:12 Md. R. 544); October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="07" heading="Practice of the Nurse Practitioner"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“AANPNCB” means the American Academy of Nurse Practitioners National Certification Board.</text> </paragraph> <paragraph num="(2)"> <text>“Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as:</text> <paragraph num="(a)"> <text>A certified nurse midwife (CNM);</text> </paragraph> <paragraph num="(b)"> <text>A certified registered nurse anesthetist (CRNA);</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse practitioner (CRNP); or</text> </paragraph> <paragraph num="(d)"> <text>A clinical nurse specialist (CNS).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Certification” means permission to practice as a nurse practitioner granted by the Board to a registered nurse who has:</text> <paragraph num="(a)"> <text>Met all the specified requirement of a national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Complied with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Collaborating” means a cooperative relationship with other health care providers.</text> </paragraph> <paragraph num="(6)"> <text>“Facility” means a health care facility as defined under Health-General Article, §19-114(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Mentor” means a certified nurse practitioner or physician, licensed in Maryland, who:</text> <paragraph num="(a)"> <text>Has 3 or more years of clinical practice experience; and</text> </paragraph> <paragraph num="(b)"> <text>Will be available for advice, consultation, and collaboration, as needed, for 18 months beginning on the date an application is received by the Board from an applicant who has never been certified in this or any other State.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(9)"> <text>“Nurse practitioner” means an advanced practice registered nurse who is certified by the Board to practice as a nurse practitioner in this State.</text> </paragraph> <paragraph num="(10)"> <text>“Personally prepare and dispense” means that a nurse practitioner:</text> <paragraph num="(a)"> <text>Is physically present on the premises where the prescription is filled; and</text> </paragraph> <paragraph num="(b)"> <text>Performs a final check of the prescription before the prescription is provided to the patient.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Physician” means an individual who has an unencumbered license to practice medicine, issued under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Starter dosage” means an amount of a drug sufficient to begin therapy:</text> <paragraph num="(a)"> <text>Of a short duration of 72 hours or less; or</text> </paragraph> <paragraph num="(b)"> <text>Before obtaining a larger quantity of the drug to complete therapy.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Unencumbered license” means a license that is not:</text> <paragraph num="(a)"> <text>Revoked;</text> </paragraph> <paragraph num="(b)"> <text>Suspended; or</text> </paragraph> <paragraph num="(c)"> <text>On probationary status.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification."> <paragraph num="A."> <text>An applicant for certification as a nurse practitioner shall obtain certification from the Board before commencing practice.</text> </paragraph> <paragraph num="B."> <text>An applicant for certification as a nurse practitioner shall:</text> <paragraph num="(1)"> <text>Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(2)"> <text>Have graduated from a Board-approved accredited graduate level program for nurse practitioners at the Masters’ level or higher that meets the requirements of Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Hold a current national certification:</text> <paragraph num="(a)"> <text>For each area of specialization in which certification is sought; and</text> </paragraph> <paragraph num="(b)"> <text>From the AANPNCB or other national certifying body recognized by the Board;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submit to the Board a completed application for certification as a nurse practitioner for each area of specialization in which certification is sought;</text> </paragraph> <paragraph num="(5)"> <text>Comply with all the requirements set forth in COMAR 10.27.01.04;</text> </paragraph> <paragraph num="(6)"> <text>Demonstrate written and oral competency in the English language;</text> </paragraph> <paragraph num="(7)"> <text>If the applicant has not been certified by the Board or any other Board of Nursing, identify a designated mentor for 18 months as defined in Regulation .01 of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Pay all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Maintain an up-to-date list of all nurse practitioners certified in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Include on the nurse practitioner’s registered nursing license an indication that the licensee is certified as a nurse practitioner and designate the nurse practitioner’s area of specialization.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall certify a nurse practitioner consistent with the nurse practitioner’s specialty, education, and national certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Nurse Practitioner — Scope and Standards of Practice."> <paragraph num="A."> <text>A nurse practitioner may independently perform the following functions:</text> <paragraph num="(1)"> <text>A comprehensive physical assessment of patients;</text> </paragraph> <paragraph num="(2)"> <text>In accordance with Family Law Article, §2-301, Annotated Code of Maryland, certify to the clerk of the court that a:</text> <paragraph num="(a)"> <text>16 or 17 year old individual, who wants to get married without parental consent, has been examined and found to be pregnant or has given birth to a child; or</text> </paragraph> <paragraph num="(b)"> <text>15 year old individual, who has parental consent to be married, has been examined and found to be pregnant or has given birth to a child;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In accordance with Transportation Article, §13-704, Annotated Code of Maryland, certify to the Department of Transportation that an individual needs special consideration for certain health reasons;</text> </paragraph> <paragraph num="(4)"> <text>In accordance with Health-General Article, §4-208, Annotated Code of Maryland, complete the date of birth and medical information required on a birth certificate;</text> </paragraph> <paragraph num="(5)"> <text>In accordance with Health-General Article, §4-212, Annotated Code of Maryland, complete a death certificate if:</text> <paragraph num="(a)"> <text>The medical examiner does not take charge of the body; and</text> </paragraph> <paragraph num="(b)"> <text>The deceased was under the care of the nurse practitioner;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Establish medical diagnosis for common short-term and chronic stable health problems;</text> </paragraph> <paragraph num="(7)"> <text>In accordance with Health-General Article, §4-212, Annotated Code of Maryland, file a replacement death certificate;</text> </paragraph> <paragraph num="(8)"> <text>In accordance with Health-General Article, §5-601, Annotated Code of Maryland, issue a do not resuscitate order on a Maryland Emergency Medical Services form.</text> </paragraph> <paragraph num="(9)"> <text>Order, perform, and interpret laboratory and diagnostic tests;</text> </paragraph> <paragraph num="(10)"> <text>Order and perform diagnostic, therapeutic, and corrective measures;</text> </paragraph> <paragraph num="(11)"> <text>Prescribe drugs;</text> </paragraph> <paragraph num="(12)"> <text>Provide emergency care;</text> </paragraph> <paragraph num="(13)"> <text>Refer patients to appropriate licensed physicians or other health care providers as needed;</text> </paragraph> <paragraph num="(14)"> <text>In accordance with COMAR 20.31.03.01, certify that the utility client has a serious illness or the need for life-support equipment; and</text> </paragraph> <paragraph num="(15)"> <text>In accordance with Health-General Article, §5-602, Annotated Code of Maryland, witness an advance directive.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A psychiatric nurse practitioner together with a physician is authorized to sign applications:</text> <paragraph num="(1)"> <text>In accordance with Health-General Article, §10-615, Annotated Code of Maryland, to admit a minor to a facility for treatment of a mental disorder; and</text> </paragraph> <paragraph num="(2)"> <text>In accordance with Health-General Article, §10-616, Annotated Code of Maryland, to admit an individual on an involuntary basis to a facility for treatment of a mental disorder.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A nurse practitioner may practice only in the area of specialization in which certified.</text> </paragraph> <paragraph num="D."> <text>Nothing in this chapter limits or prohibits a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law.</text> </paragraph> <paragraph num="E."> <text>A nurse practitioner has a right and obligation to refuse to perform any delegated act, oral or written, if in the nurse practitioner's judgment it is unsafe or an invalidly prescribed medical act.</text> </paragraph> <paragraph num="F."> <text>An individual certified under this chapter shall be subject to disciplinary sanctions set forth in Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>A nurse practitioner shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Renewal of Certification."> <paragraph num="A."> <text>A certification as a nurse practitioner expires at the same time as the nurse practitioner's registered nursing license.</text> </paragraph> <paragraph num="B."> <text>Before a nurse practitioner’s certification expires, the nurse practitioner may renew the certification biennially if the nurse practitioner:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>Documentation of every current national certification as a nurse practitioner from a national certifying body recognized by the Board that was the basis of the Board’s initial certification under Regulation .02B of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>A completed renewal application on the form that the Board requires; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certified nurse practitioner renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J—N.</text> </paragraph> <paragraph num="D."> <text>The certified nurse practitioner shall ensure that the Board has a record of each renewed national certification if any national certification expires before the registered nurse license renewal date.</text> </paragraph> <paragraph num="E."> <text>Certification as a nurse practitioner in an area of specialization shall be deemed to have lapsed if the Board does not have a record of the current active national certification in that area of specialization.</text> </paragraph> <paragraph num="F."> <text>Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Practice Before Maryland Certification."> <paragraph num="A."> <text>A registered nurse who has completed a Board-approved educational program for nurse practitioners and who has applied to take a Board-approved national certifying examination may practice as a nurse practitioner graduate before certification in this State upon approval of the Board if the nurse has:</text> <paragraph num="(1)"> <text>Submitted a completed application for certification as a nurse practitioner in this State in accordance with Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Completed a nurse practitioner education program approved by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Presented evidence of submission of an application to take a Board-approved national certification examination;</text> </paragraph> <paragraph num="(4)"> <text>Provided the name of a certified nurse practitioner, who has an active unencumbered Maryland license to practice as a registered nurse or a multistate privilege to practice registered nursing, who will directly supervise the nurse practitioner graduate; and</text> </paragraph> <paragraph num="(5)"> <text>Paid all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a certified nurse practitioner is not available in the graduate’s practice setting, as required in §A(4) of this regulation, a physician may provide this direct supervision if the nurse practitioner graduate provides the Board with the name of a certified nurse practitioner, who has an active unencumbered Maryland license to practice registered nursing or a multistate licensure privilege to practice registered nursing, with whom the nurse practitioner graduate has regular consultation.</text> </paragraph> <paragraph num="C."> <text>A nurse practitioner graduate who fails the Board-required examination shall immediately cease practice as a nurse practitioner graduate.</text> </paragraph> <paragraph num="D."> <text>An application for Maryland certification shall remain on file for a period of 18 months. During this time, applicants who have failed a national certifying examination may retake the examination and, upon proof of passing, may become eligible for Maryland certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Education."> <paragraph num="A."> <text>An applicant certified by a national certifying body before October 1, 2010, who is certified by the Board and in good standing shall be deemed to meet the education requirements under this regulation.</text> </paragraph> <paragraph num="B."> <text>An applicant for certification shall be a graduate from a Board-approved nationally accredited education program for nurse practitioners in a school of nursing that:</text> <paragraph num="(1)"> <text>Provides advanced practice instruction at the Masters’ level or higher in a clinical nursing program;</text> </paragraph> <paragraph num="(2)"> <text>Is accredited by a nursing accrediting body recognized by the United States Department of Education, the Council for Higher Education Accreditation or any other national accrediting body recognized by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Follows established educational standards that build upon educational preparation and experience as a registered nurse;</text> </paragraph> <paragraph num="(4)"> <text>Ensures completion of the advanced practice core, nurse practitioner core, and population specific core competencies;</text> </paragraph> <paragraph num="(5)"> <text>Has a didactic and clinical curriculum that, at a minimum, includes advanced courses in:</text> <paragraph num="(a)"> <text>Physiology and pathophysiology;</text> </paragraph> <paragraph num="(b)"> <text>Physical and health assessment;</text> </paragraph> <paragraph num="(c)"> <text>Pharmacology; and</text> </paragraph> <paragraph num="(d)"> <text>Diagnosis and management of health problems and diseases commonly encountered within the respective nurse practitioner’s population focus;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provides didactic courses and supervised clinical experiences of sufficient depth and breadth in the nurse practitioner role and the specific population focus of the program; and</text> </paragraph> <paragraph num="(7)"> <text>Ensures that graduates of the program are eligible for national certification and Maryland certification.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To be a Board-approved education program the program shall:</text> <paragraph num="(1)"> <text>Be a nationally accredited education program; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure ongoing competence and maintenance of certification by:</text> <paragraph num="(a)"> <text>Providing a mechanism for renewing certification;</text> </paragraph> <paragraph num="(b)"> <text>Having a renewal of certification process that is acceptable to the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Developing a mutually agreeable procedure that ensures communication with the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Preparing and Dispensing."> <paragraph num="A."> <text>A nurse practitioner may personally prepare and dispense any drug that a nurse practitioner is authorized to prescribe in the course of treating a patient at:</text> <paragraph num="(1)"> <text>A medical facility or clinic that specializes in the treatment of medical cases reimbursable through workers' compensation insurance;</text> </paragraph> <paragraph num="(2)"> <text>A medical facility or clinic that is operated on a nonprofit basis;</text> </paragraph> <paragraph num="(3)"> <text>A health center that operates on a campus of an institution of higher education;</text> </paragraph> <paragraph num="(4)"> <text>A public health facility, a medical facility under contract with a State or local health department, or a facility funded with public funds; or</text> </paragraph> <paragraph num="(5)"> <text>A nonprofit hospital or a nonprofit hospital out-patient facility as authorized under the policies established by the hospital.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse practitioner who personally prepares and dispenses a drug in the course of treating a patient shall:</text> <paragraph num="(1)"> <text>Comply with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Record the dispensing of the prescription drug on the patient's chart;</text> </paragraph> <paragraph num="(3)"> <text>Allow the Division of Drug Control to enter and inspect the nurse practitioner's office at all reasonable hours;</text> </paragraph> <paragraph num="(4)"> <text>Except for starter dosages or samples dispensed without charge, provide the patient with a written prescription; and</text> </paragraph> <paragraph num="(5)"> <text>Stamp all Schedule III, IV, and V prescriptions with the letter “C” in red ink, not less than 1 inch high in the lower right hand corner.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A nurse practitioner shall:</text> <paragraph num="(1)"> <text>Maintain two separate files, one for Schedule II prescriptions and another file for all other prescriptions; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain all prescription files for 7 years.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A nurse practitioner may personally prepare and dispense a starter dosage of any drug the nurse practitioner is authorized to prescribe. The nurse practitioner shall:</text> <paragraph num="(1)"> <text>Label the starter dosage in compliance with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Provide the starter dose free of charge; and</text> </paragraph> <paragraph num="(3)"> <text>Enter the starter dose dispensed in the patient's medical record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Unlawful Practices."> <text>Unless authorized to practice as a nurse practitioner under Health Occupations Article, Title 8, Annotated Code of Maryland, an individual may not:</text> <paragraph num="A."> <text>Represent to the public by title or by description of services, methods, procedures, or otherwise, that the individual is authorized to practice as a nurse practitioner in this State;</text> </paragraph> <paragraph num="B."> <text>Use as a title or describe the services the individual provides by use of the words “nurse practitioner” or “certified nurse practitioner”; or</text> </paragraph> <paragraph num="C."> <text>Use the abbreviation “NP”, “CRNP”, “CNP”, or any other words, letters, or symbols with the intent to represent that the individual practices as a nurse practitioner.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Family Law Article, §2-301; Health-General Article, §§4-208(a), 4-212, §4-403, 5-601(c)—(e), 5-608(c), 10-616, 10-628, 13-701, and 13-704; Health Occupations Article, §§8-205(a)(1), (2), (4), and (5), and 8-302; Transportation Article, §§13-616(a) and (b), Annotated Code of Maryland; Ch. 342, Acts of 2015; Ch. 468, Acts of 2015</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 6, 1981 (8:5 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 29, 1994 (21:17 Md. R. 1439)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 7, 1993 (20:11 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 7, 1993 (20:11 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 7, 1993 (20:11 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective June 7, 1993 (20:11 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective August 29, 1994 (21:17 Md. R. 1439)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 11, 2011 (38:14 Md. R. 790)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 10, 2015 (42:24 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G adopted effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="08" heading="Petition for Declaratory Ruling"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Person” means an individual, an agency, an association, a corporation, or any other entity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Petition."> <paragraph num="A."> <text>An interested person may file with the Board a petition for a declaratory ruling with respect to the manner in which the Board would apply:</text> <paragraph num="(1)"> <text>A statute;</text> </paragraph> <paragraph num="(2)"> <text>A regulation; or</text> </paragraph> <paragraph num="(3)"> <text>An order which the Board enforces to a particular case based on the facts presented in the petition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may delegate responsibility for consideration of the petition.</text> </paragraph> <paragraph num="C."> <text>Petition for Declaratory Ruling.</text> <paragraph num="(1)"> <text>The petition for a declaratory ruling shall be filed in writing.</text> </paragraph> <paragraph num="(2)"> <text>The petition shall contain a statement describing in detail: interest of the petitioner in making:</text> <paragraph num="(a)"> <text>The interest of the petitioner in making the request;</text> </paragraph> <paragraph num="(b)"> <text>The issue involved;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the facts; and</text> </paragraph> <paragraph num="(d)"> <text>A list of relevant documents or statements, or both, to be considered.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may require an affidavit from the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Granting of Petition.</text> <paragraph num="(1)"> <text>Not later than 60 days from receipt of the petition the Board shall inform the petitioner whether the petition will be considered.</text> </paragraph> <paragraph num="(2)"> <text>If the Board decides not to consider the petition, the Board shall inform the petitioner in writing of the reasons for denial.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Consideration and Disposition."> <paragraph num="A."> <text>In rendering its ruling the Board or its designee:</text> <paragraph num="(1)"> <text>Shall consider all materials submitted with the petition;</text> </paragraph> <paragraph num="(2)"> <text>May consider any document, data, or other relevant material;</text> </paragraph> <paragraph num="(3)"> <text>May consult individuals;</text> </paragraph> <paragraph num="(4)"> <text>May consider comments from the staff; or</text> </paragraph> <paragraph num="(5)"> <text>May require argument of the question or permit the introduction of evidence.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposition.</text> <paragraph num="(1)"> <text>A declaratory ruling issued shall be in writing, stating the:</text> <paragraph num="(a)"> <text>Question;</text> </paragraph> <paragraph num="(b)"> <text>Decision;</text> </paragraph> <paragraph num="(c)"> <text>Description of factors considered; and</text> </paragraph> <paragraph num="(d)"> <text>Sources relied upon.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A declaratory ruling issued by the Board shall plainly state that it is a declaratory ruling pursuant to these regulations.</text> </paragraph> <paragraph num="(3)"> <text>A written answer from the Board or any employee of the Board to an inquiry may not be construed as a declaratory ruling unless made in conformity with these regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Publication and Inspection.</text> <paragraph num="(1)"> <text>The Board shall keep a record of each declaratory ruling issued.</text> </paragraph> <paragraph num="(2)"> <text>The Board may publish declaratory rulings of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may refuse to consider a petition if the:</text> <paragraph num="(1)"> <text>Request contains incomplete information upon which to base an informed declaratory ruling;</text> </paragraph> <paragraph num="(2)"> <text>Board or its designee concludes that a declaratory ruling cannot reasonably be given on the matter;</text> </paragraph> <paragraph num="(3)"> <text>Matter is adequately covered by a prior:</text> <paragraph num="(a)"> <text>Regulation;</text> </paragraph> <paragraph num="(b)"> <text>Declaratory ruling;</text> </paragraph> <paragraph num="(c)"> <text>Decision;</text> </paragraph> <paragraph num="(d)"> <text>Legal opinion; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board or its designee concludes that a ruling would not be in the public interest.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Effect, Revision, and Appeal."> <paragraph num="A."> <text>Effect. A declaratory ruling shall be binding upon the Board and the petitioner on the statement of facts covered in the declaratory ruling and set forth in the petition.</text> </paragraph> <paragraph num="B."> <text>Revision.</text> <paragraph num="(1)"> <text>The petitioner's application for revision of the declaratory ruling shall:</text> <paragraph num="(a)"> <text>Be filed within 10 days after the issuance of the declaratory ruling; and</text> </paragraph> <paragraph num="(b)"> <text>State the grounds for the revision;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon receipt of the application, the Board may:</text> <paragraph num="(a)"> <text>Open the declaratory ruling to receive additional information;</text> </paragraph> <paragraph num="(b)"> <text>Amend its ruling or its statement or reasons for the ruling;</text> </paragraph> <paragraph num="(c)"> <text>Set forth additional findings or reasons;</text> </paragraph> <paragraph num="(d)"> <text>Enter new findings, new reasons, or a new ruling.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board shall grant or deny the application within 90 days of its submission.</text> </paragraph> <paragraph num="(4)"> <text>The Board may exercise revisory power and control over the declaratory ruling in the case of fraud, mistake, or irregularity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">State Government Article, §§10-301 — 10-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 22, 1988 (15:4 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> </annotations> </chapter> <chapter num="09" heading="Standards of Practice for Registered Nurses"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accountability” means being answerable for the actions of self and others.</text> </paragraph> <paragraph num="(2)"> <text>“Aggregate” means the sum total of nursing care the client received.</text> </paragraph> <paragraph num="(3)"> <text>“Assessment” means a systematic, dynamic process by which the nurse, through interaction with the client, family, significant others, and other health care providers, collects and analyzes data.</text> </paragraph> <paragraph num="(4)"> <text>“Assign” means the transfer of responsibility from one nurse to another with each nurse having the legal authority to perform the function as permitted by the licensee's scope of practice.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means an individual, family, group, or community under the licensee's direct or indirect care.</text> </paragraph> <paragraph num="(6)"> <text>“Continuity of care” means an interdisciplinary process that:</text> <paragraph num="(a)"> <text>Includes the client, family, and significant other in the development and communication of a coordinated plan of care; and</text> </paragraph> <paragraph num="(b)"> <text>Based on changing needs and available resources, facilitates the client's:</text> <paragraph num="(i)"> <text>Care within a setting, and</text> </paragraph> <paragraph num="(ii)"> <text>Transition between settings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Criteria” means relevant, measurable indicators of the standards of registered nurse practice.</text> </paragraph> <paragraph num="(8)"> <text>“Delegate” means the registered nurse:</text> <paragraph num="(a)"> <text>Invests authority to act on behalf of the registered nurse to an unlicensed person;</text> </paragraph> <paragraph num="(b)"> <text>Authorizes the unlicensed person to augment and supplement the care the registered nurse provides; and</text> </paragraph> <paragraph num="(c)"> <text>Retains the accountability and responsibility for the delegated act.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Evaluation” means the review and analysis of the extent to which the assessment, nursing diagnosis, planning, and implementation is effective in resolving the client's health problems or progress toward the attainment of expected outcomes.</text> </paragraph> <paragraph num="(10)"> <text>Health Care Providers.</text> <paragraph num="(a)"> <text>“Health care provider” means an individual with special expertise who provides health care services or assistance to clients.</text> </paragraph> <paragraph num="(b)"> <text>“Health care provider” includes:</text> <paragraph num="(i)"> <text>Nurses;</text> </paragraph> <paragraph num="(ii)"> <text>Physicians;</text> </paragraph> <paragraph num="(iii)"> <text>Psychologists;</text> </paragraph> <paragraph num="(iv)"> <text>Social workers;</text> </paragraph> <paragraph num="(v)"> <text>Nutritionists/dietitians; and</text> </paragraph> <paragraph num="(vi)"> <text>Various therapists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Health care team” means a group of individuals, which includes health care providers and unlicensed personnel, working in collaboration with the client, family, and significant others to achieve identified outcomes.</text> </paragraph> <paragraph num="(12)"> <text>Health Status Data.</text> <paragraph num="(a)"> <text>“Health status data” means information obtained through nursing assessment of the client.</text> </paragraph> <paragraph num="(b)"> <text>“Health status data” includes but is not limited to:</text> <paragraph num="(i)"> <text>Growth and development;</text> </paragraph> <paragraph num="(ii)"> <text>Biophysical status;</text> </paragraph> <paragraph num="(iii)"> <text>Emotional status;</text> </paragraph> <paragraph num="(iv)"> <text>Cultural, religious, and socioeconomic background;</text> </paragraph> <paragraph num="(v)"> <text>Activities of daily living and instrumental activities of daily living;</text> </paragraph> <paragraph num="(vi)"> <text>Patterns of coping;</text> </paragraph> <paragraph num="(vii)"> <text>Interaction patterns;</text> </paragraph> <paragraph num="(viii)"> <text>Client perception of and degree of satisfaction with health status;</text> </paragraph> <paragraph num="(ix)"> <text>Client health goals;</text> </paragraph> <paragraph num="(x)"> <text>Physical, social, emotional, and ecological environments; and</text> </paragraph> <paragraph num="(xi)"> <text>Access to and availability of human and material resources.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Implementation” means the process of performing, delegating, assigning, supervising, and coordinating interventions.</text> </paragraph> <paragraph num="(14)"> <text>“Instrumental activities of daily living” means home management skills such as shopping for food and personal items, preparing meals, or handling money.</text> </paragraph> <paragraph num="(15)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(16)"> <text>“Nursing diagnosis” means a description of the actual or potential, overt or covert health problems which registered nurses are licensed to treat.</text> </paragraph> <paragraph num="(17)"> <text>“Outcomes” means measurable, expected, client-focused goals which translate into observable behaviors.</text> </paragraph> <paragraph num="(18)"> <text>“Plan of care” means designing methods to solve identified problems and to attain outcomes by means of establishing priorities, setting goals, and defining interventions.</text> </paragraph> <paragraph num="(19)"> <text>“Process” means the delivery of care and the fulfillment of the practice standards.</text> </paragraph> <paragraph num="(20)"> <text>“Quality of care” means the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.</text> </paragraph> <paragraph num="(21)"> <text>“Recipients of nursing care” means individuals, families, groups, communities, or populations.</text> </paragraph> <paragraph num="(22)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Responsibility” means the obligation and duty to perform.</text> </paragraph> <paragraph num="(24)"> <text>“Scientific principles” means a fundamental belief or reason for action derived from an organized system of study.</text> </paragraph> <paragraph num="(25)"> <text>“Standards of care” means a minimum level of competent nursing practice demonstrated through assessment, analysis, formulation of nursing diagnosis, outcome identification, planning, implementation, and evaluation.</text> </paragraph> <paragraph num="(26)"> <text>Standards of Registered Nurse Practice.</text> <paragraph num="(a)"> <text>“Standards of registered nurse practice” means the minimum criteria the registered nurse shall adhere to in the practice of registered nursing.</text> </paragraph> <paragraph num="(b)"> <text>“Standards of registered nurse practice” includes both standards of care and standards of professional performance.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>Standards of Professional Performance.</text> <paragraph num="(a)"> <text>“Standards of professional performance” means a competent level of behavior in the professional role.</text> </paragraph> <paragraph num="(b)"> <text>“Standards of professional performance” includes activities related to:</text> <paragraph num="(i)"> <text>Quality of care;</text> </paragraph> <paragraph num="(ii)"> <text>Performance appraisal;</text> </paragraph> <paragraph num="(iii)"> <text>Education;</text> </paragraph> <paragraph num="(iv)"> <text>Collegiality;</text> </paragraph> <paragraph num="(v)"> <text>Ethics;</text> </paragraph> <paragraph num="(vi)"> <text>Collaboration;</text> </paragraph> <paragraph num="(vii)"> <text>Research;</text> </paragraph> <paragraph num="(viii)"> <text>Resource utilization;</text> </paragraph> <paragraph num="(ix)"> <text>Assignment;</text> </paragraph> <paragraph num="(x)"> <text>Delegation and supervision; and</text> </paragraph> <paragraph num="(xi)"> <text>Refusal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Structure” means:</text> <paragraph num="(a)"> <text>The environment in which care is provided; and</text> </paragraph> <paragraph num="(b)"> <text>Resources available to provide care including but not limited to finances, staffing, supplies, equipment, and medical records.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Technology assessment” means a review of drugs, devices, procedures, and systems in relationship to their safety, effectiveness, and economic and social impact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Standards of Care."> <paragraph num="A."> <text>Assessment.</text> <paragraph num="(1)"> <text>The RN shall collect client health data.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>Data collection shall involve the client, family, significant others, other members of the health care team, and the health record, when appropriate.</text> </paragraph> <paragraph num="(b)"> <text>Data may include the following dimensions:</text> <paragraph num="(i)"> <text>Physical;</text> </paragraph> <paragraph num="(ii)"> <text>Psychological;</text> </paragraph> <paragraph num="(iii)"> <text>Sociocultural;</text> </paragraph> <paragraph num="(iv)"> <text>Spiritual;</text> </paragraph> <paragraph num="(v)"> <text>Cognitive;</text> </paragraph> <paragraph num="(vi)"> <text>Functional abilities;</text> </paragraph> <paragraph num="(vii)"> <text>Developmental;</text> </paragraph> <paragraph num="(viii)"> <text>Economic;</text> </paragraph> <paragraph num="(ix)"> <text>Technology; and</text> </paragraph> <paragraph num="(x)"> <text>Life-style.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Priority of data collection is determined by the client's immediate condition or needs, health status, and setting.</text> </paragraph> <paragraph num="(4)"> <text>Pertinent data shall be collected using appropriate assessment techniques.</text> </paragraph> <paragraph num="(5)"> <text>Data collection shall include a technology assessment.</text> </paragraph> <paragraph num="(6)"> <text>The data collection process shall be comprehensive, systematic, and ongoing.</text> </paragraph> <paragraph num="(7)"> <text>Relevant health status data, including changes, shall be documented in an authorized record which is accessible and in a retrievable form.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Analysis and Nursing Diagnosis.</text> <paragraph num="(1)"> <text>The RN shall analyze the assessment data in determining nursing diagnoses.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The RN shall analyze the data, consider the options, including technology, and make a determination as to whether the selected options are appropriate for the needs of the client.</text> </paragraph> <paragraph num="(b)"> <text>Nursing diagnoses shall be:</text> <paragraph num="(i)"> <text>Derived in a complete, systematic, and ongoing manner from the assessment data;</text> </paragraph> <paragraph num="(ii)"> <text>Validated with the client, family, significant others, and other members of the health care team, when possible; and</text> </paragraph> <paragraph num="(iii)"> <text>Documented in a manner that facilitates the determination of expected outcomes and plan of care.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Nursing diagnoses shall identify the nature and extent of the client's health status, capabilities, and limitations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Outcome Identification.</text> <paragraph num="(1)"> <text>The RN shall identify expected outcomes individualized to the client.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>Outcomes shall be:</text> <paragraph num="(i)"> <text>Derived in a comprehensive, systematic, and ongoing manner from the diagnoses;</text> </paragraph> <paragraph num="(ii)"> <text>Directed toward management of the client's health problems;</text> </paragraph> <paragraph num="(iii)"> <text>Formulated with the client, family, significant other, or other members of the health care team, when possible and appropriate;</text> </paragraph> <paragraph num="(iv)"> <text>Culturally appropriate and realistic in relation to the client's present and potential capabilities;</text> </paragraph> <paragraph num="(v)"> <text>Attainable in relation to the resources available to the client;</text> </paragraph> <paragraph num="(vi)"> <text>Documented as measurable goals with time estimates for attainment as appropriate; and</text> </paragraph> <paragraph num="(vii)"> <text>Documented in an authorized record which is accessible and in a retrievable form.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Outcomes provide direction for continuity of care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Planning.</text> <paragraph num="(1)"> <text>The RN shall develop a plan of care that prescribes interventions to attain expected outcomes.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The plan shall be:</text> <paragraph num="(i)"> <text>Individualized in a comprehensive, systematic and ongoing manner;</text> </paragraph> <paragraph num="(ii)"> <text>Developed utilizing available data;</text> </paragraph> <paragraph num="(iii)"> <text>Prioritized to meet the client's condition or needs;</text> </paragraph> <paragraph num="(iv)"> <text>Developed, coordinated, and communicated with the client, family, significant other, and other members of the health care team as appropriate;</text> </paragraph> <paragraph num="(v)"> <text>Congruent with the client's therapeutic regime; and</text> </paragraph> <paragraph num="(vi)"> <text>Documented.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The plan shall:</text> <paragraph num="(i)"> <text>Reflect current nursing practice;</text> </paragraph> <paragraph num="(ii)"> <text>Provide for continuity of care; and</text> </paragraph> <paragraph num="(iii)"> <text>Include identification, coordination, and utilization of available resources.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Implementation.</text> <paragraph num="(1)"> <text>The RN shall implement the interventions identified in the plan of care.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>Interventions shall be:</text> <paragraph num="(i)"> <text>Implemented recognizing the rights of the client, the family, and significant others;</text> </paragraph> <paragraph num="(ii)"> <text>Consistent with the established plan of care;</text> </paragraph> <paragraph num="(iii)"> <text>Implemented in a competent, safe, and appropriate manner consistent with knowledge of scientific principles; and</text> </paragraph> <paragraph num="(iv)"> <text>Documented.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Interventions may include, but are not limited to:</text> <paragraph num="(i)"> <text>Patient teaching;</text> </paragraph> <paragraph num="(ii)"> <text>Counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Implementing clinical practice guidelines, protocols, and pathways; and</text> </paragraph> <paragraph num="(iv)"> <text>Independent nursing functions.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Selected interventions may be assigned and delegated to other personnel participating in delivering care.</text> </paragraph> <paragraph num="(d)"> <text>When assignment or delegation occurs, supervision is provided.</text> </paragraph> <paragraph num="(e)"> <text>A safe and therapeutic environment is provided for the delivery of nursing care.</text> </paragraph> <paragraph num="(f)"> <text>Relevant information which may be needed to carry out the nursing plan is provided to the client, family, significant others, and other members of the health care team without violating the client's confidentiality.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Evaluation.</text> <paragraph num="(1)"> <text>The RN shall evaluate the client's progress toward attainment of outcomes.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>Evaluation shall be systematic, ongoing, and criterion-based.</text> </paragraph> <paragraph num="(b)"> <text>The client, family, significant other, and other members of the health care team shall be involved in the evaluation process, when appropriate.</text> </paragraph> <paragraph num="(c)"> <text>Ongoing assessment data shall be used to evaluate the process of care and to revise the nursing diagnosis, outcomes, and the plan of care.</text> </paragraph> <paragraph num="(d)"> <text>Revisions of diagnoses, outcomes, and the plan of care shall be documented.</text> </paragraph> <paragraph num="(e)"> <text>The effectiveness of interventions shall be evaluated in relation to outcomes.</text> </paragraph> <paragraph num="(f)"> <text>The responses to interventions shall be documented and communicated to the client and other members of the health care team.</text> </paragraph> <paragraph num="(g)"> <text>The RN charged with the documentation of the client's discharge shall make the final nursing evaluation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Documentation. The RN shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Professional Performance."> <paragraph num="A."> <text>Quality of Care.</text> <paragraph num="(1)"> <text>The RN systematically shall evaluate the quality and effectiveness of nursing practice in the aggregate.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN shall:</text> <paragraph num="(a)"> <text>Participate in activities to evaluate quality of care including, but not limited to, monitoring the structure, process, and outcome of nursing practice, with consideration for access and cost;</text> </paragraph> <paragraph num="(b)"> <text>Use quality monitoring data to identify opportunities for improving care; and</text> </paragraph> <paragraph num="(c)"> <text>Participate in activities related to implementing changes designed to improve care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Performance Appraisal.</text> <paragraph num="(1)"> <text>The RN shall be accountable for evaluating the RN's own nursing practice on a regular basis in relation to professional practice standards and relevant statutes and regulations.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The RN shall:</text> <paragraph num="(i)"> <text>Participate in peer review as appropriate; and</text> </paragraph> <paragraph num="(ii)"> <text>Seek guidance, support, education, and supervision as necessary.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The RN shall demonstrate knowledge of and shall comply with:</text> <paragraph num="(i)"> <text>Relevant professional practice standards;</text> </paragraph> <paragraph num="(ii)"> <text>Statutes and regulations governing nursing; and</text> </paragraph> <paragraph num="(iii)"> <text>The policies and procedures of the practice setting.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Education.</text> <paragraph num="(1)"> <text>The RN shall acquire and maintain current knowledge and competency in nursing practice.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN shall:</text> <paragraph num="(a)"> <text>Participate in educational opportunities and experiences to maintain professional competence; and</text> </paragraph> <paragraph num="(b)"> <text>Obtain knowledge and skills appropriate to the practice setting.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Collegiality.</text> <paragraph num="(1)"> <text>The RN shall contribute to the professional development of peers, colleagues, and others.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The RN shall share knowledge and skills with peers, colleagues, and others.</text> </paragraph> <paragraph num="(b)"> <text>The RN shall contribute to a supportive and healthy work environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Ethics.</text> <paragraph num="(1)"> <text>The RN's decisions and actions shall reflect ethical principles.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN shall:</text> <paragraph num="(a)"> <text>Comply with the Code of Ethics in COMAR 10.27.19;</text> </paragraph> <paragraph num="(b)"> <text>Maintain client confidentiality within legal and regulatory standards;</text> </paragraph> <paragraph num="(c)"> <text>Act as a client advocate and assist clients to advocate for themselves;</text> </paragraph> <paragraph num="(d)"> <text>Deliver care in a nonjudgmental and nondiscriminatory manner that is sensitive to client diversity;</text> </paragraph> <paragraph num="(e)"> <text>Deliver care in a manner that preserves client autonomy, dignity, and rights; and</text> </paragraph> <paragraph num="(f)"> <text>Seek available resources to help formulate ethical decisions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Collaboration.</text> <paragraph num="(1)"> <text>The RN shall collaborate with the client, family, significant others, and other health care providers in providing care.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN shall:</text> <paragraph num="(a)"> <text>Collaborate with the client, family, significant others, and other health care providers in the formulation of overall goals, the plan of care, and decisions related to care and the delivery of services; and</text> </paragraph> <paragraph num="(b)"> <text>Consult with health care providers for client care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Research.</text> <paragraph num="(1)"> <text>The RN shall participate in research activities appropriate to the licensee's position, education, and practice environment.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN shall:</text> <paragraph num="(a)"> <text>Support the client's rights related to research;</text> </paragraph> <paragraph num="(b)"> <text>Participate in data collection;</text> </paragraph> <paragraph num="(c)"> <text>Participate in identification of clinical problems suitable for nursing research; and</text> </paragraph> <paragraph num="(d)"> <text>Utilize established facility-approved research protocols.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Resource Utilization.</text> <paragraph num="(1)"> <text>The RN shall consider factors related to safety, effectiveness, and cost in planning and delivering client care.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The RN:</text> <paragraph num="(a)"> <text>Shall assist the client, family, and significant others in identifying services and options available to address health-related needs;</text> </paragraph> <paragraph num="(b)"> <text>Shall evaluate factors related to safety, effectiveness, and cost when performing, assigning, delegating, and supervising nursing care, and teaching the client, family, and significant others; and</text> </paragraph> <paragraph num="(c)"> <text>As a case manager, may identify and facilitate options and services for meeting individual health needs by enhancing quality, cost-effective clinical outcomes while decreasing fragmentation and duplication of care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Assignment, Delegation, and Supervision.</text> <paragraph num="(1)"> <text>The RN may assign nursing acts or delegate nursing tasks to individuals who are competent to perform those acts or tasks, when the assignment or delegation does not jeopardize the client's welfare.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>When delegating a nursing task to an unlicensed person, the RN shall assess the client and determine that the delegation is consistent with COMAR 10.27.11.</text> </paragraph> <paragraph num="(b)"> <text>When delegating a nursing task to an unlicensed person, the registered nurse shall:</text> <paragraph num="(i)"> <text>Instruct;</text> </paragraph> <paragraph num="(ii)"> <text>Direct;</text> </paragraph> <paragraph num="(iii)"> <text>Regularly evaluate the performance of nursing tasks by the unlicensed person;</text> </paragraph> <paragraph num="(iv)"> <text>Rectify a situation in which the unlicensed person under the licensee's supervision is performing nursing tasks incorrectly; and</text> </paragraph> <paragraph num="(v)"> <text>Prohibit the continued performance of an unlicensed person who is performing the delegated nursing task or tasks incompetently.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>When the RN is assigning a nursing act to another licensed nurse, the RN shall:</text> <paragraph num="(i)"> <text>Verify that the nursing act is within the licensed nurse's legal scope of practice;</text> </paragraph> <paragraph num="(ii)"> <text>Verify that the licensed nurse has the knowledge, skills and clinical competency to perform the assigned act;</text> </paragraph> <paragraph num="(iii)"> <text>Verify that the assigned act is consistent with the facility's policies and procedures;</text> </paragraph> <paragraph num="(iv)"> <text>Regularly evaluate the licensed nurse who is performing the assigned nursing act;</text> </paragraph> <paragraph num="(v)"> <text>Rectify a situation in which the licensed nurse assigned to perform the nursing act has performed the nursing act incorrectly; and</text> </paragraph> <paragraph num="(vi)"> <text>Prohibit the continued performance of the assigned nursing act by a licensed nurse who is performing the assigned nursing act or acts incompetently.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Refusal.</text> <paragraph num="(1)"> <text>The RN has the right and the responsibility to refuse to perform, assign, or delegate nursing acts.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The RN has the right and responsibility to refuse to perform a nursing act which is beyond the parameters of the nurse's education, capabilities, and clinical competency.</text> </paragraph> <paragraph num="(b)"> <text>The RN shall obtain appropriate education, training, and supervision as required to perform nursing functions which are beyond the parameters of the nurse's education and clinical competence.</text> </paragraph> <paragraph num="(c)"> <text>The RN has the right to refuse to accept responsibility and accountability for supervising, monitoring, instructing, or evaluating an unlicensed person performing a nursing task that has not been delegated by that nurse.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Specialty Practice."> <paragraph num="A."> <text>A registered nurse functioning in a specialty practice shall have additional education, training, and experience. Specialty practice does not include advanced practice nursing.</text> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Critically ill client” means a client who:</text> <paragraph num="(i)"> <text>Has developed or is at high risk for developing life threatening problems;</text> </paragraph> <paragraph num="(ii)"> <text>Requires constant intensive multidisciplinary assessment and intervention to restore stability and prevent complications; and</text> </paragraph> <paragraph num="(iii)"> <text>Needs restoration or maintenance of physiologic stability.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Interfacility specialty care transport” means the movement of a critically ill client by transport vehicle when the client’s level of care requires the care of a registered nurse during transport.</text> </paragraph> <paragraph num="(c)"> <text>On-Line Medical Direction.</text> <paragraph num="(i)"> <text>“On-line medical direction” means oversight and orders by licensed physicians at base stations to EMS providers or members of the transport team providing patient care at an Advanced Life Support (ALS) or Basic Life Support (BLS) level.</text> </paragraph> <paragraph num="(ii)"> <text>“On-line medical direction” includes medical orders and oversight by a licensed practitioner at a specialty care unit at a hospital to a registered nurse during a specialty care transport, provided the licensed practitioner is permitted by the facility to provide these services and the services are within the scope of the individual’s license.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Licensed Practitioner.</text> <paragraph num="(i)"> <text>“Licensed practitioner” means a dentist, physician, nurse practitioner, nurse anesthetist, or nurse midwife or any other individual permitted by law and the facility to provide care and services within the scope of the individual’s license.</text> </paragraph> <paragraph num="(ii)"> <text>“Licensed practitioner” does not include a student in a graduate education program whose practice requires supervision and whose orders must be countersigned.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>“Specialty care transport” means transport for all ages of critically ill clients in accordance with the definitions under COMAR 30.09.01.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Practice Specialty Care Transport.</text> <paragraph num="(1)"> <text>Education, Training, and Experience Requirements. Except for the provisions under §C(2) and (4) of this regulation, a registered nurse who provides interfacility specialty care transport shall meet the education, training, and experience requirements for staffing an interfacility specialty care transport mission in accordance with COMAR 30.09.14.02G(1)—(3).</text> </paragraph> <paragraph num="(2)"> <text>When a specialty care transport ambulance is not available within a clinically reasonable time, a registered nurse who has not completed a program of study in accordance with COMAR 30.09.14.02G(1)—(3) for the transport of patients by ambulance can provide interfacility specialty care, if:</text> <paragraph num="(a)"> <text>The registered nurse has education, training, and experience in the critical care area required by the mission as determined by the referring physician;</text> </paragraph> <paragraph num="(b)"> <text>The registered nurse is accompanied by an individual who is currently licensed as a Maryland ALS provider, in accordance with COMAR 30.02.02, to support the registered nurse with the transport; and</text> </paragraph> <paragraph num="(c)"> <text>On-line medical direction is available to the registered nurse.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A registered nurse providing specialty care transport who does not have national certification for working with the client population to be transported shall have at least:</text> <paragraph num="(a)"> <text>2 years of clinical nursing experience in critical or specialty care within the last 5 years;</text> </paragraph> <paragraph num="(b)"> <text>Age appropriate advanced life support training; and</text> </paragraph> <paragraph num="(c)"> <text>Nursing expertise in the specialty care area required by the client’s age and diagnosis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>This regulation does not apply to, restrict, or limit:</text> <paragraph num="(a)"> <text>Other health care practitioners who are authorized to perform these duties under their respective laws; or</text> </paragraph> <paragraph num="(b)"> <text>A registered nurse providing care to a critically ill patient during a declared natural disaster or emergency.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A registered nurse is prohibited from accepting a transport assignment that exceeds the nurse’s knowledge and expertise.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §§8-205 and 8-316, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 20, 1989 (16:3 Md. R. 343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 25, 1993 (20:21 Md. R. 1654)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.03 adopted effective April 3, 2000 (27:6 Md. R. 642)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G adopted effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective March 17, 2014 (41:5 Md. R. 346)</annotation> </annotations> </chapter> <chapter num="10" heading="Standards of Practice for Licensed Practical Nurses"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assessment” means the act of gathering and identifying data about the client.</text> </paragraph> <paragraph num="(2)"> <text>“Assign” means the transfer of responsibility from one nurse to another, each having legal authority to perform the function as permitted by the licensee’s scope of practice.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Case management” means a collaborative process that assesses, plans, implements, coordinates, monitors, and evaluates options and services to meet the client’s health needs through enhanced communication and use of available resources to promote quality client outcomes and cost effective care.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means an individual who is under the licensee’s direct or indirect care.</text> </paragraph> <paragraph num="(6)"> <text>Comprehensive Nursing Assessment.</text> <paragraph num="(a)"> <text>“Comprehensive nursing assessment” means an assessment performed by a registered nurse which is the foundation for the analysis of the assessment data to determine:</text> <paragraph num="(i)"> <text>The nursing diagnosis;</text> </paragraph> <paragraph num="(ii)"> <text>Expected client outcomes; and</text> </paragraph> <paragraph num="(iii)"> <text>The client’s plan of care.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Comprehensive nursing assessment” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Extensive initial and ongoing data collection for individuals, families, groups, and communities;</text> </paragraph> <paragraph num="(ii)"> <text>A focused nursing assessment;</text> </paragraph> <paragraph num="(iii)"> <text>Past history, current health status, and potential changes in the client’s condition;</text> </paragraph> <paragraph num="(iv)"> <text>Identification of alterations to the client’s previous condition; and</text> </paragraph> <paragraph num="(v)"> <text>Synthesis of the biological, psychological, spiritual, and social aspects of the client’s condition.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Contributes” means to participate as a team member in the nursing team relationship.</text> </paragraph> <paragraph num="(8)"> <text>“Delegating” means the act of authorizing an unlicensed individual, a certified nursing assistant, or a certified medication technician to perform selected acts of registered nursing or licensed practical nursing.</text> </paragraph> <paragraph num="(9)"> <text>“Evaluation” means the review and analysis of the extent to which the assessment, planning, and implementation were effective in resolving the client’s health problem.</text> </paragraph> <paragraph num="(10)"> <text>Focused nursing assessment.</text> <paragraph num="(a)"> <text>“Focused nursing assessment” means an appraisal of a client’s current health status and situation at hand;</text> </paragraph> <paragraph num="(b)"> <text>“Focused nursing assessment” includes the reporting of information to other members of the health care team.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Goal” means a measurable result to be achieved by a client which is either long- or short-term.</text> </paragraph> <paragraph num="(12)"> <text>“Implementation” means the carrying out of the nursing plan of care.</text> </paragraph> <paragraph num="(13)"> <text>“Licensed nurse” means a licensed practical nurse or registered nurse.</text> </paragraph> <paragraph num="(14)"> <text>“Licensed practical nurse (LPN)” means an individual who is licensed by the Board to practice licensed practical nursing or holds a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> <paragraph num="(15)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(16)"> <text>“Nursing plan of care” means an established set of goals, priorities, and methods designed to solve, prevent, and manage a client’s identified problems.</text> </paragraph> <paragraph num="(17)"> <text>“Nursing team relationship” means that each licensed or certified individual who participates in providing care for a client is a part of the nursing team.</text> </paragraph> <paragraph num="(18)"> <text>“ Nursing triage” means the systematic collection of client data at the client’s point of entry or re-entry into the health care system for the purpose of sorting clients by acuity levels to determine the allocation of available health care resources to direct each client to the right health care provider at the right time.</text> </paragraph> <paragraph num="(19)"> <text>“Record” means a written retrievable document containing the client’s health information.</text> </paragraph> <paragraph num="(20)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Who holds a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>Standards of Licensed Practical Nurse Practice.</text> <paragraph num="(a)"> <text>“Standards of licensed practical nurse practice” means the minimum criteria to which the licensed nurse shall adhere in the practice of licensed practical nursing.</text> </paragraph> <paragraph num="(b)"> <text>“Standards of licensed practical nurse practice” includes standards of professional performance as described in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Supervision” means the process of critically watching an individual’s performance with the intention of evaluating and directing the individual’s performance in the delivery of nursing care.</text> </paragraph> <paragraph num="(23)"> <text>“Support” means to promote, assist, or help.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Nursing Process."> <paragraph num="A."> <text>In a team relationship the licensed practical nurse contributes to the nursing process. The nursing process shall include, but is not limited to, the following elements listed in §B—C of this regulation.</text> </paragraph> <paragraph num="B."> <text>Nursing Assessment. The LPN contributes to the nursing assessment by:</text> <paragraph num="(1)"> <text>Collecting data for the assessment of the client:</text> <paragraph num="(a)"> <text>Through direct observation;</text> </paragraph> <paragraph num="(b)"> <text>From interviews with the client, client’s family, and significant others;</text> </paragraph> <paragraph num="(c)"> <text>From the review of the client’s medical records including, but not limited to:</text> <paragraph num="(i)"> <text>Past history;</text> </paragraph> <paragraph num="(ii)"> <text>Laboratory studies;</text> </paragraph> <paragraph num="(iii)"> <text>Medications; and</text> </paragraph> <paragraph num="(iv)"> <text>Consultations; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>By assessing the environment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Performing a focused nursing assessment of the client’s current conditions and problems or needs which includes:</text> <paragraph num="(a)"> <text>The nursing interview;</text> </paragraph> <paragraph num="(b)"> <text>A physical assessment;</text> </paragraph> <paragraph num="(c)"> <text>The client’s common predictable, chronic, routine, recurrent health problems; and</text> </paragraph> <paragraph num="(d)"> <text>Identification of any changes in the client’s symptoms and behavior;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Communicating the assessment on records that reflect:</text> <paragraph num="(a)"> <text>Changes in the client’s health status; and</text> </paragraph> <paragraph num="(b)"> <text>A continuous collection of data by updating and revising of the nursing assessment; and</text> </paragraph> <paragraph num="(c)"> <text>Data recorded in a manner which is:</text> <paragraph num="(i)"> <text>Complete, timely, and accurate;</text> </paragraph> <paragraph num="(ii)"> <text>Consistent with general standards of nursing practice; and</text> </paragraph> <paragraph num="(iii)"> <text>Consistent with the facility’s policies and procedures.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Nursing Plan of Care.</text> <paragraph num="(1)"> <text>Development. The LPN contributes to the development of the nursing plan of care by:</text> <paragraph num="(a)"> <text>Reporting ongoing data collection;</text> </paragraph> <paragraph num="(b)"> <text>Reporting changes that include, but are not limited to, the client’s;</text> <paragraph num="(i)"> <text>Condition;</text> </paragraph> <paragraph num="(ii)"> <text>Changed goals; and</text> </paragraph> <paragraph num="(iii)"> <text>Changed priorities;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Making recommendations to individualize interventions specific to the client;</text> </paragraph> <paragraph num="(d)"> <text>Reporting communication with;</text> <paragraph num="(i)"> <text>The client;</text> </paragraph> <paragraph num="(ii)"> <text>The client’s family;</text> </paragraph> <paragraph num="(iii)"> <text>Significant others; and</text> </paragraph> <paragraph num="(iv)"> <text>Other members of the health care team; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Documenting in appropriate records.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Implementation. The LPN participates in the implementation of the nursing plan of care by:</text> <paragraph num="(a)"> <text>Continuing to collect and report data;</text> </paragraph> <paragraph num="(b)"> <text>Assisting in the coordination of client care with other health care team members as directed by the RN;</text> </paragraph> <paragraph num="(c)"> <text>Implementing standardized or RN developed teaching plans under the direction of the RN;</text> </paragraph> <paragraph num="(d)"> <text>Contributing to the nursing case management by:</text> <paragraph num="(i)"> <text>Implementing assigned components of the nursing care plan; and</text> </paragraph> <paragraph num="(ii)"> <text>Continuing to collect and report data regarding the implemented plan including the client’s response to intervention and problem identification;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Contributing to nursing management and supervision of the certified nursing assistant and unlicensed personnel by:</text> <paragraph num="(i)"> <text>Assuring nursing functions are performed competently and timely; and</text> </paragraph> <paragraph num="(ii)"> <text>Reporting to the leader of the nursing team; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>In accordance with the nursing team’s plan of care for the client and with COMAR10.27.11, delegating acts of the LPN’s practice to:</text> <paragraph num="(i)"> <text>The certified nursing assistant;</text> </paragraph> <paragraph num="(ii)"> <text>The certified medication technician; and</text> </paragraph> <paragraph num="(iii)"> <text>Unlicensed personnel;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Performing nursing interventions in a competent safe manner appropriate to the LPN’s scope of practice including:</text> <paragraph num="(i)"> <text>Administration of medications and treatments;</text> </paragraph> <paragraph num="(ii)"> <text>Administration of infusion therapy consistent with COMAR 10.27.20; and</text> </paragraph> <paragraph num="(iii)"> <text>Nursing intervention consistent with any declaratory rulings and regulations issued by the Board;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Documenting implementation of nursing care timely, completely, and accurately; and</text> <paragraph num="(i)"> <text>Utilizing identified nursing approaches which include, but are not limited to:</text> </paragraph> <paragraph num="(ii)"> <text>Reflecting knowledge of scientific principles;</text> </paragraph> <paragraph num="(iii)"> <text>Recognizing the rights of the client, the client’s family, and significant others; and</text> </paragraph> <paragraph num="(iv)"> <text>Providing a safe and therapeutic environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Evaluation. The LPN contributes to the evaluation of the nursing plan of care by:</text> <paragraph num="(a)"> <text>Collecting and communicating data on the client’s goal achievement;</text> </paragraph> <paragraph num="(b)"> <text>Assisting in identifying barriers to the client’s meeting any identified goal;</text> </paragraph> <paragraph num="(c)"> <text>Reporting to other members of the health care team in a timely, accurate, and complete manner on data collected from;</text> <paragraph num="(i)"> <text>The client;</text> </paragraph> <paragraph num="(ii)"> <text>The client’s family;</text> </paragraph> <paragraph num="(iii)"> <text>Significant others; and</text> </paragraph> <paragraph num="(iv)"> <text>Other health care providers;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Assisting in evaluating the client’s competency in performing any treatment and self administering medication by utilizing established competency based evaluation tools;</text> </paragraph> <paragraph num="(e)"> <text>Making recommendations regarding modification of the teaching nursing plan based on the client’s response;</text> </paragraph> <paragraph num="(f)"> <text>Making recommendations regarding any revision to the nursing plan of care; and</text> </paragraph> <paragraph num="(g)"> <text>Documenting the evaluation data on appropriate records.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Nursing Team Relationship.</text> <paragraph num="(a)"> <text>The LPN as a part of the nursing team:</text> <paragraph num="(i)"> <text>Functions as a team member under the leadership of the RN who is the team leader;</text> </paragraph> <paragraph num="(ii)"> <text>Participates in providing care for the client; and</text> </paragraph> <paragraph num="(iii)"> <text>Provides care for the client to the fullest extent allowed by the LPN’s scope of practice.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Each licensed nurse has responsibility for oversight or supervision of nursing practice appropriate to his or her level of licensure which includes critically watching, instructing, directing, and evaluating anothers nursing practice.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation. The LPN shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Professional Performance."> <paragraph num="A."> <text>Quality of Care.</text> <paragraph num="(1)"> <text>The LPN shall participate in evaluating the quality and effectiveness of nursing practice.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Assist in collecting quality data; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in activities related to implementing changes designed to improve care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Performance Appraisal.</text> <paragraph num="(1)"> <text>The LPN shall be accountable for evaluating the LPN’s own nursing practice on a regular basis in relation to:</text> <paragraph num="(a)"> <text>Relevant professional practice standards; and</text> </paragraph> <paragraph num="(b)"> <text>Relevant statutes and regulations governing licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The LPN shall:</text> <paragraph num="(i)"> <text>Participate in peer review as appropriate; and</text> </paragraph> <paragraph num="(ii)"> <text>As necessary, seek guidance, support, education, and supervision.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The LPN shall demonstrate knowledge of and comply with:</text> <paragraph num="(i)"> <text>Relevant professional practice standards;</text> </paragraph> <paragraph num="(ii)"> <text>Relevant statutes and regulations governing licensed practical nursing; and</text> </paragraph> <paragraph num="(iii)"> <text>The policies and procedures of the practice setting.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Education.</text> <paragraph num="(1)"> <text>The LPN shall acquire and maintain current knowledge and continued competency in the practice of licensed practical nursing.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Participate in educational opportunities and experiences to maintain professional competence; and</text> </paragraph> <paragraph num="(b)"> <text>Obtain knowledge and skills appropriate to the practice setting.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Collegiality.</text> <paragraph num="(1)"> <text>The LPN shall support the professional development of the:</text> <paragraph num="(a)"> <text>Licensed practical nurse;</text> </paragraph> <paragraph num="(b)"> <text>Certified nursing assistant;</text> </paragraph> <paragraph num="(c)"> <text>Certified medication technician; and</text> </paragraph> <paragraph num="(d)"> <text>Unlicensed personnel.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>As directed by the RN, the LPN shall share knowledge and skills with:</text> <paragraph num="(i)"> <text>Other LPNs;</text> </paragraph> <paragraph num="(ii)"> <text>Certified nursing assistants;</text> </paragraph> <paragraph num="(iii)"> <text>Certified medication technicians; and</text> </paragraph> <paragraph num="(iv)"> <text>Unlicensed personnel.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The LPN shall contribute to a supportive and healthy work environment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Ethics.</text> <paragraph num="(1)"> <text>The licensed practical nurse’s decisions and actions shall reflect ethical principles.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Comply with the Code of Ethics as described in COMAR 10.27.19;</text> </paragraph> <paragraph num="(b)"> <text>Maintain client confidentiality within legal and regulatory standards;</text> </paragraph> <paragraph num="(c)"> <text>Act as a client advocate;</text> </paragraph> <paragraph num="(d)"> <text>Deliver care in a nonjudgmental and nondiscriminatory manner that is sensitive to client diversity;</text> </paragraph> <paragraph num="(e)"> <text>Deliver care in a manner that preserves the client’s;</text> <paragraph num="(i)"> <text>Autonomy;</text> </paragraph> <paragraph num="(ii)"> <text>Dignity; and</text> </paragraph> <paragraph num="(iii)"> <text>Rights;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Communicate with the RN regarding potential ethical issues; and</text> </paragraph> <paragraph num="(g)"> <text>Communicate to the RN, observations of actions by other health care providers which may jeopardize the client’s safety and well being.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Collaboration.</text> <paragraph num="(1)"> <text>The LPN shall participate with the client, the client’s family, significant others, the RN, and other health care providers in providing care.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Participate with the client, the client’s family, significant others, the RN, and other health care providers by contributing to:</text> <paragraph num="(i)"> <text>The development of overall goals;</text> </paragraph> <paragraph num="(ii)"> <text>The nursing plan of care; and</text> </paragraph> <paragraph num="(iii)"> <text>Decisions related to care and the delivery of services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Consult with the RN and other health care providers regarding client care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Research.</text> <paragraph num="(1)"> <text>The LPN shall support research activities appropriate to the LPN’s scope of practice.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Have knowledge of the client’s rights related to research;</text> </paragraph> <paragraph num="(b)"> <text>Participate in data collection; and,</text> </paragraph> <paragraph num="(c)"> <text>Utilize established facility-approved research protocols.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Resource Utilization.</text> <paragraph num="(1)"> <text>The LPN shall consider factors related to safety and cost when participating in client care planning and implementing client care.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria. The LPN shall:</text> <paragraph num="(a)"> <text>Assist the client, the client’s family, and significant others to identify:</text> <paragraph num="(i)"> <text>Unmet client needs; and</text> </paragraph> <paragraph num="(ii)"> <text>Potential services to meet any unmet needs; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evaluate factors related to client safety and cost when performing or delegating client care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Delegation and Supervision.</text> <paragraph num="(1)"> <text>When the delegation does not jeopardize the client’s welfare, the LPN may delegate nursing tasks to a certified nursing assistant, medication technician, or an unlicensed person who is competent to perform those acts or tasks.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>When delegating a nursing task, the LPN shall assess the client and determine that the delegation is consistent with COMAR 10.27.11.</text> </paragraph> <paragraph num="(b)"> <text>When delegating nursing tasks, the LPN shall assess the capabilities, experience, and competency of a person working under the LPN’s supervision.</text> </paragraph> <paragraph num="(c)"> <text>When delegating a nursing task to a certified nursing assistant, medication technician, or an unlicensed person, the LPN shall:</text> <paragraph num="(i)"> <text>Instruct;</text> </paragraph> <paragraph num="(ii)"> <text>Direct;</text> </paragraph> <paragraph num="(iii)"> <text>Regularly evaluate the performance of nursing tasks by the certified nursing assistant, medication technician, or unlicensed person;</text> </paragraph> <paragraph num="(iv)"> <text>Rectify a situation in which the certified nursing assistant, medication technician, or unlicensed person under the LPN’s supervision is performing nursing tasks that are inconsistent with generally accepted professional standards and notify the registered nurse leader of the nursing team; and</text> </paragraph> <paragraph num="(v)"> <text>Prohibit the continued performance of the certified nursing assistant, medication technician, or unlicensed person who is performing the delegated nursing task or tasks incompetently and notify the registered nurse leader of the nursing team.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Refusal.</text> <paragraph num="(1)"> <text>The LPN has the right and the responsibility to refuse to perform, or delegate nursing acts.</text> </paragraph> <paragraph num="(2)"> <text>Measurement Criteria.</text> <paragraph num="(a)"> <text>The LPN has the right and responsibility to refuse to perform a nursing act which is beyond the parameters of the LPN’s:</text> <paragraph num="(i)"> <text>Education;</text> </paragraph> <paragraph num="(ii)"> <text>Capabilities;</text> </paragraph> <paragraph num="(iii)"> <text>Clinical competency; and</text> </paragraph> <paragraph num="(iv)"> <text>Scope of practice.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The LPN shall obtain appropriate education, training, and supervision as required to perform nursing functions which are within the LPN’s scope of practice but are beyond the parameters of the licensee’s clinical competency.</text> </paragraph> <paragraph num="(c)"> <text>The LPN has the right to refuse to accept responsibility and accountability for supervising, monitoring, instructing, or evaluating a certified nursing assistant, certified medication technician, or an unlicensed person performing a nursing task that has not been delegated by that licensee.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prohibited Acts."> <text>The LPN may not:</text> <paragraph num="A."> <text>Perform nursing triage;</text> </paragraph> <paragraph num="B."> <text>Perform the responsibilities of, or serve in the role of, the circulating nurse in the intraoperative phase of surgery including, but not limited to:</text> <paragraph num="(1)"> <text>Assessing the client in the intraoperative phase of surgery to identify emerging client situations which would require anticipating and responding to the needs of the:</text> <paragraph num="(a)"> <text>Client;</text> </paragraph> <paragraph num="(b)"> <text>Anesthesiologist; and</text> </paragraph> <paragraph num="(c)"> <text>Surgical team;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Administering or transporting to the surgical field medications, infusates, or solutions that may be required by the anesthesia or surgical team during the course of the intraoperative procedure;</text> </paragraph> <paragraph num="(3)"> <text>Gathering needed equipment and anticipating resuscitation efforts during the intraoperative phase;</text> </paragraph> <paragraph num="(4)"> <text>Collaborating with other members of the surgical team for ongoing assessment and planning for the client’s postoperative care; and</text> </paragraph> <paragraph num="(5)"> <text>Documenting completely, timely, and accurately on appropriate records;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Perform the comprehensive nursing assessment;</text> </paragraph> <paragraph num="D."> <text>Serve as the case manager for client care;</text> </paragraph> <paragraph num="E."> <text>Supervise the nursing practice of RNs and other LPNs; and</text> </paragraph> <paragraph num="F."> <text>Analyze client data in order to determine client outcome identification and formulation of a nursing diagnosis.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §§8-205(a)(2) and 8-316, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 20, 1989 (16:3 Md. R. 343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 25, 1993 (20:21 Md. R. 1655)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.04 adopted effective May 2, 2011 (38:9 Md. R. 553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="11" heading="Delegation of Nursing Functions"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <text>This chapter is not applicable to and does not restrict or limit:</text> <paragraph num="A."> <text>Other health care practitioners who are authorized delegatory powers under their respective acts;</text> </paragraph> <paragraph num="B."> <text>The gratuitous provision of care by self, family, or friends;</text> </paragraph> <paragraph num="C."> <text>Provision of care by a child care provider employed in the child's home by the child's parent or by a child care provider licensed by the Child Care Administration under COMAR 07.04.01 (Family Day Care) or COMAR 07.04.02 (Child Care Center Licensing) except for those providers enrolling a majority of children with health or medical conditions or both;</text> </paragraph> <paragraph num="D."> <text>The cognitively capable adult from employing an unlicensed caregiver in the adult's home to assist the adult in treatments of a routine nature and in self-administration of medication;</text> </paragraph> <paragraph num="E."> <text>An individual who performs nursing assistant tasks while a nursing student enrolled in an accredited nursing education program and practicing under the direct supervision of:</text> <paragraph num="(1)"> <text>Qualified faculty or preceptors; or</text> </paragraph> <paragraph num="(2)"> <text>A nurse while working as a nursing assistant;</text> </paragraph> </paragraph> <paragraph num="F."> <text>An individual who performs nursing assistant tasks as a student while:</text> <paragraph num="(1)"> <text>Enrolled in a Board-approved nursing assistant training program;</text> </paragraph> <paragraph num="(2)"> <text>Practicing under the direct supervision of qualified faculty or preceptors; or</text> </paragraph> <paragraph num="(3)"> <text>Practicing under the direct supervision of a nurse while working as a nursing assistant;</text> </paragraph> </paragraph> <paragraph num="G."> <text>A nurse from delegating a nursing task to an unlicensed individual if acceptance of delegated nursing tasks does not become a routine part of the unlicensed individual's job duties; or</text> </paragraph> <paragraph num="H."> <text>A youth camp regulated in accordance with COMAR 10.16.06.</text> </paragraph> <paragraph num="I."> <text>A certified dialysis technician regulated in accordance with COMAR 10.39.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accountability” means being answerable for actions of self or others.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Certified medicine aide (CMA)” means an individual who meets the requirements as stated in COMAR 10.39.01 and 10.39.03.</text> </paragraph> <paragraph num="(4)"> <text>“Certified nursing assistant (CNA)” means an individual certified by the Board as a nursing assistant.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means the recipient of nursing care.</text> </paragraph> <paragraph num="(6)"> <text>“Delegation” means the act of authorizing an unlicensed individual, a certified nursing assistant, or a medication technician to perform acts of registered nursing or licensed practical nursing.</text> </paragraph> <paragraph num="(7)"> <text>“Evaluation” means the review and analysis of the extent to which the assessment, nursing diagnosis, planning, and implementation phases of the nursing process were effective in resolving the client's identified problems.</text> </paragraph> <paragraph num="(8)"> <text>“Family” means related family members, foster parents, domestic partners, and legal guardians.</text> </paragraph> <paragraph num="(9)"> <text>“Geriatric nursing assistant (GNA)” means a CNA who has successfully completed the requirements for a GNA set forth in 42 CFR §§483.151 — 483.156 and COMAR 10.39.01.</text> </paragraph> <paragraph num="(10)"> <text>“Home health aide (HHA)” means a CNA who has successfully completed the requirements for certification as a HHA set forth in 42 CFR §484.36 and COMAR 10.39.01.</text> </paragraph> <paragraph num="(11)"> <text>“Licensed practical nurse” means an individual who is licensed by the Board to practice licensed practical nursing or has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> <paragraph num="(12)"> <text>“Medication technician” means an individual who completes a 20-hour course in medication administration approved by the Board and is certified by the Board.</text> </paragraph> <paragraph num="(13)"> <text>Model of Nursing Practice.</text> <paragraph num="(a)"> <text>“Model of nursing practice” means the policies, procedures, and practice guidelines:</text> <paragraph num="(i)"> <text>Established by the facility, which are consistent with this chapter regarding delegation of nursing functions and regulations governing the facility; and</text> </paragraph> <paragraph num="(ii)"> <text>That provide direction to nursing staff on the delivery of care to the client population which the facility serves.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>"Model of nursing practice” may not supersede a delegating nurse's prudent judgment regarding:</text> <paragraph num="(i)"> <text>Delegation of a nursing function to a certified nursing assistant, an unlicensed individual, or a medication technician; or</text> </paragraph> <paragraph num="(ii)"> <text>A particular delegated nursing function to that individual or individuals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(15)"> <text>“Nurse” means a registered nurse or licensed practical nurse.</text> </paragraph> <paragraph num="(16)"> <text>“Pressure ulcer” means a decubitus ulcer stage I through IV, the care for which includes cleaning, applying topical medication, and dressing without packing.</text> </paragraph> <paragraph num="(17)"> <text>“Readily available” means, in:</text> <paragraph num="(a)"> <text>A structured setting:</text> <paragraph num="(i)"> <text>The delegating nurse is physically present on the unit; and</text> </paragraph> <paragraph num="(ii)"> <text>The nurse may transfer responsibility for the nursing supervision and delegation to another nurse who then becomes the nurse delegating the nursing functions; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Other settings, the delegating nurse is on the premises or else is available by telephone.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Responsibility” means the charge to do something.</text> </paragraph> <paragraph num="(20)"> <text>“Routine care” means those activities necessary on a daily basis for the client to gain or maintain a level of functioning.</text> </paragraph> <paragraph num="(21)"> <text>“Structured setting” means a hospital, nursing home, long-term care facility, ambulatory care setting, surgicenter, or any other acute or chronic care facility.</text> </paragraph> <paragraph num="(22)"> <text>“Supervised group living settings” means assisted living facilities, group homes for juveniles, group homes for emotionally disturbed children, alternative living units for the developmentally disabled, or any other facility or setting providing supervised living arrangements for groups of unrelated individuals.</text> </paragraph> <paragraph num="(23)"> <text>“Supervision” means the process of critical watching, directing, and evaluating another's performance.</text> </paragraph> <paragraph num="(24)"> <text>“Unlicensed individual” means an individual who is not licensed or certified to provide nursing care under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(25)"> <text>Wound.</text> <paragraph num="(a)"> <text>“Wound” means venous stasis ulcer or ulcers, a dehissed wound, or any other break in the integrity of the full thickness of skin that involves the subcutaneous tissue or fascia.</text> </paragraph> <paragraph num="(b)"> <text>“Wound” may include tunneling or a sinus tract.</text> </paragraph> <paragraph num="(c)"> <text>“Wound” does not include an uncomplicated healing surgical wound.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Criteria for Delegation."> <paragraph num="A."> <text>The nurse may delegate the responsibility to perform a nursing task to an unlicensed individual, a certified nursing assistant, or a medication technician. The delegating nurse retains the accountability for the nursing task.</text> </paragraph> <paragraph num="B."> <text>A nursing task delegated by the nurse shall be:</text> <paragraph num="(1)"> <text>Within the area of responsibility of the nurse delegating the act;</text> </paragraph> <paragraph num="(2)"> <text>Such that, in the judgment of the nurse, it can be properly and safely performed by the unlicensed individual, certified nursing assistant, or medication technician without jeopardizing the client welfare; and</text> </paragraph> <paragraph num="(3)"> <text>A task that a reasonable and prudent nurse would find is within the scope of sound nursing judgment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A nursing task delegated by the nurse may not require the unlicensed individual, certified nursing assistant, or medication technician to exercise nursing judgment or intervention except in an emergency situation.</text> </paragraph> <paragraph num="D."> <text>When delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician the nurse shall:</text> <paragraph num="(1)"> <text>Make an assessment of the patient's nursing care needs before delegating the task;</text> </paragraph> <paragraph num="(2)"> <text>Either instruct the unlicensed individual, certified nursing assistant, or medication technician in the delegated task or verify the unlicensed individual's, certified nursing assistant's, or medication technician's competency to perform the nursing task;</text> </paragraph> <paragraph num="(3)"> <text>Supervise the performance of the delegated nursing task in accordance with Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Be accountable and responsible for the delegated task;</text> </paragraph> <paragraph num="(5)"> <text>Evaluate the performance of the delegated nursing task; and</text> </paragraph> <paragraph num="(6)"> <text>Be responsible for assuring accurate documentation of outcomes on the nursing record.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The nurse shall be the primary decision maker when delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician. Nursing judgment shall be exercised within the context of the employing facility's model of nursing practice which includes a mechanism for:</text> <paragraph num="(1)"> <text>Identifying those individuals to whom nursing tasks may be delegated;</text> </paragraph> <paragraph num="(2)"> <text>Reevaluation of the competency of those to whom nursing tasks may be delegated;</text> </paragraph> <paragraph num="(3)"> <text>Recognizing that the final decision regarding delegation is within the scope of the nurse's professional judgment;</text> </paragraph> <paragraph num="(4)"> <text>Determining the competency of the nurse to delegate; and</text> </paragraph> <paragraph num="(5)"> <text>Determining to whom nursing tasks may be delegated, which includes input by nurses employed in the facility.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The registered nurse shall assume the role of case manager in delegating nursing tasks, including the administration of medications, only in accordance with Regulation .05G of this chapter in situations where the nurse has thoroughly assessed and documented that:</text> <paragraph num="(1)"> <text>The client's health care needs are chronic, stable, uncomplicated, routine, and predictable;</text> </paragraph> <paragraph num="(2)"> <text>The environment is conducive to the delegation of nursing tasks; and</text> </paragraph> <paragraph num="(3)"> <text>The client is unable to perform his or her own care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Supervision."> <paragraph num="A."> <text>The nurse shall determine the required degree of supervision after an evaluation of appropriate factors including, but not limited to the:</text> <paragraph num="(1)"> <text>Stability of the condition of the client;</text> </paragraph> <paragraph num="(2)"> <text>Training of the individual to whom the nursing task is being delegated;</text> </paragraph> <paragraph num="(3)"> <text>Nature of the nursing task being delegated;</text> </paragraph> <paragraph num="(4)"> <text>Orientation of the unlicensed individual, certified nursing assistant, or medication technician to the specific patient environment;</text> </paragraph> <paragraph num="(5)"> <text>Ability of the unlicensed individual, certified nursing assistant, or medication technician to perform the delegated nursing task in a safe and competent manner; and</text> </paragraph> <paragraph num="(6)"> <text>Reevaluation of the client's health status.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The delegating nurse shall be readily available when delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician.</text> </paragraph> <paragraph num="C."> <text>For the client whose health status meets the criteria as stated in Regulation .03F of this chapter, the registered nurse managing the case shall make a supervisory on-site visit to the client at a minimum of every 45 days to:</text> <paragraph num="(1)"> <text>Evaluate the client's health status;</text> </paragraph> <paragraph num="(2)"> <text>Evaluate the nursing acts to be delegated;</text> </paragraph> <paragraph num="(3)"> <text>Determine whether health goals are being met;</text> </paragraph> <paragraph num="(4)"> <text>Evaluate the continued competence of the certified nursing assistant, unlicensed individual, or medication technician to perform the delegated nursing task; and</text> </paragraph> <paragraph num="(5)"> <text>Evaluate the environment in which the delegated task is performed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For the client whom the registered nurse has determined does not meet the criteria as stated in Regulation .03F of this chapter, the registered nurse shall:</text> <paragraph num="(1)"> <text>Make a supervisory on-site visit to the client at least every 2 weeks to evaluate the criteria described in §C of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Determine whether the:</text> <paragraph num="(a)"> <text>Nursing tasks may be safely delegated in that setting and given the client's clinical status; and</text> </paragraph> <paragraph num="(b)"> <text>Nursing assistant, unlicensed individual, or medication technician is competent to perform the nursing tasks to be delegated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Nursing Functions."> <paragraph num="A."> <text>The following nursing functions require nursing knowledge, judgment, and skill and may not be delegated:</text> <paragraph num="(1)"> <text>The nursing assessment including, but not limited to, the admission, shift, transfer, or discharge assessment;</text> </paragraph> <paragraph num="(2)"> <text>Development of the nursing diagnosis;</text> </paragraph> <paragraph num="(3)"> <text>The establishment of the nursing care goal;</text> </paragraph> <paragraph num="(4)"> <text>Development of the nursing care plan;</text> </paragraph> <paragraph num="(5)"> <text>Evaluation of the client's progress, or lack of progress, toward goal achievement; and</text> </paragraph> <paragraph num="(6)"> <text>Any nursing task which requires nursing knowledge, judgment, and skill.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nurse may delegate treatments of a routine nature if:</text> <paragraph num="(1)"> <text>The licensed nursing staff of the specific unit of care has identified the function as being routinely performed;</text> </paragraph> <paragraph num="(2)"> <text>The specific treatments are performed at a high frequency necessary to retain competency;</text> </paragraph> <paragraph num="(3)"> <text>The treatment has an inherently low risk to the client; as determined by weighing the following factors:</text> <paragraph num="(a)"> <text>Type of equipment utilized to perform the function;</text> </paragraph> <paragraph num="(b)"> <text>Nurse staffing ratio that allows for close supervision;</text> </paragraph> <paragraph num="(c)"> <text>Basic educational preparation of the unlicensed individual or certified nursing assistant performing the delegated function; and</text> </paragraph> <paragraph num="(d)"> <text>Knowledge and skill set of the nurse delegating and supervising the delegated function; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>There is a quality assurance mechanism in place to assure the function is performed safely and client outcomes meet accepted professional nursing standards including, but not limited to:</text> <paragraph num="(a)"> <text>An ongoing formalized documented performance appraisal mechanism designed to assure that unlicensed individual or certified nursing assistant's revalidation of continued competency is a component of the quality assurance mechanism; and</text> </paragraph> <paragraph num="(b)"> <text>Client outcomes meeting accepted professional standards, as reflected by:</text> <paragraph num="(i)"> <text>Infection rates;</text> </paragraph> <paragraph num="(ii)"> <text>Rates of adverse events;</text> </paragraph> <paragraph num="(iii)"> <text>Error rates; and</text> </paragraph> <paragraph num="(iv)"> <text>Patient satisfaction surveys.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The nurse may delegate the obtaining of specific information to an unlicensed individual or certified nursing assistant.</text> </paragraph> <paragraph num="D."> <text>When implementing the plan of care, the nurse may delegate a nursing task to an unlicensed individual or certified nursing assistant after the nurse has completed a client assessment and when the delegation of that task does not jeopardize the client's welfare.</text> </paragraph> <paragraph num="E."> <text>The nurse may delegate the responsibility to perform a nursing task to an unlicensed individual if:</text> <paragraph num="(1)"> <text>Acceptance of the delegated nursing task does not become a routine part of the unlicensed individual's job duties; or</text> </paragraph> <paragraph num="(2)"> <text>An unlicensed individual merely provides assistance with activities of daily living unless the client's needs are such that adverse health consequences are predictable.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Administration of medication is a nursing function. As such, the nurse retains full responsibility for medication administration.</text> </paragraph> <paragraph num="G."> <text>The following activities related to medication administration may not be delegated except as provided in §H of this regulation:</text> <paragraph num="(1)"> <text>Calculation of any medication dose;</text> </paragraph> <paragraph num="(2)"> <text>Administration of medications by injection route;</text> </paragraph> <paragraph num="(3)"> <text>Administration of medications by way of a tube inserted in a cavity of the body; and</text> </paragraph> <paragraph num="(4)"> <text>Administration of medication by intravenous route.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Delegation of Medication Administration.</text> <paragraph num="(1)"> <text>The administration of medication as listed in §H(3) of this regulation may be delegated to certified medicine aides and medication technicians only in compliance with §H(2) of this regulation and when clients meet the requirements of Regulation .03F or .04D of this chapter in the following situations:</text> <paragraph num="(a)"> <text>Supervised group living settings;</text> </paragraph> <paragraph num="(b)"> <text>Supervised or sheltered work settings;</text> </paragraph> <paragraph num="(c)"> <text>Independent living settings;</text> </paragraph> <paragraph num="(d)"> <text>Schools;</text> </paragraph> <paragraph num="(e)"> <text>Correctional institutions;</text> </paragraph> <paragraph num="(f)"> <text>Hospice care;</text> </paragraph> <paragraph num="(g)"> <text>Adult medical day care centers; and</text> </paragraph> <paragraph num="(h)"> <text>Child care centers established for children with health or medical conditions or both.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A nurse may delegate to a medication technician or certified medicine aide under this section when:</text> <paragraph num="(a)"> <text>The nurse has provided instruction and direction; and</text> </paragraph> <paragraph num="(b)"> <text>The medication technician or certified medicine aide is on site in the unit of care on a continuing basis to:</text> <paragraph num="(i)"> <text>Monitor the therapeutic effects of the medication;</text> </paragraph> <paragraph num="(ii)"> <text>Observe, record, and report untoward effects of the medication;</text> </paragraph> <paragraph num="(iii)"> <text>Perform monitoring procedures required for each medication;</text> </paragraph> <paragraph num="(iv)"> <text>Observe for changes in the individual client's behavior and clinical status;</text> </paragraph> <paragraph num="(v)"> <text>Record and report the changes observed to the delegating nurse; and</text> </paragraph> <paragraph num="(vi)"> <text>Withhold administration of the medication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A nurse may delegate administration of the following medications to a medication technician or a certified medicine aide according to Regulations .03F, .04C, and .05H(1) of this chapter:</text> <paragraph num="(a)"> <text>Medication by metered dose inhalant, nebulizer, and oxygen by nasal cannula or mask;</text> </paragraph> <paragraph num="(b)"> <text>Medication by gastrostomy tube or rectal tube if the nurse has calculated the dosage;</text> </paragraph> <paragraph num="(c)"> <text>Oral medication, including:</text> <paragraph num="(i)"> <text>Measuring as prescribed an amount of liquid medication where the nurse has calculated the dose; and</text> </paragraph> <paragraph num="(ii)"> <text>Administering a fraction of a tablet if the nurse has cut the tablet;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Medication by subcutaneous injection if the nurse has calculated the dose;</text> </paragraph> <paragraph num="(e)"> <text>Medication administered by topical route excluding stage III and IV pressure ulcers and wound care;</text> </paragraph> <paragraph num="(f)"> <text>Medication administered by suppository route;</text> </paragraph> <paragraph num="(g)"> <text>Medication drops administered by routes involving eye, ear, and nose; and</text> </paragraph> <paragraph num="(h)"> <text>Where the registered nurse makes an on-site visit at least every 7 days to assess the client status and the performance of the medication technician's or certified medicine aide's administration of topical medication to stage three or four pressure ulcers or wounds.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Client Health Teaching and Health Counseling."> <paragraph num="A."> <text>The registered nurse shall be accountable and responsible for the development and initiation of the health teaching plan and for health counseling of the client.</text> </paragraph> <paragraph num="B."> <text>The nurse shall be accountable and responsible for facilitating and promoting:</text> <paragraph num="(1)"> <text>Client education; and</text> </paragraph> <paragraph num="(2)"> <text>Participation of the client and significant others in implementation of health goals.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unlicensed individuals, certified medicine aides, medication technicians, and certified nursing assistants given instruction and direction by the nurse may supplement the health teaching by providing standardized information to the client.</text> </paragraph> <paragraph num="D."> <text>The unlicensed individual, certified medicine aide, medication technician, and certified nursing assistant are responsible and accountable for reporting information to the nurse regarding the client's:</text> <paragraph num="(1)"> <text>Request for information; and</text> </paragraph> <paragraph num="(2)"> <text>Response to teaching provided by the nurse.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">: Health Occupations Article, §§8-102, 8-205, 8-6A-01, 8-6A-02, 8-6A-03, 8-6A-05(a)(4), and 8-6A-08(f)(5), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 2, 1989 (16:19 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended as an emergency provision effective February 5, 1992 (19:4 Md. R. 468); emergency status expired August 7, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended permanently effective August 8, 1992 (19:11 Md. R. 1015)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.06 amended effective July 4, 1994 (21:13 Md. R. 1158)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed and new Regulations .01—.06 adopted effective May 10, 2004 (31:9 Md. R. 712)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01H adopted as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); adopted permanently effective July 20, 2015 (42:14 Md. R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01I adopted effective August 4, 2025 (52:15 Md. R. 812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 28, 2005 (32:4 Md. R. 411); January 26, 2009 (36:2 Md. R. 101); September 19, 2011 (38:19 Md. R. 1147); July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 29, 2009 (36:13 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C, D amended effective September 19, 2011 (38:19 Md. R. 1147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 28, 2005 (32:4 Md. R. 411); January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05H amended effective September 19, 2011 (38:19 Md. R. 1147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, D amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> </annotations> </chapter> <chapter num="12" heading="Nurse Psychotherapists in Independent Practice — Clinical Nurse Specialists"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <text>Nothing in this chapter shall be applicable to or restrict or limit a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as:</text> <paragraph num="(a)"> <text>A certified nurse midwife (CNM);</text> </paragraph> <paragraph num="(b)"> <text>A certified registered nurse anesthetist (CRNA);</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse practitioner (CRNP); or</text> </paragraph> <paragraph num="(d)"> <text>A clinical nurse specialist (CNS).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Certification” means the permission to practice as a PMH/APRN granted by the Board to a registered nurse who has:</text> <paragraph num="(a)"> <text>Met all the specified requirements of a national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Complied with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Mental health diagnosis” means the identification of a potential or an actual alteration in an individual's mental health status.</text> </paragraph> <paragraph num="(5)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(6)"> <text>“Nurse psychotherapist” means a registered nurse, certified under this chapter, who utilizes psychotherapy in a formally structured, contractual relationship between the nurse therapist and a client.</text> </paragraph> <paragraph num="(7)"> <text>“Psychiatric mental health/ advanced practice registered nurse (PMH/APRN)” means an advanced practice registered nurse who:</text> <paragraph num="(a)"> <text>Is certified by the Board as a clinical nurse specialist in the practice of psychiatric mental health; and</text> </paragraph> <paragraph num="(b)"> <text>Autonomously and independently engages in activities authorized by this chapter.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Psychobiological interventions” means interventions which integrate physiological and psychological dimensions of care and include a range of therapies from diet/nutrition regulation, hypnosis, and relaxation techniques to the use of pharmacologic agents.</text> </paragraph> <paragraph num="(9)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Certification."> <text>An applicant for certification to practice as a PMH/APRN in independent practice shall:</text> <paragraph num="A."> <text>Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="B."> <text>Have graduated from a Board-approved graduate level education program for clinical nurse specialists in psychiatric mental health nursing at the Masters’ level or higher that is accredited by a national accrediting body recognized by the Board;</text> </paragraph> <paragraph num="C."> <text>Hold current national certification as a clinical nurse specialist in psychiatric or mental health nursing issued by the American Nurses Credentialing Center (ANCC) or any other national certifying body recognized by the Board;</text> </paragraph> <paragraph num="D."> <text>Submit to the Board a completed application for certification as a clinical nurse specialist, PMH/APRN;</text> </paragraph> <paragraph num="E."> <text>Comply with all the requirements set forth in COMAR 10.27.01.04;</text> </paragraph> <paragraph num="F."> <text>Demonstrate written and oral competency in the English language; and</text> </paragraph> <paragraph num="G."> <text>Pay all fees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Practice Before Maryland Certification."> <paragraph num="A."> <text>A registered nurse who meets the qualifications to sit for a national certifying examination acceptable to the Board or who has taken that examination and is waiting for the results, may practice in this State as a PMH/APRN graduate if the:</text> <paragraph num="(1)"> <text>Practice is under the supervision of a Maryland certified PMH/APRN who shall be readily available to the PMH/APRN graduate;</text> </paragraph> <paragraph num="(2)"> <text>Supervising PMH/APRN agrees in a written supervision agreement on a form to be prescribed by the Board to provide the supervision; and</text> </paragraph> <paragraph num="(3)"> <text>PMH/APRN graduate:</text> <paragraph num="(a)"> <text>Completes the application for Maryland certification as a as a clinical nurse specialist in psychiatric mental health; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the certification application fee established by the Board in COMAR 10.27.01.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A PMH/APRN graduate who has entered into a supervision agreement shall immediately notify the Board and the supervising PMH/APRN of the results of the national certifying examination.</text> </paragraph> <paragraph num="C."> <text>A PMH/APRN graduate may not continue to practice under supervision for more than 24 months from the filing of all documents required under §A of this regulation or after the denial of certification, whichever occurs first.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of Practice."> <text>The PMH/APRN may perform independently, autonomously, and in a variety of settings, the following functions:</text> <paragraph num="A."> <text>Establish a mental health diagnosis;</text> </paragraph> <paragraph num="B."> <text>Evaluate and manage psychobiological intervention;</text> </paragraph> <paragraph num="C."> <text>Provide individual therapy;</text> </paragraph> <paragraph num="D."> <text>Provide group therapy;</text> </paragraph> <paragraph num="E."> <text>Provide family therapy;</text> </paragraph> <paragraph num="F."> <text>Provide any therapy which purpose is to:</text> <paragraph num="(1)"> <text>Effect change in the client in an attempt to alleviate emotional disturbances,</text> </paragraph> <paragraph num="(2)"> <text>Reverse or change maladaptive behavior, and</text> </paragraph> <paragraph num="(3)"> <text>Facilitate personality growth and development;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provide consultation to health care providers and others to:</text> <paragraph num="(1)"> <text>Influence the plans of care for clients,</text> </paragraph> <paragraph num="(2)"> <text>Enhance the abilities of others to provide behavioral, psychiatric, and mental health care, and</text> </paragraph> <paragraph num="(3)"> <text>Effect change in systems;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Provide behavioral rehabilitation care; and</text> </paragraph> <paragraph num="I."> <text>Utilize advanced practice skills to independently provide:</text> <paragraph num="(1)"> <text>Case management including psychiatric rehabilitation and home care, and</text> </paragraph> <paragraph num="(2)"> <text>Health teaching, health promotion, health prevention, and aid to the client in developing healthy patterns of living.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standards of Practice."> <paragraph num="A."> <text>Advanced practice skills shall be utilized in the collection of relevant data to comprehensively assess the client's mental health.</text> </paragraph> <paragraph num="B."> <text>Assessment data shall be analyzed in determining diagnosis.</text> </paragraph> <paragraph num="C."> <text>A plan of care shall be developed and implemented that outlines treatment to attain expected outcomes.</text> </paragraph> <paragraph num="D."> <text>Individual, group, and family psychotherapy, child psychotherapy, behavioral care, case management, and other therapeutic treatments shall be utilized to assist clients in fostering mental health, preventing mental illness and disability, and improving or regaining previous health status and functional abilities.</text> </paragraph> <paragraph num="E."> <text>Advanced knowledge of psychobiological interventions shall be utilized and clinical skills applied to maximize the client's health and prevent further disability.</text> </paragraph> <paragraph num="F."> <text>The use of psycholobiological interventions in this chapter does not authorize the prescription of medications.</text> </paragraph> <paragraph num="G."> <text>The client's progress in attaining the expected outcome shall be evaluated.</text> </paragraph> <paragraph num="H."> <text>Strategies and interventions shall be utilized to promote and maintain health and prevent mental illness.</text> </paragraph> <paragraph num="I."> <text>Decisions and actions on behalf of clients shall be determined in an ethical manner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal of Maryland Certification."> <paragraph num="A."> <text>Certification as a PMH/APRN expires at the same time as the license to practice registered nursing.</text> </paragraph> <paragraph num="B."> <text>Before a PMH/APRN’s certification expires, the PMH/APRN may renew the certification biennially if the PMH/APRN:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>Documentation of a current national certification as a PMH/APRN from a national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>A completed renewal application on a form that the Board requires; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>PMH/APRN renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J.—N.</text> </paragraph> <paragraph num="D."> <text>The PMH/APRN shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date.</text> </paragraph> <paragraph num="E."> <text>Certification as a PMH/APRN shall be deemed to have lapsed if the Board does not have a record of a current active national certification.</text> </paragraph> <paragraph num="F."> <text>Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>The Board shall maintain an up-to-date list of all PMH/APRNs certified in this State and include on the license an indication that the licensee is a PMH/APRN.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Unlawful Practices."> <paragraph num="A."> <text>Unless authorized to practice under this chapter, an individual may not use the words “advanced practice registered nurse/psychiatric mental health”, “nurse psychotherapist”, “psychiatric mental health/advanced practice registered nurse”, or any other words, letters, or symbols with the intent to represent that the individual is a psychiatric-mental health/advanced practice registered nurse.</text> </paragraph> <paragraph num="B."> <text>An individual certified under this chapter is subject to the disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>An individual may not practice as a PMH/APRN or nurse psychotherapist in this State unless the individual is certified under this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §8-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 25, 1990 (17:12 Md. R. 1494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C adopted effective August 1, 1994 (21:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective October 17, 2011 (38:21 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, C amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="13" heading="Safe Practice Committee"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has submitted an application to the Board to be licensed as a registered nurse, licensed practical nurse, electrologist, licensed certified midwife or direct-entry midwife or to be certified as an advanced practice registered nurse, a certified nursing assistant, a certified dialysis technician, or medication technician in this State.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Committee” means the Safe Practice Committee.</text> </paragraph> <paragraph num="(4)"> <text>“Certificate holder” means a certified nursing assistant, a certified dialysis technician, or medication technician.</text> </paragraph> <paragraph num="(5)"> <text>“Certified dialysis technician” means an individual certified as a dialysis technician by the Board in accordance with COMAR 10.39.06.</text> </paragraph> <paragraph num="(6)"> <text>“Certified nursing assistant” means an individual certified as a nursing assistant by the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Licensee” means a licensed certified midwife, direct-entry midwife, electrologist, licensed practical nurse, registered nurse, or advanced practice registered nurse.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed practical nurse” means an individual who is licensed by the Board to practice licensed practical nursing or has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> <paragraph num="(9)"> <text>“Medication technician” means an individual certified as a medication technician by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(11)"> <text>“Nurse” means registered nurse, advanced practice registered nurse, or licensed practical nurse.</text> </paragraph> <paragraph num="(12)"> <text>“Participant” means a registered nurse, an advanced practice registered nurse, a licensed practical nurse, a certified nursing assistant, a certified dialysis technician, a medication technician, an electrologist, a licensed direct-entry midwife, a licensed certified midwife or an applicant enrolled in the Safe Practice Program.</text> </paragraph> <paragraph num="(13)"> <text>“Program” means the Safe Practice Program.</text> </paragraph> <paragraph num="(14)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Substance use disorder” means a disorder that occurs when an individual exhibits a pattern of behaviors ranging from the misuse of, dependence on, or addiction to drugs, alcohol, or other chemicals.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Safe Practice Committee."> <paragraph num="A."> <text>Committee Appointments.</text> <paragraph num="(1)"> <text>Annually, before the September meeting, the Board shall determine the number of rehabilitation committees required in the State.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall make appointments to the committee in October in accordance with Health Occupations Article, §8-208(c)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Appointments are for a 4-year term, except in the first year of any committee when the terms are staggered.</text> </paragraph> <paragraph num="(4)"> <text>Committee members may be reappointed for one additional 4-year term.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Committee Meetings.</text> <paragraph num="(1)"> <text>The committee shall determine where meetings are held and the frequency of meetings.</text> </paragraph> <paragraph num="(2)"> <text>Confidential minutes shall be kept of the committee meetings and maintained in a confidential file at the Board's office.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall review and approve all procedures established by the committee.</text> </paragraph> <paragraph num="D."> <text>The committee shall function in accordance with Health Occupations Article, §8-208(j) — (q), Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>Powers and Duties of the Committee.</text> <paragraph num="(1)"> <text>The committee may:</text> <paragraph num="(a)"> <text>Evaluate each individual who requests to participate in the program or is referred to the program;</text> </paragraph> <paragraph num="(b)"> <text>Receive and review information about program participants; and</text> </paragraph> <paragraph num="(c)"> <text>Consider in each case if the participant can practice safely or an applicant qualifies for licensure or certification to practice.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The committee shall:</text> <paragraph num="(a)"> <text>Prepare a written plan or agreement for each participant that establishes the requirements for supervision and monitoring; and</text> </paragraph> <paragraph num="(b)"> <text>Inform each licensee, certificate holder, or applicant who requests participation in the program about:</text> <paragraph num="(i)"> <text>The procedures to be followed;</text> </paragraph> <paragraph num="(ii)"> <text>The rights and responsibilities of a participant in the program; and</text> </paragraph> <paragraph num="(iii)"> <text>The possible consequences for a participant’s noncompliance with the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>At the request of the Board, the committee may evaluate a nurse, certified nursing assistant, certified dialysis technician, medication technician, electrologist, direct-entry midwife, or licensed certified midwife with a substance use disorder or mental illness for readiness to return to practice.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Annual Committee Report. The committee shall submit to the Board each year, and as requested, a report that provides:</text> <paragraph num="(1)"> <text>The number of cases accepted, denied, or terminated with compliance or noncompliance;</text> </paragraph> <paragraph num="(2)"> <text>The number of cases referred to the program that were not eligible;</text> </paragraph> <paragraph num="(3)"> <text>The number of individuals referred to the program who declined admission to the program; and</text> </paragraph> <paragraph num="(4)"> <text>A cost analysis of the program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Criteria for Participation in the Program."> <paragraph num="A."> <text>Admission to the program is voluntary.</text> </paragraph> <paragraph num="B."> <text>Registered nurses, licensed practical nurses, direct-entry midwives, electrologists, medication technicians, advanced practice registered nurses, certified nursing assistants, certified dialysis technicians, licensed certified midwives or applicants for licensure or certification with a substance use disorder or mental illness, may be referred to the program through self-report, formal complaint, or the Board of Nursing.</text> </paragraph> <paragraph num="C."> <text>A licensee, certificate holder, or applicant requesting to participate in the program may not have:</text> <paragraph num="(1)"> <text>Caused injury to an individual while the licensee or certificate holder was practicing as a licensee or certificate holder; or</text> </paragraph> <paragraph num="(2)"> <text>Been arrested, convicted, or both, for diversion of controlled substances for sale or distribution.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The committee and each program participant shall enter into a written agreement which lists the individual requirements for the participant’s participation in the program and the conditions which shall be met by the participant.</text> </paragraph> <paragraph num="E."> <text>If a licensee, certificate holder, or applicant fails to enter into a written agreement provided by the committee, the committee shall deny admission to the program and refer the licensee, certificate holder, or applicant to the Board for consideration of disciplinary action or denial of licensure or certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Noncompliance with a Written Plan or Agreement."> <paragraph num="A."> <text>The committee may expel a participant from the program for failure to comply with any of the conditions of the plan or agreement.</text> </paragraph> <paragraph num="B."> <text>The committee shall:</text> <paragraph num="(1)"> <text>Report to the Board the name and license number of any participant who is expelled from the program; and</text> </paragraph> <paragraph num="(2)"> <text>Transfer to the Board the records of any participant expelled from the program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A participant who is expelled from the program may be subject to discipline.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Board and Committee Records."> <paragraph num="A."> <text>All Board and committee records concerning a participant are confidential and are not subject to discovery or subpoena in any civil or criminal action or disclosure under General Provisions Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Records shall be maintained in a confidential file in the Board’s office.</text> </paragraph> <paragraph num="C."> <text>After the committee has determined that a participant no longer requires monitoring and may practice safely, all records relating to the participant’s participation in the program shall be purged and destroyed 2 years after the participant is discharged from the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Participants Leaving the State."> <paragraph num="A."> <text>A participant who moves from this State to another state where a safe practice or other rehabilitation program is in place shall be transferred to that program.</text> </paragraph> <paragraph num="B."> <text>A nurse participant who moves to a state where there is no rehabilitation program shall have the nurse’s program records transferred to the Board of Nursing in that state.</text> </paragraph> <paragraph num="C."> <text>All non-nurse participants leaving the State shall be referred to the agency responsible for regulating their license or certificate in that state and shall have the participant’s records transferred to the responsible agency in that state.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Informational Booklet."> <text>The committee shall publish an informational booklet for the public that describes the program.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-208, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 20, 1992 (19:14 Md. R. 1283)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 5, 2001 (28:4 Md. R. 418)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 4, 2025 (52:15 Md. R. 812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective August 4, 2025 (52:15 Md. R. 812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 4, 2025 (52:15 Md. R. 812)</annotation> </annotations> </chapter> <chapter num="14" heading="Nursing Staff Agencies" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1994 (20:26 Md. R. 2028)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective December 17, 2007 (34:25 Md. R. 2211)</annotation> </annotations> </chapter> <chapter num="15" heading="Open Meetings — Attendance and Recording, Photographing, and Broadcasting of Sessions"> <regulation prefix="Regulation" num=".01" heading="Exclusion."> <text>The Board of Nursing is not subject to the provisions of COMAR 10.01.14, but shall be governed by this chapter.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Public Attendance."> <paragraph num="A."> <text>At any open session of the Board of Nursing, the general public may attend and observe.</text> </paragraph> <paragraph num="B."> <text>Except in instances when the Board expressly invites public testimony, questions, comments, or other forms of public participation, or when public participation is otherwise authorized by law, a member of the public attending an open session may not participate in the session.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disruptive Conduct."> <paragraph num="A."> <text>Prohibition. A person attending an open session of the Board may not engage in any conduct, including visual demonstrations such as the waving of placards, signs, or banners, that disrupts the session or that interferes with the right of members of the public to attend and observe the session.</text> </paragraph> <paragraph num="B."> <text>Action to Restore Order.</text> <paragraph num="(1)"> <text>The presiding officer may order a person who persists in conduct prohibited by §A of this regulation or who violates any other regulation concerning the conduct of the open session to be removed from the session and may request police assistance to restore order.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer may recess the session while order is restored.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Recording, Photographing, and Broadcasting of Open Sessions."> <paragraph num="A."> <text>A member of the public, including any representative of the news media, may record discussions of the Board at an open session by means of a tape recorder or any other recording device if the device does not create an excessive noise that disturbs members of the Board or other persons attending the session.</text> </paragraph> <paragraph num="B."> <text>A member of the public, including any representative of the news media, may photograph or videotape the proceedings of the Board at an open session by means of any type of camera if the camera:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light that disturbs members of the Board or other persons attending the session; and</text> </paragraph> <paragraph num="(2)"> <text>Does not create an excessive noise that disturbs members of the Board or other persons attending the session.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A representative of the news media may broadcast or televise the proceedings of the Board at an open session if the equipment used:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light that disturbs members of the Board or other persons attending the session;</text> </paragraph> <paragraph num="(2)"> <text>Does not create an excessive noise that disturbs members of the Board or other persons attending the session;</text> </paragraph> <paragraph num="(3)"> <text>Does not interfere with a person's observation of or participation in the session; and</text> </paragraph> <paragraph num="(4)"> <text>Is used openly so that it is obvious to those in attendance that the session is being recorded.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Recordings Not Part of Record."> <text>A recording of an open session made by a member of the public, or any transcript derived from such a recording, may not be considered a part of the record of any proceeding of the Board of Nursing.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §8-205; State Government Article, §§10-502h(2), 10-505, and 10-507; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 13, 1993 (20:18 Md. R. 1431)</annotation> </annotations> </chapter> <chapter num="16" heading="Registered Nurse — Workers' Compensation Medical Case Manager"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <text>This chapter is not applicable to, and does not restrict or limit, a:</text> <paragraph num="A."> <text>Registered nurse from performing those functions which constitute the practice of registered nursing as defined by law; and</text> </paragraph> <paragraph num="B."> <text>Medical claims consultant from performing medical claims consultation as defined in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Board-approved course” means an educational offering specific to the case management of the injured worker under the Workers' Compensation Commission which meets the criteria established by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Commission” means the Workers' Compensation Commission.</text> </paragraph> <paragraph num="(4)"> <text>Medical Case Management.</text> <paragraph num="(a)"> <text>“Medical case management” means any type of contact, including electronic, written, and personal, with the injured worker, for the purpose of the planning and coordination of health services appropriate to achievement of medical rehabilitation of the injured worker.</text> </paragraph> <paragraph num="(b)"> <text>“Medical case management” includes but is not limited to:</text> <paragraph num="(i)"> <text>Case assessment;</text> </paragraph> <paragraph num="(ii)"> <text>Implementation and coordination of services with the injured worker, family, and health care providers;</text> </paragraph> <paragraph num="(iii)"> <text>Evaluation of treatment results;</text> </paragraph> <paragraph num="(iv)"> <text>Coordinating community re-entry;</text> </paragraph> <paragraph num="(v)"> <text>Return to work with the employer of injury; and</text> </paragraph> <paragraph num="(vi)"> <text>Referral for further vocational rehabilitation services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Medical claims consultant” means a registered nurse who consults on medical aspects of an injured worker's rehabilitation without any contact with the injured worker.</text> </paragraph> <paragraph num="(6)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(7)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“RN-WCCM” means a registered nurse-workers' compensation medical case manager.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Certification Requirements."> <paragraph num="A."> <text>For certification as an RN-WCCM, an applicant shall:</text> <paragraph num="(1)"> <text>Hold a current license to practice registered nursing in this State or a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(2)"> <text>Submit documentation of successful completion of a Board-approved course;</text> </paragraph> <paragraph num="(3)"> <text>Submit to the Board a completed application for certification as an RN-WCCM; and</text> </paragraph> <paragraph num="(4)"> <text>Pay all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall include on the RN's license the designation WCCM.</text> </paragraph> <paragraph num="C."> <text>Certification by Endorsement. An applicant from out-of-State shall meet the requirements as stated in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Renewal of Certification."> <paragraph num="A."> <text>Unless renewed biennially, a certification to practice as an RN-WCCM expires at the same time as the registered nurse license.</text> </paragraph> <paragraph num="B."> <text>Before certification as an RN-WCCM expires, the RN-WCCM may renew the certification for an additional term, if the RN—WCCM:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Has practiced a minimum of 2,000 hours in the past 2 years as an RN—WCCM;</text> </paragraph> <paragraph num="(3)"> <text>Submits a completed application for renewal on the form the Board requires; and</text> </paragraph> <paragraph num="(4)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the registered nurse does not meet the practice requirement stated in §B(2) of this regulation, the registered nurse shall complete a Board-approved course to be eligible for renewal of the RN-WCCM certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Notice to Workers' Compensation Commission."> <text>The Board shall:</text> <paragraph num="A."> <text>Notify the Commission of:</text> <paragraph num="(1)"> <text>The status of any RN-WCCM regulated under this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Any RN-WCCM who fails to renew their certification; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide the Commission quarterly reports of disciplinary actions taken against any licensee governed by this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Scope of Practice."> <paragraph num="A."> <text>The RN-WCCM may perform medical case management of the injured worker as defined in this chapter.</text> </paragraph> <paragraph num="B."> <text>The RN-WCCM shall comply with all:</text> <paragraph num="(1)"> <text>Other statutes or regulations governing registered nurse practice; and</text> </paragraph> <paragraph num="(2)"> <text>Laws, statutory policies, and procedures of the Commission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The RN-WCCM shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Course Approval."> <paragraph num="A."> <text>Each provider shall:</text> <paragraph num="(1)"> <text>Submit a course proposal for approval before implementation and at least every 3 years thereafter; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain from the Board a curriculum checklist detailing the content to be included in the course.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All changes, additions, or deletions to the course shall be approved by the Board before implementation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Course Requirements."> <paragraph num="A."> <text>Each course shall have a minimum of 16 hours of theory content.</text> </paragraph> <paragraph num="B."> <text>The curriculum shall include the following content areas:</text> <paragraph num="(1)"> <text>An historical perspective of case management;</text> </paragraph> <paragraph num="(2)"> <text>Insurance terms and types of coverage—general;</text> </paragraph> <paragraph num="(3)"> <text>Federal and State insurance statutes and regulations governing workers' compensation;</text> </paragraph> <paragraph num="(4)"> <text>Stakeholders—roles, responsibilities, ethical considerations, and goals;</text> </paragraph> <paragraph num="(5)"> <text>Maryland Nurse Practice Act; and</text> </paragraph> <paragraph num="(6)"> <text>Case management, including:</text> <paragraph num="(a)"> <text>Assessment;</text> </paragraph> <paragraph num="(b)"> <text>Planning;</text> </paragraph> <paragraph num="(c)"> <text>Implementation;</text> </paragraph> <paragraph num="(d)"> <text>Evaluation;</text> </paragraph> <paragraph num="(e)"> <text>Written reporting; and</text> </paragraph> <paragraph num="(f)"> <text>Communication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The course offering shall use texts from a Board-approved list.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Faculty."> <paragraph num="A."> <text>Qualifications. Faculty shall hold a:</text> <paragraph num="(1)"> <text>Current license in Maryland to practice registered nursing or a multistate licensure privilege to practice registered nursing; and</text> </paragraph> <paragraph num="(2)"> <text>Certification as a case manager by a certifying body recognized by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Responsibilities. Faculty shall:</text> <paragraph num="(1)"> <text>Plan, implement, and evaluate the course at periodic planned intervals; and</text> </paragraph> <paragraph num="(2)"> <text>Develop and utilize written examinations to measure achievement of course objectives.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Unlawful Practice."> <paragraph num="A."> <text>Unless authorized to practice under this chapter, an individual may not use the words “registered nurse—workers' compensation medical case manager”, RN—WCCM, or any other words, letters, or symbols with the intent to represent that the individual is a registered nurse-workers' compensation medical case manager.</text> </paragraph> <paragraph num="B."> <text>An individual certified under this chapter is subject to disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>An individual may not practice medical case management for the Commission unless authorized under this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §§8-102 and 8-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted as an emergency provision effective August 2, 1999; adopted permanently effective November 15, 1999 (26:23 Md. R. 1777)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C adopted effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="17" heading="Teletherapy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all certified registered nurse practitioners/psychiatric mental health (CRNP/PMH) and psychiatric mental health/advanced practice registered nurses (PMH/APRN) in Maryland, with a specialty certification in psychiatric mental health, who will be providing behavioral health services using teletherapy.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certified registered nurse practitioner/psychiatric mental health (CRNP/PMH)” means a certified registered nurse practitioner who:</text> <paragraph num="(a)"> <text>Is certified by the Board as a certified registered nurse practitioner in the practice of psychiatric mental health; and</text> </paragraph> <paragraph num="(b)"> <text>Autonomously and independently engages in activities authorized by this chapter and in accordance with COMAR 10.27.07.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Psychiatric mental health/advanced practice registered nurse (PMH/APRN)” means an advanced practice registered nurse who:</text> <paragraph num="(a)"> <text>Is certified by the Board as a clinical nurse specialist in the practice of psychiatric mental health; and</text> </paragraph> <paragraph num="(b)"> <text>Autonomously and independently engages in activities authorized by this chapter and in accordance with COMAR 10.27.12.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Synchronous” means simultaneous or quick enough to allow two or more individuals to interact.</text> </paragraph> <paragraph num="(4)"> <text>Teletherapy.</text> <paragraph num="(a)"> <text>“Teletherapy” means the delivery of behavioral health services by a CRNP/PMH or a PMH/APRN at a location other than the location of the client through the use of synchronous interactive audio, video, audio-visual, or other telecommunications or electronic technology.</text> </paragraph> <paragraph num="(b)"> <text>“Teletherapy” does not include:</text> <paragraph num="(i)"> <text>An audio-only telephone conversation between the CRNP/PMH or PMH/APRN and a client;</text> </paragraph> <paragraph num="(ii)"> <text>An electronic mail message between a CRNP/PMH or PMH/ APRN and a client; or</text> </paragraph> <paragraph num="(iii)"> <text>A facsimile transmission between a CRNP/PMH or PMH/APRN and a client.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>An individual shall be licensed as a registered nurse in Maryland, or have an active multistate licensure privilege to practice as a registered nurse in Maryland, and be certified by the Board as a CRNP/PMH or PMH/APRN in order to provide teletherapy services in Maryland if either the client or the CRNP/PMH or PMH/APRN is physically located in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Teletherapy."> <paragraph num="A."> <text>In order to provide teletherapy services to a client, a CRNP/PMH or PMH/APRN shall have:</text> <paragraph num="(1)"> <text>Established a client-therapist relationship;</text> </paragraph> <paragraph num="(2)"> <text>Performed a mental status assessment;</text> </paragraph> <paragraph num="(3)"> <text>Established a diagnosis;</text> </paragraph> <paragraph num="(4)"> <text>Developed a treatment plan; and</text> </paragraph> <paragraph num="(5)"> <text>Obtained an informed consent from the client to provide teletherapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before providing teletherapy services, the CRNP/PMH or PMH/APRN shall develop a procedure to:</text> <paragraph num="(1)"> <text>Verify the identity of the client receiving teletherapy services;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that all medical records are protected from unauthorized access through encryption or other means;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the CRNP/PMH or PMH/APRN provides a secure and private teletherapy connection and complies with federal and state privacy laws;</text> </paragraph> <paragraph num="(4)"> <text>Notify a client in the event of a data breach in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and the Maryland Confidentiality of Medical Records Act; and</text> </paragraph> <paragraph num="(5)"> <text>Establish safety protocols to be used in the case of an emergency.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At the outset of each teletherapy session, the CRNP/PMH or PMH/APRN shall:</text> <paragraph num="(1)"> <text>Identify all individuals present at each location and confirm that they are permitted to hear or access personal health information;</text> </paragraph> <paragraph num="(2)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure; and</text> </paragraph> <paragraph num="(3)"> <text>Determine whether the client is in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards of Practice."> <paragraph num="A."> <text>A CRNP/PMH or PMH/APRN providing teletherapy services shall be held to the same standards of practice and documentation as those applicable in in-person health care settings.</text> </paragraph> <paragraph num="B."> <text>A CRNP/PMH or PMH/APRN may not treat a patient or prescribe medication based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Discipline."> <paragraph num="A."> <text>The Board shall use the same standards in evaluating and investigating a complaint and disciplining a CRNP/PMH or PMH/APRN who provides teletherapy as it would use for a CRNP/PMH or PMH/APRN who is not.</text> </paragraph> <paragraph num="B."> <text>A CRNP/PMH or PMH/APRN who provides teletherapy services and fails to comply with this chapter may be subject to discipline under Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-901, 1-902, and 8-205(a)(2)—(5), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 29, 2019 (46:15 Md. R. 655)</annotation> </annotations> </chapter> <chapter num="18" heading="Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of monetary penalties not exceeding $5,000 against a registered nurse, licensed practical nurse, direct-entry midwife, licensed certified midwife, or advanced practice registered nurse if the Board finds that there are grounds to take action under Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means, unless the context requires otherwise, a:</text> <paragraph num="(a)"> <text>Registered nurse, a licensed practical nurse, or an advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A licensed direct-entry midwife as defined in Health Occupations Article, §8-6C-01, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>A licensed certified midwife as defined in Health Occupations Article, §8-6D-01, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Penalty” means monetary fine.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of Penalty Generally."> <paragraph num="A."> <text>The Board may impose a penalty against a licensee if the Board finds that there are grounds to take action against the licensee pursuant to Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The penalty in §A of this regulation may be imposed instead of or in addition to suspending or revoking the license, reprimanding the licensee, or placing the licensee on probation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Imposition of Penalties on Licensees."> <paragraph num="A."> <text>A penalty of not less than $100 or more than $1,000 may be imposed by the Board on a licensee if found guilty of any of the following:</text> <paragraph num="(1)"> <text>Filing a false report or record of an individual under the licensee's care;</text> </paragraph> <paragraph num="(2)"> <text>Giving any false or misleading information about a material matter in an employment application;</text> </paragraph> <paragraph num="(3)"> <text>Failing to file or record any health record that is required by law;</text> </paragraph> <paragraph num="(4)"> <text>Obstructing the filing or recording of any health record as required by law;</text> </paragraph> <paragraph num="(5)"> <text>Inducing another individual to fail to file or record any health record as required by law;</text> </paragraph> <paragraph num="(6)"> <text>Violating any provision of Health Occupations Article, §8-316, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Submitting a false statement to collect a fee;</text> </paragraph> <paragraph num="(8)"> <text>Being professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(9)"> <text>Providing professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol, or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(11)"> <text>Refusing, withholding, denying, or discriminating against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render care because the individual is HIV positive;</text> </paragraph> <paragraph num="(12)"> <text>Except in an emergency life-threatening situation where it is not feasible or practicable, failing to comply with the guidelines on universal precautions which are incorporated by reference in COMAR 10.06.01.02B(13);</text> </paragraph> <paragraph num="(13)"> <text>Being in independent practice and failing to display the notice required under Health Occupations Article, §8-506, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(14)"> <text>Failing to begin to fulfill a public service requirement within 1 year of when the assignment is to begin that was a condition of the applicant or licensee receiving State or federal loans or scholarships for the applicant's or licensee's nursing education; or</text> </paragraph> <paragraph num="(15)"> <text>Being expelled from the Safe Practice Program established pursuant to Health Occupations Article, §8-208, Annotated Code of Maryland, for failure to comply with the conditions of the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Violation of Probation. A penalty of $100 per violation may be imposed by the Board on a licensee who fails to comply with the conditions of probation.</text> </paragraph> <paragraph num="C."> <text>A penalty of not less than $1,000 or more than $5,000 may be imposed by the Board on a licensee found guilty of any of the following:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively using a license;</text> </paragraph> <paragraph num="(3)"> <text>Being disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes;</text> </paragraph> <paragraph num="(4)"> <text>Being convicted of or pleading guilty or nolo contendere to a felony or to a crime involving moral turpitude whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may impose a penalty of not less than $500 or more than $5,000 upon a licensee found guilty of knowingly doing any act that has been determined by the Board, in the Board's regulations, to exceed the scope of practice authorized to the individual under this title when the violation is:</text> <paragraph num="(1)"> <text>Determined to be willful or actual harm results, or both, the penalty may range from $500 to $5,000;</text> </paragraph> <paragraph num="(2)"> <text>Determined to be willful and there is potential harm to the public, the penalty may range from $500 to $2,000;</text> </paragraph> <paragraph num="(3)"> <text>Determined to be negligent or actual harm results, or both, the penalty may range from $500 to $5,000;</text> </paragraph> <paragraph num="(4)"> <text>Determined to be negligent and there is potential harm to the public, the penalty may range from $500 to $2,000; and</text> </paragraph> <paragraph num="(5)"> <text>A repeat offense, the penalty may be double the amount for the category of offense described in this section, not to exceed $5,000.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A penalty of up to $1,000 per violation may be imposed by the Board on a licensee who knowingly abuses a patient without causing patient harm.</text> </paragraph> <paragraph num="F."> <text>A penalty of up to $5,000 per violation may be imposed by the Board on a licensee who knowingly abuses a patient and causes patient harm.</text> </paragraph> <paragraph num="G."> <text>Fines other than those stated above may be imposed at the discretion of the Board.</text> </paragraph> <paragraph num="H."> <text>Failure to Renew.</text> <paragraph num="(1)"> <text>The Board may impose the following penalties on a licensee for failure to renew licensure:</text> <paragraph num="(a)"> <text>Not less than $150 per month for practicing on a non-renewed license for a period of up to 1 year; or</text> </paragraph> <paragraph num="(b)"> <text>Amount to be determined by the Board for practicing nursing with a license that was non-renewed for a period of more than 1 year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A penalty of up to $5,000 may be imposed by the Board on a director of nursing found guilty of employing nurses with lapsed licenses on two or more occasions within 1 year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Payment of Monetary Penalties."> <paragraph num="A."> <text>The licensee shall pay all fines by cashier's check or money order made payable to the Board and delivered personally or by certified mail to the Board within 60 days of the date of the order.</text> </paragraph> <paragraph num="B."> <text>The Board shall pay all monies collected by the Board pursuant to these regulations into the general fund of the State.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-316, 8-6C-20, and 8–6D–10, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 10, 1995 (22:7 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, H amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="19" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abandonment.</text> <paragraph num="(a)"> <text>“Abandonment” means:</text> <paragraph num="(i)"> <text>Termination by a nurse of a client assignment which had been accepted by the nurse, without reasonable notification to the immediate supervisor to allow for the continuation of the client’s care;</text> </paragraph> <paragraph num="(ii)"> <text>In the case of a natural disaster or a federal, State, county, or city declaration of an emergency, refusal by a nurse of an assignment, mandatory overtime, or both; or</text> </paragraph> <paragraph num="(iii)"> <text>In the case of a private duty assignment or hospice, if the nurse is the sole provider of care, failure to report for assigned duty or leaving the client unattended at the end of the assigned shift without prior notification to the nursing supervisor, the cognitive capable adult client, or the client’s designated representative.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Abandonment” does not include the declining by a nurse of employer-stipulated mandatory overtime.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Accepting a client assignment” means a nurse has arrived on duty and assumed responsibility for client care based on the nurse’s reasonable and prudent professional judgment and the standards of nursing practice.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Client” means a patient, resident, or recipient of care.</text> </paragraph> <paragraph num="(5)"> <text>“Electronic devices” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephones with recording and picture-taking ability;</text> </paragraph> <paragraph num="(b)"> <text>Digital cameras or any other device that can record pictures and data;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machines, photocopiers, and scanners for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Recording devices.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(7)"> <text>“Nurse” means a registered nurse, licensed practical nurse, or advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Social media” means any form of electronic communication, including, but not limited to, communication by use of websites for social networking and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Responsibilities."> <paragraph num="A."> <text>A nurse shall:</text> <paragraph num="(1)"> <text>Provide services with respect for human dignity and the uniqueness of a client unrestricted by consideration of social or economic status, religious affiliation, personal attributes, or the nature of health problems;</text> </paragraph> <paragraph num="(2)"> <text>Safeguard a client's right to privacy by maintaining confidentiality of information;</text> </paragraph> <paragraph num="(3)"> <text>Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any person;</text> </paragraph> <paragraph num="(4)"> <text>Promptly report a breach of confidentiality or privacy;</text> </paragraph> <paragraph num="(5)"> <text>Assume responsibility and accountability for individual nursing judgments and actions;</text> </paragraph> <paragraph num="(6)"> <text>Maintain competence in nursing;</text> </paragraph> <paragraph num="(7)"> <text>Exercise informed judgment and use individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and delegating nursing activities to others; and</text> </paragraph> <paragraph num="(8)"> <text>Inform the Board regarding unethical conduct by another licensed nurse.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse may not, when acting in the capacity or identity of a licensed nurse:</text> <paragraph num="(1)"> <text>Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(3)"> <text>Perform new techniques and procedures without adequate education and practice;</text> </paragraph> <paragraph num="(4)"> <text>Assume duties and responsibilities in the practice of nursing without adequate preparation or without maintaining competency;</text> </paragraph> <paragraph num="(5)"> <text>Practice nursing if unfit to perform procedures or make decisions because of physical or mental impairment, including, but not limited to, the effects of prescription drugs;</text> </paragraph> <paragraph num="(6)"> <text>If engaged in research, coerce or pressure a subject to participate or continue to participate in the research; or</text> </paragraph> <paragraph num="(7)"> <text>Abandon a client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A nurse may not engage in behavior that dishonors the profession whether or not acting in the capacity or identity of a licensed nurse, including, but not limited to:</text> <paragraph num="(1)"> <text>Verbal abuse, including use of racial or ethnic slurs, directed toward a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(2)"> <text>Physically abusing, threatening, or intimidating a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(3)"> <text>Deceiving, defrauding, or stealing from a coworker, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(4)"> <text>Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication;</text> </paragraph> <paragraph num="(5)"> <text>Knowingly employing another person to practice or engage in or attempt to practice or engage in an occupation or profession licensed under this title if the employee is not licensed to do so under Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Performing acts beyond the authorized scope of the level of nursing practice for which the individual is licensed;</text> </paragraph> <paragraph num="(7)"> <text>Obtaining or copying any part of a client’s health record for purposes other than:</text> <paragraph num="(a)"> <text>Providing health care to the client;</text> </paragraph> <paragraph num="(b)"> <text>Conducting quality improvement activities;</text> </paragraph> <paragraph num="(c)"> <text>Complying with legal requirements such as a subpoena; or</text> </paragraph> <paragraph num="(d)"> <text>Allowing a nursing student to use records for educational purposes if client identification has been redacted or disguised;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid medical indication;</text> </paragraph> <paragraph num="(9)"> <text>Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample;</text> </paragraph> <paragraph num="(10)"> <text>Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug;</text> </paragraph> <paragraph num="(11)"> <text>Using the power, influence, or knowledge, inherent in or obtained during the nurse-patient relationship, for the nurse’s personal gratification or benefit;</text> </paragraph> <paragraph num="(12)"> <text>Engaging in unprofessional or immoral conduct;</text> </paragraph> <paragraph num="(13)"> <text>Misrepresenting or concealing a material fact in obtaining a license, renewing a license, or reinstating a license; or</text> </paragraph> <paragraph num="(14)"> <text>Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A nurse may not engage in sexual misconduct. Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client;</text> </paragraph> <paragraph num="(4)"> <text>Sexual advances toward, or the request of sexual favors from, a coworker, student, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(5)"> <text>Discussion of nontherapeutic sexual matters while treating a client;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs of a client for a sexual purpose;</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of a coworker, student, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(8)"> <text>Sexual contact with an incompetent or unconscious client;</text> </paragraph> <paragraph num="(9)"> <text>Intentionally exposing any of the nurse's sexual body parts; and</text> </paragraph> <paragraph num="(10)"> <text>Intentionally exposing any of the client’s sexual body parts for a nontherapeutic purpose.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Electronic devices, including but not limited to telephones, may not be used to record medical records and take pictures or videos of clients without written client authorization.</text> </paragraph> <paragraph num="F."> <text>A nurse:</text> <paragraph num="(1)"> <text>May not make use of electronic devices and social media to transmit or place any client information online; and</text> </paragraph> <paragraph num="(2)"> <text>Shall adhere to the following principles for the use of electronic devices and social media:</text> <paragraph num="(a)"> <text>Every nurse has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking;</text> </paragraph> <paragraph num="(b)"> <text>Nurses are bound to observe ethically prescribed client-nurse boundaries online as in any other setting;</text> </paragraph> <paragraph num="(c)"> <text>Client information shall be maintained in separate encrypted and secured files on personal computers and online;</text> </paragraph> <paragraph num="(d)"> <text>A nurse has an obligation to report any electronically generated material that could harm a client’s privacy rights; and</text> </paragraph> <paragraph num="(e)"> <text>The standards of professionalism are the same when using electronic devices and social media as in any other circumstance.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of this chapter may result in the Board taking disciplinary action against a nurse pursuant to Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-316(a)(25), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1996 (23:13 Md. R. 944)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed and new Regulations .01—.03 adopted effective September 16, 2002 (29:18 Md. R. 1443)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 11, 2014 (41:24 Md. R. 1428); July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 11, 2014 (41:24 Md. R. 1428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="20" heading="Management of Infusion Therapy by the Registered Nurse and the Licensed Practical Nurse"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <text>This chapter is not applicable to, and does not restrict or limit, other health care practitioners who are authorized to perform these duties under their respective laws.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administer” means to hang or give subsequent fluids and medications.</text> </paragraph> <paragraph num="(2)"> <text>“Antineoplastic” means:</text> <paragraph num="(a)"> <text>Chemical or biologic agents that have a toxic effect on the disease-causing agent or modify the host environment; or</text> </paragraph> <paragraph num="(b)"> <text>Drugs that are capable of destroying invading organisms or malignant tumor cells.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Arterial catheter” means a catheter or needle inserted into an artery.</text> </paragraph> <paragraph num="(4)"> <text>“Assign” means to designate another licensee to be responsible and accountable to perform nursing acts that are within the licensee's scope of practice, knowledge, judgment, and skill.</text> </paragraph> <paragraph num="(5)"> <text>“Central venous catheter (CVC)” means a catheter whose tip is located in a central vessel.</text> </paragraph> <paragraph num="(6)"> <text>“Chronic dialysis client” means a client with end stage renal disease who is receiving routine dialysis treatments in an outpatient facility.</text> </paragraph> <paragraph num="(7)"> <text>“Clinical competence” means the demonstrated ability to perform the identified IV tasks consistent with the standards established by the INS, ONS, or other bodies approved by the Board.</text> </paragraph> <paragraph num="(8)"> <text>“Comprehensive assessment” means a nursing assessment that includes:</text> <paragraph num="(a)"> <text>The specific individual patient's clinical status;</text> </paragraph> <paragraph num="(b)"> <text>Medical treatment regime; and</text> </paragraph> <paragraph num="(c)"> <text>Complexity of the infusion therapy treatment regime including:</text> <paragraph num="(i)"> <text>The purpose and effects of the specific infusate or medication;</text> </paragraph> <paragraph num="(ii)"> <text>Skills to access and de-access the infusion catheter access device; and</text> </paragraph> <paragraph num="(iii)"> <text>The potential harm to the patient should an error occur.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>Direct Supervision.</text> <paragraph num="(a)"> <text>“Direct supervision” means oversight exercised by a registered nurse who is present on the unit of care during the infusion therapy process.</text> </paragraph> <paragraph num="(b)"> <text>“Direct supervision” includes the actions of:</text> <paragraph num="(i)"> <text>Observation;</text> </paragraph> <paragraph num="(ii)"> <text>Assessment;</text> </paragraph> <paragraph num="(iii)"> <text>Evaluation; and</text> </paragraph> <paragraph num="(iv)"> <text>Direction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“First dose” has the meaning defined by the facility's policies and procedures.</text> </paragraph> <paragraph num="(11)"> <text>“Hypodermoclysis” means the infusion of fluids into subcutaneous tissue for hydration.</text> </paragraph> <paragraph num="(12)"> <text>Implanted Port.</text> <paragraph num="(a)"> <text>“Implanted port” means a reservoir surgically placed under the skin and attached to a catheter which is placed in a vessel, body cavity, or organ.</text> </paragraph> <paragraph num="(b)"> <text>“Implanted port” is often referred to as a medi-port, port-a-cath, infuse-a-port, infusion port, or a subcutaneous port.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Implanted pump” means a catheter surgically placed into a vessel, body cavity, or body space, and attached to a reservoir placed under the skin, that contains a pumping mechanism for continuous medication administration.</text> </paragraph> <paragraph num="(14)"> <text>“Infusion therapy” means the initiation and administration of medication, fluids, and nutrients via an intravenous access device.</text> </paragraph> <paragraph num="(15)"> <text>“Initiate” means to hang and administer the first dose of medications or fluids.</text> </paragraph> <paragraph num="(16)"> <text>“INS” means Infusion Nurses Society.</text> </paragraph> <paragraph num="(17)"> <text>“Intraventricular reservoir” means a catheter threaded through the dura into a ventricle of the brain.</text> </paragraph> <paragraph num="(18)"> <text>“Licensee” means a registered nurse or licensed practical nurse.</text> </paragraph> <paragraph num="(19)"> <text>“LPN” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice licensed practical nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Midclavicular catheter” means a peripherally inserted catheter with the distal tip located between the axilla and the vena cava.</text> </paragraph> <paragraph num="(21)"> <text>“Midline catheter” means a peripherally inserted catheter with the tip terminating below the axilla.</text> </paragraph> <paragraph num="(22)"> <text>“Multi-lumen catheter” means a venous access device that has more than one lumen.</text> </paragraph> <paragraph num="(23)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(24)"> <text>“Non-tunneled catheter” means a percutaneously placed catheter inserted into the vein.</text> </paragraph> <paragraph num="(25)"> <text>“ONS” means Oncology Nursing Society.</text> </paragraph> <paragraph num="(26)"> <text>“On-site supervision” means oversight exercised by a supervising registered nurse who is:</text> <paragraph num="(a)"> <text>Present in the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Quickly and easily available to the patient and the assigned nurse during the course of infusion therapy.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Peripheral catheter” means a catheter or needle inserted into a superficial vein with the tip residing outside of the central venous system.</text> </paragraph> <paragraph num="(28)"> <text>“Peripheral veins” means those veins in the superficial aspects of the body excluding the external jugular vein.</text> </paragraph> <paragraph num="(29)"> <text>“Peripherally inserted central catheter (PICC)” means a catheter, inserted with or without a guide wire, whose tip is located in the vena cava.</text> </paragraph> <paragraph num="(30)"> <text>“PPN” means partial parenteral nutrition.</text> </paragraph> <paragraph num="(31)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Specialized catheter” means an epidural, intrathecal, intrapleural, or peripheral nerve catheter.</text> </paragraph> <paragraph num="(33)"> <text>“Subcutaneous infusion of medication” means a continuous or intermittent infusion of medication by an indwelling needle or catheter inserted into subcutaneous tissue.</text> </paragraph> <paragraph num="(34)"> <text>“TPN” means total parenteral nutrition administered into the central venous system.</text> </paragraph> <paragraph num="(35)"> <text>“Tunneled catheter” means a CVC designed to have a portion of the catheter lie in a subcutaneous passage before exiting the body.</text> </paragraph> <paragraph num="(36)"> <text>“Nonsurgically placed” means a catheter placed percutaneously.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Education."> <text>To perform infusion therapy, the licensee shall:</text> <paragraph num="A."> <text>Complete an infusion therapy program of study which contains didactic content and a clinical practicum consistent with the standards of practice established by the INS or other bodies approved by the Board that includes but is not limited to:</text> <paragraph num="(1)"> <text>Infusion access devices;</text> </paragraph> <paragraph num="(2)"> <text>Selected infusates, blood, and blood components;</text> </paragraph> <paragraph num="(3)"> <text>Nursing assessment and monitoring skills required for the infusion therapy acts to be performed;</text> </paragraph> <paragraph num="(4)"> <text>Management of complications related to the infusion therapy and access devices; and</text> </paragraph> <paragraph num="(5)"> <text>Delivery devices;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have documented evidence of clinical competency before independently:</text> <paragraph num="(1)"> <text>Inserting infusion devices; or</text> </paragraph> <paragraph num="(2)"> <text>Managing the care of patients receiving infusion therapy;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Perform the infusion therapy acts on a frequent routine predictable basis in order to retain practice proficiency;</text> </paragraph> <paragraph num="D."> <text>Be evaluated for continued clinical competency at planned periodic time intervals; and</text> </paragraph> <paragraph num="E."> <text>Obtain additional education on nursing assessment and monitoring when the patient population changes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Infusion Therapy Acts — General."> <paragraph num="A."> <text>The licensee shall comply with the employer's written policies and procedures which are in compliance with this chapter regarding infusion therapy.</text> </paragraph> <paragraph num="B."> <text>The licensee shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Infusion Therapy Acts — LPN."> <paragraph num="A."> <text>The LPN may perform the following infusion therapy acts for peripheral and subcutaneous infusions when there is an RN on site or available by telephone:</text> <paragraph num="(1)"> <text>Calculate and adjust flow rate including pumps;</text> </paragraph> <paragraph num="(2)"> <text>Observe and report on:</text> <paragraph num="(a)"> <text>Insertion site; and</text> </paragraph> <paragraph num="(b)"> <text>Objective and subjective signs of adverse reactions to infusion therapy;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Change the dressing on the insertion site;</text> </paragraph> <paragraph num="(4)"> <text>Change the administration set;</text> </paragraph> <paragraph num="(5)"> <text>Insert subcutaneous needle or catheter to:</text> <paragraph num="(a)"> <text>Rotate sites for an existing infusion; and</text> </paragraph> <paragraph num="(b)"> <text>Administer a medication which is routine for the patient;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Insert a peripheral IV needle or catheter (excluding midline) to:</text> <paragraph num="(a)"> <text>Withdraw a blood specimen; or</text> </paragraph> <paragraph num="(b)"> <text>Initiate IV fluids;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Remove a peripheral and subcutaneous IV needle or catheter;</text> </paragraph> <paragraph num="(8)"> <text>Flush a peripheral and midline IV device;</text> </paragraph> <paragraph num="(9)"> <text>Convert an existing continuous infusion to an intermittent infusion;</text> </paragraph> <paragraph num="(10)"> <text>Convert an intermittent infusion to a continuous infusion;</text> </paragraph> <paragraph num="(11)"> <text>Change injection cap;</text> </paragraph> <paragraph num="(12)"> <text>Insert device and initiate hypodermoclysis and add replacement solutions; and</text> </paragraph> <paragraph num="(13)"> <text>Administer medication via a peripheral IV line (including midline) using:</text> <paragraph num="(a)"> <text>Pharmacy-prepared medication; and</text> </paragraph> <paragraph num="(b)"> <text>PPN solutions; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Add medications to an intravenous solution.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The LPN may perform the following acts for midclavicular, CVC, PICC, and implanted ports:</text> <paragraph num="(1)"> <text>Calculate and adjust flow rate including a pump;</text> </paragraph> <paragraph num="(2)"> <text>Observe and report on:</text> <paragraph num="(a)"> <text>The insertion site; and</text> </paragraph> <paragraph num="(b)"> <text>Objective and subjective signs of adverse reactions to infusion therapy;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Change the dressing on the insertion site;</text> </paragraph> <paragraph num="(4)"> <text>Flush a midclavicular, PICC, CVC, and an accessed implanted port;</text> </paragraph> <paragraph num="(5)"> <text>Change injection cap;</text> </paragraph> <paragraph num="(6)"> <text>Change administration sets;</text> </paragraph> <paragraph num="(7)"> <text>Convert an existing continuous infusion to an intermittent infusion; and</text> </paragraph> <paragraph num="(8)"> <text>Convert an intermittent infusion to a continuous infusion.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The LPN may perform the following additional acts under the direct supervision of the RN following a comprehensive patient assessment:</text> <paragraph num="(1)"> <text>Administer TPN via PICC, implanted ports, or CVC;</text> </paragraph> <paragraph num="(2)"> <text>Administer medications by midclavicular, PICC, CVC, and implanted ports by hanging pharmacy prepared solutions;</text> </paragraph> <paragraph num="(3)"> <text>Add medication to a solution administered via PICC, midclavicular CVC, and implanted ports;</text> </paragraph> <paragraph num="(4)"> <text>Observe, monitor, and report on the patient:</text> <paragraph num="(a)"> <text>With specialized catheters; and</text> </paragraph> <paragraph num="(b)"> <text>During a blood transfusion;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Initiate and administer blood and blood components;</text> </paragraph> <paragraph num="(6)"> <text>Draw blood specimens via midline, PICC, CVC, and implanted ports;</text> </paragraph> <paragraph num="(7)"> <text>Access and de-access implanted ports; and</text> </paragraph> <paragraph num="(8)"> <text>Initiate the first dose of a medication after it has been reviewed and evaluated for potential risk by the RN.</text> </paragraph> </paragraph> <paragraph num="D."> <text>On completion of a second specialized educational program in infusion therapy, containing didactic content and a clinical practicum, consistent with the standards of ONS or other bodies approved by the Board and with documented evidence of clinical competency, the LPN may administer standardized doses of non-vesicant chemotherapeutic agents and antiviral agents to an existing infusion in accord with the facility's written protocol or practice guidelines. The LPN shall perform these additional procedures under the direct supervision of the RN following a comprehensive patient assessment.</text> </paragraph> <paragraph num="E."> <text>The LPN may perform additional infusion therapy acts in a licensed outpatient dialysis facility serving the chronic dialysis client when:</text> <paragraph num="(1)"> <text>The requirements of Regulations .03 and .04 of this chapter and §§A—C of this regulation have been met;</text> </paragraph> <paragraph num="(2)"> <text>The outpatient dialysis unit RN skilled in chronic dialysis has taught a didactic and clinical practicum for the LPN which includes but is not limited to:</text> <paragraph num="(a)"> <text>Pharmacological interventions specific to:</text> <paragraph num="(i)"> <text>Physiological alterations and effects of chronic renal failure;</text> </paragraph> <paragraph num="(ii)"> <text>Indication, dosage, side effects, and contraindications of each drug intervention; and</text> </paragraph> <paragraph num="(iii)"> <text>Special considerations of each drug intervention specific to the chronic renal failure client; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Route of medication administration and access delivery systems;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The outpatient dialysis RN documents evidence of the LPN's clinical competency of the additional activities under §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The LPN may perform the following additional infusion acts, that may include the flushing of catheters, in a licensed outpatient dialysis facility serving the chronic dialysis client under the direct supervision of the RN skilled in chronic dialysis:</text> <paragraph num="(1)"> <text>Venipuncture for the purpose of hemodialysis;</text> </paragraph> <paragraph num="(2)"> <text>Initiation of and discontinuation from dialysis utilizing the various accesses, including:</text> <paragraph num="(a)"> <text>Subclavian catheters;</text> </paragraph> <paragraph num="(b)"> <text>Internal jugular catheters;</text> </paragraph> <paragraph num="(c)"> <text>Femoral vein catheters;</text> </paragraph> <paragraph num="(d)"> <text>Arterial catheters;</text> </paragraph> <paragraph num="(e)"> <text>Fistulas; and</text> </paragraph> <paragraph num="(f)"> <text>Grafts;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Withdrawal of blood and heparinized saline from the various accesses for the purpose of removing the heparin and establishing patency;</text> </paragraph> <paragraph num="(4)"> <text>Withdrawal of blood from access for the purpose of obtaining blood for a laboratory specimen;</text> </paragraph> <paragraph num="(5)"> <text>Administration of IV medications and solutions during hemodialysis;</text> </paragraph> <paragraph num="(6)"> <text>Performance of dressing changes to various access device sites; and</text> </paragraph> <paragraph num="(7)"> <text>Administration of the following medications by IV “push” per physician order and nationally recognized standards of care:</text> <paragraph num="(a)"> <text>Anticoagulant agents;</text> </paragraph> <paragraph num="(b)"> <text>Saline;</text> </paragraph> <paragraph num="(c)"> <text>Erythropoeitic agents;</text> </paragraph> <paragraph num="(d)"> <text>Vitamin D products;</text> </paragraph> <paragraph num="(e)"> <text>Iron preparation agents; and</text> </paragraph> <paragraph num="(f)"> <text>Anti-emetic agents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The LPN may not perform the following acts:</text> <paragraph num="(1)"> <text>Administer medication via IV “push”, except as set forth in §F(7) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Insert a midline catheter;</text> </paragraph> <paragraph num="(3)"> <text>De-clot the catheter;</text> </paragraph> <paragraph num="(4)"> <text>Repair a catheter;</text> </paragraph> <paragraph num="(5)"> <text>Insert and remove PICC, midline catheters, and midclavicular catheters;</text> </paragraph> <paragraph num="(6)"> <text>Manage specialized catheters for analgesia; and</text> </paragraph> <paragraph num="(7)"> <text>Remove nonsurgically placed central and arterial catheters.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Infusion Therapy Acts — RN."> <paragraph num="A."> <text>In addition to all previously identified procedures in Regulations .04 and .05A—C of this chapter, the RN may perform the following procedures:</text> <paragraph num="(1)"> <text>Administer medication via IV “push”;</text> </paragraph> <paragraph num="(2)"> <text>Initiate subcutaneous infusion of medication; and</text> </paragraph> <paragraph num="(3)"> <text>Provide care and manage arterial catheters and arterial ports by:</text> <paragraph num="(a)"> <text>Changing IV administration set;</text> </paragraph> <paragraph num="(b)"> <text>Flushing or aspirating;</text> </paragraph> <paragraph num="(c)"> <text>Changing dressing;</text> </paragraph> <paragraph num="(d)"> <text>Obtaining blood specimens;</text> </paragraph> <paragraph num="(e)"> <text>Accessing and de-accessing; and</text> </paragraph> <paragraph num="(f)"> <text>Changing injection cap.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The RN, upon completion of a second specialized educational program in infusion therapy which includes didactic content and a clinical practicum consistent with the standards established by the ONS or other bodies approved by the Board and with documented evidence of clinical competency, may perform the following additional infusion therapy activities:</text> <paragraph num="(1)"> <text>Administer antineoplastic agents;</text> </paragraph> <paragraph num="(2)"> <text>Aspirate fluid from an intraventricular reservoir;</text> </paragraph> <paragraph num="(3)"> <text>Administer fluids and medications via an intraventricular reservoir;</text> </paragraph> <paragraph num="(4)"> <text>Manage implantable pumps by programming and filling with fluids and medications;</text> </paragraph> <paragraph num="(5)"> <text>Insert, repair, and remove PICC and midclavicular catheters;</text> </paragraph> <paragraph num="(6)"> <text>Insert and remove midline catheters;</text> </paragraph> <paragraph num="(7)"> <text>Manage specialized catheters for analgesia;</text> </paragraph> <paragraph num="(8)"> <text>Remove nonsurgically placed central and arterial catheters;</text> </paragraph> <paragraph num="(9)"> <text>Administer pharmacological agents to de-clot or restore blood return; and</text> </paragraph> <paragraph num="(10)"> <text>Repair a catheter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The RN may not perform the following acts:</text> <paragraph num="(1)"> <text>Administer the initial dose of any medication by intrathecal, epidural, intrapleural, or peripheral nerve catheter; or</text> </paragraph> <paragraph num="(2)"> <text>Remove any tunneled catheter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §8-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed and new Regulations .01—.06 adopted effective November 15, 1999 (26:23 Md. R. 1777)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 27, 2003 (30:21 Md. R. 1529); July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667); October 13, 2025 (52:10 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 27, 2003 (30:21 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 27, 2003 (30:21 Md. R. 1529)</annotation> </annotations> </chapter> <chapter num="21" heading="Registered Nurse — Forensic Nurse Examiner"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <text>This chapter is not applicable to and does not restrict or limit:</text> <paragraph num="A."> <text>Other health care practitioners who are authorized to perform these duties under the Maryland Health Occupations Article; or</text> </paragraph> <paragraph num="B."> <text>A licensed practical or registered nurse from acting as a chaperone during a forensic examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Alternate light source (ALS)” means equipment that produces visible and invisible light at various wave lengths to enhance the visualization of evidence.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Chain of custody” means a written list identifying, without interruption or lapse, every individual having control or possession of specified items or evidence.</text> </paragraph> <paragraph num="(4)"> <text>“Chaperone” means an individual who does not perform any part of the forensic examination but is present during the course of that examination.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical preceptor” means an RN-FNE educator or physician who has credentials and experience in forensic examinations.</text> </paragraph> <paragraph num="(6)"> <text>“Education” means:</text> <paragraph num="(a)"> <text>Giving presentations, including mentored clinical presentations;</text> </paragraph> <paragraph num="(b)"> <text>Attending conferences or seminars;</text> </paragraph> <paragraph num="(c)"> <text>Completing accredited professional computerized or periodical learning modules; and</text> </paragraph> <paragraph num="(d)"> <text>Participating in the facility evaluation or audit process.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“FNE program” means a facility authorized by the Maryland Department of Health to provide forensic nursing services.</text> </paragraph> <paragraph num="(8)"> <text>“Forensic evidentiary examination” means an examination for the purpose of gathering, labeling, preserving, and handling evidence that includes, but is not limited to:</text> <paragraph num="(a)"> <text>Photographic and written descriptive documentation of the findings;</text> </paragraph> <paragraph num="(b)"> <text>A general health and assault history interview; and</text> </paragraph> <paragraph num="(c)"> <text>A physical assessment which may include, but is not limited to:</text> <paragraph num="(i)"> <text>Skin surface examination;</text> </paragraph> <paragraph num="(ii)"> <text>Oral examination;</text> </paragraph> <paragraph num="(iii)"> <text>Genital examination;</text> </paragraph> <paragraph num="(iv)"> <text>Anal examination; and</text> </paragraph> <paragraph num="(v)"> <text>Speculum vaginal examination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Gynecological Urological teaching associate (GUTA)” means an adult who is trained to teach techniques for performing gender-specific physical examination to health care trainees, using self as a demonstration and practice model with emphasis on teaching from the patient perspective.</text> </paragraph> <paragraph num="(10)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(11)"> <text>“Peer review” means a process by which an RN-FNE’s clinical examination and documentation is reviewed by one or more peers who are authorized to perform the duties of an RN-FNE.</text> </paragraph> <paragraph num="(12)"> <text>“Physician” means an individual licensed to practice medicine in this State.</text> </paragraph> <paragraph num="(13)"> <text>“Practice guideline” means a written documentation that details the standards of care and practice protocols the facility has established to guide the practice of the RN-FNE.</text> </paragraph> <paragraph num="(14)"> <text>“Program coordinator” means an RN-FNE designated by the facility to manage and oversee the FNE program.</text> </paragraph> <paragraph num="(15)"> <text>“Proper authority” means a representative of law enforcement, adult or child protective services, or the jurisdictional authority for a minor or mentally incapacitated individual.</text> </paragraph> <paragraph num="(16)"> <text>“Refresher course” means a curriculum that:</text> <paragraph num="(a)"> <text>Includes didactic and clinical education; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the practice requirements for reinstatement of certification as an RN-FNE.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Registered nurse” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“RN-FNE” means a registered nurse forensic nurse examiner certified by the Board.</text> </paragraph> <paragraph num="(19)"> <text>“RN-FNE Educator” means an individual who:</text> <paragraph num="(a)"> <text>Has a current:</text> <paragraph num="(i)"> <text>License to practice as a registered nurse in Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Multistate licensure privilege to practice registered nursing under the Nurse Licensure Compact; or</text> </paragraph> <paragraph num="(iii)"> <text>Certification to practice as an advanced practice registered nurse in Maryland; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is certified under this chapter as a:</text> <paragraph num="(i)"> <text>Registered Nurse Forensic Examiner — Adult (RN-FNE-A);</text> </paragraph> <paragraph num="(ii)"> <text>Registered Nurse Forensic Examiner — Pediatric (RN-FNE-P); or</text> </paragraph> <paragraph num="(iii)"> <text>Registered Nurse Forensic Examiner — Adult and Pediatric (RN-FNE-AP); and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is qualified to teach the theoretical and clinical portions of the RN-FNE training program.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“RN-FNE-A” means a registered nurse certified by the Board to practice as a forensic nurse examiner with respect to forensic examinations performed on adults and individuals 13 years old or older.</text> </paragraph> <paragraph num="(21)"> <text>“RN-FNE-P” means a forensic nurse examiner-pediatric who is certified by the Board to practice as a forensic nurse examiner with respect to examinations of children who are younger than 13 years old.</text> </paragraph> <paragraph num="(22)"> <text>“RN-FNE-AP” means a registered nurse certified by the Board to practice as a forensic nurse examiner with respect to examinations of individuals of all ages.</text> </paragraph> <paragraph num="(23)"> <text>“SAFE” means a registered nurse who was certified by the Board before December 13, 1999, as a sexual assault forensic examiner under this chapter.</text> </paragraph> <paragraph num="(24)"> <text>“SANE” means a registered nurse who has successfully completed a program which meets the Sexual Assault Nurse Examiner Standards of Practice established by the International Association of Forensic Nurses.</text> </paragraph> <paragraph num="(25)"> <text>“SANE-A” means a forensic nurse examiner certified by the International Association of Forensic Nurses (IAFN) to perform a forensic evidentiary examination on adults and individuals 13 years old or older.</text> </paragraph> <paragraph num="(26)"> <text>“SANE-P” means a forensic nurse examiner certified by the IAFN to perform a forensic evidentiary examination on children who are younger than 13 years of age.</text> </paragraph> <paragraph num="(27)"> <text>"Simulation” means the utilization of an adult anatomically correct manikin or a GUTA in the performance of a forensic evidentiary examination.</text> </paragraph> <paragraph num="(28)"> <text>“Training program” means the instructional process utilizing the standardized curriculum approved by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authorization to Practice."> <paragraph num="A."> <text>An individual may be certified as:</text> <paragraph num="(1)"> <text>A registered nurse forensic nurse examiner-adult (RN-FNE-A);</text> </paragraph> <paragraph num="(2)"> <text>A registered nurse forensic nurse examiner-pediatric (RN-FNE-P); or</text> </paragraph> <paragraph num="(3)"> <text>A registered nurse forensic nurse examiner-adult/pediatric (RN-FNE-AP).</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant applying for certification to practice as an RN-FNE-A, RN-FNE-P or RN-FNE-AP shall:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Hold a current license to practice as a registered nurse in Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Have a multistate licensure privilege to practice registered nursing;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have at least 18 months of continuous clinical experience as a registered nurse;</text> </paragraph> <paragraph num="(3)"> <text>Complete a training program that includes a standardized curriculum approved by the Board and designed for the RN-FNE-A;</text> </paragraph> <paragraph num="(4)"> <text>Complete in full the application for certification in the category selected; and</text> </paragraph> <paragraph num="(5)"> <text>Pay all fees established by the Board in COMAR 10.27.01.02.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements listed in §B of this regulation, an applicant applying for certification as an RN-FNE-P or RN-FNE-AP shall complete a training program that includes the following standardized curricula approved by the Board:</text> <paragraph num="(1)"> <text>The standardized curriculum designed for the RN-FNE-A; and</text> </paragraph> <paragraph num="(2)"> <text>The standardized curriculum designed for the RN-FNE-P.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A registered nurse who has been certified by the Board as a SAFE on or after December 13, 1999 may be certified to practice as an RN-FNE-A, RN-FNE-P, or RN-FNE-AP if the individual:</text> <paragraph num="(1)"> <text>Submits a form required by the Board attesting that the individual has:</text> <paragraph num="(a)"> <text>Served in the role of SAFE for 200 hours in the previous 12 months;</text> </paragraph> <paragraph num="(b)"> <text>Obtained a total of 8 education clock hours in forensic science or forensic nursing in the previous 12 months;</text> </paragraph> <paragraph num="(c)"> <text>Completed three sexual assault evidentiary examinations in the previous 12 months with respect to:</text> <paragraph num="(i)"> <text>Adults and individuals 13 years old or older if applying for RN-FNE-A;</text> </paragraph> <paragraph num="(ii)"> <text>Children who are younger than 13 years old if applying for RN-FNE-P; or</text> </paragraph> <paragraph num="(iii)"> <text>Each category, if applying for RN-FNE-AP, for a total of six examinations; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Complies with all other requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Maintain an up-to-date list of all RNs certified to practice as RN-FNEs in the State; and</text> </paragraph> <paragraph num="(2)"> <text>Include on the RN's license an indication that the licensee is certified to practice as an RN-FNE, and a designation of the RN-FNE's area of specialization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope and Standards of Practice."> <paragraph num="A."> <text>An RN-FNE may perform the following tasks and functions with respect to the age group for which the RN-FNE is certified under Regulation .03 of this chapter:</text> <paragraph num="(1)"> <text>Perform forensic evidentiary examinations on victims and alleged perpetrators in connection with physical, sexual, or domestic assaults, whether chronic or acute;</text> </paragraph> <paragraph num="(2)"> <text>Before the forensic evidentiary examination, obtain consent from the individual being examined, from the parent or guardian of a minor individual, or from the proper authority for photographing and evidence collection;</text> </paragraph> <paragraph num="(3)"> <text>Prepare and document the assault history interview;</text> </paragraph> <paragraph num="(4)"> <text>Perform the forensic evidentiary physical assessment, which may include use of an ALS;</text> </paragraph> <paragraph num="(5)"> <text>Complete the physical evidence kit provided by law enforcement;</text> </paragraph> <paragraph num="(6)"> <text>Gather, preserve, handle, document, and label forensic evidence, including but not limited to:</text> <paragraph num="(a)"> <text>Labeling evidence collection containers with the patient's identifying data per local jurisdiction requirements;</text> </paragraph> <paragraph num="(b)"> <text>Placing evidence in the evidence collection container and sealing the container;</text> </paragraph> <paragraph num="(c)"> <text>Signing the evidence collection container as the collector of the evidence;</text> </paragraph> <paragraph num="(d)"> <text>Taking photographs; and</text> </paragraph> <paragraph num="(e)"> <text>Obtaining swabs, smears, and hair and body fluid samples;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Maintain the chain of custody;</text> </paragraph> <paragraph num="(8)"> <text>Provide immediate health interventions using clinical practice guidelines;</text> </paragraph> <paragraph num="(9)"> <text>Obtain consultations and make referrals to health care personnel and community agencies;</text> </paragraph> <paragraph num="(10)"> <text>Provide immediate crisis intervention at the time of the examination;</text> </paragraph> <paragraph num="(11)"> <text>Provide discharge instructions;</text> </paragraph> <paragraph num="(12)"> <text>Participate in forensic proceedings including courtroom testimony;</text> </paragraph> <paragraph num="(13)"> <text>Interface with law enforcement officials, crime labs, and State attorney's offices; and</text> </paragraph> <paragraph num="(14)"> <text>Assist the licensed physician in performing a forensic evidentiary examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Clinical Practice Guidelines. An RN-FNE may practice only in a clinical setting in which clinical policy and practice guidelines:</text> <paragraph num="(1)"> <text>Have been approved by the facility's medical and nursing departments;</text> </paragraph> <paragraph num="(2)"> <text>Designate the availability of qualified physician resources;</text> </paragraph> <paragraph num="(3)"> <text>Identify the department in which an RN-FNE shall function; and</text> </paragraph> <paragraph num="(4)"> <text>Designate a program coordinator who has experience in forensic evidentiary examinations to administer the RN-FNE training program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program coordinator:</text> <paragraph num="(1)"> <text>Is responsible for obtaining Board approval of the curriculum before conducting a training program;</text> </paragraph> <paragraph num="(2)"> <text>Has responsibility for oversight and administration of the facility’s RN-FNE training program and the practice of the facility’s RN-FNEs;</text> </paragraph> <paragraph num="(3)"> <text>Verifies the qualifications and certifications of any RN-FNE practicing in the facility;</text> </paragraph> <paragraph num="(4)"> <text>Administers and manages the RN-FNE practice;</text> </paragraph> <paragraph num="(5)"> <text>Approves practice protocols and standards of care for RN-FNE practice;</text> </paragraph> <paragraph num="(6)"> <text>Shall develop a peer review process that includes, but is not limited to:</text> <paragraph num="(a)"> <text>Coordinating the peer review of cases;</text> </paragraph> <paragraph num="(b)"> <text>Ensuring that the peer review is consistent with the standardized data collection process;</text> </paragraph> <paragraph num="(c)"> <text>Ensuring that a peer reviewer meets the qualifications in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Using the standardized form for peer review that is required by the Board;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Interfaces with law enforcement, the State's attorney, and community resource groups;</text> </paragraph> <paragraph num="(8)"> <text>Implements the facility's Board-approved RN-FNE curricula; and</text> </paragraph> <paragraph num="(9)"> <text>Facilitates reimbursement for RN-FNE services by cooperating with the facility's billing department and interacting with the State reimbursement system.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An RN-FNE shall comply with all State and federal statutes and regulations related to the RN-FNE practice.</text> </paragraph> <paragraph num="E."> <text>An RN-FNE shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards for Training Programs."> <paragraph num="A."> <text>The Board shall approve two RN-FNE standardized curricula as follows:</text> <paragraph num="(1)"> <text>An RN-FNE-Adult curriculum for the examination of adults and individuals 13 years old or older; and</text> </paragraph> <paragraph num="(2)"> <text>An RN-FNE-Pediatric curriculum for the examination of children who are younger than 13 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>New RN-FNE training programs shall:</text> <paragraph num="(1)"> <text>Be approved by the Board before implementation of the FNE training program;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the didactic and clinical experiences are the same as existing FNE programs;</text> </paragraph> <paragraph num="(3)"> <text>Teach the Board-approved curriculum in forensic nurse practice and forensic evidentiary examinations; and</text> </paragraph> <paragraph num="(4)"> <text>Submit the qualifications and curriculum vitae of each faculty member to the Board for review before implementation of the training program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An application for a new FNE program shall be submitted to the Board at least 6 months before the date of the first class.</text> </paragraph> <paragraph num="D."> <text>The successful completion of the RN-FNE-Adult training program shall be a prerequisite to admission to the RN-FNE-Pediatric training program.</text> </paragraph> <paragraph num="E."> <text>The RN-FNE-Adult training program shall include a minimum of 80 clock hours that includes:</text> <paragraph num="(1)"> <text>A minimum of 40 clock hours of theory; and</text> </paragraph> <paragraph num="(2)"> <text>A minimum of 40 clock hours of clinical experience with adults and individuals 13 years old or older.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The RN-FNE-Pediatric training program shall include a minimum of 62 clock hours that includes:</text> <paragraph num="(1)"> <text>A minimum of 30 clock hours of theory; and</text> </paragraph> <paragraph num="(2)"> <text>A minimum of 32 clock hours of pediatric clinical experience.</text> </paragraph> </paragraph> <paragraph num="G."> <text>All clinical requirements for an FNE training program shall be completed within a 12-month period.</text> </paragraph> <paragraph num="H."> <text>Faculty Qualifications.</text> <paragraph num="(1)"> <text>An RN-FNE educator who meets the requirements of this section or a physician whose credentials demonstrate experience in the skills required in forensic evidentiary examinations is qualified to teach both theory and clinical portions of the curriculum and may serve as clinical preceptor for the clinical practicum of the FNE training program.</text> </paragraph> <paragraph num="(2)"> <text>An RN-FNE educator who teaches in an RN-FNE training program or is the clinical preceptor of the training program shall:</text> <paragraph num="(a)"> <text>Be approved by the coordinator of the FNE program: and</text> <paragraph num="(i)"> <text>Have 2 years of experience as an RN-FNE or as a SANE, if from another state;</text> </paragraph> <paragraph num="(ii)"> <text>Have 1 year of FNE experience with ten forensic examinations performed; or</text> </paragraph> <paragraph num="(iii)"> <text>Be deemed by the FNE program coordinator to have the necessary FNE experience and competencies;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Have experience teaching the adult learner;</text> </paragraph> <paragraph num="(c)"> <text>Possess broad knowledge and experience in the multidisciplinary treatment approach to family or sexual interpersonal violence, including intervention techniques; and</text> </paragraph> <paragraph num="(d)"> <text>Have either:</text> <paragraph num="(i)"> <text>Qualified as a forensic nurse examiner expert witness in a criminal proceeding; or</text> </paragraph> <paragraph num="(ii)"> <text>Obtained trial preparation experience with the State's attorney's office.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The clinical preceptor for the clinical practicum of the FNE training program shall document the clinical competency of the RN-FNE candidate at the completion of the clinical practicum.</text> </paragraph> </paragraph> <paragraph num="I."> <text>All changes, additions, or deletions to the FNE training program shall be submitted to the Board for approval not later than 3 months before the date of the first class.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Certification by Endorsement."> <paragraph num="A."> <text>Endorsement Applicant.</text> <paragraph num="(1)"> <text>In addition to the requirement listed in Regulation .03 of this chapter and COMAR 10.27.01.09, an applicant from another state applying for certification to practice as a RN-FNE, RN-FNE-P, or RN-FNE-AP shall:</text> <paragraph num="(a)"> <text>Meet all applicable requirements in §§B—C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Provide evidence of an active practice as a sexual assault nurse examiner which meets the requirements for renewal of certification as stated in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Demonstrate competency of a three orifice evidentiary examination by simulation as verified by a Board approved RN-FNE educator;</text> </paragraph> <paragraph num="(d)"> <text>Complete the endorsement process within 6 months from the date of initial application;</text> </paragraph> <paragraph num="(e)"> <text>Complete in full the application for certification in the area of specialization; and</text> </paragraph> <paragraph num="(f)"> <text>Pay all fees established by the Board in COMAR 10.27.01.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant who does not meet the requirements for renewal under Regulation .07 of this chapter shall complete a Board approved refresher course which is 6.5 hours of didactic education including, but is not limited to:</text> <paragraph num="(a)"> <text>Evidence based best practice for forensic evidentiary examination;</text> </paragraph> <paragraph num="(b)"> <text>Evidence collection;</text> </paragraph> <paragraph num="(c)"> <text>Local jurisdiction requirements; and</text> </paragraph> <paragraph num="(d)"> <text>Maryland criminal law.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant who fails to meet the criteria for endorsement shall meet the requirements in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant from another state applying for certification to practice as a RN-FNE shall submit evidence of prior training and certification by providing the Board with:</text> <paragraph num="(1)"> <text>A current national SANE-A or SANE-P certification, or both, from IAFN; or</text> </paragraph> <paragraph num="(2)"> <text>Proof of successful completion of a SANE-A or RN-FNE-A, adult curriculum which is:</text> <paragraph num="(a)"> <text>Substantially equivalent to the Board’s approved RN-FNE-A curriculum; and</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 80 clock hours that includes:</text> <paragraph num="(i)"> <text>A minimum of 40 clock hours of theory; and</text> </paragraph> <paragraph num="(ii)"> <text>A minimum of 40 clock hours of clinical experience with adults and individuals 13 years of age or older.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant from another state applying for certification to practice as a RN-FNE-P or RN-FNE-AP, shall submit proof of successful completion of the following two curricula:</text> <paragraph num="(1)"> <text>A SANE-A curriculum as referenced in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>A SANE-P or RN-FNE-P, pediatric curriculum that is:</text> <paragraph num="(a)"> <text>Substantially equivalent to the Board-approved RN-FNE-P curriculum; and</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 62 clock hours of instruction that includes:</text> <paragraph num="(i)"> <text>A minimum of 32 clock hours of theory; and</text> </paragraph> <paragraph num="(ii)"> <text>A minimum of 30 clock hours of pediatric clinical experience with individuals who are younger than 13 years of age.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal of Certification."> <paragraph num="A."> <text>Certification to practice as a FNE expires at the same time as the RN license.</text> </paragraph> <paragraph num="B."> <text>Beginning January 1, 2016, renewal requirements will change to reflect the 2-year biennial license renewal that was implemented during 2015.</text> </paragraph> <paragraph num="C."> <text>An FNE who has an even-numbered birth year shall be required:</text> <paragraph num="(1)"> <text>Beginning January 1, 2016, to complete the renewal requirements under §E of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Beginning January 1, 2018, to complete the renewal requirements under §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Beginning January 1, 2017, an FNE who has an odd-numbered birth year shall be required to complete the renewal requirements under §F of this regulation.</text> </paragraph> <paragraph num="E."> <text>Before the certification to practice as an RN-FNE expires, the individual may renew for an additional term, if the RN-FNE:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Has practiced in the role of RN-FNE for a minimum of 400 hours in the previous 24 months in a facility recognized to perform sexual assault forensic evidentiary examinations;</text> </paragraph> <paragraph num="(3)"> <text>Has completed the following evidentiary examinations:</text> <paragraph num="(a)"> <text>If applying for renewal as an RN-FNE-A, three evidentiary examinations on adult patients 13 years of age or older by simulation;</text> </paragraph> <paragraph num="(b)"> <text>If applying for renewal as an RN-FNE-P, three evidentiary examinations on children who are younger than 13 years old; or</text> </paragraph> <paragraph num="(c)"> <text>If applying for renewal as an FNE-AP, three evidentiary examinations on children who are younger than 13 years old, and an additional three evidentiary examinations on adult patients 13 years of age or older by simulation, for a total of six evidentiary examinations performed; or</text> </paragraph> <paragraph num="(d)"> <text>Completed the following requirements:</text> <paragraph num="(i)"> <text>If applying for renewal as an RN-FNE-A, performed ten speculum examinations and observed three evidentiary examinations on adult patients 13 years of age or older;</text> </paragraph> <paragraph num="(ii)"> <text>If applying for renewal as a RN-FNE-P, has observed three evidentiary examinations on children who are younger than 13 years old;</text> </paragraph> <paragraph num="(iii)"> <text>If applying for renewal as an FNE-AP, has observed three evidentiary examinations on children who are younger than 13 years old, has observed an additional three evidentiary examinations on adult patients 13 years of age or older, and performed ten speculum examinations on adult patients 13 years of age or older, for a total of six evidentiary examinations observed and ten speculum examinations performed; and</text> </paragraph> <paragraph num="(iv)"> <text>Have a minimum number of cases submitted to peer review annually in accordance with §G of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provides evidence of having obtained a minimum of 8 education clock hours per year in forensic science or forensic nursing;</text> </paragraph> <paragraph num="(5)"> <text>Pays all appropriate renewal fees set forth by the Board in COMAR 10.27.01.02; and</text> </paragraph> <paragraph num="(6)"> <text>Submits an application for renewal of the certification on the form the Board requires.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Before the certification to practice as an RN-FNE expires, the individual may renew for an additional term, if the RN-FNE:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Has practiced in the role of RN-FNE for a minimum of 400 hours in the previous 24 months in a facility recognized to perform sexual assault forensic evidentiary examinations;</text> </paragraph> <paragraph num="(3)"> <text>Has completed the following evidentiary examinations:</text> <paragraph num="(a)"> <text>If applying for renewal as an RN-FNE-A, six evidentiary examinations on adult patients 13 years old or older by simulation;</text> </paragraph> <paragraph num="(b)"> <text>If applying for renewal as an RN-FNE-P, six evidentiary examinations on children who are younger than 13 years old;</text> </paragraph> <paragraph num="(c)"> <text>If applying for renewal as an FNE-AP, six evidentiary examinations on children who are younger than 13 years old, and an additional six evidentiary examinations on adult patients 13 years old or older by simulation, for a total of twelve evidentiary examinations performed; or</text> </paragraph> <paragraph num="(d)"> <text>Completed the following requirements:</text> <paragraph num="(i)"> <text>If applying for renewal as an RN-FNE-A, performed twenty speculum examinations and observed six evidentiary examinations on adult patients 13 years old or older;</text> </paragraph> <paragraph num="(ii)"> <text>If applying for renewal as an RN-FNE-P, has observed six evidentiary examinations on children who are younger than 13 years old; or</text> </paragraph> <paragraph num="(iii)"> <text>If applying for renewal as an FNE-AP, has observed six evidentiary examinations on children who are younger than 13 years old, has observed an additional six evidentiary examinations on adult patients 13 years old or older, and has performed ten speculum examinations on adult patients 13 years old or older, for a total of twelve evidentiary examinations observed and ten speculum examinations performed; and</text> </paragraph> <paragraph num="(iv)"> <text>Have a minimum number of cases submitted to peer review annually in accordance with §G of this regulation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provides evidence of having obtained a minimum of 16 education clock hours per 24 months in forensic science or forensic nursing;</text> </paragraph> <paragraph num="(5)"> <text>Pays all appropriate renewal fees set forth by the Board in COMAR 10.27.01.02; and</text> </paragraph> <paragraph num="(6)"> <text>Submits an application for renewal of the certification on the form the Board requires.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Peer Review.</text> <paragraph num="(1)"> <text>As a condition of renewal, the following number of cases shall be submitted annually to peer review:</text> <paragraph num="(a)"> <text>Three cases for an RN-FNE-A;</text> </paragraph> <paragraph num="(b)"> <text>Three cases for an RN-FNE-P; and</text> </paragraph> <paragraph num="(c)"> <text>Three adult cases and three pediatric cases for a total of six cases for an RN-FNE-AP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An examination done by simulation may be included in the cases for peer review.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the individual does not meet the requirement of §§E(2) and F(2) of this regulation, the individual shall complete a Board-approved course before becoming eligible for renewal of the certification.</text> </paragraph> <paragraph num="I."> <text>With respect to the requirement set forth in §§E(3) and F(3) of this regulation, an examination performed on a live model or by simulation may substitute for evidentiary examinations for the purpose of certificate renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reinstatement of Certification."> <paragraph num="A."> <text>If the applicant does not meet the requirements in Regulation .07 of this chapter, the applicant may apply for re-instatement if the applicant:</text> <paragraph num="(1)"> <text>Either:</text> <paragraph num="(a)"> <text>Has a current, active RN license; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has not practiced as a RN-FNE for more than 36 months;</text> </paragraph> <paragraph num="(3)"> <text>Has successfully completed a Board-approved refresher course that is 6.5 hours of didactic instruction for the RN-FNE which includes, but is not limited to:</text> <paragraph num="(a)"> <text>Evidence based best practice for forensic evidentiary examination;</text> </paragraph> <paragraph num="(b)"> <text>Evidence collection;</text> </paragraph> <paragraph num="(c)"> <text>Local jurisdiction requirements; and</text> </paragraph> <paragraph num="(d)"> <text>Maryland criminal law; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has demonstrated clinical competency of a three orifice evidentiary examination for:</text> <paragraph num="(a)"> <text>An adult patient 13 years of age or older or by simulation for certification as an RN-FNE-A;</text> </paragraph> <paragraph num="(b)"> <text>Children younger than 13 years of age for certification as an RN-FNE-P; or</text> </paragraph> <paragraph num="(c)"> <text>An adult patient 13 years of age or older by simulation and by patient examination on children younger than 13 years of age or older for certification as an RN-FNE-AP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for reinstatement of certification has 6 months from the date of initial application to complete the reinstatement process.</text> </paragraph> <paragraph num="C."> <text>An applicant who fails to meet the criteria for reinstatement of the certification shall meet the requirements in Regulation .03 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Unlawful Practice."> <paragraph num="A."> <text>Unless authorized to practice under this chapter, an individual may not use the words “forensic nurse examiner” or the acronyms “RN-FNE”, “RN-FNE-A”, “RN-FNE-P”, or “RN-FNE-AP”, or any other words, letters, or symbols with the intent to represent the individual as any category of RN-FNE.</text> </paragraph> <paragraph num="B."> <text>An individual may not use any form of the designation RN-FNE unless authorized by the Board.</text> </paragraph> <paragraph num="C."> <text>An individual may not offer to perform or perform the activities of a RN-FNE enumerated in Regulation .04A of this chapter unless certified under this chapter or otherwise permitted by law to engage in these activities.</text> </paragraph> <paragraph num="D."> <text>A registered or licensed practical nurse may not perform any task or function listed under Regulation .04A of this chapter unless certified under this chapter.</text> </paragraph> <paragraph num="E."> <text>An individual authorized under this chapter to practice as an RN-FNE is subject to the disciplinary prohibitions and sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §§8-205 and 8-312; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 13, 1999 (26:25 Md. R. 1898)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed and new Regulations .01—.08 adopted effective April 28, 2003 (30:8 Md. R. 542)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 25, 2006 (33:19 Md. R. 1561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D adopted effective September 25, 2006 (33:19 Md. R. 1561)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 19, 2012 (39:5 Md. R. 383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254); September 10, 2018 (45:18 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 10, 2018 (45:18 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E adopted effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 18, 2016 (43:1 Md. R. 13); February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective September 10, 2018 (45:18 Md. R. 834)</annotation> </annotations> </chapter> <chapter num="22" heading="Multistate Licensure Compact Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the regulatory body responsible for issuing nurse licenses.</text> </paragraph> <paragraph num="(2)"> <text>“Information System” means the coordinated licensure information system.</text> </paragraph> <paragraph num="(3)"> <text>“Primary state of residence” means the state of an individual's declared, fixed, permanent, and principal home for legal purposes: domicile.</text> </paragraph> <paragraph num="(4)"> <text>“Public” means any individual or entity other than designated staff or representatives of party state boards or the National Council of State Boards of Nursing, Inc.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Issuance of a License by a Compact Party State."> <paragraph num="A."> <text>As of July 1, 2005, no applicant for initial licensure will be issued a compact license granting a multistate privilege to practice unless the applicant first obtains a passing score on the applicable NCLEX examination or any predecessor examination used for licensure.</text> </paragraph> <paragraph num="B."> <text>Home Party State License.</text> <paragraph num="(1)"> <text>A nurse applying for a license in a home party state shall produce evidence of the nurse’s primary state of residence.</text> </paragraph> <paragraph num="(2)"> <text>The evidence required in §B(1) of this regulation shall include a declaration signed by the licensee.</text> </paragraph> <paragraph num="(3)"> <text>Further evidence that may be requested may include but is not limited to a:</text> <paragraph num="(a)"> <text>Driver's license with a home address;</text> </paragraph> <paragraph num="(b)"> <text>Voter registration card displaying a home address;</text> </paragraph> <paragraph num="(c)"> <text>Federal income tax return declaring the primary state of residence;</text> </paragraph> <paragraph num="(d)"> <text>Military Form No. 2058, State of Legal Residence Certificate; or</text> </paragraph> <paragraph num="(e)"> <text>W2 form from the United States government or any bureau, division, or agency thereof indicating the declared state of residence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A nurse on a visa from another country applying for licensure in a party state may declare either the country of origin or the party state as the primary state of residence. If the foreign country is declared the primary state of residence, a single state license shall be issued by the party state.</text> </paragraph> <paragraph num="D."> <text>A license issued by a party state is valid for practice in all other party states unless clearly designated as valid only in the state which issued the license.</text> </paragraph> <paragraph num="E."> <text>Single State License.</text> <paragraph num="(1)"> <text>When a party state issues a license authorizing practice only in that state and not authorizing practice in other party states, the license shall be clearly marked with words indicating that it is valid only in the state of issuance.</text> </paragraph> <paragraph num="(2)"> <text>A license that is only valid for the party state is called a single state license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A nurse changing primary state of residence, from one party state to another party state, may continue to practice under the former home state license and multistate licensure privilege during the processing of the nurse’s licensure application in the new home state for a period not to exceed 90 days.</text> </paragraph> <paragraph num="G."> <text>The licensure application in the new home state of a nurse under pending investigation by the former home state shall be held in abeyance, and the 90-day period in §F of this regulation shall be stayed until resolution of the pending investigation.</text> </paragraph> <paragraph num="H."> <text>The former home state license is not valid upon the issuance of a new home state license.</text> </paragraph> <paragraph num="I."> <text>If a decision is made by the new home state denying licensure, the new home state shall notify the former home state within 10 business days, and the former home state may take action in accordance with that state's laws and regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Limitations on Multistate Licensure Privilege — Discipline."> <paragraph num="A."> <text>Home state boards shall include, in all disciplinary orders or agreements that limit practice or require monitoring, the requirement that the licensee subject to the order or agreement shall limit the licensee's practice to the home state during the pendency of the disciplinary order or agreement.</text> </paragraph> <paragraph num="B."> <text>The requirement referred to in §A of this regulation may, in the alternative, allow the nurse to practice in other party states with prior written authorization from both the home state and other party state boards.</text> </paragraph> <paragraph num="C."> <text>An individual who had a license which was surrendered, revoked, or suspended, or an application denied for cause in a prior state of primary residence, may be issued a single state license in a new primary state of residence until such time as the individual would be eligible for an unrestricted license by the prior state or states where there was an adverse action.</text> </paragraph> <paragraph num="D."> <text>Once eligible for licensure in the prior state or states, a multistate license may be issued.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Information System."> <paragraph num="A."> <text>Levels of Access.</text> <paragraph num="(1)"> <text>Public access to nurse licensure information shall be limited to:</text> <paragraph num="(a)"> <text>The licensee's name;</text> </paragraph> <paragraph num="(b)"> <text>Jurisdictions of licensure;</text> </paragraph> <paragraph num="(c)"> <text>Licensure expiration date;</text> </paragraph> <paragraph num="(d)"> <text>Licensure classification and status;</text> </paragraph> <paragraph num="(e)"> <text>Public emergency, summary, and final disciplinary actions, as defined by contributing state authority; and</text> </paragraph> <paragraph num="(f)"> <text>The status of multistate licensure privileges.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Non-party state boards shall have access to all Information System data except current significant investigative information and other information as limited by contributing party state authority.</text> </paragraph> <paragraph num="(3)"> <text>Party state boards shall have access to all Information System data contributed by the party states and other information as allowed by contributing non-party state authority.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Right to Review.</text> <paragraph num="(1)"> <text>The licensee may request, in writing, to the home state board to review data relating to the licensee in the Information System.</text> </paragraph> <paragraph num="(2)"> <text>If a licensee asserts that any data relating to the licensee is inaccurate, the burden of proof is on the licensee to provide evidence substantiating that claim.</text> </paragraph> <paragraph num="(3)"> <text>Within 10 business days, the Board shall correct information that it finds to be inaccurate in the Information System.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Changes in Disciplinary Data.</text> <paragraph num="(1)"> <text>Within 10 business days, the Board shall report to the Information System:</text> <paragraph num="(a)"> <text>Disciplinary action, agreement, or order requiring participation in alternative programs or which limit practice or require monitoring unless the agreement or order relating to participation in alternative programs is required to remain nonpublic by the contributing state authority;</text> </paragraph> <paragraph num="(b)"> <text>Dismissal of the complaint; and</text> </paragraph> <paragraph num="(c)"> <text>Changes in status of disciplinary action, or licensure encumbrance.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall delete current significant investigative information from the Information System within 10 business days after:</text> <paragraph num="(a)"> <text>A disciplinary action;</text> </paragraph> <paragraph num="(b)"> <text>An agreement or order requiring participation in alternative programs;</text> </paragraph> <paragraph num="(c)"> <text>An agreement or agreements which limit practice or require monitoring; or</text> </paragraph> <paragraph num="(d)"> <text>Dismissal of a complaint.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Information System administrator shall make changes to licensure information in the Information System within 10 business days upon notification by a board.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1) and 8-7A-01—8-7A-05, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 140); adopted permanently effective April 17, 2000 (27:7 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective January 18, 2016 (43:1 Md. R. 13)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> </annotations> </chapter> <chapter num="23" heading="Code of Conduct for Board Members and Investigators"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes a code of conduct for:</text> <paragraph num="A."> <text>Members of Board of Nursing; and</text> </paragraph> <paragraph num="B."> <text>Investigators employed by the Board of Nursing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicted.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Board member” means an individual appointed by the Governor to serve on the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Charging document” means the notice from the Board pursuant to State Government Article, §10-208, Annotated Code of Maryland, which informs a licensee of an alleged violation or violations of a Board's statute by the licensee.</text> </paragraph> <paragraph num="(4)"> <text>“Complaint” means a communication to a Board of a possible violation of the disciplinary provisions outlined in Health Occupations Code, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Conflict of interest” means a situation in which a personal interest of a Board member or a Board investigator presents a potential conflict with the public interest in connection with an anticipated public action or decision.</text> </paragraph> <paragraph num="(6)"> <text>“Ex parte communication” means a direct or indirect communication between a Board member and another party regarding the merits of an issue in a pending contested disciplinary case, if the communication is made outside the presence of the opposing party.</text> </paragraph> <paragraph num="(7)"> <text>“Investigator” means an individual who investigates complaints received by the Board.</text> </paragraph> <paragraph num="(8)"> <text>“Recusal” means nonparticipation of a Board member in a specific matter before the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Recusal of Board Members."> <paragraph num="A."> <text>Standard for Recusal.</text> <paragraph num="(1)"> <text>A Board member shall recuse himself or herself from Board proceedings which involve situations in which the Board member:</text> <paragraph num="(a)"> <text>Has a conflict of interest; or</text> </paragraph> <paragraph num="(b)"> <text>Cannot participate fairly and impartially.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Personal familiarity with a respondent does not, of itself, require recusal of a Board member.</text> </paragraph> <paragraph num="(3)"> <text>A Board member may seek advice of the Board's counsel in determining the need for recusal on a specific matter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Recusal.</text> <paragraph num="(1)"> <text>The Board member who is recused from a matter before the Board, may not:</text> <paragraph num="(a)"> <text>Participate in the Board's discussion or vote on the matter; or</text> </paragraph> <paragraph num="(b)"> <text>Discuss the matter or the Board's review of the matter with members of the Board or other individuals.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the matter before the Board is a disciplinary matter, the Board member who is recused shall physically leave the room to ensure nonparticipation.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall document the recusal of the Board member in the minutes of the Board meeting.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Recusal for Complaint Against a Board Member.</text> <paragraph num="(1)"> <text>A Board member against whom a complaint is filed shall follow §B of this regulation for all discussion and voting concerning the complaint filed against the Board member.</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that there is an additional matter before the Board which is reasonably related to the complaint filed against the Board member, the Board member against whom the complaint is filed shall follow §B of this regulation for the additional matter also.</text> </paragraph> <paragraph num="(3)"> <text>If, after investigation of the complaint, the Board refers the case to the Attorney General's Office, the Board member shall recuse himself or herself from all Board activities until the final disposition of the case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Investigator."> <paragraph num="A."> <text>An investigator may not conduct or participate in an investigation of a complaint in which the investigator has a conflict of interest.</text> </paragraph> <paragraph num="B."> <text>In the investigation of a complaint against a member of a Board, the Board may consider using an investigator other than the investigator who is regularly assigned to conduct investigations for the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Confidentiality."> <paragraph num="A."> <text>A Board member or investigator may not discuss disciplinary or other confidential matters with a person other than:</text> <paragraph num="(1)"> <text>A Board member;</text> </paragraph> <paragraph num="(2)"> <text>Board staff;</text> </paragraph> <paragraph num="(3)"> <text>The Attorney General's Office;</text> </paragraph> <paragraph num="(4)"> <text>A witness; or</text> </paragraph> <paragraph num="(5)"> <text>Another person authorized by law to be involved in the case.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the case of an ex parte communication, the Board member shall follow the provisions of the State Government Article, §10-219, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §8-205(a)(1), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 25, 2000 (27:25 Md. R. 2282)</annotation> </annotations> </chapter> <chapter num="24" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>A custodian of Board records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, whether or not there has been a request for the information under the following circumstances:</text> <paragraph num="A."> <text>There is possible criminal activity and the disclosure is to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>There is possible violation of law and the disclosure is to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation or over a facility in which the individual has practiced and the information disclosed is limited to that information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>There is conduct by an individual that the Board reasonably believes may pose a risk to the public health, safety, or welfare and the disclosure is to a law enforcement authority, administrative official, or agency that regulates the individual or regulates a facility in which the individual has practiced, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §10-617(h)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 23, 2001 (28:14 Md. R. 1322)</annotation> </annotations> </chapter> <chapter num="25" heading="Cosmetic Procedures"> <regulation prefix="Regulation" num=".01" heading="Exclusion from Regulations."> <paragraph num="A."> <text>This chapter is not applicable to, and does not restrict or limit, other health care practitioners who are authorized to perform these duties under their respective practice acts.</text> </paragraph> <paragraph num="B."> <text>This chapter does not restrict or limit a Maryland Certified Registered Nurse Practitioner from possessing, prescribing, evaluating, or performing the procedures under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Body treatment” means cellulite lymphatic drainage and cellulite vacuum massage.</text> </paragraph> <paragraph num="(2)"> <text>“Cellulite lymphatic drainage” means a therapy in which the practitioner uses a range of specialized and gentle rhythmic pumping techniques to move the skin in the direction of the lymph flow.</text> </paragraph> <paragraph num="(3)"> <text>“Cellulite vacuum massage” means:</text> <paragraph num="(a)"> <text>The massage of peripheral blood, lymph, and inter-tissue liquid with the goal of reducing stagnation of these fluids and increasing the skin’s elasticity; and</text> </paragraph> <paragraph num="(b)"> <text>The external use of a vacuum component directly on the area to be massaged followed by a straight line, circular, or zigzag movement to massage the area.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Chemical peels” also called deep skin peels, means the removal of the top layers of skin using chemicals applied directly to the skin.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical preceptor” means a licensed or certified individual who is:</text> <paragraph num="(a)"> <text>Proficient in the procedure for which they are precepting; and</text> </paragraph> <paragraph num="(b)"> <text>Permitted by the appropriate health occupation licensing board to provide care and treatment for cosmetic services.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Cryotherapy” means the application of:</text> <paragraph num="(a)"> <text>Extreme cold to destroy abnormal or diseased tissue, warts, moles, skin tags, and solar keratoses; and</text> </paragraph> <paragraph num="(b)"> <text>Liquid nitrogen to freeze tissues at the cellular level.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Dermal fillers” means various types of natural or man-made materials which are injected intradermally to correct imperfections in the skin and subcutaneous tissue.</text> </paragraph> <paragraph num="(8)"> <text>“Direct supervision” means on site, physically present, accessible in the immediate patient care area and available to intervene if necessary.</text> </paragraph> <paragraph num="(9)"> <text>“Injectable treatments” means the use of FDA approved medication and includes the following:</text> <paragraph num="(a)"> <text>Dermal fillers;</text> </paragraph> <paragraph num="(b)"> <text>Micropigmentation, also known as cosmetic tattoo or permanent make-up; and</text> </paragraph> <paragraph num="(c)"> <text>Neuromuscular agents.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Laser treatment” means a technique in which exposure to low-level laser light or light emitting diodes are used to stimulate or inhibit cellular function possibly leading to beneficial clinical effects.</text> </paragraph> <paragraph num="(11)"> <text>Light Treatment.</text> <paragraph num="(a)"> <text>“Light treatment” also known as phototherapy, means the use of non-ionizing electro-magnetic radiation for therapeutic benefit.</text> </paragraph> <paragraph num="(b)"> <text>“Light treatment” does not mean laser treatment.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Lipodissolve” means a procedure that uses subcutaneous micro-injections of drugs with the sole purpose of dissolving fat for body contouring.</text> </paragraph> <paragraph num="(13)"> <text>Magenta Light.</text> <paragraph num="(a)"> <text>“Magenta light” means a non-invasive technique that combines infrared and magenta light with subdermal tissue massage to produce a penetrating light that affects the epidermis, alters cellulite formation, and controls cellulite formation at the cellular level.</text> </paragraph> <paragraph num="(b)"> <text>“Magenta light” does not mean laser or intensive pulse light.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Mesotherapy” also known as intradermotherapy, means a non-invasive cosmetic treatment which employs multiple intra or subcutaneous injections of pharmaceutical and homeopathic medications, plant extracts, vitamins, and other ingredients for the treatment of fat or cellulite.</text> </paragraph> <paragraph num="(15)"> <text>“Micro current treatment” means passing radio frequency electricity through the skin to:</text> <paragraph num="(a)"> <text>Heat up tissue;</text> </paragraph> <paragraph num="(b)"> <text>Cause the tissue to contract; and</text> </paragraph> <paragraph num="(c)"> <text>Stimulate collagen production.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Neuromuscular agents” means injectable drugs that cause muscle weakness for the purpose of cosmetic softening of wrinkles and includes, but is not limited to, Botox and Dysport.</text> </paragraph> <paragraph num="(17)"> <text>“Nurse” means a registered nurse (RN) or a licensed practical nurse (LPN).</text> </paragraph> <paragraph num="(18)"> <text>“Peels” or “Topicals” means:</text> <paragraph num="(a)"> <text>Chemicals peels;</text> </paragraph> <paragraph num="(b)"> <text>Cryotherapy; or</text> </paragraph> <paragraph num="(c)"> <text>Microdermabrasion.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Photochemotherapy” means the use of a photodynamic light source to destroy dystrophic cells.</text> </paragraph> <paragraph num="(20)"> <text>“Photodynamic (PDT)” means the use of a light source, combined with a light-sensitive drug to destroy dystrophic cells.</text> </paragraph> <paragraph num="(21)"> <text>“Photosensitizing agent” means a drug used with a photodynamic light source to produce a therapeutic photosensitivity.</text> </paragraph> <paragraph num="(22)"> <text>“Precepted clinical practice” means after theoretical learning and until competency is achieved:</text> <paragraph num="(a)"> <text>Working directly with patients;</text> </paragraph> <paragraph num="(b)"> <text>Performing cosmetic or dermatologic procedures on patients; and</text> </paragraph> <paragraph num="(c)"> <text>Working under the direct supervision of a clinical preceptor who has the knowledge and ability to perform the procedure independently.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>Radio Frequency and Current.</text> <paragraph num="(a)"> <text>“Radio frequency and current” means:</text> <paragraph num="(i)"> <text>Magenta light;</text> </paragraph> <paragraph num="(ii)"> <text>Microcurrent treatment;</text> </paragraph> <paragraph num="(iii)"> <text>Photochemotherapy;</text> </paragraph> <paragraph num="(iv)"> <text>Photodynamic;</text> </paragraph> <paragraph num="(v)"> <text>Thermage; and</text> </paragraph> <paragraph num="(vi)"> <text>Ultrasound (therapeutic only).</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Radio frequency and current” does not mean laser.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>Theory.</text> <paragraph num="(a)"> <text>“Theory” means the body of knowledge regarding the principles underlying the safe execution of a cosmetic procedure and is obtained through didactic instruction provided by a licensed health care provider who has the knowledge and skill to perform the procedure.</text> </paragraph> <paragraph num="(b)"> <text>“Theory” includes didactic instruction by the licensed health care provider which may be augmented by a manufacturer’s representative.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Thermage” means the use of radio frequency technology to:</text> <paragraph num="(a)"> <text>Target collagen in the dermis layer of the skin around the eyes and forehead; and</text> </paragraph> <paragraph num="(b)"> <text>Cause the dermis and underlying tissue to tighten.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>Ultrasound.</text> <paragraph num="(a)"> <text>“Ultrasound” means the therapeutic use of inaudible sound in the frequency range of approximately 20,000 to 10,000,000,000 cycles per second for therapeutic use at low intensity producing a heating effect to stimulate collagen production.</text> </paragraph> <paragraph num="(b)"> <text>“Ultrasound” does not mean the use of ultrasound for diagnostic purposes.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Procedural Categories."> <paragraph num="A."> <text>Procedures designated as Category A shall include body treatments with:</text> <paragraph num="(1)"> <text>Cellulite lymphatic drainage; and</text> </paragraph> <paragraph num="(2)"> <text>Cellulite vacuum massage.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Procedures designated as Category B shall include light treatments with:</text> <paragraph num="(1)"> <text>Infrared light;</text> </paragraph> <paragraph num="(2)"> <text>Magenta light;</text> </paragraph> <paragraph num="(3)"> <text>Photochemotherapy;</text> </paragraph> <paragraph num="(4)"> <text>Photodynamic;</text> </paragraph> <paragraph num="(5)"> <text>Photosensitizing agents;</text> </paragraph> <paragraph num="(6)"> <text>UVA light; and</text> </paragraph> <paragraph num="(7)"> <text>UVB light.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures designated as Category C shall include laser treatments administered by a selective laser.</text> </paragraph> <paragraph num="D."> <text>Procedures designated as Category D shall include injectable treatments with:</text> <paragraph num="(1)"> <text>Dermal fillers;</text> </paragraph> <paragraph num="(2)"> <text>Micropigmentation with topical anesthetics only; and</text> </paragraph> <paragraph num="(3)"> <text>Neuromuscular agents.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Procedures designated as Category E shall include radio frequency and current treatments with:</text> <paragraph num="(1)"> <text>Micro current;</text> </paragraph> <paragraph num="(2)"> <text>Thermage; and</text> </paragraph> <paragraph num="(3)"> <text>Ultrasound.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures designated as Category F shall include peels or topicals with:</text> <paragraph num="(1)"> <text>Chemical peels;</text> </paragraph> <paragraph num="(2)"> <text>Cryotherapy;</text> </paragraph> <paragraph num="(3)"> <text>Microdermabrasion; and</text> </paragraph> <paragraph num="(4)"> <text>Power peel.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Education."> <text>To administer medication or to perform cosmetic and dermatologic treatments, a nurse shall:</text> <paragraph num="A."> <text>Complete a program of study that includes theory appropriate to the medication to be administered and the procedure to be performed that includes, but is not limited to:</text> <paragraph num="(1)"> <text>Anatomy, physiology, and pathophysiology related to the integumentary system as well as systems specific to the procedure being performed;</text> </paragraph> <paragraph num="(2)"> <text>Appropriate technique for each cosmetic procedure;</text> </paragraph> <paragraph num="(3)"> <text>Nursing assessment, cosmetic indications, and contraindications for treatment;</text> </paragraph> <paragraph num="(4)"> <text>Pharmacology intervention specific to the cosmetic procedure including, but not limited to:</text> <paragraph num="(a)"> <text>Assessment and monitoring of the receiving the medication;</text> </paragraph> <paragraph num="(b)"> <text>Effects and potential side effects of the medication;</text> </paragraph> <paragraph num="(c)"> <text>Contraindications to the administration of the medication;</text> </paragraph> <paragraph num="(d)"> <text>The ability to anticipate and recognize potential complications of the medication;</text> </paragraph> <paragraph num="(e)"> <text>The ability to recognize emergency situations and institute appropriate interventions;</text> </paragraph> <paragraph num="(f)"> <text>Preparation, storing, and handling of the medication; and</text> </paragraph> <paragraph num="(g)"> <text>Proficiency in administering the medication by the required route;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Selection, maintenance, and utilization of equipment;</text> </paragraph> <paragraph num="(6)"> <text>Identification of realistic and expected outcomes of the procedure;</text> </paragraph> <paragraph num="(7)"> <text>Identification of complications or adverse reactions;</text> </paragraph> <paragraph num="(8)"> <text>Nursing care required and appropriate nursing interventions in the event of complications or untoward outcomes;</text> </paragraph> <paragraph num="(9)"> <text>Infection control procedures;</text> </paragraph> <paragraph num="(10)"> <text>Safety precautions appropriate to each procedure;</text> </paragraph> <paragraph num="(11)"> <text>Documentation appropriate to the type of the procedure being performed; and</text> </paragraph> <paragraph num="(12)"> <text>Precepted clinical practice by a clinical preceptor that includes documented initial and annual competency of the nurse in each cosmetic procedure the nurse is to perform;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Document evidence of clinical and psychomotor proficiency competency before independently performing each cosmetic procedure;</text> </paragraph> <paragraph num="C."> <text>Perform the procedures on a frequent routine predictable basis in order to retain practice proficiency;</text> </paragraph> <paragraph num="D."> <text>Be evaluated for continued clinical competency at periodic intervals; and</text> </paragraph> <paragraph num="E."> <text>Obtain additional education when the population changes or new procedures are introduced into the practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Cosmetic Procedures in General."> <paragraph num="A."> <text>The nurse shall comply with the employment settings written cosmetic policies and procedures that comply with this chapter.</text> </paragraph> <paragraph num="B."> <text>The nurse shall be guided by and comply with the written policies and procedures in keeping with recognized standards of care that include, but are not limited to:</text> <paragraph num="(1)"> <text>Care and maintenance of appropriate equipment and safe operation;</text> </paragraph> <paragraph num="(2)"> <text>Description of how the procedure is to be performed;</text> </paragraph> <paragraph num="(3)"> <text>Education;</text> </paragraph> <paragraph num="(4)"> <text>Assessment;</text> </paragraph> <paragraph num="(5)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(6)"> <text>Monitoring guidelines;</text> </paragraph> <paragraph num="(7)"> <text>Operator and safety when utilizing equipment;</text> </paragraph> <paragraph num="(8)"> <text>A continuous quality improvement process which includes, but is not limited to:</text> <paragraph num="(a)"> <text>Unexpected outcomes;</text> </paragraph> <paragraph num="(b)"> <text>Side effects; and</text> </paragraph> <paragraph num="(c)"> <text>Complications;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Obtaining or ensuring that the client’s informed consent has been obtained that documents the patient’s awareness that it is the licensed nurse who will perform the cosmetic procedure; and</text> </paragraph> <paragraph num="(10)"> <text>Documenting the performance of the cosmetic procedure including, but not limited to:</text> <paragraph num="(a)"> <text>Patient response;</text> </paragraph> <paragraph num="(b)"> <text>Patient education; and</text> </paragraph> <paragraph num="(c)"> <text>Safety precautions taken on behalf of the patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The nurse may perform the identified cosmetic procedure when there is a completed prescriptive order from an authorized prescriber that includes, but is not limited to:</text> <paragraph num="(1)"> <text>The procedure to be performed;</text> </paragraph> <paragraph num="(2)"> <text>Identification of the specific treatment area;</text> </paragraph> <paragraph num="(3)"> <text>Identification of medication, dosage, route, and time interval for administration of the medication for the specific cosmetic procedure;</text> </paragraph> <paragraph num="(4)"> <text>Identification of the light source and the radio frequency, current dosage, intensity, and time period it is to be applied; and</text> </paragraph> <paragraph num="(5)"> <text>The use of any topical anesthetic.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before a nurse performs any of these cosmetic procedures, the authorized prescriber shall:</text> <paragraph num="(1)"> <text>Complete an initial assessment and evaluation of the patient before the procedure is performed;</text> </paragraph> <paragraph num="(2)"> <text>Develop a treatment plan for the specific patient;</text> </paragraph> <paragraph num="(3)"> <text>Be physically present in the setting; and</text> </paragraph> <paragraph num="(4)"> <text>Be immediately available:</text> <paragraph num="(a)"> <text>At the time the procedure is performed; and</text> </paragraph> <paragraph num="(b)"> <text>Post-treatment to evaluate the patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The nurse shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Cosmetic Procedures — Licensed Practical Nurse."> <text>Except for Category C, the LPN may perform the cosmetic procedures identified in Regulation .03 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Cosmetic Procedures — RN."> <text>The RN may perform all of the procedures identified in Regulation .03 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Exceptions."> <text>Except for cryotherapy, the nurse may perform the cosmetic procedures identified in Regulation .03 Category F independent of the requirements stated in Regulation .05D of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Prohibited Acts."> <paragraph num="A."> <text>The licensed nurse may not:</text> <paragraph num="(1)"> <text>Perform cosmetic procedures on a standing order or protocol;</text> </paragraph> <paragraph num="(2)"> <text>Perform the pre-procedure medical assessment or evaluation;</text> </paragraph> <paragraph num="(3)"> <text>Perform medical diagnosis or prescribe cosmetic procedures;</text> </paragraph> <paragraph num="(4)"> <text>Develop the client treatment plan;</text> </paragraph> <paragraph num="(5)"> <text>Prescribe medications for cosmetic or dermatological procedures;</text> </paragraph> <paragraph num="(6)"> <text>Perform the post-procedure medical evaluation of the client; and</text> </paragraph> <paragraph num="(7)"> <text>Administer injections for the purpose of:</text> <paragraph num="(a)"> <text>Mesotherapy; and</text> </paragraph> <paragraph num="(b)"> <text>Lipodissolve.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The nurse may not perform:</text> <paragraph num="(1)"> <text>Liposuction;</text> </paragraph> <paragraph num="(2)"> <text>Hair transplants;</text> </paragraph> <paragraph num="(3)"> <text>Invasive radiofrequency procedures;</text> </paragraph> <paragraph num="(4)"> <text>Phenopeels;</text> </paragraph> <paragraph num="(5)"> <text>Sculptra injections; and</text> </paragraph> <paragraph num="(6)"> <text>Lipostabil or phosphatidycholine for the purpose of lipodissolve.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §4-403; Health Occupations Article, §8-205(a)(1) and (2); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 30, 2011 (38:11 Md. R. 671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="26" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees and certificate holders in formal and informal disciplinary proceedings.</text> </paragraph> <paragraph num="B."> <text>The Board shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation.</text> </paragraph> <paragraph num="C."> <text>There may be conduct by a licensee or certificate holder that does not fall squarely within a particular category of misconduct contained in Regulation .07 of this chapter. In that event, the Board will use its discretion to determine the appropriate category and sanction.</text> </paragraph> <paragraph num="D."> <text>The Board shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees and certificate holders.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Certificate holder” means an individual who has been issued a certificate by the Board to practice as a certified nursing assistant, a certified dialysis technician, or a certified medication technician.</text> </paragraph> <paragraph num="(3)"> <text>“Conditions” means any requirements in a public or nonpublic order that a licensee or certificate holder is required to satisfy, which include, but are not limited to:</text> <paragraph num="(a)"> <text>Treatment and counseling for a psychological or physical illness, including, but not limited to substance abuse;</text> </paragraph> <paragraph num="(b)"> <text>Submission to drug and alcohol testing;</text> </paragraph> <paragraph num="(c)"> <text>Abstinence from specified drugs;</text> </paragraph> <paragraph num="(d)"> <text>Abstinence from alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Remedial training;</text> </paragraph> <paragraph num="(f)"> <text>Inspection of a private practice site;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring;</text> </paragraph> <paragraph num="(h)"> <text>Evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(j)"> <text>Compliance with a rehabilitation agreement;</text> </paragraph> <paragraph num="(k)"> <text>Testing of clinical skills;</text> </paragraph> <paragraph num="(l)"> <text>Submission of written reports;</text> </paragraph> <paragraph num="(m)"> <text>A demonstration of knowledge or competency;</text> </paragraph> <paragraph num="(n)"> <text>Submit to a physical or mental health examination;</text> </paragraph> <paragraph num="(o)"> <text>Limitation of practice; and</text> </paragraph> <paragraph num="(p)"> <text>Limitation on the administration of prescription or specified drugs to clients.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Conduct” means behavior or action or a failure to behave or act, which results in a violation of the Maryland Nurse Practice Act or regulations adopted by the Board.</text> </paragraph> <paragraph num="(5)"> <text>“Licensee” means an individual who:</text> <paragraph num="(a)"> <text>Has been issued a license or certification by the Board to practice as:</text> <paragraph num="(i)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed practical nurse;</text> </paragraph> <paragraph num="(iii)"> <text>An advanced practice registered nurse;</text> </paragraph> <paragraph num="(iv)"> <text>An electrologist;</text> </paragraph> <paragraph num="(v)"> <text>A licensed direct-entry midwife; or</text> </paragraph> <paragraph num="(vi)"> <text>A licensed certified midwife; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing or registered nursing under the Nurse Licensure Compact.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(7)"> <text>“Recklessly” means characterized by the creation of a substantial and unjustifiable risk of harm to others and by a conscious, sometimes deliberate, disregard for or indifference to that risk.</text> </paragraph> <paragraph num="(8)"> <text>“Sanction” means a disciplinary action against a licensee or certificate holder, including a reprimand, probation, suspension, revocation, or a monetary penalty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>This chapter is not applicable to cases in which the Board, after investigating a matter, decides to issue a public advisory letter in lieu of discipline in accordance with Health Occupations Article, §8-317(h) or 8-6B-19(h), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>This chapter is not applicable to:</text> <paragraph num="(1)"> <text>An individual seeking an initial license or certificate; or</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a licensee or certificate holder under State Government Article, §10-226, Annotated Code of Maryland, or Health Occupations Article, §8-317(g), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter is not applicable to violations for which a mandatory sanction or penalty is set by statute or regulation.</text> </paragraph> <paragraph num="D."> <text>The severity of sanctions is ranked as follows, from least severe to most severe:</text> <paragraph num="(1)"> <text>Reprimand;</text> </paragraph> <paragraph num="(2)"> <text>Probation;</text> </paragraph> <paragraph num="(3)"> <text>Suspension; and</text> </paragraph> <paragraph num="(4)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The addition of a monetary penalty to a sanction does not change the ranking of the severity of the sanction.</text> </paragraph> <paragraph num="F."> <text>If a monetary penalty is added to a sanction, a sanction with a higher monetary penalty is more severe than the same sanction with a lesser monetary penalty.</text> </paragraph> <paragraph num="G."> <text>When a licensee or certificate holder’s conduct results in multiple violations of the Maryland Nurse Practice Act or regulations adopted by the Board, the Board:</text> <paragraph num="(1)"> <text>May consider sanctions that are greater than those imposed for a single violation; and</text> </paragraph> <paragraph num="(2)"> <text>Has discretion to apply the category with the highest maximum sanction.</text> </paragraph> </paragraph> <paragraph num="H."> <text>In the event that a licensee’s or certificate holder’s violation of the Maryland Nurse Practice Act or regulations adopted by the Board does not fall within a particular category of misconduct included in Regulation .07 of this chapter, the Board shall:</text> <paragraph num="(1)"> <text>Use its discretion to determine the appropriate sanction; and</text> </paragraph> <paragraph num="(2)"> <text>Consider, to the extent possible, the sanctioning guidelines set forth in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="I."> <text>In the event that the Board determines that a licensee’s or certificate holder’s violation of the Maryland Nurse Practice Act or regulations adopted by the Board falls within more than one category of misconduct established under Regulation .07 of this chapter, the Board shall, in its discretion, determine the category under which the violation shall be adjudicated.</text> </paragraph> <paragraph num="J."> <text>The period of a suspension may be stayed in whole or in part.</text> </paragraph> <paragraph num="K."> <text>Any sanction imposed by the Board in accordance with the sanctioning guidelines set forth in Regulation .07 of this chapter may be accompanied by conditions reasonably related to the violation or to the rehabilitation of the licensee or certificate holder.</text> </paragraph> <paragraph num="L."> <text>The inclusion of conditions with any sanction is within the discretion of the Board and does not factor into a determination of whether a particular sanction falls within or outside of the sanctioning guidelines set forth in Regulation .07 of this chapter, nor does it increase the severity of the sanction.</text> </paragraph> <paragraph num="M."> <text>The Board is not required to make findings of fact or to articulate its reasoning for imposing a sanction that falls within the range of sanctions set forth in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="N."> <text>If the Board imposes a sanction that departs from the sanctioning guidelines set forth in Regulation .07 of this chapter, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> <paragraph num="O."> <text>A departure from the sanctioning guidelines set forth in Regulation .07 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="P."> <text>To resolve a pending disciplinary matter, the Board and licensee or certificate holder may agree to a consent order or the surrender of the license or certificate under terms and conditions agreed to by the Board and the licensee or certificate holder.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Aggravating and Mitigating Factors."> <paragraph num="A."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the sanctioning guidelines set forth in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Aggravating factors include, but are not limited to:</text> <paragraph num="(1)"> <text>A prior criminal or administrative discipline history;</text> </paragraph> <paragraph num="(2)"> <text>Whether the violation was committed:</text> <paragraph num="(a)"> <text>Deliberately</text> </paragraph> <paragraph num="(b)"> <text>With gross negligence; or</text> </paragraph> <paragraph num="(c)"> <text>Recklessly;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Whether the violation has the potential for, or caused, serious harm;</text> </paragraph> <paragraph num="(4)"> <text>Whether the violation was a part of a pattern of unacceptable conduct;</text> </paragraph> <paragraph num="(5)"> <text>Whether the licensee or certificate holder pursued their own financial gain over another individual’s welfare;</text> </paragraph> <paragraph num="(6)"> <text>Whether the individual affected by the violation was vulnerable;</text> </paragraph> <paragraph num="(7)"> <text>Whether the licensee or certificate holder attempted to hide the error or misconduct from clients or others;</text> </paragraph> <paragraph num="(8)"> <text>Whether the licensee or certificate holder:</text> <paragraph num="(a)"> <text>Concealed, falsified, or destroyed evidence; or</text> </paragraph> <paragraph num="(b)"> <text>Presented false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Whether the licensee or certificate holder failed to cooperate with a lawful investigation conducted by the Board; and</text> </paragraph> <paragraph num="(10)"> <text>Whether previous attempts to rehabilitate the licensee or certificate holder were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Mitigating Factors include, but are not limited to:</text> <paragraph num="(1)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The length of time since any prior violation;</text> </paragraph> <paragraph num="(3)"> <text>Whether the licensee or certificate holder self-reported to the Board;</text> </paragraph> <paragraph num="(4)"> <text>Voluntary admission of misconduct with full disclosure to the Board and cooperation with the Board’s investigation;</text> </paragraph> <paragraph num="(5)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Timely good-faith efforts to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(7)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(8)"> <text>Absence of actual or potential harm;</text> </paragraph> <paragraph num="(9)"> <text>Absence of adverse impact; and</text> </paragraph> <paragraph num="(10)"> <text>Whether the violation was an isolated incident and not likely to recur.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The existence of one or more aggravating or mitigating factors does not impose any requirement on the Board to make findings of fact or to articulate its reason for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Nothing in this regulation requires the Board to make findings of fact with respect to the existence or nature of any aggravating or mitigating factor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Imposition of a Monetary Penalty."> <paragraph num="A."> <text>Instead of or in addition to a reprimand, probation, suspension, or revocation, the Board may impose a monetary penalty in accordance with Health Occupations Article, §8-316(b), 8-6A-10(b), or 8-6B-20, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Subject to consideration of the aggravating and mitigating factors set forth in Regulation .04 of this chapter, if the Board elects to impose a monetary penalty, the Board shall use the sanctioning guidelines set forth in Regulation .07 of this chapter to determine an appropriate monetary penalty.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of a Monetary Penalty."> <paragraph num="A."> <text>The licensee or certificate holder shall pay any monetary penalty imposed by the Board under the provisions of this chapter:</text> <paragraph num="(1)"> <text>By cashier’s check or money order made payable to the Board;</text> </paragraph> <paragraph num="(2)"> <text>Within 60 days of the date of the order; and</text> </paragraph> <paragraph num="(3)"> <text>In person or by certified mail to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall pay all monies collected by the Board under the provisions of this chapter into the General Fund of the State.</text> </paragraph> <paragraph num="C."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §8-318, 8-6A-11, or 8-6B-21, Annotated Code of Maryland, does not automatically stay payment of a monetary penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="D."> <text>If a licensee or certificate holder fails to pay, in whole or in part, a monetary penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license or certificate until the monetary penalty has been paid in full.</text> </paragraph> <paragraph num="E."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sanctioning Guidelines."> <text>Subject to the provisions of this chapter, the Board may impose sanctions for violations of the Maryland Nurse Practice Act and its regulations according to the guidelines set forth in the following categories:</text> <paragraph num="A."> <text>Abuse — Physical and Psychological.</text> </paragraph> <paragraph num="B."> <text>Criminal History.</text> </paragraph> <paragraph num="C."> <text>Disciplined by Another Licensing, Military, or Disciplinary Authority.</text> </paragraph> <paragraph num="D."> <text>Diversion of Controlled Substances or Prescription Drugs or Manufacture, Sale, or Distribution of any Substance for an Illegal or Illegitimate Purpose.</text> </paragraph> <paragraph num="E."> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="F."> <text>Practice Inconsistent with Generally Accepted Standards of Care.</text> </paragraph> <paragraph num="G."> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="H."> <text>Substance Abuse.</text> </paragraph> <paragraph num="I."> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="J."> <text>Unprofessional Conduct.</text> </paragraph> <paragraph num="K."> <text>Physical or Mental Incompetence.</text> </paragraph> <paragraph num="L."> <text>Fraud, Deceit, or Misrepresentation.</text> </paragraph> <paragraph num="M."> <text>Expulsion from Safe Practice Program.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 8-205(a)(1), 8-316, 8-6A-10, 8-6B-18, 8-6C-20, and 8-6D-10, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 10, 2018 (45:18 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07M amended effective September 10, 2018 (45:18 Md. R. 834)</annotation> </annotations> </chapter> <chapter num="27" heading="Practice of Clinical Nurse Specialist"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as:</text> <paragraph num="(a)"> <text>A certified nurse midwife (CNM);</text> </paragraph> <paragraph num="(b)"> <text>A certified registered nurse anesthetist (CRNA);</text> </paragraph> <paragraph num="(c)"> <text>A certified nurse practitioner (CRNP); or</text> </paragraph> <paragraph num="(d)"> <text>A clinical nurse specialist (CNS).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Certification” means the permission to practice as a clinical nurse specialist granted by the Board to a registered nurse who:</text> <paragraph num="(a)"> <text>Met all the specified requirements of a national certifying body recognized by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Complied with the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Clinical nurse specialist” means an advanced practice registered nurse certified by the Board to practice as a clinical nurse specialist in this State.</text> </paragraph> <paragraph num="(5)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(6)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Standard of care” means the practice of clinical nurse specialist in accordance with the core competencies and behaviors specified by the National Association of Clinical Nurse Specialists (NACNS), American Nurse Credentialing Center (ANCC), American Association of Critical Care Nurses (AACN), or other national certifying body recognized by the Board.</text> </paragraph> <paragraph num="(8)"> <text>“System” means the setting within which the clinical nurse specialist is practicing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification."> <paragraph num="A."> <text>An applicant for certification as a clinical nurse specialist shall:</text> <paragraph num="(1)"> <text>Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered;</text> </paragraph> <paragraph num="(2)"> <text>Have graduated from a Board-approved graduate level education program for a clinical nurse specialist at the master’s level or higher that is accredited by;</text> <paragraph num="(a)"> <text>The National League for Nursing Accreditation Commission (NLNAC);</text> </paragraph> <paragraph num="(b)"> <text>The Commission on Nursing Education (CCNE); or</text> </paragraph> <paragraph num="(c)"> <text>Any other accrediting body recognized by the Board;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Successfully complete a national certifying exam recognized by the Board for national certification as a clinical nurse specialist in the applicant’s area of practice;</text> </paragraph> <paragraph num="(4)"> <text>Hold a current national certification as a clinical nurse specialist from a national certifying body recognized by the Board;</text> </paragraph> <paragraph num="(5)"> <text>Submit to the Board a completed application for certification as a clinical nurse specialist on a form required by the Board;</text> </paragraph> <paragraph num="(6)"> <text>Comply with all requirements set forth in COMAR 10.27.01.04;</text> </paragraph> <paragraph num="(7)"> <text>Demonstrate oral and written competency in the English language; and</text> </paragraph> <paragraph num="(8)"> <text>Pay all fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Beginning on October 1, 2012, as long as the applicant remains certified and in good standing, the Board shall deem that an applicant meets the qualifications to be certified as a clinical nurse specialist if the applicant has:</text> <paragraph num="(1)"> <text>Been licensed as a registered nurse in Maryland or has a multistate privilege to practice registered nursing;</text> </paragraph> <paragraph num="(2)"> <text>Obtained a master’s degree or higher in Nursing;</text> </paragraph> <paragraph num="(3)"> <text>Practiced as a clinical nurse specialist; and</text> </paragraph> <paragraph num="(4)"> <text>One of the following:</text> <paragraph num="(a)"> <text>An active certification as a clinical nurse specialist from a national certification body recognized by the Board;</text> </paragraph> <paragraph num="(b)"> <text>An active national certification at the highest level in the applicant’s area of practice; or</text> </paragraph> <paragraph num="(c)"> <text>A national certification at the highest level in the applicant’s area of subspecialty.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Renewal of Certification."> <paragraph num="A."> <text>Certification as a clinical nurse specialist expires at the same time as the clinical nurse specialist’s registered nursing license.</text> </paragraph> <paragraph num="B."> <text>Before a clinical nurse specialist’s certification expires, the clinical nurse specialist may renew the certification biennially if the clinical nurse specialist:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A completed renewal application for clinical nurse specialists on a form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation of current national certification as a clinical nurse specialist from a national certifying body recognized by the Board; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pays all fees.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical nurse specialists renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J — N.</text> </paragraph> <paragraph num="D."> <text>The clinical nurse specialist shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date.</text> </paragraph> <paragraph num="E."> <text>Certification as a clinical nurse specialist shall be deemed to have lapsed if the Board does not have a record of a current active national certification.</text> </paragraph> <paragraph num="F."> <text>Practicing on an expired national certification is prohibited and is subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope and Standards of Practice."> <paragraph num="A."> <text>The unique role of the clinical nurse specialist is to:</text> <paragraph num="(1)"> <text>Integrate care across the continuum and through three spheres of impact:</text> <paragraph num="(a)"> <text>The patient;</text> </paragraph> <paragraph num="(b)"> <text>The nurse; and</text> </paragraph> <paragraph num="(c)"> <text>The system; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ranges from:</text> <paragraph num="(a)"> <text>Wellness to illness; and</text> </paragraph> <paragraph num="(b)"> <text>Acute to chronic care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The clinical nurse specialist provides direct care to patients with complex needs, acts as a consultant, conducts research, and provides education and guidance for staff nurses.</text> </paragraph> <paragraph num="C."> <text>The practice of the clinical nurse specialist encompasses the continuous improvement of patient outcomes and nursing care.</text> </paragraph> <paragraph num="D."> <text>The clinical nurse specialist shall adhere to standards of clinical practice, scope of practice, and the standards of professional performance in accordance with this chapter.</text> </paragraph> <paragraph num="E."> <text>The scope of practice of the clinical nurse specialist includes, but is not limited to:</text> <paragraph num="(1)"> <text>Practicing with individual clients, families, groups, and populations of clients;</text> </paragraph> <paragraph num="(2)"> <text>Performing a comprehensive physical assessment of patients;</text> </paragraph> <paragraph num="(3)"> <text>Establishing medical diagnosis for common short-term and chronic stable health problems;</text> </paragraph> <paragraph num="(4)"> <text>Diagnosing, treating, and managing patients with acute and chronic illness or disease, or both;</text> </paragraph> <paragraph num="(5)"> <text>Ordering, performing, and interpreting laboratory tests;</text> </paragraph> <paragraph num="(6)"> <text>Ordering diagnostic tests and using the findings or results in the care of patients</text> </paragraph> <paragraph num="(7)"> <text>Initiating, monitoring, and altering appropriate therapies or treatments;</text> </paragraph> <paragraph num="(8)"> <text>Providing primary health care, including health promotion and disease prevention by assessing, educating, and providing referrals for the patient, family, and caregiver;</text> </paragraph> <paragraph num="(9)"> <text>Providing emergency care;</text> </paragraph> <paragraph num="(10)"> <text>Referring patients to appropriate licensed physicians or other health care providers as needed;</text> </paragraph> <paragraph num="(11)"> <text>Consulting or collaborating with a licensed physician or other health care provider as needed; and</text> </paragraph> <paragraph num="(12)"> <text>Creating therapeutic environments through mentoring and system changes to:</text> <paragraph num="(a)"> <text>Develop caring, evidence-based practices;</text> </paragraph> <paragraph num="(b)"> <text>Facilitate ethical decision making;</text> </paragraph> <paragraph num="(c)"> <text>Respond to diversity; and</text> </paragraph> <paragraph num="(d)"> <text>Alleviate patient distress.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Practice Before Certification."> <paragraph num="A."> <text>A registered nurse who has completed the education requirements for the advanced practice of a clinical nurse specialist and has registered for a national certifying exam recognized by the Board may practice in this State as a clinical nurse specialist graduate if the registered nurse has:</text> <paragraph num="(1)"> <text>A current license to practice registered nursing in this State or holds a multistate licensure privilege to practice registered nursing;</text> </paragraph> <paragraph num="(2)"> <text>Submitted a completed application for certification as a clinical nurse specialist graduate; and</text> </paragraph> <paragraph num="(3)"> <text>Submitted satisfactory evidence that the applicant has applied to take a national certifying exam recognized by the Board and has been accepted as a candidate for the exam.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A clinical nurse specialist graduate shall practice under the direct supervision of a certified clinical nurse specialist.</text> </paragraph> <paragraph num="C."> <text>A clinical nurse specialist graduate shall cease practice immediately if the clinical nurse specialist graduate fails the required national certification exam as required in Regulation .02A(3) of this chapter.</text> </paragraph> <paragraph num="D."> <text>A clinical nurse specialist graduate who fails the national certification exam may continue to work as a registered nurse until the clinical nurse specialist graduate passes a national certifying exam for clinical nurse specialist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Unlawful Practices."> <paragraph num="A."> <text>Unless authorized to practice under this chapter, an individual may not use the following words or abbreviations:</text> <paragraph num="(1)"> <text>Certified clinical nurse specialist;</text> </paragraph> <paragraph num="(2)"> <text>Clinical nurse specialist (CNS);</text> </paragraph> <paragraph num="(3)"> <text>Clinical Registered Nurse Specialist (CRNS);</text> </paragraph> <paragraph num="(4)"> <text>Clinical nurse specialist graduate; or</text> </paragraph> <paragraph num="(5)"> <text>Nurse specialist graduate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual certified under this chapter shall be subject to disciplinary prohibitions and sanctions set forth under Health Occupations Article, §§8-316 and 8-701 — 8-703, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1), (2), (4), and (5) and 8-302(b)(1)(iii) and (2)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 2012 (39:19 Md. R. 1236)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended as an emergency provision effective September 1, 2014 (41:19 Md. R. 1074); emergency status expired effective February 27, 2015</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C, D repealed effective April 13, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 14, 2022 (49:23 Md. R. 996)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 14, 2022 (49:23 Md. R. 996)</annotation> </annotations> </chapter> <chapter num="28" heading="Delegation of Acts by an Advanced Practice Registered Nurse"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the delegation of nursing or other technical tasks by an advanced practice registered nurse to an assistant not otherwise authorized under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>This chapter may not be construed:</text> <paragraph num="(1)"> <text>As establishing the licensure, certification, or registration of assistants by the Board;</text> </paragraph> <paragraph num="(2)"> <text>To apply to an individual who is licensed, certified, or registered by a health occupations regulatory board, or health occupation students, acting pursuant to Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>To mean that this chapter overrides, or is to be used in lieu of, more stringent regulations, policies, and procedures established by State licensure or certification requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced practice registered nurse (APRN)” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Assistant” means an individual:</text> <paragraph num="(a)"> <text>To whom only routine nursing and technical tasks are delegated by an advanced practice registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Who is trained as defined in §B(12) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Who is not licensed, certified, registered, or otherwise authorized by law by the Board, or any other State health occupations board, to practice any health occupation in the State.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Asynchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>“Delegating APRN” means an advanced practice registered nurse who directs an assistant to perform nursing and technical tasks.</text> </paragraph> <paragraph num="(6)"> <text>“Direct supervision” means oversight exercised by a delegating APRN who is:</text> <paragraph num="(a)"> <text>Personally treating the patient; and</text> </paragraph> <paragraph num="(b)"> <text>In the physical presence of the patient and the assistant.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Mechanical Act.</text> <paragraph num="(a)"> <text>“Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion.</text> </paragraph> <paragraph num="(b)"> <text>“Mechanical act” does not include:</text> <paragraph num="(i)"> <text>Selecting a drug;</text> </paragraph> <paragraph num="(ii)"> <text>Labeling;</text> </paragraph> <paragraph num="(iii)"> <text>Measuring or calculating dosages;</text> </paragraph> <paragraph num="(iv)"> <text>Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug;</text> </paragraph> <paragraph num="(v)"> <text>Substituting one dosage form of a drug for another;</text> </paragraph> <paragraph num="(vi)"> <text>Altering the route of administration; or</text> </paragraph> <paragraph num="(vii)"> <text>Counseling patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“On-site supervision” means oversight exercised by a delegating APRN who is present at the same site as the assistant and the patient and is:</text> <paragraph num="(a)"> <text>Able to be immediately available in person during the assistant’s performance of a delegated act;</text> </paragraph> <paragraph num="(b)"> <text>In the context of a synchronous telehealth interaction, able to be immediately available via secure telecommunications technology to the telehealth visit during the assistant’s performance of a delegated act; or</text> </paragraph> <paragraph num="(c)"> <text>In the context of an asynchronous telehealth interaction, able to review the assistant’s work and interact with the assistant before communication with the patient.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Site” means any facility or location, including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health care services.</text> </paragraph> <paragraph num="(10)"> <text>“Synchronous telehealth interaction” has meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Technical task” means a routine clinical act or task that does not require clinical or nursing judgment and is performed with supervision as specified within this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Trained” means possessing the knowledge, skills, and abilities, as determined by the delegating APRN, to perform delegated nursing and technical tasks.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards for Delegation."> <paragraph num="A."> <text>An APRN who delegates shall:</text> <paragraph num="(1)"> <text>Assess the risk to the patient and the outcome of the delegated acts;</text> </paragraph> <paragraph num="(2)"> <text>Delegate only those nursing and technical tasks that are customary to the practice of an APRN;</text> </paragraph> <paragraph num="(3)"> <text>Delegate only those nursing and technical tasks for which the assistant has been trained;</text> </paragraph> <paragraph num="(4)"> <text>Be responsible for the acts of the assistant;</text> </paragraph> <paragraph num="(5)"> <text>Supervise the assistant in accordance with this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>If authorized to dispense prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland, perform a final check of the prescription medication before it is provided to the patient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The responsibility for the delegated act cannot be transferred from the delegating APRN to another APRN, or to another licensed health care provider that is authorized to delegate clinical and technical tasks, without:</text> <paragraph num="(1)"> <text>The expressed consent of the other APRN or licensed health care provider; and</text> </paragraph> <paragraph num="(2)"> <text>Informing the assistant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Delegation to an Assistant."> <paragraph num="A."> <text>An APRN may not delegate nursing and technical tasks to an assistant which shall, by law or regulation, be performed only by an individual that is required to be licensed, certified, registered, or otherwise recognized pursuant to any State laws.</text> </paragraph> <paragraph num="B."> <text>An APRN may delegate nursing and technical tasks, consistent with national guidelines for nursing delegation established by the National Council of State Boards of Nursing and the approved policies and procedures of the site, in the following categories:</text> <paragraph num="(1)"> <text>Surgical technical tasks that the delegating APRN directly orders while present and personally performing the surgery in the same surgical field; and</text> </paragraph> <paragraph num="(2)"> <text>Nonsurgical technical tasks while the assistant is under the delegating APRN’s direct supervision or on-site supervision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §§B(1) and D of this regulation, an APRN shall provide at minimum on-site supervision when delegating nursing or technical tasks to an assistant, including, but not limited to, the following:</text> <paragraph num="(1)"> <text>Patient preparation for physical examination;</text> </paragraph> <paragraph num="(2)"> <text>Patient history interview;</text> </paragraph> <paragraph num="(3)"> <text>Collecting and processing specimens, such as performing phlebotomy, inoculating culture media, pregnancy tests; dipstick and microscopic urinalysis, and microbiology including rapid streptococcal testing and throat cultures;</text> </paragraph> <paragraph num="(4)"> <text>Preparing and performing laboratory tests that the APRN is satisfied the assistant is trained and qualified to perform under State and Clinical Laboratory Improvement Amendments regulations;</text> </paragraph> <paragraph num="(5)"> <text>Clinical tests including, but not limited to:</text> <paragraph num="(a)"> <text>Application of tuberculin skin tests;</text> </paragraph> <paragraph num="(b)"> <text>Electrocardiography;</text> </paragraph> <paragraph num="(c)"> <text>Administering basic pulmonary function tests; and</text> </paragraph> <paragraph num="(d)"> <text>Visual field tests;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Transmitting prescriptions to a pharmacy;</text> </paragraph> <paragraph num="(7)"> <text>Preparing and administering oral drugs;</text> </paragraph> <paragraph num="(8)"> <text>Preparing and administering injections limited to intradermal, subcutaneous, and intramuscular within the deltoid, gluteal, or vastus lateralis muscles including small amounts of local anesthetics;</text> </paragraph> <paragraph num="(9)"> <text>Establishing a peripheral intravenous line; and</text> </paragraph> <paragraph num="(10)"> <text>Injecting fluorescein-like dyes for retinal angiography.</text> </paragraph> </paragraph> <paragraph num="D."> <text>When delegating injecting intravenous drugs or contrast materials to an assistant, an APRN shall provide direct supervision.</text> </paragraph> <paragraph num="E."> <text>An APRN who is authorized to dispense prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland may delegate only mechanical acts involved in dispensing a drug.</text> </paragraph> <paragraph num="F."> <text>An APRN may not delegate to an assistant any act that requires the exercise of clinical judgment by an APRN, including, but not limited to:</text> <paragraph num="(1)"> <text>Conducting physical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics;</text> </paragraph> <paragraph num="(3)"> <text>Initiating independently any form of treatment, except for cardiopulmonary resuscitation or other forms of emergency treatment authorized to be performed by non-clinicians under State law;</text> </paragraph> <paragraph num="(4)"> <text>Establishing a diagnosis or giving clinical advice; and</text> </paragraph> <paragraph num="(5)"> <text>Providing physical therapy.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Prohibited Conduct and Penalties."> <paragraph num="A."> <text>An assistant acting beyond the scope of this chapter may be:</text> <paragraph num="(1)"> <text>Considered to be engaged in the unlicensed practice of nursing, advanced practice registered nursing, or any other health occupation recognized by the State; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to all applicable fines and penalties in accordance with Health Occupations Article, §§8-701—8-711, Annotated Code of Maryland and applicable regulations, or any other applicable provision of Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A delegating APRN, through either act or omission, facilitation, or otherwise enabling or forcing an assistant to practice beyond the scope of this chapter, may be subject to discipline as set forth in Health Occupations Article, §8-316, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A delegating APRN may not:</text> <paragraph num="(1)"> <text>Require an assistant to perform a delegated nursing or technical task; or</text> </paragraph> <paragraph num="(2)"> <text>Permit an assistant to delegate any act to another individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Enforcement."> <text>The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland and this chapter, and it may refer any complaint or investigation to any other appropriate licensing or regulatory authority in accordance with applicable laws and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6A-02, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06 adopted as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); adopted permanently effective October 27, 2025 (52:21 Md. R. 1024)</annotation> </annotations> </chapter> </subtitle> <subtitle num="28" heading="Board of Examiners in Optometry"> <chapter num="01" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of optometry using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(3)"> <text>“Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means a Maryland licensed optometrist performing telehealth services within the scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, §11-301, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through the use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Contact information;</text> </paragraph> <paragraph num="(c)"> <text>Maryland license number; and</text> </paragraph> <paragraph num="(d)"> <text>Medical specialty, if applicable;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except for interpretive services, obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of prescribed treatments;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical information, clinical data, clinical images, laboratory results, and self-reported medical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear personal health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person health care settings.</text> </paragraph> <paragraph num="D."> <text>The requirements set forth under §§A and B of this regulation may be delegated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>Subject to the provisions of Health Occupations Article, §11-208, Annotated Code of Maryland, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing treatment or issuing a prescription through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person health care services; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient or issue a prescription based solely on a static online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with Regulations .04 and .05 of this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 794)</annotation> </annotations> </chapter> <chapter num="02" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This regulation governs all optometrists licensed to practice in the State of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited” means continuing education activities produced and delivered by:</text> <paragraph num="(a)"> <text>COPE administrators in compliance with COPE accreditation criteria, standards for commercial support, and policies and procedures; or</text> </paragraph> <paragraph num="(b)"> <text>Non-COPE administrators in compliance with a program accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Council on Optometric Practitioner Education (COPE)” means the program of the Association of Regulatory Boards of Optometry, which accredits continuing education courses and activities accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system for optometrists.</text> </paragraph> <paragraph num="(3)"> <text>“Credit hour” means the increment of educational instruction time.</text> </paragraph> <paragraph num="(4)"> <text>“Diagnostic Pharmaceutical Agents (DPA) certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use diagnostic pharmaceutical agents in the practice of optometry and provides diagnostic services to patients in Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Pro bono work” means work provided in Maryland within the scope of practice of the licensee without financial reimbursement or direct financial gain.</text> </paragraph> <paragraph num="(6)"> <text>“Therapeutic Pharmaceutical Agents (TPA) certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use therapeutic pharmaceutical agents in the practice of optometry and provides therapeutic services to patients in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Registration Renewal."> <paragraph num="A."> <text>A licensee shall submit a signed form attesting to the licensee's completion of the required credit hours at the time of license renewal.</text> </paragraph> <paragraph num="B."> <text>First-Time Renewal Requirements. Licensees eligible for renewal:</text> <paragraph num="(1)"> <text>From another state licensed for less than 2 years, may earn credit hours which may be prorated for first-time renewal based on the license issuance date;</text> </paragraph> <paragraph num="(2)"> <text>That did not apply within a year of graduation and has been licensed for less than 2 years, may earn credit hours which may be prorated for first-time renewal based on the license issuance date;</text> </paragraph> <paragraph num="(3)"> <text>That have applied for renewal within 1 year of graduation from an accredited school or college of optometry may have continuing education requirements waived by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Are required to complete Implicit Bias Training and CPR certification.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall retain supporting documents for inspection by the Board for 4 years after the date of renewal.</text> </paragraph> <paragraph num="D."> <text>If a licensee submits the renewal form after the deadline, the Board shall:</text> <paragraph num="(1)"> <text>Assess a late fee; and</text> </paragraph> <paragraph num="(2)"> <text>Audit the licensee.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to meet continuing education requirements or failure to substantiate credit hours submitted upon request of the Board may result in suspension, revocation, or denial of licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Continuing Education Audit Procedure."> <paragraph num="A."> <text>At the time of renewal, the Board shall audit a minimum of 20 percent of the renewal applications.</text> </paragraph> <paragraph num="B."> <text>The Board shall send notification of audit to licensees to be audited.</text> </paragraph> <paragraph num="C."> <text>The licensee being audited shall submit to the Board, within 60 days, a report of the continuing education hours required for renewal on a form approved by the Board, along with the appropriate documentation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Required Credit and Other Course Credit."> <paragraph num="A."> <text>Credit for continuing professional education shall be:</text> <paragraph num="(1)"> <text>Accredited; or</text> </paragraph> <paragraph num="(2)"> <text>Approved by the Board solely on whether or not it constitutes improvement, advancement, and extension of one’s professional skill and knowledge relating to the practice of optometry.</text> </paragraph> </paragraph> <paragraph num="B."> <text>General Requirements.</text> <paragraph num="(1)"> <text>TPA certified optometrists shall:</text> <paragraph num="(a)"> <text>Document 50 hours of continuing professional education every 2 years, with 30 of the 50 hours focused on therapeutic topics; and</text> </paragraph> <paragraph num="(b)"> <text>Provide proof of CPR certification every renewal which may count as 3 credit hours.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>DPA certified optometrists shall:</text> <paragraph num="(a)"> <text>Document 36 hours of continuing professional education, every 2 years, with 6 of the 36 hours focused on diagnostic pharmaceuticals; and</text> </paragraph> <paragraph num="(b)"> <text>Provide proof of CPR certification every renewal which may count as 3 credit hours.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Non-Certified licensed optometrists shall:</text> <paragraph num="(a)"> <text>Document 36 hours of continuing professional education every 2 years; and</text> </paragraph> <paragraph num="(b)"> <text>Provide proof of CPR certification every renewal which may count as 3 credit hours.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board accepts:</text> <paragraph num="(a)"> <text>Only accredited or Board-approved continuing education programs; and</text> </paragraph> <paragraph num="(b)"> <text>Therapeutic courses that fall within the Ocular Disease and related Systemic Disease categories.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Trainings.</text> <paragraph num="(1)"> <text>Except for those identified in §I of this regulation, an optometrist who is issued a license by the Board may complete continuing professional education by attending in-person, virtual synchronous, or asynchronous trainings with post-test assessments conducted by an accredited administrator. The trainings may include:</text> <paragraph num="(a)"> <text>Courses given by:</text> <paragraph num="(i)"> <text>The Maryland Optometric Association;</text> </paragraph> <paragraph num="(ii)"> <text>Another Statewide association; or</text> </paragraph> <paragraph num="(iii)"> <text>Any organization approved by the Board, solely on whether or not it constitutes improvement, advancement, and extension of one’s professional skill and knowledge relating to the practice of optometry.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Observation of ophthalmic procedures at sites approved by the Board; or</text> </paragraph> <paragraph num="(c)"> <text>Other continuing professional education activities given by:</text> <paragraph num="(i)"> <text>The Maryland Optometric Association;</text> </paragraph> <paragraph num="(ii)"> <text>Another Statewide association; or</text> </paragraph> <paragraph num="(iii)"> <text>A nonprofit organization approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If requested pursuant to Regulation .04 of this chapter, an optometrist shall provide to the Board a certificate of attendance or other method of verifying attendance at an event conducted by an accredited event administrator.</text> </paragraph> <paragraph num="(3)"> <text>In accordance with §A of this regulation, events conducted by an accredited event administrator shall have Board approval.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Other than those required in §C of this regulation, credit hours may be approved for the following:</text> <paragraph num="(1)"> <text>Scheduled post-graduate or continuing education courses given by schools or colleges of optometry which have been approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Courses, either in-person, online, or both, that have received accreditation; however, the Board reserves the right to refuse credit when its established criteria are not met;</text> </paragraph> <paragraph num="(3)"> <text>Courses, either in-person, online, or both, on Practice Management directly related to optometric care, up to a maximum of 4 hours per renewal cycle;</text> </paragraph> <paragraph num="(4)"> <text>Courses given by local optometric societies or health-related sponsors, or both, upon prior approval by the Board.</text> </paragraph> <paragraph num="(5)"> <text>Courses, seminars, and lectures prepared and given by Maryland licensed optometrists for which credit will be awarded at the rate of 2 hours for preparation and 1 hour for lecture, up to a maximum of 24 hours per renewal cycle;</text> </paragraph> <paragraph num="(6)"> <text>Published papers in professional journals, papers approved for publication, or papers that have been peer-reviewed for which credit will be awarded at 2 hours per paper, up to a maximum of 12 hours per renewal cycle;</text> </paragraph> <paragraph num="(7)"> <text>Observation of ophthalmic procedures at sites approved by the Board, up to a maximum of 8 hours per renewal cycle;</text> </paragraph> <paragraph num="(8)"> <text>Courses, either in-person, online, or both, in optometric ethics, Maryland optometric jurisprudence, or both, as approved by the Board, up to a maximum of 4 hours per renewal cycle;</text> </paragraph> <paragraph num="(9)"> <text>Pro bono work providing patient eye care as outlined in §J of this regulation;</text> </paragraph> <paragraph num="(10)"> <text>Public board meeting attendance as outlined in §K of this regulation;</text> </paragraph> <paragraph num="(11)"> <text>Courses, either in-person or online, and certification in cardiopulmonary resuscitation (CPR) up to a maximum of 3 hours per renewal cycle; and</text> </paragraph> <paragraph num="(12)"> <text>Courses in cultural competency, up to a maximum of 4 hours per renewal cycle.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Credit hours will be allowed on the basis of 50 minutes being equivalent to an hour, except for pro bono work. Fractional credit hours are allowed.</text> </paragraph> <paragraph num="F."> <text>Unless Board or COPE approved, credit may not be allowed when a specific product, technique, procedure, or company is promoted or promulgated for the economic benefit of a particular person, company, group, etc.</text> </paragraph> <paragraph num="G."> <text>Unless there are extenuating circumstances, credit is allowed only in and for the license year in which the course was actually attended.</text> </paragraph> <paragraph num="H."> <text>The determination of whether or not a course meets these standards shall be entirely within the Board's province. The Board shall also determine whether or not credit for an entire course, or any lesser number of hours, may be granted.</text> </paragraph> <paragraph num="I."> <text>The Board may waive continuing education requirements for, but not limited to, licensees who:</text> <paragraph num="(1)"> <text>Have applied for licensure within 1 year of graduation from an accredited school or college of optometry; and</text> </paragraph> <paragraph num="(2)"> <text>Are renewing their license for the first time.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Pro Bono Work.</text> <paragraph num="(1)"> <text>Pro bono work shall earn 2 credit hours for each 3 hours of approved continuing education activity, up to a maximum of 12 credit hours per renewal cycle.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall provide to the Board a written application for approval of pro bono work. The application shall include:</text> <paragraph num="(a)"> <text>The place where the pro bono will be provided;</text> </paragraph> <paragraph num="(b)"> <text>The type of work to be provided;</text> </paragraph> <paragraph num="(c)"> <text>The number of hours of actual work provided for which the licensee desires credit hours; and</text> </paragraph> <paragraph num="(d)"> <text>A statement guaranteeing that the work provided no financial benefit to the licensee.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Upon completion of the work, the licensee shall obtain from the facility evidence of completion of pro bono hours.</text> </paragraph> <paragraph num="(4)"> <text>Credit hours for pro bono work are in the general category.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Public Board Meeting Attendance.</text> <paragraph num="(1)"> <text>Licensees may receive 2 credit hours for attending in its entirety an open session meeting of the Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall issue to the licensee a certificate of proof of attendance.</text> </paragraph> <paragraph num="(3)"> <text>A licensee may not earn more than 4 credit hours in this area per renewal cycle.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Proof of Education."> <paragraph num="A."> <text>Each optometrist is responsible for obtaining proof of hour credits and maintaining this documentation for inspection by the Board for 4 years after the date of renewal.</text> </paragraph> <paragraph num="B."> <text>To obtain credit, one's participation shall be attested to in writing by someone in charge of the program.</text> </paragraph> <paragraph num="C."> <text>Failure to do so shall be grounds for nonrenewal of the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Change of Annual Requirements of Number of Hours."> <text>The Board, by majority vote, may change the number of required hours of continuing education, subject to the requirements in Health Occupations Article, §11-309, Annotated Code of Maryland. An optometrist shall be notified of any change at the time of the renewal of the optometrist’s license. The change is effective for the year following that renewal.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Severability."> <text>If any provision of these regulations or the application thereof to any person or circumstances is held invalid, this invalidity may not affect other provisions or applications of these regulations which can be given effect without the invalid provision or application, and to this end, the provisions of these regulations are declared severable.</text> </regulation> <annotations> <annotation type="Authority">§§1-225, 11-101, 11-205, 11-308(c), and 11-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 9, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 6, 1983 (10:11 Md. R. 975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F adopted effective December 3, 1984 (11:24 Md. R. 2069)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 8, 1996 (23:7 Md. R. 552)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488); July 7, 2025 (52:13 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">Regulation ,03 amended effective July 7, 2025 (52:13 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 26, 2007 (34:6 Md. R. 627); October 19, 2009 (36:21 Md. R. 1591); October 1, 2012 (39:19 Md. R. 1237); May 20, 2019 (46:10 Md. R. 488); July 7, 2025 (52:13 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective April 16, 2012 (39:7 Md. R. 493)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05J adopted effective April 16, 2012 (39:7 Md. R. 493)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="03" heading="Examination and Licensing of Optometrists"> <regulation prefix="Regulation" num=".01" heading="Definition."> <text>“Board” means the Board of Examiners in Optometry.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Licensure."> <paragraph num="A."> <text>Preprofessional education—completion of 2 years of pre-optometric college study in an accredited institution of higher learning or its equivalent.</text> </paragraph> <paragraph num="B."> <text>Professional education — completion of 4 scholastic years at:</text> <paragraph num="(1)"> <text>An accredited college of optometry;</text> </paragraph> <paragraph num="(2)"> <text>An accredited university school of optometry; or</text> </paragraph> <paragraph num="(3)"> <text>An equivalent of §B(1) or (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board will accept applications for examination from graduates of those colleges of optometry or university schools of optometry:</text> <paragraph num="(1)"> <text>Endorsed by the Association of Regulatory Boards of Optometry (ARBO); and</text> </paragraph> <paragraph num="(2)"> <text>Accredited by the Council on Optometric Education of the American Optometric Association.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Licensure."> <paragraph num="A."> <text>An applicant shall complete and file an application on the form provided by the Board on request.</text> </paragraph> <paragraph num="B."> <text>The applicant shall submit the following information:</text> <paragraph num="(1)"> <text>Full name, residence, and date and place of birth;</text> </paragraph> <paragraph num="(2)"> <text>A recent photograph of the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Letters of recommendation from three individuals, excluding immediate family members, who can attest to the applicant's character and reputation;</text> </paragraph> <paragraph num="(4)"> <text>All final professional transcripts of colleges or university schools of optometry;</text> </paragraph> <paragraph num="(5)"> <text>The application fee specified in COMAR 10.28.07;</text> </paragraph> <paragraph num="(6)"> <text>Satisfactory evidence of having completed a criminal history records check in accordance with Health Occupations Article, §11-302.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(7)"> <text>Preprofessional transcripts.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application fees are not refundable.</text> </paragraph> <paragraph num="D."> <text>Applicants shall be notified whether they meet the standards adopted by the Board and qualify for licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Examination."> <paragraph num="A."> <text>The Board shall require candidates for licensure to take and pass the National Board of Examiners in Optometry’s (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections.</text> </paragraph> <paragraph num="B."> <text>A candidate for licensure shall obtain a minimum score of 75 percent on the Maryland Board of Examiners in Optometry jurisprudence examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Waiver of Examination."> <text>Standards for licensure with partial waiver of examination are set forth in Health Occupations Article, §11-305, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="License Renewal."> <paragraph num="A."> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="B."> <text>A licensee shall renew the license every 2 years, on or before July 1 of the renewal year.</text> </paragraph> <paragraph num="C."> <text>The Board shall send each licensee a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current license expires;</text> </paragraph> <paragraph num="(2)"> <text>Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee as specified in COMAR 10.28.07.02.</text> </paragraph> </paragraph> <paragraph num="D."> <text>At least 30 days before the current license or registration expires, the Board shall send the renewal notice by electronic means or first-class mail to the last known electronic or physical address of the licensee.</text> </paragraph> <paragraph num="E."> <text>The failure to receive a renewal notice does not excuse a licensee from complying with §B of this regulation.</text> </paragraph> <paragraph num="F."> <text>Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.28.02.</text> </paragraph> <paragraph num="G."> <text>After the expiration date of the license, the optometrist is no longer licensed to practice optometry in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Change of Mailing Address, Legal Name, or Email Address."> <paragraph num="A."> <text>A licensed optometrist shall give the Board written notice within 30 days of a change of:</text> <paragraph num="(1)"> <text>Mailing address;</text> </paragraph> <paragraph num="(2)"> <text>Legal name; or</text> </paragraph> <paragraph num="(3)"> <text>Email address if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a $50 fee as set forth under COMAR 10.28.07.02.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205 and 11-302—11-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 21, 1980 (7:6 Md. R. 608)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 13, 1984 (11:3 Md. R. 202); January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 13, 1984 (11:3 Md. R. 202); January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, D amended effective January 22, 1990 (17:1 Md. R. 70)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 7, 1994 (21:22 Md. R. 1876)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 19, 2001 (28:3 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 7, 2025 (52:13 Md. R. 656)</annotation> </annotations> </chapter> <chapter num="04" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Examiners in Optometry.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in cases which the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference committee” means a committee composed of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(7)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease doing a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of optometry.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Charging document” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Optometry Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth sections of the Maryland Optometry Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Complaint” means a written allegation received by the Board that a licensee may have violated the Maryland Optometry Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Consent order” means a public record issued by the Board which is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(11)"> <text>“Contested case” means a proceeding conducted pursuant to the Administrative Procedure Act.</text> </paragraph> <paragraph num="(12)"> <text>“Disposition agreement” means a formal nonpublic agreement, entered into with an impaired licensee in lieu of formal disciplinary action, where the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(13)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board is authorized to do by law.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Imperatively requires emergency action” means a finding by the Board that an emergency action be taken against a licensee pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(15)"> <text>“Informal action” means that the Board closes a case, without taking any formal disciplinary action or issuing a final order, by imposing a disciplinary sanction consisting of a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment;</text> </paragraph> <paragraph num="(c)"> <text>Cease and desist letter; or</text> </paragraph> <paragraph num="(d)"> <text>Consent agreement.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Investigation” means the gathering of information to assist the Board in determining whether there is reasonable cause to charge a licensee with a violation of the Maryland Optometry Act.</text> </paragraph> <paragraph num="(17)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing the case, when the Board believes a licensee has engaged in conduct which violates the Maryland Optometry Act.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” includes admonishment of the licensee not to repeat the actions.</text> </paragraph> <paragraph num="(c)"> <text>“Letter of admonishment” may include an agreement that a licensee perform certain conditions in lieu of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Letter of education” means informal action consisting of a nonpublic letter:</text> <paragraph num="(a)"> <text>Issued by the Board when the Board does not believe that conduct rose to the level of a violation of the Maryland Optometry Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of optometry.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the licensee's license to practice optometry, which may include conditions for the Board's acceptance of the surrender as a resolution of the case.</text> </paragraph> <paragraph num="(20)"> <text>“Licensure” means permission to engage in a health care profession regulated by the Board, which is in any form including a certificate, registration, or license.</text> </paragraph> <paragraph num="(21)"> <text>“Maryland Optometry Act” means Health Occupations Article, Title 11, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, change in licensure status, or some other benefit sought by the licensee.</text> </paragraph> <paragraph num="(23)"> <text>“Penalty” means a monetary or administrative penalty imposed pursuant to Health Occupations Article, §11-314, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Post-deprivation hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(25)"> <text>“Predeprivation hearing” means a non-evidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why it should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action which the Board is authorized by law to take.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Preliminary investigation” means the gathering of information to be used by the Board to determine whether the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Optometry Act.</text> </paragraph> <paragraph num="(27)"> <text>“Probation” means a sanction imposed by the Board in a public final order where the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions in order to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Prohibited act” means any conduct specified in the Maryland Optometry Act which can result in sanctions or penalties.</text> </paragraph> <paragraph num="(29)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public pursuant to the State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(30)"> <text>“Recommended decision” means a nonpublic record issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, and a proposed sanction, or any combination of these actions.</text> </paragraph> <paragraph num="(31)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason which may interfere with the Board member's participation in a case.</text> </paragraph> <paragraph num="(32)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, who has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of the Maryland Optometry Act;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential emergency suspension pursuant to State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Notified as to a potential violation of Health Occupations Article, §11-501, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Revocation” means the removal of an optometrist's license to practice optometry.</text> </paragraph> <paragraph num="(34)"> <text>“Sanction” means an action by the Board which:</text> <paragraph num="(a)"> <text>Reprimands;</text> </paragraph> <paragraph num="(b)"> <text>Places on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fines;</text> </paragraph> <paragraph num="(d)"> <text>Suspends or revokes a license; or</text> </paragraph> <paragraph num="(e)"> <text>Disciplines by a consent order.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Show cause hearing” means a non-evidentiary hearing held before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board is legally authorized to take.</text> </paragraph> <paragraph num="(36)"> <text>“Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions.</text> </paragraph> <paragraph num="(37)"> <text>“Summary suspension” means the indefinite suspension of a license pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, where the Board believes that the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(38)"> <text>“Surrender” means the voluntary relinquishing of a license to practice optometry which may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(39)"> <text>“Suspension” means a temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specific period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings' proceedings involving the adjudication of a Board contested case and the administrative law judge's recommended decision are confidential and the respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, the respondent shall be represented in proper person or by an attorney who has been:</text> <paragraph num="(1)"> <text>Admitted to the Maryland Bar; or</text> </paragraph> <paragraph num="(2)"> <text>Specially admitted to practice law pursuant to Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General in all proceedings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings under Health Occupations Article, §11-313, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Make a preliminary review of each complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Recommend that cases involving complaints over which the Board has no jurisdiction be closed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee who is the subject of the complaint to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(3)"> <text>Board subpoenas may be issued by the Board over the signature of the administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>For each complaint, after reviewing any completed investigative information or reports, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(c)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(d)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(e)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(f)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §11-313, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not it has voted to charge a licensee with violations of the Maryland Optometry Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(a)"> <text>Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Hand delivered in person.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Optometry Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing; and</text> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation or attempt any other reasonable means to effect service, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> <paragraph num="(4)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board, or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board, or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(a)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>The Board may deny a respondent's request for a case resolution conference except as provided in §E(1) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="(5)"> <text>The Board is not bound by the recommendations of the case resolution conference committee and may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or on a notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether or not the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Proceedings under Health Occupations Article, §11-313, Annotated Code of Maryland — Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>The Board may require conditions for surrender of a license, including, but not limited to:</text> <paragraph num="(a)"> <text>The admission of a violation of the Maryland Optometry Act;</text> </paragraph> <paragraph num="(b)"> <text>The admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not again apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A letter of surrender is a final order of the Board and is a public record pursuant to State Government Article, §10-611, Annotated Code of Maryland, unless the Board determines that disclosure of the surrender is not in the public interest.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted pursuant to State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings are not open to the public and all records, including the recommended decision, shall be treated as confidential and sealed.</text> </paragraph> <paragraph num="(4)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §B(4)(a) — (c) of this regulation pursuant to the Board's delegation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>A licensee against whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Optometry Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages. The exceptions shall state with particularity:</text> <paragraph num="(a)"> <text>The finding of fact, conclusion of law, or other matter excepted to; and</text> </paragraph> <paragraph num="(b)"> <text>The relevant portions of the record supporting the party's exception.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages. The answer shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party's response to an answer to exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board following receipt of the parties' exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient progress of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in any answer to exceptions, or in the hearing on exceptions, reference any document or other evidence or offer any exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>Upon a finding that there has been a violation of the Maryland Optometry Act, the Board may order that the licensee be fined, reprimanded, or placed on probation, or that the license be suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Pursuant to its authority under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of an intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of an intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include, but is not limited to:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and which includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board:</text> <paragraph num="(i)"> <text>To show cause why the Board should not execute the order of summary suspension; and</text> </paragraph> <paragraph num="(ii)"> <text>Which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By any other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity to Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>Predeprivation Show Cause Hearing Before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the presiding Board member believes that the documents or exhibits are necessary in order for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension of a License Without Prior Notice or an Opportunity To Be Heard.</text> <paragraph num="(1)"> <text>In extraordinary circumstances, the Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend the license or providing a respondent with an opportunity for a predeprivation hearing if:</text> <paragraph num="(a)"> <text>The Board determines that the public health, safety, and welfare requires the immediate suspension of the license and that prior notice and an opportunity to be heard is not feasible;</text> </paragraph> <paragraph num="(b)"> <text>The order of summary suspension is served upon the respondent within 24 hours after its execution; and</text> </paragraph> <paragraph num="(c)"> <text>The respondent is provided with an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the respondent requests a hearing pursuant to §D(1)(c) of this regulation, that hearing shall be conducted before the Board as provided in §C(2) of this regulation and shall provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding pursuant to §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings are final orders of the Board and public records pursuant to State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Post-Deprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license pursuant to §C or D of this regulation, the respondent shall be provided with the opportunity for an evidentiary hearing before the Board or before an administrative law judge, if the Board delegates the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after the respondent's request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted pursuant to the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board has delegated the matter to the Office of Administrative Hearings, the administrative law judge shall issue to the Board a recommended decision with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a) — (c) of this regulation pursuant to the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge's determination as to the merits of the summary suspension shall be based only on those parts of the record that were available to the Board at the time it voted for the summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exceptions to the recommended decision as provided in State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a post-deprivation evidentiary hearing is a final order of the Board and is a public record pursuant to State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board deems appropriate, including:</text> <paragraph num="(1)"> <text>Re-education or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Providing free optometric services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Practicing under supervision;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board;</text> </paragraph> <paragraph num="(6)"> <text>Periodic review of a licensee's clinical practices or billing;</text> </paragraph> <paragraph num="(7)"> <text>Periodic audits of a licensee's billing practices;</text> </paragraph> <paragraph num="(8)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(10)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(11)"> <text>Any other condition the Board deems appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when the:</text> <paragraph num="(1)"> <text>Specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>Licensee has successfully completed the conditions or acts required for termination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If, at any time, the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action provided for in the final order or consent order in the event of a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board deems appropriate and which the Board is authorized to take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts that constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .06B of this chapter.</text> </paragraph> <paragraph num="G."> <text>If the Board determines that the respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action provided for in the consent order or final order in the event of a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose any sanction or take any other action that the Board deems appropriate and is authorized to take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Restoration of a License."> <paragraph num="A."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for a lifting of a suspension of a license or a reinstatement following revocation or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee who petitions the Board for reinstatement pursuant to terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board shall apply for reinstatement only pursuant to those terms and conditions.</text> </paragraph> <paragraph num="(3)"> <text>A licensee whose license has been revoked or surrendered for 3 years or more before filing a petition for reinstatement is not eligible for reinstatement but instead shall apply for initial licensure.</text> </paragraph> <paragraph num="(4)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement set out in COMAR 10.28.05; and</text> </paragraph> <paragraph num="(c)"> <text>Achieve a passing score on the Board's law examination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Opportunity for a Hearing.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, that notice shall be served as provided for in Regulations .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the legal basis for the Board's belief that the applicant is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts which the Board believes support the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or be delegated to an administrative law judge and conducted pursuant to the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, it may impose any restrictions or conditions on the license or the licensee's practice that it deems appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §11-318, and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Imposition of Penalties."> <text>The Board may impose a civil monetary penalty in lieu of or in addition to a disciplinary sanction authorized by Health Occupations Article, §11-313, Annotated Code of Maryland as provided in COMAR 10.28.13.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Consideration and Notice of Board Files."> <text>In any matter governed by this chapter, the Board may take official notice of any information contained in the Board's files.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205, 11-313, and 11-315;State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 11, 1983 (10:7 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 repealed and new Regulations .01 — .12 adopted effective September 3, 2001 (28:17 Md. R. 1556)</annotation> </annotations> </chapter> <chapter num="05" heading="Inactive Status and Reinstatement of Expired Licenses"> <regulation prefix="Regulation" num=".01" heading="Inactive Status."> <text>The Board shall place a license on inactive status, if the licensee submits to the Board:</text> <paragraph num="A."> <text>An application for inactive status on the form required by the Board; and</text> </paragraph> <paragraph num="B."> <text>The inactive status fee required by COMAR 10.28.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for Active Licensure by Optometrist on Inactive Status."> <text>An optometrist who is on inactive status may apply for reinstatement of active licensure. The Board shall issue an active license if the optometrist:</text> <paragraph num="A."> <text>Submits to the Board satisfactory proof of completion of continuing education hours required of a practitioner on active status during the period of inactivity, not to exceed 125 hours; and</text> </paragraph> <paragraph num="B."> <text>Pays to the Board the reinstatement fee required by COMAR 10.28.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reinstatement of Expired License."> <paragraph num="A."> <text>Any optometrist whose license has been expired for less than 5 years and who has not been put on inactive status may apply for reinstatement of their license. The Board may reinstate the license if the optometrist:</text> <paragraph num="(1)"> <text>Submits to the Board satisfactory proof of having subsequently met the continuing education requirements required of a practitioner on active status during the period the license was expired, not to exceed 125 hours;</text> </paragraph> <paragraph num="(2)"> <text>Otherwise meets the renewal requirements set forth in Health Occupations Article, §11-308, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Board the fee for the same number of renewal cycles lapsed plus $50.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may reinstate the license of any optometrist whose license has been expired for 5 years or more and who has not been put on inactive status, or practiced optometry, only if the optometrist passes an examination recognized by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §11-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 11, 1983 (10:7 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 7, 2025 (52:13 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 4, 2002 (29:4 Md. R. 417)</annotation> </annotations> </chapter> <chapter num="06" heading="Examination of Patients by Optometrists, Maintenance of Records, and Keeping of Certain Instrumentation and Equipment"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish criteria the Board considers necessary to perform a minimum optometric examination, maintain certain records, and have on hand certain instrumentation and equipment required to carry out procedures for the minimum examination.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Patient History."> <text>An optometrist shall review the patient's history and shall create a written, oral, or electronic record of the following:</text> <paragraph num="A."> <text>Previous vision examinations, prescriptions, treatment programs;</text> </paragraph> <paragraph num="B."> <text>Patient's general health history including ocular health, familial involvements, current medications, and allergy history;</text> </paragraph> <paragraph num="C."> <text>Patient's primary complaint, symptoms, or other reason for consulting the practitioner;</text> </paragraph> <paragraph num="D."> <text>Other information bearing on visual tasks to be performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examination."> <text>A licensee shall perform all necessary tests, evaluations, and observations in accordance with Health Occupations Article, §11-208(a), Annotated Code of Maryland, to ensure appropriate optometric management of the patient's ocular, systemic, visual, and psychosocial conditions.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Records."> <text>A licensed optometrist shall maintain thorough records of all testing procedures, results, and case dispositions in accordance with Health-General Article, §4-403, Annotated Code of Maryland. The optometrist shall record all tests, evaluations, and observations performed, along with assessment and plan.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Equipment."> <text>A licensed optometrist shall have on hand all necessary equipment in good working condition to perform the procedures as required in Regulations .03 and .04 of this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205 and 11-208, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 4, 1984 (11:11 Md. R. 962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective November 7, 1994 (21:22 Md. R. 1876)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1876)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective November 7, 1994 (21:22 Md. R. 1876)</annotation> </annotations> </chapter> <chapter num="07" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all persons licensed as optometrists by the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Application fee—$300;</text> </paragraph> <paragraph num="B."> <text>Biennial renewal license fee— $600;</text> </paragraph> <paragraph num="C."> <text>Inactive license fee—$250;</text> </paragraph> <paragraph num="D."> <text>Late fee (payable if renewal fee is received within the 30-day grace period)—$100;</text> </paragraph> <paragraph num="E."> <text>Reinstatement fee (payable after failure to renew license for less than 5 years). Licensee shall also pay renewal fees for number of renewal cycles lapsed—$50;</text> </paragraph> <paragraph num="F."> <text>Reinstatement fee to active licensure (payable to change from inactive status to active status licensure)—$100;</text> </paragraph> <paragraph num="G."> <text>Fee for failure to maintain correct mailing address, name, or email address with the Board—$50; and</text> </paragraph> <paragraph num="H."> <text>License verification fee (per state or entity)—$25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Examiners in Optometry. All licensees and applicants will be notified of the change.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205, 11-207, and 11-302—11-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 22, 1984 (11:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); amended permanently effective January 2, 1993 (19:25 Md. R. 2206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 4, 2002 (29:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective January 30, 2003 (30:4 Md. R. 314); amended permanently effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 11, 2003 (30:24 Md. R. 1741); July 7, 2025 (52:13 Md. R. 656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H repealed effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I, J repealed effective October 19, 2009 (36:21 Md. R. 1591)</annotation> </annotations> </chapter> <chapter num="08" heading="Licensure Eligibility: Out-of-State Applicants"> <regulation prefix="Regulation" num=".01" heading="Definition."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Active practice” means practices optometry for at least a total of 500 hours within 3 consecutive years, immediately before applying for licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application."> <paragraph num="A."> <text>An applicant for licensure under this chapter shall:</text> <paragraph num="(1)"> <text>Complete and submit to the Board an application;</text> </paragraph> <paragraph num="(2)"> <text>Pay the application fee required by COMAR 10.28.07.02; and</text> </paragraph> <paragraph num="(3)"> <text>Submit proof that the applicant meets the requirements of Health Occupations Article, §11-305, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall submit the following documentation with the application:</text> <paragraph num="(1)"> <text>A copy of a current license from another state;</text> </paragraph> <paragraph num="(2)"> <text>An affidavit from the other state licensing board attesting that the applicant became licensed in the other state by passing an examination approved by the board of optometry in that state;</text> </paragraph> <paragraph num="(3)"> <text>An affidavit from a colleague, employer, or other source approved by the Board attesting that the applicant has:</text> <paragraph num="(a)"> <text>Engaged in active practice immediately before applying for licensure under this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Was a teaching optometrist, a military optometrist, a supervisor or administrative optometrist, or a researcher in optometry for 3 years immediately before applying for licensure under this chapter;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An affidavit from the other state licensing board attesting that the applicant has met the continuing education requirements for the state in which the applicant has been practicing; and</text> </paragraph> <paragraph num="(5)"> <text>Proof of the equivalent of 3 years of continuing education hours as required of optometrists in Maryland in courses approved by the Board if the other state does not require continuing education hours.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examination."> <text>An approved applicant for licensure under this chapter shall:</text> <paragraph num="A."> <text>Be given a Maryland Board of Examiners in Optometry jurisprudence examination; and</text> </paragraph> <paragraph num="B."> <text>Obtain a minimum score of 75 percent.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205 and 11-302—11-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 11, 1985 (12:5 Md. R. 483)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective August 28, 1995 (22:17 Md. R. 1318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective March 4, 2002 (29:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 28, 1995 (22:17 Md. R. 1318)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 26, 2007 (34:6 Md. R. 627)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 7, 2025 (52:13 Md. R. 656)</annotation> </annotations> </chapter> <chapter num="09" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern advertising by optometrists in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means calling to the attention of the public the services one has to offer, including, but not limited to, by written, oral, or electronic methods.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(3)"> <text>“Optometrist” means an individual who holds a current license to practice optometry in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>An optometrist may advertise the optometrist's services subject to the provisions of this regulation.</text> </paragraph> <paragraph num="B."> <text>An advertisement may not contain statements:</text> <paragraph num="(1)"> <text>Containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Intended to or likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to a layman;</text> </paragraph> <paragraph num="(5)"> <text>Conveying the impression that the optometrist could influence improperly any public body, official, corporation, or any person on behalf of a patient;</text> </paragraph> <paragraph num="(6)"> <text>Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent person to misunderstand or be deceived;</text> </paragraph> <paragraph num="(7)"> <text>Containing representations that the optometrist is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States;</text> </paragraph> <paragraph num="(8)"> <text>That fail to state that the practitioner is an optometrist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An optometrist shall also be accountable under this regulation if the optometrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <paragraph num="A."> <text>An optometrist may not engage in solicitation, including but not limited to in-person, telephone, facsimile, internet, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation, or overreaching;</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .03B.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An optometrist shall also be accountable under this regulation if the optometrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties for Violation."> <text>A violation of these regulations pertaining to the use of advertising shall constitute unprofessional conduct and may result in disciplinary action against the optometrist under Health Occupations Article, §§11-205 and 11-313, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205 and 11-313, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 7, 1987 (14:18 Md. R. 1966)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 4, 2002 (29:4 Md. R. 417)</annotation> </annotations> </chapter> <chapter num="10" heading="Optometrist Accountability"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all optometrists licensed to practice in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Practitioner Identification."> <text>Licensed practicing optometrists shall, in an appropriate manner, ensure that the patient knows the identity of the provider of optometric care by providing that:</text> <paragraph num="A."> <text>The names of the optometrists providing services are conspicuously posted in the office;</text> </paragraph> <paragraph num="B."> <text>The name of the licensed optometrist, or some other method of identifying the optometrist providing the optometric services, appears on any record required by law or regulation; and</text> </paragraph> <paragraph num="C."> <text>Treatment records are maintained and clearly identify the licensed optometrist who recommends, instructs, or prescribes vision care for the patient.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205(a) and 11-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 7, 1987 (14:18 Md. R. 1967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> </annotations> </chapter> <chapter num="11" heading="Use of Diagnostic Pharmaceutical Agents"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Optometric management of ocular disease” means the use of optometric services and techniques to determine the most appropriate and timely referral for ocular disease.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Diagnostic Pharmaceutical Agents."> <paragraph num="A."> <text>An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents:</text> <paragraph num="(1)"> <text>Agents directly or indirectly affecting the pupil of the eye, including, but not limited to, the mydriatics and cycloplegics listed below:</text> <paragraph num="(a)"> <text>Phenylephrine hydrochloride (2.5 percent);</text> </paragraph> <paragraph num="(b)"> <text>Hydroxyamphetamine hydrobromide (1.0 percent);</text> </paragraph> <paragraph num="(c)"> <text>Cyclopentolate hydrochloride (0.5—2.0 percent);</text> </paragraph> <paragraph num="(d)"> <text>Tropicamide (0.5 and 1.0 percent);</text> </paragraph> <paragraph num="(e)"> <text>Cyclopentolate hydrochloride (0.2 percent) with phenylephrine hydrochloride (1.0 percent);</text> </paragraph> <paragraph num="(f)"> <text>Dapiprazole hydrochloride (0.5 percent);</text> </paragraph> <paragraph num="(g)"> <text>Hydroxyamphetamine hydrobromide (1.0 percent) and tropicamide (0.25 percent); and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Agents directly or indirectly affecting the sensitivity of the cornea, including, but not limited to, the:</text> <paragraph num="(a)"> <text>Topical anesthetics listed below:</text> <paragraph num="(i)"> <text>Proparacaine hydrochloride (0.5 percent); and</text> </paragraph> <paragraph num="(ii)"> <text>Tetracaine hydrochloride (0.5 percent);</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Diagnostic topical anesthetic and dye combinations listed below:</text> <paragraph num="(i)"> <text>Benoxinate hydrochloride (0.4 percent)—fluorescein sodium (0.25 percent); and</text> </paragraph> <paragraph num="(ii)"> <text>Proparacaine hydrochloride (0.5 percent)—fluorescein sodium (0.25 percent).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The optometrist may use the diagnostic pharmaceutical agents listed in §A of this regulation in strengths not greater than the strengths indicated unless clinically indicated.</text> </paragraph> <paragraph num="C."> <text>The optometrist may not dispense diagnostic pharmaceutical agents to patients for self-administration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Certification."> <paragraph num="A."> <text>The Board will certify an optometrist licensed to practice in Maryland as qualified to administer diagnostic pharmaceutical agents if the licensed optometrist meets one of the following criteria:</text> <paragraph num="(1)"> <text>Graduation from an accredited school of optometry within 7 years before applying for certification in Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Certification to use diagnostic pharmaceutical agents in another state which included completion of not less than 70 credit hours in diagnostic pharmaceutical agents if the optometrist:</text> <paragraph num="(a)"> <text>Submits to the Board proof of certification to use diagnostic pharmaceutical agents in the other state.</text> </paragraph> <paragraph num="(b)"> <text>Submits to the Board documentation that the original certification included at least 70 credit hours in diagnostic pharmaceutical agents. This documentation may be from either:</text> <paragraph num="(i)"> <text>The state board that granted the original certification;</text> </paragraph> <paragraph num="(ii)"> <text>The college, university, association, or other sponsors of the 70 credit hours in diagnostic pharmaceutical agents; or</text> </paragraph> <paragraph num="(iii)"> <text>Any other organization approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Successful completion of a course in diagnostic pharmaceutical agents of at least 70 credit hours given by an accredited college or faculty approved by the Board within 7 years before applying for certification in Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The credit hours taken for initial certification in diagnostic pharmaceutical agents may be included as part of the hours of continuing education required for biennial license renewal.</text> </paragraph> <paragraph num="C."> <text>To complete the certification process, the optometrist shall submit proof of current certification in cardiopulmonary resuscitation to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Renewal of Certification."> <paragraph num="A."> <text>An optometrist certified under this chapter shall complete 6 credit hours of continuing education every 2 years in the use of diagnostic pharmaceutical agents in the diagnosis and optometric management of ocular disease.</text> </paragraph> <paragraph num="B."> <text>The 6 credit hours of continuing education relating to the use of diagnostic pharmaceutical agents required every 2 years to maintain certification may be included as part of the hours of continuing education required for biennial license renewal.</text> </paragraph> <paragraph num="C."> <text>An optometrist is responsible for maintaining proficiency with the current CPR procedures as recommended by the American Heart Association.</text> </paragraph> <paragraph num="D."> <text>The Board shall grant 3 continuing education hours for CPR recertification courses per biennial license renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reporting."> <text>An optometrist certified to use diagnostic pharmaceutical agents shall report to the Board, on the form provided by the Board, any incident of adverse reaction to the administration of diagnostic pharmaceutical agents.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-101, 11-205, and 11-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 14, 1990 (17:9 Md. R. 1090)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective November 20, 1994 (21:33 Md. R. 1933); July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 4, 2002 (29:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 20, 1994 (21:33 Md. R. 1933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective July 7, 2025 (52:13 Md. R. 656)</annotation> </annotations> </chapter> <chapter num="12" heading="Therapeutic Pharmaceutical Agents"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adverse drug reaction” means a physical or psychological reaction experienced by a patient which:</text> <paragraph num="(a)"> <text>Results from the administration of diagnostic or therapeutic pharmaceutical agents;</text> </paragraph> <paragraph num="(b)"> <text>Poses a threat to the health of the patient; and</text> </paragraph> <paragraph num="(c)"> <text>Requires treatment or medical intervention.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Adverse reaction” means the unintended or unexpected effect of treatment on a patient caused by or resulting from:</text> <paragraph num="(a)"> <text>An adverse drug reaction;</text> </paragraph> <paragraph num="(b)"> <text>The removal of a superficial foreign body from the eye; or</text> </paragraph> <paragraph num="(c)"> <text>The ordering of a laboratory test.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(4)"> <text>“Diagnostic pharmaceutical agent (DPA)” means a medication that:</text> <paragraph num="(a)"> <text>Directly or indirectly affects the pupil of the eye as defined in COMAR 10.28.11;</text> </paragraph> <paragraph num="(b)"> <text>Directly or indirectly affects the sensitivity of the cornea as defined in COMAR 10.28.11; or</text> </paragraph> <paragraph num="(c)"> <text>Stains the ocular surface.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Ophthalmologist” means a physician who practices in the specialty of ophthalmology and who is licensed by the Maryland Board of Physicians.</text> </paragraph> <paragraph num="(6)"> <text>“Primary open angle glaucoma” means glaucomatous changes characterized by:</text> <paragraph num="(a)"> <text>Adult onset;</text> </paragraph> <paragraph num="(b)"> <text>The presence of open, normal appearing angles as demonstrated by gonioscopy, and not otherwise explained; and</text> </paragraph> <paragraph num="(c)"> <text>One or more of the following:</text> <paragraph num="(i)"> <text>The appearance of optic disc damage or optic nerve fiber layer damage as evidenced by the size or shape of the optic disc cup, thinning or notching of the optic disc rim, progressive changes in the appearance of the optic disc cup, optic disc hemorrhage, or nerve fiber layer defects, seen clinically or via imaging;</text> </paragraph> <paragraph num="(ii)"> <text>The presence of abnormalities in the visual field including arcuate defect, nasal step, paracentral scotoma, or general depression, in the absence of other causes or explanations for a visual field defect; or</text> </paragraph> <paragraph num="(iii)"> <text>Intraocular pressure that is thought to pose a threat to the health of the optic nerve.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Therapeutic pharmaceutical agent (TPA)” means a medication used for the treatment of a disease or condition of the eye as specified in Health Occupations Article, §11-404.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Therapeutically certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use therapeutic pharmaceutical agents in the practice of optometry and provides therapeutic services to patients in Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“TPA record” means the optometrist's documentation of a patient's visit, the result of which involved the prescribing of medication or the performance of a procedure for treatment of a medical eye condition by a therapeutically certified optometrist.</text> </paragraph> <paragraph num="(11)"> <text>“Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Certification."> <paragraph num="A."> <text>Except for an optometrist who qualifies under §C or D of this regulation, the Board shall certify an optometrist licensed to practice in Maryland as qualified to use TPAs if the licensed optometrist submits to the Board evidence satisfactory to the Board that the optometrist:</text> <paragraph num="(1)"> <text>Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs;</text> </paragraph> <paragraph num="(2)"> <text>Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and</text> </paragraph> <paragraph num="(3)"> <text>Is currently certified by the Board to administer topical ocular DPAs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may consider pharmacology courses that an optometrist successfully completed during a course of study at an accredited school of optometry recognized by the Board when calculating the 110 hours of Board-approved TPA education required under §§A(1) and D(1) of this regulation. If accepted by the Board, then each:</text> <paragraph num="(1)"> <text>Semester credit hour will equal 15 hours of TPA education; and</text> </paragraph> <paragraph num="(2)"> <text>Quarter credit hour will equal 10 hours of TPA education.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall certify an optometrist who has graduated from an accredited school of optometry within 3 years before applying for certification to use TPAs if the optometrist:</text> <paragraph num="(1)"> <text>Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Completes the process to become certified to use TPAs within 3 years of the date of graduation from an accredited school of optometry.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If an optometrist who has graduated on or after July 1, 2005, from an accredited school of optometry recognized by the Board, is not certified within 3 years of graduation, the Board shall certify the optometrist to use TPAs if the optometrist:</text> <paragraph num="(1)"> <text>Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs;</text> </paragraph> <paragraph num="(2)"> <text>Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and</text> </paragraph> <paragraph num="(3)"> <text>Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The credit hours taken for initial certification in TPAs may be included as part of the hours of continuing education required for biennial license renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Renewal of Certification."> <paragraph num="A."> <text>An optometrist certified by the Board under this chapter shall complete 50 hours of continuing education during the 2 year licensure period in order to renew the optometrist's license.</text> </paragraph> <paragraph num="B."> <text>An optometrist certified by the Board under this chapter shall complete 30 hours of continuing education in the use and management of TPAs, during the 2-year licensure period.</text> </paragraph> <paragraph num="C."> <text>The Board shall count the 30 hours of continuing education in TPAs toward the 50 hours of continuing education required for biennial renewal.</text> </paragraph> <paragraph num="D."> <text>A therapeutically certified optometrist shall be certified in CPR and shall verify this certification on request by the Board.</text> </paragraph> <paragraph num="E."> <text>Unless there are extenuating circumstances acceptable to the Board, the Board shall revoke the TPA certification of an optometrist who does not fulfill the requirements for renewal of the TPA certification.</text> </paragraph> <paragraph num="F."> <text>TPA Self-Assessment. At the time of license renewal, the therapeutically certified optometrist shall complete a self-assessment checklist provided by the Board to evaluate the following aspects of the optometrist’s practice utilizing TPAs, including but not limited to:</text> <paragraph num="(1)"> <text>Legibility and completeness of TPA records;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of patient visits, services rendered, and communications;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of subjective complaints, objective findings, clinical assessments relating to the findings of the diagnosis, and the plan;</text> </paragraph> <paragraph num="(4)"> <text>A written office plan for handling emergencies;</text> </paragraph> <paragraph num="(5)"> <text>A system for patients to reach the optometrist, or to access care, in the event of an ocular emergency;</text> </paragraph> <paragraph num="(6)"> <text>A systematic discarding of expired medications;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of current CPR certification;</text> </paragraph> <paragraph num="(8)"> <text>An infection control policy;</text> </paragraph> <paragraph num="(9)"> <text>Patient confidentiality;</text> </paragraph> <paragraph num="(10)"> <text>A patient tracking system that enables identification and follow-up to ensure treatment of patients who:</text> <paragraph num="(a)"> <text>Are being followed or referred out for emergency sight or life-threatening conditions; or</text> </paragraph> <paragraph num="(b)"> <text>Fail to keep appointments;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Procedures for appropriate termination of the doctor-patient relationship when necessary;</text> </paragraph> <paragraph num="(12)"> <text>Satisfactory explanation of the treatment plan so that the patient knows and understands the nature of the patient’s problem or problems and the goals of the treatment regimen; and</text> </paragraph> <paragraph num="(13)"> <text>Advice to patients regarding the importance of progress examinations and follow-up care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Quality for Therapeutically Certified Optometrists and Optometric Care."> <paragraph num="A."> <text>The therapeutically certified optometrist shall provide clinical therapeutic eye care consistent with published, universally accepted practice or clinical guidelines and standards of care.</text> </paragraph> <paragraph num="B."> <text>The therapeutically certified optometrist shall adhere to the additional guidelines and standards of care given in §§C—T of this regulation.</text> </paragraph> <paragraph num="C."> <text>The therapeutically certified optometrist shall ensure that:</text> <paragraph num="(1)"> <text>TPA records are consistent with the Subjective, Objective, Assessment, and Plan (SOAP) format;</text> </paragraph> <paragraph num="(2)"> <text>Assessment and plans are consistent with the patient's subjective and clinical findings; and</text> </paragraph> <paragraph num="(3)"> <text>TPA records are complete and legible.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The therapeutically certified optometrist shall document the following data, if applicable, for each TPA patient visit or communication:</text> <paragraph num="(1)"> <text>Date of service;</text> </paragraph> <paragraph num="(2)"> <text>Current Procedural Terminology (CPT) Code, most recent edition;</text> </paragraph> <paragraph num="(3)"> <text>International Classification of Diseases (ICD) Code, most recent edition;</text> </paragraph> <paragraph num="(4)"> <text>Medication/treatment provided; and</text> </paragraph> <paragraph num="(5)"> <text>Follow-up recommendation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The therapeutically certified optometrist shall document the following data as part of the patient's permanent file:</text> <paragraph num="(1)"> <text>Name;</text> </paragraph> <paragraph num="(2)"> <text>Date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Name of the doctor to whom the patient is referred, appointment date, and documentation that the patient or guardian preferred to schedule the referral appointment on their own;</text> </paragraph> <paragraph num="(4)"> <text>Record of tests administered and the results of the tests;</text> </paragraph> <paragraph num="(5)"> <text>Written reports of other consultations, referrals received, or both; and</text> </paragraph> <paragraph num="(6)"> <text>Documentation of the occurrence of any adverse reaction.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The therapeutically certified optometrist shall provide for 24-hour emergency coverage.</text> </paragraph> <paragraph num="G."> <text>The therapeutically certified optometrist shall have a medical kit for treating anaphylactic emergencies available at each location where patients are seen.</text> </paragraph> <paragraph num="H."> <text>The therapeutically certified optometrist shall be certified in CPR.</text> </paragraph> <paragraph num="I."> <text>The therapeutically certified optometrist shall have a written plan for responding to emergencies, including specific plans for referral to hospital emergency rooms, emergency ambulatory centers, ophthalmologists, or other appropriate medical doctors when necessary at each location where patients are seen.</text> </paragraph> <paragraph num="J."> <text>The therapeutically certified optometrist shall comply with:</text> <paragraph num="(1)"> <text>Applicable national and State standards of infection control at each office; and</text> </paragraph> <paragraph num="(2)"> <text>Principles of universal precautions as defined in COMAR 10.06.01.02B(10).</text> </paragraph> </paragraph> <paragraph num="K."> <text>The therapeutically certified optometrist shall maintain a written tracking system to identify patients who are being followed or referred for emergency sight or life-threatening conditions and who fail to keep appointments.</text> </paragraph> <paragraph num="L."> <text>The therapeutically certified optometrist shall document that a patient who fails to keep an appointment for an emergency sight or life-threatening condition was contacted by:</text> <paragraph num="(1)"> <text>Telephone;</text> </paragraph> <paragraph num="(2)"> <text>Electronic mail or other electronic means;</text> </paragraph> <paragraph num="(3)"> <text>Text message; or</text> </paragraph> <paragraph num="(4)"> <text>Mail.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The therapeutically certified optometrist shall report all adverse reactions to the Board. An adverse drug reaction may be indicated by symptoms which include, but are not limited to, painful eye, pruritus, urticarial lesions, wheals, skin rash of periorbital tissues, nausea, vomiting, fainting, confusion, cessation of respiration, wheezing, clinically significant change in heart rate, or chest pain.</text> </paragraph> <paragraph num="N."> <text>The therapeutically certified optometrist shall prescribe and administer all therapeutic pharmaceutical agents in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.</text> </paragraph> <paragraph num="O."> <text>The therapeutically certified optometrist shall remove superficial foreign bodies from the eye in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.</text> </paragraph> <paragraph num="P."> <text>A therapeutically certified optometrist may not prescribe or administer a therapeutic pharmaceutical agent unless specifically authorized by law or these regulations.</text> </paragraph> <paragraph num="Q."> <text>The therapeutically certified optometrist shall report to the Board, on the form provided by the Board, within 10 working days of the occurrence, an adverse reaction. The therapeutically certified optometrist shall include in the report, at a minimum, the following:</text> <paragraph num="(1)"> <text>The optometrist's name, address, and license number;</text> </paragraph> <paragraph num="(2)"> <text>Patient information including:</text> <paragraph num="(a)"> <text>Presenting problem;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Agent administered; and</text> </paragraph> <paragraph num="(d)"> <text>Method of administration;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The adverse reaction; and</text> </paragraph> <paragraph num="(4)"> <text>Subsequent action taken.</text> </paragraph> </paragraph> <paragraph num="R."> <text>Glaucoma Management.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §11-404.2, Annotated Code of Maryland, a therapeutically certified optometrist shall perform the procedures and tests necessary to diagnose primary open angle glaucoma appropriately.</text> </paragraph> <paragraph num="(2)"> <text>A therapeutically certified optometrist may administer and prescribe topical pharmaceutical agents for glaucoma only as authorized by law.</text> </paragraph> </paragraph> <paragraph num="S."> <text>In developing a glaucoma treatment plan that ensures the maximum effectiveness for the patient, the therapeutically certified optometrist shall consider the following:</text> <paragraph num="(1)"> <text>Types of agents to be administered and potential side effects;</text> </paragraph> <paragraph num="(2)"> <text>Status of the optic nerve structure, function, and its relationship to intraocular pressure;</text> </paragraph> <paragraph num="(3)"> <text>Identification of a target intraocular pressure at or below the target level in which further optic nerve damage is unlikely to occur;</text> </paragraph> <paragraph num="(4)"> <text>Maintenance of intraocular pressure at or below the target level by initiating appropriate therapeutic intervention;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring of the optic nerve and resetting the target intraocular pressure if deterioration occurs;</text> </paragraph> <paragraph num="(6)"> <text>Minimization of the side effects of treatment and their impact on the patient's vision, general health, and quality of life;</text> </paragraph> <paragraph num="(7)"> <text>Education of the patient in the management of primary open angle glaucoma disease;</text> </paragraph> <paragraph num="(8)"> <text>Reference to accepted clinical guidelines for glaucoma follow-up management; and</text> </paragraph> <paragraph num="(9)"> <text>Criteria for surgical intervention.</text> </paragraph> </paragraph> <paragraph num="T."> <text>Laboratory Tests. Laboratory tests shall be ordered by a therapeutically certified optometrist only as provided by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Monitoring of Complaint Investigation."> <paragraph num="A."> <text>The Board shall review complaints against optometrists relating to ocular therapeutics, management of primary open angle glaucoma, removal of superficial foreign bodies, and other aspects of practice by a therapeutically certified optometrist.</text> </paragraph> <paragraph num="B."> <text>The Board's procedures for handling complaints are governed by Health Occupations Article, Title 11, Annotated Code of Maryland, COMAR 10.28.04, and State Government Article, §§10-201—10-227, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-101, 11-205, 11-302—11-309, 11-401.1, 11-404, and 11-404.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective May 17, 1996 (23:12 Md. R. 867); adopted permanently effective October 21, 1996 (23:21 Md. R. 1467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 amended as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); amended permanently effective March 4, 2002 (29:4 Md. R. 417)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 19, 2009 (36:21 Md. R. 1591); May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .06 amended effective October 15, 2001 (28:20 Md. R. 1783)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective October 19, 2009 (36:21 Md. R. 1591)</annotation> <annotation type="History" subtype="Administrative History">Regulations .08 repealed effective October 15, 2001 (28:20 Md. R. 1783)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 15, 2021 (48:23 Md. R. 980)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 7, 2025 (52:13 Md. R. 656)</annotation> </annotations> </chapter> <chapter num="13" heading="Civil Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the standards by which the Board may:</text> <paragraph num="A."> <text>Impose an administrative monetary penalty not exceeding $5,000 on an individual licensed under Health Occupations Article, Title 11, Annotated Code of Maryland, for an act or omission prohibited under Health Occupations Article, §11-313, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>Assess a civil fine not exceeding $50,000 on a person who violates Health Occupations Article, §11–501, 11–502, or 11–504, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means an individual licensed by the Board to practice optometry.</text> </paragraph> <paragraph num="(3)"> <text>“Violation” means:</text> <paragraph num="(a)"> <text>An act or omission prohibited under Health Occupations Article, §11-313, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>An act prohibited under Heath Occupations Article, §11-501, 11-502, or 11-504, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authority to Impose an Administrative Monetary Penalty."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §11-315, Annotated Code of Maryland, and COMAR 10.28.04, the Board may impose an administrative monetary penalty of $5,000 or less on a licensee who is found to have committed a violation.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a penalty under §A of this regulation:</text> <paragraph num="(1)"> <text>For each occasion the licensee commits a violation, not to exceed a maximum of $5,000;</text> </paragraph> <paragraph num="(2)"> <text>In addition to suspension or revocation of a license; or</text> </paragraph> <paragraph num="(3)"> <text>Instead of suspension of a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Factors to be Considered in the Assessment of Penalties."> <text>In determining whether to impose a penalty and the amount of the penalty, the Board shall consider the following factors:</text> <paragraph num="A."> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="B."> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="C."> <text>The extent to which the individual derived a financial benefit from the violation;</text> </paragraph> <paragraph num="D."> <text>The history of a previous violation or violations;</text> </paragraph> <paragraph num="E."> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="F."> <text>Mitigating factors as presented by the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Payment of Penalties."> <paragraph num="A."> <text>Within 30 days of the date of the Board’s order:</text> <paragraph num="(1)"> <text>A licensee shall pay to the Board the administrative monetary penalty imposed; or</text> </paragraph> <paragraph num="(2)"> <text>A person shall pay the civil fine assessed by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall pay into the General Fund of the State all monies collected under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board, the Board may not restore, reinstate, or renew the license of the licensee until the licensee pays the penalty in full.</text> </paragraph> <paragraph num="D."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Civil Fines."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §11–315, Annotated Code of Maryland, and COMAR 10.28.04, the Board may assess a civil fine not to exceed $50,000 against a person who:</text> <paragraph num="(1)"> <text>Practices optometry without a license in violation of Health Occupations Article, §11–501, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Misrepresents to the public by title, by description of services, methods, or procedures, or otherwise that the person practices optometry in violation of Health Occupations Article, §11–502, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>Knowingly sells or dispenses contact lenses or replacement contact lenses without a valid and unexpired prescription or replacement contact lens prescription in violation of Health Occupations Article, §11–504, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether to assess a fine and the amount of the fine, the Board shall consider the following factors:</text> <paragraph num="(1)"> <text>The cost of investigating and prosecuting the case against the person;</text> </paragraph> <paragraph num="(2)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(3)"> <text>The extent to which the person derived a financial benefit from the violation;</text> </paragraph> <paragraph num="(4)"> <text>The history of a previous violation or violations;</text> </paragraph> <paragraph num="(5)"> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="(6)"> <text>Mitigating factors as presented by the person.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§11-205, 11-313 — 11-315, and 11-505, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 20, 1998 (25:8 Md. R. 597)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 17, 2015 (42:16 Md. R. 1055)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 17, 2015 (42:16 Md. R. 1055)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, C amended effective August 17, 2015 (42:16 Md. R. 1055)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective August 17, 2015 (42:16 Md. R. 1055)</annotation> </annotations> </chapter> <chapter num="14" heading="Code of Conduct"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all optometrists licensed by the State Board of Examiners in Optometry to practice in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(2)"> <text>“Inappropriate sexual language” means:</text> <paragraph num="(a)"> <text>A sexualized harassing comment;</text> </paragraph> <paragraph num="(b)"> <text>An eroticized or sexually provocative comment not reasonably associated with a health care matter; or</text> </paragraph> <paragraph num="(c)"> <text>An inappropriate discussion of a sexually related matter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Patient” means the individual to whom the licensee is rendering professional service.</text> </paragraph> <paragraph num="(4)"> <text>“Sexual behavior” means:</text> <paragraph num="(a)"> <text>A sexual act as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Sexual contact as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Sexual exploitation” means a situation in which the licensee takes advantage of the unequal relationship between the licensee and a patient, a student, or an employee to obtain sexual favors.</text> </paragraph> <paragraph num="(6)"> <text>“Sexual harassment” means a deliberate or repeated comment, advance, gesture, solicitation, request, or physical contact of a sexual nature.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Conduct."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Apprise the patient of the risks, opportunities, and obligations associated with services available to the patient;</text> </paragraph> <paragraph num="(2)"> <text>Make the fee for service clear, maintain adequate financial records, and confirm arrangements for financial reimbursement with the patient;</text> </paragraph> <paragraph num="(3)"> <text>Notify the patient promptly and seek the transfer, referral, or continuation of service in relation to the patient's need or preference if the licensee anticipates the termination or interruption of service to the patient;</text> </paragraph> <paragraph num="(4)"> <text>Obtain voluntary and informed consent from a patient for participation in research, without direct or implied deprivation or penalty for refusal to participate;</text> </paragraph> <paragraph num="(5)"> <text>Inform the Board of unethical conduct by a licensed optometrist; and</text> </paragraph> <paragraph num="(6)"> <text>Inform the Board about an individual who is not licensed by the Board but who represents that the individual is an optometrist and is practicing, attempting to practice, or offering to practice optometry.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the capacity of or identity as a licensed optometrist, the licensee may not:</text> <paragraph num="(1)"> <text>Participate or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Misrepresent professional qualifications, education, experience, or affiliation;</text> </paragraph> <paragraph num="(3)"> <text>Exploit a relationship with a patient for personal advantage or satisfaction;</text> </paragraph> <paragraph num="(4)"> <text>Practice, condone, facilitate, or collaborate with discrimination on the basis of race, color, sex, sexual orientation, age, religion, national origin, marital status, political belief, mental or physical handicap, or other preference or personal characteristic, condition, or status;</text> </paragraph> <paragraph num="(5)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a patient; or</text> </paragraph> <paragraph num="(6)"> <text>Share a fee or accept or give something of value for receiving or making a referral.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sexual Misconduct."> <paragraph num="A."> <text>An optometrist may not engage in sexual misconduct in the practice of optometry.</text> </paragraph> <paragraph num="B."> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client or patient in the context of a professional evaluation, treatment, procedure, or service to the client or patient, regardless of the setting in which the professional service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client or patient under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Requesting sexual favors of a client or patient;</text> </paragraph> <paragraph num="(4)"> <text>Inappropriate touching of a client or patient in a sexual manner;</text> </paragraph> <paragraph num="(5)"> <text>Therapeutically unnecessary discussion of sexual matters or other verbal conduct of a sexual nature while treating a patient;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs or video tapes of a client or patient for sexual purposes;</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of staff or students;</text> </paragraph> <paragraph num="(8)"> <text>Sexual exploitation; or</text> </paragraph> <paragraph num="(9)"> <text>Inappropriate sexual language.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Concurrent Sexual Relationships. The licensee may not engage in either consensual or forced sexual behavior with:</text> <paragraph num="(1)"> <text>A patient;</text> </paragraph> <paragraph num="(2)"> <text>A student or supervisor over whom the licensee exercises professional authority or with whom the licensee maintains direct supervision or education while the professional relationship continues to exist; or</text> </paragraph> <paragraph num="(3)"> <text>An individual with whom the patient has a close personal relationship, including but not limited to a relative or a significant individual in the patient's life, if there is a risk of exploitation or potential harm to the patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Relationships with Former Patients.</text> <paragraph num="(1)"> <text>Except as set forth in §D(3) of this regulation, the licensee may not engage in sexual behavior with a former patient.</text> </paragraph> <paragraph num="(2)"> <text>The licensee may not terminate professional services or a professional relationship with a patient in order to enter into a nonprofessional, social, or sexual relationship with the patient or an individual with whom the patient has a close personal relationship.</text> </paragraph> <paragraph num="(3)"> <text>The licensee may enter into a relationship with an individual with whom the licensee's prior professional contact was of a brief, peripheral, consultative, or indirect nature, and did not constitute a therapeutic relationship.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Prior Sexual Relationships. The licensee may not provide professional services to an individual with whom the licensee has previously engaged in sexual behavior.</text> </paragraph> <paragraph num="F."> <text>Sexual Harassment.</text> <paragraph num="(1)"> <text>The licensee may not sexually harass a:</text> <paragraph num="(a)"> <text>Patient;</text> </paragraph> <paragraph num="(b)"> <text>Student; or</text> </paragraph> <paragraph num="(c)"> <text>Employee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If sexually harassed by a patient, the licensee shall:</text> <paragraph num="(a)"> <text>Seek professional consultation with another licensed health professional;</text> </paragraph> <paragraph num="(b)"> <text>Document all action taken in the patient's record; and</text> </paragraph> <paragraph num="(c)"> <text>Terminate treatment and assist in a referral to another health care provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Deceit During Evaluation, Treatment, Procedure, or Service. The licensee may not suggest, recommend, or encourage the patient to engage in a sexually provocative act, including but not limited to:</text> <paragraph num="(1)"> <text>Sexual contact with the licensee;</text> </paragraph> <paragraph num="(2)"> <text>Genital stimulation by or of the patient or licensee;</text> </paragraph> <paragraph num="(3)"> <text>Undressing by or of the licensee in the presence of the patient, or of the patient in the presence of the licensee; and</text> </paragraph> <paragraph num="(4)"> <text>Discussion or disclosure of a sexually provocative or erotic nature, not necessitated by treatment or treatment protocol.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties."> <text>Violation of this chapter may result in the Board taking action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $5,000.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 11-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 31, 2006 (33:15 Md. R. 1281)</annotation> </annotations> </chapter> <chapter num="15" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter permits the Board to disclose investigative information to other agencies or other entities, or both, under certain circumstances.</text> </paragraph> <paragraph num="B."> <text>A custodian may disclose information in a certification, licensing, or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>The custodian may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §§11-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 2002 (28:26 Md. R. 2273)</annotation> </annotations> </chapter> <chapter num="16" heading="Selling and Dispensing of Contact Lenses"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Contact lens” means a medical device of any material or power, including plano or zero-powered, that is placed directly on:</text> <paragraph num="(a)"> <text>The cornea; or</text> </paragraph> <paragraph num="(b)"> <text>The cornea and sclera.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Contact lens prescription” means “replacement contact lens prescription” as defined in Health Occupations Article, §11-404.4, Annotated Code of Maryland, and any federal statute and regulations that may supersede this Health Occupations citation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Sales and Dispensing of Contact Lenses."> <text>Contact lens prescriptions and contact lenses are prescribed, sold, dispensed, and otherwise regulated as stated in Health Occupations Article, §11-404.4, Annotated Code of Maryland, and any federal statute and regulations that may supersede this Health Occupations citation.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §24-301.1;Health Occupations Article, §§11-101, 11-205, and 11-404.4; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 2006 (33:1 Md. R. 36)</annotation> </annotations> </chapter> <chapter num="17" heading="Disciplinary Sanctions and Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for sanctions and monetary penalties not exceeding $5,000 against any optometrist in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §11-314, Annotated Code of Maryland, to impose a sanction or monetary penalty.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Examiners in Optometry.</text> </paragraph> <paragraph num="(2)"> <text>“License” means a license issued by the Board to practice optometry.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means an optometrist who is licensed by the Board to practice optometry.</text> </paragraph> <paragraph num="(4)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(5)"> <text>“Sanction” means a formal disciplinary action against a license such as a reprimand, probation, suspension, or revocation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty — General."> <text>Imposition of a Penalty After a Hearing. If, after a hearing under Health Occupations Article, §11-315, Annotated Code of Maryland, the Board finds that there are grounds under Health Occupations Article, §11-313, Annotated Code of Maryland, to suspend or revoke a license, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="A."> <text>Instead of, or in addition to, suspending the license; or</text> </paragraph> <paragraph num="B."> <text>In addition to revoking the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions and Imposition of Penalties."> <paragraph num="A."> <text>Subject to the provisions of this section, the Board may impose sanctions and penalties for violations of the Maryland Optometry Act and its regulations according to the guidelines set forth in the following chart:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this chapter, the category or categories containing the highest maximum sanction and penalty shall prevail.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or a consent order with terms, sanction, and penalty agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="D."> <text>A departure from the guidelines set forth in this chapter alone is not grounds for any hearing or appeal of a Board action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction."> <text>Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="A."> <text>Mitigating Factors:</text> <paragraph num="(1)"> <text>The licensee’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The licensee self-reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The licensee’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>Timely good-faith effort to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm or adverse impact to the public; and</text> </paragraph> <paragraph num="(9)"> <text>The licensee’s conduct was an isolated incident and not likely to recur.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating Factors:</text> <paragraph num="(1)"> <text>The licensee has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the client or clients;</text> </paragraph> <paragraph num="(7)"> <text>The licensee lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(8)"> <text>The licensee committed the violation under the guise of treatment; and</text> </paragraph> <paragraph num="(9)"> <text>Previous attempts at rehabilitation of the licensee were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="D."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of Penalty."> <paragraph num="A."> <text>A licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §11-318, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter into the State's General Fund.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606 and 11-314, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 1, 2012 (39:19 Md. R. 1237)</annotation> </annotations> </chapter> </subtitle> <subtitle num="29" heading="Board of Morticians and Funeral Directors"> <chapter num="01" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs procedures for disciplinary matters and hearings before the Maryland State Board of Morticians and Funeral Directors and establishes the standards for use as a guide for the imposition of disciplinary sanctions against any of the following under jurisdiction of the Board:</text> <paragraph num="(1)"> <text>A licensed mortician, funeral director, apprentice, surviving spouse, funeral establishment, corporation, crematory supervisor, or executor;</text> </paragraph> <paragraph num="(2)"> <text>A courtesy card holder;</text> </paragraph> <paragraph num="(3)"> <text>A holder of a permit to operate a crematory;</text> </paragraph> <paragraph num="(4)"> <text>A certified crematory operator or crematory technician;</text> </paragraph> <paragraph num="(5)"> <text>A holder of a mortuary transport permit; and</text> </paragraph> <paragraph num="(6)"> <text>A registered transporter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If, after a hearing, the Board finds that there are grounds under Health Occupations Article, §7–316 or 7–604, Annotated Code of Maryland, to sanction any person listed in §A of this regulation by way of probation, reprimand, suspension, fine, or revocation, the Board may consider aggravating and mitigating factors in determining sanctions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>All interested parties shall be afforded an opportunity to be present at formal hearings.</text> </paragraph> <paragraph num="B."> <text>Written notice of the hearing shall be sent by the Secretary of the Board to all interested parties at least 30 days before the hearing. The notice shall state the date, time and place of the hearing. It shall also state the issues or charges involved in the proceeding. However, if by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issue is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Parties and Representation."> <paragraph num="A."> <text>“Party” includes any person or agency named or admitted as a party, or properly seeking and entitled as of right to be admitted as a party, in formal hearings. Any person or agency may be admitted as a party for limited purposes.</text> </paragraph> <paragraph num="B."> <text>All parties appearing at formal hearings shall have the right to appear in proper person or by or with counsel. All parties shall have the right to be accompanied, represented and advised by counsel.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Procedures."> <paragraph num="A."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §B of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="E."> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(1)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="G."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation shall apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board. The record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceeding, or part thereof, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Presiding Officer Duties."> <text>Each hearing shall be held before a quorum of the Board. The president, or in his absence a member designated by him, shall be the presiding officer, and shall have complete charge of the hearing, permit the examination of witnesses, admit evidence, rule on the admissibility of evidence, and adjourn or recess the hearing from time to time.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Order of Procedure."> <text>The order in which the parties shall present their case shall be determined by the presiding officer.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Examination of Witness and Introduction of Evidence."> <paragraph num="A."> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions and motions. However, when a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions and motions shall be done and presented solely by the counsel.</text> </paragraph> <paragraph num="C."> <text>The presiding officer, or any person designated by him for the purpose, may examine any witness called by any party. He may call as a witness any person in attendance at the hearing. Any member of the Board may examine any witness called by any party.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Briefs."> <text>Any party may submit briefs of the issues of fact and law involved in the hearing. The briefs shall be filed in the form, with the number of copies, and at the time as the presiding officer may designate.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>General Application.</text> <paragraph num="(1)"> <text>This regulation shall be used by the Board as a guide for sanctioning pursuant to the Board’s authority under Health Occupations Article, §§7–205, 7–316, and 7–604, Annotated Code of Maryland, for violations of the Morticians and Funeral Directors Act and the Board’s regulations.</text> </paragraph> <paragraph num="(2)"> <text>The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines.</text> </paragraph> <paragraph num="(3)"> <text>A departure from the sanctioning guidelines alone is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="(4)"> <text>Notwithstanding these sanctioning guidelines, in order to resolve a disciplinary matter, the Board and the offending person may agree to surrender a license, courtesy card, permit, or certificate, or agree to a consent order with terms, conditions, and sanctions agreed upon.</text> </paragraph> <paragraph num="(5)"> <text>In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation.</text> </paragraph> <paragraph num="(6)"> <text>If probation is imposed, the Board may impose appropriate terms and conditions of probation. Violations of the terms or conditions may cause the Board to take further disciplinary action.</text> </paragraph> <paragraph num="(7)"> <text>In the event a violation does not fall within the sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and consider, to the extent possible, the factors in the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> <paragraph num="C."> <text>Mitigating and Aggravating Factors. Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside of the range of sanctions established by the guidelines. These factors may include, but are not limited to the following:</text> <paragraph num="(1)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The respondent reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The respondent voluntarily admitted violation, provided full disclosure to the Board, and cooperated during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The respondent implemented remedial measures to correct or mitigate harm arising from the violation;</text> </paragraph> <paragraph num="(e)"> <text>The respondent made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of rehabilitation or potential for rehabilitation;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the violation;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to or adverse impact on the public or adverse impact on the public;</text> </paragraph> <paragraph num="(i)"> <text>Isolated incident and not likely to recur; and</text> </paragraph> <paragraph num="(j)"> <text>The respondent’s prior community service and present value to the community.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The respondent was motivated to perform the violation by the respondent’s financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the bereaved;</text> </paragraph> <paragraph num="(g)"> <text>The respondent attempted to conceal the violation, falsified or destroyed evidence, or presented false testimony or evidence;</text> </paragraph> <paragraph num="(h)"> <text>The respondent failed to cooperate with the Board’s investigation; and</text> </paragraph> <paragraph num="(i)"> <text>Previous attempts at rehabilitation were unsuccessful.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Counsel to the Board."> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing as counsel for the Board. Upon that request, the counsel shall have all of the rights with regard to the submission of evidence, examination and cross-examination.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Decision and Order."> <text>Every decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law. The findings of fact shall consist of a concise statement of the conclusions upon each contested issue of fact. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or his attorney of record.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Rehearings."> <paragraph num="A."> <text>Any party aggrieved by the decision and order rendered in the particular case may apply for rehearing within 10 days after service on him of the decision and order. Action on the application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for rehearing shall stay the enforcement of the order or excuse the persons affected by it for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may, on rehearing, consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 7-205(a)(1) and (c), 7-316, 7-318, and 7-604, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 14, 1968</annotation> <annotation type="History" subtype="Administrative History">Preface amended effective December 15, 1986 (13:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 recodified to .01-1 and the Preface recodified to Regulation .01, July 1991</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 5, 2001 (28:4 Md. R. 418)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 24, 2016 (43:21 Md. R. 1167)</annotation> </annotations> </chapter> <chapter num="02" heading="Examination"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means any individual who qualifies to take the Maryland mortician or funeral director examination.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(3)"> <text>“Maryland mortician and funeral director examination” means the legal and practical examination that is given by the Board to test the competency of individuals applying for a Maryland mortician or funeral director license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope of Examination."> <text>The Board will give a two-part examination which consists of a:</text> <paragraph num="A."> <text>Legal part, testing the applicant's knowledge of Maryland law and regulations governing mortuary science, including subject areas disclosed to applicants as part of a notification of the upcoming examination sent to all licensed apprentices and other applicants; and</text> </paragraph> <paragraph num="B."> <text>One of the following:</text> <paragraph num="(1)"> <text>Practical part for morticians, testing competency in embalming and otherwise preserving a dead human body, as specified in Health Occupations Article, §7-304(d)(1)(i) and (ii), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Practical part for funeral directors, testing competency in hazardous waste and washing and handling a dead human body.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Examination."> <text>An applicant shall:</text> <paragraph num="A."> <text>Hold an apprentice license or have completed the apprenticeship requirements;</text> </paragraph> <paragraph num="B."> <text>Submit an application for examination on the required form; and</text> </paragraph> <paragraph num="C."> <text>Pay to the Board the examination fee set forth under COMAR 10.29.04.02A.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Passing Score."> <paragraph num="A."> <text>A minimum passing grade of 75 percent is required on the:</text> <paragraph num="(1)"> <text>Law examination;</text> </paragraph> <paragraph num="(2)"> <text>Practical examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails either part of the examination may retake that part of the examination one time during the next examination period without paying an additional $100 fee.</text> </paragraph> <paragraph num="C."> <text>An applicant who fails both parts of the examination may retake the entire examination one time during the next examination period without paying an additional $100 fee.</text> </paragraph> <paragraph num="D."> <text>The Board shall notify each applicant by mail of the results of the examination within 45 days after it is taken. Numerical scores may not be given out unless requested in writing by the applicant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Frequency of Examination."> <text>The Board shall hold an examination twice a year, in April and October.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="National Examination."> <paragraph num="A."> <text>Before granting a Maryland mortician or funeral director license, the Board shall require an applicant to take and pass the national examination administered by the Conference of Funeral Service Examining Boards of the United States. The national examination may be taken either before or after the applicant takes the Maryland examination. An applicant may retake the national examination as often as is necessary to fulfill this requirement.</text> </paragraph> <paragraph num="B."> <text>A minimum passing grade of 75 percent on each section of the examination is required.</text> </paragraph> <paragraph num="C."> <text>The two sections of the examination are:</text> <paragraph num="(1)"> <text>Funeral service science, which includes:</text> <paragraph num="(a)"> <text>Embalming;</text> </paragraph> <paragraph num="(b)"> <text>Restorative art;</text> </paragraph> <paragraph num="(c)"> <text>Microbiology;</text> </paragraph> <paragraph num="(d)"> <text>Pathology;</text> </paragraph> <paragraph num="(e)"> <text>Chemistry; and</text> </paragraph> <paragraph num="(f)"> <text>Anatomy;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Funeral service arts, which includes:</text> <paragraph num="(a)"> <text>Sociology of funeral service;</text> </paragraph> <paragraph num="(b)"> <text>Psychology and counseling;</text> </paragraph> <paragraph num="(c)"> <text>Funeral directing and professional relationships;</text> </paragraph> <paragraph num="(d)"> <text>Business law;</text> </paragraph> <paragraph num="(e)"> <text>Funeral service law;</text> </paragraph> <paragraph num="(f)"> <text>Funeral merchandising; and</text> </paragraph> <paragraph num="(g)"> <text>Accounting.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §7-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 4, 1987 (14:9 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective January 8, 2024 (50:26 Md. R. 1131)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> </annotations> </chapter> <chapter num="03" heading="Inspection of Funeral Establishments"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The purpose and intent of this chapter is to prescribe minimum standards for new and existing funeral establishments, renovations of existing funeral establishments, restricted funeral establishments, and change of ownership of funeral establishments where the practice of mortuary science or funeral direction is conducted.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Deficiency” means a specific failure to comply with the requirements set forth by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Funeral director” means an individual who is licensed by the Board to practice all aspects of mortuary science, except for embalming.</text> </paragraph> <paragraph num="(4)"> <text>“Funeral establishment” means any building, structure, or premises licensed by the Board, with facilities for:</text> <paragraph num="(a)"> <text>Embalming or holding of human remains for disposition;</text> </paragraph> <paragraph num="(b)"> <text>Viewing of the human remains; and</text> </paragraph> <paragraph num="(c)"> <text>Funeral services.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Funeral establishment sponsor” means any licensed funeral establishment providing for the operation of a Board-approved restricted funeral establishment.</text> </paragraph> <paragraph num="(6)"> <text>“Holding room” means a room which is:</text> <paragraph num="(a)"> <text>Used for the holding of human remains if arterial embalming is not a function of the funeral establishment; and</text> </paragraph> <paragraph num="(b)"> <text>Distinct from the viewing room, chapel, or any other part of a funeral establishment.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Inspection” means a survey of a funeral establishment by an inspector designated by the Board to ensure compliance with this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Mortician” means an individual who is licensed by the Board to practice mortuary science.</text> </paragraph> <paragraph num="(9)"> <text>“Ownership” means having or controlling directly or indirectly at least 10 percent interest in the corporation, partnership, association, organization, or other business entity.</text> </paragraph> <paragraph num="(10)"> <text>Practice Funeral Direction.</text> <paragraph num="(a)"> <text>“Practice funeral direction” means to:</text> <paragraph num="(i)"> <text>Operate a funeral establishment;</text> </paragraph> <paragraph num="(ii)"> <text>For compensation, prepare human remains for disposition; and</text> </paragraph> <paragraph num="(iii)"> <text>For compensation, arrange for or make final disposition of human remains.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice funeral direction” does not include:</text> <paragraph num="(i)"> <text>For compensation, disinfecting or preserving human remains or any of its parts by arterial or cavity injection or any other type of preservation; or</text> </paragraph> <paragraph num="(ii)"> <text>The business of operating a crematory.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>Practice Mortuary Science.</text> <paragraph num="(a)"> <text>“Practice mortuary science” means:</text> <paragraph num="(i)"> <text>The practice of funeral direction; and</text> </paragraph> <paragraph num="(ii)"> <text>Disinfecting or preserving human remains or any of its parts by arterial or cavity injection.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice mortuary science” does not include:</text> <paragraph num="(i)"> <text>The pickup, removal, or transportation of human remains, if the unlicensed individual is acting under the direction of a licensed mortician or funeral director; or</text> </paragraph> <paragraph num="(ii)"> <text>The business of operating a crematory.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Preneed contract” means an agreement between a consumer and a licensed funeral director or licensed mortician to provide any goods and services purchased before the time of death.</text> </paragraph> <paragraph num="(13)"> <text>“Preparation room” means an area with a minimum of 120 square feet which is used exclusively for the practice of mortuary science, which is separate and distinct from the viewing room, chapel, or any other part of a funeral establishment.</text> </paragraph> <paragraph num="(14)"> <text>“Restricted funeral establishment” means a licensed business authorized by the Board under Health Occupations Article, §7-310(a)(2), Annotated Code of Maryland, to practice mortuary science or funeral direction services by a licensed mortician or funeral director with a designated sponsoring funeral establishment.</text> </paragraph> <paragraph num="(15)"> <text>“Supervising funeral director” means a funeral director who is responsible to the Board for compliance with Health Occupations Article, Title 7, Annotated Code of Maryland, for all operations of a funeral establishment including, but not limited to, the administration of preneed accounts.</text> </paragraph> <paragraph num="(16)"> <text>“Supervising mortician” means a mortician who is responsible to the Board for compliance with Health Occupations Article, Title 7, Annotated Code of Maryland, for all operations of a funeral establishment including, but not limited to, the administration of preneed accounts.</text> </paragraph> <paragraph num="(17)"> <text>“Viewing room” means an area in which human remains are placed on display and which is a separate and distinct area from the preparation and holding room.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Funeral Establishment Requirements."> <paragraph num="A."> <text>The Board shall license a funeral establishment before the funeral establishment may be used for the practice of mortuary science or funeral direction.</text> </paragraph> <paragraph num="B."> <text>The Board shall issue a funeral establishment license to a funeral establishment that has:</text> <paragraph num="(1)"> <text>Complied with all applicable federal, State, and local laws, including the requirements set forth in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C of this regulation, completed all requirements specified in this chapter within 6 months of application submission;</text> </paragraph> <paragraph num="(3)"> <text>Submitted an application to the Board on the required form at least 60 days before the opening of the business;</text> </paragraph> <paragraph num="(4)"> <text>Paid the non-refundable application fee and, when applicable, the family security trust fund fee; and</text> </paragraph> <paragraph num="(5)"> <text>Operated in accordance with Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application Extension Request. To obtain approval from the Board for an application extension, a funeral establishment shall:</text> <paragraph num="(1)"> <text>Submit, in writing to the Board, a one-time application extension request not to exceed 90 days; and</text> </paragraph> <paragraph num="(2)"> <text>Explain the reason for the extension request.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A license shall expire on the date set by the Board, unless the license is renewed for an additional term at a fee set by the Board.</text> </paragraph> <paragraph num="E."> <text>A license is nontransferable and may not be renewed for a term longer than 2 years.</text> </paragraph> <paragraph num="F."> <text>Upon a sale or change in ownership of the funeral establishment, the new owner shall:</text> <paragraph num="(1)"> <text>Notify the Board within 14 days; and</text> </paragraph> <paragraph num="(2)"> <text>Request a new license by submitting an application to the Board in writing with supporting documentation reflecting the sale or change of ownership.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Board shall issue a new funeral establishment license reflecting the sale or change in ownership if:</text> <paragraph num="(1)"> <text>The applicant submits the required documentation to the Board; and</text> </paragraph> <paragraph num="(2)"> <text>An inspection of the funeral establishment results in a finding that the funeral establishment is in compliance with all applicable federal, State, and local laws.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A license, and the licenses of individual licensees employed at the funeral establishment, shall be displayed prominently at the premises.</text> </paragraph> <paragraph num="I."> <text>The funeral establishment:</text> <paragraph num="(1)"> <text>Shall employ and designate, on a form provided by the Board, a supervising mortician or supervising funeral director, licensed in accordance with State laws, who shall be in compliance with Health Occupations Article, Title 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Shall prominently display on a sign, not smaller than 8 and 1/2 inches by 11 inches, immediately located either outside or inside the main entrance, in letters not less than one-half inch high, the names of:</text> <paragraph num="(a)"> <text>Each licensee who holds at least a 10 percent ownership interest in the partnership, professional association, or sole proprietorship which operates the funeral establishment;</text> </paragraph> <paragraph num="(b)"> <text>Any individual, corporation, or other business entity, which either directly or indirectly holds an ownership interest of 10 percent or more in the corporation or business entity that operates the funeral establishment; and</text> </paragraph> <paragraph num="(c)"> <text>All restricted funeral establishments operating from that funeral establishment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>That does embalmings and has designated a funeral director as the supervising agent shall employ a licensed mortician on staff;</text> </paragraph> <paragraph num="(4)"> <text>May not be required to apply for a new funeral establishment license if there is a change of a supervising mortician or supervising funeral director;</text> </paragraph> <paragraph num="(5)"> <text>Shall notify the Board, on a form provided by the Board, of any change of supervising mortician or supervising funeral director within 10 days;</text> </paragraph> <paragraph num="(6)"> <text>May not operate without a supervising mortician or supervising funeral director, who shall be continuously responsible, for more than 30 calendar days; and</text> </paragraph> <paragraph num="(7)"> <text>Shall ensure that medical waste is picked up by a licensed medical waste disposer not less than every 60 days from the date generated as outlined in COMAR 10.06.06.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Restricted Funeral Establishment Requirements."> <paragraph num="A."> <text>The Board shall license a restricted funeral establishment before the restricted funeral establishment may be used for the practice of mortuary science or funeral direction.</text> </paragraph> <paragraph num="B."> <text>The Board shall issue a restricted funeral establishment license to a restricted funeral establishment that has:</text> <paragraph num="(1)"> <text>Complied with:</text> <paragraph num="(a)"> <text>All applicable federal, State, and local laws;</text> </paragraph> <paragraph num="(b)"> <text>Advertising requirements set forth in COMAR 10.29.12; and</text> </paragraph> <paragraph num="(c)"> <text>Regulation .05 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For each restricted funeral establishment:</text> <paragraph num="(a)"> <text>Submitted an application to the Board on the required form which includes a full description of services;</text> </paragraph> <paragraph num="(b)"> <text>Paid the application fee and, when applicable, the family security trust fund fee; and</text> </paragraph> <paragraph num="(c)"> <text>Completed and passed an inspection as outlined in Regulation .05 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>After July 1, 2001, submitted to the Board copies of the documents listed in Regulation .05D of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Beginning January 1, 2002, submitted during the bi-annual inspection to the Board, copies of the documents listed in Regulation .05D of this chapter created during the preceding year; and</text> </paragraph> <paragraph num="(5)"> <text>Operated in accordance with Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The restricted funeral establishment shall:</text> <paragraph num="(1)"> <text>Submit a notarized lease agreement with the sponsoring funeral establishment, including an application stating scope of operations for approval to the Board;</text> </paragraph> <paragraph num="(2)"> <text>Employ and designate, on a form provided by the Board, a supervising mortician or supervising funeral director, licensed in accordance with State laws, who shall be in compliance with Health Occupations Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Submit documentation of any termination or change in the status of the lease agreement, within 10 days of the termination or change in status.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subject to the hearing provisions of Health Occupations Article, §7-319, Annotated Code of Maryland, the Board may:</text> <paragraph num="(1)"> <text>Deny a license to an applicant for a restricted funeral establishment license;</text> </paragraph> <paragraph num="(2)"> <text>Reprimand the holder of a restricted funeral establishment license;</text> </paragraph> <paragraph num="(3)"> <text>Place the holder of a restricted funeral establishment license on probation:</text> </paragraph> <paragraph num="(4)"> <text>Suspend or revoke a restricted funeral establishment license if, with the knowledge or at the direction of the restricted funeral establishment:</text> <paragraph num="(a)"> <text>An unlicensed individual practices mortuary science or funeral direction for or within the restricted funeral establishment; or</text> </paragraph> <paragraph num="(b)"> <text>An employee of the restricted funeral establishment fails to comply with:</text> <paragraph num="(i)"> <text>Health-General Article, §5-513(b) and (d), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §7-405, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The funeral establishment sponsor shall remain in good standing with the Board to continue as a sponsor for any restricted funeral establishment.</text> </paragraph> <paragraph num="F."> <text>For a funeral establishment sponsor that experiences the death of single owner and sole licensee as set forth in Health Occupations Article, §7-308.3, Annotated Code of Maryland, the restricted funeral establishment:</text> <paragraph num="(1)"> <text>Shall submit to the Board a new notarized lease agreement within 30 days, if the restricted funeral establishment intends to continue operating from that sponsoring funeral establishment;</text> </paragraph> <paragraph num="(2)"> <text>Shall be subject to hearing provisions set forth under Health Occupations Article, §7-319, Annotated Code of Maryland, for failure to comply with §F(1) of this regulation, which may result in:</text> <paragraph num="(a)"> <text>A reprimand for the holder of the restricted establishment license;</text> </paragraph> <paragraph num="(b)"> <text>Probation for the holder of the restricted establishment license; or</text> </paragraph> <paragraph num="(c)"> <text>The suspension or revocation of the restricted establishment license; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>May voluntarily surrender the restricted funeral establishment license to avoid the hearing procedures provided the conditions are met as set forth under Health Occupations Article, §7-318, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If a funeral establishment sponsor closes its operations to the public, any restricted establishment license with a lease agreement with this designated funeral establishment sponsor:</text> <paragraph num="(1)"> <text>Shall become invalid upon closure of the sponsoring funeral establishment subject to the hearing provisions set forth under Health Occupations Article, §7-319, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>May voluntarily surrender the restricted funeral establishment license to avoid the hearing procedures, provided the conditions are met as set forth under Health Occupations Article, §7-318, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="H."> <text>For each location operated by the restricted funeral establishment, a separate license shall be obtained and displayed prior to commencing the practice of mortuary science or funeral direction.</text> </paragraph> <paragraph num="I."> <text>As set forth under Health Occupations Article, §7-504, preneed services and merchandise may be offered by a restricted funeral establishment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspection by the Board."> <paragraph num="A."> <text>A licensed funeral establishment and a restricted funeral establishment shall be open at all reasonable times for inspection by the Board. Inspection results shall be written on forms approved by the Board.</text> </paragraph> <paragraph num="B."> <text>Each funeral establishment and restricted funeral establishment shall be inspected:</text> <paragraph num="(1)"> <text>On a biennial basis;</text> </paragraph> <paragraph num="(2)"> <text>In furtherance of an investigation; or</text> </paragraph> <paragraph num="(3)"> <text>Upon the sale or change of ownership of the funeral establishment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An owner, supervising mortician, supervising funeral director, or licensed designee shall be available to accompany the inspector during the inspection and sign the inspection report.</text> </paragraph> <paragraph num="D."> <text>The following forms shall be available for inspection, with a copy given to the inspector for the inspector's records:</text> <paragraph num="(1)"> <text>A general price list of charges for services to the public;</text> </paragraph> <paragraph num="(2)"> <text>A completed and duly signed funeral service contract with any invoices attached;</text> </paragraph> <paragraph num="(3)"> <text>A price list of caskets as charged to the public;</text> </paragraph> <paragraph num="(4)"> <text>A price list of outer burial containers, as charged to the public;</text> </paragraph> <paragraph num="(5)"> <text>Cremation forms:</text> <paragraph num="(a)"> <text>Authorization form to cremate;</text> </paragraph> <paragraph num="(b)"> <text>Cremation identification form; and</text> </paragraph> <paragraph num="(c)"> <text>Disposition of cremated remains notification;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A preneed contract form along with a bank statement form, for verification of an escrow or trust account, and, if provided, an insurance statement;</text> </paragraph> <paragraph num="(7)"> <text>A copy of the hazardous waste certification form described in §E(6)(d) of this regulation; and</text> </paragraph> <paragraph num="(8)"> <text>An authorization to release the body to the funeral establishment or the restricted funeral establishment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Standards for Inspection of Funeral Establishments and Restricted Funeral Establishments.</text> <paragraph num="(1)"> <text>Preparation Room. If arterial or cavity injection will take place at a funeral establishment or a restricted funeral establishment, the funeral establishment or the restricted funeral establishment shall maintain on the premises a preparation room which shall be adequately equipped and maintained in a sanitary manner for the preservation and care of human remains. The minimal requirements shall be as follows:</text> <paragraph num="(a)"> <text>The floors, walls, and ceilings shall be smooth and made of tile or other high gloss, impervious, washable material;</text> </paragraph> <paragraph num="(b)"> <text>The floors, walls, and ceilings shall be in a clean and sanitary condition;</text> </paragraph> <paragraph num="(c)"> <text>The lighting shall be adequate;</text> </paragraph> <paragraph num="(d)"> <text>The ventilation shall be in accordance with current Occupational Safety and Health Administration (OSHA) regulations;</text> </paragraph> <paragraph num="(e)"> <text>Doors to the preparation room shall be tight-closing and the windows maintained to obstruct any view into the preparation room;</text> </paragraph> <paragraph num="(f)"> <text>The preparation room shall be a minimum of 120 square feet; and</text> </paragraph> <paragraph num="(g)"> <text>If a refrigeration unit is on the premises, it shall be clean, sanitary, and in good working condition.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Holding Room. If arterial or cavity injection will not take place at a funeral establishment or a restricted funeral establishment, the funeral establishment or the restricted funeral establishment shall maintain on the premises a holding room which shall be adequately equipped for the holding of human remains which shall be kept in a clean and sanitary manner. The minimal requirements for the holding room shall be as follows:</text> <paragraph num="(a)"> <text>The floors, walls, and ceilings shall be smooth and made of tile or other high gloss, impervious, washable material;</text> </paragraph> <paragraph num="(b)"> <text>The floors, walls, and ceilings shall be in a clean and sanitary condition;</text> </paragraph> <paragraph num="(c)"> <text>The lighting shall be adequate;</text> </paragraph> <paragraph num="(d)"> <text>An exhaust system whereby gases would be drawn to outside air shall be the minimum standard for holding rooms in funeral establishments where embalming does not take place;</text> </paragraph> <paragraph num="(e)"> <text>Doors to the holding room shall be tight-closing and the windows maintained to obstruct any view into the holding room; and</text> </paragraph> <paragraph num="(f)"> <text>The holding room shall be a minimum of 120 square feet.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Instruments and Equipment.</text> <paragraph num="(a)"> <text>Instruments shall be autoclaved, steamed, or cleaned with a chemical disinfectant commonly used in the industry.</text> </paragraph> <paragraph num="(b)"> <text>The preparation table shall have a nonporous surface.</text> </paragraph> <paragraph num="(c)"> <text>The removal stretcher and litter shall have a waterproof pouch.</text> </paragraph> <paragraph num="(d)"> <text>If a refrigeration unit is on the premises, it shall be clean, sanitary, and in good working condition.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Water Supply.</text> <paragraph num="(a)"> <text>Each funeral establishment and restricted funeral establishment shall have hot and cold running water.</text> </paragraph> <paragraph num="(b)"> <text>The drain pipe for the water supply shall be at least 2 inches in diameter.</text> </paragraph> <paragraph num="(c)"> <text>Floor drainage is required in the preparation room of a funeral establishment where embalming takes place, except for an establishment that existed on or before November 26, 2001 that has not had after that date:</text> <paragraph num="(i)"> <text>The preparation room renovated; or</text> </paragraph> <paragraph num="(ii)"> <text>A change of ownership.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Chemicals. All chemicals shall be plainly marked with appropriate warning labels.</text> </paragraph> <paragraph num="(6)"> <text>Waste.</text> <paragraph num="(a)"> <text>The preparation room shall be equipped with covered waste receptacles.</text> </paragraph> <paragraph num="(b)"> <text>Infectious waste shall be clearly identified and separate from other waste and put in a rigid container.</text> </paragraph> <paragraph num="(c)"> <text>Blood and waste shall be disposed of in accordance with COMAR 10.06.06.01—.08.</text> </paragraph> <paragraph num="(d)"> <text>A copy of the hazardous waste certification form provided by the licensee's hazardous waste contractor shall be provided to the Board's inspector.</text> </paragraph> <paragraph num="(e)"> <text>The removal vehicle shall contain a universal precaution kit which shall contain at least:</text> <paragraph num="(i)"> <text>Disposable gloves;</text> </paragraph> <paragraph num="(ii)"> <text>Antibacterial hand wipes; and</text> </paragraph> <paragraph num="(iii)"> <text>A hazardous waste container for the proper disposal of wastes.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Removal Vehicle. The removal vehicle shall be suitable for the transportation of human remains obscured from public view and maintained in a sanitary manner.</text> </paragraph> <paragraph num="(8)"> <text>Funeral Service Establishment and Restricted Funeral Establishment Premises.</text> <paragraph num="(a)"> <text>The remaining areas of the funeral establishment and the restricted funeral establishment shall be in good repair, clean, and safe.</text> </paragraph> <paragraph num="(b)"> <text>If a funeral establishment or a restricted funeral establishment has a memorial gathering area, it shall be:</text> <paragraph num="(i)"> <text>In good repair;</text> </paragraph> <paragraph num="(ii)"> <text>Clean; and</text> </paragraph> <paragraph num="(iii)"> <text>At least 300 square feet in area.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If a funeral establishment or a restricted funeral establishment displays any form of casket selection, the prices shall also be shown.</text> </paragraph> <paragraph num="(d)"> <text>The inspection shall assess the general cleanliness of the funeral establishment and the restricted funeral establishment and whether there are properly functioning, sanitary restrooms.</text> </paragraph> <paragraph num="(e)"> <text>The business telephone shall be in working order at a funeral establishment and a restricted funeral establishment.</text> </paragraph> <paragraph num="(f)"> <text>A sign or lettering on the windows or building indicating the name of the funeral establishment and the restricted funeral establishment shall be conspicuously displayed, and the name on the sign shall be the same name on the funeral establishment license and the restricted funeral establishment license.</text> </paragraph> <paragraph num="(g)"> <text>If one or more businesses, in addition to a funeral establishment, are operating on the same premises, a separate sign shall indicate the entrance and exit of the funeral establishment and the restricted funeral establishment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>After the inspection is completed, an exit interview shall be conducted to apprise the owner or supervising mortician of the findings of the inspection. A copy of the inspection report shall be left with the owner or supervising mortician who shall verify receipt of the inspection report.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Establishment Inspection Report and Deficiencies."> <paragraph num="A."> <text>The Board shall review the inspection report and make a determination as to whether a deficiency exists.</text> </paragraph> <paragraph num="B."> <text>The Board shall notify the funeral establishment and the restricted funeral establishment in writing of the results of the inspection.</text> </paragraph> <paragraph num="C."> <text>If the funeral establishment licensee and the restricted funeral establishment licensee pass the inspection, the licensees shall prominently display on the premises a statement issued by the Board that the funeral establishment and the restricted funeral establishment have successfully passed the inspection.</text> </paragraph> <paragraph num="D."> <text>If the Board finds a deficiency, the Board shall send to the owner and the restricted funeral establishment within 2 weeks of the inspection notification of the deficiency or failure to pass the inspection.</text> </paragraph> <paragraph num="E."> <text>Correction of Deficiency.</text> <paragraph num="(1)"> <text>Except as provided in this section, an owner and the restricted funeral establishment shall correct a deficiency within 30 days after receipt of notification.</text> </paragraph> <paragraph num="(2)"> <text>The Board may require immediate correction of a deficiency if the Board considers the correction necessary to the interest of public health.</text> </paragraph> <paragraph num="(3)"> <text>The owner or the restricted funeral establishment may request an extension of time for correction of a deficiency.</text> </paragraph> <paragraph num="(4)"> <text>The Board may approve an extension of time for correction of a deficiency.</text> </paragraph> <paragraph num="(5)"> <text>Upon completion of correction of all deficiencies, the owner or the restricted funeral establishment shall notify the Board.</text> </paragraph> <paragraph num="(6)"> <text>Upon notification, the Board or its designee shall re-inspect the funeral establishment or the restricted funeral establishment and the Board shall notify the owner or the restricted funeral establishment in writing of the results of the re-inspection within 1 week.</text> </paragraph> <paragraph num="(7)"> <text>If re-inspection reveals additional deficiencies not cited in the first inspection report, the owner or the restricted funeral establishment shall correct those deficiencies in the time period specified unless an extension of time is requested by the owner or the restricted funeral establishment and approved by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Penalties."> <paragraph num="A."> <text>Failure to allow an inspection of the funeral establishment or the restricted funeral establishment may result in disciplinary action against a funeral establishment license or a restricted funeral establishment license, subject to the hearing requirements as set forth under Health Occupations Article, §7-319, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Failure to comply with a notice to correct deficiencies or violations within the 30-day period, or any reasonable extension granted by the Board under Regulation .06E of this chapter, may result in disciplinary action against a funeral establishment license or the denial of a renewal of a funeral establishment license, subject to the hearing requirements as set forth under Health Occupations Article, §7-319, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Disciplinary action may not be taken against a supervising mortician or funeral director for the acts or omissions of another individual unless the supervising mortician or funeral director knew or should have known of a violation of:</text> <paragraph num="(1)"> <text>Health-General Article, Title 5, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-101, 7-205, and 7-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 20, 1992 (19:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 26, 2001 (28:23 Md. R. 2054)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective September 7, 2009 (36:18 Md. R. 1380)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective September 7, 2009 (36:18 Md. R. 1380)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective November 24, 2014 (41:23 Md. R. 1372)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C adopted effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 8, 2024 (50:26 Md. R. 1131)</annotation> </annotations> </chapter> <chapter num="04" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all persons licensed by the Board of Morticians and Funeral Directors in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Mortician and Funeral Director examination fee ... $265;</text> </paragraph> <paragraph num="B."> <text>Mortician license, initial fee ... $600;</text> </paragraph> <paragraph num="C."> <text>Mortician license, renewal fee ... $600;</text> </paragraph> <paragraph num="D."> <text>Apprenticeship license, initial fee ... $325;</text> </paragraph> <paragraph num="E."> <text>Apprenticeship license, renewal fee ... $325;</text> </paragraph> <paragraph num="F."> <text>Corporation license, renewal fee ... $975;</text> </paragraph> <paragraph num="G."> <text>Establishment license, initial fee ... $700;</text> </paragraph> <paragraph num="H."> <text>Establishment license, renewal fee ... $700;</text> </paragraph> <paragraph num="I."> <text>Funeral director license, initial fee ... $600;</text> </paragraph> <paragraph num="J."> <text>Funeral director license, renewal fee ... $600;</text> </paragraph> <paragraph num="K."> <text>Executor license fee ... $250;</text> </paragraph> <paragraph num="L."> <text>Surviving spouse license, initial fee ... $600;</text> </paragraph> <paragraph num="M."> <text>Surviving spouse license, renewal fee ... $600;</text> </paragraph> <paragraph num="N."> <text>Courtesy card license, initial fee ... $600;</text> </paragraph> <paragraph num="O."> <text>Courtesy card license, renewal fee ... $600;</text> </paragraph> <paragraph num="P."> <text>Late license fee—payable if renewal fee is received more than 15 days after the expiration date ... $400;</text> </paragraph> <paragraph num="Q."> <text>Reinstatement fee—payable after failure to renew the license within 5 years of the date of expiration ... $600;</text> </paragraph> <paragraph num="R."> <text>Inactive status fee ... $300;</text> </paragraph> <paragraph num="S."> <text>Inactive status renewal fee ... $300;</text> </paragraph> <paragraph num="T."> <text>Reactivation of license fee ... $300;</text> </paragraph> <paragraph num="U."> <text>Continuing education vendor fee ... $100;</text> </paragraph> <paragraph num="V."> <text>Duplicate Wall Certificate ... $50;</text> </paragraph> <paragraph num="W."> <text>Duplicate License ... $35;</text> </paragraph> <paragraph num="X."> <text>Licensure Verification / Certification ... $40;</text> </paragraph> <paragraph num="Y."> <text>Failure to notify the Board within 30 days of an address change ... $50;</text> </paragraph> <paragraph num="Z."> <text>Returned check fee ... $40;</text> </paragraph> <paragraph num="AA."> <text>Establishment name change ... $150;</text> </paragraph> <paragraph num="BB."> <text>Non-compliance inspection fee, first offense ... $50;</text> </paragraph> <paragraph num="CC."> <text>Non-compliance inspection fee ... $100.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Terms."> <paragraph num="A."> <text>Licensees shall pay to the Board of Morticians the fees set forth in:</text> <paragraph num="(1)"> <text>Regulation .02C of this chapter by April 30 of every year ending with an even number;</text> </paragraph> <paragraph num="(2)"> <text>Regulation .02E of this chapter annually;</text> </paragraph> <paragraph num="(3)"> <text>Regulation .02F, I, L, and N of this chapter by November 30 of every year ending with an even number; and</text> </paragraph> <paragraph num="(4)"> <text>Regulation .02H of this chapter by November 30 of every year ending with an even number;</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board of Morticians and Funeral Directors shall prorate the fees set forth in Regulation .02A, B, G, H, J, and L of this chapter in 1-year intervals until the date of expiration.</text> </paragraph> <paragraph num="C."> <text>All application fees are non-refundable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-205, 7-206, 7-303(b)(6), 7-304(e), 7-305(b)(1), 7-306(c), 7-308(a)(4), 7-308.1, 7-309(b)(4), 7-310(b)(1)(ii), 7-311(a)(4), 7-314(c)(2), 7-315(a)(3), and 7-321, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 11, 1992 (19:9 Md. R. 879)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective September 27, 1993 (20:19 Md. R. 1472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective November 18, 1994 (21:25 Md. R. 2093); amended permanently effective February 13, 1995 (22:3 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 16, 2009 (36:23 Md. R. 1817)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective March 1, 2001 (28:4 Md. R. 415); amended permanently effective May 14, 2001 (28:9 Md. R. 885)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective October 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective January 1, 2004 (31:4 Md. R. 313); amended permanently effective March 29, 2004 (31:6 Md. R. 509)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 27, 1993 (20:19 Md. R. 1472); January 8, 2024 (50:26 Md. R. 1131)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective March 1, 2001 (28:4 Md. R. 415); amended permanently effective May 14, 2001 (28:9 Md. R. 885)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective October 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This regulation governs a person practicing as a mortician, funeral director, or holder of a surviving spouse license in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Continuing education unit (CEU)” means 50 clock minutes of educational instruction in a Board-approved continuing education program.</text> </paragraph> <paragraph num="(3)"> <text>“Funeral director” means an individual who is licensed by the Board to practice all aspects of mortuary science except for embalming.</text> </paragraph> <paragraph num="(4)"> <text>“Mortician” means an individual who practices mortuary science.</text> </paragraph> <paragraph num="(5)"> <text>“Surviving spouse” means the legal widow or widower of a licensed funeral director or licensed mortician, whose license was in good standing at the time of death, and who, at the time of death, wholly or partly owned and operated a mortuary science business.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Continuing Education Preapproval."> <paragraph num="A."> <text>Continuing education units are automatically approved and do not need to be submitted to the Board if the programs are:</text> <paragraph num="(1)"> <text>Approved by the Academy of Funeral Service Practitioners;</text> </paragraph> <paragraph num="(2)"> <text>Sponsored by national service organizations;</text> </paragraph> <paragraph num="(3)"> <text>Sponsored by State associations;</text> </paragraph> <paragraph num="(4)"> <text>Sponsored by local associations;</text> </paragraph> <paragraph num="(5)"> <text>Provided by suppliers; or</text> </paragraph> <paragraph num="(6)"> <text>Already approved by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensed Maryland funeral establishments and other Maryland licensees may apply to the Board for CEU approval.</text> </paragraph> <paragraph num="C."> <text>A continuing education course or workshop may be qualified for approval if the Board determines that it:</text> <paragraph num="(1)"> <text>Constitutes an organized program of learning, including a symposium, which contributes directly to the professional competency of the licensee;</text> </paragraph> <paragraph num="(2)"> <text>Is related to the practice of mortuary science;</text> </paragraph> <paragraph num="(3)"> <text>Is conducted by individuals considered experts in the subject matter of the program by reason of education, training, or experience; and</text> </paragraph> <paragraph num="(4)"> <text>Is accompanied by a paper, manual, or written outline which substantially describes the subject matter of the program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual seeking to conduct a seminar, workshop, or presentation shall submit for Board approval at least 6 weeks in advance of the proposed seminar, workshop, or presentation the following:</text> <paragraph num="(1)"> <text>Documentation indicating the number of CEUs that will be proposed;</text> </paragraph> <paragraph num="(2)"> <text>A description of the course;</text> </paragraph> <paragraph num="(3)"> <text>Qualifications of the presenter;</text> </paragraph> <paragraph num="(4)"> <text>A course outline; and</text> </paragraph> <paragraph num="(5)"> <text>Any manuals or other documents to be distributed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Post-Approval and Review."> <paragraph num="A."> <text>Each licensee seeking credit for attendance and participation in an education program that is not preapproved shall submit to the Board, within 30 days after completion of the activity, the following:</text> <paragraph num="(1)"> <text>Activity's dates;</text> </paragraph> <paragraph num="(2)"> <text>Subjects covered;</text> </paragraph> <paragraph num="(3)"> <text>Names of instructors and their qualifications; and</text> </paragraph> <paragraph num="(4)"> <text>Number of CEUs requested.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Within 90 days after receipt of the application, the licensee shall be advised by the board, in writing, as to whether the activity is approved and the number of CEUs allowed.</text> </paragraph> <paragraph num="C."> <text>A licensee may be denied credit if the licensee fails to comply with the requirements of this regulation.</text> </paragraph> <paragraph num="D."> <text>A continuing education course or workshop that is already approved may be monitored or reviewed by the Board, and, upon evidence of significant variation in the program presented from the program approved, all or any part of the approved hours granted the program may be disapproved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Continuing Education Requirements."> <paragraph num="A."> <text>The following licensees, except as otherwise stated, at the time of renewal, shall submit documentation of continuing education in the field of mortuary science to the Board:</text> <paragraph num="(1)"> <text>Morticians;</text> </paragraph> <paragraph num="(2)"> <text>Funeral directors; and</text> </paragraph> <paragraph num="(3)"> <text>Surviving spouses.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The morticians, funeral directors, and surviving spouses may begin to accumulate CEUs beginning May 1, 1994 for the renewal period of April 1996 for morticians and November 1997 for funeral directors and surviving spouses.</text> </paragraph> <paragraph num="C."> <text>Except as provided in this regulation, each licensee in the State shall submit, with the license renewal application, a list of a minimum of 12 CEUs each renewal period of continuing education course work approved by continuing education providers as set forth in Regulation .03 of this chapter, or the Board. The Board shall undertake a random audit of a certain percentage of licensees to determine CEU compliance.</text> </paragraph> <paragraph num="D."> <text>CEUs may be obtained by attending and participating in continuing education courses or workshops previously approved by the Board or otherwise meeting the requirements and approved by the Board.</text> </paragraph> <paragraph num="E."> <text>During the time an organization, educational institution, or person is an approved sponsor, all continuing education programs of the organization, educational institution, or person may be approved by the Board.</text> </paragraph> <paragraph num="F."> <text>The Board shall waive continuing education requirements for individuals newly licensed for the first-time renewal of a license.</text> </paragraph> <paragraph num="G."> <text>Except as allowed by the Board, a licensee may not receive credit exceeding nine CEUs of the biennial total required:</text> <paragraph num="(1)"> <text>For correspondence work;</text> </paragraph> <paragraph num="(2)"> <text>For video, sound-recorded, or television programs; or</text> </paragraph> <paragraph num="(3)"> <text>By information transmitted by other similar means as authorized by the Board.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Service as a lecturer or discussion leader may be included to the extent that it contributes to the professional competency of the applicant, but repetitious presentations may not be counted and not more than 50 percent of the total required CEUs may be satisfied in this manner.</text> </paragraph> <paragraph num="I."> <text>The maximum number of CEUs which may be granted for any single continuing education course or workshop single topic is six.</text> </paragraph> <paragraph num="J."> <text>A licensee may not receive more than three CEUs within a renewal period for attending a Board of Morticians and Funeral Directors board meeting.</text> </paragraph> <paragraph num="K."> <text>A licensee may obtain three CEUs for any business courses completed and approved by continuing education providers set forth in Regulation .03 of this chapter, or the Board.</text> </paragraph> <paragraph num="L."> <text>After the renewal period beginning May 1, 2008 for morticians, and December 1, 2008 for funeral directors and surviving spouse licensees, 3 carry-over credits may be granted per renewal cycle.</text> </paragraph> <paragraph num="M."> <text>A licensee shall earn a minimum of 1 CEU hour in an approved course on preneed law per renewal cycle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Exemptions."> <paragraph num="A."> <text>The Board shall grant an exemption from meeting the continuing education requirements to a licensed mortician, funeral director, or surviving spouse license holder who has practiced mortuary science in the State for 40 years and has submitted a one-time request for an exemption to the Board at the time of license renewal.</text> </paragraph> <paragraph num="B."> <text>The Board shall consider a waiver of all or part of the continuing education requirements on a case-by-case basis for a licensed mortician, funeral director, or surviving spouse license holder based on documentation of disability or unusual circumstances.</text> </paragraph> <paragraph num="C."> <text>A mortician, funeral director, or surviving spouse licensee whose license is on an inactive status is not required to meet the continuing education requirements.</text> </paragraph> <paragraph num="D."> <text>Upon reactivation of an inactive license, a mortician, funeral director, or surviving spouse shall submit documentation of CEUs for the current renewal period in which the license is reactivated.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-205 and 7-314(c)(4), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 5, 1994 (21:24 Md. R. 1988)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 7, 2002 (28:26 Md. R. 2273); September 7, 2009 (36:18 Md. R. 1380); February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05J amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154);amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective September 7, 2009 (36:18 Md. R. 1380)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective March 27, 1995 (22:6 Md. R. 474)</annotation> </annotations> </chapter> <chapter num="06" heading="Preneed Contract"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations apply to all preneed contracts entered into by a licensed mortician, a licensed funeral director, and a holder of a surviving spouse license with a buyer.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“At need” means funeral arrangements made after the death of an individual by one authorized to make those arrangements.</text> </paragraph> <paragraph num="(2)"> <text>“Beneficiary” means the individual on whose behalf the preneed contract is purchased.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(4)"> <text>“Buyer” means an individual who agrees to buy certain mortuary science services and merchandise in a preneed contractual arrangement.</text> </paragraph> <paragraph num="(5)"> <text>“Casket vault” means a combination casket and outer burial enclosure.</text> </paragraph> <paragraph num="(6)"> <text>“Contract” means preneed contract.</text> </paragraph> <paragraph num="(7)"> <text>“Irrevocable trust” means an arrangement, which cannot be revoked after its creation, by which property is transferred with the intention that it be administered by a trustee for another's benefit.</text> </paragraph> <paragraph num="(8)"> <text>“Licensee” means an individual who has been issued either a mortician, funeral director, or surviving spouse license by the Board.</text> </paragraph> <paragraph num="(9)"> <text>“Preneed addendum form” means the form provided by the Board to show the allocation of preneed funds.</text> </paragraph> <paragraph num="(10)"> <text>“Preneed contract” means an agreement entered into by a licensed mortician, a licensed funeral director, or holder of a surviving spouse license with a buyer in advance of the death of that individual or beneficiary.</text> </paragraph> <paragraph num="(11)"> <text>“Seller” means a licensed mortician, licensed funeral director, or a holder of a surviving spouse license who agrees to sell certain mortuary science services or merchandise in a preneed contractual arrangement between a buyer and a funeral establishment.</text> </paragraph> <paragraph num="(12)"> <text>“Trustee” means the seller of preneed mortuary services or merchandise selected under the terms of an irrevocable trust arrangement established on behalf of the beneficiary for the purpose of eligibility for Social Security or other governmental benefits.</text> </paragraph> <paragraph num="(13)"> <text>“Unable to perform” means that the seller has died or become disabled, or that the funeral service business has discontinued.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Execution of Preneed Contract."> <paragraph num="A."> <text>Only a licensed mortician, licensed funeral director, or holder of a surviving spouse license may make pre-arrangements and execute preneed contracts with buyers.</text> </paragraph> <paragraph num="B."> <text>The seller shall present to the buyer a preneed contract which contains all of the information set forth in Health Occupations Article, §7-404, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The seller and buyer of a preneed contract shall execute the contract in duplicate, with a copy of the original contract given to the buyer at the time that the contract is signed.</text> </paragraph> <paragraph num="D."> <text>The seller shall state in the preneed contract:</text> <paragraph num="(1)"> <text>The time required for fulfilling the terms and conditions of the contract;</text> </paragraph> <paragraph num="(2)"> <text>The cancellation terms; and</text> </paragraph> <paragraph num="(3)"> <text>The conditions of refunds.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A preneed contract may be funded by a life insurance policy or an annuity contract.</text> </paragraph> <paragraph num="F."> <text>A seller who funds preneed contracts using a life insurance policy or an annuity shall have an insurance license.</text> </paragraph> <paragraph num="G."> <text>A seller who funds preneed contracts using a life insurance policy or annuity shall:</text> <paragraph num="(1)"> <text>Give the buyer a copy of the completed contract form signed and executed by the licensee, buyer, and insurance agent at the conclusion of preneed arrangements;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the insurance company listed on the application for insurance is the recipient of the payment when the buyer is executing payment;</text> </paragraph> <paragraph num="(3)"> <text>Send a copy of the certificate of insurance to the buyer immediately upon receipt of the approved insurance policy; and</text> </paragraph> <paragraph num="(4)"> <text>Present a copy of a filed death certificate policy claim form and any other information required by the insurance company for payment of services provided under the preneed insurance contract.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Funds may not be transferred from a money-trust to an insurance-funded vehicle without the approval and signature on the insurance application of the buyer or legal representative of the buyer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Disposition of Preneed Contract Fund."> <paragraph num="A."> <text>Within 10 days of receiving payment under a preneed contract, the seller shall deposit into an interest-bearing escrow or trust account that is insured by the Federal Deposit Insurance Corporation (FDIC):</text> <paragraph num="(1)"> <text>An amount from the payment that is equal to at least 80 percent of the selling price of a casket or casket vault under the preneed contract; and</text> </paragraph> <paragraph num="(2)"> <text>100 percent of the payment that is for all other goods and services under the preneed contract.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The seller need not have a separate interest-bearing escrow or trust account for each preneed contract executed.</text> </paragraph> <paragraph num="C."> <text>The seller may place in the escrow account with the other funds up to 100 percent of the price of the casket or casket vault.</text> </paragraph> <paragraph num="D."> <text>Interest on Preneed Contract Fund.</text> <paragraph num="(1)"> <text>The interest or dividends earned by the interest-bearing escrow or trust account belongs to the buyer of the contract.</text> </paragraph> <paragraph num="(2)"> <text>The seller shall send to the buyer a tax form stating the amount of the interest accumulated in the account each year that the contract is in effect until the time of death of the beneficiary.</text> </paragraph> <paragraph num="(3)"> <text>It is the responsibility of the buyer to pay the taxes due on that interest.</text> </paragraph> <paragraph num="(4)"> <text>Money remaining in the interest-bearing escrow or trust account after the performance of the contract belongs to the seller.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The seller may not withdraw from the account the money received from the buyer unless the services and merchandise have been provided as agreed to in the contract or unless the buyer terminates the contract.</text> </paragraph> <paragraph num="F."> <text>The seller may withdraw money from the account if one of the following conditions are met:</text> <paragraph num="(1)"> <text>The buyer or legal representative of the buyer forwards a notarized statement and withdrawal request stating that the seller may:</text> <paragraph num="(a)"> <text>Cancel the prepaid contract if revocable; or</text> </paragraph> <paragraph num="(b)"> <text>Transfer the monies to a named substitute trustee if the prepaid contract is irrevocable; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The funeral home presents a copy of a filed or certified death certificate to the banking institution holding the account funds for payment of services provided under a preneed contract.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Obligations of Seller."> <paragraph num="A."> <text>A seller shall provide the buyer with:</text> <paragraph num="(1)"> <text>A general price list of all goods and services for the buyer to keep;</text> </paragraph> <paragraph num="(2)"> <text>A statement of goods and services that are reasonably expected to be required at the time of need, but are not included in the preneed contract;</text> </paragraph> <paragraph num="(3)"> <text>Information concerning cancellation and refund rights under Health Occupations Article, §7-405(d), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>A receipt for all monies received and a copy of the completed forms signed and executed by the seller and the buyer; and</text> </paragraph> <paragraph num="(5)"> <text>A copy of the deposit slip showing the amount of preneed funds deposited into an interest-bearing escrow or trust account with an FDIC insured account under Regulation .04A of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The seller shall perform the contract according to the contract's terms and at the agreed upon price.</text> </paragraph> <paragraph num="C."> <text>The seller shall substitute comparable merchandise when the specified merchandise is unavailable.</text> </paragraph> <paragraph num="D."> <text>The seller is not responsible for those events which are beyond the seller's control, such as changes in cemetery requirements.</text> </paragraph> <paragraph num="E."> <text>Nothing in this regulation shall prohibit a funeral home from its rights to transfer escrow or trust accounts from one institution to another FDIC insured banking institution. The funeral home shall provide the new account information to the buyer along with a copy of the deposit slip within 30 days after transferring preneed funds.</text> </paragraph> <paragraph num="F."> <text>The funeral establishment and the establishment's supervising mortician shall be responsible for providing the services contracted. In the case of a funeral establishment owned by a corporation licensed under Health Occupations Article, §7-309, Annotated Code of Maryland, the supervising mortician and the corporation shall be responsible for the services contracted.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Termination of Preneed Contract."> <paragraph num="A."> <text>Except as otherwise provided in this regulation, a preneed contract may not be terminated by the seller.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided in this section, a seller may not withdraw from the preneed interest-bearing escrow or trust account the money received from a buyer unless the services and merchandise agreed to in the contract have been provided.</text> </paragraph> <paragraph num="C."> <text>At the time a preneed contract is terminated, the seller shall refund to the buyer the payments and interest held for the buyer, if any one of the following conditions occur:</text> <paragraph num="(1)"> <text>The buyer or the legal representative or representatives of the buyer demands in writing a refund of the payments made except as set forth in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The business of the seller is discontinued;</text> </paragraph> <paragraph num="(3)"> <text>The seller is unable to perform under the terms and conditions of the preneed contract for reasons other than an increase in the cost of goods and services; or</text> </paragraph> <paragraph num="(4)"> <text>The buyer fails to pay the entire contract price before the death of the beneficiary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Premature Death of Beneficiary or Buyer."> <text>If the death of the buyer or beneficiary occurs before the terms and conditions of the preneed contract are met, the buyer or legal representative of the beneficiary shall be given the option of withdrawing all funds paid and interest accrued or renegotiating a contract with mutually agreed upon financial adjustments.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Sale or Change in the Ownership of a Funeral Corporation or Establishment."> <paragraph num="A."> <text>A funeral corporation or establishment which is in the process of being sold shall file with the Board a list of preneed contracts and document that the money resulting from the preneed contracts has been set aside in an interest-bearing, federally insured escrow or trust account.</text> </paragraph> <paragraph num="B."> <text>The seller of the funeral corporation or establishment shall document that arrangements have been made with the buyer and with another licensee to honor the preneed contracts.</text> </paragraph> <paragraph num="C."> <text>The seller shall notify the buyers of the preneed contract that the business is being sold and give the buyers an opportunity to either continue the same contractual arrangements with the new owner or to demand a refund of the money paid into the interest-bearing escrow or trust account.</text> </paragraph> <paragraph num="D."> <text>On the death or disability of the seller or if the seller loses or is unable to use that individual's license, the partners or surviving spouse shall notify the Board and document that the preneed contract money has been set aside and remains inviolate, and that arrangements have been made to honor the preneed contracts.</text> </paragraph> <paragraph num="E."> <text>On the death or disability of the seller or if the seller loses or is unable to use that individual's license, the buyer of the preneed contract shall be contacted and given an opportunity to either continue the arrangement with the remaining partners or surviving spouse or to demand a refund of the money paid into the interest-bearing escrow or trust account.</text> </paragraph> <paragraph num="F."> <text>If a licensee files for bankruptcy and that bankruptcy involves assets which include preneed contracts and bank accounts, the bankrupt, or the trustee appointed by the court to handle the bankruptcy, shall:</text> <paragraph num="(1)"> <text>Notify the Board of that bankruptcy filing;</text> </paragraph> <paragraph num="(2)"> <text>Document to the Board the number of preneed accounts that exist;</text> </paragraph> <paragraph num="(3)"> <text>Identify the bank accounts for those preneed documents; and</text> </paragraph> <paragraph num="(4)"> <text>Make assurances to the Board that the preneed accounts will be honored.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If a licensee files for bankruptcy, the licensee shall notify the buyer of a preneed contract of the filing and give the buyer an opportunity to terminate the contract and obtain a full refund of the money paid under the preneed contract or to make arrangements to continue the agreement with the bankrupt seller or another seller.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Irrevocable Trusts."> <paragraph num="A."> <text>A buyer may establish an irrevocable trust with respect to all or any portion of the payment made under the contract in an interest-bearing, federally insured escrow or trust account held by the seller, but only for the purpose of entitling the buyer to be eligible for current Social Security benefits or for benefits under any other plan that restricts eligibility to those with limited assets.</text> </paragraph> <paragraph num="B."> <text>The seller shall present to the buyer a document establishing the irrevocable trust which provides:</text> <paragraph num="(1)"> <text>The appointment of a trustee to sign all necessary papers to effectuate the contract upon the death of the buyer;</text> </paragraph> <paragraph num="(2)"> <text>That the disposition of income earned by the trust inures to the benefit of the buyer;</text> </paragraph> <paragraph num="(3)"> <text>The transfer of the trust funds, if required; and</text> </paragraph> <paragraph num="(4)"> <text>The disposition of the trust funds if:</text> <paragraph num="(a)"> <text>The business of the seller is discontinued,</text> </paragraph> <paragraph num="(b)"> <text>The seller is unable to perform under the terms and conditions of the preneed contract, or</text> </paragraph> <paragraph num="(c)"> <text>The buyer fails to pay the entire contract price before the death of the beneficiary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The buyer or legal representative of the buyer shall retain the right to appoint, as trustee of the irrevocable trust, a substitute trustee.</text> </paragraph> <paragraph num="D."> <text>If the buyer who sets up an irrevocable trust terminates the preneed contract with the seller, the buyer and seller shall take the following actions:</text> <paragraph num="(1)"> <text>The seller shall maintain the funds in trust for the beneficiary until a substitute seller is selected;</text> </paragraph> <paragraph num="(2)"> <text>The buyer shall enter into a new preneed contract with the substitute seller; and</text> </paragraph> <paragraph num="(3)"> <text>The seller shall transfer the trust funds to the substitute seller for placement in a separate interest-bearing escrow account or trust account.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notwithstanding the provisions set forth in these regulations, when a buyer terminates the preneed contract, the funds contained in the irrevocable trust may not be returned to the buyer but the seller shall maintain the funds in trust for the beneficiary.</text> </paragraph> <paragraph num="F."> <text>Funds maintained in an irrevocable trust are not counted as assets with respect to the buyer's Social Security benefits, Medical Assistance eligibility, or any other plan which restricts eligibility to those with limited assets.</text> </paragraph> <paragraph num="G."> <text>The seller shall provide in the document establishing a trust the following notice, conspicuously displayed in 10-point boldface type:</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Prohibitions."> <paragraph num="A."> <text>The following individuals may not enter into a preneed contract with a buyer:</text> <paragraph num="(1)"> <text>The owner or director of a corporation license issued by the Board who is not also a licensed mortician, funeral director, or holder of a surviving spouse license;</text> </paragraph> <paragraph num="(2)"> <text>A holder of an apprentice license;</text> </paragraph> <paragraph num="(3)"> <text>A holder of a courtesy card license; or</text> </paragraph> <paragraph num="(4)"> <text>An individual who is not licensed by the Board as a mortician, funeral director, or surviving spouse license holder.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following individuals may not advertise that they provide preneed contracts:</text> <paragraph num="(1)"> <text>The owner or director of a corporation license issued by the Board who is not also a licensed mortician, funeral director, or holder of a surviving spouse license;</text> </paragraph> <paragraph num="(2)"> <text>A holder of an apprentice license;</text> </paragraph> <paragraph num="(3)"> <text>A holder of a courtesy card license; or</text> </paragraph> <paragraph num="(4)"> <text>An individual who is not licensed by the Board as a mortician, funeral director, or surviving spouse license holder.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-404, 7-405, and 7-504, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 26, 1994 (21:19 Md. R. 1635)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 18, 2002 (29:5 Md. R. 504); August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 18, 2002 (29:5 Md. R. 504); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, I adopted effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F adopted effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E, F adopted effective August 27, 2007 (34:17 Md. R. 1508)</annotation> </annotations> </chapter> <chapter num="07" heading="Surviving Spouse"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the issuance of a surviving spouse license by the State Board of Morticians and Funeral Directors.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Funeral director” means an individual who is licensed by the Board to practice funeral direction.</text> </paragraph> <paragraph num="(3)"> <text>“Mortician” means an individual who practices mortuary science.</text> </paragraph> <paragraph num="(4)"> <text>“Mortuary science” means:</text> <paragraph num="(a)"> <text>To operate a funeral establishment;</text> </paragraph> <paragraph num="(b)"> <text>For compensation, to prepare a dead human body for disposition including disinfecting or preserving a dead human body or any of the body's parts by arterial or cavity injection; or</text> </paragraph> <paragraph num="(c)"> <text>For compensation, to arrange for or make final disposition of a dead human body.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Mortuary science business” means the activities and entity related to providing mortuary science services.</text> </paragraph> <paragraph num="(6)"> <text>“Surviving spouse” means the husband or wife who is predeceased by a licensed mortician or funeral director.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Issuance of a Surviving Spouse License."> <paragraph num="A."> <text>Upon the death of a licensed mortician or funeral director, the surviving spouse shall:</text> <paragraph num="(1)"> <text>Submit to the Board within 30 days of the death of the deceased spouse:</text> <paragraph num="(a)"> <text>An application on a form required by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of the spouse's death;</text> </paragraph> <paragraph num="(c)"> <text>Evidence that the licensed mortician or funeral director either wholly or partly owned the mortuary science business for which an establishment license was issued;</text> </paragraph> <paragraph num="(d)"> <text>Information as to the role that the deceased licensed mortician had in the operation of that business; and</text> </paragraph> <paragraph num="(e)"> <text>Any other information requested by the Board to verify either the ownership or operational details of the mortuary science business with which the deceased mortician or funeral director had been associated; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pay a fee pursuant to COMAR 10.29.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not issue a surviving spouse license to a licensed mortician or funeral director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Authority of Surviving Spouse License."> <text>The surviving spouse license shall authorize the licensee to:</text> <paragraph num="A."> <text>Continue the operation of the mortuary science business of the deceased licensed mortician as it had been operated at the time of the licensed mortician's death; and</text> </paragraph> <paragraph num="B."> <text>Assist with the planning and conducting of funeral services for that mortuary science business.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Duration of Surviving Spouse License."> <text>Subject to the renewal provisions of Regulation .09 of this chapter, a surviving spouse license shall remain effective if the license is used in accordance with Regulation .04 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Conditions of Issuance of a Surviving Spouse License."> <text>The Board may issue a surviving spouse license if the Board receives:</text> <paragraph num="A."> <text>Documentation that the business is to be operated under the direct supervision of a licensed mortician or funeral director;</text> </paragraph> <paragraph num="B."> <text>The name, address, and license number of the mortician or funeral director that will be operating the business;</text> </paragraph> <paragraph num="C."> <text>A written statement from a licensed mortician on a form required by the Board verifying that, if embalming is provided, the licensed mortician will provide direct supervision and perform the embalming or other means of final disposition of dead human bodies on behalf of the mortuary science business requesting the license; and</text> </paragraph> <paragraph num="D."> <text>Documentation that the business continues to be operated in the same manner or mode as it had been operated at the death of the licensed mortician or funeral director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Limitations of Surviving Spouse License."> <paragraph num="A."> <text>A surviving spouse's practice is limited to the conduct of the deceased licensed mortician or funeral director's mortuary business as the mortuary business had been operated during the spouse's lifetime.</text> </paragraph> <paragraph num="B."> <text>Nothing in these regulations precludes the expansion or relocation of the business by a surviving spouse.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Prohibitions."> <paragraph num="A."> <text>The surviving spouse is prohibited from using the surviving spouse license to conduct business in any manner contrary to the provisions set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>The surviving spouse license may not be transferred to another person or to another person's mortuary science business or funeral establishment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Leasing Space."> <paragraph num="A."> <text>The surviving spouse licensee may not be precluded from leasing space in another funeral establishment should the building no longer exist in which the mortuary science business of the deceased licensed mortician or funeral director was conducted.</text> </paragraph> <paragraph num="B."> <text>If space in a funeral establishment is leased, all transactions, stationery, funeral programs, bank or savings and loan records, advertisements, and other documents shall explicitly serve notice to the public that the mortuary science business operated by the surviving spouse is different from the establishment in which the funerals are conducted.</text> </paragraph> <paragraph num="C."> <text>If space in a funeral establishment is leased, the name of the business of the deceased mortician or funeral director shall be used in all advertisements, including obituary notice, with the name and address of the funeral establishment from which the space is leased.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewal."> <text>The license of a surviving spouse may be renewed every 2 years if the surviving spouse:</text> <paragraph num="A."> <text>Submits information on the form required by the Board;</text> </paragraph> <paragraph num="B."> <text>Pays the renewal fee required by the Board pursuant to COMAR 10.29.04; and</text> </paragraph> <paragraph num="C."> <text>Complies with the requirements under Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §7-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 20, 1994 (21:12 Md. R. 1060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> </annotations> </chapter> <chapter num="08" heading="Courtesy Card"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern courtesy cards for those licensed to practice mortuary science in other states or countries who wish to transport bodies from Maryland to their states or countries of licensure or from their states or countries of licensure to Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Committal service” means a ritual conducted at the graveside or crematory following a funeral held at a location other than a cemetery or crematory.</text> </paragraph> <paragraph num="(3)"> <text>“Courtesy card” means a license issued by the Board to licensed practitioners of mortuary science in other states or countries which allows these practitioners to:</text> <paragraph num="(a)"> <text>Remove a dead human body from this State and return the body to another state or country;</text> </paragraph> <paragraph num="(b)"> <text>Return a dead human body from another state or country to this State for final disposition;</text> </paragraph> <paragraph num="(c)"> <text>Fill out the family history portion of the death certificate;</text> </paragraph> <paragraph num="(d)"> <text>Sign the death certificate in the holder's capacity as a licensed practitioner of mortuary science without the assistance of or being under the supervision of a Maryland licensed mortician or funeral director; and</text> </paragraph> <paragraph num="(e)"> <text>Participate in committal services in Maryland without the assistance of a Maryland mortician or funeral director.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Graveside funeral service” means a program or ritual conducted at the cemetery or crematory on behalf of a dead human body instead of one conducted at a funeral home or place of worship.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Courtesy Card."> <paragraph num="A."> <text>An individual already licensed in another state or country to practice mortuary science may apply to the Board for a courtesy card.</text> </paragraph> <paragraph num="B."> <text>An individual licensed to practice mortuary science from another state or country, and who is seeking a courtesy card issued by the Board, shall fulfill the following requirements:</text> <paragraph num="(1)"> <text>Complete an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Have the state or country where the individual is licensed certify, by affixing the seal of that state or country on the completed application, that the applicant is a licensee in good standing in that state or country; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the completed, certified application form along with the fee specified in COMAR 10.29.04.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Authority of Courtesy Card."> <text>Upon issuance of a courtesy card by the Board, the courtesy cardholder is authorized to:</text> <paragraph num="A."> <text>Complete the family history portion of the death certificate and file it with the local health department or Maryland Department of Health;</text> </paragraph> <paragraph num="B."> <text>Complete any other forms, including the burial transit permit, incident to the disposition of a dead human body;</text> </paragraph> <paragraph num="C."> <text>Transport an embalmed or unembalmed body from the state or country of licensure to Maryland for interment or cremation without the assistance of or under the direction of a Maryland mortician or funeral director;</text> </paragraph> <paragraph num="D."> <text>Transport an embalmed or unembalmed body from Maryland to the state or country of licensure for interment or cremation without the assistance of or under the direction of a Maryland mortician or funeral director; and</text> </paragraph> <paragraph num="E."> <text>Conduct a committal service without the assistance of or under the direction of a Maryland mortician or funeral director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Fee for Courtesy Card."> <text>The fee for a courtesy card, as specified in COMAR 10.29.04, is nonrefundable and shall be prorated according to a schedule set by the Board.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Requirements for Renewal of Courtesy Card."> <text>To renew a current courtesy card, the courtesy cardholder shall:</text> <paragraph num="A."> <text>Complete a renewal application form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>Have the state or country where the individual is licensed certify, by affixing the seal of that state or country on the completed application, that the applicant is a licensee in good standing in that state or country; and</text> </paragraph> <paragraph num="C."> <text>Pay the renewal fee as specified in COMAR 10.29.04.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prohibitions."> <text>The holder of a courtesy card may not:</text> <paragraph num="A."> <text>Transfer the card to another individual;</text> </paragraph> <paragraph num="B."> <text>Own a funeral business in Maryland unless the courtesy cardholder is also an owner of or director in a corporation whose license is issued by the Board; or</text> </paragraph> <paragraph num="C."> <text>Except for the requirements listed in Regulation .04 of this chapter, perform any of the acts related to the practice of mortuary science in Maryland including, but not limited to:</text> <paragraph num="(1)"> <text>Arranging for funerals;</text> </paragraph> <paragraph num="(2)"> <text>Conducting funerals in Maryland, including graveside services;</text> </paragraph> <paragraph num="(3)"> <text>Advertising as a practitioner of mortuary science services in Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Signing contracts for funeral services in Maryland; or</text> </paragraph> <paragraph num="(5)"> <text>Preparing deceased human remains in Maryland for disposal.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-101(f) and 7-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> </annotations> </chapter> <chapter num="09" heading="Requirements for Apprenticeship"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth specific criteria which an apprentice shall meet before becoming a licensed mortician or funeral director in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Apprentice” means an individual licensed by the Board who assists and is employed at the same licensed Maryland establishment as the sponsor of the apprentice, and is under the direct supervision of a licensed Maryland mortician or funeral director.</text> </paragraph> <paragraph num="(2)"> <text>“Apprentice sponsor” means a mortician or funeral director who:</text> <paragraph num="(a)"> <text>Has been in good standing with the Board for the previous 5 years;</text> </paragraph> <paragraph num="(b)"> <text>Has been practicing mortuary science as a licensed mortician or funeral director in Maryland at least 5 years immediately before accepting the apprentice;</text> </paragraph> <paragraph num="(c)"> <text>Manages, owns, or is employed by a licensed funeral establishment in Maryland in which the licensed apprentice is employed;</text> </paragraph> <paragraph num="(d)"> <text>Is responsible for the direct supervision of 1,000 hours of work with the apprentice; and</text> </paragraph> <paragraph num="(e)"> <text>Assumes responsibility on their individual license for the delegate or apprentice’s conduct, whether it is consistent or fails to be consistent with the professional standards and provisions set forth in Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(4)"> <text>“Committal services” means a ritual conducted at the graveside or crematory following a funeral held at a location other than a cemetery or crematory.</text> </paragraph> <paragraph num="(5)"> <text>“Delegate” means a licensed mortician or a licensed funeral director employed by the same licensed funeral establishment as the apprentice sponsor and to whom the apprentice sponsor delegates direct supervision.</text> </paragraph> <paragraph num="(6)"> <text>“Direct supervision” has the same meaning as in Health Occupations Article, §7-306(e)(3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Graveside services” means any program or rituals conducted at the cemetery or crematory on behalf of a decedent instead of one conducted at a funeral home or place of worship.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed apprentice” means an apprentice who is licensed by the Board to assist the apprentice sponsor or a licensee delegated by the sponsor to provide direct supervision.</text> </paragraph> <paragraph num="(9)"> <text>“Licensed funeral director” means a funeral director who is licensed by the Board to practice all aspects of mortuary science except embalming.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed mortician” means a mortician who is licensed by the Board to practice mortuary science.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements of Apprenticeship."> <paragraph num="A."> <text>To meet the apprentice requirements set forth in Health Occupations Article, §7-306, Annotated Code of Maryland, an applicant for a mortician’s or funeral director’s license shall be:</text> <paragraph num="(1)"> <text>Employed in the same Maryland establishment as the applicant’s sponsor or the sponsor’s delegate; and</text> </paragraph> <paragraph num="(2)"> <text>Serve under the direct supervision of the applicant’s sponsor or the sponsor’s delegate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applicants shall obtain practical experience in funeral service arrangements, including:</text> <paragraph num="(1)"> <text>20 funeral directions, including at least four of each of the following:</text> <paragraph num="(a)"> <text>A pre-need arrangement;</text> </paragraph> <paragraph num="(b)"> <text>An at-need arrangement for burial;</text> </paragraph> <paragraph num="(c)"> <text>A cremation arrangement; and</text> </paragraph> <paragraph num="(d)"> <text>A cemetery transfer with a service; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>1,000 hours worked under the direct supervision of the apprentice sponsor or the sponsor’s delegate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for a mortician’s license shall obtain practical experience in funeral service arrangements consisting of:</text> <paragraph num="(1)"> <text>Participation in the activities outlined in §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>20 embalmings under the direct supervision of the sponsor or the sponsor’s delegate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Documentation."> <paragraph num="A."> <text>An apprentice shall submit documentation to the Board of completion of the following requirements to be considered for a mortician’s license:</text> <paragraph num="(1)"> <text>Certified transcripts of completion of educational requirements as set forth in Health Occupations Article, §7-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>On the mortician application form provided by the Board, evidence of participation in:</text> <paragraph num="(a)"> <text>20 embalming assists with corresponding copies of the filed death certificates for the embalmed human remains; and</text> </paragraph> <paragraph num="(b)"> <text>20 funeral direction assists, as specified in Regulation .03B(1) of this chapter, with a corresponding published notice of the service for each of the at least 20 decedents and a copy of the filed death certificate;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A notarized statement signed by the apprentice and the apprentice sponsor verifying the completion of 1,000 hours worked under the direct supervision of the apprentice sponsor;</text> </paragraph> <paragraph num="(4)"> <text>Embalming reports signed by the apprentice and apprentice sponsor to document the apprentice’s participation in 20 embalmings; and</text> </paragraph> <paragraph num="(5)"> <text>Documentation on a form provided by the Board and signed by the apprentice and apprentice sponsor or the sponsor’s delegate of participation in at least four of each of the following:</text> <paragraph num="(a)"> <text>A pre-need arrangement;</text> </paragraph> <paragraph num="(b)"> <text>An at-need arrangement for burial;</text> </paragraph> <paragraph num="(c)"> <text>A cremation arrangement; and</text> </paragraph> <paragraph num="(d)"> <text>A cemetery transfer with a service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An apprentice shall submit documentation to the Board of completion of the following requirements to be considered for a funeral director’s license:</text> <paragraph num="(1)"> <text>Certified transcripts of completion of educational requirements as set forth in Health Occupations Article, §7-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>On the funeral director application form provided by the Board, evidence of participation in 20 funeral assists; and</text> </paragraph> <paragraph num="(3)"> <text>A notarized statement signed by the apprentice and the apprentice sponsor verifying the completion of:</text> <paragraph num="(a)"> <text>20 funeral directions, including at least four of each of the following:</text> <paragraph num="(i)"> <text>A pre-need arrangement;</text> </paragraph> <paragraph num="(ii)"> <text>An at-need arrangement for burial;</text> </paragraph> <paragraph num="(iii)"> <text>A cremation arrangement; and</text> </paragraph> <paragraph num="(iv)"> <text>A cemetery transfer with a service; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>1,000 hours worked under the direct supervision of the apprentice sponsor or sponsor’s delegate.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Embalming Requirements for Mortuary Science Apprenticeship."> <paragraph num="A."> <text>If the apprentice sponsor has more than one apprentice, unless otherwise approved by the Board, only one apprentice may receive credit on the same human remains if more than one apprentice assisted the apprentice sponsor.</text> </paragraph> <paragraph num="B."> <text>Applicants for an apprenticeship who are studying to be funeral directors are exempt from the practical aspects of embalming.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Commencement of Apprenticeship."> <paragraph num="A."> <text>The apprentice and the apprentice sponsor or sponsors shall appear before the Board and receive the Board’s approval of the apprenticeship before the apprenticeship commences.</text> </paragraph> <paragraph num="B."> <text>The apprentice and the apprentice sponsor shall sign an agreement with the Board to adhere to the conditions and requirements of apprenticeship before the apprenticeship commences.</text> </paragraph> <paragraph num="C."> <text>The apprentice may have no more than two sponsors who shall attest to the Board what each sponsor is responsible for teaching the apprentice.</text> </paragraph> <paragraph num="D."> <text>The apprentice sponsor shall assume responsibility on their individual license for the delegate or apprentice’s conduct, whether it is consistent or fails to be consistent with the professional standards and provisions set forth in Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Termination of Apprenticeship."> <paragraph num="A."> <text>The sponsor and the apprentice shall submit a notarized statement indicating the:</text> <paragraph num="(1)"> <text>Name of each decedent for whom a funeral arrangement was conducted in which the apprentice assisted;</text> </paragraph> <paragraph num="(2)"> <text>Date of each assisted funeral arrangement;</text> </paragraph> <paragraph num="(3)"> <text>Name of each decedent for whom an embalming was conducted in which the apprentice who is studying to be a mortician assisted; and</text> </paragraph> <paragraph num="(4)"> <text>Date of each assisted embalming.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order for an apprentice to receive credit for the required funeral assists and embalmings, the apprentice shall submit a notarized statement to the Board which reflects the number of assisted funeral arrangements and assisted embalmings completed within 30 days of termination of the apprenticeship to the Board.</text> </paragraph> <paragraph num="C."> <text>In order for the apprentice studying to be a funeral director to receive credit for the required funeral assists, the apprentice shall submit a notarized statement to the Board which reflects the number of assisted funeral arrangements completed within 30 days of termination of the apprenticeship.</text> </paragraph> <paragraph num="D."> <text>Documentation by the apprentice and apprentice sponsor shall be independently submitted to the Board within 30 days of the date of termination of the apprentice sponsor and apprentice relationship as noted in Health Occupations Article, §7-306(c)(4), Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>The Board shall maintain the documentation of apprenticeship requirements for 3 years after the date of termination as noted in §B of this regulation and apply the apprenticeship requirements to the individual seeking a mortician's license.</text> </paragraph> <paragraph num="F."> <text>After 3 years from the date of submission of the documentation by the apprentice to the Board, the Board may not apply credit for the apprenticeship unless an individual petitions the Board to do so citing unusual circumstances which the Board may decide on a case-by-case basis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Laws and Regulations."> <text>All licensed apprentices shall become competent in the knowledge of Maryland and federal laws and regulations as they apply to the funeral profession.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Waiver of Apprenticeship Requirements."> <paragraph num="A."> <text>A mortician or funeral director who is licensed by another state and who is in good standing with the state of licensure may apply in writing to the Board for a waiver of the examination and apprenticeship requirements under Health Occupations Article, §7-303, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Board may issue a mortician or funeral director license to an applicant who is licensed to practice mortuary science or funeral direction in any other state if the applicant:</text> <paragraph num="(1)"> <text>Is a licensed mortician, funeral director, or other equivalent health care occupation in good standing and has practiced continuously in the state of licensure as a mortician for at least 5 years preceding the waiver request;</text> </paragraph> <paragraph num="(2)"> <text>Serves an apprenticeship consisting of at least 1,000 hours in Maryland and documents that apprenticeship to the Board, or has served an apprenticeship of at least 1,000 hours in the applicant's state of initial licensure;</text> </paragraph> <paragraph num="(3)"> <text>Passes the Maryland law portion of the written examination administered by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Pays the fees required as specified in COMAR 10.29.04.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may grant a waiver only if the state in which the applicant is licensed:</text> <paragraph num="(1)"> <text>Grants a similar waiver to Maryland licensees; and</text> </paragraph> <paragraph num="(2)"> <text>Has standards for a mortician or funeral director license that are not lower than those of this State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Change in the Apprenticeship."> <paragraph num="A."> <text>If the apprentice sponsor and apprentice relationship changes, both the apprentice and the apprentice sponsor shall notify the Board of the termination of the apprenticeship in writing and document to the Board in affidavit form the number of hours worked and the funeral arrangements and embalming assists participated in by the apprentice as of the date of termination as noted in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="B."> <text>If the apprentice obtains a new sponsor, both the apprentice and the new sponsor shall appear before the Board to obtain approval of the apprenticeship before the apprenticeship commences.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="General Requirements."> <paragraph num="A."> <text>Education.</text> <paragraph num="(1)"> <text>The applicant shall submit to the Board a certified copy of a high school diploma, G.E.D., or a certified transcript of any post high school degree received.</text> </paragraph> <paragraph num="(2)"> <text>Before an applicant appears before the Board for approval of an apprentice license, the applicant shall be enrolled in or have graduated from a mortuary science program at a school accredited by the American Board of Funeral Service or approved by the Board, with a 2.0 or higher grade point average that is verified with a certified copy of the college transcript, if the applicant has a grade point average.</text> </paragraph> <paragraph num="(3)"> <text>A licensed apprentice who was enrolled in a mortuary science program at the time the license was granted shall remain enrolled in the program for the duration of the apprenticeship unless the licensed apprentice graduates.</text> </paragraph> <paragraph num="(4)"> <text>The applicant shall appear before the Board with a sponsor who:</text> <paragraph num="(a)"> <text>Holds a current valid mortician or funeral director license in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is employed by the same funeral home that employs the apprentice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except as otherwise provided for in Regulation .12 of this chapter, the mortician's apprentice shall obtain an Associate of Arts (AA) Degree in Mortuary Science or its equivalent from a school recognized by the Board within 3 years of commencing the apprenticeship.</text> </paragraph> <paragraph num="C."> <text>Except as otherwise provided for in Regulation .12 of this chapter, the funeral director's apprentice shall obtain an Associate of Arts (AA) degree in funeral service or its equivalent from a school recognized by the Board within 3 years of commencing the apprenticeship.</text> </paragraph> <paragraph num="D."> <text>The 3 years of apprenticeship shall consist of:</text> <paragraph num="(1)"> <text>The initial year of apprenticeship licensure; and</text> </paragraph> <paragraph num="(2)"> <text>Two consecutive apprenticeship licensure renewals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Apply for apprenticeship on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pay the fee as specified in COMAR 10.29.04.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Renewals and Extensions."> <paragraph num="A."> <text>An apprentice may renew the apprenticeship license by submitting a renewal application on the form required by the Board.</text> </paragraph> <paragraph num="B."> <text>An apprentice may renew the apprenticeship license annually for not more than 2 consecutive years.</text> </paragraph> <paragraph num="C."> <text>If after 4 years, consisting of the initial license as an apprentice and two consecutive renewals, the apprentice has not completed the requirements of the apprenticeship, the apprentice may submit to the Board a written request for an extension which the Board may grant upon good cause shown.</text> </paragraph> <paragraph num="D."> <text>If the apprentice fails to obtain the AA degree in mortuary science or an AA degree in funeral service from a school recognized by the Board or fails to meet any other apprenticeship requirements specified in this chapter within 3 years of the commencement of the apprenticeship, the apprentice may apply for an extension of the apprenticeship which the Board may grant for good cause shown.</text> </paragraph> <paragraph num="E."> <text>The Board may not grant more than two extensions to an apprentice.</text> </paragraph> <paragraph num="F."> <text>An apprentice requesting a renewal or extension of the apprenticeship shall pay the fee specified in COMAR 10.29.04 to the Board.</text> </paragraph> <paragraph num="G."> <text>An apprentice requesting an extension shall submit a copy of the transcript from the mortuary science course, funeral service course, or school of higher education to verify pursuit of the educational requirement.</text> </paragraph> <paragraph num="H."> <text>An apprentice who has allowed the apprentice's apprenticeship license to lapse for more than 6 months from the expiration date on the license and who desires to resume the apprenticeship shall appear before the Board with the sponsor and provide documentation of the:</text> <paragraph num="(1)"> <text>Reasons for allowing the apprenticeship license to lapse; and</text> </paragraph> <paragraph num="(2)"> <text>Requirements of apprenticeship which have been met to date.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Board may approve a new period of apprenticeship crediting the number of hours worked and the funeral or embalming assists earned under the prior apprenticeship to the new apprenticeship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Examinations."> <text>An apprentice may take the examination administered by the Board at any time during the apprenticeship.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Prohibitions."> <paragraph num="A."> <text>An apprentice may not assist a mortician or funeral director unless both individuals have current licenses.</text> </paragraph> <paragraph num="B."> <text>An apprentice may participate in making funeral arrangements with the sponsor or the sponsor’s delegate, but may not make funeral arrangements, including pre-need funeral arrangements, embalm human remains, or conduct funerals, including graveside or committal services, unless the apprentice is under the direct supervision of the sponsor or the sponsor’s delegate.</text> </paragraph> <paragraph num="C."> <text>An apprentice may not sign a funeral establishment contract.</text> </paragraph> <paragraph num="D."> <text>An apprentice may not advertise as a provider of funeral services in Maryland.</text> </paragraph> <paragraph num="E."> <text>An apprentice may not sign at-need contracts.</text> </paragraph> <paragraph num="F."> <text>A sponsor may not sponsor more than two apprentices at the same time.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-101, 7-205, 7-305, and 7-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 20, 1996 (23:10 Md. R. 732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 7, 2009 (36:18 Md. R. 1380); August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 7, 2002 (28:26 Md. R. 2273); August 28, 2017 (44:17 Md. R. 835); May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 28, 2017 (44:17 Md. R. 835); May 18, 2020 (47:10 Md. R. 518)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 7, 2002 (28:26 Md. R. 2273); August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C adopted effective September 7, 2009 (36:18 Md. R. 1380)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 29, 2008 (35:26 Md. R. 2250)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D, G amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B, C amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> </annotations> </chapter> <chapter num="10" heading="Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish standards for the imposition of penalties not exceeding $5,000 against any mortuary science practitioner licensee in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §7-316, Annotated Code of Maryland, to suspend or revoke a license.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means, unless the context requires otherwise, a holder of a license issued by the Board to practice mortuary science in Maryland to the extent permitted under Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Penalty” means monetary fine.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of Penalties on Licensees."> <paragraph num="A."> <text>A penalty of not less than $100 or more than $2,500 may be imposed by the Board on a licensee found in violation of any of the following:</text> <paragraph num="(1)"> <text>Advertising falsely;</text> </paragraph> <paragraph num="(2)"> <text>Advertising in a misleading manner;</text> </paragraph> <paragraph num="(3)"> <text>Employing, paying, or offering to pay an individual to obtain business, either in general or for a particular mortician, funeral director, surviving spouse, or funeral establishment.</text> </paragraph> <paragraph num="(4)"> <text>Directly or indirectly paying or offering to pay to obtain mortuary science business;</text> </paragraph> <paragraph num="(5)"> <text>Soliciting or accepting any payment or rebate for recommending any crematory, mausoleum, or cemetery;</text> </paragraph> <paragraph num="(6)"> <text>Soliciting or accepting any share, certificate, or interest in a mortuary science business with a promise or offer to perform services to the buyer at a cost less than that offered to the general public.</text> </paragraph> <paragraph num="(7)"> <text>Selling or offering to sell any share, certificate, or interest in a mortuary science business with a promise or offer to perform services to the buyer at a cost less than that offered to the general public.</text> </paragraph> <paragraph num="(8)"> <text>Practicing mortuary science under a name other than the name:</text> <paragraph num="(a)"> <text>That appears on the license of that person; or</text> </paragraph> <paragraph num="(b)"> <text>Of a partnership in accordance with Health Occupations Article, §7-401, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Violating any provision of Health Occupations Article, §7-316(a)(18), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>Violating any regulation adopted by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A penalty of not less than $200 or more than $3,500 may be imposed by the Board on a licensee found in violation of any of the following:</text> <paragraph num="(1)"> <text>Soliciting mortuary science business, either personally or by an agent, from a dying individual or the relatives of a dead or dying individual, other than through general advertising;</text> </paragraph> <paragraph num="(2)"> <text>Refusing to surrender custody of a dead human body on the demand of a person who is entitled to its custody;</text> </paragraph> <paragraph num="(3)"> <text>Failing to give the written statement required by Health Occupations Article, §7-404, Annotated Code of Maryland, at the time funeral arrangements are made;</text> </paragraph> <paragraph num="(4)"> <text>Violating any State, municipal, or county law, rule, or regulation on the handling, custody, care, transportation, or the disposal of dead human bodies, as required by Health Occupations Article, §7-316(a)(15), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Signing an application for a funeral establishment license if the signer knew or should have known that grounds existed for which the funeral establishment license later was denied, suspended, or revoked;</text> </paragraph> <paragraph num="(6)"> <text>Is disciplined by a licensing or disciplinary authority of any other state or county or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes;</text> </paragraph> <paragraph num="(7)"> <text>Willfully failing to file or record a report as required under law;</text> </paragraph> <paragraph num="(8)"> <text>Willfully impeding or obstructing the filing or recording of a report;</text> </paragraph> <paragraph num="(9)"> <text>Inducing another to fail to file or record the report;</text> </paragraph> <paragraph num="(10)"> <text>Providing professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; or</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Failing to allow an inspection under Health Occupations Article, §7-205(8), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A penalty of not less than $500 or more than $5,000 may be imposed by the Board on a licensee found in violation of any of the following:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or licensee or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulantly or deceptively using a license;</text> </paragraph> <paragraph num="(3)"> <text>Committing fraud or misrepresentation in the practice of mortuary science;</text> </paragraph> <paragraph num="(4)"> <text>Conviction of or plea of guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(5)"> <text>Aiding or abetting an unauthorized person in the practice of mortuary science;</text> </paragraph> <paragraph num="(6)"> <text>Failing, after proper demand, to refund promptly any payments received under a preneed contract;</text> </paragraph> <paragraph num="(7)"> <text>Willfully making or filing a false report or record in the practice of mortuary science;</text> </paragraph> <paragraph num="(8)"> <text>Submitting a false statement to collect a fee;</text> </paragraph> <paragraph num="(9)"> <text>Being professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(10)"> <text>Committing an act of unprofessional conduct in the practice of mortuary science;</text> </paragraph> <paragraph num="(11)"> <text>Refusing, withholding from, denying, or discriminating against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(12)"> <text>Except in an emergency life-threatening situation where it is not feasible or practicable, failing to comply with the Centers for Disease Control's guidelines on universal precautions;</text> </paragraph> <paragraph num="(13)"> <text>Failing to comply with inspection requirements in the time specified by the Board; or</text> </paragraph> <paragraph num="(14)"> <text>Sexual misconduct that includes, but is not limited to:</text> <paragraph num="(a)"> <text>Sexual behavior with a consumer in the context of a professional service to the consumer, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(b)"> <text>Sexual behavior with a consumer of funeral services under the pretext of a benefit;</text> </paragraph> <paragraph num="(c)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a consumer of funeral services;</text> </paragraph> <paragraph num="(d)"> <text>Sexual advances requesting sexual favors;</text> </paragraph> <paragraph num="(e)"> <text>Inappropriate or intentional touching of a sexual nature;</text> </paragraph> <paragraph num="(f)"> <text>A verbal comment of a sexual nature;</text> </paragraph> <paragraph num="(g)"> <text>Physical contact of a sexual nature with a consumer of funeral services;</text> </paragraph> <paragraph num="(h)"> <text>Discussion of unnecessary sexual matters while providing funeral services;</text> </paragraph> <paragraph num="(i)"> <text>The taking of photographs of consumers of funeral services for a sexual purpose;</text> </paragraph> <paragraph num="(j)"> <text>Sexual harassment of staff or students;</text> </paragraph> <paragraph num="(k)"> <text>An unnecessary sensual act or comment; or</text> </paragraph> <paragraph num="(l)"> <text>Sexual contact with an incompetent or unconscious consumer of funeral services.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Factors to be Considered in the Assessment of a Penalty."> <text>In those cases in which the Board determines that the imposition of a penalty is appropriate, the Board shall take into consideration the following factors, without limitations, in determining the amount of penalty:</text> <paragraph num="A."> <text>The extent to which the licensee derived any financial benefit from unprofessional or improper conduct;</text> </paragraph> <paragraph num="B."> <text>The willfulness of the unprofessional or improper conduct;</text> </paragraph> <paragraph num="C."> <text>The extent of actual or potential public harm caused by the unprofessional or improper conduct; and</text> </paragraph> <paragraph num="D."> <text>The cost of investigating and prosecuting the case against the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Payment of a Penalty."> <paragraph num="A."> <text>A licensee shall pay to the Board a penalty imposed under these regulations as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-215, Annotated Code of Maryland, or Health Occupations Article, §7-320, Annotated Code of Maryland, does not automatically stay imposition of a penalty imposed by the Board pursuant to these regulations.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board pursuant to these regulations, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Fiscal Planning to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected pursuant to these regulations into the State's General Fund.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 7-317, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1996 (22:26 Md. R. 2029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective March 5, 2001 (28:4 Md. R. 418)</annotation> </annotations> </chapter> <chapter num="11" heading="Complaint Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the handling of all complaints against licensees of the State Board of Morticians and Funeral Directors.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(3)"> <text>“Cease and desist letter” means a letter commanding an individual to stop engaging in certain prohibited activities under the Act.</text> </paragraph> <paragraph num="(4)"> <text>“Committee” means the Complaint Committee of the Board, which includes at least one mortician member of the Board and at least one consumer member of the Board, and which is assisted by Board counsel provided by the Attorney General’s Office and Board administrative personnel.</text> </paragraph> <paragraph num="(5)"> <text>“Complaint” means a report of a potential violation during the performance of mortuary services against an individual licensed by the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Complainant” means an individual who files a complaint with the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Confidential” means that neither the complaint nor resolution of it by the Board may be released to the public, including to the complainant, pursuant to General Provisions Article, §4–333, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Consent order” means a written agreement reached by the licensee and the Board as a result of a prehearing conference which sets forth the terms and conditions regarding the licensee’s ability or inability to practice and is subject to release to the public, pursuant to General Provisions Article, §4–333, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Disposition agreement” means a confidential agreement entered into between the Board and the licensee whereby the Board agrees to resolve the matter after the filing of charges in return for the licensee's agreeing to meet certain specified terms and conditions which remain a permanent part of the licensee's record and can be used in considering sanction should further disciplinary action be required.</text> </paragraph> <paragraph num="(10)"> <text>“Educational letter” means a dismissal notice which specifically sets forth in an instructive manner the areas of the licensee's practice which require improvement and which, when applicable, includes a warning that any further complaints for the same or similar activities may result in disciplinary charges under the Act.</text> </paragraph> <paragraph num="(11)"> <text>“Informal meeting” means a voluntary meeting of the Board and the licensee, either on the licensee's own initiative or on the Board's initiative, following notice to the licensee regarding the precise purpose of the meeting in the context of an ongoing investigation or inquiry.</text> </paragraph> <paragraph num="(12)"> <text>“Jurisdiction” means within the Board's authority as set forth in the Act.</text> </paragraph> <paragraph num="(13)"> <text>“Letter of admonishment” means a letter which sets forth that the:</text> <paragraph num="(a)"> <text>Board has probable cause to charge the licensee with a violation of a specific provision of the Board's Act;</text> </paragraph> <paragraph num="(b)"> <text>Licensee is admonished and ordered to cease and desist from all further activities in violation of its Act; and</text> </paragraph> <paragraph num="(c)"> <text>Letter will become part of the licensee's permanent record with the Board but will be treated as part of the confidential record maintained by the Board on the licensee and can be considered in determining sanctions for any subsequent violation of the Act.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Letter of dismissal” means a letter from the Board advising the licensee that:</text> <paragraph num="(a)"> <text>The investigation into the allegations raised has been closed;</text> </paragraph> <paragraph num="(b)"> <text>Violations were not found; and</text> </paragraph> <paragraph num="(c)"> <text>The information obtained during the course of the investigation will be treated as a confidential record of the licensee maintained by the Board.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Letter of surrender” means an agreement between the Board and licensee whereby the Board specifies the terms for the complete and unequivocal surrender of the licensee's license and right to practice mortuary science.</text> </paragraph> <paragraph num="(16)"> <text>“Licensee” means an individual licensed by the Board of Morticians and Funeral Directors against whom a complaint has been filed.</text> </paragraph> <paragraph num="(17)"> <text>“Mortuary services” means any service provided to a decedent or their family that requires any license issued by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Filing of Complaint."> <paragraph num="A."> <text>A complaint may come to the Board by any means from the public or a Board member.</text> </paragraph> <paragraph num="B."> <text>A complaint received by the Board shall be recorded on a complaint log.</text> </paragraph> <paragraph num="C."> <text>When the complaint to the Board against a licensee is filed, the complaint will be completed on a form devised by the Board and according to the instructions provided.</text> </paragraph> <paragraph num="D."> <text>In an emergency situation the Board may act upon a complaint received by telephone if that complaint is followed up in writing.</text> </paragraph> <paragraph num="E."> <text>The Board may also act upon a complaint signed by a Board member if the complaint is recorded on the log and the Board member refrains from further participation in the discussion or vote in the matter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Disposition of Complaint by Complaint Committee."> <paragraph num="A."> <text>Upon receipt of a complaint, the administrative personnel shall present the complaint to the Complaint Committee of the Board.</text> </paragraph> <paragraph num="B."> <text>The Committee shall review the complaint and make a determination as to whether the complaint falls within the Board's jurisdiction.</text> </paragraph> <paragraph num="C."> <text>If the Committee determines that the complaint does not fall within the Board’s jurisdiction, the determination shall be reported to the Board at its next regularly scheduled Board meeting. If the Board concurs with the recommendation of the Committee, the Board shall vote to close the complaint with no Board action.</text> </paragraph> <paragraph num="D."> <text>If the Board determines that the complaint falls under the jurisdiction of another agency, the Board staff shall refer the complaint to the appropriate agency.</text> </paragraph> <paragraph num="E."> <text>If the Committee determines that the complaint would fall within the Board’s jurisdiction, the Board shall vote to open the complaint for investigation.</text> </paragraph> <paragraph num="F."> <text>The Committee shall review the licensee's response or report and make a recommendation to the Board for disposition of the case. The Committee may request that:</text> <paragraph num="(1)"> <text>Supplemental information be obtained;</text> </paragraph> <paragraph num="(2)"> <text>A supplemental investigation be conducted; or</text> </paragraph> <paragraph num="(3)"> <text>Clarification of the responses or report be received.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The complaint committee shall, by a majority of the members present at a regularly scheduled Committee meeting, make a recommendation to the Board based on the following actions:</text> <paragraph num="(1)"> <text>That the Board take informal action by issuing one of the following:</text> <paragraph num="(a)"> <text>Cease and desist letter;</text> </paragraph> <paragraph num="(b)"> <text>Educational letter;</text> </paragraph> <paragraph num="(c)"> <text>Informal meeting;</text> </paragraph> <paragraph num="(d)"> <text>Letter of admonishment; or</text> </paragraph> <paragraph num="(e)"> <text>Letter of dismissal; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>That the Board take formal action by voting to charge the licensee with a violation of the Act and subsequently making a referral of the case to the Attorney General's Office for prosecution.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Board Action on Complaints."> <paragraph num="A."> <text>The Board, upon receipt of the Committee's recommendations, shall take one of the following actions:</text> <paragraph num="(1)"> <text>Accept the Committee's recommendations;</text> </paragraph> <paragraph num="(2)"> <text>Accept the Committee's recommendation with modifications; or</text> </paragraph> <paragraph num="(3)"> <text>Reject the Committee's recommendations with instructions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board refers a case to the Attorney General's Office for prosecution, a liaison shall be assigned to assist the prosecutor with the preparation of the charges.</text> </paragraph> <paragraph num="C."> <text>Upon receipt of the charges prepared by the prosecutor, the Board shall vote to ratify the charge document.</text> </paragraph> <paragraph num="D."> <text>After a prehearing conference or a hearing on the charges, the Board may vote to:</text> <paragraph num="(1)"> <text>Discuss the complaint or any sections of the charges;</text> </paragraph> <paragraph num="(2)"> <text>Find no violation;</text> </paragraph> <paragraph num="(3)"> <text>Find a violation and issue a disposition agreement;</text> </paragraph> <paragraph num="(4)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(5)"> <text>Issue a reprimand;</text> </paragraph> <paragraph num="(6)"> <text>Place a licensee on probation, with or without conditions;</text> </paragraph> <paragraph num="(7)"> <text>Charge a monetary penalty;</text> </paragraph> <paragraph num="(8)"> <text>Issue a suspension of the licensee;</text> </paragraph> <paragraph num="(9)"> <text>Revoke a license; or</text> </paragraph> <paragraph num="(10)"> <text>Combine any of the above.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition, following the Board’s vote, the Board shall issue a written document regarding the action taken. All of these documents will be sent to the licensee. The Board shall notify the complainant of the resolution of the complaint, as permitted by General Provisions Article, §4–333, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Confidentiality."> <paragraph num="A."> <text>A disposition agreement remains confidential and may only be released to the public if the licensee is found guilty of a violation of a provision of the agreement or subsequent violation of the Act, after a hearing, pursuant to Health Occupations Article, §7-319, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An educational letter and a letter of admonishment is treated as a confidential record maintained by the Board on the licensee.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §7-205(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 15, 1996 (23:14 Md. R. 1009)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 713)</annotation> </annotations> </chapter> <chapter num="12" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs advertising by all persons licensed by the Board of Morticians and Funeral Directors in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means calling to the attention of the public the services one has to offer.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Morticians.</text> </paragraph> <paragraph num="(3)"> <text>Licensee.</text> <paragraph num="(a)"> <text>“Licensee” means a licensed mortician, funeral director, or a surviving spouse license holder who holds a current license to practice mortuary science in Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Licensee” may mean a funeral establishment in some instances.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>A licensee may:</text> <paragraph num="(1)"> <text>Advertise mortuary science services subject to the provisions of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Use the initials LM or LFD after their name to indicate that the licensee is authorized to practice mortuary science or funeral direction as a:</text> <paragraph num="(a)"> <text>Licensed mortician (LM); or</text> </paragraph> <paragraph num="(b)"> <text>Licensed funeral director (LFD); and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Represent to the public that the licensee is a:</text> <paragraph num="(a)"> <text>Licensed mortician (LM); or</text> </paragraph> <paragraph num="(b)"> <text>Licensed funeral director (LFD).</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An advertisement may not contain statements:</text> <paragraph num="(1)"> <text>Containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Intended to or likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to laypersons;</text> </paragraph> <paragraph num="(5)"> <text>Conveying the impression that the licensee could influence improperly any public body, official, corporation, or person on behalf of the public;</text> </paragraph> <paragraph num="(6)"> <text>Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent individual to misunderstand or be deceived;</text> </paragraph> <paragraph num="(7)"> <text>Containing representations that the licensee is willing to provide services which are illegal under the laws or regulations of Maryland or the United States; or</text> </paragraph> <paragraph num="(8)"> <text>That fail to state that the licensee is licensed to practice mortuary science in Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall be accountable under this regulation if the licensee uses an agent or partnership to implement actions prohibited by this regulation.</text> </paragraph> <paragraph num="D."> <text>A funeral establishment may advertise that it is able to provide preneed services as specified in Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <paragraph num="A."> <text>A licensee may not engage in solicitation, including, but not limited to, in-person, telephone, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation, or overreaching; or</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .03B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall be accountable under this regulation if the licensee uses an agent or partnership to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Prohibitions."> <paragraph num="A."> <text>A licensee is prohibited from:</text> <paragraph num="(1)"> <text>Soliciting mortuary science business from a dying individual or the relatives of a dying individual other than through general advertising;</text> </paragraph> <paragraph num="(2)"> <text>Employing, paying, or offering to pay a person to obtain business, either in general or for a particular mortician, funeral director, surviving spouse, or funeral establishment; and</text> </paragraph> <paragraph num="(3)"> <text>Soliciting or accepting payment or rebate for recommending any crematory, mausoleum, or cemetery, suggesting that a dead human body be disposed of there.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless licensed by the Board, an individual may not:</text> <paragraph num="(1)"> <text>Use the initials LM or LFD after the name of the individual to indicate that the individual is authorized to practice mortuary science or funeral direction as a:</text> <paragraph num="(a)"> <text>Licensed mortician (LM); or</text> </paragraph> <paragraph num="(b)"> <text>Licensed funeral director (LFD); or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Represent to the public that the individual is a:</text> <paragraph num="(a)"> <text>Licensed mortician (LM); or</text> </paragraph> <paragraph num="(b)"> <text>Licensed funeral director (LFD).</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An apprentice licensee may not advertise the provision of mortuary science services in Maryland.</text> </paragraph> <paragraph num="D."> <text>A courtesy card holder may not advertise the provision of mortuary science services in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalties for Violation."> <text>A violation of these regulations pertaining to the use of advertising may result in disciplinary action against the licensee under Health Occupations Article, §7-316, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §7-205(7), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1996 (22:26 Md. R. 2029)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 4, 2022 (49:7 Md. R. 466)</annotation> </annotations> </chapter> <chapter num="13" heading="Rehabilitation Committee"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to the Rehabilitation Committee of the Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="B."> <text>The President of the Board shall appoint the Rehabilitation Committee members.</text> </paragraph> <paragraph num="C."> <text>The Rehabilitation Committee is a panel which consists of a licensee member and a consumer member of the Board assisted by administrative staff and Board Counsel.</text> </paragraph> <paragraph num="D."> <text>The Rehabilitation Committee shall:</text> <paragraph num="(1)"> <text>Determine where meetings are held and the frequency of the meetings;</text> </paragraph> <paragraph num="(2)"> <text>Keep confidential minutes and maintain those minutes in a confidential file at the Board office; and</text> </paragraph> <paragraph num="(3)"> <text>Review and approve the procedures established by the Rehabilitation Committee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“Committee” means the Rehabilitation Committee of the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Formal agreement” means a written agreement between the Committee and the practitioner that lists:</text> <paragraph num="(a)"> <text>The individual requirements for the practitioner in the program; and</text> </paragraph> <paragraph num="(b)"> <text>The conditions that shall be met by the practitioner.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Impaired practitioner” means a licensee who is not capable of practicing mortuary science competently and is in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition.</text> </paragraph> <paragraph num="(5)"> <text>“Practitioner” means a licensed apprentice, funeral director, mortician, or surviving spouse.</text> </paragraph> <paragraph num="(6)"> <text>“Program” means the treatment and rehabilitation plan established by the Committee and agreed upon by the practitioner.</text> </paragraph> <paragraph num="(7)"> <text>“Treatment entity” means a licensed health care provider or licensed center for the evaluation, care, or rehabilitation, or all of these, of an impaired practitioner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Functions."> <paragraph num="A."> <text>The Committee, without cost to the Board, shall provide appropriate rehabilitative assistance to impaired practitioners.</text> </paragraph> <paragraph num="B."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Make an initial review of the nature of the practitioner's impairment to determine an appropriate course of action;</text> </paragraph> <paragraph num="(2)"> <text>Review documentation pertinent to the impairment which has been made available to the Committee;</text> </paragraph> <paragraph num="(3)"> <text>Make appropriate referrals for:</text> <paragraph num="(a)"> <text>Evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Treatment; or</text> </paragraph> <paragraph num="(c)"> <text>Rehabilitation; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Design, or request a treatment entity to design, a program that is generally accepted by an insurer which allows an impaired practitioner to practice mortuary science in a competent manner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Criteria."> <paragraph num="A."> <text>Admission to the program may be the result of:</text> <paragraph num="(1)"> <text>Self-referral;</text> </paragraph> <paragraph num="(2)"> <text>Formal complaint; or</text> </paragraph> <paragraph num="(3)"> <text>Referral by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If participation in the program is a result of a voluntary action by an impaired practitioner, which results in a formal agreement with the Committee to undergo a course of treatment or rehabilitation, the Committee shall report to the Board only noncompliance with the agreement.</text> </paragraph> <paragraph num="C."> <text>The Committee may not report to the Board those impaired practitioners who self-refer or who come to the attention of the Committee by a formal complaint if those practitioners comply with the formal agreement or program.</text> </paragraph> <paragraph num="D."> <text>The Committee shall report to the Board any noncompliance with the treatment program, if the Board referral is the result of a public or nonpublic order or informal discipline imposed by the Board.</text> </paragraph> <paragraph num="E."> <text>The impaired practitioner for whom the program was designed shall pay all costs associated with the evaluation, treatment, and rehabilitation program.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-205 and 7-408, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514)</annotation> </annotations> </chapter> <chapter num="14" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter permits the Board to disclose investigative information to other agencies, or other entities, or both, under certain circumstances.</text> </paragraph> <paragraph num="B."> <text>A custodian may disclose information in a licensing or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>The custodian may find that a compelling public purpose warrants disclosure of information in a licensing or investigative file, regardless of whether there has been a request for the information, and may disclose the information under the following circumstances:</text> <paragraph num="A."> <text>The information concerns possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>The information concerns a possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>The information concerns conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §7-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 15, 2002 (29:7 Md. R. 621)</annotation> </annotations> </chapter> <chapter num="15" heading="Family Security Trust Fund"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the collection of fees from licensed funeral establishments for claimants to recover compensation from the Family Security Trust Fund for an actual pre-need trust fund loss that occurred in this State due to theft, embezzlement, false pretenses, forgery, fraud, or misrepresentation by a licensed mortician, funeral director, or holder of a surviving spouse license.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to all preneed contracts entered into by a licensed mortician, funeral director, or a holder of a surviving spouse license with a buyer, including those preneed contracts arranged on behalf of a holder of a corporate license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advisory Committee” means a committee comprised of three Board members and a representative from two of the trade associations which is assisted by Board Counsel provided by the Attorney General’s Office and Board Administrative personnel to administer the Fund.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(3)"> <text>“Claim” means a request filed in writing, under oath, with supporting documentation by a claimant to obtain compensation from the Family Security Trust Fund for a preneed trust fund loss as a result of malfeasance, default, failure, or insolvency of any licensee under Health Occupations Article, §7-4A-06, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Claimant” means an individual, or legal representative of the individual who files a claim for loss.</text> </paragraph> <paragraph num="(5)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may do by law.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Fund” means the Family Security Trust Fund, a special, nonlapsing, interest bearing account.</text> </paragraph> <paragraph num="(7)"> <text>“Preneed contract” means an agreement entered into by a licensed mortician, a licensed funeral director, or a holder of a surviving spouse license with a supervising mortician or a supervising funeral director with a buyer in advance of the death of that individual or beneficiary.</text> </paragraph> <paragraph num="(8)"> <text>“Seller” means a licensed mortician or licensed funeral director who agrees to sell certain mortuary sciences services or merchandise in a contractual arrangement between a buyer and a funeral establishment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Mandatory Fees."> <paragraph num="A."> <text>A licensed funeral establishment may not be exempt from the fees outlined in this regulation.</text> </paragraph> <paragraph num="B."> <text>The Board shall send out fee notices to the licensed establishments via first class mail or by any electronic means by September 1.</text> </paragraph> <paragraph num="C."> <text>Annual payments shall be due on November 30 of every year. All active licensed establishments shall be required to pay a fee of $375 to the Family Security Trust Fund.</text> </paragraph> <paragraph num="D."> <text>A late fee of $500 will be assessed on December 1 for any licensed establishment that is delinquent in paying the mandatory contribution to the Fund.</text> </paragraph> <paragraph num="E."> <text>If the establishment does not pay the mandatory fee and the late fee by December 30, the Committee shall refer the delinquent establishments to the Board for formal action to include possible suspension of the supervising mortician license.</text> </paragraph> <paragraph num="F."> <text>In addition to any applicable mandatory late fee, the Board:</text> <paragraph num="(1)"> <text>Shall assess a $40 fee for returned checks; and</text> </paragraph> <paragraph num="(2)"> <text>May not issue a license until the payment is made, including the late fee if after December 1.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A licensee is not entitled to a refund of its contribution to the Fund.</text> </paragraph> <paragraph num="H."> <text>Mandatory contributions to the Fund may not be prorated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="The Family Security Trust Fund."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Collect the mandatory contributions;</text> </paragraph> <paragraph num="(2)"> <text>Deposit the funds;</text> </paragraph> <paragraph num="(3)"> <text>Track interest; and</text> </paragraph> <paragraph num="(4)"> <text>Process claims for loss that occurred on or after January 1, 2010.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All fees shall be deposited with the State Treasurer into a separate account known as the Family Security Trust Fund. The Fund may not be transferred to or revert to the General Fund of the State.</text> </paragraph> <paragraph num="C."> <text>All moneys deposited in the Fund shall be used only for the purposes expressly authorized by Health Occupations Article, §7-04A-05, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Fund shall accumulate interest income which shall be credited to the Fund.</text> </paragraph> <paragraph num="E."> <text>Once the Fund has accumulated a balance of $1,000,000 the Board shall cease to collect the annual fee.</text> </paragraph> <paragraph num="F."> <text>If the Fund falls below $1,000,000, the Board shall reinstate a fee up to $375 to be assessed by the Board.</text> </paragraph> <paragraph num="G."> <text>The Fund shall be maintained at $1,000,000 principal level plus interest.</text> </paragraph> <paragraph num="H."> <text>The Board may expend monies in the Fund for the following purposes:</text> <paragraph num="(1)"> <text>To make reimbursements on approved claims; and</text> </paragraph> <paragraph num="(2)"> <text>To pay the expenses of the Board for administering the Fund, including appropriate experts, or legal counsel, accountants, consultants, and agents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Filing a Claim."> <paragraph num="A."> <text>Complaints shall be processed pursuant to COMAR 10.29.11.</text> </paragraph> <paragraph num="B."> <text>The Board shall issue a final order against a licensee for violation involving a transaction that relates to preneed funeral planning that occurred in the State and falls within its jurisdiction.</text> </paragraph> <paragraph num="C."> <text>The claimant shall:</text> <paragraph num="(1)"> <text>Complete a claim form devised by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Provide a signed preneed contract and copies of documentation of any and all money transactions regarding the preneed contract; and</text> </paragraph> <paragraph num="(3)"> <text>Present all claims for losses to the Board within 1 year:</text> <paragraph num="(a)"> <text>After the death of the person who is the subject of the preneed contract;</text> </paragraph> <paragraph num="(b)"> <text>Upon the discovery by the claimant of the defalcation; or</text> </paragraph> <paragraph num="(c)"> <text>At a later date at the discretion of the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall consider each claim on a case by case basis.</text> </paragraph> <paragraph num="E."> <text>All claims shall be filed with the Fund.</text> </paragraph> <paragraph num="F."> <text>Claims shall be filed in accordance with Health Occupations Article, §§7-4A-07—7-4A-08, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Hearings."> <text>Hearings shall be conducted in accordance with Health Occupations Article, §7-319, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Restitution."> <paragraph num="A."> <text>A claimant may receive compensation from the Fund for an actual preneed trust fund loss that occurred on or after January 1, 2010. All payments shall be a matter to be decided by the full Board in its discretion.</text> </paragraph> <paragraph num="B."> <text>Restitution may only be obtained from the Fund if adequate funds are not available from the preneed seller.</text> </paragraph> <paragraph num="C."> <text>The amount of compensation recoverable by a claimant shall be restricted to the actual monetary loss incurred by the claimant.</text> </paragraph> <paragraph num="D."> <text>The President of the Board shall sign claims by designation to appropriate staff for payment from the Fund.</text> </paragraph> <paragraph num="E."> <text>The Board shall order full or partial payment of a claim.</text> </paragraph> <paragraph num="F."> <text>If at any time there are not sufficient funds on hand to pay all claims in full, the Board may, in its discretion, pay the approved claims pro rata or defer payment until such time as adequate funds are available.</text> </paragraph> <paragraph num="G."> <text>The Board shall determine the maximum cumulative amounts which shall be paid in respect to any one claim or multiple claims by a single claimant arising from the same licensee involved in either a client or fiduciary relationship. The percentage of payment on the dollar remains the same for all victims of the same licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery of Funds."> <paragraph num="A."> <text>In the event restitution is made to a claimant under this chapter, the Board may bring action to the extent authorized by statute against any person, including a licensee who is determined by the Board to be responsible for the claim.</text> </paragraph> <paragraph num="B."> <text>A licensee found guilty of malfeasance, misfeasance, default, failure, or insolvency may not be considered for reinstatement to an active status until all money paid from the fund is repaid in full, plus interest from the time the payment is made.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§7-4A-01, 7-4A-03(h), 7-4A-04—7-4A-13, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective April 9, 2018 (45:7 Md. R. 345)</annotation> </annotations> </chapter> <chapter num="16" heading="Crematories — Definitions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines terms used in COMAR 10.29.17 — COMAR 10.29.20.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In COMAR 10.29.17 — COMAR 10.29.20, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means the publication, dissemination, or circulation of any oral or written matter, including labeling, which directly or indirectly calls to the attention of the public the goods and services one has to offer.</text> </paragraph> <paragraph num="(2)"> <text>“Alkaline hydrolysis” means the process of reducing human remains using water, alkaline chemicals, and heat inside a watertight vessel to accelerate decomposition.</text> </paragraph> <paragraph num="(3)"> <text>“Authorizing agent” means an individual who has legal authority to arrange for and make decisions regarding the final disposition of human remains, including cremation or alkaline hydrolysis.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(5)"> <text>“Consumer” includes a funeral establishment contracting with a crematory or the authorizing agent of a decedent contracting with a crematory.</text> </paragraph> <paragraph num="(6)"> <text>“Cremated human remains” means the recoverable bone fragments of a deceased person that result from the completion of cremation.</text> </paragraph> <paragraph num="(7)"> <text>“Cremation” means the disposition of a dead human body by means of incineration.</text> </paragraph> <paragraph num="(8)"> <text>“Cremator” means the machinery within which the process of cremation begins.</text> </paragraph> <paragraph num="(9)"> <text>“Crematory” means a building, portion of a building, or structure that houses the necessary appliances and facilities for cremation, alkaline hydrolysis, or both.</text> </paragraph> <paragraph num="(10)"> <text>“Crematory container” means a readily combustible, rigid container in which human remains are sent to the crematory and then placed in the cremator for cremation.</text> </paragraph> <paragraph num="(11)"> <text>“Crematory equipment” means either:</text> <paragraph num="(a)"> <text>A cremator; or</text> </paragraph> <paragraph num="(b)"> <text>A hydrolysis unit.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Decedent” means a dead human being.</text> </paragraph> <paragraph num="(13)"> <text>“Embalming” means the disinfection and preserving of human remains by arterial or cavity injection or any other type of preservation.</text> </paragraph> <paragraph num="(14)"> <text>“Engage in the operation of a crematory” means controlling or managing a crematory.</text> </paragraph> <paragraph num="(15)"> <text>“Holding facility” means an area, within or adjacent to a crematory, designed for the retention of human remains before cremation or alkaline hydrolysis.</text> </paragraph> <paragraph num="(16)"> <text>Human Remains.</text> <paragraph num="(a)"> <text>“Human remains” means:</text> <paragraph num="(i)"> <text>The body of a deceased person; or</text> </paragraph> <paragraph num="(ii)"> <text>A part of a body or limb that has been removed from a living person.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Human remains” includes the body or part of a body or limb in any state of decomposition.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Hydrolysis container” means a container, including a body bag, in which human remains are sent to the crematory for alkaline hydrolysis, but the human remains may be removed prior to the start of the process for alkaline hydrolysis.</text> </paragraph> <paragraph num="(18)"> <text>“Hydrolysis unit” means the watertight vessel in which the process of alkaline hydrolysis occurs.</text> </paragraph> <paragraph num="(19)"> <text>“Hydrolyzed human remains” means the recoverable bone fragments of a deceased person that result from the completion of alkaline hydrolysis.</text> </paragraph> <paragraph num="(20)"> <text>“Office” means the Office of Cemetery Oversight.</text> </paragraph> <paragraph num="(21)"> <text>“Permit” means a license issued by the Board to allow a person to operate a business which engages in the operation of a crematory or to act as a registered crematory operator.</text> </paragraph> <paragraph num="(22)"> <text>“Permit holder” means the holder of a permit issued under Health Occupations Article, Title 7, Annotated Code of Maryland, to operate a crematory or to act as a registered crematory operator.</text> </paragraph> <paragraph num="(23)"> <text>“Person” means an individual, personal representative, or a corporation that is the operator of a mortuary science business where the practice of mortuary science is conducted for the corporation by a licensed mortician or funeral director, a partnership, or professional association, each comprised of one or more licensed morticians or funeral directors.</text> </paragraph> <paragraph num="(24)"> <text>“Processed human remains” means the end result of pulverization.</text> </paragraph> <paragraph num="(25)"> <text>“Pulverization” means the process following cremation or alkaline hydrolysis of crushing, grinding, or milling cremated or hydrolyzed human remains into fine particles or powder, leaving bone fragments reduced to 5 millimeters or less.</text> </paragraph> <paragraph num="(26)"> <text>“Registered crematory operator” means an individual registered to operate a crematory as a sole proprietor or on behalf of a sole proprietor or permit holder.</text> </paragraph> <paragraph num="(27)"> <text>“Responsible party” means a sole proprietor or the individual designated by a corporation, limited liability company, or partnership, which holds a permit to engage in the operation of a crematory, to be responsible for the operations of the crematory.</text> </paragraph> <paragraph num="(28)"> <text>“Sealable container” means a container in which processed human remains can be placed and sealed so as to prevent leakage of the processed human remains or the entry of any foreign material.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Business Regulation Article, §5-101; Health-General Article, §5-508; Health Occupations Article, §§7-101, 7-102, and 7-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2014 (41:7 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="17" heading="Crematories — Permit, Licensing, and Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the crematory permit process and fees for persons regulated under Health Occupations Article, Title 7, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Permit — Issuing Agency."> <paragraph num="A."> <text>Office of Cemetery Oversight. An individual shall obtain a permit to engage in the operation of a crematory from the Office:</text> <paragraph num="(1)"> <text>If the individual:</text> <paragraph num="(a)"> <text>Holds a permit or registration under Business Regulation Article, Title 5, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Owns a greater interest in a crematory than a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the person’s ownership interest is equal to the ownership interest in the crematory of a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>If the person who owns the crematory is not:</text> <paragraph num="(a)"> <text>A licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A registrant or permit holder under Business Regulation Article, Title 5, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A permit issued by the Office shall specify whether the crematory is authorized to offer and perform either cremation services, alkaline hydrolysis services, or both.</text> </paragraph> <paragraph num="C."> <text>Board of Morticians and Funeral Directors. A person shall obtain a permit to engage in the operation of a crematory from the Board if the person:</text> <paragraph num="(1)"> <text>Is a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Owns a greater interest in a crematory than a person who holds a permit or registration under Business Regulation Article, Title 5, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before obtaining a permit from the Board, a crematory may cremate or hydrolyze the human remains of one decedent provided the:</text> <paragraph num="(1)"> <text>Cremation or hydrolysis is only performed as part of the manufacturer’s operator training course for the cremation machinery or the hydrolysis unit in which the cremation or hydrolysis takes place; and</text> </paragraph> <paragraph num="(2)"> <text>The person or persons with the right to final disposition of the decedent are notified and have given permission before the cremation or the alkaline hydrolysis occurs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permit — Requirements for Permit."> <paragraph num="A."> <text>Subject to approval of the Board, a person shall receive a permit to operate a crematory in this State if the person meets the permit requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>A person shall:</text> <paragraph num="(1)"> <text>Submit an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the non-refundable application fee and any other applicable fees set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be of good moral character if the applicant is an individual;</text> </paragraph> <paragraph num="(4)"> <text>Designate a registered crematory operator who shall be responsible for the day-to-day operation of the business provided that the registered crematory operator may not be designated as the responsible party for more than a total of two crematories;</text> </paragraph> <paragraph num="(5)"> <text>Provide a certificate of status, issued by the Maryland Department of Assessments and Taxation, if the applicant is a business entity:</text> <paragraph num="(a)"> <text>Indicating that the entity is in good standing, or its equivalent as determined by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Dated not earlier than 30 days before the application; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Comply with all applicable federal, State, and local laws.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An operating crematory shall apply to the Board for a permit within 90 days from the effective date of this regulation or be subject to Board action.</text> </paragraph> <paragraph num="D."> <text>Before applying to the Board for a permit, any crematory not in operation before the effective date of this chapter shall have in its employ an individual who holds a certification from:</text> <paragraph num="(1)"> <text>The Cremation Association of North America (CANA);</text> </paragraph> <paragraph num="(2)"> <text>The International Cemetery, Cremation and Funeral Association (ICCFA); or</text> </paragraph> <paragraph num="(3)"> <text>Another equivalent body recognized jointly by the Board and the Office.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Registration of a Registered Crematory Operator."> <paragraph num="A."> <text>An individual may be registered by the Board as a crematory operator if the individual meets the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>The permit issued by the Board shall specify whether the individual’s training and registration required by this chapter permits the individual to operate a cremator, an alkaline hydrolysis unit, or both.</text> </paragraph> <paragraph num="C."> <text>An individual shall:</text> <paragraph num="(1)"> <text>Submit an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the non-refundable fee and any other applicable fee set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(4)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(5)"> <text>Achieve certification as a crematory operator by the:</text> <paragraph num="(a)"> <text>Cremation Association of North America (CANA);</text> </paragraph> <paragraph num="(b)"> <text>International Cemetery, Cremation and Funeral Association (ICCFA); or</text> </paragraph> <paragraph num="(c)"> <text>Other equivalent certification recognized jointly by the Board and the Office; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>In the crematory with which the applicant is affiliated:</text> <paragraph num="(a)"> <text>Successfully complete the operator training course of the manufacturer of the cremator or the alkaline hydrolysis unit located in the crematory with which the applicant is affiliated; or</text> </paragraph> <paragraph num="(b)"> <text>Provide a notarized letter by the supervising crematory operator for which the individual is employed indicating the completion of training on the cremator or the alkaline hydrolysis unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>To qualify as a trainer, the supervising crematory operator shall have a minimum of 3 years’ experience on the associated cremator or alkaline hydrolysis unit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Change of Information."> <text>The permit holder or registered crematory operator shall notify the Board of any change in the information provided in the application either before or after the issuance of a permit or registration within a reasonable period of time but not to exceed 7 days from the date of the change.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Renewals."> <paragraph num="A."> <text>Before the expiration date of the permit or a registration, a permit holder or a registered crematory operator shall:</text> <paragraph num="(1)"> <text>Complete and return the renewal form;</text> </paragraph> <paragraph num="(2)"> <text>Pay the non-refundable renewal fee set forth in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submit any required documentation to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A person who has a permit or registration as a permit holder or registered crematory operator may renew the permit or registration every 2 years, beginning on a date specified by the Board, in the following manner:</text> <paragraph num="(1)"> <text>Complete the renewal application form;</text> </paragraph> <paragraph num="(2)"> <text>Pay the non-refundable renewal fee set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Meet the permit and registration requirements of this chapter and Health Occupations Article, Title 7, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Submit the required documentation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After the expiration date, if an application for renewal of a permit or registration has not been made or if the individual has been identified by the Office of the Comptroller or the Maryland Department of Labor as delinquent in the payment of taxes or unemployment insurance contributions, pursuant to tax compliance regulations of COMAR 10.31.02 or, pursuant to Family Law Article, §10-119.3, Annotated Code of Maryland, has outstanding child support obligations, the individual may not engage in the operation of a crematory business or act as a registered crematory operator.</text> </paragraph> <paragraph num="D."> <text>An individual who engages in the operation of a crematory business or acts as a registered crematory operator without renewing the required permit or registration is subject to disciplinary action by the Board.</text> </paragraph> <paragraph num="E."> <text>If a permit holder or a registered crematory operator applies for renewal past the expiration date of the permit or registration, the individual shall pay the renewal fee plus the late renewal fee set forth in Regulation .08 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Lapsed Permit."> <text>A person who has been issued a permit and who has allowed the permit to lapse for at least 6 months may apply for a permit by doing the following:</text> <paragraph num="A."> <text>Completing a permit application form;</text> </paragraph> <paragraph num="B."> <text>Paying the permit fee and the late renewal fee set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="C."> <text>Meeting the permit requirements under this chapter;</text> </paragraph> <paragraph num="D."> <text>Submitting the documentation required by this chapter;</text> </paragraph> <paragraph num="E."> <text>Providing a full written explanation to the Board detailing the reasons why the permit was allowed to expire and why a permit is now sought; and</text> </paragraph> <paragraph num="F."> <text>Submitting to the Board an affidavit stating that the person did not engage in the operation of a crematory in this State while the permit was lapsed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Initial permit or registration and renewal fees:</text> <paragraph num="(1)"> <text>Crematory permit — $350;</text> </paragraph> <paragraph num="(2)"> <text>Registered crematory operator — $300;</text> </paragraph> <paragraph num="(3)"> <text>Crematory permit renewal — $350;</text> </paragraph> <paragraph num="(4)"> <text>Registered crematory operator renewal — $300; and</text> </paragraph> <paragraph num="(5)"> <text>Late fee — $200; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Miscellaneous fees:</text> <paragraph num="(1)"> <text>Replacement of permit or registration — $50;</text> </paragraph> <paragraph num="(2)"> <text>Returned check fee — $50;</text> </paragraph> <paragraph num="(3)"> <text>Duplicate permit or registration — $50;</text> </paragraph> <paragraph num="(4)"> <text>Business name change — $50;</text> </paragraph> <paragraph num="(5)"> <text>Personal name change — $50;</text> </paragraph> <paragraph num="(6)"> <text>Business address change — $50; and</text> </paragraph> <paragraph num="(7)"> <text>Annual pre-need sales trust report — $25.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Display of Permit."> <text>A permit and registration, as well as any other permit or license required by local, State, or federal agencies, shall be conspicuously displayed in a public area on the crematory premises.</text> </regulation> <annotations> <annotation type="Authority">Business Regulation Article, §§5-101, 5-204, and 5-303; Health Occupations Article, §§1-213, 7-101, 7-102, 7-205, 7-314—7-316, and 7-319, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2014 (41:7 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted as an emergency provision effective August 28, 2014 (41:19 Md. R. 1075); adopted permanently effective November 10, 2014 (41:22 Md. R. 1319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B, E amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="18" heading="Crematories — Complaints and Disciplinary Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs crematory inspections, standards, the complaint process, investigations, grounds for discipline, and penalties.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Inspection by the Board."> <paragraph num="A."> <text>A crematory shall be available for inspection by a representative of the Board at any time during operating hours.</text> </paragraph> <paragraph num="B."> <text>A crematory shall be inspected:</text> <paragraph num="(1)"> <text>On at least a biennial basis;</text> </paragraph> <paragraph num="(2)"> <text>In furtherance of an investigation; or</text> </paragraph> <paragraph num="(3)"> <text>Upon the sale or change of ownership of the crematory.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The permit holder or any person responsible for day-to-day operation of the cremation machinery or the alkaline hydrolysis unit shall be available to accompany the inspector during the inspection and sign the initial inspection report.</text> </paragraph> <paragraph num="D."> <text>A copy of the inspection report shall be provided to the permit holder or the registered crematory operator responsible for the day-to-day operation of the crematory.</text> </paragraph> <paragraph num="E."> <text>A crematory shall maintain the following minimum standards:</text> <paragraph num="(1)"> <text>The premises shall be maintained in a sanitary manner to comply with Centers for Disease Control’s guidelines on universal precautions;</text> </paragraph> <paragraph num="(2)"> <text>Except by express written consent of the authorizing agents to perform simultaneous, multiple cremations or alkaline hydrolyses, there may not be more than one human body cremated or hydrolyzed simultaneously in a single cremator or alkaline hydrolysis unit at a time;</text> </paragraph> <paragraph num="(3)"> <text>A cremator or an alkaline hydrolysis unit shall be completely cleaned after each cremation or alkaline hydrolysis;</text> </paragraph> <paragraph num="(4)"> <text>There may not be co-mingling of human remains and pet remains in:</text> <paragraph num="(a)"> <text>Refrigeration units;</text> </paragraph> <paragraph num="(b)"> <text>Cremators; or</text> </paragraph> <paragraph num="(c)"> <text>Alkaline hydrolysis units;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Separate cremators or alkaline hydrolysis units shall be dedicated for the cremation or alkaline hydrolysis of human remains and the cremation or alkaline hydrolysis of pets;</text> </paragraph> <paragraph num="(6)"> <text>Except as provided in §E(2) of this regulation, there may not be:</text> <paragraph num="(a)"> <text>Co-mingling mingling of processed human remains with other processed human remains or pet remains;</text> </paragraph> <paragraph num="(b)"> <text>Scooping of processed human remains from a bucket containing co-mingled processed human remains</text> </paragraph> <paragraph num="(c)"> <text>Any form of misrepresentation in the return of processed human remains;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Excluding a deceased person with a known communicable infection, human remains shall be properly identified before cremation or alkaline hydrolysis by verifying that the documentation accompanying the human remains is consistent with a visual observation of the human remains;</text> </paragraph> <paragraph num="(8)"> <text>Burial transit permit shall be an original document pertaining to the deceased;</text> </paragraph> <paragraph num="(9)"> <text>Each crematory shall have:</text> <paragraph num="(a)"> <text>A sink with hot and cold water within the work area housing the crematory equipment; and</text> </paragraph> <paragraph num="(b)"> <text>The tools necessary to thoroughly clean the floor within the work area housing the crematory equipment with water and an appropriate sanitizing agent;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The name of the deceased shall be visible on the outside of the crematory container;</text> </paragraph> <paragraph num="(11)"> <text>Human remains shall be properly stored before cremation or alkaline hydrolysis;</text> </paragraph> <paragraph num="(12)"> <text>Crematories shall:</text> <paragraph num="(a)"> <text>Use only mechanical pulverizing equipment meeting industry standards that has been totally brushed as clean as possible between each use; and</text> </paragraph> <paragraph num="(b)"> <text>Pulverize the processed human remains with a mortar and pestle if the processed human remains are not sufficient in amount for pulverizing in mechanical equipment;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Separate pulverizing drums shall be dedicated for processed human remains and processed pet remains;</text> </paragraph> <paragraph num="(14)"> <text>Processed human remains may not be held pending payment of any fees;</text> </paragraph> <paragraph num="(15)"> <text>Within 6 months of the effective date of these regulations, cremators without safety devices that prevent the automatic door from dropping unintentionally shall be retrofitted with such safety devices;</text> </paragraph> <paragraph num="(16)"> <text>Portable fans may not be used in the area of the cremator;</text> </paragraph> <paragraph num="(17)"> <text>There shall be a minimum of 6 inches between cremator smoke stack and the roof of the crematory;</text> </paragraph> <paragraph num="(18)"> <text>Before pulverizing, the mechanical pulverizer shall be clamped;</text> </paragraph> <paragraph num="(19)"> <text>A cremator shall have visible on its front a warning sign stating, “No leaning past the door of the cremator.”;</text> </paragraph> <paragraph num="(20)"> <text>The permit holder or registered crematory operator shall be present at the crematory during the operation of the:</text> <paragraph num="(a)"> <text>Cremator;</text> </paragraph> <paragraph num="(b)"> <text>Alkaline hydrolysis unit; or</text> </paragraph> <paragraph num="(c)"> <text>Pulverizer; and</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>All individuals:</text> <paragraph num="(a)"> <text>Who operate the cremator or the alkaline hydrolysis unit in a crematory shall be certified by the Cremation Association of North America (CANA), International Cemetery, Cremation, and Funeral Association (ICCFA), or other equivalent certification recognized jointly by the Board and the Office; and</text> </paragraph> <paragraph num="(b)"> <text>Receiving training toward certification to operate a cremator or an alkaline hydrolysis unit shall be allowed to work under the supervision of a registered crematory operator who has the required certification for a period of at least 6 months.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The following completed forms from previous cremations or alkaline hydrolysis shall be available at all times for inspection and copying and are subject to be pulled at random by the inspector:</text> <paragraph num="(1)"> <text>Crematory services authorization form;</text> </paragraph> <paragraph num="(2)"> <text>Burial transit permit;</text> </paragraph> <paragraph num="(3)"> <text>Delegation of authority form;</text> </paragraph> <paragraph num="(4)"> <text>Receipt for human remains;</text> </paragraph> <paragraph num="(5)"> <text>Record of cremation or alkaline hydrolysis;</text> </paragraph> <paragraph num="(6)"> <text>Certificate of cremation or alkaline hydrolysis; and</text> </paragraph> <paragraph num="(7)"> <text>Return of processed human remains certificate.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Inspection results shall be written on forms approved by the Board.</text> </paragraph> <paragraph num="H."> <text>The Board representative performing the inspection shall, on completion of the inspection:</text> <paragraph num="(1)"> <text>Apprise the permit holder of the findings of the inspection; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the permit holder or representative of the permit holder with a copy of the inspection report.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The permit holder or representative of the permit holder shall sign and verify receipt of the inspection report.</text> </paragraph> <paragraph num="J."> <text>At the time of the Board inspection, the permit holder shall provide written documentation to the Board’s inspector that:</text> <paragraph num="(1)"> <text>The crematory equipment has been inspected in accordance with manufacturer specifications;</text> </paragraph> <paragraph num="(2)"> <text>In accordance with manufacturer specifications, it is not time for a manufacturer’s inspection; or</text> </paragraph> <paragraph num="(3)"> <text>The permit holder has requested that the manufacturer conduct an inspection of the crematory equipment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Crematory Inspection Report, Deficiencies, and Penalties."> <paragraph num="A."> <text>The Board shall review the inspection report and make a determination as to whether a deficiency exists.</text> </paragraph> <paragraph num="B."> <text>The Board shall notify the permit holder of the results of the inspection by providing a copy of the inspection report for the permit holder.</text> </paragraph> <paragraph num="C."> <text>If a permit holder passes an inspection, the permit holder shall, prominently and in public view, display on the premises a statement issued by the Board that the crematory has successfully passed an inspection.</text> </paragraph> <paragraph num="D."> <text>If the Board finds a deficiency, the Board shall:</text> <paragraph num="(1)"> <text>Within 7 days, notify the permit holder of the deficiency or failure to pass the inspection; and</text> </paragraph> <paragraph num="(2)"> <text>Provide a copy of the inspection report to the permit holder within 30 days.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Correction of Deficiency.</text> <paragraph num="(1)"> <text>Except as provided in this section, a permit holder shall correct a deficiency within 30 days after receipt of notification or sooner as determined by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board may require immediate correction of a deficiency if the Board considers the correction necessary in the interest of public health.</text> </paragraph> <paragraph num="(3)"> <text>The permit holder may request an extension of time for correction of a deficiency.</text> </paragraph> <paragraph num="(4)"> <text>The Board may approve an extension of time for correction of a deficiency.</text> </paragraph> <paragraph num="(5)"> <text>Upon completion of correction of all deficiencies, the permit holder shall notify the Board.</text> </paragraph> <paragraph num="(6)"> <text>Upon notification from the permit holder, a representative of the Board shall re-inspect the crematory.</text> </paragraph> <paragraph num="(7)"> <text>The Board shall notify the permit holder in writing of the results of the re-inspection by providing a copy of a new inspection report to the permit holder.</text> </paragraph> <paragraph num="(8)"> <text>If re-inspection reveals additional deficiencies not cited in the first report, the permit holder shall correct those deficiencies in the time period specified by the Board unless an extension of time is requested by the permit holder and approved by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Penalties. In the event that a permit holder fails to allow an inspection of the crematory or fails to comply with a notice to correct deficiencies or violations within the time specified, the Board shall:</text> <paragraph num="(1)"> <text>Deem the failure to be a threat to the public health, safety, or welfare and requiring emergency action;</text> </paragraph> <paragraph num="(2)"> <text>Summarily suspend the crematory permit as provided under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Provide notice of the Board’s action to the permit holder; and</text> </paragraph> <paragraph num="(4)"> <text>Provide the permit holder an opportunity to be heard.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Complaints."> <paragraph num="A."> <text>If the permit holder was issued a permit by the Board, a complaint shall be:</text> <paragraph num="(1)"> <text>Filed in compliance with the provisions of COMAR 10.29.11.03; and</text> </paragraph> <paragraph num="(2)"> <text>Processed in accordance with the provisions of COMAR 10.29.11.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may initiate a complaint or investigation on its own.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Investigations."> <text>The Board and the Office of Cemetery Oversight may share investigative information and conduct joint investigations.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Grounds for Discipline, Hearing, and Penalties."> <paragraph num="A."> <text>Pursuant to the provisions of Health Occupations Article, §§7-316 and 7-319, Annotated Code of Maryland, the Board may:</text> <paragraph num="(1)"> <text>Deny an applicant:</text> <paragraph num="(a)"> <text>A crematory permit; or</text> </paragraph> <paragraph num="(b)"> <text>A crematory operator registration;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Reprimand any:</text> <paragraph num="(a)"> <text>Permit holder; or</text> </paragraph> <paragraph num="(b)"> <text>Registered crematory operator; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Suspend or revoke:</text> <paragraph num="(a)"> <text>A crematory permit; or</text> </paragraph> <paragraph num="(b)"> <text>A crematory operator registration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Pursuant to the provisions of Health Occupations Article, §7-317, Annotated Code of Maryland, if the Board, after bringing an action, finds that there are grounds for probation, suspension, or revocation, the Board may impose a penalty not exceeding $5,000.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§5-502—5-504, 5-508, and 5-511—5-514; Health Occupations Article, §§7-101, 7-102, 7-205, 7-316, 7-317, 7-319, and 7-406, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2014 (41:7 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, E amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="19" heading="Crematories — Crematory Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the procedures to be followed in performing a cremation or alkaline hydrolysis in this State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Removal, Identification, and Transportation of Human Remains."> <paragraph num="A."> <text>Upon receipt of human remains, a permit holder in the presence of the authorizing agent or representative of the funeral establishment engaging crematory services shall:</text> <paragraph num="(1)"> <text>Verify that the information on the wrist tag is consistent with the:</text> <paragraph num="(a)"> <text>Documentation accompanying the deceased; and</text> </paragraph> <paragraph num="(b)"> <text>Visual observation of the remains themselves;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Use a metal detector wand to inspect for the presence of any battery operated, implanted devices including pacemakers, defibrillators, or pain relief devices;</text> </paragraph> <paragraph num="(3)"> <text>Refuse to accept human remains for cremation if an inspection of the human remains indicates the presence of any battery operated, implanted device;</text> </paragraph> <paragraph num="(4)"> <text>Ensure the removal and properly dispose of any hazardous object or any other materials that the individual authorized under this subtitle deems should be removed from the human remains, the crematory container, or the hydrolysis container, in order to prevent harm to the public health or damage to the cremator or alkaline hydrolysis unit;</text> </paragraph> <paragraph num="(5)"> <text>Remove any jewelry:</text> <paragraph num="(a)"> <text>On the human remains;</text> </paragraph> <paragraph num="(b)"> <text>In the crematory container; or</text> </paragraph> <paragraph num="(c)"> <text>In the hydrolysis container;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Return any removed jewelry to the authorizing agent or representative of the funeral establishment engaging crematory services; and</text> </paragraph> <paragraph num="(7)"> <text>Obtain a signed, itemized receipt from the authorizing agent or representative of the funeral establishment engaging crematory services for the removed jewelry and retain the receipt as a permanent record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Foreign objects removed from the human remains:</text> <paragraph num="(1)"> <text>Shall be treated as medical waste and disposed of accordingly; and</text> </paragraph> <paragraph num="(2)"> <text>May not be donated until a sterilization process through a third party recognized by the Board to dispose properly of medical waste has been performed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Materials identifying the human remains that are placed in the custody of a permit holder shall contain the following information about the decedent:</text> <paragraph num="(1)"> <text>Name;</text> </paragraph> <paragraph num="(2)"> <text>Date of birth;</text> </paragraph> <paragraph num="(3)"> <text>Date of death;</text> </paragraph> <paragraph num="(4)"> <text>Name of funeral establishment or authorizing agent;</text> </paragraph> <paragraph num="(5)"> <text>Gender; and</text> </paragraph> <paragraph num="(6)"> <text>Name and relationship of authorizing agent to deceased.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A permit holder may not accept unidentified human remains for cremation or alkaline hydrolysis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Crematory and Hydrolysis Containers."> <paragraph num="A."> <text>A crematory container:</text> <paragraph num="(1)"> <text>Shall be a readily combustible, rigid container suitable for cremation;</text> </paragraph> <paragraph num="(2)"> <text>Shall provide a completely enclosed covering for the human remains;</text> </paragraph> <paragraph num="(3)"> <text>Shall be resistant to leakage or spillage;</text> </paragraph> <paragraph num="(4)"> <text>Shall be of sufficient strength and rigidity for ease of handling;</text> </paragraph> <paragraph num="(5)"> <text>Shall provide protection to the health and safety of crematory establishment personnel and the public;</text> </paragraph> <paragraph num="(6)"> <text>Shall comply with all local, State, and federal governmental emissions regulations;</text> </paragraph> <paragraph num="(7)"> <text>May not be composed of metal or polyethylene material; and</text> </paragraph> <paragraph num="(8)"> <text>Which appears to be heavily coated with varnish, lacquer, or any other highly combustible substance, shall be:</text> <paragraph num="(a)"> <text>Placed in a cold cremator; or</text> </paragraph> <paragraph num="(b)"> <text>Coated completely with water before being placed in the cremator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An alkaline hydrolysis container:</text> <paragraph num="(1)"> <text>Shall consist of a completely enclosed covering for the human remains;</text> </paragraph> <paragraph num="(2)"> <text>Shall be resistant to leakage or spillage;</text> </paragraph> <paragraph num="(3)"> <text>Shall provide protection to the health and safety of the crematory establishment personnel and the public;</text> </paragraph> <paragraph num="(4)"> <text>Shall comply with all local, State, and federal emissions regulations; and</text> </paragraph> <paragraph num="(5)"> <text>Once inside the alkaline hydrolysis unit, may be removed prior to the start of the alkaline hydrolysis process as long as the human remains are covered to protect the dignity of the decedent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Holding Facilities."> <text>A holding facility shall:</text> <paragraph num="A."> <text>Comply with applicable public health laws;</text> </paragraph> <paragraph num="B."> <text>Preserve the dignity of human remains;</text> </paragraph> <paragraph num="C."> <text>Recognize the integrity, health, and safety of crematory establishment personnel; and</text> </paragraph> <paragraph num="D."> <text>Be secure from access by unauthorized persons.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Holding Remains."> <paragraph num="A."> <text>Unless prevented by emergency circumstances, human remains that have been designated for cremation or alkaline hydrolysis shall be cremated or hydrolyzed by a permit holder within 48 hours after receipt.</text> </paragraph> <paragraph num="B."> <text>A permit holder may not hold human remains for cremation or alkaline hydrolysis unless the human remains are contained within an individual, closed cremation or hydrolysis container as required under Regulation .03 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A permit holder may not accept a cremation or alkaline hydrolysis container from which there is any evidence of leakage of the body fluids from the human remains therein.</text> </paragraph> <paragraph num="D."> <text>Whenever a permit holder is unable to cremate or hydrolyze human remains within 48 hours of taking custody thereof due to emergency circumstances, the permit holder shall maintain the human remains in a refrigerated holding facility, either on or off site, at 40°F or less, unless the remains have been embalmed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Identification of Human Remains Immediately Before Cremation or Alkaline Hydrolysis."> <paragraph num="A."> <text>Immediately before being placed within the cremator or the alkaline hydrolysis unit, the individual authorized under this subtitle shall:</text> <paragraph num="(1)"> <text>Verify the identification of the human remains; and</text> </paragraph> <paragraph num="(2)"> <text>Place in or on the cremator or the alkaline hydrolysis unit the hard metal or plastic identification disc of the human remains being processed where it shall remain in place until the cremation or the alkaline hydrolysis process is complete.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The permit holder’s designee may not leave the:</text> <paragraph num="(1)"> <text>Immediate area of the cremator during the cremation process; or</text> </paragraph> <paragraph num="(2)"> <text>Facility for the alkaline hydrolysis unit during the alkaline hydrolysis process.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The alkaline hydrolysis unit shall be monitored at all times during the alkaline hydrolysis process.</text> </paragraph> <paragraph num="D."> <text>Records.</text> <paragraph num="(1)"> <text>The permit holder shall maintain the written authorizations required by Regulation .08 of this chapter as required pursuant to Health-General Article, §4-304, Annotated Code of Maryland, and COMAR 10.01.16.04B.</text> </paragraph> <paragraph num="(2)"> <text>The records are subject to inspection and copying by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Crematory Services Authorization."> <paragraph num="A."> <text>Except as otherwise provided in COMAR 10.29.18.02, a permit holder may not cremate or hydrolyze human remains until:</text> <paragraph num="(1)"> <text>The body has been identified as required under Health Occupation Article, §7-411, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The permit holder crematory has received:</text> <paragraph num="(a)"> <text>A crematory services authorization on a form approved by the Board and signed by an authorizing agent;</text> </paragraph> <paragraph num="(b)"> <text>If applicable, a written delegation document or facsimile; and</text> </paragraph> <paragraph num="(c)"> <text>Any other documentation required by federal, State, or local law; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The permit holder has documented that at least 12 hours have elapsed from the time of death of the individual prior to beginning cremation or alkaline hydrolysis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The crematory services authorization form shall:</text> <paragraph num="(1)"> <text>Be provided by the permit holder to the authorizing agent;</text> </paragraph> <paragraph num="(2)"> <text>Contain the following information:</text> <paragraph num="(a)"> <text>The identity of the decedent;</text> </paragraph> <paragraph num="(b)"> <text>Date of death;</text> </paragraph> <paragraph num="(c)"> <text>The name and address of the authorizing agent and the relationship between the authorizing agent and the deceased;</text> </paragraph> <paragraph num="(d)"> <text>Authorization for the permit holder to cremate or hydrolyze the human remains;</text> </paragraph> <paragraph num="(e)"> <text>An indication of whether the decedent is:</text> <paragraph num="(i)"> <text>A veteran, as defined in State Government Article, § 9-901, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>An eligible dependent of a veteran, as defined in Business Regulation Article, §5-803, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Authorization to verify that the following have been removed before cremation or alkaline hydrolysis:</text> <paragraph num="(i)"> <text>An implanted pacemaker or defibrillator; and</text> </paragraph> <paragraph num="(ii)"> <text>Any other materials that should be removed to prevent harm to the public health or damage to equipment;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A representation by the authorizing agent that radiologic implant treatment has not occurred within 5 days before cremation or alkaline hydrolysis;</text> </paragraph> <paragraph num="(h)"> <text>A representation that the authorizing agent is aware of no objection to the human remains being processed by any person who has a right to control the disposition of the human remains;</text> </paragraph> <paragraph num="(i)"> <text>The name and address of the person authorized to claim the processed human remains from the permit holder or to accept the processed remains via registered mail; and</text> </paragraph> <paragraph num="(j)"> <text>The name and address of the crematory to which the authorizing agent has given permission; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be signed by the authorizing agent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an authorizing agent is not readily available to execute the crematory services authorization form, the authorizing agent may transmit the document in writing with notary seal electronically:</text> <paragraph num="(1)"> <text>In writing; or</text> </paragraph> <paragraph num="(2)"> <text>If located outside the area, by transmitting to the permit holder:</text> <paragraph num="(a)"> <text>A signed statement electronically or by facsimile that contains the name, address, and relationship of the sender to the decedent and the name and address of the individual to whom authority is delegated; and</text> </paragraph> <paragraph num="(b)"> <text>Once the authorizing agent is located in the area, a notarized document through U.S. Postal Service attesting to the delegation of authority.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Upon receipt of the written delegation document or a copy transmitted electronically or by facsimile, the permit holder shall allow the named individual to serve as the authorizing agent. The documents shall be signed by the authorizing agent in the presence of a notary.</text> </paragraph> <paragraph num="E."> <text>A person signing a crematory services authorization form is deemed to warrant the truthfulness of any facts set forth in the crematory services authorization form, including the identity of the deceased whose remains are sought to be processed and the authority of that person to order such a cremation or alkaline hydrolysis.</text> </paragraph> <paragraph num="F."> <text>A permit holder shall notify and obtain written consent of the authorizing agent before the cremation or the alkaline hydrolysis of human remains at a location other than the location named on the crematory services authorization form.</text> </paragraph> <paragraph num="G."> <text>A permit holder shall maintain a copy of every crematory services authorization form required under this regulation as permanent records.</text> </paragraph> <paragraph num="H."> <text>Crematory services authorization records are subject to inspection and copying by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Record of Receipt of Remains."> <paragraph num="A."> <text>A permit holder shall provide to an individual who delivers human remains for cremation or alkaline hydrolysis a receipt signed by both the permit holder authority and the individual who delivered the human remains, that includes the:</text> <paragraph num="(1)"> <text>Name of the individual from whom the human remains were received and the name of the individual’s employer, if any;</text> </paragraph> <paragraph num="(2)"> <text>Name and address of the crematory;</text> </paragraph> <paragraph num="(3)"> <text>Name of the deceased;</text> </paragraph> <paragraph num="(4)"> <text>Gender of the deceased;</text> </paragraph> <paragraph num="(5)"> <text>Date of death of the deceased; and</text> </paragraph> <paragraph num="(6)"> <text>Verification of the authorized burial transit permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The permit holder shall maintain a record of each cremation or alkaline hydrolysis, which shall include the:</text> <paragraph num="(1)"> <text>Name of the decedent;</text> </paragraph> <paragraph num="(2)"> <text>Date of birth of the decedent;</text> </paragraph> <paragraph num="(3)"> <text>Gender of the decedent;</text> </paragraph> <paragraph num="(4)"> <text>Date of death;</text> </paragraph> <paragraph num="(5)"> <text>Name and address of the authorizing agent;</text> </paragraph> <paragraph num="(6)"> <text>Date, time, and location of cremation or alkaline hydrolysis; and</text> </paragraph> <paragraph num="(7)"> <text>Name of the individual who performed the cremation or the alkaline hydrolysis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The permit holder shall provide a certificate of disposition of processed human remains to the authorizing agent or funeral establishment that arranged for the cremation or the alkaline hydrolysis that includes the:</text> <paragraph num="(1)"> <text>Name of the decedent;</text> </paragraph> <paragraph num="(2)"> <text>Name of the authorizing agent;</text> </paragraph> <paragraph num="(3)"> <text>Name and address of the person who received the processed human remains from the permit holder; and</text> </paragraph> <paragraph num="(4)"> <text>If ascertainable:</text> <paragraph num="(a)"> <text>The location, including the name of the cemetery and plot location if the remains are interred; and</text> </paragraph> <paragraph num="(b)"> <text>The manner and date of the disposition of the processed human remains.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The permit holder shall maintain a copy of every record and receipt required by this chapter as permanent records.</text> </paragraph> <paragraph num="E."> <text>All records and receipts required by this chapter are subject to inspection and copying by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Use of a Casket; Embalming."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a permit holder may not:</text> <paragraph num="(1)"> <text>Require that human remains be placed in a casket before cremation or that human remains be cremated in a casket;</text> </paragraph> <paragraph num="(2)"> <text>Refuse to accept human remains for cremation because the remains are not in a casket; or</text> </paragraph> <paragraph num="(3)"> <text>Refuse to accept human remains for cremation because the remains are in a suitable, combustible wooden casket, but may require the authorizing agent or funeral establishment engaging the services of the crematory authority to remove the metal mattress holder in the casket.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Human remains delivered to a crematory establishment may not be removed from the cremation container.</text> </paragraph> <paragraph num="C."> <text>The cremation container shall be cremated with the human remains unless the authorizing agent for the deceased requests a more natural environment for the deceased. A permit holder is not required to accept this manner of disposition.</text> </paragraph> <paragraph num="D."> <text>A permit holder may not require that human remains be subjected to embalming before cremation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Disposition of Processed Human Remains."> <paragraph num="A."> <text>On completion of the cremation or the alkaline hydrolysis, insofar as is possible:</text> <paragraph num="(1)"> <text>All of the recoverable residue of the cremation or the alkaline hydrolysis process shall be:</text> <paragraph num="(a)"> <text>Removed from the cremator or the alkaline hydrolysis unit;</text> </paragraph> <paragraph num="(b)"> <text>Except for medical devices remaining after cremation or alkaline hydrolysis, pulverized; and</text> </paragraph> <paragraph num="(c)"> <text>Placed in a sealable container; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The identification disc required by Health Occupations Article, §7-411, Annotated Code of Maryland, shall be:</text> <paragraph num="(a)"> <text>Removed from the cremator or the alkaline hydrolysis unit; and</text> </paragraph> <paragraph num="(b)"> <text>Placed in the sealable container with the processed human remains.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Medical devices which remain after the completion of the cremation or the alkaline hydrolysis process shall be treated as medical waste and disposed of accordingly.</text> </paragraph> <paragraph num="C."> <text>After pulverization, all of the processed human remains, together with the identification disc, shall be placed in a sealable container.</text> </paragraph> <paragraph num="D."> <text>If the sealable container opening is not of adequate dimensions to accommodate a disc, it shall be affixed to the exterior of the sealable container and a record of the cremation number shall be placed in the sealable container.</text> </paragraph> <paragraph num="E."> <text>If all of the processed human remains and the identification disc will not fit within the dimensions of a sealable container, the remainder of the remains shall be returned to the authorizing agent, or the agent’s representative, in a separate, sealable container. Container seams shall be taped.</text> </paragraph> <paragraph num="F."> <text>If the processed human remains and identification disc do not adequately fill the container’s interior dimensions, the extra space may be filled with packing material that will not become intermingled with the remains and then securely closed.</text> </paragraph> <paragraph num="G."> <text>If a sealable container is to be shipped, it shall:</text> <paragraph num="(1)"> <text>Be placed within a separate sturdy box with all box seams securely taped closed; and</text> </paragraph> <paragraph num="(2)"> <text>Have the name of the deceased person whose processed remains are contained therein clearly identified on the outside of the container.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If processed human remains have been in the possession of a permit holder, as originally authorized by the authorizing agent without instructions for disposition for a period of 10 days or more from the date of cremation or alkaline hydrolysis, the permit holder may send the processed human remains, using the current mailing standard approved by the U.S. Postal Service, return receipt requested, to the authorizing agent.</text> </paragraph> <paragraph num="I."> <text>Veteran and Eligible Dependent Decedents.</text> <paragraph num="(1)"> <text>Unless the authorizing agent directs otherwise, if a permit holder in possession of processed remains of a decedent veteran or a decedent eligible dependent, the permit holder shall provide the decedent’s identifying information to a veterans service organization, as defined in Business Regulation Article, §5-803, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The veterans service organization will notify the permit holder whether the decedent is a veteran or an eligible dependent eligible for burial in a veterans cemetery.</text> </paragraph> <paragraph num="(3)"> <text>If the unclaimed processed remains are those of a veteran or an eligible dependent, the permit holder may transfer the processed remains to a veterans service organization for the purpose of disposition of the processed remains.</text> </paragraph> <paragraph num="(4)"> <text>If a veterans service organization does not take possession of unclaimed processed remains that qualify for a plot in a State veterans cemetery under State Government Article, §9-906, Annotated Code of Maryland, within 10 days after the permit holder receives the notification required in this regulation, the permit holder shall:</text> <paragraph num="(a)"> <text>Notify the Department of Veterans and Military Families of the status of the processed remains for the purpose of the appropriate disposition of the processed remains; and</text> </paragraph> <paragraph num="(b)"> <text>Transfer the processed remains to the Department of Veterans and Military Families for the purpose of the appropriate disposition of the processed remains.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Tools."> <paragraph num="A."> <text>A crematory offering cremation shall maintain, at its own expense, the following tool inventory:</text> <paragraph num="(1)"> <text>Safety placement tool measuring a minimum of 49 inches in length;</text> </paragraph> <paragraph num="(2)"> <text>Wire brushes for cleaning cremators;</text> </paragraph> <paragraph num="(3)"> <text>Brush with fine bristles for cleaning pulverizers;</text> </paragraph> <paragraph num="(4)"> <text>Mortar and pestle;</text> </paragraph> <paragraph num="(5)"> <text>Funnel;</text> </paragraph> <paragraph num="(6)"> <text>High temperature protective gloves and heat-resistant leather gloves;</text> </paragraph> <paragraph num="(7)"> <text>Hand magnet and metal detector wand to detect and remove metal from cremated human remains;</text> </paragraph> <paragraph num="(8)"> <text>Tweezers to remove nonmetal objects from cremated human remains; and</text> </paragraph> <paragraph num="(9)"> <text>National Institute for Occupational Safety and Health certified N95 filtering facepiece respirators.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A crematory offering alkaline hydrolysis shall maintain, at its own expense, the following tool inventory:</text> <paragraph num="(1)"> <text>Suitable tools for cleaning the alkaline hydrolysis unit;</text> </paragraph> <paragraph num="(2)"> <text>Brush with fine bristles for cleaning pulverizers;</text> </paragraph> <paragraph num="(3)"> <text>Mortar and pestle;</text> </paragraph> <paragraph num="(4)"> <text>Funnel;</text> </paragraph> <paragraph num="(5)"> <text>Hand magnet and metal detector wand to detect and remove metal from hydrolyzed human remains;</text> </paragraph> <paragraph num="(6)"> <text>Tweezers to remove nonmetal objects from hydrolyzed human remains;</text> </paragraph> <paragraph num="(7)"> <text>National Institute for Occupational Safety and Health certified N95 filtering facepiece respirators; and</text> </paragraph> <paragraph num="(8)"> <text>An emergency shower and eyewash combination unit meeting the criteria established under the American National Standards Institute and the International Safety Equipment Association Z358.1-2014 (R2020) or its successor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Visitors."> <paragraph num="A."> <text>The permit holder or the designated crematory operator shall:</text> <paragraph num="(1)"> <text>Submit to the Board the number of persons not affiliated with the operations of the crematory who can safely be within the same room and within 10 feet of the cremator door or the alkaline hydrolysis unit; and</text> </paragraph> <paragraph num="(2)"> <text>Verify to the Board that the permit holder has submitted the information required in §A(1) of this regulation to their liability insurance carrier.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Crematories that begin operation after July 1, 2014, shall construct a viewing room in the area of the cremator if the crematory intends to have more than two visitors present in the area of the cremator during the cremation.</text> </paragraph> <paragraph num="C."> <text>Crematories providing alkaline hydrolysis shall construct a viewing room in the area of the alkaline hydrolysis unit if the crematory intends to have more than two visitors present in the area of the alkaline hydrolysis unit during the alkaline hydrolysis.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§5-502—5-504, 5-508, and 5-511—5-514; Health Occupations Article, §§7-101, 7-102, and 7-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2014 (41:7 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="20" heading="Crematories — Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs any person who holds a permit to:</text> <paragraph num="A."> <text>Engage in the operation of a crematory;</text> </paragraph> <paragraph num="B."> <text>Act as a designated crematory operator;or</text> </paragraph> <paragraph num="C."> <text>Act as a registered crematory operator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="General Professional Practices."> <paragraph num="A."> <text>A permit holder or registered crematory operator shall:</text> <paragraph num="(1)"> <text>Act in a manner that respects and protects the dignity of a decedent and the decedent’s family;</text> </paragraph> <paragraph num="(2)"> <text>Conduct business in a reasonable, usual, and customary manner avoiding unfair trade practices;</text> </paragraph> <paragraph num="(3)"> <text>Comply with the State public health laws as set forth in Health-General Article, §§4-215 and 5-501, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Comply with the Maryland Morticians and Funeral Directors Act, Health Occupations Article, Title 7, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Implement and follow through on all arrangements agreed on between consumer and the crematory;</text> </paragraph> <paragraph num="(6)"> <text>Provide appropriate services for and respect the rights of individuals without regard to age, race, creed, national origin, gender, disability, marital status, political belief, religious affiliation, social or economic status, or social preferences;</text> </paragraph> <paragraph num="(7)"> <text>Comply with all local, State, and federal laws regarding the final disposition of human remains;</text> </paragraph> <paragraph num="(8)"> <text>Be sensitive and responsive to the bereavement needs of a decedent’s family; and</text> </paragraph> <paragraph num="(9)"> <text>Provide a general price list in effect at that time in accordance with the Federal Trade Commission’s funeral rule, 16 CFR part 453.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In advertising, a licensee may not include statements:</text> <paragraph num="(1)"> <text>That are misrepresentations of facts;</text> </paragraph> <paragraph num="(2)"> <text>That are likely to mislead or deceive because, in context, the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to a consumer; or</text> </paragraph> <paragraph num="(4)"> <text>Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent individual to misunderstand or be deceived.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A permit holder or crematory operator may not:</text> <paragraph num="(1)"> <text>Use, or participate in the use of, any form of communication to consumers containing a false, fraudulent, misleading, deceptive, or unfair statement or claim; or</text> </paragraph> <paragraph num="(2)"> <text>Operate a crematory, or perform a cremation or alkaline hydrolysis while under the influence of alcohol, an illegal drug, or a controlled dangerous substance, without the prescription of a physician.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §7-101, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2014 (41:7 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> <chapter num="21" heading="Mortuary Transport Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>Applicants for a mortuary transport service permit;</text> </paragraph> <paragraph num="B."> <text>Applicants for registration as a transporter for a mortuary transport service;</text> </paragraph> <paragraph num="C."> <text>Permitted mortuary transport services; and</text> </paragraph> <paragraph num="D."> <text>Registered transporters.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Morticians and Funeral Directors.</text> </paragraph> <paragraph num="(2)"> <text>“CJIS” means the Criminal Justice Information System.</text> </paragraph> <paragraph num="(3)"> <text>“Cleaning” means to disinfect the entire interior of the mortuary transport service vehicle, including the drivers’ cabin.</text> </paragraph> <paragraph num="(4)"> <text>“Crematory” means a building, portion of a building, or structure that houses the necessary appliances and facilities for cremation.</text> </paragraph> <paragraph num="(5)"> <text>“Criminal history records check” means the performance of both a:</text> <paragraph num="(a)"> <text>State criminal history check by the Central Repository; and</text> </paragraph> <paragraph num="(b)"> <text>National criminal history check by the Federal Bureau of Investigation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Disinfect” means a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects using liquid chemicals or wet pasteurization.</text> </paragraph> <paragraph num="(7)"> <text>“Funeral establishment” means any building, structure, or premises from which the business of practicing mortuary science is conducted.</text> </paragraph> <paragraph num="(8)"> <text>Human Remains.</text> <paragraph num="(a)"> <text>“Human remains” means:</text> <paragraph num="(i)"> <text>The body of a deceased person; or</text> </paragraph> <paragraph num="(ii)"> <text>A part of a body or limb that has been removed from a living person.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Human remains” includes the body or part of a body or limb in any state of decomposition.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Impervious surface” means a surface constructed from material that does not allow another substance to pass through or to penetrate the material.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed funeral establishment” means, unless the context requires otherwise, a funeral establishment that is licensed by the Board.</text> </paragraph> <paragraph num="(11)"> <text>Mortuary Transport Service.</text> <paragraph num="(a)"> <text>“Mortuary transport service” means an individual or a business entity issued a permit by the Board that, for compensation:</text> <paragraph num="(i)"> <text>Removes and transports human remains;</text> </paragraph> <paragraph num="(ii)"> <text>Transports human remains from the place of death or storage to a funeral establishment or crematory; or</text> </paragraph> <paragraph num="(iii)"> <text>Employs a transporter to remove or transport human remains.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Mortuary transport service” does not include:</text> <paragraph num="(i)"> <text>A licensed funeral establishment using the establishment's own employee or employees to remove and transport human remains for compensation in the establishment's own Board-inspected vehicle; or</text> </paragraph> <paragraph num="(ii)"> <text>A cemetery or an employee of a cemetery that removes or transports human remains within the boundaries of the cemetery.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Office” means the Office of Cemetery Oversight within the Maryland Department of Labor.</text> </paragraph> <paragraph num="(13)"> <text>“Permit” means a permit issued by the Board to the owner of a mortuary transport service to operate in the State.</text> </paragraph> <paragraph num="(14)"> <text>“Permit holder” means a mortuary transport service that holds a permit issued by the Board.</text> </paragraph> <paragraph num="(15)"> <text>“Registered transporter” means an individual employee of a mortuary transport service who has registered with the Board to remove and transport human remains.</text> </paragraph> <paragraph num="(16)"> <text>“Registration” means a registration issued by the Board to a registered transporter to remove and transport human remains.</text> </paragraph> <paragraph num="(17)"> <text>“Removal vehicle” means a vehicle of a size, dimensions, and specifications suitable for the transportation of human remains which has passed an inspection by the Board.</text> </paragraph> <paragraph num="(18)"> <text>“Remove and transport human remains” means to remove human remains from one location and transport the human remains directly to another location.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for a Permit."> <paragraph num="A."> <text>To qualify for a permit to operate a mortuary transport service, an individual shall:</text> <paragraph num="(1)"> <text>Be at least 18 years of age;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(3)"> <text>Satisfy the requirements of Health Occupations Article, §7-602(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To apply for a permit, an individual shall submit to the Board:</text> <paragraph num="(1)"> <text>An application signed by an individual who is the owner or co-owner of the mortuary transport service to be permitted on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The required fee as set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>A notarized statement attesting to compliance with Health Occupations Article, §7-602(c), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Evidence that all removal vehicles have passed an inspection by an inspector designated by the Board; and</text> </paragraph> <paragraph num="(5)"> <text>Evidence that the mortuary transport service is bondable and carries liability insurance to cover each registered transporter employed by the mortuary transport service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A individual may not operate a mortuary transport service in the State without a permit issued by the Board.</text> </paragraph> <paragraph num="D."> <text>If the permit holder is the sole employee of the mortuary transport service, the permit holder shall also be registered as a transporter.</text> </paragraph> <paragraph num="E."> <text>The permit holder shall return an expired permit to the Board as soon as possible.</text> </paragraph> <paragraph num="F."> <text>The permit holder shall be responsible for registering all transporters in their employ.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Registration."> <paragraph num="A."> <text>To qualify as a registered transporter, an individual shall:</text> <paragraph num="(1)"> <text>Be at least 18 years of age;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Hold a current valid driver’s license in good standing; and</text> </paragraph> <paragraph num="(4)"> <text>Be employed by a mortuary transport service that holds a permit issued by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Required Coursework. Before registering as a registered transporter, an individual shall complete the following Board approved coursework options:</text> <paragraph num="(1)"> <text>An OSHA or MOSHA training course;</text> </paragraph> <paragraph num="(2)"> <text>A course on blood-borne pathogens;</text> </paragraph> <paragraph num="(3)"> <text>A course on infection control; and</text> </paragraph> <paragraph num="(4)"> <text>A law course on:</text> <paragraph num="(a)"> <text>Health-General Article, §5-513, Annotated Code of Maryland, excluding references to inspections of an out-of-State facility, with the objective of understanding the proper treatment of remains with dignity; and</text> </paragraph> <paragraph num="(b)"> <text>This chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To apply for a registration as a registered transporter, an individual shall submit:</text> <paragraph num="(1)"> <text>A signed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Written, verified evidence satisfactory to the Board that the applicant has:</text> <paragraph num="(a)"> <text>Completed the application for a criminal history records check using the process required by CJIS and designating that the check be sent to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Paid all fees required by CJIS;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Evidence of successful completion of the coursework required by §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>A copy of the individual's driving record, including probation before judgment findings.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A registered transporter shall maintain a current mailing address, excluding a post office box address, on file with the Board.</text> </paragraph> <paragraph num="E."> <text>The permit of the mortuary transport service that employs the registered transporter shall be prominently displayed on the person of the registered transporter by means of an identification card. The identification card shall include the following information:</text> <paragraph num="(1)"> <text>A current picture of the registered transporter;</text> </paragraph> <paragraph num="(2)"> <text>The name of the mortuary transport service that employs the registered transporter; and</text> </paragraph> <paragraph num="(3)"> <text>The permit number of the mortuary transport service.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The permit holder shall confiscate the identification card of a transporter who is no longer in the permit holder’s employ and return the identification card to the Board.</text> </paragraph> <paragraph num="G."> <text>The Board may not register an applicant until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the completed application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Procedures."> <paragraph num="A."> <text>Before using a body bag for removal of human remains, the registered transporter shall inspect the body bag to ensure that the body bag is fully closeable and that there are no holes, rips, or tears in the body bag.</text> </paragraph> <paragraph num="B."> <text>Potentially Infectious Body Fluids.</text> <paragraph num="(1)"> <text>All bodily fluids shall be considered as potentially infectious and dealt with appropriately.</text> </paragraph> <paragraph num="(2)"> <text>Proper personal protective equipment shall be available for use at all times.</text> </paragraph> <paragraph num="(3)"> <text>Contaminated surfaces and equipment shall be cleaned with disinfectant immediately upon completion of the removal or as soon as possible after the removal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After each removal and as soon as possible, the registered transporter shall clean their hands using antiseptic hand cleanser and paper towels or antiseptic towelettes. As soon as possible thereafter, the registered transporter shall wash their hands using hot running water and soap.</text> </paragraph> <paragraph num="D."> <text>The permit holder shall establish a written schedule for thorough cleaning, to be kept in the glove box of the removal vehicle, and method for cleaning the removal vehicle and equipment at least quarterly or as needed taking into account the use of the vehicle, the type of contamination present, and the human remains transferred.</text> </paragraph> <paragraph num="E."> <text>An individual authorizing removal shall be given an inventory in which the transporter has made note of all valuables found on the decedent for the individual’s signature.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prohibited Acts."> <paragraph num="A."> <text>A permit holder or transporter shall:</text> <paragraph num="(1)"> <text>At all times treat the human remains being transported with the utmost dignity; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with the requirements of Health-General Article, §5-513, Annotated Code of Maryland, except with regard to inspection of an out-of-State facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A permit holder may not:</text> <paragraph num="(1)"> <text>Violate any federal, State, or local law or regulation or order a transporter to violate any federal, State, or local law or regulation;</text> </paragraph> <paragraph num="(2)"> <text>Employ a transporter who does not hold a registration issued by the Board;</text> </paragraph> <paragraph num="(3)"> <text>In signage or advertisement, use a name for the mortuary transport service that is different from the name of the mortuary transport service as it appears on the permit issued by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Operate the mortuary transport service in a manner that does not respect:</text> <paragraph num="(a)"> <text>The dignity of the decedent; and</text> </paragraph> <paragraph num="(b)"> <text>The public health;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Prevent or in any way inhibit the Board’s designated inspector from investigating a complaint or from inspecting a removal vehicle;</text> </paragraph> <paragraph num="(6)"> <text>Unless appropriately licensed, represent themselves as a mortician or funeral director;</text> </paragraph> <paragraph num="(7)"> <text>Make arrangements for burial or cremation of human remains;</text> </paragraph> <paragraph num="(8)"> <text>Fail to notify the Board within 30 days of:</text> <paragraph num="(a)"> <text>A change in address of the mortuary transport service;</text> </paragraph> <paragraph num="(b)"> <text>A change in address of a registered transporter; or</text> </paragraph> <paragraph num="(c)"> <text>A commencement of employment or a separation of employment with a registered transporter;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Dress or behave in an unprofessional manner while performing their official duties;</text> </paragraph> <paragraph num="(10)"> <text>Advertise or solicit business directly to the family of a dying person or recently deceased person; or</text> </paragraph> <paragraph num="(11)"> <text>Offer goods or services other than the service a permit authorizes the permit holder to provide.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A registered transporter may not:</text> <paragraph num="(1)"> <text>Transport human remains without the required documented authorization;</text> </paragraph> <paragraph num="(2)"> <text>Unless appropriately credentialed, represent themselves as a:</text> <paragraph num="(a)"> <text>Permit holder;</text> </paragraph> <paragraph num="(b)"> <text>Mortician; or</text> </paragraph> <paragraph num="(c)"> <text>Funeral director;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Allow an individual who is not an employee of the employing mortuary transport service or of the funeral establishment engaging the services of the mortuary transport service to accompany the registered transporter while in the performance of the registered transporter’s official duties;</text> </paragraph> <paragraph num="(4)"> <text>Make arrangements for burial or cremation of the human remains unless appropriately licensed or certified by the Board or the Office;</text> </paragraph> <paragraph num="(5)"> <text>Unless removing and transporting more than one human remains from different locations, fail to transport the human remains directly to the location agreed upon by the individual with the right to final disposition of the human remains or to the location requested by the mortician or funeral director;</text> </paragraph> <paragraph num="(6)"> <text>Fail to notify the Board of a change of the registered transporter’s address within 30 days;</text> </paragraph> <paragraph num="(7)"> <text>Fail to display prominently on their person, in accordance with Regulation .04E of this chapter, the permit number of the mortuary transport service for which the registered transporter is employed;</text> </paragraph> <paragraph num="(8)"> <text>Dress or behave in an unprofessional manner while performing their official duties.</text> </paragraph> <paragraph num="(9)"> <text>Display in any removal vehicle any marking, sticker, or other indication of passage of a Board inspection other than the sticker issued by the Board;</text> </paragraph> <paragraph num="(10)"> <text>Advertise or solicit business directly to the family of a dying person or recently deceased person;</text> </paragraph> <paragraph num="(11)"> <text>Offer goods or services other than the service a permit authorizes the permit holder to provide;</text> </paragraph> <paragraph num="(12)"> <text>Sign a death certificate;</text> </paragraph> <paragraph num="(13)"> <text>Upon arrival at a location for the purpose of removing and transporting human remains, fail to:</text> <paragraph num="(a)"> <text>Verbally identify themselves as a registered transporter; and</text> </paragraph> <paragraph num="(b)"> <text>Identify the entity for whom they are removing and transporting human remains;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Perform their official duties in an unsanitary manner or in a manner that does not observe the Centers for Disease Control’s Guidelines on Universal Precautions; or</text> </paragraph> <paragraph num="(15)"> <text>Eat, drink, or smoke in the removal vehicle while in the performance of their official duties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Vehicle Standards."> <paragraph num="A."> <text>A removal vehicle shall:</text> <paragraph num="(1)"> <text>Be of appropriate size for the transport of human remains;</text> </paragraph> <paragraph num="(2)"> <text>Have windows tinted to the extent that human remains are obscured from public view;</text> </paragraph> <paragraph num="(3)"> <text>Have a cargo bay which:</text> <paragraph num="(a)"> <text>Is fully enclosed; and</text> </paragraph> <paragraph num="(b)"> <text>Is designed to prevent co-mingling or shifting of human remains while in transit; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have a floor which is a nonporous, impervious surface.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A removal vehicle shall include at least the following equipment:</text> <paragraph num="(1)"> <text>A removal stretcher and litter, each with a leakproof pouch; and</text> </paragraph> <paragraph num="(2)"> <text>A universal precaution kit which shall include the following:</text> <paragraph num="(a)"> <text>A red bio-waste bag;</text> </paragraph> <paragraph num="(b)"> <text>A heavy disaster pouch;</text> </paragraph> <paragraph num="(c)"> <text>Goggles;</text> </paragraph> <paragraph num="(d)"> <text>Booties;</text> </paragraph> <paragraph num="(e)"> <text>A mask;</text> </paragraph> <paragraph num="(f)"> <text>Disposable gloves;</text> </paragraph> <paragraph num="(g)"> <text>A clean or disposable apron;</text> </paragraph> <paragraph num="(h)"> <text>Antiseptic hand cleaner;</text> </paragraph> <paragraph num="(i)"> <text>Disinfectant spray;</text> </paragraph> <paragraph num="(j)"> <text>Clean towels; and</text> </paragraph> <paragraph num="(k)"> <text>A first-aid kit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Before the sale of a removal vehicle, the permit holder shall have the vehicle disinfected.</text> </paragraph> <paragraph num="D."> <text>Removal vehicles shall be inspected by a Board designated inspector at least every 2 years starting from the date of first inspection.</text> </paragraph> <paragraph num="E."> <text>A removal vehicle which has passed a Board inspection shall prominently display a Board-issued sticker on the vehicle attesting to passage of the inspection.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Fees."> <text>The following fees related to mortuary transport services are established by the Board:</text> <paragraph num="A."> <text>Mortuary Transport Service Permit:</text> <paragraph num="(1)"> <text>Initial fee:</text> <paragraph num="(a)"> <text>Category 1 (for 1 — 3 transporters, including the permit holder) — $350;</text> </paragraph> <paragraph num="(b)"> <text>Category 2 (for 4 — 7 transporters, including the permit holder) — $500;</text> </paragraph> <paragraph num="(c)"> <text>Category 3 (for 8 — 15 transporters, including the permit holder) — $750; and</text> </paragraph> <paragraph num="(d)"> <text>Category 4 (for more than 15 transporters, including the permit holder) — $1,000; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Renewal fee:</text> <paragraph num="(a)"> <text>The permit renewal fee shall be the same as the initial fee provided there has been no change in category;</text> </paragraph> <paragraph num="(b)"> <text>If the number of transporters employed by a mortuary transport service has increased, resulting in a change in category, the initial fee for the higher category shall be paid as the renewal fee; and</text> </paragraph> <paragraph num="(c)"> <text>If the number of transporters employed by a mortuary transport service has decreased, resulting in a change in category, the initial fee for the lower category shall be paid as the renewal fee;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Transporter registration processing fee (to add a transporter without change of category within the renewal cycle) — $40;</text> </paragraph> <paragraph num="C."> <text>Late fee (permit) — $400;</text> </paragraph> <paragraph num="D."> <text>Reinstatement fee — $350 + initial fee;</text> </paragraph> <paragraph num="E."> <text>Duplicate or replacement permit — $40;</text> </paragraph> <paragraph num="F."> <text>Duplicate registration — $50;</text> </paragraph> <paragraph num="G."> <text>Permit or registration verification fee — $40; and</text> </paragraph> <paragraph num="H."> <text>Replacement inspection sticker — $40.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Renewal Requirements."> <paragraph num="A."> <text>A mortuary transport service’s permit expires 30 days after the effective date of this chapter.</text> </paragraph> <paragraph num="B."> <text>After being issued an initial permit, a mortuary transport service’s permit:</text> <paragraph num="(1)"> <text>Expires on the date set by the Board, unless it is renewed for an additional term; and</text> </paragraph> <paragraph num="(2)"> <text>May not be renewed for a term longer than 2 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least 2 months before the permit expires, the Board shall issue a renewal notice to the permit holder that states:</text> <paragraph num="(1)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </paragraph> <paragraph num="(2)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The permit holder may renew the mortuary transport service permit for an additional term of 2 years if the permit holder:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be issued a permit;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a renewal fee set forth in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A completed renewal application on the form that the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>An updated criminal history records check; and</text> </paragraph> <paragraph num="(c)"> <text>An updated driving record, including probation before judgment findings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall impose the late fee established in Regulation .08 of this chapter on any permit holder who fails to renew their permit 1 month before it expires.</text> </paragraph> <paragraph num="F."> <text>A transporter’s registration is effective provided:</text> <paragraph num="(1)"> <text>It has not been suspended or revoked by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>The registered transporter is employed by a mortuary transport service which holds a permit issued by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reinstatement Requirements."> <paragraph num="A."> <text>To reinstate an expired permit, an individual shall:</text> <paragraph num="(1)"> <text>Resubmit the application required by the Board for initial applicants;</text> </paragraph> <paragraph num="(2)"> <text>Satisfy the education requirements stated in Regulation .04B of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Pay to the Board the reinstatement fee established by the Board in Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual whose registration has lapsed shall reapply to the Board under the procedure set forth in Regulation .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Multi-State Establishments."> <text>All vehicles registered by an establishment which is part of the same business structure as a licensed Maryland funeral establishment shall be inspected by the Board at a convenient location within the State if the related establishment intends to transport Maryland decedents in their vehicles.</text> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§7-101 and 7-601 — 7-607, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 17, 2014 (41:3 Md. R. 202)</annotation> </annotations> </chapter> <chapter num="22" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Temperature of Refrigeration Units."> <text>A refrigeration unit used in the storage of human remains shall be kept at a temperature lower than 40 degrees Fahrenheit.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §5-513; Health Occupations Article, §7-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 5, 2013 (40:15 Md. R. 1229)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 11, 2026 (53:9 Md. R. 413)</annotation> </annotations> </chapter> </subtitle> <subtitle num="30" heading="Maryland Commission on Kidney Disease"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>In recognition of its continuing responsibility to its citizens to aid in reduction of the personal financial hardships associated with end-stage kidney disease, the State continues its commitment of resources to the Kidney Disease Program of Maryland. This subtitle is designed so that Maryland may provide help and support for its citizens whose needs are partially or wholly unmet by present federal or private support, or both, for end stage kidney disease.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abusive and dangerous patient” means a patient who is physically or verbally threatening to the patient's person, facility staff, or other patients.</text> </paragraph> <paragraph num="(2)"> <text>“Acute dialysis” means dialysis employed in the treatment of temporary kidney failure, with the expectation that dialysis may be necessary for 4 weeks or less because recovery of kidney function is anticipated.</text> </paragraph> <paragraph num="(3)"> <text>“Administrator” means an individual appointed by the governing body who is responsible for the facility's daily operations and the duties set forth in COMAR 10.30.02.03F.</text> </paragraph> <paragraph num="(4)"> <text>“Certified nursing assistant—dialysis technician” means an individual licensed by the Maryland Board of Nursing to perform nursing tasks delegated by a licensed nurse in the dialysis facility.</text> </paragraph> <paragraph num="(5)"> <text>“Certified patient” means a patient who is certified by the Commission on Kidney Disease and is eligible for benefits from the Kidney Disease Program.</text> </paragraph> <paragraph num="(6)"> <text>“Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §494.180, which is incorporated by reference;</text> </paragraph> <paragraph num="(7)"> <text>“Chronic dialysis” means dialysis employed to compensate for the severe and irreversible loss of kidney function and is a permanent treatment modality unless replaced by kidney transplantation.</text> </paragraph> <paragraph num="(8)"> <text>“Chronic peritoneal dialysis” means dialysis performed repetitively by exchanging large volumes of solution within the peritoneal cavity.</text> </paragraph> <paragraph num="(9)"> <text>“Commission” means the Commission on Kidney Disease.</text> </paragraph> <paragraph num="(10)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(11)"> <text>Dialysis.</text> <paragraph num="(a)"> <text>“Dialysis” means the process of filtering waste products and excess fluid from the blood of a patient with severely compromised kidney function.</text> </paragraph> <paragraph num="(b)"> <text>“Dialysis” includes the terms hemodialysis and peritoneal dialysis.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Governing body” means an identifiable individual or individuals who are designated in writing with full legal authority and responsibility for the governance and operation of the facility.</text> </paragraph> <paragraph num="(13)"> <text>“Home dialysis” means chronic hemodialysis or chronic peritoneal dialysis performed regularly in the home by the patient and an assistant, if necessary.</text> </paragraph> <paragraph num="(14)"> <text>“Home training dialysis” means:</text> <paragraph num="(a)"> <text>Chronic peritoneal dialysis, including continuous ambulatory peritoneal dialysis and continuous cycling peritoneal dialysis; or</text> </paragraph> <paragraph num="(b)"> <text>Instructional chronic hemodialysis.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“In-center hemodialysis” means a hemodialysis treatment that:</text> <paragraph num="(a)"> <text>Lasts 3 to 5 hours;</text> </paragraph> <paragraph num="(b)"> <text>Is performed on a routine basis, usually three times a week, to treat a chronic condition; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided in a kidney dialysis facility.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“In-center nocturnal hemodialysis” means a hemodialysis treatment that:</text> <paragraph num="(a)"> <text>Lasts 6 to 9 hours;</text> </paragraph> <paragraph num="(b)"> <text>Is performed on a routine basis, usually three times a week, to treat a chronic condition; and</text> </paragraph> <paragraph num="(c)"> <text>Is provided in a kidney dialysis facility.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Monitoring individual” means an individual who is a direct patient care provider.</text> </paragraph> <paragraph num="(18)"> <text>“Nurse manager” means an individual who is responsible for nursing services and provides oversight and direction to all direct care staff that provide dialysis and nursing care in a kidney dialysis facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>42 CFR §§494.1 — 494.110, as amended; and</text> </paragraph> <paragraph num="(2)"> <text>42 CFR §§494.130 — 494.180, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Categories of Dialysis."> <paragraph num="A."> <text>The categories of dialysis listed in §§BF of this regulation are recognized on the basis of differing facility requirements.</text> </paragraph> <paragraph num="B."> <text>Acute Dialysis. Acute dialysis is not reimbursable under the Kidney Disease Program and nothing in this subtitle is meant to refer to acute dialysis.</text> </paragraph> <paragraph num="C."> <text>Chronic Dialysis.</text> <paragraph num="(1)"> <text>Chronic dialysis may be provided in the dialysis facilities defined and described in this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>Chronic dialysis may be preceded by adequate studies to confirm that the kidney failure is irreversible.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Home Dialysis. A period of training in an approved home dialysis training facility is required before a patient can safely undergo dialysis treatments in the home.</text> </paragraph> <paragraph num="E."> <text>Home Training Dialysis.</text> <paragraph num="(1)"> <text>Home training dialysis is usually conducted in a center with simultaneous dialysis and instruction provided to the patient that includes the technique of performing the type of dialysis selected.</text> </paragraph> <paragraph num="(2)"> <text>The period required for this training differs depending on the individual circumstances, and requires the expertise and equipment necessary for providing adequate home training.</text> </paragraph> <paragraph num="(3)"> <text>A responsible third party may be included in the training.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Chronic Peritoneal Dialysis.</text> <paragraph num="(1)"> <text>This process can substitute for kidney function that has been permanently lost and represents a permanent treatment unless replaced by either hemodialysis or kidney transplantation.</text> </paragraph> <paragraph num="(2)"> <text>Long-term care of end-stage kidney disease by chronic peritoneal dialysis may be carried out either in a dialysis facility or in the home.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Nocturnal Hemodialysis. Nocturnal hemodialysis may be provided in the dialysis facilities defined and described in this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Classifications of Facilities."> <paragraph num="A."> <text>Kidney Transplant Center.</text> <paragraph num="(1)"> <text>A kidney transplant center shall be a physically discrete unit or division within a hospital approved by the Joint Commission on Accreditation of Healthcare Organizations having the staff and facilities capable of evaluating potential candidates for kidney transplantation.</text> </paragraph> <paragraph num="(2)"> <text>Transplantation Service. The transplantation division may be administratively and physically separate from the dialysis division, but shall work in close cooperation with an associated dialysis program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Freestanding Dialysis Facility. The freestanding dialysis facility's functions include:</text> <paragraph num="(1)"> <text>A dialysis facility capable of providing chronic staff-assisted dialysis which may be performed in a freestanding dialysis facility or in an end-stage kidney disease certified hospital-based unit;</text> </paragraph> <paragraph num="(2)"> <text>Referrals provided for operative, X-ray, and laboratory services under arrangement;</text> </paragraph> <paragraph num="(3)"> <text>Affiliation with a certified dialysis facility for backup purposes; and</text> </paragraph> <paragraph num="(4)"> <text>Affiliation with a certified transplant center.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Home Dialysis Programs. A home dialysis program's functions include a dialysis facility specifically designed and staffed to train patients and patients' helpers to perform dialysis at home.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Standards."> <paragraph num="A."> <text>General Considerations.</text> <paragraph num="(1)"> <text>Patients who are accepted for dialysis and kidney transplantation:</text> <paragraph num="(a)"> <text>Shall be accepted on medical grounds alone;</text> </paragraph> <paragraph num="(b)"> <text>May not be accepted based on age, race, sex, social background, national origin, religion, or financial resources; and</text> </paragraph> <paragraph num="(c)"> <text>Are the responsibility of the dialysis or transplant centers, or both, but shall conform to the medical guidelines established in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Kidney Disease Program is financially responsible only for residents of the State who are certified as eligible for participation in the Kidney Disease Program.</text> </paragraph> <paragraph num="(3)"> <text>Maryland residents treated in dialysis facilities or transplant centers outside the State are not eligible for reimbursement unless the treatment has been preauthorized by the Commission.</text> </paragraph> <paragraph num="(4)"> <text>The Commission may authorize a treatment for documented reasons of continuity of care, or geographical proximity of the patient's residence to the dialysis facility or transplant center, or both.</text> </paragraph> <paragraph num="(5)"> <text>Except as provided in §C of this regulation, if a patient is accepted by a facility for dialysis, transplantation, or both, the patient is the responsibility of that facility and the facility's staff until that responsibility is terminated by mutual agreement between the facility and patient.</text> </paragraph> <paragraph num="(6)"> <text>The Commission shall review each facility's policy regarding discharge of patients from the facility's program.</text> </paragraph> <paragraph num="(7)"> <text>Any separation that is not mutually accepted shall be documented in writing by the facility and reviewed by the Commission to determine whether there has been a violation of laws or regulations of the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Guidelines. A patient may be accepted for treatment if the patient meets any of the following criteria:</text> <paragraph num="(1)"> <text>Has end-stage kidney disease requiring kidney replacement therapy to sustain life;</text> </paragraph> <paragraph num="(2)"> <text>A patient who grants informed consent and who has had a thorough medical, psychosocial evaluation indicating a reasonable expectation of benefiting from either chronic dialysis or transplantation;</text> </paragraph> <paragraph num="(3)"> <text>Has chronic end-stage kidney disease and is a qualified resident of this State, except when documented medical reasons contraindicate dialysis; or</text> </paragraph> <paragraph num="(4)"> <text>Has rejected a transplanted kidney making the patient immediately eligible for consideration for readmission into a chronic dialysis program if the patient is a medically suitable candidate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Abusive and Dangerous Patients.</text> <paragraph num="(1)"> <text>A facility shall:</text> <paragraph num="(a)"> <text>Develop policies for the management of abusive and dangerous patients;</text> </paragraph> <paragraph num="(b)"> <text>Maintain these policies in the policy and procedures manual in the dialysis facility; and</text> </paragraph> <paragraph num="(c)"> <text>Inform the patient in writing of the facility's policy for the management of abusive and dangerous patients.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A separation or discharge may be implemented by the facility only after the patient has been given written notice by the facility and has had a reasonable opportunity to terminate the abusive and dangerous behavior, however:</text> <paragraph num="(a)"> <text>A patient who commits violence in a facility may be discharged; and</text> </paragraph> <paragraph num="(b)"> <text>The Commission shall require documentation of the violence to support a discharge.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission shall review each facility's policy for the management of abusive and dangerous patients and the facility's method of implementation of this policy during the Commission's survey.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Complaints.</text> <paragraph num="(1)"> <text>The Commission shall investigate complaints received from patients, providers, anonymous persons, and other interested parties including family members.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall consider all complaints submitted to the Commission office for further investigation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reimbursement Principles."> <text>A certified facility and recipient shall comply with COMAR 10.20.01 and with the requirements of this chapter to be eligible for reimbursement.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedures for Certification of Facilities."> <paragraph num="A."> <text>Providers or consumers of medical care contemplating development of a transplant center or a dialysis facility shall notify the Commission within 30 days of applying for licensure or certification with the Office of Health Care Quality of the Department.</text> </paragraph> <paragraph num="B."> <text>The Department or the Commission, or both, shall:</text> <paragraph num="(1)"> <text>Review the facility application;</text> </paragraph> <paragraph num="(2)"> <text>Survey for compliance with this subtitle; and</text> </paragraph> <paragraph num="(3)"> <text>Certify the facility’s existing Office of Health Care Quality license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission, through the Department, shall certify the dialysis facilities and transplant centers once the standards have been met as set forth in this subtitle.</text> </paragraph> <paragraph num="D."> <text>Certified patients are eligible for reimbursement of medical care only after a dialysis facility or transplant center has received Kidney Disease Program certification.</text> </paragraph> <paragraph num="E."> <text>Programs denied certification on the basis of a failure to meet the Commission's standards may file an appeal with the Commission for a specific interpretation of the standards applicable in that individual case.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Affiliation Guidelines."> <paragraph num="A."> <text>To assure quality and continuity of patient care, formal affiliation agreements shall be negotiated as required in the standards and guidelines of the Commission. The affiliation agreement shall be constructed so no entity benefits financially.</text> </paragraph> <paragraph num="B."> <text>Affiliation agreements shall include, but not necessarily be limited to, the:</text> <paragraph num="(1)"> <text>Means by which patients may be transferred between the affiliated institutions for the purpose of providing dialysis, transplantation services, or other medical care;</text> </paragraph> <paragraph num="(2)"> <text>Conditions under which dialysis facilities, hospitals, and transplant centers agree to provide medical backup facility to assure optimal patient care;</text> </paragraph> <paragraph num="(3)"> <text>Mechanisms for assuring quality of care including provisions for consultative help and review of patient progress;</text> </paragraph> <paragraph num="(4)"> <text>Provisions of or referral to a certified home dialysis training program with specific mechanisms for ensuring adequate supervision and assistance for patients on home dialysis; and</text> </paragraph> <paragraph num="(5)"> <text>Specific provisions by hospitals to end-stage kidney disease patients for dialysis services as well as adequate:</text> <paragraph num="(a)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(b)"> <text>Social services; and</text> </paragraph> <paragraph num="(c)"> <text>Dietetic services;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The dialysis facility shall review and revise the affiliation agreements periodically and if a change in ownership or other details of operation changes during the period while the affiliation agreement is in force.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Residency Requirements."> <text>To be eligible for the Kidney Disease Program, an individual shall be one of the following:</text> <paragraph num="A."> <text>A citizen of the United States residing in Maryland; or</text> </paragraph> <paragraph num="B."> <text>An alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law, including an alien who is lawfully present in the United States pursuant to 8 U.S.C. §1101 et seq. and who is residing in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Certification and Revocation."> <paragraph num="A."> <text>Certification.</text> <paragraph num="(1)"> <text>The Commission, through the Department, shall certify a facility or center to perform dialysis upon determination that the facility or center meets the standards adopted by the Commission, including:</text> <paragraph num="(a)"> <text>42 CFR §§494.1 — 494.110, as amended; and</text> </paragraph> <paragraph num="(b)"> <text>42 CFR §§494.130 — 494.180, as amended.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The certification of the facility or center shall continue in effect unless suspended or revoked by the Secretary as recommended by the Commission.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Revocation of Certification or Suspension of Payments.</text> <paragraph num="(1)"> <text>The Secretary shall delegate to the Commission the performance of periodic surveys of dialysis facilities or transplant centers.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall immediately report to the Secretary if patient safety and welfare are compromised at the facility. However, this reporting does not preclude the Commission from taking immediate independent corrective action.</text> </paragraph> <paragraph num="(3)"> <text>The Commission may, by vote of the majority of the members in attendance, recommend to the Secretary to revoke or suspend payments to a dialysis facility or transplant center not in compliance with this subtitle.</text> </paragraph> <paragraph num="(4)"> <text>Reimbursements may not be made during the term of the suspension or revocation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Secretary may revoke the certification of a dialysis facility or transplant center to participate in the Kidney Disease Program at any time for failure to comply with this subtitle.</text> </paragraph> <paragraph num="D."> <text>The Commission may review any revocation or proposed revocation of certification and make an independent recommendation to the Secretary.</text> </paragraph> <paragraph num="E."> <text>In accordance with the Maryland Administrative Procedure Act, a person aggrieved by a decision of the Secretary is entitled to a hearing in accordance with COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Miscellaneous Items."> <paragraph num="A."> <text>A serious occurrence which threatens the safety and health of the patients shall be reported immediately by a facility to the Commission, local health department, and the Office of Health Care Quality of the Department.</text> </paragraph> <paragraph num="B."> <text>In the event of a natural disaster or other imminent threat to the safety or health of a group of dialysis patients, the Secretary may immediately authorize, with timely notification of all involved professional personnel and patients, the:</text> <paragraph num="(1)"> <text>Relocation of an existing dialysis facility or center; and</text> </paragraph> <paragraph num="(2)"> <text>Transfer of dialysis patients in accordance with medical needs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency Management.</text> <paragraph num="(1)"> <text>A kidney dialysis facility shall have an emergency plan.</text> </paragraph> <paragraph num="(2)"> <text>An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address:</text> <paragraph num="(a)"> <text>The safe management of individuals who are receiving services at the kidney dialysis facility when an emergency occurs;</text> </paragraph> <paragraph num="(b)"> <text>Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis facility;</text> </paragraph> <paragraph num="(c)"> <text>Staff coverage, organization, and assignment of responsibilities; and</text> </paragraph> <paragraph num="(d)"> <text>The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>This regulation does not prohibit a kidney dialysis facility from applying for and receiving reimbursement:</text> <paragraph num="(a)"> <text>Under any applicable insurance policy; or</text> </paragraph> <paragraph num="(b)"> <text>From any State or federal funds that may be available due to a declared State or federal emergency.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A kidney dialysis facility is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation.</text> </paragraph> <paragraph num="(5)"> <text>For purposes of coordinating local emergency planning efforts, a kidney dialysis facility shall provide access to the emergency plan developed under this regulation to local organizations for emergency management.</text> </paragraph> <paragraph num="(6)"> <text>A dialysis provider shall provide to the Commission a 24/7 live operational contact phone number.</text> </paragraph> <paragraph num="(7)"> <text>Information Regarding the Status of Generators. A kidney dialysis facility shall have:</text> <paragraph num="(a)"> <text>An on-site generator;</text> </paragraph> <paragraph num="(b)"> <text>The capacity to hook up a generator; or</text> </paragraph> <paragraph num="(c)"> <text>A contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>If the center has no plan to use the services of a generator, the center shall provide to the Commission a copy of the center's emergency plan that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1972</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 repealed and new regulations .01 — .09 adopted effective July 19, 1982 (9:14 Md. R. 1431)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04, .05, and .07L amended effective August 1, 1983 (10:15 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective February 27, 1984 (11:4 Md. R. 314); August 20, 1987 (14:16 Md. R. 1775); November 16, 1987 (14:23 Md. R. 2414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B and Q amended as an emergency provision effective January 1, 1987 (14:6 Md. R. 711, 14:9 Md. R. 1077); emergency status expired August 20, 1987 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended effective July 2, 1984 (11:13 Md. R. 1777); August 20, 1987 (14:16 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07Q amended as an emergency provision effective July 2, 1984 (11:15 Md. R. 1327); adopted permanently effective December 19, 1984 (11:23 Md. R. 1992)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07R adopted effective August 1, 1983 (10:15 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07S adopted as an emergency provision effective September 14, 1983 (10:20 Md. R. 1781); emergency status expired January 31, 1984 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective December 20, 1982 (9:25 Md. R. 2484)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11 and .13 adopted effective August 1, 1983 (10:15 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective November 3, 1986 (13:22 Md. R. 2399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective June 4, 1984 (11:11 Md. R. 962)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 31, 1988 (15:22 Md. R. 2556)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 15, 1991 (18:7 Md. R. 773); May 20, 1996 (23:10 Md. R. 732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective May 20, 1996 (23:10 Md. R. 732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A and M amended effective April 15, 1991 (18:7 Md. R. 773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted as an emergency provision effective July 1, 1992 (19:13 Md. R. 1200); emergency status expired November 8, 1992 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective May 9, 1994 (21:9 Md. R. 751)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 repealed and new Regulation .15 adopted effective October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15F repealed effective August 23, 1999 (26:17 Md. R. 1323)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 adopted effective December 19, 1994 (21:25 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 repealed and new Regulations .01 — .11 adopted effective December 22, 2003 (30:25 Md. R. 1846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G adopted effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C adopted effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 18, 2025 (52:16 Md. R. 846)</annotation> </annotations> </chapter> <chapter num="02" heading="Physical and Medical Standards"> <regulation prefix="Regulation" num=".01" heading="Repealed." /> <regulation prefix="Regulation" num=".02" heading="Transplant Centers."> <paragraph num="A."> <text>Location and Program Affiliation.</text> <paragraph num="(1)"> <text>Centers seeking certification as transplant centers, under Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall be located in hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations and participate in a patient registry program with a certified organ procurement organization.</text> </paragraph> <paragraph num="(2)"> <text>An agreement shall exist with an established functioning tissue typing laboratory providing 24-hour-a-day service.</text> </paragraph> <paragraph num="(3)"> <text>The hospital shall provide an active nephrology service to provide for continuity of care.</text> </paragraph> <paragraph num="(4)"> <text>The transplantation program shall conform to generally accepted medical standards for tissue typing and for transplantation.</text> </paragraph> <paragraph num="(5)"> <text>For the purpose of protecting patient safety and welfare, a transplant center may not discontinue or phase out patient services until:</text> <paragraph num="(a)"> <text>The transplant center has notified the Commission of the transplant center's intention;</text> </paragraph> <paragraph num="(b)"> <text>Patients being treated by that transplant center have been transferred to another transplant center;</text> </paragraph> <paragraph num="(c)"> <text>Patients' continuing care has been assured to the satisfaction of the patient and the Commission;</text> </paragraph> <paragraph num="(d)"> <text>The transplant center submits to the Commission evidence that the transfer of patients to another transplant center has been satisfactorily accomplished; and</text> </paragraph> <paragraph num="(e)"> <text>Patients being treated in a transplant center that is withdrawing from the Kidney Disease Program are provided continued access to the same reimbursement principles of the Kidney Disease Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Physical Standards. The transplant center shall be located in a hospital that is participating as a provider of services in the Medicare program and is approved by Centers for Medicare and Medicaid Services as a kidney transplantation center.</text> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Director of Transplantation Center. The kidney transplantation center shall be under the general supervision of:</text> <paragraph num="(a)"> <text>A UNOS qualified transplantation surgeon (42 CFR §405.2102) and a qualified transplant nephrology physician director; or</text> </paragraph> <paragraph num="(b)"> <text>Another physician meeting UNOS criteria as a physician director for kidney transplantation (42 CFR §405.2102).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The director shall be responsible for planning, organizing, conducting and directing the transplant center and devoting sufficient time to carry out these responsibilities, which include but are not limited to:</text> <paragraph num="(a)"> <text>Coordinating with the hospital in which the transplant center is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors;</text> </paragraph> <paragraph num="(b)"> <text>Ensuring that tissue typing and organ procurement services are available through a UNOS associated OPO and an ASHI certified laboratory;</text> </paragraph> <paragraph num="(c)"> <text>Ensuring that transplantation surgery is performed by, or under the direct supervision of, a UNOS qualified transplant surgeon; and</text> </paragraph> <paragraph num="(d)"> <text>Ensuring that the transplant center shall have an adequate number of clinical transplant coordinators to ensure the continuity of care of patients and living donors during the:</text> <paragraph num="(i)"> <text>Pre-transplant, transplant, and discharge phases of transplant; and</text> </paragraph> <paragraph num="(ii)"> <text>Donor evaluation, donation, and discharge phases of donation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The clinical transplant coordinator shall:</text> <paragraph num="(a)"> <text>Be a registered nurse or clinician licensed by the state in which the clinical transplant coordinator practices; and</text> </paragraph> <paragraph num="(b)"> <text>Have experience and knowledge of transplantation and living donation issues.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The clinical transplant coordinator's responsibilities include, but are not limited to:</text> <paragraph num="(a)"> <text>Ensuring the coordination of the clinical aspects of transplant patient and living donor care; and</text> </paragraph> <paragraph num="(b)"> <text>Acting as a liaison between kidney transplant centers and dialysis facilities.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The transplant center that performs living donor transplantation shall identify either an independent living donor advocate or an independent living donor advocate team to ensure the protection of the rights of living donors and prospective living donors.</text> </paragraph> <paragraph num="(6)"> <text>The living donor advocate or living donor advocate team may not be involved in transplantation activities on a routine basis.</text> </paragraph> <paragraph num="(7)"> <text>The kidney transplant center shall:</text> <paragraph num="(a)"> <text>Directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients; and</text> </paragraph> <paragraph num="(b)"> <text>Have written policies and procedures for ongoing communications with the dialysis patients' local dialysis facilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Additional Transplant Program Requirements.</text> <paragraph num="(1)"> <text>Sufficient skilled personnel shall be available to provide 24-hour-a-day coverage for the transplantation service.</text> </paragraph> <paragraph num="(2)"> <text>A transplantation team shall exist in a certified transplant center consisting of:</text> <paragraph num="(a)"> <text>The transplant center director;</text> </paragraph> <paragraph num="(b)"> <text>The director's assistant; and</text> </paragraph> <paragraph num="(c)"> <text>A UNOS certified transplant surgeon, if not the transplant center director, and a UNOS certified physician director (a transplant nephrologist or physician meeting UNOS criteria to be a physician director for a kidney transplant program).</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Physical and Medical Standards. The transplant center shall:</text> <paragraph num="(1)"> <text>Provide support services in clinical immunology, infectious diseases, and immunopathology; and</text> </paragraph> <paragraph num="(2)"> <text>Be an administratively separate and distinct division or unit.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Transplant Activity.</text> <paragraph num="(1)"> <text>For optimum performance and success of the transplant procedure, transplant centers shall perform a minimum of 10 transplants per year.</text> </paragraph> <paragraph num="(2)"> <text>The Commission recognizes that the number of transplants performed depends on many variables and the standard specified in §F(1) of this regulation serves only as a guideline.</text> </paragraph> <paragraph num="(3)"> <text>The guideline specified in §F(1) of this regulation is established to indicate that transplant centers shall remain active in order to improve the success rate and to lower costs.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The transplant center shall make arrangements for medical records, patient care policies, dietetic services, sanitation standards, and fire and life safety standards as referenced in this subtitle.</text> </paragraph> <paragraph num="H."> <text>Patient Treatment Eligibility.</text> <paragraph num="(1)"> <text>In general, the patient eligibility standards as established for the dialysis program shall apply to the transplantation program, recognizing that constant improvements in the immunology and treatment of the rejection process are increasing the number of disease processes in which transplantation is applicable.</text> </paragraph> <paragraph num="(2)"> <text>Written recommendations about the mode of therapy shall be kept on file for the review of the Commission.</text> </paragraph> <paragraph num="(3)"> <text>Since transplantation is at present the best means of treating most patients with irreversible kidney failure, transplantation shall be considered for all patients accepted into this program when reasonable benefit and success are anticipated. However, candidacy for transplantation may not be a basic criteria for eligibility into the overall Kidney Disease Program.</text> </paragraph> <paragraph num="(4)"> <text>A patient rejecting a transplanted kidney shall automatically receive assistance to gain entry into a dialysis program.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Administration.</text> <paragraph num="(1)"> <text>The transplant center shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the transplant patients.</text> </paragraph> <paragraph num="(2)"> <text>Before placement on the center's waiting list, a prospective transplant candidate shall:</text> <paragraph num="(a)"> <text>Receive a psychosocial evaluation; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When a patient is placed on a center's waiting list or is selected to receive a transplant, the center shall document in the patient's medical record the patient's eligibility criteria used.</text> </paragraph> <paragraph num="(4)"> <text>The transplant center shall provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or dialysis facility.</text> </paragraph> <paragraph num="(5)"> <text>The transplant center shall have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also shall have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation.</text> </paragraph> <paragraph num="(6)"> <text>The transplant center's patient and donor management policies shall ensure that:</text> <paragraph num="(a)"> <text>Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and</text> </paragraph> <paragraph num="(b)"> <text>If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician through the donor evaluation, donation, and discharge phases of donation.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A transplant center shall keep their waiting lists up to date on an ongoing basis including:</text> <paragraph num="(a)"> <text>Updating of waiting list patients' clinical information;</text> </paragraph> <paragraph num="(b)"> <text>Removing patients from the center's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a center's waiting list;</text> </paragraph> <paragraph num="(c)"> <text>Notifying the Organ Procurement and Transplant Network not later than 24 hours after a patient's removal from the center's waiting list; and</text> </paragraph> <paragraph num="(d)"> <text>Notifying the patient and dialysis facility if applicable if the patient is removed from the center's waiting list.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The transplant center shall develop guidelines to ensure adequate patient and freestanding dialysis facility notification of change in patient transplant status.</text> </paragraph> <paragraph num="(9)"> <text>The transplant center shall maintain up-to-date patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation.</text> </paragraph> <paragraph num="(10)"> <text>The transplant center shall make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families.</text> </paragraph> <paragraph num="(11)"> <text>The transplant center shall develop, implement, and maintain a written comprehensive data driven Quality Assessment and Performance Improvement (QAPI) program designed to monitor and evaluate performance of all transplantation services. The QAPI program shall include, but not be limited to:</text> <paragraph num="(a)"> <text>Patient and donor eligibility criteria;</text> </paragraph> <paragraph num="(b)"> <text>Accuracy of the waiting list;</text> </paragraph> <paragraph num="(c)"> <text>Assurance of donor and recipient matching;</text> </paragraph> <paragraph num="(d)"> <text>Patient and donor management;</text> </paragraph> <paragraph num="(e)"> <text>Consent practices;</text> </paragraph> <paragraph num="(f)"> <text>Patient education;</text> </paragraph> <paragraph num="(g)"> <text>Patient satisfaction; and</text> </paragraph> <paragraph num="(h)"> <text>Patient rights.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>The transplant center shall take actions that result in performance improvements and track performance to ensure that improvements are sustained.</text> </paragraph> <paragraph num="(13)"> <text>The transplant center shall establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.</text> </paragraph> <paragraph num="(14)"> <text>The hospital shall provide designated administrative personnel to keep the necessary records as well as other information needed for accurate determination of cost.</text> </paragraph> <paragraph num="(15)"> <text>The hospital or transplant center administration shall assure that patients are informed of the center's internal and external grievance mechanisms.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Compliance. Transplant centers shall comply with the provisions set forth in this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Freestanding Dialysis Facilities — General."> <paragraph num="A."> <text>Location and Program Affiliation.</text> <paragraph num="(1)"> <text>Freestanding dialysis facilities seeking a certification as a freestanding dialysis facility, under the terms of Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall have, for the diagnosis and treatment of irreversible kidney failure and its complications, arrangements with:</text> <paragraph num="(a)"> <text>A laboratory that meets the needs of end-stage kidney disease patients;</text> </paragraph> <paragraph num="(b)"> <text>A hospital that can provide acute care services to meet the needs of end-stage kidney disease patients;</text> </paragraph> <paragraph num="(c)"> <text>A backup dialysis facility; and</text> </paragraph> <paragraph num="(d)"> <text>Transplant services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A freestanding dialysis facility desiring to phase out or discontinue dialysis services shall notify the Commission as soon as the decision to withdraw the facility from the Kidney Disease Program has been made by the administration of the facility.</text> </paragraph> <paragraph num="(3)"> <text>A freestanding dialysis facility withdrawal from the Kidney Disease Program may not be accomplished until:</text> <paragraph num="(a)"> <text>Patients being treated by that freestanding dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patient and the Commission;</text> </paragraph> <paragraph num="(b)"> <text>The freestanding dialysis facility has submitted to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and</text> </paragraph> <paragraph num="(c)"> <text>Patients previously certified and being treated in a freestanding dialysis facility that is being withdrawn from the Kidney Disease Program have continued access to the same reimbursement principle of the Kidney Disease Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Physical Standards. The freestanding dialysis facility shall:</text> <paragraph num="(1)"> <text>Have usable floor space of at least 80 square feet per patient station that may include bed or chair space, nursing space, and work area but excludes storage space;</text> </paragraph> <paragraph num="(2)"> <text>Have at least 20 square feet of the patient station floor space available on the side of the patient to be occupied by the dialysis assembly;</text> </paragraph> <paragraph num="(3)"> <text>Arrange the space to be sufficiently flexible to provide access to any of the four extremities;</text> </paragraph> <paragraph num="(4)"> <text>Contain a nursing station and be designed for patient privacy, surveillance, and isolation when indicated;</text> </paragraph> <paragraph num="(5)"> <text>Provide refrigerated and nonrefrigerated storage space;</text> </paragraph> <paragraph num="(6)"> <text>Provide sufficient area and space for:</text> <paragraph num="(a)"> <text>Maintenance of equipment;</text> </paragraph> <paragraph num="(b)"> <text>Storage of the equipment and supplies; and</text> </paragraph> <paragraph num="(c)"> <text>Preparing and testing dialyzers;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation's recommendations which are incorporated by reference in this subtitle to prevent bacterial or endotoxin contamination or toxic accumulation of trace elements in patients undergoing long-term dialysis;</text> </paragraph> <paragraph num="(8)"> <text>Comply with medical records, patient care policies, sanitation standards, and fire and life safety standards as set forth in this subtitle; and</text> </paragraph> <paragraph num="(9)"> <text>Comply with the quality assurance program as identified in Regulation .04B(3)(s) of this chapter and provide:</text> <paragraph num="(a)"> <text>Summarized format documentation, upon request, of the facility’s quality assurance program; and</text> </paragraph> <paragraph num="(b)"> <text>Written documentation of the facility’s meeting attendance, goals, outcomes, and action plans, including evaluation and revision of the plans, as appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Administration.</text> <paragraph num="(1)"> <text>The freestanding dialysis facility shall be under the supervision of the governing body. The governing body shall:</text> <paragraph num="(a)"> <text>Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Develop a written organizational plan.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The freestanding dialysis facility administration shall:</text> <paragraph num="(a)"> <text>Be under the supervision of the governing body; and</text> </paragraph> <paragraph num="(b)"> <text>Provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The freestanding dialysis facility shall provide designated administrative personnel to keep necessary records as well as other information for accurate determination of costs.</text> </paragraph> <paragraph num="(4)"> <text>The freestanding dialysis facility administration shall assure that patients are informed of the facility's internal and external grievance mechanisms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Compliance. Freestanding dialysis facilities shall comply with:</text> <paragraph num="(1)"> <text>The provisions set forth in this subtitle;</text> </paragraph> <paragraph num="(2)"> <text>Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>The requirements of this subtitle for certification purposes with the Commission.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Governing Body. The governing body shall:</text> <paragraph num="(1)"> <text>Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and</text> </paragraph> <paragraph num="(2)"> <text>Develop a written organizational plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Administrator.</text> <paragraph num="(1)"> <text>Qualifications.</text> <paragraph num="(a)"> <text>The kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum:</text> <paragraph num="(i)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(ii)"> <text>Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation;</text> </paragraph> <paragraph num="(iii)"> <text>Have at least 1 year of dialysis experience; and</text> </paragraph> <paragraph num="(iv)"> <text>Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through a criminal history records check completed within 1 month before employment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The administrator, if not the chief executive officer, shall have knowledge in:</text> <paragraph num="(i)"> <text>Infection control;</text> </paragraph> <paragraph num="(ii)"> <text>Principles of dialysis;</text> </paragraph> <paragraph num="(iii)"> <text>Water treatment;</text> </paragraph> <paragraph num="(iv)"> <text>Reuse;</text> </paragraph> <paragraph num="(v)"> <text>Data collection and quality assurance;</text> </paragraph> <paragraph num="(vi)"> <text>Emergency procedures;</text> </paragraph> <paragraph num="(vii)"> <text>Fiscal operations, including business management and personnel;</text> </paragraph> <paragraph num="(viii)"> <text>Regulations; and</text> </paragraph> <paragraph num="(ix)"> <text>Policies and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Duties.</text> <paragraph num="(a)"> <text>The administrator shall be on site or available on call.</text> </paragraph> <paragraph num="(b)"> <text>The administrator shall have overall responsibility for:</text> <paragraph num="(i)"> <text>Implementing the facility's policies and coordinating the provision of services that the facility provides;</text> </paragraph> <paragraph num="(ii)"> <text>Organizing and coordinating the administrative functions of the facility;</text> </paragraph> <paragraph num="(iii)"> <text>Establishing procedures for the accountability of those personnel involved in patient care;</text> </paragraph> <paragraph num="(iv)"> <text>Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="(v)"> <text>Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters;</text> </paragraph> <paragraph num="(vi)"> <text>Participating in the development of organizational and fiscal planning for the facility;</text> </paragraph> <paragraph num="(vii)"> <text>Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and</text> </paragraph> <paragraph num="(viii)"> <text>Informing patients of the availability of emergency services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Waiver of Requirements for Administrator.</text> <paragraph num="(a)"> <text>The Commission may grant a kidney dialysis facility a waiver, with or without conditions, for a facility that operates an administrator-in-training program.</text> </paragraph> <paragraph num="(b)"> <text>A facility with an administrator-in-training program shall submit to the Commission the:</text> <paragraph num="(i)"> <text>Administrator-in-training curriculum, including course outline and supporting materials;</text> </paragraph> <paragraph num="(ii)"> <text>Facility requirements for individuals who are eligible to participate in the administrator-in-training program; and</text> </paragraph> <paragraph num="(iii)"> <text>Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In evaluating a waiver request submitted under this regulation, the Commission shall review the statements in the application and may:</text> <paragraph num="(i)"> <text>Inspect the kidney dialysis center; or</text> </paragraph> <paragraph num="(ii)"> <text>Confer with the governing body.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Grant or Denial of Waiver. The Commission may grant a waiver request if it determines that:</text> <paragraph num="(i)"> <text>The administrator-in-training program sufficiently meets the requirements of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>A waiver will not adversely affect patients.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If the Commission determines that the conditions of §F(1) and (2) of this regulation are not met, the Commission shall deny the request for a waiver. The denial of a waiver may not be appealed.</text> </paragraph> <paragraph num="(f)"> <text>Written Decision.</text> <paragraph num="(i)"> <text>The Commission shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request.</text> </paragraph> <paragraph num="(ii)"> <text>If the Commission grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed.</text> </paragraph> <paragraph num="(h)"> <text>Any substantive changes to the administrator-in-training program shall be submitted to the Commission for prior approval.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Policies and Procedures. The administrator shall:</text> <paragraph num="(a)"> <text>In consultation with the governing body, develop and implement policies and procedures governing the operation of the facility, which include at a minimum those items in §F(1) and (2) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that all policies and procedures are:</text> <paragraph num="(i)"> <text>Reviewed by the governing body at least annually and are revised as necessary;</text> </paragraph> <paragraph num="(ii)"> <text>Available at all times for staff inspection and use; and</text> </paragraph> <paragraph num="(iii)"> <text>Appropriate personnel implement all policies and procedures adopted.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Freestanding Dialysis Facilities — Staffing."> <paragraph num="A."> <text>Nephrologist or Physician.</text> <paragraph num="(1)"> <text>The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis.</text> </paragraph> <paragraph num="(2)"> <text>Each freestanding dialysis facility shall have:</text> <paragraph num="(a)"> <text>At least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage; or</text> </paragraph> <paragraph num="(b)"> <text>A licensed professional trained in dialysis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director.</text> <paragraph num="(1)"> <text>Each freestanding dialysis facility shall appoint a medical director.</text> </paragraph> <paragraph num="(2)"> <text>The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics and:</text> <paragraph num="(a)"> <text>Has at least 12 months of experience or training in the care of patients at end-stage kidney disease facilities; or</text> </paragraph> <paragraph num="(b)"> <text>Has served at least 12 months as a director of a dialysis or transplantation program before 1976.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The medical director shall:</text> <paragraph num="(a)"> <text>Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;</text> </paragraph> <paragraph num="(b)"> <text>Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures;</text> </paragraph> <paragraph num="(c)"> <text>Coordinate the comprehensive kidney health care team to assure quality of care;</text> </paragraph> <paragraph num="(d)"> <text>Assure there are written policies which address patient care plans to select the appropriate end stage kidney disease modality;</text> </paragraph> <paragraph num="(e)"> <text>Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility;</text> </paragraph> <paragraph num="(f)"> <text>Assure that the end stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;</text> </paragraph> <paragraph num="(g)"> <text>Assure the appropriate execution of the dialysis orders and day to day patient care policy by the nursing and technical staff;</text> </paragraph> <paragraph num="(h)"> <text>Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;</text> </paragraph> <paragraph num="(i)"> <text>Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;</text> </paragraph> <paragraph num="(j)"> <text>Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;</text> </paragraph> <paragraph num="(k)"> <text>Supervise the development of a dialysis water standards policy including implementation, monitoring, and enforcement;</text> </paragraph> <paragraph num="(l)"> <text>Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;</text> </paragraph> <paragraph num="(m)"> <text>Supervise the development of freestanding dialysis policies on the administration of intradialytic medications;</text> </paragraph> <paragraph num="(n)"> <text>Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;</text> </paragraph> <paragraph num="(o)"> <text>Assure that there are written policies regarding patient care and facility personnel organization;</text> </paragraph> <paragraph num="(p)"> <text>Assure that there are written policies regarding patient education;</text> </paragraph> <paragraph num="(q)"> <text>Assure that there are written policies regarding medical staff bylaws and physician credentialing;</text> </paragraph> <paragraph num="(r)"> <text>Assure that there are written policies regarding freestanding dialysis policies for anemia management, adequacy of dialysis measures, infection control, dialysis water standards, immunization guidelines for Hepatitis B, influenza, pneumococcal vaccines, and any other applicable vaccines, and use of Vitamin D analogues and monitoring parameters associated with the development of kidney osteodystrophy;</text> </paragraph> <paragraph num="(s)"> <text>Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program;</text> </paragraph> <paragraph num="(t)"> <text>Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility;</text> </paragraph> <paragraph num="(u)"> <text>Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and</text> </paragraph> <paragraph num="(v)"> <text>Establish documented practice goals within the freestanding dialysis facility to assure optimal patient care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Nursing Services.</text> <paragraph num="(1)"> <text>Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that:</text> <paragraph num="(a)"> <text>Is a full time employee of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Is a registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>Has at least:</text> <paragraph num="(i)"> <text>12 months of experience in clinical nursing; and</text> </paragraph> <paragraph num="(ii)"> <text>An additional 6 months experience in providing nursing care to patients on maintenance dialysis; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Participates in the facility's Quality Assessment and Performance Improvement Program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charge Nurse. The charge nurse responsible for each shift:</text> <paragraph num="(a)"> <text>Shall be a registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Shall be on duty in the treatment area, at all times when patients are being treated, except for while on breaks, when the charge nurse shall be readily available;</text> </paragraph> <paragraph num="(c)"> <text>Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and</text> </paragraph> <paragraph num="(d)"> <text>May not be included in the staffing ratio except:</text> <paragraph num="(i)"> <text>When there are nine or fewer patients; or</text> </paragraph> <paragraph num="(ii)"> <text>In the event of an emergency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staffing Exception Reporting.</text> <paragraph num="(a)"> <text>The freestanding dialysis facility shall have a staffing exception reporting protocol in a format approved by the Commission for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include:</text> <paragraph num="(i)"> <text>The date and shift of the exception;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the emergency staffing situation;</text> </paragraph> <paragraph num="(iii)"> <text>Actions taken in response; and</text> </paragraph> <paragraph num="(iv)"> <text>Any measures taken to ensure the center's future compliance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The exception reporting protocol shall be included in the center's quality assurance process.</text> </paragraph> <paragraph num="(c)"> <text>The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Direct Patient Care Providers.</text> <paragraph num="(1)"> <text>Staffing Ratio.</text> <paragraph num="(a)"> <text>The monitoring individual-to-patient ratio at each facility shall be:</text> <paragraph num="(i)"> <text>A minimum of one staff member to three participants; and</text> </paragraph> <paragraph num="(ii)"> <text>Sufficient to meet the needs of patients.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The facility shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A monitoring individual shall:</text> <paragraph num="(a)"> <text>Be trained in dialysis procedures and may be a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(iii)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(iv)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(v)"> <text>Licensed practical nurse; or</text> </paragraph> <paragraph num="(vi)"> <text>Certified nursing assistant—dialysis technician; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide direct patient care during treatment, which shall include at a minimum:</text> <paragraph num="(i)"> <text>Initiation of treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Termination of treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Monitoring vital signs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.</text> </paragraph> <paragraph num="F."> <text>The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.</text> </paragraph> <paragraph num="G."> <text>Psychiatric services may be obtained by referral to a licensed psychiatrist.</text> </paragraph> <paragraph num="H."> <text>Social Worker.</text> <paragraph num="(1)"> <text>The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.</text> </paragraph> <paragraph num="(2)"> <text>Annual Psychosocial Update.</text> <paragraph num="(a)"> <text>A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.</text> </paragraph> <paragraph num="(b)"> <text>The annual psychosocial update shall include, at a minimum, the issues below:</text> <paragraph num="(i)"> <text>Review of treatment options;</text> </paragraph> <paragraph num="(ii)"> <text>Vocational rehabilitation;</text> </paragraph> <paragraph num="(iii)"> <text>Adjustment to illness issues;</text> </paragraph> <paragraph num="(iv)"> <text>Patient behaviors that may warrant discharge; and</text> </paragraph> <paragraph num="(v)"> <text>Any changes in the patient's relationships, living situation, and living wills.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The social worker shall document progress notes:</text> <paragraph num="(a)"> <text>At least quarterly for stable patients; and</text> </paragraph> <paragraph num="(b)"> <text>At least monthly or more frequently for unstable patients including, but not limited to, patients experiencing:</text> <paragraph num="(i)"> <text>Adult Protective Services or Child Protective Services involvement;</text> </paragraph> <paragraph num="(ii)"> <text>Housing crisis or change;</text> </paragraph> <paragraph num="(iii)"> <text>Change in support system if patient is a vulnerable adult or child;</text> </paragraph> <paragraph num="(iv)"> <text>Violent or abusive behaviors or events;</text> </paragraph> <paragraph num="(v)"> <text>Emotional or psychological crisis including suicidal tendencies or emotional distress;</text> </paragraph> <paragraph num="(vi)"> <text>Death or major illness in the family;</text> </paragraph> <paragraph num="(vii)"> <text>Financial crisis interfering with the patient's ability to secure food, transportation, or medication;</text> </paragraph> <paragraph num="(viii)"> <text>Extended or frequent hospitalizations;</text> </paragraph> <paragraph num="(ix)"> <text>Marked deterioration in health status or in functional status; or</text> </paragraph> <paragraph num="(x)"> <text>Situations that would warrant social work intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The social worker's progress notes shall contain, at a minimum:</text> <paragraph num="(a)"> <text>Documentation of the patient's adjustment to dialysis;</text> </paragraph> <paragraph num="(b)"> <text>Patient behaviors that may warrant discharge;</text> </paragraph> <paragraph num="(c)"> <text>Any referrals made to outside agencies; and</text> </paragraph> <paragraph num="(d)"> <text>Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The social worker shall:</text> <paragraph num="(a)"> <text>Recommend changes in treatment based on the patient's psychosocial needs;</text> </paragraph> <paragraph num="(b)"> <text>Provide case work and group work services to patients and their families in dealing with the special problems associated with end stage kidney disease;</text> </paragraph> <paragraph num="(c)"> <text>Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and</text> </paragraph> <paragraph num="(d)"> <text>Participate in continuous quality improvement activities and patient care planning.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Nocturnal Hemodialysis Programs."> <paragraph num="A."> <text>Nephrologist.</text> <paragraph num="(1)"> <text>The director of a freestanding dialysis facility shall be a nephrologist with at least 1 year of experience in chronic hemodialysis.</text> </paragraph> <paragraph num="(2)"> <text>A freestanding dialysis facility shall have at least one additional nephrologist trained in dialysis techniques to provide adequate continuous coverage.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director.</text> <paragraph num="(1)"> <text>A freestanding dialysis facility shall appoint a medical director.</text> </paragraph> <paragraph num="(2)"> <text>The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics.</text> </paragraph> <paragraph num="(3)"> <text>The medical director shall:</text> <paragraph num="(a)"> <text>Assure that the facility has documented eligibility criteria for the nocturnal dialysis patient;</text> </paragraph> <paragraph num="(b)"> <text>Determine the patient’s appropriateness and suitability for nocturnal hemodialysis by considering and documenting the patient’s:</text> <paragraph num="(i)"> <text>Overall medical condition, including whether the patient is hemodynamically stable;</text> </paragraph> <paragraph num="(ii)"> <text>Expectations for care;</text> </paragraph> <paragraph num="(iii)"> <text>Response to in-center, daytime hemodialysis; and</text> </paragraph> <paragraph num="(iv)"> <text>Availability of transportation;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care;</text> </paragraph> <paragraph num="(d)"> <text>Assure that an order from a nephrologist, nurse practitioner, or physician assistant for nocturnal hemodialysis is written;</text> </paragraph> <paragraph num="(e)"> <text>Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift;</text> </paragraph> <paragraph num="(f)"> <text>Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;</text> </paragraph> <paragraph num="(g)"> <text>Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures;</text> </paragraph> <paragraph num="(h)"> <text>Coordinate the comprehensive kidney health care team to assure quality of care;</text> </paragraph> <paragraph num="(i)"> <text>Assure there are written policies which address plans to select the appropriate end-stage kidney disease modality;</text> </paragraph> <paragraph num="(j)"> <text>Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility;</text> </paragraph> <paragraph num="(k)"> <text>Assure that the end-stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;</text> </paragraph> <paragraph num="(l)"> <text>Assure the appropriate execution of the dialysis orders and day-to-day patient care policy by the nursing and technical staff;</text> </paragraph> <paragraph num="(m)"> <text>Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;</text> </paragraph> <paragraph num="(n)"> <text>Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;</text> </paragraph> <paragraph num="(o)"> <text>Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;</text> </paragraph> <paragraph num="(p)"> <text>Supervise the development of a dialysis water standards policy, including implementation, monitoring, and enforcement;</text> </paragraph> <paragraph num="(q)"> <text>Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;</text> </paragraph> <paragraph num="(r)"> <text>Supervise the development of freestanding dialysis policies on the administration of intradialytic medications;</text> </paragraph> <paragraph num="(s)"> <text>Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;</text> </paragraph> <paragraph num="(t)"> <text>Assure that there are written policies regarding patient care and facility personnel organization;</text> </paragraph> <paragraph num="(u)"> <text>Assure that there are written policies regarding patient education;</text> </paragraph> <paragraph num="(v)"> <text>Assure that there are written policies regarding medical staff bylaws and licensed and certified staff credentialing;</text> </paragraph> <paragraph num="(w)"> <text>Assure that there are written freestanding dialysis policies for:</text> <paragraph num="(i)"> <text>Anemia management;</text> </paragraph> <paragraph num="(ii)"> <text>Adequacy of dialysis measures;</text> </paragraph> <paragraph num="(iii)"> <text>Dialysis water standards;</text> </paragraph> <paragraph num="(iv)"> <text>Immunization guidelines for Hepatitis B, influenza, pneumococcal, and any other applicable vaccines;</text> </paragraph> <paragraph num="(v)"> <text>Use of Vitamin D analogues; and</text> </paragraph> <paragraph num="(vi)"> <text>Monitoring parameters associated with the development of kidney osteodystrophy;</text> </paragraph> </paragraph> <paragraph num="(x)"> <text>Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program;</text> </paragraph> <paragraph num="(y)"> <text>Assure attending physicians and any other licensed or certified personnel comply with State and federal mandates applicable to the freestanding dialysis facility;</text> </paragraph> <paragraph num="(z)"> <text>Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and</text> </paragraph> <paragraph num="(aa)"> <text>Establish documented practice goals within the freestanding dialysis facility, which should assure optimal patient care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Nursing Services.</text> <paragraph num="(1)"> <text>Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who:</text> <paragraph num="(a)"> <text>Is a full-time employee of the facility;</text> </paragraph> <paragraph num="(b)"> <text>Is a registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>Has at least:</text> <paragraph num="(i)"> <text>12 months of experience in clinical nursing; and</text> </paragraph> <paragraph num="(ii)"> <text>An additional 6 months of experience in providing nursing care to patients on maintenance dialysis; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Participates in the facility's Quality Assessment and Performance Improvement Program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charge Nurse. The charge nurse responsible for each shift shall:</text> <paragraph num="(a)"> <text>Be a registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Be on duty in the treatment area at all times when patients are being treated, except for while on breaks when the charge nurse shall be readily available; and</text> </paragraph> <paragraph num="(c)"> <text>Have at least 12 months of experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Direct Patient Care Providers.</text> <paragraph num="(1)"> <text>Staffing Ratio.</text> <paragraph num="(a)"> <text>Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis:</text> <paragraph num="(i)"> <text>Shall be a minimum of one staff member to five participants; and</text> </paragraph> <paragraph num="(ii)"> <text>May be sufficient to meet the needs of the patients.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.</text> </paragraph> <paragraph num="(c)"> <text>The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A monitoring individual shall:</text> <paragraph num="(a)"> <text>Be trained in dialysis procedures and may be a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(iii)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(iv)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(v)"> <text>Licensed practical nurse; or</text> </paragraph> <paragraph num="(vi)"> <text>Certified nursing assistant—dialysis technician; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide direct patient care during treatment, which shall include, at a minimum:</text> <paragraph num="(i)"> <text>Initiation of treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Termination of treatment; and</text> </paragraph> <paragraph num="(iii)"> <text>Monitoring vital signs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.</text> </paragraph> <paragraph num="F."> <text>The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.</text> </paragraph> <paragraph num="G."> <text>Psychiatric services may be obtained by referral to a licensed psychiatrist.</text> </paragraph> <paragraph num="H."> <text>Social Worker.</text> <paragraph num="(1)"> <text>The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.</text> </paragraph> <paragraph num="(2)"> <text>Annual Psychosocial Update.</text> <paragraph num="(a)"> <text>A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.</text> </paragraph> <paragraph num="(b)"> <text>The annual psychosocial update shall include, at a minimum, the following issues:</text> <paragraph num="(i)"> <text>Review of treatment options;</text> </paragraph> <paragraph num="(ii)"> <text>Vocational rehabilitation;</text> </paragraph> <paragraph num="(iii)"> <text>Adjustment to illness issues;</text> </paragraph> <paragraph num="(iv)"> <text>Patient behaviors that may warrant discharge; and</text> </paragraph> <paragraph num="(v)"> <text>Any changes in the patient's relationships, living situation, and living wills.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The annual psychosocial update may be included with the mandatory quarterly documentation for psychosocially stable patients.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The social worker shall document progress notes:</text> <paragraph num="(a)"> <text>At least quarterly for stable patients; and</text> </paragraph> <paragraph num="(b)"> <text>At least monthly or more frequently for unstable patients, including but not limited to, patients experiencing:</text> <paragraph num="(i)"> <text>Adult Protective Services or Child Protective Services involvement;</text> </paragraph> <paragraph num="(ii)"> <text>Housing crisis or change;</text> </paragraph> <paragraph num="(iii)"> <text>Change in support system if patient is a vulnerable adult or child;</text> </paragraph> <paragraph num="(iv)"> <text>Violent or abusive behaviors or events;</text> </paragraph> <paragraph num="(v)"> <text>Emotional or psychological crisis including suicidal tendencies or emotional distress;</text> </paragraph> <paragraph num="(vi)"> <text>Death or major illness in the family;</text> </paragraph> <paragraph num="(vii)"> <text>Financial crisis interfering with the patient's ability to secure food, transportation, or medication;</text> </paragraph> <paragraph num="(viii)"> <text>Extended or frequent hospitalizations;</text> </paragraph> <paragraph num="(ix)"> <text>Marked deterioration in health status or in functional status; or</text> </paragraph> <paragraph num="(x)"> <text>Situations that would warrant social work intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The social worker's progress notes shall contain, at a minimum:</text> <paragraph num="(a)"> <text>Documentation of the patient's adjustment to dialysis;</text> </paragraph> <paragraph num="(b)"> <text>Patient behaviors that may warrant discharge;</text> </paragraph> <paragraph num="(c)"> <text>Any referrals made to outside agencies; and</text> </paragraph> <paragraph num="(d)"> <text>Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The social worker shall:</text> <paragraph num="(a)"> <text>Recommend changes in treatment based on the patient's psychosocial needs;</text> </paragraph> <paragraph num="(b)"> <text>Provide case work and group work services to patients and their families in dealing with the special problems associated with end-stage kidney disease;</text> </paragraph> <paragraph num="(c)"> <text>Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and</text> </paragraph> <paragraph num="(d)"> <text>Participate in continuous quality improvement activities and patient care planning.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Home Dialysis Programs."> <paragraph num="A."> <text>Location and Program Affiliation.</text> <paragraph num="(1)"> <text>Home hemodialysis or peritoneal dialysis programs, or both, may be situated in either a dialysis facility or hospital, as long as the appropriate standards are satisfied.</text> </paragraph> <paragraph num="(2)"> <text>To assure quality and continuity of patient care, the home dialysis program shall negotiate a formal affiliation agreement compliant with this subtitle.</text> </paragraph> <paragraph num="(3)"> <text>The home dialysis program shall be affiliated with a certified transplantation center.</text> </paragraph> <paragraph num="(4)"> <text>Home dialysis programs shall provide sufficient backup dialysis stations through specific affiliation agreements with certified dialysis facilities.</text> </paragraph> <paragraph num="(5)"> <text>Home dialysis training performed by dialysis centers or facilities shall also meet the standards established in this regulation.</text> </paragraph> <paragraph num="(6)"> <text>Home dialysis programs shall make arrangements for appropriate medical records, patient care policies, dietetic services, social services, sanitation standards, and fire and safety standards.</text> </paragraph> <paragraph num="(7)"> <text>Patients dialyzing at home shall keep records of dialysis treatments and supplies used.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Physical and Medical Standards.</text> <paragraph num="(1)"> <text>Home dialysis programs shall:</text> <paragraph num="(a)"> <text>Contain a dialysis station for training with either beds or chairs;</text> </paragraph> <paragraph num="(b)"> <text>Contain floor space that assures usable space of at least 80 square feet of floor space per patient station that may include bed or chair space, nursing space, and work area, but excludes storage space;</text> </paragraph> <paragraph num="(c)"> <text>Contain space to be sufficiently flexible to provide access to any of the four extremities;</text> </paragraph> <paragraph num="(d)"> <text>Provide appropriate provisions to assure patient privacy;</text> </paragraph> <paragraph num="(e)"> <text>Provide refrigerated and nonrefrigerated storage space;</text> </paragraph> <paragraph num="(f)"> <text>Provide sufficient area and space for:</text> <paragraph num="(i)"> <text>Maintenance of equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Storage of the equipment and supplies; and</text> </paragraph> <paragraph num="(iii)"> <text>Preparing and testing dialyzers;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Utilize water of sufficient purity to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements; and</text> </paragraph> <paragraph num="(h)"> <text>Provide adequate backup center dialysis.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Training.</text> <paragraph num="(a)"> <text>The home dialysis program shall maintain a written training manual and program that shall be available and approved by the Commission.</text> </paragraph> <paragraph num="(b)"> <text>The home dialysis program shall have patient training manuals available for patient utilization at times other than the dialysis procedure.</text> </paragraph> <paragraph num="(c)"> <text>The home dialysis program shall provide visual aids to complement instructional programs.</text> </paragraph> <paragraph num="(d)"> <text>It is generally accepted that training periods will vary depending on the needs of the patient and on the intensity and planning of the program.</text> </paragraph> <paragraph num="(e)"> <text>The training program shall also test the availability and purity of the water supply in the patient's home before home hemodialysis is instituted.</text> </paragraph> <paragraph num="(f)"> <text>The Commission shall review the training manual and program to determine if the length of training time is sufficient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Nephrologist and Additional Licensed Staff.</text> <paragraph num="(a)"> <text>The director of the home dialysis program shall be a nephrologist with at least 1 year of experience in chronic dialysis including experience in home dialysis training.</text> </paragraph> <paragraph num="(b)"> <text>One additional nephrologist, physician’s assistant, or certified registered nurse practitioner trained in dialysis shall be available to provide adequate continuous coverage.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medical Director. A home dialysis program shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Additional Home Dialysis Program Requirements.</text> <paragraph num="(a)"> <text>Home dialysis programs shall maintain a minimum nursing staff requirement of one nurse per two training stations.</text> </paragraph> <paragraph num="(b)"> <text>The nurse in charge of training shall have at least 12 months experience in providing nursing care including 6 months of experience in dialysis and 3 months of experience in the specific modality for which the nurse will provide self-care training.</text> </paragraph> <paragraph num="(c)"> <text>Technical assistance by qualified personnel shall be available for the repair and maintenance of dialysis equipment in the home dialysis program and homes.</text> </paragraph> <paragraph num="(d)"> <text>Home dialysis programs shall assure that adequate personnel are available to provide periodic follow-up home visits to patients on home dialysis programs.</text> </paragraph> <paragraph num="(e)"> <text>The training programs shall have adequate social services and dietetic staffing by licensed and trained professionals.</text> </paragraph> <paragraph num="(f)"> <text>Psychiatric services may be obtained by referral to a licensed psychiatrist.</text> </paragraph> <paragraph num="(g)"> <text>In dialysis programs providing home dialysis training, dialysis personnel responsible for staffing the dialysis programs may participate in home dialysis training as long as the staffing ratio standards are met.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04H of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Administration.</text> <paragraph num="(1)"> <text>The administration of the home dialysis program shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.</text> </paragraph> <paragraph num="(2)"> <text>The home dialysis program shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Compliance. Home dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Self-Care Dialysis Facilities."> <paragraph num="A."> <text>Location and Program Affiliation.</text> <paragraph num="(1)"> <text>Self-care dialysis facilities may be situated in free-standing dialysis facilities as long as appropriate standards are satisfied.</text> </paragraph> <paragraph num="(2)"> <text>To assure quality and continuity of patient care, including backup dialysis, the self-care dialysis facility or a hospital shall negotiate a formal affiliation agreement compliant with this subtitle.</text> </paragraph> <paragraph num="(3)"> <text>Self-care dialysis facilities shall make arrangements for appropriate medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in federal regulations for Medicare Programs and those of the Commission.</text> </paragraph> <paragraph num="(4)"> <text>Self-care dialysis facilities shall keep records of dialysis frequency and other factors relating to cost determination.</text> </paragraph> <paragraph num="(5)"> <text>For the purpose of protecting patient safety and welfare, a self-care dialysis facility may not withdraw or phase out services until:</text> <paragraph num="(a)"> <text>The self-care dialysis facility has notified the Commission as soon as possible of the self-care dialysis facility's intention to discontinue services;</text> </paragraph> <paragraph num="(b)"> <text>Patients being treated by that self-care dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patients and the Commission;</text> </paragraph> <paragraph num="(c)"> <text>The self-care dialysis facility submits to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and</text> </paragraph> <paragraph num="(d)"> <text>Patients previously certified and being treated in a self-care dialysis facility that is being withdrawn from the Kidney Disease Program continue to have access to the same reimbursement principles of the Kidney Disease Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Physical Standards.</text> <paragraph num="(1)"> <text>A self-care dialysis facility shall:</text> <paragraph num="(a)"> <text>Make available adequate floor space that may include bed or chair space, nursing space, and work area, but excludes storage space;</text> </paragraph> <paragraph num="(b)"> <text>Arrange the space to be sufficiently flexible to provide access to any of the four extremities;</text> </paragraph> <paragraph num="(c)"> <text>Provide patient privacy and comfort;</text> </paragraph> <paragraph num="(d)"> <text>Provide refrigerated and nonrefrigerated storage space;</text> </paragraph> <paragraph num="(e)"> <text>Provide sufficient work area and space for:</text> <paragraph num="(i)"> <text>Maintenance of equipment;</text> </paragraph> <paragraph num="(ii)"> <text>Storage of equipment and supplies; and</text> </paragraph> <paragraph num="(iii)"> <text>Preparing and testing dialyzers; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation recommendations which are incorporated by reference in this subtitle to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements in patients undergoing long-term dialysis.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Training. Self-care dialysis facilities shall provide training that includes:</text> <paragraph num="(a)"> <text>Visual aids to complement the instructional program; and</text> </paragraph> <paragraph num="(b)"> <text>Training periods that vary depending on the various needs of the patient and training program of the self-care dialysis facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Nephrologist and Additional Licensed Staff.</text> <paragraph num="(a)"> <text>The director of the self-care dialysis facility shall be a nephrologist with at least 1 year of experience in chronic dialysis.</text> </paragraph> <paragraph num="(b)"> <text>At least one additional nephrologist, physician’s assistant, or certified registered nurse practitioner trained in dialysis shall be available to provide adequate continuous coverage.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medical Director. A self-care dialysis facility shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Additional Self-Care Dialysis Facilities Requirements.</text> <paragraph num="(a)"> <text>Direct patient care providers shall be trained in dialysis procedures and may be a:</text> <paragraph num="(i)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed practical nurse; or</text> </paragraph> <paragraph num="(iii)"> <text>Certified nursing assistant—dialysis technician.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A charge nurse:</text> <paragraph num="(i)"> <text>Shall be a registered nurse;</text> </paragraph> <paragraph num="(ii)"> <text>Shall be on duty in the treatment area, except for while on breaks, when the charge nurse shall be readily available, at all times when patients are being treated;</text> </paragraph> <paragraph num="(iii)"> <text>Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and</text> </paragraph> <paragraph num="(iv)"> <text>May not be included in the staffing ratio except when there are nine or fewer patients or in the event of an emergency.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Staffing Exception Reporting. The facility shall have a staffing exception reporting protocol in a format approved by the Commission for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:</text> <paragraph num="(i)"> <text>The date and shift of the exception; and</text> </paragraph> <paragraph num="(ii)"> <text>A description of the emergency staffing situation.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Additional staffing may be achieved with the use of licensed practical nurses or certified nursing assistant—dialysis technicians.</text> </paragraph> <paragraph num="(e)"> <text>Supervisory nursing personnel, which includes the charge nurse, may not be included in the calculation of staff/patient ratio if the supervisory nursing personnel do not participate in the monitoring of dialysis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Technical assistance by qualified technicians shall be available for the repair and maintenance of equipment.</text> </paragraph> <paragraph num="(5)"> <text>In addition, the self-care dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.</text> </paragraph> <paragraph num="(6)"> <text>The self-care dialysis facility shall have psychiatric services available to patients by referral.</text> </paragraph> <paragraph num="(7)"> <text>Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04H of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Administration.</text> <paragraph num="(1)"> <text>The administration of the self-care dialysis facility shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.</text> </paragraph> <paragraph num="(2)"> <text>The self-care dialysis facility shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Compliance. Self-care dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2003 (30:25 Md. R. 1846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G adopted effective April 24, 2006 (33:8 Md. R. 733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 16, 2015 (42:5 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 18, 2025 (52:16 Md. R 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 18, 2025 (52:16 Md. R 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 18, 2025 (52:16 Md. R 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B, H amended effective August 18, 2025 (52:16 Md. R 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C, E amended effective August 18, 2025 (52:16 Md. R 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 18, 2025 (52:16 Md. R 846)</annotation> </annotations> </chapter> <chapter num="03" heading="Transmissible Diseases"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <text>Control of Communicable Diseases Manual which can be found in depository libraries under COMAR 10.06.01.01-1 is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Unrestricted Access to Care."> <paragraph num="A."> <text>An end stage kidney disease patient with any transmissible disease, may not be denied dialysis or transplantation by a certified Maryland dialysis or transplantation facility solely because of the potential for transmission of the transmissible disease, to other patients or treatment personnel.</text> </paragraph> <paragraph num="B."> <text>If tours of the dialysis facility take place, the facility shall inform visitors of the risk of transmissible disease exposure and encourage thorough hand washing at the end of the tour.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Preventive Measures."> <paragraph num="A."> <text>A facility shall follow the infection control procedures established in the Control of Communicable Diseases Manual designed by the Centers for Disease Control and Prevention (CDC) to control the spread of transmissible diseases.</text> </paragraph> <paragraph num="B."> <text>General.</text> <paragraph num="(1)"> <text>The cardinal measure for preventing the spread of transmissible diseases is an understanding on the part of dialysis and transplantation personnel that each end-stage kidney disease patient is potentially a transmitter of transmissible diseases.</text> </paragraph> <paragraph num="(2)"> <text>Hand Washing.</text> <paragraph num="(a)"> <text>Dialysis personnel shall practice thorough hand washing, per the Control of Communicable Diseases Manual, between successive contacts with dialysis patients.</text> </paragraph> <paragraph num="(b)"> <text>Dialysis facilities and transplant centers shall contain adequate hand washing facilities within the patient care area.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Dialysis facilities and transplant centers shall conduct an in-service training session for transmissible disease including hepatitis and the control of hepatitis for newly employed dialysis personnel before the dialysis personnel may participate in patient care, and at least annually for all dialysis personnel.</text> </paragraph> <paragraph num="(4)"> <text>Dialysis facilities and transplant centers shall establish and enforce written procedures to implement the control of transmissible disease including viral hepatitis as set forth in the Control of Communicable Diseases Manual.</text> </paragraph> <paragraph num="(5)"> <text>Hepatitis B vaccine is recognized to be effective in producing immunity and is recommended for all staff and patients who are susceptible to hepatitis B virus infection.</text> </paragraph> <paragraph num="(6)"> <text>Dialysis facilities and transplant centers shall document testing to demonstrate active immunity by appropriate antibody titers.</text> </paragraph> <paragraph num="(7)"> <text>Hepatitis testing shall be conducted on patients and staff according to the Control of Communicable Diseases Manual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control and Hygiene.</text> <paragraph num="(1)"> <text>To the extent possible, the dialysis facility shall physically separate, in time or space, patients who are antigen positive from those who are antigen negative.</text> </paragraph> <paragraph num="(2)"> <text>Dialysis personnel shall:</text> <paragraph num="(a)"> <text>Wear personal protective equipment (PPE) at all times while providing patient care in the treatment area;</text> </paragraph> <paragraph num="(b)"> <text>Be properly bandaged to prevent contact with blood or other bodily fluids, if dialysis personnel have lesions on any body parts;</text> </paragraph> <paragraph num="(c)"> <text>Wear PPE in activities and situations where contact with blood or other potentially infectious secretions may occur;</text> </paragraph> <paragraph num="(d)"> <text>Dispose of used gloves immediately upon completion of any procedure and practice thorough hand washing before any other patient contact;</text> </paragraph> <paragraph num="(e)"> <text>Take necessary precautions to avoid contact with contaminated surfaces and clothing and carefully clean contaminated surfaces with a suitable disinfectant immediately after the patient's dialysis session is ended; and</text> </paragraph> <paragraph num="(f)"> <text>Remove and dispose of station coverings immediately after the patient's dialysis session has ended and thoroughly sanitize the dialysis station.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A dialysis facility may not permit staff members or visitors to eat, drink, or smoke in the treatment area.</text> </paragraph> <paragraph num="(4)"> <text>A dialysis facility shall follow the advice of the Centers for Disease Control and Prevention (CDC) for staff immunization and surveillance for hepatitis B.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Disposal.</text> <paragraph num="(1)"> <text>Dialysis facilities shall assure that waste and disposable items are packaged or wrapped on the premises of the facility in plastic-lined containers which shall be clearly identified as possibly contaminated materials either by labels or color-coding.</text> </paragraph> <paragraph num="(2)"> <text>Before including used needles in the specially identified containers described in §D(1) of this regulation, dialysis personnel shall place these needles in separate, rigid containers.</text> </paragraph> <paragraph num="(3)"> <text>The dialysis facility shall incinerate or make arrangements for the incineration of the dialysis facility's waste in accordance with local, State, or federal regulations.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Decontamination. The dialysis facility shall assure that personnel place used linens, scrub clothes, gowns, and laboratory coats in transport bags clearly identified as possibly contaminated material either by labels or color-coding, and that:</text> <paragraph num="(1)"> <text>Individuals subsequently handling these materials are aware of potential contamination; and</text> </paragraph> <paragraph num="(2)"> <text>Specimens issuing from dialysis facilities are appropriately treated and identified as possibly contaminated material either by labels or color-coding.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Detection Measures."> <text>Dialysis facilities and transplant centers shall develop quality assessment and performance improvement (QAPI) measures for the surveillance of infection control practices.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2003 (30:25 Md. R. 1846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571); August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B, C amended effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> </annotations> </chapter> <chapter num="04" heading="Dialyzer Reuse and Water Standards"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>42 CFR §494.40, as amended; and</text> </paragraph> <paragraph num="(2)"> <text>42 CFR §494.50, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Water Standards — Water Treatment System — Dialysis Facilities."> <paragraph num="A."> <text>The dialysis facility shall record in a log system malfunctions or temporary failures to meet standards. Extended failure of 1 day or longer is unsuitable and out of compliance with these regulations.</text> </paragraph> <paragraph num="B."> <text>The dialysis facility shall report system malfunctions at once to:</text> <paragraph num="(1)"> <text>The Office of Health Care Quality of the Department;</text> </paragraph> <paragraph num="(2)"> <text>The supplier as to the unprotected state of the dialysis facility; and</text> </paragraph> <paragraph num="(3)"> <text>The Commission.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the freestanding dialysis facility experiences a water system failure that may threaten patient health or safety, the facility shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §494.40, which is incorporated by reference.</text> </paragraph> <paragraph num="D."> <text>Each freestanding dialysis facility shall communicate water treatment issues with their local health emergency management agency and their local health officer.</text> </paragraph> <paragraph num="E."> <text>Boiled Water Advisory.</text> <paragraph num="(1)"> <text>A facility may dialyze patients under a boiled water advisory if the water treatment components in use protect the product water from having chemical and microbial contamination.</text> </paragraph> <paragraph num="(2)"> <text>The facility shall have policies and procedures in place to identify the person responsible for monitoring the water quality and how often the treated water will be monitored.</text> </paragraph> <paragraph num="(3)"> <text>The medical director shall assure close monitoring of the product water under the boiled water advisory.</text> </paragraph> <paragraph num="(4)"> <text>If a deionization (DI) unit is being used as the main water treatment system, a submicron or endotoxin/ultrafilter downstream of the DI unit, diverted to the drain, shall be in place.</text> </paragraph> <paragraph num="(5)"> <text>If a deionization (DI) unit is being used as the main water treatment system:</text> <paragraph num="(a)"> <text>The deionization systems shall be monitored continuously:</text> <paragraph num="(i)"> <text>To produce water of one megohm/cm or greater specific resistivity; and</text> </paragraph> <paragraph num="(ii)"> <text>Using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms which are audible in the patient care area;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The audible and visible alarm shall be activated when the product water resistivity falls below 1.0 megohm/cm and the product water shall be prevented from reaching any point of use; and</text> </paragraph> <paragraph num="(c)"> <text>A submicron or endotoxin/ultrafilter downstream of the DI unit shall be in place.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If an ultraviolet (UV) irradiator is used, the ultrafilter shall be:</text> <paragraph num="(a)"> <text>Located after the UV irradiator; and</text> </paragraph> <paragraph num="(b)"> <text>Monitored to detect any decrease in treated water quality.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The facility shall perform weekly microbial assessment of the product water during the boiled water advisory.</text> </paragraph> <paragraph num="(8)"> <text>The facility shall maintain contact with the municipal water supplier in the event the water supplier chooses to “shock” treat (hyperchlorinate) the distribution system to bring it back into compliance with the acceptable standards for drinking water.</text> </paragraph> <paragraph num="(9)"> <text>The facility shall contact the municipal water supplier at least annually in writing to identify their location, contact information and the needs of the dialysis facility during any water service interruption.</text> </paragraph> <paragraph num="(10)"> <text>Shocking of Water System.</text> <paragraph num="(a)"> <text>In the event the municipal water supplier “shocks” the water system, chlorine/chloramine break through may occur. Water system testing procedures shall be reviewed with staff by the medical director to alert them for potential chlorine/chloramines break through so that patients will be protected from exposure to chlorine/chloramine.</text> </paragraph> <paragraph num="(b)"> <text>Every half-hour, the facility shall:</text> <paragraph num="(i)"> <text>Monitor the feed water for any increase in chlorine/chloramine; and</text> </paragraph> <paragraph num="(ii)"> <text>Test for chlorine/chloramine breakthrough after the first carbon filter.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The half-hour testing described in §E(10)(b) of this regulation shall continue until 24 hours after feed water results return to normal.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2003 (30:25 Md. R. 1846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended and recodified to Regulation .02 effective August 18, 2025 (52:16 Md. R. 846)</annotation> </annotations> </chapter> <chapter num="05" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs dialysis facilities and transplant centers, except those exempted by statute, that are certified by the Commission for eligibility for reimbursement by the Kidney Disease Program for performance of dialysis or transplantation on certified patients with end-stage renal disease.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following certification fees are established by the Commission and may be prorated for initial certification of a partial year:</text> <paragraph num="A."> <text>Facilities with 0 — 39 patients ... $693;</text> </paragraph> <paragraph num="B."> <text>Facilities with 40 — 49 patients ... $1,274;</text> </paragraph> <paragraph num="C."> <text>Facilities with 50 or more patients ... $1,500;</text> </paragraph> <paragraph num="D."> <text>Late fee ... 10 percent of fee; and</text> </paragraph> <paragraph num="E."> <text>Facility roster fee (fee may be waived for patients) ... $55.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Terms."> <paragraph num="A."> <text>A facility shall pay to the Commission the certification fees set forth in Regulation .02 of this chapter within 30 days of the date that they are billed.</text> </paragraph> <paragraph num="B."> <text>The Commission shall bill a facility within 30 days of the facility's certification or verification of the facility's certification by the Commission.</text> </paragraph> <paragraph num="C."> <text>Billing shall be done on an annual basis.</text> </paragraph> <paragraph num="D."> <text>The term of the certification is 1 year and is renewed on an annual basis.</text> </paragraph> <paragraph num="E."> <text>Initial certification is only for the term of the current certification year.</text> </paragraph> <paragraph num="F."> <text>A late fee of 10 percent of the assessed certification fee shall be charged in addition to the certification fee if payment is received more than 30 days after the due date.</text> </paragraph> <paragraph num="G."> <text>A facility that fails to pay the certification fee, plus the late fee, more than 60 days after the due date shall be decertified.</text> </paragraph> <paragraph num="H."> <text>The facility may not charge the patient for those fees which the Kidney Disease Program would have paid, had the facility complied with this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prohibitions."> <text>A facility or center may not receive funds from the Kidney Disease Program for certified services rendered, unless the facility is certified by the Commission and has paid in full the fee assessed it by the Commission in the time limit set forth by the Commission.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Fund Administration."> <text>The Chairman of the Commission or the Chairman's designee shall administer the Kidney Disease Fund as established under Health-General Article, §13-310.1, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 2003 (30:25 Md. R. 1846)</annotation> </annotations> </chapter> </subtitle> <subtitle num="31" heading="Health Occupation Boards"> <chapter num="01" heading="Code of Conduct for Board Members and Investigators"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes a code of conduct for members of health occupation boards within the Maryland Department of Health and for investigators employed by the health occupation boards.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to the Board of Nursing. The Board of Nursing's Code of Conduct regulations are set forth in COMAR 10.27.23.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means a health occupation board regulated under the Health Occupations Article or the Health-General Article, Annotated Code of Maryland, with the exception of the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Board member” means an individual appointed by the Governor to serve on a Board.</text> </paragraph> <paragraph num="(3)"> <text>“Charging document” means the notice from the board pursuant to State Government Article, §10-208, Annotated Code of Maryland, which informs a licensee of an alleged violation or violations of a board's statute by the licensee.</text> </paragraph> <paragraph num="(4)"> <text>“Complaint” means a communication to a board of a possible violation of the disciplinary provisions of a Maryland licensing statute by a licensee.</text> </paragraph> <paragraph num="(5)"> <text>“Conflict of interest” means a situation in which a personal interest of a board member or a board investigator presents a potential conflict with the public interest in connection with an anticipated public action or decision.</text> </paragraph> <paragraph num="(6)"> <text>“Ex parte communication” means a direct or indirect communication between a board member and another party regarding the merits of an issue in a pending contested disciplinary case if the communication is made outside the presence of the opposing party in the case.</text> </paragraph> <paragraph num="(7)"> <text>“Investigator” means an individual who investigates complaints received by a health occupation board.</text> </paragraph> <paragraph num="(8)"> <text>Liaison.</text> <paragraph num="(a)"> <text>“Liaison” means a board member designated by the board to provide practitioner expertise to the investigator or prosecutor, or both, pertaining to a specific complaint.</text> </paragraph> <paragraph num="(b)"> <text>“Liaison” does not mean a board member who participates only in a preliminary review of a complaint.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Recusal” means nonparticipation of a board member in a specific matter before the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Recusal of Board Members."> <paragraph num="A."> <text>Standards for Recusal.</text> <paragraph num="(1)"> <text>A Board member shall recuse himself or herself from board proceedings which involve situations in which the board member:</text> <paragraph num="(a)"> <text>Has a conflict of interest; or</text> </paragraph> <paragraph num="(b)"> <text>Cannot participate fairly and impartially.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Personal familiarity with a respondent does not, of itself, require recusal of a board member.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Board Counsel Advice. A board member may seek the advice of the board's counsel in determining the need for recusal on a specific matter.</text> </paragraph> <paragraph num="C."> <text>Requirements Following Recusal.</text> <paragraph num="(1)"> <text>The board member who is recused from a matter before the board may not:</text> <paragraph num="(a)"> <text>Participate in the board's discussion or vote on the matter; or</text> </paragraph> <paragraph num="(b)"> <text>Discuss the matter with other members of the board or discuss the board's review of the matter with other individuals.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the matter before the board is a disciplinary matter, the board member who is recused shall physically leave the room to ensure nonparticipation.</text> </paragraph> <paragraph num="(3)"> <text>The board shall document the recusal of the board member in the minutes of the board meeting.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Complaint Against a Board Member.</text> <paragraph num="(1)"> <text>A board member against whom a complaint is filed shall follow §C of this regulation for all discussion and voting concerning the complaint filed against the board member.</text> </paragraph> <paragraph num="(2)"> <text>If the board determines that there is an additional matter before the board which is reasonably related to the complaint filed against the board member, the board member against whom the complaint is filed shall follow §C of this regulation for the additional matter also.</text> </paragraph> <paragraph num="(3)"> <text>If, after investigation of the complaint, the board refers the case to the Attorney General's Office, the board member shall recuse himself or herself from all board activities until the final disposition of the case.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Liaison.</text> <paragraph num="(1)"> <text>A board member may not serve as a liaison on a complaint in which the board member has a conflict of interest.</text> </paragraph> <paragraph num="(2)"> <text>A board member who serves as the liaison on a specific complaint may:</text> <paragraph num="(a)"> <text>Participate in discussion of the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Vote on the decision regarding charges based on the complaint; and</text> </paragraph> <paragraph num="(c)"> <text>Participate in the case resolution conference for the complaint.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A board member who serves as the liaison on a specific complaint may not:</text> <paragraph num="(a)"> <text>Participate in a hearing on the complaint conducted by the board; or</text> </paragraph> <paragraph num="(b)"> <text>Participate in the discussion or vote on the complaint following the hearing conducted either by the board or by the Office of Administrative Hearings (OAH) through authority delegated from the board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Investigator."> <paragraph num="A."> <text>An investigator may not conduct or participate in an investigation of a complaint in which the investigator has a conflict of interest.</text> </paragraph> <paragraph num="B."> <text>In the investigation of a complaint against a member of a board, the board may consider using an investigator other than the one who is regularly assigned to conduct investigations for the board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Confidentiality."> <paragraph num="A."> <text>A board member or investigator may not discuss disciplinary or other confidential matters with an individual other than:</text> <paragraph num="(1)"> <text>A board member;</text> </paragraph> <paragraph num="(2)"> <text>Board staff;</text> </paragraph> <paragraph num="(3)"> <text>The Attorney General's Office;</text> </paragraph> <paragraph num="(4)"> <text>A witness; or</text> </paragraph> <paragraph num="(5)"> <text>Another individual authorized by law to be involved in the case.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the case of an ex parte communication, the board member shall follow the provisions of State Government Article, §10-219, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104; Health Occupations Article, §§1-203, 1A-205, 2-205, 3-205, 4-205, 5-205, 6-206, 7-205, 9-205, 10-205, 11-205, 12-205, 13-206, 14-205, 16-205, 17-205, 18-206, 19-205, 20-205 and 21-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 24, 2000 (27:14 Md. R. 1341)</annotation> </annotations> </chapter> <chapter num="02" heading="Tax Compliance Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means a health occupation board regulated under the Health Occupations Article, Annotated Code of Maryland, with the exception of the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Delinquent” means the failure by a certificate holder, licensee, registration holder, or permit holder, to pay all undisputed taxes and unemployment insurance contributions, as determined by the Office of the Comptroller or the Secretary of Labor, that are payable to the Office of the Comptroller or the Secretary of Labor, in a manner satisfactory to the unit of the State responsible for collection of the payment.</text> </paragraph> <paragraph num="(3)"> <text>“Renewal license” means any license, permit, certification, or registration granted by the Board for the period immediately following a period for which the person previously possessed the same or a substantially similar license, permit, certification, or registration.</text> </paragraph> <paragraph num="(4)"> <text>“Verification” means a written or electronic notification created by the unit of the State responsible for collection of taxes or unemployment insurance contributions attesting that the renewal applicant is no longer delinquent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Outstanding Taxes or Unemployment Insurance Contributions."> <paragraph num="A."> <text>If a renewal applicant has been identified as delinquent by the Office of the Comptroller or the Maryland Department of Labor, the Board shall issue a written notice to the renewal applicant stating that:</text> <paragraph num="(1)"> <text>The renewal applicant has been identified by the Office of the Comptroller or the Maryland Department of Labor, as delinquent in the payment of taxes or unemployment insurance contributions as applicable; and</text> </paragraph> <paragraph num="(2)"> <text>The renewal license will be denied if a verification is not submitted to the Board within 30 days after the notice is issued or before the expiration date of the current certificate, license, registration, or permit, whichever is later.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board does not receive a verification within 30 days after the Board issued the notice or before the expiration date of the current certificate, license, registration, or permit, whichever is later, the Board shall:</text> <paragraph num="(1)"> <text>Deny the renewal license; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the renewal applicant in writing that the renewal license has been denied.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1A-205, 2-205, 3-205, 4-205, 5-205, 7-205, 8-205, 9-205,10-205, 11-205, 12-205, 13-206, 14-205, 16-205, 17-205, 18-206, and 19-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective July 1, 2003 (30:19 Md. R. 1327); adopted permanently effective December 11, 2003 (30:24 Md. R. 1741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 15, 2004 (31:5 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 12, 2018 (45:5 Md. R. 286)</annotation> </annotations> </chapter> </subtitle> <subtitle num="32" heading="Board of Physicians"> <chapter num="01" heading="General Licensure Regulations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern how an individual becomes licensed in Maryland to practice medicine.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ABMS” means the American Board of Medical Specialties.</text> </paragraph> <paragraph num="(2)"> <text>“ACCME” means the Accreditation Council on Continuing Medical Education.</text> </paragraph> <paragraph num="(3)"> <text>“ACGME” means the Accreditation Council for Graduate Medical Education.</text> </paragraph> <paragraph num="(4)"> <text>“Accredited training program” means a postgraduate clinical medical education program which is:</text> <paragraph num="(a)"> <text>Certified by the:</text> <paragraph num="(i)"> <text>Accreditation Council for Graduate Medical Education (ACGME) or its successor; or</text> </paragraph> <paragraph num="(ii)"> <text>American Osteopathic Association (AOA) or its successor;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Accredited by the Royal College of Physicians and Surgeons of Canada (RCPSC) or its successor;</text> </paragraph> <paragraph num="(c)"> <text>A postgraduate clinical medical education program that meets all of the following criteria:</text> <paragraph num="(i)"> <text>Is in a specialty or subspecialty area, or both, that is not being accredited by the ACGME, AOA or RCPSC but meets all the requirements for accreditation of Accreditation Council for Graduate Medical Education, the American Osteopathic Association, or the Royal College of Physicians and Surgeons of Canada;</text> </paragraph> <paragraph num="(ii)"> <text>Is directed by a physician who is actively licensed to practice medicine in the United States, its territories or possessions, Puerto Rico, or Canada;</text> </paragraph> <paragraph num="(iii)"> <text>Is concurrently offered with ACGME-accredited programs; and</text> </paragraph> <paragraph num="(iv)"> <text>Is taught at a hospital that is accredited by The Joint Commission or its successor or predecessor; or</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A program conducted in the United States of America or Canada that is the equivalent of §B(3)(a), (b), or (c) of this regulation as determined by the Board of Physicians.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“AOA” means the American Osteopathic Association.</text> </paragraph> <paragraph num="(6)"> <text>“Applicant” means an individual applying for initial licensure as a physician in Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Application period” means the time between the Board's receipt of an application and the issuance of a license or the closure of an application through withdrawal, determination of ineligibility, or denial of application.</text> </paragraph> <paragraph num="(8)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(9)"> <text>“Board-certified” means the physician is certified by a public or private board, including a multidisciplinary board, and the certifying board is:</text> <paragraph num="(a)"> <text>A member of ABMS;</text> </paragraph> <paragraph num="(b)"> <text>An AOA certifying board;</text> </paragraph> <paragraph num="(c)"> <text>The Royal College of Physicians and Surgeons of Canada; or</text> </paragraph> <paragraph num="(d)"> <text>The College of Family Physicians of Canada.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“CME” means continuing medical education.</text> </paragraph> <paragraph num="(11)"> <text>“ECFMG” means the Educational Commission for Foreign Medical Graduates or its successor.</text> </paragraph> <paragraph num="(12)"> <text>“FCVS” means the Federal Credentialing Verification Services of the Federation of State Medical Boards of the United States, Inc.</text> </paragraph> <paragraph num="(13)"> <text>“Federation” means the Federation of State Medical Boards of the United States, Inc.</text> </paragraph> <paragraph num="(14)"> <text>“FLEX examination” means the Federation Licensing Examination designed by the Federation of State Medical Boards in cooperation with the National Board of Medical Examiners.</text> </paragraph> <paragraph num="(15)"> <text>“FLEX weighted average” means the method of calculating the grade of the FLEX examination by which the test results on the first day count 1/6, the second day 2/6, and the third day 3/6.</text> </paragraph> <paragraph num="(16)"> <text>“Foreign medical school” means a medical school located outside the United States or its territories, Canada, or Puerto Rico.</text> </paragraph> <paragraph num="(17)"> <text>“LCME” means Liaison Committee on Medical Education, an organization that accredits programs in medical education leading to the doctor of medicine degree in the United States and territories and, in cooperation with the Committee on Accreditation of Canadian Medical Schools, in Canada.</text> </paragraph> <paragraph num="(18)"> <text>“Oral Proficiency Interview (OPI)” means the examination of the American Council on the Teaching of Foreign Languages designed to evaluate the spoken English proficiency of those whose native language is not English.</text> </paragraph> <paragraph num="(19)"> <text>"Orientation program” means a program of information approved by the Board which includes:</text> <paragraph num="(a)"> <text>The statutes and regulations governing the practice of medicine in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Boundary issues; and</text> </paragraph> <paragraph num="(c)"> <text>The role and functions of the Board.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Postgraduate training” means clinical and medical training for medical school graduates, including but not limited to, internships, residencies, and fellowships.</text> </paragraph> <paragraph num="(21)"> <text>“Professional school” means a school whose curricula lead to a professional license, certification, or registration issued under the Health Occupations Article, Annotated Code of Maryland, including the medical school of graduation or the medical school, where an applicant obtained medical education, that is affiliated with the institution that conferred the medical degree on the applicant.</text> </paragraph> <paragraph num="(22)"> <text>“Recertification” means successfully meeting all of the specified recertification requirements of a medical licensing authority or specialty board recognized by the Board.</text> </paragraph> <paragraph num="(23)"> <text>“Speech impairment” means a disorder of the voice, articulation, speech sounds, or fluency in the speaker's native language.</text> </paragraph> <paragraph num="(24)"> <text>“SPEX” means the Special Purpose Examination prepared by the Federation of State Medical Boards.</text> </paragraph> <paragraph num="(25)"> <text>“Successfully completed year of postgraduate training” means:</text> <paragraph num="(a)"> <text>12 months of accredited postgraduate training in one integrated program in which the:</text> <paragraph num="(i)"> <text>Applicant completed all the requirements;</text> </paragraph> <paragraph num="(ii)"> <text>Program director rated the applicant's performance as satisfactory; and</text> </paragraph> <paragraph num="(iii)"> <text>Applicant's performance was such that the applicant qualified for advancement without academic or clinical probationary conditions to the next year and next progressive level of responsibility in a designated specialty program; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A year of accredited postgraduate training which the applicant completed in a manner that satisfied the requirements of §B(20-1)(a)(i) and (ii) of this regulation but that did not satisfy the requirements of §B(20-1)(a)(iii) of this regulation, and which was followed by a year of training which the applicant completed in a manner that satisfied all of the requirements of §B(20-1)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“TOEFL” means the Test of English as a Foreign Language.</text> </paragraph> <paragraph num="(27)"> <text>“USMLE” means the United States Medical Licensing Examination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure — Qualifications for Initial Licensure."> <paragraph num="A."> <text>Moral Character. The applicant shall be of good moral character.</text> </paragraph> <paragraph num="B."> <text>Age. The applicant shall be 18 years old or older.</text> </paragraph> <paragraph num="C."> <text>Fee. An applicant for initial licensure shall pay the initial application fee and any additional charges set by the Board.</text> </paragraph> <paragraph num="D."> <text>Education and Training. The applicant shall meet at least one of the following requirements:</text> <paragraph num="(1)"> <text>Have a doctor of medicine degree from a school of medicine accredited by LCME at the time of the applicant's graduation and have successfully completed 1 year of postgraduate training at an accredited training program;</text> </paragraph> <paragraph num="(2)"> <text>Have a doctor of osteopathy degree from a school of osteopathy in the United States, its territories or possessions, Puerto Rico, or Canada that has standards for graduation equivalent to those established by the American Osteopathic Association (AOA) and have successfully completed 1 year of postgraduate training at an accredited training program;</text> </paragraph> <paragraph num="(3)"> <text>Have a doctor of medicine degree from any other medical school, have successfully completed the requirements for and obtained ECFMG certification, and have successfully completed 2 years of post-graduate training at an accredited training program; or</text> </paragraph> <paragraph num="(4)"> <text>Have a document stating that the applicant has successfully completed a fifth pathway program as defined in Health Occupations Article, §14-308(a)(2), Annotated Code of Maryland, have successfully completed all of the formal graduation requirements of a foreign medical school except for the postgraduate or social service components as required by the foreign country or its medical school, and have successfully completed 2 years of postgraduate training at an accredited training program.</text> </paragraph> </paragraph> <paragraph num="E."> <text>On a case-by-case basis, the Board may consider full-time teaching in an LCME-accredited medical school in the United States as an alternative to the accredited postgraduate clinical medical education programs required in §D of this regulation.</text> </paragraph> <paragraph num="F."> <text>The Board may consider practice in another state of the United States or in Canada as an alternative to the accredited postgraduate clinical medical education program required in §D of this regulation if:</text> <paragraph num="(1)"> <text>There is a minimum of 10 years clinical practice in the United States or Canada, with 3 years being within 5 years of the date of the application; and</text> </paragraph> <paragraph num="(2)"> <text>The clinical practice occurred under a full unrestricted license to practice medicine.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Examination.</text> <paragraph num="(1)"> <text>An applicant for licensure in Maryland shall successfully complete at least one of the following examination requirements:</text> <paragraph num="(a)"> <text>Achieve a passing score on all parts of the National Board of Medical Examiners examination as evidenced by an endorsement of certification issued by the National Board of Medical Examiners;</text> </paragraph> <paragraph num="(b)"> <text>Achieve a score as follows:</text> <paragraph num="(i)"> <text>At least 75 on each part of the FLEX examination;</text> </paragraph> <paragraph num="(ii)"> <text>A FLEX weighted average score of at least 75 on a FLEX examination taken before 1985 and achieved in one sitting; or</text> </paragraph> <paragraph num="(iii)"> <text>A FLEX weighted average score of at least 75 on a FLEX examination taken before 1985 and be currently certified by a member board of the American Board of Medical Specialties;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Achieve a passing score, as evidenced by receipt of either a Diplomate Certification or a Certification of Completion issued by the National Board of Osteopathic Medical Examiners after January 1, 1971, on:</text> <paragraph num="(i)"> <text>All parts of the examination of the National Board of Osteopathic Medical Examiners (NBOME);</text> </paragraph> <paragraph num="(ii)"> <text>All levels of the Comprehensive Osteopathic Medical Licensing Examination (COMLEX); or</text> </paragraph> <paragraph num="(iii)"> <text>A combination of these examinations;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Achieve the recommended passing score on all levels of the Comprehensive Osteopathic Medical Licensing Exam of the National Board of Osteopathic Medical Examiners;</text> </paragraph> <paragraph num="(e)"> <text>Achieve passing scores on any of the following examination combinations:</text> <paragraph num="(i)"> <text>NBOME Part 1 + NBOME Part 2 + COMLEX Level 3;</text> </paragraph> <paragraph num="(ii)"> <text>NBOME Part 1 + COMLEX Level 2 + COMLEX Level 3;</text> </paragraph> <paragraph num="(iii)"> <text>NBOME Part 1 + COMLEX Level 2 + NBOME Part 3;</text> </paragraph> <paragraph num="(iv)"> <text>COMLEX Level 1 + NBOME Part 2 + NBOME Part 3;</text> </paragraph> <paragraph num="(v)"> <text>COMLEX Level 1 + COMLEX Level 2 + NBOME Part 3; or</text> </paragraph> <paragraph num="(vi)"> <text>COMLEX Level 1 + NBOME Part 2 + COMLEX Level 3;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Achieve a passing score on all parts of the examination of any state board or the District of Columbia Board of Medicine in the United States;</text> </paragraph> <paragraph num="(g)"> <text>Achieve a passing score on all steps of the United States Medical Licensing Examination (USMLE);</text> </paragraph> <paragraph num="(h)"> <text>If completed before the year 2000, achieve passing scores on any of the following examination combinations:</text> <paragraph num="(i)"> <text>USMLE Step 1 + NBME Part II + NBME Part III;</text> </paragraph> <paragraph num="(ii)"> <text>USMLE Step 1 + USMLE Step 2 + NBME Part III;</text> </paragraph> <paragraph num="(iii)"> <text>USMLE Step 1 + NBME Part II + USMLE Step 3;</text> </paragraph> <paragraph num="(iv)"> <text>NBME Part I + USMLE Step 2 + USMLE Step 3;</text> </paragraph> <paragraph num="(v)"> <text>NBME Part I + USMLE Step 2 + NBME Part III;</text> </paragraph> <paragraph num="(vi)"> <text>NBME Part I + NBME Part II + USMLE Step 3;</text> </paragraph> <paragraph num="(vii)"> <text>FLEX Component 1 + USMLE 3;</text> </paragraph> <paragraph num="(viii)"> <text>FLEX Component 2 + USMLE Step 1 + NBME Part II;</text> </paragraph> <paragraph num="(ix)"> <text>FLEX Component 2 + USMLE Step 1 + USMLE Step 2;</text> </paragraph> <paragraph num="(x)"> <text>FLEX Component 2 + NBME Part I + USMLE Step 2; or</text> </paragraph> <paragraph num="(xi)"> <text>FLEX Component 2 + NBME Part I + NBME Part II; or</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Achieve a passing score on each part of the applicable qualifying examination of the Liceniate of the Medical Council of Canada.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant who fails any part, step, level, or component of the examinations or combination of examinations listed in §G(1)of this regulation three or more times shall meet one of the requirements listed in §G(3) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>An otherwise qualified applicant who passes the examination after having failed the examination or any part of the examinations listed in §G(1) of this regulation or any part, step, level, or component of any of the examinations listed in §G(1) three or more times may qualify for a license only if the applicant:</text> <paragraph num="(a)"> <text>Has successfully completed 2 or more years of a residency or fellowship accredited by the ACGME or the AOA;</text> </paragraph> <paragraph num="(b)"> <text>Has met the following requirements:</text> <paragraph num="(i)"> <text>The applicant has a minimum of 5 years clinical practice of medicine in the United States or in Canada, with at least 3 of the 5 years having occurred within 5 years of the date of the application, that occurred under a full unrestricted license to practice medicine; and</text> </paragraph> <paragraph num="(ii)"> <text>The applicant has no disciplinary action pending and has had no disciplinary action taken against the applicant that would be grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is Board-certified.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Notwithstanding §G(1) of this regulation, the Board shall require an applicant to pass the SPEX examination or the Comprehensive Osteopathic Medical Variable-Purpose Examination—USA (COMVEX—USA) if the applicant:</text> <paragraph num="(a)"> <text>Last passed a medical licensing examination more than 15 years before this application;</text> </paragraph> <paragraph num="(b)"> <text>Has never had specialty board certification or last passed a specialty board certification examination given by a member board of the ABMS or the AOA more than 10 years before this application;</text> </paragraph> <paragraph num="(c)"> <text>Has not had a full, unrestricted medical license in at least one state of the United States or Canada within the 10-year period before this application; and</text> </paragraph> <paragraph num="(d)"> <text>Has not actively practiced clinical medicine in the United States or Canada for at least 7 of the 10 years before this application.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Notwithstanding §G(1) of this regulation, the Board may require an applicant to pass the SPEX examination or the Comprehensive Osteopathic Medical Variable-Purpose Examination — USA (COMVEX — USA) if the applicant meets one or more of the conditions listed in §G(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Additional Requirements.</text> <paragraph num="(1)"> <text>Each applicant shall submit a chronological list of all activities beginning with the date of completion of medical school through the date of application. The activities shall be listed by month and year, account for all periods of time, and include but not be limited to the following:</text> <paragraph num="(a)"> <text>All postgraduate training programs attended, regardless of whether the program was completed or not;</text> </paragraph> <paragraph num="(b)"> <text>Each job held, regardless of whether the job was:</text> <paragraph num="(i)"> <text>Medically related or not; or</text> </paragraph> <paragraph num="(ii)"> <text>Compensated or not;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Any other activity engaged in, including all periods of unemployment;</text> </paragraph> <paragraph num="(d)"> <text>An action, by a state licensing or disciplinary board, or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal;</text> </paragraph> <paragraph num="(e)"> <text>An action taken against the physician's license, by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(f)"> <text>An investigation or charge brought against the physician by a licensing or disciplinary body or comparable body in the armed services;</text> </paragraph> <paragraph num="(g)"> <text>A medical or health professional license for which the physician has applied if the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(h)"> <text>An investigation or charge brought against the physician by a hospital, related institution, or alternative health care system that would be grounds for action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(i)"> <text>Any limitation or loss in privileges by a hospital, related health care facility, or alternative health care system that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(j)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act;</text> </paragraph> <paragraph num="(k)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances;</text> </paragraph> <paragraph num="(l)"> <text>An arrest which would provide a basis for investigation or charge which would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(m)"> <text>A physical or mental condition that currently impairs the physician's ability to practice medicine; and</text> </paragraph> <paragraph num="(n)"> <text>The filing or settling of a medical malpractice action in which the physician is, or has been, named as a defendant within the past 5 years.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant shall submit the following additional information:</text> <paragraph num="(a)"> <text>Copies of the complaints, pleadings, and judgments in all malpractice claims if the applicant has had 3 or more claims in the 5 years before the filing of the application for licensure;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all arrests, disciplinary actions, judgments, and final orders which occurred or were issued within the 7 years before submitting the application for licensure for driving while intoxicated, driving while under the influence of a chemical substance or medication, or any license probation, suspension, or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>All medical licensure, certification, and recertification examination results and the dates when these examinations were taken.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>On forms supplied by the Board, an applicant shall agree to release to the Board relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies.</text> </paragraph> <paragraph num="(4)"> <text>On forms supplied by the Board, an applicant shall allow the Board to release information which is not statutorily protected.</text> </paragraph> <paragraph num="(5)"> <text>During the application process, an applicant for licensure shall have the duty to inform the Board by electronic or first-class mail of any of the circumstances listed in §H(1) and (2) of this regulation within 30 days of the occurrence of or notification about these circumstances.</text> </paragraph> <paragraph num="(6)"> <text>If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, the Board may request additional information regarding the applicant's competency from the chief of staff of a hospital where the applicant has practiced.</text> </paragraph> </paragraph> <paragraph num="I."> <text>English Language Competency. The applicant shall demonstrate oral and written English language competency as described in Regulation .04D of this chapter.</text> </paragraph> <paragraph num="J."> <text>Speech Impairment. An applicant wishing to claim speech impairment shall submit documentation of the impairment to the Board as described in Regulation .04E of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure — Documentation for Initial Licensure."> <paragraph num="A."> <text>The applicant shall submit an application on a form supplied by the Board.</text> </paragraph> <paragraph num="B."> <text>Complete Application.</text> <paragraph num="(1)"> <text>A complete application for initial licensure shall include, but is not limited to, proof of the following through documentation on forms supplied by the Board:</text> <paragraph num="(a)"> <text>Verification of medical education;</text> </paragraph> <paragraph num="(b)"> <text>Written and electronic statements from an authorized official of each of the applicant's accredited training programs which:</text> <paragraph num="(i)"> <text>Summarize the experience and performance of the applicant during training;</text> </paragraph> <paragraph num="(ii)"> <text>Detail all actions taken against the applicant by any training program, hospital, medical board, licensing authority, or court for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Document specifically whether or not the applicant successfully completed the years of training;</text> </paragraph> <paragraph num="(iv)"> <text>Detail any limitations of privileges during the postgraduate training years; and</text> </paragraph> <paragraph num="(v)"> <text>Detail any physical and mental health problems of the applicant that affected the applicant's ability to practice during the years of postgraduate training;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation of successful completion of the examination requirements as described in Regulation .03G of this chapter, including submission of all applicant’s scores sent directly to the Board from the examination authority or authorities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may waive the requirement of §B(1)(b) of this regulation on a case-by-case basis, if the applicant's education or training occurred in countries with which reasonable efforts to obtain the required information have been unsuccessful.</text> </paragraph> <paragraph num="(3)"> <text>If licensure in another state preceded the requirement for ECFMG, the Board may waive the requirement for the ECFMG certificate.</text> </paragraph> <paragraph num="(4)"> <text>A complete application which contains a statement from the applicant listing all:</text> <paragraph num="(a)"> <text>Hospitals, following training, at which the applicant has had privileges during the preceding 5 years; and</text> </paragraph> <paragraph num="(b)"> <text>Disciplinary or adverse actions taken against the applicant by a:</text> <paragraph num="(i)"> <text>Hospital,</text> </paragraph> <paragraph num="(ii)"> <text>Medical board,</text> </paragraph> <paragraph num="(iii)"> <text>Licensing authority,</text> </paragraph> <paragraph num="(iv)"> <text>Court, or</text> </paragraph> <paragraph num="(v)"> <text>Adjudicatory body.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A complete application shall include:</text> <paragraph num="(a)"> <text>All application and licensing fees as required in Regulation .12 of this chapter, payable to the Board at the time the application is submitted to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>The applicant's Social Security number which the Board shall use only for evaluation and identification of applicants and licensees, but may not disclose in any other context.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Additional Requirements. Review of an application for licensure shall include:</text> <paragraph num="(1)"> <text>Verification of licensure from all states where the applicant has ever held a license;</text> </paragraph> <paragraph num="(2)"> <text>Verification of voluntary licensure nonrenewal, or voluntary surrender of license while the applicant was in good standing and not under disciplinary charges or investigation at the time the license was surrendered from states where the applicant no longer holds a license;</text> </paragraph> <paragraph num="(3)"> <text>Information in the data bank of the Federation pertaining to the qualifications of the applicant;</text> </paragraph> <paragraph num="(4)"> <text>Information in the National Practitioner Data Bank including but not limited to the following:</text> <paragraph num="(a)"> <text>Medical malpractice judgments against the applicant;</text> </paragraph> <paragraph num="(b)"> <text>Settlements made by the applicant in medical malpractice actions;</text> </paragraph> <paragraph num="(c)"> <text>Actions taken against the applicant or the applicant's license by state disciplinary or licensing authorities; and</text> </paragraph> <paragraph num="(d)"> <text>Actions taken against the applicant or the applicant's privileges by a hospital or hospital disciplinary authority which result in a loss, limitation, or suspension of privileges for a period greater than 30 days; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, original letters of reference from all of the hospitals at which the applicant has had privileges, describing the kind of experience received, the performance of the applicant, and explaining under what circumstances those privileges were limited, revoked, or allowed to lapse.</text> </paragraph> </paragraph> <paragraph num="D."> <text>English Language Competency. The applicant shall demonstrate oral and written competency in English by any of the following:</text> <paragraph num="(1)"> <text>Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of graduation from a recognized English-speaking professional school;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of a passing score on the USMLE step 2 Clinical Skills; or</text> </paragraph> <paragraph num="(4)"> <text>Documentation of receiving:</text> <paragraph num="(a)"> <text>A score of at least 26 on the “Speaking Section” of the Internet-Based TOEFL; or</text> </paragraph> <paragraph num="(b)"> <text>A score of Advanced or higher on the OPI.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Claims of Speech Impairment.</text> <paragraph num="(1)"> <text>Applicants wishing to claim a speech impairment after failing either the TOEFL or the OPI shall submit documentation of this impairment on forms supplied by the Board.</text> </paragraph> <paragraph num="(2)"> <text>Documentation of a speech impairment shall be submitted from a:</text> <paragraph num="(a)"> <text>Licensed physician; and</text> </paragraph> <paragraph num="(b)"> <text>Speech-language pathologist who is currently licensed to practice speech pathology in the United States.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation should be submitted with the applicant’s initial application but, in all cases, shall be submitted before the applicant’s second attempt at passing the TOEFL or the OPI.</text> </paragraph> <paragraph num="(4)"> <text>After the second examination, documentation of an impairment may not be submitted or accepted unless there has been an intervening medical/surgical event which has created the impairment.</text> </paragraph> <paragraph num="(5)"> <text>The applicant shall be allowed to claim the impairment only if:</text> <paragraph num="(a)"> <text>This event was reported to the Board before a third examination; and</text> </paragraph> <paragraph num="(b)"> <text>The Board determines that the medical/surgical event did indeed create the impairment.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the applicant has properly claimed and documented a speech impairment, the Board shall accept the documentation if the applicant is able to prove the ability to communicate with allied health personnel and patients. Proof shall include:</text> <paragraph num="(a)"> <text>Documentation from 3 licensed physicians that the applicant can communicate in a professionally competent manner with patients and health care providers; or</text> </paragraph> <paragraph num="(b)"> <text>A hearing before the Board where the applicant is asked to describe the manner in which the applicant would obtain a history and physical examination from a typical patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The certifying or verifying authority shall send all certificates and verifications directly to the Board for applicants. The Board may not accept certificates and verifications sent to, or by, the applicant.</text> </paragraph> <paragraph num="G."> <text>If any of the documents required under this chapter are in a language other than English, the applicant shall submit the certified translation and bear the expense of translation by a certified translator.</text> </paragraph> <paragraph num="H."> <text>The Board has designated a 4-month period for acting upon applications as follows:</text> <paragraph num="(1)"> <text>Within 60 days after receipt of an application, the Board or its Executive Director will determine whether an application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board or the Executive Director determines that the application is not complete, the Executive Director or the Executive Director's designee shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice, the applicant shall correct the deficiency within 60 days or other period specified in the notice;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to submit a new application and pay the required fees.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Withdrawal of Application.</text> <paragraph num="(1)"> <text>An applicant may not withdraw an application for initial licensure, renewal of a license, or reinstatement of a license without permission of the Board, if:</text> <paragraph num="(a)"> <text>The applicant is currently charged in another jurisdiction with conduct which would be grounds for discipline under the Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State;</text> </paragraph> <paragraph num="(b)"> <text>The applicant is under investigation in another jurisdiction for an allegation concerning conduct that would be grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State; or</text> </paragraph> <paragraph num="(c)"> <text>The Board is investigating the applicant or application or has issued a notice of intent to deny licensure.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In determining whether to allow the withdrawal of a licensure application, the Board may consider such factors as the following:</text> <paragraph num="(a)"> <text>Issues of competence or conduct which caused the matter to be investigated;</text> </paragraph> <paragraph num="(b)"> <text>Duty to protect the public in other jurisdictions from duplicative expenditures on investigation of licensure applications; and</text> </paragraph> <paragraph num="(c)"> <text>Truthfulness of the applicant during the application process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>The Board may accept documentation from the FCVS as evidence of having met some of the requirements of Regulations .03 and .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inactive and Emeritus Licensure."> <paragraph num="A."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>A licensee in good standing who will not practice medicine in this State may apply for inactive status.</text> </paragraph> <paragraph num="(2)"> <text>A licensee applying for an inactive license shall pay the inactive license fee and any additional charges set by the Board.</text> </paragraph> <paragraph num="(3)"> <text>A licensee may apply for inactive status if the licensee has an unrestricted active license to practice medicine in this State or is within 60 days of the expiration of the licensee’s unrestricted active license.</text> </paragraph> <paragraph num="(4)"> <text>Renewal.</text> <paragraph num="(a)"> <text>An inactive status shall be renewed every 2 years.</text> </paragraph> <paragraph num="(b)"> <text>At the end of 2 years, a licensee with inactive status shall complete the renewal application, and pay the renewal fee, and any charges set by the Board.</text> </paragraph> <paragraph num="(c)"> <text>If the licensee fails to renew their inactive license for any reason, the license will expire.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A licensee with an inactive license may not:</text> <paragraph num="(a)"> <text>Practice medicine within Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Prescribe medication within Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Conduct peer reviews of physicians within Maryland.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A licensee on inactive status shall have the duty to inform the Board by [electronic] email or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances.</text> </paragraph> <paragraph num="(7)"> <text>The inactive status of a licensee does not deprive the Board of its authority to institute or continue a disciplinary proceeding against a licensee.</text> </paragraph> <paragraph num="(8)"> <text>To reinstate a license to active status, a licensee on inactive status shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician may not practice medicine until the license is reinstated to active status.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Emeritus Status.</text> <paragraph num="(1)"> <text>A licensee who meets the requirements under §B(3) of this regulation, who will not practice medicine in this State, and who is retired from practicing medicine in this State may apply for emeritus status.</text> </paragraph> <paragraph num="(2)"> <text>A licensee applying for emeritus status shall complete the emeritus application and pay the application fee as set by the Board.</text> </paragraph> <paragraph num="(3)"> <text>A licensee may apply for emeritus status if the licensee:</text> <paragraph num="(a)"> <text>Has practiced medicine in Maryland for at least 10 years;</text> </paragraph> <paragraph num="(b)"> <text>Has an active, unrestricted license to practice medicine in Maryland or is within 60 days of the expiration of an active, unrestricted license;</text> </paragraph> <paragraph num="(c)"> <text>Has never been the subject of disciplinary action that has resulted in revocation or suspension of a medical license in any jurisdiction in which they have been licensed to practice medicine;</text> </paragraph> <paragraph num="(d)"> <text>Is not under investigation by the Board; and</text> </paragraph> <paragraph num="(e)"> <text>Is in good standing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensee with emeritus status may not:</text> <paragraph num="(a)"> <text>Practice, offer to practice, or attempt to practice medicine within Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Delegate medical acts within Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Prescribe medication within Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>Conduct peer review of physicians within Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A licensee with emeritus status shall complete the renewal application and pay the emeritus renewal fee and any charges set by the Board every third renewal cycle.</text> </paragraph> <paragraph num="(6)"> <text>A licensee on emeritus status shall have the duty to inform the Board by email or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter, including a change of address, within 30 days of the occurrence of or notification about these circumstances.</text> </paragraph> <paragraph num="(7)"> <text>The emeritus status of a licensee does not deprive the Board of authority to institute or continue a disciplinary proceeding against a licensee.</text> </paragraph> <paragraph num="(8)"> <text>To reinstate a license to active status, a physician whose license is on emeritus status shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician may not practice medicine until the license is reinstated to active status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Qualifications for Limited License for Postgraduate Teaching."> <paragraph num="A."> <text>Moral Character. The applicant for a limited license for postgraduate teaching shall be of good moral character.</text> </paragraph> <paragraph num="B."> <text>Age. The applicant for a limited license for postgraduate teaching shall be 18 years old or older.</text> </paragraph> <paragraph num="C."> <text>Education, Training, and Experience.</text> <paragraph num="(1)"> <text>To meet the education and training requirements, a qualified applicant for a limited license for postgraduate teaching shall have:</text> <paragraph num="(a)"> <text>Graduated from an LCME-accredited medical school or a foreign medical school that is listed in the World Directory of Medical Schools at the time of the applicant's graduation or, for doctors of osteopathy, meet the requirements of Health Occupations Article, §14-307(d)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactorily completed a postgraduate training program which meets the following requirements:</text> <paragraph num="(i)"> <text>The postgraduate training shall have been in the specialty in which the applicant will function as a postgraduate teacher,</text> </paragraph> <paragraph num="(ii)"> <text>The postgraduate training shall have included at least the same number of years of specialty postgraduate training as would be required for certification by that specialty's board in the United States and submit the requirements of both to the Board, and</text> </paragraph> <paragraph num="(iii)"> <text>The applicant shall submit documents both from the United States and, if the applicant's specialty postgraduate training was obtained outside the United States, from each foreign specialty board to the Board; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Passed that specialty's certifying examination in either the country where specialty postgraduate training was obtained or where the applicant is practicing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A qualified postgraduate applicant shall meet the following experience requirements:</text> <paragraph num="(a)"> <text>Be a member in good standing of the specialty board in the country from which the applicant is applying; and</text> </paragraph> <paragraph num="(b)"> <text>Have functioned independently as both an academician and clinician for at least 3 years after the completion of postgraduate specialty training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Fees. An applicant for a limited license for postgraduate teaching shall pay the limited license fee for postgraduate teaching and any additional charges set by the Board.</text> </paragraph> <paragraph num="E."> <text>Additional Requirements for Postgraduate Teaching Licenses.</text> <paragraph num="(1)"> <text>The Board may require additional information which includes, but is not limited to, the following:</text> <paragraph num="(a)"> <text>Letter from the chief of staff of any hospital where the applicant has practiced within the 5 years preceding the application for a postgraduate teaching license, detailing the applicant's competence to practice medicine;</text> </paragraph> <paragraph num="(b)"> <text>Malpractice history;</text> </paragraph> <paragraph num="(c)"> <text>Driving record including, but not limited to, convictions for driving while intoxicated or while under the influence of a chemical substance or medication;</text> </paragraph> <paragraph num="(d)"> <text>Medical licensing examination results;</text> </paragraph> <paragraph num="(e)"> <text>Physical or mental examinations, or both, by a physician or evaluation program for treatment of impaired physicians, or both, chosen by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On forms supplied by the Board, an applicant shall agree to release to the Board information from other institutions and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies.</text> </paragraph> <paragraph num="(3)"> <text>During the application process, an applicant for a limited license for postgraduate teaching shall have the duty to inform the Board by electronic or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances.</text> </paragraph> <paragraph num="(4)"> <text>A teaching institution seeking to obtain limited licenses for their postgraduate teachers shall present the Board with the following information:</text> <paragraph num="(a)"> <text>Detailed evidence of the physician's qualifications and competence including the nature of the physician's proposed responsibilities, reasons for any limitations of those practice responsibilities, and the degree of supervision under which the physician will function, if any;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the relevant sections of the hospital bylaws which detail the requirements for, and mechanism of, supervising physicians; and</text> </paragraph> <paragraph num="(c)"> <text>A copy of the relevant section of the hospital bylaws which detail the requirements for, and mechanism of, supervision of postgraduate physician teachers.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An applicant for a postgraduate teaching license shall agree that the applicant will:</text> <paragraph num="(a)"> <text>Only practice within the teaching institutions and programs specified within the application;</text> </paragraph> <paragraph num="(b)"> <text>Practice medicine only in conjunction with the applicant's teaching responsibilities; and</text> </paragraph> <paragraph num="(c)"> <text>Not practice medicine outside the applicant's teaching responsibilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>English Language Competency. The applicant shall demonstrate oral and written English language competency as described in Regulation .04D of this chapter.</text> </paragraph> <paragraph num="G."> <text>Speech Impairment. Applicants wishing to claim speech impairments shall submit documentation of these impairments to the Board as described in Regulation .04E of this chapter.</text> </paragraph> <paragraph num="H."> <text>Terms and Renewal of Postgraduate Teaching Licenses.</text> <paragraph num="(1)"> <text>The Board shall issue a postgraduate teaching license with a term of 1 year.</text> </paragraph> <paragraph num="(2)"> <text>The Board may renew a limited license for postgraduate teaching only once for a maximum period of 1 year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Setting of Fees."> <text>All fees, not set by statute, will be set by the Board. A copy of the current fee schedule is set forth in Regulation .12 of this chapter. Fees paid to the Board are nonrefundable.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Renewals."> <paragraph num="A."> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="B."> <text>A licensee shall renew the license every 2 years.</text> </paragraph> <paragraph num="C."> <text>At least 1 month before the license expires, the Board shall send to the last known address of record of the licensee, by electronic or first-class mail:</text> <paragraph num="(1)"> <text>A renewal notice that states:</text> <paragraph num="(a)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(b)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the license expires;</text> </paragraph> <paragraph num="(c)"> <text>The amount of the renewal fee and any additional charges set by the Board; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A blank panel data sheet supplied by the Health Care Alternative Dispute Resolution Office.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board chooses to send renewal notices exclusively by electronic mail, the Board shall send a renewal notice by first-class mail to a licensee on request of the licensee.</text> </paragraph> <paragraph num="E."> <text>The failure to receive a renewal notice does not excuse a licensee from complying with §B of this regulation.</text> </paragraph> <paragraph num="F."> <text>Before the expiration date of the license, a licensee applying for renewal shall complete the application for renewal on a form supplied by the Board.</text> </paragraph> <paragraph num="G."> <text>A licensee shall inform the Board by electronic or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances.</text> </paragraph> <paragraph num="H."> <text>A licensee applying for renewal shall complete the CME requirements as defined in Regulation .10 of this chapter.</text> </paragraph> <paragraph num="I."> <text>A licensee applying for renewal shall pay the renewal fee and any additional charges set by the Board.</text> </paragraph> <paragraph num="J."> <text>After the expiration date of the license, the physician is no longer licensed to practice medicine.</text> </paragraph> <paragraph num="K."> <text>The Board may impose a fine of up to $50,000 for practicing without a license if a formerly licensed physician:</text> <paragraph num="(1)"> <text>Fails to submit an application and to pay the requisite renewal fee within 60 days of the expiration of the license; or</text> </paragraph> <paragraph num="(2)"> <text>Practices medicine 60 days after the expiration of the license or thereafter.</text> </paragraph> </paragraph> <paragraph num="L."> <text>A holder of a restricted license to practice osteopathy shall renew the license every year as follows:</text> <paragraph num="(1)"> <text>Submit a renewal form supplied by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pay a renewal fee and any additional charges set by the Board.</text> </paragraph> </paragraph> <paragraph num="M."> <text>A licensee applying for the first renewal shall have completed an orientation program approved by the Board. The Board may defer this requirement for physicians practicing out of State or in cases of individual hardship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Expired Licensure."> <paragraph num="A."> <text>A licensee with an expired license may not:</text> <paragraph num="(1)"> <text>Practice medicine within Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Prescribe medicine within Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>Conduct peer review of physicians within Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician whose license is expired and who wishes to practice medicine in Maryland shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician is not licensed to practice medicine until the license is reinstated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Continuing Medical Education."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“2-year period” means:</text> <paragraph num="(i)"> <text>For license renewal, the 2 years preceding the expiration of the physician license; or</text> </paragraph> <paragraph num="(ii)"> <text>For license reinstatement, the 2 years preceding the date of the submission of the application for reinstatement of the physician license.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Applicant” means:</text> <paragraph num="(i)"> <text>A licensed physician applying for renewal of the physician license; or</text> </paragraph> <paragraph num="(ii)"> <text>A physician applying for reinstatement of the physician license.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board recognizes and accepts CME activities which serve to maintain, develop, or increase knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession, and are within the basic medical sciences, the disciplines of clinical medicine, and the provision of health care to the public.</text> </paragraph> <paragraph num="C."> <text>Requirements.</text> <paragraph num="(1)"> <text>In accordance with the requirements specified in §C(2) of this regulation, in a 2-year period, an applicant shall earn at least 50 credit hours of Category I or II CME, with at least 25 of those CME credit hours being Category 1.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall recognize for Category I or II CME credit those activities which meet at least one of the following additional requirements for the activity:</text> <paragraph num="(a)"> <text>Be accredited as Category I or II by the ACCME;</text> </paragraph> <paragraph num="(b)"> <text>Be sponsored by an international, national, or state medical society, and meet the standards adopted by the ACCME;</text> </paragraph> <paragraph num="(c)"> <text>Be an accredited training program and have been attended by the applicant within a 2-year period, on the basis of either of the following:</text> <paragraph num="(i)"> <text>1 year of full-time service earns 50 CME credit hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Full-time service for a portion of a year earns 1 credit hour per week; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Is a service performed by a Board designee and involves medical record review for the Board and the service is performed without compensation and is credited up to a maximum of 10 credit hours for a 2-year period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>On the application form for renewal or reinstatement, the applicant shall attest to the fact that the applicant has completed the CME requirement.</text> </paragraph> <paragraph num="E."> <text>Documentation of CME Credits.</text> <paragraph num="(1)"> <text>The applicant has the affirmative obligation to obtain the requisite documentation of CME attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall be considered to have met the requirements of §C(1) of this regulation if the applicant:</text> <paragraph num="(a)"> <text>Currently holds an active time-limited certification issued by:</text> <paragraph num="(i)"> <text>A member of the American Board of Medical Specialties;</text> </paragraph> <paragraph num="(ii)"> <text>An American Osteopathic Association Certifying Board;</text> </paragraph> <paragraph num="(iii)"> <text>The Royal College of Physicians and Surgeons of Canada; or</text> </paragraph> <paragraph num="(iv)"> <text>The College of Family Physicians of Canada; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provides proof of maintenance of a time-limited Board certification that is dated no longer than 5 years prior to the renewal date.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The required documentation of attendance at a CME program as described in §C(2)(a) and (b) of this regulation shall be a certificate or other documentation of attendance which shall:</text> <paragraph num="(a)"> <text>Contain at a minimum the:</text> <paragraph num="(i)"> <text>Program title;</text> </paragraph> <paragraph num="(ii)"> <text>Sponsor's name;</text> </paragraph> <paragraph num="(iii)"> <text>Physician's name;</text> </paragraph> <paragraph num="(iv)"> <text>Inclusive date or dates and location of the CME event;</text> </paragraph> <paragraph num="(v)"> <text>CME category designation and the number of designated or prescribed CME credit hours; and</text> </paragraph> <paragraph num="(vi)"> <text>Documented verification of successful completion by stamp, signature, hospital printout, or other official proof; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Demonstrate that the CME activity fell within a 2-year period.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The required documentation of attendance at an accredited residency or fellowship as described in §C(2)(c) of this regulation shall be a certificate or other form of documentation which shall contain at the minimum the:</text> <paragraph num="(a)"> <text>Program title;</text> </paragraph> <paragraph num="(b)"> <text>ACGME accredited sponsor's name and location;</text> </paragraph> <paragraph num="(c)"> <text>Physician's name;</text> </paragraph> <paragraph num="(d)"> <text>Inclusive dates of the residency or fellowship;</text> </paragraph> <paragraph num="(e)"> <text>Specialty area of residency or fellowship; and</text> </paragraph> <paragraph num="(f)"> <text>Documented verification of completion by the sponsor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Board shall apply the CME requirement to all renewal and reinstatement applications after the first renewal, or, in the case of an applicant who has never renewed, after initial licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Reinstatement Expired, Emeritus, or Inactive Licenses."> <paragraph num="A."> <text>A physician who has failed to renew a license by the license expiration date and whose license has been placed on inactive status or whose license has been placed on emeritus status shall apply for reinstatement on a form supplied by the Board in order to resume the practice of medicine in this State.</text> </paragraph> <paragraph num="B."> <text>A physician applying for reinstatement shall pay a reinstatement fee and any additional charges set by the Board.</text> </paragraph> <paragraph num="C."> <text>A physician applying for reinstatement shall submit documentation of completing the required number of CME hours for reinstatement as defined in Regulation .10 of this chapter.</text> </paragraph> <paragraph num="D."> <text>A physician applying for reinstatement may be denied reinstatement subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, for any of the grounds listed in Health Occupations Article, §14-404, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>A physician applying for reinstatement shall provide the Board with a detailed description of activities which have occurred since the last renewal application or, in the case of a physician who has never renewed, since the date when a medical licensure application was submitted to the Board. This description may include, but not necessarily be limited to, the information required under Regulations .03 and .04 of this chapter.</text> </paragraph> <paragraph num="F."> <text>A physician applying for reinstatement may be required to pass the SPEX or COMVEX-USA examination if the physician:</text> <paragraph num="(1)"> <text>Last passed a medical licensing examination more than 15 years before this application;</text> </paragraph> <paragraph num="(2)"> <text>Has never had specialty board certification or last passed a specialty board certification examination given by a member board of the ABMS or the AOA Bureau of Osteopathic Specialists more than 10 years before this application;</text> </paragraph> <paragraph num="(3)"> <text>Has not had a full, unrestricted medical license in at least one state of the United States or Canada within the 10-year period before this application; or</text> </paragraph> <paragraph num="(4)"> <text>Has not actively practiced clinical medicine in the United States or Canada for at least 7 of the 10 years before this application.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The physician shall include a statement on the application form for reinstatement agreeing to the above examination requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Fees."> <text>The fees are as follows:</text> <paragraph num="A."> <text>Application fees.</text> <paragraph num="(1)"> <text>Original physician or osteopath licensure application, American and foreign school graduate ... $310;</text> </paragraph> <paragraph num="(2)"> <text>Conceded eminence application ... $1,090;</text> </paragraph> <paragraph num="(3)"> <text>Physician license fee per month until expiration of initial license ... $20;</text> </paragraph> <paragraph num="(4)"> <text>Physician inactive license ... $218;</text> </paragraph> <paragraph num="(5)"> <text>Postgraduate teaching license ... $300;</text> </paragraph> <paragraph num="(6)"> <text>Physician emeritus license ... $120;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal fees:</text> <paragraph num="(1)"> <text>Physician biennial license renewal ... $486;</text> </paragraph> <paragraph num="(2)"> <text>Inactive biennial renewal fee ... $218;</text> </paragraph> <paragraph num="(3)"> <text>Physician emeritus renewal fee ... $120;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physician reinstatement fee ... $700;</text> </paragraph> <paragraph num="D."> <text>Other fees:</text> <paragraph num="(1)"> <text>Replacement of license for a name change ... $25;</text> </paragraph> <paragraph num="(2)"> <text>Permit to dispense prescription drugs ... $1,050;</text> </paragraph> <paragraph num="(3)"> <text>Written verification of licensure ... $50;</text> </paragraph> <paragraph num="(4)"> <text>Electronic records ... $45 plus $0.05 per record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Advertising."> <paragraph num="A."> <text>A physician may place advertisements.</text> </paragraph> <paragraph num="B."> <text>An advertisement may not contain:</text> <paragraph num="(1)"> <text>Statements containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Statements that cannot be verified by the Board for truthfulness;</text> </paragraph> <paragraph num="(3)"> <text>Statements likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(4)"> <text>Statements intended to, or likely to, create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(5)"> <text>Statements specifying a fee for professional service which does not include the cost of all related procedures, services, and products which to a substantial likelihood will be necessary for the completion of the advertised service as it would be understood by an ordinarily prudent person;</text> </paragraph> <paragraph num="(6)"> <text>Statements advertising discounted or free services, examinations, or treatments when there will be an additional charge for any additional services, examinations, or treatments which are performed as a result of and within 72 hours of the initial office visit in response to the advertisement unless the professional services rendered are a result of a bona fide emergency;</text> </paragraph> <paragraph num="(7)"> <text>Statements conveying the impression that the physician could improperly influence any public body, official, corporation, or any person on behalf of a patient;</text> </paragraph> <paragraph num="(8)"> <text>Statements containing representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or be deceived; or</text> </paragraph> <paragraph num="(9)"> <text>Statements containing representations that the physician is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A physician who is not board certified as defined in Regulation .02B(9) of this chapter may not use the term “board certified” to describe the physician’s qualifications or make any representation that the physician has received formal recognition as a specialist in any aspect of the practice of medicine.</text> </paragraph> <paragraph num="D."> <text>A physician who is board certified may not use the term “board certified” to indicate certification or expertise in a specialty or subspecialty area other than that in which the physician is certified by the certifying board.</text> </paragraph> <paragraph num="E."> <text>An advertisement may represent that a physician subspecializes in an area of medicine if the physician first identifies the physician's specialty.</text> </paragraph> <paragraph num="F."> <text>This regulation does not prevent a physician from accurately describing a focus of the physician's practice in a field within the scope of the physician's training and board certification.</text> </paragraph> <paragraph num="G."> <text>A physician shall also be accountable under this regulation if he uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> <paragraph num="H."> <text>An advertisement may state a range of prices for specifically described services if reasonable disclosure of all relevant variables and consideration is made.</text> </paragraph> <paragraph num="I."> <text>The Board shall keep a record of those physicians who have been:</text> <paragraph num="(1)"> <text>Identified by the Board of Physician Quality Assurance as specialists before October 1, 1996; or</text> </paragraph> <paragraph num="(2)"> <text>Certified by the American Board of Medical Specialties and the American Osteopathic Association.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Solicitation."> <paragraph num="A."> <text>A physician may not engage in solicitation, including in-person, telephone, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation, or overreaching;</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .13B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician shall also be accountable under this regulation if he uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Name under which Licensee May Practice."> <paragraph num="A."> <text>A physician shall be licensed to practice only under the name on the license.</text> </paragraph> <paragraph num="B."> <text>A licensee wishing to change the name under which the licensee practices shall obtain the Board's approval under Regulation .15B and C of this chapter.</text> </paragraph> <paragraph num="C."> <text>The failure of a licensee to practice under the name on the license shall be considered unprofessional conduct by the Board and grounds for disciplinary action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Replacement Licenses."> <paragraph num="A."> <text>The Board shall issue a replacement license or registration card if the original license is lost, destroyed, stolen, or damaged, or if there has been a change of the licensee's name.</text> </paragraph> <paragraph num="B."> <text>The Board shall require that the following accompany requests for replacement licenses:</text> <paragraph num="(1)"> <text>The proper fee;</text> </paragraph> <paragraph num="(2)"> <text>Any required application forms which are to include the reason for the replacement license request;</text> </paragraph> <paragraph num="(3)"> <text>A passport quality photograph of the licensee, taken within 60 days of the application, affixed to the affidavit form supplied by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Return of the original license if the license is damaged or a replacement is sought for reasons of a name change.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the request for a replacement license results from a change of name, the licensee shall submit a certified copy of the official document (marriage certificate, divorce decree, court order, or other document) indicating the name change, date, and place of change. If the change occurred during naturalization, the applicant shall also include the naturalization number, name and address of the court, and the date of naturalization, as well as the name change.</text> </paragraph> <paragraph num="D."> <text>The Board shall issue a replacement license which bears the same number and expiration date as the original and shall print “Replacement” and the date of replacement across the front of the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Initial Licensure by Reciprocity."> <paragraph num="A."> <text>Requirements. An applicant for initial licensure by reciprocity shall:</text> <paragraph num="(1)"> <text>Have an active, unrestricted license to practice medicine in another jurisdiction that:</text> <paragraph num="(a)"> <text>At the time the applicant was licensed, had licensure requirements substantially equivalent to the Board’s current licensure requirements as set forth in Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Offers a similar reciprocal licensure process to physicians licensed by the Board;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be in good standing under the laws of every jurisdiction where the individual is licensed; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Documentation. An applicant for initial licensure by reciprocity shall submit:</text> <paragraph num="(1)"> <text>An application for reciprocity on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The application fee as set by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Evidence of compliance with §A of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Any additional documentation set forth in Regulation .04 of this chapter that is needed for the Board to evaluate an application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>On receipt of the documentation required in §B of this regulation, the Board shall process the application for initial license by reciprocity in an expedited manner.</text> </paragraph> <paragraph num="D."> <text>The Board may not issue a license if the criminal history records information, pursuant to §A of this regulation, has not been received.</text> </paragraph> <paragraph num="E."> <text>After a license is issued, the licensee is subject to the Board’s jurisdiction and shall comply with all laws and regulations governing the practice of medicine in the State.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 14-101, 14-205—14-207, 14-301, 14-302, 14-304—14-307, 14-310, 14-311, 14-313, 14-314, 14-316—14-318, 14-320, 14-320.1, 14-503, 14-505, and 14-606, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 7, 1971</annotation> <annotation type="History" subtype="Administrative History">Amended effective November 9, 1971; March 31, 1976 (3:7 Md. R. 401)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 16, 1977 (4:6 Md. R. 507)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 25, 1980 (7:15 Md. R. 1425)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective February 20, 1981 (8:4 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective May 5, 1978 (5:9 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D adopted effective February 20, 1981 (8:4 Md. R. 342)</annotation> <annotation type="History" subtype="Administrative History">Regulations .09 and .10 adopted effective July 25, 1980 (7:15 Md. R. 1425)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 20, 1982 (9:25 Md. R. 2484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A adopted as an emergency provision effective June 1, 1983 (10:12 Md. R. 1070); emergency status extended at 10:15 Md. R. 1342 and 10:23 Md. R. 2060</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 30, 1984 (11:2 Md. R. 113)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted as an emergency provision effective July 1, 1991 (18:14 Md. R. 1607); emergency status expired January 1, 1992 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective January 2, 1992 (18:25 Md. R. 2751)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 1, 1994 (21:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543); October 2, 2000 (27:19 Md. R. 1725); June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 2, 2000 (27:19 Md. R. 1725); June 25, 2001 (28:12 Md. R. 1110); July 22, 2002 (29:14 Md. R. 1075)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended as an emergency provision effective October 28, 2002 (29:23 Md. R. 1807); amended permanently effective February 17, 2003 (30:3 Md. R. 180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective December 9, 2004 (31:24 Md. R. 1726); November 7, 2005 (32:22 Md. R. 1756); February 22, 2010 (37:4 Md. R. 341)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B—E amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, E, H amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E, G—I amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08K adopted effective April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, D amended effective October 7, 1996 (23:20 Md. R. 1423); October 20, 1997 (24:21 Md. R. 1450); April 17, 2000 (27:7 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended and J adopted effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 5, 1999 (26:7 Md. R. 543); March 20, 2000 (27:5 Md. R. 705); April 2, 2001 (28:6 Md. R. 621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective December 29, 1997 (24:26 Md. R. 1759); April 17, 2000 (27:7 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A, D amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective July 22, 2002 (29:14 Md. R. 1075)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16B amended effective October 7, 1996 (23:20 Md. R. 1423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 repealed effective July 22, 2002 (29:14 Md. R. 1075)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 29, 2014 (41:19 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 26, 2019 (46:17 Md. R. 727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective August 7, 2023 (50:15 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective August 26, 2019 (46:17 Md. R. 727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective January 2, 2017 (43:26 Md. R. 1446); September 30, 2024 (51:19 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11I repealed effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11I, J adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 298); emergency status expired effective July 3, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective April 23, 2018 (45:8 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12E amended effective July 20, 2015 (42:14 Md. R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective June 19, 2017 (44:12 Md. R. 588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17F adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 298); emergency status expired effective July 3, 2022</annotation> </annotations> </chapter> <chapter num="02" heading="Hearings Before the Board of Physicians"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern procedures for disciplinary and licensing matters before the Board of Physicians.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative action” means an order issued by the Board for reasons other than the disciplinary grounds under Health Occupations Article, §14-404, Annotated Code of Maryland, and that is not considered a disciplinary action.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative expungement” means the classification of a record by the Board as confidential, not for public release, and removed from the licensee’s public individual profile.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative law judge (ALJ)” means a hearing officer delegated the duty of conducting evidentiary hearings for the Board or disciplinary panel.</text> </paragraph> <paragraph num="(4)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Administrative prosecutor” means the attorney assigned from the Office of the Attorney General to prosecute administrative charges.</text> </paragraph> <paragraph num="(6)"> <text>Administrative Reinstatement.</text> <paragraph num="(a)"> <text>“Administrative reinstatement” means the reactivation of an inactive or expired license.</text> </paragraph> <paragraph num="(b)"> <text>“Administrative reinstatement” does not include postdisciplinary reinstatement.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Advisory letter” means a nonpublic letter issued by a disciplinary panel which informs, educates, or admonishes an individual licensed by the Board in regard to the practice of medicine or an allied health profession.</text> </paragraph> <paragraph num="(8)"> <text>“Allied health professional” means an individual who is licensed by the Board under:</text> <paragraph num="(a)"> <text>Health Occupations Article, §§14-5A—14-5F, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 15, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Applicant” means an individual who has submitted an application to:</text> <paragraph num="(a)"> <text>The Board for initial licensure, for administrative expungement, or for administrative reinstatement; or</text> </paragraph> <paragraph num="(b)"> <text>Disciplinary panel for postdisciplinary reinstatement.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Board” means the Maryland State Board of Physicians.</text> </paragraph> <paragraph num="(11)"> <text>“Board counsel” means the attorney assigned from the Office of the Attorney General for the purpose of advice on legal matters before the Board or a disciplinary panel.</text> </paragraph> <paragraph num="(12)"> <text>“Cease and desist order” means an order of the Board issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland, prohibiting an individual from practicing medicine without a license or from taking an action for which there are grounds for discipline under Health Occupations Article, §14-404, and which poses a serious risk to the health, safety, and welfare of a patient.</text> </paragraph> <paragraph num="(13)"> <text>“Charging document” means written notification that sets forth the grounds upon which the Board or a disciplinary panel is taking administrative action against the respondent or applicant.</text> </paragraph> <paragraph num="(14)"> <text>Complaint.</text> <paragraph num="(a)"> <text>“Complaint” means an allegation or report that:</text> <paragraph num="(i)"> <text>A Board licensee has committed a prohibited act for which a disciplinary panel can take disciplinary action or impose a fine;</text> </paragraph> <paragraph num="(ii)"> <text>An individual is practicing medicine without a license; or</text> </paragraph> <paragraph num="(iii)"> <text>A licensed physician has acted necessitating a Board action under Health Occupations Article, §14-206(e)(2), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Complaint” includes, but is not limited to, the following:</text> <paragraph num="(i)"> <text>Issuance of a certificate of merit in a malpractice claim;</text> </paragraph> <paragraph num="(ii)"> <text>A report from a hospital or related institution, or an alternative health system, pursuant to Health Occupations Article, §14-413 or 14-414, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A law enforcement report;</text> </paragraph> <paragraph num="(iv)"> <text>A report from another country, state, or jurisdiction or the armed services of the United States;</text> </paragraph> <paragraph num="(v)"> <text>A malpractice insurance report;</text> </paragraph> <paragraph num="(vi)"> <text>A report from another federal or state agency or court in any country, state, or jurisdiction;</text> </paragraph> <paragraph num="(vii)"> <text>Consumer complaints;</text> </paragraph> <paragraph num="(viii)"> <text>Media publications;</text> </paragraph> <paragraph num="(ix)"> <text>Statements on applications for licensure, renewal, or reinstatement; and</text> </paragraph> <paragraph num="(x)"> <text>Other information, from whatever source, which warrants investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Contested case” has the meaning stated in State Government Article, §10-202(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which:</text> <paragraph num="(a)"> <text>Is composed of 11 Board members; and</text> </paragraph> <paragraph num="(b)"> <text>Addresses:</text> <paragraph num="(i)"> <text>Complaints and disciplinary actions against licensed physicians and allied health professionals; and</text> </paragraph> <paragraph num="(ii)"> <text>Postdisciplinary licensure reinstatements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Disposition agreement” means a formal nonpublic agreement by which the health care provider agrees to comply with certain conditions and the disciplinary panel stays further investigation or forgoes further action on a matter based on compliance with those conditions.</text> </paragraph> <paragraph num="(18)"> <text>“Final order” means:</text> <paragraph num="(a)"> <text>The final written decision of the Board or disciplinary panel which results from a contested case proceeding or other formal proceeding and which contains findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(i)"> <text>Denies a license;</text> </paragraph> <paragraph num="(ii)"> <text>Sanctions by reprimand, probation, fine, consent order, suspension, or revocation;</text> </paragraph> <paragraph num="(iii)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(iv)"> <text>Accepts a surrender of a license; or</text> </paragraph> <paragraph num="(v)"> <text>Denies administrative reinstatement of a license;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order that denies postdisciplinary reinstatement of a license; or</text> </paragraph> <paragraph num="(c)"> <text>An order to cease and desist from the practice of medicine.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Fine” means a monetary penalty.</text> </paragraph> <paragraph num="(20)"> <text>“Imperatively requires” means that an action shall be undertaken pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, as a result of factual contentions which raise a substantial likelihood of risk of serious harm to the public health, safety, or welfare before an evidentiary hearing governed by the Administrative Procedure Act is likely to be completed and result in a final order.</text> </paragraph> <paragraph num="(21)"> <text>Investigation.</text> <paragraph num="(a)"> <text>“Investigation” means the gathering of the information necessary for the Board or a disciplinary panel to determine one or more of the following:</text> <paragraph num="(i)"> <text>Whether there is reasonable cause to charge the respondent with a violation of the Medical Practice Act or another statute which gives a disciplinary panel disciplinary authority;</text> </paragraph> <paragraph num="(ii)"> <text>Whether an applicant is eligible for licensure or administrative reinstatement;</text> </paragraph> <paragraph num="(iii)"> <text>The facts necessary for the Board to issue a declaratory ruling; or</text> </paragraph> <paragraph num="(iv)"> <text>Whether an individual has complied with any disciplinary panel order.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Investigation” includes:</text> <paragraph num="(i)"> <text>A preliminary investigation; and</text> </paragraph> <paragraph num="(ii)"> <text>A full investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Involved medical specialty” means the area of medical specialty whose practitioners, in the disciplinary panel’s opinion:</text> <paragraph num="(a)"> <text>Treat the medical or surgical ailment, symptom, or problem in question; and</text> </paragraph> <paragraph num="(b)"> <text>Would likely be familiar with the risks and benefits of treatments provided for that ailment, symptom, or problem.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Licensure” means permission to engage in a health care profession regulated by the Board.</text> </paragraph> <paragraph num="(24)"> <text>“Medical Practice Act” means Health Occupations Article, §§14-101—14-702, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Peer review” means an evaluation by a physician or physicians with special qualifications to judge the matter at hand, based on professional involvement within the involved medical specialty or specialties, of an act or acts of medical or surgical care, or other acts connected with medical practice, by an applicant or licensee.</text> </paragraph> <paragraph num="(26)"> <text>“Post deprivation hearing” means a disciplinary panel hearing scheduled after the disciplinary panel has issued an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, and at which the respondent has the opportunity to explain why the disciplinary panel should rescind the order of summary suspension.</text> </paragraph> <paragraph num="(27)"> <text>“Postdisciplinary reinstatement” means:</text> <paragraph num="(a)"> <text>The reactivation of a revoked or suspended license; or</text> </paragraph> <paragraph num="(b)"> <text>The reactivation of a license surrendered while the licensee was under investigation or subject to disciplinary charges.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Predeprivation hearing” means a disciplinary panel hearing at which the respondent has the opportunity to explain why the disciplinary panel should not issue an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Preliminary investigation” means the initial review of a complaint or application irregularity which is the basis for the decision on whether to assign the case to a disciplinary panel for a full investigation or whether to close the investigation due to lack of jurisdiction or because, even if there were a full investigation, there still would not be a legal or factual basis for the issuance of a charging document.</text> </paragraph> <paragraph num="(30)"> <text>“Prohibited act” means any conduct for which the Board or a disciplinary panel can issue a sanction.</text> </paragraph> <paragraph num="(31)"> <text>“Proposed decision” means the proposed findings of fact and, where required by the delegation order from the Board or a disciplinary panel, the proposed conclusions of law and proposed disposition issued by the administrative law judge.</text> </paragraph> <paragraph num="(32)"> <text>“Public individual profile” means the licensee profile maintained by the Board in accordance with Health Occupations Article, §14-411.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Recusal” means disqualification by a Board or disciplinary panel member from participating in a proceeding because of a legal interest or prejudice in the case before the Board or disciplinary panel.</text> </paragraph> <paragraph num="(34)"> <text>“Respondent” means an individual who has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of a statute over which the Board or a disciplinary panel has jurisdiction;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential summary suspension pursuant to State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Given notice to answer allegations concerning violations of a Board or disciplinary panel order.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Revocation” means the removal of a health care provider’s license to practice a health occupation.</text> </paragraph> <paragraph num="(36)"> <text>“Sanction” means an action by the Board or a disciplinary panel which:</text> <paragraph num="(a)"> <text>Reprimands;</text> </paragraph> <paragraph num="(b)"> <text>Places on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fines;</text> </paragraph> <paragraph num="(d)"> <text>Suspends or revokes a license;</text> </paragraph> <paragraph num="(e)"> <text>Disciplines by a consent order; or</text> </paragraph> <paragraph num="(f)"> <text>Accepts a letter of surrender in lieu of charges or further investigation or prosecution.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Sanctioning guidelines” means guidelines set out in Regulation .10 of this chapter, indicating the minimum and maximum penalty associated with each ground for discipline and mitigating or aggravating circumstances which could result in imposition of a penalty below the minimum or above the maximum.</text> </paragraph> <paragraph num="(38)"> <text>“Show cause” means a demand by letter or order issued by a disciplinary panel, which directs the respondent to:</text> <paragraph num="(a)"> <text>Respond either in writing or by an appearance before the Board or a disciplinary panel; and</text> </paragraph> <paragraph num="(b)"> <text>Present reasons and argument why a particular order should not be entered.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Special qualifications to judge the matter at hand” means those credentials which qualify a peer reviewer as a member of the involved medical specialty in a particular case.</text> </paragraph> <paragraph num="(40)"> <text>“Stay” means the withholding of disciplinary panel action against a health care provider.</text> </paragraph> <paragraph num="(41)"> <text>“Stet” means the act of staying further action in a proceeding, subject to the proceeding being reopened at a later date.</text> </paragraph> <paragraph num="(42)"> <text>“Summary suspension” means a denial for an indefinite period of the right to use a license.</text> </paragraph> <paragraph num="(43)"> <text>“Surrender” means the voluntary relinquishing of a Board license to a disciplinary panel.</text> </paragraph> <paragraph num="(44)"> <text>“Suspension” means a denial of the right to use a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prehearing Proceedings."> <paragraph num="A."> <text>This regulation applies to:</text> <paragraph num="(1)"> <text>Proceedings under Health Occupations Article, §1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) or 15-315, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>To the extent specifically provided in this regulation, cease and desist orders.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This regulation does not apply to procedures pursuant to Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>Designated staff shall undertake a preliminary investigation regarding an allegation of grounds for disciplinary or other action brought to the Board’s attention before the allegation is assigned to a disciplinary panel.</text> </paragraph> <paragraph num="(2)"> <text>A complaint concerning alleged grounds for discipline of a Board licensee shall be assigned to a disciplinary panel which:</text> <paragraph num="(a)"> <text>Shall review a complaint in light of the preliminary investigation; and</text> </paragraph> <paragraph num="(b)"> <text>May direct further investigation, referral for peer review, closure without charges, or closure with an advisory letter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participation in the complaint review process is not ordinarily a basis for recusal of a disciplinary panel member from further proceedings in the case.</text> </paragraph> <paragraph num="(4)"> <text>Investigative Subpoenas.</text> <paragraph num="(a)"> <text>Except as provided in §C(4)(b) of this regulation, upon the receipt of a timely written request from a psychiatrist who is the subject of a complaint concerning the quality of the psychiatric care provided by that psychiatrist, a quorum of a disciplinary panel shall review a subpoena for mental health records made or held by that psychiatrist before the subpoena is enforced.</text> </paragraph> <paragraph num="(b)"> <text>Section C(4)(a) of this regulation does not apply to:</text> <paragraph num="(i)"> <text>Any subpoena other than an investigative subpoena;</text> </paragraph> <paragraph num="(ii)"> <text>A subpoena issued in response to an investigation opened based upon a patient complaint;</text> </paragraph> <paragraph num="(iii)"> <text>A subpoena issued as a result of a complaint or action by a law enforcement agency;</text> </paragraph> <paragraph num="(iv)"> <text>A subpoena issued as a result of a complaint from a health care professional;</text> </paragraph> <paragraph num="(v)"> <text>A subpoena for records if the executive director or the deputy director determines that there is a reasonable possibility that the records will be destroyed, secreted, lost, or altered if the subpoena is not promptly enforced; or</text> </paragraph> <paragraph num="(vi)"> <text>A subpoena if the executive director or deputy director determines that there is a reasonable possibility of imminent harm to the public health, safety, or welfare, including the health, safety, or welfare of an individual patient.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Section C(4)(b) of this regulation does not affect any rights which an individual may have under Health-General Article, Annotated Code of Maryland, to contest a subpoena in court.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Review by the Peer Reviewers.</text> <paragraph num="(1)"> <text>After being assigned a complaint, a disciplinary panel shall have the matter reviewed by peer reviewers if the complaint concerns an allegation that a physician failed to:</text> <paragraph num="(a)"> <text>Meet the standards of quality medical care; or</text> </paragraph> <paragraph num="(b)"> <text>Keep adequate medical records.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The disciplinary panel shall obtain reports from at least two different peer reviewers in each case for each allegation referred for peer review.</text> </paragraph> <paragraph num="(3)"> <text>If one or both peer reviewers conclude that a violation of the standard of care has occurred, the disciplinary panel shall make the final peer review report, consisting of the reports of each individual peer reviewer, available to the respondent for review before the disciplinary panel considers whether to issue charges. The disciplinary panel shall redact the names of the peer reviewers before making the report available under this section.</text> </paragraph> <paragraph num="(4)"> <text>The respondent may provide a written response to the peer review report within 10 business days after the report was sent to the respondent by electronic mail or 13 business days if the report was sent via U.S. postal service.</text> </paragraph> <paragraph num="(5)"> <text>The disciplinary panel shall:</text> <paragraph num="(a)"> <text>Consider both the final peer review report and any written response submitted within the time period specified in §D(4) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Determine whether there is reasonable cause to charge a respondent with failure to meet appropriate standards of quality care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>Except as provided in §E(2) of this regulation, a disciplinary panel may not bring charges against a licensee based solely on events contained in a complaint the disciplinary panel received more than 6 years after:</text> <paragraph num="(a)"> <text>The day the complainant actually discovered the facts that form the basis of the complaint; or</text> </paragraph> <paragraph num="(b)"> <text>The day when a reasonable person exercising due diligence should have discovered the facts that form the basis of the complaint.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The prohibition in §E(1) of this regulation does not apply to complaints that are based on any of the following:</text> <paragraph num="(a)"> <text>Criminal convictions;</text> </paragraph> <paragraph num="(b)"> <text>Sexual misconduct;</text> </paragraph> <paragraph num="(c)"> <text>Other boundary violations;</text> </paragraph> <paragraph num="(d)"> <text>Reciprocal actions under Health Occupations Article, §14-404(a)(21), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Ongoing substance abuse;</text> </paragraph> <paragraph num="(f)"> <text>Fraudulent concealment of material information; or</text> </paragraph> <paragraph num="(g)"> <text>Acts that occurred while a patient was a minor.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>After reviewing the completed investigative information and reports, a disciplinary panel shall make its determination to:</text> <paragraph num="(a)"> <text>Close a complaint investigation without charges;</text> </paragraph> <paragraph num="(b)"> <text>Take informal action by issuing a nonpublic advisory letter;</text> </paragraph> <paragraph num="(c)"> <text>Request the respondent to enter into a disposition agreement with the disciplinary panel if the respondent suffers from substance abuse or a physical, mental, or emotional condition which may otherwise jeopardize medical care;</text> </paragraph> <paragraph num="(d)"> <text>Except as provided in §E(1) of this regulation, vote to charge a respondent with a violation of a ground under Health Occupations Article, §14-404, Annotated Code of Maryland, or COMAR 10.32.07, or another statute which gives the Board or disciplinary panel authority;</text> </paragraph> <paragraph num="(e)"> <text>Vote to deny administrative reinstatement; or</text> </paragraph> <paragraph num="(f)"> <text>Accept a surrender on terms acceptable to the disciplinary panel.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Summary Suspension.</text> <paragraph num="(a)"> <text>In addition to charging, the disciplinary panel assigned to the complaint may vote to summarily suspend or vote an intent to summarily suspend the license of the respondent pursuant to State Government Article, §10-226(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>A vote to summarily suspend the license of the respondent may be taken before the disciplinary panel charges the respondent.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>After a vote to take formal action under §E(3)(d) or (e) and (4) of this regulation, the disciplinary panel shall refer the matter to the administrative prosecutor for prosecutorial action.</text> </paragraph> <paragraph num="(6)"> <text>Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration.</text> </paragraph> <paragraph num="(7)"> <text>If the disciplinary panel issues charges, the disciplinary panel shall serve it upon the respondent by regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice. The disciplinary panel may delegate the issuance and service of the charges to the administrative prosecutor.</text> </paragraph> <paragraph num="(8)"> <text>The disciplinary panel, in the notice of administrative reinstatement, shall provide the respondent with an opportunity to request a hearing within 30 days from receipt of service.</text> </paragraph> <paragraph num="(9)"> <text>Disciplinary Committee for Case Resolution (DCCR).</text> <paragraph num="(a)"> <text>After service of the charging document, the respondent and the complainant shall be offered a meeting with the disciplinary panel that was originally assigned the complaint and which sits as a DCCR. The meeting is a voluntary, informal settlement, proceeding to explore the possibility of a consent order or other resolution of the matter. The proceedings concerning a summary suspension are governed by Regulation .08 of this chapter and do not entail a meeting before a DCCR.</text> </paragraph> <paragraph num="(b)"> <text>If the respondent and the administrative prosecutor each do not agree with the proposed settlement offered by the DCCR, the matter proceeds to a hearing before the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(c)"> <text>Except for the DCCRs consideration of a proposed resolution of a case achieved through the conference with the DCCR, the disciplinary panel, the parties, and the complainant may not make use of any commentary, admissions, facts revealed, or positions taken, including any disposition recommended by the DCCR, in the subsequent stages of the disciplinary proceedings unless the subject matter is available from other sources or is otherwise discovered. The respondent, administrative prosecutor, and complainant are prohibited from revealing this material.</text> </paragraph> <paragraph num="(d)"> <text>The complainant and respondent may attend and participate as authorized by statute. The complainant may be accompanied by Board staff but not by any other person.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Representation; Parties.</text> <paragraph num="(1)"> <text>The respondent may appear in proper person or be represented by counsel in any matter before a disciplinary panel and during any stage of the disciplinary proceedings. The respondent may be represented only by an attorney admitted to the Maryland Bar or specially admitted to practice law in Maryland under Rule 14 of the Maryland Rules Governing Admissions to the Bar found in the Maryland Rules.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor shall present evidence and argument at an evidentiary hearing on the charges and arguments before a disciplinary panel in the exceptions process as specified in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The administrative prosecutor is a party to the administrative proceedings:</text> <paragraph num="(a)"> <text>As soon as formal charges are issued; and</text> </paragraph> <paragraph num="(b)"> <text>Until a disciplinary panel’s final decision is issued.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board or a disciplinary panel is not a party to the proceedings before an administrative law judge.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Chair, or the Chair’s designee, of a disciplinary panel assigned the complaint may issue orders necessary to regulate the proceedings under this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Adjudication of Allegations in a Charging Document."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>This regulation applies to cases under Health Occupations Article, §§1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) and 15-315 Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>This regulation does not apply to cases under Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, or to cease and desist orders issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Delegation.</text> <paragraph num="(1)"> <text>If the charges are not resolved with the DCCR, the chair of the DCCR shall refer the case to the other disciplinary panel which shall delegate to an administrative law judge responsibility to make:</text> <paragraph num="(a)"> <text>Proposed findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed findings of fact and proposed conclusions of law; or</text> </paragraph> <paragraph num="(c)"> <text>Proposed findings of fact, proposed conclusions of law, and proposed disposition.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the disciplinary panel has delegated the case to the Office of Administrative Hearings for the issuance of proposed findings of fact only, the following apply:</text> <paragraph num="(a)"> <text>The delegation to the Office of Administrative Hearings is limited to making proposed findings of fact on allegations which are disputed;</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel may rescind the delegation if:</text> <paragraph num="(i)"> <text>The parties jointly notify the disciplinary panel prior to the prehearing conference, or the administrative law judge notifies the disciplinary panel prior to the occurrence of the factors set out in State Government Article, §10-205(d)(2), Annotated Code of Maryland, that there are no substantial factual allegations in dispute;</text> </paragraph> <paragraph num="(ii)"> <text>The notification recites the facts which are undisputed; and</text> </paragraph> <paragraph num="(iii)"> <text>The disciplinary panel determines that the facts agreed upon are sufficient to decide the issue; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If a delegation to the Office of Administrative Hearings has been rescinded pursuant to §B(2)(b) of this regulation, the disciplinary panel shall set the case on the disciplinary panel docket for the disciplinary panel to issue conclusions of law and a disposition based on the undisputed material facts, after giving the parties a reasonable opportunity for written and oral argument.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the disciplinary panel has delegated the case to the Office of Administrative Hearings for the issuance of proposed findings of fact and conclusions of law only, the following apply:</text> <paragraph num="(a)"> <text>The delegation to the Office of Administrative Hearings is limited to making proposed findings of fact and conclusions of law on allegations which are disputed; and</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel may rescind the delegation if:</text> <paragraph num="(i)"> <text>The parties jointly notify the disciplinary panel prior to the prehearing conference, or the administrative law judge notifies the disciplinary panel prior to the occurrence of the factors set out in State Government Article, §10-205(d)(2), Annotated Code of Maryland, that there are no substantial factual allegations or conclusions of law in dispute;</text> </paragraph> <paragraph num="(ii)"> <text>The notification recites the facts and conclusions of law which are undisputed; and</text> </paragraph> <paragraph num="(iii)"> <text>The disciplinary panel determines that the facts and conclusions of law agreed upon are sufficient to decide the issue.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If a delegation to the Office of Administrative Hearings has been rescinded pursuant to §B(3)(b) of this regulation, the disciplinary panel shall set the case on the disciplinary panel docket for the disciplinary panel to issue a disposition based on the undisputed material facts and conclusions of law, after giving the parties a reasonable opportunity for written and oral argument.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel may rescind a delegation to an administrative law judge if prior to the start of the evidentiary hearing:</text> <paragraph num="(a)"> <text>The parties execute a proposed consent order settling all aspects of the case; and</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel initially assigned the complaint agrees to that proposed consent order.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. In addition to any disclosures required by §C(2) or (3) of this regulation, by written request served on the other party and filed with the administrative law judge, a party may require another party to produce, within 15 calendar days, the following:</text> <paragraph num="(a)"> <text>A list of witnesses to be called; and</text> </paragraph> <paragraph num="(b)"> <text>Copies of documents intended to be produced at the hearing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Notice of Specific Defenses in Cases Involving the Standard of Quality Care.</text> <paragraph num="(a)"> <text>The respondent shall notify the administrative prosecutor not later than 45 days after the issuance of charges of any statement made to the respondent by the patient which was not recorded in the respondent’s medical record of the patient, and which affected the patient’s course of treatment, including but not limited to:</text> <paragraph num="(i)"> <text>Any refusal of hospitalization or treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Any report of symptoms;</text> </paragraph> <paragraph num="(iii)"> <text>Any report of the effects of medication;</text> </paragraph> <paragraph num="(iv)"> <text>Any report by the patient of consultations or treatment by other health care providers; and</text> </paragraph> <paragraph num="(v)"> <text>Any expressions by the patient of a preference for one course of treatment over another.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The respondent shall notify the administrative prosecutor not later than 45 days after the issuance of charges of:</text> <paragraph num="(i)"> <text>Any consultation concerning the patient, formal or informal, with any other health care provider, which is not recorded in the patient’s medical record; or</text> </paragraph> <paragraph num="(ii)"> <text>Any communication with family members of the patient which affected the patient’s course of treatment, and which is not recorded in the patient’s medical record.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The notices required by §C(2)(a) and (b) of this regulation shall be in writing and shall state:</text> <paragraph num="(i)"> <text>The name of the declarant or consultant;</text> </paragraph> <paragraph num="(ii)"> <text>The substance of the declaration or consultant report; and</text> </paragraph> <paragraph num="(iii)"> <text>The date on which each communication took place.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Unless the respondent has provided the notice required by §C(2) of this regulation, the administrative law judge shall exclude from the hearing any evidence described in §C(2)(a) or (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days prior to the prehearing conference or 45 days prior to the scheduled hearing, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report prepared and signed by the expert summarizing the expert’s testimony, which includes the opinion offered and the factual basis and the reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the administrative law judge finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the administrative law judge shall exclude from the hearing:</text> <paragraph num="(i)"> <text>The testimony of the expert; and</text> </paragraph> <paragraph num="(ii)"> <text>Any report of the expert.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The administrative law judge shall consider and decide arguments concerning the sufficiency of the report at the prehearing conference and may require that the report be timely amended, if insufficient, to allow the opposing party ample opportunity to prepare for hearing.</text> </paragraph> <paragraph num="(d)"> <text>If an expert adopts the written report of the disciplinary panel’s peer reviewer or reviewers, or adopts a sufficiently specific charging document as the expert’s report, that adoption is considered to satisfy the requirements set forth in §C(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Parties are not entitled to discovery of items except as listed in §C(1), (2), or (3) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>Subject to §C(7) of this regulation, both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(6)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list subsequent to:</text> <paragraph num="(a)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>If no prehearing conference is scheduled, 15 days prior to the hearing.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The prohibition from adding witnesses subsequent to the prehearing conference does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Hearing.</text> <paragraph num="(1)"> <text>Unless the delegation has been rescinded according to §B(2), (3), or (4) of this regulation, the administrative law judge shall conduct an evidentiary hearing governed by the Administrative Procedure Act and COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>Evidence otherwise admissible under COMAR 28.02.01 may not be excluded solely on the ground that the evidence is not recited in the charging document.</text> </paragraph> <paragraph num="(3)"> <text>During these proceedings, the administrative law judge shall treat all records except for a charging document as confidential and sealed.</text> </paragraph> <paragraph num="(4)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, §C of this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In the event of a conflict between §C of this regulation and COMAR 28.02.01, §C of this regulation shall apply.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The administrative law judge shall issue to the disciplinary panel, that delegated the case to the ALJ, a written proposed decision including, where applicable, proposed findings of fact, proposed conclusions of law, and a proposed disposition after the conclusion of the hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disciplinary Panel Exceptions Process and Final Order."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>This regulation applies to cases under Health Occupations Article, §§1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) and 15-315 Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>This regulation does not apply to cases under Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-14(c), 14-5D-14(b), 14-5E-16(f), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, or to cease and desist orders issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Exceptions.</text> <paragraph num="(1)"> <text>Written Exceptions.</text> <paragraph num="(a)"> <text>Any party may file with the disciplinary panel, that delegated the case to an administrative law judge, exceptions to a proposed decision of an administrative law judge within 15 days of its issuance. A party may file a response to any exceptions within 15 days of the date the exceptions are filed. The disciplinary panel may extend the period for filing exceptions and responses. The disciplinary panel may grant a party filing exceptions the opportunity to file a reply to a response within a stated period of time as determined by the disciplinary panel in any specific case. No further exceptions or responses of any kind may be accepted.</text> </paragraph> <paragraph num="(b)"> <text>Format.</text> <paragraph num="(i)"> <text>Written exceptions and responses to exceptions are limited to 15 pages in length, double-spaced and in at least 12-point type, and with margins of at least 1 inch.</text> </paragraph> <paragraph num="(ii)"> <text>Any reply to responses to exceptions is limited to five pages in the same format.</text> </paragraph> <paragraph num="(iii)"> <text>If a party attaches any part of the record to the exceptions, response, or reply, the attached pages are not to be encompassed within the applicable page limit. The disciplinary panel may require the attachment of those parts of the record cited in the exceptions in a form designated by the Board.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Exceptions, responses, and replies may refer to the record by citing the exhibit number or the transcript page.</text> </paragraph> <paragraph num="(d)"> <text>The disciplinary panel chair or the disciplinary panel chair’s designee may in each case rule on specific procedural issues with respect to written exceptions.</text> </paragraph> <paragraph num="(e)"> <text>The disciplinary panel may not accept additional evidence through the written exceptions process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Oral Exceptions Hearing.</text> <paragraph num="(a)"> <text>If either party files exceptions, the disciplinary panel shall schedule a hearing, ordinarily 30 days after the receipt of responses to the exceptions, after which the disciplinary panel shall issue an order containing the disciplinary panel’s findings of fact, conclusions of law, and disposition.</text> </paragraph> <paragraph num="(b)"> <text>The presiding disciplinary panel member, usually the disciplinary panel chair, shall:</text> <paragraph num="(i)"> <text>Determine all procedural issues that are governed by this section;</text> </paragraph> <paragraph num="(ii)"> <text>Make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing; and</text> </paragraph> <paragraph num="(iii)"> <text>Ordinarily limit oral presentation by the respondent and the administrative prosecutor to 20 minutes each.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The party who filed the first exceptions shall ordinarily proceed first.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Additional Evidence. At the oral exceptions hearing, the disciplinary panel may not accept additional evidence unless:</text> <paragraph num="(a)"> <text>Both parties consent to the admission of additional documentary evidence and the disciplinary panel determines that acceptance of the additional evidence would promote the just and efficient completion of the process; or</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel determines that either:</text> <paragraph num="(i)"> <text>A compelling reason exists that would create an obvious injustice if the additional documentary evidence were not considered and the evidence can be admitted without compromising the rights of the other party, including the other party’s opportunity to see the proffered evidence in a timely manner or cross-examine the source of the proffered document and present evidence to the contrary; or</text> </paragraph> <paragraph num="(ii)"> <text>The evidence has been timely proffered before the administrative law judge and the administrative law judge abused his or her discretion in refusing to admit the evidence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the parties do not file exceptions, the disciplinary panel shall consider the record, including the proposed decision of the administrative law judge, and issue its order based on the disciplinary panel’s findings of fact and conclusions of law.</text> </paragraph> <paragraph num="(5)"> <text>A Board staff member who testified at the hearing before the administrative law judge may not be present during disciplinary panel deliberations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Board Action.</text> <paragraph num="(1)"> <text>Final Order. The disciplinary panel shall issue a final order within 90 days after the conclusion of:</text> <paragraph num="(a)"> <text>An exceptions hearing; or</text> </paragraph> <paragraph num="(b)"> <text>Other formal disciplinary panel proceedings.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Effect of Revocation Order.</text> <paragraph num="(a)"> <text>When a time period is not stated in an order for revocation, the disciplinary panel may not entertain an application for postdisciplinary reinstatement until at least 3 years after the date of the order.</text> </paragraph> <paragraph num="(b)"> <text>A revocation of a license may not be for less than 1 year and may be permanent.</text> </paragraph> <paragraph num="(c)"> <text>The disciplinary panel may not entertain an application for postdisciplinary reinstatement after an order of revocation unless:</text> <paragraph num="(i)"> <text>Any time period stated in the order has expired;</text> </paragraph> <paragraph num="(ii)"> <text>The conditions set out in the order have been fulfilled;</text> </paragraph> <paragraph num="(iii)"> <text>The applicant has filed a formal application and paid the fee; and</text> </paragraph> <paragraph num="(iv)"> <text>The applicant meets all of the requirements for reinstatement set out in COMAR 10.32.01.10.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The disciplinary panel that issued the final order revoking or suspending the respondent shall entertain applications for reinstatement pursuant to the procedures and standards of Regulation .06B of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Tolling.</text> <paragraph num="(a)"> <text>Except as a disciplinary panel order directs otherwise in a specific case, if a licensee subject to probation or suspension fails to renew a license:</text> <paragraph num="(i)"> <text>The failure to renew the license does not remove the suspension or probation from the licensee’s disciplinary record during the period of nonrenewal;</text> </paragraph> <paragraph num="(ii)"> <text>Any condition of probation or condition precedent to terminating a suspension that is dependent on possessing a license is tolled until the probationer or suspended licensee again possesses a license; and</text> </paragraph> <paragraph num="(iii)"> <text>The time period of probation or suspension, if any, is tolled until the probationer or suspended licensee again possesses a license.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Section C(3)(a) of this regulation does not:</text> <paragraph num="(i)"> <text>Apply to fines; or</text> </paragraph> <paragraph num="(ii)"> <text>Require the disciplinary panel to reinstate any former licensee.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Post Disciplinary Reinstatement of a License."> <paragraph num="A."> <text>Postdisciplinary reinstatement after an order of suspension is subject to the following conditions:</text> <paragraph num="(1)"> <text>If an order suspends a license for a certain period of time, the respondent may petition the disciplinary panel that issued the order to suspend for postdisciplinary reinstatement only pursuant to that order;</text> </paragraph> <paragraph num="(2)"> <text>The disciplinary panel may not entertain early termination of the suspension;</text> </paragraph> <paragraph num="(3)"> <text>If termination of a suspension is made contingent on the happening of an event, the respondent shall establish the occurrence of the event to the satisfaction of the disciplinary panel; and</text> </paragraph> <paragraph num="(4)"> <text>If a health care practitioner whose license is suspended fails to renew the suspended license when that license expires, the health care practitioner may petition the disciplinary panel for termination of suspension only after applying for and meeting the requirements for reinstatement set out in COMAR 10.32.01.10.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Postdisciplinary reinstatement of a revoked or surrendered license is subject to the following conditions:</text> <paragraph num="(1)"> <text>A petitioner for postdisciplinary reinstatement of a revoked or surrendered license shall submit the following:</text> <paragraph num="(a)"> <text>A written application for reinstatement on a form prescribed by the Board;</text> </paragraph> <paragraph num="(b)"> <text>The appropriate fee;</text> </paragraph> <paragraph num="(c)"> <text>Written responses to any questions the disciplinary panel may propose concerning the reasons the license was revoked or surrendered and the petitioner’s current fitness to practice; and</text> </paragraph> <paragraph num="(d)"> <text>Evidence of the completion of continuing medical education credits to the same extent as if the petitioner had been continuously licensed;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a license was revoked or surrendered while the licensee was under investigation or subject to disciplinary charges, the disciplinary panel may not consider the application for postdisciplinary reinstatement unless:</text> <paragraph num="(a)"> <text>If the letter of surrender indicates that the surrender or the revocation order is for a certain length of time, the time period has expired; or</text> </paragraph> <paragraph num="(b)"> <text>If the letter of surrender or revocation order does not indicate a time certain, 3 years have passed since the date of the order; and</text> </paragraph> <paragraph num="(c)"> <text>If the letter of surrender makes reinstatement contingent on certain conditions, those conditions have occurred;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The disciplinary panel may grant postdisciplinary reinstatement of a revoked or surrendered license only in accordance with the terms of the order of revocation or the letter of surrender;</text> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel may grant postdisciplinary reinstatement subject to any terms and conditions the disciplinary panel considers appropriate for public safety and the protection of the integrity and reputation of the profession;</text> </paragraph> <paragraph num="(5)"> <text>The disciplinary panel that issued the order to revoke or suspend may convene a reinstatement inquiry panel which:</text> <paragraph num="(a)"> <text>May conduct an informal inquiry which shall include, if requested, an opportunity for the petitioner to have a personal interview with the panel;</text> </paragraph> <paragraph num="(b)"> <text>May consider the petitioner’s history; and</text> </paragraph> <paragraph num="(c)"> <text>May consider presentations from both the petitioner and the administrative prosecutor’s office.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The disciplinary panel shall consider the application form, the petitioner’s responses to the written questions, and the supporting documentation and written arguments, if any, submitted by the petitioner and the administrative prosecutor’s office, as well as the reinstatement inquiry panel’s recommendation;</text> </paragraph> <paragraph num="(7)"> <text>The disciplinary panel shall determine in its discretion if postdisciplinary reinstatement is in the interest of the health and welfare of the general public and consistent with the best interest of the profession; and</text> </paragraph> <paragraph num="(8)"> <text>A disciplinary panel decision denying reinstatement may set out when, if ever, a subsequent petition may be submitted.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The disciplinary panel shall issue a final written order on the postdisciplinary reinstatement application that:</text> <paragraph num="(1)"> <text>Reinstates the license of the petitioner without conditions;</text> </paragraph> <paragraph num="(2)"> <text>Reinstates the license of the petitioner with one or more of the following conditions:</text> <paragraph num="(a)"> <text>Probation;</text> </paragraph> <paragraph num="(b)"> <text>Requirements for supervision;</text> </paragraph> <paragraph num="(c)"> <text>Further review of competence or performance;</text> </paragraph> <paragraph num="(d)"> <text>Limitations on practice; or</text> </paragraph> <paragraph num="(e)"> <text>Other conditions that the disciplinary panel considers necessary; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Denies reinstatement.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An order granting or denying postdisciplinary reinstatement is an order resulting from formal disciplinary action.</text> </paragraph> <paragraph num="E."> <text>A petition for postdisciplinary reinstatement may be withdrawn only with the permission of the disciplinary panel. The disciplinary panel may not refund the fee except for extraordinary cause.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Proceedings under Health Occupations Article, §§14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) and 15-314(b), Annotated Code of Maryland."> <paragraph num="A."> <text>In this regulation, “health care provider” means an individual who is a:</text> <paragraph num="(1)"> <text>Licensed physician;</text> </paragraph> <paragraph num="(2)"> <text>Licensed respiratory care practitioner;</text> </paragraph> <paragraph num="(3)"> <text>Licensed radiographer;</text> </paragraph> <paragraph num="(4)"> <text>Licensed nuclear medical technologist;</text> </paragraph> <paragraph num="(5)"> <text>Licensed radiation therapist;</text> </paragraph> <paragraph num="(6)"> <text>Licensed radiologist assistant;</text> </paragraph> <paragraph num="(7)"> <text>Licensed polysomnographic technologist;</text> </paragraph> <paragraph num="(8)"> <text>Licensed athletic trainer;</text> </paragraph> <paragraph num="(9)"> <text>Licensed perfusionist;</text> </paragraph> <paragraph num="(10)"> <text>Licensed naturopathic doctor; or</text> </paragraph> <paragraph num="(11)"> <text>Licensed physician assistant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Health Occupations Article, §§14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) and 15-314(b), Annotated Code of Maryland, govern mandatory actions of the suspension or revocation of a license on the filing of certified docket entries, if the health care provider is convicted of or pleads guilty, including by an Alford plea, or a plea of nolo contendere to a crime involving moral turpitude.</text> </paragraph> <paragraph num="C."> <text>Procedures.</text> <paragraph num="(1)"> <text>The Office of the Attorney General through Board counsel shall provide to the disciplinary panel assigned to the case certified docket entries of the criminal court proceeding and the following documents from the court record:</text> <paragraph num="(a)"> <text>For a conviction, at least:</text> <paragraph num="(i)"> <text>The indictment, information, or other formal statement of the charges; and</text> </paragraph> <paragraph num="(ii)"> <text>Documentation of the verdict and sentencing; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a plea of guilty, including an Alford plea, or a plea of nolo contendere, at least one of the following:</text> <paragraph num="(i)"> <text>Stipulated statement of facts or statement of facts on the record;</text> </paragraph> <paragraph num="(ii)"> <text>Plea agreement containing agreed facts;</text> </paragraph> <paragraph num="(iii)"> <text>Transcript of plea agreement proceedings; or</text> </paragraph> <paragraph num="(iv)"> <text>Written or transcribed opinion or statement of the judge accepting the plea.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>When the disciplinary panel determines that documents provided to it indicate that the respondent comes within the language and intent of Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, and the disciplinary panel has a basis for finding preliminarily that it applies to the respondent, the disciplinary panel shall vote to issue an order requiring the respondent to show cause why the disciplinary panel should not take action under this section.</text> </paragraph> <paragraph num="(3)"> <text>After the vote to issue the show cause order, the disciplinary panel shall refer the matter to the administrative prosecutor for prosecutorial action.</text> </paragraph> <paragraph num="(4)"> <text>Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Service.</text> <paragraph num="(1)"> <text>The disciplinary panel shall serve the respondent by regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice.</text> </paragraph> <paragraph num="(2)"> <text>The disciplinary panel may choose to serve the respondent personally.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Opportunity to be Heard.</text> <paragraph num="(1)"> <text>The respondent, after service of the show cause order, has 30 days in which to respond.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may show cause in writing on the following issues:</text> <paragraph num="(a)"> <text>Lack of conviction or plea;</text> </paragraph> <paragraph num="(b)"> <text>Whether the crime is one involving moral turpitude;</text> </paragraph> <paragraph num="(c)"> <text>Misidentity of the respondent with the defendant in the criminal matter; and</text> </paragraph> <paragraph num="(d)"> <text>Other relevant issues, if any, other than mitigation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The respondent may also, within 30 days of service of the show cause order, request an opportunity to address the disciplinary panel by a limited evidentiary hearing on the same issues. However, this argument may not be as of right, but is discretionary based on the existence of genuine issues of material fact or law as determined by the disciplinary panel.</text> </paragraph> <paragraph num="(4)"> <text>The presiding disciplinary panel member, usually the disciplinary panel chair, shall determine all procedural issues that are governed by this section, and may impose reasonable time limitations. The presiding disciplinary panel member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. Ordinarily, the respondent and the administrative prosecutor shall limit their oral presentation to 20 minutes each. The respondent shall proceed first.</text> </paragraph> <paragraph num="(5)"> <text>The presiding disciplinary panel member shall allow for consideration of documents the presiding disciplinary panel member determines relevant and material. The presiding disciplinary panel member may not admit oral testimony or witnesses.</text> </paragraph> <paragraph num="(6)"> <text>Disciplinary panel members may ask questions of any party appearing before the disciplinary panel.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Representation.</text> <paragraph num="(1)"> <text>The respondent may appear in proper person or be represented by counsel.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor shall present argument in support of the proposed sanction.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>The respondent may argue issues as set out in §E(2) of this regulation and has the burden of producing argument or evidence in response to the show cause order.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of persuasion by a preponderance of the evidence that the respondent was convicted of or pled guilty or nolo contendere to a crime of moral turpitude.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Disciplinary Panel Action.</text> <paragraph num="(1)"> <text>After consideration of the respondent’s answer, either in writing or at a hearing, the disciplinary panel shall deliberate and determine whether the crime is a crime involving moral turpitude, and then shall issue an appropriate order.</text> </paragraph> <paragraph num="(2)"> <text>A pending appeal of the conviction or plea does not operate as a bar to the disciplinary panel’s acting under Health Occupations Article, §14-404(b)(1), 14-5A-17(c)(1), 14-5B-14(c)(1), 14-5C-17(c), 14-5D-14(b)(1), 14-5E-16(c), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>A respondent suspended pursuant to Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b)(1), 14-5E-16(e), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, shall be reinstated immediately upon the filing of a certified docket entry that the conviction has been reversed. The reinstatement does not terminate any other disciplinary action or investigation pending against the respondent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Summary Suspension."> <paragraph num="A."> <text>State Government Article, §10-226(c), Annotated Code of Maryland, governs consideration of summary suspension of a license.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered during an investigation, the disciplinary panel may determine that there is a substantial likelihood of a risk of serious harm to the public health, safety, or welfare by the health provider, and vote an intent to summarily suspend the license of the respondent.</text> </paragraph> <paragraph num="(2)"> <text>If the disciplinary panel votes an intent to summarily suspend, the Board shall refer the matter to the administrative prosecutor for prosecutorial action.</text> </paragraph> <paragraph num="(3)"> <text>Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration.</text> </paragraph> <paragraph num="(4)"> <text>Notice to the respondent includes a:</text> <paragraph num="(a)"> <text>Proposed order for summary suspension; and</text> </paragraph> <paragraph num="(b)"> <text>Show cause notice letter providing an opportunity to the respondent to show cause why the order should not be issued.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The proposed order for summary suspension includes but is not limited to:</text> <paragraph num="(a)"> <text>The statutory authority upon which the order is based;</text> </paragraph> <paragraph num="(b)"> <text>Notification that the respondent may request a full hearing to appeal the summary suspension, if executed by the disciplinary panel; and</text> </paragraph> <paragraph num="(c)"> <text>Statements of investigatory information which serve as a basis for the order.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Service.</text> <paragraph num="(a)"> <text>The disciplinary panel shall serve the respondent:</text> <paragraph num="(i)"> <text>At least 5 calendar days before a predeprivation hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>By regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel may choose to serve the respondent personally.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A show cause notice may not be required in extraordinary circumstances. The disciplinary panel, after consultation with the Board’s counsel, may suspend a license without prior notice and opportunity to be heard, if:</text> <paragraph num="(a)"> <text>The disciplinary panel determines that the health, welfare, and safety of the public or the physician imperatively requires immediate suspension;</text> </paragraph> <paragraph num="(b)"> <text>Notice and opportunity to be heard before the action is not feasible; and</text> </paragraph> <paragraph num="(c)"> <text>The respondent is provided with a postdeprivation opportunity to be heard within 15 days by the disciplinary panel, that voted to summarily suspend the license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Representation.</text> <paragraph num="(1)"> <text>The respondent may appear in proper person or be represented by counsel in any matter before the disciplinary panel. If represented at an evidentiary hearing, the respondent shall be represented only by an attorney admitted to the Maryland Bar or specially admitted to practice law in Maryland under Rule 14 of the Rules Governing Admission to the Bar found in the Maryland Rules.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor shall appear in prosecution of the case.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Predeprivation Hearing Before the Disciplinary Panel.</text> <paragraph num="(1)"> <text>The disciplinary panel, that voted to issue a show cause order, shall hold the predeprivation hearing on whether to summarily suspend the license. The presiding disciplinary panel member shall determine all procedural issues that are governed by this section, and may impose reasonable time limitations. The presiding disciplinary panel member may make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing, and shall limit the oral presentation by the respondent and the administrative prosecutor to 20 minutes each. The respondent shall proceed first.</text> </paragraph> <paragraph num="(2)"> <text>The presiding disciplinary panel member:</text> <paragraph num="(a)"> <text>Shall allow for consideration of oral presentations and documents considered by the presiding disciplinary panel member to be relevant and material to the proceeding and not unduly repetitious; and</text> </paragraph> <paragraph num="(b)"> <text>May not admit oral testimony or witnesses.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The disciplinary panel members may ask any questions of any party appearing before the disciplinary panel.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the disciplinary panel proceeds under §B(7) of this regulation, the disciplinary panel shall hold a postdeprivation initial hearing. The disciplinary panel shall conduct the hearing in accordance with §D of this regulation unless the parties waive this hearing and proceed to the summary suspension appeal.</text> </paragraph> <paragraph num="F."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>The respondent may present argument in opposition to allegations presented in the proposed order for summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden to show by a preponderance of the evidence that the health, welfare, and safety of the public imperatively requires the disciplinary panel to issue an order to suspend the respondent’s license.</text> </paragraph> </paragraph> <paragraph num="G."> <text>After the predeprivation hearing, the disciplinary panel shall vote to:</text> <paragraph num="(1)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter any order to which the parties may agree; or</text> </paragraph> <paragraph num="(4)"> <text>Enter any interim order which the circumstances of the case warrant.</text> </paragraph> </paragraph> <paragraph num="H."> <text>After the postdeprivation hearing, the disciplinary panel shall vote to:</text> <paragraph num="(1)"> <text>Reaffirm the summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Rescind the summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter any order to which the parties may agree; or</text> </paragraph> <paragraph num="(4)"> <text>Enter any interim order which the circumstances of the case warrant.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The respondent may demand a full evidentiary hearing on the merits within 10 days of the issuance of a summary suspension order, and the Office of Administrative Hearings shall set a hearing within 30 days of the demand.</text> </paragraph> <paragraph num="J."> <text>Evidentiary Hearing Before the Administrative Law Judge.</text> <paragraph num="(1)"> <text>The appeal from a summary suspension shall be an evidentiary hearing under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(2)"> <text>After a full evidentiary hearing, the administrative law judge shall issue a proposed decision with findings of fact, conclusions of law and disposition. The administrative prosecutor and respondent may file exceptions in accordance with Regulation .05B of this chapter. If a party files exceptions, unless the exceptions hearing is waived, an exceptions hearing, on the record, shall be held before the disciplinary panel that had not issued the order of summary suspension. After the disciplinary panel issues its final order, the respondent may appeal this decision in accordance with Regulation .12 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Sanctioning and Imposition of Fines."> <paragraph num="A."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections A and B of this regulation and Regulation .10 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B of this regulation, for violations of Health Occupations Article, §§14-404(a), 14-504 and 1-302, Annotated Code of Maryland, the disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §A(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(d)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction.</text> </paragraph> <paragraph num="(e)"> <text>The addition of a fine does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .10 of this chapter, in order to resolve a pending disciplinary action, the disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the disciplinary panel, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §B(5) and (6) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If the disciplinary panel imposes a sanction that departs from the sanctioning guidelines set forth in Regulation .10 of this chapter, the disciplinary panel shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §B(5) and (6) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the disciplinary panel or an administrative law judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>A departure from the sanctioning guidelines set forth in Regulation .10 of this chapter is not a ground for any hearing or appeal of a disciplinary panel action.</text> </paragraph> <paragraph num="(4)"> <text>The existence of one or more of these factors does not impose on the disciplinary panel or an administrative law judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(5)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the disciplinary panel and was cooperative during the disciplinary panel proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified or destroyed evidence, or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Fines for Unauthorized Practice of Medicine.</text> <paragraph num="(1)"> <text>The Board may impose a fine as provided in §C(3) of this regulation for:</text> <paragraph num="(a)"> <text>Practicing medicine without a license in violation of Health Occupations Article, §14-601, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A violation of an order of cease and desist from practicing medicine without a license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Factors in determining the amount of a fine include, but are not limited to the following:</text> <paragraph num="(a)"> <text>The extent to which the respondent derived any financial benefit from the improper conduct;</text> </paragraph> <paragraph num="(b)"> <text>The willfulness of the improper conduct;</text> </paragraph> <paragraph num="(c)"> <text>The extent of actual or potential public harm caused by the improper conduct; and</text> </paragraph> <paragraph num="(d)"> <text>The deterrent effect of the fine.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Range of Fines Imposed.</text> <paragraph num="(a)"> <text>Except as specified in §C(3)(b) of this regulation, the Board may impose fines as follows:</text> <paragraph num="(i)"> <text>For the first violation, not less than $1,000 and not more than $30,000;</text> </paragraph> <paragraph num="(ii)"> <text>For the second violation, not less than $10,000 and not more than $40,000; and</text> </paragraph> <paragraph num="(iii)"> <text>For the third violation, not less than $15,000 and not more than $50,000.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the conduct resulted in harm to any patient, the Board may consider each patient seen to be a separate violation when imposing a fine listed in §C(3)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall pay all monies collected pursuant to this section into the Board’s fund.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Other Fines.</text> <paragraph num="(1)"> <text>The disciplinary panel shall impose a fine of $100 for a violation of Health Occupations Article, §14-505, Annotated Code of Maryland, and a fine of $100 for a violation of Health Occupations Article, §14-316(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The disciplinary panel shall pay all monies collected pursuant to §D(1) of this regulation into the Board’s fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Offenses Related to Continuing Medical Education Credits.</text> <paragraph num="(1)"> <text>First Offense of Failure to Document Credits.</text> <paragraph num="(a)"> <text>Except as provided in §E(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the disciplinary panel may impose a civil fine under Health Occupations Article, §14-316(d)(5), 14-5A-13(d)(2), 14-5B-12(d)(2), 14-5D-12(g), or 15-307(f), Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-404, 14-5A-17, 14-5B-14, 14-5D-14, or 15-314, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Section E(1)(a) of this regulation does not limit the Board’s or disciplinary panel’s authority to require completion of the missing continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19), or 15-314(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-404(a)(11), 14-5A-17(a)(10), 14-5B-14(a)(10), 14-5C-17(a)(10), 14-5D-14(a)(10), 14-5E-16(a)(10), 14-5F-18(a)(9), or 15-314(a)(11), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-404(a)(36) or 15-314(a)(36), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-404(a), 14-405.1, 14-5A-17, 14-5B-17, 14-5C-17, 14-5D-14, 14-5E-16, 14-5F-18, 15-314, or 15-316, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees Previously Disciplined Under §E(1) or (2) of this Regulation.</text> <paragraph num="(a)"> <text>If a licensee has been previously fined or otherwise disciplined under §E(1) or (2) of this regulation, the disciplinary panel may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19) or 15-314(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-404(a)(11), 14-5A-17(a)(10), 14-5B-14(a)(10), 14-5C-17(a)(10), 14-5D-14(a)(10), 14-5E-16(a)(10), 14-5F-18(a)(9), or 15-314(a)(11), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-404(a)(36) or 15-314(a)(36), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-404(a), 14-405.1, 14-5A-17, 14-5B-17, 14-5C-17, 14-5D-14, 14-5E-16, 14-5F-18, 15-314, or 15-316, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(c)"> <text>The disciplinary panel may not apply the sanction described in §E(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel shall pay all monies collected pursuant to this section into the State’s General Fund.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the disciplinary panel any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the disciplinary panel pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the disciplinary panel pursuant to this regulation, the disciplinary panel may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the disciplinary panel may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Sanctioning Guidelines for Physicians."> <paragraph num="A."> <text>Subject to provisions of Regulation .09A and B of this chapter, the disciplinary panel may impose sanctions as outlined in §B of this regulation on physicians for violations of Health Occupations Article, §§14-404(a), 14-504, and 1-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Disciplinary Actions and Licensure Denials Assigned to the Board."> <paragraph num="A."> <text>This regulation applies to proceedings under Health Occupations Article, §14-205(b)(1)(iii), 14-206(e), 14-307, 14-405, 14-606(a)(4)(ii), 14-5A-17(a), 14-5A-09, 14-5A-23(b), 14-5B-09, 14-5B-14(a), 14-5B-19(b), 14-5C-09, 14-5C-17(a), 14-5C-23(b), 14-5D-08, 14-5D-14(a), 14-5D-18(b), 14-5E-09, 14-5E-16(a), 14-5E-23(b), 14-5F-11, 14-5F-18(a), 14-5F-29(b), 15-313, or 15-403, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The final decision in the proceedings in this regulation is made by the full Board.</text> </paragraph> <paragraph num="C."> <text>Denial of Application for Initial License.</text> <paragraph num="(1)"> <text>When an individual files an application for a license with the Board, the applicant shall be investigated to determine whether the Board will:</text> <paragraph num="(a)"> <text>Issue a license; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may vote for the issuance of an intent to deny application for an initial license to practice medicine or an allied health profession for one or any combination of the grounds for denial, including:</text> <paragraph num="(a)"> <text>Failing to meet the minimal qualifications or requirements of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Committing an act or an omission constituting grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Failing to complete the application or failing to provide additional information requested by the Board in connection with the application;</text> </paragraph> <paragraph num="(d)"> <text>Submitting false or misleading information in connection with the application; or</text> </paragraph> <paragraph num="(e)"> <text>Failing to cooperate with the Board’s investigation of the application.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board votes to issue a notice of an intent to deny an application for an initial license, the notice shall be served upon the applicant by regular mail or hand delivery to an address the applicant identified on the applicant’s application.</text> </paragraph> <paragraph num="(4)"> <text>After service of the notice of intent to deny application for initial license, the applicant shall be offered an informal meeting with a panel of the Board to explore whether the matter can be resolved with a consent order. The administrative prosecutor also may attend the meeting. The panel may recommend a consent order granting a license, denying a license, or granting a license with appropriate terms and conditions including probation.</text> </paragraph> <paragraph num="(5)"> <text>If the applicant and the administrative prosecutor agree with the panel’s proposed resolution, the applicant shall sign a consent order with the proposed resolution, and the Board shall vote on whether to approve the resolution. If the applicant and the administrative prosecutor do not agree with the panel’s proposed resolution, the Board shall delegate the matter to the Office of Administrative Hearings for a contested case hearing.</text> </paragraph> <paragraph num="(6)"> <text>If the matter proceeds to a hearing before the Office of Administrative Hearings, the administrative prosecutor shall present evidence before an administrative law judge in support of the denying the initial licensure application. The applicant shall be given an opportunity to present evidence in support of granting the license.</text> </paragraph> <paragraph num="(7)"> <text>The administrative law judge shall conduct an evidentiary hearing in accordance with:</text> <paragraph num="(a)"> <text>The Administrative Procedure Act;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.32.02.04C, which shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The administrative law judge shall issue a proposed decision. Within 15 days of the issuance of the proposed decision, the applicant and the administrative prosecutor may file exceptions to the proposed decision with the Board. A response to the exceptions may be filed within 15 days of the filing of the exceptions.</text> </paragraph> <paragraph num="(9)"> <text>If exceptions are filed, the Board shall hold a hearing on the exceptions. The exceptions hearing is based upon evidentiary record established before the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(10)"> <text>The Board shall vote and issue a final decision and order on whether the initial license application is granted or denied.</text> </paragraph> <paragraph num="(11)"> <text>An individual whose application for initial licensure has been denied by a final decision and order by the Board may petition for judicial review of the final decision and order as provided by Health Occupations Article, §14-408(a), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Unauthorized Practice and Misrepresentation as a Licensed Practitioner.</text> <paragraph num="(1)"> <text>The Board may vote for charges that an individual has practiced medicine or an allied health profession without authorization or that an individual has misrepresented one’s self as a practitioner of medicine or as an allied health professional.</text> </paragraph> <paragraph num="(2)"> <text>If the Board votes to charge an individual for practicing medicine or an allied health care profession without authorization or with misrepresenting one’s self as a practitioner of medicine or as an allied health professional, the notice shall be served upon the respondent by regular mail, certified mail, or hand delivery to the individual.</text> </paragraph> <paragraph num="(3)"> <text>After service of the charges, the respondent shall be offered an informal meeting with a panel of the Board to explore whether the matter can be resolved with a consent order. The administrative prosecutor may attend the meeting. The panel may recommend a consent order.</text> </paragraph> <paragraph num="(4)"> <text>If the respondent and the administrative prosecutor agree with the panel’s proposed resolution, the respondent shall sign a consent order with the proposed resolution, and the Board shall vote on whether to approve the resolution. If the applicant and the administrative prosecutor do not agree with the panel’s proposed resolution, the Board shall delegate the matter to the Office of Administrative Hearings for a contested case hearing.</text> </paragraph> <paragraph num="(5)"> <text>If the matter proceeds to a hearing before the Office of Administrative Hearings, the administrative prosecutor shall present evidence before an administrative law judge to prove the charges. The applicant shall be given an opportunity to present evidence in defense.</text> </paragraph> <paragraph num="(6)"> <text>The administrative law judge shall conduct an evidentiary hearing in accordance with:</text> <paragraph num="(a)"> <text>The Administrative Procedure Act;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.32.02.04C which shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The administrative law judge shall issue a proposed decision. Within 15 days of the issuance of the proposed decision, the applicant and the administrative prosecutor may file exceptions to the proposed decision with the Board. A response to the exceptions may be filed within 15 days of the filing of the exceptions.</text> </paragraph> <paragraph num="(8)"> <text>If exceptions are filed, the Board shall hold a hearing on the exceptions. The exceptions hearing is based upon evidentiary record established before the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(9)"> <text>The Board shall vote and issue a final decision and order. If the Board determines that the respondent has practiced a health care profession without authorization or misrepresented one’s self as a practitioner of medicine, the Board may fine the respondent as authorized by statute and regulation.</text> </paragraph> <paragraph num="(10)"> <text>An individual who is aggrieved by a final decision and order by the Board may petition for judicial review of the final decision and order as provided by Health Occupations Article, §14-408(a), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Cease and Desist Orders</text> <paragraph num="(1)"> <text>An initial Board order to cease and desist issued under §14-206(e) of the Medical Practice Act from the unauthorized practice of medicine or from taking any action for which there are grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland, and which pose a serious risk to the health, safety, and welfare of a patient:</text> <paragraph num="(a)"> <text>Is a public document; and</text> </paragraph> <paragraph num="(b)"> <text>Is effective immediately unless the order states otherwise.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall serve the initial order by hand delivery, certified mail, or first-class mail.</text> </paragraph> <paragraph num="(3)"> <text>Challenge.</text> <paragraph num="(a)"> <text>A respondent may challenge the factual or legal basis of the initial order by filing a written opposition within 30 days of its issuance, and may include a request for a hearing.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall consider that opposition and shall provide a hearing if requested.</text> </paragraph> <paragraph num="(c)"> <text>After considering the written opposition and the presentation at the hearing, if any, the Board may issue a final order to rescind, modify, or affirm the cease and desist order.</text> </paragraph> <paragraph num="(d)"> <text>The Board shall serve the final order by hand delivery, certified mail, or first-class mail to the last known address of the respondent.</text> </paragraph> <paragraph num="(e)"> <text>The respondent may seek judicial review of the Board’s final order as provided in the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Violations of a Cease and Desist Order.</text> <paragraph num="(a)"> <text>The Board may impose a fine as provided in Regulation .09C of this chapter on any individual who violates a cease and desist order.</text> </paragraph> <paragraph num="(b)"> <text>Before imposition of a fine for violation of a cease and desist order, the Board shall give notice of the alleged violation, and an opportunity for a hearing.</text> </paragraph> <paragraph num="(c)"> <text>The hearing may not concern issues:</text> <paragraph num="(i)"> <text>That were not raised under §E(3) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>That were raised under §E(3) of this regulation, but for which the Board did not grant the relief or modification requested.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The only issues to be considered at the hearing are:</text> <paragraph num="(i)"> <text>Whether the individual violated the cease and desist order; and</text> </paragraph> <paragraph num="(ii)"> <text>The amount of any fine to be imposed.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The Board shall issue a final order stating whether a violation occurred and if so, the amount of the fine.</text> </paragraph> <paragraph num="(f)"> <text>The respondent may seek judicial review of the Board’s final order as provided in the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Nothing in this regulation prohibits the Board from delegating any hearing to the Office of Administrative Hearings as permitted by State Government Article, §10-205, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Judicial Review."> <paragraph num="A."> <text>A respondent whose license has been sanctioned by a final order of the disciplinary panel after a contested case proceeding under Health Occupations Article, §14-404, 14-5A-17.1, 14-5B-14.1, 14-5C-17(b), 14-5D-15, 14-5E-17, 14-5F-23, or 15-315(b), Annotated Code of Maryland, may seek judicial review of the disciplinary panel’s decision as provided under Health Occupations Article, §14-408(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An individual whose application for administrative reinstatement has been denied by a final disciplinary panel order after a contested case proceeding under Health Occupations Article, §14-205(a)(1)(iii), 14-5A-17.1, 14-5B-14.1, 14-5C-17(b), 14-5D-15, 14-5E-17, 14-5F-23, or 15-315(b), Annotated Code of Maryland, may appeal the decision as provided under Health Occupations Article, §14-408(a), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Recusal in Board or Disciplinary Panel Proceedings."> <paragraph num="A."> <text>A Board or disciplinary panel member may not participate in an investigation or a proceeding in which the impartiality of the Board or disciplinary panel member might reasonably be questioned, including but not limited to proceedings and investigations in which the Board or disciplinary panel member has or appears to have:</text> <paragraph num="(1)"> <text>A personal bias or prejudice concerning a party; or</text> </paragraph> <paragraph num="(2)"> <text>Personal knowledge of disputed evidentiary facts concerning a proceeding.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The recusal shall be stated on the record.</text> </paragraph> <paragraph num="C."> <text>In a hearing before the Board or disciplinary panel, the parties may waive the recusal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Proposed Orders; Show Cause Hearings."> <paragraph num="A."> <text>Nothing in this chapter prohibits the issuance of a charging document with a proposed order which will go into effect if the respondent fails to request a hearing.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter prohibits a disciplinary panel from conducting a show cause hearing to determine if there has been:</text> <paragraph num="(1)"> <text>A violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>A violation of a condition under which any portion of a disciplinary order was stayed; or</text> </paragraph> <paragraph num="(3)"> <text>Any other violation of a Board or disciplinary panel order.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A disciplinary panel may terminate a show cause hearing if it determines that there are material facts in dispute which cannot reasonably be determined in that venue. The disciplinary panel may then convene an evidentiary hearing or delegate such a hearing to an administrative law judge.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Confidentiality."> <paragraph num="A."> <text>Except for formal charging documents, notices of intent to deny, or as otherwise provided by law, the proceedings of the Board and the disciplinary panels are confidential, and the confidentiality of the proceedings cannot be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>The recommended decision by an administrative law judge is confidential, and the respondent cannot waive the confidentiality of the contested case proceedings or of the patients whose care is reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is entered by the Board or a disciplinary panel, the parties shall refrain from revealing legal documents or oral statements or information that would reveal the identity of any patients referenced in the order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Ethics."> <text>The Board and the disciplinary panels may consider the Principles of Ethics of the American Medical Association, but these principles are not binding on the Board or the disciplinary panels.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Opioid Guidelines."> <text>The Board and the disciplinary panels may consider the “Guideline for Prescribing Opioids for Chronic Pain” published by the Centers for Disease Control and Prevention, but this guideline is not binding on the Board or the disciplinary panels.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Administrative Expungement."> <paragraph num="A."> <text>Administrative Expungements.</text> <paragraph num="(1)"> <text>The Applicant may file with the Board an application for administrative expungement to have records of an administrative action by a disciplinary panel classified as confidential, not for public release, and removed from the licensee’s public individual profile, if:</text> <paragraph num="(a)"> <text>The application is submitted more than 3 years after the imposition of an administrative action by the Board or after administrative reinstatement or termination of suspension of the license, whichever is later;</text> </paragraph> <paragraph num="(b)"> <text>The licensee had no incidents of a public sanction since the administrative action identified in the application occurred; and</text> </paragraph> <paragraph num="(c)"> <text>The licensee is not currently under probation or investigation by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An application for administrative expungement shall only be granted for the following administrative actions:</text> <paragraph num="(a)"> <text>Failure to pay taxes or unemployment insurance contributions under Health Occupations Article, §1-213(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Failure to complete continuing medical education requirements under Health Occupations Article, §14-316(d), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Failure to renew a license on time under Health Occupations Article, §14-606(a)(5), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>Failure to notify the Board in writing of change of name or address within the time required under Health Occupations Article, §14-316(f).</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An administrative expungement shall not be considered for any license denials, reprimands, probations, suspensions, and revocations issued pursuant to Health Occupations Article, §14-404, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application for Administrative Expungement.</text> <paragraph num="(1)"> <text>The application for administrative expungement shall be filed in writing on a form provided by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The application fee shall be $450.</text> </paragraph> <paragraph num="(3)"> <text>The application fee is non-refundable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Disposition of Application.</text> <paragraph num="(1)"> <text>If the applicant meets the requirements specified in §§A and B of this regulation, the Board shall inform the applicant when to expect the records to be removed from the applicant’s public practitioner profile as required in Health Occupations Article, §14-411.1, Annotated Code of Maryland, and when all Board records will be classified confidential.</text> </paragraph> <paragraph num="(2)"> <text>If the applicant does not meet the requirements specified in §§A and B of this regulation, the applicant will be deemed ineligible and the Board shall notify the applicant in writing.</text> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is ineligible under §C(2) of this regulation may reapply when they meet the criteria.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board is not required to report an administrative expungement to any national database.</text> </paragraph> <paragraph num="E."> <text>Nothing in this regulation shall prohibit the Board from using a Board record, previous sanction, or disciplinary action for any regulatory purpose or from releasing records to law enforcement or other governmental body as permitted by law.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-307, 1-402, 1-602—1-604, 1-606, 14-205, 14-317, 14-404, 14-405, 14-405.1, 14-406—14-409, 14-411, 14-505, 14-5A-03, 14-5A-13(d), 14-5A-16, 14-5A-17, 14-5A-17.1, 14-5A-19, 14-5B-03, 14-5B-12(d), 14-5B-13, 14-5B-14, 14-5B-14.1, 14-5B-16, 14-5C-03, 14-5C-14(h), 14-5C-16, 14-5C-17, 14-5C-19, 14-5D-12(d), 14-5D-12(g), 14-5D-13—14-5D-16, 14-5E-03, 14-5E-13(h), 14-5E-15, 14-5E-16, 14-5E-17, 14-5E-19, 14-5F-04, 14-5F-15(e), 14-5F-17, 14-5F-18, 14-5F-23, 14-5F-24, 14-601, 14-606, 15-205(b), 15-307(f), 15-311, 15-312, 15-314, 15-315, 15-316 and 15-403; State Government Article, §§10-206, 10-216, and 10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 30, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10, Hearing Procedures, repealed effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09, Hearing Before the Board of Physician Quality Assurance, adopted effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective March 22, 1999 (26:6 Md. R. 486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective January 24, 2000 (27:1 Md. R. 76); June 24, 2002 (29:12 Md. R. 927)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 21, 2013 (40:1 Md. R. 20)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 2, 2015 (42:4 Md. R. 433)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 17, 2025 (52:5 Md. R. 237)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective August 7, 2023 (50:15 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective August 7, 2023 (50:15 Md. R. 682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective October 23, 2017 (44:21 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted effective March 17, 2025 (52:5 Md. R. 237)</annotation> </annotations> </chapter> <chapter num="03" heading="Physician Assistant"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of physician assistants and collaboration between physician assistants and one or more patient care team physicians.</text> </paragraph> <paragraph num="B."> <text>This chapter does not prohibit:</text> <paragraph num="(1)"> <text>A student from performing any of the procedures described in these regulations as part of an accredited school's clinical curriculum;</text> </paragraph> <paragraph num="(2)"> <text>An individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>A physician assistant employed by the federal government from performing duties incident to that employment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited” means accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor.</text> </paragraph> <paragraph num="(2)"> <text>“Advanced duties” means medical acts that require additional education, training, or experience that is beyond the physician assistant education program required for licensure.</text> </paragraph> <paragraph num="(3)"> <text>“Ambulatory surgical facility” means a facility:</text> <paragraph num="(a)"> <text>Accredited by:</text> <paragraph num="(i)"> <text>The American Association for Accreditation of Ambulatory Surgical Facilities;</text> </paragraph> <paragraph num="(ii)"> <text>The Accreditation Association for Ambulatory Health Care; or</text> </paragraph> <paragraph num="(iii)"> <text>The Joint Commission on the Accreditation of Health Care Organizations; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Certified to participate in the Medicare Program, as enacted by Title XVIII of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Applicant” means an individual who applies to the State Board of Physicians for licensure as a physician assistant.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(6)"> <text>“Category I hours” means hours of continuing medical education given in formally organized programs pertinent to the practice of physician assistant duties, accredited by the American Academy of Physician Assistants, the American Academy of Family Physicians, the Accreditation Council on Continuing Medical Education, the Medical and Chirurgical Faculty of Maryland, or equivalent certifying bodies.</text> </paragraph> <paragraph num="(7)"> <text>“Collaborating physician” means one or more patient care team physicians who collaborate with a physician assistant under a collaboration agreement.</text> </paragraph> <paragraph num="(8)"> <text>Collaboration.</text> <paragraph num="(a)"> <text>“Collaboration” means the communication and decision-making process among health care providers who are members of a patient care team related to the treatment of a patient which includes the degree of cooperation necessary to provide treatment and care to the patient.</text> </paragraph> <paragraph num="(b)"> <text>“Collaboration” includes:</text> <paragraph num="(i)"> <text>Communication of data and information about the treatment and care of a patient, including the exchange of clinical observations and assessments; and</text> </paragraph> <paragraph num="(ii)"> <text>The development of an appropriate plan of care including decisions regarding the health care provided, accessing and assessing appropriate additional resources, expertise, referrals, testing, or studies.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Collaboration” does not require constant, physical presence of a collaborating physician on-site in the practice setting provided that the collaborating physician is accessible by electronic means.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Collaboration agreement” means a document that outlines the relationship between a physician assistant and an individual physician or a group of physicians which is maintained at the practice level and is developed between a physician assistant and collaborating physician or physicians.</text> </paragraph> <paragraph num="(10)"> <text>“Committee” means the Physician Assistant Advisory Committee.</text> </paragraph> <paragraph num="(11)"> <text>“Controlled dangerous substances” means any drug listed as such in Criminal Law Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Core duties” means medical acts that are included in the standard curricula of accredited physician assistant education programs.</text> </paragraph> <paragraph num="(13)"> <text>“Correctional facility” means a State or local correctional facility.</text> </paragraph> <paragraph num="(14)"> <text>“Detention center” means a State or local detention center.</text> </paragraph> <paragraph num="(15)"> <text>“Drug sample” means a unit of a prescription drug that is intended to promote the sale of the drug and is not intended for sale.</text> </paragraph> <paragraph num="(16)"> <text>“English-speaking professional school” means a school:</text> <paragraph num="(a)"> <text>That offers a degree after graduation from high school;</text> </paragraph> <paragraph num="(b)"> <text>That is in the United States, its territories and possessions, or the British Commonwealth; and</text> </paragraph> <paragraph num="(c)"> <text>Where all academic and clinical courses are taught in English.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Exempt facility” means:</text> <paragraph num="(a)"> <text>A hospital;</text> </paragraph> <paragraph num="(b)"> <text>An ambulatory surgical facility;</text> </paragraph> <paragraph num="(c)"> <text>A federally qualified health center as defined in Health-General Article, §24-1301(b), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(d)"> <text>Any other practice setting listed on a hospital delineation of privileges document.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Hospital” means:</text> <paragraph num="(a)"> <text>A hospital as defined under Health-General Article, §19-301(g), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A comprehensive care facility that:</text> <paragraph num="(i)"> <text>Meets the requirements of a hospital-based skilled nursing facility under 42 U.S.C. §1395i-3; and</text> </paragraph> <paragraph num="(ii)"> <text>Offers acute care in the same building; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>An emergency room that is physically connected to a hospital or a freestanding medical facility that is licensed under Health-General Article, Title 19, Subtitle 3A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Joint Commission” means the organization formerly known as the Joint Commission on Accreditation of Health Care Organizations.</text> </paragraph> <paragraph num="(20)"> <text>“NCCPA” means the National Commission on Certification of Physician Assistants, Inc.</text> </paragraph> <paragraph num="(21)"> <text>“On-site” means the physical presence of the collaborating physician on the premises of the facility where the physician assistant performs delegated medical acts.</text> </paragraph> <paragraph num="(22)"> <text>“Patient care team” means a multidisciplinary team of health care providers actively functioning as a unit with the leadership of one or more patient care team physicians for the purpose of providing and delivering health care to a patient or group of patients.</text> </paragraph> <paragraph num="(23)"> <text>“Patient care team physician” means a licensed physician who regularly practices in the State and who provides leadership in the care of patients as part of a patient care team.</text> </paragraph> <paragraph num="(24)"> <text>“Physician” means an individual who is licensed by the Board to practice medicine.</text> </paragraph> <paragraph num="(25)"> <text>“Physician assistant” means an individual who is licensed by the Board to practice as a physician assistant.</text> </paragraph> <paragraph num="(26)"> <text>“Prescriptive authority” means the authority of a physician assistant to:</text> <paragraph num="(a)"> <text>Prescribe and administer:</text> <paragraph num="(i)"> <text>Controlled dangerous substances;</text> </paragraph> <paragraph num="(ii)"> <text>Prescription drugs; and</text> </paragraph> <paragraph num="(iii)"> <text>Medical devices;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Give verbal, written, or electronic orders for medications; and</text> </paragraph> <paragraph num="(c)"> <text>Dispense starter dosages or drug samples.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Public health facility” means a site where clinical public health services are rendered under the auspices of the Department, a local health department in a county, or the Baltimore City Health Department.</text> </paragraph> <paragraph num="(28)"> <text>“Starter dosage” means an amount of a drug sufficient to begin therapy:</text> <paragraph num="(a)"> <text>Of short duration of 72 hours or less; or</text> </paragraph> <paragraph num="(b)"> <text>Before obtaining a larger quantity of the drug to complete therapy.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Training” means the education or on-the-job training a physician assistant:</text> <paragraph num="(a)"> <text>Receives after initial licensure as a physician assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Requires to perform advanced duties.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Physician Assistant Advisory Committee."> <paragraph num="A."> <text>Composition. The Physician Assistant Advisory Committee shall be composed as required under Health Occupations Article, §15-202, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The initial terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second term but an individual may not serve more than two consecutive terms.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Vacancy. If a vacancy occurs for a physician or physician assistant, the Board shall appoint a new member in the same category.</text> </paragraph> <paragraph num="D."> <text>Officers. A Committee chairperson shall be elected every 2 years by a majority vote of the membership of the Committee.</text> </paragraph> <paragraph num="E."> <text>Removal. Upon the recommendation of the chairman, the Board, by a majority, may vote to remove any member of the Committee for:</text> <paragraph num="(1)"> <text>Neglect of duty, including but not limited to:</text> <paragraph num="(a)"> <text>Failure to attend two successive committee meetings without adequate reason;</text> </paragraph> <paragraph num="(b)"> <text>Failure to attend Board mandated training; or</text> </paragraph> <paragraph num="(c)"> <text>Failure to complete necessary ethics filing requirements;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Malfeasance;</text> </paragraph> <paragraph num="(3)"> <text>Misfeasance;</text> </paragraph> <paragraph num="(4)"> <text>Misconduct; or</text> </paragraph> <paragraph num="(5)"> <text>Incompetency.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Upon request, review selected applications for licensure, renewal, or reinstatement of physician assistants and make recommendations to the Board as to what action to take on the applications;</text> </paragraph> <paragraph num="(2)"> <text>Review each advanced duty which requires prior approval by the Board and, as needed, interview each physician assistant and one or more patient care team physicians to make recommendations to the Board;</text> </paragraph> <paragraph num="(3)"> <text>Make recommendations to the Board regarding regulations governing physician assistants; and</text> </paragraph> <paragraph num="(4)"> <text>Advise the Board on matters related to the practice of physician assistants.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Committee may delegate a physician member and a physician assistant member of the Committee to conduct the interview of each physician assistant and patient care team physician, as permitted under §F(2) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Practice."> <paragraph num="A."> <text>Except as otherwise provided under Health Occupations Article, Title 15, Annotated Code of Maryland, an individual shall be licensed by the Board and notify the Board of an executed collaboration agreement before the individual may practice as a physician assistant or collaborate with a patient care team physician.</text> </paragraph> <paragraph num="B."> <text>A physician assistant's scope of practice will be limited to medical acts that are:</text> <paragraph num="(1)"> <text>Appropriate to the education, training, and experience of the physician assistant;</text> </paragraph> <paragraph num="(2)"> <text>Customary to the practice of a patient care team physician; and</text> </paragraph> <paragraph num="(3)"> <text>Performed in a manner consistent with the collaboration agreement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A physician assistant may delegate technical medical acts authorized under Health Occupations Article, §14-306, Annotated Code of Maryland and COMAR 10.32.12 provided the physician assistant:</text> <paragraph num="(1)"> <text>Has notified the Board, in a manner approved by the Board of an executed collaboration agreement; and</text> </paragraph> <paragraph num="(2)"> <text>Has completed at least 7,000 hours of clinical practice experience.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prohibitions.</text> <paragraph num="(1)"> <text>Regardless of the setting or other factors, a patient care team physician may not delegate, and a physician assistant may not perform general anesthesia or neuraxial anesthesia, including spinal, epidural, and image-guided interventional spine procedures.</text> </paragraph> <paragraph num="(2)"> <text>Except in hospitals, detention centers, correctional facilities, and public health facilities, a patient care team physician may not collaborate with more than eight physician assistants during the same shift.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications for Licensure as a Physician Assistant."> <paragraph num="A."> <text>Application. Applicants shall:</text> <paragraph num="(1)"> <text>Complete an application on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay an application fee as defined in Regulation .16 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be at least 18 years old;</text> </paragraph> <paragraph num="(4)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(5)"> <text>Demonstrate oral and written competency in English by one or more of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school; or</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the Speaking Section of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Education.</text> <paragraph num="(1)"> <text>An applicant who has successfully completed an educational program for physician assistants shall:</text> <paragraph num="(a)"> <text>Have graduated from a physician assistant program accredited by The Accreditation Review Commission on Education for the Physician Assistant (ARC-PA), its predecessor, or its successor; and</text> </paragraph> <paragraph num="(b)"> <text>Have passed the physician assistant national certifying examination administered by the National Commission on Certification of Physician Assistants (NCCPA) or its successor.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to the requirement specified in §B(1) of this regulation, an applicant who has successfully completed an educational program for physician assistants after October 1st, 2003, shall have one of the following:</text> <paragraph num="(a)"> <text>A bachelor’s degree; or</text> </paragraph> <paragraph num="(b)"> <text>At least 120 credit hours of education at the college or university level.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Primary Source Verification. The Board may accept the Federation Credential Verification Service for primary source verification of a physician assistant's education and examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Collaboration Agreements—Core Duties."> <paragraph num="A."> <text>Before a physician assistant may perform medical acts, the physician assistant shall:</text> <paragraph num="(1)"> <text>Execute a collaboration agreement between the physician assistant and one or more patient care team physicians;</text> </paragraph> <paragraph num="(2)"> <text>Notify the Board in a manner approved by the Board of the executed collaboration agreement; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain a copy of the executed collaboration agreement on file at the physician assistant’s primary practice location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Collaboration Agreement Requirements.</text> <paragraph num="(1)"> <text>A collaboration agreement may only consist of one physician assistant and one or more patient care team physicians practicing at the same facility.</text> </paragraph> <paragraph num="(2)"> <text>A physician assistant shall have a separate collaboration agreement for each of the physician assistant’s employers.</text> </paragraph> <paragraph num="(3)"> <text>The physician assistant has the affirmative obligation to retain the collaboration agreement and all of the documentation pertaining to the collaboration agreement for 5 years after termination of the collaboration agreement for Board inspection.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Contents.</text> <paragraph num="(1)"> <text>The collaboration agreement shall include, at minimum:</text> <paragraph num="(a)"> <text>Each patient care team physician’s name and Maryland license number;</text> </paragraph> <paragraph num="(b)"> <text>A description of each patient care team physician’s qualifications to collaborate with a physician assistant;</text> </paragraph> <paragraph num="(c)"> <text>The practice specialty of each listed patient care team physician;</text> </paragraph> <paragraph num="(d)"> <text>The physician assistant’s name and Maryland license number;</text> </paragraph> <paragraph num="(e)"> <text>The primary location and settings where the physician assistant will practice;</text> </paragraph> <paragraph num="(f)"> <text>The employer of the physician assistant;</text> </paragraph> <paragraph num="(g)"> <text>A description of the settings where the physician assistant will practice;</text> </paragraph> <paragraph num="(h)"> <text>Any delegation of prescriptive authority and, if applicable, dispensing according to Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(i)"> <text>Any other information deemed necessary by the Board to carry out the provisions of Health Occupations Article, Title 15, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The collaboration agreement may include a description of any provisions established by the listed patient care team physicians that:</text> <paragraph num="(a)"> <text>Detail the practice of the physician assistant;</text> </paragraph> <paragraph num="(b)"> <text>Limit the physician assistant's scope of practice; or</text> </paragraph> <paragraph num="(c)"> <text>Specify office procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The physician assistant shall attest that:</text> <paragraph num="(1)"> <text>All medical acts performed by the physician assistant shall be:</text> <paragraph num="(a)"> <text>Appropriate to the education, training, and experience of the physician assistant;</text> </paragraph> <paragraph num="(b)"> <text>Customary to the practice of a patient care team physician listed on the collaboration agreement; and</text> </paragraph> <paragraph num="(c)"> <text>Performed in a manner consistent with the collaboration agreement; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any performance of an advanced duty in collaboration with a patient care team physician shall be in accordance with Health Occupations Article, §15-302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Each collaborating physician shall document their official acknowledgment of their understanding and status as a listed patient care team physician on the collaboration agreement with the physician assistant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Collaboration Agreements—Advanced Duties."> <paragraph num="A."> <text>A physician assistant that has sufficient education, training, and experience in the performance of an advanced duty, may perform that advanced duty under a collaboration agreement without Board approval if:</text> <paragraph num="(1)"> <text>The physician assistant is practicing at an exempt facility in accordance with Health Occupations Article, §15–302.1, Annotated Code of Maryland and meets the conditions in §A(4) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The physician assistant has previously received Board approval to perform the advanced duty; or</text> </paragraph> <paragraph num="(3)"> <text>The physician assistant has at least 7,000 hours of clinical practice experience as attested to by the physician assistant.</text> </paragraph> <paragraph num="(4)"> <text>For a physician assistant practicing at an exempt facility the following shall be met:</text> <paragraph num="(a)"> <text>The patient care team physician listed on the collaboration agreement has been credentialed by the exempt facility as a condition of employment;</text> </paragraph> <paragraph num="(b)"> <text>The physician assistant listed on the collaboration agreement has been credentialed by the exempt facility as a condition of employment; and</text> </paragraph> <paragraph num="(c)"> <text>The advanced duty to be delegated by the patient care team physician to the physician assistant is reviewed and approved in a process approved by the exempt facility before the physician assistant performs the advanced duty.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except as provided under §A of this regulation, a physician assistant shall receive Board approval to perform an advanced duty prior to performing the advanced duty.</text> </paragraph> <paragraph num="C."> <text>A physician assistant performing X-Ray duties in accordance with Health Occupations Article, §14–306(e), Annotated Code of Maryland, shall:</text> <paragraph num="(1)"> <text>Notify the Board of an executed collaboration agreement in a manner approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Maintain a copy of the collaboration agreement on file at the practice location;</text> </paragraph> <paragraph num="(3)"> <text>Obtain Board approval for the X-Ray duty as an advanced duty if practicing at a location other than an exempt facility;</text> </paragraph> <paragraph num="(4)"> <text>Perform the X-Ray duty in the medical office of a patient care team physician; and</text> </paragraph> <paragraph num="(5)"> <text>Be limited to nonfluoroscopic X-Ray procedures of the extremities, anterior-posterior and lateral, not including the head.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of §C of this regulation, a physician assistant performing the advanced duty of nonfluoroscopic X-ray procedures using a mini C-arm or similar low-level radiation machine shall be required to present the Board with evidence of completion of a course that includes:</text> <paragraph num="(1)"> <text>Didactic instruction of at least eight hours on the following subject matters:</text> <paragraph num="(a)"> <text>Principles of radiography;</text> </paragraph> <paragraph num="(b)"> <text>Image acquisition;</text> </paragraph> <paragraph num="(c)"> <text>Principles of exposure;</text> </paragraph> <paragraph num="(d)"> <text>Image evaluation;</text> </paragraph> <paragraph num="(e)"> <text>Radiation safety;</text> </paragraph> <paragraph num="(f)"> <text>Equipment overview; and</text> </paragraph> <paragraph num="(g)"> <text>Documentation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Clinical instruction, which shall:</text> <paragraph num="(a)"> <text>Include anterior-posterior and lateral radiographic studies of extremities, not including the head, on at least 20 separate patients; and</text> </paragraph> <paragraph num="(b)"> <text>Be under the direct supervision of the delegating physician or radiologist.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Approval, Disapproval, Ineligible, or Modification of Advanced Duties."> <paragraph num="A."> <text>Approvals of Advanced Duties.</text> <paragraph num="(1)"> <text>Documentation demonstrating a physician assistant’s authority to perform an advanced duty under this section shall be maintained at the facility where the physician assistant is performing the advanced duty.</text> </paragraph> <paragraph num="(2)"> <text>The Board may audit and review collaboration agreements kept by the physician assistant at the primary place of business of the licensee at any time.</text> </paragraph> <paragraph num="(3)"> <text>If an advanced duty requires Board approval, the Committee:</text> <paragraph num="(a)"> <text>Shall review the collaboration agreement;</text> </paragraph> <paragraph num="(b)"> <text>May conduct a personal interview of the physician assistant and patient care team physicians; or</text> </paragraph> <paragraph num="(c)"> <text>May recommend to the Board that the collaboration agreement be modified to ensure conformance with the requirements of Health Occupations Article, §§15–302 and 15–302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Modification or Disapproval of Advanced Duties.</text> <paragraph num="(1)"> <text>The Board may modify or disapprove the performance of advanced duties under a collaboration agreement if the physician assistant does not meet the applicable education, training, and experience requirements to perform the specified advanced duties.</text> </paragraph> <paragraph num="(2)"> <text>If the Board disapproves or modifies a request to perform an advanced duties, the Board shall:</text> <paragraph num="(a)"> <text>Notify the delegating patient care team physician listed in the collaboration agreement and the physician assistant in writing of the particular elements of the advanced duty approval request that were the cause for the modification or denial;</text> </paragraph> <paragraph num="(b)"> <text>Set forth the specific reasons for the modification or denial; and</text> </paragraph> <paragraph num="(c)"> <text>Give the applicant an opportunity to submit an amendment to the advanced duty or request a hearing before the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To request a hearing regarding modification or disapproval of advanced duties, the applicant shall make a written request for a hearing within 30 days of the receipt of the notice of modification or disapproval.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Physician Assistant Deemed Ineligible to Perform an Advanced Duty.</text> <paragraph num="(1)"> <text>A physician assistant who applies to perform an advanced duty may be deemed ineligible to perform an advanced duty if the physician assistant or patient care team physician:</text> <paragraph num="(a)"> <text>Fails to complete the application;</text> </paragraph> <paragraph num="(b)"> <text>Fails to provide additional information requested by the Board in connection with the application; or</text> </paragraph> <paragraph num="(c)"> <text>Submits false or misleading information to the Board in connection with the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a physician assistant is deemed ineligible to perform the advanced duty, the Board shall:</text> <paragraph num="(a)"> <text>Give written notice to the applicant; and</text> </paragraph> <paragraph num="(b)"> <text>Set forth the specific reasons for the ineligibility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A physician assistant who is deemed ineligible to perform the advanced duty shall not be authorized to perform the advanced duty except for training purposes under the direct supervision of a patient care team physician listed on the collaboration agreement.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Individual members of the Board are not civilly liable for actions regarding the approval, modification, or disapproval of an advanced duty under the collaboration agreement described in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Prescriptive Authority and Dispensing Starter Dosage or Drug Samples."> <paragraph num="A."> <text>In order for a patient care team physician to delegate prescriptive authority, the [primary supervising] patient care team physician shall ensure that the collaboration agreement includes:</text> <paragraph num="(1)"> <text>A statement describing whether the physician intends to delegate any of the following:</text> <paragraph num="(a)"> <text>Prescribing of:</text> <paragraph num="(i)"> <text>Controlled dangerous substances;</text> </paragraph> <paragraph num="(ii)"> <text>Prescription drugs; or</text> </paragraph> <paragraph num="(iii)"> <text>Medical devices;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Giving verbal, written, or electronic orders for medications;</text> </paragraph> <paragraph num="(c)"> <text>Dispensing starter dosages or drug samples;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An attestation that all prescribing activities of the physician assistant will comply with applicable federal and State regulations;</text> </paragraph> <paragraph num="(3)"> <text>An attestation that all medical charts and records will contain a notation of any prescriptions written by a physician assistant;</text> </paragraph> <paragraph num="(4)"> <text>An attestation that all prescriptions dispensed include the physician assistant's name and the patient care team physician’s name, business address, and business telephone number legibly written or printed;</text> </paragraph> <paragraph num="(5)"> <text>An attestation that the physician assistant has:</text> <paragraph num="(a)"> <text>Passed the physician assistant national certification exam administered by the National Commission on the Certification of Physician Assistants, Inc. within the previous 2 years; or</text> </paragraph> <paragraph num="(b)"> <text>Completed 8 Category I hours of pharmacology education within the previous 2 years; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An attestation that the physician assistant has at least one of the following:</text> <paragraph num="(a)"> <text>A bachelor's degree or its equivalent; or</text> </paragraph> <paragraph num="(b)"> <text>2 years of work experience as a physician assistant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dispensing of Drug Samples and Starter Dosages of Drugs by Physician Assistant.</text> <paragraph num="(1)"> <text>A drug sample or starter dosage shall meet the following criteria before a physician assistant may dispense the drug sample or starter dosage:</text> <paragraph num="(a)"> <text>Package is labeled as required by Health Occupations Article, §12-505, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>No charge is made for the drug sample or starter dosage.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A physician assistant shall enter an appropriate note in the patient’s medical record.</text> </paragraph> <paragraph num="(3)"> <text>A physician assistant may not delegate dispensing of drug samples or starter dosages.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewal, Reinstatement, Change in Name or Address, and Continuing Education."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has been licensed by the Board as a physician assistant may renew the license every 2 years on the date specified by the Board by:</text> <paragraph num="(a)"> <text>Completing an application on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee as defined in Regulation .16 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to completion of continuing education activities as specified in §D of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>Meeting any additional requirements set by the Board for renewal of a license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement. The Board shall reinstate the license of a physician assistant if the physician assistant:</text> <paragraph num="(1)"> <text>Completes an application on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays the required reinstatement fee as defined in Regulation .16 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Submits evidence of completion of continuing education activities as specified in §D of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Meets any additional requirements set by the Board for reinstatement of a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Change in Name or Address.</text> <paragraph num="(1)"> <text>A physician assistant shall notify the Board in writing of a change in the physician assistant's name or address within 60 days after the change.</text> </paragraph> <paragraph num="(2)"> <text>If a physician assistant fails to notify the Board within the time required under §C(1) of this regulation, the physician assistant is subject to an administrative penalty of $100.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>Except as specified in §D(2) of this regulation, in order to renew or reinstate a license under §A or B of this regulation, a physician assistant shall complete at least 50 hours of continuing education consisting of:</text> <paragraph num="(a)"> <text>At least 8 hours of Category 1 education on pharmacology topics earned during the 2-year period preceding:</text> <paragraph num="(i)"> <text>For license renewal, the expiration of the physician assistant license; or</text> </paragraph> <paragraph num="(ii)"> <text>For license reinstatement, the date of the submission of the application for reinstatement; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In addition to the continuing education hours specified in §D(1)(a) of this regulation, at least 42 hours of Category I continuing education earned during the 2-year period preceding:</text> <paragraph num="(i)"> <text>For license renewal, the expiration of the physician assistant license; or</text> </paragraph> <paragraph num="(ii)"> <text>For license reinstatement, the date of the submission of the application for reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A physician assistant who is renewing a license as a physician assistant for the first time since either initial licensure or reinstatement of a license:</text> <paragraph num="(a)"> <text>Shall earn at least 8 hours of Category 1 education on pharmacology topics prior to the expiration of the physician assistant license; and</text> </paragraph> <paragraph num="(b)"> <text>Is not required to complete any other hours of Category I continuing education prior to the expiration of the physician assistant license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation of Continuing Education.</text> <paragraph num="(a)"> <text>A physician assistant shall obtain documentation of attendance at Category I continuing education and retain the documentation for 6 years.</text> </paragraph> <paragraph num="(b)"> <text>The documentation shall contain, at a minimum, the following information:</text> <paragraph num="(i)"> <text>Program title;</text> </paragraph> <paragraph num="(ii)"> <text>Sponsor’s name;</text> </paragraph> <paragraph num="(iii)"> <text>Physician assistant’s name;</text> </paragraph> <paragraph num="(iv)"> <text>Inclusive date or dates and location of the program;</text> </paragraph> <paragraph num="(v)"> <text>Category I designation and the number of continuing education hours earned; and</text> </paragraph> <paragraph num="(vi)"> <text>Documented verification that the physician assistant attended the program by stamp, signature, printout, or other official proof.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Proof of maintenance of certification by the National Commission on Certification of Physician Assistants may be used to document compliance with the continuing education requirement.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may request a physician assistant to submit evidence of having met the continuing education requirements specified in this regulation.</text> </paragraph> <paragraph num="(5)"> <text>If a physician assistant cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education credit hour.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Identification as Physician Assistant."> <paragraph num="A."> <text>A physician assistant shall:</text> <paragraph num="(1)"> <text>Wear an identification tag or badge which identifies that individual as a physician assistant;</text> </paragraph> <paragraph num="(2)"> <text>Identify himself or herself to all patients as a physician assistant; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain a copy of the physician assistant’s license and collaboration agreement at the practice setting.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual may not identify himself or herself as a physician assistant unless licensed by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Responsibility of the Physician Assistant."> <paragraph num="A."> <text>A physician assistant shall:</text> <paragraph num="(1)"> <text>Notify the Board in a manner approved by the Board of an executed collaboration agreement developed by the listed patient care team physician or physicians and the physician assistant;</text> </paragraph> <paragraph num="(2)"> <text>Collaborate with a patient care team physician for medical acts that:</text> <paragraph num="(a)"> <text>Are customary to the practice of a listed patient care team physician; and</text> </paragraph> <paragraph num="(b)"> <text>Are suitable to be performed by the physician assistant, taking into account the physician assistant’s:</text> <paragraph num="(i)"> <text>Education;</text> </paragraph> <paragraph num="(ii)"> <text>Training; and</text> </paragraph> <paragraph num="(iii)"> <text>Experience;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain approval for any advanced duties; and;</text> </paragraph> <paragraph num="(4)"> <text>Update the practitioner profile to report the termination of a collaboration agreement for any reason to the Board within 5 days, providing the following information:</text> <paragraph num="(a)"> <text>Name and license number of the patient care team physician and physician assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Reason for termination, including a description of conduct or incident that resulted in the termination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Sudden Departure of the Patient Care Team Physician.</text> <paragraph num="(1)"> <text>In the event of the sudden departure, incapacity, or death of a patient care team physician, or in a change in licensure status that results in a patient care team physician being unable to practice medicine in the State, the collaboration agreement will remain active and valid under the supervision of any remaining listed patient care team physicians.</text> </paragraph> <paragraph num="(2)"> <text>If no remaining patient care team physicians are listed on the collaboration agreement, the physician assistant may not practice until the physician assistant has executed a new collaboration agreement and provided notification to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Prohibited Conduct."> <paragraph num="A."> <text>The Board may deny a license, reprimand a physician assistant, place a physician assistant on probation, or suspend or revoke a license if the physician assistant:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or the licensee or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of:</text> <paragraph num="(a)"> <text>Immoral conduct in the practice of medicine; or</text> </paragraph> <paragraph num="(b)"> <text>Unprofessional conduct in the practice of medicine;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Solicits or advertises in violation of Health Occupations Article, §14-503, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(7)"> <text>Is habitually intoxicated;</text> </paragraph> <paragraph num="(8)"> <text>Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Provides professional services:</text> <paragraph num="(a)"> <text>While under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>While using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Promotes the sale of drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(11)"> <text>Willfully makes or files a false report or record in the practice of medicine;</text> </paragraph> <paragraph num="(12)"> <text>Willfully fails to file or record any medical report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="(13)"> <text>On proper request, and in accordance with the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, fails to provide details of a patient's medical record to the patient, another physician, or hospital;</text> </paragraph> <paragraph num="(14)"> <text>Solicits professional patronage through an agent or other person or profits from the acts of a person who is represented as an agent of the physician assistant;</text> </paragraph> <paragraph num="(15)"> <text>Pays or agrees to pay any sum to any person for bringing or referring a patient or accepts or agrees to accept any sum from any person for bringing or referring a patient;</text> </paragraph> <paragraph num="(16)"> <text>Agrees with a clinical or bioanalytical laboratory to make payments to the laboratory for a test or test series for a patient, unless the licensed physician assistant discloses on the bill to the patient or third-party payor:</text> <paragraph num="(a)"> <text>The name of the laboratory;</text> </paragraph> <paragraph num="(b)"> <text>The amount paid to the laboratory for the test or test series; and</text> </paragraph> <paragraph num="(c)"> <text>The amount of procurement or processing charge of the licensed physician, if any, for each specimen taken;</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Makes a willful misrepresentation in treatment;</text> </paragraph> <paragraph num="(18)"> <text>Practices medicine with an unauthorized person or aids an unauthorized person in the practice of medicine;</text> </paragraph> <paragraph num="(19)"> <text>Grossly over-utilizes health care services;</text> </paragraph> <paragraph num="(20)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(21)"> <text>Is disciplined by a licensing or disciplinary authority or convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under Health Occupations Article, §15-314, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(22)"> <text>Fails to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care performed in an outpatient surgical facility, office, hospital, or any other location in this State;</text> </paragraph> <paragraph num="(23)"> <text>Willfully submits false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(24)"> <text>Was subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under this regulation and the licensee:</text> <paragraph num="(a)"> <text>Surrendered the license issued by the state or country to the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(26)"> <text>Fails to educate a patient being treated for breast cancer of alternative methods of treatment as required by Health-General Article, §20-113, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(27)"> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(28)"> <text>Fails to comply with the provisions of Health Occupations Article, §12-102, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(29)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(30)"> <text>Except as to an association that has remained in continuous existence since July 1, 1963:</text> <paragraph num="(a)"> <text>Associates with a pharmacist as a partner or co-owner of a pharmacy for the purpose of operating a pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Employs a pharmacist for the purpose of operating a pharmacy; or</text> </paragraph> <paragraph num="(c)"> <text>Contracts with a pharmacist for the purpose of operating a pharmacy;</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>Except in an emergency life-threatening situation where it is not feasible or practicable, fails to comply with the Centers for Disease Control and Prevention's guidelines on universal precautions;</text> </paragraph> <paragraph num="(32)"> <text>Fails to display the notice required under Health Occupations Article, §14-415, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(33)"> <text>Fails to cooperate with a lawful investigation conducted by the Board;</text> </paragraph> <paragraph num="(34)"> <text>Is convicted of insurance fraud as defined in Insurance Article, §27-801, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(35)"> <text>Is in breach of a service obligation resulting from the applicant's or licensee's receipt of State or federal funding for the licensee's medical education;</text> </paragraph> <paragraph num="(36)"> <text>Willfully makes a false representation when seeking or making application for licensure or any other application related to the practice of medicine;</text> </paragraph> <paragraph num="(37)"> <text>By corrupt means, threats, or force, intimidates or influences, or attempts to intimidate or influence, for the purpose of causing any person to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings;</text> </paragraph> <paragraph num="(38)"> <text>By corrupt means, threats, or force, hinders, prevents, or otherwise delays any person from making information available to the Board in furtherance of any investigation of the Board;</text> </paragraph> <paragraph num="(39)"> <text>Intentionally misrepresents credentials for the purpose of testifying or rendering an expert opinion in hearings or proceedings before the Board, a disciplinary panel, or those otherwise delegated by the Office of Administrative Hearings;</text> </paragraph> <paragraph num="(40)"> <text>Fails to keep adequate medical records;</text> </paragraph> <paragraph num="(41)"> <text>Performs medical acts in a manner that is not consistent with the collaboration agreement;</text> </paragraph> <paragraph num="(42)"> <text>Performs medical acts which are outside the education, training, and experience of the physician assistant;</text> </paragraph> <paragraph num="(43)"> <text>Performs medical acts that are not customary to the practice of the patient care team physicians listed on the collaboration agreement;</text> </paragraph> <paragraph num="(44)"> <text>Practices as a physician assistant without first providing notice to the Board as required under Health Occupations Article, §15–302(A), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(45)"> <text>Fails to complete a criminal history records check under Health Occupations Article, §14–308.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(46)"> <text>Fails to comply with the requirements of the Prescription Drug Monitoring Program set forth in Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(47)"> <text>Fails to comply with any State or federal law or regulation pertaining to the practice of a physician assistant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unprofessional conduct in the practice of medicine, Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing the physician's duty to supervise the physician assistant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Reports by Employers and Patient Care Team Physician."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a hospital, related institution, alternative health care system, and employer physician shall file with the Board a report that the hospital, related institution, alternative health system, or employer physician limited, reduced, otherwise changed, or terminated any licensee for any reason that might be grounds for disciplinary action under Regulation .13 of this chapter or Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Exception. A hospital, related institution, alternative health system, or employer that has reason to know that a licensee has committed an action or has a condition that might be grounds for reprimand or probation of the licensee or suspension or revocation of the licensure because the licensee is alcohol impaired or drug impaired is not required to report the licensee to the Board if:</text> <paragraph num="(1)"> <text>The hospital, related institution, alternative health system, or employer knows that the licensee is:</text> <paragraph num="(a)"> <text>In an alcohol or drug treatment program that is accredited by the Joint Commission or is certified by the Maryland Department of Health; or</text> </paragraph> <paragraph num="(b)"> <text>Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital, related institution, alternative health system, or employer is able to verify that the licensee remains in the treatment program until discharge; and</text> </paragraph> <paragraph num="(3)"> <text>The action or condition of the licensee or holder of a temporary license has not caused injury to any person while the licensee or holder of a temporary license is practicing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice by Licensee.</text> <paragraph num="(1)"> <text>If the licensee enters, or is considering entering, an alcohol or drug treatment program that is accredited by the Joint Commission or that is certified by the Maryland Department of Health, the licensee shall notify the hospital, related institution, alternative health system, employer, or patient care team physician of the licensee's or holder's decision to enter the treatment program.</text> </paragraph> <paragraph num="(2)"> <text>If the licensee fails to provide the notice required under §C(1) of this regulation, and the hospital, related institution, alternative health system, employer, or patient care team physicians learn that the licensee has entered a treatment program, the hospital, related institution, alternative health system, employer, or patient care team physician shall report to the Board that the licensee has entered a treatment program and has failed to provide the required notice.</text> </paragraph> <paragraph num="(3)"> <text>If the licensee is found to be noncompliant with the treatment program's policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, employer, or patient care team physician of the licensee's noncompliance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Examination and Audit of Physician Assistant Practice."> <paragraph num="A."> <text>Examination.</text> <paragraph num="(1)"> <text>The Board may direct a physician assistant who is an applicant or licensee to submit to an appropriate examination to determine the physician assistant’s physical, mental, or professional ability to perform delegated medical acts.</text> </paragraph> <paragraph num="(2)"> <text>A physician assistant is deemed to have consented to an examination and waived any claim to privilege as to the examination report.</text> </paragraph> <paragraph num="(3)"> <text>The unreasonable failure or refusal of an applicant or licensee to submit to an examination is:</text> <paragraph num="(a)"> <text>Prima facie evidence that the physician assistant cannot perform delegated medical acts; and</text> </paragraph> <paragraph num="(b)"> <text>Cause for denial of an application or suspension of a license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Entry.</text> <paragraph num="(1)"> <text>The executive director of the Board or other authorized representative or investigator may enter at any reasonable hour a place of business of a physician or physician assistant or into public premises:</text> <paragraph num="(a)"> <text>For the purpose of an audit to verify general compliance with the Maryland Physician Assistants Act; or</text> </paragraph> <paragraph num="(b)"> <text>To investigate an allegation with respect to a physician assistant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A person may not deny or interfere with an entry under §B(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>A person who violates any provision of §B(1) of this regulation is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Audit.</text> <paragraph num="(1)"> <text>The Board’s representatives may require a physician, physician assistant, or facility where the physician assistant is employed or practicing to provide immediate access to any records relating to the physician assistant’s employment, credentialing, and practice and any medical records of patients seen by the physician assistant.</text> </paragraph> <paragraph num="(2)"> <text>The Board’s representative shall refer possible compliance issues to:</text> <paragraph num="(a)"> <text>The compliance section of the Board; or</text> </paragraph> <paragraph num="(b)"> <text>An outside agency that has jurisdiction over a facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A physician, physician assistant, or facility who fails to comply with a Board audit in accordance with §C(1) of this regulation is subject to an administrative fine.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Practice During a Disaster."> <paragraph num="A."> <text>A physician assistant who is licensed in this State or in any other state or who is an employee of the federal government is authorized to perform acts, tasks, or functions as a physician assistant during a disaster within a county in which a state of disaster has been declared by the Governor, or counties contiguous to a county in which a state of disaster has been declared, in accordance with Public Safety Article, §14-107, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The physician assistant shall notify the Board in writing of their name, practice locations, and telephone numbers for the physician assistant within 30 days of the first performance of medical acts, tasks, or functions as a physician assistant during the disaster.</text> </paragraph> <paragraph num="C."> <text>A team of physicians and physician assistants or physician assistants practicing under this regulation may not be required to maintain on-site documentation describing collaboration agreements as otherwise required in Regulation .06 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Fees."> <text>The following fees are applicable to physician assistants:</text> <paragraph num="A."> <text>Application fees:</text> <paragraph num="(1)"> <text>Initial application — $310</text> </paragraph> <paragraph num="(2)"> <text>Endorsement application — $100</text> </paragraph> <paragraph num="(3)"> <text>Reciprocity application — $100; and</text> </paragraph> <paragraph num="(4)"> <text>Reinstatement application — $400;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Physician Assistant license fee per month until expiration of license .—. $10;</text> </paragraph> <paragraph num="C."> <text>Renewal fees:</text> <paragraph num="(1)"> <text>License renewal fee .—. $360;</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee ... As determined by MHCC under COMAR 10.25.03; and</text> </paragraph> <paragraph num="(3)"> <text>Preceptor fee — as determined in accordance with Health Occupations Article, §15–206(a)(2)(i), Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Written verification of licensure .—. $25; and</text> </paragraph> <paragraph num="E."> <text>Advanced Duty Application Fee — $100.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Sanctioning and Imposition of Fines."> <paragraph num="A."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections A and B of this regulation and Regulation .18A and B of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B of this regulation, for violations of the sections of the Physician Assistants Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction.</text> </paragraph> <paragraph num="(c)"> <text>The addition of a fine does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .18 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .18 of this chapter, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .18 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Fines for Unauthorized Practice as a Physician Assistant.</text> <paragraph num="(1)"> <text>The Board may impose a fine not exceeding $5,000 as provided in §C(2) of this regulation for unauthorized practice as a physician assistant in violation of Health Occupations Article, §15-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Factors in determining the amount of a fine include, but are not limited to the following:</text> <paragraph num="(a)"> <text>The extent to which the respondent derived any financial benefit from the improper conduct;</text> </paragraph> <paragraph num="(b)"> <text>The willfulness of the improper conduct;</text> </paragraph> <paragraph num="(c)"> <text>The extent of actual or potential public harm caused by the improper conduct; and</text> </paragraph> <paragraph num="(d)"> <text>The deterrent effect of the fine.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board shall pay all monies collected pursuant to §C of this regulation into the Board of Physicians' fund.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Employment of Unauthorized Individuals.</text> <paragraph num="(1)"> <text>A licensed physician, hospital, related institution, alternative health system, or employer may not employ an individual practicing as a physician assistant who does not have a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensed physician may not supervise an individual practicing as a physician assistant who does not have a license.</text> </paragraph> <paragraph num="(3)"> <text>The Board may impose a fine of up to $1,000 for a violation of §D(1) or (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Any funds collected under §D(3) of this regulation shall be deposited into the State's General Fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Other Fines.</text> <paragraph num="(1)"> <text>The Board may impose a fine of $100 for a violation of Health Occupations Article, §15-309, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall pay all monies collected pursuant to §E(1) of this regulation into the Board of Physicians' fund.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Offenses Related to Continuing Medical Education Credits.</text> <paragraph num="(1)"> <text>First Offense of Failure to Document Credits.</text> <paragraph num="(a)"> <text>Except as provided in §F(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §15-307(f), Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §15-314, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Section F(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §15-314(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §15-314(a)(11), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §15-314(a)(36), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §15-314 or 15-316, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees Previously Disciplined Under §F(1) or (2) of this Regulation.</text> <paragraph num="(a)"> <text>If a licensee has been previously fined or otherwise disciplined under §F(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §15-314(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §15-314(a)(11), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §15-314(a)(36), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §15-314 or 15-316, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(c)"> <text>The Board may not apply the sanction described in §F(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall pay all monies collected pursuant to §F of this regulation into the State's General Fund.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-606, 14-205, 15-101—15-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 1975 (2:12 Md. R. 870)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 26, 1981 (8:21 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .05F amended effective September 27, 1982 (9:19 Md. R. 1895)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05B-1 and .09A-1 adopted effective September 27, 1982 (9:19 Md. R. 1895)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed effective March 18, 1991 (18:5 Md. R. 594)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted effective March 18, 1991 (18:5 Md. R. 594)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02, .03, .06, .10, and .11 amended; Regulations .07—.09 and .12 repealed; and new Regulations .07—.09, .12, and .15 adopted as an emergency provision effective August 12, 1999 (26:18 Md. R. 1369); amended permanently effective January 24, 2000 (27:1 Md. R. 76)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .05—.07 amended and new Regulation .06-1 adopted as an emergency provision effective November 8, 1996 (23:24 Md. R. 1676); emergency status expired October 1, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 2, 1997 (24:17 Md. R. 1214); July 12, 1999 (26:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 12, 1999 (26:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective October 2, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective November 22, 1993 (20:23 Md. R. 1804); October 2, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective October 2, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C adopted effective October 2, 1997 (24:17 Md. R. 1214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective April 25, 1994 (21:8 Md. R. 673)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective July 12, 1999 (26:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective July 12, 1999 (26:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 1, 2004 (31:7 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); adopted permanently effective January 15, 2007 (34:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); amended permanently effective January 15, 2007 (34:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); amended permanently effective January 15, 2007 (34:1 Md. R. 32)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 18, 2011 (38:19 Md. R. 1146); revised permanently effective October 3, 2011 (38:20 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective January 18, 2016 (43:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F adopted effective November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 18, 2016 (43:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 299); emergency status expired effective July 3, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective July 22, 2013 (40:14 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted effective July 22, 2013 (40:14 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.32.03 cited in Attorney General Opinion No. 86-008 (February 18, 1986)</annotation> </annotations> </chapter> <chapter num="04" heading="Delegation of Duties by a Licensed Physician-Psychiatrist to a Psychiatrist's Assistant"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter concerns the registration of psychiatrist's assistants before October 1, 1993, and re-registration and discipline of psychiatrist's assistants currently registered by the Board of Physicians.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means the registered psychiatrist's assistant and supervisory psychiatrist who applied to the Board on or before October 1, 1993, for approval of duties and supervision.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Facility” means a:</text> <paragraph num="(a)"> <text>Hospital;</text> </paragraph> <paragraph num="(b)"> <text>Nursing home;</text> </paragraph> <paragraph num="(c)"> <text>Health maintenance organization;</text> </paragraph> <paragraph num="(d)"> <text>Community health center;</text> </paragraph> <paragraph num="(e)"> <text>Public health clinic;</text> </paragraph> <paragraph num="(f)"> <text>Similar institution; or</text> </paragraph> <paragraph num="(g)"> <text>Medical office of more than one psychiatrist.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Psychiatrist” means an individual licensed to practice medicine in Maryland who has completed the psychiatric residency requirements in a program approved by the American Board of Psychiatry and Neurology or who has received, or is eligible for, certification by the American Board of Psychiatry and Neurology.</text> </paragraph> <paragraph num="(5)"> <text>“Psychiatrist's assistant” means an individual who applied for registration on or before October 1, 1993, and was registered by the Board to perform medical duties which would normally be performed by a psychiatrist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permitted Assignment of Duties."> <text>A psychiatrist may assign duties which constitute the practice of medicine to a psychiatrist's assistant in accordance with these regulations.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards for Psychiatrist Supervision of Psychiatrist's Assistants."> <paragraph num="A."> <text>The psychiatrist shall personally examine, diagnose, and establish a treatment plan for each patient before assigning a patient to a psychiatrist's assistant.</text> </paragraph> <paragraph num="B."> <text>Adequate supervision of a psychiatrist's assistant in the performance of medical acts under these regulations requires the personal presence of the psychiatrist or the psychiatrist's participation through telephone contact, chart review, or other means as approved by the Board, or all of the above.</text> </paragraph> <paragraph num="C."> <text>Adequate supervision does not necessarily require on-site supervision in all cases.</text> </paragraph> <paragraph num="D."> <text>When in the performance of his medical duties, a psychiatrist's assistant finds a significant, new undiagnosed condition or a significant change in an existing diagnosed illness, the psychiatrist's assistant shall immediately apprise the supervising psychiatrist of the condition or change. The supervising psychiatrist shall then direct appropriate treatment and shall be available to promptly attend the patient.</text> </paragraph> <paragraph num="E."> <text>A psychiatrist may not employ more than two full-time psychiatrist's assistants in a non institutional practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration and Re-registration."> <paragraph num="A."> <text>After October 1, 1993, the Board may not accept or approve any application for registration.</text> </paragraph> <paragraph num="B."> <text>An individual who has been registered by the Board as a psychiatrist's assistant pursuant to this chapter shall renew the registration every 2 years on the date specified by the Board by re-registration and payment of the appropriate fees. A registrant shall meet all the requirements of this chapter at re-registration.</text> </paragraph> <paragraph num="C."> <text>A psychiatrist's assistant shall notify the Board in writing of a change in the psychiatrist’s assistant name or address within 60 days after the change.</text> </paragraph> <paragraph num="D."> <text>Notice of the required re-registration shall be given by the Board to the psychiatrist's assistant at the address as shown on the records of the Board.</text> </paragraph> <paragraph num="E."> <text>The psychiatrist's assistant shall complete this re-registration by the date specified by the Board.</text> </paragraph> <paragraph num="F."> <text>If a psychiatrist's assistant does not receive notice of re-registration it shall be the responsibility of the psychiatrist’s assistant to contact the Board in order to complete this re-registration before the expiration of the current registration.</text> </paragraph> <paragraph num="G."> <text>A psychiatrist's assistant whose registration has expired for failure to renew is unregistered. A registration which has expired shall be considered permanently expired.</text> </paragraph> <paragraph num="H."> <text>For purposes of the re-registration, appropriate standards for continuing medical education for psychiatrist's assistants may be promulgated by the Board.</text> </paragraph> <paragraph num="I."> <text>When the registration expires, the approval of duties and supervision becomes invalid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Approval of Duties and Supervision."> <paragraph num="A."> <text>When a physician or facility and a psychiatrist's assistant have agreed to the psychiatrist's assistant's employment, the two parties shall provide the Board with a written application for approval of duties and supervision before the psychiatrist's assistant begins his duties.</text> </paragraph> <paragraph num="B."> <text>A psychiatrist's assistant may not begin employment until a notice of approval of duties and supervision is issued by the Board to the physician or facility and the psychiatrist's assistant.</text> </paragraph> <paragraph num="C."> <text>Application for Approval of Duties and Supervision.</text> <paragraph num="(1)"> <text>The application shall be made on a form supplied by the Board and shall include:</text> <paragraph num="(a)"> <text>A complete list and description of the duties to be assigned to the psychiatrist's assistant.</text> </paragraph> <paragraph num="(b)"> <text>A detailed description of the supervisory relationship between the psychiatrist and the psychiatrist's assistant or the psychiatrists in a facility and the psychiatrist's assistant. The description of the supervisory relationship shall include a schedule of patient reviews.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Facility employers of psychiatrist's assistants shall submit to the Board for approval:</text> <paragraph num="(a)"> <text>The name of a principal psychiatrist who will be responsible for the assigned duties and supervision of all psychiatrist's assistants;</text> </paragraph> <paragraph num="(b)"> <text>The total number of psychiatrist's assistants to be employed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The application shall be signed by the psychiatrist and the psychiatrist's assistant or, if a facility, by the principal psychiatrist and all supervising psychiatrists and the psychiatrist's assistant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall notify the psychiatrist's assistant and the psychiatrist or facility of its approval or disapproval of the duties and supervisory relationship within 60 days of receipt of the notice of employment.</text> </paragraph> <paragraph num="E."> <text>The Board may approve an application in whole or in part, based upon the applicant's education and experience.</text> </paragraph> <paragraph num="F."> <text>The Board shall have the authority to review the practice and supervisory relationship of a psychiatrist's assistant and psychiatrist or facility's psychiatrist at any time for conformance with these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Termination of Employment."> <text>Notice shall be given to the Board by the psychiatrist or the facility and the psychiatrist's assistant within 10 days of termination of employment.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsibility of the Psychiatrist."> <paragraph num="A."> <text>A record of patient reviews with the psychiatrist's assistant shall be kept on file and shall include a summary of the psychiatrist's observations and recommendations.</text> </paragraph> <paragraph num="B."> <text>A psychiatrist may not assign the ultimate responsibility for diagnosis or therapy to a psychiatrist's assistant.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding any provision contained in these regulations, a psychiatrist may not assign to a psychiatrist's assistant the duty of independently prescribing or dispensing drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Psychiatrist's Responsibility to Patient not to be Limited by Assignment."> <text>When the Board approves a psychiatrist's assistant's duties and supervisory relationship with a psychiatrist, that approval does not relieve the psychiatrist from the primary responsibility for the care and treatment of the patient. Medical services rendered to a patient by a psychiatrist's assistant shall be, with respect to the obligation of the psychiatrist, the same as if those services had been rendered directly by the psychiatrist.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Fees."> <text>The Board shall establish fees for application, registration, re-registration, late registration, and reinstatement of psychiatrist's assistants.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Identification of the Psychiatrist's Assistant."> <paragraph num="A."> <text>The psychiatrist's assistant shall wear a tag or badge with lettering clearly visible to the patient, bearing his name and the title “Registered Psychiatrist's Assistant”. The use of any other degree designation either on the badge or in any other phase of practice as a psychiatrist's assistant is prohibited.</text> </paragraph> <paragraph num="B."> <text>A patient calling or walking in for an appointment shall be clearly notified at that time whether he will be seeing the psychiatrist or the psychiatrist's assistant.</text> </paragraph> <paragraph num="C."> <text>A psychiatrist's assistant may not represent himself as a psychiatrist's assistant in any employment unless an application for approval of duties and supervision has been approved by the Board.</text> </paragraph> <paragraph num="D."> <text>The Board shall maintain a registry of psychiatrist's assistants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Hearings Following Denial of Application or Re-Registration."> <paragraph num="A."> <text>If the Board disapproves an application for approval of duties and supervision, it shall give notice to the applicant and set forth the specific reasons for the denial. The applicant shall have the right to appear before the Board and be heard.</text> </paragraph> <paragraph num="B."> <text>If the applicant desires to be heard, he shall make a written request for a hearing within 10 days of the receipt of the notice of disapproval of his application. The hearing shall be held within 60 days after the written request has been filed.</text> </paragraph> <paragraph num="C."> <text>At the hearing the applicant may be represented by counsel and may present witnesses and other evidence on his behalf.</text> </paragraph> <paragraph num="D."> <text>The Board shall affirm, reverse, or modify its previous disapproval and give the applicant written notice of the action which it has taken within 30 days after the hearing, unless the applicant agrees to a longer period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Prohibited Conduct, Hearings, and Appeals."> <paragraph num="A."> <text>For the commission of a prohibited act, subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, on the affirmative vote of a majority of its full, authorized membership, the Board may:</text> <paragraph num="(1)"> <text>Reprimand any psychiatrist's assistant;</text> </paragraph> <paragraph num="(2)"> <text>Place any psychiatrist's assistant on probation; or</text> </paragraph> <paragraph num="(3)"> <text>Suspend or revoke the registration of a psychiatrist's assistant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following are prohibited acts:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtaining, or attempting to obtain, a registration for the applicant or certified individual or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively using a registration;</text> </paragraph> <paragraph num="(3)"> <text>Being guilty of unprofessional or immoral conduct in the practice of psychiatry as a psychiatrist's assistant;</text> </paragraph> <paragraph num="(4)"> <text>Being professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Habitually being intoxicated;</text> </paragraph> <paragraph num="(6)"> <text>Being addicted to, or habitually abusing, any narcotic or controlled dangerous substance as defined in Criminal Law Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Providing professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol, or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Willfully making or filing a false report or record in the practice of psychiatry as a psychiatrist's assistant or aiding another individual to do so;</text> </paragraph> <paragraph num="(9)"> <text>Willfully failing to file or record any report as required under law, willfully impeding or obstructing the filing or recording of a report, or inducing another to fail to file or record a report;</text> </paragraph> <paragraph num="(10)"> <text>Making a willful misrepresentation in treatment;</text> </paragraph> <paragraph num="(11)"> <text>Practicing as a psychiatrist's assistant with an unauthorized individual or aiding an unauthorized individual in practice as a psychiatrist's assistant;</text> </paragraph> <paragraph num="(12)"> <text>Being disciplined by a licensing or disciplinary authority or being convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under this regulation;</text> </paragraph> <paragraph num="(13)"> <text>Failing to meet appropriate standards for the delivery of quality performance as a psychiatrist's assistant in this State;</text> </paragraph> <paragraph num="(14)"> <text>Willfully submitting false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-903, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(16)"> <text>Selling, prescribing, giving away, or administering medical prescription drugs, narcotics, or controlled dangerous substances, as defined in Criminal Law Article, Annotated Code of Maryland, for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(17)"> <text>Breaching patient confidentiality;</text> </paragraph> <paragraph num="(18)"> <text>Practicing beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(19)"> <text>Performing delegated medical acts other than under the supervision of a psychiatrist approved by the Board;</text> </paragraph> <paragraph num="(20)"> <text>Refusing, withholding from, denying, or discriminating against a patient with regard to the provision of professional services for which the psychiatrist's assistant is registered and qualified to render because the patient may be HIV positive;</text> </paragraph> <paragraph num="(21)"> <text>Practicing or attempting to practice any delegated act as a psychiatrist's assistant without having received education, internship, training, or experience in the performance of that procedure;</text> </paragraph> <paragraph num="(22)"> <text>Soliciting professional patronage through an agent or other individuals or profits from the acts of an individual who is represented as an agent of the psychiatrist's assistant;</text> </paragraph> <paragraph num="(23)"> <text>Paying or agreeing to pay any sum to an individual for bringing or referring a patient or accepting or agreeing to accept any sum from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(24)"> <text>Failing to comply with these regulations;</text> </paragraph> <paragraph num="(25)"> <text>On proper request, failing to provide, in writing, details of a patient's records to another health care provider, institution, or hospital; and</text> </paragraph> <paragraph num="(26)"> <text>Except in an emergency life-threatening situation, failing to comply with the Centers for Disease Control's guidelines on universal precautions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Crimes Involving Moral Turpitude.</text> <paragraph num="(1)"> <text>Subject to the Administrative Procedure Act, the Board shall order the suspension of a registration of a psychiatrist's assistant if the psychiatrist's assistant is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process, if the conviction has not be reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a psychiatrist's assistant's registration subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Surrender. Unless the Board agrees to accept the surrender of a registration, a psychiatrist's assistant may not surrender the registration nor may the registration lapse by operation of law while the psychiatrist's assistant is under investigation or while charges are pending against the assistant.</text> </paragraph> <paragraph num="E."> <text>Unprofessional Conduct. Unprofessional conduct in the practice of medicine as defined by Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing supervising physicians and psychiatrist's assistants.</text> </paragraph> <paragraph num="F."> <text>Complaints. Individuals may refer complaints alleging prohibited conduct to the Board to be investigated according to the Board's procedures.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-205, 14-302, and 14-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 24, 1982 (9:10 Md. R. 1022)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 8, 1995 (22:9 Md. R. 645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 10, 2016 (43:20 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 10, 2016 (43:20 Md. R. 1110)</annotation> </annotations> </chapter> <chapter num="05" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the practice of medicine using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(3)"> <text>“Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>Telehealth.</text> <paragraph num="(a)"> <text>“Telehealth” means a mode of delivering health care services through the use of telecommunications technologies by a health care practitioner to a patient at a different physical location than the telehealth practitioner.</text> </paragraph> <paragraph num="(b)"> <text>“Telehealth” includes synchronous and asynchronous interactions.</text> </paragraph> <paragraph num="(c)"> <text>“Telehealth” does not include the provision of health care services solely through:</text> <paragraph num="(i)"> <text>Audio–only calls;</text> </paragraph> <paragraph num="(ii)"> <text>E–mail messages; or</text> </paragraph> <paragraph num="(iii)"> <text>Facsimile transmissions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means a Maryland licensed physician or licensed allied health practitioner performing telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <paragraph num="A."> <text>Except as specified in Health Occupations Article, §14-302, Annotated Code of Maryland, a telehealth practitioner shall be licensed when providing telehealth services to a patient located in the State.</text> </paragraph> <paragraph num="B."> <text>Telehealth practitioners licensed in the State are subject to the jurisdiction of the State and shall abide by the telehealth requirements of this chapter if either the practitioner or patient is physically located in this State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Specific Telehealth Requirements."> <paragraph num="A."> <text>Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services within a reasonable degree of certainty through use of:</text> <paragraph num="(a)"> <text>Government issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>Insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient encounter, disclose the telehealth practitioner’s name, contact information, license type, and medical specialty, if any;</text> </paragraph> <paragraph num="(3)"> <text>Except for interpretive services, obtain oral or written consent from a patient or the patient’s parent or guardian if State law requires the consent of a parent or guardian including informing patients of the risks, benefits, and side effects of prescribed treatments;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical information, clinical data, clinical images, laboratory results, and self–reported medical history, as necessary and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private telehealth connection that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear personal health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The requirements set forth under §§A and B of this regulation may be delegated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>A telehealth practitioner shall perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing treatment or issuing a prescription through telehealth.</text> </paragraph> <paragraph num="B."> <text>A telehealth practitioner shall, if clinically appropriate for the patient, provide or refer a patient to in-person health care services or another type of telehealth service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standard Related to Telehealth."> <paragraph num="A."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable in in-person health care settings.</text> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient or prescribe medication based solely on a static online questionnaire.</text> </paragraph> <paragraph num="C."> <text>A telehealth practitioner may not prescribe an opiate described in the list of Schedule II substances under Criminal Law Article, §5-403, Annotated Code of Maryland for the treatment of pain through telehealth unless:</text> <paragraph num="(1)"> <text>The patient is in a health care facility as defined in Health-General Article, §19-114(d)(1), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>The Governor has declared a state of emergency due to a catastrophic health emergency; or</text> </paragraph> <paragraph num="(3)"> <text>There is an established bona fide practitioner-patient relationship in which the telehealth practitioner has ongoing responsibility for the assessment, care, and treatment of the patient and the telehealth practitioner, or another health care practitioner in the same group practice, as defined in Health Occupations Article, §1-301, Annotated Code of Maryland, previously conducted an in-person assessment of the patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A telehealth practitioner shall comply with all State and federal laws and regulations related to dispensing including the prohibition on mail order dispensing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards in evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with Regulation .04, .05, or .06 of this chapter shall constitute unprofessional conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-606, 1-1003, 1-1006, 14-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 28, 2009 (36:26 Md. R. 1995)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07, Telemedicine, repealed and new Regulations .01—.07, Telehealth, adopted effective August 12, 2019 (46:16 Md. R. 688)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 B, C amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective September 15, 2025 (52:18 Md. R. 923)</annotation> </annotations> </chapter> <chapter num="06" heading="Licensure of Polysomnographic Technologists"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of polysomnographic technology.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C or D of this regulation, on or before October 1, 2013, an individual shall be licensed by the Board before the individual may practice polysomnography.</text> </paragraph> <paragraph num="C."> <text>This chapter does not prohibit any polysomnographic technology student who is currently enrolled in an approved polysomnographic technology educational program from performing any of the procedures described in this chapter as part of that program's polysomnographic technology clinical curriculum.</text> </paragraph> <paragraph num="D."> <text>This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>This chapter does not prohibit a licensed respiratory care practitioner from practicing respiratory care within the scope of practice of the respiratory care practitioner’s license, including practicing respiratory care in a sleep laboratory.</text> </paragraph> <paragraph num="F."> <text>This chapter does not prohibit the practice of respiratory care by a practitioner who was licensed by the Board to practice respiratory care on or before December 31, 2012, and whose duties include practicing polysomnography.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(2)"> <text>“Board eligible” means a physician’s status that starts upon completion of all the requirements to take a sleep medicine certifying examination and lasts for a limited period of time, as determined by the American Board of Medical Specialties or the American Osteopathic Association.</text> </paragraph> <paragraph num="(3)"> <text>“Capnography” means measurement of the amount of CO2 being eliminated from the lungs.</text> </paragraph> <paragraph num="(4)"> <text>“Committee” means the Polysomnography Professional Standards Committee established under Health Occupations Article, §14-5C-05, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means supervision by a licensed physician who is physically present on the premises while services are provided.</text> </paragraph> <paragraph num="(6)"> <text>“Electroencephalography” means a test that measures the electrical activity of the brain as recorded by electrodes placed on the scalp.</text> </paragraph> <paragraph num="(7)"> <text>“Electromyography” means a test that measures the electrical activity of the muscles.</text> </paragraph> <paragraph num="(8)"> <text>“Electrooculography” means a test that measures the movements of the eye.</text> </paragraph> <paragraph num="(9)"> <text>“Enrolled in a sleep technologist educational program” means that a student has started the Accredited Sleep Technology Program self-study online modules developed by the American Academy of Sleep Medicine but has not completed the final self-study module.</text> </paragraph> <paragraph num="(10)"> <text>“General supervision” means supervision by a licensed physician who is available to give immediately available direction, either in person, by telephone, or by electronic means.</text> </paragraph> <paragraph num="(11)"> <text>“License” means a license issued by the Board.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed polysomnographic technologist” means an individual licensed by the Board to practice polysomnography under the supervision of a licensed physician.</text> </paragraph> <paragraph num="(13)"> <text>“Licensed physician” means an individual who is licensed by the Board to practice medicine.</text> </paragraph> <paragraph num="(14)"> <text>“Oximetry” means a test that measures the concentration of oxygen in the blood.</text> </paragraph> <paragraph num="(15)"> <text>“PH probe” means a device to measure the acidity of the esophagus.</text> </paragraph> <paragraph num="(16)"> <text>“Plethysmography” means a test to measure changes in blood flow or air volume in different parts of the body.</text> </paragraph> <paragraph num="(17)"> <text>“Practice polysomnography” means:</text> <paragraph num="(a)"> <text>Monitoring and recording physiologic data during sleep, including sleep-related respiratory disturbances, under the supervision of a licensed physician; and</text> </paragraph> <paragraph num="(b)"> <text>Using the data collected under §B(17)(a) of this regulation for the purposes of assisting a licensed physician in the diagnosis and treatment of sleep and wake disorders.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Registered polysomnographic technologist” means a polysomnographic technologist who is registered by the Board of Registered Polysomnographic Technologists.</text> </paragraph> <paragraph num="(19)"> <text>“Student” means an individual who is:</text> <paragraph num="(a)"> <text>Enrolled in an accredited educational program in order to qualify for a license as a polysomnographic technologist; and</text> </paragraph> <paragraph num="(b)"> <text>Performing polysomnography services within the accredited program under the supervision of a licensed physician and without compensation.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Supervision” means general supervision or direct supervision of a licensed polysomnographic technologist by a licensed physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Committee."> <paragraph num="A."> <text>The Board shall appoint members of the Polysomnographic Professional Standards Committee as follows:</text> <paragraph num="(1)"> <text>Three polysomnographic technologists who:</text> <paragraph num="(a)"> <text>Before October 1, 2009, are registered polysomnographic technologists; and</text> </paragraph> <paragraph num="(b)"> <text>On or after October 1, 2009, are both registered polysomnographic technologists and licensed polysomnographic technologists;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Three licensed physicians with specialty certification in sleep medicine who are specialists in the following areas:</text> <paragraph num="(a)"> <text>One in psychiatry or internal medicine;</text> </paragraph> <paragraph num="(b)"> <text>One in pulmonary medicine; and</text> </paragraph> <paragraph num="(c)"> <text>One in neurology; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One consumer member who is a member of the general public and who:</text> <paragraph num="(a)"> <text>May not be or ever has been:</text> <paragraph num="(i)"> <text>A polysomnographic technologist;</text> </paragraph> <paragraph num="(ii)"> <text>A health care professional;</text> </paragraph> <paragraph num="(iii)"> <text>In training to be a polysomnographic technologist or other health care professional; or</text> </paragraph> <paragraph num="(iv)"> <text>A household member of a health care professional or an individual in training to be a health care professional; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May not:</text> <paragraph num="(i)"> <text>Participate, or ever have participated, in a commercial or professional field related to polysomnography;</text> </paragraph> <paragraph num="(ii)"> <text>Have a household member who participates in a commercial or professional field related to polysomnography;</text> </paragraph> <paragraph num="(iii)"> <text>Have had, within 2 years before appointment, a financial interest in a individual regulated by the Board; or</text> </paragraph> <paragraph num="(iv)"> <text>Have had, within 2 years before appointment, a financial interest in the provision of goods or services to polysomnographic technologists or to the field of polysomnography.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second term but the individual may not serve more than two full consecutive terms.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs, the Board shall appoint a new member to serve.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall only serve for the remainder of the term, unless reappointed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the members then serving on the Committee is a quorum.</text> </paragraph> <paragraph num="(2)"> <text>Business may not be conducted at a Committee meeting unless there is a quorum.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Make recommendations to the Board regarding the practice of, and regulations governing, polysomnographic technologists;</text> </paragraph> <paragraph num="(2)"> <text>Make recommendations to the Board on the requirements for licensure as a polysomnographic technologist;</text> </paragraph> <paragraph num="(3)"> <text>Review selected applications for licensure as a polysomnographic technologist and make recommendations to the Board on the applications;</text> </paragraph> <paragraph num="(4)"> <text>At the request of the Board, review complaints against polysomnographic technologists and respond to the Board's questions; and</text> </paragraph> <paragraph num="(5)"> <text>Keep a record of the Committee's proceedings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application for Initial Licensure as a Polysomnographic Technologist."> <paragraph num="A."> <text>An applicant shall:</text> <paragraph num="(1)"> <text>Complete an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the required application fee set by the Board in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrate spoken and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of graduation from a recognized English-speaking professional school; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of receiving a grade of at least:</text> <paragraph num="(i)"> <text>26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provide documentation of current certification as a registered polysomnographic technologist by the Board of Registered Polysomnographic Technologists or by another national certification agency approved by the Board;</text> </paragraph> <paragraph num="(7)"> <text>Provide documentation of licensure, certification, or registration from all states where the applicant has ever held a license, certificate, or registration in any health profession; and</text> </paragraph> <paragraph num="(8)"> <text>Meet the requirements of §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall meet the requirements of one of the following pathways to licensure:</text> <paragraph num="(1)"> <text>Graduation from a polysomnographic educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs;</text> </paragraph> <paragraph num="(2)"> <text>In regard to a respiratory care educational program:</text> <paragraph num="(a)"> <text>Graduation from a respiratory care educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; and</text> </paragraph> <paragraph num="(b)"> <text>Completion of the Committee on Accreditation for Respiratory Care’s curriculum for a polysomnography certificate that is accredited by the Commission on Accreditation of Allied Health Education Programs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In regard to an electroneurodiagnostic technology educational program:</text> <paragraph num="(a)"> <text>Graduation from an electroneurodiagnostic technology educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; and</text> </paragraph> <paragraph num="(b)"> <text>Completion of an add-on track in polysomnography for electroneurodiagnostic technologists that is accredited by the Commission on Accreditation of Allied Health Education Programs; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In regard to a sleep technologist educational program, completion of the requirements of §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant who has graduated from a sleep technologist education program accredited by the American Academy of Sleep Medicine shall:</text> <paragraph num="(1)"> <text>Provide proof of meeting core competencies in the 3 years preceding the date of the submission of the licensure application as assessed by a sleep technologist credentialed as a Registered Polysomnographic Technologist, a sleep technologist with national certification approved by the Board, or a physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association;</text> </paragraph> <paragraph num="(2)"> <text>Provide a letter of attestation for completion of clinical hours and competencies from a physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association where the applicant practiced; and</text> </paragraph> <paragraph num="(3)"> <text>Provide proof of completion of a minimum of 546 hours of clinical experience in the 3 years preceding the date of the submission of the licensure application as either:</text> <paragraph num="(a)"> <text>A student enrolled in a sleep technologist educational program supervised at a sleep laboratory accredited by the American Academy of Sleep Medicine or The Joint Commission by:</text> <paragraph num="(i)"> <text>A sleep technologist credentialed as a Registered Polysomnographic Technologist;</text> </paragraph> <paragraph num="(ii)"> <text>A sleep technologist with national certification approved by the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>A licensed physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A sleep technologist with a current, active, unrestricted license in another state or is otherwise recognized and has practiced as a sleep technologist in another state who has:</text> <paragraph num="(i)"> <text>Full-time practice experience as a sleep technologist in another state at a sleep laboratory accredited by the American Academy of Sleep Medicine or The Joint Commission for a minimum of 6 months in the 3 years preceding the date of the submission of the licensure application; and</text> </paragraph> <paragraph num="(ii)"> <text>Completed at least 30 hours of approved continuing education in the 3 years preceding the date of the submission of the licensure application.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of Practice."> <paragraph num="A."> <text>A licensed polysomnographic technologist may practice only under the supervision of a licensed physician.</text> </paragraph> <paragraph num="B."> <text>A licensed polysomnographic technologist may practice only in a hospital sleep laboratory or a stand-alone sleep center.</text> </paragraph> <paragraph num="C."> <text>The scope of practice of a licensed polysomnographic technologist includes and is limited to the following:</text> <paragraph num="(1)"> <text>Monitoring and recording physiologic data during sleep, including sleep-related respiratory disturbances;</text> </paragraph> <paragraph num="(2)"> <text>Using data collected under §C(1) of this regulation to assist a licensed physician in the diagnosis and treatment of sleep and wake disorders;</text> </paragraph> <paragraph num="(3)"> <text>Assisting with the diagnosis and treatment of individuals who suffer from sleep disorders as a result of developmental defects, the aging process, physical injury, disease, or actual or anticipated somatic dysfunction;</text> </paragraph> <paragraph num="(4)"> <text>Observing and monitoring physical signs and symptoms, general behavior, and general physical responses to polysomnographic evaluation, and determining whether initiation, modification, or discontinuation of a treatment regimen is warranted;</text> </paragraph> <paragraph num="(5)"> <text>Using evaluation techniques that include limited cardiopulmonary function assessments, the need and effectiveness of therapeutic modalities and procedures, and the assessment and evaluation of the need for extended care; and</text> </paragraph> <paragraph num="(6)"> <text>Using the following techniques, equipment, and procedures:</text> <paragraph num="(a)"> <text>Continuous positive airway pressure, bi-level positive airway pressure titration, or adaptive servo-ventilation on spontaneously breathing patients;</text> </paragraph> <paragraph num="(b)"> <text>Supplemental low flow oxygen therapy during polysomnogram;</text> </paragraph> <paragraph num="(c)"> <text>Capnography during polysomnogram;</text> </paragraph> <paragraph num="(d)"> <text>Cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(e)"> <text>Pulse oximetry;</text> </paragraph> <paragraph num="(f)"> <text>PH probe placement and monitoring;</text> </paragraph> <paragraph num="(g)"> <text>Esophageal pressure;</text> </paragraph> <paragraph num="(h)"> <text>Sleep staging, including surface electroencephalography, surface electrooculography, and surface submental electromyography;</text> </paragraph> <paragraph num="(i)"> <text>Surface electromyography of arms and legs;</text> </paragraph> <paragraph num="(j)"> <text>Electrocardiography;</text> </paragraph> <paragraph num="(k)"> <text>Respiratory effort, including thoracic and abdominal;</text> </paragraph> <paragraph num="(l)"> <text>Plethysmography blood flow;</text> </paragraph> <paragraph num="(m)"> <text>Snore monitoring;</text> </paragraph> <paragraph num="(n)"> <text>Audio or video monitoring;</text> </paragraph> <paragraph num="(o)"> <text>Implementation of a written or verbal order from a licensed physician that requires the practice of polysomnography;</text> </paragraph> <paragraph num="(p)"> <text>Monitoring the effects a nasal device used to treat sleep apnea has on sleep patterns provided that the device does not extend into the trachea; and</text> </paragraph> <paragraph num="(q)"> <text>Monitoring the effects an oral device used to treat sleep apnea has on sleep patterns provided that:</text> <paragraph num="(i)"> <text>The oral device does not extend into the trachea;</text> </paragraph> <paragraph num="(ii)"> <text>A dentist has evaluated the structures of the patient's oral and maxillofacial region for purposes of fitting the oral device;</text> </paragraph> <paragraph num="(iii)"> <text>A dentist made or directed the making of the oral device; and</text> </paragraph> <paragraph num="(iv)"> <text>A dentist directs the use of the oral device.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The scope of practice of a polysomnographic technologist does not include administering medications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Identification as Polysomnographic Technologist; Notice of Name or Address Change."> <paragraph num="A."> <text>A licensed polysomnographic technologist shall wear an identification tag or a badge displaying in readily visible type that the individual is a licensed polysomnographic technologist.</text> </paragraph> <paragraph num="B."> <text>An individual may not identify himself or herself as a polysomnographic technologist unless the individual is licensed by the Board.</text> </paragraph> <paragraph num="C."> <text>Change of Name or Address.</text> <paragraph num="(1)"> <text>A licensed polysomnographic technologist shall advise the Board in writing of any change in name or mailing address within 60 days.</text> </paragraph> <paragraph num="(2)"> <text>The Board may impose a fine of $100 for failure to notify the Board of a change in name or mailing address.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal and Reinstatement."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has been licensed by the Board as a polysomnographic technologist may renew the license on or before the date specified by the Board by:</text> <paragraph num="(a)"> <text>Submitting a renewal application on a form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee set by the Board in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to the completion of at least 20 hours of approved continuing education, earned during the 2-year period preceding the expiration of the license, as specified in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Meeting any other requirement set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement. The Board shall reinstate the license of a polysomnographic technologist if the polysomnographic technologist:</text> <paragraph num="(1)"> <text>Completes a reinstatement application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays the required reinstatement fee and any other fees specified in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Documents evidence of completion of at least 20 hours of approved continuing education in the 2-year period preceding the date of the submission of the application for reinstatement, as specified in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Meets any additional requirements set by the Board for reinstatement of a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Continuing Education."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>A licensed polysomnographic technologist is not required to obtain continuing education hours for the first renewal after initial licensure or reinstatement.</text> </paragraph> <paragraph num="(2)"> <text>Except as stated in §A(1) of this regulation, the Board may not renew or reinstate the license of a polysomnographic technologist unless the polysomnographic technologist has met the requirements for continuing education described in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements.</text> <paragraph num="(1)"> <text>A polysomnographic technologist shall earn at least 20 continuing education hours as described in §B(2) of this regulation during the 2-year period preceding:</text> <paragraph num="(a)"> <text>For license renewal, the expiration of the license for polysomnographic technologist; or</text> </paragraph> <paragraph num="(b)"> <text>For license reinstatement, the date of the submission of the application for reinstatement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall recognize sleep-related continuing education hours approved by one of the following organizations or any other organization recommended by the Committee and approved by the Board:</text> <paragraph num="(a)"> <text>American Medical Association;</text> </paragraph> <paragraph num="(b)"> <text>American Association of Sleep Technologists;</text> </paragraph> <paragraph num="(c)"> <text>American Academy of Sleep Medicine;</text> </paragraph> <paragraph num="(d)"> <text>American Society of Electroneurodiagnostic Technologists, Inc.;</text> </paragraph> <paragraph num="(e)"> <text>American Association for Respiratory Care;</text> </paragraph> <paragraph num="(f)"> <text>American Nursing Association; or</text> </paragraph> <paragraph num="(g)"> <text>Board of Registered Polysomnographic Technologists</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Documentation of Continuing Education Hours.</text> <paragraph num="(1)"> <text>A polysomnographic technologist shall obtain the required documentation of continuing education attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The required documentation shall contain the:</text> <paragraph num="(a)"> <text>Program title;</text> </paragraph> <paragraph num="(b)"> <text>Sponsor's name;</text> </paragraph> <paragraph num="(c)"> <text>Polysomnographic technologist's name;</text> </paragraph> <paragraph num="(d)"> <text>Number of continuing education hours earned;</text> </paragraph> <paragraph num="(e)"> <text>Verification of successful completion by signature, stamp, or other official proof; and</text> </paragraph> <paragraph num="(f)"> <text>Date of the continuing education activity.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Fees."> <paragraph num="A."> <text>The following fees are applicable to polysomnographic technologists:</text> <paragraph num="(1)"> <text>Initial licensure application fee — $200;</text> </paragraph> <paragraph num="(2)"> <text>License renewal fees:</text> <paragraph num="(a)"> <text>License renewal fee — $150; and</text> </paragraph> <paragraph num="(b)"> <text>Maryland Health Care Commission (MHCC) fee — As determined by MHCC in accordance with COMAR 10.25.02;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reinstatement fee — $200; and</text> </paragraph> <paragraph num="(4)"> <text>Written verification of licensure fee — $25.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fees paid to the Board are non-refundable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Prohibited Conduct."> <paragraph num="A."> <text>Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, and in accordance with COMAR 10.32.02, a disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee:</text> <paragraph num="(1)"> <text>Fraudulently, or deceptively obtains or attempts to obtain a license for the applicant or licensee, or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of unprofessional or immoral conduct in the practice of polysomnography;</text> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(6)"> <text>Is habitually intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully makes or files a false report or record in the practice of polysomnography;</text> </paragraph> <paragraph num="(11)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report;</text> </paragraph> <paragraph num="(12)"> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="(13)"> <text>Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any individual for bringing or referring a patient, or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly makes a misrepresentation while practicing polysomnography;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly practices polysomnography with an unauthorized individual, or aids an unauthorized individual in the practice of polysomnography;</text> </paragraph> <paragraph num="(16)"> <text>Knowingly delegates a polysomnographic duty to an unlicensed individual;</text> </paragraph> <paragraph num="(17)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(18)"> <text>Is disciplined by a licensing or disciplinary authority, is convicted or disciplined by a court of any state or country, or is disciplined by any branch of the United States uniformed services or the U.S. Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board's disciplinary statutes;</text> </paragraph> <paragraph num="(19)"> <text>Fails to meet appropriate standards for the delivery of polysomnographic services performed in a hospital sleep laboratory or a stand-alone sleep center;</text> </paragraph> <paragraph num="(20)"> <text>Knowingly submits false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(21)"> <text>Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes and has:</text> <paragraph num="(a)"> <text>Surrendered the license, if any, issued by the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license, if any, issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(23)"> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(24)"> <text>Practices or attempts to practice beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(25)"> <text>Is convicted of, or pleads guilty or nolo contendere to, a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(26)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(27)"> <text>Practices or attempts to practice a polysomnography procedure or uses or attempts to use polysomnography equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; or</text> </paragraph> <paragraph num="(28)"> <text>Fails to cooperate with a lawful investigation conducted by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Crimes of Moral Turpitude.</text> <paragraph num="(1)"> <text>Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5C-17(c), Annotated Code of Maryland, shall be held in accordance with COMAR 10.32.02.07.</text> </paragraph> <paragraph num="(2)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, a disciplinary panel shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(3)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the disciplinary panel shall order the revocation of a license on the certification by the Office of the Attorney General.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Required Reports."> <text>A reporting entity, as defined in COMAR 10.32.22.02, shall file all required reports in accordance with Health Occupations Article, §14-5C-18, Annotated Code of Maryland, and COMAR 10.32.22.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Penalties, Fines, and Sanctions."> <paragraph num="A."> <text>An individual who violates any provision of Heath Occupations Article, Title 14, Subtitle 5C, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5C, Annotated Code of Maryland, or any regulation in this chapter, is subject to a civil fine of not more than $5,000 to be levied by the Board or a disciplinary panel.</text> </paragraph> <paragraph num="C."> <text>The Board shall pay any penalty collected under §A or B of this regulation into the Board of Physicians Fund.</text> </paragraph> <paragraph num="D."> <text>Employment of Unlicensed Polysomnography Practitioner.</text> <paragraph num="(1)"> <text>A person who violates Health Occupations Article, §14-5C-22.1, Annotated Code of Maryland, is subject to a civil fine of not more than $5,000 to be levied by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall pay any fine collected under §D of this regulation into the State’s General Fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may impose a fine up to $1,000 for a reporting entity, as defined in COMAR 10.32.22.02, that fails to make a report to the Board required by COMAR 10.32.22.</text> </paragraph> <paragraph num="F."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections F and G of this regulation and Regulation .13 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §G of this regulation, for violations of the sections of the Maryland Polysomnography Act listed in the sanctioning guidelines, a disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The disciplinary panel may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .13 of this chapter, in order to resolve a pending disciplinary action, the disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by the disciplinary panel, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If the disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .13 of this chapter, the disciplinary panel shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §G(4)—(5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the disciplinary panel or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the disciplinary panel or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .13 of this chapter is not a ground for any hearing or appeal of a disciplinary panel action.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Offenses Related to Continuing Education Requirements.</text> <paragraph num="(1)"> <text>If a licensee has submitted an application claiming the completion of continuing education credits and the licensee fails to document the completion of such continuing education credits when audited by the Board, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(a)"> <text>Health Occupations Article, §14-5C-17(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, §14-5C-17(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Health Occupations Article, §14-5C-17(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5C-17, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Payment of Fines Imposed by the Board or a Disciplinary Panel.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed pursuant to this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the State Department of Budget and Management to institute and maintain proceedings to ensure an individual’s prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Sanctioning Guidelines for Polysomnographic Technologists."> <paragraph num="A."> <text>A. Subject to provisions of Regulation .12F and G of this chapter, a disciplinary panel may impose sanctions as outlined in §B of this regulation on polysomnographic technologists for violations of Health Occupations Article, §14-5C-17(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-221, 1-606, 14-205, and 14-5C-01—14-5C-23, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 1, 2008 (35:24 Md. R. 2078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective October 1, 2009 (36:17 Md. R. 1311); amended permanently effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E, F adopted effective May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 15, 2016 (43:16 Md. R. 900); September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 22, 2014 (41:25 Md. R. 1485); September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C repealed effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended as an emergency provision effective October 1, 2009 (36:17 Md. R. 1311); amended permanently effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective August 15, 2016 (43:16 Md. R. 900); January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective May 11, 2015 (42:9 Md. R. 647); September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective May 11, 2015 (42:9 Md. R. 647); September 29, 2025 (52:19 Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D—H adopted effective July 22, 2013 (40:14 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective July 22, 2013 (40:14 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> </annotations> </chapter> <chapter num="07" heading="Unlicensed Medical Practitioners" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: February 11, 1985 (12:3 Md. R. 245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07 and .08 repealed effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective September 11, 1995 (22:18 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective April 23, 2018 (45:8 Md. R. 422)</annotation> </annotations> </chapter> <chapter num="08" heading="Licensure of Athletic Trainers"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of athletic training including “dry needling” within the practice of athletic training.</text> </paragraph> <paragraph num="B."> <text>This chapter does not prohibit an athletic training student who is enrolled in an accredited athletic training educational program from performing without pay any of the procedures described in this chapter as part of that program’s athletic training clinical curriculum.</text> </paragraph> <paragraph num="C."> <text>This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>This chapter does not prohibit an individual employed by the federal government as an athletic trainer from practicing within the scope of that employment.</text> </paragraph> <paragraph num="E."> <text>This chapter does not apply to an individual employed by or under contract with an entity located in another state who represents that entity:</text> <paragraph num="(1)"> <text>At an athletic event in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>For a period not exceeding 45 days within a calendar year; and</text> </paragraph> <paragraph num="(3)"> <text>By providing athletic training services to individuals representing the entity at the event.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited athletic training educational program” means an athletic training educational program that:</text> <paragraph num="(a)"> <text>Awards either a bachelor’s or master’s degree in athletic training; and</text> </paragraph> <paragraph num="(b)"> <text>Is accredited by the Commission on Accreditation of Athletic Training Education or its successor.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Alternate supervising physician” means one or more physicians designated by the supervising physician to provide supervision of an athletic trainer:</text> <paragraph num="(a)"> <text>During the absence of the supervising physician; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with the evaluation and treatment protocol on file with the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Athlete” means an individual who participates in an athletic activity.</text> </paragraph> <paragraph num="(4)"> <text>“Athletic activity” means an exercise, recreation, sport, competition, or game that:</text> <paragraph num="(a)"> <text>Requires physical strength, range of motion, flexibility, control, speed, stamina, or agility; and</text> </paragraph> <paragraph num="(b)"> <text>Is associated with a setting as defined under this section, an educational institution or a professional, amateur, or recreational sports club or athletic organization.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Athletic injury” means an injury that affects an athlete’s participation or performance in an athletic activity.</text> </paragraph> <paragraph num="(6)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(7)"> <text>“Certifying board” means the Board of Certification, Inc., or its successor.</text> </paragraph> <paragraph num="(8)"> <text>“Committee” means the Athletic Trainer Advisory Committee of the Board.</text> </paragraph> <paragraph num="(9)"> <text>“Dry needling” means an intramuscular therapy that:</text> <paragraph num="(a)"> <text>Involves the insertion of one or more solid needles into the muscle and related tissues to effect change in the muscle and related tissues;</text> </paragraph> <paragraph num="(b)"> <text>Requires ongoing evaluation, assessment, and reevaluation of an impairment;</text> </paragraph> <paragraph num="(c)"> <text>Is used only in parts of the body with neuromuscular or musculoskeletal links to an impairment; and</text> </paragraph> <paragraph num="(d)"> <text>Is not performed for:</text> <paragraph num="(i)"> <text>The purpose of acupuncture as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Any purpose outside of the scope of practice of athletic trainers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Evaluation and treatment protocol” means a document that is executed by a physician and an athletic trainer that meets the requirements in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Immediately available instruction” means instruction provided by the supervising physician to the athletic trainer in person, by telephone, or by other electronic means.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed athletic trainer” means an individual licensed by the Board to practice athletic training.</text> </paragraph> <paragraph num="(13)"> <text>“Licensed health care practitioner” means an individual licensed, certified, or otherwise authorized to practice a health occupation under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Nonsupervising physician” means a physician licensed by the Board who is not the supervising physician of the athletic trainer.</text> </paragraph> <paragraph num="(15)"> <text>“Outside referral” means a request for treatment from a nonsupervising physician or licensed health care practitioner.</text> </paragraph> <paragraph num="(16)"> <text>“Physician” means an individual licensed to practice medicine in Maryland under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>Practice Athletic Training.</text> <paragraph num="(a)"> <text>“Practice athletic training” means application of the following principles and methods for managing athletic injuries for athletes in good overall health under the supervision of a licensed physician:</text> <paragraph num="(i)"> <text>Prevention;</text> </paragraph> <paragraph num="(ii)"> <text>Clinical evaluation and assessment;</text> </paragraph> <paragraph num="(iii)"> <text>Immediate care; and</text> </paragraph> <paragraph num="(iv)"> <text>Treatment, rehabilitation, and reconditioning.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice athletic training” includes:</text> <paragraph num="(i)"> <text>Organization and administration of an athletic training program; and</text> </paragraph> <paragraph num="(ii)"> <text>Instruction to coaches, athletes, parents, medical personnel, and community members regarding the care and prevention of athletic injuries.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Practice athletic training” does not include any of the following:</text> <paragraph num="(i)"> <text>The practice of chiropractic, including adjustments, manipulation, or high-velocity mobilizations of the spine or extremities;</text> </paragraph> <paragraph num="(ii)"> <text>The practice of massage therapy;</text> </paragraph> <paragraph num="(iii)"> <text>The practice of medicine;</text> </paragraph> <paragraph num="(iv)"> <text>The practice of occupational therapy;</text> </paragraph> <paragraph num="(v)"> <text>The practice of physical therapy;</text> </paragraph> <paragraph num="(vi)"> <text>The practice of podiatry;</text> </paragraph> <paragraph num="(vii)"> <text>The reconditioning of systemic neurologic injuries, conditions, or disease; or</text> </paragraph> <paragraph num="(viii)"> <text>Except for the conditioning of an athlete under the supervision of a treating physician, the treatment, rehabilitation, or reconditioning of nonathletic injuries or disease.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Setting” means a:</text> <paragraph num="(a)"> <text>Location where an athletic activity, as defined in §B(4) of this regulation, is being held;</text> </paragraph> <paragraph num="(b)"> <text>Health or fitness club;</text> </paragraph> <paragraph num="(c)"> <text>Clinic or hospital;</text> </paragraph> <paragraph num="(d)"> <text>Corporation; or</text> </paragraph> <paragraph num="(e)"> <text>Government agency.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Supervising physician” means a physician who has been approved by the Board to supervise one or more athletic trainers.</text> </paragraph> <paragraph num="(20)"> <text>“Supervision” means the responsibility of a physician to provide ongoing and immediately available instruction, in person, by telephone, or by other electronic means, that is adequate to ensure the safety and welfare of a patient and is appropriate to the setting.</text> </paragraph> <paragraph num="(21)"> <text>“Supervision mechanism” means continuous availability to the athletic trainer of a supervising physician by one or more of the following means:</text> <paragraph num="(a)"> <text>On-site supervision;</text> </paragraph> <paragraph num="(b)"> <text>Written instructions;</text> </paragraph> <paragraph num="(c)"> <text>Electronic means;</text> </paragraph> <paragraph num="(d)"> <text>Verbal orders; and</text> </paragraph> <paragraph num="(e)"> <text>Designation of an alternate supervising physician.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Therapeutic Modalities.</text> <paragraph num="(a)"> <text>“Therapeutic modalities” means a variety of physical agents used to treat athletic injuries in an effort to decrease pain, reduce inflammation, decrease swelling, decrease muscle spasm, and provide a proper environment for the healing process to take place.</text> </paragraph> <paragraph num="(b)"> <text>“Therapeutic modalities” does not include the use of a prescription or nonprescription drug.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Committee."> <paragraph num="A."> <text>The Board shall establish a committee composed of the following individuals:</text> <paragraph num="(1)"> <text>Three licensed physicians meeting the following criteria:</text> <paragraph num="(a)"> <text>At least one physician shall be a specialist in orthopedic or sports medicine; and</text> </paragraph> <paragraph num="(b)"> <text>At least two of the physicians shall currently be or in the past have been partnered with or directed an athletic trainer;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Three athletic trainers who meet the following criteria:</text> <paragraph num="(a)"> <text>Have at least 5 years of clinical experience as an athletic trainer;</text> </paragraph> <paragraph num="(b)"> <text>If appointed or serving before October 1, 2011, be certified by the certifying board; and</text> </paragraph> <paragraph num="(c)"> <text>If appointed or serving on or after October 1, 2011, be licensed as an athletic trainer;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One licensed chiropractor with sports medicine experience;</text> </paragraph> <paragraph num="(4)"> <text>One licensed physical therapist;</text> </paragraph> <paragraph num="(5)"> <text>One licensed occupational therapist; and</text> </paragraph> <paragraph num="(6)"> <text>Two consumers meeting the criteria specified in Health Occupations Article, §14-5D-05(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Selection of Athletic Trainers. The Board may appoint the athletic trainer members from a list of qualified individuals submitted to the Board by the Maryland Athletic Trainers Association, Inc.</text> </paragraph> <paragraph num="C."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second term, but the individual may not serve more than two full, consecutive terms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs, the Board shall appoint a new member to serve, as provided in this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall serve only for the remainder of the term, unless reappointed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Chair.</text> <paragraph num="(1)"> <text>The Committee shall elect a chair from among its members.</text> </paragraph> <paragraph num="(2)"> <text>The chair shall serve for 2 years.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Make recommendations to the Board regarding:</text> <paragraph num="(a)"> <text>Regulations governing athletic trainers;</text> </paragraph> <paragraph num="(b)"> <text>Continuing education requirements for license renewal; and</text> </paragraph> <paragraph num="(c)"> <text>The practice of athletic training;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Develop and recommend to the Board an evaluation and treatment protocol for use by an athletic trainer and the physician with whom the athletic trainer practices;</text> </paragraph> <paragraph num="(3)"> <text>Upon request of the Board, provide advice and recommendations to the Board on individual evaluation and treatment protocols; and</text> </paragraph> <paragraph num="(4)"> <text>Keep a record of the Committee’s proceedings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Licensure as an Athletic Trainer."> <paragraph num="A."> <text>An applicant for licensure as an athletic trainer shall:</text> <paragraph num="(1)"> <text>Complete an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay an application fee as specified in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submit all documentation which the Board requires to evaluate the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To qualify, an applicant shall meet all of the following requirements:</text> <paragraph num="(1)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate oral and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; or</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Meet the following education requirements:</text> <paragraph num="(a)"> <text>A bachelor’s or master’s degree from an accredited athletic training educational program; or</text> </paragraph> <paragraph num="(b)"> <text>Exemption from the education requirement because the applicant:</text> <paragraph num="(i)"> <text>Was certified by the certifying board on or before October 1, 2012; and</text> </paragraph> <paragraph num="(ii)"> <text>Is in good standing with the certifying board at the time of the application;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Has passed the certification examination of the certifying board; and</text> </paragraph> <paragraph num="(6)"> <text>Has been certified and maintains current certification from the certifying board at the time of application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of Practice."> <paragraph num="A."> <text>The scope of practice of an athletic trainer in the domain of injury prevention and wellness protection includes the following:</text> <paragraph num="(1)"> <text>Minimization of risk of injury of athletes through awareness and education;</text> </paragraph> <paragraph num="(2)"> <text>Monitoring of environmental conditions to facilitate individual and group safety of athletes;</text> </paragraph> <paragraph num="(3)"> <text>Maintenance or enhancement of physical conditioning of athletes; and</text> </paragraph> <paragraph num="(4)"> <text>Promotion of a healthy lifestyle of athletes using appropriate education and communication strategies to enhance wellness and minimize the risk of injury and illness.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The scope of practice of an athletic trainer in the domain of clinical evaluation and assessment includes the following with respect to athletes:</text> <paragraph num="(1)"> <text>Obtaining athlete’s health history through observation, interview, and records review;</text> </paragraph> <paragraph num="(2)"> <text>Examining athlete’s body to assess the type and extent of the athletic injury;</text> </paragraph> <paragraph num="(3)"> <text>Formulating a clinical assessment; and</text> </paragraph> <paragraph num="(4)"> <text>Communicating information about the athletic injury to appropriate persons including the athlete.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The scope of practice of an athletic trainer in the domain of immediate and emergency care includes the following with respect to athletes:</text> <paragraph num="(1)"> <text>Immediate and emergency procedures including:</text> <paragraph num="(a)"> <text>CPR;</text> </paragraph> <paragraph num="(b)"> <text>Applying ice;</text> </paragraph> <paragraph num="(c)"> <text>Splinting;</text> </paragraph> <paragraph num="(d)"> <text>Elevation;</text> </paragraph> <paragraph num="(e)"> <text>Pressure;</text> </paragraph> <paragraph num="(f)"> <text>Bandaging for bleeding;</text> </paragraph> <paragraph num="(g)"> <text>Proper immobilization of spine or other body parts; and</text> </paragraph> <paragraph num="(h)"> <text>Dry needling; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Making appropriate referrals so that the athlete will obtain appropriate follow-up.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The scope of practice of an athletic trainer in the domain of treatment and rehabilitation includes the following activities, performed in an approved setting, with respect to athletes with athletic injuries:</text> <paragraph num="(1)"> <text>Administering therapeutic and conditioning exercises as identified by the evaluation and treatment protocols of the supervising physician;</text> </paragraph> <paragraph num="(2)"> <text>Administering therapeutic modalities as identified by the evaluation and treatment protocols of the supervising physician;</text> </paragraph> <paragraph num="(3)"> <text>Applying braces, splints, or other assistive devices as identified by the evaluation and treatment protocols of the supervising physician;</text> </paragraph> <paragraph num="(4)"> <text>Reassessing the status of injuries, illnesses, or conditions using appropriate techniques and documentation strategies to:</text> <paragraph num="(a)"> <text>Determine appropriate treatment, rehabilitation, or reconditioning for injuries; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate readiness to return to desired level of activity with respect to injuries, illnesses, or conditions; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Administering dry needling therapy under the direction and guidance of a supervising physician who has training and experience in dry needling.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The scope of practice of an athletic trainer in the domain of organization and management includes the following activities:</text> <paragraph num="(1)"> <text>Maintenance of medical records with respect to all athletes who receive emergency care, assessment, or treatment;</text> </paragraph> <paragraph num="(2)"> <text>Planning and organization of an athletic training program; and</text> </paragraph> <paragraph num="(3)"> <text>Instructing others in prevention of and care for athletic injuries.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The athletic trainer may accept an outside referral from a nonsupervising physician or licensed health care practitioner if:</text> <paragraph num="(1)"> <text>The supervising physician specifies in the evaluation and treatment protocol that the athletic trainer may accept referrals from nonsupervising physicians or other licensed health care practitioners;</text> </paragraph> <paragraph num="(2)"> <text>The nonsupervising physician or licensed health care practitioner has seen the athlete and has written an order for the care; and</text> </paragraph> <paragraph num="(3)"> <text>The duties are:</text> <paragraph num="(a)"> <text>Within the scope of practice of an athletic trainer; and</text> </paragraph> <paragraph num="(b)"> <text>Among the duties delegated in the evaluation and treatment protocol.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Evaluation and Treatment Protocol."> <paragraph num="A."> <text>Contents. The evaluation and treatment protocol shall include the following:</text> <paragraph num="(1)"> <text>Identification, licensure information, and signature of the:</text> <paragraph num="(a)"> <text>Licensed athletic trainer; and</text> </paragraph> <paragraph num="(b)"> <text>Licensed supervising physician;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Information about where the athletic trainer practices, including:</text> <paragraph num="(a)"> <text>Addresses of the primary employer and supervising physician; and</text> </paragraph> <paragraph num="(b)"> <text>Identification of the settings where the athletic trainer may practice;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Description of the supervision mechanism that applies to each setting;</text> </paragraph> <paragraph num="(4)"> <text>Description of the delegated processes and procedures that the athletic trainer may use in each of the following areas:</text> <paragraph num="(a)"> <text>Injury or illness prevention and wellness;</text> </paragraph> <paragraph num="(b)"> <text>Clinical evaluation and assessment;</text> </paragraph> <paragraph num="(c)"> <text>Immediate and emergency care;</text> </paragraph> <paragraph num="(d)"> <text>Treatment, rehabilitation, and reconditioning; and</text> </paragraph> <paragraph num="(e)"> <text>Organizational and professional well-being;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Descriptions of tasks which the athletic trainer may not perform;</text> </paragraph> <paragraph num="(6)"> <text>Description of specialized tasks the supervising physician is delegating to the athletic trainer to perform with documentation of competencies, certification, credentials, or any other requirements established by the Board to support the delegation of the specialized tasks;</text> </paragraph> <paragraph num="(7)"> <text>A statement of whether or not the supervising physician will permit the athletic trainer to accept outside referrals meeting the requirements stated in Regulation .05F of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>If applicable, the name and other relevant information about an alternate supervising physician; and</text> </paragraph> <paragraph num="(9)"> <text>An attestation that states that the supervising physician will be responsible for providing ongoing and immediately available instruction that is adequate to ensure the safety and welfare of a patient and is appropriate to the setting.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Process and Approval.</text> <paragraph num="(1)"> <text>A licensed athletic trainer shall:</text> <paragraph num="(a)"> <text>Submit an evaluation and treatment protocol on a form approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the fee as specified in Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed athletic trainer may practice athletic training after receiving written approval from the Committee.</text> </paragraph> <paragraph num="(3)"> <text>The Committee shall conditionally approve an evaluation and treatment protocol if:</text> <paragraph num="(a)"> <text>The evaluation and treatment protocol does not include specialized tasks; or</text> </paragraph> <paragraph num="(b)"> <text>The evaluation and treatment protocol includes specialized tasks that have been previously approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an evaluation and treatment protocol includes a specialized task that has not been previously approved by the Board, the athletic trainer may perform the specialized task only after receiving written approval from the Board.</text> </paragraph> <paragraph num="(5)"> <text>After consideration by the Committee, the Board shall either:</text> <paragraph num="(a)"> <text>Approve the evaluation and treatment protocol and any specialized tasks; or</text> </paragraph> <paragraph num="(b)"> <text>Disapprove the evaluation and treatment protocol or a specialized task if the Board determines that the evaluation and treatment protocol or specialized task does not meet the requirements in Health Occupations Article, §14-5D-11.3(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the Board disapproves an evaluation and treatment protocol or a specialized task included in an evaluation and treatment protocol, the Board shall send written notice of the disapproval to the:</text> <paragraph num="(a)"> <text>Primary supervising physician; and</text> </paragraph> <paragraph num="(b)"> <text>Athletic trainer.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>An athletic trainer who receives notice of a disapproval of an evaluation and treatment protocol from the Board shall immediately cease:</text> <paragraph num="(a)"> <text>Practicing under the evaluation and treatment protocol; or</text> </paragraph> <paragraph num="(b)"> <text>Performing the specialized task.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>An individual member of the Board is not civilly liable for any act or omission relating to the approval, modification, or disapproval of an evaluation and treatment protocol.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Termination of Evaluation and Treatment Protocol.</text> <paragraph num="(1)"> <text>If the athletic trainer or the supervising physician terminates the evaluation and treatment protocol, the athletic trainer shall cease practicing until another evaluation and treatment protocol is approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The supervising physician shall report the termination of an evaluation and treatment protocol for any reason to the Board within 10 days of the termination and provide the following information:</text> <paragraph num="(a)"> <text>Name and license number of supervising physician and athletic trainer; and</text> </paragraph> <paragraph num="(b)"> <text>Reason for termination, including a description of conduct or incident that resulted in the termination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Emergency Evaluation and Treatment Protocol. In the event of a sudden departure, incapacity, or death of a supervising physician, a designated alternate may assume the role of the supervising physician by submitting a new evaluation and treatment protocol to the Board within 15 days.</text> </paragraph> <paragraph num="E."> <text>Dry Needling Protocol.</text> <paragraph num="(1)"> <text>The practice of dry needling by a licensed athletic trainer shall require approval from the Board as a specialized task.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall issue approval to perform dry needling to a licensed athletic trainer who provides proof of completion of at least 80 hours of instruction in a continuing education course approved by:</text> <paragraph num="(a)"> <text>The National Athletic Trainers’ Association;</text> </paragraph> <paragraph num="(b)"> <text>The Board of Certification for the Athletic Trainer; or</text> </paragraph> <paragraph num="(c)"> <text>The United States Armed Forces.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Course Requirements.</text> <paragraph num="(a)"> <text>Of the 80 hours of instruction required under §E(2) of this regulation, at least 40 hours of instruction shall be in the following content areas:</text> <paragraph num="(i)"> <text>Theory and application of dry needling;</text> </paragraph> <paragraph num="(ii)"> <text>Dry needling technique, including spine and extremities;</text> </paragraph> <paragraph num="(iii)"> <text>Dry needling indications and contraindications;</text> </paragraph> <paragraph num="(iv)"> <text>Infection control, the Occupational Safety and Health Administration’s Bloodborne Pathogen Protocol, and safe handling of needles;</text> </paragraph> <paragraph num="(v)"> <text>Emergency preparedness and response procedures related to complications associated with dry needling; and</text> </paragraph> <paragraph num="(vi)"> <text>Appropriate documentation of dry needling.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Of the 80 hours of instruction required under §E(2) of this regulation, at least 40 hours shall be practical, hands-on instruction in the application and technique of dry needling that is completed under the guidance of a licensed health care practitioner who:</text> <paragraph num="(i)"> <text>Is approved to perform dry needling; and</text> </paragraph> <paragraph num="(ii)"> <text>Has practiced dry needling for at least 5 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The instruction required under §E of this regulation shall include an assessment of the licensed athletic trainer’s competency to perform dry needling that is performed by the instructor of the approved course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal, Reinstatement, Continuing Education, and Change in Name or Address."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has been licensed by the Board as an athletic trainer may renew the license every 2 years on the date specified by the Board by:</text> <paragraph num="(a)"> <text>Completing a renewal application on a form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee specified in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to the completion of at least 50 hours of approved continuing education credits, earned during the 2-year period preceding the expiration of the license for athletic training, in accordance with the requirements specified in §C of this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>Meeting any other requirement established by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The continuing education requirement applies to all renewal applications after the first renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement. The Board shall reinstate the license of an athletic trainer if the athletic trainer:</text> <paragraph num="(1)"> <text>Completes a reinstatement application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays the required reinstatement fee and any other fees specified in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Documents evidence of at least 50 hours of approved continuing education credits during the 2-year period preceding the date of the submission of the application for reinstatement;</text> </paragraph> <paragraph num="(4)"> <text>Meets any additional requirements set by the Board for reinstatement of a license; and</text> </paragraph> <paragraph num="(5)"> <text>Is currently registered with the certifying board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>The following activities are approved continuing education experiences:</text> <paragraph num="(a)"> <text>Programs presented by providers approved by the certifying board;</text> </paragraph> <paragraph num="(b)"> <text>Professional development activities approved by the certifying board; and</text> </paragraph> <paragraph num="(c)"> <text>Courses offered for undergraduate or graduate degree credit by colleges or universities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation.</text> <paragraph num="(a)"> <text>An athletic trainer shall obtain documentation of completion of continuing education and retain the documentation for 4 years.</text> </paragraph> <paragraph num="(b)"> <text>The documentation for a program provided by a provider approved by the certifying board shall contain, at a minimum, the following information:</text> <paragraph num="(i)"> <text>Program title;</text> </paragraph> <paragraph num="(ii)"> <text>Sponsor’s name;</text> </paragraph> <paragraph num="(iii)"> <text>Athletic trainer’s name;</text> </paragraph> <paragraph num="(iv)"> <text>Inclusive date or dates and location of the program;</text> </paragraph> <paragraph num="(v)"> <text>Number of continuing education hours earned; and</text> </paragraph> <paragraph num="(vi)"> <text>Documented verification that the athletic trainer attended the program by stamp, signature, printout, or other official proof.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation for professional development activities shall be as specified by the certifying board.</text> </paragraph> <paragraph num="(d)"> <text>Documentation of credits earned through college or university courses shall be an official transcript from the college or university.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Proof of maintenance of certification by the certifying board may be used to document compliance with the continuing education requirement.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Change in Name or Address.</text> <paragraph num="(1)"> <text>A licensee shall notify the Board in writing of a change in name or address within 60 days after the change.</text> </paragraph> <paragraph num="(2)"> <text>Licensees who fail to notify the Board of name or address changes as required by §D(1) of this regulation are subject to an administrative penalty of $100.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Fees."> <text>The following fees are applicable to athletic trainers.</text> <paragraph num="A."> <text>Initial licensure fee — $200;</text> </paragraph> <paragraph num="B."> <text>License renewal fees:</text> <paragraph num="(1)"> <text>License renewal fee — $135; and</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee — as determined by MHCC under COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement fee — $200;</text> </paragraph> <paragraph num="D."> <text>Evaluation and treatment protocol — $100;</text> </paragraph> <paragraph num="E."> <text>Written verification fee — $25; and</text> </paragraph> <paragraph num="F."> <text>Replacement of license fee — $25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Prohibited Conduct."> <paragraph num="A."> <text>Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, the Board may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant, for the licensee, or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of unprofessional or immoral conduct in the practice of athletic training;</text> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(6)"> <text>Habitually is intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using:</text> <paragraph num="(i)"> <text>Any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Any other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully makes or files a false report or record in the practice of athletic training;</text> </paragraph> <paragraph num="(11)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="(12)"> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="(13)"> <text>Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly makes a misrepresentation while practicing athletic training;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly practices athletic training with an unauthorized individual or aids an unauthorized individual in the practice of athletic trainer services;</text> </paragraph> <paragraph num="(16)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(17)"> <text>Is disciplined by a licensing, certifying, or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the Veterans Administration for an act that would be grounds for disciplinary action under Health Occupations Article, §15-5D-14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(18)"> <text>Fails to meet appropriate standards for delivery of athletic training services;</text> </paragraph> <paragraph num="(19)"> <text>Knowingly submits false statements to collect fees for which services have not been provided;</text> </paragraph> <paragraph num="(20)"> <text>Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes and the licensed individual:</text> <paragraph num="(a)"> <text>Surrendered the license issued by the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(22)"> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(23)"> <text>Practices or attempts to practice beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(24)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(25)"> <text>Practices or attempts to practice an athletic training procedure or uses or attempts to use athletic training equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment;</text> </paragraph> <paragraph num="(26)"> <text>Fails to cooperate with a lawful investigation conducted by the Board;</text> </paragraph> <paragraph num="(27)"> <text>Fails to practice under the supervision of a physician or violates the approved evaluation and treatment protocol;</text> </paragraph> <paragraph num="(28)"> <text>Violates an order of the Board, including any condition of probation; or</text> </paragraph> <paragraph num="(29)"> <text>Performs dry needling without the approval of the Board issued under Regulation .06E of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Crimes of Moral Turpitude.</text> <paragraph num="(1)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Investigations, Hearings, and Appeals."> <paragraph num="A."> <text>Complaints alleging prohibited conduct shall be referred to the Board to be investigated according to the Board’s procedures.</text> </paragraph> <paragraph num="B."> <text>A hearing on charges issued under Regulation .09A of this chapter or Health Occupations Article, §14-5D-14(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §§14-405 and 14-5D-15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5D-14(b), Annotated Code of Maryland, or Regulation .09B of this chapter shall be held in accordance with COMAR 10.32.02.08.</text> </paragraph> <paragraph num="D."> <text>All other hearings shall be held in accordance with the Administrative Procedure Act.</text> </paragraph> <paragraph num="E."> <text>Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5D-15, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Fines, Penalties, and Sanctioning Guidelines."> <paragraph num="A."> <text>An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5D, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000, or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a civil fine of not more than $5,000 on an individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5D, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Board shall deposit a penalty collected under §B of this regulation into the Board of Physicians fund.</text> </paragraph> <paragraph num="D."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections D and E of this regulation and Regulation .12 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §E of this regulation, for violations of the sections of the Maryland Athletic Trainers Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §D(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(d)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction.</text> </paragraph> <paragraph num="(e)"> <text>The addition of a fine does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .12 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §E(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .12 of this chapter, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §E(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .12 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Offenses Related to Continuing Medical Education Credits.</text> <paragraph num="(1)"> <text>First Offense of Failure to Document Credits.</text> <paragraph num="(a)"> <text>Except as provided in §F(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5D-12, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5D-14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Section F(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5D-14(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5D-14(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5D-14(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5D-14, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees Previously Disciplined Under §I(1) or (2) of this regulation.</text> <paragraph num="(a)"> <text>If a licensee has been previously fined or otherwise disciplined under §F(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5D-14(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5D-14(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5D-14(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5D-14, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(c)"> <text>The Board may not apply the sanction described in §F(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall pay all monies collected pursuant to this section into the Board of Physicians Fund.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Sanctioning Guidelines for Athletic Trainers."> <paragraph num="A."> <text>Subject to provisions of Regulation .11D—E of this chapter, the Board may impose sanctions as outlined in §B of this regulation on athletic trainers for violations of Health Occupations Article, §14-5D-14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-606, 14-205 and 14-5D-01—14-5D-20, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 22, 2013 (40:14 Md. R. 1176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C, D amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> </annotations> </chapter> <chapter num="09" heading="Delegation and Assignment of Performance of Cosmetic Medical Procedures and Use of Cosmetic Medical Devices"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the performance, delegation, assignment, and supervision of cosmetic medical procedures, and the use of cosmetic medical devices by a physician or under a physician's direction.</text> </paragraph> <paragraph num="B."> <text>This chapter does not govern use of medical procedures or medical devices for the purpose of treating a disease.</text> </paragraph> <paragraph num="C."> <text>This chapter does not endorse or certify the safety of any cosmetic medical device or cosmetic medical procedure.</text> </paragraph> <paragraph num="D."> <text>This chapter does not authorize the delegation of any duties to any person who is not licensed under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ACCME” means the Accreditation Council on Continuing Medical Education.</text> </paragraph> <paragraph num="(2)"> <text>“ACGME” means the Accreditation Council for Graduate Medical Education.</text> </paragraph> <paragraph num="(3)"> <text>“AOA” means the American Osteopathic Association.</text> </paragraph> <paragraph num="(4)"> <text>Cosmetic Medical Device.</text> <paragraph num="(a)"> <text>“Cosmetic medical device” means a device that alters or damages living tissue.</text> </paragraph> <paragraph num="(b)"> <text>“Cosmetic medical device” includes any of the following items, when the item is used for cosmetic purposes:</text> <paragraph num="(i)"> <text>Laser;</text> </paragraph> <paragraph num="(ii)"> <text>Device emitting light or intense pulsed light;</text> </paragraph> <paragraph num="(iii)"> <text>Device emitting radio frequency, electric pulses, or sound waves; and</text> </paragraph> <paragraph num="(iv)"> <text>Devices used for the injection or insertion of foreign or natural substances into the skin, fat, facial tissue, muscle, or bone.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Cosmetic Medical Procedure.</text> <paragraph num="(a)"> <text>“Cosmetic medical procedure” means a procedure using a cosmetic medical device or medical product to improve an individual's appearance.</text> </paragraph> <paragraph num="(b)"> <text>“Cosmetic medical procedure” includes the following:</text> <paragraph num="(i)"> <text>Skin treatments using lasers;</text> </paragraph> <paragraph num="(ii)"> <text>Skin treatments using intense pulsed light;</text> </paragraph> <paragraph num="(iii)"> <text>Skin treatments using radio frequencies, microwave, or electric pulses;</text> </paragraph> <paragraph num="(iv)"> <text>Chemical peels that ablate living skin tissue;</text> </paragraph> <paragraph num="(v)"> <text>Skin treatments with phototherapy;</text> </paragraph> <paragraph num="(vi)"> <text>Dermabrasion;</text> </paragraph> <paragraph num="(vii)"> <text>Subcutaneous, intradermal, or intramuscular injections of medical products;</text> </paragraph> <paragraph num="(viii)"> <text>Treatments intended to remove or cause destruction of fat; and</text> </paragraph> <paragraph num="(ix)"> <text>Any treatment using a cosmetic medical device for the purpose of improving an individual's appearance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Delegate” means to entrust a duty to a physician assistant under Health Occupations Article, Title 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Delegation” means the entrusting of a duty by a physician to a physician assistant under Health Occupations Article, Title 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Dermabrasion” means an abrasive process to remove epidermis and superficial dermis, resulting in a smoothing of contour irregularities.</text> </paragraph> <paragraph num="(9)"> <text>“Direct supervision” means oversight exercised by a supervising physician who is:</text> <paragraph num="(a)"> <text>In the physical presence of a non-physician and a patient; and</text> </paragraph> <paragraph num="(b)"> <text>Instructing the non-physician in the performance of a cosmetic medical procedure, or observing the performance of a non-physician being trained in the procedure.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Immediately available supervision” means the responsibility of a licensed physician to provide necessary direction in person, by telephone, or by other electronic means.</text> </paragraph> <paragraph num="(11)"> <text>“Non-Physician” means an individual who:</text> <paragraph num="(a)"> <text>Meets the requirements of Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is not licensed in Maryland as a physician.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“On-site supervision” means oversight exercised by a supervising physician who is:</text> <paragraph num="(a)"> <text>Present at the site; and</text> </paragraph> <paragraph num="(b)"> <text>Able to respond in person during a delegated or assigned cosmetic medical procedure.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Physician assistant” means a physician assistant with a current certificate to practice in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Physician Qualifications."> <paragraph num="A."> <text>License. A physician shall obtain a license to practice medicine in Maryland before the physician may perform, delegate, assign, or supervise cosmetic medical procedures or the use of cosmetic medical devices.</text> </paragraph> <paragraph num="B."> <text>Education.</text> <paragraph num="(1)"> <text>A physician who performs, assigns, supervises, or delegates the performance of cosmetic medical procedures by a non-physician first shall obtain training in the indications for and performance of the cosmetic medical procedures and operation of any cosmetic medical device to be used.</text> </paragraph> <paragraph num="(2)"> <text>Training programs provided by a manufacturer or vendor of cosmetic medical devices or supplies may not be a physician's only education in the cosmetic medical procedures or the operation of the cosmetic medical devices to be used.</text> </paragraph> <paragraph num="(3)"> <text>ACCME or AOA approved continuing education, or completion of an ACGME or AOA accredited postgraduate program that includes training in the cosmetic medical procedure performed satisfies this requirement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications of Individual to Whom Acts May Be Delegated and Assigned."> <paragraph num="A."> <text>A cosmetic medical procedure may be delegated to a physician assistant or assigned to any other health care provider licensed under Health Occupations Article, Annotated Code of Maryland, whose licensing board has determined that the procedure falls within the provider's scope of practice.</text> </paragraph> <paragraph num="B."> <text>A physician may not permit any individual who performs cosmetic medical procedures delegated or assigned by that physician to operate a cosmetic medical device or perform a cosmetic medical procedure unless the individual has received:</text> <paragraph num="(1)"> <text>Training as described in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Any training required by that individual's health occupations board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physician Responsibilities."> <paragraph num="A."> <text>A physician shall:</text> <paragraph num="(1)"> <text>Develop and maintain at each site where the delegated, assigned, or supervised cosmetic medical procedures will be rendered written office protocols for each such cosmetic medical procedure;</text> </paragraph> <paragraph num="(2)"> <text>Personally perform the initial assessment of each patient;</text> </paragraph> <paragraph num="(3)"> <text>Prepare a written treatment plan for each patient, including diagnosis and planned course of treatment and specification of the device and device settings to be used;</text> </paragraph> <paragraph num="(4)"> <text>Obtain informed consent of the patient to be treated by a non-physician;</text> </paragraph> <paragraph num="(5)"> <text>Except as indicated in §B or C of this regulation, provide onsite supervision whenever a non-physician is performing cosmetic medical procedures or using cosmetic medical devices;</text> </paragraph> <paragraph num="(6)"> <text>Retain responsibility for any acts delegated to a non-physician; and</text> </paragraph> <paragraph num="(7)"> <text>Create and maintain medical records in a manner consistent with accepted medical practice and in compliance with Health-General Article, Title 4, Subtitles 3 and 4, Annotated Code of Maryland, and with Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d-2, as amended, and 45 CFR Parts 160 and 164, as amended).</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may approve a delegation agreement for a physician assistant that permits the physician to delegate performance of cosmetic medical procedures under immediately available supervision after the physician has evaluated the patient and developed a written treatment plan.</text> </paragraph> <paragraph num="C."> <text>A delegation agreement for a physician assistant that includes cosmetic medical procedures and is approved by the Board before May 2009, is not affected by this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Written Protocols."> <text>Written protocols for cosmetic medical procedures and equipment shall include the following:</text> <paragraph num="A."> <text>List of all equipment, including:</text> <paragraph num="(1)"> <text>Manufacturer's specifications;</text> </paragraph> <paragraph num="(2)"> <text>Operating instructions; and</text> </paragraph> <paragraph num="(3)"> <text>Maintenance log;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Documentation regarding initial and periodic training of all users of the equipment;</text> </paragraph> <paragraph num="C."> <text>Role of the physician for each procedure;</text> </paragraph> <paragraph num="D."> <text>Role of the non-physician for each procedure;</text> </paragraph> <paragraph num="E."> <text>Steps to address common complications and emergency situations; and</text> </paragraph> <paragraph num="F."> <text>Appropriate care and follow-up for the patient after the procedure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Training of Non-Physicians."> <paragraph num="A."> <text>The physician is responsible for assuring that any individual to whom the physician delegates or assigns the performance of a cosmetic medical procedure or the operation of a cosmetic medical device is properly trained. Training shall include both theoretical instruction and clinical instruction.</text> </paragraph> <paragraph num="B."> <text>Theoretical instruction shall include:</text> <paragraph num="(1)"> <text>Cosmetic-dermatological indications and contraindications for treatment;</text> </paragraph> <paragraph num="(2)"> <text>Identification of realistic and expected outcomes of each procedure;</text> </paragraph> <paragraph num="(3)"> <text>Selection, maintenance, and utilization of equipment;</text> </paragraph> <paragraph num="(4)"> <text>Appropriate technique for each procedure, including infection control and safety precautions;</text> </paragraph> <paragraph num="(5)"> <text>Pharmacological intervention specific to the procedure;</text> </paragraph> <paragraph num="(6)"> <text>Identification of complications and adverse reactions for each procedure;</text> </paragraph> <paragraph num="(7)"> <text>Emergency procedures to be used in the event of:</text> <paragraph num="(a)"> <text>Complications;</text> </paragraph> <paragraph num="(b)"> <text>Adverse reactions;</text> </paragraph> <paragraph num="(c)"> <text>Equipment malfunction; or</text> </paragraph> <paragraph num="(d)"> <text>Any other interruption of a procedure; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Appropriate documentation of the procedure in the patient's chart.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical instruction shall include:</text> <paragraph num="(1)"> <text>Observation of performance of the procedure or use of the device by an individual experienced in performing the procedure; and</text> </paragraph> <paragraph num="(2)"> <text>Performing the procedure or using the device under the direct supervision of the delegating physician who is present and observing the procedure a sufficient number of times to assure that the non-physician is competent to perform the procedure without direct supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Non-Physician's Responsibility."> <paragraph num="A."> <text>A physician who delegates or assigns a cosmetic medical procedure or the use of a cosmetic medical device to a non-physician or who supervises a non-physician performing these functions shall assure that the non-physician complies with this regulation.</text> </paragraph> <paragraph num="B."> <text>A non-physician may not use a cosmetic medical device or perform a cosmetic medical procedure unless the individual has received:</text> <paragraph num="(1)"> <text>The training described in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Any training required by that individual's health occupations board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A non-physician shall:</text> <paragraph num="(1)"> <text>Review and follow the written protocol with respect to a cosmetic medical procedure;</text> </paragraph> <paragraph num="(2)"> <text>Verify that the physician has assessed the patient and given written treatment instructions for the procedure;</text> </paragraph> <paragraph num="(3)"> <text>Discuss the procedure with the patient to ensure that the patient:</text> <paragraph num="(a)"> <text>Is aware that the treatment will be provided by a non-physician; and</text> </paragraph> <paragraph num="(b)"> <text>Has given consent in writing to treatment by a non-physician;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Notify the delegating physician about any adverse events or complications before the patient leaves the site;</text> </paragraph> <paragraph num="(5)"> <text>Document all relevant details of the procedure in the patient's chart, including any adverse events and complications; and</text> </paragraph> <paragraph num="(6)"> <text>Satisfy any requirements imposed by the licensing board of the non-physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Grounds for Discipline."> <paragraph num="A."> <text>Physician. A physician may be disciplined for any of the following:</text> <paragraph num="(1)"> <text>Delegating, assigning, or supervising a cosmetic medical procedure performed by an individual who is not a physician assistant or another licensed health care provider whose licensing board has determined that the procedure is within the scope of practice of the individual;</text> </paragraph> <paragraph num="(2)"> <text>Delegating cosmetic medical procedures to an individual who has not had:</text> <paragraph num="(a)"> <text>The training specified in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The training required by that individual's health occupations board; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Failure to adhere to any requirement of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Non-Physician. A non-physician who violates any provision of this chapter is guilty of the practice of medicine without a license and may be subject to a fine of not more than $50,000 under Health Occupations Article, §14-606, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Other Individual. An individual using a cosmetic medical device or performing a cosmetic medical procedure who is not a licensed physician and is not authorized to perform the cosmetic medical procedure under this chapter, or under regulations promulgated by another licensing board established by Health Occupations Article, Annotated Code of Maryland, is guilty of the practice of medicine without a license and may be subject to a fine of not more than $50,000 under Health Occupations Article, §14-606, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-205, 14-306, 14-404, 14-606, and 15-302, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 23, 2010 (37:17 Md. R. 1185)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 386); December 31, 2018 (45:26 Md. R. 1246)</annotation> </annotations> </chapter> <chapter num="10" heading="Licensure of Radiation Therapists, Radiographers, Nuclear Medicine Technologists, and Radiologist Assistants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of radiation therapy, radiography, nuclear medicine technology, and radiology assistance.</text> </paragraph> <paragraph num="B."> <text>This chapter does not prohibit:</text> <paragraph num="(1)"> <text>A radiation therapy, radiography, nuclear medicine technology, or radiology assistance student enrolled in an educational program from practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance in the educational program;</text> </paragraph> <paragraph num="(2)"> <text>An individual employed by the federal government as a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant from practicing within the scope of that employment; or</text> </paragraph> <paragraph num="(3)"> <text>An individual from practicing a health occupation that the individual is authorized to practice under the Health Occupations Article.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ARRT” means the American Registry of Radiologic Technologists.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Certification” means recognition of an individual who has satisfied certain standards required by a national certifying board.</text> </paragraph> <paragraph num="(4)"> <text>“Committee” means the Radiation Therapy, Radiography, Nuclear Medicine Technology, and Radiology Assistance Advisory Committee of the Board.</text> </paragraph> <paragraph num="(5)"> <text>“Computed tomography (CT)” means the use of a machine that produces ionizing radiation to obtain cross-sectional images.</text> </paragraph> <paragraph num="(6)"> <text>Direct Supervision.</text> <paragraph num="(a)"> <text>“Direct supervision” means supervision by a licensed physician who is:</text> <paragraph num="(i)"> <text>In the physical presence of the licensee and a patient; and</text> </paragraph> <paragraph num="(ii)"> <text>Observing and directing the licensee as the licensee performs a procedure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Direct supervision” includes, for purposes of meeting the examination eligibility requirements set out in Regulation .10B of this chapter, supervision by a:</text> <paragraph num="(i)"> <text>Licensed nuclear medicine technologist with the post-primary computed tomography (CT) credential;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed radiographer with the post-primary CT credential; or</text> </paragraph> <paragraph num="(iii)"> <text>Licensed radiologist or radiation oncologist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Hybrid nuclear medicine/CT device” means a machine that combines two distinct imaging modalities.</text> </paragraph> <paragraph num="(8)"> <text>“Immediately available direction” means the responsibility of a licensed physician to provide necessary direction for a licensee in person, by telephone, or by other electronic means if the licensee needs assistance with a procedure.</text> </paragraph> <paragraph num="(9)"> <text>“JRCNMT” means the Joint Review Committee on Educational Programs in Nuclear Medicine Technology.</text> </paragraph> <paragraph num="(10)"> <text>“Licensee” means an individual who is licensed to practice radiography, radiation therapy, nuclear medicine technology, or radiology assistance in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“NMTCB” means the Nuclear Medicine Technology Certification Board.</text> </paragraph> <paragraph num="(12)"> <text>“Nuclear medicine technologist” means an individual licensed by the Board to practice nuclear medicine technology.</text> </paragraph> <paragraph num="(13)"> <text>“On-site supervision” means the responsibility of a licensed physician to provide necessary direction for a licensee when the physician is:</text> <paragraph num="(a)"> <text>Physically present in the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Able to respond in person if the licensee needs assistance with a procedure.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Physician” means an individual who is licensed by the Board to practice medicine.</text> </paragraph> <paragraph num="(15)"> <text>“Post–primary computed tomography (CT) credential” means passing a specialty examination by the ARRT or the NMTCB to establish competency in performing computed tomography.</text> </paragraph> <paragraph num="(16)"> <text>“Practice nuclear medicine technology” means to:</text> <paragraph num="(a)"> <text>Prepare and administer radiopharmaceuticals to human beings; or</text> </paragraph> <paragraph num="(b)"> <text>Conduct in vivo detection and measurement of radioactivity for medical purposes to assist the physician in the diagnosis and treatment of disease or injury.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Practice radiation therapy” means to perform tumor localization radiography and apply therapeutic doses of radiation for the treatment of disease or injury.</text> </paragraph> <paragraph num="(18)"> <text>“Practice radiography” means to use ionizing radiation to:</text> <paragraph num="(a)"> <text>Demonstrate portions of the human body to assist the physician in the diagnosis of disease or injury; or</text> </paragraph> <paragraph num="(b)"> <text>Perform tumor localization radiography.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Practice radiology assistance” means to:</text> <paragraph num="(a)"> <text>Practice radiography; and</text> </paragraph> <paragraph num="(b)"> <text>Perform:</text> <paragraph num="(i)"> <text>Fluoroscopy and selected radiology procedures;</text> </paragraph> <paragraph num="(ii)"> <text>Patient assessment; and</text> </paragraph> <paragraph num="(iii)"> <text>Patient management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Radiation therapist” means an individual licensed by the Board to practice radiation therapy.</text> </paragraph> <paragraph num="(21)"> <text>“Radiographer” means an individual who is licensed by the Board to practice radiography.</text> </paragraph> <paragraph num="(22)"> <text>“Radiologist” means a licensed physician who:</text> <paragraph num="(a)"> <text>Specializes in radiology; and</text> </paragraph> <paragraph num="(b)"> <text>Has current certification in radiology by one of the following organizations:</text> <paragraph num="(i)"> <text>American Board of Radiology;</text> </paragraph> <paragraph num="(ii)"> <text>American Osteopathic Board of Radiology;</text> </paragraph> <paragraph num="(iii)"> <text>British Royal College of Radiology; or</text> </paragraph> <paragraph num="(iv)"> <text>Royal College of Physicians and Surgeons of Canada.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Special procedure request” means a written request to the Board to allow a licensed radiologist assistant to perform one or more procedures listed in Regulation .11E of this chapter.</text> </paragraph> <paragraph num="(24)"> <text>“Supervision” means the responsibility of the licensed physician to exercise on-site direction or immediately available direction for licensees.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Committee."> <paragraph num="A."> <text>The Board shall establish a Committee composed of the following individuals:</text> <paragraph num="(1)"> <text>One physician whose approved specialty is radiology;</text> </paragraph> <paragraph num="(2)"> <text>One physician whose approved specialty is nuclear medicine;</text> </paragraph> <paragraph num="(3)"> <text>One physician whose approved specialty is radiation oncology;</text> </paragraph> <paragraph num="(4)"> <text>One physician who specializes in radiology and who supervises a radiologist assistant;</text> </paragraph> <paragraph num="(5)"> <text>One radiographer;</text> </paragraph> <paragraph num="(6)"> <text>One radiation therapist;</text> </paragraph> <paragraph num="(7)"> <text>One nuclear medicine technologist;</text> </paragraph> <paragraph num="(8)"> <text>One radiologist assistant;</text> </paragraph> <paragraph num="(9)"> <text>One consumer member; and</text> </paragraph> <paragraph num="(10)"> <text>One Board member.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Selection.</text> <paragraph num="(1)"> <text>The physician whose specialty is radiology, the physician whose specialty is radiation oncology, and the physician who specializes in radiology and supervises a radiologist assistant may be selected by the Board from a list of nominees submitted by the American College of Radiology—Maryland Chapter. Nominees are not required to be members of the American College of Radiology.</text> </paragraph> <paragraph num="(2)"> <text>The physician whose specialty is nuclear medicine may be selected by the Board from a list of nominees submitted by the Mideastern Chapter—Society of Nuclear Medicine. Nominees are not required to be members of the Mideastern Chapter—Society of Nuclear Medicine.</text> </paragraph> <paragraph num="(3)"> <text>The radiographer and the radiation therapist may be selected by the Board from a list of nominees submitted by the Maryland Society of Radiologic Technologists. Nominees are not required to be members of the Maryland Society of Radiologic Technologists.</text> </paragraph> <paragraph num="(4)"> <text>The nuclear medicine technologist may be selected by the Board from a list of nominees submitted by the Mideastern Chapter—Society of Nuclear Medicine —Technologist Section. Nominees are not required to be members of the Mideastern Chapter—Society of Nuclear Medicine—Technologist Section.</text> </paragraph> <paragraph num="(5)"> <text>The consumer member shall:</text> <paragraph num="(a)"> <text>Meet the requirements in Health Occupations Article, §14-5B-05(d), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Be selected by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second term but the individual may not serve more than two full consecutive terms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs as to a member, the Board shall appoint a new member to serve, as provided in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall only serve for the remainder of the term, unless reappointed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Committee shall elect a chair from among its members once every 2 years.</text> </paragraph> <paragraph num="F."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Review selected applications for licensure of radiographers, nuclear medicine technologists, radiation therapists, and radiologist assistants, and make recommendations to the Board for approval;</text> </paragraph> <paragraph num="(2)"> <text>Make recommendations to the Board regarding regulations governing radiographers, nuclear medicine technologists, radiation therapists, and radiologist assistants;</text> </paragraph> <paragraph num="(3)"> <text>Make recommendations to the Board on the requirements for licensure of radiographers, radiation therapists, nuclear medicine technologists, and radiologist assistants;</text> </paragraph> <paragraph num="(4)"> <text>Make recommendations to the Board on a code of ethics for the practice of radiography, radiation therapy, nuclear medicine technology, and radiology assistance;</text> </paragraph> <paragraph num="(5)"> <text>Advise the Board on matters related to standards of care for the practice of radiography, nuclear medicine technology, radiation therapy, and radiology assistance;</text> </paragraph> <paragraph num="(6)"> <text>Advise the Board on matters related to the practice of radiography, nuclear medicine technology, radiation therapy, and radiology assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Keep a record of the Committee's proceedings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Licensure — Radiographer."> <paragraph num="A."> <text>An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual shall be licensed by the Board if the individual:</text> <paragraph num="(1)"> <text>Completes an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays an application fee as specified in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrates oral and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English;</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has successfully completed and graduated from a radiographer educational program that is recognized by the ARRT or its successor;</text> </paragraph> <paragraph num="(7)"> <text>Has passed the examination in radiography constructed by the ARRT or its successor; and</text> </paragraph> <paragraph num="(8)"> <text>Has been certified and maintains current registration or active certification from the ARRT or its successor, at the time of application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications for Licensure — Nuclear Medicine Technologist."> <paragraph num="A."> <text>An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual shall be licensed by the Board if the individual:</text> <paragraph num="(1)"> <text>Completes an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays an application fee as specified in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrates oral and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English;</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has successfully completed and graduated from a nuclear medicine educational program that is recognized by the ARRT or its successor, or the NMTCB or its successor;</text> </paragraph> <paragraph num="(7)"> <text>Has passed the examination in nuclear medicine technology constructed by the ARRT or its successor, or the NMTCB or its successor; and</text> </paragraph> <paragraph num="(8)"> <text>Has been certified and maintains current registration or active certification from the ARRT or its successor, or the NMTCB or its successor at the time of application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Qualifications for Licensure — Radiation Therapists."> <paragraph num="A."> <text>An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual shall be licensed by the Board if the individual:</text> <paragraph num="(1)"> <text>Completes an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays an application fee as specified in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrates oral and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English;</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has successfully completed and graduated from a radiation therapy educational program that is recognized by the ARRT or its successor;</text> </paragraph> <paragraph num="(7)"> <text>Has passed the examination in radiation therapy constructed by the AART or its successor; and</text> </paragraph> <paragraph num="(8)"> <text>Has been certified and maintains current registration or active certification from the AART or its successor at the time of application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-2" heading="Qualifications for Licensure — Radiologist Assistants."> <paragraph num="A."> <text>An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual shall be licensed by the Board if the individual:</text> <paragraph num="(1)"> <text>Completes an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays an application fee as specified in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrates oral and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; or</text> </paragraph> <paragraph num="(c)"> <text>Receiving a grade of:</text> <paragraph num="(i)"> <text>At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Has been educated as follows:</text> <paragraph num="(a)"> <text>Completed a radiologist assistant educational program that is recognized by the ARRT or its successor; and</text> </paragraph> <paragraph num="(b)"> <text>Successfully completed coursework that leads to a baccalaureate degree or post-baccalaureate certificate;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Has passed the examination administered by the ARRT or its successor; and</text> </paragraph> <paragraph num="(8)"> <text>Has been certified and maintains current registration or active certification from the ARRT or its successor at the time of application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements specified in §B of this regulation, an applicant for a license as a radiologist assistant shall have:</text> <paragraph num="(1)"> <text>A current Maryland license as a radiographer;</text> </paragraph> <paragraph num="(2)"> <text>Completed a radiologist or radiation oncologist-directed clinical preceptorship as a part of the educational program required by §B(6) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Current certification in advanced cardiac life support; and</text> </paragraph> <paragraph num="(4)"> <text>Current certification as a radiologist assistant by the ARRT or its successor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Temporary Licensure — Repealed." /> <regulation prefix="Regulation" num=".07" heading="Scope of Practice — General."> <paragraph num="A."> <text>Supervision.</text> <paragraph num="(1)"> <text>A radiation therapist, radiographer, or a nuclear medicine technologist may practice only under the supervision of a licensed physician.</text> </paragraph> <paragraph num="(2)"> <text>A licensed radiologist assistant may practice only under the supervision of a licensed radiologist or radiation oncologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Administration of Medications or Contrast Media.</text> <paragraph num="(1)"> <text>A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant may initiate an intravenous line and administer contrast media with the following supervision:</text> <paragraph num="(a)"> <text>A radiologist assistant may administer contrast media under the immediately available direction of a radiologist or radiation oncologist; and</text> </paragraph> <paragraph num="(b)"> <text>A radiation therapist, radiographer, or nuclear medicine technologist may administer contrast media after consultation with a physician who is physically available on the premises.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant may not administer narcotic or sedating medication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Identification. A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant, when practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance shall wear a badge which identifies the individual wearing the badge to be a licensed radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Scope of Practice — Radiation Therapy."> <text>The practice of radiation therapy includes the following:</text> <paragraph num="A."> <text>Scope of practice for simulation procedures and for operation of external beam treatment devices, CT simulator, and fluoroscopic simulator for patient therapy which includes:</text> <paragraph num="(1)"> <text>Preparation of machine for patient procedure;</text> </paragraph> <paragraph num="(2)"> <text>Positioning patient for treatment or localization, or both;</text> </paragraph> <paragraph num="(3)"> <text>Adjustment of machine components and systems;</text> </paragraph> <paragraph num="(4)"> <text>Application of machine adjustments while patient is on the table;</text> </paragraph> <paragraph num="(5)"> <text>Attachment or removal of any machine device or machine accessory for patient service, or both;</text> </paragraph> <paragraph num="(6)"> <text>Manipulation of machine controls for patient exposure for localization or treatment, or both;</text> </paragraph> <paragraph num="(7)"> <text>Production of radiation for tumor or field localization on, or treatment of, a patient, or both;</text> </paragraph> <paragraph num="(8)"> <text>Documentation of technical set up used on a patient;</text> </paragraph> <paragraph num="(9)"> <text>Monitoring of patient and equipment during the simulation or treatment procedures for application of corrective actions;</text> </paragraph> <paragraph num="(10)"> <text>Oversight and application of image development standards and appropriate labeling of images regarding patient identification, date, and documentation of technical parameters;</text> </paragraph> <paragraph num="(11)"> <text>Performance of patient or image measurements, or both;</text> </paragraph> <paragraph num="(12)"> <text>Application of technical procedures in accordance with accepted radiation safety standards and regulations;</text> </paragraph> <paragraph num="(13)"> <text>Performance of dosimetric and geometric calculations related to patient treatment; and</text> </paragraph> <paragraph num="(14)"> <text>Manipulation, data entry, or other use of computer-accelerator interfaced hardware or software for patient treatment;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Scope of practice for preparation of patient treatment devices which includes:</text> <paragraph num="(1)"> <text>Oversight of in-facility manufacture of devices or device accessories for use in patient treatment; and</text> </paragraph> <paragraph num="(2)"> <text>Approval of devices for use in patient simulation and treatment;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Scope of practice for brachytherapy and radiopharmaceutical procedures which includes:</text> <paragraph num="(1)"> <text>Removal, return, or handling of radiation sources or medical applicators, or both, containing radioactive material;</text> </paragraph> <paragraph num="(2)"> <text>Transportation of radioactive materials;</text> </paragraph> <paragraph num="(3)"> <text>Documentation for the accountability and use of the radiation sources;</text> </paragraph> <paragraph num="(4)"> <text>Insertion and removal of sources from medical applicators;</text> </paragraph> <paragraph num="(5)"> <text>Preparation of sealed radiopharmaceuticals for therapeutic administration to patients under physician supervision;</text> </paragraph> <paragraph num="(6)"> <text>Assisting the licensed physician in the preparation and administration of sealed therapeutic radiopharmaceuticals for brachytherapy;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of the therapeutic application of radiopharmaceuticals;</text> </paragraph> <paragraph num="(8)"> <text>Oversight of radiation safety practices related to the handling and administration of radiopharmaceuticals for therapy of patients;</text> </paragraph> <paragraph num="(9)"> <text>Management of transportation and handling of therapeutic radiopharmaceuticals, immediate management and appropriate notifications for any spills or other accidents involving radiopharmaceuticals;</text> </paragraph> <paragraph num="(10)"> <text>Calibration of therapeutic radiopharmaceuticals for dose accuracy; and</text> </paragraph> <paragraph num="(11)"> <text>Preparation of unsealed radiopharmaceuticals for therapeutic administration to patients under direct supervision by a licensed physician if the radiation therapist has received on-site training from an authorized user; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Performance of any other duties that the Board determines may be performed by a radiation therapist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Scope of Practice — Radiography."> <paragraph num="A."> <text>The scope of practice of radiography includes the following:</text> <paragraph num="(1)"> <text>Analysis and correlation of procedure requests and clinical information provided by a physician or patient, or both, for preprocedure determination of the appropriate exam, its extent, and its scope;</text> </paragraph> <paragraph num="(2)"> <text>Evaluation of the physical and emotional status of the patient with respect to the ability to undergo the procedure requested;</text> </paragraph> <paragraph num="(3)"> <text>Selection, preparation, and operation of radiography equipment and accessories to perform procedures;</text> </paragraph> <paragraph num="(4)"> <text>Positioning patient to best demonstrate anatomy of interest, while respecting patient's physical limitations and comfort;</text> </paragraph> <paragraph num="(5)"> <text>Determination of radiographic exposure factors, setting of factors on control panel, and application of x-ray exposures;</text> </paragraph> <paragraph num="(6)"> <text>Application of radiation protection principles to minimize radiation exposure to patient, self, and others;</text> </paragraph> <paragraph num="(7)"> <text>Evaluation of images for technical quality;</text> </paragraph> <paragraph num="(8)"> <text>Performance of noninterpretive fluoroscopic procedures according to institutional policy;</text> </paragraph> <paragraph num="(9)"> <text>Oversight of image processing standards and the appropriate labeling of images;</text> </paragraph> <paragraph num="(10)"> <text>Administering contrast media after consultation with, and under the supervision of, a physician who is immediately and physically available; and</text> </paragraph> <paragraph num="(11)"> <text>Performing any other duties that the Board determines may be performed by a radiographer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The scope of practice of radiography includes the administration of intravenous medications and other patient care procedures as directed by the physician if the:</text> <paragraph num="(1)"> <text>Radiographer is:</text> <paragraph num="(a)"> <text>Registered by the ARRT in advanced qualifications in cardiac-interventional radiography, vascular-interventional radiography, or cardiovascular-interventional radiography;</text> </paragraph> <paragraph num="(b)"> <text>Working in a cardiac catheterization laboratory or interventional radiographic laboratory while cardiac catheterization or interventional procedures are ongoing; and</text> </paragraph> <paragraph num="(c)"> <text>Administering the medication or performing a patient care procedure at the direction of a physician while the physician is present in the room directing the administration and dosage of medication or performance of the patient care procedure;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supervising physician in the cardiac catheterization or interventional laboratory is responsible for the acts of the radiographer when delegating the administration of intravenous medications or performance of a patient care procedure; and</text> </paragraph> <paragraph num="(3)"> <text>Facility where the procedure is performed:</text> <paragraph num="(a)"> <text>Has protocols available for review by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Documents the training provided to the radiographer; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluates the radiographer on a regular basis for competency, documents the results of these tests, and makes the results available for inspection by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The scope of practice of radiography includes the insertion and removal of peripherally inserted central catheters with or without fluoroscopic guidance if the:</text> <paragraph num="(1)"> <text>Radiographer is:</text> <paragraph num="(a)"> <text>Registered by the ARRT in advanced qualifications in cardiac-interventional radiography, vascular-interventional radiography, or cardiovascular-interventional radiography;</text> </paragraph> <paragraph num="(b)"> <text>Working in a cardiac catheterization laboratory or interventional radiographic laboratory while cardiac catheterization or interventional procedures are ongoing; and</text> </paragraph> <paragraph num="(c)"> <text>Under the onsite supervision of the supervising physician;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supervising physician in the cardiac catheterization or interventional laboratory is responsible for the acts of the radiographer with respect to insertion or removal of peripherally inserted central catheters; and</text> </paragraph> <paragraph num="(3)"> <text>Facility where the procedure is performed:</text> <paragraph num="(a)"> <text>Has protocols available for review by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Documents the training provided to the radiographer; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluates the radiographer on a regular basis for competency, documents the results of these tests, and makes the results available for inspection by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Scope of Practice — Nuclear Medicine Technology."> <paragraph num="A."> <text>The scope of practice of nuclear medicine technology includes the following:</text> <paragraph num="(1)"> <text>Scope of practice for diagnostic in-vivo procedures and in-vitro procedures which includes:</text> <paragraph num="(a)"> <text>Analysis and correlation of procedure request and clinical information provided by the referring physician or patient, or both, for determination of appropriate exam, extent, and scope;</text> </paragraph> <paragraph num="(b)"> <text>Evaluation of the physical and emotional status of the patient with respect to the ability to undergo the procedure requested;</text> </paragraph> <paragraph num="(c)"> <text>Immediate predose review of patient's identification, prescribed dose quantity and route of administration, and identification of the test agent designed to prevent dose misadministration;</text> </paragraph> <paragraph num="(d)"> <text>Preparation of the appropriate radiopharmaceutical with measurement of dose activity;</text> </paragraph> <paragraph num="(e)"> <text>Administration of appropriate diagnostic dose levels of radiopharmaceuticals;</text> </paragraph> <paragraph num="(f)"> <text>Administration of nonradioactive pharmaceuticals utilized in conjunction with a nuclear medicine imaging or in-vivo procedure, for example, cholecystokinin, furosemide, vitamin B12, in accordance with hospital or facility procedures, excluding narcotic and sedating medication;</text> </paragraph> <paragraph num="(g)"> <text>Selection of appropriate imaging or test parameters, or both;</text> </paragraph> <paragraph num="(h)"> <text>Obtaining images according to established protocols and any special views to optimize information as appropriate;</text> </paragraph> <paragraph num="(i)"> <text>Placement of patient in proper position using supportive materials and immobilizer as necessary;</text> </paragraph> <paragraph num="(j)"> <text>Assuring appropriate image labeling as to patient identification, position, and appropriate anatomic land marks for each view;</text> </paragraph> <paragraph num="(k)"> <text>Evaluation of images or data, or both, for technical quality;</text> </paragraph> <paragraph num="(l)"> <text>Recognition of unusual variances in the images or data, or both, caused by instrumentation malfunction and initiating appropriate action;</text> </paragraph> <paragraph num="(m)"> <text>Monitoring of patient and equipment during procedure for determination and application of any corrective actions necessary;</text> </paragraph> <paragraph num="(n)"> <text>Monitoring of data collection and processing and performance of technical analysis of test results;</text> </paragraph> <paragraph num="(o)"> <text>Preparation and performance of laboratory in-vivo nuclear medicine procedures, inclusive of the selection and operation of laboratory counting equipment, performance of calculations and data processing necessary for completion of lab procedures and the submission of results to the physician or licensee;</text> </paragraph> <paragraph num="(p)"> <text>Oversight and application of image development; and</text> </paragraph> <paragraph num="(q)"> <text>Performance of in-vitro testing of serum, plasma, or other body fluids using radio immunoassay, or similar ligand assay methods;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Scope of practice for handling radiopharmaceuticals which includes:</text> <paragraph num="(a)"> <text>Preparation, by means of tagging, compounding, etc., in accordance with manufacturer's specifications;</text> </paragraph> <paragraph num="(b)"> <text>Measurement and calculation of activity of radionuclides with a dose calibrator;</text> </paragraph> <paragraph num="(c)"> <text>Application of radioactive decay calculations to determine required volume or unit form necessary to deliver the prescribed radioactive dose; and</text> </paragraph> <paragraph num="(d)"> <text>Recording of radiopharmaceutical information on a patient's permanent record;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Scope of practice for radionuclide therapy which includes:</text> <paragraph num="(a)"> <text>Assisting licensed physician in the preparation and applications of therapeutic radionuclides;</text> </paragraph> <paragraph num="(b)"> <text>Oversight of radiation safety practices related to the handling and administration of radiopharmaceuticals for therapy of patients;</text> </paragraph> <paragraph num="(c)"> <text>Management of transportation and handling of therapeutic radiopharmaceuticals;</text> </paragraph> <paragraph num="(d)"> <text>Calibration of therapeutic radiopharmaceuticals for dose accuracy; and</text> </paragraph> <paragraph num="(e)"> <text>Radiation monitoring, decontamination, disposal, and patient follow-up as appropriate and required;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Scope of practice for radiation safety which includes:</text> <paragraph num="(a)"> <text>Maintenance of records of radioactive material receipt, use, storage, and disposal in accordance with regulatory requirements;</text> </paragraph> <paragraph num="(b)"> <text>Oversight and enforcement of radiation safety policies, practices, and regulations regarding the possession and use of radioactive materials; and</text> </paragraph> <paragraph num="(c)"> <text>Performance of radiation safety procedures such as radiation survey and wipe testing of incoming radioactive shipments and facility fixtures;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Operation of a hybrid nuclear medicine/CT device for a nondiagnostic attenuation correction CT without intravenous contrast; and</text> </paragraph> <paragraph num="(6)"> <text>Performing any other duties that the Board determines may be performed by a nuclear medicine technologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The scope of practice of a nuclear medicine technologist includes operation of a standalone CT or hybrid nuclear medicine/CT device for a diagnostic CT with or without intravenous contrast if the nuclear medicine technologist:</text> <paragraph num="(1)"> <text>Has successfully passed the ARRT or NMTCB specialty exam for CT; and</text> </paragraph> <paragraph num="(2)"> <text>Administers contrast media after consultation with, and under the supervision of, a physician who is immediately and physically available.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In order to meet the eligibility requirements to sit for the ARRT or the NMTCB post-primary CT examination, a licensed nuclear medicine technologist may perform all procedures involving diagnostic CT with or without intravenous contrast only under the direct supervision of a:</text> <paragraph num="(1)"> <text>Licensed nuclear medicine technologist with the post-primary CT credential;</text> </paragraph> <paragraph num="(2)"> <text>Licensed radiographer with the post-primary CT credential; or</text> </paragraph> <paragraph num="(3)"> <text>Licensed radiologist or radiation oncologist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Scope of Practice — Radiologist Assistant."> <paragraph num="A."> <text>The scope of practice of a radiologist assistant includes the following activities to obtain the clinical history and physical examination of the patient:</text> <paragraph num="(1)"> <text>Review the patient's medical record to verify the appropriateness of a specific exam or procedure;</text> </paragraph> <paragraph num="(2)"> <text>Interview the patient to obtain, verify, or update medical history;</text> </paragraph> <paragraph num="(3)"> <text>Explain procedure to the patient or significant others, including a description of risks, benefits, alternatives, and follow-up;</text> </paragraph> <paragraph num="(4)"> <text>Obtain informed consent;</text> </paragraph> <paragraph num="(5)"> <text>Determine if the patient has followed instructions in preparation for the exam such as diet and premedications;</text> </paragraph> <paragraph num="(6)"> <text>Assess risk factors that may be contraindications to the procedure such as health history, medications, pregnancy, psychological indicators, and alternative medicines;</text> </paragraph> <paragraph num="(7)"> <text>Obtain and evaluate vital signs;</text> </paragraph> <paragraph num="(8)"> <text>Perform physical examination and analysis of data such as signs and symptoms, laboratory values, and significant abnormalities, as required by the imaging procedure to be conducted; and</text> </paragraph> <paragraph num="(9)"> <text>Report findings related to Regulation .10A(1)—(5) of this chapter to the supervising radiologist or radiation oncologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The scope of practice of a radiologist assistant includes the following general procedures:</text> <paragraph num="(1)"> <text>Apply ECG leads and recognize life threatening ECG abnormalities;</text> </paragraph> <paragraph num="(2)"> <text>Perform urinary catheterization;</text> </paragraph> <paragraph num="(3)"> <text>Perform venipuncture;</text> </paragraph> <paragraph num="(4)"> <text>Monitor IV for flow rate and complications;</text> </paragraph> <paragraph num="(5)"> <text>Position patient to perform required procedure, using immobilization devices and modifying technique as necessary;</text> </paragraph> <paragraph num="(6)"> <text>Assess patient's vital signs and levels of anxiety and pain and inform the radiologist or radiation oncologist when appropriate;</text> </paragraph> <paragraph num="(7)"> <text>Recognize and respond to medical emergencies, such as drug reactions, cardiac arrest, and hypoglycemia, and activate emergency response systems, including notification of the radiologist;</text> </paragraph> <paragraph num="(8)"> <text>Administer oxygen as prescribed;</text> </paragraph> <paragraph num="(9)"> <text>Operate a fixed/mobile fluoroscopic unit;</text> </paragraph> <paragraph num="(10)"> <text>Assure documentation of fluoroscopy time;</text> </paragraph> <paragraph num="(11)"> <text>Explain effects and potential side effects to the patient of the pharmaceutical required for the examination;</text> </paragraph> <paragraph num="(12)"> <text>Administer contrast agents as prescribed by the radiologist or radiation oncologist;</text> </paragraph> <paragraph num="(13)"> <text>Administer general medications, excluding radiopharmaceuticals and narcotic or sedating medications, as prescribed by the radiologist; and</text> </paragraph> <paragraph num="(14)"> <text>Monitor patient for side effects or complications of the pharmaceuticals.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The scope of practice of the radiologist assistant includes performing the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment, under the immediate available direction of a radiologist or radiation oncologist:</text> <paragraph num="(1)"> <text>Upper GI;</text> </paragraph> <paragraph num="(2)"> <text>Esophagus;</text> </paragraph> <paragraph num="(3)"> <text>Small bowel studies;</text> </paragraph> <paragraph num="(4)"> <text>Barium enema;</text> </paragraph> <paragraph num="(5)"> <text>Evaluation of percutaneous gastric and enteric tubes;</text> </paragraph> <paragraph num="(6)"> <text>Swallowing study;</text> </paragraph> <paragraph num="(7)"> <text>Cystogram and voiding cystourethrogram; and</text> </paragraph> <paragraph num="(8)"> <text>Nasoenteric and oroenteric feeding tube placement.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The scope of practice of the radiologist assistant includes performing the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment, under the on-site supervision of a radiologist or radiation oncologist:</text> <paragraph num="(1)"> <text>Joint injection and aspiration;</text> </paragraph> <paragraph num="(2)"> <text>Arthrogram, including conventional, CT, and MR;</text> </paragraph> <paragraph num="(3)"> <text>PICC placement;</text> </paragraph> <paragraph num="(4)"> <text>Paracentesis with appropriate image guidance;</text> </paragraph> <paragraph num="(5)"> <text>Thoracentesis with appropriate image guidance;</text> </paragraph> <paragraph num="(6)"> <text>Lumbar puncture under fluoroscopic guidance;</text> </paragraph> <paragraph num="(7)"> <text>Fistulogram; and</text> </paragraph> <paragraph num="(8)"> <text>Port injection.</text> </paragraph> </paragraph> <paragraph num="E."> <text>On a case-by-case basis as specified in Regulation .12 of this chapter, the Board or its designee may approve a radiologist assistant to perform one or more of the following procedures under the level of supervision by a radiologist or radiation oncologist as specified in the request letter submitted by the radiologist or radiation oncologist and radiologist assistant:</text> <paragraph num="(1)"> <text>Lower extremity venography;</text> </paragraph> <paragraph num="(2)"> <text>Lumbar, thoracic, or cervical myelography;</text> </paragraph> <paragraph num="(3)"> <text>Non-tunneled venous central line placement;</text> </paragraph> <paragraph num="(4)"> <text>Venous catheter placement for dialysis;</text> </paragraph> <paragraph num="(5)"> <text>Breast needle localization;</text> </paragraph> <paragraph num="(6)"> <text>Ductogram (galactogram);</text> </paragraph> <paragraph num="(7)"> <text>T-tube cholangiogram;</text> </paragraph> <paragraph num="(8)"> <text>Retrograde urethrogram;</text> </paragraph> <paragraph num="(9)"> <text>Sinogram;</text> </paragraph> <paragraph num="(10)"> <text>Loopogram;</text> </paragraph> <paragraph num="(11)"> <text>Hysterosalpingogram; and</text> </paragraph> <paragraph num="(12)"> <text>Other specific procedures approved by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The scope of practice of a radiologist assistant includes the following post-imaging activities:</text> <paragraph num="(1)"> <text>Review of imaging procedures, making initial observations, and communicating observations only to the radiologist or radiation oncologist;</text> </paragraph> <paragraph num="(2)"> <text>Communication of radiologist's report to referring physician;</text> </paragraph> <paragraph num="(3)"> <text>Provision of radiologist-prescribed post-care instructions to patients;</text> </paragraph> <paragraph num="(4)"> <text>Performance of follow-up patient evaluation, and communication of findings to the radiologist or radiation oncologist;</text> </paragraph> <paragraph num="(5)"> <text>Documenting procedure in appropriate record, and documenting exceptions from established protocol or procedure;</text> </paragraph> <paragraph num="(6)"> <text>Writing patient discharge summary for review and co-signature by the radiologist or the radiation oncologist;</text> </paragraph> <paragraph num="(7)"> <text>Participating in quality improvement activities within radiology practice; and</text> </paragraph> <paragraph num="(8)"> <text>Assisting with data collection and review for clinical trials or other research.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Request for Radiologist Assistant to Perform Advanced Procedures."> <paragraph num="A."> <text>Eligibility. The Board may grant a radiologist assistant permission to perform one or more of the procedures specified in Regulation .11E of this chapter based on the following criteria:</text> <paragraph num="(1)"> <text>Evidence of satisfactory completion of an adequate number of cases for the procedure being requested; and</text> </paragraph> <paragraph num="(2)"> <text>Level of supervision of the radiologist assistant, as specified by the radiologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Request. The radiologist or radiation oncologist and radiologist assistant shall jointly request approval to perform a special procedure by submitting a letter that includes the following information:</text> <paragraph num="(1)"> <text>Special procedures requested; and</text> </paragraph> <paragraph num="(2)"> <text>Documentation of satisfactory completion of an adequate number of cases of the procedure.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Training and Experience. Documentation of successful completion of cases of a procedure may include:</text> <paragraph num="(1)"> <text>Cases submitted to ARRT for registration as a registered radiologist assistant; and</text> </paragraph> <paragraph num="(2)"> <text>Other cases performed under the supervision of a radiologist or radiation oncologist who is present and observing the procedure.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Board Approval.</text> <paragraph num="(1)"> <text>Except as provided in §D(2) of this regulation, a licensed radiologist assistant may not perform any of the procedures specified in Regulation .11E of this chapter until the Board or its designee has approved the special procedure request submitted by the radiologist or radiation oncologist and radiologist assistant.</text> </paragraph> <paragraph num="(2)"> <text>A licensed radiologist assistant may perform a procedure for training purposes under the direct supervision of a radiologist who is:</text> <paragraph num="(a)"> <text>Physically present with the patient and the radiologist assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Observing the performance of the procedure by the radiologist assistant.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Renewal and Reinstatement."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has been licensed by the Board as a radiation therapist, radiographer, or nuclear medicine technologist shall renew the license every 2 years on the date specified by the Board by:</text> <paragraph num="(a)"> <text>Completing a renewal application on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying a renewal fee as specified in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Attesting to one of the following:</text> <paragraph num="(i)"> <text>Completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the expiration of the license for radiation therapist, radiographer, or nuclear medicine technologist, in accordance with the requirements specified in §A(5) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Current American Registry of Radiologic Technologists (ARRT) registration; or</text> </paragraph> <paragraph num="(iii)"> <text>Active certification by the Nuclear Medicine Technology Certification Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An individual who has been licensed by the Board as a radiologist assistant shall renew the license every 2 years on the date specified by the Board by:</text> <paragraph num="(a)"> <text>Completing a renewal application on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying a renewal fee as specified in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to one of the following:</text> <paragraph num="(i)"> <text>Completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the expiration of the license for radiologist assistant, in accordance with the requirements specified in §A(5) of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>Current American Registry of Radiologic Technologists (ARRT) registration as a radiologist assistant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Continuing education hours that are used to satisfy the continuing education requirement for renewal of a license as a radiographer may also be used to satisfy the continuing education requirement for a radiologist assistant.</text> </paragraph> <paragraph num="(5)"> <text>Approved continuing education is as follows:</text> <paragraph num="(a)"> <text>In-service programs at a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a health maintenance organization certified by the State; or</text> </paragraph> <paragraph num="(b)"> <text>Programs relevant to the practice of a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant approved by the:</text> <paragraph num="(i)"> <text>American College of Radiology or its chapters;</text> </paragraph> <paragraph num="(ii)"> <text>Maryland Society of Radiologic Technologists;</text> </paragraph> <paragraph num="(iii)"> <text>Mideastern Chapter—Society of Nuclear Medicine — Technologist Section;</text> </paragraph> <paragraph num="(iv)"> <text>Mideastern Chapter—Society of Nuclear Medicine or the District of Columbia Chapter of the American College of Radiology;</text> </paragraph> <paragraph num="(v)"> <text>American Medical Association;</text> </paragraph> <paragraph num="(vi)"> <text>MedChi, the Maryland State Medical Society; or</text> </paragraph> <paragraph num="(vii)"> <text>American Society of Radiologic Technologists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>The continuing education requirement applies to all renewal applications after the first renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement. The Board shall reinstate the license of a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant if the individual:</text> <paragraph num="(1)"> <text>Completes a reinstatement application on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays a reinstatement fee as defined in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Documents evidence of:</text> <paragraph num="(a)"> <text>For a radiographer, radiation therapist, or nuclear medicine technologist, at least one of the following requirements:</text> <paragraph num="(i)"> <text>Completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement of the license for radiation therapist, radiographer, or nuclear medicine technologist;</text> </paragraph> <paragraph num="(ii)"> <text>Current ARRT registration; or</text> </paragraph> <paragraph num="(iii)"> <text>Active certification by the NMTCB; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a radiologist assistant, at least one of the following requirements:</text> <paragraph num="(i)"> <text>Completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement of the license for radiologist assistant; or</text> </paragraph> <paragraph num="(ii)"> <text>Current ARRT registration as a radiologist assistant.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Prohibited Conduct."> <paragraph num="A."> <text>Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, the Board may deny an application, may reprimand any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, licensed radiologist assistant, place any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, licensed radiologist assistant, on probation, or suspend or revoke the license of any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, or licensed radiologist assistant for the commission of a prohibited act.</text> </paragraph> <paragraph num="B."> <text>The following are prohibited acts:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or licensed individual or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively using a license;</text> </paragraph> <paragraph num="(3)"> <text>Being guilty of unprofessional or immoral conduct in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance;</text> </paragraph> <paragraph num="(4)"> <text>Being professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandoning a patient;</text> </paragraph> <paragraph num="(6)"> <text>Habitually being intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Being addicted to or abusing any narcotic or controlled dangerous substance as defined in Criminal Law Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Providing professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol;</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promoting the sale of services, drugs, devices, appliances, or goods to a patient to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully making or filing a false report or record in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance;</text> </paragraph> <paragraph num="(11)"> <text>Willfully failing to file or record any report as required under law, willfully impeding or obstructing the filing or recording of the report, or inducing another to fail to file or record the report;</text> </paragraph> <paragraph num="(12)"> <text>Paying or agreeing to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepting or agreeing to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(13)"> <text>Knowingly making a misrepresentation while practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance with an unauthorized person or aiding an unauthorized person in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance;</text> </paragraph> <paragraph num="(15)"> <text>Offering, undertaking, or agreeing to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(16)"> <text>Being disciplined by a licensing or disciplinary authority, being convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under the Board's disciplinary statutes or this regulation;</text> </paragraph> <paragraph num="(17)"> <text>Failing to meet appropriate standards as determined by appropriate peer review for the delivery of quality radiation therapy care, radiography care, nuclear medicine technology care, or radiology assistance care performed in an outpatient surgical facility, office, hospital, or any other location in this State;</text> </paragraph> <paragraph num="(18)"> <text>Knowingly submitting false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(19)"> <text>Having been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under this regulation and the licensed individual:</text> <paragraph num="(a)"> <text>Surrendered the license issued by the state or country, or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(21)"> <text>Selling, prescribing, giving away, or administering drugs for illegal or illegitimate purposes;</text> </paragraph> <paragraph num="(22)"> <text>Breaching patient confidentiality;</text> </paragraph> <paragraph num="(23)"> <text>Practicing beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(24)"> <text>Practicing or attempting to practice any radiation therapy, radiography, nuclear medicine technology, or radiology assistance procedure, or using radiation therapy, radiography, nuclear medicine technology, or radiology assistance equipment, if the applicant or licensed individual has not received education, training, or experience in the use of that procedure or the use of the equipment;</text> </paragraph> <paragraph num="(25)"> <text>Refusing, withholding from, denying, or discriminating against an individual with regard to the provision of professional services for which the license holder is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(26)"> <text>Failing to cooperate with a lawful investigation of the Board;</text> </paragraph> <paragraph num="(27)"> <text>Failing to practice under the supervision of a physician or violating a supervisory order of a supervising physician; or</text> </paragraph> <paragraph num="(28)"> <text>Failing to comply with these regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unprofessional conduct in the practice of medicine, under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing the physician's duty to supervise a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant.</text> </paragraph> <paragraph num="D."> <text>Crimes of Moral Turpitude.</text> <paragraph num="(1)"> <text>On the filing of certified docket entries with the Board by the Attorney General, the Board shall order the suspension of a license if the licensee has been convicted of, or pled guilty or nolo contendere with respect to, a crime involving moral turpitude, regardless of whether any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime of moral turpitude, the Board shall order the revocation of the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Investigations, Hearings, and Appeals."> <paragraph num="A."> <text>Complaints alleging prohibited conduct shall be referred to the Board to be investigated according to the Board's procedures.</text> </paragraph> <paragraph num="B."> <text>A hearing on charges issued under Regulation .14A of this chapter or Health Occupations Article, §14-5B-14(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5B-14(c), Annotated Code of Maryland, or Regulation .14D of this chapter shall be held in accordance with COMAR 10.32.02.04.</text> </paragraph> <paragraph num="D."> <text>All other hearings shall be held in accordance with the Administrative Procedure Act.</text> </paragraph> <paragraph num="E."> <text>Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5B-14.1, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Penalties, Fines, and Sanctioning Guidelines."> <paragraph num="A."> <text>The Board may impose a civil fine of not more than $5,000 on an individual who is not licensed to practice radiation therapy, radiography, nuclear medical technology, or radiology assistance in Maryland if the individual:</text> <paragraph num="(1)"> <text>Represents to the public in any way that the individual is authorized to practice radiation therapy, radiography, nuclear medicine technology, or radiology assistance;</text> </paragraph> <paragraph num="(2)"> <text>Practices or attempts to practice radiation therapy, radiography, nuclear medicine technology, or radiology assistance; or</text> </paragraph> <paragraph num="(3)"> <text>Violates any provision of Health Occupations Article, Title 14, Subtitle 5B, Annotated Code of Maryland, or any regulation in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall deposit a penalty collected under §A of this regulation into the Board of Physicians fund.</text> </paragraph> <paragraph num="C."> <text>The Board may impose a civil fine of not more than $1,000 on an individual who fails to file a report under Regulation .17 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board may impose a civil fine of not more than $1,000 on a licensed physician or employer who employs or supervises an individual practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance without a license.</text> </paragraph> <paragraph num="E."> <text>The Board shall deposit a fine collected under §D or E of this regulation into the General Fund.</text> </paragraph> <paragraph num="F."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections F and G of this regulation and Regulation .19 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §G of this regulation, for violations of the sections of the Maryland Radiation Therapy, Radiography, Nuclear Medicine Technology, and Radiology Assistance Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(d)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. If a minimum fine is listed, at least the minimum fine shall be imposed in addition to the sanction listed.</text> </paragraph> <paragraph num="(e)"> <text>The addition of a fine does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .19 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .19 of this chapter, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .19 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Board may impose a fine of $100 for a violation of Health Occupations Article, §14-5B-12.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="I."> <text>Offenses Related to Continuing Medical Education Credits.</text> <paragraph num="(1)"> <text>First Offense of Failure to Document Credits.</text> <paragraph num="(a)"> <text>Except as provided in §I(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5B-12, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5B-14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Section I(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5B-14(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5B-14(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5B-14(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5A-14, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees Previously Disciplined Under §I(1) or (2) of this Regulation.</text> <paragraph num="(a)"> <text>If a licensee has been previously fined or otherwise disciplined under §I(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5B-14(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5B-14(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5B-14(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5B-14, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(c)"> <text>The Board may not apply the sanction described in §I(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall pay all monies collected pursuant to §I of this regulation into the Board of Physicians Fund.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Required Reports."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an employer of a licensed radiation therapist, licensed radiographer, a licensed nuclear medical technologist, or licensed radiologist assistant shall report to the Board if the employer limits, reduces, or otherwise changes the responsibilities of or terminates a licensed therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant for any reason that might be grounds for disciplinary action under Health Occupations Article, Title 14, Subtitle 5B, Annotated Code of Maryland, or any regulation in this chapter.</text> </paragraph> <paragraph num="B."> <text>If the action taken by an employer under §A relates to alcohol or drug impairment, reporting shall be in compliance with Health Occupations Article, §14-5B-15(b),(c), and (d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant shall notify the licensee's employer of a decision to enter an accredited alcohol or drug treatment program.</text> </paragraph> <paragraph num="D."> <text>An accredited alcohol or drug treatment program that is treating a licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant who has given notice to his employer under §C of this regulation shall notify the employer if the licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant is found to be noncompliant with the treatment program's policies and procedures.</text> </paragraph> <paragraph num="E."> <text>An individual is not required to make a report under this regulation that would be in violation of any federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Fees."> <text>The following fees are applicable to radiation therapists, radiographers, nuclear medicine technologists, and radiologist assistants:</text> <paragraph num="A."> <text>Application for initial licensure fee — $150;</text> </paragraph> <paragraph num="B."> <text>Renewal Fees:</text> <paragraph num="(1)"> <text>Renewal of license fee — $135; and</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee — As determined by MHCC under COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement of license fee — $150;</text> </paragraph> <paragraph num="D."> <text>Written verification fee — $25; and</text> </paragraph> <paragraph num="E."> <text>Other Fees:</text> <paragraph num="(1)"> <text>Duplicate license — $25;</text> </paragraph> <paragraph num="(2)"> <text>Duplicate wall certificate — $25.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctioning Guidelines for Radiation Therapists, Radiographers, Nuclear Radiation Technologists, and Radiologist Assistants."> <paragraph num="A."> <text>Subject to provisions of Regulation .16F and G of this chapter, the Board may impose sanctions as outlined in §B of this regulation on a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant for violations of Health Occupations Article, §14-5B-14(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-606, 14-306, 14-5B-01, and 14-5B-03—14-5B-21, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective February 16, 1990 (17:6 Md. R. 735); emergency status extended at 17:17 Md. R. 2076 and 18:3 Md. R. 301; emergency status expired July 1, 1991</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective July 2, 1991 (18:14 Md. R. 1607); emergency status expired January 1, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted effective January 2, 1992 (18:21 Md. R. 2308)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 8, 1995 (22:9 Md. R. 645); March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed effective May 8, 1995 (22:9 Md. R. 645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 18, 1995 (22:25 Md. R. 1962); March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); adopted permanently effective November 3, 2008 (35:22 Md. R. 1957)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 8, 1995 (22:9 Md. R. 645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective December 2, 1996 (23:24 Md. R. 1682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 1, 2004 (31:4 Md. R. 316); June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective September 11, 1995 (22:18 Md. R. 1400); May 19, 1997 (24:10 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective February 13, 2003 (30:5 Md. R. 363); amended permanently effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, B amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 19, 2002 (29:16 Md. R. 1288); March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective March 1, 2004 (31:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted as an emergency provision effective February 13, 2003 (30:5 Md. R. 363); adopted permanently effective March 31, 2003 (30:6 Md. R. 420)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 12, 2014 (41:9 Md. R. 521); December 30, 2019 (46:26 Md. R. 1165); January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 27, 2010 (37:26 Md. R. 1788)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-2 adopted effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-2B, C amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C adopted effective March 2, 2015 (42:4 Md. R. 433)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, B amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective July 22, 2013 (40:14 Md. R. 1176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 adopted effective July 22, 2013 (40:14 Md. R. 1176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> </annotations> </chapter> <chapter num="11" heading="Licensing of Respiratory Care Practitioners"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of respiratory care.</text> </paragraph> <paragraph num="B."> <text>This chapter does not prohibit any respiratory care student who is currently enrolled in an approved respiratory care educational program from performing any of the procedures described in this chapter as part of that program's respiratory care clinical curriculum.</text> </paragraph> <paragraph num="C."> <text>This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>This chapter does not apply to an individual employed by the federal government as a respiratory care practitioner while the individual is practicing within the scope of that employment.</text> </paragraph> <paragraph num="E."> <text>This chapter does not apply to an individual practicing respiratory care who is licensed by and resides in another jurisdiction if:</text> <paragraph num="(1)"> <text>The individual is participating in the transportation of a patient from that individual’s jurisdiction of licensure into the State;</text> </paragraph> <paragraph num="(2)"> <text>The individual practices respiratory care only during the transportation of the patient;</text> </paragraph> <paragraph num="(3)"> <text>The individual does not practice respiratory care on another individual who is not the patient being transported into the State; and</text> </paragraph> <paragraph num="(4)"> <text>The individual does not practice respiratory care in the State for more than 14 days within a calendar year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“AARC” means the American Association for Respiratory Care.</text> </paragraph> <paragraph num="(2)"> <text>“Accredited respiratory care education program” means a program accredited by the Commission on Accreditation for Respiratory Care or its successor.</text> </paragraph> <paragraph num="(3)"> <text>“Applicant” means an individual who applies to the Board for licensure as a respiratory care practitioner.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical supervision” means the responsibility of a respiratory care practitioner to exercise on-site or immediately available direction for respiratory care departments, the provision of any respiratory care services, licensed respiratory care practitioners, or students practicing respiratory care.</text> </paragraph> <paragraph num="(6)"> <text>“Collaboration” means a respiratory care practitioner practicing in association with and under the direction of a physician to plan and implement a regimen of care.</text> </paragraph> <paragraph num="(7)"> <text>“Committee" means the Respiratory Care Professional Standards Committee of the Board.</text> </paragraph> <paragraph num="(8)"> <text>“Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which:</text> <paragraph num="(a)"> <text>Is composed of 11 Board members; and</text> </paragraph> <paragraph num="(b)"> <text>Addresses:</text> <paragraph num="(i)"> <text>Complaints and disciplinary actions against licensed physicians and allied health professionals;</text> </paragraph> <paragraph num="(ii)"> <text>Initial licensure decisions; and</text> </paragraph> <paragraph num="(iii)"> <text>Postdisciplinary licensure reinstatements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Licensee” means a licensed respiratory care practitioner.</text> </paragraph> <paragraph num="(10)"> <text>“Mechanical ventilation” means utilizing positive or negative pressure to provide inspiratory support by invasive or noninvasive means.</text> </paragraph> <paragraph num="(11)"> <text>“National Certifying Board” means the National Board for Respiratory Care, Inc. or its successor.</text> </paragraph> <paragraph num="(12)"> <text>“Physician” means an individual licensed to practice medicine in Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Practice of respiratory care” means the diagnostic evaluation, care and treatment, management, and rehabilitation of patients who have deficiencies and abnormalities which affect the pulmonary system and associated aspects of the cardiopulmonary and other systems.</text> </paragraph> <paragraph num="(14)"> <text>“Respiratory care practitioner” means an individual licensed by the Board to practice respiratory care.</text> </paragraph> <paragraph num="(15)"> <text>“Supervision” means the responsibility of a physician to exercise on-site or immediately available direction for a licensed respiratory care practitioner performing delegated medical acts.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference."> <text>The American Association for Respiratory Care Clinical Practice Guidelines (1997) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Committee."> <paragraph num="A."> <text>The Board shall establish a Respiratory Care Professional Standards Committee composed of the following individuals:</text> <paragraph num="(1)"> <text>Three licensed respiratory care practitioners;</text> </paragraph> <paragraph num="(2)"> <text>One licensed physician whose specialty is thoracic surgery;</text> </paragraph> <paragraph num="(3)"> <text>One licensed physician whose specialty is pulmonary medicine;</text> </paragraph> <paragraph num="(4)"> <text>One licensed physician whose specialty is anesthesiology; and</text> </paragraph> <paragraph num="(5)"> <text>One consumer member who meets the requirements specified in Health Occupations Article, §14-5A-06(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Chair.</text> <paragraph num="(1)"> <text>The Committee shall elect a chair from among its members.</text> </paragraph> <paragraph num="(2)"> <text>The chair shall serve for a term of 2 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>A member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(3)"> <text>A member appointed after a term has begun serves only for the rest of the term and until a successor has been appointed.</text> </paragraph> <paragraph num="(4)"> <text>A member may not serve more than 2 consecutive terms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Vacancy. If a vacancy occurs on the Committee, the Board shall appoint a new member to serve, as provided in §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the members then serving on the Committee constitutes a quorum.</text> </paragraph> <paragraph num="(2)"> <text>Business may not be conducted at a Committee meeting unless there is a quorum.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Committee may develop and make recommendations to the Board in any matters related to regulating the practice of respiratory care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Code of Ethics."> <paragraph num="A."> <text>A respiratory care practitioner shall:</text> <paragraph num="(1)"> <text>Practice medically acceptable methods of treatment and may not endeavor to practice beyond the competence and the authority vested in the respiratory care practitioner by the physician;</text> </paragraph> <paragraph num="(2)"> <text>Continually strive to increase and improve the knowledge and skill to render to each patient the full measure of the respiratory care practitioner's ability;</text> </paragraph> <paragraph num="(3)"> <text>Be responsible for the competent and efficient performance of assigned duties;</text> </paragraph> <paragraph num="(4)"> <text>Expose incompetence and illegal or unethical conduct of members of the profession;</text> </paragraph> <paragraph num="(5)"> <text>Hold in strict confidence all privileged information concerning the patient;</text> </paragraph> <paragraph num="(6)"> <text>Refer all inquiries to the physician in charge of the patient's medical care;</text> </paragraph> <paragraph num="(7)"> <text>Accept no gratuities for preferential consideration of the patient;</text> </paragraph> <paragraph num="(8)"> <text>Guard against conflicts of interest;</text> </paragraph> <paragraph num="(9)"> <text>Uphold the dignity and honor of the profession and abide by its ethical principles;</text> </paragraph> <paragraph num="(10)"> <text>Be familiar with existing State and federal laws governing the practice of respiratory care and comply with those laws; and</text> </paragraph> <paragraph num="(11)"> <text>Cooperate with other health care professionals and participate in activities to promote community and national efforts to meet the health needs of the public.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A breach of the ethical principles stated in §A of this regulation may be considered immoral or unprofessional conduct in the practice of respiratory care.</text> </paragraph> <paragraph num="C."> <text>All services shall be provided with respect for the dignity of the patient, unrestricted by considerations of social or economic status, personal attributes, or the nature of health problems.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Qualifications for Licensure as a Respiratory Care Practitioner."> <paragraph num="A."> <text>The Board shall license an individual if the individual meets the requirements of §§B and C of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual shall be licensed by the Board if the individual:</text> <paragraph num="(1)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrates spoken and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Graduation from a recognized English-speaking high school or undergraduate or graduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Graduation from a recognized English-speaking professional school; or</text> </paragraph> <paragraph num="(c)"> <text>Receipt of a grade of:</text> <paragraph num="(i)"> <text>At least 79 on the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 26 on the “Speaking” section of the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Graduate from an accredited respiratory care educational program; and</text> </paragraph> <paragraph num="(5)"> <text>Have active certification by the National Certifying Board as at least one of the following:</text> <paragraph num="(a)"> <text>Certified respiratory therapist; or</text> </paragraph> <paragraph num="(b)"> <text>Registered respiratory therapist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An individual shall submit a completed application form, which includes the following information:</text> <paragraph num="(1)"> <text>A chronological history of practice-related activities as requested by the Board for:</text> <paragraph num="(a)"> <text>All periods of time, including each job held; and</text> </paragraph> <paragraph num="(b)"> <text>Any other activity engaged in, including all periods of unemployment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any physical or mental condition that currently impairs the individual’s ability to practice respiratory care;</text> </paragraph> <paragraph num="(3)"> <text>Any action by a state licensing or disciplinary board or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal for a health care occupational license;</text> </paragraph> <paragraph num="(4)"> <text>Any health professional license for which the individual has applied if the application was withdrawn for reasons that would be grounds for disciplinary action;</text> </paragraph> <paragraph num="(5)"> <text>Any action taken against the individual’s license by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to:</text> <paragraph num="(a)"> <text>Limitations of practice;</text> </paragraph> <paragraph num="(b)"> <text>Required education;</text> </paragraph> <paragraph num="(c)"> <text>Admonishment;</text> </paragraph> <paragraph num="(d)"> <text>Reprimand;</text> </paragraph> <paragraph num="(e)"> <text>Suspension; or</text> </paragraph> <paragraph num="(f)"> <text>Revocation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Any investigation or charges brought against the individual by a state licensing or disciplinary board or comparable body in the armed services;</text> </paragraph> <paragraph num="(7)"> <text>Copies of:</text> <paragraph num="(a)"> <text>State licensing or disciplinary board charges;</text> </paragraph> <paragraph num="(b)"> <text>Final orders; or</text> </paragraph> <paragraph num="(c)"> <text>Adverse or disciplinary actions;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Any investigation or charge brought against the individual by:</text> <paragraph num="(a)"> <text>A hospital;</text> </paragraph> <paragraph num="(b)"> <text>A related institution;</text> </paragraph> <paragraph num="(c)"> <text>An alternative health care system; or</text> </paragraph> <paragraph num="(d)"> <text>Any other employer;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Any limitation or loss in privileges by:</text> <paragraph num="(a)"> <text>A hospital;</text> </paragraph> <paragraph num="(b)"> <text>A related health care facility;</text> </paragraph> <paragraph num="(c)"> <text>An alternative health care system; or</text> </paragraph> <paragraph num="(d)"> <text>Any other employer;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Copies of the complaints, pleadings, and judgments in all malpractice claims;</text> </paragraph> <paragraph num="(11)"> <text>Copies of all arrests, court orders, orders of probation, certificates or letters of completion, or both, of any mandatory program or disciplinary actions, including final orders for driving while intoxicated or driving while under the influence of a chemical substance or medication;</text> </paragraph> <paragraph num="(12)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act; and</text> </paragraph> <paragraph num="(13)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant shall pay the required application fee.</text> </paragraph> <paragraph num="E."> <text>An applicant shall submit a passport-size photograph.</text> </paragraph> <paragraph num="F."> <text>On forms supplied by the Board, an applicant shall agree to release to the Board all relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to:</text> <paragraph num="(1)"> <text>The National Practitioner Data Bank;</text> </paragraph> <paragraph num="(2)"> <text>Hospitals; and</text> </paragraph> <paragraph num="(3)"> <text>Any other licensing body.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant for licensure shall inform the Board by certified mail, return receipt requested, within 30 days of the occurrence or notification of any of the circumstances listed in §B of this regulation.</text> </paragraph> <paragraph num="H."> <text>If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, the Board may request additional information regarding the applicant's competency from the chief of staff of a hospital where the applicant has practiced.</text> </paragraph> <paragraph num="I."> <text>If an applicant has not passed the National Certifying Board exam for credentialing as a Certified Respiratory Therapist or a Registered Respiratory Therapist within the 5 years immediately preceding the applicant’s application and has not practiced respiratory care for at least 3 of the past 5 years, the Board may require the applicant to take and pass one of those exams as part of the application process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Examination."> <paragraph num="A."> <text>A disciplinary panel may require an applicant for licensure or a licensee to submit to one or more physical, mental, or other examinations, by a physician or evaluation program for treatment of impaired respiratory care practitioners, or both, chosen by a disciplinary panel to determine the applicant's ability to practice respiratory care.</text> </paragraph> <paragraph num="B."> <text>The applicant or licensee shall pay the costs of the evaluations required in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Qualifications for Respiratory Care Practitioners Practicing Polysomnography."> <paragraph num="A."> <text>A respiratory care practitioner licensed by the Board to practice respiratory care on or before December 31, 2012, whose duties include practicing respiratory care in a sleep laboratory or practicing polysomnography, is not required to obtain an additional license to practice polysomnography.</text> </paragraph> <paragraph num="B."> <text>A respiratory care practitioner licensed after December 31, 2012, whose duties include practicing polysomnography shall obtain a separate license to practice polysomnography.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Scope of Practice, Identification, and Change in Name or Address."> <paragraph num="A."> <text>A respiratory care practitioner may practice only under the supervision of and in collaboration with a physician.</text> </paragraph> <paragraph num="B."> <text>The practice of respiratory care includes the following:</text> <paragraph num="(1)"> <text>Direct and indirect respiratory care services that are safe, aseptic, preventive, and restorative to the patient;</text> </paragraph> <paragraph num="(2)"> <text>The practice of the principles, techniques, and theories derived from cardiopulmonary medicine;</text> </paragraph> <paragraph num="(3)"> <text>Evaluation and treatment of individuals whose cardiopulmonary functions have been threatened or impaired by developmental defects, the aging process, physical injury, disease, or actual or anticipated dysfunction of the cardiopulmonary system;</text> </paragraph> <paragraph num="(4)"> <text>Observation and monitoring of physical signs and symptoms, general behavior, and general physical response to respiratory care procedures, and determination of whether initiation, modification, or discontinuation of the treatment regimen is warranted;</text> </paragraph> <paragraph num="(5)"> <text>The transcription and implementation of a written or oral order, or both, pertaining to the practice of respiratory care;</text> </paragraph> <paragraph num="(6)"> <text>Evaluation techniques including cardiopulmonary functional assessments, gas exchange, the need and effectiveness of therapeutic modalities and procedures, and assessment and evaluation of the need for extended care and home care procedures, therapy, and equipment;</text> </paragraph> <paragraph num="(7)"> <text>Professional application of techniques, equipment, and procedures involved in the administration of respiratory care such as:</text> <paragraph num="(a)"> <text>Therapeutic and diagnostic gases (excluding general anesthesia);</text> </paragraph> <paragraph num="(b)"> <text>Prescribed medications for inhalation or direct tracheal instillation;</text> </paragraph> <paragraph num="(c)"> <text>The administration of prescribed analgesic agents including substances listed in Schedule IV as defined in Criminal Law Article, §5-405, Annotated Code of Maryland, by subcutaneous injection or inhalation for the performance of respiratory care procedures;</text> </paragraph> <paragraph num="(d)"> <text>Nonsurgical intubation, maintenance, and extubation of artificial airways;</text> </paragraph> <paragraph num="(e)"> <text>Advanced cardiopulmonary measures;</text> </paragraph> <paragraph num="(f)"> <text>Chest needle decompression;</text> </paragraph> <paragraph num="(g)"> <text>Cardiopulmonary rehabilitation;</text> </paragraph> <paragraph num="(h)"> <text>Mechanical ventilation or physiological life support systems;</text> </paragraph> <paragraph num="(i)"> <text>Collection of body fluids and blood samples for evaluation and analysis, including collection by intraosseous access;</text> </paragraph> <paragraph num="(j)"> <text>Insertion of diagnostic arterial access lines, including large bore intravenous access; and</text> </paragraph> <paragraph num="(k)"> <text>Collection and analysis of exhaled respiratory gases;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The clinical supervision of licensed respiratory care practitioners, respiratory care departments, or the provision of any respiratory care services; and</text> </paragraph> <paragraph num="(9)"> <text>The respiratory care clinical instruction or oversight of respiratory care students, while performing respiratory care procedures as part of their clinical curriculum.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A respiratory care practitioner shall wear an identification tag or a badge which identifies that individual as a respiratory care practitioner.</text> </paragraph> <paragraph num="D."> <text>Change in Name or Address.</text> <paragraph num="(1)"> <text>Within 60 days after the change, a licensee shall notify the Board in writing of a change in name or address.</text> </paragraph> <paragraph num="(2)"> <text>Licensees who fail to notify the Board of name or address changes as required by §D(1) of this regulation are subject to an administrative penalty of $100.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Standard of Care."> <paragraph num="A."> <text>In evaluating the standard of care for the practice of a licensed respiratory care practitioner, the Board shall utilize the AARC’s National Clinical Practice Guidelines.</text> </paragraph> <paragraph num="B."> <text>If a particular practice issue has not yet been addressed in the AARC guidelines, the Board may consult with the Maryland/District of Columbia Society for Respiratory Care or any licensed respiratory care practitioner to determine whether a respiratory care practitioner being investigated by the Board is practicing within the acceptable standard of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Renewal, Reinstatement, and Continuing Education."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>The term of a license issued by the Board may not exceed 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(3)"> <text>An individual who has been licensed by the Board as a respiratory care practitioner may renew the license for an additional term on the date specified by the Board by:</text> <paragraph num="(a)"> <text>Completing an online renewal application on a form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee set by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to the completion of at least 16 hours of approved continuing respiratory care education, earned during the 2-year period preceding the expiration of the license for respiratory care, as described in §C of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Being of good moral character; and</text> </paragraph> <paragraph num="(e)"> <text>Meeting any additional renewal requirements set by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The continuing education requirement applies to all renewal applications after the first renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) of this regulation, the Board shall reinstate the license of a respiratory care practitioner if the respiratory care practitioner:</text> <paragraph num="(a)"> <text>Completes a reinstatement application on a form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Pays the required reinstatement fee and any other fees set by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Documents evidence of at least 16 hours of approved continuing education in the 2-year period preceding the date of the submission of the application for reinstatement, as described in §C of this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(e)"> <text>Completes a criminal history records check; and</text> </paragraph> <paragraph num="(f)"> <text>Meets any additional requirements set by the Board for reinstatement of a license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the license has not been renewed for more than 5 years and the applicant has not been practicing in another jurisdiction or country during at least 3 of the 5 years preceding the application, the applicant shall pass an examination approved by the Board, and meet all the requirements of licensure at the time the respiratory care practitioner applies for reinstatement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Continuing Education.</text> <paragraph num="(1)"> <text>Approved continuing respiratory care education includes:</text> <paragraph num="(a)"> <text>Programs accredited by or sponsored by one of the following organizations:</text> <paragraph num="(i)"> <text>Maryland/District of Columbia Society for Respiratory Care;</text> </paragraph> <paragraph num="(ii)"> <text>AARC’s Continuing Respiratory Care Education System; or</text> </paragraph> <paragraph num="(iii)"> <text>MedChi, the Maryland State Medical Society; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Other programs:</text> <paragraph num="(i)"> <text>Having requirements equivalent to the programs accredited through the organizations listed in §C(1)(a) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Instead of completing the required continuing education, an applicant for renewal or reinstatement may substitute passing the examination for either the certified respiratory therapist or registered respiratory therapist conducted by the National Certifying Board during the 2-year period preceding:</text> <paragraph num="(a)"> <text>For license renewal, the expiration of the license for respiratory care; or</text> </paragraph> <paragraph num="(b)"> <text>For license reinstatement, the date of the submission of the application for reinstatement.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A disciplinary panel may impose a civil penalty of up to $100 per continuing respiratory care education hour in lieu of a sanction under Health Occupations Article, §14–5A–17, Annotated Code of Maryland, for a first offense, for the failure of a licensee to obtain continuing education hours required by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Fees."> <text>The following fees are applicable to respiratory care practitioners:</text> <paragraph num="A."> <text>Initial licensure fee .— $200;</text> </paragraph> <paragraph num="B."> <text>License renewal fees:</text> <paragraph num="(1)"> <text>License renewal fee .— $150; and</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee .— As determined by MHCC under COMAR 10.25.02;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement fee .—. $200;</text> </paragraph> <paragraph num="D."> <text>Replacement of registration card .— $25;</text> </paragraph> <paragraph num="E."> <text>Replacement of wall license .—. $75; and</text> </paragraph> <paragraph num="F."> <text>Written verification fee .—. $25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Denials, Reprimands, Suspensions, and Revocations."> <paragraph num="A."> <text>Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, a disciplinary panel, on the affirmative vote of a majority of a quorum, may deny an application for licensure, renewal, or reinstatement, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant, licensee, or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of unprofessional or immoral conduct in the practice of respiratory care;</text> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(6)"> <text>Is habitually intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully makes or files a false report or record in the practice of respiratory care;</text> </paragraph> <paragraph num="(11)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report;</text> </paragraph> <paragraph num="(12)"> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="(13)"> <text>Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly makes a misrepresentation while practicing respiratory care;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly practices respiratory care with an unauthorized individual or aids an unauthorized individual in the practice of respiratory care;</text> </paragraph> <paragraph num="(16)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(17)"> <text>Is disciplined by a licensing or disciplinary authority, is convicted or disciplined by a court of any state or country, or is disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under the Board's disciplinary statutes;</text> </paragraph> <paragraph num="(18)"> <text>Fails to meet appropriate standards for the delivery of respiratory care performed in any:</text> <paragraph num="(a)"> <text>Inpatient or outpatient facility;</text> </paragraph> <paragraph num="(b)"> <text>Office;</text> </paragraph> <paragraph num="(c)"> <text>Hospital or related institution;</text> </paragraph> <paragraph num="(d)"> <text>Domiciliary care facility;</text> </paragraph> <paragraph num="(e)"> <text>Patient's home; or</text> </paragraph> <paragraph num="(f)"> <text>Other location in this State;</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Knowingly submits false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(20)"> <text>Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes and the licensed individual:</text> <paragraph num="(a)"> <text>Surrendered the license issued by the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(22)"> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(23)"> <text>Practices or attempts to practice beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(24)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(25)"> <text>Practices or attempts to practice a respiratory care procedure or uses or attempts to use respiratory care equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment;</text> </paragraph> <paragraph num="(26)"> <text>Fails to cooperate with a lawful investigation conducted by the Board; or</text> </paragraph> <paragraph num="(27)"> <text>Fails to practice under the supervision of a physician or violates a supervisory order of a supervising physician.</text> </paragraph> <paragraph num="(28)"> <text>Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearing. Except as otherwise provided in the Administrative Procedure Act, before the Board takes any action under §A of this regulation, the Board shall give the individual against whom the action is contemplated an opportunity for a hearing before the Board in accordance with the hearing requirements of Health Occupations Article, §14-405, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Crime Involving Moral Turpitude.</text> <paragraph num="(1)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5A-17(c), Annotated Code of Maryland, shall comply with COMAR 10.32.02.04.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Required Reports."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an employer of a licensed respiratory care practitioner shall report to the Board within 10 days of the action if the employer limits, reduces, or otherwise changes the responsibilities of or terminates a licensed respiratory care practitioner for any reason that might be grounds for disciplinary action under Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland, or any regulation in this chapter.</text> </paragraph> <paragraph num="B."> <text>If the action taken by an employer under §A of this regulation relates to alcohol or drug impairment, reporting shall comply with Health Occupations Article, §14-5A-18(b), (c), and (d), Annotated Code of Maryland and COMAR 10.32.22.</text> </paragraph> <paragraph num="C."> <text>A licensed respiratory care practitioner shall notify the licensed respiratory care practitioner's employer of a decision to enter an accredited alcohol or drug treatment program.</text> </paragraph> <paragraph num="D."> <text>An accredited alcohol or drug treatment program that is treating a licensed respiratory care practitioner who has given notice to his employer under §C of this regulation shall notify the employer if the licensed respiratory care practitioner is found to be noncompliant with the treatment program's policies and procedures.</text> </paragraph> <paragraph num="E."> <text>An individual is not required to make a report under this regulation that would be in violation of a federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Penalties, Fines and Sanctioning Guidelines."> <paragraph num="A."> <text>An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000, or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>A disciplinary panel may impose a civil fine of not more than $5,000 on an individual who:</text> <paragraph num="(1)"> <text>Is not licensed to practice respiratory care in Maryland and represents to the public in any way that the individual is authorized to practice respiratory care in Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Violates any provision of Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall deposit a penalty collected under §B of this regulation into the Board of Physicians fund.</text> </paragraph> <paragraph num="D."> <text>Employment of Unauthorized Individuals.</text> <paragraph num="(1)"> <text>A licensed physician, hospital, related institution, alternative health system, or employer may not employ an individual practicing respiratory care without a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensed physician may not supervise an individual practicing respiratory care without a license.</text> </paragraph> <paragraph num="(3)"> <text>A disciplinary panel may impose a fine of up to $1,000 for a violation of §D(1) or (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Any funds collected under §D(3) of this regulation shall be deposited into the General Fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to Make a Required Report.</text> <paragraph num="(1)"> <text>A disciplinary panel may impose a fine up to $1,000 for a hospital, related institution, alternative health system, or employer who fails to make a report to the Board required by Regulation .14 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall deposit any funds collected under §E(1) of this regulation into the General Fund.</text> </paragraph> </paragraph> <paragraph num="F."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections F and G of this regulation and Regulation .16 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B of this regulation, for violations of the sections of the Maryland Respiratory Care Practitioners Act listed in the sanctioning guidelines, a disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(d)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. If a minimum fine is listed, at least the minimum fine shall be imposed in addition to the sanction listed.</text> </paragraph> <paragraph num="(e)"> <text>The addition of a fine does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>A disciplinary panel may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .16 of this chapter, in order to resolve a pending disciplinary action, a disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by a disciplinary panel, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If a disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .16 of this chapter, a disciplinary panel shall state its reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .16 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> </paragraph> <paragraph num="H."> <text>In addition to any sanction authorized under this regulation, a disciplinary panel may require a licensee to comply with specified terms and conditions determined by a disciplinary panel.</text> </paragraph> <paragraph num="I."> <text>A disciplinary panel may impose a fine of $100 for a violation of Health Occupations Article, §14-5A-14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="J."> <text>Offenses Related to Continuing Education Credits.</text> <paragraph num="(1)"> <text>First Offense of Failure to Document Credits.</text> <paragraph num="(a)"> <text>Except as provided in §I(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5A-13, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5A-17, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Section I(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5A-17(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5A-17(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5A-17(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5A-17, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Licensees Previously Disciplined Under §I(1) or (2) of this Regulation.</text> <paragraph num="(a)"> <text>If a licensee has been previously fined or otherwise disciplined under §I(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing education credits, charge a licensee under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5A-17(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5A-17(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5A-17(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5A-17, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(c)"> <text>The Board may not apply the sanction described in §J(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing education credits.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall pay all monies collected pursuant to §I of this regulation into the Board of Physicians Fund.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Sanctioning Guidelines for Respiratory Care Practitioners."> <paragraph num="A."> <text>Subject to provisions of Regulation .15F and G of this chapter, the Board may impose sanctions as outlined in §B of this regulation on respiratory care practitioners for violations of Health Occupations Article, §14-5A-17(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213, 1-606, 14-205(a), 14-5A, and 14-5C-03, Annotated Code of Maryland;Ch. 328, Acts of 2008</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06, .08, and .09 adopted effective November 11, 1991 (18:22 Md. R. 2396)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 25, 1994 (21:8 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 1, 1994 (21:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective April 25, 1994 (21:8 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective February 17, 1992 (19:3 Md. R. 305)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Certification of Respiratory Care Practitioners, repealed and new chapter, Licensing of Respiratory Care Practitioners, adopted effective August 25, 1997 (24:17 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 14, 2005 (32:3 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); repealed permanently effective November 3, 2008 (35:22 Md. R. 1957)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); repealed permanently effective November 3, 2008 (35:22 Md. R. 1957)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); amended permanently effective November 3, 2008 (35:22 Md. R. 1957)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed and new Regulation .12 adopted effective February 14, 2005 (32:3 Md. R. 290)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); amended permanently effective November 3, 2008 (35:22 Md. R. 1957)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective August 19, 2002 (29:16 Md. R. 1288)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 7, 2011 (38:5 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01E adopted effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, C amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, E adopted effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective January 2, 2017 (43:26 Md. R. 1446); January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective July 22, 2013 (40:14 Md. R. 1176); January 19, 2026 (53:1 Md. R. 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 adopted effective July 22, 2013 (40:14 Md. R. 1176)</annotation> </annotations> </chapter> <chapter num="12" heading="Delegation of Acts by a Licensed Physician"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the delegation of technical acts by a licensed physician to an:</text> <paragraph num="(1)"> <text>Assistant not otherwise authorized under the Health Occupations Article or the Education Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>RCIS assisting in the physician's performance of fluoroscopy during a cardiac catheterization procedure under certain circumstances as authorized under Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter may not be construed:</text> <paragraph num="(1)"> <text>As establishing the licensure, certification, or registration by the Board of assistants or registered cardiovascular invasive specialists;</text> </paragraph> <paragraph num="(2)"> <text>To apply to certified, registered, or licensed professionals, or health occupation students acting pursuant to Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>To mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assistant” means an individual to whom only routine technical acts are delegated by a licensed physician and who is:</text> <paragraph num="(a)"> <text>Trained as defined in §B(17) of this regulation and not certified, registered, or licensed by the Board or any other State health occupation board; or</text> </paragraph> <paragraph num="(b)"> <text>Certified, registered, or licensed by the Board or any other State health occupation board and is not acting under the authority of that certification, registration, or license granted by a State health occupation board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. §263a) and the regulations promulgated under them, and 42 CFR Part 493, Subparts B and M.</text> </paragraph> <paragraph num="(4)"> <text>“Delegating physician” means a physician possessing an active license to practice medicine in this State who directs an assistant or RCIS to perform technical acts.</text> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means oversight exercised by a delegating physician who is:</text> <paragraph num="(a)"> <text>Personally treating the patient; and</text> </paragraph> <paragraph num="(b)"> <text>In the presence of the patient and the:</text> <paragraph num="(i)"> <text>Assistant; or</text> </paragraph> <paragraph num="(ii)"> <text>RCIS.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Fluoroscopy” means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images.</text> </paragraph> <paragraph num="(7)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed physician” means, unless the context requires otherwise, a physician, including a doctor of osteopathy, who is licensed by the Board to practice medicine.</text> </paragraph> <paragraph num="(9)"> <text>“MDE” means the Maryland Department of the Environment.</text> </paragraph> <paragraph num="(10)"> <text>“Microdermabrasion” means the use of a minimally invasive technique to gently exfoliate the dead, outermost layer of skin and is a method for improving superficial, environmental, aging, and hereditary skin changes by superficial, mechanically powered abrasion, often combined with application of topical crystals such as vitamin C.</text> </paragraph> <paragraph num="(11)"> <text>“On-site supervision” means oversight exercised by a delegating physician who is present at the site and able to be immediately available in person during the course of the performance of a delegated act.</text> </paragraph> <paragraph num="(12)"> <text>“Perform fluoroscopy” means the energizing of a fluoroscopic x-ray system by an individual authorized in accordance with MDE regulations.</text> </paragraph> <paragraph num="(13)"> <text>“Readily retrievable” means maintained in a method by which a hospital can retrieve and produce the record for the Board upon request.</text> </paragraph> <paragraph num="(14)"> <text>“Registered cardiovascular invasive specialist (RCIS)” means an individual who is credentialed by Cardiovascular Credentialing International or another credentialing body approved by the Board to assist in cardiac catheterization procedures under the direct, in-person supervision of a licensed physician.</text> </paragraph> <paragraph num="(15)"> <text>“Site” means any facility or location including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health services not covered in this chapter.</text> </paragraph> <paragraph num="(16)"> <text>“Technical act” means a routine medical or surgical act which does not require medical judgment and is performed with the supervision as specified within this chapter.</text> </paragraph> <paragraph num="(17)"> <text>“Trained” means possessing the knowledge, skills, and abilities, as determined by the licensed physician, to perform delegated acts.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards for the Licensed Physician Delegating to an Assistant."> <paragraph num="A."> <text>A licensed physician who delegates shall:</text> <paragraph num="(1)"> <text>Evaluate the risk to the patient and the outcome of the delegated acts;</text> </paragraph> <paragraph num="(2)"> <text>Delegate only those technical acts that are customary to the practice of the licensed physician;</text> </paragraph> <paragraph num="(3)"> <text>Delegate only those technical acts for which the assistant has been trained;</text> </paragraph> <paragraph num="(4)"> <text>Be responsible for the acts of the assistant; and</text> </paragraph> <paragraph num="(5)"> <text>Supervise the assistant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The responsibility for the delegated act cannot be transferred from the delegating physician to another licensed physician without:</text> <paragraph num="(1)"> <text>The expressed consent of the other physician; and</text> </paragraph> <paragraph num="(2)"> <text>Informing the assistant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Delegation to an Assistant."> <paragraph num="A."> <text>A licensed physician may not delegate to an assistant technical acts which are exclusively limited to any individual required to be licensed, certified, registered, or otherwise recognized pursuant to any provision of the Health Occupations Article and the Education Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A licensed physician may delegate technical acts consistent with national standards in the medical community and the approved policies and procedures of the sites for the delivery of health services in the following categories:</text> <paragraph num="(1)"> <text>Surgical technical acts that the delegating physician directly orders while present, scrubbed, and personally performing the surgery in the same surgical field; and</text> </paragraph> <paragraph num="(2)"> <text>Nonsurgical technical acts while the assistant is under the licensed physician's direct supervision or on-site supervision if the assistant performs the act in accordance with procedures of the site.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At sites included in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, or any unit of those sites, a licensed physician may delegate technical acts in compliance with State regulations and the policies, procedures, and supervisory structures of those sites.</text> </paragraph> <paragraph num="D."> <text>At sites not included in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, when providing the following specified levels of supervision, a licensed physician may delegate to an assistant technical acts which include but are not limited to:</text> <paragraph num="(1)"> <text>Without on-site supervision:</text> <paragraph num="(a)"> <text>Patient preparation for physician examination;</text> </paragraph> <paragraph num="(b)"> <text>Patient history interview;</text> </paragraph> <paragraph num="(c)"> <text>Collecting and processing specimens, such as performing phlebotomy and inoculating culture media;</text> </paragraph> <paragraph num="(d)"> <text>Preparation of specimens for selected tests including:</text> <paragraph num="(i)"> <text>Pregnancy tests;</text> </paragraph> <paragraph num="(ii)"> <text>Dipstick and microscopic urinalysis; and</text> </paragraph> <paragraph num="(iii)"> <text>Microbiology (rapid streptococcal testing and throat cultures);</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Laboratory tests that the licensed physician is satisfied the assistant is qualified to perform under State and CLIA regulations;</text> </paragraph> <paragraph num="(f)"> <text>Clinical tests such as:</text> <paragraph num="(i)"> <text>Application of tuberculin skin tests;</text> </paragraph> <paragraph num="(ii)"> <text>Electrocardiography;</text> </paragraph> <paragraph num="(iii)"> <text>Administering basic pulmonary function tests; and</text> </paragraph> <paragraph num="(iv)"> <text>Visual field tests;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Transmitting prescriptions to a pharmacy;</text> </paragraph> <paragraph num="(h)"> <text>Providing sample packets of medication, selected by a licensed physician who is physically present at the time of selection, to patients as directed by the delegating physician and in conformance with Health Occupations Article, §12-102(a), (d), and (f), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(i)"> <text>Preparing and administering oral drugs; and</text> </paragraph> <paragraph num="(j)"> <text>Microdermabrasion;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>With on-site supervision:</text> <paragraph num="(a)"> <text>Preparing and administering injections limited to intradermal, subcutaneous, and intramuscular (deltoid, gluteal, vastus lateralis) to include small amounts of local anesthetics;</text> </paragraph> <paragraph num="(b)"> <text>Establishing a peripheral intravenous line; and</text> </paragraph> <paragraph num="(c)"> <text>Injecting fluorescein-like dyes for retinal angiography; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>With direct supervision, injecting intravenous drugs or contrast materials.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensed physician who possesses a dispensing permit may delegate the dispensing functions in accordance with the requirements of COMAR 10.32.23.</text> </paragraph> <paragraph num="F."> <text>A licensed physician may not delegate to an assistant acts which include but are not limited to:</text> <paragraph num="(1)"> <text>Conducting physical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics;</text> </paragraph> <paragraph num="(3)"> <text>Initiating independently any form of treatment, exclusive of cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(4)"> <text>Giving medical advice without the consult of a licensed physician; and</text> </paragraph> <paragraph num="(5)"> <text>Providing physical therapy.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Prohibited Conduct and Penalties."> <paragraph num="A."> <text>An assistant or RCIS acting beyond the scope of this chapter may be:</text> <paragraph num="(1)"> <text>Considered to be engaged in the unlicensed practice of medicine; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-602 and 14-607, Annotated Code of Maryland, and COMAR 10.32.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A delegating physician, through either act or omission, facilitation, or otherwise enabling or forcing an assistant or RCIS to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §14-404(a), Annotated Code of Maryland, including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine.</text> </paragraph> <paragraph num="C."> <text>A delegating physician may not:</text> <paragraph num="(1)"> <text>Require an assistant or RCIS to perform a delegated act; or</text> </paragraph> <paragraph num="(2)"> <text>Permit an assistant or RCIS to delegate any act to another individual.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A hospital that fails to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter may be assessed a civil penalty of up to $5,000 for each instance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="RCIS Assistance in the Delegating Physician’s Performance of Fluoroscopy."> <paragraph num="A."> <text>Scope of Regulation.</text> <paragraph num="(1)"> <text>This regulation governs:</text> <paragraph num="(a)"> <text>A licensed physician’s delegation of technical acts to an RCIS assisting in the physician’s performance of fluoroscopy provided the delegation is in accordance with the entirety of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>The responsibilities of the hospital in which the cardiac catheterization laboratory is located to verify and document the qualifications of an RCIS and to ensure that all requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this regulation are met for each procedure.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>This regulation does not limit a licensed physician from delegating technical acts to an RCIS who is not assisting in the physician’s performance of fluoroscopy provided the delegation is in accordance with Regulations .01—.05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An RCIS assisting in a delegating physician’s performance of fluoroscopy shall:</text> <paragraph num="(1)"> <text>Possess an active RCIS certification issued by Cardiovascular Credentialing International or another credentialing body approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Complete 40 hours of:</text> <paragraph num="(a)"> <text>Accredited didactic education in fluoroscopic radiation physics and fluoroscopic patient safety; and</text> </paragraph> <paragraph num="(b)"> <text>Clinical fluoroscopic training supervised by a radiologist, radiographer, or radiologist assistant who is physically present in the room with the RCIS to instruct the clinical fluoroscopic training;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the hospital, wear an identification badge displaying in readily visible type:</text> <paragraph num="(a)"> <text>The name of the RCIS; and</text> </paragraph> <paragraph num="(b)"> <text>A designation by the hospital of verification of the RCIS’ credentials and completion of requirements to assist in a physician’s performance of fluoroscopy; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Comply with any additional requirements as established by:</text> <paragraph num="(a)"> <text>MDE;</text> </paragraph> <paragraph num="(b)"> <text>The Joint Commission; and</text> </paragraph> <paragraph num="(c)"> <text>Federal and State laws and regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Responsibilities.</text> <paragraph num="(1)"> <text>The hospital shall:</text> <paragraph num="(a)"> <text>Verify that the RCIS has met the requirements in §B of this regulation before permitting an RCIS to assist in a delegating physician’s performance of fluoroscopy;</text> </paragraph> <paragraph num="(b)"> <text>Issue to the RCIS an identification badge in accordance with §B(3) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Keep on-site all documentation of the RCIS’ certification and the additional training required under this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Permit the Board, at any reasonable hour, to inspect the hospital’s documentation of the RCIS’ certification and training to ensure compliance with this regulation;</text> </paragraph> <paragraph num="(e)"> <text>Regarding radiation machines and fluoroscopy services, comply with any additional requirements as established by:</text> <paragraph num="(i)"> <text>MDE;</text> </paragraph> <paragraph num="(ii)"> <text>The Joint Commission; and</text> </paragraph> <paragraph num="(iii)"> <text>Federal and State laws and regulations; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Verify that the acts delegated to the RCIS are in accordance with the scope of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The delegating physician shall:</text> <paragraph num="(a)"> <text>Exercise direct supervision of the RCIS when the RCIS is assisting the delegating physician in the delegating physician’s performance of fluoroscopy;</text> </paragraph> <paragraph num="(b)"> <text>Delegate only technical acts involved in the physician’s performance of fluoroscopy in accordance with Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Verbally direct each technical act performed by the RCIS.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The RCIS:</text> <paragraph num="(a)"> <text>May not perform fluoroscopy;</text> </paragraph> <paragraph num="(b)"> <text>Shall perform technical acts to assist the delegating physician in the delegating physician’s performance of fluoroscopy only upon verbal direction from the delegating physician;</text> </paragraph> <paragraph num="(c)"> <text>May not delegate any act to another individual; and</text> </paragraph> <paragraph num="(d)"> <text>May not engage in prohibited conduct as set out in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Enforcement."> <paragraph num="A."> <text>The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="B."> <text>Any matter regarding a hospital’s failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and Regulation .06 of this chapter shall be adjudicated in accordance with COMAR 10.32.02.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §§19-114 and 19-118; Health Occupations Article, §§14-205(a) and 14-306; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 12, 2000 (27:11 Md. R. 1078)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 2, 2002 (29:17 Md. R. 1380); March 14, 2016 (43:5 Md. R. 386); December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 2, 2002 (29:17 Md. R. 1380); December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective March 14, 2016 (43:5 Md. R. 386)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E, F amended effective March 26, 2018 (45:6 Md. R. 320)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective December 27, 2021 (48:26 Md. R. 1112)</annotation> </annotations> </chapter> <chapter num="13" heading="Physician License by Conceded Eminence"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish the qualifications for an individual to become licensed in Maryland to practice medicine by virtue of conceded eminence and authority in the profession and to set limits on the license.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ABMS or other equivalent specialty board” means the American Board of Medical Specialties or equivalent boards in other countries.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual applying for initial licensure as a physician in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Application period” means the time between the filing of an application and the issuance of a license or denial of the application.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(5)"> <text>“Conceded eminence and authority in the profession” means significant teaching, research, and achievement in a field of medicine recognized by the Board.</text> </paragraph> <paragraph num="(6)"> <text>“First author” means the first named author of a publication such as a research article or the author who served as the principal investigator for a research project.</text> </paragraph> <paragraph num="(7)"> <text>“Index Medicus” means an international list of periodicals concerning the practice of medicine.</text> </paragraph> <paragraph num="(8)"> <text>“Last author” means the last named author of a publication such as a research article or the senior author who served as the principal investigator for a research project.</text> </paragraph> <paragraph num="(9)"> <text>“LCME” means Liaison Committee on Medical Education of the American College of Medical Education and the American Medical Association.</text> </paragraph> <paragraph num="(10)"> <text>“LMCC” means Licentiate of the Medical Council of Canada, or its successor.</text> </paragraph> <paragraph num="(11)"> <text>“Malpractice history” means a list of claims filed against a health care provider for damage due to medical injuries as described in Courts and Judicial Proceedings Article, Title 3, Subtitle 2A, Annotated Code of Maryland, or adverse action reports made to the National Practitioner Data Bank of the federal government, or both.</text> </paragraph> <paragraph num="(12)"> <text>“Medical licensing examination results” means scores or results of examinations such as the:</text> <paragraph num="(a)"> <text>Educational Commission for Foreign Medical Graduates (ECFMG), or its successor;</text> </paragraph> <paragraph num="(b)"> <text>Federation Licensing Examination (FLEX) designed by the Federation of State Medical Boards;</text> </paragraph> <paragraph num="(c)"> <text>National Board of Medical Examiners (NBME);</text> </paragraph> <paragraph num="(d)"> <text>United States Medical Licensing Examination (USMLE) designed by the Federation of State Medical Boards; and</text> </paragraph> <paragraph num="(e)"> <text>Special Purpose Examination prepared by the Federation of State Medical Boards (SPEX).</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Postgraduate training” means, for the purpose of conceded eminence applicants, clinical and medical training for medical school graduates, including but not limited to, internships, residencies, and fellowships.</text> </paragraph> <paragraph num="(14)"> <text>“Speech impairment” means a disorder of the voice, in articulation of speech sounds, or nonfluency in the speaker's native language.</text> </paragraph> <paragraph num="(15)"> <text>“World Health Organization directory” means the World Directory of Medical Schools, an international list of recognized medical schools compiled by the World Health Organization agency of the United Nations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications for Special License by Conceded Eminence."> <paragraph num="A."> <text>An applicant shall:</text> <paragraph num="(1)"> <text>Complete an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay an application fee set by the Board in COMAR 10.32.01.12;</text> </paragraph> <paragraph num="(3)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(4)"> <text>Be at least 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Recommendations. On a form supplied by the Board, the dean of a school of medicine in the State or the director of the National Institutes of Health shall recommend the applicant to the Board, by:</text> <paragraph num="(1)"> <text>Attesting to the fact that the applicant is to receive an appointment at the institution represented by the dean or director;</text> </paragraph> <paragraph num="(2)"> <text>Presenting the Board with detailed evidence of the physician’s qualifications and competence including:</text> <paragraph num="(a)"> <text>The nature of the physician's proposed responsibilities;</text> </paragraph> <paragraph num="(b)"> <text>Reasons for any limitations of the physician's practice responsibilities; and</text> </paragraph> <paragraph num="(c)"> <text>The degree of supervision under which the physician will function; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Presenting the Board with a detailed statement describing the applicant’s conceded eminence and authority in the profession.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Evidence of Teaching, Research, and Achievement. An applicant shall demonstrate eminence and authority in the profession by meeting the following qualifications:</text> <paragraph num="(1)"> <text>Have held an appointment at a medical school approved by the LCME or at any medical school listed in the World Health Organization directory at the level of associate or full professor, or its equivalent, for at least 5 years;</text> </paragraph> <paragraph num="(2)"> <text>Have actively practiced medicine cumulatively for 10 years after completion of postgraduate training, including clinical research;</text> </paragraph> <paragraph num="(3)"> <text>Be a member in good standing of a board of the American Board of Medical Specialties or other equivalent specialty board;</text> </paragraph> <paragraph num="(4)"> <text>Possess a current, active, unrestricted license to practice medicine in another state or country, or be otherwise recognized under the laws of the other country or jurisdiction as a medical doctor in that jurisdiction; and</text> </paragraph> <paragraph num="(5)"> <text>Within 10 years before the application:</text> <paragraph num="(a)"> <text>Have:</text> <paragraph num="(i)"> <text>Published original results of clinical research, as first author or last author, in a medical journal listed in the Index Medicus or in an equivalent scholarly publication acceptable to the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>Submitted these articles to the Board in English or in a foreign language with verifiable, certified translations in English; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Have developed a treatment modality, surgical technique, or other verified original contribution to the field of medicine, which is attested to by the dean of a school of medicine in the State or by the director of the National Institutes of Health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Supervision. The Board shall require an applicant to submit:</text> <paragraph num="(1)"> <text>The name of a licensed physician who will supervise the medical services provided by the applicant for the first 6 months of practice; and</text> </paragraph> <paragraph num="(2)"> <text>A detailed description of the medical services, duties, and responsibilities that the applicant will perform.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Additional Requirements for License by Conceded Eminence and Authority in the Profession.</text> <paragraph num="(1)"> <text>The Board may require additional information which includes, but is not limited to, the following:</text> <paragraph num="(a)"> <text>A letter from the chief of staff of any hospital where the applicant has practiced within the 5 years preceding the application for license under this chapter, detailing the applicant's competence to practice medicine;</text> </paragraph> <paragraph num="(b)"> <text>A detailed description of activities including, but not limited to, the following:</text> <paragraph num="(i)"> <text>Any action, by any state licensing or disciplinary board, or any comparable body in the armed services, denying an application for licensure, reinstatement, or renewal;</text> </paragraph> <paragraph num="(ii)"> <text>Any action taken against the physician's license, by any state licensing or disciplinary board, or any comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Any investigations or charges brought against the physician by any licensing or disciplinary body or comparable body in the armed services;</text> </paragraph> <paragraph num="(iv)"> <text>Any medical or health professional licenses for which the physician has applied when the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>Any investigations or charges brought against the physician by any hospital, related institution, or alternative health care system that might be grounds for action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>Any limitations or loss in privileges by any hospital, related health care facility, or alternative health care system that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vii)"> <text>Any pleas of guilty or nolo contendere, or convictions, or receipt of probation before judgment for any criminal act;</text> </paragraph> <paragraph num="(viii)"> <text>Any pleas of guilty or nolo contendere, or convictions, or receipt of probation before judgment for any alcohol or controlled dangerous substance offense including, but not limited to, driving while under the influence of alcohol or controlled dangerous substances;</text> </paragraph> <paragraph num="(ix)"> <text>Any arrests which would provide a basis for investigation or charges that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(x)"> <text>Any illness or condition which has impaired the physician's ability to practice medicine within the 3 years before, or during the pendency of, the application;</text> </paragraph> <paragraph num="(xi)"> <text>Any treatment for alcohol abuse, substance abuse, or chemical dependence; and</text> </paragraph> <paragraph num="(xii)"> <text>The filing or settling of any medical malpractice actions in which the physician is, or has been, named as a defendant;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Malpractice history;</text> </paragraph> <paragraph num="(d)"> <text>Driving record, including but not limited to convictions for driving while intoxicated or while under the influence of any chemical substance or medication;</text> </paragraph> <paragraph num="(e)"> <text>Medical licensing examination results;</text> </paragraph> <paragraph num="(f)"> <text>Physical or mental examinations, or both, by a physician or evaluation program for treatment of impaired physicians, or both, chosen by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On forms supplied by the Board, an applicant shall:</text> <paragraph num="(a)"> <text>Agree to release to the Board information from other institutions and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies; and</text> </paragraph> <paragraph num="(b)"> <text>Allow the Board to release information which is not statutorily protected.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant for licensure under this chapter shall agree to inform the Board by certified mail, return receipt requested, within 30 days of receiving notice of any action listed in this section.</text> </paragraph> </paragraph> <paragraph num="F."> <text>English Language Competency. An applicant shall demonstrate oral and written English language competency as described in COMAR 10.32.01.04D.</text> </paragraph> <paragraph num="G."> <text>Claim of Speech Impairment. An applicant wishing to claim a speech impairment shall submit documentation of this impairment on forms supplied by the Board as described in COMAR 10.32.01.04E.</text> </paragraph> <paragraph num="H."> <text>Withdrawals. An application may not be withdrawn if the applicant is under investigation or charges for reasons that may be grounds under Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Limited Practice."> <text>An applicant for licensure is restricted so that the applicant shall:</text> <paragraph num="A."> <text>Practice medicine only in the limited field approved by the Board that is consistent with the applicant’s area of conceded eminence experience;</text> </paragraph> <paragraph num="B."> <text>For the first 6 months of practice, practice medicine only:</text> <paragraph num="(1)"> <text>Within the institution and program specified within the application; and</text> </paragraph> <paragraph num="(2)"> <text>Under the supervision of a licensed physician;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Following the first 6 months of practice, practice medicine only:</text> <paragraph num="(1)"> <text>At an institution similar to that named in the original application; and</text> </paragraph> <paragraph num="(2)"> <text>After approval by the Board; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Practice medicine under any conditions which the Board may set.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Unrestricted License."> <text>Nothing in these regulations entitles an individual licensed by conceded eminence in the profession to practice beyond the scope of these regulations without having qualified for an unrestricted license under Health Occupations Article, §14-307 or 14-308, Annotated Code of Maryland, and regulations promulgated under those sections.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Term and Renewal of License by Conceded Eminence and Authority in the Profession."> <paragraph num="A."> <text>Term and Tenure.</text> <paragraph num="(1)"> <text>The initial license is active for a period 1 year, and, after that, may be renewed twice for a term established by the Board. After two renewals, a licensee seeking any additional renewals shall provide documentation to the Board 3 months before the expiration of the licensee’s license indicating the continued significance of the licensee’s work at the sponsoring institution that requires the license to be renewed for another term.</text> </paragraph> <paragraph num="(2)"> <text>Unless the Board has been advised and approves of an appointment at a new institution, a license issued under this regulation expires immediately when an individual leaves the appointment at the sponsoring institution.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Initial Renewal. As part of the initial renewal process:</text> <paragraph num="(1)"> <text>The supervising physician shall submit an attestation, approved by the Board, that the licensee was supervised for a period of at least 6 consecutive months; and</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall complete a renewal application form, after Board approval of the attestation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Second Renewal.</text> <paragraph num="(1)"> <text>A license issued under this chapter may be renewed in a second renewal:</text> <paragraph num="(a)"> <text>On a date set by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>As specified in COMAR 10.32.01.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee for second renewal shall:</text> <paragraph num="(a)"> <text>Complete a renewal application form;</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements set out in COMAR 10.32.01.10, including completing at least 50 hours of continuing medical education units; and</text> </paragraph> <paragraph num="(c)"> <text>Pay a renewal fee set by the Board in COMAR 10.32.01.12.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee shall inform the Board of the institution where the licensee plans on practicing for the renewal term.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subsequent Renewal.</text> <paragraph num="(1)"> <text>A license issued under this chapter may be renewed in subsequent renewals:</text> <paragraph num="(a)"> <text>On a date set by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>As specified in COMAR 10.32.01.12.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A license for subsequent renewal shall:</text> <paragraph num="(a)"> <text>Complete a renewal application form;</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements set out in COMAR 10.32.01.10, including completing at least 50 hours of continuing medical education units;</text> </paragraph> <paragraph num="(c)"> <text>Provide documentation to the Board 3 months before the expiration of the licensee’s license indicating the continued significance of the licensee’s work at the sponsoring institution that requires the license to be renewed for another term; and</text> </paragraph> <paragraph num="(d)"> <text>Pay a renewal fee set by the Board in COMAR 10.32.01.12.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee shall inform the Board of the institution where the licensee plans on practicing for the renewal term.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensure Required."> <text>Practicing medicine beyond the scope of these regulations, including practicing without notifying the Board and without approval of the Board at any institution or place outside the institution approved by the Board, constitutes practicing without a license under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Termination and New Appointment."> <paragraph num="A."> <text>On termination of the licensee’s approved appointment, the conceded eminence license terminates and becomes null and void.</text> </paragraph> <paragraph num="B."> <text>A licensee has a duty to inform the Board of the termination of an appointment within 30 days of the termination.</text> </paragraph> <paragraph num="C."> <text>Failure of the licensee to inform the Board of the termination of an appointment within 30 days constitutes unprofessional conduct under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>New Appointment.</text> <paragraph num="(1)"> <text>If a licensee wishes to receive a conceded eminence license with another institution, the licensee shall apply for a new appointment with another institution.</text> </paragraph> <paragraph num="(2)"> <text>The Board may approve the new appointment at the Board’s discretion.</text> </paragraph> <paragraph num="(3)"> <text>Board approval shall be obtained before the individual may begin the appointment.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-205, 14-206, 14-301, 14-302, and 14-307—319, Annotated Code of Maryland; Chapter 273 (1993)</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 22, 1993 (20:23 Md. R. 1804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 1, 2018 (44:26 Md. R. 1215); October 22, 2018 (45:21 Md. R. 975); August 26, 2019 (46:17 Md. R. 727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215); October 22, 2018 (45:21 Md. R. 975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> </annotations> </chapter> <chapter num="14" heading="Unlicensed Limited X-Ray Machine Operator"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the performance of certain X-ray duties without a license to a registered Limited X-ray Machine Operator.</text> </paragraph> <paragraph num="B."> <text>This chapter may not be construed to:</text> <paragraph num="(1)"> <text>Apply to certified, registered, or licensed professionals or health occupation students acting pursuant to Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ARRT” means American Registry of Radiologic Technologists.</text> </paragraph> <paragraph num="(2)"> <text>“Authorized supervisor” means a Maryland licensed physician or a Maryland licensed radiologic technologist.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(4)"> <text>“Certified radiologic technologist” means an individual who holds an active license and is certified in radiologic technology by the ARRT.</text> </paragraph> <paragraph num="(5)"> <text>“Competency” means the successful completion of supervised clinical procedures to verify the individual’s professional knowledge, skills, and ability.</text> </paragraph> <paragraph num="(6)"> <text>“Direct supervision” means oversight exercised by an authorized supervisor who is in the physical presence of the unlicensed individual and is able to provide instruction during the performance of an X-ray procedure.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed physician” means, unless the context requires otherwise, a physician, including a doctor of osteopathy, licensed by the Board to practice medicine in the State.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed radiologic technologist” means, unless the context requires otherwise, an individual licensed by the Board as a radiographer in the State.</text> </paragraph> <paragraph num="(9)"> <text>Limited Scope X-ray Educational Program.</text> <paragraph num="(a)"> <text>“Limited scope X-ray educational program” means an educational program that meets the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Limited scope X-ray educational program” is not a radiography educational program.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“LXMO” means a Limited X-Ray Machine Operator registered with the Board.</text> </paragraph> <paragraph num="(11)"> <text>“Immediately available supervision" means oversight exercised by an authorized supervisor who can be immediately available to provide direction in person, by telephone, or by other electronic means.</text> </paragraph> <paragraph num="(12)"> <text>“Readily retrievable” means maintained in a method by which an office can retrieve and produce the record for the Board upon request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application, Renewal, and Reinstatement."> <paragraph num="A."> <text>To apply for LXMO registration, an applicant shall:</text> <paragraph num="(1)"> <text>Pay the fee determined by the Board established in Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Complete a form provided by the Board attesting to:</text> <paragraph num="(a)"> <text>Completion of at least 6 months of clinical care experience;</text> </paragraph> <paragraph num="(b)"> <text>Completion of a limited scope X-ray educational program consisting of at least 115 hours of didactic training delivered by a certified radiologic technologist providing instruction in:</text> <paragraph num="(i)"> <text>Radiographic anatomy, procedures, and pathology;</text> </paragraph> <paragraph num="(ii)"> <text>Digital image acquisition and display;</text> </paragraph> <paragraph num="(iii)"> <text>Fundamentals, ethics, and laws of health care;</text> </paragraph> <paragraph num="(iv)"> <text>Human anatomy and physiology;</text> </paragraph> <paragraph num="(v)"> <text>Image production and analysis;</text> </paragraph> <paragraph num="(vi)"> <text>Imaging equipment and radiation production;</text> </paragraph> <paragraph num="(vii)"> <text>Medical terminology; and</text> </paragraph> <paragraph num="(viii)"> <text>Patient care;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Completion of at least 480 hours of clinical training performed under the direct supervision of a certified radiologic technologist;</text> </paragraph> <paragraph num="(d)"> <text>Completion of a minimum of five competencies in each body part listed in Regulation .06B(2) of this chapter performed under the direct supervision of a certified radiologic technologist; and</text> </paragraph> <paragraph num="(e)"> <text>Achievement of a passing result of 75 percent or higher on the ARRT Examination for Limited Scope of Practice in Radiography or a passing result on an alternative exam as determined by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Criminal History Records Check. An applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository:</text> <paragraph num="(a)"> <text>Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the Federal Bureau of Investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal.</text> <paragraph num="(1)"> <text>Before the expiration of the registration, an individual applying for renewal shall complete an application for renewal on the form supplied by the Board.</text> </paragraph> <paragraph num="(2)"> <text>LXMO registration shall be renewed every 2 years on the date set by the Board.</text> </paragraph> <paragraph num="(3)"> <text>An LXMO shall pay the renewal fee, and any additional charges set by the Board in accordance with Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>An LXMO shall attest to the completion of continuing education activities as specified in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>The Board may request an LXMO to submit evidence of having met the continuing education requirement specified in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>If an LXMO cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education hour.</text> </paragraph> <paragraph num="(7)"> <text>If an LXMO fails to renew their registration for any reason, the registration will expire.</text> </paragraph> <paragraph num="(8)"> <text>After the expiration of the registration, an individual is no longer authorized to practice as an LXMO.</text> </paragraph> <paragraph num="(9)"> <text>The Board may impose a civil penalty of up to $1,000 on the individual and a civil penalty of up to $5,000 on the employer of the individual for practicing without registration if a formerly registered individual:</text> <paragraph num="(a)"> <text>Fails to submit an application and pay the requisite renewal fee before the expiration of the registration; and</text> </paragraph> <paragraph num="(b)"> <text>Practices as a LXMO after the expiration of the registration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>The Board shall reinstate the registration of an LXMO if the individual:</text> <paragraph num="(a)"> <text>Completes the reinstatement application on the form approved by the Board.</text> </paragraph> <paragraph num="(b)"> <text>Pays a reinstatement fee as determined by the Board in accordance with Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Documents evidence of completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement for the registration as an LXMO.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository:</text> <paragraph num="(a)"> <text>Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the Federal Bureau of Investigation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Continuing Education."> <paragraph num="A."> <text>An LXMO shall complete at least 24 hours of approved continuing education credits earned during the 2 years preceding the expiration of the registration.</text> </paragraph> <paragraph num="B."> <text>Approved continuing education is as follows:</text> <paragraph num="(1)"> <text>In-service programs at a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a health maintenance organization certified by the State; or</text> </paragraph> <paragraph num="(2)"> <text>Programs relevant to the practice of an LXMO approved by the:</text> <paragraph num="(a)"> <text>Maryland Society of Radiologic Technologists;</text> </paragraph> <paragraph num="(b)"> <text>American Medical Association;</text> </paragraph> <paragraph num="(c)"> <text>MedChi, the Maryland State Medical Society; or</text> </paragraph> <paragraph num="(d)"> <text>American Society of Radiologic Technologists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An LXMO shall obtain documentation of continuing education attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board.</text> </paragraph> <paragraph num="D."> <text>The required documentation of attendance at a continuing education course shall contain, at a minimum:</text> <paragraph num="(1)"> <text>Program title;</text> </paragraph> <paragraph num="(2)"> <text>Sponsor’s name;</text> </paragraph> <paragraph num="(3)"> <text>LXMO’s name;</text> </paragraph> <paragraph num="(4)"> <text>Inclusive date or dates and location of the continuing education event;</text> </paragraph> <paragraph num="(5)"> <text>Number of designated continuing education hours; and</text> </paragraph> <paragraph num="(6)"> <text>Documented verification of a successful completion.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physician Office Requirements."> <paragraph num="A."> <text>An LXMO shall wear an identification badge while on-site that states in readily visible type:</text> <paragraph num="(1)"> <text>The name of the LXMO; and</text> </paragraph> <paragraph num="(2)"> <text>The title “Limited X-Ray Machine Operator.”</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physician’s office employing an LXMO shall:</text> <paragraph num="(1)"> <text>Issue the LXMO an identification badge described in §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Verify all credentials of the LXMO;</text> </paragraph> <paragraph num="(3)"> <text>Keep readily retrievable, on-site documentation that the LXMO meets the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Permit the Board to inspect the documentation to ensure compliance with Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Verify all X-ray examinations performed by the LXMO are in accordance with Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Scope of Practice."> <paragraph num="A."> <text>An LXMO shall perform X-ray duties in a physician’s office under the immediately available supervision of a licensed physician or licensed radiologic technologist and in accordance with §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual registered as an LXMO may perform X-ray duties without a license only if the duties:</text> <paragraph num="(1)"> <text>Do not include:</text> <paragraph num="(a)"> <text>Computerized or non-computerized tomography;</text> </paragraph> <paragraph num="(b)"> <text>Fluoroscopy;</text> </paragraph> <paragraph num="(c)"> <text>Invasive radiology;</text> </paragraph> <paragraph num="(d)"> <text>Mammography;</text> </paragraph> <paragraph num="(e)"> <text>Nuclear medicine;</text> </paragraph> <paragraph num="(f)"> <text>Radiation therapy; or</text> </paragraph> <paragraph num="(g)"> <text>Xerography; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Are limited to X-ray procedures of the:</text> <paragraph num="(a)"> <text>Chest;</text> </paragraph> <paragraph num="(b)"> <text>Spine, including the:</text> <paragraph num="(i)"> <text>Cervical spine;</text> </paragraph> <paragraph num="(ii)"> <text>Lumbar spine;</text> </paragraph> <paragraph num="(iii)"> <text>Sacroiliac joints;</text> </paragraph> <paragraph num="(iv)"> <text>Sacrum and coccyx; and</text> </paragraph> <paragraph num="(v)"> <text>Thoracic spine;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Lower extremities, including:</text> <paragraph num="(i)"> <text>Toes;</text> </paragraph> <paragraph num="(ii)"> <text>The foot;</text> </paragraph> <paragraph num="(iii)"> <text>The ankle;</text> </paragraph> <paragraph num="(iv)"> <text>The calcaneus;</text> </paragraph> <paragraph num="(v)"> <text>The tibia and fibula;</text> </paragraph> <paragraph num="(vi)"> <text>The knee and patella; and</text> </paragraph> <paragraph num="(vii)"> <text>The femur; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Upper extremities, including:</text> <paragraph num="(i)"> <text>Fingers;</text> </paragraph> <paragraph num="(ii)"> <text>The hand;</text> </paragraph> <paragraph num="(iii)"> <text>The wrist;</text> </paragraph> <paragraph num="(iv)"> <text>The forearm;</text> </paragraph> <paragraph num="(v)"> <text>The elbow;</text> </paragraph> <paragraph num="(vi)"> <text>The humerus;</text> </paragraph> <paragraph num="(vii)"> <text>The shoulder;</text> </paragraph> <paragraph num="(viii)"> <text>The clavicle;</text> </paragraph> <paragraph num="(ix)"> <text>Acromioclavicular joints; and</text> </paragraph> <paragraph num="(x)"> <text>The scapula.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prohibited Conduct and Penalties."> <paragraph num="A."> <text>An LXMO acting beyond the scope of this chapter may be:</text> <paragraph num="(1)"> <text>Considered to be engaged in the unlicensed practice of radiography; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-601, 14-602 and 14-5B-17, Annotated Code of Maryland, and COMAR 10.32.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervising licensed physician or licensed radiologic technologist, through either act or omission, facilitation, or otherwise enabling or forcing an LXMO to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §§14-404(a) or 14-5B-14, Annotated Code of Maryland, including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine.</text> </paragraph> <paragraph num="C."> <text>A supervising licensed physician or licensed radiologic technologist may not:</text> <paragraph num="(1)"> <text>Require an LXMO to perform an X-ray procedure; and</text> </paragraph> <paragraph num="(2)"> <text>Permit an LXMO to delegate to another individual.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A physician’s office that employs an individual authorized to perform X-ray duties without a license is responsible for ensuring that all requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter are met for each X-ray examination performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Enforcement."> <paragraph num="A."> <text>The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a civil penalty of up to $5,000 per incident on a physician’s office for failure to comply with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="C."> <text>The Board may impose a civil penalty of up to $5,000 per incident on a physician's office who employs an unregistered individual to practice as an LXMO.</text> </paragraph> <paragraph num="D."> <text>The Board may impose a civil penalty of up to $1,000 per incident on an individual for failure to comply with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Fees."> <text>The following fees are applicable to LXMOs:</text> <paragraph num="A."> <text>Application for initial registration—$65;</text> </paragraph> <paragraph num="B."> <text>Renewal Fees:</text> <paragraph num="(1)"> <text>Renewal of registration fee—$125; and</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee—As determined by MHCC in accordance with COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement of registration fee—$135;</text> </paragraph> <paragraph num="D."> <text>Application to take the Limited Scope of Practice in Radiology examination—$10;</text> </paragraph> <paragraph num="E."> <text>LXMO registration fee per month until expiration of initial registration—$2; and</text> </paragraph> <paragraph num="F."> <text>Written verification fee—$25.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-205, 14-207, 14-306, and 14-308.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 25, 1994 (21:8 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 1, 2004 (31:4 Md. R. 316); August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective August 18, 2025 (52:16 Md. R. 846)</annotation> </annotations> </chapter> <chapter num="15" heading="Registration of Physicians to Perform Acupuncture"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a physician who has applied to the Board for registration to perform acupuncture in this State.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Medical acupuncture course of study” means a sequence of study in acupuncture approved by the Board, which sequence may consist of combinations of course work from unrelated institutions completed within 5 years of the date of application, that includes at least 200 hours of instruction in general and basic aspects, specific uses and techniques of acupuncture, and indications and contraindications of acupuncture administration.</text> </paragraph> <paragraph num="(4)"> <text>“Medical acupuncture program” means a program of study in acupuncture which has been approved for Category I continuing medical education credit by an institution accredited or recognized by the Accreditation Council on Continuing Medical Education to conduct Category I continuing medical education courses.</text> </paragraph> <paragraph num="(5)"> <text>“Physician” means an individual licensed to practice medicine in Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“To perform acupuncture” means to stimulate a certain point or points on or near the surface of the human body by the insertion of needles to prevent or modify the perception of pain or to normalize physiological functions, including pain control, for the treatment of ailments or conditions of the body and for maintenance of good health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application."> <text>To qualify for registration, a physician shall:</text> <paragraph num="A."> <text>Complete an application on a form supplied by the Board, enclosing:</text> <paragraph num="(1)"> <text>Required supplementary materials, which are in English, and</text> </paragraph> <paragraph num="(2)"> <text>English translations of certified, required documentation with costs borne by the applicant;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pay a registration fee of $150;</text> </paragraph> <paragraph num="C."> <text>Submit a current, signed passport-sized photograph;</text> </paragraph> <paragraph num="D."> <text>Be a licensed physician; and</text> </paragraph> <paragraph num="E."> <text>Submit evidence of having successfully completed 200 hours of training in a medical acupuncture program or course of study, including any required examinations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Unprofessional Conduct."> <text>Unprofessional conduct in the practice of medicine includes the failure of a physician to:</text> <paragraph num="A."> <text>Comply with the statute and regulations governing physicians who perform acupuncture, and includes representing oneself as a registered acupuncturist without having met all the previous requirements; and</text> </paragraph> <paragraph num="B."> <text>Be registered by the Board, or to have met all the requirements of Health Occupations Article, §§1A-101 — 1A-502 and §14-302(4) — (5), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Advertising."> <paragraph num="A."> <text>A physician who has been registered by the Board to perform acupuncture may advertise services subject to the provisions of this regulation.</text> </paragraph> <paragraph num="B."> <text>An advertisement may not express statements:</text> <paragraph num="(1)"> <text>Containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>That are likely to mislead or deceive because in context the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>That intend to or are likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relating to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully disclosing all relevant variables so that the statement would not be misunderstood or be deceptive to a layman;</text> </paragraph> <paragraph num="(5)"> <text>Conveying the impression that the physician who has been registered by the Board to perform acupuncture could improperly influence a public body, official, corporation, or an individual on behalf of a patient; or</text> </paragraph> <paragraph num="(6)"> <text>Containing representations that a physician who has been registered by the Board to perform acupuncture is:</text> <paragraph num="(a)"> <text>Willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States, or</text> </paragraph> <paragraph num="(b)"> <text>A licensed acupuncturist under Health Occupations Article, §1A-101 et seq., Annotated Code of Maryland, unless licensed by the State Acupuncture Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A physician who has been registered by the Board to perform acupuncture is accountable under this regulation if the physician uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §14-504, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 11, 1995 (22:18 Md. R. 1400)</annotation> </annotations> </chapter> <chapter num="16" heading="Petition for Declaratory Ruling"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Physicians.</text> </paragraph> <paragraph num="(2)"> <text>“Designee” means a person or committee to whom the Board has delegated responsibility for consideration of a petition.</text> </paragraph> <paragraph num="(3)"> <text>“Person” means:</text> <paragraph num="(a)"> <text>An individual;</text> </paragraph> <paragraph num="(b)"> <text>An agency;</text> </paragraph> <paragraph num="(c)"> <text>An association;</text> </paragraph> <paragraph num="(d)"> <text>A corporation; or</text> </paragraph> <paragraph num="(e)"> <text>Any other entity.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Petition."> <paragraph num="A."> <text>An interested person may file with the Board a petition for a declaratory ruling with respect to the manner in which the Board would apply:</text> <paragraph num="(1)"> <text>A statute;</text> </paragraph> <paragraph num="(2)"> <text>A regulation; or</text> </paragraph> <paragraph num="(3)"> <text>An order which the Board enforces to a particular case based on the facts presented in the petition.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may delegate responsibility for consideration of the petition. The delegation may be limited to the:</text> <paragraph num="(1)"> <text>Study of a request; and</text> </paragraph> <paragraph num="(2)"> <text>Preparation of a proposed ruling for the Board's consideration.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Petition for Declaratory Ruling.</text> <paragraph num="(1)"> <text>The petition for a declaratory ruling shall be filed in writing on a form provided by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The petition shall contain a statement describing in detail:</text> <paragraph num="(a)"> <text>The interest of the petitioner in making the request;</text> </paragraph> <paragraph num="(b)"> <text>The issue involved;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the facts; and</text> </paragraph> <paragraph num="(d)"> <text>A listing of documents or statements, or both, to be considered.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Unless this requirement is waived in writing by the Board, the petition shall contain a sworn statement by the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Granting of Petition.</text> <paragraph num="(1)"> <text>Not later than 60 days from receipt of the petition, the Board shall inform the petitioner whether the petition will be granted.</text> </paragraph> <paragraph num="(2)"> <text>If the petition is denied, the Board shall inform the petitioner in writing of the reasons for the denial.</text> </paragraph> <paragraph num="(3)"> <text>If the petition is granted, the Board or the Board's designee shall inform the petitioner when to expect the declaratory ruling.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Consideration and Disposition."> <paragraph num="A."> <text>Consideration.</text> <paragraph num="(1)"> <text>A petition will be granted whenever the Board or the Board's designee considers issuing a declaratory ruling advisable under the circumstances.</text> </paragraph> <paragraph num="(2)"> <text>In rendering its ruling, the Board or the Board's designee:</text> <paragraph num="(a)"> <text>Shall consider all materials submitted with the petition;</text> </paragraph> <paragraph num="(b)"> <text>May consider any document, data, or other relevant material;</text> </paragraph> <paragraph num="(c)"> <text>May consult individuals;</text> </paragraph> <paragraph num="(d)"> <text>May consider comments from the staff; and</text> </paragraph> <paragraph num="(e)"> <text>May require argument of the question or permit the introduction of evidence by the petitioner or, in the Board's sole discretion, by other persons.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Consideration of the proposed rulings prepared by the Board's designee shall be conducted according to procedures adopted by the Board in each case.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposition.</text> <paragraph num="(1)"> <text>A declaratory ruling issued shall be in writing, stating the:</text> <paragraph num="(a)"> <text>Issue;</text> </paragraph> <paragraph num="(b)"> <text>Conclusion;</text> </paragraph> <paragraph num="(c)"> <text>Facts on which the conclusion was based; and</text> </paragraph> <paragraph num="(d)"> <text>Sources relied upon.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A declaratory ruling issued by the Board shall plainly state that it is a declaratory ruling pursuant to this chapter.</text> </paragraph> <paragraph num="(3)"> <text>A written answer from the Board or any employee or committee of the Board to an inquiry is not a declaratory ruling unless made in conformity with this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Publication and Inspection.</text> <paragraph num="(1)"> <text>The Board shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to the statute or regulation involved.</text> </paragraph> <paragraph num="(2)"> <text>The Board may publish declaratory rulings of general interest subject to the mandates of State Government Article, Title 10, Subtitle 6, Part III, Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to that statute.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Denial. A petition may be denied if the:</text> <paragraph num="(1)"> <text>Request contains incomplete information on which to base an informed declaratory ruling;</text> </paragraph> <paragraph num="(2)"> <text>Board or the Board's designee concludes that a declaratory ruling cannot reasonably be given on the matter;</text> </paragraph> <paragraph num="(3)"> <text>Matter is adequately covered by a:</text> <paragraph num="(a)"> <text>Regulation,</text> </paragraph> <paragraph num="(b)"> <text>Declaratory ruling,</text> </paragraph> <paragraph num="(c)"> <text>Decision, or</text> </paragraph> <paragraph num="(d)"> <text>Legal opinion;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Matter is the subject of a pending disciplinary proceeding; or</text> </paragraph> <paragraph num="(5)"> <text>The Board or the Board's designee concludes that a ruling would not be in the public interest.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Effect, Revision, and Appeal."> <paragraph num="A."> <text>Effect. A declaratory ruling shall be binding on the Board and the petitioner on the statement of facts covered in the declaratory ruling.</text> </paragraph> <paragraph num="B."> <text>Application for Revision.</text> <paragraph num="(1)"> <text>The petitioner shall file an application for revision within 10 days after the issuance of the declaratory ruling.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall determine whether to reopen the declaratory ruling.</text> </paragraph> <paragraph num="(3)"> <text>The Board may summarily deny an application for revision.</text> </paragraph> <paragraph num="(4)"> <text>An application for revision does not stay the effect of the declaratory ruling. If the Board determines to grant the application and reopen the declaratory ruling, the declaratory ruling is stayed until the Board:</text> <paragraph num="(a)"> <text>Issues a revised declaratory ruling;</text> </paragraph> <paragraph num="(b)"> <text>Withdraws the declaratory ruling; or</text> </paragraph> <paragraph num="(c)"> <text>Withdraws its determination to reopen.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A timely filed application for revision extends the time for judicial appeal of the declaratory ruling until the Board:</text> <paragraph num="(a)"> <text>Denies the application;</text> </paragraph> <paragraph num="(b)"> <text>Issues a revised declaratory ruling;</text> </paragraph> <paragraph num="(c)"> <text>Withdraws the declaratory ruling; or</text> </paragraph> <paragraph num="(d)"> <text>Withdraws its determination to reopen.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the Board determines to reopen the declaratory ruling, the Board shall give the applicant notice of the determination and of any subsequent changes to the declaratory ruling. The determination to reopen a declaratory ruling does not confer any procedural rights on the applicant.</text> </paragraph> <paragraph num="(7)"> <text>The Board shall deny applications for revision which contain additional or revised facts. The Board may treat the application as a request for a new declaratory ruling.</text> </paragraph> <paragraph num="(8)"> <text>After determining to reopen a declaratory ruling, the Board may take any action which it is authorized to take with respect to original applications for declaratory rulings.</text> </paragraph> <paragraph num="(9)"> <text>The Board's determination as to whether to reopen the declaratory ruling shall be made within 60 days of the application for revision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Revision on Board's Motion.</text> <paragraph num="(1)"> <text>The Board may reopen a declaratory ruling on its own motion at any time 2 years or more after a declaratory ruling's issuance.</text> </paragraph> <paragraph num="(2)"> <text>The declaratory ruling may be reopened if the Board determines that there have been subsequent changes in law, technology, economic or business conditions, or environment that render the declaratory ruling inaccurate or obsolete.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall give notice to the petitioner of the Board's decision to reopen a declaratory ruling.</text> </paragraph> <paragraph num="(4)"> <text>Before a declaratory ruling is finally modified under this section, the Board shall give the petitioner the opportunity to submit written and oral argument to the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">State Government Article, §§10-301 — 10-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 5, 1999 (26:7 Md. R. 543)</annotation> </annotations> </chapter> <chapter num="17" heading="Sexual Misconduct"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter prohibits sexual misconduct by health care practitioners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Health care practitioner” means an individual licensed under Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Key Third Party.</text> <paragraph num="(a)"> <text>“Key third party” means an individual who participates in the health and welfare of the patient concurrent with the physician-patient relationship.</text> </paragraph> <paragraph num="(b)"> <text>“Key third party” includes, but is not limited to the following individuals:</text> <paragraph num="(i)"> <text>Spouse;</text> </paragraph> <paragraph num="(ii)"> <text>Partner;</text> </paragraph> <paragraph num="(iii)"> <text>Family member;</text> </paragraph> <paragraph num="(iv)"> <text>Guardian;</text> </paragraph> <paragraph num="(v)"> <text>Surrogate; or</text> </paragraph> <paragraph num="(vi)"> <text>Proxy designated by durable power of attorney.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Sexual Contact.</text> <paragraph num="(a)"> <text>“Sexual contact” means the knowing touching directly or through clothing, where the circumstances surrounding the touching would be construed by a reasonable person to be motivated by the health care practitioner’s own prurient interest or for sexual arousal or gratification.</text> </paragraph> <paragraph num="(b)"> <text>“Sexual contact” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Sexual intercourse, genital to genital contact;</text> </paragraph> <paragraph num="(ii)"> <text>Oral to genital contact;</text> </paragraph> <paragraph num="(iii)"> <text>Oral to anal contact or genital to anal contact;</text> </paragraph> <paragraph num="(iv)"> <text>Kissing in a romantic or sexual manner; or</text> </paragraph> <paragraph num="(v)"> <text>Nonclinical touching of breasts, genitals, or any other sexualized body part.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Sexual harassment” means an unwelcome sexual advance, request for sexual favor, or other verbal or physical conduct of a sexual nature.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Sexual Misconduct."> <paragraph num="A."> <text>Health care practitioners may not engage in sexual misconduct.</text> </paragraph> <paragraph num="B."> <text>Health Occupations Article, §§14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19), and 15-314(a)(3), Annotated Code of Maryland, includes, but is not limited to, sexual misconduct.</text> </paragraph> <paragraph num="C."> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Engaging in sexual harassment of a patient, key third party, employee, student, or coworker regardless of whether the sexual harassment occurs inside or outside of a professional setting;</text> </paragraph> <paragraph num="(2)"> <text>Failing to provide privacy for disrobing;</text> </paragraph> <paragraph num="(3)"> <text>Performing a pelvic or rectal examination without the use of gloves;</text> </paragraph> <paragraph num="(4)"> <text>Discussing the health care practitioner’s sexual problems, sexual likes or dislikes, or fantasies;</text> </paragraph> <paragraph num="(5)"> <text>Using the health care practitioner-patient relationship to initiate or solicit a dating, romantic, or sexual relationship;</text> </paragraph> <paragraph num="(6)"> <text>Engaging in a dating, romantic, or sexual relationship which violates §D of this regulation or the code of ethics of the American Medical Association, American Osteopathic Association, American Psychiatric Association, or other professional code of ethics;</text> </paragraph> <paragraph num="(7)"> <text>Participating in any form of sexual contact with a patient or key third party;</text> </paragraph> <paragraph num="(8)"> <text>Having nonconsensual sexual contact with a coworker or employee;</text> </paragraph> <paragraph num="(9)"> <text>Causing a patient or key third party to touch the health care practitioner’s breasts, genitals, or any sexualized body part;</text> </paragraph> <paragraph num="(10)"> <text>Encouraging a patient or key third party to masturbate in the presence of the health care practitioner or masturbation by the health care practitioner while a patient or key third party is present;</text> </paragraph> <paragraph num="(11)"> <text>Offering to provide practice-related services in exchange for sexual favors; and</text> </paragraph> <paragraph num="(12)"> <text>Exposing the health care practitioner’s breasts, genitals, or any sexualized body part.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Sexual or Romantic Relationships. A health care practitioner may not engage in sexual behavior with:</text> <paragraph num="(1)"> <text>A current patient;</text> </paragraph> <paragraph num="(2)"> <text>A key third party if the key third party’s decisions directly affect the health and welfare of the patient or if the relationship could otherwise compromise the patient’s care based on the following considerations, which include, but are not limited to:</text> <paragraph num="(a)"> <text>The nature of the patient’s medical problem and the likely effect on patient care;</text> </paragraph> <paragraph num="(b)"> <text>The length of the professional relationship;</text> </paragraph> <paragraph num="(c)"> <text>The degree of emotional dependence on the health care practitioner;</text> </paragraph> <paragraph num="(d)"> <text>The importance of the clinical encounter to the key third party and the patient; and</text> </paragraph> <paragraph num="(e)"> <text>Whether the health care practitioner-patient relationship can be terminated in keeping with ethics guidance and what implications doing so would have for the patient; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A former patient upon consideration of the following factors:</text> <paragraph num="(a)"> <text>Duration of the health care practitioner-patient relationship;</text> </paragraph> <paragraph num="(b)"> <text>Nature of the health care services provided;</text> </paragraph> <paragraph num="(c)"> <text>Lapse of time since the health care practitioner-patient relationship ended;</text> </paragraph> <paragraph num="(d)"> <text>Extent to which the former patient confided personal or private information to the health care practitioner;</text> </paragraph> <paragraph num="(e)"> <text>Degree of emotional dependence that the former patient has or had on the health care practitioner;</text> </paragraph> <paragraph num="(f)"> <text>Extent to which the health care practitioner used or exploited the trust, knowledge, emotions, or influence derived from the previous health care practitioner-patient relationship; and</text> </paragraph> <paragraph num="(g)"> <text>Whether the health care practitioner-patient relationship was terminated in order to enter into a romantic or sexual relationship.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §1-212, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 6, 2000 (27:4 Md. R. 454)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 488)</annotation> </annotations> </chapter> <chapter num="18" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>A custodian of the Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation or over a facility in which the individual is practicing or has practiced and the information disclosed is limited to that information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual or regulates a facility in which the individual has practiced, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-405 and 14-411; State Government Article, §10-617(h)(3); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 10, 2002 (29:11 Md. R. 889)</annotation> </annotations> </chapter> <chapter num="19" heading="Disclosure of Records to State Health Agencies"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not alter the authority of the Secretary under of the Health Occupations Article, §1-203(a), Annotated Code of Maryland or Health-General Article, §2-106(c), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Physicians.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Record” means the proceedings, records, or files of the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disclosure of Information to the Department and Agencies Within the Department."> <paragraph num="A."> <text>The Board shall disclose information contained in a record to the Secretary upon receipt of a written request from the Secretary stating that the requested information is appropriate and needed for:</text> <paragraph num="(1)"> <text>An investigation of quality or utilization of care in an entity regulated by the Office of Health Care Quality;</text> </paragraph> <paragraph num="(2)"> <text>An investigation of quality or utilization of care in an entity regulated by the Health Services Cost Review Commission; or</text> </paragraph> <paragraph num="(3)"> <text>An investigation regarding the introduction or spread of an infectious or contagious disease or other disease that endangers the public health in the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall disclose information contained in a record to the Office of Health Care Quality upon receipt of a written request from the Director of the Office of Health Care Quality stating that the requested information is appropriate and needed for an investigation of quality or utilization of care in an entity regulated by the Office of Health Care Quality.</text> </paragraph> <paragraph num="C."> <text>The Board shall disclose information contained in a record to the Health Services Cost Review Commission upon receipt of a written request from the Executive Director of the Health Services Cost Review Commission stating that the requested information is appropriate and needed for an investigation of quality or utilization of care in an entity regulated by the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="D."> <text>The Board shall disclose information contained in a record to the Maryland Health Care Commission upon receipt of a written request from the Executive Director of the Maryland Health Care Commission stating that the requested information is appropriate and needed in an investigation of quality or utilization of care in an entity regulated by the Maryland Health Care Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements Regarding the Transfer of a Record."> <paragraph num="A."> <text>The Board shall disclose the information required under this chapter as soon as reasonably possible, but no later than 30 days after a request made under this chapter.</text> </paragraph> <paragraph num="B."> <text>The information disclosed by the Board under this chapter shall be sent on paper by first-class mail or by another delivery method agreed to by the Board and the Secretary or agency requesting the information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Confidentiality."> <text>Information disclosed by the Board under this chapter shall remain confidential and may not be redisclosed by the Secretary, the Office of Health Care Quality, the Health Services Cost Review Commission, or the Maryland Health Care Commission unless otherwise permitted by law.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-102; Health Occupations Article, §14-411; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 3, 2014 (41:4 Md. R. 301)</annotation> </annotations> </chapter> <chapter num="20" heading="Licensure of Perfusionists"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of perfusion.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C or D of this regulation, on or after October 1, 2013, an individual shall be licensed by the Board before the individual may practice perfusion.</text> </paragraph> <paragraph num="C."> <text>This chapter does not prohibit any student who is currently enrolled in an accredited educational program to qualify for a license as a perfusionist from performing any of the procedures described in this chapter as part of that program’s clinical curriculum on perfusion.</text> </paragraph> <paragraph num="D."> <text>This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational program” means a program accredited by The Commission on Accreditation of Allied Health Education Programs (CAAHEP), or its successor accrediting agency.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Certified clinical perfusionist” means an individual holding a certificate issued by the national certifying board.</text> </paragraph> <paragraph num="(4)"> <text>“Certification” means recognition of an individual who has satisfied certain standards required by the national certifying board.</text> </paragraph> <paragraph num="(5)"> <text>“Committee” means the Perfusion Advisory Committee established under Health Occupations Article, §14-5E-05, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Conversion” means changing a license from licensed perfusionist-basic to licensed perfusionist-advanced.</text> </paragraph> <paragraph num="(7)"> <text>“Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which:</text> <paragraph num="(a)"> <text>Is composed of 11 Board members; and</text> </paragraph> <paragraph num="(b)"> <text>Addresses:</text> <paragraph num="(i)"> <text>Complaints and disciplinary actions against licensed physicians and allied health professionals;</text> </paragraph> <paragraph num="(ii)"> <text>Initial licensure decisions; and</text> </paragraph> <paragraph num="(iii)"> <text>Postdisciplinary licensure reinstatements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Immediately available direction” means the responsibility of a licensed physician to provide necessary direction for a licensed perfusionist in person, by telephone, or by other electronic means.</text> </paragraph> <paragraph num="(9)"> <text>“Joint Commission” means the organization formerly known as the Joint Commission on the Accreditation of Health Care Organizations.</text> </paragraph> <paragraph num="(10)"> <text>“License” means a license issued by the Board to practice perfusion.</text> </paragraph> <paragraph num="(11)"> <text>“Licensed perfusionist” means a perfusionist who is licensed by the Board, in accordance with Health Occupations Article, Title 14, Subtitle 5E, Annotated Code of Maryland, to practice perfusion as a:</text> <paragraph num="(a)"> <text>Licensed perfusionist-advanced; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed perfusionist-basic.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Licensed perfusionist-advanced” means an individual who is licensed by the Board as a perfusionist based on current certification as a certified clinical perfusionist.</text> </paragraph> <paragraph num="(13)"> <text>“Licensed perfusionist-basic” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board as a perfusionist for a limited time based on graduation from an accredited perfusion educational program; and</text> </paragraph> <paragraph num="(b)"> <text>Has not yet passed the national certifying examinations given by the national certifying board.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Licensed physician” means a physician licensed by the Board.</text> </paragraph> <paragraph num="(15)"> <text>“National Certifying Board” means the American Board of Cardiovascular Perfusion or its successor.</text> </paragraph> <paragraph num="(16)"> <text>“National certifying examinations” means the two examinations given by the national certifying board.</text> </paragraph> <paragraph num="(17)"> <text>“On-site direction” means the responsibility of a licensed physician to provide necessary direction for a licensed perfusionist when the physician is:</text> <paragraph num="(a)"> <text>Physically present in the procedure room or in the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Able to respond if the perfusionist needs assistance during a procedure.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Practice Perfusion.</text> <paragraph num="(a)"> <text>“Practice perfusion” means to perform the functions necessary for the support, treatment, measurement, or supplementation of the cardiovascular, circulatory, or respiratory systems, or other organs to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under an order and the supervision of a licensed physician.</text> </paragraph> <paragraph num="(b)"> <text>“Practice perfusion” includes:</text> <paragraph num="(i)"> <text>Cardiopulmonary bypass for adult, pediatric, and neonatal patients;</text> </paragraph> <paragraph num="(ii)"> <text>Extracorporeal circulatory support for renal, neurological, hepatic, and vascular surgery;</text> </paragraph> <paragraph num="(iii)"> <text>Extracorporeal resuscitation;</text> </paragraph> <paragraph num="(iv)"> <text>Extracorporeal circulation for long-term support of failing respiratory or cardiac function;</text> </paragraph> <paragraph num="(v)"> <text>Extracorporeal membrane oxygenation;</text> </paragraph> <paragraph num="(vi)"> <text>Extracorporeal carbon dioxide removal;</text> </paragraph> <paragraph num="(vii)"> <text>Myocardial protection;</text> </paragraph> <paragraph num="(viii)"> <text>Perfusion-assisted direct coronary artery bypass;</text> </paragraph> <paragraph num="(ix)"> <text>Hemofiltration and hemodialysis;</text> </paragraph> <paragraph num="(x)"> <text>Anticoagulation and hemostasis monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(xi)"> <text>Thermal regulation;</text> </paragraph> <paragraph num="(xii)"> <text>Blood gas and blood chemistry monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(xiii)"> <text>Physiological monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(xiv)"> <text>Administration of blood components and pharmaceuticals;</text> </paragraph> <paragraph num="(xv)"> <text>Administration of anesthetic agents through a heart lung machine at the direction of an anesthesiologist;</text> </paragraph> <paragraph num="(xvi)"> <text>Ventricular assist device and mechanical circulatory support management;</text> </paragraph> <paragraph num="(xvii)"> <text>Intra-aortic balloon counterpulsation;</text> </paragraph> <paragraph num="(xviii)"> <text>Temporary pacemaker management;</text> </paragraph> <paragraph num="(xix)"> <text>Periodic flow augmentation therapy;</text> </paragraph> <paragraph num="(xx)"> <text>Autotransfusion;</text> </paragraph> <paragraph num="(xxi)"> <text>Platelet gel production, autologous hemocyte tissue matrix production;</text> </paragraph> <paragraph num="(xxii)"> <text>Nondifferentiated progenitor cell harvest bone marrow aspirate concentration;</text> </paragraph> <paragraph num="(xxiii)"> <text>Acute normovolemic hemodilution;</text> </paragraph> <paragraph num="(xxiv)"> <text>Isolated limb or organ delivery of chemotherapeutics, progenitor cells, gene therapy vectors, and other items;</text> </paragraph> <paragraph num="(xxv)"> <text>Organ procurement and preservation;</text> </paragraph> <paragraph num="(xxvi)"> <text>Thermogenic lavage;</text> </paragraph> <paragraph num="(xxvii)"> <text>Electrophysiological analysis;</text> </paragraph> <paragraph num="(xxviii)"> <text>Therapeutic hyperthermia;</text> </paragraph> <paragraph num="(xxix)"> <text>Intravascular membrane oxygenation; and</text> </paragraph> <paragraph num="(xxx)"> <text>Renal perfusion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Student” means an individual who, in accordance with Health Occupations Article, §14-5E-09(c), Annotated Code of Maryland, is:</text> <paragraph num="(a)"> <text>Enrolled in an accredited educational program to qualify for a license; and</text> </paragraph> <paragraph num="(b)"> <text>Performing perfusion services within the accredited program under the supervision of a licensed perfusionist and without compensation.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Supervision” means the responsibility of a licensed physician to exercise on-site direction or immediately available direction for a licensed perfusionist to ensure the safety and welfare of patients during the course of perfusion.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Perfusion Advisory Committee."> <paragraph num="A."> <text>The Board shall appoint members of the Committee as follows:</text> <paragraph num="(1)"> <text>Three individuals who are licensed perfusionists-advanced and who:</text> <paragraph num="(a)"> <text>Are certified by a National Certifying Board; and</text> </paragraph> <paragraph num="(b)"> <text>Have a minimum of 2 years of perfusion experience.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Three physicians, at least one of whom:</text> <paragraph num="(a)"> <text>Performs cardiac or cardio-thoracic surgery; or</text> </paragraph> <paragraph num="(b)"> <text>Is a cardiac or cardio-thoracic anesthesiologist; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One consumer member who:</text> <paragraph num="(a)"> <text>Shall be a member of the general public; and</text> </paragraph> <paragraph num="(b)"> <text>May not:</text> <paragraph num="(i)"> <text>Practice, or ever have practiced perfusion, or any other health care profession;</text> </paragraph> <paragraph num="(ii)"> <text>Be, or ever have been, in training to practice perfusion or any other health care profession;</text> </paragraph> <paragraph num="(iii)"> <text>Have a household member who is a health care professional or is in training to be a health care professional;</text> </paragraph> <paragraph num="(iv)"> <text>Participate, or ever have participated, in a commercial or professional field related to perfusion;</text> </paragraph> <paragraph num="(v)"> <text>Have a household member who participates in a commercial or professional field related to perfusion;</text> </paragraph> <paragraph num="(vi)"> <text>Have had, within 2 years before appointment, a financial interest in a person regulated by the Board; or</text> </paragraph> <paragraph num="(vii)"> <text>Have had, within 2 years of appointment, a financial interest in the provision of goods or services to perfusionists or to the field of perfusion.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Chair.</text> <paragraph num="(1)"> <text>The Committee shall elect a chair from among its members.</text> </paragraph> <paragraph num="(2)"> <text>The chair shall serve for 2 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed and qualifies.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second 3-year term, but the individual may not serve more than two consecutive 3-year terms.</text> </paragraph> <paragraph num="(5)"> <text>The terms of the initial members of the Perfusion Advisory Committee shall expire as follows:</text> <paragraph num="(a)"> <text>Two members in 2013;</text> </paragraph> <paragraph num="(b)"> <text>Two members in 2014; and</text> </paragraph> <paragraph num="(c)"> <text>Three members in 2015.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs, the Board shall appoint a new member to serve.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall only serve for the remainder of the term, unless reappointed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the members then serving on the Committee is a quorum.</text> </paragraph> <paragraph num="(2)"> <text>Business may not be conducted at a Committee meeting unless there is a quorum.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Committee shall develop and make recommendations to the Board in any matter related to regulating the practice of perfusion in the State.</text> </paragraph> <paragraph num="G."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Consider all recommendations of the Committee; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the Committee with an annual report on disciplinary matters involving licensees.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Code of Ethics."> <paragraph num="A."> <text>The ethical responsibilities of a licensed perfusionist include, but are not limited to, compliance with the principles set forth in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>A licensed perfusionist:</text> <paragraph num="(1)"> <text>Shall:</text> <paragraph num="(a)"> <text>Practice medically acceptable methods of treatment and may not endeavor to practice beyond the competence and the authority vested in the perfusionist by the physician;</text> </paragraph> <paragraph num="(b)"> <text>Report:</text> <paragraph num="(i)"> <text>Known illegal, unethical, or incompetent conduct; or</text> </paragraph> <paragraph num="(ii)"> <text>In good faith, suspected illegal, unethical, or incompetent conduct;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Respect the patient’s rights and dignity;</text> </paragraph> <paragraph num="(d)"> <text>Maintain patient confidentiality and protect privileged information;</text> </paragraph> <paragraph num="(e)"> <text>Place the patient’s best interest ahead of all else;</text> </paragraph> <paragraph num="(f)"> <text>Guard against conflicts of interest including avoiding those involving financial or personal gain;</text> </paragraph> <paragraph num="(g)"> <text>Uphold the dignity and honor of the profession and abide by its ethical principles; and</text> </paragraph> <paragraph num="(h)"> <text>Be familiar with existing state and federal laws governing the practice of perfusion and comply with those laws; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May not:</text> <paragraph num="(a)"> <text>Delegate any perfusion duty to an individual not having the appropriate training and skill to undertake such responsibility;</text> </paragraph> <paragraph num="(b)"> <text>Falsify documentation on patient records; and</text> </paragraph> <paragraph num="(c)"> <text>Falsify reports submitted to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>All services shall be provided with respect for the dignity of the patient, unrestricted by considerations of:</text> <paragraph num="(1)"> <text>Social or economic status;</text> </paragraph> <paragraph num="(2)"> <text>Personal attributes; or</text> </paragraph> <paragraph num="(3)"> <text>The nature of health problems.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A breach of ethical principles may be considered immoral or unprofessional conduct in the practice of perfusion.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards of Care."> <paragraph num="A."> <text>In evaluating the standards of care for the practice of a licensed perfusionist, the Board may consider, but is not limited to, the guidelines published by the American Society of Extracorporeal Technology (AmSECT).</text> </paragraph> <paragraph num="B."> <text>If a particular practice issue has not yet been addressed in the AmSECT guidelines, the Board may consult with a licensed perfusionist-advanced.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Qualifications for Licensure as a Perfusionist."> <paragraph num="A."> <text>The Board shall license an individual if the individual meets the requirements of §§B and C of this regulation.</text> </paragraph> <paragraph num="B."> <text>An individual applying for a license shall:</text> <paragraph num="(1)"> <text>Complete an application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the required application fee set by the Board in Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrate spoken and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of graduation from a recognized English-speaking professional school; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of receiving a grade of at least:</text> <paragraph num="(i)"> <text>26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>79 on the total score of the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>If applicable, provide documentation of licensure, certification, or registration from all states and jurisdictions where the applicant has ever held a license, certificate, or registration in any health profession;</text> </paragraph> <paragraph num="(7)"> <text>Have no history of public disciplinary action taken, or pending, against any license currently or previously held or expired; and</text> </paragraph> <paragraph num="(8)"> <text>Complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for a license as:</text> <paragraph num="(1)"> <text>A perfusionist-basic shall submit satisfactory evidence of graduation from a perfusion educational program that is accredited by the Commission on Accreditation of the Allied Health Education Program, or the Commission’s predecessor or successor;</text> </paragraph> <paragraph num="(2)"> <text>A perfusionist-advanced shall submit satisfactory evidence of current national certification from the National Certifying Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Scope of Practice."> <paragraph num="A."> <text>A licensed perfusionist may practice only under the supervision of a licensed physician.</text> </paragraph> <paragraph num="B."> <text>The scope of practice of a licensed perfusionist is performance of the functions necessary for the support, treatment, measurement, or supplementation of the cardiovascular, circulatory, or respiratory systems, or other organs to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems.</text> </paragraph> <paragraph num="C."> <text>The scope of practice of a licensed perfusionist includes the following special procedures, performed on the order of and under the supervision of a licensed physician:</text> <paragraph num="(1)"> <text>Cardiopulmonary bypass for adult, pediatric, and neonatal patients;</text> </paragraph> <paragraph num="(2)"> <text>Extracorporeal circulatory support for renal, neurological, hepatic, and vascular surgery;</text> </paragraph> <paragraph num="(3)"> <text>Extracorporeal resuscitation;</text> </paragraph> <paragraph num="(4)"> <text>Extracorporeal circulation for long-term support of failing respiratory or cardiac function;</text> </paragraph> <paragraph num="(5)"> <text>Extracorporeal membrane oxygenation;</text> </paragraph> <paragraph num="(6)"> <text>Extracorporeal carbon dioxide removal;</text> </paragraph> <paragraph num="(7)"> <text>Myocardial protection;</text> </paragraph> <paragraph num="(8)"> <text>Perfusion-assisted direct coronary artery bypass;</text> </paragraph> <paragraph num="(9)"> <text>Hemofiltration and hemodialysis;</text> </paragraph> <paragraph num="(10)"> <text>Anticoagulation and hemostasis monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(11)"> <text>Thermal regulation;</text> </paragraph> <paragraph num="(12)"> <text>Blood gas and blood chemistry monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(13)"> <text>Physiological monitoring, analysis, and intervention;</text> </paragraph> <paragraph num="(14)"> <text>Administration of blood components and pharmaceuticals;</text> </paragraph> <paragraph num="(15)"> <text>Administration of anesthetic agents through a heart lung machine at the direction of an anesthesiologist;</text> </paragraph> <paragraph num="(16)"> <text>Ventricular assist device and mechanical circulatory support management;</text> </paragraph> <paragraph num="(17)"> <text>Intra-aortic balloon counterpulsation;</text> </paragraph> <paragraph num="(18)"> <text>Temporary pacemaker management;</text> </paragraph> <paragraph num="(19)"> <text>Periodic flow augmentation therapy;</text> </paragraph> <paragraph num="(20)"> <text>Autotransfusion;</text> </paragraph> <paragraph num="(21)"> <text>Platelet gel production, autologous hemocyte tissue matrix production;</text> </paragraph> <paragraph num="(22)"> <text>Nondifferentiated progenitor cell harvest bone marrow aspirate concentration;</text> </paragraph> <paragraph num="(23)"> <text>Acute normovolemic hemodilution;</text> </paragraph> <paragraph num="(24)"> <text>Isolated limb or organ delivery of chemotherapeutics, progenitor cells, gene therapy vectors, and other items;</text> </paragraph> <paragraph num="(25)"> <text>Organ procurement and preservation;</text> </paragraph> <paragraph num="(26)"> <text>Thermogenic lavage;</text> </paragraph> <paragraph num="(27)"> <text>Electrophysiological analysis;</text> </paragraph> <paragraph num="(28)"> <text>Therapeutic hyperthermia;</text> </paragraph> <paragraph num="(29)"> <text>Intravascular membrane oxygenation; and</text> </paragraph> <paragraph num="(30)"> <text>Renal perfusion.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Identification; Notice."> <paragraph num="A."> <text>A licensed perfusionist shall wear an identification tag or a badge which identifies that individual as a licensed perfusionist.</text> </paragraph> <paragraph num="B."> <text>License.</text> <paragraph num="(1)"> <text>A licensed perfusionist shall:</text> <paragraph num="(a)"> <text>Keep a copy of the licensee’s license in their employment file; and</text> </paragraph> <paragraph num="(b)"> <text>Make the license available for inspection upon request.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the perfusionist has multiple places of employment, copies of the license may be kept in accordance with §B(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Change of Name or Address.</text> <paragraph num="(1)"> <text>A licensed perfusionist shall notify the Board in writing of any changes in name or mailing address within 60 days.</text> </paragraph> <paragraph num="(2)"> <text>The Board may impose a fine of $100 for failure to notify the Board of a change in name or mailing address.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Terms of Perfusionist-Basic License."> <paragraph num="A."> <text>Term and Expiration.</text> <paragraph num="(1)"> <text>A perfusionist-basic license shall expire 2 years after it is issued.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §§D and E of this regulation, a perfusionist-basic license may not be renewed or extended beyond the 2-year expiration date.</text> </paragraph> <paragraph num="(3)"> <text>An individual who previously held a perfusionist-basic license may not be granted a new perfusionist-basic license.</text> </paragraph> <paragraph num="(4)"> <text>Upon expiration of the perfusionist-basic license, an individual who does not meet the requirements for a perfusionist-advanced license is ineligible for licensure and may not practice perfusion in this State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Conversion.</text> <paragraph num="(1)"> <text>The holder of a perfusionist-basic license shall convert the license to a perfusionist-advanced license at any time before the expiration after meeting the requirements outlined in Regulation .06B(2) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The individual shall ensure that the national certifying board submits evidence, satisfactory to the Board, that the individual meets the requirements of Regulation .06B(2) of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>If the Board receives the notification specified in §B(2) of this regulation, the Board shall issue a perfusionist-advanced license to the individual at no additional charge.</text> </paragraph> <paragraph num="(4)"> <text>If the holder of the perfusionist-basic license fails to convert the license to a perfusionist-advanced license before the expiration date, the individual shall file a new application for a perfusionist-advanced license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Conversion-or-Expiration Notice. At least 1 month before the expiration of the perfusionist-basic license, the Board shall send notice to the licensed perfusionist-basic that states:</text> <paragraph num="(1)"> <text>The date on which the current perfusionist-basic license expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which notification of meeting requirements outlined in Regulation .06B(2) shall be received in order to convert to a perfusionist-advanced license before the perfusionist-basic license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Notice that upon expiration of the perfusionist-basic license, if the holder does not qualify for a perfusionist-advanced license, the holder is no longer permitted to practice perfusion in this State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may permit a perfusionist with a basic license to continue to practice on that license if extenuating circumstances prevented the applicant for an advanced license from taking the national certifying examination given by the American Board of Cardiovascular Perfusion. The applicant shall specify the:</text> <paragraph num="(1)"> <text>Extenuating circumstances; and</text> </paragraph> <paragraph num="(2)"> <text>Basis for granting the request.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Petition for Extension.</text> <paragraph num="(1)"> <text>At the discretion of the Board, a petition for extension of a perfusionist-basic license expiration date may be considered if:</text> <paragraph num="(a)"> <text>The licensee:</text> <paragraph num="(i)"> <text>Incurs a hardship that prevents the licensee from active use of the perfusionist-basic license for a period of at least 45 consecutive calendar days;</text> </paragraph> <paragraph num="(ii)"> <text>Provides a written request, with supporting documentation if applicable, stating the extenuating circumstances that will prohibit or has prohibited the licensee from active use of the perfusionist-basic license for at least 45 consecutive calendar days; and</text> </paragraph> <paragraph num="(iii)"> <text>Provides an anticipated date for resuming activity on the perfusionist-basic license; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The national certifying examination has been administered during no more than three testing windows from the time the application for the perfusionist basic license was approved.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A perfusionist with a basic license may not practice during the paused time frame. Practicing or attempting to practice without an active license is in violation of Regulation .15 of this chapter and is punishable under that regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Board may grant a one-time extension of the perfusionist-basic license expiration date but the extension may not exceed the time period that the perfusionist with the basic license did not have active use of the license.</text> </paragraph> <paragraph num="(4)"> <text>The Board may grant an extension if the Board determines that failure to fulfill the license requirements is clearly the result of:</text> <paragraph num="(a)"> <text>Functional impairment;</text> </paragraph> <paragraph num="(b)"> <text>Prolonged and serious illness;</text> </paragraph> <paragraph num="(c)"> <text>Mandatory military service or deployment;</text> </paragraph> <paragraph num="(d)"> <text>A prolonged absence from the United States;</text> </paragraph> <paragraph num="(e)"> <text>An officially declared disaster; or</text> </paragraph> <paragraph num="(f)"> <text>Other exceptional circumstances beyond the control of the applicant.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Failing the national certification examination is not grounds for obtaining an extension.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewal and Reinstatement of Licensure as a Perfusionist-Advanced."> <paragraph num="A."> <text>Renewal Notice. At least 1 month before the license expires, the Board shall send a renewal notice to the licensed perfusionist-advanced that states:</text> <paragraph num="(1)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the license expires; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee set by the Board in Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal.</text> <paragraph num="(1)"> <text>The term of a license issued by the Board may not exceed 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(3)"> <text>An individual licensed as a perfusionist-basic may not renew the license.</text> </paragraph> <paragraph num="(4)"> <text>An individual who has been licensed by the Board as a perfusionist-advanced may renew the license every 2 years on or before the date specified by the Board by:</text> <paragraph num="(a)"> <text>Submitting a renewal application online or on a form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee set by the Board in Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Attesting to current certification by the National Certifying Board; and</text> </paragraph> <paragraph num="(d)"> <text>Being of good moral character.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement. The Board shall reinstate the license of a perfusionist-advanced who has failed to renew the license for any reason if the perfusionist-advanced:</text> <paragraph num="(1)"> <text>Completes a reinstatement application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Meets any additional requirements set by the Board for reinstatement of a license;</text> </paragraph> <paragraph num="(3)"> <text>Pays the required reinstatement fee and any other applicable fees set by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Is of good moral character; and</text> </paragraph> <paragraph num="(5)"> <text>Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement of a Revoked License.</text> <paragraph num="(1)"> <text>On the application of an individual whose license has been revoked, the Board, on the affirmative vote of a majority of the quorum, may in its discretion reinstate a revoked license.</text> </paragraph> <paragraph num="(2)"> <text>When a time period is not stated in an order for revocation:</text> <paragraph num="(a)"> <text>The Board may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order; and</text> </paragraph> <paragraph num="(b)"> <text>A revocation of a license may not be for less than 1 year.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may not entertain an application for post-disciplinary reinstatement after an order of revocation unless:</text> <paragraph num="(a)"> <text>Any time period stated in the order has expired;</text> </paragraph> <paragraph num="(b)"> <text>Any condition set out in the order has been fulfilled;</text> </paragraph> <paragraph num="(c)"> <text>The applicant has filed a formal application and paid the fee set by the Board in Regulation .13 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>The applicant meets all of the requirements for reinstatement set out in §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B.</text> </paragraph> <paragraph num="(5)"> <text>The Board may not entertain applications for reinstatement if a revocation is permanent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Continuing Education."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>The continuing education requirements apply to all renewal applications.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not renew or reinstate the license of a perfusionist-advanced unless the perfusionist-advanced has met the requirements for continuing education described in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements. A licensed perfusionist-advanced shall meet continuing education requirements sufficient to maintain current national certification from the National Certifying Board.</text> </paragraph> <paragraph num="C."> <text>Documentation of Continuing Education Credits. A current certificate from the national certifying board will serve as documentation of continuing education credits earned.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Clinical Activity."> <paragraph num="A."> <text>Application.</text> <paragraph num="(1)"> <text>The clinical activity requirements apply to all renewal applications.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not renew or reinstate the license of a perfusionist-advanced unless the perfusionist-advanced has met the requirements for clinical activity described in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements. A licensed perfusionist-advanced shall meet clinical activity requirements sufficient to maintain current national certification from the national certifying board.</text> </paragraph> <paragraph num="C."> <text>Documentation of Clinical Activity. A current certificate from the national certifying board will serve as documentation of clinical activities performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Fees."> <text>The following non-refundable fees are applicable to perfusionists:</text> <paragraph num="A."> <text>Perfusionist initial license application fee:</text> <paragraph num="(1)"> <text>Before October 1, 2015 — $300; and</text> </paragraph> <paragraph num="(2)"> <text>After October 1, 2015 — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013);</text> </paragraph> </paragraph> <paragraph num="B."> <text>Perfusionist license renewal fees, after October 1, 2015:</text> <paragraph num="(1)"> <text>License renewal fee — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013);</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission (MHCC) fee — As determined by MHCC under COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement fee, after October 1, 2015 — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013);</text> </paragraph> <paragraph num="D."> <text>Written verification of licensure fee — $25; and</text> </paragraph> <paragraph num="E."> <text>Replacement of license fee — $25</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Prohibited Conduct."> <paragraph num="A."> <text>Subject to the hearing provision of Health Occupations Article, §14-405, Annotated Code of Maryland, the disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensee or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of unprofessional or immoral conduct in the practice of perfusion;</text> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(6)"> <text>Is habitually intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully makes or files a false report or record in the practice of perfusion;</text> </paragraph> <paragraph num="(11)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report;</text> </paragraph> <paragraph num="(12)"> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="(13)"> <text>Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly makes a misrepresentation while practicing perfusion;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly practices perfusion with an unauthorized individual or aids an unauthorized individual in the practice of perfusion;</text> </paragraph> <paragraph num="(16)"> <text>Knowingly delegates a perfusion duty to an unlicensed individual;</text> </paragraph> <paragraph num="(17)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment or medicine;</text> </paragraph> <paragraph num="(18)"> <text>Is disciplined by a licensing or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the US Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </paragraph> <paragraph num="(19)"> <text>Fails to meet appropriate standards for the delivery of perfusion services;</text> </paragraph> <paragraph num="(20)"> <text>Knowingly submits false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(21)"> <text>Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes; and has:</text> <paragraph num="(a)"> <text>Surrendered the license, if any, issued by the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license, if any, issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(23)"> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes;</text> </paragraph> <paragraph num="(24)"> <text>Practices or attempts to practice beyond the authorized scope of practice;</text> </paragraph> <paragraph num="(25)"> <text>Is convicted of or pleads nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(26)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(27)"> <text>Practices or attempts to practice a perfusion procedure or uses or attempts to use perfusion equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; or</text> </paragraph> <paragraph num="(28)"> <text>Fails to cooperate with a lawful investigation of the Board.</text> </paragraph> <paragraph num="(29)"> <text>Fails to complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Crimes of Moral Turpitude.</text> <paragraph num="(1)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, the disciplinary panel shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the disciplinary panel shall order the revocation of a license on the certification by the Office of the Attorney General.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless the disciplinary panel agrees to accept the surrender of a license, a licensed perfusionist may not surrender the license nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Penalties."> <paragraph num="A."> <text>Except as otherwise provided in Health Occupations Article, §14-5E-01(g), Annotated Code of Maryland, an individual may not practice, attempt to practice, or offer to practice perfusion in this State unless licensed to practice perfusion by the Board.</text> </paragraph> <paragraph num="B."> <text>An individual who violates any provision of this chapter is subject to a civil fine of not more than $5,000 to be levied by the disciplinary panel.</text> </paragraph> <paragraph num="C."> <text>The Board shall pay any penalty collected under this regulation into the Board of Physicians Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Investigations, Hearings, and Appeals."> <paragraph num="A."> <text>A. Complaints alleging prohibited conduct shall be referred to the disciplinary panel to be investigated according to the disciplinary panel’s procedures.</text> </paragraph> <paragraph num="B."> <text>A hearing on charges issued under Regulation .14 of this chapter or Health Occupations Article, §14-5E-16(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5E-16 (c), Annotated Code of Maryland, or Regulation .14B of this chapter, shall be held in accordance with COMAR 10.32.02.08.</text> </paragraph> <paragraph num="D."> <text>Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5E-17, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Required Reports."> <paragraph num="A."> <text>Except as provided in §B, C, or F of this regulation, hospitals, related institutions, alternative health systems as defined in Health Occupations Article, §1-401, Annotated Code of Maryland, and employers shall file with the Board a report that the hospital, related institution, alternative health system, or employer limited, reduced, otherwise changed, or terminated any licensed perfusionist for any reason that might be grounds for disciplinary action under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, or any regulation in this chapter.</text> </paragraph> <paragraph num="B."> <text>If the action taken by a hospital, related institution, alternative health system, or employer under §A of this regulation relates to alcohol or drug impairment, the hospital, related institution, alternative health system or employer is not required to report the perfusionist to the Board if:</text> <paragraph num="(1)"> <text>The hospital, related institution, alternative health system, or employer knows that the licensed perfusionist is:</text> <paragraph num="(a)"> <text>In an alcohol or drug treatment program that is:</text> <paragraph num="(i)"> <text>Accredited by The Joint Commission or its successor; or</text> </paragraph> <paragraph num="(ii)"> <text>Certified by the Maryland Department of Health; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The perfusionist takes appropriate steps to permit the hospital, related institution, alternative health system, or employer to verify that the licensed perfusionist remains in the treatment program and is compliant with the requirements of that program until discharge; and</text> </paragraph> <paragraph num="(3)"> <text>The action of condition of the licensed perfusionist has not caused injury to an individual while the perfusionist is practicing as a licensed perfusionist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a licensed perfusionist enters or is considering entering an alcohol or drug treatment program that is accredited by The Joint Commission or its successor that is certified by the Maryland Department of Health, the licensed perfusionist shall notify the hospital, related institution, alternative health system, or employer of the licensed perfusionist’s decision to enter the treatment program.</text> </paragraph> <paragraph num="D."> <text>If the licensed perfusionist fails to provide the notice required under §C of this regulation, and the hospital, related institution, alternative health system, or employer learns that the licensed perfusionist has entered a treatment program, the hospital related institution, alternative health system, or employer shall report to the Board that the licensed perfusionist has:</text> <paragraph num="(1)"> <text>Entered a treatment program; and</text> </paragraph> <paragraph num="(2)"> <text>Failed to provide the required notice.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the perfusionist has failed to take appropriate steps or has failed to remain compliant under §B(2) of this regulation or has failed to provide the required notice under §C of this regulation, the perfusionist may not use his or her participation in the treatment program as a mitigating circumstance in any disciplinary action.</text> </paragraph> <paragraph num="F."> <text>Noncompliance.</text> <paragraph num="(1)"> <text>If the licensed perfusionist is found to be noncompliant with the treatment program’s policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, or employer of the licensed perfusionist’s noncompliance.</text> </paragraph> <paragraph num="(2)"> <text>On receipt of the notification required under §C of this regulation, the hospital, related institution, alternative health system, or employer of the licensed perfusionist shall report the licensed perfusionist’s noncompliance to the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A person as defined in Health Occupations Article, §14-101(h), Annotated Code of Maryland, is not required under this regulation to make any report that would be in violation of any federal or state law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records.</text> </paragraph> <paragraph num="H."> <text>The hospital, related institution, alternative health system, or employer shall submit a required report within 10 days of any action described in this regulation.</text> </paragraph> <paragraph num="I."> <text>A report made under this regulation is not subject to subpoena or discovery in a civil action other than a proceeding arising out of a hearing and decision of the Board under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Fines, Penalties, and Sanctioning."> <paragraph num="A."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>Sections A and B of this regulation and Regulation .19 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B of this regulation, for violations of Health Occupations Article §14-5E-16 Annotated Code of Maryland, listed in the sanctioning guidelines, the disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension not meeting the criteria for §A(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(d)"> <text>A fine listed in the sanctioning guidelines may be imposed in addition to, but not as a substitute for a sanction. If a fine is listed, then at least the minimum fine will be imposed in addition to the sanction.</text> </paragraph> <paragraph num="(e)"> <text>The imposition of a fine does not affect the making of the sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>The Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .19 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by the Board, the administrative prosecutor, and the licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Offenses Related to Continuing Education Credits.</text> <paragraph num="(1)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to continuing education credits, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5E-16(a)(1), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5E-16(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5E-16(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>Health Occupations Article, §14-5E-16(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon finding a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Licensees Previously Disciplined Under §C(1) of this regulation.</text> <paragraph num="(a)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense.</text> </paragraph> <paragraph num="(b)"> <text>The Board may not apply the sanction described in §C(1) of this regulation in determining a sanction for a licensee previously disciplined for an offense related to continuing education credits.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Offenses Related to Clinical Activity.</text> <paragraph num="(1)"> <text>Willful Falsification.</text> <paragraph num="(a)"> <text>If a licensee has willfully falsified an application with respect to clinical activities, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(i)"> <text>Health Occupations Article, §14-5E-16(a)(1), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, §14-5E-16(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Health Occupations Article, §14-5E-16(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>Health Occupations Article, §14-5E-16(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Licensees Previously Disciplined Under §D(1) of this regulation.</text> <paragraph num="(a)"> <text>Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> <paragraph num="(b)"> <text>The Board may not apply the sanction described in §D(1) of this regulation in determining as sanction for a licensee previously fined or disciplined for an offense related to criminal activities.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctioning Guidelines for Perfusionists."> <paragraph num="A."> <text>Subject to provisions of Regulation .18A and B of this chapter, the Board may impose sanctions as outlined in §B of this regulation on perfusionists for violations of Health Occupations Article, §14-5E-16, Annotated Code of Maryland, or Regulation .14 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-221, 1-606, 14-205, 14-5E-01 — 14-5E-20, and 14-5E-23, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 15, 2014 (41:18 Md. R. 1010)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D, E adopted effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective August 15, 2016 (43:16 Md. R. 900); January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B, C amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective August 15, 2016 (43:16 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A, C amended effective January 19, 2026 (53:1 Md. R, 21)</annotation> </annotations> </chapter> <chapter num="21" heading="Licensure, Regulation, and Discipline of Naturopathic Doctors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs how an individual becomes licensed as a naturopathic doctor and how naturopathic doctors are regulated and disciplined.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approved naturopathic medical program” means a naturopathic medical education program:</text> <paragraph num="(a)"> <text>In the United States that:</text> <paragraph num="(i)"> <text>Provides the degree of Doctor of Naturopathy or Doctor of Naturopathic Medicine;</text> </paragraph> <paragraph num="(ii)"> <text>Offers a 4-year graduate level full-time didactic and supervised clinical training;</text> </paragraph> <paragraph num="(iii)"> <text>Is accredited or has achieved candidacy status for accreditation, by the council on naturopathic medial education or an equivalent federally and Board recognized accrediting body for naturopathic medical education programs; and</text> </paragraph> <paragraph num="(iv)"> <text>Is part of an institution of higher education that is either accredited, or is a candidate for accreditation, by a regional or national institutional accrediting agency recognized by the United States Secretary of Education;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In a diploma-granting, degree-equivalent college or university in Canada that:</text> <paragraph num="(i)"> <text>Offers graduate level, full-time didactic and supervised clinical training; and</text> </paragraph> <paragraph num="(ii)"> <text>Is accredited, or has achieved candidacy status for accreditation, by the council of naturopathic medical education or an equivalent federally and Board recognized accrediting body for participation in government-funded student aid programs; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Has provincial approval for participation in government-funded student aid programs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Articular manipulation” means manipulation of the joints up to but not including manipulation beyond the elastic limit and exclusive of low amplitude, high velocity thrusts, also known as Grade V manipulations.</text> </paragraph> <paragraph num="(3)"> <text>“Attestation” means a statement of intent.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(5)"> <text>“Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(6)"> <text>“Collaborate” means a cooperative relationship between naturopathic doctors and licensed physicians, which does not imply or create a supervisory relationship between the licensed physician and the naturopathic doctor.</text> </paragraph> <paragraph num="(7)"> <text>“Collaboration and consultation agreement” means an agreement whereby a naturopathic doctor and physician will collaborate and consult regarding a patient’s care, but in which the:</text> <paragraph num="(a)"> <text>Patient does not enter the care of the consulted physician;</text> </paragraph> <paragraph num="(b)"> <text>Consultation does not create a physician-patient relationship; and</text> </paragraph> <paragraph num="(c)"> <text>Consulted physician does not direct patient care or engage directly in the care of the patient.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Committee” means the Naturopathic Medicine Advisory Committee.</text> </paragraph> <paragraph num="(9)"> <text>“Consult” or “consultation” means a process whereby a naturopathic doctor seeks the advice or opinion of a licensed or certified health care provider as needed in the treatment of a patient, which may include discussion of the:</text> <paragraph num="(a)"> <text>Patient’s diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Differential diagnoses and diagnostic method;</text> </paragraph> <paragraph num="(c)"> <text>Current naturopathic treatment;</text> </paragraph> <paragraph num="(d)"> <text>Patient’s response thus far to naturopathic treatment;</text> </paragraph> <paragraph num="(e)"> <text>Potential medical and other options outside the naturopathic doctors scope of practice that might benefit the patient;</text> </paragraph> <paragraph num="(f)"> <text>Patient’s potential response to diagnostic and treatment options outside the naturopathic doctor’s scope of practice; and</text> </paragraph> <paragraph num="(g)"> <text>Patient’s expected prognosis.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Corrective and orthopedic gymnastics” means therapeutic exercises, stretching, and other movement therapies intended to promote healing and rehabilitation.</text> </paragraph> <paragraph num="(11)"> <text>“Council” means the Naturopathic Doctors Formulary Council.</text> </paragraph> <paragraph num="(12)"> <text>“Criminal history records check” means the performance of both a State criminal history check by the Central Repository, and a national criminal history check by the Federal Bureau of Investigation.</text> </paragraph> <paragraph num="(13)"> <text>“Criminal history records information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, and convictions, and the disposition of pending criminal charges.</text> </paragraph> <paragraph num="(14)"> <text>“Diagnostic imaging” includes, but is not limited to, X-ray, ultrasound, mammogram, bone densitometry, computed tomography (CT scans), magnetic resonance imaging (MRI scans), endoscopic exam, and all other forms of nuclear imaging.</text> </paragraph> <paragraph num="(15)"> <text>“Electromagnetic energy” means electric and magnetic energy administered through the use of a therapeutic device, including, but not limited to, transcutaneous electrical nerve stimulation, microcurrent electrical muscle stimulation, diathermy, infrared, ultra-violet treatments, and other devices which utilize electrical or magnetic force for therapeutic effect.</text> </paragraph> <paragraph num="(16)"> <text>“Electrotherapy” means treatment through application of electric energy administered through the use of therapeutic devices, including, but not limited to, transcutaneous electrical nerve stimulation, microcurrent electrical neuromuscular stimulation, and other devices which utilize electrical force for therapeutic effect.</text> </paragraph> <paragraph num="(17)"> <text>Goods.</text> <paragraph num="(a)"> <text>“Goods” means items that can be sold.</text> </paragraph> <paragraph num="(b)"> <text>“Goods” includes, but is not limited to, natural medicines referenced in Health Occupations Article, §14-5F—14(a)(3) and (4), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Hydrotherapy.</text> <paragraph num="(a)"> <text>“Hydrotherapy” means external and internal applications of hot and cold water, ice, and steam for therapeutic purposes.</text> </paragraph> <paragraph num="(b)"> <text>“Hydrotherapy” includes, but is not limited to, hot or cold compresses, hydrocollator packs, hot or cold baths or showers involving the full body or specific body parts.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Licensed naturopathic doctor” means a naturopathic doctor who is licensed by the Board to practice naturopathic medicine.</text> </paragraph> <paragraph num="(20)"> <text>“Mechanical sciences of healing” means techniques and therapies which attempt to promote healing via mechanical or physical applications.</text> </paragraph> <paragraph num="(21)"> <text>“Mechanotherapy” means treatment by mechanical means including the use of durable medical and therapeutic devices.</text> </paragraph> <paragraph num="(22)"> <text>“Natural medicine” means medicine derived from mineral, animal, or botanical origin.</text> </paragraph> <paragraph num="(23)"> <text>“Naturopathic doctor” means an individual who practices naturopathic medicine.</text> </paragraph> <paragraph num="(24)"> <text>Naturopathic Medicine.</text> <paragraph num="(a)"> <text>“Naturopathic medicine” means the prevention, diagnosis, and treatment of human health conditions, injury, and disease using only patient education and naturopathic therapies and their therapeutic substances recognized by the council of naturopathic therapies and therapeutic substances recognized by the Council of Naturopathic Medical Education.</text> </paragraph> <paragraph num="(b)"> <text>“Naturopathic medicine” includes:</text> <paragraph num="(i)"> <text>Counseling;</text> </paragraph> <paragraph num="(ii)"> <text>The practice of the mechanical sciences of healing, including mechanotherapy, articular manipulations, corrective and orthopedic gymnastics, hydrotherapy, electrotherapy, and phototherapy; and</text> </paragraph> <paragraph num="(iii)"> <text>The practice of the material sciences of healing, including nutrition, phytotherapy, treatment by natural substances, and external applications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Naturopathic musculoskeletal mobilization” means the treatment by manual and other mechanical means of all body tissues exclusive of high-velocity thrusts at or beyond the end range of normal joint motion.</text> </paragraph> <paragraph num="(26)"> <text>“Non-bona-fide treatment” means when:</text> <paragraph num="(a)"> <text>A naturopathic doctor treats or examines a patient in a way that involves sexual contact when there is no medical reason for the procedure; or</text> </paragraph> <paragraph num="(b)"> <text>The procedure falls outside a naturopathic doctor’s scope of practice.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Phototherapy” means treatment through application of light, including visible light, ultraviolet light, infrared, natural sources of light, and artificial sources of light.</text> </paragraph> <paragraph num="(28)"> <text>Physiological Function Tests.</text> <paragraph num="(a)"> <text>“Physiological function tests” means all tests performed to assess and diagnose physiological processes in all bodily systems.</text> </paragraph> <paragraph num="(b)"> <text>“Physiological function tests” include, but are not limited to, respiratory testing, heart rate, percent body fat, body composition, and others, as consistent with naturopathic medical education.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Phytotherapy” means treatment by use of botanical medicines.</text> </paragraph> <paragraph num="(30)"> <text>“Prescription drug” means any drug defined in the federal Food, Drug, and Cosmetic Act, 21 U.S.C. §503(b), as amended, if the drug’s label is required to bear the statement “Rx only”.</text> </paragraph> <paragraph num="(31)"> <text>“Sexually exploitative relationship” means a naturopathic doctor taking advantage of an unequal relationship between the naturopathic doctor and patient, staff member, or student.</text> </paragraph> <paragraph num="(32)"> <text>“Therapeutic deception” means representation by a naturopathic doctor that sexual contact or sexual activity by or with a patient is consistent with or part of a patient’s treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Naturopathic Medicine Advisory Committee."> <paragraph num="A."> <text>The Committee shall consist of five members appointed by the Board as follows:</text> <paragraph num="(1)"> <text>Two members shall be individuals who:</text> <paragraph num="(a)"> <text>Practice naturopathic medicine;</text> </paragraph> <paragraph num="(b)"> <text>Are certified by the North American Board of Naturopathic Examiners;</text> </paragraph> <paragraph num="(c)"> <text>Have a minimum of 2 years’ experience in naturopathic medicine; and</text> </paragraph> <paragraph num="(d)"> <text>By March 1, 2016 or thereafter, are licensed as a naturopathic doctor;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>One member:</text> <paragraph num="(a)"> <text>Shall be a consumer member;</text> </paragraph> <paragraph num="(b)"> <text>Shall be a resident of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>May not be or ever have been licensed to practice a health occupation in Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>May not have a substantial personal, business, professional, or pecuniary connection with naturopathic education, business, or practice;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One member shall be a practicing:</text> <paragraph num="(a)"> <text>Licensed physician; or</text> </paragraph> <paragraph num="(b)"> <text>Doctor of osteopathy who is a member of the Board; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>One member shall be a practicing licensed physician or practicing licensed doctor of osteopathy with experience working with naturopathic doctors by having met one or more of the following criteria:</text> <paragraph num="(a)"> <text>Worked in the same clinical practice as a licensed naturopathic doctor;</text> </paragraph> <paragraph num="(b)"> <text>Named in an attestation submitted by a licensed naturopathic doctor;</text> </paragraph> <paragraph num="(c)"> <text>Employed by a naturopathic medicine program accredited by the Council on Naturopathic Medical Education;</text> </paragraph> <paragraph num="(d)"> <text>Worked with, or supervised, a naturopathic resident completing a naturopathic medical residency accredited by the Council on Naturopathic Medical Education;</text> </paragraph> <paragraph num="(e)"> <text>Graduated from a naturopathic medical program accredited by the Council on Naturopathic Medical Education and holding a naturopathic doctor or naturopathic physician license in any state that licenses Naturopathic Doctors or Naturopathic Medical Doctors in addition to holding a medical doctorate or doctor of osteopathy physician’s license;</text> </paragraph> <paragraph num="(f)"> <text>Was a Diplomate of the American Board of Integrative Medicine, a graduate of any fellowship program in Integrative Medicine approved by the American Board of Integrative Medicine, a graduate of any fellowship program in Integrative Medicine approved by the American Board of Medical Specialties, or a diplomate of the American Board of Integrative Holistic Medicine; or</text> </paragraph> <paragraph num="(g)"> <text>Accrued at least 20 Category 1 continuing medical education credits, in the 2 years before serving, in topics of natural, nutritional, holistic or integrative medicine delivered by a professional association whose primary mission is the advancement of one of these fields.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>On request, review selected applications for licensure or reinstatement of naturopathic doctors and make recommendations to the Board as to what action to take on the applications;</text> </paragraph> <paragraph num="(2)"> <text>Review each written attestation;</text> </paragraph> <paragraph num="(3)"> <text>Make recommendations to the Board regarding regulations governing naturopathic doctors;</text> </paragraph> <paragraph num="(4)"> <text>Advise the Board on matters related to the practice of naturopathic medicine;</text> </paragraph> <paragraph num="(5)"> <text>Develop and recommend to the Board examination standards consistent with the statutory requirement;</text> </paragraph> <paragraph num="(6)"> <text>Develop and recommend to the Board a code of ethics for licensed naturopathic doctors; and</text> </paragraph> <paragraph num="(7)"> <text>Develop and recommend to the Board continuing education requirements for license renewal and reinstatement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Naturopathic Doctors Formulary Council."> <paragraph num="A."> <text>The Council consists of the following members:</text> <paragraph num="(1)"> <text>The Deputy Secretary for Public Health Services or the Deputy Secretary’s designee; and</text> </paragraph> <paragraph num="(2)"> <text>The following members, appointed by the Board:</text> <paragraph num="(a)"> <text>Two individuals who:</text> <paragraph num="(i)"> <text>Are licensed in the State as naturopathic doctors;</text> </paragraph> <paragraph num="(ii)"> <text>Practice naturopathic medicine in the State;</text> </paragraph> <paragraph num="(iii)"> <text>Are certified by the North American Board of Naturopathic Examiners; and</text> </paragraph> <paragraph num="(iv)"> <text>Have a minimum of 2 years experience;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Two licensed physicians who practice in the State;</text> </paragraph> <paragraph num="(c)"> <text>One pharmacist who has a background in pharmacognosy and who practices in the State; and</text> </paragraph> <paragraph num="(d)"> <text>One consumer of naturopathic services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Term of Appointment—Naturopathic Doctors Formulary Council.</text> <paragraph num="(1)"> <text>The term of an appointed member of the Council is 4 years and is staggered.</text> </paragraph> <paragraph num="(2)"> <text>At the end of a term, an appointed member continues to serve until a successor is appointed.</text> </paragraph> <paragraph num="(3)"> <text>An individual may be reappointed for a second 4-year term but may not serve more than two consecutive 4-year terms.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The terms of the initial members of the Naturopathic Doctors Formulary Council shall expire as follows:</text> <paragraph num="(1)"> <text>In 2025:</text> <paragraph num="(a)"> <text>One naturopathic doctor member;</text> </paragraph> <paragraph num="(b)"> <text>One physician member; and</text> </paragraph> <paragraph num="(c)"> <text>The consumer member; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In 2027:</text> <paragraph num="(a)"> <text>One naturopathic doctor member;</text> </paragraph> <paragraph num="(b)"> <text>One physician member, and</text> </paragraph> <paragraph num="(c)"> <text>The pharmacist member.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A member of the Council may not receive compensation as a member of the Council, but is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.</text> </paragraph> <paragraph num="E."> <text>The Board shall designate the chair of the Council, whose term of office of the chair is 2 years.</text> </paragraph> <paragraph num="F."> <text>The Board shall provide staff for the Council.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-2" heading="Naturopathic Doctors Formulary Council and Board Duties."> <paragraph num="A."> <text>Council Duties.</text> <paragraph num="(1)"> <text>The Council shall:</text> <paragraph num="(a)"> <text>Develop and recommend to the Board a formulary for use by licensed naturopathic doctors;</text> </paragraph> <paragraph num="(b)"> <text>Annually review the formulary adopted by the Board under §B(2) of this regulation to determine if any changes are necessary for compliance with current prescribing standards or the practice of naturopathic medicine;</text> </paragraph> <paragraph num="(c)"> <text>Otherwise review the formulary at the direction of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Make recommendations to the Board based on the reviews conducted under this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall adopt a formulary based on the Council's recommendations under this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Board Duties.</text> <paragraph num="(1)"> <text>The Board may modify or reject any recommendation of the Council regarding the formulary.</text> </paragraph> <paragraph num="(2)"> <text>The formulary adopted by the Board shall be in accordance with Health Occupations Article, §14-5F-04.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Initial Licensure."> <paragraph num="A."> <text>To qualify for a license, an applicant shall meet the following requirements:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be at least 21 years of age;</text> </paragraph> <paragraph num="(3)"> <text>Have a doctorate in naturopathic medicine from an approved naturopathic medical program;</text> </paragraph> <paragraph num="(4)"> <text>Pass a competency based national naturopathic licensing examination part I and part II administered by the North American Board of Naturopathic Examiners or its successor agency that is consistent with federal standards of education and training;</text> </paragraph> <paragraph num="(5)"> <text>Be physically and mentally capable of safely practicing naturopathic medicine with or without reasonable accommodation; and</text> </paragraph> <paragraph num="(6)"> <text>If an applicant is licensed, certified, or registered to practice naturopathic medicine or any other health occupation in another state, be in good standing with the applicable state licensing, certification, or registration authority.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To apply for a license, an applicant shall:</text> <paragraph num="(1)"> <text>Submit an application to the Board on a form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board an initial application fee as specified in Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Submit to the Board a written attestation as provided in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>If the applicant has been licensed, certified, or registered to practice naturopathic medicine in another state, submit all evidence relating to:</text> <paragraph num="(a)"> <text>Any disciplinary action taken or any administrative penalties assessed against the applicant by the appropriate state licensing, certification, or registration authority; and</text> </paragraph> <paragraph num="(b)"> <text>Any consent agreements into which the applicant entered that contain conditions placed on the applicant’s professional conduct and practice, including any voluntary surrender of a license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Additional Requirements. An applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository:</text> <paragraph num="(1)"> <text>Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and</text> </paragraph> <paragraph num="(2)"> <text>All fees required by the Central Repository and the Federal Bureau of Investigation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall issue a license to an applicant who meets the requirements of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Collaboration and Consultation Agreement and the Written Attestation."> <paragraph num="A."> <text>A collaboration and consultation agreement shall:</text> <paragraph num="(1)"> <text>Include the name and license number of the physician with whom the applicant has the collaboration and consultation agreement;</text> </paragraph> <paragraph num="(2)"> <text>State that the applicant will require patients to sign a consent form in plain language that:</text> <paragraph num="(a)"> <text>The naturopathic doctor’s practice of naturopathic medicine is limited to the scope of practice identified in Health Occupations Article, §14-5F-14, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Describes the differences in scope of practice between naturopathic doctors and physicians;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>State that naturopathic doctors shall refer patients to and consult with physicians and other health care providers licensed or certified under the Health Occupations Article as needed; and</text> </paragraph> <paragraph num="(4)"> <text>State that in cases where the naturopathic doctor diagnoses a patient with a life threatening condition, the naturopathic doctor shall:</text> <paragraph num="(a)"> <text>Counsel and discuss with the patient the potential benefits offered by other physicians or other healthcare professionals; and</text> </paragraph> <paragraph num="(b)"> <text>Attempt to make the appropriate referral.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall complete and submit to the Board a written attestation on a form supplied by the Board that states that the applicant has a collaboration and consultation agreement:</text> <paragraph num="(1)"> <text>With a physician that is licensed in this State under Health Occupations Article, Title 14, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>That meets the requirements of §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant shall inform the physician named as a collaborating physician in the attestation that the physician has been named.</text> </paragraph> <paragraph num="D."> <text>A licensee shall maintain a collaboration and consultation agreement that meets the requirements of this regulation in order to practice naturopathic medicine in the State.</text> </paragraph> <paragraph num="E."> <text>A licensee shall comply with the requirements of the licensee’s collaboration and consultation agreement with a physician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Documentation for Initial Licensure."> <paragraph num="A."> <text>The applicant shall submit an application on a form supplied by the Board.</text> </paragraph> <paragraph num="B."> <text>A completed application shall include:</text> <paragraph num="(1)"> <text>Verification of naturopathic medical education;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of successful completion of the examination requirements as described in Regulation .04A(4) of this chapter, including submission of all of the applicant’s scores sent directly to the Board from the examination authority or authorities;</text> </paragraph> <paragraph num="(3)"> <text>A statement from the applicant listing all disciplinary or adverse actions taken against the applicant by a:</text> <paragraph num="(a)"> <text>Hospital, related institution, alternative health system, or employer;</text> </paragraph> <paragraph num="(b)"> <text>Medical board;</text> </paragraph> <paragraph num="(c)"> <text>Licensing authority;</text> </paragraph> <paragraph num="(d)"> <text>Court; or</text> </paragraph> <paragraph num="(e)"> <text>Adjudicatory body;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>All application and licensing fees payable to the Board at the time the application is submitted to the Board;</text> </paragraph> <paragraph num="(5)"> <text>The applicant’s Social Security number, which the Board shall use only for evaluation and identification of applicants and licensees, but may not disclose in any other context;</text> </paragraph> <paragraph num="(6)"> <text>Verification of licensure from all states where the applicant has ever held a license;</text> </paragraph> <paragraph num="(7)"> <text>Verification of voluntary licensure nonrenewal or voluntary surrender of license while the applicant was in good standing and not under disciplinary charges or investigation at the time the license was surrendered from states where the applicant no longer holds a license;</text> </paragraph> <paragraph num="(8)"> <text>A passport quality photograph;</text> </paragraph> <paragraph num="(9)"> <text>Information in the National Practitioner Data Bank including, but not limited to, the following:</text> <paragraph num="(a)"> <text>Medical malpractice judgments against the applicant;</text> </paragraph> <paragraph num="(b)"> <text>Settlements made by the applicant in naturopathic medical malpractice actions; and</text> </paragraph> <paragraph num="(c)"> <text>Actions taken against the applicant or the applicant’s license by state disciplinary or licensing authorities;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Documentation of competency in English by any of the following:</text> <paragraph num="(a)"> <text>Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of graduation from a recognized English-speaking professional school;</text> </paragraph> <paragraph num="(c)"> <text>Documentation of a passing score on the naturopathic licensing examination administered by the North American Board of Naturopathic Examiners; or</text> </paragraph> <paragraph num="(d)"> <text>Documentation of receiving:</text> <paragraph num="(i)"> <text>A score of at least 26 on the “Speaking Section” of the Internet-Based Test of English as a Foreign Language; or</text> </paragraph> <paragraph num="(ii)"> <text>A score of Advanced or higher on the Oral Proficiency Interview;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>A chronological list of:</text> <paragraph num="(a)"> <text>All activities, beginning with the date of completion of naturopathic medical school through the date of application, listed by month and year, that account for all periods of time, and include each job held, regardless of whether the job was:</text> <paragraph num="(i)"> <text>Medically related or not; and</text> </paragraph> <paragraph num="(ii)"> <text>Compensated or not;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any other activity engaged in, including all periods of unemployment;</text> </paragraph> <paragraph num="(c)"> <text>Any actions, by a state licensing or disciplinary board, or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal;</text> </paragraph> <paragraph num="(d)"> <text>Any actions taken against the naturopathic doctor’s license, by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Any investigation or charge brought against the naturopathic doctor by a licensing or disciplinary body or comparable body in the armed services;</text> </paragraph> <paragraph num="(f)"> <text>Any medical or health professional license for which the naturopathic doctor has applied if the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(g)"> <text>Any investigation or charge brought against the naturopathic doctor by a hospital, related institution, or alternative health care system that would be grounds for action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act including:</text> <paragraph num="(a)"> <text>A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances; and</text> </paragraph> <paragraph num="(b)"> <text>An arrest which would provide a basis for investigation or charge which would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>A physical or mental condition that currently impairs the naturopathic doctor’s ability to practice medicine;</text> </paragraph> <paragraph num="(14)"> <text>The filing or settling of a medical malpractice action in which the naturopathic doctor is, or has been, named as a defendant within the past 5 years;</text> </paragraph> <paragraph num="(15)"> <text>The following additional information:</text> <paragraph num="(a)"> <text>Copies of the complaints, pleadings, and judgments in all malpractice claims if the applicant has had 3 or more claims in the 5 years before the filing of the application for licensure;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all arrests, disciplinary actions, judgments, and final orders which occurred or were issued within the 7 years before submitting the application for licensure for driving while intoxicated, driving while under the influence of a chemical substance or medication, or any license probation, suspension, or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>All naturopathic medical licensure, certification, and recertification examination results and the dates when these examinations were taken;</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>If required by the Board and at the applicant’s expense, a physical or mental examination, or both, by a physician or evaluation program for treatment of impaired naturopathic doctors, or both, chosen by the Board to determine the applicant’s ability to practice naturopathic medicine;</text> </paragraph> <paragraph num="(17)"> <text>On forms supplied by the Board, a release granting the Board access to relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to:</text> <paragraph num="(a)"> <text>The National Practitioner Data Bank;</text> </paragraph> <paragraph num="(b)"> <text>Hospitals; and</text> </paragraph> <paragraph num="(c)"> <text>Other licensing bodies;</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>On forms supplied by the Board, a release of any information which is not statutorily protected;</text> </paragraph> <paragraph num="(19)"> <text>Certificates and verifications from the certifying or verifying authority sent directly from: the national licensing authority, the naturopathic educational institution, and other state’s licensing boards to the Board for applicants;</text> </paragraph> <paragraph num="(20)"> <text>The certified translation of any of the documents required under this chapter, at the applicant’s expense, for any documents required by this chapter that are in a language other than English; and</text> </paragraph> <paragraph num="(21)"> <text>The criminal history records information received from the Central Repository in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, and Regulation .04C(1) of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application Processing.</text> <paragraph num="(1)"> <text>The Board has designated a 4-month period for acting on applications as follows:</text> <paragraph num="(a)"> <text>Within 60 days after receipt of an application, the Board shall determine whether an application is complete;</text> </paragraph> <paragraph num="(b)"> <text>If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(c)"> <text>On receipt of the notice, the applicant shall correct the deficiency within 60 days or any other period specified in the notice; and</text> </paragraph> <paragraph num="(d)"> <text>If the applicant fails to correct the deficiency within the required period, the application will be closed and the applicant shall be required to:</text> <paragraph num="(i)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(ii)"> <text>Pay the required fees specified in Regulation .20 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not issue a license until the Board has:</text> <paragraph num="(a)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(b)"> <text>Approved the application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Withdrawal of Application.</text> <paragraph num="(1)"> <text>An applicant may not withdraw an application for initial licensure, renewal of a license, or reinstatement of a license without permission of the Board, if:</text> <paragraph num="(a)"> <text>The applicant is currently charged in another jurisdiction with conduct which would be grounds for discipline under the Health Occupations Article, §14-5F-18, Annotated Code of Maryland, if the applicant were licensed in this State;</text> </paragraph> <paragraph num="(b)"> <text>The applicant is under investigation in another jurisdiction for an allegation concerning conduct that would be grounds for discipline under Health Occupations Article, §14-5F-18, Annotated Code of Maryland, if the applicant were licensed in this State; or</text> </paragraph> <paragraph num="(c)"> <text>The Board is investigating the applicant or application or has issued a notice of intent to deny licensure.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In determining whether to allow the withdrawal of a licensure application, the Board may consider such factors as the following:</text> <paragraph num="(a)"> <text>Issues of competence or conduct which caused the matter to be investigated;</text> </paragraph> <paragraph num="(b)"> <text>Duty to protect the public in other jurisdictions from duplicative expenditures on investigation of licensure applications; and</text> </paragraph> <paragraph num="(c)"> <text>Truthfulness of the applicant during the application process.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Exceptions to Licensure Requirements."> <text>The following individuals do not need to be licensed in order to practice naturopathy in Maryland:</text> <paragraph num="A."> <text>An individual who is employed by the United States Government to practice naturopathic medicine while practicing within the scope of that employment;</text> </paragraph> <paragraph num="B."> <text>A student who is enrolled in an approved naturopathic medical program while the student is participating in a course of study under the supervision of a licensed naturopathic doctor or a licensed professional in the field of study;</text> </paragraph> <paragraph num="C."> <text>An individual who is licensed in another state to practice naturopathic medicine in the state for purposes of litigation may examine a patient, offer recommendations, and provide testimony; or</text> </paragraph> <paragraph num="D."> <text>A naturopathic doctor licensed by and residing in another jurisdiction, if the naturopathic doctor is engaged in consultation with the naturopathic doctor in the state about a particular patient and does not direct patient care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Scope of Practice."> <text>A license authorizes a licensee, consistent with naturopathic education, training, and competence demonstrated by passing the Naturopathic Physician Licensing Examination, to:</text> <paragraph num="A."> <text>Order and perform physical and laboratory examinations for diagnostic purposes consistent with the education and training of naturopathic doctors, including:</text> <paragraph num="(1)"> <text>Phlebotomy;</text> </paragraph> <paragraph num="(2)"> <text>Clinical laboratory tests;</text> </paragraph> <paragraph num="(3)"> <text>Orifical examinations;</text> </paragraph> <paragraph num="(4)"> <text>Electrocardiograms with over read by a cardiologist; and</text> </paragraph> <paragraph num="(5)"> <text>Physiological function tests;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Order diagnostic imaging studies, interpret the diagnostic imaging reports and have access to the images from these studies. Naturopathic doctors shall not perform the imaging procedures nor directly interpret the images themselves;</text> </paragraph> <paragraph num="C."> <text>Dispense, order, or administer natural medicines, including, but not limited to, food, extracts of food, nutraceuticals, vitamins, amino acids, minerals, enzymes, botanicals and their extracts, and botanical medicines, homeopathic medicines and all dietary supplements and nonprescription drugs as defined by the Federal Food, Drug, and Cosmetic Act, as follows:</text> <paragraph num="(1)"> <text>Except for intravenous administration, the naturopathic doctor may order or dispense natural medicines that use various routes of administration, including:</text> <paragraph num="(a)"> <text>Oral;</text> </paragraph> <paragraph num="(b)"> <text>Nasal;</text> </paragraph> <paragraph num="(c)"> <text>Auricular;</text> </paragraph> <paragraph num="(d)"> <text>Ocular;</text> </paragraph> <paragraph num="(e)"> <text>Rectal;</text> </paragraph> <paragraph num="(f)"> <text>Vaginal;</text> </paragraph> <paragraph num="(g)"> <text>Transdermal; and</text> </paragraph> <paragraph num="(h)"> <text>Intramuscular; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The naturopathic doctor may only administer natural medicines through transdermal administration;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Administer or perform hot or cold hydrotherapy, naturopathic physical medicine, electromagnetic energy and therapeutic exercise for the purpose of providing basic therapeutic care services, except that if a referral to another licensed provider is appropriate for ongoing rehabilitation or habilitation services, the naturopathic doctor shall make the referral;</text> </paragraph> <paragraph num="E."> <text>Provide health education and health counseling; and</text> </paragraph> <paragraph num="F."> <text>Perform naturopathic musculoskeletal mobilization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Prohibited Actions."> <text>An individual who is solely licensed as a naturopathic doctor may not:</text> <paragraph num="A."> <text>Prescribe, dispense, or administer any prescription drug;</text> </paragraph> <paragraph num="B."> <text>Perform surgical procedures;</text> </paragraph> <paragraph num="C."> <text>Unless licensed under the Health Occupations Article, Annotated Code of Maryland, practice or claim to practice as:</text> <paragraph num="(1)"> <text>A medical doctor or physician;</text> </paragraph> <paragraph num="(2)"> <text>An osteopath;</text> </paragraph> <paragraph num="(3)"> <text>A dentist;</text> </paragraph> <paragraph num="(4)"> <text>A podiatrist;</text> </paragraph> <paragraph num="(5)"> <text>An optometrist;</text> </paragraph> <paragraph num="(6)"> <text>A psychologist;</text> </paragraph> <paragraph num="(7)"> <text>A nurse practitioner;</text> </paragraph> <paragraph num="(8)"> <text>A physician assistant;</text> </paragraph> <paragraph num="(9)"> <text>A chiropractor;</text> </paragraph> <paragraph num="(10)"> <text>A physical therapist;</text> </paragraph> <paragraph num="(11)"> <text>An acupuncturist; or</text> </paragraph> <paragraph num="(12)"> <text>Any other health care professional;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Use general or spinal anesthetics;</text> </paragraph> <paragraph num="E."> <text>Administer ionizing radioactive substances for therapeutic purposes;</text> </paragraph> <paragraph num="F."> <text>Perform chiropractic adjustments or manipulations that include high velocity thrusts at or beyond the end range of normal joint motion unless the licensee is also a licensed chiropractor; or</text> </paragraph> <paragraph num="G."> <text>Perform acupuncture unless the licensee is also a licensed acupuncturist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewals and Reinstatement."> <paragraph num="A."> <text>Renewals.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment.</text> </paragraph> <paragraph num="(2)"> <text>The term of a license renewed by the Board is 2 years from the date of renewal.</text> </paragraph> <paragraph num="(3)"> <text>A license expires at the end of its term unless the license is renewed as provided by the Board.</text> </paragraph> <paragraph num="(4)"> <text>At least 1 month before the license expires, the Board shall send to the licensee a renewal notice that states:</text> <paragraph num="(a)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(b)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued before the license expires; and</text> </paragraph> <paragraph num="(c)"> <text>The amount of the renewal fee as specified in Regulation .20 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Board shall renew the license of a licensee who:</text> <paragraph num="(a)"> <text>Submits a renewal application on the form that the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>Pays a renewal fee as specified in Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(d)"> <text>Meets the continuing education requirements as set forth in Regulation 11 of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Provides evidence of biennial cardiopulmonary resuscitation certification; and</text> </paragraph> <paragraph num="(f)"> <text>Attests that the licensee has a current collaboration and consultation agreement with a physician licensed in the State that meets the requirements of Regulation .05 of this chapter at the time of renewal..</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The failure to receive a renewal notice does not excuse a licensee from complying with §A(3) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reinstatement of an Expired or Lapsed License. An individual applying for reinstatement of a license to practice naturopathic medicine who failed to renew for any reason shall:</text> <paragraph num="(1)"> <text>Complete a reinstatement application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the Board the reinstatement fee set by the Board in accordance with Regulation .20 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Complete a criminal history records check in accordance with Health Occupations Article §14-308.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Provide documentation of completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement; and</text> </paragraph> <paragraph num="(5)"> <text>Attest that the licensee has a current collaboration and consultation agreement with a physician licensed in the State that meets the requirements of Regulation .05 of this chapter at the time of reinstatement.</text> </paragraph> <paragraph num="(6)"> <text>Meet any additional requirements set by the Board for reinstatement of a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement after Revocation of a License or After a Lapse in Renewal.</text> <paragraph num="(1)"> <text>On the application of an individual whose license has been revoked, the disciplinary panel, on the affirmative vote of a majority of the quorum, may, in its discretion, reinstate a revoked license.</text> </paragraph> <paragraph num="(2)"> <text>When a time period is not stated in an order for revocation, the disciplinary panel may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order.</text> </paragraph> <paragraph num="(3)"> <text>The disciplinary panel may not entertain an application for post-disciplinary reinstatement after an order of revocation unless:</text> <paragraph num="(a)"> <text>Any time period stated in the order has expired;</text> </paragraph> <paragraph num="(b)"> <text>Any condition set out in the order has been fulfilled;</text> </paragraph> <paragraph num="(c)"> <text>The applicant has filed a formal application and paid the fee set by the Board in Regulation .20 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>The applicant meets all of the requirements for reinstatement set out in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The disciplinary panel shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B.</text> </paragraph> <paragraph num="(5)"> <text>A revocation of a license may not be for less than 1 year.</text> </paragraph> <paragraph num="(6)"> <text>The disciplinary panel may not entertain applications for reinstatement if a revocation is permanent.</text> </paragraph> <paragraph num="(7)"> <text>The applicant shall meet any additional requirements set by the Board for reinstatement of a license.</text> </paragraph> </paragraph> <paragraph num="D."> <text>After the expiration date of the license, the naturopathic doctor is no longer licensed to practice naturopathic medicine.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Continuing Education Requirements."> <paragraph num="A."> <text>Requirements. A licensed naturopathic doctor shall take at least 50 hours of continuing education credits during every 2-year renewal period:</text> <paragraph num="(1)"> <text>For license renewal, preceding the expiration of the license for a naturopathic doctor; or</text> </paragraph> <paragraph num="(2)"> <text>For license reinstatement, preceding the date of the submission of the application for reinstatement.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The courses selected shall be approved by any of the following:</text> <paragraph num="(1)"> <text>The American Association of Naturopathic Physicians;</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Association of Naturopathic Physicians;</text> </paragraph> <paragraph num="(3)"> <text>The Accreditation Council for Continuing Medical Education;</text> </paragraph> <paragraph num="(4)"> <text>The Accreditation Council for Pharmacy Education;</text> </paragraph> <paragraph num="(5)"> <text>The North American Naturopathic Continuing Education Accreditation Council; or</text> </paragraph> <paragraph num="(6)"> <text>A naturopathic doctor’s licensing authority or professional association of another state which meets the standards adopted by the American Association of Naturopathic Physicians.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Grounds for Discipline."> <text>Subject to the hearing provisions Health Occupations Article, §14-405, Annotated Code of Maryland, the Board, on the affirmative vote of a majority of its members then serving as a quorum of the Board, may deny a license to any applicant, or a disciplinary panel, on the affirmative vote of a majority of a quorum of the disciplinary panel, may reprimand any licensee, place any licensee on probation, or suspend or revoke a license of any licensee if the applicant or licensee:</text> <paragraph num="A."> <text>Is habitually intoxicated, or is addicted to or habitually abuses any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any drug without a valid prescription or indication, or provides professional services while under the influence of alcohol or using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Has been found to be mentally incompetent by a physician if the mental incompetence impairs the ability of the applicant or licensee to undertake the practice of naturopathic medicine in a manner consistent with the safety of the public;</text> </paragraph> <paragraph num="C."> <text>Has entered into a consent agreement with or has been assessed an administrative penalty by a licensing authority in another state;</text> </paragraph> <paragraph num="D."> <text>Fraudulently or deceptively obtains, or attempts to obtain, or uses a license for the applicant, the licensee, or another;</text> </paragraph> <paragraph num="E."> <text>Has a license revoked or suspended, or was otherwise acted against, including the denial of licensure, by the licensing authority of another state;</text> </paragraph> <paragraph num="F."> <text>Uses false, deceptive, or misleading advertising;</text> </paragraph> <paragraph num="G."> <text>Advertises, practices, or attempts to practice under a name other than the applicant’s or licensee’s own name;</text> </paragraph> <paragraph num="H."> <text>Aids, assists, employs, or advises any unlicensed individual to practice naturopathic medicine;</text> </paragraph> <paragraph num="I."> <text>Willfully makes or files a false report or record in the practice of naturopathic medicine;</text> </paragraph> <paragraph num="J."> <text>Willfully or negligently fails to file a report or record as required by law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report;</text> </paragraph> <paragraph num="K."> <text>Pays or receives any commission, bonus, kickback, or rebate, or engages in any split-fee arrangement in any form with a licensed physician, organization, agency, or other person, either directly or indirectly, for patients referred to health care providers;</text> </paragraph> <paragraph num="L."> <text>Exercises influence within a patient-doctor relationship for purposes of engaging a patient in sexual activity;</text> </paragraph> <paragraph num="M."> <text>Engages in sexual misconduct with a patient;</text> </paragraph> <paragraph num="N."> <text>Fails to keep written medical records justifying the course of treatment of a patient;</text> </paragraph> <paragraph num="O."> <text>Engages in an act or omission that does not meet generally accepted standards of practice of naturopathic medicine or of safe care of patients, whether or not actual injury to a patient is established;</text> </paragraph> <paragraph num="P."> <text>Delegates professional responsibilities to an individual when the licensee delegating the responsibilities knows or has reason to know that the individual is not qualified by training, experience, or licensure to perform the responsibilities;</text> </paragraph> <paragraph num="Q."> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="R."> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="S."> <text>Is guilty of unprofessional or immoral conduct in the practice of naturopathic medicine;</text> </paragraph> <paragraph num="T."> <text>Offers, undertakes, or agrees to cure or treat a disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="U."> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="V."> <text>Sells, prescribes, gives away, or administers drugs for illegal or illegitimate purposes;</text> </paragraph> <paragraph num="W."> <text>Denies or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="X."> <text>Fails to cooperate with a lawful investigation of the Board;</text> </paragraph> <paragraph num="Y."> <text>Abandons a patient; or</text> </paragraph> <paragraph num="Z."> <text>Violates any provision of this title or this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>Subject to provisions of Regulation .09A and B of this chapter, the disciplinary panel may impose sanctions as outlined in §B of this regulation on physicians for violations of Health Occupations Article, §§1-302, 14-404(a), and 14-504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Investigations and Hearings."> <paragraph num="A."> <text>Except as otherwise provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, before the Board or a disciplinary panel takes any action under Health Occupations Article, §14-5F-18(a), Annotated Code of Maryland, the Board shall give the individual against whom the action is contemplated an opportunity for a hearing before the Board or disciplinary panel in accordance with the hearing requirements of Health Occupations Article, §14-405, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Crime Involving Moral Turpitude.</text> <paragraph num="(1)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, a disciplinary panel shall order the suspension of a license if the licensee is convicted or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(2)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, a disciplinary panel shall order the revocation of a license on the certification by the office of the attorney general.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall investigate any complaint filed with the Board that alleges that there are grounds for action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>An investigation and any reports and recommendations related to the investigation are confidential, subject to the exceptions under §E of this regulation.</text> </paragraph> <paragraph num="E."> <text>On the request of a person who has made a complaint to the Board, the Board shall provide the person with information on the status of the complaint.</text> </paragraph> <paragraph num="F."> <text>The Board shall give notice and the Board or disciplinary panel hold the hearing in accordance with the Administrative Procedure Act.</text> </paragraph> <paragraph num="G."> <text>The individual may be represented at the hearing by counsel.</text> </paragraph> <paragraph num="H."> <text>Over the signature of an officer or the administrator of the Board or disciplinary panel, the Board or disciplinary panel may issue subpoenas and administer oaths in connection with any investigation under Health Occupations Article, §14-5F-18, Annotated Code of Maryland, and any hearings or proceedings before the Board or disciplinary panel.</text> </paragraph> <paragraph num="I."> <text>If, without lawful excuse, a person disobeys a subpoena from the Board or an order by the Board to take an oath or to testify or answer a question, then, on petition of the Board, a court of competent jurisdiction may punish the person as for contempt of court.</text> </paragraph> <paragraph num="J."> <text>If, after due notice, the individual against whom the action is contemplated fails or refuses to appear, the Board or disciplinary panel may hear and determine the matter.</text> </paragraph> <paragraph num="K."> <text>Appeal.</text> <paragraph num="(1)"> <text>Any person aggrieved by a final decision of the Board or a disciplinary panel under Health Occupations Article, §14-5F-01 et seq., Annotated Code of Maryland, in a contested case, as defined in the Administrative Procedure Act, may take a direct judicial appeal.</text> </paragraph> <paragraph num="(2)"> <text>The appeal shall be made as provided for judicial review of final decisions in the Administrative Procedure Act.</text> </paragraph> <paragraph num="(3)"> <text>An order of the Board or a disciplinary panel may not be stayed pending judicial review.</text> </paragraph> <paragraph num="(4)"> <text>The Board may appeal from any decision that reverses or modifies an order of the Board or a disciplinary panel.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The Board may issue a cease and desist order for:</text> <paragraph num="(1)"> <text>Practicing naturopathic medicine without a license or with an unauthorized person; or</text> </paragraph> <paragraph num="(2)"> <text>Supervising or aiding an unauthorized person in the practice of naturopathic medicine.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Cost of Bringing an Action Against a Licensee."> <paragraph num="A."> <text>If, after a hearing, a licensee is found to have violated provisions of Health Occupations Article, §14-5F-18, Annotated Code of Maryland, the Board shall impose a fee on the licensee that shall approximate the Board’s cost of bringing the proceedings against the licensee.</text> </paragraph> <paragraph num="B."> <text>The hearing costs may include any or all of the following expense items:</text> <paragraph num="(1)"> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="(2)"> <text>Transcriptions of the hearing record by court reporters;</text> </paragraph> <paragraph num="(3)"> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="(4)"> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="(5)"> <text>Hearing-related per diems and expenses for Board members; or</text> </paragraph> <paragraph num="(6)"> <text>Any other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Unauthorized Practice of Naturopathic Medicine and Title and Identification as Naturopathic Doctor."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, an individual may not practice, attempt to practice, or offer to practice naturopathic medicine in this State without a license. An individual who violates this section:</text> <paragraph num="(1)"> <text>Is guilty of a felony and upon conviction is subject to a fine not exceeding $10,000 or imprisonment not exceeding 5 years or both; and</text> </paragraph> <paragraph num="(2)"> <text>Is subject to a civil fine of no more than $50,000 to be levied by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless an individual is licensed to practice naturopathic medicine, the individual may not:</text> <paragraph num="(1)"> <text>Represent to the public by title, by description, of service, methods, or procedures, or otherwise, that the individual is licensed by the Board to practice naturopathic medicine;</text> </paragraph> <paragraph num="(2)"> <text>Use the title “doctor of naturopathic medicine”, “doctor of naturopathy”, naturopathic doctor”, or “naturopath”; or</text> </paragraph> <paragraph num="(3)"> <text>Use the initials “N.D.”,” ND”, “NMD”, or “N.M.D.” after the name of the individual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual licensed to practice naturopathic medicine in this State may not use the title “physician”.</text> </paragraph> <paragraph num="D."> <text>A naturopathic doctor engaged in the private practice of naturopathic medicine in the state shall:</text> <paragraph num="(1)"> <text>Wear an identification badge tag or badge which identifies that individual as a naturopathic doctor; and</text> </paragraph> <paragraph num="(2)"> <text>Identify himself or herself to all patients as a naturopathic doctor.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual may not identify himself or herself as a naturopathic doctor unless licensed by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Reporting Requirements."> <paragraph num="A."> <text>A licensed naturopathic doctor, a licensed health care practitioner, a health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland, located in the State, and a State agency shall file a written report with the Board if the person has information that gives the person reason to believe that a licensed naturopathic doctor is or may be:</text> <paragraph num="(1)"> <text>Medically or legally incompetent;</text> </paragraph> <paragraph num="(2)"> <text>Engaged in the unauthorized practice of naturopathic medicine;</text> </paragraph> <paragraph num="(3)"> <text>Guilty of unprofessional conduct; or</text> </paragraph> <paragraph num="(4)"> <text>Mentally or physically unable to engage safely in the practice of naturopathic medicine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This report shall be filed within 30 days of an individual or entity becoming aware of this information.</text> </paragraph> <paragraph num="C."> <text>A health care facility shall report promptly to the Board if:</text> <paragraph num="(1)"> <text>A licensed naturopathic doctor voluntarily resigns from the staff of the health care facility, voluntarily limits the licensees staff privileges, or fails to reapply for hospital privileges at the health care facility; and</text> </paragraph> <paragraph num="(2)"> <text>The action of the licensee occurs while the licensee is under formal or informal investigation by the health care facility for possible medical incompetence, unprofessional conduct, or mental or physical impairment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Advertising."> <text>An advertisement may not contain:</text> <paragraph num="A."> <text>A statement containing misrepresentation of facts;</text> </paragraph> <paragraph num="B."> <text>Statements that cannot be verified by the Board for truthfulness;</text> </paragraph> <paragraph num="C."> <text>Statements likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="D."> <text>Statements intended to, or likely to, create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="E."> <text>Statements containing representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or be deceived;</text> </paragraph> <paragraph num="F."> <text>Statements containing representations that a naturopathic doctor is willing to perform any procedure which is illegal under the laws or regulations of this State or the United States;</text> </paragraph> <paragraph num="G."> <text>Statements that are untruthful and improbable or contain, misstatements, falsehoods, misrepresentations, distorted, or fabulous statements as to cures;</text> </paragraph> <paragraph num="H."> <text>Statements that misrepresents the nature, characteristics, or qualities of natural medicines or services provided by a naturopathic doctor pursuant to Health Occupations Article, §14-5F-14(a)(3), (4), (5), (6), or (7), Annotated Code of Maryland;</text> </paragraph> <paragraph num="I."> <text>Statements that a manifestly incurable condition can be permanently cured;</text> </paragraph> <paragraph num="J."> <text>Statements promoting herbal, natural, or dietary supplements as drugs contrary to the laws, rules, and regulations of the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act of 1994;</text> </paragraph> <paragraph num="K."> <text>Advertising that does not comply with state or federal law, including the:</text> <paragraph num="(1)"> <text>Federal Trade Commission Act, Section 12 of 15 U.S.C. §52;</text> </paragraph> <paragraph num="(2)"> <text>Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301—397;</text> </paragraph> <paragraph num="(3)"> <text>Maryland Food, Drug, and Cosmetic Act, Health-General Article, §21-207, et seq., Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Commercial Law Article, §14-2902, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Statements recommending any modality of care that is inconsistent with the health, safety, and welfare of the public; or</text> </paragraph> <paragraph num="M."> <text>Statements made as defined in Health-General Article, §§21-247 and 21-248, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Code of Ethics."> <paragraph num="A."> <text>Naturopathic doctors shall concern themselves primarily with the welfare of the patient.</text> </paragraph> <paragraph num="B."> <text>A naturopathic doctor who suffers from a physical, mental, or emotional impairment, including substance abuse, that impacts the individual’s ability to practice naturopathic medicine shall seek professional treatment and refrain from the practice of naturopathic medicine until the impairment no longer exists or reasonable accommodations can be made.</text> </paragraph> <paragraph num="C."> <text>A naturopathic doctor shall:</text> <paragraph num="(1)"> <text>Use professional discretion and integrity in relationships with a member of the health care community;</text> </paragraph> <paragraph num="(2)"> <text>Be professional in conduct, with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Remain free from conflict of interest while fulfilling the objectives and maintaining the integrity of the naturopathic doctor profession;</text> </paragraph> <paragraph num="(4)"> <text>Provide accurate fee information to the patient, the individual responsible for payment for treatment, and the insurer;</text> </paragraph> <paragraph num="(5)"> <text>At all times respect the patient’s dignity, autonomy, and privacy;</text> </paragraph> <paragraph num="(6)"> <text>Practice naturopathic medicine only as defined in the scope of practice set forth in Health Occupations Article, §14-5F-14(a), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Cooperate with any lawful investigation conducted by the Board, including:</text> <paragraph num="(a)"> <text>Furnishing information requested in a timely manner as directed by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Complying with a subpoena;</text> </paragraph> <paragraph num="(c)"> <text>Responding to a complaint at the request of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Providing meaningful and timely access to relevant patient records; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Report to the Board conduct in the practice of naturopathic medicine that indicates a violation of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 14-5F, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Any other law, including, but not limited to, aiding or abetting the unauthorized practice of naturopathic medicine.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A naturopathic doctor may not:</text> <paragraph num="(1)"> <text>Misrepresent credentials, qualifications, or affiliations and shall attempt to correct others who misrepresent the naturopathic doctor’s credentials, qualifications, or affiliations;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly engage in or condone behavior that is fraudulent, dishonest, or deceitful, or involves moral turpitude;</text> </paragraph> <paragraph num="(3)"> <text>Engage in a commercial activity which conflicts with the duties of a naturopathic doctor;</text> </paragraph> <paragraph num="(4)"> <text>Perform naturopathic medicine on a patient if a contraindication against naturopathic doctor treatment exists;</text> </paragraph> <paragraph num="(5)"> <text>Discriminate against a patient or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability;</text> </paragraph> <paragraph num="(6)"> <text>Intimidate, threaten, influence, or attempt to influence any person regarding any violation of law or regulation; or</text> </paragraph> <paragraph num="(7)"> <text>Aid or abet any individual violating or attempting to violate any provision of law or regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A naturopathic doctor shall:</text> <paragraph num="(1)"> <text>Use professional judgment in the use of evaluation and treatment procedures;</text> </paragraph> <paragraph num="(2)"> <text>Decline to administer treatment if the naturopathic doctor believes that a treatment is contraindicated or unjustified;</text> </paragraph> <paragraph num="(3)"> <text>Terminate a professional relationship with a patient in an appropriate manner, such as:</text> <paragraph num="(a)"> <text>Providing the patient with sufficient notice to permit the patient to obtain the services of another professional;</text> </paragraph> <paragraph num="(b)"> <text>Assisting the patient by providing referrals if appropriate; or</text> </paragraph> <paragraph num="(c)"> <text>Continuing to provide emergency treatment to the patient if treatment is required before a reasonable time has passed to allow the patient to obtain the services of another health care provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Maintain a written record of treatment of the patient under the naturopathic doctor’s care for at least:</text> <paragraph num="(a)"> <text>5 years after the termination of treatment; and</text> </paragraph> <paragraph num="(b)"> <text>5 years after the patient becomes 18 years old, if applicable;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Make the written records of treatment available to the patient upon request, in compliance with applicable laws for disclosure of medical records;</text> </paragraph> <paragraph num="(6)"> <text>Make arrangements for another professional to provide for the needs of the patient during anticipated absences when the naturopathic doctor is unavailable to the patient;</text> </paragraph> <paragraph num="(7)"> <text>Make referrals only to other qualified and duly licensed health care providers;</text> </paragraph> <paragraph num="(8)"> <text>Accurately inform the patient, other health care professionals, and the public of the limitations of the practice of naturopathic medicine;</text> </paragraph> <paragraph num="(9)"> <text>Adequately assess the patient to determine if contraindications against naturopathic medical treatment exist and refer the patient to an appropriate health care practitioner;</text> </paragraph> <paragraph num="(10)"> <text>Exercise independent professional judgment in the treatment or evaluation of the patient regardless of whether the patient was referred by another health care provider;</text> </paragraph> <paragraph num="(11)"> <text>Ensure clear and concise professional communications with patients regarding:</text> <paragraph num="(a)"> <text>Nature and duration of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(c)"> <text>Costs;</text> </paragraph> <paragraph num="(d)"> <text>Billing; and</text> </paragraph> <paragraph num="(e)"> <text>Insurance; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Administer fair and equitable fees to patients regardless of status or insurance.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A naturopathic doctor may not:</text> <paragraph num="(1)"> <text>Accept a client for treatment, or continue unnecessary treatment, when the patient cannot be reasonably expected to benefit from the treatment;</text> </paragraph> <paragraph num="(2)"> <text>Receive remuneration from, or provide remuneration to, or split a fee, for either making or accepting a referral of the patient to or from another health care provider;</text> </paragraph> <paragraph num="(3)"> <text>Make a guarantee or promise about the efficacy of a particular treatment, the naturopathic doctor’s practice, or the result of a treatment unless supported by scientific principles accepted by the profession; or</text> </paragraph> <paragraph num="(4)"> <text>Exploit the professional relationship by:</text> <paragraph num="(a)"> <text>Continuing treatment unnecessarily; or</text> </paragraph> <paragraph num="(b)"> <text>Charging for a service:</text> <paragraph num="(i)"> <text>Not provided; or</text> </paragraph> <paragraph num="(ii)"> <text>Different from those actually provided.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A naturopathic doctor shall:</text> <paragraph num="(1)"> <text>Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship; and</text> </paragraph> <paragraph num="(2)"> <text>Respect and maintain professional boundaries and respect the patient’s reasonable expectation of professional conduct.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A naturopathic doctor may not:</text> <paragraph num="(1)"> <text>Exploit a relationship with a patient, staff member, or student for the naturopathic doctor’s personal advantage including, but not limited to, a personal, sexual, romantic, or financial relationship;</text> </paragraph> <paragraph num="(2)"> <text>Engage in a sexually intimate act with a patient; or</text> </paragraph> <paragraph num="(3)"> <text>Engage in sexual misconduct, which includes, but is not limited to:</text> <paragraph num="(a)"> <text>Therapeutic deception;</text> </paragraph> <paragraph num="(b)"> <text>Non-bona-fide treatment; and</text> </paragraph> <paragraph num="(c)"> <text>A sexually exploitative relationship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A naturopathic doctor may not engage in inappropriate behavior with other practice staff including sexual advances, harassment, discrimination, exploitation, retaliation, and other unprofessional conduct.</text> </paragraph> <paragraph num="J."> <text>A naturopathic doctor shall:</text> <paragraph num="(1)"> <text>Respect and maintain the privacy and confidentiality of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Disclose the patient’s records or information about the patient only with the patient’s consent or as required by law;</text> </paragraph> <paragraph num="(3)"> <text>Adequately safeguard confidential patient information, including storage and disposal of records;</text> </paragraph> <paragraph num="(4)"> <text>Provide sufficient information to a patient to allow the patient to make an informed decision regarding treatment, including:</text> <paragraph num="(a)"> <text>The purpose and nature of an evaluation or treatment regimen;</text> </paragraph> <paragraph num="(b)"> <text>Alternatives to treatment;</text> </paragraph> <paragraph num="(c)"> <text>Side effects and benefits of a treatment regimen proposed and alternatives to that treatment;</text> </paragraph> <paragraph num="(d)"> <text>The estimated cost of treatment and alternatives to treatment;</text> </paragraph> <paragraph num="(e)"> <text>The right of the patient to:</text> <paragraph num="(i)"> <text>Withdraw from treatment at any time, including the risks associated with withdrawing from treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program; or</text> </paragraph> <paragraph num="(iii)"> <text>Terminate any treatment contract at any time, for any or no reason, with no fee or penalty incurred;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Obtain the full informed consent of a patient participating in a human research program, without communicating a direct or implied penalty for the patient’s refusal to participate in the program and with due regard for the patient’s autonomy and dignity;</text> </paragraph> <paragraph num="(6)"> <text>Comply with applicable federal and state laws for human research programs; and</text> </paragraph> <paragraph num="(7)"> <text>Promptly and efficiently respond to any patient or Board request for records.</text> </paragraph> </paragraph> <paragraph num="K."> <text>A naturopathic doctor shall:</text> <paragraph num="(1)"> <text>Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and</text> </paragraph> <paragraph num="(2)"> <text>Be current in the qualifications to practice, including meeting continuing education requirements as set forth in Regulation 11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The naturopathic doctor may not perform a treatment or provide a service that the naturopathic doctor is not qualified to perform or which is beyond the scope of the naturopathic doctor’s education, training, capabilities, experience, and scope of practice.</text> </paragraph> <paragraph num="M."> <text>A naturopathic doctor may not construe any failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and generally recognized in the naturopathic medicine profession.</text> </paragraph> <paragraph num="N."> <text>A violation in this chapter may result in the Board taking action pursuant to Health Occupations Article, §14-5F-18, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Fees."> <text>The following fees are applicable to naturopathic doctors:</text> <paragraph num="A."> <text>Initial application fee — $790;</text> </paragraph> <paragraph num="B."> <text>Renewal Fee:</text> <paragraph num="(1)"> <text>Biennial license renewal fee — $486; and</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Health Care Commission fee as determined by Maryland Health Care Commission under COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="C."> <text>License reinstatement fee—$700; and</text> </paragraph> <paragraph num="D."> <text>Written verification fee—$50.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Initial Licensure by Reciprocity."> <paragraph num="A."> <text>Requirements. An applicant for initial licensure by reciprocity shall:</text> <paragraph num="(1)"> <text>Have an active, unrestricted license to practice naturopathic medicine in another jurisdiction that, at the time the applicant was licensed, had licensure requirements that were equivalent to or exceeded those set forth in Regulation .04A;</text> </paragraph> <paragraph num="(2)"> <text>Be in good standing under the laws of every jurisdiction where the individual is licensed; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Documentation. An applicant for initial licensure by reciprocity shall submit to the Board:</text> <paragraph num="(1)"> <text>An application for reciprocity on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The application fee as set by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Evidence of compliance with §A of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>A written attestation as provided in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Any additional documentation set forth in Regulation .06 of this chapter that is needed for the Board to evaluate an application;</text> </paragraph> <paragraph num="(6)"> <text>Any evidence relating to any disciplinary action taken or any administrative penalties assessed against the applicant by the appropriate state licensing, certification, or registration authority; and</text> </paragraph> <paragraph num="(7)"> <text>Any consent agreements into which the applicant entered that contain conditions placed on the applicant’s professional conduct and practice, including any voluntary surrender of a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not issue a license if the criminal history records information, pursuant to §A of this regulation, has not been received and reviewed.</text> </paragraph> <paragraph num="D."> <text>After a license is issued, the licensee is subject to the Board’s jurisdiction and shall comply with all laws and regulations governing the practice of naturopathic medicine in the State.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-5F-12.1—14-5F-32, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 12, 2016 (43:18 Md. R. 1017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 28, 2017 (44:17 Md. R. 835); January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C, D amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D, E adopted effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed and new Regulation .10 adopted effective August 28, 2017 (44:17 Md. R. 835); January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective August 28, 2017 (44:17 Md. R. 835)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective January 19, 2026 (53:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 adopted effective August 28, 2017 (44:17 Md. R. 835)</annotation> </annotations> </chapter> <chapter num="22" heading="Mandated Reporting to the Board"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs reporting requirements to the Board of Physicians concerning health care providers and naturopathic doctors by:</text> <paragraph num="A."> <text>Hospitals;</text> </paragraph> <paragraph num="B."> <text>Related institutions;</text> </paragraph> <paragraph num="C."> <text>Employers of allied health providers or naturopathic doctors;</text> </paragraph> <paragraph num="D."> <text>Health care facilities;</text> </paragraph> <paragraph num="E."> <text>State agencies;</text> </paragraph> <paragraph num="F."> <text>Health care practitioners;</text> </paragraph> <paragraph num="G."> <text>Naturopathic doctors; and</text> </paragraph> <paragraph num="H."> <text>Alternative health systems.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abandon” means a health care provider’s withdrawal from the care and treatment of a patient during the course of treatment without giving reasonable notice to the patient or providing a competent replacement.</text> </paragraph> <paragraph num="(2)"> <text>“Acts” means Health Occupations Article, Title 14, including subtitles 5A, 5B, 5C, 5E, and 5F, and Title 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative suspension” means an action imposed by a reporting entity restricting a health care provider’s privileges or hours or scope of employment for failure of the health care provider to comply with the bylaws, rules, policies, or procedures of the reporting entity.</text> </paragraph> <paragraph num="(4)"> <text>“Allied health provider” means an individual who is licensed by the Board under Health Occupations Article, Title 14, Subtitles 5A, 5B, 5C, or 5E, or Title 15, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Alternative health system” has the same meaning as alternative health care system as defined in Health Occupations Article, §1-401(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(7)"> <text>“Change” means any of the following actions by a reporting entity:</text> <paragraph num="(a)"> <text>Terminating or failing to renew a health care provider’s staff privileges or employment or contract with the reporting entity;</text> </paragraph> <paragraph num="(b)"> <text>Taking disciplinary action against a health care provider who continues to be employed, enjoy privileges, or contract with the reporting entity, including but not limited to:</text> <paragraph num="(i)"> <text>Suspension;</text> </paragraph> <paragraph num="(ii)"> <text>Placement on probation; or</text> </paragraph> <paragraph num="(iii)"> <text>Restriction or limitation of privileges or duties;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Accepting an involuntary resignation as defined in this regulation;</text> </paragraph> <paragraph num="(d)"> <text>Accepting or acquiescing to an involuntary leave of absence as defined in this regulation;</text> </paragraph> <paragraph num="(e)"> <text>Accepting or acquiescing to an involuntary alteration in practice as defined in this regulation;</text> </paragraph> <paragraph num="(f)"> <text>Requesting that a health care staffing entity cease furnishing the services of a particular health care provider;</text> </paragraph> <paragraph num="(g)"> <text>In the case of a physician, denying:</text> <paragraph num="(i)"> <text>By a hospital or related institution, an application for staff privileges; or</text> </paragraph> <paragraph num="(ii)"> <text>By an alternative health care system, an application for employment; or</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Terminating the delegation agreement of a physician assistant.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Failure to report” means the failure of a reporting entity to file a report with the Board as mandated by this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Focused professional practice evaluation (FPPE)” means any process used by a reporting entity to assess the competence or proficiency of a health care provider in a certain clinical skill, activity, or procedure.</text> </paragraph> <paragraph num="(10)"> <text>“Focused review” has the same meaning as “focused professional practice evaluation” as defined in this regulation.</text> </paragraph> <paragraph num="(11)"> <text>“Good standing” means the health care provider is not suspended, on probation, or subject to any pending disciplinary proceedings, an involuntary alteration in practice, or an involuntary leave of absence, as these terms are defined in this regulation.</text> </paragraph> <paragraph num="(12)"> <text>“Health care facility” has the meaning stated in Health-General Article, §19-114, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Health care provider” means a physician or an allied health provider.</text> </paragraph> <paragraph num="(14)"> <text>“Health care staffing entity” means a business entity that contracts to provide, directly or indirectly, the personal health care services of one or more health care providers to a reporting entity.</text> </paragraph> <paragraph num="(15)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(16)"> <text>“Involuntary alteration in practice” means a modification in the privileges, employment, or contractual duties of a health care provider, whether self-initiated by the health care provider, mutually agreed upon, or requested or suggested by the reporting entity:</text> <paragraph num="(a)"> <text>After the health care provider has been notified of pending discharge or termination of privileges or a contract, or pending proceedings possibly leading to discharge or termination of privileges or a contract;</text> </paragraph> <paragraph num="(b)"> <text>While the health care provider is under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE;</text> </paragraph> <paragraph num="(c)"> <text>After the health care provider has been notified that an investigation or inquiry may begin; or</text> </paragraph> <paragraph num="(d)"> <text>After the health care provider has been asked to respond to a complaint made to the reporting entity.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Involuntary leave of absence” means a hiatus, however designated, during which a health care provider does not exercise staff privileges or fulfill the duties of employment or a contract, whether the hiatus was self-initiated, mutually agreed upon, or requested or imposed by the reporting entity, where the health care provider commenced the hiatus:</text> <paragraph num="(a)"> <text>After being notified of pending discharge or termination of privileges or a contract, or pending proceedings possibly leading to discharge or termination of privileges or a contract;</text> </paragraph> <paragraph num="(b)"> <text>While under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE;</text> </paragraph> <paragraph num="(c)"> <text>After being notified that an investigation or inquiry may begin; or</text> </paragraph> <paragraph num="(d)"> <text>After being asked to respond to a complaint made to the reporting entity.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Involuntary resignation” means a health care provider’s relinquishment of privileges, employment, or a contract with a reporting entity, whether the relinquishment was self-initiated, mutually agreed upon, or had been requested by the reporting entity, and however designated by the health care provider or the reporting entity, if the health care provider resigned:</text> <paragraph num="(a)"> <text>After being notified that discharge or termination of privileges, employment, or a contract, or that proceedings possibly leading to discharge or termination of privileges, employment, or a contract, would occur if the health care provider would not resign;</text> </paragraph> <paragraph num="(b)"> <text>While under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE;</text> </paragraph> <paragraph num="(c)"> <text>After being notified that an investigation or inquiry may begin; or</text> </paragraph> <paragraph num="(d)"> <text>After being asked to respond to a complaint made to the reporting entity.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Licensed physician” means an individual, including doctor of osteopathy, who is licensed by the Board to practice medicine.</text> </paragraph> <paragraph num="(20)"> <text>“Mandated report” means any report required under the Acts or this chapter.</text> </paragraph> <paragraph num="(21)"> <text>“Naturopathic doctor” means an individual who is licensed by the Board under Health Occupations Article, Title14, Subtitle 5F, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Privileges” means authorization granted by a reporting entity to a health care provider to provide specific care, treatment, diagnostic services, or other services to patients.</text> </paragraph> <paragraph num="(23)"> <text>“Related institution” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Reporting entity” means:</text> <paragraph num="(a)"> <text>A hospital, a related institution, or an alternative health system, as these terms are defined in this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>An employer of an allied health provider that is not a hospital, a related institution, or an alternative health system.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Voluntary alteration in practice” means a modification in the privileges, employment, or contractual duties made with respect to a health care provider in good standing that is not an involuntary alteration in practice as defined in this regulation.</text> </paragraph> <paragraph num="(26)"> <text>“Voluntary leave of absence” means a hiatus from providing health care services taken by a health care provider in good standing that is not an involuntary leave of absence as defined in this regulation.</text> </paragraph> <paragraph num="(27)"> <text>“Voluntary resignation” means the relinquishment of privileges, employment, or a contract with a reporting entity taken by a health care provider in good standing that is not an involuntary resignation as defined in this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Mandated Reports."> <paragraph num="A."> <text>Subject to the limitations set out in §§B, C and D of this regulation, the reporting entity shall report to the Board in writing any change made with respect to a health care provider:</text> <paragraph num="(1)"> <text>Whom the reporting entity employs;</text> </paragraph> <paragraph num="(2)"> <text>Who works with the reporting entity under contract; or</text> </paragraph> <paragraph num="(3)"> <text>To whom the reporting entity has granted privileges.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A reporting entity shall inform the Board of any change that has been made, in whole or in part, because the reporting entity had reason to believe that the health care provider:</text> <paragraph num="(1)"> <text>Abandoned a patient;</text> </paragraph> <paragraph num="(2)"> <text>Provided patient care of questionable quality;</text> </paragraph> <paragraph num="(3)"> <text>Disrupted the workplace;</text> </paragraph> <paragraph num="(4)"> <text>Committed unethical or unprofessional conduct;</text> </paragraph> <paragraph num="(5)"> <text>Committed billing or coding fraud;</text> </paragraph> <paragraph num="(6)"> <text>Used the reporting entity’s employment or privileges to commit illegal or unethical business practices;</text> </paragraph> <paragraph num="(7)"> <text>Suffers from a physical, a mental, or an emotional condition or impairment that affects the health care provider’s ability to perform the individual’s medical or surgical duties;</text> </paragraph> <paragraph num="(8)"> <text>Is habitually intoxicated by alcohol or a controlled dangerous substance;</text> </paragraph> <paragraph num="(9)"> <text>Provided care while under the influence of alcohol or while abusing or misusing any controlled dangerous substance or mood-altering substance;</text> </paragraph> <paragraph num="(10)"> <text>Has not complied with the requirements of an alcohol or a drug treatment program;</text> </paragraph> <paragraph num="(11)"> <text>With respect to allied health providers, failed to notify the reporting entity of the health care provider’s decision to enter into an alcohol or a drug treatment program;</text> </paragraph> <paragraph num="(12)"> <text>Performed care beyond the scope of licensure or privileges or delegated duties, or delegated duties to an individual not authorized to perform those duties;</text> </paragraph> <paragraph num="(13)"> <text>Repeatedly failed to complete medical records;</text> </paragraph> <paragraph num="(14)"> <text>Repeatedly violated hospital bylaws, rules, policies, or procedures after warning; or</text> </paragraph> <paragraph num="(15)"> <text>Committed any other act or suffered from any other condition which the reporting entity had reason to believe may constitute a violation of the Acts.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific Changes Not Reportable. The following changes do not require reporting by a reporting entity:</text> <paragraph num="(1)"> <text>Voluntary leaves of absence that:</text> <paragraph num="(a)"> <text>Are not involuntary leaves of absence as defined in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Are taken by a health care provider who is in good standing; and</text> </paragraph> <paragraph num="(c)"> <text>May be caused by, for example:</text> <paragraph num="(i)"> <text>Maternity leave;</text> </paragraph> <paragraph num="(ii)"> <text>Family problems of a medical or other personal nature;</text> </paragraph> <paragraph num="(iii)"> <text>Medical problems that do not implicate the health care provider’s physical, mental, or emotional ability to provide competent care;</text> </paragraph> <paragraph num="(iv)"> <text>Military deployment;</text> </paragraph> <paragraph num="(v)"> <text>Sabbaticals;</text> </paragraph> <paragraph num="(vi)"> <text>Extended vacations; or</text> </paragraph> <paragraph num="(vii)"> <text>Absences for professional training;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Voluntary resignations that:</text> <paragraph num="(a)"> <text>Are not involuntary resignations as defined in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Are submitted by a health care provider who is in good standing; and</text> </paragraph> <paragraph num="(c)"> <text>May be caused by, for example:</text> <paragraph num="(i)"> <text>A job or career change;</text> </paragraph> <paragraph num="(ii)"> <text>The health care provider’s desire to relocate from Maryland; or</text> </paragraph> <paragraph num="(iii)"> <text>The health care provider’s desire to retire;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Voluntary alterations in practice that:</text> <paragraph num="(a)"> <text>Are not involuntary alterations in practice as defined in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Are submitted by a health care provider who is in good standing; and</text> </paragraph> <paragraph num="(c)"> <text>May be caused by, for example, a health care provider’s desire to:</text> <paragraph num="(i)"> <text>Switch from active practice to consulting;</text> </paragraph> <paragraph num="(ii)"> <text>Reduce workload; or</text> </paragraph> <paragraph num="(iii)"> <text>Alter a specialty or scope of practice;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>With respect to allied health providers, the initial denial of employment or privileges;</text> </paragraph> <paragraph num="(5)"> <text>With respect to physicians, an involuntary alteration in practice that:</text> <paragraph num="(a)"> <text>Results solely from an FPPE or a focused review;</text> </paragraph> <paragraph num="(b)"> <text>Does not by itself or in combination with any other involuntary alteration in practice exceed 90 days in any one calendar year;</text> </paragraph> <paragraph num="(c)"> <text>Consists solely of one or more of the following:</text> <paragraph num="(i)"> <text>A program of additional training or monitoring or heightened scrutiny of the individual’s practice; or</text> </paragraph> <paragraph num="(ii)"> <text>A requirement that the individual successfully perform a skill, an activity, or a procedure a specific number of times, or within a specific time period; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Does not result from inappropriate sexual behavior, harassment, or any other unprofessional conduct in the workplace;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>With respect to physicians, the initial denial of employment or privileges due solely to the applicant’s:</text> <paragraph num="(a)"> <text>Inability to fulfill on-call requirements because of other time commitments;</text> </paragraph> <paragraph num="(b)"> <text>Lack of a board certification required by the reporting entity; or</text> </paragraph> <paragraph num="(c)"> <text>Lack of experience in conducting a particular medical procedure;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Administrative suspensions, if the sum total does not cumulatively exceed 30 days in any one calendar year, imposed on or agreed to by the health care provider, solely for the health care provider’s failure to:</text> <paragraph num="(a)"> <text>Acquire mandated vaccinations or required serum titers for infections;</text> </paragraph> <paragraph num="(b)"> <text>Attend required meetings;</text> </paragraph> <paragraph num="(c)"> <text>Complete medical records;</text> </paragraph> <paragraph num="(d)"> <text>Complete required training; or</text> </paragraph> <paragraph num="(e)"> <text>Maintain or submit a certificate of professional insurance;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>With respect to allied health providers and subject to the requirements of §D(1) and (2) of this regulation, entrance into an alcohol or a drug treatment program:</text> <paragraph num="(a)"> <text>That is accredited by the Joint Commission;</text> </paragraph> <paragraph num="(b)"> <text>That is certified by the Maryland Department of Health;</text> </paragraph> <paragraph num="(c)"> <text>To which the allied health provider is referred by the Maryland Physician Health Program or the Maryland Healthcare Professionals Program; or</text> </paragraph> <paragraph num="(d)"> <text>Provided by a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse; or</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>With respect to physicians and subject to the requirements of §D(3) and (4) of this regulation, entrance into an alcohol or a drug treatment program:</text> <paragraph num="(a)"> <text>That is accredited by the Joint Commission;</text> </paragraph> <paragraph num="(b)"> <text>That is certified by the Maryland Department of Health; or</text> </paragraph> <paragraph num="(c)"> <text>To which the physician is referred by the Maryland Physician Health Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions to §C(8) and (9) of This Regulation.</text> <paragraph num="(1)"> <text>Section C(8) of this regulation applies only where:</text> <paragraph num="(a)"> <text>The allied health provider notified the reporting entity at the time the allied health provider decided to enter the program;</text> </paragraph> <paragraph num="(b)"> <text>The reporting entity is able to verify that the allied health provider remains continually in the program until properly discharged; and</text> </paragraph> <paragraph num="(c)"> <text>The action or condition of the allied health provider had not caused injury to any individual during the provision of health care by the allied health provider.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Section C(8) of this regulation does not apply to:</text> <paragraph num="(a)"> <text>Any change made by a reporting entity relating to the discharge of an allied health provider from an alcohol or a drug treatment program, when that discharge was for non-attendance or non-compliance with the program;</text> </paragraph> <paragraph num="(b)"> <text>Additional changes made by the reporting entity, other than minor scheduling changes made solely to accommodate participation in the program; or</text> </paragraph> <paragraph num="(c)"> <text>Any change made by the reporting entity based on events set out in Regulation .03B which occurred subsequent to the provider’s entrance into the alcohol or drug treatment program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Section C(9) of this regulation applies only where:</text> <paragraph num="(a)"> <text>The physician notified the reporting entity at the time the physician decided to enter the program;</text> </paragraph> <paragraph num="(b)"> <text>The reporting entity is able to verify that the physician remains continually in the program until properly discharged; and</text> </paragraph> <paragraph num="(c)"> <text>The action or condition of the physician had not resulted in injury to any individual during the provision of health care by the physician.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Section C(9) of this regulation does not apply to:</text> <paragraph num="(a)"> <text>Any change made by a reporting entity relating to the discharge of a physician by an alcohol or a drug treatment program, when that discharge was for non-attendance or non-compliance with the program;</text> </paragraph> <paragraph num="(b)"> <text>Additional changes made by the reporting entity, other than minor scheduling changes made solely to accommodate participation in the program; or</text> </paragraph> <paragraph num="(c)"> <text>Any change made by the reporting entity relating to events set out in §B of this regulation which occurred subsequent to the physician’s entrance into the alcohol or drug treatment program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Naturopathic Doctors."> <paragraph num="A."> <text>A licensed naturopathic doctor, other licensed health care practitioner, health care facility located in the State, or State agency shall file a written report to the Board if there is reason to believe that a licensed naturopathic doctor is or may be:</text> <paragraph num="(1)"> <text>Medically or legally incompetent;</text> </paragraph> <paragraph num="(2)"> <text>Engaged in the unauthorized practice of naturopathic medicine;</text> </paragraph> <paragraph num="(3)"> <text>Guilty of unprofessional conduct; or</text> </paragraph> <paragraph num="(4)"> <text>Mentally or physically unable to engage safely in the practice of naturopathic medicine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The report required under §A of this regulation shall be filed with the Board within 30 days after the individual or entity becomes aware of this information.</text> </paragraph> <paragraph num="C."> <text>A health care facility shall report within 10 days to the Board if a licensed naturopathic doctor voluntarily resigns from the staff of the health care facility, voluntarily limits staff privileges, or fails to reapply for hospital privileges at the health care facility while the naturopathic doctor is under formal or informal investigation by the health care facility for possible medical incompetence, unprofessional conduct, or mental or physical impairment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Time Frames for the Submission of Reports."> <paragraph num="A."> <text>Physicians.</text> <paragraph num="(1)"> <text>A reporting entity shall file reports required under this chapter with the Board within 10 days of any change made with regard to a physician.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 days, the reporting entity who has reported a change to the Board under this chapter shall report to the Board in writing any modifications made to, or subsequent developments in, that change.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Allied Health Providers.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) of this regulation, a reporting entity shall file any report required under this chapter within 10 days of any change made with respect to allied health providers.</text> </paragraph> <paragraph num="(2)"> <text>With respect to physician assistants:</text> <paragraph num="(a)"> <text>An employer of a physician assistant who terminates the physician assistant because of a quality of care issue shall report the termination within 5 days of the termination;</text> </paragraph> <paragraph num="(b)"> <text>A physician or an employer who terminates a delegation agreement with a physician assistant shall report that termination within 10 days; and</text> </paragraph> <paragraph num="(c)"> <text>A report submitted under §B(2)(b) of this regulation may not be used to fulfill the requirement of §B(2)(a) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Naturopathic Doctors.</text> <paragraph num="(1)"> <text>Within 30 days, a licensed naturopathic doctor, other licensed health care provider, health care facility located in the State, or State agency shall file a written report with the Board upon becoming aware of information described in Regulation .04A of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 days, a health care facility shall report to the Board any information required under Regulation .04C of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Enforcement."> <paragraph num="A."> <text>The Board shall conduct any necessary investigation regarding failure of a reporting entity to file a report required under this chapter.</text> </paragraph> <paragraph num="B."> <text>Over the signature of an officer, the executive director, or the deputy director, the Board may issue subpoenas in connection with any investigation or proceeding to enforce this chapter.</text> </paragraph> <paragraph num="C."> <text>Before submission of the final investigative report to the Board, the investigator shall inform the reporting entity of the allegation of failure to report and offer the reporting entity an opportunity to submit a written response. Any written response shall be made part of the investigative report. The investigative report is confidential and may not be released to any person except as provided in §E of this regulation.</text> </paragraph> <paragraph num="D."> <text>The final investigative report shall be submitted to the Board. The Board, after consideration of the investigative report, shall:</text> <paragraph num="(1)"> <text>If it finds probable cause that the reporting entity failed to report as required by this chapter, vote to issue a notice of failure to file a report setting out the facts of the alleged failure and the recommended civil penalty as set out in §O of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Dismiss the case.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Board votes to issue a notice of failure to file a report, the Board shall mail by first class mail the notice of failure to file a report to the reporting entity involved. Upon this mailing, the Board shall make available to the reporting entity the investigative report, less the names of any confidential informants who will not be called as witnesses in the case.</text> </paragraph> <paragraph num="F."> <text>If the reporting entity does not request a hearing within 30 days of the date the notice of failure to file a report was mailed, the notice of failure to file a report shall become final and shall constitute a final disposition of the Board.</text> </paragraph> <paragraph num="G."> <text>A reporting entity which has timely filed a request for a hearing may choose to attend a settlement conference with a committee of the Board to attempt to resolve a case. If a settlement conference is convened:</text> <paragraph num="(1)"> <text>The reporting entity may be represented by counsel;</text> </paragraph> <paragraph num="(2)"> <text>Except for consideration of a proposed resolution of the case, the Board may not use any commentary, admissions, facts revealed, or positions taken at the settlement conference, unless the subject matter is available from other sources or is otherwise discovered;</text> </paragraph> <paragraph num="(3)"> <text>At the conclusion of the settlement conference, the committee shall recommend either:</text> <paragraph num="(a)"> <text>Dismissing the notice of failure to file a report; or</text> </paragraph> <paragraph num="(b)"> <text>Upholding the notice of failure to file a report and imposing a civil penalty as set out in §O of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>If the reporting entity agrees with the recommendation of the settlement committee, the Board shall consider the recommendation and either accept or reject it. The Board’s acceptance of the settlement committee’s recommendation constitutes the Board’s final disposition of the case.</text> </paragraph> <paragraph num="I."> <text>If a settlement is not reached or if the settlement committee’s recommendation is not approved by the Board, the case shall proceed to a hearing before the Board.</text> </paragraph> <paragraph num="J."> <text>The hearing ordinarily shall be limited to oral argument before the Board. The issues at the hearing are limited to whether a reporting entity:</text> <paragraph num="(1)"> <text>Made a change as defined in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Had reason to believe that the change was made, in whole or in part, because of a reason listed in Regulation .03B of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Reported the change to the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Reported the change within the time frames set out in this chapter.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Board chair or alternate presiding officer may reasonably limit the time for oral argument.</text> </paragraph> <paragraph num="L."> <text>The Board shall conduct an evidentiary hearing if the chair or alternate presiding officer finds that there is a substantial dispute concerning one or more of the material facts set out in §J of this regulation. If there is an evidentiary hearing, the Board chair or alternate presiding officer may:</text> <paragraph num="(1)"> <text>Administer oaths or affirmations;</text> </paragraph> <paragraph num="(2)"> <text>Issue subpoenas for relevant evidence;</text> </paragraph> <paragraph num="(3)"> <text>Make all rulings on the admission of evidence;</text> </paragraph> <paragraph num="(4)"> <text>Rule on motions;</text> </paragraph> <paragraph num="(5)"> <text>Exclude repetitive or irrelevant evidence, require the parties to narrow the factual evidence to the relevant issues, and make any other rulings in order to focus and expedite the proceeding;</text> </paragraph> <paragraph num="(6)"> <text>Require proffers of evidence in advance of the hearing and make evidentiary rulings before the commencement of the hearing; and</text> </paragraph> <paragraph num="(7)"> <text>Reasonably limit the time for presentations.</text> </paragraph> </paragraph> <paragraph num="M."> <text>It is not a defense to the allegation of a failure to report that:</text> <paragraph num="(1)"> <text>An employee of the reporting entity was not aware of:</text> <paragraph num="(a)"> <text>The change made by the reporting entity; or</text> </paragraph> <paragraph num="(b)"> <text>The obligation to report; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The reporting entity was conducting its own proceeding to further evaluate the change or the reasons for the change.</text> </paragraph> </paragraph> <paragraph num="N."> <text>If the Board finds after the hearing that the reporting entity did not fail to file any report required by this chapter, the Board shall issue a final disposition dismissing the notice of failure to file a report.</text> </paragraph> <paragraph num="O."> <text>If the Board finds after a hearing that a reporting entity failed to file any report required by this chapter, the Board shall issue a final disposition with findings of fact, conclusions of law, and civil penalty. In its final disposition, the Board may impose a civil penalty as follows:</text> <paragraph num="(1)"> <text>With respect to reports concerning physicians:</text> <paragraph num="(a)"> <text>$2,500 for the first occurrence in a calendar year; or</text> </paragraph> <paragraph num="(b)"> <text>$5,000 for any subsequent occurrence in a calendar year; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>With respect to reports concerning allied health providers:</text> <paragraph num="(a)"> <text>$500 for the first occurrence in a calendar year; or</text> </paragraph> <paragraph num="(b)"> <text>$1,000 for any subsequent occurrence in a calendar year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="P."> <text>The Board disposition is the final administrative action on the matter.</text> </paragraph> <paragraph num="Q."> <text>A reporting entity that is dissatisfied with a final disposition of the Board may seek judicial review of the Board’s final disposition as provided in the Administrative Procedure Act. The disposition of the Board may not be stayed pending judicial review.</text> </paragraph> <paragraph num="R."> <text>The Board shall pay all monies collected pursuant to this chapter into the State’s General Fund. The Board may refer any uncollected civil penalties under this regulation to the Central Collection Unit of the State.</text> </paragraph> <paragraph num="S."> <text>The investigative and quasi-judicial procedures set out in this regulation, and the confidentiality provisions of Regulation .07 of this chapter, apply to licensed naturopathic doctors, other licensed health care providers, health care facilities located in the State, and State agencies with respect to any allegations that they failed to file a report required under Regulation .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality."> <text>A report made to the Board under this chapter is not subject to subpoena or discovery in any civil action other than a proceeding arising out of a hearing and the final disposition of the Board or disciplinary panel.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Public Notice of Failure to File a Report and Disposition."> <paragraph num="A."> <text>The notice of failure to file a report and any final disposition under this chapter are public documents.</text> </paragraph> <paragraph num="B."> <text>The notice of failure to file a report and any final disposition shall redact:</text> <paragraph num="(1)"> <text>The name of a patient and any other patient-identifying information; and</text> </paragraph> <paragraph num="(2)"> <text>Records of a health care provider’s or a naturopathic doctor’s physical, mental, or emotional condition, except to the extent necessary to identify the deficient practice or condition that caused an entity to make a change as defined in Regulation .02 of this chapter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§14-205(a)(2), 14-413, 14-414, 14-5A-18, 14-5B-15, 14-5C-18,14-5E-18, 14-5F-19, and 15-103, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1215)</annotation> </annotations> </chapter> <chapter num="23" heading="Permits for the Dispensing of Prescription Drugs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines the parameters under which a physician may obtain a permit to dispense prescription drugs to that physician’s patients, dispense prescription drugs to the patients of other prescribers under certain circumstances, and delegate parts of the dispensing process to others in accordance with Health Occupations Article, §§12-102 and 14-306, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(2)"> <text>“Controlled dangerous substance (CDS)” has the meaning stated in Criminal Law Article, §5-101(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Drug sample” has the meaning stated in 21 CFR §203.3(i).</text> </paragraph> <paragraph num="(5)"> <text>Final Check.</text> <paragraph num="(a)"> <text>“Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient.</text> </paragraph> <paragraph num="(b)"> <text>“Final check” includes the assumption of responsibility for the filled prescription, including verifying the:</text> <paragraph num="(i)"> <text>Appropriateness of the dose;</text> </paragraph> <paragraph num="(ii)"> <text>Accurate expiration date;</text> </paragraph> <paragraph num="(iii)"> <text>Accuracy of the drug dispensed;</text> </paragraph> <paragraph num="(iv)"> <text>Strength of the drug dispensed;</text> </paragraph> <paragraph num="(v)"> <text>Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(vi)"> <text>Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“In good standing” means that an individual:</text> <paragraph num="(a)"> <text>Holds a license to practice medicine in this State;</text> </paragraph> <paragraph num="(b)"> <text>Is not currently suspended by any order imposed by any medical licensing board;</text> </paragraph> <paragraph num="(c)"> <text>Is not currently on probation by any order imposed by any medical licensing board;</text> </paragraph> <paragraph num="(d)"> <text>Is not currently subject to any restrictions on practice related to the abuse, misuse, or improper prescribing of drugs;</text> </paragraph> <paragraph num="(e)"> <text>Has not been within the past 5 years sanctioned by any medical licensing board for the commission of a crime of moral turpitude or for a violation of Health Occupations Article, §14-404(a)(7), (8), (9), (10), or (28), Annotated Code of Maryland, or a similar statute of another state; and</text> </paragraph> <paragraph num="(f)"> <text>Has not within the past 5 years had the CDS registration issued by the OCSA or its predecessor, the registration issued by the federal Drug Enforcement Agency, or the Board dispensing permit:</text> <paragraph num="(i)"> <text>Revoked;</text> </paragraph> <paragraph num="(ii)"> <text>Suspended; or</text> </paragraph> <paragraph num="(iii)"> <text>Voluntarily relinquished or surrendered while under investigation or after being informed that an investigation will be commenced.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“In the public interest” means that a pharmacy is not conveniently available to the patient.</text> </paragraph> <paragraph num="(8)"> <text>Mechanical Act.</text> <paragraph num="(a)"> <text>“Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion.</text> </paragraph> <paragraph num="(b)"> <text>“Mechanical act” does not include:</text> <paragraph num="(i)"> <text>Selecting a drug;</text> </paragraph> <paragraph num="(ii)"> <text>Labeling;</text> </paragraph> <paragraph num="(iii)"> <text>Measuring or calculating dosages;</text> </paragraph> <paragraph num="(iv)"> <text>Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug;</text> </paragraph> <paragraph num="(v)"> <text>Substituting one dosage form of a drug for another;</text> </paragraph> <paragraph num="(vi)"> <text>Altering the route of administration; or</text> </paragraph> <paragraph num="(vii)"> <text>Counseling patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“OCSA” means the Office of Controlled Substances Administration of the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Permit holder” means a physician licensed in this State who holds a valid dispensing permit under this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Readily retrievable” means maintained by any method by which the permit holder can retrieve and produce the record to OCSA during the course of an unscheduled on-site inspection.</text> </paragraph> <paragraph num="(12)"> <text>“Sample unit” has the meaning stated in 21 CFR §203.3 (aa).</text> </paragraph> <paragraph num="(13)"> <text>“Supplier” means:</text> <paragraph num="(a)"> <text>A wholesale distributor as defined in Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A pharmacy, to the extent permitted by Health Occupations Article, §12-406(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permit Not Required."> <text>A dispensing permit is not required to:</text> <paragraph num="A."> <text>Dispense prescription drugs or devices at a health facility or center described in Health Occupations Article, §12-102(g)(1)—(3), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>Dispense to a patient, free of charge:</text> <paragraph num="(1)"> <text>A drug sample;</text> </paragraph> <paragraph num="(2)"> <text>A sample unit; or</text> </paragraph> <paragraph num="(3)"> <text>A starter dosage of a prescription drug, not to exceed a 72-hour supply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Dispensing Permits."> <paragraph num="A."> <text>An applicant for a dispensing permit shall:</text> <paragraph num="(1)"> <text>Possess a license to practice medicine in this State;</text> </paragraph> <paragraph num="(2)"> <text>Be in good standing as that term is defined in this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(4)"> <text>Demonstrate a basic knowledge of the statutes and regulations governing the practice of dispensing prescription drugs;</text> </paragraph> <paragraph num="(5)"> <text>Complete the application on a form supplied by the Board; and</text> </paragraph> <paragraph num="(6)"> <text>Pay the required fee as set out in COMAR 10.32.01.12.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>State each location at which prescription drugs will be dispensed; and</text> </paragraph> <paragraph num="(2)"> <text>Grant permission to OCSA to inspect each location at which drugs will be dispensed at any reasonable hour.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for renewal of a dispensing permit shall submit, upon request, documentation of completion of at least ten continuing education credits related to the preparing and dispensing of prescription drugs offered by the Accreditation Council for Pharmacy Education or as approved by the Secretary of the Maryland Department of Health.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Consideration of Applications."> <text>The Board shall grant the application for a dispensing permit if:</text> <paragraph num="A."> <text>The applicant meets the requirements of Regulation .04 of this chapter;</text> </paragraph> <paragraph num="B."> <text>The applicant has not been sanctioned by the Board for dispensing drugs without a permit within the last 5 years; and</text> </paragraph> <paragraph num="C."> <text>Granting the application is in the public interest.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Requirements for Permit Holders."> <paragraph num="A."> <text>A permit holder shall comply with all federal and State statutes and regulations regarding prescription drugs, including all requirements for:</text> <paragraph num="(1)"> <text>Dispensing, including labeling;</text> </paragraph> <paragraph num="(2)"> <text>Storing and securing inventory;</text> </paragraph> <paragraph num="(3)"> <text>Allowing access only to authorized individuals;</text> </paragraph> <paragraph num="(4)"> <text>Managing inventory controls;</text> </paragraph> <paragraph num="(5)"> <text>Recordkeeping; and</text> </paragraph> <paragraph num="(6)"> <text>Submitting prescription monitoring data to the Maryland Prescription Drug Monitoring Program in accordance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A permit holder shall:</text> <paragraph num="(1)"> <text>Perform in person the final check of each drug dispensed;</text> </paragraph> <paragraph num="(2)"> <text>Sign or initial documentation in person that the final check was completed;</text> </paragraph> <paragraph num="(3)"> <text>Be present on the premises and available for consultation at the time the drug is dispensed;</text> </paragraph> <paragraph num="(4)"> <text>With regard to inspections by the OCSA:</text> <paragraph num="(a)"> <text>Personally sign at the time of the inspection the acknowledgement of receipt of the inspection report required by Health Occupations Article, §12-102(c)(2)(ii)4D, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Assure that during all normal office hours a designee is available on the premises who will sign at the time of the inspection the acknowledgement of receipt of the inspection report;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Assure that the lot number of a drug obtained from a stock bottle or other larger container:</text> <paragraph num="(a)"> <text>Is recorded in the office records;</text> </paragraph> <paragraph num="(b)"> <text>Can be correlated with any patient’s prescription for that drug; and</text> </paragraph> <paragraph num="(c)"> <text>Is immediately available for inspection; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except with regard to sample units, drug samples, and starter dosages in the possession and control of an authorized prescriber, assure that physical access to all prescription drugs is denied to all individuals at all times that a permit holder is not on the premises.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A permit holder may not dispense medications by:</text> <paragraph num="(1)"> <text>Mail order; or</text> </paragraph> <paragraph num="(2)"> <text>A refill.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For the purposes of this regulation, “refill” means an additional allotment of the same drug initially authorized by the original, written prescription. “Refill” does not prohibit a permit holder from dispensing the same or different drug through an additional or subsequent, written prescription.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Delegation of Dispensing Functions."> <paragraph num="A."> <text>A permit holder may delegate to an unlicensed person only mechanical acts involved in dispensing a drug.</text> </paragraph> <paragraph num="B."> <text>Delegation to a Physician Assistant.</text> <paragraph num="(1)"> <text>Except as required in §B(2) of this regulation, a permit holder may delegate to a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, the dispensing of a drug prescribed by:</text> <paragraph num="(a)"> <text>The permit holder to the permit holder’s patient; or</text> </paragraph> <paragraph num="(b)"> <text>A physician assistant or certified registered nurse practitioner who meets the requirements of Regulation .08 or .09 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The permit holder shall perform the final check.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Dispensing Prescription Drugs Prescribed by Physician Assistants."> <paragraph num="A."> <text>Except as required in §§B and C of this regulation, a permit holder may dispense a drug prescribed by a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, which authorizes the physician assistant to prescribe the drug.</text> </paragraph> <paragraph num="B."> <text>The permit holder shall perform the final check.</text> </paragraph> <paragraph num="C."> <text>The permit holder may dispense under this regulation only a drug that the permit holder is authorized to prescribe.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Dispensing Prescription Drugs Prescribed by Certified Registered Nurse Practitioners."> <paragraph num="A."> <text>Except as required in §§B and C of this regulation, a permit holder may dispense a drug prescribed by a certified registered nurse practitioner who is:</text> <paragraph num="(1)"> <text>Authorized under Health Occupations Article, Title 8, Annotated Code of Maryland, to prescribe the drug; and</text> </paragraph> <paragraph num="(2)"> <text>Working with the permit holder in the same office setting.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The permit holder shall perform the final check.</text> </paragraph> <paragraph num="C."> <text>The permit holder may dispense under this regulation only a drug that the permit holder is authorized to prescribe.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Records."> <paragraph num="A."> <text>A permit holder shall keep readily retrievable at each dispensing location:</text> <paragraph num="(1)"> <text>A copy of the dispensing permit issued by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A record of each final check;</text> </paragraph> <paragraph num="(3)"> <text>A copy of the form, signed and dated by the patient, maintained in accordance with COMAR 10.13.01.04, indicating the patient’s determination that a pharmacy is not conveniently available and demonstrating that the determination was made solely by the patient;</text> </paragraph> <paragraph num="(4)"> <text>The delegation agreement of any physician assistant for whom the permit holder dispenses prescription drugs at that location, including the name of the primary supervising physician and any alternate supervising physician;</text> </paragraph> <paragraph num="(5)"> <text>A list of the name and license number of all physician assistants for whom the permit holder dispenses drugs at that location;</text> </paragraph> <paragraph num="(6)"> <text>A list of the name, license number, and specialty of all certified registered nurse practitioners for whom the permit holder dispenses drugs at that location;</text> </paragraph> <paragraph num="(7)"> <text>The permit holder’s protocols for handling drug recalls, including the arrangements for notifying patients;</text> </paragraph> <paragraph num="(8)"> <text>The permit holder’s protocols for disposal of drugs;</text> </paragraph> <paragraph num="(9)"> <text>With respect to suppliers from whom the permit holder purchased prescription drugs:</text> <paragraph num="(a)"> <text>The name, address, and phone number of each supplier; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation including:</text> <paragraph num="(i)"> <text>For any pharmacy supplier, the number and the expiration date of the pharmacy permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and</text> </paragraph> <paragraph num="(ii)"> <text>For each wholesale supplier, the number and the expiration date of the distribution permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Any other purchasing, inventory, and dispensing records required by State or federal statutes or regulations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to meeting the requirements of Regulation .10A, the permit holder shall comply with any other State or federal law or regulation relating to dispensing of prescription drugs.</text> </paragraph> <paragraph num="C."> <text>A permit holder who dispenses CDS shall keep additional records available for inspection as required by COMAR 10.19.03.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Revision of Dispensing Permit."> <text>A permit holder may revise a permit twice during its term, without charge, to change the location at which prescriptions will be dispensed.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Lapse of Dispensing Permit."> <paragraph num="A."> <text>A permit automatically lapses if the permit holder:</text> <paragraph num="(1)"> <text>Dies;</text> </paragraph> <paragraph num="(2)"> <text>Fails to retain a valid and active Maryland medical license;</text> </paragraph> <paragraph num="(3)"> <text>Fails without good cause to file the annual report required by Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, within 15 days of the anniversary date of the date the permit was issued; or</text> </paragraph> <paragraph num="(4)"> <text>Fails without good cause to notify the Board of a change of address as required by Health Occupations Article, §14-316(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A lapsed permit may not be reinstated.</text> </paragraph> <paragraph num="C."> <text>The lapse of a permit is not in itself a bar to filing an application for a new permit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Written Notice on Reactivation of Dispensing."> <text>A permit holder who has reported pursuant to Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, that the permit holder has not personally dispensed prescription drugs during the previous year:</text> <paragraph num="A."> <text>Will not be subject to inspections by OCSA pursuant to Health Occupations Article, §12-102.1(b), Annotated Code of Maryland, unless the permit holder begins dispensing again; and</text> </paragraph> <paragraph num="B."> <text>May not begin to dispense prescription drugs again during the term of the dispensing permit without notifying the Board in advance in writing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Grounds for Revocation of Dispensing Permit."> <paragraph num="A."> <text>Subject to the Administrative Procedure Act, and in addition to any sanction for violation of Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, the Board may revoke a dispensing permit on any of the following grounds:</text> <paragraph num="(1)"> <text>Violating the attestations made pursuant to COMAR 10.13.01.05C(4);</text> </paragraph> <paragraph num="(2)"> <text>Violating State or federal statutes or regulations regarding prescribing or dispensing prescription drugs;</text> </paragraph> <paragraph num="(3)"> <text>Delegating dispensing duties outside the scope of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Dispensing prescription drugs prescribed by another outside the scope of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Dispensing at a location not designated on the permit;</text> </paragraph> <paragraph num="(6)"> <text>Being absent from the premises when prescription drugs are dispensed under the permit;</text> </paragraph> <paragraph num="(7)"> <text>Failing to comply with the applicable requirements of the Prescription Drug Monitoring Program set out in Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Failing to cooperate with an investigation by the Board or an inspection by OCSA; or</text> </paragraph> <paragraph num="(9)"> <text>Violating Regulations .06, .10, or .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a permit holder surrenders the permit while under investigation:</text> <paragraph num="(1)"> <text>The surrender does not prevent the Board from taking any appropriate disciplinary action under Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, or any other statute under which the Board has jurisdiction; and</text> </paragraph> <paragraph num="(2)"> <text>The permit holder may not apply for another permit again for a minimum of 5 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Summary Suspension of Dispensing Permit."> <paragraph num="A."> <text>The Board may summarily suspend a dispensing permit if it finds that the public safety, health, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="B."> <text>Procedures for summary suspension shall be governed by COMAR 10.32.02.08.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Fraud or Deception in Obtaining a Permit."> <text>Subject to the Administrative Procedure Act, a licensee who fraudulently or deceptively obtains or attempts to obtain a permit is guilty of violating Health Occupations Article, §14-404(a)(1), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Permit Holders Sanctioned for Violating the Medical Practice Act."> <paragraph num="A."> <text>If the Board sanctions a permit holder for violating Health Occupations Article, §14-404(a)(7), (8), (9), (10), or (28), or §14-404(b), Annotated Code of Maryland, the Board shall, in addition to any sanctions imposed on the permit holder under COMAR 10.32.02.07 or 10.32.02.10, revoke the permit.</text> </paragraph> <paragraph num="B."> <text>Subject to the requirement of §C of this regulation, reinstatement of a revoked permit is at the discretion of the Board.</text> </paragraph> <paragraph num="C."> <text>A revoked permit may not be reinstated for a minimum of 5 years from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Dispensing Without a Permit."> <text>Unless otherwise authorized by Health Occupations Article, §12-102, Annotated Code of Maryland, the dispensing of prescription drugs by a physician without a permit is a violation of Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, and also may be considered unprofessional conduct in the practice of medicine in violation of Health Occupations Article, §14-404(a)(3)(ii), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Interpretation."> <text>Nothing in this chapter relieves any permit holder from meeting the requirements of State or federal law or COMAR 10.13.01.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-102, 14-205, 14-306, 14-404, and 14-408; State Government Article, §§10-206 and 10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 26, 2018 (45:6 Md. R. 320)</annotation> </annotations> </chapter> <chapter num="24" heading="Licensure of Genetic Counselors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of genetic counseling.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §§C— D of this regulation, on or after January 1, 2024, an individual shall be licensed by the Board before the individual may practice genetic counseling.</text> </paragraph> <paragraph num="C."> <text>This chapter does not prohibit any student who is currently enrolled in an accredited educational program to qualify for a license as a genetic counselor from performing any of the procedures described in this chapter as part of that program’s clinical curriculum on genetic counseling.</text> </paragraph> <paragraph num="D."> <text>This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>The National Society of Genetic Counselors Code of Ethics (1992, revised 2017) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational program” means an educational program that is accredited by the national accrediting council or an equivalent accrediting body recognized by the national certifying board.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>“Certified genetic counselor” means an individual certified as a genetic counselor by a national certifying board.</text> </paragraph> <paragraph num="(4)"> <text>“Committee” means the Genetic Counseling Advisory Committee established under Health Occupations Article, §14-5G-05, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Disciplinary panel” means a disciplinary panel of the Board established under Health Occupations Article, §14-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>Genetic Assessment.</text> <paragraph num="(a)"> <text>“Genetic assessment” means the integration of genetic laboratory test results and other diagnostic studies with the medical histories of a patient and the patient’s family members to assess the risk for the patient or the patient’s family members of:</text> <paragraph num="(i)"> <text>A genetic or medical condition or disease; and</text> </paragraph> <paragraph num="(ii)"> <text>The recurrence of a genetic or medical condition or disease.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Genetic assessment” includes taking medical and family histories for the purpose of genetic counseling.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Good standing” has the meaning stated in COMAR 10.32.22.02.</text> </paragraph> <paragraph num="(8)"> <text>“Immediately available” means a qualified supervisor is able to provide necessary direction in person, by telephone, or by other electronic means.</text> </paragraph> <paragraph num="(9)"> <text>“License” means a license issued by the Board to practice genetic counseling.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed genetic counselor” means an individual who is licensed by the Board, in accordance with Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, to practice genetic counseling as a genetic counselor in the State.</text> </paragraph> <paragraph num="(11)"> <text>“Licensee” means a licensed genetic counselor or a supervised genetic counselor.</text> </paragraph> <paragraph num="(12)"> <text>“National accrediting council” means the Accreditation Council for Genetic Counseling, or its successor, that accredits education programs for genetic counselors.</text> </paragraph> <paragraph num="(13)"> <text>“National certifying board” means the American Board of Genetic Counseling, its predecessor, or its successor, that certifies genetic counselors.</text> </paragraph> <paragraph num="(14)"> <text>Practice Genetic Counseling.</text> <paragraph num="(a)"> <text>“Practice genetic counseling” means:</text> <paragraph num="(i)"> <text>Obtaining and evaluating the medical histories of a patient and the patient’s family members for purposes of a genetic assessment;</text> </paragraph> <paragraph num="(ii)"> <text>Discussing the features, natural history, means of diagnosis, genetic and environmental factors, and management of risk for genetic or medical conditions or diseases.</text> </paragraph> <paragraph num="(iii)"> <text>Identifying, ordering, and coordinating genetic laboratory tests and other diagnostic studies, as appropriate, for purposes of a genetic assessment;</text> </paragraph> <paragraph num="(iv)"> <text>Using the medical histories obtained from the patient and the patient’s family members for purposes of a genetic assessment;</text> </paragraph> <paragraph num="(v)"> <text>Explaining the clinical implications of genetic laboratory tests and other diagnostic studies and the results of the tests and studies and communicating the risk factors for genetic or medical conditions or diseases identified by a genetic assessment;</text> </paragraph> <paragraph num="(vi)"> <text>Evaluating the responses of a patient and the patient’s family members to the results of a genetic assessment and providing counseling and anticipatory guidance for a genetic or medical condition or disease;</text> </paragraph> <paragraph num="(vii)"> <text>Identifying and using community resources that provide medical, educational, financial, and psychosocial support and advocacy for a genetic or medical condition or disease; and</text> </paragraph> <paragraph num="(viii)"> <text>Providing written documentation of medical, genetic, and counseling information for a patient, a patient’s family members, or appropriate health care professionals.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice genetic counseling” does not include diagnosing or treating an illness, a disease, or a condition.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Qualified supervisor” means:</text> <paragraph num="(a)"> <text>A licensed genetic counselor who has practiced for a minimum of 3 years after passing the national certifying examination; or</text> </paragraph> <paragraph num="(b)"> <text>A physician who has been licensed in the State for a minimum of 5 years.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Supervised genetic counselor” means an individual who is licensed by the Board, in accordance with Health Occupations Article §14-5G-14, to practice genetic counseling under the supervision of a qualified supervisor.</text> </paragraph> <paragraph num="(17)"> <text>“Supervision” means the ongoing, direct, clinical review for the purposes of training or teaching by a qualified supervisor who monitors the performance of a supervised genetic counselor’s supervised interaction with a patient and provides consultations, chart reviews, guidance, and instructions with respect to the clinical skills and competencies of the supervised genetic counselor, as well as documented face-to-face meetings on at least a monthly basis.</text> </paragraph> <paragraph num="(18)"> <text>“Supervised interaction” means an interaction between a supervised genetic counselor and a patient where a qualified supervisor is immediately available.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Genetic Counseling Advisory Committee."> <paragraph num="A."> <text>The Board shall appoint members of the Committee as follows:</text> <paragraph num="(1)"> <text>Three individuals who practice genetic counseling who:</text> <paragraph num="(a)"> <text>Are in good standing with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Are a resident of the State with at least 1 year of active genetic counseling experience as a licensed, supervised, or certified genetic counselor within the 5-year period immediately preceding the date of the appointment; and</text> </paragraph> <paragraph num="(c)"> <text>On or after January 1, 2024, are licensed genetic counselors;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Three practicing licensed physicians who:</text> <paragraph num="(a)"> <text>Are in good standing with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Have experience working with genetic counselors; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One consumer member who:</text> <paragraph num="(a)"> <text>Shall be a member of the general public; and</text> </paragraph> <paragraph num="(b)"> <text>May not:</text> <paragraph num="(i)"> <text>Practice, or ever have practiced genetic counseling, or any other health care profession;</text> </paragraph> <paragraph num="(ii)"> <text>Be, or ever have been, in training to practice genetic counseling or any other health care profession;</text> </paragraph> <paragraph num="(iii)"> <text>Have a household member who is a health care professional or is in training to be a health care professional;</text> </paragraph> <paragraph num="(iv)"> <text>Participate, or ever have participated, in a commercial or professional field related to genetic counseling;</text> </paragraph> <paragraph num="(v)"> <text>Have a household member who participates in a commercial or professional field related to genetic counseling;</text> </paragraph> <paragraph num="(vi)"> <text>Have had, within 2 years before appointment, a financial interest in a person regulated by the Board; or</text> </paragraph> <paragraph num="(vii)"> <text>Have had, within 2 years of appointment, a financial interest in the provision of goods or services to genetic counselors or to the field of genetic counseling.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Tenure.</text> <paragraph num="(1)"> <text>The term of a member is 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed and qualifies.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second 3-year term, but the individual may not serve more than two consecutive 3-year terms.</text> </paragraph> <paragraph num="(5)"> <text>The terms of the initial members of the Committee shall expire as follows:</text> <paragraph num="(a)"> <text>Two members in 2024;</text> </paragraph> <paragraph num="(b)"> <text>Two members in 2025; and</text> </paragraph> <paragraph num="(c)"> <text>Three members in 2026.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs, the Board shall appoint a new member to serve on the Committee.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall only serve for the remainder of the term unless reappointed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Chair. From among its members, the Committee shall elect a chair every 2 years.</text> </paragraph> <paragraph num="E."> <text>Quorum.</text> <paragraph num="(1)"> <text>A quorum of the Committee consists of five members.</text> </paragraph> <paragraph num="(2)"> <text>Business may not be conducted at a Committee meeting unless there is a quorum.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In addition to the powers set forth elsewhere in this chapter, the Committee may develop and make recommendations to the Board in any matters related to the regulation of the practice of genetic counseling.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Code of Ethics."> <text>A genetic counselor in the State shall follow The National Society of Genetic Counselors Code of Ethics.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Initial Licensure as a Genetic Counselor."> <paragraph num="A."> <text>An applicant for a license as a licensed genetic counselor or a supervised genetic counselor shall:</text> <paragraph num="(1)"> <text>Complete an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the required application fee set by the Board in accordance with Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrate spoken and written competency in English by any of the following:</text> <paragraph num="(a)"> <text>Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of graduation from a recognized English-speaking professional school; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of receiving a grade of at least:</text> <paragraph num="(i)"> <text>26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and</text> </paragraph> <paragraph num="(ii)"> <text>79 on the total score of the Internet-based Test of English as a Foreign Language;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>If applicable, provide documentation of licensure, certification, or registration from all states and jurisdictions where the applicant has ever held a license, certificate, or registration in any health profession;</text> </paragraph> <paragraph num="(7)"> <text>Have no history of public disciplinary action taken, or pending, against any license currently or previously held or expired; and</text> </paragraph> <paragraph num="(8)"> <text>Complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for a license as a licensed genetic counselor or a supervised genetic counselor shall submit satisfactory evidence of graduation from an accredited educational program.</text> </paragraph> <paragraph num="C."> <text>Except as provided in § D of this regulation, an applicant for a license as a licensed genetic counselor shall submit to the Board satisfactory evidence of certification by a national certifying board.</text> </paragraph> <paragraph num="D."> <text>If an applicant for a license as a licensed genetic counselor does not meet the requirement under §C of this regulation, the applicant may qualify for licensure as a licensed genetic counselor if the applicant:</text> <paragraph num="(1)"> <text>Has worked as a genetic counselor for:</text> <paragraph num="(a)"> <text>At least 10 years before January 1, 2024; and</text> </paragraph> <paragraph num="(b)"> <text>At least 5 consecutive years immediately preceding the date on which the applicant submits the application for licensure;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has graduated from an accredited educational program;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board three letters of recommendation from licensed physicians who have been licensed for at least 5 years or certified genetic counselors eligible for licensure and who:</text> <paragraph num="(a)"> <text>Have worked with the applicant in an employment or professional setting for 3 years before the applicant submits the application for licensure; and</text> </paragraph> <paragraph num="(b)"> <text>Can attest to the applicant’s competency in providing genetic counseling services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>An applicant for a license as a supervised genetic counselor shall submit to the Board satisfactory evidence that the applicant has applied for the first available national certifying examination.</text> </paragraph> <paragraph num="F."> <text>The Board may not issue a supervised genetic counselor license to an applicant if the applicant has failed the national certifying examination two or more times.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Referral to Other Health Care Practitioners."> <text>If, while practicing genetic counseling, a licensed genetic counselor or supervised genetic counselor determines that a patient requires diagnosis, treatment, or management, the genetic counselor shall:</text> <paragraph num="A."> <text>Refer the patient to a licensed physician or another appropriate health care practitioner; and</text> </paragraph> <paragraph num="B."> <text>Document the referral in the patient’s medical record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Scope of Practice."> <text>The scope of practice of a licensed genetic counselor or a supervised genetic counselor includes the following:</text> <paragraph num="A."> <text>Obtaining and interpreting individual or family medical and developmental histories;</text> </paragraph> <paragraph num="B."> <text>Determining the mode of inheritance and risk of transmission of genetic conditions and of birth defects, including evaluating the risks from exposure to possible mutagens and teratogens;</text> </paragraph> <paragraph num="C."> <text>Discussing the inheritance features, natural history, means of diagnosis, and management of genetic conditions and birth defects;</text> </paragraph> <paragraph num="D."> <text>Identifying, ordering, coordinating, and explaining the clinical implications of genetic laboratory tests and other diagnostic studies and their results;</text> </paragraph> <paragraph num="E."> <text>Integrating genetic laboratory test results and other diagnostic studies with personal and family medical history to assess and communicate risk factors for genetic or medical conditions and diseases;</text> </paragraph> <paragraph num="F."> <text>Assessing psychosocial factors;</text> </paragraph> <paragraph num="G."> <text>Recognizing social, educational, and cultural issues;</text> </paragraph> <paragraph num="H."> <text>Evaluating the patient’s or family’s responses to the condition or risk of recurrence and providing patient-centered counseling and anticipatory guidance; and</text> </paragraph> <paragraph num="I."> <text>Facilitating informed decision-making about testing, management, and alternatives.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supervised Genetic Counselors."> <paragraph num="A."> <text>Term and Expiration.</text> <paragraph num="(1)"> <text>A supervised genetic counselor license shall expire on the earliest of:</text> <paragraph num="(a)"> <text>The issuance of a genetic counselor license to the supervised genetic counselor;</text> </paragraph> <paragraph num="(b)"> <text>On notice of the second failure of the supervised genetic counselor to pass the certification examination; or</text> </paragraph> <paragraph num="(c)"> <text>1 year after the date of issuance.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supervised genetic counselor license may not be renewed or extended beyond the 1-year expiration date.</text> </paragraph> <paragraph num="(3)"> <text>A supervised genetic counselor who has not passed the certification examination within two examination cycles may not continue practicing under the supervised genetic counselor license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision.</text> <paragraph num="(1)"> <text>A supervised genetic counselor may practice only under the supervision of a qualified supervisor.</text> </paragraph> <paragraph num="(2)"> <text>The supervised genetic counselor and the qualified supervisor shall enter into a written supervision contract that:</text> <paragraph num="(a)"> <text>Specifies the manner of supervision;</text> </paragraph> <paragraph num="(b)"> <text>Specifies any alternative qualified supervisors, as appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Is signed by the supervised genetic counselor and the qualified supervisor; and</text> </paragraph> <paragraph num="(d)"> <text>Is maintained by both the supervised genetic counselor and the qualified supervisor and made available upon request to the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Delegation of duties by a qualified supervisor beyond the scope of practice or failure to appropriately supervise a supervised genetic counselor may be considered unprofessional conduct in the practice of the qualified supervisor’s profession.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewal and Reinstatement of Licensure as a Licensed Genetic Counselor."> <paragraph num="A."> <text>At least 1 month before the license expires, the Board shall send a renewal notice to the licensed genetic counselor that states:</text> <paragraph num="(1)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued before the license expires; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee set by the Board in accordance with Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board may not renew a license until the Office of the Comptroller or the Maryland Department of Labor has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="(2)"> <text>An individual who has been licensed by the Board as a licensed genetic counselor may renew the license every 2 years on or before the date specified by the Board by:</text> <paragraph num="(a)"> <text>Submitting a renewal application on the form supplied by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Paying the required renewal fee set by the Board in accordance with Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Attesting to:</text> <paragraph num="(i)"> <text>Current certification by the national certifying board; or</text> </paragraph> <paragraph num="(ii)"> <text>Completion of at least 50 hours of continuing education credits approved by the national certifying board, earned during the 2-year period preceding the expiration of the license for genetic counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Documentation of Continuing Education.</text> <paragraph num="(a)"> <text>A genetic counselor shall obtain documentation of attendance at continuing education and retain the documentation for 6 years.</text> </paragraph> <paragraph num="(b)"> <text>The documentation shall contain, at a minimum, the following information:</text> <paragraph num="(i)"> <text>Program title;</text> </paragraph> <paragraph num="(ii)"> <text>Sponsor’s name;</text> </paragraph> <paragraph num="(iii)"> <text>Genetic counselor’s name;</text> </paragraph> <paragraph num="(iv)"> <text>Inclusive date or dates and location of the program;</text> </paragraph> <paragraph num="(v)"> <text>The number of continuing education hours earned; and</text> </paragraph> <paragraph num="(vi)"> <text>Documented verification that the genetic counselor attended the program by stamp, signature, print-out, or other official proof.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Proof of maintenance of certification by the national certifying board may be used to document compliance with the continuing education requirements specified in this regulation.</text> </paragraph> <paragraph num="(d)"> <text>The Board may request a genetic counselor to submit evidence of having met the continuing education requirements specified in this regulation.</text> </paragraph> <paragraph num="(e)"> <text>If a genetic counselor cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education credit hour.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement. The Board shall reinstate the license of a licensed genetic counselor who has failed to renew the license for any reason if the genetic counselor:</text> <paragraph num="(1)"> <text>Applies for reinstatement after the date the license expires;</text> </paragraph> <paragraph num="(2)"> <text>Provides documentation of current certification by the national certifying board;</text> </paragraph> <paragraph num="(3)"> <text>Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Board the reinstatement fee set by the Board in accordance with Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement of a Revoked or Surrendered License.</text> <paragraph num="(1)"> <text>On the application of an individual whose license has been revoked or surrendered, a disciplinary panel, on the affirmative vote of a majority of the quorum, may in its discretion reinstate a revoked or surrendered license.</text> </paragraph> <paragraph num="(2)"> <text>When a time period is not stated in an order for revocation or letter of surrender, the disciplinary panel may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order or letter of surrender.</text> </paragraph> <paragraph num="(3)"> <text>A revocation of a license may not be for less than 1 year.</text> </paragraph> <paragraph num="(4)"> <text>A disciplinary panel may not entertain an application for post-disciplinary reinstatement after an order of revocation unless:</text> <paragraph num="(a)"> <text>Any time period stated in the order has expired;</text> </paragraph> <paragraph num="(b)"> <text>Any condition set out in the order has been fulfilled;</text> </paragraph> <paragraph num="(c)"> <text>The applicant has filed a formal application and paid the fee set by the Board in accordance with Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>The applicant:</text> <paragraph num="(i)"> <text>Applies for reinstatement after the date the license expires;</text> </paragraph> <paragraph num="(ii)"> <text>Provides documentation of current certification by the national certifying board;</text> </paragraph> <paragraph num="(iii)"> <text>Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A disciplinary panel shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B.</text> </paragraph> <paragraph num="(6)"> <text>A disciplinary panel may not entertain applications for reinstatement if a revocation or surrender is permanent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Change in Name or Address."> <paragraph num="A."> <text>A licensed genetic counselor or supervised genetic counselor shall notify the Board in writing of a change of name or address within 60 days after the change.</text> </paragraph> <paragraph num="B."> <text>If a licensed genetic counselor or supervised genetic counselor fails to notify the Board within the time required under §A of this regulation, the licensed genetic counselor or supervised genetic counselor may be subject to an administrative penalty of $100.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Fees."> <text>The following fees are applicable to licensed genetic counselors and supervised genetic counselors:</text> <paragraph num="A."> <text>Initial licensed genetic counselor licensure fee—$300;</text> </paragraph> <paragraph num="B."> <text>Supervised genetic counselor licensure fee—$100;</text> </paragraph> <paragraph num="C."> <text>License renewal fees:</text> <paragraph num="(1)"> <text>License renewal fee—$250; and</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission fee—as determined by the Maryland Health Care Commission in accordance with COMAR 10.25.03;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement fee—$300;</text> </paragraph> <paragraph num="E."> <text>Written verification of license fee—$25; and</text> </paragraph> <paragraph num="F."> <text>Replacement of license fee—$25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Prohibited Conduct."> <paragraph num="A."> <text>Subject to the hearing provisions set forth in Health Occupations Article, §14-405, Annotated Code of Maryland, a disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensee or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="(3)"> <text>Is guilty of unprofessional or immoral conduct while practicing genetic counseling;</text> </paragraph> <paragraph num="(4)"> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(5)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(6)"> <text>Is habitually intoxicated;</text> </paragraph> <paragraph num="(7)"> <text>Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(10)"> <text>Willfully makes or files a false report or record in the practice of genetic counseling;</text> </paragraph> <paragraph num="(11)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report;</text> </paragraph> <paragraph num="(12)"> <text>Breaches patient confidentiality;</text> </paragraph> <paragraph num="(13)"> <text>Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient;</text> </paragraph> <paragraph num="(14)"> <text>Knowingly makes a misrepresentation while practicing genetic counseling;</text> </paragraph> <paragraph num="(15)"> <text>Knowingly practices genetic counseling with an unauthorized individual or aids an unauthorized individual in practicing genetic counseling;</text> </paragraph> <paragraph num="(16)"> <text>Knowingly delegates a genetic counseling duty to an unlicensed individual;</text> </paragraph> <paragraph num="(17)"> <text>Grossly overutilizes health care services;</text> </paragraph> <paragraph num="(18)"> <text>Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine;</text> </paragraph> <paragraph num="(19)"> <text>Is disciplined by a licensing or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the U.S. Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </paragraph> <paragraph num="(20)"> <text>Fails to meet appropriate standards for the delivery of genetic counseling services;</text> </paragraph> <paragraph num="(21)"> <text>Knowingly submits false statements to collect fees for which services are not provided;</text> </paragraph> <paragraph num="(22)"> <text>Has been subject to an investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes and has:</text> <paragraph num="(a)"> <text>Surrendered the license, if any, issued by the state or country; or</text> </paragraph> <paragraph num="(b)"> <text>Allowed the license, if any, issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(24)"> <text>Practices or attempts to practice beyond their authorized scope of practice;</text> </paragraph> <paragraph num="(25)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(26)"> <text>Practices or attempts to practice genetic counseling procedures or uses or attempts to use genetic assessments if the applicant or licensee has not received education and training in the performance of the procedure or the use of the genetic assessment;</text> </paragraph> <paragraph num="(27)"> <text>Fails to cooperate with a lawful investigation of the Board or a disciplinary panel;</text> </paragraph> <paragraph num="(28)"> <text>Fails to complete a criminal history records check under Health Occupations Article, §14-308.1, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(29)"> <text>Violates any provision of this title or any rule or regulation pertaining to genetic counseling that is adopted by the Board, the State, or the federal government.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Crimes of Moral Turpitude.</text> <paragraph num="(1)"> <text>Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5G-18(c), Annotated Code of Maryland, shall be held in accordance with COMAR 10.32.02.07.</text> </paragraph> <paragraph num="(2)"> <text>On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.</text> </paragraph> <paragraph num="(3)"> <text>After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Required Reports."> <paragraph num="A."> <text>Except as provided in §B, C, or F of this regulation, hospitals, related institutions, alternative health systems as defined in Health Occupations Article, §1-401, Annotated Code of Maryland, and employers shall file with the Board a report that the hospital, related institution, alternative health system, or employer limited, reduced, otherwise changed, or terminated any licensed genetic counselor or supervised genetic counselor for any reason that might be grounds for disciplinary action under Health Occupations Article, §14-5G-18, Annotated Code of Maryland, or any regulation in this chapter.</text> </paragraph> <paragraph num="B."> <text>If the action taken by a hospital, related institution, alternative health system, or employer under §A of this regulation relates to alcohol or drug impairment, the hospital, related institution, alternative health system, or employer is not required to report the licensed genetic counselor or supervised genetic counselor to the Board if:</text> <paragraph num="(1)"> <text>The hospital, related institution, alternative health system, or employer knows that the licensed genetic counselor or supervised genetic counselor is:</text> <paragraph num="(a)"> <text>In an alcohol or drug treatment program that is accredited by the Joint Commission or is certified by the Maryland Department of Health; or</text> </paragraph> <paragraph num="(b)"> <text>Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital, related institution, alternative health system, or employer is able to verify that the licensed genetic counselor or supervised genetic counselor remains in the treatment program until discharge; and</text> </paragraph> <paragraph num="(3)"> <text>The action or condition of the licensed genetic counselor or supervised genetic counselor has not caused injury to an individual while the genetic counselor is practicing genetic counseling.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a licensed genetic counselor or supervised genetic counselor enters, or is considering entering, an alcohol or drug treatment program that is accredited by the Joint Commission or that is certified by the Maryland Department of Health, the licensed genetic counselor or supervised genetic counselor shall notify the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor’s decision to enter the treatment program.</text> </paragraph> <paragraph num="D."> <text>If the licensed genetic counselor or supervised genetic counselor fails to provide the notice required under §C of this regulation, and the hospital, related institution, alternative health system, or employer learns that the licensed genetic counselor or supervised genetic counselor has entered a treatment program, the hospital, related institution, alternative health system, or employer shall report to the Board that the licensed genetic counselor or supervised genetic counselor has entered a treatment program and has failed to provide the required notice.</text> </paragraph> <paragraph num="E."> <text>Noncompliance.</text> <paragraph num="(1)"> <text>If the licensed genetic counselor or supervised genetic counselor is found to be noncompliant with the treatment program’s policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor’s noncompliance.</text> </paragraph> <paragraph num="(2)"> <text>On receipt of the notification required under §E(1) of this regulation, the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor shall report the licensed genetic counselor or supervised genetic counselor’s noncompliance to the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An individual is not required under this regulation to make any report that would be in violation of any federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records.</text> </paragraph> <paragraph num="G."> <text>The hospital, related institution, alternative health system, or employer shall submit a required report within 10 days of any action described in this regulation.</text> </paragraph> <paragraph num="H."> <text>A report made under this regulation is not subject to subpoena or discovery in a civil action other than a proceeding arising out of a hearing and decision of the Board under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Penalties, Fines, and Sanctioning Guidelines."> <paragraph num="A."> <text>An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, or any regulation in this chapter, is subject to a civil fine of not more than $5,000 to be levied by a disciplinary panel.</text> </paragraph> <paragraph num="C."> <text>The Board shall pay any penalty collected under §A or B of this regulation into the Board of Physicians Fund.</text> </paragraph> <paragraph num="D."> <text>Failure to Make a Required Report.</text> <paragraph num="(1)"> <text>A disciplinary panel may impose a fine up to $1,000 for a hospital, related institution, alternative health system, or employer who fails to make a report to the Board required by Regulation .14 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall deposit any funds collected under §D(1) of this regulation into the State’s General Fund.</text> </paragraph> </paragraph> <paragraph num="E."> <text>General Application of Sanctioning Guidelines.</text> <paragraph num="(1)"> <text>§§ E and F of this regulation and Regulation .16 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §F of this regulation, for violations of the sections of the Maryland Genetic Counseling Act listed in the sanctioning guidelines, a disciplinary panel may not impose a sanction less severe than the minimum listed in the sanctioning guidelines or more severe than the maximum listed in the sanctioning guidelines for each offense.</text> </paragraph> <paragraph num="(3)"> <text>Ranking of Sanctions.</text> <paragraph num="(a)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Suspension; and</text> </paragraph> <paragraph num="(iv)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(c)"> <text>A stayed suspension which does not meet the criteria for § E(3)(b) of this regulation is ranked as a reprimand.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the sanctioning guidelines.</text> </paragraph> <paragraph num="(5)"> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="(6)"> <text>If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines:</text> <paragraph num="(a)"> <text>The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and</text> </paragraph> <paragraph num="(b)"> <text>A disciplinary panel may impose concurrent sanctions based on other grounds violated.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Notwithstanding the sanctioning guidelines set forth in Regulation .16 of this chapter, in order to resolve a pending disciplinary action, a disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by a disciplinary panel, the administrative prosecutor, and the licensee.</text> </paragraph> <paragraph num="(8)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, a disciplinary panel may consider the aggravating and mitigating factors set forth in § F(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(9)"> <text>If a disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .16 of this chapter, the disciplinary panel shall state the reasons for doing so in its final decision and order.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, a disciplinary panel may consider the aggravating and mitigating factors set out in § F(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires a disciplinary panel or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>The existence of one or more of these factors does not impose on a disciplinary panel or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines.</text> </paragraph> <paragraph num="(4)"> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the incident;</text> </paragraph> <paragraph num="(c)"> <text>The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The misconduct was not premeditated;</text> </paragraph> <paragraph num="(h)"> <text>There was no potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The incident was isolated and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The offense had the potential for or actually did cause patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender committed a combination of factually discrete offenses adjudicated in a single action;</text> </paragraph> <paragraph num="(f)"> <text>The offender pursued his or her financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(g)"> <text>The patient was especially vulnerable;</text> </paragraph> <paragraph num="(h)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(i)"> <text>The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts to rehabilitate the offender were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A departure from the sanctioning guidelines set forth in Regulation .16 of this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Offenses Related to Continuing Medical Education Credits.</text> <paragraph num="(1)"> <text>If a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the licensee may be charged under one or more of the following, as appropriate:</text> <paragraph num="(a)"> <text>Health Occupations Article, §14-5G-18(a)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, §14-5G-18(a)(10), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Health Occupations Article, §14-5G-18(a)(11), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon finding a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5G-18, Annotated Code of Maryland, and the sanctioning guidelines.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Payment of Fines.</text> <paragraph num="(1)"> <text>An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, § 10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Sanctioning Guidelines for Genetic Counselors."> <paragraph num="A."> <text>Subject to provisions of Regulation .14E and F of this chapter, a disciplinary panel may impose sanctions as outlined in §B of this regulation on genetic counselors and supervised genetic counselors for violations of Health Occupations Article, §14-5G-18, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 14-205, and 14-5G-01—14-5G-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 01, 2025 (52:17 Md. R. 874)</annotation> </annotations> </chapter> <chapter num="25" heading="Supervised Medical Graduates"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the delegation of duties by a delegating physician to a supervised medical graduate in accordance with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>This chapter may not be construed:</text> <paragraph num="(1)"> <text>As establishing licensure, certification, or registration by the Board for supervised medical graduates;</text> </paragraph> <paragraph num="(2)"> <text>To apply to certified, registered, or licensed professionals or health occupation students acting in accordance with Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>To mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Physicians.</text> </paragraph> <paragraph num="(2)"> <text>“Delegated duty” means a routine medical or surgical act that does not require medical judgment and is performed under the supervision of a delegating physician.</text> </paragraph> <paragraph num="(3)"> <text>“Delegating physician” means a physician possessing an active license to practice medicine in the State who directs a supervised medical graduate to perform delegated duties.</text> </paragraph> <paragraph num="(4)"> <text>“Direct supervision” means oversight exercised by a delegating physician who is:</text> <paragraph num="(a)"> <text>Personally treating the patient;</text> </paragraph> <paragraph num="(b)"> <text>In the same medical office as the patient and the supervised medical graduate; and</text> </paragraph> <paragraph num="(c)"> <text>Immediately available to provide assistance and guidance to the supervised medical graduate for the duration of the delegated duty.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“ECFMG” means the Educational Commission for Foreign Medical Graduates or its successor.</text> </paragraph> <paragraph num="(6)"> <text>“LCME” means the Liaison Committee on Medical Education, an organization which accredits programs in medical education leading to the doctor of medicine degree in the United States and its territories and, in cooperation with the Committee on Accreditation of Canadian Medical Schools, in Canada.</text> </paragraph> <paragraph num="(7)"> <text>Medical Office.</text> <paragraph num="(a)"> <text>“Medical office” means any facility or location used for the delivery of health services.</text> </paragraph> <paragraph num="(b)"> <text>“Medical office” includes but is not limited to:</text> <paragraph num="(i)"> <text>A health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>An ambulatory surgical facility as defined in Health-General Article, §19-3B-01(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Supervised medical graduate” means an individual who meets the requirements of Regulations .03 and .04 of this chapter and is delegated duties by a delegating physician in accordance with Regulation .05 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications."> <text>A supervised medical graduate shall:</text> <paragraph num="A."> <text>Have a degree of:</text> <paragraph num="(1)"> <text>Doctor of Medicine from a school of medicine accredited by the LCME or its successor at the time of graduation;</text> </paragraph> <paragraph num="(2)"> <text>Doctor of Osteopathy from a school of osteopathy in the United States, its territories or possessions, Puerto Rico, or Canada that has standards for graduation equivalent to those established by the American Osteopathic Association; or</text> </paragraph> <paragraph num="(3)"> <text>Have a doctor of medicine degree from any other medical school and have successfully completed the requirements for and obtained ECFMG certification; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Receive a passing score in Part 1 and Part 2 of the United States Medical Licensing Examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements."> <paragraph num="A."> <text>An individual may not practice as a supervised medical graduate for a period of more than 2 years.</text> </paragraph> <paragraph num="B."> <text>A supervised medical graduate may only be delegated duties by a delegating physician while under the direct supervision of the physician.</text> </paragraph> <paragraph num="C."> <text>A supervised medical graduate shall wear an identification badge while on the premises of the medical office that states in readily visible type:</text> <paragraph num="(1)"> <text>The name of the supervised medical graduate; and</text> </paragraph> <paragraph num="(2)"> <text>The title “Supervised Medical Graduate”.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervised medical graduate shall comply with all additional requirements established by:</text> <paragraph num="(1)"> <text>Maryland Department of the Environment;</text> </paragraph> <paragraph num="(2)"> <text>The Joint Commission; and</text> </paragraph> <paragraph num="(3)"> <text>Any federal or State agency, including any federal or State laws or regulations.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A medical office employing a supervised medical graduate shall:</text> <paragraph num="(1)"> <text>Issue the supervised medical graduate an identification badge in accordance with §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Verify all credentials of the supervised medical graduate;</text> </paragraph> <paragraph num="(3)"> <text>Maintain documentation that the supervised medical graduate meets the requirements of this chapter on the premises of the medical office;</text> </paragraph> <paragraph num="(4)"> <text>Permit the Board to inspect the maintained documentation to ensure compliance with this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Verify all duties delegated to and performed by the supervised medical graduate are in accordance with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of Delegation to a Supervised Medical Graduate."> <paragraph num="A."> <text>A delegating physician may delegate duties consistent with national standards in the medical community and the approved policies and procedures of the medical office.</text> </paragraph> <paragraph num="B."> <text>A delegating physician is not required to be in the presence of a supervised medical graduate and the patient during the duration of the performance of delegated duties.</text> </paragraph> <paragraph num="C."> <text>A delegating physician may delegate duties to a supervised medical graduate only while physically on the premises of the same medical office as the supervised medical graduate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prohibited Conduct."> <paragraph num="A."> <text>A supervised medical graduate acting beyond the scope of this chapter may be:</text> <paragraph num="(1)"> <text>Considered to be engaged in the unlicensed practice of medicine; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-601,14-602, 14-606 Annotated Code of Maryland and COMAR 10.32.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A delegating physician, through either act or omission, facilitation, or otherwise enabling or forcing a supervised medical graduate to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §14-404(a), Annotated Code of Maryland including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine.</text> </paragraph> <paragraph num="C."> <text>A delegating physician may not:</text> <paragraph num="(1)"> <text>Require a supervised medical graduate to perform delegated duties; or</text> </paragraph> <paragraph num="(2)"> <text>Permit a supervised medical graduate to delegate duties to another individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Enforcement."> <text>The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §14-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 01, 2025 (52:17 Md. R. 874)</annotation> </annotations> </chapter> </subtitle> <subtitle num="33" heading="Board of Long-Term Care Administrators"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This subtitle governs the licensure, practice, and discipline of nursing home administrators and assisted living managers in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrator-in-training (AIT)” means an applicant approved by the Board to train to practice as a nursing home administrator in a nursing home under the supervision of a preceptor pursuant to this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>“Administrator-in-training (AIT) contract” means a document signed by an AIT and a preceptor which includes requirements of the AIT program.</text> </paragraph> <paragraph num="(3)"> <text>“Administrator-in-training (AIT) program” means a Board-approved program which consists of practical training and experience in nursing home administration.</text> </paragraph> <paragraph num="(4)"> <text>“Alternate assisted living manager” means an individual who is available to assume the duties of the licensed assisted living manager for a licensed assisted living program when the licensed assisted living manager is temporarily unavailable to perform the duties of an assisted living manager.</text> </paragraph> <paragraph num="(5)"> <text>“Assisted living manager” means an individual who is:</text> <paragraph num="(a)"> <text>Designated by an assisted living program to oversee the overall day-to-day operations of an assisted living program; and</text> </paragraph> <paragraph num="(b)"> <text>Responsible for the duties set forth under COMAR 10.07.14.15.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Assisted Living Program.</text> <paragraph num="(a)"> <text>“Assisted living program” means a residential or facility-based program for two or more residents that provides long-term housing and supportive services, supervision, personalized assistance, health-related services, or a combination of those that meets the needs of the individuals who are unable to perform or who need assistance in performing the activities of daily living or instrumental activities of daily living in a way that promotes optimum dignity and independence for the individuals.</text> </paragraph> <paragraph num="(b)"> <text>“Assisted living program” does not include:</text> <paragraph num="(i)"> <text>A nursing home as defined by Health-General Article, §19-1401, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A nursing facility as defined by Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vi)"> <text>Services provided by family members;</text> </paragraph> <paragraph num="(vii)"> <text>Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or</text> </paragraph> <paragraph num="(viii)"> <text>A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Human Services Article, §§6-508—6-513, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Board” means the State Board of Long-Term Care Administrators.</text> </paragraph> <paragraph num="(8)"> <text>“Central Repository” means the Criminal Justice Information System Central Repository of the Maryland Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Endorsement applicant” means an individual applying for a license to practice nursing home administration in the State who is licensed in another state to practice nursing home administration.</text> </paragraph> <paragraph num="(11)"> <text>“Family” means:</text> <paragraph num="(a)"> <text>A spouse;</text> </paragraph> <paragraph num="(b)"> <text>A child;</text> </paragraph> <paragraph num="(c)"> <text>A sibling;</text> </paragraph> <paragraph num="(d)"> <text>A parent;</text> </paragraph> <paragraph num="(e)"> <text>A grandparent;</text> </paragraph> <paragraph num="(f)"> <text>A niece or nephew; or</text> </paragraph> <paragraph num="(g)"> <text>An uncle or aunt.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Family-owned or family-operated nursing facility” means a nursing home owned or operated by any one or more of the following relatives of the AIT:</text> <paragraph num="(a)"> <text>A spouse;</text> </paragraph> <paragraph num="(b)"> <text>A parent;</text> </paragraph> <paragraph num="(c)"> <text>A child;</text> </paragraph> <paragraph num="(d)"> <text>A sibling;</text> </paragraph> <paragraph num="(e)"> <text>A grandparent;</text> </paragraph> <paragraph num="(f)"> <text>A grandchild;</text> </paragraph> <paragraph num="(g)"> <text>A stepparent;</text> </paragraph> <paragraph num="(h)"> <text>A stepchild;</text> </paragraph> <paragraph num="(i)"> <text>An uncle or aunt;</text> </paragraph> <paragraph num="(j)"> <text>A first cousin;</text> </paragraph> <paragraph num="(k)"> <text>A nephew or niece;</text> </paragraph> <paragraph num="(l)"> <text>A father-in-law or mother-in law;</text> </paragraph> <paragraph num="(m)"> <text>A son-in-law or daughter-in-law; or</text> </paragraph> <paragraph num="(n)"> <text>A brother-in-law or sister-in-law.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“License” means, unless the context requires otherwise, official authorization issued by the Board to practice as:</text> <paragraph num="(a)"> <text>A nursing home administrator under Health Occupations Article, Title 9, Subtitle 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>An assisted living manager under Health Occupations Article, Title 9, Subtitle 3A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Licensee” means, unless the context requires otherwise, an individual licensed by the Board to practice as:</text> <paragraph num="(a)"> <text>A nursing home administrator; or</text> </paragraph> <paragraph num="(b)"> <text>An assisted living manager.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“National Association of Long Term Care Administrator Boards (NAB)” means the organization that commissions the services of a third-party administrator of the State and national examinations for long term care administrators.</text> </paragraph> <paragraph num="(16)"> <text>“Nursing home” means a facility or institution as defined in Health Occupations Article, §9-101(i), Annotated Code of Maryland, and includes:</text> <paragraph num="(a)"> <text>A comprehensive care facility or extended care facility which offers non-acute inpatient care to residents who:</text> <paragraph num="(i)"> <text>Have a disease, chronic illness, condition, disability of advanced age, or terminal disease requiring maximal nursing care without continuous hospital services; and</text> </paragraph> <paragraph num="(ii)"> <text>Require medical services and nursing services rendered by or under the supervision of a licensed nurse together with convalescent, restorative, or rehabilitative services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A nursing facility as defined under federal or State law.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Nursing home administrator” means an individual licensed by the Board, who:</text> <paragraph num="(a)"> <text>Administers, directs, manages, supervises, or is in general administrative charge of a nursing home, whether or not the individual has an ownership interest in the facility, and whether or not the individual's functions and duties are shared with one or more individuals; or</text> </paragraph> <paragraph num="(b)"> <text>Is in supervisory control over one or more nursing home administrators of one or more nursing homes and has authority to substitute the supervisor's judgment for that of the administrator of record in the day-to-day operation of the facility.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Person” means any individual, guardian, personal representative, company, corporation, partnership, limited liability company, association, representative of any kind, or non-governmental entity.</text> </paragraph> <paragraph num="(19)"> <text>“Practice of assisted living management” means the exercise of final authority of any act or in the making of any decision involved in the planning, organizing, directing, or controlling of the day-to-day operation of an assisted living program.</text> </paragraph> <paragraph num="(20)"> <text>“Practice of nursing home administration” means the exercise of final authority of any act or in the making of any decision involved in the planning, organizing, directing, or controlling of the day-to-day operation of a nursing home.</text> </paragraph> <paragraph num="(21)"> <text>“Preceptor” means an individual certified to serve as an instructor in an AIT program to be a nursing home administrator, pursuant to this subtitle.</text> </paragraph> <paragraph num="(22)"> <text>“State standards exam” means an examination developed by the Board based on the following chapters:</text> <paragraph num="(a)"> <text>COMAR 10.07.02;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.07.09;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.09.10;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 10.09.24; and</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.15.03.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Powers of the Board."> <paragraph num="A."> <text>The Board shall exercise the powers provided by the laws of this State pertaining to the licensure, practice, and discipline of nursing home administrators and assisted living managers.</text> </paragraph> <paragraph num="B."> <text>Board staff and designees of the Board:</text> <paragraph num="(1)"> <text>May enter any nursing home and assisted living program in the State in order to carry out its functions; and</text> </paragraph> <paragraph num="(2)"> <text>Shall have access to the records related to licensure of any nursing home and assisted living program in the State in order to carry out its functions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Office of Health Care Quality may assist the Board in carrying out its functions.</text> </paragraph> <paragraph num="D."> <text>The Board has the authority to utilize consultant experts, as needed, in areas of its concern.</text> </paragraph> <paragraph num="E."> <text>From time to time, the Board shall make and publish regulations for the execution and enforcement of the laws related to the licensure, license renewal, and discipline of nursing home administrators and assisted living managers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Severability."> <text>If any provision of the regulations in this subtitle is declared unconstitutional or invalid, or the application of these regulations to any person or circumstances is held invalid, the applicability of the provision to other persons and circumstances and the constitutionality or validity of every other provision of these regulations is not to be affected.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-104; Health Occupations Article, §§9-101—9-501; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 15, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .06, .08, .10A, .13, .14, .15, .16, and .24 amended effective January 22, 1975 (2:2 Md. R. 86)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.24 repealed effective December 15, 1986 (13:25 Md. R. 2260)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.33.01.07 cited in Attorney General Opinion No. 85-030 (December 13, 1985)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.22 adopted effective December 15, 1986 (13:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 25, 2010 (37:2 Md. R. 68); March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A and C amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C, E amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D, F amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 27, 1992 (19:8 Md. R. 804); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 23, 1994 (21:10 Md. R. 844); April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D-1 adopted effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F, G amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended as an emergency provision effective November 3, 2005 (32:25 Md. R. 1938); amended permanently effective February 27, 2006 (33:4 Md. R. 352)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended effective April 27, 1992 (19:8 Md. R. 804); May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended as an emergency provision effective November 17, 1999 (26:25 Md. R. 1896); amended permanently effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective April 27, 1992 (19:8 Md. R. 804); May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective May 23, 1994 (21:10 Md. R. 844); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A—C amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B, C amended effective March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective April 27, 1992 (19:8 Md. R. 804); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68); March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 472); amended permanently effective June 17, 1996 (23:12 Md. R. 871)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376); June 28, 1999 (26:13 Md. R. 1019)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective May 23, 1994 (21:10 Md. R. 844); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B amended effective April 27, 1992 (19:8 Md. R. 804); March 20, 2000 (27:5 Md. R. 584); March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective October 4, 1999 (26:20 Md. R. 1546); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17D amended effective December 13, 1999 (26:25 Md. R. 1898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17E amended effective April 27, 1992 (19:8 Md. R. 804); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17F amended effective April 27, 1992 (19:8 Md. R. 804)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17-1 adopted effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18C amended effective January 25, 2010 (37:2 Md. R. 68)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 19, 2012 (39:5 Md. R. 383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended effective May 20, 2019 (46:10 Md. R. 489)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective February 27, 2017 (44:4 Md. R. 254)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16E amended effective May 20, 2019 (46:10 Md. R. 489)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .29 under COMAR 10.33.01 Nursing Home Administrators, under Subtitle 10.33 Board of Nursing Home Administrators, repealed effective January 19, 2026 (53:1 Md. R 22)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04 under COMAR 10.33.01 Nursing Home Administrators, under Subtitle 10.33 Board of Long-Term Care Administrators, adopted effective January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensing of Nursing Home Administrators"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs nursing home administrator applicants and licensees in the State pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure Qualifications, Applications, and Requirements."> <paragraph num="A."> <text>Except as otherwise provided by law, to qualify for an initial license to practice nursing home administration in the State, the applicant shall:</text> <paragraph num="(1)"> <text>Be at least 21 years old;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Obtain a passing score on the State standards exam;</text> </paragraph> <paragraph num="(5)"> <text>Obtain a passing score on the national licensure exams provided by NAB; and</text> </paragraph> <paragraph num="(6)"> <text>Except for an endorsement applicant, successfully complete the AIT program as set forth in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-303(3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The applicant shall submit to the Board:</text> <paragraph num="(1)"> <text>The completed Board online application;</text> </paragraph> <paragraph num="(2)"> <text>The application fee as set forth under COMAR 10.33.05.02D;</text> </paragraph> <paragraph num="(3)"> <text>Satisfactory evidence that the applicant has a bachelor’s or master’s degree in:</text> <paragraph num="(a)"> <text>Healthcare, health administration, or healthcare management, or the equivalent, with a concentration in healthcare administration or health administration or a master’s degree in business with a concentration in healthcare administration or health administration from an accredited college or university; or</text> </paragraph> <paragraph num="(b)"> <text>A field other than as described in §C(3)(a) of this regulation and has completed within the last 5 years a minimum 100-hour course approved by the Board in healthcare administration or health administration;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Two letters of character reference, which are signed and dated within 3 months prior to the date of application, from individuals engaged in either business or professional work on company or business letterhead:</text> <paragraph num="(a)"> <text>Who shall attest to the good moral character of the applicant; and</text> </paragraph> <paragraph num="(b)"> <text>Which may not be those from current employers or members of the applicant's family; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A passport type and size photograph of the applicant, which shall have been taken within 3 months prior to the date of application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except for an endorsement applicant, an applicant may take the State standards exam and NAB exams when the applicant has completed:</text> <paragraph num="(1)"> <text>A minimum of 8 months of the full-time 12-month AIT program or its equivalent or 12 months of the 18-month part-time AIT program or its equivalent; and</text> </paragraph> <paragraph num="(2)"> <text>The other requirements for licensure as specified in this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The 100-hour course for applicants with a bachelor’s or master’s degree in a field other than those described in §C(3)(a) of this regulation shall:</text> <paragraph num="(1)"> <text>Contain the subject matter relating to healthcare or health administration set forth under Regulation .03A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Be taken for credit for the purpose of initial licensure and be a course that has been approved by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An applicant who provides satisfactory evidence to the Board that the applicant is a registered nurse and who meets the requirements of Health Occupations Article, §9-302(f)(1), Annotated Code of Maryland, is not required to have a bachelor’s or master’s degree.</text> </paragraph> <paragraph num="G."> <text>An application shall be void if an applicant fails to meet all the requirements for licensure within 2 years of receipt of the application by the Board. To pursue licensure after that time, the applicant shall:</text> <paragraph num="(1)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(2)"> <text>Meet the requirements for licensure that are in effect at the time of reapplication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examinations for Nursing Home Administrators."> <paragraph num="A."> <text>Subjects for Examination. The State standards exam and the NAB exams shall include, at a minimum, the following subjects:</text> <paragraph num="(1)"> <text>Applicable standards of environmental health and safety;</text> </paragraph> <paragraph num="(2)"> <text>Local health and safety regulations;</text> </paragraph> <paragraph num="(3)"> <text>General administration;</text> </paragraph> <paragraph num="(4)"> <text>Psychology of patient care;</text> </paragraph> <paragraph num="(5)"> <text>Principles of medical care;</text> </paragraph> <paragraph num="(6)"> <text>Personal and social care;</text> </paragraph> <paragraph num="(7)"> <text>Therapeutic and supportive care and services in long-term care;</text> </paragraph> <paragraph num="(8)"> <text>Departmental organization and management; and</text> </paragraph> <paragraph num="(9)"> <text>Community interrelationships.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Scoring Examinations.</text> <paragraph num="(1)"> <text>The passing score for licensure examinations for a license shall be determined by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall determine a method of scoring each part of the exams separately and shall apply that method uniformly to all applicants taking the exams.</text> </paragraph> <paragraph num="(3)"> <text>Minimum Passing Scores. The following apply.</text> <paragraph num="(a)"> <text>The NAB national exams—scale score of 113 on the:</text> <paragraph num="(i)"> <text>NAB CORE exam; and</text> </paragraph> <paragraph num="(ii)"> <text>NAB NHA exam; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The State standards exam—75 percent correct answers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Administrator-in-Training Program—Requirements for AIT Participation."> <paragraph num="A."> <text>General Provisions.</text> <paragraph num="(1)"> <text>An AIT program is a supervised 12-month full-time, or 18-month part-time, internship during which the AIT works under the guidance and supervision of a preceptor who is a licensed administrator that meets the qualifications set forth in Regulations .05 and .06 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The AIT program is a required phase of education consisting of both the supervised practice of nursing home administration in the environment of the nursing home, performing and participating in the day-to-day duties of each position, when legally permissible, in each of the following service areas:</text> <paragraph num="(a)"> <text>Administration;</text> </paragraph> <paragraph num="(b)"> <text>Business office;</text> </paragraph> <paragraph num="(c)"> <text>Nursing;</text> </paragraph> <paragraph num="(d)"> <text>Resident activities;</text> </paragraph> <paragraph num="(e)"> <text>Social services;</text> </paragraph> <paragraph num="(f)"> <text>Medical records;</text> </paragraph> <paragraph num="(g)"> <text>Dietary services;</text> </paragraph> <paragraph num="(h)"> <text>Maintenance;</text> </paragraph> <paragraph num="(i)"> <text>Environmental services, including housekeeping and laundry;</text> </paragraph> <paragraph num="(j)"> <text>Rehabilitation services; and</text> </paragraph> <paragraph num="(k)"> <text>Quality assurance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prior to Board approval of the AIT program, the AIT applicant and preceptor shall develop an outline for the written course of instruction and dates of rotation schedule for the provision of practical training, experience, and learning situations that includes:</text> <paragraph num="(a)"> <text>The 11 basic service areas set forth in §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The AIT's past experience and allocation of clinical experiences in the nursing home; and</text> </paragraph> <paragraph num="(c)"> <text>Approval by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An AIT may not, during the normal working hours of the program, fill a specific, specialized position in the nursing home.</text> </paragraph> <paragraph num="(5)"> <text>The AIT shall be exposed to all shifts during the AIT program.</text> </paragraph> <paragraph num="(6)"> <text>If the AIT is a department head, notice shall be conspicuously posted in the nursing home stating who the acting department head will be while the AIT is performing training duties.</text> </paragraph> <paragraph num="(7)"> <text>If an applicant does not meet all of the requirements for licensure after having completed 12 months in the full-time or 18 months in the part-time AIT program, the preceptor and applicant have the option to work out a plan satisfactory to the Board to continue studying in the AIT program beyond the 12 or 18 months until all the requirements are met.</text> </paragraph> <paragraph num="(8)"> <text>The Board or Board committee shall interview each applicant and proposed preceptor, or preceptors, before the approval of an AIT program.</text> </paragraph> <paragraph num="(9)"> <text>After the interview, the AIT and preceptor shall sign an AIT contract and submit it to the Board for consideration of approval.</text> </paragraph> <paragraph num="(10)"> <text>The Board may approve the AIT program if it is satisfied that the background and circumstances of the applicant and preceptor, or preceptors, qualify them for the AIT program.</text> </paragraph> <paragraph num="(11)"> <text>A change of preceptor may be authorized by the Board upon submission of:</text> <paragraph num="(a)"> <text>Application by the proposed new preceptor;</text> </paragraph> <paragraph num="(b)"> <text>Evidence satisfactory to the Board that the proposed preceptor is certified by the Board; and</text> </paragraph> <paragraph num="(c)"> <text>A new signed AIT contract by the AIT and preceptor.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>If a preceptor is found by the Board to have failed to provide adequate training, the Board may cancel the preceptor's authorization to serve as a preceptor for a period of time prescribed by the Board.</text> </paragraph> <paragraph num="(13)"> <text>The AIT and preceptor shall comply with the AIT contract.</text> </paragraph> <paragraph num="(14)"> <text>An individual duly registered as an AIT whose internship is interrupted by service in the armed forces of the United States shall be permitted to resume the internship without loss of credit at any time within 1 year after the date of the AIT's separation from active service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application Requirements.</text> <paragraph num="(1)"> <text>The Board may approve an application for a nursing home AIT program only if it determines that the application contains satisfactory evidence that:</text> <paragraph num="(a)"> <text>The applicant is at least 21 years old;</text> </paragraph> <paragraph num="(b)"> <text>The applicant is of good moral character;</text> </paragraph> <paragraph num="(c)"> <text>The applicant's training will be supervised by a Board-certified preceptor; and</text> </paragraph> <paragraph num="(d)"> <text>The AIT program meets the other requirements set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The training proposed to be provided to the applicant shall be satisfactory to the Board.</text> </paragraph> <paragraph num="(3)"> <text>The applicant shall participate in training provided in:</text> <paragraph num="(a)"> <text>A nursing home licensed in the State, as defined in COMAR 10.33.01.02B; and</text> </paragraph> <paragraph num="(b)"> <text>Not more than two licensed nursing homes in the State approved by the Board for training. If two nursing homes are utilized for training, one shall have at least 60 beds.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If there are subject areas as specified in the list of subjects provided in §A(2) of this regulation that are not available in the nursing home approved by the Board for training, the Board may require training in other facilities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Credit for Prior Experience.</text> <paragraph num="(1)"> <text>The AIT program is a minimum of 12 months for full-time programs or 18 months for part-time programs unless, upon request from the applicant to review prior work experience, the Board awards credit for prior experience within the last 5 years. The amount of credit awarded is at the discretion of the Board, based on an applicant’s work experience demonstrating exposure to the core of knowledge set forth in Regulation .04A(2) of this chapter, but may not exceed;</text> <paragraph num="(a)"> <text>Six months for a hospital assistant administrator;</text> </paragraph> <paragraph num="(b)"> <text>Eight months for a hospital administrator;</text> </paragraph> <paragraph num="(c)"> <text>Six months for a nursing home assistant administrator;</text> </paragraph> <paragraph num="(d)"> <text>Six months for a department head;</text> </paragraph> <paragraph num="(e)"> <text>Three months for an Executive Director of a continuing care retirement community;</text> </paragraph> <paragraph num="(f)"> <text>Three months for an assisted living manager;</text> </paragraph> <paragraph num="(g)"> <text>Three months for a healthcare-related senior management official; or</text> </paragraph> <paragraph num="(h)"> <text>Three months for a non-healthcare-related senior management official.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Qualifying Experience for Healthcare Related Professions in §C(1)(a)—(f) of this regulation. The minimum experience required for receiving credit towards the AIT program includes:</text> <paragraph num="(a)"> <text>A minimum of 18 months as a full-time employee, with line responsibility for hiring, firing, budget, and supervision of at least one department comprised of ten or more employees; and</text> </paragraph> <paragraph num="(b)"> <text>Reporting directly to the nursing home administrator or chief executive officer.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Qualifying Experience for Healthcare Related or Non-Healthcare Related Senior Management Official in §C(1)(g) and (h) of this regulation. The following requirements set the minimum experience required for receiving credit:</text> <paragraph num="(a)"> <text>Minimum of 18 months as a full-time senior management official of a single nursing home or entity; and</text> </paragraph> <paragraph num="(b)"> <text>Administrative responsibility for the total operation of the nursing home or entity and its multiple departments, as applicable.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Experience credit can be awarded on a month-to-month basis totaling 12 months for:</text> <paragraph num="(a)"> <text>An individual who has worked as a licensed nursing home administrator in another state;</text> </paragraph> <paragraph num="(b)"> <text>A resident or intern in a program offered by an accredited college or university for the purpose of satisfying the requirements for a baccalaureate or master's degree in healthcare administration; or</text> </paragraph> <paragraph num="(c)"> <text>An individual who has successfully completed an AIT program in another state, if the program is substantially comparable to the AIT program in the State, as determined by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for AIT Program."> <paragraph num="A."> <text>The preceptor for an AIT shall be currently certified by the Board under Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The preceptor may not be responsible for more than two AITs at any one time. The preceptor shall devote a minimum of 16 hours per week of direct, on-site supervision for each AIT, which may be on an individual or combined basis in the case of two AITs.</text> </paragraph> <paragraph num="C."> <text>The preceptor may be the administrator of record of the facility in which the training is to take place, provided that the preceptor has had a minimum of 30 days of oversight in the facility where the training is to take place immediately prior to beginning the AIT program.</text> </paragraph> <paragraph num="D."> <text>The preceptor may not be the administrator of record for a facility other than the facility designated for training.</text> </paragraph> <paragraph num="E."> <text>A minimum of 80 percent of the training shall occur during 8 consecutive hours for full-time programs or 6 consecutive hours for part-time programs each day (except for regular days off) between the hours of 7 a.m. and 7 p.m.</text> </paragraph> <paragraph num="F."> <text>A minimum of 40 hours per week for full-time or 30 hours per week for part-time shall be devoted to continuous, bona fide training activities which include observing and performing the day-to-day duties of each position, when legally permissible, in the service areas referred to in Regulation .04A(2) of this chapter.</text> </paragraph> <paragraph num="G."> <text>The applicant may spend a maximum of 50 percent of the training in a family-owned or family-operated nursing home, and the remainder of the time shall be spent in another Board-approved facility.</text> </paragraph> <paragraph num="H."> <text>An employee may not be a preceptor for their employer.</text> </paragraph> <paragraph num="I."> <text>Required AIT Reports.</text> <paragraph num="(1)"> <text>The AIT and preceptor shall maintain a progress report for the training program on the forms provided by the Board for every 3 months of the training program.</text> </paragraph> <paragraph num="(2)"> <text>The report shall:</text> <paragraph num="(a)"> <text>Be submitted by the AIT and the preceptor to the Board's office on the dates specified by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Include the following:</text> <paragraph num="(i)"> <text>A detailed description of activity or area covered, or both, and dates of rotation, and, if applicable, an explanation for any changes to the Board-approved rotation schedule;</text> </paragraph> <paragraph num="(ii)"> <text>A detailed analysis of any problems observed, new experiences, insights gained, and the AIT's role in problem solutions; and</text> </paragraph> <paragraph num="(iii)"> <text>The course of instruction outline including signatures from the preceptor, AIT, and department managers to verify that the AIT trained in those departments.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the reports are not submitted to the Board's office by the date specified by the Board, the AIT shall be considered to have violated the terms of the AIT contract.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Discontinuance of AIT Status in a Nursing Home.</text> <paragraph num="(1)"> <text>The AIT and the preceptor shall report discontinuance within 10 days to the Board.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 days of the date of discontinuation, the preceptor shall file a report to the Board detailing the AIT's experience and abilities.</text> </paragraph> <paragraph num="(3)"> <text>The AIT may fulfill the training requirement in no more than two licensed nursing facilities, with a lapse of no more than 90 days between the two periods of training.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Certification of Preceptors."> <paragraph num="A."> <text>The Board shall issue a certificate of qualification to be a preceptor in the AIT program if the following conditions are met:</text> <paragraph num="(1)"> <text>The preceptor holds and has held a license from the Board for 1 year or longer;</text> </paragraph> <paragraph num="(2)"> <text>The proposed preceptor has been satisfactorily employed in nursing home administration for a minimum of 3 years as the nursing home administrator of record;</text> </paragraph> <paragraph num="(3)"> <text>The proposed preceptor has no disciplinary action pending nor is currently under investigation by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Individuals seeking certification as preceptors in the AIT program shall submit evidence of the successful completion of the preceptor training course offered by NAB; and</text> </paragraph> <paragraph num="(5)"> <text>The proposed preceptor has either been employed full time as a nursing home administrator of record for a minimum of 2 of the past 3 years immediately before application to precept or meets the following qualifications:</text> <paragraph num="(a)"> <text>Works on the same property as the nursing home where the AIT program will be conducted;</text> </paragraph> <paragraph num="(b)"> <text>Is able to demonstrate to the Board the proposed preceptor’s active, direct, and material management and daily operations of the nursing home; and</text> </paragraph> <paragraph num="(c)"> <text>Has been actively licensed as a nursing home administrator for a minimum of 5 years immediately before application to precept.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the proposed preceptor has not precepted an AIT program within the past 5 years, the proposed preceptor shall recertify as a preceptor by completing the preceptor training course offered by NAB.</text> </paragraph> <paragraph num="C."> <text>The Board may disapprove a preceptor for a training program:</text> <paragraph num="(1)"> <text>If the preceptor has failed to remain in compliance with this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>At any time for good cause.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="License by Endorsement."> <paragraph num="A."> <text>The Board, in its discretion, may grant a license by endorsement to practice nursing home administration in the State, upon satisfactory evidence that the endorsement applicant, in addition to the requirements of this section, meets all the qualifications and requirements for a nursing home administrator license set forth in Regulation .02 of this chapter, except that the endorsement applicant is not required to:</text> <paragraph num="(1)"> <text>Take the NAB exams set forth under Regulation .03 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Participate in the AIT program that is set forth under Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The endorsement applicant shall:</text> <paragraph num="(1)"> <text>Possess a valid license as a nursing home administrator, which has not been revoked or suspended in each state from which the applicant has ever received a nursing home administrator license or reciprocal endorsement;</text> </paragraph> <paragraph num="(2)"> <text>Provide satisfactory evidence of having completed one year as the full-time nursing home administrator of record in a nursing home within the last 5 years; and</text> </paragraph> <paragraph num="(3)"> <text>Be familiar with State and local health and safety regulations related to nursing homes by evidence of a passing score on the State standards exam.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To be granted a State nursing home administrator license, the endorsement applicant shall possess a nursing home administrator license in other states that shall:</text> <paragraph num="(1)"> <text>Maintain a system and standard of qualification and examination for a license, which are substantially equivalent to those required by this State; and</text> </paragraph> <paragraph num="(2)"> <text>Give similar recognition and endorsement to nursing home administrator licenses of this State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may waive:</text> <paragraph num="(1)"> <text>The education requirements of COMAR 10.33.02.02C(3), if the endorsement applicant provides satisfactory evidence to the Board that the endorsement applicant is licensed and has practiced as a nursing home administrator for at least 3 years in another state; and</text> </paragraph> <paragraph num="(2)"> <text>The State standards examination, if the endorsement applicant provides satisfactory evidence to the Board that the endorsement applicant met the requirements of Health Occupations Article, §9-306(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Provisional License."> <paragraph num="A."> <text>As an exception to the licensure requirements in this chapter, a nursing home shall immediately appoint an individual not licensed to practice as a nursing home administrator to act as the interim nursing home administrator if:</text> <paragraph num="(1)"> <text>A licensed nursing home administrator in the State leaves or is removed from the position as a nursing home administrator by death or other unexpected cause; and</text> </paragraph> <paragraph num="(2)"> <text>A licensed nursing home administrator in the State is unavailable to fill the position.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The departure of the licensed nursing home administrator specified under §A of this regulation is by unexpected cause if:</text> <paragraph num="(1)"> <text>The departure occurred suddenly;</text> </paragraph> <paragraph num="(2)"> <text>The departure was unforeseen; and</text> </paragraph> <paragraph num="(3)"> <text>There was insufficient time for the nursing home to obtain the services of a nursing home administrator licensed in the State.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The appointed non-licensed individual may begin acting as the interim nursing home administrator upon appointment by the nursing home.</text> </paragraph> <paragraph num="D."> <text>No later than 24 hours after the appointment of the non-licensed individual as interim nursing home administrator, under §A of this regulation, the nursing home shall:</text> <paragraph num="(1)"> <text>File an application with the Board requesting a provisional license for the non-licensed individual;</text> </paragraph> <paragraph num="(2)"> <text>Notify the Board of the circumstances involved in the departure of the licensed nursing home administrator;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Board of the credentials of the non-licensed individual; and</text> </paragraph> <paragraph num="(4)"> <text>If requested, provide the Board with the acts the nursing home took, or is taking, to hire a nursing home administrator who is licensed in the State.</text> </paragraph> </paragraph> <paragraph num="E."> <text>State and National Criminal History Records Check.</text> <paragraph num="(1)"> <text>The appointed non-licensed individual shall immediately submit to a criminal history records check, in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>A criminal history records check is not required if the appointed non-licensed individual is actively licensed by a health occupations board in the State who previously has completed a criminal history records check required for licensure, certification, or registration.</text> </paragraph> <paragraph num="(3)"> <text>The Board may deny approval of an appointment based on the results of a criminal history records check after consideration of the factors listed in Health Occupations Article, §9–308(b)(1), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Provisional License. The Board may issue a provisional license to the applicant if the Board determines that:</text> <paragraph num="(1)"> <text>The applicant is of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>The departure of the licensed nursing home administrator was by unexpected cause; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant is capable of adequately administering the nursing home for the provisional period.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the Board grants the application for the provisional nursing home administrator license, the provisional license is in effect for 90 days from the date of the departure of the licensed nursing home administrator. For good cause shown, the Board may extend the provisional license period by 30 days.</text> </paragraph> <paragraph num="H."> <text>Denial of Provisional License.</text> <paragraph num="(1)"> <text>If the application for a provisional license is denied by the Board, the nursing home may request a meeting with the Board to contest the denial.</text> </paragraph> <paragraph num="(2)"> <text>The nursing home shall provide the request for a meeting to the Board within 5 business days of the denial.</text> </paragraph> <paragraph num="(3)"> <text>If the nursing home requests a meeting, the appointed non-licensed individual may remain acting as the interim nursing home administrator until the Board issues a decision.</text> </paragraph> <paragraph num="(4)"> <text>If the Board denies the application for a provisional license after a meeting contesting the initial denial, the non-licensed individual shall immediately cease acting as the interim nursing home administrator upon receipt of the decision.</text> </paragraph> <paragraph num="(5)"> <text>If the nursing home does not file a timely request for a meeting with the Board, the non-licensed individual shall cease acting as the interim nursing home administrator within 5 business days of the denial.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the non-licensed individual is required to cease acting as the interim nursing home administrator under §H of this regulation, and a nursing home administrator licensed in the State remains unavailable to fill the nursing home administrator position, the nursing home may appoint another non-licensed individual as set forth in this regulation.</text> </paragraph> <paragraph num="J."> <text>As a result of §I of this regulation, if the nursing home appoints another non-licensed individual, and a provisional license is granted, the provisional license is in effect for 90 days from the date of the departure of the nursing home administrator licensed in the State, unless the Board extends the provisional license, for good cause shown, for an additional 30 days.</text> </paragraph> <paragraph num="K."> <text>Upon request by the nursing home, for reasonable cause, the Board may extend the 24-hour time period for meeting the requirements of §D of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Renewals."> <paragraph num="A."> <text>The Board shall send each licensee a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current license or current registration expires;</text> </paragraph> <paragraph num="(2)"> <text>Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee as specified in COMAR 10.33.05.02D.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At least 30 days before the current license expires, the Board shall send the renewal notice by electronic means to the last known electronic mail address or first-class mail to the physical address of the licensee.</text> </paragraph> <paragraph num="C."> <text>Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.33.04.</text> </paragraph> <paragraph num="D."> <text>Licensees shall complete an implicit bias and structural racism training program approved by the Cultural and Linguistic Health Care Professional Competency Program in accordance with Health-General Article, §20-1306, Annotated Code of Maryland, for an applicant’s first renewal after April 1, 2026.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reinstatement After License Expiration."> <paragraph num="A."> <text>The Board shall reinstate an individual whose license has expired if the individual:</text> <paragraph num="(1)"> <text>Meets the renewal requirements of this chapter and Health Occupations Article, §9-312, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Pays the reinstatement fee as specified under COMAR 10.33.05.02D; and</text> </paragraph> <paragraph num="(3)"> <text>Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.33.04.01.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A previously licensed nursing home administrator who fails to apply for licensure reinstatement within 5 years after the expiration date of the license shall meet the requirements for a new license in effect at the time of the request in order to be licensed to practice as a nursing home administrator in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Inactive Status and Reactivation."> <paragraph num="A."> <text>In accordance with Health Occupations Article, §9-312.1, Annotated Code of Maryland, a request by an active licensee to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(1)"> <text>Completed Board-approved inactive status application; and</text> </paragraph> <paragraph num="(2)"> <text>Payment of the required, non-refundable, biennial inactive status fee set forth in COMAR 10.33.05.02D.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual:</text> <paragraph num="(1)"> <text>May apply for inactive status only if the individual’s license is still active at the time the inactive status application request is made;</text> </paragraph> <paragraph num="(2)"> <text>Shall renew and pay the biennial inactive status fee during each renewal period; and</text> </paragraph> <paragraph num="(3)"> <text>Is not authorized to and may not practice as a nursing home administrator in the State while on inactive status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reactivation.</text> <paragraph num="(1)"> <text>The Board shall reactivate the license of a licensee who is on inactive status if the licensee:</text> <paragraph num="(a)"> <text>Completes an application form for reactivation of the license before expiration of the 2-year term of inactive status on the form required by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Complies with the renewal requirements in effect at the time the licensee seeks to reactivate the license;</text> </paragraph> <paragraph num="(c)"> <text>Meets the continuing education requirements set by the Board;</text> </paragraph> <paragraph num="(d)"> <text>Has not practiced as a nursing home administrator in the State while on inactive status;</text> </paragraph> <paragraph num="(e)"> <text>Pays all appropriate fees set by the Board under COMAR 10.33.05.02D;</text> </paragraph> <paragraph num="(f)"> <text>Has been on inactive status for less than 5 years; and</text> </paragraph> <paragraph num="(g)"> <text>Is otherwise entitled to be licensed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before the Board may reactivate the license of an individual who has been on inactive status for 5 years or more, the individual shall:</text> <paragraph num="(a)"> <text>Submit a new online application;</text> </paragraph> <paragraph num="(b)"> <text>Pay all appropriate fees set by the Board under COMAR 10.33.05.02D;</text> </paragraph> <paragraph num="(c)"> <text>Complete a 100-hour Board–approved course in healthcare administration or health administration;</text> </paragraph> <paragraph num="(d)"> <text>Pass the State standards exam for nursing home administrators; and</text> </paragraph> <paragraph num="(e)"> <text>Submit satisfactory evidence of having completed a State and national criminal history records check in accordance with Health Occupations Article, §9–302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A nursing home administrator whose inactive status expires before the license is reactivated shall meet the reinstatement requirements set forth in Health Occupations Article, §9-312, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Incomplete Applications."> <paragraph num="A."> <text>The Board is not required to consider an application that is incomplete.</text> </paragraph> <paragraph num="B."> <text>The applicant shall submit to the Board any additional relevant documentation requested by the Board if the Board determines the application documentation received is incomplete or insufficient.</text> </paragraph> <paragraph num="C."> <text>The Board may hold an incomplete application for a license for up to 1 year from the date of receipt.</text> </paragraph> <paragraph num="D."> <text>After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.</text> </paragraph> <paragraph num="E."> <text>If an application has been closed under §D of this regulation, to obtain a license the applicant shall submit a new application fee and otherwise comply with all applicable license requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Display of License."> <text>Each individual licensed as a nursing home administrator in the State shall display printed verification of licensure in a conspicuous place in the office or place of business or employment of the licensee.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Change of Mailing Address, Legal Name, or Email Address."> <paragraph num="A."> <text>A licensed nursing home administrator shall give the Board written or electronic notice within 30 days of a change of:</text> <paragraph num="(1)"> <text>Mailing address;</text> </paragraph> <paragraph num="(2)"> <text>Legal name; or</text> </paragraph> <paragraph num="(3)"> <text>Email address.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fine as set forth under COMAR 10.33.05.02D.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§9-205, 9-301—9-316.1, and 9-401—9-501, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="03" heading="Licensing of Assisted Living Managers"> <regulation prefix="Regulation" num=".01" heading="Effective Date and Scope."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, effective July 1, 2026, an individual shall be licensed by the Board before the individual may practice as an assisted living manager in the State.</text> </paragraph> <paragraph num="B."> <text>This chapter governs assisted living managers in the State pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure Qualifications, Applications, and Requirements—Applicant I."> <paragraph num="A."> <text>This regulation applies to applicants who have practiced as an assisted living manager in a licensed assisted living program in the State prior to July 1, 2026.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided by law, to qualify for an initial license to practice assisted living management in Maryland, an applicant shall:</text> <paragraph num="(1)"> <text>Be at least 21 years old;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Submit the following to the Board:</text> <paragraph num="(a)"> <text>The completed Board online application;</text> </paragraph> <paragraph num="(b)"> <text>The application fee as set forth in COMAR 10.33.05.02D; and</text> </paragraph> <paragraph num="(c)"> <text>A passport type and size photograph of self, which shall have been taken within 3 months prior to the date of application;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Meet, and attest on the application to meeting, the following requirements:</text> <paragraph num="(a)"> <text>Has obtained a high school diploma, a high school equivalency diploma, or other appropriate education as specified under COMAR 10.07.14.15; or</text> </paragraph> <paragraph num="(b)"> <text>For level 3 licensed programs, set forth under COMAR 10.07.14.05, has completed at least one of the following:</text> <paragraph num="(i)"> <text>A 4-year, college-level degree;</text> </paragraph> <paragraph num="(ii)"> <text>2 years of experience in a healthcare related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or</text> </paragraph> <paragraph num="(iii)"> <text>2 years of experience in a healthcare related field and successful completion of an 80-hour assisted living manager training course approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Completed an 80-hour assisted living manager training course and passed the course examination as required under Health–General Article, §19–1807(a), Annotated Code of Maryland, and Health Occupations Article, §9-3A-02(a)(5)(i), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(d)"> <text>Submitted to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland. The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-3A-03(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Is certified in:</text> <paragraph num="(i)"> <text>Basic first aid taught by a first aid instructor certified by a national organization, except licensed practical nurses and registered nurses licensed in this State who are not required to attest to being certified in basic first aid; and</text> </paragraph> <paragraph num="(ii)"> <text>Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Completed training in:</text> <paragraph num="(i)"> <text>Fire and life safety;</text> </paragraph> <paragraph num="(ii)"> <text>Infection control, including standard precautions;</text> </paragraph> <paragraph num="(iii)"> <text>Emergency disaster plans; and</text> </paragraph> <paragraph num="(iv)"> <text>Basic food safety.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Exemptions for the 80-Hour Training Course. Except as otherwise provided by law, an applicant is exempt from the 80-hour training course, pursuant to Health–General Article, §19–1807(d)(1), Annotated Code of Maryland, if the applicant meets, and attests to meeting, at least one of the following:</text> <paragraph num="(1)"> <text>Is employed by an assisted living program, has enrolled in the 80-hour training course, and expects to complete the course within 6 months;</text> </paragraph> <paragraph num="(2)"> <text>Has been employed as an assisted living manager in the State for 1 year prior to January 1, 2006; or</text> </paragraph> <paragraph num="(3)"> <text>Is licensed as a nursing home administrator in the State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If an individual is licensed through the exemption in §C(1) of this regulation, the licensee shall:</text> <paragraph num="(1)"> <text>Complete the 80-hour course, which includes passing the course examination, within 6 months of enrollment in the course, in accordance with COMAR 10.07.14.16E(1); and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board satisfactory evidence that the licensee has completed the course, within 15 days from the date the licensee was notified of their successful completion of the course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Qualifications, Applications, and Requirements—Applicant II."> <paragraph num="A."> <text>This regulation applies to applicants who have not practiced as an assisted living manager in a licensed assisted living program in the State prior to July 1, 2026.</text> </paragraph> <paragraph num="B."> <text>Except as otherwise provided by law, to qualify for an initial license to practice assisted living management in the State, an applicant shall:</text> <paragraph num="(1)"> <text>Be at least 21 years old;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Provide satisfactory evidence to the Board that the applicant:</text> <paragraph num="(a)"> <text>Has obtained a high school diploma, a high school equivalency diploma, or other appropriate education as specified under COMAR 10.07.14.15; or</text> </paragraph> <paragraph num="(b)"> <text>For level 3 licensed programs, set forth under COMAR 10.07.14.05, has completed at least one of the following:</text> <paragraph num="(i)"> <text>A 4-year, college-level degree;</text> </paragraph> <paragraph num="(ii)"> <text>Two years of experience in a healthcare related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or</text> </paragraph> <paragraph num="(iii)"> <text>Two years of experience in a healthcare related field and successful completion of an 80-hour assisted living manager training course approved by the Department;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Completed an 80-hour assisted living manager training course and passed the course examination as required under Health–General Article, §19–1807(a), Annotated Code of Maryland, and Health Occupations Article, §9-3A-02(a)(5)(i), Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submit the following to the Board:</text> <paragraph num="(a)"> <text>The completed Board online application;</text> </paragraph> <paragraph num="(b)"> <text>The application fee as set forth in COMAR 10.33.05.02D; and</text> </paragraph> <paragraph num="(c)"> <text>A passport type and size photograph of self, which shall have been taken within 3 months prior to the date of application;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Meet, and attest on the application to meeting, the following requirements:</text> <paragraph num="(a)"> <text>Submitted to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is certified in:</text> <paragraph num="(i)"> <text>Basic first aid taught by a first aid instructor certified by a national organization, except licensed practical nurses and registered nurses licensed in this State who are not required to attest to being certified in basic first aid; and</text> </paragraph> <paragraph num="(ii)"> <text>Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Completed training in:</text> <paragraph num="(i)"> <text>Fire and life safety;</text> </paragraph> <paragraph num="(ii)"> <text>Infection control, including standard precautions;</text> </paragraph> <paragraph num="(iii)"> <text>Emergency disaster plans; and</text> </paragraph> <paragraph num="(iv)"> <text>Basic food safety.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-3A-03(3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Board may require official transcripts of the educational requirements set forth in §B(3) of this regulation.</text> </paragraph> <paragraph num="E."> <text>Exemptions for the 80-Hour Training Course. Except as otherwise provided by law, an applicant is exempt from the 80-hour training course, pursuant to Health–General Article, §19–1807(d)(1), Annotated Code of Maryland, if the applicant meets, and attests to meeting, at least one of the following:</text> <paragraph num="(1)"> <text>Is employed by an assisted living program and has enrolled in the 80-hour training course and expects to complete the course within 6 months; or</text> </paragraph> <paragraph num="(2)"> <text>Is licensed as a nursing home administrator in the State.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If an individual is licensed through the exemption in §E(1) of this regulation, the licensee shall:</text> <paragraph num="(1)"> <text>Complete the 80-hour course, which includes passing the course examination, within 6 months of enrollment in the course, in accordance with COMAR 10.07.14.16E(1); and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board satisfactory evidence that the licensee has completed the course, within 15 days from the date the licensee was notified of their successful completion of the course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Provisional License."> <paragraph num="A."> <text>As an exception to the licensure requirements in this chapter, an assisted living program shall immediately appoint an individual not licensed to practice as an assisted living manager to act as the interim assisted living manager if:</text> <paragraph num="(1)"> <text>An assisted living manager licensed in the State leaves or is removed from the position as an assisted living manager by death or other unexpected cause; and</text> </paragraph> <paragraph num="(2)"> <text>A licensed assisted living manager in the State is unavailable to fill the position.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The alternate assisted living manager is a non-licensed individual in this regulation and may be appointed as the interim assisted living manager under §A of this regulation, but another non-licensed individual may also be appointed.</text> </paragraph> <paragraph num="C."> <text>The departure of the assisted living manager as specified in §A of this regulation, is by unexpected cause if:</text> <paragraph num="(1)"> <text>The departure occurred suddenly;</text> </paragraph> <paragraph num="(2)"> <text>The departure was unforeseen; and</text> </paragraph> <paragraph num="(3)"> <text>There was insufficient time for the assisted living program to obtain the services of an assisted living manager licensed in the State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The appointed non-licensed individual may begin acting as the interim assisted living manager upon appointment.</text> </paragraph> <paragraph num="E."> <text>No later than 24 hours after the appointment of the non-licensed individual as interim assisted living manager, under §A of this regulation, the assisted living program shall:</text> <paragraph num="(1)"> <text>File an application with the Board requesting a provisional license for the non-licensed individual;</text> </paragraph> <paragraph num="(2)"> <text>Notify the Board of the circumstances involved in the departure of the licensed assisted living manager;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Board of the credentials of the non-licensed individual; and</text> </paragraph> <paragraph num="(4)"> <text>If requested, provide the Board with the actions the assisted living program took, or is taking, to hire an assisted living manager licensed in the State.</text> </paragraph> </paragraph> <paragraph num="F."> <text>State and National Criminal History Records Check. The appointed non-licensed individual shall immediately submit to a criminal history records check, in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland.</text> <paragraph num="(1)"> <text>A criminal history records check is not required if the appointed non-licensed individual is actively licensed by a health occupations board in the State who previously has completed a criminal history records check required for licensure, certification, or registration.</text> </paragraph> <paragraph num="(2)"> <text>The Board may deny approval of an appointment based on the results of a criminal history records check after consideration of the factors listed in Health Occupations Article, §9–3A–05(b)(1), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Provisional License. The Board may issue a provisional license to the applicant if the Board determines that:</text> <paragraph num="(1)"> <text>The applicant is of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>The departure of the licensed assisted living manager was by unexpected cause; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant is capable of adequately administering the assisted living program for the provisional period.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the Board grants the application for the provisional assisted living manager license, the provisional license is in effect for 90 days from the date of the departure of the licensed assisted living manager. For good cause shown, the Board may extend the provisional license period by 30 days.</text> </paragraph> <paragraph num="I."> <text>Denial of Provisional License.</text> <paragraph num="(1)"> <text>If the application for a provisional license is denied by the Board, the assisted living program may request a meeting with the Board to contest the denial.</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program shall provide the request for a meeting to the Board within 5 business days of the denial.</text> </paragraph> <paragraph num="(3)"> <text>If the assisted living program requests a meeting, the appointed non-licensed individual may remain acting as the interim assisted living manager until the Board issues a decision.</text> </paragraph> <paragraph num="(4)"> <text>If the assisted living program does not file a timely request for a meeting with the Board, the non-licensed individual shall cease acting as the interim assisted living manager after 5 days from the denial.</text> </paragraph> <paragraph num="(5)"> <text>If the Board denies the application for a provisional license after a meeting contesting the initial denial, the non-licensed individual shall cease acting as the interim assisted living manager upon receipt of the decision.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If the non-licensed individual is required to cease acting as the interim assisted living manager under §I(4) and (5) of this regulation, and an assisted living manager licensed in the State remains unavailable to fill the assisted living manager position, the assisted living program may appoint another non-licensed individual set forth in this regulation.</text> </paragraph> <paragraph num="K."> <text>As a result of §J of this regulation, if the assisted living program appoints another non-licensed individual, and a provisional license is granted, the provisional license is in effect for 90 days from the date of the departure of the assisted living manager licensed in the State, unless the Board extends the provisional license, for good cause, for an additional 30 days.</text> </paragraph> <paragraph num="L."> <text>Upon request by the assisted living program, for reasonable cause, the Board may extend the 24-hour time period for meeting the requirements of §E of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewals."> <paragraph num="A."> <text>A license expires on the second anniversary of its effective date, unless the license is renewed for a 2–year term as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>The Board shall send each licensee a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current license expires;</text> </paragraph> <paragraph num="(2)"> <text>Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee as specified in COMAR 10.33.05.02D.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least 30 days before the current license expires, the Board shall send the renewal notice by:</text> <paragraph num="(1)"> <text>Electronic means to the last known electronic mail address; or</text> </paragraph> <paragraph num="(2)"> <text>First-class mail to the physical address of the licensee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.07.14.16C.</text> </paragraph> <paragraph num="E."> <text>A licensee shall complete an implicit bias and structural racism training program approved by the Cultural and Linguistic Health Care Professional Competency Program in accordance with Health-General Article, §20-1306, Annotated Code of Maryland, for an applicant’s first renewal after April 1, 2026.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reinstatement After License Expiration."> <paragraph num="A."> <text>The Board shall reinstate an individual whose license has expired if the individual:</text> <paragraph num="(1)"> <text>Meets the renewal requirements of this chapter and Health Occupations Article, §9-3A-09, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Pays the reinstatement fee as specified under COMAR 10.33.05.02D; and</text> </paragraph> <paragraph num="(3)"> <text>Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.07.14.16C.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An assisted living manager who fails to apply for licensure reinstatement within 5 years after the expiration date of the license shall meet the requirements for a new license in effect at the time of the request in order to be licensed to practice as an assisted living manager in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Inactive Status and Reactivation."> <paragraph num="A."> <text>In accordance with Health Occupations Article, §9-3A-10, Annotated Code of Maryland, a request by an active licensee to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(1)"> <text>Completed Board-approved inactive status application; and</text> </paragraph> <paragraph num="(2)"> <text>Payment of the required, non-refundable, biennial inactive status fee set forth in COMAR 10.33.05.02D.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual:</text> <paragraph num="(1)"> <text>May apply for inactive status only if the individual’s license is still active at the time the inactive status application request is made;</text> </paragraph> <paragraph num="(2)"> <text>Shall renew and pay the biennial inactive status fee during each renewal period; and</text> </paragraph> <paragraph num="(3)"> <text>Is not authorized to and may not practice as an assisted living manager in the State while on inactive status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reactivation.</text> <paragraph num="(1)"> <text>The Board shall reactivate the license of a licensee who is on inactive status for less than 5 years if the licensee:</text> <paragraph num="(a)"> <text>Completes an application form for reactivation of the license before expiration of the 2–year term of inactive status on the form required by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Complies with the renewal requirements in effect at the time the licensee seeks to reactivate the license;</text> </paragraph> <paragraph num="(c)"> <text>Meets the continuing education requirements set by the Board under COMAR 10.33.04.02;</text> </paragraph> <paragraph num="(d)"> <text>Has not practiced as an assisted living manager in the State while on inactive status;</text> </paragraph> <paragraph num="(e)"> <text>Pays all appropriate fees set by the Board under COMAR 10.33.05.02D; and</text> </paragraph> <paragraph num="(f)"> <text>Is otherwise entitled to be licensed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before the Board may reactivate the license of an individual who has been on inactive status for 5 years or more, the individual shall:</text> <paragraph num="(a)"> <text>Submit a new online application;</text> </paragraph> <paragraph num="(b)"> <text>Pay all appropriate fees set by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Complete a Department-approved assisted living manager training course; and</text> </paragraph> <paragraph num="(d)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §9–3A-05, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An assisted living manager whose inactive status expires before the license is reactivated shall meet the reinstatement requirements of Health Occupations Article, §9–3A–09, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Incomplete Applications."> <paragraph num="A."> <text>The Board is not required to consider an application that is incomplete.</text> </paragraph> <paragraph num="B."> <text>The applicant shall submit to the Board any additional relevant documentation requested by the Board if the Board determines the application documentation received is incomplete or insufficient.</text> </paragraph> <paragraph num="C."> <text>The Board may hold an incomplete application for a license for up to 1 year from the date of receipt.</text> </paragraph> <paragraph num="D."> <text>After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.</text> </paragraph> <paragraph num="E."> <text>If an application has been closed under §D of this regulation, to obtain a license the applicant shall submit a new application fee and otherwise comply with all applicable license requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Display of License."> <text>Each individual licensed as an assisted living manager in the State shall display printed verification of licensure in a conspicuous place in the office or place of business or employment of the licensee.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Change of Mailing Address, Legal Name, or Email Address."> <paragraph num="A."> <text>A licensed assisted living manager shall give the Board written or electronic notice within 30 days of a change of:</text> <paragraph num="(1)"> <text>Mailing address;</text> </paragraph> <paragraph num="(2)"> <text>Legal name; or</text> </paragraph> <paragraph num="(3)"> <text>Email address.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fine as set forth under COMAR 10.33.05.02D.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-1809; Health Occupations Article, §§9-205, 9-3A-01—9-3A-18, and 9-401—9-501; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="04" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Continuing Education Requirements for Nursing Home Administrators."> <paragraph num="A."> <text>The approval of continuing education hours shall be at the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Before renewal, a nursing home administrator shall submit satisfactory evidence of having completed a minimum of 40 hours of Board approved continuing education, unless otherwise specified by State or federal law, within the 2-year period before the renewal date.</text> </paragraph> <paragraph num="C."> <text>The Board shall audit a percentage of nursing home administrators, to be determined by the Board, for each reporting period.</text> </paragraph> <paragraph num="D."> <text>On request by the Board, a nursing home administrator shall provide full documentation of the credit hours completed in accordance with the requirements of this regulation.</text> </paragraph> <paragraph num="E."> <text>All continuing education shall be completed in courses approved by NAB, except as provided in §§F and G of this regulation.</text> </paragraph> <paragraph num="F."> <text>The Board shall award 10 hours of continuing education for each completed college credit from an accredited institution that falls within the subjects outlined in COMAR 10.33.02.03A.</text> </paragraph> <paragraph num="G."> <text>The Board shall award 1 hour of continuing education for each month a preceptor serves as an instructor in an AIT program, up to a maximum of 12 credit hours per renewal cycle.</text> </paragraph> <paragraph num="H."> <text>A licensee suspended for disciplinary reasons is not exempt from the continuing education requirement in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Continuing Education Requirements for Assisted Living Managers."> <paragraph num="A."> <text>The approval of continuing education hours shall be at the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Before renewal, an assisted living manager shall submit satisfactory evidence of having completed a minimum of 20 hours of Department approved continuing education, unless otherwise specified by State or federal law, within the 2-year period before the renewal date.</text> </paragraph> <paragraph num="C."> <text>The Board shall audit a percentage of assisted living managers, to be determined by the Board, for each reporting period.</text> </paragraph> <paragraph num="D."> <text>On request by the Board, an assisted living manager shall provide full documentation of the credit hours completed in accordance with the requirements of this regulation.</text> </paragraph> <paragraph num="E."> <text>A licensee suspended for disciplinary reasons is not exempt from the continuing education requirement in this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-1807; Health Occupations Article, §§9-205 and 9-311; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="05" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all individuals licensed or applying for licensure by the Board under this subtitle.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>The fee for a license shall be established by the Board under this subtitle.</text> </paragraph> <paragraph num="B."> <text>The fee shall be payable on notification by the Board that the applicant has successfully completed the requirements for licensure or renewal.</text> </paragraph> <paragraph num="C."> <text>The license fee or license renewal fee does not include costs for participating in educational courses or for the examination.</text> </paragraph> <paragraph num="D."> <text>Fee Schedule.</text> <paragraph num="(1)"> <text>Initial application — $100.</text> </paragraph> <paragraph num="(2)"> <text>License fee — $200.</text> </paragraph> <paragraph num="(3)"> <text>Biennial license renewal — $200.</text> </paragraph> <paragraph num="(4)"> <text>Reinstatement fee — $300.</text> </paragraph> <paragraph num="(5)"> <text>Inactive status fee — $100.</text> </paragraph> <paragraph num="(6)"> <text>Biennial inactive renewal — $100.</text> </paragraph> <paragraph num="(7)"> <text>Reactivation fee — $200.</text> </paragraph> <paragraph num="(8)"> <text>Fine for failure to notify Board of change in either name, home address of the licensee, or email address, or change in name or address of the employer or business connection of the licensee within 30 days of the change — $100.</text> </paragraph> <paragraph num="(9)"> <text>NAB Examinations. The National Association of Long-Term Care Administrators Boards, Inc. determines the fees for the National Licensure Examination for nursing home administrators. A fee is charged each time an applicant takes an exam.</text> </paragraph> <paragraph num="(10)"> <text>State Standards Examination. The examination service determines the fee for the State standards exam. A fee is charged each time an applicant takes the exam.</text> </paragraph> </paragraph> <paragraph num="E."> <text>All fees are non-refundable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§9-205, 9-206, 9-311—9-312.1, 9-3A-03, and 9-3A-08—9-3A-10, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="06" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all licensees of the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Principles."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>In all professional relationships, be honest and practice with compassion and respect for the dignity and rights of the individual, with commitment to the care, safety, and well-being of the residents being paramount;</text> </paragraph> <paragraph num="(2)"> <text>Practice in a manner consistent with the laws and standards of practice pertaining to the nursing home or assisted living program the licensee administers or manages;</text> </paragraph> <paragraph num="(3)"> <text>Provide a safe and healthy environment which shall protect the rights of the residents;</text> </paragraph> <paragraph num="(4)"> <text>Promote and enhance their profession and its standards by increasing awareness and understanding of healthcare and their profession;</text> </paragraph> <paragraph num="(5)"> <text>Be responsible for maintaining their professional competence and to continue professional development and growth through continuing education; and</text> </paragraph> <paragraph num="(6)"> <text>Safeguard the confidentiality and privacy of information regarding residents consistent with existing law and professional standards.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee may not discriminate on the basis of race, color, sex, religion, age, national origin, disability, or other basis prohibited by State or federal law or regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§9-205, 9-314, and 9-3A-12, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="07" heading="Sanctions and Disciplinary Proceedings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern procedures for disciplinary and licensing proceedings before the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative prosecutor” means the attorney assigned from the Office of the Attorney General to prosecute the Board’s administrative charges on behalf of the State.</text> </paragraph> <paragraph num="(2)"> <text>“Charges” means the accusations or grounds for action that the Board alleges a respondent committed which concerns:</text> <paragraph num="(a)"> <text>A disciplinary action against a licensee that may result in sanctions against a licensee;</text> </paragraph> <paragraph num="(b)"> <text>Intent to deny an initial application for licensure;</text> </paragraph> <paragraph num="(c)"> <text>An action against an individual practicing nursing home administration or assisted living management without a license; or</text> </paragraph> <paragraph num="(d)"> <text>Other action authorized by law or regulation against an individual, licensee, or applicant that entitles the respondent to a contested case hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Charging document” means the document that includes the charges that initiates a Board action against a respondent and gives formal notice to the respondent of an action by the Board.</text> </paragraph> <paragraph num="(4)"> <text>Complaint.</text> <paragraph num="(a)"> <text>“Complaint” means an allegation or report received by the Board that indicates:</text> <paragraph num="(i)"> <text>A Board licensee may have committed an act or omission for which the licensee may be disciplined or sanctioned;</text> </paragraph> <paragraph num="(ii)"> <text>An applicant may have committed an act or omission that could result in the denial of the applicant’s application for a license; or</text> </paragraph> <paragraph num="(iii)"> <text>An individual may be practicing either nursing home administration or assisted living management without a license.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Complaint” may include, but is not limited to, the following:</text> <paragraph num="(i)"> <text>Consumer complaints and complaints from the public;</text> </paragraph> <paragraph num="(ii)"> <text>Reports or allegations from a government entity concerning a nursing home or assisted living program at which the licensee, applicant, or individual is or was employed;</text> </paragraph> <paragraph num="(iii)"> <text>Media reports;</text> </paragraph> <paragraph num="(iv)"> <text>Statements on Board applications for licensure;</text> </paragraph> <paragraph num="(v)"> <text>Reports from anonymous sources; or</text> </paragraph> <paragraph num="(vi)"> <text>Information from any source that warrants an investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Preliminary investigation” means a review of the allegations in a complaint by the Board and the response from a respondent, if sought and provided, that determines whether there is a sufficient basis for a formal Board investigation.</text> </paragraph> <paragraph num="(6)"> <text>“Respondent” means a licensee, applicant, or individual who:</text> <paragraph num="(a)"> <text>Is under investigation by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Has been charged by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Complaints, Investigations, and Disposition of Complaint."> <paragraph num="A."> <text>Complaint.</text> <paragraph num="(1)"> <text>Any person, government entity, public officer, association, or the Board may submit to the Board a complaint against any licensee, applicant, or individual for due cause.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall investigate and take appropriate action as to any complaint filed with the Board that alleges or indicates that:</text> <paragraph num="(a)"> <text>A licensee has failed to meet any standard governing the practice of the licensee’s profession;</text> </paragraph> <paragraph num="(b)"> <text>A licensee or an applicant has violated disciplinary grounds of the Board; or</text> </paragraph> <paragraph num="(c)"> <text>An unlicensed individual:</text> <paragraph num="(i)"> <text>Is practicing nursing home administration or assisted living management in this State without a license or proper authorization; or</text> </paragraph> <paragraph num="(ii)"> <text>Has represented to the public that the individual is authorized to practice nursing home administration or assisted living management in this State without a license or proper authorization from the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may investigate responses in a Board licensure application that may warrant denial of the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Representation by Counsel.</text> <paragraph num="(1)"> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="(2)"> <text>If the matter goes to a hearing, a respondent may be represented by:</text> <paragraph num="(a)"> <text>The respondent; or</text> </paragraph> <paragraph num="(b)"> <text>An attorney who is:</text> <paragraph num="(i)"> <text>Admitted to the Maryland Bar; or</text> </paragraph> <paragraph num="(ii)"> <text>Specially admitted to practice law pursuant to Maryland Rule 19-217.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>An administrative prosecutor assigned to the Board by the Office of the Attorney General shall prosecute disciplinary matters in Board proceedings.</text> </paragraph> <paragraph num="(4)"> <text>The Board may be represented by and obtain the advice of counsel assigned to it by the Office of the Attorney General in all proceedings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Confidentiality of Proceedings.</text> <paragraph num="(1)"> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Office of Administrative Hearings’ proceedings involving the adjudication of a Board-contested case and the administrative law judge's proposed decision are confidential. The parties may not waive the confidentiality of the proceedings or of the residents whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="(3)"> <text>Except as otherwise provided by law, even after a final decision is issued by the Board, the parties may not reveal the identity of any residents or patients referenced in the Board proceeding.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Investigation of Complaint.</text> <paragraph num="(1)"> <text>After receipt of a complaint, the Board staff:</text> <paragraph num="(a)"> <text>Shall send an acknowledgement to the complainant;</text> </paragraph> <paragraph num="(b)"> <text>Shall present the complaint to the disciplinary committee of the Board; and</text> </paragraph> <paragraph num="(c)"> <text>May forward the complaint to another regulatory agency that has jurisdiction over the matter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board's disciplinary committee shall:</text> <paragraph num="(a)"> <text>Review a complaint over which the Board has jurisdiction; and</text> </paragraph> <paragraph num="(b)"> <text>Make a recommendation to the Board on whether to open a formal investigation of a complaint. The disciplinary committee may recommend to the Board closure of the case based on a preliminary investigation of the complaint.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Prior to or after a decision on whether to open a formal investigation of a complaint, the Board may send a summary or a copy of the complaint, either in its entirety or redacted, to the licensee, applicant, or individual who is the subject of the complaint to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(4)"> <text>Participation in review of complaints made to the Board is not a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in the case.</text> </paragraph> <paragraph num="(5)"> <text>If the Board votes for a formal investigation, an investigator shall be assigned to the investigation.</text> </paragraph> <paragraph num="(6)"> <text>As part of its investigation, the Board may issue investigative subpoenas requiring attendance and testimony or the production of records or tangible objects. The subpoena shall be:</text> <paragraph num="(a)"> <text>Signed by:</text> <paragraph num="(i)"> <text>The Board’s Executive Director; or</text> </paragraph> <paragraph num="(ii)"> <text>A Board officer;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Served by:</text> <paragraph num="(i)"> <text>U.S. first-class mail;</text> </paragraph> <paragraph num="(ii)"> <text>Certified mail to the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(iii)"> <text>Hand delivery in-person or by courier;</text> </paragraph> <paragraph num="(iv)"> <text>Delivery service for which a signature is required;</text> </paragraph> <paragraph num="(v)"> <text>Electronic means; or</text> </paragraph> <paragraph num="(vi)"> <text>A method otherwise agreed to by the person or government entity to whom the subpoena is directed or the person’s counsel.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Subpoenas. If service of the subpoena is provided by electronic means, under §D(6)(b)(v) of this regulation, and no response or delivery receipt is obtained from the e-mail address to which service of the subpoena was provided, the Board shall serve the subpoena through other means under §D(6)(b) of this regulation.</text> </paragraph> <paragraph num="F."> <text>Except as otherwise provided by law, Board investigations are confidential.</text> </paragraph> <paragraph num="G."> <text>For each complaint, after a review of the complaint, pertinent investigative material, and the disciplinary committee’s recommendation, the Board shall:</text> <paragraph num="(1)"> <text>Close the case;</text> </paragraph> <paragraph num="(2)"> <text>Close the case with a nonpublic informal advisory letter to the licensee; or</text> </paragraph> <paragraph num="(3)"> <text>Vote to take any of the following actions:</text> <paragraph num="(a)"> <text>Charge the licensee with a violation or violations of Health Occupations Article, §§9-314 or 9-3A-12, Annotated Code of Maryland, or a violation or violations of Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Summarily suspend a license or issue a Notice of Intent to Summarily Suspend;</text> </paragraph> <paragraph num="(c)"> <text>Issue an intent to deny an application for licensure;</text> </paragraph> <paragraph num="(d)"> <text>Issue a cease and desist order; or</text> </paragraph> <paragraph num="(e)"> <text>Take any action against a respondent authorized by the subtitle or law that entitles the respondent to a contested case hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Referral to Prosecutor.</text> <paragraph num="(1)"> <text>After a vote for disciplinary action or actions, the matter shall be referred to an administrative prosecutor for prosecutorial action.</text> </paragraph> <paragraph num="(2)"> <text>After the administrative prosecutor has drafted the charging document, notice, or order of the disciplinary action or actions, if acceptable, a Board officer or the Board Executive Director shall sign the charging document, notice, or order of the disciplinary action or actions and the licensee, applicant, or individual shall be served.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Pre-Hearing Procedures."> <paragraph num="A."> <text>The charging document shall:</text> <paragraph num="(1)"> <text>Give reasonable notice of the Board’s action;</text> </paragraph> <paragraph num="(2)"> <text>Comply with State Government Article, §10-207, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Notify the respondent of, if applicable:</text> <paragraph num="(a)"> <text>Any proceedings scheduled before the Board and the consequences of failing to appear for those proceedings; and</text> </paragraph> <paragraph num="(b)"> <text>An opportunity to request a hearing within a certain period of time and the consequences of failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be accompanied by a letter of procedure notifying the respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the respondent does not participate in the Board proceeding without a valid reason, the Board may nevertheless proceed in adjudicating the case or issue a default order.</text> </paragraph> <paragraph num="C."> <text>If the Board initiates an investigation or if the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> <paragraph num="D."> <text>A notice of denial of a provisional license does not entitle the applicant, nursing home, or assisted living program to a hearing under this chapter.</text> </paragraph> <paragraph num="E."> <text>After the administrative prosecutor has drafted the charging document, if acceptable, a Board officer or the Board Executive Director shall sign the charging document.</text> </paragraph> <paragraph num="F."> <text>An investigation and prosecution of charges may proceed if a respondent's license expires after a Board investigation has been initiated or charges have been issued.</text> </paragraph> <paragraph num="G."> <text>Service of the Charging Document. If the Board issues a charging document, the charging document shall be served upon the respondent at the address the respondent maintains for purposes of licensure or the respondent’s last known address by:</text> <paragraph num="(1)"> <text>U.S. first-class mail;</text> </paragraph> <paragraph num="(2)"> <text>Certified mail;</text> </paragraph> <paragraph num="(3)"> <text>Hand delivery in person or by courier;</text> </paragraph> <paragraph num="(4)"> <text>Delivery service for which a signature is required;</text> </paragraph> <paragraph num="(5)"> <text>Electronic means; or</text> </paragraph> <paragraph num="(6)"> <text>A method otherwise agreed to by the respondent or respondent’s counsel.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If service of the charging document is provided by electronic means, under §G(5) of this regulation, and no response or delivery receipt is obtained from the e-mail address to which service of the charging document was provided, the Board shall serve the charging document through other means under §G of this regulation.</text> </paragraph> <paragraph num="I."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of the charging document or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are confidential and without prejudice and may not be used by the respondent, administrative prosecutor, or Board in any subsequent proceedings, unless the information is otherwise discovered or available by other appropriate means.</text> </paragraph> <paragraph num="(3)"> <text>Recommendations of the case resolution conference committee are not binding on the Board, which may:</text> <paragraph num="(a)"> <text>Accept the proposed resolution; or</text> </paragraph> <paragraph num="(b)"> <text>Modify a proposed settlement.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is proposed by the case resolution conference committee, or the Board, the matter shall proceed to a hearing on the charges.</text> </paragraph> <paragraph num="(5)"> <text>Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce copies of documents that the opposing party intends to be produced at the hearing within 30 days of service of the request.</text> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>At least 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier, each party shall provide to the other party:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Upon motion, if the Board Chair or the Board Chair’s designee, who shall be a Board member, or the Office of Administrative Hearings, as appropriate, finds that the expert report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, or the proposed expert is unqualified, the testimony of the expert and any report of the expert shall be excluded from the hearing.</text> </paragraph> <paragraph num="(c)"> <text>If an expert adopts a sufficiently specific charging document as the expert report, that adoption shall satisfy the requirements set forth in this section.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Motions and Orders for a Hearing Before the Board.</text> <paragraph num="(1)"> <text>Motions shall:</text> <paragraph num="(a)"> <text>Be in writing and filed with the Board and shall include the pertinent facts and legal authorities relied upon;</text> </paragraph> <paragraph num="(b)"> <text>Be decided by the Chair of the Board or the Chair’s designee, who shall be a Board member;</text> </paragraph> <paragraph num="(c)"> <text>Be served upon the opposing party’s legal counsel, if the opposing party is represented, and upon the opposing party, if not represented by legal counsel; and</text> </paragraph> <paragraph num="(d)"> <text>Contain a certificate of service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless shortened or extended by the presiding officer, the opposing party has 15 days from service of the motion to respond to the motion.</text> </paragraph> <paragraph num="(3)"> <text>Except as otherwise provided by this regulation, the Chair of the Board or the Chair’s designee, who shall be a Board member, may decide any issues needed to facilitate Board proceedings after the charging document is issued.</text> </paragraph> <paragraph num="(4)"> <text>Parties may be notified of decisions and orders from this chapter by the Board’s Executive Director, who may also sign decisions and orders on behalf of the Board or the Board decision maker.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Pre-Hearing Conference for Hearings Before the Board.</text> <paragraph num="(1)"> <text>The Board may hold a pre-hearing conference.</text> </paragraph> <paragraph num="(2)"> <text>If the Board holds a pre-hearing conference, at minimum:</text> <paragraph num="(a)"> <text>A Board member shall attend; and</text> </paragraph> <paragraph num="(b)"> <text>Both parties shall disclose any:</text> <paragraph num="(i)"> <text>Anticipated witnesses; and</text> </paragraph> <paragraph num="(ii)"> <text>Documents anticipated to be offered into evidence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(4)"> <text>The parties shall comply with the pre-hearing conference instructions and orders.</text> </paragraph> <paragraph num="(5)"> <text>In the case of unforeseen circumstances which would otherwise impose an extraordinary hardship on a party:</text> <paragraph num="(a)"> <text>If a prehearing conference is scheduled, witnesses or documents may not be added to the list after the prehearing conference; or</text> </paragraph> <paragraph num="(b)"> <text>If no prehearing conference is scheduled, witnesses or documents may not be added to the list later than 15 days before the hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Failure to comply with discovery, pre-hearing conference instructions, or orders may result in the exclusion of witnesses from testifying or documents from being admitted or default.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Hearings and Final Decisions."> <paragraph num="A."> <text>Hearings shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> <paragraph num="(1)"> <text>The Board may delegate the Board’s authority to hear contested cases to the Office of Administrative Hearings on a case-by-case basis.</text> </paragraph> <paragraph num="(2)"> <text>Proceedings are not open to the public.</text> </paragraph> <paragraph num="(3)"> <text>Hearings may be held by electronic means.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Burden of Proof. A party asserting the affirmative of an issue bears the burden of proof regarding the issue.</text> </paragraph> <paragraph num="C."> <text>Order of Procedure. The party with the burden of proof shall present their case first.</text> </paragraph> <paragraph num="D."> <text>Hearings Conducted Before the Board.</text> <paragraph num="(1)"> <text>The Board shall notify the parties of the date, time, and place of the hearing.</text> </paragraph> <paragraph num="(2)"> <text>Each hearing shall be held before a majority of the Board.</text> </paragraph> <paragraph num="(3)"> <text>The delegation for an evidentiary hearing to an administrative law judge shall be by the Board at its discretion.</text> </paragraph> <paragraph num="(4)"> <text>Presiding Officer. For hearings before the Board, the Board Chair, or, in the Chair's absence, a member designated by the Chair shall be the presiding officer of the hearing. The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing proceedings;</text> </paragraph> <paragraph num="(b)"> <text>Rule on any matter to facilitate the hearing;</text> </paragraph> <paragraph num="(c)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence;</text> </paragraph> <paragraph num="(e)"> <text>Admit evidence; and</text> </paragraph> <paragraph num="(f)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The presiding officer, at the presiding officer's discretion, may set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(6)"> <text>The presiding officer shall be responsible for decorum in a hearing and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> <paragraph num="(7)"> <text>Legal Advisor and Counsel for the Board. A representative of the Office of the Attorney General shall act as legal advisor and counsel to the Board.</text> </paragraph> <paragraph num="(8)"> <text>Administrative Prosecutor.</text> <paragraph num="(a)"> <text>The Board may request the Office of the Attorney General, Health Occupations and Prosecution Unit to participate as the administrative prosecutor in any hearing to present the case on behalf of the State.</text> </paragraph> <paragraph num="(b)"> <text>The administrative prosecutor that presents the case on behalf of the State shall have the same rights with regard to the submission of evidence, examination, cross-examination of witnesses, presentation of summation and argument, and filing of objections, exceptions, and motions as does the respondent and respondent’s counsel for any party.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(a)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §10-213, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Every party has the right to call witnesses and present evidence, cross-examine every witness called on behalf of the Board or other party, and present summation and argument and file objections, exceptions, and motions.</text> </paragraph> <paragraph num="(c)"> <text>When a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel.</text> </paragraph> <paragraph num="(d)"> <text>The presiding officer, or any person designated by the presiding officer for that purpose, may examine any witness called to testify. Any member of the Board may examine any witness called to testify.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Evidentiary Hearings Conducted at the Office of Administrative Hearings.</text> <paragraph num="(1)"> <text>Unless specified otherwise in this chapter, hearings delegated to the Office of Administrative Hearings are governed by the Office of Administrative Hearings Rules of Procedure, pursuant to COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>Proceedings are not open to the public.</text> </paragraph> <paragraph num="(3)"> <text>The Board action concerning charges against a nursing home administrator or an assisted living manager may be consolidated for the evidentiary hearing at the Office of Administrative Hearings, with a disciplinary action against a nursing home or assisted living program, brought by the Department if:</text> <paragraph num="(a)"> <text>The licensed nursing home administrator or licensed assisted living manager of the Board action administered or managed the facility that is the subject of the Department’s action; and</text> </paragraph> <paragraph num="(b)"> <text>The issues and facts in the cases are sufficiently similar.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a matter has been delegated to the Office of Administrative Hearings, unless otherwise specified by the Board, the administrative law judge presiding over the proceedings shall issue to the Board a proposed decision which shall include:</text> <paragraph num="(a)"> <text>Proposed findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed conclusions of law; and</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings or to an individual member of the Board, a party may file exceptions to the proposed decision before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise permitted by the Board, within 21 days after the issuance of the proposed decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party’s written exceptions may not be longer than 25 double-spaced pages and shall state with particularity the:</text> <paragraph num="(a)"> <text>Finding of fact;</text> </paragraph> <paragraph num="(b)"> <text>Conclusion of law or other matter excepted to; and</text> </paragraph> <paragraph num="(c)"> <text>Relevant portions of the record supporting the party’s exception.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Unless otherwise permitted by the Board, within 15 business days after a party’s exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party’s answer to exceptions may not be longer than 25 double-spaced pages and shall state with particularity:</text> <paragraph num="(a)"> <text>A response to an exception; and</text> </paragraph> <paragraph num="(b)"> <text>The relevant portions of the record supporting that response.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Unless otherwise agreed to by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties’ exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the exceptions hearing.</text> </paragraph> <paragraph num="(e)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes to present oral argument per side, unless approved by the presiding officer.</text> </paragraph> <paragraph num="(f)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Unless otherwise agreed to by the parties and permitted by the Board, in an answer to exceptions or in the hearing on exceptions, the parties may not reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(9)"> <text>If neither party files exceptions within the time specified in §C(2) of this regulation, in making the Board's final decision, the Board shall consider only the:</text> <paragraph num="(a)"> <text>Proposed decision of the administrative law judge; and</text> </paragraph> <paragraph num="(b)"> <text>Record of the evidentiary hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Final Decision. After a formal hearing is conducted, the Board shall issue a written final decision to be sent to the parties upon issuance which shall include:</text> <paragraph num="(1)"> <text>Findings of fact;</text> </paragraph> <paragraph num="(2)"> <text>Conclusions of law;</text> </paragraph> <paragraph num="(3)"> <text>An order; and</text> </paragraph> <paragraph num="(4)"> <text>Appeal rights, if applicable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Grounds for Sanctioning and Sanctions."> <paragraph num="A."> <text>The Board may deny a license to any applicant, suspend or revoke the license of a licensee, place on probation, reprimand, or fine a licensee after proper notice and a hearing, if the applicant or licensee:</text> <paragraph num="(1)"> <text>Violated any of the provisions of law or regulations pertaining to the licensing or practice of nursing home administration or assisted living management;</text> </paragraph> <paragraph num="(2)"> <text>Violated any of the provisions of the law or regulations of the:</text> <paragraph num="(a)"> <text>Licensing or oversight authority or agency of the State for nursing homes or assisted living programs; or</text> </paragraph> <paragraph num="(b)"> <text>Federal entity having jurisdiction over the operation of nursing homes;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Is incompetent to engage in the practice of nursing home administration or assisted living management or to act as a nursing home administrator or assisted living manager;</text> </paragraph> <paragraph num="(4)"> <text>Engaged in fraud, deceit, or misrepresentation in the licensee’s or applicant’s capacity as a nursing home administrator or assisted living manager;</text> </paragraph> <paragraph num="(5)"> <text>Wrongfully transferred or surrendered possession of, either temporarily or permanently, an individual’s license;</text> </paragraph> <paragraph num="(6)"> <text>Paid, gave, caused to be paid or given, or offered to pay or be given to any person a commission or other valuable consideration for the solicitation or procurement, either directly or indirectly, of nursing home or assisted living program patronage;</text> </paragraph> <paragraph num="(7)"> <text>Used fraudulent, misleading, or deceptive advertising;</text> </paragraph> <paragraph num="(8)"> <text>Falsely impersonated another licensee;</text> </paragraph> <paragraph num="(9)"> <text>Endangered or sanctioned the endangerment of the safety, health, or life of any resident of a nursing home or assisted living program;</text> </paragraph> <paragraph num="(10)"> <text>Violated a resident’s rights or allowed a resident’s rights to be violated;</text> </paragraph> <paragraph num="(11)"> <text>Failed to oversee and facilitate the nursing home’s or assisted living program’s quality improvement processes to the extent that the safety, health, or life of any resident has been endangered;</text> </paragraph> <paragraph num="(12)"> <text>Willfully permitted the unauthorized disclosure of information relating to a resident or the resident’s records;</text> </paragraph> <paragraph num="(13)"> <text>Discriminated against residents, employees, or staff on account of race, religion, national origin, sexual orientation, or disability;</text> </paragraph> <paragraph num="(14)"> <text>Violated the Code of Ethics set forth under COMAR 10.33.06;</text> </paragraph> <paragraph num="(15)"> <text>Engaged in sexual behavior that would be considered unethical or unprofessional according to professional standards of conduct, including, but not limited to:</text> <paragraph num="(a)"> <text>Sexual behavior with a resident or patient in the context of a professional evaluation, treatment, procedure, or service to the resident or patient, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(b)"> <text>Sexual behavior with a resident or patient under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(c)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a resident or patient;</text> </paragraph> <paragraph num="(d)"> <text>Sexual advances requesting sexual favors;</text> </paragraph> <paragraph num="(e)"> <text>Therapeutically inappropriate or intentional touching of a sexual nature;</text> </paragraph> <paragraph num="(f)"> <text>A verbal comment of a sexual nature;</text> </paragraph> <paragraph num="(g)"> <text>Physical contact of a sexual nature with a resident or patient;</text> </paragraph> <paragraph num="(h)"> <text>Discussion of unnecessary sexual matters with a resident or patient;</text> </paragraph> <paragraph num="(i)"> <text>Direct or indirect observation of a resident or patient while the resident or patient is undressing or dressing;</text> </paragraph> <paragraph num="(j)"> <text>Taking photographs or video of a resident or patient for a sexual purpose;</text> </paragraph> <paragraph num="(k)"> <text>Sexual harassment of staff, students, or volunteers;</text> </paragraph> <paragraph num="(l)"> <text>An unnecessary sensual act or comment;</text> </paragraph> <paragraph num="(m)"> <text>Sexual contact with an incompetent or unconscious client, patient, or resident; or</text> </paragraph> <paragraph num="(n)"> <text>Offering to provide services or material in exchange for sexual favors;</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Practiced as a nursing home administrator or assistant living manager in the State without a license from the Board or without proper authorization to practice as a nursing home administrator or assistant living manager;</text> </paragraph> <paragraph num="(17)"> <text>Falsified continuing education records; or</text> </paragraph> <paragraph num="(18)"> <text>Failed to cooperate with an investigation, proceedings, or other requirements of the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may, after due notice and an opportunity to be heard, suspend or revoke an AIT’s participation in a Board-approved AIT program, upon substantial evidence that the AIT has committed any of the actions listed in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>A licensee shall notify the Board in writing within 30 days if the licensee has been sanctioned by a licensing authority of another state for the practice as a nursing home administrator or assistant living manager.</text> </paragraph> <paragraph num="D."> <text>On finding that there has been a violation of Health Occupations Article, Title 9, Annotated Code of Maryland, or this subtitle, and in accordance with the applicable notice and due process procedures, the Board may order that the:</text> <paragraph num="(1)"> <text>Licensee be fined;</text> </paragraph> <paragraph num="(2)"> <text>Licensee be reprimanded;</text> </paragraph> <paragraph num="(3)"> <text>Licensee be placed on probation with appropriate terms and conditions;</text> </paragraph> <paragraph num="(4)"> <text>Licensee’s license be suspended, with or without terms and conditions; or</text> </paragraph> <paragraph num="(5)"> <text>Licensee’s license be revoked.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may order any of the sanctions listed in §A of this regulation in combination or individually as appropriate for the violations committed by the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>If the Board concludes that a licensee has violated a ground for discipline under Health Occupations Article, §§9-314(b) or 9-3A-12(b), Annotated Code of Maryland, or under this chapter, the Board shall:</text> <paragraph num="(1)"> <text>Determine the applicable sanction range according to the guidelines set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Consider the applicable aggravating and mitigating factors set forth in §J of this regulation to determine whether the sanction should fall outside the indicated range of sanctions; and</text> </paragraph> <paragraph num="(3)"> <text>After considering any applicable aggravating and mitigating factors, impose the appropriate sanction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines.</text> </paragraph> <paragraph num="C."> <text>In the event that a licensee’s violation of the Board’s statutes or regulation does not fall within a sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and consider, to the extent possible, the factors in the sanctioning guidelines.</text> </paragraph> <paragraph num="D."> <text>If the Board deviates from the sanctioning guidelines, the Board shall state its reasons for the deviation.</text> </paragraph> <paragraph num="E."> <text>A departure from the sanctioning guidelines is not an independent ground for an appeal or challenge of a Board action.</text> </paragraph> <paragraph num="F."> <text>Notwithstanding this regulation, in order to resolve a disciplinary proceeding, the Board and the licensee may agree to a surrender of license or a Consent Order with terms and sanction agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="G."> <text>In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation.</text> </paragraph> <paragraph num="H."> <text>If probation or suspension is imposed, the Board may impose appropriate terms and conditions for the probation or suspension. If a licensee violates the terms or conditions of the probation or suspension, the Board may take further disciplinary action against the licensee, as provided in the Board order.</text> </paragraph> <paragraph num="I."> <text>Pursuant to Health Occupations Article, §§9-314.1 and 9-3A-13, Annotated Code of Maryland, if a civil fine is imposed, the fine may not exceed $1,000 for a first violation or $5,000 for any subsequent violation of the same provision.</text> </paragraph> <paragraph num="J."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Mitigating Factors. In determining whether the sanction falls outside the indicated range of sanctions guidelines listed in Regulation .08 of this chapter, the Board may consider the following mitigating factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>That the licensee reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>That the licensee:</text> <paragraph num="(i)"> <text>Voluntarily admitted violation;</text> </paragraph> <paragraph num="(ii)"> <text>Provided full disclosure to the Board; and</text> </paragraph> <paragraph num="(iii)"> <text>Cooperated during Board proceedings;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>That the licensee implemented remedial measures to correct or mitigate harm arising from the violation;</text> </paragraph> <paragraph num="(e)"> <text>That the licensee made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of the licensee’s rehabilitation or potential for rehabilitation;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the violation;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to or adverse impact on the public;</text> </paragraph> <paragraph num="(i)"> <text>That the incident was isolated and is not likely to recur; or</text> </paragraph> <paragraph num="(j)"> <text>If the licensee has worked at the nursing home or assisted living program for a limited period, and the violation was present before beginning work at the facility or program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating Factors. In determining whether the sanction of the licensee falls outside the indicated range of sanctions guidelines listed in Regulation .08 of this chapter, the Board may consider the following aggravating factors:</text> <paragraph num="(a)"> <text>The licensee’s previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>If the violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>If the violation had the potential for, or caused, serious resident harm;</text> </paragraph> <paragraph num="(d)"> <text>If the violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>If the licensee pursued the licensee’s financial gain over a resident’s welfare;</text> </paragraph> <paragraph num="(f)"> <text>That the resident was especially vulnerable;</text> </paragraph> <paragraph num="(g)"> <text>That the licensee attempted to:</text> <paragraph num="(i)"> <text>Conceal the violation;</text> </paragraph> <paragraph num="(ii)"> <text>Falsify or destroy evidence; or</text> </paragraph> <paragraph num="(iii)"> <text>Present false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>That the licensee failed to cooperate with the Board’s investigation; or</text> </paragraph> <paragraph num="(i)"> <text>That the licensee’s previous attempts at rehabilitation were unsuccessful.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Guidelines for Disciplinary Sanctions."> <paragraph num="A."> <text>Patient Safety.</text> </paragraph> <paragraph num="B."> <text>Fraud, Deceit, or Misrepresentation.</text> </paragraph> <paragraph num="C."> <text>General Misconduct.</text> </paragraph> <paragraph num="D."> <text>Records Violation Without Fraudulent or Deceitful Intent.</text> </paragraph> <paragraph num="E."> <text>Administrator-In-Training Violations by Nursing Home Administrator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Surrender of License."> <paragraph num="A."> <text>This regulation pertains to the surrender of a license when:</text> <paragraph num="(1)"> <text>A licensee is under investigation by the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Charges have been issued by the Board against a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The surrender of a licensee’s license may be rejected by the Board.</text> </paragraph> <paragraph num="C."> <text>Letter of Surrender.</text> <paragraph num="(1)"> <text>The language of the Letter of Surrender is subject to the approval of the Board.</text> </paragraph> <paragraph num="(2)"> <text>If the Letter of Surrender is approved by the Board, it shall be signed by the respondent and the Board’s Executive Director.</text> </paragraph> <paragraph num="(3)"> <text>The Letter of Surrender may include, but is not limited to:</text> <paragraph num="(a)"> <text>The circumstances that resulted in the surrender;</text> </paragraph> <paragraph num="(b)"> <text>The time period before the respondent may apply for reinstatement if the surrender is not permanent; and</text> </paragraph> <paragraph num="(c)"> <text>Conditions before the respondent may apply for reinstatement.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Letter of Surrender is a final order that is the result of formal discipline, and a public document, under:</text> <paragraph num="(a)"> <text>General Provisions Article, §4-333, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, §1-607, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Summary Suspensions."> <paragraph num="A."> <text>Pursuant to its authority under State Government Article, §10-226(c), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that the public health, safety, or welfare imperatively requires emergency action against the licensee.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue a notice of intent to summarily suspend a license.</text> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact that the Board believes demonstrate that the public health, safety, or welfare imperatively requires emergency action against the licensee; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause as to why the Board should not execute the order of summary suspension, which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license no later than 5 days before a pre-deprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made as provided under COMAR 10.33.07.04G and H that includes proof of delivery.</text> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed to prosecute the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-Deprivation Opportunity to Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause as to why the respondent’s license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>Pre-Deprivation Show Cause Hearing Before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> <paragraph num="(f)"> <text>The presiding officer:</text> <paragraph num="(i)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious, if the presiding Board member believes that the documents or exhibits are necessary for a fair hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the presiding Board member in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Post-Deprivation Opportunity to be Heard.</text> <paragraph num="(1)"> <text>Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend a license or providing a respondent with an opportunity for a pre-deprivation hearing if the Board determines that:</text> <paragraph num="(a)"> <text>The public health, safety, or welfare imperatively requires the immediate suspension of the license; and</text> </paragraph> <paragraph num="(b)"> <text>Prior notice and an opportunity to be heard are not feasible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Time — Service and Hearing.</text> <paragraph num="(a)"> <text>An order of summary suspension under §D(1) of this regulation shall be served on the respondent promptly after its execution as provided by COMAR 10.33.07.04G and H that includes proof of delivery.</text> </paragraph> <paragraph num="(b)"> <text>The respondent shall be provided an opportunity for a post-deprivation hearing before the Board within 15 days after the effective date of the summary suspension, which shall provide the respondent with an opportunity to show cause as to why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall:</text> <paragraph num="(a)"> <text>Be conducted before the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the respondent with an opportunity to show cause as to why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare does not imperatively require the immediate suspension of a license.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent’s license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension; or</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed to by the parties.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Terminate or rescind the order for summary suspension; or</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed to by the parties.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under General Provisions Article, §4-333, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Post-Deprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license under §§C or D of this regulation, the respondent shall have an opportunity for an evidentiary hearing before the Board, or, if the Board delegates the matter to the Office of Administrative Hearings, before an administrative law judge.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts which form the basis for the summary suspension.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>If the Board delegates the matter to the Office of Administrative Hearings, unless otherwise specified by the Board, the administrative law judge shall issue a proposed decision to the Board with:</text> <paragraph num="(a)"> <text>Proposed findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed conclusions of law; and</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the hearing is one combined with charges, and the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge’s determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension.</text> </paragraph> <paragraph num="(7)"> <text>The parties may file exceptions to the proposed decision, as provided in State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>An order issued by the Board after a pre-deprivation or post-deprivation hearing is a public record under:</text> <paragraph num="(a)"> <text>Health Occupations Article, §1-607, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>General Provisions Article, §4-333, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Cease and Desist Orders."> <paragraph num="A."> <text>The Board may issue a cease and desist order to an unlicensed individual practicing nursing home administration or assisted living management without a license or authorization from the Board.</text> </paragraph> <paragraph num="B."> <text>The cease and desist order shall be served upon the respondent as provided by COMAR 10.33.07.04G and H that includes proof of delivery.</text> </paragraph> <paragraph num="C."> <text>The respondent is entitled to a prompt opportunity to be heard by the Board to contest the cease and desist order. This opportunity to be heard shall be conducted by argument and record evidence, without witness testimony.</text> </paragraph> <paragraph num="D."> <text>If the Board upholds the cease and desist order under §C of this regulation, if requested, the respondent shall be entitled to an evidentiary hearing pursuant to the procedures under Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Show Cause Hearings."> <paragraph num="A."> <text>The Board may conduct a show cause hearing to determine whether a respondent violated an order of the Board.</text> </paragraph> <paragraph num="B."> <text>An order of the Board includes, but is not limited to:</text> <paragraph num="(1)"> <text>Final decisions and orders;</text> </paragraph> <paragraph num="(2)"> <text>Consent orders; or</text> </paragraph> <paragraph num="(3)"> <text>Any order imposing probation, suspension, or another term or condition that the respondent is required to comply with.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Failure to comply with any term or condition of an order of the Board is a violation of the order of the Board.</text> </paragraph> <paragraph num="D."> <text>Service of the show cause order shall be as provided by COMAR 10.33.07.04G and H.</text> </paragraph> <paragraph num="E."> <text>If the Board determines there is no genuine dispute of material facts that cannot be resolved at the show cause hearing, the show cause hearing may be conducted by argument by the parties and records offered for consideration by the Board.</text> </paragraph> <paragraph num="F."> <text>The Board, in its discretion, may allow for an evidentiary hearing if it determines there is a genuine dispute of material fact that cannot be resolved at the show cause hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Petitions for Reinstatement Following License Revocation or Surrender."> <paragraph num="A."> <text>In order for a revoked or surrendered license to be reinstated, the individual whose license was revoked or surrendered shall petition the Board for reinstatement.</text> </paragraph> <paragraph num="B."> <text>A surrendered license in this regulation means a surrender, approved by the Board, while the individual was licensed and under investigation or charges had been issued by the Board.</text> </paragraph> <paragraph num="C."> <text>An individual who petitions the Board for reinstatement following the revocation or surrender of the individual’s license may petition for reinstatement only pursuant to the terms of the Board’s order revoking the license or the Letter of Surrender. The Board may set conditions precedent and a time period for petitioning for reinstatement or may permanently revoke or require permanent surrender.</text> </paragraph> <paragraph num="D."> <text>If the Board’s order revoking the license or the Letter of Surrender does not contain a time period for petitioning for reinstatement, the individual may petition for reinstatement after 3 years from revocation.</text> </paragraph> <paragraph num="E."> <text>A petitioner for reinstatement shall comply with all reasonable requests for information by the Board.</text> </paragraph> <paragraph num="F."> <text>The decision of the Board on whether to grant or deny the petition for reinstatement is a discretionary decision by the Board.</text> </paragraph> <paragraph num="G."> <text>If the Board denies a petition for reinstatement, the Board may set conditions precedent and a time period for further petitions for reinstatement.</text> </paragraph> <paragraph num="H."> <text>If the Board grants reinstatement, the Board may impose probationary conditions and restrictions along with the reinstatement.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104 and 19-1809; Health Occupations Article, §§1-212, 1-602—1-609, 9-205, 9-313—9-316.1, 9-3A-11—9-3A-17, and 9-401—9-407; State Government Article, §§10-201—10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> <chapter num="08" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The Board’s Executive Director may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, whether or not there has been a request for the information and may disclose the information under the following circumstances:</text> <paragraph num="A."> <text>The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>The information concerns a possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the person or government entity whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>The information concerns conduct by a person or government entity which the Board’s Executive Director reasonably believes may pose a risk to the public health, safety, or welfare and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other healthcare facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §9-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R 22)</annotation> </annotations> </chapter> </subtitle> <subtitle num="34" heading="Board of Pharmacy"> <chapter num="01" heading="Disciplinary Proceedings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case that the Board has delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges issued by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(4)"> <text>“Case resolution conference” means a voluntary, informal, and confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference committee” means a committee comprised of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(6)"> <text>“Cease and desist letter” means a public letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A registrant or licensee to cease doing a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed person to cease the unauthorized practice of pharmacy or the unauthorized operation of a pharmacy.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Charges” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a registrant or licensee that the Board believes constitutes a violation under the Maryland Pharmacy Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth sections of the Maryland Pharmacy Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the registrant or licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Complaint” means an allegation received by the Board that a registrant or licensee may have violated the Maryland Pharmacy Act, and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(9)"> <text>“Consent order” means a final order issued by the Board that has been negotiated and agreed to by both the registrant or licensee and the Board to resolve a formal disciplinary action.</text> </paragraph> <paragraph num="(10)"> <text>“Contested case” means a proceeding conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(11)"> <text>“Final order” means a public record issued by the Board resolving a formal disciplinary action by consent or after an adjudication, which:</text> <paragraph num="(a)"> <text>Denies a registration or license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by:</text> <paragraph num="(i)"> <text>Reprimand;</text> </paragraph> <paragraph num="(ii)"> <text>Probation;</text> </paragraph> <paragraph num="(iii)"> <text>Fine; or</text> </paragraph> <paragraph num="(iv)"> <text>Suspension or revocation of a registration or license;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a registration or license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a registration or license;</text> </paragraph> <paragraph num="(f)"> <text>Resolves the contested case by consent of the parties; or</text> </paragraph> <paragraph num="(g)"> <text>Takes any other action that the Board may take by law.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Formal disciplinary action” means action taken by the Board that:</text> <paragraph num="(a)"> <text>Is initiated by:</text> <paragraph num="(i)"> <text>Charges; or</text> </paragraph> <paragraph num="(ii)"> <text>A notice of initial denial;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is resolved by a consent order;</text> </paragraph> <paragraph num="(c)"> <text>Results in a summary suspension; or</text> </paragraph> <paragraph num="(d)"> <text>Results in a letter of surrender.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Informal action” means that the Board closes a case, without formal disciplinary action or issuing a final order, by sending a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment; or</text> </paragraph> <paragraph num="(c)"> <text>Letter of agreement.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Letter of admonishment” means an informal action taken by the Board consisting of a nonpublic letter closing the case if the Board believes a registrant or licensee engaged in conduct that violated the Maryland Pharmacy Act and may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions instead of the Board issuing charges.</text> </paragraph> <paragraph num="(15)"> <text>Letter of Education.</text> <paragraph num="(a)"> <text>“Letter of education” means an informal action consisting of a nonpublic letter:</text> <paragraph num="(i)"> <text>Issued by the Board, closing the case if the Board does not believe that the registrant's or licensee's conduct rose to the level of a violation of the Maryland Pharmacy Act; and</text> </paragraph> <paragraph num="(ii)"> <text>In which the Board educates the registrant or licensee regarding the laws and standards of the practice of pharmacy or operating a pharmacy.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Letter of education” may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public record accepted by the Board in which:</text> <paragraph num="(i)"> <text>The licensee agrees to surrender the licensee's license or permit; or</text> </paragraph> <paragraph num="(ii)"> <text>The registrant agrees to surrender the registrant's registration.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Licensee” means the holder of a license or permit issued by the Board.</text> </paragraph> <paragraph num="(18)"> <text>“Maryland Pharmacy Act” means Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant, registrant, or licensee is notified that the Board intends to:</text> <paragraph num="(a)"> <text>Change a registration or licensure status;</text> </paragraph> <paragraph num="(b)"> <text>Deny a registration, license, or permit; or</text> </paragraph> <paragraph num="(c)"> <text>Deny some other benefit sought by the registrant or licensee.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Party” means the:</text> <paragraph num="(a)"> <text>Respondent or person named or admitted as a party, or properly seeking and entitled as a right to be a party in a formal disciplinary proceeding; or</text> </paragraph> <paragraph num="(b)"> <text>Administrative prosecutor from the Office of the Attorney General presenting a case on behalf of the Board.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Postdeprivation hearing” means a show cause or an evidentiary hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the registrant or licensee may challenge the Board's basis for issuing the order of summary suspension.</text> </paragraph> <paragraph num="(22)"> <text>“Predeprivation hearing” means a show cause hearing in which the registrant or licensee has an opportunity to demonstrate to the Board why the Board should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action that the Board may take.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Presiding officer” means the president of the Board or, in the president's absence, a Board member designated by the president, who:</text> <paragraph num="(a)"> <text>Conducts hearings before the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Issues prehearing orders.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Probation” means a sanction imposed by the Board in a public final order under which the registrant or licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions in order to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(26)"> <text>“Recommended decision” means a nonpublic record issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of these actions.</text> </paragraph> <paragraph num="(27)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in the case.</text> </paragraph> <paragraph num="(28)"> <text>“Registrant” means the holder of a:</text> <paragraph num="(a)"> <text>Pharmacy technician registration issued by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Pharmacy intern registration issued by the Board.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Respondent” means a registrant or licensee subject to the jurisdiction of the Board, who has been:</text> <paragraph num="(a)"> <text>Given formal notice of allegations concerning violations of the Maryland Pharmacy Act; and</text> </paragraph> <paragraph num="(b)"> <text>Notified as to the possible imposition of sanctions or a summary suspension.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Revocation” means the removal of a registrant's registration or licensee's license or permit.</text> </paragraph> <paragraph num="(31)"> <text>“Sanction” means an action by the Board which:</text> <paragraph num="(a)"> <text>Reprimands;</text> </paragraph> <paragraph num="(b)"> <text>Places on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fines; or</text> </paragraph> <paragraph num="(d)"> <text>Suspends or revokes a registration, license, or permit.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Show cause hearing” means a nonevidentiary hearing in which the registrant or licensee may demonstrate to the Board why the Board should not issue a proposed order or continue to take an action that the Board may take.</text> </paragraph> <paragraph num="(33)"> <text>“Summary suspension” means the indefinite suspension of a registration or license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes emergency action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(34)"> <text>“Suspension” means the temporary denial of the right to use a registration, license, or permit and is usually defined by:</text> <paragraph num="(a)"> <text>A specified period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings' proceedings involving the adjudication of a Board formal disciplinary action and the administrative law judge's recommended decision are confidential.</text> </paragraph> <paragraph num="C."> <text>The respondent may not waive the confidentiality of the:</text> <paragraph num="(1)"> <text>Proceedings; or</text> </paragraph> <paragraph num="(2)"> <text>Patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To the extent possible, even after the close of a formal disciplinary action, the parties shall refrain from revealing:</text> <paragraph num="(1)"> <text>Legal documents;</text> </paragraph> <paragraph num="(2)"> <text>Oral statements; or</text> </paragraph> <paragraph num="(3)"> <text>Information that would reveal the identity of patients involved in the matter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel at any stage of a formal disciplinary action.</text> </paragraph> <paragraph num="B."> <text>If a hearing is held on a matter, the respondent shall be represented:</text> <paragraph num="(1)"> <text>In proper person; or</text> </paragraph> <paragraph num="(2)"> <text>By an attorney who has been:</text> <paragraph num="(a)"> <text>Admitted to the Maryland Bar; or</text> </paragraph> <paragraph num="(b)"> <text>Specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may request the Office of the Attorney General to participate in a hearing to present the case on behalf of the State.</text> </paragraph> <paragraph num="D."> <text>The member of the Office of the Attorney General presenting the case on behalf of the State has the same rights as any party with regard to:</text> <paragraph num="(1)"> <text>Submission of evidence, examination, and cross-examination of witnesses; and</text> </paragraph> <paragraph num="(2)"> <text>The filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may request a member of the Office of the Attorney General to act as legal advisor to the Board on questions of:</text> <paragraph num="(1)"> <text>Procedure;</text> </paragraph> <paragraph num="(2)"> <text>Evidence; and</text> </paragraph> <paragraph num="(3)"> <text>Law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disposition of Complaints."> <paragraph num="A."> <text>For each complaint, after reviewing any completed investigative information or reports, the Board shall:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(3)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(4)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(5)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(6)"> <text>Vote to:</text> <paragraph num="(a)"> <text>Charge a registrant or licensee with a violation of the Maryland Pharmacy Act;</text> </paragraph> <paragraph num="(b)"> <text>Consider the matter as a basis for a summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Initially deny a registration, license, or permit or reinstatement of a registration, license, or permit; or</text> </paragraph> <paragraph num="(d)"> <text>Accept the surrender of a registration, license, or permit subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not the Board has voted to charge a registrant or licensee with violations of the Maryland Pharmacy Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Notice of Charges or Notice of Initial Denial."> <paragraph num="A."> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(1)"> <text>Served on the respondent by certified mail at the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Hand delivered in person.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Charges or notice of initial denial shall:</text> <paragraph num="(1)"> <text>Inform the respondent of the statutory basis for the charges or denial of a registration, license, or permit;</text> </paragraph> <paragraph num="(2)"> <text>Allege sufficient facts that the Board believes constitute a basis for:</text> <paragraph num="(a)"> <text>Violation of the Maryland Pharmacy Act; or</text> </paragraph> <paragraph num="(b)"> <text>Denial of a registration, license, or permit; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include the notice of hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board issues a notice of initial denial to an applicant for a registration or license, the applicant may not withdraw the application without approval from the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Notice of Hearing."> <paragraph num="A."> <text>Except for a show cause hearing, written notice of hearings shall be sent by the Executive Director or an officer of the Board to the parties at least 20 days before the hearing.</text> </paragraph> <paragraph num="B."> <text>The Board shall serve the notice of hearing by:</text> <paragraph num="(1)"> <text>Certified mail at the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Hand delivery in person.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice of hearing shall state, if applicable:</text> <paragraph num="(1)"> <text>The date, time, place, and nature of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>The right to:</text> <paragraph num="(a)"> <text>Representation;</text> </paragraph> <paragraph num="(b)"> <text>Call witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Submit documents or other relevant evidence;</text> </paragraph> <paragraph num="(d)"> <text>Request subpoenas for witnesses and evidence and the costs associated with such a request;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>That a failure to appear for the scheduled hearing may result in an adverse action against the party; and</text> </paragraph> <paragraph num="(4)"> <text>That the parties may agree to the evidence and waive their right to appear at the hearing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The notice of hearing may include:</text> <paragraph num="(1)"> <text>Deadlines for:</text> <paragraph num="(a)"> <text>Discovery; and</text> </paragraph> <paragraph num="(b)"> <text>Motions; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Dates for the:</text> <paragraph num="(a)"> <text>Prehearing conference; and</text> </paragraph> <paragraph num="(b)"> <text>Case resolution conference.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Prehearing Conferences and Case Resolution Conferences."> <paragraph num="A."> <text>The Board may set a prehearing conference or a case resolution conference, or both.</text> </paragraph> <paragraph num="B."> <text>The prehearing conference may be used to prepare for the hearing by:</text> <paragraph num="(1)"> <text>Delineating the issues;</text> </paragraph> <paragraph num="(2)"> <text>Stipulating to:</text> <paragraph num="(a)"> <text>Facts;</text> </paragraph> <paragraph num="(b)"> <text>Laws; and</text> </paragraph> <paragraph num="(c)"> <text>Other matters;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Arranging a schedule for the:</text> <paragraph num="(a)"> <text>Exchange of documents and witness information; and</text> </paragraph> <paragraph num="(b)"> <text>Submission of motions and responses to motions; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Addressing other matters that will promote the orderly and efficient conduct of the hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prehearing Orders.</text> <paragraph num="(1)"> <text>If a prehearing conference has been held, a prehearing order may be issued by the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The prehearing order shall set forth the actions taken or to be taken with regard to any matter addressed at the prehearing conference.</text> </paragraph> <paragraph num="(3)"> <text>If a prehearing conference is not held, the presiding officer may issue a prehearing order to regulate the conduct of the proceedings.</text> </paragraph> <paragraph num="(4)"> <text>Absent an exception from the presiding officer, the prehearing order shall be binding on the parties.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Case Resolution Conference.</text> <paragraph num="(1)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in subsequent proceedings, unless the information is otherwise discoverable or available through another source.</text> </paragraph> <paragraph num="(2)"> <text>The Board is not bound by the recommendations of the case resolution conference committee and may:</text> <paragraph num="(a)"> <text>Modify the proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing on the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(4)"> <text>Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Motions.</text> <paragraph num="(1)"> <text>Unless otherwise set forth in a prehearing order or notice of hearing, motions shall be:</text> <paragraph num="(a)"> <text>Accompanied by a memorandum of points and authorities; and</text> </paragraph> <paragraph num="(b)"> <text>Filed with the Board at least 15 working days before the hearing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A copy of a motion filed with the Board shall be served on the opposing party by the party filing the motion.</text> </paragraph> <paragraph num="(3)"> <text>A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party.</text> </paragraph> <paragraph num="(4)"> <text>The Board may refuse to consider a motion or response that is not timely filed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Discovery."> <paragraph num="A."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §A(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the:</text> <paragraph num="(i)"> <text>Opinion offered;</text> </paragraph> <paragraph num="(ii)"> <text>Factual basis for the opinion; and</text> </paragraph> <paragraph num="(iii)"> <text>Reasons underlying the opinion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §B(1) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §B(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Both parties have a continuing duty to supplement their disclosure of witnesses and documents.</text> </paragraph> <paragraph num="E."> <text>Absent unforeseen circumstances that would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="G."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Evidentiary Hearings."> <paragraph num="A."> <text>Hearings shall be conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="B."> <text>The Board may delegate its authority to conduct hearings to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>Hearings are not open to the public.</text> </paragraph> <paragraph num="D."> <text>Records, including the recommended decision, shall be treated as confidential and sealed.</text> </paragraph> <paragraph num="E."> <text>Records.</text> <paragraph num="(1)"> <text>The Board shall prepare an official record of hearings that shall include all:</text> <paragraph num="(a)"> <text>Pleadings;</text> </paragraph> <paragraph num="(b)"> <text>Testimony;</text> </paragraph> <paragraph num="(c)"> <text>Exhibits; and</text> </paragraph> <paragraph num="(d)"> <text>Other memoranda or material filed in the proceeding.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board.</text> </paragraph> <paragraph num="(3)"> <text>The stenographic record may not be transcribed, unless requested by a party or by the Board.</text> </paragraph> <paragraph num="(4)"> <text>The cost of transcribing all or part of a proceeding, shall be paid by the party requesting the typewritten transcript.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the members serving on the Board is a quorum of the Board.</text> </paragraph> <paragraph num="(2)"> <text>Hearings shall be held before a quorum of the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Presiding Officer.</text> <paragraph num="(1)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Conduct a full, fair, and impartial hearing;</text> </paragraph> <paragraph num="(b)"> <text>Take action to avoid unnecessary delay in the disposition of the proceedings;</text> </paragraph> <paragraph num="(c)"> <text>Maintain order; and</text> </paragraph> <paragraph num="(d)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The presiding officer may regulate the course of the hearing and the conduct of the parties, including the authority to:</text> <paragraph num="(a)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(b)"> <text>Rule on offers of proof and admit relevant and material evidence;</text> </paragraph> <paragraph num="(c)"> <text>Consider and rule on motions;</text> </paragraph> <paragraph num="(d)"> <text>Grant a continuance or postponement;</text> </paragraph> <paragraph num="(e)"> <text>Determine the order in which the parties shall present their cases;</text> </paragraph> <paragraph num="(f)"> <text>Limit unduly repetitious testimony;</text> </paragraph> <paragraph num="(g)"> <text>Reasonably limit the time for presentation; and</text> </paragraph> <paragraph num="(h)"> <text>Issue orders necessary to:</text> <paragraph num="(i)"> <text>Secure procedural simplicity and administrative fairness; and</text> </paragraph> <paragraph num="(ii)"> <text>Eliminate unjustifiable expense and delay.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in State Government Article, §10-213, Annotated Code of Maryland apply to hearings before the Board.</text> </paragraph> <paragraph num="(2)"> <text>A party may:</text> <paragraph num="(a)"> <text>Submit evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examine and cross-examine witnesses; and</text> </paragraph> <paragraph num="(c)"> <text>File objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a party is represented by counsel, submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by the counsel.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer, or a person designated by the presiding officer for that purpose, may examine a witness called by a party.</text> </paragraph> <paragraph num="(5)"> <text>The presiding officer may call as a witness a person necessary to ensure a full and complete record.</text> </paragraph> <paragraph num="(6)"> <text>Any Board member may examine any witness.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Briefs.</text> <paragraph num="(1)"> <text>A party may submit a brief on the issues of fact and law involved in the hearing.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer may designate:</text> <paragraph num="(a)"> <text>The form of the brief;</text> </paragraph> <paragraph num="(b)"> <text>The number of copies to be submitted; and</text> </paragraph> <paragraph num="(c)"> <text>The date and time of submission.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may refuse to consider a brief that is not timely filed or fails to conform to requirements imposed by the presiding officer.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If a party who is the respondent in the proceedings fails to appear at a hearing after due notice, the Board may:</text> <paragraph num="(1)"> <text>Reschedule the hearing; or</text> </paragraph> <paragraph num="(2)"> <text>In the Board's discretion, proceed upon the investigation, report, documents, witnesses, and records before it.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Board shall take testimony under oath.</text> </paragraph> <paragraph num="L."> <text>Decision and Order.</text> <paragraph num="(1)"> <text>A decision and order rendered by the Board shall:</text> <paragraph num="(a)"> <text>Be in writing; and</text> </paragraph> <paragraph num="(b)"> <text>Include the findings of fact and conclusions of law.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party's attorney of record.</text> </paragraph> <paragraph num="(3)"> <text>The findings of fact, conclusions of law, and order referred to in §L of this regulation shall be retained as a permanent record by the Board.</text> </paragraph> </paragraph> <paragraph num="M."> <text>A party aggrieved by a final decision of the Board under Health Occupations Article, §12-313, Annotated Code of Maryland, may seek judicial review of the Board's decision.</text> </paragraph> <paragraph num="N."> <text>The review referenced in §M shall be in accordance with State Government Article, §§10-222 — 10-223, Annotated Code of Maryland.</text> </paragraph> <paragraph num="O."> <text>Rehearings.</text> <paragraph num="(1)"> <text>Within 10 days after service on a party of the decision of the Board, the party may apply to the Board for rehearing.</text> </paragraph> <paragraph num="(2)"> <text>The application shall state the grounds for rehearing.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall grant or deny the application within 20 days of submission to the Board.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise ordered, neither the rehearing nor the application for rehearing shall:</text> <paragraph num="(a)"> <text>Stay the enforcement of the order; or</text> </paragraph> <paragraph num="(b)"> <text>Excuse the persons affected by the order for failure to comply with the terms of the order.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>At a rehearing, the Board shall only consider facts not presented in the original proceeding, including facts arising after the date of the original proceeding.</text> </paragraph> <paragraph num="(6)"> <text>By new order, the Board may abrogate, change, or modify its original order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Exceptions Hearings."> <paragraph num="A."> <text>If a case has been delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland, for proposed findings of fact, conclusions of law, and disposition, a party may file exceptions with the Board within 30 days of receipt of the recommended decision.</text> </paragraph> <paragraph num="B."> <text>The opposing party to the exceptions shall respond within 15 days of receipt of the exceptions.</text> </paragraph> <paragraph num="C."> <text>If a party files exceptions, the Board shall schedule a hearing to be held before a quorum of the Board.</text> </paragraph> <paragraph num="D."> <text>The exceptions hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions to the recommended decision.</text> </paragraph> <paragraph num="E."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Consider:</text> <paragraph num="(a)"> <text>The exceptions;</text> </paragraph> <paragraph num="(b)"> <text>Responses to exceptions; and</text> </paragraph> <paragraph num="(c)"> <text>The record in the case; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Issue an order containing accepted findings of fact, conclusions of law, and disposition.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The presiding officer:</text> <paragraph num="(1)"> <text>Shall determine procedural issues governed by this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>May:</text> <paragraph num="(a)"> <text>Impose reasonable time limitations; and</text> </paragraph> <paragraph num="(b)"> <text>Make rulings reasonably necessary to facilitate the effective and efficient operation of the exceptions hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If the parties do not file timely exceptions, a quorum of the Board shall:</text> <paragraph num="(1)"> <text>Consider the recommended decision from the Office of Administrative Hearings; and</text> </paragraph> <paragraph num="(2)"> <text>Issue an order based on the:</text> <paragraph num="(a)"> <text>Board's accepted findings of fact and conclusions of law; and</text> </paragraph> <paragraph num="(b)"> <text>The record of the case.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Summary Suspensions."> <paragraph num="A."> <text>The Board shall order the summary suspension of a registration, license, or permit if the Board determines that there is a substantial likelihood that a registrant or licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(1)"> <text>A notice of an intent to summarily suspend a registration, license, or permit; or</text> </paragraph> <paragraph num="(2)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board votes to issue a notice of intent to summarily suspend a registration, license, or permit or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="D."> <text>Service of the notice of intent to summarily suspend a registration, license, or permit shall be made by:</text> <paragraph num="(1)"> <text>Hand delivery in person;</text> </paragraph> <paragraph num="(2)"> <text>Certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(3)"> <text>Other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>A notice of intent to summarily suspend a registration, license, or permit shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and which includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the registrant or licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request an evidentiary hearing of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board:</text> <paragraph num="(i)"> <text>To show cause why the Board should not execute the order of summary suspension; and</text> </paragraph> <paragraph num="(ii)"> <text>Which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Predeprivation Hearing.</text> <paragraph num="(a)"> <text>If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's registration, license, or permit should not be summarily suspended.</text> </paragraph> <paragraph num="(b)"> <text>The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(c)"> <text>The presiding officer:</text> <paragraph num="(i)"> <text>Shall determine procedural issues;</text> </paragraph> <paragraph num="(ii)"> <text>May impose reasonable time limits on each party's oral argument; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Order of Summary Suspension.</text> <paragraph num="(1)"> <text>The Board may order the summary suspension of a registration, license, or permit without first issuing a notice of intent to summarily suspend or providing a respondent with a predeprivation hearing if the Board determines that the threat to public health, safety, and welfare requires the immediate suspension of the registration, license, or permit.</text> </paragraph> <paragraph num="(2)"> <text>Postdeprivation Hearing.</text> <paragraph num="(a)"> <text>The respondent shall be provided with a show cause hearing within a reasonable time after the effective date of the order of summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The show cause hearing under §F(2)(a) of this regulation shall:</text> <paragraph num="(i)"> <text>Be conducted before the Board as provided in §E(2) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>After the show cause hearing, if the Board votes to continue the summary suspension, the respondent may request an evidentiary hearing before the Board.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing:</text> <paragraph num="(a)"> <text>May be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be conducted under the Administrative Procedure Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for the stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm the order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings is a:</text> <paragraph num="(a)"> <text>Final order of the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Public record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Surrender of a Registration, License, or Permit."> <paragraph num="A."> <text>The Board may:</text> <paragraph num="(1)"> <text>Accept the surrender of a registration, license, or permit;</text> </paragraph> <paragraph num="(2)"> <text>Require conditions for surrender of a registration, license, or permit, including:</text> <paragraph num="(a)"> <text>The admission of a violation of the Maryland Pharmacy Act;</text> </paragraph> <paragraph num="(b)"> <text>The admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future registration, licensing, or permit;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the registration, license, or permit; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not again apply for a registration, license, or permit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A letter of surrender is a final order of the Board and is a public record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Probation and Violation of Probation."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation that the Board considers appropriate, including:</text> <paragraph num="(1)"> <text>Re-education or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Practicing pharmacy or operating a pharmacy under supervision;</text> </paragraph> <paragraph num="(4)"> <text>Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board;</text> </paragraph> <paragraph num="(5)"> <text>Periodic review of a licensee's practice or operations;</text> </paragraph> <paragraph num="(6)"> <text>Periodic audits of a licensee's billing practice;</text> </paragraph> <paragraph num="(7)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(8)"> <text>Limitation of the licensee's practice or operations;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the pharmacy technician's scope of duties;</text> </paragraph> <paragraph num="(10)"> <text>Drug screenings;</text> </paragraph> <paragraph num="(11)"> <text>Individual or group counseling or therapy;</text> </paragraph> <paragraph num="(12)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(13)"> <text>Any other condition the Board considers appropriate for the rehabilitation or retraining of a registrant or a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the registrant or licensee.</text> </paragraph> <paragraph num="C."> <text>A registrant or licensee seeking release from probation shall do so by petitioning the Board to terminate the probation when the:</text> <paragraph num="(1)"> <text>Specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>Registrant or licensee has successfully completed the conditions or acts required for release.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If, at any time, the Board has reason to believe that the registrant or licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the registrant or licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take an action provided for in the final order in the event of a violation of probation, including suspension of the registration, license, or permit;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the registration, license, or permit; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and which the Board may take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Board determines that the respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take an action provided for in the final order in the event of a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions or probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a sanction or take any other action that the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Reinstatement."> <paragraph num="A."> <text>A registrant or licensee shall petition the Board for a lifting of the suspension of a registration, license, or permit or a reinstatement following revocation or surrender of a registration, license, or permit.</text> </paragraph> <paragraph num="B."> <text>The Board may reinstate a registration, license, or permit in accordance with:</text> <paragraph num="(1)"> <text>The terms and conditions of the order of revocation or suspension;</text> </paragraph> <paragraph num="(2)"> <text>A letter of surrender;</text> </paragraph> <paragraph num="(3)"> <text>An order of reinstatement issued by the Board; or</text> </paragraph> <paragraph num="(4)"> <text>A final judgment in any proceeding for judicial review.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If not otherwise specified in a document under §B of this regulation, the licensee shall meet the requirements of COMAR 10.34.13 to reinstate a license or permit.</text> </paragraph> <paragraph num="C-1."> <text>If not otherwise specified in a document under §B of this regulation, the registrant shall meet the requirements of COMAR 10.34.34 to reinstate a registration.</text> </paragraph> <paragraph num="D."> <text>If a time period is not specified in the Board's final order, a petition for reinstatement may not be considered by the Board before the expiration of 1 year after the date of the order.</text> </paragraph> <paragraph num="E."> <text>The form of a reinstated registration, license, or permit shall:</text> <paragraph num="(1)"> <text>Be similar in every respect to an original registration, license, or permit; and</text> </paragraph> <paragraph num="(2)"> <text>Bear the new date of issue.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the Board grants reinstatement of a registration, license, or permit, it may impose any restrictions or conditions on the registration, license, or the licensee's practice that it considers appropriate.</text> </paragraph> <paragraph num="G."> <text>The Board may reinstate the license of an individual whose license has been revoked under Criminal Law Article, §5-702, Annotated Code of Maryland, if:</text> <paragraph num="(1)"> <text>The individual has petitioned the Board for reinstatement;</text> </paragraph> <paragraph num="(2)"> <text>The petition for reinstatement is made to the Board after the expiration of 5 years after the revocation;</text> </paragraph> <paragraph num="(3)"> <text>The individual has met the requirements of COMAR 10.34.13 to reinstate a license; and</text> </paragraph> <paragraph num="(4)"> <text>The individual has made restitution to aggrieved persons that may have resulted from a violation and conviction of Criminal Law Article, §5-702, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-313, 12-315, 12-6B-09 and 12-6D-11; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 1, 1971</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, E, G amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective February 13, 1984 (11:3 Md. R. 202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, G amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, G amended effective October 3, 1980 (7:20 Md. R. 1879)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 24, 2000 (27:1 Md. R. 77)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07 repealed and new Regulations .01 — .15 adopted effective September 1, 2003 (30:17 Md. R. 1203)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Annotation: COMAR 10.34.01.03G(1) cited in Eichberg v. Board of Pharmacy, 50 Md. App. 189 (1981)</annotation> </annotations> </chapter> <chapter num="02" heading="Examination for Licensure and Professional Experience Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>Applicants for licensure as a pharmacist; and</text> </paragraph> <paragraph num="B."> <text>Internship programs for student pharmacists for which credit may be allowed toward licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Foreign school or college of pharmacy” means a school or college of pharmacy that is not located in any state of the United States.</text> </paragraph> <paragraph num="(3)"> <text>“Licensure examinations” means the Board-administered or Board-approved examinations required of applicants for licensure which include the following:</text> <paragraph num="(a)"> <text>Exam I: North American Pharmacist Licensure Examination (NAPLEX);</text> <paragraph num="(i)"> <text>Part I: NAPLEX, and</text> </paragraph> <paragraph num="(ii)"> <text>Part II: Pharmacy Law Test;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Exam II: Pharmacy Law Test through either:</text> <paragraph num="(i)"> <text>The Uniform Multistate Pharmacy Jurisprudence Examination (UMPJE) and the Maryland Pharmacy Law webinar and post-webinar test; or</text> </paragraph> <paragraph num="(ii)"> <text>The Maryland Multistate Pharmacy Jurisprudence Examination (MPJE); and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Exam III:</text> <paragraph num="(i)"> <text>Prescreening Test of Oral English Competency; or</text> </paragraph> <paragraph num="(ii)"> <text>Test of Oral English Competency.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Examinations."> <paragraph num="A."> <text>Examination Eligibility.</text> <paragraph num="(1)"> <text>An applicant may be approved by the Board to take Exam I upon satisfactory proof that the applicant has graduated, or is expected to graduate at the completion of the immediate semester, from a school or college of pharmacy that has been:</text> <paragraph num="(a)"> <text>Approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Accredited by the American Council on Pharmaceutical Education (ACPE).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Beginning May 1, 2027, an applicant may be approved by the Board to take Exam II upon satisfactory proof that the applicant has graduated from, or has successfully completed the didactic portion of the core curriculum of a school or college of pharmacy that has been:</text> <paragraph num="(a)"> <text>Approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Accredited by the American Council on Pharmaceutical Education (ACPE).</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant may not receive a license until the applicant has:</text> <paragraph num="(1)"> <text>Obtained passing scores on Exam I, Exam II, and Exam III, as applicable; and</text> </paragraph> <paragraph num="(2)"> <text>Provided satisfactory proof to the Board of the applicant’s graduation from a college or school of pharmacy approved by the Board or accredited by the American Council on Pharmaceutical Education (ACPE).</text> </paragraph> </paragraph> <paragraph num="C."> <text>Passing Scores—Exam I and Exam II.</text> <paragraph num="(1)"> <text>The passing score for Exam I is 75.</text> </paragraph> <paragraph num="(2)"> <text>II Passing Scores.</text> <paragraph num="(a)"> <text>For the Maryland Multistate Pharmacy Jurisprudence Examination (MPJE) the passing score is 75.</text> </paragraph> <paragraph num="(b)"> <text>For the Uniform Multistate Pharmacy Jurisprudence Examination (UMPJE) the passing score is 75.</text> </paragraph> <paragraph num="(c)"> <text>Maryland Pharmacy Law Webinar and Post-Webinar Exam.</text> <paragraph num="(i)"> <text>The passing score is 85.</text> </paragraph> <paragraph num="(ii)"> <text>The Maryland Pharmacy Law webinar and post-webinar exam shall provide unlimited attempts to pass the exam in one sitting provided that the applicant reviews the webinar after each failed attempt at the exam.</text> </paragraph> <paragraph num="(iii)"> <text>There may not be a fee associated with the Maryland Pharmacy Law webinar and post-webinar exam.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a candidate receives a passing score on Exam I or Exam II, the candidate is not required to retake that exam unless the passing score was received more than 2 years before the date the candidate successfully completed all of the other examination requirements set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Passing Score—Exam III.</text> <paragraph num="(1)"> <text>Prescreening Test of Oral English Competency.</text> <paragraph num="(a)"> <text>On completion of a prescreening test application form provided by the Board, an applicant may elect to take a standardized prescreening test of oral English competency given by the Board's agents at times to be determined by the Board.</text> </paragraph> <paragraph num="(b)"> <text>An agent of the Board possessing post-secondary credentials in an academic discipline acceptable to the Board shall score the prescreening test of oral English competency through the use of a standardized rating system.</text> </paragraph> <paragraph num="(c)"> <text>An agent of the Board shall design the rating system of the prescreening test so that a passing score demonstrates that an applicant speaks fluent English as proficiently as typical United States native speakers whose English is easily understood by the average pharmacy patient or customer.</text> </paragraph> <paragraph num="(d)"> <text>By choosing to take the prescreening test of oral English competency, an applicant is certifying to the Board that the applicant speaks English as proficiently as typical United States native speakers whose English is easily understood by the average pharmacy patient or customer.</text> </paragraph> <paragraph num="(e)"> <text>By choosing to take the prescreening test to verify this certification, the applicant consents to pay the costs of test administration and shall pay the fee indicated on the Board's prescreening application form directly to the Board's agent.</text> </paragraph> <paragraph num="(f)"> <text>An applicant who passes the prescreening test passes Exam II, the Test of Oral English Competency required under Regulation .02B(2)(b) of this chapter.</text> </paragraph> <paragraph num="(g)"> <text>An applicant who fails the prescreening test for oral English competency may take the Test of Oral English Competency required under Regulation .02B(2)(b) of this chapter without prejudice to the applicant's licensure application if the applicant pays all related fees.</text> </paragraph> <paragraph num="(h)"> <text>An applicant who has graduated from a recognized English-speaking professional school accredited by the Accreditation Council for Pharmacy Education is deemed to be proficient in the oral communication of the English language in satisfaction of requirements of the prescreening test.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Test of Oral English Competency.</text> <paragraph num="(a)"> <text>In order to obtain a license to practice pharmacy, an applicant shall pass a standardized test of oral English competency approved by the Board or the board of pharmacy of another state with a score acceptable to the Board, based upon the Board's standards and the examination taken.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall provide the applicant with a list of Board-approved testing services and the passing score for each approved test of oral English competency.</text> </paragraph> <paragraph num="(c)"> <text>Waiver. The Board shall waive the requirement as set forth under §D(2)(a) of this regulation if the applicant graduated from a recognized English-speaking professional school accredited by the Accreditation Council for Pharmacy Education.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Claims of Speech Impairment.</text> <paragraph num="(a)"> <text>An applicant who claims to have a speech impairment shall submit documentation of the impairment on forms supplied by the Board and completed by a Board-approved:</text> <paragraph num="(i)"> <text>Licensed physician; and</text> </paragraph> <paragraph num="(ii)"> <text>Speech-language pathologist licensed to practice speech pathology in the United States.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The applicant shall submit the documentation with:</text> <paragraph num="(i)"> <text>The applicant's initial application; or</text> </paragraph> <paragraph num="(ii)"> <text>Before the applicant's second attempt at passing the test of oral English competency.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>After the second examination, the applicant may not submit documentation of impairment unless:</text> <paragraph num="(i)"> <text>An intervening medical or surgical event caused the impairment;</text> </paragraph> <paragraph num="(ii)"> <text>The applicant claims the impairment before a third examination; and</text> </paragraph> <paragraph num="(iii)"> <text>The applicant provides documentation that is approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The Board may accept documentation of a speech impairment as a passing score on Exam II if the applicant also:</text> <paragraph num="(i)"> <text>Provides documentation from a Board-approved licensed pharmacist or a Board-approved instructor in a school of pharmacy that the applicant can communicate in a professionally competent manner with patients and health care providers; and</text> </paragraph> <paragraph num="(ii)"> <text>Describes, in a hearing before the Board, the manner in which the applicant would communicate with a licensed prescriber regarding a prescription and would counsel a typical patient on proper drug usage.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The certifying or verifying authority shall send all certificates and verifications directly to the Board for the applicants.</text> </paragraph> <paragraph num="(5)"> <text>The Board-approved testing services may not accept certificates and verifications sent to or by the applicant.</text> </paragraph> <paragraph num="(6)"> <text>If any of the documents required under this regulation are in a language other than English, the certifying or verifying authority shall submit a certified translation.</text> </paragraph> <paragraph num="(7)"> <text>The applicant shall bear the costs of:</text> <paragraph num="(a)"> <text>Translation by a certified translator;</text> </paragraph> <paragraph num="(b)"> <text>Taking the test of oral English competency; and</text> </paragraph> <paragraph num="(c)"> <text>Obtaining documents required under this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Graduates of a Foreign School or College of Pharmacy.</text> <paragraph num="(1)"> <text>In addition to the other examination requirements set forth in this regulation, an applicant who has graduated from a foreign school or college of pharmacy shall:</text> <paragraph num="(a)"> <text>Be approved to take the Foreign Pharmacy Graduate Equivalency Examination (FPGEE); and</text> </paragraph> <paragraph num="(b)"> <text>Obtain the Foreign Pharmacy Graduate Education Committee (FPGEC) Certificate.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The passing score for the FPGEE is 75.</text> </paragraph> <paragraph num="(3)"> <text>Upon successful completion of the FPGEE and submission of the FPGE Certificate, an applicant may be approved by the Board to take Exam I and Exam II.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Internship Program or Training Required."> <text>An applicant shall complete one of the following as a prerequisite to Board licensure:</text> <paragraph num="A."> <text>1,000 hours of a school-supervised professional experience program conducted by a school of pharmacy accredited by the American Council of Pharmaceutical Education; or</text> </paragraph> <paragraph num="B."> <text>1,560 hours of full-time training, as a registered pharmacy intern under the direct supervision of licensed pharmacists pursuant to Regulation .05 of this chapter as an applicant who:</text> <paragraph num="(1)"> <text>Has graduated from a foreign school of pharmacy; or</text> </paragraph> <paragraph num="(2)"> <text>Does not meet the requirements of §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant may receive credit for any of the 1,560 hours earned up to 10 months before the effective date of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Partial or Non-Pharmacy-School-Supervised Program of Internship."> <paragraph num="A."> <text>Applicants may complete the requirement for internship training by having at least 1,560 hours of full-time training as a registered pharmacy intern, under the direct supervision of licensed pharmacists.</text> </paragraph> <paragraph num="B."> <text>The licensed pharmacists providing direct supervision shall be approved by the Board.</text> </paragraph> <paragraph num="C."> <text>The applicant shall present evidence satisfactory to the Board that the applicant has completed the training under this regulation, validated by the supervising pharmacist or pharmacists.</text> </paragraph> <paragraph num="D."> <text>If an approved school or college of pharmacy offers a partial fulfillment of internship requirements as a part of its curriculum, time spent in a program by an applicant may be accepted by the Board on an equivalent basis to replace a portion of the required 1,560-hour internship pharmacy internship training under this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-302, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 6, 1975 (2:17 Md. R. 1188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 1, 1994 (21:14 Md. R. 1229); November 3, 1997 (24:22 Md. R. 1551)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.05 recodified as Regulations .03—.06 effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 9, 1984 (11:7 Md. R. 625); February 19, 1990 (17:3 Md. R. 298); November 1, 1994 (21:14 Md. R. 1229); November 3, 1997 (24:22 Md. R. 1551)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 17, 2003 (30:3 Md. R. 180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 2, 2026 (53:4 Md. R. 185)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 20, 2005 (32:12 Md. R. 1047; March 2, 2026 (53:4 Md. R. 185)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective July 3, 2017 (44:13 Md. R. 621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, D amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> </annotations> </chapter> <chapter num="03" heading="Institutional Pharmacy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>A permit holder that operates a pharmacy that services an inpatient setting; and</text> </paragraph> <paragraph num="B."> <text>A person or entity that holds a pharmacy permit and operates a pharmacy in or for an institutional facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is:</text> <paragraph num="(a)"> <text>Dependent on another institutional pharmacy for:</text> <paragraph num="(i)"> <text>Administrative control;</text> </paragraph> <paragraph num="(ii)"> <text>Staffing with a licensed pharmacist physically available on site in the decentralized pharmacy to supervise the performance of delegated pharmacy acts; and</text> </paragraph> <paragraph num="(iii)"> <text>Drug procurement; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Located in the same building or pavilion as the other institutional pharmacy.</text> </paragraph> </paragraph> <paragraph num="(1-1)"> <text>“Direct supervision” means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts.</text> </paragraph> <paragraph num="(1-2)"> <text>“Director of pharmacy” means a pharmacist who is responsible for the pharmacy services provided by an institutional pharmacy in compliance with appropriate State and federal laws and regulations.</text> </paragraph> <paragraph num="(2)"> <text>“Dispense” or “dispensing” means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agent and which entails the:</text> <paragraph num="(a)"> <text>Interpretation of an authorized prescriber’s prescription for a drug or device;</text> </paragraph> <paragraph num="(b)"> <text>Selection and labeling of the drug or device prescribed pursuant to that prescription; and</text> </paragraph> <paragraph num="(c)"> <text>Measuring and packaging of the prescribed drug or device in accordance with State and federal laws.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Distribute.</text> <paragraph num="(a)"> <text>“Distribute” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Title 12, Annotated Code of Maryland, prior to administration of the provided drug or device to the patient pursuant to a prescription issued by an authorized prescriber.</text> </paragraph> <paragraph num="(b)"> <text>“Distribute” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12–6C–03, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Drug” means a prescription or non-prescription medication or other material used in the diagnosis or treatment of injury, illness, or disease.</text> </paragraph> <paragraph num="(5)"> <text>“Drug recall” means the recall of a drug by a manufacturer or the U.S. Food and Drug Administration (FDA) in the event that there is a reasonable possibility that the use of or exposure to an affected product may cause either:</text> <paragraph num="(a)"> <text>Adverse effects on health; or</text> </paragraph> <paragraph num="(b)"> <text>Death.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Emergency drug supply” means a process for supplying drugs which:</text> <paragraph num="(a)"> <text>May be required for the emergency need of a patient; and</text> </paragraph> <paragraph num="(b)"> <text>Is not available from an authorized source in a timely manner.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Institutional facility” or “institution” means an entity other than a comprehensive care facility, assisted living facility, developmental disabilities facility, or correctional facility whose primary purpose is to provide a physical environment for patients to obtain inpatient, outpatient, or emergency care, except for urgent care facilities that are not part of an institution.</text> </paragraph> <paragraph num="(8)"> <text>“Institutional medication protocol” means a course of therapy including drug treatment predetermined and documented by the institution and the generally accepted medical practice for proper completion of a particular therapeutic or diagnostic intervention ordered by an authorized prescriber and which allows the pharmacist to execute the protocol.</text> </paragraph> <paragraph num="(9)"> <text>“Institutional pharmacy” means a pharmacy which:</text> <paragraph num="(a)"> <text>Provides services to an acute care, rehabilitation, transitional care, chronic care, or mental health hospital;</text> </paragraph> <paragraph num="(b)"> <text>Engages in compounding, distributing, or dispensing of drugs;</text> </paragraph> <paragraph num="(c)"> <text>May provide nondispensing functions as described in Regulation .16 of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Has been issued a pharmacy permit pursuant to Health Occupations Article, §§12-401 and 12-403(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy.</text> </paragraph> <paragraph num="(11)"> <text>“Medication order” means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber’s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the:</text> <paragraph num="(a)"> <text>Date ordered;</text> </paragraph> <paragraph num="(b)"> <text>Drug name;</text> </paragraph> <paragraph num="(c)"> <text>Dosage;</text> </paragraph> <paragraph num="(d)"> <text>Dosage form;</text> </paragraph> <paragraph num="(e)"> <text>Patient name with second identifier such as date of birth or medical record number;</text> </paragraph> <paragraph num="(f)"> <text>Route of administration;</text> </paragraph> <paragraph num="(g)"> <text>Administration instructions, if appropriate; and</text> </paragraph> <paragraph num="(h)"> <text>Signature, if appropriate, of an:</text> <paragraph num="(i)"> <text>Authorized prescriber, as defined in Health Occupations Article, §12-101(b), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Individual permitted to practice medicine without a license as defined in Health Occupations Article, §14-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Order-sets” means predefined orders, including medication orders, that are based on an institutionally approved protocol.</text> </paragraph> <paragraph num="(12-1)"> <text>“Pavilion” means a detached or semidetached part of a hospital devoted to a special use.</text> </paragraph> <paragraph num="(13)"> <text>Pharmaceutical care.</text> <paragraph num="(a)"> <text>“Pharmaceutical care” means the provision of a patient’s drug regimen for the purpose of:</text> <paragraph num="(i)"> <text>Achieving definite outcomes related to the cure or prevention of a disease;</text> </paragraph> <paragraph num="(ii)"> <text>Elimination or reduction of a patient’s symptoms; or</text> </paragraph> <paragraph num="(iii)"> <text>Arresting or slowing of a disease process by identifying, resolving, or preventing actual or potential drug therapy problems.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Pharmaceutical care” may include patient counseling and providing information to licensed and certified health care providers.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Prescription Drug.</text> <paragraph num="(a)"> <text>“Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription.</text> </paragraph> <paragraph num="(b)"> <text>“Prescription drug” includes:</text> <paragraph num="(i)"> <text>A biological product; and</text> </paragraph> <paragraph num="(ii)"> <text>Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug and Cosmetic Act.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Second identifier” means a reliable method to:</text> <paragraph num="(a)"> <text>Identify a patient for whom service or treatment is intended; and</text> </paragraph> <paragraph num="(b)"> <text>Match the service or treatment intended to the patient.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Verbal order” means a medication order from an authorized prescriber which is received by an authorized licensed practitioner using appropriate read back procedures that is subsequently recorded in the patient’s chart and countersigned by the prescriber within a time period required by the institution.</text> </paragraph> <paragraph num="(17)"> <text>“Written order” means a medication order that is recorded as a written document by an authorized prescriber.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Issuance of Permits."> <paragraph num="A."> <text>An institutional pharmacy shall obtain required permits in compliance with State and federal laws and regulations.</text> </paragraph> <paragraph num="B."> <text>An institutional pharmacy shall:</text> <paragraph num="(1)"> <text>Staff a pharmacist at each decentralized pharmacy site within the building or pavilion in which it is located; and</text> </paragraph> <paragraph num="(2)"> <text>List decentralized pharmacy sites within the building in which it is located, on the initial application, or on the renewal application;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A decentralized pharmacy that meets the definition as set forth in this chapter may operate under the same permit as the institutional pharmacy located in the same building or pavilion.</text> </paragraph> <paragraph num="D."> <text>If full service pharmacy services are provided to discharge patients, employees, clinic patients, or others, an institutional pharmacy shall obtain a full service pharmacy permit.</text> </paragraph> <paragraph num="E."> <text>Any other pharmacy that does not meet the requirements of a decentralized pharmacy and is located on the campus or affiliated with an institutional pharmacy shall be separately licensed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Policies and Procedures."> <paragraph num="A."> <text>The director of pharmacy shall establish and operate under a policies and procedures manual which:</text> <paragraph num="(1)"> <text>Complies with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Defines the scope and method of pharmacy services provided to the patients of the institutional facility;</text> </paragraph> <paragraph num="(3)"> <text>Determines when personnel may have access to the pharmacy area;</text> </paragraph> <paragraph num="(4)"> <text>Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;</text> </paragraph> <paragraph num="(5)"> <text>Includes:</text> <paragraph num="(a)"> <text>Labeling requirements that meet the requirements of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Distribution methods for medication that assures that a patient receives the correct dose ordered by the prescriber;</text> </paragraph> <paragraph num="(c)"> <text>Packaging methods that assure the medication is appropriately identified, designed to maintain stability until expiration and traceable throughout the distribution chain to facilitate recall;</text> </paragraph> <paragraph num="(d)"> <text>Distribution methods that provide for safe handling of medications that may be manual or computerized employing centralized, decentralized, or remote devices that meet the requirements of COMAR 10.34.28.</text> </paragraph> <paragraph num="(e)"> <text>Pharmacy security methods that comply with this chapter;</text> </paragraph> <paragraph num="(f)"> <text>Conditions in which an emergency drug supply may be replenished or prepared, delivered, and stored by the institutional facility;</text> </paragraph> <paragraph num="(g)"> <text>Duties that may be performed by a licensed pharmacist, registered pharmacy technician and unlicensed personnel; and</text> </paragraph> <paragraph num="(h)"> <text>Methods for proper disposal of pharmaceuticals as required by State and federal law;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is provided to:</text> <paragraph num="(a)"> <text>The personnel of the pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>The institutional facility; and</text> </paragraph> <paragraph num="(c)"> <text>Upon request, an agent of the Board; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Is in a form that is:</text> <paragraph num="(a)"> <text>Written or electronic; and</text> </paragraph> <paragraph num="(b)"> <text>Readily retrievable;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The director of pharmacy shall provide annual training on the policies and procedures manual to the personnel of the pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Personnel."> <paragraph num="A."> <text>The permit holder shall appoint a licensed pharmacist as director of pharmacy who shall:</text> <paragraph num="(1)"> <text>Be in full and actual charge of the pharmacy and its personnel;</text> </paragraph> <paragraph num="(2)"> <text>Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title; and</text> </paragraph> <paragraph num="(3)"> <text>Review the policies and procedures of the pharmacy annually and revise them as necessary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff.</text> <paragraph num="(1)"> <text>The pharmacy permit holder shall employ licensed pharmacists, registered pharmacy technicians, and unlicensed personnel as required to competently and safely provide pharmacy services.</text> </paragraph> <paragraph num="(2)"> <text>The director of pharmacy shall delegate responsibility for the operations of the pharmacy to a designated pharmacist when the director of pharmacy is not available.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Security."> <paragraph num="A."> <text>If a pharmacist is not present within the pharmacy, the pharmacist shall lock and secure the pharmacy and any of its decentralized areas that contain pharmaceuticals before leaving the pharmacy or the decentralized area.</text> </paragraph> <paragraph num="B."> <text>The director of pharmacy shall establish policies and procedures for emergency access to the pharmacy or any of its decentralized areas.</text> </paragraph> <paragraph num="C."> <text>Security Requirements. Entry into an institutional pharmacy area where prescription drugs or devices are held shall be limited to authorized personnel under a pharmacist’s direct supervision.</text> </paragraph> <paragraph num="D."> <text>An institutional pharmacy shall be equipped with:</text> <paragraph num="(1)"> <text>A security system to detect entry after hours, if applicable;</text> </paragraph> <paragraph num="(2)"> <text>A security system that provides additional protection against theft and diversion;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;</text> </paragraph> <paragraph num="(4)"> <text>An inventory management and control system designed to protect against, detect, and document instances of theft, diversion, or counterfeiting;</text> </paragraph> <paragraph num="(5)"> <text>A security system designed to protect the integrity and confidentiality of data and documents;</text> </paragraph> <paragraph num="(6)"> <text>Video monitoring of entrances and exits, or alternate acceptable security; and</text> </paragraph> <paragraph num="(7)"> <text>A means to make the data and documentation required under this chapter readily available to:</text> <paragraph num="(a)"> <text>The Board;</text> </paragraph> <paragraph num="(b)"> <text>An agent of the Board; or</text> </paragraph> <paragraph num="(c)"> <text>Federal and State regulatory and law enforcement officials.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Physical Requirements and Equipment."> <paragraph num="A."> <text>The institutional pharmacy shall have floor space, shelving, and equipment to ensure that drugs and supplies within the institutional pharmacy are properly stored and prepared with respect to sanitation, temperature, light, ventilation, moisture control, segregation, and security.</text> </paragraph> <paragraph num="B."> <text>The institutional pharmacy shall have professional and technical equipment, supplies, and adequate physical facilities for proper compounding, dispensing, and storage of drugs.</text> </paragraph> <paragraph num="C."> <text>The institutional pharmacy shall have reference materials as required by COMAR 10.34.07.03 to enable personnel to prepare and dispense drugs properly and perform pharmaceutical care functions.</text> </paragraph> <paragraph num="D."> <text>The institutional pharmacy shall store alcohol and flammables in areas that meet basic local building code requirements for the storage of volatiles and such other laws, ordinances, or regulations as may apply.</text> </paragraph> <paragraph num="E."> <text>An institutional pharmacy that provides parenteral preparations shall comply with COMAR 10.34.19.</text> </paragraph> <paragraph num="F."> <text>The institutional pharmacy shall dispose of hazardous materials consistent with State and federal laws and regulations;</text> </paragraph> <paragraph num="G."> <text>The institutional pharmacy is responsible for the maintenance of the institution’s automated medication systems in compliance with COMAR 10.34.28</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsibilities of Director of Pharmacy."> <text>The director of pharmacy or designee shall:</text> <paragraph num="A."> <text>Be responsible for the safe and efficient dispensing, control, security, and accountability of drugs;</text> </paragraph> <paragraph num="B."> <text>Work in cooperation with the other professional staff of the institutional facility with respect to the duties listed in this regulation and in ordering, administering, and controlling drug products and materials, including prescription blanks;</text> </paragraph> <paragraph num="C."> <text>Supervise the preparation of parenteral and other medications compounded within the institutional facility;</text> </paragraph> <paragraph num="D."> <text>Provide written policies and procedures to hospital professional and technical staff with regard to admixtures prepared within the institution outside of the institutional pharmacy including, but not limited to:</text> <paragraph num="(1)"> <text>Establishing policies and procedures for preparation and handling of the admixtures; and</text> </paragraph> <paragraph num="(2)"> <text>Providing incompatibility information with respect to the admixtures;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Recommend specifications for procurement, storage and disposal of drugs, chemicals, and biologicals administered to patients to the appropriate committee of the institutional facility as determined by the governing body;</text> </paragraph> <paragraph num="F."> <text>Participate in the development of a formulary for the facility;</text> </paragraph> <paragraph num="G."> <text>Establish procedures for the development of a standard format and ongoing procedures for checking the accuracy and placement of labels on medications throughout the institution;</text> </paragraph> <paragraph num="H."> <text>Maintain and make available an inventory of antidotes and other emergency drugs, both in the pharmacy and in patient care areas, as well as:</text> <paragraph num="(1)"> <text>Current antidote information;</text> </paragraph> <paragraph num="(2)"> <text>Telephone numbers of a regional poison information center;</text> </paragraph> <paragraph num="(3)"> <text>Other emergency assistance organizations; and</text> </paragraph> <paragraph num="(4)"> <text>Such other materials and information as may be considered necessary by the governing body of the institutional facility;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Maintain records of transactions of the institutional pharmacy as may be required by applicable law and as may be necessary to maintain accurate control and accountability for pharmaceuticals;</text> </paragraph> <paragraph num="J."> <text>Participate in those aspects of the institutional facility's quality assurance and improvement program which relate to medication safety and pharmaceutical utilization and effectiveness;</text> </paragraph> <paragraph num="K."> <text>Participate in teaching or research programs, or both, in the institutional facility as required;</text> </paragraph> <paragraph num="L."> <text>Implement the policies, procedures, and decisions of the governing body of the institutional facility;</text> </paragraph> <paragraph num="M."> <text>Ensure that a system is in place that provides a safe, secure, and efficient distribution system for pharmaceutical products within the facility;</text> </paragraph> <paragraph num="N."> <text>Ensure that the institutional pharmacy meets inspection and other requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and these regulations;</text> </paragraph> <paragraph num="O."> <text>Develop and implement policies and procedures to ensure that discontinued and outdated drugs and drug containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition;</text> </paragraph> <paragraph num="P."> <text>Establish policies and procedures for identification, handling, storage, and disposition of medications brought into the institution by the patients;</text> </paragraph> <paragraph num="Q."> <text>Conduct an on-going plan for a quality assurance program that will review and evaluate pharmaceutical services and recommend improvements in these services;</text> </paragraph> <paragraph num="R."> <text>Establish policies and procedures for identification and handling of investigational drugs that include the provision of pharmacologic and toxicologic information to the medical and nursing staff according to institutional policies ;</text> </paragraph> <paragraph num="S."> <text>Arrange for the inspection of drug storage areas throughout the institution on a monthly basis and maintain written records of these reviews; and</text> </paragraph> <paragraph num="T."> <text>Participate in developing and monitoring the policies and procedures pertaining to:</text> <paragraph num="(1)"> <text>Administration of drugs at an institutional facility to ensure that only authorized individuals administer drugs; and</text> </paragraph> <paragraph num="(2)"> <text>Self-administration of drugs not on the hospital formulary by patients to ensure that the:</text> <paragraph num="(a)"> <text>Administration occurs in accordance with procedures established by the appropriate committee of the institution; and</text> </paragraph> <paragraph num="(b)"> <text>That the self-administration is ordered by an authorized prescriber.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Medication Packaging — Record Keeping."> <paragraph num="A."> <text>A licensed pharmacist shall verify the selection of medication to be packaged and verify the completed packaging of medication performed by a registered pharmacy technician for the following:</text> <paragraph num="(1)"> <text>Accuracy;</text> </paragraph> <paragraph num="(2)"> <text>Completeness:</text> </paragraph> <paragraph num="(3)"> <text>Appropriateness; and</text> </paragraph> <paragraph num="(4)"> <text>Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Packaging from the Manufacturer’s Original Container. The pharmacy shall use a master log with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the:</text> <paragraph num="(1)"> <text>Lot number assigned by the distributor or manufacturer;</text> </paragraph> <paragraph num="(2)"> <text>Manufacturer’s expiration date;</text> </paragraph> <paragraph num="(3)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(4)"> <text>Lot number assigned by the pharmacy;</text> </paragraph> <paragraph num="(5)"> <text>Quantity packaged;</text> </paragraph> <paragraph num="(6)"> <text>Expiration date as defined in §C of this regulations;</text> </paragraph> <paragraph num="(7)"> <text>Generic name of the drug;</text> </paragraph> <paragraph num="(8)"> <text>Strength;</text> </paragraph> <paragraph num="(9)"> <text>Date of packaging;</text> </paragraph> <paragraph num="(10)"> <text>Name of person packaging; and</text> </paragraph> <paragraph num="(11)"> <text>Initials of verifying licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:</text> <paragraph num="(1)"> <text>Twelve months from the date of packaging;</text> </paragraph> <paragraph num="(2)"> <text>The manufacturer’s or distributor’s listed expiration date; or</text> </paragraph> <paragraph num="(3)"> <text>The maximum time period allowed for the specific packaging used for the medication.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The licensed pharmacist shall ensure that labeling of the medication container includes the:</text> <paragraph num="(1)"> <text>Generic name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>Brand name of the medication, if appropriate</text> </paragraph> <paragraph num="(3)"> <text>Strength of the medication, if appropriate;</text> </paragraph> <paragraph num="(4)"> <text>Lot number of the distributor or manufacturer;</text> </paragraph> <paragraph num="(5)"> <text>Expiration date of the medication; and</text> </paragraph> <paragraph num="(6)"> <text>Beyond use date of the medication, if appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Labeling for Use Outside the Institutional Facility."> <paragraph num="A."> <text>The director of pharmacy or designee shall ensure that the labels on drugs dispensed for use outside the facility by an institutional pharmacy to clinics, ambulatory patients, or other patients about to be discharged meet the requirements of Health Occupations Article, §12-505, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The director of pharmacy or designee shall ensure that the labels contain other information that may be required by federal or State law or regulations including, but not limited to, cautionary information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Drug Dispensing — Emergency Supplies and Procedures."> <paragraph num="A."> <text>The director of pharmacy shall participate in the development and maintenance of the formulary for emergency drugs and supplies that are maintained throughout the institutional facility.</text> </paragraph> <paragraph num="B."> <text>The director of pharmacy or designee shall, in conjunction with the medical staff of the institutional facility, develop and implement written policies and procedures to ensure compliance with the provisions of this regulation.</text> </paragraph> <paragraph num="C."> <text>The institutional pharmacy shall furnish emergency drugs and supplies only if:</text> <paragraph num="(1)"> <text>The emergency drugs and supplies are stored in an environment which:</text> <paragraph num="(a)"> <text>Maintains the integrity of the drugs; and</text> </paragraph> <paragraph num="(b)"> <text>Provides accessibility only to authorized personnel;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The institution follows a policy that drugs will be dispensed from the emergency drugs and supplies formulary only upon written or verbal order by an authorized prescriber;</text> </paragraph> <paragraph num="(3)"> <text>The emergency drugs and supplies are stocked and maintained in a manner that complies with the standards of applicable State law;</text> </paragraph> <paragraph num="(4)"> <text>The emergency drugs and supplies are:</text> <paragraph num="(a)"> <text>Stored and secured:</text> <paragraph num="(i)"> <text>With a tamper evident seal; or</text> </paragraph> <paragraph num="(ii)"> <text>Via electronic means; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Kept in a secure area;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The emergency drugs and supplies are labeled as follows:</text> <paragraph num="(a)"> <text>Clearly indicating that the emergency drugs and supplies are for use in emergencies only;</text> </paragraph> <paragraph num="(b)"> <text>Listing the expiration dates of the emergency drugs and supplies;</text> </paragraph> <paragraph num="(c)"> <text>Listing the name or initials of the pharmacist who checked the emergency drugs and supplies; and</text> </paragraph> <paragraph num="(d)"> <text>Highlighting the expiration date of the medication with the shortest expiration date;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>When the emergency drugs and supplies are contained within an emergency cart, the pharmacist checking the emergency cart shall ensure that the exterior of the cart is labeled with the:</text> <paragraph num="(a)"> <text>Contents of the emergency cart; and</text> </paragraph> <paragraph num="(b)"> <text>Name or initials of the pharmacist; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The director of pharmacy or designee shall ensure that repackaged drugs contained in emergency drugs and supplies are labeled:</text> <paragraph num="(a)"> <text>In accordance with Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>With other information as may be required by the medical staff.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Upon notification that emergency drugs and supplies have been opened, a pharmacist or registered pharmacy technician shall:</text> <paragraph num="(1)"> <text>Restock the emergency drugs and supplies; or</text> </paragraph> <paragraph num="(2)"> <text>Provide a replacement supply.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The director of pharmacy or designee shall ensure:</text> <paragraph num="(1)"> <text>That the expiration date of emergency drugs and supplies is the earliest date of expiration of any drug supplied; and</text> </paragraph> <paragraph num="(2)"> <text>Before the expiration date, the pharmacist or designee shall replace the expired drug and relabel the emergency drugs and supplies as provided in §C(5) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Drug Dispensing — Prescribers' Orders."> <paragraph num="A."> <text>Drugs may be dispensed from the institutional pharmacy only in response to medication orders issued by prescribers who have been authorized to do so by law and by the governing body of the institution.</text> </paragraph> <paragraph num="B."> <text>Documentation.</text> <paragraph num="(1)"> <text>Institutional Medication Protocols.</text> <paragraph num="(a)"> <text>The pharmacist may dispense, or make available, drugs for an approved institutional medication protocol if conditions designated by the institution are met.</text> </paragraph> <paragraph num="(b)"> <text>The director of pharmacy or designee shall assist in establishing institutional policies and procedures governing the development of order-sets for each individual situation for which institutional medication protocol orders exist.</text> </paragraph> <paragraph num="(c)"> <text>The appropriate committee of the institution shall approve any order-sets before the pharmacist may provide the medications based on the institutional medication protocol.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pharmacist may provide medications based on orders which do not contain unapproved abbreviations as published by the appropriate committee of the institutional facility.</text> </paragraph> <paragraph num="(3)"> <text>The director of pharmacy or designee shall ensure that authorized personnel have access to patient information necessary for drug monitoring including the patient's:</text> <paragraph num="(a)"> <text>Sex;</text> </paragraph> <paragraph num="(b)"> <text>Age;</text> </paragraph> <paragraph num="(c)"> <text>Weight;</text> </paragraph> <paragraph num="(d)"> <text>Height;</text> </paragraph> <paragraph num="(e)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(f)"> <text>Medication and food allergies;</text> </paragraph> <paragraph num="(g)"> <text>Pregnancy and lactation status;</text> </paragraph> <paragraph num="(h)"> <text>Vaccination status; and</text> </paragraph> <paragraph num="(i)"> <text>Name.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Controlled Dangerous Substances."> <paragraph num="A."> <text>Drug Accountability.</text> <paragraph num="(1)"> <text>The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following:</text> <paragraph num="(a)"> <text>Name and strength of the drug;</text> </paragraph> <paragraph num="(b)"> <text>Dose;</text> </paragraph> <paragraph num="(c)"> <text>Dosage form;</text> </paragraph> <paragraph num="(d)"> <text>Prescriber;</text> </paragraph> <paragraph num="(e)"> <text>Patient name with second identifier;</text> </paragraph> <paragraph num="(f)"> <text>Date and time of administration; and</text> </paragraph> <paragraph num="(g)"> <text>Individual administering the drug;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The director of pharmacy shall be responsible for establishing and maintaining adequate procedures for documentation of:</text> <paragraph num="(a)"> <text>Recording of receipt of delivery to the pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Entering into pharmacy inventory;</text> </paragraph> <paragraph num="(c)"> <text>Receiving into Schedule II inventory; and</text> </paragraph> <paragraph num="(d)"> <text>Dispensing of controlled dangerous substances, Schedule II — Schedule V.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The director of pharmacy or designee shall be responsible for establishing and maintaining adequate procedures for documenting partially administered controlled dangerous substances:</text> <paragraph num="(a)"> <text>For disposal by hospital policy; and</text> </paragraph> <paragraph num="(b)"> <text>Return of unused drugs to the pharmacy.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The director of pharmacy or designee shall establish procedures to ensure that controlled dangerous substance records include the handwritten or electronic signature of the individual authorized:</text> <paragraph num="(a)"> <text>By the institution to dispose of drugs or to return them to the pharmacy; and</text> </paragraph> <paragraph num="(b)"> <text>To witness the disposal, as defined by the institution's policies and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Storage and Security in the Institutional pharmacy.</text> <paragraph num="(1)"> <text>On at least a monthly basis, a pharmacist or registered pharmacy technician shall perform a physical count of each Schedule II controlled dangerous substance in the pharmacy and shall then compare that count with the perpetual inventory maintained by the pharmacy with reference to each drug;</text> </paragraph> <paragraph num="(2)"> <text>On at least a monthly basis, the director of pharmacy or designee shall:</text> <paragraph num="(a)"> <text>Investigate discrepancies within the pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Report losses as required by law; and</text> </paragraph> <paragraph num="(c)"> <text>Take appropriate action; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The director of pharmacy or designee shall establish a procedure by which previously dispensed controlled dangerous substances that are no longer necessary for medical reasons are returned to the pharmacy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Storage and Security in the Institution. The director of pharmacy shall develop policies that only permit the dispensing of controlled dangerous substances when the following security precautions exist in the institution and the pharmacy:</text> <paragraph num="(1)"> <text>Access to controlled dangerous substances outside the pharmacy is restricted to authorized personnel approved by institutional policy;</text> </paragraph> <paragraph num="(2)"> <text>Controlled dangerous substances stored outside the pharmacy are accounted for at least at the change of each shift by licensed personnel authorized by the institution, unless a controlled access automated dispensing system provides an on-demand report of a perpetual inventory; and</text> </paragraph> <paragraph num="(3)"> <text>A pharmacist reviews the discrepancies in counts of controlled dangerous substances previously reported by other professional personnel.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Drug Recalls."> <paragraph num="A."> <text>The director of pharmacy or designee shall develop and implement a drug recall procedure that can be readily activated to assure that drugs which have been recalled are returned to the pharmacy for proper disposition.</text> </paragraph> <paragraph num="B."> <text>If a recall has been initiated for a drug that has been purchased by the institution, the director of pharmacy or designee shall issue a notice in a timely manner informing affected departments of the institution that the drug shall be returned to the pharmacy for proper return or disposal.</text> </paragraph> <paragraph num="C."> <text>The institutional pharmacy is responsible for the timely retrieval of affected drugs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Adverse Drug Events."> <paragraph num="A."> <text>The director of pharmacy or designee shall participate in the appropriate committee or committees to establish procedures to report and record adverse drug events including medication errors and adverse drug reactions.</text> </paragraph> <paragraph num="B."> <text>The director of pharmacy or designee shall immediately report adverse drug events to the prescriber, or the prescriber's designee, and make a written or electronic report to the appropriate committee or committees, as determined by the governing body of the institutional facility.</text> </paragraph> <paragraph num="C."> <text>The director of pharmacy shall participate in the deliberations of the institutional committee charged with the development of the programmatic and operational changes that result from the analysis of medication errors or other adverse events.</text> </paragraph> <paragraph num="D."> <text>The director of pharmacy, in collaboration with the medical staff and other appropriate departments and services, shall develop and maintain a process for training staff regarding detecting and reporting medication errors to prevent future occurrences.</text> </paragraph> <paragraph num="E."> <text>The director of pharmacy or designee shall make further reports of adverse reactions as required by federal or State law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Pharmaceutical Care Functions of the Pharmacist."> <text>The pharmacist shall be available as necessary to provide pharmaceutical care to individual patients including, but not limited to:</text> <paragraph num="A."> <text>Participating in decisions about medication use for patients including decisions not to use medication therapy as well as judgments about:</text> <paragraph num="(1)"> <text>Medication selection;</text> </paragraph> <paragraph num="(2)"> <text>Dosages;</text> </paragraph> <paragraph num="(3)"> <text>Routes and methods of administration;</text> </paragraph> <paragraph num="(4)"> <text>Medication therapy monitoring; and</text> </paragraph> <paragraph num="(5)"> <text>The provision of medication-related information and counseling to individual patients;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Cooperating directly with health care professionals and the patient in designing, implementing, and monitoring a therapeutic outcome.</text> </paragraph> <paragraph num="C."> <text>Providing care directly to the patient to improve a patient’s quality of life through achieving definite and predefined, medication-related therapeutic outcomes such as:</text> <paragraph num="(1)"> <text>Curing the disease;</text> </paragraph> <paragraph num="(2)"> <text>Eliminating or reducing a symptomatology;</text> </paragraph> <paragraph num="(3)"> <text>Arresting or slowing a disease process;</text> </paragraph> <paragraph num="(4)"> <text>Preventing a disease or symptomatology; and</text> </paragraph> <paragraph num="(5)"> <text>Improving patient’s quality of life.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Identifying potential and actual medication-related problems, resolving actual medication-related problems, and preventing potential medication-related problems caused by:</text> <paragraph num="(1)"> <text>Untreated indications;</text> </paragraph> <paragraph num="(2)"> <text>Improper drug selection;</text> </paragraph> <paragraph num="(3)"> <text>Sub-therapeutic dosage;</text> </paragraph> <paragraph num="(4)"> <text>Failure to received medication;</text> </paragraph> <paragraph num="(5)"> <text>Over dosage;</text> </paragraph> <paragraph num="(6)"> <text>Adverse drug reactions;</text> </paragraph> <paragraph num="(7)"> <text>Drug interactions, including drug-drug, drug-food, drug-laboratory test interactions; and</text> </paragraph> <paragraph num="(8)"> <text>Medication use without appropriate indication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Requirements for a Decentralized Pharmacy."> <paragraph num="A."> <text>A decentralized pharmacy is subject to:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 12, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(3)"> <text>Other applicable State and federal laws and regulations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A decentralized pharmacy shall ensure that a licensed pharmacist is immediately available on the premises of the decentralized pharmacy to:</text> <paragraph num="(1)"> <text>Supervise pharmacy operations; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the final check for preparing medication orders for administration in the institutional facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notwithstanding §B of this regulation, a pharmacist assigned to a decentralized pharmacy may leave the decentralized pharmacy for a short period of time to perform pharmaceutical care functions in the institutional facility.</text> </paragraph> <paragraph num="D."> <text>A director of pharmacy of the institutional pharmacy shall be responsible for pharmacy operations involving a decentralized pharmacy, including direct supervision of decentralized pharmacy personnel by a pharmacist and compliance with this chapter.</text> </paragraph> <paragraph num="E."> <text>A pharmacy department may store prescription medications and over the counter medications that are approved for use by the institutional pharmacy as required for the treatment of patients in the nursing unit served by the decentralized pharmacy.</text> </paragraph> <paragraph num="F."> <text>An institutional pharmacy and the decentralized pharmacy shall have shared common electronic files or appropriate technology to allow access to sufficient information necessary or required to process functions required for the care of patients within the service area of the decentralized pharmacy.</text> </paragraph> <paragraph num="G."> <text>A decentralized pharmacy shall have a pharmacist physically located at the decentralized pharmacy to directly supervise pharmacy technicians and pharmacy technician trainees during hours of operation.</text> </paragraph> <paragraph num="H."> <text>An institutional pharmacy shall notify the Board in writing within 14 days of a change of location, discontinuance of service, or closure of a decentralized pharmacy.</text> </paragraph> <paragraph num="I."> <text>Security.</text> <paragraph num="(1)"> <text>In addition to the security requirements outlined in COMAR 10.34.05, a decentralized pharmacy shall have adequate security and procedures to:</text> <paragraph num="(a)"> <text>Prohibit unauthorized access;</text> </paragraph> <paragraph num="(b)"> <text>Comply with federal and State regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain patient confidentiality.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Access to the decentralized pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the institutional pharmacy, and other personnel authorized by the director of pharmacy.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 6, 1995 (22:22 Md. R. 1666)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 1, 2011 (38:19 Md. R. 1147)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 31, 2014 (40:19 Md. R. 1547)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 31, 2014 (40:19 Md. R. 1547)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective May 31, 2014 (40:19 Md. R. 1547)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective May 31, 2014 (40:19 Md. R. 1547)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective May 31, 2014 (40:19 Md. R. 1547)</annotation> </annotations> </chapter> <chapter num="04" heading="Transfer and Outsourcing of Prescriptions and Prescription Orders"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the:</text> <paragraph num="A."> <text>Transfer of prescriptions for non-controlled dangerous substances between pharmacies;</text> </paragraph> <paragraph num="B."> <text>Filling of prescriptions at one pharmacy pursuant to the request of staff of a second pharmacy; and</text> </paragraph> <paragraph num="C."> <text>Preparation of medication for stock and investigational use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Outsourcing” means the transmitting of a prescription order from a primary pharmacy to a secondary pharmacy that prepares the prescription.</text> </paragraph> <paragraph num="(2)"> <text>“Patient specific” means a prescription order prepared and labeled for a specific individual.</text> </paragraph> <paragraph num="(3)"> <text>“Preparation” means compounding or packaging of medication.</text> </paragraph> <paragraph num="(4)"> <text>“Primary pharmacy” means the pharmacy that initially receives a prescription order.</text> </paragraph> <paragraph num="(5)"> <text>“Secondary pharmacy” means the pharmacy to which a prescription order is transmitted for subsequent dispensing to a patient.</text> </paragraph> <paragraph num="(6)"> <text>“Stock medication” means medication that is not labeled for, or intended for, use by a specific patient when it leaves the pharmacy, but is intended to be stored and ultimately administered by a licensed health care professional in accordance with applicable laws and regulations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permanent Transfer of a Prescription Between Pharmacies."> <text>A pharmacist from a primary pharmacy may permanently transfer a prescription order to a secondary pharmacy to be dispensed to a specific patient if the pharmacist transferring the prescription from the primary pharmacy indicates on the prescription, within the prescription computer database and within any appropriate other records used for dispensing:</text> <paragraph num="A."> <text>That the prescription has been permanently transferred;</text> </paragraph> <paragraph num="B."> <text>The name of the secondary pharmacy;</text> </paragraph> <paragraph num="C."> <text>The name of the pharmacist who transferred the prescription to the secondary pharmacy;</text> </paragraph> <paragraph num="D."> <text>The name of the pharmacist at the secondary pharmacy to whom the prescription was transferred if the transfer occurred in an oral manner; and</text> </paragraph> <paragraph num="E."> <text>The date on which the prescription was transferred to the secondary pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Refilling of Permanently Transferred Prescriptions."> <paragraph num="A."> <text>A pharmacist at the primary pharmacy may not refill a prescription that has been permanently transferred to a secondary pharmacy.</text> </paragraph> <paragraph num="B."> <text>The use of unified prescription records by more than one pharmacy through a computerized prescription database does not constitute a permanent transfer of a prescription order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer."> <text>The pharmacist at the secondary pharmacy who receives a permanently transferred prescription document is responsible for maintaining documentation in a readily retrievable and identifiable manner which includes:</text> <paragraph num="A."> <text>That the prescription was transferred from another pharmacy;</text> </paragraph> <paragraph num="B."> <text>The name and information identifying the specific location of the primary pharmacy;</text> </paragraph> <paragraph num="C."> <text>The name of the pharmacist who transferred the prescription to the secondary pharmacy;</text> </paragraph> <paragraph num="D."> <text>The name of the pharmacist at the secondary pharmacy who accepted the transferred prescription;</text> </paragraph> <paragraph num="E."> <text>The date of issuance of the original prescription order;</text> </paragraph> <paragraph num="F."> <text>The date on which the prescription order was first filled;</text> </paragraph> <paragraph num="G."> <text>The date of the last refill;</text> </paragraph> <paragraph num="H."> <text>The number of remaining refills;</text> </paragraph> <paragraph num="I."> <text>The original prescription number; and</text> </paragraph> <paragraph num="J."> <text>The date on which the prescription was transferred to the secondary pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Transfers of Prescription for Controlled Dangerous Substances."> <text>A pharmacist may transfer a prescription for a controlled dangerous substance in accordance with federal law.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Outsourcing of a Prescription Order."> <text>A pharmacist from a primary pharmacy may transmit a prescription order to a secondary pharmacy for preparation and final dispensing to a specific patient or for return to the primary pharmacy for final dispensing to a specific patient if:</text> <paragraph num="A."> <text>The label contains the name, address, and phone number of the primary pharmacy;</text> </paragraph> <paragraph num="B."> <text>The patient is informed in writing of the name and address of the secondary pharmacy;</text> </paragraph> <paragraph num="C."> <text>The patient is informed in writing that the prescription order was prepared at a secondary pharmacy;</text> </paragraph> <paragraph num="D."> <text>The original prescription order is filed as a prescription order at the primary pharmacy;</text> </paragraph> <paragraph num="E."> <text>The pharmacist from the primary pharmacy documents in a readily retrievable and identifiable manner:</text> <paragraph num="(1)"> <text>That the prescription order was prepared by a secondary pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>The name of the secondary pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>The name of the pharmacist who transmitted the prescription order to the secondary pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>The name of the pharmacist at the secondary pharmacy to whom the prescription order was transmitted if the transmission occurred in an oral manner;</text> </paragraph> <paragraph num="(5)"> <text>The date on which the prescription was transmitted to the secondary pharmacy; and</text> </paragraph> <paragraph num="(6)"> <text>The date on which the medication was sent to the primary pharmacy;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Both the primary and secondary pharmacies are licensed in this State, or operated by the federal government; and</text> </paragraph> <paragraph num="G."> <text>The primary pharmacy maintains, in a readily retrievable and identifiable manner, a record of preparations received from the secondary pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Documentation by the Secondary Pharmacy when a Prescription Order is Outsourced."> <text>The permit holder at the secondary pharmacy is responsible for maintaining documentation in a readily retrievable and identifiable manner, which includes:</text> <paragraph num="A."> <text>That the prescription order was transmitted from another pharmacy;</text> </paragraph> <paragraph num="B."> <text>The name and information identifying the specific location of the primary pharmacy;</text> </paragraph> <paragraph num="C."> <text>The name of the pharmacist who transmitted the prescription to the secondary pharmacy if the transmission occurred in an oral manner;</text> </paragraph> <paragraph num="D."> <text>The name of the pharmacist at the secondary pharmacy who accepted the transmitted prescription order;</text> </paragraph> <paragraph num="E."> <text>The name of the pharmacist at the secondary pharmacy who prepared the prescription order;</text> </paragraph> <paragraph num="F."> <text>The date on which the prescription order was received at the secondary pharmacy; and</text> </paragraph> <paragraph num="G."> <text>The date on which the prepared product was sent to the primary pharmacy if it was sent back to the primary pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Preparation of Stock and Investigational Medications."> <paragraph num="A."> <text>A pharmacist may provide medication for use as stock medication for a licensed health care facility in accordance with applicable laws, if the pharmacy providing the medication also serves as the primary provider of patient specific medication for the facility.</text> </paragraph> <paragraph num="B."> <text>A pharmacist may provide medication for use as stock medication for final dispensing or administration by an authorized prescriber who is permitted by law to administer or dispense medication if the pharmacist receives a written stock medication order from the authorized prescriber for each delivery of medication to the authorized prescriber.</text> </paragraph> <paragraph num="C."> <text>A pharmacist may prepare, package, and label investigational drugs not destined for a specific individual at the time of preparation, packaging, and labeling if:</text> <paragraph num="(1)"> <text>The study for which medications are prepared, packaged, and labeled is approved by an institutional review board as defined in federal law; and</text> </paragraph> <paragraph num="(2)"> <text>The pharmacy permit holder ensures that records disclosing the identity of the subject who eventually receives the medication are:</text> <paragraph num="(a)"> <text>Received by a pharmacist on duty at the pharmacy within 30 days after being provided to a patient; and</text> </paragraph> <paragraph num="(b)"> <text>Maintained in the pharmacy.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Permit and Quality Assurance."> <paragraph num="A."> <text>The permit holder of a pharmacy which prepares patient specific prescriptions as a secondary pharmacy such that these prescriptions account for 5 percent or more of the pharmacy's total number of prescriptions filled shall submit to the Board of Pharmacy, for approval by the Board or a designee of the Board, a plan detailing the steps it has taken to ensure the safety and quality of prescriptions filled as a secondary pharmacy.</text> </paragraph> <paragraph num="B."> <text>The plan under §A of this regulation shall include:</text> <paragraph num="(1)"> <text>Measures to be taken to comply with State and federal laws;</text> </paragraph> <paragraph num="(2)"> <text>The method by which each pharmacist responsible for each prescription is identified in the records;</text> </paragraph> <paragraph num="(3)"> <text>Measures taken to maintain the security, integrity, and confidentiality of patient records; and</text> </paragraph> <paragraph num="(4)"> <text>The establishment and maintenance of a quality assurance program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in Regulation .06 of this chapter, a permit holder of a pharmacy shall obtain manufacturing and distribution permits in order to compound or package medication that is not prepared as a prescription destined for a specific patient, but is forwarded to another pharmacy, authorized prescriber, licensed distributor, or other person or entity.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 4, 1979 (6:9 Md. R. 728)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04, Transfer of Prescriptions Between Pharmacies repealed effective June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 — .09 Transfer and Outsourcing of Prescriptions and Prescription Orders adopted effective June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 recodified to Regulation .07 effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 recodified to Regulation .08 effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 recodified to Regulation .09 effective September 29, 2025 (Md. R. 956)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 recodified to Regulation .10 effective September 29, 2025 (Md. R. 956)</annotation> </annotations> </chapter> <chapter num="05" heading="Pharmacy Security"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Emergency” means an event such as a fire, water leak, electrical failure, public disaster, or catastrophe which may impact the prescription area.</text> </paragraph> <paragraph num="(2)"> <text>“Means of access” means the manner of entry into the secure prescription area.</text> </paragraph> <paragraph num="(3)"> <text>“Prescription area” means the portion of an establishment for which a pharmacy permit has been issued which contains:</text> <paragraph num="(a)"> <text>Patient records;</text> </paragraph> <paragraph num="(b)"> <text>Prescription devices; and</text> </paragraph> <paragraph num="(c)"> <text>Prescription drugs.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Prescription Area."> <paragraph num="A."> <text>The pharmacy permit holder shall:</text> <paragraph num="(1)"> <text>Ensure that the prescription area:</text> <paragraph num="(a)"> <text>Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and</text> </paragraph> <paragraph num="(b)"> <text>Permits reasonable communication between the pharmacist and the public when the pharmacy is open;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide a means of securing the prescription area;</text> </paragraph> <paragraph num="(3)"> <text>Prevent an individual from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services;</text> </paragraph> <paragraph num="(4)"> <text>Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and</text> </paragraph> <paragraph num="(5)"> <text>Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The pharmacist shall:</text> <paragraph num="(1)"> <text>Secure the prescription area and its contents in order that the pharmacy permit holder or the pharmacy permit holder's agent may:</text> <paragraph num="(a)"> <text>Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and</text> </paragraph> <paragraph num="(b)"> <text>Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have sole possession of a means of access to the pharmacy, except in emergencies; and</text> </paragraph> <paragraph num="(3)"> <text>Establish a means of access for use in an emergency when the pharmacist is not available to access the prescription area.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Security.</text> <paragraph num="(1)"> <text>A pharmacy shall be secure from unauthorized entry as follows:</text> <paragraph num="(a)"> <text>Access from outside the premises shall be:</text> <paragraph num="(i)"> <text>Kept to a minimum; and</text> </paragraph> <paragraph num="(ii)"> <text>Well controlled;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The outside perimeter of the premises shall be well lit; and</text> </paragraph> <paragraph num="(c)"> <text>Entry into areas where prescription drugs or devices and patient records are stored shall be limited to authorized personnel.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pharmacy shall be equipped with:</text> <paragraph num="(a)"> <text>An alarm system to detect entry after hours;</text> </paragraph> <paragraph num="(b)"> <text>A security system that provides protection against theft and diversion;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;</text> </paragraph> <paragraph num="(d)"> <text>An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;</text> </paragraph> <paragraph num="(e)"> <text>A security system to protect the integrity and confidentiality of data and documents limited to authorized personnel; and</text> </paragraph> <paragraph num="(f)"> <text>A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, the Division of Drug Control, or federal and other State law enforcement officials.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Pharmacy Operation."> <paragraph num="A."> <text>A pharmacist shall be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation.</text> </paragraph> <paragraph num="B."> <text>If the prescription area is not open the same hours as the establishment, the pharmacy permit holder shall prominently display signs indicating the business hours of the prescription area.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Records."> <paragraph num="A."> <text>A pharmacy permit holder shall:</text> <paragraph num="(1)"> <text>Prevent unauthorized disclosure or loss by securing all patient records;</text> </paragraph> <paragraph num="(2)"> <text>Designate personnel with authorized access to computerized patient records; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain current computerized records in a manner which permits reconstruction within 48 hours, except:</text> <paragraph num="(a)"> <text>In an emergency as defined in Regulation .01 of this chapter, or</text> </paragraph> <paragraph num="(b)"> <text>With the prior approval of the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy permit holder may store patient records away from the prescription area in a manner that prevents unauthorized disclosure or loss.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Security Responsibility."> <paragraph num="A."> <text>The pharmacy permit holder is responsible for ensuring that pharmacists, employees, and others who enter the pharmacy:</text> <paragraph num="(1)"> <text>Know and abide by the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Maintain those measures necessary to ensure this chapter’s enforcement;</text> </paragraph> <paragraph num="(3)"> <text>Report theft or significant loss of controlled dangerous substances to the:</text> <paragraph num="(a)"> <text>Board;</text> </paragraph> <paragraph num="(b)"> <text>Local police;</text> </paragraph> <paragraph num="(c)"> <text>Office of Controlled Substances Administration; and</text> </paragraph> <paragraph num="(d)"> <text>U.S. Drug Enforcement Administration; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Report theft of non-controlled prescription drugs or devices to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether a loss is significant pursuant to §A(3) of this regulation, the pharmacy permit holder shall consider at least the following factors:</text> <paragraph num="(1)"> <text>The actual quantity of controlled dangerous substances lost in relation to the type of business;</text> </paragraph> <paragraph num="(2)"> <text>The specific controlled dangerous substances lost;</text> </paragraph> <paragraph num="(3)"> <text>Whether the loss of the controlled dangerous substances can be associated with access to those controlled dangerous substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving controlled dangerous substances;</text> </paragraph> <paragraph num="(4)"> <text>A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;</text> </paragraph> <paragraph num="(5)"> <text>Whether the specific controlled dangerous substances are likely candidates for diversion, if known; and</text> </paragraph> <paragraph num="(6)"> <text>Local trends and other indicators of the diversion potential of the missing controlled dangerous substances, if known.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 25, 1980 (7:15 Md. R. 1425)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Security of a Pharmacy Facility, repealed and new chapter, Pharmacy Security, adopted effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 2010 (37:10 Md. R. 722); May 20, 2019 (46:10 Md. R. 489)</annotation> </annotations> </chapter> <chapter num="06" heading="Reporting Pharmacist's, Pharmacy Intern's, and Pharmacy Technician's Mailing Address and Location of Employment"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to each pharmacist, pharmacy intern, and pharmacy technician licensed or registered by the Maryland Board of Pharmacy.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In these regulations, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Mailing address” means the address the pharmacist or pharmacy technician specifies that the Board use when communicating with the pharmacist or pharmacy technician.</text> </paragraph> <paragraph num="(3)"> <text>“Primary employment location” means the establishment where the pharmacist or pharmacy technician is employed on a regular basis or works most often.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Mailing Address."> <paragraph num="A."> <text>Each licensed pharmacist, pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharmacy intern’s, or pharmacy technician’s current mailing address on the pharmacist’s, pharmacy intern’s, or pharmacy technician’s biennial license or registration renewal form.</text> </paragraph> <paragraph num="B."> <text>The mailing address:</text> <paragraph num="(1)"> <text>May be the pharmacist’s residence address;</text> </paragraph> <paragraph num="(2)"> <text>Shall be the pharmacy intern’s residence address; or</text> </paragraph> <paragraph num="(3)"> <text>Shall be the pharmacy technician’s residence address.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Within 30 days of the date a pharmacist, pharmacy intern, or pharmacy technician changes the pharmacist’s, pharmacy intern’s, or pharmacy technician’s mailing address, the pharmacist, pharmacy intern, or pharmacy technician shall notify the Board in writing of any change in the information in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Place of Employment."> <paragraph num="A."> <text>This regulation applies only to pharmacists, pharmacy interns, and pharmacy technicians employed in Maryland.</text> </paragraph> <paragraph num="B."> <text>Each licensed pharmacist, registered pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharmacy intern’s, or pharmacy technician’s place of employment on the pharmacist, pharmacy intern, or pharmacy technician biennial license or registration renewal form. A pharmacist, pharmacy intern, or pharmacy technician employed at more than one location shall report the primary employment location at the time the renewal form is submitted to the Board.</text> </paragraph> <paragraph num="C."> <text>Within 30 days of a change in the pharmacist’s, pharmacy intern’s, or pharmacy technician’s primary employment location, the pharmacist, pharmacy intern, or pharmacy technician shall notify the Board in writing of any change in the information required by this regulation. If the pharmacist’s, pharmacy intern’s, or pharmacy technician’s primary employment location changes and the pharmacist’s, pharmacy intern’s, or pharmacy technician’s new primary employment location is owned by the same corporation, partnership, or individual owner, the pharmacist, pharmacy intern, or pharmacy technician is not required to report the change except when completing a biennial license or registration renewal form.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Grounds for Disciplinary Action."> <paragraph num="A."> <text>A pharmacist’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information shall constitute grounds for action under Health Occupations Article, §12-313(b)(25), Annotated Code of Maryland, and may, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-313(b)(1), (7), or (8), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A pharmacy technician’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information shall constitute grounds for action under Health Occupations Article, §12-6B-09(25), Annotated Code of Maryland, and may, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-6B-09(2), (7), or (8), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A pharmacy intern’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information:</text> <paragraph num="(1)"> <text>Shall constitute grounds for action under Health Occupations Article, §12-6D-11(18), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>May, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-6D-11(3), (7), or (8), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 25, 1980 (7:15 Md. R. 1425)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Posting of Prescription Prices and Services, repealed effective April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05, Reporting Pharmacist's Mailing Address and Location of Employment, adopted effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05, Reporting Pharmacist's and Pharmacy Technician's Mailing Address and Location of Employment amended effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03, .04, and .05, Reporting Pharmacist's, Pharmacy Intern's, and Pharmacy Technician's Mailing Address and Location of Employment amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> </annotations> </chapter> <chapter num="07" heading="Pharmacy Equipment"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Material safety data sheets” means a list of hazardous chemicals that provides detailed information on each hazardous chemical, including its potential hazardous effects, its physical and chemical characteristics and recommendations for appropriate protective measures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Equipment."> <text>A pharmacy shall have the following equipment to carry out the practice of pharmacy in Maryland:</text> <paragraph num="A."> <text>If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity to a Class A prescription balance; and</text> </paragraph> <paragraph num="B."> <text>A refrigerator and freezer, if applicable, solely for the storage of drugs requiring refrigeration, with a thermometer or a temperature monitoring device.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Additional Equipment."> <text>The pharmacy shall maintain additional equipment to enable it to prepare and dispense prescriptions properly consistent with its scope of practice.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Reference Libraries."> <paragraph num="A."> <text>A pharmacy permit holder shall maintain an adequate reference library to enable it to prepare and dispense prescriptions properly, consistent with its scope of practice.</text> </paragraph> <paragraph num="B."> <text>A pharmacy permit holder shall maintain a library of reference sources appropriate to the type of pharmacy practice at that particular location. A pharmacy permit holder shall include in the pharmacy's library current material regarding the technical, clinical, and professional aspects of practice with emphasis in the area in which the pharmacy specializes.</text> </paragraph> <paragraph num="B-1."> <text>A pharmacy permit holder may utilize websites and electronic references created by established medical publishers which are recognized as standard for a particular type of pharmacy practice as a supplement to its printed library.</text> </paragraph> <paragraph num="C."> <text>A pharmacy permit holder shall maintain a library containing reference sources that:</text> <paragraph num="(1)"> <text>Enable the pharmacist to compound medications in a safe and effective manner;</text> </paragraph> <paragraph num="(2)"> <text>List the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>List the therapeutic usage and dosages of medications dispensed by the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>List the therapeutic equivalents for medications; and</text> </paragraph> <paragraph num="(5)"> <text>Provide guidelines for the counseling of patients.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A pharmacy permit holder that specializes in nuclear or parenteral prescriptions may limit the library it maintains pursuant to §B of this regulation to the pharmacy permit holder's area of specialization.</text> </paragraph> <paragraph num="E."> <text>A pharmacy permit holder shall maintain material safety data sheets, if applicable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-403, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 21, 1980 (7:6 Md. R. 608)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective September 10, 1984 (11:18 Md. R. 1585)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 19, 1990 (17:3 Md. R. 298)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective August 30, 2004 (31:17 Md. R. 1312)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective September 29, 2025 (52:19 Md. R. 956)</annotation> </annotations> </chapter> <chapter num="08" heading="Information Required on Prescriptions or Patient Drug Profiles"> <regulation prefix="Regulation" num=".01" heading="Information Required on All Original and Refill Prescriptions or Patient Drug Profiles or Computerized Patient Drug Records."> <text>In addition to the information required by law on every prescription, patient drug profile, or computerized patient drug record, the following information shall be legibly entered on all original and refill prescriptions or patient drug profiles or computerized patient drug records:</text> <paragraph num="A."> <text>The date of filling or refilling;</text> </paragraph> <paragraph num="B."> <text>The initials of, or other identifying symbol for:</text> <paragraph num="(1)"> <text>The pharmacist responsible for filling or refilling the prescription; and</text> </paragraph> <paragraph num="(2)"> <text>The data-entry pharmacy technician involved in the dispensing process.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Access to Records."> <text>The information required in Regulation .01 of this chapter shall be readily retrievable for inspection during business hours by authorized personnel.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 6, 1981 (8:3 Md. R. 227)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 15, 1982 (9.5 Md. R. 527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> </annotations> </chapter> <chapter num="09" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all licensees, permit holders, registrants, or applicants for licenses or permits issued by the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Pharmacist Fees.</text> <paragraph num="(1)"> <text>Pharmacist examination fee — $150;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacist reciprocity fee — $300;</text> </paragraph> <paragraph num="(3)"> <text>Pharmacist renewal fee — $225;</text> </paragraph> <paragraph num="(4)"> <text>Pharmacist reinstatement fee for up to 2 years after license expiration, payable in addition to renewal fee — $300; and</text> </paragraph> <paragraph num="(5)"> <text>Pharmacist reinstatement fee for more than 2 years after license expiration, payable in addition to renewal fee — $315.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pharmacy Fees.</text> <paragraph num="(1)"> <text>Pharmacy initial fee — $700;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy renewal fee — $500; and</text> </paragraph> <paragraph num="(3)"> <text>Pharmacy — late fee (payable if renewal fee is received between May 2 and June 30) — $200; and</text> </paragraph> <paragraph num="(4)"> <text>Pharmacy reinstatement fee (payable if renewal fee is received after June 30) — $550.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Distributor Fees.</text> <paragraph num="(1)"> <text>Distributor initial fee — 1,750;</text> </paragraph> <paragraph num="(2)"> <text>Distributor renewal fee — $1,750; and</text> </paragraph> <paragraph num="(3)"> <text>Distributor reinstatement fee after May 31 — $1,500.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Pharmacy Technician Fees.</text> <paragraph num="(1)"> <text>Pharmacy technician registration fee — $45;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy technician renewal fee — $45;</text> </paragraph> <paragraph num="(3)"> <text>Pharmacy technician reinstatement fee — $45;</text> </paragraph> <paragraph num="(4)"> <text>Review of pharmacy technician training programs submitted to the Board for approval — $100; and</text> </paragraph> <paragraph num="(5)"> <text>Review of pharmacy technician training programs submitted to the Board for approval that include a didactic portion that is comprised entirely of a didactic program that has already been approved by the Board — no charge.</text> </paragraph> </paragraph> <paragraph num="D-1."> <text>Pharmacy Intern Fees.</text> <paragraph num="(1)"> <text>Pharmacy intern registration fee — $45; and</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy intern renewal fee — $45.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Miscellaneous Fees.</text> <paragraph num="(1)"> <text>Duplicate registration fee — $10;</text> </paragraph> <paragraph num="(2)"> <text>Duplicate pharmacist license fee — $30;</text> </paragraph> <paragraph num="(2-1)"> <text>Duplicate pharmacy permit fee — $10;</text> </paragraph> <paragraph num="(2-2)"> <text>Duplicate wholesale distributor permit fee — $30;</text> </paragraph> <paragraph num="(3)"> <text>Written verification of good standing fee — $25;</text> </paragraph> <paragraph num="(4)"> <text>Returned check fee — $35;</text> </paragraph> <paragraph num="(5)"> <text>Roster printed on labels fee — $150; and</text> </paragraph> <paragraph num="(6)"> <text>Failure to maintain current address fee — $25.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Pharmacy. Licensees, registrants, and applicants shall be notified of the change.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205, 12-206, 12-302, 12-303, 12-305, 12-308, 12-310, 12-404, 12-407, 12-601,12-6B-02, 12-6B-03, 12-6B-04, 12-6B-07, 12-6C-03, 12-6C-04, 12-6C-05, 12-6C-06, 12-6D-05, 12-6D-06, and 12-6D-09, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1981 (8:8 Md. R. 721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.03 adopted as an emergency provision effective July 1, 1992 (19:12 Md. R. 1131); adopted permanently effective October 1, 1992 (19:15 Md. R. 1391)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); amended permanently effective January 14, 1999 (26:1 Md. R. 24)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 1, 1999 (26:22 Md. R. 1693)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective June 6, 1997 (24:13 Md. R. 928); amended permanently effective September 22, 1997 (24:19 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective July 4, 1994 (21:13 Md. R. 1158)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted as an emergency provision effective February 1, 2002 (29:3 Md. R. 213); adopted permanently effective June 10, 2002 (29:11 Md. R. 889)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 14, 2002 (29:20 Md. R. 1589); January 28, 2008 (35:2 Md. R. 127); February 1, 2010 (36:26 Md. R. 1995); December 21, 2015 (42:25 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); amended permanently effective March 3, 2003 (30:4 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective May 20, 2019 (46:10 Md. R. 489)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K, L amended effective November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 amended as an emergency provision effective June 28, 1996 (23:15 Md. R. 1083); amended permanently effective October 7, 1996 (23:20 Md. R. 1424)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); amended permanently effective January 14, 1999 (26:1 Md. R. 24)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 1, 1999 (26:22 Md. R. 1693); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed effective December 21, 2015 (42:25 Md. R. 1543)</annotation> </annotations> </chapter> <chapter num="10" heading="Pharmacist, Pharmacy Intern, and Pharmacy Technician Code of Conduct"> <regulation prefix="Regulation" num=".01" heading="Patient Safety and Welfare."> <paragraph num="A."> <text>A pharmacist shall:</text> <paragraph num="(1)"> <text>Abide by all federal and State laws relating to the practice of pharmacy and the dispensing, distribution, storage, and labeling of drugs and devices, including but not limited to:</text> <paragraph num="(a)"> <text>United States Code, Title 21,</text> </paragraph> <paragraph num="(b)"> <text>Health-General Article, Titles 21 and 22, Annotated Code of Maryland,</text> </paragraph> <paragraph num="(c)"> <text>Health Occupations Article, Title 12, Annotated Code of Maryland,</text> </paragraph> <paragraph num="(d)"> <text>Criminal Law Article, Title 5, Annotated Code of Maryland, and</text> </paragraph> <paragraph num="(e)"> <text>COMAR 10.19.03;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Verify the accuracy of the prescription before dispensing the drug or device if the pharmacist has reason to believe that the prescription contains an error; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain proper sanitation, hygiene, biohazard precautions, and infection control when performing tasks in the prescription process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacist may not:</text> <paragraph num="(1)"> <text>Engage in conduct which departs from the standard of care ordinarily exercised by a pharmacist;</text> </paragraph> <paragraph num="(2)"> <text>Practice pharmacy under circumstances or conditions which prevent the proper exercise of professional judgment; or</text> </paragraph> <paragraph num="(3)"> <text>Engage in unprofessional conduct.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Therapeutic Interchange.</text> <paragraph num="(1)"> <text>A pharmacist may not perform a therapeutic interchange without the prior approval of the authorized prescriber except as provided in §C(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A pharmacist who provides a pharmacy service to a patient of a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a resident of a comprehensive care or extended care facility, as defined in COMAR 10.07.02.01B, may perform a therapeutic interchange without the prior approval of the authorized prescriber if the governing body of the hospital, comprehensive care facility, or extended care facility has established procedures for therapeutic interchange.</text> </paragraph> <paragraph num="(3)"> <text>This section does not permit any act not otherwise authorized by Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Compensation."> <text>A pharmacy technician, pharmacy intern, or a pharmacist may not fraudulently seek or accept compensation for a pharmacy product or service not provided.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Patient Privacy."> <paragraph num="A."> <text>The pharmacy technician, pharmacy intern, pharmacist, and pharmacy permit holder shall ensure confidentiality in creating, storing, accessing, transferring, and disposing of a patient record.</text> </paragraph> <paragraph num="B."> <text>A pharmacy technician, pharmacy intern, or pharmacist may not disclose identifiable information contained in a patient’s medical record:</text> <paragraph num="(1)"> <text>Without the patient's consent;</text> </paragraph> <paragraph num="(2)"> <text>Without order or direction of a court; or</text> </paragraph> <paragraph num="(3)"> <text>Unless the disclosure is authorized pursuant to Health-General Article, §§4-301 — 4-307, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Competence."> <text>A pharmacy technician, pharmacy intern, or a pharmacist shall:</text> <paragraph num="A."> <text>Maintain knowledge of the current pharmacy and drug laws and health and sanitation laws relevant to the practice of pharmacy; and</text> </paragraph> <paragraph num="B."> <text>Provide a pharmaceutical service only within the scope of the pharmacy technician’s, pharmacy intern’s, or pharmacist’s training and education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Duty to Report."> <paragraph num="A."> <text>Except when the conduct in question includes drug or alcohol abuse or dependency, a pharmacy technician, pharmacy intern, or pharmacist shall report to the Board:</text> <paragraph num="(1)"> <text>Conduct which violates a statute or regulation pertaining to the practice of pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>Conduct by a pharmacy technician, pharmacy intern, or pharmacist that deceives, defrauds, or harms the public; and</text> </paragraph> <paragraph num="(3)"> <text>The unauthorized practice of pharmacy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy technician, pharmacy intern, or pharmacist shall report to the pharmacist rehabilitation committee, as defined in Health Occupations Article, §12-317, Annotated Code of Maryland, conduct by a pharmacist technician, pharmacy intern, or pharmacist that involves drug or alcohol abuse or dependency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Discrimination, Harassment, and Sexual Misconduct."> <paragraph num="A."> <text>In the practice of pharmacy, a pharmacy technician, pharmacy intern, or pharmacist may not:</text> <paragraph num="(1)"> <text>Discriminate based on age, gender, race, ethnicity, national origin, religion, sexual orientation, disability, socioeconomic status, or other basis as proscribed by law; or</text> </paragraph> <paragraph num="(2)"> <text>Sexually harass a patient, coworker, employee, or supervisee, which includes but is not limited to an unwanted, deliberate, or repeated comment, gesture, or physical contact of a sexual nature.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Sexual Misconduct. A pharmacy technician, pharmacy intern, or pharmacist may not:</text> <paragraph num="(1)"> <text>Dispense or offer to dispense a prescription drug or device in exchange for:</text> <paragraph num="(a)"> <text>A sexual act such as anal intercourse, analingus, cunnilingus, fellatio, or vaginal intercourse as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland, or</text> </paragraph> <paragraph num="(b)"> <text>Sexual contact such as the intentional touching of an intimate part of an individual's body, whether clothed or unclothed, for the purpose of sexual arousal, gratification, abuse of either party, or penetration as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Engage in sexual behavior including but not limited to a sexual act or sexual contact as specified in §B(1)(a) of this regulation, with a client or patient:</text> <paragraph num="(a)"> <text>In the context of a professional evaluation, treatment, procedure, or other service to the client or patient, regardless of the setting in which the professional service is provided, or</text> </paragraph> <paragraph num="(b)"> <text>Under the pretense of diagnostic or therapeutic intent or benefit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Sexual contact does not include an act commonly expressive of familial or friendly affection.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disposition and Return of a Prescription Drug or Device."> <paragraph num="A."> <text>A pharmacist may accept the return of a properly labeled and properly sealed manufacturer’s package or individual unit dose of a drug or device that the pharmacist determines to have been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy.</text> </paragraph> <paragraph num="B."> <text>A pharmacist may not:</text> <paragraph num="(1)"> <text>Return to the pharmacy's stock or offer for sale a prescribed drug or device that has been previously sold and has left the pharmacy's possession except as provided in §A of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Sell, give away, or otherwise dispose of a drug, drug accessory, chemical, or device if the pharmacist knows or should know that the drug, drug accessory, chemical, or device is to be used in an illegal activity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy technician or pharmacy intern may not accept the return of prescription drugs or devices from a patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Refusing to Dispense a Controlled Substance."> <paragraph num="A."> <text>If, based on generally accepted professional standards for the practice of pharmacy, a pharmacist has reason to believe, or should have reason to believe, that a prescription for a controlled dangerous substance was not issued for a legitimate medical purpose in the usual course of the prescriber's practice, the pharmacist may not dispense the controlled dangerous substance until the pharmacist:</text> <paragraph num="(1)"> <text>Consults with the prescriber; and</text> </paragraph> <paragraph num="(2)"> <text>Verifies the medical legitimacy of the prescription.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If, after consulting with the prescriber, and based on generally accepted professional standards for the practice of pharmacy, a pharmacist has reason to believe that the prescription for a controlled dangerous substance was not issued for a legitimate medical purpose in the usual course of the prescriber's practice, the pharmacist shall:</text> <paragraph num="(1)"> <text>Refuse to dispense the drug; and</text> </paragraph> <paragraph num="(2)"> <text>Report the incident to the regulatory board that licenses the prescriber.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Sanctions."> <paragraph num="A."> <text>The Board may take action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license if the licensee commits a violation of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Board may take action to reprimand a registrant, place the registrant on probation, or suspend or revoke the registrant's registration if the registrant commits a violation of this chapter.</text> </paragraph> <paragraph num="C."> <text>The Board may impose a monetary penalty as authorized under Health Occupations Article, §§12-314, 12-410, and 12-6B-10, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Whole or Substantial Ownership of a Pharmacy by an Authorized Prescriber."> <paragraph num="A."> <text>In this regulation, “owned wholly or substantially” means ownership of 10 percent or more of a pharmacy.</text> </paragraph> <paragraph num="B."> <text>A pharmacist may not associate as a partner, coowner, or employee of a pharmacy that is owned wholly or substantially by an authorized prescriber or group of authorized prescribers.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 12-205, and 12-601, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 3, 1981 (8:15 Md. R. 1307)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Standards of Pharmacy Practice, repealed and new chapter, Pharmacist Code of Conduct, adopted effective July 12, 1999 (26:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 12, 2001 (28:22 Md. R. 1937)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, C amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C adopted effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective February 1, 2016 (43:2 Md. R. 127)</annotation> </annotations> </chapter> <chapter num="11" heading="Disciplinary Sanctions, Monetary Penalties, and Civil Fines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of disciplinary sanctions, monetary penalties, and civil fines for violations of Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(3)"> <text>“Civil fine” means a fine assessed by the Board against a person for practicing without an active license, pharmacy permit, registration, or wholesale distributor permit.</text> </paragraph> <paragraph num="(4)"> <text>“License” means, unless the context requires otherwise, a license issued by the Board to practice pharmacy.</text> </paragraph> <paragraph num="(5)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(6)"> <text>“Pharmacy permit” means a permit issued by the Board to establish and operate a pharmacy.</text> </paragraph> <paragraph num="(7)"> <text>“Registration” means, unless the context requires otherwise, a registration issued by the Board to practice pharmacy as a registered pharmacy intern under the direct supervision of a licensed pharmacist or perform delegated pharmacy acts as a registered pharmacy technician under the direct supervision of a licensed pharmacist.</text> </paragraph> <paragraph num="(8)"> <text>“Sanction” means a disciplinary action reprimanding, restricting, suspending, or revoking a license, pharmacy permit, registration, or wholesale distributor permit.</text> </paragraph> <paragraph num="(9)"> <text>“Wholesale distributor permit” means a permit issued by the Board to establish and operate a wholesale distributor as defined in the Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of Disciplinary Sanctions or Monetary Penalties Generally."> <paragraph num="A."> <text>After a hearing pursuant to Health Occupations Article, §12-315, 12-601, 12-6B-09, or 12-6D-11, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy technician, pharmacy intern, pharmacist, or wholesale distributor permit holder pursuant to Health Occupations Article, §12-314, 12-6B-10, 12-6C-11, or 12-6D-12, Annotated Code of Maryland, instead of or in addition to:</text> <paragraph num="(1)"> <text>Reprimanding the registrant, licensee, or wholesale distributor permit holder;</text> </paragraph> <paragraph num="(2)"> <text>Placing the registrant, licensee, or wholesale distributor permit holder on probation;</text> </paragraph> <paragraph num="(3)"> <text>Suspending a registration, license, or wholesale distributor permit; or</text> </paragraph> <paragraph num="(4)"> <text>Revoking a registration, license, or wholesale distributor permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>After a hearing pursuant to Health Occupations Article, §12-411, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy permit holder pursuant to Health Occupations Article, §12-410, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Instead of or in addition to suspending the pharmacy permit; or</text> </paragraph> <paragraph num="(2)"> <text>In addition to revoking the pharmacy permit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder may agree to a surrender of a registration, license, pharmacy permit, or wholesale distributor permit or a consent order with terms, sanction, and penalty agreed to by the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder.</text> </paragraph> <paragraph num="D."> <text>Nothing in this chapter prohibits the Board from staying any period of nonactive suspension.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Interns."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacists."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>The Board may not consider a petition for reinstatement of a license that has been revoked until at least 5 years have passed from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Technicians."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>The Board may not consider a petition for reinstatement of a registration that has been revoked until at least 5 years have passed from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Permit Holder."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a pharmacy permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>The Board may not consider a petition for reinstatement of a pharmacy permit that has been revoked until at least 5 years have passed from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Wholesale Distributor Permit Holder."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a wholesale distributor permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>The Board may not consider a petition for reinstatement of a wholesale distributor permit that has been revoked until at least 5 years have passed from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction and Penalty."> <paragraph num="A."> <text>Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>The licensee’s, registrant’s, or permit holder’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The licensee, registrant, or permit holder self-reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The licensee’s, registrant’s, or permit holder’s full and voluntary admission of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The licensee, registrant, or permit holder implemented remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The licensee, registrant, or permit holder made a timely good-faith effort to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to public or adverse impact; and</text> </paragraph> <paragraph num="(i)"> <text>The licensee’s, registrant’s, or permit holder’s conduct was an isolated incident and not likely to recur; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>The licensee, registrant, or permit holder has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The licensee, registrant, or permit holder was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the patient or customer;</text> </paragraph> <paragraph num="(g)"> <text>The licensee, registrant, or permit holder attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(h)"> <text>Previous attempts at rehabilitation of the licensee, registrant, or permit holder were unsuccessful; and</text> </paragraph> <paragraph num="(i)"> <text>The licensee, registrant, or permit holder committed the violation under the guise of treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="C."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Civil Fines to Pharmacists, Pharmacy Technicians, and Pharmacy Permit Holders."> <paragraph num="A."> <text>Practicing on an Expired License. The Board may assess a civil fine against a pharmacist who practices on an expired license in the amount of $1,000 per month of practice past the expiration date of the license, up to a maximum fine of $50,000.</text> </paragraph> <paragraph num="B."> <text>Working on an Expired Registration. The Board may assess a civil fine against a pharmacy technician or pharmacy intern who works on an expired registration in the amount of $25 per month of practice past the expiration date of the registration, up to a maximum fine of $250.</text> </paragraph> <paragraph num="C."> <text>Operating a Pharmacy on an Expired Permit. The Board may assess a civil fine against a permit holder that operates a pharmacy on an expired permit in the amount of $5,000 per month of operation past the expiration date of the permit, up to a maximum fine of $50,000.</text> </paragraph> <paragraph num="D."> <text>Practicing or Operating Without a License, Registration, or Pharmacy Permit.</text> <paragraph num="(1)"> <text>The Board may assess a civil fine of no less than $5,000 and no more than $50,000 against:</text> <paragraph num="(a)"> <text>An individual who practices pharmacy without a license; or</text> </paragraph> <paragraph num="(b)"> <text>An individual or entity that operates a pharmacy without a permit.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may assess a civil fine of no less than $250 and no more than $50,000 against an individual who works as an unregistered pharmacy technician or unregistered pharmacy intern.</text> </paragraph> <paragraph num="(3)"> <text>Factors in determining the amount of a fine include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The extent to which the individual or entity derived any financial benefit from the unauthorized practice or operation;</text> </paragraph> <paragraph num="(b)"> <text>The willfulness of the unauthorized practice or operation;</text> </paragraph> <paragraph num="(c)"> <text>Actual or potential public harm caused by the unauthorized practice or operation; and</text> </paragraph> <paragraph num="(d)"> <text>The length of time in which the individual or entity engaged in the unauthorized practice or operation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Civil Fines to Wholesale Distributor Permit Holders."> <paragraph num="A."> <text>Operating on an Expired Wholesale Distributor Permit. The Board may assess a civil fine against a permit holder that operates on an expired wholesale distributor permit in the following amount:</text> <paragraph num="(1)"> <text>A maximum of $10,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were less than $10,000,000, up to a maximum fine of $500,000; or</text> </paragraph> <paragraph num="(2)"> <text>A maximum of $25,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were $10,000,000 or more, up to a maximum fine of $500,000.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Practicing Without a License.</text> <paragraph num="(1)"> <text>The Board may assess a civil fine of no less than $10,000 and no more than $500,000 against an individual or entity that operates a wholesale distributor without a license.</text> </paragraph> <paragraph num="(2)"> <text>Factors in determining the amount of a fine include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The size of the wholesale distributor;</text> </paragraph> <paragraph num="(b)"> <text>The gravity of the violation for which the fine is to be imposed;</text> </paragraph> <paragraph num="(c)"> <text>The good faith of the wholesale distributor;</text> </paragraph> <paragraph num="(d)"> <text>Any previous violations by the wholesale distributor;</text> </paragraph> <paragraph num="(e)"> <text>Actual or potential public harm caused by the unauthorized operation; and</text> </paragraph> <paragraph num="(f)"> <text>The length of time in which the entity engaged in the unauthorized operation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Payment of a Penalty."> <paragraph num="A."> <text>A licensee, registrant, or permit holder shall pay to the Board a penalty imposed under this chapter within 30 days of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §12-316, 12-412, or 12-601, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board pursuant to this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee, registrant, or permit holder fails to pay, in whole or in part, a penalty imposed by the Board pursuant to this chapter, the Board may not restore, reinstate, or renew a license, registration, or permit until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>Deposit of Monies.</text> <paragraph num="(1)"> <text>The Board shall pay monies collected pursuant to this chapter, except for civil fines collected under Regulation .09 of this chapter, into the State's General Fund.</text> </paragraph> <paragraph num="(2)"> <text>Civil Fines.</text> <paragraph num="(a)"> <text>The Board shall pay civil fines collected under Regulation .09 of this chapter into the State Board of Pharmacy Fund, in accordance with Health Occupations Article, §12-707(e)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall pay civil fines collected under Regulation .10 of this chapter into the State’s General Fund.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 12-313, 12-314, 12-409, 12-410, 12-601, 12-6B-09, 12-6B-10, 12-6C-11, 12-6D-11, 12-6D-12, and 12-707, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 4, 1984 (11:11 Md. R. 962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 20, 2003 (30:1 Md. R. 25); January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299); January 20, 2003 (30:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 20, 2003 (30:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 20, 2003 (30:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, D amended and .06E, F adopted effective January 20, 2003 (30:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, D amended effective January 20, 2003 (30:1 Md. R. 25)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 repealed and new Regulations .01—.11 adopted effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted effective July 1, 2015 (42:7 Md. R. 569)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, D amended effective July 1, 2015 (42:7 Md. R. 569)</annotation> </annotations> </chapter> <chapter num="12" heading="Removal of Expired Medications"> <regulation prefix="Regulation" num=".01" heading="Manufacturer's Expiration Date."> <paragraph num="A."> <text>A wholesale distributor, pharmacist, or pharmacy shall distribute or hold for sale medications bearing a manufacturer's expiration date pursuant to 21 C.F.R. §211.137.</text> </paragraph> <paragraph num="B."> <text>A wholesale distributor, pharmacist, or pharmacy shall have adequate and credible provisions for return of outdated drugs, including but not limited to partials, through its wholesaler distributor or reverse distributor.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2010 (37:10 Md. R. 722)</annotation> </annotations> </chapter> <chapter num="13" heading="Reinstatement of Expired Licenses for Pharmacists"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“MPJE” means the Multistate Pharmacy Jurisprudence Examination.</text> </paragraph> <paragraph num="(3)"> <text>“NAPLEX” means the North American Pharmacist Licensure Examination.</text> </paragraph> <paragraph num="(4)"> <text>“Reinstatement” means renewal of a license after the license has expired.</text> </paragraph> <paragraph num="(5)"> <text>“Renewal” means renewing a license before the date of expiration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Reinstatement Fee."> <text>The reinstatement fee authorized by Health Occupations Article, §12-310(a)(2), Annotated Code of Maryland, shall be as determined in COMAR 10.34.09.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Reinstatement Requirements."> <paragraph num="A."> <text>General Requirements. A pharmacist who wishes to reinstate an expired license to practice pharmacy shall:</text> <paragraph num="(1)"> <text>Provide evidence of the completed amount of approved continuing education required by the Board in COMAR 10.34.18 in conjunction with the reinstatement application;</text> </paragraph> <paragraph num="(2)"> <text>Provide evidence of good standing in any other state in which the pharmacist has been licensed, if applicable; and</text> </paragraph> <paragraph num="(3)"> <text>Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Specific Requirements.</text> <paragraph num="(1)"> <text>The Board:</text> <paragraph num="(a)"> <text>May reinstate the license of a pharmacist who has actively engaged in the practice of pharmacy in Maryland after the expiration of the pharmacist's license if the pharmacist:</text> <paragraph num="(i)"> <text>Meets the requirements of §A of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Pays the pharmacist reinstatement fee established in COMAR 10.34.09.02;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May bring charges against a pharmacist who has practiced without a license; and</text> </paragraph> <paragraph num="(c)"> <text>When determining sanctions for practicing pharmacy without a license under §B(1) of this regulation, shall consider:</text> <paragraph num="(i)"> <text>The length of time during which the pharmacist practiced without a license; and</text> </paragraph> <paragraph num="(ii)"> <text>Any violations of Health Occupations Article, Title 12, Annotated Code of Maryland, committed by the pharmacist during the period of unlicensed practice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired less than 2 years before applying for reinstatement, shall meet the requirements of §A of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>A pharmacist licensed in another state and actively engaged in the practice of pharmacy in that state, whose Maryland license expired less than 2 years before applying for license reinstatement, shall meet the requirements of §A of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>A pharmacist licensed in another state and actively engaged in the practice of pharmacy in that state, whose Maryland license expired 2 years but less than 5 years before applying for license reinstatement, shall:</text> <paragraph num="(a)"> <text>Meet the requirements of §A of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Submit evidence satisfactory to the Board which documents the applicant's pharmacy experience during the 2 years immediately preceding the date of the applicant's reinstatement application; and</text> </paragraph> <paragraph num="(c)"> <text>Pass the MPJE.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired more than 2 years but less than 5 years before applying for reinstatement, shall:</text> <paragraph num="(a)"> <text>Meet the requirements of §A of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Pass the MPJE.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A pharmacist not actively engaged in the practice of pharmacy in another state, whose Maryland license expired more than 5 years but less than 10 years before applying for reinstatement, shall:</text> <paragraph num="(a)"> <text>Meet the requirements of §A of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Pass the MPJE; and</text> </paragraph> <paragraph num="(c)"> <text>Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired 10 or more years before applying for reinstatement, shall:</text> <paragraph num="(a)"> <text>Meet the requirements of §A(2) and (3) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Pass the MPJE;</text> </paragraph> <paragraph num="(c)"> <text>Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist; and</text> </paragraph> <paragraph num="(d)"> <text>Pass the NAPLEX.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Waiver."> <text>The Board may waive any of the requirements set forth in Regulation .03 of this chapter in reinstating a pharmacist's expired license.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 9, 1984 (11:7 Md. R. 625)</annotation> <annotation type="History" subtype="Administrative History">Recodified from COMAR 10.34.15 to 10.34.13</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 5, 1988 (15:18 Md. R. 2152)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 24, 1994 (21:21 Md. R. 1814); November 1, 1999 (26:22 Md. R. 1693); February 17, 2003 (30:3 Md. R. 180); July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299); October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective September 5, 1988 (15:18 Md. R. 2152)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective November 1, 1999 (26:22 Md. R. 1693)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 14, 2002 (29:20 Md. R. 1589); February 17, 2003 (30:3 Md. R. 180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 7, 2022 (49:4 Md. R. 299); emergency status expired effective July 6, 2022</annotation> </annotations> </chapter> <chapter num="14" heading="Opening and Closing of Pharmacies"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Closing of a pharmacy” means a licensed pharmacy will cease operations for more than 7 consecutive days, except when:</text> <paragraph num="(a)"> <text>A licensed pharmacy is destroyed or otherwise rendered inoperable, and the licensed pharmacy is moving its operations to a temporary site in accordance with the Board’s regulations; or</text> </paragraph> <paragraph num="(b)"> <text>A licensed pharmacy is undergoing a change of ownership:</text> <paragraph num="(i)"> <text>That will not result in any cessation of pharmacy operations at the location; and</text> </paragraph> <paragraph num="(ii)"> <text>The anticipated new pharmacy permit holder has submitted a change of ownership application to the Board at least 30 days prior to the change of ownership transaction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Operational pharmacy” means a pharmacy that is actively compounding, dispensing, or distributing prescription or nonprescription drugs or devices in accordance with Health Occupations Article, §12-101(p), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Opening a Pharmacy."> <paragraph num="A."> <text>To apply for a pharmacy permit, an applicant shall:</text> <paragraph num="(1)"> <text>Submit an application to the Board on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board an application fee set by the Board in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to an opening inspection, at which time the applicant shall have, at a minimum, the following:</text> <paragraph num="(a)"> <text>If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity;</text> </paragraph> <paragraph num="(b)"> <text>A refrigerator, solely for the storage of medications requiring refrigeration, with a thermometer or a temperature monitoring device;</text> </paragraph> <paragraph num="(c)"> <text>Additional equipment to enable the pharmacy to prepare and dispense prescriptions properly consistent with the pharmacy’s scope of practice;</text> </paragraph> <paragraph num="(d)"> <text>Hot and cold running water;</text> </paragraph> <paragraph num="(e)"> <text>A library of current reference sources, consistent with the pharmacy’s scope of practice, that is accessible to appropriate personnel;</text> </paragraph> <paragraph num="(f)"> <text>A current edition of Maryland Pharmacy Laws;</text> </paragraph> <paragraph num="(g)"> <text>A security system in accordance with COMAR 10.34.05.02; and</text> </paragraph> <paragraph num="(h)"> <text>A pharmacist on the premises during the opening inspection, if prescription drugs are present.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy may not be located in a residence.</text> </paragraph> <paragraph num="C."> <text>A permit holder who has been issued a pharmacy permit by the Board shall, within 60 days following the initial issuance of the pharmacy permit, have and maintain an operational pharmacy.</text> </paragraph> <paragraph num="D."> <text>The Board shall inspect a pharmacy after the initial issuance of a pharmacy permit to ensure that the pharmacy is an operational pharmacy.</text> </paragraph> <paragraph num="E."> <text>If a pharmacy is not an operational pharmacy within 60 days following the initial issuance of a pharmacy permit, the Board shall notify the permit holder of the Board’s intent to rescind the pharmacy permit.</text> </paragraph> <paragraph num="F."> <text>A permit holder who has been notified of the Board’s intent to rescind the pharmacy permit under this regulation shall return the permit to the Board within 10 days of notification, unless the permit holder submits documentation satisfactory to the Board to show that the pharmacy is an operational pharmacy.</text> </paragraph> <paragraph num="G."> <text>If a pharmacy permit has been rescinded under this regulation, the permit holder may reapply if application requirements are met.</text> </paragraph> <paragraph num="H."> <text>The Board may waive any of the requirements set forth in this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notification of Closing of a Pharmacy."> <paragraph num="A."> <text>At least 14 days before a licensed pharmacy’s anticipated date of closing, the pharmacy permit holder shall:</text> <paragraph num="(1)"> <text>Notify the:</text> <paragraph num="(a)"> <text>Board in writing by certified mail, return receipt requested, or hand delivery to the Board’s office, of the day on which the licensed pharmacy will close;</text> </paragraph> <paragraph num="(b)"> <text>Office of Controlled Substances Administration by certified mail, return receipt requested, of the day on which the licensed pharmacy will close;</text> </paragraph> <paragraph num="(c)"> <text>Public by conspicuously posting a notice inside the pharmacy and on the pharmacy’s website of the anticipated day on which the pharmacy will close; and</text> </paragraph> <paragraph num="(d)"> <text>Pharmacy’s customers who pick up a new or refilled prescription via written and verbal communication of the anticipated day on which the licensed pharmacy will close; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Request a closing inspection date.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The notice shall contain the:</text> <paragraph num="(1)"> <text>Anticipated date of closing;</text> </paragraph> <paragraph num="(2)"> <text>Name and location of the pharmacy to which the closing pharmacy will transfer patient prescriptions and records; and</text> </paragraph> <paragraph num="(3)"> <text>Manner in which a patient may request the closing pharmacy to send the patient’s prescriptions and records to an alternative pharmacy of the patient’s choice.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon notification by a pharmacy permit holder of the proposed date on which a licensed pharmacy will close, the Board or its agent shall schedule a closing inspection to be performed within 14 days, excluding federal and State holidays, of the pharmacy’s closing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Notification by Pharmacy Permit Holder of Anticipated Sale of Pharmacy Operations."> <paragraph num="A."> <text>At least 30 days before a licensed pharmacy’s sale or transfer of its pharmacy operations at the permitted establishment, the pharmacy permit holder shall:</text> <paragraph num="(1)"> <text>Notify the:</text> <paragraph num="(a)"> <text>Board in writing by certified mail, return receipt requested, or hand delivery to the Board’s office; and</text> </paragraph> <paragraph num="(b)"> <text>Office of Controlled Substances Administration by certified mail, return receipt requested; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Request a closing inspection of the pharmacy permit holder’s pharmacy inventory and records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The notice shall contain:</text> <paragraph num="(1)"> <text>The anticipated date of the pharmacy permit holder’s sale or transfer of its pharmacy operations; and</text> </paragraph> <paragraph num="(2)"> <text>The name of the anticipated purchaser or transferee of the pharmacy permit holder’s pharmacy operations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon notification by a pharmacy permit holder of the proposed date on which the licensed pharmacy’s operations will be sold or transferred, the Board or its agent shall schedule a closing inspection of the pharmacy permit holder’s inventory and records to be performed within 14 days, excluding State and federal holidays.</text> </paragraph> <paragraph num="D."> <text>In the event the purchaser or transferee of the pharmacy’s operations is not issued a new pharmacy permit by the Board on or prior to the date of the sale or transfer of the pharmacy operations that results in the cessation of pharmacy operations, the existing pharmacy permit holder shall immediately provide notice to the public, posted outside the pharmacy and on the pharmacy’s website, including:</text> <paragraph num="(1)"> <text>The anticipated day on which pharmacy operations may resume; and</text> </paragraph> <paragraph num="(2)"> <text>The pharmacy permit holder’s contact information for patients who wish to transfer prescriptions or records to another licensed pharmacy of the patient’s choice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Required Information and Procedure."> <paragraph num="A."> <text>At the closing inspection of a licensed pharmacy, the pharmacy permit holder shall provide to the Board, or the Board’s agent, information and documentation required by Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The pharmacy permit holder shall remove or completely cover indications that the premises was a pharmacy within 30 days after the date the licensed pharmacy ceases to operate as a pharmacy.</text> </paragraph> <paragraph num="C."> <text>The pharmacy permit holder shall notify prescription drug suppliers to the pharmacy, before ceasing to operate as a pharmacy, of the date that the location will cease to operate as a pharmacy.</text> </paragraph> <paragraph num="D."> <text>The pharmacy permit holder shall notify the public of the date that the pharmacy will cease to operate as a pharmacy by that date.</text> </paragraph> <paragraph num="E."> <text>The pharmacy permit holder shall notify the public of the location to which the patients' records have been transferred, by the date the pharmacy ceases to operate.</text> </paragraph> <paragraph num="F."> <text>If patient records are not transferred, the pharmacy permit holder shall notify the public of the:</text> <paragraph num="(1)"> <text>Location of the patient records;</text> </paragraph> <paragraph num="(2)"> <text>Method by which the patient records shall be maintained; and</text> </paragraph> <paragraph num="(3)"> <text>Procedure by which patients and other authorized individuals or entities may access the patient records.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The pharmacy permit holder shall comply with all federal and State laws and regulations.</text> </paragraph> <paragraph num="H."> <text>If the Board’s agent performs the closing inspection, the Board’s agent shall obtain information and documentation required by Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Information and Documentation Due at the Closing Inspection."> <text>Information and documentation due at the closing inspection shall include:</text> <paragraph num="A."> <text>The exact date on which the pharmacy ceased to operate as a pharmacy;</text> </paragraph> <paragraph num="B."> <text>A copy of the inventory required by the Drug Enforcement Administration;</text> </paragraph> <paragraph num="C."> <text>The pharmacy permit and Maryland Department of Health controlled dangerous substance registration for cancellation;</text> </paragraph> <paragraph num="D."> <text>The names, address, telephone numbers, and Drug Enforcement Administration registration numbers of the persons or business entities to whom any prescription drugs in stock were returned or transferred under Regulation .05 of this chapter and for any prescription files or patient records transferred;</text> </paragraph> <paragraph num="E."> <text>If prescription drugs are destroyed pursuant to Regulation .06 of this chapter, and Regulation .07 of this chapter does not apply to the prescription drugs, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating the:</text> <paragraph num="(1)"> <text>Date, place and manner in which the prescription drugs were destroyed;</text> </paragraph> <paragraph num="(2)"> <text>Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs; and</text> </paragraph> <paragraph num="(3)"> <text>Name, dosage unit, and quantity of each type of prescription drug destroyed;</text> </paragraph> </paragraph> <paragraph num="F."> <text>If any patient records which are not required to be maintained by law, or other documents containing patient information are destroyed, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating:</text> <paragraph num="(1)"> <text>That the documents were destroyed;</text> </paragraph> <paragraph num="(2)"> <text>The date of the destruction of the documents;</text> </paragraph> <paragraph num="(3)"> <text>The name and address of the person who destroyed the documents;</text> </paragraph> <paragraph num="(4)"> <text>That the records or other documents were destroyed in a manner so as to avoid breaches of patients' confidentiality; and</text> </paragraph> <paragraph num="(5)"> <text>The identity of the records destroyed; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>If any patient records or other documents containing patient information are transferred, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating:</text> <paragraph num="(1)"> <text>The date, time, place to which and manner in which the records or other documents were transferred;</text> </paragraph> <paragraph num="(2)"> <text>The names, addresses, and telephone numbers of the persons responsible for transferring the records or other documents;</text> </paragraph> <paragraph num="(3)"> <text>That the records or other documents were transferred in a manner so as to avoid breaches of patients' confidentiality; and</text> </paragraph> <paragraph num="(4)"> <text>The identity of the records transferred.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disposition of Prescription Drugs Other than Controlled Dangerous Substances."> <text>With the exception of controlled dangerous substances, prescription drugs in stock shall be disposed of by one or more of the following means:</text> <paragraph num="A."> <text>Returning them to a distributor or manufacturer; or</text> </paragraph> <paragraph num="B."> <text>Transferring them to another licensed pharmacy, authorized prescriber, or other person or entity approved by the Board or the Division of Drug Control.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disposition of Controlled Dangerous Substances."> <text>The pharmacy permit holder shall comply with the procedures set forth in this chapter in addition to those set forth in COMAR 10.19.03.10C — E governing the disposal of controlled dangerous substances.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-513, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 3, 1984 (11:24 Md. R. 2069)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C adopted effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02E amended effective February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04 repealed and new Regulations .01 — .06 adopted effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 1, 2012 (39:7 Md. R. 493)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 8, 2013 (40:13 Md. R. 1076); June 26, 2023 (50:12 Md. R. 475)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 8, 2013 (40:13 Md. R. 1076); June 26, 2023 (50:12 Md. R.475)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 8, 2013 (40:13 Md. R. 1076)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 8, 2013 (40:13 Md. R. 1076)</annotation> </annotations> </chapter> <chapter num="15" heading="Licensure by Reciprocity"> <regulation prefix="Regulation" num=".01" heading="Requirements."> <paragraph num="A."> <text>An individual applying for licensure as a pharmacist by reciprocity shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the fee as specified in COMAR 10.34.09;</text> </paragraph> <paragraph num="(3)"> <text>Submit to the Board evidence of completion of at least 520 hours of pharmacy experience after graduation from a school or college of pharmacy approved by the Board or accredited by the American Council on Pharmaceutical Education;</text> </paragraph> <paragraph num="(4)"> <text>Pass the MPJE; and</text> </paragraph> <paragraph num="(5)"> <text>Pass the exam of oral English competency described in COMAR 10.34.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall waive the requirements of §A(5) of this regulation if the candidate for licensure by reciprocity submits to the Board written documentation that the candidate has passed an equivalent oral English competency exam in another state that was required by the other state's licensing procedures.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 3, 1984 (11:24 Md. R. 2069)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.34.18 to 10.34.15</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 16, 1990 (17:7 Md. R. 849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective April 6, 1998 (25:7 Md. R. 527)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 7, 2022 (49:4 Md. R. 299) ); emergency status expired effective July 6, 2022</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective July 1, 2010 (37:10 Md. R. 722)</annotation> </annotations> </chapter> <chapter num="16" heading="Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Committee” means, in this chapter, a joint committee of representatives from the Board of Pharmacy and the Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Portable drug kit” means a container comprising prescription drugs and other emergency medical supplies or drugs for use in licensed home health and licensed hospice settings, and by home infusion providers licensed as residential services agencies.</text> </paragraph> <paragraph num="(3)"> <text>“Prescription protocol” means an order for a portable drug kit signed by the medical director of a licensed home health agency, licensed general hospice, or a home infusion provider licensed as a residential services agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Prescription Protocol."> <text>Before distributing a portable drug kit, the pharmacist shall ensure that the prescription protocol includes:</text> <paragraph num="A."> <text>The name, strength, and quantity of a drug to be included in the portable drug kit;</text> </paragraph> <paragraph num="B."> <text>The name of the receiving agency or designated agent;</text> </paragraph> <paragraph num="C."> <text>The directions for use;</text> </paragraph> <paragraph num="D."> <text>Conditions for use;</text> </paragraph> <paragraph num="E."> <text>Contraindications for use; and</text> </paragraph> <paragraph num="F."> <text>The signature, printed name, and telephone number of the physician authorizing the kit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Records."> <text>A pharmacist shall:</text> <paragraph num="A."> <text>File the prescription protocol in a readily retrievable manner;</text> </paragraph> <paragraph num="B."> <text>Document the:</text> <paragraph num="(1)"> <text>Date of distribution of the portable drug kit,</text> </paragraph> <paragraph num="(2)"> <text>Name of the person or agency to whom the kit is delivered, and</text> </paragraph> <paragraph num="(3)"> <text>Date of delivery for each kit distributed;</text> </paragraph> </paragraph> <paragraph num="C."> <text>File an administration record for all drugs administered from a kit upon return of the kit to the pharmacy; and</text> </paragraph> <paragraph num="D."> <text>Notify the Board of Pharmacy before distributing portable drug kits under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements of the Portable Drug Kit."> <paragraph num="A."> <text>The pharmacist shall ensure that the portable drug kit:</text> <paragraph num="(1)"> <text>Is sealed with a tamper evident tag or other means for detecting entry to the kit;</text> </paragraph> <paragraph num="(2)"> <text>Displays on the outside of the kit:</text> <paragraph num="(a)"> <text>A serial number unique to the kit;</text> </paragraph> <paragraph num="(b)"> <text>An expiration date which reflects the earliest expiration date of any item contained in the kit;</text> </paragraph> <paragraph num="(c)"> <text>The contents of the kit;</text> </paragraph> <paragraph num="(d)"> <text>That the contents are or are not sterile;</text> </paragraph> <paragraph num="(e)"> <text>The legend “To be returned to the pharmacy within 5 days of breaking seal, with a completed administration record or prescription enclosed”; and</text> </paragraph> <paragraph num="(f)"> <text>Storage requirements for the contents;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Contains:</text> <paragraph num="(a)"> <text>Only prescription drugs and nonprescription items approved for the kit by a committee as defined in Regulation .01B(1) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>A temperature monitor to indicate maintenance of proper storage conditions; and</text> </paragraph> <paragraph num="(c)"> <text>A written administration record to be completed by the licensed health care provider using the kit, which includes the administration record indicating:</text> <paragraph num="(i)"> <text>The name of the patient,</text> </paragraph> <paragraph num="(ii)"> <text>The name of the prescriber,</text> </paragraph> <paragraph num="(iii)"> <text>Drug name, form, and dosage,</text> </paragraph> <paragraph num="(iv)"> <text>Date the drug was used or wasted,</text> </paragraph> <paragraph num="(v)"> <text>The reason for administration or wastage of the drug, and</text> </paragraph> <paragraph num="(vi)"> <text>The name of the licensed health care provider utilizing the kit;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Displays or includes written information inside the kit listing contraindications to use of the kit; and</text> </paragraph> <paragraph num="(5)"> <text>Does not contain a controlled dangerous substance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacist shall only distribute a portable drug kit which complies with the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Contents of Portable Drug Kit."> <text>The committee shall review annually the approved prescription drugs and nonprescription items to ensure that the contents of a portable drug kit are appropriate.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Distribution of Portable Drug Kits."> <text>Portable drug kits may only be distributed to licensed health care providers who are authorized by law to administer the contents of a portable drug kit.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 6, 1999 (26:18 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05 and.06 adopted effective April 16, 2001 (28:7 Md. R. 690)</annotation> </annotations> </chapter> <chapter num="17" heading="Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service and nursing service rendered by or under the supervision of a registered nurse.</text> </paragraph> <paragraph num="(3)"> <text>“Continuing care in a retirement community” means providing shelter and providing either medical and nursing or other health related services or making the services readily accessible through the provider or an affiliate of the provider, whether or not the services are specifically offered in the written agreement for shelter:</text> <paragraph num="(a)"> <text>To an individual who is 60 years old or older and not related by blood or marriage to the provider;</text> </paragraph> <paragraph num="(b)"> <text>For the life of the individual or for a period exceeding 1 year; and</text> </paragraph> <paragraph num="(c)"> <text>Under one or more written agreements that require a transfer of assets or an entrance fee notwithstanding periodic charges.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Full service pharmacy” means a pharmacy that provides complete pharmaceutical services to the general public and does not restrict or limit its services to any group of individuals.</text> </paragraph> <paragraph num="(5)"> <text>Pharmaceutical Specialty.</text> <paragraph num="(a)"> <text>“Pharmaceutical specialty” means a limited pharmaceutical service provided by a pharmacy that:</text> <paragraph num="(i)"> <text>Is in or makes use of a specialized setting by virtue of certain equipment, systems, location, or physical structure; and</text> </paragraph> <paragraph num="(ii)"> <text>Restricts or limits its services to a group or groups of individuals requiring such specialty services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Pharmaceutical specialty” includes the following services:</text> <paragraph num="(i)"> <text>Assisted living facilities;</text> </paragraph> <paragraph num="(ii)"> <text>Comprehensive care facilities;</text> </paragraph> <paragraph num="(iii)"> <text>Developmental disabilities facilities;</text> </paragraph> <paragraph num="(iv)"> <text>Home infusion;</text> </paragraph> <paragraph num="(v)"> <text>Inpatient hospital;</text> </paragraph> <paragraph num="(vi)"> <text>Nonsterile compounding;</text> </paragraph> <paragraph num="(vii)"> <text>Nuclear pharmaceutical;</text> </paragraph> <paragraph num="(viii)"> <text>Research;</text> </paragraph> <paragraph num="(ix)"> <text>Sterile compounding;</text> </paragraph> <paragraph num="(x)"> <text>Veterinary care;</text> </paragraph> <paragraph num="(xi)"> <text>Provision of pharmaceutical services across all settings of care within a continuing care in a retirement community; and</text> </paragraph> <paragraph num="(xii)"> <text>Other services approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Waiver pharmacy” means a pharmacy that has been issued a waiver permit by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Pharmaceutical Specialty."> <paragraph num="A."> <text>The Board may recognize as a pharmaceutical specialty not listed under Regulation .01B(4) of this chapter, upon written application and supporting documentation to the Board by an applicant for a waiver permit.</text> </paragraph> <paragraph num="B."> <text>When evaluating an application for a waiver pharmacy, the Board shall consider whether:</text> <paragraph num="(1)"> <text>The pharmaceutical specialty service is necessary to meet a specific therapeutic need;</text> </paragraph> <paragraph num="(2)"> <text>The location is accessible without endangering public health and safety;</text> </paragraph> <paragraph num="(3)"> <text>The pharmacy is properly equipped to perform the pharmaceutical specialty;</text> </paragraph> <paragraph num="(4)"> <text>The applicant has provided a full and detailed description of the pharmaceutical specialty that clearly substantiates the basis for the request of a waiver permit; and</text> </paragraph> <paragraph num="(5)"> <text>A policy and procedure manual is included with the application which sets forth a detailed description of the pharmacy operation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>No one criterion or combination of criteria listed in §B of this regulation shall be binding upon the Board.</text> </paragraph> <paragraph num="D."> <text>The Board's determination of whether a limited practice or setting constitutes a pharmaceutical specialty is final.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements of a Waiver Pharmacy."> <paragraph num="A."> <text>The Board shall issue a waiver permit to an applicant that:</text> <paragraph num="(1)"> <text>Meets the requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Performs pharmaceutical specialty services:</text> <paragraph num="(a)"> <text>Listed in Regulation .01B(4) of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Submit an application form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay a fee as set forth in COMAR 10.34.09;</text> </paragraph> <paragraph num="(3)"> <text>Submit any other documentation as required by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Employ at least one pharmacist at the applicant's proposed facility who has received education or training in the pharmaceutical specialty in addition to that required for licensure; and</text> </paragraph> <paragraph num="(5)"> <text>Notify the Board in writing within 30 days of any change in the information given on the initial or renewal waiver pharmacy application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Restricted Practice."> <paragraph num="A."> <text>A waiver pharmacy is restricted to the pharmaceutical specialty services approved by the Board in the waiver permit.</text> </paragraph> <paragraph num="B."> <text>A waiver pharmacy may not perform functions of a full service pharmacy.</text> </paragraph> <paragraph num="C."> <text>A full service pharmacy may perform pharmaceutical specialty services as long as the full service pharmacy is able to demonstrate competency in performing the pharmaceutical specialty.</text> </paragraph> <paragraph num="D."> <text>A full service pharmacy and a waiver pharmacy may operate on the same premises provided that the full service pharmacy and the waiver pharmacy:</text> <paragraph num="(1)"> <text>Obtain separate permits from the Board;</text> </paragraph> <paragraph num="(2)"> <text>Are supervised by separate licensed pharmacists who are responsible for the operations of their respective pharmacies at all times the pharmacies are in operation; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain separate inventory and record keeping for each pharmacy permit.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-403, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 15, 1987 (14:12 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 17, 1994 (20:1 Md. R. 34)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 19, 2009 (36:21 Md. R. 1591)</annotation> </annotations> </chapter> <chapter num="18" heading="Continuing Education for Pharmacists"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern any person who desires to renew a license to practice pharmacy in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Live Instruction.</text> <paragraph num="(1)"> <text>“Live instruction” means a course offering the ability for the participant to have real-time interaction with the presenter.</text> </paragraph> <paragraph num="(2)"> <text>“Live instruction” includes programs approved by the American Council on Pharmaceutical Education (ACPE) that are designated by the letter “L” in the course identification number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Exceptions."> <paragraph num="A."> <text>This chapter does not apply to pharmacists applying for renewal for the first renewal period following the issuance of the original license, if the pharmacist obtains a license within 1 year of the completion of the pharmacist's pharmaceutical education.</text> </paragraph> <paragraph num="B."> <text>The Board may grant an exception from the continuing education requirements if the pharmacist presents evidence that failure to comply was due to circumstances beyond the pharmacist's control.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Pharmacists Practicing in Maryland."> <paragraph num="A."> <text>A pharmacist license expires on the last day of the pharmacist's birth month every other year.</text> </paragraph> <paragraph num="B."> <text>Before the expiration date of the pharmacist's license, the pharmacist shall:</text> <paragraph num="(1)"> <text>File a renewal application;</text> </paragraph> <paragraph num="(2)"> <text>Pay any applicable fees; and</text> </paragraph> <paragraph num="(3)"> <text>Earn continuing pharmaceutical education (CE) credits required by this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>CE Requirements.</text> <paragraph num="(1)"> <text>A pharmacist licensed to practice in Maryland applying for renewal shall:</text> <paragraph num="(a)"> <text>Earn 30 hours of approved CE within the 2-year period immediately preceding the license expiration date that include:</text> <paragraph num="(i)"> <text>1 hour on the topic of preventing medication errors, such as appropriate dispensing of opioids; and</text> </paragraph> <paragraph num="(ii)"> <text>2 hours of CE obtained through live instruction;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Attest to the fact that the pharmacist has completed the CE requirement on a Board approved form; and</text> </paragraph> <paragraph num="(c)"> <text>Retain supporting documents for inspection by the Board for 4 years after the date of renewal for which the CE credits were used.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pharmacist certified to administer vaccinations in Maryland applying for renewal shall:</text> <paragraph num="(a)"> <text>As part of the 30 hours of approved CE requirement, complete 4 hours of CE credits related to vaccinations; or</text> </paragraph> <paragraph num="(b)"> <text>If registered to administer vaccines before October 1, 2008 for the first renewal of the registration after that date, demonstrate that 4 CE credits taken include education about the herpes zoster and pneumococcal pneumonia vaccines.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Pharmacists Not Practicing in Maryland."> <text>A licensed pharmacist not practicing in Maryland shall fulfill the continuing education requirements of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for Pharmacists who are Authorized Prescribers."> <text>A pharmacist who is also an authorized prescriber licensed by a board (in Maryland or another state) may use the continuing education (CE) credits applied toward that board toward the Board of Pharmacy's CE requirements.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Accredited Continuing Education Programs."> <paragraph num="A."> <text>The Board and the following providers are approved for any programs they offer which otherwise qualify for continuing education (CE) credit:</text> <paragraph num="(1)"> <text>American Council on Pharmaceutical Education (ACPE);</text> </paragraph> <paragraph num="(2)"> <text>Schools of pharmacy accredited by ACPE;</text> </paragraph> <paragraph num="(3)"> <text>Food and Drug Administration (FDA);</text> </paragraph> <paragraph num="(4)"> <text>Drug Enforcement Administration (DEA); and</text> </paragraph> <paragraph num="(5)"> <text>Additional providers of programs approved by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Procedures for Approval of Additional Programs.</text> <paragraph num="(1)"> <text>An additional provider shall request approval for an individual program by submitting a Board application at least 60 days before the date of offering of their individual program.</text> </paragraph> <paragraph num="(2)"> <text>An approval request shall fulfill the program requirements set forth in Health Occupations Article, §12-309(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>An approval request shall include a description of course work including:</text> <paragraph num="(a)"> <text>Measurable learning objectives;</text> </paragraph> <paragraph num="(b)"> <text>A course outline; and</text> </paragraph> <paragraph num="(c)"> <text>Self-assessment questions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board's decision to approve or disapprove a program is final.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Record Keeping for Providers of Approved Programs.</text> <paragraph num="(1)"> <text>Providers of approved programs shall maintain program records for 3 years from the date of presentation of the program.</text> </paragraph> <paragraph num="(2)"> <text>Providers of approved programs of CE shall furnish a certificate of completion to participants who qualify. The provider shall include the:</text> <paragraph num="(a)"> <text>Name of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Name of the provider;</text> </paragraph> <paragraph num="(c)"> <text>Title of the course;</text> </paragraph> <paragraph num="(d)"> <text>Number of CE hours;</text> </paragraph> <paragraph num="(e)"> <text>Date of completion; and</text> </paragraph> <paragraph num="(f)"> <text>A program identification number or provider number on the certificate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may rescind approval of a CE program if it determines that the program no longer meets the requirements of Health Occupations Article, §12-309, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Acceptance of Previously Unapproved Continuing Education Programs."> <paragraph num="A."> <text>A pharmacist who completes a program of continuing education that is not previously approved by the Board may request in writing that the Board approve the program for credit.</text> </paragraph> <paragraph num="B."> <text>The pharmacist making a request for Board approval under §A of this regulation shall make the request at least 90 days before licensed expiration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Miscellaneous."> <paragraph num="A."> <text>Credits may not be carried over from one licensing renewal period to another.</text> </paragraph> <paragraph num="B."> <text>Falsifying continuing education CE records is grounds for disciplinary action.</text> </paragraph> <paragraph num="C."> <text>The pharmacist shall use a Board approved form to supply the pharmacist's CE information to the Board.</text> </paragraph> <paragraph num="D."> <text>CE requirements imposed by the Board upon a pharmacist as part of an informal action, consent order, or final order, as defined in COMAR 10.34.01.02, shall be in addition to the requirements of this chapter.</text> </paragraph> <paragraph num="E."> <text>Pharmacists may receive 2 CE credits for attending a public Board meeting in its entirety.</text> <paragraph num="(1)"> <text>The Board shall issue a certificate of proof of attendance at a public Board meeting.</text> </paragraph> <paragraph num="(2)"> <text>A pharmacist may not earn more than 4 CE credits per renewal period for attendance of a public Board meeting.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 8, 1988 (15:16 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 3, 1995 (22:13 Md. R. 967)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective November 3, 1997 (24:22 Md. R. 1552)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective April 30, 2012 (39:8 Md. R. 536)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective June 5, 2017 (44:11 Md. R. 525)</annotation> </annotations> </chapter> <chapter num="19" heading="Sterile Pharmaceutical Compounding"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to a licensed pharmacy in Maryland engaging in:</text> <paragraph num="A."> <text>Compounding or mixing sterile prescription solutions or suspensions to be administered parenterally or by irrigation, inhalation, or intraocular routes; and</text> </paragraph> <paragraph num="B."> <text>Compounding of radiopharmaceuticals, except where U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations addresses radiopharmaceuticals, U.S. Pharmacopeia (USP) Chapter 821 Radioactivity, and U.S. Pharmacopeia (USP) Chapter 823 Radiopharmaceuticals for Positron Emission Tomography — Compounding would apply.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations (USP 797 Standards), which has been incorporated by reference in 21 U.S.C. §351(b) (as amended).</text> </paragraph> <paragraph num="B."> <text>U.S. Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding — Non-Sterile Preparations (USP 795 Standards), which has been incorporated by reference in 21 U.S.C. §351(b) (as amended).</text> </paragraph> <paragraph num="C."> <text>U.S. Pharmacopeia (USP) Chapter 821 Radioactivity, which has been incorporated by reference in 21 U.S.C. §351(b) (as amended).</text> </paragraph> <paragraph num="D."> <text>U.S. Pharmacopeia (USP) Chapter 823 Radiopharmaceuticals for Positron Emission Tomography — Compounding, which has been incorporated by reference in 21 U.S.C. §351(b) (as amended).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adverse event” means:</text> <paragraph num="(a)"> <text>Any adverse patient outcome related to the sterile compounding process; or</text> </paragraph> <paragraph num="(b)"> <text>Evidence of environmental contamination, including microbial contamination above the threshold set forth in USP 797 Standards.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Antineoplastic” means an agent that prevents the development, growth, or proliferation of malignant cells.</text> </paragraph> <paragraph num="(3)"> <text>“Anteroom” means the area, room, or rooms where personnel perform hand hygiene and garbing immediately adjacent to the designated clean room where the compounding of sterile preparations is performed.</text> </paragraph> <paragraph num="(4)"> <text>Batch.</text> <paragraph num="(a)"> <text>“Batch” means a preparation compounded in advance of receipt of a prescription, or a preparation compounded in a supply that will be used on more than one dispensing to a patient or patients or any preparation compounded in excess of the filling of an individual prescription.</text> </paragraph> <paragraph num="(b)"> <text>“Batch” includes a limited quantity of identical preparations compounded in a single, discrete process, by the same individuals, carried out during one limited time period.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Biological safety cabinet” means a containment unit:</text> <paragraph num="(a)"> <text>Suitable for work involving agents that pose higher risk of exposure to operators during compounding; and</text> </paragraph> <paragraph num="(b)"> <text>Used when there is a need for protection of the preparation, personnel, and environment.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Clean room” means a room with an International Standards Organization (ISO) Class 5 environment or an ISO Class 7 environment that meets USP 797 Standards, inside which compounding occurs within an ISO Class 5 engineering control device such as a laminar airflow workstation or a biological safety cabinet.</text> </paragraph> <paragraph num="(7)"> <text>“Closed system vial transfer device (CSTD)” means a closed system drug transfer device that mechanically, not by means of vents or filters, prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug aerosols or vapors into the environment.</text> </paragraph> <paragraph num="(8)"> <text>“Compounded sterile preparation” means sterile medication preparations, such as intravenous, epidural, and intraocular medications, compounded in the pharmacy using currently accepted aseptic compounding techniques under acceptable compounding conditions.</text> </paragraph> <paragraph num="(9)"> <text>“Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug:</text> <paragraph num="(a)"> <text>As the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient relationship in the course of professional practice;</text> </paragraph> <paragraph num="(b)"> <text>For the purpose of, or incidental to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device; or</text> </paragraph> <paragraph num="(c)"> <text>In anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Compounding aseptic isolator” means an enclosed positive or negative pressure environment especially designed for sterile preparation compounding that maintains a physical barrier between the workspace and the operator.</text> </paragraph> <paragraph num="(11)"> <text>“Controlled environment” means a designated area for compounding sterile preparations that consists of a clean room and an anteroom.</text> </paragraph> <paragraph num="(12)"> <text>“Cytotoxic” means drug entities that are damaging or debilitating to cells, tissues, or organs.</text> </paragraph> <paragraph num="(13)"> <text>“Designee” means a public agency or private entity trained in:</text> <paragraph num="(a)"> <text>USP 797 Standards;</text> </paragraph> <paragraph num="(b)"> <text>FDA good manufacturing practices approved by the Board to conduct inspections of nonresident pharmacies that perform sterile compounding; or</text> </paragraph> <paragraph num="(c)"> <text>Both §B(13)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Laminar air flow workstation” means an ISO Class 5 (“Class 100”) laminar airflow hood inside which sterile compounding occurs.</text> </paragraph> <paragraph num="(15)"> <text>“Media fill verification” means a process of practical examination to verify the aseptic technique of personnel or an aseptic process by manual manipulation of microbiological growth media which simulates compounding processes and techniques used in actual compounding procedures.</text> </paragraph> <paragraph num="(16)"> <text>“Parenteral” means routes of drug administration or fluid administration other than via the gastrointestinal tract.</text> </paragraph> <paragraph num="(17)"> <text>“Pharmacist” means an individual who is licensed to practice pharmacy regardless of the location where the activities of practice are performed.</text> </paragraph> <paragraph num="(18)"> <text>“Pharmacy” means an establishment in which prescription or nonprescription drugs or devices are compounded, dispensed, or distributed.</text> </paragraph> <paragraph num="(19)"> <text>“Pyrogen testing” means an analysis of sterile preparations for the presence of cell material from microbiological organisms in sufficient quantity to elicit a febrile reaction.</text> </paragraph> <paragraph num="(20)"> <text>“Risk level” means a risk level of low, medium, or high as defined in USP 797 Standards.</text> </paragraph> <paragraph num="(21)"> <text>“Sterile” means free from living microorganisms or any other contaminants.</text> </paragraph> <paragraph num="(22)"> <text>“Sterile compounding” means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques.</text> </paragraph> <paragraph num="(23)"> <text>“Total parenteral nutrition” means providing caloric needs by the parenteral route for a patient who is unable to ingest sufficient calories.</text> </paragraph> <paragraph num="(24)"> <text>“USP 795 Standards” means standards set forth in the US Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding — Non-Sterile Preparations.</text> </paragraph> <paragraph num="(25)"> <text>“USP 797 Standards” means standards set forth in the U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Pharmacy Environment."> <text>The compounding, preparation, and dispensing of compounded sterile preparations shall be accomplished in a pharmacy environment subject to State and federal laws, regulations, and standards.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="General Requirements."> <text>A licensed pharmacist who has appropriate practical and didactic training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy shall control and supervise the section of the pharmacy that prepares compounded sterile preparations and is responsible for, at a minimum, the following:</text> <paragraph num="A."> <text>Preparation of compounded sterile preparations within the pharmacy or decentralized pharmacy;</text> </paragraph> <paragraph num="B."> <text>Storage of materials pertinent to the preparation of compounded sterile preparations, including drugs, chemicals, and biologicals, and the establishment of specifications for procurement of the materials;</text> </paragraph> <paragraph num="C."> <text>Labeling of containers of compounded sterile preparations compounded within the pharmacy;</text> </paragraph> <paragraph num="D."> <text>Recording of transactions of the pharmacy as may be applicable to State and federal laws and regulations, as may be necessary to maintain accurate control over, and accountability for, pharmaceutical materials; and</text> </paragraph> <paragraph num="E."> <text>Ensuring that licensed pharmacists meeting the requirements of §A of this regulation, or registered pharmacy technicians under direct supervision of a licensed pharmacist meeting the requirements of §A of this regulation, prepare, compound, and dispense compounded sterile preparations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Special Handling, Packaging, Labeling, and Beyond Use Dating."> <paragraph num="A."> <text>The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including:</text> <paragraph num="(1)"> <text>A reasonable effort to provide tamper-evident packaging if appropriate to setting;</text> </paragraph> <paragraph num="(2)"> <text>Proper in-transit storage consistent with preparation labeling; and</text> </paragraph> <paragraph num="(3)"> <text>Delivery to the patient within a reasonable time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:</text> <paragraph num="(1)"> <text>The date of preparation unless otherwise readily retrievable from prescription records;</text> </paragraph> <paragraph num="(2)"> <text>Time prepared, if applicable;</text> </paragraph> <paragraph num="(3)"> <text>The pertinent requirements for proper storage;</text> </paragraph> <paragraph num="(4)"> <text>The name of the prescriber, unless in an inpatient hospital setting;</text> </paragraph> <paragraph num="(5)"> <text>The name of the patient;</text> </paragraph> <paragraph num="(6)"> <text>Directions for use;</text> </paragraph> <paragraph num="(7)"> <text>The name of the base solution for infusion preparations;</text> </paragraph> <paragraph num="(8)"> <text>The name and concentration or amount of active drugs contained in the final sterile preparation;</text> </paragraph> <paragraph num="(9)"> <text>The name or identifying initials of the pharmacist who checked or prepared the compounded sterile preparation unless otherwise readily retrievable from prescription records;</text> </paragraph> <paragraph num="(10)"> <text>The name, address, and telephone number of the pharmacy unless in an inpatient hospital facility;</text> </paragraph> <paragraph num="(11)"> <text>The beyond-use/expiration dating and time of the compounded sterile preparation, and if no time is stated, the time is presumed to be at 11:59 p.m. of the stated beyond use date;</text> </paragraph> <paragraph num="(12)"> <text>Any ancillary and cautionary instructions as needed; and</text> </paragraph> <paragraph num="(13)"> <text>A pertinent warning consistent with applicable federal and State law that cytotoxic preparations are biohazardous, when applicable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.</text> </paragraph> <paragraph num="D."> <text>Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP 795 Standards, the pharmacist shall use “beyond-use dating” as determined by USP 797 Standards and reference materials as cited in Regulation .16 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Record-Keeping Requirements."> <paragraph num="A."> <text>Patient Prescription Records.</text> <paragraph num="(1)"> <text>The pharmacy shall maintain records of patient prescriptions.</text> </paragraph> <paragraph num="(2)"> <text>Patient prescription records shall contain:</text> <paragraph num="(a)"> <text>Available medical information consistent with prevailing pharmacy standards; and</text> </paragraph> <paragraph num="(b)"> <text>The complete record of the formulations of the solutions that were compounded.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The pharmacy shall keep completed patient prescription records in a retrievable manner for at least 5 years, either:</text> <paragraph num="(a)"> <text>At the inspection site; or</text> </paragraph> <paragraph num="(b)"> <text>So as to be immediately retrievable by computer or other electronic means.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Compounded Sterile Preparations Records.</text> <paragraph num="(1)"> <text>For a pharmacy preparing compounded sterile preparations, the following records shall be maintained for at least 5 years:</text> <paragraph num="(a)"> <text>The training and competency evaluation of employees in sterile preparation procedures;</text> </paragraph> <paragraph num="(b)"> <text>Refrigerator and freezer temperatures;</text> </paragraph> <paragraph num="(c)"> <text>Certification of the sterile compounding environment, including ISO 5 workstations and the clean and anterooms;</text> </paragraph> <paragraph num="(d)"> <text>Other facility quality control logs specific to the pharmacy's policies and procedures, for example, cleaning logs for facilities and equipment;</text> </paragraph> <paragraph num="(e)"> <text>Records documenting inspection for expired or recalled pharmaceutical preparations or raw ingredients;</text> </paragraph> <paragraph num="(f)"> <text>Preparation records including compounding work sheets, and records of the registered pharmacy technicians' checking/sign-off process; and</text> </paragraph> <paragraph num="(g)"> <text>Preparation records including compounding work sheets and records of the pharmacists' checking/sign-off process.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a pharmacy compounding sterile batch preparations for future use shall have records indicating the:</text> <paragraph num="(a)"> <text>Drug and ingredient names;</text> </paragraph> <paragraph num="(b)"> <text>Lot numbers;</text> </paragraph> <paragraph num="(c)"> <text>Expiration dates;</text> </paragraph> <paragraph num="(d)"> <text>Drug/diluent amounts; and</text> </paragraph> <paragraph num="(e)"> <text>Date on which the compounded sterile batch preparations were prepared.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A pharmacy shall maintain records of media fill verification results for 5 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Batch Preparation."> <paragraph num="A."> <text>A pharmacist may prepare batched sterile preparations for future use in limited quantities supported by prior valid prescriptions or physician orders before receiving a valid written prescription or medication order.</text> </paragraph> <paragraph num="B."> <text>Batch preparation of specific compounded sterile preparations is acceptable if the:</text> <paragraph num="(1)"> <text>Pharmacist can document a history of valid prescriptions or physician orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship; and</text> </paragraph> <paragraph num="(2)"> <text>Pharmacy maintains the prescription on file for such preparations dispensed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Minimum Facility Requirements."> <paragraph num="A."> <text>Controlled Environment.</text> <paragraph num="(1)"> <text>The pharmacy shall have a controlled environment that meets USP 797 Standards.</text> </paragraph> <paragraph num="(2)"> <text>A pharmacist shall ensure that the controlled environment is:</text> <paragraph num="(a)"> <text>Accessible only to designated personnel; and</text> </paragraph> <paragraph num="(b)"> <text>Used only for the preparation of compounded sterile preparations, or such other tasks that require a controlled environment.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The permit holder shall ensure that the controlled environment is:</text> <paragraph num="(a)"> <text>Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and</text> </paragraph> <paragraph num="(b)"> <text>Air conditioned to maintain a temperature of the controlled environment according to USP 797 standards.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Controlled Environment — Clean Room. The permit holder shall ensure that the clean room in the controlled environment:</text> <paragraph num="(1)"> <text>Meets USP 797 Standards for design and USP 797 performance criteria quality standards for clean rooms;</text> </paragraph> <paragraph num="(2)"> <text>Contains no sinks or floor drains;</text> </paragraph> <paragraph num="(3)"> <text>Contains work surfaces constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized;</text> </paragraph> <paragraph num="(4)"> <text>If cytotoxic agents are routinely used in compounding preparations, contains room or rooms equipped with special pressurization requirements consistent with USP 797 Standards and the National Institute for Occupational Safety and Health (NIOSH) standards;</text> </paragraph> <paragraph num="(5)"> <text>Has in place appropriate environmental engineering control devices capable of maintaining USP 797 air-quality standards during normal compounding activity; and</text> </paragraph> <paragraph num="(6)"> <text>Contains the following equipment:</text> <paragraph num="(a)"> <text>A laminar airflow workstation or other suitable International Standards Organization (ISO) Class 5 compounding environment;</text> </paragraph> <paragraph num="(b)"> <text>Waste containers that are approved by Occupational Safety and Health Administration (OSHA) for used needles and syringes, and for chemotherapy waste; and</text> </paragraph> <paragraph num="(c)"> <text>Ancillary supplies required for proper compounding.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Controlled Environment — Anteroom. The permit holder shall ensure that the anteroom in the controlled environment:</text> <paragraph num="(1)"> <text>Meets USP 797 Standards for design and USP 797 performance criteria quality standards for anterooms; and</text> </paragraph> <paragraph num="(2)"> <text>Contains the following equipment:</text> <paragraph num="(a)"> <text>A sink with hot and cold running water;</text> </paragraph> <paragraph num="(b)"> <text>Waste containers for personal protective equipment;</text> </paragraph> <paragraph num="(c)"> <text>An eyewash station or sink design suitable for flushing an eye injury; and</text> </paragraph> <paragraph num="(d)"> <text>A hazardous waste spill kit, if applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The requirements specified in §§B(1) and C(1) of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with the:</text> <paragraph num="(1)"> <text>Compounding aseptic isolator conditions set forth in USP 797 Standards; and</text> </paragraph> <paragraph num="(2)"> <text>Isolator vendor or manufacturer specifications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Minimum Requirements for Equipment."> <paragraph num="A."> <text>The permit holder shall provide at least the following equipment that is maintained in working order:</text> <paragraph num="(1)"> <text>Adequate refrigerator and freezer space (if applicable);</text> </paragraph> <paragraph num="(2)"> <text>A sink and wash area in the anteroom;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate waste containers for:</text> <paragraph num="(a)"> <text>Used needles and syringes; and</text> </paragraph> <paragraph num="(b)"> <text>Cytotoxic waste including disposable apparel used in its preparation, if applicable;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Laminar air flow workstation or compounding aseptic isolator that meets USP 797 Standards, dedicated for products other than antineoplastics;</text> </paragraph> <paragraph num="(5)"> <text>If applicable to types of preparations compounded, biological safety cabinet, or compounding aseptic isolator that meets USP 797 Standards, dedicated for use with antineoplastics or other hazardous sterile preparations;</text> </paragraph> <paragraph num="(6)"> <text>Appropriate filters and filtration equipment; and</text> </paragraph> <paragraph num="(7)"> <text>A device for light/dark field examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If used, the permit holder shall provide the following equipment that is maintained in working order, calibrated, or certified where appropriate:</text> <paragraph num="(1)"> <text>Autoclave;</text> </paragraph> <paragraph num="(2)"> <text>Automated compounding devices (for example, total parenteral nutrition compounding pumps);</text> </paragraph> <paragraph num="(3)"> <text>Electronic balance;</text> </paragraph> <paragraph num="(4)"> <text>Convection oven;</text> </paragraph> <paragraph num="(5)"> <text>Thermometers or other temperature device; and</text> </paragraph> <paragraph num="(6)"> <text>Incubator.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Minimum Requirements for Supplies."> <text>A pharmacy engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to:</text> <paragraph num="A."> <text>Personal protective equipment:</text> <paragraph num="(1)"> <text>Sterile gloves;</text> </paragraph> <paragraph num="(2)"> <text>Masks;</text> </paragraph> <paragraph num="(3)"> <text>Non-shedding gowns;</text> </paragraph> <paragraph num="(4)"> <text>Shoe covers;</text> </paragraph> <paragraph num="(5)"> <text>Hair covers;</text> </paragraph> <paragraph num="(6)"> <text>Beard covers; and</text> </paragraph> <paragraph num="(7)"> <text>Other personal protective equipment;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Disposable syringes and needles in necessary sizes;</text> </paragraph> <paragraph num="C."> <text>Disinfectant cleaning agents as specified in USP 797 Standards, including 70 percent sterile isopropyl alcohol;</text> </paragraph> <paragraph num="D."> <text>Disposable lint free towels;</text> </paragraph> <paragraph num="E."> <text>Hand washing materials, including antimicrobial skin cleanser;</text> </paragraph> <paragraph num="F."> <text>Adequate equipment and materials for antineoplastic or cytotoxic agent spills;</text> </paragraph> <paragraph num="G."> <text>Supplies necessary for the aseptic preparation of compounded sterile preparations; and</text> </paragraph> <paragraph num="H."> <text>Closed system vial transfer devices (CSTD), as required for cytotoxic compounding, if applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Minimum Requirements for Policies and Procedures."> <paragraph num="A."> <text>The permit holder shall ensure that the pharmacist or the pharmacist's designee shall maintain a policy and procedure manual, reviewed annually, that sets forth in detail the permit holder's standard operating procedures with regard to compounding sterile preparations.</text> </paragraph> <paragraph num="B."> <text>The permit holder shall insure that the policy and procedure manual that sets forth the standard operating procedures with regard to compounding sterile preparations is implemented and adhered to.</text> </paragraph> <paragraph num="C."> <text>The policy and procedure manual shall include policies and procedures governing the following:</text> <paragraph num="(1)"> <text>A risk-management program which includes documentation of outcomes including, but not limited to:</text> <paragraph num="(a)"> <text>An incident reporting system;</text> </paragraph> <paragraph num="(b)"> <text>An adverse drug reaction reporting system; and</text> </paragraph> <paragraph num="(c)"> <text>A preparation contamination reporting system;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Security measures ensuring that the premises where sterile compounded preparations are stored and prepared are secured, to prevent access by unauthorized personnel;</text> </paragraph> <paragraph num="(3)"> <text>Equipment including, but not limited to:</text> <paragraph num="(a)"> <text>Procedures for use;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of appropriate certifications; and</text> </paragraph> <paragraph num="(c)"> <text>Documentation of appropriate calibration and preventive maintenance if applicable;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Sanitation standards and procedures including monitoring for bacterial microorganisms to demonstrate effectiveness of cleaning activities;</text> </paragraph> <paragraph num="(5)"> <text>Reference materials as set forth in Regulation .16 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Information concerning drug:</text> <paragraph num="(a)"> <text>Preparation;</text> </paragraph> <paragraph num="(b)"> <text>Storage and handling;</text> </paragraph> <paragraph num="(c)"> <text>Dispensing;</text> </paragraph> <paragraph num="(d)"> <text>Labeling;</text> </paragraph> <paragraph num="(e)"> <text>Beyond-use/expiration dating;</text> </paragraph> <paragraph num="(f)"> <text>Delivery;</text> </paragraph> <paragraph num="(g)"> <text>Destruction;</text> </paragraph> <paragraph num="(h)"> <text>Recalls; and</text> </paragraph> <paragraph num="(i)"> <text>Returns;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Patient record keeping as set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Handling, dispensing, and documentation of investigational drugs;</text> </paragraph> <paragraph num="(9)"> <text>A quality assurance program;</text> </paragraph> <paragraph num="(10)"> <text>Verification of training and competency guidelines;</text> </paragraph> <paragraph num="(11)"> <text>Compounding process media fill verification procedures;</text> </paragraph> <paragraph num="(12)"> <text>Description of appropriate garb;</text> </paragraph> <paragraph num="(13)"> <text>Conduct guidelines for personnel in the controlled areas;</text> </paragraph> <paragraph num="(14)"> <text>Personnel responsibilities;</text> </paragraph> <paragraph num="(15)"> <text>Patient education, if appropriate;</text> </paragraph> <paragraph num="(16)"> <text>Protocol and procedures to maintain the integrity of the interior work area of the laminar air flow workstations;</text> </paragraph> <paragraph num="(17)"> <text>Written procedures as applicable for handling antineoplastic agents and other hazardous substances including:</text> <paragraph num="(a)"> <text>Utilizing the proper equipment and supplies;</text> </paragraph> <paragraph num="(b)"> <text>A statement that compounding shall be conducted within a properly certified biological safety cabinet or negative pressure compounding aseptic isolator;</text> </paragraph> <paragraph num="(c)"> <text>Proper use of protective attire; and</text> </paragraph> <paragraph num="(d)"> <text>Proper techniques to prevent both contamination of the preparation and chemical exposure of the individual preparing the prescription;</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Written procedures as applicable for the disposal of infectious materials or materials containing cytotoxic residues, or hazardous waste;</text> </paragraph> <paragraph num="(19)"> <text>Written documentation of policy and procedure changes based on data gathered from quality assurance evaluations; and</text> </paragraph> <paragraph num="(20)"> <text>Written documentation of policies and procedures assuring the sterility and stability of compounded sterile preparations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Attire."> <paragraph num="A."> <text>When compounding sterile preparations, individuals shall comply with the following standards:</text> <paragraph num="(1)"> <text>Sequencing of garbing that complies with USP 797 Standards;</text> </paragraph> <paragraph num="(2)"> <text>Thorough hand-washing before gowning;</text> </paragraph> <paragraph num="(3)"> <text>Wearing clean room garb inside the designated area at all times, which consists of:</text> <paragraph num="(a)"> <text>A non-shedding coverall or gown;</text> </paragraph> <paragraph num="(b)"> <text>Head and facial hair covers;</text> </paragraph> <paragraph num="(c)"> <text>A face mask; and</text> </paragraph> <paragraph num="(d)"> <text>Shoe covers;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Clean room garb, with the exception of sterile gloves, shall be donned and removed outside the designated clean room area;</text> </paragraph> <paragraph num="(5)"> <text>All jewelry shall be removed;</text> </paragraph> <paragraph num="(6)"> <text>Sterile gloves are required; and</text> </paragraph> <paragraph num="(7)"> <text>Make-up may not be worn in the clean room.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The requirements of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with USP 797 Standards and isolator vendor/manufacturer specifications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Training of Staff, Patient, and Caregiver."> <paragraph num="A."> <text>The pharmacist shall make counseling available to the patient or primary caregiver, or both, concerning proper use of compounded sterile preparations and related supplies furnished by the pharmacy.</text> </paragraph> <paragraph num="B."> <text>The permit holder shall ensure that pharmacy personnel engaging in compounding sterile preparations are trained and demonstrate competence in the safe handling and compounding of compounded sterile preparations and parenteral solutions, including cytotoxic agents if applicable.</text> </paragraph> <paragraph num="C."> <text>The permit holder shall maintain records of training and demonstrated competence for individual employees for 5 years.</text> </paragraph> <paragraph num="D."> <text>The permit holder shall ensure the continuing competence of pharmacy personnel engaged in compounding sterile preparations.</text> </paragraph> <paragraph num="E."> <text>A pharmacy that compounds sterile preparations shall comply with the following training requirements:</text> <paragraph num="(1)"> <text>The pharmacy shall establish and follow a written program of training and performance evaluation designed to ensure that individuals working in the designated area have the knowledge and skills necessary to perform the assigned tasks properly and include at least the following:</text> <paragraph num="(a)"> <text>Aseptic technique with media fill verification at a frequency defined by risk level as described in USP 797 Standards:</text> <paragraph num="(i)"> <text>12 months for low and medium risk; and</text> </paragraph> <paragraph num="(ii)"> <text>6 months for high risk;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Pharmaceutical calculations and terminology;</text> </paragraph> <paragraph num="(c)"> <text>Compounding sterile preparation documentation process;</text> </paragraph> <paragraph num="(d)"> <text>Quality assurance procedures;</text> </paragraph> <paragraph num="(e)"> <text>Aseptic preparation procedures;</text> </paragraph> <paragraph num="(f)"> <text>Proper cleansing, gowning, and gloving techniques;</text> </paragraph> <paragraph num="(g)"> <text>General conduct in the controlled area;</text> </paragraph> <paragraph num="(h)"> <text>Cleaning, sanitizing, and maintaining equipment used in the controlled area;</text> </paragraph> <paragraph num="(i)"> <text>Sterilization techniques for high risk preparations; and</text> </paragraph> <paragraph num="(j)"> <text>Container, equipment, and closure system selection.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individuals assigned to the controlled area shall successfully complete practical skills training in aseptic technique and aseptic area practices.</text> </paragraph> <paragraph num="(3)"> <text>Evaluations shall include:</text> <paragraph num="(a)"> <text>Written testing;</text> </paragraph> <paragraph num="(b)"> <text>Observation for adherence to aseptic technique and aseptic area policies and procedures; and</text> </paragraph> <paragraph num="(c)"> <text>Media fill verification as set forth in §E(1)(a) of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Quality Assurance."> <text>The permit holder shall ensure that the compounded sterile preparation retains its potency and sterility throughout the assigned “beyond use” dating period through a written quality assurance program that includes:</text> <paragraph num="A."> <text>A reasonable effort by the pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions before dispensing, during transport, and at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration, as set forth by the product manufacturer and established standards and literature, with each compounded sterile preparation dispensed;</text> </paragraph> <paragraph num="B."> <text>The phases of compounded sterile preparation, distribution, storage, administration, and directions for use for each type of preparation dispensed;</text> </paragraph> <paragraph num="C."> <text>Environmental sampling for microbial organisms in laminar air flow workstations and clean rooms is performed according to methods and schedules specified by USP 797 Standards and if microbial contamination is suspected, for example, in the event of positive media fill verification results;</text> </paragraph> <paragraph num="D."> <text>Laminar air flow workstations, biological safety cabinets, and compounding aseptic isolators certified by a trained and qualified operator;</text> </paragraph> <paragraph num="E."> <text>Clean room and anteroom certification by a trained and qualified operator according to USP 797 Standards;</text> </paragraph> <paragraph num="F."> <text>The proper disposal in accordance with accepted professional standards and applicable State and federal laws of unused drugs and materials used in the preparation of compounded sterile preparations, including antineoplastic agents and hazardous materials;</text> </paragraph> <paragraph num="G."> <text>A formal written review process to report and evaluate compliance with this chapter; and</text> </paragraph> <paragraph num="H."> <text>A process that complies with applicable USP 797 Standards for performing sterility checks or pyrogen testing, or both, for applicable compounded sterile preparations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Reference Library."> <text>Minimum reference materials in a pharmacy shall include:</text> <paragraph num="A."> <text>U.S. Pharmaceutical, General Chapter 797, Pharmaceutical Compounding — Sterile Preparations and other applicable reference materials in order to perform sterile compounding;</text> </paragraph> <paragraph num="B."> <text>Reference materials containing drug stability and compatibility data; and</text> </paragraph> <paragraph num="C."> <text>Reference materials concerning drug interactions and incompatibility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Minimum Requirements for Inspections."> <paragraph num="A."> <text>The Board shall inspect pharmacies located in Maryland at least annually.</text> </paragraph> <paragraph num="B."> <text>The pharmacy shall provide as part of the inspection process:</text> <paragraph num="(1)"> <text>Quality assurance testing reports;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of reporting adverse events as required in Regulation .18 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and</text> </paragraph> <paragraph num="(4)"> <text>Any other information requested to ensure compliance with USP 797 Standards.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Within 90 days before the date of application, inspections of nonresident pharmacies may be conducted by:</text> <paragraph num="(1)"> <text>A designee of the Board;</text> </paragraph> <paragraph num="(2)"> <text>The U.S. Food and Drug Administration; or</text> </paragraph> <paragraph num="(3)"> <text>Another appropriate state entity which indicates compliance with USP 797 Standards.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board or designee shall inspect nonresident pharmacies upon initial application and upon renewal.</text> </paragraph> <paragraph num="E."> <text>The Board may inspect a pharmacy at any time to:</text> <paragraph num="(1)"> <text>Verify compliance with permit requirements; or</text> </paragraph> <paragraph num="(2)"> <text>Investigate a complaint.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Reporting Requirements Pharmacies."> <text>A pharmacy shall:</text> <paragraph num="A."> <text>Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and</text> </paragraph> <paragraph num="B."> <text>Report to the Board within 5 calendar days:</text> <paragraph num="(1)"> <text>Adverse events that have been discovered including corrective actions taken or proposed;</text> </paragraph> <paragraph num="(2)"> <text>Deficiencies related to the sterile compounding process;</text> </paragraph> <paragraph num="(3)"> <text>Disciplinary actions in other states or by other state agencies;</text> </paragraph> <paragraph num="(4)"> <text>Changes in accreditation status;</text> </paragraph> <paragraph num="(5)"> <text>Disciplinary actions taken against a pharmacist who is an owner, operator, or employee of the pharmacy; and</text> </paragraph> <paragraph num="(6)"> <text>Disciplinary actions taken against any other known permit, or any other authorization, held by the pharmacy permit holder.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Office Use."> <text>Unless otherwise authorized, a person that prepares and distributes sterile compounded medications for office use into, out of, or within the State shall hold:</text> <paragraph num="A."> <text>A manufacturer’s permit or other permit designated by the U.S. Food and Drug Administration to ensure the safety of sterile compounded medications for office use; and</text> </paragraph> <paragraph num="B."> <text>If applicable, a wholesale distributor’s permit, issued by the Board under Health Occupations Article, Title 12, Subtitle 6C, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 19, 1990 (17:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 20, 1992 (19:14 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06 repealed and new Regulations .01 — .16 adopted effective September 10, 2007 (34:18 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 23, 2009 (36:4 Md. R. 354); February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14E amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15C, E amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective February 23, 2009 (36:4 Md. R. 354)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted effective February 1, 2016 (43:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 adopted effective February 1, 2016 (43:2 Md. R. 127)</annotation> </annotations> </chapter> <chapter num="20" heading="Format of Prescription Transmission"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to the conveyance or transmission of prescription orders from authorized prescribers to pharmacies in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Prescription Validity."> <paragraph num="A."> <text>A valid prescription shall be:</text> <paragraph num="(1)"> <text>Valid in the professional judgment of the pharmacist responsible for filling the prescription; and</text> </paragraph> <paragraph num="(2)"> <text>Conveyed:</text> <paragraph num="(a)"> <text>In a manner that contains the handwritten, pen-to-paper signature of the prescriber;</text> </paragraph> <paragraph num="(b)"> <text>In a manner that is transmitted to the pharmacy electronically, provided that the prescription is:</text> <paragraph num="(i)"> <text>Transmitted via electronic intermediaries that are certified by the Maryland Health Care Commission;</text> </paragraph> <paragraph num="(ii)"> <text>Received by the permit holder’s computer, facsimile machine, or other electronic device; and</text> </paragraph> <paragraph num="(iii)"> <text>Maintained by the permit holder in accordance with Regulation .03 of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In an oral manner where:</text> <paragraph num="(i)"> <text>Only a pharmacist may take an original oral prescription by a voice messaging system or by phone with the pharmacist reading back the prescription to the prescriber or the prescriber’s agent; and</text> </paragraph> <paragraph num="(ii)"> <text>The pharmacist promptly reduces the oral prescription to writing.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The requirement of §A(2)(b)(i) of this regulation does not apply to prescriptions transmitted electronically within:</text> <paragraph num="(1)"> <text>A closed system of a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Any other closed system that does not utilize an intermediary for transmission of prescriptions.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prescription Records."> <text>The pharmacy permit holder shall maintain prescription records in a form that:</text> <paragraph num="A."> <text>Is readily and accurately retrievable;</text> </paragraph> <paragraph num="B."> <text>Is maintained for at least 5 years from the date of dispensing; and</text> </paragraph> <paragraph num="C."> <text>Protects the confidentiality and security of the prescription information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Controlled Dangerous Substances."> <text>Transmission and dispensing of controlled dangerous substances shall be in accordance with applicable State and federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 24, 1990 (17:25 Md. R. 2908)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 18, 1995 (22:25 Md. R. 1962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 18, 1995 (22:25 Md. R. 1962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective December 18, 1995 (22:25 Md. R. 1962)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05, Prescription Orders Submitted by Facsimile Devices, repealed and Regulations .01—.04, Format of Prescription Transmission, adopted effective December 25, 2000 (27:25 Md. R. 2282)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 4, 2010 (37:20 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 4, 2010 (37:20 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 4, 2010 (37:20 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 4, 2010 (37:20 Md. R. 1394)</annotation> </annotations> </chapter> <chapter num="21" heading="Standard of Practice for Unlicensed Personnel"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards of practice and the responsibilities of licensed pharmacists and pharmacy permit holders when using unlicensed personnel in the prescription area of a pharmacy.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Operational support” means tasks performed by:</text> <paragraph num="(a)"> <text>An administrative clerk;</text> </paragraph> <paragraph num="(b)"> <text>A billing clerk;</text> </paragraph> <paragraph num="(c)"> <text>A cashier;</text> </paragraph> <paragraph num="(d)"> <text>Delivery personnel;</text> </paragraph> <paragraph num="(e)"> <text>A file clerk;</text> </paragraph> <paragraph num="(f)"> <text>An inventory control clerk; or</text> </paragraph> <paragraph num="(g)"> <text>An individual engaged in janitorial services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Permit holder” means a person or corporation or other legal entity holding a permit issued by the Board to establish and operate a pharmacy.</text> </paragraph> <paragraph num="(4)"> <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Prescription area” means that portion of an establishment to which a pharmacy permit has been issued, which contains:</text> <paragraph num="(a)"> <text>Prescription drugs;</text> </paragraph> <paragraph num="(b)"> <text>Prescription devices; and</text> </paragraph> <paragraph num="(c)"> <text>Patient records.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Supervision” means the on-site provision of management, direction, oversight, and review of tasks assigned to personnel.</text> </paragraph> <paragraph num="(7)"> <text>“Unlicensed personnel” means individuals employed by the permit holder who provide operational support in the prescription area under the supervision of a licensed pharmacist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Duties of the Permit Holder."> <text>The permit holder shall:</text> <paragraph num="A."> <text>Determine which operational support tasks the pharmacist may assign unlicensed personnel to perform in the prescription area;</text> </paragraph> <paragraph num="B."> <text>Ensure that unlicensed personnel:</text> <paragraph num="(1)"> <text>Receive appropriate training for the tasks that the pharmacist assigns unlicensed personnel to perform in the prescription area;</text> </paragraph> <paragraph num="(2)"> <text>Receive training that will enable unlicensed personnel to understand how the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, apply to:</text> <paragraph num="(a)"> <text>Prescription records, and</text> </paragraph> <paragraph num="(b)"> <text>The requirements for confidentiality of patient specific information; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When performing tasks in the prescription area, maintain proper:</text> <paragraph num="(a)"> <text>Sanitation;</text> </paragraph> <paragraph num="(b)"> <text>Hygiene;</text> </paragraph> <paragraph num="(c)"> <text>Biohazard precautions; and</text> </paragraph> <paragraph num="(d)"> <text>Infection control; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Ensure that unlicensed personnel are clearly identified to the consumer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Duties of the Pharmacist."> <paragraph num="A."> <text>The pharmacist shall provide supervision to unlicensed personnel.</text> </paragraph> <paragraph num="B."> <text>The pharmacist may not delegate any pharmacy acts to unlicensed personnel.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Duties of Unlicensed Personnel."> <paragraph num="A."> <text>Unlicensed personnel under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in the prescription area.</text> </paragraph> <paragraph num="B."> <text>Unlicensed personnel who perform duties in the prescription area shall maintain the confidentiality of patient specific data in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Grounds for Discipline."> <paragraph num="A."> <text>A pharmacist licensee may be subject to discipline if the pharmacist licensee violates any provision of Regulation .04 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A permit holder may be subject to disciplinary action if:</text> <paragraph num="(1)"> <text>The permit holder fails to take reasonable safeguards to ensure compliance with the regulations of the Board; or</text> </paragraph> <paragraph num="(2)"> <text>The permit holder otherwise violates any of the provisions of Regulation .03 of this chapter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 5, 2001 (28:4 Md. R. 419)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 10, 2001 (28:24 Md. R. 2128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective November 25, 2002 (29:23 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127)</annotation> </annotations> </chapter> <chapter num="22" heading="Licensing of Wholesale Prescription Drug or Device Distributors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to any person engaged in the wholesale distribution of prescription drugs or devices in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ANDA” means an Abbreviated New Drug Application number and contains data that, when submitted to the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.</text> </paragraph> <paragraph num="(1-1)"> <text>“Authenticate” means to affirmatively verify, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree for the prescription drug has occurred.</text> </paragraph> <paragraph num="(2)"> <text>“Authorized distributor of record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug.</text> </paragraph> <paragraph num="(3)"> <text>“Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing.</text> </paragraph> <paragraph num="(4)"> <text>“Blood component” means that part of blood separated by physical or mechanical means.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(5-1)"> <text>“Cease to operate” means the date on which the last prescription drug or prescription device is distributed by the permit holder.</text> </paragraph> <paragraph num="(5-2)"> <text>“Central repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(6)"> <text>“Co-licensed partner” means a person in a relationship in which two or more persons have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the U.S. Food and Drug Administration's implementation of the Federal Prescription Drug Marketing Act.</text> </paragraph> <paragraph num="(7)"> <text>“DEA” means the U. S. Drug Enforcement Administration.</text> </paragraph> <paragraph num="(8)"> <text>“Designated representative” means an individual who:</text> <paragraph num="(a)"> <text>Is designated by the wholesale distributor;</text> </paragraph> <paragraph num="(b)"> <text>Serves as the primary contact of the wholesale distributor with the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Is actively involved in, and aware of, the daily operation of the wholesale distributor.</text> </paragraph> </paragraph> <paragraph num="(8-1)"> <text>“Designee” means a Board contracted or Board recognized entity.</text> </paragraph> <paragraph num="(9)"> <text>“Drop shipment” means the sale of a prescription drug:</text> <paragraph num="(a)"> <text>To a wholesale distributor by:</text> <paragraph num="(i)"> <text>The manufacturer of the prescription drug; or</text> </paragraph> <paragraph num="(ii)"> <text>The manufacturer's co-licensed partner, third-party logistics provider, or manufacturer's exclusive distributor; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Through which:</text> <paragraph num="(i)"> <text>The wholesale distributor or a pharmacy warehouse takes title to, but not physical possession of, the prescription drug;</text> </paragraph> <paragraph num="(ii)"> <text>The wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the prescription drug to a patient; and</text> </paragraph> <paragraph num="(iii)"> <text>The pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer, the manufacturer's third-party logistics provider, or the manufacturer's exclusive distributor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“FDA” means the U. S. Food and Drug Administration.</text> </paragraph> <paragraph num="(11)"> <text>“Gross receipts” means gross receipts from sales of prescription drugs and devices in the State.</text> </paragraph> <paragraph num="(12)"> <text>Health Care Entity.</text> <paragraph num="(a)"> <text>“Health care entity” means a person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care.</text> </paragraph> <paragraph num="(b)"> <text>“Health care entity” does not include a community pharmacy or a wholesale distributor.</text> </paragraph> <paragraph num="(c)"> <text>“Health care entity” may not simultaneously be a health care entity and a community pharmacy or wholesale distributor.</text> </paragraph> </paragraph> <paragraph num="(12-1)"> <text>“Intracompany sales” means a:</text> <paragraph num="(a)"> <text>Transaction or transfer of prescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity, other than a transaction or transfer of prescription drugs from a pharmacy to a wholesale distributor; or</text> </paragraph> <paragraph num="(b)"> <text>Transaction or transfer of a co–licensed product between co–licensed partners.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Manufacturer” means a person licensed or approved by the U.S. Food and Drug Administration to engage in the manufacture of prescription drugs or prescription devices, consistent with the definition of “Manufacturer” under the U.S. Food and Drug Administration's regulations and guidelines implementing the Prescription Drug Marketing Act.</text> </paragraph> <paragraph num="(14)"> <text>“Manufacturer's exclusive distributor” means a person who:</text> <paragraph num="(a)"> <text>Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and</text> </paragraph> <paragraph num="(b)"> <text>Takes title to the manufacturer's prescription drug, but does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug.</text> </paragraph> </paragraph> <paragraph num="(14-1)"> <text>“NDA” means a New Drug Application number assigned by the FDA for drugs formally proposed to the FDA as a new pharmaceutical for sale and marketing in the U.S.</text> </paragraph> <paragraph num="(15)"> <text>“Normal distribution channel” means a chain of custody for a prescription drug that, directly or by drop shipment, goes:</text> <paragraph num="(a)"> <text>From:</text> <paragraph num="(i)"> <text>A manufacturer of the prescription drug; or</text> </paragraph> <paragraph num="(ii)"> <text>The manufacturer's co-licensed partner, third-party logistics provider, or manufacturer's exclusive distributor; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>To:</text> <paragraph num="(i)"> <text>A pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </paragraph> <paragraph num="(ii)"> <text>A wholesale distributor to a pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </paragraph> <paragraph num="(iii)"> <text>A wholesale distributor to a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy, or other designated person authorized by law to dispense or administer the prescription drug to a patient; or</text> </paragraph> <paragraph num="(v)"> <text>An authorized distributor of record to another authorized distributor of record solely for distribution to an office-based health care practitioner authorized by law to dispense or administer the prescription drug to a patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Pedigree” means a document or electronic file containing information that records each wholesale distribution of a prescription drug.</text> </paragraph> <paragraph num="(16-1)"> <text>“Pharmacy” means a pharmacy that has been issued a:</text> <paragraph num="(a)"> <text>Waiver pharmacy permit in accordance with COMAR 10.34.17; or</text> </paragraph> <paragraph num="(b)"> <text>Full service pharmacy permit.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Prescription device” means any device required by federal law or regulation to be dispensed only by a prescription.</text> </paragraph> <paragraph num="(18)"> <text>Prescription Drug.</text> <paragraph num="(a)"> <text>“Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription.</text> </paragraph> <paragraph num="(b)"> <text>“Prescription drug” includes:</text> <paragraph num="(i)"> <text>A biological product; and</text> </paragraph> <paragraph num="(ii)"> <text>Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug and Cosmetic Act.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices.</text> </paragraph> </paragraph> <paragraph num="(18-1)"> <text>“Reinstatement” means renewal of a wholesale distributor permit after the permit has expired.</text> </paragraph> <paragraph num="(18-2)"> <text>“Renewal” means renewing a wholesale distributor permit before the date of expiration.</text> </paragraph> <paragraph num="(19)"> <text>Repackage.</text> <paragraph num="(a)"> <text>“Repackage” means to repackage or otherwise change the container, wrapper, or labeling of a prescription drug to further the distribution of the prescription drug.</text> </paragraph> <paragraph num="(b)"> <text>“Repackage” does not include changes to a container, wrapper, or labeling of a prescription drug completed by the pharmacist responsible for dispensing the prescription drug to a patient.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Repackager” means a person who repackages prescription drugs.</text> </paragraph> <paragraph num="(21)"> <text>“Third-party logistics provider” means a person who:</text> <paragraph num="(a)"> <text>Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and</text> </paragraph> <paragraph num="(b)"> <text>Does not take title to the prescription drug, or have general responsibility to direct the prescription drug's sale or disposition.</text> </paragraph> </paragraph> <paragraph num="(21-1)"> <text>“UDI” means a Unique Device Identification number that is created through a globally accepted device identification and coding standard that allows the unambiguous identification of a specific medical device.</text> </paragraph> <paragraph num="(21-2)"> <text>Virtual Manufacturer.</text> <paragraph num="(a)"> <text>“Virtual Manufacturer” means an entity that engages in the manufacture of drug or device products for which it:</text> <paragraph num="(i)"> <text>Owns the NDA or ANDA number, if a prescription drug;</text> </paragraph> <paragraph num="(ii)"> <text>Owns the UDI number, as available, for a prescription device;</text> </paragraph> <paragraph num="(iii)"> <text>Contracts with a contract manufacturing organization for the physical manufacture of the drug or device product;</text> </paragraph> <paragraph num="(iv)"> <text>Is not involved in the physical manufacture of the drug or device product; and</text> </paragraph> <paragraph num="(v)"> <text>At no time takes physical possession of, or stores, the drug or device product.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Virtual Manufacturer” may include entities that are identified as a broker, own-label distributor, sponsor manufacturer, private-label manufacturer, or contract manufacturer.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Wholesale Distribution.</text> <paragraph num="(a)"> <text>“Wholesale distribution” means the distribution of prescription drugs or prescription devices to persons other than a consumer or patient.</text> </paragraph> <paragraph num="(b)"> <text>“Wholesale distribution” does not include:</text> <paragraph num="(i)"> <text>Intracompany sales;</text> </paragraph> <paragraph num="(ii)"> <text>The sale, purchase, distribution, trade, or transfer of a prescription drug or an offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons which include transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;</text> </paragraph> <paragraph num="(iii)"> <text>The distribution of samples of a prescription drug by a manufacturer's representative;</text> </paragraph> <paragraph num="(iv)"> <text>Prescription drug returns conducted by a hospital, health care entity, or charitable institution in accordance with 21 CFR §203.23, as amended;</text> </paragraph> <paragraph num="(v)"> <text>The sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use;</text> </paragraph> <paragraph num="(vi)"> <text>The sale, purchase, or trade of a prescription drug, an offer to sell, purchase, or trade a prescription drug, or the dispensing of a prescription drug in accordance with a prescription;</text> </paragraph> <paragraph num="(vii)"> <text>The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy to or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets;</text> </paragraph> <paragraph num="(viii)"> <text>The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer has stated in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the prescription drug, and the supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel;</text> </paragraph> <paragraph num="(ix)"> <text>The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug; or</text> </paragraph> <paragraph num="(x)"> <text>The sale or transfer from a pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original wholesale distributor, the original manufacturer, or a third-party returns processor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>Wholesale Distributor.</text> <paragraph num="(a)"> <text>“Wholesale distributor” means a person that is engaged in the wholesale distribution of prescription drugs or prescription devices.</text> </paragraph> <paragraph num="(b)"> <text>“Wholesale distributor” includes:</text> <paragraph num="(i)"> <text>A manufacturer;</text> </paragraph> <paragraph num="(ii)"> <text>A repackager;</text> </paragraph> <paragraph num="(iii)"> <text>An own-label distributor;</text> </paragraph> <paragraph num="(iv)"> <text>A private-label distributor;</text> </paragraph> <paragraph num="(v)"> <text>A jobber;</text> </paragraph> <paragraph num="(vi)"> <text>A broker;</text> </paragraph> <paragraph num="(vii)"> <text>A warehouse, including a manufacturer's or distributor's warehouse;</text> </paragraph> <paragraph num="(viii)"> <text>A manufacturer's exclusive distributor, or an authorized distributor of record;</text> </paragraph> <paragraph num="(ix)"> <text>A drug wholesaler or distributor;</text> </paragraph> <paragraph num="(x)"> <text>An independent wholesale drug trader;</text> </paragraph> <paragraph num="(xi)"> <text>A third-party logistics provider;</text> </paragraph> <paragraph num="(xii)"> <text>A pharmacy that conducts wholesale distribution, if the wholesale distribution business accounts for more than 5 percent of the pharmacy's annual sales; and</text> </paragraph> <paragraph num="(xiii)"> <text>A pharmacy warehouse that conducts wholesale distribution.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Minimum Application Requirements for Virtual Manufacturers."> <text>The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requirements:</text> <paragraph num="A."> <text>Provides a list of drug or device products it distributes;</text> </paragraph> <paragraph num="B."> <text>Provides a list of the NDA or ANDA numbers associated with each drug it distributes;</text> </paragraph> <paragraph num="C."> <text>Provides a list of the UDI numbers, as available, associated with each device it distributes;</text> </paragraph> <paragraph num="D."> <text>Provides the name and facility address of the contract manufacturer for each drug or device product it distributes;</text> </paragraph> <paragraph num="E."> <text>Provides verification of current FDA registration for each contract manufacturing facility listed;</text> </paragraph> <paragraph num="F."> <text>If the contract manufacturer distributes into this State, provides the wholesale distributor permit number for the contract manufacturer;</text> </paragraph> <paragraph num="G."> <text>If the contract manufacturer does not distribute into this State, provides name and Maryland’s wholesale distributor permit number for the entity that physically distributes the product into this State;</text> </paragraph> <paragraph num="H."> <text>Provides a statement affirming that the virtual manufacturer does not contract the manufacture or distribution for drugs or devices other than those for which it owns the NDA, ANDA, or UDI numbers;</text> </paragraph> <paragraph num="I."> <text>Provides an attestation by the owner of the virtual manufacturer that it does not hold product;</text> </paragraph> <paragraph num="J."> <text>Provides a copy of existing licensure from the state in which it is located, if applicable; and</text> </paragraph> <paragraph num="K."> <text>Has valid federal licensure or registration, as verified by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Minimum Application Requirements for Applicants Holding Product."> <paragraph num="A."> <text>The Board shall require the following minimum information from a wholesale distributor as part of an application for a permit and as part of a renewal of a permit:</text> <paragraph num="(1)"> <text>The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship;</text> </paragraph> <paragraph num="(2)"> <text>The full name or names of the owner and the operator of the wholesale distributor applying for or renewing a permit, including:</text> <paragraph num="(a)"> <text>For an individual, the:</text> <paragraph num="(i)"> <text>Full name of the individual;</text> </paragraph> <paragraph num="(ii)"> <text>Telephone number of the individual;</text> </paragraph> <paragraph num="(iii)"> <text>Business address of the individual; and</text> </paragraph> <paragraph num="(iv)"> <text>Date of birth of the individual;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For a partnership, the:</text> <paragraph num="(i)"> <text>Full name of each partner;</text> </paragraph> <paragraph num="(ii)"> <text>Telephone number of the partnership;</text> </paragraph> <paragraph num="(iii)"> <text>Address of each partner;</text> </paragraph> <paragraph num="(iv)"> <text>Date of birth of each partner;</text> </paragraph> <paragraph num="(v)"> <text>Business address of the partnership; and</text> </paragraph> <paragraph num="(vi)"> <text>Federal employer identification number of the partnership;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For a publicly traded corporation, the:</text> <paragraph num="(i)"> <text>Full name and title of each corporate officer and director;</text> </paragraph> <paragraph num="(ii)"> <text>Telephone number of the publicly traded corporation;</text> </paragraph> <paragraph num="(iii)"> <text>Business address of the corporation;</text> </paragraph> <paragraph num="(iv)"> <text>Federal employer identification number of the corporation;</text> </paragraph> <paragraph num="(v)"> <text>Name of parent company or companies if applicable;</text> </paragraph> <paragraph num="(vi)"> <text>Corporate names;</text> </paragraph> <paragraph num="(vii)"> <text>Name of the state of incorporation; and</text> </paragraph> <paragraph num="(viii)"> <text>Name and address of the resident agent of the corporation;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For a nonpublicly traded corporation, the:</text> <paragraph num="(i)"> <text>Full name and title of each corporate officer and director;</text> </paragraph> <paragraph num="(ii)"> <text>The telephone number of the nonpublicly traded corporation;</text> </paragraph> <paragraph num="(iii)"> <text>Business address of the corporation;</text> </paragraph> <paragraph num="(iv)"> <text>Federal employer identification number of the corporation;</text> </paragraph> <paragraph num="(v)"> <text>Name of parent company or companies if applicable;</text> </paragraph> <paragraph num="(vi)"> <text>Corporate names;</text> </paragraph> <paragraph num="(vii)"> <text>Full name and business address of shareholders of more than 10 percent of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange;</text> </paragraph> <paragraph num="(viii)"> <text>Name of the state of incorporation; and</text> </paragraph> <paragraph num="(ix)"> <text>Name and address of the resident agent of the corporation;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>For a sole proprietorship, the:</text> <paragraph num="(i)"> <text>Full name of the sole proprietor;</text> </paragraph> <paragraph num="(ii)"> <text>The telephone number of the sole proprietor;</text> </paragraph> <paragraph num="(iii)"> <text>Full name of the business entity;</text> </paragraph> <paragraph num="(iv)"> <text>Business address; and</text> </paragraph> <paragraph num="(v)"> <text>Date of birth of the sole proprietor;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>For a limited liability company, the:</text> <paragraph num="(i)"> <text>Full name and business address of the limited liability company;</text> </paragraph> <paragraph num="(ii)"> <text>Telephone number of the limited liability company;</text> </paragraph> <paragraph num="(iii)"> <text>Full name of each member;</text> </paragraph> <paragraph num="(iv)"> <text>Full name of each manager;</text> </paragraph> <paragraph num="(v)"> <text>Federal employer identification number of the limited liability company;</text> </paragraph> <paragraph num="(vi)"> <text>Name of the state in which the limited liability company was organized; and</text> </paragraph> <paragraph num="(vii)"> <text>Name and address of the resident agent of the company;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs;</text> </paragraph> <paragraph num="(4)"> <text>All trade or business names used by the permit holder which may not be identical to the name used by another unrelated applicant in the State;</text> </paragraph> <paragraph num="(5)"> <text>A list of federal and state licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by federal authority or another state that authorizes the wholesale distributor to purchase, possess, and distribute prescription drugs or devices;</text> </paragraph> <paragraph num="(6)"> <text>A list of disciplinary actions by federal or state agencies against the wholesale distributor as well as any such actions against principals, owners, directors, or officers;</text> </paragraph> <paragraph num="(7)"> <text>For the designated representative and the immediate supervisor of the designated representative at the applicant's place of business the following information:</text> <paragraph num="(a)"> <text>Names;</text> </paragraph> <paragraph num="(b)"> <text>Places of residence for the past 7 years;</text> </paragraph> <paragraph num="(c)"> <text>Dates and places of birth;</text> </paragraph> <paragraph num="(d)"> <text>The name and address of each business where the individual was employed during the past 7 years, and the individual's job title or office held at each business;</text> </paragraph> <paragraph num="(e)"> <text>A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding;</text> </paragraph> <paragraph num="(f)"> <text>A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event;</text> </paragraph> <paragraph num="(g)"> <text>A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years, with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party;</text> </paragraph> <paragraph num="(h)"> <text>A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of the guilt was withheld or whether the individual pled guilty or nolo contendere;</text> </paragraph> <paragraph num="(i)"> <text>If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and</text> </paragraph> <paragraph num="(j)"> <text>A photograph of the individual taken in the previous 180 days;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A full description of the facility and warehouse including:</text> <paragraph num="(a)"> <text>Square footage;</text> </paragraph> <paragraph num="(b)"> <text>Security and alarm system descriptions;</text> </paragraph> <paragraph num="(c)"> <text>Terms of lease or ownership;</text> </paragraph> <paragraph num="(d)"> <text>Address; and</text> </paragraph> <paragraph num="(e)"> <text>Description of temperature and humidity controls;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Written evidence that the wholesale distributor has obtained general and product liability insurance;</text> </paragraph> <paragraph num="(10)"> <text>A description of the wholesale distributor's import and export activities; and</text> </paragraph> <paragraph num="(11)"> <text>Other relevant information that the Board may require.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Criminal Background Check Requirements for an Applicant Located in this State. The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to the Central Repository and the Federal Bureau of Investigation:</text> <paragraph num="(1)"> <text>Electronically or digitally captured fingerprints at approved electronic fingerprint locations approved by the Director of the Central Repository;</text> </paragraph> <paragraph num="(2)"> <text>The fee authorized under the Criminal Procedure Article, §10-221(b)(7), Annotated Code of Maryland, for access to State criminal history records; and</text> </paragraph> <paragraph num="(3)"> <text>The processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text> </paragraph> </paragraph> <paragraph num="B-1."> <text>Criminal Background Check Requirements for an Applicant Located Outside this State.</text> <paragraph num="(1)"> <text>The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to a criminal history records check by the applicant’s state of residence, in accordance with the laws of the applicant’s state of residence.</text> </paragraph> <paragraph num="(2)"> <text>The criminal history records check shall consist of:</text> <paragraph num="(a)"> <text>A state criminal history records check for the applicant’s state of residence; and</text> </paragraph> <paragraph num="(b)"> <text>A national criminal history records check.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant’s state of residence to forward the results of the criminal history records check to the Board and the applicant.</text> </paragraph> <paragraph num="(4)"> <text>If the appropriate entity in the applicant’s state of residence is unable to forward the results of the criminal history records check, then the designated representative and the immediate supervisor of the designated representative of an applicant shall ensure that the results of the criminal history records check are forwarded to the Board in a manner approved by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The information required under §A of this regulation shall be provided under oath.</text> </paragraph> <paragraph num="D."> <text>The Board may not issue an initial or renewal wholesale distributor permit to an applicant unless the Board or its designee:</text> <paragraph num="(1)"> <text>If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant's place of business, including any facility of the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Finds that the place of business and facility, if any, meets the Board's requirements;</text> </paragraph> <paragraph num="(3)"> <text>Determines that the designated representative of the applicant meets the following qualifications:</text> <paragraph num="(a)"> <text>Is 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text> </paragraph> <paragraph num="(c)"> <text>Is employed by the applicant full time in a managerial level position;</text> </paragraph> <paragraph num="(d)"> <text>Is actively involved in, and aware of, the daily operation of the wholesale distributor;</text> </paragraph> <paragraph num="(e)"> <text>Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours;</text> </paragraph> <paragraph num="(f)"> <text>Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in §1504 of the Internal Revenue Code;</text> </paragraph> <paragraph num="(g)"> <text>Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and</text> </paragraph> <paragraph num="(h)"> <text>Does not have any convictions for a felony under federal, State, or local laws; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications:</text> <paragraph num="(a)"> <text>Is 21 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text> </paragraph> <paragraph num="(c)"> <text>Is employed by the applicant full time in a managerial level position;</text> </paragraph> <paragraph num="(d)"> <text>Is actively involved in, and aware of, the daily operation of the wholesale distributor;</text> </paragraph> <paragraph num="(e)"> <text>Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution, or distribution of controlled substances; and</text> </paragraph> <paragraph num="(f)"> <text>Does not have any convictions for a felony under federal, state, or local laws.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Surety Bond.</text> <paragraph num="(1)"> <text>An applicant for a wholesale distributor permit shall submit a surety bond or other equivalent means of security acceptable to the State such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the State Board of Pharmacy to be deposited into an account established by the State under Health Occupations Article, §12-6C-05(f)(7), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The surety bond, or other security, shall be in the amount of:</text> <paragraph num="(a)"> <text>$100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or</text> </paragraph> <paragraph num="(b)"> <text>$50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant shall submit the following documentation to verify the applicant's annual gross receipts in the State are less than $10,000,000 for the previous tax year:</text> <paragraph num="(a)"> <text>A federal tax return; or</text> </paragraph> <paragraph num="(b)"> <text>An annual sales report specifying the sales of prescription drugs and devices in the State audited by a certified public accountant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A surety bond is not required for a pharmacy warehouse that is not engaged in wholesale distribution.</text> </paragraph> <paragraph num="(5)"> <text>An applicant shall obtain a surety bond for each facility.</text> </paragraph> <paragraph num="(6)"> <text>A single surety bond may cover all facilities operated by the applicant within this State.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility.</text> </paragraph> <paragraph num="G."> <text>The Board shall notify the applicant of the Board's acceptance or rejection of the application within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks.</text> </paragraph> <paragraph num="H."> <text>The applicant shall pay to the Board an application fee set forth in COMAR 10.34.09.02.</text> </paragraph> <paragraph num="I."> <text>The wholesale distributor shall provide changes in information provided pursuant to Regulation .03 of this chapter to the Board within 30 days of the effective date of the change.</text> </paragraph> <paragraph num="J."> <text>Information and qualification requirements for obtaining a permit under this regulation, beyond that required by federal law, does not apply to a manufacturer who distributes its own prescription:</text> <paragraph num="(1)"> <text>Drugs approved by the U.S. Food and Drug Administration; or</text> </paragraph> <paragraph num="(2)"> <text>Devices that are approved or authorized by the U.S. Food and Drug Administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Personnel."> <paragraph num="A."> <text>The permit holder shall affirm in the initial application and subsequent renewal applications that personnel employed in wholesale distribution have appropriate education and experience to assume responsibilities related to compliance with State licensing requirements.</text> </paragraph> <paragraph num="B."> <text>Registered Agent.</text> <paragraph num="(1)"> <text>Each licensed wholesale distributor located outside of this State that wholesale distributes prescription drugs or devices in this State shall designate a registered agent in this State for service of process.</text> </paragraph> <paragraph num="(2)"> <text>If any wholesale distributor is not licensed in this State, service on the Director of the State Department of Assessments and Taxation only shall be sufficient service.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Requirements and Responsibilities of the Designated Representative.</text> <paragraph num="(1)"> <text>The designated representative shall be aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the wholesale distributor, including applicable State and federal laws.</text> </paragraph> <paragraph num="(2)"> <text>The designated representative shall have documented training sufficient to ensure that operations of the wholesale distributor are in compliance with applicable State and federal laws and are provided by qualified in-house specialists, outside counsel, or consulting specialists with capabilities to help ensure compliance with all applicable State and federal laws and regulations.</text> </paragraph> <paragraph num="(3)"> <text>The designated representative shall maintain current working knowledge of the requirements for wholesale distributor and assure ongoing training for personnel to ensure compliance.</text> </paragraph> <paragraph num="(4)"> <text>The designated representative shall be responsible for all record keeping requirements and make all records available for inspection.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Violations and Penalties."> <paragraph num="A."> <text>After a hearing held under Health Occupations Article, §12-601, Annotated Code of Maryland, the Board may deny, suspend, revoke, or place on probation a permit holder, reprimand a permit holder, or impose a fine if the permit holder:</text> <paragraph num="(1)"> <text>Is convicted of, or pleads guilty or nolo contendere to, violations of federal, State, or local drug or device laws or regulations;</text> </paragraph> <paragraph num="(2)"> <text>Is convicted of, or pleads guilty or nolo contendere to, a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(3)"> <text>Commits any of the following acts:</text> <paragraph num="(a)"> <text>Obtains or attempts to obtain a permit by:</text> <paragraph num="(i)"> <text>Providing false information to the Board; or</text> </paragraph> <paragraph num="(ii)"> <text>Other fraudulent or deceptive means;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Fails to:</text> <paragraph num="(i)"> <text>Establish or maintain inventories, records, or written policies and procedures as required by Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Register with the Maryland Division of Drug Control, and with the U.S. Drug Enforcement Agency, as required by Regulation .07D of this chapter; or</text> </paragraph> <paragraph num="(iii)"> <text>Permit the Board, the Maryland Division of Drug Control, the U.S. Drug Enforcement Agency, or other authorized federal, State, or local law enforcement officials showing proper identification, to enter, inspect, copy records, or audit as required by Regulation .07D of this chapter;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Willfully makes or maintains false inventories or records;</text> </paragraph> <paragraph num="(d)"> <text>Violates a provision of, or regulation promulgated under, Health Occupations Article, Title 12, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Manufactures, repackages, sells, delivers, or holds or offers for sale any prescription drug or device that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or has otherwise been rendered unfit for distribution or wholesale distribution;</text> </paragraph> <paragraph num="(f)"> <text>Adulterates, misbrands, or counterfeits prescription drugs or devices;</text> </paragraph> <paragraph num="(g)"> <text>Receives prescription drugs or devices that are adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit, or delivers or proffers delivery of such prescription drug or device for pay or otherwise;</text> </paragraph> <paragraph num="(h)"> <text>Alters, mutilates, destroys, obliterates, or removes the whole or any part of the product labeling of a prescription drug or device, or commits any other act with respect to a prescription drug or device that results in the prescription drug or device being misbranded;</text> </paragraph> <paragraph num="(i)"> <text>Forges, counterfeits, simulates, or falsely represents prescription drugs or devices without the authority of the manufacturer, or uses any mark, stamp, tag, label, or other identification device without the authorization of the manufacturer;</text> </paragraph> <paragraph num="(j)"> <text>Purchases or receives a prescription drug or device from a person who is not licensed to wholesale distribute prescription drugs or devices to that purchaser or recipient;</text> </paragraph> <paragraph num="(k)"> <text>Sells or transfers a prescription drug or device to a person who is not legally authorized to receive a prescription drug or device;</text> </paragraph> <paragraph num="(l)"> <text>Provides the Board, its representatives, or federal or State officials with false or fraudulent records, or makes false or fraudulent statements regarding any matter within the provisions of these regulations;</text> </paragraph> <paragraph num="(m)"> <text>Wholesale distributes prescription drugs or devices that were:</text> <paragraph num="(i)"> <text>Purchased by a public or private hospital, or other health care entity;</text> </paragraph> <paragraph num="(ii)"> <text>Donated or supplied at a reduced price to a charitable organization;</text> </paragraph> <paragraph num="(iii)"> <text>Stolen or obtained by fraud or deceit; or</text> </paragraph> <paragraph num="(iv)"> <text>Donated to a drop-off site or repository under the Prescription Drug Repository Program set forth in Health-General Article, Title 15, Subtitle 6, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(n)"> <text>Fails to obtain a license, or operates without a valid license when a license is required;</text> </paragraph> <paragraph num="(o)"> <text>Obtains, or attempts to obtain, a prescription drug or device by fraud, deceit, misrepresentation, or engages in misrepresentation or fraud in the distribution or wholesale distribution of a prescription drug or device;</text> </paragraph> <paragraph num="(p)"> <text>Distributes a prescription drug or device to a consumer or patient;</text> </paragraph> <paragraph num="(q)"> <text>Fails to obtain, authenticate, or pass on a pedigree when required under these regulations;</text> </paragraph> <paragraph num="(r)"> <text>Receives a prescription drug pursuant to a wholesale distribution without first receiving a pedigree, when required, that was attested to as accurate and complete by the wholesale distributor;</text> </paragraph> <paragraph num="(s)"> <text>Distributes or wholesale distributes a prescription drug or device that was previously dispensed by a pharmacy or distributed by a practitioner;</text> </paragraph> <paragraph num="(t)"> <text>Fails to report prohibited acts as listed in these regulations;</text> </paragraph> <paragraph num="(u)"> <text>Fails to exercise due diligence as provided in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(v)"> <text>Otherwise conducts the wholesale distribution of prescription drugs or devices in a manner not in accordance with the law;</text> </paragraph> <paragraph num="(w)"> <text>Accepts payment or credit for the sale of prescription drugs in violation of Health Occupations Article, §12-6C-09(d), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(x)"> <text>If the requirements of Health Occupations Article, §12-6C-09(a), Annotated Code of Maryland, are applicable and are not met, the purchasing or otherwise receiving a prescription drug from a pharmacy; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is disciplined by a licensing or disciplinary authority of any state or country, or disciplined by a court of any state or country, for an act that would constitute a ground for Board action against a wholesale distributor permit holder under §A or B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Acts prohibited under this regulation do not include a prescription drug manufacturer, or agent of a prescription drug manufacturer, obtaining or attempting to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Minimum Requirements for the Storage and Handling of Prescription Drugs or Devices."> <paragraph num="A."> <text>Facilities. Facilities at which prescription drugs or devices are stored, warehoused, handled, held, offered, marketed, or displayed shall:</text> <paragraph num="(1)"> <text>Be of suitable size and construction to facilitate:</text> <paragraph num="(a)"> <text>Cleaning;</text> </paragraph> <paragraph num="(b)"> <text>Maintenance; and</text> </paragraph> <paragraph num="(c)"> <text>Proper operations;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have storage areas designed to provide adequate:</text> <paragraph num="(a)"> <text>Equipment;</text> </paragraph> <paragraph num="(b)"> <text>Humidity control;</text> </paragraph> <paragraph num="(c)"> <text>Lighting;</text> </paragraph> <paragraph num="(d)"> <text>Sanitation;</text> </paragraph> <paragraph num="(e)"> <text>Security conditions;</text> </paragraph> <paragraph num="(f)"> <text>Space;</text> </paragraph> <paragraph num="(g)"> <text>Temperature; and</text> </paragraph> <paragraph num="(h)"> <text>Ventilation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have a quarantine area for storage of prescription drugs or devices that are:</text> <paragraph num="(a)"> <text>Adulterated;</text> </paragraph> <paragraph num="(b)"> <text>Damaged;</text> </paragraph> <paragraph num="(c)"> <text>Deteriorated;</text> </paragraph> <paragraph num="(d)"> <text>In immediate or sealed secondary containers that have been opened;</text> </paragraph> <paragraph num="(e)"> <text>Misbranded; or</text> </paragraph> <paragraph num="(f)"> <text>Outdated;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be maintained in a clean and orderly condition; and</text> </paragraph> <paragraph num="(5)"> <text>Be free from infestation by insects, rodents, birds, or vermin.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Security. A facility:</text> <paragraph num="(1)"> <text>Used for wholesale distribution shall be secure from unauthorized entry as follows:</text> <paragraph num="(a)"> <text>Access from outside the premises shall be:</text> <paragraph num="(i)"> <text>Kept to a minimum; and</text> </paragraph> <paragraph num="(ii)"> <text>Well controlled;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The outside perimeter of the premises shall be well lit; and</text> </paragraph> <paragraph num="(c)"> <text>Entry into areas where prescription drugs or devices are held shall be limited to authorized personnel;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be equipped with:</text> <paragraph num="(a)"> <text>An alarm system to detect entry after hours;</text> </paragraph> <paragraph num="(b)"> <text>A security system that provides protection against theft and diversion;</text> </paragraph> <paragraph num="(c)"> <text>Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;</text> </paragraph> <paragraph num="(d)"> <text>An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;</text> </paragraph> <paragraph num="(e)"> <text>A security system to protect the integrity and confidentiality of data and documents;</text> </paragraph> <paragraph num="(f)"> <text>Video monitoring of all entrances and exits, or alternate acceptable security; and</text> </paragraph> <paragraph num="(g)"> <text>A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, or federal and other State law enforcement officials.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Storage.</text> <paragraph num="(1)"> <text>A wholesale distributor shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:</text> <paragraph num="(a)"> <text>If any, of the labeling of the drug or device; or</text> </paragraph> <paragraph num="(b)"> <text>Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF), under 21 CFR §205.50(c), as amended.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If no storage requirements are established for a prescription drug or device, the drug or device shall be held at a controlled room temperature, as defined in an official compendium as set forth in §C(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.</text> </paragraph> <paragraph num="(3)"> <text>A wholesale distributor shall use appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs to document proper storage of prescription drugs or devices.</text> </paragraph> <paragraph num="(4)"> <text>A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for stored prescription drugs or devices.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Examination of Materials.</text> <paragraph num="(1)"> <text>Upon receipt, a wholesale distributor shall visually examine each outside shipping container for identity and to prevent the acceptance of:</text> <paragraph num="(a)"> <text>Contaminated prescription drugs or devices; or</text> </paragraph> <paragraph num="(b)"> <text>Prescription drugs or devices that are otherwise unfit for distribution.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The examination required under §D(1) of this regulation shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.</text> </paragraph> <paragraph num="(3)"> <text>A wholesale distributor shall carefully inspect each outgoing shipment:</text> <paragraph num="(a)"> <text>For identity of the prescription drug or device product; and</text> </paragraph> <paragraph num="(b)"> <text>To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for incoming and outgoing prescription drugs or devices.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Returned, Damaged, and Outdated Prescription Drugs or Devices.</text> <paragraph num="(1)"> <text>A wholesale distributor shall quarantine and physically separate prescription drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs or devices until the quarantined and separated drugs or devices are destroyed or returned to their supplier for proper disposal.</text> </paragraph> <paragraph num="(2)"> <text>The wholesale distributor shall identify, mark, quarantine, and physically separate from other prescription drugs or devices those prescription drugs or devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the drugs or devices are either destroyed or returned to their supplier for proper disposal.</text> </paragraph> <paragraph num="(3)"> <text>Prescription Drugs.</text> <paragraph num="(a)"> <text>If the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then the wholesale distributor shall destroy or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity.</text> </paragraph> <paragraph num="(b)"> <text>In determining whether the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, the wholesale distributor shall consider, at a minimum, the:</text> <paragraph num="(i)"> <text>Conditions under which the prescription drug has been held, stored, or shipped before or during its return; and</text> </paragraph> <paragraph num="(ii)"> <text>Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Prescription Devices.</text> <paragraph num="(a)"> <text>If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then the wholesale distributor shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality.</text> </paragraph> <paragraph num="(b)"> <text>In determining whether the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, the wholesale distributor shall consider, among other things, the:</text> <paragraph num="(i)"> <text>Conditions under which the prescription device has been held, stored, or shipped before or during its return; and</text> </paragraph> <paragraph num="(ii)"> <text>Condition of the prescription device and its container, carton, or labeling, as a result of storage or shipping.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs or devices.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Minimum Requirements for Maintenance of Prescription Drug or Device Distribution Records."> <paragraph num="A."> <text>Record Keeping.</text> <paragraph num="(1)"> <text>A wholesale distributor shall establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs or devices.</text> </paragraph> <paragraph num="(2)"> <text>The records required under §A(1) of this regulation shall include the following information:</text> <paragraph num="(a)"> <text>The source of the prescription drugs or devices, including the:</text> <paragraph num="(i)"> <text>Name and principal address of the seller or transferor; and</text> </paragraph> <paragraph num="(ii)"> <text>Address of the location from which the prescription drugs or devices were shipped;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The identity and quantity of the prescription drugs or devices received and distributed or disposed of;</text> </paragraph> <paragraph num="(c)"> <text>The dates of receipt and distribution or other disposition of the prescription drugs or devices; and</text> </paragraph> <paragraph num="(d)"> <text>The pedigrees, if required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, for prescription drugs that are wholesale distributed outside the normal distribution channel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The wholesale distributor shall make available inventories and records for inspection and copying by authorized federal, State, or local law enforcement agency officials for a period of 3 years after their date of creation.</text> </paragraph> <paragraph num="(4)"> <text>The wholesale distributor shall keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either:</text> <paragraph num="(a)"> <text>At the inspection site; or</text> </paragraph> <paragraph num="(b)"> <text>So as to be immediately retrievable by computer or other electronic means.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, the wholesale distributor shall make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable.</text> </paragraph> <paragraph num="(6)"> <text>Facilities shall establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA.</text> </paragraph> <paragraph num="(7)"> <text>Wholesale distributors shall maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to the Board, the FDA, and, where applicable, to the DEA.</text> </paragraph> <paragraph num="(8)"> <text>Wholesale distributors shall consider the following factors when determining if there has been a significant inventory loss:</text> <paragraph num="(a)"> <text>The schedule of the missing items;</text> </paragraph> <paragraph num="(b)"> <text>The abuse or misuse potential of the missing items;</text> </paragraph> <paragraph num="(c)"> <text>The abuse or misuse potential in the wholesale distributor's area of the missing substance;</text> </paragraph> <paragraph num="(d)"> <text>The quantity missing in relation to the total quantity purchased (one tablet vs. one bottle or container);</text> </paragraph> <paragraph num="(e)"> <text>Whether this is the first time a potentially significant inventory loss has occurred;</text> </paragraph> <paragraph num="(f)"> <text>Whether this loss was reported to local law enforcement authorities; and</text> </paragraph> <paragraph num="(g)"> <text>Whether there is a significant resale value of the missing items.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Written Policies and Procedures.</text> <paragraph num="(1)"> <text>A wholesale distributor shall establish, maintain, and adhere to written policies and procedures which shall be followed for:</text> <paragraph num="(a)"> <text>The receipt, security, storage, inventory, and distribution of prescription drugs or devices;</text> </paragraph> <paragraph num="(b)"> <text>Identifying, recording, and reporting losses or thefts; and</text> </paragraph> <paragraph num="(c)"> <text>Correcting errors and inaccuracies in inventories.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A wholesale distributor shall include in the written policies and procedures the following:</text> <paragraph num="(a)"> <text>A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first;</text> </paragraph> <paragraph num="(b)"> <text>Procedures to be followed for adequate handling of a recall and withdrawal of a prescription drug or device due to:</text> <paragraph num="(i)"> <text>An action initiated at the request of the United States Food and Drug Administration or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control;</text> </paragraph> <paragraph num="(ii)"> <text>A voluntary action by the manufacturer to remove a defective or potentially defective drug or device from the market; and</text> </paragraph> <paragraph num="(iii)"> <text>An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A procedure to ensure that the wholesale distributor is prepared for, protected against, and is able to handle a crisis that affects security or operation of a facility if any of the following situations occurs:</text> <paragraph num="(i)"> <text>Strike;</text> </paragraph> <paragraph num="(ii)"> <text>Fire;</text> </paragraph> <paragraph num="(iii)"> <text>Flood;</text> </paragraph> <paragraph num="(iv)"> <text>Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>Terrorist activities;</text> </paragraph> <paragraph num="(vi)"> <text>Other natural disaster; or</text> </paragraph> <paragraph num="(vii)"> <text>Other situations of local, State, or national emergency;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A procedure to ensure that an outdated prescription drug or device is segregated from other drugs or devices and either returned to the manufacturer or destroyed;</text> </paragraph> <paragraph num="(e)"> <text>A procedure for the disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of 3 years, and the appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and</text> </paragraph> <paragraph num="(f)"> <text>A procedure for identifying, segregating, investigating, and reporting prescription drug inventory discrepancies involving counterfeit, suspect of being counterfeit, contraband, or suspect of being contraband, in the inventory and reporting of such discrepancies within 5 business days to the Board and appropriate federal or State agency upon discovery of such discrepancies.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If deviation is appropriate, a wholesale distributor may temporarily deviate from the requirement in §B(2)(a) of this regulation that the oldest approved and unexpired stock be distributed first.</text> </paragraph> <paragraph num="(4)"> <text>The wholesale distributor shall maintain documentation of the disposition of outdated prescription drugs or devices for 2 years after the disposition of the outdated prescription drugs or devices pursuant to procedures under §B(2)(d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Responsible Individuals. A wholesale distributor shall establish and maintain a list of officers, directors, managers, the designated representative, and others in charge of wholesale distribution, storage, and handling, including:</text> <paragraph num="(1)"> <text>A description of their duties; and</text> </paragraph> <paragraph num="(2)"> <text>A summary of their qualifications.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Compliance with Federal, State, and Local Law. A wholesale distributor shall:</text> <paragraph num="(1)"> <text>Operate in compliance with applicable federal, State, and local laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Permit at reasonable times and in a reasonable manner, the Board, the State Division of Drug Control, and any other authorized federal, State, and local law enforcement officials showing proper identification to:</text> <paragraph num="(a)"> <text>Enter and inspect the distributor's premises and delivery vehicles; and</text> </paragraph> <paragraph num="(b)"> <text>Audit and copy the distributor's records and written operating procedures; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If dealing in controlled substances:</text> <paragraph num="(a)"> <text>Register with the:</text> <paragraph num="(i)"> <text>Maryland Division of Drug Control; and</text> </paragraph> <paragraph num="(ii)"> <text>United States Drug Enforcement Administration; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Comply with all applicable federal, State, and local regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Salvaging and Reprocessing.</text> <paragraph num="(1)"> <text>A wholesale distributor is subject to the provisions of applicable federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including 21 CFR Parts 207, 210, and 211, as amended.</text> </paragraph> <paragraph num="(2)"> <text>A wholesale distributor is subject to the provisions of any applicable federal, State, or local laws or regulations that relate to prescription device product salvaging or reprocessing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Due Diligence."> <text>Wholesale distributors having transactions with persons not licensed by the Board or not certified by a third party recognized by the Board shall have in place policies and procedures to perform due diligence on transactions that take place that include:</text> <paragraph num="A."> <text>Verification of alternate licensure;</text> </paragraph> <paragraph num="B."> <text>Verification of identity; and</text> </paragraph> <paragraph num="C."> <text>Verification of recent inspections by a state or third party entity recognized by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reinstatement."> <paragraph num="A."> <text>The wholesale distributor permit shall expire on the last day of its term.</text> </paragraph> <paragraph num="B."> <text>The Board may not reinstate the wholesale distributor permit unless the applicant pays a reinstatement fee set by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Required Information and Procedures for Ceasing to Operate."> <paragraph num="A."> <text>If a wholesale distributor is located in another state, a wholesale distributor anticipating ceasing to operate in Maryland shall return the permit to the Board within 10 days of ceasing to operate in Maryland.</text> </paragraph> <paragraph num="B."> <text>Procedures for Wholesale Distributors Located in this State for Ceasing to Operate.</text> <paragraph num="(1)"> <text>Notification.</text> <paragraph num="(a)"> <text>At least 30 days before a wholesale distributor’s anticipated date of ceasing to operate, the wholesale distributor shall notify the Board in writing, by certified mail, return receipt requested, or hand delivered to the Board’s office, of the day on which the wholesale distributor will cease to operate.</text> </paragraph> <paragraph num="(b)"> <text>A wholesale distributor shall:</text> <paragraph num="(i)"> <text>Notify drug and device suppliers that supply prescription drugs and devices to the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate;</text> </paragraph> <paragraph num="(ii)"> <text>Notify manufacturers, wholesale distributors, licensed pharmacies and authorized prescribers that receive prescription drugs and devices from the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate; and</text> </paragraph> <paragraph num="(iii)"> <text>Comply with applicable federal regulations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The wholesale distributor shall submit to and pass a closing inspection conducted by the Board.</text> </paragraph> <paragraph num="(3)"> <text>With the exception of controlled dangerous substances, the wholesale distributor shall dispose of prescription drugs or devices in stock by one or more of the following means:</text> <paragraph num="(a)"> <text>Returning the prescription drugs or devices to a distributor or manufacturer;</text> </paragraph> <paragraph num="(b)"> <text>Transferring the prescription drugs or devices to another wholesale distributor, licensed pharmacy, authorized prescriber, or other person or entity approved by the Board; or</text> </paragraph> <paragraph num="(c)"> <text>Destroying in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Disposition of Controlled Dangerous Substances. The wholesale distributor shall comply with the procedures set forth in this regulation in addition to those set forth in COMAR 10.19.03.10 governing the transfer, return or disposal of controlled dangerous substances.</text> </paragraph> <paragraph num="(5)"> <text>At the closing inspection, the wholesale distributor shall provide to the Board the following:</text> <paragraph num="(a)"> <text>The exact date on which the wholesale distributor ceased to operate;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the inventory of prescription drugs or devices disposed of, transferred, or returned.</text> </paragraph> <paragraph num="(c)"> <text>The names, addresses, telephone numbers, and Drug Enforcement Administration registration numbers, if applicable, of the persons or business entities to whom prescription drugs or devices in stock were returned or transferred under this regulation;</text> </paragraph> <paragraph num="(d)"> <text>The wholesale distributor permit;</text> </paragraph> <paragraph num="(e)"> <text>If prescription drugs or devices are destroyed pursuant to this regulation, a letter, signed under oath by the wholesale distributor, stating the:</text> <paragraph num="(i)"> <text>Date, place and manner in which the prescription drugs or devices were destroyed;</text> </paragraph> <paragraph num="(ii)"> <text>Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs or devices; and</text> </paragraph> <paragraph num="(iii)"> <text>Name, dosage unit, and quantity of each type of prescription drug or device destroyed; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>If any pedigrees or other documents are transferred, a letter, signed under oath by the wholesale distributor, stating:</text> <paragraph num="(i)"> <text>The date, time, place to which and manner in which the pedigrees or other documents were transferred; and</text> </paragraph> <paragraph num="(ii)"> <text>The names, addresses, and telephone numbers of the persons responsible for transferring the pedigrees or other documents.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>At the closing inspection, the wholesale distributor shall provide to the Division of Drug Control the following pertaining to controlled dangerous substances:</text> <paragraph num="(a)"> <text>The exact date on which the wholesale distributor ceased to operate;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the closing inventory of controlled dangerous substances required by the Drug Enforcement Administration.</text> </paragraph> <paragraph num="(c)"> <text>The names, addresses, telephone numbers, Drug Enforcement Administration registration numbers, Division of Drug Control registration numbers, and Board permit numbers, if applicable, of the persons or business entities to whom controlled dangerous substances in stock were returned or transferred under this regulation; and</text> </paragraph> <paragraph num="(d)"> <text>The Maryland Department of Health Controlled Dangerous Substance Registration for cancellation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Relocation."> <paragraph num="A."> <text>At least 30 days before relocation, a permit holder shall submit an application to the Board.</text> </paragraph> <paragraph num="B."> <text>If relocation is due to a catastrophic event or State of Emergency, the relocation applicant shall:</text> <paragraph num="(1)"> <text>Notify the Board within 48 hours; and</text> </paragraph> <paragraph num="(2)"> <text>Submit an application to the Board within 30 days.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A relocation applicant:</text> <paragraph num="(1)"> <text>If the applicant holds products, shall comply with Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall submit a surety bond or other equivalent means of security acceptable to the State specific to the permit holder’s relocation, in accordance with Regulation .03 if this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Shall indicate on the application changes in product or personnel from the original application to the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A new or different designated representative or immediate supervisor of a designated representative functioning at the relocated facility shall be required to undergo a criminal history records check as set forth in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="E."> <text>As part of the application process, a relocation applicant located in this State shall submit to and pass an opening inspection conducted by the Board, which shall include:</text> <paragraph num="(1)"> <text>Documentation of the permit holder’s notification to suppliers of prescription drugs and devices of the permit holder’s relocation; and</text> </paragraph> <paragraph num="(2)"> <text>Documentation from the permit holder evidencing the appropriate transfer, return, or disposal of any prescription drugs or devices not transferred to the facility’s relocation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A relocation applicant located in another state shall provide to the Board:</text> <paragraph num="(1)"> <text>Evidence of approval of the permit holder’s relocation from the accreditation organization that accredited the permit holder’s original location; or</text> </paragraph> <paragraph num="(2)"> <text>If the relocation applicant is not required to be accredited by an accreditation organization in accordance with Maryland law, inspection reports from the state in which the relocation applicant is located pertaining to the permit holder’s relocation.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205, 12-601, and 12-6C-01 — 12-6C-13, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 31, 1992 (19:17 Md. R. 1607)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 repealed and new Regulations .01 — .09 adopted effective March 28, 2005 (32:6 Md. R. 636)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 repealed and new Regulations .01 — .08 adopted effective April 7, 2008 (35:7 Md. R. 748)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective July 1, 2014 (41:10 Md. R. 561)</annotation> </annotations> </chapter> <chapter num="23" heading="Pharmaceutical Services to Patients in Comprehensive Care Facilities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to pharmacies and licensed pharmacists serving comprehensive care facilities as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for these facilities.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Chart order” means a lawful order entered on the chart or a medical record of a patient of a comprehensive care facility by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device.</text> </paragraph> <paragraph num="(2)"> <text>Comprehensive Care Facility.</text> <paragraph num="(a)"> <text>“Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service and nursing service rendered by or under the supervision of a registered nurse.</text> </paragraph> <paragraph num="(b)"> <text>“Comprehensive care facility” does not mean an establishment which provides only:</text> <paragraph num="(i)"> <text>Acute care; or</text> </paragraph> <paragraph num="(ii)"> <text>Assisted living care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Emergency drug kit” means a container or electronic storage system containing medications which:</text> <paragraph num="(a)"> <text>May be required for the emergency need of a patient; and</text> </paragraph> <paragraph num="(b)"> <text>Are not available from an authorized source in a timely manner.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Interim box” means a container or an electronic system holding minimal quantities of medications:</text> <paragraph num="(a)"> <text>Agreed upon by the comprehensive care facility’s pharmaceutical services committee, as defined in COMAR 10.07.02.15; and</text> </paragraph> <paragraph num="(b)"> <text>Intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Licensed pharmacist” means a pharmacist who is licensed by the Board to practice pharmacy.</text> </paragraph> <paragraph num="(6)"> <text>“Packaging” means the process by which a medication is:</text> <paragraph num="(a)"> <text>Removed from a:</text> <paragraph num="(i)"> <text>Non-patient specific manufacturer’s original container; or</text> </paragraph> <paragraph num="(ii)"> <text>Patient specific container directly received from another pharmacy licensed in Maryland or operated by the government of the United States provided that the manufacturer’s name is present on the container; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Placed into a new container by a licensed pharmacist or registered pharmacy technician under the supervision of a pharmacist.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Pharmaceutical services” means the care within practice standards, laws, regulations, and guidelines which is afforded by a licensed pharmacist to the patients of a comprehensive care facility.</text> </paragraph> <paragraph num="(8)"> <text>“Pharmacy” means a holder of a pharmacy permit issued by the Board, located either on the premises of or outside the comprehensive care facility and which provides pharmaceutical services to patients in a comprehensive care facility.</text> </paragraph> <paragraph num="(9)"> <text>“Pharmacy area” means that portion of the licensed pharmacy where medication and other products requiring a prescription by federal or State law are stored and where the prescriptions are compounded or prepared.</text> </paragraph> <paragraph num="(10)"> <text>“Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text> </paragraph> <paragraph num="(11)"> <text>“Verbal order” means a directive that is orally communicated to a licensed pharmacist to accept a prescription order by a person who is authorized to communicate a prescription.</text> </paragraph> <paragraph num="(12)"> <text>“Written order” means a directive that is directly written by an authorized prescriber or a transcription of an order from an authorized prescriber by a person authorized to transcribe an order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Policies and Procedures."> <text>The permit holder shall establish and operate under a policies and procedures manual which:</text> <paragraph num="A."> <text>Complies with this chapter;</text> </paragraph> <paragraph num="B."> <text>Defines the scope and method of pharmacy services provided to the patients of the comprehensive care facility;</text> </paragraph> <paragraph num="C."> <text>Determines when personnel may have access to the pharmacy area;</text> </paragraph> <paragraph num="D."> <text>Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;</text> </paragraph> <paragraph num="E."> <text>Includes:</text> <paragraph num="(1)"> <text>Labeling requirements and distribution methods for medication provided in a single container, slot, blister package, or other method of delivering an entire single dosing unit; and</text> </paragraph> <paragraph num="(2)"> <text>The conditions in which an interim box may be replenished or prepared, delivered, and stored by the comprehensive care facility in accordance with Regulation .09 of this chapter;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Is provided to:</text> <paragraph num="(1)"> <text>The personnel of the pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>The comprehensive care facility; and</text> </paragraph> <paragraph num="(3)"> <text>Upon request, an agent of the Board; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Is in a form that is:</text> <paragraph num="(1)"> <text>Written or electronic; and</text> </paragraph> <paragraph num="(2)"> <text>Readily retrievable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Personnel."> <paragraph num="A."> <text>Director of Pharmacy. The permit holder shall appoint a licensed pharmacist as director of pharmacy who is:</text> <paragraph num="(1)"> <text>Licensed to engage in the practice of pharmacy in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Knowledgeable in, and thoroughly familiar with, the specialized functions of comprehensive care facility pharmaceutical services;</text> </paragraph> <paragraph num="(3)"> <text>Responsible for and in full and actual charge of the pharmacy and its personnel;</text> </paragraph> <paragraph num="(4)"> <text>Responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title;</text> </paragraph> <paragraph num="(5)"> <text>Responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary;</text> </paragraph> <paragraph num="(6)"> <text>On site full time; and</text> </paragraph> <paragraph num="(7)"> <text>Responsible for only one comprehensive care pharmacy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff.</text> <paragraph num="(1)"> <text>The permit holder:</text> <paragraph num="(a)"> <text>May employ registered pharmacy technicians as required to provide pharmaceutical services to the patients of the comprehensive care facilities; and</text> </paragraph> <paragraph num="(b)"> <text>Shall provide policies and procedures that specify the duties that may be performed by registered pharmacy technicians under the supervision of a licensed pharmacist and the duties that may be performed only by a licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The permit holder may employ unlicensed personnel to provide operational support as defined in COMAR 10.34.21.02B.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physical Requirements."> <paragraph num="A."> <text>Storage. The director of pharmacy or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to:</text> <paragraph num="(1)"> <text>Sanitation;</text> </paragraph> <paragraph num="(2)"> <text>Temperature;</text> </paragraph> <paragraph num="(3)"> <text>Light;</text> </paragraph> <paragraph num="(4)"> <text>Ventilation;</text> </paragraph> <paragraph num="(5)"> <text>Moisture control;</text> </paragraph> <paragraph num="(6)"> <text>Segregation; and</text> </paragraph> <paragraph num="(7)"> <text>Security.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Equipment and Materials.</text> <paragraph num="(1)"> <text>The director of pharmacy or designee shall ensure that the pharmacy contains appropriate:</text> <paragraph num="(a)"> <text>Equipment;</text> </paragraph> <paragraph num="(b)"> <text>Supplies; and</text> </paragraph> <paragraph num="(c)"> <text>Physical facilities for proper compounding, preparation, and dispensing of medications as outlined in COMAR 10.34.19.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The director of pharmacy or designee shall ensure that the pharmacy contains appropriate reference materials to enable personnel to prepare and dispense medications properly as outlined in COMAR 10.34.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Security.</text> <paragraph num="(1)"> <text>The director of pharmacy or designee shall ensure that no individual enters the pharmacy area unless a licensed pharmacist is on duty.</text> </paragraph> <paragraph num="(2)"> <text>The permit holder and the director of pharmacy or designee shall ensure compliance with COMAR 10.34.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Medication and Device Distribution and Pharmaceutical Services."> <paragraph num="A."> <text>The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.</text> </paragraph> <paragraph num="B."> <text>The director of pharmacy or designee shall work in cooperation with the professional staff of the comprehensive care facility in:</text> <paragraph num="(1)"> <text>Meeting the responsibilities set forth in §C of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Ordering, storing, and accounting for pharmaceutical materials.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The director of pharmacy or designee shall be responsible for, at a minimum:</text> <paragraph num="(1)"> <text>The preparation of medications compounded in the pharmacy as applicable;</text> </paragraph> <paragraph num="(2)"> <text>The proper preparation, storage, and distribution of compounded sterile preparations according to COMAR 10.34.19 to the extent that the functions are performed at the pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>The packaging and labeling of medications;</text> </paragraph> <paragraph num="(4)"> <text>Records of transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for pharmaceuticals, including patient medication profiles;</text> </paragraph> <paragraph num="(5)"> <text>Participation in those aspects of the comprehensive care facility's quality assurance improvement program which relate to pharmaceutical care and effectiveness; and</text> </paragraph> <paragraph num="(6)"> <text>Implementation of the policies and decisions of the appropriate committee or committees of the comprehensive care facility related to these regulations and to other regulations of the facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Medication Packaging."> <paragraph num="A."> <text>A licensed pharmacist shall verify the:</text> <paragraph num="(1)"> <text>Selection of medication to be packaged; and</text> </paragraph> <paragraph num="(2)"> <text>Completed packaging of medication performed by registered pharmacy technicians for the following:</text> <paragraph num="(a)"> <text>Accuracy;</text> </paragraph> <paragraph num="(b)"> <text>Completeness;</text> </paragraph> <paragraph num="(c)"> <text>Appropriateness; and</text> </paragraph> <paragraph num="(d)"> <text>Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The licensed pharmacist shall ensure that labeling of the medication container includes the:</text> <paragraph num="(1)"> <text>Brand or generic name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>Strength of the medication, if appropriate;</text> </paragraph> <paragraph num="(3)"> <text>Name of the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>Expiration date of the medication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:</text> <paragraph num="(1)"> <text>12 months from the date of packaging;</text> </paragraph> <paragraph num="(2)"> <text>The manufacturer's or distributor's listed expiration date; or</text> </paragraph> <paragraph num="(3)"> <text>The maximum time period allowed for the specific packaging used for the medication.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the:</text> <paragraph num="(1)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(2)"> <text>Strength;</text> </paragraph> <paragraph num="(3)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(4)"> <text>Lot number assigned by the pharmacy;</text> </paragraph> <paragraph num="(5)"> <text>Lot number assigned by the distributor or manufacturer;</text> </paragraph> <paragraph num="(6)"> <text>Quantity packaged;</text> </paragraph> <paragraph num="(7)"> <text>Expiration date as defined in §C of this regulation;</text> </paragraph> <paragraph num="(8)"> <text>Manufacturer's expiration date;</text> </paragraph> <paragraph num="(9)"> <text>Date of packaging;</text> </paragraph> <paragraph num="(10)"> <text>Name of pharmacy technician packaging; and</text> </paragraph> <paragraph num="(11)"> <text>Name and initials of verifying licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Packaged from Another Pharmacy. The licensed pharmacist may package patient specific medication received from another pharmacy licensed in Maryland or operated by the government of the United States provided that:</text> <paragraph num="(1)"> <text>The licensed pharmacist determines that the medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the time it was dispensed by the original pharmacy and received by the packaging pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>The licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging;</text> </paragraph> <paragraph num="(3)"> <text>The manufacturer’s name is present on the container received from the other pharmacy; and</text> </paragraph> <paragraph num="(4)"> <text>The licensed pharmacist maintains a master log that includes the following information:</text> <paragraph num="(a)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(b)"> <text>Lot number assigned by the packaging pharmacy;</text> </paragraph> <paragraph num="(c)"> <text>Strength;</text> </paragraph> <paragraph num="(d)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(e)"> <text>Name, address, and telephone number of the original dispensing pharmacy;</text> </paragraph> <paragraph num="(f)"> <text>Prescription number for the original dispensing pharmacy;</text> </paragraph> <paragraph num="(g)"> <text>Quantity packaged;</text> </paragraph> <paragraph num="(h)"> <text>Expiration date as assigned by the original dispensing pharmacy;</text> </paragraph> <paragraph num="(i)"> <text>Date of packaging;</text> </paragraph> <paragraph num="(j)"> <text>Name of pharmacy technician packaging;</text> </paragraph> <paragraph num="(k)"> <text>Name and initials of verifying licensed pharmacist; and</text> </paragraph> <paragraph num="(l)"> <text>Name of the patient.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Labeling of Patient Medications."> <paragraph num="A."> <text>The director of pharmacy or designee shall ensure that medications dispensed by the pharmacy and intended for use within the comprehensive care facility are dispensed in appropriate containers and are labeled with the:</text> <paragraph num="(1)"> <text>Name and address of the pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>Date of dispensing;</text> </paragraph> <paragraph num="(3)"> <text>Prescription number assigned by the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>Name of the patient;</text> </paragraph> <paragraph num="(5)"> <text>Name, quantity, and strength of the drug;</text> </paragraph> <paragraph num="(6)"> <text>Name of the prescriber;</text> </paragraph> <paragraph num="(7)"> <text>Expiration date of the drug;</text> </paragraph> <paragraph num="(8)"> <text>Required precautionary information regarding controlled substances; and</text> </paragraph> <paragraph num="(9)"> <text>Further cautionary information as may be required or desirable for proper use of the medication.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The director of pharmacy or designee shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package is labeled with at least the following:</text> <paragraph num="(1)"> <text>Drug name;</text> </paragraph> <paragraph num="(2)"> <text>Drug strength;</text> </paragraph> <paragraph num="(3)"> <text>Name of manufacturer;</text> </paragraph> <paragraph num="(4)"> <text>Name of the patient;</text> </paragraph> <paragraph num="(5)"> <text>Lot number; and</text> </paragraph> <paragraph num="(6)"> <text>Expiration date.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.</text> </paragraph> <paragraph num="D."> <text>The director of pharmacy or designee shall work in cooperation with the other professional staff of the comprehensive care facility in meeting the responsibilities set forth in §B of the regulation and in ordering, storing, and accounting for pharmaceutical materials.</text> </paragraph> <paragraph num="E."> <text>Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Drug Control and Accountability."> <paragraph num="A."> <text>The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued.</text> </paragraph> <paragraph num="B."> <text>Medications may be accepted for return if:</text> <paragraph num="(1)"> <text>The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device;</text> </paragraph> <paragraph num="(2)"> <text>The licensed pharmacist determines that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and</text> </paragraph> <paragraph num="(3)"> <text>The permit holder otherwise complies with COMAR 10.34.10.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Discontinued Medications — Controlled Dangerous Substances.</text> <paragraph num="(1)"> <text>Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A compounded sterile preparation may not be returned to the inventory of a pharmacy.</text> </paragraph> <paragraph num="E."> <text>Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.</text> </paragraph> <paragraph num="F."> <text>Emergency Drug Kit.</text> <paragraph num="(1)"> <text>The director of pharmacy or designee shall ensure that the emergency drug kit is secured with a tamper-evident seal or electronic security system which will indicate the opening of the kit.</text> </paragraph> <paragraph num="(2)"> <text>Labeling. The director of pharmacy or designee shall ensure that the emergency drug kit meets the following specifications:</text> <paragraph num="(a)"> <text>The exterior of the emergency drug kit is labeled to indicate clearly and unmistakably that it is an emergency drug kit and that it is for use in emergencies only;</text> </paragraph> <paragraph num="(b)"> <text>The exterior of the emergency drug kit is labeled to indicate the:</text> <paragraph num="(i)"> <text>Names of the drugs contained in the emergency drug kit;</text> </paragraph> <paragraph num="(ii)"> <text>Strengths of the drugs contained in the emergency drug kit;</text> </paragraph> <paragraph num="(iii)"> <text>List of contents with expiration dates, with the date of the first item to expire in bold print; and</text> </paragraph> <paragraph num="(iv)"> <text>The quantity of each drug contained in the emergency drug kit; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Medications contained in the emergency drug kit are labeled with the:</text> <paragraph num="(i)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(ii)"> <text>Strength of the drug;</text> </paragraph> <paragraph num="(iii)"> <text>Expiration date of the drug;</text> </paragraph> <paragraph num="(iv)"> <text>Lot number of the drug; and</text> </paragraph> <paragraph num="(v)"> <text>Other information required by the medical staff.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Replacement of Medications.</text> <paragraph num="(a)"> <text>A licensed pharmacist or licensed pharmacist's designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within 72 hours of notification of use or expiration.</text> </paragraph> <paragraph num="(b)"> <text>A licensed pharmacist shall perform the final check on the contents of the emergency drug kit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Interim Box.</text> <paragraph num="(1)"> <text>An interim box may be provided by the pharmacy and kept at the comprehensive care facility if comprehensive care facility policies and procedures address an interim box and the pharmacy complies with these policies and procedures.</text> </paragraph> <paragraph num="(2)"> <text>A licensed pharmacist shall perform the final check on the contents of the interim box.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Prescriber Orders.</text> <paragraph num="(1)"> <text>A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber.</text> </paragraph> <paragraph num="(2)"> <text>A chart order shall be considered a prescription drug order provided that the prescription drug order contains:</text> <paragraph num="(a)"> <text>The full name of the patient;</text> </paragraph> <paragraph num="(b)"> <text>The date of issuance;</text> </paragraph> <paragraph num="(c)"> <text>The name, strength, and dosage form of the drug prescribed;</text> </paragraph> <paragraph num="(d)"> <text>The name, type, and specifications of any device;</text> </paragraph> <paragraph num="(e)"> <text>The directions for use;</text> </paragraph> <paragraph num="(f)"> <text>If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber);</text> </paragraph> <paragraph num="(g)"> <text>If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and</text> </paragraph> <paragraph num="(h)"> <text>If verbal, the name of the prescriber and the prescriber’s agent, if applicable.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order.</text> </paragraph> <paragraph num="(4)"> <text>The licensed pharmacist shall document immediately a verbal order in writing.</text> </paragraph> <paragraph num="(5)"> <text>A licensed pharmacist may receive a verbal order:</text> <paragraph num="(a)"> <text>By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or</text> </paragraph> <paragraph num="(b)"> <text>By a voice messaging system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Controlled Dangerous Substances.</text> <paragraph num="(1)"> <text>Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in Health-General Article, Title 27, Annotated Code of Maryland, and COMAR 10.19.03.</text> </paragraph> <paragraph num="(2)"> <text>Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Drug Recalls. The director of pharmacy or designee shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are returned to the pharmacy, sequestered, and handled as appropriate to the level of the recall.</text> </paragraph> <paragraph num="K."> <text>Adverse Drug Reactions.</text> <paragraph num="(1)"> <text>The director of pharmacy or designee shall participate on the appropriate committee of the comprehensive care facility to establish procedures to report and record adverse drug reactions.</text> </paragraph> <paragraph num="(2)"> <text>The director of pharmacy or designee shall ensure the procedures established include, at a minimum:</text> <paragraph num="(a)"> <text>The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the committee of the comprehensive care facility; and</text> </paragraph> <paragraph num="(b)"> <text>The recording in writing of an adverse reaction on the patient’s chart at the time it is reported.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>Records and Reports. The director of pharmacy or designee shall maintain records and reports as may be required by law, this chapter, and the policies of the comprehensive care facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Management."> <text>The director of pharmacy or designee, in cooperation with the pharmaceutical services committee of the comprehensive care facility, shall be responsible for developing procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205, 12-301, 12-401, 12-403, 12-501, 12-503, 12-504, 12-505, 12-506, and 12-6B-01, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 7, 1996 (23:20 Md. R. 1424)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 1, 2011 (38:11 Md. R. 671)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective September 16, 2013 (40:18 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D, E amended effective April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective April 2, 2012 (39:6 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09G amended effective September 16, 2013 (40:18 Md. R. 1479)</annotation> </annotations> </chapter> <chapter num="24" heading="Record of Drug Inventory Acquisition"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to establish the minimum requirements for drug acquisition records to be maintained by pharmacy permit holders.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This chapter applies to all pharmacy permit holders in this State.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to the acquisition of all prescription medication drug inventories.</text> </paragraph> <paragraph num="C."> <text>This chapter applies to a pharmacy's acquisition of drug inventory from all sources including, but not limited to, pharmacies, distributors, and manufacturers, and through all means including, but not limited to, purchases, barter or exchange, free goods, rebates, and replacement products.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Minimum Requirements for Maintenance of Drug Acquisition Records."> <paragraph num="A."> <text>A pharmacy permit holder shall maintain records of all drug inventory acquisitions.</text> </paragraph> <paragraph num="B."> <text>The records maintained shall include:</text> <paragraph num="(1)"> <text>The name and principal address of the source of the drugs;</text> </paragraph> <paragraph num="(2)"> <text>The identity and quantity of the drugs received; and</text> </paragraph> <paragraph num="(3)"> <text>The date the drugs were received.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The acquisition records shall be kept for a period of 2 years from the date the inventory was received.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Violation and Inspection."> <paragraph num="A."> <text>A pharmacy permit holder shall make the drug inventory acquisition records required under this chapter available for inspection upon request by any federal, state, or local law enforcement agent, or any other duly authorized agent of the Board of Pharmacy or the Division of Drug Control, within 72 hours of the request.</text> </paragraph> <paragraph num="B."> <text>A pharmacy permit holder shall produce and maintain the records required under this chapter for drug acquisitions for all acquisitions except those replaced within 7 days.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 17, 2001 (28:18 Md. R. 1621)</annotation> </annotations> </chapter> <chapter num="25" heading="Delivery of Prescriptions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the manner in which a Maryland licensed pharmacy delivers filled prescriptions for individual patients by United States Postal Service, common carrier, or delivery service to an address within the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Delivery” means to send a prescription medication from a pharmacy by the United States Postal Service, common carrier, or delivery system to an address within the State.</text> </paragraph> <paragraph num="(2)"> <text>Depot.</text> <paragraph num="(a)"> <text>“Depot” means a location where filled prescriptions are stored before delivery to the intended patient or the intended patient's authorized agent.</text> </paragraph> <paragraph num="(b)"> <text>“Depot” does not include:</text> <paragraph num="(i)"> <text>A licensed health care facility;</text> </paragraph> <paragraph num="(ii)"> <text>A prescriber's office;</text> </paragraph> <paragraph num="(iii)"> <text>The prescription area of a pharmacy as defined by COMAR 10.34.05.01;</text> </paragraph> <paragraph num="(iv)"> <text>The United States Postal Service or common carrier's warehouse; or</text> </paragraph> <paragraph num="(v)"> <text>A multiple family residence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Patient” means the individual or companion animal for whom a prescription is written and to whom a prescription medication will be administered.</text> </paragraph> <paragraph num="(4)"> <text>“Patient profile” means a record of dispensing activity maintained by a pharmacist for a specific patient.</text> </paragraph> <paragraph num="(5)"> <text>“Residence” means the street address at which a patient resides.</text> </paragraph> <paragraph num="(6)"> <text>“Storage” means the maintenance of a supply of medication before receipt of the medication by the patient or an agent authorized by the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Packaging and Delivery of Prescription Medication."> <paragraph num="A."> <text>Packaging. Prescription medications delivered under this chapter to individuals in the State shall be:</text> <paragraph num="(1)"> <text>Enclosed in a container that reveals to the patient any tampering of the container that occurred during delivery or storage;</text> </paragraph> <paragraph num="(2)"> <text>Packaged in a shipping container in a manner that does not indicate that the contents are medications;</text> </paragraph> <paragraph num="(3)"> <text>Packaged in a manner that indicates:</text> <paragraph num="(a)"> <text>The name and address of the patient or authorized agent; and</text> </paragraph> <paragraph num="(b)"> <text>Any special storage conditions or requirements; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Packaged to contain:</text> <paragraph num="(a)"> <text>Written information regarding the prescription drug or device which is considered significant in the professional judgment of the pharmacist;</text> </paragraph> <paragraph num="(b)"> <text>A local or toll-free telephone number for the pharmacy; and</text> </paragraph> <paragraph num="(c)"> <text>Notification to the patient if the appearance of the patient’s medication has changed from the patient’s last refill.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Delivery.</text> <paragraph num="(1)"> <text>Location.</text> <paragraph num="(a)"> <text>A prescription medication may be delivered to the patient for whom the prescription is prescribed, wherever the patient is located.</text> </paragraph> <paragraph num="(b)"> <text>Instead of delivering medication directly to the patient under §B(1)(a) of this regulation, medication may be delivered to:</text> <paragraph num="(i)"> <text>An agent authorized by the patient; or</text> </paragraph> <paragraph num="(ii)"> <text>The residence of the patient, regardless of whether the patient is present at the residence at the time of delivery.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The pharmacy permit holder shall:</text> <paragraph num="(a)"> <text>Enclose information to inform the patient if the patient’s prescription is a temperature sensitive medication that is at risk for damage due to extreme hot or cold temperatures or moisture:</text> <paragraph num="(i)"> <text>During shipment; or</text> </paragraph> <paragraph num="(ii)"> <text>After delivery to the patient’s mailbox or other designated location; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Inform the patient within 24 hours of being notified of the delay if the scheduled delivery of the patient’s prescription will be interrupted or late.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Depots."> <text>A pharmacy may not knowingly deliver prescription medications to a depot, or establish or cooperate in the establishment of a depot.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Record Keeping."> <paragraph num="A."> <text>If a patient authorizes delivery of prescription medication to an agent at a location other than the pharmacy, or the patient's residence, the pharmacist shall document the authorization:</text> <paragraph num="(1)"> <text>On the prescription;</text> </paragraph> <paragraph num="(2)"> <text>In the patient profile; or</text> </paragraph> <paragraph num="(3)"> <text>In another record maintained in the pharmacy and established for this purpose.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If prescription medication is sent to an agent authorized by the patient at a location other than the patient's residence, or the place of business of the patient's authorized prescriber, the pharmacy shall maintain a record of the:</text> <paragraph num="(1)"> <text>Identity of the agent to whom the medication is sent;</text> </paragraph> <paragraph num="(2)"> <text>Location where the medication is sent;</text> </paragraph> <paragraph num="(3)"> <text>Date and time the medication is sent; and</text> </paragraph> <paragraph num="(4)"> <text>Prescription number or description of the medication sent.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 10, 2001 (28:24 Md. R. 2128)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 1, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 1, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective March 1, 2012 (39:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective March 1, 2012 (39:1 Md. R. 17)</annotation> </annotations> </chapter> <chapter num="26" heading="Patient Safety Improvement"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“High-alert medication” means a medication with:</text> <paragraph num="(a)"> <text>A significant potential for involvement in a mediation error due to the medication's name, packaging, appearance, dosing, or other characteristics of the agent; or</text> </paragraph> <paragraph num="(b)"> <text>A high potential for causing serious harm or injury if used incorrectly.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Medication Error.</text> <paragraph num="(a)"> <text>“Medication error” means any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.</text> </paragraph> <paragraph num="(b)"> <text>“Medication error” includes events that may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ongoing Quality Assurance Program.</text> <paragraph num="(a)"> <text>“Ongoing quality assurance program” means a program that systematically and routinely reviews the medication delivery system of a pharmacy for the purpose of minimizing the occurrence of medication errors.</text> </paragraph> <paragraph num="(b)"> <text>“Ongoing quality assurance program” includes:</text> <paragraph num="(i)"> <text>The systematic and routine collection of information regarding the performance of the medication delivery system as it becomes available;</text> </paragraph> <paragraph num="(ii)"> <text>The investigation of medication errors at the time the error is reported or discovered, or within a reasonable amount of time after the medication error is reported or discovered; or</text> </paragraph> <paragraph num="(iii)"> <text>A record, proceeding, file, or other document maintained to comply with Regulations .03 or .04 of this chapter, COMAR 10.34.21.03, COMAR 10.34.28.09, or COMAR 10.34.28.10.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Patient Education."> <paragraph num="A."> <text>The pharmacy permit holder shall establish methods to provide patients with information regarding the patient's role and responsibility in preventing medication errors in a manner that is reasonably likely to convey the information to the patient, and if applicable, the patient's health care agent or surrogate decision maker, under Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and that is in addition to any other patient counseling or information required to be given by other laws and regulations.</text> </paragraph> <paragraph num="B."> <text>The information in §A of this regulation shall be provided to the patient before or at the time the drug or device is presented to the patient.</text> </paragraph> <paragraph num="C."> <text>Exception. If the patient is an inpatient at a health care facility, the information in §A of this regulation shall be:</text> <paragraph num="(1)"> <text>Provided directly to a patient and, if applicable, a patient's health care agent or surrogate decision maker before discharge; or</text> </paragraph> <paragraph num="(2)"> <text>Available in a conspicuous location on the institution's premises where the patient and, if applicable, the patient's health care agent or surrogate decision maker, are reasonably likely to have an opportunity to review the information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The information provided to patients shall include:</text> <paragraph num="(1)"> <text>A patient's rights when receiving a medication or a prescription;</text> </paragraph> <paragraph num="(2)"> <text>The patient's role and responsibility in preventing a medication error;</text> </paragraph> <paragraph num="(3)"> <text>The procedures to follow when reporting a suspected medication error to the pharmacy permit holder, pharmacist, health care facility, or other healthcare provider; and</text> </paragraph> <paragraph num="(4)"> <text>How to report a suspected medication error to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Pharmacy Staff Education."> <text>As part of a pharmacy permit holder's ongoing quality assurance program, the pharmacy permit holder shall:</text> <paragraph num="A."> <text>Ensure that each member of the pharmacy staff involved in the medication delivery system receive at least once a year, education regarding the role and responsibility of pharmacy staff in preventing medication errors; and</text> </paragraph> <paragraph num="B."> <text>Maintain records for a minimum of 2 years:</text> <paragraph num="(1)"> <text>Verifying completion of education referred to in §A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrating the content of the education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Ongoing Quality Assurance Program."> <paragraph num="A."> <text>A pharmacy permit holder shall establish and maintain an ongoing quality assurance program to:</text> <paragraph num="(1)"> <text>Identify, investigate, and promote the prevention of medication errors; and</text> </paragraph> <paragraph num="(2)"> <text>Establish protocols and procedures to minimize the potential for medication errors.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The ongoing quality assurance program shall include the records, proceedings, files, and any other documents of the ongoing quality assurance program, including for each medication error:</text> <paragraph num="(1)"> <text>The date of the error;</text> </paragraph> <paragraph num="(2)"> <text>A brief description of the error;</text> </paragraph> <paragraph num="(3)"> <text>The results of the evaluation by the ongoing quality assurance program's investigation; and</text> </paragraph> <paragraph num="(4)"> <text>Remedial action taken or recommendations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Periodic Review.</text> <paragraph num="(1)"> <text>A pharmacy permit holder shall analyze the records, proceedings, files, and any other documents of the ongoing quality assurance program required under §B of this regulation, including any medication errors relating to automated medication systems or unlicensed personnel, at least every 3 months as part of the periodic review that is required to maintain an ongoing quality assurance program.</text> </paragraph> <paragraph num="(2)"> <text>Each pharmacy permit holder shall conduct an analysis of its medication delivery system at least every 6 months to determine which medications in the prescription area of the pharmacy are high-alert medications, as part of the pharmacy's ongoing quality assurance program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Documentation of Periodic Review. The records, proceedings, files, and any other documents of the ongoing quality assurance program shall include for each:</text> <paragraph num="(1)"> <text>Periodic review required under §C(1) of this regulation:</text> <paragraph num="(a)"> <text>Documentation of the periodic review;</text> </paragraph> <paragraph num="(b)"> <text>A description of the system's weaknesses found during the periodic review; and</text> </paragraph> <paragraph num="(c)"> <text>A description of the actions taken to remedy any weaknesses identified in the medication system; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Analysis of a pharmacy's medication delivery system to identify high-alert medications required under §C(2) of this regulation:</text> <paragraph num="(a)"> <text>A list of high-alert medications present in the prescription area of the pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>The date that a high-alert medication was added to or removed from the list of high-alert medications;</text> </paragraph> <paragraph num="(c)"> <text>Dates that the list was reviewed by the pharmacy permit holder; and</text> </paragraph> <paragraph num="(d)"> <text>Remedial actions taken based on the review of the list of high-alert medications and any medication errors relating to the high-alert medications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Unless otherwise specified in law, the permit holder shall maintain the ongoing quality assurance program records referred to in this regulation for 2 years.</text> </paragraph> <paragraph num="F."> <text>The proceedings, records, and files of an ongoing quality assurance program that meets the requirements of Health Occupations Article, §1-401, Annotated Code of Maryland, and this chapter, are not discoverable and are not admissible in evidence in any civil action, as provided in Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 27, 2003 (30:21 Md. R. 1529)</annotation> </annotations> </chapter> <chapter num="27" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The custodian of records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual that the custodian of records reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prohibit or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §12-205(a)(3);State Government Article, §10-617(h)(3); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 2002 (28:26 Md. R. 2273)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 11, 2003 (30:24 Md. R. 1741)</annotation> </annotations> </chapter> <chapter num="28" heading="Automated Medication Systems"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines the parameters under which a permit holder may allow the use of automated medication systems to facilitate the dispensing and distribution of medication.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Automated medication system” means a centralized, decentralized, or remote robotic or computerized device and that device's components designed to:</text> <paragraph num="(a)"> <text>Distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Prepare medications for final dispensing by a licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Centralized automated medication system” means an automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient.</text> </paragraph> <paragraph num="(3)"> <text>“Decentralized automated medication system” means an automated medication system that is located outside of the pharmacy in a health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.</text> </paragraph> <paragraph num="(4)"> <text>“Distribution” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Annotated Code of Maryland, before the administration of the provided drug or device to a patient and pursuant to an order issued by an authorized prescriber.</text> </paragraph> <paragraph num="(5)"> <text>“Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Interim box” means a tamper evident and secure container or secure electronic storage system holding minimal quantities of medications agreed on by the health care facility intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.</text> </paragraph> <paragraph num="(7)"> <text>Remote Automated Medication System.</text> <paragraph num="(a)"> <text>“Remote automated medication system” means an automated medication system that is located in a health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, that does not have an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.</text> </paragraph> <paragraph num="(b)"> <text>“Remote automated medication system” does not include an interim box or other similar medication storage container that:</text> <paragraph num="(i)"> <text>Does not operate pursuant to the entry of a medication order;</text> </paragraph> <paragraph num="(ii)"> <text>Does not require a pharmacist’s review before access to medication;</text> </paragraph> <paragraph num="(iii)"> <text>Is stocked with unit dose medications;</text> </paragraph> <paragraph num="(iv)"> <text>Has the sole purpose of providing a medication dosage pending the next pharmacy delivery to the health care facility;</text> </paragraph> <paragraph num="(v)"> <text>Is located in a patient care setting that does not have a pharmacy on site; and</text> </paragraph> <paragraph num="(vi)"> <text>Is stocked and controlled by a pharmacy providing services to a health care facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Responsible pharmacist” means a licensed pharmacist who ensures the safe and efficient dispensing, repackaging, delivery, control, positive drug identification including bar coding, transaction records, dispensation records, labeling, and accountability for medications in an automated medication system.</text> </paragraph> <paragraph num="(9)"> <text>“Starter dose” means a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.</text> </paragraph> <paragraph num="(10)"> <text>“Unit dose” means a medication container or package containing one discrete pharmaceutical dosage form labeled according to federal and State law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Limitation on Privileges to Administer."> <text>In this chapter, “privileges to administer medication” does not include privileges created by delegation from a licensed health care professional to an unlicensed health care professional.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Usage Requirements for Centralized Automated Medication Systems."> <paragraph num="A."> <text>An automated medication system may only be used if:</text> <paragraph num="(1)"> <text>Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the centralized automated medication system; and</text> </paragraph> <paragraph num="(3)"> <text>The permit holder ensures that:</text> <paragraph num="(a)"> <text>Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The centralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and</text> </paragraph> <paragraph num="(c)"> <text>The centralized automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A permit holder shall indicate on the initial, renewal, and reinstatement applications:</text> <paragraph num="(1)"> <text>Whether the permit holder operates a centralized automated medication system; and</text> </paragraph> <paragraph num="(2)"> <text>Any other information regarding the system that the Board considers necessary to determine compliance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Usage Requirements for Decentralized Automated Medication Systems."> <paragraph num="A."> <text>A decentralized automated medication system may only be used if:</text> <paragraph num="(1)"> <text>Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the automated medication system;</text> </paragraph> <paragraph num="(3)"> <text>Except for starter doses, a licensed pharmacist reviews each order for medication:</text> <paragraph num="(a)"> <text>After the order has been entered into the system; and</text> </paragraph> <paragraph num="(b)"> <text>Before the system permits access to the medication;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The permit holder ensures that:</text> <paragraph num="(a)"> <text>Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The decentralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and</text> </paragraph> <paragraph num="(c)"> <text>The decentralized automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if:</text> <paragraph num="(1)"> <text>The pharmacist reviews the order within 24 hours of removal from the decentralized automated medication system; or</text> </paragraph> <paragraph num="(2)"> <text>The prescriber reviews the patient medical history and authorizes the administration of the dose to the patient.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Decentralized automated medication systems shall operate in a manner which:</text> <paragraph num="(1)"> <text>Limits simultaneous access to multiple:</text> <paragraph num="(a)"> <text>Drug strengths;</text> </paragraph> <paragraph num="(b)"> <text>Dosage forms; or</text> </paragraph> <paragraph num="(c)"> <text>Drug entities;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prevents access to medications not ordered for the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the decentralized automated medication system.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The requirements listed in §C(1) and (2) of this regulation do not apply to automated supply towers which contain:</text> <paragraph num="(1)"> <text>Noncontrolled medications that are:</text> <paragraph num="(a)"> <text>Refrigerated;</text> </paragraph> <paragraph num="(b)"> <text>Bulk; or</text> </paragraph> <paragraph num="(c)"> <text>Intravenous fluids; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prescription devices.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A permit holder shall indicate on the initial, renewal, and reinstatement applications:</text> <paragraph num="(1)"> <text>Whether the permit holder operates a decentralized automated medication system; and</text> </paragraph> <paragraph num="(2)"> <text>Any other information regarding the system that the Board considers necessary to determine compliance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Usage Requirements for Remote Automated Medication Systems."> <paragraph num="A."> <text>A remote automated medication system may only be used if:</text> <paragraph num="(1)"> <text>Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the remote automated medication system;</text> </paragraph> <paragraph num="(3)"> <text>Except for starter doses, a licensed pharmacist reviews each order for medication:</text> <paragraph num="(a)"> <text>After the order has been entered into the system; and</text> </paragraph> <paragraph num="(b)"> <text>Before the system permits access to the medication;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The permit holder ensures that:</text> <paragraph num="(a)"> <text>Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>The remote automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and</text> </paragraph> <paragraph num="(c)"> <text>The remote automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if the pharmacist reviews the order within 24 hours of removal from the remote automated medication system.</text> </paragraph> <paragraph num="C."> <text>If a licensed pharmacist is not physically present where the remote automated medication system is located, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient operation of the system.</text> </paragraph> <paragraph num="D."> <text>Remote automated medication systems shall operate in a manner which:</text> <paragraph num="(1)"> <text>Unless packaging and labeling for a specific patient, limits simultaneous access to multiple:</text> <paragraph num="(a)"> <text>Drug strengths;</text> </paragraph> <paragraph num="(b)"> <text>Dosage forms; or</text> </paragraph> <paragraph num="(c)"> <text>Drug entities;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prevents access to medication not ordered for the patient; and</text> </paragraph> <paragraph num="(3)"> <text>Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the remote automated medication system.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The requirements listed in §D(1) and (2) of this regulation do not apply to automated supply towers which contain:</text> <paragraph num="(1)"> <text>Noncontrolled medications that are:</text> <paragraph num="(a)"> <text>Refrigerated;</text> </paragraph> <paragraph num="(b)"> <text>Bulk; or</text> </paragraph> <paragraph num="(c)"> <text>Intravenous fluids; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prescription devices.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A remote automated medication system may be used only if the system:</text> <paragraph num="(1)"> <text>Uses positive drug identification, such as bar code technology, to ensure accuracy in:</text> <paragraph num="(a)"> <text>Loading and selection of medications in the pharmacy for stocking and replenishment of the remote automated medication system; and</text> </paragraph> <paragraph num="(b)"> <text>Loading medications into the remote automated medication system where it is located;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has electronic reporting capability regarding the identity of persons with access to the system and regarding medications removed from the system;</text> </paragraph> <paragraph num="(3)"> <text>Restricts access to medications to a licensed pharmacist or an individual authorized to administer medication under Health Occupation Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Before administration of a medication to a patient, provides:</text> <paragraph num="(a)"> <text>A picture of the medication, if available; or</text> </paragraph> <paragraph num="(b)"> <text>If a picture is not available, a written description of the medication specifically by color, shape, and unique manufacturer markings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The permit holder shall ensure that the health care facility where the remote automated medication system is located provides, at a minimum:</text> <paragraph num="(1)"> <text>A licensed pharmacist available for consultation 24 hours per day;</text> </paragraph> <paragraph num="(2)"> <text>Technical assistance regarding operation of the system available 24 hours per day; and</text> </paragraph> <paragraph num="(3)"> <text>A quality assurance program as set forth in Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A permit holder shall indicate on the initial, renewal, and reinstatement applications:</text> <paragraph num="(1)"> <text>Whether the permit holder operated a remote automated medication system; and</text> </paragraph> <paragraph num="(2)"> <text>Any other information regarding the system that the Board considers necessary to determine compliance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Stocking of Automated Medication Systems."> <paragraph num="A."> <text>Selection of Medication for Stocking. A licensed pharmacist shall verify the accuracy of medications selected for stocking and replenishment of the automated medication system before the medications are stocked in the system.</text> </paragraph> <paragraph num="B."> <text>Stocking of Automated Medication System. A registered pharmacy technician may stock an automated medication system provided that:</text> <paragraph num="(1)"> <text>The pharmacy technician’s selection of medications is verified by a pharmacist; and</text> </paragraph> <paragraph num="(2)"> <text>The system uses positive drug identification such as bar code technology.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Return of Unused Medication."> <paragraph num="A."> <text>Single-Drug Unit Dose Packaging.</text> <paragraph num="(1)"> <text>Automated medication systems that distribute medications in single-drug unit dose packaging may allow for return of unused medications to the system provided that:</text> <paragraph num="(a)"> <text>The medication is returned to a designated common, secure, one-way returns bin; and</text> </paragraph> <paragraph num="(b)"> <text>A licensed pharmacist determines whether the medication is in an unadulterated form.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Only a licensed pharmacist may return medications directly to the automated medication system under §A(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unused medications distributed from a remote or decentralized automated medication system in a manner other than single-drug unit dose packaging shall be:</text> <paragraph num="(1)"> <text>Returned to a designated common, secure, one-way returns bin; and</text> </paragraph> <paragraph num="(2)"> <text>Returned to the permit holder for proper disposal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unused medications dispensed from a centralized automated medication system stocked with bulk medications may not be returned to the system.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Education and Training."> <text>The permit holder shall ensure that individuals authorized to utilize centralized, decentralized, or remote automated medication systems receive initial and annual training regarding:</text> <paragraph num="A."> <text>The capabilities and limitations of the system;</text> </paragraph> <paragraph num="B."> <text>Procedures for the operation of the system; and</text> </paragraph> <paragraph num="C."> <text>Procedures for system downtime.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Assurance Program."> <paragraph num="A."> <text>The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the automated medication system that addresses, at minimum:</text> <paragraph num="(1)"> <text>A testing program which includes daily accuracy sampling that verifies the integrity of the system;</text> </paragraph> <paragraph num="(2)"> <text>Investigation of medication errors related to the automated medication system, and remedial actions taken;</text> </paragraph> <paragraph num="(3)"> <text>Review of discrepancies and transaction reports to identify patterns of inappropriate use and access;</text> </paragraph> <paragraph num="(4)"> <text>Review of the overall functioning of the system2;</text> </paragraph> <paragraph num="(5)"> <text>Security and access:</text> </paragraph> <paragraph num="(6)"> <text>Preventative maintenance;</text> </paragraph> <paragraph num="(7)"> <text>Sanitation;</text> </paragraph> <paragraph num="(8)"> <text>Storage conditions;</text> </paragraph> <paragraph num="(9)"> <text>Inventory of drugs;</text> </paragraph> <paragraph num="(10)"> <text>Drug procurement, delivery, and receipt;</text> </paragraph> <paragraph num="(11)"> <text>Record keeping;</text> </paragraph> <paragraph num="(12)"> <text>Proper labeling procedures; and</text> </paragraph> <paragraph num="(13)"> <text>Protocols in the event of a power outage or other situation in which the services of the system are interrupted, that include:</text> <paragraph num="(a)"> <text>A plan for insuring continuity of pharmacy services to patients; and</text> </paragraph> <paragraph num="(b)"> <text>A plan for system recovery.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the remote or decentralized automated medication system that addresses, at a minimum, system override management to include:</text> <paragraph num="(1)"> <text>A list of medications that can be overridden which is limited to starter doses; and</text> </paragraph> <paragraph num="(2)"> <text>Review of system overrides to ensure appropriate utilization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Record Keeping."> <paragraph num="A."> <text>The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years.</text> </paragraph> <paragraph num="B."> <text>The records referred to in §A of this regulation shall include:</text> <paragraph num="(1)"> <text>Maintenance records and service logs;</text> </paragraph> <paragraph num="(2)"> <text>System failure reports;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of patient outcomes resulting from system failures;</text> </paragraph> <paragraph num="(4)"> <text>Accuracy audits and system performance audits;</text> </paragraph> <paragraph num="(5)"> <text>Copies of reports and analyses generated as part of the quality assurance program, including daily accuracy sampling;</text> </paragraph> <paragraph num="(6)"> <text>Reports or databases related to level of access and changes in the level of access to the system;</text> </paragraph> <paragraph num="(7)"> <text>Training records including:</text> <paragraph num="(a)"> <text>Contents of the training program;</text> </paragraph> <paragraph num="(b)"> <text>Dates of training completion; and</text> </paragraph> <paragraph num="(c)"> <text>The identity of those attending the training program;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Records of destruction of medication waste removed from the system, to include an independent witness signature; and</text> </paragraph> <paragraph num="(9)"> <text>Transaction information as follows:</text> <paragraph num="(a)"> <text>Transactions involving medications stored in or removed, dispensed, or distributed from the system;</text> </paragraph> <paragraph num="(b)"> <text>Medications dispensed or distributed for a patient, which shall be recorded to include the:</text> <paragraph num="(i)"> <text>Identity of the particular automated medication system accessed;</text> </paragraph> <paragraph num="(ii)"> <text>Identification of the individual accessing the system;</text> </paragraph> <paragraph num="(iii)"> <text>Date of transaction;</text> </paragraph> <paragraph num="(iv)"> <text>Name, strength, dosage form, and quantity of drug accessed; and</text> </paragraph> <paragraph num="(v)"> <text>Name of the patient for whom the drug was accessed; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Records of stocking or removal of medications from an automated medication system, which shall include the:</text> <paragraph num="(i)"> <text>Date;</text> </paragraph> <paragraph num="(ii)"> <text>Name, strength, dosage form, and quantity of drug stocked or removed; and</text> </paragraph> <paragraph num="(iii)"> <text>Name, initials, or identification code of the individual stocking or removing drugs from the system.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Security."> <paragraph num="A."> <text>The responsible pharmacist shall ensure the security of the automated medication system.</text> </paragraph> <paragraph num="B."> <text>In order to restrict access to the automated medication system to authorized individuals, the responsible pharmacist shall, at a minimum:</text> <paragraph num="(1)"> <text>Establish a clear process of how passwords will be assigned;</text> </paragraph> <paragraph num="(2)"> <text>Develop procedures that prohibit the sharing of passwords and reuse of passwords;</text> </paragraph> <paragraph num="(3)"> <text>Require that the system database be updated daily to remove inactive passwords; and</text> </paragraph> <paragraph num="(4)"> <text>Require remote locking mechanisms for refrigerated storage associated with the system.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Laws and Compendial Standards."> <text>The responsible pharmacist shall ensure compliance with the laws and compendial standards for packaging and labeling.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Controlled Dangerous Substances."> <text>Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable State and federal statutes and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205(a) and 12-605, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 1, 2012 (39:7 Md. R. 493)</annotation> </annotations> </chapter> <chapter num="29" heading="Drug Therapy Management"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Amendment” means a change to:</text> <paragraph num="(a)"> <text>A protocol or prescriber-pharmacist agreement; or</text> </paragraph> <paragraph num="(b)"> <text>The parties to the prescriber-pharmacist agreement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Applicants” means physicians, pharmacists, podiatrists, or certified advanced practice nurses with prescriptive authority submitting a prescriber-pharmacist agreement and protocol to their respective Boards.</text> </paragraph> <paragraph num="(2-1)"> <text>“Authorized prescriber” means a licensed physician, licensed podiatrist, or certified advanced practice nurse with prescriptive authority under Health Occupations Article, §8-508, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Boards” means the Board of Physicians, the Board of Pharmacy, the Board of Podiatric Medical Examiners, and the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Condition” means a disease-state or health circumstance necessitating monitoring or intervention.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency first care” means triage of emergent conditions or treatment of the condition in those cases in which a protocol specifies treatment for the emergent condition.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Content of Protocol."> <paragraph num="A."> <text>A protocol shall:</text> <paragraph num="(1)"> <text>Be:</text> <paragraph num="(a)"> <text>Written; and</text> </paragraph> <paragraph num="(b)"> <text>Condition or disease-state specific; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Contain the following:</text> <paragraph num="(a)"> <text>The condition that the protocol is designed to manage;</text> </paragraph> <paragraph num="(b)"> <text>A list of medications that may be used under the auspices of the protocol;</text> </paragraph> <paragraph num="(c)"> <text>Monitoring parameters including laboratory tests for the:</text> <paragraph num="(i)"> <text>Condition; and</text> </paragraph> <paragraph num="(ii)"> <text>Medication employed;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement;</text> </paragraph> <paragraph num="(e)"> <text>A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber unless permitted in the therapy management contract;</text> </paragraph> <paragraph num="(f)"> <text>A list of circumstances under which the pharmacist may alter doses, modify the treatment regimen, or switch the agent under the terms of the therapy management contract;</text> </paragraph> <paragraph num="(g)"> <text>Information to be documented;</text> </paragraph> <paragraph num="(h)"> <text>A listing of provisions within the protocol that may be customized within a therapy management contract; and</text> </paragraph> <paragraph num="(i)"> <text>An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A protocol may authorize:</text> <paragraph num="(1)"> <text>The modification, continuation, and discontinuation of drug therapy;</text> </paragraph> <paragraph num="(2)"> <text>The ordering of laboratory tests;</text> </paragraph> <paragraph num="(3)"> <text>Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and</text> </paragraph> <paragraph num="(4)"> <text>For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement.</text> </paragraph> <paragraph num="D."> <text>Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Content of Prescriber-Pharmacist Agreement."> <paragraph num="A."> <text>The prescriber-pharmacist agreement shall contain the following:</text> <paragraph num="(1)"> <text>The names and signatures of the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists authorized to act under a therapy management contract;</text> </paragraph> <paragraph num="(2)"> <text>The locations where the pharmacists may provide therapy management services;</text> </paragraph> <paragraph num="(3)"> <text>The titles of the protocols to which the prescriber-pharmacist agreement pertains;</text> </paragraph> <paragraph num="(4)"> <text>The methods and time frames by which documentation and routine communication will occur between the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and the pharmacists, including the time frames in which the pharmacist will fully update the patient’s record in writing;</text> </paragraph> <paragraph num="(5)"> <text>The name, address, and telephone number of the party to the prescriber-pharmacist agreement who is to receive correspondence from the Boards related to the prescriber-pharmacist agreement;</text> </paragraph> <paragraph num="(6)"> <text>A statement that the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists shall comply with all State and federal laws relating to patient confidentiality; and</text> </paragraph> <paragraph num="(7)"> <text>A list of devices available to the pharmacists performing under the prescriber-pharmacist agreement, which are relevant to the disease-states or conditions to be managed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technical modifications to the prescriber-pharmacist agreement shall be registered with the Board of Pharmacy within 30 days of the technical modification.</text> </paragraph> <paragraph num="C."> <text>The party designated as the contact person to receive correspondence from the Boards shall ensure that the parties to the prescriber-pharmacist agreement are notified in a timely manner of the information received from the Boards.</text> </paragraph> <paragraph num="D."> <text>If the contact information for the party to the agreement designated to receive correspondence from the Boards changes, the designee shall notify the Boards of the change within 30 days of the change.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Participation in Drug Therapy Management."> <paragraph num="A."> <text>In order to enter into a therapy management contract, a pharmacist:</text> <paragraph num="(1)"> <text>Shall be licensed by and in good standing with the Board of Pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>Shall possess a Doctor of Pharmacy degree or equivalent training as established in §B of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>May not have:</text> <paragraph num="(a)"> <text>A public final order by the Board of Pharmacy disciplining the pharmacist's license within the 5 years immediately before the application is submitted; or</text> </paragraph> <paragraph num="(b)"> <text>Limitations placed on the pharmacist's license by the Board of Pharmacy in a public order;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall possess relevant advanced training as indicated by one of the following:</text> <paragraph num="(a)"> <text>Certification as a specialist related to the disease state specified by the protocol by:</text> <paragraph num="(i)"> <text>The Board of Pharmacy Specialties;</text> </paragraph> <paragraph num="(ii)"> <text>The American Society of Consultant Pharmacist's Certified Geriatric Practitioner certification program; or</text> </paragraph> <paragraph num="(iii)"> <text>Another credentialing body approved by the Board of Pharmacy; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Successful completion of:</text> <paragraph num="(i)"> <text>A residency accredited by the American Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy or offered by a body accredited by the Accreditation Council for Pharmacy Education;</text> </paragraph> <paragraph num="(ii)"> <text>A certificate program approved by the Board of Pharmacy;</text> </paragraph> <paragraph num="(iii)"> <text>A National Association of Boards of Pharmacy credentialing examination; or</text> </paragraph> <paragraph num="(iv)"> <text>An examination approved by the Board of Pharmacy;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shall have successfully completed:</text> <paragraph num="(a)"> <text>1,000 hours of relevant clinical experience; or</text> </paragraph> <paragraph num="(b)"> <text>320 hours in a structured experience program approved by the Board of Pharmacy; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Shall document training related to the disease state specified in the protocol.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacist who does not possess a Doctor of Pharmacy degree shall document that the pharmacist's training has included the following components:</text> <paragraph num="(1)"> <text>Designing, implementing, monitoring, evaluating, and modifying or recommending modifications in drug therapy to insure effective, safe, and economical patient care;</text> </paragraph> <paragraph num="(2)"> <text>Identifying, assessing, and solving medication-related problems, and providing clinical judgments as to the continuing effectiveness of individualized therapeutic plans and intended therapeutic outcomes;</text> </paragraph> <paragraph num="(3)"> <text>Conducting appropriate physical assessments, evaluating patient problems, and ordering and monitoring medications and laboratory tests in accordance with established standards of practice;</text> </paragraph> <paragraph num="(4)"> <text>Monitoring patients and patient populations regarding the purposes, uses, effects, and pharmacoeconomics of their medications and related therapy;</text> </paragraph> <paragraph num="(5)"> <text>Providing emergency first care, including cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(6)"> <text>Using clinical data to optimize therapeutic drug regimens; and</text> </paragraph> <paragraph num="(7)"> <text>Documenting interventions and evaluating pharmaceutical care outcomes.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board of Pharmacy shall determine whether the pharmacist meets the requirements of §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>An authorized prescriber who has entered into a prescriber-pharmacist agreement shall submit to the Boards that regulate the authorized prescriber a copy of:</text> <paragraph num="(1)"> <text>The prescriber-pharmacist agreement;</text> </paragraph> <paragraph num="(2)"> <text>Subsequent amendments made to the:</text> <paragraph num="(a)"> <text>Prescriber-pharmacist agreement; or</text> </paragraph> <paragraph num="(b)"> <text>Protocols specified in the prescriber-pharmacist agreement; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Changes to participants of the:</text> <paragraph num="(a)"> <text>Prescriber-pharmacist agreement; or</text> </paragraph> <paragraph num="(b)"> <text>Protocols specified in the prescriber-pharmacist agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Boards that regulate the authorized prescriber shall notify the authorized prescriber of any additional information needed within 30 days of the receipt of the submitted information.</text> </paragraph> <paragraph num="F."> <text>A licensed pharmacist who has entered into a prescriber-pharmacist agreement shall submit to the Board of Pharmacy a copy of:</text> <paragraph num="(1)"> <text>The prescriber-pharmacist agreement;</text> </paragraph> <paragraph num="(2)"> <text>Subsequent amendments made to the:</text> <paragraph num="(a)"> <text>Prescriber-pharmacist agreement; or</text> </paragraph> <paragraph num="(b)"> <text>Protocols specified in the prescriber-pharmacist agreement; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Changes to participants of the:</text> <paragraph num="(a)"> <text>Prescriber-pharmacist agreement; or</text> </paragraph> <paragraph num="(b)"> <text>Protocols specified in the prescriber-pharmacist agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The Board of Pharmacy shall determine whether a pharmacist added under §F of this regulation meets the requirements of §§A and B of this regulation.</text> </paragraph> <paragraph num="H."> <text>The Board of Pharmacy shall notify the pharmacist of any additional information needed within 30 days of the receipt of the submitted information.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Guidelines for Use of Protocols."> <paragraph num="A."> <text>On receipt of specific instructions from the authorized prescriber regarding a specific patient, the pharmacist may execute the authorized prescriber’s specific instructions even if the instructions deviate from the protocol.</text> </paragraph> <paragraph num="B."> <text>The protocol may not prohibit the pharmacist from providing other pharmaceutical services that are within the pharmacist's scope of practice.</text> </paragraph> <paragraph num="C."> <text>Documentation of activities performed under a protocol or the authorized prescriber’s specific instructions shall be maintained in such a manner that it is accessible to the:</text> <paragraph num="(1)"> <text>Authorized prescriber; and</text> </paragraph> <paragraph num="(2)"> <text>Pharmacist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Documentation may be maintained in written or electronic form.</text> </paragraph> <paragraph num="E."> <text>Oral communications between the authorized prescriber and pharmacist shall be summarized in the documentation maintained by the pharmacist and forwarded to the authorized prescriber.</text> </paragraph> <paragraph num="F."> <text>Unless an alternative time period is stated in the prescriber-pharmacist agreement, the pharmacist shall inform the authorized prescriber within 48 hours if the pharmacist:</text> <paragraph num="(1)"> <text>Modifies the dose or agent under the therapy management contract;</text> </paragraph> <paragraph num="(2)"> <text>Detects an abnormal result from an assessment activity; or</text> </paragraph> <paragraph num="(3)"> <text>Initiates drug therapy under a written, disease-state specific protocol, for protocols by a licensed physician and pharmacist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Therapy Management Contracts."> <paragraph num="A."> <text>A therapy management contract shall be signed by the:</text> <paragraph num="(1)"> <text>Authorized prescriber or authorized prescribers involved in the management of the patient under a prescriber-pharmacist agreement;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacist or pharmacists involved in the management of the patient under a prescriber-pharmacist agreement; and</text> </paragraph> <paragraph num="(3)"> <text>Patient receiving care under the therapy management contract.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A therapy management contract shall contain:</text> <paragraph num="(1)"> <text>A list of allowable substitutions of chemically dissimilar drugs, if any;</text> </paragraph> <paragraph num="(2)"> <text>A statement that:</text> <paragraph num="(a)"> <text>None of the parties involved in the therapy management contract have been:</text> <paragraph num="(i)"> <text>Coerced into participating in the therapy management contract;</text> </paragraph> <paragraph num="(ii)"> <text>Given economic incentives, excluding normal reimbursement for services rendered; or</text> </paragraph> <paragraph num="(iii)"> <text>Involuntarily required to participate in the therapy management contract; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The pharmacist shall notify the authorized prescriber under the terms of the prescriber-pharmacist agreement if the pharmacist:</text> <paragraph num="(i)"> <text>Modifies the dose or agent under the therapy management contract; or</text> </paragraph> <paragraph num="(ii)"> <text>Detects an abnormal result from an assessment activity;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notice to the patient stating:</text> <paragraph num="(a)"> <text>That the patient may terminate the therapy management contract at any time; and</text> </paragraph> <paragraph num="(b)"> <text>The procedure by which the patient may terminate the therapy management contract;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A procedure for periodic review by the authorized prescriber of the drugs modified under the prescriber-pharmacist agreement or changed with the consent of the authorized prescriber;</text> </paragraph> <paragraph num="(5)"> <text>A reference to the protocol or protocols under which the pharmacist shall act; and</text> </paragraph> <paragraph num="(6)"> <text>Exceptions or limitations to the protocol or protocols for the specific patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Fees."> <paragraph num="A."> <text>Scope. This regulation governs authorized prescribers and pharmacists participating in drug therapy management or amendment of authorized prescribers and pharmacists that participate in the prescriber-pharmacist agreements relating to drug therapy management.</text> </paragraph> <paragraph num="B."> <text>Fees. The Board of Pharmacy requires a fee for the prescriber-pharmacist agreement and protocol application (which includes review of the qualifications of the pharmacist participants) of $100 per prescriber-pharmacist agreement.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-6A-01 — 12-6A-10, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 11, 2003 (30:24 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 28, 2016 (43:6 Md. R. 409)</annotation> </annotations> </chapter> <chapter num="30" heading="Change to Permit — Pharmacy or Wholesale Distribution Permit Holder"> <regulation prefix="Regulation" num=".01" heading="Application for Name Change."> <text>The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if:</text> <paragraph num="A."> <text>The permit holder submits a notice of name change to the Board within 30 days after the name change, on a form that the Board requires;</text> </paragraph> <paragraph num="B."> <text>The permit holder submits to the Board documentation verifying the name change; and</text> </paragraph> <paragraph num="C."> <text>There is no other change in the individual or entity required to possess a pharmacy or wholesale distribution permit including no change in controlling ownership interest, type of business entity, or location.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for Name Change — Fee."> <text>There is no fee for a name change under this chapter.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership."> <text>If the controlling interest in ownership of a pharmacy or wholesale distributor changes, the new owner shall:</text> <paragraph num="A."> <text>Submit an initial application and fee for a pharmacy or wholesale distributor permit, as applicable; and</text> </paragraph> <paragraph num="B."> <text>Submit and comply with the requirements of closing and opening operations as set forth in:</text> <paragraph num="(1)"> <text>COMAR 10.34.14, for pharmacies; and</text> </paragraph> <paragraph num="(2)"> <text>Health Occupations Article, §12-6C-05(d), Annotated Code of Maryland, and COMAR 10.34.22.10, for wholesale distributors.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Applications for Pharmacy or Wholesale Distributor Establishment Change of Location."> <paragraph num="A."> <text>Permits issued to operate a pharmacy or engage in wholesale distribution, whether located in the State or outside the State, are:</text> <paragraph num="(1)"> <text>Not transferable; and</text> </paragraph> <paragraph num="(2)"> <text>Specific to the establishment location that has undergone an opening inspection by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy or wholesale distributor that intends to change its establishment location shall:</text> <paragraph num="(1)"> <text>Submit an application to the Board on a form required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>If located in the State, comply with opening and closing inspection requirements in order to:</text> <paragraph num="(a)"> <text>Commence operations at the new establishment location; and</text> </paragraph> <paragraph num="(b)"> <text>Cease operations at the existing establishment location; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If located outside the State, submit an inspection report for the new location conducted by the authorized entity in the state in which the establishment is located, or provide documentation of supplemental accreditation, if applicable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Change of Information Provided in Applications."> <text>Notwithstanding any other reporting requirements, a permit holder shall provide written notification to the Board at least 30 days prior to any change in information in its application provided to the Board, to include:</text> <paragraph num="A."> <text>Change in hours of operation; or</text> </paragraph> <paragraph num="B."> <text>Change in the physical structure of the establishment, to include any:</text> <paragraph num="(1)"> <text>Deviation from the floorplan submitted by the permit holder as part of the application; or</text> </paragraph> <paragraph num="(2)"> <text>Other change that may affect the security or storage conditions of prescription drugs or devices.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Incomplete Applications."> <paragraph num="A."> <text>The Board may hold an incomplete initial or reinstatement application for a license, registration, or permit for up to one year from the date of receipt.</text> </paragraph> <paragraph num="B."> <text>After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.</text> </paragraph> <paragraph num="C."> <text>If an application has been closed under §B of this regulation, the applicant shall submit a new application fee and otherwise comply with all applicable license, registration, or permit requirements.</text> </paragraph> <paragraph num="D."> <text>If an applicant presents extenuating circumstances to the Board, the Board may, in its sole discretion, extend the 1-year application completion period.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 8, 2013 (40:13 Md. R. 1076)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective July 8, 2013 (40:13 Md. R. 1076)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 20, 2019 (46:10 Md. R. 489)</annotation> </annotations> </chapter> <chapter num="31" heading="Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit"> <regulation prefix="Regulation" num=".01" heading="Settings."> <paragraph num="A."> <text>If a setting otherwise complies with State and federal laws, a pharmacist may request Board approval to dispense or distribute at a setting that does not possess a pharmacy permit if:</text> <paragraph num="(1)"> <text>The dispensing or distribution occurs while the pharmacist is providing drug therapy management services in:</text> <paragraph num="(a)"> <text>The office of a licensed physician;</text> </paragraph> <paragraph num="(b)"> <text>A clinic; or</text> </paragraph> <paragraph num="(c)"> <text>A medical facility; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The setting is:</text> <paragraph num="(a)"> <text>Operated or funded by a public health authority of the State;</text> </paragraph> <paragraph num="(b)"> <text>A medical facility or clinic that is operated on a nonprofit basis and is not otherwise required to possess a pharmacy permit; or</text> </paragraph> <paragraph num="(c)"> <text>A health center that operates on a campus of an institution of higher education.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the drug therapy management services referred to in §A(1)(a) of this regulation include the dispensing or distribution of controlled dangerous substances, the request may be approved by the Board if the physician possesses a dispensing permit issued by the Board of Physicians.</text> </paragraph> <paragraph num="C."> <text>If a pharmacist seeks to obtain Board approval to dispense or distribute at a setting that is not set forth in §A of this regulation, the pharmacist shall apply to the Board for a waiver permit under COMAR 10.34.17.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Pharmacist Approval."> <paragraph num="A."> <text>Before a pharmacist may dispense or distribute at a setting that does not hold a pharmacy permit under Regulation .01A(1) of this chapter, the pharmacist shall submit to the Board a request for approval signed by the pharmacist, which includes:</text> <paragraph num="(1)"> <text>The name and license number of the pharmacist;</text> </paragraph> <paragraph num="(2)"> <text>The scope of services to be provided by the pharmacist at the nonpharmacy setting;</text> </paragraph> <paragraph num="(3)"> <text>The name and address of the nonpharmacy setting where the pharmacist intends to dispense or distribute; and</text> </paragraph> <paragraph num="(4)"> <text>A statement indicating the pharmacist's criminal history, if any.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the pharmacist intends to provide drug therapy management services in a licensed physician's office under Regulation .01A(1)(a) of this chapter, in addition to the requirements of §A of this regulation, the pharmacist shall provide:</text> <paragraph num="(1)"> <text>The name and license number of the licensed physician; and</text> </paragraph> <paragraph num="(2)"> <text>Proof of an approved physician-pharmacist agreement with the licensed physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Grounds for Denial."> <text>The Board may deny a pharmacist's request for approval under Regulation .02 of this chapter if the:</text> <paragraph num="A."> <text>Pharmacist has:</text> <paragraph num="(1)"> <text>A pending or final disciplinary action before the Board; or</text> </paragraph> <paragraph num="(2)"> <text>A criminal history; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>Criteria set forth in Regulations .01B or .02 of this chapter are not satisfied.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Change in Information."> <text>If any of the information set forth in Regulation .02 of this chapter changes during the effective period of the Board's approval:</text> <paragraph num="A."> <text>The pharmacist shall immediately advise the Board in writing of the change; and</text> </paragraph> <paragraph num="B."> <text>The change in information may cause the Board to withdraw or modify the Board's approval of the nonpharmacy setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Approval During Catastrophic Health Emergency."> <text>In the event of a catastrophic health emergency proclaimed by the Governor under Article 41, §2-202, Annotated Code of Maryland, or by the Secretary under Health-General Article, §18-902, Annotated Code of Maryland, assignment of a pharmacist to a location by the State constitutes application and approval under Regulation .02 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Governing Laws."> <paragraph num="A."> <text>Except as provided in §B of this regulation, a pharmacist approved by the Board to dispense or distribute at a nonpharmacy setting shall comply with the Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A pharmacist approved by the Board to dispense or distribute at a nonpharmacy setting shall comply with the labeling, storage, and record keeping requirements governing the nonpharmacy setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Term and Renewal."> <paragraph num="A."> <text>Unless otherwise determined by the Board, the Board's approval of a pharmacist's request to dispense or distribute at a setting that does not possess a pharmacy permit is in effect until the expiration of the pharmacist's license.</text> </paragraph> <paragraph num="B."> <text>The pharmacist shall request renewal of the Board's approval when renewing the pharmacist's license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Pharmacy Rendered Inoperable."> <paragraph num="A."> <text>If a pharmacy for which a permit is issued is destroyed or otherwise rendered inoperable, a pharmacist may dispense or distribute from a temporary site if the permit holder:</text> <paragraph num="(1)"> <text>Obtains approval from the Board before continuing pharmacy operations from a temporary site; and</text> </paragraph> <paragraph num="(2)"> <text>Ensures that the temporary pharmacy site complies with State and federal laws.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Under §A of this regulation, the Board may approve the operation of a pharmacy from a temporary site for a period not to exceed 60 days from the date of the original approval, unless an extension is approved by the Board before the expiration of the preceding approval.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-307, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 1, 2004 (31:4 Md. R. 317)</annotation> </annotations> </chapter> <chapter num="32" heading="Pharmacist Administration of Vaccinations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed.</text> </paragraph> <paragraph num="(3)"> <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Pharmacy permit holder” means a person authorized by the Board to operate a pharmacy while the pharmacy permit is effective.</text> </paragraph> <paragraph num="(5)"> <text>“Pharmacy Experiential Program” means a program under the American Council on Pharmacy Education.</text> </paragraph> <paragraph num="(6)"> <text>“Practice pharmacy” means to engage in the activities set forth in Health Occupations Article, §12-101(x)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Primary care provider” means a health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual.</text> </paragraph> <paragraph num="(8)"> <text>“Vaccination” means:</text> <paragraph num="(a)"> <text>A vaccination that is listed in the Centers for Disease Control and Prevention’s Recommended Immunization Adult Schedule;</text> </paragraph> <paragraph num="(b)"> <text>A vaccination recommended in the Centers for Disease Control and Prevention’s Health Information for International Travel;</text> </paragraph> <paragraph num="(c)"> <text>A vaccination recommended for individuals between 7 years old and 18 years old by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for Persons aged 0 through 18 years old;</text> </paragraph> <paragraph num="(d)"> <text>An influenza vaccination;</text> </paragraph> <paragraph num="(e)"> <text>A COVID vaccination; or</text> </paragraph> <paragraph num="(f)"> <text>A vaccination approved or authorized by the U.S. Food and Drug Administration.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Vaccine information statement” means the information sheet, produced by the Centers for Disease Control and Prevention that explains both the benefits and risks of a specific vaccine to the vaccine recipient, their parent, or their legal representative.</text> </paragraph> </paragraph> <annotations> <annotation type="Emergency Action">52:25 25-248-E (Regulations .02—.08) EMERGENCY ACTION IN EFFECT 11/20/2025 —5/19/2026</annotation> </annotations> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements to Administer Vaccinations."> <paragraph num="A."> <text>Registration.</text> <paragraph num="(1)"> <text>A licensed pharmacist shall submit a registration to the Board on the form that the Board requires.</text> </paragraph> <paragraph num="(2)"> <text>The registration form shall include verification from the licensed pharmacist of the following:</text> <paragraph num="(a)"> <text>That the pharmacist has completed a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education and includes education on:</text> <paragraph num="(i)"> <text>Hands-on injection techniques;</text> </paragraph> <paragraph num="(ii)"> <text>Clinical evaluation of indication and contraindications of vaccines;</text> </paragraph> <paragraph num="(iii)"> <text>The recognition and treatment of emergency reaction to vaccines; and</text> </paragraph> <paragraph num="(iv)"> <text>Guidelines and recommendations of the Centers for Disease Control and Prevention regarding vaccinations in effect on December 31, 2024; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Possession of an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A registration authorizing a licensed pharmacist to administer vaccinations expires with the expiration of the license to practice pharmacy unless the licensed pharmacist has completed:</text> <paragraph num="(a)"> <text>Two hours of continuing education credits related to vaccinations; and</text> </paragraph> <paragraph num="(b)"> <text>All other requirements for licensure renewal.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensed pharmacist may not administer vaccinations until the licensed pharmacist receives a written confirmation from the Board accepting the licensed pharmacist's registration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 3 years old provided that:</text> <paragraph num="(1)"> <text>The vaccine is:</text> <paragraph num="(a)"> <text>An influenza vaccine;</text> </paragraph> <paragraph num="(b)"> <text>A COVID vaccine; or</text> </paragraph> <paragraph num="(c)"> <text>Used in response to a public health emergency; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall:</text> <paragraph num="(a)"> <text>Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>Refer the child vaccination patient to a pediatric care provider when appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B-1."> <paragraph num="(1)"> <text>A pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 7 years old provided that:</text> <paragraph num="(a)"> <text>The vaccine:</text> <paragraph num="(i)"> <text>Is recommended by the Center for Disease Control and Prevention Advisory Committee on Immunization Practices; or</text> </paragraph> <paragraph num="(ii)"> <text>Approved or authorized by the U.S. Food and Drug Administration; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall:</text> <paragraph num="(i)"> <text>Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and</text> </paragraph> <paragraph num="(ii)"> <text>Refer the child vaccination patient to a pediatric care provider when appropriate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices cited in this regulation refer to federal statutes, rules, and guidance:</text> <paragraph num="(a)"> <text>In effect on December 31, 2024; or</text> </paragraph> <paragraph num="(b)"> <text>At a later date to account for any new vaccines recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices after December 31, 2024.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B-2."> <text>A licensed pharmacist may order and administer to an adult a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter that is listed in the Center for Disease Control and Prevention’s Health Information for International Travel.</text> </paragraph> <paragraph num="C."> <text>A pharmacist shall report to the ImmuNet Program established under Health-General Article, §18-109, Annotated Code of Maryland, a vaccination administered by the pharmacist to an individual.</text> </paragraph> <paragraph num="D."> <text>A pharmacist shall:</text> <paragraph num="(1)"> <text>Have proof of active certification in basic cardiopulmonary resuscitation readily available.</text> </paragraph> <paragraph num="(2)"> <text>Provide the patient with a vaccine information statement issued by the Centers for Disease Control and Prevention;</text> </paragraph> <paragraph num="(3)"> <text>Obtain a signed consent form from the patient or custodial parent; and</text> </paragraph> <paragraph num="(4)"> <text>Observe the patient for a period of at least 15 minutes after administration of the vaccine for adverse effects including syncope.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A pharmacy student in a Pharmacy Experiential Program, who has successfully completed a Board-approved certification course, may administer vaccinations under direct supervision of a licensed pharmacist who meets requirements in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Record Keeping."> <paragraph num="A."> <text>The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes:</text> <paragraph num="(1)"> <text>The name, address, and date of birth of the individual receiving the vaccination;</text> </paragraph> <paragraph num="(2)"> <text>The date of administration and route and site of vaccinations;</text> </paragraph> <paragraph num="(3)"> <text>The name, dose, manufacturer’s lot number, and expiration date of the vaccine;</text> </paragraph> <paragraph num="(4)"> <text>The name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text> </paragraph> <paragraph num="(5)"> <text>The name of the pharmacist, pharmacy student, physician, or nurse administering the vaccination;</text> </paragraph> <paragraph num="(6)"> <text>The version of the vaccination information statement provided to the individual receiving the vaccination;</text> </paragraph> <paragraph num="(7)"> <text>The copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text> </paragraph> <paragraph num="(8)"> <text>The nature and outcome of an adverse reaction and documentation that the adverse reaction was reported to:</text> <paragraph num="(a)"> <text>The primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>The Vaccine Adverse Event Reporting System.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text> </paragraph> <paragraph num="(10)"> <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The records required in this regulation shall be:</text> <paragraph num="(1)"> <text>Readily retrievable;</text> </paragraph> <paragraph num="(2)"> <text>Made available on the request of the Board;</text> </paragraph> <paragraph num="(3)"> <text>Except for records related to minor patients, maintained for a minimum of 5 years; and</text> </paragraph> <paragraph num="(4)"> <text>In the case of a minor patient, maintained until the patient attains the age of majority plus 3 years or for 5 years after the record is made, whichever is later.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The pharmacist administering a vaccination as an independent provider at a location that is not a pharmacy shall maintain the following documentation for a minimum of 5 years:</text> <paragraph num="(1)"> <text>Name, address, and date of birth of the individual receiving the vaccination;</text> </paragraph> <paragraph num="(2)"> <text>Date of administration, and route and site of vaccinations;</text> </paragraph> <paragraph num="(3)"> <text>Name, dose, manufacturer's lot number, and expiration date of the vaccine;</text> </paragraph> <paragraph num="(4)"> <text>Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text> </paragraph> <paragraph num="(5)"> <text>Name of the pharmacist or pharmacy student administering the vaccination;</text> </paragraph> <paragraph num="(6)"> <text>Version of the vaccination information statement provided to the individual receiving the vaccination;</text> </paragraph> <paragraph num="(7)"> <text>Copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text> </paragraph> <paragraph num="(8)"> <text>Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:</text> <paragraph num="(a)"> <text>The primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>The Vaccine Adverse Event Reporting System.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text> </paragraph> <paragraph num="(10)"> <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The pharmacist administering a vaccination on behalf of a permit holder at a location that is not a pharmacy shall maintain the following documentation with the permit holder for a minimum of 5 years:</text> <paragraph num="(1)"> <text>Name, address, and date of birth of the individual receiving the vaccination;</text> </paragraph> <paragraph num="(2)"> <text>Date of administration, and route and site of vaccinations;</text> </paragraph> <paragraph num="(3)"> <text>Name, dose, manufacturer's lot number, and expiration date of the vaccine;</text> </paragraph> <paragraph num="(4)"> <text>Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text> </paragraph> <paragraph num="(5)"> <text>Name of the pharmacist or pharmacy student administering the vaccination;</text> </paragraph> <paragraph num="(6)"> <text>Version of the vaccination information statement provided to the individual receiving the vaccination;</text> </paragraph> <paragraph num="(7)"> <text>Copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text> </paragraph> <paragraph num="(8)"> <text>Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:</text> <paragraph num="(a)"> <text>The primary care provider; and</text> </paragraph> <paragraph num="(b)"> <text>The Vaccine Adverse Event Reporting System.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text> </paragraph> <paragraph num="(10)"> <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Information and Consent."> <paragraph num="A."> <text>Every patient receiving a vaccination shall be provided with a current vaccine information statement.</text> </paragraph> <paragraph num="B."> <text>Every patient receiving a vaccination shall:</text> <paragraph num="(1)"> <text>Sign a consent form consenting to the administration of the vaccine; and</text> </paragraph> <paragraph num="(2)"> <text>Be given a copy of the consent form for the patient's future reference.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The consent form shall disclose the credentials of the pharmacist administering the vaccination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Approved Protocols."> <paragraph num="A."> <text>A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination.</text> </paragraph> <paragraph num="B."> <text>The pharmacist shall administer vaccinations in accordance with the written protocol.</text> </paragraph> <paragraph num="C."> <text>The written protocol for each vaccine shall contain at least the following elements:</text> <paragraph num="(1)"> <text>Identity and license number of the participating pharmacist;</text> </paragraph> <paragraph num="(2)"> <text>Vaccine;</text> </paragraph> <paragraph num="(3)"> <text>Precautions to vaccine use;</text> </paragraph> <paragraph num="(4)"> <text>Contraindications to vaccine use;</text> </paragraph> <paragraph num="(5)"> <text>Process to be followed for screening for:</text> <paragraph num="(a)"> <text>Indications;</text> </paragraph> <paragraph num="(b)"> <text>Precautions;</text> </paragraph> <paragraph num="(c)"> <text>Contraindications; and</text> </paragraph> <paragraph num="(d)"> <text>Allergies;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Process for obtaining and documenting consent;</text> </paragraph> <paragraph num="(7)"> <text>Process for verification of prescription for patients 11—17 years old for vaccinations other than the influenza vaccine;</text> </paragraph> <paragraph num="(8)"> <text>Dose or doses of the vaccine that will be administered;</text> </paragraph> <paragraph num="(9)"> <text>The route or routes and site or sites of administration of the vaccine;</text> </paragraph> <paragraph num="(10)"> <text>The injection or administration procedures;</text> </paragraph> <paragraph num="(11)"> <text>Post-vaccination procedures, including waiting requirements;</text> </paragraph> <paragraph num="(12)"> <text>Process for handling adverse reactions, including but not limited to:</text> <paragraph num="(a)"> <text>Acute anaphylactic reactions; and</text> </paragraph> <paragraph num="(b)"> <text>Other acute emergencies; and</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Process for documenting and maintaining a vaccination record including at least:</text> <paragraph num="(a)"> <text>Patient:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(iii)"> <text>Address;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Vaccination administration:</text> <paragraph num="(i)"> <text>Date;</text> </paragraph> <paragraph num="(ii)"> <text>Dose;</text> </paragraph> <paragraph num="(iii)"> <text>Site; and</text> </paragraph> <paragraph num="(iv)"> <text>Route;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Vaccine:</text> <paragraph num="(i)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(ii)"> <text>Lot number; and</text> </paragraph> <paragraph num="(iii)"> <text>Expiration date;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Required Vaccine Information Statement:</text> <paragraph num="(i)"> <text>Version; and</text> </paragraph> <paragraph num="(ii)"> <text>Provision date;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Name of the patient’s primary care provider or prescriber;</text> </paragraph> <paragraph num="(f)"> <text>Documentation:</text> <paragraph num="(i)"> <text>Of at least one attempt to inform the patient’s primary care provider or prescriber that the vaccination has been administered; or</text> </paragraph> <paragraph num="(ii)"> <text>That the patient has no primary care provider;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and</text> </paragraph> <paragraph num="(h)"> <text>The name of the vaccinator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The protocol shall be:</text> <paragraph num="(1)"> <text>Signed and dated at least annually by the pharmacist;</text> </paragraph> <paragraph num="(2)"> <text>Available and presented for inspection to the Board of Pharmacy upon request; and</text> </paragraph> <paragraph num="(3)"> <text>Reviewed and updated as necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Fees."> <text>Fees charged for the administration of vaccinations may not exceed $50 in addition to the cost of each vaccination.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-101, 12-102(b), 12-508, and 12-6A-10, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective December 16, 2005 (33:1 Md. R. 34); adopted permanently effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 2, 2007 (34:13 Md. R. 1151)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective July 2, 2007 (34:13 Md. R. 1151)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 1, 2009 (36:15 Md. R. 1167)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective October 1, 2011 (38:24 Md. R. 1495); amended permanently effective January 23, 2012 (39:1 Md. R. 18)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 28, 2014 (41:8 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04— .08 amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266)</annotation> </annotations> </chapter> <chapter num="33" heading="Prescription Drug Repository Program"> <regulation prefix="Regulation" num=".01-1" heading="Incorporation by Reference."> <text>In this chapter, the Secure and Responsible Drug Disposal Act of 2010, 21 U.S.C. 822 (as amended), has been incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(1-1)"> <text>“Donation program” means pharmacies that voluntarily participate as a drop-off site or repository, or both, to accept donated drugs or medical supplies for purposes of re-dispensing those donated drugs or medical supplies to needy individuals.</text> </paragraph> <paragraph num="(1-2)"> <text>“Disposal program” means pharmacies that voluntarily participate as repositories to collect returned drugs and medical supplies for purposes of safe disposal.</text> </paragraph> <paragraph num="(2)"> <text>“Drop-off site” means a pharmacy or other health care facility designated by the Board for the purpose of receiving donated prescription drugs or medical supplies as part of the donation program and forwarding the drugs or medical supplies to a repository.</text> </paragraph> <paragraph num="(3)"> <text>Health Care Facility.</text> <paragraph num="(a)"> <text>“Health care facility” means:</text> <paragraph num="(i)"> <text>A hospital, as defined in Health-General Article, §19-301(g), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A limited service hospital, as defined in Health-General Article, §19-301(e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A related institution, as defined in Health-General Article, §19-301(o), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>An ambulatory surgical facility;</text> </paragraph> <paragraph num="(v)"> <text>A rehabilitation facility;</text> </paragraph> <paragraph num="(vi)"> <text>A home health agency, as defined in Health-General Article, §19-401(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(vii)"> <text>A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(viii)"> <text>A kidney disease treatment facility, or the kidney disease treatment stations and services provided by or on behalf of a hospital, if the facility or the services do not include kidney transplant services or programs;</text> </paragraph> <paragraph num="(ix)"> <text>The office of one or more individuals licensed to practice dentistry under Health Occupations Article, Title 4, Annotated Code of Maryland, for the purposes of practicing dentistry;</text> </paragraph> <paragraph num="(x)"> <text>A comprehensive care facility located in Maryland; or</text> </paragraph> <paragraph num="(xi)"> <text>Other health institutions, services, or programs that may be specified as requiring a Certificate of Need under State law.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care facility” does not mean a hospital or related institution operated, or listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession and has prescribing authority in this State.</text> </paragraph> <paragraph num="(5)"> <text>“Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed.</text> </paragraph> <paragraph num="(6)"> <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Program” means the Prescription Drug Repository Program.</text> </paragraph> <paragraph num="(8)"> <text>“Repository” means a pharmacy that applies to and is designated by the Board for the purpose of:</text> <paragraph num="(a)"> <text>Accepting, inspecting, and dispensing donated prescription drugs or medical supplies received from a drop-off site as part of the donation program; and</text> </paragraph> <paragraph num="(b)"> <text>Collecting prescription drugs or medical supplies for disposal as part of the disposal program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Donation Program — Eligible Drugs."> <paragraph num="A."> <text>Prescription drugs or medical supplies may be donated at a drop-off site.</text> </paragraph> <paragraph num="B."> <text>Prescription drugs or medical supplies may be accepted for dispensing if the prescription drugs and medical supplies are:</text> <paragraph num="(1)"> <text>In their original unopened and sealed packaging; or</text> </paragraph> <paragraph num="(2)"> <text>Packaged in single unit doses when the outside packaging is opened if the single unit dose packaging is undisturbed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Donation Program — Ineligible Drugs."> <paragraph num="A."> <text>Prescription drugs or medical supplies may not be accepted for dispensing if the prescription drugs or medical supplies:</text> <paragraph num="(1)"> <text>Bear an expiration date that is less than 90 days from the date the drug is donated to ensure the potency and quality of the prescription drugs or medical supplies;</text> </paragraph> <paragraph num="(2)"> <text>Have been adulterated, according to the standards of Health-General Article, §21-216, Annotated Code of Maryland, because adulterated prescription drugs or medical supplies have been determined to be a threat to public health;</text> </paragraph> <paragraph num="(3)"> <text>Are designated controlled dangerous substances by the U.S. Drug Enforcement Administration which has determined that controlled dangerous substances may not be donated under a repository program;</text> </paragraph> <paragraph num="(4)"> <text>Require refrigeration because the potency and quality may not be guaranteed; or</text> </paragraph> <paragraph num="(5)"> <text>Have been previously compounded because compounded prescription drugs are patient specific.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The repository shall dispose of donated prescription drugs or medical supplies if they are not accepted into the Program for the purpose of dispensing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Donation Program — Donor Form."> <paragraph num="A."> <text>A donor of a prescription drug or medical supply shall sign a form containing the following statements:</text> <paragraph num="(1)"> <text>That the donor is the owner or the owner's representative of the prescription drug or medical supply; and</text> </paragraph> <paragraph num="(2)"> <text>That the donor intends to voluntarily donate the prescription drug or medical supply to the Program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The drop-off site shall:</text> <paragraph num="(1)"> <text>Require that the donor form contain:</text> <paragraph num="(a)"> <text>The signature of the donor or the donor's representative;</text> </paragraph> <paragraph num="(b)"> <text>Contact information of the donor or the donor's representative; and</text> </paragraph> <paragraph num="(c)"> <text>The date of donation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Require that the donor form be completed before any donation;</text> </paragraph> <paragraph num="(3)"> <text>Provide a copy of the donor form to the donor or the donor's representative; and</text> </paragraph> <paragraph num="(4)"> <text>Maintain a copy of the donor form for 5 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Donation Program — Drop-Off Sites Requirements."> <paragraph num="A."> <text>In order to become a drop-off site, a pharmacy or other health care facility:</text> <paragraph num="(1)"> <text>Shall submit an application to the Board to be designated as a voluntary drop-off site;</text> </paragraph> <paragraph num="(2)"> <text>Shall be in good standing with the Board or the Office of Health Care Quality;</text> </paragraph> <paragraph num="(3)"> <text>May not have a final disciplinary order issued against it by a health occupations board;</text> </paragraph> <paragraph num="(4)"> <text>May not be owned or operated by a health care practitioner who has not fulfilled the requirements of a final disciplinary order that may have been issued against the owner or operator by a health occupations boards;</text> </paragraph> <paragraph num="(5)"> <text>Shall maintain records of donated prescription drugs or medical supplies; and</text> </paragraph> <paragraph num="(6)"> <text>Shall assign a pharmacist or other health care practitioner the responsibility to accept donated prescription drugs or medical supplies at the drop-off site.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Assigned Pharmacist or Other Health Care Practitioner's Responsibility. A pharmacist or health care practitioner accepting donated prescription drugs or medical supplies at a drop-off site as set forth in §A(6) of this regulation:</text> <paragraph num="(1)"> <text>May not delegate acceptance of donated prescription drugs or medical supplies;</text> </paragraph> <paragraph num="(2)"> <text>May refuse to accept hazardous prescription drugs or medical supplies for donation if the decision is based on professional judgment, experience, knowledge, or available reference materials;</text> </paragraph> <paragraph num="(3)"> <text>Shall be in good standing with the pharmacist's or health care practitioner's respective health occupations board; and</text> </paragraph> <paragraph num="(4)"> <text>Shall have fulfilled the requirements of a final disciplinary order that may have been issued against the pharmacist or health care practitioner by a health occupations board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Record Requirements. A drop-off site shall:</text> <paragraph num="(1)"> <text>Obtain a signed donor form releasing the prescription drug or medical supplies to the Program;</text> </paragraph> <paragraph num="(2)"> <text>Provide a copy of the signed donor form to the donor; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain records of signed donor forms for 5 years.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Procedures for Handling of Donated Prescription Drugs or Medical Supplies.</text> <paragraph num="(1)"> <text>A drop-off site shall:</text> <paragraph num="(a)"> <text>Place the donated prescription drug or medical supply and the donor form in a sealed bag;</text> </paragraph> <paragraph num="(b)"> <text>Store the bag containing the donated prescription drugs or medical supplies in an area accessible only to those pharmacists or health care practitioners who have been assigned the responsibility to accept the donated prescription drugs or medical supplies; and</text> </paragraph> <paragraph num="(c)"> <text>Forward the sealed bags of donated prescription drugs or medical supplies to the repository at least every 2 weeks.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A drop-off site may not:</text> <paragraph num="(a)"> <text>Dispense donated prescription drugs or medical supplies;</text> </paragraph> <paragraph num="(b)"> <text>Resell prescription drugs or medical supplies donated to the Program;</text> </paragraph> <paragraph num="(c)"> <text>Charge a fee for accepting a donation;</text> </paragraph> <paragraph num="(d)"> <text>Accept donated prescription drugs or medical supplies until the drop-off site applicant has been approved by the Board; or</text> </paragraph> <paragraph num="(e)"> <text>Accept prescription drugs for disposal.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06-1" heading="Repositories Participating in the Donation Program."> <paragraph num="A."> <text>Designated Pharmacist. A repository in the donation program shall designate a pharmacist who shall:</text> <paragraph num="(1)"> <text>Accept donated prescription drugs or medical supplies forwarded by:</text> <paragraph num="(a)"> <text>A drop-off site; or</text> </paragraph> <paragraph num="(b)"> <text>A manufacturer regulated by the U.S. Food and Drug Administration;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Inspect donated prescription drugs or medical supplies;</text> </paragraph> <paragraph num="(3)"> <text>Accept donated prescription drugs or medical supplies that meet the requirements of Regulations .02 and .03 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Obliterate from the labels of donated prescription drugs or medical supplies patient specific information for which the donated prescription drugs or medical supplies were originally dispensed when it is placed in inventory.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Record Requirements. A repository in the Donation Program shall:</text> <paragraph num="(1)"> <text>Maintain a separate inventory of donated prescription drugs or medical supplies for a minimum of 5 years;</text> </paragraph> <paragraph num="(2)"> <text>Maintain separate prescription files for patients receiving donated prescription drugs or medical supplies for a minimum of 5 years; and</text> </paragraph> <paragraph num="(3)"> <text>Submit an annual report on its activities to the Board that includes at least information on the:</text> <paragraph num="(a)"> <text>Number of recipients by county;</text> </paragraph> <paragraph num="(b)"> <text>Approximate market value of the prescription drugs or medical supplies dispensed;</text> </paragraph> <paragraph num="(c)"> <text>50 prescription drugs or medical supplies most frequently dispensed; and</text> </paragraph> <paragraph num="(d)"> <text>Total number of donations to the Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures for Handling of Donated Prescription Drugs or Medical Supplies.</text> <paragraph num="(1)"> <text>A repository in the Donation Program shall store donated prescription drugs or medical supplies in a secure location separate from other inventory in accordance with State and federal laws and regulations.</text> </paragraph> <paragraph num="(2)"> <text>A repository may not:</text> <paragraph num="(a)"> <text>Resell prescription drugs or medical supplies donated to the Program; or</text> </paragraph> <paragraph num="(b)"> <text>Establish or maintain a waiting list for prescription drugs or medical supplies dispensed by the Program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A repository may charge a fee of not more than $10 for each prescription drug or medical supply dispensed under the Program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Limitations. A repository in the Donation Program is under no obligation to obtain a prescription drug or medical supply that is not in inventory at the time of the request.</text> </paragraph> <paragraph num="E."> <text>Procedure for Dispensing Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall dispense donated prescription drugs or medical supplies in compliance with applicable federal and State laws and regulations for dispensing prescription drugs or medical supplies.</text> </paragraph> <paragraph num="F."> <text>Procedure for Shipping Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall comply with COMAR 10.34.25 when shipping donated prescription drugs or medical supplies to recipients of this Program.</text> </paragraph> <paragraph num="G."> <text>Procedures for Disposing of Donated Prescription Drugs or Medical Supplies.</text> <paragraph num="(1)"> <text>A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies that do not meet the eligibility requirements of Regulation .02 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies in compliance with applicable State and federal laws and regulations for disposing of prescription drugs or medical supplies.</text> </paragraph> <paragraph num="(3)"> <text>A repository shall maintain records of disposal of donated prescription drugs or medical supplies.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Determination of Patient Eligibility for the Donation Program.</text> <paragraph num="(1)"> <text>A recipient of the Donation Program shall be a resident of the State.</text> </paragraph> <paragraph num="(2)"> <text>A health care practitioner with prescribing authority shall:</text> <paragraph num="(a)"> <text>Determine, at the health care practitioner’s discretion, the financial need of a patient to participate in the Donation Program; and</text> </paragraph> <paragraph num="(b)"> <text>Indicate on the patient’s prescription eligibility for the Donation Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Recipient Form. Recipients of a donated prescription drug or medical supply under the Donation Program shall sign a Board approved form before receiving the prescription drug or medical supply to confirm that the recipient understands that:</text> <paragraph num="(1)"> <text>The recipient is receiving prescription drugs or medical supplies that have been donated as part of the Donation Program; and</text> </paragraph> <paragraph num="(2)"> <text>Entities involved in the Donation Program have immunity from liability in accordance with Health-General Article, §15-607, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Repositories — General Requirements."> <text>In order to become a repository, a pharmacy:</text> <paragraph num="A."> <text>Shall submit an application to the Board to be designated as a repository;</text> </paragraph> <paragraph num="B."> <text>Shall indicate on the application to the Board if the applicant intends to:</text> <paragraph num="(1)"> <text>Participate in the Donation Program;</text> </paragraph> <paragraph num="(2)"> <text>Participate in the Disposal Program by collecting only non-controlled dangerous substances and medical supplies for safe disposal; or</text> </paragraph> <paragraph num="(3)"> <text>Participate in the Disposal Program by collecting controlled dangerous substances, non-controlled dangerous substances, and medical supplies for safe disposal;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall be in good standing with the Board;</text> </paragraph> <paragraph num="D."> <text>May not have a final disciplinary order issued against it by the Board; and</text> </paragraph> <paragraph num="E."> <text>May not be owned or operated by a health care practitioner who has not fulfilled the requirements of a final disciplinary order that may have been issued against the owner or operator by a health occupations board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disposal Program — Requirements."> <paragraph num="A."> <text>Pharmacies that collect returned prescription drugs or medical supplies for proper disposal shall be approved by the Board as repositories.</text> </paragraph> <paragraph num="B."> <text>Repositories that collect only non-controlled dangerous substances for proper disposal shall:</text> <paragraph num="(1)"> <text>Dispose of prescription drugs or medical supplies collected for disposal in compliance with applicable State and federal laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Have policies and procedures regarding the safe and secure handling and disposal of prescription drugs and medical supplies, to include specific guidelines for prescription drugs requiring special disposal or care;</text> </paragraph> <paragraph num="(3)"> <text>Dispose of collected prescription drugs and medical supplies through a third party processor or a reverse distributor, as appropriate; and</text> </paragraph> <paragraph num="(4)"> <text>Maintain a separate secure container behind the prescription counter that is clearly marked for the Disposal Program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacist may not delegate to a pharmacy technician the collection of prescription drugs or medical supplies under §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Repositories that collect controlled dangerous substances for disposal:</text> <paragraph num="(1)"> <text>Shall comply with the requirements of the Secure and Responsible Drug Disposal Act of 2010;</text> </paragraph> <paragraph num="(2)"> <text>May collect non-controlled dangerous substances and medical supplies in the same manner; and</text> </paragraph> <paragraph num="(3)"> <text>May commingle the collection of controlled and non-controlled dangerous substances and medical supplies in accordance with the Secure and Responsible Drug Disposal Act of 2010.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§15-601 — 15-609, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 29, 2007 (34:2 Md. R. 137)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 9, 2016 (43:9 Md. R. 530)</annotation> </annotations> </chapter> <chapter num="34" heading="Pharmacy Technicians"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to applicants for registration as pharmacy technicians and to registered pharmacy technicians.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>Compounding.</text> <paragraph num="(a)"> <text>“Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:</text> <paragraph num="(i)"> <text>As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or</text> </paragraph> <paragraph num="(ii)"> <text>For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Delegated Pharmacy Act.</text> <paragraph num="(a)"> <text>“Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Delegated pharmacy act” does not include:</text> <paragraph num="(i)"> <text>An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee;</text> </paragraph> <paragraph num="(iii)"> <text>A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Direct supervision” means that a licensed pharmacist is physically available onsite to supervise the performance of delegated pharmacy acts.</text> </paragraph> <paragraph num="(5)"> <text>“Experiential learning rotation” means a course offered by an Accreditation Council for Pharmacy Education accredited school of pharmacy that is designed to provide pharmacy practice experiences to students seeking the doctor of pharmacy degree.</text> </paragraph> <paragraph num="(6)"> <text>Final Product Verification.</text> <paragraph num="(a)"> <text>“Final product verification” means:</text> <paragraph num="(i)"> <text>Confirming the accuracy of the device or drug product, and dosage form of a filled prescription or medication order; or</text> </paragraph> <paragraph num="(ii)"> <text>Confirming the accuracy of the device or drug product, and dosage form of a prescription or medication selected for stocking into a medication distribution system.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Final product verification” does not include determining the appropriateness of the prescription device or drug product, dosage form, directions for use, labeling, packaging, or any other determination that requires the application of a pharmacist’s clinical expertise.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Medication distribution system” means an automated medication system, emergency box, interim box, medication carousel or cart, or other storage and dispensing system.</text> </paragraph> <paragraph num="(8)"> <text>“National pharmacy technician certification program” means a program approved by a Board-recognized national accrediting body.</text> </paragraph> <paragraph num="(9)"> <text>“Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education.</text> </paragraph> <paragraph num="(10)"> <text>“Pharmacy technician trainee” means an individual engaged in a Board-approved pharmacy technician training program.</text> </paragraph> <paragraph num="(11)"> <text>“Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text> </paragraph> <paragraph num="(12)"> <text>“Registration” means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.</text> </paragraph> <paragraph num="(13)"> <text>“Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.</text> </paragraph> <paragraph num="(14)"> <text>“Unit dose” means a package labeled with bar code scanning or other similar technology containing a single dose of a device, drug, or medication ordered or prescribed for a patient.</text> </paragraph> <paragraph num="(15)"> <text>“Unit-of-use” means a package or container, such as a unit dose (injectable, liquid, or solid), otic, ophthalmic product, otic product, topical product, or a prescription vial filled from a stock bottle or in the original manufacturer’s packaging, designed to be dispensed to a patient that is labeled with bar code scanning or other similar technology.</text> </paragraph> <paragraph num="(16)"> <text>“Validated pharmacy technician” means a registered pharmacy technician who has obtained a product verification certificate issued by a Board-approved national training program and satisfied other regulatory requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Delegated Pharmacy Acts."> <paragraph num="A."> <text>A pharmacy technician may not:</text> <paragraph num="(1)"> <text>Represent themselves as a pharmacist;</text> </paragraph> <paragraph num="(2)"> <text>Dispense prescription medications when the pharmacist is not in the pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>Be present in the pharmacy when the pharmacist is not physically available onsite;</text> </paragraph> <paragraph num="(4)"> <text>Provide information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices;</text> </paragraph> <paragraph num="(5)"> <text>Delegate a pharmacy act that was delegated to the pharmacy technician or individual engaging in a Board-approved technician training program;</text> </paragraph> <paragraph num="(6)"> <text>Act within the parameters of a therapy management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Provide the final verification for accuracy, appropriateness, completeness, or validity of a filled prescription or medication order, except as provided for in Regulation .04 under this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Make decisions that require a pharmacist's professional judgment;</text> </paragraph> <paragraph num="(9)"> <text>Clinically evaluate the patient's profile relative to the pharmaceuticals that have been or will be dispensed;</text> </paragraph> <paragraph num="(10)"> <text>Consult with the patient concerning the utilization of their pharmaceuticals;</text> </paragraph> <paragraph num="(11)"> <text>Accept or transcribe new prescriptions;</text> </paragraph> <paragraph num="(12)"> <text>Give or accept a transferred prescription for controlled dangerous substances;</text> </paragraph> <paragraph num="(13)"> <text>Accept a transferred prescription;</text> </paragraph> <paragraph num="(14)"> <text>Independently compound prescriptions;</text> </paragraph> <paragraph num="(15)"> <text>Administer medications;</text> </paragraph> <paragraph num="(16)"> <text>Accept the return of prescription drugs or devices directly from a patient.</text> </paragraph> <paragraph num="(17)"> <text>Administer an injectable medication; or</text> </paragraph> <paragraph num="(18)"> <text>Except as provided in §B of this regulation, administer a vaccine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Technician Administration of Certain Vaccines.</text> <paragraph num="(1)"> <text>A registered pharmacy technician that meets the requirements set forth in §B(2) and (3) of this regulation, may administer the following vaccines as a delegated pharmacy act:</text> <paragraph num="(a)"> <text>Coronavirus (COVID-19), influenza, or pneumococcal pneumonia vaccines to an individual 18 years old or older; or</text> </paragraph> <paragraph num="(b)"> <text>Respiratory syncytial virus (RSV) or herpes zoster vaccines to an individual 50 years old or older.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In order for a registered pharmacy technician to administer a vaccine, the registered pharmacy technician shall submit notification to the Board on a form that the Board requires attesting to the following:</text> <paragraph num="(a)"> <text>Successful completion of a practical training program approved by the Accreditation Council for Pharmacy Education (ACPE) that includes:</text> <paragraph num="(i)"> <text>Hands-on injection technique;</text> </paragraph> <paragraph num="(ii)"> <text>Clinical evaluation of indications and contraindications of vaccines; and</text> </paragraph> <paragraph num="(iii)"> <text>Recognition and treatment of emergency reactions to vaccines; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Possession of an active certification in basic cardiopulmonary resuscitation (CPR) obtained through in-person classroom instruction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A registered pharmacy technician may not administer a vaccine as a delegated pharmacy act until the registered pharmacy technician receives written confirmation from the Board accepting the notification form.</text> </paragraph> <paragraph num="(4)"> <text>The delegating supervising pharmacist shall confirm that a registered pharmacy technician has met the requirements set forth in §B(2) and (3) of this regulation before delegating the administration of a vaccine to the registered pharmacy technician.</text> </paragraph> <paragraph num="(5)"> <text>A pharmacy technician trainee may not administer a vaccine.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy technician shall be clearly identified as such to the public;</text> </paragraph> <paragraph num="D."> <text>When performing tasks in the prescription area, a pharmacy technician shall maintain proper:</text> <paragraph num="(1)"> <text>Sanitation;</text> </paragraph> <paragraph num="(2)"> <text>Hygiene;</text> </paragraph> <paragraph num="(3)"> <text>Biohazard precautions; and</text> </paragraph> <paragraph num="(4)"> <text>Infection control.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Off-Site Data Entry.</text> <paragraph num="(1)"> <text>Except as provided in §E(2) of this regulation, a registered pharmacy technician shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.</text> </paragraph> <paragraph num="(2)"> <text>A registered pharmacy technician may perform prescription data entry at a remote location outside of a licensed pharmacy provided that:</text> <paragraph num="(a)"> <text>The registered pharmacy technician has immediate electronic access to a supervising pharmacist who can assist as needed;</text> </paragraph> <paragraph num="(b)"> <text>The data entry is not required to be performed by a pharmacist;</text> </paragraph> <paragraph num="(c)"> <text>The data entry is appropriate to the education, training, and experience of the registered pharmacy technician and supervising pharmacist; and</text> </paragraph> <paragraph num="(d)"> <text>If the data entry involves access to protected patient information under the Health Insurance Portability and Accountability Act (HIPAA), it can be performed in a manner that maintains the confidentiality of patient information.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Validated Pharmacy Technician."> <paragraph num="A."> <text>Validated Pharmacy Technician — Minimum Requirements.</text> <paragraph num="(1)"> <text>Experience. Prior to working as a validated pharmacy technician, an individual shall have a minimum of 1 year of experience as a registered pharmacy technician in the State.</text> </paragraph> <paragraph num="(2)"> <text>Training. In addition to the requirements for pharmacy technician registration, to act as a validated pharmacy technician, an individual shall possess an active product verification certificate issued by a Board-approved national pharmacy technician certification program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Validated Pharmacy Technician — Final Product Verification. A pharmacist may delegate responsibility to perform the final verification of a prescription device, drug product, or medication order to a validated pharmacy technician under the following circumstances:</text> <paragraph num="(1)"> <text>Prescription or Medication Order.</text> <paragraph num="(a)"> <text>A pharmacist shall verify the data entry of the prescription device, drug product, or medication order in the pharmacy management system or, if applicable, the electronic health record for:</text> <paragraph num="(i)"> <text>Accuracy;</text> </paragraph> <paragraph num="(ii)"> <text>Appropriateness of the device, drug product, or medication;</text> </paragraph> <paragraph num="(iii)"> <text>Appropriateness of the dosage form;</text> </paragraph> <paragraph num="(iv)"> <text>Directions for use;</text> </paragraph> <paragraph num="(v)"> <text>Labeling;</text> </paragraph> <paragraph num="(vi)"> <text>Packaging; and</text> </paragraph> <paragraph num="(vii)"> <text>Any other determination that requires the application of clinical expertise.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Bar code scanning or similar technology is utilized during the filling process and at the verification step to validate device, drug product, or medication selection accuracy.</text> </paragraph> <paragraph num="(c)"> <text>The product being verified is packaged in unit-dose or unit-of-use packaging.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Stocking or Replenishing a Medication Distribution System. Notwithstanding any other regulation, a validated pharmacy technician may perform the final product verification of a prescription device, drug product, or medication selected for stocking into a medication distribution system provided that:</text> <paragraph num="(a)"> <text>The medication distribution system utilizes bar code scanning or other similar technology to validate the device, drug product, or medication selection; and</text> </paragraph> <paragraph num="(b)"> <text>The pharmacy responsible for the medication distribution system maintains and reviews annually a quality assurance policy which includes routine audits of the system to ensure the accuracy of stocked prescriptions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A validated pharmacy technician may not perform the final product verification of a prescription device, drug product, or medication that the technician personally prepared.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Validated Pharmacy Technician — Pharmacy Permit Holder’s Responsibilities. A pharmacy utilizing a validated pharmacy technician shall maintain records for a minimum of 2 years, and have those records readily available to the Board upon request, including:</text> <paragraph num="(1)"> <text>A current list of all validated pharmacy technicians;</text> </paragraph> <paragraph num="(2)"> <text>A job description for each validated pharmacy technician; and</text> </paragraph> <paragraph num="(3)"> <text>Policies and standard operating procedures for validated pharmacy technicians.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Validated Pharmacy Technician – Pharmacist’s Responsibilities.</text> <paragraph num="(1)"> <text>A pharmacist may not delegate the final product verification of a compounded medication under any circumstance.</text> </paragraph> <paragraph num="(2)"> <text>Notwithstanding any delegation of a pharmacy act to a validated pharmacy technician, a pharmacist shall maintain professional responsibility for every medication or prescription dispensed, and for each medication or prescription stocked into a medication distribution system under the supervision of the pharmacist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration Requirements."> <paragraph num="A."> <text>An applicant currently certified by a national pharmacy technician certification program shall:</text> <paragraph num="(1)"> <text>Submit to the Board a signed completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board evidence of current certification by a national pharmacy certification program;</text> </paragraph> <paragraph num="(3)"> <text>Pay a fee as set forth in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(4)"> <text>Submit a request for a State Criminal History Records check.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant that does not qualify under §A of this regulation shall:</text> <paragraph num="(1)"> <text>Submit to the Board a signed completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Be 17 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Meet the following educational requirements:</text> <paragraph num="(a)"> <text>Be a high school graduate or have attained a high school equivalency diploma;</text> </paragraph> <paragraph num="(b)"> <text>Be enrolled and in good standing at a high school; or</text> </paragraph> <paragraph num="(c)"> <text>Meet the requirements of §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide satisfactory proof to the Board of the applicant's successful completion of a pharmacy technician training program approved by the Board that:</text> <paragraph num="(a)"> <text>Is no longer than 6 months duration; and</text> </paragraph> <paragraph num="(b)"> <text>Includes 160 hours of work experience;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Pass an examination approved by the Board as set forth in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>Pay a fee as set forth in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(7)"> <text>Submit a request for a State Criminal History Records check.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant who does not meet the requirements of §A or B of this regulation shall:</text> <paragraph num="(1)"> <text>Submit to the Board a signed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Comply with the age requirements as set forth in §B of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Provide written verification from the pharmacy permit holder that the applicant has worked in the pharmacy area of a pharmacy operated by the same pharmacy permit holder continuously since January 1, 2006;</text> </paragraph> <paragraph num="(4)"> <text>Provide written verification from the pharmacist who has supervised the applicant for at least 6 months that the applicant has performed competently;</text> </paragraph> <paragraph num="(5)"> <text>Pay a fee as set forth in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(6)"> <text>Submit a request for a State Criminal History Records check.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board of Pharmacy shall provide the pharmacy technician with a registration card and pocket identification card upon initial registration and renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Pharmacy Students —Exemptions."> <paragraph num="A."> <text>Pharmacy students who are practicing in a pharmacy as part of a school of pharmacy sanctioned experiential learning rotation are not subject to the registration requirements of Regulation .04 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Pharmacy students who are currently completing the first year of a professional pharmacy education program and are not in a school of pharmacy sanctioned experiential learning rotation may perform delegated pharmacy acts provided that the pharmacy student:</text> <paragraph num="(1)"> <text>Submits to the Board a signed completed application for exemption from the registration requirements of Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Provides verification of enrollment and good standing at an accredited school of pharmacy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy student may begin work under this exemption upon compliance with §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>An exemption from registration granted under this regulation is effective only during the first year of the pharmacy students professional pharmacy education program.</text> </paragraph> <paragraph num="E."> <text>Pharmacy students granted an exemption from registration under this regulation are not subject to renewal requirements as set forth in Regulation .08 of this chapter.</text> </paragraph> <paragraph num="F."> <text>A pharmacy student granted an exemption from registration under this regulation shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist and in accordance with Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standards for Pharmacy Technician Training Programs."> <paragraph num="A."> <text>Minimum Standards.</text> <paragraph num="(1)"> <text>Pharmacy technician training programs shall, at a minimum, cover the following areas of pharmacy practice:</text> <paragraph num="(a)"> <text>Roles and responsibilities of the pharmacy technician;</text> </paragraph> <paragraph num="(b)"> <text>Knowledge of prescription medications;</text> </paragraph> <paragraph num="(c)"> <text>Knowledge of strengths or dose, dosage forms, physical appearance, routes of administration, and duration of drug therapy;</text> </paragraph> <paragraph num="(d)"> <text>The dispensing process;</text> </paragraph> <paragraph num="(e)"> <text>Pharmaceutical calculations;</text> </paragraph> <paragraph num="(f)"> <text>Interacting with patients;</text> </paragraph> <paragraph num="(g)"> <text>Third party prescriptions;</text> </paragraph> <paragraph num="(h)"> <text>Extemporaneous compounding;</text> </paragraph> <paragraph num="(i)"> <text>Requirements and professional standards for:</text> <paragraph num="(i)"> <text>Preparing;</text> </paragraph> <paragraph num="(ii)"> <text>Labeling;</text> </paragraph> <paragraph num="(iii)"> <text>Dispensing;</text> </paragraph> <paragraph num="(iv)"> <text>Storing;</text> </paragraph> <paragraph num="(v)"> <text>Prepackaging;</text> </paragraph> <paragraph num="(vi)"> <text>Distributing; and</text> </paragraph> <paragraph num="(vii)"> <text>How medications are administered;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Confidentiality;</text> </paragraph> <paragraph num="(k)"> <text>Drugs used to treat the following indications:</text> <paragraph num="(i)"> <text>Hypertension;</text> </paragraph> <paragraph num="(ii)"> <text>Antihyperlipidemia;</text> </paragraph> <paragraph num="(iii)"> <text>Diabetes mellitus;</text> </paragraph> <paragraph num="(iv)"> <text>Arthritis;</text> </paragraph> <paragraph num="(v)"> <text>Gastrointestinal disorders;</text> </paragraph> <paragraph num="(vi)"> <text>Asthma and allergy; and</text> </paragraph> <paragraph num="(vii)"> <text>Infectious diseases;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Federal and State laws and regulations governing the practice of pharmacy; and</text> </paragraph> <paragraph num="(m)"> <text>Knowledge of special dosing considerations for pediatric and geriatric populations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pharmacy technician training programs may be offered by:</text> <paragraph num="(a)"> <text>Pharmacy employers;</text> </paragraph> <paragraph num="(b)"> <text>Nationally recognized pharmacy technician training programs;</text> </paragraph> <paragraph num="(c)"> <text>Accredited educational institutions pharmacy technician programs;</text> </paragraph> <paragraph num="(d)"> <text>Pharmacy technician programs approved by the Maryland State Department of Education and the Maryland Higher Education Commission; and</text> </paragraph> <paragraph num="(e)"> <text>Pharmacy technician training programs offered by the U.S. Armed Forces.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Training programs may not be longer than 6 months.</text> </paragraph> <paragraph num="(4)"> <text>Training programs shall include 160 hours of work experience, which shall be completed within 6 months of the date of the pharmacy technician trainee’s enrollment in the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Board Approval of Pharmacy Technician Training Programs.</text> <paragraph num="(1)"> <text>A program shall submit an application on a form provided by the Board.</text> </paragraph> <paragraph num="(2)"> <text>A program shall provide the Board with the course outline and any other information requested by the Board.</text> </paragraph> <paragraph num="(3)"> <text>A pharmacy that pairs 160 hours of on-site work experience with a pharmacy technician training program that is Board-approved for its didactic content only shall obtain independent Board approval as a pharmacy technician training program prior to the delegation of any pharmacy act to a pharmacy technician trainee.</text> </paragraph> <paragraph num="(4)"> <text>Any changes in course content shall require notification and approval from the Board.</text> </paragraph> <paragraph num="(5)"> <text>The Board shall have final approval of a pharmacy technician training program.</text> </paragraph> <paragraph num="(6)"> <text>The Board may withdraw approval of a program if the Board finds that the program is in violation of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>The Board shall approve pharmacy technician training programs offered by the U.S. Armed Forces.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Standards for Examination Approval."> <text>The Board shall approve examinations which have:</text> <paragraph num="A."> <text>Content criteria set forth in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="B."> <text>A minimum of 100 multiple choice questions;</text> </paragraph> <paragraph num="C."> <text>Sufficient additional questions so that the examination questions may be rotated twice a year; and</text> </paragraph> <paragraph num="D."> <text>A passing score of 75 percent or higher.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Renewal Requirements."> <paragraph num="A."> <text>The pharmacy technician's registration shall expire on the last day of the birth month following 1 year after initial registration.</text> </paragraph> <paragraph num="B."> <text>Following initial registration, a pharmacy technician's registration:</text> <paragraph num="(1)"> <text>Expires on the date set by the Board unless it is renewed for an additional term; and</text> </paragraph> <paragraph num="(2)"> <text>May not be renewed for a term longer than 2 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least 1 month before the registration expires, the Board shall issue a renewal notice to the pharmacy technician registrant that states:</text> <paragraph num="(1)"> <text>The date on which the current registration expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The registrant may renew the registration for an additional term of 2 years if the registrant:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be registered;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a renewal fee set forth in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with the continuing education requirements set forth in Regulation .09 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Continuing Education."> <paragraph num="A."> <text>Requirements.</text> <paragraph num="(1)"> <text>A pharmacy technician registered to practice in Maryland shall:</text> <paragraph num="(a)"> <text>Earn 20 hours of approved continuing pharmaceutical education within the 2-year period immediately preceding the registrant’s renewal application; and</text> </paragraph> <paragraph num="(b)"> <text>If the registrant administers a vaccine in accordance with Regulation .03 of this chapter, earn 2 hours of continuing pharmaceutical education focused on vaccination as part of the 20 hours of continuing pharmaceutical education required for renewal.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For the first renewal period during which continuing education is mandatory for a pharmacy technician, the Board of Pharmacy shall require only 10 hours of continuing education requirements.</text> </paragraph> <paragraph num="(3)"> <text>A pharmacy technician shall:</text> <paragraph num="(a)"> <text>Attest to the fact that the pharmacy technician has completed the continuing pharmacy technician education requirement on the required form; and</text> </paragraph> <paragraph num="(b)"> <text>Retain supporting documents for inspection by the Board for 4 years after the date of renewal for which the continuing education credits were used.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Accredited Continuing Education Providers.</text> <paragraph num="(1)"> <text>The following providers are approved for any programs they offer which otherwise qualify for continuing education credit:</text> <paragraph num="(a)"> <text>Accreditation Council on Pharmaceutical Education (ACPE);</text> </paragraph> <paragraph num="(b)"> <text>All schools of pharmacy accredited by the American Association of Colleges of Pharmacy (AACP); and</text> </paragraph> <paragraph num="(c)"> <text>Out-of-State providers approved by a state board of pharmacy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Procedures for Approval of Additional Programs.</text> <paragraph num="(a)"> <text>Other providers shall initially request Board approval for individual programs.</text> </paragraph> <paragraph num="(b)"> <text>An approved program is valid for a 2-year period.</text> </paragraph> <paragraph num="(c)"> <text>The approved provider shall submit to the Board changes to the program that differ from the initial submission of information for Board approval.</text> </paragraph> <paragraph num="(d)"> <text>Failure to submit to the Board changes to an approved program may result in the Board withdrawing approval of the program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Providers of continuing education shall furnish a certificate of completion to participants who qualify that includes the:</text> <paragraph num="(a)"> <text>Name of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Name of the provider;</text> </paragraph> <paragraph num="(c)"> <text>Description of course work;</text> </paragraph> <paragraph num="(d)"> <text>Number of hours;</text> </paragraph> <paragraph num="(e)"> <text>Date of completion; and</text> </paragraph> <paragraph num="(f)"> <text>Program identification number or provider number on the certificate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Miscellaneous.</text> <paragraph num="(1)"> <text>Credits may not be carried over from one continuing education period to another.</text> </paragraph> <paragraph num="(2)"> <text>The Board of Pharmacy may grant an exception from the continuing education requirements if the pharmacy technician presents evidence that failure to comply was due to circumstances beyond the pharmacy technician's control.</text> </paragraph> <paragraph num="(3)"> <text>Falsifying continuing education records is grounds for disciplinary action under Health Occupations Article, §12-6B-09(2) and (3), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>If the Board provides a form for information, the pharmacy technician shall use the form to supply the requested information to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Reinstatement."> <paragraph num="A."> <text>A pharmacy technician whose Maryland registration expired less than 2 years before applying for reinstatement shall:</text> <paragraph num="(1)"> <text>Complete 20 hours of continuing education; and</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacy technician whose Maryland registration expired more than 2 years before applying for reinstatement, shall:</text> <paragraph num="(1)"> <text>Complete 20 hours of continuing education;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(3)"> <text>Pass a Board-approved exam.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Reciprocity."> <paragraph num="A."> <text>An individual applying to register as a pharmacy technician by reciprocity shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the fee set forth in COMAR 10.34.09; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a request for a State Criminal History Records check.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual applying to register as a pharmacy technician by reciprocity shall:</text> <paragraph num="(1)"> <text>Submit to the Board evidence of the following:</text> <paragraph num="(a)"> <text>Registration in another state under requirements similar to the registration requirements of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Evidence of being in good standing in the state or states of current registration; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Evidence of having worked as a pharmacy technician in another state for at least 6 months.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-101, 12-205, 12-206, 12-315—12-317, 12-319, 12-320, 12-403, 12-505, 12-707, and 12-6B-01—12-6B-14, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 2015 (42:7 Md. R. 569); February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 28, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 11, 2024 (51:22 Md. R. 963)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 11, 2024 (51:22 Md. R. 963)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 11, 2024 (51:22 Md. R. 963)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective November 11, 2024 (51:22 Md. R. 963)</annotation> </annotations> </chapter> <chapter num="35" heading="Infusion Pharmacy Services in an Alternate Site Care Environment"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Alternate site care environment” means the location where the patient is receiving infusion therapy other than an inpatient hospital setting.</text> </paragraph> <paragraph num="(2)"> <text>“Compounding worksheet” means a document or electronic record which:</text> <paragraph num="(a)"> <text>Specifies instructions for a specific compounded parenteral medication;</text> </paragraph> <paragraph num="(b)"> <text>Documents the manufacturer’s:</text> <paragraph num="(i)"> <text>Ingredients;</text> </paragraph> <paragraph num="(ii)"> <text>Lot numbers; and</text> </paragraph> <paragraph num="(iii)"> <text>Expiration dates; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Includes a copy of the prescription label.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Delegated Pharmacy Act.</text> <paragraph num="(a)"> <text>“Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Delegated pharmacy act” does not include:</text> <paragraph num="(i)"> <text>An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Title 12, Subtitle 6A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or Health Occupations Article, Title 12, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>The delegation of a pharmacy act by a pharmacy technician, pharmacy student, or pharmacy technician trainee;</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months; or</text> </paragraph> <paragraph num="(vi)"> <text>The performance of other functions prohibited in regulations adopted by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“End of therapy” means the conclusion of parenteral infusion therapy as ordered by the prescriber.</text> </paragraph> <paragraph num="(5)"> <text>“Infusion nurse” means a registered nurse providing infusion therapy as defined in COMAR 10.27.20.02B in an alternate site environment.</text> </paragraph> <paragraph num="(6)"> <text>“Infusion pharmacy” means a pharmacy that provides pharmaceutical care to patients receiving parenteral therapy in an alternate site care environment.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed authorized prescriber of record” means an individual with the authority to prescribe and monitor a patient’s parenteral infusion therapy for the duration of the patient’s infusion therapy.</text> </paragraph> <paragraph num="(8)"> <text>“Parenteral infusion access device” means, but is not limited to, intravenous, subcutaneous, intrathecal, epidural, or peripheral nerve catheter device through which parenteral medications may be administered.</text> </paragraph> <paragraph num="(9)"> <text>“Patient care plan” means an individualized care plan that reflects the patient’s parenteral infusion therapy pharmaceutical monitoring plan aimed at optimizing the outcome of therapy while minimizing untoward effects from the medication.</text> </paragraph> <paragraph num="(10)"> <text>“Patient triage form” means a written or electronic tool used by a clinician or by a registered pharmacy technician when communicating with a patient, a patient’s caregiver, or an infusion nurse to document the patient’s current status, including but not limited to, the patient’s response to therapy, medication changes or adverse reactions, and pain level.</text> </paragraph> <paragraph num="(11)"> <text>“Permit holder” means a person, corporation, or other legal entity authorized by the Board to establish and operate a pharmacy.</text> </paragraph> <paragraph num="(12)"> <text>“Pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text> </paragraph> <paragraph num="(13)"> <text>“Pharmacist” means an individual who is licensed to practice pharmacy.</text> </paragraph> <paragraph num="(14)"> <text>“Supervision” means the on-site provision of management, direction, oversight and review of tasks assigned to personnel.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Permit Holder Responsibilities."> <text>The permit holder shall:</text> <paragraph num="A."> <text>Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services;</text> </paragraph> <paragraph num="B."> <text>Ensure that an annual review of the policy and procedure manual is performed by a qualified clinician or clinicians to assure that the policies and procedures meet the current standards of practice and regulatory requirements;</text> </paragraph> <paragraph num="C."> <text>Ensure that there is a process to verify the name, address, and contact information of the licensed authorized prescriber of record before initiation of therapy;</text> </paragraph> <paragraph num="D."> <text>Establish and maintain a training program which includes, but is not limited to, the requirements set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="E."> <text>If the infusion pharmacy is performing sterile compounding, ensure compliance with COMAR 10.34.19;</text> </paragraph> <paragraph num="F."> <text>If the infusion pharmacy outsources sterile compounding to another pharmacy, confirm that the secondary pharmacy is appropriately licensed and in compliance with COMAR 10.34.04 and COMAR 10.34.19;</text> </paragraph> <paragraph num="G."> <text>Assign a supervising pharmacist to provide oversight of the facility and operations as specified in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="H."> <text>Ensure adequate supervision to unlicensed personnel;</text> </paragraph> <paragraph num="I."> <text>Limit access to the infusion pharmacy area to authorized personnel;</text> </paragraph> <paragraph num="J."> <text>Secure the facility and patient records in compliance with federal and State laws and regulations; and</text> </paragraph> <paragraph num="K."> <text>Develop and implement a written performance improvement program as set forth in Regulation .08 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Supervising Pharmacist Responsibilities."> <text>The supervising pharmacist or the supervising pharmacist's designee shall ensure compliance with:</text> <paragraph num="A."> <text>State and federal regulations;</text> </paragraph> <paragraph num="B."> <text>Infusion pharmacy practice standards:</text> <paragraph num="(1)"> <text>As set forth in this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>As established by nationally recognized professional organizations and accrediting bodies as appropriate;</text> </paragraph> </paragraph> <paragraph num="C."> <text>The infusion pharmacy’s policies and procedures manual;</text> </paragraph> <paragraph num="D."> <text>An established training program; and</text> </paragraph> <paragraph num="E."> <text>An established performance improvement program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Pharmacist Responsibilities."> <paragraph num="A."> <text>A pharmacist in an infusion pharmacy shall adhere to the policies and procedures set forth in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A pharmacist shall:</text> <paragraph num="(1)"> <text>Provide infusion therapy services in accordance with:</text> <paragraph num="(a)"> <text>Orders issued by a licensed authorized prescriber of record; and</text> </paragraph> <paragraph num="(b)"> <text>Where applicable, protocols issued by a licensed authorized prescriber of record.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Perform and document initial and ongoing assessments of the appropriateness of infusion therapy using the following information:</text> <paragraph num="(a)"> <text>Patient demographics including:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Telephone number;</text> </paragraph> <paragraph num="(iv)"> <text>Gender; and</text> </paragraph> <paragraph num="(v)"> <text>Date of birth;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Emergency contact information;</text> </paragraph> <paragraph num="(c)"> <text>Diagnoses, including:</text> <paragraph num="(i)"> <text>Diagnosis being treated; and</text> </paragraph> <paragraph num="(ii)"> <text>Concurrent conditions, including pregnancy and lactation status if applicable;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Medical history;</text> </paragraph> <paragraph num="(e)"> <text>Allergies;</text> </paragraph> <paragraph num="(f)"> <text>If applicable, height;</text> </paragraph> <paragraph num="(g)"> <text>Weight;</text> </paragraph> <paragraph num="(h)"> <text>Parenteral medication orders, including length of therapy;</text> </paragraph> <paragraph num="(i)"> <text>Parenteral infusion access device:</text> <paragraph num="(i)"> <text>Location;</text> </paragraph> <paragraph num="(ii)"> <text>Type; and</text> </paragraph> <paragraph num="(iii)"> <text>If available, date of placement;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Ongoing medication profile review and reconciliation at end of therapy;</text> </paragraph> <paragraph num="(k)"> <text>First dose status;</text> </paragraph> <paragraph num="(l)"> <text>Caregiver information including, but not limited to:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Phone number; and</text> </paragraph> <paragraph num="(iv)"> <text>Relationship to patient;</text> </paragraph> </paragraph> <paragraph num="(m)"> <text>If applicable, contact information for other agencies or individuals involved in the patient’s home care;</text> </paragraph> <paragraph num="(n)"> <text>Documented applicable medical and social factors and functional limitations which may affect infusion therapy including but not limited to:</text> <paragraph num="(i)"> <text>Language;</text> </paragraph> <paragraph num="(ii)"> <text>Sight;</text> </paragraph> <paragraph num="(iii)"> <text>Hearing;</text> </paragraph> <paragraph num="(iv)"> <text>History of IV drug abuse;</text> </paragraph> <paragraph num="(v)"> <text>History of drug or alcohol abuse; or</text> </paragraph> <paragraph num="(vi)"> <text>Other physical or mental limitations; and</text> </paragraph> </paragraph> <paragraph num="(o)"> <text>If applicable to therapy, baseline labs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Create a patient care plan specific to the patient’s:</text> <paragraph num="(a)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Prescribed therapy; and</text> </paragraph> <paragraph num="(c)"> <text>Concurrent conditions;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When compounding sterile preparations, comply with COMAR 10.34.19;</text> </paragraph> <paragraph num="(5)"> <text>If sterile compounding is outsourced, comply with COMAR 10.34.04;</text> </paragraph> <paragraph num="(6)"> <text>As applicable, retrieve and assess lab values and other monitoring parameters;</text> </paragraph> <paragraph num="(7)"> <text>Document in the patient chart:</text> <paragraph num="(a)"> <text>New prescription orders;</text> </paragraph> <paragraph num="(b)"> <text>Changes in prescription orders;</text> </paragraph> <paragraph num="(c)"> <text>Information obtained from the patient or caregiver; and</text> </paragraph> <paragraph num="(d)"> <text>Other necessary information obtained from the:</text> <paragraph num="(i)"> <text>Patient;</text> </paragraph> <paragraph num="(ii)"> <text>Caregiver;</text> </paragraph> <paragraph num="(iii)"> <text>Infusion nurse;</text> </paragraph> <paragraph num="(iv)"> <text>Licensed authorized prescriber of record; or</text> </paragraph> <paragraph num="(v)"> <text>Other sources relevant to patient care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Verify prescription label accuracy;</text> </paragraph> <paragraph num="(9)"> <text>Communicate as appropriate, throughout the patient’s therapy with the:</text> <paragraph num="(a)"> <text>Licensed authorized prescriber of record or agent of the licensed authorized prescriber of record;</text> </paragraph> <paragraph num="(b)"> <text>Patient’s infusion nurse;</text> </paragraph> <paragraph num="(c)"> <text>Patient; and</text> </paragraph> <paragraph num="(d)"> <text>Caregiver; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Review therapy-specific considerations such as pain and nutrition status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Support Personnel."> <paragraph num="A."> <text>Pharmacy Technicians.</text> <paragraph num="(1)"> <text>A pharmacist working in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in accordance with COMAR 10.34.34.</text> </paragraph> <paragraph num="(2)"> <text>A pharmacy technician working in an infusion pharmacy may not perform delegated pharmacy acts as set forth in COMAR 10.34.34.03.</text> </paragraph> <paragraph num="(3)"> <text>A pharmacy technician working in an infusion pharmacy shall:</text> <paragraph num="(a)"> <text>Communicate immediately to the pharmacist reported changes in:</text> <paragraph num="(i)"> <text>Patient condition;</text> </paragraph> <paragraph num="(ii)"> <text>Patient medication list; and</text> </paragraph> <paragraph num="(iii)"> <text>Allergies; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Obtain pharmacist approval before processing refills.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A pharmacy technician working in an infusion pharmacy may not:</text> <paragraph num="(a)"> <text>Except as provided in COMAR 10.34.34, accept or transcribe a new or change verbal order from an licensed authorized prescriber of record or the licensed authorized prescriber of record’s agent;</text> </paragraph> <paragraph num="(b)"> <text>Perform the clinical assessment of a patient;</text> </paragraph> <paragraph num="(c)"> <text>Communicate clinical matters except as required in §A(3)(a) of this regulations;</text> </paragraph> <paragraph num="(d)"> <text>Provide therapy-related direction to a patient or caregiver; and</text> </paragraph> <paragraph num="(e)"> <text>Create a patient care plan specific to a patient’s therapy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Unlicensed Personnel.</text> <paragraph num="(1)"> <text>Unlicensed personnel working in an infusion pharmacy under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in accordance with COMAR 10.34.21.</text> </paragraph> <paragraph num="(2)"> <text>Unlicensed personnel shall be appropriately trained to perform the following tasks, as applicable, including but not limited to:</text> <paragraph num="(a)"> <text>Schedule delivery dates based on;</text> <paragraph num="(i)"> <text>Patient supply needs;</text> </paragraph> <paragraph num="(ii)"> <text>Patient or caregiver availability; and</text> </paragraph> <paragraph num="(iii)"> <text>If applicable, geographic delivery zones;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Create delivery tickets;</text> </paragraph> <paragraph num="(c)"> <text>Communicate with the infusion nurse or pharmacist concerning supply needs and problems; and</text> </paragraph> <paragraph num="(d)"> <text>Clean, test, and maintain patient-use equipment.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Unlicensed personnel working in an infusion pharmacy shall refer clinical questions or concerns reported by patients or caregivers immediately to the pharmacist.</text> </paragraph> <paragraph num="(4)"> <text>Unlicensed personnel may not perform delegated pharmacy acts.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Minimum Requirements for Policies and Procedures."> <text>The policies and procedures shall:</text> <paragraph num="A."> <text>Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and</text> </paragraph> <paragraph num="B."> <text>Address:</text> <paragraph num="(1)"> <text>Personnel:</text> <paragraph num="(a)"> <text>Training and Orientation;</text> </paragraph> <paragraph num="(b)"> <text>Duties; and</text> </paragraph> <paragraph num="(c)"> <text>Qualifications;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Security of the facility;</text> </paragraph> <paragraph num="(3)"> <text>Standards of patient care;</text> </paragraph> <paragraph num="(4)"> <text>Infection control;</text> </paragraph> <paragraph num="(5)"> <text>Initial and ongoing home safety assessments;</text> </paragraph> <paragraph num="(6)"> <text>The provision of patient or caregiver education including, but not limited to:</text> <paragraph num="(a)"> <text>Drug and therapy administration-specific information and precautions;</text> </paragraph> <paragraph num="(b)"> <text>Reporting adverse drug reactions;</text> </paragraph> <paragraph num="(c)"> <text>Reporting side effects;</text> </paragraph> <paragraph num="(d)"> <text>Infusion pharmacy contact information;</text> </paragraph> <paragraph num="(e)"> <text>Emergency measures related to:</text> <paragraph num="(i)"> <text>Changes in patient condition requiring medical intervention; and</text> </paragraph> <paragraph num="(ii)"> <text>Events which may delay or prevent delivery of pharmaceuticals or nursing care; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Equipment use and safety.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Patient care operations, including but not limited to:</text> <paragraph num="(a)"> <text>If applicable, pharmacist checking procedures related to order entry and compounding accuracy;</text> </paragraph> <paragraph num="(b)"> <text>Therapy-specific monitoring parameters for:</text> <paragraph num="(i)"> <text>Laboratory testing;</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate frequency of testing; and</text> </paragraph> <paragraph num="(iii)"> <text>Patient follow-up; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Pump, or other patient-use equipment, between-patient cleaning, testing, and preventive maintenance, which include specific:</text> <paragraph num="(i)"> <text>Procedures and documentation of cleaning, testing and preventive maintenance for patient equipment according to manufacturer’s guidelines; and</text> </paragraph> <paragraph num="(ii)"> <text>Frequencies for all equipment maintenance activities;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Delivery arrangements;</text> </paragraph> <paragraph num="(9)"> <text>Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164; and</text> </paragraph> <paragraph num="(10)"> <text>Availability of a pharmacist on call after-hours to respond to:</text> <paragraph num="(a)"> <text>Pharmacy related patient or caregiver inquiries; and</text> </paragraph> <paragraph num="(b)"> <text>Medication or supply needs.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Training Requirements."> <paragraph num="A."> <text>Personnel shall be trained in the following areas where appropriate:</text> <paragraph num="(1)"> <text>Patient rights and responsibilities;</text> </paragraph> <paragraph num="(2)"> <text>Patient safety;</text> </paragraph> <paragraph num="(3)"> <text>Performance improvement program;</text> </paragraph> <paragraph num="(4)"> <text>Universal precautions which are incorporated by reference in COMAR 10.06.01.01-1;</text> </paragraph> <paragraph num="(5)"> <text>Warehouse and equipment orientation;</text> </paragraph> <paragraph num="(6)"> <text>Waste management;</text> </paragraph> <paragraph num="(7)"> <text>Handling hazardous substances;</text> </paragraph> <paragraph num="(8)"> <text>Policies and procedures;</text> </paragraph> <paragraph num="(9)"> <text>Recognizing signs of patient abuse and neglect;</text> </paragraph> <paragraph num="(10)"> <text>Recognizing signs of IV drug abuse;</text> </paragraph> <paragraph num="(11)"> <text>Customer service and cultural sensitivity training;</text> </paragraph> <paragraph num="(12)"> <text>Emergency policies and procedures which support the continuum of patient care during natural or manmade disasters; and</text> </paragraph> <paragraph num="(13)"> <text>Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A pharmacist shall be trained and evaluated in the following areas, including but not limited to:</text> <paragraph num="(1)"> <text>Clinical management of therapies and disease states managed by the infusion pharmacy services, including but not limited to:</text> <paragraph num="(a)"> <text>Specific dosing and monitoring protocols;</text> </paragraph> <paragraph num="(b)"> <text>Care planning;</text> </paragraph> <paragraph num="(c)"> <text>Lab value ranges; and</text> </paragraph> <paragraph num="(d)"> <text>Side effects;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pump use and programming;</text> </paragraph> <paragraph num="(3)"> <text>Parenteral infusion access devices and therapy-specific appropriateness by device;</text> </paragraph> <paragraph num="(4)"> <text>Supplies by therapy and device;</text> </paragraph> <paragraph num="(5)"> <text>Accurate set-up of compounding worksheet instructions;</text> </paragraph> <paragraph num="(6)"> <text>Pharmacist functions on computer systems;</text> </paragraph> <paragraph num="(7)"> <text>Documentation;</text> </paragraph> <paragraph num="(8)"> <text>If performing sterile compounding, COMAR 10.34.19;</text> </paragraph> <paragraph num="(9)"> <text>Medication storage;</text> </paragraph> <paragraph num="(10)"> <text>IV compatibility and stability;</text> </paragraph> <paragraph num="(11)"> <text>Calculations to ensure:</text> <paragraph num="(a)"> <text>IV dose appropriateness; and</text> </paragraph> <paragraph num="(b)"> <text>Compounding accuracy, if applicable; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>On-call requirements and procedures for handling after-hours care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy technician obtaining clinical information shall be trained and evaluated in the following areas, including but not limited to:</text> <paragraph num="(1)"> <text>Pharmacy technician functions on computer systems;</text> </paragraph> <paragraph num="(2)"> <text>Parenteral infusion access devices</text> </paragraph> <paragraph num="(3)"> <text>Supplies specific to therapy and device</text> </paragraph> <paragraph num="(4)"> <text>Storage and shipping protocols;</text> </paragraph> <paragraph num="(5)"> <text>Pharmaceutical calculations for IV compounding, if applicable;</text> </paragraph> <paragraph num="(6)"> <text>Patient triage forms — therapy-specific training and communication with the pharmacist as specified in Regulation .05A(3)(a) of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Documentation of:</text> <paragraph num="(a)"> <text>Communication with patients or caregiver; and</text> </paragraph> <paragraph num="(b)"> <text>Delivery scheduling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Unlicensed personnel shall be trained and evaluated in the following areas as applicable:</text> <paragraph num="(1)"> <text>Insurance pre-authorization;</text> </paragraph> <paragraph num="(2)"> <text>Billing;</text> </paragraph> <paragraph num="(3)"> <text>Delivery procedures;</text> </paragraph> <paragraph num="(4)"> <text>Supplies;</text> </paragraph> <paragraph num="(5)"> <text>Picking and packing of supplies;</text> </paragraph> <paragraph num="(6)"> <text>Drug storage;</text> </paragraph> <paragraph num="(7)"> <text>Shipping protocols; and</text> </paragraph> <paragraph num="(8)"> <text>Cleaning, testing, and maintenance of patient-use equipment according to manufacturers’ specifications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Performance Improvement Program."> <paragraph num="A."> <text>The performance improvement program shall consist of:</text> <paragraph num="(1)"> <text>A committee which:</text> <paragraph num="(a)"> <text>Consists of representation of personnel and varied areas of job responsibility; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for analysis of data, reporting trends and corrective actions; and</text> </paragraph> <paragraph num="(c)"> <text>Meets at least quarterly;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Quality assurance and performance improvement monitoring parameters;</text> </paragraph> <paragraph num="(3)"> <text>Documentation requirements for:</text> <paragraph num="(a)"> <text>Established monitoring parameters;</text> </paragraph> <paragraph num="(b)"> <text>Trend analyses; and</text> </paragraph> <paragraph num="(c)"> <text>Retention of committee meeting minutes for 3 years;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Documentation of tracking, trending, analyzing, resolving, and developing corrective action plans as appropriate for:</text> <paragraph num="(a)"> <text>Medication errors;</text> </paragraph> <paragraph num="(b)"> <text>Adverse drug reactions; and</text> </paragraph> <paragraph num="(c)"> <text>Equipment malfunctions;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Reporting of adverse events to regulatory and standard-setting bodies as applicable to State and federal regulations;</text> </paragraph> <paragraph num="(6)"> <text>Documentation and resolution of patient care issues involving:</text> <paragraph num="(a)"> <text>Incorrect equipment, supplies, or medications;</text> </paragraph> <paragraph num="(b)"> <text>Delays in delivery of care;</text> </paragraph> <paragraph num="(c)"> <text>Missed doses;</text> </paragraph> <paragraph num="(d)"> <text>Patient infections;</text> </paragraph> <paragraph num="(e)"> <text>Failures in after-hours care; and</text> </paragraph> <paragraph num="(f)"> <text>Patient, caregiver, or health care provider complaints;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Documentation of patient outcomes;</text> </paragraph> <paragraph num="(8)"> <text>Recall management;</text> </paragraph> <paragraph num="(9)"> <text>Patient compliance monitoring; and</text> </paragraph> <paragraph num="(10)"> <text>Staff training and competency compliance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The permit holder shall review the performance improvement program at a minimum of every 3 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Discontinuation of Infusion Therapy."> <paragraph num="A."> <text>If not addressed in the initial order, the infusion pharmacy shall verify an end of therapy order.</text> </paragraph> <paragraph num="B."> <text>The infusion pharmacist shall:</text> <paragraph num="(1)"> <text>Communicate with the licensed authorized prescriber of record or agent of the prescriber of record to verify:</text> <paragraph num="(a)"> <text>An end of therapy order, if not addressed in the initial order; and</text> </paragraph> <paragraph num="(b)"> <text>Parenteral infusion access device disposition, including orders for removal or line maintenance; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Forward the most current medication list to:</text> <paragraph num="(a)"> <text>The licensed authorized prescriber of record; and</text> </paragraph> <paragraph num="(b)"> <text>To the patient or caregiver.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If appropriate, the infusion pharmacy shall arrange with the patient or caregiver for pick-up of medical equipment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reference Materials."> <paragraph num="A."> <text>An infusion pharmacy shall maintain an adequate reference library to enable it to prepare and dispense infusion therapy properly.</text> </paragraph> <paragraph num="B."> <text>In addition to the requirements of COMAR 10.34.07.03, an infusion pharmacy’s reference library shall include:</text> <paragraph num="(1)"> <text>Material Safety Data Sheets (MSDSs);</text> </paragraph> <paragraph num="(2)"> <text>IV compatibility references;</text> </paragraph> <paragraph num="(3)"> <text>Stability and extended stability references;</text> </paragraph> <paragraph num="(4)"> <text>Websites and electronic references authored by established medical publishers recognized within the field of infusion pharmacy practice as a supplement to its printed library;</text> </paragraph> <paragraph num="(5)"> <text>Pediatric dosing reference, if applicable; and</text> </paragraph> <paragraph num="(6)"> <text>Appropriate clinical references for the population served.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §12-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 1, 2012 (38:23 Md. R. 1421)</annotation> </annotations> </chapter> <chapter num="36" heading="Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to pharmacies and licensed pharmacists serving assisted living programs or group homes as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for assisted living programs or group homes.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Assisted Living Program.</text> <paragraph num="(a)"> <text>“Assisted living program” means a residential or facility-based program that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services 24 hours a day, 7 days a week, to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals.</text> </paragraph> <paragraph num="(b)"> <text>“Assisted living program” does not include:</text> <paragraph num="(i)"> <text>A nursing home or comprehensive care facility, as defined under Health-General Article, §19-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iv)"> <text>A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(v)"> <text>Services provided by family members;</text> </paragraph> <paragraph num="(vi)"> <text>Services provided by a licensed residential service agency or licensed home health agency in an individual's own home; or</text> </paragraph> <paragraph num="(vii)"> <text>A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Article 88A, §140, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Chart order” means a lawful order entered on the chart or a medical record of a resident of an assisted living program or group home by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device.</text> </paragraph> <paragraph num="(3)"> <text>“Group home” means a residence owned, leased, or operated by a licensed group home provider that:</text> <paragraph num="(a)"> <text>Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements;</text> </paragraph> <paragraph num="(b)"> <text>Admits at least two, but not more than eight individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Provides 10 or more hours of supervision per week.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Interim box” means a tamper evident container or an electronic system holding minimal quantities of medications:</text> <paragraph num="(a)"> <text>Agreed upon by the appropriate committee of the assisted living program; and</text> </paragraph> <paragraph num="(b)"> <text>Intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Licensed pharmacist” means a pharmacist who is licensed by the Board to practice pharmacy.</text> </paragraph> <paragraph num="(6)"> <text>“Packaging” means the process by which a medication is:</text> <paragraph num="(a)"> <text>Removed from a:</text> <paragraph num="(i)"> <text>Non-patient specific manufacturer’s original container; or</text> </paragraph> <paragraph num="(ii)"> <text>Patient specific container directly received from another pharmacy licensed in Maryland or operated by the government of the United States provided that the manufacturer’s name is present on the container;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Placed into a new container by a licensed pharmacist or registered pharmacy technician under the direct supervision of a pharmacist; and</text> </paragraph> <paragraph num="(c)"> <text>Packaged as further defined in Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Pharmaceutical services” means the care within practice standards, laws, regulations, and guidelines which is afforded by a licensed pharmacist to the residents of an assisted living program or group home.</text> </paragraph> <paragraph num="(8)"> <text>“Pharmacy area” means that portion of the licensed pharmacy where over-the-counter medications and other products requiring a prescription by federal or State law are stored and where the prescriptions are compounded or prepared.</text> </paragraph> <paragraph num="(9)"> <text>“Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text> <paragraph num="(a)"> <text>Licensed to engage in the practice of pharmacy in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Knowledgeable in, and thoroughly familiar with, the specialized functions of an assisted living program's or group home's pharmaceutical services; and</text> </paragraph> <paragraph num="(c)"> <text>Responsible for and in full and actual charge of the pharmacy and its personnel.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Responsible pharmacist” means a pharmacist who is:</text> <paragraph num="(a)"> <text>Licensed to engage in the practice of pharmacy in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Knowledgeable in, and thoroughly familiar with, the specialized functions of an assisted living program’s or group home’s pharmaceutical services; and</text> </paragraph> <paragraph num="(c)"> <text>Responsible for and in full and actual charge of the pharmacy and its personnel.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Verbal order” means a directive that is orally communicated to a licensed pharmacist to accept a prescription order by a person who is authorized to communicate a prescription.</text> </paragraph> <paragraph num="(12)"> <text>“Written order” means a directive that is directly written by an authorized prescriber or a transcription of an order from an authorized prescriber by a person authorized to transcribe an order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Policies and Procedures."> <text>The permit holder shall establish and operate under a policies and procedures manual which:</text> <paragraph num="A."> <text>Complies with this chapter;</text> </paragraph> <paragraph num="B."> <text>Defines the scope and method of pharmacy services provided to the residents of the assisted living program or group home;</text> </paragraph> <paragraph num="C."> <text>Determines under what circumstances personnel may have access to the pharmacy area;</text> </paragraph> <paragraph num="D."> <text>Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;</text> </paragraph> <paragraph num="E."> <text>Includes:</text> <paragraph num="(1)"> <text>Labeling requirements and distribution methods for medication provided in a single container, slot, blister package, or other method of delivering an entire single dosing unit; and</text> </paragraph> <paragraph num="(2)"> <text>The conditions in which an interim box may be replenished or prepared, delivered, and stored by the assisted living program;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Is provided to:</text> <paragraph num="(1)"> <text>The personnel of the pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program;</text> </paragraph> <paragraph num="(3)"> <text>Group home; and</text> </paragraph> <paragraph num="(4)"> <text>Upon request, an agent of the Board; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Is in a form that is:</text> <paragraph num="(1)"> <text>Written or electronic; and</text> </paragraph> <paragraph num="(2)"> <text>Readily retrievable.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Personnel."> <paragraph num="A."> <text>The permit holder shall appoint a responsible pharmacist who shall:</text> <paragraph num="(1)"> <text>Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title;</text> </paragraph> <paragraph num="(2)"> <text>Be responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary;</text> </paragraph> <paragraph num="(3)"> <text>Be responsible for the safe and efficient dispensing, delivery, and control of, and be accountable for, medications and devices dispensed or distributed by the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>Work in cooperation with the other professional staff of the assisted living program or group home in meeting the responsibilities set forth in Regulation .06 of this chapter and in ordering, storing, and accounting for pharmaceutical materials; and</text> </paragraph> <paragraph num="(5)"> <text>Develop a process for the pharmacy to be notified of medications which have been discontinued.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff.</text> <paragraph num="(1)"> <text>The permit holder:</text> <paragraph num="(a)"> <text>May employ registered pharmacy technicians as required to provide pharmaceutical services to the residents of the assisted living program or group home; and</text> </paragraph> <paragraph num="(b)"> <text>Shall provide policies and procedures that specify the duties that may be performed by registered pharmacy technicians under the supervision of a licensed pharmacist and the duties that may be performed only by a licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The permit holder may employ unlicensed personnel to provide operational support as defined in COMAR 10.34.21.02B.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physical Requirements."> <paragraph num="A."> <text>Storage. The permit holder or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to:</text> <paragraph num="(1)"> <text>Sanitation;</text> </paragraph> <paragraph num="(2)"> <text>Temperature;</text> </paragraph> <paragraph num="(3)"> <text>Light;</text> </paragraph> <paragraph num="(4)"> <text>Ventilation;</text> </paragraph> <paragraph num="(5)"> <text>Segregation; and</text> </paragraph> <paragraph num="(6)"> <text>Security.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Equipment and Materials.</text> <paragraph num="(1)"> <text>The permit holder or designee shall ensure that the pharmacy contains as appropriate to the level of services provided:</text> <paragraph num="(a)"> <text>Equipment;</text> </paragraph> <paragraph num="(b)"> <text>Supplies; and</text> </paragraph> <paragraph num="(c)"> <text>Physical facilities for proper compounding, preparation, and dispensing of medications as outlined in COMAR 10.34.19.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The permit holder or designee shall ensure that the pharmacy contains appropriate reference materials to enable personnel to prepare and dispense medications properly as outlined in COMAR 10.34.07.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Security.</text> <paragraph num="(1)"> <text>The permit holder or designee shall ensure that no individual enters the pharmacy area unless a licensed pharmacist is on duty.</text> </paragraph> <paragraph num="(2)"> <text>The permit holder or designee shall ensure compliance with COMAR 10.34.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Medication and Device Distribution and Pharmaceutical Services."> <paragraph num="A."> <text>The responsible pharmacist shall be accountable for, at a minimum:</text> <paragraph num="(1)"> <text>The preparation of medications compounded in the pharmacy as applicable;</text> </paragraph> <paragraph num="(2)"> <text>The proper preparation, storage, and distribution of compounded sterile preparations according to COMAR 10.34.19 to the extent that the functions are performed at the pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>The packaging and labeling of medications;</text> </paragraph> <paragraph num="(4)"> <text>Records of transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for pharmaceuticals;</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to §A of this regulation, the responsible pharmacist may:</text> <paragraph num="(1)"> <text>Participate in those aspects of the assisted living program’s or group home’s quality assurance improvement program, if such program exists, which relate to pharmaceutical care and effectiveness; and</text> </paragraph> <paragraph num="(2)"> <text>Implement the policies and decisions of the appropriate committee or committees of the assisted living program or group home related to these regulations and to other regulations of the assisted living program or group home.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Medication Packaging."> <paragraph num="A."> <text>A licensed pharmacist shall verify the:</text> <paragraph num="(1)"> <text>Selection of medication to be packaged; and</text> </paragraph> <paragraph num="(2)"> <text>Completed packaging of medication performed by registered pharmacy technicians for the following:</text> <paragraph num="(a)"> <text>Accuracy;</text> </paragraph> <paragraph num="(b)"> <text>Completeness;</text> </paragraph> <paragraph num="(c)"> <text>Appropriateness; and</text> </paragraph> <paragraph num="(d)"> <text>Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed pharmacist shall ensure that labeling of the medication container includes the:</text> <paragraph num="(1)"> <text>Brand or generic name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>Strength of the medication;</text> </paragraph> <paragraph num="(3)"> <text>Name of the pharmacy; and</text> </paragraph> <paragraph num="(4)"> <text>Expiration date of the medication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless a pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:</text> <paragraph num="(1)"> <text>12 months from the date of packaging;</text> </paragraph> <paragraph num="(2)"> <text>The manufacturer's or distributor's listed expiration date; or</text> </paragraph> <paragraph num="(3)"> <text>The maximum time period allowed for the specific packaging used for the medication.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the:</text> <paragraph num="(1)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(2)"> <text>Strength;</text> </paragraph> <paragraph num="(3)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(4)"> <text>Lot number assigned by the pharmacy;</text> </paragraph> <paragraph num="(5)"> <text>Lot number assigned by the distributor or manufacturer;</text> </paragraph> <paragraph num="(6)"> <text>Quantity packaged;</text> </paragraph> <paragraph num="(7)"> <text>Expiration date as defined in §C of this regulation;</text> </paragraph> <paragraph num="(8)"> <text>Manufacturer's expiration date;</text> </paragraph> <paragraph num="(9)"> <text>Date of packaging;</text> </paragraph> <paragraph num="(10)"> <text>Name of pharmacy technician packaging; and</text> </paragraph> <paragraph num="(11)"> <text>Name and initials of verifying licensed pharmacist.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Packaged from Another Pharmacy. A licensed pharmacist may package medication received directly from another pharmacy licensed in Maryland or operated by the government of the United States provided that:</text> <paragraph num="(1)"> <text>A licensed pharmacist determines that the medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the time it was dispensed by the original pharmacy and received by the packaging pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>A licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging;</text> </paragraph> <paragraph num="(3)"> <text>The manufacturer’s name is present on the container received from the other pharmacy; and</text> </paragraph> <paragraph num="(4)"> <text>A licensed pharmacist maintains a master log that includes the following information:</text> <paragraph num="(a)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(b)"> <text>Lot number assigned by the packaging pharmacy;</text> </paragraph> <paragraph num="(c)"> <text>Strength;</text> </paragraph> <paragraph num="(d)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(e)"> <text>Name, address, and telephone number of the original dispensing pharmacy;</text> </paragraph> <paragraph num="(f)"> <text>Prescription number from the original dispensing pharmacy;</text> </paragraph> <paragraph num="(g)"> <text>Quantity packaged;</text> </paragraph> <paragraph num="(h)"> <text>Expiration date as assigned by the original dispensing pharmacy;</text> </paragraph> <paragraph num="(i)"> <text>Date of packaging;</text> </paragraph> <paragraph num="(j)"> <text>Name of pharmacy technician packaging;</text> </paragraph> <paragraph num="(k)"> <text>Name and initials of verifying licensed pharmacist; and</text> </paragraph> <paragraph num="(l)"> <text>Name of the resident.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Labeling of Resident Medications."> <paragraph num="A."> <text>A licensed pharmacist shall ensure that medications dispensed by the pharmacy and intended for use within an assisted living program or group home are dispensed in appropriate containers and are labeled with the:</text> <paragraph num="(1)"> <text>Name and address of the pharmacy;</text> </paragraph> <paragraph num="(2)"> <text>Date of dispensing;</text> </paragraph> <paragraph num="(3)"> <text>Prescription number assigned by the pharmacy;</text> </paragraph> <paragraph num="(4)"> <text>Name of the resident, patient, or consumer, as appropriate;</text> </paragraph> <paragraph num="(5)"> <text>Name, quantity, and strength of the drug;</text> </paragraph> <paragraph num="(6)"> <text>Name of the prescriber;</text> </paragraph> <paragraph num="(7)"> <text>Expiration date of the drug;</text> </paragraph> <paragraph num="(8)"> <text>Required precautionary information regarding controlled substances;</text> </paragraph> <paragraph num="(9)"> <text>Directions for use as set forth in the:</text> <paragraph num="(a)"> <text>Medication administration record; and</text> </paragraph> <paragraph num="(b)"> <text>Prescriber’s orders; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Further cautionary information as may be required or necessary for proper use of the medication.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed pharmacist shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package, are labeled with at least the following:</text> <paragraph num="(1)"> <text>Drug name;</text> </paragraph> <paragraph num="(2)"> <text>Drug strength;</text> </paragraph> <paragraph num="(3)"> <text>Name of manufacturer;</text> </paragraph> <paragraph num="(4)"> <text>Name of the resident, patient or consumer, as appropriate;</text> </paragraph> <paragraph num="(5)"> <text>Lot number, unless prepared extemporaneously;</text> </paragraph> <paragraph num="(6)"> <text>Directions for use as set forth in the:</text> <paragraph num="(a)"> <text>Medication administration record; or</text> </paragraph> <paragraph num="(b)"> <text>Prescriber’s orders; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Expiration date.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Drug Control and Accountability."> <paragraph num="A."> <text>Medications may be accepted for return if:</text> <paragraph num="(1)"> <text>The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device;</text> </paragraph> <paragraph num="(2)"> <text>A licensed pharmacist determines that procedures are in place that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and</text> </paragraph> <paragraph num="(3)"> <text>The permit holder otherwise complies with COMAR 10.34.10.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Discontinued Medications — Controlled Dangerous Substances.</text> <paragraph num="(1)"> <text>Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the resident.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A compounded sterile preparation may not be returned to the inventory of a pharmacy.</text> </paragraph> <paragraph num="D."> <text>Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.</text> </paragraph> <paragraph num="E."> <text>Interim Box. An interim box may be provided to an assisted living program by a permit holder if:</text> <paragraph num="(1)"> <text>A licensed nurse is present on site 24 hours a day, 7 days a week;</text> </paragraph> <paragraph num="(2)"> <text>The assisted living program is compliant with the pharmacy’s policies and procedures regarding usage of the interim box under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>The contents of the interim box are part of the pharmacy inventory until administered.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Prescriber Orders.</text> <paragraph num="(1)"> <text>A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber.</text> </paragraph> <paragraph num="(2)"> <text>A chart order shall be considered a prescription drug order provided that the prescription drug order contains:</text> <paragraph num="(a)"> <text>The full name of the resident, patient, or consumer, as appropriate;</text> </paragraph> <paragraph num="(b)"> <text>The date of issuance;</text> </paragraph> <paragraph num="(c)"> <text>The name, strength, and dosage form of the drug prescribed;</text> </paragraph> <paragraph num="(d)"> <text>The name, type, and specifications of any device;</text> </paragraph> <paragraph num="(e)"> <text>The directions for use;</text> </paragraph> <paragraph num="(f)"> <text>If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber);</text> </paragraph> <paragraph num="(g)"> <text>If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and</text> </paragraph> <paragraph num="(h)"> <text>If verbal, the name of the prescriber and the prescriber’s agent, if applicable.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order.</text> </paragraph> <paragraph num="(4)"> <text>The licensed pharmacist shall document immediately a verbal order in writing.</text> </paragraph> <paragraph num="(5)"> <text>A licensed pharmacist may receive a verbal order:</text> <paragraph num="(a)"> <text>By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or</text> </paragraph> <paragraph num="(b)"> <text>By a voice messaging system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Controlled Dangerous Substances.</text> <paragraph num="(1)"> <text>Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in:</text> <paragraph num="(a)"> <text>Health-General Article, Title 27, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.19.03.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Drug Recalls. The licensed pharmacist shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are:</text> <paragraph num="(a)"> <text>Returned to the pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Sequestered; and</text> </paragraph> <paragraph num="(c)"> <text>Handled as appropriate to the level of the recall.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Adverse Drug Reactions.</text> <paragraph num="(1)"> <text>The licensed pharmacist shall participate on the appropriate committee, if applicable of the assisted living program or group home, to establish procedures to report and record adverse drug reactions.</text> </paragraph> <paragraph num="(2)"> <text>The licensed pharmacist shall ensure the procedures established include, at a minimum:</text> <paragraph num="(a)"> <text>The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the appropriate committee of the assisted living program or group home; and</text> </paragraph> <paragraph num="(b)"> <text>The recording in writing of an adverse reaction on the resident’s chart at the time it is reported.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Records and Reports. The licensed pharmacist shall maintain records and reports as may be required by law, this chapter, and the policies of the assisted living program or group home.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Management."> <paragraph num="A."> <text>The responsible pharmacist, in cooperation with the appropriate committee of the assisted living program, shall develop procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter and COMAR 10.07.14.29 where appropriate.</text> </paragraph> <paragraph num="B."> <text>The responsible pharmacist, in cooperation with the appropriate committee of the group home, if applicable, may develop procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-205, 12-301, 12-401, 12-403, 12-501, and 12-503 — 12-506, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 15, 2013 (40:9 Md. R. 789)</annotation> </annotations> </chapter> <chapter num="37" heading="Pharmacy Permit Holder Requirements — Wholesale Distribution and Nonresident Pharmacy Operations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes requirements for a pharmacy licensed by the Maryland Board of Pharmacy that:</text> <paragraph num="A."> <text>Engages in wholesale distribution; or</text> </paragraph> <paragraph num="B."> <text>Operates as a nonresident pharmacy.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Pharmacies Issued a Waiver Permit."> <paragraph num="A."> <text>A pharmacy that is issued a waiver permit by the Board under Health Occupations Article, §12–403(c), Annotated Code of Maryland, may engage in wholesale distribution, provided that:</text> <paragraph num="(1)"> <text>The waiver pharmacy only engages in wholesale distribution with another pharmacy; and</text> </paragraph> <paragraph num="(2)"> <text>The wholesale distribution business does not exceed 5 percent of the waiver pharmacy’s annual sales.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Record Keeping Requirements. A waiver pharmacy that conducts wholesale distribution as set forth in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Maintain records of the waiver pharmacy’s wholesale distribution separately from its other records; and</text> </paragraph> <paragraph num="(2)"> <text>Make records of wholesale distribution available for inspection by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Wholesale Distribution."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>A full service pharmacy may conduct wholesale distribution provided that the wholesale distribution business does not exceed 5 percent of the full service pharmacy’s annual sales.</text> </paragraph> <paragraph num="(2)"> <text>A full service pharmacy may conduct wholesale distribution:</text> <paragraph num="(a)"> <text>With another pharmacy; or</text> </paragraph> <paragraph num="(b)"> <text>With a wholesale distributor, if the full service pharmacy reports to the Board within a week, on a form approved by the Board, of the full service pharmacy’s wholesale distribution to a wholesale distributor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Recordkeeping Requirements. A full service pharmacy that conducts wholesale distribution as set forth in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Maintain records of wholesale distribution separately from its other records;</text> </paragraph> <paragraph num="(2)"> <text>Maintain records of wholesale distribution to wholesale distributors separately from its records of wholesale distribution to pharmacies; and</text> </paragraph> <paragraph num="(3)"> <text>Make records of wholesale distribution available for inspection by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Nonresident Pharmacy Operations."> <paragraph num="A."> <text>A Maryland licensed pharmacist may not be employed by more than one nonresident pharmacy at a time.</text> </paragraph> <paragraph num="B."> <text>A nonresident pharmacy shall:</text> <paragraph num="(1)"> <text>Hold a pharmacy permit issued by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Have a pharmacist on staff who is:</text> <paragraph num="(a)"> <text>Licensed by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Designated as the pharmacist responsible for providing pharmaceutical services to patients in the State; and</text> </paragraph> <paragraph num="(c)"> <text>Regularly available on-site as needed to meet Maryland patient’s needs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Designate another Maryland licensed pharmacist as the pharmacist on staff within 60 days upon the loss of the current designated pharmacist on staff;</text> </paragraph> <paragraph num="(4)"> <text>Be located and equipped so that the pharmacy may be operated without endangering the public health or safety;</text> </paragraph> <paragraph num="(5)"> <text>Maintain at all times a current reference library that is appropriate to meet the needs of:</text> <paragraph num="(a)"> <text>The practice specialty of that pharmacy; and</text> </paragraph> <paragraph num="(b)"> <text>The consumers the pharmacy serves;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Comply with the regulations adopted by the Board establishing the types of texts required to be included in the reference libraries in each of the various practice specialty pharmacies;</text> </paragraph> <paragraph num="(7)"> <text>Maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary in a pharmacy to:</text> <paragraph num="(a)"> <text>Prepare and dispense prescriptions properly; and</text> </paragraph> <paragraph num="(b)"> <text>Otherwise operate a pharmacy;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Be equipped with the minimum equipment and appliances specified by the Board under this regulation;</text> </paragraph> <paragraph num="(9)"> <text>Be kept in a clean and orderly manner;</text> </paragraph> <paragraph num="(10)"> <text>Store all prescription or nonprescription drugs or devices properly and safely as set forth in COMAR 10.34.22.06;</text> </paragraph> <paragraph num="(11)"> <text>On an annual basis and within 30 days after a change of office, corporate officer, or pharmacist, disclose to the Board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices to persons in this State;</text> </paragraph> <paragraph num="(12)"> <text>Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is located and all requests for information made by the Board pursuant to this regulation;</text> </paragraph> <paragraph num="(13)"> <text>Maintain at all times a valid, unexpired permit to conduct a pharmacy in compliance with the laws of the state in which it is located;</text> </paragraph> <paragraph num="(14)"> <text>Maintain records of prescription drugs or devices dispensed to patients in this State so that the records are readily retrievable;</text> </paragraph> <paragraph num="(15)"> <text>During the pharmacy’s regular hours of operation, but not less than 6 days a week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist or an individual who:</text> <paragraph num="(a)"> <text>Has access to the patient’s prescription records; and</text> </paragraph> <paragraph num="(b)"> <text>Is required to refer patients in the State to the responsible pharmacist licensed in the State, as appropriate;</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Disclose the pharmacy’s toll-free telephone number on a label affixed to each container of drugs or devices;</text> </paragraph> <paragraph num="(17)"> <text>Comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the nonresident pharmacy is located;</text> </paragraph> <paragraph num="(18)"> <text>With regard to a prescription drug that is delivered in this State by the United States Postal Service, a common carrier, or a delivery service and is not personally hand delivered directly to a patient or to the agent of the patient at the residence of the patient or at another location designated by the patient:</text> <paragraph num="(a)"> <text>Provide a general written notice in each shipment of a prescription drug that alerts a consumer that, under certain circumstances, a medication’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and</text> </paragraph> <paragraph num="(b)"> <text>Provide a specific written notice in each shipment of a prescription drug that provides a consumer with a toll-free or local consumer access telephone number accessible during regular hours of operation, which is designed to respond to consumer questions pertaining to medications;</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Provide information regarding the process for resolving incorrectly filled prescriptions in accordance with existing regulations by:</text> <paragraph num="(a)"> <text>Posting a sign that is conspicuously positioned and readable by consumers at the point where prescription drugs are dispensed to consumers; or</text> </paragraph> <paragraph num="(b)"> <text>Including written information regarding the process with each prescription dispensed; and</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>If dispensing compounded sterile preparations to patients in the State, comply with:</text> <paragraph num="(a)"> <text>USP standards; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.34.19.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A nonresident pharmacy may not:</text> <paragraph num="(1)"> <text>Offer pharmaceutical services under any term or condition that tends to interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill;</text> </paragraph> <paragraph num="(2)"> <text>Make any agreement that denies a patient a free choice of pharmacist or pharmacy services;</text> </paragraph> <paragraph num="(3)"> <text>Participate in any activity that is a ground for Board action against:</text> <paragraph num="(a)"> <text>A licensed pharmacist under Health Occupations Article, §12–313, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A registered pharmacy technician under Health Occupations Article, §12–6B–09, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>A registered pharmacy intern under Health Occupations Article, §12–6D–11, Annotated Code of Maryland; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Allow an unauthorized individual to represent that the individual is a pharmacist, a registered pharmacy intern, or registered pharmacy technician.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-205, 12-403, and 12-406, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2014 (41:10 Md. R. 561)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 9, 2017 (44:20 Md. R. 945)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective October 9, 2017 (44:20 Md. R. 945)</annotation> </annotations> </chapter> <chapter num="38" heading="Pharmacy Interns"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to applicants for registration as pharmacy interns and to registered pharmacy interns.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to pharmacy students:</text> <paragraph num="(1)"> <text>In a school of pharmacy sanctioned experiential learning program; or</text> </paragraph> <paragraph num="(2)"> <text>Registered as pharmacy technicians with the Board performing delegated pharmacy acts.</text> </paragraph> </paragraph> <paragraph num="C."> <text>This chapter applies to individuals functioning as a pharmacy intern regardless of whether they are paid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Direct supervision” means that a licensed pharmacist is physically available, notwithstanding appropriate breaks, on-site and in the prescription area or in an area where pharmacy services are provided to supervise the practice of pharmacy and delegated pharmacy acts.</text> </paragraph> <paragraph num="(3)"> <text>“Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy:</text> <paragraph num="(a)"> <text>Accredited by the Accreditation Council for Pharmacy Education; or</text> </paragraph> <paragraph num="(b)"> <text>Having precandidate or candidate status by the Accreditation Council for Pharmacy Education.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist.</text> </paragraph> <paragraph num="(5)"> <text>“Registration” means in this chapter, unless the context requires otherwise, a registration issued by the Board to practice pharmacy under the direct supervision of a licensed pharmacist.</text> </paragraph> <paragraph num="(6)"> <text>“Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibited Pharmacy Acts."> <text>A registered pharmacy intern may not:</text> <paragraph num="A."> <text>Delegate a pharmacy act;</text> </paragraph> <paragraph num="B."> <text>Perform a final verification of a prescription drug or device before dispensing;</text> </paragraph> <paragraph num="C."> <text>Perform any act that has not been authorized by the supervising pharmacist;</text> </paragraph> <paragraph num="D."> <text>Represent themselves as a pharmacist;</text> </paragraph> <paragraph num="E."> <text>Dispense prescription medications when the pharmacist is not in the pharmacy;</text> </paragraph> <paragraph num="F."> <text>Be present in the pharmacy when the pharmacist is not physically available onsite;</text> </paragraph> <paragraph num="G."> <text>Act within the parameters of a therapy management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="H."> <text>Independently compound prescriptions; or</text> </paragraph> <paragraph num="I."> <text>Accept the return of prescription drugs or devices directly from a patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="General Requirements."> <paragraph num="A."> <text>Each registered pharmacy intern shall:</text> <paragraph num="(1)"> <text>Display the pharmacy intern’s registration in the office or place of business in which the pharmacy intern is practicing pharmacy under the direct supervision of a licensed pharmacist; or</text> </paragraph> <paragraph num="(2)"> <text>Have the registration on the pharmacy intern’s person available for viewing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When practicing pharmacy under the direct supervision of a licensed pharmacist, the registered pharmacy intern shall wear identification that conspicuously identifies the registered pharmacy intern as a registered pharmacy intern.</text> </paragraph> <paragraph num="C."> <text>When performing tasks in the prescription area, a pharmacy intern shall maintain proper:</text> <paragraph num="(1)"> <text>Sanitation;</text> </paragraph> <paragraph num="(2)"> <text>Hygiene;</text> </paragraph> <paragraph num="(3)"> <text>Biohazard precautions; and</text> </paragraph> <paragraph num="(4)"> <text>Infection control.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A pharmacy intern, who has obtained a registration as an actively enrolled student, shall immediately notify the Board if the pharmacy intern’s enrollment as a student has been revoked, suspended, terminated, or otherwise discontinued.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Limitation on Supervision."> <text>A licensed pharmacist may not directly supervise more than two registered pharmacy interns at one time.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Registration Requirements."> <paragraph num="A."> <text>An applicant shall be an individual who:</text> <paragraph num="(1)"> <text>Is currently enrolled and has completed 1 year of professional pharmacy education in a doctor of pharmacy program:</text> <paragraph num="(a)"> <text>Accredited by the Accreditation Council for Pharmacy Education; or</text> </paragraph> <paragraph num="(b)"> <text>Having precandidate or candidate status by the Accreditation Council for Pharmacy Education;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has graduated from a doctor of pharmacy program accredited by the Accreditation Council for Pharmacy Education; or</text> </paragraph> <paragraph num="(3)"> <text>Is a graduate of a foreign school of pharmacy who:</text> <paragraph num="(a)"> <text>Has established educational equivalency as approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Has passed an examination of oral English approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant identified in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Submit to the Board a signed completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay a fee as set forth in COMAR 10.34.09;</text> </paragraph> <paragraph num="(3)"> <text>Submit a request for a State Criminal History Records check; and</text> </paragraph> <paragraph num="(4)"> <text>Be of good moral character.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not approve an application until the State Criminal History Records Check is completed.</text> </paragraph> <paragraph num="D."> <text>The Board of Pharmacy shall provide the pharmacy intern with a registration card and pocket identification card upon initial registration and renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal Requirements."> <paragraph num="A."> <text>The pharmacy intern’s registration shall expire on the last day of the birth month following 1 year after initial registration.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C of this regulation, the Board shall send to each registrant, at least 1 month before a registration expires, a renewal notice by first–class mail to the last known address of the registrant.</text> </paragraph> <paragraph num="C."> <text>If requested by a registrant, the Board shall send to the registrant, at least two times within the month before a registration expires, a renewal notice by electronic means to the last known electronic address of the registrant.</text> </paragraph> <paragraph num="D."> <text>If a renewal notice sent by electronic means under §C of this regulation is returned to the Board as undeliverable, the Board shall send to the registrant a renewal notice by first-class mail to the last known address of the registrant.</text> </paragraph> <paragraph num="E."> <text>A renewal notice sent under this regulation shall state:</text> <paragraph num="(1)"> <text>The date on which the current registration expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A registered pharmacy intern who qualifies for registration under Regulation .06A(1) of this chapter may renew the registration one time if the registered pharmacy intern is:</text> <paragraph num="(1)"> <text>Otherwise entitled to be registered as a pharmacy intern;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board a renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Board a renewal fee set by the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A registered pharmacy intern who qualifies for registration under Regulation .06A(2) and (3) of this chapter may not renew the registration.</text> </paragraph> <paragraph num="H."> <text>The registration of a pharmacy intern registered under this chapter is void when the registered pharmacy intern becomes a licensed pharmacist.</text> </paragraph> <paragraph num="I."> <text>The Board shall renew the registration of each pharmacy intern who meets the requirements of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-205, 12-206, 12-301, 12-315 — 12-317, 12-319, 12-320, 12-505, 12-6D-01 — 12-6D-15, and 12-707, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2015 (42:7 Md. R. 569)</annotation> </annotations> </chapter> <chapter num="39" heading="Pharmacist Administration of Self-Administered Drugs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed.</text> </paragraph> <paragraph num="(3)"> <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Pharmacy Experiential Program” means a program under the American Council on Pharmacy Education.</text> </paragraph> <paragraph num="(5)"> <text>Practice Pharmacy.</text> <paragraph num="(a)"> <text>“Practice pharmacy” means to engage in any of the following activities:</text> <paragraph num="(i)"> <text>Providing pharmaceutical care;</text> </paragraph> <paragraph num="(ii)"> <text>Compounding, dispensing, or distributing prescription drugs or devices;</text> </paragraph> <paragraph num="(iii)"> <text>Compounding or dispensing nonprescription drugs or devices;</text> </paragraph> <paragraph num="(iv)"> <text>Monitoring prescriptions and nonprescription drugs or devices;</text> </paragraph> <paragraph num="(v)"> <text>Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices;</text> </paragraph> <paragraph num="(vi)"> <text>Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices;</text> </paragraph> <paragraph num="(vii)"> <text>Acting within the parameters of a therapy management contract, as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(viii)"> <text>Administering vaccinations in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland or self-administered drugs in accordance with Health Occupations Article, §12-509, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(ix)"> <text>Delegating a pharmacy act to a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program;</text> </paragraph> <paragraph num="(x)"> <text>Supervising a delegated pharmacy act performed by a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program; or</text> </paragraph> <paragraph num="(xi)"> <text>Providing drug therapy management in accordance with Health-General Article, §19-713.6, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Practice pharmacy” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12-602, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist.</text> </paragraph> <paragraph num="(7)"> <text>Self-Administered Drug.</text> <paragraph num="(a)"> <text>“Self-administered drug” means a drug that is regularly administered by the patient for whom the drug is prescribed or by an individual who is not otherwise authorized to administer drugs under Health Occupations Article, §12-509, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Self–administered drug” includes:</text> <paragraph num="(i)"> <text>Eye drops;</text> </paragraph> <paragraph num="(ii)"> <text>A drug that is administered by an intramuscular injection or a subcutaneous injection;</text> </paragraph> <paragraph num="(iii)"> <text>Ear drops;</text> </paragraph> <paragraph num="(iv)"> <text>Inhalation therapies;</text> </paragraph> <paragraph num="(v)"> <text>Intranasal therapies; and</text> </paragraph> <paragraph num="(vi)"> <text>Topical therapies.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements to Administer Self-Administered Drugs."> <paragraph num="A."> <text>A licensed pharmacist shall attest that the pharmacist has the appropriate training in administration of self-administered drugs that consists of instruction on:</text> <paragraph num="(1)"> <text>Ear drops;</text> </paragraph> <paragraph num="(2)"> <text>Eye drops;</text> </paragraph> <paragraph num="(3)"> <text>Inhalation therapies;</text> </paragraph> <paragraph num="(4)"> <text>Intramuscular injections;</text> </paragraph> <paragraph num="(5)"> <text>Intranasal therapies;</text> </paragraph> <paragraph num="(6)"> <text>Subcutaneous injections; and</text> </paragraph> <paragraph num="(7)"> <text>Topical therapies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed pharmacist shall possess an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction.</text> </paragraph> <paragraph num="C."> <text>A licensed pharmacist, certified under Health Occupations Article, §12-508, Annotated Code of Maryland, is deemed to have satisfied the training requirements in this chapter.</text> </paragraph> <paragraph num="D."> <text>A licensed pharmacist may administer a self-administered drug in accordance with a prescription.</text> </paragraph> <paragraph num="E."> <text>A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, may administer a self-administered drug under direct supervision of a licensed pharmacist who meets the requirements in §A or B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Record Keeping."> <paragraph num="A."> <text>The pharmacist shall document in the patient record the administration of a self-administered drug that includes the following information:</text> <paragraph num="(1)"> <text>Name of the drug;</text> </paragraph> <paragraph num="(2)"> <text>Dosage administered;</text> </paragraph> <paragraph num="(3)"> <text>Site of administration;</text> </paragraph> <paragraph num="(4)"> <text>Date and time of administration; and</text> </paragraph> <paragraph num="(5)"> <text>Any instructions provided to the patient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The patient record shall be maintained for 5 years, unless otherwise required by law, and be:</text> <paragraph num="(1)"> <text>Readily retrievable; and</text> </paragraph> <paragraph num="(2)"> <text>Made available on the request of the Board.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-101, 12-102(b), and 12-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 9, 2016 (43:9 Md. R. 530)</annotation> </annotations> </chapter> <chapter num="40" heading="Pharmacists Prescribing Contraceptives"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Contraceptives” means contraceptive medications and self-administered contraceptive devices approved by the U.S. Food and Drug Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Pharmacist” means an individual who practices pharmacy under the Health Occupations Article, §12-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Practicing pharmacy” has the same meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Primary care practitioner” means a licensed health care practitioner who:</text> <paragraph num="(a)"> <text>Provides an individual’s primary care services; and</text> </paragraph> <paragraph num="(b)"> <text>Is the primary coordinator of health care services for the individual.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Reproductive health care practitioner” means a licensed health care practitioner who provides an individual’s reproductive health services.</text> </paragraph> <paragraph num="(8)"> <text>“Visit summary” means:</text> <paragraph num="(a)"> <text>A written record of either the contraceptives dispensed or a brief explanation as to why contraceptives were not prescribed;</text> </paragraph> <paragraph num="(b)"> <text>Written information about the importance of seeing the patient’s primary care practitioner or reproductive health care practitioner to obtain recommended tests and screenings; and</text> </paragraph> <paragraph num="(c)"> <text>A copy of the patient’s completed Self-Screening Risk Assessment Questionnaire.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements to Prescribe Contraceptives."> <paragraph num="A."> <text>Board Responsibilities. The Board shall develop and adopt the following items, in consultation with stakeholders to be determined by the Board:</text> <paragraph num="(1)"> <text>A self-screening risk assessment questionnaire that a patient shall complete before a pharmacist may prescribe contraceptives for a patient;</text> </paragraph> <paragraph num="(2)"> <text>A standard procedure contraceptive algorithm which the pharmacist shall use to perform a patient assessment for purposes of determining:</text> <paragraph num="(a)"> <text>Whether to prescribe contraceptives; and</text> </paragraph> <paragraph num="(b)"> <text>Which contraceptive options to prescribe;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A notification form to be submitted by a pharmacist before prescribing contraceptives; and</text> </paragraph> <paragraph num="(4)"> <text>Other forms and procedures for:</text> <paragraph num="(a)"> <text>The prescription of contraceptives; and</text> </paragraph> <paragraph num="(b)"> <text>Referral to a primary care or reproductive health care practitioner for treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notification.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) of this regulation, at least 15 days before prescribing contraceptives, a pharmacist shall submit to the Board a notification form, which includes an attestation of completion of a Board-approved training program.</text> </paragraph> <paragraph num="(2)"> <text>A pharmacist who has undergone training for prescribing contraceptives as part of the pharmacist’s formal educational program:</text> <paragraph num="(a)"> <text>Is exempt from completing a Board-approved training program; and</text> </paragraph> <paragraph num="(b)"> <text>At least 15 days before prescribing contraceptives, shall submit to the Board a notification form, which includes an attestation of the pharmacist’s formal education program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A pharmacist may not prescribe contraceptives until the pharmacist receives a written confirmation from the Board accepting the pharmacist’s notification form.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Pharmacist Responsibilities.</text> <paragraph num="(1)"> <text>For each new patient requesting contraceptive services, and at a minimum of every 12 months for each returning patient, a participating pharmacist shall:</text> <paragraph num="(a)"> <text>Obtain the completed Board-approved self-screening risk assessment questionnaire from the patient; and</text> </paragraph> <paragraph num="(b)"> <text>Utilize and follow the Board-approved standard procedure contraceptive algorithm to:</text> <paragraph num="(i)"> <text>Perform the patient assessment;</text> </paragraph> <paragraph num="(ii)"> <text>Determine whether to prescribe contraceptives; and</text> </paragraph> <paragraph num="(iii)"> <text>Determine which contraceptive options to prescribe.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon completion of all requirements established by the Board and after review of all relevant information, a pharmacist may prescribe contraceptives, if deemed clinically appropriate.</text> </paragraph> <paragraph num="(3)"> <text>If contraceptives are prescribed, the pharmacist shall:</text> <paragraph num="(a)"> <text>Refer the patient:</text> <paragraph num="(i)"> <text>For additional care to their primary care practitioner or reproductive health care practitioner; or</text> </paragraph> <paragraph num="(ii)"> <text>If the patient does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide the patient with a visit summary; and</text> </paragraph> <paragraph num="(c)"> <text>Document the encounter and maintain records pursuant to Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon completion of all requirements established by the Board and after review of all relevant information, if the pharmacist does not prescribe contraceptives, the pharmacist will provide a visit summary to the patient which provides the basis for the decision not to prescribe contraceptives.</text> </paragraph> <paragraph num="(5)"> <text>A pharmacist may not prescribe contraceptives before January 1, 2019.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Training Program Requirements."> <text>At a minimum, a Board-approved training program shall contain the following elements:</text> <paragraph num="A."> <text>An overview of contraceptive medications and self-administered contraceptive devices;</text> </paragraph> <paragraph num="B."> <text>An overview of the self-screening risk assessment questionnaire;</text> </paragraph> <paragraph num="C."> <text>An overview of the standard procedure contraceptive algorithm; and</text> </paragraph> <paragraph num="D."> <text>An overview of the U.S. Medical Eligibility Criteria for Contraceptive Use and other Center for Disease Control guidance on contraception.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Record Keeping."> <text>For a minimum of 5 years, a pharmacy whose pharmacists prescribe contraceptives shall maintain documentation, in electronic or other form, which includes:</text> <paragraph num="A."> <text>The type of contraceptive prescribed, and dosage, if applicable, or the basis for not prescribing a contraceptive;</text> </paragraph> <paragraph num="B."> <text>The name, address, and date of birth of the patient;</text> </paragraph> <paragraph num="C."> <text>The name of the pharmacist who prescribed the contraceptive or determined a contraceptive would not be prescribed;</text> </paragraph> <paragraph num="D."> <text>The date the contraceptive was prescribed or that the patient was advised that a contraceptive would not be prescribed;</text> </paragraph> <paragraph num="E."> <text>A copy of the patient’s visit summary;</text> </paragraph> <paragraph num="F."> <text>A copy of the patient’s self screening risk assessment questionnaire; and</text> </paragraph> <paragraph num="G."> <text>The name and address of the:</text> <paragraph num="(1)"> <text>Patient’s primary care practitioner or reproductive health care practitioner, if provided by the patient; or</text> </paragraph> <paragraph num="(2)"> <text>Family planning provider or licensed clinician who provides reproductive health care services referred by the pharmacist, if the patient does not have a primary care practitioner or reproductive health care practitioner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Continuing Education Requirement."> <text>A pharmacist who prescribes contraceptives in Maryland shall earn 1 hour of Board-approved continuing pharmaceutical education related to contraception before the pharmacist’s license renewal date.</text> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-101, 12-102(b), 12-205(a), and 12-511, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 2, 2018 (45:13 Md. R. 668)</annotation> </annotations> </chapter> <chapter num="41" heading="Administration of a Maintenance Injectable Medication"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Authorized prescriber” means a practitioner licensed and authorized under Health Occupations Article, Annotated Code of Maryland, to prescribe prescription drugs.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Pharmacy.</text> </paragraph> <paragraph num="(3)"> <text>Maintenance Injectable Medication.</text> <paragraph num="(a)"> <text>“Maintenance injectable medication” means a medication that:</text> <paragraph num="(i)"> <text>Is administered by injection other than intravenously;</text> </paragraph> <paragraph num="(ii)"> <text>Except as authorized for a self-administered drug pursuant to Health Occupations Article, §12-509, Annotated Code of Maryland, is not a biological product; and</text> </paragraph> <paragraph num="(iii)"> <text>Treats a chronic need, condition, or disorder.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Maintenance injectable medication” includes, but is not limited to, a medication for:</text> <paragraph num="(i)"> <text>The treatment of a psychiatric disorder;</text> </paragraph> <paragraph num="(ii)"> <text>The treatment of a substance use disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Contraception; and</text> </paragraph> <paragraph num="(iv)"> <text>Vitamins.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Pharmacist” means an individual who practices pharmacy under Health Occupations Article, §12-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Practicing pharmacy” has the meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Primary care practitioner” means a licensed health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements to Administer a Maintenance Injectable Medication — Pharmacist’s Responsibilities."> <paragraph num="A."> <text>Upon completion of all requirements established by the Board in this chapter, and after review of all relevant information, a pharmacist may administer a maintenance injectable medication.</text> </paragraph> <paragraph num="B."> <text>In order to administer a maintenance injectable medication, a pharmacist shall:</text> <paragraph num="(1)"> <text>Utilize and follow the Board-approved procedure set forth in Regulation .07 of this chapter to administer a maintenance injectable medication;</text> </paragraph> <paragraph num="(2)"> <text>Refer a patient for additional care to the patient’s primary care practitioner or the authorized prescriber, if necessary;</text> </paragraph> <paragraph num="(3)"> <text>Provide the patient and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered;</text> </paragraph> <paragraph num="(4)"> <text>Document the encounter and maintain records pursuant to Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Notify the authorized prescriber that the medication was administered to the specific patient and any relevant information about the patient’s condition.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacist shall:</text> <paragraph num="(1)"> <text>Obtain written approval from the patient’s authorized prescriber prior to administering an initial dose of a maintenance injectable medication; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the patient of all fees that the patient is required to pay before administering a maintenance injectable medication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Training Program Requirements."> <paragraph num="A."> <text>Except as provided in §C of this regulation, a pharmacist shall successfully complete a Board-approved training program for the administration of injectable maintenance medications prior to administering injectable maintenance medications.</text> </paragraph> <paragraph num="B."> <text>At a minimum, a Board-approved training program consists of the following elements:</text> <paragraph num="(1)"> <text>Administration of a maintenance injectable medication;</text> </paragraph> <paragraph num="(2)"> <text>Management of the patient populations served by a pharmacist;</text> </paragraph> <paragraph num="(3)"> <text>Knowledge of the specific maintenance injectable medications that a pharmacist may administer; and</text> </paragraph> <paragraph num="(4)"> <text>Current guidelines relating to the specific patient populations served by a pharmacist and the specific maintenance injectable medications that a pharmacist may administer, if applicable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The training program requirement set forth in §A of this regulation is waived for a pharmacist who has undergone the training as part of a formal education program.</text> </paragraph> <paragraph num="D."> <text>A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, who has successfully completed a Board-approved certification course under Health Occupations Article, §12-508, Annotated Code of Maryland, may administer a maintenance injectable medication under the direct supervision of a licensed pharmacist who meets the requirements set forth in Regulation .03 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Record Keeping."> <paragraph num="A."> <text>A pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain the records of a minor patient, including the information listed in §B of this regulation, until the minor patient attains the age of majority plus 3 years or for 5 years after the record was made, whichever is later.</text> </paragraph> <paragraph num="B."> <text>For a minimum of 5 years, except for records related to minors, a pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain documentation, in electronic or other form, including:</text> <paragraph num="(1)"> <text>The type and dose of maintenance injectable medication administered;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and date of birth of the patient;</text> </paragraph> <paragraph num="(3)"> <text>The name of the pharmacist who administered the maintenance injectable medication;</text> </paragraph> <paragraph num="(4)"> <text>The date that the maintenance injectable medication was administered;</text> </paragraph> <paragraph num="(5)"> <text>A copy of the patient’s visit summary, including any pertinent details about the patient’s condition; and</text> </paragraph> <paragraph num="(6)"> <text>The name and address of the authorized prescriber of the maintenance injectable medication.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacist who administers an injectable maintenance medication as an independent provider at a location that is not a pharmacy shall maintain records as required by §§A and B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Patient Information and Consent."> <paragraph num="A."> <text>A pharmacist that administers a maintenance injectable medication shall:</text> <paragraph num="(1)"> <text>Obtain a paper or electronic consent form signed by the patient, or the patient’s legal guardian, that authorizes the pharmacist to administer the maintenance injectable medication;</text> </paragraph> <paragraph num="(2)"> <text>Provide the patient, or the patient’s legal guardian, with a copy of the consent form for future reference upon request;</text> </paragraph> <paragraph num="(3)"> <text>Provide the patient, or the patient’s legal guardian, and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered; and</text> </paragraph> <paragraph num="(4)"> <text>Notify the patient of the need to attend any upcoming appointments the patient has scheduled with the prescriber for additional care.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The administering pharmacist shall:</text> <paragraph num="(1)"> <text>Disclose their credentials on the consent form; and</text> </paragraph> <paragraph num="(2)"> <text>Provide every patient with notification of the fee for service prior to administration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standard Procedures."> <paragraph num="A."> <text>Before a pharmacist administers a maintenance injectable medication, a pharmacist shall have and maintain a written procedure for any maintenance injectable medication that may be administered.</text> </paragraph> <paragraph num="B."> <text>A pharmacist shall administer a maintenance injectable medication in accordance with the written procedure, including:</text> <paragraph num="(1)"> <text>Recording and maintaining the prescription files in accordance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Reviewing and screening for the following:</text> <paragraph num="(a)"> <text>Indications;</text> </paragraph> <paragraph num="(b)"> <text>Precautions;</text> </paragraph> <paragraph num="(c)"> <text>Contraindications; and</text> </paragraph> <paragraph num="(d)"> <text>Allergies;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reviewing the process for handling adverse reactions, including but not limited to:</text> <paragraph num="(a)"> <text>Acute anaphylactic reactions; and</text> </paragraph> <paragraph num="(b)"> <text>Other acute emergencies;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Following injection or administration procedures;</text> </paragraph> <paragraph num="(5)"> <text>Advising the patient of post-administration procedures, including waiting requirements; and</text> </paragraph> <paragraph num="(6)"> <text>Documenting and maintaining a maintenance injectable medication record, including:</text> <paragraph num="(a)"> <text>Patient’s:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Date of birth;</text> </paragraph> <paragraph num="(iii)"> <text>Address;</text> </paragraph> <paragraph num="(iv)"> <text>Consent form;</text> </paragraph> <paragraph num="(v)"> <text>Authorized prescriber; and</text> </paragraph> <paragraph num="(vi)"> <text>Administering pharmacist’s name and license number;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Administration:</text> <paragraph num="(i)"> <text>Date;</text> </paragraph> <paragraph num="(ii)"> <text>Dose;</text> </paragraph> <paragraph num="(iii)"> <text>Site; and</text> </paragraph> <paragraph num="(iv)"> <text>Route;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintenance injectable medication:</text> <paragraph num="(i)"> <text>Name, generic or brand;</text> </paragraph> <paragraph num="(ii)"> <text>Manufacturer;</text> </paragraph> <paragraph num="(iii)"> <text>Lot number; and</text> </paragraph> <paragraph num="(iv)"> <text>Expiration date;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Notification to the authorized prescriber that the patient received a specific maintenance injectable medication; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the prescription is:</text> <paragraph num="(i)"> <text>Not for the patient’s initial dose, if applicable; or</text> </paragraph> <paragraph num="(ii)"> <text>For the patient’s initial dose and the patient’s record contains documented approval from the authorized prescriber.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The pharmacist shall:</text> <paragraph num="(1)"> <text>Sign and date the standard procedure at least annually;</text> </paragraph> <paragraph num="(2)"> <text>Make the standard procedure available for inspection by the Board upon request; and</text> </paragraph> <paragraph num="(3)"> <text>Review and update the standard procedure as necessary.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-Occupations Article, §§12-101(o-1) and 12-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 13, 2022 (49:12 Md. R. 640)</annotation> </annotations> </chapter> <chapter num="42" heading="Pharmacist Prescribing of a Nicotine Replacement Therapy Medication"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Pharmacy.</text> </paragraph> <paragraph num="(2)"> <text>“Nicotine replacement therapy medication” means a nicotine-based treatment, including inhalers, gums, lozenges, nasal sprays, and patches, approved by the United States Food and Drug Administration that assists an individual to cease the use of products that contain nicotine.</text> </paragraph> <paragraph num="(3)"> <text>“Primary care practitioner” means a licensed health care practitioner who:</text> <paragraph num="(a)"> <text>Provides an individual’s primary care services; and</text> </paragraph> <paragraph num="(b)"> <text>Is the primary coordinator of health care services for the individual.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Visit summary” means:</text> <paragraph num="(a)"> <text>A written record of the nicotine replacement therapy medication dispensed;</text> </paragraph> <paragraph num="(b)"> <text>The name and contact information for the prescribing pharmacist; and</text> </paragraph> <paragraph num="(c)"> <text>The information on the importance of regular appointments with the individual’s primary care practitioner.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements to Prescribe and Dispense a Nicotine Replacement Therapy Medication."> <paragraph num="A."> <text>Training Requirements.</text> <paragraph num="(1)"> <text>Prior to prescribing and dispensing a nicotine replacement therapy medication, a pharmacist shall complete a training program developed for the prescribing of a nicotine replacement therapy medication approved by the Board that is:</text> <paragraph num="(a)"> <text>Offered by an accredited school of pharmacy;</text> </paragraph> <paragraph num="(b)"> <text>Offered by an accredited school of medicine; or</text> </paragraph> <paragraph num="(c)"> <text>Accredited by the Accreditation Council for Pharmacy Education.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pharmacist who obtained training to prescribe a nicotine replacement therapy medication as part of their formal education is exempt from completing an additional training program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Standard Procedures. When an individual requests a nicotine replacement therapy medication, a pharmacist shall:</text> <paragraph num="(1)"> <text>Provide the individual with appropriate counseling in the use of the prescribed nicotine replacement therapy medication;</text> </paragraph> <paragraph num="(2)"> <text>Provide the individual with a visit summary;</text> </paragraph> <paragraph num="(3)"> <text>Refer the patient to the individual’s primary care provider for additional care; and</text> </paragraph> <paragraph num="(4)"> <text>Record the prescribing and dispensing of the nicotine replacement therapy medication in any health record maintained for the individual by the pharmacist.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-205 and 12-514, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 14, 2024 (51:20 Md. R. 899)</annotation> </annotations> </chapter> <chapter num="43" heading="Prescription Labeling for Blind, Visually Impaired, and Print Disabled Individuals" reason="Not yet effective" /> </subtitle> <subtitle num="35" heading="Office of the Chief Medical Examiner"> <chapter num="01" heading="Medical Examiner Cases"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Autopsy report” means a written document detailing the medical findings and conclusions of a postmortem examination performed by a medical examiner.</text> </paragraph> <paragraph num="(2)"> <text>“First degree relative” means a surviving spouse, parent, grandparent, sibling, and child of the deceased.</text> </paragraph> <paragraph num="(3)"> <text>“Forensic investigator” means a chief forensic investigator, deputy chief forensic investigator, lead forensic investigator, or forensic investigator who:</text> <paragraph num="(a)"> <text>Is employed under or appointed by the authority of the Maryland Department of Health;</text> </paragraph> <paragraph num="(b)"> <text>Assists those medical examiners in §B(4)(a) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Has education, training, or experience in trauma or death investigation; and</text> </paragraph> <paragraph num="(d)"> <text>Is appointed in accordance with Health-General Article, §5-306, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Medical Examiner.</text> <paragraph num="(a)"> <text>“Medical examiner” means a Chief Medical Examiner, Deputy Chief Medical Examiner, or assistant medical examiner who is a pathologist authorized to carry out the provisions of Health-General Article, §5-308, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Medical examiner” also means a deputy medical examiner who:</text> <paragraph num="(i)"> <text>Assists those examiners in §B(4)(a) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Is a physician; and</text> </paragraph> <paragraph num="(iii)"> <text>Is appointed by the Maryland Department of Health in accordance with Health-General Article, §§5-305 and 5-306, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Medical Examiner Case.</text> <paragraph num="(a)"> <text>“Medical examiner case” means any death which occurs as described in Health-General Article, §5-308(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Medical examiner case” does not mean:</text> <paragraph num="(i)"> <text>A stillbirth or a neonatal death, or accident room or hospital death in which the cause of death has been established by the hospital physician and is due to disease, and free of evidence of criminal or accidental nature;</text> </paragraph> <paragraph num="(ii)"> <text>A case which is dead on arrival at the hospital and the physician who pronounces death has been in previous attendance on the patient; or</text> </paragraph> <paragraph num="(iii)"> <text>A death which occurs in a hospital within 24 hours of admission merely because the death occurred within 24 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Procurement organization” has the meaning stated in Estates and Trusts Article, §4-501, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Report of Medical Examiner Cases to the Police or Sheriff."> <paragraph num="A."> <text>Whenever a physician, funeral director, or other person has knowledge of a death that may fall under the jurisdiction of the Office of the Chief Medical Examiner in accordance with Health-General Article, §5-308(a), Annotated Code of Maryland, the physician, funeral director, or other person having this knowledge shall report it without delay to the police or sheriff law enforcement agency who has jurisdiction in the city or county where the death occurred.</text> </paragraph> <paragraph num="B."> <text>The medical examiner or forensic investigator may, in conjunction with law enforcement or under court authority, investigate any location believed to be associated with the death to gather essential facts to determine cause of death or manner of death.</text> </paragraph> <paragraph num="C."> <text>A health care facility may not refuse the medical examiner access to a body which is the subject of a medical examiner investigation at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Medical Examiner."> <text>Any death in accordance with Health-General Article, §5-308(a), Annotated Code of Maryland, in the State shall be investigated and examined by the medical examiner in the Office of the Chief Medical Examiner in Baltimore, or in any other place as may be approved by the Chief Medical Examiner.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Deaths Due to Fire."> <paragraph num="A."> <text>Fire Fighters and State Fire Marshal Personnel. The medical examiner shall perform an autopsy and complete toxicological examination of any fire fighter or sworn personnel of the State Fire Marshal's Office who dies in the line of duty or whose death appears to have been caused by:</text> <paragraph num="(1)"> <text>Fire;</text> </paragraph> <paragraph num="(2)"> <text>Toxic gases;</text> </paragraph> <paragraph num="(3)"> <text>Toxic fire conditions; or</text> </paragraph> <paragraph num="(4)"> <text>Fire-related circumstances.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Other Fire-Related Deaths. If a death occurs in a fire or is related to a fire, the medical examiner shall thoroughly investigate the circumstances of the death and report the death to the Center for the Study of the Health Effects of Fire in the Office of the Chief Medical Examiner for Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Completion of the Death Certificate."> <paragraph num="A."> <text>When the medical examiner has made a determination of the cause and manner of death, the medical examiner shall complete the death certificate.</text> </paragraph> <paragraph num="B."> <text>On the death certificate the medical examiner shall enter the:</text> <paragraph num="(1)"> <text>Name of the deceased;</text> </paragraph> <paragraph num="(2)"> <text>Cause of death and medical certification;</text> </paragraph> <paragraph num="(3)"> <text>Date and hour of death;</text> </paragraph> <paragraph num="(4)"> <text>Place where death occurred; and</text> </paragraph> <paragraph num="(5)"> <text>Place where the body was found.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Medical Examiner shall record the manner of death under the section of the certificate designated as the medical certification.</text> </paragraph> <paragraph num="D."> <text>If the cause of death has not been established with reasonable medical certainty and further investigation is being conducted, the cause of death is left pending.</text> </paragraph> <paragraph num="E."> <text>If the cause of death has not been established with reasonable medical certainty, and the investigation has been completed, the certificate shall be completed to reflect that the cause of death was “undetermined”, and the manner of death was “undetermined”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Establishing a Hospital Death as a Medical Examiner Case."> <paragraph num="A."> <text>The hospital physician shall be guided by the history and other circumstances in judging whether or not a death is under the jurisdiction of the medical examiner.</text> </paragraph> <paragraph num="B."> <text>Cases that do not fall under medical examiner jurisdiction may not be made such and will not be accepted simply because hospital autopsy permission has been refused or is not available.</text> </paragraph> <paragraph num="C."> <text>Cases that fall under medical examiner jurisdiction may not be autopsied by the hospital pathologist because consent for autopsy has been obtained in accordance with Health-General Article, §5-501, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Hospital Autopsy of Certain Medical Examiner Cases."> <paragraph num="A."> <text>The following types of medical examiner cases may be autopsied by the hospital pathologists with the authorization of the Chief Medical Examiner:</text> <paragraph num="(1)"> <text>Death from acute or chronic alcoholism without manifestation of trauma;</text> </paragraph> <paragraph num="(2)"> <text>Death from accidental burns occurring in the home;</text> </paragraph> <paragraph num="(3)"> <text>Death, or sudden death, associated with a therapeutic procedure;</text> </paragraph> <paragraph num="(4)"> <text>Death following a fracture in an elderly person and resulting from a simple fall in the home.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the cases listed in Sec. A of this regulation, permission from next of kin is not required since these are under the medical examiner's jurisdiction and the hospital pathologist is acting pursuant to this jurisdiction.</text> </paragraph> <paragraph num="C."> <text>The hospital agent shall complete the death certificate, and each death certificate shall be countersigned by the medical examiner.</text> </paragraph> <paragraph num="D."> <text>In non-medical-examiner cases, a hospital shall require proper autopsy permission in accordance with Maryland Autopsy Law, Health-General Article, § 5-501, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="The Hospital Agent."> <paragraph num="A."> <text>Appointment.</text> <paragraph num="(1)"> <text>Each hospital shall appoint a responsible agent, office, or individual with whom the medical examiner can communicate at any hour regarding medical examiner cases in the hospital, after receiving notification of them from the police authority.</text> </paragraph> <paragraph num="(2)"> <text>Each hospital shall notify the medical examiner of the agent so appointed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Responsibilities.</text> <paragraph num="(1)"> <text>Notification of Police. In accordance with Regulation .02 of this chapter, whenever a hospital in Maryland has a medical examiner case, the hospital agent shall report the case to the local law enforcement agency with jurisdiction in that subdivision of the State. The local law enforcement agency so notified shall transmit the information to the medical examiner’s investigator on duty.</text> </paragraph> <paragraph num="(2)"> <text>A health care facility may not refuse the medical examiner access to a body which is the subject of a medical examiner’s case at any time. In order to prevent destruction or alteration of evidence, once death is determined, the hospital shall follow medical examiner guidance as to management of the body of the deceased. The medical examiner shall respond to the location of the body, investigate the case, and arrange for transportation of the body.</text> </paragraph> <paragraph num="(3)"> <text>Preliminary Hospital Reports. The hospital agent designated in accordance with Regulation .08 of this chapter shall submit promptly to the medical examiner, for each medical examiner case, the following information:</text> <paragraph num="(a)"> <text>The name and age, if known, of each decedent;</text> </paragraph> <paragraph num="(b)"> <text>The date and time of admission;</text> </paragraph> <paragraph num="(c)"> <text>Time of death;</text> </paragraph> <paragraph num="(d)"> <text>Diagnosis, if made;</text> </paragraph> <paragraph num="(e)"> <text>Place, date, time, and manner of accident, or violence, if any, and other information that the Medical Examiner may request;</text> </paragraph> <paragraph num="(f)"> <text>Next-of-Kin, if known, as an attempt of a reasonable search effort; and</text> </paragraph> <paragraph num="(g)"> <text>If any evidence is recovered during therapeutic intervention, the Office of the Chief Medical Examiner shall be notified.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Medical Examiner Requests. The hospital agent shall promptly respond to a medical examiner request for records and specimens. Failure to provide requested information within 24 hours will result in a report to the Office of Health Care Quality.</text> </paragraph> <paragraph num="(5)"> <text>If, during a routine autopsy by a hospital pathologist, evidence is encountered which indicates that the death should be under the jurisdiction of the medical examiner:</text> <paragraph num="(a)"> <text>The death then shall become a medical examiner case;</text> </paragraph> <paragraph num="(b)"> <text>The hospital agent immediately shall notify the police or sheriff, who will in turn notify the medical examiner; and</text> </paragraph> <paragraph num="(c)"> <text>The hospital pathologist shall discontinue the autopsy pending the arrival of the medical examiner.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Clinical and Autopsy Reports from Hospitals. Whenever a medical examiner case is autopsied in a hospital, the hospital agent shall submit to the medical examiner, without delay, a clinical summary report, preferably filled out by the physician most familiar with the case, and a provisional anatomical diagnosis, and later a copy of the final autopsy report.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Anesthetic Deaths."> <text>In the case of any anesthetic death occurring in Maryland, the hospital in which the death occurred shall notify immediately, by telephone, the Chief Medical Examiner or a Deputy Chief Medical Examiner, an assistant medical examiner, or the deputy medical examiner of the county in which the death occurred.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Entry to Storage or Autopsy Room at Office of the Chief Medical Examiner."> <text>An individual, other than a member of the staff of the Chief Medical Examiner, may not enter the storage room or the autopsy room while work is being carried on there, except with the permission of the Chief Medical Examiner or the medical examiner performing the work.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Tissue Recovery."> <text>Whenever an authorized organ and tissue procurement organization has informed the Chief Medical Examiner or the Chief Medical Examiner's deputy or assistant medical examiner that there is a need for tissue for research or transplantation, the Chief Medical Examiner shall allow the authorized organ and tissue procurement organization to make a recovery if:</text> <paragraph num="A."> <text>Proper authorization has been provided to the medical examiner;</text> </paragraph> <paragraph num="B."> <text>The body has been tested to determine its suitability for transplantation;</text> </paragraph> <paragraph num="C."> <text>An autopsy is going to be performed and the removal does not interfere with the subsequent investigation or examination; and</text> </paragraph> <paragraph num="D."> <text>The medical examiner does not know of an objection to the autopsy or donation of tissue by the next of kin.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Donation of Internal Organs for Transplantation."> <paragraph num="A."> <text>Whenever there is an immediate need for an internal organ as a transplant, that is, heart, lung, kidney, liver, pancreas, spleen, lymph nodes, or adrenal gland, a medical examiner may provide the organ, if requested by a transplant surgeon, under the following conditions:</text> <paragraph num="(1)"> <text>The medical examiner has jurisdiction over the body of a decedent;</text> </paragraph> <paragraph num="(2)"> <text>The body has been tested to determine its suitability;</text> </paragraph> <paragraph num="(3)"> <text>The hospital representative and treating physician have obtained proper authorization for this decedent;</text> </paragraph> <paragraph num="(4)"> <text>A reasonable, unsuccessful search has been made by the procurement organization as required by Estates and Trusts Article, §4–512(f), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>No objection by the next of kin is known or reasonably foreseen by the medical examiner; and</text> </paragraph> <paragraph num="(6)"> <text>The removal of the organ requested for transplant does not interfere with an investigation or autopsy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Whenever a medical examiner on duty determines that an organ cannot be removed for one of the reasons stated in Sec. A of this regulation, the transplant surgeon may request that this decision be reviewed by the Chief Medical Examiner, a Deputy Chief Medical Examiner, or their designee.</text> </paragraph> <paragraph num="C."> <text>Whenever a decedent is determined to have died by some violent means, the medical examiner may not authorize removal of the requested organs without observation by the medical examiner or the medical examiner's agent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Administrative Review of Correction of Findings and Conclusions."> <paragraph num="A."> <text>Except in a case of a finding of homicide, a person in interest as defined in General Provisions Article, §4-101, Annotated Code of Maryland, may request the Office of the Chief Medical Examiner to correct findings and conclusions on the cause and manner of death recorded on a certificate of death under General Provisions Article, §4-502, Annotated Code of Maryland within 180 days after a medical examiner files those findings and conclusions in accordance with Health-General Article, §5-309(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A person in interest, has the meaning stated in General Provisions Article, §4-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The request to correct the findings and conclusions on a death certificate shall:</text> <paragraph num="(1)"> <text>Be in writing to the Chief Medical Examiner;</text> </paragraph> <paragraph num="(2)"> <text>Describe the requested change precisely; and</text> </paragraph> <paragraph num="(3)"> <text>State the reasons for the change.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Within 60 days after receiving the request in §C of this regulation, the Chief Medical Examiner shall provide the person in interest written notice of the action taken.</text> </paragraph> <paragraph num="E."> <text>If the Chief Medical Examiner denies the request to correct findings and conclusions on the cause of death, the person in interest may appeal the denial in writing within 15 days to the Secretary. The Secretary shall refer the matter within 15 days of receipt to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="F."> <text>An administrative law judge shall conduct a hearing both on the denial and on the establishment of the findings and conclusions on the cause of death.</text> </paragraph> <paragraph num="G."> <text>Upon reviewing the findings of fact submitted by an administrative law judge, the Secretary or the Secretary's designee shall issue an order within 60 days to:</text> <paragraph num="(1)"> <text>Adopt the findings of the administrative law judge; or</text> </paragraph> <paragraph num="(2)"> <text>Reject the findings of the administrative law judge and affirm the findings of the medical examiner.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the Secretary or Secretary's designee rejects the findings of an administrative law judge, the person in interest may appeal that rejection to a circuit court of competent jurisdiction under Maryland law.</text> </paragraph> <paragraph num="I."> <text>If the final decision of the Secretary or the Secretary's designee, or of a court of competent jurisdiction on appeal establishes a different finding or conclusion on the cause or manner of death of a deceased than that recorded on the certificate of death, the medical examiner shall amend the certificate to reflect the different finding or conclusion.</text> </paragraph> <paragraph num="J."> <text>The medical examiner shall send a change letter to the Division of Vital Records to amend the certificate of death, to reflect the final decision of the Secretary or Secretary's designee, or a court of competent jurisdiction.</text> </paragraph> <paragraph num="K."> <text>The final decision of the Secretary or the Secretary's designee, or of a court in an appeal under this regulation, may not give rise to any presumption concerning the application of any provision of or the resolution of any claim concerning a policy of insurance relating to the deceased.</text> </paragraph> <paragraph num="L."> <text>If the findings of the medical examiner are upheld by the Secretary, the appellant is responsible for the costs of the contested case hearing, based on the billing rate established by the Office of Administrative Hearings. Otherwise, the Department is responsible for the costs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Release of Medical Examiner's Records."> <paragraph num="A."> <text>Individual files of the Chief Medical Examiner are confidential medical records protected from disclosure under the provisions of Health-General Article, §4-301, Annotated Code of Maryland, and General Provisions Article, §§4-329 et. seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An exception to these confidential medical records is the official medical examiner's autopsy report. This report is a public record and is generally subject to disclosure under General Provisions Article, §4-329, Annotated Code of Maryland, unless the case is subject to an ongoing investigation, or other appropriate reason for denial of disclosure exists.</text> </paragraph> <paragraph num="C."> <text>Records request by court order or subpoena shall be subject to the fee schedule set forth herein.</text> </paragraph> <paragraph num="D."> <text>Fee Schedule.</text> <paragraph num="(1)"> <text>Autopsy reports may be sent electronically to the requestor. The fees schedule is the same for paper or electronic reports and is as follows:</text> <paragraph num="(a)"> <text>No fee for a first-degree relative, as defined by COMAR 10.35.01.01B; and</text> </paragraph> <paragraph num="(b)"> <text>A fee of $50 for all others may be charged for providing a requested autopsy report.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Requests for other information or material shall be accompanied by a court order or subpoena unless the Custodian of Records determines compelling circumstances exist warranting the release of materials. If releasable, the contents of the file will be copied at a cost of $1 per page with a minimum charge of $25 excluding any item independently listed in §D of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Photographs are copied electronically. There is a $50 processing fee for each digital record, plus $5 per each image copied. X-rays and CT scans are copied electronically. There is a $50 processing fee for each digital record, plus $25 per X-ray.</text> </paragraph> <paragraph num="(4)"> <text>Slides are copied electronically. There is a $50 processing fee for each digital record, plus $20 for each image copied. Slides may be viewed in the Office of the Chief Medical Examiner facility at a rate of $200 for the first hour and $50 for every 15 minute increment thereafter, partial or whole. The reviewer will have access to the medical examiner during the review.</text> </paragraph> <paragraph num="(5)"> <text>A proof of death document may be obtained for $20.</text> </paragraph> <paragraph num="(6)"> <text>If any or all of the items listed in §D of this regulation are requested in digital format, an additional fee of $60 shall apply.</text> </paragraph> <paragraph num="(7)"> <text>These fees do not apply if the releasable documents are viewed only, by appointment, at the OCME, at the discretion of the custodian of records.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual, other than the custodian of the records of the Office of the Chief Medical Examiner or a designee, may not copy or distribute a copy of the official report of the Office of the Chief Medical Examiner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Communicable Disease."> <text>If, during the investigation of a death under the jurisdiction of the Office of the Chief Medical Examiner, a communicable disease is identified, it shall be reported by the medical examiner in writing within 24 hours to the health officer in the appropriate jurisdiction and to the deputy State health official, on the forms supplied by the Maryland Department of Health, in accordance with COMAR 10.06.01.04.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Child Abuse or Neglect, or Both."> <text>A death that is investigated by the Office of the Chief Medical Examiner that is found to be caused by or related to child abuse or neglect shall be reported by a medical examiner orally and in writing to local departments of social services and the local law enforcement agency of the jurisdiction in which the child last resided, in accordance with Family Law Article, §5-704, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Notification of Exposure to Contagious or Infectious Disease."> <text>Whenever it is required that the Office of the Chief Medical Examiner notify a firefighter, emergency medical technician, rescue squad member, law enforcement officer, correctional officer, etc., of exposure to contagious disease or virus, and pursuant to Health-General Article, §18-213, Annotated Code of Maryland, the following procedures shall be followed:</text> <paragraph num="A."> <text>A medical examiner shall review information gathered in the course of the postmortem examination, including testing for contagious disease or viruses;</text> </paragraph> <paragraph num="B."> <text>If evidence of contagious disease or virus, as defined in Health-General Article, §18-213, Annotated Code of Maryland, is identified in the test carried out in the postmortem examination, this information shall be provided by the Office of the Chief Medical Examiner to the officially designated agency representative of the appropriate firefighter, emergency medical technician, rescue squad member, law enforcement officer, correctional officer, etc., with a copy to each of these.</text> </paragraph> <paragraph num="C."> <text>The Office of the Chief Medical Examiner shall verbally notify the agency-designated representative within 48 hours after confirmation of the diagnosis, and subsequently confirm that notice, in writing, and in a manner that protects the confidentiality of the patient; and</text> </paragraph> <paragraph num="D."> <text>The agency representative shall notify the individual believed to have been exposed to the contagious disease or virus.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Deaths in a State-Funded or State-Operated Facility."> <paragraph num="A."> <text>A death in a State-funded or State-operated facility which constitutes a medical examiner's case, as defined in Health-General Article, §5-308, Annotated Code of Maryland, shall be investigated by the Office of the Chief Medical Examiner.</text> </paragraph> <paragraph num="B."> <text>Notification and Investigation. The sheriff, police, or chief law enforcement officer, in the jurisdiction where a death occurs, shall notify the medical examiner whenever a death that constitutes a medical examiner's case occurs in a State-funded or State-operated facility. If the death may have occurred by violence, by suicide, by casualty, suddenly when the person was in apparently good health, not attended by a physician, or in any suspicious or unusual manner, the medical examiner or investigator shall:</text> <paragraph num="(1)"> <text>Respond directly to the administrative head of the facility;</text> </paragraph> <paragraph num="(2)"> <text>Conduct an investigation;</text> </paragraph> <paragraph num="(3)"> <text>Complete the investigation report; and</text> </paragraph> <paragraph num="(4)"> <text>Arrange to have the body sent to the Office of the Chief Medical Examiner for an autopsy, if necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Completion of Investigation Report.</text> <paragraph num="(1)"> <text>A medical examiner or investigator shall document in an investigation report all of the information regarding the death that was:</text> <paragraph num="(a)"> <text>Gathered in the course of the investigation; and</text> </paragraph> <paragraph num="(b)"> <text>Provided by the administrative head of the facility to the sheriff, police, chief law enforcement official, or health officer in the jurisdiction where the death occurred.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A medical examiner or investigator shall append to an investigation report the written report of the death that the administrative head of the facility provided to the sheriff, police, chief law enforcement official, or health officer in the jurisdiction where the death occurred.</text> </paragraph> <paragraph num="(3)"> <text>Required Contents of Report. The report of the administrative head of a facility where the death occurred shall contain all the information set out in Health-General Article, §10-713, Annotated Code of Maryland. The report:</text> <paragraph num="(a)"> <text>May be oral, if followed by a written report within 5 working days from the date of the death, or written; and</text> </paragraph> <paragraph num="(b)"> <text>Shall contain the following relevant information:</text> <paragraph num="(i)"> <text>The name, age, and sex of the deceased;</text> </paragraph> <paragraph num="(ii)"> <text>The time of discovery of the death;</text> </paragraph> <paragraph num="(iii)"> <text>The deceased's place of residence at the time of death;</text> </paragraph> <paragraph num="(iv)"> <text>If the death occurred in a place other than the residence of the deceased, the location of the body at the time of discovery;</text> </paragraph> <paragraph num="(v)"> <text>The place where the body was found;</text> </paragraph> <paragraph num="(vi)"> <text>The name of the person who took custody of the body;</text> </paragraph> <paragraph num="(vii)"> <text>The name of the person evaluating the death, if known;</text> </paragraph> <paragraph num="(viii)"> <text>Whether an autopsy is being performed, if known;</text> </paragraph> <paragraph num="(ix)"> <text>The name, address, and telephone number of the next of kin or legal guardian, if known; and</text> </paragraph> <paragraph num="(x)"> <text>Other information the administrative head of the facility determines should be provided to the medical examiner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The report of the investigation by the Office of the Chief Medical Examiner constitutes an individual file of the Chief Medical Examiner not subject to disclosure under General Provisions Article, §4-101 et seq, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Deputy Medical Examiners/Forensic Investigators."> <paragraph num="A."> <text>The Chief Medical Examiner shall appoint one or more deputy medical examiners and forensic investigators for each county.</text> </paragraph> <paragraph num="B."> <text>The Chief Medical Examiner may appoint a deputy medical examiner from a list of qualified individuals submitted by the county medical society. However, the Chief Medical Examiner may appoint a deputy medical examiner for the county without a list if there is no county medical society or if the medical society does not submit a list of names.</text> </paragraph> <paragraph num="C."> <text>Each deputy medical examiner appointed shall be a physician.</text> </paragraph> <paragraph num="D."> <text>The Chief Medical Examiner shall select a forensic investigator from a list provided by the Deputy Chief Medical Examiner for Statewide services.</text> </paragraph> <paragraph num="E."> <text>Entitled Fees.</text> <paragraph num="(1)"> <text>As provided in the State budget, for each medical examiner’s case investigated, the deputy medical examiner or forensic investigator is entitled to a fee of $150.</text> </paragraph> <paragraph num="(2)"> <text>If the case does not meet the requirements of Health-General Article, §5-308, Annotated Code of Maryland, and is declined, the deputy medical examiner or forensic investigator is entitled to a decline fee of $12.50.</text> </paragraph> <paragraph num="(3)"> <text>The deputy medical examiner is entitled to $25 for certifying the death and completing the death certificate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Body Transportation Reimbursement."> <paragraph num="A."> <text>The deputy medical examiner or forensic investigator shall arrange for body transportation services of human remains from a scene of death in Maryland to a specified location within Maryland.</text> </paragraph> <paragraph num="B."> <text>The deputy medical examiner or forensic investigator shall contact local county funeral directors or appropriate body transportation service providers within their jurisdiction, on a rotational basis, to arrange for body transportation services.</text> </paragraph> <paragraph num="C."> <text>Funeral directors and body transportation service providers are eligible to transport human remains for the Office of the Chief Medical Examiner. However, it is the responsibility of each local funeral director or body transportation service to notify the deputy medical examiner or forensic investigator if they are interested in providing this service for the State.</text> </paragraph> <paragraph num="D."> <text>Providers of body transportation services shall be available 24 hours a day, 7 days per week, 365 days per year to provide body transportation services, as needed, and shall provide their own equipment to transport human remains.</text> </paragraph> <paragraph num="E."> <text>Human remains shall be accorded the proper dignity expected under accepted mortuary standards and practices, and shall be handled in accordance with standard precautions as defined by COMAR 10.06.01.02B and the Office of the Chief Medical Examiner guidelines to protect remains and evidence.</text> </paragraph> <paragraph num="F."> <text>Payment.</text> <paragraph num="(1)"> <text>Providers of body transportation services shall be paid as provided in the State budget, $3.50 per mile, one way, plus any tolls, and a scene response fee of $100, with a minimum total payment of $200 from the scene of death to a designated location. The mileage shall be verified by the OCME.</text> </paragraph> <paragraph num="(2)"> <text>This is the sole compensation the provider is entitled to, and the provider or any other person may not submit a charge to any other party, including the family of the deceased, for this service.</text> </paragraph> <paragraph num="(3)"> <text>In the case of a victim of a homicide, the transport service shall be paid the rate stated in §F(1) of this regulation to transport the body from the site of autopsy or examination to a location within Maryland specified by the victim's family.</text> </paragraph> <paragraph num="(4)"> <text>The Office of the Chief Medical Examiner is responsible for completing the Transportation of Bodies Report for payment.</text> </paragraph> <paragraph num="(5)"> <text>The Office of the Chief Medical Examiner is responsible for providing a replacement body pouch when the body is transported to that office.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Fees for Other Services."> <paragraph num="A."> <text>When a deputy medical examiner, or forensic investigator as the examiner’s designee, is called as a witness before a grand jury or in a criminal case, the examiner or investigator is entitled to:</text> <paragraph num="(1)"> <text>The fee that the court sets; and</text> </paragraph> <paragraph num="(2)"> <text>Any additional compensation that a county or court provides.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When any deputy medical examiner or forensic investigator is called as a witness in a civil case they are entitled to:</text> <paragraph num="(1)"> <text>$20 per hour; and</text> </paragraph> <paragraph num="(2)"> <text>Any additional compensation that a county or court provides.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§5-301 et seq., Estates and Trusts Article, §4-509; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 13, 1939</annotation> <annotation type="History" subtype="Administrative History">Amended December 22, 1950; February 27, 1951; May 15, 1951; June 26, 1951; January 15, 1963; October 22, 1963</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 2, 1993 (20:15 Md. R. 1220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 5, 2008 (35:9 Md. R. 898); November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 5, 2008 (35:9 Md. R. 898); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective May 5, 2008 (35:9 Md. R. 898); November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A, C amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation 13A, B amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14D amended effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A, C amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A, B amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19C, E amended effective November 24, 2014 (41:23 Md. R. 1373)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19E amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective November 6, 2006 (33:22 Md. R. 1733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19E amended effective December 31, 2018 (45:26 Md. R. 1246); May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E amended effective May 11, 2026 (53:9 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20F amended effective May 5, 1997 (24:9 Md. R. 657); November 24, 2014 (41:23 Md. R. 1373)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20F amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective November 6, 2006 (33:22 Md. R. 1733)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20F amended effective May 5, 2008 (35:9 Md. R. 898); August 19, 2024 (51:16 Md. R. 742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 adopted effective November 24, 2014 (41:23 Md. R. 1373)</annotation> </annotations> </chapter> <chapter num="02" heading="Testing Blood and Breath for Alcohol" reason="Repealed"> <annotations> <annotation type="Authority">Courts and Judicial Proceedings Article, §§10-304 and 10-306; Health-General Article, §§5-307 and 5-311; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 4, 2010 (37:20 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 repealed effective May 11, 2026 (53:9 Md. R. 414)</annotation> </annotations> </chapter> </subtitle> <subtitle num="36" heading="Board of Examiners of Psychologists"> <chapter num="01" heading="Procedures"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activities and services” means performing the psychological activities or services that are required training for completing the program in psychology.</text> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual seeking a license or registration to practice psychology in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(4)"> <text>“Central repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(5)"> <text>“Criminal history records check” means the performance of both a State criminal history check by the Central Repository and a national criminal history check by the Federal Bureau of Investigation.</text> </paragraph> <paragraph num="(6)"> <text>“Criminal history records information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, convictions, and the disposition of other pending criminal charges.</text> </paragraph> <paragraph num="(7)"> <text>Fellow.</text> <paragraph num="(a)"> <text>“Fellow” means an individual who has obtained the doctoral degree in psychology, or who has completed all of the academic course requirements for a doctoral degree in psychology, and is gaining additional training and experience in a postdoctoral training program in psychology.</text> </paragraph> <paragraph num="(b)"> <text>“Fellow” includes the term resident.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Intern” means an individual who is:</text> <paragraph num="(a)"> <text>Matriculated in a doctoral degree program in psychology; and</text> </paragraph> <paragraph num="(b)"> <text>Fulfilling program requirements by completing a predoctoral internship training program in psychology.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Practice-oriented program” means a clinical, counseling, or school psychology program, or a combination thereof, or a respecialization program.</text> </paragraph> <paragraph num="(10)"> <text>“Student” means an individual who is:</text> <paragraph num="(a)"> <text>Matriculated in a master's or doctoral degree program in psychology; and</text> </paragraph> <paragraph num="(b)"> <text>Fulfilling program requirements by gaining field or practicum experience.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Supervised course of study” means an organized post-baccalaureate program in psychology with identified faculty and training objectives.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application Required for Licensure or Registration."> <paragraph num="A."> <text>An application packet for licensure is complete when the following conditions are met:</text> <paragraph num="(1)"> <text>The completed application packet is:</text> <paragraph num="(a)"> <text>Submitted to the Board and notarized; and</text> </paragraph> <paragraph num="(b)"> <text>Accompanied by the required nonrefundable application fee in the form of a personal check, cashier’s check or money order;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An application packet includes:</text> <paragraph num="(a)"> <text>Answers to application questions;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of supervised professional experience;</text> </paragraph> <paragraph num="(c)"> <text>Attestations of supervised professional experience submitted to the Board by the persons providing the references;</text> </paragraph> <paragraph num="(d)"> <text>Official transcripts of all post-baccalaureate studies submitted to the Board by the educational institutions;</text> </paragraph> <paragraph num="(e)"> <text>An Examination for Professional Practice in Psychology (EPPP) score, if applicable, submitted to the Board by the Association of State and Provincial Psychology Boards (ASPPB); and</text> </paragraph> <paragraph num="(f)"> <text>Criminal history records check reports are received by the Board; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant who is a nonresident or is not employed within the State submits a statement to show the reasons for seeking licensure in the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An application packet for registration is complete when the following conditions are met:</text> <paragraph num="(1)"> <text>The application packet is:</text> <paragraph num="(a)"> <text>Submitted to the Board and notarized; and</text> </paragraph> <paragraph num="(b)"> <text>Accompanied by the required nonrefundable application fee in the form of a personal check, cashier’s check, or money order;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Official transcripts of all studies are submitted to the Board by the educational insitutions; and</text> </paragraph> <paragraph num="(3)"> <text>Criminal history records check reports are received by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The official date of receipt of the application is the date on which the Board receives both the:</text> <paragraph num="(1)"> <text>Completed application form; and</text> </paragraph> <paragraph num="(2)"> <text>Required, nonrefundable application fee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall notify the applicant of missing required documents not more than 15 business days after receipt of the application.</text> </paragraph> <paragraph num="E."> <text>An application is terminated when:</text> <paragraph num="(1)"> <text>The application has not been completed within 1 year of the date the application is submitted; or</text> </paragraph> <paragraph num="(2)"> <text>The applicant fails either the EPPP, if applicable, or the Maryland examination.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Review of Completed Applications by the Board.</text> <paragraph num="(1)"> <text>The Board shall review an application after the required documents are on file.</text> </paragraph> <paragraph num="(2)"> <text>If the applicant for licensure is applying for limited practice reciprocity, as described in Regulation .07 of this chapter, the application shall be reviewed within 15 business days after the required documents are on file.</text> </paragraph> <paragraph num="(3)"> <text>The Board may request additional information or documentation from the applicant for clarification purposes.</text> </paragraph> <paragraph num="(4)"> <text>An applicant shall be sent notification of the action taken by the Board, to accept or to reject the application.</text> </paragraph> <paragraph num="(5)"> <text>An applicant who is informed of acceptance shall be notified of the time and place of the examinations required in Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant who is informed of acceptance shall submit the required examination fees to the Board.</text> </paragraph> <paragraph num="H."> <text>The Board may not approve an applicant for licensure or registration until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An applicant whose application for licensure or registration is rejected shall be notified of the basis for that rejection.</text> </paragraph> <paragraph num="J."> <text>An applicant may appeal a rejection of application for licensure or registration by notifying the Board in writing, by certified mail, within 60 days of receipt of the Board’s decision, and by:</text> <paragraph num="(1)"> <text>Submitting new or additional evidence to verify or clarify qualifications; or</text> </paragraph> <paragraph num="(2)"> <text>Requesting an informal hearing before the Board.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An applicant who fails an examination may begin the application process again by submitting:</text> <paragraph num="(1)"> <text>A new application for licensure or registration along with the required application fee; and</text> </paragraph> <paragraph num="(2)"> <text>At least one current letter of reference.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Abbreviated Application.</text> <paragraph num="(1)"> <text>A psychologist who holds an active license to practice psychology in good standing in another state and is certified by the American Board of Professional Psychology or credentialed as a Health Service Psychologist by the National Register of Health Service Psychologists may apply for licensure with the Board on an abbreviated application.</text> </paragraph> <paragraph num="(2)"> <text>An abbreviated application for licensure as a psychologist with the Board shall include:</text> <paragraph num="(a)"> <text>Proof of good standing as a licensed psychologist in another state;</text> </paragraph> <paragraph num="(b)"> <text>Proof of certification by the American Board of Professional Psychology or credentialing as a Health Service Psychologist by the National Register of Health Service Psychologists;</text> </paragraph> <paragraph num="(c)"> <text>A passing score on the Maryland Jurisprudence Examination as set forth in Regulation .06A(2) of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>A criminal history records check; and</text> </paragraph> <paragraph num="(e)"> <text>The required, nonrefundable application fee.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may not issue a license on an abbreviated application unless the Board has received the results of the applicant’s criminal history records check.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Education Required for Licensure."> <paragraph num="A."> <text>The applicant for licensure shall have a doctoral degree in psychology as defined in Health Occupations Article, §18-101(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The applicant for registration as a psychology associate shall meet the educational requirement as defined in Health Occupations Article, §18-302(g), Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Professional Supervised Experience Required for Licensure — General."> <paragraph num="A."> <text>An applicant for licensure shall present evidence of having completed 2 years of supervised professional experience before taking the examinations required in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The 2 years of supervised professional experience shall consist of a minimum of 3,250 hours.</text> </paragraph> <paragraph num="C."> <text>Supervision Generally.</text> <paragraph num="(1)"> <text>A minimum of 75 percent of the applicant's supervised professional experience shall be supervised by a psychologist qualified to supervise the activities being performed or the services being rendered.</text> </paragraph> <paragraph num="(2)"> <text>The supervisor shall be:</text> <paragraph num="(a)"> <text>Licensed to practice psychology in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Exempt from licensure under Health Occupations Article, §18-102(3) or 18-301(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Licensed, certified, or exempt from licensure or certification in the state or country in which the supervised professional experience is obtained; or</text> </paragraph> <paragraph num="(d)"> <text>A student, fellow, intern, or resident while pursuing a supervised course of study that the Board approves as qualifying training or experience as provided in Health Occupations Article, §18-301(b)(3), Annotated Code of Maryland, provided that the student, fellow, intern, or resident is supervised by an individual meeting criteria of §C(2)(a), (b) or (c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The supervisor shall ensure that any additional supervision is by an individual who has the requisite skills and training to provide supervision.</text> </paragraph> <paragraph num="(4)"> <text>Psychology associates accruing supervised professional experience toward licensure shall receive the required amount of supervision specified in COMAR 10.36.07.03.</text> </paragraph> <paragraph num="(5)"> <text>The applicant shall ensure that there is adequate documentation of the supervised professional experience.</text> </paragraph> <paragraph num="(6)"> <text>The Board may require additional information to be submitted by the applicant or supervisor to assess the extent and quality of the applicant's supervised professional experience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Supervised Professional Experience — Programs That Are Not Practice-Oriented."> <paragraph num="A."> <text>For applicants for licensure graduating from programs that are not practice-oriented, supervised professional experience may be accrued in professional work in psychology using the methods, principles, and procedures of psychology, including, but not limited to:</text> <paragraph num="(1)"> <text>Teaching;</text> </paragraph> <paragraph num="(2)"> <text>Research; and</text> </paragraph> <paragraph num="(3)"> <text>Industrial or organizational consultation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order for the experience to qualify as full-time supervised professional experience, the applicant shall receive a minimum of 1 hour of individual supervision per week at a face-to-face meeting with the supervisor.</text> </paragraph> <paragraph num="C."> <text>In exceptional circumstances, the Board may waive the requirement for face-to-face supervision:</text> <paragraph num="(1)"> <text>For pre-doctoral experience, if the academic program director attests to the nature of the circumstances and assures the Board that the quality of the supervision was not compromised; or</text> </paragraph> <paragraph num="(2)"> <text>For post-doctoral experience, if the applicant:</text> <paragraph num="(a)"> <text>Petitions the Board for a waiver before beginning the supervised experience; and</text> </paragraph> <paragraph num="(b)"> <text>Offers an alternative modality for supervision, including but not limited to televideo conferencing that does not substantially diminish the adequacy of the supervision.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-2" heading="Supervised Professional Experience — Practice-Oriented Programs."> <paragraph num="A."> <text>For applicants for licensure graduating from practice-oriented programs, supervised professional experience may be accrued through:</text> <paragraph num="(1)"> <text>Pre-internship;</text> </paragraph> <paragraph num="(2)"> <text>Internship;</text> </paragraph> <paragraph num="(3)"> <text>Pre-doctoral post-internship; or</text> </paragraph> <paragraph num="(4)"> <text>Post-doctoral experiences.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The academic training program director or the post-doctoral training supervisor shall attest to the hours accrued to meet the requirements of this regulation on a form required by the Board.</text> </paragraph> <paragraph num="C."> <text>An applicant may utilize pre-internship and pre-doctoral post-internship experience:</text> <paragraph num="(1)"> <text>To accrue up to 1,500 hours toward the supervised professional experience required for licensure; and</text> </paragraph> <paragraph num="(2)"> <text>That occurs following the completion of the first year of the doctoral program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Pre-internship and pre-doctoral post-internship experiences shall:</text> <paragraph num="(1)"> <text>Consist of an organized sequence of training that is of increasing complexity to prepare the student for internship;</text> </paragraph> <paragraph num="(2)"> <text>Follow appropriate academic preparation;</text> </paragraph> <paragraph num="(3)"> <text>Be overseen by the graduate training program;</text> </paragraph> <paragraph num="(4)"> <text>Be an extension of the student's academic coursework and within the scope of education received;</text> </paragraph> <paragraph num="(5)"> <text>Be in service-related activities such as treatment, assessment, interviews, report writing, case presentations, supervision, and consultation for at least 50 percent of the training experience; and</text> </paragraph> <paragraph num="(6)"> <text>Be devoted to face-to-face client contact for at least 25 percent of the training experience.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Pre-internship and pre-doctoral post-internship experiences shall contain a written training plan that:</text> <paragraph num="(1)"> <text>Includes the responsibilities of the student, training site, and graduate training program;</text> </paragraph> <paragraph num="(2)"> <text>Describes how the student's time will be allotted;</text> </paragraph> <paragraph num="(3)"> <text>Ensures the quality, breadth, and depth of the training experience by specifying the:</text> <paragraph num="(a)"> <text>Goals and objectives of the training experience;</text> </paragraph> <paragraph num="(b)"> <text>Methods of evaluation of the student's performance; and</text> </paragraph> <paragraph num="(c)"> <text>Rules governing the training experience;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Specifies the requirements of supervision to include:</text> <paragraph num="(a)"> <text>The nature of supervision;</text> </paragraph> <paragraph num="(b)"> <text>The identities of supervisors; and</text> </paragraph> <paragraph num="(c)"> <text>The form and frequency of feedback from the agency supervisor to the training faculty;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Provides rationale for the training experience based on previous academic preparation and previous training to ensure that the overall experience is organized and sequential; and</text> </paragraph> <paragraph num="(6)"> <text>May be provided to the Board with the application to document the pre-internship or pre-doctoral post-internship experience.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Pre-internship and Pre-doctoral Post-internship Supervision Requirements.</text> <paragraph num="(1)"> <text>Every 20 hours of pre-internship experience and pre-doctoral post-internship shall include the following:</text> <paragraph num="(a)"> <text>At least 2 hours of regularly scheduled, formal, face-to-face individual supervision that addresses the direct psychological services provided by the student; and</text> </paragraph> <paragraph num="(b)"> <text>At least 2 hours of other learning activities such as:</text> <paragraph num="(i)"> <text>Case conferences;</text> </paragraph> <paragraph num="(ii)"> <text>Seminars on applied issues;</text> </paragraph> <paragraph num="(iii)"> <text>Conducting co-therapy with a staff person including discussion of the case; or</text> </paragraph> <paragraph num="(iv)"> <text>Group supervision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In exceptional circumstances, the Board may waive the requirement for face-to-face supervision if the academic program director attests to the nature of the circumstances and assures the Board that the quality of supervision was not compromised.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Internship experiences shall:</text> <paragraph num="(1)"> <text>Consist of a minimum of 1,750 hours of supervised experience; and</text> </paragraph> <paragraph num="(2)"> <text>Be completed within 24 months.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The internship program shall be:</text> <paragraph num="(1)"> <text>Accredited by the American Psychological Association (APA) or the Canadian Psychological Association (CPA);</text> </paragraph> <paragraph num="(2)"> <text>A member program of the Association of Psychology Postdoctoral Internship Centers (APPIC); or</text> </paragraph> <paragraph num="(3)"> <text>Part of an academic program that:</text> <paragraph num="(a)"> <text>Is approved or designated by the:</text> <paragraph num="(i)"> <text>APA;</text> </paragraph> <paragraph num="(ii)"> <text>CPA; or</text> </paragraph> <paragraph num="(iii)"> <text>Association of State and Provincial Psychology Boards (ASPPB)/National Register; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Includes an internship that is approved by the program's academic training director as meeting its criteria for an internship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Post-Doctoral Supervised Professional Experience—Practice-Oriented Programs.</text> <paragraph num="(1)"> <text>A maximum of 1,500 hours of the professional supervised experience may be obtained through post-doctoral supervised experience.</text> </paragraph> <paragraph num="(2)"> <text>Post-doctoral supervised experience shall be completed if an applicant does not have 3,250 hours of pre-doctoral supervised experience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-3" heading="Post-Doctoral Supervised Professional Experience — General."> <paragraph num="A."> <text>A supervisor is ethically and legally responsible for all supervisee work covered by a written supervision agreement.</text> </paragraph> <paragraph num="B."> <text>Supervisees shall use titles indicating their training status, such as “psychology resident”, “psychology intern”, or “psychology supervisee”.</text> </paragraph> <paragraph num="C."> <text>Supervised experience shall be appropriate to the area or areas of professional activity in which the supervisee intends to practice.</text> </paragraph> <paragraph num="D."> <text>There shall be at least 1 hour of individual supervision for every 20 hours of service related activities.</text> </paragraph> <paragraph num="E."> <text>The supervisor and the supervisee shall keep records of experience and supervision hours.</text> </paragraph> <paragraph num="F."> <text>At the conclusion of the post-doctoral supervision experience:</text> <paragraph num="(1)"> <text>The supervisor shall prepare a written evaluation, including:</text> <paragraph num="(a)"> <text>The hours spent in various service related activities;</text> </paragraph> <paragraph num="(b)"> <text>The number of successfully completed supervised hours; and</text> </paragraph> <paragraph num="(c)"> <text>Any hours not successfully completed; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If any hours were not successfully completed, the Board may require additional hours of supervision.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Supervision shall be face-to-face with an on-site supervisor.</text> </paragraph> <paragraph num="H."> <text>Under exceptional circumstances, and before beginning a supervised professional experience, an applicant for licensure may petition the Board to waive the requirement for face-to-face supervision or to receive supervision from a psychologist not on site.</text> </paragraph> <paragraph num="I."> <text>The Board may waive the requirement for face-to-face supervision only when the alternative modality for supervision, including but not limited to televideo conferencing, does not substantially diminish the adequacy of the supervision.</text> </paragraph> <paragraph num="J."> <text>If a supervisee is accruing post-doctoral supervision as a registered psychology associate, the supervisee shall also comply with the requirements of Regulation .04-4 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-4" heading="Post-Doctoral Supervised Professional Experience as a Registered Psychology Associate."> <paragraph num="A."> <text>An applicant accruing post-doctoral supervised experience in an activity that is not exempt under Health Occupations Article, §18-301 or 18-102(3), Annotated Code of Maryland, shall apply to the Board for registration as a psychology associate in accordance with COMAR 10.36.07.</text> </paragraph> <paragraph num="B."> <text>Exempted activities under Health Occupations Article, §§18-301 and 18-102(3), Annotated Code of Maryland, include:</text> <paragraph num="(1)"> <text>Activities as a student, intern, resident, or fellow while pursuing a supervised course of study in psychology that the Board approves as qualifying training and experience;</text> </paragraph> <paragraph num="(2)"> <text>Activities under the supervision of, and in connection with, a psychologist employed by:</text> <paragraph num="(a)"> <text>Any agency of the federal government;</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Department of Juvenile Services;</text> </paragraph> <paragraph num="(c)"> <text>A political subdivision of this State; or</text> </paragraph> <paragraph num="(d)"> <text>A chartered educational institution; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Non-profit activities of a bona fide religious organization that is exempt from taxation under Section 501(c)(3) of the Internal Revenue Code.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Registered psychology associates accruing post-doctoral supervised professional experience toward licensure shall obtain supervision in accordance with the requirements of COMAR 10.36.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Applications for Licensure from Nonresidents."> <paragraph num="A."> <text>When submitting an application for licensure, an applicant who is a nonresident or does not practice psychology in Maryland and who does not intend to reside or practice in Maryland, shall submit a statement showing that the applicant's licensure would be in the interest of the citizens or government of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Board shall determine whether to accept or reject the statement.</text> </paragraph> <paragraph num="C."> <text>In the event of unfavorable determination, the Board shall notify the applicant that the application for licensure has been rejected.</text> </paragraph> <paragraph num="D."> <text>The applicant may appeal this rejection as specified in Regulation .02 of this chapter.</text> </paragraph> <paragraph num="E."> <text>Until licensed to practice psychology in Maryland, an applicant may not practice psychology in Maryland by virtue of holding a valid license or certification to practice psychology in another state unless the Board authorizes a specific exception.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Examinations Required for Licensure or Registration."> <paragraph num="A."> <text>The Board requires applicants for licensure to receive passing scores of at least:</text> <paragraph num="(1)"> <text>A scaled score of 500 on the Examination for Professional Practice in Psychology (EPPP) for examinations administered on or after January 1, 2002, or a score of 73 percent on the Examination for Professional Practice in Psychology (EPPP) prepared and scored before January 1, 2002; and</text> </paragraph> <paragraph num="(2)"> <text>75 percent on the Maryland Examination prepared and scored by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board requires applicants for registration to receive a passing score of at least 75 percent on the Maryland Examination prepared and scored by the Board.</text> </paragraph> <paragraph num="C."> <text>The Board shall ensure that the Maryland Examination tests applicants for licensure or registration on:</text> <paragraph num="(1)"> <text>The Code of Ethics and Professional Conduct; and</text> </paragraph> <paragraph num="(2)"> <text>Other regulations and laws pertaining to the practice of psychology.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall provide each applicant access to all regulations and laws tested on the Maryland Examination.</text> </paragraph> <paragraph num="E."> <text>An applicant is required to take examinations administered by the Board or the Board's agent at the designated times and places.</text> </paragraph> <paragraph num="F."> <text>The Board shall refund the examination fee if a written request to cancel the application or examination is received from the applicant:</text> <paragraph num="(1)"> <text>At least 2 weeks before the examination date; or</text> </paragraph> <paragraph num="(2)"> <text>At a later time if the Board determines there was good cause.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Limited Examination Reciprocity for Licensure Applicants.</text> <paragraph num="(1)"> <text>The Board shall determine the required examinations for each applicant, although the Maryland Examination may not be waived.</text> </paragraph> <paragraph num="(2)"> <text>The Examination for Professional Practice in Psychology may be waived for an applicant authorized by law to practice psychology in another state that did not require the Examination for Professional Practice in Psychology, if the applicant is currently licensed or certified for the independent practice of psychology in another state.</text> </paragraph> <paragraph num="(3)"> <text>The Examination for Professional Practice in Psychology (EPPP) shall be waived for an applicant licensed or certified for the independent practice of psychology in another state who submits evidence of having attained a score of at least 73 percent on any administration of the Examination for Professional Practice in Psychology (EPPP) before January 1, 2002, or a scaled score of 500 on any administration of the Examination for Professional Practice in Psychology (EPPP) on or after January 1, 2002.</text> </paragraph> <paragraph num="(4)"> <text>The examination for Professional Practice in Psychology shall be waived for an applicant who:</text> <paragraph num="(a)"> <text>Is licensed to practice psychology in another state; and</text> </paragraph> <paragraph num="(b)"> <text>Has met the requirements for and holds a current Certificate of Professional Qualification in Psychology issued by the Association of State and Provincial Psychology Boards.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Exceptions to Licensure."> <paragraph num="A."> <text>A student, intern, or fellow may qualify for an exception to licensure while performing the activities and services of a supervised course of study in psychology with the following requirements:</text> <paragraph num="(1)"> <text>The identified faculty shall provide the supervision;</text> </paragraph> <paragraph num="(2)"> <text>The individual shall receive the amount of supervision:</text> <paragraph num="(a)"> <text>Set by the educational or internship program; or</text> </paragraph> <paragraph num="(b)"> <text>In accordance with Regulation .04 of this chapter for:</text> <paragraph num="(i)"> <text>Students or interns who want to obtain the professional supervised experience required for licensure, and</text> </paragraph> <paragraph num="(ii)"> <text>Fellows;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The individual providing psychological services under this exception shall use one of the following titles:</text> <paragraph num="(a)"> <text>Psychology student;</text> </paragraph> <paragraph num="(b)"> <text>Psychology intern;</text> </paragraph> <paragraph num="(c)"> <text>Psychology resident; or</text> </paragraph> <paragraph num="(d)"> <text>Psychology fellow; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>This exception to licensure terminates when the requirements of the training program in psychology are completed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limited Practice Reciprocity.</text> <paragraph num="(1)"> <text>A nonresident certified or licensed to practice psychology may be granted a temporary exception to practice psychology in Maryland if the:</text> <paragraph num="(a)"> <text>Board receives from the applicant a completed application and application fee within 90 days of establishing residence in Maryland and on or before the next application due date;</text> </paragraph> <paragraph num="(b)"> <text>Completed application includes a verification from another state licensing Board or authority that the applicant's license or certification to practice psychology in the other state is in good standing;</text> </paragraph> <paragraph num="(c)"> <text>Applicant is scheduled to take the next Board-administered examinations required for licensure;</text> </paragraph> <paragraph num="(d)"> <text>Board approves the application and sends notification of its action not later than 35 days before the scheduled examination; and</text> </paragraph> <paragraph num="(e)"> <text>Applicant pays the required examination fee to the Board at least 30 days before the scheduled examination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall withdraw the temporary exception to practice psychology if the applicant fails an examination required by the Board.</text> </paragraph> <paragraph num="(3)"> <text>In granting an extension for examination set forth in Health Occupations Article, §18-301(c), Annotated Code of Maryland, the Board shall determine whether the applicant has good cause for being unable to take the first scheduled examination for which the applicant is eligible.</text> </paragraph> <paragraph num="(4)"> <text>In authorizing an exception set forth in Health Occupations Article, §18-301(d), Annotated Code of Maryland, the Board:</text> <paragraph num="(a)"> <text>Shall determine whether the circumstances warrant an exception to licensure, taking into account the:</text> <paragraph num="(i)"> <text>Qualifications of the nonresident psychologist,</text> </paragraph> <paragraph num="(ii)"> <text>Psychological services to be provided, and</text> </paragraph> <paragraph num="(iii)"> <text>Duration of the exception to licensure; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>May impose any limitations on the psychologist's practice of psychology that the Board considers to be appropriate.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="License Renewal, Expiration, and Inactive Status."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>A license shall expire on March 31, unless it is renewed for an additional term as provided in this section.</text> </paragraph> <paragraph num="(2)"> <text>A license may not be renewed for a term longer than 2 years.</text> </paragraph> <paragraph num="(3)"> <text>At least 90 days before the license expires, the Board shall send a renewal notice to the licensee:</text> <paragraph num="(a)"> <text>By first class mail to the last known address of the licensee; or</text> </paragraph> <paragraph num="(b)"> <text>If requested by the licensee, by electronic means to the last known electronic mail address of the licensee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a renewal notice sent by electronic means under §A(3)(b) of this regulation is returned to the Board as undeliverable, the Board shall send a renewal notice to the licensee by first–class mail to the last known address of the licensee.</text> </paragraph> <paragraph num="(5)"> <text>The renewal notice shall state:</text> <paragraph num="(a)"> <text>The procedure to follow;</text> </paragraph> <paragraph num="(b)"> <text>Continuing education requirements;</text> </paragraph> <paragraph num="(c)"> <text>The date on which the current license expires;</text> </paragraph> <paragraph num="(d)"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the license expires; and</text> </paragraph> <paragraph num="(e)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A licensee who did not submit to a criminal history records check upon initial licensure with the Board shall submit to a criminal history records check upon the licensee’s first renewal with the Board after January 1, 2019.</text> </paragraph> <paragraph num="(7)"> <text>Every 6 years following the initial submission of a criminal history records check to the Board, a licensee applying for renewal shall submit to a criminal history records check.</text> </paragraph> <paragraph num="(8)"> <text>Upon receipt of a licensee’s criminal history records information in accordance with §A(6) and (7) of this regulation, the Board shall consider the following factors in determining whether to renew a license:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references, if provided; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the licensee poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>The Board may not renew a license if the Board has not received the results of a criminal history records check required pursuant to §A(6) and (7) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Expiration. A license automatically expires when the psychologist fails to meet the renewal requirements by March 31.</text> </paragraph> <paragraph num="C."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>A psychologist in good standing may request inactive status for 2 years upon:</text> <paragraph num="(a)"> <text>Notification to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of the required fee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee on inactive status may apply to have the inactive license status extended for an additional 2 years upon payment of the inactive status fee.</text> </paragraph> <paragraph num="(3)"> <text>The license on inactive status may be reinstated by:</text> <paragraph num="(a)"> <text>Completing an application for renewal;</text> </paragraph> <paragraph num="(b)"> <text>Paying the renewal fee;</text> </paragraph> <paragraph num="(c)"> <text>Verifying that continuing education requirements have been satisfied as set forth in COMAR 10.36.02; and</text> </paragraph> <paragraph num="(d)"> <text>Submitting to a criminal history records check, if the license has been on inactive status for a period of 1 year or more.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Registration Renewal and Expiration."> <paragraph num="A."> <text>Renewal.</text> <paragraph num="(1)"> <text>A registration shall expire on March 31 unless it is renewed for an additional term as provided in this section.</text> </paragraph> <paragraph num="(2)"> <text>A registration may not be renewed for a term longer than 2 years.</text> </paragraph> <paragraph num="(3)"> <text>At least 90 days before the registration expires, the Board shall send a renewal notice to the registrant:</text> <paragraph num="(a)"> <text>By first class mail to the last known address of the registrant; or</text> </paragraph> <paragraph num="(b)"> <text>By electronic means to the last known electronic mail address of the registrant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The renewal notice shall state:</text> <paragraph num="(a)"> <text>The date the registration expires;</text> </paragraph> <paragraph num="(b)"> <text>Continuing education requirements;</text> </paragraph> <paragraph num="(c)"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </paragraph> <paragraph num="(d)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Every 6 years following the initial submission of a criminal history records check to the Board, a registrant applying for renewal shall submit to a criminal history records check.</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of a registrant’s criminal history records information in accordance with §A(5) of this regulation, the Board shall consider the following factors in determining whether to renew a registration:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references, if provided; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the registrant poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The Board may not renew a registration if the Board has not received the results of a criminal history records check required pursuant to §A(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Expiration. A registration automatically expires when the psychology associate fails to meet the renewal requirements by March 31.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Petitioning for Reinstatement Following Revocation."> <text>The Board may not consider a petition for reinstatement of a license or registration to practice psychology that has been revoked until at least 5 years have passed from the date of revocation.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Board Meetings."> <text>The Board shall meet a minimum of six times a year with additional meetings being scheduled as the business of the Board may require.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Annual Report of the Board."> <paragraph num="A."> <text>The Chairman of the Board shall submit an annual report to the Board for approval before the Board's submission of the report to the Secretary of Health.</text> </paragraph> <paragraph num="B."> <text>The Board shall include in the report:</text> <paragraph num="(1)"> <text>A summary of the more important actions of the Board;</text> </paragraph> <paragraph num="(2)"> <text>Relevant statistical and fiscal data; and</text> </paragraph> <paragraph num="(3)"> <text>A summary of concerns or anticipated future changes in the course of action of the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Petitions."> <paragraph num="A."> <text>Any person may petition the Board in writing for an interpretation of:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 18, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.36.01—10.36.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A copy of the Board's interpretation or decision shall be mailed to the petitioner.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§18-206, 18-301(b)(3) and (d), 18-302—18-305, 18-309, and 18-317, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 25, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G adopted as an emergency provision effective December 23, 1976 (4:2 Md. R. 73); emergency status expired</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.17 repealed and new Regulations .01—.15 adopted effective December 20, 1982 (9:25 Md. R. 2484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective September 25, 1995 (22:19 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective October 23, 1987 (14:23 Md. R. 2412); emergency status extended at 15:7 Md. R. 848</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 16, 1988 (15:10 Md. R. 1202)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 25, 1995 (22:19 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and new Regulation .11 adopted effective October 29, 1990 (17:21 Md. R. 2530)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.15 repealed and new Regulations .01—.12 adopted as an emergency provision effective January 1, 2000 (27:3 Md. R. 325); adopted permanently effective May 1, 2000 (27:8 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 1, 2010 (37:14 Md. R. 938); March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L adopted effective December 24, 2001 (28:25 Md. R. 2192)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective September 1, 2010 (37:14 Md. R. 938)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04-1—.04-4 adopted effective September 1, 2010 (37:14 Md. R. 938)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective December 24, 2001 (28:25 Md. R. 2192)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, C amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective February 12, 2018 (45:3 Md. R. 157)</annotation> </annotations> </chapter> <chapter num="02" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all psychologists and psychology associates who want to renew their licensure or registration in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Activity” means any authoring, editing, learning, presenting, program developing, reviewing, or teaching which meets the objectives of continuing education.</text> </paragraph> <paragraph num="(2)"> <text>“Approved program” means an activity by an authorized sponsor.</text> </paragraph> <paragraph num="(3)"> <text>“Authorized sponsor” means an individual or organization whose programs are accepted by the Board as continuing education activity.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(5)"> <text>“Continuing education (CE)” means learning experiences that:</text> <paragraph num="(a)"> <text>Are professional activities beyond that required for licensure or registration;</text> </paragraph> <paragraph num="(b)"> <text>Are relevant to psychological practice, education, or science;</text> </paragraph> <paragraph num="(c)"> <text>Enable psychologists and psychology associates to keep pace with emerging issues and technology; and</text> </paragraph> <paragraph num="(d)"> <text>Allow psychologists and psychology associates to develop, maintain, and increase competencies in order to improve services to the public and enhance contributions to the profession.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Continuing education (CE) hour” means approximately 1 hour of continuing education activity, unless stated otherwise in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>Course.</text> <paragraph num="(a)"> <text>“Course” means an activity:</text> <paragraph num="(i)"> <text>With one or more instructors who are experts in the topic and impart knowledge or professional skills by a systematic presentation to participants;</text> </paragraph> <paragraph num="(ii)"> <text>That may be offered in person or in real time through electronic means; and</text> </paragraph> <paragraph num="(iii)"> <text>That allows for interaction between the leader and the participants or among the participants.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Course” includes seminars, symposiums, and workshops.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Independent study” means an activity requiring the study of print or electronic materials offered by approved sponsors approved for CE for independent or home study that is not a course as defined in §B(7) of this regulation.</text> </paragraph> <paragraph num="(9)"> <text>“Peer consultation group” means a group of psychologists that meets in person, in a structured and organized manner, and discusses the clinical practice of psychology in order to broaden professional knowledge and expertise.</text> </paragraph> <paragraph num="(10)"> <text>“Reporting period” means a 2-year period beginning on April 1, except as stated in Regulation .04C of this chapter, during which the completion of a minimum number of CE hours is required to renew a license or registration by March 31 following the reporting period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Goals of Continuing Education Activities."> <text>To qualify for approval by the Board, continuing education activities:</text> <paragraph num="A."> <text>Shall meet one or more of the following objectives:</text> <paragraph num="(1)"> <text>Maintains the professional competency of psychologists or psychology associates;</text> </paragraph> <paragraph num="(2)"> <text>Increases the professional skills and knowledge of psychologists or psychology associates;</text> </paragraph> <paragraph num="(3)"> <text>Prepares psychologists or psychology associates for new roles or responsibilities in the practice of psychology; or</text> </paragraph> <paragraph num="(4)"> <text>Expands the science of psychological theory, method, or practice; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>May not include:</text> <paragraph num="(1)"> <text>Business meetings;</text> </paragraph> <paragraph num="(2)"> <text>Professional committee meetings; and</text> </paragraph> <paragraph num="(3)"> <text>Presentations and publications primarily intended for a lay audience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements."> <paragraph num="A."> <text>A psychologist shall complete a minimum of 40 CE hours during each reporting period with a:</text> <paragraph num="(1)"> <text>Maximum of 20 CE hours in independent study;</text> </paragraph> <paragraph num="(2)"> <text>Minimum of 3 CE hours in activities whose content area is:</text> <paragraph num="(a)"> <text>Laws pertaining to the practice of psychology;</text> </paragraph> <paragraph num="(b)"> <text>Ethics and professional conduct in the practice of psychology; or</text> </paragraph> <paragraph num="(c)"> <text>Managing risks associated with the practice of psychology;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Minimum of 3 CE hours in activities designed to enhance competence in the provision of psychological services to culturally diverse populations; and</text> </paragraph> <paragraph num="(4)"> <text>If the psychologist supervised psychology associates during the reporting period, minimum of 3 CE hours in activities designed to enhance competence in the provision of clinical supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A psychology associate shall complete a minimum of 20 CE hours during each reporting period with a:</text> <paragraph num="(1)"> <text>Maximum of 10 CE hours in independent study;</text> </paragraph> <paragraph num="(2)"> <text>Minimum of 3 CE hours in activities whose content area is:</text> <paragraph num="(a)"> <text>Laws pertaining to the practice of psychology;</text> </paragraph> <paragraph num="(b)"> <text>Ethics and professional conduct in the practice of psychology; or</text> </paragraph> <paragraph num="(c)"> <text>Managing risks associated with the practice of psychology; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Minimum of 3 CE hours in activities designed to enhance competence in the provision of psychological services to culturally diverse populations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>During each reporting period, CE hours may be earned only once for the same activity.</text> </paragraph> <paragraph num="D."> <text>Reporting Period.</text> <paragraph num="(1)"> <text>The reporting period for psychologists or psychology associates with license or registration numbers ending with an:</text> <paragraph num="(a)"> <text>Odd digit will be March 31 of odd years; and</text> </paragraph> <paragraph num="(b)"> <text>Even digit or 0 will be March 31 of even years.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For psychologists or psychology associates receiving their initial license or registration with less than 12 months before the end of their reporting period, CE hours are not required for that reporting period.</text> </paragraph> <paragraph num="(3)"> <text>Psychologists receiving their initial license with 12 months or more before the end of their reporting period shall be required to complete 20 CE hours.</text> </paragraph> <paragraph num="(4)"> <text>Psychology associates receiving their initial registration 12 months or more before the end of their reporting period shall be required to complete 10 CE hours.</text> </paragraph> </paragraph> <paragraph num="E."> <text>CE Audits.</text> <paragraph num="(1)"> <text>The Board shall randomly audit the continuing education documentation of all psychologists and psychology associates.</text> </paragraph> <paragraph num="(2)"> <text>Psychologists and psychology associates selected for an audit shall renew their license or registration by March 1.</text> </paragraph> <paragraph num="(3)"> <text>Within 10 days following notification by the Board, a psychologist or psychology associate who is audited shall provide:</text> <paragraph num="(a)"> <text>Proof of completion of continuing education activities;</text> </paragraph> <paragraph num="(b)"> <text>A completed continuing education reporting form; and</text> </paragraph> <paragraph num="(c)"> <text>Any additional information that may be requested by the Board to evaluate completion of CE requirements.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Proof of completion as required in §D(2)(a) of this regulation may include:</text> <paragraph num="(a)"> <text>Certificates of attendance;</text> </paragraph> <paragraph num="(b)"> <text>Transcripts or course syllabi;</text> </paragraph> <paragraph num="(c)"> <text>Reprints of publications;</text> </paragraph> <paragraph num="(d)"> <text>Test results; or</text> </paragraph> <paragraph num="(e)"> <text>Any other proof of completion acceptable to the Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>To earn CE credits for independent study, a psychologist or psychology associate shall:</text> <paragraph num="(a)"> <text>Pass an examination on the activity; and</text> </paragraph> <paragraph num="(b)"> <text>Be awarded a certificate of completion.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Peer Consultation Groups."> <paragraph num="A."> <text>A psychologist may earn CE credit for participation in a peer consultation group.</text> </paragraph> <paragraph num="B."> <text>A peer consultation group shall:</text> <paragraph num="(1)"> <text>Meet to discuss the clinical practice of psychology;</text> </paragraph> <paragraph num="(2)"> <text>Assign a recording secretary to keep attendance and record a brief summary of what was discussed at the meeting;</text> </paragraph> <paragraph num="(3)"> <text>Meet for no less than 1 hour for every session; and</text> </paragraph> <paragraph num="(4)"> <text>Consist of no fewer than three psychologists and no more than six psychologists.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The recording secretary:</text> <paragraph num="(1)"> <text>Shall provide a copy of the meeting summary to each psychologist in attendance and keep a copy in a file maintained by the recording secretary;</text> </paragraph> <paragraph num="(2)"> <text>Shall complete, sign, and provide to each psychologist member a certificate at the end of the reporting period that verifies attendance and specifies the number of hours the psychologist participated in the peer consultation group;</text> </paragraph> <paragraph num="(3)"> <text>Shall ensure that another peer consultation group participant act as a substitute recording secretary at any group meeting at which the recording secretary is absent; and</text> </paragraph> <paragraph num="(4)"> <text>May be a role fulfilled by different psychologist participants during the life of the peer consultation group.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A psychologist participating in a peer consultation group:</text> <paragraph num="(1)"> <text>Shall provide the certificate of attendance to the Board at the time of renewal to verify participation in the peer consultation group;</text> </paragraph> <paragraph num="(2)"> <text>Shall provide copies of the meeting summaries to the Board in the event of a CE audit;</text> </paragraph> <paragraph num="(3)"> <text>Shall only receive CE credit for hours of peer consultation group meetings actually attended; and</text> </paragraph> <paragraph num="(4)"> <text>May participate in more than one peer consultation group, in which case hours of participation in all peer consultation groups shall be added together to calculate CE credit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>CE hours for participating in a peer consultation group may be earned as follows:</text> <paragraph num="(1)"> <text>One CE hour for 7 to 13 hours of participation in a peer consultation group during the reporting period;</text> </paragraph> <paragraph num="(2)"> <text>Two CE hours for 14 to 20 hours of participation in a peer consultation group during the reporting period;</text> </paragraph> <paragraph num="(3)"> <text>Three CE hours for 21 to 27 hours of participation in a peer consultation group during the reporting period; and</text> </paragraph> <paragraph num="(4)"> <text>Four CE hours for 28 or more hours of participation in a peer consultation group during the reporting period.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Extra hours of participation in a peer consultation group may not be carried over to the next reporting period for CE credit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Types of Approved Continuing Education Activities."> <paragraph num="A."> <text>The total number of hours that may be used to fulfill CE requirements for scholarly activities included in §C of this regulation may not exceed 30 hours for psychologists or 15 hours for psychology associates during each 2-year reporting period.</text> </paragraph> <paragraph num="B."> <text>If the activity has more than one author or presenter, CE hours are awarded only to the first three authors.</text> </paragraph> <paragraph num="C."> <text>Approved CE activities include the following:</text> <paragraph num="(1)"> <text>Authoring, editing, presenting, or reviewing a scholarly publication where:</text> <paragraph num="(a)"> <text>A maximum of 20 CE hours for psychologists or 10 CE hours for psychology associates may be earned during each 2-year reporting period for publication by the author or authors of a book during the year of publication;</text> </paragraph> <paragraph num="(b)"> <text>A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period during the year of publication for serving as the:</text> <paragraph num="(i)"> <text>Editor of a book;</text> </paragraph> <paragraph num="(ii)"> <text>Author of a book chapter; or</text> </paragraph> <paragraph num="(iii)"> <text>Author of a scientific peer-reviewed journal article;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period for service by the editor or associate editor of a peer-reviewed scientific journal; and</text> </paragraph> <paragraph num="(d)"> <text>A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period for service as an editorial board member of a peer-reviewed scientific journal;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Three CE hours may be earned for each hour of presentation of the first offering of scholarly papers or courses for an authorized sponsor with a maximum of 15 CE hours for psychologists or 9 CE hours for psychology associates for each 2-year reporting period;</text> </paragraph> <paragraph num="(3)"> <text>Three CE hours may be earned for developing and presenting a scholarly poster with a maximum of 15 CE hours for psychologists or 9 CE hours for psychology associates for each 2-year reporting period; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>A maximum of 4 CE hours may be earned by a psychologist for participation in a peer consultation group during each 2-year reporting period, as specified in Regulation .05-1 of this chapter.</text> </paragraph> <paragraph num="E."> <text>CE hours may be earned for attending courses offered by an authorized sponsor specified in Regulation .06 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Authorized Sponsors."> <text>The following organizations and their approved CE sponsors are authorized sponsors of continuing education acceptable to the Board:</text> <paragraph num="A."> <text>American Psychological Association;</text> </paragraph> <paragraph num="B."> <text>Association for Psychological Science;</text> </paragraph> <paragraph num="C."> <text>American Medical Association;</text> </paragraph> <paragraph num="D."> <text>National Association of Social Workers;</text> </paragraph> <paragraph num="E."> <text>National Association of School Psychologists;</text> </paragraph> <paragraph num="F."> <text>Maryland Department of Health (MDH);</text> </paragraph> <paragraph num="G."> <text>National Institutes of Health; and</text> </paragraph> <paragraph num="H."> <text>Accredited academic institutions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Denial of License or Registration Renewal for Failure to Meet Continuing Education Requirements."> <paragraph num="A."> <text>The Board shall deny a renewal application if:</text> <paragraph num="(1)"> <text>The psychologist or psychology associate did not complete required continuing education hours within the reporting period; or</text> </paragraph> <paragraph num="(2)"> <text>The psychologist or psychology associate did not fulfill audit requirements within 30 days.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon denying a renewal application, the Board shall notify the psychologist or psychology associate by certified mail that the psychologist’s or psychology associate’s renewal application has been denied for failure to comply with the continuing education requirements.</text> </paragraph> <paragraph num="C."> <text>A psychologist or psychology associate may request a hearing on the denial of the renewal application. The request shall be:</text> <paragraph num="(1)"> <text>In writing; and</text> </paragraph> <paragraph num="(2)"> <text>Received by the Board within 30 days of the notification of denial.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If requested by the psychologist or psychology associate, the Board shall convene a hearing within a reasonable time on the denial of the renewal application.</text> </paragraph> <paragraph num="E."> <text>A hearing conducted under this regulation may not be held in accordance with the Maryland Administrative Procedure Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Continuing Education Required for License Reactivation or License or Registration Reinstatement."> <paragraph num="A."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>A psychologist on inactive status who applies for a reactivation of the license with less than 1 year remaining in the reporting period shall:</text> <paragraph num="(a)"> <text>Provide documentation of a minimum of 20 CE hours completed during the current reporting period with not more than 10 hours in independent or home study; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the renewal fee as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A psychologist on inactive status who applies for a reactivation of the license with more than 1 year remaining in the reporting period shall:</text> <paragraph num="(a)"> <text>Provide documentation of a minimum of 20 CE hours completed during the current reporting period, with not more than 10 hours in independent or home study;</text> </paragraph> <paragraph num="(b)"> <text>Complete the remaining 20 CE hours required by the end of the reporting period, with not more than 10 hours in independent or home study; and</text> </paragraph> <paragraph num="(c)"> <text>Pay the renewal fee as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Expired License or Registration.</text> <paragraph num="(1)"> <text>A psychologist who applies for reinstatement of a license that expired less than 1 year from the date of application shall:</text> <paragraph num="(a)"> <text>Provide documentation of a minimum of 20 CE hours completed during the current reporting period, with not more than 10 CE hours in independent study;</text> </paragraph> <paragraph num="(b)"> <text>Complete the remainder of continuing education requirements by the end of the reporting period; and</text> </paragraph> <paragraph num="(c)"> <text>Pay the reinstatement and renewal fees as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A psychology associate who applies for reinstatement of a registration that expired less than 1 year from the date of application shall:</text> <paragraph num="(a)"> <text>Provide documentation of a minimum of 10 CE hours completed during the current reporting period, with not more than 5 CE hours in independent study;</text> </paragraph> <paragraph num="(b)"> <text>Complete the remainder of continuing education requirements by the end of the reporting period; and</text> </paragraph> <paragraph num="(c)"> <text>Pay the reinstatement and renewal fees as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A psychologist who applies for reinstatement of a license that expired more than 1 year but less than 5 years from the date of application shall:</text> <paragraph num="(a)"> <text>Provide documentation of 40 CE hours for the current reporting period; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the reinstatement and renewal fees as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A psychology associate who applies for reinstatement of a registration that expired more than 1 year but less than 5 years from the date of application shall:</text> <paragraph num="(a)"> <text>Provide documentation of 20 CE hours for the current reporting period; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the reinstatement and renewal fees as specified in COMAR 10.36.06.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A psychologist whose license has been expired for more than 5 years and who did not make application to go on inactive status shall reapply for licensure.</text> </paragraph> <paragraph num="(6)"> <text>A psychology associate whose registration has been expired for more than 5 years shall reapply for a registration.</text> </paragraph> <paragraph num="(7)"> <text>The Board may not approve an application for reinstatement until it receives documentation of the minimum CE requirements as set forth in this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Modifications of CE Requirements."> <paragraph num="A."> <text>The Board may approve modifications of the CE requirements.</text> </paragraph> <paragraph num="B."> <text>To request modifications of the CE requirements, a psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Make a written request;</text> </paragraph> <paragraph num="(2)"> <text>Provide evidence of a disability or inability to access activities; and</text> </paragraph> <paragraph num="(3)"> <text>Specify acceptable procedures for completion and documentation of the required hours within the reporting period.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §18-309(f), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 24, 1978 (5:4 Md. R. 227)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A; .03B; .04A and C; .05A, C, and D; and .06 amended effective July 19, 1982 (9:14 Md. R. 1431)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 20, 1989 (16:3 Md. R. 344)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 — .06 repealed and new Regulations .02 — .06 adopted as an emergency provision effective January 1, 2000 (27:3 Md. R. 325); adopted permanently effective May 1, 2000 (27:8 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective October 6, 2008 (35:20 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06 repealed and new Regulations .01 — .09 adopted effective December 31, 2009 (36:26 Md. R. 1995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> </annotations> </chapter> <chapter num="03" heading="Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all contested case hearings held under the authority of Health Occupations Article, §18-315, Annotated Code of Maryland, which concern possible action to be taken by the State Board of Examiners of Psychologists under Health Occupations Article, §18-313, Annotated Code of Maryland, regarding the licensure or registration, or discipline of psychologists and psychology associates. This chapter does not apply to conferences or other informal investigations or proceedings.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of charges and a hearing shall be sent by the Chairman of the Board to the licensee, registrant, or applicant for licensure or registration at least 30 days before the hearing. The notice shall state the date, time, and place of the hearing. It also shall state the issues or charges involved in the proceedings.</text> </paragraph> <paragraph num="B."> <text>If, by reason of the nature of the proceeding, these issues cannot be fully stated in the notice of the hearing in advance or if subsequent amendment of the issues is necessary, the issues and charges shall be clarified and fully stated as soon as practicable.</text> </paragraph> <paragraph num="C."> <text>The written notice of charges and a hearing shall be served on the party in person. Instead of personal service, the Board may serve the notice by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>All parties in interest appearing before the Board at formal contested case hearings have the right to appear in person, alone, or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Procedures."> <paragraph num="A."> <text>Prehearing and Case Resolution Conferences.</text> <paragraph num="(1)"> <text>The Board may set a prehearing conference, or a case resolution conference, or both, upon motion of either party, or on its own motion.</text> </paragraph> <paragraph num="(2)"> <text>The case resolution conference may be used to attempt to settle the case.</text> </paragraph> <paragraph num="(3)"> <text>The prehearing conference may be used to prepare for the hearing by:</text> <paragraph num="(a)"> <text>Delineating the issues,</text> </paragraph> <paragraph num="(b)"> <text>Stipulating to facts, laws, and other matters,</text> </paragraph> <paragraph num="(c)"> <text>Arranging a schedule, and</text> </paragraph> <paragraph num="(d)"> <text>Arranging for the submission of names of witnesses to be called and the subject matter of testimony to be presented in the hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §B(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Parties are not entitled to discovery of items other than as listed in §§B and C of this regulation.</text> </paragraph> <paragraph num="E."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="F."> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if a prehearing conference is not scheduled.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="H."> <text>All motions shall be accompanied by a memorandum of points and authorities and shall be filed with the Board at least 15 working days before the hearing. A copy shall be served on the opposing party. A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party. The Board at its discretion will entertain motions on the day of the hearing.</text> </paragraph> <paragraph num="I."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Board Majority. Each hearing shall be held before a quorum of the Board unless the hearing authority is delegated pursuant to State Government Article, §10-205, Annotated Code of Maryland. A delegation of authority shall be subject to the provisions of State Government Article, §10-216, Annotated Code of Maryland. If hearing authority is not delegated, Board action shall be by a majority vote of those Board members present at the Board hearing.</text> </paragraph> <paragraph num="B."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>Unless the Board's hearing authority is delegated, the Chairman, or a Board member designated by the Chairman, shall be the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Admit evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence;</text> </paragraph> <paragraph num="(e)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall be responsible for order in the hearing and can suspend the proceedings as necessary to maintain order.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the State.</text> </paragraph> <paragraph num="(2)"> <text>The member of the Office of the Attorney General presenting the case on behalf of the State shall have all of the following rights:</text> <paragraph num="(a)"> <text>The submission of evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>Filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board on questions of procedure, evidence, and law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Order of Procedure. The case on behalf of the State shall be presented first. The respondent shall then present his case. After that, rebuttal shall be permitted.</text> </paragraph> <paragraph num="E."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The Board has the power to administer oaths and to compel the attendance of witnesses by subpoena. The Board shall issue subpoenas for any and all witnesses requested in writing by a party.</text> </paragraph> <paragraph num="(2)"> <text>The rules of evidence in all hearings in this chapter shall be as set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Each party has the right to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine every witness called on behalf of the State or other party;</text> </paragraph> <paragraph num="(c)"> <text>Present summation and argument and file objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a party is represented by counsel, the submission of evidence, examination, and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by that counsel.</text> </paragraph> <paragraph num="(5)"> <text>After the direct testimony of the witness is presented and after cross-examination, the Board members may ask questions.</text> </paragraph> <paragraph num="(6)"> <text>If an accused or complainant fails to appear at a hearing after due notice, the Board may reschedule the hearing, or at its discretion, proceed upon the investigation, report, documents, witnesses, and records before it.</text> </paragraph> <paragraph num="(7)"> <text>At the end of the hearing any party may submit briefs of the issues of fact and law involved in the hearing, which briefs shall be filed in the form, with the number of copies, and at the time as the presiding officer may designate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceedings, or part of them, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <paragraph num="A."> <text>Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or his attorney of record. In any order involving patients or clients of a psychologist or psychology associate these individuals will not be referred to by name if in the Board’s opinion confidentiality is in their best interests.</text> </paragraph> <paragraph num="B."> <text>If the psychologist or psychology associate is found not to be in violation of Health Occupations Article, Title 18, Annotated Code of Maryland, the Board immediately shall order a dismissal of the charges and the exoneration of the accused, and no further action may be taken by the Board on the charges involved. Upon a finding not in violation of Health Occupations Article, Title 18, the Board shall expunge the record of the proceedings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>Any party aggrieved by the decision and order may apply for rehearing within 10 days after service on him of the decision and order. The application shall state the grounds for rehearing. The Board shall grant or deny the application within 30 days of its submission to the Chairman of the Board. Action on the application shall lie at the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for rehearing shall stay the enforcement of the order, or excuse the persons affected by it for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>On rehearing, the Board shall only consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal."> <text>Any person whose license or registration has been revoked or suspended by the Board, or any person placed on probation or reprimanded by the Board, may seek judicial review of the Board’s decision. This review shall be in accordance with the provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§18-206 and 18-315; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 adopted as an emergency provision effective September 29, 1980 (7:21 Md. R. 1988); emergency status expired February 14, 1981</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 adopted effective December 3, 1984 (11:24 Md. R. 2069)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective November 26, 1990 (17:23 Md. R. 2732)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 4, 2000 (27:17 Md. R. 1620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> </annotations> </chapter> <chapter num="04" heading="Expungement of Board Records" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: December 10, 1990 (17:24 Md. R. 2837)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective March 13, 1995 (22:5 Md. R. 367)</annotation> </annotations> </chapter> <chapter num="05" heading="Code of Ethics and Professional Conduct"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the professional conduct of licensed psychologists, registered psychology associates, and applicants for both.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(2)"> <text>“Client” means the individual, couple, family, group, business, agency, school, organization, or association that the psychologist or psychology associate provides, or has provided, with professional services.</text> </paragraph> <paragraph num="(3)"> <text>“Multiple relationship” means a relationship in which an individual is concurrently participating in two or more roles with another.</text> </paragraph> <paragraph num="(4)"> <text>“Psychologist” means an individual who is licensed by the Board to practice psychology.</text> </paragraph> <paragraph num="(5)"> <text>“Psychology associate” means an individual who is registered by the Board to practice psychology under the supervision of a psychologist.</text> </paragraph> <paragraph num="(6)"> <text>“Public statement” means any oral, printed, or electronic communication or announcement made by or on behalf of a psychologist, psychology associate, or applicant, and directed to another individual or group.</text> </paragraph> <paragraph num="(7)"> <text>“Sexual intimacies” means acts engaged in with or without clothing involving:</text> <paragraph num="(a)"> <text>Genital contact;</text> </paragraph> <paragraph num="(b)"> <text>Nongenital contact with the hips, loin, thigh, buttocks, or breasts;</text> </paragraph> <paragraph num="(c)"> <text>Exposure or observation of genitals or nude portions of a body involving breasts, buttocks, or genitals; or</text> </paragraph> <paragraph num="(d)"> <text>Other behaviors engaged in for the purpose of sexual arousal or sexual gratification.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibilities and Requirements."> <paragraph num="A."> <text>In General.</text> <paragraph num="(1)"> <text>A psychologist shall be fully responsible for the psychologist’s professional decisions and professional actions;</text> </paragraph> <paragraph num="(2)"> <text>A psychologist and psychology associate shall be jointly responsible for the psychology associate’s professional decisions and professional actions.</text> </paragraph> <paragraph num="(3)"> <text>A psychologist or psychology associate shall:</text> <paragraph num="(a)"> <text>Notify the Board in writing within 60 days if a license, certificate, permit, or registration granted by another authority for the practice of psychology has been limited, restricted, suspended, revoked, or subjected to other disciplinary action by the particular licensing or granting authority;</text> </paragraph> <paragraph num="(b)"> <text>Provide psychological services only in the context of clear professional and scientific relationships and roles accepted by the standard of practice of the discipline of psychology;</text> </paragraph> <paragraph num="(c)"> <text>Make known the psychologist’s or psychology associate’s commitment to the Code of Ethics and Professional Conduct and resolve potential conflicts with the Code of Ethics and Professional Conduct in a responsible manner;</text> </paragraph> <paragraph num="(d)"> <text>Treat all individuals in a fair and objective manner without discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, or another basis proscribed by law;</text> </paragraph> <paragraph num="(e)"> <text>Interact with individuals in the workplace in a respectful manner without engaging in behavior that is harassing or demeaning; and</text> </paragraph> <paragraph num="(f)"> <text>Comply with a Board order.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A psychologist or psychology associate may not:</text> <paragraph num="(a)"> <text>Knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record or billing record or other information about a patient in an effort to conceal the information from use as evidence in an administrative, civil, or criminal proceeding;</text> </paragraph> <paragraph num="(b)"> <text>Intimidate or influence an individual to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings;</text> </paragraph> <paragraph num="(c)"> <text>Hinder, prevent, or otherwise delay an individual from making information available to the Board in furtherance of an investigation of the Board; or</text> </paragraph> <paragraph num="(d)"> <text>Take credit for work the psychologist or psychology associate has not actually performed or supervised.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision. A psychologist shall:</text> <paragraph num="(1)"> <text>Be responsible for the actions of those the psychologist supervises; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that those the psychologist employs act in accordance with the Maryland Psychologists Act and the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Research. A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Respect the dignity and protect the welfare of research subjects, and comply with all relevant statutes, regulations, and institutional and administrative rules concerning treatment of research subjects;</text> </paragraph> <paragraph num="(2)"> <text>Take responsibility for the ethical treatment of research participants by collaborators, supervisees, and employees;</text> </paragraph> <paragraph num="(3)"> <text>Acquire, care for, use and dispose of animals in compliance with laws, regulations, and applicable professional standards;</text> </paragraph> <paragraph num="(4)"> <text>Ensure appropriate consideration of the comfort, health and humane treatment of animals used in research;</text> </paragraph> <paragraph num="(5)"> <text>Make clear, either as a researcher or a writer, the nature of the participation, as well as the costs and the psychologist's obligations to be accepted by research participants;</text> </paragraph> <paragraph num="(6)"> <text>Obtain required approval from host institutions before conducting research; and</text> </paragraph> <paragraph num="(7)"> <text>Report research findings accurately, presenting only the psychologist’s or psychology associate’s work or making appropriate citations when needed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Teaching. A psychologist or psychology associate shall ensure that statements in course catalogs, seminar brochures, and course outlines are accurate and not misleading, particularly in terms of the:</text> <paragraph num="(1)"> <text>Subject matter to be covered;</text> </paragraph> <paragraph num="(2)"> <text>Nature of course experiences; and</text> </paragraph> <paragraph num="(3)"> <text>Basis for evaluating performance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Competence."> <paragraph num="A."> <text>Professional Competence. A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Limit practice to the areas of competence by which proficiency has been gained through education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Acquire the special education and training needed to address the cultural differences of special populations;</text> </paragraph> <paragraph num="(3)"> <text>Avoid unfair discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, or other basis proscribed by law;</text> </paragraph> <paragraph num="(4)"> <text>Use interventions and assessment techniques only when the psychologist or psychology associate knows that the circumstances are appropriate applications of those interventions and techniques, supported by reliability, validation, standardization, and outcome studies;</text> </paragraph> <paragraph num="(5)"> <text>Maintain competence by meeting the requirements of continuing education as set forth in COMAR 10.36.02;</text> </paragraph> <paragraph num="(6)"> <text>Engage in ongoing consultation with other psychologists, psychology associates, or relevant professionals and seek appropriate education, training, and experience, when developing competence in a new service or technique; and</text> </paragraph> <paragraph num="(7)"> <text>Document and maintain appropriate records of professional and scientific work.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Impaired Competence.</text> <paragraph num="(1)"> <text>A psychologist or psychology associate shall:</text> <paragraph num="(a)"> <text>Represent accurately and objectively the psychologist’s or psychology associate’s professional qualifications; and</text> </paragraph> <paragraph num="(b)"> <text>Seek competent professional assistance to determine whether to suspend, terminate, or limit the scope of professional or scientific activities when the psychologist or psychology associate becomes or is made aware that the psychologist’s or psychology associate’s competence is impaired.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A psychologist or psychology associate may not:</text> <paragraph num="(a)"> <text>Undertake or continue a professional relationship with a client when the competence or objectivity of the psychologist or psychology associate is or could reasonably be expected to be impaired due to:</text> <paragraph num="(i)"> <text>Mental, emotional, physiological, pharmacological, substance abuse, or personal problems; or</text> </paragraph> <paragraph num="(ii)"> <text>The psychologist’s or psychology associate’s present or previous familial, social, sexual, emotional, financial, supervisory, political, administrative, or legal relationship with the client or a person associated with or related to the client; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Engage in other relationships that could limit the psychologist’s or psychology associate’s objectivity or create a conflict of interest or the appearance of a conflict of interest.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Representation of Services and Fees."> <paragraph num="A."> <text>Public Statements and Advertising.</text> <paragraph num="(1)"> <text>A psychologist or psychology associate shall:</text> <paragraph num="(a)"> <text>Represent accurately and objectively the psychologist’s or psychology associate’s professional qualifications, education, experience, and areas of competence;</text> </paragraph> <paragraph num="(b)"> <text>Correct others who misrepresent the psychologist’s or psychology associate’s professional qualifications or affiliations; and</text> </paragraph> <paragraph num="(c)"> <text>Identify a paid advertisement as a paid advertisement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A psychologist or psychology associate may not:</text> <paragraph num="(a)"> <text>Misrepresent, directly or by implication, the affiliations or the purposes or characteristics of institutions and organizations with which the psychologist or psychology associate is affiliated;</text> </paragraph> <paragraph num="(b)"> <text>Claim organizational membership in a manner that suggests specialized competence or qualifications that the psychologist or psychology associate does not have;</text> </paragraph> <paragraph num="(c)"> <text>Make public statements that contain:</text> <paragraph num="(i)"> <text>False, fraudulent, misleading, or deceptive statements;</text> </paragraph> <paragraph num="(ii)"> <text>Partial disclosures of relevant facts that misrepresent, mislead, or deceive; or</text> </paragraph> <paragraph num="(iii)"> <text>Statements that create false or unjustified expectations of favorable results; or</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Solicit, either in person or through others, business or testimonial endorsements from clients who are vulnerable to undue influence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Informed Consent. When conducting research or providing assessment, psychotherapy, counseling, or consulting with an individual or organization in person or by electronic transmission or other forms of communication, a psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>In general:</text> <paragraph num="(a)"> <text>Obtain informed consent using appropriate language understandable to the client;</text> </paragraph> <paragraph num="(b)"> <text>Vary appropriate informed consent forms and procedures to ensure that the client:</text> <paragraph num="(i)"> <text>Has the capacity to consent;</text> </paragraph> <paragraph num="(ii)"> <text>Has been provided with information concerning participation in the activity that reasonably might affect the willingness to participate, including limits of confidentiality and monetary costs or reimbursements;</text> </paragraph> <paragraph num="(iii)"> <text>Is aware of the voluntary nature of participation and has freely and without undue influence expressed consent; and</text> </paragraph> <paragraph num="(iv)"> <text>Is given the opportunity to ask questions and receive answers regarding the activity;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>In research, make clear to the client:</text> <paragraph num="(a)"> <text>The nature of the participation as well as the costs and other obligations to be accepted by research participants;</text> </paragraph> <paragraph num="(b)"> <text>The purpose and nature of any evaluations, treatment, or educational or training procedure;</text> </paragraph> <paragraph num="(c)"> <text>All aspects of research including any risks and consequences of the research that will reasonably be expected to influence willingness to participate;</text> </paragraph> <paragraph num="(d)"> <text>The right to withdraw from treatment or research at any time; and</text> </paragraph> <paragraph num="(e)"> <text>The notification that permission shall be given by the client, student, or research participant before the use of observation or electronic taping, recording, or filming procedures; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In therapeutic relationships, explain to the client:</text> <paragraph num="(a)"> <text>The clarification of reasonable expectations;</text> </paragraph> <paragraph num="(b)"> <text>The nature and purpose of testing, reports, and consultations;</text> </paragraph> <paragraph num="(c)"> <text>The limits of confidentiality;</text> </paragraph> <paragraph num="(d)"> <text>Specific information concerning fees, billing, and electronic services available in the payment of fees;</text> </paragraph> <paragraph num="(e)"> <text>Psychotherapeutic schedules; and</text> </paragraph> <paragraph num="(f)"> <text>The process and conditions of termination of therapy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Financial Arrangements and Fees. A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Make advance financial arrangements that are clearly understood by the client;</text> </paragraph> <paragraph num="(2)"> <text>Inform the client about the possibility of initiating a collection procedure before using that procedure;</text> </paragraph> <paragraph num="(3)"> <text>Comply with the provisions regarding patient referrals contained in Health Occupations Article, §§1-301 — 1-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Make full disclosure in advance to the client of any remuneration given or received for making or accepting referrals; and</text> </paragraph> <paragraph num="(5)"> <text>Refrain from signing statements for insurance purposes as though the psychologist or psychology associate provided a service that was actually provided by someone else.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Psychological Assessment."> <paragraph num="A."> <text>A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Perform evaluations and diagnostic services in a professional relationship when assessment data is indicated by the professional context;</text> </paragraph> <paragraph num="(2)"> <text>Administer psychological tests in keeping with accepted standards of practice and avoid use of obsolete measurement techniques;</text> </paragraph> <paragraph num="(3)"> <text>Use appropriate or specialized assessment instruments when working with individuals from special populations;</text> </paragraph> <paragraph num="(4)"> <text>Use appropriate scoring devices, norms, and standards in evaluating test protocols;</text> </paragraph> <paragraph num="(5)"> <text>Select scoring and interpretive programs and services on the basis of evidence of the validity of the programs and procedures;</text> </paragraph> <paragraph num="(6)"> <text>Report the results of assessment procedures by:</text> <paragraph num="(a)"> <text>Using adequate interpretative aids or explanations;</text> </paragraph> <paragraph num="(b)"> <text>Including any deficiencies of the assessment norms for the individual assessed, and any relevant reservations or qualifications which affect the validity, reliability, or other interpretation of results; and</text> </paragraph> <paragraph num="(c)"> <text>Avoiding misuse of automated interpretative reports;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Base recommendations or decisions on test results that are reasonably current and not obsolete;</text> </paragraph> <paragraph num="(8)"> <text>Supply a manual or other printed material which fully describes the development of the assessment procedure or service, the rationale, evidence of validity and reliability, and characteristics of the normative population when offering an assessment procedure or automated interpretation service to other professionals; and</text> </paragraph> <paragraph num="(9)"> <text>Release test results only to patients and clients as appropriate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A psychologist or psychology associate may not:</text> <paragraph num="(1)"> <text>Release test protocols or raw data to persons who are not qualified to interpret and use the information appropriately, except as required by law;</text> </paragraph> <paragraph num="(2)"> <text>Encourage or promote the use of psychological assessment techniques or computerized assessment and interpretation by unqualified persons; or</text> </paragraph> <paragraph num="(3)"> <text>Reproduce test materials or describe psychological tests or other assessment devices in popular publications, lectures, or public presentation in ways that might compromise their validity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Client Welfare."> <paragraph num="A."> <text>A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Take appropriate steps to disclose to all involved parties conflicts of interest that arise, with respect to a psychologist’s or psychology associate’s clients, in a manner that is consistent with applicable confidentiality requirements; and</text> </paragraph> <paragraph num="(2)"> <text>Make arrangements for another appropriate professional to deal with emergency needs of the psychologist’s or psychology associate’s clients as appropriate, during periods of anticipated absences from professional availability.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Exploitation. A psychologist or psychology associate may not:</text> <paragraph num="(1)"> <text>Exploit or harm clients, colleagues, students, research participants, or others;</text> </paragraph> <paragraph num="(2)"> <text>Take actions that violate or diminish the legal and civil rights of clients or of others who may be affected by the action;</text> </paragraph> <paragraph num="(3)"> <text>Exploit the trust and dependency of clients, students, and subordinates;</text> </paragraph> <paragraph num="(4)"> <text>Allow personal, social, religious, organizational, financial, or political situations and pressures to lead to a misuse of their influence; or</text> </paragraph> <paragraph num="(5)"> <text>Enter into a new nonpsychological, nonprofessional relationship with a former client that is considered exploitative dependent on, but not limited to:</text> <paragraph num="(a)"> <text>The nature, duration, and intensity of professional services rendered to the client;</text> </paragraph> <paragraph num="(b)"> <text>The length of the professional relationship;</text> </paragraph> <paragraph num="(c)"> <text>The length of time between the termination of the professional relationship and the initiation of the nonprofessional relationship;</text> </paragraph> <paragraph num="(d)"> <text>The mental stability of the psychologist or psychology associate and former client;</text> </paragraph> <paragraph num="(e)"> <text>The circumstances of termination, including, but not limited to, statements or actions of the psychologist or psychology associate suggesting or inviting the possibility of a post-termination relationship; and</text> </paragraph> <paragraph num="(f)"> <text>The likelihood of adverse impact on the client.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Sexual Misconduct. A psychologist or psychology associate may not:</text> <paragraph num="(1)"> <text>Engage in sexual intimacies with a current client;</text> </paragraph> <paragraph num="(2)"> <text>Engage in sexual intimacies with a former client:</text> <paragraph num="(a)"> <text>For at least 2 years after the cessation or termination of professional services; or</text> </paragraph> <paragraph num="(b)"> <text>After the 2 years following the cessation or termination of professional services if the sexual relationship is exploitative in light of the following factors:</text> <paragraph num="(i)"> <text>The nature, duration, and intensity of professional services rendered to the client;</text> </paragraph> <paragraph num="(ii)"> <text>The length of the professional relationship;</text> </paragraph> <paragraph num="(iii)"> <text>The length of time between the termination of the professional relationship and the initiation of the nonprofessional relationship;</text> </paragraph> <paragraph num="(iv)"> <text>The mental stability of the psychologist or psychology associate and former client;</text> </paragraph> <paragraph num="(v)"> <text>The circumstances of termination including, but not limited to, statements, or actions of the psychologist or psychology associate suggesting or inviting the possibility of a post-termination sexual or romantic relationship; and</text> </paragraph> <paragraph num="(vi)"> <text>The likelihood of adverse impact on the former client;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Engage in sexual intimacies with individuals known to be the parents, guardians, spouses, domestic partners, sexual partners, children, or siblings of the client or for at least 2 years after cessation or termination of professional services;</text> </paragraph> <paragraph num="(4)"> <text>Terminate a professional relationship with a client for the purpose of engaging in sexual intimacies with one of the individuals set forth in §C(3) of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Engage in sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered; or</text> </paragraph> <paragraph num="(6)"> <text>Engage in sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Harassment. A psychologist or psychology associate may not:</text> <paragraph num="(1)"> <text>Engage in sexual solicitation, physical advances, or verbal or nonverbal conduct that is sexual in nature, which behavior occurs in connection with the psychologist’s or psychology associate’s professional role;</text> </paragraph> <paragraph num="(2)"> <text>Engage in sexual harassment of the psychologist’s or psychology associate’s past or present clients, supervisees, research participants, or employees, with deliberate or repeated comments, gestures, or physical contacts of a sexual nature; or</text> </paragraph> <paragraph num="(3)"> <text>Create a hostile workplace or educational environment by unwelcome and offensive behaviors that are sufficiently severe or intense to be abusive of a reasonable individual in that environment whether it consists of a single act or of multiple persistent or pervasive acts.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Provide psychological services for minor children or for adults who have legal guardians only with appropriate authorization; and</text> </paragraph> <paragraph num="(2)"> <text>Take special care to protect the interests of minors or clients who are unable to give voluntary, informed consent.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Termination of Services. A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Make or recommend referral to other professional, technical, or administrative resources if the referral is clearly in the best interest of the client; and</text> </paragraph> <paragraph num="(2)"> <text>Unless precluded by the actions of the client, terminate the professional relationship in an appropriate manner, notify the client in writing of this termination, and assist the client in obtaining services from another professional, if:</text> <paragraph num="(a)"> <text>It is reasonably clear the client is not benefiting from the relationship;</text> </paragraph> <paragraph num="(b)"> <text>A multiple relationship develops or is discovered after the professional relationship has been initiated;</text> </paragraph> <paragraph num="(c)"> <text>Impaired competency or objectivity develops or is discovered after a professional relationship has been initiated; or</text> </paragraph> <paragraph num="(d)"> <text>The psychologist or psychology associate has been threatened or otherwise endangered by the client or another person with whom the client has a relationship.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Confidentiality and Client Records."> <paragraph num="A."> <text>A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Maintain confidentiality regarding information obtained from a client in the course of the psychologist’s or psychology associate’s work;</text> </paragraph> <paragraph num="(2)"> <text>Discuss the requirements and limitations of confidentiality at the beginning of the professional relationship or at the intake interview;</text> </paragraph> <paragraph num="(3)"> <text>Safeguard information obtained in clinical or consulting relationships or evaluative data concerning children, students, employees, and others obtained in the course of practice, teaching, research, or other professional services;</text> </paragraph> <paragraph num="(4)"> <text>Release mental health records or other confidential information only as permitted or required by law;</text> </paragraph> <paragraph num="(5)"> <text>Obtain written permission for the electronic recording of interviews;</text> </paragraph> <paragraph num="(6)"> <text>Avoid undue invasion of privacy by ensuring that written and oral reports contain only data relevant to the purpose of the evaluation;</text> </paragraph> <paragraph num="(7)"> <text>Treat any assessment result or interpretation regarding an individual as confidential information; and</text> </paragraph> <paragraph num="(8)"> <text>Obtain informed written consent before presenting in writing, lecture, or other public forums identifying information obtained during the course of professional work, and disguise this information when case reports or other confidential information are used as a basis for teaching or research.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Legal and Ethical Limits. A psychologist or psychology associate shall inform:</text> <paragraph num="(1)"> <text>Clients of the legal and ethical limits of confidentiality;</text> </paragraph> <paragraph num="(2)"> <text>Clients below the age of minority, or who have legal guardians, of the limits the law imposes on the right of confidentiality with respect to communications with the psychologist or psychology associate, to the extent that the client can understand, at the beginning of the professional relationship;</text> </paragraph> <paragraph num="(3)"> <text>Research participants of any limits to confidentiality as part of the informed consent; and</text> </paragraph> <paragraph num="(4)"> <text>Clients of the duty imposed by law to inform authorities of abuse and neglect of children and vulnerable adults.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Record Keeping. A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Keep records of a patient's condition and assessment results;</text> </paragraph> <paragraph num="(2)"> <text>Maintain clinical records of informed consent, presenting problems, diagnosis, fee arrangements, dates and substance of each billed service, original test data with results and other evaluative material, and the results of any formal consultations with other professionals;</text> </paragraph> <paragraph num="(3)"> <text>Make provisions for maintaining confidentiality in the storage and disposal of written and electronic records;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that professional records are maintained for a period consistent with State and federal laws;</text> </paragraph> <paragraph num="(5)"> <text>Limit access to client records and ensure that a person working under the psychologist’s or psychology associate’s authority including, but not limited to office personnel, comply with the requirements for confidentiality of client material; and</text> </paragraph> <paragraph num="(6)"> <text>Provide evaluations or treatment reports within a reasonable time consistent with State and federal laws on proper and lawful requests by a client, insurance carrier, court, institution, or other authorized health provider.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 18-311, and 18-313(7), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 26, 1992 (19:21 Md. R. 1891)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 repealed and new Regulations .01 — .08 adopted effective November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 7, 2004 (31:11 Md. R. 857); May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> </annotations> </chapter> <chapter num="06" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all those licensed or applying for licensure by the Board, or registering as a psychology associate.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Licensure application fee — $300;</text> </paragraph> <paragraph num="B."> <text>Psychology associate registration application fee — $200;</text> </paragraph> <paragraph num="C."> <text>Examination fees:</text> <paragraph num="(1)"> <text>National examination — $650;</text> </paragraph> <paragraph num="(2)"> <text>State examination — $250;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Verification of licensure or registration — $20;</text> </paragraph> <paragraph num="E."> <text>Biennial licensure renewal fee — $400;</text> </paragraph> <paragraph num="F."> <text>Biennial registration renewal fee — $300;</text> </paragraph> <paragraph num="G."> <text>Late fee — $50;</text> </paragraph> <paragraph num="H."> <text>Inactive status fee (every 2 years) — $200;</text> </paragraph> <paragraph num="I."> <text>Reinstatement fee for license — $700;</text> </paragraph> <paragraph num="J."> <text>Reinstatement fee for registration — $600;</text> </paragraph> <paragraph num="K."> <text>Penalty for returned check — $50;</text> </paragraph> <paragraph num="L."> <text>Duplicate license or registration:</text> <paragraph num="(1)"> <text>Wall certificate — $50;</text> </paragraph> <paragraph num="(2)"> <text>Wallet card — $30;</text> </paragraph> </paragraph> <paragraph num="M."> <text>Temporary Exception to Practice — $100.</text> </paragraph> <paragraph num="N."> <text>Roster of licensed psychologists or registered psychology associates — $150.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Refunds."> <text>Application fees are nonrefundable. Examination fees shall be refunded if the request to cancel an examination is received in writing 2 weeks before the examination date.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Examiners of Psychologists. Licensees and applicants shall be notified of the change.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="One-Time Transitional Annual Licensure Renewal Fee."> <text>For licensure renewal due between January 1 and March 31, 2000, a licensee whose license number is an odd number shall submit one-half of the biennial renewal fee for a 1-year license.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Assessment for Health Care Professionals."> <text>The Maryland Health Care Commission (MHCC) assesses a fee for health care professionals which the applicant shall pay at the time of license renewal as specified in COMAR 10.25.02.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§18-206, 18-207, 18-301, and 18-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 26, 1992 (19:21 Md. R. 1892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective December 17, 2001 (29:1 Md. R. 18); amended permanently effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 21, 2011 (38:6 Md. R. 395); May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective September 27, 1993 (20:19 Md. R. 1472); September 20, 1999 (26:19 Md. R. 1448); August 6, 2001 (28:15 Md. R. 1397)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective September 27, 1993 (20:19 Md. R. 1472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L adopted effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective September 20, 1999 (26:19 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective September 20, 1999 (26:19 Md. R. 1448)</annotation> </annotations> </chapter> <chapter num="07" heading="Psychology Associate"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to:</text> <paragraph num="A."> <text>Registered psychology associates; and</text> </paragraph> <paragraph num="B."> <text>Licensed psychologists who supervise psychology associates.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(2)"> <text>“Full-time” means the provision of psychological services through direct client contact at least 26 hours per week.</text> </paragraph> <paragraph num="(3)"> <text>“Registered psychology associate” means an individual who meets the requirements set forth in the Maryland Psychologists Act and is registered by the Board to practice psychology under the supervision of a licensed psychologist.</text> </paragraph> <paragraph num="(4)"> <text>“Supervisor” means a psychologist licensed in Maryland with at least 2 years of post-licensure experience who supervises a registered psychology associate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibilities of Supervisors."> <paragraph num="A."> <text>Requirements of the Supervisory Relationship.</text> <paragraph num="(1)"> <text>A supervisor of a registered psychology associate shall supervise only in those areas within the supervisor’s competence as determined by education, training, and experience.</text> </paragraph> <paragraph num="(2)"> <text>A supervisor shall ensure that a registered psychology associate is practicing within the scope of the registered psychology associate’s competence as demonstrated by the registered psychology associate’s documented education, training, and experience in the particular practice area.</text> </paragraph> <paragraph num="(3)"> <text>A supervisor:</text> <paragraph num="(a)"> <text>May delegate some supervisory responsibilities to another psychologist licensed by the Board to:</text> <paragraph num="(i)"> <text>Ensure competent supervision of a registered psychology associate in areas outside the area of expertise of the supervisor; or</text> </paragraph> <paragraph num="(ii)"> <text>Provide temporary supervision when the supervisor is unavailable; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Shall:</text> <paragraph num="(i)"> <text>Document the delegated supervision in accordance with Regulation .05B(1) of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Continue to assume responsibility for the psychological services and activities performed by the registered psychology associate during the period in which supervisory responsibilities have been delegated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Adequate and appropriate supervision shall be determined by the:</text> <paragraph num="(a)"> <text>Education, training, and experience of the registered psychology associate;</text> </paragraph> <paragraph num="(b)"> <text>Nature and extent of services performed by the registered psychology associate; and</text> </paragraph> <paragraph num="(c)"> <text>Setting in which the services are performed.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Adequate and appropriate supervision for full-time provision of psychological services by each registered psychology associate shall consist of:</text> <paragraph num="(a)"> <text>One hour or more per week for a registered psychology associate who has earned a doctoral degree in psychology;</text> </paragraph> <paragraph num="(b)"> <text>Two hours or more per week for a registered psychology associate who has been admitted to a candidacy for a doctoral degree in clinical psychology, counseling psychology, school psychology, or education with a field of specialization in psychology or counseling psychology in a program accredited by the Council for Higher Education, who has satisfactorily:</text> <paragraph num="(i)"> <text>Completed at least 3 years of postgraduate education in psychology; and</text> </paragraph> <paragraph num="(ii)"> <text>Passed preliminary doctoral examinations; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Three hours or more per week for all other registered psychology associates.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>In addition to the requirements set forth in §A(5) of this regulation, adequate supervision of a registered psychology associate shall include a minimum of 1 hour of supervision for every 5 hours of comprehensive evaluation and testing of a client.</text> </paragraph> <paragraph num="(7)"> <text>The amount of supervision required by §A(5) and (6) of this regulation:</text> <paragraph num="(a)"> <text>May be reduced by one-half for a registered psychology associate who has had 3 years of full-time experience, or its equivalent, as a psychology associate; and</text> </paragraph> <paragraph num="(b)"> <text>May be reduced proportionately for a registered psychology associate who provides services less than full-time.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Adequate and appropriate supervision shall be:</text> <paragraph num="(a)"> <text>Provided to a registered psychology associate at a face-to-face meeting, which may include videoconferencing, unless granted an exemption by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Exclusive of supervision on administrative issues.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>If the supervisor is not practicing at the same site as the registered psychology associate, the supervisor shall conduct quarterly site visits at the location where the registered psychology associate is providing services,.</text> </paragraph> <paragraph num="(10)"> <text>The registered psychology associate shall inform the supervisor of all complaints, regardless of nature or origin, related to conduct of or services provided by the registered psychology associate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Termination of the Supervisory Relationship.</text> <paragraph num="(1)"> <text>Either party to the supervisory relationship may terminate the supervisory relationship.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a termination of a supervisory relationship, the registered psychology associate may only continue to practice psychology under the supervision of another licensed psychologist who meets the requirements of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The registered psychology associate and the supervisor in the terminated supervisory relationship shall submit notice of the termination to the Board in accordance with Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Responsibilities of the Supervisor.</text> <paragraph num="(1)"> <text>A supervisor shall be available for emergency consultation and direction of a registered psychology associate, and for client management.</text> </paragraph> <paragraph num="(2)"> <text>A supervisor may supervise a maximum of five registered psychology associates.</text> </paragraph> <paragraph num="(3)"> <text>A supervisor may not engage in supervision that would constitute a multiple relationship.</text> </paragraph> <paragraph num="(4)"> <text>A supervisor shall take responsibility for all services provided by a registered psychology associate under the supervisor’s supervision.</text> </paragraph> <paragraph num="(5)"> <text>A supervisor shall comply with additional continuing education requirements for supervisors set forth in COMAR 10.36.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representations to the Public."> <paragraph num="A."> <text>A registered psychology associate:</text> <paragraph num="(1)"> <text>Shall make personal reference as a “registered psychology associate under the supervision of a licensed psychologist” in all promotional materials and other communications relating to the provision of psychological services; and</text> </paragraph> <paragraph num="(2)"> <text>May not make personal reference as a psychologist, either orally or in writing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisor or registered psychology associate shall inform all clients of the supervision arrangement and its possible implications for insurance reimbursement and confidentiality.</text> </paragraph> <paragraph num="C."> <text>A supervisor and registered psychology associate shall ensure that those who are billed for services by the registered psychology associate are informed that the registered psychology associate provided the services under the supervision of a licensed psychologist.</text> </paragraph> <paragraph num="D."> <text>A registered psychology associate may not engage in, or give the appearance of, practicing psychology independently of the supervisor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Recordkeeping."> <paragraph num="A."> <text>The recordkeeping requirements of this regulation are in addition to the recordkeeping requirements in COMAR 10.36.05.</text> </paragraph> <paragraph num="B."> <text>Supervisory Sessions.</text> <paragraph num="(1)"> <text>A supervisor and registered psychology associate shall maintain appropriate documentation of the nature and extent of the supervision provided or delegated, including the:</text> <paragraph num="(a)"> <text>Dates and duration of supervisory sessions;</text> </paragraph> <paragraph num="(b)"> <text>Client names or other identification for all cases;</text> </paragraph> <paragraph num="(c)"> <text>Outcome of each case reviewed;</text> </paragraph> <paragraph num="(d)"> <text>Signatures of both the supervisor and registered psychology associate; and</text> </paragraph> <paragraph num="(e)"> <text>Reason for any delegation of supervisory responsibility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A supervisor and registered psychology associate shall provide documentation of supervisory sessions upon request by the Board.</text> </paragraph> <paragraph num="(3)"> <text>Documentation of the supervisory sessions shall be maintained by the supervisor and registered psychology associate for at least 5 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical Records.</text> <paragraph num="(1)"> <text>A registered psychology associate shall have the supervisor co-sign all clinical documents, including:</text> <paragraph num="(a)"> <text>Evaluations;</text> </paragraph> <paragraph num="(b)"> <text>Authorizations for release;</text> </paragraph> <paragraph num="(c)"> <text>Treatment plans; and</text> </paragraph> <paragraph num="(d)"> <text>Report.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as otherwise required, after the initial entry of the supervisor’s name and license number in a client file or medical record, a registered psychology associate may omit repetitive references to the supervisor.</text> </paragraph> <paragraph num="(3)"> <text>Routine entries made by a registered psychology associate do not have to be cosigned by the supervisor, unless failure to do so would result in a misrepresentation of the services provided.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Documentation of site visits shall be maintained by the supervisor and the registered psychology associate for at least 5 years, and shall include:</text> <paragraph num="(1)"> <text>Date and time of visit;</text> </paragraph> <paragraph num="(2)"> <text>Site location; and</text> </paragraph> <paragraph num="(3)"> <text>Any issues or concerns relating to the registered psychology associate’s provision of services at the site.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Board Review and Reporting Requirements."> <paragraph num="A."> <text>The supervisory relationship is subject to review by the Board.</text> </paragraph> <paragraph num="B."> <text>At the time of renewal of the supervisor, the supervisor shall submit to the Board a list of all registered psychology associates supervised by the supervisor on a form approved by the Board that includes the beginning and ending dates of supervision for each registered psychology associate:</text> <paragraph num="(1)"> <text>Supervised during the previous licensure period; and</text> </paragraph> <paragraph num="(2)"> <text>Currently being supervised.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At the time of renewal of the registered psychology associate, the registered psychology associate shall submit to the Board the name and license number of any supervisors who provided supervision to the registered psychology associate:</text> <paragraph num="(1)"> <text>During the previous registration period; and</text> </paragraph> <paragraph num="(2)"> <text>During the present registration period.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisor and registered psychology associate shall immediately report to the Board in writing the date of termination of the supervisory relationship.</text> </paragraph> <paragraph num="E."> <text>A registered psychology associate shall immediately report in writing to the Board any change of supervisor or addition of a supervisor.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§18-101, 18-206, and 18-301, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 25, 1995 (22:19 Md. R. 1473)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05 — .07 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 21, 2011 (38:6 Md. R. 395)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .07 repealed and new Regulations .01 — .06 adopted effective May 25, 2015 (42:10 Md. R. 684)</annotation> </annotations> </chapter> <chapter num="08" heading="Disciplinary Sanctions, Monetary Penalties, and Civil Fines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of sanctions and monetary penalties for violations of the Maryland Psychologists Act.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(2)"> <text>“License” means a license issued by the Board to practice psychology.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means a psychologist who is licensed by the Board to practice psychology.</text> </paragraph> <paragraph num="(4)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(5)"> <text>“Registrant” means a psychology associate who is registered by the Board to practice psychology under the supervision of a licensed psychologist.</text> </paragraph> <paragraph num="(6)"> <text>“Registration” means a registration issued by the Board to practice psychology under the supervision of a licensed psychologist.</text> </paragraph> <paragraph num="(7)"> <text>“Sanction” means a formal disciplinary action against a license such as a reprimand, probation, suspension, or revocation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty After a Hearing."> <text>If the Board finds that there are grounds under Health Occupations Article, §18-313, Annotated Code of Maryland, to suspend or revoke a license or registration or to reprimand a licensee or registrant, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="A."> <text>Instead of suspending the license or registration; or</text> </paragraph> <paragraph num="B."> <text>In addition to suspending or revoking the license or registration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions and Imposition of Penalties."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose sanctions and penalties for violations of the Maryland Psychologists Act and its regulations according to the guidelines set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a licensee or registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this regulation, in order to resolve a pending disciplinary action, the Board and licensee or registrant may agree to a surrender of a license or registration or to a consent order with terms, sanction, and penalty agreed to by the Board and the licensee or registrant.</text> </paragraph> <paragraph num="D."> <text>A departure from the guidelines set forth in this regulation alone is not grounds for any hearing or appeal of a Board action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction."> <paragraph num="A."> <text>Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>The licensee’s or registrant’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The licensee or registrant self-reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The licensee’s or registrant’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>Timely good-faith effort to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to public or adverse impact;</text> </paragraph> <paragraph num="(i)"> <text>The licensee’s or registrant’s conduct was an isolated incident and not likely to recur; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>The licensee or registrant has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The licensee or registrant was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the patient or patients;</text> </paragraph> <paragraph num="(g)"> <text>The licensee or registrant lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(h)"> <text>The licensee or registrant committed the violation under the guise of treatment; and</text> </paragraph> <paragraph num="(i)"> <text>Previous attempts at rehabilitation of the licensee or registrant were unsuccessful.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="C."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of a Penalty."> <paragraph num="A."> <text>A licensee or registrant shall pay to the Board a penalty imposed under this chapter as of the date the Board’s order is issued, unless the Board’s order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §18-316, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee or registrant fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license or registration until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Civil Fines."> <paragraph num="A."> <text>Practicing on an Expired License or Registration.</text> <paragraph num="(1)"> <text>The Board may impose a civil fine against a psychologist or psychology associate who practices psychology on an expired license or registration in the amount of $100 per day of practice past the expiration date of the license or registration.</text> </paragraph> <paragraph num="(2)"> <text>The Board may not impose a fine under §A(1) of this regulation against a psychologist or psychology associate for practicing psychology on an expired license or registration if the psychologist’s license or the psychology associate’s registration is reinstated within 30 calendar days of the expiration date of the license or registration and the licensee or registrant complies with COMAR 10.36.02.08B.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Practicing Without a License or Registration.</text> <paragraph num="(1)"> <text>The Board may impose a civil fine of no less than $5,000 and no more than $50,000 against an individual who practices psychology without a license or registration.</text> </paragraph> <paragraph num="(2)"> <text>Factors determining the amount of the fine shall include, but not be limited to, the following:</text> <paragraph num="(a)"> <text>The extent to which the individual derived any financial benefit from the unauthorized practice;</text> </paragraph> <paragraph num="(b)"> <text>The willfullness of the unauthorized practice;</text> </paragraph> <paragraph num="(c)"> <text>Actual or potential harm caused by the unauthorized practice; and</text> </paragraph> <paragraph num="(d)"> <text>The length of time in which the individual engaged in the unauthorized practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 18-313, 18-313.1, and 18-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 2, 2000 (27:19 Md. R. 1726</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .06 repealed and new Regulations .01 — .06 adopted effective February 20, 2012 (39:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E repealed effective March 17, 2014 (41:5 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective March 17, 2014 (41:5 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684)</annotation> </annotations> </chapter> <chapter num="09" heading="Child Custody Evaluations in Family Law Proceedings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the professional conduct of licensed psychologists who are performing child custody evaluations or who otherwise render an opinion on legal or physical custody.</text> </paragraph> <paragraph num="B."> <text>This chapter is not intended to negate the psychologist’s obligations to comply with other provisions of this subtitle.</text> </paragraph> <paragraph num="C."> <text>This chapter does not apply to the following types of proceedings:</text> <paragraph num="(1)"> <text>Child in need of assistance (CINA) proceedings in accordance with Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Department of Juvenile Services proceedings in accordance with Courts and Judicial Proceedings Article, Title 3, Subtitle 8A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>Termination of parental rights (TPR) proceedings in accordance with Family Law Article, Title 5, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Child” means an individual younger than 18 years old.</text> </paragraph> <paragraph num="(2)"> <text>“Child custody evaluation” means an assessment performed by a psychologist in order to render findings and recommendations regarding custody or visitation that are in the best interest of a child.</text> </paragraph> <paragraph num="(3)"> <text>“Child Custody Proceeding” means a proceeding in which legal custody, physical custody, or visitation with respect to a child is an issue.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Preparing for a Child Custody Evaluation."> <text>Before performing a child custody evaluation, a psychologist shall:</text> <paragraph num="A."> <text>Obtain a copy of:</text> <paragraph num="(1)"> <text>The court order; or</text> </paragraph> <paragraph num="(2)"> <text>An agreement signed by the parties;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Review the scope of the evaluation as defined by the court’s order or the signed agreement and insure that the order or agreement is consistent with the provisions of this chapter; and</text> </paragraph> <paragraph num="C."> <text>Obtain the necessary signed informed consent from the parties, which shall include:</text> <paragraph num="(1)"> <text>The scope of the custody evaluation;</text> </paragraph> <paragraph num="(2)"> <text>The process for conducting the child custody evaluation;</text> </paragraph> <paragraph num="(3)"> <text>Limits to confidentiality;</text> </paragraph> <paragraph num="(4)"> <text>The basis and rate of fees and expenses for which the client will be responsible; and</text> </paragraph> <paragraph num="(5)"> <text>The timeline on which payments are due to the psychologist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Competence Necessary to Conduct Child Custody Evaluations."> <paragraph num="A."> <text>To be considered competent to conduct child custody evaluations, a psychologist shall have education, training, experience, or supervision in the following areas:</text> <paragraph num="(1)"> <text>Child and adult development and psychopathology;</text> </paragraph> <paragraph num="(2)"> <text>Family dynamics and psychopathology, including the impact of divorce;</text> </paragraph> <paragraph num="(3)"> <text>Maryland law governing:</text> <paragraph num="(a)"> <text>Divorce;</text> </paragraph> <paragraph num="(b)"> <text>Child custody proceedings;</text> </paragraph> <paragraph num="(c)"> <text>Child abuse and neglect; and</text> </paragraph> <paragraph num="(d)"> <text>Family violence; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Performing psychological assessments of:</text> <paragraph num="(a)"> <text>Children;</text> </paragraph> <paragraph num="(b)"> <text>Adults; and</text> </paragraph> <paragraph num="(c)"> <text>Families.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A psychologist conducting a child custody evaluation shall have competence to effectively address common issues that may arise in conducting child custody evaluations such as:</text> <paragraph num="(1)"> <text>Age;</text> </paragraph> <paragraph num="(2)"> <text>Disability;</text> </paragraph> <paragraph num="(3)"> <text>Ethnicity;</text> </paragraph> <paragraph num="(4)"> <text>Gender;</text> </paragraph> <paragraph num="(5)"> <text>Gender identity;</text> </paragraph> <paragraph num="(6)"> <text>Language;</text> </paragraph> <paragraph num="(7)"> <text>National origin;</text> </paragraph> <paragraph num="(8)"> <text>Race;</text> </paragraph> <paragraph num="(9)"> <text>Religion;</text> </paragraph> <paragraph num="(10)"> <text>Culture;</text> </paragraph> <paragraph num="(11)"> <text>Sexual orientation; and</text> </paragraph> <paragraph num="(12)"> <text>Socioeconomic status.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A psychologist shall have an awareness of the literature relevant to conducting child custody evaluations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standards of Practice in Conducting a Child Custody Evaluation."> <paragraph num="A."> <text>In order to determine legal and physical custody arrangements that serve the child’s best interests, a psychologist conducting a child custody evaluation shall:</text> <paragraph num="(1)"> <text>Assess the following:</text> <paragraph num="(a)"> <text>Parenting skills and capacities of the adults; and</text> </paragraph> <paragraph num="(b)"> <text>The child’s psychological functioning and developmental needs;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Use multiple methods of data gathering, including, but not limited to:</text> <paragraph num="(a)"> <text>Individually interviewing and assessing each party and each child, if age appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Observing the interactions of the child with each parental figure, in the respective households, whenever possible; and</text> </paragraph> <paragraph num="(c)"> <text>Requesting and assessing additional relevant information whenever possible, such as:</text> <paragraph num="(i)"> <text>Third-party interviews;</text> </paragraph> <paragraph num="(ii)"> <text>Medical records;</text> </paragraph> <paragraph num="(iii)"> <text>School records; and</text> </paragraph> <paragraph num="(iv)"> <text>Legal documents;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Remain impartial and objective;</text> </paragraph> <paragraph num="(4)"> <text>Interpret assessment data and clinical information in a manner consistent with current standards of practice;</text> </paragraph> <paragraph num="(5)"> <text>Base recommendations on the needs and best interests of the child, as supported by the:</text> <paragraph num="(a)"> <text>Evaluation data; and</text> </paragraph> <paragraph num="(b)"> <text>Applicable law;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Create and maintain professional records in accordance with COMAR 10.36.05;</text> </paragraph> <paragraph num="(7)"> <text>Include appropriate disclaimers regarding the limitations of the recommendations, such as:</text> <paragraph num="(a)"> <text>Unavailability of information;</text> </paragraph> <paragraph num="(b)"> <text>Lack of cooperation of the parties;</text> </paragraph> <paragraph num="(c)"> <text>Lack of compliance with court orders; or</text> </paragraph> <paragraph num="(d)"> <text>Inconclusive assessment data; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Decline to conduct the evaluation as set forth in COMAR 10.36.05 if the psychologist feels that the psychologist’s objectivity would be impaired.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In the event a psychologist determines sufficient information is not available, the psychologist may decline to make recommendations.</text> </paragraph> <paragraph num="C."> <text>A psychologist performing a child custody evaluation may not:</text> <paragraph num="(1)"> <text>Engage in multiple relationships with any of the parties to the pending child custody proceeding, including serving as a:</text> <paragraph num="(a)"> <text>Mediator;</text> </paragraph> <paragraph num="(b)"> <text>Therapist;</text> </paragraph> <paragraph num="(c)"> <text>Life coach;</text> </paragraph> <paragraph num="(d)"> <text>Parenting coordinator; or</text> </paragraph> <paragraph num="(e)"> <text>Litigation consultant; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Render an opinion concerning the psychological functioning or custodial fitness of a individual involved in the custody proceeding who has not been personally evaluated by the psychologist during the current child custody evaluation.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §18-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 22, 2011 (38:17 Md. R. 1013)</annotation> </annotations> </chapter> <chapter num="10" heading="Telepsychology"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all psychologists and psychology associates in Maryland who engage in the practice of psychology using telepsychology.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Examiners of Psychologists.</text> </paragraph> <paragraph num="(2)"> <text>“Client” means the individual, couple, family, group, business, agency, school, organization, or association that the psychologist or psychology associate provides, or has provided, with professional services.</text> </paragraph> <paragraph num="(3)"> <text>“Psychologist” means an individual who is licensed by the Board to practice psychology.</text> </paragraph> <paragraph num="(4)"> <text>“Psychology associate” means an individual who is registered by the Board to practice psychology under the supervision of a licensed psychologist.</text> </paragraph> <paragraph num="(5)"> <text>Telepsychology.</text> <paragraph num="(a)"> <text>“Telepsychology” means the use of interactive audio, video, or other telecommunications or electronic media by a psychologist or psychology associate who engages in the practice of psychology at a location other than the location of the client.</text> </paragraph> <paragraph num="(b)"> <text>“Telepsychology” does not include:</text> <paragraph num="(i)"> <text>An audio-only telephone conversation between a psychologist or psychology associate and a client;</text> </paragraph> <paragraph num="(ii)"> <text>An electronic mail message between a psychologist or psychology associate and a client;</text> </paragraph> <paragraph num="(iii)"> <text>A facsimile transmission between a psychologist or psychology associate and a client; or</text> </paragraph> <paragraph num="(iv)"> <text>A text message or other type of message sent between a psychologist or psychology associate and a client by a short message service or multimedia messaging service.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>An individual shall be licensed with the Board as a psychologist or registered with the Board as a psychology associate in order to engage in the practice of psychology using telepsychology in Maryland if one or both of the following occurs:</text> <paragraph num="A."> <text>The individual practicing telepsychology is physically located in Maryland: or</text> </paragraph> <paragraph num="B."> <text>The client is in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telepsychology."> <paragraph num="A."> <text>Before providing telepsychology services, a psychologist or psychology associate shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the client receiving telepsychology services;</text> </paragraph> <paragraph num="(2)"> <text>Obtain informed consent specific to telepsychology services using appropriate language understandable to the client;</text> </paragraph> <paragraph num="(3)"> <text>Prevent access to data by unauthorized persons through encryption, or other means;</text> </paragraph> <paragraph num="(4)"> <text>Notify clients in the event of a data breach;</text> </paragraph> <paragraph num="(5)"> <text>Ensure that the telepsychology practitioner provides a secure and private telepsychology connection and complies with federal and state privacy laws;</text> </paragraph> <paragraph num="(6)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location; and</text> </paragraph> <paragraph num="(7)"> <text>Ensure that any psychological testing instruments used are designed, validated, or appropriate for use via telepsychology.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A psychologist or psychology associate shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Determine whether the client is in Maryland and identify the client’s specific location;</text> </paragraph> <paragraph num="(3)"> <text>For an initial telepsychology interaction only, disclose the psychologist’s or psychology associate’s name, location, license number, and contact information;</text> </paragraph> <paragraph num="(4)"> <text>Identify all individuals present at each location and confirm they are permitted to hear the client’s health information; and</text> </paragraph> <paragraph num="(5)"> <text>Be held to the same standards of practice and documentation as those applicable for in-person sessions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A psychologist or psychology associate may not treat a client based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Evaluation for Telepsychology Services."> <paragraph num="A."> <text>Before engaging in the practice of psychology using telepsychology, a psychologist or psychology associate shall evaluate the client to determine that delivery of telepsychology is appropriate considering at least the following factors:</text> <paragraph num="(1)"> <text>The client’s:</text> <paragraph num="(a)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(b)"> <text>Symptoms;</text> </paragraph> <paragraph num="(c)"> <text>Medical and psychological history; and</text> </paragraph> <paragraph num="(d)"> <text>Preference for receiving services via telepsychology; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The nature of the services to be provided, including anticipated:</text> <paragraph num="(a)"> <text>Benefits;</text> </paragraph> <paragraph num="(b)"> <text>Risks; and</text> </paragraph> <paragraph num="(c)"> <text>Constraints resulting from their delivery via telepsychology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The client evaluation set forth in §A of this regulation shall take place at an initial in-person session, unless the psychologist or psychology associate documents in the record the reason for not meeting in person.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Discipline."> <paragraph num="A."> <text>The Board shall use the same standards in evaluating and investigating a complaint and disciplining a psychologist or psychology associate who practices telepsychology as it would use for a psychologist or psychology associate who does not use telepsychology technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a psychologist or psychology associate to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-901—1-903, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 20, 2019 (46:10 Md. R. 489)</annotation> </annotations> </chapter> </subtitle> <subtitle num="37" heading="Health Services Cost Review Commission"> <chapter num="01" heading="Uniform Accounting and Reporting System for Hospitals and Related Institutions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accounting and Reporting System for Hospitals” means the system originally adopted by the Commission in 1973 and as amended which is in effect at the time the System is referred to in these regulations. The System is also referred to as “the Rate Review System”, or “the Accounting and Budget Manual for Fiscal and Operating Management”.</text> </paragraph> <paragraph num="(2)"> <text>“Beneficial owner” means that person who ultimately benefits or suffers losses from the operation of the firm or has a vested interest in it, and includes, but is not limited to, limited partners, beneficiaries of voting or other trusts, and limited term and remaindermen beneficiaries or owners.</text> </paragraph> <paragraph num="(3)"> <text>“Firm” means a partnership, corporation or other business professional, or academic entity, and, in the case of sole proprietors or practitioners, the trustee himself.</text> </paragraph> <paragraph num="(4)"> <text>“Notify in writing” or “written notification” means personal delivery to the person to be notified, or mailing through the United States Postal Services, by registered or certified mail, return receipt requested to the person to be notified.</text> </paragraph> <paragraph num="(5)"> <text>“Officer” means:</text> <paragraph num="(a)"> <text>An individual who is elected to office pursuant to a resolution of the governing board of the hospital or related institution, to fill a position defined in the bylaws of the hospital or related institution; or</text> </paragraph> <paragraph num="(b)"> <text>An individual who, although not specifically designated as an “officer” administers the policies of the hospital or related institution, and has the authority and performs the duties in the management of the property and affairs of the hospital or related institution as may be provided in the bylaws.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Partner” means any partner who has voting power or management or policy responsibilities, regardless of restrictions thereon, but excludes limited partners or other partners who have no vote in or management or policy responsibilities as to the partnership.</text> </paragraph> <paragraph num="(7)"> <text>“Section 556 hospitals” or “hospitals” means all hospitals as defined in Article 43, §556, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Section 556 nursing homes” or “nursing homes” or “Section 556 care homes” or “care homes” means all nursing homes or care homes as defined in Article 43, §556, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Section 556 related institutions” or “related institutions” means all related institutions as defined in Article 43, §556, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Trustee" or "director” means any person serving on a governing board or committee of a nonprofit hospital or related institution who is empowered to vote on matters concerning the hospital's or related institution's governance or other matters generally concerning its policies.</text> </paragraph> <paragraph num="(11)"> <text>“Willfully” means acting in a purposeful and not a negligent or accidental manner, but need not encompass a criminal intent not to observe or to breach any statute or rule of law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Accounting System; Hospitals."> <paragraph num="A."> <text>The Accounting System.</text> <paragraph num="(1)"> <text>The accounting system set forth in the Commission's "Accounting and Reporting System for Hospitals” first issued in February, 1973, shall be used by all hospitals under the jurisdiction of the Commission for their fiscal year period beginning on or after April 1, 1973, and all subsequent periods.</text> </paragraph> <paragraph num="(2)"> <text>The “Accounting and Reporting Systems for Hospitals”, also known as the Accounting and Budget Manual for Fiscal and Operating Management (October 1, 2024) is incorporated by reference.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide each hospital under its jurisdiction with a copy of the most recently updated Accounting and Budget Manual for Fiscal and Operating Management, which shall represent the official interpretation of accounting and reporting practices and procedures of the System.</text> </paragraph> <paragraph num="(4)"> <text>The Executive Director is authorized and empowered by the Commission to allocate specific items to specific accounts within the system when the allocations are necessary to assume uniformity of accounting procedures. Furthermore, any proposed technical changes to the Accounting and Budget Manual will be posted on the HSCRC website for public comment. Technical changes mean non-substantive, revenue neutral updates.</text> </paragraph> <paragraph num="(5)"> <text>Requests for exceptions to the system may be filed as provided in §C.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Accrual Accounting.</text> <paragraph num="(1)"> <text>A full accrual basis of accounting for revenue and expenses is required.</text> </paragraph> <paragraph num="(2)"> <text>Revenues shall be given recognition in the period during which the service is provided.</text> </paragraph> <paragraph num="(3)"> <text>Revenue shall be recorded at the full established rates regardless of the amounts actually paid to the hospital or on behalf of the patients.</text> </paragraph> <paragraph num="(4)"> <text>Revenue deductions shall be given accounting recognition in the same period that the related revenues are recorded.</text> </paragraph> <paragraph num="(5)"> <text>Expenses shall be given recognition in the period in which there is:</text> <paragraph num="(a)"> <text>A direct identification or association with revenue, as in the case of services rendered to patients;</text> </paragraph> <paragraph num="(b)"> <text>An indirect association with revenue, as in the case of salaries or rent; or</text> </paragraph> <paragraph num="(c)"> <text>A measurable expiration of asset costs even though not associated with the production of revenue for the current period as in the loss from fire.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Requests for Exceptions to System Manual.</text> <paragraph num="(1)"> <text>As provided by Health-General Article, §19-211(b), hospitals may file a written request for exception with the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director shall respond in writing promptly to the requesting hospital on receipt of the request acknowledging its receipt and providing the requesting hospital with a date by which the request shall be answered.</text> </paragraph> <paragraph num="(3)"> <text>If needed for evaluation of the request, the Executive Director will seek additional information from the appropriate source.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Review of Denial of Request for Exception.</text> <paragraph num="(1)"> <text>Any hospital denied an exception to the accounting system or manual may file a written petition to the Commission for a hearing to review the action of the Executive Director in refusing its request for exception.</text> </paragraph> <paragraph num="(2)"> <text>A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the aggrieved hospital was notified in writing of the action taken on the requested exception, and shall state the grounds for the petition.</text> </paragraph> <paragraph num="(3)"> <text>A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commissioners chosen by the Chairman for that purpose.</text> </paragraph> <paragraph num="(4)"> <text>The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions.</text> </paragraph> <paragraph num="(5)"> <text>Promptly after the hearing, the subcommittee shall report to the Commission, which shall make its decision within 45 days of the submission of the petition to review.</text> </paragraph> <paragraph num="(6)"> <text>The decision of a majority of the Commission, which shall be recorded in the form of a written decision filed with the Commission's office, shall be final, subject to the right of appeal in accordance with Health-General Article, §19-221.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reporting Requirements; Hospitals."> <paragraph num="A."> <text>Annual Financial Statements.</text> <paragraph num="(1)"> <text>The following audited financial statements are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Balance Sheet—Unrestricted Funds (AUB);</text> </paragraph> <paragraph num="(b)"> <text>Balance Sheet—Restricted Funds (ARB);</text> </paragraph> <paragraph num="(c)"> <text>Statement of Change in Equity (AFB);</text> </paragraph> <paragraph num="(d)"> <text>Statement of Revenue and Expense (ARE);</text> </paragraph> <paragraph num="(e)"> <text>Statement of Change in Financial Position (AFP).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The above reports shall be recorded on the basis of actual data and be submitted within 90 days after the end of each hospital's fiscal year.</text> </paragraph> <paragraph num="(3)"> <text>Report AUB, ARB, AFB, ARE, and AFP as required above shall include attests by the institution's certified public accountants.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Monthly Financial Statements.</text> <paragraph num="(1)"> <text>The following unaudited financial statements are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Balance Sheet—Unrestricted Funds (QUB);</text> </paragraph> <paragraph num="(b)"> <text>Balance Sheet—Restricted Funds (QRB);</text> </paragraph> <paragraph num="(c)"> <text>Statement of Revenues and Expenses (QRE).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The above reports shall be recorded on the basis of actual data and be submitted within 30 days after the end of each month of the calendar year.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Monthly Financial Statement Summary.</text> <paragraph num="(1)"> <text>The following unaudited monthly financial statement summary is required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: Financial Statement Summary—(FS).</text> </paragraph> <paragraph num="(2)"> <text>Schedule FS shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="(3)"> <text>Schedule FS is to be submitted within 30 days after the end of each month of the calendar year in the format prescribed by the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Monthly Reports of Achieved Volumes and Revenues.</text> <paragraph num="(1)"> <text>The following monthly volume and revenue reports are required to be submitted by each hospital under the jurisdiction of the Commission, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Statistical Data and Revenue Summary — Daily Hospital Services;</text> </paragraph> <paragraph num="(b)"> <text>Statistical Data and Revenue Summary — Ambulatory Services and Admissions Services;</text> </paragraph> <paragraph num="(c)"> <text>Statistical Data and Revenue Summary — Ancillary Services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Monthly Reports of Achieved Volumes and Revenues shall be completed on the basis of actual data in the format prescribed by the Commission.</text> </paragraph> <paragraph num="(3)"> <text>The Monthly Reports of Achieved Volumes and Revenues shall be submitted within 30 days after the end of each month of the calendar year in the format prescribed by the Commission.</text> </paragraph> <paragraph num="(4)"> <text>The Monthly Reports of Achieved Volumes and Revenues submitted under this section shall be made in the format as published in the Maryland Register and on the Commission’s website (http://www.hscrc.maryland.gov).</text> </paragraph> </paragraph> <paragraph num="E."> <text>Annual Report of Revenue and Volume Comparisons.</text> <paragraph num="(1)"> <text>The following annual report of revenue and volume comparisons is required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: Revenue and Volume Comparisons (RVC).</text> </paragraph> <paragraph num="(2)"> <text>Schedule RVC shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="(3)"> <text>Schedule RVC shall be submitted within 90 days after the end of each hospital's fiscal year in the format prescribed by the Commission.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Annual Reports of Revenues, Expenses, and Volumes.</text> <paragraph num="(1)"> <text>The following annual reports of revenues, expenses, and volumes are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Inpatient and Patient Days (V1A, V1B, V1C, V1D);</text> </paragraph> <paragraph num="(b)"> <text>Outpatient Visits (V2A, V2B);</text> </paragraph> <paragraph num="(c)"> <text>Ancillary Service Units (V3A, V3D);</text> </paragraph> <paragraph num="(d)"> <text>Equivalent Inpatient Days and Admissions (V5);</text> </paragraph> <paragraph num="(e)"> <text>Allocation of Data Processing (DP1);</text> </paragraph> <paragraph num="(f)"> <text>Unassigned Expense (UA);</text> </paragraph> <paragraph num="(g)"> <text>Hospital Based Physicians (P1A, P1B);</text> </paragraph> <paragraph num="(h)"> <text>Medical Staff Services (P2A to P2I);</text> </paragraph> <paragraph num="(i)"> <text>Physical Support Services (P3A to P3H);</text> </paragraph> <paragraph num="(j)"> <text>Residents, Interns Services—Eligible (P4A to P4I);</text> </paragraph> <paragraph num="(k)"> <text>Residents, Interns Services—Ineligible (P5A to P5I);</text> </paragraph> <paragraph num="(l)"> <text>Overhead Expense Summary (OES);</text> </paragraph> <paragraph num="(m)"> <text>General Service Center (C1 to C14);</text> </paragraph> <paragraph num="(n)"> <text>Patient Care Center (D1 to D81);</text> </paragraph> <paragraph num="(o)"> <text>Auxiliary Enterprises (E1 to E9);</text> </paragraph> <paragraph num="(p)"> <text>Other Institutional Programs (F1 to F4);</text> </paragraph> <paragraph num="(q)"> <text>Allocation of Cafeteria, Parking, Etc. (OAA to OAK);</text> </paragraph> <paragraph num="(r)"> <text>Reconciliation of Base Year Expenses to Schedule RE (RC);</text> </paragraph> <paragraph num="(s)"> <text>Statement of Revenue and Expenses (RE);</text> </paragraph> <paragraph num="(t)"> <text>Overhead Expense Apportionment (J1 to J4);</text> </paragraph> <paragraph num="(u)"> <text>Overhead Statistical Apportionment (J51 to J54);</text> </paragraph> <paragraph num="(v)"> <text>Building Facility Allowance (H1);</text> </paragraph> <paragraph num="(w)"> <text>Departmental Equipment Allowance (H2A to H2Y);</text> </paragraph> <paragraph num="(x)"> <text>Distribution of Capital Facilities Allowances (H3A to H3D);</text> </paragraph> <paragraph num="(y)"> <text>Capital Facility Allowance Summary (H4);</text> </paragraph> <paragraph num="(z)"> <text>Cash and Marketable Assets (GR);</text> </paragraph> <paragraph num="(aa)"> <text>Payor Differential (PDA);</text> </paragraph> <paragraph num="(bb)"> <text>MB Revenue (M, MA, MB);</text> </paragraph> <paragraph num="(cc)"> <text>Unregulated Services (UR1 to UR6);</text> </paragraph> <paragraph num="(dd)"> <text>Operating Room Survey (ORS);</text> </paragraph> <paragraph num="(ee)"> <text>Other Financial Considerations (G);</text> </paragraph> <paragraph num="(ff)"> <text>Annual Cost Survey (ACS);</text> </paragraph> <paragraph num="(gg)"> <text>Transactions with Related Entities (TRE);</text> </paragraph> <paragraph num="(hh)"> <text>Revenue and Volume Comparisons (RVC);</text> </paragraph> <paragraph num="(ii)"> <text>Schedule D Personnel Schedules (PH1 to PH2);</text> </paragraph> <paragraph num="(jj)"> <text>Utilization of Therapies (TU).</text> </paragraph> <paragraph num="(kk)"> <text>Mandated Trauma Cost (MTC); and</text> </paragraph> <paragraph num="(ll)"> <text>Stand-By Costs (SBC).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The above annual reports of revenues, expenses, and volumes shall be completed on the basis of actual data and certain projected data in the form prescribed by the Commission in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="(3)"> <text>The above annual reports of revenues, expenses, and volumes shall be submitted within 90 days after the end of each hospital's fiscal year in the format prescribed by the Commission.</text> </paragraph> <paragraph num="(4)"> <text>Collection and Submission of Data. Upon the effective date of this regulation, each hospital under the jurisdiction of the Health Services Cost Review Commission shall submit the following data elements relative to bad debts and uncompensated care in accordance with the instructions detailed in the Accounting and Budget Manual:</text> <paragraph num="(a)"> <text>Inpatient uncompensated care and bad debts;</text> </paragraph> <paragraph num="(b)"> <text>Outpatient uncompensated care and bad debts.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Repealed.</text> </paragraph> <paragraph num="H."> <text>Special Audit.</text> <paragraph num="(1)"> <text>An audit of various data submitted in the Annual Reports of Revenues, Expenses, and Volumes, Wage and Salary Survey, and the Annual Report of Change in Building and Equipment Fund Balances is required to be performed by the independent certified public accounting firm of each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>The audit procedures shall be completed in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="(3)"> <text>The results of the audit shall be submitted to the Commission within 110 days after the end of each hospital's fiscal year in the format prescribed by the Commission.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Annual Reports of Wage and Salary Survey.</text> <paragraph num="(1)"> <text>The following annual reports of wage and salary survey are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Wage, Salary and Fringe Benefits Summary (WSA, WSB, WSC);</text> </paragraph> <paragraph num="(b)"> <text>Fringe Benefits Calculation (FB).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Schedules WSA, WSB, WSC, and FB shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="(3)"> <text>Schedules WSA, WSB, WSC, and FB shall be submitted by June 1 of every calendar year in the format prescribed by the Commission.</text> </paragraph> <paragraph num="(4)"> <text>The Commission may require the submission of nonpersonally identifiable wage and salary data elements for individual employees.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Rate Review Reports.</text> <paragraph num="(1)"> <text>The following rate review reporting schedules are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health:</text> <paragraph num="(a)"> <text>Inpatient and Patient Days (V1A, V1B, V1C, V1D);</text> </paragraph> <paragraph num="(b)"> <text>Outpatient Visits (V2A, V2B);</text> </paragraph> <paragraph num="(c)"> <text>Ancillary Service Units (V3A, V3D);</text> </paragraph> <paragraph num="(d)"> <text>Equivalent Inpatient Days and Admissions (V5);</text> </paragraph> <paragraph num="(e)"> <text>Allocation of Data Processing (DP1);</text> </paragraph> <paragraph num="(f)"> <text>Unassigned Expense (UA);</text> </paragraph> <paragraph num="(g)"> <text>Hospital Based Physicians (P1A, P1B);</text> </paragraph> <paragraph num="(h)"> <text>Medical Staff Services (P2A to P2I);</text> </paragraph> <paragraph num="(i)"> <text>Physician Support Services (P3A to P3H);</text> </paragraph> <paragraph num="(j)"> <text>Residents, Interns Services—Eligible (P4A to P4I);</text> </paragraph> <paragraph num="(k)"> <text>Residents, Interns Services—Ineligible (P5A to P5I);</text> </paragraph> <paragraph num="(l)"> <text>Overhead Expense Summary (OES);</text> </paragraph> <paragraph num="(m)"> <text>General Service Center (C1 to C14);</text> </paragraph> <paragraph num="(n)"> <text>Patient Care Center (D1 to D81);</text> </paragraph> <paragraph num="(o)"> <text>Auxiliary Enterprises (E1 to E9);</text> </paragraph> <paragraph num="(p)"> <text>Other Institutional Programs (F1 to F4);</text> </paragraph> <paragraph num="(q)"> <text>Allocation of Cafeteria, Parking, etc. (OAA to OAK);</text> </paragraph> <paragraph num="(r)"> <text>Reconciliation of Base Year Expenses to Schedule RE (RC);</text> </paragraph> <paragraph num="(s)"> <text>Statement of Revenue and Expenses (RE);</text> </paragraph> <paragraph num="(t)"> <text>Overhead Expense Apportionment (J1 to J4);</text> </paragraph> <paragraph num="(u)"> <text>Overhead Statistical Apportionment (J51 to J54);</text> </paragraph> <paragraph num="(v)"> <text>Building Facility Allowance (H1);</text> </paragraph> <paragraph num="(w)"> <text>Departmental Equipment Allowance (H2A to H2Y);</text> </paragraph> <paragraph num="(x)"> <text>Distribution of Capital Facilities Allowances (H3A to H3D);</text> </paragraph> <paragraph num="(y)"> <text>Capital Facility Allowance Summary (H4);</text> </paragraph> <paragraph num="(z)"> <text>Cash and Marketable Assets (GR);</text> </paragraph> <paragraph num="(aa)"> <text>Payor Differential (PDA);</text> </paragraph> <paragraph num="(bb)"> <text>MB Revenue Centers (M, MA, MB);</text> </paragraph> <paragraph num="(cc)"> <text>Unregulated Services (UR1 to UR6);</text> </paragraph> <paragraph num="(dd)"> <text>Operating Room Survey (ORS);</text> </paragraph> <paragraph num="(ee)"> <text>Other Financial Considerations (G);</text> </paragraph> <paragraph num="(ff)"> <text>Annual Cost Survey (ACS);</text> </paragraph> <paragraph num="(gg)"> <text>Transactions with Related Entities (TRE);</text> </paragraph> <paragraph num="(hh)"> <text>Revenue and Volume Comparisons (RVC);</text> </paragraph> <paragraph num="(ii)"> <text>Schedules D Personnel Schedules (PH1 to PH2);</text> </paragraph> <paragraph num="(jj)"> <text>Utilization of Therapies (TU);</text> </paragraph> <paragraph num="(kk)"> <text>(MTC) Mandated Trauma Cost; and</text> </paragraph> <paragraph num="(ll)"> <text>(SBC) Stand-by Costs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The above review reports shall be completed on the basis of actual data and certain projected data in the form prescribed by the Commission in the “Accounting and Reporting System for Hospitals”.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Interns and Residents Survey.</text> <paragraph num="(1)"> <text>Hospitals shall submit the Interns and Residents Survey to the Commission by January 15 of every calendar year.</text> </paragraph> <paragraph num="(2)"> <text>Hospitals shall complete the survey on the basis of actual data in the form prescribed by the Commission.</text> </paragraph> </paragraph> <paragraph num="L."> <text>General Assembly Studies and Other Reports. The Commission may require hospitals to submit information in response to information required of the Commission by the Maryland General Assembly.</text> </paragraph> <paragraph num="M."> <text>Annual Nonprofit Hospital Community Benefit Report.</text> <paragraph num="(1)"> <text>Beginning on December 15, 2009, each nonprofit hospital shall submit the Annual Nonprofit Hospital Community Benefit Report to the Commission by the date prescribed by the Commission in the format prescribed by the Commission.</text> </paragraph> <paragraph num="(2)"> <text>Hospitals shall complete the report on the basis of actual data covering the reporting period of the previous July 1 through June 30 or other time period as specified by the Commission.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide instructions for completing the report on its public website.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Internal Revenue Service Form 990. Beginning on October 1, 2009, each nonprofit hospital shall submit its most recent Form 990 that the facility filed with the Internal Revenue Service within 30 days from the Internal Revenue Service filing.</text> </paragraph> <paragraph num="O."> <text>Annual Debt Collection Report.</text> <paragraph num="(1)"> <text>Hospitals shall submit the Annual Debt Collection Report to the Commission within 60 days after the end of each hospital’s fiscal year.</text> </paragraph> <paragraph num="(2)"> <text>Hospitals shall complete the report on the basis of actual data in the form prescribed by the Commission.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide instructions for completing the report in its Accounting and Budget Manual for Fiscal and Operating Management.</text> </paragraph> </paragraph> <paragraph num="P."> <text>All-Payer Model Agreement Data Requirements. Hospitals shall submit data in accordance with the requirements of the January 1, 2014 All-Payer Model Agreement executed between the State of Maryland and the Center for Medicare and Medicaid Innovation for evaluation purposes.</text> </paragraph> <paragraph num="Q."> <text>Report Format Changes. The Commission, after consideration at a public meeting or other public forum, may modify the reporting requirements of the above reports as it deems necessary, if reasonable notice is given to each hospital under its jurisdiction and all designated interested parties using the “Accounting and Reporting System for Hospitals”.</text> </paragraph> <paragraph num="R."> <text>Failure to File Reports.</text> <paragraph num="(1)"> <text>A hospital under the jurisdiction of the Commission which does not file any report under the Enabling Act of the Commission, Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland, or under the regulations of the Commission, is liable for a civil penalty of up to $1,000 per day for each day the filing of the report is delayed unless an extension is granted as provided in §O of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>These fines may not be considered reasonable costs for purposes of rate setting by the Commission.</text> </paragraph> <paragraph num="(3)"> <text>The Commission may refuse to grant a rate increase to any hospital which does not file a report required under its enabling legislation (Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland) or its regulations.</text> </paragraph> <paragraph num="(4)"> <text>Any required report submitted to the Commission which is substantially incomplete or inaccurate may not be considered timely filed. In addition, any incomplete or inaccurate report submitted by a hospital that results in, or will result in, rates which, through the application of normal Commission methodology, vary, or will vary, from the allowed corridors specified in COMAR 10.37.03.05F, may not be considered timely filed.</text> </paragraph> <paragraph num="(5)"> <text>All annual reports required to be filed with the Commission shall contain an attestation by the institution's chief financial officer that, to the best of the officer's information and belief, the reports filed have been prepared in conformity with the Commission's uniform accounting and financial reporting system as set forth in the Manual.</text> </paragraph> <paragraph num="(6)"> <text>All annual reports required to be filed with the Commission shall contain an attestation by the institution's chief executive officer that, to the best of the officer's information and belief, neither the hospital, its related entity, nor any entity or person acting on behalf of or in concert with the hospital knowingly is participating in or receiving the benefit of any fixed price arrangement, directly or indirectly, pertaining to the delivery of hospital services without approval by the Commission.</text> </paragraph> </paragraph> <paragraph num="S."> <text>Requests for Extension of Time to File Required Reports.</text> <paragraph num="(1)"> <text>A Section 556 hospital under the jurisdiction of the Commission may file with the Commission written requests for reasonable extensions of time to file any or all of the required reports.</text> </paragraph> <paragraph num="(2)"> <text>The requests for extensions will be supported by justification for the approval of the extension request.</text> </paragraph> <paragraph num="(3)"> <text>The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request.</text> </paragraph> <paragraph num="(4)"> <text>If it is needed for evaluation of the request, the Executive Director will seek information from the requesting hospital.</text> </paragraph> <paragraph num="(5)"> <text>Requests for extensions shall be made at a reasonable time before the due date of a required report. Extensions will be granted only for valid reasons.</text> </paragraph> <paragraph num="(6)"> <text>In the case of a submission of the Annual Reports of Revenues, Expenses, and Volumes, requests for extensions shall generally be made at least 45 days before the due date. Failure of a hospital to have its audited financial statements completed may generally not constitute a valid reason for an extension.</text> </paragraph> </paragraph> <paragraph num="T."> <text>Review of Denial of Request for Extension.</text> <paragraph num="(1)"> <text>A hospital denied an extension of time under §O may file a written petition with the Commission for a hearing to review the action of the Executive Director in refusing its request for extension.</text> </paragraph> <paragraph num="(2)"> <text>A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the aggrieved hospital was notified in writing of the action with respect to the requested extension and shall state the grounds for the petition.</text> </paragraph> <paragraph num="(3)"> <text>A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for that purpose.</text> </paragraph> <paragraph num="(4)"> <text>The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions.</text> </paragraph> <paragraph num="(5)"> <text>Promptly after the hearing, the subcommittee shall report to the Commission which shall make its decision within 45 days of the submission of the petition to review.</text> </paragraph> <paragraph num="(6)"> <text>The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of review in accordance with Health-General Article, §19-221.</text> </paragraph> </paragraph> <paragraph num="U."> <text>Stay of Charges.</text> <paragraph num="(1)"> <text>Unless the Commission reverses the Executive Director, the filing of a written petition pursuant to §P may not stay the continued accrual of the charges levied under §N against a hospital which fails to meet the deadline for filing reports required in these regulations.</text> </paragraph> <paragraph num="(2)"> <text>If the Commission affirms the decision of the Executive Director, the penalties which accrued during the appeal period may be suspended or reduced by the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Accounting System: Related Institutions."> <paragraph num="A."> <text>The Accounting System.</text> <paragraph num="(1)"> <text>The accounting system set forth in the Commission's “Accounting and Reporting System for Related Institutions” issued in March, 1973, shall be used by all Section 556 related institutions for their fiscal year period beginning on, or after, April 1, 1973, and all subsequent periods.</text> </paragraph> <paragraph num="(2)"> <text>The “Accounting and Reporting System for Related Institutions” is incorporated in these regulations as if set forth in full.</text> </paragraph> <paragraph num="(3)"> <text>The Commission shall provide each section 556 related institution with a copy of “Accounting and Reporting System for Related Institutions” which may be amended pursuant to the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>The Executive Director is authorized and empowered by the Commission to allocate specific items to specific accounts within the System when the allocations are necessary to assure uniformity of accounting procedures.</text> </paragraph> <paragraph num="(5)"> <text>Requests for exceptions to the System may be filed as provided in §D, of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Accrual Accounting.</text> <paragraph num="(1)"> <text>A full accrual basis of accounting for revenue and expenses is required.</text> </paragraph> <paragraph num="(2)"> <text>Revenues shall be given recognition in the period during which the service is provided.</text> </paragraph> <paragraph num="(3)"> <text>Revenues shall be recorded at the full established rates regardless of the amounts actually paid to the related institution by, or on behalf of, the patients.</text> </paragraph> <paragraph num="(4)"> <text>Revenue deductions shall be given accounting recognition in the same period that the related revenues are recorded.</text> </paragraph> <paragraph num="(5)"> <text>Expenses shall be given recognition in the period in which there is:</text> <paragraph num="(a)"> <text>A direct identification or association with revenue, as in the case of services rendered to patients;</text> </paragraph> <paragraph num="(b)"> <text>An indirect association with revenue, as in the case of salaries or rent; or</text> </paragraph> <paragraph num="(c)"> <text>A measurable expiration of asset costs even though not associated with the production of revenue for the current period, as in the case of losses from fire.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Manual.</text> <paragraph num="(1)"> <text>As may be necessary to assure uniformity of accounting and reporting procedures, the Commission may adopt a manual which will be supplemental to the system hereby adopted, to be incorporated in these regulations in the same manner as set forth in §A(2), of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall provide each section 556 related institution with a copy of the manual, which may be amended pursuant to the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Any manual adopted by the Commission shall be the official interpretation of accounting and reporting practices and procedures within the Related Institution Accounting and Reporting System.</text> </paragraph> <paragraph num="(4)"> <text>Requests for exceptions to the manual may be filed as provided in §D, of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Requests for Exceptions to System or Manual.</text> <paragraph num="(1)"> <text>As provided by Health-General Article, §19-211(b), Annotated Code of Maryland, related institutions may file a written request for exception with the Commission.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director shall respond in writing promptly to the requesting related institution on receipt of the request, acknowledging its receipt and providing the requesting related institution with a date by which the request shall be answered.</text> </paragraph> <paragraph num="(3)"> <text>If needed for evaluation of the request, the Executive Director will seek additional information from the appropriate source.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Review of Denial of Request for Exception.</text> <paragraph num="(1)"> <text>Any related institution denied an exception to the accounting system or manual may file a written petition to the Commission for a hearing to review the action of the Executive Director in refusing its request for exception.</text> </paragraph> <paragraph num="(2)"> <text>A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the related institution aggrieved was notified in writing of the action taken on the requested exception and shall state the grounds for the petition.</text> </paragraph> <paragraph num="(3)"> <text>A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for that purpose.</text> </paragraph> <paragraph num="(4)"> <text>The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions.</text> </paragraph> <paragraph num="(5)"> <text>Promptly after the hearing, the subcommittee shall report to the Commission which shall make its decision within 45 days of the submission of the petition to review.</text> </paragraph> <paragraph num="(6)"> <text>The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of appeal in accordance with Health-General Article, §19-221, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reporting Requirements, Related Institutions."> <paragraph num="A."> <text>Required Annual Reports and Statements. Each section 556 related institution shall submit annually to the Commission, within 90 days after the close of the related institution's annual accounting period (fiscal year), the following reports and statements as specified in Section III of Accounting and Reporting System for Related Institutions:</text> <paragraph num="(1)"> <text>A balance sheet (Schedule D);</text> </paragraph> <paragraph num="(2)"> <text>A statistical, cost finding and revenue analysis report (Schedules A, B, and G);</text> </paragraph> <paragraph num="(3)"> <text>A profit and loss statement (Schedule C);</text> </paragraph> <paragraph num="(4)"> <text>Statements of selected data related to owners and related organizations (Schedules E and F);</text> </paragraph> <paragraph num="(5)"> <text>Certification (Schedule H);</text> </paragraph> <paragraph num="(6)"> <text>A statement of its dealings and relationships with certain entities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Report Formats.</text> <paragraph num="(1)"> <text>The required report and statement formats to be used by section 556 related institutions when submitting the annual reports and statements required by §A, of this regulation, are those presented in the Commission's “Accounting and Reporting System for Related Institutions,” except for the statement required under §A(6), of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Nonprofit related institutions shall file a verified statement pursuant to §A(6), of this regulation, setting forth the following information in substantially the following form:</text> </paragraph> <paragraph num="(3)"> <text>Proprietary related institutions shall file a verified statement pursuant to §A(6) setting forth the following information in substantially the following form:</text> </paragraph> </paragraph> <paragraph num="C."> <text>Failure to File Reports.</text> <paragraph num="(1)"> <text>Any section 556 related institution which does not file any report or statement required herein is liable for a civil penalty of $100 per day for each day the filing of the report or statement is delayed unless an extension is granted as provided in §D of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>This penalty may not be considered a part of reasonable costs for purposes of rate setting by the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Requests for Extension of Time to File Required Reports or Statements.</text> <paragraph num="(1)"> <text>Any section 556 related institution may file with the Commission written requests for reasonable extensions of time to file any or all of the required reports or statements.</text> </paragraph> <paragraph num="(2)"> <text>The requests for extensions shall be supported by justification for the approval of the extension requests.</text> </paragraph> <paragraph num="(3)"> <text>The Executive Director shall respond promptly in writing to the requesting related institution upon receipt of the requests by either approving or disapproving the requests.</text> </paragraph> <paragraph num="(4)"> <text>If needed for evaluation of any request, the Executive Director will seek additional information from the requesting related institution.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Review of Denial of Request for Extension.</text> <paragraph num="(1)"> <text>Any related institution denied an extension of time under §D may file a written petition with the Commission for a hearing to review the action of the Executive Director in refusing its request for extension.</text> </paragraph> <paragraph num="(2)"> <text>A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the related institution aggrieved was notified in writing of the action with respect to the requested extension and shall state the grounds for the petition.</text> </paragraph> <paragraph num="(3)"> <text>A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for this purpose.</text> </paragraph> <paragraph num="(4)"> <text>The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospital or related institution.</text> </paragraph> <paragraph num="(5)"> <text>Promptly after the hearing, the subcommittee shall report to the Commission, which shall make its decision within 45 days after the date of the submission of the petition to review.</text> </paragraph> <paragraph num="(6)"> <text>The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of review in accordance with Health-General Article, §19-221, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Stay of Charges.</text> <paragraph num="(1)"> <text>Unless the Commission reverses the action of the Executive Director, the filing of a petition pursuant to §E may stay the continued accrual of the charges levied under §C against a related institution which fails to meet the deadline for filing reports or statements required in these regulations.</text> </paragraph> <paragraph num="(2)"> <text>In cases where the Commission affirms the action of the Executive Director, the penalties which accrued during the appeal may be suspended or reduced by the Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Non-Profit Hospitals and Related Institutions: Disclosure of Interest by Trustees."> <paragraph num="A."> <text>The Guide and Instructions. The Guide for the Trustee's Disclosure of Interest Statement and the instructions for it set forth immediately following these regulations concerning disclosure, are hereby incorporated in these regulations.</text> </paragraph> <paragraph num="B."> <text>Periods Covered by the Statement. The statement shall report all business transactions described in Health-General Article, §19-220, Annotated Code of Maryland, during the hospital's or related institution's fiscal year beginning on, or after, July 1, 1973 and an additional statement shall report business transactions during each succeeding fiscal year of the hospital or related institutions or fraction of that year that the trustee serves the hospital or related institution.</text> </paragraph> <paragraph num="C."> <text>Filing of Statements. The trustee shall file the completed, executed, and verified statement with the Commission within 90 days after the end of the fiscal year to which it applies.</text> </paragraph> <paragraph num="D."> <text>Failure or Delay in Filing Statements.</text> <paragraph num="(1)"> <text>Any trustee who does not file the statement on the date it is due is liable for a civil penalty or fine of $250 per day for each day the filing of the statement is delayed, unless an extension is granted and a stay of filing is granted as provided in §§E, F, and G of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>This penalty or fine may not be considered reasonable costs for purposes of rate setting by the Commission if the hospital or related institution reimburses or indemnifies the trustee therefor in any manner.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Request for Extension of Time to File Statements.</text> <paragraph num="(1)"> <text>A trustee may file with the Commission a written request for a reasonable extension of time to file his statement.</text> </paragraph> <paragraph num="(2)"> <text>The request for extension shall be supported by justification for the approval of the extension request.</text> </paragraph> <paragraph num="(3)"> <text>The Executive Director shall respond promptly in writing to the requesting trustee upon receipt of the request by either approving or disapproving the request.</text> </paragraph> <paragraph num="(4)"> <text>If needed for evaluation of the request, the Executive Director may seek additional information from the requesting trustee, his firm, the hospital or related institution on whose board he serves, or other pertinent sources.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Review of Denial of Request for Extension.</text> <paragraph num="(1)"> <text>Any trustee denied or given an inadequate extension of time under §E, of this regulation, may file a written petition with the Commission to review the action of the Executive Director in refusing his request for extension or giving him an inadequate extension, within 10 days of the date on which the trustee was notified in writing of the action with respect to the requested extension. The petition shall state the grounds for the proposed extension and request a review of the denial of his request for it.</text> </paragraph> <paragraph num="(2)"> <text>A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 20 days of the date on which the petition was filed, before a disclosure subcommittee composed of one or more members of the Commission chosen by the Chairman for that purpose.</text> </paragraph> <paragraph num="(3)"> <text>The disclosure subcommittee shall consist of a majority of persons who have no connection with the management of policy of any hospital or related institution.</text> </paragraph> <paragraph num="(4)"> <text>Promptly after the hearing, the disclosure subcommittee shall report to the Commission which shall render its decision within 30 days of the submission of the petition to review.</text> </paragraph> <paragraph num="(5)"> <text>The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall assess a specific penalty not exceeding the amount of penalty set forth in §D, of this regulation, or state that no penalty is imposed, as set forth in these regulations, and shall be final, subject to the right of review in accordance with Health-General Article, §19-221, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Accrual of Penalty. The filing of a petition pursuant to §F, of this regulation, may not stay the accrual of the penalty imposed pursuant to §D, of this regulation. However, the penalty may not be assessed against or collected from the trustee until the conclusion of the proceeding initiated by the trustee's petition. The penalty may be modified in accordance with the Commission's decision, and the Commission may abate or reduce the penalty as justice and equity may require.</text> </paragraph> <paragraph num="H."> <text>Review, Question, and Substantiation of the Statement.</text> <paragraph num="(1)"> <text>During the 6 months immediately following the filing of each statement, the Commission, after a review of it, may question the statement and require substantiation of facts and matters set forth in it.</text> </paragraph> <paragraph num="(2)"> <text>During the 3 years immediately following the filing of each statement, the Commission, after a review of it, may question the statement as to any relevant fact or matter not set forth in it and require explanations and other disclosures regarding these facts and matters.</text> </paragraph> <paragraph num="(3)"> <text>During the 4 years immediately following the end of each fiscal year of a hospital or related institution, the Commission may question the business transactions between the hospital or related institution and any firm connected as set forth in these regulations with any of the hospital's or related institution's trustees who did not file a statement pertaining to that year.</text> </paragraph> <paragraph num="(4)"> <text>Upon any question by the Commission as set forth in this regulation, the Commission's staff may investigate the questioned situation and hold informal conferences with the trustee in question, or other persons having knowledge of the situation, and hearings may be held on it by the Commission or a subcommittee of the Commission.</text> </paragraph> <paragraph num="(5)"> <text>At informal conferences of the questioned trustee or other persons with the Commission staff, the attendance of persons and the production of specific records, documents, contracts, data, checks, ledgers, or other papers of the trustee, his firm, or the hospital or related institution may be requested, and the Executive Director or his designee may administer oaths or affirmations in the course of statements by any person and in the course of proffers of documents or other papers by the trustee or any person.</text> </paragraph> <paragraph num="(6)"> <text>At hearings held as a result of any questions regarding a trustee's disclosure or lack of disclosure, as set forth in this regulation, the Commission may subpoena witnesses, papers, records, and documents relating to it in the possession of any person, entity, or hospital or related institution.</text> </paragraph> <paragraph num="(7)"> <text>At any time before or during an informal conference held under these regulations, the questioned trustee, if he is scheduled to appear or is present at the conference, or the senior member of the Commission's staff participating in the conference, may request a hearing thereon before the Commission or a subcommittee of the Commission, and this informal conference shall be cancelled or terminated, as the case may be, and a hearing promptly scheduled.</text> </paragraph> <paragraph num="(8)"> <text>Statements, facts, or matters fully set forth in it may not be questioned after 6 months after its filing, and unless the particular trustee is notified in writing of the question by the Commission during the 6-month period, all investigations of it shall cease. However, all questions, investigations, and other actions begun during the 6 month period or which are the subject of notice to the trustee as set forth in this regulation, shall be continued to a proper conclusion.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Information Required of Non-Profit Facilities.</text> <paragraph num="(1)"> <text>A nonprofit facility subject to the jurisdiction of the Commission shall file with the Commission within 90 days from the close of its fiscal year a list of all trustees, directors, or officers of the facility.</text> </paragraph> <paragraph num="(2)"> <text>The list shall include the following:</text> <paragraph num="(a)"> <text>The name and business address of the trustee, director, or officer; and</text> </paragraph> <paragraph num="(b)"> <text>For each person so named, the nonprofit facility shall indicate whether the trustee, director, or officer is also an employee, partner, director, or beneficial owner of 3 percent or more of the capital account or stock of a partnership, firm, corporation, or any other business entity.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The information referred to in §I(2)(b), of this regulation, shall only be required if the business entity engaged in a transaction of $10,000 or more with the nonprofit facility during the previous fiscal year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Further Investigation by Commission."> <text>In order for the Commission to be able to assure the public that the costs of a hospital are reasonable and that the reports submitted by a hospital are accurate, the Commission may, at any time, conduct an investigation of a hospital's relevant records and accounts.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Notification of Certain Financial Transactions."> <paragraph num="A."> <text>General. A facility subject to the jurisdiction of the Commission shall notify the Commission, in writing, within 30 days before executing any financial transaction, contract, or other agreement that would:</text> <paragraph num="(1)"> <text>Pledge more than 50 percent of the operating assets of the facility as collateral for a loan or other obligation;</text> </paragraph> <paragraph num="(2)"> <text>Result in more than 50 percent of the operating assets of the facility being sold, leased, or transferred to another person or entity; or</text> </paragraph> <paragraph num="(3)"> <text>Result in more than 50 percent of all corporate voting rights or governance reserve powers being transferred to or assumed by another person or entity.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Information Required. A facility shall file with the Commission within 30 days before executing a proposed financial transaction, contract, or other agreement as required in §A of this regulation, the following information:</text> <paragraph num="(1)"> <text>The name and address of the person or entity to whom:</text> <paragraph num="(a)"> <text>The operating assets of the facility are being sold, leased, transferred, or pledged as collateral for a loan or other obligation; or</text> </paragraph> <paragraph num="(b)"> <text>The corporate voting rights or governance reserve powers are being transferred or assumed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The precise nature of the financial transaction, contract, or other agreement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Failure or Delay in Reporting Certain Financial Transactions.</text> <paragraph num="(1)"> <text>A facility under the jurisdiction of the Commission which does not notify the Commission of a proposed financial transaction, contract, or other agreement as required in §A of this regulation, is subject to all penalties prescribed by Commission law and regulation on failure to comply with reporting requirements.</text> </paragraph> <paragraph num="(2)"> <text>A required statement submitted to the Commission that is substantially incomplete or inaccurate is not considered timely filed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Publication of Notice by Commission. The Commission shall publish a notice of the proposed financial transaction, contract, or other agreement reported by a facility, in accordance with §A of this regulation, in a newspaper of general circulation in the area where the facility is located.</text> </paragraph> <paragraph num="E."> <text>Exception. The provisions of this regulation do not apply to any financial transaction, contract, or other agreement made by a facility with any issuer of tax-exempt bonds, including the Maryland Health and Higher Education Facilities Authority, the State, or any county or municipal corporation of the State, if a notice of the proposed issuance of revenue bonds that meets the requirements of §147(F) of the Internal Revenue Code has been published.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-207, 19-215, and 19-303,Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 24, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B, C, E, F, J, and K adopted effective September 19, 1974 (1:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 28, 1978 (5:15 Md. R. 1189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended effective May 4, 1979 (6:9 Md. R. 728)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 29, 1975 (2:24 Md. R. 1481); May 11, 1977 (4:10 Md. R. 767)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, E amended effective April 7, 1978 (5:7 Md. R. 522)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective August 18, 1976 (3:17 Md. R. 915); August 31, 1977 (4:18 Md. R. 1398); July 28, 1978 (5:15 Md. R. 1189); December 29, 1978 (5:26 Md. R. 1922); May 4, 1979 (6:9 Md. R. 728)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I adopted effective August 18, 1976 (3:17 Md. R. 915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective July 28, 1978 (5:15 Md. R. 1189); December 29, 1978 (5:26 Md. R. 1922); May 4, 1979 (6:9 Md. R. 728)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04 and .05 effective April 29, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended as an emergency provision effective December 23, 1976 (4:2 Md. R. 73)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective September 19, 1974 (1:1 Md. R. 17)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective April 7, 1978 (5:7 Md. R. 522)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 amended effective October 3, 1980 (7:20 Md. R. 1879)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 14, 1987 (14:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 14, 1987 (14:25 Md. R. 2660); May 29, 1989 (16:10 Md. R. 1109); April 5, 1999 (26:7 Md. R. 543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 8, 1990 (16:26 Md. R. 2793); February 4, 1991 (18:2 Md. R. 149); January 6, 1992 (18:26 Md. R. 2830); August 30, 1993 (20:17 Md. R. 1346); January 2, 1995 (21:26 Md. R. 2188); May 6, 1996 (23:7 Md. R. 553); April 7, 1997 (24:7 Md. R. 553); May 4, 1998 (25:9 Md. R. 680); April 5, 1999 (26:7 Md. R. 543); March 6, 2000 (27:4 Md. R. 454); July 9, 2001 (28:13 Md. R. 1216); September 30, 2002 (29:19 Md. R. 1524); March 29, 2004 (31:6 Md. R. 509); August 1, 2005 (32:15 Md. R. 1321); April 10, 2006 (33:7 Md. R. 673); June 4, 2007 (34:11 Md. R. 971); May 18, 2009 (36:10 Md. R. 717); April 5, 2010 (37:7 Md. R. 571); June 27, 2011 (38:13 Md. R. 756); July 9, 2012 (39:13 Md. R. 785); April 14, 2014 (41:7 Md. R. 422); December 21, 2015 (42:25 Md. R. 1543); August 13, 2018 (45:16 Md. R. 775); March 9, 2020 (47:5 Md. R. 311); February 8, 2021 (48:3 Md. R. 94); December 11, 2023 (50:24 Md. R. 1042); November 25, 2024 (51:23 Md. R. 1036); April 14, 2025 (52:7 Md. R. 323)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 1, 1985 (12:13 Md. R. 1279); December 10, 2001 (28:24 Md. R. 2128); October 5, 2009 (36:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 89); amended permanently effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 4, 2014 (41:15 Md. R. 890)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D, E amended effective November 30, 2009 (36:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F repealed effective January 1, 1983 (9:16 Md. R. 1605)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective January 1, 1984 (10:15 Md. R. 1351); October 10, 1994 (21:20 Md. R. 1732); February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, L amended effective August 3, 1981 (8:15 Md. R. 1308); November 19, 1984 (11:23 Md. R. 1992); July 1, 1985 (12:13 Md. R. 1279); March 10, 1986 (13:5 Md. R. 545)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, L amended as an emergency provision effective May 25, 1986 (13:12 Md. R. 1372); emergency status expired September 16, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H, L amended effective November 3, 1986 (13:22 Md. R. 2399); December 15, 1986 (13:25 Md. R. 2660); December 28, 1987 (14:26 Md. R. 2747); September 4, 1989 (16:17 Md. R. 1886); April 27, 1992 (19:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I repealed effective February 13, 2006 (33:3 Md. R. 241)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended as an emergency provision effective April 1, 2003 (30:8 Md. R. 538); amended permanently effective July 7, 2003 (30:13 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended effective June 6, 2005 (32:11 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L amended effective February 13, 2006 (33:3 Md. R. 241)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L-1, L-2 adopted effective March 8, 1999 (26:5 Md. R. 391)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L-1 amended effective November 15, 2010 (37:23 Md. R. 1610)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L-3 adopted effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03L-5 adopted effective January 13, 2011 (38:1 Md. R. 11)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03M amended effective November 11, 2024 (51:22 Md. R. 963)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03N amended as an emergency provision effective September 2, 1991 (18:19 Md. R. 2095); emergency status expired February 3, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulation .03N amended effective January 6, 1992 (18:26 Md. R. 2830); March 8, 1999 (26:5 Md. R. 391); March 4, 2013 (40:4 Md. R. 346)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective March 4, 2013 (40:4 Md. R. 346)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I adopted effective June 30, 1986 (13:13 Md. R. 1492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective January 6, 1992 (18:26 Md. R. 2830)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> </annotations> </chapter> <chapter num="02" heading="Standards of Rate Review"> <regulation prefix="Regulation" num=".01" heading="Vacant." /> <regulation prefix="Regulation" num=".02" heading="Review Standards for Rate Applications by Merged and Consolidated Hospitals."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Consolidation” means the extinguishment of two or more hospitals and by the same process a new hospital organization is formed, taking over the assets and assuming the liabilities of those passing out of existence.</text> </paragraph> <paragraph num="(2)"> <text>“Mergers” means the union of two or more hospitals by the transfer of all the property of one or more of them to one of them, which continues in existence, the others being merged therein. Only the hospital that continues in existence will receive Commission approved rates for acute hospital services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Specific Standard.</text> <paragraph num="(1)"> <text>In the event of a merger or consolidation as a result of which one or more of the participating hospitals no longer provides inpatient care at its existing location, the Commission shall approve rates for the surviving hospital or hospitals such that the revenues of the surviving hospital or hospitals are increased based upon one of two variable cost calculations, with the merged or consolidated facility choosing between the options.</text> </paragraph> <paragraph num="(2)"> <text>The first alternative is for the surviving hospital or hospitals to receive in relation to the new admission variable costs in the first year equal to 80 percent. This figure shall be reduced to 70 percent in the second year for those new admissions. For the third year and after that, the variable cost amount built into the hospital's base for these admissions shall be 60 percent. These variable cost percentages shall be limited to the number of admissions at the closed hospital. These amounts shall be applied to the average cost of hospitals in the screening group of the closed hospital (adjusted for wage differences as appropriate).</text> </paragraph> <paragraph num="(3)"> <text>The second alternative is for the surviving hospital to receive the normal 50 percent variable cost factor plus direct adjustments reflecting:</text> <paragraph num="(a)"> <text>The cost of debt transferred from the closed facility;</text> </paragraph> <paragraph num="(b)"> <text>A reasonable allowance for employees who are displaced by the merger or consolidation;</text> </paragraph> <paragraph num="(c)"> <text>A reasonable allowance for the retraining of employees;</text> </paragraph> <paragraph num="(d)"> <text>A reasonable allowance that permits the surviving institution to generate capital to convert a closed facility to an alternate health care use in conformance with the State Health Plan, which is incorporated by reference under COMAR 10.24.07; and</text> </paragraph> <paragraph num="(e)"> <text>A reasonable retention of a portion of the savings over a 3-year period.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A merged or consolidated hospital may request rates from the Commission at any time consistent with Commission law and regulation. A review of the hospital's request shall be undertaken in accordance with the review and approval procedures developed by the Commission in carrying out its responsibilities under Health-General Article, §19-217. Those procedures shall establish reasonable rates based upon the premise that hospitals are to provide effective and efficient service.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted effective May 15, 1986 (13:9 Md. R. 1030)</annotation> </annotations> </chapter> <chapter num="03" heading="Types and Classes of Charges Which Cannot Be Changed Without Prior Commission Approval"> <regulation prefix="Regulation" num=".01" heading="Changes in Rates."> <text>A hospital may not increase any existing rate or charge of any class or type or impose any new rate or charge of any class or type without the approval of the Commission, except for those changes specifically excepted by regulation or order of the Commission.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Changes in Unit Rates."> <paragraph num="A."> <text>A hospital may vary its unit rates within any 100 percent inpatient patient care center without prior Commission approval, if the variation does not change the average charge per unit of service as prescribed in the Commission's Rate Review System.</text> </paragraph> <paragraph num="B."> <text>A hospital may not vary its unit rates within any ancillary or ambulatory center without prior Commission approval if the Commission's Rate Review System prescribes a unit of service for that center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Rates for Auxiliary Enterprises in Other Institutional Program."> <text>Any hospital may change without prior approval of the Commission its unit rate or rates in any auxiliary enterprise or other institutional program as these centers are defined in the Commission's Uniform Accounting and Reporting System and the Commission's Rate Review System.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Rates for New Services."> <text>Any hospital may institute a rate for a new patient care service if the rate is less than $100 and does not change the average charge per unit of service for the patient care area in which the new patient care service is being provided.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Overcharges and Undercharges by Hospitals."> <paragraph num="A."> <text>For purposes of this regulation, the following definitions apply:</text> <paragraph num="(1)"> <text>“Overcharge” means any charge for a hospital service under the jurisdiction of the Commission that is in excess of its approved rate.</text> </paragraph> <paragraph num="(2)"> <text>“Undercharge” means any charge for a hospital service under the jurisdiction of the Commission that is less than its approved rate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When any hospital overcharges by more than the allowed corridors, as defined in §G of this regulation, that overcharge shall be recovered in prospective rates at 140 percent plus appropriate interest factors.</text> </paragraph> <paragraph num="C."> <text>When any hospital overcharges less than the allowed corridor, as defined in §G of this regulation, that overcharge shall be reduced from prospectively approved rates at the actual amount of overcharge plus appropriate interest.</text> </paragraph> <paragraph num="D."> <text>When any hospital undercharges more than 2 percent in obstetrics, nursery, labor and delivery, clinic, emergency room, pediatrics, or intensive care units, that undercharge may not be recovered in prospective periods.</text> </paragraph> <paragraph num="E."> <text>When any hospital undercharges less than 2 percent in the patient service centers listed in §D of this regulation, that undercharge shall be added to prospectively approved rates at the actual amount of undercharges.</text> </paragraph> <paragraph num="F."> <text>When a hospital undercharges beyond the allowed corridors, as defined in this section, the amount of undercharge in excess of the corridors less 40 percent shall be added to prospectively approved rates. These allowed undercharge corridors are defined as follows:</text> <paragraph num="(1)"> <text>Patient care areas, when the unit of service is</text> </paragraph> <paragraph num="(2)"> <text>Admissions center ---------------------------------- 3 percent;</text> </paragraph> <paragraph num="(3)"> <text>Ancillary service areas and ambulatory service</text> </paragraph> </paragraph> <paragraph num="G."> <text>Overcharge Corridors and Pricing for Medical/Surgical Supplies and Drugs.</text> <paragraph num="(1)"> <text>The allowed overcharge corridors are defined as follows:</text> <paragraph num="(a)"> <text>Daily patient care areas, ambulatory</text> </paragraph> <paragraph num="(b)"> <text>Labor and delivery room -------------------------- 3 percent;</text> </paragraph> <paragraph num="(c)"> <text>Renal dialysis ----------------------------------- 5 percent;</text> </paragraph> <paragraph num="(d)"> <text>Ancillary service areas other than labor and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>There are no price corridors for medical/surgical supplies and drugs.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Notwithstanding this regulation, if any hospital's net overcharges are more than 1 percent of the hospital's total approved revenue, that overcharge shall be recovered in prospective rates at 140 percent plus appropriate interest factors.</text> </paragraph> <paragraph num="I."> <text>In cases when a flagrant disregard of approved rates is found, the Commission may require direct repayment of overcharges and penalties to those patients who were overcharged.</text> </paragraph> <paragraph num="J."> <text>The Commission may assess penalties as described in this regulation, for rates approved effective July 1, 1978.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Change in Hospital-Based Physician Compensation Source."> <paragraph num="A."> <text>Each hospital shall promptly submit a rate application to the Commission for a change in rates whenever the source of a hospital-based physician's or physician support personnel's compensation has been modified (for example, a hospital-based physician previously compensated by the hospital commences billing fee for service or CRNA's previously compensated by the hospital are replaced by physicians billing fee for service.</text> </paragraph> <paragraph num="B."> <text>Any rate application submitted under the requirements of §A, of this regulation, shall relate only to those changes in rates resulting from a modification in the source of a hospital-based physician's or physician support personnel's compensation.</text> </paragraph> <paragraph num="C."> <text>Failure to submit a rate application as required under §A, of this regulation, shall subject the hospital to overcharge/undercharge penalties, as specified in Regulation .05, of this chapter, as if those funds presently provided for in rates and obtaining to the source of a hospital-based physician's compensation had not originally been approved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Change in Education Programs."> <paragraph num="A."> <text>Each hospital shall promptly submit a rate application to the Commission for a change in rates whenever an educational program conducted by the hospital has been modified (for example, the loss of a school of nursing program, the loss of resident/intern program, or a decrease in the number of students enrolled in the program).</text> </paragraph> <paragraph num="B."> <text>Any rate application submitted under the requirements of §A, of this regulation, shall relate only to those changes in rates resulting from a modification in an educational program conducted by a hospital.</text> </paragraph> <paragraph num="C."> <text>Failure to submit a rate application as required under §A, of this regulation, shall subject the hospital to the overcharge/undercharge penalties as specified in Regulation .05, of this chapter, as if those funds presently provided for in rates and obtaining to the hospital's educational program had not originally been approved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rates for Identified Physician Cost."> <paragraph num="A."> <text>Any hospital which incurs or accrues costs as a result of professional medical services which are personally rendered for an individual patient by a physician, and which contribute to the diagnosis or treatment of an individual patient, shall account for those costs as an Identified Physician Cost in accordance with the “Accounting and Reporting System for Hospitals” manual which is incorporated by reference in COMAR 10.37.01.02A(2).</text> </paragraph> <paragraph num="B."> <text>All those identified physician costs shall be charged to the individual patient as a separate charge and any bill rendered to a patient for those costs shall clearly and separately itemize those services and charges which are attributable to an identified physician cost.</text> </paragraph> <paragraph num="C."> <text>Any hospital may change without prior approval of the Commission its unit or rates for any identified physician cost as that center is defined in the Commission's “Accounting and Reporting System for Hospitals” and the Commission's “Rate Review System” which is incorporated by reference in COMAR 10.37.10.02B.</text> </paragraph> <paragraph num="D."> <text>The provisions of this regulation shall apply to all General Acute Care hospitals from October 1, 1983 and after that.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Rates for Non-Physician Services Provided to Hospital Inpatients by Third-Party Contractors."> <paragraph num="A."> <text>A non-physician inpatient service is defined as a hospital service under the jurisdiction of the Commission provided by a third-party contractor to a hospital inpatient off-site of the hospital. The charge for this service shall be billed by the hospital.</text> </paragraph> <paragraph num="B."> <text>The allowable rate shall be equal to or less than the Statewide median or price standard as developed by staff.</text> </paragraph> <paragraph num="C."> <text>The same rate on average shall be charged to all inpatients, regardless of payor.</text> </paragraph> <paragraph num="D."> <text>The sum of the rate charged to a hospital inpatient and the professional component, if any, on average, shall be not greater than that charged on average by the third-party contractor to its other patients for the sum of both components of the same service.</text> </paragraph> <paragraph num="E."> <text>The hospital shall provide an audit by an independent CPA that the contractor is in compliance with Sec. D of this regulation.</text> </paragraph> <paragraph num="F."> <text>The hospital shall be at risk for any payment made to a contractor in excess of the allowable charge determined in accordance with Sec. B of this regulation.</text> </paragraph> <paragraph num="G."> <text>The Commission shall waive COMAR 10.37.10.07A, which requires a rate application be filed at least 60 days before the opening of a new service, for rate applications approved under this regulation.</text> </paragraph> <paragraph num="H."> <text>The sections of this regulation are nonseverable and the entire regulation shall be null and void 60 days after a Court of competent jurisdiction rules that any portion or section of this regulation is beyond the jurisdiction of the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Rates for Services with Revenues Exempt from Commission Jurisdiction."> <paragraph num="A."> <text>Generally. The Commission may, on its own or upon application from a hospital, permit charges for services to be changed without its prior approval in those cases when 66-2/3 percent or more of the annual gross patient revenue attributable to the services is derived from either Medicaid or Medicare patients, or both, who are not required by State law or by the terms of the Medicare Waiver to pay Commission-approved rates for those services. The Commission shall consider this action only in those instances when the annual gross revenue for nonphysician services is not more than $20 million (in 1996 dollars), adjusted by an appropriate index of inflation, or when the annual gross revenue subject to Commission rate-setting jurisdiction is not more than $5 million (in 1996 dollars) adjusted by an appropriate index of inflation.</text> </paragraph> <paragraph num="B."> <text>Filing of Application. A hospital seeking a rate-setting exemption under this regulation shall file a written application with the Commission identifying the service or services for which the exemption is requested. The application shall contain accurate and supporting documentation that the conditions set forth in §A of this regulation have been met for a minimum period of 12 months immediately before the application. The filing of an application for a rate-setting exemption does not constitute a contested case within the meaning of that term as defined in the Administrative Procedure Act.</text> </paragraph> <paragraph num="C."> <text>Review of Application. The Commission staff shall review the application within a reasonable period of time and prepare a written recommendation on the request to the Commission. The decision to grant or deny the application rests within the sound discretion of the Commission.</text> </paragraph> <paragraph num="D."> <text>Required Reports. A hospital granted an exemption under this regulation is required to file quarterly reports, in a manner to be prescribed by the Commission, in order to verify that the conditions set forth in §A of this regulation still obtain. The hospital shall continue to file all other required reports in conformity with the Commission's Accounting and Budget Manual for Fiscal and Operating Management (the Manual), which is incorporated by reference under COMAR 10.37.01.02.</text> </paragraph> <paragraph num="E."> <text>Attestation. Responsible officials of an applicant hospital are required to attest that, to the best of their knowledge and belief, the reports filed, as required under §D of this regulation, have been prepared in conformity with the Commission's uniform accounting and financial reporting system as set forth in the Manual.</text> </paragraph> <paragraph num="F."> <text>Further Investigation. If the Commission considers a further investigation necessary or desirable to authenticate information reported by a hospital seeking a rate-setting exemption, the Commission may make any further examination of the records or accounts of the hospital in accordance with the rules or regulations of the Commission.</text> </paragraph> <paragraph num="G."> <text>Termination of Exemption. The Commission may terminate an exemption granted under this regulation at any time for cause.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§9-207, 19-210, 19-212, 19-215, 19-217, 19-219, and 19-220, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 14, 1975 (2:15 Md. R. 1066; 2:20 Md. R. 1298)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 18, 1976 (3:17 Md. R. 915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 6, 2008 (35:20 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective July 28, 1978 (5:15 Md. R. 1189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 31, 1992 (19:17 Md. R. 1607)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective April 15, 1991 (18:7 Md. R. 773)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended effective January 2, 1993 (19:26 Md. R. 2288)</annotation> <annotation type="History" subtype="Administrative History">Regulations .06 and .07 adopted effective August 3, 1981 (8:15 Md. R. 1308)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective November 19, 1984 (11:23 Md. R. 1992)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective April 12, 1982 (9:7 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 10, 1983 (10:20 Md. R. 1788)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted as an emergency provision effective April 1, 1984 (11:8 Md. R. 712); emergency status expired July 1, 1984; adopted permanently effective November 19, 1984 (11:23 Md. R. 1992)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 9, 1987 (14:3 Md. R. 274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective July 9, 1990 (17:13 Md. R. 1611); December 8, 2005 (32:24 Md. R. 1905)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective January 8, 1990 (16:26 Md. R. 2794); July 10, 2000 (27:13 Md. R. 1211); December 8, 2005 (32:24 Md. R. 1905)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective September 3, 1990 (17:17 Md. R. 2080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective October 6, 1997 (24:20 Md. R. 1404)</annotation> </annotations> </chapter> <chapter num="04" heading="Submission of Hospital Outpatient Data Set to the Commission"> <regulation prefix="Regulation" num=".01" heading="Collection and Submission of Data."> <paragraph num="A."> <text>Effective January 1, 2014, each hospital under the jurisdiction of the Health Services Cost Review Commission (Commission) shall submit the data elements as published in the Maryland Register and on the Commission's website (http://www.hscrc.maryland.gov) to the Commission within 15 days following the last day of the month during which the patient was discharged or died. The format for submission shall also be as published in the Maryland Register and on the Commission's website.</text> </paragraph> <paragraph num="B."> <text>A hospital under the jurisdiction of the Commission may apply to the Commission for an exception or an extension to the filing requirements of §A of this regulation as provided for in COMAR 10.37.01.02 and .03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Health Services Cost Review Commission (Commission)” means the independent organization within the Maryland Department of Health that is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, §19-201 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Hospital outpatient” means an encounter or visit to a hospital that does not result in an admission to the hospital.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Privacy of Information."> <text>Data submitted to the Commission in accordance with this chapter are not public information pursuant to Health-General Article, §19-207, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Summary Studies, Reports, Compilations."> <text>Summary studies, reports, or other compilations developed by the Commission or Commission staff from data submitted in accordance with this chapter shall be public information provided that, consistent with statutory law, disclosure is made in such a way that an individual patient or physician is not identified.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Corrections to Data."> <text>The Commission shall prescribe the process for hospitals to submit corrections and revisions to the data on its website.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-207, 19-212, 19-215, and 19-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 2, 1996 (23:24 Md. R. 1682)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .04 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); amended permanently effective October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 3, 2001 (28:17 Md. R. 1556)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 13, 2000 (27:22 Md. R. 2060; July 4, 2005 (32:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 13, 2000 (27:22 Md. R. 2060); September 3, 2001 (28:17 Md. R. 1556)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective July 4, 2005 (32:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 repealed effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 9, 2009 (36:5 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended as an emergency provision effective January 1, 2014 (40:24 Md. R. 2014); amended permanently effective March 3, 2014 (41:4 Md. R. 301)</annotation> </annotations> </chapter> <chapter num="05" heading="The Accounting and Budget Manual for Fiscal and Operating Management" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: July 7, 1976 (3:14 Md. R. 750)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted effective July 6, 1977 (4:14 Md. R. 1082)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 adopted effective July 15, 1979 (6:12 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 20, 1981 (8:14 Md. R. 1227)</annotation> </annotations> </chapter> <chapter num="06" heading="Submission of Hospital Discharge Data Set to the Commission"> <regulation prefix="Regulation" num=".01" heading="Collection and Submission of Data."> <paragraph num="A."> <text>Beginning on January 1, 2014, each hospital under the jurisdiction of the Health Services Cost Review Commission shall submit to the Commission:</text> <paragraph num="(1)"> <text>The data elements required by this chapter within 15 days after the last day of the month when the patient was discharged or died; and</text> </paragraph> <paragraph num="(2)"> <text>The reconciliation of inpatient data between the discharge data and the financial data filed with the Commission.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Submission Requirements.</text> <paragraph num="(1)"> <text>The data elements submitted under §A(1) o this regulation shall be made in the form as published in the Maryland Register and on the Commission’s website (http://hscrc.maryland.gov).</text> </paragraph> <paragraph num="(2)"> <text>The reconciliation submitted under §A(2) of this regulation shall be made in the manner, form, and time frame prescribed by Commission staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A hospital may apply to the Commission for an exception or an extension to its filing requirements as provided in COMAR 10.37.01.02 and .03.</text> </paragraph> <paragraph num="D."> <text>Failure to submit the required data and reconciliation information in a timely manner may subject the hospital to monetary penalties as provided in Commission law and regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Out-of-State Hospitals."> <paragraph num="A."> <text>The requirements for the collection and submission of data as described in Regulation .01 of this chapter shall also apply to those non-federal acute care hospitals located in Delaware, Pennsylvania, Virginia, West Virginia, and the District of Columbia. Data submitted by these non-Maryland hospitals shall relate exclusively to those patients who are Maryland residents.</text> </paragraph> <paragraph num="B."> <text>The Commission may consider these non-Maryland hospitals that otherwise provide discharge data as described in Regulation .04 of this chapter to the public to be exempt from the data requirements referred to in §A of this regulation. In addition, non-Maryland hospitals may apply to the Commission for an exception or an extension to either the form or to the manner of these data requirements as provided for in COMAR 10.37.01.02 and .03.</text> </paragraph> <paragraph num="C."> <text>If a non-Maryland hospital fails to submit discharge data on all Maryland patients as required by the Commission, the matter shall be referred by the Commission to Maryland's Medical Assistance Program for appropriate action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Uniform Hospital Discharge Abstract Data Set."> <text>Data Elements are as published in the Maryland Register and on the Commission's website (http://www.hscrc.state. md.us).</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Privacy of Information."> <text>Data submitted in accordance with this chapter are not public information pursuant to Health-General Article, §19-207(d), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Summary Studies, Reports, Compilations."> <text>Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information except that disclosure may not be made in a way that the data furnished by a specific patient can be identified.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Corrections to Data."> <text>The Commission shall prescribe the process for hospitals to submit corrections and revisions to the data on its website.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-207, 19-211, 19-212, 19-215, and 19-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1983 (9:16 Md. R. 1605)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02J, K repealed and new Regulation .02A, B(10) and (11) adopted effective July 1, 1985 (12:13 Md. R. 1280)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed effective January 1, 1986 (12:22 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted effective January 1, 1986 (12:22 Md. R. 2105)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective February 28, 2005 (32:4 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective February 7, 2000 (27:2 Md. R. 145)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective April 1, 1993 (20:5 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 1, 1986 (13:16 Md. R. 1827); November 3, 1986 (13:22 Md. R. 2400)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective November 17, 1986 (13:25 Md. R. 2653); emergency status expired March 1, 1987</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 9, 1987 (14:5 Md. R. 580); August 1, 1994 (21:15 Md. R. 1306); December 4, 1995 (22:24 Md. R. 1894); February 10, 1997 (24:3 Md. R. 187); August 5, 2002 (29:15 Md. R. 1142); July 4, 2005 (32:13 Md. R. 1112); June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective April 1, 1993 (20:5 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 1, 1994 (21:15 Md. R. 1306); December 4, 1995 (22:24 Md. R. 1894); February 10, 1997 (24:3 Md. R. 187)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, H amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended as an emergency provision effective November 17, 1986 (13:25 Md. R. 2653); emergency status expired March 1, 1987</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective March 9, 1987 (14:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective July 4, 2005 (32:13 Md. R. 1112); June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 1, 1993 (20:5 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 9, 2009 (36:5 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, B amended as an emergency provision effective January 1, 2014 (40:24 Md. R. 2014); amended permanently effective March 3, 2014 (41:4 Md. R. 301)</annotation> </annotations> </chapter> <chapter num="07" heading="Health Information Exchange Data"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of these regulations is to enable the Commission to fully measure and compare hospital-specific performance on readmissions and to use the data to further enhance and strengthen the financial incentives linked with performance.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Health Information Exchange (HIE)” means an infrastructure that provides organizational and technical capabilities for the exchange of protected health information electronically among entities not under common ownership.</text> </paragraph> <paragraph num="(2)"> <text>“Health Services Cost Review Commission (Commission)” means the independent organization within the Maryland Department of Health that is responsible for reviewing and approving the rates for hospitals pursuant to Health-General Article, §19-201 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Maryland Health Care Commission (MHCC)” means the agency established by Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Master Patient Index (MPI)” means an electronic database, created by the State-Designated HIE that maintains a unique index (or identifier) for every individual who has been, or who becomes, registered as a patient at a Maryland hospital.</text> </paragraph> <paragraph num="(5)"> <text>“State-Designated HIE” means an HIE designated by the MHCC.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Hospital Participation."> <text>Effective December 1, 2011, each hospital under the jurisdiction of the Commission shall electronically connect to the State-Designated HIE to enable the Commission to fully measure hospital-specific performance on readmissions using the HIE’s MPI.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Method of Connection."> <text>Each hospital shall establish connectivity with the State-Designated HIE over a secure and encrypted connection. This connectivity shall be established using industry standards specified by the State-Designated HIE.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Collection and Submission of Master Patient Index Data."> <text>Each hospital under the jurisdiction of the Commission shall collect and electronically submit to the State-Designated HIE the data elements as published in the Maryland Register and on the Commission’s website (http://www.hscrc.state.md.us). The format and data time period for submission shall also be published in the Maryland Register and on the Commission’s website.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Privacy of Information."> <text>Data submitted in accordance with this chapter are not public information pursuant to Health-General Article, §19-207(d), Annotated Code of Maryland. The Commission will take reasonable steps to safeguard and protect the confidentiality of protected health information consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Maryland Confidentiality of Medical Records Act, and all other applicable State and federal laws and regulations.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Studies, Reports, Compilations."> <text>Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information except that disclosure may not be made in such a way that the data furnished can lead to the identification of an individual.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Corrections to Data."> <text>The Commission shall prescribe on its website the process for a hospital to submit corrections and revisions to the data it has submitted.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Required Report."> <text>Data submitted in accordance with this chapter shall be considered a required report under COMAR 10.37.01.03N.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-143, 19-207, 19-212, 19-215, and 19-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 19, 2011 (38:18 Md. R. 1077)</annotation> </annotations> </chapter> <chapter num="08" heading="Conduct of Public Meetings"> <regulation prefix="Regulation" num=".01" heading="Frequency."> <text>Public meetings of the Commission may be held where and when the Commission directs for any authorized purpose, provided, however, that at least six meetings are held per year.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Attendance."> <text>A quorum need not be present in order for the Commission to hold a public meeting. If, however, less than a quorum is present at any public meeting, matters submitted for a vote shall be deferred.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Presiding Officer."> <text>The Chairman, or in his absence, the Vice-Chairman of the Commission or a designee shall preside at public meetings which may be called to order when the above presiding officer or his designee is in attendance. The Commission shall transact routine business and shall sit for the consideration of any and all matters which may properly be brought before it at the meeting.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Agenda."> <text>The Executive Director of the Commission in consultation with the Chairman shall be responsible for developing the agenda for each public meeting.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Records."> <text>Minutes of the meeting shall be taken by the Commission and made available for public inspection at the offices of the Commission, during ordinary business hours.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Voting."> <paragraph num="A."> <text>Each Commission member, except the Chairman, shall be entitled to one vote on each matter submitted to a vote at the meeting.</text> </paragraph> <paragraph num="B."> <text>Voting shall be in person or by proxy.</text> </paragraph> <paragraph num="C."> <text>The Chairman shall vote only to break a tie or cast a fourth concurring vote.</text> </paragraph> <paragraph num="D."> <text>During the time between public meetings, each Commission member shall be entitled to one vote on each matter submitted to vote.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Adjournment."> <text>A public meeting may be adjourned by a majority of those Commission members present in person.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 11, 1977 (4:10 Md. R. 767)</annotation> </annotations> </chapter> <chapter num="09" heading="Fee Assessment for Financing Hospital Uncompensated Care"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Automated clearing house (ACH)”, as defined in COMAR 03.01.02.01B, means a central clearing organization that operates as a clearing house for transmitting or receiving entries between banks and bank accounts, and authorizes an electronic transfer of funds between banks or bank accounts.</text> </paragraph> <paragraph num="(2)"> <text>“Commission” means the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="(3)"> <text>“Comptroller” means the Comptroller of the Treasury or the Comptroller's designee.</text> </paragraph> <paragraph num="(4)"> <text>“General Accounting Division” means the Fiscal Services Administration for the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Health Services Cost Review Commission Fund” means the special fund established under Health-General Article, §19-207.1(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Hospital” means an institution that is licensed by the Maryland Department of Health as an acute general hospital.</text> </paragraph> <paragraph num="(7)"> <text>“Hospital Uncompensated Care Fund” means the monies that are collected from hospitals for the equitable financing of hospital uncompensated care and which are a discrete part of the Health Services Cost Review Commission Fund.</text> </paragraph> <paragraph num="(8)"> <text>“Interest” means the investment earnings generated from the investment and reinvestment of the monies of the Hospital Uncompensated Care Fund which are separately held by the Treasury, accounted for by the Comptroller, and retained to the credit of the Health Services Cost Review Commission Fund.</text> </paragraph> <paragraph num="(9)"> <text>“Mark-up” means the mechanism used to increase hospital rates to allow for payer differentials, working capital (prompt payment) differentials, and a provision for uncompensated care.</text> </paragraph> <paragraph num="(10)"> <text>“Remittance” means the amount each hospital remits to the General Accounting Division pursuant to the predetermined formula established by the Commission to provide funding for the Commission's Hospital Uncompensated Care Fund.</text> </paragraph> <paragraph num="(11)"> <text>“Special rate adjustment” means an adjustment to a hospital's rates, which will bring the hospital's uncompensated care provision of its mark-up to the Statewide uncompensated care average.</text> </paragraph> <paragraph num="(12)"> <text>“Treasury” means the State Treasury.</text> </paragraph> <paragraph num="(13)"> <text>“Wire transfer” means an electronic transaction in which a hospital, through the hospital's bank and an automated clearing house, originates an entry crediting the Health Services Cost Review Commission Fund's bank account and debiting the hospital's bank account on the same day the transaction is initiated.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Special Rate Adjustment and Collection."> <paragraph num="A."> <text>The Commission shall make a special rate adjustment to the uncompensated care provision of each hospital's mark-up to pay for the financing of the reasonable costs of hospital uncompensated care. The Commission shall notify hospitals in writing of the amount due to be remitted in a given month before the first day of that month.</text> </paragraph> <paragraph num="B."> <text>On or before the first business day of each month, the Commission shall direct the General Accounting Division to arrange for the collection of the amount due to be remitted by individual hospitals. This amount shall be based on the difference between a hospital's uncompensated care provision in its mark-up and the Statewide uncompensated care average.</text> </paragraph> <paragraph num="C."> <text>The Commission shall, at the same time, notify the General Accounting Division in writing of the:</text> <paragraph num="(1)"> <text>Hospitals due to remit for that month;</text> </paragraph> <paragraph num="(2)"> <text>Amount of the remittance for that month;</text> </paragraph> <paragraph num="(3)"> <text>Hospitals to receive payments from the Hospital Uncompensated Care Fund for that month;</text> </paragraph> <paragraph num="(4)"> <text>Amount to be disbursed to hospitals from the Hospital Uncompensated Care Fund in that month; and</text> </paragraph> <paragraph num="(5)"> <text>The appropriate banking account information from each hospital in order to debit or disburse funds electronically by wire transfer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>All funds collected shall be transferred to the Hospital Uncompensated Care Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Payment of Remittance Due."> <paragraph num="A."> <text>By January 1, 2009, each hospital shall provide the Commission with sufficient banking information to facilitate the collection and disbursement of funds by the ACH or other wire transfer method. Each hospital shall initiate or authorize the ACH or other wire transfer method as directed by the Commission.</text> </paragraph> <paragraph num="B."> <text>On or before the 5th business day of each month, each hospital identified as due to remit monies in accordance with the provisions of these regulations shall make payment into the Hospital Uncompensated Care Fund in the manner prescribed by the Commission.</text> </paragraph> <paragraph num="C."> <text>On or before the 5th business day of each month, the Comptroller shall transfer monies out of the Hospital Uncompensated Care Fund and distribute monies to hospitals in the manner specified by the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Use of Funds."> <paragraph num="A."> <text>Funds generated through the special rate adjustment and the remittance due may only be used to finance the delivery of hospital uncompensated care.</text> </paragraph> <paragraph num="B."> <text>Interest earned from the monies collected shall be retained to the credit of the Hospital Uncompensated Care Fund.</text> </paragraph> <paragraph num="C."> <text>Interest earned may be used to pay for the reasonable expenses associated with implementation of the alternative methodology approved by the Commission for financing the reasonable costs of hospital uncompensated care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Repealed." /> <regulation prefix="Regulation" num=".06" heading="Failures or Delay in Paying Remittance/Penalties."> <paragraph num="A."> <text>The Commission may impose penalties of up to 5 percent of the amount of an underpayment, unless an extension is granted as provided in §E of this regulation.</text> </paragraph> <paragraph num="B."> <text>A hospital that violates the provisions of Regulation .03 of this chapter shall, in addition to the penalties imposed under §A of this regulation, be subject to an annualized interest charge of 3 percentage points above the most recent average prime rate of interest, as published in the “Money Rates” section of the The Wall Street Journal, on the unpaid balance.</text> </paragraph> <paragraph num="C."> <text>In addition to the penalties the Commission may impose on a hospital that fails to pay the remittance in a timely manner, the Commission may refer the hospital's delinquent account to the Department of Budget and Fiscal Planning's Central Collection Unit pursuant to the procedures in State Finance and Procurement Article, Title 3, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A hospital may file a written request with the Commission for a reasonable extension of time to make payment if the extension request is:</text> <paragraph num="(1)"> <text>Made in writing to the attention of the Executive Director;</text> </paragraph> <paragraph num="(2)"> <text>Supported by sufficient justification; and</text> </paragraph> <paragraph num="(3)"> <text>Made at a reasonable time before the due date of a required payment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request.</text> </paragraph> <paragraph num="F."> <text>Extensions will be granted only for valid reasons.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-207, 19-207.1, 19-207.3, and 19-214, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 10, 1997 (24:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 9, 1998 (25:5 Md. R. 369); May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation 01B amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation 02 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation 03 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective March 9, 1998 (25:5 Md. R. 369); May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation 04A, C amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 recodified to Regulation .06 and new Regulation .05 adopted effective March 9, 1998 (25:5 Md. R. 369)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation 05 repealed as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); repealed permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation 06 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423)</annotation> </annotations> </chapter> <chapter num="10" heading="Rate Application and Approval Procedures"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>“Burden of proof” means the burden of persuasion by the preponderance of the evidence.</text> </paragraph> <paragraph num="B."> <text>“Commission” means the Health Services Cost Review Commission.</text> </paragraph> <paragraph num="C."> <text>“Executive Director” means the Executive Director of the Commission, or in his absence, the Commission staff member designated to act in his stead.</text> </paragraph> <paragraph num="D."> <text>“Opinion” means a written statement setting forth the reasons and grounds why the writer of the statement believes that certain actions should be taken or decisions or recommendations made.</text> </paragraph> <paragraph num="E."> <text>“Order Nisi” means an order of the Commission that certain actions shall be taken or that certain matters are approved as of a future date, thereby permitting parties affected by the Order Nisi to make any objections they may have known to the Commission.</text> </paragraph> <paragraph num="F."> <text>Partial Rate Application.</text> <paragraph num="(1)"> <text>“Partial rate application” means a request by a hospital for the amendment or establishment of a single approved rate.</text> </paragraph> <paragraph num="(2)"> <text>“Partial rate application” includes, but is not limited to, those requests enumerated in Regulation .03B(4) of this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>“Publish” means the insertion of a public notice concerning proposed actions, including but not limited to public hearings, in a newspaper or newspapers in general circulation in the community in which the hospital affected is located, and, if the public notice relates to a public hearing, in the Maryland Register at least 15 days before the date of the public hearing.</text> </paragraph> <paragraph num="H."> <text>“Rate application” and “application” mean a hospital application for rate approval, to be submitted as specified in these regulations.</text> </paragraph> <paragraph num="I."> <text>“Recommendation” means a written statement from the Commission's staff to the Commission, advocating a resolution of issues or approval, disapproval, or modification of certain hospital rates and procedures for evaluating the rates.</text> </paragraph> <paragraph num="J."> <text>“Regression analysis” means a statistical technique used to measure and control for the effect of selected independent variables (for example, percentage of Medicaid revenue) on one dependent variable (for example, bad debts).</text> </paragraph> <paragraph num="K."> <text>“Uncompensated care” means care provided for which compensation is not received (that is, any combination of bad debts and charity care), and as more fully described in the Commission's Accounting and Budget Manual for Fiscal and Operating Management which is incorporated by reference at COMAR 10.37.01.02.</text> </paragraph> <paragraph num="L."> <text>“Value of the substantial, available, and affordable coverage (SAAC) differential” means the difference between the amount paid out by SAAC-approved nonprofit health service plans, health insurers, and health maintenance organizations on behalf of SAAC enrollees to hospitals, and what they would have paid to hospitals absent the differential.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Incorporation by Reference."> <text>The Alternative Rate Setting Method (ARM) Manual (1998) is hereby incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Rate Review System."> <paragraph num="A."> <text>The rate review system, otherwise known as the Accounting and Budget Manual for Fiscal and Operating Management, shall consist of:</text> <paragraph num="(1)"> <text>The rate review forms; and</text> </paragraph> <paragraph num="(2)"> <text>Instructions for completion of the forms.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The rate review system is incorporated by reference in COMAR 10.37.01.02.</text> </paragraph> <paragraph num="C."> <text>A hospital's rate review system and a schedule of published rates shall be filed by the last day of the third month after the close of the hospital's fiscal year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Regular Rate Applications."> <paragraph num="A."> <text>A hospital may not file a full rate application with the Commission until the Commission staff is able to determine through analysis that the data used to evaluate a full rate application has not been substantially affected by the COVID pandemic. During this interim period, a hospital may seek a rate adjustment under any other administrative remedy available to it under existing Commission law, regulation, or policy. In no event shall this moratorium continue in effect beyond June 30, 2023. Once the moratorium is lifted, a hospital may file a regular rate application at any time if:</text> <paragraph num="(1)"> <text>The rates being requested are not the subject of a hospital-instituted case pending before the Commission; or</text> </paragraph> <paragraph num="(2)"> <text>The subject hospital has not obtained permanent rates through the issuance of a Commission rate order within the previous 365 days.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Full Rate Application.</text> <paragraph num="(1)"> <text>“Full rate application” means a regular rate application which requests the amendment of more than one previously approved rate.</text> </paragraph> <paragraph num="(2)"> <text>In order for a full rate application to be docketed, it shall comply with a template for such applications as prescribed by the Commission staff and shall:</text> <paragraph num="(a)"> <text>Enumerate the services for which new rates are being requested, listing present and proposed rates;</text> </paragraph> <paragraph num="(b)"> <text>Be accompanied by appropriate supporting documents, including:</text> <paragraph num="(i)"> <text>The Annual Report of Revenues, Expenses, and Volumes projected and explained (e.g., how much of the requested increase relates to inflation, volumes, and other factors) for the period for which the hospital requests new rates;</text> </paragraph> <paragraph num="(ii)"> <text>Any audited financial statements over the most recent 5 years not yet filed with the Commission, plus the most recent unaudited financial statements for the current period, which are available at the time of the filing of the full rate application;</text> </paragraph> <paragraph num="(iii)"> <text>An Excel file listing and summarizing balance sheets, statements of operations and changes in net assets, and statements of cash flow for the last 5 years per the audited financial statements along with a narrative explaining any major changes;</text> </paragraph> <paragraph num="(iv)"> <text>An Excel file listing the information contained within the Annual Report RE schedules for the last 5 years breaking out regulated and unregulated revenues and expenses by category and in total;</text> </paragraph> <paragraph num="(v)"> <text>A detailed history of HSCRC-approved revenue and actual revenue for the hospital for the last 2 calendar years;</text> </paragraph> <paragraph num="(vi)"> <text>A detailed history for the most recent 4 Rate Years of HSCRC-approved GBR revenue and actual revenue and volumes, in addition to any approved and actual revenue and volumes available at the date of the filing of the full rate application. The history of approved and actual revenue changes should detail the basis of the changes in approved and actual revenue including allowed inflation and all other factors;</text> </paragraph> <paragraph num="(vii)"> <text>An identification of related organizations (i.e., an organization related to the hospital through some type of control or ownership), including subsidiaries of the hospital as well as hospitals that are part of the same hospital system as the applicant hospital. For applicant hospitals that are part of a system, the hospital may be required to submit financial and other information related to the system hospitals, including any system transactions among the system hospitals, which may affect the financial condition of the applicant hospital;</text> </paragraph> <paragraph num="(viii)"> <text>A listing of any services provided by related organizations including the amount charged to the applicant hospital for the services;</text> </paragraph> <paragraph num="(ix)"> <text>A listing of any transfers of funds to or from a related organization including an explanation of such transfers;</text> </paragraph> <paragraph num="(x)"> <text>Copies of the two most recent Medicare Cost Reports, including any home office cost report files — the Interns and Resident Information System report (IRIS) files, and the wage and occupational mix files, along with any adjustments and corrections;</text> </paragraph> <paragraph num="(xi)"> <text>Reconciliations of inpatient and outpatient volumes and revenue submitted in the HSCRC abstract data to the departmental revenue and statistics submitted monthly for the last 3 years;</text> </paragraph> <paragraph num="(xii)"> <text>In Excel, listing of Outpatient drugs accounting for at least 80 percent of the Hospital’s total outpatient drug expenses, with applicable HCPCS codes for last 3 years, including frequency of charges, amount of charges and units billed, Average Sales Price at the end of each year and applicable 340B discounts and an estimate of billed charges for unlisted drugs;</text> </paragraph> <paragraph num="(xiii)"> <text>For profits or losses associated with the support of physician practices, the applicant hospital may be required to provide a detailed accounting of those profits or losses over time. Additional information regarding compensation, subsidies and other forms of financial support provided to physicians may be required following staff’s initial review to the extent that these profits or losses have a material impact on the financial condition of the applicant hospital;</text> </paragraph> <paragraph num="(xiv)"> <text>A supporting document, in Excel, that compares the requested departmental rates of the applicant hospital to that hospital’s current departmental rates. The supporting document should also compare these current and requested departmental rates to those of other HSCRC-regulated hospitals located in the Primary Service Area (PSA) of the applicant hospital. If no other regulated hospitals are located in the applicant hospital’s PSA, then the comparison should be made to Statewide median departmental rates; and</text> </paragraph> <paragraph num="(xv)"> <text>An accounting of the amounts reported by the applicant hospital to the HSCRC regarding its uses of population health infrastructure money included in rates;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Include a description of the rate adjustments that are being requested in the full rate application;</text> </paragraph> <paragraph num="(d)"> <text>Include specific detail and substantiation of any circumstances the applicant hospital cites as unique to its facility, which would require revenue in excess of the amount currently provided in its approved regulated revenue;</text> </paragraph> <paragraph num="(e)"> <text>Describe in detail what the applicant hospital has specifically done consistent with the All-Payer Model to reduce or eliminate unnecessary or potentially avoidable utilization. For purposes of this regulation, unnecessary or potentially avoidable utilization means the utilization of health care items and services, including care furnished to treat complications during a hospital admission, that may be avoided through improved efficiency, care coordination, or effective community-based care, or that is not medically necessary or evidence-based care. The Staff may request additional information as needed;</text> </paragraph> <paragraph num="(f)"> <text>Provide estimates for the next 5 years of reductions in utilization that will be accomplished through care redesign initiatives;</text> </paragraph> <paragraph num="(g)"> <text>Provide a history of denials for the most recent 3 years, including any year-to-date figures; and</text> </paragraph> <paragraph num="(h)"> <text>Any additional information the Staff may request that bears directly on the hospital’s request for rate relief and its financial condition.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The provisions of §B(2) of this regulation may be waived by staff if the application applies only to:</text> <paragraph num="(a)"> <text>A request filed for a change in the applicant hospital’s uncompensated care allowance;</text> </paragraph> <paragraph num="(b)"> <text>A request for rates to cover government-mandated or similar action affecting more than one previously approved rate for which the staff believes the provisions of §B(2) of this regulation are not necessary; or</text> </paragraph> <paragraph num="(c)"> <text>A request for rates associated with a Certificate of Need-approved capital project, which request may be considered to be a “partial rate application” by staff.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Uncompensated Care Policy.</text> <paragraph num="(1)"> <text>The Commission's rate-setting methodology shall include in the rates of each hospital a provision for a reasonable level of uncompensated care provided at the hospital. The Commission may use a regression analysis or other statistical method to establish the reasonable level of uncompensated care.</text> </paragraph> <paragraph num="(2)"> <text>In establishing a reasonable level of uncompensated care in a full rate review, the Commission shall consider for each hospital the:</text> <paragraph num="(a)"> <text>Amount of uncompensated care actually incurred;</text> </paragraph> <paragraph num="(b)"> <text>Predicted amount of uncompensated care; and</text> </paragraph> <paragraph num="(c)"> <text>The hospital's requested amount.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A hospital may request a change in its approved provision of uncompensated care to the predicted amount by means of a partial rate application provided the request is revenue neutral.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Partial Rate Application."> <paragraph num="A."> <text>The provisions of Regulation .03B(2) of this chapter may be waived by staff in the review of a partial rate application.</text> </paragraph> <paragraph num="B."> <text>A hospital may file a partial rate application with the Commission at any time, consistent with the provisions of Regulation .03A of this chapter. A partial rate application is not a contested case under the provisions of the Administrative Procedure Act.</text> </paragraph> <paragraph num="C."> <text>The Commission shall act on a docketed partial rate application within the time frames established for a full rate application that does not involve a public hearing, consistent with Commission law and regulation.</text> </paragraph> <paragraph num="D."> <text>A hospital that has been denied its request for a partial rate change may file a full rate application with the Commission in accordance with Commission law and regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Commission Review of Established Rates."> <paragraph num="A."> <text>The Commission may order a review of a hospital's established rates at any time, as it deems necessary and proper.</text> </paragraph> <paragraph num="B."> <text>This order, provided it orders the review of any rate or charge, may constitute a Commission-initiated rate proceeding.</text> </paragraph> <paragraph num="C."> <text>In reviewing a hospital’s established rates during a Commission-initiated rate proceeding or while reviewing a hospital’s full rate application, the Commission shall consider the hospital’s performance since the implementation of the All-Payer Model Agreement with the federal government, which took place in February 2014.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Rate Efficiency Methodology."> <paragraph num="A."> <text>In evaluating the reasonableness of a hospital's permanent rate structure, the Commission shall use an Inter-hospital Cost Comparison (ICC) methodology, which compares the costs of the hospital to those costs, including adjustments for reasonableness and efficiency, of its peer hospitals, with appropriate adjustments to reflect changes in the hospital’s volume since the beginning of the new All-Payer Model Agreement and the inception of the hospital’s revenue agreement, as the foundation of its review of the full rate application. The staff shall make modifications to the ICC which are needed to properly reflect any additional factors that are relevant to the determination of a reasonable cost level that should be reflected in the hospital’s approved regulated revenue. The ICC analysis does not constitute a strict, unalterable or absolute methodology. It shall be modified as needed to give proper attention to the particular circumstances of the hospital, and the staff shall give due consideration to information provided by the hospital in determining the appropriate rate levels and rate structure for the hospital. The ICC shall take into account, in the establishment of appropriate rate levels, those factors for which the hospital will not be held accountable such as special grants from the Commission, assessments, uncompensated care levels, and characteristics of the population in the hospital’s primary service area.</text> </paragraph> <paragraph num="B."> <text>Factors considered in the ICC methodology may evolve during the course of full rate reviews. The Commission shall take into account the specific circumstances of the applicant hospital, and staff shall make the key contents, analytic steps, and findings of such reviews available to all hospitals and the public.</text> </paragraph> <paragraph num="C."> <text>When reviewing a full rate application filed by a hospital that is owned or controlled by a hospital system that also owns other hospitals located in Maryland, the Commission may take into account the financial situation of the other hospitals in the system including their profitability and any shifts of services, volume, revenues or assets between the hospital and the other hospitals or related organizations of the system.</text> </paragraph> <paragraph num="D."> <text>The final rates that are approved by the Commission for a nonprofit hospital’s permanent rate structure shall allow the hospital to charge reasonable rates that will permit it to provide, on a solvent basis, effective and efficient service that is in the public interest.</text> </paragraph> <paragraph num="E."> <text>The final rates that are approved by the Commission for a proprietary profit-making hospital’s permanent rate structure shall allow the hospital to charge reasonable rates that will permit it to provide effective and efficient service that is in the public interest and include enough allowance for and provide a fair return to the owner of the hospital.</text> </paragraph> <paragraph num="F."> <text>The Commission shall set rates for the applicant hospital consistent with the All-Payer Model approved by the federal Center for Medicare and Medicaid Innovation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-2" heading="Global Budget Revenue Methodology."> <paragraph num="A."> <text>The Global Budget Revenue (GBR) methodology implemented by the Commission effective January 1, 2014, establishes reasonable revenue levels for Maryland's general acute hospitals, which will enable them to improve quality and efficiency on a solvent basis within the constraints imposed by the All-Payer Model.</text> </paragraph> <paragraph num="B."> <text>In setting reasonable revenue levels, the Commission shall take into account a number of factors. These may include, but are not limited to the following:</text> <paragraph num="(1)"> <text>The casemix severity and reasonable utilization of the hospital’s patients;</text> </paragraph> <paragraph num="(2)"> <text>The historical charges of the hospital;</text> </paragraph> <paragraph num="(3)"> <text>The statutory requirement regarding the reasonable relationship between costs and charges;</text> </paragraph> <paragraph num="(4)"> <text>The hospital’s payer mix;</text> </paragraph> <paragraph num="(5)"> <text>The reasonable uncompensated care requirements of the hospital;</text> </paragraph> <paragraph num="(6)"> <text>The reasonable Graduate Medical Education (GME) costs of the hospital as determined by the Commission;</text> </paragraph> <paragraph num="(7)"> <text>Appropriate adjustments, if any, associated with exceptional or outlier cases as defined by the Commission;</text> </paragraph> <paragraph num="(8)"> <text>Wage levels at the hospital and at other hospitals in the geographic area of the hospital and elsewhere in Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Adjustments for quality improvement and value-based payment programs applicable to the hospital;</text> </paragraph> <paragraph num="(10)"> <text>Reasonable infrastructure funding for care management and care coordination for hospital patients;</text> </paragraph> <paragraph num="(11)"> <text>The annual update factor;</text> </paragraph> <paragraph num="(12)"> <text>The proportion of unnecessary care, including Potentially Avoidable Utilization (PAU) at the hospital; and</text> </paragraph> <paragraph num="(13)"> <text>The performance of the State as a whole under the All-Payer Model.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The GBR shall be implemented through a written agreement entered into by the Commission and each individual general acute hospital. This agreement and any addenda thereto, which shall be annual and renewed automatically, shall set forth all relevant provisions governing the GBR including, but not limited to, performance corridors; interim rate adjustments; the exclusion or special treatment of certain cases; the treatment of volume changes, including those involving residents of Maryland and other patients; the penalties associated with failure to comply with the terms of the GBR agreement; interim revenue limits; care redesign requirements; and other changes to the agreement that may be needed from time to time. A hospital that enters into a GBR agreement shall submit a signed copy of the agreement to the Commission’s offices within 60 days after it is initially approved by the Commission. A hospital that is party to the addendum shall submit a signed copy of the addendum to the Commission’s offices within 60 days from the issuance of the addendum. Failure to submit the signed GBR agreement or the signed addendum in a timely manner, absent an extension granted by staff, may subject the hospital to penalties under COMAR 10.37.01.03R. Thereafter, on an annual basis, the hospital shall receive an updated rate order. A hospital that disagrees with a proposed GBR may file a full rate application with the Commission in accordance with Regulation .03 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-3" heading="Global Budget Revenue Mechanism."> <paragraph num="A."> <text>For purposes of this regulation, the following definitions apply:</text> <paragraph num="(1)"> <text>“Annual update factor” means the amount by which total State hospital revenue may increase in a rate year.</text> </paragraph> <paragraph num="(2)"> <text>“Demographic adjustment” means the percentage increase in allowed revenue related to changes in population and the age/sex mix of the population residing in the hospital’s primary service area, net of any reductions.</text> </paragraph> <paragraph num="(3)"> <text>“Factor cost inflation” means increases in the costs of goods, services, wages, and salaries experienced by the hospitals as calculated by the Commission for the most recent period for which data are available preceding the year for which the Commission calculates case target updates.</text> </paragraph> <paragraph num="(4)"> <text>“Hospital update” means the amount by which an individual hospital’s approved GBR revenue changes in a particular rate year (i.e., July 1—June 30).</text> </paragraph> <paragraph num="(5)"> <text>“Market shift adjustment” means the rate adjustment applied by the Commission, which increases or decreases the approved GBR revenue of a hospital to reflect changes in volume at the hospital for which there was a corresponding change in volume at another Maryland hospital or other provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Annual Update Factor.</text> <paragraph num="(1)"> <text>On or before July 1 of each year, the Commission shall establish an annual update factor for the purpose of adjusting the GBR revenue of each individual hospital. The annual update factor shall be designed to reflect projected factor cost inflation, an allowance for certain volume adjustments, productivity adjustments, the revenue constraints included in the All-Payer Model Agreement and other relevant factors, demographic adjustments, market shift adjustments, and other appropriate adjustments.</text> </paragraph> <paragraph num="(2)"> <text>If after approving an update factor for a given year, a hospital or hospitals collectively exceed their approved revenue, the annual update factor may be reduced in future years to recoup the excess revenue growth. Similarly, if a Maryland hospital or hospitals collectively fall below their approved revenue for a given year, the annual update factor may be adjusted accordingly in future years.</text> </paragraph> <paragraph num="(3)"> <text>If Maryland hospitals accrue a national growth reduction for 2 consecutive years, in the following year the annual update factor shall be reduced by the first of the 2-year national growth reduction. Except as provided in §D of this regulation, the annual update may not be less than 1 percent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The technical provisions of the methodology used to convert the annual update factor into the hospital update for the next rate year shall be fully described and publicly disseminated on or before July 1 of each year, allowing sufficient time for comment and implementation.</text> </paragraph> <paragraph num="D."> <text>Corrective Action. If, at any time, the Commission estimates that the financial constraints or other terms imposed by the All-Payer Model Agreement are at risk of being violated (based on modelling using the CMS actuary’s most recent projections and Health Services Cost Review Commission analysis of Medicare payments data), the Commission may take immediate and appropriate corrective action as it deems necessary and proper to meet the Medicare savings requirements and limits on growth in Medicare payments and prevent any further deterioration in compliance with the Model Agreement. The Commission shall provide sufficient notice and opportunity for comment before taking corrective action. This comment opportunity does not constitute a contested case within the meaning of the Administrative Procedure Act.</text> </paragraph> <paragraph num="E."> <text>The provisions of this regulation apply to all Maryland's general acute care hospitals from July 1, 2014, and thereafter.</text> </paragraph> <paragraph num="F."> <text>Compliance and Penalties. GBR compliance shall be monitored during the agreement period. Penalties shall be assessed prospectively at the beginning of the next period. Penalties shall be based on the corridors specified in the GBR Agreement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application for Temporary Change in Rates."> <paragraph num="A."> <text>The Commission may issue a general notice setting forth circumstances under which a hospital may obtain a temporary change in rates. The rates, if approved or modified, shall be effective before the rate review procedure set forth in these regulations, but not before the date of application.</text> </paragraph> <paragraph num="B."> <text>A hospital may apply at any time for a temporary change in rates provided that one of the following conditions is satisfied:</text> <paragraph num="(1)"> <text>A decline in the hospital's experienced or projected net revenues, due to factors beyond the hospital's control, requiring funds beyond those normally available;</text> </paragraph> <paragraph num="(2)"> <text>An increase in the hospital's experienced or projected expenses, due to factors beyond the hospital's control, requiring funds beyond those normally available; or</text> </paragraph> <paragraph num="(3)"> <text>A hospital's expenses from regulated services exceed its revenues from regulated services, or the hospital's financial integrity is otherwise jeopardized (for example, for breaching its bond covenants).</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission and its staff shall review the application and consult with the hospital as to the necessity for the temporary change in rates and the amount of the change required. Designated interested parties shall have 6 working days from the filing of the application to submit comments to the Commission.</text> </paragraph> <paragraph num="D."> <text>Within 12 working days from the filing of the application, the Commission shall issue its order:</text> <paragraph num="(1)"> <text>Denying the temporary change in rates and stating the grounds therefor; or</text> </paragraph> <paragraph num="(2)"> <text>Granting a temporary change in rates, stating:</text> <paragraph num="(a)"> <text>The amount of the temporarily changed rates, which may or may not be the same as the rates set forth in the hospital's application;</text> </paragraph> <paragraph num="(b)"> <text>The necessity for the temporary change in rates;</text> </paragraph> <paragraph num="(c)"> <text>That a regular rate review proceeding on the proposed rates will be conducted by the Commission as soon as practicable;</text> </paragraph> <paragraph num="(d)"> <text>The availability of copies of the order at the offices of the Commissioner; and</text> </paragraph> <paragraph num="(e)"> <text>The availability of the record of the temporary rate application for inspection at the Commission's office during ordinary business hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Commission order denying or granting the temporary change in rates shall be published and copies forwarded to:</text> <paragraph num="(1)"> <text>The hospital;</text> </paragraph> <paragraph num="(2)"> <text>Designated interested parties; and</text> </paragraph> <paragraph num="(3)"> <text>Persons writing to the Commission requesting a copy of the order.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In conducting an expedited review to establish a temporary rate for both inpatient and outpatient services, the Commission shall consider the hospital’s financial condition in addition to its relative efficiency and effectiveness in its performance under the Total Cost of Care Model. A temporary rate approved by the Commission may not result in regulated revenue exceeding regulated expenses in the most recently completed fiscal year.</text> </paragraph> <paragraph num="G."> <text>A temporary change in rates is subject to the Commission's final rate order in the regular rate review proceeding, which may be effective as of the date of the temporary rate order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Alternative Method of Rate Determination."> <paragraph num="A."> <text>At any time on or after July 1, 1974, a hospital may file a written application with the Commission requesting an alternative method for submitting or reviewing any or all of its rates and charges, specifying the reasons for and details of the alternative methods.</text> </paragraph> <paragraph num="B."> <text>If warranted by the circumstances set forth in the application, the Executive Director may grant a temporary approval of an alternative method of rate determination.</text> </paragraph> <paragraph num="C."> <text>The procedure for submitting and reviewing an application under an alternative method of rate determination shall follow as closely as possible the procedure for a regular rate application, except that the time periods and limitations set forth in these regulations do not apply to an application for an alternative method of rate determination.</text> </paragraph> <paragraph num="D."> <text>At anytime after the approval of an alternative method of rate review by the Executive Director, the Commission may initiate further proceedings to determine the hospital's continuing qualification for the alternative method of rate determination.</text> </paragraph> <paragraph num="E."> <text>ARM System.</text> <paragraph num="(1)"> <text>The Commission may implement a system providing for alternative rate setting methods (ARM) which would permit hospitals to accept financial risk for the provision of hospital services under certain conditions and circumstances.</text> </paragraph> <paragraph num="(2)"> <text>The implementation of an ARM system shall be consistent with the principles of equity and access embodied in the Commission's all-payer rate setting system.</text> </paragraph> <paragraph num="(3)"> <text>The ARM Manual shall set forth the process and requirements associated with the ARM system.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Required Reports under ARM System.</text> <paragraph num="(1)"> <text>A hospital granted approval for an alternative method of charging under this regulation is required to file quarterly reports and annual reports, to include but not be limited to those listed below in this section, in order to determine that the hospital continues to qualify for the alternative method of rate determination.</text> </paragraph> <paragraph num="(2)"> <text>Quarterly Reports. The following reports shall be completed in the form prescribed by the Commission and submitted to the Commission within 30 days after the end of each hospital's calendar quarter:</text> <paragraph num="(a)"> <text>Statistical Data Summary—Each Capitation or Risk-Sharing Contract;</text> </paragraph> <paragraph num="(b)"> <text>Statistical Data Summary—Each Fixed-Price Contract;</text> </paragraph> <paragraph num="(c)"> <text>Statistical Data Summary—Other;</text> </paragraph> <paragraph num="(d)"> <text>Revenue Summary—Each Capitation or Risk-Sharing Contract;</text> </paragraph> <paragraph num="(e)"> <text>Revenue Summary—Each Fixed-Price Contract; and</text> </paragraph> <paragraph num="(f)"> <text>Revenue Summary—Other.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Annual Reports. The following annual reports shall be completed in the form prescribed by the Commission and submitted to the Commission within 90 days after the end of the appropriate fiscal year:</text> <paragraph num="(a)"> <text>Statement of Revenue and Expense—Each Capitation or Risk-Sharing Contract;</text> </paragraph> <paragraph num="(b)"> <text>Statement of Revenue and Expense—Each Fixed-Price Contract;</text> </paragraph> <paragraph num="(c)"> <text>Statement of Revenue and Expense—Other;</text> </paragraph> <paragraph num="(d)"> <text>Audited Statement of Revenue and Expense—Contracting Entity; and</text> </paragraph> <paragraph num="(e)"> <text>Audited Balance Sheet—Contracting Entity.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Filing of Reports/Extension.</text> <paragraph num="(a)"> <text>A hospital required to file the reports in this section may request a reasonable extension of time for filing, if the extension request is:</text> <paragraph num="(i)"> <text>Made in writing to the attention of the Executive Director;</text> </paragraph> <paragraph num="(ii)"> <text>Supported by sufficient justification; and</text> </paragraph> <paragraph num="(iii)"> <text>Made at a reasonable time before the due date of a required report.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request.</text> </paragraph> <paragraph num="(c)"> <text>Extensions will be granted only for valid reasons.</text> </paragraph> <paragraph num="(d)"> <text>Any required report submitted by a hospital that is substantially incomplete or inaccurate shall be considered untimely filed.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Time for Filing. An application for an alternative rate application shall be filed at least 30 days before the proposed effective date of the alternative rate.</text> </paragraph> <paragraph num="(6)"> <text>Penalties.</text> <paragraph num="(a)"> <text>The Commission may impose penalties of up to $1,000 per day for failing to file reports as required under this section.</text> </paragraph> <paragraph num="(b)"> <text>The Commission may refuse to grant a rate increase to a hospital that does not file a report as required under this section.</text> </paragraph> <paragraph num="(c)"> <text>A fine assessed for failure to file an alternative rate application on a timely basis shall begin as of the date the application should have been filed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Funding for Health Information Technology.</text> <paragraph num="(1)"> <text>The Commission may adjust a hospital's rates for health information technology (HIT) projects in conjunction with action taken by the Maryland Health Care Commission (MHCC) under COMAR 10.25.13.</text> </paragraph> <paragraph num="(2)"> <text>Upon receipt of a recommendation for funding from the MHCC, the Commission's staff shall:</text> <paragraph num="(a)"> <text>Review the information presented;</text> </paragraph> <paragraph num="(b)"> <text>Consult with appropriate parties; and</text> </paragraph> <paragraph num="(c)"> <text>Recommend to the Commission approval, denial, or modification of the MHCC recommendation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In deciding the course of action to follow on an MHCC HIT project recommendation, the Commission and its staff shall consider, among other things, the following criteria:</text> <paragraph num="(a)"> <text>The basis for the MHCC recommendation;</text> </paragraph> <paragraph num="(b)"> <text>The applicant's statement of the purpose, mission, vision, goals, and measurable objectives of the project;</text> </paragraph> <paragraph num="(c)"> <text>The planned approach, including:</text> <paragraph num="(i)"> <text>An explanation of how the project's goals and objectives will be met;</text> </paragraph> <paragraph num="(ii)"> <text>The technical strategy of the project;</text> </paragraph> <paragraph num="(iii)"> <text>What activities will be used;</text> </paragraph> <paragraph num="(iv)"> <text>What personnel will be needed; and</text> </paragraph> <paragraph num="(v)"> <text>How that personnel will be utilized;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>How the project will be evaluated, as well as specific measurement strategies;</text> </paragraph> <paragraph num="(e)"> <text>A timeline that includes the start and end dates of the project and a schedule of activities;</text> </paragraph> <paragraph num="(f)"> <text>The credentials of the entity and participating individuals, including information that demonstrates their background and ability to carry out the project successfully;</text> </paragraph> <paragraph num="(g)"> <text>The potential of the project to enhance the value of health care in Maryland, such as improving health care outcomes and reducing health care costs;</text> </paragraph> <paragraph num="(h)"> <text>Information that demonstrates why the project is needed; and</text> </paragraph> <paragraph num="(i)"> <text>A budget that details cost projections for the project that is specific, reasonable, realistic, accurate, and flexible.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Decision.</text> <paragraph num="(a)"> <text>Based on its consideration of the above-stated criteria and staff's recommendation, the Commission shall decide on the nature, extent, terms, and conditions of any rate adjustment approved.</text> </paragraph> <paragraph num="(b)"> <text>The decision of the Commission on an MHCC recommendation for HIT funding is final.</text> </paragraph> <paragraph num="(c)"> <text>A request for funding under this section is not a contested case under the Administrative Procedure Act.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rate Applications by New Hospitals or Existing Hospitals with Expanded Facilities or New Revenue Centers."> <paragraph num="A."> <text>At least 60 days before the operational opening of a new hospital, a revenue center, or a new service within a hospital whose projected annual operating cost exceeds $100,000, the hospital shall file a rate application for the requested rates. This application shall be supported by financial data presented in the format of the Commission's rate review system.</text> </paragraph> <paragraph num="B."> <text>If an existing hospital expends its operations so that the number of in-patient beds is increased by 20 percent or more, and if a rate application is filed pertaining to the expended facilities and providing for an occupancy rate for the expanded facilities of the hospital at an amount below the target occupancy established by the Commission, the Commission may require the filing of additional information projecting the hospital's expanded facilities' activity levels for the first 5 years of their operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07-1" heading="Outpatient Services — At the Hospital Determination."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“At the hospital” means a service provided in a building on the campus of a hospital in which hospital services are provided.</text> </paragraph> <paragraph num="(b)"> <text>“Health care provider” means an individual who is licensed, certified, or otherwise authorized by law to provide health care services under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(c)"> <text>“Telehealth services” means the delivery of health care services provided through the use of interactive audio, video, or other telecommunications or electronic technology by a health care provider at a hospital to a patient at a location other than at the hospital, or to a patient at the hospital where the provider is at a location other than the hospital, which enables the patient to interact with the health care provider at the time the health care services are provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A service at the hospital is:</text> <paragraph num="(1)"> <text>Presumed to be an outpatient service; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to rate regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to outpatient services provided at the hospital. Outpatient services associated with the federal 340B Program under the federal Public Health Service Act provided in a department of a regulated hospital that, on or before June 1, 2015, is under a merged asset hospital system, and which are physically located at another regulated hospital under the same merged asset hospital system, shall be subject to the rate-setting jurisdiction of the Commission. The Commission may begin setting rates for these services in anticipation of the hospital’s obtaining provider-based status for purposes of the 340B Program.</text> </paragraph> <paragraph num="D."> <text>A hospital that desires an exception to the presumption stated under §C of this regulation must receive a determination under the provisions of this regulation.</text> </paragraph> <paragraph num="E."> <text>Commission Approval.</text> <paragraph num="(1)"> <text>A hospital may not charge a Commission-approved rate for an outpatient service without prior Commission or Commission staff approval.</text> </paragraph> <paragraph num="(2)"> <text>A hospital may not open a new outpatient service, relocate an existing outpatient service, or convert an existing outpatient service from regulated or unregulated status without a prior determination from the Commission’s staff as to whether the service is being provided at the hospital. A request for determination shall be made in writing at least 60 days before the contemplated action.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Upon request for an exception under §D of this regulation, the Commission's staff shall:</text> <paragraph num="(1)"> <text>Review the information presented;</text> </paragraph> <paragraph num="(2)"> <text>Consult with appropriate parties;</text> </paragraph> <paragraph num="(3)"> <text>Visit the site of the service as it considers necessary; and</text> </paragraph> <paragraph num="(4)"> <text>Notify the hospital of its determination as soon as practicable.</text> </paragraph> </paragraph> <paragraph num="G."> <text>In deciding whether an outpatient service is at the hospital, the Commission staff may consider, among other things, the following criteria:</text> <paragraph num="(1)"> <text>Location of the entrances;</text> </paragraph> <paragraph num="(2)"> <text>Location and signage of parking;</text> </paragraph> <paragraph num="(3)"> <text>Location and language of signage at entrances, within buildings, on the campus, and in parking areas effectively alerting the public that a given building or service is either at the hospital or not at the hospital;</text> </paragraph> <paragraph num="(4)"> <text>Location of registration, changing, and waiting areas;</text> </paragraph> <paragraph num="(5)"> <text>Whether billing reflects clearly that the service is rate regulated or not rate regulated;</text> </paragraph> <paragraph num="(6)"> <text>Whether any physical connection from an unregulated facility to the hospital, such as tunnels, hallways, covered walkways, elevators, or connecting bridges, will be restricted to hospital staff and physician use in order to ensure that patients and visitors do not have access to the unregulated facility from the hospital;</text> </paragraph> <paragraph num="(7)"> <text>Whether there is any duplication of an unregulated service within the hospital in order to avoid inappropriate patient steering;</text> </paragraph> <paragraph num="(8)"> <text>Whether there is any inappropriate mixing of regulated and unregulated services in the same building, which would tend to have the effect of confusing patients about the regulated or nonregulated status of a given service being provided; and</text> </paragraph> <paragraph num="(9)"> <text>Whether any Medicare Part B physician's service being provided in an unregulated building also includes components of a Medicare Part A hospital service that would be reasonably expected by a patient to fall under Commission rate-setting jurisdiction.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Based on consideration of the criteria stated in §G of this regulation, the Commission's staff shall make its determination on the request made under §E of this regulation.</text> </paragraph> <paragraph num="I."> <text>A hospital that fails to obtain or violates a staff determination on the hospital status of a given service may be subject to fines for inaccurate reporting under COMAR 10.37.01.03R and paybacks for inappropriate charges made during the time a staff determination on an outpatient service was not obtained or adhered to.</text> </paragraph> <paragraph num="J."> <text>A request for a determination under this regulation is not a contested case under the Administrative Procedure Act.</text> </paragraph> <paragraph num="K."> <text>A hospital may not bill a separate hospital facility fee when a health care provider who provided telehealth services is authorized to bill independently for the professional services rendered.</text> </paragraph> <paragraph num="L."> <text>The delivery of telehealth services as described in §A(2) of this regulation constitutes outpatient services provided at the hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07-2" heading="Outpatient Services — Freestanding Medical Facility."> <paragraph num="A."> <text>Definition. In this regulation, “freestanding medical facility” means a freestanding medical facility licensed under Health-General Article, Title 19, Subtitle 3A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The following outpatient services provided at a freestanding medical facility are considered hospital services under Health-General Article, §19-201, Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Emergency Services;</text> </paragraph> <paragraph num="(2)"> <text>Observation Services; and</text> </paragraph> <paragraph num="(3)"> <text>Associated Ancillary Services, such as laboratory, radiology, imaging, EKG, and Medical/Surgical Supplies and Drugs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to those outpatient services provided at a freestanding medical facility, as designated by the Commission.</text> </paragraph> <paragraph num="D."> <text>A freestanding medical facility or a proposed freestanding medical facility that desires to provide a service not designated in §B of this regulation (an undesignated service) must receive a determination under the provisions of this regulation.</text> </paragraph> <paragraph num="E."> <text>Commission Approval.</text> <paragraph num="(1)"> <text>A freestanding medical facility may not charge a Commission-approved rate for an undesignated service without prior Commission staff approval.</text> </paragraph> <paragraph num="(2)"> <text>A freestanding medical facility may not open a new outpatient service, relocate an existing outpatient service, or convert an existing outpatient service from regulated or unregulated status without a prior determination from the Commission’s staff as to whether the service constitutes a hospital service subject to Commission rate regulation. A request for determination shall be made in writing at least 60 days before the contemplated action.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Upon request for a determination, the Commission’s staff shall:</text> <paragraph num="(1)"> <text>Review the information presented;</text> </paragraph> <paragraph num="(2)"> <text>Consult with appropriate parties;</text> </paragraph> <paragraph num="(3)"> <text>Visit the site of the service as it considers necessary; and</text> </paragraph> <paragraph num="(4)"> <text>Notify the freestanding medical facility of its determination as soon as practicable.</text> </paragraph> </paragraph> <paragraph num="G."> <text>In deciding whether the service constitutes a hospital service subject to Commission rate regulation, Commission staff shall consider, among other things, the following criteria:</text> <paragraph num="(1)"> <text>Cost of the service;</text> </paragraph> <paragraph num="(2)"> <text>In consultation with Maryland Health Care Commission (MHCC) staff, access to and need for the service in the community;</text> </paragraph> <paragraph num="(3)"> <text>Feasibility of providing the outpatient service in the community on an unregulated basis; and</text> </paragraph> <paragraph num="(4)"> <text>Impact of the service on the All-Payer Model including, but not limited to, the Total Cost of Care limitations as prescribed in the All-Payer Model Agreement with the Center for Medicare and Medicaid Innovation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Based on the consideration of the criteria stated in §G of this regulation, the Commission staff shall make its determination on the request made under §E of this regulation within a reasonable period of time, taking into account, among other things, whether either a Certificate of Need application to establish a freestanding medical facility or a request for exemption from Certificate of Need to convert a licensed general hospital to a freestanding medical facility is pending before the MHCC and, if so, the time frame for staff to comment to MHCC on the financial feasibility of the proposed project.</text> </paragraph> <paragraph num="I."> <text>A freestanding medical facility that fails to obtain, or violates, a staff determination on the regulated status of a given service may be subject to fines for inaccurate reporting under COMAR 10.37.01.03R and paybacks for inappropriate charges made during the time a staff determination on an outpatient service was not obtained or adhered to.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Content."> <text>Each rate application shall include a list of services for which new rates are being requested, a list of the present and requested rates, and shall be based on the currently filed or required rate review system.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Method of Filing."> <text>The application may be filed by private messenger at the Offices of the Commission, or may be filed by registered mail, return receipt requested, at the following address:</text> <text>Health Services Cost Review Commission</text> <text>4160 Patterson Avenue</text> <text>Baltimore, Maryland 21215</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Docketing and Receipt."> <paragraph num="A."> <text>Docketing.</text> <paragraph num="(1)"> <text>When a valid rate application is received, as per the above regulations, it shall be entered on the Commission docket and a file opened.</text> </paragraph> <paragraph num="(2)"> <text>Each rate application shall be given an annual docket number and a consecutive page number in the docket.</text> </paragraph> <paragraph num="(3)"> <text>Each rate application shall be given a consecutive file number.</text> </paragraph> <paragraph num="(4)"> <text>A regular rate application file number shall be noted “R”.</text> </paragraph> <paragraph num="(5)"> <text>The file number of an order authorizing Commission investigation and review of established rates shall be noted “C”.</text> </paragraph> <paragraph num="(6)"> <text>A temporary rate application file number shall be noted “I”.</text> </paragraph> <paragraph num="(7)"> <text>An alternative method of rate determination application file number shall be noted “A”.</text> </paragraph> <paragraph num="(8)"> <text>A rate application file number by a new hospital or a hospital with expanded facilities or new revenue centers shall be noted “N”.</text> </paragraph> <paragraph num="(9)"> <text>The date of receipt of the rate application shall be noted on the docket and on the file.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon request of the hospital, the Commission shall give the hospital a receipt for the rate application filing, showing the docket, page, and file numbers, and the date of receiving the rate application.</text> </paragraph> <paragraph num="C."> <text>The hospital shall file an original and three copies of each rate application and its supporting documents, if any. The Commission may prescribe the format to be used in the submission of rate applications and their supporting documents. In addition, the hospital shall file with each rate application a certificate of service indicating that the application and supporting documents have been mailed or served upon all designated parties to that proceeding and upon the Commission at its offices.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Recommendations of the Commission's Staff to the Commission, Options for Commission Review."> <paragraph num="A."> <text>A rate application review shall be completed and the recommendation given to the Commission as soon as possible.</text> </paragraph> <paragraph num="B."> <text>The recommendation shall include a specification of those areas of costs which the staff believes should be reviewed. When practicable, the recommendation shall also include the amounts challenged by the staff.</text> </paragraph> <paragraph num="C."> <text>Any of four actions may be recommended to the Commission. If two or more actions are recommended, the issues and rates to be evaluated in each action shall be set forth clearly. These four actions are as follows:</text> <paragraph num="(1)"> <text>The Commission should hold a public hearing on rates;</text> </paragraph> <paragraph num="(2)"> <text>The Commission should grant tentative approval or modify all or some of the rates and publish notice of an order nisi;</text> </paragraph> <paragraph num="(3)"> <text>The Commission should hold a general hearing on rates;</text> </paragraph> <paragraph num="(4)"> <text>The Commission should deny the application in which case it shall state the grounds for the denial.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A copy of the recommendation shall be placed in the file and a copy shall be forwarded to each Commission member, the hospital, and each interested party.</text> </paragraph> <paragraph num="E."> <text>The Commission may not call for the effective date of an Order Nisi or call for a public hearing for 30 days after the Commission acts on the staff's recommendation.</text> </paragraph> <paragraph num="F."> <text>Before a staff recommendation or public hearing, the staff may hold conferences with hospital representatives and interested parties in an attempt to clarify or resolve potential issues.</text> </paragraph> <paragraph num="G."> <text>The Commission may prescribe a process for its consideration of a full rate application, which allows for written submissions in support of an application in lieu of an evidentiary hearing. A hospital that chooses this process for a Commission decision on its full rate application shall be afforded the right to submit to the Commission rebuttal information following any written response to the full rate application filed by Commission staff or designated interested parties. A hospital that chooses this written submission process waives its right to an evidentiary hearing. A hospital that chooses this written submission process does not waive its right to judicial review of a final Commission decision under the Administrative Procedure Act. As an additional alternative to an evidentiary hearing, a hospital may choose to enter into a binding arbitration process as prescribed by the Commission.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Preliminary Commission Order."> <paragraph num="A."> <text>The Commission shall consider the staff recommendation and, within 20 days of the date of the recommendation, issue its preliminary order adopting or modifying the recommendation, or referring the recommendations back to the staff for further review and subsequent recommendations.</text> </paragraph> <paragraph num="B."> <text>Order Nisi.</text> <paragraph num="(1)"> <text>If the Commission issues a preliminary order granting tentative approval of any rates, it shall publish notice of the order nisi and the rates.</text> </paragraph> <paragraph num="(2)"> <text>In addition, the Commission shall forward copies of the order nisi and the rates to the hospital and interested parties.</text> </paragraph> <paragraph num="(3)"> <text>The order nisi shall state:</text> <paragraph num="(a)"> <text>The name and address of the hospital; the names of the designated interested parties; the docket, page, and file numbers of the rate application proceeding and the date the application was filed with the Commission.</text> </paragraph> <paragraph num="(b)"> <text>An enumeration of services and the proposed representative rates to be charged:</text> </paragraph> <paragraph num="(c)"> <text>That the Commission has approved the rates as of a date to be specified, with a provision that the order may be suspended if reasonable cause is shown within 15 days of the date of the Order Nisi.</text> </paragraph> <paragraph num="(d)"> <text>That objections to the tentatively approved rates shall be submitted (in person or by mail) to the Commission in writing; that designated interested parties shall submit copies of their objections, identifying the proceeding and Order Nisi to which objections are made to the hospital, and nine copies to the Commission office; and</text> </paragraph> <paragraph num="(e)"> <text>That the file, which may contain supporting documents from the hospital, the Commission staff recommendation, the Accounting and Reporting reports and the Rate Review System of the hospital, is available at the Commission offices during regular business hours for public inspection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If the Commission issues an order for a public hearing, it shall forward copies of the order and public notice of the hearing to the hospital and the designated interested parties and shall publish a public notice of the hearing. The notice shall state:</text> <paragraph num="(1)"> <text>The name and address of the hospital: the names of the designated interested parties; the docket, page, and file numbers of the rate application proceeding; the date the application was filed with the Commission; and the time, date, and place of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>A description of the issues to be presented at the public hearing;</text> </paragraph> <paragraph num="(3)"> <text>That any person interested in the matter may attend the public hearing;</text> </paragraph> <paragraph num="(4)"> <text>That all persons wishing to present relevant testimony or a statement at the public hearing shall forward copies to the hospital, each designated interested party, and nine copies to the Commission office; that the hospital and members of the public shall forward their testimony at least 8 days before the hearing; that the designated interested parties shall forward their testimony at any time before the close of the first session.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Written testimony will not be considered unless the person submitting the testimony makes himself available for cross-examination unless stipulated to the contrary.</text> </paragraph> <paragraph num="E."> <text>If the Commission issues an order for a general hearing by the Commission, it shall forward copies of the order and public notice of the hearing to the hospital and the designated interested parties and publish a public notice of the hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Public Hearing Before the Commission."> <paragraph num="A."> <text>Testimony shall be in writing and may not be delivered orally, except as set forth in Regulation .14K, of this chapter.</text> </paragraph> <paragraph num="B."> <text>Presenting Direct Testimony.</text> <paragraph num="(1)"> <text>Any person who wishes to present direct testimony at the public hearing shall forward copies to the hospital and to every designated interested party, and shall file nine copies at the Commission's office.</text> </paragraph> <paragraph num="(2)"> <text>If the public hearing is the result of a hospital rate application pursuant to Regulation .03, of this chapter, the applicant shall file its testimony at least 20 days before the date of the hearing. The staff of the Commission and members of the public shall file their testimony at least 10 days before the date of the hearing.</text> </paragraph> <paragraph num="(3)"> <text>If the public hearing is the result of a Commission-initiated review of the rates of a hospital pursuant to Regulation .04, of this chapter, the Commission staff shall file its testimony at least 20 days before the date of the hearing. The hospital and members of the public shall file their testimony at least 10 days before the date of the hearing.</text> </paragraph> <paragraph num="(4)"> <text>The designated interested parties shall file their testimony before the close of the first hearing session.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The written direct testimony shall set forth the conclusions of the person submitting it and the arguments and facts supporting these conclusions. This testimony shall specifically pertain to the issues set forth in the public notice.</text> </paragraph> <paragraph num="D."> <text>Written direct testimony shall be verified either by:</text> <paragraph num="(1)"> <text>Appearing before an officer or other person authorized to administer an oath; or</text> </paragraph> <paragraph num="(2)"> <text>Signing the documents containing the statements required to be under oath and including the following representation: I do solemnly declare and affirm under the penalties of perjury that the facts set forth in the foregoing testimony are true and correct to the best of my knowledge, information and belief.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Copies of written direct testimony shall be forwarded by the person submitting them to the hospital and the designated interested parties.</text> </paragraph> <paragraph num="F."> <text>All written direct testimony shall pertain solely to the proposed rates and be relevant to that subject. The presiding officer shall separate irrelevant material from the remainder of the record and keep that material apart. Parts of the body of the written direct testimony judged irrelevant by the presiding officer shall be so marked and may not be considered by the Commission in its deliberations.</text> </paragraph> <paragraph num="G."> <text>Persons submitting written testimony shall make themselves available for cross-examination and may give redirect and rebuttal testimony, orally or in writing, as directed or permitted by the presiding officer.</text> </paragraph> <paragraph num="H."> <text>All testimony at public hearings shall be filed in a timely manner. Requests for hearing postponements shall be made at a reasonable time before the hearing. These requests will only be granted for valid reasons, at the discretion of the Commission. If a hospital requests a postponement of an initial hearing session after the staff has already submitted its testimony, the Commission may require the hospital to file its testimony within the time frame of the original hearing date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Conduct of Public Hearing."> <paragraph num="A."> <text>The Chairman of the Commission shall preside at the public hearing, which may be called to order when the presiding officer is in attendance. If the Chairman is absent or has been disqualified, the Vice-chairman or another commissioner shall preside.</text> </paragraph> <paragraph num="B."> <text>The Commission may direct that a hearing officer preside at the public hearing. In this case, the hearing officer may exercise all powers given to a presiding commissioner in these regulations during all sessions of the public hearing.</text> </paragraph> <paragraph num="C."> <text>At the discretion of the Commission, the specific duties of the hearing officer may include the following:</text> <paragraph num="(1)"> <text>Making all rulings as to evidence, testimony, and official notice;</text> </paragraph> <paragraph num="(2)"> <text>Setting the order for the examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(3)"> <text>Administering oaths and affirmations;</text> </paragraph> <paragraph num="(4)"> <text>Preparing both written and oral summaries of cases heard;</text> </paragraph> <paragraph num="(5)"> <text>Preparing a recommendation for the Commission consisting of a written report with findings of fact and conclusions of law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The presiding officer may adjourn a hearing to a specified time, date, and place.</text> </paragraph> <paragraph num="E."> <text>All public hearings shall be recorded and testimony shall be under oath. A transcript of the record of the hearing shall be placed in the file of the proceeding. If the hospital or any other party desires a copy of the transcript, that party shall make arrangements with the stenographer.</text> </paragraph> <paragraph num="F."> <text>All direct testimony shall be submitted in writing and in an issue-by-issue format. The hearing shall begin with the examination of the representative of the hospital and any witnesses which the hospital may desire to have testify in its behalf. Whenever practicable, the testimony of witnesses shall proceed on an issue-by-issue basis.</text> </paragraph> <paragraph num="G."> <text>The Commission's staff member assigned to the proceeding shall be the next witness to be examined on the issue in question. In a Commission initiated review, the staff member assigned to the proceeding shall be examined before the hospital witness.</text> </paragraph> <paragraph num="H."> <text>Representatives of the other interested parties who have submitted written testimony shall be examined in the order set by the presiding officer.</text> </paragraph> <paragraph num="I."> <text>The Commission may examine witnesses at any time during the course of the proceeding. Commission staff and representatives of the hospital and interested parties may also examine witnesses.</text> </paragraph> <paragraph num="J."> <text>All testimony and examination shall be relevant to the subject of the proposed rates. Redundant and irrelevant testimony and examination shall be prohibited or stricken by the presiding officer. In addition, all interested parties may move the Commission to strike redundant and irrelevant testimony.</text> </paragraph> <paragraph num="K."> <text>At the presiding officer's discretion, he may allow direct oral testimony if a person attending the hearing demonstrates good cause for not submitting the testimony in written form before the hearing. Witnesses giving direct oral testimony shall be subject to cross-examination in the same manner as other witnesses. Anyone denied an opportunity to testify may appeal in writing to the full Commission within 7 days from this denial.</text> </paragraph> <paragraph num="L."> <text>To preserve his rights on appeal or otherwise, it is not necessary for a party objecting to a Commission ruling or decision to state the grounds of his objection, unless specifically requested to do so by a member of the Commission.</text> </paragraph> <paragraph num="M."> <text>At the Commission's reasonable discretion, it may permit the filing of post hearing briefs by the hospital, the Commission staff member or any interested party. Those parties submitting briefs shall file copies within a reasonable time designated by the presiding officer to the hospital, the designated interested parties, the Commission office and to each Commission member.</text> </paragraph> <paragraph num="N."> <text>A Commission member shall remove himself from participation in a public hearing as a Commission member if he decides that a conflict of interest may appear to prejudice his evaluation of the issues considered at the public hearing. Challenges to a Commission member's participation in a public hearing as a Commission member shall be considered by the Commission, the decision made by a majority vote, excluding the member objected to. Challenges shall be made by motion, at least 7 days before the public hearing.</text> </paragraph> <paragraph num="O."> <text>Except as otherwise provided, all decisions required during the conduct of the public hearing shall be made by the presiding officer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Decision and Opinions of the Commission."> <paragraph num="A."> <text>The decision and the opinions of the Commission shall be based solely on the testimony, examination, and evidence presented at the public hearing, on the briefs filed, if any, on the evidence incorporated into the record of the proceeding by reference, on information and data in the record of the proceeding, and on matters as to which the Commission has taken official notice, which matters shall be made known to the parties to the proceedings.</text> </paragraph> <paragraph num="B."> <text>The deliberations of the Commission may be held in private executive session.</text> </paragraph> <paragraph num="C."> <text>The decision shall be made by a majority of the Commission members attending all sessions of the public hearing, or having read the record of hearings they did not attend.</text> </paragraph> <paragraph num="D."> <text>The decision shall be in writing and shall be based on a written majority or unanimous opinion stating the reasons and grounds for the Commission's decision. If a majority of Commissioners who are to render the final decision have not heard the evidence, the decision, if adverse to a party to the proceeding other than the Commission itself, may not be made until a proposal for decision, including findings of fact and conclusions of law, has been served upon the parties, and an opportunity has been afforded to each party adversely affected to file exceptions and present argument to a majority of the Commissioners who are to render the decision, who shall personally consider the whole record or those portions of it as may be cited by the parties.</text> </paragraph> <paragraph num="E."> <text>At the discretion of a Commission member (or members) who agrees with the decision reached by the majority of the Commission, but who does not agree with the majority opinion, or any part of it, the Commission member (or members) may file a written concurring opinion.</text> </paragraph> <paragraph num="F."> <text>A commission member (or members) who does not agree with the decision or any part of it reached by the majority of the Commission may, at his discretion, file a written dissenting opinion.</text> </paragraph> <paragraph num="G."> <text>The Commission's decision and the opinion (or opinions) shall be filed promptly and the Commission's staff then shall forward copies of the Commission's decision and the opinion (or opinions) to the hospital, to the designated interested parties, and to those parties who submitted written direct testimony before the public hearing.</text> </paragraph> <paragraph num="H."> <text>The Commission shall then publish:</text> <paragraph num="(1)"> <text>An order approving, modifying, or disapproving the rates under review in the proceeding:</text> </paragraph> <paragraph num="(2)"> <text>A notice that copies of the Commission's decision and the opinion (or opinions) may be obtained by written request to the Commission offices; and</text> </paragraph> <paragraph num="(3)"> <text>A notice that the record of the complete proceeding is open for public inspection at the Commission offices during regular business hours.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="General Hearing Before the Commission."> <paragraph num="A."> <text>To obtain general information from the region and community in which a hospital is located, the Commission, at its discretion, may hold a general hearing during the course of any rate proceeding.</text> </paragraph> <paragraph num="B."> <text>A general hearing shall be supplementary to other methods of rate review and may not replace them.</text> </paragraph> <paragraph num="C."> <text>A general hearing shall be held in the region in which the hospital whose rates are being reviewed is located.</text> </paragraph> <paragraph num="D."> <text>The public notice of a general hearing may state:</text> <paragraph num="(1)"> <text>The name and address of the hospital, the designated interested parties, the docket, page, and file numbers of the application, and the time, date, and place of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>A description of the issues to be considered at the general hearing;</text> </paragraph> <paragraph num="(3)"> <text>That any party interested in the matter may attend and present written or oral statements concerning the announced issues; and</text> </paragraph> <paragraph num="(4)"> <text>That presentations may be limited as to time and that the number of spokespersons representing any group or organization may be limited.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The general hearing shall be conducted by a hearing officer, any member of the Commission, a senior member of the Commission staff or its legal counsel.</text> </paragraph> <paragraph num="F."> <text>Persons attending the general hearing may present written or oral statements concerning the issues and rates set forth in the notice, which statements need not be verified. The presiding officer, within his discretion, may limit the number of spokespersons representing a group or organization and may limit the time allowed for oral statements.</text> </paragraph> <paragraph num="G."> <text>The conduct of the general hearing shall be recorded and the transcript shall be placed in the file of the proceedings. Any person may purchase a transcript of the hearing from the stenographer.</text> </paragraph> <paragraph num="H."> <text>The presiding officer may ask questions of the spokespersons. Within the discretion of the presiding officer, examination or questions of the spokespersons by other persons may be permitted.</text> </paragraph> <paragraph num="I."> <text>A transcript of the oral statements and copies of the written statements shall be placed in the Commission's file of the particular rate review proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Forms."> <text>The following forms are illustrative of pleadings and papers commonly used by parties in rate review proceedings and should be used wherever possible and, if necessary, adapted to the facts in the proceeding and the needs of the party using the forms:</text> <paragraph num="A."> <text>Rate Application.</text> </paragraph> <paragraph num="B."> <text>Public Notice of Rate Proceeding.</text> </paragraph> <paragraph num="C."> <text>Notice of Public Hearing.</text> </paragraph> <paragraph num="D."> <text>Notice of General Hearing:</text> </paragraph> <paragraph num="E."> <text>Notice of Orders Nisi.</text> </paragraph> <paragraph num="F."> <text>Order Nisi.</text> </paragraph> <paragraph num="G."> <text>Orders.</text> </paragraph> <paragraph num="H."> <text>Motions.</text> </paragraph> <paragraph num="I."> <text>Service.</text> </paragraph> <text>________________________________________________________________________________________________________</text> <text>(Signature of party filing pleading)</text> <paragraph num="J."> <text>Subpoena Duces Tecum for Rate Review.</text> </paragraph> <text>__________ (date) ________________________________________________________________________________________</text> <text>Health Services Cost Review Commission</text> <paragraph num="K."> <text>Summons for Rate Review.</text> </paragraph> <text>__________ (date) ________________________________________________________________________________________</text> <text>Health Services Cost Review Commission</text> <paragraph num="L."> <text>Summons for Hearing.</text> </paragraph> <text>__________ (date) ________________________________________________________________________________</text> <text>Health Services Cost Review Commission</text> <paragraph num="M."> <text>Subpoena Duces Tecum for Hearing.</text> </paragraph> <text>__________ (date) ________________________________________________________________________________________</text> <text>Health Services Cost Review Commission</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Format."> <paragraph num="A."> <text>All pleadings, motions, and other papers filed in a Commission proceeding shall be typed or legibly written on sheets of bond paper not more than 11 inches long or 8-1/2 inches wide, and each paper shall have a left margin of at least 1 inch and a top margin of at least 1-1/2 inches.</text> </paragraph> <paragraph num="B."> <text>All pleadings, motions, and other papers, excluding exhibits appended to the pleadings, shall contain a heading at the top of the first page and, excluding appended exhibits and written direct testimony for a public hearing, a certificate of service at the bottom of the last page.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Filing of a Rate Application."> <paragraph num="A."> <text>A rate application filed by private messenger at the offices of the Commission shall be deemed to be filed on the date the application is received during normal working hours in the Commission's office.</text> </paragraph> <paragraph num="B."> <text>A rate application sent by registered mail shall be deemed to be filed 3 days after the application is placed in the U.S. Postal Service, these days to exclude Saturdays, Sundays, and holidays on which mail is not delivered to the Commission. The rate application's file date shall be entered on the docket of the proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Service."> <text>An original and three copies of all other pleadings, documents, testimony, or motions to be considered by the Commission shall be filed at the office of the Commission during regular business hours. All pleadings, documents, testimony, or motions shall contain a certificate of service indicating that the pleading, document, testimony, or motion has been mailed or served upon all designated parties to that proceeding and upon the Commission at its offices.</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Computations of Time Periods and Extensions."> <paragraph num="A."> <text>In computing any period of time prescribed by these regulations, by order of the Commission or by any applicable statute, the day of the action or default initiating the designated period of time not be included. The last day of the period so computed is to be included unless it is a day on which the office of the Commission is closed, in which event the period runs until the end of the next day on which the office of the Commission is open. When the period of time allowed is more than 5 days, intermediate Saturdays, Sundays, and legal holidays shall be considered in the same manner as other days, but if the period of time allowed is 5 days or less, intermediate Saturdays, Sundays, and legal holidays may be not counted in computing the period of time.</text> </paragraph> <paragraph num="B."> <text>At the discretion of the Executive Director or his designee and, upon reasonable cause being shown by the submitting party, a period of time to submit a document or perform any other act permitted or prescribed by these regulations may be extended for a reasonable period of time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Motions."> <paragraph num="A."> <text>Motions shall be in writing, except when made at a hearing or conference and shall state concisely the question which the Commission is called upon to determine, or the action the movant desires the Commission to take. It shall state all reasons, authorities, and citations in the body of the motion or in a supporting memorandum. A certificate of service, setting forth all parties upon whom a copy of the motion was served, shall be attached to the motion.</text> </paragraph> <paragraph num="B."> <text>The following actions shall be taken by motion:</text> <paragraph num="(1)"> <text>Objections to actions of the Commission, or the Commission's staff; motions for clarification or reconsideration may not stay the orders of the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Demands for actions which the movant desires the Commission, or the Commission's staff to take;</text> </paragraph> <paragraph num="(3)"> <text>Showing reasonable cause why an Order Nisi should not become effective;</text> </paragraph> <paragraph num="(4)"> <text>Presenting a proper and justifiable question to the Commission;</text> </paragraph> <paragraph num="(5)"> <text>Objections to the introduction of statements or other evidence by another party during a proceeding;</text> </paragraph> <paragraph num="(6)"> <text>Challenges to members of the Commission;</text> </paragraph> <paragraph num="(7)"> <text>Proposals for stipulations;</text> </paragraph> <paragraph num="(8)"> <text>Answers to prior motions; and</text> </paragraph> <paragraph num="(9)"> <text>All other actions which might be initiated properly or undertaken by a party to a proceeding and which are not otherwise provided for in these regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The motion shall be filed with the Commission and a copy shall be served on each affected party.</text> </paragraph> <paragraph num="D."> <text>A motion need not be verified unless it is based upon facts not apparent from the record or documents filed in the proceeding.</text> </paragraph> <paragraph num="E."> <text>Any affected party may answer an initial motion.</text> </paragraph> <paragraph num="F."> <text>The method of considering the motion, whether by executive communication, private hearing, or public hearing shall be determined by the chairman of the Commission.</text> </paragraph> <paragraph num="G."> <text>The Commission shall decide upon the question presented or action demanded in the motion in an equitable manner and as soon as practicable.</text> </paragraph> <paragraph num="H."> <text>Except when a motion is made at a conference or a hearing, the order granting or denying the motion shall be in writing and shall be entered on the record of the proceeding and copies of the order shall be served upon the moving party and all affected parties.</text> </paragraph> <paragraph num="I."> <text>The decision expressed in the order shall be decided pursuant to these regulations, if provision is made. If no provision is made, the motion shall be decided by a majority of the Commission. However, motions made in the course of a private conference or at a public hearing shall be decided by the presiding officer or a majority of the Commission attending the session of the conference or hearing at which the motion was made, as provided elsewhere in these regulations. Motions made in the course of a general hearing shall be decided by the hearing officer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Subpoenas."> <paragraph num="A."> <text>At any time, the Commission may issue subpoenas directing a designated person to do the following:</text> <paragraph num="(1)"> <text>Appear to testify at a hearing or private pre-hearing conference conducted by the Commission:</text> </paragraph> <paragraph num="(2)"> <text>Appear at a specified time and date at the Commission offices or any designated place within the State, and, under oath or otherwise, give testimony and answer questions of the Commission or its authorized representatives; or</text> </paragraph> <paragraph num="(3)"> <text>Produce documents, reports, or records of a particular activity for a specific period of time if he has custody of or access to the documents, reports, or records; the records may be in any reasonable form; the production shall be made at a specified time, date, and place.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A subpoena shall be in whatever form is prescribed by the Commission and shall include:</text> <paragraph num="(1)"> <text>The name, title, if any, and address of the person upon whom it is to be served and the address at which it is to be served;</text> </paragraph> <paragraph num="(2)"> <text>The name(s), title(s), or position(s) of the witness(es) who shall appear and the time, date and place of their appearance.</text> </paragraph> <paragraph num="(3)"> <text>A reasonable specification of the documents, reports and/or records, if any, to be produced at the designated time, date and place.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Subpoenas shall be served at least 7 days before any public hearing or private or pre-hearing conference or executive session of the Commission at which the witness or witnesses are directed to appear, and shall be served at least 3 days before a private appointment.</text> </paragraph> <paragraph num="D."> <text>Subpoenas shall be served in person by a person designated by the executive director or, at his discretion, by registered or certified mail, return receipt requested. A signed return of the service or the return receipt shall be entered in the file and noted on the docket of the proceeding.</text> </paragraph> <paragraph num="E."> <text>A witness or a party with whom he is associated or affiliated may move to quash or modify the subpoena directed to him at any time before the date set for his appearance by filing with the Commission a motion to quash or modify the subpoena as provided in that section which pertains to motions in general.</text> </paragraph> <paragraph num="F."> <text>Failure to appear or to produce documents in accordance with a subpoena shall subject the witness or the party with which he is affiliated or associated to a finding of contempt by the Commission and other penalties provided by law or these regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Effective Dates and Suspensions."> <paragraph num="A."> <text>The effective date of rates applied for in a rate application shall be 30 days from the date of the filing of the rate application with the Commission and shall be specified in the rate application.</text> </paragraph> <paragraph num="B."> <text>The Commission's staff may recommend the suspension of the effective date of the rates under review.</text> </paragraph> <paragraph num="C."> <text>At any time during a rate review, the Commission may order a suspension of the effective date of the rates under review, within the time specifications of Health-General Article, §19-219, Annotated Code of Maryland, and shall state the grounds for its action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Evidence, Testimony, and Official Notice."> <paragraph num="A."> <text>The presiding officer at a public hearing or general hearing shall make all rulings as to evidence, testimony, and official notice and he may call on the legal counsel of the Commission for guidance in his rulings.</text> </paragraph> <paragraph num="B."> <text>All evidence and testimony shall be relevant and pertain solely to the issues being considered in a particular proceeding.</text> </paragraph> <paragraph num="C."> <text>Redundant evidence or testimony may not be permitted at public or general hearings or in the records of proceedings.</text> </paragraph> <paragraph num="D."> <text>Non-expert opinion testimony may be considered at a hearing and documentary opinion evidence may be entered in the record of a proceeding if the testimony or evidence is based on facts and matters admissible into evidence and the facts and matters are within the personal knowledge of the submitter of the document.</text> </paragraph> <paragraph num="E."> <text>Qualification as an expert shall be within the discretion of the presiding officer of the public or general hearing at which the proposed expert may proffer testimony or evidence or, if evidence is proffered at a time other than at a public hearing, within the discretion of the chairman of the Commission considering the proceeding. The expert qualification need not be based upon academic degrees or learning; reasonably extensive practical experience with the subject may be sufficient for an expert qualification.</text> </paragraph> <paragraph num="F."> <text>Subject to the provisions of these regulations, legal rules of evidence shall be followed as far as practicable at public and general hearings.</text> </paragraph> <paragraph num="G."> <text>Reliable and probative documents previously filed with or compiled by the Commission or its staff or consultants that are relevant to issues being considered by the Commission may be incorporated by reference into the record of a proceeding by the Commission or, by leave of the presiding officer, by a party to the proceeding.</text> </paragraph> <paragraph num="H."> <text>In the course of a proceeding, the Commission may take official notice of facts and matters in the same manner as the courts of the State take judicial notice of facts and matters and, additionally, may take notice, without meeting formal evidentiary rules, of general, technical, or scientific facts within the specialized knowledge of a member of the Commission. However, any party to the proceeding is entitled, on timely request, to an opportunity to show that the Commission should not take official notice of specific facts and matters or that the fact or matter to be officially noticed is inapplicable to the proceeding or is incorrect or misunderstood by the Commission.</text> </paragraph> <paragraph num="I."> <text>In reviewing a hospital's rate structure, the Commission may consider or take official notice of any public document, including, but not limited to, any filing made with the Maryland Health Resources Planning Commission relative to a Certificate of Need application including all projections of volumes, revenues, rates, and feasibility studies, as well as any public document concerning the financing of a project approved pursuant to a Certificate of Need.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Working Capital Differentials — Payment of Charges."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Debt collector” has the meaning stated in COMAR 10.37.13.01.</text> </paragraph> <paragraph num="(b)"> <text>“Hospital” means a “facility” as defined in Health-General Article, §19- 301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(c)"> <text>“Income-based payment plan” means a payment plan based on the patient’s household income as set forth in COMAR 10.37.13.05.</text> </paragraph> <paragraph num="(d)"> <text>“Payment plan” has the meaning stated in COMAR 10.37.13.01.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A third-party payer may obtain a discount in rates established by the Commission if it provides current financing monies in accordance with the following terms.</text> <paragraph num="(1)"> <text>A third-party payer that provides current financing equal to the average amount of outstanding charges for bills from the end of each regular billing period and for discharged patients shall be entitled to a 2-percent discount. For purposes of this regulation, a regular billing period shall be based on a 30-day billing cycle. The current financing provided in here corresponds to a third party's paying on discharge.</text> </paragraph> <paragraph num="(2)"> <text>A third-party payer that provides current financing equal to the average amount of outstanding charges for discharged patients plus the average daily charges times the average length of stay, shall be entitled to a 2.25-percent discount. The current financing provided to hospitals corresponds to a third party's paying on admission.</text> </paragraph> <paragraph num="(3)"> <text>Outstanding charges shall be calculated by an amount equal to the hospital’s current average daily payment by the payer, multiplied by the hospital’s and third party payer’s processing and payment time. The precise calculation shall be made in accordance with the guidelines specified by Commission staff.</text> </paragraph> <paragraph num="(4)"> <text>Upon request from an applicant, the Commission may approve an alternative method of calculating current financing monies.</text> </paragraph> <paragraph num="(5)"> <text>The third-party payer shall adjust the current financing advance to reflect Commission rate orders and changes in volume associated with the particular payer and hospital. This adjustment shall be made within 45 days of a rate order or at such other time as circumstances warrant. In the absence of a rate order, the adjustment shall be made at least annually.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The third-party payer shall promptly provide the Commission with a verified record of the detailed calculation of the current financing and of each recalculated balance as adjustments are made. The detailed calculations shall become a part of the public record. The Commission may, at any time, evaluate the amount of current financing monies provided to a hospital to assure that it meets the discount of requirements specified in §B of this regulation. If the Commission finds that the amount of current financing is inconsistent with the requirements of §B of this regulation, the Commission may, at its sole discretion, require an adjustment to the working capital advance or to the discount.</text> </paragraph> <paragraph num="D."> <text>Discounts.</text> <paragraph num="(1)"> <text>A payer or self-paying patient, who does not provide current financing under §B of this regulation, shall receive a 2-percent discount if payment is made at the earlier of the end of each regular billing period or upon discharge from the hospital.</text> </paragraph> <paragraph num="(2)"> <text>Payment within 30 days of the earlier of the end of each regular billing period or discharge entitles a payer or self-pay patient to a 1-percent discount.</text> </paragraph> <paragraph num="(3)"> <text>For those payers not subject to Insurance Article, §15-1005, Annotated Code of Maryland, after 60 days from the date of the earlier of the end of each regular billing period or discharge, interest or late payment charges may accrue on any unpaid charges at a simple rate of 1 percent per month.</text> </paragraph> <paragraph num="(4)"> <text>The interest or late payment charges may be added to the charge on the 61st day after the date of the earlier of the end of each regular billing period or discharge and every 30 days after that.</text> </paragraph> <paragraph num="(5)"> <text>For patients that have entered into a hospital income-based payment plan under COMAR 10.37.13.05, the interest rate shall be established in accordance with the Guidelines set forth in COMAR 10.37.13.05.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Hospital Billing Responsibilities.</text> <paragraph num="(1)"> <text>A patient shall be given a bill for services at the earlier of the end of each regular billing period or upon discharge or dismissal, when dismissal for outpatients is analogous to discharge for inpatients.</text> </paragraph> <paragraph num="(2)"> <text>This bill shall cover substantially all care rendered and should, except for some last day ancillary services and excepting arithmetic errors, represent the full charge for the patient's care.</text> </paragraph> <paragraph num="(3)"> <text>A notice shall be posted prominently at the billing office of the hospital clearly notifying all patients of the availability of the discounts referred to in §D of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>The bill and the notice shall state that the patient shall receive a 2-percent discount by paying upon discharge or a 1-percent discount by paying within 30 days of discharge.</text> </paragraph> </paragraph> <paragraph num="F."> <text>GME Discounts. In those instances where a teaching hospital is reimbursed separately for the costs associated with the provision of graduate medical education (GME), the Commission shall calculate the percentage of the hospital's rates that these GME payments represent and provide notice of the amounts that may be credited toward the payment for services rendered. At all times, total payment received by the teaching hospital shall be in accordance with Commission-approved rates.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-1" heading="Maryland Health Insurance Plan (MHIP) Assessment."> <paragraph num="A."> <text>The Commission shall determine and assess those funds necessary to operate and administer the MHIP. The Commission shall adjust hospital rates to implement the revenue neutral assessment.</text> </paragraph> <paragraph num="B."> <text>The Commission shall assess each hospital up to 1 percent of its net patient revenue to operate and administer the MHIP. There shall be no MHIP assessment for Fiscal Year 2016.</text> </paragraph> <paragraph num="C."> <text>Beginning on September 5, 2003, each hospital whose rates have been approved by the Commission shall remit monthly, by the 5th of each month, 1/12 of its total share of the annual funding assessment determined by the Commission to be owed by the hospital to the Maryland Health Insurance Plan Fund as established under Insurance Article, Title 14, Subtitle 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A hospital that fails to remit its funding assessment due in a timely manner may be subject to an annualized interest charge of 3 percentage points above the most recent average prime rate of interest, as published in the “Money Rates” section of The Wall Street Journal, on the unpaid balance. In addition, the Commission may impose penalties of up to 5 percent of the amount of any underpayment made by the hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-2" heading="Assessment for Savings in Averted Uncompensated Care."> <paragraph num="A."> <text>Beginning July 1, 2008, the Commission shall assess annually a uniform, broad-based, and reasonable amount in hospital rates to reflect the aggregate reduction in hospital uncompensated care resulting from the expansion of health care coverage under Ch. 7, Acts of 2007 Special Session.</text> </paragraph> <paragraph num="B."> <text>Given the prospective nature of the rate system, the Commission shall ensure that the assessment amount does not exceed the savings projected in averted hospital uncompensated care from the health care coverage expansion. The Commission shall notify hospitals annually of the amount to be assessed by July 1 of each year, to be effective July 1.</text> </paragraph> <paragraph num="C."> <text>Beginning September 2008, on or before the 5th business day of each month, each hospital assessed in accordance with Health-General Article §19-214, Annotated Code of Maryland, and the provisions of this regulation shall make payment into the Health Care Coverage Fund established under Health-General Article, §15-701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A hospital that fails to remit its monthly funding assessment in a timely manner may be subject to an annualized interest charge of 3 percent the most recent average prime rate of interest, as published in the “Money Rates” section of the Wall Street Journal, on the unpaid balance. In addition, the Commission may impose penalties of up to 5 percent of the amount of any underpayment made by the hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Designated Interested Parties."> <paragraph num="A."> <text>Designated interested parties for a specific rate review proceeding may include:</text> <paragraph num="(1)"> <text>Those community oriented groups which the Commission determines have a significant interest in the hospital and its rate application;</text> </paragraph> <paragraph num="(2)"> <text>Those third-party payors or their representatives who have been designated by the Commission as interested parties for this proceeding;</text> </paragraph> <paragraph num="(3)"> <text>The hospital whose rates are being reviewed;</text> </paragraph> <paragraph num="(4)"> <text>Maryland Health and Higher Educational Facilities Authority for rate review proceedings concerning hospitals with capital financing through the Authority.</text> </paragraph> <paragraph num="(5)"> <text>Group Hospitalization, Incorporated, for rate review proceedings concerning hospitals with which it has contractual relations; and</text> </paragraph> <paragraph num="(6)"> <text>Legal Aid Bureau of Baltimore City.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Designated interested parties for all rate applications are:</text> <paragraph num="(1)"> <text>Provider Reimbursement Department of Blue Cross of Maryland, Inc.;</text> </paragraph> <paragraph num="(2)"> <text>Medical Care Programs Administration of the Maryland Department of Health (Medicaid);</text> </paragraph> <paragraph num="(3)"> <text>Division of Provider Reimbursement and Accounting Policy, Bureau of Health Insurance, Social Security Administration, Department of Health, Education and Welfare of the United States (Medicare); and</text> </paragraph> <paragraph num="(4)"> <text>Health Insurance Association of America.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Right to Counsel."> <text>A hospital or any other party in a rate review proceeding may be represented by legal counsel at any or all times during the proceeding, but there is no requirement that parties have legal counsel.</text> </regulation> <regulation prefix="Regulation" num=".29" heading="Challenges."> <paragraph num="A."> <text>Any party to a proceeding may challenge the ability of any member of the Commission to consider the rates or issues in that proceeding. Excepting private conferences, this challenge shall be made during the proceeding before its first hearing. Challenges may not be permitted after the first hearing, except in extraordinary circumstances.</text> </paragraph> <paragraph num="B."> <text>A challenge shall be verified in writing, specifying the member of the Commission and shall set forth all its reasons. The challenge shall be filed with the Commission and entered upon the record of the proceeding.</text> </paragraph> <paragraph num="C."> <text>A copy of the challenge shall be forwarded to the challenged member immediately after it is filed, and he may make whatever response he deems proper and necessary.</text> </paragraph> <paragraph num="D."> <text>The challenge shall be denied or allowed by a majority of the Commission, excluding the challenged member. The order based on the decision shall be filed with the Commission, entered in the record of the proceeding and served on the challenged member and the challenging party.</text> </paragraph> <paragraph num="E."> <text>If a challenge to a Commission member is allowed, he immediately shall cease all participation in the proceeding in question as a Commission member.</text> </paragraph> <paragraph num="F."> <text>The allowance of a challenge to a member of the Commission may not, in itself, disqualify him from serving as a Commission member in other matters and proceedings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Consolidation."> <text>When two or more rate proceedings involve common questions of fact, the Commission, upon a majority vote of its members, may order that the common questions of fact be decided in a consolidated proceeding.</text> </regulation> <regulation prefix="Regulation" num=".31" heading="Burden of Proof."> <paragraph num="A."> <text>In proceedings initiated by a regular, temporary, or new hospital rate application, the burden of proof of the reasonableness, equity, and lack of undue discrimination of the proposed rates shall rest with the hospital.</text> </paragraph> <paragraph num="B."> <text>In proceedings initiated by an application for an alternative method of rate determination, the burden of proof of the applicability of the alternative method of rate review to the hospital shall rest with the hospital.</text> </paragraph> <paragraph num="C."> <text>In proceedings initiated by an order for Commission review of established rates, the burden of proof of the reasonableness, equity, and lack of undue discrimination of the established rates under review shall rest with the hospital.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Severability."> <text>If any section or provision of these regulations is declared unconstitutional or void by any court of competent jurisdiction, or its applicability to any person or circumstances is held invalid, the constitutionality or validity of the remainder of the regulations and the applicability to other persons and circumstances are not affected, and to this end, the sections and provisions of these regulations are declared to be severable.</text> </regulation> <regulation prefix="Regulation" num=".33" heading="Petition for Promulgation, Amendment, or Repeal of Regulation."> <paragraph num="A."> <text>Any interested party may file with the Commission a petition for the promulgation, amendment, or repeal of a regulation designed to implement, interpret, or prescribe law, policy, organization, procedure, or practice requirements of the Commission. The petition shall set forth:</text> <paragraph num="(1)"> <text>The interest of the petitioner and the nature of the relief desired;</text> </paragraph> <paragraph num="(2)"> <text>Any facts, views, arguments, and data deemed relevant by the petitioner;</text> </paragraph> <paragraph num="(3)"> <text>Verification under oath by the party or by a duly authorized officer or agent of the party, whose address and title shall be stated.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the petition is for the promulgation of a regulation, a copy of the proposed regulation shall be attached.</text> </paragraph> <paragraph num="C."> <text>If the petition is for the amendment of a regulation, a copy of the amended regulation shall be attached with new matters underlined and matters to be deleted bracketed.</text> </paragraph> <paragraph num="D."> <text>In addition to and accompanying the original of the petition filed with the Commission, there shall be 12 copies for use of the Commission and other interested parties.</text> </paragraph> <paragraph num="E."> <text>The Commission shall consider the petition as well as all comments relating to it by interested parties. Within 30 days from the filing of the petition, the Commission shall render a decision:</text> <paragraph num="(1)"> <text>Denying the petition and stating the reasons therefor; or</text> </paragraph> <paragraph num="(2)"> <text>Submitting the proposed action to the Maryland Register for notice to, and comments by, all interested parties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Petition for Declaratory Ruling."> <paragraph num="A."> <text>An interested person may file with the Commission a petition for a declaratory ruling with respect to the manner in which the Commission would apply a statute that the Commission enforces, a regulation of the Commission, or an order of the Commission, to a person or property on the facts set forth in the petition.</text> </paragraph> <paragraph num="B."> <text>The petition for a declaratory ruling shall be filed in writing and shall contain a statement describing in detail the interest of the petitioner in making the request, the issues involved, a statement of the facts, a listing of documents or statements, or both, to be considered, and a sworn statement by the petitioner that the facts contained there are true to the best of the person's knowledge and belief.</text> </paragraph> <paragraph num="C."> <text>Sixty days from the receipt of the petition the Commission shall inform the petitioner whether the petition will be granted. If the petition is not granted the Commission shall inform the petitioner in writing of the reasons for the denial. If the petition is granted, the Commission shall inform the petitioner when to expect the declaratory ruling.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Consideration and Disposition."> <paragraph num="A."> <text>Consideration.</text> <paragraph num="(1)"> <text>The petition shall be granted whenever the Commission deems issuing a declaratory ruling advisable under the circumstances.</text> </paragraph> <paragraph num="(2)"> <text>In rendering its declaratory ruling, the Commission:</text> <paragraph num="(a)"> <text>Shall consider all the materials submitted with the petition; or</text> </paragraph> <paragraph num="(b)"> <text>May, in its discretion:</text> <paragraph num="(i)"> <text>Consult individuals or materials outside the corners of the petition; or</text> </paragraph> <paragraph num="(ii)"> <text>Require argument of the question or permit the introduction of evidence.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Disposition.</text> <paragraph num="(1)"> <text>A declaratory ruling issued shall be in writing, stating the:</text> <paragraph num="(a)"> <text>Issue;</text> </paragraph> <paragraph num="(b)"> <text>Conclusion;</text> </paragraph> <paragraph num="(c)"> <text>Facts upon which the conclusion was based; and</text> </paragraph> <paragraph num="(d)"> <text>Sources relied upon.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A declaratory relief issued by the Commission shall plainly state on its face that it is a declaratory ruling pursuant to this regulation.</text> </paragraph> <paragraph num="(3)"> <text>A written answer from the Commission to an inquiry may not be construed as a declaratory ruling unless made in conformity with these regulations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Publication and Inspection. The Commission:</text> <paragraph num="(1)"> <text>Shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to statute or statutes or regulation or regulations involved.</text> </paragraph> <paragraph num="(2)"> <text>May publish a declaratory ruling of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Denial of a Petition for Declaratory Ruling. A petition may be denied if the:</text> <paragraph num="(1)"> <text>Request contains incomplete information upon which to base an informed declaratory ruling;</text> </paragraph> <paragraph num="(2)"> <text>Commission concludes that a declaratory ruling cannot reasonably be given on the matter;</text> </paragraph> <paragraph num="(3)"> <text>Matter is adequately covered by a prior regulation, declaratory ruling, decision, or legal opinion; or</text> </paragraph> <paragraph num="(4)"> <text>Commission concludes that a declaratory ruling would not be in the public interest.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Effect and Appeal."> <paragraph num="A."> <text>Effect.</text> <paragraph num="(1)"> <text>A declaratory ruling shall be binding upon the Commission and the petitioner on the statement of facts covered in the declaratory ruling and set forth in the petition.</text> </paragraph> <paragraph num="(2)"> <text>After notice and an opportunity to reply, a declaratory ruling may be reconsidered, amended, altered, or revoked by the Commission.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§15-601 et seq. and 19-201, 19-207, 19-210—19-214, 19-214.1, 19-214.2, 19-214.3, 19-216—19-220, and 19-222; Insurance Article, §§14-501, 14-502, and 14-504; State Government Article, §10-304(b); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 7, 1974 (1:4 Md. R. 177)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective August 20, 1975 (2:18 Md. R. 1234)</annotation> <annotation type="History" subtype="Administrative History">Regulation .100 adopted effective December 10, 1975 (2:28 Md. R. 1680)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 27, 1976 (3:22 Md. R. 1250)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 8, 2004 (31:22 Md. R. 1595)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01I, J adopted effective January 8, 1990 (16:26 Md. R. 2794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01K adopted effective May 12, 2003 (30:9 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 14, 1987 (14:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective June 15, 1998 (25:14 Md. R. 1127); emergency status expired December 15, 1998</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 5, 2002 (29:15 Md. R. 1142); January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective July 1, 2000 (27:17 Md. R. 1616); emergency status extended at 27:26 Md. R. 2356; emergency status extended at 28:7 Md. R. 687; emergency status expired July 1, 2001</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 7, 2005 (32:22 Md. R. 1756); October 8, 2007 (34:20 Md. R. 1740); April 11, 2016 (43:7 Md. R. 450); January 16, 2017 (44:1 Md. R. 12); December 13, 2021 (48:25 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective November 3, 2022 (49:25 Md. R. 1048); emergency provision expired May 1, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective September 1, 2003 (30:17 Md. R. 1203); March 15, 2004 (31:5 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C adopted effective November 19, 1984 (11:23 Md. R. 1993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective October 3, 1988 (15:20 Md. R. 2334)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective January 8, 1990 (16:26 Md. R. 2794)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D recodified as .03C effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted as an emergency provision effective January 1, 2004 (31:4 Md. R. 313); adopted permanently effective May 10, 2004 (31:9 Md. R. 713)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended as an emergency provision effective July 1, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective November 8, 2004 (31:22 Md. R. 1595)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1A amended effective January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1B amended effective May 8, 2006 (33:9 Md. R. 796); April 11, 2016 (43:7 Md. R. 450)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 15, 1979 (6:12 Md. R. 1050)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 adopted as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); adopted permanently effective February 8, 1999 (26:3 Md. R. 175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 amended as an emergency provision effective May 21, 2001 (28:13 Md. R. 1214); amended permanently effective September 3, 2001 (28:17 Md. R. 1557)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-1 amended effective January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 adopted effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2 amended effective April 30, 2001 (28:8 Md. R. 760); January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2A, C amended effective January 12, 2009 (36:1 Md. R. 22)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-2C amended effective October 9, 2006 (33:20 Md. R. 1617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-3 adopted effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04-3 amended effective April 30, 2001 (28:8 Md. R. 760); January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2000 (27:17 Md. R. 1617); amended permanently effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 3, 2001 (28:17 Md. R. 1557)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended as an emergency provision effective November 3, 2022 (49:25 Md. R. 1048); emergency provision expired May 1, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective August 28, 1995 (22:17 Md. R. 1318)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective September 9, 1996 (23:18 Md. R. 1317); November 4, 1996 (23:22 Md. R. 1497); February 9, 1998 (25:3 Md. R. 146)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E recodified to .06F and new .06E adopted effective October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective March 4, 2013 (40:4 Md. R. 346)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G adopted effective October 9, 2006 (33:20 Md. R. 1617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 31, 1977 (4:18 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1 adopted effective September 10, 2007 (34:18 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1A amended effective December 13, 2021 (48:25 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1C amended effective December 21, 2015 (42:25 Md. R. 1544); May 9, 2016 (43:9 Md. R. 530)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1E amended effective May 14, 2012 (39:9 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-1K, L adopted effective December 13, 2021 (48:25 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07-2 adopted effective January 16, 2017 (44:1 Md. R. 12)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective April 9, 1984 (11:7 Md. R. 626); March 8, 1999 (26:5 Md. R. 391); December 21, 2015 (42:25 Md. R. 1544)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11C and .12B amended effective May 29, 1981 (8:11 Md. R. 975)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G adopted effective January 15, 2018 (45:1 Md. R. 14)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13B amended effective September 19, 1980 (7:19 Md. R. 1806)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13H adopted effective July 28, 1978 (5:15 Md. R. 1190) (originally codified as Regulation .12G)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14I amended effective December 12, 2002 (29:24 Md. R. 1919)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective April 9, 1984 (11:7 Md. R. 626); March 8, 1999 (26:5 Md. R. 391)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective May 11, 1977 (4:10 Md. R. 767)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25I adopted effective May 9, 1983 (10:9 Md. R. 791)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended as an emergency provision effective June 19, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1530)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective November 15, 2010 (37:23 Md. R. 1611); December 11, 2025 (52:24 Md. R. 1198)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended effective July 1, 1988 (15:13 Md. R. 1555); April 3, 1989 (16:6 Md. R. 728); November 26, 1990 (17:23 Md. R. 2732); March 30, 1992 (19:6 Md. R. 674); June 7, 1993 (20:11 Md. R. 913); July 5, 1993 (20:13 Md. R. 1049); August 1, 1994 (21:15 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended as an emergency provision effective June 1, 1996 (23:13 Md. R. 938); emergency status expired November 13, 1996</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended December 30, 1996 (23:26 Md. R. 1860)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended as an emergency provision effective November 24, 1997 (24:26 Md. R. 1752); emergency status extended to August 31, 1998 (25:12 Md. R. 943); emergency status extended to October 31, 1998 (25:18 Md. R. 1431)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended October 5, 1998 (25:20 Md. R. 1531)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended as an emergency provision effective February 25, 1999 (26:6 Md. R. 480); amended permanently effective June 28, 1999 (26:13 Md. R. 1020)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended as an emergency provision effective June 26, 2000 (27:15 Md. R. 1397); amended permanently effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended as an emergency provision effective December 6, 2000 (28:3 Md. R. 203); amended permanently effective April 30, 2001 (28:8 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended effective October 29, 2001 (28:21 Md. R. 1856); May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A repealed effective September 1, 2003 (30:17 Md. R. 1203)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A amended effective November 15, 2010 (37:23 Md. R. 1611); August 6, 2012 (39:15 Md. R. 963); May 6, 2019 (46:9 Md. R. 445); April 5, 2021 (48:7 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A-2 amended effective December 10, 2012 (39:24 Md. R. 1577); April 5, 2021 (48:7 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26A-3 adopted effective April 5, 2021 (48:7 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26B amended effective October 3, 1988 (15:20 Md. R. 2334); May 29, 1989 (16:10 Md. R. 1109); May 14, 1990 (17:9 Md. R. 1092); August 1, 1994 (21:15 Md. R. 1306); March 11, 1996 (23:5 Md. R. 380); September 30, 2002 (29:19 Md. R. 1524); April 10, 2006 (33:7 Md. R. 673); April 5, 2010 (37:7 Md. R. 572); August 4, 2014 (41:15 Md. R. 891)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26C adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 677); emergency status expired July 22, 1998; adopted permanently effective September 7, 1998 (25:18 Md. R. 1435)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 adopted effective May 12, 2003 (30:9 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1244); amended permanently effective October 6, 2008 (35:20 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1B amended as an emergency provision effective March 21, 2014 (41:8 Md. R. 468); emergency status extended to August 1, 2014 (41:15 Md. R. 888); amended permanently effective July 7, 2014 (41:13 Md. R. 753)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 amended as an emergency provision effective July 1, 2015 (42:16 Md. R. 1053); amended permanently effective November 9, 2015 (42:22 Md. R. 1378)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-2 adopted effective March 9, 2009 (36:5 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective February 18, 2002 (29:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .100 recodified as Regulation .33</annotation> <annotation type="History" subtype="Administrative History">Regulation .34 adopted effective August 1, 1987 (14:15 Md. R. 1660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .35 adopted effective August 1, 1987 (14:15 Md. R. 1660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .36 adopted effective August 1, 1987 (14:15 Md. R. 1660)</annotation> </annotations> </chapter> <chapter num="11" heading="Rules of Procedure: Related Institutions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <text>“Commission” means the Health Services Cost Review Commission created by Chapter 627, Sec. 1, 1971 Laws of Maryland, and Health-General Article, § 19-202, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Report of Current and Prospective Charges."> <paragraph num="A."> <text>All related institutions shall immediately submit to the Commission a list of their current charges to patients.</text> </paragraph> <paragraph num="B."> <text>All related institutions shall immediately submit to the Commission their current interim Medicaid per diem rate, if any, and any supplementary charges to Medicaid patients. All changes shall be reported promptly to the Commission until the institution's Medicaid per diem rate is approved by the Commission. Final per diem rates shall be filed with the Commission during regular business hours.</text> </paragraph> <paragraph num="C."> <text>All information filed pursuant to Sec. A and B, above shall be open to public inspection and shall be available for examination at the offices of the Commission during regular business hours.</text> </paragraph> <paragraph num="D."> <text>Increases in the charges to be applied to non-Medicaid patients to be admitted to the related institution shall be submitted to the Commission at least 30 days before their implementation. All information filed pursuant to this section shall be open to public inspection and shall be available for examination at the offices of the Commission during regular business hours.</text> </paragraph> <paragraph num="E."> <text>Beginning with the second year of the Commission rate-approval for Medicaid, increases in the charges to be applied to patients who have already been admitted to a related institution may not exceed the allowed percentage increase of Medicaid rates in that institution without Commission approval.</text> </paragraph> <paragraph num="F."> <text>Before the second year of Commission rate-approval for Medicaid, the rate of increase by related institutions may not exceed the Commission approved general inflation increase for Medicaid patients without Commission approval. The approved inflation increase in the Medicaid rate shall accumulate and may be adjusted by the Commission for cost changes unique to an individual related institution.</text> </paragraph> <paragraph num="G."> <text>Patients Once Admitted.</text> <paragraph num="(1)"> <text>All charges to patients who have once been admitted to a related institution are subject to Sec. E and F, above.</text> </paragraph> <paragraph num="(2)"> <text>Patients “once admitted” include:</text> <paragraph num="(a)"> <text>Patients going from a related institution to a hospital and back to the related institution;</text> </paragraph> <paragraph num="(b)"> <text>Patients leaving a related institution temporarily on a physician-approved leave and then returning to the related institution;</text> </paragraph> <paragraph num="(c)"> <text>Anyone readmitted to the same institution within a 2-week time period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Patients who are for valid medical reasons transferred to a different level of care within a related institution may not be charged prospectively more than that which they could be charged if originally admitted to that new level.</text> </paragraph> <paragraph num="I."> <text>Sections E--H shall be effective only if Medicaid is paying Commission-approved rates in any related institution.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, § 19-219, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 11, 1977 (4:10 Md. R. 768)</annotation> </annotations> </chapter> <chapter num="12" heading="Cross-Subsidization"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Cross-subsidization” means the practice of charging a purchaser or class of purchaser more than the cost of care for a service with the result that another purchaser or class of purchaser is charged less than the cost of care for the same service.</text> </paragraph> <paragraph num="(2)"> <text>“Discount” means a reduction to Commission-approved rates.</text> </paragraph> <paragraph num="(3)"> <text>“Fixed-price contract” means an agreement or contract, written or oral, that sets forth a preestablished price for the provision of hospital services, or for the provision of hospital services in combination with physician or other services, that differs from Commission-approved rates.</text> </paragraph> <paragraph num="(4)"> <text>Related Entity.</text> <paragraph num="(a)"> <text>“Related entity” means an entity that is entering into at-risk arrangements for hospital-provided services and which is either subject to the exercise of control or significant influence by the management or operating policies of a hospital or exercises control over the management or operating policies of a hospital. In either event, one of the entities is, or may be, prevented from fully pursuing its own separate interests by virtue of its relationship with the other entity.</text> </paragraph> <paragraph num="(b)"> <text>Examples of “related entity” transactions include transactions between:</text> <paragraph num="(i)"> <text>A parent and its subsidiaries;</text> </paragraph> <paragraph num="(ii)"> <text>Subsidiaries of a common parent;</text> </paragraph> <paragraph num="(iii)"> <text>An entity and trusts for the benefit of employees that are managed by or under the trusteeship of the entities' management;</text> </paragraph> <paragraph num="(iv)"> <text>An entity and its principal owners, management, or members of their immediate families;</text> </paragraph> <paragraph num="(v)"> <text>Affiliates (an entity that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control of another entity);</text> </paragraph> <paragraph num="(vi)"> <text>An entity and a joint venture whose participants include the entity or a related entity; and</text> </paragraph> <paragraph num="(vii)"> <text>Two entities, both of which are related, directly or indirectly, to a common entity.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Hospital Charges to Purchasers or Classes of Purchasers."> <paragraph num="A."> <text>In order to assure purchasers of health care hospital services that rates are set equitably among all purchasers of services without undue discrimination, a hospital may not intentionally or otherwise engage in cross-subsidization without approval by the Commission. A hospital may grant a discount only as provided for in COMAR 10.37.10.26.</text> </paragraph> <paragraph num="B."> <text>Without the prior approval of the Commission, neither a hospital, a related entity, nor any entity or person acting on behalf of or in concert with a hospital shall enter into a fixed-price contract, or knowingly participate in or receive the benefit of any arrangement, directly or indirectly, pertaining to the delivery of hospital services. A hospital that has knowledge of such an arrangement shall promptly notify the Commission in accordance with this section in order that the Commission may determine whether the arrangement constitutes an unapproved discount. In order to obtain prior approval of the Commission, the hospital shall file a written application in accordance with COMAR 10.37.10.06. The filing of this application constitutes the filing of a required report under Commission law and regulation. Failure to file an application before the date on which a fixed-price contract is entered into, or the hospital or related entity knowingly participates in or receives benefit of such an arrangement, may subject the organization or organizations to fines up to $1,000 per day for each day the arrangement exists without prior approval.</text> </paragraph> <paragraph num="C."> <text>Factors to Consider When Reviewing a Proposed Arrangement.</text> <paragraph num="(1)"> <text>In reviewing a proposed arrangement under this regulation, the Commission shall consider the following factors:</text> <paragraph num="(a)"> <text>Whether the hospital is charging Commission-approved rates and whether payment for hospital services provided is made on the basis of Commission-approved rates;</text> </paragraph> <paragraph num="(b)"> <text>Whether any proposed deviation from Commission-approved rates is cost justified and does not result in any form of cross-subsidization;</text> </paragraph> <paragraph num="(c)"> <text>Whether payment at Commission-approved rates is made by an entity not related to the hospital;</text> </paragraph> <paragraph num="(d)"> <text>The term of the agreement and the termination provisions;</text> </paragraph> <paragraph num="(e)"> <text>The items or services to be furnished under the proposed agreement, including but not limited to hospital services, and the methodology for computing the payment for these services; and</text> </paragraph> <paragraph num="(f)"> <text>The proposed sources of funding for the arrangement, including the source of funds to cover any anticipated or unexpected losses under the arrangement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An agreement may not be reviewed for reasonableness unless the agreement is reduced to writing and specifies in advance the items or services to be furnished as well as the fixed price or methodology used to compute payment.</text> </paragraph> <paragraph num="(3)"> <text>The risk of substantial loss associated with any arrangement may not be borne by the hospital, either directly or indirectly.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For a period beginning with the effective date of this regulation and for a period of 6 months after that, the Commission shall offer an amnesty period. Any hospital which brings to the Commission's attention within the 6-month amnesty period any arrangement to which it is, directly or indirectly, a party shall have any price or compliance penalties which might otherwise have been imposed against it in connection with the arrangement, as set forth in Regulation .03 of this chapter, waived. The waiver shall expire at the later of the end of the 6-month amnesty period or the consideration of the Commission of the approval of the arrangement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <paragraph num="A."> <text>The Commission may impose penalties of up to $1,000 per day, which shall be instead of the $100 per day penalty for failing to file reports as set forth in COMAR 10.37.01.03N, for a required report submitted by a hospital that includes information which has the effect of violating Regulation .02 of this chapter. The report shall be considered substantially inaccurate and untimely filed.</text> </paragraph> <paragraph num="B."> <text>A hospital that violates the provisions of Regulation .02 of this chapter shall, in addition to any penalties imposed under §A of this regulation, be subject to the overcharge and undercharge penalties contained in COMAR 10.37.03.05, which shall be applied to the difference between what was actually charged by the hospital and what the hospital would have been required to charge under a valid Commission rate order based on accurate information filed. In addition, the Commission may revoke any discount previously granted under COMAR 10.37.10.26 to a third party that participates in an arrangement determined by the Commission to constitute an unapproved discount or otherwise violates the provisions of Regulation .02 of this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-207, 19-210, 19-212, and 19-216, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 1983 (9:26 Md. R. 2572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulations .01 — .03 adopted effective</annotation> <annotation type="History" subtype="Administrative History">February 17, 1992 (19:3 Md. R. 305)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 7, 1993 (20:11 Md. R. 913); December 2, 1996 (23:24 Md. R. 1683)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 7, 1993 (20:11 Md. R. 913); December 2, 1996 (23:24 Md. R. 1683)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 10, 1997 (24:5 Md. R. 412); July 28, 1997 (24:15 Md. R. 1062); March 4, 2013 (40:4 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 4, 2013 (40:4 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 7, 1993 (20:11 Md. R. 913)</annotation> </annotations> </chapter> <chapter num="13" heading="Patient Rights and Obligations; Hospital Credit and Collection and Financial Assistance Policies"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Credit and collection policy” means a hospital’s policy on the collection of medical debt.</text> </paragraph> <paragraph num="(2)"> <text>Debt Collector.</text> <paragraph num="(a)"> <text>“Debt collector” means a person who engages directly or indirectly in the business of:</text> <paragraph num="(i)"> <text>Collecting for, or soliciting from another, medical debt;</text> </paragraph> <paragraph num="(ii)"> <text>Giving, selling, attempting to give or sell to another, or using, for collection of medical debt, a series or system of forms or letters that indicates directly or indirectly that a person other than the hospital is asserting the medical debt; or</text> </paragraph> <paragraph num="(iii)"> <text>Employing the services of an individual or business to solicit or sell a collection system to be used for collection of medical debt.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Debt collector” includes a “collection agency” as defined in Business Regulation Article, §7-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Financial hardship” means medical debt, incurred by a family over a 12-month period, that exceeds 25 percent of family income.</text> </paragraph> <paragraph num="(4)"> <text>“Hospital” has the meaning stated in Health-General Article, §19- 301(f), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>Hospital Services.</text> <paragraph num="(a)"> <text>“Hospital services” means:</text> <paragraph num="(i)"> <text>Inpatient hospital services as enumerated in 42 C.F.R. §409.10, as amended;</text> </paragraph> <paragraph num="(ii)"> <text>Emergency services, including services provided at a freestanding medical facility licensed under Health Occupations Article, Title 19, Subtitle 3A, Annotated Code of Maryland</text> </paragraph> <paragraph num="(iii)"> <text>Outpatient services provided at a hospital as defined in COMAR 10.37.10.07-2;</text> </paragraph> <paragraph num="(iv)"> <text>Outpatient services, as specified by the Commission in COMAR 10.37.10.07-2, provided at a freestanding medical facility licensed under Health-General Article, Title 19, Subtitle 3A, Health-General Article, Annotated Code of Maryland that has received a certificate of need under Health-General Article, §19–120(o)(1), Annotated Code of Maryland, or an exemption from obtaining a certificate of need under Health-General Article, §19–120(o)(3), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(v)"> <text>Identified physician services for which a facility has Commission–approved rates on June 30, 1985.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Hospital services” includes a hospital outpatient service:</text> <paragraph num="(i)"> <text>Of a hospital that, on or before June 1, 2015, is under a merged asset hospital system;</text> </paragraph> <paragraph num="(ii)"> <text>That is designated as a part of another hospital under the same merged asset hospital system to make it possible for the hospital outpatient service to participate in the 340B Program under the federal Public Health Service Act; and</text> </paragraph> <paragraph num="(iii)"> <text>That complies with all federal requirements for the 340B Program and applicable provisions of 42 C.F.R. §413.65.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Hospital services” does not include:</text> <paragraph num="(i)"> <text>Outpatient renal dialysis services;</text> </paragraph> <paragraph num="(ii)"> <text>Outpatient services provided at a limited service hospital as defined in Health-General Article, §19–301, Annotated Code of Maryland except for emergency services; or</text> </paragraph> <paragraph num="(iii)"> <text>Physician services that are billed separately.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Household.</text> <paragraph num="(a)"> <text>“Household” means, at a minimum, for an adult patient, the patient and the following individuals that live in the same dwelling:</text> <paragraph num="(i)"> <text>A spouse, regardless of whether the patient and spouse expect to file a joint federal or State tax return;</text> </paragraph> <paragraph num="(ii)"> <text>Biological children, adopted children, or stepchildren; and</text> </paragraph> <paragraph num="(iii)"> <text>All individuals on the same federal or State tax return, including anyone for whom the patient claims a personal exemption in a federal or State tax return.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Household” means, at a minimum, for a patient who is a child, the patient and the following individuals that live in the same dwelling:</text> <paragraph num="(i)"> <text>Biological parents, adoptive parents, stepparents, or guardians;</text> </paragraph> <paragraph num="(ii)"> <text>Biological siblings, adopted siblings, or step siblings; and</text> </paragraph> <paragraph num="(iii)"> <text>All individuals on the same federal or State tax return, including anyone for whom the patient’s parents or guardians claim a personal exemption in a federal or State tax return.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The terms "household” and “family” are synonymous for the purposes of this chapter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Income.</text> <paragraph num="(a)"> <text>“Income” means total taxable income, before taxes.</text> </paragraph> <paragraph num="(b)"> <text>“Income” includes:</text> <paragraph num="(i)"> <text>If a hospital uses state or federal tax returns to verify income, the adjustments listed on Schedule 1 of Form 1040; and</text> </paragraph> <paragraph num="(ii)"> <text>If a hospital utilizes an asset test, the value of household monetary assets, consistent with Regulation 06J of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Initial bill” means the first billing statement provided to an individual by a hospital after the care, whether inpatient or outpatient, is provided and the individual has left the hospital.</text> </paragraph> <paragraph num="(9)"> <text>“Medical debt” means out-of-pocket expenses, including co-payments, coinsurance, and deductibles, for hospital services that are regulated by the Commission that are billed to a patient or a co-signer for the patient, excluding amounts contractually paid by another payer such as insurers, including Medicare, Medicaid, or CHIP.</text> </paragraph> <paragraph num="(10)"> <text>“Medically necessary care” including care provided in accordance with the Emergency Medical Treatment and Labor Act of 1986), means care that is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice; and</text> </paragraph> <paragraph num="(c)"> <text>Not primarily for the convenience of the patient, the patient’s family, or the provider.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Monetary Assets.</text> <paragraph num="(a)"> <text>“Monetary assets” means assets in excess of $100,000 that can readily be converted into a fixed or precisely determinable amount of money, including cash and cash equivalents.</text> </paragraph> <paragraph num="(b)"> <text>“Monetary assets” include cash on hand, bank deposits, investment accounts, accounts receivable, and notes receivable.</text> </paragraph> <paragraph num="(c)"> <text>“Monetary assets” do not include retirement assets to which the Internal Revenue Service has granted preferential tax treatment, including deferred–compensation plans qualified under the Internal Revenue Code or nonqualified deferred–compensation plans.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Payment Plan.</text> <paragraph num="(a)"> <text>“Payment plan” means an agreement between a patient, or a guarantor, to pay for a hospital service over a period of time.</text> </paragraph> <paragraph num="(b)"> <text>“Payment plan” includes:</text> <paragraph num="(i)"> <text>An “income-based payment plan” set forth in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>A “non-income-based payment plan” set forth in Regulation .05W of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Qualified Maryland resident” means someone who lives in Maryland for more than 6 months of the year or whose primary residence is in Maryland, including those in Maryland for school or work.</text> </paragraph> <paragraph num="(14)"> <text>Written.</text> <paragraph num="(a)"> <text>“Written” means communications in paper form and communications delivered electronically, including through electronic mail, a secure web, or mobile based application such as a patient portal.</text> </paragraph> <paragraph num="(b)"> <text>“Written” does not include oral communications, including communications delivered by phone.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Electronic Delivery of Written Communications."> <paragraph num="A."> <text>A patient may opt out of receiving written communications required by Regulations .03—.08 of this chapter through electronic delivery methods, such as through email or a patient portal.</text> </paragraph> <paragraph num="B."> <text>A hospital or debt collector who communicates with a patient electronically must include in such communication, or attempt to communicate, a clear and conspicuous statement describing a reasonable and simple method by which the patient can opt out of further electronic communications by the hospital or debt collector.</text> </paragraph> <paragraph num="C."> <text>A hospital or debt collector may not require, directly or indirectly, that the patient, in order to opt out of electronic communication, pay any fee or provide any information other than:</text> <paragraph num="(1)"> <text>The patient’s opt out preferences; and</text> </paragraph> <paragraph num="(2)"> <text>The email address, telephone number for text messages, or other electronic-medium address subject to the opt-out request.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a hospital or debt collector receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, the hospital or the debt collector:</text> <paragraph num="(1)"> <text>May not provide the written communications required by Regulations .03—.08 of this chapter through electronic delivery methods; and</text> </paragraph> <paragraph num="(2)"> <text>Shall deliver the written communications through non-electronic delivery methods.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice of Patient Opting Out of Written Communications.</text> <paragraph num="(1)"> <text>If a hospital receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, and the hospital uses a debt collector with respect to that patient, the hospital shall immediately inform the debt collector that the patient is opting out of electronic delivery methods.</text> </paragraph> <paragraph num="(2)"> <text>If a debt collector receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, the debt collector shall immediately inform the hospital that controls that patient account that the patient is opting out of electronic delivery methods.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Hospital Information Sheet."> <paragraph num="A."> <text>Each hospital shall develop an information sheet that:</text> <paragraph num="(1)"> <text>Describes clearly:</text> <paragraph num="(a)"> <text>The hospital's financial assistance policy as required in Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>A patient's legal rights and obligations with regard to hospital billing and collection;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Informs the patient, the patient’s family, the patient’s authorized representative, or the patient’s legal guardian:</text> <paragraph num="(a)"> <text>That the hospital is permitted to bill outpatients a fee, commonly referred to as a facility fee, for their use of hospital facilities, clinics, supplies, and equipment, and nonphysician services, including but not limited to the services of nonphysician clinicians, in addition to physician fees billed for professional services provided in the hospital;</text> </paragraph> <paragraph num="(b)"> <text>Of the patient’s right to request and receive a written estimate of the total charges for the hospital non-emergency services, procedures, and supplies that reasonably are expected to be provided and billed for by the hospital, in addition to the good faith estimate requirements in 42 U.S.C §2799B-6, the No Surprises Act;</text> </paragraph> <paragraph num="(c)"> <text>Of the patient’s right to file a complaint with the Commission or jointly with the Health Education and Advocacy Unit of the Maryland Attorney General’s Office against a hospital for an alleged violation of Health-General Article, §§19-214.1 and 19-214.2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>Of the availability of an income-based payment plan; and</text> </paragraph> <paragraph num="(e)"> <text>That physician charges, to both hospital inpatients and outpatients, are generally not included in the hospital bill and are billed separately;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provides contact information for:</text> <paragraph num="(a)"> <text>The individual or office at the hospital that is available to assist the patient, the patient's family, or the patient's authorized representative in order to understand:</text> <paragraph num="(i)"> <text>The patient's hospital bill;</text> </paragraph> <paragraph num="(ii)"> <text>The patient’s rights and obligations with regard to the hospital bill, including the patient’s rights and obligations with regard to reduced-cost medically necessary care due to a financial hardship;</text> </paragraph> <paragraph num="(iii)"> <text>How to apply for financial assistance;</text> </paragraph> <paragraph num="(iv)"> <text>How to apply for the Maryland Medical Assistance Program and any other programs that may help pay the bill; and</text> </paragraph> <paragraph num="(v)"> <text>How to apply for a payment plan;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Maryland Medical Assistance Program;</text> </paragraph> <paragraph num="(c)"> <text>Filing a complaint with the Commission or jointly with the Health Education and Advocacy Unit of the Maryland Attorney General’s Office against a hospital for an alleged violation of Health-General Article, §§19-214.1 and 19-214.2, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Includes a section that allows the patient to initial that the patient has been made aware of the financial assistance policy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The information sheet shall be written in:</text> <paragraph num="(1)"> <text>Simplified language;</text> </paragraph> <paragraph num="(2)"> <text>At least 12-point type; and</text> </paragraph> <paragraph num="(3)"> <text>The patient’s preferred language or, if no preferred language is specified, each language spoken by a limited English proficient population that constitutes at least 5 percent of the overall population within the city or county in which the hospital is located as measured by the most recent census.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The information sheet shall conform with Health-General Article, §19–342(d)(7) and (10), Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The information sheet shall be provided in writing to the patient, the patient’s family, the patient’s authorized representative, or the patient’s legal guardian:</text> <paragraph num="(1)"> <text>Before the patient receives scheduled medical services;</text> </paragraph> <paragraph num="(2)"> <text>Before discharge;</text> </paragraph> <paragraph num="(3)"> <text>With the hospital bill;</text> </paragraph> <paragraph num="(4)"> <text>On request; and</text> </paragraph> <paragraph num="(5)"> <text>In each written communication to the patient regarding collection of the hospital bill.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital bill shall include a reference to the information sheet.</text> </paragraph> <paragraph num="F."> <text>The Commission shall:</text> <paragraph num="(1)"> <text>Establish uniform requirements for the information sheet; and</text> </paragraph> <paragraph num="(2)"> <text>Review each hospital's implementation of and compliance with the requirements of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Hospital Credit and Collection Responsibilities."> <paragraph num="A."> <text>Each hospital shall submit to the Commission, at times prescribed by the Commission, the hospital's credit and collection policy.</text> </paragraph> <paragraph num="B."> <text>The policy shall:</text> <paragraph num="(1)"> <text>Provide for active oversight by the hospital of any contract for collection of debts on behalf of the hospital;</text> </paragraph> <paragraph num="(2)"> <text>Prohibit the hospital from selling any debt, except as permitted by Health-General Article, §19–214.2(m), Annotated Code of Maryland and §O of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Prohibit the hospital from:</text> <paragraph num="(a)"> <text>Engaging in collection activities on 100 percent of the outstanding amount of the Commission-set charge for debt sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Collecting on judgments entered into on patient debt that was sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Reporting adverse information to a consumer reporting agency;</text> </paragraph> <paragraph num="(d)"> <text>Filing a civil action to collect a debt against a patient within 240 days after the initial bill is provided;</text> </paragraph> <paragraph num="(e)"> <text>Filing a civil action to collect a debt against a patient whose outstanding hospital medical debt is at or below $500;</text> </paragraph> <paragraph num="(f)"> <text>Forcing the sale or foreclosure of a patient’s primary residence to collect medical debt;</text> </paragraph> <paragraph num="(g)"> <text>Requesting a lien against a patient’s primary residence in an action to collect medical debt;</text> </paragraph> <paragraph num="(h)"> <text>Requesting the issuance of or otherwise knowingly taking action that would cause a court to issue a body attachment against a patient or an arrest warrant against a patient, if the hospital files an action to collect medical debt; and</text> </paragraph> <paragraph num="(i)"> <text>Requesting a writ of garnishment of wages or filing an action that would result in an attachment of wages against a patient to collect medical debt if the patient is eligible for free or reduced-cost medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>In accordance with Health-General Article, §19-214.2(c), Annotated Code of Maryland and §G of this regulation, provide for a refund of amounts collected from a patient or the guarantor of a patient who was later found to be eligible for free medically necessary care within 240 days after the initial bill was provided under Health General Article, §19-214.1, Annotated Code of Maryland and §G of this regulation;</text> </paragraph> <paragraph num="(5)"> <text>If the hospital has obtained a judgment against or had reported adverse information to a consumer reporting agency about a patient who later was found to be eligible for free medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland, within 240 days after the initial bill was provided, require the hospital to seek to vacate the judgment or strike the adverse information;</text> </paragraph> <paragraph num="(6)"> <text>Provide a mechanism for a patient to:</text> <paragraph num="(a)"> <text>Request the hospital to reconsider the denial of free or reduced–cost care; and</text> </paragraph> <paragraph num="(b)"> <text>File with the hospital a complaint against the hospital or a debt collector used by the hospital regarding the handling of the patient’s bill;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>For a patient who is eligible for free or reduced cost-care under the hospital’s financial assistance policy, prohibit the hospital from:</text> <paragraph num="(a)"> <text>Charging interest on the debt owed on a bill for the patient before a court judgement is obtained; or</text> </paragraph> <paragraph num="(b)"> <text>Collecting fees or any other amount that exceeds the approved charge for the hospital service as established by the Commission;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Establish a process for making payment plans available to all patients in accordance with Regulation .05 of this chapter and Health-General Article, §19-214.2(e)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Provide detailed procedures for the following actions:</text> <paragraph num="(a)"> <text>When garnishments may be applied to a patient’s or patient guarantor’s income in accordance with §I of this regulation and Health-General Article, §19-214.2(f)(4), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>When a lien on a patient’s or patient guarantor’s personal residence, excluding a primary resident in accordance with §I of this regulation and Health-General Article, §19-214.2(g)(2), Annotated Code of Maryland, or motor vehicle may be placed;</text> </paragraph> <paragraph num="(c)"> <text>The hospital's procedures for collecting any medical debt, consistent this regulation;</text> </paragraph> <paragraph num="(d)"> <text>The circumstances in which the hospital will seek a judgment against a patient for the patient’s medical debt, subject to §I of this regulation and Health-General Article, §19–214.2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>The consideration by the hospital of patient income, assets, and other criteria set forth in this regulation; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Comply with Health-General Article, §24-2502, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Consistent with Health-General Article, §19-214.2(e)(5), Annotated Code of Maryland, a hospital shall demonstrate that it attempted in good faith to meet the requirements of Health-General Article, §19-214.2(e), Annotated Code of Maryland, and the Guidelines set forth in Regulation .05 of this chapter before the hospital:</text> <paragraph num="(1)"> <text>Files an action to collect the patient’s medical debt; or</text> </paragraph> <paragraph num="(2)"> <text>Delegates collection activity to a debt collector for a patient’s medical debt.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospital shall be deemed to have demonstrated that it attempted to act in good faith under Health-General Article, §19-214.2(e)(5)(i)(2), Annotated Code of Maryland and §C(2) of this regulation if, before delegating collection of a patient’s medical debt to a debt collector, the hospital:</text> <paragraph num="(1)"> <text>Provides the information sheet before the patient receives scheduled medical services and before discharge in accordance with Health-General Article, §19-214.2(e)(1) and (2), Annotated Code of Maryland, and in Regulation .03D(1) and (2) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Establishes a process for making payment plans available to all patients in accordance with Health-General Article, §19-214.2(e)(3), Annotated Code of Maryland and Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In delegating any or all collection to a debt collector for a patient’s medical debt, the hospital may rely on a debt collector to engage in various activities, including:</text> <paragraph num="(1)"> <text>Facilitating and servicing payment plans in accordance with the Guidelines, including receiving and forwarding any payments received under a payment plan approved by the hospital; and</text> </paragraph> <paragraph num="(2)"> <text>Such other activities as the hospital may direct in collecting and forwarding payments under a payment plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A hospital may not seek legal action to collect a patient’s medical debt until the hospital has established and implemented a payment plan policy that complies with the Guidelines.</text> </paragraph> <paragraph num="G."> <text>As provided by Health-General Article, §19-214.2(c), Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>A hospital shall provide:</text> <paragraph num="(a)"> <text>For a refund of amounts exceeding $25 collected from a patient or the guarantor of a patient who was found to be eligible for free medically necessary care within 240 days after the initial bill is provided to the patient; and</text> </paragraph> <paragraph num="(b)"> <text>The refund to the patient not later than 30 days after determining that the patient was eligible for free medically necessary care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a patient is enrolled in a means-tested government health care plan that requires the patient to pay out-of-pocket for hospital service, a hospital shall have a refund policy that complies with the terms of the patient’s plan.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Consumer Reporting.</text> <paragraph num="(1)"> <text>A hospital may not commence civil action against a patient for nonpayment or delegate collection activity to a debt collector, if the hospital:</text> <paragraph num="(a)"> <text>Was notified in accordance with federal law by the patient or the insurance carrier that an appeal or a review of a health insurance decision is pending within the immediately preceding 60 days;</text> </paragraph> <paragraph num="(b)"> <text>Is processing a requested reconsideration of the denial of free or reduced-cost medically necessary care under Regulation .06A(1)(c)(v) of this chapter and Health-General Article, §19-214.1(b)(2)(iv), Annotated Code of Maryland, that was appropriately completed by the patient or has completed the reconsideration within the immediately preceding 60 days; or</text> </paragraph> <paragraph num="(c)"> <text>Sold the debt under §O of this regulation and Health-General Article, §19-214.2(m).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A hospital shall comply with Health-General Article, §24-2502, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>A hospital shall report the fulfillment of a patient’s payment obligation within 60 days after the obligation is fulfilled to any consumer reporting agency to which the hospital had reported adverse information about the patient, including if the debt was sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>Not later than November 1, 2025, a hospital that had reported adverse information about a patient to a consumer reporting agency shall instruct the consumer reporting agency to delete the adverse information about the patient.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Civil Action.</text> <paragraph num="(1)"> <text>Deceased Patients.</text> <paragraph num="(a)"> <text>A hospital may not make a claim against the estate of a deceased patient to collect medical debt if the deceased patient was known by the hospital to be eligible for free medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland, or if the value of the estate after tax obligations are fulfilled is less than half of the medical debt owed.</text> </paragraph> <paragraph num="(b)"> <text>A hospital may offer the family of the deceased patient the ability to apply for financial assistance.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A hospital may not file an action to collect medical debt until the hospital determines whether the patient is eligible for free or reduced-cost medically necessary care under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>At least 45 days before filing an action against a patient to collect medical debt, but not within 240 days after the initial bill is provided, a hospital shall send written notice of the intent to file an action to the patient.</text> </paragraph> <paragraph num="(4)"> <text>The notice required in §I(3) of this regulation shall:</text> <paragraph num="(a)"> <text>Be sent to the patient by certified mail and first class mail;</text> </paragraph> <paragraph num="(b)"> <text>Be in simplified language;</text> </paragraph> <paragraph num="(c)"> <text>Be in at least 12-point type;</text> </paragraph> <paragraph num="(d)"> <text>Include:</text> <paragraph num="(i)"> <text>The name and telephone number of the hospital, the debt collector, if applicable, and an agent of the hospital authorized to modify the terms of the payment plan, if any;</text> </paragraph> <paragraph num="(ii)"> <text>The amount required to cure the nonpayment of medical debt, including past due payments, interest, penalties, and fees;</text> </paragraph> <paragraph num="(iii)"> <text>A statement recommending that the patient seek debt counseling services;</text> </paragraph> <paragraph num="(iv)"> <text>Telephone numbers and internet addresses of the Health Education Advocacy Unit of the Office of the Attorney General, available to assist patients experiencing medical debt; and</text> </paragraph> <paragraph num="(v)"> <text>An explanation of the hospital's financial assistance policy;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Be provided in the patient’s preferred language or, if no preferred language is specified, English and each language spoken by a limited English proficient population that constitutes at least 5 percent of the population within the jurisdiction in which the hospital is located as measured by the most recent federal census; and</text> </paragraph> <paragraph num="(f)"> <text>Be accompanied by:</text> <paragraph num="(i)"> <text>An application for financial assistance under the hospital's financial assistance policy, along with instructions for completing the application for financial assistance, specific instructions about where to send the application, and the telephone number to call to confirm receipt of the application;</text> </paragraph> <paragraph num="(ii)"> <text>Language explaining the availability of an income-based payment plan to satisfy the medical debt that is the subject of the hospital debt collection action; and</text> </paragraph> <paragraph num="(iii)"> <text>The information sheet required under Regulation .03 of this chapter and Health-General Article, §19-214.1(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Delegation of Collection to a Debt Collector. If a hospital delegates collection activity to a debt collector, the hospital shall:</text> <paragraph num="(1)"> <text>Specify the collection activity to be performed by the debt collector through an explicit authorization or contract;</text> </paragraph> <paragraph num="(2)"> <text>Require the debt collector to abide by the hospital’s credit and collection policy;</text> </paragraph> <paragraph num="(3)"> <text>Specify procedures the debt collector must follow if a patient appears to qualify for financial assistance under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Require the debt collector to:</text> <paragraph num="(a)"> <text>In accordance with the hospital’s credit and collection policy, provide a mechanism for a patient to file with the hospital a complaint against the hospital or the debt collector regarding the handling of patient’s bill;</text> </paragraph> <paragraph num="(b)"> <text>If a patient files a complaint with the debt collector, forward the complaint to the hospital; and</text> </paragraph> <paragraph num="(c)"> <text>Along with the hospital, be jointly and severally responsible for meeting the requirements of this regulation, Regulation .06 of this chapter, and Health-General Article, §19-214.2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Consent to Assume Liability for Medical Debt.</text> <paragraph num="(1)"> <text>A spouse or another individual may not be held liable for the medical debt of an individual 18 years old or older unless the individual voluntarily consents to assume liability for the patient’s medical debt.</text> </paragraph> <paragraph num="(2)"> <text>The consent shall be:</text> <paragraph num="(a)"> <text>Made on a separate document signed by the individual;</text> </paragraph> <paragraph num="(b)"> <text>Not solicited in an emergency room or during an emergency situation; and</text> </paragraph> <paragraph num="(c)"> <text>Not required as a condition of providing emergency or non-emergency health care services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>The Board of Directors of each hospital shall review and approve the hospital’s financial assistance policy required under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland and debt collection policy required under Regulation .04 of this chapter and Health-General Article, §19-214.2, Annotated Code of Maryland at least every 2 years. A hospital may not alter its financial assistance or credit and collection policies without approval of the Board of Directors.</text> </paragraph> <paragraph num="M."> <text>The Commission shall review each hospital's implementation of and compliance with the hospital's policy and the requirements of §B of this regulation.</text> </paragraph> <paragraph num="N."> <text>Reporting Requirements.</text> <paragraph num="(1)"> <text>Each hospital shall annually submit to the Commission within 120 days after the end of each hospital’s fiscal year a report including:</text> <paragraph num="(a)"> <text>The total number of patients by race or ethnicity, gender, and zip code of residence against whom the hospital or a debt collector used by the hospital, filed an action to collect medical debt;</text> </paragraph> <paragraph num="(b)"> <text>The total number of patients by race or ethnicity, gender, and zip code of residence with respect to whom the hospital has and has not reported or classified a bad debt;</text> </paragraph> <paragraph num="(c)"> <text>The total dollar amount of charges for hospital services provided to patients but not collected by the hospital for patients covered by insurance, including the out-of-pocket costs for patients covered by insurance, and patients without insurance; and</text> </paragraph> <paragraph num="(d)"> <text>For hospital debts owed by patients of the hospital that the hospital sold to a governmental unit, contractor, or nonprofit organization under Health-General Article, §19-214.2(m), Annotated Code of Maryland and §O of this regulation:</text> <paragraph num="(i)"> <text>The total dollar amount of the debt sold by the hospital for the reporting year;</text> </paragraph> <paragraph num="(ii)"> <text>The total dollar amount paid by the hospital to the unit, contractor, or nonprofit organization who purchased the debt; and</text> </paragraph> <paragraph num="(iii)"> <text>The total number of patients whose debt was sold, in full or in part, to the unit, contractor, or nonprofit organization who purchased the debt.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Commission shall post the information submitted under §N(1) of this regulation on its website.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Selling Medical Debt.</text> <paragraph num="(1)"> <text>Consistent with Health-General Article, §19-214.2(m), Annotated Code of Maryland, a hospital may sell debt owed to the hospital by a patient for hospital services to a governmental unit, an entity that is under contract with the governmental unit, or to a nonprofit organization that is exempt from taxation under 26 U.S.C. §501(c)(3) of the Internal Revenue Code for the sole purpose of canceling the debt.</text> </paragraph> <paragraph num="(2)"> <text>The contract between the hospital and the governmental unit, entity that is under contract with the governmental unit, or nonprofit organization purchasing the debt shall state that the sole purpose of the sale of the debt is to cancel the debt.</text> </paragraph> <paragraph num="(3)"> <text>The patient is not responsible to the hospital, the governmental unit, the entity that is under contract with the governmental unit, or the nonprofit organization for any amount of the debt that is sold, or any interest, fees, or costs associated with the debt or the sale.</text> </paragraph> <paragraph num="(4)"> <text>Debt sold under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland:</text> <paragraph num="(a)"> <text>Must be for hospital services provided at least 2 years before the date of the sale;</text> </paragraph> <paragraph num="(b)"> <text>May not be expected to yield additional reimbursements from a third-party payor;</text> </paragraph> <paragraph num="(c)"> <text>May not be subject to an open appeal with an insurance company; and</text> </paragraph> <paragraph num="(d)"> <text>Must be for an individual whose family income is at or below 500 percent of the federal poverty level or who has medical debt exceeding 5 percent of the patient’s family income, as determined by the governmental unit, contractor, or nonprofit organization purchasing the debt.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Debt sold under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland, may be sold with a reduction of Commission charges.</text> </paragraph> <paragraph num="(6)"> <text>The Commission shall treat the amount of payments to hospitals under this subsection as an offset to uncompensated care amounts reported by hospitals.</text> </paragraph> <paragraph num="(7)"> <text>The purchaser of the debt shall:</text> <paragraph num="(a)"> <text>Notify the patient that the debt has been canceled; and</text> </paragraph> <paragraph num="(b)"> <text>If the hospital obtained a judgment against the patient or reported adverse information to a consumer reporting agency about the patient, seek to vacate the judgment or strike the adverse information.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>If a hospital sells hospital medical debt under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland, the hospital must immediately dismiss actions pending against a patient for collection of that debt.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Guidelines for Hospital Payment Plans."> <paragraph num="A."> <text>Scope.</text> <paragraph num="(1)"> <text>As described in this regulation, the Guidelines for Hospital Payment Plans apply to any income-based payment plan offered by a hospital to a patient to pay for medically necessary hospital services after the services are provided.</text> </paragraph> <paragraph num="(2)"> <text>“Income” in this regulation means household monthly income.</text> </paragraph> <paragraph num="(3)"> <text>Prepayment Plans. Nothing in the Guidelines prevents a hospital from offering patients arrangements to make payments prior to service, provided that:</text> <paragraph num="(a)"> <text>A hospital may not require or steer a patient to enter into such an arrangement solely to avoid the application of these Guidelines;</text> </paragraph> <paragraph num="(b)"> <text>Before a hospital requests pre-payment for a hospital service, the hospital shall:</text> <paragraph num="(i)"> <text>Comply with the notice provisions of Health-General Article, §19-214.1, Annotated Code of Maryland, and Regulations .03 and .06 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Advise the patient about the availability of financial assistance;</text> </paragraph> <paragraph num="(iii)"> <text>Process any request for financial assistance; and</text> </paragraph> <paragraph num="(iv)"> <text>Advise the patient about the availability of income-based payment plans, including information about the 5 percent cap on monthly payment amounts under §F(1) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Such an arrangement terminates once the hospital service is rendered.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Unregulated Services. These Guidelines apply only to hospital services that are regulated by the Commission. These Guidelines do not apply to services that are not regulated by the Commission, including physician services.</text> </paragraph> <paragraph num="(5)"> <text>Limitation of the Guidelines. These Guidelines do not prevent hospitals from extending payment plans for services, such as physician services, or at times that are outside the parameters of the Guidelines. Except as otherwise required by law or regulation, payment plans that are outside the parameters of these Guidelines are not subject to the Guidelines.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Access to Income-Based Payment Plans.</text> <paragraph num="(1)"> <text>Availability of Income-Based Payment Plans. Maryland hospitals shall make income-based payment plans available to all patients who are Maryland residents, including individuals temporarily residing in Maryland due to work or school, irrespective of their:</text> <paragraph num="(a)"> <text>Insurance status;</text> </paragraph> <paragraph num="(b)"> <text>Citizenship status;</text> </paragraph> <paragraph num="(c)"> <text>Immigration status; or</text> </paragraph> <paragraph num="(d)"> <text>Eligibility for reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, under Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Treatment of Nonresidents and Unregulated Services.</text> <paragraph num="(a)"> <text>These Guidelines do not prevent a hospital from extending payment plans to patients who are not described in §B(1) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>These Guidelines do not prevent a hospital from extending payment plans to patients for services that are not regulated by the Commission.</text> </paragraph> <paragraph num="(c)"> <text>Except as required by §U of this regulation or by other law or regulation, payment plans for patients which are not described in §B(1) of this regulation and payment plans for services that are not regulated by the Commission are not subject to the Guidelines under this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Notice Requirements.</text> <paragraph num="(1)"> <text>Notice of Availability of an Income-Based Payment Plan.</text> <paragraph num="(a)"> <text>Posted Notice.</text> <paragraph num="(i)"> <text>A notice shall be posted in conspicuous places throughout the hospital, including the billing office, informing Maryland residents of the availability of an income-based payment plan and whom to contact at the hospital for additional information.</text> </paragraph> <paragraph num="(ii)"> <text>If the hospital uses a vendor to assist with financial assistance eligibility, billing, or debt collection, such as a debt collector or eligibility vendor, the hospital shall ensure that the vendor posts a notice in a conspicuous place on their website or online payment portal, informing Maryland residents of the availability of an income-based payment plan and whom to contact at the hospital or debt collector for additional information. Placement on the website or online payment portal should be based on the best interest of the patient.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Information Sheet. A written notice of the availability of an income-based payment plan shall be contained in the information sheet required under Regulation .03 of this chapter, including clarity on the availability of income-based payment plans for Maryland residents, and, if payment plans for non-residents are included in the hospital’s credit and collection policy, the availability of such plans for non-residents.</text> </paragraph> <paragraph num="(c)"> <text>Before a Prepayment Plan. Before a patient enters into a prepayment plan as described in §A(2) of this regulation for a medically necessary hospital service, a hospital shall provide a written notice of the availability of an income-based payment plan to a patient.</text> </paragraph> <paragraph num="(d)"> <text>On a Bill. On the same page of the bill that includes the amount due and due date, the hospital shall provide notice that a lower monthly payment amount may be possible through an income-based plan, in the same font and style as the total amount due notification.</text> </paragraph> <paragraph num="(e)"> <text>Online Payment Portal. On both the page of the online payment portal that states the amount due, and where the consumer enters the amount being paid by the consumer, the hospital shall provide, in the same font and style as the amount due notification, notice informing Maryland residents of the availability of an income-based monthly payment plan and information, including a telephone number and email address, in order to contact the hospital for additional information.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notice of Terms Before Execution. A hospital shall provide written notice of the terms of an income-based payment plan to a patient before the patient agrees to enter the income-based payment plan. The terms of the income-based payment plan shall include:</text> <paragraph num="(a)"> <text>The amount of medical debt owed to the hospital;</text> </paragraph> <paragraph num="(b)"> <text>The interest rate applied to the income-based payment plan and the total amount of interest expected to be paid by the patient under the income-based payment plan;</text> </paragraph> <paragraph num="(c)"> <text>The amount of each periodic payment expected from the patient under the income-based payment plan;</text> </paragraph> <paragraph num="(d)"> <text>The number of periodic payments expected from the patient under the income-based payment plan;</text> </paragraph> <paragraph num="(e)"> <text>The expected due dates for each payment from the patient;</text> </paragraph> <paragraph num="(f)"> <text>The expected date by which the account will be paid off in full;</text> </paragraph> <paragraph num="(g)"> <text>The treatment of any missed payments, including missed payments and default as described in §P and T of this regulation;</text> </paragraph> <paragraph num="(h)"> <text>That there are no penalties for early payments; and</text> </paragraph> <paragraph num="(i)"> <text>Whether the hospital plans to apply a periodic recalculation of monthly payment amounts as described in §N of this regulation and the process for such recalculation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notice of Plan After Execution. A hospital shall promptly provide a written income-based payment plan, including items listed in §C(2) of this regulation, to the patient following execution by all parties. The income-based payment plan shall be provided to the patient at least 20 days before the due date of the patient’s first payment under the income-based payment plan.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Financial Assistance.</text> <paragraph num="(1)"> <text>Before entering into an income-based payment plan with a patient, hospitals shall evaluate if the patient is eligible for financial assistance, including free and reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, in accordance with Regulation .06 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Hospitals shall:</text> <paragraph num="(a)"> <text>Apply the financial assistance reduction before entering into an income-based payment plan with a patient; and</text> </paragraph> <paragraph num="(b)"> <text>Use any information collected for determining financial assistance under Regulation .06 of this chapter to establish the 5 percent monthly payment threshold for payment plans under Regulation .05F of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Offer Required. Hospitals must offer income-based payment plans that meet the requirements of these Guidelines.</text> </paragraph> <paragraph num="F."> <text>Monthly Payment Amounts.</text> <paragraph num="(1)"> <text>Under an income-based payment plan subject to these Guidelines, a hospital may not require a patient to make total payments in a month that exceed 5 percent of the lesser of the patient’s household income.</text> </paragraph> <paragraph num="(2)"> <text>§F(1) of this regulation applies to total amounts due under the plan, including both principal and interest, but does not apply to any catch-up payments, such as payments described under §P(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>A hospital shall calculate the monthly payment amount threshold under §F(1) of this regulation by dividing income level by household size and multiplying by .05 percent.</text> </paragraph> <paragraph num="(4)"> <text>Determining the Household Size.</text> <paragraph num="(a)"> <text>The hospital shall determine the size of the patient’s household using the number reported on tax returns, if provided the number of tax filers and dependents listed on the tax return provided by the patient. For example, if a married couple files jointly and has three dependents, the number of tax filers and dependents would equal five.</text> </paragraph> <paragraph num="(b)"> <text>If a patient files as an individual and the patient is not a dependent and has no dependents, the number of tax filers would equal one.</text> </paragraph> <paragraph num="(c)"> <text>If the patient has not provided a tax return, the hospital shall ask the patient to provide the number of individuals in the household.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Expenses. A hospital may reduce the amount of the monthly payment due under an income-based payment plan upon consideration of household expense information provided by a patient.</text> </paragraph> <paragraph num="H."> <text>Application to Multiple Income-based Payment Plans.</text> <paragraph num="(1)"> <text>Hospitals. A hospital shall ensure that the total monthly payment amount for all income-based payment plans provided to a patient by the hospital, when added up collectively, does not exceed the income limitation under §F(1) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Hospital System. A hospital system shall ensure that the total monthly payment amount for all income-based payment plans provided to a patient by all hospitals in the hospital system, when added up collectively, does not exceed the income limitation under §F(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Duration of Income-Based Payment Plan. The duration of an income-based payment plan, in months, is determined by the total amount owed, and interest, if interest applies, divided by the total amount of the payment due each month, subject to the limitation that no monthly payment may exceed 5 percent of the patient’s income as calculated under §F(1)of this regulation.</text> </paragraph> <paragraph num="J."> <text>Solicitation of Early Payments Prohibited. Hospitals may not solicit, steer, or mandate patients to pay an amount in excess of the monthly payment amount provided for in an income-based payment plan.</text> </paragraph> <paragraph num="K."> <text>Application of Partial Payments. A hospital shall apply partial payments in a manner most favorable to the patient.</text> </paragraph> <paragraph num="L."> <text>Interest and Fees.</text> <paragraph num="(1)"> <text>No Interest for Patients Eligible for Financial Assistance. For a patient who is eligible for free or reduced-cost medically necessary care under the hospital’s financial assistance policy under Regulation .06 of this chapter and Health-General Article, §19–214.1, Annotated Code of Maryland, the hospital may not charge interest or fees on any medical debt amount owed under an income-based payment plan.</text> </paragraph> <paragraph num="(2)"> <text>Allowable Interest. A hospital may charge interest under an income-based payment plan for a patient who is not eligible for free or reduced-cost medically necessary care, as described in §L of this regulation. A hospital is not required to charge interest for a payment plan.</text> </paragraph> <paragraph num="(3)"> <text>Interest Rate.</text> <paragraph num="(a)"> <text>An income-based payment plan may not provide for interest in excess of an effective rate of simple interest of 6 percent per annum on the unpaid principal balance of the payment plan.</text> </paragraph> <paragraph num="(b)"> <text>A hospital may not set an interest rate that results in negative amortization.</text> </paragraph> <paragraph num="(c)"> <text>Payers subject to Insurance Article, §15-1005, Annotated Code of Maryland, shall comply with its provisions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Timing. Interest may not begin before 240 days after the initial bill is provided.</text> </paragraph> <paragraph num="(5)"> <text>Late payments. A hospital may not charge additional fees or interest for late payments.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Early Payment.</text> <paragraph num="(1)"> <text>Prepayment Allowed.</text> <paragraph num="(a)"> <text>Patients may, on a voluntary basis, pre-pay, in whole or in part, any amounts owed under an income-based payment plan.</text> </paragraph> <paragraph num="(b)"> <text>Any prepayment made under §M(1) of this regulation is not subject to the monthly income payment limitations of §F(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>No Fees or Penalties. A hospital may not assess fees or otherwise penalize early payment of an income-based payment plan.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Limited Modifications of Income-based Payment Plans.</text> <paragraph num="(1)"> <text>Change in Income. If a patient with an income-based payment plan notifies a hospital that the patient’s income has changed, then the hospital shall offer to modify the income-based payment plan to meet the requirement of §N(6) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Expenses. Before modifying an income-based payment plan, a hospital shall consider information provided by a patient about changes in household expenses in considering a patient request to modify a payment plan.</text> </paragraph> <paragraph num="(3)"> <text>No Increase in Interest Rate. A hospital may not increase the interest rate on an income-based payment plan when making a modification to an income-based payment plan under this Guideline.</text> </paragraph> <paragraph num="(4)"> <text>Limitation on Payment Amount. A hospital may not modify an income-based payment plan in a way that requires a patient to make a monthly payment that exceeds the percent of the patient’s income used to set the monthly payment amount under the initial income-based payment plan as provided for in §F of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>Change in Duration. The duration of a modified income-based payment plan, in months, is determined by the total amount owed, and interest, if interest applies, divided by the total amount of the payment due each month, subject to the limitation under §F of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>Process for Modifying an Income-Based Payment Plan.</text> <paragraph num="(a)"> <text>Prompt Response to Patient Request. If a patient requests a modification to the terms of the payment plan, the hospital shall respond in a timely manner and may not refer the outstanding balance owed to a collection agency or for legal action until 30 days after providing a written response to the patient’s request for a modification of the payment plan.</text> </paragraph> <paragraph num="(b)"> <text>Reconsideration for Financial Assistance. If a patient makes a request for modification of a payment plan, the hospital shall consider if such patient is eligible for financial assistance, including free medically necessary care, reduced-cost medically necessary care, and reduced-cost care due to financial hardship under Regulation .06 of this chapter. The hospital will apply the financial assistance reduction in its modification of the payment plan.</text> </paragraph> <paragraph num="(c)"> <text>Mutual Agreement. A hospital may not modify a payment plan without mutual agreement between the hospital and the patient before the changes are made.</text> </paragraph> <paragraph num="(d)"> <text>Notice of Terms. The hospital shall provide the patient with a written notice of all payment plan terms, consistent with the requirements of §C of this regulation, upon modifying a payment plan under this Guideline.</text> </paragraph> </paragraph> </paragraph> <paragraph num="O."> <text>Hospital-Initiated Changes to Income-Based Payment Plans Based on Changes to Patient Income.</text> <paragraph num="(1)"> <text>Recalculation Allowed. A hospital may, in the terms of an initial income-based payment plan under §C(2) of this regulation that exceeds 3 years in length, provide for periodic recalculations to the amount of the monthly payments and the duration of the payment plan based on changes in the patient’s income as subject to and calculated under §N(5) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Notice Included in Initial Income-Based Payment Plan.</text> <paragraph num="(a)"> <text>The hospital may only recalculate payment amounts under an income-based payment plan if the hospital included the process for such recalculation in the notice provided to the patient before they entered into the income-based payment plan, in accordance with §C(2) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>The patient’s agreement to enter into the income-based payment plan after receiving that notice constitutes consent to the payment recalculations allowed under §P of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Limitations on Modification Apply. The provisions of §N of this regulation relating to limitations of payment plan modifications apply to payment recalculations for income-based payment plans under §O of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Frequency of Recalculation. A hospital may not seek a recalculation of the monthly payment amount under an income-based payment plan, as provided for under §O(1) of this regulation more than once every 3 years.</text> </paragraph> <paragraph num="(5)"> <text>Treatment of Missing Information. If a patient does not provide income information on the request of the hospital seeking to make a change to an income-based payment plan under §O of this regulation and the patient is in good standing on the patient's payments under the income-based payment plan, the hospital may not change the monthly payment amounts under the income-based payment plan.</text> </paragraph> </paragraph> <paragraph num="P."> <text>Treatment of Missed Payments.</text> <paragraph num="(1)"> <text>First Missed Payment.</text> <paragraph num="(a)"> <text>A hospital may not deem a patient to be noncompliant with an income-based payment plan if the patient makes at least 11 scheduled monthly payments within a 12-month period.</text> </paragraph> <paragraph num="(b)"> <text>Subject to §P(1)(c) of this regulation, the hospital shall permit the patient to repay the missed payment amount at any time, as determined by the patient, including through a set of partial payments.</text> </paragraph> <paragraph num="(c)"> <text>No later than 30 days after the first missed payment in a 12-month period, the hospital shall notify the patient of the missed payment and inform the patient that the patient may be in default if they do not pay the amount of the missed payment within 12 months or if they miss additional payments within the 12-month period. The notice will give the patient the option to pay the missed payment by paying the amount of the missed payments in one of the following ways:</text> <paragraph num="(i)"> <text>11 increments over the subsequent 11 months;</text> </paragraph> <paragraph num="(ii)"> <text>A single payment; or</text> </paragraph> <paragraph num="(iii)"> <text>Another approach, as specified by the patient.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>With respect to a patient that has missed a single monthly payment in a 12-month period, the hospital shall provide the patient with a method to designate whether any amount of a payment paid in the subsequent 12-month period is to be applied to the amount of missed payment or applied in a different manner.</text> </paragraph> <paragraph num="(e)"> <text>With respect to a patient that has missed a single monthly payment in a 12-month period, if the hospital receives a payment and the patient has not designated how that payment is to be applied, the hospital shall first apply the amount to any payment that is due in the 31-day period following the date the payment is received. If there is no payment due in the next month, the hospital shall apply the amount of the payment to the missed payment. If the amount of the payment exceeds the amount of any payment that is due in the 31-day period following the date the payment is received, the excess amount shall be applied to the missed payment.</text> </paragraph> <paragraph num="(f)"> <text>The hospital may consider a patient to be in default on the income-based payment plan if the missed payment is not repaid in full by the end of the 12-month period that begins on the date of the missed payment under §P(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Additional Missed Payments.</text> <paragraph num="(a)"> <text>A hospital may forbear the amount of any additional missed payments that occur in a 12-month period.</text> </paragraph> <paragraph num="(b)"> <text>If a hospital forbears the amount of any additional missed payments that occur in a 12-month period, the hospital shall allow the patient to continue to participate in the income-based payment plan.</text> </paragraph> <paragraph num="(c)"> <text>If a hospital forbears the amount of any additional missed payments that occur in a 12-month period, the hospital may not refer the outstanding balance owed to a collection agency or for legal action.</text> </paragraph> <paragraph num="(d)"> <text>The hospital shall recapitalize the amount of any missed payments that were subject to forbearance under this §P of this regulation as additional payments at the end of the income-based payment plan, thereby extending the length of the income-based payment plan.</text> </paragraph> <paragraph num="(e)"> <text>The hospital shall provide written notice to the patient of the treatment of the missed payments, including any extension of the length of the income-based payment plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="Q."> <text>Treatment of Loans and Extension of Credit. After a hospital service is provided to the patient, a hospital, hospital affiliate, or third-party in partnership with a hospital may not make any loan or extension of credit to the patient in connection with a medically necessary hospital service that is inconsistent with the guidelines for payment plans in this regulation resulting from that service.</text> </paragraph> <paragraph num="R."> <text>Application of Credit Provisions of Maryland Commercial Law Article and Licensing Provisions of Financial Institutions Article. An income-based payment plan is an extension of credit subject to Maryland credit regulations under Commercial Law Article, Title 12, Annotated Code of Maryland and any applicable licensing provisions of Financial Institutions Article, Title 11, Annotated Code of Maryland.</text> </paragraph> <paragraph num="S."> <text>Books and Records. A hospital shall retain books and records on income-based payment plans for at least 3 years after the income-based payment plan is closed.</text> </paragraph> <paragraph num="T."> <text>Default.</text> <paragraph num="(1)"> <text>If a patient defaults on an income-based payment plan and the parties are unable to agree to a modification, then the hospital shall follow the provisions of its credit and collection policy established in accordance with Regulation .04 of this chapter, before a hospital may write this medical debt off as bad debt.</text> </paragraph> <paragraph num="(2)"> <text>With respect to the amounts covered by the income-based payment plans, a patient who is on an income-based payment plan and is not in default on that payment plan may not be considered in arrears on their debt to the hospital when the hospital is making decisions about scheduling health care services.</text> </paragraph> </paragraph> <paragraph num="U."> <text>Non-Income-Based Payment Plans.</text> <paragraph num="(1)"> <text>Other Payment Plans Allowed. A hospital may offer a non-income-based payment plan under these Guidelines, but must first offer the patient an income-based payment plan.</text> </paragraph> <paragraph num="(2)"> <text>Application of Guidelines. Consistent with the Guidelines for Hospital Payment Plans and consistent with the intent of Health-General Article, §19-214.2, Annotated Code of Maryland, the following provisions of this regulation apply to non-income-based payment plans in the same manner such provisions apply to income-based payment plans:</text> <paragraph num="(a)"> <text>§A of this regulation, regarding scope;</text> </paragraph> <paragraph num="(b)"> <text>§B of this regulation, regarding access to payment plans;</text> </paragraph> <paragraph num="(c)"> <text>§C(2) of this regulation, regarding notice of payment plan terms before execution;</text> </paragraph> <paragraph num="(d)"> <text>§C(3) of this regulation, regarding notice of plan after execution;</text> </paragraph> <paragraph num="(e)"> <text>§D of this regulation, regarding financial assistance;</text> </paragraph> <paragraph num="(f)"> <text>§L of this regulation, regarding interest and fees;</text> </paragraph> <paragraph num="(g)"> <text>§M(1)(a) and (2) of this regulation, regarding early payments;</text> </paragraph> <paragraph num="(h)"> <text>§N(6) of this regulation, regarding modifications of payment plans;</text> </paragraph> <paragraph num="(i)"> <text>§Q of this regulation, relating to treatment of loans and extensions of credit;</text> </paragraph> <paragraph num="(j)"> <text>§R of this regulation, relating to the application of credit provisions of Maryland Commercial Law Article and the licensing provisions of Financial Institutions Article;</text> </paragraph> <paragraph num="(k)"> <text>§S of this regulation, relating to books and records; and</text> </paragraph> <paragraph num="(l)"> <text>§T of this regulation, relating to default.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notice.</text> <paragraph num="(a)"> <text>Notice of Terms Before Execution. In addition to complying with the terms of §C(2) of this regulation, the hospital must include notice that the patient may apply for an income-based payment plan at any time in the notice of terms before execution of a non-income-based payment plan.</text> </paragraph> <paragraph num="(b)"> <text>Notice of Plan After Execution. The hospital must include the notice required in §U(3)(a) of this regulation in the notice of the payment plan after execution that is required by §C(3) of this regulation.</text> </paragraph> <paragraph num="(c)"> <text>Notice with Bills. Each bill for a non-income-based payment plan shall include a notice that informs the patient that income-based payment plans are available, which could result in lower monthly payments and provides information on how to apply for such plans.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Consent. Before entering into a non-income-based repayment plan with a patient, the hospital must obtain consent from the patient that records that the patient affirms the following:</text> <paragraph num="(a)"> <text>The hospital offered the patient an income-based payment plan;</text> </paragraph> <paragraph num="(b)"> <text>The income-based payment plan limits monthly payment amounts to 5 percent of the patient’s monthly income;</text> </paragraph> <paragraph num="(c)"> <text>The income-based payment plan may result in lower monthly payment amounts than the monthly payment amounts under the non-income-based repayment plan;</text> </paragraph> <paragraph num="(d)"> <text>The patient has the opportunity to disclose their income and determine the payment amount under the income-based payment plan; and</text> </paragraph> <paragraph num="(e)"> <text>The patient is declining to enter an income-based payment plan and is consenting to enter a non-income-based repayment plan.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Modification of a Non-Income-Based Payment Plan: In addition to complying with the terms of §N(6) of this regulation, before modifying a non-income-based payment plan:</text> <paragraph num="(a)"> <text>The hospital shall offer the patient an income-based payment plan; and,</text> </paragraph> <paragraph num="(b)"> <text>If the patient declines the income-based payment plan, obtain the consent required under §U(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Default on a Non-Income-Based Payment Plan.</text> <paragraph num="(a)"> <text>If the patient defaults on a non-income-based payment plan, the hospital must offer an income-based payment plan to the patient before the hospital follows the provisions of its credit and collection policy to collect the debt.</text> </paragraph> <paragraph num="(b)"> <text>The offer provided under §U(6)(a) of this regulation must be sent separately from a bill.</text> </paragraph> </paragraph> </paragraph> <paragraph num="V."> <text>Steering.</text> <paragraph num="(1)"> <text>A hospital may not steer patients to non-income-based payment plans, or third-party credit providers, in such a manner that discourages patients from entering into income-based payment plans.</text> </paragraph> <paragraph num="(2)"> <text>A hospital may not steer patients to revolving credit products in such a manner that discourages patients from entering into either income-based payment plans or non-income based payment plans under this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Hospital Financial Assistance Responsibilities."> <paragraph num="A."> <text>Financial Assistance Policy.</text> <paragraph num="(1)"> <text>Requirements.</text> <paragraph num="(a)"> <text>Each hospital and each chronic care hospital under the jurisdiction of the Commission shall develop a written financial assistance policy for providing free and reduced-cost medically necessary care to low-income patients who lack health care coverage or to patients whose health insurance does not pay the full cost of the hospital bill.</text> </paragraph> <paragraph num="(b)"> <text>A hospital shall provide written notice of the hospital's financial assistance policy to the patient, the patient's family, or the patient's authorized representative before discharging the patient and in each communication to the patient regarding collection of the hospital bill.</text> <paragraph num="(i)"> <text>The required notice shall state that the patient has up to 240 days after the day the patient receives the initial hospital bill to apply for financial assistance from the hospital.</text> </paragraph> <paragraph num="(ii)"> <text>The hospital shall obtain documentation ensuring that the patient or the patient’s authorized representative acknowledges the patient’s receipt of the notice before discharging the patient.</text> </paragraph> <paragraph num="(iii)"> <text>If a patient chooses not to apply for financial assistance, the patient’s documented acknowledgement shall indicate that the patient is not applying for financial assistance on the day of the acknowledgment but may apply within 240 days immediately following the patient’s receipt of the initial hospital bill.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The financial assistance policy shall provide at a minimum:</text> <paragraph num="(i)"> <text>Free medically necessary care to patients with family income at or below 200 percent of the federal poverty level, consistent with the provisions of §A(2) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Reduced-cost medically necessary care to patients with family income between 200 and 300 percent of the federal poverty level, consistent with the provisions of §A(2) of this regulation;</text> </paragraph> <paragraph num="(iii)"> <text>A description of the payment plan required under Health-General Article, §19-214.2(d), Annotated Code of Maryland and Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(iv)"> <text>A mechanism for a patient, irrespective of that patient’s insurance status, to request the hospital to reconsider the denial of free or reduced-cost medically necessary care, including the address, phone number, facsimile number, email address, mailing address, and website of the Health Education and Advocacy Unit, which can assist the patient or patient’s authorized representative in filing and mediating a reconsideration request.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If a patient is eligible for reduced-cost medically necessary care under §A(1)(c)(ii) of this regulation, the hospital shall, at a minimum, reduce the patient’s out-of-pocket expenses for the hospital services:</text> <paragraph num="(i)"> <text>For a patient with family income of at least 201 percent but not more than 250 percent of the federal poverty level, by 75 percent; and</text> </paragraph> <paragraph num="(ii)"> <text>For a patient with family income of more than 250 percent but not more than 300 percent of the federal poverty level, by 60 percent.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>The hospital shall provide free and reduced-cost medically necessary care to all qualified Maryland residents, regardless of their citizenship or immigration status.</text> </paragraph> <paragraph num="(f)"> <text>The hospital shall provide free and reduced-cost medically necessary care under §A(1)(c) of this regulation to all qualified Maryland residents, regardless of whether the patient resides in the hospital’s service area.</text> </paragraph> <paragraph num="(g)"> <text>The financial assistance policy applies to all medically necessary hospital services provided to qualified Maryland residents. Hospitals may not exclude non-urgent or elective, but medically necessary, care from their financial assistance policy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The financial assistance policy shall calculate a patient’s eligibility for free medically necessary care under §A(1)(c)(i) of this regulation and Health-General Article, §19-214.1(b)(2)(i), Annotated Code of Maryland, or reduced-cost medically necessary care under §A(1)(c)(ii) of this regulation and Health-General Article, §19-214.1(b)(2)(ii), Annotated Code of Maryland, at the date of service or updated, as appropriate, to account for any change in the financial circumstances of the patient that occurs within 240 days after the initial bill is provided.</text> </paragraph> <paragraph num="(3)"> <text>The hospital shall consider any change in the patient’s financial circumstance in accordance with Health-General Article, §19-214.1(b)(11), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>Income Documentation.</text> <paragraph num="(a)"> <text>Hospitals shall accept generally acceptable forms of documentation that verify income, such as tax returns, pay stubs, and W2s to evaluate if the patient is eligible for financial assistance, including free and reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, in accordance with this regulation .</text> </paragraph> <paragraph num="(b)"> <text>Hospitals shall use available information, including information provided by the patient, to approximate the patient’s income if the patient has not provided their tax returns, pay stubs, W2s, or another form of documentation.</text> </paragraph> <paragraph num="(c)"> <text>Income Attestations.</text> <paragraph num="(i)"> <text>Hospitals may accept patient attestation of the patient’s monthly or annual income and the number of filers and dependents on their tax return without documentation.</text> </paragraph> <paragraph num="(ii)"> <text>Such an attestation shall include the patient’s income and the number of filers and dependents on their tax return.</text> </paragraph> <paragraph num="(iii)"> <text>If the patient provides an attestation of income the hospital is not required to conduct any additional income verification.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A hospital’s inability to obtain complete income information does not preclude the hospital's ability to reasonably predict a patient’s income for the purposes of providing financial assistance. For example, a hospital may multiply income reported at the monthly level by 12 to determine income at the annual level, allowing for reasonably predictable changes in income throughout the year.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Presumptive Eligibility for Free Medically Necessary Care. Unless otherwise eligible for Medicaid or CHIP, patients who are beneficiaries/recipients of the following means-tested social services programs are deemed eligible for free medically necessary care:</text> <paragraph num="(a)"> <text>Households with a child in the free or reduced lunch program and is eligible for the program based on the household’s income;</text> </paragraph> <paragraph num="(b)"> <text>Supplemental Nutritional Assistance Program (SNAP);</text> </paragraph> <paragraph num="(c)"> <text>Low-income-household energy assistance program;</text> </paragraph> <paragraph num="(d)"> <text>Primary Adult Care Program (PAC), until such time as inpatient benefits are added to the PAC benefit package;</text> </paragraph> <paragraph num="(e)"> <text>Women, Infants and Children (WIC); or</text> </paragraph> <paragraph num="(f)"> <text>Other means-tested social services programs deemed eligible for hospital free medically necessary care policies by the Maryland Department of Health and the Commission, consistent with this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Hospital Reports. Each hospital shall submit to the Commission within 120 days after the end of each hospital’s fiscal year:</text> <paragraph num="(1)"> <text>The hospital’s financial assistance policy developed in accordance with this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>An annual report on the hospital's financial assistance policy that includes:</text> <paragraph num="(a)"> <text>The total number of patients who completed or partially completed an application for financial assistance during the prior year;</text> </paragraph> <paragraph num="(b)"> <text>The total number of inpatients and outpatients who received free medically necessary care during the immediately preceding year and reduced-cost medically necessary care for the prior year;</text> </paragraph> <paragraph num="(c)"> <text>The total number of patients who received financial assistance during the immediately preceding year, by race or ethnicity and gender;</text> </paragraph> <paragraph num="(d)"> <text>The total number of patients who were denied financial assistance during the immediately preceding year, by race or ethnicity and gender;</text> </paragraph> <paragraph num="(e)"> <text>The total cost of hospital services provided to patients who received free medically necessary care; and</text> </paragraph> <paragraph num="(f)"> <text>The total cost of hospital services provided to patients who received reduced-cost medically necessary care that was covered by the hospital as financial assistance or that the hospital charged to the patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Financial Hardship Policy.</text> <paragraph num="(1)"> <text>Subject to Regulation .05D of this chapter, the financial assistance policy required under §A of this regulation and Health-General Article, §19-214.1, Annotated Code of Maryland, shall provide reduced-cost medically necessary care to patients with family income below 500 percent of the federal poverty level who have a financial hardship.</text> </paragraph> <paragraph num="(2)"> <text>If a patient has received reduced-cost medically necessary care due to a financial hardship, the patient or any immediate family member of the patient living in the same household:</text> <paragraph num="(a)"> <text>Shall remain eligible for reduced-cost medically necessary care when seeking subsequent care at the same hospital during the 12-month period beginning on the date on which the reduced-cost medically necessary care was initially received; and</text> </paragraph> <paragraph num="(b)"> <text>To avoid an unnecessary duplication of the hospital’s determination of eligibility for free and reduced-cost medically necessary care, shall inform the hospital of the patient’s or family member’s eligibility for the reduced-cost medically necessary care.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a patient is eligible for reduced-cost medically necessary care under a hospital’s financial hardship policy, the hospital shall, at a minimum, reduce the patient’s out-of-pocket expenses for hospital services:</text> <paragraph num="(a)"> <text>For a patient with family income of at least 201 percent but not more than 250 percent of the federal poverty level, by 75 percent;</text> </paragraph> <paragraph num="(b)"> <text>For a patient with family income of more than 250 percent but not more than 300 percent of the federal poverty level, by 60 percent;</text> </paragraph> <paragraph num="(c)"> <text>For a patient with family income of more than 300 percent but not more than 350 percent of the federal poverty level, by 50 percent;</text> </paragraph> <paragraph num="(d)"> <text>For a patient with family income of more than 350 percent but not more than 400 percent of the federal poverty level, by 45 percent;</text> </paragraph> <paragraph num="(e)"> <text>For a patient with family income of more than 400 percent but not more than 450 percent of the federal poverty level, by 40 percent; and</text> </paragraph> <paragraph num="(f)"> <text>For a patient with family income of more than 450 percent but not more than 500 percent of the federal poverty level, by 35.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The Commission may, by regulation, establish income thresholds higher than those in this regulation:</text> <paragraph num="(a)"> <text>Patient mix;</text> </paragraph> <paragraph num="(b)"> <text>Financial condition;</text> </paragraph> <paragraph num="(c)"> <text>Level of bad debt experienced;</text> </paragraph> <paragraph num="(d)"> <text>Amount of financial assistance provided; and</text> </paragraph> <paragraph num="(e)"> <text>Other relevant factors.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice Requirements.</text> <paragraph num="(1)"> <text>A notice shall be posted in conspicuous places throughout the hospital including the billing office informing patients of their right to apply for financial assistance and who to contact at the hospital for additional information.</text> </paragraph> <paragraph num="(2)"> <text>If the hospital uses a vendor to assist with financial assistance eligibility, billing, or debt collection, such as a debt collector or eligibility vendor, that vendor shall post a notice in a conspicuous place on their website or online payment portal, informing patients of their right to apply for financial assistance, providing a link to the financial assistance application, and providing information on how to submit the application. Placement on the website or online payment portal should be based on the best interest of the patient.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The notice required under §E of this regulation shall be in:</text> <paragraph num="(1)"> <text>Simplified language;</text> </paragraph> <paragraph num="(2)"> <text>At least 10-point type; and</text> </paragraph> <paragraph num="(3)"> <text>The patient’s preferred language or, if no preferred language is specified, each language spoken by a limited English proficient population that constitutes at least 5 percent of the overall population within the city or county in which the hospital is located as measured by the most recent census.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Financial Assistance Application. Each hospital shall:</text> <paragraph num="(1)"> <text>Use a Financial Assistance Application in the manner prescribed by the Commission in order to determine eligibility for free and reduced-cost medically necessary care;</text> </paragraph> <paragraph num="(2)"> <text>Use a Financial Assistance Application that meets the requirements of this regulation and is consistent with the Uniform Financial Assistance Application; and</text> </paragraph> <paragraph num="(3)"> <text>Establish a mechanism to provide a Financial Assistance Application to patients regardless of their insurance status. A hospital may require from patients or their guardians only those documents required to validate the information provided on the application.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Asset Test Requirements. A hospital may utilize a monetary asset test when determining eligibility for financial assistance, using the definition of monetary assets as defined in Regulation 01B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Patient Complaints."> <paragraph num="A."> <text>The Commission shall post a process on its website for a patient or a patient’s authorized representative to file with the Commission a complaint against a hospital for an alleged violation of Health-General Article, §§19-214.1 or 19-214.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The process established by the Commission shall include the option for a patient or a patient’s authorized representative to file the complaint jointly with the Commission and the Health Education and Advocacy Unit.</text> </paragraph> <paragraph num="C."> <text>The process shall conform to the requirements of Health-General Article, §19-214.3, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Hospital Written Estimate."> <paragraph num="A."> <text>In addition to the good faith estimate requirements set forth in the Public Health Service Act, 42 U.S.C §2799B-6, the No Surprises Act, on request of a patient made before or during treatment, a hospital shall provide to the patient a written estimate of the total charges for the hospital services, procedures, and supplies that reasonably are expected to be provided and billed to the patient by the hospital.</text> </paragraph> <paragraph num="B."> <text>The written estimate shall state clearly that it is only an estimate and actual charges could vary.</text> </paragraph> <paragraph num="C."> <text>A hospital may restrict the availability of a written estimate to normal business office hours.</text> </paragraph> <paragraph num="D."> <text>The provisions set forth in §A—C of this regulation do not apply to emergency services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Other Obligations of Debt Collectors."> <text>This chapter does not diminish any obligations of a debt collector, as defined under Regulation .01 of this chapter, under other applicable laws or regulations, including, without limitation, any requirement for the debt collector to obtain a collection agency license from the State Collection Agency Licensing Board in accordance with Business Regulation Article, Title 7, Subtitle 3, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-214.2, 19-214.3, 19-207, and 19-219, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 11, 2025 (52:24 Md. R. 1198)</annotation> </annotations> </chapter> </subtitle> <subtitle num="38" heading="Board of Physical Therapy Examiners"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approved agency” means an independent credentialing agency, approved by the Board, which evaluates the credentials of foreign-trained applicants.</text> </paragraph> <paragraph num="(2)"> <text>“Approved curriculum for physical therapist assistants” means a curriculum that is approved by the American Physical Therapy Association.</text> </paragraph> <paragraph num="(3)"> <text>“Approved physical therapy curriculum” means a curriculum for physical therapists that is approved by the American Medical Association or the American Physical Therapy Association.</text> </paragraph> <paragraph num="(4)"> <text>“Biennial renewal” means renewal every other year with even-numbered licenses being renewed in even-numbered years and odd-numbered licenses being renewed in odd-numbered years.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the Board of Physical Therapy Examiners of Maryland established by Health Occupations Article, §13-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Direct supervision” means supervision provided by a licensed physical therapist who is physically present within the treatment area and immediately available to give aid, direction, and instruction when physical therapy or limited physical therapy procedures or activities are performed.</text> </paragraph> <paragraph num="(7)"> <text>“Hearing committee” means a committee of three or more Board members that has been delegated the authority to conduct hearings in accordance with Health Occupations Article, §13-317, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Interview” means a meeting with the Board or with one or more of its representatives.</text> </paragraph> <paragraph num="(9)"> <text>Licensed Physical Therapist.</text> <paragraph num="(a)"> <text>“Licensed physical therapist” means an individual licensed by the Board to practice physical therapy in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>“Licensed physical therapist” includes an individual holding a compact privilege to practice physical therapy in Maryland.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Licensed Physical Therapist Assistant.</text> <paragraph num="(a)"> <text>“Licensed physical therapist assistant” means an individual licensed by the Board to practice limited physical therapy in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>“Licensed physical therapist assistant” includes an individual holding a compact privilege to practice limited physical therapy in Maryland.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Licensing examinations” means the written examinations approved by the Board consisting of the:</text> <paragraph num="(a)"> <text>National licensing examination; and</text> </paragraph> <paragraph num="(b)"> <text>Maryland Physical Therapy jurisprudence examination.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Ongoing supervision” means that the physical therapist maintains continuing verbal and written contact with the physical therapist assistant to provide supervision and instruction adequate to ensure the safety and welfare of the patient.</text> </paragraph> <paragraph num="(13)"> <text>“Oral competency” means that the applicant who did not graduate from a recognized English-speaking educational institution has obtained a passing score, as determined by the Board, on the Test of English as a Foreign Language administered by the Educational Testing Service.</text> </paragraph> <paragraph num="(14)"> <text>“Passing score” means the result of two examinations:</text> <paragraph num="(a)"> <text>The criterion-referenced score set by the Federation of State Boards of Physical Therapy; and</text> </paragraph> <paragraph num="(b)"> <text>90 percent of the total on the Maryland Physical Therapy jurisprudence examination.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Physical therapy aide” or “aide” means a person who performs certain physical therapy duties under the direct supervision of a licensed physical therapist. This individual may be known, also, as a physical therapist technician, a rehabilitation technician, an athletic trainer, or be described by some other similar title.</text> </paragraph> <paragraph num="(16)"> <text>“Reporting service” means the Interstate Reporting Service, an agency approved by the Board for the purpose of recording, storing, and transmitting license examination scores.</text> </paragraph> <paragraph num="(17)"> <text>“State” means:</text> <paragraph num="(a)"> <text>A state, possession, or territory of the United States;</text> </paragraph> <paragraph num="(b)"> <text>The District of Columbia; or</text> </paragraph> <paragraph num="(c)"> <text>The Commonwealth of Puerto Rico.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Student” means an individual who is supervised directly by a licensed physical therapist in a Board-approved physical therapy educational program.</text> </paragraph> <paragraph num="(19)"> <text>“Temporary license” means a license issued by the Board to an individual who has completed the approved curriculum requirements to practice, while under direct supervision, as a:</text> <paragraph num="(a)"> <text>Physical therapist; or</text> </paragraph> <paragraph num="(b)"> <text>Physical therapist assistant.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Verification” means confirmation of licensure obtained directly from the state in which the applicant is currently licensed, on a form provided by the Board.</text> </paragraph> <paragraph num="(21)"> <text>“Waiver of national licensing examination” means that the Board may waive the national licensing examination if the applicant previously took the examination in another state and met the requirements for a passing score as set forth in §B(14) of this regulation.</text> </paragraph> <paragraph num="(22)"> <text>“Written competency” means that the applicant who did not graduate from a recognized English-speaking educational institution has obtained a passing score, as determined by the Board, on the Test of English as a Foreign Language administered by the Educational Testing Service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Licensure."> <text>The following are requirements for an applicant educated in an approved physical therapy or approved physical therapist assistant curriculum in any state:</text> <paragraph num="A."> <text>Examination. The following shall be filed with the Board or the Board’s agent:</text> <paragraph num="(1)"> <text>An application on the form the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>The application and national licensing examination fees established in COMAR 10.38.07; and</text> </paragraph> <paragraph num="(3)"> <text>Proof of completion of:</text> <paragraph num="(a)"> <text>A physical therapy or physical therapist assistant curriculum; and</text> </paragraph> <paragraph num="(b)"> <text>Any clinical training required under the curriculum.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Transfer of Examination Scores. The following shall be filed with the Board or the Board’s agent:</text> <paragraph num="(1)"> <text>An application on the form the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>The application fee established in COMAR 10.38.07;</text> </paragraph> <paragraph num="(3)"> <text>Proof of completion of:</text> <paragraph num="(a)"> <text>A physical therapy or physical therapist assistant curriculum; and</text> </paragraph> <paragraph num="(b)"> <text>Any clinical training required under the curriculum;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A sworn statement that the applicant is not now nor has ever been licensed in another state;</text> </paragraph> <paragraph num="(5)"> <text>Evidence, satisfactory to the Board, that the applicant is registered to take, or has taken, the national licensing examination in another state; and</text> </paragraph> <paragraph num="(6)"> <text>A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Waiver of Examination. The following shall be filed with the Board or the Board’s agent:</text> <paragraph num="(1)"> <text>An application on the form the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>The application fee established in COMAR 10.38.07;</text> </paragraph> <paragraph num="(3)"> <text>Proof of completion of:</text> <paragraph num="(a)"> <text>A physical therapy or physical therapist assistant curriculum; and</text> </paragraph> <paragraph num="(b)"> <text>Any clinical training required under the curriculum;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A copy of a current physical therapy license;</text> </paragraph> <paragraph num="(5)"> <text>Verification of current license on the form the Board requires; and</text> </paragraph> <paragraph num="(6)"> <text>A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Additional Requirements. Applicants for licensure shall:</text> <paragraph num="(1)"> <text>Achieve a passing score on the licensing examinations; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13–302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reexamination."> <paragraph num="A."> <text>National Licensing Examination.</text> <paragraph num="(1)"> <text>An applicant who fails the examination shall repeat the examination.</text> </paragraph> <paragraph num="(2)"> <text>Fees.</text> <paragraph num="(a)"> <text>At least 6 weeks before the examination, the applicant shall pay to the Board the reexamination fee as established in COMAR 10.38.07.</text> </paragraph> <paragraph num="(b)"> <text>If the applicant has taken the licensing examination twice in Maryland, the applicant shall pay to the Board an application fee, as established in COMAR 10.38.07, in addition to the reexamination fee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Examination on Maryland Physical Therapy Law. An applicant who fails the examination on the Maryland Physical Therapy Practice Act and associated regulations shall:</text> <paragraph num="(1)"> <text>Repeat the examination; and</text> </paragraph> <paragraph num="(2)"> <text>Attend an interview unless the Board waives this requirement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Issuance of Licenses."> <paragraph num="A."> <text>Temporary License.</text> <paragraph num="(1)"> <text>The Board may issue a temporary license to an applicant who, except for passing an examination otherwise required under Health Occupations Article, Title 13, Annotated Code of Maryland, has met the appropriate education and experience requirements for a physical therapy license or a physical therapist assistant license set forth under Health Occupations Article, §13-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The holder of a temporary license shall:</text> <paragraph num="(a)"> <text>Practice under direct supervision while the temporary license is in effect;</text> </paragraph> <paragraph num="(b)"> <text>Achieve a passing score on the Maryland Physical Therapy jurisprudence exam; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13-302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A temporary license is valid until:</text> <paragraph num="(a)"> <text>90 days after issuance;</text> </paragraph> <paragraph num="(b)"> <text>The Board issues a full license to practice physical therapy or limited physical therapy to the holder of the temporary license; or</text> </paragraph> <paragraph num="(c)"> <text>The Board revokes the temporary license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure Procedures.</text> <paragraph num="(1)"> <text>When the applicant has met all the requirements for licensure, the Board may issue a physical therapist or physical therapist assistant license to the applicant.</text> </paragraph> <paragraph num="(2)"> <text>Renewal of Physical Therapist or Physical Therapist Assistant License.</text> <paragraph num="(a)"> <text>The licensee shall renew the license biennially.</text> </paragraph> <paragraph num="(b)"> <text>The licensee shall be responsible for notifying the Board if a renewal notice is not received.</text> </paragraph> <paragraph num="(c)"> <text>A renewal license shall be issued to each licensee who meets the requirements of Health Occupations Article, §13-311(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Method of Renewal Notification.</text> <paragraph num="(a)"> <text>Except as otherwise provided in §B(3)(b) of this regulation, the Board shall mail notices for renewal at least 1 month before the expiration date.</text> </paragraph> <paragraph num="(b)"> <text>If requested by a licensee, the Board shall send to the licensee, at least two times within the month before a license expires, a renewal notice by electronic means to the last known electronic mail address of the licensee.</text> </paragraph> <paragraph num="(c)"> <text>If a renewal notice sent by electronic mail under §B(3)(b) of this regulation is returned to the Board as undeliverable, the Board shall send to the licensee a renewal notice by first-class mail to the last known address of the licensee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A duplicate license shall be issued for a lost, stolen, or destroyed license provided the licensee:</text> <paragraph num="(a)"> <text>Makes a request in writing;</text> </paragraph> <paragraph num="(b)"> <text>Provides a sworn statement or police report attesting to the facts; and</text> </paragraph> <paragraph num="(c)"> <text>Pays the fee as established in COMAR 10.38.07.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Restrictions."> <paragraph num="A."> <text>The Board may refuse to grant a license to any applicant who begins practice as a physical therapist or a physical therapist assistant before being licensed to practice in Maryland.</text> </paragraph> <paragraph num="B."> <text>Practice after the date of expiration of the license is prohibited.</text> </paragraph> <paragraph num="C."> <text>An applicant shall complete the application process within 1 year of the date of the paid application or reapply for licensure.</text> </paragraph> <paragraph num="D."> <text>The Board may refuse to grant or renew a license to an applicant who has failed to pay all outstanding fees to the Board.</text> </paragraph> <paragraph num="E."> <text>The Board may not issue a license under this subtitle if the results of the criminal history records check required pursuant to Regulation .02D(3) of this chapter has not been received.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-101, 13-101, 13-206, 13-301—13-303, 13-305—13-307, 13-310, 13-311, 13-313, and 13-317, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 25, 1974 (1:6 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01J amended effective June 29, 1979 (6:13 Md. R. 1129)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed effective August 2, 1982 (9:15 Md. R. 1514)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted effective August 2, 1982 (9:15 Md. R. 1514)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed effective December 29, 1986 (13:26 Md. R. 2807)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted effective December 29, 1986 (13:26 Md. R. 2807)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 8, 1991 (18:13 Md. R. 1482); February 26, 1996 (23:4 Md. R. 273); July 12, 1999 (26:14 Md. R. 1083) Regulation .01B amended as an emergency provision effective January 1, 2001 (28:3 Md. R. 203); amended permanently effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 24, 2006 (33:8 Md. R. 734); April 6, 2009 (36:7 Md. R. 525); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A—C amended effective July 8, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 8, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 6, 2009 (36:7 Md. R. 525); April 2, 2012 (39:6 Md. R. 408); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 8, 1991 (18:13 Md. R. 1482); July 12, 1999 (26:14 Md. R. 1083)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 12, 1999 (26:14 Md. R. 1083)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective July 8, 1991 (18:13 Md. R. 1482)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective June 8, 2015 (42:11 Md. R. 725)</annotation> </annotations> </chapter> <chapter num="02" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Code of Ethics."> <paragraph num="A."> <text>The physical therapist and physical therapist assistant shall provide care regardless of the patient's:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Religion;</text> </paragraph> <paragraph num="(3)"> <text>Color;</text> </paragraph> <paragraph num="(4)"> <text>Age;</text> </paragraph> <paragraph num="(5)"> <text>National origin;</text> </paragraph> <paragraph num="(6)"> <text>Marital status;</text> </paragraph> <paragraph num="(7)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(8)"> <text>Gender identity; or</text> </paragraph> <paragraph num="(9)"> <text>Disability.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The physical therapist and the physical therapist assistant shall respect the dignity of the patient.</text> </paragraph> <paragraph num="C."> <text>The physical therapist and physical therapist assistant shall protect the patient's right to privacy by not divulging confidential information without consent of the patient or guardian unless required by law.</text> </paragraph> <paragraph num="D."> <text>The physical therapist shall provide information about fees upon request by the patient.</text> </paragraph> <paragraph num="E."> <text>The physical therapist may not dispense or supply physical therapy equipment unless it is in the best interest of the patient.</text> </paragraph> <paragraph num="F."> <text>The physical therapist and physical therapist assistant shall report to the Board of Physical Therapy Examiners all information that indicates a person is allegedly performing, or aiding and abetting, the illegal or unsafe practice of physical therapy.</text> </paragraph> <paragraph num="G."> <text>The physical therapist and the physical therapist assistant shall comply with the probationary conditions of a Board order.</text> </paragraph> <paragraph num="H."> <text>A licensee shall notify the Board in writing within 60 days if any license, certificate, permit, or registration granted by another state for the practice of physical therapy or limited physical therapy has been limited, restricted, suspended, revoked, or subjected to other disciplinary action by the licensing or certifying authority.</text> </paragraph> <paragraph num="I."> <text>The physical therapist and physical therapist assistant shall provide and maintain medical records in accordance with Health-General Article, §§4-301—4-402, Annotated Code of Maryland.</text> </paragraph> <paragraph num="J."> <text>The physical therapist or physical therapist assistant may not knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record or billing record or other information about a patient in an effort to conceal the information from use as evidence in an administrative, civil, or criminal proceeding.</text> </paragraph> <paragraph num="K."> <text>The physical therapist or physical therapist assistant may not intimidate or influence any person to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="L."> <text>The physical therapist or physical therapist assistant may not hinder, prevent, or otherwise delay any person from making information available to the Board in furtherance of any investigation of the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Sexual Misconduct."> <paragraph num="A."> <text>A physical therapist or physical therapist assistant may not engage in sexual misconduct.</text> </paragraph> <paragraph num="B."> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client or patient in the context of a professional evaluation, treatment, procedure, or service to the client or patient, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client or patient under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a patient;</text> </paragraph> <paragraph num="(4)"> <text>Sexual advances requesting sexual favors;</text> </paragraph> <paragraph num="(5)"> <text>Therapeutically inappropriate or intentional touching of a sexual nature;</text> </paragraph> <paragraph num="(6)"> <text>A verbal comment of a sexual nature;</text> </paragraph> <paragraph num="(7)"> <text>Physical contact of a sexual nature with a patient;</text> </paragraph> <paragraph num="(8)"> <text>Discussion of unnecessary sexual matters while treating a patient;</text> </paragraph> <paragraph num="(9)"> <text>The taking of photographs of patients for a sexual purpose;</text> </paragraph> <paragraph num="(10)"> <text>Sexual harassment of staff or students;</text> </paragraph> <paragraph num="(11)"> <text>An unnecessary sensual act or comment; or</text> </paragraph> <paragraph num="(12)"> <text>Sexual contact with an incompetent or unconscious patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of Regulation .01 or .02 of this chapter may result in the Board taking action to reprimand a licensee or place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $5,000.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-1004; Health Occupations Article, §§1-212, 13-206, and 13-316; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 6, 1979 (6:7 Md. R. 577)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new regulations .01 and .02 adopted effective August 2, 1982 (9:15 Md. R. 1514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01G adopted effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01H—L adopted effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 7, 1994 (21:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended and recodified to Regulation .03 and new Regulation .02 adopted effective September 6, 1999 (26:18 Md. R. 1376)</annotation> </annotations> </chapter> <chapter num="03" heading="Standards of Practice"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Physical Therapy Examiners of Maryland created by Health Occupations Article, §13-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Clinical treatment hour” means an hour in which physical therapy or limited physical therapy services are provided at some point during the hour.</text> </paragraph> <paragraph num="(3)"> <text>“Electronically signed” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.</text> </paragraph> <paragraph num="(4)"> <text>“Evaluations” means procedures which include, but are not limited to:</text> <paragraph num="(a)"> <text>Testing of strength, sensation, and reflexes;</text> </paragraph> <paragraph num="(b)"> <text>Goniometric measurements and their interpretation;</text> </paragraph> <paragraph num="(c)"> <text>Assessments of function, muscle tone, developmental levels, accessory motions, posture, and pain scale.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Goals” means the expected outcome as the result of therapy.</text> </paragraph> <paragraph num="(6)"> <text>“Group therapy” means treatment procedures provided simultaneously to two or more patients that:</text> <paragraph num="(a)"> <text>Require constant attendance, but not one-on-one contact by the physical therapist or physical therapist assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Can be, but need not be, the same treatment procedures.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>"History" means data that is pertinent to the current physical therapy problem.</text> </paragraph> <paragraph num="(8)"> <text>“Hour” means a 60-minute increment during a calendar day which is calculated by dividing the day into consecutive 60-minute increments beginning when the day's first physical therapy or limited physical therapy service starts and ending when the last physical therapy or limited physical therapy service terminates, the last consecutive increment of which may be a fraction of an hour.</text> </paragraph> <paragraph num="(9)"> <text>“Interpretation” means the analysis of findings for the purpose of establishing and justifying the plan of care.</text> </paragraph> <paragraph num="(10)"> <text>“License number” means the Maryland physical therapy license number issued by the Board.</text> </paragraph> <paragraph num="(11)"> <text>“Onset” means the date of occurrence of the condition for which physical therapy is being provided.</text> </paragraph> <paragraph num="(12)"> <text>“Physical therapy diagnosis” means the condition for which physical therapy is provided if different from the medical diagnosis.</text> </paragraph> <paragraph num="(13)"> <text>“Plan of care” means the plan of treatment aimed at achieving the anticipated functional goals.</text> </paragraph> <paragraph num="(14)"> <text>“Progress” means the measurable improvement as related to goals.</text> </paragraph> <paragraph num="(15)"> <text>“Reevaluation” means a measurement of progress, or lack of it, based on comparisons of tests, measurements, and assessments with previous evaluation or reevaluations.</text> </paragraph> <paragraph num="(16)"> <text>“Requirements for documentation” means the requirements as set forth in Regulation .02-1 of this chapter and approved by the Board.</text> </paragraph> <paragraph num="(17)"> <text>“Response to treatment” means a brief statement of the patient's condition at conclusion of treatment.</text> </paragraph> <paragraph num="(18)"> <text>“Services” means the evaluation or treatment, or both, as appropriate, of a patient.</text> </paragraph> <paragraph num="(19)"> <text>“Signature and title” means the name of the physical therapist or physical therapist assistant written by that person or electronically signed by that person in accordance with federal and State law and followed by the title “PT” or “PTA” and license number. A stamp of a signature is not acceptable as a signature for documentation.</text> </paragraph> <paragraph num="(20)"> <text>“Student” means an individual who is currently enrolled in a physical therapy or physical therapist assistant educational program approved by the Board.</text> </paragraph> <paragraph num="(21)"> <text>“Supervising physical therapist” means a physical therapist who provides ongoing supervision to a physical therapist assistant regarding the care of a patient.</text> </paragraph> <paragraph num="(22)"> <text>“Supportive personnel” includes aides and other unlicensed personnel.</text> </paragraph> <paragraph num="(23)"> <text>“Test results” means the measurable and objective findings obtained from the evaluations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Standards of Practice."> <paragraph num="A."> <text>Physical Therapists.</text> <paragraph num="(1)"> <text>The physical therapist who establishes or changes the plan of care shall be ultimately responsible for patient care until another physical therapist:</text> <paragraph num="(a)"> <text>Provides services to the patient; or</text> </paragraph> <paragraph num="(b)"> <text>Provides supervision to the treating physical therapist assistant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The physical therapist shall:</text> <paragraph num="(a)"> <text>Exercise sound professional judgment in the use of evaluation and treatment procedures;</text> </paragraph> <paragraph num="(b)"> <text>Provide:</text> <paragraph num="(i)"> <text>Physical therapy services to not more than an average of three patients per clinical treatment hour per calendar day, excluding group therapy; and</text> </paragraph> <paragraph num="(ii)"> <text>Each patient with adequate treatment time consistent with accepted standards in delivering physical therapy care;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide the patient with accurate information about the physical therapy services provided;</text> </paragraph> <paragraph num="(d)"> <text>Respect the right of the patient to refuse treatment;</text> </paragraph> <paragraph num="(e)"> <text>Evaluate the patient and develop a plan of care before the patient is treated;</text> </paragraph> <paragraph num="(f)"> <text>Work within the physical therapist's competency in physical therapy evaluation and treatment;</text> </paragraph> <paragraph num="(g)"> <text>Reevaluate the patient as the patient's condition requires, but at least every 30 days, unless the physical therapist, consistent with accepted standards of physical therapy care, documents in the treatment record an appropriate rationale for not reevaluating the patient;</text> </paragraph> <paragraph num="(h)"> <text>Provide direct supervision of students, aides, and individuals practicing under a temporary license;</text> </paragraph> <paragraph num="(i)"> <text>Ascertain and periodically reevaluate the ability of students and aides to perform the assigned duties;</text> </paragraph> <paragraph num="(j)"> <text>Delegate to the physical therapist assistant only treatment that is within the competency and scope of practice of the physical therapist assistant;</text> </paragraph> <paragraph num="(k)"> <text>Provide direction and instruction for the physical therapist assistant that is adequate to ensure the safety and welfare of the patient; and</text> </paragraph> <paragraph num="(l)"> <text>Document ongoing communication with the physical therapist assistant regarding changes in a patient's status and treatment plan.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The physical therapist may:</text> <paragraph num="(a)"> <text>Enter into an agreement or employment relationship provided that such agreement or relationship does not impede the physical therapist's exercise of independent judgment in the treatment of a patient or cause the physical therapist to practice physical therapy contrary to the Maryland Physical Therapy Act; and</text> </paragraph> <paragraph num="(b)"> <text>Decline to carry out evaluation or treatment of a patient who has been referred to the physical therapist by a health care practitioner if:</text> <paragraph num="(i)"> <text>In the physical therapist's judgment, the evaluation or treatment is contraindicated or unjustified; and</text> </paragraph> <paragraph num="(ii)"> <text>The physical therapist documents the decision in the patient's record.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Physical Therapist Assistants.</text> <paragraph num="(1)"> <text>The physical therapist assistant shall:</text> <paragraph num="(a)"> <text>Follow the direction and plan of care of the physical therapist in the treatment of a patient;</text> </paragraph> <paragraph num="(b)"> <text>Exercise sound judgment and adequate care in the performance of duties;</text> </paragraph> <paragraph num="(c)"> <text>Immediately discontinue any treatment procedure that appears to be harmful to the patient and so notify the supervising physical therapist;</text> </paragraph> <paragraph num="(d)"> <text>Use only methods and procedures within the scope of the practice of limited physical therapy;</text> </paragraph> <paragraph num="(e)"> <text>Respect the right of the patient to refuse treatment;</text> </paragraph> <paragraph num="(f)"> <text>Work within the physical therapist assistant's competency in treatment that is within the scope of practice of limited physical therapy;</text> </paragraph> <paragraph num="(g)"> <text>Document ongoing communication regarding changes in a patient's status and treatment authorized by the physical therapist; and</text> </paragraph> <paragraph num="(h)"> <text>Provide the following services:</text> <paragraph num="(i)"> <text>Treat not more than an average of three patients per clinical treatment hour per calendar day, excluding group therapy; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide each patient with adequate treatment time consistent with accepted standards in physical therapy care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The physical therapist assistant may:</text> <paragraph num="(a)"> <text>Enter into an agreement or employment relationship provided that the agreement or relationship does not impede the physical therapist assistant's exercise of appropriate patient treatment or cause the physical therapist assistant to practice limited physical therapy in violation of the Maryland Physical Therapy Act; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in the clinical education activities of a physical therapist assistant student if direct supervision of the student is provided by the physical therapist.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The physical therapist assistant may not initiate treatment until:</text> <paragraph num="(a)"> <text>The patient has been evaluated and the plan of care has been developed by a physical therapist; and</text> </paragraph> <paragraph num="(b)"> <text>A supervising physical therapist has been assigned to the physical therapist assistant.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Requirements for Documentation."> <paragraph num="A."> <text>The physical therapist shall document legibly the patient's chart each time the patient is seen for:</text> <paragraph num="(1)"> <text>The initial visit, by including the following information:</text> <paragraph num="(a)"> <text>Date;</text> </paragraph> <paragraph num="(b)"> <text>Condition, or diagnosis, or both, for which physical therapy is being rendered;</text> </paragraph> <paragraph num="(c)"> <text>Onset;</text> </paragraph> <paragraph num="(d)"> <text>History, if not previously recorded;</text> </paragraph> <paragraph num="(e)"> <text>Evaluation and results of tests (measurable and objective data);</text> </paragraph> <paragraph num="(f)"> <text>Interpretation;</text> </paragraph> <paragraph num="(g)"> <text>Goals;</text> </paragraph> <paragraph num="(h)"> <text>Modalities, or procedures, or both, used during the initial visit and the parameters involved including the areas of the body treated;</text> </paragraph> <paragraph num="(i)"> <text>Plan of care including suggested modalities, or procedures, or both, number of visits per week, and number of weeks; and</text> </paragraph> <paragraph num="(j)"> <text>Signature, title (PT), and license number.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Subsequent visits, by including the following information (progress notes):</text> <paragraph num="(a)"> <text>Date;</text> </paragraph> <paragraph num="(b)"> <text>Cancellations, no-shows;</text> </paragraph> <paragraph num="(c)"> <text>Modalities, or procedures, or both, with any changes in the parameters involved and areas of body treated;</text> </paragraph> <paragraph num="(d)"> <text>Objective status;</text> </paragraph> <paragraph num="(e)"> <text>Response to current treatment, if any;</text> </paragraph> <paragraph num="(f)"> <text>Changes in plan of care; and</text> </paragraph> <paragraph num="(g)"> <text>Signature, title (PT), and license number, although the flow chart may be initialed.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reevaluation, by including the following information in the report, which may be in combination with the visit note, if treated during the same visit:</text> <paragraph num="(a)"> <text>Date;</text> </paragraph> <paragraph num="(b)"> <text>Number of treatments since the initial evaluation or last reevaluation;</text> </paragraph> <paragraph num="(c)"> <text>Reevaluation, tests, and measurements of areas of body treated;</text> </paragraph> <paragraph num="(d)"> <text>Changes from previous objective findings;</text> </paragraph> <paragraph num="(e)"> <text>Interpretation of results;</text> </paragraph> <paragraph num="(f)"> <text>Goals met or not met and reasons;</text> </paragraph> <paragraph num="(g)"> <text>Updated goals;</text> </paragraph> <paragraph num="(h)"> <text>Updated plan of care including recommendations for follow-up; and</text> </paragraph> <paragraph num="(i)"> <text>Signature, title (PT), and license number;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Discharge, by including the following information in the discharge summary, which may be combined with the final visit note, if seen by the physical therapist on the final visit and written by the physical therapist:</text> <paragraph num="(a)"> <text>Date;</text> </paragraph> <paragraph num="(b)"> <text>Reason for discharge;</text> </paragraph> <paragraph num="(c)"> <text>Objective status;</text> </paragraph> <paragraph num="(d)"> <text>Recommendations for follow-up; and</text> </paragraph> <paragraph num="(e)"> <text>Signature, title (PT), and license number.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notwithstanding §A(4) of this regulation, a physical therapist may direct a physical therapist assistant to treat a patient on a final visit.</text> </paragraph> <paragraph num="C."> <text>The physical therapist assistant shall document the patient's chart each time the patient is seen by the physical therapist assistant following the physical therapist's initial evaluation or reevaluation by including the following:</text> <paragraph num="(1)"> <text>Date;</text> </paragraph> <paragraph num="(2)"> <text>Cancellations and no-shows;</text> </paragraph> <paragraph num="(3)"> <text>Modalities, procedures, or both, including parameters involved, and areas of body treated;</text> </paragraph> <paragraph num="(4)"> <text>Objective status;</text> </paragraph> <paragraph num="(5)"> <text>Response to treatment, if any;</text> </paragraph> <paragraph num="(6)"> <text>Continuation of plan as established by the physical therapist or change of plan as authorized by the physical therapist; and</text> </paragraph> <paragraph num="(7)"> <text>Signature, title (PTA), and license number, although the flow chart may be initialed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subsequent visits, as referred to in §A(2) of this regulation, in the same day by the same physical therapist do not require separate progress notes unless there is a change in the patient's status.</text> </paragraph> <paragraph num="E."> <text>Ongoing Communications. Both the physical therapist and the physical therapist assistant shall document ongoing communication between the physical therapist and physical therapist assistant regarding changes in a patient's status and treatment plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of these regulations may result in the Board taking action to reprimand a licensee, place a licensee on probation, or suspend or revoke a license. The Board may also impose a penalty not exceeding $5,000.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§13-206, 13-309, and 13-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 2, 1982 (9:15 Md. R. 1515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 1991 (19:1 Md. R. 33); December 19, 1994 (21:25 Md. R. 2106); April 16, 2001 (28:7 Md. R. 690); March 18, 2002 (29:5 Md. R. 504); March 31, 2003 (30:6 Md. R. 421); April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 31, 2003 (30:6 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective May 23, 2002 (29:12 Md. R. 924; amended permanently effective September 2, 2002 (29:17 Md. R. 1381)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 24, 2006 (33:8 Md. R. 734); February 25, 2008 (35:4 Md. R. 515); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02R amended effective January 1, 1996 (22:26 Md. R. 2030)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective January 20, 1992 (19:1 Md. R. 33)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1B amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 repealed and new Regulation .02-1 adopted effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 amended effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> </annotations> </chapter> <chapter num="04" heading="Physical Therapy Aide"> <regulation prefix="Regulation" num=".01" heading="Definition."> <paragraph num="A."> <text>In these regulations, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Physical therapy aide” or “aide” means a person who performs certain physical therapy duties under the direct supervision of a licensed physical therapist. This individual may be known, also, as a physical therapy technician, a rehabilitation technician, an athletic trainer, or be described by some other similar title.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements."> <paragraph num="A."> <text>Supervision.</text> <paragraph num="(1)"> <text>The physical therapy aide shall be under the direct supervision of a licensed physical therapist when performing those physical therapy treatments that the aide is permitted to perform.</text> </paragraph> <paragraph num="(2)"> <text>Exceptions. An aide may:</text> <paragraph num="(a)"> <text>Perform non-treatment-related activities, such as secretarial, clerical, and housekeeping duties without direct supervision;</text> </paragraph> <paragraph num="(b)"> <text>Perform patient-related activities that do not involve treatment (such as transporting patients, undressing and dressing patients, removing and applying assistive and supportive devices) without direct supervision;</text> </paragraph> <paragraph num="(c)"> <text>Assist a physical therapist assistant when more than one individual is required to ensure the safety and welfare of the patient during ambulation, transfers, or functional activities without direct supervision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In-Service Training. There shall be documented evidence of sufficient in-service training to assure safe performance of the duties assigned to the aide.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Activities Which May Be Performed by Aides under Direct Supervision."> <text>The following activities may be performed by aides under direct supervision:</text> <paragraph num="A."> <text>Assist in the practice of gait and ambulation;</text> </paragraph> <paragraph num="B."> <text>Assist in the practice of functional activities;</text> </paragraph> <paragraph num="C."> <text>Assist in the practice of transfers;</text> </paragraph> <paragraph num="D."> <text>Assist in the routine follow-up of specific exercises;</text> </paragraph> <paragraph num="E."> <text>Assist in the application of hot or cold packs;</text> </paragraph> <paragraph num="F."> <text>Assist in the procedure of Hubbard tank;</text> </paragraph> <paragraph num="G."> <text>Assist in the procedure of whirlpool;</text> </paragraph> <paragraph num="H."> <text>Assist in the application of contrast bath;</text> </paragraph> <paragraph num="I."> <text>Assist in the application of infrared; and</text> </paragraph> <paragraph num="J."> <text>Assist in the application of paraffin bath.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Prohibited Activities."> <paragraph num="A."> <text>Evaluation may not be performed by aides.</text> </paragraph> <paragraph num="B."> <text>Treatments other than those listed in Regulation .03 of this chapter may not be performed by aides.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalty."> <text>A physical therapy aide who violates the above regulations shall be considered by the Board to be practicing physical therapy in violation of the Maryland Physical Therapy Practice Act and may be referred to the appropriate State's Attorney's Office with a recommendation by the Board that the physical therapy aide be prosecuted.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §13-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 8, 1982 (9:22 Md. R. 2197)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 1, 1999 (26:22 Md. R. 1693)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 25, 2000 (27:25 Md. R. 2282)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective November 1, 1999 (26:22 Md. R. 1693)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 1, 1999 (26:22 Md. R. 1693); December 25, 2000 (27:25 Md. R. 2282)</annotation> </annotations> </chapter> <chapter num="05" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Physical Therapy Examiners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions"> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case which the Board has delegated to the Office of Administrative Hearings pursuant to State Government Article, §10-205, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges issued by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(4)"> <text>“Case resolution conference” means a voluntary, informal, and confidential meeting between the parties to a contested case and the Board’s case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference committee” means a committee comprised of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(6)"> <text>“Cease and desist order” means a public letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease doing a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed person to cease the unauthorized practice of physical therapy.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Charges” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Physical Therapy Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth sections of the Maryland Physical Therapy Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Complaint” means an allegation:</text> <paragraph num="(a)"> <text>That a licensee may have violated the Maryland Physical Therapy Act; and</text> </paragraph> <paragraph num="(b)"> <text>Which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Consent order” means a final order issued by the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a formal disciplinary action.</text> </paragraph> <paragraph num="(10)"> <text>“Contested case” means a proceeding conducted pursuant to the Administrative Procedure Act.</text> </paragraph> <paragraph num="(11)"> <text>“Final order” means a public record issued by the Board resolving a formal disciplinary action, either by consent or after an adjudication, which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license;</text> </paragraph> <paragraph num="(f)"> <text>Resolves the contested case by consent of the parties; or</text> </paragraph> <paragraph num="(g)"> <text>Takes any other action that the Board is authorized to do by law.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Formal disciplinary action” means action taken by the Board that:</text> <paragraph num="(a)"> <text>Is initiated by charges or a notice of initial denial;</text> </paragraph> <paragraph num="(b)"> <text>Is resolved by a consent order;</text> </paragraph> <paragraph num="(c)"> <text>Results in a summary suspension; or</text> </paragraph> <paragraph num="(d)"> <text>Results in a letter of surrender.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Hearing committee” means a committee of three or more members of the Board which conducts hearings.</text> </paragraph> <paragraph num="(14)"> <text>“Informal action” means that the Board closes a case, without any formal disciplinary action or without issuing a final order, by sending the licensee a:</text> <paragraph num="(a)"> <text>Letter of education; or</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means an informal action taken by the Board consisting of a nonpublic letter closing the case when the Board believes a licensee has engaged in conduct which violated the Maryland Physical Therapy Act.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may include a letter of agreement in which a licensee agrees to satisfy certain conditions in lieu of the Board issuing charges.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Letter of Education.</text> <paragraph num="(a)"> <text>“Letter of education” means an informal action taken by the Board consisting of a nonpublic letter in which the Board:</text> <paragraph num="(i)"> <text>Closes the case when the Board does not believe that the licensee’s conduct rose to the level of a violation of the Maryland Physical Therapy Act; and</text> </paragraph> <paragraph num="(ii)"> <text>Educates the licensee regarding the laws and standards of the practice of physical therapy.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Letter of education” may include a letter of agreement in which a licensee agrees to satisfy certain conditions.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Letter of surrender” means a public record accepted by the Board in which the licensee agrees to surrender the licensee’s license, which may include conditions for the Board’s acceptance of the surrender as a resolution of the case.</text> </paragraph> <paragraph num="(18)"> <text>“Licensee” means the holder of a license issued by the Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(19)"> <text>“Maryland Physical Therapy Act” means Health Occupations Article, Title 13, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, change a licensure status, or change some other benefit sought by the licensee.</text> </paragraph> <paragraph num="(21)"> <text>“Party” means:</text> <paragraph num="(a)"> <text>The respondent or any person named or admitted as a party, or properly seeking and entitled as a right to be a party in a formal disciplinary proceeding; or</text> </paragraph> <paragraph num="(b)"> <text>The administrative prosecutor from the Office of the Attorney General presenting a case on behalf of the Board.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Post-deprivation hearing” means a show cause or an evidentiary hearing scheduled by the Board after the Board has issued an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board’s basis for issuing the order of summary suspension.</text> </paragraph> <paragraph num="(23)"> <text>“Predeprivation hearing” means a show cause hearing at which the licensee has an opportunity to demonstrate to the Board why it should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension pursuant to State Government Article §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action which the Board is authorized to take.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Presiding officer” means the chair of the Board or, in the chair’s absence, a Board member designated by the chair, who:</text> <paragraph num="(a)"> <text>Conducts hearings before the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Issues prehearing orders.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Probation” means a sanction imposed by the Board in a public final order where the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions in order to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public pursuant to State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“Recommended decision” means a nonpublic record issued by a hearing committee or by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, and a proposed sanction, or any combination of these items.</text> </paragraph> <paragraph num="(28)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason which may interfere with the Board member’s participation in the case.</text> </paragraph> <paragraph num="(29)"> <text>“Respondent” means a licensee subject to the jurisdiction of the Board, who has been:</text> <paragraph num="(a)"> <text>Given formal notice of allegations concerning violations of the Maryland Physical Therapy Act; and</text> </paragraph> <paragraph num="(b)"> <text>Notified as to the possible imposition of sanctions or a summary suspension.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Revocation” means the removal of a licensee’s license.</text> </paragraph> <paragraph num="(31)"> <text>“Sanction” means an action by the Board which:</text> <paragraph num="(a)"> <text>Reprimands;</text> </paragraph> <paragraph num="(b)"> <text>Places on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fines;</text> </paragraph> <paragraph num="(d)"> <text>Suspends or revokes a license; or</text> </paragraph> <paragraph num="(e)"> <text>Disciplines by way of a consent order.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Show cause hearing” means a nonevidentiary hearing in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or continue to take an action that the Board is legally authorized to take.</text> </paragraph> <paragraph num="(33)"> <text>“Summary suspension” means the indefinite suspension of a license pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes emergency action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(34)"> <text>“Suspension” means the temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specified period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings’ proceedings involving the adjudication of a Board formal disciplinary action and the administrative law judge’s recommended decision are confidential.</text> </paragraph> <paragraph num="C."> <text>The respondent may not waive the confidentiality of the:</text> <paragraph num="(1)"> <text>Proceedings; or</text> </paragraph> <paragraph num="(2)"> <text>Patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To the extent possible, even after the close of a formal disciplinary action, the parties shall refrain from revealing the identity of any patients involved in the matter, including but not limited to, information contained in:</text> <paragraph num="(1)"> <text>Legal documents; or</text> </paragraph> <paragraph num="(2)"> <text>Oral statements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel at any stage of a formal disciplinary action.</text> </paragraph> <paragraph num="B."> <text>If a hearing is held, the respondent shall be represented:</text> <paragraph num="(1)"> <text>In proper person; or</text> </paragraph> <paragraph num="(2)"> <text>By an attorney who has been:</text> <paragraph num="(a)"> <text>Admitted to the Maryland Bar; or</text> </paragraph> <paragraph num="(b)"> <text>Specially admitted to practice law pursuant to Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 16, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may request the Office of the Attorney General to participate in a hearing to present the case on behalf of the State.</text> </paragraph> <paragraph num="D."> <text>The member of the Office of the Attorney General presenting the case on behalf of the State shall have the same rights as any party with regard to:</text> <paragraph num="(1)"> <text>Submission of evidence;</text> </paragraph> <paragraph num="(2)"> <text>Examination and cross-examination of witnesses; and</text> </paragraph> <paragraph num="(3)"> <text>The filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may also request a member of the Office of the Attorney General to act as legal advisor to the Board on questions of:</text> <paragraph num="(1)"> <text>Procedure;</text> </paragraph> <paragraph num="(2)"> <text>Evidence; and</text> </paragraph> <paragraph num="(3)"> <text>Law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disposition of Complaints."> <paragraph num="A."> <text>For each complaint, after reviewing any completed investigative information or reports, the Board shall:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(3)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(4)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(5)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(6)"> <text>Vote to:</text> <paragraph num="(a)"> <text>Charge a licensee with a violation of the Maryland Physical Therapy Act;</text> </paragraph> <paragraph num="(b)"> <text>Consider the matter as a basis for a summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Initially deny a license or reinstatement of a license; or</text> </paragraph> <paragraph num="(d)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not it has voted to charge a licensee with violations of the Maryland Physical Therapy Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Notice of Charges or Notice of Initial Denial."> <paragraph num="A."> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(1)"> <text>Served on the respondent by certified mail at the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Hand-delivered in person.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Charges or notice of initial denial shall:</text> <paragraph num="(1)"> <text>Inform the respondent of the statutory basis for the charges or denial of a license;</text> </paragraph> <paragraph num="(2)"> <text>Allege sufficient facts that the Board believes constitute either a basis for:</text> <paragraph num="(a)"> <text>Violation of the Maryland Physical Therapy Act; or</text> </paragraph> <paragraph num="(b)"> <text>Denial of a license; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include the notice of hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval from the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Notice of Hearing."> <paragraph num="A."> <text>Except for a show cause hearing, written notice of all hearings shall be sent by the Executive Director or an officer of the Board to all parties at least 30 days before the hearing.</text> </paragraph> <paragraph num="B."> <text>The Board shall serve the notice of hearing by either:</text> <paragraph num="(1)"> <text>Certified mail at the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Hand-delivery in person.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice of hearing shall state, if applicable:</text> <paragraph num="(1)"> <text>The date, time, place, and nature of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>The right to call witnesses and submit documents or other relevant evidence;</text> </paragraph> <paragraph num="(3)"> <text>The right to request subpoenas for witnesses and evidence and the costs associated with such a request;</text> </paragraph> <paragraph num="(4)"> <text>The right to representation;</text> </paragraph> <paragraph num="(5)"> <text>That a failure to appear for the scheduled hearing may result in an adverse action against the party; and</text> </paragraph> <paragraph num="(6)"> <text>That the parties may agree to the evidence and waive their right to appear at the hearing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The notice of hearing may include:</text> <paragraph num="(1)"> <text>Deadlines for discovery and motions; or</text> </paragraph> <paragraph num="(2)"> <text>Dates for the prehearing conference and case resolution conference.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Prehearing Conference and Case Resolution Conference."> <paragraph num="A."> <text>The Board may set a prehearing conference or a case resolution conference, or both.</text> </paragraph> <paragraph num="B."> <text>The prehearing conference may be used to prepare for the hearing by:</text> <paragraph num="(1)"> <text>Delineating the issues;</text> </paragraph> <paragraph num="(2)"> <text>Stipulating to facts, laws, and other matters;</text> </paragraph> <paragraph num="(3)"> <text>Arranging a schedule for the exchange of documents and witnesses;</text> </paragraph> <paragraph num="(4)"> <text>Arranging a schedule for the submission of motions and responses to motions; or</text> </paragraph> <paragraph num="(5)"> <text>Addressing any other matters that will promote the orderly and efficient conduct of the hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prehearing Orders.</text> <paragraph num="(1)"> <text>If a prehearing conference has been held, a prehearing order may be issued by the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The prehearing order shall set forth the actions taken or to be taken with regard to any matter addressed at the prehearing conference.</text> </paragraph> <paragraph num="(3)"> <text>If a prehearing conference is not held, the presiding officer may issue a prehearing order to regulate the conduct of the proceedings.</text> </paragraph> <paragraph num="(4)"> <text>Absent an exception from the presiding officer, the prehearing order shall be binding on the parties.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discoverable or available through another source.</text> </paragraph> <paragraph num="(2)"> <text>The Board is not bound by the recommendations of the case resolution conference committee and may:</text> <paragraph num="(a)"> <text>Modify the proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing on the matter, regardless of whether or not the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(4)"> <text>Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Motions.</text> <paragraph num="(1)"> <text>General Requirements.</text> <paragraph num="(a)"> <text>Unless otherwise set forth in a prehearing order or notice of hearing, all motions shall be:</text> <paragraph num="(i)"> <text>Accompanied by a memorandum of points and authorities; and</text> </paragraph> <paragraph num="(ii)"> <text>Filed with the Board at least 15 working days before the hearing.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A copy of the motion shall be served on the opposing party.</text> </paragraph> <paragraph num="(c)"> <text>A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party.</text> </paragraph> <paragraph num="(d)"> <text>The Board may refuse to consider a motion or response that is not timely filed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Motion for Summary Decision.</text> <paragraph num="(a)"> <text>A party may move for summary decision on any appropriate issue in the case.</text> </paragraph> <paragraph num="(b)"> <text>The Board may grant a proposed or final summary decision if the Board finds that:</text> <paragraph num="(i)"> <text>There is no genuine issue of material fact; and</text> </paragraph> <paragraph num="(ii)"> <text>A party is entitled to prevail as a matter of law.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Discovery."> <paragraph num="A."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §A(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert’s testimony, which includes the:</text> <paragraph num="(i)"> <text>Opinion offered;</text> </paragraph> <paragraph num="(ii)"> <text>Factual basis for the opinion; and</text> </paragraph> <paragraph num="(iii)"> <text>Reasons underlying the opinion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert’s report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Both parties have a continuing duty to supplement their disclosure of witnesses and documents.</text> </paragraph> <paragraph num="E."> <text>Absent unforeseen circumstances that would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="G."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Evidentiary Hearings."> <paragraph num="A."> <text>Hearings shall be conducted pursuant to the Administrative Procedure Act.</text> </paragraph> <paragraph num="B."> <text>The Board may delegate its authority to conduct hearings to:</text> <paragraph num="(1)"> <text>A hearing committee of the Board; or</text> </paragraph> <paragraph num="(2)"> <text>The Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Confidentiality.</text> <paragraph num="(1)"> <text>Hearings are not open to the public.</text> </paragraph> <paragraph num="(2)"> <text>All records, including the hearing committee’s decision and the administrative law judge’s recommended decision, are confidential and sealed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Record. The Board shall prepare an official record of hearings which shall include all:</text> <paragraph num="(1)"> <text>Pleadings;</text> </paragraph> <paragraph num="(2)"> <text>Testimony;</text> </paragraph> <paragraph num="(3)"> <text>Exhibits; and</text> </paragraph> <paragraph num="(4)"> <text>Other memoranda or material filed in the proceeding.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Transcript.</text> <paragraph num="(1)"> <text>Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board.</text> </paragraph> <paragraph num="(2)"> <text>The stenographic record may not be transcribed, unless requested by a party or by the Board.</text> </paragraph> <paragraph num="(3)"> <text>The cost of any typewritten transcripts of any proceedings, or parts of the transcript, shall be paid by the party requesting the transcript.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Presiding Officer.</text> <paragraph num="(1)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Conduct a full, fair, and impartial hearing;</text> </paragraph> <paragraph num="(b)"> <text>Take action to avoid unnecessary delay in the disposition of the proceedings;</text> </paragraph> <paragraph num="(c)"> <text>Maintain order; and</text> </paragraph> <paragraph num="(d)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The presiding officer has the power to regulate the course of the hearing and the conduct of the parties, including the power to:</text> <paragraph num="(a)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(b)"> <text>Rule on offers of proof and admit relevant and material evidence;</text> </paragraph> <paragraph num="(c)"> <text>Consider and rule upon motions;</text> </paragraph> <paragraph num="(d)"> <text>Grant a continuance or postponement;</text> </paragraph> <paragraph num="(e)"> <text>Determine the order in which the parties shall present their cases;</text> </paragraph> <paragraph num="(f)"> <text>Limit unduly repetitious testimony;</text> </paragraph> <paragraph num="(g)"> <text>Reasonably limit the time for presentation; and</text> </paragraph> <paragraph num="(h)"> <text>Issue orders as necessary to:</text> <paragraph num="(i)"> <text>Secure procedural simplicity and administrative fairness; and</text> </paragraph> <paragraph num="(ii)"> <text>Eliminate unjustifiable expense and delay.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in State Government Article, §10-213, Annotated Code of Maryland, apply to hearings before the Board.</text> </paragraph> <paragraph num="(2)"> <text>A party may:</text> <paragraph num="(a)"> <text>Submit evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examine and cross-examine witnesses; and</text> </paragraph> <paragraph num="(c)"> <text>File objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer, or a person designated by the presiding officer for that purpose, may examine a witness called by a party.</text> </paragraph> <paragraph num="(5)"> <text>The presiding officer may call as a witness a person necessary to ensure a full and complete record.</text> </paragraph> <paragraph num="(6)"> <text>Any Board member may examine any witness.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Briefs.</text> <paragraph num="(1)"> <text>A party may submit a brief on the issues of fact and law involved in the hearing.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer may designate:</text> <paragraph num="(a)"> <text>The form of the brief;</text> </paragraph> <paragraph num="(b)"> <text>The number of copies to be submitted; and</text> </paragraph> <paragraph num="(c)"> <text>The date and time of submission.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may refuse to consider a brief that is not timely filed or fails to conform to requirements imposed by the presiding officer.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If a party who is the respondent in the proceedings fails to appear at a hearing after due notice, the Board may:</text> <paragraph num="(1)"> <text>Reschedule the hearing; or</text> </paragraph> <paragraph num="(2)"> <text>In the Board’s discretion, proceed upon the investigation, report, documents, witnesses, and records before it.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Any testimony taken by the Board shall be taken under oath.</text> </paragraph> <paragraph num="K."> <text>Decision and Order.</text> <paragraph num="(1)"> <text>A decision and order rendered by the Board shall:</text> <paragraph num="(a)"> <text>Be in writing; and</text> </paragraph> <paragraph num="(b)"> <text>Include the findings of fact and conclusions of law.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party’s attorney of record.</text> </paragraph> <paragraph num="(3)"> <text>The findings of fact, conclusions of law, and order shall be retained as a permanent record by the Board.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Judicial Review.</text> <paragraph num="(1)"> <text>A party who is aggrieved by a final decision of the Board under Health Occupations Article, §13-316, Annotated Code of Maryland, may seek judicial review of the Board’s decision.</text> </paragraph> <paragraph num="(2)"> <text>The judicial review shall be in accordance with the provisions of State Government Article, §§10-222 — 10-223, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Rehearings.</text> <paragraph num="(1)"> <text>Within 10 days after service on a party of the decision of the Board, the party may apply to the Board for rehearing.</text> </paragraph> <paragraph num="(2)"> <text>The application shall state the grounds for rehearing.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall grant or deny the application within 20 days of its submission to the Board.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise ordered, neither the rehearing nor the application for rehearing shall:</text> <paragraph num="(a)"> <text>Stay the enforcement of the order; or</text> </paragraph> <paragraph num="(b)"> <text>Excuse the persons affected by the order for failure to comply with the terms of the order.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>At a rehearing, the Board shall only consider facts not presented in the original proceeding, including facts arising after the date of the original proceeding.</text> </paragraph> <paragraph num="(6)"> <text>By new order, the Board may abrogate, change, or modify its original order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Recommended Decisions, Exceptions Hearings, and Oral Argument."> <paragraph num="A."> <text>If a case has been delegated to a hearing committee of the Board or to the Office of Administrative Hearings pursuant to State Government Article, §10-205, Annotated Code of Maryland, the hearing committee or administrative law judge shall prepare a recommended decision for consideration by a quorum of the Board.</text> </paragraph> <paragraph num="B."> <text>A quorum of the Board may include members of the hearing committee.</text> </paragraph> <paragraph num="C."> <text>The hearing committee shall issue a recommended decision within 90 days of the conclusion of the hearing. This 90-day time frame may be extended by a majority vote of a quorum of the Board.</text> </paragraph> <paragraph num="D."> <text>The Board shall notify the parties of the parties’ right to:</text> <paragraph num="(1)"> <text>File written exceptions to the recommended decision issued by the administrative law judge or the hearing committee; and</text> </paragraph> <paragraph num="(2)"> <text>Present oral argument to the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A party may file written exceptions to the recommended decision issued by the administrative law judge or the hearing committee within 30 days of receipt of the recommended decision.</text> </paragraph> <paragraph num="F."> <text>The party opposing the exceptions has 15 days to file a written response.</text> </paragraph> <paragraph num="G."> <text>The Board may refuse to consider exceptions or responses filed in violation of §§E and F of this regulation.</text> </paragraph> <paragraph num="H."> <text>Oral Arguments.</text> <paragraph num="(1)"> <text>If either party files exceptions, the Board shall schedule an oral argument to be held before a quorum of the Board.</text> </paragraph> <paragraph num="(2)"> <text>After oral argument, the Board shall prepare an order containing the:</text> <paragraph num="(a)"> <text>Accepted findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Conclusions of law; and</text> </paragraph> <paragraph num="(c)"> <text>Disposition.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may refuse to hear oral argument if exceptions are not timely filed.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Determine all procedural issues that are governed by this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Make any rulings reasonably necessary to facilitate the effectiveness and efficiency of oral argument; and</text> </paragraph> <paragraph num="(c)"> <text>Impose reasonable time limitations on oral argument and, ordinarily, limit the parties to 30 minutes each.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The party filing the exceptions shall proceed first.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the parties do not file timely exceptions and no oral argument is scheduled, a quorum of the Board shall consider the recommended decision issued by the administrative law judge or hearing committee.</text> </paragraph> <paragraph num="J."> <text>The Board shall prepare an order based on the Board’s review of the:</text> <paragraph num="(1)"> <text>Recommended decision of the administrative law judge or hearing committee;</text> </paragraph> <paragraph num="(2)"> <text>Record developed before the administrative law judge or hearing committee; and</text> </paragraph> <paragraph num="(3)"> <text>Any exceptions and responses filed by the parties.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Revocation of Hearing Authority from the Office of Administrative Hearings."> <paragraph num="A."> <text>Consistent with the provisions of State Government Article, §10-205, Annotated Code of Maryland, the Board may revoke authority delegated to the Office of Administrative Hearings by written notice.</text> </paragraph> <paragraph num="B."> <text>Criteria for Revocation of Authority in a Specific Case. The Board may revoke all or part of the Office of Administrative Hearings’ authority in a specific case if the case:</text> <paragraph num="(1)"> <text>Involves novel or unanticipated factual or legal issues;</text> </paragraph> <paragraph num="(2)"> <text>Has significant fiscal consequences to the Board;</text> </paragraph> <paragraph num="(3)"> <text>Involves policy issues of general applicability; or</text> </paragraph> <paragraph num="(4)"> <text>Is likely to have precedential value.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures for Revocation of the Office of Administrative Hearings’ Authority in a Specific Case.</text> <paragraph num="(1)"> <text>The Board shall provide written notice of a revocation of the Office of Administrative Hearings’ authority:</text> <paragraph num="(a)"> <text>To:</text> <paragraph num="(i)"> <text>All parties; and</text> </paragraph> <paragraph num="(ii)"> <text>The Office of Administrative Hearings; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>That includes:</text> <paragraph num="(i)"> <text>A brief statement of the reasons for the revocation;</text> </paragraph> <paragraph num="(ii)"> <text>Whether all or part of the Office of Administrative Hearings’ delegated authority has been revoked; and</text> </paragraph> <paragraph num="(iii)"> <text>If only part of the delegation has been revoked, the portions of the contested case for which the delegation has been revoked.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may revoke the Office of Administrative Hearings’ authority to decide a case at any time before the earlier of:</text> <paragraph num="(a)"> <text>Issuance of a ruling by the administrative law judge on a substantive issue; or</text> </paragraph> <paragraph num="(b)"> <text>Taking of oral testimony from the first witness.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A decision issued by the Board shall reflect that the Office of Administrative Hearings’ authority was revoked.</text> </paragraph> <paragraph num="(4)"> <text>The Board shall include as part of the record a copy of the revocation notice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Summary Suspensions."> <paragraph num="A."> <text>The Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(1)"> <text>A notice of an intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(2)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board votes to issue a notice of intent to summarily suspend or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="D."> <text>Service of the notice of intent to summarily suspend a license shall be made by:</text> <paragraph num="(1)"> <text>Hand delivery in person to the respondent;</text> </paragraph> <paragraph num="(2)"> <text>Certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(3)"> <text>Other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>A notice of intent to summarily suspend a license shall include, but is not limited to:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and which includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request an evidentiary hearing of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board:</text> <paragraph num="(i)"> <text>To show cause why the Board should not execute the order of summary suspension; and</text> </paragraph> <paragraph num="(ii)"> <text>Which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Predeprivation Hearing.</text> <paragraph num="(a)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent’s license should not be summarily suspended.</text> </paragraph> <paragraph num="(b)"> <text>The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(c)"> <text>The presiding officer:</text> <paragraph num="(i)"> <text>Shall determine all procedural issues;</text> </paragraph> <paragraph num="(ii)"> <text>May impose reasonable time limits on each party’s oral argument; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Order of Summary Suspension.</text> <paragraph num="(1)"> <text>The Board may order the summary suspension of a license without first issuing a notice of intent to summarily suspend or providing a respondent with a predeprivation hearing if the Board determines that the threat to public health, safety, and welfare requires the immediate suspension of the license.</text> </paragraph> <paragraph num="(2)"> <text>Post-Deprivation Hearing.</text> <paragraph num="(a)"> <text>The respondent shall be provided with a show cause hearing within a reasonable time after the effective date of the order of summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The show cause hearing pursuant to §F(2)(a) of this regulation shall:</text> <paragraph num="(i)"> <text>Be conducted before the Board as provided in §E(2) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>After a show cause hearing, if the Board votes to continue the summary suspension, the respondent may request an evidentiary hearing before the Board.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing:</text> <paragraph num="(a)"> <text>May be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be conducted pursuant to the Administrative Procedure Act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for the stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Enter into a consent order; or</text> </paragraph> <paragraph num="(d)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings is a:</text> <paragraph num="(a)"> <text>Final order of the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Public record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Surrender of a License."> <paragraph num="A."> <text>The Board may accept the surrender of a license.</text> </paragraph> <paragraph num="B."> <text>The Board may require conditions for surrender of a license, including but not limited to:</text> <paragraph num="(1)"> <text>The admission of a violation of the Maryland Physical Therapy Act;</text> </paragraph> <paragraph num="(2)"> <text>The admission of facts;</text> </paragraph> <paragraph num="(3)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(4)"> <text>Restrictions on future licensing;</text> </paragraph> <paragraph num="(5)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(6)"> <text>An agreement that the respondent may not again apply for a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A letter of surrender is a:</text> <paragraph num="(1)"> <text>Final order of the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Public record.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Probation and Violation of Probation."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board deems appropriate, including:</text> <paragraph num="(1)"> <text>Re-education or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Practicing physical therapy or limited physical therapy under supervision;</text> </paragraph> <paragraph num="(4)"> <text>Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board;</text> </paragraph> <paragraph num="(5)"> <text>Periodic review of a licensee’s practice;</text> </paragraph> <paragraph num="(6)"> <text>Periodic audits of a licensee’s billing practice;</text> </paragraph> <paragraph num="(7)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(8)"> <text>Limitation of the licensee’s practice;</text> </paragraph> <paragraph num="(9)"> <text>Drug screenings;</text> </paragraph> <paragraph num="(10)"> <text>Individual or group counseling or therapy;</text> </paragraph> <paragraph num="(11)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(12)"> <text>Any other condition the Board deems appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking release from probation shall do so only by petitioning the Board to terminate the probation when the:</text> <paragraph num="(1)"> <text>Specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>Licensee has successfully completed the conditions or acts required for release.</text> </paragraph> </paragraph> <paragraph num="D."> <text>At any time, if the Board has reason to believe that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action provided for in the final order in the event of a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board deems appropriate and which the Board is authorized to take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Board determines that the respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action provided for in the final order in the event of a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions or probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose any sanction or take any other action that the Board deems appropriate and is authorized to take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Reinstatement."> <paragraph num="A."> <text>A licensee shall petition the Board for a lifting of the suspension of a license or a reinstatement following revocation or surrender of a license.</text> </paragraph> <paragraph num="B."> <text>The Board may reinstate a license only in accordance with:</text> <paragraph num="(1)"> <text>The terms and conditions of the order of revocation or suspension;</text> </paragraph> <paragraph num="(2)"> <text>A letter of surrender;</text> </paragraph> <paragraph num="(3)"> <text>An order of reinstatement issued by the Board; or</text> </paragraph> <paragraph num="(4)"> <text>A final judgment in any proceeding for judicial review.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When a time period is not specified in the Board’s final order, a petition for reinstatement may not be considered by the Board before the expiration of 1 year after the date of the order.</text> </paragraph> <paragraph num="D."> <text>The form of a reinstated license shall:</text> <paragraph num="(1)"> <text>Be similar in every respect to an original license; and</text> </paragraph> <paragraph num="(2)"> <text>Bear the new date of issue.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee whose license has been revoked or surrendered for 3 years or more before filing a petition for reinstatement is not eligible for reinstatement but instead shall apply for initial licensure.</text> </paragraph> <paragraph num="F."> <text>If the Board grants reinstatement of a license, the Board may impose any restrictions or conditions on the license that the Board deems appropriate.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§13-206 and 13-317;State Government Article, §§10-205 and 10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 8, 1982 (9:22 Md. R. 2197)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective July 12, 1999 (26:14 Md. R. 1083)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 24, 2000 (27:1 Md. R. 77)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective January 1, 2001 (28:3 Md. R. 203); amended permanently effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 repealed and new Regulations .01<MD.16 adopted effective November 15, 2010 (37:23 Md. R. 1609)</annotation> </annotations> </chapter> <chapter num="06" heading="Foreign-Educated Licensure Requirements"> <regulation prefix="Regulation" num=".01" heading="Requirements for Licensure."> <paragraph num="A."> <text>Application Options.</text> <paragraph num="(1)"> <text>An applicant educated in a physical therapy core curriculum outside the United States or its territories shall apply for licensure under one of the categories described in §A(2)—(4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Examination. The applicant shall file with the Board:</text> <paragraph num="(a)"> <text>An application on the form the Board provides;</text> </paragraph> <paragraph num="(b)"> <text>The application and examination fees as specified in COMAR 10.38.07;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of educational credentials forwarded directly to the Board from an approved agency that provides evidence that the applicant's education is equivalent to that of an accredited core physical therapy program in the United States;</text> </paragraph> <paragraph num="(d)"> <text>Evidence of oral competency in the English language; and</text> </paragraph> <paragraph num="(e)"> <text>Evidence of written competency in the English language.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Transfer of Examination Scores. The applicant shall file the following with the Board:</text> <paragraph num="(a)"> <text>An application on the form the Board provides;</text> </paragraph> <paragraph num="(b)"> <text>The application fee as specified in COMAR 10.38.07;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of educational credentials forwarded directly to the Board from an approved agency that provides evidence that the applicant's education is equivalent to that of an accredited physical therapy program in the United States;</text> </paragraph> <paragraph num="(d)"> <text>Evidence of oral competency in the English language;</text> </paragraph> <paragraph num="(e)"> <text>Evidence of written competency in the English language;</text> </paragraph> <paragraph num="(f)"> <text>A sworn statement that the applicant is not licensed in another state;</text> </paragraph> <paragraph num="(g)"> <text>Evidence, satisfactory to the Board, that the applicant is registered to take, or has taken, the national licensing examination in another state; and</text> </paragraph> <paragraph num="(h)"> <text>A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Waiver of Examination. The applicant shall file the following with the Board:</text> <paragraph num="(a)"> <text>An application on the form the Board provides;</text> </paragraph> <paragraph num="(b)"> <text>The application fee as specified in COMAR 10.38.07;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of educational credentials forwarded directly to the Board from an approved agency that provides evidence that the applicant's education is equivalent to that of an accredited core physical therapy program in the United States;</text> </paragraph> <paragraph num="(d)"> <text>Evidence of oral competency in the English language;</text> </paragraph> <paragraph num="(e)"> <text>Evidence of written competency in the English language;</text> </paragraph> <paragraph num="(f)"> <text>A copy of a current physical therapy license;</text> </paragraph> <paragraph num="(g)"> <text>Verification of current licensure on the form the Board provides; and</text> </paragraph> <paragraph num="(h)"> <text>A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, an applicant educated in a core physical therapy curriculum outside the United States or its territories shall comply with §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>Additional Requirements. Applicants for licensure shall:</text> <paragraph num="(1)"> <text>Achieve a passing score on the licensing examinations;</text> </paragraph> <paragraph num="(2)"> <text>Attend an interview unless the Board waives this requirement; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13–302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Reexamination."> <paragraph num="A."> <text>National Licensing Examination.</text> <paragraph num="(1)"> <text>An applicant who fails shall repeat the examination.</text> </paragraph> <paragraph num="(2)"> <text>Fees.</text> <paragraph num="(a)"> <text>The applicant shall pay to the Board the reexamination fee as specified in COMAR 10.38.07.</text> </paragraph> <paragraph num="(b)"> <text>An applicant who fails the licensing examination twice shall pay to the Board an application fee as specified in COMAR 10.38.07 in addition to the reexamination fee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Examination on Maryland Physical Therapy Law. An applicant who fails the examination on the Maryland Physical Therapy Practice Act and associated regulations shall:</text> <paragraph num="(1)"> <text>Repeat the examination; and</text> </paragraph> <paragraph num="(2)"> <text>Attend an interview unless the Board waives this requirement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Issuance of Licenses."> <paragraph num="A."> <text>Temporary License.</text> <paragraph num="(1)"> <text>The Board may issue a temporary license to an applicant who, except for passing an examination otherwise required under Health Occupations Article, Title 13, Annotated Code of Maryland, has met the appropriate education and experience requirements for a physical therapy license or a physical therapist assistant license set forth under Health Occupations Article, §13-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The holder of a temporary license shall:</text> <paragraph num="(a)"> <text>Practice under direct supervision while the temporary license is in effect;</text> </paragraph> <paragraph num="(b)"> <text>Achieve a passing score on the Maryland Physical Therapy jurisprudence exam; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13-302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A temporary license is valid until:</text> <paragraph num="(a)"> <text>90 days after issuance;</text> </paragraph> <paragraph num="(b)"> <text>The Board issues a full license to practice physical therapy or limited physical therapy to the holder of the temporary license; or</text> </paragraph> <paragraph num="(c)"> <text>The Board revokes the temporary license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure Procedures.</text> <paragraph num="(1)"> <text>When the applicant has met all the requirements for licensure, the Board may issue a physical therapist license to the applicant.</text> </paragraph> <paragraph num="(2)"> <text>Renewal of Physical Therapist License.</text> <paragraph num="(a)"> <text>The licensee shall renew the physical therapist license biennially.</text> </paragraph> <paragraph num="(b)"> <text>The licensee shall be responsible for notifying the Board if a renewal notice is not received.</text> </paragraph> <paragraph num="(c)"> <text>The Board may issue a renewal license to the licensee who meets the requirements of Health Occupations Article, §13-311(c), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Method of Renewal Notification.</text> <paragraph num="(a)"> <text>Except as otherwise provided in §B(3)(b) of this regulation, the Board shall mail notices for renewal at least 1 month before the expiration date.</text> </paragraph> <paragraph num="(b)"> <text>If requested by a licensee, the Board shall send to the licensee, at least two times within the month before a license expires, a renewal notice by electronic means to the last known electronic mail address of the licensee.</text> </paragraph> <paragraph num="(c)"> <text>If a renewal notice sent by electronic mail under §B(3)(b) of this regulation is returned to the Board as undeliverable, the Board shall send to the licensee a renewal notice by first-class mail to the last known address of the licensee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may issue a duplicate license for a lost, stolen, or destroyed license provided the licensee:</text> <paragraph num="(a)"> <text>Makes a request in writing;</text> </paragraph> <paragraph num="(b)"> <text>Provides a sworn statement or police report attesting to the facts; and</text> </paragraph> <paragraph num="(c)"> <text>Pays the fee as established in COMAR 10.38.07.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Board may not issue a license under this subtitle if the results of the criminal history records check required pursuant to Regulation .01C(3) of this chapter has not been received.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Restrictions."> <paragraph num="A."> <text>The Board may refuse to grant a license to an applicant who:</text> <paragraph num="(1)"> <text>Begins practice as a physical therapist before being licensed to practice in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Practices after the date of expiration of the license;</text> </paragraph> <paragraph num="(3)"> <text>Fails the licensing examinations; or</text> </paragraph> <paragraph num="(4)"> <text>Fails to pay all outstanding fees to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant shall complete the application process within 1 year of the date of the paid application or reapply for licensure.</text> </paragraph> <paragraph num="C."> <text>The Board may refuse to renew a license of an applicant who fails to pay all outstanding fees to the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§13-206, 13-207, 13-301—13-303, 13-305—13-307, and 13-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 29, 1986 (13:26 Md. R. 2807)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B—D amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective August 5, 1991 (18:15 Md. R. 1727); December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 17, 2000 (27:7 Md. R. 706); April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, B amended effective February 25, 2008 (35:4 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective April 16, 2001 (28:7 Md. R. 690); June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 17, 2000 (27:7 Md. R. 706)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 17, 2000 (27:7 Md. R. 706); April 6, 2009 (36:7 Md. R. 525); April 2, 2012 (39:6 Md. R. 408); April 4, 2022 (49:7 Md. R. 466)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 17, 2000 (27:7 Md. R. 706); April 24, 2006 (33:8 Md. R. 734)</annotation> </annotations> </chapter> <chapter num="07" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all persons licensed or applying for licensure by the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>The following fees are established by the Board:</text> <paragraph num="(1)"> <text>Application fee — $150;</text> </paragraph> <paragraph num="(2)"> <text>Biennial renewal fee:</text> <paragraph num="(a)"> <text>Physical therapist — $325;</text> </paragraph> <paragraph num="(b)"> <text>Physical therapist assistant — $300;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Reinstatement fee — $400;</text> </paragraph> <paragraph num="(4)"> <text>Restricted license — $125;</text> </paragraph> <paragraph num="(5)"> <text>Duplicate license — $75;</text> </paragraph> <paragraph num="(6)"> <text>Penalty for returned check — $40;</text> </paragraph> <paragraph num="(7)"> <text>Written verification of licensure — $25;</text> </paragraph> <paragraph num="(8)"> <text>Review of course CE hours for licensee — $25;</text> </paragraph> <paragraph num="(9)"> <text>Approval for CE hours to course provider — $100;</text> </paragraph> <paragraph num="(10)"> <text>Penalty for failure to maintain correct address with the Board — $100;</text> </paragraph> <paragraph num="(11)"> <text>Interstate physical therapy licensure compact fee — $125; and</text> </paragraph> <paragraph num="(12)"> <text>Dry needling one-time registration fee — $100.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Federation of State Boards of Physical Therapy determines the fees for the National Licensure Examination and the Maryland Jurisprudence Assessment for physical therapists and physical therapist assistants.</text> </paragraph> <paragraph num="C."> <text>The Maryland Health Care Commission (MHCC) assesses a fee for health care professionals which the applicant shall pay at the time of license renewal as specified in COMAR 10.25.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Refunds."> <text>Fees paid to the Board are nonrefundable.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Physical Therapy Examiners. The Board shall notify licensees and applicants of changes.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§13-206, 13-207, and 13-3A-01(3)(d)(2), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 29, 1986 (13:26 Md. R. 2808)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 2, 1992 (19:4 Md. R. 474); January 1, 1996 (22:26 Md. R. 2030)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective August 5, 1992 (19:17 Md. R. 1605); amended permanently effective November 23, 1992 (19:23 Md. R. 2041)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 2, 1992 (19:4 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 15, 1997 (24:25 Md. R. 1719)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 16, 2001 (28:7 Md. R. 690)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective December 7, 2001 (29:3 Md. R. 213); amended permanently effective April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 24, 2006 (33:8 Md. R. 734); June 14, 2021 (48:12 Md. R. 474); August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 18, 2025 (52:16 Md. R. 846)</annotation> </annotations> </chapter> <chapter num="08" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs:</text> <paragraph num="A."> <text>A licensee applying for renewal;</text> </paragraph> <paragraph num="B."> <text>An individual applying for reinstatement of licensure; and</text> </paragraph> <paragraph num="C."> <text>Providers of continuing education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“APTA” means the American Physical Therapy Association and its:</text> <paragraph num="(a)"> <text>Academies;</text> </paragraph> <paragraph num="(b)"> <text>Sections; and</text> </paragraph> <paragraph num="(c)"> <text>State chapters.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CE Hour.</text> <paragraph num="(a)"> <text>“CE hour” means a period of 60 minutes in which the licensee is engaged in a learning activity.</text> </paragraph> <paragraph num="(b)"> <text>“CE hour” does not include any portion of continuing education devoted to registration, breaks, social networking, or meals.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Continuing education (CE)” means learning experiences that:</text> <paragraph num="(a)"> <text>Include a licensee’s direct participation; and</text> </paragraph> <paragraph num="(b)"> <text>Are designed to enhance the professional practice of physical therapy and limited physical therapy.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Provider” means an individual or group who designs and develops CE activities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Continuing Education Requirements."> <paragraph num="A."> <text>Continuing education is a requirement for renewal or reinstatement of licenses for physical therapists and physical therapist assistants, which may be obtained by:</text> <paragraph num="(1)"> <text>Postgraduate studies which include academic and professional studies that enhance competencies or instill new knowledge or skills, or both;</text> </paragraph> <paragraph num="(2)"> <text>Attendance at or presentation of seminars, conferences, courses, or workshops;</text> </paragraph> <paragraph num="(3)"> <text>Authoring, co-authoring, or editing of a book, book chapter, peer-reviewed journal article, or abstract;</text> </paragraph> <paragraph num="(4)"> <text>Home or self-directed study;</text> </paragraph> <paragraph num="(5)"> <text>Research;</text> </paragraph> <paragraph num="(6)"> <text>Workplace and community service contributions, and leadership relevant to the development of personal and professional competence; or</text> </paragraph> <paragraph num="(7)"> <text>Supervision of physical therapists or physical therapist assistant students in a clinical rotation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Continuing education eligible for CE hours shall:</text> <paragraph num="(1)"> <text>Be relevant to the professional practice of physical therapy;</text> </paragraph> <paragraph num="(2)"> <text>Be directed to a professional audience; and</text> </paragraph> <paragraph num="(3)"> <text>Promote continuous professional development.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall have final approval of the relevancy of the continuing education.</text> </paragraph> <paragraph num="D."> <text>Continuing education shall have clear and concise written statements of:</text> <paragraph num="(1)"> <text>Learning outcomes; or</text> </paragraph> <paragraph num="(2)"> <text>Instructional objectives.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Continuing education offered by the following organizations is automatically approved by the Board:</text> <paragraph num="(1)"> <text>APTA; and</text> </paragraph> <paragraph num="(2)"> <text>The Federation of State Boards of Physical Therapy (FSBPT).</text> </paragraph> </paragraph> <paragraph num="F."> <text>Continuing education approved by APTA is automatically accepted by the Board</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Continuing Education Course Approval."> <paragraph num="A."> <text>To obtain approval of continuing education, a provider shall submit the following information to the Board 6 weeks before the activity commencement date:</text> <paragraph num="(1)"> <text>An application on a Board-approved application form, accompanied by any required fee set forth in COMAR 10.38.07.02;</text> </paragraph> <paragraph num="(2)"> <text>A complete hour-by-hour agenda of the CE;</text> </paragraph> <paragraph num="(3)"> <text>A clear and concise written statement describing the CE’s:</text> <paragraph num="(a)"> <text>Learning outcomes; or</text> </paragraph> <paragraph num="(b)"> <text>Instructional objectives;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Curriculum vitae for each instructor describing the instructor’s competence in the CE subject matter and skill in instructional methodologies; and</text> </paragraph> <paragraph num="(5)"> <text>If an instructor is not licensed by the Board or does not hold a Maryland compact privilege and plans to perform physical therapy in conjunction with the CE, an application for a restricted license obtained from the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Public Representations.</text> <paragraph num="(1)"> <text>If the CE is approved by the Board, the Board shall notify the provider of the approval, including the number of approved CE hours.</text> </paragraph> <paragraph num="(2)"> <text>If a provider receives notification under §B(1) of this regulation, the provider may represent that the CE has been approved by the Board.</text> </paragraph> <paragraph num="(3)"> <text>Approved CE certificates and advertisements shall contain the following statement: “This continuing education has been approved by the Maryland State Board of Physical Therapy Examiners for ______ CE hours.”</text> </paragraph> <paragraph num="(4)"> <text>A record of CE attendees shall be retained by the provider for at least 4 years.</text> </paragraph> <paragraph num="(5)"> <text>The provider shall submit to the Board for approval any CE changes, such as changes in:</text> <paragraph num="(a)"> <text>Instructor;</text> </paragraph> <paragraph num="(b)"> <text>Agenda;</text> </paragraph> <paragraph num="(c)"> <text>Content;</text> </paragraph> <paragraph num="(d)"> <text>Learning outcomes;</text> </paragraph> <paragraph num="(e)"> <text>Instructional objectives; or</text> </paragraph> <paragraph num="(f)"> <text>Length.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Term of Approval.</text> <paragraph num="(1)"> <text>The Board shall approve the CE for a period of 4 years.</text> </paragraph> <paragraph num="(2)"> <text>At the expiration of the 4-year approval period, the provider:</text> <paragraph num="(a)"> <text>May resubmit the CE; and</text> </paragraph> <paragraph num="(b)"> <text>Shall meet the approval requirements of §A of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee may submit a request for review of continuing education from the Board if the:</text> <paragraph num="(1)"> <text>Continuing education is not already approved or disapproved by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Licensee submits a request to the Board at least 30 days prior to the commencement of the CE activity containing, but not exclusive to, information set forth in Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may request payment of a continuing education review as set forth in COMAR 10.38.07.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewal Requirements."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Earn CE hours between June 1 and May 31 during the 2-year period before renewal; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain records of the CE subject matter, certificates of completion, hours, date, and CE hours to present to the Board on request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CE hours completed after May 31 of the year of the renewal may not be accepted.</text> </paragraph> <paragraph num="C."> <text>All renewal applications shall be accompanied by a continuing education form to be completed by the licensee.</text> </paragraph> <paragraph num="D."> <text>A physical therapist shall earn 30 CE hours for the renewal period.</text> </paragraph> <paragraph num="E."> <text>A physical therapist assistant shall earn 20 CE hours for the renewal period.</text> </paragraph> <paragraph num="F."> <text>CE hours may not be carried over from one renewal period to the next.</text> </paragraph> <paragraph num="G."> <text>Failure to substantiate CE hours if requested by the Board shall result in denial of license renewal or reinstatement of a license.</text> </paragraph> <paragraph num="H."> <text>If the licensee has met all the requirements for renewal, the Board may renew a license for the first renewal period following the issuance of the original license without requiring the physical therapist or physical therapist assistant to complete any CE hours if, at the time of renewal, the original license was issued 1 year or less before the renewal period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Auditing Compliance with Continuing Education Requirements."> <paragraph num="A."> <text>The Board shall audit the continuing education records of as many licensees as time and resources allow.</text> </paragraph> <paragraph num="B."> <text>The Board shall send an audit letter to those to be audited at the close of the renewal period.</text> </paragraph> <paragraph num="C."> <text>At the time of audit, the audited licensees shall submit documentation relating to compliance with CE requirements as set forth in this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board may request from the licensee evidence of achieving the CE hours.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Reinstatement Requirements."> <paragraph num="A."> <text>A physical therapist shall earn 30 CE hours in the 2-year period immediately preceding reinstatement.</text> </paragraph> <paragraph num="B."> <text>A physical therapist assistant shall earn 20 CE hours in the 2-year period immediately preceding reins.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Continuing Education Professional Development Criteria."> <text>CE activities meeting the criteria for continuing education requirements for the practice of physical therapy may include:</text> <paragraph num="A."> <text>Postgraduate academic course work in physical therapy taken at an accredited college or university, which may earn 10 CE hours per course credit;</text> </paragraph> <paragraph num="B."> <text>Attendance at Board-approved or APTA-approved continuing education, which may earn 1 CE hour for every approved hour;</text> </paragraph> <paragraph num="C."> <text>Presentation of continuing education, which may earn 2 CE hours for every hour of presentation with presentations of the same subject matter receiving CE hours only once in a renewal period;</text> </paragraph> <paragraph num="D."> <text>Authoring, co-authoring, or editing of a book, book chapter, or peer- reviewed journal article, which may earn 30 CE hours with proof accompanying the request for approval;</text> </paragraph> <paragraph num="E."> <text>Authoring an abstract, which may earn 10 CE hours;</text> </paragraph> <paragraph num="F."> <text>Completion of an approved self-directed study course, which may earn 1 CE hour per interactive hour;</text> </paragraph> <paragraph num="G."> <text>Completion of an approved home study course, which may earn 1 CE hour per interactive hour;</text> </paragraph> <paragraph num="H."> <text>Completion of continuing education relevant to workplace and community service contributions, and leadership relevant to the development of personal and professional competence, which may earn 1 CE hour only once in a renewal period;</text> </paragraph> <paragraph num="I."> <text>Supervision of physical therapists or physical therapist assistant students in a clinical rotation, which may earn 10 CE hours only once in a renewal period (1 CE hour equals 40 hours of supervision); or</text> </paragraph> <paragraph num="J."> <text>Research, which may earn 10 CE hours.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">: Health Occupations Article, §§13-206 and 13-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 9, 1991 (18:24 Md. R. 2644)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .03 repealed and new Regulations .01 — .03 adopted effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I amended effective July 12, 1999 (26:14 Md. R. 1083)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.08 adopted effective March 18, 2002 (29:5 Md. R. 504)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, D amended effective February 25, 2008 (35:4 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective February 25, 2008 (35:4 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 25, 2008 (35:4 Md. R. 515); November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective August 18, 2025 (52:16 Md. R. 846)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective February 25, 2008 (35:4 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, D amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, F amended effective February 25, 2008 (35:4 Md. R. 515)</annotation> </annotations> </chapter> <chapter num="09" heading="Speech-Impaired Applicants"> <regulation prefix="Regulation" num=".01" heading="Speech-Impaired Applicants."> <paragraph num="A."> <text>An applicant who claims a speech impairment shall fulfill all requirements for application and shall submit to the Board the following:</text> <paragraph num="(1)"> <text>Documentation of the applicant's impairment from an otolaryngologist, who has current certification from the American Board of Otolaryngology; and</text> </paragraph> <paragraph num="(2)"> <text>Documentation of the applicant's impairment from a speech-language pathologist who has current certification from the American Speech-Language Hearing Association.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall require the speech-impaired applicant to prove ability to communicate adequately with patients and other health care professionals. The proof of ability to communicate shall include:</text> <paragraph num="(1)"> <text>Three letters from supervising physical therapists or instructors in a physical therapy program, attesting to the applicant's ability to communicate in a professionally competent manner; and</text> </paragraph> <paragraph num="(2)"> <text>A meeting before the Board where the applicant shall be required to demonstrate the manner in which communication with patients will occur.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A speech-language pathologist or otolaryngologist may be asked to attend the meeting in an advisory capacity to the Board to aid in assessing the applicant's ability to communicate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Requirements."> <paragraph num="A."> <text>A foreign-trained speech-impaired applicant shall notify the Board before taking a Board-approved standardized test of oral competency.</text> </paragraph> <paragraph num="B."> <text>The Board shall attempt to locate a speech-language pathologist fluent in the applicant's native language to assess the impairment.</text> </paragraph> <paragraph num="C."> <text>A foreign-trained applicant who is in need of foreign accent reduction, but has competency in his or her native language, may obtain assistance from a bilingual speech-language pathologist before attempting to pass the test of spoken English.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§13-206 and 13-302(e)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 7, 1992 (19:24 Md. R. 2126)</annotation> </annotations> </chapter> <chapter num="10" heading="Disciplinary Sanctions, Monetary Penalties, and Civil Fines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of disciplinary sanctions, monetary penalties, and civil fines for violations of the Maryland Physical Therapy Act.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means the Maryland Physical Therapy Act, Health Occupations Article, Title 13, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Civil fine” means a fine assessed by the Board against an individual for practicing physical therapy or limited physical therapy without a license.</text> </paragraph> <paragraph num="(4)"> <text>“License” means a license issued by the Board to practice physical therapy or limited physical therapy.</text> </paragraph> <paragraph num="(5)"> <text>“Licensee” means a physical therapist or physical therapist assistant who is licensed by the Board to practice physical therapy or limited physical therapy.</text> </paragraph> <paragraph num="(6)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(7)"> <text>“Sanction” means a disciplinary action reprimanding, restricting, suspending, or revoking a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty — General."> <text>Imposition of a Penalty after a Hearing. If the Board finds that there are grounds under Health Occupations Article, §13-316, Annotated Code of Maryland, to reprimand a licensee or suspend or revoke a license, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="A."> <text>Instead, of, or in addition to, reprimanding the licensee or suspending the license; or</text> </paragraph> <paragraph num="B."> <text>In addition to revoking the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties."> <paragraph num="A."> <text>Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this regulation, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or a consent order with terms, sanction, and penalty agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="D."> <text>A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="E."> <text>The Board may not consider a petition for reinstatement of a license that has been revoked until at least 3 years have passed from the date of revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to be Considered in the Assessment of the Sanction and Penalty."> <paragraph num="A."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider, but not be limited to, the mitigating and aggravating factors outlined in §§B and C of this regulation in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines.</text> </paragraph> <paragraph num="B."> <text>Mitigating Factors. The Board may consider the following mitigating factors:</text> <paragraph num="(1)"> <text>The licensee’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The licensee self-reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The licensee’s full and voluntary admission of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>The licensee implemented remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee made timely good-faith effort to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm to the public or adverse impact; and</text> </paragraph> <paragraph num="(9)"> <text>The licensee’s conduct was an isolated incident and not likely to recur.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Aggravating Factors. The Board may consider the following aggravating factors:</text> <paragraph num="(1)"> <text>The licensee has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the patient or patients;</text> </paragraph> <paragraph num="(7)"> <text>The licensee attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(8)"> <text>Previous attempts at rehabilitation of the licensee were unsuccessful; and</text> </paragraph> <paragraph num="(9)"> <text>The licensee committed the violation under the guise of treatment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="E."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Civil Fines."> <paragraph num="A."> <text>Practicing on an Expired License. The Board may assess a civil fine against a physical therapist or physical therapist assistant who practices physical therapy or limited physical therapy on an expired license in the amount of $100 per day of practice past the expiration date of the license.</text> </paragraph> <paragraph num="B."> <text>Practicing Without a License.</text> <paragraph num="(1)"> <text>The Board may assess a civil fine of no less than $5,000 and no more than $50,000 against an individual who practices physical therapy or limited physical therapy without a license.</text> </paragraph> <paragraph num="(2)"> <text>Factors in determining the amount of a fine include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The extent to which the individual derived any financial benefit from the unauthorized practice;</text> </paragraph> <paragraph num="(b)"> <text>The willfulness of the unauthorized practice;</text> </paragraph> <paragraph num="(c)"> <text>Actual or potential public harm caused by the unauthorized practice; and</text> </paragraph> <paragraph num="(d)"> <text>The length of time in which the individual engaged in the unauthorized practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment of a Penalty."> <paragraph num="A."> <text>Unless the Board specifies otherwise, a licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §13-318, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board pursuant to this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board pursuant to this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>Deposit of Monies.</text> <paragraph num="(1)"> <text>The Board shall pay all monies collected pursuant to this chapter, except for civil fines collected under Regulation .06 of this chapter, into the State's General Fund.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall pay all civil fines collected under Regulation .06 of this chapter into the State Board of Physical Therapy Examiners Fund, in accordance with Health Occupations Article, §13-407(b)(2), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §1-606, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 15, 2000 (27:9 Md. R. 858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective April 16, 2001 (28:7 Md. R. 690); April 6, 2009 (36:7 Md. R. 525)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 under chapter, Monetary Penalties repealed and new Regulations .01—.07 under chapter Disciplinary Sanctions, Monetary Penalties, and Civil Fines adopted effective January 23, 2012 (39:1 Md. R. 18)</annotation> </annotations> </chapter> <chapter num="11" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter does not apply to the disclosure of information in the Board's files to a health occupations regulatory board of this State or another state that licenses or disciplines persons practicing a health occupation.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>A custodian of the Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, and may disclose information concerning competent evidence of:</text> <paragraph num="A."> <text>Possible criminal activity, if disclosure is to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, if disclosure is to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, if disclosure is to a law enforcement authority, administrative official, agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prohibit or limit the ability of the Board to disclose general licensing information under General Provisions Article, §4-333, Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333;Health Occupations Article, §13-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 11, 2002 (29:22 Md. R. 1721)</annotation> </annotations> </chapter> <chapter num="12" heading="Dry Needling"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the provision of dry needling as an intervention performed by physical therapists.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Dry needling” means a physical therapy intervention, also known as intramuscular manual therapy, that:</text> <paragraph num="(a)"> <text>Involves the insertion of one or more solid needles, a mechanical device, into the muscle and related tissues to affect change in muscle and related tissues;</text> </paragraph> <paragraph num="(b)"> <text>Requires ongoing evaluation, assessment, and re-evaluation of the impairments;</text> </paragraph> <paragraph num="(c)"> <text>Is only utilized in parts of the body with neuromuscular or musculoskeletal links to the impairments; and</text> </paragraph> <paragraph num="(d)"> <text>Is not performed for:</text> <paragraph num="(i)"> <text>The purposes of acupuncture as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Any purpose outside the scope of physical therapy.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Minimum Education and Training Necessary to Perform Dry Needling."> <paragraph num="A."> <text>In order to perform dry needling, a physical therapist shall have at least 80 total hours of instruction, which includes:</text> <paragraph num="(1)"> <text>A total of at least 40 hours of instruction in the following dry needling-specific course content areas:</text> <paragraph num="(a)"> <text>Theory and application of dry needling;</text> </paragraph> <paragraph num="(b)"> <text>Dry needling technique, including spine and extremities;</text> </paragraph> <paragraph num="(c)"> <text>Dry needling indications and contraindications;</text> </paragraph> <paragraph num="(d)"> <text>Infection control, the Occupational Safety and Health Administration’s Bloodborne Pathogen Protocol, and safe handling of needles;</text> </paragraph> <paragraph num="(e)"> <text>Emergency preparedness and response procedures related to complications associated with dry needling; and</text> </paragraph> <paragraph num="(f)"> <text>Appropriate documentation of dry needling; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 40 hours of practical, hands-on instruction in the application and technique of dry needling, under the supervision of a licensed health care practitioner competent in dry needling procedures who has:</text> <paragraph num="(a)"> <text>Completed the requisite course work under §A(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Practiced dry needling for at least 5 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The instruction required under §A(1) of this regulation shall be provided by a continuing education course sponsored by the:</text> <paragraph num="(1)"> <text>American Physical Therapy Association;</text> </paragraph> <paragraph num="(2)"> <text>The APTA of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>The Federation of State Boards of Physical Therapy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A continuing education course taken before June 19, 2018 shall qualify for instruction if the same course, in substantially similar form, is later sponsored by the American Physical Therapy Association, the APTA of Maryland, or the Federation of State Boards of Physical Therapy.</text> </paragraph> <paragraph num="D."> <text>All instruction required under this regulation shall include an assessment of competency.</text> </paragraph> <paragraph num="E."> <text>The instruction required under §A(1) of this regulation shall be offered:</text> <paragraph num="(1)"> <text>In person at a face-to-face session; or</text> </paragraph> <paragraph num="(2)"> <text>In real time through electronic means that allow for simultaneous interaction between the instructor and the participants.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A physical therapist may not fulfill any portion of the practical, hands-on instruction required under §A(2) of this regulation with online or distance learning.</text> </paragraph> <paragraph num="G."> <text>A physical therapist shall have practiced physical therapy for at least 2 years before performing dry needling in the State.</text> </paragraph> <paragraph num="H."> <text>Registration.</text> <paragraph num="(1)"> <text>A physical therapist shall be registered with the Board as having the appropriate education and training required by this regulation before the physical therapist may practice dry needling.</text> </paragraph> <paragraph num="(2)"> <text>In order to be registered to practice dry needling, a physical therapist shall:</text> <paragraph num="(a)"> <text>Submit a completed application on a form supplied by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Pay a registration fee as established by COMAR 10.38.07.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A physical therapist who practices dry needling without the education and training required by this regulation shall be subject to discipline pursuant to COMAR 10.38.10.04A(4).</text> </paragraph> <paragraph num="J."> <text>This regulation shall take effect October 1, 2018.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice in Performing Dry Needling."> <paragraph num="A."> <text>A physical therapist shall:</text> <paragraph num="(1)"> <text>Fully explain dry needling to the patient in advance of treatment; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain written informed consent specific to dry needling that shall be included in the patient’s medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A physical therapist shall perform dry needling in a manner consistent with standards set forth in the Maryland Occupational Safety and Health Act, Labor and Employment Article, Title 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A physical therapist shall document the provision of dry needling services in accordance with the documentation requirements of COMAR 10.38.03.02-1.</text> </paragraph> <paragraph num="D."> <text>A physical therapist who practices dry needling in a manner inconsistent with the standards of practice enumerated in this regulation shall be subject to discipline pursuant to COMAR 10.38.10.04A(14).</text> </paragraph> <paragraph num="E."> <text>Dry needling is not within the scope of practice of limited physical therapy and shall only be performed by a licensed physical therapist.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §13-101 and 13-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 2017 (44:12 Md. R. 588)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J amended effective August 27, 2018 (45:17 Md. R. 804)</annotation> </annotations> </chapter> <chapter num="13" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of physical therapy or limited physical therapy using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in these regulations restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Physical Therapy Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means:</text> <paragraph num="(a)"> <text>A Maryland licensed physical therapist or physical therapist assistant performing telehealth services within their respective scope of practice; or</text> </paragraph> <paragraph num="(b)"> <text>A physical therapist or physical therapist assistant with a compact privilege in Maryland performing telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, §13-301, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland or hold a compact privilege in Maryland when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before providing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license number and type or compact privilege number, if applicable, and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of the recommended treatment plan;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self–reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the patient’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person physical therapy practice appointments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>A physical therapist who practices telehealth shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing a treatment plan through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a telehealth practitioner who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 795)</annotation> </annotations> </chapter> </subtitle> <subtitle num="39" heading="Board of Nursing — Certificate Holders"> <chapter num="01" heading="Certified Nursing Assistants"> <regulation prefix="Regulation" num=".01" heading="Exceptions."> <text>This chapter does not apply to an individual who:</text> <paragraph num="A."> <text>Other than a certified nursing assistant, practices a health occupation, that the individual is authorized to practice under the Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Provides for the gratuitous care of friends, domestic partners, or family members;</text> </paragraph> <paragraph num="C."> <text>Performs nursing assistant tasks while a nursing student enrolled in an accredited nursing program if the individual either:</text> <paragraph num="(1)"> <text>Is practicing under the direct supervision of qualified faculty or preceptors; or</text> </paragraph> <paragraph num="(2)"> <text>Successfully completed the portion of the approved nursing education program that the Board determines meets the requirements of an approved nursing assistant training program as described in Regulation .05D of this chapter;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Performs nursing assistant tasks:</text> <paragraph num="(1)"> <text>While a student enrolled in an approved nursing assistant training program or approved acute care nursing assistant training program; and</text> </paragraph> <paragraph num="(2)"> <text>While practicing under the direct supervision of qualified faculty or preceptors;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Practices as a certified nursing assistant-I for less than 4 months in accordance with 42 CFR §483.35(d);</text> </paragraph> <paragraph num="F."> <text>Performs nursing tasks delegated by a registered nurse or licensed practical nurse so long as the delegated nursing tasks do not become a routine part of the individual's job duties;</text> </paragraph> <paragraph num="G."> <text>Performs nursing tasks delegated by an advanced practice registered nurse in accordance with Health Occupations Article, §8-6A-02(d), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="H."> <text>Performs technical tasks delegated by a licensed certified midwife in accordance with Health Occupations Article, §8-6A-02(e), Annotated Code of Maryland.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute care nursing assistant training program” means a course of training that meets the acute care nursing assistant training program curriculum approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Central Repository” means the Maryland Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(4)"> <text>“Certificate” means a certificate issued by the Board to practice as a certified nursing assistant in the State.</text> </paragraph> <paragraph num="(5)"> <text>Certified Nursing Assistant (CNA).</text> <paragraph num="(a)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who, for compensation and subject to regulations adopted by the Board, routinely performs:</text> <paragraph num="(i)"> <text>Nursing tasks delegated by a registered nurse, licensed practical nurse, or advanced practice registered nurse; or</text> </paragraph> <paragraph num="(ii)"> <text>Technical tasks delegated by a licensed certified midwife.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant (CNA)” does not include dialysis technician or medication technician.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Certified Nursing Assistant-I (CNA-I).</text> <paragraph num="(a)"> <text>“Certified nursing assistant-I (CNA-I)” means a CNA who:</text> <paragraph num="(i)"> <text>Meets the requirements set by the Board and federal law; and</text> </paragraph> <paragraph num="(ii)"> <text>May practice in any practice setting.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant-I (CNA-I)” includes a:</text> <paragraph num="(i)"> <text>CNA who was certified as a geriatric nursing assistant on March 31, 2026;</text> </paragraph> <paragraph num="(ii)"> <text>Certified medicine aide; and</text> </paragraph> <paragraph num="(iii)"> <text>CNA who is certified under Health Occupations Article, §8-6A-05(c)(5), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certified nursing assistant-II (CNA-II)” means a CNA who:</text> <paragraph num="(a)"> <text>On March 31, 2026, was certified as a CNA but not certified as a geriatric nursing assistant; and</text> </paragraph> <paragraph num="(b)"> <text>May not practice in a nursing facility or skilled nursing facility.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Criminal history records check (CHRC)” means the performance of both a State criminal history records check by the Central Repository and a national criminal history records check performed by the Federal Bureau of Investigation (FBI).</text> </paragraph> <paragraph num="(9)"> <text>“Criminal history record information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, and convictions and other dispositions of criminal charges.</text> </paragraph> <paragraph num="(10)"> <text>“Good standing” means without an encumbrance that limits or restricts practice, such as revocation, suspension, or probation.</text> </paragraph> <paragraph num="(11)"> <text>“Nursing assistant competency evaluation” means an examination approved by the Board that:</text> <paragraph num="(a)"> <text>Determines the competency of the individual to practice as a CNA-I; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements under federal law.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Nursing assistant training program” means a course of training approved by the Board that meets the requirements under federal and State law.</text> </paragraph> <paragraph num="(13)"> <text>“Service member” has the meaning stated in State Government Article, §9-901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Temporary nurse aide” means an individual who practiced as a geriatric nursing assistant without certification during the national Coronavirus Disease 2019 (COVID-19) Public Health Emergency, as declared on January 31, 2020, and periodically continued by the United States Secretary of Health and Human Services, pursuant to the waiver of the requirements of 42 CFR §483.35(d) issued by the Centers for Medicare and Medicaid Services on March 6, 2020.</text> </paragraph> <paragraph num="(15)"> <text>“Technical task” means a routine clinical act or task that does not require clinical judgment and is performed with the supervision as specified in COMAR 10.69.02.</text> </paragraph> <paragraph num="(16)"> <text>“Temporary nurse aide training” means an 8-hour online training and examination program offered by:</text> <paragraph num="(a)"> <text>The American Health Care Association;</text> </paragraph> <paragraph num="(b)"> <text>The National Center for Assisted Living; or</text> </paragraph> <paragraph num="(c)"> <text>Another comparable program approved by the Board.</text> </paragraph> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".03" heading="Fees."> <paragraph num="A."> <text>Fees are as follows:</text> <paragraph num="(1)"> <text>Initial certification fee — $20;</text> </paragraph> <paragraph num="(2)"> <text>Endorsement fee — $20;</text> </paragraph> <paragraph num="(3)"> <text>Renewal fee — $40;</text> </paragraph> <paragraph num="(4)"> <text>Verification of certification to another jurisdiction — $25;</text> </paragraph> <paragraph num="(5)"> <text>Returned check fee — $25;</text> </paragraph> <paragraph num="(6)"> <text>Duplicate certificate fee — $10.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fees are not refundable.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".04" heading="General Provisions for Applications."> <paragraph num="A."> <text>An applicant shall submit:</text> <paragraph num="(1)"> <text>A completed application to the Board on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>To a CHRC in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Written evidence satisfactory to the Board that the applicant has submitted to a CHRC as required by §A(2) of this regulation by submitting:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the FBI;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>Under §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>In an answer to a question on the Board’s application form; or</text> </paragraph> <paragraph num="(c)"> <text>From any other source; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) of this regulation is incomplete or insufficient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to complete the application and provide all information and documents required in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board under §A of this regulation within 12 months from the date the application is received by the Board, then the application shall be considered abandoned and may be destroyed.</text> </paragraph> <paragraph num="D."> <text>Once an application is deemed abandoned under §C of this regulation, an individual seeking CNA certification shall submit a new application on the form required by the Board and meet all of the requirements for CNA certification and pay the required fees that are in effect at the time of re-application.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications for Certification."> <paragraph num="A."> <text>Initial Certification. An applicant for initial nursing assistant certification shall have successfully:</text> <paragraph num="(1)"> <text>Completed:</text> <paragraph num="(a)"> <text>An approved nursing assistant training program;</text> </paragraph> <paragraph num="(b)"> <text>An approved acute care nursing assistant training program;</text> </paragraph> <paragraph num="(c)"> <text>A portion of an approved nursing education program that has been determined by the Board to meet the requirements of a nursing assistant training program set by the Board; or</text> </paragraph> <paragraph num="(d)"> <text>Service member training and education that has been determined by the Board to be substantially equivalent to a nursing assistant training program approved by the Board in accordance with Health Occupations Article, §1-702, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Passed a nursing assistant competency evaluation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Certification by Endorsement. An applicant for nursing assistant certification by endorsement shall:</text> <paragraph num="(1)"> <text>Hold a certificate to practice as a nursing assistant that:</text> <paragraph num="(a)"> <text>Was issued by another state or territory of the United States that has certification requirements that are essentially similar to those set forth in Health Occupations Article, §8-6A-05, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is in good standing; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a nursing assistant training program that meets the standards for an approved nursing assistant training program set by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Any applicant for nursing assistant certification may not have:</text> <paragraph num="(1)"> <text>Committed any act or omission that would be grounds for discipline or denial of certification under Health Occupations Article, §8-6A-10, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>A record of abuse, negligence, or misappropriation of a client's property or any disciplinary action taken or pending in any other state or territory of the United States against the certification of the CNA.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nursing Education Programs.</text> <paragraph num="(1)"> <text>To meet the requirements of a nursing assistant training program set by the Board, a portion of a nursing education program must include courses with content that primarily focuses on:</text> <paragraph num="(a)"> <text>Nursing fundamentals;</text> </paragraph> <paragraph num="(b)"> <text>Mental health;</text> </paragraph> <paragraph num="(c)"> <text>Health assessment;</text> </paragraph> <paragraph num="(d)"> <text>Nursing ethics; and</text> </paragraph> <paragraph num="(e)"> <text>The content listed under 42 CFR §483.152(b).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a portion of a nursing education program does not include courses with content that primarily focuses on the subject matters set forth in § D(1) of this regulation, the Board may review and approve other equivalent subject matters as meeting the requirements of a nursing assistant training program set by the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A CNA-II who seeks certification as a CNA-1 shall meet the qualifications set forth in §A of this regulation.</text> </paragraph> <paragraph num="F."> <text>Temporary Nurse Aides.</text> <paragraph num="(1)"> <text>A temporary nurse aide applying for certification as a CNA-1 shall be deemed to have completed a nursing assistant training program approved by the Board if the temporary nurse aide:</text> <paragraph num="(a)"> <text>Completed a temporary nurse aide training course;</text> </paragraph> <paragraph num="(b)"> <text>Completed a minimum of 100 hours of on-the-job training as a temporary nurse aide that:</text> <paragraph num="(i)"> <text>Met the requirements under 42 CFR §483.152(a) and 42 CFR §483.152(b)(2)—(7); and</text> </paragraph> <paragraph num="(ii)"> <text>Was not provided in a facility described under 42 CFR §483.151(b)(2)—(3); and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In addition to the minimum 100 hours of on-the-job training, worked as a temporary nurse aide competently for a minimum of 160 hours.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A temporary nurse aide whose on-the-job training did not meet all of the requirements under 42 CFR 483.152(a) and 42 CFR 483.152(b)(2)—(7) may receive supplemental training in those requirements and be deemed to meet the requirement of §F(1)(b)(i) of this regulation.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Certification."> <paragraph num="A."> <text>Initial Certification.</text> <paragraph num="(1)"> <text>An applicant for initial certification shall:</text> <paragraph num="(a)"> <text>Comply with all of the requirements under Regulation .04A of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required fee to the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to the Board one of the items in §A(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Verification Requirements.</text> <paragraph num="(a)"> <text>For graduates of a nursing assistant or acute care nursing assistant training program, an application that has been signed by the program coordinator or faculty of the training program completed by the applicant;</text> </paragraph> <paragraph num="(b)"> <text>For service members, documentation demonstrating successful completion of service member training and education that has been determined by the Board to be substantially equivalent to a nursing assistant training program approved by the Board;</text> </paragraph> <paragraph num="(c)"> <text>For nursing students and graduates, an official transcript demonstrating successful completion of a portion of an approved nursing education program that the Board determines meets the requirements for a nursing assistant training program set by the Board; or</text> </paragraph> <paragraph num="(d)"> <text>For foreign-educated nursing graduates, a copy of an evaluation of the applicant’s transcript through a Board-approved vendor demonstrating successful completion of a portion of an approved nursing education program that meets the requirements for a nursing assistant training program set by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A program coordinator or faculty of a nursing assistant or acute care nursing assistant training program:</text> <paragraph num="(a)"> <text>May sign an application before graduation; and</text> </paragraph> <paragraph num="(b)"> <text>Shall submit written verification, as required by the Board, of program completion to the Board after 5 business days of the applicant’s program completion.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant shall submit an application for initial certification after 24 months of the date of completion of an approved nursing assistant training program, an approved acute care nursing assistant training program, or portion of an approved nursing education program.</text> </paragraph> <paragraph num="(5)"> <text>If an applicant fails to meet §A(4) of this regulation, an applicant still seeking certification shall take or re-take an approved nursing assistant training program or approved acute care nursing assistant training program and comply with §A(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Certification by Endorsement. An applicant for nursing assistant certification by endorsement shall:</text> <paragraph num="(1)"> <text>Comply with all of the requirements under Regulation .04A of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Pay the required fee to the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the following verifications directly to the Board from the appropriate authority:</text> <paragraph num="(a)"> <text>A certificate to practice as a nursing assistant in good standing from another state or territory with certification requirements that are essentially similar to the requirements in this State; and</text> </paragraph> <paragraph num="(b)"> <text>A certificate of completion from a nursing assistant training program in that state or territory that meets the standards for an approved nursing assistant training program set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Every applicant shall attest on the application whether the applicant has:</text> <paragraph num="(1)"> <text>Committed any act or omission that would be grounds for discipline or denial of certification; and</text> </paragraph> <paragraph num="(2)"> <text>A record of abuse, neglect, or misappropriation of a client’s property or any disciplinary action taken or pending in any state or territory of the United States against the certification of the applicant.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A CNA-II who seeks certification as a CNA-I shall:</text> <paragraph num="(1)"> <text>Submit an application to the Board on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with §§A(1)(c) and A(3)—(5) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A temporary nurse aide applying for certification as a CNA-1 shall:</text> <paragraph num="(1)"> <text>Comply with §A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the administrator, director of nursing, or human resources representative of the applicant’s employer submits to the Board an attestation, on the form required by the Board, that:</text> <paragraph num="(a)"> <text>Is completed by the:</text> <paragraph num="(i)"> <text>Applicant;</text> </paragraph> <paragraph num="(ii)"> <text>Registered Nurse instructor or supervisor of the applicant during employment; and</text> </paragraph> <paragraph num="(iii)"> <text>Administrator or director of nursing for the employer; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Verifies that the applicant satisfies the requirements of Regulation .05F of this chapter.</text> </paragraph> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".07" heading="Nursing Assistant Competency Evaluation."> <paragraph num="A."> <text>An individual is eligible to sit for a nursing assistant competency evaluation if the individual:</text> <paragraph num="(1)"> <text>Meets the education requirements set forth in Regulation .05A(1) of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Must retake a nursing assistant competency evaluation in order to renew or reinstate a certification in accordance with Regulation .10C(2)(a) of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except for service members, an individual shall sit for a nursing assistant competency evaluation after 24 months of meeting the educational requirements set forth in Regulation .05A(1) of this chapter.</text> </paragraph> <paragraph num="C."> <text>An individual who fails to sit for a nursing assistant competency evaluation after 24 months of meeting the educational qualifications must re-take an approved nursing assistant training program or approved acute care nursing assistant training program in order to be eligible to sit for a nursing assistant competency evaluation.</text> </paragraph> <paragraph num="D."> <text>Re-testing.</text> <paragraph num="(1)"> <text>An individual who fails to obtain a passing score on the first examination may retake a nursing assistant competency evaluation three additional times.</text> </paragraph> <paragraph num="(2)"> <text>An individual shall wait at least 45 calendar days from the date of the prior evaluation before retaking a nursing assistant competency evaluation.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to obtain a passing score after taking a nursing assistant competency evaluation four times must complete a new approved nursing assistant training program or approved acute care nursing assistant training program before retaking a nursing assistant competency evaluation.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".08" heading="Temporary Practice Certificate."> <paragraph num="A."> <text>The Board may issue a temporary practice certificate to an applicant who:</text> <paragraph num="(1)"> <text>Has met the appropriate certification requirements to the satisfaction of the Board;</text> </paragraph> <paragraph num="(2)"> <text>Does not have a criminal record; and</text> </paragraph> <paragraph num="(3)"> <text>Has not been the subject of a health professional disciplinary action in this State or another jurisdiction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless the Board suspends or revokes a temporary practice certificate, the temporary practice certificate expires 90 calendar days after the date of issuance.</text> </paragraph> <paragraph num="C."> <text>A temporary practice certificate may be extended up to an additional 90 calendar days if the applicant is awaiting the completion of the criminal history records check.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".09" heading="Issuance of Certification."> <paragraph num="A."> <text>The Board may not issue a certificate to an applicant until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history record information of the applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless subject to discipline, the Board shall issue a certificate to each applicant who meets all the requirements of this chapter and Health Occupations Article, §§8-6A-05 and 8-6A-06, Annotated Code of Maryland.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".10" heading="Expiration and Renewal."> <paragraph num="A."> <text>Expiration.</text> <paragraph num="(1)"> <text>Unless renewed for an additional two-year term, and except as otherwise provided in §A(2) of this regulation, a certificate expires in accordance with the following schedule:</text> <paragraph num="(a)"> <text>The certificate of a certificate holder with an odd-numbered birth year expires on the 28th day of the certificate holder’s birth month in an odd-numbered year; and</text> </paragraph> <paragraph num="(b)"> <text>The certificate of a certificate holder with an even-numbered birth year expires on the 28th day of the certificate holder’s birth month in an even-numbered year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A certificate shall not expire within 180 calendar days of the date of issuance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal Notice.</text> <paragraph num="(1)"> <text>At least 3 months before a certificate expires, the Board shall send the certificate holder a renewal notice by either:</text> <paragraph num="(a)"> <text>First-class mail to the last known address of the certificate holder; or</text> </paragraph> <paragraph num="(b)"> <text>Electronic means to the last known electronic address of the certificate holder.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The renewal notice shall provide:</text> <paragraph num="(a)"> <text>The date on which the certificate holder’s certificate is scheduled to expire;</text> </paragraph> <paragraph num="(b)"> <text>The date by which the Board must receive a renewal application in order for a certificate to remain active until the renewal application submitted by the certificate holder is processed by the Board, in accordance with State Government Article, §10-226(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>The amount of the renewal fee; and</text> </paragraph> <paragraph num="(d)"> <text>If the certificate holder is required to submit to a CHRC in accordance with §D of this regulation:</text> <paragraph num="(i)"> <text>Notice that the certificate holder must submit to a CHRC in order to renew the certificate; and</text> </paragraph> <paragraph num="(ii)"> <text>Written instructions for how to complete a CHRC.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>It is the responsibility of the certificate holder to:</text> <paragraph num="(a)"> <text>Be aware of the expiration date of the certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Renew the certificate before it expires.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Failure of a certificate holder to receive the renewal notice sent by the Board does not relieve the certificate holder of the responsibility to renew a certificate before it expires.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Renewal Requirements.</text> <paragraph num="(1)"> <text>The Board shall renew a certificate if the individual applying for renewal:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(b)"> <text>Submits a complete application for renewal on the form required by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Pays the renewal fee;</text> </paragraph> <paragraph num="(d)"> <text>Provides satisfactory evidence, as required by the Board, of16 hours of active employment, for compensation, as a nursing assistant within the 2-year period immediately preceding the date of expiration or meet the requirements under §C(2) of this regulation; and</text> </paragraph> <paragraph num="(e)"> <text>If required to submit to a CHRC in accordance with § D of this regulation, complies with the requirements of Regulation .04A of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the individual applying for renewal does not have 16 hours of active employment as a nursing assistant within the 2-year period immediately preceding the date of expiration the individual shall:</text> <paragraph num="(a)"> <text>If a CNA-I, take and pass a nursing assistant competency evaluation; or</text> </paragraph> <paragraph num="(b)"> <text>If a CNA-II, complete a nursing assistant training program..</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Schedule for CHRCs. CHRCs for renewal applicants shall be scheduled according to the certificate holder’s birth month as follows:</text> <paragraph num="(1)"> <text>In 2025 — all applicants with an August or September birth month;</text> </paragraph> <paragraph num="(2)"> <text>In 2026 — all applicants with a September or October birth month;</text> </paragraph> <paragraph num="(3)"> <text>In 2027 — all applicants with an October or November birth month;</text> </paragraph> <paragraph num="(4)"> <text>In 2028 — all applicants with a November or December birth month;</text> </paragraph> <paragraph num="(5)"> <text>In 2029 — all applicants with a December or January birth month;</text> </paragraph> <paragraph num="(6)"> <text>In 2030 — all applicants with a January or February birth month;</text> </paragraph> <paragraph num="(7)"> <text>In 2031 — all applicants with a February or March birth month;</text> </paragraph> <paragraph num="(8)"> <text>In 2032 — all applicants with a March or April birth month;</text> </paragraph> <paragraph num="(9)"> <text>In 2033 — all applicants with an April or May birth month;</text> </paragraph> <paragraph num="(10)"> <text>In 2034 — all applicants with a May or June birth month;</text> </paragraph> <paragraph num="(11)"> <text>In 2035 — all applicants with a June or July birth month; and</text> </paragraph> <paragraph num="(12)"> <text>In 2036 — all applicants with a July or August birth month.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Grace Period. A certificate holder has a 30 calendar day grace period beyond the expiration date of the certificate to renew the certificate.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".11" heading="Administrative Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate the certificate of a certificate holder who has failed to renew the certificate for any reason, if the certificate holder meets the renewal requirements in Health Occupations Article, §8-6A-08, Annotated Code of Maryland, and Regulation .10 of this chapter.</text> </paragraph> <paragraph num="B."> <text>An applicant for administrative reinstatement who has failed to renew the certificate for a period of 1 year or more shall submit to a CHRC before the certificate is reinstated.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205, 8-206, and 8-6A-01—8-6A-17, Annotated Code of Maryland; Ch. 486, Acts of 2012;Chs. 818 and 819, Acts of 2024; Ch. 416, Acts of 2025</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 5, 2001 (28:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02A, .06B, .09B amended as an emergency provision effective November 15, 2001 (28:24 Md. R. 2125); amended permanently effective February 18, 2002 (29:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective February 2, 2004 (31:2 Md. R. 85); August 27, 2007 (34:17 Md. R. 1509)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 25, 2008 (35:17 Md. R. 1489); April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06N amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed and Regulation .09 recodified to be Regulation .08 effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective April 7, 2008 (35:7 Md. R. 748)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective March 22, 2010 (37:6 Md. R. 478)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 13, 2017 (44:3 Md. R. 189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective September 22, 2022 (49:22 Md. R. 975); emergency status expired effective March 30, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted as an emergency provision effective September 22, 2022 (49:22 Md. R. 975); emergency status expired effective March 30, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective September 22, 2022 (49:22 Md. R. 975); emergency status expired effective March 30, 2023</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective September 22, 2022 (49:22 Md. R. 975); emergency status expired effective March 30, 2023</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective April 3, 2026 (53:9 Md. R. 411); amended permanently effective June 8, 2026 (53:11 Md. R. 484)</annotation> </annotations> </chapter> <chapter num="02" heading="Nursing Assistant Training Programs"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acute care nursing assistant training program” means a course of training that meets the acute care nursing assistant training program curriculum approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Certified Nursing Assistant (CNA)” has the meaning stated in COMAR 10.39.01.02B.</text> </paragraph> <paragraph num="(4)"> <text>Certified Nursing Assistant-I (CNA-I).</text> <paragraph num="(a)"> <text>“Certified nursing assistant-I (CNA-I)” means a CNA who:</text> <paragraph num="(i)"> <text>Meets the requirements set by the Board and federal law; and</text> </paragraph> <paragraph num="(ii)"> <text>May practice in any practice setting.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant-I (CNA-I)” includes a:</text> <paragraph num="(i)"> <text>CNA who was certified as a geriatric nursing assistant on March 31, 2026;</text> </paragraph> <paragraph num="(ii)"> <text>Certified medicine aide; and</text> </paragraph> <paragraph num="(iii)"> <text>CNA who is certified under Health Occupations Article, §8-6A-05(c)(5), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Classroom laboratory training” means instruction and demonstration, on an individual or a mannequin, of patient care skills by an instructor and return demonstration of competence in these skills by the student.</text> </paragraph> <paragraph num="(6)"> <text>“Clinical facility” means a setting where clients are physically present and that provides facilities for supervised clinical training.</text> </paragraph> <paragraph num="(7)"> <text>“Direct supervision” means that the registered nurse or licensed practical nurse is physically present while the student demonstrates patient care skills.</text> </paragraph> <paragraph num="(8)"> <text>“Distance education” means a formal education process in which the delivery of instruction occurs through the use of telecommunication technologies because the students and instructors are in different places.</text> </paragraph> <paragraph num="(9)"> <text>“Hybrid training program” means a nursing assistant training program that provides:</text> <paragraph num="(a)"> <text>Didactic instruction through distance education;</text> </paragraph> <paragraph num="(b)"> <text>On-site classroom laboratory training; and</text> </paragraph> <paragraph num="(c)"> <text>Supervised clinical training.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Licensed Practical Nurse (LPN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice licensed practical nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(12)"> <text>“Nursing assistant competency evaluation” means an examination approved by the Board that:</text> <paragraph num="(a)"> <text>Determines the competency of the individual to practice as a CNA-I; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements under federal law.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Nursing assistant training program” means a course of training approved by the Board that meets the requirements under federal and State law.</text> </paragraph> <paragraph num="(14)"> <text>“Program completion” means that the student:</text> <paragraph num="(a)"> <text>Completed and demonstrated competency in the program objectives and performance indicators during the didactic, laboratory, and clinical portions of the training program; and</text> </paragraph> <paragraph num="(b)"> <text>Passed the final written examination.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Program provider” means an individual, organization, facility, or educational institution that conducts a nursing assistant training program or an acute care nursing assistant training program.</text> </paragraph> <paragraph num="(16)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Supervised clinical training” means training in person at a clinical facility in which the student demonstrates knowledge and skills while performing tasks on a client under the supervision of an RN or an LPN.</text> </paragraph> <paragraph num="(18)"> <text>“Traditional program” means a training program that provides on-site didactic instruction, classroom laboratory training, and supervised clinical training.</text> </paragraph> <paragraph num="(19)"> <text>“Training program” means a nursing assistant training program or an acute care nursing assistant training program.</text> </paragraph> <paragraph num="(20)"> <text>“Unencumbered” means without limitation or restriction on practice, such as revocation, suspension, or probation.</text> </paragraph> <paragraph num="(21)"> <text>“Written agreement” means a contract between a program provider and a clinical facility outlining the terms required, by both the program and the facility, for supervised clinical training of students.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".02" heading="Initial Approval and Ongoing Responsibilities."> <paragraph num="A."> <text>Approval Requirements.</text> <paragraph num="(1)"> <text>All training programs shall be approved by:</text> <paragraph num="(a)"> <text>The Board; and</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Higher Education Commission (MHEC) in accordance with Health Occupations Article, §8-6A-14(a), Annotated Code of Maryland and COMAR 13B.01.01.03.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Public High School Training Programs. If the training program is offered by a public high school, the training program shall be approved by the State Board of Education.</text> </paragraph> <paragraph num="(3)"> <text>The approval process shall be completed before the training program is offered.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application. At least 120 days before the proposed start date of the training program, a program provider seeking initial approval of a training program shall:</text> <paragraph num="(1)"> <text>Submit a complete application on the form required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate that the training program meets all of the applicable requirements in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Provide any additional information requested by the Board during the Board’s review of the application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Board Action.</text> <paragraph num="(1)"> <text>Following receipt of a complete application, the Board’s professional staff may conduct a survey visit and submit a survey visit report to the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall:</text> <paragraph num="(a)"> <text>Approve a training program that meets all of the applicable requirements of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Deny approval of a training program that does not meet all of the applicable requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Term. Board approval of a training program is valid for 2 years.</text> </paragraph> <paragraph num="E."> <text>Ongoing Responsibilities.</text> <paragraph num="(1)"> <text>A training program shall obtain approval from the Board before making any substantial changes to the program.</text> </paragraph> <paragraph num="(2)"> <text>Substantial changes include:</text> <paragraph num="(a)"> <text>Changes to faculty;</text> </paragraph> <paragraph num="(b)"> <text>Significant changes to curriculum, including an increase or decrease in program hours; and</text> </paragraph> <paragraph num="(c)"> <text>Removal or addition of clinical facilities or classroom locations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A training program shall submit to the Board an annual report, on the form required by the Board, that includes statistics on enrollments, program completions, attrition rates, and nursing assistant competency evaluation results.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Nursing Assistant Competency Evaluation Performance.</text> <paragraph num="(1)"> <text>A training program shall maintain an average pass rate of 90 percent of the average pass rate for all states using the applicable Board-approved vendors for the nursing assistant competency evaluation.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall annually review the performance of graduates from each training program on the nursing assistant competency evaluation.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".03" heading="Administration."> <paragraph num="A."> <text>Equal Opportunity Statement. The training program provider shall have a statement of equal opportunity.</text> </paragraph> <paragraph num="B."> <text>A training program offered by a nursing facility or skilled nursing facility shall not charge a fee for any portion of the program, including textbooks and other required course materials, in accordance with 42 CFR §483.152(c).</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".04" heading="Faculty."> <paragraph num="A."> <text>Faculty Requirements.</text> <paragraph num="(1)"> <text>Each course instructor and program coordinator shall have:</text> <paragraph num="(a)"> <text>An active, unencumbered license to practice as a Registered Nurse or a multistate licensure privilege to practice as a Registered Nurse in the State;</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 2 years of nursing experience; and</text> </paragraph> <paragraph num="(c)"> <text>Completed a course in teaching adults or have experience in teaching adults or supervising nursing assistants.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Long-Term Care Facility Experience Requirements. Either the program coordinator or all course instructors shall have at least 1 year of experience in the provision of long-term care facility services, which may include:</text> <paragraph num="(a)"> <text>Providing direct client care or supervisory oversight in a long-term care facility or unit, including in a geriatrics department, chronic care hospital, or other long-term care setting; and</text> </paragraph> <paragraph num="(b)"> <text>Teaching a nursing assistant training program that complies with federal law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Course Instructors.</text> <paragraph num="(1)"> <text>Course instructors in training programs in public secondary schools in the State shall also meet the requirements set forth in COMAR 13A.12.02.02.</text> </paragraph> <paragraph num="(2)"> <text>The course instructor is responsible for:</text> <paragraph num="(a)"> <text>Participating in the development and evaluation of the training program, including the acquisition of learning resources and instructional materials;</text> </paragraph> <paragraph num="(b)"> <text>Implementing the training program and ensuring course objectives are met;</text> </paragraph> <paragraph num="(c)"> <text>Supervising classroom, laboratory, and clinical learning experiences, including direct supervision of a student the first time a student performs a patient care skill during a clinical learning experience and until the student demonstrates proficiency in that skill; and</text> </paragraph> <paragraph num="(d)"> <text>Evaluating student performance during didactic, clinical, and laboratory training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Program Coordinator.</text> <paragraph num="(1)"> <text>Each training program shall have a program coordinator who:</text> <paragraph num="(a)"> <text>Provides general supervision of the training of nursing assistants; and</text> </paragraph> <paragraph num="(b)"> <text>Maintains responsibility for the overall operation of the program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C(3) of this regulation, the program coordinator may also be a course instructor.</text> </paragraph> <paragraph num="(3)"> <text>In a facility-based program, the facility’s director of nursing may be the program coordinator but may not perform any actual training.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Supplemental Personnel.</text> <paragraph num="(1)"> <text>Other health professional personnel may supplement the course instructor, including, but not limited to:</text> <paragraph num="(a)"> <text>Registered nurses in accordance with §D(3) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Licensed practical nurses in accordance with §D(4) of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Pharmacists;</text> </paragraph> <paragraph num="(d)"> <text>Dietitians;</text> </paragraph> <paragraph num="(e)"> <text>Social workers;</text> </paragraph> <paragraph num="(f)"> <text>Sanitarians;</text> </paragraph> <paragraph num="(g)"> <text>Fire safety experts;</text> </paragraph> <paragraph num="(h)"> <text>Nursing home administrators;</text> </paragraph> <paragraph num="(i)"> <text>Gerontologists;</text> </paragraph> <paragraph num="(j)"> <text>Psychologists;</text> </paragraph> <paragraph num="(k)"> <text>Physical and occupational therapists;</text> </paragraph> <paragraph num="(l)"> <text>Activities specialists;</text> </paragraph> <paragraph num="(m)"> <text>Speech/language/hearing therapists; and</text> </paragraph> <paragraph num="(n)"> <text>Resident rights experts.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supplemental personnel shall have at least 1 year of experience in their respective field.</text> </paragraph> <paragraph num="(3)"> <text>A registered nurse functioning as supplemental personnel shall:</text> <paragraph num="(a)"> <text>Hold a current, unencumbered license in the State or multistate licensure privilege as a registered nurse; and</text> </paragraph> <paragraph num="(b)"> <text>Have had at least 1 year of direct client care experience as a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensed practical nurse functioning as supplemental personnel shall:</text> <paragraph num="(a)"> <text>Hold a current, unencumbered license in the State or multistate licensure privilege as a practical nurse; and</text> </paragraph> <paragraph num="(b)"> <text>Have had at least 1 year of direct client care experience as a licensed practical nurse.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Other supplemental personnel providing instruction shall provide instruction under the supervision of the course instructo.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".05" heading="Facilities and Resources."> <paragraph num="A."> <text>General Facility Requirements. All classroom, laboratory, and clinical facilities used by a training program:</text> <paragraph num="(1)"> <text>Shall be approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Shall be approved or accredited by the appropriate agency;</text> </paragraph> <paragraph num="(3)"> <text>May not be on conditional or provisional approval status; and</text> </paragraph> <paragraph num="(4)"> <text>May not meet any of the factors set forth in 42 CFR §483.151(b)(2)—(3).</text> </paragraph> </paragraph> <paragraph num="B."> <text>Classroom and Laboratory Facilities. Classroom and laboratory facilities shall include:</text> <paragraph num="(1)"> <text>Adequate space for privacy of faculty-student conferences; and</text> </paragraph> <paragraph num="(2)"> <text>Space for equipment and instructional materials.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Resources.</text> <paragraph num="(1)"> <text>All instructional learning resources and materials shall:</text> <paragraph num="(a)"> <text>Be accessible and relevant to the role of the CNA;</text> </paragraph> <paragraph num="(b)"> <text>Have a publication date not older than 5 years from the current year; and</text> </paragraph> <paragraph num="(c)"> <text>Be written at an 8th grade level.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Laboratory Equipment.</text> <paragraph num="(a)"> <text>Laboratory equipment, at a minimum, shall include materials to support the following classroom activities:</text> <paragraph num="(i)"> <text>Infection control;</text> </paragraph> <paragraph num="(ii)"> <text>Basic nursing skills;</text> </paragraph> <paragraph num="(iii)"> <text>Personal care skills; and</text> </paragraph> <paragraph num="(iv)"> <text>Basic restorative services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Board shall maintain on its website a list of the specific equipment required for laboratory facilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Facilities.</text> <paragraph num="(1)"> <text>Clinical facilities shall:</text> <paragraph num="(a)"> <text>Have a sufficient number and variety of clients to provide training experiences for all students to achieve the stated objectives;</text> </paragraph> <paragraph num="(b)"> <text>Have a sufficient number of registered nurses and other nursing personnel to ensure safe and continuous care of clients; and</text> </paragraph> <paragraph num="(c)"> <text>Conform with accepted standards of nursing care and practice.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>There shall be a minimum of 1 course instructor for each 8 students in the clinical area.</text> </paragraph> <paragraph num="(3)"> <text>Written Agreements.</text> <paragraph num="(a)"> <text>Except for facility-based programs, a training program shall have a written agreement with a clinical facility for student training experiences.</text> </paragraph> <paragraph num="(b)"> <text>The written agreement developed in accordance with §D(3)(a) of this regulation shall:</text> <paragraph num="(i)"> <text>Be developed jointly with the clinical facility and the training program;</text> </paragraph> <paragraph num="(ii)"> <text>Be reviewed periodically by the clinical facility and the training program;</text> </paragraph> <paragraph num="(iii)"> <text>Include a provision for adequate notice of termination;</text> </paragraph> <paragraph num="(iv)"> <text>Specify the responsibility of the training program to the clinical facility and the responsibility of the clinical facility to the training program; and</text> </paragraph> <paragraph num="(v)"> <text>Identify the functions and responsibilities of the parties involved.</text> </paragraph> </paragraph> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".06" heading="Curriculum."> <paragraph num="A."> <text>Program Hours.</text> <paragraph num="(1)"> <text>A training program shall provide a minimum of 100 hours of instruction.</text> </paragraph> <paragraph num="(2)"> <text>Of the 100 hours, a minimum of:</text> <paragraph num="(a)"> <text>60 hours shall be devoted to didactic instruction and classroom laboratory training, with at least 16 hours of in-person laboratory training in the pre-clinical curriculum listed in §B(3) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>40 hours shall be devoted to supervised clinical training in a clinical facility.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A training program shall have at least 16 of the 40 hours of supervised clinical training in the provision of long-term care facility services or caring for the elderly or chronically ill of any age, which shall be performed under direct supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Curriculum Content.</text> <paragraph num="(1)"> <text>The curriculum for a training program shall include the subject matters and skills listed in 42 CFR §483.152(b).</text> </paragraph> <paragraph num="(2)"> <text>The curriculum for an acute care nursing assistant training program shall include:</text> <paragraph num="(a)"> <text>The subject matters listed in 42 CFR §483.152(b); and</text> </paragraph> <paragraph num="(b)"> <text>All basic skills required of a nursing assistant in any acute care practice setting, including:</text> <paragraph num="(i)"> <text>Caring for patients with acute and chronic medical conditions in a hospital facility;</text> </paragraph> <paragraph num="(ii)"> <text>Observing and reporting changes in patient condition, including potential emergencies and safety issues, to the licensed nurse;</text> </paragraph> <paragraph num="(iii)"> <text>Transport of specimens;</text> </paragraph> <paragraph num="(iv)"> <text>Transport of medications;</text> </paragraph> <paragraph num="(v)"> <text>Point of care testing;</text> </paragraph> <paragraph num="(vi)"> <text>Specimen collecting;</text> </paragraph> <paragraph num="(vii)"> <text>Equipment management;</text> </paragraph> <paragraph num="(viii)"> <text>Time management in the acute care setting;</text> </paragraph> <paragraph num="(ix)"> <text>De-escalation of assertive or aggressive patients and family members; and</text> </paragraph> <paragraph num="(x)"> <text>Electronic documentation of care and basic computer skills.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The pre-clinical curriculum of a training program shall include the following topics:</text> <paragraph num="(a)"> <text>Role of the CNA;</text> </paragraph> <paragraph num="(b)"> <text>Infection control;</text> </paragraph> <paragraph num="(c)"> <text>Safety and emergency procedures, including the Heimlich maneuver;</text> </paragraph> <paragraph num="(d)"> <text>Communication and interpersonal skills;</text> </paragraph> <paragraph num="(e)"> <text>Promoting clients’ independence; and</text> </paragraph> <paragraph num="(f)"> <text>Legal and ethical considerations, including respecting clients’ rights.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A training program shall provide instruction in the pre-clinical curriculum before a student has any direct contact with a client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each training program shall identify the unit objectives and performance indicators for each of the areas in §B of this regulation in its training criteria.</text> </paragraph> <paragraph num="D."> <text>Laboratory Instruction and Clinical Learning Experience.</text> <paragraph num="(1)"> <text>Each training program shall provide laboratory instruction in and require students to demonstrate clinical competence in performing skills consistent with the subjects under §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A training program shall ensure that students may not perform any services during their clinical learning experience for which they have not trained and been found proficient by the course instructor.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".07" heading="Evaluation."> <paragraph num="A."> <text>Each training program shall have an objective final written examination that measures achievement of the performance indicators.</text> </paragraph> <paragraph num="B."> <text>To successfully complete the training program, each student shall:</text> <paragraph num="(1)"> <text>Complete the required minimum hours provided in Regulation .06A of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate the ability to perform nursing functions with clients of any age and with various levels of physical, sensory, cognitive, and emotional ability;</text> </paragraph> <paragraph num="(3)"> <text>Achieve a passing score of at least 75 percent on the written final examination; and</text> </paragraph> <paragraph num="(4)"> <text>Demonstrate competence in meeting the objectives and performance indicators during didactic, laboratory, and clinical instruction.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The training program shall provide the following to students who complete the program:</text> <paragraph num="(1)"> <text>A certificate of completion using the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Registration information for a nursing assistant competency evaluation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A program coordinator or faculty of a training program:</text> <paragraph num="(1)"> <text>May sign a student’s application for certification as a nursing assistant before graduation; and</text> </paragraph> <paragraph num="(2)"> <text>Shall submit to the Board written verification, as required by the Board, of each student’s program completion within 5 business days of program completion.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".08" heading="Renewal of Approval."> <paragraph num="A."> <text>Expiration. Unless renewed, Board approval of a training program expires 2 years from the last date of approval.</text> </paragraph> <paragraph num="B."> <text>Renewal application. At least 120 days before the date of expiration of approval, a training program shall submit:</text> <paragraph num="(1)"> <text>A complete application on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>All accompanying documentation required by the application or requested by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Survey Visit. Following receipt of a renewal application from a training program, the Board’s professional staff shall conduct an announced or unannounced on-site survey visit and submit a survey visit report to the Board.</text> </paragraph> <paragraph num="D."> <text>Board Action. The Board shall:</text> <paragraph num="(1)"> <text>Renew approval of a training program for another 2-year term if the training program meets the applicable requirements of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Initiate withdrawal of approval proceedings in accordance with Regulation .09 of this chapter if the training program fails to meet the applicable requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Enrollment. A training program that fails to renew its approval:</text> <paragraph num="(1)"> <text>Shall be listed on nonrenewed status in the Board’s records; and</text> </paragraph> <paragraph num="(2)"> <text>May not enroll any new students to the program following the expiration of approval.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".09" heading="Withdrawal of Approval."> <paragraph num="A."> <text>Notice of Deficiencies.</text> <paragraph num="(1)"> <text>If the Board determines that there is a basis for withdrawal of approval under §C of this regulation, the Board shall issue a written notice of deficiencies to the training program.</text> </paragraph> <paragraph num="(2)"> <text>The notice of deficiencies shall notify the training program of the:</text> <paragraph num="(a)"> <text>Requirements with which the program has not complied;</text> </paragraph> <paragraph num="(b)"> <text>Reasons for the Board’s determination; and</text> </paragraph> <paragraph num="(c)"> <text>Requirement to submit a written plan of correction in accordance with §B of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Written Plan of Correction.</text> <paragraph num="(1)"> <text>A training program shall submit a written plan of correction after 30 calendar days of the date of the notice of deficiencies unless granted an extension by the Board for good cause.</text> </paragraph> <paragraph num="(2)"> <text>The written plan of correction shall:</text> <paragraph num="(a)"> <text>Address all deficiencies noted by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Include dates of completion for correcting the deficiencies.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board shall review the plan of correction and may approve or modify the dates of completion for correcting deficiencies.</text> </paragraph> <paragraph num="(4)"> <text>The training program shall correct the deficiencies within the time frame approved by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Grounds for Withdrawal. The Board may withdraw approval of a training program that:</text> <paragraph num="(1)"> <text>Fails to comply with any of the applicable requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Fails to correct deficiencies within the time frame approved by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Enrolls new students after expiration of approval; or</text> </paragraph> <paragraph num="(4)"> <text>Has a graduate pass rate of less than 90 percent of the pass rate for all states using the applicable Board-approved vendors for a nursing assistant competency evaluation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Procedure for Withdrawal.</text> <paragraph num="(1)"> <text>Before withdrawing approval of a training program under §C of this regulation, the Board shall:</text> <paragraph num="(a)"> <text>Notify the program of its intent to withdraw approval; and</text> </paragraph> <paragraph num="(b)"> <text>Give the program an opportunity to request an evidentiary hearing before the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice of intent to withdraw approval and hearing shall comply with the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mandatory Withdrawal. Notwithstanding any other section of this regulation, the Board shall withdraw approval of a training program upon receipt of notice from the Office of Healthcare Quality that the facility is prohibited from holding a training program pursuant 42 CFR §483.151(f)(1) or 42 CFR §483.151(f)(3).</text> </paragraph> <paragraph num="F."> <text>Reinstatement. A training program whose approval was withdrawn may apply for reinstatement of approval by submitting a reinstatement application demonstrating that the program meets all of the applicable requirements of this chapter.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".10" heading="Voluntary Closure."> <paragraph num="A."> <text>When a training program provider considers closing a program, the training program provider shall:</text> <paragraph num="(1)"> <text>Notify the Board in writing of:</text> <paragraph num="(a)"> <text>The intended closing date; and</text> </paragraph> <paragraph num="(b)"> <text>The arrangements for custody and safeguarding of student and graduate records; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Continue the program until the committed class schedule of currently enrolled students is completed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Custody of Student Records.</text> <paragraph num="(1)"> <text>If the training program provider is a facility or educational institution that will continue to function, the facility or educational institution shall assume responsibility for the student and graduate records of the closed training program.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §B(1) of this regulation, a training program provider that is required to obtain approval from the Maryland Higher Education Commission (MHEC) shall file student and graduate records, or legible copies of those records, with MHEC in accordance with Education Article, §11-401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>A training program provider that is not required to obtain MHEC approval shall reach a mutual agreement with the Board about the disposition of student records.</text> </paragraph> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <regulation prefix="Regulation" num=".11" heading="Hybrid Nursing Assistant Training Programs."> <paragraph num="A."> <text>Scope. This regulation applies to hybrid nursing assistant training programs.</text> </paragraph> <paragraph num="B."> <text>Approval. The Board shall approve a hybrid training program that meets all of the requirements of this regulation.</text> </paragraph> <paragraph num="C."> <text>Prerequisite Qualifications. A program seeking initial approval as a hybrid training program shall:</text> <paragraph num="(1)"> <text>Comply with the requirements set forth in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Be approved by the Board as a traditional training program for at least 2 years before the program applies for initial approval as a hybrid training program; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with all requirements set forth under this chapter and be in good standing with the Board at the time that the program applies for initial approval as a hybrid training program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Application and Approval Requirements.</text> <paragraph num="(1)"> <text>A training program seeking initial approval as a hybrid training program shall apply for approval on a form required by the Board.</text> </paragraph> <paragraph num="(2)"> <text>To be eligible for Board approval, a hybrid training program shall:</text> <paragraph num="(a)"> <text>Host sessions no longer than 4 hours per session;</text> </paragraph> <paragraph num="(b)"> <text>Specify the technology platform to be used for each content area of the curriculum;</text> </paragraph> <paragraph num="(c)"> <text>Conduct lab and clinical training:</text> <paragraph num="(i)"> <text>In person with a course instructor who meets the requirements under Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>No later than 2 weeks after the completion of didactic instruction;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Require test sessions to be conducted in person;</text> </paragraph> <paragraph num="(e)"> <text>Have a policy, which is provided to the Board as a part of the application, for:</text> <paragraph num="(i)"> <text>Admissions, including determining whether a student has sufficient access to a computer and learning resources;</text> </paragraph> <paragraph num="(ii)"> <text>Orienting students to online modules;</text> </paragraph> <paragraph num="(iii)"> <text>Providing troubleshooting assistance for enrolled students; and</text> </paragraph> <paragraph num="(iv)"> <text>In the case of technology failure, an alternative method of instruction and notification to the Board of the technology failure and the use of the alternative method of instruction;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Have sufficient mechanisms for:</text> <paragraph num="(i)"> <text>Requiring the use of a personal identification number that confirms the identity of the students and instructor;</text> </paragraph> <paragraph num="(ii)"> <text>Ensuring that all students have demonstrated competency on all virtual education content;</text> </paragraph> <paragraph num="(iii)"> <text>Tracking and auditing active student participation in online instruction;</text> </paragraph> <paragraph num="(iv)"> <text>Confirming student identity during and after completion of online modules and live sessions; and</text> </paragraph> <paragraph num="(v)"> <text>Safeguarding appropriate security measures;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Provide the Board with access rights to the program to verify program compliance and monitor distance learning sessions; and</text> </paragraph> <paragraph num="(h)"> <text>Provide the Board with statistics about the performance of students in the program, including:</text> <paragraph num="(i)"> <text>Student exam pass rates;</text> </paragraph> <paragraph num="(ii)"> <text>The rate at which students repeat each module of the program; and</text> </paragraph> <paragraph num="(iii)"> <text>Any other information requested by the Board regarding student participation in and</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reapproval. An approved hybrid training program shall apply for renewal of approval in accordance with Regulation .08 of this chapter.</text> </paragraph> <paragraph num="F."> <text>Withdrawal of Approval. The Board may withdraw approval of a hybrid training program in accordance with Regulation .09 of this chapter.</text> </paragraph> <annotations> <annotation type="History" /> </annotations> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205, 8-6A-05(a)(6), and 8-6A-14, Annotated Code of Maryland; Chs. 818 and 819, Acts of 2024; Ch. 416, Acts of 2025</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 30, 2001 (28:8 Md. R. 761)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective November 7, 2005 (32:22 Md. R. 1756)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective April 3, 2026 (53:9 Md. R. 411); amended permanently effective June 8, 2026 (53:11 Md. R. 484)</annotation> </annotations> </chapter> <chapter num="03" heading="Certified Medicine Aides"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Certificate” means a certificate issued by the Board to practice as a nursing assistant in this State.</text> </paragraph> <paragraph num="(3)"> <text>“Certified medicine aide (CMA)” means an individual certified in good standing as an active CNA who:</text> <paragraph num="(a)"> <text>Satisfies the requirements of COMAR 10.39.03.02; and</text> </paragraph> <paragraph num="(b)"> <text>Is further certified by the Board to accept delegation of administration of certain medications.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Certified Nursing Assistant (CNA).</text> <paragraph num="(a)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who, for compensation and subject to regulations adopted by the Board, routinely performs:</text> <paragraph num="(i)"> <text>Nursing tasks delegated by a registered nurse, licensed practical nurse, or advanced practice registered nurse; or</text> </paragraph> <paragraph num="(ii)"> <text>Technical tasks delegated by a licensed certified midwife.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant (CNA)” does not include dialysis technician or medication technician.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Certified Nursing Assistant-I (CNA-I).</text> <paragraph num="(a)"> <text>“Certified nursing assistant-I (CNA-I)” means a CNA who:</text> <paragraph num="(i)"> <text>Meets the requirements set by the Board and federal law; and</text> </paragraph> <paragraph num="(ii)"> <text>May practice in any practice setting.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant-I (CNA-I)” includes a:</text> <paragraph num="(i)"> <text>CNA who was certified as a geriatric nursing assistant on March 31, 2026;</text> </paragraph> <paragraph num="(ii)"> <text>Certified medicine aide; and</text> </paragraph> <paragraph num="(iii)"> <text>CNA who is certified pursuant to § 8-6A-05(c)(5) of the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Certified nursing assistant-II (CNA-II)” means a CNA who:</text> <paragraph num="(a)"> <text>On March 31, 2026, was certified as a CNA but not certified as a geriatric nursing assistant; and</text> </paragraph> <paragraph num="(b)"> <text>May not practice in a nursing facility or skilled nursing facility.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Controlled schedule drugs” means drugs listed as Schedule I, II, III, IV, or V controlled dangerous substances under Criminal Law Article, §§5-402 — 5-406, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed practical nurse (LPN)” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Registered nurse (RN)” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification and Qualification."> <paragraph num="A."> <text>An applicant for certification as a CMA shall provide evidence satisfactory to the Board of meeting the following requirements:</text> <paragraph num="(1)"> <text>Current certification by the Board as an active CNA-1 in good standing;</text> </paragraph> <paragraph num="(2)"> <text>Current employment and work experience as required by the Board in a setting acceptable to the Board, including:</text> <paragraph num="(a)"> <text>Current employment and 2 years of full-time experience as a CNA-1 in a facility licensed under 42 CFR Part 483 et seq.; or</text> </paragraph> <paragraph num="(b)"> <text>Current employment and 1 year of full-time experience as a CNA-I in a facility licensed in Maryland under COMAR 10.07.02; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Successful completion as evidenced by a certificate of completion from a Board-approved CMA training program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The community college shall submit verification of successful completion of the CMA training program to the Board within 5 business days after completion of the program in a manner prescribed by the Board.</text> </paragraph> <paragraph num="C."> <text>Before renewal of certification as a CMA, and subject to the requirements in Health Occupations Article, §8-6A-08, Annotated Code of Maryland, and COMAR 10.39.01.09, the applicant shall:</text> <paragraph num="(1)"> <text>Successfully complete a Board-approved 8-hour medicine aide continuing education program as required by Regulation .03B of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Provide satisfactory evidence of completion of 100 hours of practice as a certified medicine aide in the 2-year period preceding the date of renewal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Medicine Aide Course Requirements."> <paragraph num="A."> <text>Medicine Aide Course Curriculum. The Board shall approve a CMA program that:</text> <paragraph num="(1)"> <text>Requires a candidate for admission to the program have current employment and work experience as set forth in Regulation .02A(2) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Requires before admission that a candidate have a positive recommendation from the director of nursing in the facility where the candidate is employed;</text> </paragraph> <paragraph num="(3)"> <text>Is at least 60 hours in length with a minimum of 30 clock hours devoted to theoretical instruction and a minimum of 30 clock hours of supervised clinical training experience in a facility licensed under COMAR 10.07.02;</text> </paragraph> <paragraph num="(4)"> <text>Includes instruction in both theory and clinical regarding all approved routes of medication administration and the scope of responsibility of the CMA; and</text> </paragraph> <paragraph num="(5)"> <text>Includes each of the following subjects:</text> <paragraph num="(a)"> <text>Responsibilities and limitations of the CMA;</text> </paragraph> <paragraph num="(b)"> <text>Drug standards, references, and resources;</text> </paragraph> <paragraph num="(c)"> <text>Legislation concerning drug utilization;</text> </paragraph> <paragraph num="(d)"> <text>Characteristics of the elderly client or client with multiple handicaps;</text> </paragraph> <paragraph num="(e)"> <text>Sources and purposes of drugs;</text> </paragraph> <paragraph num="(f)"> <text>Dosage forms and methods of administration;</text> </paragraph> <paragraph num="(g)"> <text>Drug life;</text> </paragraph> <paragraph num="(h)"> <text>The medication order;</text> </paragraph> <paragraph num="(i)"> <text>The pharmacy label;</text> </paragraph> <paragraph num="(j)"> <text>The administration of nonparenteral medications;</text> </paragraph> <paragraph num="(k)"> <text>Procedures and techniques for administering drugs;</text> </paragraph> <paragraph num="(l)"> <text>Drug classification, related health problems, and patient care responsibilities;</text> </paragraph> <paragraph num="(m)"> <text>Drug solutions and measurements; and</text> </paragraph> <paragraph num="(n)"> <text>Monitoring side effects of drugs and drug interactions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Medicine Aide Continuing Education Curriculum. Continuing education courses required for continued listing as a CMA as required in Regulation .02C of this chapter shall contain:</text> <paragraph num="(1)"> <text>A 3-hour core content that includes:</text> <paragraph num="(a)"> <text>Current State regulations related to the role of the medicine aide;</text> </paragraph> <paragraph num="(b)"> <text>Uses, actions, and possible interactions of and related precautions for current medications used in the care of the geriatric patient;</text> </paragraph> <paragraph num="(c)"> <text>New care procedures; and</text> </paragraph> <paragraph num="(d)"> <text>Resources available to the medicine aide which clarify and expand the knowledge of the medicine aide; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>3 hours on at least three of the following topics:</text> <paragraph num="(a)"> <text>Documentation;</text> </paragraph> <paragraph num="(b)"> <text>Nutrition;</text> </paragraph> <paragraph num="(c)"> <text>The physiological system of the geriatric patient;</text> </paragraph> <paragraph num="(d)"> <text>De-institutionalization of the intellectually disabled or psychiatric patient; or</text> </paragraph> <paragraph num="(e)"> <text>Other aspects of pharmacology; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>2 hours of assessment testing administered at the completion of the continuing education course.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Responsibility."> <paragraph num="A."> <text>The CMA may be delegated medication administration by the RN or LPN under the following conditions:</text> <paragraph num="(1)"> <text>The licensed nursing supervision requirements in Regulation .05 of this chapter have been met;</text> </paragraph> <paragraph num="(2)"> <text>The CMA is assigned to administer medication;</text> </paragraph> <paragraph num="(3)"> <text>There is a written medication order;</text> </paragraph> <paragraph num="(4)"> <text>The CMA is physically present on a continuing basis in the unit of care to accomplish the following as instructed and directed by the RN or LPN:</text> <paragraph num="(a)"> <text>Monitor the therapeutic effects of the medication;</text> </paragraph> <paragraph num="(b)"> <text>Observe and report untoward effects of the medication;</text> </paragraph> <paragraph num="(c)"> <text>Report observed changes in client behavior and clinical status; and</text> </paragraph> <paragraph num="(d)"> <text>Withhold administration of the medication if necessary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The CMA may perform the following RN or LPN delegated nursing functions:</text> <paragraph num="(1)"> <text>Prepare, administer, and chart medications administered:</text> <paragraph num="(a)"> <text>Orally;</text> </paragraph> <paragraph num="(b)"> <text>By nebulizer, metered dose inhalant, and, in the case of oxygen, by nasal cannula or mask;</text> </paragraph> <paragraph num="(c)"> <text>Topically, excluding wound or decubitus site care;</text> </paragraph> <paragraph num="(d)"> <text>By suppository; and</text> </paragraph> <paragraph num="(e)"> <text>By eye, ear, and nose drops;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Prepare, administer, and chart:</text> <paragraph num="(a)"> <text>Nonlegend PRN medications; and</text> </paragraph> <paragraph num="(b)"> <text>Controlled schedule drugs after the RN or LPN:</text> <paragraph num="(i)"> <text>Makes a bedside assessment of the patient;</text> </paragraph> <paragraph num="(ii)"> <text>Documents the assessment; and</text> </paragraph> <paragraph num="(iii)"> <text>Gives permission to the CMA to administer that medication; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the licensed nurse delegating medication administration provides access to the controlled schedule drug cabinet, sign for and administer controlled schedule drugs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Supervision."> <text>The CMA may administer medications when:</text> <paragraph num="A."> <text>In a setting licensed under COMAR 10.07.02, the licensed nurse is physically present and immediately available on the unit of care in which the client resides to provide direct supervision of any client who receives medication administered by the CMA; and</text> </paragraph> <paragraph num="B."> <text>In a setting licensed under 42 CFR Part 483 et seq., the licensed nurse is on-site and physically available to the CMA and the CMA administers medications only to clients whose clinical status is:</text> <paragraph num="(1)"> <text>Chronic;</text> </paragraph> <paragraph num="(2)"> <text>Stable;</text> </paragraph> <paragraph num="(3)"> <text>Uncomplicated; and</text> </paragraph> <paragraph num="(4)"> <text>Permitting placement in the community.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Unlawful Delegation."> <text>The RN or LPN may not delegate the following duties to the CMA:</text> <paragraph num="A."> <text>Transcription of original physician orders to medication and treatment administration records, charts, or Kardexes;</text> </paragraph> <paragraph num="B."> <text>Charge level responsibilities, including receiving instructions for or being assigned to such responsibilities;</text> </paragraph> <paragraph num="C."> <text>Administration of medication to clients whose clinical status is acutely unstable, complex, or medically fragile in a setting licensed under 42 CFR Part 483 et seq.;</text> </paragraph> <paragraph num="D."> <text>Administration of medication by way of the following routes:</text> <paragraph num="(1)"> <text>Injection;</text> </paragraph> <paragraph num="(2)"> <text>Intravenous route; and</text> </paragraph> <paragraph num="(3)"> <text>By way of a tube inserted in a cavity of the body, including nasogastric or gastrostomy tube feeding;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Client teaching;</text> </paragraph> <paragraph num="F."> <text>Acceptance of verbal or telephone orders; and</text> </paragraph> <paragraph num="G."> <text>Responsibility for maintaining possession of the keys or access code to the locked container for controlled schedule drugs.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a) and (c) and 8-6A-01 — 8-6A-16, Annotated Code of MarylandChs. 818 and 819, Acts of 2024; Ch. 416, Acts of 2025</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 5, 2001 (28:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective October 30, 2001 (28:23 Md. R. 2052); amended permanently effective February 18, 2002 (29:3 Md. R. 221)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .04 repealed and new Regulations .01 — .06 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective April 3, 2026 (53:9 Md. R. 411); amended permanently effective June 8, 2026 (53:11 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, C amended as an emergency provision effective April 3, 2026 (53:9 Md. R. 411); amended permanently effective June 8, 2026 (53:11 Md. R. 484)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective August 25, 2008 (35:17 Md. R. 1489)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 15, 2013 (40:7 Md. R. 612)</annotation> </annotations> </chapter> <chapter num="04" heading="Medication Technicians"> <regulation prefix="Regulation" num=".01" heading="Exclusions."> <text>This chapter does not apply to an individual who is:</text> <paragraph num="A."> <text>Practicing a health occupation, other than as medication technician, that the individual is authorized to perform under Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>A student enrolled in an approved nursing education program while practicing registered nursing or licensed practical nursing in that program;</text> </paragraph> <paragraph num="C."> <text>Providing gratuitous care of friends or family members;</text> </paragraph> <paragraph num="D."> <text>Performing medication technician tasks while a student practicing under the direct supervision of qualified faculty in a Board-approved medication technician training program; or</text> </paragraph> <paragraph num="E."> <text>Working as a school principal or school secretary, does not administer medication as a routine part of the position, and, after completing training by the school's delegating nurse, administers medication due to the absence of the nurse or medication technician.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“Certificate” means a certificate issued by the Board to practice as a certified medication technician in this State.</text> </paragraph> <paragraph num="(3)"> <text>Certified Nursing Assistant (CNA).</text> <paragraph num="(a)"> <text>“Certified nursing assistant (CNA)” means an individual, regardless of title, who:</text> <paragraph num="(i)"> <text>Routinely performs delegated nursing tasks which were delegated by a registered nurse (RN) or licensed practice nurse (LPN) for compensation; and</text> </paragraph> <paragraph num="(ii)"> <text>Is certified under COMAR 10.39.01.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified nursing assistant (CNA)” does not include:</text> <paragraph num="(i)"> <text>A medication technician; or</text> </paragraph> <paragraph num="(ii)"> <text>An individual who merely provides assistance with activities of daily living unless the client's needs are such that adverse health consequences are predictable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Clinical refresher course” means a course of study approved by the Board to maintain the medication technician's knowledge and skill to administer medication.</text> </paragraph> <paragraph num="(5)"> <text>“Licensed practical nurse (LPN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice licensed practical nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Medication technician (MT)” means an individual who:</text> <paragraph num="(a)"> <text>Has successfully completed a Board-approved MT training program;</text> </paragraph> <paragraph num="(b)"> <text>Meets any other qualifications set by the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Is certified by the Board as a MT.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Medication technician training program” means a course of training approved by the Board that meets the basic MT core curriculum and content training specific to the setting in which the MT will work.</text> </paragraph> <paragraph num="(8)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(9)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fees."> <paragraph num="A."> <text>Fees are as follows:</text> <paragraph num="(1)"> <text>Initial certification fee . . . $20;</text> </paragraph> <paragraph num="(2)"> <text>Renewal fee . . . $30;</text> </paragraph> <paragraph num="(3)"> <text>Returned check fee . . . $25; and</text> </paragraph> <paragraph num="(4)"> <text>Duplicate certification fee . . . $10.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fees are not refundable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Applicants for Certification."> <paragraph num="A."> <text>An applicant for MT certification shall:</text> <paragraph num="(1)"> <text>Be 18 years old or older; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board:</text> <paragraph num="(a)"> <text>An application to the Board on the form required by the Board and signed by the RN that taught the applicant's medication technician training program; and</text> </paragraph> <paragraph num="(b)"> <text>The required fee; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be of good moral character.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for MT certification may not have:</text> <paragraph num="(1)"> <text>Committed any act or omission that would be grounds for discipline or denial of certification under this subtitle; or</text> </paragraph> <paragraph num="(2)"> <text>A record of abuse, negligence, misappropriation of a resident's property, or any disciplinary action taken or pending in any state or territory of the United States against any certificate or license issued to the applicant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for MT certification from any other state, territory, or country shall meet all requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>An applicant who reports a positive criminal history on any application shall provide:</text> <paragraph num="(1)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>In an answer to a question on the Board’s application form; or</text> </paragraph> <paragraph num="(b)"> <text>From any other source; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §D(1) of this section is incomplete or insufficient.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to complete the application and provide all information and documents required under §D of this regulation.</text> </paragraph> <paragraph num="F."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board under §D of this regulation within 12 months from the date the application is received by the Board, then the application shall be considered abandoned and may be destroyed.</text> </paragraph> <paragraph num="G."> <text>Once an application is deemed abandoned under §F of this regulation, an individual seeking MT certification must submit a new application and meet all of the requirements for MT certification and pay the required fees that are in effect at the time of re-application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewal of Certification."> <paragraph num="A."> <text>The Board shall renew the certificate of each certificate holder who meets the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The certificate holder shall renew the certificate every 2 years by birth month.</text> </paragraph> <paragraph num="C."> <text>At least 3 months before a certificate expires, the Board shall send the certificate holder a renewal notice by:</text> <paragraph num="(1)"> <text>First-class mail to the last known address of the certificate holder; or</text> </paragraph> <paragraph num="(2)"> <text>Electronic means to the last known electronic address of the certificate holder.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual applying for renewal of certification shall provide evidence of:</text> <paragraph num="(1)"> <text>Satisfactory completion of a Board-approved clinical refresher course; and</text> </paragraph> <paragraph num="(2)"> <text>Completion of 100 hours of practice as a certified medicine technician within the 2-year period preceding the date of renewal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Approved Training Program."> <paragraph num="A."> <text>A Board-approved MT training program shall meet the requirements stated in this regulation and in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The MT training program:</text> <paragraph num="(1)"> <text>Shall utilize the Board-approved uniform curriculum, including the math and English proficiency examinations, to teach the MT training program;</text> </paragraph> <paragraph num="(2)"> <text>Shall contain 20 hours of curriculum content, including 4 hours of content addressing common disease processes and high-risk medications specific to the client population of the practice setting in which the enrolled student will practice upon certification;</text> </paragraph> <paragraph num="(3)"> <text>May not have classes exceeding 6 classroom clock hours at one time;</text> </paragraph> <paragraph num="(4)"> <text>Shall have at least one instructor per 15 students; and</text> </paragraph> <paragraph num="(5)"> <text>Shall submit verification of the applicant's successful completion of the MT course on a form required by the Board within 5 business days.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each faculty member for an MT training program shall be an RN who:</text> <paragraph num="(1)"> <text>Is licensed by the Board to practice registered nursing or has a multistate licensure privilege to practice registered nursing; and</text> </paragraph> <paragraph num="(2)"> <text>Has completed a course of instruction approved by the Board designed to instruct the RN on how to teach the MT training program for the specific practice setting in which the enrolled students are to work.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Change in Name or Address."> <paragraph num="A."> <text>Each certificate holder shall notify the Board in writing of any change in name or address within 30 days of the change.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a fine of $25 for failure to notify the Board of a change in name or address.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Expiration of Certificate."> <paragraph num="A."> <text>The certificate expires every 2 years on the 28th day of the certificate holder's birth month.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a civil fine, not to exceed $50, on a medication technician who:</text> <paragraph num="(1)"> <text>Fails to renew a certificate within 30 days after the expiration date; and</text> </paragraph> <paragraph num="(2)"> <text>Practices as an MT during the period of expiration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Nursing Functions."> <paragraph num="A."> <text>Administration of medication is a licensed nursing function. As such, the nurse retains full responsibility when delegating this nursing function.</text> </paragraph> <paragraph num="B."> <text>In community-based practice settings, the MT:</text> <paragraph num="(1)"> <text>May perform delegated medication administration functions as set forth in COMAR 10.27.11.05G(3) and 10.07.14; and</text> </paragraph> <paragraph num="(2)"> <text>Shall be supervised by the RN as specified in COMAR 10.27.09, 10.27.11, and 10.07.14.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The MT may perform the delegated nursing function of medication administration as permitted under COMAR 10.27.11.05H(3), which includes the administration of:</text> <paragraph num="(1)"> <text>Medication by metered dose inhalant or nebulizer, and oxygen by nasal cannula or mask;</text> </paragraph> <paragraph num="(2)"> <text>Medication by gastrostomy tube or rectal tube if the nurse has calculated the dosage;</text> </paragraph> <paragraph num="(3)"> <text>Oral medication, including:</text> <paragraph num="(a)"> <text>Measuring as prescribed an amount of liquid medication where the nurse has calculated the dose; and</text> </paragraph> <paragraph num="(b)"> <text>Administering a fraction of a tablet if the nurse has cut the tablet;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Medication by subcutaneous injection after the nurse has calculated the dose;</text> </paragraph> <paragraph num="(5)"> <text>Medication administered by topical route as specified in COMAR 10.27.11.05H(3)(e) and (h);</text> </paragraph> <paragraph num="(6)"> <text>Medication administered by suppository route; and</text> </paragraph> <paragraph num="(7)"> <text>Medication drops administered by routes involving eye, ear, or nose.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Prohibited Acts."> <paragraph num="A."> <text>The MT may not:</text> <paragraph num="(1)"> <text>Calculate any medication dose;</text> </paragraph> <paragraph num="(2)"> <text>Administer medications by:</text> <paragraph num="(a)"> <text>Injection, except as specified in Regulation .09C(4) of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Way of a tube inserted in a cavity of the body, except as specified in Regulation .09C(2) of this chapter; or</text> </paragraph> <paragraph num="(c)"> <text>Intravenous route;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Transcribe verbal orders;</text> </paragraph> <paragraph num="(4)"> <text>Fill medication assistive devices such as mediplanners or time-dose medication containers with medication;</text> </paragraph> <paragraph num="(5)"> <text>Package or repackage medications that are prescribed, ordered, over-the-counter, or herbal;</text> </paragraph> <paragraph num="(6)"> <text>Perform certified nursing assistant duties unless certified as a nursing assistant by the Board or otherwise authorized by Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Provide medication administration teaching; or</text> </paragraph> <paragraph num="(8)"> <text>Delegate medication administration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual who is not certified as an MT under this chapter may not:</text> <paragraph num="(1)"> <text>Represent by title of “certified medication technician” or “MT”, by description of services, methods, or procedures or otherwise, that the individual is authorized to practice as a certified medication technician;</text> </paragraph> <paragraph num="(2)"> <text>Use the words or terms “medication technician”, “MT”, “CMT”, or any other abbreviation, title, symbol, sign, card, device, or other representation, with the intent to represent that the person practices as a certified medication technician; or</text> </paragraph> <paragraph num="(3)"> <text>Practice, attempt to practice, or offer to practice as a certified medication technician.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a) and 8-6A-01—8-6A-16, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 24, 2006 (33:8 Md. R. 734)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 13, 2017 (44:3 Md. R. 189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective August 25, 2008 (35:17 Md. R. 1489)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective March 12, 2007 (34:5 Md. R. 561)</annotation> </annotations> </chapter> <chapter num="05" heading="Standards of Practice for Certified Nursing Assistants (CNA)"> <regulation prefix="Regulation" num=".01" heading="Exclusions."> <text>This chapter is not applicable to and does not restrict or limit:</text> <paragraph num="A."> <text>Other health care practitioners who are authorized to perform these duties under their respective acts;</text> </paragraph> <paragraph num="B."> <text>The provision of gratuitous care by self, family, or friends;</text> </paragraph> <paragraph num="C."> <text>A nurse from delegating a nursing task to an unlicensed individual if acceptance of delegated nursing tasks does not become a routine part of the unlicensed individual’s job duties; or</text> </paragraph> <paragraph num="D."> <text>A cognitively capable adult from employing an unlicensed caregiver in the adult’s home to assist the adult in treatments of a routine nature and in self-administration of medication.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assessment” means a comprehensive, dynamic process by which the registered nurse collects and analyzes data through interaction with:</text> <paragraph num="(a)"> <text>The client;</text> </paragraph> <paragraph num="(b)"> <text>The family;</text> </paragraph> <paragraph num="(c)"> <text>Significant others; and</text> </paragraph> <paragraph num="(d)"> <text>Other health care providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Certified nursing assistant (CNA)” means an individual certified by the Board to practice as a nursing assistant.</text> </paragraph> <paragraph num="(3)"> <text>“Delegate” means the nurse:</text> <paragraph num="(a)"> <text>Authorizes the CNA to act on behalf of the nurse;</text> </paragraph> <paragraph num="(b)"> <text>Authorizes the CNA to augment and supplement the care the nurse provides; and</text> </paragraph> <paragraph num="(c)"> <text>Retains the accountability and responsibility for the delegated act.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Health care team” means a group of individuals that includes licensed health care providers, CNAs, and unlicensed personnel working in collaboration with the client, family, and friends to achieve identified outcomes.</text> </paragraph> <paragraph num="(5)"> <text>“Health status data” means and includes, but is not limited to:</text> <paragraph num="(a)"> <text>Biophysical status to measure:</text> <paragraph num="(i)"> <text>Height;</text> </paragraph> <paragraph num="(ii)"> <text>Weight; and</text> </paragraph> <paragraph num="(iii)"> <text>Vital signs;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Cultural, religious, and socioeconomic background; and</text> </paragraph> <paragraph num="(c)"> <text>Activities of daily living.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Nurse” means a licensed registered nurse (RN) or a licensed practical nurse (LPN).</text> </paragraph> <paragraph num="(7)"> <text>“Nursing plan of care” means an established set of goals, priorities, and methods designed to solve, prevent, and manage a client’s identified problems.</text> </paragraph> <paragraph num="(8)"> <text>“Outcome” means a measurable, expected, client-focused goal which is observable by the client’s behavior or status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope of Practice."> <paragraph num="A."> <text>Responsibility.</text> <paragraph num="(1)"> <text>A CNA:</text> <paragraph num="(a)"> <text>Works under the delegated authority from a nurse to perform a nursing function;</text> </paragraph> <paragraph num="(b)"> <text>Assists the nurse in collecting data for a nursing assessment; and</text> </paragraph> <paragraph num="(c)"> <text>Is under the supervision of a nurse.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In a team relationship with a registered nurse, and under the instruction, direction, and supervision of a nurse, the CNA shall:</text> <paragraph num="(a)"> <text>Collect and record routine health data identified by the nurse on assigned clients;</text> </paragraph> <paragraph num="(b)"> <text>Orally report the health status data as required by the nurse;</text> </paragraph> <paragraph num="(c)"> <text>Identify when the client’s condition or behavior has changed from one day to another or from one part of the assigned shift to another and report any change to the nurse;</text> </paragraph> <paragraph num="(d)"> <text>Provide feedback to the nurse regarding the nurse-directed plan of care which is being implemented;</text> </paragraph> <paragraph num="(e)"> <text>Provide feedback to the nurse about the client’s expressed wishes concerning the plan of care;</text> </paragraph> <paragraph num="(f)"> <text>Provide assistance with activities of daily living as delegated by the nurse;</text> </paragraph> <paragraph num="(g)"> <text>Perform interventions as delegated by a registered nurse;</text> </paragraph> <paragraph num="(h)"> <text>Record routine data and care provided on appropriate documents;</text> </paragraph> <paragraph num="(i)"> <text>Identify the need for assistance and request assistance when the CNA:</text> <paragraph num="(i)"> <text>Is unsure about a client’s condition;</text> </paragraph> <paragraph num="(ii)"> <text>Does not know how to do an activity;</text> </paragraph> <paragraph num="(iii)"> <text>Is aware that client circumstances have changed;</text> </paragraph> <paragraph num="(iv)"> <text>Is working in a new practice or work setting; or</text> </paragraph> <paragraph num="(v)"> <text>Is working with a new client in an unfamiliar situation;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Report the client’s response and the client’s progress to the nurse:</text> <paragraph num="(i)"> <text>At designated times; and</text> </paragraph> <paragraph num="(ii)"> <text>When client circumstances have changed;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Make suggestions or recommendations on how the nursing plan of care can be modified based on observations of the client’s performance and statements; and</text> </paragraph> <paragraph num="(l)"> <text>Demonstrate competency in safely performing CNA functions, which include, but are not limited to:</text> <paragraph num="(i)"> <text>Participation in quality of care activities;</text> </paragraph> <paragraph num="(ii)"> <text>Performance self-appraisal;</text> </paragraph> <paragraph num="(iii)"> <text>Continued learning;</text> </paragraph> <paragraph num="(iv)"> <text>Collaboration;</text> </paragraph> <paragraph num="(v)"> <text>Completion of delegated assignments; and</text> </paragraph> <paragraph num="(vi)"> <text>Refusing or accepting an assignment based on one’s knowledge or experience.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Confidentiality. The CNA shall:</text> <paragraph num="(1)"> <text>Adhere to local, State, and federal guidelines and regulations regarding client confidentiality and privacy rights; and</text> </paragraph> <paragraph num="(2)"> <text>Direct all client requests for information to a nurse.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Advocacy. The CNA shall:</text> <paragraph num="(1)"> <text>Advocate for the client by reporting to the nurse statements expressed by the client or family regarding:</text> <paragraph num="(a)"> <text>Any request for information;</text> </paragraph> <paragraph num="(b)"> <text>Concerns about care; and</text> </paragraph> <paragraph num="(c)"> <text>Client needs; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Collaborate with other health care team members by reporting information and data regarding the client in a timely, truthful, and complete manner.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Teaching. The CNA shall:</text> <paragraph num="(1)"> <text>Reinforce the nurse’s health teaching:</text> <paragraph num="(a)"> <text>In accordance with the:</text> <paragraph num="(i)"> <text>Facility;</text> </paragraph> <paragraph num="(ii)"> <text>Employer; or</text> </paragraph> <paragraph num="(iii)"> <text>Agency policy; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>At the direction of the registered nurse’s written instruction;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Report the client’s response to the teaching; and</text> </paragraph> <paragraph num="(3)"> <text>Report any request by the client for additional information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Accountability. The CNA shall:</text> <paragraph num="(1)"> <text>Comply with all policies and procedures of the:</text> <paragraph num="(a)"> <text>Facility;</text> </paragraph> <paragraph num="(b)"> <text>Employer; and</text> </paragraph> <paragraph num="(c)"> <text>Agency;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comply with all local, State, and federal guidelines and regulations governing nursing assistant practice;</text> </paragraph> <paragraph num="(3)"> <text>Perform competently all activities as assigned or delegated;</text> </paragraph> <paragraph num="(4)"> <text>Report to the nurse;</text> </paragraph> <paragraph num="(5)"> <text>Provide the client with a safe therapeutic environment;</text> </paragraph> <paragraph num="(6)"> <text>Recognize the CNA’s individual limits of knowledge and experience;</text> </paragraph> <paragraph num="(7)"> <text>As needed, request assistance, direction, and supervision from the nurse;</text> </paragraph> <paragraph num="(8)"> <text>Recognize the CNA’s responsibility and accountability to perform functions safely and competently;</text> </paragraph> <paragraph num="(9)"> <text>Comply with the CNA code of ethics in accordance with COMAR 10.39.07;</text> </paragraph> <paragraph num="(10)"> <text>Report all errors, omissions, or incidents which may have occurred during the CNA’s own practice or the practice of others; and</text> </paragraph> <paragraph num="(11)"> <text>Follow the basic principle of nursing practice: “First, do no harm to the client”.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1) and (2) and 8-6A-05(a)(1), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 15, 2010 (37:23 Md. R. 1611)</annotation> </annotations> </chapter> <chapter num="06" heading="Certified Dialysis Technicians"> <regulation prefix="Regulation" num=".01" heading="Exceptions."> <text>This chapter does not apply to an individual who:</text> <paragraph num="A."> <text>Practices a health occupation, other than certified dialysis technician, that the individual is authorized to practice in accordance with Health Occupations Article, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Provides for the gratuitous care of friends, domestic partners, or family members;</text> </paragraph> <paragraph num="C."> <text>Performs dialysis technician tasks as a student while under the direct supervision of qualified faculty;</text> </paragraph> <paragraph num="D."> <text>Performs nursing tasks delegated by a registered nurse or licensed practical nurse so long as the delegated nursing tasks do not become a routine part of the unlicensed or uncertified individual’s job duties; and</text> </paragraph> <paragraph num="E."> <text>Is an unlicensed caregiver hired by a cognitively capable adult to assist the individual at their home in treatments of a routine nature and in self-administration of medication.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accountability” means being answerable for actions of self or others.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Central Repository” means the Maryland Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(4)"> <text>“Certificate” means a certificate issued by the Board to practice as a certified dialysis technician in this State.</text> </paragraph> <paragraph num="(5)"> <text>Certified Dialysis Technician (CDT).</text> <paragraph num="(a)"> <text>“Certified dialysis technician” means an individual who is certified by the Board to practice as a dialysis technician.</text> </paragraph> <paragraph num="(b)"> <text>“Certified dialysis technician” does not include a:</text> <paragraph num="(i)"> <text>Medication technician; or</text> </paragraph> <paragraph num="(ii)"> <text>Certified nursing assistant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Certified nursing assistant (CNA)” means an individual certified by the Board as a nursing assistant in accordance with COMAR 10.39.01.</text> </paragraph> <paragraph num="(7)"> <text>“Clinical facility” means a setting where patients are present and that provides facilities for supervised clinical training.</text> </paragraph> <paragraph num="(8)"> <text>“Criminal history records check (CHRC)” means the performance of both a State criminal history records check by the Central Repository and a national criminal history records check performed by the Federal Bureau of Investigation.</text> </paragraph> <paragraph num="(9)"> <text>“Criminal history record information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, convictions, and other dispositions of criminal charges.</text> </paragraph> <paragraph num="(10)"> <text>“Delegation” means the act of authorizing a certified dialysis technician to perform acts of registered nursing or licensed practical nursing.</text> </paragraph> <paragraph num="(11)"> <text>“Direct supervision” means the individual is on site, physically present, accessible in the immediate patient care area, and available to intervene if necessary.</text> </paragraph> <paragraph num="(12)"> <text>“Evaluation” means the review and analysis of the extent to which the assessment, nursing diagnosis, planning, and implementation phases of the nursing process were effective in resolving the patient’s identified problems.</text> </paragraph> <paragraph num="(13)"> <text>“Family” means related family members, foster parents, domestic partners, and legal guardians.</text> </paragraph> <paragraph num="(14)"> <text>“Good standing” means without an encumbrance that limits or restricts practice, such as revocation, suspension, or probation.</text> </paragraph> <paragraph num="(15)"> <text>“Licensed practical nurse (LPN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice licensed practical nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice licensed practical nursing.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Licensed Practitioner.</text> <paragraph num="(a)"> <text>“Licensed practitioner” means an individual licensed in the healthcare field.</text> </paragraph> <paragraph num="(b)"> <text>“Licensed practitioner” includes RNs, LPNs, advanced practice registered nurses, physicians, physician’s assistants, physical therapists, and respiratory therapists.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Model of Nursing Practice.</text> <paragraph num="(a)"> <text>“Model of nursing practice” means the policies, procedures, and practice guidelines:</text> <paragraph num="(i)"> <text>Established by the facility, which are consistent with this chapter regarding delegation of nursing functions and regulations governing the facility; and</text> </paragraph> <paragraph num="(ii)"> <text>That provide direction to nursing staff on the delivery of care to the patient population which the facility serves.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Model of nursing practice” may not supersede a delegating nurse’s prudent judgment regarding:</text> <paragraph num="(i)"> <text>Delegation of a nursing function to a dialysis technician; or</text> </paragraph> <paragraph num="(ii)"> <text>A particular delegated nursing function to that individual or individuals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B.</text> </paragraph> <paragraph num="(19)"> <text>“National certification” means certification as a:</text> <paragraph num="(a)"> <text>Certified Clinical Hemodialysis Technician issued by the Nephrology Nursing Certification Commission;</text> </paragraph> <paragraph num="(b)"> <text>Clinical Nephrology Technician issued by the National Nephrology Certification Organization; or</text> </paragraph> <paragraph num="(c)"> <text>Certified Hemodialysis Technician issued by the Board of Nephrology Examiners Nursing Technology.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Nurse” means a registered nurse or licensed practical nurse.</text> </paragraph> <paragraph num="(21)"> <text>“Patient” means the recipient of nursing care.</text> </paragraph> <paragraph num="(22)"> <text>“Practice as a certified dialysis technician” means to provide, under the supervision of a registered nurse or licensed practical nurse, direct care to patients undergoing renal dialysis treatments.</text> </paragraph> <paragraph num="(23)"> <text>“Program completion” means that the student:</text> <paragraph num="(a)"> <text>Completed and demonstrated competency in the program objectives and performance indicators during the didactic, laboratory, and clinical portions of the training program; and</text> </paragraph> <paragraph num="(b)"> <text>Passed the final written examination.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Qualified faculty” means an instructor or instructors as described in Regulation .10A of this chapter.</text> </paragraph> <paragraph num="(25)"> <text>“Readily available” means:</text> <paragraph num="(a)"> <text>The delegating nurse is physically present on the unit; and</text> </paragraph> <paragraph num="(b)"> <text>The nurse may transfer responsibility for the nursing supervision and delegation to another nurse who then becomes the nurse delegating the nursing functions.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Registered nurse (RN)” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed by the Board to practice registered nursing; or</text> </paragraph> <paragraph num="(b)"> <text>Has a multistate licensure privilege to practice registered nursing.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Routine care” means those activities necessary on a daily basis for the patient to gain or maintain a level of functioning.</text> </paragraph> <paragraph num="(28)"> <text>“Structured setting” means a dialysis facility, hospital, nursing home, long-term care facility, ambulatory care setting, or any other acute care, chronic care, or correctional facility that has a location in which dialysis care is provided.</text> </paragraph> <paragraph num="(29)"> <text>“Supervised clinical training” means training in person in a clinical facility during which the student demonstrates knowledge and skills while performing tasks on a patient under the direct supervision of an RN.</text> </paragraph> <paragraph num="(30)"> <text>“Supervision” means the process of critical watching, directing, and evaluating another's performance.</text> </paragraph> <paragraph num="(31)"> <text>“Unlicensed individual” means an individual who is not licensed or certified to provide nursing care in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Written agreement” means a contract between a training program and a clinical facility outlining the terms required, by both the program and the facility, for supervised clinical training of students.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Provisions for Applications."> <paragraph num="A."> <text>An applicant shall submit:</text> <paragraph num="(1)"> <text>A completed application to the Board on the form required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>To a CHRC in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Written evidence satisfactory to the Board that the applicant has submitted to a CHRC as required by §A(2) of this regulation by submitting:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the Federal Bureau of Investigation; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the Federal Bureau of Investigation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>Under §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>In an answer to a question on the Board's application form; or</text> </paragraph> <paragraph num="(c)"> <text>From any other source; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) of this regulation is incomplete or insufficient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to complete the application and provide all information and documents required in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board under §A of this regulation within 12 months from the date the application is received by the Board, then the application shall be considered abandoned and may be destroyed.</text> </paragraph> <paragraph num="D."> <text>Once an application is deemed abandoned under §C of this regulation, an individual seeking certification as a dialysis technician shall submit a new application on the form required by the Board and meet all the requirements for certification as a dialysis technician and pay the required fees that are in effect at the time of re-application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Certification."> <paragraph num="A."> <text>Initial certification. Except as provided in §D of this regulation, an applicant for initial certification as a dialysis technician shall have successfully completed a dialysis technician training program approved by the Board.</text> </paragraph> <paragraph num="B."> <text>Certification by Endorsement. An applicant for certification as a dialysis technician by endorsement shall:</text> <paragraph num="(1)"> <text>Hold a certificate to practice as a dialysis technician that:</text> <paragraph num="(a)"> <text>Was issued by another state or territory of the United States that has certification requirements that are essentially similar to those set forth in Health Occupations Article, §8-6A-05, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Is in good standing; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a dialysis technician training program that meets the standards for an approved dialysis technician training program set by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A certified dialysis technician shall obtain national dialysis technician certification within 18 months of the date of hire as a certified dialysis technician.</text> </paragraph> <paragraph num="D."> <text>An individual certified as a certified nursing assistant with the status of dialysis technician (CNA-DT) shall be deemed to meet the requirements for initial certification as a dialysis technician under §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application for Certification."> <paragraph num="A."> <text>Initial Certification.</text> <paragraph num="(1)"> <text>Except as otherwise provided in this chapter, an applicant for initial certification as a dialysis technician shall:</text> <paragraph num="(a)"> <text>Comply with all of the requirements under Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required fee to the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to the Board an application that has been signed by the administrator or faculty of the approved dialysis technician training program completed by the applicant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant shall submit an application for initial certification within 24 months of the date of completion of an approved dialysis technician training program.</text> </paragraph> <paragraph num="(3)"> <text>If an applicant fails to comply with §A(2) of this regulation, an applicant still seeking certification shall re-take an approved dialysis technician training program and comply with §A(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Certification by Endorsement. An applicant for certification as a dialysis technician by endorsement shall:</text> <paragraph num="(1)"> <text>Comply with all of the requirements under Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Pay the required fee to the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the following verifications directly to the Board from the appropriate authority:</text> <paragraph num="(a)"> <text>A certificate to practice as a dialysis technician in good standing from another state or territory with certification requirements that are essentially similar to the requirements in this State; and</text> </paragraph> <paragraph num="(b)"> <text>A certificate of completion from a dialysis technician training program in that state or territory that meets the standards for an approved dialysis technician training program set by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Temporary Practice Certificate."> <paragraph num="A."> <text>The Board may issue a temporary practice certificate to an applicant who:</text> <paragraph num="(1)"> <text>Has met the appropriate certification requirements to the satisfaction of the Board;</text> </paragraph> <paragraph num="(2)"> <text>Does not have a criminal record; and</text> </paragraph> <paragraph num="(3)"> <text>Has not been the subject of a health professional disciplinary action in this State or another jurisdiction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless the Board suspends or revokes a temporary practice certificate, the temporary practice certificate expires 90 days after the date of issuance.</text> </paragraph> <paragraph num="C."> <text>A temporary practice certificate may be extended up to an additional 90 days if the applicant is awaiting the completion of the criminal history records check.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Issuance of Certification."> <paragraph num="A."> <text>The Board may not issue a certificate to an applicant until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history record information of the applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless an applicant is subject to discipline, the Board shall issue a dialysis technician certificate to each applicant who meets all the requirements of this chapter and Health Occupations Article, §§8-6A-05 and 8-6A-06, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>CNA-DT Certificates.</text> <paragraph num="(1)"> <text>On or after the effective date of this regulation, the Board shall issue an initial dialysis technician certificate to all individuals then-certified as a CNA-DT.</text> </paragraph> <paragraph num="(2)"> <text>The status of an initial dialysis technician certificate issued pursuant to §C(1) of this regulation shall be the same as the status of the individual’s CNA-DT certificate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Expiration and Renewal of Certification."> <paragraph num="A."> <text>Expiration. Unless renewed for an additional 2-year term, and except as otherwise provided in this regulation, a certificate expires in accordance with the following schedule:</text> <paragraph num="(1)"> <text>The certificate of a certificate holder with an odd-numbered birth year expires on the 28th day of the certificate holder’s birth month in an odd-numbered year; and</text> </paragraph> <paragraph num="(2)"> <text>The certificate of a certificate holder with an even-numbered birth year expires on the 28th day of the certificate holder’s birth month in an even-numbered year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless an initial certificate is issued pursuant to Regulation .07C of this chapter, an initial dialysis technician certificate shall not expire within 180 days of the date of issuance.</text> </paragraph> <paragraph num="C."> <text>Certificate Holder Responsibility.</text> <paragraph num="(1)"> <text>It is the responsibility of the certificate holder to:</text> <paragraph num="(a)"> <text>Be aware of the expiration date of the certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Renew the certificate before it expires.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure of a certificate holder to receive the renewal notice sent by the Board does not relieve the certificate holder of the responsibility to renew a certificate before it expires.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Renewal Requirements.</text> <paragraph num="(1)"> <text>The Board shall renew a certificate if the certificate holder:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be certified;</text> </paragraph> <paragraph num="(b)"> <text>Submits a complete application for renewal on the form required by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Pays the renewal fee to the Board;</text> </paragraph> <paragraph num="(d)"> <text>Provides satisfactory evidence, as required by the Board, of:</text> <paragraph num="(i)"> <text>16 hours of active practice as a dialysis technician, for monetary compensation, in the last 24 months immediately preceding the date of expiration;</text> </paragraph> <paragraph num="(ii)"> <text>Completion of 3 hours of continuing education approved by the Board in the 24 months immediately preceding the date of expiration; and</text> </paragraph> <paragraph num="(iii)"> <text>Except as provided in §D(3) of this regulation, an active national certification; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If required to submit to a CHRC in accordance with §G of this regulation, complies with the requirements of Regulation .03A of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a renewal applicant cannot meet the requirements of §D(1)(d)(i)—(ii) of this regulation, the applicant shall re-take a Board-approved dialysis technician training program.</text> </paragraph> <paragraph num="(3)"> <text>If a renewal applicant is not yet eligible for a national certification before the first renewal, the applicant:</text> <paragraph num="(a)"> <text>May renew the certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Shall submit evidence of an active national certification at the next renewal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>National Certification.</text> <paragraph num="(1)"> <text>A dialysis technician shall not practice on an expired national certification.</text> </paragraph> <paragraph num="(2)"> <text>The dialysis technician shall submit a record of a renewed national certification to the Board if the national certification expires before renewal.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Continuing Education Courses.</text> <paragraph num="(1)"> <text>The Board may review and approve continuing education courses that provide didactic instruction in the principles and applications of dialysis.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall approve a course, seminar, or speaker session as a continuing education course if it is:</text> <paragraph num="(a)"> <text>Relevant to the practice of a dialysis technician; and</text> </paragraph> <paragraph num="(b)"> <text>Offered by a:</text> <paragraph num="(i)"> <text>College or university approved by the Maryland Higher Education Commission;</text> </paragraph> <paragraph num="(ii)"> <text>State or national professional dialysis association;</text> </paragraph> <paragraph num="(iii)"> <text>Board-approved certified dialysis technician program; or</text> </paragraph> <paragraph num="(iv)"> <text>Health department or hospital.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Course Review Requests.</text> <paragraph num="(a)"> <text>If a course does not meet the requirements under §F(2) of this regulation, a certified dialysis technician may request that the Board approve the course by submitting, in writing, at least 2 months before the course registration date, the following information on an application provided by the Board:</text> <paragraph num="(i)"> <text>Title, location, and date of the course;</text> </paragraph> <paragraph num="(ii)"> <text>Course sponsors;</text> </paragraph> <paragraph num="(iii)"> <text>Course objectives and contents;</text> </paragraph> <paragraph num="(iv)"> <text>Hours of study;</text> </paragraph> <paragraph num="(v)"> <text>Name, qualifications, and curriculum vitae of each presenter; and</text> </paragraph> <paragraph num="(vi)"> <text>The specific information that relates to the continuing education course.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Board shall notify the applicant of the Board's decision.</text> </paragraph> <paragraph num="(c)"> <text>A certified dialysis technician shall submit a course to the Board for reapproval if there is a change of subject matter, length, or presenter of a previously approved course.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Criminal History Records Checks. CHRCs for renewal applicants shall be scheduled according to the certificate holder’s birth month as follows:</text> <paragraph num="(1)"> <text>In 2025 — all applicants with an August or September birth month;</text> </paragraph> <paragraph num="(2)"> <text>In 2026 — all applicants with a September or October birth month;</text> </paragraph> <paragraph num="(3)"> <text>In 2027 — all applicants with an October or November birth month;</text> </paragraph> <paragraph num="(4)"> <text>In 2028 — all applicants with a November or December birth month;</text> </paragraph> <paragraph num="(5)"> <text>In 2029 — all applicants with a December or January birth month;</text> </paragraph> <paragraph num="(6)"> <text>In 2030 — all applicants with a January or February birth month;</text> </paragraph> <paragraph num="(7)"> <text>In 2031 — all applicants with a February or March birth month;</text> </paragraph> <paragraph num="(8)"> <text>In 2032 — all applicants with a March or April birth month;</text> </paragraph> <paragraph num="(9)"> <text>In 2033 — all applicants with an April or May birth month;</text> </paragraph> <paragraph num="(10)"> <text>In 2034 — all applicants with a May or June birth month;</text> </paragraph> <paragraph num="(11)"> <text>In 2035 — all applicants with a June or July birth month; and</text> </paragraph> <paragraph num="(12)"> <text>In 2036 — all applicants with a July or August birth month.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Training Program Approval."> <paragraph num="A."> <text>Approval.</text> <paragraph num="(1)"> <text>Before a training program is offered, the dialysis technician training program shall be approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>Board approval of a dialysis technician training program is valid for 2 years.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Procedure for Initial Approval.</text> <paragraph num="(1)"> <text>At least 90 days before the proposed start date of the program, a program provider seeking initial approval of a dialysis technician training program shall:</text> <paragraph num="(a)"> <text>Submit to the Board a complete application on the form required by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrate that the training program meets all the requirements of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Provide any additional information requested by the Board during the Board’s review of the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Board Action.</text> <paragraph num="(a)"> <text>Following receipt of a complete application, the Board’s professional staff may conduct a survey visit and submit a survey visit report to the Board.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall:</text> <paragraph num="(i)"> <text>Approve a training program that meets all the requirements of this regulation; or</text> </paragraph> <paragraph num="(ii)"> <text>Deny approval of a training program that does not meet all the requirements of this regulation.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Ongoing Responsibilities.</text> <paragraph num="(1)"> <text>Board Approval of Substantial Program Changes.</text> <paragraph num="(a)"> <text>An approved dialysis technician training program shall obtain approval from the Board before making any substantial changes to the program.</text> </paragraph> <paragraph num="(b)"> <text>Substantial program changes include:</text> <paragraph num="(i)"> <text>Changes to faculty;</text> </paragraph> <paragraph num="(ii)"> <text>Significant changes to curriculum, including an increase or decrease in program hours and changes to the modality of teaching; and</text> </paragraph> <paragraph num="(iii)"> <text>Removal or addition of clinical facilities or classroom locations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An approved training program shall submit to the Board an annual report, on the form required by the Board, that includes:</text> <paragraph num="(a)"> <text>Statistics on enrollments;</text> </paragraph> <paragraph num="(b)"> <text>Program completions; and</text> </paragraph> <paragraph num="(c)"> <text>Attrition rates.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may make survey visits from time to time, without prior notice, to all approved dialysis technician training programs.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Renewal of Approval.</text> <paragraph num="(1)"> <text>Expiration. Unless renewed, Board approval of a training program expires 2 years from the last date of approval.</text> </paragraph> <paragraph num="(2)"> <text>Renewal application. At least 90 days before the date of expiration of approval, an approved training program applying for renewal shall submit:</text> <paragraph num="(a)"> <text>A complete application on the form required by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>All accompanying documentation required by the application or requested by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Survey visit. Following receipt of a renewal application, the Board’s professional staff may conduct an announced or unannounced on-site survey visit and submit a survey visit report to the Board.</text> </paragraph> <paragraph num="(4)"> <text>Board Action. The Board shall:</text> <paragraph num="(a)"> <text>Renew approval of a training program for another 2-year term if the training program meets the requirements of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Initiate withdrawal proceedings in accordance with §E of this regulation if the training program fails to meet the requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Enrollment. A training program that fails to renew its approval:</text> <paragraph num="(a)"> <text>Shall be listed on nonrenewed status in the Board’s records; and</text> </paragraph> <paragraph num="(b)"> <text>May not enroll any new students to the program following the expiration of approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Withdrawal of Approval.</text> <paragraph num="(1)"> <text>Notice of Deficiencies.</text> <paragraph num="(a)"> <text>If the Board determines that there is a basis for withdrawal of approval under §E(3) of this regulation, the Board shall issue a written notice of deficiencies to the training program.</text> </paragraph> <paragraph num="(b)"> <text>The notice of deficiencies shall notify the training program of the:</text> <paragraph num="(i)"> <text>Requirements with which the program has not complied;</text> </paragraph> <paragraph num="(ii)"> <text>Reasons for the Board’s determination; and</text> </paragraph> <paragraph num="(iii)"> <text>Requirement to submit a written plan of correction in accordance with §E(2) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Plan of Correction.</text> <paragraph num="(a)"> <text>A training program shall submit a written plan of correction within 30 days of the date of the notice of deficiencies unless granted an extension by the Board for good cause.</text> </paragraph> <paragraph num="(b)"> <text>The written plan of correction shall:</text> <paragraph num="(i)"> <text>Address all deficiencies noted by the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>Include dates of completion for correcting the deficiencies.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Board shall review the plan of correction and may approve or modify the dates of completion for correcting deficiencies.</text> </paragraph> <paragraph num="(d)"> <text>The training program shall correct the deficiencies within the time frame approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Grounds for withdrawal. The Board may withdraw approval of a training program that:</text> <paragraph num="(a)"> <text>Fails to comply with any of the requirements of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Fails to correct deficiencies within the time frame approved by the Board; or</text> </paragraph> <paragraph num="(c)"> <text>Enrolls new students after expiration of approval.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Procedure for Withdrawal.</text> <paragraph num="(a)"> <text>Before withdrawing approval of a training program, the Board shall:</text> <paragraph num="(i)"> <text>Notify the program of its intent to withdraw approval; and</text> </paragraph> <paragraph num="(ii)"> <text>Give the program an opportunity to request an evidentiary hearing before the Board.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The notice of intent to withdraw approval and hearing shall comply with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Reinstatement. A dialysis technician training program whose approval was withdrawn may apply for reinstatement of approval by submitting a reinstatement application demonstrating that the program meets all of the requirements of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Training Program Requirements."> <paragraph num="A."> <text>Faculty.</text> <paragraph num="(1)"> <text>The training program shall be administered by a registered nurse approved by the Board who meets the following qualifications:</text> <paragraph num="(a)"> <text>An active license to practice as a registered nurse in good standing in the State or a multistate licensure privilege to practice registered nursing in the State;</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 2 years of experience practicing as a registered nurse, of which at least 1 year was in the care of renal patients; and</text> </paragraph> <paragraph num="(c)"> <text>Education or experience in adult education in the form of:</text> <paragraph num="(i)"> <text>Experience as a staff development instructor for a minimum of 1 year;</text> </paragraph> <paragraph num="(ii)"> <text>Completion of at least 6 credit hours of an adult education program at a college or university; or</text> </paragraph> <paragraph num="(iii)"> <text>Completion of an adult education course approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The registered nurse who is responsible for administering the training program may utilize other licensed practitioners to assist in conducting classroom and clinical portions of the program in accordance with the professional’s educational background and applicable scope of practice.</text> </paragraph> <paragraph num="(3)"> <text>CDT Assistance.</text> <paragraph num="(a)"> <text>A certified dialysis technician may assist in aspects of supervised clinical training in a clinical facility, under the direct supervision of the registered nurse.</text> </paragraph> <paragraph num="(b)"> <text>A certified dialysis technician assisting in aspects of the training program shall:</text> <paragraph num="(i)"> <text>Hold a Certified Dialysis Technician certificate from the Board;</text> </paragraph> <paragraph num="(ii)"> <text>Possess a current national certification; and</text> </paragraph> <paragraph num="(iii)"> <text>Have at least 2 years' experience in hemodialysis services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The course instructor is responsible for:</text> <paragraph num="(a)"> <text>Participating in development and evaluation of the training program, including the acquisition of learning resources and instructional materials;</text> </paragraph> <paragraph num="(b)"> <text>Implementing the approved training program;</text> </paragraph> <paragraph num="(c)"> <text>Supervising classroom laboratory experiences;</text> </paragraph> <paragraph num="(d)"> <text>Evaluating student performance during didactic and laboratory training; and</text> </paragraph> <paragraph num="(e)"> <text>Providing direct supervision and clinical evaluation of each student at the clinical facility.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Facilities and Resources.</text> <paragraph num="(1)"> <text>Classroom, laboratory, and clinical facilities shall be approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>All instructional learning resources and materials shall:</text> <paragraph num="(a)"> <text>Be accessible and relevant to the role of a dialysis technician;</text> </paragraph> <paragraph num="(b)"> <text>Be written at a level appropriate for a dialysis technician; and</text> </paragraph> <paragraph num="(c)"> <text>Have a publication date not older than 5 years from the current year.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Clinical Facilities.</text> <paragraph num="(a)"> <text>Clinical facilities shall:</text> <paragraph num="(i)"> <text>Have a sufficient number and variety of patients to provide training experiences for all students to achieve the stated course objectives;</text> </paragraph> <paragraph num="(ii)"> <text>Have a sufficient number of RNs and other nursing personnel to ensure safe and continuous care of patients; and</text> </paragraph> <paragraph num="(iii)"> <text>Conform with accepted standards of nursing care and practice.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>There shall be a minimum of one course instructor for each eight students in the clinical area.</text> </paragraph> <paragraph num="(c)"> <text>Except for facility-based programs, the training program shall have a written agreement with a clinical facility that shall:</text> <paragraph num="(i)"> <text>Be developed jointly with the clinical facility and the training program;</text> </paragraph> <paragraph num="(ii)"> <text>Be reviewed periodically by the clinical facility and the training program;</text> </paragraph> <paragraph num="(iii)"> <text>Include a provision for adequate notice of termination;</text> </paragraph> <paragraph num="(iv)"> <text>Specify the responsibility of the training program to the clinical facility and the responsibility of the clinical facility to the training program; and</text> </paragraph> <paragraph num="(v)"> <text>Identify the functions and responsibilities of the parties involved.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Curriculum.</text> <paragraph num="(1)"> <text>A dialysis technician training program shall provide a minimum of 220 hours of instruction, of which a minimum of:</text> <paragraph num="(a)"> <text>80 hours shall be devoted to didactic instruction and classroom laboratory training; and</text> </paragraph> <paragraph num="(b)"> <text>140 hours shall be devoted to supervised clinical training in a clinical facility.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dialysis training program shall include curriculum content that ensures sufficient preparation for national certification and for safe and effective practice as a dialysis technician.</text> </paragraph> <paragraph num="(3)"> <text>Didactic instruction shall include the following content:</text> <paragraph num="(a)"> <text>Content required under 42 CFR §494.140E(3);</text> </paragraph> <paragraph num="(b)"> <text>A review of the relevant laws and regulations regarding the practice of a dialysis technician and appropriate program policies;</text> </paragraph> <paragraph num="(c)"> <text>Data collection;</text> </paragraph> <paragraph num="(d)"> <text>Environment;</text> </paragraph> <paragraph num="(e)"> <text>Renal anatomy and physiology;</text> </paragraph> <paragraph num="(f)"> <text>Infection control and universal precautions;</text> </paragraph> <paragraph num="(g)"> <text>Basic chemistry of body fluids and electrolytes;</text> </paragraph> <paragraph num="(h)"> <text>Manifestations of renal failure;</text> </paragraph> <paragraph num="(i)"> <text>Blood work and laboratory values related to dialysis;</text> </paragraph> <paragraph num="(j)"> <text>Principles of dialysis;</text> </paragraph> <paragraph num="(k)"> <text>Pharmacology of the drugs commonly used during dialysis;</text> </paragraph> <paragraph num="(l)"> <text>Medication administration techniques specific to the drugs used in dialysis, including lidocaine, heparin, and normal saline;</text> </paragraph> <paragraph num="(m)"> <text>Management of the complications of dialysis and renal failure;</text> </paragraph> <paragraph num="(n)"> <text>The role of the dialysis technician in a dialysis setting including, but not limited to, legal and ethical considerations and concepts of delegation;</text> </paragraph> <paragraph num="(o)"> <text>Water treatment relevant to dialysis;</text> </paragraph> <paragraph num="(p)"> <text>Principles of patient education related to renal failure;</text> </paragraph> <paragraph num="(q)"> <text>Principles of and requirements for documentation;</text> </paragraph> <paragraph num="(r)"> <text>Communication and teamwork skills, including:</text> <paragraph num="(i)"> <text>Observing, recording, and reporting;</text> </paragraph> <paragraph num="(ii)"> <text>Interpersonal skills; and</text> </paragraph> <paragraph num="(iii)"> <text>Listening;</text> </paragraph> </paragraph> <paragraph num="(s)"> <text>Operation of dialysis delivery systems that includes the machines, dialysate, and dialyzer;</text> </paragraph> <paragraph num="(t)"> <text>Principles of safe effective dialysis care;</text> </paragraph> <paragraph num="(u)"> <text>Principles related to the nutritional considerations for patients receiving dialysis;</text> </paragraph> <paragraph num="(v)"> <text>Psychosocial aspects of renal disease;</text> </paragraph> <paragraph num="(w)"> <text>Principles of dialyzer reprocessing;</text> </paragraph> <paragraph num="(x)"> <text>Principles for initiating, monitoring, and discontinuing dialysis;</text> </paragraph> <paragraph num="(y)"> <text>Principles related to the adequacy of dialysis; and</text> </paragraph> <paragraph num="(z)"> <text>Establishing and maintaining professional boundaries with a patient.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Clinical instruction shall:</text> <paragraph num="(a)"> <text>Provide the student with the opportunity to practice the cognitive, psychomotor, and affective skills required for the safe performance of dialysis care by the dialysis technician;</text> </paragraph> <paragraph num="(b)"> <text>Meet the learning needs of each student;</text> </paragraph> <paragraph num="(c)"> <text>Meet the established program objectives or outcomes; and</text> </paragraph> <paragraph num="(d)"> <text>Be provided concurrently with the related classroom theory instruction.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Each training program shall identify the unit objectives and performance indicators for each of the areas in §C(3) of this regulation in its training criteria.</text> </paragraph> <paragraph num="(6)"> <text>A training program shall provide at least 16 hours of didactic and classroom laboratory training before a trainee’s direct assignment to patient care. This instruction shall include the following topics:</text> <paragraph num="(a)"> <text>The role of the dialysis technician;</text> </paragraph> <paragraph num="(b)"> <text>Infection control;</text> </paragraph> <paragraph num="(c)"> <text>Safety and environment;</text> </paragraph> <paragraph num="(d)"> <text>Data collection;</text> </paragraph> <paragraph num="(e)"> <text>Treatments; and</text> </paragraph> <paragraph num="(f)"> <text>Laboratory procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Evaluation.</text> <paragraph num="(1)"> <text>Each training program shall have an objective final written examination that measures achievement of the performance indicators.</text> </paragraph> <paragraph num="(2)"> <text>To successfully complete the program, each student shall:</text> <paragraph num="(a)"> <text>Complete the required minimum hours provided in §C(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Achieve a passing score of at least 75 percent on the written final examination; and</text> </paragraph> <paragraph num="(c)"> <text>Demonstrate competence in meeting the objectives and performance indicators during didactic, laboratory, and clinical instruction.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The training program shall provide a certificate of completion, using the form required by the Board, to students upon program completion.</text> </paragraph> <paragraph num="(4)"> <text>An administrator or faculty of a training program:</text> <paragraph num="(a)"> <text>May sign a student’s application for certification as a dialysis technician before graduation; and</text> </paragraph> <paragraph num="(b)"> <text>Shall submit to the Board written verification, as required by the Board, of each student’s program completion within 5 business days of program completion.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Scope of Practice."> <paragraph num="A."> <text>Medication Administration.</text> <paragraph num="(1)"> <text>A certified dialysis technician shall administer only the following medications:</text> <paragraph num="(a)"> <text>Intradermal lidocaine or another single therapeutically equivalent local anesthetic for the purpose of initiating dialysis treatment;</text> </paragraph> <paragraph num="(b)"> <text>Intravenous heparin or other single therapeutically equivalent anti-coagulant for the purpose of initiating and maintaining dialysis treatment;</text> </paragraph> <paragraph num="(c)"> <text>Intravenous normal saline; and</text> </paragraph> <paragraph num="(d)"> <text>Oxygen, when the administration of the oxygen has been delegated to the certified dialysis technician by a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>When administering the medications set forth in §A(1) of this regulation, the certified dialysis technician shall:</text> <paragraph num="(a)"> <text>Ensure that the right dose of the right medication is given to the right individual through the right route of administration at the right time;</text> </paragraph> <paragraph num="(b)"> <text>Accurately and timely document the administration of the medication and notify a physician or licensed nurse of the patient’s response to the medication as appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Consult with an appropriate licensed practitioner when the certified dialysis technician believes or has reason to believe that a prescribed medication is inaccurate, not properly authorized, harmful or potentially harmful to a patient, or contraindicated by other documented information; and</text> </paragraph> <paragraph num="(d)"> <text>Take any other action needed to ensure the safety of the patient.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A certified dialysis technician shall administer the medications authorized under §A(1) of this regulation only if the task has been delegated to the dialysis technician by a registered nurse or licensed practical nurse in accordance with Regulations .11—.13 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>The certified dialysis technician shall be under the direct supervision of a registered nurse or licensed practical nurse when administering medications.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Practice Standards.</text> <paragraph num="(1)"> <text>A certified dialysis technician shall provide dialysis care only when the performance of the care is delegated to the certified dialysis technician by a registered nurse or licensed practical nurse.</text> </paragraph> <paragraph num="(2)"> <text>A certified dialysis technician shall demonstrate competence and accountability in all areas of dialysis care in which the technician is engaged, including, but not limited to, the following:</text> <paragraph num="(a)"> <text>Consistent performance of all aspects of dialysis care according to acceptable standards; and</text> </paragraph> <paragraph num="(b)"> <text>Appropriate recognition, referral, consultation, or intervention when a complication arises in conjunction with dialysis or when a change in patient status occurs.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A certified dialysis technician shall timely:</text> <paragraph num="(a)"> <text>Implement the prescribed dialysis care order for a patient unless the technician believes or should have reason to believe that the prescribed order is inaccurate, not properly authorized, not current or valid, harmful or potentially harmful to the patient, or contraindicated by other documented information; and</text> </paragraph> <paragraph num="(b)"> <text>Clarify any prescribed dialysis care order for a patient when the technician believes or should have reason to believe that the order is inaccurate, not properly authorized, not current or valid, harmful or potentially harmful to the patient, or contraindicated by other documented information.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>When clarifying the prescribed dialysis care order, the certified dialysis technician shall timely:</text> <paragraph num="(a)"> <text>Consult with an appropriate licensed practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Notify the delegating nurse when the technician believes that it would not be appropriate to follow the prescribed dialysis care order;</text> </paragraph> <paragraph num="(c)"> <text>Document:</text> <paragraph num="(i)"> <text>That the delegating nurse was notified;</text> </paragraph> <paragraph num="(ii)"> <text>The outcome of the consultation with the delegating nurse; and</text> </paragraph> <paragraph num="(iii)"> <text>The treatment plan for the patient; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Take any other action needed to ensure the safety of the patient.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A dialysis technician shall timely report to and consult as necessary with other members of the dialysis care team, including, but not limited to, the licensed nurse or physician when a patient refuses to follow the prescribed dialysis care order.</text> </paragraph> <paragraph num="(6)"> <text>A dialysis technician shall comply with the code of ethics for certificate holders set forth in COMAR 10.39.07.</text> </paragraph> <paragraph num="(7)"> <text>A dialysis technician shall do the following to promote patient safety:</text> <paragraph num="(a)"> <text>Display the applicable CDT title or initials at all times when providing dialysis care;</text> </paragraph> <paragraph num="(b)"> <text>Completely, accurately, and timely document and report all patient data obtained while providing dialysis care and the patient’s response to the care;</text> </paragraph> <paragraph num="(c)"> <text>Completely, accurately, and timely document and report to the appropriate practitioner all errors in or deviations from the prescribed dialysis care regimen;</text> </paragraph> <paragraph num="(d)"> <text>Not falsify any patient record or any other documents prepared in the course of or in conjunction with the provision of dialysis care. This includes, but is not limited to, case management documents or reports, time records or reports, and other documents related to billing for dialysis services; and</text> </paragraph> <paragraph num="(e)"> <text>Implement measures to provide a safe environment for the patient.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A dialysis technician shall only work in a structured setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Criteria for Delegation."> <paragraph num="A."> <text>The nurse may delegate the responsibility to perform a dialysis-related nursing task to a certified dialysis technician. The delegating nurse retains the accountability for the dialysis-related nursing task.</text> </paragraph> <paragraph num="B."> <text>A dialysis-related nursing task delegated by the nurse shall be:</text> <paragraph num="(1)"> <text>Within the area of responsibility of the nurse delegating the act;</text> </paragraph> <paragraph num="(2)"> <text>Such that, in the judgment of the nurse, it can be properly and safely performed by the certified dialysis technician without jeopardizing patient welfare; and</text> </paragraph> <paragraph num="(3)"> <text>A task that a reasonable and prudent nurse would find is within the scope of sound nursing judgment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dialysis-related nursing task delegated by the nurse may not require the certified dialysis technician to exercise nursing judgment or intervention except in an emergency situation.</text> </paragraph> <paragraph num="D."> <text>When delegating a dialysis-related nursing task to a certified dialysis technician, the nurse shall:</text> <paragraph num="(1)"> <text>Make an assessment of the patient's nursing care needs related to the delegated task;</text> </paragraph> <paragraph num="(2)"> <text>Either instruct the certified dialysis technician in the delegated task or verify the certified dialysis technician's competency to perform the nursing task;</text> </paragraph> <paragraph num="(3)"> <text>Supervise the performance of the delegated nursing task in accordance with Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Be accountable and responsible for the delegated task;</text> </paragraph> <paragraph num="(5)"> <text>Evaluate the performance of the delegated nursing task; and</text> </paragraph> <paragraph num="(6)"> <text>Be responsible for ensuring accurate documentation of outcomes on the medical record.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The nurse shall be the primary decision maker when delegating a dialysis-related nursing task to a certified dialysis technician. Nursing judgment shall be exercised within the context of the employer’s model of nursing practice which includes a mechanism for:</text> <paragraph num="(1)"> <text>Identifying those individuals to whom nursing tasks may be delegated;</text> </paragraph> <paragraph num="(2)"> <text>Reevaluation of the competency of those to whom nursing tasks may be delegated;</text> </paragraph> <paragraph num="(3)"> <text>Recognizing that the final decision regarding delegation is within the scope of the nurse's professional judgment;</text> </paragraph> <paragraph num="(4)"> <text>Determining the competency of the nurse to delegate; and</text> </paragraph> <paragraph num="(5)"> <text>Determining to whom nursing tasks may be delegated, which includes input by nurses employed in the structured setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Supervision of Delegated Nursing Tasks."> <paragraph num="A."> <text>Except as provided in §B(2) of this regulation, the nurse shall determine the required degree of supervision after an evaluation of appropriate factors including, but not limited to, the:</text> <paragraph num="(1)"> <text>Stability of the condition of the patient;</text> </paragraph> <paragraph num="(2)"> <text>Training of the individual to whom the nursing task is being delegated;</text> </paragraph> <paragraph num="(3)"> <text>Nature of the nursing task being delegated;</text> </paragraph> <paragraph num="(4)"> <text>Orientation of the certified dialysis technician to the specific patient environment;</text> </paragraph> <paragraph num="(5)"> <text>Ability of the certified dialysis technician to perform the delegated nursing task in a safe and competent manner; and</text> </paragraph> <paragraph num="(6)"> <text>Reevaluation of the patient's health status.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The delegating nurse shall:</text> <paragraph num="(1)"> <text>Be readily available when delegating a nursing task to a certified dialysis technician; and</text> </paragraph> <paragraph num="(2)"> <text>Provide direct supervision of the certified dialysis technician when the certified dialysis technician is administering medications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Delegation of Nursing Functions."> <paragraph num="A."> <text>The following nursing functions require nursing knowledge, judgment, and skill and may not be delegated:</text> <paragraph num="(1)"> <text>The nursing assessment including, but not limited to, the admission, shift, transfer, or discharge assessment;</text> </paragraph> <paragraph num="(2)"> <text>Development of the nursing diagnosis;</text> </paragraph> <paragraph num="(3)"> <text>The establishment of the nursing care goal;</text> </paragraph> <paragraph num="(4)"> <text>Development of the nursing care plan;</text> </paragraph> <paragraph num="(5)"> <text>Evaluation of the patient's progress, or lack of progress, toward goal achievement; and</text> </paragraph> <paragraph num="(6)"> <text>Any nursing task which requires nursing knowledge, judgment, and skill.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nurse may delegate treatments of a routine nature if:</text> <paragraph num="(1)"> <text>The licensed nursing staff of the specific dialysis setting has identified the function as being routinely performed;</text> </paragraph> <paragraph num="(2)"> <text>The specific treatments are performed at a high frequency necessary to retain competency;</text> </paragraph> <paragraph num="(3)"> <text>The treatment has an inherently low risk to the patient, as determined by weighing the following factors:</text> <paragraph num="(a)"> <text>Type of equipment utilized to perform the function;</text> </paragraph> <paragraph num="(b)"> <text>Nurse staffing ratio that allows for close supervision;</text> </paragraph> <paragraph num="(c)"> <text>Basic educational preparation of the certified dialysis technician performing the delegated function; and</text> </paragraph> <paragraph num="(d)"> <text>Knowledge and skill set of the nurse delegating and supervising the delegated function; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>There is a quality assurance mechanism in place to ensure the function is performed safely and patient outcomes meet accepted professional nursing standards, including, but not limited to:</text> <paragraph num="(a)"> <text>An ongoing formalized documented performance appraisal mechanism designed to ensure that the certified dialysis technician’s revalidation of continued competency is a component of the quality assurance mechanism; and</text> </paragraph> <paragraph num="(b)"> <text>Patient outcomes meeting accepted professional standards, as reflected by:</text> <paragraph num="(i)"> <text>Infection rates;</text> </paragraph> <paragraph num="(ii)"> <text>Rates of adverse events;</text> </paragraph> <paragraph num="(iii)"> <text>Error rates; and</text> </paragraph> <paragraph num="(iv)"> <text>Patient satisfaction surveys.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The nurse may delegate the obtaining of specific information to a certified dialysis technician.</text> </paragraph> <paragraph num="D."> <text>When implementing the interdisciplinary plan of care, the nurse may delegate a nursing task to a certified dialysis technician when the delegation of that task does not jeopardize the patient's welfare.</text> </paragraph> <paragraph num="E."> <text>Administration of medication is a nursing function. As such, the nurse retains full responsibility for medication administration.</text> </paragraph> <paragraph num="F."> <text>The following activities related to medication administration may not be delegated except as provided in Regulation .11A(1) of this chapter:</text> <paragraph num="(1)"> <text>Calculation of any medication dose;</text> </paragraph> <paragraph num="(2)"> <text>Administration of medications by injection route;</text> </paragraph> <paragraph num="(3)"> <text>Administration of medications by way of a tube inserted in a cavity of the body; and</text> </paragraph> <paragraph num="(4)"> <text>Administration of medication by intravenous route.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Delegation of Medication Administration.</text> <paragraph num="(1)"> <text>The administration of medication may be delegated to certified dialysis technicians only in structured settings.</text> </paragraph> <paragraph num="(2)"> <text>A nurse may delegate the administration of only the medications set forth in Regulation .11A(1) of this chapter to a certified dialysis technician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Patient Health Teaching and Health Counseling."> <paragraph num="A."> <text>The registered nurse shall be accountable and responsible for the development and initiation of the health teaching plan and for health counseling of the patient.</text> </paragraph> <paragraph num="B."> <text>The nurse shall be accountable and responsible for facilitating and promoting:</text> <paragraph num="(1)"> <text>Patient education; and</text> </paragraph> <paragraph num="(2)"> <text>Participation of the patient and significant others in implementation of health goals.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certified dialysis technicians given instruction and direction by the nurse may supplement the health teaching by providing standardized information to the patient.</text> </paragraph> <paragraph num="D."> <text>The certified dialysis technician is responsible and accountable for reporting information to the nurse regarding the patient's:</text> <paragraph num="(1)"> <text>Request for information; and</text> </paragraph> <paragraph num="(2)"> <text>Response to teaching provided by the nurse or reinforcement provided by the certified dialysis technician.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§ 8-205, 8-303, 8-6A-01 through 8-6A-10, 8-6A-12, 8-6A-14.1, 8-6A-15, 8-701, 8-703, 8-705, and 8-706, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 4, 2025 (52:15 Md. R. 812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D, F amended effective April 27, 2026 (53:8 Md. R. 356)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G adopted effective April 27, 2026 (53:8 Md. R. 356)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective April 27, 2026 (53:8 Md. R. 356)</annotation> </annotations> </chapter> <chapter num="07" heading="Certificate Holders—Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abandonment.</text> <paragraph num="(a)"> <text>“Abandonment” means:</text> <paragraph num="(i)"> <text>Termination by a certificate holder of a client assignment that was accepted by the certificate holder, without reasonable notification to the immediate supervisor to allow for the continuation of the client's care;</text> </paragraph> <paragraph num="(ii)"> <text>Refusal by a certificate holder of an assignment, mandatory overtime, or both in the event of a natural disaster or a federal, State, county, or city declaration of an emergency; or</text> </paragraph> <paragraph num="(iii)"> <text>Failure of a certificate holder to report for assigned duty or leaving a client unattended at the end of the assigned shift if the certificate holder is the sole provider of care for a private duty or hospice assignment and does not provide prior notification to the nursing supervisor, the cognitively capable adult client, or the client's designated representative.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Abandonment” does not include the declining by a certificate holder of employer-stipulated mandatory overtime.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Accepting an assignment” means a certificate holder has arrived on duty and assumed responsibility for client care.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Certificate holder” means an individual who is certified by the Board as a certified nursing assistant in any category, a certified dialysis technician, or a medication technician.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means a patient, resident, or recipient of care.</text> </paragraph> <paragraph num="(6)"> <text>“Electronic devices” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephones with recording and picture-taking ability;</text> </paragraph> <paragraph num="(b)"> <text>Digital cameras or any other device that can record pictures and data;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machines, photocopiers, and scanners for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Recording devices.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Social media” means any form of electronic communication, including, but not limited to, communication by use of websites for social networking and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Responsibilities."> <paragraph num="A."> <text>A certificate holder shall:</text> <paragraph num="(1)"> <text>Respect the human dignity and uniqueness of a client and provide services unrestricted by consideration of social or economic status, religious affiliation, personal attributes, or the nature of health problems;</text> </paragraph> <paragraph num="(2)"> <text>Safeguard a client's right to privacy by maintaining confidentiality of information;</text> </paragraph> <paragraph num="(3)"> <text>Promptly report a breach of confidentiality or privacy;</text> </paragraph> <paragraph num="(4)"> <text>Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any individual;</text> </paragraph> <paragraph num="(5)"> <text>Assume responsibility and accountability for the individual certificate holder's judgments and actions;</text> </paragraph> <paragraph num="(6)"> <text>Maintain practice competence;</text> </paragraph> <paragraph num="(7)"> <text>Inform the Board of unethical conduct by another certificate holder;</text> </paragraph> <paragraph num="(8)"> <text>Demonstrate honesty and integrity in the performance of tasks, functions, and activities; and</text> </paragraph> <paragraph num="(9)"> <text>Perform nursing tasks, functions, and activities based on a certificate holder's education and training, and at the direction of the supervising nurse.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A certificate holder may not, when acting in the capacity or identity of a certificate holder:</text> <paragraph num="(1)"> <text>Abandon a client or assignment after assuming care for the client or accepting the assignment;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(3)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(4)"> <text>Assume duties and responsibilities without adequate preparation or maintaining competency; or</text> </paragraph> <paragraph num="(5)"> <text>Practice if unfit to perform procedures because of physical or mental impairment including, but not limited to, the effects of prescription drugs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A certificate holder may not engage in the following behaviors that dishonor the practice, whether or not acting in the capacity or identity of a certificate holder, including, but not limited to:</text> <paragraph num="(1)"> <text>Verbal abuse, including use of racial or ethnic slurs, directed toward a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(2)"> <text>Physically abusing, threatening, or intimidating a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(3)"> <text>Deceiving, defrauding, or stealing from a coworker, employer, client, or client's family member;</text> </paragraph> <paragraph num="(4)"> <text>Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication;</text> </paragraph> <paragraph num="(5)"> <text>Knowingly employing another individual to practice or engage in or attempt to practice or engage in an occupation or profession licensed under this title if the employee is not licensed to do so under Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Obtaining or copying any part of a client's health record;</text> </paragraph> <paragraph num="(7)"> <text>Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid medical indication;</text> </paragraph> <paragraph num="(8)"> <text>Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample;</text> </paragraph> <paragraph num="(9)"> <text>Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug;</text> </paragraph> <paragraph num="(10)"> <text>Using the power, influence, or knowledge obtained during the certificate holder’s relationship with the client for the certificate holder’s personal gratification or benefit;</text> </paragraph> <paragraph num="(11)"> <text>Performing acts beyond the scope of practice for which the individual is certified, unless acting in accordance with COMAR 10.27.11;</text> </paragraph> <paragraph num="(12)"> <text>Engaging in unprofessional or immoral conduct;</text> </paragraph> <paragraph num="(13)"> <text>Misrepresenting or concealing a material fact in obtaining a certificate, renewing a certificate, or reinstating a certificate;</text> </paragraph> <paragraph num="(14)"> <text>Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action; or</text> </paragraph> <paragraph num="(15)"> <text>Arranging or permitting another certificate holder or unlicensed person to replace the certificate holder or utilize the certificate holder's certificate to provide care to a client.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A certificate holder may not engage in sexual misconduct including, but not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client during the performance of a procedure or service for the client, regardless of the setting in which the service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client under any pretext of therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client;</text> </paragraph> <paragraph num="(4)"> <text>Sexual advances toward, or requesting sexual favors from, a coworker, student, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(5)"> <text>Discussion of sexual matters while caring for a client;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs of a client for a sexual purpose or personal gratification;</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of a coworker, student, employer, client, or client's family member;</text> </paragraph> <paragraph num="(8)"> <text>Sexual contact with an incompetent or unconscious client;</text> </paragraph> <paragraph num="(9)"> <text>Intentionally exposing any of the certificate holder's sexual body parts; and</text> </paragraph> <paragraph num="(10)"> <text>Intentionally exposing any of the client's sexual body parts for a nontherapeutic purpose.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Electronic devices, including but not limited to telephones, may not be used to record medical records and take pictures or videos of clients without written client authorization.</text> </paragraph> <paragraph num="F."> <text>A certificate holder:</text> <paragraph num="(1)"> <text>May not make use of electronic devices and social media to transmit or place any client information online; and</text> </paragraph> <paragraph num="(2)"> <text>Shall adhere to the following principles for the use of social media:</text> <paragraph num="(a)"> <text>Every certificate holder has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking;</text> </paragraph> <paragraph num="(b)"> <text>Certificate holders are bound to observe ethically prescribed client-certificate holder boundaries online as in any other setting;</text> </paragraph> <paragraph num="(c)"> <text>Client information shall be maintained in separate encrypted and secure files on personal computers and online;</text> </paragraph> <paragraph num="(d)"> <text>A certificate holder has an obligation to report any content that could harm a client’s privacy rights; and</text> </paragraph> <paragraph num="(e)"> <text>The standards of professionalism are the same when using electronic devices and social media as in any other circumstance.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of this chapter may result in the Board taking disciplinary action against a certificate holder pursuant to Health Occupations Article, §8-6A-10, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6A-01, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 11, 2014 (41:24 Md. R. 1428); August 4, 2025 (52:15 Md. R. 812)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 11, 2014 (41:24 Md. R. 1428)</annotation> </annotations> </chapter> </subtitle> <subtitle num="40" heading="Board of Podiatric Medical Examiners"> <chapter num="01" heading="Examination and Post-Graduate Training"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Maryland Board Examination” means the test administered by the Maryland State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Maryland Licensing Examination” means the test the Maryland State Board of Podiatric Medical Examiners administers to applicants for licensure.</text> </paragraph> <paragraph num="(4)"> <text>“National Board Examination” means the American Podiatric Medical Licensure Examinations administered by the National Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(5)"> <text>“Practiced podiatry actively” means for the immediately preceding 5 years has been actively engaged in the practice of podiatric medicine for at least 400 hours on average per year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Examinations."> <paragraph num="A."> <text>Only graduates of podiatric medical colleges which at the time of the applicant's graduation had standards equivalent to the standards for colleges approved by the Council on Education of the American Podiatric Medical Association are eligible for examination.</text> </paragraph> <paragraph num="B."> <text>The Board requires the following examinations for licensure:</text> <paragraph num="(1)"> <text>The National Board Examinations, parts I, II, and III;</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Board Examination.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The examinations specified in §B(2) of this regulation may be prepared by the Board or by a recognized national or state testing or licensing agency, with the approval of the Board.</text> </paragraph> <paragraph num="D."> <text>On each of the National Board Examinations, an applicant shall obtain a passing score as set by the National Board of Podiatric Medical Examiners. This result is required in order to be eligible to take the Maryland Board Examination and, after that, to be licensed by the Board.</text> </paragraph> <paragraph num="E."> <text>On the Maryland Board Examination, an applicant shall obtain a passing score, as set by the Board.</text> </paragraph> <paragraph num="F."> <text>The examination shall be taken within 1 year of the date of the application.</text> </paragraph> <paragraph num="G."> <text>The Maryland Board Examination may include, but is not limited to, the following subject areas:</text> <paragraph num="(1)"> <text>Physiology;</text> </paragraph> <paragraph num="(2)"> <text>Pharmacology;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic techniques;</text> </paragraph> <paragraph num="(4)"> <text>Pathology;</text> </paragraph> <paragraph num="(5)"> <text>Patient management;</text> </paragraph> <paragraph num="(6)"> <text>Surgical procedures;</text> </paragraph> <paragraph num="(7)"> <text>Biomechanics;</text> </paragraph> <paragraph num="(8)"> <text>Dermatology;</text> </paragraph> <paragraph num="(9)"> <text>Orthopedics;</text> </paragraph> <paragraph num="(10)"> <text>Podopediatrics.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An individual found by the Board to have engaged in conduct which subverts or attempts to subvert the licensing examination may, at the discretion of the Board, have the results of his licensing examination withheld, or declared invalid, or both. In addition, an individual who has subverted or attempted to subvert the licensing examination may be found ineligible for future licensure following a determination that the individual lacks good moral character as required by Health Occupations Article, §16-302(b), Annotated Code of Maryland, or is guilty of a violation of Health Occupations Article, §16-311(a)(1), Annotated Code of Maryland. Conduct which subverts or attempts to subvert the licensing examination includes, but is not limited to:</text> <paragraph num="(1)"> <text>Conduct which violates the security of the examination materials, including but not limited to:</text> <paragraph num="(a)"> <text>Removing from the examination room any of the examination materials;</text> </paragraph> <paragraph num="(b)"> <text>Reproducing a portion of any past or future licensing examination;</text> </paragraph> <paragraph num="(c)"> <text>Aiding by any means in the reproduction of any portions of a past or future licensing examination; or</text> </paragraph> <paragraph num="(d)"> <text>Selling, distributing, buying, receiving, or having unauthorized possession of any portion of a future or current licensing examination;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Conduct which violates the standard of test administration, including, but not limited to:</text> <paragraph num="(a)"> <text>Communicating with any other examinee during the administration of the licensing examination;</text> </paragraph> <paragraph num="(b)"> <text>Copying answers from another examinee or permitting one's answers to be copied by another examinee during the administration of the licensing examination; or</text> </paragraph> <paragraph num="(c)"> <text>Having in one's possession during the administration of the licensing examination any books, notes, written or printed materials or data of any kind, other than the examination materials distributed;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Conduct which violates the credentialing process, including but not limited to:</text> <paragraph num="(a)"> <text>Falsifying or misrepresenting education credentials or other information required for admission to the licensing examination;</text> </paragraph> <paragraph num="(b)"> <text>Impersonating an examinee; or</text> </paragraph> <paragraph num="(c)"> <text>Having an impersonator take the licensing examination on one's behalf.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Applications."> <paragraph num="A."> <text>Applications should be filed not later than 30 days before the date of the examination.</text> </paragraph> <paragraph num="B."> <text>Application fees are not refundable or transferrable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Location of Exams."> <paragraph num="A."> <text>Board examinations may be given in any locality in the State as determined by the Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="B."> <text>The applicant will be notified of the location of the examination when his application is approved.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Post-Graduate Clinical Training."> <paragraph num="A."> <text>Except as otherwise provided in this regulation, an applicant who submits an application for a license after January 1, 1990 shall demonstrate satisfactory completion of 2 years in a post-graduate medical education program in podiatric medicine and surgery approved by the Council on Education of the American Podiatric Medical Association, or its successor, and approved by the Board, in order to be eligible for the examination.</text> </paragraph> <paragraph num="B."> <text>This regulation does not apply to applicants who apply for a limited license.</text> </paragraph> <paragraph num="C."> <text>The Board may waive the requirement of this regulation at the request of an applicant who has practiced podiatry actively in another state for at least 5 years immediately before applying for a license in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Speech Impairment."> <paragraph num="A."> <text>An applicant who claims a speech impairment shall submit a written request to the Board:</text> <paragraph num="(1)"> <text>With the applicant's initial licensure application; or</text> </paragraph> <paragraph num="(2)"> <text>Within 1 year of development of the impairment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board retains the right to waive the 1-year time limit.</text> </paragraph> <paragraph num="C."> <text>An applicant may claim a speech impairment only if:</text> <paragraph num="(1)"> <text>A speech impairment exists; and</text> </paragraph> <paragraph num="(2)"> <text>The Board:</text> <paragraph num="(a)"> <text>Was properly notified of the impairment at the time of initial licensure; or</text> </paragraph> <paragraph num="(b)"> <text>Determines that a medical or surgical event created the impairment after licensure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If an applicant has a properly claimed and documented speech impairment, the Board may grant or renew a license only if the applicant is able to effectively communicate with health care providers and patients.</text> </paragraph> <paragraph num="E."> <text>The Board recognizes the following as proof of the applicant's ability to communicate effectively:</text> <paragraph num="(1)"> <text>Documentation from:</text> <paragraph num="(a)"> <text>A speech-language pathologist who is currently licensed to practice speech pathology in the United States indicating that the applicant can communicate in a professionally competent manner with patients and other health care providers; or</text> </paragraph> <paragraph num="(b)"> <text>Three Maryland licensed podiatrists that attest to the fact that the applicant can communicate in a professionally competent manner with patients and other health care providers; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A personal hearing before the Board during which the applicant relays the manner in which the applicant would:</text> <paragraph num="(a)"> <text>Obtain a history;</text> </paragraph> <paragraph num="(b)"> <text>Conduct a physical examination;</text> </paragraph> <paragraph num="(c)"> <text>Order additional tests;</text> </paragraph> <paragraph num="(d)"> <text>Obtain consultations; and</text> </paragraph> <paragraph num="(e)"> <text>Relay the results of the examination and treatment plan to a patient.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-205(a)(1), 16-302(f), and 16-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 22, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 4, 1976 (3:3 Md. R. 150); October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 29, 1985 (12:15 Md. R. 1520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 5, 1990 (17:4 Md. R. 496); December 5, 1994 (21:24 Md. R. 1989)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 5, 1994 (21:24 Md. R. 1989)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A—D, G amended effective March 5, 1990 (17:4 Md. R. 496)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 5, 1990 (17:4 Md. R. 496)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective May 1, 1989 (16:8 Md. R. 910)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective October 18, 1999 (26:21 Md. R. 1630)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 3, 2017 (44:13 Md. R. 621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective July 2, 2018 (45:13 Md. R. 668)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensing and Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all podiatrists licensed to practice in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Credit hour” means 1 program hour.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Initial Licensing and License Renewal."> <paragraph num="A."> <text>Initial Licensing.</text> <paragraph num="(1)"> <text>To qualify for licensure, an applicant shall:</text> <paragraph num="(a)"> <text>Meet all of the requirements as identified in Health Occupations Article, §§16-302—16-305, Annotated Code of Maryland, including submit to a State and national criminal history records check in accordance with Health Occupations Article, §16-302.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Except as provided in §A(2) of this regulation, at the time of application, possess a current cardiopulmonary resuscitation (CPR) certification that was attained through completion of a Board-approved cardiopulmonary resuscitation (CPR) course that includes a hands-on practical component.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may waive, modify, or waive and modify the cardiopulmonary resuscitation (CPR) certification required in §A(1)(b) of this regulation if the applicant submits a written request and documentation that sufficiently demonstrates an extraordinary hardship.</text> </paragraph> <paragraph num="(3)"> <text>The Board may not issue a license if the criminal history record information required under Health Occupations Article, §16-302.1, Annotated Code of Maryland, has not been received.</text> </paragraph> </paragraph> <paragraph num="B."> <text>License Renewal.</text> <paragraph num="(1)"> <text>Biennial renewal of each practitioner's license is contingent upon the submission, upon request of the Board, of satisfactory proof of completion of the required number of credit hours of continuing education programs approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall establish the required number of credit hours. Except as set forth in §B(5) of this regulation, the required number of credit hours may not exceed 50 hours for 2 years.</text> </paragraph> <paragraph num="(3)"> <text>The Board may refuse to renew the license of any podiatrist who fails to comply with these regulations.</text> </paragraph> <paragraph num="(4)"> <text>The licensee shall earn the required number of credit hours on or before December 1 of the license renewal year.</text> </paragraph> <paragraph num="(5)"> <text>If by December 1 of the license renewal year, the licensee fails to earn the required number of credit hours, the licensee may request an extension of time until December 31 of the license renewal year to earn the required number of credit hours plus an additional number of credit hours as established by the Board. The Board at its discretion, upon good cause shown, may grant an extension of time up to or beyond December 31, and may impose a requirement that the licensee earn up to double the number of required credit hours still to be earned. For example, if on December 1 the licensee has earned only 40 of the 50 required credit hours, the licensee may be required to earn 20 credit hours to meet the continuing education requirement.</text> </paragraph> <paragraph num="(6)"> <text>To qualify for renewal, a licensee shall possess a current cardiopulmonary resuscitation (CPR) certification that was attained through completion of a Board-approved cardiopulmonary resuscitation (CPR) course that:</text> <paragraph num="(a)"> <text>Includes a hands-on practical component; and</text> </paragraph> <paragraph num="(b)"> <text>Is worth 3 credit hours.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The Board may waive, modify, or waive and modify the cardiopulmonary resuscitation (CPR) certification required in §B(6) of this regulation if:</text> <paragraph num="(a)"> <text>The licensee submits a written request and documentation that sufficiently demonstrates an extraordinary hardship; and</text> </paragraph> <paragraph num="(b)"> <text>The Board receives the licensee's request not later than October 1 of the license renewal year.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A licensee applying for renewal may earn 1 credit hour for every 5 hours of pro bono podiatric services provided and pre-approved by the Board on a case-by-case basis with a maximum of 5 credit hours per renewal cycle;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless granted a waiver by the Board in accordance with §B(7) of this regulation, a licensee may not allow the required cardiopulmonary resuscitation (CPR) certification to lapse at any time while licensed by the Board.</text> </paragraph> <paragraph num="D."> <text>Of the 50 credit hours required under §B(2) of this regulation:</text> <paragraph num="(1)"> <text>25 credit hours:</text> <paragraph num="(a)"> <text>Shall be completed in person or online;</text> </paragraph> <paragraph num="(b)"> <text>Shall be directly related to the practice of podiatric medicine; and</text> </paragraph> <paragraph num="(c)"> <text>May include:</text> <paragraph num="(i)"> <text>The cardiopulmonary resuscitation (CPR) certification required in §B(6) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>Attendance at programs offered at professional or scientific meetings of local, State, regional, national, or international professional or scientific organizations; or</text> </paragraph> <paragraph num="(iii)"> <text>Attendance at regularly scheduled Board meetings;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The additional required 25 credit hours may be completed:</text> <paragraph num="(a)"> <text>In person or online;</text> </paragraph> <paragraph num="(b)"> <text>Online; or</text> </paragraph> <paragraph num="(c)"> <text>Via other sources;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All credit hours shall be pre-approved by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>The Board may not accept a submission for continuing education credit of less than 0.5 hours.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Accreditation."> <paragraph num="A."> <text>Accreditation by the Board of continuing education programming will be based solely upon the content of the programs. These programs shall be directed toward improvement, advancement, and extension of professional skill and knowledge relating to the practice of podiatry.</text> </paragraph> <paragraph num="B."> <text>Upon review of program content by the Board, credit shall be approved for the following:</text> <paragraph num="(1)"> <text>Continuing education programs given by a college of podiatric medicine approved by the Council on Education of the American Podiatric Medical Association;</text> </paragraph> <paragraph num="(2)"> <text>Lectures and scheduled courses at national and regional meetings of the American Podiatric Medical Association;</text> </paragraph> <paragraph num="(3)"> <text>Continuing education programs given or arranged by the Education Committee of the Maryland Podiatric Medical Association.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon review of program content by the Board, credit may be approved for local, state, regional, or national continuing education courses including postgraduate studies, institutes, seminars, lectures, conferences, workshops, extension studies, home study, approved residency programs, or other forms of continuing education approved by the Board.</text> </paragraph> <paragraph num="D."> <text>After review of program content, the Board may withdraw its approval of a previously accredited program, and shall notify all attendant State practitioners of this action as soon as possible.</text> </paragraph> <paragraph num="E."> <text>Approved credits may be applied toward fulfillment of the continuing education requirement only in the renewal period in which they are earned.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Substantiation of Credits."> <paragraph num="A."> <text>It is the responsibility of each podiatrist to keep accurate records of attendance at approved continuing education programs and to substantiate those records for the current licensing period upon request. Each podiatrist shall maintain records of attendance for a 5-year period.</text> </paragraph> <paragraph num="B."> <text>The Board may at any time request that within 10 working days a podiatrist substantiate the credits earned by providing satisfactory proof of completion of approved continuing education programs.</text> </paragraph> <paragraph num="C."> <text>The licensee shall show satisfactory proof of completion of approved continuing education programs.</text> </paragraph> <paragraph num="D."> <text>The Board shall disallow the requested credits in question, if the licensee is unable to substantiate the required credit hours. The Board may not renew a license if the required continuing education criteria are not met as specified in §§B—C of this regulation. Violation of this regulation may result in revocation or suspension of license or the imposition of other appropriate sanctions.</text> </paragraph> <paragraph num="E."> <text>Willful submission of fraudulent information to the Board constitutes a violation of these regulations and may result in revocation or suspension of license or the imposition of other appropriate sanctions.</text> </paragraph> <paragraph num="F."> <text>The Board may verify any information received regarding content, certification, and completion of a continuing education program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Change of Credit Requirement."> <text>The Board, by majority vote, may vary the number of required credit hours, but except as set forth in Regulation .03E of this chapter, these may not exceed 50 hours every 2 years. The Board shall notify each podiatrist of the change at the time of renewal, which is effective in the year following that renewal, and remains in effect until further notice.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Reinstatement."> <paragraph num="A."> <text>This regulation applies to any practitioner who:</text> <paragraph num="(1)"> <text>Has been on inactive status; or</text> </paragraph> <paragraph num="(2)"> <text>Applies to the Board for reinstatement of the license and has failed to renew the license for one licensing cycle or a 2-year period, whichever is longer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A practitioner may obtain reinstatement by submitting the following:</text> <paragraph num="(1)"> <text>Evidence of completion of continuing education requirements equal to those required for the period during which the individual has not held an active license, if this requirement does not exceed 125 hours;</text> </paragraph> <paragraph num="(2)"> <text>A licensure affidavit;</text> </paragraph> <paragraph num="(3)"> <text>An acceptable response to an inquiry to the National Healthcare Integrity and Protection Data Bank;</text> </paragraph> <paragraph num="(4)"> <text>An acceptable history of malpractice cases;</text> </paragraph> <paragraph num="(5)"> <text>Proof of out-of-State practice preceding the request for reinstatement that is sufficient to demonstrate current clinical proficiency such as:</text> <paragraph num="(a)"> <text>De-identified billing records;</text> </paragraph> <paragraph num="(b)"> <text>Sworn affidavits from colleagues; or</text> </paragraph> <paragraph num="(c)"> <text>Activity log from a hospital or other appropriate agency;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Proof of passing the Jurisprudence Examination as administered by the Board within the last licensing cycle preceding the reinstatement application; and</text> </paragraph> <paragraph num="(7)"> <text>Reinstatement processing and licensure fees as set forth in COMAR 10.40.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Severability."> <text>If any provision of these regulations or its application to any person or circumstances is held invalid, this invalidity may not affect other provisions or applications of the regulation which can be given effect without the invalid provision or application, and to this end, the provisions of this regulation are declared severable.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-205(a), 16-301, 16-302(h), 16-302.1, 16-303(a), 16-307, 16-308, and 16-311(28), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 4, 1976 (3:3 Md. R. 150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 1, 2012 (39:19 Md. R. 1237)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 24, 1994 (21:21 Md. R. 1814); March 22, 2010 (37:6 Md. R. 478); October 1, 2012 (39:19 Md. R. 1237); November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 15, 1990 (17:20 Md. R. 2428); December 19, 2016 (43:25 Md. R. 1385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 24, 1983 (10:21 Md. R. 1902</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective August 3, 1977 (4:16 Md. R. 1213)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 15, 1990 (17:20 Md. R. 2428); April 14, 2003 (30:7 Md. R. 488); June 6, 2016 (43:11 Md. R. 634); November 13, 2023 (50:22 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective April 14, 2003 (30:7 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B and D amended effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 24, 1994 (21:21 Md. R. 1814); March 22, 2010 (37:6 Md. R. 478)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 3, 1977 (4:16 Md. R. 1213); October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 15, 1979 (6:12 Md. R. 1050); repealed effective May 15, 1981 (8:10 Md. R. 877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 15, 1990 (17:20 Md. R. 2428); October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective September 5, 1980 (7:18 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended and recodified to Regulation .07 effective October 15, 1990 (17:20 Md. R. 2428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 recodified to Regulation .08 effective October 15, 1990 (17:20 Md. R. 2428)</annotation> </annotations> </chapter> <chapter num="03" heading="Collection of Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all persons licensed as podiatrists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>License fees:</text> <paragraph num="(1)"> <text>Application fee . . . $50;</text> </paragraph> <paragraph num="(1-1)"> <text>Eligibility verification for PM Lexis examination . . . $50;</text> </paragraph> <paragraph num="(1-2)"> <text>Original license fee:</text> <paragraph num="(a)"> <text>January issue . . . $1,050;</text> </paragraph> <paragraph num="(b)"> <text>July issue . . . $850;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Limited license fee . . . $100;</text> </paragraph> <paragraph num="(3)"> <text>Inactive license fee (initial application) . . . $150;</text> </paragraph> </paragraph> <paragraph num="B."> <text>License renewal fees:</text> <paragraph num="(1)"> <text>Biennial license renewal fee (payable in $525 annual payments) . . . $1,050;</text> </paragraph> <paragraph num="(2)"> <text>Inactive license renewal fee (payable annually) . . . $50;</text> </paragraph> <paragraph num="(3)"> <text>Late renewal fee . . . $250;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement fees:</text> <paragraph num="(1)"> <text>Reinstatement of inactive license processing fee . . . $300;</text> </paragraph> <paragraph num="(2)"> <text>Reinstatement of expired license processing fee . . . $500;</text> </paragraph> <paragraph num="(3)"> <text>Reinstatement of inactive or expired license fees:</text> <paragraph num="(a)"> <text>January issue . . . $1,050;</text> </paragraph> <paragraph num="(b)"> <text>July issue . . . $850;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Other fees:</text> <paragraph num="(1)"> <text>Certification of license fee . . . $30;</text> </paragraph> <paragraph num="(2)"> <text>Duplicate license fee . . . $50;</text> </paragraph> <paragraph num="(3)"> <text>Registration of professional corporation fee . . . $100;</text> </paragraph> <paragraph num="(4)"> <text>Dispensing prescription drug permit fee (payable every 5 years) . . . $1,050 ($50 Board processing fee + $1,000 mandated Division of Drug Control inspection fee for permit to dispense prescription drugs);</text> </paragraph> <paragraph num="(5)"> <text>Penalty for failure to maintain correct address with the Board . . . $300;</text> </paragraph> <paragraph num="(6)"> <text>Roster of licensees fee . . . $500;</text> </paragraph> <paragraph num="(7)"> <text>Request for copy of public orders . . . $50;</text> </paragraph> </paragraph> <paragraph num="E."> <text>If an individual pays the original license fee under §A(1-2) of this regulation in a year of renewal, the Board shall charge one installment of the license renewal fee under §B(1) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Podiatric Medical Examiners. All licensees and applicants will be notified of the change.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§12-102.2 and 16-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 4, 1976 (3:3 Md. R. 150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 20, 1989 (16:3 Md. R. 344); February 3, 1992 (19:2 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653) (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 19, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective June 15, 1988 (15:14 Md. R. 1653); emergency status expired December 12, 1988</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective September 5, 1980 (7:18 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E—G adopted effective August 4, 1976 (3:16 Md. R. 852)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H adopted effective September 5, 1980 (7:18 Md. R. 1740)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I, J adopted effective February 3, 1992 (19:2 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 5, 1990 (17:4 Md. R. 496)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 14, 2003 (30:7 Md. R. 488); December 22, 2003 (30:25 Md. R. 1848); December 29, 2008 (35:26 Md. R. 2250)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective March 22, 2010 (37:6 Md. R. 478)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective February 5, 2001 (28:2 Md. R. 100)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective July 20, 2015 (42:14 Md. R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E adopted effective October 1, 2012 (39:19 Md. R. 1237)</annotation> </annotations> </chapter> <chapter num="04" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to licensed podiatrists in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Sexual Misconduct."> <paragraph num="A."> <text>A podiatrist may not engage in sexual misconduct.</text> </paragraph> <paragraph num="B."> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a patient in the context of a professional evaluation, treatment, procedure, or other service to the patient, regardless of the setting in which the professional service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a patient on the pretense of therapeutic intent of benefit;</text> </paragraph> <paragraph num="(3)"> <text>Sexual acts, sexual conduct, vaginal intercourse, or any genital contact, as defined in Criminal Law Article §3-301(e) — (g), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a patient;</text> </paragraph> <paragraph num="(5)"> <text>Sexual advances requesting sexual favors;</text> </paragraph> <paragraph num="(6)"> <text>Therapeutically inappropriate or intentional touching of a sexual nature;</text> </paragraph> <paragraph num="(7)"> <text>A verbal comment of a sexual nature;</text> </paragraph> <paragraph num="(8)"> <text>Physical contact of a sexual nature with a patient;</text> </paragraph> <paragraph num="(9)"> <text>Discussion of unnecessary sexual matters while treating a patient;</text> </paragraph> <paragraph num="(10)"> <text>The taking of photographs of patients for a sexual purpose;</text> </paragraph> <paragraph num="(11)"> <text>Sexual harassment of staff or students;</text> </paragraph> <paragraph num="(12)"> <text>An unnecessary sensual act or comment; or</text> </paragraph> <paragraph num="(13)"> <text>Sexual contact with an incompetent or unconscious patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of Regulation .02 of this chapter may result in the Board taking action to reprimand a licensee or place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $50,000.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 16-205, and 16-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 2, 2000 (27:19 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 22, 2003 (30:25 Md. R. 1848)</annotation> </annotations> </chapter> <chapter num="05" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Podiatric Medical Examiners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board’s case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference committee” means a committee composed of one or more members of the Board that makes recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(7)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of podiatry.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Charging document” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Podiatry Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth provisions of the Maryland Podiatry Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Complaint” means a written allegation received by the Board that a licensee may have violated the Maryland Podiatry Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Consent order” means a public record issued by the Board that is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(11)"> <text>“Contested case” means a proceeding conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(12)"> <text>“Disposition agreement” means a nonpublic agreement entered into with a licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(13)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may do by law.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Imperatively requires emergency action” means a finding by the Board that an emergency action be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(15)"> <text>“Informal action” means that the Board closes a case without taking formal disciplinary action or without issuing a final order, by imposing a disciplinary sanction consisting of a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment;</text> </paragraph> <paragraph num="(c)"> <text>Cease and desist letter; or</text> </paragraph> <paragraph num="(d)"> <text>Disposition agreement.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Investigation” means the gathering of information to assist the Board in determining if there is reasonable cause to charge a licensee with a violation of the Maryland Podiatry Act.</text> </paragraph> <paragraph num="(17)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing a case, if the Board believes a licensee has engaged in conduct that violates the Maryland Podiatry Act, admonishing the licensee not to repeat the conduct.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may include an agreement that the licensee perform certain conditions instead of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Letter of education” means informal action consisting of a nonpublic letter to a licensee:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Podiatry Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of podiatry.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the license to practice podiatry.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of surrender” may include conditions for the Board’s acceptance of the surrender as a resolution of the case.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Licensure” means permission to engage in the practice of podiatry which is evidenced by a license issued by the Board.</text> </paragraph> <paragraph num="(21)"> <text>“Maryland Podiatry Act” means Health Occupations Article, Title16, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, a change in licensure status, or some other benefit sought by the licensee.</text> </paragraph> <paragraph num="(23)"> <text>“Preliminary review” means the gathering of information to be used by the Board to determine if the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Podiatry Act.</text> </paragraph> <paragraph num="(24)"> <text>“Probation” means a sanction imposed by the Board in a public final order in which the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public under General Provisions Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(26)"> <text>“Recommended decision” means a nonpublic record issued to the Board by an administrative law judge that sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of them.</text> </paragraph> <paragraph num="(27)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member’s participation in a case.</text> </paragraph> <paragraph num="(28)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, that has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of the Maryland Podiatry Act;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential emergency suspension under State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Notified as to potential violation of Health Occupations Article, §16-501 or 16-502, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Revocation” means the removal of a podiatrist’s license to practice podiatry.</text> </paragraph> <paragraph num="(30)"> <text>“Sanction” means an action by the Board, including a:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Placement on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fine; or</text> </paragraph> <paragraph num="(d)"> <text>Suspension or revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Show cause hearing” means a nonevidentiary hearing before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board may take.</text> </paragraph> <paragraph num="(32)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, taken if the Board believes the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(33)"> <text>“Surrender” means the voluntary relinquishing of a license to practice podiatry that may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(34)"> <text>“Suspension” means a temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specific period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Violation” means an act or omission prohibited under Health Occupations Article, §16-311, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this regulation.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings’ proceedings involving the adjudication of a Board-contested case and the administrative law judge’s recommended decision are confidential. The respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board’s order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel at any stage of a formal disciplinary action.</text> </paragraph> <paragraph num="B."> <text>If a hearing is held on a matter, the respondent shall be represented:</text> <paragraph num="(1)"> <text>In proper person; or</text> </paragraph> <paragraph num="(2)"> <text>By an attorney who has been:</text> <paragraph num="(a)"> <text>Admitted to the Maryland Bar; or</text> </paragraph> <paragraph num="(b)"> <text>Specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may request the Office of the Attorney General to participate in a hearing to present the case on behalf of the State.</text> </paragraph> <paragraph num="D."> <text>The member of the Office of the Attorney General presenting the case on behalf of the State has the same rights as any party with regard to:</text> <paragraph num="(1)"> <text>Submission of evidence, examination, and cross-examination of witnesses; and</text> </paragraph> <paragraph num="(2)"> <text>The filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may request a member of the Office of the Attorney General to act as legal advisor to the Board on questions of:</text> <paragraph num="(1)"> <text>Procedure;</text> </paragraph> <paragraph num="(2)"> <text>Evidence; and</text> </paragraph> <paragraph num="(3)"> <text>Law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings under Health Occupations Article, §16-311, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Make a preliminary review of each complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Recommend that cases involving complaints over which the Board lacks jurisdiction be closed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee that is the subject of the complaint in order to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(3)"> <text>Board subpoenas may be issued by the Board over the signature of the administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>After reviewing any completed investigative information or reports for each complaint, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(c)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(d)"> <text>Refer the matter for further investigation; or</text> </paragraph> <paragraph num="(e)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §19-311, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension if the Board finds that the matter imperatively requires emergency action under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether it has voted to charge a licensee with violations of the Maryland Podiatry Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(a)"> <text>Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Hand-delivered in person; or</text> </paragraph> <paragraph num="(c)"> <text>Served by other means reasonable to effect service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Podiatry Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board’s proceedings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> <paragraph num="(4)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D1(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party, not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness that will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert’s testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §D(2)(a) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments on the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert’s report, that adoption satisfies the requirements set forth in §D(2)(a)(ii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(a)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in Regulation .05E(1) of this chapter, the Board may deny a respondent’s request for a case resolution conference.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="(5)"> <text>Recommendations of the case resolution conference are not binding on the Board, which may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>The Board may require conditions for surrender of a license, including:</text> <paragraph num="(a)"> <text>An admission of a violation of the Maryland Podiatry Act;</text> </paragraph> <paragraph num="(b)"> <text>An admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the Board determines that disclosure of the surrender is not in the public interest, a letter of surrender is a final order of the Board and is a public record under the General Provisions Article, §4-101 et seq., Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings may not be open to the public.</text> </paragraph> <paragraph num="(4)"> <text>All records, including the recommended decision, shall be confidential and sealed.</text> </paragraph> <paragraph num="(5)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>A combination of §B(5)(a) — (c) of this regulation pursuant to the Board’s delegation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>A licensee to whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Podiatry Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge’s proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise permitted by the Board, within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party’s written exceptions may not be longer than 25 double-spaced pages, and shall state with particularity the finding of fact, conclusion of law, or other matter excepted to, and the relevant portions of the record supporting the party’s exception.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise permitted by the Board, within 10 days after a party’s exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party’s answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party’s response to an answer to the exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties’ exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient progress of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The respondent and the administrative prosecutor each may not exceed 30 minutes to present oral argument.</text> </paragraph> <paragraph num="(f)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in an answer to exceptions or in the hearing on exceptions, reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>Upon a finding that there has been a violation of the Maryland Podiatry Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board considers appropriate, including but not limited to:</text> <paragraph num="(1)"> <text>Reeducation or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Providing free podiatry services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Practicing under supervision;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring by the Board or by an individual or entity approved by the Board, with periodic reporting to the Board;</text> </paragraph> <paragraph num="(6)"> <text>Periodic review of a licensee’s clinical practices or billing;</text> </paragraph> <paragraph num="(7)"> <text>Periodic audits of a licensee’s billing practices;</text> </paragraph> <paragraph num="(8)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the licensee’s practice;</text> </paragraph> <paragraph num="(10)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(11)"> <text>Any other condition the Board considers appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when:</text> <paragraph num="(1)"> <text>The specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>The licensee has successfully completed the conditions or acts required for termination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action the final order or consent order provides for a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board’s order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts that constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or failing to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .05E of this chapter.</text> </paragraph> <paragraph num="G."> <text>If the Board determines that a respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action the consent order or final order provides for a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a sanction or take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Post-Disciplinary Reinstatement of a License."> <paragraph num="A."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for a termination of a suspension of a license or a reinstatement after revocation or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee that petitions the Board for reinstatement under the terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board, shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(3)"> <text>A licensee whose license has been revoked or surrendered for 5 or more years before filing a petition for reinstatement is ineligible for reinstatement but may apply for initial licensure.</text> </paragraph> <paragraph num="(4)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Consideration of a Petition for Reinstatement</text> <paragraph num="(1)"> <text>In considering a petition for reinstatement, the Board may review the licensee’s entire Board file, including any information the Board received after the licensee’s suspension, revocation, or surrender.</text> </paragraph> <paragraph num="(2)"> <text>The Board may require the licensee to undergo medical, psychological, psychiatric evaluations, and/or require drug and alcohol testing to determine the licensee’s fitness to have their license reinstated.</text> </paragraph> <paragraph num="(3)"> <text>It is the licensee’s burden, as an applicant for reinstatement, to demonstrate that the licensee meets all of the Board’s requirements for reinstatement of the license at the time of the submission of the petition for reinstatement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, it may impose any restrictions or conditions on the license or the licensee’s practice that it considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §16-315 and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Cost Recovery."> <text>If after a hearing, a licensee is found to have violated any of the provisions of Health Occupations Article, §16-311, Annotated Code of Maryland, the Board shall be entitled to reimbursement of costs by the licensee including any or all of the following items:</text> <paragraph num="A."> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="B."> <text>Transcription of the hearing record by court reporters;</text> </paragraph> <paragraph num="C."> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="D."> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="E."> <text>Hearing-related per diems and expenses for Board members; and</text> </paragraph> <paragraph num="F."> <text>Other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-313 and 16-314; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 19, 1983 (10:25 Md. R. 2269)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 5, 1990 (17:4 Md. R. 497) September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective March 5, 1990 (17:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective March 5, 1990 (17:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B, D amended effective March 5, 1990 (17:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective August 6, 2001 (28:15 Md. R. 1397)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .10 repealed and new Regulations .01 — .10 adopted effective October 26, 2015 (42:21 Md. R. 1302)</annotation> </annotations> </chapter> <chapter num="06" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern advertising by all podiatrists in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following words have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means calling to the attention of the public the services one has to offer.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Podiatrist” means an individual who holds, or is required to hold, a current license to practice podiatry in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>A podiatrist may advertise the services offered by the podiatrist subject to the provisions of this regulation.</text> </paragraph> <paragraph num="B."> <text>Advertisements. Subject to Regulation .04 of this chapter, a podiatrist may:</text> <paragraph num="(1)"> <text>Place advertisements in any form of print or electronic media; or</text> </paragraph> <paragraph num="(2)"> <text>Refer to himself or herself as a:</text> <paragraph num="(a)"> <text>“Podiatrist”;</text> </paragraph> <paragraph num="(b)"> <text>“Foot and ankle specialist”; or</text> </paragraph> <paragraph num="(c)"> <text>“Foot and ankle surgeon”.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An advertisement may not include statements:</text> <paragraph num="(1)"> <text>Containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Likely to mislead or deceive because in context the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to a layman;</text> </paragraph> <paragraph num="(5)"> <text>Conveying the impression that the podiatrist could influence improperly a public body, official, corporation, or a person on behalf of a patient;</text> </paragraph> <paragraph num="(6)"> <text>Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent person to misunderstand or be deceived; or</text> </paragraph> <paragraph num="(7)"> <text>Containing representations that the podiatrist is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A podiatrist shall be accountable under this regulation if the podiatrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <paragraph num="A."> <text>A podiatrist may not engage in solicitation, including but not limited to, in person, telephone, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation or over reaching; or</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .03C of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A podiatrist shall be accountable under this regulation if the podiatrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Advertisement of Free, Discounted, or Reduced Fee Podiatric Goods or Services."> <paragraph num="A."> <text>It is false and misleading advertising for a podiatrist to advertise or otherwise represent that any goods or services (for example, examination or X-rays) shall be offered or performed for:</text> <paragraph num="(1)"> <text>Free when the podiatrist in fact requests or receives a fee for reimbursement, directly or indirectly, for providing those goods or services; or</text> </paragraph> <paragraph num="(2)"> <text>A discounted or reduced fee when the podiatrist in fact requests or receives, directly or indirectly, a higher fee or reimbursement for providing those goods or services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the free, discounted, or reduced price goods or services, a podiatrist, who has not obtained the written informed consent of the patient in the form as shown in §C of this regulation, may not for a fee offer or provide any podiatric goods or services to a patient within 72 hours of the date the patient presents a coupon, voucher, similar document, or advertisement offering:</text> <paragraph num="(1)"> <text>“Free” podiatric goods or services; or</text> </paragraph> <paragraph num="(2)"> <text>Podiatric goods or services for a discounted or reduced fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The podiatrist shall use the following Consent to Treatment Form and shall retain the form in the patient's file:</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalties for Violation."> <text>The Board may enforce this chapter against the podiatrist by any appropriate ground for disciplinary action, under Health Occupations Article, §16-311, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-205(a)(1) and 16-311(a)(20), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 4, 1988 (15:7 Md. R. 849)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 5, 1990 (17:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective July 2, 2018 (45:13 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective March 5, 1990 (17:4 Md. R. 497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 recodified to .06 and new Regulation .05 adopted effective October 12, 1992 (19:20 Md. R. 1815)</annotation> </annotations> </chapter> <chapter num="07" heading="Civil Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the standards by which the Board may impose an administrative monetary penalty not exceeding $50,000 on any individual licensed under Health Occupations Article, Title 16, Annotated Code of Maryland, for an act or omission proscribed under Health Occupations Article, §16-311(a), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means an individual licensed by the Board to practice podiatry including the holder of a limited license.</text> </paragraph> <paragraph num="(3)"> <text>“Violation” means an act or omission proscribed under Health Occupations Article, §§16-311(a) and 16-501, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authority to Impose Civil Monetary Penalty."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §16-313, Annotated Code of Maryland, and COMAR 10.40.05, the Board may impose a civil monetary penalty of no less than $1,000 and no more than $50,000 under this chapter against an individual who commits a violation.</text> </paragraph> <paragraph num="B."> <text>A penalty under §A of this regulation may be imposed:</text> <paragraph num="(1)"> <text>In addition to any reprimand, probation, suspension, or revocation; and</text> </paragraph> <paragraph num="(2)"> <text>For each occasion the licensee commits a violation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may impose a civil monetary penalty against an individual who practices podiatry without a license in violation of Health Occupations Article, §16–501, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Board may not impose a fine under §C of this regulation against a podiatrist for practicing podiatry on an expired license if the:</text> <paragraph num="(1)"> <text>Podiatrist’s license is reinstated within 30 calendar days of the expiration date of the license; and</text> </paragraph> <paragraph num="(2)"> <text>The licensee complies with COMAR 10.40.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Factors to be Considered in the Assessment of Penalties."> <text>The Board shall consider the following factors in determining whether to impose a penalty and the amount of any penalty:</text> <paragraph num="A."> <text>The extent to which the individual derived any financial benefit from the violation;</text> </paragraph> <paragraph num="B."> <text>The willfulness of the improper conduct;</text> </paragraph> <paragraph num="C."> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="D."> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="E."> <text>The individual’s history of any previous violation; and</text> </paragraph> <paragraph num="F."> <text>If the penalty being imposed is for unauthorized practice, the length of time in which the individual engaged in the unauthorized practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Payment of Penalties."> <paragraph num="A."> <text>The individual shall pay to the Board, on the date of its order, any administrative monetary penalty imposed under this chapter.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal does not stay payment of any penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If an individual fails to pay, in whole or in part, any penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew the license of the individual until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Fiscal Planning to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay into the General Fund of the State all monies collected under this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-205, 16-311, and 16-505(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 25, 1988 (15:15 Md. R. 1810)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 22, 2003 (30:25 Md. R. 1848); March 2, 2015 (42:4 Md. R. 434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 2, 2015 (42:4 Md. R. 434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F adopted effective March 2, 2015 (42:4 Md. R. 434)</annotation> </annotations> </chapter> <chapter num="08" heading="Interpretation of Terms in the Maryland Podiatry Act"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations define and interpret certain terms used in the Maryland Podiatry Act, Health Occupations Article, Title 16, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In the Maryland Podiatry Act, the following words have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abandons a patient” includes but is not limited to the failure to treat a patient with whom the podiatrist has had a continual patient-podiatrist relationship, for any reason, including nonpayment of a bill, without giving the patient reasonable notice that the relationship is terminated.</text> </paragraph> <paragraph num="(2)"> <text>“Foot appliance” means orthotics or prosthetics.</text> </paragraph> <paragraph num="(3)"> <text>“Postgraduate clinical training” means training beyond the Doctor of Podiatric Medicine degree in a program that is accredited by the Council on Podiatric Medical Education of the American Podiatric Medical Association and approved by the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Practiced actively” means for the immediately preceding 5 years has been actively engaged in the practice of podiatric medicine for at least 400 hours on average per year.</text> </paragraph> <paragraph num="(5)"> <text>“Unprofessional conduct” includes but is not limited to:</text> <paragraph num="(a)"> <text>Willful or grossly negligent failure to comply with substantial provisions of federal or State laws, rules, or regulations governing the practice of podiatric medicine;</text> </paragraph> <paragraph num="(b)"> <text>Exercising undue influence on a patient including the promotion or the sale of services, goods, appliances, or drugs in such manner as to exploit the patient for the financial gain of the practitioner or a third party;</text> </paragraph> <paragraph num="(c)"> <text>Conduct in the practice of podiatric medicine which evidences moral unfitness to practice the profession;</text> </paragraph> <paragraph num="(d)"> <text>Practicing or offering to practice beyond the scope permitted by law, or accepting and performing professional responsibilities which the podiatrist knows or has reason to know the podiatrist is not competent to perform;</text> </paragraph> <paragraph num="(e)"> <text>Delegating podiatric medical responsibilities to a person when the podiatrist delegating these responsibilities knows or has reason to know that the person is not qualified by training, experience, or licensure to perform them;</text> </paragraph> <paragraph num="(f)"> <text>Performing podiatric medical services which have not been duly authorized by the patient or the patient's legal representative;</text> </paragraph> <paragraph num="(g)"> <text>Ordering of excessive tests, treatment, or use of treatment facilities not warranted by the condition of the patient;</text> </paragraph> <paragraph num="(h)"> <text>Claiming or using any secret or special method of treatment which the podiatrist refuses to divulge to the Board upon request; or</text> </paragraph> <paragraph num="(i)"> <text>Fragmentation of a general procedure to increase the reimbursement.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examples of Fragmentation of Billing."> <paragraph num="A."> <text>By way of illustration, but not limitation, fragmentation of billing in Regulation .02B(3)(i), of this chapter, includes breaking the following general procedures into the following listed specific procedures:</text> <paragraph num="(1)"> <text>Keller bunionectomy — a multi-step procedure, which may include any or all of the following:</text> <paragraph num="(a)"> <text>Resection of medial eminence 1st metatarsal head;</text> </paragraph> <paragraph num="(b)"> <text>Resection base of proximal phalanx;</text> </paragraph> <paragraph num="(c)"> <text>Capsulotomy/capsulorrhaphy;</text> </paragraph> <paragraph num="(d)"> <text>Z-plasty of extensor tendon; and</text> </paragraph> <paragraph num="(e)"> <text>Sesamoidectomy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Lesser metatarsal osteotomy — a multi-step procedure, which may include any or all of the following:</text> <paragraph num="(a)"> <text>Tenoplasty;</text> </paragraph> <paragraph num="(b)"> <text>Capsulotomy/capsulorrhaphy;</text> </paragraph> <paragraph num="(c)"> <text>Osteotomy; and</text> </paragraph> <paragraph num="(d)"> <text>Fixation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Fragmentation of billing is especially egregious when the licensee bills for both the general and specific procedures.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §16-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 26, 1990 (17:23 Md. R. 2732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 2, 2009 (36:22 Md. R. 1724); July 2, 2018 (45:13 Md. R. 668)</annotation> </annotations> </chapter> <chapter num="09" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter permits the Board to disclose investigative information to other agencies, or other entities, or both, under certain circumstances.</text> </paragraph> <paragraph num="B."> <text>A custodian may disclose information in a licensing or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>The custodian may find that a compelling public purpose warrants disclosure of information in a licensing or investigative file, regardless of whether there has been a request for the information, and may disclose the information under the following circumstances:</text> <paragraph num="A."> <text>The information concerns possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>The information concerns a possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>The information concerns conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333; Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §16-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 15, 2002 (29:7 Md. R. 621)</annotation> </annotations> </chapter> <chapter num="10" heading="General Provisions"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>Unless licensed by the Board, an individual may not examine, diagnose, or surgically, medically, or mechanically treat:</text> <paragraph num="(1)"> <text>The human foot or ankle;</text> </paragraph> <paragraph num="(2)"> <text>The anatomical structures that attach to the human foot; or</text> </paragraph> <paragraph num="(3)"> <text>The soft tissue below the mid-calf.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Only a licensed podiatrist may examine, diagnose, and determine the medical necessity to prescribe a foot appliance.</text> </paragraph> <paragraph num="C."> <text>This subtitle does not:</text> <paragraph num="(1)"> <text>Limit the right of an individual to practice a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Affect the commercial sale or fitting of shoes or foot appliances.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§16-101(f), 16-102, and 16-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 2, 2009 (36:22 Md. R. 1724)</annotation> </annotations> </chapter> <chapter num="11" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for use as a guide for the imposition of disciplinary sanctions against any Maryland licensed podiatrist, if after a hearing the Board finds that there are grounds under Health Occupations Article, §16-311, Annotated Code of Maryland, to place a licensee on probation, reprimand, suspend, fine, or revoke a license. The Board may consider aggravating and mitigating factors in determining sanctions.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Podiatric Medical Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means an individual who holds a license or a limited license to practice podiatry in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Application."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees.</text> </paragraph> <paragraph num="B."> <text>The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines.</text> </paragraph> <paragraph num="C."> <text>A departure from the sanctioning guidelines alone is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>Notwithstanding this chapter, in order to resolve a disciplinary matter, the Board and the licensee may agree to a surrender of license or a consent order with terms, conditions, and sanctions agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="E."> <text>In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated in Regulation .04 of this chapter for each individual violation.</text> </paragraph> <paragraph num="F."> <text>If probation is imposed, the Board may impose appropriate terms and conditions of probation, and if a licensee violates the terms or conditions of probation, the Board may take further disciplinary action against the licensee.</text> </paragraph> <paragraph num="G."> <text>In the event the licensee’s violation does not fall within the sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and shall consider, to the extent possible, the factors in Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Range of Sanctions."> <text>Tier Conduct Sanction Range Minimum Maximum A. Sexual misconduct (1) Sexual misconduct with a patient Suspension with conditions Revocation (2) Lewd and immoral conduct within practice Suspension with conditions Revocation B. Minimal standards of care (1) Departure from or failure to conform to appropriate standards of care Reprimand with conditions, subsequent probation as appropriate Revocation (2) Failure to keep adequate medical records Reprimand with conditions, subsequent probation as appropriate Revocation (3) Failure to educate a patient about appropriate alternative methods of treatment in violation of law or the standard of care. Reprimand with conditions, subsequent probation as appropriate Revocation (4) Failure to obtain informed consent Reprimand with conditions, subsequent probation as appropriate Revocation (5) Incompetence Reprimand with conditions Revocation C. Knowingly submitting to a third party any claim form, bill, or statement which contains any misleading, deceptive, false, incomplete, or fraudulent representation asserting a fee which is greater than the fee usually accepted as payment in full for any given procedure or service (1) Overutilization of billing and/or false claims reporting Reprimand with conditions, subsequent probation as appropriate Revocation (2) Billing fraudulently Reprimand with conditions, subsequent probation as appropriate Revocation (3) Health care fraud Reprimand with conditions, subsequent probation as appropriate Revocation D. DEA or controlled dangerous substance violation, or improper prescribing, dispensing or administering of drugs (1) Prescribing, dispensing, or administering of controlled substances for excessive periods of time and/or excessive amounts Probation 6 months with conditions Revocation (2) Improper prescribing, dispensing, or administering of any drug Reprimand with conditions Revocation (3) Prescribing, dispensing, or administering of controlled substances without appropriate examination Reprimand with conditions, subsequent probation as appropriate Revocation (4) Failure to keep adequate patient records of substances prescribed, dispensed, or administered Reprimand with conditions, subsequent probation as appropriate Revocation (5) Failure to use acceptable methods in selection of drugs or other modalities Reprimand with conditions, subsequent probation as appropriate Revocation (6) Selling, prescribing, giving away, or administering of any drugs for illegal or illegitimate medical purposes Suspension 6 months with conditions, subsequent probation as appropriate Revocation (7) Prescribing, dispensing, or administering of any drugs without medical indication to detriment of the patient Reprimand with conditions, subsequent probation as appropriate Revocation (8) Prescribing, dispensing, or administering of drugs for sexual favors Suspension 1 year with conditions, subsequent probation as appropriate Revocation (9) Taking back any drug from a patient that was prescribed Reprimand with conditions, subsequent probation as appropriate Revocation E. Unprofessional or unethical conduct (1) Willfully betraying a professional confidence Reprimand with conditions, subsequent probation as appropriate Revocation (2) Abandoning a patient Reprimand with conditions, subsequent probation as appropriate Revocation (3) Failure to provide a patient’s medical record as required by law Reprimand with conditions, subsequent probation as appropriate Revocation (4) Failure to cooperate with a Board investigation Reprimand with conditions, subsequent probation as appropriate Revocation (5) By corrupt means, threats, or force, intimidating, influencing, or attempting to influence a person to change or withhold testimony in hearings or before the Board or the Office of Administrative Hearings Suspension with conditions, subsequent probation as appropriate Revocation (6) By corrupt means, threats, or force, hindering, preventing, or otherwise delaying a person from making information available to the Board in the furtherance of a Board investigation. Suspension with conditions, subsequent probation as appropriate Revocation F. Substance abuse (using any narcotic or controlled dangerous substance or other drug that is in excess of therapeutic amounts or without valid medical indication) (1) Self-referral Reprimand with conditions Revocation (2) Complaint initiated Reprimand with conditions, subsequent probation as appropriate Revocation (3) Impaired ability to practice by reason of substance abuse Reprimand with conditions Revocation G. Other Acts (1) Practicing outside scope Reprimand with conditions, subsequent probation as appropriate Revocation (2) Practicing while Maryland podiatry license is suspended or revoked Suspension Revocation (3) Committing or having committed a felony Suspension with conditions Revocation (4) Willfully making a false report or record in the practice of podiatry Reprimand with conditions Revocation (5) Knowingly filing a falsified license renewal or falsifying a license renewal Reprimand with conditions Revocation (6) Practicing with a condition, illness, or disease that may impair the ability of the individual to perform podiatric services Reprimand with conditions Revocation (7) Credentialing fraud Probation with conditions Revocation (8) Other violations of the Act Reprimand Revocation</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors."> <text>Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside of the range of sanctions established by the guidelines. These factors may include, but are not limited, to the following:</text> <paragraph num="A."> <text>Mitigating factors:</text> <paragraph num="(1)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The licensee having reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The licensee having voluntarily admitted violation, provided full disclosure to the Board, and cooperated during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>The licensee having implemented remedial measures to correct or mitigate harm arising from the violation;</text> </paragraph> <paragraph num="(5)"> <text>The licensee having made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or potential for rehabilitation;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the violation;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm to or adverse impact on the public;</text> </paragraph> <paragraph num="(9)"> <text>Isolated incident and not likely to recur; and</text> </paragraph> <paragraph num="(10)"> <text>The licensee’s prior community service and present value to the community; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating factors:</text> <paragraph num="(1)"> <text>Previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee was motivated to perform the violation by his or her financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the patient;</text> </paragraph> <paragraph num="(7)"> <text>The licensee attempted to conceal the violation, falsified or destroyed evidence, or presented false testimony or evidence;</text> </paragraph> <paragraph num="(8)"> <text>The licensee failed to cooperate with the Board’s investigation; and</text> </paragraph> <paragraph num="(9)"> <text>Previous attempts at rehabilitation were unsuccessful.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 16-205, and 16-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 16, 2012 (39:7 Md. R. 494)</annotation> </annotations> </chapter> <chapter num="12" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of podiatry using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(3)"> <text>“Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology.</text> </paragraph> <paragraph num="(4)"> <text>“Remote patient monitoring” means the use of telehealth devices to collect medical and other forms of health data from patients that are securely provided to a telehealth practitioner in a different location for assessment, recommendation, and diagnosis.</text> </paragraph> <paragraph num="(5)"> <text>“Store and forward technology” means the asynchronous transmission of digital images, documents, and videos electronically through secure means.</text> </paragraph> <paragraph num="(6)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(7)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, of the Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Telehealth devices” means devices that gather visual or other data and remotely send the images or data to a telehealth practitioner in a different location from the patient.</text> </paragraph> <paragraph num="(9)"> <text>“Telehealth practitioner” means a Maryland-licensed podiatrist performing telehealth services within the scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, Title 16, Subtitle 3, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before providing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Contact information; and</text> </paragraph> <paragraph num="(c)"> <text>Maryland license number;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except for interpretive services, obtain oral or written acknowledgement from a patient or a patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of prescribed treatments;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the patient’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when utilizing store and forward technology to provide telehealth services or remote patient monitoring, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person health care settings.</text> </paragraph> <paragraph num="D."> <text>A telehealth practitioner may not prescribe opioids for the treatment of pain through telehealth except if the patient is in a health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>Except when providing asynchronous telehealth services or remote patient monitoring, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Perform a clinical patient evaluation adequate to establish a diagnosis and identify underlying conditions or contraindications to recommended treatment options before providing treatment or prescribing medication through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person health care services; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the evaluation is adequate to comply with §A of this regulation, a telehealth practitioner may use:</text> <paragraph num="(1)"> <text>Telehealth devices;</text> </paragraph> <paragraph num="(2)"> <text>Live synchronous audio-visual communication;</text> </paragraph> <paragraph num="(3)"> <text>Other methods of performing a medical examination remotely; or</text> </paragraph> <paragraph num="(4)"> <text>A patient evaluation performed by another licensed health care practitioner providing coverage.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner may not treat a patient or issue a prescription based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with Regulations .04 and .05 of this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 795)</annotation> </annotations> </chapter> </subtitle> <subtitle num="41" heading="Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists"> <chapter num="01" heading="Collection of Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all persons licensed as audiologists, audiology assistants, hearing aid dispensers, speech-language pathologists, speech-language pathology assistants, or music therapists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>Application fee for full audiology, speech-language pathology license ... $150</text> </paragraph> <paragraph num="B."> <text>Hearing aid dispenser examination fee ... $150</text> </paragraph> <paragraph num="C."> <text>Repeat hearing aid dispenser written examination ... $100</text> </paragraph> <paragraph num="D."> <text>Waiver of hearing aid dispenser written examination ... $100</text> </paragraph> <paragraph num="E."> <text>Biennial renewal of license fee ... $250</text> </paragraph> <paragraph num="F."> <text>Biennial renewal of dual audiology/speech-language pathology license fee ... $400</text> </paragraph> <paragraph num="G."> <text>Late fee for renewal of license ... $100</text> </paragraph> <paragraph num="H."> <text>Application fee for Audiology and Speech-Language Pathology Interstate Compact (ASLP-IC) privileges ... $100</text> </paragraph> <paragraph num="I."> <text>Reinstatement of expired license:</text> <paragraph num="(1)"> <text>Fee to reinstate an expired license where the licensee did not actively practice in another state ... $200;</text> </paragraph> <paragraph num="(2)"> <text>Fee to reinstate an expired license where the licensee was actively licensed and practicing in another state ... $50</text> </paragraph> </paragraph> <paragraph num="J."> <text>Application fee for limited audiology or speech-language pathology license ... $100</text> </paragraph> <paragraph num="K."> <text>Application fee for hearing aid dispenser limited license and examination ... $150</text> </paragraph> <paragraph num="L."> <text>Renewal of limited license fee ... $25</text> </paragraph> <paragraph num="M."> <text>Physical copy of registration certificate ... $5</text> </paragraph> <paragraph num="N."> <text>Physical copy of wall certificate ... $25</text> </paragraph> <paragraph num="O."> <text>Application fee for full speech-language pathology assistant or audiology assistant license ... $100</text> </paragraph> <paragraph num="P."> <text>Application fee for limited speech-language pathology assistant license ... $100</text> </paragraph> <paragraph num="Q."> <text>Biennial renewal of full speech-language pathology assistant or audiology assistant license fee ... $100</text> </paragraph> <paragraph num="R."> <text>Renewal of limited speech-language pathology assistant license fee ... $25</text> </paragraph> <paragraph num="S."> <text>Verification of license fee ... $25</text> </paragraph> <paragraph num="T."> <text>Returned check fee ... $25</text> </paragraph> <paragraph num="U."> <text>Speech-language pathologists roster fee ... $75</text> </paragraph> <paragraph num="V."> <text>Audiologists roster fee ... $55</text> </paragraph> <paragraph num="W."> <text>Hearing aid dispensers roster fee ... $55</text> </paragraph> <paragraph num="X."> <text>Music therapists roster fee ... $55</text> </paragraph> <paragraph num="Y."> <text>Inactive status fee ... $25</text> </paragraph> <paragraph num="Z."> <text>Reactivation fee ... $50 in addition to renewal fee and Maryland Health Care Commission fee</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Changes in Fees."> <paragraph num="A."> <text>Fees are subject to change by action of the Board. All licensees and applicants will be notified of changes.</text> </paragraph> <paragraph num="B."> <text>Application forms should be requested from the Board of Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Fee Exceptions."> <text>An audiologist, hearing aid dispenser, speech-language pathologist, or music therapist who holds a current license is exempt from paying the license verification fee.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Refunds, Proration, Prohibition."> <text>Fees paid to the Board are nonrefundable and may not be prorated.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205 and 2-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 25, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .02, .03B amended effective March 31, 1976 (3:7 Md. R. 401); October 12, 1992 (19:20 Md. R. 1815)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 repealed and new Regulations .01 and .02 adopted effective December 20, 1993 (20:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 3, 2003 (30:2 Md. R. 76); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 14, 1978 (5:14 Md. R. 1137); November 7, 1983 (10:22 Md. R. 1966); March 25, 1996 (23:6 Md. R. 476); February 3, 2003 (30:2 Md. R. 76); February 16, 2004 (31:3 Md. R. 208); January 28, 2008 (35:2 Md. R. 127); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L—O adopted as an emergency provision effective March 1, 2002 (29:7 Md. R. 617); adopted permanently effective June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G—H amended March 17, 2014 (41:5 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02W—X adopted March 17, 2014 (41:5 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 14, 1978 (5:14 Md. R. 1137); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 7, 1983 (10:22 Md. R. 1966)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective February 3, 2003 (30:2 Md. R. 76)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 recodified to be Regulation .05 and new Regulation .04 adopted effective January 28, 2008 (35:2 Md. R. 127)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> <chapter num="02" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs individuals licensed as audiologists, audiology assistants, hearing aid dispensers, speech-language pathologists, speech-language pathology assistants, or music therapists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Responsibilities."> <paragraph num="A."> <text>The licensee shall consider paramount the welfare of individuals served professionally.</text> </paragraph> <paragraph num="B."> <text>Necessary Training. The licensee shall:</text> <paragraph num="(1)"> <text>Obtain proper training for the services the licensee provides; and</text> </paragraph> <paragraph num="(2)"> <text>Be prepared to document, at the request of the Board, any training obtained.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Professional Conduct.</text> <paragraph num="(1)"> <text>The licensee may not be represented by titles which are not consistent with training.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall follow acceptable patterns of professional conduct in relationship with the individuals served and engage in only the aspects of the profession that are within the scope of the licensee's competence.</text> </paragraph> <paragraph num="(3)"> <text>The licensee may not guarantee the result of a speech-language or hearing consultation or therapeutic procedure. A guarantee of any sort expressed or implied, oral or written, is contrary to professional ethics. The licensee may make a reasonable statement of the anticipated results, but, because successful results are dependent on many factors, a warranty is deceptive and unethical.</text> </paragraph> <paragraph num="(4)"> <text>The licensee may not diagnose or treat individual speech or hearing disorders by correspondence. This does not preclude follow-up by correspondence with individuals previously seen. It also does not preclude providing the persons served professionally with general information of an educational nature.</text> </paragraph> <paragraph num="(5)"> <text>The licensee may not reveal to unauthorized persons professional or personal information about the individual professionally served without appropriate permission from that individual, unless required by law.</text> </paragraph> <paragraph num="(6)"> <text>The licensee may not exploit individuals served professionally by:</text> <paragraph num="(a)"> <text>Accepting them for treatment when benefit cannot reasonably be expected to accrue;</text> </paragraph> <paragraph num="(b)"> <text>Continuing treatment unnecessarily;</text> </paragraph> <paragraph num="(c)"> <text>Charging for services not rendered;</text> </paragraph> <paragraph num="(d)"> <text>Failing to fully inform the individual served of the nature and possible effects of services rendered, or products dispensed, or both;</text> </paragraph> <paragraph num="(e)"> <text>Misrepresenting services rendered, or products dispensed, or both; or</text> </paragraph> <paragraph num="(f)"> <text>Failing to obtain informed consent to use the individual served for research or as subjects of teaching demonstrations.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Licensees may not refuse to treat based upon:</text> <paragraph num="(a)"> <text>Race;</text> </paragraph> <paragraph num="(b)"> <text>Religion;</text> </paragraph> <paragraph num="(c)"> <text>Color;</text> </paragraph> <paragraph num="(d)"> <text>Age;</text> </paragraph> <paragraph num="(e)"> <text>National origin;</text> </paragraph> <paragraph num="(f)"> <text>Marital status;</text> </paragraph> <paragraph num="(g)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(h)"> <text>Gender identity; or</text> </paragraph> <paragraph num="(i)"> <text>Disability.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The licensee shall use every resource available, including referral to other specialists as needed, to effect maximal improvements in the individuals served.</text> </paragraph> <paragraph num="E."> <text>The licensee shall take every precaution to avoid harm to the individual served professionally.</text> </paragraph> <paragraph num="F."> <text>Sexual Misconduct.</text> <paragraph num="(1)"> <text>An audiologist, audiology assistant, hearing aid dispenser, speech-language pathologist, speech-language pathology assistant, or music therapist may not engage in sexual misconduct in the practice of audiology, hearing aid dispensing, speech-language pathology, or music therapy.</text> </paragraph> <paragraph num="(2)"> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(a)"> <text>Sexual behavior with an individual served in the context of a professional evaluation, treatment, procedure, or other service to the client or patient, regardless of the setting in which the professional service is provided;</text> </paragraph> <paragraph num="(b)"> <text>Sexual behavior with an individual served under the pretense of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(c)"> <text>A sexual relationship, whether consensual or non-consensual, with an individual served;</text> </paragraph> <paragraph num="(d)"> <text>Making sexual advances toward an individual served or requesting sexual favors;</text> </paragraph> <paragraph num="(e)"> <text>Therapeutically inappropriate or intentional touching in a sexual manner of an individual served;</text> </paragraph> <paragraph num="(f)"> <text>Physical contact of a sexual nature with an individual served;</text> </paragraph> <paragraph num="(g)"> <text>Therapeutically unnecessary discussion of sexual matters or other verbal conduct of a sexual nature while treating the individual being served;</text> </paragraph> <paragraph num="(h)"> <text>Directly or indirectly watching the individual served while the individual is undressing or dressing when it is not part of the therapeutic process;</text> </paragraph> <paragraph num="(i)"> <text>Taking, for sexual purposes, photographs or video- tapes of an individual served;</text> </paragraph> <paragraph num="(j)"> <text>Sexual harassment of staff or students; or</text> </paragraph> <paragraph num="(k)"> <text>Sexual contact with an incompetent or unconscious individual being served.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Penalties. Violation of Regulation .02 may result in Board action to reprimand the licensee, place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $5,000.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>The licensee may not include statements in advertising that:</text> <paragraph num="(1)"> <text>Misrepresent facts;</text> </paragraph> <paragraph num="(2)"> <text>Are likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Are intended to or are likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relate to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to laypersons;</text> </paragraph> <paragraph num="(5)"> <text>Convey the impression that the licensee could influence improperly any public body, official, corporation, or any person on behalf of the individual served professionally;</text> </paragraph> <paragraph num="(6)"> <text>Contain representations or implications that in reasonable probability can be expected to cause an ordinarily prudent person to misunderstand or be deceived;</text> </paragraph> <paragraph num="(7)"> <text>Contain representations that the licensee is willing to perform a procedure which is illegal in Maryland or the United States; or</text> </paragraph> <paragraph num="(8)"> <text>Falsely disparage competitors, the competitors' products, or the competitors' methods of doing business.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee may not use an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> <paragraph num="C."> <text>Solicitation. A licensee may not engage in solicitation including but not limited to in-person, telephone, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation, or overreaching; or</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which are prohibited under §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Special Responsibilities."> <paragraph num="A."> <text>The licensee shall seek open professional discussion of all theoretical and practical issues, but avoid personal invective directed toward professional colleagues or members of allied professions.</text> </paragraph> <paragraph num="B."> <text>The licensee shall guard against conflicts of professional interest.</text> </paragraph> <paragraph num="C."> <text>The licensee may not enter into a commercial agreement that financially exploits an individual served professionally.</text> </paragraph> <paragraph num="D."> <text>The licensee may not engage in commercial activities that conflict with the licensee's responsibilities to individuals served professionally.</text> </paragraph> <paragraph num="E."> <text>In the licensee’s professional relationships with colleagues or individuals served professionally, the licensee may not discriminate on the basis of:</text> <paragraph num="(1)"> <text>Race;</text> </paragraph> <paragraph num="(2)"> <text>Religion;</text> </paragraph> <paragraph num="(3)"> <text>Color;</text> </paragraph> <paragraph num="(4)"> <text>Age;</text> </paragraph> <paragraph num="(5)"> <text>National origin;</text> </paragraph> <paragraph num="(6)"> <text>Marital status;</text> </paragraph> <paragraph num="(7)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(8)"> <text>Gender identity; or</text> </paragraph> <paragraph num="(9)"> <text>Disability.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The licensee may not provide professional services without exercising independent professional judgment, regardless of referral source or prescription.</text> </paragraph> <paragraph num="G."> <text>The licensee may delegate duties to support personnel under the supervision of the licensee if the delegated duties do not require the professional skill and judgment specific to the licensee's scope of practice.</text> </paragraph> <paragraph num="H."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Maintain adequate records of professional services rendered and products dispensed, including:</text> <paragraph num="(a)"> <text>A full written report outlining all diagnostic results and any recommendations;</text> </paragraph> <paragraph num="(b)"> <text>Daily therapy notes such as subjective, objective, assessment, and plan (SOAP) log notes;</text> </paragraph> <paragraph num="(c)"> <text>License number on written client reports and evaluations;</text> </paragraph> <paragraph num="(d)"> <text>Progress reports; and</text> </paragraph> <paragraph num="(e)"> <text>All documents related to referrals; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Allow access to these records when appropriately authorized.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The licensee shall withdraw from professional practice when substance abuse or emotional, mental, or physical disability may adversely affect the quality of services rendered.</text> </paragraph> <paragraph num="J."> <text>The licensee who has reason to believe that another licensee has violated the Code of Ethics shall inform the Board.</text> </paragraph> <paragraph num="K."> <text>The licensee shall cooperate fully with the Board in an investigation and adjudication of matters related to the Code of Ethics.</text> </paragraph> <paragraph num="L."> <text>The licensee may not construe the failure to specify a particular responsibility or practice in this chapter as indicating that the responsibility or practice is not equally as important as those specified. An act that is in violation of the spirit and purpose of the Code of Ethics constitutes unprofessional conduct and may result in disciplinary action against the licensee under Health Occupations Article, §2-314, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 2-205 and 2-314, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 25, 1974</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 23, 1998 (25:6 Md. R. 488); January 6, 2003 (29:26 Md. R. 2027); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 22, 1980 (7:4 Md. R. 348); March 23, 1998 (25:6 Md. R. 488); January 6, 2003 (29:26 Md. R. 2027); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F and G amended effective June 26, 2000 (27:12 Md. R. 1140)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed effective February 22, 1980 (7:4 Md. R. 348)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective March 23, 1998 (25:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 22, 1980 (7:4 Md. R. 348); March 23, 1998 (25:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E, H amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> <chapter num="03" heading="Licensure and Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern an individual practicing as a speech-language pathologist or audiologist, or both, in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means:</text> <paragraph num="(a)"> <text>A college or university located in the U.S. whose program has been accredited by a national accrediting association recognized by the:</text> <paragraph num="(i)"> <text>Council for Higher Education Accreditation; or</text> </paragraph> <paragraph num="(ii)"> <text>United States Department of Education; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A college or university located outside the U.S. whose program has met the standards for certification of the governing educational body that is regulated by the government of the country where the college or university is located.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“Credit” means 1 semester hour except when specified in these regulations. “Credit” is used only with reference to fulfilling academic requirements for original licensure application.</text> </paragraph> <paragraph num="(4)"> <text>“Continuing education unit (CEU)” means a period of 60 minutes for a licensee's direct participation in an approved continuing education experience. “Continuing education unit (CEU)” is used only with reference to fulfilling requirements for renewal of full licensure.</text> </paragraph> <paragraph num="(5)"> <text>“Examination” means the National Examination in Speech-Language Pathology or the National Examination in Audiology.</text> </paragraph> <paragraph num="(6)"> <text>“Oral competency” means the demonstration of general English-speaking proficiency by receiving a passing score on a standardized test that the Board has approved.</text> </paragraph> <paragraph num="(7)"> <text>“Pro bono work” means work provided within the State within the scope of practice of the licensee that is performed without financial reimbursement or direct financial gain.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Requirements."> <paragraph num="A."> <text>Limited Licensure.</text> <paragraph num="(1)"> <text>A person who has met all requirements for licensure except supervised post-graduate professional experience or examination, or both, may apply for limited licensure.</text> </paragraph> <paragraph num="(2)"> <text>An individual seeking limited licensure shall fulfill the following requirements:</text> <paragraph num="(a)"> <text>Hold a master's degree in speech-language pathology or a doctoral degree in audiology, or both, from an accredited educational institution having a graduate or doctoral program in either field;</text> </paragraph> <paragraph num="(b)"> <text>Have met the academic and practicum requirements for a Certificate of Clinical Competence of the American Speech-Language-Hearing Association or Board Certification in Audiology from the American Board of Audiology that were in effect at the time a master's degree in speech pathology or doctoral degree in either field was obtained; and</text> </paragraph> <paragraph num="(c)"> <text>Demonstrate oral English competency as follows:</text> <paragraph num="(i)"> <text>Completion of at least 60 credits from an undergraduate college or university where English was the language of instruction throughout the applicant's inclusive dates of attendance; or</text> </paragraph> <paragraph num="(ii)"> <text>Achievement of a minimum score of 105, with at least a 26 on Speaking and Listening, on the Test of English as a Foreign Language (TOEFL) within the 2 years preceding license application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Application.</text> <paragraph num="(a)"> <text>An individual applying for limited licensure shall submit a complete application.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall determine whether an application is complete.</text> </paragraph> <paragraph num="(c)"> <text>A complete application shall include:</text> <paragraph num="(i)"> <text>The application fee;</text> </paragraph> <paragraph num="(ii)"> <text>All required documentation regarding supervision of the limited licensee; and</text> </paragraph> <paragraph num="(iii)"> <text>An official transcript from the accredited educational institution attended by the applicant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon approval of an application, the Board shall issue a document authorizing the applicant to practice in this State in accordance with Health Occupations Article, §2-306, Annotated Code of Maryland, and the regulations in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision of Professional Experience for Audiologists.</text> <paragraph num="(1)"> <text>Supervisory Plan for Audiologists.</text> <paragraph num="(a)"> <text>Each applicant shall submit to the Board for approval a description of the supervisory plan to be followed during the period of limited licensure.</text> </paragraph> <paragraph num="(b)"> <text>The plan shall show adequate supervision, in accordance with this chapter.</text> </paragraph> <paragraph num="(c)"> <text>The Board may accept completion of the clinical fellowship required for the American Speech-Language-Hearing Association Certificate of Clinical Competence or completion of the mentored practice required for American Board of Audiology Certification as meeting the requirements for supervised practice in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless an exception is approved by the Board for extenuating circumstances, an applicant shall begin the clinical training within 2 years after completion of the academic course work and academic clinical practicum requirements and shall complete the clinical training within 24 months.</text> </paragraph> <paragraph num="(3)"> <text>To complete a clinical training, the applicant shall be employed as a professional in the field of audiology under appropriate on-site direct supervision for not less than 9 months with a minimum of 36 hours of work per week. This requirement may also be met with part-time employment as follows:</text> <paragraph num="(a)"> <text>14—16 hours a week for a period of 24 months;</text> </paragraph> <paragraph num="(b)"> <text>17—20 hours a week for a period of 18 months;</text> </paragraph> <paragraph num="(c)"> <text>21—24 hours a week for a period of 15 months;</text> </paragraph> <paragraph num="(d)"> <text>25—35 hours a week for a period of 12 months.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At least 80 percent of the applicant's employment during the clinical training shall be in direct client contact which includes:</text> <paragraph num="(a)"> <text>Assessment/diagnosis/evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Screening, response to intervention (RTI), or observations of clients;</text> </paragraph> <paragraph num="(c)"> <text>Treatment, such as:</text> <paragraph num="(i)"> <text>Hearing device fitting;</text> </paragraph> <paragraph num="(ii)"> <text>Diagnostic assessment; and</text> </paragraph> <paragraph num="(iii)"> <text>Rehabilitation; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Activities related to client management including:</text> <paragraph num="(i)"> <text>Writing reports and notes;</text> </paragraph> <paragraph num="(ii)"> <text>Billing;</text> </paragraph> <paragraph num="(iii)"> <text>Making rounds; and</text> </paragraph> <paragraph num="(iv)"> <text>Attendance at an individualized education program (IEP), individualized family service plan (IFSP) meeting, or other meetings related to the management of a client’s diagnosis and treatment plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>An individual serving as a supervisor:</text> <paragraph num="(a)"> <text>Shall hold a valid license issued by the Board in audiology, or if the supervisor is employed by a facility whose employees qualify for an exemption from licensure the Certificate of Clinical Competence of the American Speech-Language-Hearing Association in audiology or Board Certification in Audiology from the American Board of Audiology;</text> </paragraph> <paragraph num="(b)"> <text>Shall have been in practice for a minimum of 3 years after completion of the clinical training;</text> </paragraph> <paragraph num="(c)"> <text>Shall supervise not more than three limited licensees at one time; and</text> </paragraph> <paragraph num="(d)"> <text>May not have been formally disciplined by the Board within the previous 5 years.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An individual serving as a supervisor of a limited licensee is legally and ethically responsible for services provided or omitted by the limited licensee.</text> </paragraph> <paragraph num="(7)"> <text>Change in Supervisor or Place of Professional Employment.</text> <paragraph num="(a)"> <text>During the period of limited licensure, if an individual changes supervisor, or place of professional employment, or both, the individual shall submit a revised supervisory plan to the Board for Board approval.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall approve the new supervisor or the new setting before the individual may begin to practice under the new supervisor or in the new setting.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A supervisor shall notify the Board within 5 days if the supervisor withdraws from supervising a limited licensee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Supervision of Clinical Fellowship for Speech Pathologists.</text> <paragraph num="(1)"> <text>Supervisory Plan for Speech Pathologists.</text> <paragraph num="(a)"> <text>An applicant shall submit to the Board for approval a description of the supervisory plan to be followed during the period of limited licensure.</text> </paragraph> <paragraph num="(b)"> <text>The plan shall show adequate supervision, in accordance with this chapter.</text> </paragraph> <paragraph num="(c)"> <text>The Board may accept completion of the clinical fellowship required for the American Speech-Language-Hearing Association Certificate of Clinical Competence as meeting the requirements for supervised practice in this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless an exception is approved by the Board for extenuating circumstances, an applicant shall:</text> <paragraph num="(a)"> <text>Begin the clinical fellowship within 2 years after completion of the academic course work and clinical practicum requirements; and</text> </paragraph> <paragraph num="(b)"> <text>Complete the clinical fellowship within 24 months.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To complete a clinical fellowship, the applicant shall be employed as a professional in the field of speech-language pathology under appropriate supervision for not less than 9 months with a minimum of 30 hours of work per week. This requirement may also be met with part-time employment as follows:</text> <paragraph num="(a)"> <text>15—19 hours a week for a period of 18 months;</text> </paragraph> <paragraph num="(b)"> <text>20—24 hours a week for a period of 15 months; or</text> </paragraph> <paragraph num="(c)"> <text>25—29 hours a week for a period of 12 months.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At least 80 percent of the applicant's employment during the clinical fellowship shall be in direct client contact, which includes:</text> <paragraph num="(a)"> <text>Assessment/diagnosis/evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Screening, response to intervention (RTI), or observations of clients;</text> </paragraph> <paragraph num="(c)"> <text>Treatment, such as:</text> <paragraph num="(i)"> <text>Diagnostic assessment; and</text> </paragraph> <paragraph num="(ii)"> <text>Rehabilitation; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Activities related to client management, including:</text> <paragraph num="(i)"> <text>Writing reports and notes;</text> </paragraph> <paragraph num="(ii)"> <text>Billing;</text> </paragraph> <paragraph num="(iii)"> <text>Making rounds; and</text> </paragraph> <paragraph num="(iv)"> <text>Attendance at an individualized education program (IEP), individualized family service plan (IFSP) meeting, or other meetings related to the management of a client’s diagnosis and treatment plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>An individual serving as a supervisor:</text> <paragraph num="(a)"> <text>Shall hold a valid license issued by the Board in speech pathology, or if the supervisor is employed by a facility whose employees qualify for an exemption from licensure the Certificate of Clinical Competence of the American Speech-Language-Hearing Association in speech pathology;</text> </paragraph> <paragraph num="(b)"> <text>Shall have been in practice for a minimum of 2 years after completion of the clinical fellowship;</text> </paragraph> <paragraph num="(c)"> <text>May not supervise more than three limited licensees at one time;</text> </paragraph> <paragraph num="(d)"> <text>May not have been formally disciplined by the Board within the previous 5 years; and</text> </paragraph> <paragraph num="(e)"> <text>Shall provide a minimum of 4 hours per month for at least 9 months of supervisory activities during the clinical fellowship to include a minimum of 2 hours of other monitoring activities each month.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An individual serving as a supervisor of a limited licensee is legally and ethically responsible for services provided or omitted by the limited licensee.</text> </paragraph> <paragraph num="(7)"> <text>Change in Supervisor or Place of Professional Employment.</text> <paragraph num="(a)"> <text>During the period of limited licensure, if an individual changes supervisor, or place of professional employment, or both, the individual shall submit a revised supervisory plan to the Board for Board approval.</text> </paragraph> <paragraph num="(b)"> <text>The Board shall approve the new supervisor or the new setting before the individual may begin to practice under the new supervisor or in the new setting.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A supervisor shall notify the Board within 5 days if the supervisor withdraws from supervising a limited licensee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Full Licensure.</text> <paragraph num="(1)"> <text>Licensure Requirements for Audiologists.</text> <paragraph num="(a)"> <text>An individual may apply for full licensure if the individual fulfills all of the following requirements:</text> <paragraph num="(i)"> <text>The individual holds a current unsuspended and unrevoked certificate of licensure to practice audiology from another state or jurisdiction which was obtained by meeting requirements that are at least equivalent to the requirements of §D(2) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>The individual has completed the academic requirements, the supervised on-site direct clinical experience, the examination requirements as set forth in §D(2) of this regulation, and submits evidence of the successful completion of the clinical training.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The supervised post-graduate professional practice shall have been supervised by an individual who, at the time of supervision, held a valid audiology license issued by the Board, or if the supervisor is employed by a facility whose employees qualify for an exemption from licensure the Certificate of Clinical Competence of the American Speech-Language-Hearing Association or Board Certification in Audiology from the American Board of Audiology.</text> </paragraph> <paragraph num="(c)"> <text>The supervisor's license or certificate shall be in audiology.</text> </paragraph> <paragraph num="(d)"> <text>The applicant shall demonstrate oral English competency as follows:</text> <paragraph num="(i)"> <text>Completion of at least 60 credits from an undergraduate college or university where English was the language of instruction throughout the applicant's inclusive dates of attendance; or</text> </paragraph> <paragraph num="(ii)"> <text>Achievement of a minimum score of 105, with at least a 26 on Speaking and Listening, on the Test of English as a Foreign Language (TOEFL) within the 2 years preceding license application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Examination Requirements for Audiologists.</text> <paragraph num="(a)"> <text>An applicant shall have obtained a passing score on the National Examination in Audiology.</text> </paragraph> <paragraph num="(b)"> <text>If a passing score on the National Examination in Audiology was not obtained within the 5 years before applying for licensure, the applicant shall fulfill one or more of the following requirements as approved by the Board:</text> <paragraph num="(i)"> <text>Provide evidence that the applicant has practiced in audiology for 3 of the 5 years before applying for licensure;</text> </paragraph> <paragraph num="(ii)"> <text>Complete a period of supervised practice equivalent to that required of a limited licensee; or</text> </paragraph> <paragraph num="(iii)"> <text>Hold a current license in another state and submit proof of continuing education as stated in Regulation .06 of this chapter for the time period not practicing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A first time licensee, who has not held a full license in this State or another state for 1 full year, shall submit verification from the academic institution conferring the individual's degree attesting to the following:</text> <paragraph num="(a)"> <text>The academic course work completed by the individual applying for a license is consistent with the standards established by the Accreditation Commission for Audiology Education (ACAE) or the Council for Academic Accreditation (CAA); and</text> </paragraph> <paragraph num="(b)"> <text>The individual applying for licensure has completed 1,000 actual patient contact hours while working under direct on-site supervision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Licensure Requirements for Speech-Language Pathologists.</text> <paragraph num="(a)"> <text>An individual may apply for full licensure if the individual fulfills any of the following requirements:</text> <paragraph num="(i)"> <text>The individual holds a valid Certificate of Clinical Competence in speech-language pathology from the American Speech-Language-Hearing Association and meets the academic, practicum, examination, and supervised professional practice requirements of this chapter and the requirements of §D(5) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>The individual holds a current unsuspended and unrevoked certificate of licensure to practice speech-language pathology from another state or jurisdiction which was obtained by meeting requirements that are at least equivalent to the requirements of this State and that meet the requirements of §D(5) of this regulation; or</text> </paragraph> <paragraph num="(iii)"> <text>The individual has completed the academic requirements, the supervised direct clinical experience, the examination requirements as set forth in §D(5) of this regulation, and submits evidence of the successful completion of the clinical fellowship.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The supervised post-graduate professional practice shall have been supervised by an individual who, at the time of supervision, held a valid speech-language pathology license issued by the Board, or if the supervisor is employed by a facility whose employees qualify for an exemption from licensure, the Certificate of Clinical Competence of the American Speech-Language-Hearing Association.</text> </paragraph> <paragraph num="(c)"> <text>The supervisor's license or certificate shall be in the area of speech pathology.</text> </paragraph> <paragraph num="(d)"> <text>The applicant shall demonstrate oral English competency as follows:</text> <paragraph num="(i)"> <text>Completion of at least 60 credits from an undergraduate college or university where English was the language of instruction throughout the applicant's inclusive dates of attendance; or</text> </paragraph> <paragraph num="(ii)"> <text>Achievement of a minimum score of 105, with at least a 26 on Speaking and Listening, the Test of English as a Foreign Language (TOEFL) within the 2 years preceding license application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Examination Requirements for Speech-Language Pathologists.</text> <paragraph num="(a)"> <text>An applicant shall have obtained a passing score on the National Examination in Speech-Language Pathology.</text> </paragraph> <paragraph num="(b)"> <text>If a passing score on the National Examination in Speech-Language Pathology was not obtained within the 5 years before applying for licensure, the applicant shall fulfill one or more of the following requirements as approved by the Board:</text> <paragraph num="(i)"> <text>Provide evidence that the applicant has practiced in speech-language pathology for 3 of the 5 years before applying for licensure;</text> </paragraph> <paragraph num="(ii)"> <text>Complete a period of supervised practice equivalent to that required of a limited license; or</text> </paragraph> <paragraph num="(iii)"> <text>Hold a current speech-language pathologist license in another state and submit proof of continuing education as stated in Regulation .06 of this chapter for the time period not practicing.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Fees for Licensure."> <text>The fees for licensure shall be nonrefundable and may not be prorated. A license shall become effective on the date of issue.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewal of Licensure."> <paragraph num="A."> <text>Limited Licensure. A limited license shall be effective for 1 year from the date of issue and may be renewed once for one additional year on Board approval. The Board will renew a limited license if the limited licensee:</text> <paragraph num="(1)"> <text>Has not yet passed the national examination;</text> </paragraph> <paragraph num="(2)"> <text>Has a part-time supervised post-graduate position requiring additional weeks of employment; or</text> </paragraph> <paragraph num="(3)"> <text>Has a reason for renewal of the limited license that is acceptable to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Full Licensure.</text> <paragraph num="(1)"> <text>A license shall be renewed on or before May 31 of the year in which it expires.</text> </paragraph> <paragraph num="(2)"> <text>The applicant for license renewal is required to:</text> <paragraph num="(a)"> <text>Maintain evidence of satisfactory completion of continuing education requirements; and</text> </paragraph> <paragraph num="(b)"> <text>For an audiologist or hearing aid dispenser, submit proof of calibration for each audiometer in use within the previous 12-month period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensee who fails to complete the continuing education requirements within the time frame specified under Regulation .06 of this chapter may be subject to:</text> <paragraph num="(a)"> <text>Informal or formal discipline for failure to meet the requirements; and</text> </paragraph> <paragraph num="(b)"> <text>A monetary fine not to exceed $250.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensee shall undergo a new criminal records history check as set forth in Health Occupations Article, §2-303.1, Annotated Code of Maryland, every three renewal cycles or every 6 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Failure to Renew a License. A licensee who has failed to renew a license to practice in this State by June 30 of the year in which the license is due to be renewed is prohibited from practicing in this State.</text> </paragraph> <paragraph num="D."> <text>If the Board determines that a licensee has practiced in this State after the license has expired, the Board may:</text> <paragraph num="(1)"> <text>Order the licensee to immediately cease and desist practice in this State until the license has been reinstated by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Take action as follows against a licensee for unprofessional conduct if it determines that the licensee practiced in this State after the license has expired:</text> <paragraph num="(a)"> <text>Provide the licensee with a settlement conference; or</text> </paragraph> <paragraph num="(b)"> <text>Charge the licensee with unprofessional conduct as provided in Health Occupations Article, §2314(10), Annotated Code of Maryland, for practicing without a license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Continuing Education."> <paragraph num="A."> <text>Required Continuing Education Units.</text> <paragraph num="(1)"> <text>Within the 2-year renewal period immediately preceding the licensee's application for renewal, the licensee shall earn 30 continuing education units (CEUs) as follows:</text> <paragraph num="(a)"> <text>A minimum of 20 CEUs in the area of licensure that includes a minimum of 1 CEU in each of the following areas:</text> <paragraph num="(i)"> <text>Cultural competency; and</text> </paragraph> <paragraph num="(ii)"> <text>Ethics;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>No more than 10 CEUs in areas related to speech-language pathology or audiology or both, including practice management, that includes:</text> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(ii)"> <text>Billing; and</text> </paragraph> <paragraph num="(iii)"> <text>Interdisciplinary collaboration; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Related training that does not include annual training requirements for:</text> <paragraph num="(i)"> <text>Job orientation;</text> </paragraph> <paragraph num="(ii)"> <text>Job maintenance; or</text> </paragraph> <paragraph num="(iii)"> <text>Other general training or information related to human health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>It is recommended that a licensee applying for the renewal of a license successfully complete, within the 2-year licensing period as a part of the required 30 hours of Board-approved continuing education programs, a minimum of 2 CEUs in the area of supervision.</text> </paragraph> <paragraph num="(3)"> <text>Within the 2-year renewal period immediately preceding the licensee's application for renewal, an individual licensed as both an audiologist and a speech-language pathologist shall earn 40 CEUs as follows:</text> <paragraph num="(a)"> <text>A minimum of 15 CEUs in each area of licensure that includes a minimum of 1 CEU in each of the following areas:</text> <paragraph num="(i)"> <text>Cultural competency; and</text> </paragraph> <paragraph num="(ii)"> <text>Ethics;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>No more than 10 CEUs in areas related to speech-language pathology and audiology, including practice management, that includes:</text> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(ii)"> <text>Billing; and</text> </paragraph> <paragraph num="(iii)"> <text>Interdisciplinary collaboration; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Related training that does not include annual training requirements for:</text> <paragraph num="(i)"> <text>Job orientation;</text> </paragraph> <paragraph num="(ii)"> <text>Job maintenance; or</text> </paragraph> <paragraph num="(iii)"> <text>Other general training or information related to human health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>It is recommended that a licensee applying for the renewal of a license successfully complete, within the 2-year licensing period as a part of the required 30 hours of Board-approved continuing education programs, a minimum of 2 CEUs in the area of supervision.</text> </paragraph> <paragraph num="(5)"> <text>The Board shall notify the licensee 60 days before the date the license expires.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Time Period for CEUs.</text> <paragraph num="(1)"> <text>An audiologist licensee shall complete the required CEUs within the 2-year renewal period.</text> </paragraph> <paragraph num="(2)"> <text>A speech-language pathologist licensee shall complete the required CEUs within the 2-year period immediately preceding the license expiration.</text> </paragraph> <paragraph num="(3)"> <text>An individual licensed as both an audiologist and a speech-language pathologist shall complete the required CEUs within the 2-year period immediately preceding the license expiration.</text> </paragraph> <paragraph num="(4)"> <text>Continuing education units may not be carried over from one renewal period to the next.</text> </paragraph> <paragraph num="(5)"> <text>If the licensee presents evidence that failure to obtain the required CEUs was due to circumstances beyond the licensee's control, the Board may grant an extension of time to obtain the required CEUs.</text> </paragraph> <paragraph num="(6)"> <text>If the Board grants an extension of time to obtain the required CEUs, the Board may require the licensee to obtain, as additional CEUs, not more than twice the number of missing credits in order to renew the license.</text> </paragraph> <paragraph num="(7)"> <text>The Board may reduce or waive the continuing education requirements for an individual under extenuating circumstances.</text> </paragraph> <paragraph num="(8)"> <text>The Board shall waive all continuing education requirements for a speech-language pathologist or audiologist obtaining full licensure within 6 months of the renewal cycle. This includes newly licensed individuals, reinstatements, and transfers from other states.</text> </paragraph> <paragraph num="(9)"> <text>Continuing education units shall be prorated for licensees holding a full license for at least 6 months but less than 2 years during the renewal cycle. This includes newly licensed individuals, reinstatements, and transfers from other states.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Approval of Continuing Education Programs.</text> <paragraph num="(1)"> <text>The Board shall establish a committee to evaluate and approve continuing education programs.</text> </paragraph> <paragraph num="(2)"> <text>Providers of continuing education shall give a participant a certificate of completion which includes the following information:</text> <paragraph num="(a)"> <text>Date of completion;</text> </paragraph> <paragraph num="(b)"> <text>Course title;</text> </paragraph> <paragraph num="(c)"> <text>Name of participant;</text> </paragraph> <paragraph num="(d)"> <text>Name of provider; and</text> </paragraph> <paragraph num="(e)"> <text>Number of hours.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Not later than 30 days before a program, a provider of continuing education shall submit to the Board a:</text> <paragraph num="(a)"> <text>Request for approval of the program, using the form available on the Board’s website; and</text> </paragraph> <paragraph num="(b)"> <text>Biography for each course presenter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Individual Approval of Program.</text> <paragraph num="(a)"> <text>If a provider has not requested prior approval of a program, a licensee may apply to the Board for approval of continuing education units for the program, using the approved form available on the Board’s website.</text> </paragraph> <paragraph num="(b)"> <text>Not later than 30 days after a program, the licensee shall submit to the Board a request for approval of continuing education units for individual participation, using the approved form available on the Board’s website.</text> </paragraph> <paragraph num="(c)"> <text>If the activity directly concerns the practice of speech-language pathology or audiology, the licensee is not required to submit a request for approval of the program to the Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The following are examples of areas in which CEUs may be earned in activities concerning speech-language pathology and audiology:</text> <paragraph num="(a)"> <text>Academic course work in areas of speech-language pathology or audiology, or both, or related disciplines, taken at accredited colleges or universities where, along with the submission of an unofficial transcript and course description:</text> <paragraph num="(i)"> <text>15 CEU credit hours will be awarded for each 3 credit course earned;</text> </paragraph> <paragraph num="(ii)"> <text>10 CEU credit hours will be awarded for each 2 credit course earned; or</text> </paragraph> <paragraph num="(iii)"> <text>5 CEU credit hours will be awarded for each 1 credit course earned;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Lectures and scheduled courses or workshops at local, regional, national, or international conferences concerning speech-language pathology or audiology, or both;</text> </paragraph> <paragraph num="(c)"> <text>Attendance at lectures, workshops, or in-service programs;</text> </paragraph> <paragraph num="(d)"> <text>Other professional activities such as presentations, books, papers, or publications, where:</text> <paragraph num="(i)"> <text>1 hour of CEU credit may be earned by the presenter for each hour of presentation of a program, with a maximum of 3 CEUs;</text> </paragraph> <paragraph num="(ii)"> <text>10 hours of CEU credit may be earned for a professional or scientific paper prepared by the licensee or certificate holder, with a maximum per paper of 10 CEUs for the first author, 8 CEUs for the second author, 6 CEUs for the third author, and 4 CEUs for all other authors;</text> </paragraph> <paragraph num="(iii)"> <text>Authoring of a book chapter may earn a maximum of 10 CEUs, only in the year of publication; and</text> </paragraph> <paragraph num="(iv)"> <text>Editing or reviewing of a scientific or professional journal recognized by the Board, with a maximum of 8 CEUs for each year of service; or</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Attendance at regularly scheduled Board meetings where:</text> <paragraph num="(i)"> <text>1 hour of an open session of a Board meeting equals 1 hour of continuing education credit; and</text> </paragraph> <paragraph num="(ii)"> <text>Not more than 5 hours of continuing education credit may be earned in a single continuing education cycle.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Independent Study Activities.</text> <paragraph num="(a)"> <text>CEUs may be earned through independent study activities including:</text> <paragraph num="(i)"> <text>Professional journals which include post-tests to document completion;</text> </paragraph> <paragraph num="(ii)"> <text>Audio or video tapes of programs approved by the Board for continuing education credit with a post-test;</text> </paragraph> <paragraph num="(iii)"> <text>Internet programs approved by the Board for continuing education credit with a post-test; or</text> </paragraph> <paragraph num="(iv)"> <text>Other independent study activities approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The licensee shall complete the post-test successfully for CEUs to be granted.</text> </paragraph> <paragraph num="(c)"> <text>If proof of passing the post-test is obtained, there is no limit on the number of credit hours that may be earned through independent study activities.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Pro Bono Work.</text> <paragraph num="(a)"> <text>CEUs may be earned for pro bono work performed outside of a place of employment at the rate of 1 Maryland CEU per hour of Board-approved CEU activity, up to a maximum of 10 CEU credits in any single 2-year period.</text> </paragraph> <paragraph num="(b)"> <text>The licensee shall obtain approval from the Board for all pro bono work.</text> </paragraph> <paragraph num="(c)"> <text>The licensee shall provide the Board a written description of the proposed work not later than 60 days before beginning pro bono work. The description shall include:</text> <paragraph num="(i)"> <text>The place where the pro bono work will take place;</text> </paragraph> <paragraph num="(ii)"> <text>The type of work to be performed;</text> </paragraph> <paragraph num="(iii)"> <text>The number of hours of actual work to be performed for which the licensee desires CEU credit;</text> </paragraph> <paragraph num="(iv)"> <text>A description of how the work will enhance the licensee's ongoing education; and</text> </paragraph> <paragraph num="(v)"> <text>A statement guaranteeing that the licensee will not receive any financial gain from the work provided.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The licensee shall submit a written statement to the Board from the facility verifying the number of pro bono work hours completed.</text> </paragraph> <paragraph num="(e)"> <text>CEU credit may not be granted for work that did not receive prior approval from the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Documentation of CEUs.</text> <paragraph num="(1)"> <text>A licensee shall submit a signed form to the Board via mail or by electronic means attesting to the licensee’s completion of the required CEUs at the time of license renewal.</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall retain supporting documents for inspection by the Board for 4 years after the date of renewal.</text> </paragraph> <paragraph num="(3)"> <text>If a licensee submits the renewal form after the expiration date, the Board shall assess a late fee and may audit the licensee.</text> </paragraph> <paragraph num="(4)"> <text>Failure to meet continuing education requirements or failure to substantiate CEUs submitted upon request of the Board may result in suspension, revocation, or denial of licensure or other disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Continuing Education Audit Procedures.</text> <paragraph num="(1)"> <text>At each renewal period, the Board shall audit 10 percent of the renewal applications.</text> </paragraph> <paragraph num="(2)"> <text>The Board members shall be audited for the required CEUs.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall send notification of audit to licensees to be audited.</text> </paragraph> <paragraph num="(4)"> <text>The licensee being audited shall submit to the Board official certificates or transcripts via mail or by electronic means showing evidence of the continuing education hours required for renewal by the date indicated on the audit notification.</text> </paragraph> <paragraph num="(5)"> <text>The Board may take formal disciplinary action against the licensee, if the licensee:</text> <paragraph num="(a)"> <text>Submits a false statement of continuing education; or</text> </paragraph> <paragraph num="(b)"> <text>Fails to submit the required documents by the date indicated on an audit notification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Reactivation.</text> <paragraph num="(1)"> <text>If a license has been in an inactive status for no more than three 2-year renewal cycles of inactivity, the licensee may apply for reactivation of the inactive license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reactivate the license if the speech-pathologist or audiologist:</text> <paragraph num="(a)"> <text>Submits to the Board satisfactory proof of completion of at least 30 hours of CEU activity for every 2-year cycle of inactivity; and</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Board the renewal fee and the reactivation fee set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Reinstatement Requirement.</text> <paragraph num="(1)"> <text>If a license has been expired for 5 years or less, a speech-language pathologist or audiologist may apply for reinstatement of the expired license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reinstate the license if the speech-language pathologist or audiologist:</text> <paragraph num="(a)"> <text>Submits to the Board satisfactory proof of completion of at least 30 hours of CEU activity for every 2-year cycle of inactivity; and</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Board the renewal fee and the reinstatement fee set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Reapplication Requirement.</text> <paragraph num="(1)"> <text>The Board may not reinstate the license of a speech-language pathologist or audiologist who fails to apply for reinstatement of the license within 5 years after the license expires.</text> </paragraph> <paragraph num="(2)"> <text>The speech-language pathologist or audiologist whose license has been expired for more than 5 years may become licensed if the speech-language pathologist or audiologist:</text> <paragraph num="(a)"> <text>Meets the current requirements for obtaining a license;</text> </paragraph> <paragraph num="(b)"> <text>Submits to the Board satisfactory proof of completion of at least 30 hours of CEU activity for every 2-year cycle of inactivity, not to exceed 100 hours; and</text> </paragraph> <paragraph num="(c)"> <text>Pays to the Board the application fee set by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensee Responsibilities."> <paragraph num="A."> <text>A licensee shall notify the Board in writing of a change of:</text> <paragraph num="(1)"> <text>Mailing address within 30 days after the change;</text> </paragraph> <paragraph num="(2)"> <text>Name within 30 days after the change; or</text> </paragraph> <paragraph num="(3)"> <text>Email address within 30 days after the change if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee who fails to comply with the requirements of this regulation may be subject to disciplinary action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Incomplete Applications."> <paragraph num="A."> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after receipt of an incomplete application of the materials that are required.</text> </paragraph> <paragraph num="B."> <text>An application is not complete until all required material, including the application fee and supporting documentation, is received by the Board.</text> </paragraph> <paragraph num="C."> <text>If the applicant fails to provide the required documentation within 1 year of receipt of the initial receipt, the Board may administratively close the application.</text> </paragraph> <paragraph num="D."> <text>An applicant whose application is administratively closed may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(1)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(2)"> <text>Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205, 2-302, 2-302.2, 2-304, 2-305, 2-308, 2-310, 2-310.2, 2-311(c), 2-312 (b), 2-314(11), and 2-314.9, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 21, 1980 (7:6 Md. R. 609)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 20, 2008 (35:20 Md. R. 1824); March 23, 2009 (36:6 Md. R. 492); April 18, 2011 (38:8 Md. R. 506); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 19, 1994 (21:25 Md. R. 2106); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 7, 1983 (10:22 Md. R. 1966); June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective December 11, 2003 (30:24 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, D amended effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective September 17, 2012 (39:18 Md. R. 1197); March 17, 2014 (41:5 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 7, 1983 (10:22 Md. R. 1966); December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, amended effective December 11, 2003 (30:24 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective October 28, 2013 (40:21 Md. R. 1775); June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, D amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C, D adopted effective June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 7, 1983 (10:22 Md. R. 1966);</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective December 19, 1994 (21:25 Md. R. 2106)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 11, 2003 (30:24 Md. R. 1742); August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective May 30, 2011 (38:11 Md. R. 672); April 2, 2012 (39:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective January 28, 2008 (35:2 Md. R. 127); March 23, 2009 (36:6 Md. R. 492); September 19, 2011 (38:19 Md. R. 1147); April 2, 2012 (39:6 Md. R. 409)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective March 23, 2009 (36:6 Md. R. 492); January 7, 2013 (39:26 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective February 27, 2017 (44:4 Md. R. 255)</annotation> </annotations> </chapter> <chapter num="04" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>means the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference committee” means a committee composed of one or more members of the Board that makes recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(7)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of audiology, hearing aid dispensing, speech-language pathology, or music therapy.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Charging document” means a nonpublic document issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth provisions of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Complaint” means a written allegation or other information received by the Board that a licensee may have violated the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Consent order” means a public record issued by the Board that is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(11)"> <text>“Contested case” means a proceeding conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(12)"> <text>“Disposition agreement” means a formal nonpublic agreement, entered into with an impaired licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(13)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may do by law.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Imperatively requires emergency action” means a finding by the Board that an emergency action be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(15)"> <text>“Informal action” means that the Board closes a case without taking formal disciplinary action or without issuing a final order, by imposing a disciplinary sanction consisting of a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment;</text> </paragraph> <paragraph num="(c)"> <text>Cease and desist letter; or</text> </paragraph> <paragraph num="(d)"> <text>Consent agreement.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Investigation” means the gathering of information to assist the Board in determining if there is reasonable cause to charge a licensee with a violation of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act.</text> </paragraph> <paragraph num="(17)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing a case, if the Board believes a licensee has engaged in conduct that violates the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act, admonishing the licensee not to repeat the conduct.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may include an agreement that licensee perform certain conditions instead of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Letter of education” means informal action consisting of a nonpublic letter to a licensee:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of audiology, hearing aid dispensing, speech-language pathology, or music therapy.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the license to practice audiology, hearing aid dispensing, speech-language pathology, or music therapy.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Licensure” means permission to engage in the practice of audiology, hearing aid dispensing, speech-language pathology, or music therapy which is evidenced by a license issued by the Board.</text> </paragraph> <paragraph num="(21)"> <text>“Maryland Audiologists, Hearing Aid Dispensers, Speech Language Pathologists, and Music Therapists Act” means Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Notice of initial denial” means a nonpublic document issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, a change in licensure status, or some other benefit sought by the licensee.</text> </paragraph> <paragraph num="(23)"> <text>“Postdeprivation hearing” means a show cause hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(24)"> <text>“Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why the Board should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action that the Board may take by law.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Preliminary investigation” means the gathering of information to be used by the Board to determine if the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act.</text> </paragraph> <paragraph num="(26)"> <text>“Probation” means a sanction imposed by the Board in a public final order in which the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Prohibited act” means conduct specified in the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act which may result in sanctions or penalties.</text> </paragraph> <paragraph num="(28)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Recommended decision” means a nonpublic document issued to the Board by an administrative law judge that sets out proposed findings of fact, proposed conclusions of law, proposed sanction, or any combination of them.</text> </paragraph> <paragraph num="(30)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in a case.</text> </paragraph> <paragraph num="(31)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, that has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential emergency suspension under State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Notified as to a potential violation of Health Occupations Article, §2-401, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Revocation” means the removal of an audiologist’s, hearing aid dispenser’s, speech-language pathologist’s, or music therapist’s license to practice audiology, hearing aid dispensing, speech-language pathology, or music therapy.</text> </paragraph> <paragraph num="(33)"> <text>“Sanction” means an action by the Board, including a:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Placement on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fine; or</text> </paragraph> <paragraph num="(d)"> <text>Suspension or revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Show cause hearing” means a nonevidentiary hearing before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board may take.</text> </paragraph> <paragraph num="(35)"> <text>“Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions.</text> </paragraph> <paragraph num="(36)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, taken if the Board believes the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(37)"> <text>“Surrender” means the voluntary relinquishing of a license to practice audiology, hearing aid dispensing, speech-language pathology, or music therapy that may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(38)"> <text>“Suspension” means a temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specific period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Violation” means an act or omission prohibited under Health Occupations Article, §2-314, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this regulation.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings' proceedings involving the adjudication of a Board-contested case and the administrative law judge's recommended decision are confidential. The respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is issued by the Board, the parties may not reveal legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, the respondent shall be represented in proper person or by an attorney who has been admitted to the Maryland Bar or specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>In all proceedings, the Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings under Health Occupations Article, §2-314, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Make a preliminary review of each complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Recommend that cases involving complaints over which the Board lacks jurisdiction be closed or referred to the appropriate agency.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee that is the subject of the complaint, to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(3)"> <text>Board subpoenas may be issued by the Board over the signature of the administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>After reviewing any completed investigative information or reports for each complaint, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(c)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(d)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(e)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(f)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §2-314, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether the Board has voted to charge a licensee with violations of the Maryland Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(a)"> <text>Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Hand-delivered in person; or</text> </paragraph> <paragraph num="(c)"> <text>Served by other means reasonable to effect service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> <paragraph num="(4)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party, not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness that will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §D(2)(a) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments on the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §D(2)(a)(ii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(a)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>15 or fewer days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, if possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in §E(1) of this regulation, the Board may deny a respondent's request for a case resolution conference.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or introduced by appropriate means.</text> </paragraph> <paragraph num="(5)"> <text>Recommendations of the case resolution conference committee are not binding on the Board, which may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>The Board may require conditions for surrender of a license, including:</text> <paragraph num="(a)"> <text>An admission of a violation of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act;</text> </paragraph> <paragraph num="(b)"> <text>An admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the Board determines that disclosure of the surrender is not in the public interest, a letter of surrender is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings on a case-by-case basis.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings may not be open to the public.</text> </paragraph> <paragraph num="(4)"> <text>All records, including the recommended decision, shall be confidential and sealed.</text> </paragraph> <paragraph num="(5)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §B(5)(a)—(c) of this regulation pursuant to the Board's delegation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>An applicant or licensee issued a notice of initial denial by the Board has the burden to demonstrate by a preponderance of the evidence that the applicant or licensee is entitled to licensure or other benefit the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise permitted by the Board, within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages, and shall state with particularity the finding of fact, conclusion of law, or other matter excepted to, and the relevant portions of the record supporting the party's exception.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise permitted by the Board, within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party's response to an answer to exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties' exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient progress of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The respondent and the administrative prosecutor each may not exceed 30 minutes to present oral argument.</text> </paragraph> <paragraph num="(f)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in an answer to exceptions or in the hearing on exceptions, reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>Upon a finding that there has been a violation of the Maryland Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Pursuant to its authority under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact that the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed to prosecute the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity to be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>A Predeprivation Show Cause Hearing before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides at the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious, if the presiding Board member believes that the documents or exhibits are necessary for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension Without Prior Notice or an Opportunity to be Heard.</text> <paragraph num="(1)"> <text>Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend license or providing a respondent with an opportunity for a predeprivation hearing if the Board determines that:</text> <paragraph num="(a)"> <text>The public health, safety, or welfare requires the immediate suspension of the license; and</text> </paragraph> <paragraph num="(b)"> <text>Prior notice and an opportunity to be heard are not feasible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Time — Service and Hearing.</text> <paragraph num="(a)"> <text>An order of summary suspension under §D(1) of this regulation shall be served upon the respondent within 24 hours after its execution.</text> </paragraph> <paragraph num="(b)"> <text>The respondent shall be provided an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall:</text> <paragraph num="(a)"> <text>Be conducted before the Board as provided in §D(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Postdeprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license under §C or D of this regulation, the respondent shall have an opportunity for an evidentiary hearing before the Board, or if the Board delegates the matter to the Office of Administrative Hearings, before an administrative law judge.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after respondent's request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts which form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge shall issue a recommended decision to the Board with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a) — (c) of this regulation, pursuant to the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge's determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exceptions to the recommended decision, as provided in State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a postdeprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board considers appropriate, including but not limited to:</text> <paragraph num="(1)"> <text>Reeducation or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Providing free audiology, hearing aid dispensing, speech-language pathology, or music therapy services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Practicing under supervision;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring by the Board or by an individual or entity approved by the Board, with periodic reporting to the Board;</text> </paragraph> <paragraph num="(6)"> <text>Periodic review of a licensee's clinical practices or billing;</text> </paragraph> <paragraph num="(7)"> <text>Periodic audits of a licensee's billing practices;</text> </paragraph> <paragraph num="(8)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(10)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(11)"> <text>Any other condition the Board considers appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when:</text> <paragraph num="(1)"> <text>The specific period of time has passed;</text> </paragraph> <paragraph num="(2)"> <text>The licensee has successfully completed the conditions or acts required for termination; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action the final order or consent order provides for a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts that constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .05E of this chapter.</text> </paragraph> <paragraph num="G."> <text>If the Board determines that a respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action the consent order or final order provides for a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a sanction or take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Restoration of a License."> <paragraph num="A."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for termination of a suspension of a license or a reinstatement after revocation or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee that petitions the Board for reinstatement under the terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board, shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(3)"> <text>A licensee whose license has been revoked or surrendered for 5 or more years before filing a petition for reinstatement is ineligible for reinstatement but may apply for initial licensure.</text> </paragraph> <paragraph num="(4)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Notice of an Opportunity for a Hearing.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, that notice shall be served as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the legal basis for the Board's belief that the applicant is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts the Board believes support the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or delegated to an administrative law judge and conducted under the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, the Board may impose any restrictions or conditions on the license or the licensee's practice that it considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §2-316, Annotated Code of Maryland and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Fines."> <paragraph num="A."> <text>This regulation establishes the standards by which the Board may impose a fine not exceeding $1,000.</text> </paragraph> <paragraph num="B."> <text>After a hearing under Health Occupations Article, §2-315, Annotated Code of Maryland, and COMAR 10.41.04, the Board may impose a fine, in addition to, or instead of:</text> <paragraph num="(1)"> <text>Reprimanding a licensee;</text> </paragraph> <paragraph num="(2)"> <text>Placing a licensee on probation; or</text> </paragraph> <paragraph num="(3)"> <text>Suspending or revoking a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In determining whether to impose a fine and the amount of the fine, the Board shall consider the following factors:</text> <paragraph num="(1)"> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="(2)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(3)"> <text>The extent to which the individual derived a financial benefit from the violation;</text> </paragraph> <paragraph num="(4)"> <text>The history of a previous violation or violations;</text> </paragraph> <paragraph num="(5)"> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="(6)"> <text>Mitigating factors as presented by the licensee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual shall pay the fine to the Board under the terms of the Board's order.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all money collected under this chapter to the General Fund of the State.</text> </paragraph> <paragraph num="F."> <text>Unless the Board's order provides otherwise, if an individual fails to pay, in whole or in part, a fine imposed by the Board, the Board may not restore, reinstate, or renew the license of the individual until the individual pays the fine in full.</text> </paragraph> <paragraph num="G."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205, 2-313, and 2-315; State Government Article §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 28, 1987 (14:26 Md. R. 2748)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 27, 2000 (27:23 Md. R. 2149)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 27, 2000 (27:23 Md. R. 2149)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 27, 2000 (27:23 Md. R. 2149)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.11 adopted effective March 31, 2003 (30:6 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, C, E amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> <chapter num="05" heading="Music Therapy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all persons licensed as music therapists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(2)"> <text>“CBMT-certified” means a music therapist who:</text> <paragraph num="(a)"> <text>Is currently certified by the Certification Board for Music Therapists; and</text> </paragraph> <paragraph num="(b)"> <text>Has completed the educational and clinical training requirements established by the American Music Therapy Association.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Individualized music therapy treatment plan” means a music therapy treatment plan for a client that identifies the goals, objectives, and potential strategies for the music therapy services appropriate for the client using music therapy interventions, including:</text> <paragraph num="(a)"> <text>Music improvisation;</text> </paragraph> <paragraph num="(b)"> <text>Receptive music listening;</text> </paragraph> <paragraph num="(c)"> <text>Songwriting;</text> </paragraph> <paragraph num="(d)"> <text>Lyric discussion;</text> </paragraph> <paragraph num="(e)"> <text>Music and imagery;</text> </paragraph> <paragraph num="(f)"> <text>Music performance;</text> </paragraph> <paragraph num="(g)"> <text>Learning through music; and</text> </paragraph> <paragraph num="(h)"> <text>Movement to music.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Licensed professional music therapist” means an individual who is licensed by the Board to engage in the practice of music therapy.</text> </paragraph> <paragraph num="(5)"> <text>“Practice of music therapy” has the meaning stated in Health Occupations Article, §2-4A-01, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure Requirements."> <paragraph num="A."> <text>To qualify for a license, an applicant shall be an individual who meets the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be at least 18 years old;</text> </paragraph> <paragraph num="(3)"> <text>Be a CBMT-certified music therapist;</text> </paragraph> <paragraph num="(4)"> <text>Provide proof of:</text> <paragraph num="(a)"> <text>Passing the examination for certification offered by the Certification Board for Music Therapists (CBMT) or any successor organization approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Being transitioned into Board licensure and that the applicant is currently a CBMT-certified music therapist;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Hold a bachelor’s degree or higher in music therapy, or its equivalent, including clinical training, from an educational program that is:</text> <paragraph num="(a)"> <text>Approved by the American Music Therapy Association or any successor organization; and</text> </paragraph> <paragraph num="(b)"> <text>Within an accredited college or university;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Be in good standing based on a review of the applicant’s music therapy licensure, certification, or registration history in other jurisdictions, including a review of any disciplinary actions in the practice of music therapy; and</text> </paragraph> <paragraph num="(7)"> <text>Meet any other requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To apply for a license, an applicant shall:</text> <paragraph num="(1)"> <text>Submit an application to the Board on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the application fee set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submit to a criminal history records check in accordance with Health Occupations Article, §2–303.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall issue a license to any applicant who meets the requirements of:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 2, Subtitle 4A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>§C of this regulation and provides evidence satisfactory to the Board that the applicant is licensed and in good standing as a music therapist in another jurisdiction where the qualifications required are equal to or greater than those required in this subtitle.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall include on each license that the Board issues:</text> <paragraph num="(1)"> <text>The full name of the licensed music therapist;</text> </paragraph> <paragraph num="(2)"> <text>The dates of issuance and expiration; and</text> </paragraph> <paragraph num="(3)"> <text>A license number.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A music therapist license authorizes the licensee to engage in the practice of music therapy while the license is effective.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Renewal of Licensure."> <paragraph num="A."> <text>A license expires on a date set by the Board unless the license is renewed for an additional term as set forth under §D of this regulation.</text> </paragraph> <paragraph num="B."> <text>A license may not be renewed for a term longer than 2 years.</text> </paragraph> <paragraph num="C."> <text>At least 1 month before a license expires, the Board shall send to the licensee, by first-class mail or email to the last known address of the licensee, a renewal notice that states the:</text> <paragraph num="(1)"> <text>Expiration date;</text> </paragraph> <paragraph num="(2)"> <text>Due date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before a license expires, the licensee periodically may renew the license for an additional term if the licensee:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a renewal fee set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with any continuing education requirements established by the Board under Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee shall undergo a new criminal records history check as set forth in Health Occupations Article, §2-303.1, Annotated Code of Maryland, every three renewal cycles or every 6 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Continuing Education Requirements."> <paragraph num="A."> <text>The continuing education requirements shall include proof of completion of at least 40 hours of continuing education in a program approved by CBMT or any successor organization approved by the Board that includes:</text> <paragraph num="(1)"> <text>A minimum of 1 CEU in the area of cultural competency;</text> </paragraph> <paragraph num="(2)"> <text>A minimum of 1 CEU in the area of ethics;</text> </paragraph> <paragraph num="(3)"> <text>Supervision;</text> </paragraph> <paragraph num="(4)"> <text>Billing;</text> </paragraph> <paragraph num="(5)"> <text>Interdisciplinary collaboration; and</text> </paragraph> <paragraph num="(6)"> <text>Related training that does not include annual training requirements for:</text> <paragraph num="(a)"> <text>Job orientation;</text> </paragraph> <paragraph num="(b)"> <text>Job maintenance; or</text> </paragraph> <paragraph num="(c)"> <text>Other general training or information related to human health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>It is recommended that a licensee applying for the renewal of a license successfully complete, within the 2-year licensing period as a part of the required 40 hours of Board-approved continuing education programs, a minimum of 2 CEUs in the area of supervision.</text> </paragraph> <paragraph num="C."> <text>The Board shall renew the license of each licensee who meets the requirements of Regulations .04 and .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inactive Status, Reactivation, Reinstatement, and Reapplication."> <paragraph num="A."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>The Board shall place a licensee on inactive status if the licensee submits to the Board:</text> <paragraph num="(a)"> <text>An application for inactive status on the form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>The inactive status fee set by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall license an individual on inactive status who applies for a license if the individual meets:</text> <paragraph num="(a)"> <text>The renewal requirements of Health Occupations Article, §2–4A–10, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Any continuing education requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may not require payment of a late fee by an individual as a condition to licensing set forth under §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reactivation.</text> <paragraph num="(1)"> <text>If a license has been in an inactive status for no more than two 2-year renewal cycles of inactivity, the licensee may apply for reactivation of the inactive license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reactivate the license if the music therapist:</text> <paragraph num="(a)"> <text>Submits to the Board satisfactory proof of completion of at least 40 hours of CEU activity, in a program approved by CBMT or any successor organization, for every 2-year cycle of inactivity; and</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Board the renewal fee and the reactivation fee set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>If a license has been expired for 5 years or less, a music therapist may apply for reinstatement of the expired license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reinstate the license if the music therapist:</text> <paragraph num="(a)"> <text>Submits to the Board satisfactory proof of completion of continuing education hours required of a music therapist on active status during the period of inactivity; and</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Board the renewal fee and the reinstatement fee set by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reapplication.</text> <paragraph num="(1)"> <text>The Board may not reinstate the license of a music therapist who fails to apply for reinstatement of the license within 5 years after the license expires.</text> </paragraph> <paragraph num="(2)"> <text>The music therapist whose license has been expired for more than 5 years may become licensed if the music therapist:</text> <paragraph num="(a)"> <text>Meets the current requirements for obtaining a license;</text> </paragraph> <paragraph num="(b)"> <text>Submits to the Board satisfactory proof of completion of continuing education hours required of a music therapist on active status during the period of inactivity; and</text> </paragraph> <paragraph num="(c)"> <text>Pays to the Board the application fee set by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensee Responsibilities."> <paragraph num="A."> <text>A licensee shall notify the Board in writing of a change of:</text> <paragraph num="(1)"> <text>Mailing address within 30 days after the change;</text> </paragraph> <paragraph num="(2)"> <text>Name within 30 days after the change; or</text> </paragraph> <paragraph num="(3)"> <text>Email address within 30 days after the change if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee who fails to comply with the requirements of this regulation may be subject to disciplinary action.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-101, 2-201, 2-202(a), 2-206(a) and (d)(2), 2-501, and 2-4A-01—2-4A-25, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective November 10, 2003 (30:22 Md. R. 1582)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective March 23, 2009 (36:6 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">New Regulations .01-.07 adopted under new chapter Music Therapy effective August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> <chapter num="06" heading="Telehealth Communication"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of audiology, hearing aid dispensing, speech-language pathology, and music therapy using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“In-person” means in the physical presence of the patient.</text> </paragraph> <paragraph num="(4)"> <text>“Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology.</text> </paragraph> <paragraph num="(5)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Telehealth practitioner” means:</text> <paragraph num="(a)"> <text>A Maryland licensee of the Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists performing telehealth services within their respective scope of practice; or</text> </paragraph> <paragraph num="(b)"> <text>An audiologist or speech-language pathologist with a compact privilege in Maryland performing telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, Title 2, Subtitle 3, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland or hold a compact privilege when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Contact information;</text> </paragraph> <paragraph num="(c)"> <text>Maryland license number and type or compact privilege number, if applicable; and</text> </paragraph> <paragraph num="(d)"> <text>Medical specialty, if applicable;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Except for interpretive services, obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks and benefits of the services to be provided;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person health care settings.</text> </paragraph> <paragraph num="D."> <text>The requirements set forth under §§A and B of this regulation may be delegated.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>Except when providing asynchronous telehealth services or remote patient monitoring, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Perform a clinical patient evaluation adequate to establish a diagnosis and identify underlying conditions or contraindications to recommended treatment options before providing treatment or services through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person health care services; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the evaluation is adequate to comply with §A of this regulation, a telehealth practitioner may use:</text> <paragraph num="(1)"> <text>Telehealth devices;</text> </paragraph> <paragraph num="(2)"> <text>Live synchronous audio-visual communication;</text> </paragraph> <paragraph num="(3)"> <text>Other methods of performing a patient examination remotely; or</text> </paragraph> <paragraph num="(4)"> <text>A patient evaluation performed by another licensed health care practitioner providing coverage.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall comply with all applicable laws and regulations governing referrals, testing, and evaluation of patients including, but not limited to, the requirements of:</text> <paragraph num="(1)"> <text>COMAR 10.41.08; and</text> </paragraph> <paragraph num="(2)"> <text>Health Occupations Article, §2-314.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A telehealth practitioner may not treat a patient based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with Regulations .04 and .05 of this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-201 and 2-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 20, 2008 (35:21 Md. R. 1824</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed and new regulations .01—.06 adopted effective September 18, 2023 (50:18 Md. R. 796)</annotation> </annotations> </chapter> <chapter num="07" heading="Cerumen Management"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern persons licensed as audiologists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Cerumen management” means the removal of cerumen which may affect the successful completion of audiological procedures.</text> </paragraph> <paragraph num="(2)"> <text>“Medical liaison” means a cooperative arrangement for consultation with a physician, preferably an otolaryngologist.</text> </paragraph> <paragraph num="(3)"> <text>“Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Limitations."> <paragraph num="A."> <text>Before the removal of cerumen, the licensee shall obtain the informed consent of the patient, or legally responsible adult, and maintain documentation.</text> </paragraph> <paragraph num="B."> <text>During cerumen removal, the licensee shall comply with the principles of universal precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Training, Knowledge, and Skills."> <paragraph num="A."> <text>The licensee shall be responsible for obtaining the training, knowledge, and skills necessary to perform cerumen management.</text> </paragraph> <paragraph num="B."> <text>Failure to obtain the training before performing cerumen management may subject the licensee to disciplinary action.</text> </paragraph> <paragraph num="C."> <text>The licensee shall obtain training that includes:</text> <paragraph num="(1)"> <text>Principles of cerumen management including the anatomy of the ear canal and the ear drum and classification of cerumen;</text> </paragraph> <paragraph num="(2)"> <text>Use of instruments;</text> </paragraph> <paragraph num="(3)"> <text>Techniques for cerumen removal;</text> </paragraph> <paragraph num="(4)"> <text>Recognition of complications;</text> </paragraph> <paragraph num="(5)"> <text>Recognition of contraindications including but not limited to:</text> <paragraph num="(a)"> <text>Only hearing ear;</text> </paragraph> <paragraph num="(b)"> <text>Perforated tympanic membrane;</text> </paragraph> <paragraph num="(c)"> <text>Inflammation, tenderness, or drainage from the ear canal or middle ear;</text> </paragraph> <paragraph num="(d)"> <text>Ear surgery within the past 6 months or tympanostomy tubes;</text> </paragraph> <paragraph num="(e)"> <text>Diabetes mellitus, HIV infection, bleeding disorder, or other medical contraindications;</text> </paragraph> <paragraph num="(f)"> <text>Actual or suspected foreign body;</text> </paragraph> <paragraph num="(g)"> <text>Stenosis or bony exostosis of the ear canal;</text> </paragraph> <paragraph num="(h)"> <text>Dizziness occurring during cerumen removal;</text> </paragraph> <paragraph num="(i)"> <text>Cerumen impaction that totally occludes the ear canal; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Clinical experience gained under the direct supervision of a qualified professional.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The licensee shall maintain documentation evidencing the satisfactory completion of the required training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Precautions."> <paragraph num="A."> <text>The licensee shall have established a medical liaison as defined in Regulation .02B of this chapter before performing cerumen removal.</text> </paragraph> <paragraph num="B."> <text>The licensee shall refer patients to or consult with as needed the medical liaison for patients requiring cerumen removal who exhibit contraindications.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-101(n) and 2-205(a)(1), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 18, 1995 (22:25 Md. R. 1962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 6, 2005 (31:26 Md. R. 1863)</annotation> </annotations> </chapter> <chapter num="08" heading="Hearing Aid Dispensing"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs individuals holding a license or a limited license as a hearing aid dispenser in the State.</text> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited 2-year post-secondary program” means:</text> <paragraph num="(a)"> <text>A college or university located in the United States whose program has been accredited by a national accrediting association recognized by the:</text> <paragraph num="(i)"> <text>Council for Higher Education Accreditation; or</text> </paragraph> <paragraph num="(ii)"> <text>The United State Department of Education; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A college or university located outside of the United States whose program has met the standards for certification of the governing educational body that is regulated by the government of the country where the college or university is located.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Locked, nonproprietary programming software” means software that any provider can render inaccessible to other hearing aid programmers.</text> </paragraph> <paragraph num="(3)"> <text>“Pro bono work” means work provided within the State within the scope of practice of the licensee that is performed without financial reimbursement or direct financial gain.</text> </paragraph> <paragraph num="(4)"> <text>“Proprietary programming software” means software that is:</text> <paragraph num="(a)"> <text>Used to program hearing aids that is supplied by a hearing aid distributor or manufacturer for the exclusive use by affiliated providers; and</text> </paragraph> <paragraph num="(b)"> <text>Locked and inaccessible to nonaffiliated providers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application for License."> <paragraph num="A."> <text>The Board shall forward the necessary form to an individual requesting an application for a license or a limited license as a hearing aid dispenser.</text> </paragraph> <paragraph num="B."> <text>The applicant shall provide the Board with the information necessary to satisfy the Board that the requirements are being fulfilled.</text> </paragraph> <paragraph num="C."> <text>Failure to complete the forms and to provide the information required may be cause for the application to be rejected by the Board.</text> </paragraph> <paragraph num="D."> <text>The applicant shall include with the application:</text> <paragraph num="(1)"> <text>The application fee;</text> </paragraph> <paragraph num="(2)"> <text>Documentation regarding supervision of the limited license, if applicable;</text> </paragraph> <paragraph num="(3)"> <text>An official transcript from the accredited 2-year post-secondary program, as defined in Regulation .01-1B of this chapter, attended by the applicant; and</text> </paragraph> <paragraph num="(4)"> <text>All other required documentation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The application fee covers the cost of administration and is not refundable.</text> </paragraph> <paragraph num="F."> <text>The Board shall include in the application for a limited license the following statement: “I do hereby affirm, under penalty of perjury, that I am the holder of a valid unrevoked, unsuspended license issued by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists and that I have read the above excerpts, and that I fully understand my responsibilities as supervisor for the applicant who will work and train under my supervision and for whose technical training and ethical conduct I am to be responsible. I further affirm that I have read the application of the above-named person and that to the best of my knowledge all answers are true and correct.”</text> </paragraph> <paragraph num="G."> <text>The holder of a current hearing aid dispenser license who serves as the supervisor for the applicant shall sign the statement quoted in §F of this regulation.</text> </paragraph> <paragraph num="H."> <text>False Information.</text> <paragraph num="(1)"> <text>An applicant furnishing false information in the application may be denied the right to the examination.</text> </paragraph> <paragraph num="(2)"> <text>If the applicant has been issued a license before the falsity of the information is discovered by the Board, the licensee may be subject to:</text> <paragraph num="(a)"> <text>Suspension;</text> </paragraph> <paragraph num="(b)"> <text>Revocation; or</text> </paragraph> <paragraph num="(c)"> <text>Prosecution for fraud, perjury, or both.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>The applicant shall demonstrate oral English competency as follows:</text> <paragraph num="(1)"> <text>Completion of at least 60 credits from an undergraduate college or university where English was the language of instruction throughout the applicant's inclusive dates of attendance; or</text> </paragraph> <paragraph num="(2)"> <text>Achievement of a minimum score of 105, with at least a 26 on Speaking and Listening, on the Test of English as a Foreign Language (TOEFL) within the 2 years preceding license application.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Upon approval of an application, the Board shall issue a document authorizing the applicant to practice in this State in accordance with Health Occupations Article, §2-306, Annotated Code of Maryland, and the regulations in this chapter.</text> </paragraph> <paragraph num="K."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after receipt of an incomplete application of the materials that are required.</text> </paragraph> <paragraph num="(2)"> <text>An application is not complete until all required material, including the application fee and supporting documentation, is received by the Board.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide the required documentation within 1 year of receipt of the initial receipt, the Board may administratively close the application.</text> </paragraph> <paragraph num="(4)"> <text>An applicant whose application is administratively closed may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examinations — General."> <paragraph num="A."> <text>An applicant shall file the examination application with the Board at least 30 days before the date of the examination.</text> </paragraph> <paragraph num="B."> <text>Except for an applicant who holds a valid license to provide hearing aid dispenser services in another state or an applicant who holds a valid license to practice medicine in this State or any other state, the applicant shall obtain 6 months training under the supervision of a licensed hearing aid dispenser before taking the examination given by the Board.</text> </paragraph> <paragraph num="C."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Require that an applicant, who holds a valid license to practice medicine in this State or any other state and intends to sell hearing aids at retail, pass the written and law examinations given by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Request that an applicant, who holds a valid license to practice medicine in this State or any other state and intends to sell hearing aids at retail, take the practical examination given by the Board to ensure adequate protection to the consumer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall accept current National Board Certification as a Hearing Instrument Specialist (BC-HIS) instead of the written and practical examinations for licensure, if the applicant:</text> <paragraph num="(1)"> <text>Is currently licensed in good standing in the state from which the applicant is applying; and</text> </paragraph> <paragraph num="(2)"> <text>Has practiced 3 years of the last 5 years before applying for a license in this State.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Before taking the Hearing Aid Dispensing Examination, a candidate shall provide the Board with a certificate of completion of the International Hearing Society course entitled “Distance Learning for the Professional in Hearing Health Sciences”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conduct of the Examination."> <paragraph num="A."> <text>The Board shall select the site for the examination.</text> </paragraph> <paragraph num="B."> <text>An applicant may not be examined by an examiner by whom the applicant is employed or with whom the applicant has a contractual relationship.</text> </paragraph> <paragraph num="C."> <text>The Board shall ensure that the content and scope of the examination is in accordance with Health Occupations Article, §2-304, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Board shall provide the applicant with up-to-date information as to study or reference material which would be beneficial in preparing for the examination.</text> </paragraph> <paragraph num="E."> <text>The Board shall treat cheating or dishonesty by an applicant as grounds for failure.</text> </paragraph> <paragraph num="F."> <text>At the time of the examination, the Board shall provide each applicant with an identification number to be used on the examination papers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Scope of the Examination."> <paragraph num="A."> <text>The Board shall ensure that the examination consists of a written part and a practical part.</text> </paragraph> <paragraph num="B."> <text>The written examination shall utilize the most recent competency model licensing examination from the Education Division of the International Hearing Society.</text> </paragraph> <paragraph num="C."> <text>The Board shall ensure that the practical part of the examination tests proficiency in:</text> <paragraph num="(1)"> <text>Pure tone audiometry, including testing and recording of air and bone conduction;</text> </paragraph> <paragraph num="(2)"> <text>Speech audiometry, including speech reception and speech discrimination testing;</text> </paragraph> <paragraph num="(3)"> <text>Masking methodology;</text> </paragraph> <paragraph num="(4)"> <text>Choice and adaptation of hearing aids;</text> </paragraph> <paragraph num="(5)"> <text>Testing of hearing aids;</text> </paragraph> <paragraph num="(6)"> <text>Maintenance and basic repair of hearing aids;</text> </paragraph> <paragraph num="(7)"> <text>Taking of ear mold impressions; and</text> </paragraph> <paragraph num="(8)"> <text>Other techniques and procedures that may be required to fit hearing aids.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nothing in the examination shall imply that the applicant shall possess the degree of medical competence normally expected of physicians.</text> </paragraph> <paragraph num="E."> <text>Passing Score.</text> <paragraph num="(1)"> <text>Written Examination.</text> <paragraph num="(a)"> <text>The Board shall determine the passing score for the written examination.</text> </paragraph> <paragraph num="(b)"> <text>If a candidate does not earn a passing score on the written examination, the candidate shall have to retake the entire written examination.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Practical Examination. An applicant shall obtain a score of at least 80 percent on the practical examination.</text> </paragraph> <paragraph num="(3)"> <text>If the licensee's limited license has not expired and the licensee passed the examination within the past 2 years, the Board shall accept prior passage of the written examination, the practical examination, or both.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Practice of Limited Licensee."> <paragraph num="A."> <text>The holder of a limited license shall be familiar with and shall avoid committing any of the acts regarded as unethical practices set forth in COMAR 10.41.02.</text> </paragraph> <paragraph num="B."> <text>On obtaining a limited license, the holder of a limited license shall engage in the practice of fitting and dispensing hearing aids for 20 consecutive days under the direct and continuous supervision of a licensee. The licensee shall provide direct supervision subsequently for a minimum of 40 hours per month for at least 6 months.</text> </paragraph> <paragraph num="C."> <text>The supervising hearing aid dispenser shall be immediately available and physically on-site.</text> </paragraph> <paragraph num="D."> <text>Supervision shall include training in those areas of the examination outlined in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="E."> <text>The limited licensee shall maintain documentation of supervision and training and shall submit the documentation to the Board upon request.</text> </paragraph> <paragraph num="F."> <text>A licensee who supervises an applicant for a limited license shall assume full responsibility for the ethical conduct of the limited licensee.</text> </paragraph> <paragraph num="G."> <text>Termination of Supervision.</text> <paragraph num="(1)"> <text>The supervising licensee may terminate the supervisory responsibility by discharging the limited licensee and returning the license to the Board, together with a letter explaining fully the circumstances under which the limited licensee was separated from the employment of the supervisor.</text> </paragraph> <paragraph num="(2)"> <text>If the limited license cannot be returned, the supervising licensee shall include a full explanation in the letter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A limited license expires on the first anniversary of its effective date.</text> </paragraph> <paragraph num="I."> <text>The Board may renew the limited license once for an additional 1-year term if the limited licensee:</text> <paragraph num="(1)"> <text>Takes but fails the examination; or</text> </paragraph> <paragraph num="(2)"> <text>Does not take the examination for a reason acceptable to the Board.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If a limited licensee fails to receive a full license within 2 years after the initial limited license was issued, the individual shall wait a minimum of 1 year before the individual may apply for another limited license.</text> </paragraph> <paragraph num="K."> <text>The supervisor of a limited licensee:</text> <paragraph num="(1)"> <text>Shall hold a valid license issued by the Maryland Board;</text> </paragraph> <paragraph num="(2)"> <text>Shall conduct all required direct and continuous supervision as defined in §B of this regulation, at a Maryland hearing aid dispensing practice only;</text> </paragraph> <paragraph num="(3)"> <text>Shall be actively involved in the dispensing of hearing aids;</text> </paragraph> <paragraph num="(4)"> <text>Shall have been in practice for a minimum of 2 years after passing the Board examination;</text> </paragraph> <paragraph num="(5)"> <text>Shall supervise not more than three limited licensees at one time; and</text> </paragraph> <paragraph num="(6)"> <text>May not have been formally disciplined by the Board within the previous 5 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Repealed." /> <regulation prefix="Regulation" num=".08" heading="Testing Procedures."> <paragraph num="A."> <text>The licensee or holder of a limited license who is engaged in the fitting and dispensing of hearing aids shall use appropriate testing procedures for a hearing aid fitting.</text> </paragraph> <paragraph num="B."> <text>The licensee or holder of a limited license shall perform the following minimum testing procedures on each client evaluated prior to the fitting of a hearing aid or hearing aids:</text> <paragraph num="(1)"> <text>Pure tone air conduction thresholds at 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 6,000 Hz, and 8,000 Hz, including masking as needed, if the threshold between the ears differs, at any frequency, by:</text> <paragraph num="(a)"> <text>40 decibels when using supra aural headphones;</text> </paragraph> <paragraph num="(b)"> <text>60 decibels when using insert earphones, properly inserted; or</text> </paragraph> <paragraph num="(c)"> <text>Inter-octave frequencies that shall be tested if there is a difference of 15dB or greater between octave frequencies as specified under §B(1)(a) and (b) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pure tone bone conduction thresholds, including masking as needed, at 500 Hz, 1000 Hz, 2000 Hz, and 4000Hz; and</text> </paragraph> <paragraph num="(3)"> <text>Word recognition scores obtained using recorded word lists or monitored live voice. Presentation level shall be at least 40dB above speech recognition threshold or at least 5dB above the threshold at 2000Hz, or both, if within level of tolerance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The use of speech stimuli, such as speech in noise testing, is recommended before and after the fitting of the hearing aid.</text> </paragraph> <paragraph num="D."> <text>The use of probe microphone measurements are recommended to verify the audibility of speech at 50dB, 65dB, and 80dB input levels as well as MPO measurements to avoid damage to the peripheral auditory system and check comfort of the hearing aid users.</text> </paragraph> <paragraph num="E."> <text>The hearing aid dispenser shall:</text> <paragraph num="(1)"> <text>Maintain and retain all test results as part of a client’s record. Part or all of the tests may be performed by an otologist or clinical audiologist, but the test may not be more than 6 months old for the use of a hearing device fitting; and</text> </paragraph> <paragraph num="(2)"> <text>Provide to the client a copy of all:</text> <paragraph num="(a)"> <text>Test results;</text> </paragraph> <paragraph num="(b)"> <text>Recommendations; and</text> </paragraph> <paragraph num="(c)"> <text>Referrals.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>During the 2-year renewal, a hearing aid dispenser shall furnish evidence that each audiometer in use has been calibrated within the previous 12-month period.</text> </paragraph> <paragraph num="G."> <text>Before fitting or selling a hearing aid to a potential client, the licensee shall refer the client to a physician, preferably one specializing in the diseases of the ear, if the licensee determines that the client has any of the following conditions:</text> <paragraph num="(1)"> <text>Visible, congenital, or traumatic deformity of the ear;</text> </paragraph> <paragraph num="(2)"> <text>Acute drainage from the ear within the previous 90 days;</text> </paragraph> <paragraph num="(3)"> <text>Sudden or rapidly progressive hearing loss within the previous 90 days;</text> </paragraph> <paragraph num="(4)"> <text>Acute or chronic dizziness;</text> </paragraph> <paragraph num="(5)"> <text>Pain, discomfort, foreign body/material, or active drainage in the ear;</text> </paragraph> <paragraph num="(6)"> <text>Air-bone gap in excess of 15 decibels on more than one frequency;</text> </paragraph> <paragraph num="(7)"> <text>Evidence of congenital or traumatic deformity of the ear, not previously evaluated;</text> </paragraph> <paragraph num="(8)"> <text>Unilateral or asymmetrical hearing loss with a difference of greater than 15dB pure tone average between ears, or asymmetry greater than 15dB at 2 or more frequencies; or</text> </paragraph> <paragraph num="(9)"> <text>Visible evidence of cerumen (ear wax) accumulation or a foreign body in the ear canal.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Place of Business."> <paragraph num="A."> <text>A licensee shall display the license conspicuously in the office or place of employment of the licensee.</text> </paragraph> <paragraph num="B."> <text>A licensee shall notify the Board in writing of:</text> <paragraph num="(1)"> <text>The address of each place where the licensee provides hearing aid services; and</text> </paragraph> <paragraph num="(2)"> <text>A change of address within 30 days after the change.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a licensee has more than one place of business, the licensee shall specify on each notice required under this regulation the place to which the Board should mail its notices and other correspondence to the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Disclosure."> <paragraph num="A."> <text>A licensee shall deliver to an individual supplied with a hearing aid, a receipt containing:</text> <paragraph num="(1)"> <text>The licensee's signature;</text> </paragraph> <paragraph num="(2)"> <text>The address of the licensee's regular place of practice;</text> </paragraph> <paragraph num="(3)"> <text>The licensee's license number;</text> </paragraph> <paragraph num="(4)"> <text>Specifications as to the amount charged;</text> </paragraph> <paragraph num="(5)"> <text>Other terms of the sale, stated clearly; and</text> </paragraph> <paragraph num="(6)"> <text>The manufacturer, model, and serial number of the hearing aid provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a hearing aid is not new, the licensee shall ensure that the receipt is clearly marked “used” or “reconditioned” and state the terms of any guarantee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Continuing Education Requirements."> <paragraph num="A."> <text>A licensee applying for renewal of a license shall have successfully completed, within the 2-year licensing period, a total of 30 hours of Board-approved continuing education programs. Of the 30 hours, the licensee shall complete:</text> <paragraph num="(1)"> <text>26 or more hours of instruction directly relating to the practice of fitting hearing aids, including the:</text> <paragraph num="(a)"> <text>Science of hearing and hearing disorders;</text> </paragraph> <paragraph num="(b)"> <text>Structure and function of hearing aids; and</text> </paragraph> <paragraph num="(c)"> <text>Psychology of the hearing impaired;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Not more than:</text> <paragraph num="(a)"> <text>4 hours of instruction directly relating to managerial aspects of the practice of fitting hearing aids, including:</text> <paragraph num="(i)"> <text>Good business principles; and</text> </paragraph> <paragraph num="(ii)"> <text>Customer management principles; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>5 hours of continuing education credit in a single continuing education cycle by attending regularly scheduled Board meetings where 1 hour of an open session at a Board meeting equals 1 hour of continuing education credit;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A minimum of 1 CEU in the area of cultural competency; and</text> </paragraph> <paragraph num="(4)"> <text>A minimum of 1 CEU in the area of ethics.</text> </paragraph> </paragraph> <paragraph num="B."> <text>It is recommended that a licensee applying for the renewal of a license successfully complete, within the 2-year licensing period as a part of required 30 hours of Board-approved continuing education programs a minimum of 2 CEUs in the area of supervision.</text> </paragraph> <paragraph num="C."> <text>A licensee who fails to complete the continuing education requirements within the time frame specified under COMAR 10.41.03.06 may be subject to:</text> <paragraph num="(1)"> <text>Informal or formal discipline for failure to meet the requirements; and</text> </paragraph> <paragraph num="(2)"> <text>A monetary fine not to exceed $250.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Pro Bono Work.</text> <paragraph num="(1)"> <text>CEUs may be earned for pro bono work at the rate of 1 Maryland CEU for every 8 hours of Board-approved CEU activity up to a maximum of 3 CEU credits in any single 2-year period.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall obtain approval from the Board for all pro bono work.</text> </paragraph> <paragraph num="(3)"> <text>The licensee shall provide the Board a written description of the proposed work not later than 60 days before beginning pro bono work. The description shall include:</text> <paragraph num="(a)"> <text>The place where the pro bono work will take place;</text> </paragraph> <paragraph num="(b)"> <text>The type of work to be performed;</text> </paragraph> <paragraph num="(c)"> <text>The number of hours of actual work to be performed for which the licensee desires CEU credit;</text> </paragraph> <paragraph num="(d)"> <text>A description of how the work will enhance the licensee's ongoing education; and</text> </paragraph> <paragraph num="(e)"> <text>A statement guaranteeing that the licensee will not receive any financial gain from the work provided.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The licensee shall submit a written statement to the Board from the facility verifying the number of pro bono work hours completed.</text> </paragraph> <paragraph num="(5)"> <text>CEU credit may not be granted for work that did not receive prior approval from the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>First-Time Renewal of License.</text> <paragraph num="(1)"> <text>Continuing education units shall be prorated for:</text> <paragraph num="(a)"> <text>Licensees holding a full license for at least 6 months but less than 2 years during the renewal cycle;</text> </paragraph> <paragraph num="(b)"> <text>Newly licensed individuals; and</text> </paragraph> <paragraph num="(c)"> <text>Individuals seeking reinstatement.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall waive all continuing education requirements for a licensee obtaining full licensure within the last 6 months of the renewal cycle.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Miscellaneous.</text> <paragraph num="(1)"> <text>Continuing education units may not be carried over from one renewal period to the next renewal period.</text> </paragraph> <paragraph num="(2)"> <text>If the licensee presents evidence to the Board that failure to obtain the required continuing education units was due to circumstances beyond the licensee’s control, the Board may grant an extension of time to obtain the required continuing education units.</text> </paragraph> <paragraph num="(3)"> <text>If the Board grants an extension of time as provided for in §E(2) of this regulation, the Board may require the licensee to obtain, as additional continuing education, not more than twice the number of missing credits in order to renew the license.</text> </paragraph> <paragraph num="(4)"> <text>The Board may reduce or waive the continuing education requirements for an individual under extenuating circumstances as determined by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Renewal of Licensure."> <paragraph num="A."> <text>A licensee shall undergo a new criminal records history check as set forth in Health Occupations Article, §2-303.1, Annotated Code of Maryland, every three renewal cycles or every 6 years.</text> </paragraph> <paragraph num="B."> <text>A licensee who has failed to renew a license to practice in this State by March 3 of the year in which the license is due to be renewed is prohibited from practicing in this State.</text> </paragraph> <paragraph num="C."> <text>If the Board determines that a licensee has practiced in this State after the license has expired, the Board may:</text> <paragraph num="(1)"> <text>Order the licensee to immediately cease and desist practice in this State until the license has been reinstated by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Take action as follows against a licensee for unprofessional conduct if it determines that the licensee practiced in this State after the license has expired:</text> <paragraph num="(a)"> <text>Issue a nonpublic consent agreement in which the licensee agrees to make an anonymous donation of $250 to a charitable institution and to perform 40 hours of Board-approved pro bono services;</text> </paragraph> <paragraph num="(b)"> <text>Provide the licensee with a settlement conference; or</text> </paragraph> <paragraph num="(c)"> <text>Charge the licensee with unprofessional conduct as provided in Health Occupations Article, §2-314(10), Annotated Code of Maryland, for practicing without a license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Licensee Responsibilities."> <paragraph num="A."> <text>A licensee shall notify the Board in writing of a change of:</text> <paragraph num="(1)"> <text>Mailing address within 30 days after the change;</text> </paragraph> <paragraph num="(2)"> <text>Name within 30 days after the change; or</text> </paragraph> <paragraph num="(3)"> <text>Email address within 30 days after the change if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee who fails to comply with requirements of this regulation may be subject to disciplinary action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Sale of Hearing Aid Software Guidelines."> <paragraph num="A."> <text>To the extent not inconsistent with federal law, a licensee shall, before the consummation of a sale of a hearing aid that uses proprietary programming software or locked, nonproprietary programming software, provide the purchaser with a written notice that:</text> <paragraph num="(1)"> <text>States, “The hearing aid being purchased uses proprietary or locked programming software and can only be serviced or programmed at specific facilities or locations.”;</text> </paragraph> <paragraph num="(2)"> <text>Shall be signed by the purchaser before the sale; and</text> </paragraph> <paragraph num="(3)"> <text>Includes a copy that is kept and maintained by the licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To the extent not inconsistent with federal law, a licensee shall, upon the consummation of a sale of a hearing aid, deliver to the purchaser a written receipt, signed by or on behalf of the licensee, containing all of the following:</text> <paragraph num="(1)"> <text>The date of consummation of the sale;</text> </paragraph> <paragraph num="(2)"> <text>Specifications as to the make, serial number, and model number of the hearing aid or aids sold;</text> </paragraph> <paragraph num="(3)"> <text>The address of the principal place of business of the licensee, and the address and office hours at which the licensee shall be available for fitting or post-fitting adjustments and servicing of the hearing aid or aids sold;</text> </paragraph> <paragraph num="(4)"> <text>A statement to the effect that the aid or aids delivered to the purchaser are used or reconditioned, as the case may be, if that is the fact;</text> </paragraph> <paragraph num="(5)"> <text>The number of the licensee’s license and the name and license number of any other hearing aid dispenser, temporary licensee, or trainee licensee, who provided any recommendation or consultation regarding the purchase of the hearing aid; and</text> </paragraph> <paragraph num="(6)"> <text>The terms of any guarantee or written warranty, as required by federal law or regulations, made to the purchaser with respect to the hearing aid or hearing aids.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-101(d), 2-205, 2-302.1, 2-304, 2-308, 2-310.1, 2-311(c), 2-311 — 2-314.8, 2-314(10) and (11), and 2-314.9, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 10, 1997 (24:3 Md. R. 188)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective March 23, 2009 (36:6 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective April 29, 2013 (40:8 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective April 29, 2013 (40:8 Md. R. 724); June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I adopted effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02J adopted effective June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K adopted effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 28, 2002 (29:21 Md. R. 1646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective October 28, 2002 (29:21 Md. R. 1646); October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I amended effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective October 13, 2003 (30:20 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective March 23, 2009 (36:6 Md. R. 492); June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective May 30, 2011 (38:11 Md. R. 671); January 7, 2013 (39:26 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D adopted effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective June 20, 2016 (43:12 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="09" heading="Civil Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the standards by which the Board may impose an administrative monetary penalty not exceeding $5,000 on an individual licensed under Health Occupations Article, Title 2, Annotated Code of Maryland, for an act or omission prohibited under Health Occupations Article, §2-314, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(2)"> <text>“Licensee” means an individual licensed by the Board to practice audiology, hearing aid dispensing, speech-language pathology, music therapy, or assists in the practice of speech-language pathology or audiology.</text> </paragraph> <paragraph num="(3)"> <text>“Violation” means an act or omission prohibited under Health Occupations Article, §2-314, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authority to Impose Administrative Monetary Penalty."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §2-315, Annotated Code of Maryland, and COMAR 10.41.04, the Board may impose an administrative monetary penalty under this chapter on a licensee who is found to have committed a violation.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a penalty under §A of this regulation:</text> <paragraph num="(1)"> <text>For each determination by the Board that there are grounds to suspend or revoke the license of a licensee or to reprimand a licensee or place a licensee on probation; and</text> </paragraph> <paragraph num="(2)"> <text>In addition to any suspension or revocation, or reprimanding the licensee or placing the licensee on probation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Factors To Be Considered in Assessment of Penalties."> <text>In determining whether to impose a penalty and the amount of the penalty, the Board shall consider the following factors:</text> <paragraph num="A."> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="B."> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="C."> <text>The extent to which the individual derived any financial benefit from the violation;</text> </paragraph> <paragraph num="D."> <text>The history of any previous violation;</text> </paragraph> <paragraph num="E."> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="F."> <text>Any mitigating factors as presented by the licensee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Payment of Penalties."> <paragraph num="A."> <text>An individual shall pay to the Board within a time set by the Board any administrative monetary penalty imposed under this chapter.</text> </paragraph> <paragraph num="B."> <text>The Board shall pay into the General Fund of the State all monies collected under this chapter.</text> </paragraph> <paragraph num="C."> <text>If an individual fails to pay, in whole or in part, any penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew the license of the individual until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205, 2-314.9, and 2-315, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 7, 1997 (24:7 Md. R. 553)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 20, 2008 (35:21 Md. R. 1824)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 26, 2016 (43:19 Md. R. 1072)</annotation> </annotations> </chapter> <chapter num="10" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter permits the Board to disclose investigative information to other agencies or other entities, or both, under certain circumstances.</text> </paragraph> <paragraph num="B."> <text>A custodian may disclose information in a certification, licensing, or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>A custodian may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law and is disclosed to a federal, state, or local regulatory authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency which regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §2-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 2002 (28:26 Md. R. 2273)</annotation> </annotations> </chapter> <chapter num="11" heading="Speech-Language Pathology Assistants and Audiology Assistants"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Audiology assistant” means an individual who:</text> <paragraph num="(a)"> <text>Meets the minimum qualifications established under:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 2, Subtitle 3A, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This chapter;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Does not work independently; and</text> </paragraph> <paragraph num="(c)"> <text>Works under the general supervision of an audiologist licensed under Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists and Music Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“Continuing education unit (CEU)” means 1 hour of attendance at a Board-approved program as described in COMAR 10.41.03.06.</text> </paragraph> <paragraph num="(4)"> <text>“Credit hour” means 1 academic credit hour of an academic course conducted by an accredited academic institution.</text> </paragraph> <paragraph num="(5)"> <text>“Delegation agreement” means an agreement between a speech-language pathology assistant or an audiology assistant and a supervising speech-language pathologist or audiologist which identifies the supervising speech-language pathologist or audiologist and the facility at which the speech-language pathology assistant or the audiology assistant will be practicing.</text> </paragraph> <paragraph num="(6)"> <text>Direct supervision</text> <paragraph num="(a)"> <text>“Direct supervision” means on-site, in-view, observation and guidance by a supervising speech-language pathologist or audiologist while on an assigned activity.</text> </paragraph> <paragraph num="(b)"> <text>“Direct supervision” includes the supervising audiologist viewing and communicating with the speech-language pathology assistant or audiology assistant via telecommunication technology to provide clinical services.</text> </paragraph> <paragraph num="(c)"> <text>“Direct supervision” does not include reviewing a recorded session at a later time.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“General supervision” means the supervision of a licensed speech-language pathology assistant or audiology assistant by a licensed speech-language pathologist or audiologist who may or may not be present when the licensed speech-language pathology assistant or audiology assistant assists in the practice of speech-language pathology or audiology.</text> </paragraph> <paragraph num="(8)"> <text>“Indirect supervision” means those activities other than direct observation and guidance conducted by a supervising speech-language pathologist or audiologist including, but not limited to:</text> <paragraph num="(a)"> <text>Review of charts and records;</text> </paragraph> <paragraph num="(b)"> <text>Attendance at meetings; or</text> </paragraph> <paragraph num="(c)"> <text>Phone contact.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Speech-language pathology assistant” means an individual who:</text> <paragraph num="(a)"> <text>Assists the supervising speech-language pathologist clinically in the implementation of treatment and other defined activities; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the minimum requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Supervising speech-language pathologist” means an individual who meets all requirements set forth in this chapter and who:</text> <paragraph num="(a)"> <text>Is licensed by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>In exempt settings, holds the Certificate of Clinical Competence (CCC) in Speech-Language Pathology from the American Speech-Language Hearing Association (ASHA).</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Supervision” means both direct and indirect supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Speech-Language Pathology Assistant License Requirements."> <paragraph num="A."> <text>The Board shall issue a speech-language pathology assistant license to an applicant who:</text> <paragraph num="(1)"> <text>Meets the following qualifications:</text> <paragraph num="(a)"> <text>Has completed the educational requirements in §C of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Has completed the clinical hours requirements in §D of this regulation;</text> </paragraph> <paragraph num="(c)"> <text>Has obtained a limited license as a speech-language pathology assistant from the Board;</text> </paragraph> <paragraph num="(d)"> <text>Has completed a period of not less than 9 months of supervised practice as specified in Regulation .03B of this chapter; and</text> </paragraph> <paragraph num="(e)"> <text>Submits a competency checklist completed by the supervising speech-language pathologist to the Board; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meets the qualifications for waiver of requirements in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after receipt of an incomplete application of the materials that are required.</text> </paragraph> <paragraph num="(2)"> <text>An application is not complete until all required material, including the application fee and supporting documentation, is received by the Board.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide the required documentation within 1 year of receipt of the initial receipt, the Board may administratively close the application.</text> </paragraph> <paragraph num="(4)"> <text>An applicant whose application is administratively closed may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Academic Curriculum Requirements.</text> <paragraph num="(1)"> <text>A speech-language pathology assistant shall demonstrate completion of one of the following requirements, unless a request for an exception based on extenuating circumstances, with documented continuing education during the previous 5 years is approved by the Board:</text> <paragraph num="(a)"> <text>An associate’s degree from an approved program for speech-language pathology assistants at an accredited institution;</text> </paragraph> <paragraph num="(b)"> <text>An associate’s degree or higher in an allied health field from an accredited institution with minimum course work that includes at least 3 credit hours in each of the following areas:</text> <paragraph num="(i)"> <text>Language acquisition and usage throughout the lifespan;</text> </paragraph> <paragraph num="(ii)"> <text>Speech disorders;</text> </paragraph> <paragraph num="(iii)"> <text>Anatomy and physiology of speech systems;</text> </paragraph> <paragraph num="(iv)"> <text>Language disorders, including pragmatics; and</text> </paragraph> <paragraph num="(v)"> <text>Phonology; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A baccalaureate degree in speech-language pathology or communication science disorders from an accredited institution.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall accept only an official transcript that demonstrates course work completed with a grade of at least a “C” taken for credit.</text> </paragraph> <paragraph num="(3)"> <text>Academic course titles which are not self-explanatory shall be substantiated through course descriptions in official school catalogs or bulletins, or by other official means.</text> </paragraph> <paragraph num="(4)"> <text>Degrees or course work, or both, received at foreign universities are acceptable only if the course work and clinical practicum hours can be demonstrated, at the applicant’s expense, to meet the requirements of this section.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Hours Requirements.</text> <paragraph num="(1)"> <text>A speech-language pathology assistant shall demonstrate at the time of application for licensure:</text> <paragraph num="(a)"> <text>Completion of at least 25 hours of clinical observation and 75 hours of clinical assisting experience in an associate’s program; or</text> </paragraph> <paragraph num="(b)"> <text>25 observation and 75 clinical practice hours as a speech-language pathology student in a bachelor’s or master’s program obtained within an educational institution or in one of the educational institution’s cooperating programs.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Alternative Method for Completion of Clinical Hours.</text> <paragraph num="(a)"> <text>If an applicant has not obtained the hours required in §D(1) of this regulation, the applicant may file with the Board a written plan for an alternative method to obtain the hours which shall include:</text> <paragraph num="(i)"> <text>A plan for the clinical observation, or clinical assisting experience, or both, designed and signed by the supervising speech-language pathologist;</text> </paragraph> <paragraph num="(ii)"> <text>Further information or revisions as requested by the Board;</text> </paragraph> <paragraph num="(iii)"> <text>An application for limited licensure; and</text> </paragraph> <paragraph num="(iv)"> <text>The fee for limited licensure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The plan for obtaining the 75 hours of clinical assistance shall include 100 percent direct supervision by the supervising speech-language pathologist of the speech-language pathologist assistant during any client contact hours.</text> </paragraph> <paragraph num="(c)"> <text>The Board shall approve the plan and issue the limited license before any clinical observation or clinical assisting experience may be obtained.</text> </paragraph> <paragraph num="(d)"> <text>The limited licensee shall then complete the hours in accordance with the Board-approved plan within 60 days.</text> </paragraph> <paragraph num="(e)"> <text>If the Board does not receive proof of successful completion of the hours by the end of 90 days, the limited assistant license is void and the speech-language pathology assistant may reapply.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Speech-Language Pathology Assistant Limited License."> <paragraph num="A."> <text>The Board shall issue a speech-language pathology assistant license to a limited licensee who:</text> <paragraph num="(1)"> <text>Has successfully completed the requirements of the limited licensure period; or</text> </paragraph> <paragraph num="(2)"> <text>Meets the qualifications for waiver of requirements in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervised Practice Requirements.</text> <paragraph num="(1)"> <text>A speech-language pathology assistant shall have a limited license from the Board before beginning supervised practice.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall issue a limited license to practice as a speech-language pathology assistant to an applicant who:</text> <paragraph num="(a)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(b)"> <text>Meets the qualifications indicated in Regulation .02A of this chapter and:</text> <paragraph num="(i)"> <text>Has completed the requirements of Regulation .02D(1) of this chapter; or</text> </paragraph> <paragraph num="(ii)"> <text>Has submitted a plan approved by the Board as provided in Regulation .02D(2) of this chapter;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Submits the completed application and fee to the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Submits a delegation agreement to the Board for each supervising speech-language pathologist.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>During the period of limited licensure, the speech-language pathology assistant shall:</text> <paragraph num="(a)"> <text>Practice only under the supervision of:</text> <paragraph num="(i)"> <text>A fully licensed speech-language pathologist; or</text> </paragraph> <paragraph num="(ii)"> <text>An individual who holds a Certificate of Clinical Competence in speech-language pathology from the American Speech-Language-Hearing Association;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Demonstrate completion, within the first 60 days, under direct supervision as documented by the supervising speech-language pathologist of:</text> <paragraph num="(i)"> <text>At least 25 hours of clinical observation earned during the educational training or on the job, or both; and</text> </paragraph> <paragraph num="(ii)"> <text>A cumulative total of 75 hours of clinical assistance earned during the educational training or on the job, or both; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Practice a minimum of 9 months under a limited license.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The limited license shall expire 12 months after its effective date.</text> </paragraph> <paragraph num="(5)"> <text>The supervising speech-language pathologist shall ensure that the speech-language pathology assistant demonstrates successful completion of the Board’s competency skills checklist.</text> </paragraph> <paragraph num="(6)"> <text>The speech-language pathology assistant shall submit the completed competency skills checklist to the Board at least 60 days before the limited license expiration date.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Audiology Assistant License Requirements."> <paragraph num="A."> <text>The Board shall issue an audiology assistant license to an applicant who:</text> <paragraph num="(1)"> <text>Meets the following qualifications:</text> <paragraph num="(a)"> <text>Holds a high school diploma or equivalent degree such as a GED from an accredited institution;</text> </paragraph> <paragraph num="(b)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(c)"> <text>Demonstrates oral competency;</text> </paragraph> <paragraph num="(d)"> <text>Submits a criminal history records check in accordance with Health Occupations Article, §2-303.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(e)"> <text>Submits an application to the Board on the form that the Board requires; and</text> </paragraph> <paragraph num="(f)"> <text>Pays the application fee set by the Board; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Meets the qualifications for waiver of requirements in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after receipt of an incomplete application of the materials that are required.</text> </paragraph> <paragraph num="(2)"> <text>An application is not complete until all required material, including the application fee and supporting documentation, is received by the Board.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide the required documentation within 1 year of receipt of the initial receipt, the Board may administratively close the application.</text> </paragraph> <paragraph num="(4)"> <text>An applicant whose application is administratively closed may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Academic Curriculum Requirement. An audiology assistant shall provide proof of completion of a high school diploma or higher.</text> </paragraph> <paragraph num="D."> <text>An audiology assistant:</text> <paragraph num="(1)"> <text>May not work independently; and</text> </paragraph> <paragraph num="(2)"> <text>Works under the general supervision of a licensed audiologist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Waiver of Requirements."> <paragraph num="A."> <text>The Board may waive the qualifications required for a license to practice as a speech-language pathology assistant or an audiology assistant under this chapter for an individual who:</text> <paragraph num="(1)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Pays the application fee required by the Board under COMAR 10.41.01;</text> </paragraph> <paragraph num="(3)"> <text>Has been working as:</text> <paragraph num="(a)"> <text>A speech-language pathology assistant prior to October 1, 2007; or</text> </paragraph> <paragraph num="(b)"> <text>An audiology assistant prior to October 1, 2022;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has completed the educational requirements in Regulations .02C and .04C of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Possesses sufficient qualifications which have been documented by a supervising speech-language pathologist, through completion of the speech-language pathology assistant competency skills checklist; and</text> </paragraph> <paragraph num="(6)"> <text>Completes a delegation agreement for each supervising speech-language pathologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may waive any of the qualifications required for a license to practice as a speech-language pathology assistant or an audiology assistant under this chapter for an individual who:</text> <paragraph num="(1)"> <text>Holds a valid certification as a speech-language pathology assistant or an audiology assistant from the American Speech-Language-Hearing Association;</text> </paragraph> <paragraph num="(2)"> <text>Holds a valid license, certification, or registration as a speech language pathology assistant or an audiology assistant in another state whose qualifications for a speech-language pathology assistant or an audiology assistant are equivalent to the qualifications for a speech-language pathology assistant or an audiology assistant in this State; or</text> </paragraph> <paragraph num="(3)"> <text>Qualifies under the waiver of requirements provided in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Speech-Language Pathology Assistant Scope of Practice."> <paragraph num="A."> <text>A speech-language pathology assistant may provide only services which assist the direct services provided by a supervising speech-language pathologist, and not services which are alternatives to direct services.</text> </paragraph> <paragraph num="B."> <text>Activities within the scope of practice of a speech-language pathology assistant or an audiology assistant shall include the following:</text> <paragraph num="(1)"> <text>Engaging only in those duties planned, designed, and supervised by a supervising speech-language pathologist or audiologist;</text> </paragraph> <paragraph num="(2)"> <text>Following treatment plans or protocols developed by the supervising speech-language pathologist or audiologist who maintains professional responsibility for the plans of care;</text> </paragraph> <paragraph num="(3)"> <text>Adhering at all times to the code of ethics of the Board;</text> </paragraph> <paragraph num="(4)"> <text>Identifying the licensee as a speech-language pathology assistant or an audiology assistant to consumers and co-professionals;</text> </paragraph> <paragraph num="(5)"> <text>Following specified screening protocols developed by the supervising speech-language pathologist or audiologist when conducting speech-language or audiology screenings; and</text> </paragraph> <paragraph num="(6)"> <text>Reporting documented evidence of treatment and non-interpretive data regarding the client’s performance to the supervising speech-language pathologist or audiologist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Activities within the scope of practice of a speech-language pathology assistant or an audiology assistant may include the following:</text> <paragraph num="(1)"> <text>Performing preparation of materials;</text> </paragraph> <paragraph num="(2)"> <text>Scheduling activities;</text> </paragraph> <paragraph num="(3)"> <text>Preparing charts, records, graphs, and other clerical duties;</text> </paragraph> <paragraph num="(4)"> <text>Performing checks and maintenance of equipment;</text> </paragraph> <paragraph num="(5)"> <text>Participating with the supervising speech-language pathologist or audiologist in research projects, in-service training, and public relations programs;</text> </paragraph> <paragraph num="(6)"> <text>Assisting the speech-language pathologists or audiologists during patient assessments; and</text> </paragraph> <paragraph num="(7)"> <text>Assisting the audiologists with basic diagnostic tests, such as audiometry and tympanometry.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Activities not within the scope of practice of a speech-language pathology assistant or an audiology assistant include:</text> <paragraph num="(1)"> <text>Performing or interpreting the results of diagnostic evaluations;</text> </paragraph> <paragraph num="(2)"> <text>Participating in parent conferences, case conferences, or interdisciplinary team meetings without the presence of the supervising speech-language pathologist or audiologist, or other licensed speech-language pathologist or audiologist designated by the supervising speech-language pathologist or audiologist;</text> </paragraph> <paragraph num="(3)"> <text>Providing client or family counseling;</text> </paragraph> <paragraph num="(4)"> <text>Selecting clients for services;</text> </paragraph> <paragraph num="(5)"> <text>Discharging a client from services;</text> </paragraph> <paragraph num="(6)"> <text>Making referral recommendations;</text> </paragraph> <paragraph num="(7)"> <text>Disclosing clinical or confidential information either orally or in writing to anyone other than the supervising speech-language pathologist or audiologist; or</text> </paragraph> <paragraph num="(8)"> <text>Providing specialized treatment that requires advanced knowledge and training.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Audiology assistants may not perform any task:</text> <paragraph num="(1)"> <text>Without the express knowledge and approval of the supervising audiologist; and</text> </paragraph> <paragraph num="(2)"> <text>That may be prohibited by state or federal law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Supervisor Responsibilities."> <paragraph num="A."> <text>A supervising speech-language pathologist or audiologist is responsible for the direction of all client services provided by a speech-language pathology assistant or an audiology assistant.</text> </paragraph> <paragraph num="B."> <text>A licensed full-time (35 hours or more a week) speech-language pathologist or audiologist may not supervise more than the equivalent of two full-time (35 hours or more a week) speech-language pathology assistants or audiology assistants.</text> </paragraph> <paragraph num="C."> <text>A licensed part-time (less than 35 hours a week) speech-language pathologist or audiologist may not supervise more than the equivalent of one full-time (35 hours a week) speech-language pathology assistant or audiology assistant.</text> </paragraph> <paragraph num="D."> <text>A supervising speech-language pathologist or audiologist shall:</text> <paragraph num="(1)"> <text>Have a minimum of 3 years work experience (2 years since receipt of full license or ASHA-CCC) as a speech-language pathologist or audiologist;</text> </paragraph> <paragraph num="(2)"> <text>Maintain on-going contact with all clients seen by a speech-language pathology assistant or an audiology assistant by participating in:</text> <paragraph num="(a)"> <text>Not less than one session every 2 weeks of in-person contact per client if the client is being seen three times per week or more; or</text> </paragraph> <paragraph num="(b)"> <text>Not less than one session per month of in-person contact per client if the client is being seen two times per week or less;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide supervision of the speech-language pathology assistant or the audiology assistant that is a combination of direct on-site activities and indirect activities;</text> </paragraph> <paragraph num="(4)"> <text>Be on-site to supervise the speech-language pathology assistant during the first 2 hours of treatment for each client and then at least 1 direct hour of supervision during each subsequent month;</text> </paragraph> <paragraph num="(5)"> <text>Provide general supervision to the audiology assistant and continuous availability by phone or telehealth technologies;</text> </paragraph> <paragraph num="(6)"> <text>Conduct and maintain performance evaluations of the speech language pathology assistant or the audiology assistant within the first 3 months, and at least annually thereafter, that are cosigned by both the supervising speech-language pathologist or audiologist and the speech-language pathology assistant or the audiology assistant;</text> </paragraph> <paragraph num="(7)"> <text>Provide a copy of the signed performance evaluation to the speech-language pathology assistant or the audiology assistant;</text> </paragraph> <paragraph num="(8)"> <text>Maintain documentation of client contact and supervisory activities of the speech-language pathology assistant or the audiology assistant; and</text> </paragraph> <paragraph num="(9)"> <text>Have the authority to combine in-person client contact and on-site supervision of the speech-language pathology assistant or the audiology assistant when appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Licensee Responsibilities."> <paragraph num="A."> <text>A licensee shall notify the Board in writing of a change of:</text> <paragraph num="(1)"> <text>Mailing address within 30 days after the change;</text> </paragraph> <paragraph num="(2)"> <text>Name within 30 days after the change; or</text> </paragraph> <paragraph num="(3)"> <text>Email address within 30 days after the change if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee who fails to comply with the requirements of this regulation may be subject to disciplinary action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="License Renewal."> <paragraph num="A."> <text>A speech-language pathology assistant or an audiology assistant license expires on the date set by the Board, unless it is renewed for an additional term as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>A license may not be renewed for a term longer than 2 years.</text> </paragraph> <paragraph num="C."> <text>At least 1 month before the license expires, the Board shall notify the speech-language pathology assistant or the audiology assistant of the date the license expires and the procedures for renewing the license.</text> </paragraph> <paragraph num="D."> <text>The speech-language pathology assistant or the audiology assistant is responsible for renewing licensure.</text> </paragraph> <paragraph num="E."> <text>The speech-language pathology assistant or the audiology assistant may apply to renew the license for another term if the speech-language pathology assistant or the audiology assistant:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with any continuing education requirements under Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>A delegation agreement for each supervising speech-language pathologist or audiologist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A speech-language pathology assistant or an audiology assistant shall undergo a new criminal records history check as set forth in Health Occupations Article, §2-303.1, Annotated Code of Maryland, every three renewal cycles or every 6 years.</text> </paragraph> <paragraph num="G."> <text>A licensee who has failed to renew a license to practice in this State by June 30 of the year in which the license is due to be renewed is prohibited from practicing in this State.</text> </paragraph> <paragraph num="H."> <text>If the Board determines that a licensee has practiced in this State after the license has expired, the Board may:</text> <paragraph num="(1)"> <text>Order the licensee to immediately cease and desist practice in this State until the license has been reinstated by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Take action as follows against a licensee for unprofessional conduct if it determines that the licensee practiced in this State after the license has expired:</text> <paragraph num="(a)"> <text>Issue a nonpublic consent agreement in which the licensee agrees to make an anonymous donation of $100 to a charitable institution and to perform 40 hours of Board-approved pro bono services;</text> </paragraph> <paragraph num="(b)"> <text>Provide the licensee with a settlement conference; or</text> </paragraph> <paragraph num="(c)"> <text>Charge the licensee with unprofessional conduct as provided in Health Occupations Article, §2314(10), Annotated Code of Maryland, for practicing without a license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Continuing Education Requirements."> <paragraph num="A."> <text>A speech-language pathology assistant or an audiology assistant shall obtain CEUs as a means of staying current in the field.</text> </paragraph> <paragraph num="B."> <text>The speech-language pathology assistant or the audiology assistant shall earn a minimum of ten CEUs as a condition of renewal as follows:</text> <paragraph num="(1)"> <text>Five CEUs in the area of clinical practice; and</text> </paragraph> <paragraph num="(2)"> <text>Five CEUs in work-related areas that may include the recommended completion of:</text> <paragraph num="(a)"> <text>A minimum of 1 CEU in the area of cultural competency;</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 1 CEU in the area of ethics; and</text> </paragraph> <paragraph num="(c)"> <text>Related training that does not include annual training requirements for:</text> <paragraph num="(i)"> <text>Job orientation;</text> </paragraph> <paragraph num="(ii)"> <text>Job maintenance; or</text> </paragraph> <paragraph num="(iii)"> <text>Other general information related to health care.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The speech-language pathology assistant or the audiology assistant shall retain records documenting completion of CEUs.</text> </paragraph> <paragraph num="D."> <text>At the time of license renewal, the Board shall audit 25 percent of the speech-language pathology assistants or the audiology assistants for compliance with the continuing education requirement.</text> </paragraph> <paragraph num="E."> <text>If the speech-language pathology assistant or the audiology assistant is audited by the Board, the speech-language pathology assistant or the audiology assistant shall submit to the Board the following:</text> <paragraph num="(1)"> <text>A copy of the most recent performance evaluation;</text> </paragraph> <paragraph num="(2)"> <text>An application for license renewal; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of earned CEUs completed within the 2 years immediately preceding the license expiration date.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205, 2-308, 2-311(c), 2-312(b), 2-314(10) and (11), and 2-319, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 1, 2002 (29:6 Md. R. 567)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 20, 2016 (43:12 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08F, G adopted effective June 8, 2015 (42:11 Md. R. 725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E amended as an emergency provision effective January 11, 2008 (35:3 Md. R. 286); amended permanently effective May 19, 2008 (35:10 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective June 20, 2016 (43:12 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="12" heading="Supervision of Students"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures and matters for licensed audiologists and speech-language pathologists supervising students enrolled in a graduate program for audiology or speech-language pathology.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Direct supervision” means on-site and personal oversight by an individual licensed under Health Occupations Article, Title 2, Annotated Code of Maryland, who assumes responsibility for another individual's conduct, whether it is consistent or fails to be consistent with the professional standards and provisions set forth in Health Occupations Article, Title 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“On-site” means present and working within the specific facility where the supervised student is evaluating the patient.</text> </paragraph> <paragraph num="(3)"> <text>“Supervisor” means the licensed individual who is employed by the facility and works on site.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Supervision."> <paragraph num="A."> <text>The supervisor shall provide direct on-site supervision of the student at all times.</text> </paragraph> <paragraph num="B."> <text>The supervisor is personally responsible for each patient the student evaluates and treats.</text> </paragraph> <paragraph num="C."> <text>Signing of Patient Reports.</text> <paragraph num="(1)"> <text>Both supervisor and student shall sign reports with their full name and credentials.</text> </paragraph> <paragraph num="(2)"> <text>A student may sign with the highest degree earned.</text> </paragraph> <paragraph num="(3)"> <text>A student may not sign with credentials for a degree they are currently pursuing.</text> </paragraph> <paragraph num="(4)"> <text>The title or designation of “student” shall be placed after the student's name in the report statement.</text> </paragraph> <paragraph num="(5)"> <text>The supervisor shall sign all electronic records that only accept one signature.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisor may not supervise more than the equivalent of two full-time students per day in off-site placements from a university.</text> </paragraph> <paragraph num="E."> <text>A licensed audiologist or speech-language pathologist with clinical experience and credentials that meet the standards of the individual university program shall provide clinical supervision and mentoring.</text> </paragraph> <paragraph num="F."> <text>The licensed audiologist or speech-language pathologist acting as a supervisor shall have 3 years post-degree clinical experience, including clinical fellowship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Exceptions."> <paragraph num="A."> <text>An audiology student who is enrolled full-time as a 4th-year doctoral student at a university and has completed 375 clinical training hours with 100 percent direct on-site supervision may utilize the following schedule as a minimum for supervision:</text> <paragraph num="(1)"> <text>For 3 months or the first 1/3 of the 4th year of clinical work, whichever is longer — 90 percent on-site supervision;</text> </paragraph> <paragraph num="(2)"> <text>For 3 months or the second 1/3 of the 4th year of clinical work, whichever is longer — 75 percent on-site supervision; and</text> </paragraph> <paragraph num="(3)"> <text>For 3 months or the last 1/3 of the 4th year of clinical work, whichever is longer — 50 percent on-site supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisor shall be available either on site or by telephone for consultation at all times.</text> </paragraph> <paragraph num="C."> <text>An audiology student who is enrolled full-time as a fourth year doctoral student at a university and holds a hearing aid dispenser license shall follow the requirements of §A of this regulation while working toward the degree.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§2-205 and 2-302, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 20, 2008 (35:21 Md. R. 1824)</annotation> </annotations> </chapter> <chapter num="13" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for sanctions and monetary penalties not exceeding $5,000 against any individual in the State who holds a license issued by the Board if, after a hearing, the Board or the Maryland Office of Administrative Hearings finds that there are grounds under Health Occupations Article, §2-314, Annotated Code of Maryland, to impose a sanction or monetary penalty.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Examiners for Audiologists, Hearing Aid Dispensers, Speech-Language Pathologists, and Music Therapists.</text> </paragraph> <paragraph num="(2)"> <text>“Conditions” means requirements in a public order that a licensee is required to satisfy.</text> </paragraph> <paragraph num="(3)"> <text>“License” means a license issued by the Board to:</text> <paragraph num="(a)"> <text>Practice audiology;</text> </paragraph> <paragraph num="(b)"> <text>Practice hearing aid dispensing;</text> </paragraph> <paragraph num="(c)"> <text>Practice speech-language pathology;</text> </paragraph> <paragraph num="(d)"> <text>Practice music therapy; or</text> </paragraph> <paragraph num="(e)"> <text>Assist in the practice of speech-language pathology or audiology.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Licensee” means an individual licensed by the Board to:</text> <paragraph num="(a)"> <text>Practice audiology;</text> </paragraph> <paragraph num="(b)"> <text>Practice hearing aid dispensing;</text> </paragraph> <paragraph num="(c)"> <text>Practice speech-language pathology;</text> </paragraph> <paragraph num="(d)"> <text>Practice music therapy; or</text> </paragraph> <paragraph num="(e)"> <text>Assist in the practice of speech-language pathology or audiology.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Penalty” means a monetary penalty.</text> </paragraph> <paragraph num="(6)"> <text>“Sanction” means a formal disciplinary action against a licensee such as a reprimand, probation, suspension, or revocation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty After a Hearing."> <text>If, after a hearing under Health Occupations Article, §2-315, Annotated Code of Maryland, the Board finds that there are grounds under Health Occupations Article, §2-314, Annotated Code of Maryland, to suspend or revoke a license, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="A."> <text>Instead of, or in addition to, suspending the license; or</text> </paragraph> <paragraph num="B."> <text>In addition to revoking the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions and Imposition of Penalties."> <paragraph num="A."> <text>Subject to the provisions of this section, the Board may impose sanctions and penalties for violations of the Maryland Audiology, Hearing Aid Dispensing, Speech-Language Pathology, and Music Therapy Act and its regulations according to the guidelines set forth in the following chart:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this chapter, the category or categories containing the highest maximum sanction and penalty shall prevail.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or a consent order with terms, sanction, and penalty agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="D."> <text>A departure from the guidelines set forth in this chapter alone is not grounds for any hearing or appeal of a Board action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction."> <paragraph num="A."> <text>Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>Mitigating factors:</text> <paragraph num="(a)"> <text>The licensee’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The licensee self-reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The licensee’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>Timely good-faith effort to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(f)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Absence of potential harm to public or adverse impact; and</text> </paragraph> <paragraph num="(i)"> <text>The licensee’s conduct was an isolated incident and not likely to recur; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Aggravating factors:</text> <paragraph num="(a)"> <text>The licensee has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The licensee was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the client or clients;</text> </paragraph> <paragraph num="(g)"> <text>The licensee lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(h)"> <text>The licensee committed the violation under the guise of treatment; and</text> </paragraph> <paragraph num="(i)"> <text>Previous attempts at rehabilitation of the licensee were unsuccessful.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The existence of one or more of these factors does not impose on the Board or an administrative law judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="C."> <text>Nothing in this regulation requires the Board or an administrative law judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of Penalty."> <paragraph num="A."> <text>A licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §2-316, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter into the State's General Fund.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 2-314, and 2-314.9, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 5, 2024 (51:15 Md. R. 708)</annotation> </annotations> </chapter> </subtitle> <subtitle num="42" heading="Board of Social Work Examiners"> <chapter num="01" heading="Regulations Governing Licensure"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>This chapter applies to individuals practicing social work in the State.</text> </paragraph> <paragraph num="B."> <text>The purpose of this chapter is to protect the public by:</text> <paragraph num="(1)"> <text>Providing minimum criteria for licensure under the law for those who seek to practice social work; and</text> </paragraph> <paragraph num="(2)"> <text>Promoting and maintaining high standards of professional activity in social work.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited” means receiving:</text> <paragraph num="(a)"> <text>Accreditation from the Council on Social Work Education;</text> </paragraph> <paragraph num="(b)"> <text>Approval of a program for an individual applicant by the Council on Social Work Education's Foreign Equivalency Determination Service that the program is equivalent to a program accredited by the Council on Social Work Education; or</text> </paragraph> <paragraph num="(c)"> <text>Approval of a program in candidacy for accreditation by the Council of Social Work Education.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Board-approved supervisor” means a licensed bachelor social worker (LBSW), licensed certified social worker (LCSW), licensed certified social worker-clinical (LCSW-C) or licensed master social worker (LMSW) approved by the Board to supervise social workers as set forth in COMAR 10.42.08.</text> </paragraph> <paragraph num="(4)"> <text>“Central repository” means the criminal justice information system central repository of the Maryland Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical course work” means clinical social work courses offered by an accredited or provisionally accredited program.</text> </paragraph> <paragraph num="(6)"> <text>Clinical Social Work.</text> <paragraph num="(a)"> <text>“Clinical social work” means the professional application of social work knowledge, skills, values, theories, and methods for the treatment and prevention of psychosocial dysfunction, disability, or impairment, including emotional, mental disorders, and substance use disorders with individuals, groups and families.</text> </paragraph> <paragraph num="(b)"> <text>“Clinical social work” includes formulating a diagnostic impression or a diagnosis based on standard diagnostic criteria.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Clinical social work experience” means:</text> <paragraph num="(a)"> <text>Completing assessments;</text> </paragraph> <paragraph num="(b)"> <text>Formulating diagnostic impressions or a diagnosis;</text> </paragraph> <paragraph num="(c)"> <text>Treating mental disorders and other conditions;</text> </paragraph> <paragraph num="(d)"> <text>Treating behavioral health disorders, including but not limited to substance use disorders, addictive disorders and other conditions; and</text> </paragraph> <paragraph num="(e)"> <text>Providing psychotherapy.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Criminal history records check” means the performance of both State criminal history check by the central repository and national criminal history check by the Federal Bureau of Investigation.</text> </paragraph> <paragraph num="(9)"> <text>“Criminal history records information” means information obtained:</text> <paragraph num="(a)"> <text>From the criminal history records check regarding an applicant’s criminal arrests, charges, convictions, and the disposition of pending criminal charges; and</text> </paragraph> <paragraph num="(b)"> <text>Through the Rap Back service which allows the Board to receive notification of charges thus eliminating the need for repeated background checks on a licensee.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Documentation of clinical course work” means providing transcripts indicating the completion of clinical course work from a college or university whose bachelor’s or master’s program is accredited, in candidacy, or deemed equivalent by the Council on Social Work Education.</text> </paragraph> <paragraph num="(11)"> <text>“Licensed” means that the individual possesses a license to practice social work issued by the Board.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed in any other state” means to be licensed, registered, or certified by a government authority charged with licensing, registering, or certifying social workers.</text> </paragraph> <paragraph num="(13)"> <text>“Licensee” means an individual licensed by the Board.</text> </paragraph> <paragraph num="(14)"> <text>“Licensee in another state” means an applicant that is licensed, registered, or certified by a government authority charged with licensing, registering, or certifying social workers.</text> </paragraph> <paragraph num="(15)"> <text>“Licensure by endorsement” means that an individual holds or held a license, registration, or certification to practice social work in another state after passing, in that state, a social work licensing examination and after meeting the licensing requirements for social work practice in that state.</text> </paragraph> <paragraph num="(16)"> <text>Practice Social Work.</text> <paragraph num="(a)"> <text>“Practice social work” has the meaning stated in Health Occupations Article, §19-101(m), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>“Practice social work” includes supervising a candidate for advanced licensure and a licensee in the practice of social work, when appropriate.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Rap Back service” means a service which allows the Board to receive notifications from the Federal Bureau of Investigation on applicants and licensees who may have future criminal charges thus eliminating the need for repeated background checks on the same applicant or licensee.</text> </paragraph> <paragraph num="(18)"> <text>“Reactivation” means the process of obtaining a license less than 5 years after the Board placed the license on inactive status.</text> </paragraph> <paragraph num="(19)"> <text>“Reinstatement” means the process of obtaining a license less than 5 years after the Board placed the license on a non-renewed status.</text> </paragraph> <paragraph num="(20)"> <text>“Reissuance” means the process of obtaining a license more than 5 years after the Board placed the license on inactive or non-renewed status.</text> </paragraph> <paragraph num="(21)"> <text>“Social Work” means the professional activity of helping individuals, families, groups, organizations, or communities to enhance or restore their capacity for social and psychosocial functioning.</text> </paragraph> <paragraph num="(22)"> <text>“Social worker” means an individual:</text> <paragraph num="(a)"> <text>Licensed under Health Occupations Article, Title 19, Annotated Code of Maryland, and who represents to the public by a title or description which incorporates the words “social worker”, “social work”, or a similar designation; and</text> </paragraph> <paragraph num="(b)"> <text>Who, under the title or description, offers to render, attempts to render, or renders services involving the application of principles, methods, and procedures of the profession of social work to individuals or groups.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee in which the supervisor directs, monitors, and evaluates the supervisee's social work practice while promoting development of the supervisee's knowledge, skills, and abilities to provide social work services in an ethical and competent manner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of Title."> <paragraph num="A."> <text>An individual shall be licensed by the Board in accordance with Health Occupations Article, Title 19, Annotated Code of Maryland, and this chapter, before that individual may be identified as a social worker and practice social work.</text> </paragraph> <paragraph num="B."> <text>The title “social worker” shall be used only by a licensed social worker.</text> </paragraph> <paragraph num="C."> <text>Except as otherwise provided in this chapter or provided in Health Occupations Article, §19-301(b), Annotated Code of Maryland, an individual licensed as a social worker in another state may not practice social work in this State unless licensed by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure."> <paragraph num="A."> <text>To obtain an initial license or a license for renewal, reactivation, reinstatement, or reissuance, an applicant shall complete a criminal history records check through the central repository. In accordance with Criminal Procedure Article, §§10-201—10-228, Annotated Code of Maryland, the central repository shall provide criminal history records information to the Board.</text> </paragraph> <paragraph num="B."> <text>The Board shall review the criminal history records information provided for any positive results from the criminal history records check.</text> </paragraph> <paragraph num="C."> <text>An applicant is not required to complete a criminal history records check provided the applicant completes a criminal history records check under the Rap Back service, which will automatically alert the Board of any future criminal charges.</text> </paragraph> <paragraph num="D."> <text>Bachelor Social Worker.</text> <paragraph num="(1)"> <text>The Board shall issue a bachelor social worker’s license to an applicant who has met the qualifications in Health Occupations Article, §19-302(a) and (b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>If a bachelor social worker applies for licensure in a different category, the application shall be treated as an initial application subject to the appropriate fees.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Master Social Worker.</text> <paragraph num="(1)"> <text>The Board shall issue a master social worker license to an applicant who has met the applicable qualifications in Health Occupations Article, §19-302(a) and (c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>If a master social worker applies for licensure in a different category, the application shall be treated as an initial application subject to the fees set forth in COMAR 10.42.05.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Certified Social Worker-Clinical.</text> <paragraph num="(1)"> <text>The Board shall issue a certified social worker-clinical license to an applicant who has met the requirements in Health Occupations Article, §19-302(a) and (e), Annotated Code of Maryland, with documentation of clinical course work.</text> </paragraph> <paragraph num="(2)"> <text>An applicant for a certified social worker-clinical license shall have completed 12 academic credits of clinical course work from an accredited program with a minimum of six of the 12 academic credits obtained in a Master's of Social Work program.</text> </paragraph> <paragraph num="(3)"> <text>The applicant for a certified social worker-clinical license shall have 2 years of supervised clinical social work experience as a licensed master social worker with supervised clinical social work experience of at least 3,000 hours while licensed as a master social worker which is:</text> <paragraph num="(a)"> <text>In compliance with COMAR 10.42.08;</text> </paragraph> <paragraph num="(b)"> <text>Performed in not less than 2 years and not more than 6 consecutive years; and</text> </paragraph> <paragraph num="(c)"> <text>Obtained by the candidate while performing social work activities professionally and for compensation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A candidate shall have obtained a master social worker license before applying for a certified social worker-clinical license.</text> </paragraph> <paragraph num="(5)"> <text>A candidate shall have obtained a master social worker license before beginning to obtain the 3,000 hours of supervised social work experience.</text> </paragraph> <paragraph num="(6)"> <text>A licensed master social worker shall formulate a diagnostic impression while under the supervision of a licensed certified social worker — clinical while obtaining the requisite 3,000 hours of supervised clinical social work experience.</text> </paragraph> <paragraph num="(7)"> <text>Clinical social work experience for the purpose of obtaining a certified social worker-clinical license shall be in direct service to clients and may not consist solely of:</text> <paragraph num="(a)"> <text>Telephonic clinical assessment;</text> </paragraph> <paragraph num="(b)"> <text>Triage;</text> </paragraph> <paragraph num="(c)"> <text>Continued stay reviews; and</text> </paragraph> <paragraph num="(d)"> <text>Discharge planning.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The supervisor and supervisee shall conform to the requirements in COMAR 10.42.08.</text> </paragraph> <paragraph num="(9)"> <text>Half of the supervised clinical social work experience required to obtain a certified social worker-clinical license shall consist of face-to-face client contact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Required Hours of Supervised Social Work Experience."> <paragraph num="A."> <text>A candidate with experience obtained in Maryland shall have obtained a licensed master social worker license before beginning to obtain the requisite 3,000 hours of supervised social work experience.</text> </paragraph> <paragraph num="B."> <text>A candidate with 3,000 hours of supervised social work experience from another state or jurisdiction of the United States or another country shall provide documentation that the candidate met the licensing, certification, or registration requirements in that state or jurisdiction or country while acquiring the requisite supervised social work experience.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Examinations."> <paragraph num="A."> <text>The general requirements for examination are:</text> <paragraph num="(1)"> <text>Completion of the application form;</text> </paragraph> <paragraph num="(2)"> <text>Payment of the application fee;</text> </paragraph> <paragraph num="(3)"> <text>Either:</text> <paragraph num="(a)"> <text>A receipt of an official transcript indicating completion of an accredited program from the university or school awarding the applicable social work degree attained; or</text> </paragraph> <paragraph num="(b)"> <text>For applicants who are expected to receive the applicable social work degree at the end of the semester, indication on the Board’s form of the:</text> <paragraph num="(i)"> <text>Degree that the applicant is expected to receive; and</text> </paragraph> <paragraph num="(ii)"> <text>Date that the applicant is expected to receive the degree; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>For candidates for examination for certified social worker—clinical or certified social worker licenses, documentation of social work experience and social work supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applicants may request special accommodations if disabled or if English is the applicant's second language.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Approval Notification."> <paragraph num="A."> <text>An application packet for licensure is complete when the application packet is:</text> <paragraph num="(1)"> <text>Submitted to the Board signed and dated; and</text> </paragraph> <paragraph num="(2)"> <text>Accompanied by the required non-refundable application fee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The application packet shall include:</text> <paragraph num="(1)"> <text>The completed application form answering all questions on the application;</text> </paragraph> <paragraph num="(2)"> <text>Official transcripts containing the date the degree was conferred by a program approved or deemed equivalent by the Council of Social Work Education;</text> </paragraph> <paragraph num="(3)"> <text>A passing score from the required examination administered by the Association of Social Work Boards; and</text> </paragraph> <paragraph num="(4)"> <text>Criminal history records check reports.</text> </paragraph> </paragraph> <paragraph num="C."> <text>LCSW and LCSW-C applications shall include:</text> <paragraph num="(1)"> <text>The contractual agreement form for supervision which has been signed and dated by the supervisor, supervisee and agency administrator before supervision was initiated;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of supervised social work experience; and</text> </paragraph> <paragraph num="(3)"> <text>The information and documentation required in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall notify an applicant whether the applicant has been approved to take the pertinent licensure examination within 60 days of receiving the application.</text> </paragraph> <paragraph num="E."> <text>Approval shall be valid for 2 years from the date of approval.</text> </paragraph> <paragraph num="F."> <text>After 2 years, the applicant shall:</text> <paragraph num="(1)"> <text>Reapply to take the appropriate licensure examination;</text> </paragraph> <paragraph num="(2)"> <text>Submit all of the required documentation; and</text> </paragraph> <paragraph num="(3)"> <text>Meet the current licensure requirements under this chapter.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant shall submit any additional required documentation needed to complete the application within 1 year of the Board’s receipt of the application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Examinations — Use of National Examination Boards Permitted."> <text>The Board may use a national examination board such as the Association of Social Work Boards as the Board's agent in examining applicants.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Passing Score for Examination."> <text>The passing grade for an examination is a scaled score of 75.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Reexamination."> <paragraph num="A."> <text>An applicant who fails the examination:</text> <paragraph num="(1)"> <text>May retake the examination four times within the 12-month period after a failed examination; and</text> </paragraph> <paragraph num="(2)"> <text>May not retake the examination within 3 months of failing the examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant may request and be granted or denied a waiver of the 3-month waiting period after failure of an examination upon proof of exceptional circumstances.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Licensure by Endorsement."> <paragraph num="A."> <text>An applicant who holds or held a license or registration to practice social work in another state is eligible to be licensed in Maryland at the same level of licensure as the license the applicant holds or held in the other state.</text> </paragraph> <paragraph num="B."> <text>Bachelor Social Worker.</text> <paragraph num="(1)"> <text>The Board shall issue a bachelor social worker’s license to an applicant who has met the qualifications in Health Occupations Article, §19-302(a) and (b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>If a bachelor social worker applies for licensure at a different level, the application shall be treated as an initial application subject to the fees set forth in COMAR 10.42.05.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Master Social Worker.</text> <paragraph num="(1)"> <text>The Board shall issue a master social worker license to an applicant who has met the applicable qualifications in Health Occupations Article, §19-302(a) and (c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>If a master social worker applies for licensure at a different level, the application shall be treated as an initial application subject to the fees set forth in COMAR 10.42.05.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Certified Social Worker—Clinical.</text> <paragraph num="(1)"> <text>The Board shall issue a certified social worker—clinical license to an out-of-State applicant who:</text> <paragraph num="(a)"> <text>Has more than 5 years of clinical social work practice;</text> </paragraph> <paragraph num="(b)"> <text>Holds an active clinical license comparable to the certified social worker—clinical licensure level; and</text> </paragraph> <paragraph num="(c)"> <text>Who has met the qualifications under Health Occupations Article, §19-302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall issue a certified social worker—clinical license to an out-of-State applicant who:</text> <paragraph num="(a)"> <text>Has less than 5 years of social work practice;</text> </paragraph> <paragraph num="(b)"> <text>Holds or held an active license comparable to the certified social worker—clinical licensure level; and</text> </paragraph> <paragraph num="(c)"> <text>Has met the requirements in Health Occupations Article, §19-302(a) and (e), Annotated Code of Maryland, with documentation of clinical course work.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant for a certified social worker—clinical license with less than 5 years of clinical social work experience shall have completed 12 academic credits of clinical course work from an accredited program with a minimum of six of the 12 academic credits obtained in a Master’s of Social Work program.</text> </paragraph> <paragraph num="(4)"> <text>The applicant for a certified social worker—clinical license shall have 2 years of at least 3,000 hours of supervised clinical social work experience, which shall be:</text> <paragraph num="(a)"> <text>Obtained after receiving a master’s degree in social work and as a licensed master social worker, if a licensed master social worker license was required in the jurisdiction where the supervised experience was obtained;</text> </paragraph> <paragraph num="(b)"> <text>Performed in not less than 2 years and not more than 6 consecutive years; and</text> </paragraph> <paragraph num="(c)"> <text>Obtained by the candidate while performing social work activities professionally and for compensation.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A candidate shall have obtained a master social worker license before applying for a certified social worker—clinical license.</text> </paragraph> <paragraph num="(6)"> <text>A candidate shall have obtained a master social worker license in the jurisdiction where the experience was obtained if required in that jurisdiction, before beginning to obtain the 3,000 hours of supervised social work experience.</text> </paragraph> <paragraph num="(7)"> <text>A licensed graduate social worker may render a diagnosis in the jurisdiction where the experience was obtained if in compliance with the laws in that jurisdiction, while obtaining the requisite 3,000 hours of supervised clinical social work experience.</text> </paragraph> <paragraph num="(8)"> <text>Clinical social work experience for the purpose of obtaining a certified social worker—clinical license shall be in direct service to clients and may not consist solely of:</text> <paragraph num="(a)"> <text>Telephonic clinical assessment;</text> </paragraph> <paragraph num="(b)"> <text>Triage;</text> </paragraph> <paragraph num="(c)"> <text>Continued stay reviews; and</text> </paragraph> <paragraph num="(d)"> <text>Discharge planning.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>The supervisor shall be a license social worker with a license comparable to the licensed certified social worker—clinical in Maryland.</text> </paragraph> <paragraph num="(10)"> <text>Half of the supervised clinical social work experience required to obtain a certified social worker—clinical license shall consist of face-to-face client contact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="License Without Examination."> <text>An individual who obtained licensure without examination under Ch. 853, Acts of 1975, Ch. 787, Acts of 1978, Ch. 189, Acts of 1983, or Ch. 393, Acts of 1984, is eligible to retain licensure at the level for which that individual was originally licensed if the license is renewed under the provisions of Regulation .15 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="To Practice Social Work While a License Application is Pending."> <paragraph num="A."> <text>An applicant may practice social work in Maryland without a license issued by the Board if the applicant has met the requirements established by this regulation and:</text> <paragraph num="(1)"> <text>Is:</text> <paragraph num="(a)"> <text>Licensed in any other state to practice social work;</text> </paragraph> <paragraph num="(b)"> <text>Qualified to practice social work by another country; or</text> </paragraph> <paragraph num="(c)"> <text>Qualified to practice social work by a federal entity of the United States;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has submitted a complete written application for a State social worker's license in the form prescribed by the Board and the application for a license is pending with the Board;</text> </paragraph> <paragraph num="(3)"> <text>Has received verification from the Board that a complete written application for a State social worker's license has been received by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Is 18 years old or older at the time the application is submitted to the Board;</text> </paragraph> <paragraph num="(5)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(6)"> <text>Has passed, or expects to pass within 5 months of applying for licensure, an Association of Social Work Boards examination in compliance with Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Has paid applicable fees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To practice as a bachelor social worker under this regulation, the applicant shall:</text> <paragraph num="(1)"> <text>Meet the requirements of §A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Possess a baccalaureate degree in social work from a program accredited by the Council on Social Work Education.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To practice as a master social worker under this regulation, the applicant shall:</text> <paragraph num="(1)"> <text>Meet the requirements of §A of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Possess a master's degree in social work from a program accredited by the Council on Social Work Education.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To practice as a certified social worker under this regulation, the applicant shall:</text> <paragraph num="(1)"> <text>Meet the requirements of §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Possess a master's degree in social work from a program accredited by the Council on Social Work Education;</text> </paragraph> <paragraph num="(3)"> <text>Provide documentation in a form prescribed by the Board:</text> <paragraph num="(a)"> <text>Of having completed 2 years of supervised experience of at least 3,000 hours after receiving the master's degree, with a minimum of 100 hours of periodic face-to-face supervision in the practice of social work:</text> <paragraph num="(i)"> <text>As a licensee in another state;</text> </paragraph> <paragraph num="(ii)"> <text>As a social worker who is in compliance with the laws of another country; or</text> </paragraph> <paragraph num="(iii)"> <text>As a social worker who is in compliance with a federal entity of the United States;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Indicating that the supervision complied with the supervision requirements of:</text> <paragraph num="(i)"> <text>Another state;</text> </paragraph> <paragraph num="(ii)"> <text>Another country; or</text> </paragraph> <paragraph num="(iii)"> <text>A federal entity of the United States; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Indicating that the supervisor possessed a master's degree in social work from a program accredited by the Council on Social Work Education while supervising the applicant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>To practice as a certified social worker—clinical under this regulation, the applicant shall:</text> <paragraph num="(1)"> <text>Meet the requirements of §A of this regulation and Regulation .05D(2), (7), and (9) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Possess a master's degree in social work from a program accredited by the Council on Social Work Education;</text> </paragraph> <paragraph num="(3)"> <text>Document the completion of clinical course work from a program accredited by the Council on Social Work Education;</text> </paragraph> <paragraph num="(4)"> <text>Provide documentation in a form prescribed by the Board:</text> <paragraph num="(a)"> <text>Of having completed 2 years of supervised experience of at least 3,000 hours after receiving the master's degree, with a minimum of 144 hours of periodic face-to-face supervision in the assessment, formulation of a diagnostic impression, and treatment of mental disorders and other conditions in:</text> <paragraph num="(i)"> <text>Another state;</text> </paragraph> <paragraph num="(ii)"> <text>Another country; or</text> </paragraph> <paragraph num="(iii)"> <text>A federal entity of the United States;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Indicating that the supervision complied with the supervision requirements of:</text> <paragraph num="(i)"> <text>The other state;</text> </paragraph> <paragraph num="(ii)"> <text>The other country; or</text> </paragraph> <paragraph num="(iii)"> <text>A federal entity of the United States; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Indicating that the supervisor possessed a master's degree in social work from a program accredited by the Council on Social Work Education while supervising the applicant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>An applicant may not:</text> <paragraph num="(1)"> <text>Practice social work under this regulation for more than 6 months; or</text> </paragraph> <paragraph num="(2)"> <text>Represent to the public by title or representation that the applicant is a social worker who is licensed in Maryland to practice social work.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Licenses."> <paragraph num="A."> <text>In addition to the requirements of Health Occupations Article, §19-306, Annotated Code of Maryland, the licensee shall be assigned a permanent license number that shall be in the official files of the Board.</text> </paragraph> <paragraph num="B."> <text>At the time of initial license, the Board shall issue a wall certificate which is not to be considered a license to practice social work in Maryland.</text> </paragraph> <paragraph num="C."> <text>The Board shall maintain an electronic record on its website of all licensees and the electronic record is to be considered the official license to practice social work in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Renewal of License."> <paragraph num="A."> <text>Licenses shall be renewed by October 31, every 2 years.</text> </paragraph> <paragraph num="B."> <text>For renewal purposes, a new license issued during a given year shall be treated as if it had been issued on November 1 of that same year.</text> </paragraph> <paragraph num="C."> <text>Notification of renewal shall be sent to each licensee at the last known electronic or physical address on file with the Board at least 1 month before the expiration of the license.</text> </paragraph> <paragraph num="D."> <text>Before expiration of the license, the licensee shall submit to the Board the:</text> <paragraph num="(1)"> <text>Application for renewal;</text> </paragraph> <paragraph num="(2)"> <text>Continuing education report form; and</text> </paragraph> <paragraph num="(3)"> <text>License fee, as set forth in COMAR 10.42.05.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a licensee does not file the application by the date specified in §D of this regulation, the licensee's right to practice shall terminate automatically on the expiration of the license.</text> </paragraph> <paragraph num="F."> <text>The Board may not renew a bachelor or master social worker license to a licensee who holds a baccalaureate or master’s degree from a provisionally accredited program that was denied full accreditation.</text> </paragraph> <paragraph num="G."> <text>If a licensee fails to renew a license, the license and the licensee's right to practice:</text> <paragraph num="(1)"> <text>Shall terminate; and</text> </paragraph> <paragraph num="(2)"> <text>May not be reinstated except by application for a reinstatement provided in Regulation .17 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Change of Address.</text> <paragraph num="(1)"> <text>A licensee shall notify the Board within 60 days of a change in the licensee's address or before July 1 of the licensee's renewal year, whichever occurs first, to ensure that the notice of renewal and renewed license are properly addressed.</text> </paragraph> <paragraph num="(2)"> <text>The written notification shall include:</text> <paragraph num="(a)"> <text>A statement that the licensee has changed addresses;</text> </paragraph> <paragraph num="(b)"> <text>The licensee's new address; and</text> </paragraph> <paragraph num="(c)"> <text>The licensee's signature.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Change of Name.</text> <paragraph num="(1)"> <text>A licensee shall notify the Board of a change in name within 60 days or before July 1 of the licensee’s renewal year, whichever occurs first, to insure that the renewed license documents the licensee’s legal name.</text> </paragraph> <paragraph num="(2)"> <text>The notification shall include:</text> <paragraph num="(a)"> <text>Legal documentation of the change in name;</text> </paragraph> <paragraph num="(b)"> <text>A statement of how the legal name should appear in the Board’s record including last name, first name, and middle name; and</text> </paragraph> <paragraph num="(c)"> <text>The licensee’s signature.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>If a licensee fails to receive a renewal notice, it is the responsibility of the licensee to contact the Board before October 31 of the year the license expires.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Reinstatement After Failure to Renew."> <paragraph num="A."> <text>The Board shall reinstate the license of an individual who has failed to renew a license which expired for any reason if the individual:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Complies with the continuing education requirements established by the Board for this purpose;</text> </paragraph> <paragraph num="(3)"> <text>Submits the application for reinstatement;</text> </paragraph> <paragraph num="(4)"> <text>Submits the continuing education report form with copies of the required continued education documentation as set forth in COMAR 10.42.06;</text> </paragraph> <paragraph num="(5)"> <text>Pays to the Board a reinstatement processing fee in COMAR 10.42.05; and</text> </paragraph> <paragraph num="(6)"> <text>Applies to the Board within 5 years of the date the license expired.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to Reinstate Within 5 Years.</text> <paragraph num="(1)"> <text>The Board may not reinstate the license of a social worker who fails to apply for reinstatement within 5 years after the license expired.</text> </paragraph> <paragraph num="(2)"> <text>The Board may issue a license after 5 years if the individual:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(b)"> <text>Submits the required application;</text> </paragraph> <paragraph num="(c)"> <text>Pays all applicable fees set forth in COMAR 10.42.05;</text> </paragraph> <paragraph num="(d)"> <text>Submits an official transcript indicating the date the degree was awarded or conferred;</text> </paragraph> <paragraph num="(e)"> <text>Submits three general professional references; and</text> </paragraph> <paragraph num="(f)"> <text>Passes the respective examination required for initial licensure.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Inactive Status."> <paragraph num="A."> <text>A licensee who wishes to place a license on inactive status may do so by:</text> <paragraph num="(1)"> <text>Submission of a written application which contains the:</text> <paragraph num="(a)"> <text>Date the license is to be placed on inactive status;</text> </paragraph> <paragraph num="(b)"> <text>License number; and</text> </paragraph> <paragraph num="(c)"> <text>Signature of the licensee requesting the inactive status of the license; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Payment of the appropriate fee for the status set forth in COMAR 10.42.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A license may be placed on inactive status for a maximum of 5 years from the expiration date of the license.</text> </paragraph> <paragraph num="C."> <text>The Board shall reactivate a license of an individual who placed the license on inactive status for any reason if the individual:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Complies with the continuing education requirements established in COMAR 10.42.06;</text> </paragraph> <paragraph num="(3)"> <text>Submits an application for reactivation;</text> </paragraph> <paragraph num="(4)"> <text>Submits a continuing education report form with copies of the required documentation established in COMAR 10.42.06;</text> </paragraph> <paragraph num="(5)"> <text>Pays to the Board a reactivation fee set forth in COMAR 10.42.05; and</text> </paragraph> <paragraph num="(6)"> <text>Applies to the Board within 5 years of the date the license expired.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Failure to Reactivate Within 5 years.</text> <paragraph num="(1)"> <text>The Board may not reactivate the license of a social worker who fails to apply for reactivation within 5 years after the license expired.</text> </paragraph> <paragraph num="(2)"> <text>The Board may issue a license after 5 years if the individual:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(b)"> <text>Submits the required application;</text> </paragraph> <paragraph num="(c)"> <text>Pays all applicable fees set forth in COMAR 10.42.05;</text> </paragraph> <paragraph num="(d)"> <text>Submits an official transcript indicating the date the degree was awarded or conferred;</text> </paragraph> <paragraph num="(e)"> <text>Submits three general professional references; and</text> </paragraph> <paragraph num="(f)"> <text>Passes the respective examination required for initial licensure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee may place a license on inactive status for a maximum of 5 years per application for inactive status.</text> </paragraph> <paragraph num="F."> <text>Each period of inactive status may not exceed 5 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Replacement of Wall Certificates."> <paragraph num="A."> <text>The Board shall issue a replacement wall certificate upon written request by a licensee.</text> </paragraph> <paragraph num="B."> <text>If an original wall certificate is replaced, the licensee shall retain the original license number issued.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§19-101—19-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 10, 1976 (3:23 Md. R. 1302)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07, .13, and .16 amended effective May 23, 1983 (10:10 Md. R. 873)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 30, 1990 (17:8 Md. R. 976)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.04 and .16 amended, and new Regulation .04-1 adopted as an emergency provision effective September 15, 1993 (20:20 Md. R. 1565); adopted permanently effective December 1, 1993 (20:22 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.22 repealed and new Regulations .01—.19 adopted effective April 12, 2004 (31:7 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 4, 2011 (38:7 Md. R. 432); April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, c amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed and new Regulation .12 adopted effective April 4, 2011 (38:7 Md. R. 432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B, D amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective February 8, 2010 (37:3 Md. R. 176); April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective February 8, 2010 (37:3 Md. R. 176); April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 8, 2010 (37:3 Md. R. 176); April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective February 8, 2010 (37:3 Md. R. 176)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F, G amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D, E amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> </annotations> </chapter> <chapter num="02" heading="Social Work Practice"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to individuals authorized to practice social work under Health Occupations Article, Title 19, Subtitle 3, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advocacy” means the service in which the social worker acts on behalf of clients to bring about or influence change to improve the quality of life and functioning and assure the basic rights of the client.</text> </paragraph> <paragraph num="(2)"> <text>“Assessment” means obtaining and analyzing information about a client and the client’s circumstance while using appropriate social work knowledge, skills, values, and theory to develop a service, intervention, or treatment plan.</text> </paragraph> <paragraph num="(3)"> <text>"Board” means the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="(4)"> <text>“Case management” means a method of providing services by which a social worker assesses the needs of a client and arranges, coordinates, monitors, evaluates, and advocates for services to meet the needs of the client.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means individuals, groups, families, communities, and organizations.</text> </paragraph> <paragraph num="(6)"> <text>Clinical Social Work.</text> <paragraph num="(a)"> <text>“Clinical social work” means the professional application of social work knowledge, skills, values, theories, and methods for the treatment and prevention of psychosocial dysfunction, disability, or impairment, including emotional disorders, mental disorders, and substance use disorders with individuals, groups, and families.</text> </paragraph> <paragraph num="(b)"> <text>“Clinical social work” includes formulating a diagnostic impression and diagnosis based on standard diagnostic criteria.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Counseling” means a method used by social workers to assist clients in learning how to solve problems and make decisions about personal, health, social, educational, vocational, financial, and other interpersonal concerns.</text> </paragraph> <paragraph num="(8)"> <text>“Independent practice” means the practice of licensed social work without the requirement of social work supervision.</text> </paragraph> <paragraph num="(9)"> <text>“Informed consent” means a client’s decision to agree to a proposed course of transactions between the client and the licensee after the client has received reasonably full and accurate information pertaining to the risks, benefits, and possible consequences of the transaction.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed” means that the individual possesses a license to practice social work issued by the Board.</text> </paragraph> <paragraph num="(11)"> <text>“Licensee” means an individual licensed by the Board.</text> </paragraph> <paragraph num="(12)"> <text>Practice Social Work.</text> <paragraph num="(a)"> <text>“Practice social work” has the meaning stated in Health Occupations Article, §19-101(p), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Practice social work” includes supervising a candidate for advanced licensure, for independent practice, or a licensee in the practice of social work.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Private Practice.</text> <paragraph num="(a)"> <text>“Private practice” means the provision of psychotherapy by a licensed certified social worker-clinical (LCSW-C) who assumes responsibility and accountability for the nature and quality of services provided to a client in exchange for direct payment or third-party reimbursement or on a pro-bono basis as stated in Health Occupations Article, §19-101(q), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Private practice” includes the terms solo practice, solo private practice, or group practice.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Pro-bono” means the provision of psychotherapy or social work services for no or low payment based on need.</text> </paragraph> <paragraph num="(15)"> <text>“Psychotherapy” means formulating a diagnostic impression and an assessment for the treatment of mental and behavioral disturbances while utilizing a specialized formal interaction between the client and the social worker in which a therapeutic relationship is established and maintained.</text> </paragraph> <paragraph num="(16)"> <text>“Scope of practice” means procedures, actions, and processes that a licensed social worker is permitted to undertake in accordance with the terms of the license held.</text> </paragraph> <paragraph num="(17)"> <text>“Social work” means the professional activity of helping individuals, families, groups, couples, organizations, or communities to enhance or restore their capacity for social and psychosocial functioning.</text> </paragraph> <paragraph num="(18)"> <text>“Social worker” means an individual who:</text> <paragraph num="(a)"> <text>Is licensed under the Health Occupations Article, Title 19, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Represents to the public by title or description which incorporates the words “social worker”, “social work”, or a similar designation; and</text> </paragraph> <paragraph num="(c)"> <text>Offers, attempts, or renders services involving the application of principles, methods, and procedures of the social work profession to clients.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee in which the supervisor directs, monitors, and evaluates the supervisee’s social work practice while promoting the development of the supervisee’s knowledge, skills, and abilities to provide social work services in an ethical and competent manner.</text> </paragraph> <paragraph num="(20)"> <text>Technology Used.</text> <paragraph num="(a)"> <text>“Technology used" means the use of interactive audio, video, or other telecommunications or electronic media by a social worker to deliver social work services.</text> </paragraph> <paragraph num="(b)"> <text>“Technology used” includes, but is not limited to services that are provided to a client who is not physically present with the social worker.</text> </paragraph> <paragraph num="(c)"> <text>“Technology used” does not include:</text> <paragraph num="(i)"> <text>Audio phonic or telephonic communications between an LCSW-C and a client;</text> </paragraph> <paragraph num="(ii)"> <text>Electronic communications between an LCSW-C and a client;</text> </paragraph> <paragraph num="(iii)"> <text>Facsimile transmission between an LCSW-C and a client; or</text> </paragraph> <paragraph num="(iv)"> <text>A text message or other type of message sent between an LCSW-C and a client by a short message service or multimedia service.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope of Practice."> <paragraph num="A."> <text>Licensed Bachelor Social Worker (LBSW).</text> <paragraph num="(1)"> <text>An LBSW shall practice social work under a social work supervisor and may include practice social work as stated in Health Occupations Article, §§19-101(m) and 19-307(c)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>An LBSW’s practice includes the basic, generalist practice of social work which includes:</text> <paragraph num="(a)"> <text>Assessment;</text> </paragraph> <paragraph num="(b)"> <text>Planning;</text> </paragraph> <paragraph num="(c)"> <text>Intervention;</text> </paragraph> <paragraph num="(d)"> <text>Evaluation;</text> </paragraph> <paragraph num="(e)"> <text>Case management;</text> </paragraph> <paragraph num="(f)"> <text>Information and referral;</text> </paragraph> <paragraph num="(g)"> <text>Counseling;</text> </paragraph> <paragraph num="(h)"> <text>Supervision;</text> </paragraph> <paragraph num="(i)"> <text>Consultation;</text> </paragraph> <paragraph num="(j)"> <text>Education;</text> </paragraph> <paragraph num="(k)"> <text>Advocacy;</text> </paragraph> <paragraph num="(l)"> <text>Community organization; and</text> </paragraph> <paragraph num="(m)"> <text>The development, implementation and administration of policies, programs, and activities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An LBSW’s practice may not include:</text> <paragraph num="(a)"> <text>Making a clinical diagnosis of a mental or emotional disorder;</text> </paragraph> <paragraph num="(b)"> <text>Providing psychotherapy; or</text> </paragraph> <paragraph num="(c)"> <text>Engaging in private practice.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An LBSW may not engage in the practice of social work independent of social work supervision unless approved by the Board for independent practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensed Master Social Worker (LMSW).</text> <paragraph num="(1)"> <text>An LMSW shall practice social work under a social work supervisor and may practice social work as stated in Health Occupations Article, §§19-101(p) and 19-307(c)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>An LMSW’s practice is characterized by the application of specialized knowledge and advanced practice skills in the areas of:</text> <paragraph num="(a)"> <text>Assessment;</text> </paragraph> <paragraph num="(b)"> <text>Planning;</text> </paragraph> <paragraph num="(c)"> <text>Intervention;</text> </paragraph> <paragraph num="(d)"> <text>Evaluation;</text> </paragraph> <paragraph num="(e)"> <text>Case management;</text> </paragraph> <paragraph num="(f)"> <text>Information and referral;</text> </paragraph> <paragraph num="(g)"> <text>Counseling;</text> </paragraph> <paragraph num="(h)"> <text>Supervision;</text> </paragraph> <paragraph num="(i)"> <text>Consultation;</text> </paragraph> <paragraph num="(j)"> <text>Education;</text> </paragraph> <paragraph num="(k)"> <text>Advocacy;</text> </paragraph> <paragraph num="(l)"> <text>Community organization; and</text> </paragraph> <paragraph num="(m)"> <text>The development, implementation, and administration of policies, programs, and activities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An LMSW’s practice may not include the treatment of emotional disorders, psychotherapy, or diagnosis of a mental disorder without the supervision of an LCSW-C.</text> </paragraph> <paragraph num="(4)"> <text>An LMSW may not engage in the practice of social work independent of social work supervision unless approved by the Board for independent practice.</text> </paragraph> <paragraph num="(5)"> <text>On or before December 31, 2019, an LMSW may not engage in private practice without the supervision of an LCSW-C.</text> </paragraph> <paragraph num="(6)"> <text>On or after January 1, 2020, an LMSW may not engage in private practice as defined in Regulation .02B(14) of this chapter.</text> </paragraph> <paragraph num="(7)"> <text>On or after January 1, 2020, an LMSW may be employed in a private practice working under the supervision of an LCSW-C.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Licensed Certified Social Worker (LCSW).</text> <paragraph num="(1)"> <text>An LCSW may:</text> <paragraph num="(a)"> <text>Practice social work as stated in Health Occupations Article, §§19-101(m) and 19-307(c)(3), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Provide supervision of other social workers in accordance with COMAR 10.42.08; and</text> </paragraph> <paragraph num="(c)"> <text>Practice social work independent of supervision when the practice does not include diagnosis, treating mental disorders or providing psychotherapy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An LCSW’s practice may not include the treatment of emotional disorders, psychotherapy, or diagnosis for a mental disorder without the supervision of an LCSW-C.</text> </paragraph> <paragraph num="(3)"> <text>On or after January 1, 2020, an LCSW may not engage in private practice as defined in Regulation .02B(14) of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>On or after January 1, 2020, an LCSW may be employed in a private practice working under the supervision of an LCSW-C.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Licensed Certified Social Worker-Clinical (LCSW-C). An LCSW-C may:</text> <paragraph num="(1)"> <text>Practice social work as stated in Health Occupations Article, §19-101(m), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision of other social workers as set forth in COMAR 10.42.05;</text> </paragraph> <paragraph num="(3)"> <text>Evaluate, diagnose and treat biopsychosocial conditions, mental and emotional conditions and impairments, and mental disorders as defined in Health-General Article, §10-101(f), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Petition for emergency evaluation under Health-General Article, Title 10, Subtitle 6, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Provide person-to person psychotherapy;</text> </paragraph> <paragraph num="(6)"> <text>Have a private practice; and</text> </paragraph> <paragraph num="(7)"> <text>Practice clinical social work as stated in Health Occupations Article §19-401(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Case Management."> <paragraph num="A."> <text>A licensed social worker shall meet the standards outlined in this regulation when involved in case management, whether or not the licensee shares case management responsibilities with others as a member of a multidisciplinary team.</text> </paragraph> <paragraph num="B."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Affirm the worth and dignity of the individual client as well as mutual responsibility in decision making;</text> </paragraph> <paragraph num="(2)"> <text>Promote client self-determination by assuring client involvement in planning and implementation of services;</text> </paragraph> <paragraph num="(3)"> <text>Keep the interest of the client as the focus of all case management activities; and</text> </paragraph> <paragraph num="(4)"> <text>Assure appropriate confidentiality of client information.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Independent Practice."> <paragraph num="A."> <text>An LCSW-C may engage in the independent practice of social work.</text> </paragraph> <paragraph num="B."> <text>An LCSW may engage in the independent practice of social work, except when formulating a diagnostic impression, a diagnosis, or providing psychotherapy.</text> </paragraph> <paragraph num="C."> <text>An LBSW or LMSW may not engage in the independent practice of social work until the licensee is approved by the Board for independent status in accordance with this regulation.</text> </paragraph> <paragraph num="D."> <text>An LBSW or LMSW shall practice in accordance with the restrictions set forth in Health Occupations Article, §19-307, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>An LBSW or LMSW licensed on or before January 1, 2008 shall:</text> <paragraph num="(1)"> <text>Have actively practiced bachelor or master social work under social work supervision;</text> </paragraph> <paragraph num="(2)"> <text>Have completed at least 10 years of social work experience under social work supervision;</text> </paragraph> <paragraph num="(3)"> <text>Submit an application in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Provide documentation in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An LBSW or LMSW licensed on or after January 1, 2008 shall:</text> <paragraph num="(1)"> <text>Have actively practiced bachelor or master social work under social work supervision;</text> </paragraph> <paragraph num="(2)"> <text>Have completed at least 3 years as an active licensee with at least 4,500 hours and a minimum of 150 hours of periodic face-to-face supervision;</text> </paragraph> <paragraph num="(3)"> <text>Submit an application in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Provide documentation in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An LBSW or LMSW licensed on or after January 1, 2021 shall:</text> <paragraph num="(1)"> <text>Have actively practiced bachelor or master social work under the supervision of Board approved social work supervision;</text> </paragraph> <paragraph num="(2)"> <text>Have completed at least 3 years as an active licensee with at least 4,500 hours and a minimum of 150 hours of periodic face-to-face supervision;</text> </paragraph> <paragraph num="(3)"> <text>Submit an application in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Provide documentation in the form prescribed by the Board as set forth in Health Occupations Article, §19-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Board shall approve an application to engage in independent practice provided:</text> <paragraph num="(1)"> <text>The application is complete; and</text> </paragraph> <paragraph num="(2)"> <text>The applicant practiced social work in accordance with the statute and regulations in effect at the time the bachelor or master social worker practiced in Maryland.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Board may not approve the licensee to engage in independent practice if the licensee fails to demonstrate the required supervised experience.</text> <paragraph num="(1)"> <text>The Board may require the applicant to complete up to 1,500 additional hours of supervised social work experience; and</text> </paragraph> <paragraph num="(2)"> <text>The applicant may reapply for independent practice following the completion of the required social work experience.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §19-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 24, 2000 (27:14 Md. R. 1342)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 17, 2019 (46:12 Md. R. 544)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <paragraph num="A."> <text>This chapter governs the professional conduct of social workers licensed by the Board regardless of whether the service delivery is in person, telephonically, or electronically.</text> </paragraph> <paragraph num="B."> <text>The objective of this chapter is the protection of the public, which shall be the primary guide in determining the appropriate professional conduct of all individuals whose activities are regulated by the Board.</text> </paragraph> <paragraph num="C."> <text>A social worker has a responsibility to practice ethically by considering the potential benefit versus risk of harm to clients when planning and delivering professional social work services, including respecting and facilitating clients’ rights to make informed decisions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Client” means the individual, couple, family, group, or organization to whom the licensee is rendering professional service.</text> </paragraph> <paragraph num="(3)"> <text>“Dual relationship” means a relationship in which a licensee is involved with a client professionally and in any other capacity.</text> </paragraph> <paragraph num="(4)"> <text>“Impairment” means a licensee whose diminished capacity affects the licensee’s practice of social work.</text> </paragraph> <paragraph num="(5)"> <text>“Inappropriate sexual language” means:</text> <paragraph num="(a)"> <text>An eroticized or sexually provocative comment; or</text> </paragraph> <paragraph num="(b)"> <text>An inappropriate discussion of a sexual matter unrelated to client treatment.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Sexual behavior” means:</text> <paragraph num="(a)"> <text>A sexual act as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Sexual contact as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Sexual exploitation” means a situation in which the licensee takes advantage of the unequal relationship between the licensee and client, a student, or a supervisee to obtain sexual favors.</text> </paragraph> <paragraph num="(8)"> <text>“Sexual harassment” means:</text> <paragraph num="(a)"> <text>A deliberate or repeated comment of a sexual nature unrelated to client treatment; or</text> </paragraph> <paragraph num="(b)"> <text>An advance, gesture, solicitation, request, intimidation, or physical contact of a sexual nature.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Sexual misconduct” means:</text> <paragraph num="(a)"> <text>Inappropriate sexual language;</text> </paragraph> <paragraph num="(b)"> <text>Sexual exploitation;</text> </paragraph> <paragraph num="(c)"> <text>Sexual harassment;</text> </paragraph> <paragraph num="(d)"> <text>Sexual behavior; or</text> </paragraph> <paragraph num="(e)"> <text>Therapeutic deception.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Supervisee” means the individual to whom the licensee provides professional, educational, or administrative supervision or direction.</text> </paragraph> <paragraph num="(11)"> <text>“Therapeutic deception” means a representation by a licensee that sexual contact or sexual activity by or with the client is consistent with or part of the client's treatment.</text> </paragraph> <paragraph num="(12)"> <text>“Therapeutic relationship” means the relationship between a licensee and a client, in the practice of social work.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Responsibilities to Clients."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Apprise the client of the risks, opportunities, and obligations associated with services available to the client;</text> </paragraph> <paragraph num="(2)"> <text>Make the fee for service clear, maintain accurate financial records, stipulate payment schedules, and confirm arrangements for financial reimbursement with the client;</text> </paragraph> <paragraph num="(3)"> <text>Notify the client promptly and seek the transfer, referral, or continuation of service in relation to the client's need or preference if the licensee anticipates the termination or interruption of service;</text> </paragraph> <paragraph num="(4)"> <text>Prepare and disseminate to an identified colleague or record custodian a written plan for the transfer of clients and files in the event of the licensee's incapacitation, death, or termination of service; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation in the client's record which:</text> <paragraph num="(a)"> <text>Is legible;</text> </paragraph> <paragraph num="(b)"> <text>Accurately reflects the services provided, including treatment plans, treatment goals, and contact notes;</text> </paragraph> <paragraph num="(c)"> <text>Indicates the time and date the services were provided;</text> </paragraph> <paragraph num="(d)"> <text>Protects the client's privacy by including only information directly relevant to the delivery of services;</text> </paragraph> <paragraph num="(e)"> <text>Is sufficient and timely to facilitate the delivery and continuity of future services;</text> </paragraph> <paragraph num="(f)"> <text>Is reasonably accessible for the period required in Health General Article, §4-403, Annotated Code of Maryland, after termination of services; and</text> </paragraph> <paragraph num="(g)"> <text>Ensures that no confidential information is disseminated and identities are protected when using technology to communicate or access client information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee may not:</text> <paragraph num="(1)"> <text>Participate or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Misrepresent professional qualifications, education, experience, or affiliation;</text> </paragraph> <paragraph num="(3)"> <text>Exploit a relationship with a client for personal advantage or satisfaction;</text> </paragraph> <paragraph num="(4)"> <text>Engage in solicitation which amounts to fraud, intimidation, or undue influence;</text> </paragraph> <paragraph num="(5)"> <text>Practice, condone, facilitate, or collaborate with discrimination on the basis of race, gender, sexual orientation, age, religion, national origin, socioeconomic status, disability, or any other basis proscribed by law;</text> </paragraph> <paragraph num="(6)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(7)"> <text>Share with another individual a confidence revealed by a client without a client's consent, except if there is danger to self or to another individual, or for a compelling professional reason; or</text> </paragraph> <paragraph num="(8)"> <text>Share a fee or accept or give something of value for receiving or making a referral.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibilities to Colleagues."> <paragraph num="A."> <text>The licensee shall inform the Board of:</text> <paragraph num="(1)"> <text>Unethical conduct by a licensed social worker; and</text> </paragraph> <paragraph num="(2)"> <text>An individual who is not licensed by the Board but who represents that the individual is a social worker and is practicing, attempting to practice, or offering to practice social work.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensees may not sexually harass, verbally abuse, or intimidate supervisees, students, trainees, or colleagues.</text> </paragraph> <paragraph num="C."> <text>Licensees having knowledge of a colleague’s impairment or incompetence should take reasonable measures to assist the colleague in taking remedial action. In cases where the colleague does not address the problem, or in any case in which welfare of a client appears to be in danger, the licensee shall report the impairment or incompetence to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Relationships."> <paragraph num="A."> <text>The licensee may not enter into a dual relationship with a client or an individual with whom the client has a close personal relationship.</text> </paragraph> <paragraph num="B."> <text>Adoption of a Former Client. The Board may make an exception to §A of this regulation in the case of a licensee seeking the adoption of a former client under what is deemed extraordinary circumstances as a result of a Board investigation.</text> </paragraph> <paragraph num="C."> <text>The licensee may enter into a nonsexual relationship with an individual with whom the licensee’s prior professional contact:</text> <paragraph num="(1)"> <text>Was of a brief, peripheral, or indirect nature; and</text> </paragraph> <paragraph num="(2)"> <text>Did not constitute a therapeutic relationship.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The licensee may not engage in sexual misconduct with either current or former clients.</text> </paragraph> <paragraph num="E."> <text>The licensee may not engage in sexual misconduct with a client, supervisee, student, trainee, or colleague over whom the licensee exercises professional authority.</text> </paragraph> <paragraph num="F."> <text>The licensee may not terminate professional services or a professional relationship with a client in order to enter into a nonprofessional, social, or sexual relationship with the client or an individual with whom the client has a personal relationship.</text> </paragraph> <paragraph num="G."> <text>Prior Sexual Relationships. The licensee may not provide professional services to an individual with whom the licensee has previously engaged in sexual behavior.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standards of Practice."> <paragraph num="A."> <text>Professional Competence. The licensee shall:</text> <paragraph num="(1)"> <text>Limit practice to the areas in which the licensee has gained proficiency through education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Acquire specialized education and training in order to provide the client with services that are culturally informed;</text> </paragraph> <paragraph num="(3)"> <text>Use interventions and assessment techniques only when the licensee knows that the circumstances justify those interventions and techniques;</text> </paragraph> <paragraph num="(4)"> <text>Monitor the effectiveness of a licensee’s interventions;</text> </paragraph> <paragraph num="(5)"> <text>Maintain and enhance professional competence by meeting the requirements of continuing education as set forth in COMAR 10.42.06;</text> </paragraph> <paragraph num="(6)"> <text>Engage in ongoing consultation with other professionals with relevant knowledge, experience, and training, when developing competence in a new service or technique;</text> </paragraph> <paragraph num="(7)"> <text>Document and maintain appropriate and accurate records of professional service, supervision, and research work;</text> </paragraph> <paragraph num="(8)"> <text>Represent accurately the licensee’s professional qualifications; and</text> </paragraph> <paragraph num="(9)"> <text>Seek competent professional assistance to determine whether to suspend, terminate, or limit the scope of professional or scientific activities when the licensee becomes aware that the licensee’s competence is impaired.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee may not:</text> <paragraph num="(1)"> <text>Undertake or continue a professional relationship with a client when the competence or objectivity of the licensee is or could reasonably be expected to be impaired due to:</text> <paragraph num="(a)"> <text>Mental, emotional, physiological, pharmacological, substance abuse, or personal problems; or</text> </paragraph> <paragraph num="(b)"> <text>The licensee’s present or previous familial, social, sexual, emotional, financial, supervisory, political, administrative, legal, or other relationship with the client or a person associated with or related to the client; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Engage in other relationships that could limit the licensee’s objectivity or create a conflict of interest or the appearance of a conflict of interest.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Research. A licensee shall:</text> <paragraph num="(1)"> <text>Comply with all requirements under Health General Article, §§13-2001—13-2004, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Obtain informed consent from a client for participation in research that clearly defines for the client:</text> <paragraph num="(a)"> <text>Why the client is being asked to participate;</text> </paragraph> <paragraph num="(b)"> <text>What modalities will be employed;</text> </paragraph> <paragraph num="(c)"> <text>What standardized instruments will need to be completed;</text> </paragraph> <paragraph num="(d)"> <text>The timeline for the consent;</text> </paragraph> <paragraph num="(e)"> <text>Any potential benefits; and</text> </paragraph> <paragraph num="(f)"> <text>Any potential adverse reactions;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Inform the client of the client’s right to discontinue participation in the research;</text> </paragraph> <paragraph num="(4)"> <text>Provide the client with treatment options and referral sources in the event of an adverse reaction;</text> </paragraph> <paragraph num="(5)"> <text>Respect the dignity and protect the welfare of the research subject, and comply with all relevant statutes, regulations, and institutional and administrative rules concerning treatment of the research participant;</text> </paragraph> <paragraph num="(6)"> <text>Ensure the ethical treatment of the research participant by collaborators, supervisees, and employees;</text> </paragraph> <paragraph num="(7)"> <text>Make clear, either as a researcher or a writer, the:</text> <paragraph num="(a)"> <text>Nature of the participation;</text> </paragraph> <paragraph num="(b)"> <text>Costs; and</text> </paragraph> <paragraph num="(c)"> <text>Licensee’s obligations to the research participants; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Report research findings accurately, presenting only the licensee’s work or making appropriate citations when needed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The licensee engaging in physical, nonsexual contact with a client as an accepted component of a professionally recognized, nontraditional treatment modality shall document in the client’s record:</text> <paragraph num="(1)"> <text>An assessment of the client;</text> </paragraph> <paragraph num="(2)"> <text>A written rationale for the use of the treatment modality for the client; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the informed consent signed and dated by the client and the licensee, which addresses:</text> <paragraph num="(a)"> <text>The risks and benefits of the treatment modality;</text> </paragraph> <paragraph num="(b)"> <text>The objective or objectives and intended outcome or outcomes of the proposed treatment;</text> </paragraph> <paragraph num="(c)"> <text>Available alternative interventions; and</text> </paragraph> <paragraph num="(d)"> <text>A description of the physical contact which may be reasonably anticipated by the client in the course of the proposed treatment.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Sanctions."> <paragraph num="A."> <text>The licensee who engages in ethical misconduct is subject to sanctions by the Board.</text> </paragraph> <paragraph num="B."> <text>The Board shall notify the National Practitioner Data Bank of any formal sanction of a licensee on the grounds of ethical misconduct.</text> </paragraph> <paragraph num="C."> <text>The licensee may not prohibit the client from reporting misconduct as a condition of settlement of a legal cause of action.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 19-101—19-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 23, 1983 (10:10 Md. R. 873)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective April 2, 1990 (17:6 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended as an emergency provision effective September 15, 1993 (20:20 Md. R. 1565); amended permanently effective December 1, 1993 (20:22 Md. R. 1707)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 repealed and new Regulations .01—.06 adopted effective October 4, 1999 (26:20 Md. R. 1546)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 5, 2002 (29:15 Md. R. 1142)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="04" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Social Work Examiners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference committee” means a committee composed of one or more members of the Board that makes recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(7)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of social work.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Charging document” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Social Workers Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth provisions of the Maryland Social Workers Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Complaint” means a written allegation received by the Board that a licensee may have violated the Maryland Social Workers Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Consent order” means a public record issued by the Board that is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(11)"> <text>“Contested case” means a proceeding conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(12)"> <text>“Disposition agreement” means a formal nonpublic agreement entered into with an impaired licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(13)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may do by law.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Imperatively requires emergency action” means a finding by the Board that an emergency action be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(15)"> <text>“Informal action” means that the Board closes a case without taking formal disciplinary action or without issuing a final order, by imposing a disciplinary sanction consisting of a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment;</text> </paragraph> <paragraph num="(c)"> <text>Cease and desist letter; or</text> </paragraph> <paragraph num="(d)"> <text>Consent agreement.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Investigation” means the gathering of information to assist the Board in determining if there is reasonable cause to charge a licensee with a violation of the Maryland Social Workers Act.</text> </paragraph> <paragraph num="(17)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing a case, if the Board believes a licensee has engaged in conduct that violates the Maryland Social Workers Act, admonishing the licensee not to repeat the conduct.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may include an agreement that the licensee perform certain conditions instead of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Letter of education” means informal action consisting of a nonpublic letter to a licensee:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Social Workers Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of social work.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the license to practice social work.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Licensure” means permission to engage in the practice of social work which is evidenced by a license issued by the Board.</text> </paragraph> <paragraph num="(21)"> <text>“Maryland Social Workers Act” means Health Occupations Article, Title19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, a change in licensure status, or some other benefit sought by the licensee.</text> </paragraph> <paragraph num="(23)"> <text>“Postdeprivation hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(24)"> <text>“Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why it should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action that the Board may by law take.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Preliminary investigation” means the gathering of information to be used by the Board to determine if the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Social Workers Act.</text> </paragraph> <paragraph num="(26)"> <text>“Probation” means a sanction imposed by the Board in a public final order in which the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Prohibited act” means conduct specified in the Maryland Social Workers Act which may result in sanctions or penalties.</text> </paragraph> <paragraph num="(28)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Recommended decision” means a nonpublic record issued to the Board by an administrative law judge that sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of them.</text> </paragraph> <paragraph num="(30)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in a case.</text> </paragraph> <paragraph num="(31)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, that has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of the Maryland Social Workers Act;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential emergency suspension under State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Notified as to potential violation of Health Occupations Article, §19-401, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Revocation” means the removal of a social worker's license to practice social work.</text> </paragraph> <paragraph num="(33)"> <text>“Sanction” means an action by the Board, including a:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Placement on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fine; or</text> </paragraph> <paragraph num="(d)"> <text>Suspension or revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Show cause hearing” means a nonevidentiary hearing before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board may take.</text> </paragraph> <paragraph num="(35)"> <text>“Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions.</text> </paragraph> <paragraph num="(36)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, taken if the Board believes the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(37)"> <text>“Surrender” means the voluntary relinquishing of a license to practice social work that may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(38)"> <text>“Suspension” means a temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specific period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Violation” means an act or omission prohibited under Health Occupations Article, §19-311, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this section.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings' proceedings involving the adjudication of a Board-contested case and the administrative law judge's recommended decision are confidential. The respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, the respondent shall be represented in proper person or by an attorney who has been admitted to the Maryland Bar or specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>In all proceedings, the Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings under Health Occupations Article, §19-311, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Make a preliminary review of each complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Recommend that cases involving complaints over which the Board lacks jurisdiction be closed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee that is the subject of the complaint, to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(3)"> <text>Board subpoenas may be issued by the Board over the signature of the administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>After reviewing any completed investigative information or reports for each complaint, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(c)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(d)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(e)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(f)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §19-311, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether it has voted to charge a licensee with violations of the Maryland Social Workers Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(a)"> <text>Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Hand-delivered in person; or</text> </paragraph> <paragraph num="(c)"> <text>Served by other means reasonable to effect service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Social Workers Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> <paragraph num="(4)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D1(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party, not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness that will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §D(2)(a) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments on the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §D(2)(a)(ii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(a)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in Regulation .05E(1) of this chapter, the Board may deny a respondent's request for a case resolution conference.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="(5)"> <text>Recommendations of the case resolution conference are not binding on the Board, which may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>The Board may require conditions for surrender of a license, including:</text> <paragraph num="(a)"> <text>An admission of a violation of the Maryland Social Workers Act;</text> </paragraph> <paragraph num="(b)"> <text>An admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the Board determines that disclosure of the surrender is not in the public interest, a letter of surrender is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings may not be open to the public.</text> </paragraph> <paragraph num="(4)"> <text>All records, including the recommended decision, shall be confidential and sealed.</text> </paragraph> <paragraph num="(5)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>A combination of §B(5)(a)—(c) of this regulation pursuant to the Board's delegation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>A licensee to whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Social Workers Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise permitted by the Board, within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages, and shall state with particularity the finding of fact, conclusion of law, or other matter excepted to, and the relevant portions of the record supporting the party's exception.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise permitted by the Board, within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party's response to an answer to the exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties' exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient progress of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The respondent and the administrative prosecutor each may not exceed 30 minutes to present oral argument.</text> </paragraph> <paragraph num="(f)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in an answer to exceptions or in the hearing on exceptions, reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>Upon a finding that there has been a violation of the Maryland Social Workers Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Pursuant to its authority under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact that the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed to prosecute the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity to Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>Predeprivation Show Cause Hearing Before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not duly repetitious, if the presiding Board member believes that such documents or exhibits are necessary for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension Without Prior Notice or Hearing Opportunity.</text> <paragraph num="(1)"> <text>Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend license or providing a respondent with an opportunity for a predeprivation hearing if the Board determines that:</text> <paragraph num="(a)"> <text>The public health, safety, and welfare require the immediate suspension of the license; and</text> </paragraph> <paragraph num="(b)"> <text>Prior notice and an opportunity to be heard are not feasible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Time—Service and Hearing.</text> <paragraph num="(a)"> <text>An order of summary suspension under §D(1) of this regulation shall be served upon the respondent within 24 hours after its execution.</text> </paragraph> <paragraph num="(b)"> <text>The respondent shall be provided an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall:</text> <paragraph num="(a)"> <text>Be conducted before the Board as provided in §D(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Postdeprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license under §C or D of this regulation, the respondent shall be provided with an opportunity for an evidentiary hearing before the Board, or if the Board delegates the matter to the Office of Administrative Hearings, before an administrative law judge.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after respondent's request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge shall issue a recommended decision to the Board with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a)—(c) of this regulation, pursuant to the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge's determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exceptions to the recommended decision, as provided in the State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a postdeprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board considers appropriate, including:</text> <paragraph num="(1)"> <text>Reeducation or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Providing free social work services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Practicing under supervision;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring by the Board or by an individual or entity approved by the Board, with periodic reporting to the Board;</text> </paragraph> <paragraph num="(6)"> <text>Periodic review of a licensee's clinical practices or billing;</text> </paragraph> <paragraph num="(7)"> <text>Periodic audits of a licensee's billing practices;</text> </paragraph> <paragraph num="(8)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(10)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(11)"> <text>Any other condition the Board considers appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when:</text> <paragraph num="(1)"> <text>The specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>The licensee has successfully completed the conditions or acts required for termination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action the final order or consent order provides for a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts that constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or failing to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .05E of this chapter.</text> </paragraph> <paragraph num="G."> <text>If the Board determines that a respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action the consent order or final order provides for a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a sanction or take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Restoration of a License."> <paragraph num="A."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for a termination of a suspension of a license or a reinstatement after revocation or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee that petitions the Board for reinstatement under the terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board, shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(3)"> <text>A licensee whose license has been revoked or surrendered for 5 or more years before filing a petition for reinstatement is ineligible for reinstatement but may apply for initial licensure.</text> </paragraph> <paragraph num="(4)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Hearing Opportunity.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, that notice shall be served as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the legal basis for the Board's belief that the applicant is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts the Board believes support the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference as provided in Regulation .06A of this chapter, to discuss settlement of the matter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or a delegated to an administrative law judge and conducted under the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, it may impose any restrictions or conditions on the license or the licensee's practice that it considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §19-313 and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Fines."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §19-312, Annotated Code of Maryland, and COMAR 10.42.04, the Board may impose a fine, in addition to, or instead of:</text> <paragraph num="(1)"> <text>Reprimanding a licensee;</text> </paragraph> <paragraph num="(2)"> <text>Placing a licensee on probation; or</text> </paragraph> <paragraph num="(3)"> <text>Suspending or revoking a license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether to impose a fine and the amount of the fine, the Board shall consider the following factors:</text> <paragraph num="(1)"> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="(2)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(3)"> <text>The extent to which the individual derived a financial benefit from the violation;</text> </paragraph> <paragraph num="(4)"> <text>The history of a previous violation or violations;</text> </paragraph> <paragraph num="(5)"> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="(6)"> <text>Mitigating factors as presented by the licensee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual shall pay the fine to the Board under the terms of the Board's order.</text> </paragraph> <paragraph num="D."> <text>The Board shall pay all monies collected under this chapter to the General Fund of the State.</text> </paragraph> <paragraph num="E."> <text>Unless the Board's order provides otherwise, if an individual fails to pay, in whole or in part, a fine imposed by the Board, the Board may not restore, reinstate, or renew the license of the individual until the individual pays the fine in full.</text> </paragraph> <paragraph num="F."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Cost Recovery."> <text>If after a hearing, a licensee is found to have violated any of the provisions of Health Occupations Article, §19-311, Annotated Code of Maryland, the Board shall be entitled to reimbursement of costs by the licensee including any or all of the following items:</text> <paragraph num="A."> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="B."> <text>Transcription of the hearing record by court reporters;</text> </paragraph> <paragraph num="C."> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="D."> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="E."> <text>Hearing-related per diems and expenses for Board members; and</text> </paragraph> <paragraph num="F."> <text>Other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§19-310—19-313 and 19-401; State Government Article, §§10-201—10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 23, 1983 (10:10 Md. R. 874)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective April 3, 2000 (27:6 Md. R. 642)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective April 3, 2000 (27:6 Md. R. 642)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.12 adopted effective September 30, 2002 (29:19 Md. R. 1525)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="05" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all persons licensed as social workers in the State and all persons, agencies, institutions, or organizations seeking to provide continuing education programs who submit applications to the Board for sponsorship authorization and program approval under the requirements of COMAR 10.42.06.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>The following fees are established by the Board:</text> <paragraph num="(1)"> <text>Application processing fee — $100;</text> </paragraph> <paragraph num="(2)"> <text>Initial license fee — $75;</text> </paragraph> <paragraph num="(3)"> <text>License renewal fee:</text> <paragraph num="(a)"> <text>Bachelor level — $100;</text> </paragraph> <paragraph num="(b)"> <text>Graduate level — $200;</text> </paragraph> <paragraph num="(c)"> <text>Certified level — $275;</text> </paragraph> <paragraph num="(d)"> <text>Certified-clinical level — $275;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Inactive status fee — $15;</text> </paragraph> <paragraph num="(5)"> <text>Reactivation processing fee to change from inactive status to active status:</text> <paragraph num="(a)"> <text>Bachelor level — $125;</text> </paragraph> <paragraph num="(b)"> <text>Graduate level — $225;</text> </paragraph> <paragraph num="(c)"> <text>Certified level — $300;</text> </paragraph> <paragraph num="(d)"> <text>Certified-clinical level — $300;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Reinstatement processing fee to change from non-renewed status to active status:</text> <paragraph num="(a)"> <text>Bachelor level — $125;</text> </paragraph> <paragraph num="(b)"> <text>Graduate level — $225;</text> </paragraph> <paragraph num="(c)"> <text>Certified level — $300;</text> </paragraph> <paragraph num="(d)"> <text>Certified-clinical level — $300;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Application for authorization to sponsor continuing education programs (required only if not automatically entitled to sponsor programs under COMAR 10.42.06):</text> <paragraph num="(a)"> <text>Application — $200;</text> </paragraph> <paragraph num="(b)"> <text>Program Approval — $100;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>License verification fee — $20;</text> </paragraph> <paragraph num="(9)"> <text>Penalty for returned checks — $50;</text> </paragraph> <paragraph num="(10)"> <text>Failure to notify the Board of change of address — $50;</text> </paragraph> <paragraph num="(11)"> <text>Supervisor registration fee — $20;</text> </paragraph> <paragraph num="(12)"> <text>Individual record retrieval fee — $30.</text> </paragraph> <paragraph num="(13)"> <text>Rosters:</text> <paragraph num="(a)"> <text>Bachelor or graduate levels — $80;</text> </paragraph> <paragraph num="(b)"> <text>Certified or certified-clinical levels — $150.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not refund a fee.</text> </paragraph> <paragraph num="C."> <text>The Maryland Health Care Commission may assess a fee for health care professionals which the applicant shall pay at the time of license renewal as specified in COMAR 10.25.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Change of Fees."> <paragraph num="A."> <text>Fees are subject to change by action of the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="B."> <text>The Board shall give notice of a change in fees to licensees and applicants by any reasonable means.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Maryland Health Care Commission Assessment for Health Care Practitioners."> <text>At the time of license renewal of a certified social worker—clinical, certified social worker, and a graduate social worker, an applicant shall pay to the Board a user fee assessed by the Maryland Health Care Commission, as specified annually in the Maryland Register pursuant to COMAR 10.25.02.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§19-205, 19-206, and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 2, 1990 (17:6 Md. R. 741)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective February 19, 1993 (19:24 Md. R. 2126)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted as an emergency provision effective April 15, 2001 (28:10 Md. R. 945); adopted permanently effective August 6, 2001 (28:15 Md. R. 1397)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02J adopted effective May 23, 1994 (21:10 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 12, 2003 (30:9 Md. R. 615); May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 25, 2008 (35:17 Md. R. 1489); February 8, 2010 (37:3 Md. R. 176); May 11, 2015 (42:9 Md. R. 647)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 12, 2003 (30:9 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E, G amended effective November 11, 2002 (29:22 Md. R. 1721)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective May 12, 2003 (30:9 Md. R. 615)</annotation> </annotations> </chapter> <chapter num="06" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope and Objectives."> <paragraph num="A."> <text>This chapter establishes continuing education requirements for licensed social workers in the State.</text> </paragraph> <paragraph num="B."> <text>The objectives of this chapter include:</text> <paragraph num="(1)"> <text>Maintenance and enhancement of professional competence;</text> </paragraph> <paragraph num="(2)"> <text>Ongoing improvement of professional skills and knowledge; and</text> </paragraph> <paragraph num="(3)"> <text>Enrichment of social work services provided to the citizens of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approved programs” means programs that are presented by professionals who are qualified in the content area with education as the focus and that:</text> <paragraph num="(a)"> <text>Are offered or provided under the auspices of an authorized sponsor; or</text> </paragraph> <paragraph num="(b)"> <text>Are offered or approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Authorized sponsor” means an individual, agency, or organization that is authorized to provide continuing education programs and to offer under its auspices programs as set forth in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Social Work Examiners.</text> </paragraph> <paragraph num="(4)"> <text>“Category I” means activities that are formally organized face-to-face, or live, real time interactive learning experiences provided authorized sponsors as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(5)"> <text>“Category II” means learning experiences as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Committee” means the Continuing Education Committee appointed by the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Continuing education” means completing approved programs designed to provide:</text> <paragraph num="(a)"> <text>Enhancement of professional social work practice, values, skills, and knowledge; and</text> </paragraph> <paragraph num="(b)"> <text>Enrichment of professional social work services and competence.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Continuing education unit” means 1 hour (60 minutes) of an approved program as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“County” means a county of Maryland and, unless expressly provided otherwise, Baltimore City.</text> </paragraph> <paragraph num="(10)"> <text>“Exception” means a deviation or departure from the continuing education requirements for circumstances set forth in Regulation .11 of this chapter that is granted at the discretion of the Board.</text> </paragraph> <paragraph num="(11)"> <text>“Extension” means a period of time, not to exceed 6 months for renewal, that the Board authorizes to permit additional time for a social worker with an active license to obtain the required continuing education units needed for renewal of a license as set forth in Regulation .10 of this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Nonprofit organization” means an organization that is tax exempt under 26 U.S.C. §501(c)(3)—(4).</text> </paragraph> <paragraph num="(13)"> <text>“Renewal date” means the date the license expires, as specified in the notice sent to the social worker by the Board in accordance with Health Occupations Article, §19-308(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Renewal period” means the period from the date the license was issued or November 1 of the renewal year to October 31 of the expiration year.</text> </paragraph> <paragraph num="(15)"> <text>“State” means:</text> <paragraph num="(a)"> <text>A state, possession, or territory of the United States;</text> </paragraph> <paragraph num="(b)"> <text>The District of Columbia; or</text> </paragraph> <paragraph num="(c)"> <text>The Commonwealth of Puerto Rico.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Continuing Education Requirements."> <paragraph num="A."> <text>The Board shall renew a license for an additional 2-year period if the social worker:</text> <paragraph num="(1)"> <text>Completes 40 (30 for Licensed Bachelor Social Workers) continuing education units within the renewal period, of which a minimum of:</text> <paragraph num="(a)"> <text>20 (15 for Licensed Bachelor Social Workers) continuing education units shall be obtained from approved programs which are Category I;</text> </paragraph> <paragraph num="(b)"> <text>3 of the required Category I or Category II continuing education units shall have a content area focusing on ethics and professional conduct, including boundary issues, or pertaining to the standards of practice and laws governing the profession of social work in Maryland;</text> </paragraph> <paragraph num="(c)"> <text>For registered and Board-approved supervisors, 3 of the required Category I or Category II continuing education units shall have a content area focusing on supervision as stipulated in COMAR 10.42.08.04B(3); and</text> </paragraph> <paragraph num="(d)"> <text>3 of the required Category I continuing education units shall have anti-oppressive social work practice content focusing on race, culture, or equity, and include one or more of the following topics:</text> <paragraph num="(i)"> <text>Cultural humility;</text> </paragraph> <paragraph num="(ii)"> <text>Social justice;</text> </paragraph> <paragraph num="(iii)"> <text>Racial equity;</text> </paragraph> <paragraph num="(iv)"> <text>Implicit bias; or</text> </paragraph> <paragraph num="(v)"> <text>Anti-racism practices;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Submits an application as set forth in COMAR 10.42.01 attesting to completion of the required continuing education units in approved programs; and</text> </paragraph> <paragraph num="(3)"> <text>Completes the required continuing education units within a 2-year period as set forth in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Time Frame.</text> <paragraph num="(1)"> <text>Renewed licenses are valid for a 2-year period from November 1 through and including October 31, during which time continuing education units may be earned.</text> </paragraph> <paragraph num="(2)"> <text>Continuing education units obtained in one renewal period may not be carried over to the next renewal period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Continuing Education Learning Activities."> <paragraph num="A."> <text>The social worker shall complete continuing education units relating to the practice of social work that foster improvement, advancement, and extension of the social worker's professional skill, knowledge, and competence.</text> </paragraph> <paragraph num="B."> <text>Documentation shall be provided for the continuing education units listed in §§C—F of this regulation as set forth in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Continuing Education Unit.</text> <paragraph num="(1)"> <text>In an academic classroom setting in an accredited academic institution, if a course is taken for academic credit, 1 academic credit is equal to 5 continuing education units.</text> </paragraph> <paragraph num="(2)"> <text>In an academic classroom setting in an accredited academic institution, if a course is audited, 1 academic credit is equal to 3 continuing education units.</text> </paragraph> <paragraph num="(3)"> <text>Programs may include the terms “contact hour”, “CEU”, “clock hour”, and “hour” in the description of the course. Any program described with these terms that lasts 60 minutes provides 1 continuing education unit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Category I Activities. Of the 40 (30 for Licensed Bachelor Social Workers) required continuing education units:</text> <paragraph num="(1)"> <text>A minimum of 20 (15 for Licensed Bachelor Social Workers) shall be earned; and</text> </paragraph> <paragraph num="(2)"> <text>All may be earned from one or any combination of the following Category I activities provided by a Board-authorized sponsor:</text> <paragraph num="(a)"> <text>A course including, but not limited to, a series of learning experiences with a specific content and offered for credit, noncredit, or audit by an accredited educational institution;</text> </paragraph> <paragraph num="(b)"> <text>A workshop including, but not limited to, a session designed to bring together individuals around a common theme to solve problems and gain new knowledge, skills, and attitudes, with ample opportunity to interact;</text> </paragraph> <paragraph num="(c)"> <text>A seminar including, but not limited to, a group of social workers who meet under expert leadership or a resource individual who conducts a discussion on a specific topic;</text> </paragraph> <paragraph num="(d)"> <text>A symposium including, but not limited to, a presentation or presentations by professional specialists on a particular subject;</text> </paragraph> <paragraph num="(e)"> <text>A conference including, but not limited to, sessions of 1 or more days duration designed to explore a central theme; and</text> </paragraph> <paragraph num="(f)"> <text>Attendance at programs offered at professional or scientific meetings of local, State, regional, national, and international professional or scientific organizations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Category II Activities. Of the 40 (30 for Licensed Bachelor Social Workers) required continuing education units, a maximum of 20 (15 for Licensed Bachelor Social Workers) continuing education units may be earned from one or any combination of the following Category II activities:</text> <paragraph num="(1)"> <text>Peer case conferences among licensed social workers and licensed health care professionals designed to promote more effective interventions and advanced practice;</text> </paragraph> <paragraph num="(2)"> <text>Journal or clinical book clubs that meet for at least 1 hour and are organized for the purpose of examining the literature and incorporating in the discussion the application of current literature to social work practice;</text> </paragraph> <paragraph num="(3)"> <text>Preparing and presenting approved face-to-face programs of instruction with 1 hour of preparation or presentation equal to 1 continuing education unit up to a maximum of 12 units per license renewal period;</text> </paragraph> <paragraph num="(4)"> <text>Preparing and presenting a scientific or professional paper at a meeting of a professional or scientific organization with 1 hour of preparation or presentation equal to 1 continuing education unit up to a maximum of 12 units per license renewal period;</text> </paragraph> <paragraph num="(5)"> <text>Authoring a professional publication (including peer-reviewed journals, books, and other professional publications) with 1 hour of authoring equal to 1 continuing education unit earned at the time the publication is published up to a maximum of 12 units per license renewal period;</text> </paragraph> <paragraph num="(6)"> <text>Teaching a social work related course in an academic setting up to a maximum of 12 units per license renewal period;</text> </paragraph> <paragraph num="(7)"> <text>Online learning provided by a Board-authorized sponsor, such as:</text> <paragraph num="(a)"> <text>Digital seminar;</text> </paragraph> <paragraph num="(b)"> <text>Webinar, pre-recorded and non-interactive;</text> </paragraph> <paragraph num="(c)"> <text>Online course;</text> </paragraph> <paragraph num="(d)"> <text>Distance learning; and</text> </paragraph> <paragraph num="(e)"> <text>Home study course;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Attending a foreign or sign language course intended to enhance the delivery of social work services up to a maximum of 6 units per license renewal period; and</text> </paragraph> <paragraph num="(9)"> <text>Attending in-service staff development, professional training, and invited in-house speaker sessions including, but not limited to, an educational program planned by an agency to assist employees in becoming knowledgeable of and competent in professional social work practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Authorized Sponsors and Approval of Continuing Education Programs."> <paragraph num="A."> <text>Authorized Sponsors.</text> <paragraph num="(1)"> <text>Authorized sponsors shall offer continuing education programs that meet the objectives set forth in Regulations .01B and .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The following are authorized sponsors:</text> <paragraph num="(a)"> <text>National, regional, or State accredited academic institutions offering academic courses or programs recognized as acceptable social work curriculum subject areas by the Council on Social Work Education;</text> </paragraph> <paragraph num="(b)"> <text>National, regional, or State social work associations including, but not limited to:</text> <paragraph num="(i)"> <text>Social work licensing boards;</text> </paragraph> <paragraph num="(ii)"> <text>The Association of Social Work Boards;</text> </paragraph> <paragraph num="(iii)"> <text>The National Association of Social Workers; and</text> </paragraph> <paragraph num="(iv)"> <text>Non-social-work professional membership organizations providing programs that are relevant to the professional development of social workers;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maryland State or county government entities that have registered using a Board approved form and attested to:</text> <paragraph num="(i)"> <text>Compliance with all requirements set forth in this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Employment of Maryland licensed social workers;</text> </paragraph> <paragraph num="(iii)"> <text>Adherence to the objectives set forth in Regulation .01 of this chapter; and</text> </paragraph> <paragraph num="(iv)"> <text>The administration of all continuing education learning activities as required in Regulation .04 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Maryland nonprofit organizations that:</text> <paragraph num="(i)"> <text>Meet all of the requirements set forth in §A(2)(c) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide the Board with documentation of current nonprofit status; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>International social work associations and accredited academic institutions including, but not limited to:</text> <paragraph num="(i)"> <text>Social work licensing boards which provide programs that foster improvement, advancement, and extension of the social worker’s professional skill, knowledge, and competence; and</text> </paragraph> <paragraph num="(ii)"> <text>Non-social-work organizations providing programs that are relevant to the professional development of social workers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Registration Process. The Board shall issue a notice of authorized sponsor status to a Maryland State or county government entity or Maryland nonprofit organization within 60 days if the applicant:</text> <paragraph num="(a)"> <text>Completes the online Board approved registration form;</text> </paragraph> <paragraph num="(b)"> <text>Submits to the Board all required documentation as set forth in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Meets all of the requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An authorized sponsor shall:</text> <paragraph num="(a)"> <text>Include the following in the program announcement, flyer, or brochure:</text> <paragraph num="(i)"> <text>The date, title, location, objectives, and content of the program;</text> </paragraph> <paragraph num="(ii)"> <text>The number of continuing education units that will be awarded by the sponsor on a certificate awarded to the social worker on completion of the program;</text> </paragraph> <paragraph num="(iii)"> <text>A statement that the named sponsor is authorized by the Board; and</text> </paragraph> <paragraph num="(iv)"> <text>A statement that the named sponsor maintains responsibility for the program;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Ensure that a program certificate or letter of completion on official letterhead is provided and includes the following:</text> <paragraph num="(i)"> <text>The name of the social worker;</text> </paragraph> <paragraph num="(ii)"> <text>The date, title, and location of the program;</text> </paragraph> <paragraph num="(iii)"> <text>The number of continuing education units that are being awarded to the social worker on completion of the program only for actual time in attendance;</text> </paragraph> <paragraph num="(iv)"> <text>An authorizing name, signature, and contact information for the person responsible for awarding the certificate or letter of completion;</text> </paragraph> <paragraph num="(v)"> <text>A statement that the named sponsor is authorized by the Board; and</text> </paragraph> <paragraph num="(vi)"> <text>A statement that the named sponsor maintains responsibility for the program; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain documentation of continuing education activity for 4 years, which may include pretests and post-tests, but shall include:</text> <paragraph num="(i)"> <text>Registration and attendance records;</text> </paragraph> <paragraph num="(ii)"> <text>Stated purpose;</text> </paragraph> <paragraph num="(iii)"> <text>Content of presentation;</text> </paragraph> <paragraph num="(iv)"> <text>Time and length of activity; and</text> </paragraph> <paragraph num="(v)"> <text>Participant evaluations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Board may audit authorized sponsors’ continuing education programs and activities at any time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall establish a committee for continuing education that is responsible for recommending to the Board approval for proposed activities, sponsors, and programs offered by individuals or organizations that come under §A(2) of this regulation.</text> </paragraph> <paragraph num="C."> <text>The Board shall maintain a roster of authorized sponsors.</text> <paragraph num="(1)"> <text>All authorized sponsors shall inform the Board of a change in any of the following within 60 days of the change:</text> <paragraph num="(a)"> <text>Sponsor name;</text> </paragraph> <paragraph num="(b)"> <text>Primary and secondary contacts;</text> </paragraph> <paragraph num="(c)"> <text>Mailing address;</text> </paragraph> <paragraph num="(d)"> <text>Phone number;</text> </paragraph> <paragraph num="(e)"> <text>Email address; and</text> </paragraph> <paragraph num="(f)"> <text>Dissolution or closure of the entity or organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure to notify the Board of a change as set forth under §C(1) of this regulation may result in withdrawal of authorization as a sponsor.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Withdrawal of Authorization as a Sponsor.</text> <paragraph num="(1)"> <text>Authorization as a sponsor may be withdrawn from any authorized sponsor that fails to comply with the:</text> <paragraph num="(a)"> <text>Requirements of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Objectives set forth in Regulation .01 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Criteria set forth in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A sponsor that has had its authorization withdrawn may reapply for authorization by submitting:</text> <paragraph num="(a)"> <text>A written request to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation that the sponsor is in compliance with the requirements and criteria set forth in this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reporting, Documenting, and Auditing Compliance with Continuing Education Requirements."> <paragraph num="A."> <text>A social worker who has completed the continuing education requirements shall attest to that on a form supplied by the Board as part of the application for license renewal, reinstatement, or reactivation.</text> </paragraph> <paragraph num="B."> <text>The Board shall audit a percentage of social workers, to be selected by the Board, for each renewal period.</text> </paragraph> <paragraph num="C."> <text>On request by the Board, a social worker shall provide full documentation of the continuing education units completed in accordance with the requirements of §D of this regulation.</text> </paragraph> <paragraph num="D."> <text>Documentation.</text> <paragraph num="(1)"> <text>A social worker shall provide to the Board:</text> <paragraph num="(a)"> <text>An official transcript for continuing education units earned in a course taken for academic credit;</text> </paragraph> <paragraph num="(b)"> <text>A certificate of completion for approved programs;</text> </paragraph> <paragraph num="(c)"> <text>If a certificate of completion is not available, the following documentation, which may earn Category II continuing education units:</text> <paragraph num="(i)"> <text>Date, location, and proof of attendance of the program presented;</text> </paragraph> <paragraph num="(ii)"> <text>Names and credentials of the presenters;</text> </paragraph> <paragraph num="(iii)"> <text>Agenda, learning objectives, and topics presented; and</text> </paragraph> <paragraph num="(iv)"> <text>An outline of the presentation;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A reprint of the social worker's completed publication;</text> </paragraph> <paragraph num="(e)"> <text>If a certificate of completion is not available for an audiovisual instructional program or a home study course, proof of completion of the program or course, such as a post-test passing score or other satisfactory proof as determined by the Board;</text> </paragraph> <paragraph num="(f)"> <text>Proof of presentations made; and</text> </paragraph> <paragraph num="(g)"> <text>Topics, dates, times, names of participants, location, and continuing education units earned on official letterhead in structured peer-case conferences and journal club activities.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a certificate of completion as required by §D(1) of this regulation is not available, the social worker may not earn Category I continuing education units.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Record Retention for Active, Expired, or Inactive License.</text> <paragraph num="(1)"> <text>Active Licenses.</text> <paragraph num="(a)"> <text>A social worker with an active license shall retain records documenting completion of continuing education requirements for 3 years after the licensing renewal date for which the report of continuing education was submitted to the Board.</text> </paragraph> <paragraph num="(b)"> <text>The documentation required in §E(1)(a) of this regulation may be requested by the Board at any time within that 3-year period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Expired Licenses. An individual who has an expired, non-renewed license shall:</text> <paragraph num="(a)"> <text>Retain records documenting completion of continuing education requirements for the 2 years immediately preceding the submission of an application for reinstatement; and</text> </paragraph> <paragraph num="(b)"> <text>File with the Board documentation of completion of continuing education units at the time of reinstatement .</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Inactive Licenses. An individual who has an inactive license shall:</text> <paragraph num="(a)"> <text>Retain records documenting completion of continuing education requirements for the 2 years immediately preceding the submission of an application for reactivation; and</text> </paragraph> <paragraph num="(b)"> <text>File with the Board documentation of completion of continuing education units at the time of reactivation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Responsibility for Conducting the Audits.</text> <paragraph num="(1)"> <text>The Board staff or the Board’s designee shall:</text> <paragraph num="(a)"> <text>Review and evaluate the documentation submitted for the purpose of the audits;</text> </paragraph> <paragraph num="(b)"> <text>Notify a social worker by electronic mail or first-class mail if continuing education requirements have not been met; and</text> </paragraph> <paragraph num="(c)"> <text>Report the findings to the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may require a social worker to submit a copy of the purpose, objectives, and content areas from the continuing education program.</text> </paragraph> <paragraph num="(3)"> <text>The Board may require a social worker to obtain additional continuing education units if a program is disapproved as a result of a review and evaluation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Consequences of Failure to Comply with Continuing Education Requirements."> <paragraph num="A."> <text>The Board shall take disciplinary action under COMAR 10.42.04 against any social worker who fraudulently attests to or does not submit continuing education documentation.</text> </paragraph> <paragraph num="B."> <text>A social worker who fails to complete the continuing education requirements within the time frame specified under Regulation .03 of this chapter may be subject to informal or formal discipline.</text> </paragraph> <paragraph num="C."> <text>A social worker who fails to meet the continuing education requirements may not be issued a license renewal.</text> </paragraph> <paragraph num="D."> <text>The Board shall notify a social worker by electronic mail and first-class mail that the license has not been renewed if the following has occurred:</text> <paragraph num="(1)"> <text>The Board has not received the required certification of completion of continuing education requirements by October 31 of the renewal year;</text> </paragraph> <paragraph num="(2)"> <text>Continuing education requirements have not been met; or</text> </paragraph> <paragraph num="(3)"> <text>The social worker has not responded to audit requirements within the time required.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall close an application that is not approved after 1 year from date of receipt.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reinstatement of Licenses."> <text>An individual whose license has not been renewed is entitled to reinstatement within 5 years if the following is completed on or before October 31 of the 5th year after the date the license expired:</text> <paragraph num="A."> <text>All required documentation is submitted and approved by the Board;</text> </paragraph> <paragraph num="B."> <text>The reinstatement fee established by the Board is paid, as provided in COMAR 10.42.05.02; and</text> </paragraph> <paragraph num="C."> <text>The individual has met all continuing education requirements by obtaining 40 (30 for Licensed Bachelor Social Workers) continuing education units in the 2 years preceding the individual’s application for reinstatement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reactivation of Licenses."> <text>An individual whose license was placed on inactive status is entitled to reactivation within 5 years if the following is completed on or before October 31 of the 5th year after the date the license was placed on inactive status:</text> <paragraph num="A."> <text>All required documentation is submitted and approved by the Board;</text> </paragraph> <paragraph num="B."> <text>The reactivation fee established by the Board is paid, as provided in COMAR 10.42.05.02; and</text> </paragraph> <paragraph num="C."> <text>The individual has met all continuing education requirements by obtaining 40 (30 for Licensed Bachelor Social Workers) continuing education units in the 2 years preceding the individual’s application for reactivation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Extension of Time."> <paragraph num="A."> <text>An actively licensed social worker may file a request to extend time and conditionally renew a license. The request shall:</text> <paragraph num="(1)"> <text>Be in writing;</text> </paragraph> <paragraph num="(2)"> <text>Include supporting documentation; and</text> </paragraph> <paragraph num="(3)"> <text>Be filed before October 1 of the renewal year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall consider and render a decision on the request within 21 days of receiving the written request.</text> </paragraph> <paragraph num="C."> <text>The Board may grant an extension of time and conditionally renew an active social work license for up to 6 months if the Board determines that:</text> <paragraph num="(1)"> <text>Failure to fulfill the requirements is a result of:</text> <paragraph num="(a)"> <text>Functional impairment or prolonged illness that has been diagnosed by a health care practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Mandatory military service or deployment;</text> </paragraph> <paragraph num="(c)"> <text>A prolonged absence from the United States;</text> </paragraph> <paragraph num="(d)"> <text>An officially declared State of Emergency or disaster; or</text> </paragraph> <paragraph num="(e)"> <text>Financial hardship; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The social worker attempted to meet the continuing education requirements.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Failure of a social worker with an active license to obtain the required continuing education units on or before the 6-month extension expires shall result in:</text> <paragraph num="(1)"> <text>The expiration of the license;</text> </paragraph> <paragraph num="(2)"> <text>The social worker’s inability to practice social work in Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>The Board placing the license on non-renewed status.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Continuing education hours earned after October 31 of the second year to fulfill the conditions of an extension may only be credited to the preceding 2-year period.</text> </paragraph> <paragraph num="F."> <text>The Board shall audit a social worker who has been granted an extension of time under this regulation for the completion of continuing education requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Exceptions from Certain Requirements."> <paragraph num="A."> <text>Before attending a program, a social worker with an active license requesting an exception from certain requirements of this chapter shall provide:</text> <paragraph num="(1)"> <text>Official documentation that confirms circumstances beyond the control of the social worker because of:</text> <paragraph num="(a)"> <text>A functional impairment or prolonged illness that has been diagnosed by a health care practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Mandatory military service or deployment;</text> </paragraph> <paragraph num="(c)"> <text>A prolonged absence from the United States;</text> </paragraph> <paragraph num="(d)"> <text>An officially declared State of Emergency or disaster; or</text> </paragraph> <paragraph num="(e)"> <text>Financial hardship;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Documentation that describes the continuing education programs selected by the social worker considered equivalent to continuing education activities described in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>An acceptable procedure for documenting the continuing education units.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall audit an actively licensed social worker who has been granted an exception from the continuing education requirements.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-101(b) and (j), 19-205 and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective March 22, 1994 (21:8 Md. R. 666); adopted permanently effective September 12, 1994 (21:18 Md. R. 1509)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 12, 1996 (23:16 Md. R. 1176)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed and new Regulations .01—.12 adopted effective November 1, 2003 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed and Regulation .12 recodified to be Regulation .11 effective January 1, 2007 (33:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed and new Regulations .01—.11 adopted effective March 22, 2010 (37:6 Md. R. 478)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228); July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, E amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); amended permanently effective September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective December 11, 2023 (50:24 Md. R. 1042); April 28, 2025 (52:8 Md. R. 358)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 11, 2023 (50:24 Md. R. 1042); April 28, 2025 (52:8 Md. R. 358)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 11, 2023 (50:24 Md. R. 1042)</annotation> </annotations> </chapter> <chapter num="07" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The custodian of the records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, and may disclose the information if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to that information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the custodian of the records reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prohibit or limit the ability of the Board to disclose general licensing information under General Provisions Article, §4-333, Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §19-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 1, 2002 (29:6 Md. R. 568)</annotation> </annotations> </chapter> <chapter num="08" heading="Supervision"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes qualifications and standards for independent practice, supervision and the responsibilities of supervisors and supervisees in the practice of social work.</text> </paragraph> <paragraph num="B."> <text>This chapter applies to licensees who practice social work in this State, and individuals applying for licensure to practice social work in this State.</text> </paragraph> <paragraph num="C."> <text>Except as otherwise specified in this chapter, this chapter does not apply to personnel or management practices associated with employment or contractual relationships.</text> </paragraph> <paragraph num="D."> <text>Nothing in this chapter may be construed to prohibit an:</text> <paragraph num="(1)"> <text>Employer from requiring supervision of a licensed bachelor social worker (LBSW), licensed certified social worker (LCSW), licensed certified social worker-clinical (LCSW-C), or licensed master social worker (LMSW) who is approved to engage in independent practice; or</text> </paragraph> <paragraph num="(2)"> <text>LBSW independent practitioner, LMSW independent practitioner, LCSW, or LCSW-C from providing supervision to licensed social work employees who are not pursuing advanced licensure or independent practitioner designation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Agency” means an entity that employs three or more licensees and for which the licensees practice social work.</text> </paragraph> <paragraph num="(2)"> <text>“Board-approved supervisor” means an LBSW, LCSW, LCSW-C, or LMSW approved by the Board to supervise social workers as set forth in this chapter.</text> </paragraph> <paragraph num="(3)"> <text>Face-to-Face.</text> <paragraph num="(a)"> <text>“Face-to-face” means in the physical presence of or electronic presence of the individuals involved in the supervisory relationship during either individual or group supervision.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face” includes:</text> <paragraph num="(i)"> <text>Secure video conferencing; or</text> </paragraph> <paragraph num="(ii)"> <text>Real-time communication with both parties in each other’s physical presence.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Face-to-face” does not include:</text> <paragraph num="(i)"> <text>Telephone supervision;</text> </paragraph> <paragraph num="(ii)"> <text>Written communication via the internet; or</text> </paragraph> <paragraph num="(iii)"> <text>Technological communication that is not visual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Independent practice” means to practice bachelor social work or master social work without the requirement of supervision by a social worker.</text> </paragraph> <paragraph num="(5)"> <text>“Relative” means a:</text> <paragraph num="(a)"> <text>Spouse;</text> </paragraph> <paragraph num="(b)"> <text>Parent or stepparent;</text> </paragraph> <paragraph num="(c)"> <text>Sibling or stepsibling;</text> </paragraph> <paragraph num="(d)"> <text>Child, stepchild, foster child, or ward;</text> </paragraph> <paragraph num="(e)"> <text>Mother-in-law or father-in-law;</text> </paragraph> <paragraph num="(f)"> <text>Son-in-law or daughter-in-law;</text> </paragraph> <paragraph num="(g)"> <text>Grandparent;</text> </paragraph> <paragraph num="(h)"> <text>Grandchild;</text> </paragraph> <paragraph num="(i)"> <text>Aunt; or</text> </paragraph> <paragraph num="(j)"> <text>Uncle.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee in which the supervisor directs, monitors, and evaluates the supervisee's social work practice while promoting development of the supervisee's knowledge, skills, and abilities to provide social work services in an ethical and competent manner.</text> </paragraph> <paragraph num="(7)"> <text>“Supervision training” means a course or program designed to provide information regarding the supervision process utilized by social workers in a variety of settings as set forth in Regulation .04B(1) of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Written contract” for advanced licensure or independent practice means an agreement, on a form provided by the Board and initiated before beginning supervision, between the supervisee, the Board-approved supervisor and administrator that details the scope of supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for a Board-Approved Social Work Supervisor."> <paragraph num="A."> <text>A social worker who intends to provide supervision to a licensed social worker for independent practice:</text> <paragraph num="(1)"> <text>Shall apply to the Board for approval as a Board-approved supervisor; and</text> </paragraph> <paragraph num="(2)"> <text>May continue to provide supervision without Board approval until January 1, 2021.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A social work supervisor of a licensed social worker who is pursuing advanced licensure shall be Board approved prior to commencing supervision.</text> </paragraph> <paragraph num="C."> <text>Licensed Bachelor Social Worker.</text> <paragraph num="(1)"> <text>The Board shall approve an application filed by an LBSW to be a Board-approved supervisor that met the requirements set forth in this regulation and in accordance with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The LBSW applicant for a Board-approved supervisor shall:</text> <paragraph num="(a)"> <text>Obtain independent status in accordance with COMAR 10.42.02.05;</text> </paragraph> <paragraph num="(b)"> <text>Obtain the additional hours of experience as an LBSW in accordance with Regulation .04C(4) of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>File with the Board the supervisory registration form and pay the required fee;</text> </paragraph> <paragraph num="(d)"> <text>Have a license that is unencumbered and without restrictions or conditions due to a disciplinary action for the 5 years preceding application for supervisor status;</text> </paragraph> <paragraph num="(e)"> <text>Meet the training requirement as set forth in Regulation .04B(1) of this chapter; and</text> </paragraph> <paragraph num="(f)"> <text>Be approved as a supervisor by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A bachelor social work supervisor may not supervise a licensed social worker pursuing advanced licensure.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Licensed Master Social Worker.</text> <paragraph num="(1)"> <text>The Board shall approve an application filed by an LMSW to be a Board-approved supervisor that met the requirements set forth in this regulation and in accordance with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The LMSW applicant for a Board-approved supervisor shall:</text> <paragraph num="(a)"> <text>Obtain independent status in accordance with COMAR 10.42.02.05;</text> </paragraph> <paragraph num="(b)"> <text>Obtain the additional hours of experience as an LMSW in accordance with COMAR 10.42.02.</text> </paragraph> <paragraph num="(c)"> <text>File with the Board the supervisory registration form and pay the required fee;</text> </paragraph> <paragraph num="(d)"> <text>Have a license that is unencumbered and without restrictions or conditions due to a disciplinary action for the 5 years preceding application for supervisor status;</text> </paragraph> <paragraph num="(e)"> <text>Meet the training requirement as set forth in Regulation .04B(1) of this chapter; and</text> </paragraph> <paragraph num="(f)"> <text>Be approved as a supervisor by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An LMSW supervisor may not supervise a licensed social worker pursuing advanced licensure.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Licensed Certified Social Worker.</text> <paragraph num="(1)"> <text>The Board shall approve an application filed by an LCSW to be a Board-approved supervisor that met the requirements set forth in this regulation and in accordance with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The LCSW applicant for Board-approved supervisor shall:</text> <paragraph num="(a)"> <text>Obtain 18 months of active social work experience after obtaining the certified license;</text> </paragraph> <paragraph num="(b)"> <text>File with the Board the supervisory form and pay the required fee;</text> </paragraph> <paragraph num="(c)"> <text>Have a license that is unencumbered and without restrictions or conditions due to a disciplinary action for the 5 years preceding application for supervisor status;</text> </paragraph> <paragraph num="(d)"> <text>Meet the training requirement as set forth in Regulation .04B(1) of this chapter; and</text> </paragraph> <paragraph num="(e)"> <text>Be approved as a supervisor by the Board.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An LCSW supervisor may not supervise an LCSW pursuing advanced clinical licensure.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Licensed Certified Social Worker-Clinical.</text> <paragraph num="(1)"> <text>The Board shall approve an application filed by an LCSW-C to be a Board-approved supervisor that met the requirements set forth in this regulation and in accordance with Regulations .04 and .05 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The LCSW-C applicant for Board-approved supervisor shall:</text> <paragraph num="(a)"> <text>Obtain 18 months of active social work experience after obtaining the certified license;</text> </paragraph> <paragraph num="(b)"> <text>File with the Board the supervisory form and pay the required fee;</text> </paragraph> <paragraph num="(c)"> <text>Have a license that is unencumbered and without restrictions or conditions due to a disciplinary action for the 5 years preceding application for supervisor status;</text> </paragraph> <paragraph num="(d)"> <text>Meet the training requirement as set forth in Regulation .04B(1) of this chapter; and</text> </paragraph> <paragraph num="(e)"> <text>Be approved as a supervisor by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for a Board-Approved Supervisor."> <paragraph num="A."> <text>License.</text> <paragraph num="(1)"> <text>For social workers licensed by the Maryland Board of Social Work Examiners a supervisor shall hold an active license as a:</text> <paragraph num="(a)"> <text>Bachelor Social Worker (LBSW);</text> </paragraph> <paragraph num="(b)"> <text>Certified Social Worker (LCSW);</text> </paragraph> <paragraph num="(c)"> <text>Certified Social Worker-Clinical (LCSW-C); or</text> </paragraph> <paragraph num="(d)"> <text>Masters social worker (LMSW).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For social workers licensed by an out-of-State licensing board, a supervisor shall hold an active license comparable to the:</text> <paragraph num="(a)"> <text>Bachelor Social Worker (LBSW);</text> </paragraph> <paragraph num="(b)"> <text>Certified Social Worker (LCSW);</text> </paragraph> <paragraph num="(c)"> <text>Certified Social Worker-Clinical (LCSW-C); or</text> </paragraph> <paragraph num="(d)"> <text>Masters social worker (LMSW).</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Education.</text> <paragraph num="(1)"> <text>Social workers licensed by the Maryland Board of Social Work shall have:</text> <paragraph num="(a)"> <text>One social work graduate course in supervision from a master's degree program accredited by the Council on Social Work Education;</text> </paragraph> <paragraph num="(b)"> <text>12 hours of agency-sponsored supervision training; or</text> </paragraph> <paragraph num="(c)"> <text>12 credit hours of continuing education in social work supervision by a Board-authorized sponsor.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Social workers licensed as social workers by an out-of-State licensing Board at a level comparable to the LBSW, LCSW, LCSW-C, or LMSW shall:</text> <paragraph num="(a)"> <text>Have the same qualifications under §A(2)(a) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Complete the education requirement within 12 months of obtaining a Maryland LBSW, LCSW, LCSW-C, or LMSW.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Supervision training required in Regulation .04B(1) of this chapter shall be obtained in Category I or Category II and may include, but is not limited to:</text> <paragraph num="(a)"> <text>The role and responsibilities of the social work supervisor;</text> </paragraph> <paragraph num="(b)"> <text>The needs of the supervisee, supervisor, and the agency setting while maintaining a clear ethical perspective;</text> </paragraph> <paragraph num="(c)"> <text>The role of the social work supervisor as gatekeeper to the profession;</text> </paragraph> <paragraph num="(d)"> <text>Methods for building effective and appropriate relationships with clients;</text> </paragraph> <paragraph num="(e)"> <text>Methods for group supervision; and</text> </paragraph> <paragraph num="(f)"> <text>Models and modalities for practice intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Experience. A supervisor shall have completed:</text> <paragraph num="(1)"> <text>18 months of active social work experience after obtaining an LCSW or LCSW-C;</text> </paragraph> <paragraph num="(2)"> <text>18 months of active social work experience a s a social worker licensed by an out-of-State licensing board at a level comparable to the LCSW or LCSW-C;</text> </paragraph> <paragraph num="(3)"> <text>24 months of social work experience as an independent licensed master social worker or its equivalent before obtaining an the LCSW or LCSW-C license or 60 months of social work experience as an LMSW or its equivalent before obtaining an LCSW or LCSW-C license; or</text> </paragraph> <paragraph num="(4)"> <text>24 months of social work experience as an independent licensed bachelor social worker or its equivalent before obtaining the LCSW or LCSW-C license or 60 months of social work experience as an LBSW or its equivalent before obtaining an LCSW or LCSW-C license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration."> <paragraph num="A."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Have filed with the Board the form designated as the supervisory registration form;</text> </paragraph> <paragraph num="(2)"> <text>Have a license that is unencumbered and without restrictions or conditions due to disciplinary action for the 5 years preceding supervisor status;</text> </paragraph> <paragraph num="(3)"> <text>Have been approved as a supervisor by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Have established and maintained a written contract, on a form provided by the Board prior to initiating supervision for advanced licensure and independent practice in order to provide supervision with the supervisee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisor shall be:</text> <paragraph num="(1)"> <text>An agency-designated supervisor; or</text> </paragraph> <paragraph num="(2)"> <text>An independent supervisor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standards for Supervision."> <paragraph num="A."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Supervise only in those areas within the supervisor's competence as determined by education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision appropriate to the particular level of licensure being applied for or maintained;</text> </paragraph> <paragraph num="(3)"> <text>Instruct and provide role modeling in the general content areas established in Health Occupations Article, §19-101(m), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that a supervisee has read and is knowledgeable about Health Occupations Article, Title 19, Annotated Code of Maryland, and COMAR 10.42.01—10.42.08.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, the supervisor shall specifically instruct and provide guidance relating to the supervisee's scope of practice of social work under Health Occupations Article, §§19-301 and 19-307, Annotated Code of Maryland, including:</text> <paragraph num="(1)"> <text>Developing skill in recognition of patterns of behavior, based on clients' or patients' capacities and deficits;</text> </paragraph> <paragraph num="(2)"> <text>Understanding and recognizing issues of the helping relationship;</text> </paragraph> <paragraph num="(3)"> <text>Maintaining client or patient confidentiality with respect to privileged communications;</text> </paragraph> <paragraph num="(4)"> <text>Defining boundaries;</text> </paragraph> <paragraph num="(5)"> <text>Setting limits;</text> </paragraph> <paragraph num="(6)"> <text>Recognition of cultural diversity;</text> </paragraph> <paragraph num="(7)"> <text>Assessing the client for risk of imminent danger;</text> </paragraph> <paragraph num="(8)"> <text>Administrative skills;</text> </paragraph> <paragraph num="(9)"> <text>Supervision; and</text> </paragraph> <paragraph num="(10)"> <text>Documentation and record keeping requirements as set forth in Health-General Article, Title 4, Annotated Code of Maryland, and in accordance with COMAR 10.42.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Supervision of Candidates for a Certified Social Worker—Clinical License. In addition to the other requirements of this regulation, the supervisor of a certified social worker-clinical candidate shall instruct and provide guidance in:</text> <paragraph num="(1)"> <text>Appropriate billing practices if applicable to the practice site, including:</text> <paragraph num="(a)"> <text>Establishment and disclosure to clients of:</text> <paragraph num="(i)"> <text>Fees for services;</text> </paragraph> <paragraph num="(ii)"> <text>Payment arrangements;</text> </paragraph> <paragraph num="(iii)"> <text>Payment plans;</text> </paragraph> <paragraph num="(iv)"> <text>Financing services; and</text> </paragraph> <paragraph num="(v)"> <text>Terms and conditions of service;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Financial record keeping and disclosure; and</text> </paragraph> <paragraph num="(c)"> <text>Documentation and record keeping requirements as set forth in Health-General Article, Title 4, Annotated Code of Maryland, and in accordance with COMAR 10.42.03.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Treatment of mental disorders and other conditions; and</text> </paragraph> <paragraph num="(3)"> <text>The provision of psychotherapy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A relative may not provide supervision for a social worker.</text> </paragraph> <paragraph num="E."> <text>A licensed master social worker in independent practice may provide supervision for bachelor or master social workers under the terms and conditions set forth in Regulations .04 and .05 of this chapter and in accordance with COMAR 10.42.02.</text> </paragraph> <paragraph num="F."> <text>A licensed bachelor social worker may provide supervision for bachelor social workers under the terms and conditions set forth in Regulations .04 and .05 of this chapter and in accordance with COMAR 10.42.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Responsibilities of a Supervisor."> <paragraph num="A."> <text>A social work supervisor shall be Board-approved before providing supervision to licensed social workers for advanced practice or independent practice.</text> </paragraph> <paragraph num="B."> <text>A Board-approved supervisor shall remain knowledgeable of the statutes and regulations as set forth in Health Occupations Article, Title 19, Annotated Code of Maryland and COMAR 10.42.01—10.42.09.</text> </paragraph> <paragraph num="C."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Ensure that a supervisee is practicing within the scope of the supervisee's license;</text> </paragraph> <paragraph num="(2)"> <text>Determine the skill level at which the supervisee may practice;</text> </paragraph> <paragraph num="(3)"> <text>Focus on raw data from the supervisee's social work practice;</text> </paragraph> <paragraph num="(4)"> <text>Maintain documentation, for at least 5 years, of the supervisory sessions, including the dates, duration, and focus of the supervisory sessions;</text> </paragraph> <paragraph num="(5)"> <text>Provide or ensure that a supervisee receives a minimum of 3 hours of face-to-face supervision per month or 1 hour of face-to-face supervision for every 40 hours worked;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that a supervisee has read and is knowledgeable about Health Occupations Article, Title 19, Annotated Code of Maryland, and COMAR 10.42.01—10.42.09;</text> </paragraph> <paragraph num="(7)"> <text>Within a reasonable period of time before termination of supervision, provide the supervisee and employer with a notice of termination to avoid or minimize any harmful effect on the supervisee's clients or patients;</text> </paragraph> <paragraph num="(8)"> <text>At the time of license renewal, demonstrate to the Board completion of 3 of the required Category I or Category II continuing education units in a content area focusing on supervision training as stipulated in Regulation .04A(2)(c) of this chapter;</text> </paragraph> <paragraph num="(9)"> <text>Establish a written contract, on the form provided by the Board, for advanced licensure or independent practice, initiated before beginning supervision;</text> </paragraph> <paragraph num="(10)"> <text>Provide for emergency supervision and direction to a supervisee by a Board-approved supervisor;</text> </paragraph> <paragraph num="(11)"> <text>Complete the supervision verification form;</text> </paragraph> <paragraph num="(12)"> <text>Provide a written evaluation of the supervisee's progress to the supervisee every 6 months;</text> </paragraph> <paragraph num="(13)"> <text>Provide a copy of the documentation required by Regulation .04 of this chapter:</text> <paragraph num="(a)"> <text>On request by the supervisee; and</text> </paragraph> <paragraph num="(b)"> <text>On request, by the Board or its authorized agent; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Comply with a Board audit of a supervisor's compliance with regard to the supervision requirements and supervisory responsibilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Responsibilities of a Supervisee."> <paragraph num="A."> <text>A supervisee shall:</text> <paragraph num="(1)"> <text>Receive social work supervision for social work practice as set forth in Health Occupations Article, §19-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Receive a minimum of 3 hours of face-to-face supervision per month or 1 hour of face-to-face supervision for every 40 hours worked;</text> </paragraph> <paragraph num="(3)"> <text>Prepare for supervision using case materials related to the supervisee's social work practice;</text> </paragraph> <paragraph num="(4)"> <text>Maintain documentation, for at least 5 years, of the supervisory sessions, including the dates, duration, and focus of the supervisory sessions;</text> </paragraph> <paragraph num="(5)"> <text>Establish a written contract, on a form provided by the Board, for advanced licensure or independent practice, initiated before beginning supervision; and</text> </paragraph> <paragraph num="(6)"> <text>Attend and participate in supervision as agreed upon in the written contract for advanced licensure or independent practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisee may contract for supervision outside of the employment setting as approved by the agency administrator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Group Supervision for Advanced Licensure."> <paragraph num="A."> <text>Group supervision is an optional form of supervision and may not be used as the sole form of supervision.</text> </paragraph> <paragraph num="B."> <text>Only half of the required hours of supervision may be obtained from group supervision.</text> </paragraph> <paragraph num="C."> <text>The group supervisor shall provide supervision to not more than six supervisees at any time.</text> </paragraph> <paragraph num="D."> <text>A group supervisor shall comply with the requirements of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Status of Independent Practice."> <text>The Board shall maintain an indication that the licensee is approved for independent practice on its roster of licensees on the web site.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Status of Board-Approved Supervisor."> <text>The Board shall maintain an indication that the licensee is a Board-approved supervisor on its roster of licensees on the web site.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§19-101—19-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2004 (30:23 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective September 13, 2004 (31:18 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective July 19, 2004 (31:14 Md. R. 1078)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 17, 2007 (34:25 Md. R. 2211)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 31, 2017 (44:15 Md. R. 760)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 17, 2019 (46:12 Md. R. 544)</annotation> </annotations> </chapter> <chapter num="09" heading="Disciplinary Sanctions and Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for sanctions and monetary penalties not exceeding $10,000 against any social worker in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §19-311.1, Annotated Code of Maryland, to impose a sanction or monetary penalty.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Social Work Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“License” means a license issued by the Board to practice social work.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means a social worker who is licensed by the Board to practice social work.</text> </paragraph> <paragraph num="(4)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(5)"> <text>“Sanction” means a formal disciplinary action against a license such as a reprimand, probation, suspension or revocation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty after a Hearing."> <text>If, after a hearing under Health Occupations Article, §19-312, Annotated Code of Maryland, the Board finds that there are grounds under Health Occupations Article, §19-311, Annotated Code of Maryland, to suspend or revoke a license, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="A."> <text>Instead of, or in addition to, suspending the license; or</text> </paragraph> <paragraph num="B."> <text>In addition to revoking the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions and Imposition of Penalties."> <paragraph num="A."> <text>Subject to the provisions of this section, the Board may impose sanctions and penalties for violations of the Maryland Social Workers Act, Health Occupations Article, §19-311, Annotated Code of Maryland, and according to the guidelines set forth in the following chart:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this chapter, the category or categories containing the highest maximum sanction and penalty shall prevail.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or a consent order with terms, sanction, and penalty agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="D."> <text>A departure from the guidelines set forth in this chapter alone is not grounds for any hearing or appeal of a Board action.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to be Considered in the Assessment of the Sanction."> <text>Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="A."> <text>Mitigating Factors:</text> <paragraph num="(1)"> <text>The licensee’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The licensee self-reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The licensee’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>Timely good-faith effort to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm to public or adverse impact; and</text> </paragraph> <paragraph num="(9)"> <text>The licensee’s conduct was an isolated incident and not likely to recur.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating Factors:</text> <paragraph num="(1)"> <text>The licensee has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the clients;</text> </paragraph> <paragraph num="(7)"> <text>The licensee lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(8)"> <text>The licensee committed the violation under the guise of treatment; and</text> </paragraph> <paragraph num="(9)"> <text>Previous attempts at rehabilitation of the licensee were unsuccessful.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="D."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of Penalty."> <paragraph num="A."> <text>A licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §19-313, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter into the State's General Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Civil Fines."> <paragraph num="A."> <text>The Board may impose a civil fine of no less than $1,000 and no more than $50,000 against an individual who:</text> <paragraph num="(1)"> <text>Practices social work without a license in violation of Health Occupations Article, §19-311, Annotated Code of Maryland: or</text> </paragraph> <paragraph num="(2)"> <text>Misrepresents or implies to the public use of protected titles in violation of Health Occupations Article, §19-402, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Factors to be used in determining the amount of the fine may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>The extent to which the individual derived any financial benefit from the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(2)"> <text>The willfulness of the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(3)"> <text>Actual or potential harm caused by the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(4)"> <text>The cost of the investigation; and</text> </paragraph> <paragraph num="(5)"> <text>The length of time in which the individual engaged in the unauthorized practice or misrepresentation of title.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§19-311 and 19-311.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 19, 2012 (39:5 Md. R. 383)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 17, 2019 (46:12 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective June 17, 2019 (46:12 Md. R. 544)</annotation> </annotations> </chapter> <chapter num="10" heading="Teletherapy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of social work using teletherapy as an adjunct to, or replacement for, in-person client visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to the Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Social Work Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Client” means the individual, couple, family, group, business, agency, school, organization, or association that the licensed social worker provides, or has provided, with professional services.</text> </paragraph> <paragraph num="(4)"> <text>“In-person” means within the physical presence of the client.</text> </paragraph> <paragraph num="(5)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(6)"> <text>“Teletherapy” means telehealth as defined in Health Occupations Article, §1-901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Teletherapy practitioner” means a Maryland licensed social worker performing teletherapy services within their respective scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, Title 19, Subtitle 3, Annotated Code of Maryland, in order to practice teletherapy a teletherapy practitioner shall be licensed in Maryland when providing teletherapy services to a client located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Teletherapy."> <paragraph num="A."> <text>Before providing teletherapy services, a teletherapy practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the client receiving teletherapy services through the use of:</text> <paragraph num="(a)"> <text>A government issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the client’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial client-telehealth practitioner encounter, disclose the teletherapy practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license number and type; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written informed consent from a client or a client’s parent or guardian if State law requires the consent of a parent or guardian, including informing clients of the risks, opportunities, and obligations associated with services available to the client;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a client’s clinical data and self-reported medical history, as necessary, and prevent access to data by unauthorized persons through encryption, or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify clients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the teletherapy practitioner provides a secure and private communication modality and complies with federal and State privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous teletherapy services, a teletherapy practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the client is in Maryland and identify the client’s specific location; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are permitted to hear the client’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A teletherapy practitioner shall be held to the same standards of practice and documentation as those applicable for in-person social work practice sessions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Client Evaluation."> <paragraph num="A."> <text>A teletherapy practitioner shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical client evaluation that is appropriate for the client and the condition with which the client presents before providing treatment or services through teletherapy; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the client, provide or refer a client to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of teletherapy service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A teletherapy practitioner may not treat a client based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Teletherapy Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards in evaluating and investigating a complaint and disciplining a licensee who practices teletherapy as it would use for a licensee who does not use teletherapy technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a teletherapy practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-141.2; Health Occupations Article, §§1-901—1-903 and 1-1001— 1-1006; Insurance Article, §15-139, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 7, 2019 (46:20 Md. R. 844)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective September 18, 2023 (50:18 Md. R. 797)</annotation> </annotations> </chapter> </subtitle> <subtitle num="43" heading="Board of Chiropractic Examiners"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Rules of Order."> <text>All proceedings of the Board in regular session shall be governed by Robert's Rules of Order.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Board Officers, Members, and Staff."> <paragraph num="A."> <text>The Board shall, as the appointing authority, direct the operation of the staff through the executive director.</text> </paragraph> <paragraph num="B."> <text>Board members may not have monetary, pecuniary, or other interest in the affairs of any:</text> <paragraph num="(1)"> <text>Staff member; or</text> </paragraph> <paragraph num="(2)"> <text>Organization engaged in business with the Board, including:</text> <paragraph num="(a)"> <text>Businesses;</text> </paragraph> <paragraph num="(b)"> <text>Enterprises; or</text> </paragraph> <paragraph num="(c)"> <text>Other for-profit organizations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A Board member or Board staff may not serve for compensation as an instructor in a continuing education course or program under Board cognizance over which that Board member or staff member serves in an approval capacity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Preliminary Educational Qualifications Credits."> <text>Preliminary educational qualifications credits acceptable to the Board are:</text> <paragraph num="A."> <text>Certificates or diplomas issued by public and private high schools accredited by the National Council of Secondary Educational Institutions or as recognized by the state or city issuing them.</text> </paragraph> <paragraph num="B."> <text>Certificates issued by the department of education of the states and possessions of the United States to applicants having 15 or more units to their credit.</text> </paragraph> <paragraph num="C."> <text>Applicants presenting foreign credits of preliminary education shall have them certified by the consul or the embassy of the country in which they were acquired.</text> </paragraph> <paragraph num="D."> <text>Bachelor's degree accredited by the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Examination Requirements."> <paragraph num="A."> <text>The Board shall accept examination results only from the National Board of Chiropractic Examiners for applicants for a chiropractic license, including applicants seeking to practice chiropractic with physical therapy privileges.</text> </paragraph> <paragraph num="B."> <text>The Board shall set the minimum passing score for each section of the National Board of Chiropractic Examiners' examination.</text> </paragraph> <paragraph num="C."> <text>The Board shall administer a jurisprudence examination at least twice a year at times and places to be announced by the Board.</text> </paragraph> <paragraph num="D."> <text>An applicant for the jurisprudence examination shall:</text> <paragraph num="(1)"> <text>Have first successfully completed all required parts of the National Board of Chiropractic examination to the satisfaction of the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Submit all documentation and fees at least 45 days before the examination date as determined by postmark.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The examination shall begin promptly at a time announced by the Board and shall be proctored by a Board member or Board staff member.</text> </paragraph> <paragraph num="F."> <text>The applicant shall present a letter of admission and at least one form of personal, valid, current, U.S. government or state issued photo identification. There is no excuse, waiver, or exception for this requirement.</text> </paragraph> <paragraph num="G."> <text>The application shall be executed, verified, and submitted to the Board at least 45 days before the date of examination.</text> </paragraph> <paragraph num="H."> <text>The applicant shall follow all directions of the examination proctor.</text> </paragraph> <paragraph num="I."> <text>The examination paper shall be retained by the Board as follows:</text> <paragraph num="(1)"> <text>Passing examination papers shall be retained for 30 days;</text> </paragraph> <paragraph num="(2)"> <text>Failing examination papers shall be retained for 90 days;</text> </paragraph> <paragraph num="(3)"> <text>All examination papers shall be destroyed after the expiration of the time periods established under §I(1) and (2) of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Retained examination papers may not be reviewed by the applicant following the completion of the applicant's examination.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Board shall administer the jurisprudence examination in the English language with no provisions made by the Board to accommodate the examination in any foreign language.</text> </paragraph> <paragraph num="K."> <text>An applicant who fails the jurisprudence examination three times may not retake the examination until the Board has reviewed the applicant's file and approved a retake.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licenses."> <paragraph num="A."> <text>Temporary Licenses. The Board may not issue any temporary license to practice chiropractic in Maryland.</text> </paragraph> <paragraph num="B."> <text>An individual practicing chiropractic without a license shall be prosecuted and subject to penalties as prescribed in Health Occupations Article, Title 3, Subtitle 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Board shall issue a license only upon an applicant's successful completion of the:</text> <paragraph num="(1)"> <text>National Board of Chiropractic Examiners' examination, Parts I, II, III, and IV;</text> </paragraph> <paragraph num="(2)"> <text>Jurisprudence examination; and</text> </paragraph> <paragraph num="(3)"> <text>National Board of Chiropractic Examiners' Physiotherapy examination, if applicable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may waive educational or examination requirements for any licensed chiropractor applying to practice exclusively with a visiting organization for not more than 30 days per calendar year if the:</text> <paragraph num="(1)"> <text>Chiropractor practices in a Board-approved, recognized jurisdiction with an active license in good standing;</text> </paragraph> <paragraph num="(2)"> <text>Practice is limited exclusively to members of the visiting organization; and</text> </paragraph> <paragraph num="(3)"> <text>Chiropractor submits a timely request by application in accordance with Board procedures.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Display of License in Office. A license holder shall display conspicuously at all times at the license holders' place of business the license granted by the Board.</text> </paragraph> <paragraph num="F."> <text>The license holder shall notify the Board of any change in the name or address of the license holder, in writing, within 60 days after the change occurs.</text> </paragraph> <paragraph num="G."> <text>Licensure by Credential.</text> <paragraph num="(1)"> <text>An application for licensure by credential shall be based on a written SPEC examination administered by the National Board of Chiropractic Examiners, a jurisprudence examination administered by the Board, and the education and professional qualifications of the applicant.</text> </paragraph> <paragraph num="(2)"> <text>At the Board's discretion, an applicant for licensure by credential shall appear before the Board in person before the license is granted.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Renewals.</text> <paragraph num="(1)"> <text>A license holder failing to renew a license shall:</text> <paragraph num="(a)"> <text>Be notified by the Board by certified mail of the delinquency; and</text> </paragraph> <paragraph num="(b)"> <text>Have the license lapse into non-renewed status if the license holder does not renew by September 30th of the renewal year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Continuing Education.</text> <paragraph num="(a)"> <text>Upon renewal, when audited by the Board, a license holder shall submit written evidence of the successful completion of the number of continuing education hours and cardiopulmonary resuscitation (CPR) certification required by the Board for renewal.</text> </paragraph> <paragraph num="(b)"> <text>The license holder shall have completed the required credit hours by the time of renewal.</text> </paragraph> <paragraph num="(c)"> <text>This evidence may include a photocopy of the official transcript or a report of the completion of the course.</text> </paragraph> <paragraph num="(d)"> <text>Only a course program approved by the Board may be used to meet the continuing education requirement of §H(2) of this regulation.</text> </paragraph> <paragraph num="(e)"> <text>The requirement may be waived by the Board upon proof of unusual and extreme hardship or disability, and upon application to the Board at least 60 days before September 1.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Reinstatements. An applicant for reinstatement of a license that has lapsed for a period of more than 2 years shall be admitted only after satisfying the Board as to the applicant's efficiency by examination and the payment of fees due.</text> </paragraph> <paragraph num="J."> <text>Types of Licenses.</text> <paragraph num="(1)"> <text>The Board shall issue two types of licenses:</text> <paragraph num="(a)"> <text>A license covering the practice of chiropractic and physical therapy, as defined in Health Occupations Article, §3-101(f) and (g), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>A license permitting the holder to practice chiropractic as defined in Health Occupations Article, §3-101(f) and (g), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual holding the chiropractic license and wishing to qualify for the license to practice physical therapy in conjunction with a practice of chiropractic may do so by passing the National Board of Chiropractic Examiners Physiotherapy examination with a minimum score of 75 percent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disclosure for Compelling Public Purpose."> <paragraph num="A."> <text>The Board may find that a compelling public purpose warrants disclosure of information in an application, certification, licensing, or investigative file, regardless of whether there has been a request for the information, if:</text> <paragraph num="(1)"> <text>The information concerns possible criminal activity and the disclosure is to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="(2)"> <text>The information concerns a possible violation of law and the disclosure is to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="(3)"> <text>The information concerns conduct by an individual that the Board reasonably believes may pose a risk to the public health, safety, or welfare, and the disclosure is to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Other Disclosures. This regulation does not prohibit or limit the Board's ability to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, Title 3, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 1, 1969</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted as an emergency provision effective November 25, 1985 (12:25 Md. R. 2469); emergency status expired May 24, 1986 (Emergency provisions are temporary and not printed in COMAR)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 21, 1991 (18:1 Md. R. 30)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective April 27, 1977 (4:9 Md. R. 719)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 22, 2007 (34:21 Md. R. 1915); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Subtitle and Chapter name amended to be, Board of Chiropractic Examiners, General Regulations, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="02" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all contested case hearings before the Board of Chiropractic Examiners or before the Office of Administrative Hearings. It does not apply to conferences or other informal investigations or proceedings.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the date, time, and place of the hearing. It shall also state the issues or charges involved in the proceeding, provided, however, that if by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issues is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> <paragraph num="B."> <text>Service upon a party shall be by delivery of the charging document and a copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>Every party appearing at formal hearings has the right to appear in proper person, or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Pre-hearing Procedures."> <paragraph num="A."> <text>Pre-hearing Conferences. The Board may set a pre-hearing conference as it deems appropriate.</text> </paragraph> <paragraph num="B."> <text>Oaths and Subpoenas. The Board may administer oaths and compel the attendance of witnesses and the production of physical evidence before it from witnesses upon whom process is served anywhere within the State as in civil cases in the circuit court of the county or of Baltimore City, by subpoena issued over the signature of the President or Secretary and the seal of the Board. Upon a request by a party and statement under oath that the testimony or evidence is necessary to their defense, the Board shall issue a subpoena on their behalf.</text> </paragraph> <paragraph num="C."> <text>All motions filed by a party with the Board or the Office of Administrative Hearings, as appropriate, shall be accompanied by a memorandum of points and authorities and shall be filed at least 15 days before the hearing. A copy shall be served on the opposing party. Any response shall be filed with the Board or the Office of Administrative Hearings, as appropriate, at least 7 days before the hearing and a copy shall be served on the opposing party.</text> </paragraph> <paragraph num="D."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §A(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report.</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Parties are not entitled to discovery of items other than as listed in §§D and E of this regulation.</text> </paragraph> <paragraph num="G."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="H."> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="J."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The Board shall conduct hearings before a quorum of the Board.</text> </paragraph> <paragraph num="(2)"> <text>For purposes of a hearing under this chapter, four Board members present and entitled to vote shall constitute a quorum.</text> </paragraph> <paragraph num="(3)"> <text>Board action shall be by majority vote of all the members then serving.</text> </paragraph> <paragraph num="(4)"> <text>The President, or the President's designee, shall be the presiding officer, and shall have complete charge of the hearing, permit the examination of witnesses, admit evidence, rule on the admissibility of evidence, and adjourn or recess the hearing from time to time.</text> </paragraph> <paragraph num="(5)"> <text>The presiding officer may set reasonable time limits in arguments and presentation of evidence.</text> </paragraph> <paragraph num="(6)"> <text>The presiding officer shall be responsible for decorum in hearings and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board, and, upon such a request, this counsel has all the rights with regard to the:</text> <paragraph num="(a)"> <text>Submission of evidence, examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(b)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(c)"> <text>Filing of objections, exceptions, and motions as counsel for any party.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Order of Procedure. The State shall present its case first. Then the respondent shall present his case. After this the State may present rebuttal.</text> </paragraph> <paragraph num="D."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Every party has the right on every genuine issue to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine every witness called by the agency, or other party;</text> </paragraph> <paragraph num="(c)"> <text>Submit rebuttal evidence, present summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>File objections, exceptions, and motions, except that when a party is represented by counsel, all the submissions of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by this counsel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer, or the presiding officer's designee, may examine:</text> <paragraph num="(a)"> <text>A witness called by a party; and</text> </paragraph> <paragraph num="(b)"> <text>An individual in attendance at the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A member of the Board may examine a witness called by a party.</text> </paragraph> <paragraph num="(5)"> <text>The Board may submit evidence from an investigative file to other administrative and criminal investigative offices to assist in the investigation and prosecution of a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcripts."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceeding, or part of it, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <paragraph num="A."> <text>Every decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law.</text> </paragraph> <paragraph num="B."> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or attorney of record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>Any party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on him of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it shall stay the enforcement of the order, or excuse the person affected by it for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal."> <text>Any person whose license has been revoked or suspended by the Board, or any person placed on probation or reprimand under the regulations in this chapter, may appeal the Board's decision as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §3-205(a)(1); State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 7, 1983 (10:22 Md. R. 1966)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 29, 2000 (27:10 Md. R. 966)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 29, 2000 (27:10 Md. R. 966); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Subtitle amended to be, Board of Chiropractic Examiners, Rules of Procedure for Board Hearings, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="03" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>A chiropractor may advertise chiropractic services subject to the provisions of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifications."> <paragraph num="A."> <text>In an advertisement, a chiropractor shall include at least the chiropractor's:</text> <paragraph num="(1)"> <text>Name;</text> </paragraph> <paragraph num="(2)"> <text>Office address;</text> </paragraph> <paragraph num="(3)"> <text>Telephone number; and</text> </paragraph> <paragraph num="(4)"> <text>Educational degree.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In an advertisement, a chiropractor may state the name of the chiropractor's specialty only if that specialty is approved by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibitions."> <text>An advertisement may not contain statements that:</text> <paragraph num="A."> <text>Contain a misrepresentation of facts or do not reasonably identify the practice as chiropractic;</text> </paragraph> <paragraph num="B."> <text>Are likely to mislead or deceive because in context the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="C."> <text>Intend to, or are likely to, create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="D."> <text>Relate to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully disclosing all variables and other relevant factors;</text> </paragraph> <paragraph num="E."> <text>Convey the impression that the chiropractor could influence improperly any public body, official, corporation, or any person on behalf of a patient;</text> </paragraph> <paragraph num="F."> <text>Contain representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or to be deceived;</text> </paragraph> <paragraph num="G."> <text>Contain representations that the chiropractor is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States;</text> </paragraph> <paragraph num="H."> <text>Contain representations regarding the use of any equipment, treatment, or procedure not within the accepted, prudent practice of chiropractic; or</text> </paragraph> <paragraph num="I."> <text>Promise payment, compensation, prizes, or remuneration of any intrinsic value.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <paragraph num="A."> <text>A chiropractor may not engage in solicitation, including but not limited to, in-person, telephone, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Amounts to fraud, undue influence, intimidation, or overreaching;</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A chiropractor shall also be accountable under this regulation if the chiropractor uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §3-401, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 24, 1983 (10:21 Md. R. 1902)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Subtitle and Chapter name amended to be, Board of Chiropractic Examiners, Advertising, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C repealed effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J repealed effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="04" heading="Licensure by Credentials for Chiropractors"> <regulation prefix="Regulation" num=".01" heading="Preface and Scope."> <paragraph num="A."> <text>Preface. The Board of Chiropractic Examiners has established guidelines for licensure by credentials. This method of licensure is a special privilege granted by present statute, and is secured for those candidates who possess the necessary credentials required to practice chiropractic in the State. The requirements for licensure are stringent in order to insure the public is adequately protected and that licensure may be granted only to those who qualify by virtue of clinical competency and professional expertise.</text> </paragraph> <paragraph num="B."> <text>Scope. This chapter applies to all chiropractors seeking licensure by credentials in Maryland. Since licensure by credentials is a privilege, the Board reserves the right to accept or deny this method of licensure based on Regulation .02 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility."> <paragraph num="A."> <text>A chiropractor is eligible for licensure by credentials if the applicant has graduated and received the degree Doctor of Chiropractic (D.C.) from a chiropractic college accredited by the Council on Chiropractic Education (C.C.E.) or its successor.</text> </paragraph> <paragraph num="B."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Be of good moral character and have submitted to the Board three letters of recommendation, one of which shall be sent by the state licensing board in which the applicant is currently licensed;</text> </paragraph> <paragraph num="(2)"> <text>Meet all the qualifications set forth in the Health Occupations Article, §3-302, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Be currently licensed in another state by virtue of passing an examination that is similar to the examination for which the applicant is seeking licensure by credentials;</text> </paragraph> <paragraph num="(4)"> <text>Have been in active clinical practice in the state for which the applicant was licensed by examination for the 5 years preceding application or has had full-time faculty status at a chiropractic college accredited by the Council on Chiropractic Education or its successor for at least 5 years before application; and</text> </paragraph> <paragraph num="(5)"> <text>Take and pass the Maryland jurisprudence and the National Board of Chiropractic Examiners (NBCE) Special Purposes Examination for Chiropractic (SPEC) examinations with minimum scores of 75 percent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A SPEC exam is not required for an applicant who has passed parts I through IV of the NBCE Examination with a minimum score of 75 percent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Procedures."> <paragraph num="A."> <text>An applicant shall submit the necessary information as set forth in the Health Occupations Article, §3-303, Annotated Code Maryland.</text> </paragraph> <paragraph num="B."> <text>The Board may investigate the applicant to insure compliance with all provisions of this chapter.</text> </paragraph> <paragraph num="C."> <text>An applicant shall submit to the Board satisfactory evidence of having completed a State and national criminal history records check in accordance with Health Occupations Article, §3–302.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Board may not issue a license or registration if the criminal history records information required under §C of this regulation has not been received.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements of Licensure."> <text>At the Board's discretion, an applicant shall appear before the Board and demonstrate clinical competency in a manner and time to be determined by the Board.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Fees."> <paragraph num="A."> <text>The fee for licensure by credentials shall be the same as that for licensure by examination.</text> </paragraph> <paragraph num="B."> <text>Additional fees may be assessed by the Board for investigatory purposes.</text> </paragraph> <paragraph num="C."> <text>The application fee is non-refundable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-302.1 and 3-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 17, 1984 (11:25 Md. R. 2134)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 6, 2001 (28:15 Md. R. 1398); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, D adopted effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Subtitle name amended to be, Board of Chiropractic Examiners, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="05" heading="Chiropractic Externship Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations apply to all:</text> <paragraph num="A."> <text>Chiropractic externs, chiropractic extern applicants, and licensed chiropractors who are extension faculty members of a chiropractic college accredited by the Council on Chiropractic Education or its successor; and</text> </paragraph> <paragraph num="B."> <text>Licensed chiropractors approved by the Board to provide an externship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited Board-approved educational institution” means a chiropractic school, college, or university accredited by the Council on Chiropractic Education or its successor.</text> </paragraph> <paragraph num="(2)"> <text>“Approved program” means a program that has been approved by the Board and the Council on Chiropractic Education or its successor.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Maryland Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(4)"> <text>“Chiropractic extern program” means:</text> <paragraph num="(a)"> <text>A 2-semester clinical program:</text> <paragraph num="(i)"> <text>In which a chiropractic student, that has completed all requirements to graduate, participates under the direct supervision of a licensed chiropractor who has been approved by the Board to serve as a preceptor; and</text> </paragraph> <paragraph num="(ii)"> <text>That operates in a facility where chiropractic services have been approved by the Board; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A 6-month clinical program in which an individual has:</text> <paragraph num="(i)"> <text>Begun the process of applying for licensure, but has not met certain requirements set forth under COMAR 10.43.04;</text> </paragraph> <paragraph num="(ii)"> <text>Graduated from an accredited Board-approved educational institution;</text> </paragraph> <paragraph num="(iii)"> <text>Taken and passed the examination of the National Board of Chiropractic Examiners (NBCE);</text> </paragraph> <paragraph num="(iv)"> <text>Been approved for an extern license by the Board; and</text> </paragraph> <paragraph num="(v)"> <text>Agreed to practice under the direct supervision of a preceptor who is a Board-approved licensed chiropractor while the extern license is in effect.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means a licensed chiropractor:</text> <paragraph num="(a)"> <text>Remains on the premises at all times;</text> </paragraph> <paragraph num="(b)"> <text>Directly supervises and continuously monitors the extern’s performance within the practice; and</text> </paragraph> <paragraph num="(c)"> <text>Is immediately available to offer assistance.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Extern” means:</text> <paragraph num="(a)"> <text>An individual who has:</text> <paragraph num="(i)"> <text>Enrolled in an accredited Board-approved educational institution and has completed all requirements for the Doctor of Chiropractic program except for the final clinical phase of the program; or</text> </paragraph> <paragraph num="(ii)"> <text>Graduated from an accredited Board-approved educational institution and is in the process of applying to the Board for a license to practice chiropractic, but has yet to meet certain requirements set forth under COMAR 10.43.04 to qualify for a license; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A chiropractor licensed in another state who is in the process of applying to the Board for a license to practice chiropractic, but has yet to meet certain requirements set forth under COMAR 10.43.04 to qualify for a license.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Extern applicant” means an individual who applies to the Board to be approved for the chiropractic externship program.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed chiropractor” means a chiropractor who is licensed by the Board to practice chiropractic or to practice chiropractic with the right to practice physical therapy, and whose license is in good standing.</text> </paragraph> <paragraph num="(9)"> <text>“Preceptor or extension faculty member” means a licensed chiropractor actively practicing in the State in good standing who has been appointed to the extension faculty of an accredited Board-approved educational institution.</text> </paragraph> <paragraph num="(10)"> <text>“Preceptor sponsor” means a licensed chiropractor approved by the Board to supervise the following who are in the process of applying for licensure:</text> <paragraph num="(a)"> <text>A recent graduate that has completed a preceptorship program; or</text> </paragraph> <paragraph num="(b)"> <text>A chiropractor licensed in another state, whose license is in good standing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Eligibility."> <paragraph num="A."> <text>An extern applicant is eligible for approval in the chiropractic extern program if the applicant is:</text> <paragraph num="(1)"> <text>Currently enrolled in an approved program that is recognized by the Board as:</text> <paragraph num="(a)"> <text>Requiring adequate clinical training; and</text> </paragraph> <paragraph num="(b)"> <text>Maintaining an acceptable course of chiropractic instruction;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A recent graduate that has completed a preceptorship program; or</text> </paragraph> <paragraph num="(3)"> <text>A chiropractor licensed in another state, whose license is in good standing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An extern applicant shall:</text> <paragraph num="(1)"> <text>Meet all the qualifications as set forth in Health Occupations Article, §§3-302 and 3-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be in good standing:</text> <paragraph num="(a)"> <text>At the accredited Board-approved educational institution; or</text> </paragraph> <paragraph num="(b)"> <text>In the state currently licensed;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit the completed application forms as required by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Pay the application fee as set forth in COMAR 10.43.06;</text> </paragraph> <paragraph num="(5)"> <text>Submit to a criminal background check;</text> </paragraph> <paragraph num="(6)"> <text>Have three letters of recommendation sent directly to the Board:</text> <paragraph num="(a)"> <text>From clinical science professors at the extern’s accredited Board-approved educational institution attesting to the applicant’s good moral character and clinical abilities; or</text> </paragraph> <paragraph num="(b)"> <text>Two of which shall be from chiropractors attesting to the applicant’s good moral character and one letter from the licensing board of the state in which the applicant is currently licensed attesting that the license is in good standing; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Be withdrawn from the program if the applicant has not obtained a license to practice chiropractic within 6 months from the date the externship is approved.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Permitted Delegation."> <paragraph num="A."> <text>A preceptor who is a Board-approved licensed chiropractor or an extension faculty member may delegate duties within the scope of one’s license, which constitute the practice of chiropractic, to an extern in accordance with COMAR 10.43.</text> </paragraph> <paragraph num="B."> <text>A preceptor may permit an extern to perform chiropractic duties as part of a clinical program, subject to the following conditions:</text> <paragraph num="(1)"> <text>The preceptor shall maintain direct supervision of the extern;</text> </paragraph> <paragraph num="(2)"> <text>The clinical training program shall be governed by a written agreement between the extern’s accredited Board-approved educational institution and the preceptor that:</text> <paragraph num="(a)"> <text>Has been approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Describes the specific program;</text> </paragraph> <paragraph num="(c)"> <text>Enumerates the functions the extern may perform; and</text> </paragraph> <paragraph num="(d)"> <text>Indicates the legal responsibilities assumed by the extern’s accredited Board-approved educational institution;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The accredited Board-approved educational institution shall submit to the Board the names of those doctors selected as extension faculty members. The Board shall notify the educational institution of those approved for the program;</text> </paragraph> <paragraph num="(4)"> <text>A licensed chiropractor may not supervise more than one extern during the same period;</text> </paragraph> <paragraph num="(5)"> <text>A licensed chiropractor may delegate or permit only duties and functions which are established as part of the clinical training program;</text> </paragraph> <paragraph num="(6)"> <text>The extern may not supervise chiropractic assistants or trainees; and</text> </paragraph> <paragraph num="(7)"> <text>An extern applicant that is a licensed chiropractor in another state shall have a preceptor sponsor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A preceptor may permit a licensed extern to perform chiropractic duties as part of the chiropractic practice providing the preceptor:</text> <paragraph num="(1)"> <text>Maintains direct supervision of the extern; and</text> </paragraph> <paragraph num="(2)"> <text>Ensures the compliance of the extern to the conditions set forth under Regulation .03B(7) of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A preceptor with a license to practice chiropractic with physical therapy privileges may supervise an applicant applying for a license to practice chiropractic:</text> <paragraph num="(1)"> <text>With physical therapy privileges; and</text> </paragraph> <paragraph num="(2)"> <text>Without physical therapy privileges.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A preceptor with a license to practice chiropractic without physical therapy privileges may only supervise an extern applying for a license to practice chiropractic without physical therapy privileges.</text> </paragraph> <paragraph num="F."> <text>Malpractice insurance in an amount defined by the Council on Chiropractic Education shall be obtained:</text> <paragraph num="(1)"> <text>Before the clinical program begins, by the extern’s:</text> <paragraph num="(a)"> <text>Accredited Board-approved educational institution; and</text> </paragraph> <paragraph num="(b)"> <text>Extension faculty member participating in the clinical program; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>By the preceptor sponsor of an extern applicant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A licensed chiropractor seeking preceptor status shall:</text> <paragraph num="(1)"> <text>Submit a completed written application to the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the fee as set forth in COMAR 10.43.06;</text> </paragraph> <paragraph num="(3)"> <text>Provide written evidence of malpractice insurance as requested by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Agree to an administrative inspection of the chiropractic office spaces, equipment, and records as directed by the Board.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-205 and 3-301, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 17, 1985 (12:12 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 6, 2001 (28:15 Md. R. 1398); October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective October 22, 2007 (34:21 Md. R. 1915); June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Subtitle name amended to be, Board of Chiropractic Examiners, Chiropractic Externship Program, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 2, 2017 (43:26 Md. R. 1446); May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="06" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs those who are licensed and registered or who are applying for licensure or registration by the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees for Chiropractic Licensure and Registration."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Application fee . . . $200;</text> </paragraph> <paragraph num="B."> <text>Examination fee . . . $300;</text> </paragraph> <paragraph num="C."> <text>Licensure fee . . . $200;</text> </paragraph> <paragraph num="D."> <text>Reexamination fee . . . $400;</text> </paragraph> <paragraph num="E."> <text>Renewal fee to be paid on or before August 31 of the renewal year . . . $700;</text> </paragraph> <paragraph num="F."> <text>Late renewal fee to be paid, in addition to the renewal fee, for renewal submitted within 30 days after August 31 . . . $500;</text> </paragraph> <paragraph num="G."> <text>Reinstatement fee, in addition to the renewal fee and late fee in §§E and F of this regulation, for each renewal period that the license was expired after September 30 . . . $300;</text> </paragraph> <paragraph num="H."> <text>Duplicate license fee . . . $50;</text> </paragraph> <paragraph num="I."> <text>Duplicate license ordered at renewal . . . $25;</text> </paragraph> <paragraph num="J."> <text>Inactive status fee . . . $350;</text> </paragraph> <paragraph num="K."> <text>Reactivation fee charged to move licensure status from inactive to active status . . . $200;</text> </paragraph> <paragraph num="L."> <text>Preceptorship application fee . . . $300;</text> </paragraph> <paragraph num="M."> <text>Extern application fee . . . $50;</text> </paragraph> <paragraph num="N."> <text>Licensure by credentials application . . . $750;</text> </paragraph> <paragraph num="O."> <text>Penalty for returned checks . . . $50;</text> </paragraph> <paragraph num="P."> <text>Verification of licensure . . . $35;</text> </paragraph> <paragraph num="Q."> <text>Chiropractic assistant examination fee . . . $300;</text> </paragraph> <paragraph num="R."> <text>Chiropractic assistant renewal fee . . . $250;</text> </paragraph> <paragraph num="S."> <text>Penalty for failure to maintain correct address with the Board . . . $200;</text> </paragraph> <paragraph num="T."> <text>Late renewal fee for chiropractic assistants . . . $200;</text> </paragraph> <paragraph num="U."> <text>Supervising chiropractor application fee . . . $300;</text> </paragraph> <paragraph num="V."> <text>Continuing Education Course processing review fee per submission . . . $25;</text> </paragraph> <paragraph num="W."> <text>Mailing labels or roster . . . $200;</text> </paragraph> <paragraph num="X."> <text>Chiropractic assistant registration fee . . . $100;</text> </paragraph> <paragraph num="Y."> <text>Paper copy of laws and regulations . . . $25.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Refunds."> <paragraph num="A."> <text>Fees are nonrefundable with the exception of the examination fee.</text> </paragraph> <paragraph num="B."> <text>The examination fee may be refunded at the discretion of the Board if the applicant's written request is received by registered mail at least 14 days before the examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Assessment for Health Care Professionals."> <text>The applicant shall pay at the time of license renewal a fee for health care professionals, assessed by the Maryland Health Care Commission (MHCC), as specified in COMAR 10.25.02.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-205 and 3-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 30, 1992 (19:6 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective June 23, 1993 (20:14 Md. R. 1166); emergency status expired December 31, 1993</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 14, 1994 (21:3 Md. R. 194)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective August 23, 1999 (26:20 Md. R. 1543); revised permanently effective December 13, 1999 (26:25 Md. R. 1899)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective August 6, 2008 (35:18 Md. R. 1599); amended permanently effective October 6, 2008 (35:20 Md. R. 1776)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02N, V amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02P—S adopted effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02T adopted effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective August 6, 2008 (35:18 Md. R. 1599); amended permanently effective October 6, 2008 (35:20 Md. R. 1776)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended and .03N adopted effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Subtitle and Chapter name amended to be, Board of Chiropractic Examiners, Fees, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="07" heading="Chiropractic Assistants"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Chiropractic assistant” means an individual who is registered by the Board to perform the duties authorized under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Chiropractic assistant program” means a structured 1-year program of clinical chiropractic training under a Board-licensed supervising chiropractor in order to qualify and apply for a registration as a Maryland chiropractic assistant.</text> </paragraph> <paragraph num="(4)"> <text>“Chiropractic assistant trainee” means a person who is:</text> <paragraph num="(a)"> <text>Undergoing training to become a chiropractic assistant; or</text> </paragraph> <paragraph num="(b)"> <text>Applying to the Board for registration as a chiropractic assistant.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means supervision provided by a supervising chiropractor who is personally present and immediately available in the area where the procedures are performed to give aid, direction, and instruction when certain procedures or activities are performed by a chiropractic assistant or a chiropractic assistant trainee.</text> </paragraph> <paragraph num="(6)"> <text>“Established patient” means an individual who has received professional services from a practicing supervising chiropractor who belongs to the same group practice in the past 3 years.</text> </paragraph> <paragraph num="(7)"> <text>“Inactive status” means the period of time that a registration is on hold.</text> </paragraph> <paragraph num="(8)"> <text>“Indirect supervision” means supervision by a supervising chiropractor that is provided by a phone call or text to give aid, direction, and instructions when certain activities, as set forth under Regulation .10 of this chapter, are performed by a chiropractic assistant.</text> </paragraph> <paragraph num="(9)"> <text>“Practice day” means the hours of physical practice with a patient, excluding the office’s designated lunch or exclusive administrative time.</text> </paragraph> <paragraph num="(10)"> <text>“Supervising chiropractor” means a chiropractor licensed by the Board in chiropractic with the right to practice physical therapy as set forth in Health Occupations Article, §3-301(c), Annotated Code of Maryland, and approved as a supervising chiropractor by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Chiropractic Applicant or Assistant Qualifications and Training."> <paragraph num="A."> <text>At the time of application on the Request to Employ form for training, an applicant shall:</text> <paragraph num="(1)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Be a U.S. Citizen or hold federal documentation authorizing employment;</text> </paragraph> <paragraph num="(4)"> <text>Be proficient in the English language sufficiently to allow for clear interaction with patients;</text> </paragraph> <paragraph num="(5)"> <text>Be enrolled in a Board-approved Cardiopulmonary Resuscitation (CPR) class within 4 months of the commencement of the chiropractic assistant training or be currently CPR certified;</text> </paragraph> <paragraph num="(6)"> <text>Be a graduate of a high school or hold a GED; and</text> </paragraph> <paragraph num="(7)"> <text>Have any foreign transcripts professionally interpreted and certified</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who otherwise qualifies for being employed within the 1-year chiropractic assistant training program shall:</text> <paragraph num="(1)"> <text>Complete the profile portion of the application;</text> </paragraph> <paragraph num="(2)"> <text>Provide the supervising chiropractor with:</text> <paragraph num="(a)"> <text>The requested documentation;</text> </paragraph> <paragraph num="(b)"> <text>A diploma or transcripts;</text> </paragraph> <paragraph num="(c)"> <text>A valid State picture identification; and</text> </paragraph> <paragraph num="(d)"> <text>An authorization to work in the U.S. for the application documentation, if applicable; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit satisfactory evidence of having completed a State and national criminal history records check in accordance with Health Occupations Article, §3-302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The supervising chiropractor shall complete and submit to the Board a legible application and documentation proving that the applicant meets the qualifications listed in §A of this regulation.</text> </paragraph> <paragraph num="D."> <text>An applicant may not commence work or training until the supervising chiropractor receives an authorization letter from the Board.</text> </paragraph> <paragraph num="E."> <text>Within 120 days of the date of hire, the applicant shall:</text> <paragraph num="(1)"> <text>Satisfactorily complete the required CPR class;</text> </paragraph> <paragraph num="(2)"> <text>Enroll in a Board-approved chiropractic assistant 103-hour course of instruction; and</text> </paragraph> <paragraph num="(3)"> <text>Submit proof of completion of both requirements in a timely manner on the form provided by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Within 1 calendar year of the date of hire, the applicant shall satisfactorily complete:</text> <paragraph num="(1)"> <text>A minimum of 520 in-service training hours, of which:</text> <paragraph num="(a)"> <text>The initial 20 hours shall consist of observation procedures as listed in Regulation .09 of this chapter and performed by the supervising chiropractor or registered chiropractic assistant; and</text> </paragraph> <paragraph num="(b)"> <text>The remaining 500 hours shall consist of direct supervision by a supervising chiropractor in the treatment area; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A 103 hour course of instruction from a Board-approved provider with a minimum of:</text> <paragraph num="(a)"> <text>24 hours in anatomy and terminology;</text> </paragraph> <paragraph num="(b)"> <text>3 hours in jurisprudence and risk management; and</text> </paragraph> <paragraph num="(c)"> <text>76 hours in physical therapy modalities and indications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>No waivers, extensions, or exceptions shall be granted except by majority vote of the Board .</text> </paragraph> <paragraph num="H."> <text>Failure to meet the requirements of §§E and F of this regulation shall result in immediate suspension from the applicant training program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Chiropractic Assistant Examinations and Registration."> <paragraph num="A."> <text>A chiropractic assistant trainee who otherwise qualifies for registration is entitled to be examined as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>The chiropractic assistant trainee shall pass a Board proficiency and jurisprudence examination.</text> </paragraph> <paragraph num="C."> <text>The chiropractic assistant trainee shall:</text> <paragraph num="(1)"> <text>Pay to the Board as set forth in COMAR 10.43.06:</text> <paragraph num="(a)"> <text>A nonrefundable application fee; and</text> </paragraph> <paragraph num="(b)"> <text>An examination fee; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Submit all fees, transcripts, and application documentation postmarked no later than 30 days before the examination date.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Give examinations to chiropractic assistant trainees at least twice a year, at the times and places that the Board determines;</text> </paragraph> <paragraph num="(2)"> <text>Notify each qualified chiropractic assistant trainee of the time and place of examinations; and</text> </paragraph> <paragraph num="(3)"> <text>Determine the subject scope, form, and passing score for examination.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reexaminations.</text> <paragraph num="(1)"> <text>If the chiropractic assistant trainee fails the examination twice, the chiropractic assistant trainee may retake the examination only if the chiropractic assistant trainee:</text> <paragraph num="(a)"> <text>Pays the reexamination fee; and</text> </paragraph> <paragraph num="(b)"> <text>Completes additional minimum 10 hour refresher classroom training courses as approved by the Board in areas of deficiency.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A chiropractic assistant trainee who fails the examination twice may not perform in-service training duties in direct patient care or treatment under Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A chiropractic assistant shall notify the Board of any change in the name or electronic or physical address of the chiropractic assistant, in writing, within 60 days after the change occurs.</text> </paragraph> <paragraph num="G."> <text>A chiropractic assistant shall display the registration and any current renewal registration conspicuously in the space where the registration holder is engaged in practice, including in any temporary space, or in any exhibit location.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Achieving Supervising Chiropractor Status."> <paragraph num="A."> <text>Only a supervising chiropractor may work with or train a chiropractic assistant or applicant.</text> </paragraph> <paragraph num="B."> <text>Only an active, licensed chiropractor who holds physical therapy privileges and has no outstanding disciplinary orders may qualify for supervising chiropractor status.</text> </paragraph> <paragraph num="C."> <text>An applicant for supervising chiropractor status shall:</text> <paragraph num="(1)"> <text>Submit to the Board the required application and fee;</text> </paragraph> <paragraph num="(2)"> <text>Successfully pass the Board supervising chiropractor examination and interview; and</text> </paragraph> <paragraph num="(3)"> <text>Satisfactorily follow Board regulations and statutes.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may deny, suspend, or revoke supervising chiropractor status for violation of the Board’s statutes and regulations by the supervising chiropractor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of the Supervising Chiropractor."> <text>The supervising chiropractor shall:</text> <paragraph num="A."> <text>Submit:</text> <paragraph num="(1)"> <text>The required Board Request to Employ form before undertaking any hands on training or coursework with any chiropractic assistant applicant; and</text> </paragraph> <paragraph num="(2)"> <text>All other Board-required reports and forms in a timely manner as determined by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notify the Board and course instructor or instructors of any change in status of any chiropractic applicant or assistant within 10 days of the change, including:</text> <paragraph num="(1)"> <text>Reasons for the change in status;</text> </paragraph> <paragraph num="(2)"> <text>Training received by the applicant or assistant;</text> </paragraph> <paragraph num="(3)"> <text>Hours completed by the applicant or assistant; and</text> </paragraph> <paragraph num="(4)"> <text>The applicant's or assistant's forwarding address;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Maintain accurate, legible, and comprehensive records of all clinical training provided to the chiropractic applicant or assistant, including, but not limited to:</text> <paragraph num="(1)"> <text>Dates and times and duration of training as described in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Modalities;</text> </paragraph> <paragraph num="(3)"> <text>Equipment used; and</text> </paragraph> <paragraph num="(4)"> <text>Any other information as directed by the Board;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Follow indirect supervision procedures set forth under Regulation .10 of this chapter;</text> </paragraph> <paragraph num="E."> <text>Immediately produce the records described in §C of this regulation and Regulation .10D(1) of this chapter upon request or audit by the Board;</text> </paragraph> <paragraph num="F."> <text>Promptly:</text> <paragraph num="(1)"> <text>Report a chiropractic applicant or assistant not making satisfactory training progress; and</text> </paragraph> <paragraph num="(2)"> <text>Report before the Board as directed regarding the details of the training program issue;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Maintain competency in knowledge of applicable laws and regulations and successfully complete any jurisprudence requirements that may be directed by the Board;</text> </paragraph> <paragraph num="H."> <text>Ensure that all patient records accurately and legibly reflect the extent and degree of the involvement or assistance of the chiropractic applicant or assistant;</text> </paragraph> <paragraph num="I."> <text>Submit the in-service training hours and verification of chiropractic applicant or assistant competency on a form provided by the Board within 30 days of completion of training or transfer of the chiropractic applicant or assistant to another supervising chiropractor;</text> </paragraph> <paragraph num="J."> <text>Be fully responsible for the safe and competent performance of the chiropractic applicant or assistant at all times; and</text> </paragraph> <paragraph num="K."> <text>Provide direct supervision to not more than five chiropractic assistants or applicants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Supervising Chiropractor Prohibited Acts."> <paragraph num="A."> <text>The supervising chiropractor may not:</text> <paragraph num="(1)"> <text>Delegate responsibilities in any manner to anyone not holding supervising chiropractor status;</text> </paragraph> <paragraph num="(2)"> <text>Leave the treatment area:</text> <paragraph num="(a)"> <text>When treating a patient;</text> </paragraph> <paragraph num="(b)"> <text>When a chiropractic applicant is treating a patient; or</text> </paragraph> <paragraph num="(c)"> <text>During a chiropractic applicant’s 20-hour observation period;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Permit a chiropractic applicant to treat a patient without the presence of the supervising chiropractor in the treatment area; or</text> </paragraph> <paragraph num="(4)"> <text>Be unavailable by phone call or text when a chiropractic assistant is treating an established patient with an established treatment program as set forth under Regulation .10B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The license of a licensee who violates this regulation shall be subject to the penalties set forth in COMAR 10.43.10.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Activities That May Be Performed by Chiropractic Applicants and Assistants Without Direct Supervision."> <text>A chiropractic applicant or assistant may perform the following activities without the direct supervision of a supervising chiropractor:</text> <paragraph num="A."> <text>Taking the height, the weight, and vital signs of a patient and recording them in the patient record;</text> </paragraph> <paragraph num="B."> <text>Assisting in the dressing, undressing, and draping of a patient;</text> </paragraph> <paragraph num="C."> <text>Removing and applying assistive and supportive devices;</text> </paragraph> <paragraph num="D."> <text>Observing treatments and modalities as authorized by the supervising chiropractor;</text> </paragraph> <paragraph num="E."> <text>Providing preprinted non-patient specific health and chiropractic concepts and information that has been approved and reviewed by the supervising chiropractor; and</text> </paragraph> <paragraph num="F."> <text>Taking patient histories.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Activities That May Be Performed by Chiropractic Assistants or Chiropractic Assistant Trainees Under Direct Supervision of a Supervising Chiropractor."> <text>A chiropractic assistant or a chiropractic assistant trainee may perform the following activities under the direct supervision of a supervising chiropractor who is in the treatment area:</text> <paragraph num="A."> <text>Functional activities of daily living and hygiene;</text> </paragraph> <paragraph num="B."> <text>Gait practice and ambulation;</text> </paragraph> <paragraph num="C."> <text>Demonstration, administration, and observation of therapeutic exercises as prescribed by a supervising chiropractor;</text> </paragraph> <paragraph num="D."> <text>Assist in moving a patient within the treatment area;</text> </paragraph> <paragraph num="E."> <text>Contrast baths;</text> </paragraph> <paragraph num="F."> <text>Hot and cold packs;</text> </paragraph> <paragraph num="G."> <text>Hubbard tank;</text> </paragraph> <paragraph num="H."> <text>Infrared, ultraviolet irradiation, non-laser light therapy, and non-ablative therapeutic laser;</text> </paragraph> <paragraph num="I."> <text>Muscle stimulation;</text> </paragraph> <paragraph num="J."> <text>Electrotherapy;</text> </paragraph> <paragraph num="K."> <text>Paraffin baths;</text> </paragraph> <paragraph num="L."> <text>Traction therapy;</text> </paragraph> <paragraph num="M."> <text>Ultrasound;</text> </paragraph> <paragraph num="N."> <text>Whirlpool;</text> </paragraph> <paragraph num="O."> <text>Diathermy;</text> </paragraph> <paragraph num="P."> <text>Therapeutic massage, if licensed under Health Occupations Article, Title 6, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="Q."> <text>Mechanical or computerized examination procedures for the sole purpose of collecting data subject to the following conditions:</text> <paragraph num="(1)"> <text>All data will later be used and interpreted by the chiropractor to form a diagnosis and treatment plan; and</text> </paragraph> <paragraph num="(2)"> <text>No test may be performed that requires diagnosis or interpretation as part of the data collecting or testing procedure.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Chiropractic Applicant or Assistant Prohibited Acts."> <text>A chiropractic applicant or assistant may not engage in any of the following activities:</text> <paragraph num="A."> <text>Communicate an evaluation or diagnosis to a patient;</text> </paragraph> <paragraph num="B."> <text>Perform an act requiring the professional skill or judgment of a licensed chiropractor;</text> </paragraph> <paragraph num="C."> <text>Perform orthopedic or neurological tests;</text> </paragraph> <paragraph num="D."> <text>Engage in dietary or nutritional advice or counseling; or</text> </paragraph> <paragraph num="E."> <text>Other acts not within the chiropractic applicant or assistant's specified scope.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Activities That May Be Performed by Chiropractic Assistants Under Indirect Supervision of a Supervising Chiropractor."> <paragraph num="A."> <text>Indirect supervision may only be provided by a supervising chiropractor to a chiropractic assistant who is treating an established patient.</text> </paragraph> <paragraph num="B."> <text>A chiropractic assistant may perform the following activities under the indirect supervision of a supervising chiropractor to an established patient with an established treatment program for not more than 10 percent of the treatment time in a given 30 days, without exceeding 3 consecutive days in a given week:</text> <paragraph num="(1)"> <text>Functional activities of daily living and hygiene;</text> </paragraph> <paragraph num="(2)"> <text>Gait practice, ambulation, administration, and observation of therapeutic exercises as prescribed by a supervising chiropractor;</text> </paragraph> <paragraph num="(3)"> <text>Assist in moving a patient within the treatment area;</text> </paragraph> <paragraph num="(4)"> <text>Contrast baths;</text> </paragraph> <paragraph num="(5)"> <text>Hot and cold packs;</text> </paragraph> <paragraph num="(6)"> <text>Hubbard tank;</text> </paragraph> <paragraph num="(7)"> <text>Infrared, ultraviolet irradiation, nonlaser light therapy, and nonablative therapeutic laser;</text> </paragraph> <paragraph num="(8)"> <text>Muscle stimulation;</text> </paragraph> <paragraph num="(9)"> <text>Electrotherapy;</text> </paragraph> <paragraph num="(10)"> <text>Paraffin baths;</text> </paragraph> <paragraph num="(11)"> <text>Traction therapy;</text> </paragraph> <paragraph num="(12)"> <text>Ultrasound;</text> </paragraph> <paragraph num="(13)"> <text>Whirlpool;</text> </paragraph> <paragraph num="(14)"> <text>Diathermy;</text> </paragraph> <paragraph num="(15)"> <text>Therapeutic massage, if licensed under Health Occupations Article, Title 6, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(16)"> <text>Mechanical or computerized examination procedures for the sole purpose of collecting data subject to the following conditions:</text> <paragraph num="(a)"> <text>All data will later be used and interpreted by the chiropractor to form a diagnosis and treatment plan; and</text> </paragraph> <paragraph num="(b)"> <text>No test may be performed that requires diagnosis or interpretation as part of the data collecting or testing procedure.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A chiropractic assistant who participates in indirect supervision shall be:</text> <paragraph num="(1)"> <text>In good standing with the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Trained and proficient in the office’s indirect supervision protocol, which includes:</text> <paragraph num="(a)"> <text>Informed consent to the patient; and</text> </paragraph> <paragraph num="(b)"> <text>Immediate access to the supervising chiropractor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The supervising chiropractor shall:</text> <paragraph num="(1)"> <text>Prior to the implementation of indirect supervision, establish and make readily available an:</text> <paragraph num="(a)"> <text>Emergency procedures protocol; and</text> </paragraph> <paragraph num="(b)"> <text>Indirect supervision protocol;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain a log of indirect supervision treatment, which includes:</text> <paragraph num="(a)"> <text>Patient’s name or identification information; and</text> </paragraph> <paragraph num="(b)"> <text>Treatment:</text> <paragraph num="(i)"> <text>Date;</text> </paragraph> <paragraph num="(ii)"> <text>Time initiated;</text> </paragraph> <paragraph num="(iii)"> <text>Duration; and</text> </paragraph> <paragraph num="(iv)"> <text>Procedure or activity provided; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Review or update, or both, indirect supervision orders every 30 days.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An indirect supervision protocol shall be listed on the office’s:</text> <paragraph num="(1)"> <text>Consent to treatment form signed by the patient; or</text> </paragraph> <paragraph num="(2)"> <text>Informed consent protocol.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Chiropractic Assistants with X-ray Privileges."> <paragraph num="A."> <text>A chiropractic assistant may perform the duties of a chiropractic assistant with X-ray privileges only as directed by a supervising chiropractor.</text> </paragraph> <paragraph num="B."> <text>A chiropractic assistant, with or without X-ray privileges, may not:</text> <paragraph num="(1)"> <text>Provide oral or written diagnosis; or</text> </paragraph> <paragraph num="(2)"> <text>Work independently.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A chiropractic assistant may perform X-rays only after the completion of:</text> <paragraph num="(1)"> <text>60 hours of didactic training in a Board-approved course of instruction that includes:</text> <paragraph num="(a)"> <text>Radiation physics;</text> </paragraph> <paragraph num="(b)"> <text>Radiation biology;</text> </paragraph> <paragraph num="(c)"> <text>Radiation protection;</text> </paragraph> <paragraph num="(d)"> <text>Imaging principles in radiation exposure;</text> </paragraph> <paragraph num="(e)"> <text>Patient preparation and positioning;</text> </paragraph> <paragraph num="(f)"> <text>Human anatomy and physiology; and</text> </paragraph> <paragraph num="(g)"> <text>Emergency procedures; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>46 X-ray studies under the direct supervision of a supervising chiropractor that include:</text> <paragraph num="(a)"> <text>10 cervical series which include at least one of each of the following views:</text> <paragraph num="(i)"> <text>Anterior to posterior;</text> </paragraph> <paragraph num="(ii)"> <text>Lateral;</text> </paragraph> <paragraph num="(iii)"> <text>Anterior to posterior open mouth;</text> </paragraph> <paragraph num="(iv)"> <text>Flexion;</text> </paragraph> <paragraph num="(v)"> <text>Extension; and</text> </paragraph> <paragraph num="(vi)"> <text>Oblique;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>6 thoracic series which include at least one of each of the following views:</text> <paragraph num="(i)"> <text>Anterior to posterior;</text> </paragraph> <paragraph num="(ii)"> <text>Lateral;</text> </paragraph> <paragraph num="(iii)"> <text>Flexion; and</text> </paragraph> <paragraph num="(iv)"> <text>Extension;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>10 lumbar series which include at least one of each of the following views:</text> <paragraph num="(i)"> <text>Anterior to posterior;</text> </paragraph> <paragraph num="(ii)"> <text>Lateral;</text> </paragraph> <paragraph num="(iii)"> <text>Flexion;</text> </paragraph> <paragraph num="(iv)"> <text>Extension; and</text> </paragraph> <paragraph num="(v)"> <text>Oblique; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>20 extremity views which include at least one of each of the following:</text> <paragraph num="(i)"> <text>Shoulder;</text> </paragraph> <paragraph num="(ii)"> <text>Elbow;</text> </paragraph> <paragraph num="(iii)"> <text>Wrist;</text> </paragraph> <paragraph num="(iv)"> <text>Hand;</text> </paragraph> <paragraph num="(v)"> <text>Ribs;</text> </paragraph> <paragraph num="(vi)"> <text>Hip;</text> </paragraph> <paragraph num="(vii)"> <text>Knee;</text> </paragraph> <paragraph num="(viii)"> <text>Ankle; and</text> </paragraph> <paragraph num="(ix)"> <text>Foot.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Term and Renewal of Registration."> <paragraph num="A."> <text>A registration expires every 2 years, unless the registration is renewed for a 2-year term.</text> </paragraph> <paragraph num="B."> <text>Before a registration expires, the registrant periodically may renew it for another term if the registrant:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be registered;</text> </paragraph> <paragraph num="(2)"> <text>Pays a renewal fee as set forth in COMAR 10.43.06;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(4)"> <text>Submits to the Board verification of at least 10 hours of continuing education in courses approved by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place a registration holder on inactive status if the registration holder submits to the Board the:</text> <paragraph num="(1)"> <text>Completed application for inactive status on the form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Biennial fee for inactive status as specified in COMAR 10.43.06.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The registration holder on inactive status:</text> <paragraph num="(1)"> <text>Is not entitled to practice chiropractic until the registration is reactivated; and</text> </paragraph> <paragraph num="(2)"> <text>May reactivate the registration at any time if the:</text> <paragraph num="(a)"> <text>Application for reactivation is completed; and</text> </paragraph> <paragraph num="(b)"> <text>Reactivation fee is paid as set forth in COMAR 10.43.06.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Nonrenewed Status."> <paragraph num="A."> <text>The Board shall place a registration holder in a nonrenewed status if the registration holder fails to complete an application for:</text> <paragraph num="(1)"> <text>Registration renewal during the biennial cycle; or</text> </paragraph> <paragraph num="(2)"> <text>Inactive status during the renewal cycle.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The registration holder may reinstate a nonrenewed status for registration within 5 years of the expiration date of the last active registration.</text> </paragraph> <paragraph num="C."> <text>If the expired registration holder is on nonrenewed status for more than 5 years, the holder shall:</text> <paragraph num="(1)"> <text>Reapply; and</text> </paragraph> <paragraph num="(2)"> <text>Meet all of the requirements set forth in this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Practicing Without Registration."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, a person may not practice, attempt to practice, or offer to practice as a chiropractic assistant in this State unless registered by the Board.</text> </paragraph> <paragraph num="B."> <text>A person may not serve as a chiropractic applicant or assistant unless approved by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Penalties for Violations of This Chapter."> <paragraph num="A."> <text>Violations of these regulations may result in disciplinary action against the supervising chiropractor as set forth in Health Occupations Article, §3-313, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A person practicing as a chiropractic assistant without being registered, except as provided in these regulations, is guilty of a misdemeanor, and may be fined $5,000 or imprisoned for 1 year, or both.</text> </paragraph> <paragraph num="C."> <text>A chiropractic assistant and an applicant for registration is subject to the Board's disciplinary authority under Health Occupations Article, §3-313, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Display of Registration."> <text>A chiropractic assistant shall display the registration and any current renewal registration conspicuously in the space where the license holder is engaged in practice, including in any temporary space, or in any exhibit location.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Notification of Change of Address."> <text>A registered chiropractic assistant shall notify the Board of any change in the name or address of the chiropractic assistant, in writing, within 60 days after the change occurs.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-205, 3-302.1, and 3-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 9, 1994 (21:9 Md. R. 751)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, C amended effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09H amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Subtitle name amended to be, Board of Chiropractic Examiners, Chiropractic Assistants, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective July 2, 2018 (45:13 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09P amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 30, 2019 (46:26 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> </annotations> </chapter> <chapter num="08" heading="Licensure and Registration Examination — Special Needs Applicants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish the procedures to be followed by examination applicants who have special needs because of a handicap or religious convictions.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility Requirements."> <paragraph num="A."> <text>An applicant with a disability may request modifications in examination materials or procedures by making a written request to the Board that includes:</text> <paragraph num="(1)"> <text>The applicant's name;</text> </paragraph> <paragraph num="(2)"> <text>The date of the examination to be modified;</text> </paragraph> <paragraph num="(3)"> <text>A letter from the appropriate medical professional that:</text> <paragraph num="(a)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(b)"> <text>Provides information describing the accommodations required; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A letter from the applicant's education program, indicating what modifications, if any, were granted by the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall send the request for modification and supporting documentation to the Board by the application deadline.</text> </paragraph> <paragraph num="C."> <text>The Board reserves the right to review each special needs application and evaluate each on its individual merit.</text> </paragraph> <paragraph num="D."> <text>The applicant may be required to bear the cost of special arrangements or procedures to accommodate the applicant's special needs.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-205 and 3-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 26, 1992 (19:21 Md. R. 1892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 24, 2000 (27:1 Md. R. 77)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 6, 2001 (28:15 Md. R. 1398)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 24, 2000 (27:1 Md. R. 77)</annotation> <annotation type="History" subtype="Administrative History">Subtitle and Chapter name amended to be, Board of Chiropractic Examiners, Licensure and Registration Examination — Special Needs Applicants, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="09" heading="Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of penalties not exceeding $5,000 against any chiropractor in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §3-313, Annotated Code of Maryland, to suspend or revoke a license.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“License” means a license issued by the Board to practice chiropractic or to practice chiropractic with the right to practice physical therapy.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means a chiropractor who is licensed by the Board to practice chiropractic or to practice chiropractic with the right to practice physical therapy.</text> </paragraph> <paragraph num="(4)"> <text>“Penalty” means monetary penalty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty — General."> <paragraph num="A."> <text>Imposition of a Penalty After a Hearing. If, after a hearing under Health Occupations Article, §3-315, Annotated Code of Maryland, the Board finds that there are grounds under Health Occupations Article, §3-313, to suspend or revoke a license, the Board may impose a penalty of not more than $5,000:</text> <paragraph num="(1)"> <text>Instead of, or in addition to, suspending the license; or</text> </paragraph> <paragraph num="(2)"> <text>In addition to revoking the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Imposition of a Penalty Without a Hearing. If, after disciplinary procedures have been brought against a licensee, the licensee waives the right to a hearing required under this subtitle, and if the Board finds that there are grounds under Health Occupations Article, §3-313, Annotated Code of Maryland, to reprimand the licensee, place the licensee on probation, or suspend or revoke a license, the Board may impose a penalty not exceeding $5,000 for each violation in addition to reprimanding, placing the licensee on probation, or suspending or revoking the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Imposition of a Penalty on a Chiropractor."> <paragraph num="A."> <text>The Board may impose a penalty of not less than $100 or more than $2,000 on a chiropractor found guilty of any of the following, if the chiropractor:</text> <paragraph num="(1)"> <text>Willfully fails to file or record a report as required by law; or</text> </paragraph> <paragraph num="(2)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may impose a penalty of not less than $300 or more than $3,500 on a chiropractor found guilty of any of the following, if the chiropractor:</text> <paragraph num="(1)"> <text>Practices chiropractic under a false name or trade name;</text> </paragraph> <paragraph num="(2)"> <text>Provides professional services while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts, or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Solicits or advertises in a false or misleading manner, or in any other manner not approved by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Abandons a patient;</text> </paragraph> <paragraph num="(5)"> <text>Misrepresents the effectiveness of any treatment, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="(6)"> <text>Willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="(7)"> <text>Pays or agrees to pay a sum to an individual for bringing or referring a patient; or</text> </paragraph> <paragraph num="(8)"> <text>Violates any rule or regulation adopted by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may impose a penalty of not less than $500 or more than $5,000 on a chiropractor found guilty of any of the following:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or licensee, or for another;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively using a license;</text> </paragraph> <paragraph num="(3)"> <text>Impersonating another practitioner;</text> </paragraph> <paragraph num="(4)"> <text>Having been convicted of or pleading guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(5)"> <text>Unethically conducting the practice of chiropractic;</text> </paragraph> <paragraph num="(6)"> <text>Being professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="(7)"> <text>Grossly and willfully:</text> <paragraph num="(a)"> <text>Overcharging for professional services; or</text> </paragraph> <paragraph num="(b)"> <text>Submitting false statements to collect fees for which services are not provided;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Having been disciplined by a licensing or disciplinary authority of any other state or country or convicted by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §3-313, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Practicing chiropractic with an unauthorized individual or supervising or aiding an unauthorized individual in the practice of chiropractic;</text> </paragraph> <paragraph num="(10)"> <text>Behaving immorally in the practice of chiropractic; or</text> </paragraph> <paragraph num="(11)"> <text>Committing an act of unprofessional conduct in the practice of chiropractic.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Factors to be Considered in the Assessment of a Penalty."> <text>In those cases in which the Board determines that the imposition of a penalty is appropriate, the Board shall take into consideration the following factors, without limitations, in determining the amount of penalty:</text> <paragraph num="A."> <text>The extent to which the chiropractor derived any financial benefit from unprofessional or improper conduct;</text> </paragraph> <paragraph num="B."> <text>The willfulness of the unprofessional or improper conduct;</text> </paragraph> <paragraph num="C."> <text>The extent of actual or potential public harm caused by the unprofessional or improper conduct; and</text> </paragraph> <paragraph num="D."> <text>The cost of investigating and prosecuting the case against the chiropractor.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of a Penalty."> <paragraph num="A."> <text>A chiropractor shall pay to the Board a penalty imposed under these regulations as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-215, Annotated Code of Maryland, or Health Occupations Article, §3-316, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board pursuant to these regulations.</text> </paragraph> <paragraph num="C."> <text>If a chiropractor fails to pay, in whole or in part, a penalty imposed by the Board pursuant to these regulations, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Fiscal Planning to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected pursuant to these regulations into the State's General Fund.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §3-314, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.10 to COMAR 10.43.09, Board of Chiropractic Examiners, Monetary Penalties, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="10" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs continuing education for all individuals licensed to practice chiropractic or registered to practice as a chiropractic assistant in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Credit hour” means 1 course or program hour.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means a chiropractor licensed by the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Pre-approved provider” means:</text> <paragraph num="(a)"> <text>The State Chiropractic Association;</text> </paragraph> <paragraph num="(b)"> <text>The American Chiropractic Association;</text> </paragraph> <paragraph num="(c)"> <text>The International Chiropractors Association;</text> </paragraph> <paragraph num="(d)"> <text>Schools or colleges accredited by the Council on Chiropractic Education (CCE), the Federation of Chiropractic Licensing Boards Providers of Approved Continuing Education (FCLB PACE), and the National Board of Chiropractic Examiners (NBCE);</text> </paragraph> <paragraph num="(e)"> <text>Agencies approved by the Board of Physicians; or</text> </paragraph> <paragraph num="(f)"> <text>Schools and organizations approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Provider” means an individual or group who designs and develops continuing education courses or programs.</text> </paragraph> <paragraph num="(6)"> <text>“Registrant” means a chiropractic assistant who is registered by the Board to perform duties authorized under COMAR 10.43.07.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Renewal Requirements."> <paragraph num="A."> <text>License Renewal.</text> <paragraph num="(1)"> <text>A licensee shall satisfactorily complete 48 hours of continuing education in the 2-year period before each renewal and provide verification to the Board if requested.</text> </paragraph> <paragraph num="(2)"> <text>The licensee shall:</text> <paragraph num="(a)"> <text>Obtain a minimum of:</text> <paragraph num="(i)"> <text>3 hours in approved communicable-disease education, which includes AIDS/HIV, and sanitary procedures;</text> </paragraph> <paragraph num="(ii)"> <text>1 hour in diversity or cultural competency education;</text> </paragraph> <paragraph num="(iii)"> <text>3 hours in risk management; and</text> </paragraph> <paragraph num="(iv)"> <text>1 hour in professional ethics or jurisprudence;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Pay a renewal fee as set forth in COMAR 10.43.06; and</text> </paragraph> <paragraph num="(c)"> <text>Submit to the Board a renewal application accompanied by a continuing education form that the Board requires.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Registration Renewal.</text> <paragraph num="(1)"> <text>A registrant shall satisfactorily complete 10 hours of continuing education in the 2-year period before each renewal and provide verification to the Board, if requested.</text> </paragraph> <paragraph num="(2)"> <text>The registrant shall:</text> <paragraph num="(a)"> <text>Pay a renewal fee as set forth in COMAR 10.43.06; and</text> </paragraph> <paragraph num="(b)"> <text>Submit to the Board a renewal application accompanied by a continuing education form that the Board requires.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Hours may be in-person, home study, or online format.</text> </paragraph> <paragraph num="D."> <text>Exemptions, Waivers, and Extensions.</text> <paragraph num="(1)"> <text>Individuals issued initial licensure or registration within 12 months of the renewal date are exempt from the continuing education (CEU) requirements under this chapter for the first renewal cycle.</text> </paragraph> <paragraph num="(2)"> <text>Licensees and registrants with documented hardships seeking an exemption, waiver, or extension from CEU requirements under this chapter shall petition the Board in writing at least 90 days before the renewal date.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall review the petition for an exemption, waiver, or extension, and respond in writing to the licensee or registrant within 30 days of the Board’s decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may deny the license or registration renewal of any chiropractor or chiropractic assistant who fails to comply with this chapter.</text> </paragraph> <paragraph num="F."> <text>The Board shall conduct an audit of licensees and registrants before or during the renewal period to ensure compliance with this chapter.</text> </paragraph> <paragraph num="G."> <text>Continuing education hours may not be carried over from one renewal period to the next.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Accreditation and Approval of Continuing Education."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Base accreditation and approval of continuing education courses and programs on their content and instructor qualifications; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that continuing education courses and programs are directed toward improvement, advancement, and extension of professional skill and knowledge related to chiropractic.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Pre-Approved Providers.</text> <paragraph num="(1)"> <text>Pre-approved providers shall submit continuing education courses or programs to the Board within 30 days before commencement of the course or program date.</text> </paragraph> <paragraph num="(2)"> <text>A course or program conducted by a pre-approved provider is considered approved without further review, provided that the course or program meets the subject-matter requirements of §D of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall post the list of pre-approved providers on the Board's website for public view.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Non-Pre-Approved Providers.</text> <paragraph num="(1)"> <text>Non-pre-approved providers shall submit continuing education courses or programs to the Board 60 days prior to commencement of course or program date for review.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall formally respond to submittals in a timely manner.</text> </paragraph> <paragraph num="(3)"> <text>The process for submission for approval shall be published on the Board’s website.</text> </paragraph> <paragraph num="(4)"> <text>The Board shall post the list of approved courses or programs from non-pre-approved providers on the Board's website for public view.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For license renewal credit, the Board may approve a course or program consisting of one of the following subjects or a combination of these subjects:</text> <paragraph num="(1)"> <text>Chiropractic principles and adjusting techniques;</text> </paragraph> <paragraph num="(2)"> <text>Chiropractic ethics and jurisprudence;</text> </paragraph> <paragraph num="(3)"> <text>X-ray quality assurance program;</text> </paragraph> <paragraph num="(4)"> <text>Diagnostic imaging;</text> </paragraph> <paragraph num="(5)"> <text>Physical diagnosis;</text> </paragraph> <paragraph num="(6)"> <text>Clinical laboratory diagnosis;</text> </paragraph> <paragraph num="(7)"> <text>Orthopedic diagnosis;</text> </paragraph> <paragraph num="(8)"> <text>Neurological diagnosis;</text> </paragraph> <paragraph num="(9)"> <text>Rehabilitative procedures;</text> </paragraph> <paragraph num="(10)"> <text>Nutritional diagnosis;</text> </paragraph> <paragraph num="(11)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(12)"> <text>Risk management;</text> </paragraph> <paragraph num="(13)"> <text>Cultural competency or diversity awareness; or</text> </paragraph> <paragraph num="(14)"> <text>A subject with clinical application approved by the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Term of Approval.</text> <paragraph num="(1)"> <text>The Board shall approve a course or program for a period of 5 years.</text> </paragraph> <paragraph num="(2)"> <text>At the expiration of the 5-year approval period, the provider:</text> <paragraph num="(a)"> <text>May resubmit the course or program; and</text> </paragraph> <paragraph num="(b)"> <text>Shall meet the approval requirements of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A licensee may:</text> <paragraph num="(1)"> <text>Submit a request for review of continuing education from the Board if the:</text> <paragraph num="(a)"> <text>Continuing education is not already approved or disapproved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Licensee submits a request to the Board at least 60 days prior to the commencement of the course or program containing, but not exclusive to, information set forth in this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Achieve up to 12 hours for verified participation as an instructor, volunteer, or mentor under structured, sponsored courses or programs reviewed and approved by the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A continuing education processing review fee shall be paid in accordance with COMAR 10.43.06.02.</text> </paragraph> <paragraph num="H."> <text>A continuing education course may not exceed 12 hours during any renewal period.</text> </paragraph> <paragraph num="I."> <text>In addition to the required hours of continuing education set forth in this chapter, a licensee or registrant shall maintain a current CPR certification at the healthcare provider level from a Board-approved CPR provider for each renewal period.</text> </paragraph> <paragraph num="J."> <text>Approved credits are not transferable and are acceptable toward fulfillment of the continuing education requirement only in the renewal period in which the approved credits are earned.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Substantiation of Credits."> <paragraph num="A."> <text>The licensee or registrant shall keep accurate records of attendance at approved continuing education courses or programs and be able to substantiate those records upon request.</text> </paragraph> <paragraph num="B."> <text>The Board shall conduct a random audit before or during the license or registration renewal period to ensure compliance with this chapter.</text> </paragraph> <paragraph num="C."> <text>The Board shall disallow the continuing education credits for a licensee or registrant who is unable to substantiate the credits and may deny the license or registration renewal if credits are disallowed.</text> </paragraph> <paragraph num="D."> <text>The Board may require additional verification for any information received regarding content and certification of, and attendance at, a continuing education course or program.</text> </paragraph> <paragraph num="E."> <text>The Board may grant an extension of time for the licensee or registrant to obtain required continuing education credits if the licensee or registrant presents evidence satisfactory to the Board that failure to comply was due to circumstances beyond the licensee's or registrant’s control.</text> </paragraph> <paragraph num="F."> <text>The Board may not accept continuing education credits from a previous renewal period.</text> </paragraph> <paragraph num="G."> <text>The Board shall renew a license or registration for the first renewal period following the issuance of the original license or registration without requiring continuing education credits if the original license or registration was issued 1 year or less before the expiration date of the license or registration.</text> </paragraph> <paragraph num="H."> <text>A licensee or registrant shall maintain complete and accurate records of the licensee's or registrant’s continuing education credits for the preceding 4 years and present them to the Board upon request.</text> </paragraph> <paragraph num="I."> <text>Upon licensee or registrant petition, the Board may waive the continuing education requirements when it determines that the licensee or registrant was unable to comply due to hardship.</text> </paragraph> <paragraph num="J."> <text>The Board may institute disciplinary action, pursuant to Health Occupations Article, §3-313, Annotated Code of Maryland, against a chiropractor or chiropractic assistant who submits fraudulent information to the Board.</text> </paragraph> <paragraph num="K."> <text>Failure to substantiate continuing education hours if requested by the Board shall result in denial of:</text> <paragraph num="(1)"> <text>License or registration renewal; or</text> </paragraph> <paragraph num="(2)"> <text>Reinstatement of a license or registration.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reinstatement Requirements."> <paragraph num="A."> <text>A licensee shall satisfactorily complete a minimum of 48 continuing education hours as set forth under Regulation .03A(2)(a) of this chapter in the 2-year period immediately preceding reinstatement.</text> </paragraph> <paragraph num="B."> <text>A registrant shall satisfactorily complete a minimum of 10 continuing education hours as set forth under Regulation .03B of this chapter in the 2-year period immediately preceding reinstatement.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-308 and 3-313, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 9, 1998 (25:5 Md. R. 370)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 9, 2003 (30:11 Md. R. 735); June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 6, 2001 (28:15 Md. R. 1398); June 9, 2003 (30:11 Md. R. 735); October 22, 2007 (34:21 Md. R. 1915); June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 6, 2001 (28:15 Md. R. 1398); June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.11 to COMAR 10.43.10, Board of Chiropractic Examiners, Continuing Education Requirements, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 8, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 2, 2017 (43:26 Md. R. 1446); January 8, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 8, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 8, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 8, 2024 (50:26 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective January 8, 2024 (50:26 Md. R. 1132)</annotation> </annotations> </chapter> <chapter num="11" heading="Licensure Examination"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the requirements for licensure by examination for all applicants, except applicants who qualify for licensure under Health Occupations Article, §3-305, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited college” means a chiropractic school approved by the Council on Chiropractic Education, or its successor, and approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Letter of admission” means a document sent by the Board to the applicant approving the applicant's request to take the licensure examination.</text> </paragraph> <paragraph num="(4)"> <text>“Maryland Board examination” means the jurisprudence examination administered by the Board to measure competency under Health Occupations Article, Title 3, Annotated Code of Maryland, and COMAR 10.43.01 — .19.</text> </paragraph> <paragraph num="(5)"> <text>“National Board examination” means the written tests administered by the National Board of Chiropractic Examiners to measure competency in chiropractic.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Examination and Licensure."> <paragraph num="A."> <text>An individual is eligible to take the Maryland Board examination for licensure if the individual submits documentation, postmarked at least 45 days before the examination, verifying that the individual has:</text> <paragraph num="(1)"> <text>Been awarded a bachelor's degree from a Board-recognized, accredited college;</text> </paragraph> <paragraph num="(2)"> <text>Graduated from a college of chiropractic approved by the Board, pursuant to Health Occupations Article, §3-402, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Successfully completed parts one and two of the National Board examination with a passing score established by the National Board of Chiropractic Examiners, and all other parts with a passing score of at least 75 percent;</text> </paragraph> <paragraph num="(4)"> <text>Obtained certification in CPR at the Health Care Provider level;</text> </paragraph> <paragraph num="(5)"> <text>Provided two letters of reference attesting to the applicant's good moral character;</text> </paragraph> <paragraph num="(6)"> <text>Certified or affirmed that the individual has not practiced chiropractic without a license in the State;</text> </paragraph> <paragraph num="(7)"> <text>Filed an application and paid the required application fee as specified in COMAR 10.43.06;</text> </paragraph> <paragraph num="(8)"> <text>Paid the required examination fee as specified in COMAR 10.43.06; and</text> </paragraph> <paragraph num="(9)"> <text>Completed a State and national criminal history records check in accordance with Health Occupations Article, §3–302.1, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not refund an application fee.</text> </paragraph> <paragraph num="C."> <text>The Board shall refund the examination fee to an applicant whom the Board determines is not qualified to take the examination.</text> </paragraph> <paragraph num="D."> <text>The Board shall send to an approved applicant a letter of admission to the examination.</text> </paragraph> <paragraph num="E."> <text>The Board may refund examination fees to an applicant unable to be present for the examination if the applicant submits verification of hardship and a written request for a refund.</text> </paragraph> <paragraph num="F."> <text>The Board may not issue a license or registration if the criminal history records information required under §A(9) of this regulation has not been received.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Physical Therapy Privileges."> <text>An applicant seeking physical therapy privileges shall have obtained:</text> <paragraph num="A."> <text>Clinical and didactic education in PT modalities from an accredited institution of higher education; and</text> </paragraph> <paragraph num="B."> <text>A minimum score of 75 percent on the National Board Physiotherapy Examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Examination Misconduct."> <text>After a hearing, the Board may permanently deny licensure to an applicant found to have cheated on or subverted an examination taken to qualify for Maryland licensure.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-202, 3-205, and 3-301—3-304, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 9, 1998 (25:5 Md. R. 370)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 9, 2003 (30:11 Md. R. 735); June 13, 2011 (38:12 Md. R. 705); January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective August 6, 2001 (28:15 Md. R. 1398); June 9, 2003 (30:11 Md. R. 735); October 22, 2007 (34:21 Md. R. 1915); June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 6, 2001 (28:15 Md. R. 1398); June 9, 2003 (30:11 Md. R. 735)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.12 to COMAR 10.43.11, Board of Chiropractic Examiners, Licensure Examination, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="12" heading="Procedures for Clinical Demonstrations in Public Places"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs all chiropractic clinical demonstrations in public places by licensed chiropractors in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Chiropractic display facility” means an area where chiropractic procedures are demonstrated.</text> </paragraph> <paragraph num="(2)"> <text>“Chiropractic procedure” means examinations, mensurations, analyses, evaluations, screenings, or clinical determinations related to the practice of chiropractic in a public place.</text> </paragraph> <paragraph num="(3)"> <text>“Cursory postural screening” means a visualization, by a licensed chiropractor, of an individual's posture to detect possible structural deviations.</text> </paragraph> <paragraph num="(4)"> <text>“Demonstration” means performing chiropractic procedures in public places.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Chiropractic Demonstrations in Public Places."> <paragraph num="A."> <text>When performing chiropractic procedures in a public place, the chiropractor shall:</text> <paragraph num="(1)"> <text>Prominently display the chiropractor's current license;</text> </paragraph> <paragraph num="(2)"> <text>Provide adequate facilities for patients to disrobe in privacy;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the patient is properly draped for examination; and</text> </paragraph> <paragraph num="(4)"> <text>Maintain the privacy of the patient at all times.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The chiropractor may perform a cursory postural screening while the patient is fully clothed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Chiropractic Display Facilities in Public Places."> <text>For procedures that require partial or complete disrobing of the patient, the chiropractor shall ensure that the chiropractic display facility provides sufficient patient privacy.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Prohibitions."> <text>An unlicensed individual may not perform chiropractic procedures in public places.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Exceptions."> <text>This chapter does not preclude a salesperson from demonstrating chiropractic equipment during a convention or educational seminar.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Penalty."> <text>The Board may initiate disciplinary proceedings, pursuant to Health Occupations Article, §3-313, Annotated Code of Maryland, against a chiropractor found in violation of this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §3-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 4, 1996 (23:22 Md. R. 1497)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.13 to COMAR 10.43.12, Board of Chiropractic Examiners, Procedures for Clinical Demonstrations in Public Places, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="13" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to licensed chiropractors and registered chiropractic assistants.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Chiropractic assistant” means an individual who is registered by the Board to perform the duties authorized under COMAR 10.43.07.</text> </paragraph> <paragraph num="(2)"> <text>“Chiropractor” means an individual licensed by the Board:</text> <paragraph num="(a)"> <text>To practice chiropractic; or</text> </paragraph> <paragraph num="(b)"> <text>To practice chiropractic with the right to practice physical therapy.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Non-bona-fide treatment” means when a chiropractor or chiropractic assistant treats or examines a patient in a way that involves sexual contact, but there is no medical reason for the procedure, or the procedure falls outside the scope of reasonable chiropractic practices.</text> </paragraph> <paragraph num="(4)"> <text>“Sexually exploitative relationship” means when sexual contact occurs in an existing therapeutic relationship or within a period of time after formal termination of the relationship when the patient may still be vulnerable to the power imbalance that exists in the practitioner-patient relationship, even if the relationship may appear to be or is mutually consensual.</text> </paragraph> <paragraph num="(5)"> <text>“Therapeutic deception” means when a chiropractor or chiropractic assistant misrepresents sexual conduct as a legitimate form of treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Practice."> <paragraph num="A."> <text>A chiropractor and chiropractic assistant shall concern themselves primarily with the welfare of the patient.</text> </paragraph> <paragraph num="B."> <text>A chiropractor or chiropractic assistant who suffers from a physical, mental, or emotional impairment, including chemical abuse, that impacts the individual's ability to practice chiropractic or provide chiropractic assistance shall seek professional treatment and refrain from the practice of chiropractic or the practice of chiropractic assistance until the impairment no longer exists or reasonable accommodations can be made.</text> </paragraph> <paragraph num="C."> <text>A chiropractor and chiropractic assistant shall:</text> <paragraph num="(1)"> <text>Use professional discretion and integrity in relationships with a member of the health care community;</text> </paragraph> <paragraph num="(2)"> <text>Be professional in conduct, with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Remain free from conflict of interest while fulfilling the objectives and maintaining the integrity of the chiropractic profession;</text> </paragraph> <paragraph num="(4)"> <text>Provide accurate fee information to the patient, the individual responsible for payment for treatment, and the insurer;</text> </paragraph> <paragraph num="(5)"> <text>At all times respect the patient's dignity, autonomy, and privacy;</text> </paragraph> <paragraph num="(6)"> <text>Practice chiropractic only as defined in the scope of practice set forth in Health Occupations Article, §3-101(f) and (g), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Provide chiropractic assistance only within the parameters set forth in Health Occupations Article, §3-404, Annotated Code of Maryland, and COMAR 10.43.07;</text> </paragraph> <paragraph num="(8)"> <text>Cooperate with any lawful investigation conducted by the Board, including:</text> <paragraph num="(a)"> <text>Furnishing information requested in a timely manner as directed by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Complying with a subpoena;</text> </paragraph> <paragraph num="(c)"> <text>Responding to a complaint at the request of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Providing meaningful and timely access to relevant patient records; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Report to the Board, or other appropriate authority, conduct in the practice of chiropractic that indicates a violation of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 3, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Any other law, including but not limited to aiding or abetting the unauthorized practice of chiropractic.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A chiropractor or chiropractic assistant may not:</text> <paragraph num="(1)"> <text>Misrepresent credentials, qualifications, or affiliations and shall attempt to correct others who misrepresent the chiropractor's or the chiropractic assistant's credentials, qualifications, or affiliations;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly engage in or condone behavior that is fraudulent, dishonest, or deceitful, or involves moral turpitude;</text> </paragraph> <paragraph num="(3)"> <text>Engage in a commercial activity which conflicts with the duties of a chiropractor and chiropractic assistant;</text> </paragraph> <paragraph num="(4)"> <text>Perform chiropractic on a patient if a contraindication against chiropractic treatment exists;</text> </paragraph> <paragraph num="(5)"> <text>Discriminate against a patient or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability;</text> </paragraph> <paragraph num="(6)"> <text>Intimidate, threaten, influence, or attempt to influence any person regarding any violation of law or regulation; or</text> </paragraph> <paragraph num="(7)"> <text>Aid or abet any individual violating or attempting to violate any provision of law or regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Relationship with Patient."> <paragraph num="A."> <text>A chiropractor shall:</text> <paragraph num="(1)"> <text>Use professional judgment in the use of evaluation and treatment procedures;</text> </paragraph> <paragraph num="(2)"> <text>Decline to administer treatment if the chiropractor believes that a treatment is contraindicated or unjustified;</text> </paragraph> <paragraph num="(3)"> <text>Terminate a professional relationship with a patient in an appropriate manner, such as:</text> <paragraph num="(a)"> <text>Providing the patient with sufficient notice to permit the patient to obtain the services of another professional;</text> </paragraph> <paragraph num="(b)"> <text>Assisting the patient by providing referrals if appropriate; or</text> </paragraph> <paragraph num="(c)"> <text>Continuing to provide emergency treatment to the patient if treatment is required before a reasonable time has passed to allow the patient to obtain the services of another health care provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Maintain a written record of treatment of the patient under the chiropractor's care for at least:</text> <paragraph num="(a)"> <text>5 years after the termination of treatment; and</text> </paragraph> <paragraph num="(b)"> <text>5 years after the patient becomes 18 years old, if applicable;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Make the written records of treatment available to the patient upon request, in compliance with applicable laws for disclosure of medical records;</text> </paragraph> <paragraph num="(6)"> <text>Make arrangements for another professional to provide for the needs of the patient during anticipated absences when the chiropractor is unavailable to the patient;</text> </paragraph> <paragraph num="(7)"> <text>Make referrals only to other qualified and duly licensed health care providers;</text> </paragraph> <paragraph num="(8)"> <text>Accurately inform the patient, other health care professionals, and the public of the limitations of the practice of chiropractic;</text> </paragraph> <paragraph num="(9)"> <text>Adequately assess the patient to determine if contraindications against chiropractic treatment exist and refer the patient to an appropriate health care practitioner;</text> </paragraph> <paragraph num="(10)"> <text>Exercise independent professional judgment in the treatment or evaluation of the patient regardless of whether the patient was referred by another health care provider;</text> </paragraph> <paragraph num="(11)"> <text>Ensure clear and concise professional communications with patients regarding:</text> <paragraph num="(a)"> <text>Nature and duration of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(c)"> <text>Costs;</text> </paragraph> <paragraph num="(d)"> <text>Billing; and</text> </paragraph> <paragraph num="(e)"> <text>Insurance; and</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Administer fair and equitable fees to patients regardless of status or insurance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A chiropractor may not:</text> <paragraph num="(1)"> <text>Accept a client for treatment, or continue unnecessary treatment, when the patient cannot be reasonably expected to benefit from the treatment;</text> </paragraph> <paragraph num="(2)"> <text>Receive remuneration from, or provide remuneration to, or split a fee, for either making or accepting a referral of the patient to or from another health care provider;</text> </paragraph> <paragraph num="(3)"> <text>Make a guarantee or promise about the efficacy of a particular treatment, the chiropractor's practice, or the result of a treatment unless supported by scientific principles accepted by the profession; or</text> </paragraph> <paragraph num="(4)"> <text>Exploit the professional relationship by:</text> <paragraph num="(a)"> <text>Continuing treatment unnecessarily; or</text> </paragraph> <paragraph num="(b)"> <text>Charging for a service:</text> <paragraph num="(i)"> <text>Not provided; or</text> </paragraph> <paragraph num="(ii)"> <text>Different from those actually provided.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Professional Boundaries."> <paragraph num="A."> <text>A chiropractor and chiropractic assistant shall:</text> <paragraph num="(1)"> <text>Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship; and</text> </paragraph> <paragraph num="(2)"> <text>Respect and maintain professional boundaries and respect the patient's reasonable expectation of professional conduct.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A chiropractor and chiropractic assistant may not:</text> <paragraph num="(1)"> <text>Exploit a relationship with a patient, staff member, or student for the chiropractor's or chiropractic assistant's personal advantage including, but not limited to, a personal, sexual, romantic, or financial relationship;</text> </paragraph> <paragraph num="(2)"> <text>Engage in a sexually intimate act with a patient; or</text> </paragraph> <paragraph num="(3)"> <text>Engage in sexual misconduct, which includes but is not limited to:</text> <paragraph num="(a)"> <text>Therapeutic deception;</text> </paragraph> <paragraph num="(b)"> <text>Non-bona-fide treatment; and</text> </paragraph> <paragraph num="(c)"> <text>A sexually exploitative relationship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A chiropractor and chiropractic assistant may not engage in inappropriate behavior with other practice staff including sexual advances, harassment, discrimination, exploitation, retaliation, and other unprofessional conduct.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records, Confidentiality, and Informed Consent."> <text>A chiropractor shall:</text> <paragraph num="A."> <text>Respect and maintain the privacy and confidentiality of the patient;</text> </paragraph> <paragraph num="B."> <text>Disclose the patient’s records or information about the patient only:</text> <paragraph num="(1)"> <text>In accordance with the consent to treatment form signed by the:</text> <paragraph num="(a)"> <text>Patient; or</text> </paragraph> <paragraph num="(b)"> <text>Parent or guardian of a minor patient or incompetent patient; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>As required by law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Adequately safeguard confidential patient information, including storage and disposal of records;</text> </paragraph> <paragraph num="D."> <text>Provide sufficient information to a patient to allow the patient to make an informed decision regarding treatment, including:</text> <paragraph num="(1)"> <text>The purpose and nature of an evaluation or treatment regimen;</text> </paragraph> <paragraph num="(2)"> <text>Alternatives to treatment;</text> </paragraph> <paragraph num="(3)"> <text>Side effects and benefits of a treatment regimen proposed and alternatives to that treatment;</text> </paragraph> <paragraph num="(4)"> <text>The estimated cost of treatment and alternatives to treatment;</text> </paragraph> <paragraph num="(5)"> <text>The right of the patient to:</text> <paragraph num="(a)"> <text>Withdraw from treatment at any time, including the risks associated with withdrawing from treatment;</text> </paragraph> <paragraph num="(b)"> <text>Decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program; or</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Terminate any treatment contract at any time, for any or no reason, with no fee or penalty incurred;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Obtain the full informed consent of a patient participating in a human research program, without communicating a direct or implied penalty for the patient's refusal to participate in the program and with due regard for the patient's autonomy and dignity;</text> </paragraph> <paragraph num="F."> <text>Comply with applicable federal and State laws for human research programs; and</text> </paragraph> <paragraph num="G."> <text>Promptly and efficiently respond to any patient or Board request for records.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Education and Training."> <paragraph num="A."> <text>A chiropractor or chiropractic assistant shall:</text> <paragraph num="(1)"> <text>Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and</text> </paragraph> <paragraph num="(2)"> <text>Be current in the qualifications to practice, including meeting continuing education requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The chiropractor or chiropractic assistant may not perform a treatment or provide a service that the chiropractor or chiropractic assistant is not qualified to perform or which is beyond the scope of the chiropractor's or chiropractic assistant’s education, training, capabilities, experience, and scope of practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Advertising."> <paragraph num="A."> <text>A chiropractor may advertise services subject to COMAR 10.43.03.</text> </paragraph> <paragraph num="B."> <text>A chiropractor is accountable under this regulation if the chiropractor uses an agent, partnership, professional association, or health maintenance organization to implement an action prohibited by COMAR 10.43.03.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Ethical, Legal, and Professional Responsibilities."> <text>A chiropractor and chiropractic assistant may not construe any failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and generally recognized in the chiropractic profession.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Penalties."> <text>Violation of a regulation in this chapter may result in the Board taking action pursuant to Health Occupations Article, §3-313, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 3-205, and 3-313, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 9, 2000 (26:27 Md. R. 2015)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, D amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 22, 2007 (34:21 Md. R. 1915); June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G adopted effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.14 to COMAR 10.43.13, Board of Chiropractic Examiners, Code of Ethics, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> </annotations> </chapter> <chapter num="14" heading="Record Keeping"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the minimum standards for the documentation of patient care by the chiropractor.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Diagnosis” means the determination by the chiropractor of the nature and cause of a disease or injury through evaluation of patient history, examination, and review of any laboratory and radiological data.</text> </paragraph> <paragraph num="(3)"> <text>“Examination” means varied procedures such as analysis, assessment, and evaluation performed by the chiropractor to determine a diagnosis.</text> </paragraph> <paragraph num="(4)"> <text>"History" means the patient's account of past, present, and familial health.</text> </paragraph> <paragraph num="(5)"> <text>“Subjective, objective, assessment, and plan (SOAP) notes” means the written record maintained by the chiropractor of:</text> <paragraph num="(a)"> <text>The patient's qualitative or quantitative description of the patient's condition;</text> </paragraph> <paragraph num="(b)"> <text>Findings pertaining to the patient's condition based on examination and tests;</text> </paragraph> <paragraph num="(c)"> <text>The chiropractor's clinical opinion of the condition; and</text> </paragraph> <paragraph num="(d)"> <text>Instructions given to the patient, orthopedic appliances provided to the patient with instructions for usage, and recommendations for treatment, including modalities used and areas treated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Record Keeping."> <paragraph num="A."> <text>The chiropractor shall maintain accurate, detailed, legible, and organized records, documenting all data collected pertaining to the patient's health status.</text> </paragraph> <paragraph num="B."> <text>The chiropractor may not erase, alter, or conceal patient records but shall initial and date any changes made in the corresponding margin.</text> </paragraph> <paragraph num="C."> <text>The Patient Record.</text> <paragraph num="(1)"> <text>The chiropractor shall create a record for each patient.</text> </paragraph> <paragraph num="(2)"> <text>The chiropractor shall state the patient's name or identification number on each document contained in the patient record.</text> </paragraph> <paragraph num="(3)"> <text>The chiropractor shall include the following information in the patient record:</text> <paragraph num="(a)"> <text>Chiropractor and clinic name identification;</text> </paragraph> <paragraph num="(b)"> <text>Patient history;</text> </paragraph> <paragraph num="(c)"> <text>Examination findings;</text> </paragraph> <paragraph num="(d)"> <text>Diagnoses;</text> </paragraph> <paragraph num="(e)"> <text>Treatment plan;</text> </paragraph> <paragraph num="(f)"> <text>SOAP notes;</text> </paragraph> <paragraph num="(g)"> <text>Financial records;</text> </paragraph> <paragraph num="(h)"> <text>Records of telephone conversations;</text> </paragraph> <paragraph num="(i)"> <text>Copies of correspondence and reports sent to other health care providers, diagnostic facilities, and legal representatives;</text> </paragraph> <paragraph num="(j)"> <text>Records and reports provided by other health care providers and diagnostic facilities; and</text> </paragraph> <paragraph num="(k)"> <text>The signed consent to treatment form of the:</text> <paragraph num="(i)"> <text>Patient; or</text> </paragraph> <paragraph num="(ii)"> <text>Parent or guardian of a minor patient or incompetent patient.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Correspondence. The chiropractor shall identify the name of the attending chiropractor, clinic name, address, and telephone number on patient records and reports sent to another health care provider.</text> </paragraph> <paragraph num="E."> <text>Maintenance and Release of Patient Records.</text> <paragraph num="(1)"> <text>The chiropractor shall keep confidential all information contained in the patient file, in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The chiropractor shall release patient records when release is:</text> <paragraph num="(a)"> <text>Authorized by the patient in writing; or</text> </paragraph> <paragraph num="(b)"> <text>Compelled by law.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The chiropractor may assess fees for duplicating patient records for the patient or for another health care provider in accordance with Health-General Article, §4-304, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>The chiropractor shall maintain records in accordance with Health-General Article, §4-403, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Supervisory Responsibilities."> <paragraph num="A."> <text>The chiropractor is responsible for record keeping, consent to treatment forms, billing, and other patient-related documentation handled, maintained, or managed by the chiropractor’s staff.</text> </paragraph> <paragraph num="B."> <text>The chiropractor shall ensure that employees involved in the preparation, organization, and filing of records adhere to the regulations of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient History."> <text>The chiropractor shall include the following in the patient history:</text> <paragraph num="A."> <text>Personal data, including:</text> <paragraph num="(1)"> <text>Name,</text> </paragraph> <paragraph num="(2)"> <text>Address,</text> </paragraph> <paragraph num="(3)"> <text>Telephone number,</text> </paragraph> <paragraph num="(4)"> <text>Date of birth,</text> </paragraph> <paragraph num="(5)"> <text>Race,</text> </paragraph> <paragraph num="(6)"> <text>Sex, and</text> </paragraph> <paragraph num="(7)"> <text>Current occupation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Complaint or complaints, including:</text> <paragraph num="(1)"> <text>Description of the complaint or complaints,</text> </paragraph> <paragraph num="(2)"> <text>Quality and character of the complaint or complaints,</text> </paragraph> <paragraph num="(3)"> <text>Intensity,</text> </paragraph> <paragraph num="(4)"> <text>Frequency,</text> </paragraph> <paragraph num="(5)"> <text>Location,</text> </paragraph> <paragraph num="(6)"> <text>Radiation,</text> </paragraph> <paragraph num="(7)"> <text>Onset,</text> </paragraph> <paragraph num="(8)"> <text>Duration,</text> </paragraph> <paragraph num="(9)"> <text>Palliative and provocative factors, and</text> </paragraph> <paragraph num="(10)"> <text>History of present complaint or complaints;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Family health history;</text> </paragraph> <paragraph num="D."> <text>Past health history, including:</text> <paragraph num="(1)"> <text>General state of health,</text> </paragraph> <paragraph num="(2)"> <text>Previous illnesses,</text> </paragraph> <paragraph num="(3)"> <text>Surgical history,</text> </paragraph> <paragraph num="(4)"> <text>Previous injuries,</text> </paragraph> <paragraph num="(5)"> <text>Hospitalizations,</text> </paragraph> <paragraph num="(6)"> <text>Previous treatment and diagnostic testing,</text> </paragraph> <paragraph num="(7)"> <text>Prescribed and nonprescribed medications and supplements,</text> </paragraph> <paragraph num="(8)"> <text>Allergies, and</text> </paragraph> <paragraph num="(9)"> <text>Mental illness;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Systems review, including:</text> <paragraph num="(1)"> <text>Musculoskeletal,</text> </paragraph> <paragraph num="(2)"> <text>Cardiovascular,</text> </paragraph> <paragraph num="(3)"> <text>Respiratory,</text> </paragraph> <paragraph num="(4)"> <text>Gastrointestinal,</text> </paragraph> <paragraph num="(5)"> <text>Neurological,</text> </paragraph> <paragraph num="(6)"> <text>Ophthalmological,</text> </paragraph> <paragraph num="(7)"> <text>Otolaryngological,</text> </paragraph> <paragraph num="(8)"> <text>Endocrine,</text> </paragraph> <paragraph num="(9)"> <text>Peripheral vascular, and</text> </paragraph> <paragraph num="(10)"> <text>Psychiatric; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Personal history, including:</text> <paragraph num="(1)"> <text>Occupational,</text> </paragraph> <paragraph num="(2)"> <text>Activities,</text> </paragraph> <paragraph num="(3)"> <text>Exercise, and</text> </paragraph> <paragraph num="(4)"> <text>Health habits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalties."> <text>Violation of this chapter may result in disciplinary action against the chiropractor, as set forth in Health Occupations Article, §3-313, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §3-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 23, 1998 (25:4 Md. R. 244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 22, 2007 (34:21 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Chapter and Subtitle renamed and recodified from COMAR 10.43.15 to COMAR 10.43.14, Board of Chiropractic Examiners, Record Keeping, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> </annotations> </chapter> <chapter num="15" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter shall be used by the Board and the Maryland Office of Administrative Hearings as a framework for imposing discipline.</text> </paragraph> <paragraph num="B."> <text>The Board and the Maryland Office of Administrative Hearings shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation.</text> </paragraph> <paragraph num="C."> <text>The Board shall complete a worksheet for each complaint considered by the Board that is not initially closed.</text> </paragraph> <paragraph num="D."> <text>The Board is aware that there may be conduct by a licensee that does not fall squarely within a particular guideline contained in Regulation .06 of this chapter. In that event the Board will so indicate on the worksheet and use its best judgment to determine the appropriate sanction.</text> </paragraph> <paragraph num="E."> <text>The Board and the Maryland Office of Administrative Hearings shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Conditions” means requirements in a public or nonpublic order that a licensee is required to satisfy which include but are not limited to:</text> <paragraph num="(a)"> <text>Treatment and counseling for an emotional or physical illness;</text> </paragraph> <paragraph num="(b)"> <text>Submission to drug and alcohol testing;</text> </paragraph> <paragraph num="(c)"> <text>Abstinence from specified drugs;</text> </paragraph> <paragraph num="(d)"> <text>Abstinence from alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Remedial training;</text> </paragraph> <paragraph num="(f)"> <text>Inspection;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring;</text> </paragraph> <paragraph num="(h)"> <text>Evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(j)"> <text>Testing of clinical skills;</text> </paragraph> <paragraph num="(k)"> <text>Submission of written reports;</text> </paragraph> <paragraph num="(l)"> <text>A demonstration of knowledge or competency;</text> </paragraph> <paragraph num="(m)"> <text>Limitation of practice;</text> </paragraph> <paragraph num="(n)"> <text>Limitation on the administration of specified drugs to patients;</text> </paragraph> <paragraph num="(o)"> <text>The provision of pro bono chiropractic to the poor, elderly, or disabled;</text> </paragraph> <paragraph num="(p)"> <text>Obeyance of Maryland Chiropractic Act, federal, state, and local laws; and</text> </paragraph> <paragraph num="(q)"> <text>The payment of a civil penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Conduct” means behavior or action or a failure to behave or act that results in a violation of the Maryland Chiropractic Act or the regulations adopted by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees in formal and informal actions and proceedings.</text> </paragraph> <paragraph num="B."> <text>Except as provided in Regulation .05 of this chapter, the Board shall impose a sanction not less severe than the minimum listed in Regulation .06 of this chapter, nor more severe than the maximum listed in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>When conduct results in multiple violations of the Maryland Chiropractic Act and the regulations adopted by the Board, the Board shall consider sanctions that are greater than those imposed for a single violation.</text> </paragraph> <paragraph num="D."> <text>This chapter does not apply to disciplinary matters reviewed by the Board that are initially closed.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise indicated, the period of a suspension may be stayed in whole or in part.</text> </paragraph> <paragraph num="F."> <text>A respondent placed on suspension or probation shall have conditions attached to the suspension or probation which focus on the conduct and steps needed to assure public protection.</text> </paragraph> <paragraph num="G."> <text>Consent orders shall:</text> <paragraph num="(1)"> <text>Include an acknowledgement of the violation or violations; and</text> </paragraph> <paragraph num="(2)"> <text>Indicate that the respondent accepts personal responsibility for the respondent's behavior.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the conduct is not described in Regulation .06 of this chapter, the Board shall use its judgment to determine appropriate sanctions and shall so state in the sanctions worksheet.</text> </paragraph> <paragraph num="I."> <text>A departure from the sanctioning guidelines alone may not be grounds for any hearing or appeal of any Board action before the Board or the Maryland Office of Administrative Hearings.</text> </paragraph> <paragraph num="J."> <text>The sanctioning guidelines are not applicable to:</text> <paragraph num="(1)"> <text>Individuals seeking an initial license; or</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a license under State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Notwithstanding the sanctioning guidelines, a respondent may surrender a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Worksheet."> <paragraph num="A."> <text>The Board shall complete a sanctions worksheet after considering each disciplinary matter.</text> </paragraph> <paragraph num="B."> <text>The sanctions worksheet shall, at a minimum:</text> <paragraph num="(1)"> <text>Briefly summarize the conduct that constituted the violation or violations meriting action;</text> </paragraph> <paragraph num="(2)"> <text>Identify the severity of the conduct;</text> </paragraph> <paragraph num="(3)"> <text>Describe other factors that the Board considered in determining the recommended sanctions imposed including but not limited to:</text> <paragraph num="(a)"> <text>Aggravating factors as outlined in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Mitigating factors as outlined in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Prior disciplinary history; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Identify the recommended sanctions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board’s summary of the conduct that constituted the violation or violations need not:</text> <paragraph num="(1)"> <text>Be exhaustive; or</text> </paragraph> <paragraph num="(2)"> <text>Include every violation meriting action by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The existence of one or more aggravating or mitigating factors contained in Regulation .05 of this chapter does not impose on the Board any requirement to make findings of fact or to articulate its reasoning for not exercising its discretion to impose a sanction outside the range of sanctions.</text> </paragraph> <paragraph num="E."> <text>A copy of the sanctions worksheet may be obtained by the respondent or the respondent's legal representative.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Aggravating and Mitigating Factors."> <paragraph num="A."> <text>Sanctions in a particular case may fall outside the range of the sanctioning guidelines established by the Board.</text> </paragraph> <paragraph num="B."> <text>If the sanctions imposed by the Board fall outside the range of the sanctioning guidelines the Board shall state its reasons on its worksheet.</text> </paragraph> <paragraph num="C."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of the sanctioning guidelines:</text> <paragraph num="(1)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative discipline history;</text> </paragraph> <paragraph num="(b)"> <text>Whether the offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>Whether the offense has the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>Whether the offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>Whether the respondent pursued the respondent's financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was especially vulnerable;</text> </paragraph> <paragraph num="(g)"> <text>Whether the respondent attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(h)"> <text>Whether the respondent:</text> <paragraph num="(i)"> <text>Concealed, falsified, or destroyed evidence; or</text> </paragraph> <paragraph num="(ii)"> <text>Presented false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Whether the respondent willfully and without legal justification failed to cooperate with a lawful investigation conducted by the Board; and</text> </paragraph> <paragraph num="(j)"> <text>Whether previous attempts to rehabilitate the respondent were unsuccessful; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The passage of time since any prior offenses;</text> </paragraph> <paragraph num="(c)"> <text>Whether the respondent self-reported to the Board;</text> </paragraph> <paragraph num="(d)"> <text>Cooperation with the Board’s investigation;</text> </paragraph> <paragraph num="(e)"> <text>Full disclosure to the Board;</text> </paragraph> <paragraph num="(f)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(g)"> <text>Timely good-faith efforts to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(i)"> <text>Absence of premeditation to commit the offense;</text> </paragraph> <paragraph num="(j)"> <text>Absence of potential harm to the public;</text> </paragraph> <paragraph num="(k)"> <text>Absence of adverse impact;</text> </paragraph> <paragraph num="(l)"> <text>Whether the offense was an isolated incident and not likely to recur;</text> </paragraph> <paragraph num="(m)"> <text>How and when the respondent has been involved in community service and the value of the community service to the community; and</text> </paragraph> <paragraph num="(n)"> <text>Voluntary admissions of misconduct.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disciplinary Guidelines."> <text>The following guidelines shall be used by the Board as a guide for sanctioning licensees in formal and informal actions and proceedings:</text> <paragraph num="A."> <text>Abuse — Physical and Emotional.</text> </paragraph> <paragraph num="B."> <text>Criminal Convictions or Plea of Nolo Contendere.</text> </paragraph> <paragraph num="C."> <text>Disciplined by Another Licensing or Disciplinary Authority.</text> </paragraph> <paragraph num="D."> <text>Diversion of Controlled Substances or Prescription Drugs.</text> </paragraph> <paragraph num="E."> <text>Failure to Renew a License When the Licensee Has Continued to Practice.</text> </paragraph> <paragraph num="F."> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="G."> <text>Incompetent Practice Or Misconduct.</text> </paragraph> <paragraph num="H."> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="I."> <text>Substance Abuse.</text> </paragraph> <paragraph num="J."> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="K."> <text>Unethical Conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 3-313, and 3-315, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Subtitle amended and recodified from COMAR 10.43.16 to COMAR 10.43.15, Board of Chiropractic Examiners, Sanctioning Guidelines, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="16" heading="Dry Needling"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the provision of dry needling as an intervention performed by chiropractors.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Dry needling” means a chiropractic intervention, also known as intramuscular manual therapy, that:</text> <paragraph num="(a)"> <text>Is performed only by chiropractors with physical therapy privileges;</text> </paragraph> <paragraph num="(b)"> <text>Involves the insertion of one or more solid needles, a mechanical device, into the muscle and related tissues to affect change in muscle and related tissues;</text> </paragraph> <paragraph num="(c)"> <text>Requires ongoing evaluation, assessment, and re-evaluation of the impairments;</text> </paragraph> <paragraph num="(d)"> <text>Is only utilized in parts of the body with neuromuscular or musculoskeletal links to the impairments; and</text> </paragraph> <paragraph num="(e)"> <text>Is not performed for:</text> <paragraph num="(i)"> <text>The purposes of acupuncture as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Any purpose outside the scope of chiropractic.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Practice."> <paragraph num="A."> <text>A chiropractor registered to perform dry needling shall:</text> <paragraph num="(1)"> <text>Fully explain dry needling to the patient in advance of treatment;</text> </paragraph> <paragraph num="(2)"> <text>Obtain informed written consent specific to dry needling, which shall be included in the patient’s medical record;</text> </paragraph> <paragraph num="(3)"> <text>Perform dry needling in a competent manner consistent with patient health and safety; and</text> </paragraph> <paragraph num="(4)"> <text>Document the provision and the specific location of the dry needling service in accordance with the requirements of COMAR 10.43.14.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A chiropractor who performs dry needling in a manner inconsistent with the standards of practice enumerated in this regulation may be subject to discipline pursuant to COMAR 10.43.15.06.</text> </paragraph> <paragraph num="C."> <text>Dry needling is not within the scope of practice for:</text> <paragraph num="(1)"> <text>A registered chiropractic assistant;</text> </paragraph> <paragraph num="(2)"> <text>A chiropractic assistant trainee;</text> </paragraph> <paragraph num="(3)"> <text>A preceptor; or</text> </paragraph> <paragraph num="(4)"> <text>An extern.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Minimum Education and Training Required."> <paragraph num="A."> <text>A chiropractor with physical therapy privileges shall be in good standing before registering to perform dry needling.</text> </paragraph> <paragraph num="B."> <text>The Board shall accept a dry needling course completed before May 18, 2020, if:</text> <paragraph num="(1)"> <text>The same course, in substantially similar form, is sponsored by a continuing education provider approved by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>The chiropractor seeking to perform dry needling provides the Board with a certificate of completion of 3 hours of a recertification course in dry needling.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In order to perform dry needling, a chiropractor with physical therapy privileges shall complete a minimum of 80 hours of total instruction in the following content areas, including:</text> <paragraph num="(1)"> <text>60 hours of:</text> <paragraph num="(a)"> <text>Academic coursework obtained through completion of a college program accredited by the Council of Chiropractic Education, as part of the Doctor of Chiropractic program, including the following minimum requirements:</text> <paragraph num="(i)"> <text>Foundations;</text> </paragraph> <paragraph num="(ii)"> <text>Basic sciences;</text> </paragraph> <paragraph num="(iii)"> <text>Clinical sciences; and</text> </paragraph> <paragraph num="(iv)"> <text>Professional practice; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Coursework required to sit for Part I, Part II, Part III, Physiotherapy, and Part IV of the examination administered by the National Board of Chiropractic Examiners; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Board-approved coursework consisting of 20 hours to be done in a hands-on classroom setting, including but not limited to the following learning topics:</text> <paragraph num="(a)"> <text>Philosophy and historical perspective of dry needling;</text> </paragraph> <paragraph num="(b)"> <text>Indications, contra-indications, and qualifications for treatment;</text> </paragraph> <paragraph num="(c)"> <text>Protocols, doctor and patient safety, usage of dry needling, and dry needling as a diagnostic tool;</text> </paragraph> <paragraph num="(d)"> <text>Case management and jurisprudence; and</text> </paragraph> <paragraph num="(e)"> <text>Direct, hands-on implementation and testing for competency in dry needling of:</text> <paragraph num="(i)"> <text>Cervical, thoracic, lumbar, and pelvic regions;</text> </paragraph> <paragraph num="(ii)"> <text>Anterior and posterior thoracic and ribs;</text> </paragraph> <paragraph num="(iii)"> <text>The upper and lower extremity;</text> </paragraph> <paragraph num="(iv)"> <text>The face and head;</text> </paragraph> <paragraph num="(v)"> <text>Technique; and</text> </paragraph> <paragraph num="(vi)"> <text>Needle size and gauge appropriateness.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration Required."> <paragraph num="A."> <text>The Board shall register a chiropractor with physical therapy privileges as qualified to perform dry needling in the State, provided the chiropractor submits to the Board:</text> <paragraph num="(1)"> <text>Evidence of completion of the education and training requirements outlined in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An application for registration on a form provided by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A chiropractor with physical therapy privileges may not perform dry needling without registering with the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§3-101, 3-205(a), 3-307, 3-403, and 13-101, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective April 4, 2022 (49:7 Md. R. 467)</annotation> </annotations> </chapter> <chapter num="17" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of chiropractic using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in the chapter restricts or limits reimbursement requirements pursuant to the Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Chiropractic Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means a Maryland licensed chiropractor performing telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, Title 3, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license number; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of the recommended treatment plan;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the patient’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person chiropractic practice appointments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>A telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing a treatment plan through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a telehealth practitioner who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006 and 3-205,, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 797)</annotation> </annotations> </chapter> <chapter num="18" heading="Massage Therapy — Code of Ethics" reason="Recodified"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 6, 2014 (40:26 Md. R. 2164); April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.18 to COMAR 10.65.03 under new Subtitle, Board of Massage Therapy Examiners, Code of Ethics, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="19" heading="Massage Therapy — Advertising"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: May 29, 2000 (27:10 Md. R. 966)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 13, 2011 (38:12 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03G amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.19 to COMAR 10.65.04 under new Subtitle, Board of Massage Therapy Examiners, Advertising, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="20" heading="Massage Therapy — Continuing Education Requirements" reason="Recodified"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: June 24, 2002 (29:12 Md. R. 928)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 18, 2003 (30:16 Md. R. 1075); April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.20 to COMAR 10.65.05 under new Subtitle, Board of Massage Therapy Examiners, Continuing Education Requirements, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="21" heading="Massage Therapy — Record Keeping" reason="Recodified"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Subtitle recodified from COMAR 10.43.21 to COMAR 10.65.06, Board of Massage Therapy Examiners, Record Keeping, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> </subtitle> <subtitle num="44" heading="Board of Dental Examiners"> <chapter num="01" heading="Dental Assistants"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Dental assistant” means a person, other than an individual licensed in the state as a dentist or dental hygienist, employed for the purpose of assisting a dentist in the performance of intraoral duties related to dental care.</text> </paragraph> <paragraph num="(3)"> <text>“Direct supervision” means that the supervising dentist is in the dental office, personally diagnoses the condition to be treated, personally authorizes the procedure, and, before dismissal of the patient, personally evaluates the performance of the dental assistant.</text> </paragraph> <paragraph num="(4)"> <text>“General supervision” means the supervision of a dental assistant by a dentist where the dentist may or may not be present when the dental assistant performs the dental assisting procedures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Exceptions."> <paragraph num="A."> <text>Notwithstanding any other provisions of this chapter, a dental assistant may provide the following dental assisting duties under the general supervision of a dentist for a dental sealant program:</text> <paragraph num="(1)"> <text>Instructing on oral hygiene;</text> </paragraph> <paragraph num="(2)"> <text>Cleaning and disinfecting environmental surfaces and equipment;</text> </paragraph> <paragraph num="(3)"> <text>Preparing materials for the application of sealants;</text> </paragraph> <paragraph num="(4)"> <text>Retracting lips, cheek, and tongue;</text> </paragraph> <paragraph num="(5)"> <text>Placing and removing materials for the isolation of the dentition, if the material is not retained by the dentition;</text> </paragraph> <paragraph num="(6)"> <text>Transferring instruments and sealants to a dentist or dental hygienist;</text> </paragraph> <paragraph num="(7)"> <text>Rinsing and aspirating of the oral cavity; and</text> </paragraph> <paragraph num="(8)"> <text>Sterilizing instruments.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Under general supervision of a dentist, a dental assistant may only perform the duties enumerated in §A of this regulation:</text> <paragraph num="(1)"> <text>For a facility that has been granted a waiver of on-site supervision for a dental hygienist under COMAR 10.44.21; and</text> </paragraph> <paragraph num="(2)"> <text>While assisting a dental hygienist who has received a waiver of on-site supervision under COMAR 10.44.21.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dental assistant who provides dental assistant duties under this regulation shall maintain cardiopulmonary resuscitation certification from one of the following programs:</text> <paragraph num="(1)"> <text>The American Heart Association's Basic Life Support for Healthcare Providers;</text> </paragraph> <paragraph num="(2)"> <text>The American Red Cross's Cardiopulmonary Resuscitation for Professional Rescuers; or</text> </paragraph> <paragraph num="(3)"> <text>An equivalent program approved by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A dental assistant who provides dental assistant duties under this regulation shall have at least 400 hours of dental assisting clinical practice in direct patient care.</text> </paragraph> <paragraph num="E."> <text>A dental assistant who provides dental assistant duties under this regulation shall successfully complete a Board-approved course of at least 2 hours in infection control with OSHA protocol if the dental assistant is not:</text> <paragraph num="(1)"> <text>Certified by the Dental Assisting National Board as qualified in general duties and recognized by the Dental Board as qualified in general duties;</text> </paragraph> <paragraph num="(2)"> <text>Certified by the Dental Assisting National Board as qualified in orthodontics and recognized by the Dental Board as qualified in orthodontics; or</text> </paragraph> <paragraph num="(3)"> <text>Certified by the Dental Assisting National Board as a certified dental assistant or certified orthodontic assistant.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A facility that uses a dental assistant to provide dental assistant duties under this regulation shall ensure that there is a written agreement between the supervising dentist and the dental assistant practicing under general supervision that clearly sets forth the terms and conditions under which the dental assistant may practice, including a statement that the dental assistant may provide dental assistant duties without the supervising dentist on the premises.</text> </paragraph> <paragraph num="G."> <text>Each facility that uses the services of a dental assistant to provide dental assistant duties under this regulation shall maintain for 5 years for inspection by the Board:</text> <paragraph num="(1)"> <text>The name of the dentist providing general supervision to the dental assistant;</text> </paragraph> <paragraph num="(2)"> <text>The name and current address of the dental assistant;</text> </paragraph> <paragraph num="(3)"> <text>The name and address of each institution where the dental assistant provided dental assistant duties; and</text> </paragraph> <paragraph num="(4)"> <text>The date the dental assistant provided dental assistant duties.</text> </paragraph> </paragraph> <paragraph num="H."> <text>This regulation does not affect the duties a dental assistant may lawfully perform under the direct supervision of a dentist under this chapter.</text> </paragraph> <paragraph num="I."> <text>A violation of this regulation may result in:</text> <paragraph num="(1)"> <text>Revocation of the facility's right to operate under a waiver of on-site supervision for dental hygienists; or</text> </paragraph> <paragraph num="(2)"> <text>Revocation of the facility's right to utilize the services of a dental assistant under this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Penalties.</text> <paragraph num="(1)"> <text>For violations of this regulation, a dentist or dental assistant is subject to the penalties contained in Regulation .08 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A dental hygienist who uses the services of a dental assistant who is not qualified or for purposes other than what are permitted under this regulation may be found guilty of:</text> <paragraph num="(a)"> <text>Unprofessional conduct under Health Occupations Article, §4-315(b)(3), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Violating any rule or regulation adopted by the Board under Health Occupations Article, §4-315(b)(9), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Intraoral Procedures Permitted To Be Performed by a Dental Assistant."> <text>A dentist may use the services of a dental assistant to perform the following intraoral duties under the direct supervision of a dentist:</text> <paragraph num="A."> <text>Rinsing and aspiration of the oral cavity;</text> </paragraph> <paragraph num="B."> <text>Retraction of the lips, cheek, tongue, and flaps;</text> </paragraph> <paragraph num="C."> <text>Placement and removal of materials for the isolation of the dentition, provided that the material is not retained by the dentition;</text> </paragraph> <paragraph num="D."> <text>Instructing on oral hygiene;</text> </paragraph> <paragraph num="E."> <text>Performing intraoral photography;</text> </paragraph> <paragraph num="F."> <text>Taking impressions for study models or diagnostic casts;</text> </paragraph> <paragraph num="G."> <text>Constructing athletic mouth guards on models;</text> </paragraph> <paragraph num="H."> <text>Applying topical anesthesia;</text> </paragraph> <paragraph num="I."> <text>Curing by the use of halogen light;</text> </paragraph> <paragraph num="J."> <text>Checking for loose bands; and</text> </paragraph> <paragraph num="K."> <text>Any other duty approved by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Dental Assistants Recognized as Qualified in Orthodontics."> <paragraph num="A."> <text>A dentist may use the services of a dental assistant to perform certain duties if the dental assistant:</text> <paragraph num="(1)"> <text>Has successfully completed a Board-approved course of at least 35 hours related to Maryland orthodontic dental assisting; and</text> </paragraph> <paragraph num="(2)"> <text>Is certified by the Dental Assisting National Board in orthodontics or was recognized by the Board of Dental Examiners, on or before June 19, 1974, as a dental assistant qualified in orthodontics.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a dental assistant meets the qualifications of §A of this regulation, a dentist may permit the dental assistant qualified in orthodontics to perform the following intraoral tasks, provided that the tasks are performed only in response to a specific instruction from and under direct supervision of a licensed dentist:</text> <paragraph num="(1)"> <text>Taking impressions for study models or diagnostic casts;</text> </paragraph> <paragraph num="(2)"> <text>Applying topical fluoride;</text> </paragraph> <paragraph num="(3)"> <text>Preparing and fitting orthodontic bands;</text> </paragraph> <paragraph num="(4)"> <text>Etching;</text> </paragraph> <paragraph num="(5)"> <text>Removing excess cement from around orthodontic bands;</text> </paragraph> <paragraph num="(6)"> <text>Placing and removing arch wires;</text> </paragraph> <paragraph num="(7)"> <text>Cementing of orthodontic bands, placement of bonded attachments, or the removal of cemented or bonded orthodontic bands and attachments:</text> </paragraph> <paragraph num="(8)"> <text>Placing elastics and ligatures;</text> </paragraph> <paragraph num="(9)"> <text>Selecting headgear;</text> </paragraph> <paragraph num="(10)"> <text>Applying desensitizing agents;</text> </paragraph> <paragraph num="(11)"> <text>Applying topical anesthesia;</text> </paragraph> <paragraph num="(12)"> <text>Constructing athletic mouth guards on models;</text> </paragraph> <paragraph num="(13)"> <text>Taking alginate impressions for intraoral appliances;</text> </paragraph> <paragraph num="(14)"> <text>Curing by the use of halogen light; and</text> </paragraph> <paragraph num="(15)"> <text>Any other duty approved by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dentist may not use the services of a dental assistant qualified in orthodontics to perform any of the following services on the basis that the dental assistant meets the qualifications of §A of this regulation:</text> <paragraph num="(1)"> <text>Examination, diagnosis, and treatment planning;</text> </paragraph> <paragraph num="(2)"> <text>Surgery on hard or soft tissues;</text> </paragraph> <paragraph num="(3)"> <text>Oral prophylactic procedures, including scaling, root planing, and polishing of teeth with rotary instruments;</text> </paragraph> <paragraph num="(4)"> <text>Condensing, carving, or finishing any restoration;</text> </paragraph> <paragraph num="(5)"> <text>Administering injectable local anesthesia;</text> </paragraph> <paragraph num="(6)"> <text>Applying pit and fissure sealants;</text> </paragraph> <paragraph num="(7)"> <text>Initiation of treatment at any time for the correction of malocclusions and malformations of the teeth or jaws;</text> </paragraph> <paragraph num="(8)"> <text>Adjusting occlusion of natural teeth, restorations, or appliances;</text> </paragraph> <paragraph num="(9)"> <text>Placing an initial surgical dressing;</text> </paragraph> <paragraph num="(10)"> <text>Performing vitality tests;</text> </paragraph> <paragraph num="(11)"> <text>Preparing temporary crowns;</text> </paragraph> <paragraph num="(12)"> <text>Cementing temporary or permanent crowns or restorations;</text> </paragraph> <paragraph num="(13)"> <text>Removing temporary crowns;</text> </paragraph> <paragraph num="(14)"> <text>Placing or removing retraction cord;</text> </paragraph> <paragraph num="(15)"> <text>Placing or removing a rubber dam;</text> </paragraph> <paragraph num="(16)"> <text>Placing or removing a matrix band;</text> </paragraph> <paragraph num="(17)"> <text>Preparing and fitting stainless steel crowns;</text> </paragraph> <paragraph num="(18)"> <text>Drying a root canal;</text> </paragraph> <paragraph num="(19)"> <text>Removing or placing a periodontal dressing; and</text> </paragraph> <paragraph num="(20)"> <text>Adjusting prosthetic appliances.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Dental Assistants Recognized as Qualified in General Duties."> <paragraph num="A."> <text>A dentist may use the services of a dental assistant to perform certain duties if the dental assistant:</text> <paragraph num="(1)"> <text>Has successfully completed a Board-approved course of at least 35 hours related to Maryland general duties dental assisting; and</text> </paragraph> <paragraph num="(2)"> <text>Is certified by the Dental Assisting National Board as qualified in general duties or was recognized by the Board of Dental Examiners, on or before June 19, 1974, as a dental assistant qualified in general duties.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a dental assistant meets the qualifications of §A of this regulation, a dentist may use the services of the dental assistant qualified in general duties to perform the following intraoral tasks, provided that the tasks are performed only in response to a specific instruction from and under the direct supervision of a licensed dentist:</text> <paragraph num="(1)"> <text>Performing vitality tests;</text> </paragraph> <paragraph num="(2)"> <text>Taking impressions for study models or diagnostic casts;</text> </paragraph> <paragraph num="(3)"> <text>Taking alginate impressions for intraoral appliances;</text> </paragraph> <paragraph num="(4)"> <text>Applying topical fluoride;</text> </paragraph> <paragraph num="(5)"> <text>Applying desensitizing agents;</text> </paragraph> <paragraph num="(6)"> <text>Applying topical anesthesia;</text> </paragraph> <paragraph num="(7)"> <text>Placing or removing a rubber dam;</text> </paragraph> <paragraph num="(8)"> <text>Etching;</text> </paragraph> <paragraph num="(9)"> <text>Curing by the use of a halogen light;</text> </paragraph> <paragraph num="(10)"> <text>Fabricating indirect restorations in a dental office;</text> </paragraph> <paragraph num="(11)"> <text>Placing or removing a matrix band;</text> </paragraph> <paragraph num="(12)"> <text>Drying a root canal;</text> </paragraph> <paragraph num="(13)"> <text>Preparing and fitting stainless steel crowns;</text> </paragraph> <paragraph num="(14)"> <text>Placing or removing retraction cord;</text> </paragraph> <paragraph num="(15)"> <text>Preparing temporary crowns;</text> </paragraph> <paragraph num="(16)"> <text>Cementing temporary crowns or restorations;</text> </paragraph> <paragraph num="(17)"> <text>Removing temporary crowns;</text> </paragraph> <paragraph num="(18)"> <text>Removing excess cement;</text> </paragraph> <paragraph num="(19)"> <text>Removing or placing a periodontal dressing (except placing the original periodontal dressing);</text> </paragraph> <paragraph num="(20)"> <text>Removing sutures;</text> </paragraph> <paragraph num="(21)"> <text>Constructing athletic mouth guards on models; and</text> </paragraph> <paragraph num="(22)"> <text>Any other duty approved by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dentist may not use the services of a dental assistant qualified in general duties to perform any of the following services on the basis that the dental assistant meets the qualifications of §A of this regulation:</text> <paragraph num="(1)"> <text>Examination, diagnosis, and treatment planning;</text> </paragraph> <paragraph num="(2)"> <text>Surgery on hard or soft tissues;</text> </paragraph> <paragraph num="(3)"> <text>Oral prophylactic procedures, including scaling, root planing, and polishing teeth;</text> </paragraph> <paragraph num="(4)"> <text>Condensing, carving, or finishing any restoration;</text> </paragraph> <paragraph num="(5)"> <text>Administering injectable local anesthesia;</text> </paragraph> <paragraph num="(6)"> <text>Applying pit and fissure sealants;</text> </paragraph> <paragraph num="(7)"> <text>Initiation of treatment at any time for the correction of malocclusions and malformations of the teeth or jaws;</text> </paragraph> <paragraph num="(8)"> <text>Cementing of orthodontic bands, placement of bonded attachments or the removal of cemented or bonded orthodontic bands and attachments;</text> </paragraph> <paragraph num="(9)"> <text>Cementing permanent crowns or restorations;</text> </paragraph> <paragraph num="(10)"> <text>Adjusting occlusion of natural teeth, restorations, or appliances;</text> </paragraph> <paragraph num="(11)"> <text>Registration of jaw relations;</text> </paragraph> <paragraph num="(12)"> <text>Placing an initial surgical dressing;</text> </paragraph> <paragraph num="(13)"> <text>Preparing or fitting orthodontic bands;</text> </paragraph> <paragraph num="(14)"> <text>Placing or removing an arch wire;</text> </paragraph> <paragraph num="(15)"> <text>Selecting headgear;</text> </paragraph> <paragraph num="(16)"> <text>Placing elastics or ligatures; and</text> </paragraph> <paragraph num="(17)"> <text>Adjusting prosthetic appliances.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Radiographs."> <text>A dentist may not permit a dental assistant to place and expose radiographs unless the dental assistant is a dental assistant certified to practice dental radiation technology.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Posting."> <text>The dentist in charge of a dental office shall post a copy of these regulations and the list of Board-approved dental assistant duties in a conspicuous place in the office for the information of office personnel.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Penalties for Violations of These Regulations."> <paragraph num="A."> <text>A dentist who uses the services of a dental assistant who is not qualified or for purposes other than what is permitted may be found guilty of unprofessional conduct under Health Occupations Article, §4-315(a)(16), Annotated Code of Maryland, or violating any rule or regulation adopted by the Board under Health Occupations Article, §4-315(a)(18), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The performance of intraoral duties not authorized by these regulations by a dental assistant may constitute the illegal practice of dentistry, a misdemeanor which on conviction is subject to:</text> <paragraph num="(1)"> <text>For a first offense, a fine not exceeding $2,000 or imprisonment in jail not exceeding 6 months; or</text> </paragraph> <paragraph num="(2)"> <text>For a subsequent offense, a fine not exceeding $6,000 or imprisonment in the State penitentiary not exceeding 1 year.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 1974</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 20, 1981 (8:14 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 31, 1984 (11:26 Md. R. 2278)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 19, 1990 (17:3 Md. R. 300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 23, 2006 (33:21 Md. R. 1677)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted effective October 23, 2006 (33:21 Md. R. 1677)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective January 7, 2016 (42:26 Md. R. 1595)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 7, 2002 (28:26 Md. R. 2274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 7, 2002 (28:26 Md. R. 2274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 6, 2016 (43:11 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 7, 2002 (28:26 Md. R. 2274)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 6, 2016 (43:11 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensure of Graduates of Foreign Dental Schools"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means any person applying for a license to practice dentistry pursuant to the provisions of these regulations and of Health Occupations Article, §§4-303 and 4-303.1, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Graduate of a foreign dental school” means any person who has graduated from a dental school located in any country outside the United States, its territories, districts, or possessions and the Dominion of Canada, and recognized by the country in which it is located.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Limited License to Practice Dentistry; Exclusion."> <paragraph num="A."> <text>This regulation does not apply to a pediatric dental fellow or an individual who has successfully completed a pediatric dental fellowship. The requirements for these individuals are contained in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="B."> <text>In addition to meeting the requirements set forth in Health Occupations Article, §4-302, Annotated Code of Maryland, with respect to moral character, and in addition to passing any required examination, to qualify for a limited license to practice dentistry, a graduate of a foreign dental school shall be 21 years old or older and shall submit the following credentials to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form the Board prescribes and furnishes to the applicant, accompanied by a 3 inch by 3 inch notarized photograph of the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Evidence satisfactory to the Board that the applicant has completed at least 24 months of formal general clinical training in a United States or Canadian accredited institution;</text> </paragraph> <paragraph num="(3)"> <text>A copy of the degree or diploma issued to the applicant by the foreign dental school conferring it, properly authenticated by an official of that foreign dental school authorized to make the authentication;</text> </paragraph> <paragraph num="(4)"> <text>A copy of the subjects taken and the credits earned by the applicant at the foreign dental school, duly authenticated by an official authorized to make the authentication;</text> </paragraph> <paragraph num="(5)"> <text>A license to practice dentistry issued by the foreign country, or the proper subdivision of the country, in which the applicant has graduated, duly authenticated by the issuing authority;</text> </paragraph> <paragraph num="(6)"> <text>A translation into English of a degree, diploma, or license required to be furnished to the Board, certified by an individual acceptable to the Board, if issued in a language other than English;</text> </paragraph> <paragraph num="(7)"> <text>Two letters of recommendation written by persons acceptable to the Board, which shall certify to the Board the good moral character of the applicant and the applicant's age, qualifications, background, and experience, if any; and</text> </paragraph> <paragraph num="(8)"> <text>A letter indicating that the applicant possesses sufficient comprehension and communication skills in written and spoken English to enable the applicant to adequately treat dental patients.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The letter required in §B(8) of this regulation shall be received from:</text> <paragraph num="(1)"> <text>The administrator of the hospital at which the license is limited;</text> </paragraph> <paragraph num="(2)"> <text>The administrator of the sanitarium at which the license is limited;</text> </paragraph> <paragraph num="(3)"> <text>The dean of the dental school at which the license is limited; or</text> </paragraph> <paragraph num="(4)"> <text>The administrator of the public health program at which the license is limited.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of Health Occupations Article, §4-304, Annotated Code of Maryland, a graduate of a foreign dental school applying for a limited license to practice dentistry under these regulations shall submit to the Board with the application the credentials processing fee as specified in COMAR 10.44.20. This fee is not refundable in whole or in part.</text> </paragraph> <paragraph num="E."> <text>A limited license to practice dentistry in this State is valid for 1 year from the date of issuance and is not renewable.</text> </paragraph> <paragraph num="F."> <text>An individual who has been in possession of a limited license may reapply for a limited license by submitting a new application to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Limited License to Practice Pediatric Dentistry for Certain Individuals."> <paragraph num="A."> <text>In addition to meeting the requirements set forth in Health Occupations Article, §4-303.1, Annotated Code of Maryland, with respect to moral character, and in addition to passing any required examination, to qualify for a limited license to practice pediatric dentistry in a public health dental clinic, federally qualified health center, or Maryland qualified health center under Health Occupations Article, §4-303.1, Annotated Code of Maryland, a graduate of a foreign dental school shall submit the following credentials to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>A copy of the degree or diploma issued to the applicant by the foreign dental school conferring it, properly authenticated by an official of that foreign dental school authorized to make the authentication;</text> </paragraph> <paragraph num="(4)"> <text>A copy of the subjects taken and the credits earned by the applicant at the foreign dental school, duly authenticated by an official authorized to make the authentication;</text> </paragraph> <paragraph num="(5)"> <text>A translation into English of a degree, diploma, or subjects taken which are required to be submitted to the Board, certified by an individual acceptable to the Board, if issued in a language other than English;</text> </paragraph> <paragraph num="(6)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant holds an active dental license or ever held an active dental license indicating that the license is or was in good standing and whether the applicant:</text> <paragraph num="(a)"> <text>Is being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Has charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has been disciplined; or</text> </paragraph> <paragraph num="(d)"> <text>Has been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A copy of the applicant's National Practitioners Data Bank file;</text> </paragraph> <paragraph num="(8)"> <text>Proof satisfactory to the Board that the applicant has passed parts one and two of the National Board Examinations conducted by the Council of National Boards of the American Dental Association;</text> </paragraph> <paragraph num="(9)"> <text>Proof satisfactory to the Board that the applicant has successfully completed at least a 2-year pediatric dentistry residency program at a dental school or a hospital authorized by any state and which is recognized by the Board;</text> </paragraph> <paragraph num="(10)"> <text>Proof satisfactory to the Board that the applicant is either a pediatric dental fellow, or has successfully completed a pediatric dental fellowship at the University of Maryland Dental School;</text> </paragraph> <paragraph num="(11)"> <text>Proof satisfactory to the Board that the applicant is contractually obligated to provide pediatric dental services for at least 2 years in a:</text> <paragraph num="(a)"> <text>Public health dental clinic operated by the State or a county or municipality of the State;</text> </paragraph> <paragraph num="(b)"> <text>Federally qualified health center; or</text> </paragraph> <paragraph num="(c)"> <text>Maryland qualified health center;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>A letter from the health officer of the public health program for which the applicant has contractually agreed to provide at least 2 years of pediatric dental services:</text> <paragraph num="(a)"> <text>Requesting that the Board waive the education requirements of Health Occupations Article, §4-302, Annotated Code of Maryland, for the applicant;</text> </paragraph> <paragraph num="(b)"> <text>Stating that circumstances exist to justify granting the waiver; and</text> </paragraph> <paragraph num="(c)"> <text>Requesting that a limited license be issued to the applicant;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>A letter from the Dean of the University of Maryland Dental School:</text> <paragraph num="(a)"> <text>Requesting that the Board waive the education requirements of Health Occupations Article, §4-302, Annotated Code of Maryland for the applicant; and</text> </paragraph> <paragraph num="(b)"> <text>Stating that circumstances exist to justify granting the waiver;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Two letters of recommendation written by persons acceptable to the Board, which certify to the Board the applicant's:</text> <paragraph num="(a)"> <text>Good moral character;</text> </paragraph> <paragraph num="(b)"> <text>Age;</text> </paragraph> <paragraph num="(c)"> <text>Qualifications;</text> </paragraph> <paragraph num="(d)"> <text>Background; and</text> </paragraph> <paragraph num="(e)"> <text>Experience, if any;</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>A letter from the dean of the dental school at which the license is limited indicating that the applicant possesses sufficient comprehension and communication skills in written and spoken English to enable the applicant to adequately treat dental patients;</text> </paragraph> <paragraph num="(16)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(17)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A limited license to practice dentistry in this State is valid for 1 year from the date of issuance and is not renewable.</text> </paragraph> <paragraph num="C."> <text>An individual who has been in possession of a limited license may reapply for a limited license by submitting a new application to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Fees."> <paragraph num="A."> <text>Fees as specified in COMAR 10.44.20 shall accompany the application.</text> </paragraph> <paragraph num="B."> <text>The credentials processing fee for limited licenses is not refundable in whole or in part.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements — General License for a Limited Licensee Granted a Waiver."> <paragraph num="A."> <text>A limited licensee granted a waiver under Health Occupations Article, §4-303.1, Annotated Code of Maryland, may be granted a general license if the limited licensee fulfills the requirements of Health Occupations Article, §4-303.1, Annotated Code of Maryland, and submits the following credentials to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>A copy of the degree or diploma issued to the applicant by the foreign dental school conferring it, properly authenticated by an official of that foreign dental school authorized to make the authentication;</text> </paragraph> <paragraph num="(4)"> <text>A copy of the subjects taken and the credits earned by the applicant at the foreign dental school, properly authenticated by an official authorized to make the authentication;</text> </paragraph> <paragraph num="(5)"> <text>If issued in a language other than English, a translation into English of a degree, diploma, or subjects taken which are required to be submitted to the Board, certified by an individual acceptable to the Board;</text> </paragraph> <paragraph num="(6)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant holds an active dental license or ever held an active dental license, indicating that the license is or was in good standing and whether the applicant:</text> <paragraph num="(a)"> <text>Is being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Has charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has been disciplined;</text> </paragraph> <paragraph num="(d)"> <text>Has been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A copy of the applicant's National Practitioners Data Bank file;</text> </paragraph> <paragraph num="(8)"> <text>Proof satisfactory to the Board that the applicant has passed the written and clinical examinations of the North East Regional Board;</text> </paragraph> <paragraph num="(9)"> <text>Proof satisfactory to the Board that the applicant has passed parts one and two of the National Board Examinations conducted by the Council of National Boards of the American Dental Association;</text> </paragraph> <paragraph num="(10)"> <text>Proof satisfactory to the Board that the applicant has successfully completed at least a 2-year pediatric dentistry residency program at a dental school or a hospital authorized by any state and which is recognized by the Board;</text> </paragraph> <paragraph num="(11)"> <text>Proof satisfactory to the Board that the applicant has successfully completed a pediatric dental fellowship at the University of Maryland Dental School;</text> </paragraph> <paragraph num="(12)"> <text>Proof satisfactory to the Board that the applicant has successfully completed the applicant's contractual obligation to provide pediatric dental services for at least 2 years in a:</text> <paragraph num="(a)"> <text>Public health dental clinic operated by the State or a county or municipality of the State;</text> </paragraph> <paragraph num="(b)"> <text>Federally qualified health center; or</text> </paragraph> <paragraph num="(c)"> <text>Maryland qualified health center;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Two letters of recommendation written by persons acceptable to the Board, which certify to the Board the applicant's:</text> <paragraph num="(a)"> <text>Good moral character;</text> </paragraph> <paragraph num="(b)"> <text>Age;</text> </paragraph> <paragraph num="(c)"> <text>Qualifications;</text> </paragraph> <paragraph num="(d)"> <text>Background; and</text> </paragraph> <paragraph num="(e)"> <text>Experience, if any;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Proof of passing the Maryland Dental Jurisprudence Examination on the Maryland State Dental Law;</text> </paragraph> <paragraph num="(15)"> <text>Documentation of changes of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(16)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall be 18 years old or older.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Requirements for Teacher's License to Practice Dentistry."> <paragraph num="A."> <text>In addition to meeting the requirements set forth in Health Occupations Article, §4-302, Annotated Code of Maryland, with respect to moral character, to qualify for a teacher's license to practice dentistry, a graduate of a foreign dental school shall:</text> <paragraph num="(1)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Hold a degree of Doctor of Dental Surgery, Doctor of Dental Medicine, or an equivalent degree from a school, college, or faculty of dentistry; and</text> </paragraph> <paragraph num="(3)"> <text>Submit the following credentials to the Board:</text> <paragraph num="(a)"> <text>A completed application, on a form the Board prescribes and furnishes to the applicant, accompanied by a 3 inch by 3 inch notarized photograph of the applicant;</text> </paragraph> <paragraph num="(b)"> <text>A copy of the degree or diploma issued to the applicant by the foreign dental school conferring it, properly authenticated by an official of that foreign dental school authorized to make the authentication;</text> </paragraph> <paragraph num="(c)"> <text>A copy of the subjects taken and the credits earned by the applicant at the foreign dental school, duly authenticated by an official of that foreign dental school authorized to make the authentication;</text> </paragraph> <paragraph num="(d)"> <text>A translation into English of a degree or diploma required to be furnished to the Board, certified by an individual acceptable to the Board, if issued in a language other than English;</text> </paragraph> <paragraph num="(e)"> <text>Two letters of recommendation, written by persons acceptable to the Board, which shall certify to the Board the good moral character of the applicant and the applicant's age, qualifications, background, and experience, if any;</text> </paragraph> <paragraph num="(f)"> <text>A letter from the dean of the dental school at which the license is limited indicating that the applicant possesses sufficient comprehension and communication skills in written and spoken English to enable the applicant to adequately treat dental patients;</text> </paragraph> <paragraph num="(g)"> <text>Proof satisfactory to the Board that the applicant has at least 5 years of clinical dental experience; and</text> </paragraph> <paragraph num="(h)"> <text>Proof satisfactory to the Board that the applicant is professionally competent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the applicant has been tested, licensed, or qualified in some other state of the United States, or its districts, territories, or possessions, the Board may accept the credentials submitted to the other state, district, territory, or possession, provided that the credentials meet the minimum standards of the Board as set forth in these regulations.</text> </paragraph> <paragraph num="C."> <text>In addition to the requirements of Health Occupations Article, §4-304, Annotated Code of Maryland, a graduate of a foreign dental school applying for a teacher's license to practice dentistry under this chapter shall submit to the Board with the application the credentials processing fee as specified in COMAR 10.44.20. This fee is not refundable in whole or in part.</text> </paragraph> <paragraph num="D."> <text>The requirements of §A(3)(e) of this regulation shall be waived if the applicant:</text> <paragraph num="(1)"> <text>Is approved by the Dean of the University of Maryland Dental School;</text> </paragraph> <paragraph num="(2)"> <text>Fulfills §A(1), (2), and (3)(a) — (d) and (g) — (h) of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Is appointed to a full-time faculty position at the University of Maryland Dental School.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A teacher's license to practice dentistry in the State is immediately void upon leaving the faculty position at the University of Maryland Dental School.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-303 and 4-303.1, Annotated Code of Maryland; Ch. 131, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 7, 1973</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 17, 1978 (5:23 Md. R. 1740); October 3, 1980 (7:20 Md. R. 1880)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05 amended effective July 29, 1985 (12:15 Md. R. 1520)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 5, 1999 (26:7 Md. R. 544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 19, 2001 (28:3 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 19, 2001 (28:3 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 11, 2003 (30:24 Md. R. 1743)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> </annotations> </chapter> <chapter num="03" heading="The Conduct of Experimental Programs in Dental Schools or Colleges in the State, Which Use Dental Assistants, Dental Hygienists, or Both, in the Training of Students Enrolled in the Dental School or College"> <regulation prefix="Regulation" num=".01" heading="General Requirements."> <paragraph num="A."> <text>Any experimental program shall be under the direct supervision of a full time faculty member of the dental school or college.</text> </paragraph> <paragraph num="B."> <text>All dental assistants utilized by or employed in connection with any program shall be “qualified dental assistants” as that term is defined in the regulations of the Board.</text> </paragraph> <paragraph num="C."> <text>All dental hygienists utilized by or employed in connection with any program shall be duly licensed to practice dental hygiene in the State of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Specific Program Requirements."> <paragraph num="A."> <text>If the conduct of an experimental program requires the delegation to a dental assistant or the hygienist would not otherwise be permitted to perform by law or regulation of the Board, the faculty supervisor of the experimental program shall notify in writing the assistant or hygienists, as well as students participating in the program, of the fact that this delegation of duty is for the purpose of the experimental program only and that the performance of the delegated duties by an assistant or hygienist, outside the experimental program, may be in violation of law or the regulations of the Board.</text> </paragraph> <paragraph num="B."> <text>On and after June 1, 1973, all experimental programs proposed to be conducted in dental school or college, and not theretofore implemented which may involve dental procedures not otherwise approved by law or regulation of the Board, shall be submitted to the Board of Dental Examiners and the Maryland State Dental Association for review and comment at least 180 days in advance of the beginning of the experimental program.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-308 and 4-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 1974</annotation> </annotations> </chapter> <chapter num="04" heading="Practice of Dental Hygiene"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the practice of dental hygiene by all licensed dental hygienists in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administer medication” means the direct introduction of a single dosage of a medication by a dental hygienist while the patient is physically on the premises where the treatment is rendered.</text> </paragraph> <paragraph num="(2)"> <text>“Administer nitrous oxide” means the initiation, adjustment, monitoring, and termination of the flow of nitrous oxide.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(4)"> <text>“CDCA” means the Commission on Dental Competency Assessments or its successor organization.</text> </paragraph> <paragraph num="(5)"> <text>“Dental hygienist” means a registered dental hygienist who holds an active license to practice dental hygiene in Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Dentist" means a dentist who holds an active license to practice dentistry in Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Dispense medication” means a dental hygienist disbursing a single dosage or multiple dosages of a medication to a patient or an agent of the patient for introduction at a time subsequent to the rendered treatment.</text> </paragraph> <paragraph num="(8)"> <text>“Monitor” means the observation of the patient:</text> <paragraph num="(a)"> <text>During the flow of nitrous oxide;</text> </paragraph> <paragraph num="(b)"> <text>During the reduction of the flow of nitrous oxide;</text> </paragraph> <paragraph num="(c)"> <text>During the shutting off of the equipment controlling the flow of nitrous oxide; and</text> </paragraph> <paragraph num="(d)"> <text>At all times in between the start of the flow of nitrous oxide until after nitrous oxide has been terminated and the patient has fully awoken and is coherent.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Nitrous oxide” means a chemical compound with the formula N2O.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Intraoral Functions."> <paragraph num="A."> <text>The following intraoral functions may be performed in the practice of dental hygiene:</text> <paragraph num="(1)"> <text>Preliminary dental examination;</text> </paragraph> <paragraph num="(2)"> <text>Dental prophylaxis, which includes:</text> <paragraph num="(a)"> <text>Scaling and root planing; or</text> </paragraph> <paragraph num="(b)"> <text>Polishing a tooth or a restoration;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Placing and removing perio dressings, including an initial dressing;</text> </paragraph> <paragraph num="(4)"> <text>Placing sealants;</text> </paragraph> <paragraph num="(5)"> <text>Taking impressions for study models, custom fluoride trays, or athletic mouth guards;</text> </paragraph> <paragraph num="(6)"> <text>Exposing a dental x-ray;</text> </paragraph> <paragraph num="(7)"> <text>Performing a brush biopsy;</text> </paragraph> <paragraph num="(8)"> <text>Placing subgingival medicaments;</text> </paragraph> <paragraph num="(9)"> <text>Cementing temporary crowns or restorations; and</text> </paragraph> <paragraph num="(10)"> <text>Performing any duty that a dental assistant, or a dental assistant who is listed on the roster of dental assistants recognized as qualified in orthodontics or general duties, may perform.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist may administer local anesthesia by infiltration and local anesthesia by inferior alveolar nerve block only after Board recognition as provided in this chapter.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist may perform manual curettage in conjunction with scaling and root planning only after meeting the requirements of Regulation .12 of this chapter.</text> </paragraph> <paragraph num="D."> <text>A dental hygienist may administer nitrous oxide only after Board recognition as provided in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Exceptions."> <text>The following intraoral functions may not be performed in the practice of dental hygiene:</text> <paragraph num="A."> <text>Diagnosis;</text> </paragraph> <paragraph num="B."> <text>Extraction;</text> </paragraph> <paragraph num="C."> <text>Cavity repair;</text> </paragraph> <paragraph num="D."> <text>Tooth placement correction;</text> </paragraph> <paragraph num="E."> <text>Surgical procedures;</text> </paragraph> <paragraph num="F."> <text>Anesthesia procedures other than:</text> <paragraph num="(1)"> <text>Administering topical anesthesia; or</text> </paragraph> <paragraph num="(2)"> <text>Administering local anesthesia by infiltration or local anesthesia by inferior alveolar nerve block in accordance with:</text> <paragraph num="(a)"> <text>Health Occupations Article, §§4-206.1 and 4.206.3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The requirements of Regulation .06 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Administering nitrous oxide in accordance with:</text> <paragraph num="(a)"> <text>Health Occupations Article, §4-206.2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The requirements of Regulation .17 of this chapter;</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Prescribing or administering medication other than:</text> <paragraph num="(1)"> <text>Prescribing and administering medication in accordance with Health Occupations Article, §§4-205 and 4-206.4, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The requirements of Regulation .27 of this chapter;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Condensing, carving, or finishing any restoration; and</text> </paragraph> <paragraph num="I."> <text>Cementing permanent crowns or restorations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Additional Functions for Dental Hygienists Who Obtain Board Recognition."> <text>In addition to those functions described in Regulation .03A of this chapter, a dental hygienist who is recognized by the Board as qualified may:</text> <paragraph num="A."> <text>Administer local anesthesia by infiltration;</text> </paragraph> <paragraph num="B."> <text>Administer local anesthesia by inferior alveolar nerve block;</text> </paragraph> <paragraph num="C."> <text>Administer nitrous oxide; and</text> </paragraph> <paragraph num="D."> <text>Prescribe and administer medication.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Local Anesthesia."> <paragraph num="A."> <text>A dental hygienist who is recognized by the Board to administer local anesthesia may do so provided that the administration of local anesthesia is:</text> <paragraph num="(1)"> <text>By infiltration or by inferior alveolar nerve block to facilitate the practice of dental hygiene by a dental hygienist or the practice of dentistry by a dentist;</text> </paragraph> <paragraph num="(2)"> <text>Not performed as a medical specialty; and</text> </paragraph> <paragraph num="(3)"> <text>Under the supervision of a dentist who:</text> <paragraph num="(a)"> <text>Is physically on the premises; and</text> </paragraph> <paragraph num="(b)"> <text>Prescribes the administration of local anesthesia by the dental hygienist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist may administer local anesthesia only as provided in this regulation.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist may not administer local anesthesia unless recognized by the Board as being qualified to do so as provided in this chapter.</text> </paragraph> <paragraph num="D."> <text>Classification of Board Recognition. The Board shall recognize the classification of recognized to administer local anesthesia.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Manual Curettage."> <paragraph num="A."> <text>A dental hygienist who successfully completes a Board-approved course in manual curettage in conjunction with scaling and root planing as outlined in Regulation .11 of this chapter may perform manual curettage in conjunction with scaling and root planing without applying for or receiving recognition from the Board.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist who successfully completes the Board-approved course in manual curettage in conjunction with scaling and root planing as outlined in Regulation .12 of this chapter shall:</text> <paragraph num="(1)"> <text>Maintain proof of successful completion of the course; and</text> </paragraph> <paragraph num="(2)"> <text>Provide documentation of successful completion of the course to the Board upon the Board's request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Qualifications for Board Recognition to Administer Local Anesthesia."> <paragraph num="A."> <text>A dental hygienist who wishes to receive recognition by the Board as being qualified to administer local anesthesia by infiltration and local anesthesia by inferior alveolar nerve block shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dental hygiene in this State; and</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a Board-approved course of instruction as outlined in Regulation .09 of this chapter that documents training of at least 28 hours consisting of at least:</text> <paragraph num="(a)"> <text>20 hours of didactic training in administering local anesthesia; and</text> </paragraph> <paragraph num="(b)"> <text>8 hours of clinical training in administering local anesthesia.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist shall pass a written and clinical examination administered by the Board-approved course with an overall passing grade of at least 75 percent in both the written examination portion and the clinical examination portion.</text> </paragraph> <paragraph num="C."> <text>The Board-approved course of instruction in administering local anesthesia may be obtained by:</text> <paragraph num="(1)"> <text>A dental hygienist while an undergraduate student in a Board-approved school for dental hygiene that is accredited by the American Dental Association Committee on Dental Accreditation or its successor organization; or</text> </paragraph> <paragraph num="(2)"> <text>A dental hygienist who completes the course offered by an accredited dental hygiene program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of this regulation, a dental hygienist who wishes to receive recognition by the Board as being qualified to administer local anesthesia shall pass the CDCA Local Anesthesia Examination for Dental Hygienists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Board-Approved Course of Instruction for Local Anesthesia."> <text>The 28-hour Board-approved local anesthesia course of instruction outlined in Regulation .08A and B of this chapter shall include but not be limited to the following:</text> <paragraph num="A."> <text>20 hours of didactic training, including at least the following:</text> <paragraph num="(1)"> <text>The psychology of pain management;</text> </paragraph> <paragraph num="(2)"> <text>A review of anatomy, physiology, and pharmacology of anesthetic agents;</text> </paragraph> <paragraph num="(3)"> <text>Emergency precautions and management;</text> </paragraph> <paragraph num="(4)"> <text>Patient management; and</text> </paragraph> <paragraph num="(5)"> <text>Instruction on the safe and effective administration of local anesthesia; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>8 hours of clinical training, including the direct observation of the performance of procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Required Local Anesthesia Refresher Course."> <paragraph num="A."> <text>Before administering local anesthesia by inferior alveolar nerve block, a dental hygienist who successfully completed the education requirements and examination for the 28-hour local anesthesia Board-approved course as outlined in Regulation .08 of this chapter before October 1, 2011 shall:</text> <paragraph num="(1)"> <text>Successfully complete a Board-approved refresher course of at least 2 hours on local anesthesia by inferior alveolar nerve block offered by an accredited dental hygiene program;</text> </paragraph> <paragraph num="(2)"> <text>Pass a clinical examination administered by the Board-approved course with an overall passing grade of at least 75 percent; and</text> </paragraph> <paragraph num="(3)"> <text>Submit a letter from an accredited dental hygiene program indicating that the applicant has:</text> <paragraph num="(a)"> <text>Successfully completed the Board-approved course; and</text> </paragraph> <paragraph num="(b)"> <text>Received an overall passing grade of at least 75 percent in the course’s clinical examination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The letter from the accredited dental hygiene program referred to in §A of this regulation shall:</text> <paragraph num="(1)"> <text>Be on the letterhead of the accredited dental hygiene program;</text> </paragraph> <paragraph num="(2)"> <text>Contain a raised embossed school seal; and</text> </paragraph> <paragraph num="(3)"> <text>Contain the original signature of either:</text> <paragraph num="(a)"> <text>The Dean of the accredited dental hygiene program; or</text> </paragraph> <paragraph num="(b)"> <text>The head of the dental hygiene department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A dental hygienist who is subject to this regulation shall receive written permission from the Board before administering local anesthesia by inferior alveolar nerve block.</text> </paragraph> <paragraph num="D."> <text>A dental hygienist who is subject to §A of this regulation and who has not received written permission from the Board to administer local anesthesia by inferior alveolar nerve block as described in §C of this regulation may administer local anesthesia by infiltration only.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Out-of-State Certification to Administer Local Anesthesia or Manual Curettage."> <paragraph num="A."> <text>Local Anesthesia. A dental hygienist holding an active certification to administer local anesthesia in another state or who is otherwise recognized to administer local anesthesia in another state may be granted recognition to administer local anesthesia in Maryland without taking and passing the Board-approved course outlined in Regulation .08A and B of this chapter if the dental hygienist:</text> <paragraph num="(1)"> <text>Has passed the CDCA Local Anesthesia Examination for Dental Hygienists; and</text> </paragraph> <paragraph num="(2)"> <text>Applies for and receives recognition by the Board as qualified to administer local anesthesia.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Manual Curettage in Conjunction with Scaling and Root Planing. A dental hygienist holding an active certification to perform manual curettage in conjunction with scaling and root planing in another state, or who is otherwise recognized to perform manual curettage in conjunction with scaling and root planing in another state, may, while so certified or recognized in another state, perform manual curettage in conjunction with scaling and root planing without taking and passing the Board-approved course in manual curettage in conjunction with scaling and root planing outlined in Regulation .12 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Board-Approved Course in Manual Curettage in Conjunction with Scaling and Root Planing."> <paragraph num="A."> <text>A dental hygienist who wishes to perform manual curettage in conjunction with scaling and root planing shall successfully complete a 2-hour Board-approved course of instruction in manual curettage in conjunction with scaling and root planing.</text> </paragraph> <paragraph num="B."> <text>The 2-hour Board-approved course of instruction in manual curettage in conjunction with scaling and root planing shall contain a total of 2 hours of didactic instruction.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist who takes the Board-approved course of instruction in manual curettage in conjunction with scaling and root planing outlined in §A of this regulation shall pass a written examination administered by the Board-approved course with a grade of at least 75 percent.</text> </paragraph> <paragraph num="D."> <text>The Board-approved course of instruction in manual curettage in conjunction with scaling and root planing may be obtained by a dental hygienist while an undergraduate student in a Board-approved school for dental hygiene that is accredited by the American Association Committee on Dental Accreditation or its successor organization.</text> </paragraph> <paragraph num="E."> <text>The 2-hour Board-approved course of instruction in manual curettage in conjunction with scaling and root planing:</text> <paragraph num="(1)"> <text>May but need not be taken from an accredited dental hygiene program; and</text> </paragraph> <paragraph num="(2)"> <text>May be taken online.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Continuing Education and Renewal for Local Anesthesia and Manual Curettage."> <paragraph num="A."> <text>A dental hygienist is not required to renew the Board recognition to:</text> <paragraph num="(1)"> <text>Administer local anesthesia; or</text> </paragraph> <paragraph num="(2)"> <text>Perform manual curettage in conjunction with scaling and root planing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist who has successfully completed the following since graduating from an approved school of dental hygiene may receive continuing education credit toward renewal of their dental hygiene license:</text> <paragraph num="(1)"> <text>The 28-hour Board-approved course of instruction for local anesthesia;</text> </paragraph> <paragraph num="(2)"> <text>The 2-hour Board-approved course of instruction in manual curettage in conjunction with scaling and root planing; and</text> </paragraph> <paragraph num="(3)"> <text>The CDCA Local Anesthesia Examination for Dental Hygienists.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Requirements for Instructors for Local Anesthesia Course."> <text>If the Board-approved course of instruction in local anesthesia is taught by a dental hygienist, a dentist shall:</text> <paragraph num="A."> <text>Be present in the classroom during clinical instruction, which includes but is not limited to the administration of local anesthesia; and</text> </paragraph> <paragraph num="B."> <text>Be affiliated with the same dental hygiene program as the dental hygienist teaching the course.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Application for Board Recognition to Administer Local Anesthesia."> <paragraph num="A."> <text>A dental hygienist shall submit a completed Board-approved application with the Board to be recognized as qualified to administer local anesthesia.</text> </paragraph> <paragraph num="B."> <text>Recognized as Qualified to Administer Local Anesthesia.</text> <paragraph num="(1)"> <text>Not Certified or Otherwise Recognized in Another State. A dental hygienist who applies to be recognized as qualified to administer local anesthesia and who is not certified or otherwise recognized to administer local anesthesia in another state shall submit to the Board:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Proof of completion of a 28-hour Board-approved course of instruction in the administration of local anesthesia in the form of a letter from an accredited dental hygiene program indicating that the applicant has:</text> <paragraph num="(i)"> <text>Successfully completed the course; and</text> </paragraph> <paragraph num="(ii)"> <text>Received an overall passing grade of at least 75 percent in both the course's written examination and the course's clinical examination;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A certified examination score from the CDCA indicating that the applicant has passed the CDCA Local Anesthesia Examination for Dental Hygienists;</text> </paragraph> <paragraph num="(d)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(e)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Recognized as Qualified to Administer Local Anesthesia by Virtue of Being Recognized in Another State. A dental hygienist who applies to be recognized as qualified to administer local anesthesia by virtue of being certified or otherwise recognized to administer local anesthesia in another state shall submit the following to the Board:</text> <paragraph num="(a)"> <text>A Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>A certified copy of the dental hygienist's most recent license or certification from the state of licensure or certification, indicating that the dental hygienist holds a current license or certification to administer local anesthesia;</text> </paragraph> <paragraph num="(c)"> <text>A certified examination score from the CDCA indicating that the applicant has passed the CDCA Local Anesthesia Examination for Dental Hygienists;</text> </paragraph> <paragraph num="(d)"> <text>An affidavit indicating that the hygienist has successfully administered local anesthesia at least 25 times in the 2-year period immediately preceding the date of application;</text> </paragraph> <paragraph num="(e)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(f)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The letter from the accredited dental hygiene program referenced in §B(1)(b) of this regulation shall:</text> <paragraph num="(1)"> <text>Be on the letterhead of the accredited dental hygiene program;</text> </paragraph> <paragraph num="(2)"> <text>Contain a raised embossed school seal; and</text> </paragraph> <paragraph num="(3)"> <text>Contain the original signature of either:</text> <paragraph num="(a)"> <text>The Dean of the accredited dental hygiene program; or</text> </paragraph> <paragraph num="(b)"> <text>The head of the dental hygiene department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The experience requirements of §B2(d) of this regulation may not be obtained as an undergraduate dental hygiene student.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Display and Location of Recognition to Administer Local Anesthesia."> <text>A dental hygienist recognized by the Board as qualified to administer local anesthesia shall display the recognition conspicuously in the office where the holder is engaged in practice.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Nitrous Oxide."> <paragraph num="A."> <text>Classification of Board Recognition. The Board shall recognize the classification of recognized to monitor nitrous oxide.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist may not administer nitrous oxide unless recognized by the Board as being qualified to do so as provided in this chapter.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist who is recognized by the Board to administer nitrous oxide may do so provided that the administration of nitrous oxide is under the supervision of a dentist who:</text> <paragraph num="(1)"> <text>Is physically on the premises; and</text> </paragraph> <paragraph num="(2)"> <text>Prescribes the administration of nitrous oxide by the dental hygienist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The supervising dentist and the dental hygienist who administers nitrous oxide shall insure that the patient retains the ability to independently and continuously maintain an airway and respond purposely to physical stimulation and verbal commands.</text> </paragraph> <paragraph num="E."> <text>A dental hygienist who administers or monitors a patient to whom nitrous oxide has been administered shall enter the details of the procedure during and after the procedure into the patient’s record.</text> </paragraph> <paragraph num="F."> <text>A dental hygienist may not monitor or administer nitrous oxide to more than one patient at a time.</text> </paragraph> <paragraph num="G."> <text>A dental hygienist who administers nitrous oxide to a patient or who monitors a patient to whom nitrous oxide has been administered may not:</text> <paragraph num="(1)"> <text>Treat any other patient during the course of the administration or monitoring; or</text> </paragraph> <paragraph num="(2)"> <text>Leave the operatory during the administration or monitoring except in emergency circumstances.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A dental hygienist who is recognized to either monitor or administer nitrous oxide may remove the patient from nitrous oxide when the procedures have been completed.</text> </paragraph> <paragraph num="I."> <text>If a dental hygienist either monitors or administers nitrous oxide, the supervising dentist shall remain in the dental office and in close proximity to be summoned in the event of an emergency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Qualifications for Board Recognition to Administer Nitrous Oxide."> <paragraph num="A."> <text>A dental hygienist who wishes to receive recognition by the Board as being qualified to administer nitrous oxide shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dental hygiene in this State; and</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a Board-approved course of instruction as outlined in Regulation .20 of this chapter that documents training of at least 6 hours consisting of at least:</text> <paragraph num="(a)"> <text>4 hours of didactic classroom training; and</text> </paragraph> <paragraph num="(b)"> <text>2 hours of clinical training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist shall pass a written and clinical examination administered by the Board-approved course with an overall passing grade of at least 75 percent in both the written examination portion and the clinical examination portion.</text> </paragraph> <paragraph num="C."> <text>The Board-approved course of instruction in administering nitrous oxide may be obtained by:</text> <paragraph num="(1)"> <text>A dental hygienist while an undergraduate student in a Board-approved school for dental hygiene that is accredited by the American Dental Association Committee on Dental Accreditation or its successor organization; or</text> </paragraph> <paragraph num="(2)"> <text>A dental hygienist who completes the course offered by an accredited dental hygiene program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the Requirements outlined in §§A—C of this regulation, an applicant for recognition to administer nitrous oxide shall take and pass the CDCA Nitrous Oxide Examination for Dental Hygienists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Recognition to Monitor a Patient to Whom Nitrous Oxide Has Been Administered."> <paragraph num="A."> <text>A dental hygienist who holds a Board recognition to monitor a patient to whom nitrous oxide has been administered may, on and after October 1, 2016, continue to monitor a dentist’s administration of nitrous oxide to a patient, but may not administer nitrous oxide to a patient unless the dental hygienist holds a recognition to administer nitrous oxide.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist who is recognized to monitor a patient to whom nitrous oxide has been administered may not increase the nitrous levels.</text> </paragraph> <paragraph num="C."> <text>The supervising dentist shall discharge the patient upon completion of the procedures.</text> </paragraph> <paragraph num="D."> <text>Beginning on October 1, 2016, the Board may not issue a recognition to monitor nitrous oxide.</text> </paragraph> <paragraph num="E."> <text>A dental hygienist may not administer nitrous oxide to a patient unless recognized by the Board as being qualified to do so as provided in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Board-Approved Course of Instruction for Administering Nitrous Oxide."> <text>The 6-hour Board-approved course of instruction shall include but not be limited to the following:</text> <paragraph num="A."> <text>4 hours of didactic classroom training, including at least the following:</text> <paragraph num="(1)"> <text>The history, philosophy, and psychology of nitrous oxide minimal sedation;</text> </paragraph> <paragraph num="(2)"> <text>The definition and descriptions of the physiological and psychological aspects of pain and anxiety;</text> </paragraph> <paragraph num="(3)"> <text>Concepts and management of pain and anxiety;</text> </paragraph> <paragraph num="(4)"> <text>Indications and contraindications for nitrous oxide sedation;</text> </paragraph> <paragraph num="(5)"> <text>Anatomy and physiology of pediatric and adult respiration;</text> </paragraph> <paragraph num="(6)"> <text>Medical assessment of a patient before administration of nitrous oxide;</text> </paragraph> <paragraph num="(7)"> <text>Moderate sedation, deep sedation, and general anesthesia versus nitrous oxide;</text> </paragraph> <paragraph num="(8)"> <text>Pharmacological and physiological effects of nitrous oxide including drug interactions;</text> </paragraph> <paragraph num="(9)"> <text>A description of the stages of drug induced central nervous system depression through all levels of consciousness and unconsciousness with emphasis on the distinction between the conscious and unconscious state;</text> </paragraph> <paragraph num="(10)"> <text>Administering and monitoring the flow of nitrous oxide, including the monitoring of a patient’s vital functions;</text> </paragraph> <paragraph num="(11)"> <text>Recognition and management of complications and medical emergencies;</text> </paragraph> <paragraph num="(12)"> <text>Occupational exposure; and</text> </paragraph> <paragraph num="(13)"> <text>Preventing, recognizing, and managing possible complications of inhalation sedation; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>2 hours of clinical training, including the direct observation of the performance of procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Out-of-State Certification to Administer Nitrous Oxide."> <paragraph num="A."> <text>A dental hygienist holding an active certification or who is otherwise recognized in another state to administer nitrous oxide may be granted recognition to administer nitrous oxide without taking and passing the Board-approved course if the dental hygienist:</text> <paragraph num="(1)"> <text>Has successfully administered nitrous oxide to at least 10 dental patients within the 2-year period immediately preceding the date of application without complications;</text> </paragraph> <paragraph num="(2)"> <text>Has passed the CDCA Nitrous Oxide Examination for Dental Hygienists; and</text> </paragraph> <paragraph num="(3)"> <text>Applies for and receives recognition by the Board as qualified to administer nitrous oxide.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The experience requirements of §A(1) of this regulation may not be obtained as an undergraduate dental hygiene student.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Administering Nitrous Oxide to a Patient."> <paragraph num="A."> <text>A dental hygienist who administers nitrous oxide shall enter clinic details of the procedure during and after the procedure into the patient’s dental record.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist may not administer nitrous oxide to more than one patient at a time.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist who administers nitrous oxide to a patient may not:</text> <paragraph num="(1)"> <text>Treat any other patient during the course of the initiation, adjustment, monitoring, or termination of the flow of nitrous oxide; or</text> </paragraph> <paragraph num="(2)"> <text>Leave the operatory during the initiation, adjustment, monitoring, or termination of the flow of nitrous oxide except in emergency circumstances.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The dental hygienist may remove the patient from nitrous oxide when the procedures have been completed.</text> </paragraph> <paragraph num="E."> <text>The supervising dentist shall remain in the dental office and in appropriate proximity to be summoned in the event of an emergency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Emergency Response Plan for Administering Nitrous Oxide."> <paragraph num="A."> <text>A dentist that utilizes a dental hygienist to administer nitrous oxide shall have a medical emergency plan for the dental hygienist to follow in the event of an emergency.</text> </paragraph> <paragraph num="B."> <text>In the event of an emergency, the dental hygienist may turn off the nitrous oxide and administer 100 percent oxygen.</text> </paragraph> <paragraph num="C."> <text>In the event of an emergency the dental hygienist shall immediately summon the supervising dentist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Continuing Education Credit for Nitrous Oxide Course."> <text>A dental hygienist who has successfully completed the following since graduating from an approved school of dental hygiene may receive continuing education credit toward renewal of their dental hygiene license:</text> <paragraph num="A."> <text>The 6-hour Board-approved course of instruction for administering nitrous oxide; and</text> </paragraph> <paragraph num="B."> <text>The CDCA Nitrous Oxide Examination for Dental Hygienists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Application for Board Recognition as Qualified to Administer Nitrous Oxide."> <paragraph num="A."> <text>A dental hygienist shall submit a completed Board-approved application with the Board to be recognized as qualified to administer nitrous oxide.</text> </paragraph> <paragraph num="B."> <text>Recognized as Qualified to Administer Nitrous Oxide.</text> <paragraph num="(1)"> <text>Not Certified or Otherwise Recognized in Another State. A dental hygienist who applies to be recognized as qualified to administer nitrous oxide and who is not certified or otherwise recognized in another state to administer nitrous oxide shall submit to the Board:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Proof of completion of a 6-hour Board-approved course of instruction in administering nitrous oxide in the form of a letter from an accredited dental hygiene program indicating that the applicant has:</text> <paragraph num="(i)"> <text>Successfully completed the course; and</text> </paragraph> <paragraph num="(ii)"> <text>Received an overall passing grade of at least 75 percent in both the course's written examination and the course's clinical examination;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A certified examination score from the CDCA indicating that the applicant has passed the CDCA Nitrous Oxide Examination for Dental Hygienists.</text> </paragraph> <paragraph num="(d)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(e)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Recognized as Qualified to Administer Nitrous Oxide by Virtue of Being Recognized in Another State. A dental hygienist who applies to be recognized as qualified to administer nitrous oxide by virtue of being certified or otherwise recognized in another state to administer nitrous oxide shall submit the following to the Board:</text> <paragraph num="(a)"> <text>A Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>A certified copy of the dental hygienist's most recent license or certification from the state of licensure or certification, indicating that the dental hygienist holds a current license or certification to administer nitrous oxide;</text> </paragraph> <paragraph num="(c)"> <text>A certified examination score from the CDCA indicating that the applicant has passed the CDCA Nitrous Oxide Examination for Dental Hygienists;</text> </paragraph> <paragraph num="(d)"> <text>An affidavit indicating that the dental hygienist has within the 2-year period immediately preceding the date of the application successfully administered nitrous oxide to at least 10 dental patients without complications;</text> </paragraph> <paragraph num="(e)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(f)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The affidavit referenced in §B(2)(d) of this regulation shall contain the name, business address, and business telephone number of each dentist who supervised the applicant’s administration of nitrous oxide, as well as a statement indicating whether the dentist is currently practicing dentistry, is retired, or is deceased;</text> </paragraph> <paragraph num="D."> <text>The letter from the accredited dental hygiene program referenced in §B(1)(b) of this regulation shall:</text> <paragraph num="(1)"> <text>Be on the letterhead of the accredited dental hygiene program;</text> </paragraph> <paragraph num="(2)"> <text>Contain a raised embossed school seal; and</text> </paragraph> <paragraph num="(3)"> <text>Contain the original signature of either:</text> <paragraph num="(a)"> <text>The Dean of the accredited dental hygiene program; or</text> </paragraph> <paragraph num="(b)"> <text>The head of the dental hygiene department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The fee required under §B(1)(d) of this regulation shall be waived for a dental hygienist who applies for recognition to administer nitrous oxide if the dental hygienist:</text> <paragraph num="(1)"> <text>Holds a recognition issued by the Board to monitor a patient to whom nitrous oxide has been administered;</text> </paragraph> <paragraph num="(2)"> <text>Has taken and passed the CDCA Nitrous Oxide Examination for Dental Hygienists; and</text> </paragraph> <paragraph num="(3)"> <text>Otherwise meets the requirements to administer nitrous oxide established under this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Display and Location of Recognition as Qualified to Monitor or Administer Nitrous Oxide."> <text>A dental hygienist recognized by the Board as qualified to either monitor or administer nitrous oxide shall display the recognition conspicuously in the office where the holder is engaged in practice.</text> </regulation> <regulation prefix="Regulation" num=".27" heading="Authority to Prescribe and Administer Medication."> <paragraph num="A."> <text>The Board shall recognize the joint classification of recognized to prescribe and administer medication.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist may not prescribe or administer medication unless recognized by the Board as being qualified to do so as provided in this chapter.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist may not dispense medication.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Prescribing Medication."> <paragraph num="A."> <text>A dental hygienist who is recognized by the Board to prescribe medication may, under the general supervision of a dentist, prescribe:</text> <paragraph num="(1)"> <text>Topical and systemic types of prescription or over-the-counter fluoride preparations;</text> </paragraph> <paragraph num="(2)"> <text>Topical antimicrobial rinses; and</text> </paragraph> <paragraph num="(3)"> <text>Ibuprofen not exceeding 600 mg every 6 hours for up to 3 days after nonsurgical periodontal therapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist may not prescribe a drug:</text> <paragraph num="(1)"> <text>That is classified as a controlled dangerous substance under Criminal Law Article, Title 5, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>That is a controlled dangerous substance as defined by 21 U.S.C. §812; or</text> </paragraph> <paragraph num="(3)"> <text>The prescription of which requires a federal Drug Enforcement Agency registration.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dental hygienist may prescribe a medication under §A of this regulation under a standing order in the patient’s record that is authorized by the supervising dentist, if the dental hygienist includes the following information in the patient’s record:</text> <paragraph num="(1)"> <text>The name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>The dosage of the medication;</text> </paragraph> <paragraph num="(3)"> <text>The date and time the medication was administered;</text> </paragraph> <paragraph num="(4)"> <text>The route by which the medication was administered; and</text> </paragraph> <paragraph num="(5)"> <text>Any allergies that the patient has.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The standing order entered into the patient’s record by the supervising dentist shall include at least:</text> <paragraph num="(1)"> <text>The name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>The dosage of the medication; and</text> </paragraph> <paragraph num="(3)"> <text>The particular circumstances under which the medication should be administered.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the requirements of §D of this regulation, the standing order entered into the patient’s record by the supervising dentist shall identify any allergies that the patient has.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Administering Medication."> <paragraph num="A."> <text>A dental hygienist who is recognized by the Board to administer medication may, under the general supervision of a dentist, administer medication including:</text> <paragraph num="(1)"> <text>Topical and systemic types of prescription or over-the-counter fluoride preparations;</text> </paragraph> <paragraph num="(2)"> <text>Topical antimicrobial rinses;</text> </paragraph> <paragraph num="(3)"> <text>Ibuprofen not exceeding 600 mg every 6 hours for up to 3 days after nonsurgical periodontal therapy;</text> </paragraph> <paragraph num="(4)"> <text>Premedication antibiotics by mouth as required for dental treatment;</text> </paragraph> <paragraph num="(5)"> <text>Subgingival antibiotics and antimicrobials; and</text> </paragraph> <paragraph num="(6)"> <text>Nonopioid pain medication.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist may not administer a medication:</text> <paragraph num="(1)"> <text>That is classified as a controlled dangerous substance under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, or a controlled substance as defined by 21 U.S.C. §812;</text> </paragraph> <paragraph num="(2)"> <text>The prescription of which requires a federal Drug Enforcement Agency Registration; or</text> </paragraph> <paragraph num="(3)"> <text>Except for local anesthesia that is administered by intramuscular, subcutaneous, intravenous, or intradermal injection and administered in accordance with Health Occupations Article, §4-206.1 or 4-206.3, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dental hygienist may administer a medication under §A of this regulation under a standing order in the patient’s record that is authorized by the supervising dentist, if the dental hygienist includes the following information in the patient’s record:</text> <paragraph num="(1)"> <text>The name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>The dosage of the medication;</text> </paragraph> <paragraph num="(3)"> <text>The date and time the medication was administered; and</text> </paragraph> <paragraph num="(4)"> <text>The route by which the medication was administered.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The standing order entered into the patient’s record by the supervising dentist shall include at least the:</text> <paragraph num="(1)"> <text>Name of the medication;</text> </paragraph> <paragraph num="(2)"> <text>Dosage of the medication;</text> </paragraph> <paragraph num="(3)"> <text>Particular circumstances under which the medication should:</text> <paragraph num="(a)"> <text>Be administered; or</text> </paragraph> <paragraph num="(b)"> <text>Not be administered.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Qualifications for Board Recognition to Prescribe and Administer Medication."> <paragraph num="A."> <text>A dental hygienist who wishes to receive recognition by the Board as being qualified to prescribe and administer medication shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dental hygiene in this State; and</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a Board-approved course of at least 4 hours consisting of at least 4 hours of didactic training.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dental hygienist shall pass a written examination administered by the Board-approved course with an overall passing grade of at least 75 percent.</text> </paragraph> <paragraph num="C."> <text>The examination shall consist of at least 25 questions with a time limit of no more than 60 minutes to complete the examination.</text> </paragraph> <paragraph num="D."> <text>The Board-approved course of instruction in prescribing and administering medication may be obtained by:</text> <paragraph num="(1)"> <text>A dental hygienist while an undergraduate student in a Board-approved school for dental hygiene that is accredited by the American Dental Association Committee on Dental Accreditation or its successor organization; or</text> </paragraph> <paragraph num="(2)"> <text>A dental hygienist who completes the course offered by an accredited dental hygiene program.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The course offered by the accredited dental hygiene program may be completed in-person or online.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Board-Approved Course of Instruction for Prescribing and Administering Medication."> <text>The 4-hour Board-approved course of instruction shall include but not be limited to the following:</text> <paragraph num="A."> <text>Responsible medication prescribing;</text> </paragraph> <paragraph num="B."> <text>Accuracy in prescription writing;</text> </paragraph> <paragraph num="C."> <text>Electronic prescribing;</text> </paragraph> <paragraph num="D."> <text>Telephonic prescribing;</text> </paragraph> <paragraph num="E."> <text>Professional accountability;</text> </paragraph> <paragraph num="F."> <text>Risk management;</text> </paragraph> <paragraph num="G."> <text>Safeguarding prescription pads;</text> </paragraph> <paragraph num="H."> <text>Application for a National Provider Identifier number;</text> </paragraph> <paragraph num="I."> <text>Principles of and prohibitions against drug dispensing by dental hygienists;</text> </paragraph> <paragraph num="J."> <text>Chairside medication administration;</text> </paragraph> <paragraph num="K."> <text>Proper storage and disposal of medications;</text> </paragraph> <paragraph num="L."> <text>Labeling requirements;</text> </paragraph> <paragraph num="M."> <text>Drug classifications and scheduling;</text> </paragraph> <paragraph num="N."> <text>Controlled substances:</text> <paragraph num="(1)"> <text>The role of the federal Drug Enforcement Agency; and</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Prescription Drug Monitoring Program;</text> </paragraph> </paragraph> <paragraph num="O."> <text>Recognizing and addressing drug abuse;</text> </paragraph> <paragraph num="P."> <text>Review of medical history;</text> </paragraph> <paragraph num="Q."> <text>Questioning patients for safe prescribing;</text> </paragraph> <paragraph num="R."> <text>Drug Interactions;</text> </paragraph> <paragraph num="S."> <text>Premedication — antibiotic prophylaxis;</text> </paragraph> <paragraph num="T."> <text>American Dental Hygienists’ Association guidelines for prescribing and administering medication;</text> </paragraph> <paragraph num="U."> <text>Drug recommendations and dosing;</text> </paragraph> <paragraph num="V."> <text>Adverse reactions and hypersensitivities;</text> </paragraph> <paragraph num="W."> <text>Medical emergencies and emergency drugs;</text> </paragraph> <paragraph num="X."> <text>Adjuvant therapy for nonsurgical periodontal treatment:</text> </paragraph> <paragraph num="Y."> <text>Evidence-based decision making for drug therapy;</text> </paragraph> <paragraph num="Z."> <text>Conditions and recommended therapies;</text> </paragraph> <paragraph num="AA."> <text>Pharmacokinetics — the effect of drugs on the body;</text> </paragraph> <paragraph num="BB."> <text>Pharmacodynamics — drug processing;</text> </paragraph> <paragraph num="CC."> <text>Specific medications:</text> <paragraph num="(1)"> <text>Local anesthetics:</text> </paragraph> <paragraph num="(2)"> <text>Antimicrobials — subgingival and systemic;</text> </paragraph> <paragraph num="(3)"> <text>Nonsteroidal anti-inflammatory drugs;</text> </paragraph> <paragraph num="(4)"> <text>Fluoride preparations;</text> </paragraph> <paragraph num="(5)"> <text>Over-the-counter medications;</text> </paragraph> <paragraph num="(6)"> <text>Nutraceuticals and herbal supplements; and</text> </paragraph> <paragraph num="(7)"> <text>Vitamin and mineral supplements;</text> </paragraph> </paragraph> <paragraph num="DD."> <text>Record-keeping requirements for medications prescribed and administered; and</text> </paragraph> <paragraph num="EE."> <text>Patient follow-up care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Out-of-State Certification to Prescribe and Administer Medication."> <paragraph num="A."> <text>A dental hygienist holding an active certification or who is otherwise recognized in another state to prescribe and administer medication may be granted recognition to prescribe and administer medication without taking and passing the Board-approved course if the dental hygienist:</text> <paragraph num="(1)"> <text>Has prescribed medication to at least 100 dental patients within the 2-year period immediately preceding the date of application without complications;</text> </paragraph> <paragraph num="(2)"> <text>Has administered medication to at least 100 dental patients within the 2-year period immediately preceding the date of application without complications; and</text> </paragraph> <paragraph num="(3)"> <text>Applies for and receives recognition by the Board as qualified to prescribe and administer medication.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The application referred to in §A(3) of this regulation shall include a signed Board-approved affidavit affirming the experience requirements.</text> </paragraph> <paragraph num="C."> <text>The experience requirements of §A(1) and (2) of this regulation may not be obtained as an undergraduate dental hygiene student.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Emergency Response Plan for Administering Medication."> <paragraph num="A."> <text>A dentist who supervises a dental hygienist who is recognized by the Board to prescribe and administer medication shall have a medical emergency plan for the dental hygienist to follow in the event of an emergency.</text> </paragraph> <paragraph num="B."> <text>In the event of an emergency, the dental hygienist shall immediately summon the supervising dentist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Continuing Education Credit for Board-Approved Course of Instruction for Prescribing and Administering Medication."> <text>A dental hygienist who successfully completes the 4-hour Board-approved course of instruction for prescribing and administering medication since graduating from an approved school of dental hygiene may receive 4 hours of continuing education credit toward renewal of their dental hygiene license.</text> </regulation> <regulation prefix="Regulation" num=".35" heading="Application for Board Recognition to Prescribe and Administer Medication."> <paragraph num="A."> <text>A dental hygienist shall submit a completed Board-approved application with the Board to be recognized as qualified to prescribe and administer medication.</text> </paragraph> <paragraph num="B."> <text>Recognized as Qualified to Prescribe and Administer Medication.</text> <paragraph num="(1)"> <text>Not Certified or Otherwise Recognized in Another State. A dental hygienist who applies to be recognized as qualified to prescribe and administer medication and who is not certified or otherwise recognized in another state to prescribe and administer medication shall submit to the Board:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Proof of completion of a 4-hour Board-approved course of instruction in prescribing and administering medication in the form of a letter from an accredited dental hygiene program indicating that the applicant has:</text> <paragraph num="(i)"> <text>Successfully completed the course; and</text> </paragraph> <paragraph num="(ii)"> <text>Received an overall passing grade of at least 75 percent in the course’s written examination;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(d)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Recognized as Qualified to Prescribe and Administer Medication by Virtue of Being Recognized in Another State. A dental hygienist who applies to be recognized as qualified to prescribe and administer medication by virtue of being certified or otherwise recognized as qualified in another state to prescribe and administer medication shall submit to the Board:</text> <paragraph num="(a)"> <text>A Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>A certified copy of the dental hygienist’s most recent license or certification from the state of licensure or certification, indicating that the dental hygienist holds a current license or certification to prescribe and administer medication;</text> </paragraph> <paragraph num="(c)"> <text>An affidavit indicating that the dental hygienist has within the 2-year period immediately preceding the date of the application successfully:</text> <paragraph num="(i)"> <text>Prescribed medication to at least 100 patients without complications; and</text> </paragraph> <paragraph num="(ii)"> <text>Administered medication to at least 100 patients without complications;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A fee as specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(e)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The affidavit referenced in §B(2)(c) of this regulation shall contain the name, business address, and business telephone number of each dentist who supervised the applicant’s prescribing and administering medication as well as a statement indicating whether the dentist is currently practicing dentistry, is retired, or is deceased.</text> </paragraph> <paragraph num="D."> <text>The letter from the accredited dental hygiene program referenced in §B(1)(b) of this regulation shall:</text> <paragraph num="(1)"> <text>Be on the letterhead of the accredited dental hygiene program;</text> </paragraph> <paragraph num="(2)"> <text>Contain a raised embossed school seal; and</text> </paragraph> <paragraph num="(3)"> <text>Contain the original signature of either:</text> <paragraph num="(a)"> <text>The dean of the accredited dental hygiene program; or</text> </paragraph> <paragraph num="(b)"> <text>The head of the dental hygiene department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Issuance of Recognition to Prescribe and Administer Medication."> <paragraph num="A."> <text>The Board may issue a recognition as qualified to prescribe and administer medication to a dental hygienist who is not certified or otherwise recognized in another state after the Board’s review of:</text> <paragraph num="(1)"> <text>The applicant’s application;</text> </paragraph> <paragraph num="(2)"> <text>The applicant’s qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may issue a recognition as qualified to prescribe and administer medication to a dental hygienist who is certified or otherwise recognized in another state after the Board’s review of:</text> <paragraph num="(1)"> <text>The applicant’s application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant’s qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Continuing Education and Renewal for Prescribing and Administering Medication."> <paragraph num="A."> <text>A dental hygienist is not required to renew the Board recognition to prescribe and administer medication.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist who has successfully completed the 4-hour Board-approved course of instruction for recognition to prescribe and administer medication since graduating from an approved school of dental hygiene may receive 4-hours of continuing education credit toward renewal of their dental hygiene license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Display and Location of Recognition to Prescribe and Administer Medication."> <text>A dental hygienist recognized by the Board to prescribe and administer medication shall display the recognition conspicuously in the office where the holder is engaged in practice.</text> </regulation> <regulation prefix="Regulation" num=".39" heading="Violations."> <paragraph num="A."> <text>Subject to the hearing provisions of Health Occupations Article, §4-318, Annotated Code of Maryland, the Board may take the following action against a dental hygienist who violates any provision of this chapter or who violates any provision of Health Occupations Article, §4-315(b), Annotated Code of Maryland:</text> <paragraph num="(1)"> <text>Deny, suspend, or revoke the recognition to administer local anesthesia;</text> </paragraph> <paragraph num="(2)"> <text>Deny the privilege to perform manual curettage in conjunction with scaling and root planning;</text> </paragraph> <paragraph num="(3)"> <text>Deny, suspend, or revoke the recognition to administer nitrous oxide;</text> </paragraph> <paragraph num="(4)"> <text>Suspend or revoke the recognition to monitor nitrous oxide;</text> </paragraph> <paragraph num="(5)"> <text>Deny, suspend, or revoke the recognition to prescribe and administer medication;</text> </paragraph> <paragraph num="(6)"> <text>Issue a reprimand; and</text> </paragraph> <paragraph num="(7)"> <text>Take disciplinary action under Health Occupations Article, §4-315(b), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the action authorized under §A of this regulation, the Board may take formal or informal disciplinary action as specified in COMAR 10.44.07.</text> </paragraph> <paragraph num="C."> <text>Failure to comply with this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".40" heading="Summary Suspension."> <paragraph num="A."> <text>The Board may order the summary suspension of the recognition qualified to administer local anesthesia, the privilege to perform manual curettage in conjunction with scaling and root planning, the recognition qualified to monitor nitrous oxide, the recognition to administer nitrous oxide, or the recognition to prescribe and administer medication if the Board:</text> <paragraph num="(1)"> <text>Finds that the public health, safety, or welfare imperatively requires emergency action; and</text> </paragraph> <paragraph num="(2)"> <text>Promptly gives the licensee:</text> <paragraph num="(a)"> <text>Written notice of the suspension, the finding, and the reasons that support the finding; and</text> </paragraph> <paragraph num="(b)"> <text>An opportunity to be heard.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Service of the notice of the suspension, the finding, the reasons that support the finding, and the notice of the opportunity to be heard may be effected upon the holder of the recognition by:</text> <paragraph num="(1)"> <text>Personal service; or</text> </paragraph> <paragraph num="(2)"> <text>Written notice sent by certified mail and regular mail to the recognition holder's address on file with the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Service made pursuant to §B(2) of this regulation shall be effective upon mailing.</text> </paragraph> <paragraph num="D."> <text>The methods of service provided in this regulation are in addition to and not exclusive of any other means of service that are reasonably calculated to provide notice.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-205, 4-206.1, 4-206.2 4-206.3, 4-206.4, and 12-101, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 18, 1977 (4:24 Md. R. 1806)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 22, 1985 (12:8 Md. R. 803)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective May 31, 2010 (37:11 Md. R. 765)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 21, 2002 (29:1 Md. R. 23); May 31, 2010 (37:11 Md. R. 765)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 21, 2002 (29:1 Md. R. 23); May 31, 2010 (37:11 Md. R. 765)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04—.16 adopted effective May 31, 2010 (37:11 Md. R. 765)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.16 repealed and new Regulations .01—.28 adopted effective April 29, 2013 (40:8 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 24, 2016 (43:23 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 5, 2022 (49:18 Md. R. 819)</annotation> </annotations> </chapter> <chapter num="05" heading="Licensure for Dentists Licensed in Another State"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ADEX” means the American Board of Dental Examiners, Inc., or its successor organization.</text> </paragraph> <paragraph num="(2)"> <text>“ADLEX” means the American Dental Licensing Examination, which includes both a written component and a clinic component, designed and developed by ADEX, or its successor examination.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifications for All Applicants."> <text>A dentist holding an active license in any other state may be granted a license in Maryland if the applicant:</text> <paragraph num="A."> <text>Meets the requirements of Health Occupations Article, §4-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Is of good moral character;</text> </paragraph> <paragraph num="C."> <text>Holds a Degree of Doctor of Dental Surgery, Doctor of Dental Medicine, or the equivalent from a college or university that is:</text> <paragraph num="(1)"> <text>Authorized by any state or province of Canada to grant the degree; and</text> </paragraph> <paragraph num="(2)"> <text>Recognized by the Board as:</text> <paragraph num="(a)"> <text>Requiring adequate preprofessional collegiate training; and</text> </paragraph> <paragraph num="(b)"> <text>Maintaining an acceptable course of dental instruction; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Meets the qualifications otherwise required by Health Occupations Article, Title 4, Annotated Code of Maryland, for an active general license to practice dentistry.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure of Dentists Who Have Passed the ADLEX Examination."> <paragraph num="A."> <text>In addition to meeting the requirements of Regulation .02 of this chapter, a dentist holding an active license in any other state shall be issued a license if the applicant:</text> <paragraph num="(1)"> <text>Has passed the ADLEX with a score of 75 or greater in each required section; and</text> </paragraph> <paragraph num="(2)"> <text>Has passed the Maryland Dental Jurisprudence Examination given by the Board or its designee with a score of 75 or greater on each section of the examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, a candidate holding an active license in another state, or who has ever held an active license in another state, shall provide adequate evidence satisfactory to the Board that the candidate:</text> <paragraph num="(1)"> <text>Is not being investigated by a disciplinary authority of another state:</text> </paragraph> <paragraph num="(2)"> <text>Does not have charges pending against the applicant’s license;</text> </paragraph> <paragraph num="(3)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(4)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure of Dentists Who Have Not Passed the ADLEX Examination."> <paragraph num="A."> <text>In addition to meeting the requirements of Regulation .02 of this chapter, a dentist holding an active license in another state who has not passed the ADLEX examination with a score of 75 or greater in each required section of the ADLEX shall be issued a license if the applicant:</text> <paragraph num="(1)"> <text>For the 5 preceding years has been actively engaged in practicing dentistry for at least 850 hours on average per year;</text> </paragraph> <paragraph num="(2)"> <text>Has passed an examination with a clinical component as a requirement for licensure in another state;</text> </paragraph> <paragraph num="(3)"> <text>Has passed a comprehensive written examination on applied clinical diagnosis and treatment planning administered by ADEX with a score of 75 or greater in each required section; and</text> </paragraph> <paragraph num="(4)"> <text>Has passed the Maryland Dental Jurisprudence Examination given by the Board or its designee with a score of 75 or greater percent on each section of the examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The practice of dentistry in the armed forces, the practice of dentistry in state and federal programs, participation in post-graduate intern programs, or participation in residency programs within the 5 years preceding application counts toward the required hours of active practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedures."> <paragraph num="A."> <text>An applicant who has passed the ADLEX with a score of 75 or greater in each required section shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="(4)"> <text>Certified proof of dental education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature, do not require a raised embossed seal;</text> </paragraph> <paragraph num="(5)"> <text>A certified examination score of the ADLEX and, if requested by the Board, a specific point breakdown by procedure including penalty deductions if available;</text> </paragraph> <paragraph num="(6)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant holds an active dental license or ever held an active dental license indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(8)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who has not passed the ADLEX with a score of 75 or greater in each required section of the ADLEX shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="(4)"> <text>Certified proof of dental education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature, do not require a raised embossed seal;</text> </paragraph> <paragraph num="(5)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant holds an active dental license or ever held an active dental license indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A notarized affidavit or other evidence satisfactory to the Board indicating that for the 5 preceding years the applicant has been actively engaged in practicing dentistry for at least 850 hours on average per year;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(8)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fees."> <paragraph num="A."> <text>The application fee shall accompany the application and is specified in COMAR 10.44.20.</text> </paragraph> <paragraph num="B."> <text>The application fee is nonrefundable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-303.1(d) and 4-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 25, 1977 (4:11 Md. R. 868)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 recodified to Regulation .01-1 and the Preface recodified to Regulation .01 in November 1990</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 3, 1990 (17:17 Md. R. 2081); April 19, 1999 (26:8 Md. R. 615); September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 12, 1982 (9:7 Md. R. 711); April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective April 12, 1982 (9:7 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective September 3, 1990 (17:17 Md. R. 2081)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed and new Regulations .01 — .05 adopted effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed and new Regulations .01 — .06 adopted as an emergency provision effective October 1, 2012 (39:22 Md. R. 1426); adopted permanently effective December 24, 2012 (39:25 Md. R. 1613)</annotation> </annotations> </chapter> <chapter num="06" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Dentist” means an individual who holds a current license to practice dentistry in Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“General dentist” means a dentist not recognized by the Board as a specialist in an area of dental specialty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Prohibition of Deceptive or Misleading Statements or Claims."> <paragraph num="A."> <text>A dentist may not, on behalf of himself, his partner, or his associate, or for any other dentist affiliated with him, use or participate in the use of any form of public communication which contains a deceptive or misleading statement or claim.</text> </paragraph> <paragraph num="B."> <text>Deceptive or misleading statements or claims are those that:</text> <paragraph num="(1)"> <text>Contain a material misrepresentation of fact;</text> </paragraph> <paragraph num="(2)"> <text>Fail to state any fact necessary to make the statement not misleading;</text> </paragraph> <paragraph num="(3)"> <text>Are intended or are likely to create unjustified expectations;</text> </paragraph> <paragraph num="(4)"> <text>State or imply that a dentist is a certified or recognized specialist other than as recognized by the Board;</text> </paragraph> <paragraph num="(5)"> <text>State or imply superior service;</text> </paragraph> <paragraph num="(6)"> <text>Contain a representation or implication that is likely to cause an ordinary prudent person to misunderstand or to be deceived;</text> </paragraph> <paragraph num="(7)"> <text>Contain statistical data or other information based on past performance coupled with an explicit representation that the data or information indicates a likelihood of future success;</text> </paragraph> <paragraph num="(8)"> <text>Contain or imply any guarantee of satisfaction, except the guarantee to return a fee if the patient is not satisfied with the treatment rendered;</text> </paragraph> <paragraph num="(9)"> <text>Use electronic media, including television, radio, and motion pictures, in a manner inconsistent with these regulations and the following criteria:</text> <paragraph num="(a)"> <text>Broadcast advertising shall be communicated to the public only over radio or television stations that are approved by the Federal Communications Commission or over cable television,</text> </paragraph> <paragraph num="(b)"> <text>Broadcast advertisements shall be prerecorded, and approved for broadcast by the advertising dentist, and</text> </paragraph> <paragraph num="(c)"> <text>A recording of the actual transmission shall be retained by the advertising dentist for a period of 3 years;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Fail to include the name of a responsible licensed dentist who provides dental services at the location advertised; or</text> </paragraph> <paragraph num="(11)"> <text>State or imply that a dentist practices in an area of dental specialty unless the dentist:</text> <paragraph num="(a)"> <text>Is recognized by the Board as a specialist in the area advertised,</text> </paragraph> <paragraph num="(b)"> <text>Includes in the advertisement a disclaimer that the dentist is not recognized by the Board as a specialist in the area of practice advertised, or</text> </paragraph> <paragraph num="(c)"> <text>Includes in the advertisement a statement that the dentist is a general dentist.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fees."> <text>A statement regarding fees shall be considered deceptive or misleading if the dentist:</text> <paragraph num="A."> <text>Renders the service at more than the fees advertised;</text> </paragraph> <paragraph num="B."> <text>Fails to offer the service at the fee advertised for a reasonable period of time following the advertisement unless a specific time limit is included in the original advertisement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibility."> <text>A dentist shall be responsible for an advertisement of service regardless of whether the advertising has been generated by him personally, by his employees, or by a proprietorship, partnership, corporation, union, public school clinic, state institution, or eleemosynary institution which uses his services.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties for Violation."> <text>Violations of these regulations pertaining to the use of advertising shall constitute unprofessional conduct and may result in disciplinary action against the dentist as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Retention and Inspection."> <text>A dentist shall:</text> <paragraph num="A."> <text>Retain a copy of all advertising, in the form in which it was published, for a period of 3 years from the date of publication; and</text> </paragraph> <paragraph num="B."> <text>Make the copy available for inspection and copying when requested by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-205, 4-315, and 4-503, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 23, 1981 (8:2 Md. R. 112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 2, 1998 (25:22 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 19, 1990 (17:3 Md. R. 300); November 2, 1998 (25:22 Md. R. 1652)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective July 12, 1998 (25:14 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 10, 2001 (28:24 Md. R. 2129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 16, 2004 (31:16 Md. R. 1255); April 30, 2012 (39:8 Md. R. 536)</annotation> </annotations> </chapter> <chapter num="07" heading="Rules of Procedure for the Disciplinary Process"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Dental Examiners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Advisory letter” means an informal action consisting of a nonpublic letter issued by the Board where the Board has a basis to charge the licensee with disciplinary violations but closes the case by advising the licensee of the basis to charge and admonishes the licensee not to repeat the conduct.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Board of Dental Examiners.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Case resolution conference committee” means a committee composed of members of the Board that makes recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(8)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease doing a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of dentistry or dental hygiene.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Charging document” means a nonpublic document issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Dentistry Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth provisions of the Maryland Dentistry Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Complaint” means information received by the Board which sets out conduct by a licensee which may:</text> <paragraph num="(a)"> <text>Violate the Maryland Dentistry Act; and</text> </paragraph> <paragraph num="(b)"> <text>Be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Consent agreement” means informal action taken by the Board consisting of a nonpublic document which has been negotiated and agreed to by both the licensee and the Board to resolve an administrative, nondisciplinary matter.</text> </paragraph> <paragraph num="(12)"> <text>“Consent order” means a public document issued by the Board which is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(13)"> <text>“Contested case” means a proceeding conducted pursuant to the Administrative Procedure Act.</text> </paragraph> <paragraph num="(14)"> <text>“Disciplinary review committee” means a committee composed of members of the Board that makes recommendations to the Board regarding any disciplinary matter.</text> </paragraph> <paragraph num="(15)"> <text>“Disposition agreement” means a formal nonpublic agreement entered into with an impaired licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions.</text> </paragraph> <paragraph num="(16)"> <text>“Final order” means a public document issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, civil penalty, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Provides for surrender of a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may take.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Imperatively requires emergency action” means a finding by the Board that emergency action be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held.</text> </paragraph> <paragraph num="(18)"> <text>“Informal action” means that the Board closes a case without taking any formal disciplinary action and without issuing a final order.</text> </paragraph> <paragraph num="(19)"> <text>“Investigation” means the gathering of information after the Board receives a complaint against a licensee, which is necessary for the Board to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Dentistry Act.</text> </paragraph> <paragraph num="(20)"> <text>“Letter of education” means informal action consisting of a nonpublic letter to a licensee:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that the licensee's conduct rose to the level of a violation of the Maryland Dental Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of dentistry or dental hygiene.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the licensee's license to practice dentistry or dental hygiene.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of Surrender” may include conditions for the Board's acceptance of the surrender.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Licensure” means the permission granted to an individual by the Board pursuant to the Board's authority under the Maryland Dentistry Act to practice dentistry or dental hygiene in this State which is evidenced by a license issued by the Board.</text> </paragraph> <paragraph num="(23)"> <text>“Maryland Dentistry Act” means Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Notice of initial denial” means a nonpublic document issued by the Board by which an applicant or licensee is notified:</text> <paragraph num="(a)"> <text>That the Board intends to deny:</text> <paragraph num="(i)"> <text>A license;</text> </paragraph> <paragraph num="(ii)"> <text>A change in licensure status; or</text> </paragraph> <paragraph num="(iii)"> <text>Another benefit sought by the licensee;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Of the statutory grounds or other reasons for the denial; and</text> </paragraph> <paragraph num="(c)"> <text>Of any proceedings scheduled before the Board.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Peer review” means an evaluation by appropriate members of a professional association or one of its components of a:</text> <paragraph num="(a)"> <text>Licensee's clinical care; or</text> </paragraph> <paragraph num="(b)"> <text>Dispute between a dentist and a consumer of dental services.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Postdeprivation evidentiary hearing” means a contested case hearing held before the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(27)"> <text>“Postdeprivation show cause hearing” means a nonevidentiary hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why the order for summary suspension issued under State Government Article, §10-226(c)(2), Annotated Code of Maryland, should not remain in effect.</text> </paragraph> <paragraph num="(28)"> <text>“Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why it should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226 (c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take another action that the Board may take.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Preliminary investigation” means the gathering of information necessary for the Board to determine if the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Dentistry Act.</text> </paragraph> <paragraph num="(30)"> <text>“Probation” means a sanction imposed by the Board in a final order, in which the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Subject to certain requirements to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Public document” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(32)"> <text>“Recommended decision” means a nonpublic document issued by an administrative law judge that sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of them, under a delegation by the Board.</text> </paragraph> <paragraph num="(33)"> <text>“Recusal” means the disqualification of a member of the Board from participation in a proceeding because of interest, bias, or other reason.</text> </paragraph> <paragraph num="(34)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, that has been:</text> <paragraph num="(a)"> <text>Charged with violations of Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Notified that the Board intends to initially deny a license, change a licensee's status, or deny another benefit sought by the licensee;</text> </paragraph> <paragraph num="(c)"> <text>Notified of a potential emergency suspension of licensure; or</text> </paragraph> <paragraph num="(d)"> <text>Notified of the opportunity to appear before the Board to respond to allegations by the Board in a contested case.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Reprimand” means a sanction imposed by the Board in a final order in which the Board publicly admonishes the licensee for violating the Maryland Dentistry Act.</text> </paragraph> <paragraph num="(36)"> <text>“Revocation” means a sanction imposed by the Board in a final order in which the licensee's permission to practice dentistry or dental hygiene in Maryland is terminated.</text> </paragraph> <paragraph num="(37)"> <text>“Sanction” means an action taken against a licensee by the Board in a final order, which includes one or a combination of the following:</text> <paragraph num="(a)"> <text>A reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Probation;</text> </paragraph> <paragraph num="(c)"> <text>Suspension or revocation of the license; or</text> </paragraph> <paragraph num="(d)"> <text>A civil penalty.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Show cause hearing” means a nonevidentiary hearing before the Board in which the licensee may demonstrate to the Board why the Board should not:</text> <paragraph num="(a)"> <text>Issue a proposed order;</text> </paragraph> <paragraph num="(b)"> <text>Continue an order currently in effect; or</text> </paragraph> <paragraph num="(c)"> <text>Take an action that the Board may take.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions.</text> </paragraph> <paragraph num="(40)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes that the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(41)"> <text>“Surrender” means the voluntary relinquishment of a license to practice dentistry or dental hygiene that may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(42)"> <text>“Suspension” means a sanction imposed by the Board in a final order in which the licensee's ability to practice dentistry or dental hygiene is temporarily denied for a specific period of time or until certain conditions are met.</text> </paragraph> <paragraph num="(43)"> <text>“Triage Committee” means a committee composed of members of the Board to which newly filed complaints are referred for initial recommendation before review by the Discipline Review Committee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties.</text> </paragraph> <paragraph num="B."> <text>Office of Administrative Hearings proceedings involving the adjudication of a contested case and the administrative law judge's recommended decision are confidential. The respondent may not waive the confidentiality of the proceedings or of the patients whose medical or dental records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is issued by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation of Parties."> <paragraph num="A."> <text>Every party who appears at a formal hearing has the right to appear in proper person or by or with counsel.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, the respondent shall be represented only by an attorney who has been admitted to the Maryland Bar or specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14.</text> </paragraph> <paragraph num="C."> <text>The administrative prosecutor assigned to a disciplinary matter by the Office of the Attorney General shall prosecute the disciplinary matter in Board proceedings.</text> </paragraph> <paragraph num="D."> <text>In all proceedings, the Board shall be represented by and obtain advice from counsel assigned to it by the Office of the Attorney General.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Filing of Complaints."> <paragraph num="A."> <text>The Board may commence proceedings or open an investigation under Health Occupations Article, §4-315, Annotated Code of Maryland, after the filing of a complaint:</text> <paragraph num="(1)"> <text>Received from an individual who is not a member of the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Completed by the Board on its own initiative and signed by a member of the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a person who is not a member of the Board files a complaint, the complaint shall:</text> <paragraph num="(1)"> <text>Be completed on a Board-approved form;</text> </paragraph> <paragraph num="(2)"> <text>Be in writing;</text> </paragraph> <paragraph num="(3)"> <text>Allege facts such that the Board may determine whether the facts may constitute violations of the Maryland Dentistry Act or the regulations adopted by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Contain a Release of Medical Records and a Release of Additional Information;</text> </paragraph> <paragraph num="(5)"> <text>Contain an affidavit indicating that the matters set forth in the complaint are true to the best of the knowledge, information, and belief of the complainant; and</text> </paragraph> <paragraph num="(6)"> <text>Be signed by the complainant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may accept a complaint for filing that substantially fulfills the requirements of this regulation.</text> </paragraph> <paragraph num="D."> <text>Absent extenuating circumstances, the Board shall send a letter to the complainant or the complainant’s representative acknowledging receipt of the complaint within 45 days of its filing.</text> </paragraph> <paragraph num="E."> <text>The letter referred to in §D of this regulation shall:</text> <paragraph num="(1)"> <text>Contain a brief explanation of the Board’s complaint process; and</text> </paragraph> <paragraph num="(2)"> <text>Advise the complainant that the complaint may ultimately:</text> <paragraph num="(a)"> <text>Be dismissed;</text> </paragraph> <paragraph num="(b)"> <text>Be referred to a Peer Review Committee;</text> </paragraph> <paragraph num="(c)"> <text>Result in an informal action; or</text> </paragraph> <paragraph num="(d)"> <text>Result in a final order.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Board may not bring disciplinary charges against a respondent based solely on events contained in a complaint the Board receives more than 6 years after:</text> <paragraph num="(1)"> <text>The day the complainant actually discovered the facts that form the basis of the complaint; or</text> </paragraph> <paragraph num="(2)"> <text>The day when a reasonable person exercising due diligence should have discovered the facts that form the basis of the complaint.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The provisions of §F of this regulation may not apply to a complaint based on:</text> <paragraph num="(1)"> <text>Criminal convictions or sexual misconduct or other similar boundary violations;</text> </paragraph> <paragraph num="(2)"> <text>Reciprocal disciplinary matters;</text> </paragraph> <paragraph num="(3)"> <text>Ongoing substance abuse;</text> </paragraph> <paragraph num="(4)"> <text>Fraudulent concealment of material information; or</text> </paragraph> <paragraph num="(5)"> <text>Acts that occur while a patient is a minor.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Board shall log in and assign a case number to complaints that meet the requirements of this chapter.</text> </paragraph> <paragraph num="I."> <text>Complaints that do not meet the requirements of this chapter shall be returned to the complainant with a brief explanation of why the complaint was returned.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disposition of Complaint."> <paragraph num="A."> <text>Complaints shall be referred to the Board’s Triage Committee.</text> </paragraph> <paragraph num="B."> <text>To the extent practicable, filed complaints shall be presented to the Board’s Triage Committee within 60 days of their receipt.</text> </paragraph> <paragraph num="C."> <text>To the extent practicable, the Board’s staff shall remove the respondent’s name and address from complaint before the documents are reviewed by the Triage Committee.</text> </paragraph> <paragraph num="D."> <text>The name and address of the respondent shall appear on documents that are referred from the:</text> <paragraph num="(1)"> <text>Triage Committee to the Discipline Review Committee; or</text> </paragraph> <paragraph num="(2)"> <text>Discipline Review Committee to the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>After review of the complaint, the Triage Committee shall make recommendations to the Board’s Discipline Review Committee (DRC).</text> </paragraph> <paragraph num="F."> <text>The Triage Committee may make the following recommendations to the DRC:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(3)"> <text>Issue an advisory letter or letter of education;</text> </paragraph> <paragraph num="(4)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(5)"> <text>Mail or deliver to the respondent a request for:</text> <paragraph num="(a)"> <text>A response to the complaint and a request for patient records;</text> </paragraph> <paragraph num="(b)"> <text>A response to the complaint only; or</text> </paragraph> <paragraph num="(c)"> <text>Patient records only;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Refer the case to peer review for mediation;</text> </paragraph> <paragraph num="(7)"> <text>Refer the matter to the:</text> <paragraph num="(a)"> <text>Dental Well-Being Committee; or</text> </paragraph> <paragraph num="(b)"> <text>Dental Hygiene Well-Being Committee;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Refer the matter to another governmental agency or other regulatory agency;</text> </paragraph> <paragraph num="(9)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(10)"> <text>Refer the matter to an administrative prosecutor;</text> </paragraph> <paragraph num="(11)"> <text>Request any other information or documentation from any person that the committee deems relevant to the disposition of the complaint; or</text> </paragraph> <paragraph num="(12)"> <text>Any other recommendation that the Triage Committee may make to the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Participation in the Triage Committee is not a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in a case.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Discipline Review Committee (DRC)."> <paragraph num="A."> <text>The DRC shall:</text> <paragraph num="(1)"> <text>Consider and vote on the recommendations of the Triage Committee;</text> </paragraph> <paragraph num="(2)"> <text>Review documents received by the Board during the course of the Board’s investigations; and</text> </paragraph> <paragraph num="(3)"> <text>Make recommendations to the Board for the disposition of the complaint for the Board’s vote.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When considering the recommendations of the Triage Committee, the DRC may vote to:</text> <paragraph num="(1)"> <text>Accept all of the recommendations of the Triage Committee;</text> </paragraph> <paragraph num="(2)"> <text>Accept some of the recommendations of the Triage Committee;</text> </paragraph> <paragraph num="(3)"> <text>Accept none of the recommendations of the Triage Committee; or</text> </paragraph> <paragraph num="(4)"> <text>Make any other recommendations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After receiving recommendations from the Triage Committee, the DRC, without Board approval, may vote to:</text> <paragraph num="(1)"> <text>Mail or deliver to the respondent a request for:</text> <paragraph num="(a)"> <text>A response to the complaint and a request for patient records;</text> </paragraph> <paragraph num="(b)"> <text>A response to the complaint only; or</text> </paragraph> <paragraph num="(c)"> <text>Patient records only;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mail or deliver to any person a request for information; or</text> </paragraph> <paragraph num="(3)"> <text>Refer the matter for further investigation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Complaints may be referred directly to the DRC without prior review by the Triage Committee.</text> </paragraph> <paragraph num="E."> <text>The DRC may make the following recommendations to the Board:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Place the case on administrative hold;</text> </paragraph> <paragraph num="(3)"> <text>Close the case;</text> </paragraph> <paragraph num="(4)"> <text>Issue an advisory letter or letter of education;</text> </paragraph> <paragraph num="(5)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(6)"> <text>Refer the case to peer review for mediation;</text> </paragraph> <paragraph num="(7)"> <text>Mail or deliver to the respondent a request for:</text> <paragraph num="(a)"> <text>A response to the complaint and a request for patient records;</text> </paragraph> <paragraph num="(b)"> <text>A response to the complaint only; or</text> </paragraph> <paragraph num="(c)"> <text>Patient records only;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Mail or deliver to any person a request for information;</text> </paragraph> <paragraph num="(9)"> <text>Refer the matter to the:</text> <paragraph num="(a)"> <text>Dental Well-Being Committee; or</text> </paragraph> <paragraph num="(b)"> <text>Dental Hygiene Well-Being Committee;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(11)"> <text>Refer the matter to an administrative prosecutor;</text> </paragraph> <paragraph num="(12)"> <text>Request other information or documentation from any person that the committee deems relevant to the disposition of the complaint; or</text> </paragraph> <paragraph num="(13)"> <text>Any other recommendation that the DRC may make to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Board Review of Complaints."> <paragraph num="A."> <text>For each complaint, after reviewing any completed investigative information or reports and considering the recommendation of the Triage Committee or Discipline Review Committee, if applicable, the Board shall:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Place the case on administrative hold;</text> </paragraph> <paragraph num="(3)"> <text>Close the case;</text> </paragraph> <paragraph num="(4)"> <text>Refer the case to peer review for mediation;</text> </paragraph> <paragraph num="(5)"> <text>Refer the matter to the:</text> <paragraph num="(a)"> <text>Dental Well-Being Committee;</text> </paragraph> <paragraph num="(b)"> <text>Dental Hygiene Well-Being Committee;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(7)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(8)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(9)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(10)"> <text>Vote to:</text> <paragraph num="(a)"> <text>Charge a licensee with a violation of Health Occupations Article, §4-315, Annotated Code of Maryland, or the regulations adopted by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Initially deny:</text> <paragraph num="(i)"> <text>Licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(ii)"> <text>Certification or reinstatement of a certificate;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board; or</text> </paragraph> <paragraph num="(e)"> <text>Take any other action the Board is authorized to take.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether it has voted to charge a licensee with violations of the Maryland Dentistry Act or the regulations adopted by the Board.</text> </paragraph> <paragraph num="C."> <text>If the Board investigates a complaint, the Board shall mail a copy of the complaint to the respondent unless:</text> <paragraph num="(1)"> <text>The complaint alleges facts which may constitute fraud or dishonesty; or</text> </paragraph> <paragraph num="(2)"> <text>Disclosing the complaint may prejudice the investigation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Absent exigent circumstances, the Board shall grant a person at least 10 calendar days to:</text> <paragraph num="(1)"> <text>Provide the Board with requested documents; or</text> </paragraph> <paragraph num="(2)"> <text>File a written response to a request for information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board investigations are warranted when there is evidence that the respondent or other person may have violated the Maryland Dentistry Act or the regulations adopted by the Board.</text> </paragraph> <paragraph num="F."> <text>A matter that may serve as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, may be referred directly to:</text> <paragraph num="(1)"> <text>The DRC;</text> </paragraph> <paragraph num="(2)"> <text>The Board; or</text> </paragraph> <paragraph num="(3)"> <text>The Administrative Prosecutor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Investigation of Complaints."> <paragraph num="A."> <text>The Board's DRC shall:</text> <paragraph num="(1)"> <text>Review complaints; and</text> </paragraph> <paragraph num="(2)"> <text>Make a recommendation to the Board as to the disposition of the complaint.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Participation in the Disciplinary Review Committee is not a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in a complaint.</text> </paragraph> <paragraph num="C."> <text>If the Board votes to refer a matter to an investigator, to the extent practicable, the complaint shall be assigned to an investigator within 3 business days of the Board’s vote.</text> </paragraph> <paragraph num="D."> <text>An investigator shall provide periodic reports to the complainant or the complainant’s representative within the bounds of the Maryland Public Information Act or other applicable laws.</text> </paragraph> <paragraph num="E."> <text>To the extent practicable, an investigator shall strive to complete an initial investigative report within 180 days after a complaint is assigned.</text> </paragraph> <paragraph num="F."> <text>Factors that affect the length of time to complete an initial investigative report include but are not limited to:</text> <paragraph num="(1)"> <text>The number of alleged violations included in the complaint;</text> </paragraph> <paragraph num="(2)"> <text>The severity of the allegations in the complaint;</text> </paragraph> <paragraph num="(3)"> <text>The number of additional violations that arise as a result of the investigation of the complaint;</text> </paragraph> <paragraph num="(4)"> <text>The complexity of the legal issues encountered during the investigation;</text> </paragraph> <paragraph num="(5)"> <text>The cooperation or lack thereof of the respondent, counsel, and witnesses;</text> </paragraph> <paragraph num="(6)"> <text>The availability of the investigator;</text> </paragraph> <paragraph num="(7)"> <text>Other investigative priorities;</text> </paragraph> <paragraph num="(8)"> <text>The necessity and availability of additional required documents or findings from other agencies or authorities including but not limited to:</text> <paragraph num="(a)"> <text>Other governmental agencies or other regulatory agencies;</text> </paragraph> <paragraph num="(b)"> <text>Hospitals;</text> </paragraph> <paragraph num="(c)"> <text>The courts; and</text> </paragraph> <paragraph num="(d)"> <text>Law enforcement agencies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An initial investigative report shall be presented to the Board within 90 days of its completion.</text> </paragraph> <paragraph num="H."> <text>The failure to meet the goal of completing an initial investigative report within 180 days or the presentation to the Board of an initial investigative report within 90 days of its completion may not:</text> <paragraph num="(1)"> <text>Be raised as a defense by a respondent; and</text> </paragraph> <paragraph num="(2)"> <text>Be admissible by the respondent in any civil or administrative proceeding.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An initial investigative report may also be a final investigative report.</text> </paragraph> <paragraph num="J."> <text>The Board shall advise the complainant or the complainant’s representative of the final disposition of a complaint within the bounds of the Maryland Public Information Act or other applicable laws.</text> </paragraph> <paragraph num="K."> <text>To the extent practicable, the Board shall mail copies of final orders to the respondent or to the respondent’s counsel within 15 days.</text> </paragraph> <paragraph num="L."> <text>If a complaint results in a final order against a respondent that is a public document under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland, the Board shall mail a copy of the final order to the complainant or the complainant’s representative within 15 days.</text> </paragraph> <paragraph num="M."> <text>At the conclusion of a case the Board shall make reasonable efforts to return original medical records in its possession to the appropriate health care provider within 45 days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Charges and Notice of Initial Denial."> <paragraph num="A."> <text>If the Board issues charges or a notice of initial denial, the Executive Director or an officer of the Board shall hand deliver or send the charges or notice of initial denial to the respondent's last known business and home addresses by certified mail.</text> </paragraph> <paragraph num="B."> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(1)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(2)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(a)"> <text>Violation of the Maryland Dentistry Act; or</text> </paragraph> <paragraph num="(b)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Notify the respondent of:</text> <paragraph num="(a)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(b)"> <text>The consequences of failing to appear for those proceedings or of failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §A of this regulation, the Board nevertheless may proceed in prosecuting the case.</text> </paragraph> <paragraph num="D."> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Discovery."> <paragraph num="A."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may request another party to produce, within 15 calendar days, the following:</text> <paragraph num="(1)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §A(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness that will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the testimony of the expert, and any report of the expert, shall be excluded from the hearing.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Parties are not entitled to discovery of items other than those listed in §§A and B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="E."> <text>Absent unforeseen circumstances which would impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(1)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>If no prehearing conference is scheduled, 15 days before the hearing.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The prohibition against adding witnesses or documents does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="G."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Case Resolution Conference."> <paragraph num="A."> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="B."> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter. The Board may grant or deny the respondent's request.</text> </paragraph> <paragraph num="C."> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="D."> <text>The recommendations of the case resolution conference committee are not binding on the Board, which may:</text> <paragraph num="(1)"> <text>Accept a proposed settlement;</text> </paragraph> <paragraph num="(2)"> <text>Modify a proposed settlement; or</text> </paragraph> <paragraph num="(3)"> <text>Reject the proposed settlement and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement, the case resolution conference committee may offer a proposed settlement agreement to the parties.</text> </paragraph> <paragraph num="F."> <text>If either the respondent or administrative prosecutor disagrees with the recommendation of the case resolution conference committee, either party may elect to proceed to a hearing in the matter regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="G."> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Prehearing Conference."> <paragraph num="A."> <text>Prehearing Conference. The Board may set a prehearing conference upon motion of either party, or on the Board's own motion.</text> </paragraph> <paragraph num="B."> <text>The prehearing conference may be used to:</text> <paragraph num="(1)"> <text>Attempt to settle the case; or</text> </paragraph> <paragraph num="(2)"> <text>Prepare for hearing by:</text> <paragraph num="(a)"> <text>Delineating the issues;</text> </paragraph> <paragraph num="(b)"> <text>Stipulating to the facts, laws, and other matters;</text> </paragraph> <paragraph num="(c)"> <text>Arranging a schedule; and</text> </paragraph> <paragraph num="(d)"> <text>Arranging for the submission of names of witnesses to be called and the subject matter of testimony to be presented in the hearing; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Accomplish any other purpose the Board considers necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Motions."> <paragraph num="A."> <text>A motion shall be accompanied by a memorandum of points and authorities and shall be filed with the Board at least 15 days before the hearing. A copy shall be served on the opposing party.</text> </paragraph> <paragraph num="B."> <text>A response shall be filed with the Board at least 7 days before the hearing and a copy served on the opposing party.</text> </paragraph> <paragraph num="C."> <text>The Board may consider a motion on the day of the hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Hearings on Charges or Notice of Initial Denial."> <paragraph num="A."> <text>Hearings shall be conducted under the contested case provision of State Government Article, Title 10, Subtitle 2 and Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>Proceedings are closed to the public and all records, including the recommended decision, are confidential and shall be sealed except as otherwise provided in a final Board order or as provided by law.</text> </paragraph> <paragraph num="D."> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of them under the Board's delegation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Burden of Proof."> <paragraph num="A."> <text>A licensee against whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has denied.</text> </paragraph> <paragraph num="B."> <text>The State has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Dentistry Act or of the rules and regulations promulgated under the Act.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Exceptions."> <paragraph num="A."> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, each party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise permitted by the Board, or as otherwise specified by the administrative law judge in the recommended decision, either party shall file written exceptions with the Board within 15 days after the issuance of the recommended decision.</text> </paragraph> <paragraph num="C."> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages and shall state with particularity:</text> <paragraph num="(1)"> <text>The finding of fact, conclusion of law, or other matter excepted to; and</text> </paragraph> <paragraph num="(2)"> <text>The relevant portions of the record supporting the party's exception.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Unless otherwise permitted by the Board, within 15 days after a party's exceptions are filed with the Board, the opposing party may file a response to the exceptions.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise permitted by the Board, a party's response to the exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="F."> <text>Unless otherwise permitted, the Board may not consider a party's reply to a response to exceptions.</text> </paragraph> <paragraph num="G."> <text>Unless otherwise agreed to by the parties and permitted by the Board, an exceptions hearing shall be scheduled within 30 days after receipt of the parties' exceptions and any response to exceptions, and on a day on which the Board regularly meets.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Exceptions Hearing."> <paragraph num="A."> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="B."> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and response to exceptions.</text> </paragraph> <paragraph num="C."> <text>The Board member presiding over the hearing shall determine all procedural issues and shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="D."> <text>The respondent and the administrative prosecutor ordinarily shall be limited to 30 minutes each in which to present oral argument.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in any response to exceptions, or in the hearing on exceptions, reference any document or other evidence or offer any exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="F."> <text>If neither party files exceptions within the time specified in Regulation .14 of this chapter, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctioning Guidelines."> <text>The Board shall consider the sanctioning guidelines contained in COMAR 10.44.31 before issuing a final order and before taking informal disciplinary action.</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Board Final Decision and Order."> <paragraph num="A."> <text>After review of the record and deliberation, the Board shall issue a final order of either:</text> <paragraph num="(1)"> <text>Dismissal;</text> </paragraph> <paragraph num="(2)"> <text>Revocation;</text> </paragraph> <paragraph num="(3)"> <text>Suspension;</text> </paragraph> <paragraph num="(4)"> <text>Denial of licensure;</text> </paragraph> <paragraph num="(5)"> <text>Reprimand;</text> </paragraph> <paragraph num="(6)"> <text>Probation;</text> </paragraph> <paragraph num="(7)"> <text>Civil penalty; or</text> </paragraph> <paragraph num="(8)"> <text>Other disposition as appropriate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Within 15 days after the Board issues a final order, either party may file a motion for reconsideration with the Board, which the Board may grant.</text> </paragraph> <paragraph num="C."> <text>There is no right to a hearing on a party's motion for reconsideration, and the Board may request a response to the motion from the opposing party.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Surrender of License."> <paragraph num="A."> <text>The Board may require conditions for surrender of a license, including, but not limited to:</text> <paragraph num="(1)"> <text>The admission of a violation of the Maryland Dentistry Act;</text> </paragraph> <paragraph num="(2)"> <text>The admission of facts;</text> </paragraph> <paragraph num="(3)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(4)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(5)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(6)"> <text>An agreement that the respondent may not apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A letter of surrender is a final order of the Board and is a public document under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board shall vote to issue a notice of intent to summarily suspend a license.</text> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license, the Board shall refer the matter to the administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include, but is not limited to:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and which includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license:</text> <paragraph num="(i)"> <text>At least 5 calendar days before a predeprivation show cause hearing is scheduled before the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>By hand delivery by the Executive Director or an officer of the Board to the address the respondent is required to maintain with the Board, or by any other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Predeprivation Opportunity to Be Heard."> <paragraph num="A."> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="B."> <text>A Predeprivation Show Cause Hearing before the Board.</text> <paragraph num="(1)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>The Board member presiding over the hearing shall determine all procedural issues and shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(3)"> <text>The respondent and the administrative prosecutor ordinarily shall be limited to 30 minutes each in which to present oral argument.</text> </paragraph> <paragraph num="(4)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board member who presides over the hearing:</text> <paragraph num="(1)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious if the presiding Board member believes that the documents or exhibits are necessary in order for a fair hearing; and</text> </paragraph> <paragraph num="(2)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Summary Suspension Without Prior Notice or Opportunity for Hearing."> <paragraph num="A."> <text>In extraordinary circumstances, the Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend license or providing a respondent with an opportunity for a predeprivation hearing if:</text> <paragraph num="(1)"> <text>The Board determines that the public health, safety, and welfare require the immediate suspension of the license without prior notice and an opportunity to be heard; and</text> </paragraph> <paragraph num="(2)"> <text>The respondent is provided with an opportunity for a hearing before the Board at the Board's next regularly scheduled meeting but not to exceed 30 days from the date of respondent's request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board votes to issue an order of summary suspension, the Board shall refer the matter to the administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="C."> <text>An order of summary suspension of a license shall include, but is not limited to:</text> <paragraph num="(1)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(2)"> <text>Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare;</text> </paragraph> <paragraph num="(3)"> <text>Notice to the respondent of the right to request a postdeprivation show cause hearing to provide the respondent with the opportunity to show cause why the order of summary suspension should not continue and which notifies the respondent of the consequences of failing to appear; and</text> </paragraph> <paragraph num="(4)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension</text> </paragraph> </paragraph> <paragraph num="D."> <text>Service.</text> <paragraph num="(1)"> <text>The Board shall serve a respondent with the order of summary suspension by having the Executive Director or an officer of the Board hand deliver the order to the address the respondent is required to maintain with the Board within 24 hours after its execution; or</text> </paragraph> <paragraph num="(2)"> <text>By any other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the respondent requests a hearing under §C(3) of this regulation, the Board shall conduct the hearing as provided in Regulation .19B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Burdens of Production and Persuasion."> <paragraph num="A."> <text>In a show cause proceeding under Regulation .19B of this chapter, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="B."> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Disposition."> <paragraph num="A."> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, after the show cause hearing, it may vote to:</text> <paragraph num="(1)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(4)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board orders a summary suspension before a show cause hearing, at the conclusion of the hearing, the Board may vote to:</text> <paragraph num="(1)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter into an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(4)"> <text>Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings are final orders of the Board and public documents under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Postdeprivation Opportunity for an Evidentiary Hearing."> <paragraph num="A."> <text>If the Board orders the summary suspension of a license under Regulation .19 of this chapter, the respondent shall be provided with the opportunity for an appeal. The appeal from a summary suspension shall be an evidentiary hearing under the Administrative Procedure Act.</text> </paragraph> <paragraph num="B."> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="C."> <text>Unless otherwise agreed by the parties, the Board shall provide a hearing within 45 days after the respondent's request.</text> </paragraph> <paragraph num="D."> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension.</text> </paragraph> <paragraph num="E."> <text>The Board shall conduct an evidentiary hearing under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="F."> <text>If the Board has delegated the matter to the Office of Administrative Hearings, the administrative law judge shall issue to the Board a recommended decision with proposed findings of fact, proposed conclusions of law, and a proposed disposition, or any combination of these under the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="G."> <text>If the hearing is one combined with charges, the administrative law judge's determination as to the merits of the summary suspension shall be based only on those parts of the record that were available to the Board at the time it voted for the summary suspension.</text> </paragraph> <paragraph num="H."> <text>The parties may file exceptions to the recommended decision as provided in the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="I."> <text>An order issued by the Board after a postdeprivation evidentiary hearing is a final order of the Board and is a public document under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which it considers appropriate, including:</text> <paragraph num="(1)"> <text>Re-education or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a civil penalty or donation to an approved institution providing dental services for the poor, indigent, or handicapped;</text> </paragraph> <paragraph num="(3)"> <text>Provision of free dental services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Entrance into and compliance with a contract with the Dental Well-Being Committee or Dental Hygiene Well-Being Committee;</text> </paragraph> <paragraph num="(5)"> <text>Practice supervision;</text> </paragraph> <paragraph num="(6)"> <text>Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board;</text> </paragraph> <paragraph num="(7)"> <text>Periodic review of a licensee's clinical practice;</text> </paragraph> <paragraph num="(8)"> <text>Periodic review of a licensee's billing practices;</text> </paragraph> <paragraph num="(9)"> <text>Periodic audits of a licensee's billing practices;</text> </paragraph> <paragraph num="(10)"> <text>An examination by a physician or appropriate health care provider;</text> </paragraph> <paragraph num="(11)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(12)"> <text>A passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(13)"> <text>Any other condition the Board considers appropriate for the rehabilitation or re-training of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board for termination of probation when the specific period of time has passed or when the licensee has successfully completed the conditions or acts required for termination, as provided in the Board's order.</text> </paragraph> <paragraph num="D."> <text>If at any time the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action provided for in the final order or consent order if there is a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and which the Board may take.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Charges for Violation of Probation."> <paragraph num="A."> <text>If the Board issues charges for a violation of probation, the service shall be as provided in Regulation .07A of this chapter.</text> </paragraph> <paragraph num="B."> <text>The charging document for a violation of probation shall:</text> <paragraph num="(1)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order that the Board believes has been violated;</text> </paragraph> <paragraph num="(2)"> <text>Allege facts that the Board believes constitute either a basis for a violation of probation; and</text> </paragraph> <paragraph num="(3)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or failing to request a hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board, before the hearing, shall provide the respondent with a case resolution conference to discuss settlement of the matter. The case resolution conference shall be conducted as provided in Regulation .09 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Violation of Probation Hearing."> <paragraph num="A."> <text>The hearing shall be an evidentiary hearing held in the manner set forth in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The burden of proof shall be as set forth in Regulation .13 of this chapter.</text> </paragraph> <paragraph num="C."> <text>After a hearing, the Board shall issue a final order consisting of findings of fact, conclusions of law, and an order. The order shall be a final order of the Board.</text> </paragraph> <paragraph num="D."> <text>If the Board determines that a respondent has violated probation, the Board may:</text> <paragraph num="(1)"> <text>Take any action provided for in the consent order or final order in the event of a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose any sanction or take any other action that the Board considers appropriate and may take.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Reinstatement of a License."> <paragraph num="A."> <text>Petition for Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for reinstatement after suspension, revocation, or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>Subject to contrary provisions in a final order of revocation or a surrender, the Board may not consider a petition for reinstatement after the revocation of a license or a surrender until 3 years after the effective date of the revocation or surrender.</text> </paragraph> <paragraph num="(3)"> <text>A licensee who petitions the Board for reinstatement under terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board, shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(4)"> <text>A licensee whose license has been revoked or surrendered for 3 or more years before filing a petition for reinstatement is not eligible for reinstatement but instead shall apply for initial licensure.</text> </paragraph> <paragraph num="(5)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement set out in COMAR 10.44.10; and</text> </paragraph> <paragraph num="(c)"> <text>Achieve a passing score on the Board's law examination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Opportunity for a Hearing.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, the Board shall serve the notice as provided in Regulation .07A of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the Board's legal basis for its belief that the applicant is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts which the Board believes supports the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board, before the hearing, shall provide the applicant with a case resolution conference to discuss settlement of the matter. The case resolution conference shall be conducted as provided in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or delegated to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, the Board may impose any restrictions or conditions on the license or the licensee's practice that the Board considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §4-319, and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".33" heading="Imposition of Penalties."> <text>The Board may impose a civil monetary penalty instead of or in addition to a disciplinary sanction authorized by Health Occupations Article, §4-315, Annotated Code of Maryland, and as provided in COMAR 10.44.08.</text> </regulation> <regulation prefix="Regulation" num=".34" heading="Recusal in Board Proceedings."> <paragraph num="A."> <text>A Board member or the Dental Compliance Officer may not participate in an investigation or a proceeding in which the impartiality of the Board member or Dental Compliance Officer might reasonably be questioned, including, but not limited to those investigations or proceedings in which the Board member or Dental Compliance Officer has or appears to have:</text> <paragraph num="(1)"> <text>A personal bias or prejudice concerning a party; or</text> </paragraph> <paragraph num="(2)"> <text>Personal knowledge of disputed evidentiary facts obtained outside the administrative or disciplinary process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Participation by a Board member or Dental Compliance Officer in an investigation, disciplinary review committee, case resolution conference, or other administrative proceeding involving a respondent or applicant is not a basis for recusal in a contested case unless the Board member or Dental Compliance Officer has:</text> <paragraph num="(1)"> <text>A personal bias or prejudice concerning a party; or</text> </paragraph> <paragraph num="(2)"> <text>Personal knowledge of disputed evidentiary facts obtained outside the administrative or disciplinary process.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A Board member or the Dental Compliance Officer may make a voluntary determination to recuse oneself from further proceedings in a case.</text> </paragraph> <paragraph num="D."> <text>A respondent who seeks recusal of one or more Board members shall name the Board member or members the respondent seeks to have recused and state with specificity on the record the reasons why the Board member or members should be recused. The Board may deliberate on the issue of recusal of the Board member or Board members and shall state its finding on the record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Consideration and Notice of Board Files."> <text>In any matter governed by this chapter, the Board may take official notice of any information contained in the Board's files.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-603, 4-205, 4-316, and 4-318, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 adopted as an emergency provision effective September 29, 1980 (7:21 Md. R. 1989); emergency status expired February 14, 1981; adopted permanently effective March 6, 1981 (8:5 Md. R. 475)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective November 20, 1994 (21:23 Md. R. 1933)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01 — .31 adopted effective March 1, 2004 (31:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">chapter revised effective March 5, 2012 (39:4 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 8, 2016 (43:24 Md. R. 1350)</annotation> </annotations> </chapter> <chapter num="08" heading="Civil Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish the standards by which the Board may impose a civil penalty of not more than $5,000 against any dentist licensed in the State who is found to be in violation of Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Civil penalty” means a monetary penalty.</text> </paragraph> <paragraph num="(3)"> <text>“Universal precautions” means blood and body fluid precautions as defined in “Control of Communicable Diseases in Man”, which is incorporated by reference in COMAR 10.06.01.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Civil Penalty."> <text>After a hearing as provided in COMAR 10.44.07, the Board may impose a civil penalty against a dentist for violation of Health Occupations Article, §4-315, and pertinent regulations:</text> <paragraph num="A."> <text>In place of, or in addition to, suspension of a dentist's license; or</text> </paragraph> <paragraph num="B."> <text>In addition to the revocation of a dentist's license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Violations for Which Civil Penalties May Be Imposed."> <text>Civil penalties may be imposed if a dentist is found to have violated any section of Health Occupations Article, §4-315(a), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Guidelines for Imposing Civil Penalties."> <text>The Board may impose a penalty for violations of Regulation .04 of this chapter considering the nature and severity of the violation consistent with the following guidelines:</text> <paragraph num="A."> <text>For the first violation, a civil penalty of not more than 25 percent of the maximum civil penalty;</text> </paragraph> <paragraph num="B."> <text>For the second violation, a civil penalty of not more than 50 percent of the maximum civil penalty;</text> </paragraph> <paragraph num="C."> <text>For the third and any subsequent violation, a civil penalty of not more than the maximum civil penalty.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Power and Authority of Board."> <text>The power and authority of the Board to impose these civil penalties may not be affected or diminished by any other proceeding, civil or criminal, concerning the same violation or violations except as provided in these regulations.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Appeal Rights."> <text>A licensee against whom a civil penalty has been imposed may have judicial review of the Board's decision as provided by law.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Payment of Penalties."> <paragraph num="A."> <text>A civil penalty imposed under these regulations shall be paid to the Board by the licensee upon the expiration of the period allowed for appeal. Noting of an appeal does not stay the Board's order. Money collected by the Board under these regulations shall be paid over to the State Treasurer and shall become part of the General Fund of the State.</text> </paragraph> <paragraph num="B."> <text>When payment of a civil penalty imposed by the Board against a license in accordance with these regulations is not paid by the licensee when due under these regulations, the Board shall refer the case to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings for enforcement of payment.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-205(b)(3) and 4-317, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 23, 1981 (8:23 Md. R. 1857)</annotation> <annotation type="History" subtype="Administrative History">(Originally promulgated as COMAR 10.44.09. Recodified to 10.44.08)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 19, 1990 (17:3 Md. R. 300); June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 19, 1990 (17:3 Md. R. 300); June 15, 1998 (25:12 Md. R. 947)</annotation> </annotations> </chapter> <chapter num="09" heading="Licensure for Dental Hygienists Licensed in Another State"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ADEX” means the American Board of Dental Examiners, Inc., or its successor organization.</text> </paragraph> <paragraph num="(2)"> <text>“ADHLEX” means the American Dental Hygiene Licensing Examination, which includes both a written component and a clinic component, designed and developed by ADEX, or its successor examination.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifications for All Applicants."> <text>A dental hygienist holding an active license in any other state may be granted a license in Maryland if the applicant:</text> <paragraph num="A."> <text>Meets the requirements of Health Occupations Article, §4-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Is of good moral character;</text> </paragraph> <paragraph num="C."> <text>Is a graduate of a school for dental hygienists that:</text> <paragraph num="(1)"> <text>Requires at least 2 years of education in an institution of higher education;</text> </paragraph> <paragraph num="(2)"> <text>Is accredited by the American Dental Association Commission on Dental Accreditation; and</text> </paragraph> <paragraph num="(3)"> <text>Is approved by the Board; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Meets the qualifications otherwise required by Health Occupations Article, Title 4, Annotated Code of Maryland, for an active general license to practice dental hygiene.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure of Dental Hygienists Who Have Passed the ADHLEX Examination."> <paragraph num="A."> <text>In addition to meeting the requirements of Regulation .02 of this chapter, a dental hygienist holding an active license in any other state shall be issued a license if the applicant:</text> <paragraph num="(1)"> <text>Has passed the ADHLEX with a score of 75 or greater in each required section; and</text> </paragraph> <paragraph num="(2)"> <text>Has passed the Maryland Dental Hygiene Jurisprudence Examination given by the Board or its designee with a minimum score of 75 or greater on each section of the examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, a candidate holding an active license in another state, or who has ever held an active license in another state, shall provide adequate evidence satisfactory to the Board that the candidate:</text> <paragraph num="(1)"> <text>Is not being investigated by a disciplinary authority of another state:</text> </paragraph> <paragraph num="(2)"> <text>Does not have charges pending against the applicant’s license;</text> </paragraph> <paragraph num="(3)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(4)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure of Dental Hygienists Who Have Not Passed the ADHLEX Examination."> <paragraph num="A."> <text>In addition to meeting the requirements of Regulation .02 of this chapter, a dental hygienist holding an active license in another state who has not passed the ADHLEX examination with a score of 75 or greater in each required section of the ADHLEX shall be issued a license if the applicant:</text> <paragraph num="(1)"> <text>For the 3 preceding years has been actively engaged in practicing dental hygiene for at least 150 hours on average per year;</text> </paragraph> <paragraph num="(2)"> <text>Has passed an examination with a clinical component as a requirement for licensure in another state;</text> </paragraph> <paragraph num="(3)"> <text>Has passed a comprehensive written examination on applied clinical diagnosis and treatment planning administered by ADEX with a score of 75 or greater in each required section; and</text> </paragraph> <paragraph num="(4)"> <text>Has passed the Maryland Dental Hygiene Jurisprudence Examination given by the Board or its designee with a score of 75 or greater on each section of the examination.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The practice of dental hygiene in the armed forces, the practice of dental hygiene in state and federal programs, participation in post-graduate intern programs, or participation in residency programs within the 5 years preceding application counts toward the required hours of active practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedures."> <paragraph num="A."> <text>An applicant who has passed the ADHLEX with a score of 75 or greater in each required section shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="(4)"> <text>Certified proof of dental hygiene education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature, do not require a raised embossed seal;</text> </paragraph> <paragraph num="(5)"> <text>A certified examination score of the ADHLEX and, if requested by the Board, a specific point breakdown by procedure including penalty deductions if available;</text> </paragraph> <paragraph num="(6)"> <text>A certified letter with a raised embossed seal from the dental hygiene licensing authority of each state in which the applicant holds an active dental hygiene license or ever held an active dental hygiene license indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(8)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who has not passed the ADHLEX shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="(4)"> <text>Certified proof of dental hygiene education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature, do not require a raised embossed seal;</text> </paragraph> <paragraph num="(5)"> <text>A certified letter with a raised embossed seal from the dental hygiene licensing authority of each state in which the applicant holds an active dental hygiene license or ever held an active dental hygiene license indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A notarized affidavit or other evidence satisfactory to the Board indicating that for the 3 preceding years the applicant has been actively engaged in practicing dental hygiene for at least 150 hours on average per year;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(8)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fees."> <paragraph num="A."> <text>The application fee shall accompany the application and is specified in COMAR 10.44.20.</text> </paragraph> <paragraph num="B."> <text>The application fee is nonrefundable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-303.1(d) and 4-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 1, 1983 (10:15 Md. R. 1351)</annotation> <annotation type="History" subtype="Administrative History">Recodified from COMAR 10.44.12 to 10.44.09</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 recodified to Regulation .01-1 and the Preface recodified to Regulation .01 in November 1990</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective September 3, 1990 (17:17 Md. R. 2081); April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 19, 1999 (26:8 Md. R. 615); December 23, 2002 (29:25 Md. R. 1984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective September 3, 1990 (17:17 Md. R. 2081)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C repealed effective December 23, 2002 (29:25 Md. R. 1984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 3, 1990 (17:17 Md. R. 2081); April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C adopted effective September 3, 1990 (17:17 Md. R. 2081)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective April 19, 1999 (26:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed and new Regulations .01 — .05 adopted effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 24, 2005 (32:21 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 24, 2005 (32:21 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 repealed and new Regulations .01 — .06 adopted as an emergency provision effective October 1, 2012 (39:22 Md. R. 1426); adopted permanently effective December 24, 2012 (39:25 Md. R. 1613)</annotation> </annotations> </chapter> <chapter num="10" heading="Renewal and Reinstatement of Licenses"> <regulation prefix="Regulation" num=".01" heading="Expiration Date of Licenses."> <paragraph num="A."> <text>A general license to practice dentistry and a general license to practice dental hygiene shall expire on June 30 of the second year following the effective date of the license.</text> </paragraph> <paragraph num="B."> <text>A limited license to practice dentistry shall expire 1 year from its effective date and must be reapplied for.</text> </paragraph> <paragraph num="C."> <text>A teacher's license to practice dentistry and a teacher's license to practice dental hygiene shall expire in the same manner as the general license, or when the licensee ceases teaching at the institution named on the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Renewal of Licenses."> <paragraph num="A."> <text>Before a general license to practice dentistry expires, the licensee may renew it for an additional term, if the licensee:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee specified in COMAR 10.44.20;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a renewal application on the form that the Board provides; and</text> </paragraph> <paragraph num="(4)"> <text>Has fulfilled the continuing education requirements of the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before a teacher's license to practice dentistry expires, the licensee may renew it for an additional term, if the licensee:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee specified in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a renewal application on the form that the Board provides.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before a general license to practice dental hygiene or a teacher's license to practice dental hygiene expires, the licensee may renew it for an additional term, if the licensee:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee specified in COMAR 10.44.20;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a renewal application on the form the Board provides; and</text> </paragraph> <paragraph num="(4)"> <text>Has fulfilled the continuing education requirements of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A limited license to practice dentistry is not renewable.</text> </paragraph> <paragraph num="E."> <text>Following the expiration date of a license to practice dentistry or dental hygiene in the State, the licensee may renew the license within 30 days of its expiration if the licensee:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board a completed renewal application on the form provided by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Board the renewal fee and the late renewal fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Dental License.</text> <paragraph num="(1)"> <text>A licensee who has failed to renew a license to practice dentistry in this State by July 31 of the year in which the license is due for renewal is prohibited from practicing dentistry in this State after the expiration date of the license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reinstate the license if the licensee:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements for renewal and reinstatement of a license as provided in this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Submits to the Board a completed renewal application on the form provided by the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Pays to the Board the reinstatement fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board determines that a dentist has practiced dentistry in this State after the license has expired, the Board may order the dentist to immediately cease and desist the practice of dentistry in this State until the dentist's license has been reinstated by the Board.</text> </paragraph> <paragraph num="(4)"> <text>The Board may take action against a dentist for unprofessional conduct if it determines that the dentist has practiced dentistry in this State after the dentist's license has expired. The Board may:</text> <paragraph num="(a)"> <text>Impose an administrative penalty through a nonpublic consent agreement which the dentist agrees to make an anonymous donation of $400 to a charitable institution and to perform 40 hours of Board-approved pro bono dental services;</text> </paragraph> <paragraph num="(b)"> <text>Provide the dentist with a settlement conference; or</text> </paragraph> <paragraph num="(c)"> <text>Charge the dentist with unprofessional conduct as provided in Health Occupations Article, §4-315(a)(16), Annotated Code of Maryland, for practicing dentistry without a license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Dental Hygienist License.</text> <paragraph num="(1)"> <text>A licensee who has failed to renew a license to practice dental hygiene in this State by July 31 of the year in which the license is due for renewal is prohibited from practicing dental hygiene in this State after the expiration date of the license.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall reinstate the license if the licensee:</text> <paragraph num="(a)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements for renewal and reinstatement of a license as provided in this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Submits to the Board a completed renewal application on the form provided by the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Pays to the Board the reinstatement fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board determines that a dental hygienist has practiced dental hygiene in this State after the license has expired, the Board may order the dental hygienist to immediately cease and desist the practice of dental hygiene in this State until the dental hygienist's license has been reinstated by the Board.</text> </paragraph> <paragraph num="(4)"> <text>The Board may take action against a dental hygienist for unprofessional conduct if it determines that the dental hygienist has practiced dental hygiene in this State after the dental hygienist's license has expired. The Board may:</text> <paragraph num="(a)"> <text>Impose an administrative penalty through a nonpublic consent agreement which the dental hygienist agrees to make an anonymous donation of $200 to a charitable institution and to perform 20 hours of Board-approved pro bono dental services;</text> </paragraph> <paragraph num="(b)"> <text>Provide the dental hygienist with a settlement conference; or</text> </paragraph> <paragraph num="(c)"> <text>Charge the dental hygienist with unprofessional conduct as provided in Health Occupations Article, §4-315(b)(3), Annotated Code of Maryland, for practicing dental hygiene without a license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reinstatement of Expired Licenses."> <paragraph num="A."> <text>An individual holding an expired general license to practice dentistry may apply for reinstatement if the individual:</text> <paragraph num="(1)"> <text>Submits to the Board notarized affidavits, or other evidence satisfactory to the Board, that the applicant has actively practiced dentistry within the 3 years immediately preceding the date of application for reinstatement;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board satisfactory proof of licensure and good standing from all states in which the applicant is currently licensed;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board an application for reinstatement on a form provided by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(5)"> <text>Pays the reinstatement fee specified in COMAR 10.44.20;</text> </paragraph> <paragraph num="(6)"> <text>Has fulfilled the continuing education requirements of the Board; and</text> </paragraph> <paragraph num="(7)"> <text>Passes a written Maryland Law Examination given by the Board with at least a score of 75.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual holding an expired dental or dental hygiene teacher's license may apply for reinstatement if the individual:</text> <paragraph num="(1)"> <text>Submits to the Board satisfactory proof of licensure and good standing from all states in which the applicant is currently licensed;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board an application for reinstatement on a form provided by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(4)"> <text>Pays the reinstatement fee specified in COMAR 10.44.20;</text> </paragraph> <paragraph num="(5)"> <text>Has fulfilled the continuing education requirements of the Board; and</text> </paragraph> <paragraph num="(6)"> <text>Passes a written Maryland Law Examination given by the Board with at least a score of 75.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual holding an expired general license to practice dental hygiene may apply for reinstatement if the individual:</text> <paragraph num="(1)"> <text>Submits to the Board notarized affidavits, or other evidence satisfactory to the Board, that the applicant has actively practiced dental hygiene within the 3 years immediately preceding the date of application for reinstatement;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board satisfactory proof of licensure and good standing from all states in which the applicant is currently licensed;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board an application for reinstatement on a form provided by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(5)"> <text>Pays the reinstatement fee specified in COMAR 10.44.20;</text> </paragraph> <paragraph num="(6)"> <text>Has fulfilled the continuing education requirements of the Board; and</text> </paragraph> <paragraph num="(7)"> <text>Passes a written Maryland Law Examination given by the Board with at least a score of 75.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual holding a license to practice dentistry or dental hygiene which has been expired for more than 3 years may not apply for reinstatement under this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-309 and 4-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 4, 1984 (11:11 Md. R. 962)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective March 8, 1999 (26:5 Md. R. 391)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F, G adopted effective September 20, 1999 (26:19 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 6, 1990 (17:15 Md. R. 1860); August 24, 1998 (25:17 Md. R. 1360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A—C amended effective September 20, 1999 (26:19 Md. R. 1448)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 4, 2000 (27:17 Md. R. 1620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 29, 2004 (31:6 Md. R. 509)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective February 17, 2003 (30:3 Md. R. 181)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 29, 2004 (31:6 Md. R. 509); June 21, 2004 (31:12 Md. R. 913)</annotation> </annotations> </chapter> <chapter num="11" heading="Inactive Licenses"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Active Practice.</text> <paragraph num="(a)"> <text>“Active practice” with respect to dentistry means the practice of dentistry for at least 500 hours within the 36-month period preceding expiration of a license.</text> </paragraph> <paragraph num="(b)"> <text>“Active practice” with respect to dental hygiene means the practice of dental hygiene for at least 150 hours within the 36-month period preceding expiration of a license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Approved school” means a school determined by the Commission on Dental Accreditation to have met minimum standards.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Board of Dental Examiners.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Voluntary Change of License from Active to Inactive Status."> <text>After receipt of a renewal application from the Board and before expiration of the current license, a dentist or dental hygienist who holds a general license may inform the Board on the renewal application of the licensee's intent to change the status of the license from active to inactive.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Terms and Conditions of an Inactive Status Certificate."> <paragraph num="A."> <text>A licensee assigned inactive status shall submit to the Board the inactive status:</text> <paragraph num="(1)"> <text>Application form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall issue an inactive status certificate to a licensee whose license is placed on inactive status.</text> </paragraph> <paragraph num="C."> <text>An inactive status certificate expires on June 30 of the second year following the effective date of the certificate.</text> </paragraph> <paragraph num="D."> <text>Before an inactive status certificate expires, the licensee may renew the certificate if the licensee:</text> <paragraph num="(1)"> <text>Submits to the Board a renewal application on the form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the inactive status application fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee whose license is on inactive status may not practice in Maryland unless otherwise authorized by law.</text> </paragraph> <paragraph num="F."> <text>The practice of dentistry or dental hygiene in Maryland by a licensee whose license is on inactive status constitutes the unauthorized practice of dentistry or dental hygiene unless the practice is otherwise authorized by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reactivating a Dental or Dental Hygiene Certificate on Inactive Status."> <paragraph num="A."> <text>A licensee whose license to practice dentistry or dental hygiene is on inactive status may apply for reactivation of that license.</text> </paragraph> <paragraph num="B."> <text>A licensee who applies for reactivation of a dental or dental hygienist license shall submit to the Board:</text> <paragraph num="(1)"> <text>A completed application form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Notarized affidavits or other evidence satisfactory to the Board that the applicant has actively practiced within the 36 months immediately preceding the application date;</text> </paragraph> <paragraph num="(3)"> <text>Satisfactory proof of good standing from all states in which the applicant is currently licensed;</text> </paragraph> <paragraph num="(4)"> <text>Satisfactory evidence of completion, during the 2 years preceding application, of continuing education courses or programs equivalent in hours and type to those required of licensees by the Board; and</text> </paragraph> <paragraph num="(5)"> <text>Satisfactory evidence of passage, within 3 months of the application date, of the Board's jurisprudence examination.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to submitting an application as required under §B of this regulation, an applicant for reactivation of a license shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Arrange for the National Practitioner's Data Bank to forward a report of the applicant's disciplinary activity to the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Pay to the Board the difference between the license renewal fee and the inactive status application fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the applicant is unable to demonstrate active practice within the 36 months immediately preceding application for reactivation of a license, the applicant shall:</text> <paragraph num="(1)"> <text>Pass the North East Regional Board examination; or</text> </paragraph> <paragraph num="(2)"> <text>Have passed the North East Regional Board examination.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 1, 1983 (10:15 Md. R. 1351)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 20, 1994 (21:23 Md. R. 1933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 20, 1994 (21:23 Md. R. 1933)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Fee for Inactive Status, repealed and new chapter, Inactive Licenses, adopted effective March 8, 1999 (26:5 Md. R. 392)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 4, 2000 (27:17 Md. R. 1620)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 21, 2004 (31:12 Md. R. 913)</annotation> </annotations> </chapter> <chapter num="12" heading="Anesthesia and Sedation"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter covers the use of anesthesia and sedation by dentists in Maryland for the practice of dentistry.</text> </paragraph> <paragraph num="B."> <text>The use of local anesthesia by a dentist is not governed by this chapter.</text> </paragraph> <paragraph num="C."> <text>The administration of anesthesia and sedation by dentists in hospitals licensed in Maryland is not governed by this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose."> <text>Dentists are increasingly administering anesthesia and sedation on an outpatient basis. It is in the best interests of the public and the dentists of Maryland to require dentists who administer anesthesia and sedation to meet certain minimal training and competency standards. Requiring a dentist to obtain a permit before the dentist may administer anesthesia, sedation, or both is the best method to ensure that such administration is performed by competent dentists trained in the use of such techniques.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited facility” means a facility holding current certification from:</text> <paragraph num="(a)"> <text>The Accreditation Association for Ambulatory Health Care (AAAHC);</text> </paragraph> <paragraph num="(b)"> <text>The Joint Commission on Accreditation of Healthcare Organizations (JCAHO);</text> </paragraph> <paragraph num="(c)"> <text>The Joint Commission Ambulatory Health Care Accreditation (JCAHCA);</text> </paragraph> <paragraph num="(d)"> <text>The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF); or</text> </paragraph> <paragraph num="(e)"> <text>Their successor organizations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Administration evaluation” means an evaluation by the Board or its designee to determine if an applicant for a permit demonstrates knowledge of management of emergencies and anesthesia techniques to a level that meets the requirements of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Advanced Cardiac Life Support (ACLS)” means a certification that an individual has successfully completed an advanced cardiac life support course offered by the American Heart Association or other entity approved by the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Anesthesia” means an artificially induced insensibility to pain usually achieved by the administration of gases or the use of drugs.</text> </paragraph> <paragraph num="(5)"> <text>“Anesthesia and sedation” means:</text> <paragraph num="(a)"> <text>Moderate sedation;</text> </paragraph> <paragraph num="(b)"> <text>Deep sedation; and</text> </paragraph> <paragraph num="(c)"> <text>General anesthesia.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Anxiolysis.</text> <paragraph num="(a)"> <text>“Anxiolysis” means a drug-induced state, with or without nitrous oxide/oxygen to decrease anxiety, in which patients respond normally to tactile stimulation and verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are maintained and require no assistance.</text> </paragraph> <paragraph num="(b)"> <text>“Anxiolysis” includes a single dose of one sedative, narcotic, class of drugs, or medication prescribed by the treating dentist and taken the evening before a procedure or the morning of a procedure, or both, provided that the dosage complies with the definition of anxiolysis under §B(6)(a) of this regulation.</text> </paragraph> <paragraph num="(c)"> <text>“Anxiolysis” does not include the administering, prescribing, or dispensing of any other sedative, narcotic, class of drugs, or medication for the purpose of anesthesia by a dentist to a patient to be used for anesthesia or sedation, to be taken the evening before a procedure or the morning of a procedure.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Board” means the State Board of Dental Examiners.</text> </paragraph> <paragraph num="(8)"> <text>“Certified registered nurse anesthetist” means a registered nurse who is currently certified to practice nurse anesthesia in Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Deep sedation” means a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Cardiovascular function is usually maintained.</text> </paragraph> <paragraph num="(10)"> <text>“Dentist” means an individual who holds a current license to practice dentistry in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Facility” means any location in which anesthesia or sedation is administered for the practice of dentistry.</text> </paragraph> <paragraph num="(12)"> <text>“Facility evaluation” means an on-site inspection by the Board or its designee to determine if a facility where the applicant proposes to provide anesthesia and sedation is adequately supplied, equipped, staffed, and maintained in a condition to support the provision of anesthesia and sedation services in a manner that meets the requirements of this chapter.</text> </paragraph> <paragraph num="(13)"> <text>“General anesthesia” means a drug-induced loss of consciousness during which patients are not arousable even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation, drug-induced depression, or changes in neuromuscular function. Cardiovascular function may be impaired.</text> </paragraph> <paragraph num="(14)"> <text>“General anesthesia administration permit” means a permit that was issued by the Board before January 4, 2010, that authorized the dentist to whom the permit was issued to administer general anesthesia for the practice of dentistry.</text> </paragraph> <paragraph num="(15)"> <text>“General anesthesia facility permit” means a permit that was issued by the Board before January 4, 2010, that authorized the administration of general anesthesia for the practice of dentistry in the facility named in the permit.</text> </paragraph> <paragraph num="(16)"> <text>“Incident” means dental treatment performed on a patient under moderate sedation, deep sedation, or general anesthesia with unforeseen complications.</text> </paragraph> <paragraph num="(17)"> <text>“Moderate enteral sedation” means a drug-induced depression of consciousness through the gastrointestinal tract or oral mucosa during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.</text> </paragraph> <paragraph num="(18)"> <text>“Moderate parenteral sedation” means a drug-induced depression of consciousness that bypasses the gastrointestinal tract or oral mucosa during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.</text> </paragraph> <paragraph num="(19)"> <text>“Moderate sedation” means a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is maintained.</text> </paragraph> <paragraph num="(20)"> <text>“Parenteral” means a technique of administration in which the drug bypasses the gastrointestinal tract, that is, through an intramuscular, intravenous, intranasal, submucosal, subcutaneous, or intraosseous technique.</text> </paragraph> <paragraph num="(21)"> <text>“Parenteral sedation administration permit” means a permit that was issued by the Board before January 4, 2010, that authorized the dentist to whom the permit was issued to administer parenteral sedation for the practice of dentistry.</text> </paragraph> <paragraph num="(22)"> <text>“Parenteral sedation facility permit” means a permit that was issued by the Board before January 4, 2010, that authorized the administration of parenteral sedation for the practice of dentistry in the facility named in the permit.</text> </paragraph> <paragraph num="(23)"> <text>“Pediatric Advanced Life Support (PALS)” means a certification that an individual has successfully completed a pediatric advanced life support course offered by the American Heart Association or other entity approved by the Board.</text> </paragraph> <paragraph num="(24)"> <text>“Physician” means a physician, including a doctor of osteopathy, who holds a current license to practice medicine in Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Renewal evaluation” means an on-site inspection by the Board or its designee before the renewal of a permit to determine if a facility where the applicant proposes to provide anesthesia and sedation is adequately supplied, equipped, staffed, and maintained in a condition to support the provision of anesthesia and sedation services in a manner that meets the requirements of this chapter.</text> </paragraph> <paragraph num="(26)"> <text>“Sedation” means the reduction of stress or excitement by the administration of a drug that has a soothing, calming, or tranquilizing effect.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Anxiolysis."> <paragraph num="A."> <text>A permit is not required for a dentist to administer anxiolysis.</text> </paragraph> <paragraph num="B."> <text>The administering, prescribing, or dispensing of more than one type of sedative, narcotic, class of drug, or medication for the purpose of anesthesia to be taken the evening before a procedure, or the morning of a procedure, is not anxiolysis and shall require the appropriate anesthesia or sedation permit.</text> </paragraph> <paragraph num="C."> <text>A dentist who intends to administer anxiolysis shall indicate the intent to administer anxiolysis in the patient's records.</text> </paragraph> <paragraph num="D."> <text>A dentist who administers anxiolysis may not administer a dose that is inappropriate for a patient's:</text> <paragraph num="(1)"> <text>Age;</text> </paragraph> <paragraph num="(2)"> <text>Weight;</text> </paragraph> <paragraph num="(3)"> <text>Medical condition;</text> </paragraph> <paragraph num="(4)"> <text>Infirmities; or</text> </paragraph> <paragraph num="(5)"> <text>Other propensities.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Medications used to produce anxiolysis may not exceed current limits set by the manufacturer for unmonitored use by the individual.</text> </paragraph> <paragraph num="F."> <text>A dentist who administers anxiolysis shall maintain a margin of safety and a level of consciousness that does not approach moderate sedation and other deeper states of sedation and general anesthesia.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Classifications of Permits and Certificates."> <paragraph num="A."> <text>The following permits shall be issued by the Board:</text> <paragraph num="(1)"> <text>Class I permit that authorizes a dentist to use a nonparenteral anesthetic technique to attain the level of moderate sedation;</text> </paragraph> <paragraph num="(2)"> <text>Class II permit that authorizes a dentist to use:</text> <paragraph num="(a)"> <text>A parenteral anesthetic technique to attain the level of moderate sedation; and</text> </paragraph> <paragraph num="(b)"> <text>Any procedure allowed with a Class I permit;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Class III permit that authorizes a dentist to use:</text> <paragraph num="(a)"> <text>An anesthetic technique to attain the level of deep sedation or general anesthesia; and</text> </paragraph> <paragraph num="(b)"> <text>Any procedure allowed under either a Class I permit or a Class II permit; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Class III dental school facility permit issued to a dental school that allows a dentist who holds the appropriate Class I, Class II, or Class III permit to administer anesthesia or sedation in a dental school recognized by the Commission on Dental Accreditation or its successor organization.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following certificates shall be issued to qualified dentists by the Board:</text> <paragraph num="(1)"> <text>Certificate to allow a physician or another dentist to administer anesthesia and sedation, which allows a physician or another dentist to administer anesthesia and sedation to a patient at a specific practice location;</text> </paragraph> <paragraph num="(2)"> <text>Certificate to allow a dentist to treat a patient at a practice location other than their own at which anesthesia and sedation is administered, which allows a dentist to treat a patient at a practice location other than their own in which anesthesia and sedation is administered; and</text> </paragraph> <paragraph num="(3)"> <text>Certificate to allow a certified registered nurse anesthetist to administer anesthesia and sedation, which allows a certified registered nurse anesthetist to administer anesthesia and sedation to a patient at a specific practice location.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Permit Required."> <text>After January 4, 2010, a dentist may not administer an anesthetic technique in order to attain a level beyond anxiolysis for the practice of dentistry unless the dentist holds an appropriate Class I, II, or III permit issued by the Board.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Location Requirement."> <paragraph num="A."> <text>On a form provided by the Board, a dentist shall advise the Board of the name and address of each location where the dentist wishes to administer anesthesia and sedation.</text> </paragraph> <paragraph num="B."> <text>A dentist may not administer anesthesia and sedation unless the dentist has obtained the appropriate permit for each location.</text> </paragraph> <paragraph num="C."> <text>On a form provided by the Board, a dentist shall advise the Board of each location at which the dentist has ceased to administer anesthesia and sedation.</text> </paragraph> <paragraph num="D."> <text>The Board shall keep a record of:</text> <paragraph num="(1)"> <text>Each location for which a dentist has been granted a permit to administer anesthesia and sedation; and</text> </paragraph> <paragraph num="(2)"> <text>Each location at which a dentist has ceased to administer anesthesia and sedation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Qualifications for Obtaining a Permit."> <paragraph num="A."> <text>Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Therefore, practitioners intending to produce a given level of sedation shall be able to recover patients whose level of sedation becomes deeper than initially intended. Individuals administering moderate enteral sedation or moderate parenteral sedation shall be able to recover patients who enter a state of deep sedation or general anesthesia, while those administering deep sedation shall be able to recover patients who enter a state of general anesthesia. Training and evaluation guidelines shall reflect this concern.</text> </paragraph> <paragraph num="B."> <text>In addition to the requirements outlined in this regulation, in order to obtain a permit, a dentist shall also meet the requirements outlined in Regulations .09—.11 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A permit may be issued to a dentist authorizing the use of moderate sedation, deep sedation, or general anesthesia at a specific practice location.</text> </paragraph> <paragraph num="D."> <text>Class I: Moderate Enteral Sedation Permit. To qualify for a Class I permit, an applicant shall successfully complete:</text> <paragraph num="(1)"> <text>A Board-approved course of instruction that documents training of at least 24 hours of didactic education plus 20 clinically oriented experiences that provide competency in oral and combination inhalation-oral moderate sedation; or</text> </paragraph> <paragraph num="(2)"> <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage moderate enteral sedation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Clinically oriented experiences referred to in §D(1) of this regulation may include:</text> <paragraph num="(1)"> <text>Supervised administration;</text> </paragraph> <paragraph num="(2)"> <text>Observations of videotaped patients undergoing oral or combination inhalation-oral moderate sedation; or</text> </paragraph> <paragraph num="(3)"> <text>Human simulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In addition to the requirements outlined in §D of this regulation, an applicant for a Class I permit shall:</text> <paragraph num="(1)"> <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire, or successfully complete a course approved by the Board that provides instruction on medical emergencies and airway management;</text> </paragraph> <paragraph num="(2)"> <text>Receive a successful evaluation by the Board or the Board's designee;</text> </paragraph> <paragraph num="(3)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text> </paragraph> <paragraph num="(4)"> <text>Submit any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An affidavit provided to the Board under §F(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include at least the following:</text> <paragraph num="(1)"> <text>The date of the incident;</text> </paragraph> <paragraph num="(2)"> <text>The name, age, and address of the patient;</text> </paragraph> <paragraph num="(3)"> <text>The patient's original complete dental records;</text> </paragraph> <paragraph num="(4)"> <text>The name and license number of the licensee and the name and address of all other persons present during the incident;</text> </paragraph> <paragraph num="(5)"> <text>The address where the incident took place;</text> </paragraph> <paragraph num="(6)"> <text>The preoperative physical condition of the patient;</text> </paragraph> <paragraph num="(7)"> <text>The type of anesthesia and dosages of drugs administered to the patient;</text> </paragraph> <paragraph num="(8)"> <text>The techniques used in administering the drugs;</text> </paragraph> <paragraph num="(9)"> <text>Any adverse occurrence including:</text> <paragraph num="(a)"> <text>The patient's signs and symptoms;</text> </paragraph> <paragraph num="(b)"> <text>The treatments instituted in response to adverse occurrences;</text> </paragraph> <paragraph num="(c)"> <text>The patient's response to the treatment; and</text> </paragraph> <paragraph num="(d)"> <text>The patient's condition on termination of any procedures undertaken; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A narrative description of the incident including approximate times and evolution of symptoms.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Class II: Moderate Parenteral Sedation Permit. To qualify for a Class II permit, an applicant shall successfully complete:</text> <paragraph num="(1)"> <text>A Board-approved course of instruction that documents training of at least 60 hours of didactic instruction plus management of at least 20 dental patients, who may be simulated, per participant in moderate parenteral sedation techniques; or</text> </paragraph> <paragraph num="(2)"> <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage moderate parenteral sedation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>In addition to the requirements outlined in §§H and I of this regulation, an applicant for a Class II permit shall:</text> <paragraph num="(1)"> <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire;</text> </paragraph> <paragraph num="(2)"> <text>Receive a successful evaluation by the Board or the Board's designee;</text> </paragraph> <paragraph num="(3)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text> </paragraph> <paragraph num="(4)"> <text>Submit any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="J."> <text>An affidavit provided to the Board under §I(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in §G of this regulation.</text> </paragraph> <paragraph num="K."> <text>Class III: Deep Sedation and General Anesthesia Permit. To qualify for a Class III permit, an applicant shall have successfully completed:</text> <paragraph num="(1)"> <text>An advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum that is approved by the Board; or</text> </paragraph> <paragraph num="(2)"> <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage deep sedation and general anesthesia.</text> </paragraph> </paragraph> <paragraph num="L."> <text>In addition to the requirements outlined in §I of this regulation, an applicant for a Class III permit shall:</text> <paragraph num="(1)"> <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire;</text> </paragraph> <paragraph num="(2)"> <text>Receive a successful evaluation by the Board or its designee;</text> </paragraph> <paragraph num="(3)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text> </paragraph> <paragraph num="(4)"> <text>Submit any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="M."> <text>An affidavit provided to the Board under §L(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in §G of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Administration Evaluation."> <paragraph num="A."> <text>Class I Permit. To qualify for a Class I permit, the dentist who will perform the administration shall pass:</text> <paragraph num="(1)"> <text>An office inspection evaluation;</text> </paragraph> <paragraph num="(2)"> <text>A clinical evaluation consistent with the age level of the patients treated by the dentist;</text> </paragraph> <paragraph num="(3)"> <text>An evaluation of the dentist to safely administer sedation techniques; and</text> </paragraph> <paragraph num="(4)"> <text>An evaluation of the ability of the dentist to effectively respond to sedation related emergencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The clinical evaluation required in §A of this regulation shall require the participation of the office staff.</text> </paragraph> <paragraph num="C."> <text>The clinical evaluation required by §A(2) of this regulation shall include evaluating treatment of at least the following:</text> <paragraph num="(1)"> <text>Laryngospasm;</text> </paragraph> <paragraph num="(2)"> <text>Foreign body airway obstruction;</text> </paragraph> <paragraph num="(3)"> <text>Emergency airway management;</text> </paragraph> <paragraph num="(4)"> <text>Emesis and aspiration;</text> </paragraph> <paragraph num="(5)"> <text>Acute allergic reaction;</text> </paragraph> <paragraph num="(6)"> <text>Bronchospasm;</text> </paragraph> <paragraph num="(7)"> <text>Angina;</text> </paragraph> <paragraph num="(8)"> <text>Conditions requiring advanced cardiac life support, including:</text> <paragraph num="(a)"> <text>Bradycardia;</text> </paragraph> <paragraph num="(b)"> <text>Tachycardia;</text> </paragraph> <paragraph num="(c)"> <text>Ventricular fibrillation; and</text> </paragraph> <paragraph num="(d)"> <text>Cardiac arrest;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Hypotension;</text> </paragraph> <paragraph num="(10)"> <text>Hypoglycemia;</text> </paragraph> <paragraph num="(11)"> <text>Hypertension;</text> </paragraph> <paragraph num="(12)"> <text>Seizure; and</text> </paragraph> <paragraph num="(13)"> <text>Syncope.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Class II or Class III Permit.</text> <paragraph num="(1)"> <text>To qualify for a Class II or Class III permit, the dentist who will perform the administration shall pass an administration evaluation that consists of an office inspection and clinical evaluation.</text> </paragraph> <paragraph num="(2)"> <text>The clinical evaluation required by §D(1) of this regulation shall:</text> <paragraph num="(a)"> <text>Require the participation of the clinical office staff; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate the technical competency of the dentist to:</text> <paragraph num="(i)"> <text>Safely administer moderate parenteral sedation, deep sedation, or general anesthesia; and</text> </paragraph> <paragraph num="(ii)"> <text>Effectively respond to anesthesia related emergencies.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The clinical evaluation required by §D(1) of this regulation shall include evaluating the treatment of at least the following:</text> <paragraph num="(1)"> <text>Laryngospasm;</text> </paragraph> <paragraph num="(2)"> <text>Foreign body airway obstruction;</text> </paragraph> <paragraph num="(3)"> <text>Emergency airway management;</text> </paragraph> <paragraph num="(4)"> <text>Emesis and aspiration;</text> </paragraph> <paragraph num="(5)"> <text>Acute allergic reaction;</text> </paragraph> <paragraph num="(6)"> <text>Bronchospasm;</text> </paragraph> <paragraph num="(7)"> <text>Angina;</text> </paragraph> <paragraph num="(8)"> <text>Conditions requiring advanced cardiac life support, including:</text> <paragraph num="(a)"> <text>Bradycardia;</text> </paragraph> <paragraph num="(b)"> <text>Tachycardia;</text> </paragraph> <paragraph num="(c)"> <text>Ventricular fibrillation; and</text> </paragraph> <paragraph num="(d)"> <text>Cardiac arrest;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Hypotension;</text> </paragraph> <paragraph num="(10)"> <text>Hypoglycemia;</text> </paragraph> <paragraph num="(11)"> <text>Hypertension;</text> </paragraph> <paragraph num="(12)"> <text>Seizure;</text> </paragraph> <paragraph num="(13)"> <text>Syncope; and</text> </paragraph> <paragraph num="(14)"> <text>Venipuncture complications.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Facility Evaluation."> <text>In addition to the requirements outlined in Regulation .09 of this chapter, for a dentist to obtain a Class I, Class II, or Class III permit, each facility in which the dentist wishes to administer an anesthesia technique shall pass a facility evaluation in order to attain:</text> <paragraph num="A."> <text>A level beyond anxiolysis;</text> </paragraph> <paragraph num="B."> <text>Moderate enteral sedation;</text> </paragraph> <paragraph num="C."> <text>Moderate parenteral sedation; or</text> </paragraph> <paragraph num="D."> <text>Deep sedation and general anesthesia.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Facility Evaluation Criteria."> <paragraph num="A."> <text>Except as otherwise provided in this regulation, to qualify for a permit, the facility and the applicant shall pass an evaluation of facility equipment, medications, and clinical records to include at least the following:</text> <paragraph num="(1)"> <text>Oxygen and gas delivery system, backup system fail-safe;</text> </paragraph> <paragraph num="(2)"> <text>Gas storage facility;</text> </paragraph> <paragraph num="(3)"> <text>Safety indexed gas system;</text> </paragraph> <paragraph num="(4)"> <text>Suction and backup system;</text> </paragraph> <paragraph num="(5)"> <text>Auxiliary lighting system;</text> </paragraph> <paragraph num="(6)"> <text>Suitability of operating room:</text> <paragraph num="(a)"> <text>Size;</text> </paragraph> <paragraph num="(b)"> <text>Lighting;</text> </paragraph> <paragraph num="(c)"> <text>Communications; and</text> </paragraph> <paragraph num="(d)"> <text>EMT accessibility;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Recovery area, including oxygen, suction, and visual and electronic monitoring, which may include the operating room;</text> </paragraph> <paragraph num="(8)"> <text>Appropriate emergency drugs;</text> </paragraph> <paragraph num="(9)"> <text>Nonexpired drugs;</text> </paragraph> <paragraph num="(10)"> <text>Appropriate devices to maintain an airway with positive pressure ventilation;</text> </paragraph> <paragraph num="(11)"> <text>Preoperative medical history and physical evaluation form;</text> </paragraph> <paragraph num="(12)"> <text>Anesthesia records, including monitoring and discharge records;</text> </paragraph> <paragraph num="(13)"> <text>Monitoring equipment, including pulse oximeter and blood pressure monitoring;</text> </paragraph> <paragraph num="(14)"> <text>Anesthesia and monitoring equipment to ensure they are in proper working order;</text> </paragraph> <paragraph num="(15)"> <text>Defibrillator or automated external defibrillator (AED);</text> </paragraph> <paragraph num="(16)"> <text>For deep sedation or general anesthesia in pediatric patients:</text> <paragraph num="(a)"> <text>A precordial stethoscope;</text> </paragraph> <paragraph num="(b)"> <text>A pretracheal stethoscope; or</text> </paragraph> <paragraph num="(c)"> <text>A capnograph; and</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>For Class II and Class III permits:</text> <paragraph num="(a)"> <text>An electrocardiogram (EKG);</text> </paragraph> <paragraph num="(b)"> <text>A capnograph measuring device; and</text> </paragraph> <paragraph num="(c)"> <text>Pulse oximeter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements outlined in §A of this regulation, to qualify for a permit, the dentist who will perform the administration and the dentist's staff shall be present in the operatory during the evaluation.</text> </paragraph> <paragraph num="C."> <text>An applicant for a permit may not transport anesthesia or sedation equipment from one dental office to another for facility examination purposes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Evaluation Results."> <paragraph num="A."> <text>A Board evaluator shall hold a permit at the same or higher level as the permit sought by the applicant being evaluated.</text> </paragraph> <paragraph num="B."> <text>To the extent practicable, a Board evaluator shall provide the results of the evaluation to the Board in writing within 7 days of an applicant’s evaluation.</text> </paragraph> <paragraph num="C."> <text>Either the Board or the Board’s Anesthesia Committee shall:</text> <paragraph num="(1)"> <text>Review the results of the evaluation; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the applicant of the results in a timely manner.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If requested, an applicant shall be provided with a copy of the evaluation provided to the Board.</text> </paragraph> <paragraph num="E."> <text>An applicant who fails either an administration evaluation or a facility evaluation twice shall be required to pay a fee equal to the renewal fee for the permit sought by the applicant before either the third evaluation or any subsequent evaluations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Exceptions."> <paragraph num="A."> <text>A dentist who has passed an administration and facility evaluation for a Class I, Class II, or Class III permit may receive a like permit for another facility or facilities if:</text> <paragraph num="(1)"> <text>The dentist holds an active Class I, Class II, or Class III permit for which the dentist has passed an administration and facility evaluation; and</text> </paragraph> <paragraph num="(2)"> <text>Each facility for which the dentist seeks another permit has at least one dentist who has passed an administration and facility evaluation for a like permit at that location within 2 years of the date of application for the additional permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Alternatively, a dentist who has passed an administration and facility evaluation for a Class I, Class II, or Class III permit may receive a like permit for another facility or facilities if:</text> <paragraph num="(1)"> <text>The dentist holds an active Class I, Class II, or Class III permit for which the dentist has passed an administration and facility evaluation; and</text> </paragraph> <paragraph num="(2)"> <text>The dentist seeking the additional permit:</text> <paragraph num="(a)"> <text>Is present during a facility evaluation at which the dentist and the dentist's staff pass a facility evaluation; and</text> </paragraph> <paragraph num="(b)"> <text>Passes an evaluation, appropriate for the permit level, that includes simulated management of emergencies with the participation of the clinical office staff trained to handle emergencies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §§A and B of this regulation, the dentist seeking the additional permit or permits shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pay the appropriate fee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Inducing a Level of Sedation for a Patient."> <paragraph num="A."> <text>Administration of moderate enteral sedation, moderate parenteral sedation, deep sedation, or general anesthesia to a patient requires at least the following appropriately trained individuals:</text> <paragraph num="(1)"> <text>The treating dentist;</text> </paragraph> <paragraph num="(2)"> <text>An individual trained and competent in basic life support or its equivalent to assist the treating dentist; and</text> </paragraph> <paragraph num="(3)"> <text>Another individual trained and competent in basic life support or its equivalent in close proximity to assist if needed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist administering moderate enteral sedation, moderate parenteral sedation, deep sedation, or general anesthesia to a patient:</text> <paragraph num="(1)"> <text>May not leave the site until the patient:</text> <paragraph num="(a)"> <text>Is conscious;</text> </paragraph> <paragraph num="(b)"> <text>Is spontaneously breathing;</text> </paragraph> <paragraph num="(c)"> <text>Has stable vital signs;</text> </paragraph> <paragraph num="(d)"> <text>Is ambulatory with assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Is under the care of a responsible adult; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May not induce a second patient until the first patient:</text> <paragraph num="(a)"> <text>Is conscious;</text> </paragraph> <paragraph num="(b)"> <text>Is spontaneously breathing;</text> </paragraph> <paragraph num="(c)"> <text>Has stable vital signs;</text> </paragraph> <paragraph num="(d)"> <text>Is ambulatory with assistance; and</text> </paragraph> <paragraph num="(e)"> <text>Is under the care of a responsible adult.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A treating dentist who allows a physician, another dentist, or certified registered nurse anesthetist to administer moderate enteral sedation, moderate parenteral sedation, deep sedation, or general anesthesia under Regulation .31, .32, or .33 of this chapter shall ensure that the physician, dentist, or certified registered nurse anesthetist does not leave the site until the patient:</text> <paragraph num="(1)"> <text>Is conscious;</text> </paragraph> <paragraph num="(2)"> <text>Is spontaneously breathing;</text> </paragraph> <paragraph num="(3)"> <text>Has stable vital signs;</text> </paragraph> <paragraph num="(4)"> <text>Is ambulatory with assistance; and</text> </paragraph> <paragraph num="(5)"> <text>Is under the care of a responsible adult.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A treating dentist who allows a physician, another dentist, or certified registered nurse anesthetist to administer moderate sedation, deep sedation, or general anesthesia shall ensure that the physician, dentist, or certified registered nurse anesthetist does not induce a second patient until the first patient:</text> <paragraph num="(1)"> <text>Is conscious;</text> </paragraph> <paragraph num="(2)"> <text>Is spontaneously breathing;</text> </paragraph> <paragraph num="(3)"> <text>Has stable vital signs;</text> </paragraph> <paragraph num="(4)"> <text>Is ambulatory with assistance; and</text> </paragraph> <paragraph num="(5)"> <text>Is under the care of a responsible adult.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="General Anesthesia and Parenteral Sedation Administration Permits in Existence on January 4, 2010."> <paragraph num="A."> <text>A dentist who held a current general anesthesia administration permit on January 4, 2010, may continue to administer anesthesia and sedation under the general anesthesia administration permit until the expiration of the permit only as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>A dentist who held a current parenteral sedation administration permit on January 4, 2010, may continue to administer moderate parenteral sedation under the parenteral sedation administration permit until the expiration of the permit only as provided in this regulation.</text> </paragraph> <paragraph num="C."> <text>A dentist who held a current general anesthesia administration permit on January 4, 2010, may administer anesthesia and sedation under the general anesthesia administration permit, consistent with a Class III permit, only in a facility for which the dentist holds a current general anesthesia facility permit.</text> </paragraph> <paragraph num="D."> <text>A dentist who held a current general anesthesia administration permit on January 4, 2010, and who wishes to administer general anesthesia in a facility for which the dentist does not hold a general anesthesia facility permit shall apply for and be issued a Class III permit for that site in accordance with Regulations .07—.11 of this chapter.</text> </paragraph> <paragraph num="E."> <text>A dentist who held a current parenteral sedation administration permit on January 4, 2010, may administer parenteral sedation under the parenteral sedation administration permit consistent with a Class II permit, only in a facility for which the dentist holds a current parenteral sedation facility permit.</text> </paragraph> <paragraph num="F."> <text>A dentist who held a current parenteral sedation administration permit on January 4, 2010, and who wishes to administer parenteral sedation at a facility for which the dentist does not hold a parenteral sedation facility permit, shall apply for and be issued a Class II permit for that site in accordance with Regulations .07—.11 of this chapter.</text> </paragraph> <paragraph num="G."> <text>A dentist whose general anesthesia administration permit has expired may not administer general anesthesia unless the dentist holds a Class III permit issued by the Board.</text> </paragraph> <paragraph num="H."> <text>A dentist whose parenteral sedation administration permit has expired may not administer parenteral sedation unless the dentist holds a Class II permit issued by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="General Anesthesia and Parenteral Sedation Facility Permits in Existence on January 4, 2010."> <paragraph num="A."> <text>General anesthesia facility permits and parenteral sedation facility permits in existence on January 4, 2010, shall expire as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>A general anesthesia facility permit issued to a dentist who does not hold a general anesthesia administration permit shall expire on January 4, 2010.</text> </paragraph> <paragraph num="C."> <text>A parenteral sedation facility permit issued to a dentist who does not hold a parenteral sedation administration permit shall expire on January 4, 2010.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Conversion of General Anesthesia and Parenteral Sedation Administration Permits in Existence on January 4, 2010."> <paragraph num="A."> <text>At least 120 days before the expiration of a general anesthesia administration permit the Board shall mail an application to each individual who holds a general anesthesia administration permit to convert the general anesthesia administration permit to a Class III permit.</text> </paragraph> <paragraph num="B."> <text>At least 120 days before the expiration of a parenteral sedation administration permit the Board shall mail an application to each individual who holds a parenteral sedation administration permit to convert the parenteral sedation administration permit to a Class II permit.</text> </paragraph> <paragraph num="C."> <text>A dentist who held a current general anesthesia administration permit and a general anesthesia facility permit on January 4, 2010, and who wishes to receive a Class III permit for a location for which the dentist holds a current general anesthesia facility permit, may receive a Class III permit for the location for which the dentist held a general anesthesia facility permit if the applicant:</text> <paragraph num="(1)"> <text>Submits to the Board at least 90 days before the expiration of the permit an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Passes a renewal evaluation in each facility for which the applicant wishes to receive a Class III permit;</text> </paragraph> <paragraph num="(3)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20;</text> </paragraph> <paragraph num="(4)"> <text>Provides an affidavit to the Board indicating whether the applicant, since the issuance of the original general anesthesia administration permit, has treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(5)"> <text>Provides evidence satisfactory to the Board that the applicant meets the continuing education requirements outlined in Regulation .29 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Submits any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An affidavit provided to the Board under §C(4) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="E."> <text>The evaluation outlined in §C(2) of this regulation shall consist of an evaluation of:</text> <paragraph num="(1)"> <text>Anesthesia and monitoring equipment to ensure they are in proper working order;</text> </paragraph> <paragraph num="(2)"> <text>Simulated management of emergencies with the participation of the clinical office staff trained to handle emergencies; and</text> </paragraph> <paragraph num="(3)"> <text>Drugs in the office to ensure that the applicant:</text> <paragraph num="(a)"> <text>Maintains the appropriate drugs on the premises; and</text> </paragraph> <paragraph num="(b)"> <text>Only utilizes drugs on the premises the dates of which have not expired.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>If an applicant returns an application to the Board at least 90 days before the expiration of the permit, and the Board is unable to approve or deny the application before the expiration of the permit through no fault of the applicant, the permit shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Issues the permit; or</text> </paragraph> <paragraph num="(2)"> <text>Denies issuance of the permit.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Failure to receive the Board's application does not relieve a permit holder from the requirement to submit an application to the Board at least 90 days before the expiration of a permit.</text> </paragraph> <paragraph num="H."> <text>The Board may issue a Class III permit to an applicant for a specific practice location after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The evaluation; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints that may affect the applicant's ability to safely and effectively administer anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>This regulation does not preclude the Board from taking disciplinary action against a dentist who holds a:</text> <paragraph num="(1)"> <text>General anesthesia administration permit; or</text> </paragraph> <paragraph num="(2)"> <text>Class III permit.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A dentist who held a current parenteral sedation administration permit and a parenteral sedation facility permit on January 4, 2010, and who wishes to receive a Class II permit for the location for which the dentist holds a current parenteral sedation facility permit, may receive a Class II permit for the location for which the dentist held a parenteral sedation facility permit or permits if the applicant:</text> <paragraph num="(1)"> <text>Submits to the Board at least 90 days before the expiration of the permit:</text> <paragraph num="(a)"> <text>An application on a form provided by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Written verification of inspection of the applicant's anesthesia and monitoring equipment from a recognized service company; and</text> </paragraph> <paragraph num="(c)"> <text>Written verification from the applicant that:</text> <paragraph num="(i)"> <text>Since the issuance of the parenteral sedation administration permit, the applicant and the appropriate individuals in the applicant's staff have completed training in basic life support and the handling of medical emergencies;</text> </paragraph> <paragraph num="(ii)"> <text>The applicant maintains the appropriate drugs on the premises; and</text> </paragraph> <paragraph num="(iii)"> <text>The applicant only utilizes drugs on the premises the dates of which have not expired;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20;</text> </paragraph> <paragraph num="(3)"> <text>Provides an affidavit to the Board indicating whether the applicant, since the issuance of the original parenteral sedation administration permit, has treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(4)"> <text>Provides evidence satisfactory to the Board that the applicant meets the continuing education requirements outlined in Regulation .29 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Submits any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An affidavit provided to the Board under §J(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="L."> <text>The training in basic life support and the handling of emergencies outlined in §J(1)(c)(i) of this regulation shall be completed before the submission of each application.</text> </paragraph> <paragraph num="M."> <text>If an applicant returns an application to the Board at least 90 days before the expiration of a permit, and the Board is unable to approve or deny the application before the expiration of the permit through no fault of the applicant, the permit shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Issues the permit; or</text> </paragraph> <paragraph num="(2)"> <text>Denies issuance of the permit.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Failure to receive the Board's application does not relieve a permit holder from the requirement to submit an application to the Board at least 90 days before the expiration of a permit.</text> </paragraph> <paragraph num="O."> <text>The Board may issue a Class II permit to an applicant for a specific practice location after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints that may affect the applicant's ability to safely and effectively administer sedation.</text> </paragraph> </paragraph> <paragraph num="P."> <text>This regulation does not preclude the Board from taking disciplinary action against a dentist who holds a:</text> <paragraph num="(1)"> <text>Parenteral sedation administration permit; or</text> </paragraph> <paragraph num="(2)"> <text>Class II permit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Compliance for Dentists with General Anesthesia and Parenteral Sedation Administration Permits in Existence on January 4, 2010."> <text>A dentist with a general anesthesia administration permit or a parenteral sedation administration permit in existence on January 4, 2010, shall comply with Regulations .14, .26, .27, .30, .31, .32, and .34 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Issuance and Expiration of Class I, Class II, and Class III Permits."> <paragraph num="A."> <text>To apply to obtain a permit, an applicant shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the fee set by the Board in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(3)"> <text>Provide evidence satisfactory to the Board that the applicant meets the qualifications for a Class I, Class II, or Class III permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may issue a Class I, Class II, or Class III permit to an applicant for a specific practice location after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The applicant's administration evaluation;</text> </paragraph> <paragraph num="(4)"> <text>The applicant's facility evaluation; and</text> </paragraph> <paragraph num="(5)"> <text>Any other pertinent documents or information including, but not limited to, patient complaints that may affect the applicant's ability to safely and effectively administer anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A permit expires on April 1 of the 5th year following the effective date of the permit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Renewal of Class I and Class II Permits."> <paragraph num="A."> <text>The Board shall mail a renewal application to each individual holding a Class I or Class II permit at least 180 days before the expiration of the permit.</text> </paragraph> <paragraph num="B."> <text>Before a Class I or Class II permit expires, an applicant may apply to renew the permit for an additional 5-year term if the applicant:</text> <paragraph num="(1)"> <text>Submits to the Board at least 90 days before the expiration of the permit:</text> <paragraph num="(a)"> <text>A renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Written verification of inspection of the applicant's anesthesia and monitoring equipment from a recognized service company; and</text> </paragraph> <paragraph num="(c)"> <text>Written verification from the applicant that:</text> <paragraph num="(i)"> <text>Since the issuance of the permit or the previous renewal of the permit, the applicant and the appropriate individuals on the applicant's office staff have completed training in basic life support and the handling of medical emergencies;</text> </paragraph> <paragraph num="(ii)"> <text>The applicant maintains the appropriate drugs on the premises; and</text> </paragraph> <paragraph num="(iii)"> <text>The applicant only utilizes drugs on the premises the dates of which have not expired;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20;</text> </paragraph> <paragraph num="(3)"> <text>Provides an affidavit to the Board indicating whether the applicant, since the issuance of the original permit or renewal, whichever is later, has treated a patient under deep sedation or general anesthesia with an incident requiring admission to a hospital either for a period greater than 24 hours, or for purposes other than observation.</text> </paragraph> <paragraph num="(4)"> <text>Provides evidence satisfactory to the Board that the applicant meets the continuing education requirements outlined in Regulation .29 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Submits any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An affidavit provided to the Board under §B(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="D."> <text>The training in basic life support and the handling of medical emergencies outlined in §B(1)(c)(i) of this regulation shall be completed before the submission of each application for renewal.</text> </paragraph> <paragraph num="E."> <text>If an applicant for the renewal of a Class I or Class II permit returns a renewal application to the Board at least 90 days before the expiration of the permit, and the Board is unable to approve or deny the application before the expiration of the permit through no fault of the applicant, the permit shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the permit; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the permit.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Failure to receive the Board's renewal application does not relieve the permit holder from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the permit.</text> </paragraph> <paragraph num="G."> <text>The Board may issue a renewal of a Class I or Class II permit to an applicant for a specific practice location after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's renewal application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints that may affect the applicant's ability to safely and effectively administer anesthesia and sedation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Renewal of Class III Permits."> <paragraph num="A."> <text>The Board shall mail a renewal application to each individual holding a Class III permit at least 180 days before the expiration of the permit.</text> </paragraph> <paragraph num="B."> <text>Before a permit expires, an applicant may apply to renew the permit for an additional 5-year term if the applicant:</text> <paragraph num="(1)"> <text>Submits to the Board, at least 90 days before the expiration of the permit, a renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Passes a renewal evaluation in each facility for which the applicant wishes to renew a permit;</text> </paragraph> <paragraph num="(3)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20;</text> </paragraph> <paragraph num="(4)"> <text>Provides an affidavit to the Board indicating whether the applicant, since the issuance of the original permit or renewal, whichever is later, has treated a patient under deep sedation or general anesthesia with an incident requiring admission to a hospital either for a period greater than 24 hours, or for purposes other than observation;</text> </paragraph> <paragraph num="(5)"> <text>Provides evidence satisfactory to the Board that the applicant meets the continuing education requirements outlined in Regulation .29 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Submits any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An affidavit provided to the Board under §B(4) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="D."> <text>The renewal evaluation outlined in §B(2) of this regulation shall consist of an evaluation of an administration evaluation that consists of an office inspection and clinical evaluation.</text> </paragraph> <paragraph num="E."> <text>The clinical evaluation required by §D of this regulation shall:</text> <paragraph num="(1)"> <text>Require the participation of the clinical office staff; and</text> </paragraph> <paragraph num="(2)"> <text>Evaluate the technical competency of the dentist to:</text> <paragraph num="(a)"> <text>Safely administer general anesthesia, deep sedation, and moderate parenteral sedation; and</text> </paragraph> <paragraph num="(b)"> <text>Effectively respond to simulated anesthesia related emergencies with the participation of the clinical office staff trained to handle emergencies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The clinical evaluation outlined in §E of this regulation shall include evaluating the treatment of at least the following:</text> <paragraph num="(1)"> <text>Laryngospasm;</text> </paragraph> <paragraph num="(2)"> <text>Foreign body airway obstruction;</text> </paragraph> <paragraph num="(3)"> <text>Emergency airway management;</text> </paragraph> <paragraph num="(4)"> <text>Emesis and aspiration;</text> </paragraph> <paragraph num="(5)"> <text>Acute allergic reaction;</text> </paragraph> <paragraph num="(6)"> <text>Asthmatic attack;</text> </paragraph> <paragraph num="(7)"> <text>Bronchospasm;</text> </paragraph> <paragraph num="(8)"> <text>Angina;</text> </paragraph> <paragraph num="(9)"> <text>Conditions requiring advanced cardiac life support, including:</text> <paragraph num="(a)"> <text>Bradycardia;</text> </paragraph> <paragraph num="(b)"> <text>Tachycardia;</text> </paragraph> <paragraph num="(c)"> <text>Ventricular fibrillation; and</text> </paragraph> <paragraph num="(d)"> <text>Cardiac arrest;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Hypotension;</text> </paragraph> <paragraph num="(11)"> <text>Hypoglycemia;</text> </paragraph> <paragraph num="(12)"> <text>Hypertension;</text> </paragraph> <paragraph num="(13)"> <text>Seizure; and</text> </paragraph> <paragraph num="(14)"> <text>Syncope.</text> </paragraph> </paragraph> <paragraph num="G."> <text>In addition to the requirements of §D of this regulation, a dentist who wishes to renew a Class III permit shall pass a facility evaluation of facility equipment, medications, and clinical records to include at least the following:</text> <paragraph num="(1)"> <text>Oxygen and gas delivery system, backup system, back-up system fail-safe;</text> </paragraph> <paragraph num="(2)"> <text>Gas storage facility;</text> </paragraph> <paragraph num="(3)"> <text>Safety indexed gas system;</text> </paragraph> <paragraph num="(4)"> <text>Suction and backup system;</text> </paragraph> <paragraph num="(5)"> <text>Auxiliary lighting system;</text> </paragraph> <paragraph num="(6)"> <text>Suitability of operating room:</text> <paragraph num="(a)"> <text>Size;</text> </paragraph> <paragraph num="(b)"> <text>Lighting;</text> </paragraph> <paragraph num="(c)"> <text>Communications; and</text> </paragraph> <paragraph num="(d)"> <text>EMT accessibility;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Recovery area, including oxygen, suction, and visual and electronic monitoring, which may include the operating room;</text> </paragraph> <paragraph num="(8)"> <text>Appropriate emergency drugs;</text> </paragraph> <paragraph num="(9)"> <text>Nonexpired drugs;</text> </paragraph> <paragraph num="(10)"> <text>Appropriate devices to maintain an airway with positive pressure ventilation;</text> </paragraph> <paragraph num="(11)"> <text>Preoperative medical history and physical evaluation form;</text> </paragraph> <paragraph num="(12)"> <text>Anesthesia records, including monitoring and discharge records;</text> </paragraph> <paragraph num="(13)"> <text>Monitoring equipment, including pulse oximeter and blood pressure monitoring;</text> </paragraph> <paragraph num="(14)"> <text>Electrocardiogram (EKG);</text> </paragraph> <paragraph num="(15)"> <text>Anesthesia and monitoring equipment to ensure that they are in proper working order;</text> </paragraph> <paragraph num="(16)"> <text>Defibrillator or automated external defibrillator (AED);</text> </paragraph> <paragraph num="(17)"> <text>Capnograph measuring device; and</text> </paragraph> <paragraph num="(18)"> <text>In addition to the requirements of this section, for deep sedation or general anesthesia in pediatric patients a dentist shall have a pulse oximeter and either a:</text> <paragraph num="(a)"> <text>Precordial stethoscope; or</text> </paragraph> <paragraph num="(b)"> <text>Pretracheal stethoscope.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>The applicant and the applicant’s staff shall be present in the operatory during the evaluation.</text> </paragraph> <paragraph num="I."> <text>If an applicant for the renewal of a Class III permit returns a renewal application to the Board at least 90 days before the expiration of the permit, and the Board is unable to approve or deny the application before the expiration of the permit through no fault of the applicant, the permit shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the permit; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the permit.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Failure to receive the Board's renewal application does not relieve the permit holder from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the permit.</text> </paragraph> <paragraph num="K."> <text>The Board may issue a renewal of a Class III permit to an applicant for a specific practice location after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's renewal application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The renewal evaluation; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints that may affect the applicant's ability to safely and effectively administer anesthesia and sedation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Class III Dental School Facility Permit."> <paragraph num="A."> <text>After January 4, 2010, a dentist may not administer anesthesia or sedation for the practice of dentistry in a dental school recognized by the Commission on Dental Accreditation or its successor organization unless the dental school holds a Class III dental school facility permit.</text> </paragraph> <paragraph num="B."> <text>A dental school that applies for a Class III dental school facility permit shall pass an on-site facility evaluation by the Board or its designee as specified in Regulation .11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Issuance and Expiration of Class III Dental School Facility Permits."> <paragraph num="A."> <text>To obtain a dental school Class III facility permit a dental school recognized by the Commission on Dental Accreditation or its successor organization shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the fee set by the Board in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(3)"> <text>Provide evidence satisfactory to the Board that the dental school meets the qualifications for a Class III dental school facility permit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A Class III dental school facility permit shall expire on April 1 of the 5th year following the effective date of the permit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Renewal of Class III Dental School Facility Permits."> <paragraph num="A."> <text>The Board shall mail a renewal application to each dental school holding a Class III dental school facility permit at least 180 days before the expiration of the permit.</text> </paragraph> <paragraph num="B."> <text>Before a Class III dental school facility permit expires, the dental school may renew the permit for an additional 5-year term if the dental school:</text> <paragraph num="(1)"> <text>Submits to the Board, at least 90 days before the expiration of the permit, a renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Passes a renewal facility evaluation in each facility for which the dental school wishes to renew a permit; and</text> </paragraph> <paragraph num="(3)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The renewal evaluation outlined in §B(2) of this regulation shall consist of an evaluation of:</text> <paragraph num="(1)"> <text>Anesthesia and monitoring equipment to ensure they are in proper working order; and</text> </paragraph> <paragraph num="(2)"> <text>Drugs in the facility to ensure that the dental school:</text> <paragraph num="(a)"> <text>Maintains the appropriate drugs on the premises; and</text> </paragraph> <paragraph num="(b)"> <text>Only utilizes drugs on the premises the dates of which have not expired.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If a dental school returns a renewal application for a Class III dental school facility permit to the Board at least 90 days before the expiration of the permit, and the Board is unable to approve or deny the application before the expiration of the permit through no fault of the dental school, the permit shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the permit; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the permit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to receive the Board's renewal application does not relieve the dental school from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the permit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Dental School's Required Notice to Board."> <paragraph num="A."> <text>A dental school that holds a Class III Dental School Facility Permit shall advise the Board of any additional locations it has opened since the issuance or the renewal of its original permit.</text> </paragraph> <paragraph num="B."> <text>The notice required under §A of this regulation shall be provided to the Board in writing not later than 30 days before the opening of the additional location.</text> </paragraph> <paragraph num="C."> <text>A dentist may not administer anesthesia or sedation for the practice of dentistry in an additional location unless the school holds a Class III dental school facility permit for the additional location.</text> </paragraph> <paragraph num="D."> <text>A dental school that applies for a Class III dental school facility permit for an additional location shall pass an on-site facility evaluation by the Board or its designee as contained in Regulation .11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Facility Records."> <text>All facilities including a dental school that holds a Class III dental school facility permit shall maintain for 5 years for inspection by the Board:</text> <paragraph num="A."> <text>The name of each dentist who has administered anesthesia or sedation; and</text> </paragraph> <paragraph num="B."> <text>The license number of each dentist who has administered anesthesia or sedation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Unannounced Inspection Visits."> <paragraph num="A."> <text>During reasonable business hours, the Board or its designee may conduct unannounced inspection visits of any dental office or facility if the Board has:</text> <paragraph num="(1)"> <text>Received a complaint or has initiated a complaint; and</text> </paragraph> <paragraph num="(2)"> <text>Reason to believe that anesthesia or sedation has been administered:</text> <paragraph num="(a)"> <text>Without an appropriate permit; or</text> </paragraph> <paragraph num="(b)"> <text>In violation of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dentists and all associated personnel shall cooperate with the inspectors. Within 30 days of the conclusion of the inspection, the inspectors shall make reasonable efforts to submit a written report of the inspection to:</text> <paragraph num="(1)"> <text>The Board; and</text> </paragraph> <paragraph num="(2)"> <text>Each dentist and individual who was the subject of the inspection.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Facility Owner or Operator."> <paragraph num="A."> <text>The owner or operator of a facility may not permit an individual to administer anesthesia or sedation unless the individual is qualified to do so under this chapter.</text> </paragraph> <paragraph num="B."> <text>The owner or operator of a facility shall ensure that the facility:</text> <paragraph num="(1)"> <text>Remains properly equipped in accordance with Regulation .11A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Remains properly staffed in accordance with Regulation .14 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements contained in §B of this regulation, the owner or operator of a facility shall ensure that the facility has:</text> <paragraph num="(1)"> <text>Appropriate nonexpired emergency drugs; and</text> </paragraph> <paragraph num="(2)"> <text>Appropriate nonexpired drugs.</text> </paragraph> </paragraph> <paragraph num="D."> <text>After an opportunity for a hearing, the Board may take disciplinary action against a dentist under Health Occupations Article, §4-315(a) or (b), Annotated Code of Maryland, if the Board finds that:</text> <paragraph num="(1)"> <text>The dentist violates any provisions of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>The facility is inadequate under the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Failure to comply with this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Continuing Education Requirements for Renewal of a Permit."> <paragraph num="A."> <text>Renewal of a Class I, Class II, or Class III Permit. Beginning in 2016 and thereafter, an applicant who seeks renewal of a Class I, Class II, or Class III permit shall:</text> <paragraph num="(1)"> <text>Complete not less than 24 hours of clinical continuing education related to sedation or anesthesia in a classroom setting during the 5-year term of the permit; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain cardiopulmonary resuscitation certification from one of the following programs:</text> <paragraph num="(a)"> <text>The American Heart Association's Basic Life Support for Healthcare Providers;</text> </paragraph> <paragraph num="(b)"> <text>The American Red Cross's Cardiopulmonary Resuscitation for Professional Rescuers;</text> </paragraph> <paragraph num="(c)"> <text>The American Safety & Health Institute; or</text> </paragraph> <paragraph num="(d)"> <text>An equivalent program approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Requirements for Renewal of a Class I Permit.</text> <paragraph num="(1)"> <text>In addition to the requirements outlined in §A of this regulation, an applicant for the renewal of a Class I permit shall:</text> <paragraph num="(a)"> <text>Complete a Board-approved course of at least 4 hours that provides instruction on medical emergencies and airway management;</text> </paragraph> <paragraph num="(b)"> <text>Maintain Advanced Cardiac Life Support (ACLS) certification; or</text> </paragraph> <paragraph num="(c)"> <text>Maintain Pediatric Advanced Life support certification (PALS).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following courses may count toward the required hours of continuing education:</text> <paragraph num="(a)"> <text>Advanced Cardiac Life Support (ACLS) course;</text> </paragraph> <paragraph num="(b)"> <text>Pediatric Advanced Life Support (PALS) course; or</text> </paragraph> <paragraph num="(c)"> <text>A Board-approved course in medical emergency and airway management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Additional Requirements for Renewal of a Class II or Class III Permit.</text> <paragraph num="(1)"> <text>In addition to the requirements outlined in §A of this regulation, an applicant for the renewal of a Class II or Class III permit shall:</text> <paragraph num="(a)"> <text>Complete a Board-approved course of at least 4 hours that provides instruction on medical emergencies and airway management;</text> </paragraph> <paragraph num="(b)"> <text>Maintain Advanced Cardiac Life Support (ACLS) certification; or</text> </paragraph> <paragraph num="(c)"> <text>Maintain Pediatric Advanced Life Support (PALS) certification.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following courses may count toward the required hours of continuing education:</text> <paragraph num="(a)"> <text>Advanced Cardiac Life Support (ACLS) course;</text> </paragraph> <paragraph num="(b)"> <text>Pediatric Advanced Life Support (PALS) course; or</text> </paragraph> <paragraph num="(c)"> <text>A Board-approved course in medical emergency and airway management.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Transfer of Permits Prohibited."> <text>A Class I, Class II, or Class III permit may not be transferred to another person or location.</text> </regulation> <regulation prefix="Regulation" num=".31" heading="Administration by Physicians or Dentists at the Site of a Treating Dentist."> <paragraph num="A."> <text>A treating dentist who wishes to allow a physician or another dentist to administer anesthesia and sedation to a patient at a specific practice location shall receive a certificate from the Board before allowing a physician or another dentist to administer anesthesia and sedation at that location.</text> </paragraph> <paragraph num="B."> <text>To apply for a certificate to allow a physician or another dentist to administer anesthesia and sedation:</text> <paragraph num="(1)"> <text>A treating dentist shall:</text> <paragraph num="(a)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Possess either a Class I, Class II, or Class III permit;</text> </paragraph> <paragraph num="(c)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(d)"> <text>Submit any other pertinent documents or information requested by the Board; and</text> </paragraph> <paragraph num="(e)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A treating dentist shall:</text> <paragraph num="(a)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Provide documentation to the Board that the treating dentist has completed a Board-approved training program where the treating dentist received competent training in treating patients under:</text> <paragraph num="(i)"> <text>Moderate enteral sedation and airway management;</text> </paragraph> <paragraph num="(ii)"> <text>Moderate parenteral sedation and airway management;</text> </paragraph> <paragraph num="(iii)"> <text>Deep sedation and airway management; or</text> </paragraph> <paragraph num="(iv)"> <text>General anesthesia and airway management;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(d)"> <text>Submit any other pertinent documents or information requested by the Board; and</text> </paragraph> <paragraph num="(e)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An affidavit provided to the Board under §B(1)(c) or (2)(c) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="D."> <text>In addition to the requirements contained in §§A—C of this regulation, a treating dentist who applies for a certificate to allow a physician or another dentist to administer anesthesia and sedation to a patient shall:</text> <paragraph num="(1)"> <text>Maintain either a Class I, Class II, or Class III permit for the administration site; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain facility equipment in the facility consistent with a Class III permit as outlined in Regulation .11A of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may issue a certificate to a dentist to allow a physician or another dentist to administer anesthesia and sedation after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The applicant's patient records; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information including, but not limited to, patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A certificate issued to a treating dentist to allow a physician or another dentist to administer anesthesia and sedation at a specific location shall expire on April 1 of the 5th year following the effective date of the certificate.</text> </paragraph> <paragraph num="G."> <text>A dentist who administers anesthesia or sedation pursuant to §A of this regulation shall maintain the appropriate permit for the administration site.</text> </paragraph> <paragraph num="H."> <text>A dentist who holds a certificate to allow a physician or another dentist to administer anesthesia or sedation shall be present in the operatory during the administration of the anesthesia or sedation.</text> </paragraph> <paragraph num="I."> <text>Renewal. The Board shall mail a renewal application to each treating dentist who has received a certificate from the Board to allow a physician or another dentist to administer anesthesia and sedation at least 180 days before the expiration of the certificate.</text> </paragraph> <paragraph num="J."> <text>Before the certificate expires, an applicant may apply to renew the certificate for an additional 5-year term if the applicant submits to the Board at least 90 days before the expiration of the certificate:</text> <paragraph num="(1)"> <text>A renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>An affidavit indicating whether the applicant, since the issuance of the original certificate or renewal, whichever is later, has treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(3)"> <text>A nonrefundable fee as set forth in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An affidavit provided to the Board under §J(2) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="L."> <text>The Board may issue a renewal certificate to a dentist to allow a physician or another dentist to administer anesthesia and sedation after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information including but not limited to patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="M."> <text>If an applicant for the renewal of a certificate to allow a physician or another dentist to administer anesthesia and sedation returns a renewal application to the Board at least 90 days before the expiration of the certificate, and the Board is unable to approve or deny the application before the expiration of the certificate through no fault of the applicant, the certificate shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the certificate; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the certificate.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Failure to receive the Board's renewal application does not relieve the certificate holder from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".32" heading="Certification of a Dentist Providing Treatment Outside the Dentist's Location."> <paragraph num="A."> <text>A treating dentist who treats a patient at a practice location other than the dentist's own location, at which anesthesia and sedation are administered to the patient, shall receive a certificate from the Board before treating the patient.</text> </paragraph> <paragraph num="B."> <text>To apply for a certificate to treat a patient at a practice location other than the dentist's own location, at which anesthesia and sedation are administered to the patient:</text> <paragraph num="(1)"> <text>A treating dentist shall:</text> <paragraph num="(a)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Possess a Class I, Class II, or Class III permit;</text> </paragraph> <paragraph num="(c)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(d)"> <text>Submit any other pertinent documents or information requested by the Board; and</text> </paragraph> <paragraph num="(e)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A treating dentist shall:</text> <paragraph num="(a)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Provide documentation to the Board that the treating dentist has completed a Board-approved training program where the treating dentist received competent training in treating patients under:</text> <paragraph num="(i)"> <text>Moderate enteral sedation and airway management;</text> </paragraph> <paragraph num="(ii)"> <text>Moderate parenteral sedation and airway management;</text> </paragraph> <paragraph num="(iii)"> <text>Deep sedation and airway management; or</text> </paragraph> <paragraph num="(iv)"> <text>General anesthesia and airway management;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(d)"> <text>Submit any other pertinent documents or information requested by the Board; and</text> </paragraph> <paragraph num="(e)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An affidavit provided to the Board under §B(1)(c) or (2)(c) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="D."> <text>In addition to the requirements contained in §§A—C of this regulation, a treating dentist who applies for a certificate shall maintain a Class I, Class II, or Class III permit for an administration site in the State.</text> </paragraph> <paragraph num="E."> <text>The Board may issue a certificate after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The applicant's patient records; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A certificate issued under this regulation is not specific to a particular practice location.</text> </paragraph> <paragraph num="G."> <text>A certificate expires on April 1 of the 5th year following the effective date of the certificate.</text> </paragraph> <paragraph num="H."> <text>A dentist who administers anesthesia or sedation pursuant to this regulation shall maintain the appropriate permit for the administration site.</text> </paragraph> <paragraph num="I."> <text>A treating dentist who holds a certificate to treat a patient at a practice location other than the dentist’s own location, at which anesthesia or sedation are administered to the patient, shall be present in the operatory during the administration of the anesthesia or sedation.</text> </paragraph> <paragraph num="J."> <text>Renewal. The Board shall mail a renewal application to each treating dentist who has received a certificate from the Board at least 180 days before the expiration of the certificate.</text> </paragraph> <paragraph num="K."> <text>Before the certificate expires, an applicant may apply to renew the certificate for an additional 5-year term if the applicant submits to the Board at least 90 days before the expiration of the certificate:</text> <paragraph num="(1)"> <text>A renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>An affidavit indicating whether the applicant, since the issuance of the original certificate or renewal, whichever is later, has treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(3)"> <text>A nonrefundable fee as set forth in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="L."> <text>An affidavit provided to the Board under §K(2) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="M."> <text>The Board may issue a renewal certificate to a dentist after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="N."> <text>If an applicant for the renewal of a certificate returns a renewal application to the Board at least 90 days before the expiration of the certificate, and the Board is unable to approve or deny the application before the expiration of the certificate through no fault of the applicant, the certificate shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the certificate; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the certificate.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Failure to receive the Board's renewal application does not relieve the certificate holder from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".33" heading="Administration by a Certified Registered Nurse Anesthetist."> <paragraph num="A."> <text>A treating dentist who wishes to allow a certified registered nurse anesthetist to administer anesthesia and sedation to a patient at a specific practice location shall receive a certificate from the Board before allowing a certified registered nurse anesthetist to administer anesthesia and sedation at that location.</text> </paragraph> <paragraph num="B."> <text>To apply for a certificate to allow a certified registered nurse anesthetist to administer anesthesia and sedation, a treating dentist shall:</text> <paragraph num="(1)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Provide an affidavit to the Board indicating whether the treating dentist has ever treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(3)"> <text>Submit any other pertinent documents or information requested by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An affidavit provided to the Board under §B(2) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="D."> <text>In addition to the requirements in §§A—C of this regulation, a treating dentist who applies for a certificate to allow a certified registered nurse anesthetist to administer anesthesia and sedation to a patient shall maintain permits as follows:</text> <paragraph num="(1)"> <text>A treating dentist who allows a certified registered nurse anesthetist to administer moderate enteral sedation to a patient shall maintain a Class I permit for the administration site;</text> </paragraph> <paragraph num="(2)"> <text>A treating dentist who allows a certified registered nurse anesthetist to administer moderate parenteral sedation to a patient shall maintain a Class II permit for the administration site; and</text> </paragraph> <paragraph num="(3)"> <text>A treating dentist who allows a certified registered nurse anesthetist to administer deep sedation or general anesthesia to a patient shall maintain a Class III permit for the administration site.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the requirements of this regulation, a dentist who allows a certified registered nurse anesthetist to administer anesthesia and sedation shall maintain facility equipment in the facility consistent with a Class III permit as outlined in Regulation .11A of this chapter.</text> </paragraph> <paragraph num="F."> <text>A treating dentist who holds a certificate to allow a certified registered nurse anesthetist to administer anesthesia or sedation shall be present in the operatory during the administration of the anesthesia or sedation.</text> </paragraph> <paragraph num="G."> <text>The Board may issue a certificate to a dentist to allow a certified registered nurse anesthetist to administer anesthesia and sedation after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications;</text> </paragraph> <paragraph num="(3)"> <text>The applicant's patient records; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A certificate issued to a treating dentist to allow a certified registered nurse anesthetist to administer anesthesia and sedation at a specific location expires on April 1 of the 5th year following the effective date of the certificate.</text> </paragraph> <paragraph num="I."> <text>Renewal. The Board shall mail a renewal application to each treating dentist who has received a certificate from the Board to allow a certified registered nurse anesthetist to administer anesthesia and sedation at least 180 days before the expiration of the certificate.</text> </paragraph> <paragraph num="J."> <text>Before the certificate expires, an applicant may apply to renew the certificate for an additional 5-year term if the applicant submits to the Board at least 90 days before the expiration of the certificate:</text> <paragraph num="(1)"> <text>A renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>An affidavit indicating whether the applicant, since the issuance of the original certificate or renewal, whichever is later, has treated a patient under deep sedation or general anesthesia with an incident;</text> </paragraph> <paragraph num="(3)"> <text>A nonrefundable fee as set forth in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(4)"> <text>Any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An affidavit provided to the Board under §J(2) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in Regulation .08G of this chapter.</text> </paragraph> <paragraph num="L."> <text>The Board may issue a renewal certificate to a dentist to allow a certified registered nurse anesthetist to administer anesthesia and sedation after the Board's review of:</text> <paragraph num="(1)"> <text>The applicant's application and accompanying affidavit;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's qualifications; and</text> </paragraph> <paragraph num="(3)"> <text>Any other pertinent documents or information, including, but not limited to, patient complaints which may affect the applicant's ability to safely and effectively treat patients under anesthesia and sedation.</text> </paragraph> </paragraph> <paragraph num="M."> <text>If an applicant for the renewal of a certificate to allow a certified registered nurse anesthetist to administer anesthesia and sedation returns a renewal application to the Board at least 90 days before the expiration of the certificate, and the Board is unable to approve or deny the application before the expiration of the certificate through no fault of the applicant, the certificate shall remain in effect until the Board:</text> <paragraph num="(1)"> <text>Renews the certificate; or</text> </paragraph> <paragraph num="(2)"> <text>Denies renewal of the certificate.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Failure to receive the Board's renewal application does not relieve the certificate holder from the requirement to submit a renewal application to the Board at least 90 days before the expiration of the certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".34" heading="Display and Location of Permit."> <paragraph num="A."> <text>A dentist who holds a Class I, Class II, or Class III permit shall maintain their wallet certificate in their possession for inspection at the administration site.</text> </paragraph> <paragraph num="B."> <text>A dentist who holds a general anesthesia facility permit or a parenteral sedation facility permit shall display the permit and any current renewal certificates in the facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".35" heading="Exceptions to Anesthesia and Sedation Permits and Dentist Certification."> <text>A dentist who treats a patient at an accredited facility as defined in Regulation .03 of this chapter where anesthesia or sedation is being administered to the patient by either another dentist, physician, or certified registered nurse anesthetist is not required to hold:</text> <paragraph num="A."> <text>A Class I, Class II, or Class III permit; or</text> </paragraph> <paragraph num="B."> <text>A certification to allow another dentist, physician, or certified registered nurse anesthetist to administer anesthesia or sedation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".36" heading="Morbidity and Mortality Reports."> <paragraph num="A."> <text>A dentist shall report to the Board, in writing, any death caused by or resulting from the dentist's administration of anxiolysis, moderate sedation, deep sedation, or general anesthesia within 7 days after its occurrence.</text> </paragraph> <paragraph num="B."> <text>A dentist shall report to the Board, in writing, any complication or disabling incident requiring admission to a hospital either for a period greater than 24 hours, or for purposes other than observation, as a result of the dentist’s administration of anxiolysis, moderate sedation, deep sedation, or general anesthesia within 15 days after its occurrence.</text> </paragraph> <paragraph num="C."> <text>The written report to the Board required in §§A and B of this regulation shall include:</text> <paragraph num="(1)"> <text>The date of the incident;</text> </paragraph> <paragraph num="(2)"> <text>The name, age, and address of the patient;</text> </paragraph> <paragraph num="(3)"> <text>The patient's original complete dental records;</text> </paragraph> <paragraph num="(4)"> <text>The name and license number of the licensee and the name and address of all other persons present during the incident;</text> </paragraph> <paragraph num="(5)"> <text>The address where the incident took place;</text> </paragraph> <paragraph num="(6)"> <text>The preoperative physical condition of the patient;</text> </paragraph> <paragraph num="(7)"> <text>The type of anesthesia and dosages of drugs administered to the patient;</text> </paragraph> <paragraph num="(8)"> <text>The techniques used in administering the drugs;</text> </paragraph> <paragraph num="(9)"> <text>Any adverse occurrence including:</text> <paragraph num="(a)"> <text>The patient's signs and symptoms;</text> </paragraph> <paragraph num="(b)"> <text>The treatment instituted in response to adverse occurrences;</text> </paragraph> <paragraph num="(c)"> <text>The patient's response to the treatment; and</text> </paragraph> <paragraph num="(d)"> <text>The patient's condition on termination of any procedures undertaken; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A narrative description of the incident including approximate times and evolution of symptoms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The duties outlined in §§A—C of this regulation apply to every dentist whether or not the dentist holds a permit.</text> </paragraph> <paragraph num="E."> <text>The Board may initiate a complaint based upon the contents of a morbidity or mortality report.</text> </paragraph> <paragraph num="F."> <text>A Board initiated complaint under §E of this regulation shall be independent of and may not prejudice the filing of a complaint by a third party.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".37" heading="Violations for Individuals with a Class I, Class II, or Class III Permit."> <paragraph num="A."> <text>After an opportunity for a hearing, the Board may revoke or suspend a Class I, Class II, or Class III permit or take disciplinary action under Health Occupations Article, §4-315(a) or (b), Annotated Code of Maryland, if the Board finds that:</text> <paragraph num="(1)"> <text>The holder of the permit violates any provision of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>The facility is inadequate under the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to comply with this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".38" heading="Violations for Individuals with General Anesthesia and Parenteral Sedation Permits in Existence as of January 4, 2010."> <paragraph num="A."> <text>After an opportunity for a hearing, the Board may revoke or suspend a general anesthesia administration permit or a parenteral sedation administration permit or take disciplinary action under Health Occupations Article, §4-315(a) or (b), Annotated Code of Maryland, if the Board finds that:</text> <paragraph num="(1)"> <text>The holder of the permit violates Regulation .13, .14, .26, .31, .32, .33, or .36 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>The facility is inadequate under the provisions of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to comply with the applicable provisions of this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".39" heading="Summary Suspension of a Permit."> <paragraph num="A."> <text>The Board may order the summary suspension of a permit if the Board:</text> <paragraph num="(1)"> <text>Finds that the public health, safety, or welfare imperatively requires emergency action; and</text> </paragraph> <paragraph num="(2)"> <text>Promptly gives the licensee:</text> <paragraph num="(a)"> <text>Written notice of the suspension, the finding, and the reasons that support the finding; and</text> </paragraph> <paragraph num="(b)"> <text>An opportunity to be heard.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Service of the notice of the suspension, the finding, the reasons that support the finding, and the notice of the opportunity to be heard may be effected upon the holder of a permit by:</text> <paragraph num="(1)"> <text>Personal service; or</text> </paragraph> <paragraph num="(2)"> <text>Written notice sent by certified mail and regular mail to the permit holder's address on file with the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Service made pursuant to §B(2) of this regulation shall be effective upon mailing.</text> </paragraph> <paragraph num="D."> <text>The methods of service provided in this regulation are in addition to and not exclusive of any other means of service that are reasonably calculated to provide notice.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 11, 1985 (12:3 Md. 245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 8, 1999 (26:5 Md. R. 392)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective September 23, 1996 (23:19 Md. R. 1376)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 19, 1990 (17:3 Md. R. 300); March 8, 1999 (26:5 Md. R. 392)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective September 23, 1996 (23:19 Md. R. 1376); March 8, 1999 (26:5 Md. R. 392)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13 under General Anesthesia, repealed, and new Regulations .01—.37 under Anesthesia and Sedation, adopted effective January 4, 2010 (36:18 Md. R. 1380)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 11, 2015 (42:9 Md. R. 648)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21G amended effective December 30, 2019 (46:26 Md. R. 1165)</annotation> </annotations> </chapter> <chapter num="13" heading="Radiographic Protection"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern all licensed dentists, licensed dental hygienists, dental assistants, dental students, dental hygiene students, and dental assistant students.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="“Protection” Defined."> <text>For purposes of these regulations, “protection” means the lead shielding of 0.25 millimeter lead equivalence or greater.</text> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Incorporation by Reference."> <text>Dental X-Ray Protection, NCRP Report No. 35 (National Council on Radiation Protection and Measurements, Issued March 9, 1970), is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Circumstances for Protection."> <text>Protection shall be placed over the patient in accordance with Dental X-Ray Protection, NCRP Report No. 35.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Exceptions."> <text>Protection is not required if its use would interfere with the diagnostic quality of the resultant radiographs.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties for Violation."> <text>A violation of these regulations during the exposure of dental radiographs constitutes unprofessional conduct.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-506, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 14, 1985 (12:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective October 16, 2000 (27:20 Md. R. 1839)</annotation> </annotations> </chapter> <chapter num="14" heading="Approved Specialty Fields and Qualifications for Identification as a Specialist"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the qualifications for identification of a licensed dentist as a specialist by the Maryland State Board of Dental Examiners, and the application procedures and fees for the identification.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definition."> <text>For purposes of this chapter, “Board” means the Maryland State Board of Dental Examiners.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Designation of Specialties."> <text>The Board recognizes the following areas of dentistry as specialties:</text> <paragraph num="A."> <text>Endodontics;</text> </paragraph> <paragraph num="B."> <text>Oral surgery, also known as oral and maxillofacial surgery;</text> </paragraph> <paragraph num="C."> <text>Oral pathology;</text> </paragraph> <paragraph num="D."> <text>Orthodontics;</text> </paragraph> <paragraph num="E."> <text>Pediatric dentistry;</text> </paragraph> <paragraph num="F."> <text>Periodontics;</text> </paragraph> <paragraph num="G."> <text>Prosthodontics;</text> </paragraph> <paragraph num="H."> <text>Public health; and</text> </paragraph> <paragraph num="I."> <text>Any area of specialty approved by the Commission on Dental Accreditation or its successor organization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications for Identification."> <text>A licensed dentist qualifies for identification as specialist by the Board if the dentist:</text> <paragraph num="A."> <text>Has successfully completed a Board-approved specialty training program in that specialty; or</text> </paragraph> <paragraph num="B."> <text>Before July 1, 1979, reasonably represented to the public that the dentist was a specialist in that specialty while limiting the dentist's practice to the specialty.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application for Identification."> <text>To apply for identification as a specialist, a licensed dentist shall submit to the Board:</text> <paragraph num="A."> <text>An application on a form that the Board provides;</text> </paragraph> <paragraph num="B."> <text>A fee as set forth in COMAR 10.44.20; and</text> </paragraph> <paragraph num="C."> <text>Either evidence of having successfully completed a Board-approved specialty training program or a written statement, under oath, that sets forth the basis for the dentist's claim that, before July 1, 1979, the dentist reasonably represented to the public that the dentist was a specialist in that specialty, including in that written statement the:</text> <paragraph num="(1)"> <text>Dates during which the dentist's practice was limited to that specialty; and</text> </paragraph> <paragraph num="(2)"> <text>Education and experience on which the claim to be a specialist was based.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Roster of Specialists."> <text>The Board shall maintain a roster of all licensed dentists identified as specialists in each of the specialties recognized by the Board.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="List of Approved Programs."> <text>The Board shall maintain a list of all specialty training programs it approves. The list shall be open to the public during the normal business hours of the Board.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Prohibition."> <paragraph num="A."> <text>On or after July 1, 1985, a person may not represent to the public that the person is a dentist specializing in any specialty of dentistry or limiting the dentist's practice of dentistry to any specialty of dentistry unless the person is recognized by the Board as a specialist in that specialty.</text> </paragraph> <paragraph num="B."> <text>A person may not represent to the public that the person is a specialist in any area not approved by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Penalties for Violation."> <text>Violation of these regulations constitutes unprofessional conduct and may result in disciplinary action as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-504, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 28, 1985 (12:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 26, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective August 20, 1990 (17:16 Md. R. 1991)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective November 20, 1994 (21:23 Md. R. 1954)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective August 20, 1990 (17:16 Md. R. 1991)</annotation> </annotations> </chapter> <chapter num="15" heading="Dentists and Dental Hygienists — Licensure by Examination"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs dentists and dental hygienists who seek a general license to practice dentistry or dental hygiene and who do not hold a license to practice dentistry or dental hygiene in another state.</text> </paragraph> <paragraph num="B."> <text>Licensure for dentists licensed in another state is governed by COMAR 10.44.05.</text> </paragraph> <paragraph num="C."> <text>Licensure for dental hygienists licensed in another state is governed by COMAR 10.44.09.</text> </paragraph> <paragraph num="D."> <text>General licensure for pediatric dental residents with a limited license at the University of Maryland Dental School who have successfully met all requirements for general licensure is governed by COMAR 10.44.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ADEX” means the American Board of Dental Examiners, Inc., or its successor organization.</text> </paragraph> <paragraph num="(2)"> <text>“ADHLEX” means the American Dental Hygiene Licensing Examination, which includes both a written component and a clinical component, designed and developed by ADEX, or its successor examination.</text> </paragraph> <paragraph num="(3)"> <text>“ADLEX” means the American Dental Licensing Examination, which includes both a written component and a clinical component, designed and developed by ADEX, or its successor examination.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Qualification Requirements."> <paragraph num="A."> <text>To qualify for a general license to practice dentistry an applicant shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be at least 18 years old; and</text> </paragraph> <paragraph num="(3)"> <text>Hold a degree of Doctor of Dental Surgery, Doctor of Dental Medicine, or the equivalent from a college or university that is:</text> <paragraph num="(a)"> <text>Authorized by any state or any province of Canada to grant the degree; and</text> </paragraph> <paragraph num="(b)"> <text>Recognized by the Board as:</text> <paragraph num="(i)"> <text>Requiring adequate preprofessional collegiate training; and</text> </paragraph> <paragraph num="(ii)"> <text>Maintaining an acceptable course of dental instruction.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements contained in §A of this regulation, an applicant for a dental license shall meet all the requirements for licensure contained in Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>To qualify for a general license to practice dental hygiene an applicant shall:</text> <paragraph num="(1)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(2)"> <text>Be a graduate of a school for dental hygienists that:</text> <paragraph num="(a)"> <text>Requires at least 2 years of education in an institution of higher education;</text> </paragraph> <paragraph num="(b)"> <text>Is accredited by the American Dental Association Commission on Dental Accreditation; and</text> </paragraph> <paragraph num="(c)"> <text>Is approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements contained in §C of this regulation, an applicant for a dental hygiene license shall meet all of the requirements for licensure contained in Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>An applicant who otherwise qualifies for an initial dental license shall pass the written and clinical ADLEX examination with a score of 75 or greater in each required section.</text> </paragraph> <paragraph num="F."> <text>An applicant who otherwise qualifies for an initial dental hygiene license shall pass the written and clinical ADHLEX examination with a score of 75 or greater in each required section.</text> </paragraph> <paragraph num="G."> <text>An applicant for an initial dental or dental hygiene license shall pass the national boards examinations, also known as the National Boards, administered by the Council of National Boards of the American Dental Association.</text> </paragraph> <paragraph num="H."> <text>An applicant who fails the ADLEX or ADHLEX examinations four times may not be licensed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Locations, Frequency, Content, and Grading of Examinations."> <text>The ADEX has the authority to determine:</text> <paragraph num="A."> <text>Examination sites;</text> </paragraph> <paragraph num="B."> <text>Frequency of examinations;</text> </paragraph> <paragraph num="C."> <text>Examination content; and</text> </paragraph> <paragraph num="D."> <text>Grading method, provided that the grading method is not arbitrary and capricious.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Completion of All Sections of Examinations Required."> <text>Applicants may not be licensed until they have successfully passed:</text> <paragraph num="A."> <text>All required sections of the ADLEX or ADHLEX examination; and</text> </paragraph> <paragraph num="B."> <text>The national board examinations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Maryland Law Examination."> <paragraph num="A."> <text>In addition to passing the ADLEX or ADHLEX examination and national board examinations, an applicant shall pass a written examination on laws, regulations, and ethics given by the Board or its designee.</text> </paragraph> <paragraph num="B."> <text>The examination shall consist of the following two parts:</text> <paragraph num="(1)"> <text>General questions on:</text> <paragraph num="(a)"> <text>Laws;</text> </paragraph> <paragraph num="(b)"> <text>Regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Ethics; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Questions on Maryland jurisprudence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant shall attain a score of 75 or greater on each section of the examination described in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Loss of Clinical Skills."> <text>The Board may require that an applicant for licensure successfully pass each required section of the ADLEX or ADHLEX clinical examination if the Board determines that the applicant may have lost clinical skills because of an extended absence from clinical practice.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Application and Fee."> <paragraph num="A."> <text>A candidate for licensure shall:</text> <paragraph num="(1)"> <text>Fully complete the appropriate Board application; and</text> </paragraph> <paragraph num="(2)"> <text>Pay the required fee in accordance with COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An application shall be returned to the applicant and the applicant may not be licensed if the application:</text> <paragraph num="(1)"> <text>Is incomplete;</text> </paragraph> <paragraph num="(2)"> <text>Does not contain all of the requested information or documentation; or</text> </paragraph> <paragraph num="(3)"> <text>Is not accompanied by the required fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall refund the application fee, less a $50 processing fee, to a dentist or a dental hygienist who does not qualify for licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Application Procedures for Dentists and Dental Hygienists."> <text>An applicant for a dental or a dental hygiene license shall submit the following to the Board:</text> <paragraph num="A."> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>A recent photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="C."> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="D."> <text>Certified proof of dental or dental hygiene education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature, do not require a raised embossed seal;</text> </paragraph> <paragraph num="E."> <text>A certified ADLEX or ADHLEX score;</text> </paragraph> <paragraph num="F."> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="G."> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-302, 4-303.1(d), 4-305, and 4-306, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 19, 1990 (17:3 Md. R. 300)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 5, 2004 (31:13 Md. R. 995)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed and new Regulations .01—.09 adopted as an emergency provision effective October 1, 2012 (39:22 Md. R. 1427); adopted permanently effective December 24, 2012 (39:25 Md. R. 1614)</annotation> </annotations> </chapter> <chapter num="16" heading="Petition for Declaratory Ruling"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the State Board of Dental Examiners and a petitioner for a declaratory ruling.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Person” means an individual, an agency, an association, a corporation, or any other entity.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Petition."> <paragraph num="A."> <text>An interested person may file with the Board a petition for a declaratory ruling with respect to the manner in which the Board would apply a statute, a regulation, or an order that the Board enforces to a particular case based on the facts presented in the petition.</text> </paragraph> <paragraph num="B."> <text>The petition for a declaratory ruling shall be filed in writing on a form provided by the Board.</text> </paragraph> <paragraph num="C."> <text>The petition shall contain a statement describing in detail the:</text> <paragraph num="(1)"> <text>Interest of the petitioner in making a request;</text> </paragraph> <paragraph num="(2)"> <text>Issue involved;</text> </paragraph> <paragraph num="(3)"> <text>Facts to be considered; and</text> </paragraph> <paragraph num="(4)"> <text>Documents or statements, or both, to be considered.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The petition shall contain a sworn statement by the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief.</text> </paragraph> <paragraph num="E."> <text>Within 60 days after receipt of the petition, the Board shall inform the petitioner whether the petition will be granted.</text> </paragraph> <paragraph num="F."> <text>If the petition is denied, the Board shall inform the petitioner in writing of the reasons for denial.</text> </paragraph> <paragraph num="G."> <text>If the petition is granted, the Board or its designee shall inform the petitioner of the date on which the Board will issue the declaratory ruling.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Consideration and Disposition."> <paragraph num="A."> <text>A petition will be granted unless the Board or its designee considers a declaratory ruling inadvisable due to considerations listed in §H of this regulation.</text> </paragraph> <paragraph num="B."> <text>In rendering its ruling, the Board or its designee:</text> <paragraph num="(1)"> <text>Shall consider all materials submitted with the petition;</text> </paragraph> <paragraph num="(2)"> <text>May consider any document, data, or other relevant material;</text> </paragraph> <paragraph num="(3)"> <text>May consult individuals;</text> </paragraph> <paragraph num="(4)"> <text>May consider comments from the staff; or</text> </paragraph> <paragraph num="(5)"> <text>May require argument of the question or permit the introduction of evidence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A declaratory ruling issued shall be in writing, stating the:</text> <paragraph num="(1)"> <text>Issue;</text> </paragraph> <paragraph num="(2)"> <text>Conclusion;</text> </paragraph> <paragraph num="(3)"> <text>Facts upon which the conclusion was based; and</text> </paragraph> <paragraph num="(4)"> <text>Sources relied upon.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A declaratory ruling issued by the Board shall plainly state that it is a declaratory ruling made pursuant to these regulations.</text> </paragraph> <paragraph num="E."> <text>A written answer from the Board or any employee of the Board to an inquiry may not be construed as a declaratory ruling unless made in conformity with these regulations.</text> </paragraph> <paragraph num="F."> <text>The Board shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to statute or regulation involved.</text> </paragraph> <paragraph num="G."> <text>The Board may publish declaratory rulings of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act.</text> </paragraph> <paragraph num="H."> <text>A petition may be denied if the:</text> <paragraph num="(1)"> <text>Request contains incomplete information upon which to base an informed declaratory ruling;</text> </paragraph> <paragraph num="(2)"> <text>Board or its designee concludes that a declaratory ruling cannot reasonably be given on the matter;</text> </paragraph> <paragraph num="(3)"> <text>Matter is adequately covered by a:</text> <paragraph num="(a)"> <text>Prior regulation,</text> </paragraph> <paragraph num="(b)"> <text>Declaratory ruling,</text> </paragraph> <paragraph num="(c)"> <text>Decision, or</text> </paragraph> <paragraph num="(d)"> <text>Legal opinion; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Board or its designee concludes that a ruling would not be in the public interest.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Effect, Revision, and Appeal."> <paragraph num="A."> <text>A declaratory ruling shall be binding upon the Board and the petitioner on the statement of facts covered in the declaratory ruling and set forth in the petition.</text> </paragraph> <paragraph num="B."> <text>A petitioner may apply for revision of a declaratory ruling.</text> </paragraph> <paragraph num="C."> <text>The petitioner's application for revision of the declaratory ruling shall:</text> <paragraph num="(1)"> <text>Be filed within 10 days after the issuance of the declaratory ruling;</text> </paragraph> <paragraph num="(2)"> <text>State the grounds for the revision; and</text> </paragraph> <paragraph num="(3)"> <text>Stay enforcement of the declaratory ruling until disposition.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon receipt of the application, the Board may:</text> <paragraph num="(1)"> <text>Reopen the declaratory ruling to receive additional information;</text> </paragraph> <paragraph num="(2)"> <text>Amend its ruling or its statement of reasons for the ruling;</text> </paragraph> <paragraph num="(3)"> <text>Set forth additional findings or reasons; and</text> </paragraph> <paragraph num="(4)"> <text>Enter new findings, new reasons, or a new ruling.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall grant or deny the application for revision within 45 days of its receipt.</text> </paragraph> <paragraph num="F."> <text>The Board may exercise revisory power and control over the declaratory ruling in the case of fraud, mistake, or irregularity.</text> </paragraph> <paragraph num="G."> <text>A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">State Government Article, §§10-304 and 10-305, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 19, 1990 (17:3 Md. R. 300)</annotation> </annotations> </chapter> <chapter num="17" heading="Temporary License to Practice Dental Hygiene"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations establish qualifications and requirements for applicants for a temporary license to practice dental hygiene in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility."> <text>An individual is eligible for a temporary license to practice dental hygiene if the individual:</text> <paragraph num="A."> <text>Is a graduate of a school for dental hygienists that requires at least 2 years of education in an institution of higher learning that is accredited by the American Dental Association Commission on Dental Accreditation and is approved by the Board;</text> </paragraph> <paragraph num="B."> <text>Is currently licensed to practice dental hygiene in any other state or any province of Canada; and</text> </paragraph> <paragraph num="C."> <text>Has practiced dental hygiene at least 800 hours per year for 2 years and has practiced dental hygiene during the past 2 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Procedures."> <text>An applicant shall submit to the Board:</text> <paragraph num="A."> <text>An application on the form that the Board requires for a temporary license;</text> </paragraph> <paragraph num="B."> <text>Proof of current licensure in another state or province of Canada;</text> </paragraph> <paragraph num="C."> <text>A statement from previous employers verifying the required practice experience;</text> </paragraph> <paragraph num="D."> <text>An application fee as specified in COMAR 10.44.20.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Jurisprudence Examination."> <text>Before a temporary license to practice dental hygiene is issued, the applicant shall pass a written examination administered by the Board, on the Maryland Dentistry Act, Health Occupations Article, Title 4, Annotated Code of Maryland, and regulations adopted under that Act.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Term."> <paragraph num="A."> <text>A temporary license expires on the date when licenses are issued to those who pass the first examination for a general license to practice dental hygiene given over 30 days after the effective date of the temporary license.</text> </paragraph> <paragraph num="B."> <text>Notification that the temporary licensee has failed the first examination for a general license to practice dental hygiene given over 30 days after the effective date of the temporary license shall serve as notice of the expiration of that temporary license.</text> </paragraph> <paragraph num="C."> <text>A temporary license to practice dental hygiene is not renewable.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-312, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 19, 1990 (17:3 Md. R. 301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective July 27, 1998 (25:15 Md. R. 1191)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective July 27, 1998 (25:15 Md. R. 1191)</annotation> </annotations> </chapter> <chapter num="18" heading="Parenteral Sedation" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: September 3, 1990 (17:17 Md. R. 2081)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective August 24, 1998 (25:17 Md. R. 1361)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C adopted effective August 24, 1998 (25:17 Md. R. 1361)</annotation> <annotation type="History" subtype="Administrative History">Regulations 01—.15 repealed effective January 4, 2010 (36:18 Md. R. 1380)</annotation> </annotations> </chapter> <chapter num="19" heading="Dental Radiation Technologist"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Dental radiation technologist” means an individual other than a licensed dentist or a licensed dental hygienist who practices dental radiation technology.</text> </paragraph> <paragraph num="(3)"> <text>“Direct supervision” means that the supervising dentist is in the dental office and personally:</text> <paragraph num="(a)"> <text>Diagnoses the condition to be treated:</text> </paragraph> <paragraph num="(b)"> <text>Authorizes the placement or exposure of dental radiographs; and</text> </paragraph> <paragraph num="(c)"> <text>Before dismissal of the patient, evaluates the performance of the dental radiation technologists.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Licensed dental hygienist” means an individual licensed by the Board to practice dental hygiene.</text> </paragraph> <paragraph num="(5)"> <text>“Licensed dentist” means an individual licensed by the Board to practice dentistry.</text> </paragraph> <paragraph num="(6)"> <text>“Practice of dental radiation technology” means the placement or exposure of dental radiographs by an individual other than a licensed dentist, a licensed dental hygienist, an individual permitted to practice dentistry without a license under Health Occupations Article, §4-301(b)(1), (2), or (3), Annotated Code of Maryland, or an individual enrolled in an educational program recognized by the Board for dental hygiene or dental assisting, who places or exposes dental radiographs pursuant to the educational program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Certification Required."> <text>An individual shall be currently certified by the Board as a dental radiation technologist before the individual may practice dental radiation technology on a human being in this State.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications."> <paragraph num="A."> <text>Except as otherwise provided in these regulations, to qualify to be certified as a dental radiation technologist, an applicant shall be an individual who:</text> <paragraph num="(1)"> <text>Is 18 years old or older;</text> </paragraph> <paragraph num="(2)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(3)"> <text>Holds a high school degree or the equivalent;</text> </paragraph> <paragraph num="(4)"> <text>Satisfactorily completes the Board-approved educational requirements established by the Maryland State Dental Association or the Maryland Dental Society;</text> </paragraph> <paragraph num="(5)"> <text>Successfully completes a Board-approved course of at least 24 hours related to Maryland dental radiology; and</text> </paragraph> <paragraph num="(6)"> <text>Passes an examination administered or approved by the Board for qualifying to place and expose radiographs; and</text> </paragraph> <paragraph num="(7)"> <text>Meets any requirements established by the American Dental Association or any applicable federal standards for training and certification as a dental radiation technologist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual holding an active license or certification to practice dental radiation technology in another state may be granted certification in Maryland if the individual:</text> <paragraph num="(1)"> <text>Has engaged in practicing dental radiation technology for at least 150 hours in the 3 years preceding application for certification in Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Meets any requirements established by the American Dental Association or any applicable federal standards for training and certification as a dental radiation technologist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Certification."> <text>Except as otherwise provided in these regulations, the Board shall certify as a dental radiation technologist an individual who:</text> <paragraph num="A."> <text>Meets the qualifications for certification;</text> </paragraph> <paragraph num="B."> <text>Applies for certification on a form provided by the Board; and</text> </paragraph> <paragraph num="C."> <text>Pays a fee to the Board as set forth in COMAR 10.44.20.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Term and Renewal of Certification."> <paragraph num="A."> <text>A certification as a dental radiation technologist expires on the second anniversary of the issuance of the certification unless it is renewed for an additional 2-year term as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>At least 2 months before a certification as a dental radiation technologist expires, the Board shall send, by first-class mail to the last known address of the individual so certified, a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current certification expires;</text> </paragraph> <paragraph num="(2)"> <text>Date by which the renewal application has to be received by the Board for the renewal to be issued and mailed before the certification expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before a certification as a dental radiation technologist expires, the individual so certified periodically may renew the certification for an additional 2 years if the individual:</text> <paragraph num="(1)"> <text>Applies for renewal of the certification on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a fee as set forth in COMAR 10.44.20; and</text> </paragraph> <paragraph num="(3)"> <text>Meets one of the following requirements:</text> <paragraph num="(a)"> <text>Has actively practiced dental radiation technology for at least 600 hours within the 6 years before the expiration of the certification; or</text> </paragraph> <paragraph num="(b)"> <text>If the applicant has not actively practiced dental radiation technology in accordance with §C(3)(a) of this regulation, provides to the Board evidence satisfactory to the Board that the individual has completed 8 classroom hours of dental continuing education, 4 hours of which shall be on the subject of radiation safety within the 1-year period preceding renewal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of §C of this regulation, a dental radiation technologist seeking renewal of a certificate shall complete a 2-hour Board-approved course on infection control.</text> </paragraph> <paragraph num="E."> <text>In addition to the requirements of §C of this regulation, a dental radiation technologist seeking renewal of a certificate in 2025 and thereafter shall complete a 3-hour Board-approved course on infection control.</text> </paragraph> <paragraph num="F."> <text>The infection control course identified in §E of this regulation shall be a single 3-hour course, which teaches the practices contained in the document Centers for Disease Control and Prevention, Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care, Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; October 2016, or its successor document.</text> </paragraph> <paragraph num="G."> <text>After the expiration date of a certificate to practice dental radiation technology in the State, the certificate holder may renew the certificate within 30 days of its expiration if the certificate holder:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be issued a certificate;</text> </paragraph> <paragraph num="(2)"> <text>Complies with the requirements of §§C(3) and D of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board a completed renewal application on the form provided by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Board the renewal fee and the late renewal fee as specified in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Certification After April 1.</text> <paragraph num="(1)"> <text>A certificate holder who has failed to renew a certificate to practice dental radiation technology in this State by April 1 of the year in which the certificate is due for renewal is prohibited from practicing dental radiation technology in this State after the expiration date of the certificate.</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that a dental radiation technologist has practiced dental radiation technology in this State after the certificate has expired, the Board may order the dental radiation technologist to immediately cease and desist the practice of dental radiation technology in this State until the dental radiation technologist's certificate has been reinstated by the Board.</text> </paragraph> <paragraph num="(3)"> <text>The Board may take action against a dental radiation technologist for unprofessional conduct if the Board determines that the dental radiation technologist has practiced dental radiation technology in this State after the dental radiation technologist's certificate has expired. The Board may impose an administrative penalty through a nonpublic consent agreement in which the dental radiation technologist agrees to:</text> <paragraph num="(a)"> <text>Make an anonymous donation of $100 to a charitable institution; and</text> </paragraph> <paragraph num="(b)"> <text>Perform:</text> <paragraph num="(i)"> <text>10 hours of Board-approved pro bono community service; or</text> </paragraph> <paragraph num="(ii)"> <text>10 hours of Board-approved pro bono dental services which the applicant may lawfully perform.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Notwithstanding the provisions of §E of this regulation, the Board may charge the dental radiation technologist with unprofessional conduct as provided in Regulation .11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reinstatement."> <paragraph num="A."> <text>An individual holding an expired certification to practice dental radiation technology may apply for reinstatement if the individual:</text> <paragraph num="(1)"> <text>Completes a dental radiation technology reinstatement application;</text> </paragraph> <paragraph num="(2)"> <text>Provides proof of 10 hours of dental continuing education from Board-approved courses of which:</text> <paragraph num="(a)"> <text>4 hours shall be in radiology; and</text> </paragraph> <paragraph num="(b)"> <text>2 hours shall be in infection control; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pays to the Board a certification reinstatement fee as set forth in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Commencing on January 1, 2025, and thereafter, a dental radiation technologist who applies for reinstatement of an expired certification shall complete the 3-hour Board-approved infection control course identified in Regulation .05E and F of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prohibitions."> <paragraph num="A."> <text>An individual may not practice dental radiation technology on a human being in this State unless the individual is certified by the Board as a dental radiation technologist.</text> </paragraph> <paragraph num="B."> <text>An individual shall be certified by the Board as a dental radiation technologist before a licensed dentist may employ the individual to practice dental radiation technology.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Title."> <text>A certified dental radiation technologist may be referred to as a dental assistant certified to practice dental radiation technology.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Supervision."> <text>A certified dental radiation technologist shall perform the duties of a dental radiation technologist under the direct supervision of a licensed dentist.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Display of Certificate."> <text>Each holder of a certificate to practice dental radiation technology shall display the certificate conspicuously in the office where the holder is engaged in practice.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Penalties for Violations of These Regulations."> <paragraph num="A."> <text>Subject to the hearing provisions of this chapter, the Board may deny a certificate to practice dental radiation technology, reprimand any certified dental radiation technologist, place any certified dental radiation technologist on probation, or suspend or revoke the certificate of any certified dental radiation technologist, if the holder of the certificate:</text> <paragraph num="(1)"> <text>Practices dental radiation technology in an incompetent manner;</text> </paragraph> <paragraph num="(2)"> <text>Fails to conform to generally accepted standards in the practice of radiation technology;</text> </paragraph> <paragraph num="(3)"> <text>Fraudulently or deceptively obtains or attempts to obtain a certificate for the applicant or for another;</text> </paragraph> <paragraph num="(4)"> <text>Fraudulently or deceptively uses a certificate;</text> </paragraph> <paragraph num="(5)"> <text>Is disciplined by a disciplinary authority of any other state or jurisdiction or is convicted or disciplined by a court in any other state or jurisdiction for an act that would be grounds for disciplinary action under this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Violates any rule or regulation adopted by the Board;</text> </paragraph> <paragraph num="(7)"> <text>Is convicted of or pleads guilty or nolo contendere to a felony or a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(8)"> <text>Provides professional services while under the influence of alcohol or any controlled dangerous substance or drug in excess of therapeutic amounts;</text> </paragraph> <paragraph num="(9)"> <text>Willfully makes or files a false report or record or fails to file a report or record in the practice of dental radiation technology or willfully induces another to file a false report;</text> </paragraph> <paragraph num="(10)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the certified individual is qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="(11)"> <text>Except in an emergency life-threatening situation where it is not feasible or practicable, fails to comply with the Center for Disease Control's guidelines on universal precautions;</text> </paragraph> <paragraph num="(12)"> <text>Fails to comply with a Board order;</text> </paragraph> <paragraph num="(13)"> <text>Is mentally or physically incompetent to practice dental radiation technology;</text> </paragraph> <paragraph num="(14)"> <text>Engages in sexual misconduct as set forth in COMAR 10.44.23; or</text> </paragraph> <paragraph num="(15)"> <text>Behaves dishonorably or unprofessionally.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual who practices dental radiation technology without being certified under these regulations is guilty of practicing dentistry without a license, a misdemeanor which, upon conviction, may result in:</text> <paragraph num="(1)"> <text>For a first offense, a fine not exceeding $2,000 or imprisonment in jail not exceeding 6 months; or</text> </paragraph> <paragraph num="(2)"> <text>For a subsequent offense, a fine not exceeding $6,000 or imprisonment in the State penitentiary not exceeding 1 year.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensed dentist who employs an individual to practice dental radiation technology who is not certified under these regulations is guilty of unprofessional conduct and may be subject to disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A licensed dentist who supervises an individual practicing dental radiation technology who is not certified under these regulations is guilty of permitting an unauthorized individual to practice dentistry under the supervision of that licensed dentist, and may be subject to disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 4-505, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 18, 1991 (18:3 Md. R. 306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 8, 1999 (26:5 Md. R. 392); April 12, 2004 (31:7 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 20, 1994 (21:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective November 20, 1994 (21:23 Md. R. 1934); April 1, 2002 (29:6 Md. R. 568); April 12, 2004 (31:7 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective February 23, 1998 (25:4 Md. R. 244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective March 8, 1999 (26:5 Md. R. 392); April 1, 2002 (29:6 Md. R. 568); April 12, 2004 (31:7 Md. R. 585); September 13, 2004 (31:18 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 19, 2001 (28:3 Md. R. 206)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 21, 2015 (42:25 Md. R. 1544)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 6, 2016 (43:11 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 1, 2025 (51:22 Md. R. 963)</annotation> </annotations> </chapter> <chapter num="20" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>A person shall pay a fee as set forth in Regulation .02 of this chapter by check or money order.</text> </paragraph> <paragraph num="B."> <text>The Board shall provide a copy of this chapter:</text> <paragraph num="(1)"> <text>Along with any application form or renewal form; and</text> </paragraph> <paragraph num="(2)"> <text>To any other person on request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall refund the initial licensure or renewal fee, less a $50 processing fee, to a dentist or a dental hygienist who does not qualify for initial licensure or renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fee Schedule."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Initial application fee:</text> <paragraph num="(1)"> <text>Dentist . . . $450;</text> </paragraph> <paragraph num="(2)"> <text>Dental hygienist . . . $275;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Limited license fee:</text> <paragraph num="(1)"> <text>Dentist . . . $225;</text> </paragraph> <paragraph num="(2)"> <text>Credentials processing (foreign dental school graduate surcharge) . . . $75;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Teacher's license fee:</text> <paragraph num="(1)"> <text>Dentist . . . $225;</text> </paragraph> <paragraph num="(2)"> <text>Dental hygienist . . . $225;</text> </paragraph> <paragraph num="(3)"> <text>Credentials processing (foreign school graduate surcharge) . . . $75;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Temporary license application fee — dental hygienist . . . $75;</text> </paragraph> <paragraph num="E."> <text>Application fee for dentists licensed in another state . . . $450;</text> </paragraph> <paragraph num="F."> <text>Application fee for dental hygienists licensed in another state . . . $275;</text> </paragraph> <paragraph num="G."> <text>License renewal fee:</text> <paragraph num="(1)"> <text>Dentist . . . $560;</text> </paragraph> <paragraph num="(2)"> <text>Dental hygienist . . . $182;</text> </paragraph> <paragraph num="(3)"> <text>Teacher's license . . . $225;</text> </paragraph> <paragraph num="(4)"> <text>Dentist late renewal fee (July 1 through July 31 of the year in which the renewal is due) . . . $300;</text> </paragraph> <paragraph num="(5)"> <text>Dental hygienist late renewal fee (July 1 through July 31 of the year in which the renewal is due) . . . $150;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Dental radiation technologist certification fee:</text> <paragraph num="(1)"> <text>Certification renewal . . . $68;</text> </paragraph> <paragraph num="(2)"> <text>For the renewal period ending March 1, 2017, a one-time 1-year certificate for dental radiation technologists whose certificates end in an even number . . . $34;</text> </paragraph> <paragraph num="(3)"> <text>Certification reinstatement . . . $118;</text> </paragraph> <paragraph num="(4)"> <text>For the period March 2, 2017 through April 1, 2017, for the 2017 renewal period, a late renewal fee for dental radiation technologists whose certificates end in an even number . . . $25;</text> </paragraph> <paragraph num="(5)"> <text>On and after April 2, 2017, for the 2017 renewal period, a certification reinstatement fee for dental radiation technologists whose certificates end in an even number . . . $59;</text> </paragraph> <paragraph num="(6)"> <text>For the period March 2, 2018 through April 1, 2018, for the 2018 renewal period, a late renewal fee for dental radiation technologists whose certificates end in an even number . . . $25;</text> </paragraph> <paragraph num="(7)"> <text>On and after April 2, 2018, for the 2018 renewal period, a certification reinstatement fee for dental radiation technologists whose certificates end in an even number . . . $59;</text> </paragraph> <paragraph num="(8)"> <text>Late renewal fee (March 2 through April 1 of the year in which the renewal is due) . . . $50;</text> </paragraph> <paragraph num="(9)"> <text>Initial application fee for applicants holding an active license or certification to practice dental radiation technology in another state . . . $20;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Reinstatement of lapsed license fee:</text> <paragraph num="(1)"> <text>Dentist . . . $860;</text> </paragraph> <paragraph num="(2)"> <text>Dentist—teacher's license . . . $225;</text> </paragraph> <paragraph num="(3)"> <text>Dental hygienist . . . $332;</text> </paragraph> <paragraph num="(4)"> <text>Dental hygienist—teacher's license . . . $225;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Lost, destroyed, or duplicate license fee . . . $15;</text> </paragraph> <paragraph num="K."> <text>Verification of licensure fee . . . $20;</text> </paragraph> <paragraph num="L."> <text>Specialty identification fee (one-time only) . . . $150;</text> </paragraph> <paragraph num="M."> <text>Advanced clinical training continuing education program application fee for a dentist who does not hold a Maryland license . . . $25;</text> </paragraph> <paragraph num="N."> <text>Dental assistant examination fee . . . $20;</text> </paragraph> <paragraph num="O."> <text>Class I and Class II permit fees:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $300;</text> </paragraph> <paragraph num="(3)"> <text>Additional location for a like permit — further evaluation not necessary . . . $500;</text> </paragraph> <paragraph num="(4)"> <text>Additional location for a like permit — further evaluation necessary . . . $700;</text> </paragraph> <paragraph num="(5)"> <text>Renewal of additional location for a like permit . . . $300;</text> </paragraph> </paragraph> <paragraph num="P."> <text>Class III permit fees:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $600;</text> </paragraph> <paragraph num="(3)"> <text>Additional location for a like permit — further evaluation not necessary . . . $600;</text> </paragraph> <paragraph num="(4)"> <text>Additional location for a like permit — further evaluation necessary . . . $700;</text> </paragraph> <paragraph num="(5)"> <text>Renewal of additional location for a like permit . . . $600;</text> </paragraph> </paragraph> <paragraph num="P-1."> <text>Conversion of parenteral sedation administration permit to a Class II permit . . . $300;</text> </paragraph> <paragraph num="P-2."> <text>Conversion of a general anesthesia administration permit to a Class III permit . . . $600;</text> </paragraph> <paragraph num="Q."> <text>Class III dental school facility permit fee:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $600;</text> </paragraph> <paragraph num="(3)"> <text>Additional location permit . . . $600;</text> </paragraph> <paragraph num="(4)"> <text>Renewal of additional location permit . . . $600;</text> </paragraph> </paragraph> <paragraph num="R."> <text>Certificate fee for a treating dentist to allow another dentist or physician to administer anesthesia and sedation at the site of the treating dentist:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $300;</text> </paragraph> <paragraph num="(3)"> <text>Additional location certificate . . . $300;</text> </paragraph> <paragraph num="(4)"> <text>Renewal of additional location certificate . . . $300;</text> </paragraph> </paragraph> <paragraph num="S."> <text>Certificate fee for a treating dentist to treat a patient at a practice location other than their own, at which anesthesia and sedation is administered to the patient:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $300;</text> </paragraph> <paragraph num="(3)"> <text>Additional location certificate . . . $300;</text> </paragraph> <paragraph num="(4)"> <text>Renewal of additional location certificate . . . $300;</text> </paragraph> </paragraph> <paragraph num="T."> <text>Single fee for dental hygienist recognition as qualified to administer local anesthesia, or qualified to administer nitrous oxide, or qualified to prescribe and administer medication, or any combination thereof . . . $50;</text> </paragraph> <paragraph num="U."> <text>Certificate fee for a treating dentist to allow a certified registered nurse anesthetist to administer anesthesia and sedation at a specific practice location:</text> <paragraph num="(1)"> <text>Initial application . . . $1000;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $300;</text> </paragraph> <paragraph num="(3)"> <text>Additional location certificate . . . $300;</text> </paragraph> <paragraph num="(4)"> <text>Renewal of additional location certificate . . . $300;</text> </paragraph> </paragraph> <paragraph num="V."> <text>Inactive status application fee (per renewal):</text> <paragraph num="(1)"> <text>Dentist . . . $150;</text> </paragraph> <paragraph num="(2)"> <text>Dental hygienist . . . $75;</text> </paragraph> </paragraph> <paragraph num="W."> <text>Board fee for full permit to dispense prescription drugs . . . $75;</text> </paragraph> <paragraph num="X."> <text>Required Division of Drug Control inspection fee for full permit to dispense prescription drugs . . . $1,000;</text> </paragraph> <paragraph num="Y."> <text>Limited permit for dispensing prescription drugs:</text> <paragraph num="(1)"> <text>Initial application . . . $75;</text> </paragraph> <paragraph num="(2)"> <text>Renewal . . . $75;</text> </paragraph> </paragraph> <paragraph num="Z."> <text>Application reprocessing fee . . . $50;</text> </paragraph> <paragraph num="AA."> <text>Corporate name application fee . . . $150;</text> </paragraph> <paragraph num="BB."> <text>Returned check fee . . . $25;</text> </paragraph> <paragraph num="CC."> <text>Late fee for failure to notify the Board within 60 days of change of address . . . $10;</text> </paragraph> <paragraph num="DD."> <text>Dentists — diskettes, labels, rosters, or tapes . . . $190;</text> </paragraph> <paragraph num="EE."> <text>Dental hygienists — diskettes, labels, rosters, or tapes . . . $130;</text> </paragraph> <paragraph num="FF."> <text>Dental assistants — diskettes, labels, rosters, or tapes . . . $145;</text> </paragraph> <paragraph num="GG."> <text>Jurisprudence Examination . . . $50; and</text> </paragraph> <paragraph num="HH."> <text>Copy of Maryland Laws and Regulations on computer disc or booklet . . . $25.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-205, 4-207, 4-304, 4-505, and 12-102.1, Annotated Code of Maryland; Ch.469, Acts of 2006</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective August 1, 1992 (19:16 Md. R. 1469); adopted permanently effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 adopted as an emergency provision effective August 1, 1992 (19:16 Md. R. 1469); adopted permanently effective February 15, 1993 (20:3 Md. R. 259)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 13, 1995 (22:3 Md. R. 154); November 4, 1996 (23:22 Md. R. 1497); April 19, 1999 (26:8 Md. R. 616); August 7, 2000 (27:15 Md. R. 1400)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective November 12, 2002 (29:24 Md. R. 1915); amended permanently effective February 17, 2003 (30:3 Md. R. 181)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 29, 2004 (31:6 Md. R. 509); July 17, 2006 (33:14 Md. R. 1164); September 10, 2007 (34:18 Md. R. 1580); October 20, 2008 (35:21 Md. R. 1825); May 31, 2010 (37:11 Md. R. 765); March 7, 2011 (38:5 Md. R. 318); April 29, 2013 (40:8 Md. R. 724); July 20, 2015 (42:14 Md. R. 880); September 5, 2022 (49:18 Md. R. 819)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended effective January 2, 2006 (32:26 Md. R. 1997)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H amended effective August 16, 2004 (31:16 Md. R. 1256); June 6, 2016 (43:11 Md. R. 634); January 2, 2017 (43:26 Md. R. 1447)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I amended effective October 23, 2006 (33:21 Md. R. 1677)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02V amended effective November 24, 2016 (43:23 Md. R. 1279)</annotation> </annotations> </chapter> <chapter num="21" heading="Practice of Dental Hygiene Under General Supervision in a Facility or Long-Term Care Facility"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the practice of dental hygiene in a facility and in a long-term care facility. The practice of dental hygiene in long-term care facilities is specifically governed in Regulation .10 of this chapter. The practice of dental hygiene in a private dental office is governed by COMAR 10.44.27.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assisted living program” has the meaning stated in Health Occupations Article, §19-1801, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Contractual employee” means a dental hygienist who has an annual contract to practice dental hygiene an average of at least 8 hours per week in a facility identified in Regulation .09A of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Facility” as used in Regulation .09 of this chapter includes a program operated within a facility that is specified under Regulation .09 of this chapter, but excludes “long-term care facilities” which are regulated in Regulation .10 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Federally qualified health center” has the meaning stated in 42 U.S.C. §254b(a).</text> </paragraph> <paragraph num="(5)"> <text>“Federally qualified health center look-alike” has the meaning stated in 42 U.S.C. §1396d(l)(2)(B).</text> </paragraph> <paragraph num="(6)"> <text>“General supervision” means the supervision of a dental hygienist by a dentist where the dentist may or may not be present when the dental hygienist performs the dental hygiene procedures.</text> </paragraph> <paragraph num="(7)"> <text>“Long-term care facility” means:</text> <paragraph num="(a)"> <text>A nursing home; or</text> </paragraph> <paragraph num="(b)"> <text>An assisted living program.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Nursing home” has the meaning stated in Health Occupations Article, §19-1401, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“On-site supervision” means the supervision of a dental hygienist by a dentist who is physically present on the premises and may or may not be present in the operatory when the dental hygiene services are provided.</text> </paragraph> <paragraph num="(10)"> <text>“Waiver of on-site supervision” means that a facility has been approved by the Board to enable a licensed dental hygienist to provide dental hygiene services under general supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Supervision Requirements in a Facility."> <text>Unless a facility is operating pursuant to this chapter, a general license to practice dental hygiene in a facility authorizes the licensee to practice dental hygiene only under the on-site supervision of a licensed dentist.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualification for Practice Under General Supervision by Report to the Board."> <paragraph num="A."> <text>With the exception of those facilities identified in Regulations .09A and .10 of this chapter, a facility is qualified to permit a dental hygienist to practice under general supervision if the facility has filed a report with the Board and the facility is owned or operated by:</text> <paragraph num="(1)"> <text>The federal government;</text> </paragraph> <paragraph num="(2)"> <text>The State government;</text> </paragraph> <paragraph num="(3)"> <text>A county or local government; or</text> </paragraph> <paragraph num="(4)"> <text>A public health department of the federal, State, or local government.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A facility shall include in the report to the Board:</text> <paragraph num="(1)"> <text>The name of the federal, State, or local government agency which owns or operates the facility;</text> </paragraph> <paragraph num="(2)"> <text>The location of the facility and all other sites where dental hygiene services will be provided;</text> </paragraph> <paragraph num="(3)"> <text>The name of the supervising dentist affiliated with the facility who will be responsible for carrying out the requirements necessary for the facility to operate under general supervision; and</text> </paragraph> <paragraph num="(4)"> <text>The names of the dental hygienists who will provide dental hygiene services under general supervision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A facility which is qualified for practice under general supervision by report to the Board may do so on receipt of the report by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Waiver of On-Site Supervision by Application to the Board."> <paragraph num="A."> <text>With the exception of those facilities identified in Regulations .09A and .10 of this chapter, the Board may grant on a case-by-case basis a waiver of on-site supervision qualifying a facility to permit the practice of dental hygiene under general supervision, after the facility has made application to the Board, if the facility is a health facility that is licensed by the Maryland Department of Health and:</text> <paragraph num="(1)"> <text>Provides medical care to the poor, elderly, or handicapped;</text> </paragraph> <paragraph num="(2)"> <text>Is owned or operated by a charitable institution;</text> </paragraph> <paragraph num="(3)"> <text>Is a federal-qualified or State-qualified community health care program; or</text> </paragraph> <paragraph num="(4)"> <text>Is a setting otherwise authorized by the Board to provide dental hygiene services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall include in the application for a waiver of on-site supervision the following:</text> <paragraph num="(1)"> <text>The name of the facility;</text> </paragraph> <paragraph num="(2)"> <text>The location of the facility;</text> </paragraph> <paragraph num="(3)"> <text>The name and signature of each supervising dentist responsible for carrying out the requirements necessary for the facility to operate under a waiver of on-site supervision affirming that the dentist understands and accepts those responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>The name and signature of each dental hygienist who will provide dental hygiene services at the facility under a waiver of on-site supervision affirming that the dental hygienist understands and accepts the terms of the waiver of on-site supervision;</text> </paragraph> <paragraph num="(5)"> <text>The supervisory responsibilities of the supervising dentist or dentists;</text> </paragraph> <paragraph num="(6)"> <text>A description of the program and how the program will operate and be administered;</text> </paragraph> <paragraph num="(7)"> <text>A description of a medical emergency plan of action; and</text> </paragraph> <paragraph num="(8)"> <text>A description of the facility that demonstrates that it has adequate equipment for the delivery of dental hygiene services, unless the dental hygiene services that are provided are limited to fluoride rinse programs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall grant or deny an application for waiver of on-site supervision:</text> <paragraph num="(1)"> <text>Within 60 calendar days after receipt of the application by the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Within 90 calendar days after receipt of the application by the Board, if the Board notifies the applicant that extraordinary circumstances exist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board fails to grant or deny an application within the appropriate time, the Board shall consider the application granted.</text> </paragraph> <paragraph num="E."> <text>The Board may, on written request or its own motion, conduct a public informational hearing on the granting or denial of a waiver of on-site supervision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Term and Renewal of Qualification of a Facility To Operate Under General Supervision."> <paragraph num="A."> <text>A report or waiver issued by the Board under this chapter is effective for a 5-year term.</text> </paragraph> <paragraph num="B."> <text>At least 90 days before the expiration of the 5-year term, the Board shall notify the facility of the expiration of the report or waiver and send to the facility an application for renewal of the waiver.</text> </paragraph> <paragraph num="C."> <text>A facility seeking to renew a report to qualify for practice under general supervision shall file a new report with the Board not later than 60 days before the expiration of the existing 5-year term.</text> </paragraph> <paragraph num="D."> <text>A facility seeking to renew a waiver of on-site supervision shall file the application with the Board not later than 60 days before the expiration of the existing waiver.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Requirements for Dentists and Dental Hygienists to Operate Under General Supervision in a Facility."> <paragraph num="A."> <text>Each supervising dentist responsible for carrying out the requirements necessary for the facility to operate under general supervision shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dentistry in this State;</text> </paragraph> <paragraph num="(2)"> <text>Hold a current certificate of Health Care Provider Level C Proficiency, or its equivalent, in Cardiopulmonary Resuscitation; and</text> </paragraph> <paragraph num="(3)"> <text>Have at least 2 years experience in providing direct patient care in the active clinical practice of dentistry.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each dental hygienist providing dental hygiene services under general supervision shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dental hygiene in this State;</text> </paragraph> <paragraph num="(2)"> <text>Hold a current certificate of Health Care Provider Level C Proficiency, or its equivalent, in Cardiopulmonary Resuscitation; and</text> </paragraph> <paragraph num="(3)"> <text>Have at least 2 years experience in direct patient care in the active clinical practice of dental hygiene.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Within 30 days after there has been a change in either the supervising dentist or the dental hygienist, a facility shall notify the Board in writing of the following:</text> <paragraph num="(1)"> <text>The name of the new supervising dentist or the new dental hygienist;</text> </paragraph> <paragraph num="(2)"> <text>The date of the change in personnel; and</text> </paragraph> <paragraph num="(3)"> <text>A statement affirming that all personnel meet the criteria established in this regulation for practice under general supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Guidelines for Operating Under General Supervision in a Facility."> <paragraph num="A."> <text>A facility shall provide adequate facilities and equipment for the delivery of dental hygiene services;</text> </paragraph> <paragraph num="B."> <text>Each time a patient receives dental hygiene services under general supervision, the dental hygienist shall determine, before initiation of treatment, that there has been no change in the patient's medical history;</text> </paragraph> <paragraph num="C."> <text>If there is a change in the medical history of the patient, the dental hygienist shall consult with the supervising dentist, the patient's own dentist, the facility's dental consultant, or the patient's treating physician before providing dental hygiene services; and</text> </paragraph> <paragraph num="D."> <text>All recall patients seen by a dental hygienist working under general supervision shall be scheduled for an oral examination with a dentist every 6 months or as otherwise recommended by the supervising dentist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Exceptions."> <paragraph num="A."> <text>This regulation applies to the following facilities:</text> <paragraph num="(1)"> <text>A dental facility owned and operated by:</text> <paragraph num="(a)"> <text>The federal government;</text> </paragraph> <paragraph num="(b)"> <text>The State government; or</text> </paragraph> <paragraph num="(c)"> <text>A county or local government;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A public health department of:</text> <paragraph num="(a)"> <text>The State; or</text> </paragraph> <paragraph num="(b)"> <text>A county or local government;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A public school of:</text> <paragraph num="(a)"> <text>The State; or</text> </paragraph> <paragraph num="(b)"> <text>A county or local government;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A facility in which a program licensed by the Maryland Department of Health is operating;</text> </paragraph> <paragraph num="(5)"> <text>A facility owned and operated by the Department of Juvenile Services;</text> </paragraph> <paragraph num="(6)"> <text>A facility owned and operated by the State, county, or local government that provides medical care to the poor, elderly, or handicapped;</text> </paragraph> <paragraph num="(7)"> <text>A facility in which a federally qualified health center or a federally qualified health center look-alike is located; or</text> </paragraph> <paragraph num="(8)"> <text>A facility in which a State-licensed Head Start Program or Early Head Start Program operates.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A general license to practice dental hygiene authorizes the licensee to practice dental hygiene under general supervision in a facility identified in §A of this regulation and apply:</text> <paragraph num="(1)"> <text>Sealants;</text> </paragraph> <paragraph num="(2)"> <text>Fluoride agents, such as professional topical fluoride agents;</text> </paragraph> <paragraph num="(3)"> <text>Mouth wash; or</text> </paragraph> <paragraph num="(4)"> <text>Varnish.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not require a facility identified in §A of this regulation to obtain a waiver in order to practice in accordance with §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>Before a facility may allow a dental hygienist to practice dental hygiene in a facility identified in §A of this regulation, the facility shall report to the Board:</text> <paragraph num="(1)"> <text>That the facility is operating under general supervision;</text> </paragraph> <paragraph num="(2)"> <text>The identity of each hygienist employed by the facility; and</text> </paragraph> <paragraph num="(3)"> <text>The identity of each supervising dentist.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A facility that authorizes a dental hygienist to practice dental hygiene in a facility identified in §A of this regulation shall insure that the supervising dentist for the facility:</text> <paragraph num="(1)"> <text>Holds an active general license to practice dentistry in the State;</text> </paragraph> <paragraph num="(2)"> <text>Holds a current certificate evidencing Health Care Provider Level C Proficiency, or its equivalent, in Cardiopulmonary Resuscitation; and</text> </paragraph> <paragraph num="(3)"> <text>Has at least 2 years of active clinical practice in direct patient care.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A facility that authorizes a dental hygienist to practice dental hygiene in a facility identified in §A of this regulation shall insure that the dental hygienist:</text> <paragraph num="(1)"> <text>Holds an active general license to practice dental hygiene in the State;</text> </paragraph> <paragraph num="(2)"> <text>Holds a current certificate evidencing Health Care Provider Level C Proficiency, or its equivalent, in Cardiopulmonary Resuscitation;</text> </paragraph> <paragraph num="(3)"> <text>Has at least 2 years of active clinical practice in direct patient care; and</text> </paragraph> <paragraph num="(4)"> <text>Is a permanent or contractual employee of:</text> <paragraph num="(a)"> <text>The federal government;</text> </paragraph> <paragraph num="(b)"> <text>A state government;</text> </paragraph> <paragraph num="(c)"> <text>A county or local government; or</text> </paragraph> <paragraph num="(d)"> <text>A federally qualified health center.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A facility that authorizes a dental hygienist to practice dental hygiene in a facility identified in §A of this regulation shall insure that:</text> <paragraph num="(1)"> <text>The facility has a medical emergency plan;</text> </paragraph> <paragraph num="(2)"> <text>Adequate equipment, including portable equipment where appropriate and appropriate armamentarium, is available for the appropriate delivery of dental hygiene services; and</text> </paragraph> <paragraph num="(3)"> <text>Adequate safeguards are present to protect the patient's health and safety.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Long-Term Care Facilities."> <paragraph num="A."> <text>A dental hygienist may practice dental hygiene under the general supervision of a dentist in a long-term care facility in accordance with this regulation.</text> </paragraph> <paragraph num="B."> <text>Initial Appointment. A dental hygienist practicing under the general supervision of a licensed dentist in a long-term care facility and performing an authorized dental hygiene service for a patient’s initial appointment shall:</text> <paragraph num="(1)"> <text>Have a written agreement between the supervising dentist and the dental hygienist that clearly sets forth the terms and conditions under which the dental hygienist may practice, including a statement that the dental hygienist may provide dental hygiene services without the dentist on the premises; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the supervising dentist is available for consultation with the dental hygienist:</text> <paragraph num="(a)"> <text>In person;</text> </paragraph> <paragraph num="(b)"> <text>By telephone; or</text> </paragraph> <paragraph num="(c)"> <text>Electronically.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A dental hygienist working under general supervision in a long-term care facility shall:</text> <paragraph num="(1)"> <text>Consult with the supervising dentist or a treating physician before proceeding with initial treatment if there has been a change in a recall patient’s medical history;</text> </paragraph> <paragraph num="(2)"> <text>Assess the appropriate recall interval based on the individual needs of the patient or as otherwise recommended by the supervising dentist;</text> </paragraph> <paragraph num="(3)"> <text>Limit dental hygiene tasks and procedures to:</text> <paragraph num="(a)"> <text>Toothbrush prophylaxis;</text> </paragraph> <paragraph num="(b)"> <text>Application of fluoride;</text> </paragraph> <paragraph num="(c)"> <text>Dental hygiene instruction; and</text> </paragraph> <paragraph num="(d)"> <text>Other duties as may be delegated, verbally or in writing, by the supervising dentist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A dental hygienist shall:</text> <paragraph num="(1)"> <text>Assess the patient’s apparent need for further evaluation by a dentist in order to diagnose the presence of dental disease; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the findings of the initial assessment to the supervising dentist for a determination of future treatment.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A dental hygienist may perform subsequent authorized dental hygiene services without the supervising dentist on the premises only if:</text> <paragraph num="(1)"> <text>The supervising dentist examines the patient and authorizes in the patient’s record a prescription of specific treatment to be provided by the dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>An authorized treatment is provided by the dental hygienist as soon as possible, but no later than 7 months from the date the patient was examined by the supervising dentist.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Upon expiration of a prescribed treatment, the supervising dentist is responsible for determining future protocols for the treatment of the patient.</text> </paragraph> <paragraph num="G."> <text>Qualifications of a Dental Hygienist. Before a dental hygienist is authorized to practice dental hygiene under general supervision in a long-term care facility, the dental hygienist shall:</text> <paragraph num="(1)"> <text>Hold an active license to practice dental hygiene in the State;</text> </paragraph> <paragraph num="(2)"> <text>Hold a current certificate evidencing Health Care Provider Level C Proficiency, or its equivalent, in cardiopulmonary resuscitation;</text> </paragraph> <paragraph num="(3)"> <text>Have at least 2 years of active clinical practice in direct patient care; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the long-term care facility where the dental hygienist will practice under general supervision has:</text> <paragraph num="(a)"> <text>A written medical emergency plan in place;</text> </paragraph> <paragraph num="(b)"> <text>Adequate equipment, including portable equipment and appropriate armamentarium, available for the appropriate delivery of dental hygiene services; and</text> </paragraph> <paragraph num="(c)"> <text>Adequate safeguards to protect the patient’s health and safety.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Qualifications of a Dentist. Before a dental hygienist is authorized to practice dental hygiene under general supervision in a long-term care facility, the supervising dentist shall:</text> <paragraph num="(1)"> <text>Hold an active general license to practice dentistry in the State;</text> </paragraph> <paragraph num="(2)"> <text>Hold a current certificate evidencing Health Care Provider Level C Proficiency, or its equivalent, in cardiopulmonary resuscitation; and</text> </paragraph> <paragraph num="(3)"> <text>Have at least 2 years of active clinical practice in direct patient care.</text> </paragraph> </paragraph> <paragraph num="I."> <text>This regulation may not be construed to:</text> <paragraph num="(1)"> <text>Authorize a dental hygienist to practice dental hygiene independent of a supervising dentist;</text> </paragraph> <paragraph num="(2)"> <text>Prohibit a dentist from being available for personal consultation or on the premises where a dental hygienist is practicing; or</text> </paragraph> <paragraph num="(3)"> <text>Prohibit a dental hygienist, without the supervision of a dentist, from performing a preliminary dental examination with a subsequent referral to a dentist.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Long-term care facilities are not required to obtain a waiver from the Board pursuant to Health Occupations Article, §4-308(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="K."> <text>Before a long-term care facility may allow a dental hygienist to practice dental hygiene, the facility shall report to the Board:</text> <paragraph num="(1)"> <text>That the facility is operating under general supervision;</text> </paragraph> <paragraph num="(2)"> <text>The identity of each dental hygienist providing dental hygiene services in the facility; and</text> </paragraph> <paragraph num="(3)"> <text>The identity of each supervising dentist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Penalties."> <paragraph num="A."> <text>A violation of this chapter by a dentist or dental hygienist shall constitute unprofessional conduct.</text> </paragraph> <paragraph num="B."> <text>A violation of this chapter may result in revocation of the facility's right to operate under a waiver of on-site supervision.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-308, Annotated Code of Maryland;Ch. 221, Acts of 2003; Ch. 164 and 165, Acts of 2007; Ch. 733, Acts of 2010</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 adopted as an emergency provision effective April 11, 1994 (21:9 Md. R. 747); emergency status expired October 7, 1994</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .09 adopted effective October 10, 1994 (21:20 Md. R. 1733)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Waiver of Supervision Requirements for Dental Hygienists, repealed and new chapter, Practice of Dental Hygiene Under General Supervision, adopted effective October 4, 1999 (26:20 Md. R. 1546)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 11, 2003 (30:24 Md. R. 1743)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 14, 2005 (32:5 Md. R. 580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 22, 2007 (34:21 Md. R. 1916); January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 recodified to be Regulation .10 and new Regulation .09 adopted effective October 22, 2007 (34:21 Md. R. 1916)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 12, 2011 (38:25 Md. R. 1581)</annotation> </annotations> </chapter> <chapter num="22" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern the continuing education requirements for dentists and dental hygienists seeking renewal of their licenses.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Advanced Clinical Training Program.</text> <paragraph num="(a)"> <text>“Advanced clinical training program” means:</text> <paragraph num="(i)"> <text>A program of postgraduate training developed, offered, and sponsored by the University of Maryland Dental School as part of its curriculum for dental students or dental school graduates;</text> </paragraph> <paragraph num="(ii)"> <text>A program of postgraduate training offered by the University of Maryland Dental School as continuing education for licensed dentists; or</text> </paragraph> <paragraph num="(iii)"> <text>A program of postgraduate training offered by an approved continuing education sponsor or its equivalent as provided in Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Advanced clinical training program” includes clinical treatment provided to a patient by a student of dentistry while under the supervision of the training faculty.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Dental Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Continuing education” means any eligible course or program approved by the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Cultural competency” means courses or programs that teach a defined set of values, principles, demonstrated behaviors, attitudes, policies, and structures that will increase a licensee’s ability to work effectively in a cross-cultural manner.</text> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means that the supervising dentist personally:</text> <paragraph num="(a)"> <text>Diagnoses the condition to be treated;</text> </paragraph> <paragraph num="(b)"> <text>Authorizes the procedure; and</text> </paragraph> <paragraph num="(c)"> <text>Examines the patient before dismissal.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Licensee” means a licensed dentist or a licensed dental hygienist.</text> </paragraph> <paragraph num="(7)"> <text>“Significant change” means a change in a Board-approved continuing education program that in the sole discretion of the Board produces a measurable change in the course material or course objectives.</text> </paragraph> <paragraph num="(8)"> <text>“Student of dentistry” means:</text> <paragraph num="(a)"> <text>A student enrolled in a doctoral program in an accredited dental school with a curriculum leading to either a Doctor of Dental Surgery or Doctor of Dental Medicine degree;</text> </paragraph> <paragraph num="(b)"> <text>A graduate of a dental doctoral program enrolled in an advanced dental education program offered as a course of one semester or longer by the University of Maryland Dental School;</text> </paragraph> <paragraph num="(c)"> <text>A dentist licensed in Maryland who enrolls in an advanced clinical training program offered as a continuing education program for licensed dentists;</text> </paragraph> <paragraph num="(d)"> <text>A dentist licensed in another state, who does not hold a Maryland dental license and who:</text> <paragraph num="(i)"> <text>Enrolls in an advanced clinical training program offered as a continuing education program for licensed dentists; and</text> </paragraph> <paragraph num="(ii)"> <text>Receives written approval from the Board to participate in the advanced clinical training program;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>A dentist licensed in Maryland who enrolls in an advanced clinical training program offered as continuing education by an approved sponsor or its equivalent as provided in Regulation .08 of this chapter; or</text> </paragraph> <paragraph num="(f)"> <text>A dentist licensed in another state, who does not hold a Maryland dental license and who:</text> <paragraph num="(i)"> <text>Enrolls in an advanced clinical training program offered as continuing education by an approved sponsor or its equivalent as provided in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Receives written approval from the Board to participate in the advanced clinical training program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Webinar” means a live seminar or other presentation for continuing education credit that takes place on the Internet, allowing participants in different locations to see and hear the presenter and ask questions and receive responses in real time.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Records."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Maintain for 5 years accurate records of continuing education courses or programs in which the licensee has participated under these regulations; and</text> </paragraph> <paragraph num="(2)"> <text>Make continuing education records available to the Board or the Board's representative or representatives on request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On a renewal form provided by the Board, a licensee shall verify compliance with this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements."> <paragraph num="A."> <text>All continuing education credits shall be pre-approved by the Board.</text> </paragraph> <paragraph num="B."> <text>A licensee seeking renewal shall complete at least 30 full hours of Board-approved continuing education.</text> </paragraph> <paragraph num="C."> <text>Of the 30 hours of Board-approved continuing education, a minimum of 13 hours shall be completed with attendance at:</text> <paragraph num="(1)"> <text>In-person Board-approved courses or programs; or</text> </paragraph> <paragraph num="(2)"> <text>Webinars.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To be considered for Board approval, a webinar shall:</text> <paragraph num="(1)"> <text>Be designed to enhance the licensee’s clinical knowledge and ability to treat dental patients;</text> </paragraph> <paragraph num="(2)"> <text>Be presented in real time;</text> </paragraph> <paragraph num="(3)"> <text>Allow all participants an opportunity to interact with the instructor; and</text> </paragraph> <paragraph num="(4)"> <text>Allow the participants an ample opportunity to ask questions and receive responses in real time.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A pre-recorded webinar viewed by a licensee that otherwise meets the requirements of this chapter may be considered by the Board for continuing education credit toward the 17 hours that do not require in-person attendance.</text> </paragraph> <paragraph num="F."> <text>A maximum of 17 hours of Board-approved continuing education may be earned for self-study activities, including:</text> <paragraph num="(1)"> <text>Preparing and presenting table clinics;</text> </paragraph> <paragraph num="(2)"> <text>Preparing lectures; and</text> </paragraph> <paragraph num="(3)"> <text>Preparing articles for publication in dental journals.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Continuing education courses and programs shall meet the criteria established in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="H."> <text>A licensee shall maintain written documentation of successful completion of continuing education programs for 5 years.</text> </paragraph> <paragraph num="I."> <text>A licensee may not receive continuing education credit for a course or program that was:</text> <paragraph num="(1)"> <text>Not Board-approved; or</text> </paragraph> <paragraph num="(2)"> <text>Completed before the course or program gained Board approval.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Unless otherwise provided in this chapter, the Board may not accept a submission for continuing education credit of less</text> </paragraph> <paragraph num="K."> <text>A licensee shall maintain cardiopulmonary resuscitation certification from one of the following programs:</text> <paragraph num="(1)"> <text>The American Heart Association's Basic Life Support for Healthcare Providers;</text> </paragraph> <paragraph num="(2)"> <text>The American Red Cross's Cardiopulmonary Resuscitation for Professional Rescuers; or</text> </paragraph> <paragraph num="(3)"> <text>An equivalent program approved by the Board.</text> </paragraph> </paragraph> <paragraph num="L."> <text>A licensee seeking renewal shall complete a Board- approved course of 2 hours in infection control.</text> </paragraph> <paragraph num="M."> <text>A licensee seeking renewal in 2025 and thereafter shall complete a Board-approved course of 3 hours in infection control every renewal cycle.</text> </paragraph> <paragraph num="N."> <text>A licensee seeking renewal shall complete a Board-approved course of 2 hours in abuse and neglect.</text> </paragraph> <paragraph num="O."> <text>The 2-hour, Board-approved course in abuse and neglect required by §N of this regulation shall:</text> <paragraph num="(1)"> <text>Be completed by each licensee every other renewal cycle;</text> </paragraph> <paragraph num="(2)"> <text>Relate to Maryland law on the subject of abuse and neglect; and</text> </paragraph> <paragraph num="(3)"> <text>Count toward the 30 full hours of required continuing education.</text> </paragraph> </paragraph> <paragraph num="P."> <text>A dentist seeking renewal shall complete a 2-hour Board- approved course on proper prescribing and disposal of prescription drugs, which shall count toward the 30 full hours of required continuing education.</text> </paragraph> <paragraph num="Q."> <text>A dentist seeking renewal shall complete a 2-hour Board- approved course on proper prescribing and disposal of prescription drugs, which shall count toward the 30 full hours of required continuing education.</text> </paragraph> <paragraph num="R."> <text>Optional Pro Bono Program. A licensee seeking renewal may receive up to 8 continuing education hours for providing volunteer pro bono dental or dental hygiene services in accordance with Regulation .07 of this chapter.</text> </paragraph> <paragraph num="S."> <text>Cultural Competency, Military Culture, and Implicit Bias Training. A licensee may receive up to a combined total of 4 continuing education hours for Board-approved courses on:</text> <paragraph num="(1)"> <text>Cultural competency;</text> </paragraph> <paragraph num="(2)"> <text>Military culture; or</text> </paragraph> <paragraph num="(3)"> <text>Implicit bias training.</text> </paragraph> </paragraph> <paragraph num="T."> <text>A licensee may receive up to 2 continuing education hours for Board-approved courses on abuse and neglect.</text> </paragraph> <paragraph num="U."> <text>A study club course shall first receive Board approval before attendees may receive continuing education credit for attendance at the study club meeting.</text> </paragraph> <paragraph num="V."> <text>Dentists and dental hygienists may receive one continuing education credit for attending a regularly scheduled open session Board meeting in its entirety.</text> </paragraph> <paragraph num="W."> <text>The Board shall issue a certificate of completion to dentists and dental hygienists who attend a regularly scheduled open session Board meeting in its entirety.</text> </paragraph> <paragraph num="X."> <text>A dentist or a dental hygienist may earn up to two continuing education credits per renewal period for attendance at regularly scheduled open session Board meetings.</text> </paragraph> <paragraph num="Y."> <text>A licensee who has received a license within 6 months of graduation from an approved dental or dental hygiene school is not required to fulfill the continuing education requirements of the Board for the first renewal following initial licensure.</text> </paragraph> <paragraph num="Z."> <text>A licensee who is on inactive status shall provide evidence of compliance with the continuing education requirements of the Board for the 2-year period preceding application for reactivation of the licensee's license.</text> </paragraph> <paragraph num="AA."> <text>A licensee who fails to obtain the required continuing education due to disability or retirement shall comply with this regulation within 6 months of the licensee's return to practice.</text> </paragraph> <paragraph num="BB."> <text>The infection control course identified in §M of this regulation shall be a single 3-hour course which teaches the practices contained in the document Centers for Disease Control and Prevention, Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care, Atlanta, GA: Centers for Disease Control and Prevention, US Dept. of Health and Human Services; October 2016, or its successor document.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Time Frame for Completing Continuing Education."> <paragraph num="A."> <text>A. The period for completing continuing education requirements extends for a 2-year period from July 1 through June 30 of the second year following the effective date of the license.</text> </paragraph> <paragraph num="B."> <text>The 2-year period in which the continuing education shall be completed ends on June 30 of the year in which the license is due for renewal.</text> </paragraph> <paragraph num="C."> <text>For the renewal period beginning on June 1, 2025, only, the period for completing continuing education requirements extends for the period January 1, 2023, through June 30, 2025.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Course and Program Eligibility."> <paragraph num="A."> <text>Eligibility Guidelines.</text> <paragraph num="(1)"> <text>General. With the exceptions listed in §A(2) of this regulation, only those courses or programs that satisfy the following eligibility guidelines qualify for continuing education credit for license renewal:</text> <paragraph num="(a)"> <text>The course or program is designed to enhance the licensee's clinical knowledge and ability to treat dental patients; and</text> </paragraph> <paragraph num="(b)"> <text>The course or program is offered by a Board-approved sponsor.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Abuse and Neglect Courses, Cultural Competency Courses, Military Culture Courses, Implicit Bias Training Courses, and Pro Bono Programs. To qualify for continuing education credit for license renewal:</text> <paragraph num="(a)"> <text>The mandatory course in abuse and neglect identified in Regulation .04N and O of this chapter:</text> <paragraph num="(i)"> <text>Does not need to be designed to enhance the licensee’s clinical knowledge and ability to treat dental patients; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be offered by a Board-approved sponsor;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Cultural competency courses:</text> <paragraph num="(i)"> <text>Do not need to enhance the licensee’s clinical knowledge; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be offered by a Board-approved sponsor;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Military culture courses:</text> <paragraph num="(i)"> <text>Do not need to enhance the licensee’s clinical knowledge; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be offered by a Board-approved sponsor;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Implicit bias training courses:</text> <paragraph num="(i)"> <text>Do not need to be designed to enhance the licensee’s clinical knowledge and ability to treat dental patients; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be approved by the Maryland Office of Minority Health and Health Disparities.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Pro bono programs:</text> <paragraph num="(i)"> <text>Do not need to enhance the licensee’s clinical knowledge and ability to treat dental patients; and</text> </paragraph> <paragraph num="(ii)"> <text>Shall be offered by a Board-approved sponsor.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Excluded Courses and Programs. Courses and programs that are not approved for continuing education credit for license renewal include, but are not limited to, the subjects of:</text> <paragraph num="(1)"> <text>Money management;</text> </paragraph> <paragraph num="(2)"> <text>Personal finance;</text> </paragraph> <paragraph num="(3)"> <text>Personal business matters;</text> </paragraph> <paragraph num="(4)"> <text>With the exception of those courses or programs on cultural competency, military culture, and implicit bias training courses, cultural subjects;</text> </paragraph> <paragraph num="(5)"> <text>Personal health and recreation;</text> </paragraph> <paragraph num="(6)"> <text>Politics;</text> </paragraph> <paragraph num="(7)"> <text>Memory training; and</text> </paragraph> <paragraph num="(8)"> <text>Speed reading.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Pro Bono Dental and Dental Hygiene Services."> <paragraph num="A."> <text>Beginning on the effective date of this regulation dentists or dental hygienists may receive continuing education credit for providing volunteer pro bono dental and dental hygiene services within the State as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>A dentist or dental hygienist may provide volunteer pro bono care at a Board-approved program that:</text> <paragraph num="(1)"> <text>Is a non-profit entity or event; and</text> </paragraph> <paragraph num="(2)"> <text>Provides substantial pro bono dental services to the indigent or dentally underserved populations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>With the exception of food, lodging, and parking fees, a dentist or dental hygienist may not receive direct or indirect remuneration of any kind, including but not limited to remuneration for materials purchased or used.</text> </paragraph> <paragraph num="D."> <text>With the exception of those pro bono services provided at a dentist’s or dental hygienist’s office as outlined in §E of this regulation, the program shall require a dentist or dental hygienist to sign in and sign out daily upon commencement and termination of the provision of services.</text> </paragraph> <paragraph num="E."> <text>A dentist or dental hygienist may provide pro bono services for continuing education credit at the dentist’s or dental hygienist’s office:</text> <paragraph num="(1)"> <text>If the patient is referred to the dentist or dental hygienist by a Board-approved nonprofit entity that provides substantial pro bono dental services to the indigent or dentally underserved populations; and</text> </paragraph> <paragraph num="(2)"> <text>If the Board provides prior approval of the provision of the dental or dental hygiene services.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Continuing education credit shall be calculated based on the time a dentist or dental hygienist has actually dedicated to the performance of dental or dental hygiene services.</text> </paragraph> <paragraph num="G."> <text>Continuing education credit shall be calculated at the ratio of 1 continuing education credit for each 60 minutes of patient services.</text> </paragraph> <paragraph num="H."> <text>Credit may not be provided for missed appointments.</text> </paragraph> <paragraph num="I."> <text>Board-approved nonprofit entities that provide substantial dental services for continuing education credit shall:</text> <paragraph num="(1)"> <text>Retain patient records;</text> </paragraph> <paragraph num="(2)"> <text>Retain documentation of all pro bono assignments and the hours of service provided; and</text> </paragraph> <paragraph num="(3)"> <text>Provide the records and a copy of the assignments and the hours of service provided to the Board upon request.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Board may revoke the approval status of any nonprofit entity that fails to cooperate with the Board.</text> </paragraph> <paragraph num="K."> <text>A dental hygienist who provides pro bono dental services shall work under the direct supervision of a dentist.</text> </paragraph> <paragraph num="L."> <text>A dentist or dental hygienist that is employed by a nonprofit entity that provides substantial pro bono dental services to the indigent or dentally underserved populations may not obtain credit for pro bono services at the entity at which the dentist or dental hygienist is employed, but may receive credit for qualified pro bono services at other nonprofit entities.</text> </paragraph> <paragraph num="M."> <text>A dentist who is a Board-recognized specialist and who has announced a specialization shall limit the pro bono services exclusively to the announced special areas.</text> </paragraph> <paragraph num="N."> <text>In accordance with COMAR 10.44.12, a dentist may administer general anesthesia or sedation only with the appropriate Board permit issued for the specific practice location at which the dentist wishes to administer general anesthesia or sedation.</text> </paragraph> <paragraph num="O."> <text>A dental hygienist may administer local anesthesia by infiltration only with the appropriate Board recognition.</text> </paragraph> <paragraph num="P."> <text>A dentist and dental hygienist who provide pro bono dental services shall:</text> <paragraph num="(1)"> <text>Maintain proof of such services for at least 5 years on a Board-approved form; and</text> </paragraph> <paragraph num="(2)"> <text>Provide documentation of the services to the Board on request.</text> </paragraph> </paragraph> <paragraph num="Q."> <text>A dentist or dental hygienist who fails to maintain accurate and complete records of services rendered may not receive continuing education credit for those services.</text> </paragraph> <paragraph num="R."> <text>A dentist shall use a Board-approved form for patients with clear instructions for any follow-up care.</text> </paragraph> <paragraph num="S."> <text>A dentist or a dental hygienist under a formal or informal Board order or agreement that provides for the provision of pro bono services may not receive continuing education credit for the provision of the pro bono services.</text> </paragraph> <paragraph num="T."> <text>Failure to comply with the provisions of this regulation constitutes unprofessional conduct.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Automatically Approved Sponsors."> <paragraph num="A."> <text>The Board approves for credit any course or program that:</text> <paragraph num="(1)"> <text>Satisfies all eligibility criteria in Regulations .06 and .07 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Is sponsored by any one of the following entities:</text> <paragraph num="(a)"> <text>An accredited dental school;</text> </paragraph> <paragraph num="(b)"> <text>An accredited dental hygiene school;</text> </paragraph> <paragraph num="(c)"> <text>The American Dental Association;</text> </paragraph> <paragraph num="(d)"> <text>The National Dental Association;</text> </paragraph> <paragraph num="(e)"> <text>The American Dental Hygienists' Association;</text> </paragraph> <paragraph num="(f)"> <text>The National Dental Hygiene Association;</text> </paragraph> <paragraph num="(g)"> <text>The American Medical Association;</text> </paragraph> <paragraph num="(h)"> <text>The American Hospital Association;</text> </paragraph> <paragraph num="(i)"> <text>The American Heart Association;</text> </paragraph> <paragraph num="(j)"> <text>The American Red Cross;</text> </paragraph> <paragraph num="(k)"> <text>The American Society of Dentistry for Children;</text> </paragraph> <paragraph num="(l)"> <text>Any American Dental Association recognized specialty society;</text> </paragraph> <paragraph num="(m)"> <text>The Academy of General Dentistry;</text> </paragraph> <paragraph num="(n)"> <text>The Veterans Administration;</text> </paragraph> <paragraph num="(o)"> <text>The United States uniformed services;</text> </paragraph> <paragraph num="(p)"> <text>The U.S. Department of Health and Human Services;</text> </paragraph> <paragraph num="(q)"> <text>The Maryland Department of Health;</text> </paragraph> <paragraph num="(r)"> <text>Any American Medical Association recognized specialty society;</text> </paragraph> <paragraph num="(s)"> <text>The Mid-Atlantic PANDA Coalition; and</text> </paragraph> <paragraph num="(t)"> <text>Any constituent or component organization of the groups in §A(2)(a)—(s) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board approves for credit any course or program that is designed to enhance the licensee’s clinical knowledge and ability to treat dental patients and is approved by any one of the following credentialing agencies:</text> <paragraph num="(1)"> <text>The American Dental Association Commission for Continuing Education Recognition Program (CERP);</text> </paragraph> <paragraph num="(2)"> <text>The Academy of General Dentistry Program Approval for Continuing Education (PACE);</text> </paragraph> <paragraph num="(3)"> <text>The American Association of Dental Boards Accredited Continuing Education Program (ACE); and</text> </paragraph> <paragraph num="(4)"> <text>The American Academy of Dental Hygiene (AADH).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Approval and Rescission of Continuing Education Programs for Sponsors Who Are Not Automatically Approved."> <paragraph num="A."> <text>The Board may approve individual programs of sponsors who are not automatically approved sponsors of continuing education credits under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Applicants meeting the requirements of this chapter, who are not automatically approved to sponsor continuing education programs may apply to the Board at least 90 days before the scheduled program for authorization to sponsor a program.</text> </paragraph> <paragraph num="C."> <text>The Board shall provide the applicant with an application form.</text> </paragraph> <paragraph num="D."> <text>An applicant shall provide the following information on the application which shall be submitted to the Board along with a processing fee as set forth in COMAR 10.44.20:</text> <paragraph num="(1)"> <text>Full name, business address, and contact information of the sponsor;</text> </paragraph> <paragraph num="(2)"> <text>Full name of the program for which approval is sought;</text> </paragraph> <paragraph num="(3)"> <text>A program description;</text> </paragraph> <paragraph num="(4)"> <text>Program objectives;</text> </paragraph> <paragraph num="(5)"> <text>A detailed syllabus of the course;</text> </paragraph> <paragraph num="(6)"> <text>Continuing education hours requested;</text> </paragraph> <paragraph num="(7)"> <text>An overview of any examinations that shall be passed as a condition of program completion; and</text> </paragraph> <paragraph num="(8)"> <text>A sample of the certificate of completion that will be provided to program participants.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the requirements of §D of this regulation, the applicant shall provide the following to the Board regarding the program presenter or speaker:</text> <paragraph num="(1)"> <text>Full name, business address, and contact information;</text> </paragraph> <paragraph num="(2)"> <text>Current curriculum vitae;</text> </paragraph> <paragraph num="(3)"> <text>Educational background and all professional degrees earned;</text> </paragraph> <paragraph num="(4)"> <text>A list of all professional licenses or certifications held;</text> </paragraph> <paragraph num="(5)"> <text>A brief description of any other professional programs taught; and</text> </paragraph> <paragraph num="(6)"> <text>A copy of any public disciplinary orders issued by any health occupational board, including the Maryland Dental Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Board shall give notice to the applicant that the applicant has been approved or disapproved, including a statement whether the number of approved continuing education hours is different from the number requested.</text> </paragraph> <paragraph num="G."> <text>If a program is disapproved, the Board shall advise the applicant of the reasons for disapproval.</text> </paragraph> <paragraph num="H."> <text>An approval of a particular program is an approval of the program and the presenter or speaker of that program.</text> </paragraph> <paragraph num="I."> <text>A sponsor shall resubmit an application and pay a processing fee for approval of the program if:</text> <paragraph num="(1)"> <text>The presenter or speaker changes; or</text> </paragraph> <paragraph num="(2)"> <text>There is a significant change in the course material or course objectives.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Fees for approval of a continuing education program are nonrefundable.</text> </paragraph> <paragraph num="K."> <text>A licensee or certificate holder under a Board order may not present a continuing education course or program during the pendency of their Board order.</text> </paragraph> <paragraph num="L."> <text>A sponsor of a Board-approved continuing education program shall:</text> <paragraph num="(1)"> <text>Maintain records of all attendees for at least 5 years;</text> </paragraph> <paragraph num="(2)"> <text>Provide copies of program attendance to the Board upon request;</text> </paragraph> <paragraph num="(3)"> <text>Provide attendees with an opportunity to complete a program evaluation at the conclusion of the program, which shall be provided to the Board upon request; and</text> </paragraph> <paragraph num="(4)"> <text>Allow the Board to audit the program upon payment of any applicable program fees.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The Board may rescind approval of a continuing education course or program if it determines that:</text> <paragraph num="(1)"> <text>The course or program:</text> <paragraph num="(a)"> <text>Does not meet the requirements of Regulations .06 and .07 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>In the Board’s sole discretion, does not meet its stated objectives; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The sponsor has committed fraud or made other misrepresentations to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Certificates of Completion."> <text>Legible certificates of program completion shall be provided to those who complete the program and shall contain at least:</text> <paragraph num="A."> <text>The full name of the sponsor;</text> </paragraph> <paragraph num="B."> <text>The full name of the program;</text> </paragraph> <paragraph num="C."> <text>The dates of program presentation;</text> </paragraph> <paragraph num="D."> <text>The location of the program, including whether the program was presented electronically;</text> </paragraph> <paragraph num="E."> <text>The number of continuing education hours awarded, which may not exceed those approved by the Board;</text> </paragraph> <paragraph num="F."> <text>The printed name and signature of the presenter or speaker;</text> </paragraph> <paragraph num="G."> <text>A statement that the program is approved by the Board;</text> </paragraph> <paragraph num="H."> <text>The Board’s program approval number; and</text> </paragraph> <paragraph num="I."> <text>A statement that the sponsor maintains responsibility for the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Advanced Clinical Training Programs for a Dentist Licensed in Another State."> <paragraph num="A."> <text>A dentist licensed in another state who does not hold a Maryland dental license and who wishes to participate in an advanced clinical training program of postgraduate training offered as continuing education for licensed dentists shall receive written approval from the Board before participation in the advanced clinical training program as provided in Regulation .10B of this chapter.</text> </paragraph> <paragraph num="B."> <text>At least 45 days before the commencement of an advanced clinical training program of postgraduate training offered as continuing education for licensed dentists, a dentist who is licensed in another state and who is not licensed in Maryland shall apply to the Board for written approval to participate in the advanced clinical training program as provided in Regulation .10A of this chapter.</text> </paragraph> <paragraph num="C."> <text>To qualify to participate in an advanced clinical training program, a dentist who is licensed in another state and who does not hold a Maryland dental license shall hold a degree of Doctor of Dental Surgery or Doctor of Dental Medicine, or the equivalent, from a college or university that is authorized by any state or province of Canada to grant the degree.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Advanced Clinical Training Programs — Application Procedures and Practice Limitations."> <paragraph num="A."> <text>To apply for written approval to participate in an advanced clinical training program offered as continuing education for licensed dentists, a dentist licensed in another state who does not hold a Maryland dental license shall:</text> <paragraph num="(1)"> <text>Apply to the Board on a form approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay a nonrefundable fee to the Board as set forth in COMAR 10.44.20;</text> </paragraph> <paragraph num="(3)"> <text>Submit to the Board a copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="(4)"> <text>Submit documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(5)"> <text>Submit any other pertinent documents or information requested by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>After review of the documentation and other pertinent information provided to the Board, the Board shall provide the applicant with a written notice stating that the application to participate in the advanced clinical training program has been approved or denied.</text> </paragraph> <paragraph num="C."> <text>The Board's approval or denial of an application to participate in an advanced clinical training program shall apply only to the advanced clinical training program for which the applicant has made application.</text> </paragraph> <paragraph num="D."> <text>A dentist whose application to participate in an advanced clinical training program for continuing education has been approved shall be covered by a policy of malpractice insurance during the period in which the dentist participates in the advanced clinical training program.</text> </paragraph> <paragraph num="E."> <text>An individual who is a student of dentistry under Regulation .02B(6)(d) and (f) of this chapter may only practice dentistry in Maryland in accordance with the advanced clinical training program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Examination in Lieu of Continuing Education Requirements."> <paragraph num="A."> <text>Successful completion of a Board-approved examination within the preceding 2-year period may be substituted for continuing education credits.</text> </paragraph> <paragraph num="B."> <text>The Board recognizes successful completion of the following written examinations as equivalent to 30 full hours of continuing education:</text> <paragraph num="(1)"> <text>For dental hygienists only, the North East Regional Board's (NERB) Dental Hygiene Comprehensive Examination;</text> </paragraph> <paragraph num="(2)"> <text>NERB's Simulated Clinical Examinations;</text> </paragraph> <paragraph num="(3)"> <text>Academy of General Dentistry's Fellowship Examination;</text> </paragraph> <paragraph num="(4)"> <text>Examinations leading to recognized specialty boards' Diplomate status;</text> </paragraph> <paragraph num="(5)"> <text>National Board's Part II examination;</text> </paragraph> <paragraph num="(6)"> <text>Central Regional Dental Testing Agency's written examinations;</text> </paragraph> <paragraph num="(7)"> <text>South East Regional Testing Agency's written examinations; or</text> </paragraph> <paragraph num="(8)"> <text>Western Regional Examining Board's written examination.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Audit of Continuing Education Records."> <paragraph num="A."> <text>A dentist or dental hygienist who has completed the continuing education requirements shall attest to the completion on a form supplied by the Board as part of the application for license renewal, reinstatement, or reactivation.</text> </paragraph> <paragraph num="B."> <text>The Board may request verification of compliance with this chapter through inspection of continuing education records maintained by licensees in accordance with Regulation .03A of this chapter.</text> </paragraph> <paragraph num="C."> <text>Except as provided in this regulation, the Board shall audit a percentage of dentists and dental hygienists, selected by the Board for each renewal cycle.</text> </paragraph> <paragraph num="D."> <text>A licensee who receives notice of a continuing education audit shall verify compliance with this chapter by the date specified in the notice and submit to the Board a report of the continuing education hours required for renewal on a form approved by the Board along with the appropriate documentation.</text> </paragraph> <paragraph num="E."> <text>Documentation. A dentist or dental hygienist shall provide to the Board:</text> <paragraph num="(1)"> <text>A certificate of completion for approved courses or programs;</text> </paragraph> <paragraph num="(2)"> <text>Current CPR certification as specified under Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>If applicable, proof of Board-approved pro bono dental or dental hygiene services provided; and</text> </paragraph> <paragraph num="(4)"> <text>If a certificate of completion is not available, satisfactory proof of time spent preparing and presenting table clinics, lectures, articles for publications in dental or medical journals, or attending study clubs, or other meetings involved with performing clinical dentistry.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A dentist or a dental hygienist may request an extension of time to comply with the requirements of this chapter.</text> </paragraph> <paragraph num="G."> <text>A request for an extension of time under §F of this regulation shall:</text> <paragraph num="(1)"> <text>Be made in writing;</text> </paragraph> <paragraph num="(2)"> <text>Detail and document the reasons the licensee was not able to complete the continuing education requirements within the allotted time; and</text> </paragraph> <paragraph num="(3)"> <text>Provide a period of time requested by the licensee to complete the required continuing education.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The grant of an extension and the period of the extension is within the sole discretion of the Board.</text> </paragraph> <paragraph num="I."> <text>A dentist or dental hygienist who requests and is granted an extension of time by the Board shall be audited at the next renewal cycle.</text> </paragraph> <paragraph num="J."> <text>A dentist or dental hygienist granted an extension of time shall attest to completion of continuing education requirements by the end of the extension period.</text> </paragraph> <paragraph num="K."> <text>Failure to submit the required attestation or failure to meet continuing education requirements by the end of the extension period may subject the licensee to disciplinary action.</text> </paragraph> <paragraph num="L."> <text>The Board’s staff shall conduct a preliminary review and evaluation of the documentation submitted to the Board and report their findings to the Board.</text> </paragraph> <paragraph num="M."> <text>After the Board’s review of the submitted documentation, the Board may find one or both of the following:</text> <paragraph num="(1)"> <text>That the dentist or dental hygienist has not met the Board’s continuing education requirements; or</text> </paragraph> <paragraph num="(2)"> <text>That the dentist or dental hygienist has submitted courses or programs that have not been Board-approved.</text> </paragraph> </paragraph> <paragraph num="N."> <text>The Board may require a dentist or a dental hygienist who has not met the Board’s continuing education requirements or who has submitted courses or programs that have not been Board-approved to take additional continuing education courses or programs in order to meet the Board’s continuing education requirements.</text> </paragraph> <paragraph num="O."> <text>Penalties for Violation.</text> <paragraph num="(1)"> <text>A false, misleading, or deceptive statement on a renewal, reinstatement, or reactivation form may constitute unprofessional conduct and may result in disciplinary action against the licensee as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Failure to complete continuing education requirements within the time period specified under Regulation .05 of this chapter or any applicable extension constitutes unprofessional conduct and may result in disciplinary action against the licensee as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Active Military Service."> <text>The Board may waive any or all of the requirements of this chapter for a licensee who is unable to complete the requirements due to the licensee's active military service.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 adopted as an emergency provision effective November 25, 1992 (19:25 Md. R. 2199); adopted permanently effective May 26, 1993 (20:6 Md. R. 581)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 12, 1998 (25:14 Md. R. 1132)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 5, 2004 (30:26 Md. R. 1915)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 recodified to be Regulation .11 and new Regulation .10 adopted effective June 21, 2004 (31:12 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 17, 2006 (33:14 Md. R. 1164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 26, 2009 (36:2 Md. R. 101)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 18, 2011 (38:8 Md. R. 506)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 18, 2013 (40:5 Md. R. 411); March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 13, 2014 (41:20 Md. R. 1112); March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D-1 adopted effective March 18, 2013 (40:5 Md. R. 411)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 3, 2025 (52:4 Md. R. 218</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective October 13, 2014 (41:20 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective October 13, 2014 (41:20 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulations .09—.11 recodified to Regulations .11—.13 and Regulation .13 to be Regulation .15 effective March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed effective March 3, 2025 (52:4 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 repealed and new Regulation .14 adopted effective March 3, 2025 (52:4 Md. R. 218)</annotation> </annotations> </chapter> <chapter num="23" heading="Unprofessional Conduct"> <regulation prefix="Regulation" num=".01" heading="Definition."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Legitimate patient” means a patient who has an existing written dental record or who has one created within 72 hours of the patient's first communication with the dentist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>In this chapter, the following documents are incorporated by reference.</text> <paragraph num="A."> <text>Principles of Ethics and Code of Professional Conduct (American Dental Association, With official advisory opinions revised to September 2016).</text> </paragraph> <paragraph num="B."> <text>Bylaws — Code of Ethics (for Dental Hygienists), (American Dental Hygienists’ Association, June 23, 2014).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Unprofessional or Dishonorable Conduct."> <paragraph num="A."> <text>A dentist, dental hygienist, or dental radiation technologist may not engage in unprofessional or dishonorable conduct.</text> </paragraph> <paragraph num="B."> <text>The following shall constitute unprofessional or dishonorable conduct in the practice of dentistry, dental hygiene, or dental radiation technology:</text> <paragraph num="(1)"> <text>Misrepresenting the following to a patient or the public:</text> <paragraph num="(a)"> <text>The description, chemical composition, or quality of the materials the licensee uses or intends to use; or</text> </paragraph> <paragraph num="(b)"> <text>Methods and techniques the licensee uses or intends to use;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Engaging in conduct which is unbecoming a member of the dental profession;</text> </paragraph> <paragraph num="(3)"> <text>Representing that a dental procedure has been completed when in fact the procedure has not been completed;</text> </paragraph> <paragraph num="(4)"> <text>Permitting or failing to prevent the placement or exposure of dental radiographs by an individual not certified or otherwise qualified to do so;</text> </paragraph> <paragraph num="(5)"> <text>Committing an act of sexual misconduct as described in §C of this regulation;</text> </paragraph> <paragraph num="(6)"> <text>Performing a dental procedure without first obtaining informed consent from the patient or the patient’s legal representative;</text> </paragraph> <paragraph num="(7)"> <text>Willfully and without legal justification, failing to cooperate with a lawful investigation conducted by the Board, which includes, but is not limited to:</text> <paragraph num="(a)"> <text>Furnishing information requested;</text> </paragraph> <paragraph num="(b)"> <text>Complying with a subpoena;</text> </paragraph> <paragraph num="(c)"> <text>Responding to a complaint at the request of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Providing meaningful and timely access to relevant patient records; or</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Committing any other unprofessional or dishonorable act or omission in the practice of dentistry, dental hygiene, or dental radiation technology.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Sexual misconduct of either a verbal or a physical nature shall include, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a patient in the context of a professional evaluation, treatment, procedure, or other service to the client or patient, regardless of the setting in which professional service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a patient under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Requesting sexual favors of a patient;</text> </paragraph> <paragraph num="(4)"> <text>Touching a patient in a sexual manner;</text> </paragraph> <paragraph num="(5)"> <text>Therapeutically unnecessary discussion of sexual matters or other verbal conduct of a sexual nature while treating a patient;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs or videotapes of a patient for sexual purposes;</text> </paragraph> <paragraph num="(7)"> <text>Sexual behavior that would be considered unethical or unprofessional; or</text> </paragraph> <paragraph num="(8)"> <text>The use of a drug on a patient for the purpose of sexual behavior.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Dentists.</text> <paragraph num="(1)"> <text>In addition to the requirements stated in §§A—C of this regulation, a dentist shall comply with the Principles of Ethics and Code of Professional Conduct.</text> </paragraph> <paragraph num="(2)"> <text>It shall constitute unprofessional and dishonorable conduct for a dentist to:</text> <paragraph num="(a)"> <text>Self-prescribe prescription medications except that a dentist may self-prescribe when necessary to order prescription medications for dental office inventory for patient use only;</text> </paragraph> <paragraph num="(b)"> <text>Prescribe prescription medications for individuals who are not legitimate patients;</text> </paragraph> <paragraph num="(c)"> <text>Prescribe prescription medications to legitimate patients other than for therapeutic purposes;</text> </paragraph> <paragraph num="(d)"> <text>Sell, prescribe, trade, give away, or administer a prescription drug for any illegal or illegitimate purpose;</text> </paragraph> <paragraph num="(e)"> <text>Treat family members or staff differently than any other patient by:</text> <paragraph num="(i)"> <text>Not maintaining accurate records of all treatment provided in accordance with COMAR 10.44.30, including financial records and records of all medication prescribed; and</text> </paragraph> <paragraph num="(ii)"> <text>Not adhering to all record retention requirements in accordance with Health General Article, §4-403, Annotated Code of Maryland; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Fail to comply with the requirements of the Prescription Drug Monitoring Program as established in Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland, and COMAR 10.47.07.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Dental Hygienists. In addition to the requirements stated in §§A — C of this regulation, a dental hygienist shall comply with the Bylaws — Code of Ethics (for Dental Hygienists).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Penalties."> <paragraph num="A."> <text>A dentist who violates this chapter is subject to the sanctions enumerated in Health Occupations Article, §4-315(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A dental hygienist who violates this chapter is subject to the sanctions enumerated in Health Occupations Article, §4-315(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A dental radiation technologist who violates this chapter is subject to the sanctions enumerated in COMAR 10.44.19.11A.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 4-205(c)(3), 4-315(a)(16) and (b)(3), and 4-505(a)(2) and (c)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 5, 2001 (28:4 Md. R. 419)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 19, 2004 (31:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended and recodified to be Regulation .03, new Regulation .02 adopted effective September 3, 2001 (28:17 Md. R. 1557)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 6, 2012 (39:15 Md. R. 964)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 14, 2014 (41:7 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 17, 2017 (44:14 Md. R.655)</annotation> </annotations> </chapter> <chapter num="24" heading="Retired Volunteer Licenses"> <regulation prefix="Regulation" num=".01" heading="Use of License."> <text>The license of a retired volunteer dentist or a retired volunteer dental hygienist shall be used only for volunteer services and not for compensation.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifications for a Retired Volunteer License."> <text>To qualify for a retired volunteer dentist's or dental hygienist's license, a dentist or dental hygienist shall:</text> <paragraph num="A."> <text>Be of good moral character;</text> </paragraph> <paragraph num="B."> <text>Have had an active general license to practice dentistry or dental hygiene in Maryland within the past 2 years;</text> </paragraph> <paragraph num="C."> <text>Meet the qualifications otherwise required by Health Occupations Article, Title 4, Annotated Code of Maryland, for an active general license to practice dentistry or dental hygiene in the State, except that the North East Regional Board examination requirements are waived by the Board;</text> </paragraph> <paragraph num="D."> <text>Complete the continuing education requirements for an active general license to practice dentistry or dental hygiene in the State; and</text> </paragraph> <paragraph num="E."> <text>Provide dental or dental hygiene services as set forth in Regulation .06 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for a Retired Volunteer License."> <text>To apply for a retired volunteer license to practice dentistry or dental hygiene, a dentist or dental hygienist shall submit:</text> <paragraph num="A."> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that the “photograph is a true photograph of me”;</text> </paragraph> <paragraph num="C."> <text>A certified letter with a raised embossed seal from the licensing authority of each state in which the applicant holds an active dental or dental hygiene license, or ever held an active dental or dental hygiene license, indicating that the license is or was in good standing and whether the applicant:</text> <paragraph num="(1)"> <text>Is being investigated;</text> </paragraph> <paragraph num="(2)"> <text>Has charges pending against the applicant's license;</text> </paragraph> <paragraph num="(3)"> <text>Has been disciplined; or</text> </paragraph> <paragraph num="(4)"> <text>Has been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="E."> <text>A notarized affidavit stating that the dentist or dental hygienist will donate at least 100 hours of dental or dental hygiene services without compensation;</text> </paragraph> <paragraph num="F."> <text>Evidence that the dentist or dental hygienist is covered by malpractice insurance as set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="G."> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="H."> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Malpractice Insurance Requirement for Initial Licensure and Renewal."> <paragraph num="A."> <text>An applicant for a retired volunteer dentist's or dental hygienist's license and an applicant for the renewal of a retired volunteer dentist's or dental hygienist's license shall be covered by malpractice insurance.</text> </paragraph> <paragraph num="B."> <text>If the malpractice insurance consists of a personal policy of malpractice insurance, the dentist or dental hygienist shall provide the Board with evidence of the insurance which shall consist of:</text> <paragraph num="(1)"> <text>The name of the insurance provider;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and telephone number of the insured's agent, or if the insured has no agent, the address and telephone number of the insurance provider;</text> </paragraph> <paragraph num="(3)"> <text>The policy number;</text> </paragraph> <paragraph num="(4)"> <text>The amounts of coverage; and</text> </paragraph> <paragraph num="(5)"> <text>The expiration date of the policy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the malpractice insurance is provided from or through the institution at which the applicant is to provide volunteer services, the dentist or dental hygienist shall provide the Board with evidence of the insurance which shall consist of:</text> <paragraph num="(1)"> <text>The name of the insurance provider;</text> </paragraph> <paragraph num="(2)"> <text>The amounts of coverage;</text> </paragraph> <paragraph num="(3)"> <text>The expiration date of the policy or coverage; and</text> </paragraph> <paragraph num="(4)"> <text>A letter from the institution verifying the intent of the institution to provide malpractice insurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensure of Retired Volunteer Dentists and Dental Hygienists."> <paragraph num="A."> <text>A dentist or dental hygienist shall be granted a retired volunteer dentist's or dental hygienist's license if the dentist or dental hygienist:</text> <paragraph num="(1)"> <text>Meets the qualifications for licensure as a retired volunteer dentist or dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>Is covered by a personal policy of malpractice insurance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist or dental hygienist shall be granted a retired volunteer dentist's or dental hygienist's license that is site-specific to the institution at which the dentist or dental hygienist is to provide the volunteer services if the dentist or dental hygienist:</text> <paragraph num="(1)"> <text>Meets the qualifications for licensure as a retired volunteer dentist or dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>Is covered with malpractice insurance from or through the institution at which the dentist or dental hygienist is to provide volunteer services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dentist or dental hygienist who has been granted a site-specific retired volunteer dentist's or dental hygienist's license shall practice dentistry or dental hygiene only at the institution named on the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Scope of Practice."> <paragraph num="A."> <text>A dentist or dental hygienist with a retired volunteer license to practice dentistry or dental hygiene in the State shall practice only:</text> <paragraph num="(1)"> <text>In a dental office;</text> </paragraph> <paragraph num="(2)"> <text>In a dental clinic;</text> </paragraph> <paragraph num="(3)"> <text>In an ambulatory care facility;</text> </paragraph> <paragraph num="(4)"> <text>In a hospital; or</text> </paragraph> <paragraph num="(5)"> <text>For an entity providing medical care to the poor, the elderly, or handicapped that is operated:</text> <paragraph num="(a)"> <text>By the State;</text> </paragraph> <paragraph num="(b)"> <text>By a local government;</text> </paragraph> <paragraph num="(c)"> <text>By a bona fide charitable organization; or</text> </paragraph> <paragraph num="(d)"> <text>In any other setting approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist or dental hygienist with a retired volunteer license may not receive compensation for practicing dentistry or dental hygiene in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Expiration Date of Licenses."> <text>A retired volunteer license to practice dentistry and a retired volunteer license to practice dental hygiene expire on June 30 of the second year following the effective date of the license.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Renewal of Licenses."> <text>Before a retired volunteer license to practice dentistry or dental hygiene expires, the licensee may renew it for an additional term if the licensee:</text> <paragraph num="A."> <text>Submits a completed renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>Completes the continuing education requirements for an active general license to practice dentistry or dental hygiene in the State;</text> </paragraph> <paragraph num="C."> <text>Submits proof satisfactory to the Board that the dentist has donated at least 100 hours of dental services, or that the dental hygienist has donated at least 100 hours of dental hygiene services, without compensation;</text> </paragraph> <paragraph num="D."> <text>Provides evidence that the dentist or dental hygienist is covered by malpractice insurance as set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="E."> <text>Submits a copy of the licensee's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="F."> <text>Submits documentation of change of name if the name on any of the documents submitted to the Board differs from the licensee's name; and</text> </paragraph> <paragraph num="G."> <text>Submits any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Surrender of License."> <paragraph num="A."> <text>A dentist or a dental hygienist who has been granted a site-specific retired volunteer dentist's or dental hygienist's license shall immediately surrender the license to the Board when the dentist or dental hygienist ceases to:</text> <paragraph num="(1)"> <text>Provide volunteer dental or dental hygiene services at the institution named on the license; or</text> </paragraph> <paragraph num="(2)"> <text>Be covered by malpractice insurance from or through the institution named on the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist or a dental hygienist who has been granted a retired volunteer dentist's or dental hygienist's license that is not site-specific shall immediately surrender the license to the Board when the dentist or dental hygienist ceases to be covered by malpractice insurance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Fees."> <text>There is no fee for an initial retired volunteer license to practice dentistry or dental hygiene, and there is no fee for the renewal of a retired volunteer license to practice dentistry or dental hygiene.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Violations."> <text>Violations of this chapter pertaining to the use of a retired volunteer license constitute unprofessional conduct and may result in disciplinary action against the licensee as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article,§§4-101, 4-302, 4-304, and 4-308, Annotated Code of Maryland; Ch. 237, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 25, 2001 (28:12 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 repealed and new Regulations .01—.08 adopted effective December 11, 2003 (30:24 Md. R. 1743)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 18, 2005 (32:14 Md. R. 1276)</annotation> </annotations> </chapter> <chapter num="25" heading="Compelling Public Purpose"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-205; State Government Article, §10-617(h)(3); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 24, 2001 (28:25 Md. R. 2192)</annotation> </annotations> </chapter> <chapter num="26" heading="Volunteer Licenses"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>The license of a volunteer dentist or a volunteer dental hygienist shall be used for volunteer services and not for compensation.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifications — Dentist Who Has Passed a Regional Board."> <text>To qualify for a volunteer dentist's license, a dentist who has passed a regional board as defined in Health Occupations Article, §4-306(a)(3), Annotated Code of Maryland, shall:</text> <paragraph num="A."> <text>Be of good moral character;</text> </paragraph> <paragraph num="B."> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="C."> <text>Hold a Degree of Doctor of Dental Surgery, Doctor of Dental Medicine, or the equivalent from a college or university that is:</text> <paragraph num="(1)"> <text>Authorized by any state or province of Canada to grant the degree; and</text> </paragraph> <paragraph num="(2)"> <text>Recognized by the Board as:</text> <paragraph num="(a)"> <text>Requiring adequate preprofessional collegiate training; and</text> </paragraph> <paragraph num="(b)"> <text>Maintaining an acceptable course of dental instruction;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Pass the NERB dental written examinations;</text> </paragraph> <paragraph num="E."> <text>Pass the Maryland Jurisprudence Examination on the Maryland State Dental Law;</text> </paragraph> <paragraph num="F."> <text>Hold an active license to practice dentistry in another state or in the District of Columbia;</text> </paragraph> <paragraph num="G."> <text>Meet the qualifications otherwise required for a general license to practice dentistry by Health Occupations Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="H."> <text>Complete the continuing education requirements for an active general license to practice dentistry; and</text> </paragraph> <paragraph num="I."> <text>Provide dental services as set forth in Regulation .11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications — Dentist Who Has Not Passed a Regional Board."> <paragraph num="A."> <text>To qualify for a volunteer dentist's license, a dentist who has not passed a regional board shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Hold a Degree of Doctor of Dental Surgery, Doctor of Dental Medicine, or the equivalent from a college or university that is:</text> <paragraph num="(a)"> <text>Authorized by any state or province of Canada to grant the degree; and</text> </paragraph> <paragraph num="(b)"> <text>Recognized by the Board as:</text> <paragraph num="(i)"> <text>Requiring adequate preprofessional collegiate training; and</text> </paragraph> <paragraph num="(ii)"> <text>Maintaining an acceptable course of dental instruction;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submit a notarized affidavit or other evidence satisfactory to the Board indicating that during the 5 years preceding application the applicant has actively engaged in practicing dentistry for at least 850 hours;</text> </paragraph> <paragraph num="(5)"> <text>Pass the NERB dental written examinations;</text> </paragraph> <paragraph num="(6)"> <text>Pass the Maryland Jurisprudence Examination on the Maryland State Dental Law;</text> </paragraph> <paragraph num="(7)"> <text>Hold an active license to practice dentistry in another state or in the District of Columbia;</text> </paragraph> <paragraph num="(8)"> <text>Meet the qualifications otherwise required for a general license to practice dentistry by Health Occupations Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Complete the continuing education requirements for an active general license to practice dentistry; and</text> </paragraph> <paragraph num="(10)"> <text>Provide dental services as set forth in Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If occurring during the 5 years preceding an application, the practice of dentistry in the armed forces, state and federal programs, and intern and residency programs counts toward the required hours of active practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications — Dental Hygienist Who Has Passed a Regional Board."> <text>To qualify for a volunteer dental hygienist's license, a dental hygienist who has passed a regional board as defined in Health Occupations Article, §4-306(a)(3), Annotated Code of Maryland, shall:</text> <paragraph num="A."> <text>Be of good moral character;</text> </paragraph> <paragraph num="B."> <text>Be a graduate of a school for dental hygienists that:</text> <paragraph num="(1)"> <text>Requires at least 2 years of education in an institution of higher education;</text> </paragraph> <paragraph num="(2)"> <text>Is accredited by the American Dental Association Commission on Dental Accreditation; and</text> </paragraph> <paragraph num="(3)"> <text>Is approved by the Board;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Pass the Maryland Jurisprudence Examination on the Maryland State Dental Law;</text> </paragraph> <paragraph num="D."> <text>Hold an active license to practice dental hygiene in another state or in the District of Columbia;</text> </paragraph> <paragraph num="E."> <text>Meet the qualifications otherwise required for a general license to practice dental hygiene by Health Occupations Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="F."> <text>Complete the continuing education requirements for an active general license to practice dental hygiene; and</text> </paragraph> <paragraph num="G."> <text>Provide dental hygiene services as set forth in Regulation .11 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications — Dental Hygienist Who Has Not Passed a Regional Board."> <paragraph num="A."> <text>To qualify for a volunteer dental hygienist's license, a dental hygienist who has not passed a regional board shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be a graduate of a school for dental hygienists that:</text> <paragraph num="(a)"> <text>Requires at least 2 years of education in an institution of higher education;</text> </paragraph> <paragraph num="(b)"> <text>Is accredited by the American Dental Association Commission on Dental Accreditation; and</text> </paragraph> <paragraph num="(c)"> <text>Is approved by the Board;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit a notarized affidavit or other evidence satisfactory to the Board indicating that during the 3 years preceding application the applicant has actively engaged in practicing dental hygiene for at least 150 hours;</text> </paragraph> <paragraph num="(4)"> <text>Pass the Maryland Jurisprudence Examination on the Maryland State Dental Law;</text> </paragraph> <paragraph num="(5)"> <text>Hold an active license to practice dental hygiene in another state or in the District of Columbia;</text> </paragraph> <paragraph num="(6)"> <text>Meet the qualifications otherwise required for a general license to practice dental hygiene by Health Occupations Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Complete the continuing education requirements for an active general license to practice dental hygiene; and</text> </paragraph> <paragraph num="(8)"> <text>Provide dental hygiene services as set forth in Regulation .11 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The practice of dental hygiene in the armed forces, state, or federal programs within the 3 years preceding application counts toward the required hours of active practice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application — Dentist or Dental Hygienist Who Has Passed a Regional Board."> <paragraph num="A."> <text>To apply for a volunteer license to practice dentistry or dental hygiene, a dentist or a dental hygienist who has passed a regional board in accordance with Health Occupations Article, §4-306, Annotated Code of Maryland, shall submit:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="(3)"> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="(4)"> <text>Certified proof of dental or dental hygiene education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead bearing an original signature do not require a raised embossed seal;</text> </paragraph> <paragraph num="(5)"> <text>A certified examination score of a regional board;</text> </paragraph> <paragraph num="(6)"> <text>A certified letter with a raised embossed seal from the dental or dental hygiene licensing authority of each state in which the applicant holds an active dental or dental hygiene license or ever held an active dental or dental hygiene license indicating that the licensee is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined;</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="(8)"> <text>A notarized affidavit stating that the dentist or dental hygienist will donate at least 100 hours of dental or dental hygiene services without compensation;</text> </paragraph> <paragraph num="(9)"> <text>Evidence that the dentist or dental hygienist is covered by malpractice insurance as set forth in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(11)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirement of §A(5) of this regulation that a dentist submit a certified examination score of a regional board, a dentist, if requested by the State Dental Board, shall submit a specific point breakdown by procedure including penalty deductions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Application — Dentist or Dental Hygienist Who Has Not Passed a Regional Board."> <text>To apply for a volunteer license to practice dentistry or dental hygiene, a dentist or a dental hygienist who has not passed a regional board in accordance with Health Occupations Article, §4-306, Annotated Code of Maryland, shall submit:</text> <paragraph num="A."> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement stating that “the photograph is a true photograph of me”;</text> </paragraph> <paragraph num="C."> <text>An original National Board Score Card;</text> </paragraph> <paragraph num="D."> <text>Certified proof of dental or dental hygiene education which contains the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead, bearing an original signature do not require a raised embossed seal;</text> </paragraph> <paragraph num="E."> <text>A certified letter with a raised embossed seal from the dental or dental hygiene licensing authority of each state in which the applicant holds an active dental or dental hygiene license or ever held an active dental or dental hygiene license indicating that the licensee is or was in good standing and that the applicant:</text> <paragraph num="(1)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(2)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(3)"> <text>Has not been disciplined;</text> </paragraph> <paragraph num="(4)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="F."> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="G."> <text>A notarized affidavit stating that the dentist or dental hygienist will donate at least 100 hours of dental or dental hygiene services without compensation;</text> </paragraph> <paragraph num="H."> <text>Evidence that the dentist or dental hygienist is covered by malpractice insurance as set forth in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="I."> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="J."> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Proof of Active Practice of Dentistry or Dental Hygiene."> <paragraph num="A."> <text>In addition to the requirements of Regulation .07 of this chapter, a dentist who has not passed a regional board in accordance with Health Occupations Article, §4-306, Annotated Code of Maryland, shall submit a notarized affidavit or other evidence satisfactory to the Board indicating that during the 5 years preceding application, the dentist has actively engaged in practicing dentistry for at least 850 hours.</text> </paragraph> <paragraph num="B."> <text>In addition to the requirements of Regulation .05 of this chapter, a dental hygienist who has not passed a regional board in accordance with Health Occupations Article, §4-306, Annotated Code of Maryland, shall submit a notarized affidavit or other evidence satisfactory to the Board indicating that during the 3 years preceding application, the dental hygienist has actively engaged in practicing dental hygiene for at least 150 hours.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Malpractice Insurance Requirement for Initial Licensure and Renewal."> <paragraph num="A."> <text>An applicant for a volunteer dentist's or dental hygienist's license, and an applicant for the renewal of a volunteer dentist's or dental hygienist's license, shall be covered by malpractice insurance.</text> </paragraph> <paragraph num="B."> <text>If the malpractice insurance consists of a personal policy of malpractice insurance, the dentist or dental hygienist shall provide the Board with evidence of the insurance which shall consist of:</text> <paragraph num="(1)"> <text>The name of the insurance provider;</text> </paragraph> <paragraph num="(2)"> <text>The name, address, and telephone number of the insured's agent, or if the insured has no agent, the address and telephone number of the insurance provider;</text> </paragraph> <paragraph num="(3)"> <text>The policy number;</text> </paragraph> <paragraph num="(4)"> <text>The amounts of coverage; and</text> </paragraph> <paragraph num="(5)"> <text>The expiration date of the policy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the malpractice insurance is provided from or through the institution at which the applicant is to provide volunteer services, the dentist or dental hygienist shall provide the Board with evidence of the insurance which shall consist of:</text> <paragraph num="(1)"> <text>The name of the insurance provider;</text> </paragraph> <paragraph num="(2)"> <text>The amounts of coverage;</text> </paragraph> <paragraph num="(3)"> <text>The expiration date of the policy or coverage; and</text> </paragraph> <paragraph num="(4)"> <text>A letter from the institution verifying the intent of the institution to provide malpractice insurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Licensure of Volunteer Dentists and Dental Hygienists."> <paragraph num="A."> <text>A dentist or dental hygienist shall be granted a volunteer dentist's or dental hygienist's license if the dentist or dental hygienist:</text> <paragraph num="(1)"> <text>Meets the qualifications for licensure as a volunteer dentist or dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>Is covered by a personal policy of malpractice insurance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist or dental hygienist shall be granted a volunteer dentist's or dental hygienist's license that is site-specific to the institution at which the dentist or dental hygienist is to provide the volunteer services if the dentist or dental hygienist:</text> <paragraph num="(1)"> <text>Meets the qualifications for licensure as a volunteer dentist or dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>Is covered with malpractice insurance from or through the institution at which the dentist or dental hygienist is to provide volunteer services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dentist or dental hygienist who has been granted a site-specific volunteer dentist's or dental hygienist's license shall practice dentistry or dental hygiene only at the institution named on the license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Scope of Practice."> <paragraph num="A."> <text>A dentist or dental hygienist with a volunteer license to practice dentistry or dental hygiene in the State shall practice only:</text> <paragraph num="(1)"> <text>In a dental office;</text> </paragraph> <paragraph num="(2)"> <text>In a dental clinic;</text> </paragraph> <paragraph num="(3)"> <text>In an ambulatory care facility;</text> </paragraph> <paragraph num="(4)"> <text>In a hospital; or</text> </paragraph> <paragraph num="(5)"> <text>For an entity providing medical care to the poor, the elderly, or handicapped that is operated:</text> <paragraph num="(a)"> <text>By the State;</text> </paragraph> <paragraph num="(b)"> <text>By a local government;</text> </paragraph> <paragraph num="(c)"> <text>By a bona fide charitable organization; or</text> </paragraph> <paragraph num="(d)"> <text>In any other setting approved by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Expiration Date of Licenses."> <text>A volunteer license to practice dentistry and a volunteer license to practice dental hygiene expire on June 30 of the second year following the effective date of the license.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Renewal of Licenses."> <text>Before a volunteer license to practice dentistry or dental hygiene expires, the licensee may renew it for an additional term if the licensee:</text> <paragraph num="A."> <text>Submits a completed renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="B."> <text>Completes the continuing education requirements for an active general license to practice dentistry or dental hygiene in the State;</text> </paragraph> <paragraph num="C."> <text>Submits proof satisfactory to the Board that the dentist or dental hygienist has donated at least 100 hours of dental or dental hygiene services without compensation;</text> </paragraph> <paragraph num="D."> <text>Submits evidence that the dentist or dental hygienist is covered by malpractice insurance as set forth in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="E."> <text>Submits documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="F."> <text>Submits any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Surrender of License."> <paragraph num="A."> <text>A dentist or a dental hygienist who has been granted a site-specific volunteer dentist or dental hygienist's license shall immediately surrender the license to the Board if the dentist or dental hygienist ceases to:</text> <paragraph num="(1)"> <text>Provide volunteer dental or dental hygiene services at the institution named on the license; or</text> </paragraph> <paragraph num="(2)"> <text>Be covered by malpractice insurance from or through the institution named on the license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist or a dental hygienist who has been granted a volunteer dentist's or dental hygienist's license that is not site-specific shall immediately surrender the license to the Board if the dentist or dental hygienist ceases to be covered by malpractice insurance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Fees."> <text>There is no fee for an initial volunteer license to practice dentistry or dental hygiene, and there is no fee for the renewal of a volunteer license to practice dentistry or dental hygiene.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Violations."> <text>Violations of this chapter pertaining to the use of a volunteer license constitute unprofessional conduct and may result in disciplinary action against the licensee as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-101, 4-302, 4-304, and 4-308, Annotated Code of Maryland;Ch. 237, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 11, 2003 (30:24 Md. R. 1743)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 16, 2004 (31:16 Md. R. 1256)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 18, 2005 (32:14 Md. R. 1276)</annotation> </annotations> </chapter> <chapter num="27" heading="Dental Hygiene Practice — General Supervision — Private Office"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the practice of dental hygiene in a private dental office. The practice of dental hygiene in a facility is governed by COMAR 10.44.21.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definition."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “General supervision” means the supervision of a dental hygienist by a dentist in a private dental office where the dentist may or may not be present when the dental hygienist performs the dental hygiene procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Supervision Requirements in a Private Dental Office."> <text>While it is effective, a general license to practice dental hygiene issued under Health Occupations Article, Title 4, Annotated Code of Maryland, authorizes the licensee to practice dental hygiene under the general supervision of a licensed dentist in a private dental office pursuant to the provisions of Health Occupations Article, §4-308(i), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Operating under General Supervision in a Private Dental Office."> <paragraph num="A."> <text>In addition to the requirements contained in Health Occupations Article, §4-308(l), Annotated Code of Maryland, if a dental hygienist works under general supervision in a private dental office where a dentist is not on the premises while authorized dental hygiene services are provided, the requirements in §§B—F of this regulation shall be met.</text> </paragraph> <paragraph num="B."> <text>Both the private dental office and the dental hygienist shall maintain written documentation of at least 1,500 hours of dental hygiene clinical practice in direct patient care before commencing practice.</text> </paragraph> <paragraph num="C."> <text>Before an appointment, the patient or the custodial parent or legal guardian of a minor or incompetent adult shall:</text> <paragraph num="(1)"> <text>Be informed that a dental hygienist will be providing services previously prescribed by a dentist who will not be on the premises during the appointment; and</text> </paragraph> <paragraph num="(2)"> <text>Consent in writing to receiving the dental hygiene services.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A copy of the signed consent shall be maintained in the patient's record.</text> </paragraph> <paragraph num="E."> <text>The number of unsupervised clinical hours worked by a dental hygienist in any given 3-month period shall be less than 60 percent of the dental hygienist’s total hours worked during that 3-month period. To insure compliance with this provision, the supervising dentist and the dental hygienist shall maintain a written record of the dental hygienist’s total monthly hours worked and the total number of monthly hours worked by the dental hygienist when a dentist was not on the premises.</text> </paragraph> <paragraph num="F."> <text>A supervising dentist may not have more than two dental hygienists working under the dentist's general supervision at any given time, regardless of the number of offices in which the supervising dentist practices dentistry.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties."> <text>A violation of this chapter by a dentist or dental hygienist is unprofessional conduct.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-308, Annotated Code of Maryland; Ch. 221, Acts of 2003</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 11, 2003 (30:24 Md. R. 1743)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective March 3, 2014 (41:4 Md. R. 301)</annotation> </annotations> </chapter> <chapter num="28" heading="Teachers' Licenses for Graduates of United States or Canadian Dental Schools and Schools of Dental Hygiene"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes the requirements for:</text> <paragraph num="(1)"> <text>A teacher's license to practice dentistry for a graduate of a United States or Canadian dental school; and</text> </paragraph> <paragraph num="(2)"> <text>A teacher's license to practice dental hygiene for a graduate of a United States or Canadian school for dental hygienists.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The requirements for a teacher's license to practice dentistry for a graduate of a foreign dental school are set forth in COMAR 10.44.02.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Teacher's License to Practice Dentistry."> <paragraph num="A."> <text>To qualify for a teacher's license to practice dentistry, an applicant shall meet the requirements set forth in Health Occupations Article, §4-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An applicant for a teacher's license to practice dentistry shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement that “the photograph is a true photograph of me” ;</text> </paragraph> <paragraph num="(3)"> <text>Certified proof of dental education with the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead and bearing an original signature do not require a raised embossed seal;</text> </paragraph> <paragraph num="(4)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant holds an active dental license or ever held an active dental license, indicating that the license is or was in good standing, and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Proof satisfactory to the Board that the applicant has at least 5 years of active dental experience;</text> </paragraph> <paragraph num="(6)"> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="(7)"> <text>A letter from the Dean of the college or university in which the applicant is to teach a subject required by the dental school of that college or university:</text> <paragraph num="(a)"> <text>Requesting that the license be issued; and</text> </paragraph> <paragraph num="(b)"> <text>Indicating that the applicant is to be a full-time faculty member;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Documentation of a change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(9)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The practice of dentistry in the armed forces, state and federal programs, and intern and residency programs within the 5 years preceding application shall count toward the required active dental experience.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for Teacher's License to Practice Dental Hygiene."> <paragraph num="A."> <text>To qualify for a teacher's license to practice dental hygiene, an applicant shall meet the requirements set forth in Health Occupations Article, §4-302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>An applicant for a teacher's license to practice dental hygiene shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement that “the photograph is a true photograph of me” ;</text> </paragraph> <paragraph num="(3)"> <text>Certified proof of dental hygiene education with the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead and bearing an original signature do not require a raised embossed seal;</text> </paragraph> <paragraph num="(4)"> <text>A certified letter with a raised embossed seal from the dental hygiene licensing authority of each state in which the applicant holds an active dental hygiene license or ever held an active dental hygiene license, indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Proof satisfactory to the Board that the applicant has at least 5 years of active dental hygiene experience;</text> </paragraph> <paragraph num="(6)"> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="(7)"> <text>A letter from the Dean of the college or university in which the applicant is to teach a subject required by the dental hygiene school or dental school of that college or university:</text> <paragraph num="(a)"> <text>Requesting that the license be issued; and</text> </paragraph> <paragraph num="(b)"> <text>Indicating that the applicant is to be a full-time faculty member;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Documentation of change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(9)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The practice of dental hygiene in the armed forces, state and federal programs, and intern and residency programs within the 5 years preceding application shall count toward the required active dental hygiene experience.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="License to Teach Dentistry at the University of Maryland Dental School."> <paragraph num="A."> <text>A graduate of a United States or Canadian dental school who is not licensed to practice dentistry in another state and who wishes to obtain a teacher's license to teach dentistry at the University of Maryland Dental School, shall meet the requirements set forth in Health Occupations Article, §4-303(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A graduate of a United States or Canadian dental school who is not licensed to practice dentistry in another state and who wishes to apply for a teacher's license to teach dentistry at the University of Maryland Dental School shall submit the following to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A photograph of the applicant not to exceed 3 inches by 3 inches accompanied by a notarized statement that “the photograph is a true photograph of me” ;</text> </paragraph> <paragraph num="(3)"> <text>Certified proof of dental education with the raised embossed school seal certifying its authenticity, except that letters from educational institutions on original letterhead and bearing an original signature do not require a raised embossed seal;</text> </paragraph> <paragraph num="(4)"> <text>A certified letter with a raised embossed seal from the dental licensing authority of each state in which the applicant ever held an active dental license indicating that the license is or was in good standing and that the applicant:</text> <paragraph num="(a)"> <text>Is not being investigated;</text> </paragraph> <paragraph num="(b)"> <text>Does not have charges pending against the applicant's license;</text> </paragraph> <paragraph num="(c)"> <text>Has not been disciplined; and</text> </paragraph> <paragraph num="(d)"> <text>Has not been convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under Health Occupations Article, §4-315, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Proof satisfactory to the Board that the applicant has at least 5 years of clinical dental experience;</text> </paragraph> <paragraph num="(6)"> <text>A copy of the applicant's National Practitioner Data Bank file;</text> </paragraph> <paragraph num="(7)"> <text>A letter from the Dean of the University of Maryland Dental School:</text> <paragraph num="(a)"> <text>Providing the reasons why the Board should waive the requirement that the applicant be licensed in another state; and</text> </paragraph> <paragraph num="(b)"> <text>Indicating that the applicant is to be a full-time faculty member;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Documentation of a change of name if the name on any of the documents submitted to the Board differs from the applicant's name; and</text> </paragraph> <paragraph num="(9)"> <text>Any other documents or information pertinent to licensure required by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Fees."> <paragraph num="A."> <text>The applicant shall submit the fee specified in COMAR 10.44.20 with the application for a teacher's license to practice:</text> <paragraph num="(1)"> <text>Dentistry; or</text> </paragraph> <paragraph num="(2)"> <text>Dental hygiene.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The application fee is nonrefundable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="License Void."> <text>A teacher's license to practice dentistry and a teacher's license to practice dental hygiene in the State are immediately void upon leaving the faculty position.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-302 and 4-303, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 6, 2005 (31:26 Md. R. 1863)</annotation> </annotations> </chapter> <chapter num="29" heading="Nominations and Balloting for Appointments to Board of Dental Examiners"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>In accordance with Health Occupations Article, §4-202, Annotated Code of Maryland, the Governor appoints the dentist and dental hygienist Board members, with the advice of the Secretary of Health, from a list of names submitted to the Governor by the Board. This chapter covers the nomination and balloting process that will result in that list of names. The process of choosing consumer Board members is not covered by this chapter.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>Dental Hygienist.</text> <paragraph num="(a)"> <text>“Dental hygienist” means an individual who, on the date of the mailing of the Board's notice referred to in Regulation .04B(1) of this chapter, holds a current Maryland:</text> <paragraph num="(i)"> <text>General license to practice dental hygiene;</text> </paragraph> <paragraph num="(ii)"> <text>Teacher's license to practice dental hygiene;</text> </paragraph> <paragraph num="(iii)"> <text>Retired volunteer license to practice dental hygiene;</text> </paragraph> <paragraph num="(iv)"> <text>Volunteer license to practice dental hygiene; or</text> </paragraph> <paragraph num="(v)"> <text>Temporary license to practice dental hygiene.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Dental hygienist” does not include an individual who holds a dental hygienist inactive status registration certificate.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Dentist.</text> <paragraph num="(a)"> <text>“Dentist” means an individual who, on the date of the mailing of the Board's notice referred to in Regulation .03B(1) of this chapter, holds a current Maryland:</text> <paragraph num="(i)"> <text>General license to practice dentistry;</text> </paragraph> <paragraph num="(ii)"> <text>Limited license to practice dentistry;</text> </paragraph> <paragraph num="(iii)"> <text>Teacher's license to practice dentistry;</text> </paragraph> <paragraph num="(iv)"> <text>Retired volunteer license to practice dentistry; or</text> </paragraph> <paragraph num="(v)"> <text>Volunteer license to practice dentistry.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Dentist” does not include an individual who holds a dentist inactive status registration certificate.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Electronic mail (e-mail)” means a message sent or received electronically over a computer network.</text> </paragraph> <paragraph num="(5)"> <text>“State dental hygienist organization affiliated with a national organization” means:</text> <paragraph num="(a)"> <text>An affiliation of dental hygienists who have current membership in a common and distinct Maryland dental hygienist organization or association that is committed to serving generally accepted interests in dental hygiene;</text> </paragraph> <paragraph num="(b)"> <text>An affiliation that is formed pursuant to the laws of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>A constituent organization of a national dental hygienist organization that is:</text> <paragraph num="(i)"> <text>Committed to serving generally accepted interests in dental hygiene; and</text> </paragraph> <paragraph num="(ii)"> <text>Formed pursuant to the laws of the state in which it was formed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“State dental organization affiliated with a national organization” means:</text> <paragraph num="(a)"> <text>An affiliation of dentists who have current membership in a common and distinct Maryland dental organization or association that is committed to serving generally accepted interests in dentistry;</text> </paragraph> <paragraph num="(b)"> <text>An affiliation that is formed pursuant to the laws of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>A constituent organization of a national dental organization which is:</text> <paragraph num="(i)"> <text>Committed to serving generally accepted interests in dentistry; and</text> </paragraph> <paragraph num="(ii)"> <text>Formed pursuant to the laws of the state in which it was formed.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notice to Fill Vacancies for Dentist Board Members."> <paragraph num="A."> <text>General. If there are one or more dentist vacancies on the Board, the Board shall hold an annual election to elect nominees to fill the dentist vacancies.</text> </paragraph> <paragraph num="B."> <text>Notice.</text> <paragraph num="(1)"> <text>The Board shall send notice of the election referred to in §A of this regulation by regular mail to:</text> <paragraph num="(a)"> <text>Each dentist to the last known address on file with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Each properly registered State dental organization affiliated with a national organization, to the address known to the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice referred to in §B(1) of this regulation shall:</text> <paragraph num="(a)"> <text>Advise the recipient of the:</text> <paragraph num="(i)"> <text>Number of vacancies that exist on the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>Terms of office for each vacancy;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Solicit nominations for each vacancy;</text> </paragraph> <paragraph num="(c)"> <text>State that a nomination petition form may be requested from the Board;</text> </paragraph> <paragraph num="(d)"> <text>State the date by which the completed nomination petition form shall be returned to the Board;</text> </paragraph> <paragraph num="(e)"> <text>State that a dentist may vote for a single candidate in the election;</text> </paragraph> <paragraph num="(f)"> <text>State the dates at which time voting by e-mail shall be permitted;</text> </paragraph> <paragraph num="(g)"> <text>State that in lieu of an e-mail ballot a dentist may request a paper ballot from the Board which shall be completed and submitted by a certain date; and</text> </paragraph> <paragraph num="(h)"> <text>Advise the recipient that the results of the balloting will be posted on the Board's website.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the notice mailed by regular mail described in §B of this regulation, the Board or its designee may send an e-mail notice of the election to each dentist to the last known e-mail address on file with the Board.</text> </paragraph> <paragraph num="D."> <text>The e-mail notice described in §C of this regulation shall contain the information described in §B(2) of this regulation.</text> </paragraph> <paragraph num="E."> <text>Nominations — Criteria.</text> <paragraph num="(1)"> <text>Candidates.</text> <paragraph num="(a)"> <text>A candidate's name may appear on the ballot only once.</text> </paragraph> <paragraph num="(b)"> <text>A State dental organization affiliated with a national organization shall only nominate a candidate who is a member of the organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Dentist.</text> <paragraph num="(a)"> <text>A dentist may not nominate more than one candidate.</text> </paragraph> <paragraph num="(b)"> <text>A dentist may be both a petitioner and a candidate.</text> </paragraph> <paragraph num="(c)"> <text>A dentist who is a petitioner but not a candidate is counted as one of the ten dentists who support the nomination.</text> </paragraph> <paragraph num="(d)"> <text>A dentist who is a petitioner and a candidate is not counted as one of the ten dentists who support the nomination.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Dentist and a State Dental Organization Affiliated with a National Organization.</text> <paragraph num="(a)"> <text>A dentist and a State dental organization affiliated with a national organization may nominate a candidate to fill a dentist vacancy on the Board.</text> </paragraph> <paragraph num="(b)"> <text>A dentist or a State dental organization affiliated with a national organization may not nominate more than one candidate.</text> </paragraph> <paragraph num="(c)"> <text>If a dentist or a State dental organization affiliated with a national organization nominates more than one candidate, each Board-approved nomination petition form submitted by the dentist or State dental organization affiliated with a national organization is invalid.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Nomination Petition Form. The Board-approved nomination petition form referred to in §B(2)(c) of this regulation shall:</text> <paragraph num="(1)"> <text>Include:</text> <paragraph num="(a)"> <text>The candidate's name;</text> </paragraph> <paragraph num="(b)"> <text>The candidate's address on file with the Board;</text> </paragraph> <paragraph num="(c)"> <text>The candidate's license number on file with the Board;</text> </paragraph> <paragraph num="(d)"> <text>The names of the petitioners; and</text> </paragraph> <paragraph num="(e)"> <text>The license numbers of the petitioners on file with the Board;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be signed:</text> <paragraph num="(a)"> <text>By the candidate;</text> </paragraph> <paragraph num="(b)"> <text>By the petitioner;</text> </paragraph> <paragraph num="(c)"> <text>If the petitioner is a State dental organization affiliated with a national organization, by its:</text> <paragraph num="(i)"> <text>President;</text> </paragraph> <paragraph num="(ii)"> <text>Executive director; or</text> </paragraph> <paragraph num="(iii)"> <text>Administrator; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>By ten dentists who support the nomination; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include on separate pages, not greater than 8-1/2 inches wide by 11 inches in length, and not exceeding two pages of 12-point type:</text> <paragraph num="(a)"> <text>The candidate's biographical information;</text> </paragraph> <paragraph num="(b)"> <text>The candidate's resume; or</text> </paragraph> <paragraph num="(c)"> <text>The candidate's curriculum vitae.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Board-approved nomination petition forms for dentists and for State dental organizations affiliated with a national organization shall be available from the Board upon request.</text> </paragraph> <paragraph num="H."> <text>Filing of Nomination Petition Form.</text> <paragraph num="(1)"> <text>The petitioner shall deliver the original nomination petition form and supporting documents to the offices of the Board:</text> <paragraph num="(a)"> <text>On or before the date specified in the Board's notice; and</text> </paragraph> <paragraph num="(b)"> <text>During normal business hours.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not accept the filing of any document by:</text> <paragraph num="(a)"> <text>Electronic facsimile transmittal; or</text> </paragraph> <paragraph num="(b)"> <text>E-mail.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A nomination petition form is invalid if:</text> <paragraph num="(a)"> <text>It is received by the Board after the date specified in the Board's notice, regardless of the date of postmark; or</text> </paragraph> <paragraph num="(b)"> <text>It does not otherwise meet the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A State dental organization affiliated with a national organization shall be properly registered with the Board to nominate a candidate.</text> </paragraph> <paragraph num="J."> <text>Posting of Candidates.</text> <paragraph num="(1)"> <text>The Board shall post the names and the biographical information, resumes, or curriculum vitae of the candidates on its website.</text> </paragraph> <paragraph num="(2)"> <text>Biographical information, resumes, or curriculum vitae that do not meet the requirements of §F(3) of this regulation may not be posted on the Board's website.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Notice to Fill Vacancies for Dental Hygienist Board Members."> <paragraph num="A."> <text>General. If there are one or more dental hygienist vacancies on the Board, the Board shall hold an annual election to elect nominees to fill the dental hygienist vacancies.</text> </paragraph> <paragraph num="B."> <text>Notice.</text> <paragraph num="(1)"> <text>The Board shall send notice of the election referred to in §A of this regulation by regular mail to:</text> <paragraph num="(a)"> <text>Each dental hygienist to the last known address on file with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Each properly registered State dental hygienist organization affiliated with a national organization, to the address known to the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice referred to in §B(1) of this regulation shall:</text> <paragraph num="(a)"> <text>Advise the recipient of the:</text> <paragraph num="(i)"> <text>Number of vacancies that exist on the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>Terms of office for each vacancy;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Solicit nominations for each vacancy;</text> </paragraph> <paragraph num="(c)"> <text>State that a nomination petition form may be requested from the Board;</text> </paragraph> <paragraph num="(d)"> <text>State the date by which the completed nomination petition form shall be returned to the Board;</text> </paragraph> <paragraph num="(e)"> <text>State that a dental hygienist may vote for a single candidate in the election;</text> </paragraph> <paragraph num="(f)"> <text>State the dates at which time voting by e-mail shall be permitted;</text> </paragraph> <paragraph num="(g)"> <text>State that in lieu of an e-mail ballot a dental hygienist may request a paper ballot from the Board which shall be completed and submitted by a certain date; and</text> </paragraph> <paragraph num="(h)"> <text>Advise the recipient that the results of the balloting will be posted on the Board's website.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the notice mailed by regular mail described in §B of this regulation, the Board or its designee may send an e-mail notice of the election to each dental hygienist to the last known e-mail address on file with the Board.</text> </paragraph> <paragraph num="D."> <text>The e-mail notice described in §C of this regulation shall contain the information described in §B(2) of this regulation.</text> </paragraph> <paragraph num="E."> <text>Nominations-Criteria.</text> <paragraph num="(1)"> <text>Candidates.</text> <paragraph num="(a)"> <text>A candidate's name may appear on the ballot only once.</text> </paragraph> <paragraph num="(b)"> <text>A State dental hygienist organization affiliated with a national organization shall only nominate a candidate who is a member of the organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Dental Hygienist.</text> <paragraph num="(a)"> <text>A dental hygienist may not nominate more than one candidate.</text> </paragraph> <paragraph num="(b)"> <text>A dental hygienist may be both a petitioner and a candidate.</text> </paragraph> <paragraph num="(c)"> <text>A dental hygienist who is a petitioner but not a candidate is counted as one of the ten dental hygienists who support the nomination.</text> </paragraph> <paragraph num="(d)"> <text>A dental hygienist who is a petitioner and a candidate is not counted as one of the ten dental hygienists who support the nomination.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Dental Hygienists and a State Dental Hygienist Organization Affiliated with a National Organization.</text> <paragraph num="(a)"> <text>A dental hygienist and a State dental hygienist organization affiliated with a national organization may nominate a candidate to fill a dental hygienist vacancy on the Board.</text> </paragraph> <paragraph num="(b)"> <text>A dental hygienist or a State dental hygienist organization affiliated with a national organization may not nominate more than one candidate.</text> </paragraph> <paragraph num="(c)"> <text>If a dental hygienist or State dental hygienist organization affiliated with a national organization nominates more than one candidate, each Board-approved nomination petition form submitted by the dental hygienist or State dental hygienist organization affiliated with a national organization is invalid.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Nomination Petition Form. The Board-approved nomination petition form referred to in §B(2)(d) of this regulation shall:</text> <paragraph num="(1)"> <text>Include:</text> <paragraph num="(a)"> <text>The candidate's name;</text> </paragraph> <paragraph num="(b)"> <text>The candidate's address on file with the Board;</text> </paragraph> <paragraph num="(c)"> <text>The candidate's license number on file with the Board;</text> </paragraph> <paragraph num="(d)"> <text>The names of the petitioners; and</text> </paragraph> <paragraph num="(e)"> <text>The license numbers of the petitioners on file with the Board;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be signed:</text> <paragraph num="(a)"> <text>By the candidate;</text> </paragraph> <paragraph num="(b)"> <text>By the petitioner;</text> </paragraph> <paragraph num="(c)"> <text>If the petitioner is a State dental hygienist organization affiliated with a national organization, by its:</text> <paragraph num="(i)"> <text>President;</text> </paragraph> <paragraph num="(ii)"> <text>Executive director; or</text> </paragraph> <paragraph num="(iii)"> <text>Administrator; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>By ten dental hygienists who support the nomination; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include on separate pages, not greater than 8-1/2 inches wide by 11 inches in length, and not exceeding two pages of 12-point type:</text> <paragraph num="(a)"> <text>The candidate's biographical information;</text> </paragraph> <paragraph num="(b)"> <text>The candidate's resume; or</text> </paragraph> <paragraph num="(c)"> <text>The candidate's curriculum vitae.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Board-approved nomination petition forms for dental hygienists and dental hygienist organizations affiliated with a national organization shall be available from the Board upon request.</text> </paragraph> <paragraph num="H."> <text>Filing of Nomination Petition Form.</text> <paragraph num="(1)"> <text>The petitioner shall deliver the original nomination petition form and supporting documents to the offices of the Board:</text> <paragraph num="(a)"> <text>On or before the date specified in the notice; and</text> </paragraph> <paragraph num="(b)"> <text>During normal business hours.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not accept the filing of any document by:</text> <paragraph num="(a)"> <text>Electronic facsimile transmittal; or</text> </paragraph> <paragraph num="(b)"> <text>E-mail.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A nomination petition form is invalid if:</text> <paragraph num="(a)"> <text>It is received by the Board after the date specified in the Board's notice, regardless of the date of postmark; or</text> </paragraph> <paragraph num="(b)"> <text>It does not otherwise meet the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A State dental hygienist organization affiliated with a national organization shall be properly registered with the Board to nominate a candidate.</text> </paragraph> <paragraph num="J."> <text>Posting of Candidates.</text> <paragraph num="(1)"> <text>The Board shall post the names and the biographical information, resumes, or curriculum vitae of the candidates on its website.</text> </paragraph> <paragraph num="(2)"> <text>Biographical information, resumes, or curriculum vitae that do not meet the requirements of §F(3) of this regulation may not be posted on the Board's website.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Registration of Organizations."> <paragraph num="A."> <text>A State dental organization affiliated with a national organization or a State dental hygienist organization affiliated with a national organization that wishes to nominate candidates for membership on the Board shall register with the Board on a form approved by the Board.</text> </paragraph> <paragraph num="B."> <text>Registration Form.</text> <paragraph num="(1)"> <text>A registration form shall include:</text> <paragraph num="(a)"> <text>A current Certificate of Status issued by the State Department of Assessments and Taxation;</text> </paragraph> <paragraph num="(b)"> <text>A certified copy of the State dental organization's or the State dental hygienist organization's bylaws;</text> </paragraph> <paragraph num="(c)"> <text>A certified copy of the national organization's bylaws; and</text> </paragraph> <paragraph num="(d)"> <text>Proof that the State dental organization or the State dental hygienist organization is a constituent organization of the national organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A completed registration form shall be delivered to the offices of the Board:</text> <paragraph num="(a)"> <text>On or before the date specified in the Board's notice; and</text> </paragraph> <paragraph num="(b)"> <text>During normal business hours.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A completed registration form is invalid if:</text> <paragraph num="(a)"> <text>It is received by the Board after the date specified in the Board's notice, regardless of the date of postmark;</text> </paragraph> <paragraph num="(b)"> <text>It is incomplete; or</text> </paragraph> <paragraph num="(c)"> <text>It does not meet the requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Registration forms from a State dental organization affiliated with a national organization or a State dental hygienist organization affiliated with a national organization shall:</text> <paragraph num="(a)"> <text>Be signed by its:</text> <paragraph num="(i)"> <text>President;</text> </paragraph> <paragraph num="(ii)"> <text>Executive director; or</text> </paragraph> <paragraph num="(iii)"> <text>Administrator; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Contain an affidavit from its president, executive director, or administrator that states: “I solemnly affirm under penalties of perjury and upon personal knowledge that the contents of the foregoing paper and all attachments are true.”</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If a registration form does not meet the requirements of this chapter, the Board shall:</text> <paragraph num="(a)"> <text>Return the form to the organization by regular mail; and</text> </paragraph> <paragraph num="(b)"> <text>State the reason for the return.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>There is no registration fee for submitting a registration form.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A registrant is not required to reregister for subsequent elections.</text> </paragraph> <paragraph num="D."> <text>A registration form may be obtained:</text> <paragraph num="(1)"> <text>By contacting the Board; or</text> </paragraph> <paragraph num="(2)"> <text>From the Board's website.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A State dental organization affiliated with a national organization and a State dental hygienist organization affiliated with a national organization shall notify the Board in writing of any change of address or telephone number.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Resignation; Death."> <text>A special election may not be held for a dentist or a dental hygienist who:</text> <paragraph num="A."> <text>Resigns from the Board; or</text> </paragraph> <paragraph num="B."> <text>Dies while a Board member.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Qualifications."> <paragraph num="A."> <text>Dentist.</text> <paragraph num="(1)"> <text>Each dentist Board member shall:</text> <paragraph num="(a)"> <text>Be an individual of recognized ability and honor;</text> </paragraph> <paragraph num="(b)"> <text>Be a practicing holder of a general license to practice dentistry who has practiced dentistry actively in this State for at least 5 years immediately before appointment; and</text> </paragraph> <paragraph num="(c)"> <text>Be a resident of this State.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the case of a Board member belonging to an association whose members are regulated by the Board, the dentist may not be:</text> <paragraph num="(a)"> <text>An officer of the association;</text> </paragraph> <paragraph num="(b)"> <text>A member of the association's governing board or committee;</text> </paragraph> <paragraph num="(c)"> <text>A member of the association's house of delegates; or</text> </paragraph> <paragraph num="(d)"> <text>A voting member of a committee of the association that contributes to the establishment of governmental, regulatory, or legislative policy objectives of the association.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dental Hygienist.</text> <paragraph num="(1)"> <text>Each dental hygienist Board member shall:</text> <paragraph num="(a)"> <text>Be a practicing holder of a general license to practice dental hygiene who has practiced dental hygiene actively in this State for at least 3 years immediately before appointment; and</text> </paragraph> <paragraph num="(b)"> <text>Be a resident of this State.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In the case of a Board member belonging to an association whose members are regulated by the Board, the dental hygienist may not be:</text> <paragraph num="(a)"> <text>An officer of the association;</text> </paragraph> <paragraph num="(b)"> <text>A member of the association's governing board or committee;</text> </paragraph> <paragraph num="(c)"> <text>A member of the association's house of delegates; or</text> </paragraph> <paragraph num="(d)"> <text>A voting member of a committee of the association that contributes to the establishment of governmental, regulatory, or legislative policy objectives of the association.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall disqualify any candidate that does not meet the qualifications of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Election Judge."> <paragraph num="A."> <text>One of the following individuals shall be the Election Judge in the order indicated:</text> <paragraph num="(1)"> <text>The Board's President unless the President is:</text> <paragraph num="(a)"> <text>Absent; or</text> </paragraph> <paragraph num="(b)"> <text>Eligible for and seeks reappointment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board's President-Elect unless the President-Elect is:</text> <paragraph num="(a)"> <text>Absent; or</text> </paragraph> <paragraph num="(b)"> <text>Eligible for and seeks reappointment;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board's Secretary-Treasurer unless the Secretary-Treasurer is:</text> <paragraph num="(a)"> <text>Absent; or</text> </paragraph> <paragraph num="(b)"> <text>Eligible for and seeks reappointment;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The member of the Board who has received either a dental license or a dental hygiene license in this State before any other Board member;</text> </paragraph> <paragraph num="(5)"> <text>The member of the Board who has been appointed to the Board longer than any other Board member; or</text> </paragraph> <paragraph num="(6)"> <text>The oldest member of the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A consumer member of the Board is not eligible to be the presiding chair under §A(5) and (6) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Balloting."> <paragraph num="A."> <text>Balloting shall be by either:</text> <paragraph num="(1)"> <text>Electronic mail (e-mail); or</text> </paragraph> <paragraph num="(2)"> <text>Paper ballot.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist may cast a single vote for a qualified candidate.</text> </paragraph> <paragraph num="C."> <text>A dental hygienist may cast a single vote for a qualified candidate.</text> </paragraph> <paragraph num="D."> <text>A dentist or a dental hygienist who was not mailed a written solicitation for nominations and notice of the election, or who was not mailed an e-mail solicitation to vote but is otherwise qualified to vote at the time of the election shall be permitted to vote during the election.</text> </paragraph> <paragraph num="E."> <text>Voting Procedures.</text> <paragraph num="(1)"> <text>Voting shall be performed by e-mail ballot or paper ballot during a time specified by the Board.</text> </paragraph> <paragraph num="(2)"> <text>Eligible voters with e-mail addresses on file with the Board shall be provided with an e-mail ballot.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall make a paper ballot available to eligible voters upon request.</text> </paragraph> <paragraph num="(4)"> <text>Notwithstanding its postmark the paper ballot must be completed, signed, and received by the Board during a time specified by the Board.</text> </paragraph> <paragraph num="(5)"> <text>There shall be no absentee ballots.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An election may be held for one or more vacancies after the vacancy or vacancies have occurred.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Tallying of Ballots."> <paragraph num="A."> <text>Ballots shall be tallied by either:</text> <paragraph num="(1)"> <text>The Board; or</text> </paragraph> <paragraph num="(2)"> <text>A designee of the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Ballots may be tallied electronically, manually, or a combination thereof.</text> </paragraph> <paragraph num="C."> <text>In the event that the Board tallies the ballots for the dentist's election, the Executive Director shall tally the ballots in the presence of:</text> <paragraph num="(1)"> <text>The President of the Board;</text> </paragraph> <paragraph num="(2)"> <text>A dental hygienist member of the Board;</text> </paragraph> <paragraph num="(3)"> <text>A consumer member of the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Representatives from State dental organizations affiliated with a national organization that are properly registered with the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In the event that the Board tallies the ballots for the dental hygienist's election, the Executive Director shall tally the ballots in the presence of:</text> <paragraph num="(1)"> <text>The President of the Board;</text> </paragraph> <paragraph num="(2)"> <text>A dentist member of the Board;</text> </paragraph> <paragraph num="(3)"> <text>A consumer member of the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Representatives from State dental hygienist organizations affiliated with a national organization that are properly registered with the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Disqualified Ballots. The Board shall disqualify:</text> <paragraph num="(1)"> <text>The ballot of any dentist or dental hygienist who was not qualified to vote;</text> </paragraph> <paragraph num="(2)"> <text>The ballot for any dentist or dental hygienist who was not a qualified candidate;</text> </paragraph> <paragraph num="(3)"> <text>A ballot received after its due date;</text> </paragraph> <paragraph num="(4)"> <text>All ballots of a dentist or dental hygienist who attempts to vote more than once; or</text> </paragraph> <paragraph num="(5)"> <text>Any ballot that does not otherwise meet the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Board shall disqualify the nomination of any candidate who was not a qualified candidate.</text> </paragraph> <paragraph num="G."> <text>The Board shall retain possession of the results of the balloting and any paper ballots for at least 3 years.</text> </paragraph> <paragraph num="H."> <text>The Board shall post the results of the balloting on its website.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Aggrieved Dentist or Dental Hygienist."> <paragraph num="A."> <text>Grievance.</text> <paragraph num="(1)"> <text>A dentist nominee or a dental hygienist nominee aggrieved by the election process shall submit a grievance in writing by hand delivery to the offices of the Board within 5 days of the alleged occurrence.</text> </paragraph> <paragraph num="(2)"> <text>The grievance shall contain all relevant facts of alleged impropriety and have attached all relevant documents.</text> </paragraph> <paragraph num="(3)"> <text>The grievance shall be signed by the grievant, dated, and contain an affidavit from the grievant that states: “I solemnly affirm under penalties of perjury and upon personal knowledge that the contents of the foregoing paper and all attachments, if any, are true.”</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall provide the presiding officer and members of the Board with a copy of the grievance within 3 business days of its receipt.</text> </paragraph> <paragraph num="C."> <text>The election judge or the election judge's designee shall investigate the allegations.</text> </paragraph> <paragraph num="D."> <text>Decision.</text> <paragraph num="(1)"> <text>The election judge shall make a decision regarding the grievance.</text> </paragraph> <paragraph num="(2)"> <text>The decision of the election judge shall be:</text> <paragraph num="(a)"> <text>In writing;</text> </paragraph> <paragraph num="(b)"> <text>Mailed to the grievant by first class mail postage prepaid; and</text> </paragraph> <paragraph num="(c)"> <text>Delivered to the members of the Board for the Board's review.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Election Judge and Board's Review of Grievance."> <paragraph num="A."> <text>The election judge shall have the responsibility and authority to resolve any matters in dispute regarding the election process.</text> </paragraph> <paragraph num="B."> <text>Except for §C of this regulation, the determination of the election judge shall be final.</text> </paragraph> <paragraph num="C."> <text>The decision of the election judge may be reversed or modified by a 75 percent or more vote of a quorum of the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Names of Nominees Submitted to the Governor."> <paragraph num="A."> <text>The Board shall submit the result of the balloting to the Governor in a list of names in descending order indicating the number of votes received by each candidate.</text> </paragraph> <paragraph num="B."> <text>For dentists, the number of names on the list for each vacancy shall be as follows:</text> <paragraph num="(1)"> <text>One vacancy-at least four names;</text> </paragraph> <paragraph num="(2)"> <text>Two vacancies-at least three names for each vacancy; and</text> </paragraph> <paragraph num="(3)"> <text>Three or more vacancies-at least two names for each vacancy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>For dental hygienists, the number of names on the list shall be 4 times the number of vacancies.</text> </paragraph> <paragraph num="D."> <text>A tie vote shall be reported as a tie vote.</text> </paragraph> <paragraph num="E."> <text>The inability to provide the number of names requested in §B of this regulation does not invalidate:</text> <paragraph num="(1)"> <text>The election; or</text> </paragraph> <paragraph num="(2)"> <text>The Governor's appointments.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Disclosure to the Public."> <text>The names of the individuals who are nominees may not be disclosed to the public until the names are posted on the Board's website.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Violations."> <paragraph num="A."> <text>Substantial Violations.</text> <paragraph num="(1)"> <text>The election judge may determine that a substantial violation or violations of this chapter have occurred.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a substantial violation of this chapter, the election judge may, in the judge's discretion and subject to Regulation .12C of this chapter, declare the election invalid.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nonsubstantial Violations. A violation of this chapter that is determined by the election judge not to be substantial shall not invalidate the election process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Invalid Elections."> <paragraph num="A."> <text>Dentist.</text> <paragraph num="(1)"> <text>If an election for a dentist board member is declared invalid by the election judge, the Board shall notify by regular mail or by e-mail:</text> <paragraph num="(a)"> <text>Each dentist; and</text> </paragraph> <paragraph num="(b)"> <text>Each State dental organization affiliated with a national organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice referred to in §A(1) of this regulation shall state:</text> <paragraph num="(a)"> <text>The reason that the election has been declared invalid;</text> </paragraph> <paragraph num="(b)"> <text>The date, time, and location of the new election;</text> </paragraph> <paragraph num="(c)"> <text>Whether it is necessary to solicit nominations for the new election; and</text> </paragraph> <paragraph num="(d)"> <text>Any other information the Board finds necessary to ensure that the subsequent election is properly conducted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dental Hygienist.</text> <paragraph num="(1)"> <text>If an election for a dental hygienist board member is declared invalid by the election judge, the Board shall notify by regular mail or by e-mail:</text> <paragraph num="(a)"> <text>Each dental hygienist; and</text> </paragraph> <paragraph num="(b)"> <text>Each State dental hygienist organization affiliated with a national organization.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The notice referred to in §B(1) of this regulation shall state:</text> <paragraph num="(a)"> <text>The reason that the election has been declared invalid;</text> </paragraph> <paragraph num="(b)"> <text>The date, time, and location of the new election;</text> </paragraph> <paragraph num="(c)"> <text>Whether it is necessary to solicit nominations for the new election; and</text> </paragraph> <paragraph num="(d)"> <text>Any other information the Board finds necessary to ensure that the subsequent election is properly conducted.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-202, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .19 adopted as an emergency provision effective January 23, 2009 (36:4 Md. R. 345); emergency status extended to July 1, 2009 (36:10 Md. R. 715); emergency status expired</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .16 adopted as an emergency provision effective April 6, 2010 (37:10 Md. R. 718); adopted permanently effective June 28, 2010 (37:13 Md. R. 852)</annotation> </annotations> </chapter> <chapter num="30" heading="Record Keeping"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter covers the production and maintenance of patient records by dentists in any form or medium.</text> </paragraph> <paragraph num="B."> <text>The following is not governed by this chapter:</text> <paragraph num="(1)"> <text>Retention schedules of dental records;</text> </paragraph> <paragraph num="(2)"> <text>Confidentiality of dental records;</text> </paragraph> <paragraph num="(3)"> <text>Disclosure of dental records;</text> </paragraph> <paragraph num="(4)"> <text>Requests for copies of dental records;</text> </paragraph> <paragraph num="(5)"> <text>Concealment of dental records;</text> </paragraph> <paragraph num="(6)"> <text>Destruction and disposal of dental records; and</text> </paragraph> <paragraph num="(7)"> <text>Requirements imposed by:</text> <paragraph num="(a)"> <text>45 CFR Part 160, as amended; and</text> </paragraph> <paragraph num="(b)"> <text>45 CFR Part 164, as amended.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Definitions."> <paragraph num="A."> <text>In this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Best practices” means a method or technique that through experience and research has shown to reliably lead to results superior to those achieved by other means.</text> </paragraph> <paragraph num="(2)"> <text>“Electronic health records” means health records created and maintained on computer or other electronic device.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="General Provisions for Handwritten, Typed, and Electronic Health Records."> <paragraph num="A."> <text>A dentist shall create and maintain a separate dental record for each patient.</text> </paragraph> <paragraph num="B."> <text>Dental records shall include:</text> <paragraph num="(1)"> <text>A patient’s clinical chart as described in Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Financial records as described in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Dental records may be:</text> <paragraph num="(1)"> <text>Handwritten in ink;</text> </paragraph> <paragraph num="(2)"> <text>Typed; or</text> </paragraph> <paragraph num="(3)"> <text>Generated on a computer or other electronic device.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Dental records may not be created or maintained in pencil.</text> </paragraph> <paragraph num="E."> <text>If treatment is rendered, dental records shall be made contemporaneously with the treatment rendered.</text> </paragraph> <paragraph num="F."> <text>Dental records shall be created and maintained for each individual seeking or receiving dental services, regardless of whether:</text> <paragraph num="(1)"> <text>Any treatment is actually rendered; or</text> </paragraph> <paragraph num="(2)"> <text>Any fee is charged.</text> </paragraph> </paragraph> <paragraph num="G."> <text>All entries shall be dated.</text> </paragraph> <paragraph num="H."> <text>Electronic Health Records.</text> <paragraph num="(1)"> <text>A dentist who creates and maintains electronic health records shall utilize best practices related to:</text> <paragraph num="(a)"> <text>Hazard and risk analysis and mitigation;</text> </paragraph> <paragraph num="(b)"> <text>Software development;</text> </paragraph> <paragraph num="(c)"> <text>Validation;</text> </paragraph> <paragraph num="(d)"> <text>Maintenance;</text> </paragraph> <paragraph num="(e)"> <text>Security measures; and</text> </paragraph> <paragraph num="(f)"> <text>System integration and operation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dentist who creates and maintains electronic health records shall maintain a back-up copy of the records and, if feasible, a back-up copy off site.</text> </paragraph> <paragraph num="(3)"> <text>The initials and signatures in electronic health records required by this chapter may be produced electronically.</text> </paragraph> <paragraph num="(4)"> <text>Electronic health record systems shall include an audit-trail function that details all interactions between systems and their users and all interactions among systems.</text> </paragraph> <paragraph num="(5)"> <text>The audit-trail identified in §H(4) of this regulation shall include:</text> <paragraph num="(a)"> <text>Attempted or successful unauthorized access to the electronic health records where the determination is feasible;</text> </paragraph> <paragraph num="(b)"> <text>Attempted or successful unauthorized modification or destruction of any records where the determination is feasible;</text> </paragraph> <paragraph num="(c)"> <text>Interference with application operations of the electronic records;</text> </paragraph> <paragraph num="(d)"> <text>Any setting of or change to logical access controls related to the dispensing of controlled substance prescriptions; and</text> </paragraph> <paragraph num="(e)"> <text>Attempted or successful interference with audit trail functions.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Electronic health record systems shall provide the capability to produce a hard copy business version of each treatment or progress note and shall indicate:</text> <paragraph num="(a)"> <text>The date and time of each entry;</text> </paragraph> <paragraph num="(b)"> <text>The identity of each individual who made the entry;</text> </paragraph> <paragraph num="(c)"> <text>The method used in the creation of each entry, which shall include but not be limited to:</text> <paragraph num="(i)"> <text>Direct entry via keyboard or mouse;</text> </paragraph> <paragraph num="(ii)"> <text>Speech recognition;</text> </paragraph> <paragraph num="(iii)"> <text>Automation;</text> </paragraph> <paragraph num="(iv)"> <text>Machine-entered default information;</text> </paragraph> <paragraph num="(v)"> <text>Pre-created documentation via form or template;</text> </paragraph> <paragraph num="(vi)"> <text>Copy or import of an object including the date and time of the entry and the identity of the original author;</text> </paragraph> <paragraph num="(vii)"> <text>Copy forward previous note contents including the date and time of the entry and the identity of the original author; and</text> </paragraph> <paragraph num="(viii)"> <text>Dictation and transcription from an external system.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A dental record shall contain:</text> <paragraph num="(1)"> <text>The patient’s name or other patient identifier;</text> </paragraph> <paragraph num="(2)"> <text>If the patient is a minor, the name and address of the patient’s parents or guardian;</text> </paragraph> <paragraph num="(3)"> <text>The patient’s address and telephone number;</text> </paragraph> <paragraph num="(4)"> <text>The patient’s date of birth;</text> </paragraph> <paragraph num="(5)"> <text>The patient’s place of employment if the patient wishes to provide the information;</text> </paragraph> <paragraph num="(6)"> <text>Emergency contact information;</text> </paragraph> <paragraph num="(7)"> <text>Medical and dental histories which shall be updated at each visit; and</text> </paragraph> <paragraph num="(8)"> <text>Insurance information.</text> </paragraph> </paragraph> <paragraph num="J."> <text>To the extent practicable, each document in the dental records shall contain one or more patient identifiers.</text> </paragraph> <paragraph num="K."> <text>Dental records shall:</text> <paragraph num="(1)"> <text>Be accurate;</text> </paragraph> <paragraph num="(2)"> <text>Be detailed;</text> </paragraph> <paragraph num="(3)"> <text>Be legible;</text> </paragraph> <paragraph num="(4)"> <text>Be well organized; and</text> </paragraph> <paragraph num="(5)"> <text>Document all data in the dentist’s possession pertaining to the patient's dental health status;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Entries shall be signed or initialed by the individual who provided the treatment.</text> </paragraph> <paragraph num="M."> <text>With the exception of dental hygienists, entries made by auxiliary personnel shall be:</text> <paragraph num="(1)"> <text>Reviewed by the treating dentist; and</text> </paragraph> <paragraph num="(2)"> <text>Signed or initialed by the treating dentist.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Entries made by individuals other than the individual who provided the treatment shall:</text> <paragraph num="(1)"> <text>Identify the individual who made the entry;</text> </paragraph> <paragraph num="(2)"> <text>Identify the individual who provided the treatment;</text> </paragraph> <paragraph num="(3)"> <text>Be signed or initialed by the individual who provided the treatment; and</text> </paragraph> <paragraph num="(4)"> <text>Be signed or initialed by the treating dentist.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Exception. Entries made by an individual other than the individual who provided the treatment may not require the signature or initials of the treating dentist if the treatment was provided by a dental hygienist.</text> </paragraph> <paragraph num="P."> <text>A dentist and auxiliary personnel may not erase, alter, obliterate, or “white out” dental records.</text> </paragraph> <paragraph num="Q."> <text>Blank spaces may not be left between entries.</text> </paragraph> <paragraph num="R."> <text>Changes to handwritten and typed dental records shall:</text> <paragraph num="(1)"> <text>Be made by a single line strike-through of the incorrect entry so that the incorrect entry may be read;</text> </paragraph> <paragraph num="(2)"> <text>Contain changes in the corresponding margin or in close proximity to the incorrect entry;</text> </paragraph> <paragraph num="(3)"> <text>Be dated;</text> </paragraph> <paragraph num="(4)"> <text>Be signed or initialed by the treating dentist; and</text> </paragraph> <paragraph num="(5)"> <text>If the change was made by auxiliary personnel:</text> <paragraph num="(a)"> <text>Be reviewed;</text> </paragraph> <paragraph num="(b)"> <text>Be approved; and</text> </paragraph> <paragraph num="(c)"> <text>Be signed or initialed by the treating dentist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="S."> <text>The dental records shall contain only those abbreviations that are commonly acceptable within the profession and comprehensible to other dentists.</text> </paragraph> <paragraph num="T."> <text>Except for notations of payment or failure to make payment, financial records may not be maintained in the clinical chart.</text> </paragraph> <paragraph num="U."> <text>Dentists are responsible for the content of the dental records.</text> </paragraph> <paragraph num="V."> <text>A dentist who has been issued a dispensing permit by the Board shall maintain dispensing records in accordance with Regulation .03J of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Clinical Charts."> <paragraph num="A."> <text>Each patient’s clinical chart shall include at a minimum the following:</text> <paragraph num="(1)"> <text>Patient's name and date of treatment;</text> </paragraph> <paragraph num="(2)"> <text>Reasons for the patient’s visit;</text> </paragraph> <paragraph num="(3)"> <text>Treatment plans that are signed and dated by both the treating dentist and the patient;</text> </paragraph> <paragraph num="(4)"> <text>Patient’s complaints;</text> </paragraph> <paragraph num="(5)"> <text>Diagnosis and treatment notes;</text> </paragraph> <paragraph num="(6)"> <text>Progress notes;</text> </paragraph> <paragraph num="(7)"> <text>Post operative instructions;</text> </paragraph> <paragraph num="(8)"> <text>Study models;</text> </paragraph> <paragraph num="(9)"> <text>In-person conversations, telephone conversations, and other correspondence with the patient or their representative;</text> </paragraph> <paragraph num="(10)"> <text>Identification of medications prescribed, administered, dispensed, quantity, and directions for use;</text> </paragraph> <paragraph num="(11)"> <text>Clinical details with regard to the administration of:</text> <paragraph num="(a)"> <text>Nitrous oxide;</text> </paragraph> <paragraph num="(b)"> <text>Anxiolytics;</text> </paragraph> <paragraph num="(c)"> <text>Sedation; and</text> </paragraph> <paragraph num="(d)"> <text>General anesthesia.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Radiographs of diagnostic quality;</text> </paragraph> <paragraph num="(13)"> <text>Periodontal charting;</text> </paragraph> <paragraph num="(14)"> <text>Laboratory work authorization forms and correspondence to and from laboratories;</text> </paragraph> <paragraph num="(15)"> <text>Informed consent;</text> </paragraph> <paragraph num="(16)"> <text>Copies of correspondence and reports provided to other health care providers, diagnostic facilities, and legal representatives;</text> </paragraph> <paragraph num="(17)"> <text>Records and reports provided by other health care providers and diagnostic facilities;</text> </paragraph> <paragraph num="(18)"> <text>Details regarding referrals and consultations;</text> </paragraph> <paragraph num="(19)"> <text>Patient complaints pertaining to the dentist and staff, and their manner of resolution;</text> </paragraph> <paragraph num="(20)"> <text>Noncompliance and missed appointment notes; and</text> </paragraph> <paragraph num="(21)"> <text>Dismissal letter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dentist who performs diabetes or blood pressure screening shall include the results of the screenings in the patient’s clinical chart.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Financial Records."> <paragraph num="A."> <text>Financial records shall be considered part of the dental records but shall be maintained separately from the patient’s clinical chart.</text> </paragraph> <paragraph num="B."> <text>Financial records shall include at a minimum the following:</text> <paragraph num="(1)"> <text>Complete financial data concerning the patient’s account, including:</text> <paragraph num="(a)"> <text>Each amount billed to or received from the patient or third-party payor; and</text> </paragraph> <paragraph num="(b)"> <text>The date of each bill and each payment;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Copies of all claim forms submitted to third-party payors by the dentist or by the dentist’s agent or employee; and</text> </paragraph> <paragraph num="(3)"> <text>Payment vouchers received from third-party payors.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Violations."> <text>Failure to comply with this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-205(c)(3), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 11, 2012 (39:11 Md. R. 687)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective April 29, 2013 (40:8 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 29, 2013 (40:8 Md. R. 724)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 29, 2013 (40:8 Md. R. 724)</annotation> </annotations> </chapter> <chapter num="31" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter shall be used by the Board and the Maryland Office of Administrative Hearings as a framework for imposing discipline.</text> </paragraph> <paragraph num="B."> <text>The Board and the Maryland Office of Administrative Hearings shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation.</text> </paragraph> <paragraph num="C."> <text>The Board shall complete a worksheet for each complaint considered by the Board that is not initially closed.</text> </paragraph> <paragraph num="D."> <text>The Board is aware that there may be conduct by a licensee or certificate holder that does not fall squarely within a particular grid contained in Regulation .06 of this chapter. In that event the Board will so indicate on the worksheet and use its best judgment to determine the appropriate sanction.</text> </paragraph> <paragraph num="E."> <text>The Board and the Maryland Office of Administrative Hearings shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees and certificate holders.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Conditions” means requirements in a public or nonpublic order that a licensee or certificate holder must satisfy which include but are not limited to:</text> <paragraph num="(a)"> <text>Treatment and counseling for an emotional or physical illness;</text> </paragraph> <paragraph num="(b)"> <text>Submission to drug and alcohol testing;</text> </paragraph> <paragraph num="(c)"> <text>Abstinence from specified drugs;</text> </paragraph> <paragraph num="(d)"> <text>Abstinence from alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Remedial training;</text> </paragraph> <paragraph num="(f)"> <text>Inspection;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring;</text> </paragraph> <paragraph num="(h)"> <text>Evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(j)"> <text>Testing of clinical skills;</text> </paragraph> <paragraph num="(k)"> <text>Submission of written reports;</text> </paragraph> <paragraph num="(l)"> <text>A demonstration of knowledge or competency;</text> </paragraph> <paragraph num="(m)"> <text>Limitation of practice;</text> </paragraph> <paragraph num="(n)"> <text>Limitation on the administration or prescription of specified drugs to patients;</text> </paragraph> <paragraph num="(o)"> <text>The provision of pro bono dental care to the poor, elderly, or disabled;</text> </paragraph> <paragraph num="(p)"> <text>Obeyance of dental laws, including federal, State, and local laws;</text> </paragraph> <paragraph num="(q)"> <text>An anonymous monetary donation; and</text> </paragraph> <paragraph num="(r)"> <text>The payment of a civil penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Conduct” means behavior or action, or a failure to behave or act, that results in a violation of the Maryland Dentistry Act or the regulations adopted by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees and certificate holders in formal and informal actions and proceedings.</text> </paragraph> <paragraph num="B."> <text>Except as provided in Regulation .05 of this chapter, the Board shall impose a sanction not less severe than the minimum listed in Regulation .06 of this chapter, nor more severe than the maximum listed in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>When conduct results in multiple violations of the Maryland Dentistry Act and the regulations adopted by the Board, the Board shall consider sanctions that are greater than those imposed for a single violation.</text> </paragraph> <paragraph num="D."> <text>This chapter does not apply to disciplinary matters reviewed by the Board that are initially closed.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise indicated, the period of a suspension may be stayed in whole or in part.</text> </paragraph> <paragraph num="F."> <text>A respondent placed on suspension or probation shall have conditions attached to the suspension or probation which focus on the conduct and steps needed to assure public protection.</text> </paragraph> <paragraph num="G."> <text>Consent orders shall:</text> <paragraph num="(1)"> <text>Include an acknowledgement of the violation or violations; and</text> </paragraph> <paragraph num="(2)"> <text>Indicate that the respondent accepts personal responsibility for the respondent's behavior.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the conduct is not described in Regulation .06 of this chapter, the Board shall use its judgment to determine appropriate sanctions and shall so state in the sanctions worksheet.</text> </paragraph> <paragraph num="I."> <text>A departure from the sanctioning guidelines alone may not be grounds for any hearing or appeal of any Board action before the Board or the Maryland Office of Administrative Hearings.</text> </paragraph> <paragraph num="J."> <text>The sanctioning guidelines are not applicable to:</text> <paragraph num="(1)"> <text>Individuals seeking an initial license or certificate; or</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a license or certificate under State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Notwithstanding the sanctioning guidelines, a respondent may surrender a license or certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Worksheet."> <paragraph num="A."> <text>The Board shall complete a sanctions worksheet after considering each disciplinary matter.</text> </paragraph> <paragraph num="B."> <text>The sanctions worksheet shall, at a minimum:</text> <paragraph num="(1)"> <text>Briefly summarize the conduct that constituted the violation or violations meriting action;</text> </paragraph> <paragraph num="(2)"> <text>Identify the severity of the conduct;</text> </paragraph> <paragraph num="(3)"> <text>Describe other factors that the Board considered in determining the recommended sanctions imposed, including but not limited to:</text> <paragraph num="(a)"> <text>Aggravating factors as outlined in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Mitigating factors as outlined in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Prior disciplinary history; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Identify the recommended sanctions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board’s summary of the conduct that constituted the violation or violations need not:</text> <paragraph num="(1)"> <text>Be exhaustive; or</text> </paragraph> <paragraph num="(2)"> <text>Include every violation meriting action by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The existence of one or more aggravating or mitigating factors contained in Regulation .05 of this chapter does not impose on the Board any requirement to make findings of fact or to articulate its reasoning for not exercising its discretion to impose a sanction outside the range of sanctions.</text> </paragraph> <paragraph num="E."> <text>A copy of the sanctions worksheet may be obtained by the respondent or the respondent's legal representative.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Aggravating and Mitigating Factors."> <paragraph num="A."> <text>Sanctions in a particular case may fall outside the range of the sanctioning guidelines established by the Board.</text> </paragraph> <paragraph num="B."> <text>If the sanctions imposed by the Board fall outside the range of the sanctioning guidelines, the Board shall state its reasons on its worksheet.</text> </paragraph> <paragraph num="C."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of the sanctioning guidelines:</text> <paragraph num="(1)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative discipline history;</text> </paragraph> <paragraph num="(b)"> <text>Whether the offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>Whether the offense has the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>Whether the offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>Whether the respondent pursued the respondent's financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was especially vulnerable;</text> </paragraph> <paragraph num="(g)"> <text>Whether the respondent attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(h)"> <text>Whether the respondent:</text> <paragraph num="(i)"> <text>Concealed, falsified, or destroyed evidence; or</text> </paragraph> <paragraph num="(ii)"> <text>Presented false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Whether the respondent willfully and without legal justification failed to cooperate with a lawful investigation conducted by the Board; and</text> </paragraph> <paragraph num="(j)"> <text>Whether previous attempts to rehabilitate the respondent were unsuccessful; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The passage of time since any prior offenses;</text> </paragraph> <paragraph num="(c)"> <text>Whether the respondent self-reported to the Board;</text> </paragraph> <paragraph num="(d)"> <text>Cooperation with the Board’s investigation;</text> </paragraph> <paragraph num="(e)"> <text>Full disclosure to the Board;</text> </paragraph> <paragraph num="(f)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(g)"> <text>Timely good-faith efforts to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(i)"> <text>Absence of premeditation to commit the offense;</text> </paragraph> <paragraph num="(j)"> <text>Absence of potential harm to the public;</text> </paragraph> <paragraph num="(k)"> <text>Absence of adverse impact;</text> </paragraph> <paragraph num="(l)"> <text>Whether the offense was an isolated incident and not likely to recur;</text> </paragraph> <paragraph num="(m)"> <text>How and when the respondent has been involved in community service and the value of the community service to the community; and</text> </paragraph> <paragraph num="(n)"> <text>Voluntary admissions of misconduct.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disciplinary Guidelines."> <text>The following guidelines shall be used by the Board when sanctioning licensees and certificate holders in formal and informal actions and proceedings:</text> <paragraph num="A."> <text>Abuse — Physical and Emotional.</text> </paragraph> <paragraph num="B."> <text>Advertising.</text> </paragraph> <paragraph num="C."> <text>Criminal Convictions or Plea of Nolo Contendere.</text> </paragraph> <paragraph num="D."> <text>Disciplined by Another Licensing or Disciplinary Authority.</text> </paragraph> <paragraph num="E."> <text>Diversion of Controlled Substances or Prescription Drugs.</text> </paragraph> <paragraph num="F."> <text>Infection Control Guidelines — Centers for Disease Control and Prevention (CDC).</text> </paragraph> <paragraph num="G."> <text>Late License and Certificate Renewal When the Licensee or Certificate Holder Has Continued to Practice.</text> </paragraph> <paragraph num="H."> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="I."> <text>Practice Below Acceptable Standards of Care.</text> </paragraph> <paragraph num="J."> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="K."> <text>Substance Abuse.</text> </paragraph> <paragraph num="L."> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="M."> <text>Unprofessional Conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §1-606, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 23, 2012 (39:1 Md. R. 18)</annotation> </annotations> </chapter> <chapter num="32" heading="General Competency Requirements"> <regulation prefix="Regulation" num=".01" heading="Definition."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Practice dentistry” means to:</text> <paragraph num="(1)"> <text>Be a manager, a proprietor, or a conductor of or an operator in any place in which a dental service or dental operation is performed intraorally;</text> </paragraph> <paragraph num="(2)"> <text>Perform or attempt to perform any intraoral dental service or intraoral dental operation;</text> </paragraph> <paragraph num="(3)"> <text>Diagnose, treat, or attempt to diagnose or treat any disease, injury, malocclusion, or malposition of a tooth, gum, or jaw, or structures associated with a tooth, gum, or jaw if the service, operation, or procedure is included in:</text> <paragraph num="(a)"> <text>The curricula of an accredited dental school; or</text> </paragraph> <paragraph num="(b)"> <text>An approved dental residency program of an accredited hospital or teaching institution;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Perform or offer to perform dental laboratory work;</text> </paragraph> <paragraph num="(5)"> <text>Place or adjust a dental appliance in a human mouth; or</text> </paragraph> <paragraph num="(6)"> <text>Administer anesthesia for the purposes of dentistry and not as a medical specialty.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Professional Competence."> <paragraph num="A."> <text>A dentist shall practice dentistry as defined in Regulation .01 of this chapter.</text> </paragraph> <paragraph num="B."> <text>A dentist shall:</text> <paragraph num="(1)"> <text>Limit their practice to the areas of competence by which proficiency has been gained through education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Acquire the special education and training needed to address the cultural differences of diverse populations;</text> </paragraph> <paragraph num="(3)"> <text>Avoid unfair discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, or other basis proscribed by law;</text> </paragraph> <paragraph num="(4)"> <text>Use treatment only when the dentist knows that the circumstances are appropriate;</text> </paragraph> <paragraph num="(5)"> <text>Maintain competence by meeting the requirements of continuing education in accordance with COMAR 10.44.22;</text> </paragraph> <paragraph num="(6)"> <text>Engage in ongoing consultation with other dentists or relevant professionals;</text> </paragraph> <paragraph num="(7)"> <text>Seek appropriate education, training, and experience when developing competence in a new service or technique; and</text> </paragraph> <paragraph num="(8)"> <text>Document and maintain appropriate records of all relevant course work and training used to gain competence.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§4-205(a)(5), 4-205(c)(3), and 4-315(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 9, 2012 (39:13 Md. R. 786)</annotation> </annotations> </chapter> <chapter num="33" heading="Temporary Licenses for Volunteer Dentists and Dental Hygienists and Temporary Dental Clinic Permits"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the requirements for the issuance of:</text> <paragraph num="A."> <text>A temporary volunteer dentist’s license to practice dentistry;</text> </paragraph> <paragraph num="B."> <text>A temporary volunteer dental hygienist’s license to practice dental hygiene; and</text> </paragraph> <paragraph num="C."> <text>A temporary dental clinic permit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Temporary dental clinic” means a dental clinic of a specific limited duration at which a bona fide charitable organization provides dental services to the poor, elderly, or disabled.</text> </paragraph> <paragraph num="(3)"> <text>“Temporary dental clinic permit” means a temporary permit issued by the Board to a bona fide charitable organization to provide dental services to the poor, elderly, or disabled at a temporary dental clinic.</text> </paragraph> <paragraph num="(4)"> <text>“Temporary volunteer dental hygienist’s license” means a temporary license issued by the Board to a dental hygienist who:</text> <paragraph num="(a)"> <text>Holds an active general license to practice clinical dental hygiene in another state; and</text> </paragraph> <paragraph num="(b)"> <text>Otherwise meets the requirements of this chapter to obtain a temporary volunteer dental hygienist’s license.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Temporary volunteer dentist’s license” means a temporary license issued by the Board to a dentist who:</text> <paragraph num="(a)"> <text>Holds an active general license to practice clinical dentistry in another state; and</text> </paragraph> <paragraph num="(b)"> <text>Otherwise meets the requirements of this chapter to obtain a temporary volunteer dentist’s license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Temporary Volunteer Dentist’s License."> <paragraph num="A."> <text>License Required. A dentist who holds a general license to practice dentistry in another state may practice dentistry at a temporary dental clinic or for a government entity only after receiving a temporary volunteer dentist’s license to practice dentistry as provided in this chapter.</text> </paragraph> <paragraph num="B."> <text>Qualifications for Out-of-State Dentists.</text> <paragraph num="(1)"> <text>The Board shall issue a temporary volunteer dentist’s license to a dentist who satisfies the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>To qualify for a temporary volunteer dentist’s license, an applicant shall:</text> <paragraph num="(a)"> <text>Comply with the following:</text> <paragraph num="(i)"> <text>Submit a completed Board-approved application with the Board at least 60 days before the date the temporary dental clinic is scheduled to open;</text> </paragraph> <paragraph num="(ii)"> <text>Hold an active general license to practice clinical dentistry in another state that is not subject to clinical restrictions; and</text> </paragraph> <paragraph num="(iii)"> <text>Have passed the North East Regional Board Clinical Examination or submit to the Board a notarized affidavit or other evidence satisfactory to the Board that for the 5 years preceding application the applicant has actively engaged in the practice of dentistry for at least 850 hours on average per year;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide a notarized affidavit to the Board:</text> <paragraph num="(i)"> <text>Agreeing to donate dental services without compensation for a temporary dental clinic operated by a bona fide charitable organization or government entity; and</text> </paragraph> <paragraph num="(ii)"> <text>Indicating that the applicant does not practice dentistry for profit in the State;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide documentation to the Board that evidences that the dentist is covered by malpractice insurance; and</text> </paragraph> <paragraph num="(d)"> <text>Provide current verification of cardiopulmonary resuscitation certification.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may require a dentist seeking a temporary volunteer dentist’s license to:</text> <paragraph num="(a)"> <text>Pass the Maryland Jurisprudence Examination; or</text> </paragraph> <paragraph num="(b)"> <text>Fulfill any other requirements relating to knowledge of the laws and regulations concerning the practice of dentistry in the State.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant for a temporary volunteer dentist’s license may not be required to pay an application fee.</text> </paragraph> <paragraph num="(5)"> <text>The Board may deny a temporary volunteer dentist’s license on the grounds provided under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Practice Locations. A temporary volunteer dentist’s license authorizes the licensee to practice dentistry only in a temporary dental clinic providing medical care to the poor, elderly, or disabled that is operated by:</text> <paragraph num="(1)"> <text>A bona fide charitable organization;</text> </paragraph> <paragraph num="(2)"> <text>The State or a local government; or</text> </paragraph> <paragraph num="(3)"> <text>A local health department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Practice Restrictions.</text> <paragraph num="(1)"> <text>A dentist who holds a temporary volunteer dentist’s license may not administer, monitor, or maintain general anesthesia or sedation.</text> </paragraph> <paragraph num="(2)"> <text>A dentist who holds a temporary volunteer dentist’s license may administer, monitor, and maintain nitrous oxide oxygen.</text> </paragraph> <paragraph num="(3)"> <text>A dentist who holds a temporary volunteer dentist’s license may only provide services authorized under the:</text> <paragraph num="(a)"> <text>Maryland Dentistry Act; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations adopted by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Dentists Licensed in Maryland. A dentist who holds an active general license to practice dentistry in Maryland may:</text> <paragraph num="(1)"> <text>Practice at a temporary dental clinic without obtaining a temporary volunteer dentist’s license; and</text> </paragraph> <paragraph num="(2)"> <text>Only provide services authorized under the:</text> <paragraph num="(a)"> <text>Maryland Dentistry Act; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations adopted by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Follow-Up Care. The treating dentist shall ensure that each patient receives a form at the conclusion of treatment that contains:</text> <paragraph num="(1)"> <text>A summary of the services that were provided to the patient by the dentist and, if applicable, the dental hygienist; and</text> </paragraph> <paragraph num="(2)"> <text>Instructions for any recommended follow-up care.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Expiration and Renewal.</text> <paragraph num="(1)"> <text>A temporary volunteer dentist's license issued under this chapter shall be issued for the duration of the temporary dental clinic only and may not be renewed.</text> </paragraph> <paragraph num="(2)"> <text>The Board may issue a temporary volunteer dentist's license to a dentist who previously held a temporary volunteer dentist's license if the dentist:</text> <paragraph num="(a)"> <text>Applies for a new license; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfies the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Continuing Education. The Board may not require continuing education as a condition for the issuance of a temporary volunteer dentist’s license.</text> </paragraph> <paragraph num="I."> <text>Display of License. The holder of a temporary volunteer dentist’s license shall maintain the holder’s wallet license on the premises of the temporary dental clinic while practicing dentistry at the temporary dental clinic.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Temporary Volunteer Dental Hygienist's License."> <paragraph num="A."> <text>License Required. A dental hygienist who holds a general license to practice dental hygiene in another state may practice dental hygiene at a temporary dental clinic or for a government entity only after receiving a temporary volunteer dental hygienist’s license to practice dental hygiene as provided in this chapter.</text> </paragraph> <paragraph num="B."> <text>Qualifications for Out-of-State Dental Hygienists.</text> <paragraph num="(1)"> <text>The Board shall issue a temporary volunteer dental hygienist’s license to a dental hygienist who satisfies the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>To qualify for a temporary volunteer dental hygienist’s license, an applicant shall:</text> <paragraph num="(a)"> <text>Comply with the following:</text> <paragraph num="(i)"> <text>Submit a completed Board-approved application with the Board at least 60 days before the date the temporary dental clinic is scheduled to open;</text> </paragraph> <paragraph num="(ii)"> <text>Hold an active general license to practice clinical dental hygiene in another state that is not subject to clinical restrictions; and</text> </paragraph> <paragraph num="(iii)"> <text>Have passed the North East Regional Board Clinical Examination or submit to the Board a notarized affidavit or other evidence satisfactory to the Board that for the 3 years preceding application the applicant has actively engaged in the practice of dental hygiene for at least 150 hours on average per year;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Provide a notarized affidavit to the Board:</text> <paragraph num="(i)"> <text>Agreeing to donate dental hygiene services without compensation for a temporary dental clinic operated by a bona fide charitable organization or government entity; and</text> </paragraph> <paragraph num="(ii)"> <text>Indicating that the applicant does not practice dental hygiene for profit in the State;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide documentation to the Board that evidences that the dental hygienist is covered by malpractice insurance; and</text> </paragraph> <paragraph num="(d)"> <text>Provide current verification of cardiopulmonary resuscitation certification.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may require a dental hygienist seeking a temporary volunteer dental hygienist’s license to:</text> <paragraph num="(a)"> <text>Pass the Maryland Jurisprudence Examination; or</text> </paragraph> <paragraph num="(b)"> <text>Fulfill any other requirements relating to knowledge of the laws and regulations concerning the practice of dental hygiene in the State.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant for a temporary volunteer dental hygienist’s license may not be required to pay an application fee.</text> </paragraph> <paragraph num="(5)"> <text>The Board may deny a temporary volunteer dental hygienist’s license on the grounds provided under Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Practice Locations. A temporary volunteer dental hygienist's license authorizes the licensee to practice dental hygiene only in a temporary dental clinic providing medical care to the poor, elderly, or disabled that is operated by:</text> <paragraph num="(1)"> <text>A bona fide charitable organization;</text> </paragraph> <paragraph num="(2)"> <text>The State or a local government; or</text> </paragraph> <paragraph num="(3)"> <text>A local health department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Practice Restrictions.</text> <paragraph num="(1)"> <text>A dental hygienist who holds a temporary volunteer dental hygienist’s license may not:</text> <paragraph num="(a)"> <text>Administer, monitor, or maintain general anesthesia or sedation;</text> </paragraph> <paragraph num="(b)"> <text>Administer local anesthesia by infiltration;</text> </paragraph> <paragraph num="(c)"> <text>Administer block anesthesia; or</text> </paragraph> <paragraph num="(d)"> <text>Administer, monitor, or maintain nitrous oxide oxygen.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dental hygienist who holds a temporary volunteer dental hygienist’s license may only provide services authorized under the:</text> <paragraph num="(a)"> <text>Maryland Dentistry Act; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations adopted by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Dental Hygienists Licensed in Maryland. A dental hygienist who holds an active general license to practice dental hygiene in Maryland may:</text> <paragraph num="(1)"> <text>Practice at a temporary dental clinic without obtaining a temporary volunteer dental hygienist's license; and</text> </paragraph> <paragraph num="(2)"> <text>Only provide services authorized under the:</text> <paragraph num="(a)"> <text>Maryland Dentistry Act; and</text> </paragraph> <paragraph num="(b)"> <text>Regulations adopted by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>General Supervision.</text> <paragraph num="(1)"> <text>A temporary volunteer dental hygienist’s license authorizes the dental hygienist to practice dental hygiene at a temporary dental clinic under the general supervision of a dentist who:</text> <paragraph num="(a)"> <text>Is on the premises;</text> </paragraph> <paragraph num="(b)"> <text>Examines the patient at any time during the treatment; and</text> </paragraph> <paragraph num="(c)"> <text>Is available for personal consultation while the services are being performed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dental hygienist may:</text> <paragraph num="(a)"> <text>Perform an assessment of dental needs; and</text> </paragraph> <paragraph num="(b)"> <text>Provide dental hygiene services before an examination by a supervising dentist.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>This section may not be construed to:</text> <paragraph num="(a)"> <text>Require a preliminary dental examination or treatment by a dental hygienist; or</text> </paragraph> <paragraph num="(b)"> <text>Prohibit a supervising dentist from either examining a patient or providing treatment to a patient before treatment by a dental hygienist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Expiration and Renewal.</text> <paragraph num="(1)"> <text>A temporary volunteer dental hygienist's license issued under this chapter shall be issued for the duration of the temporary dental clinic only and may not be renewed.</text> </paragraph> <paragraph num="(2)"> <text>The Board may issue a temporary volunteer dental hygienist license to a dental hygienist who previously held a temporary volunteer dental hygienist license if the dental hygienist:</text> <paragraph num="(a)"> <text>Applies for a new license; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfies the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Continuing Education. The Board may not require continuing education as a condition for the issuance of a temporary volunteer dental hygienist’s license.</text> </paragraph> <paragraph num="I."> <text>Display of License. The holder of a temporary volunteer dental hygienist's license shall maintain the holder’s wallet license on the premises of the temporary dental clinic while practicing dental hygiene at the temporary dental clinic.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Temporary Dental Clinic Permit."> <paragraph num="A."> <text>Bona Fide Charitable Organization.</text> <paragraph num="(1)"> <text>A bona fide charitable organization may utilize holders of a temporary volunteer dentist’s license or a temporary volunteer dental hygienist’s license to provide dental services to the poor, elderly, or disabled at a temporary dental clinic only after receiving a temporary dental clinic permit issued by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall issue a temporary dental clinic permit to a bona fide charitable organization that meets the requirements of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>To apply for a temporary dental clinic permit, a bona fide charitable organization:</text> <paragraph num="(a)"> <text>Shall submit an application on a form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>May not be required to pay an application fee.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Expiration and Renewal of Permit.</text> <paragraph num="(a)"> <text>A temporary dental clinic permit issued under this chapter:</text> <paragraph num="(i)"> <text>Shall be issued for the duration of the temporary dental clinic only; and</text> </paragraph> <paragraph num="(ii)"> <text>May not be renewed.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Board may issue a temporary dental clinic permit to a bona fide charitable organization that previously held a temporary dental clinic permit if the bona fide charitable organization:</text> <paragraph num="(i)"> <text>Applies for a new permit; and</text> </paragraph> <paragraph num="(ii)"> <text>Satisfies the requirements of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>A bona fide charitable organization that conducts a temporary dental clinic under this chapter may not be construed to be practicing dentistry.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Government Entities.</text> <paragraph num="(1)"> <text>The State, a local government, or a local health department that provides dental services to the poor, elderly, or disabled and that wishes to utilize the services of dentists or dental hygienists that hold an active general license in another state at a temporary dental clinic shall at least 60 days before the services are to be provided:</text> <paragraph num="(a)"> <text>Provide written notice to the Board of:</text> <paragraph num="(i)"> <text>Its intention to provide the services;</text> </paragraph> <paragraph num="(ii)"> <text>The dates and location of the temporary dental clinic;</text> </paragraph> <paragraph num="(iii)"> <text>The name, address, and telephone number of the temporary dental clinic’s coordinator; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Indicate whether it has provided malpractice insurance to those who are applying for either a:</text> <paragraph num="(i)"> <text>Temporary volunteer dentist’s license; or</text> </paragraph> <paragraph num="(ii)"> <text>Temporary volunteer dental hygienist’s license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The State, a local government, or a local health department may not be required by the Board to seek authorization to provide services at a temporary dental clinic.</text> </paragraph> <paragraph num="(3)"> <text>A holder of an active general license to practice dentistry or dental hygiene in another state who wishes to provide dental services sponsored by the State, a local government, or a local health department shall obtain a temporary volunteer dentist’s license or a temporary volunteer dental hygienist’s license as provided in this chapter before providing the dental services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Permit Holders. The holder of a temporary dental clinic permit shall have:</text> <paragraph num="(1)"> <text>A medical emergency plan;</text> </paragraph> <paragraph num="(2)"> <text>Adequate equipment, including:</text> <paragraph num="(a)"> <text>Portable equipment where appropriate; and</text> </paragraph> <paragraph num="(b)"> <text>Appropriate armamentarium available for the delivery of dental services; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Adequate safeguards to protect the health and safety of patients.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Display of Permit. The holder of a temporary dental clinic permit shall display the permit conspicuously in the clinic.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Board Authority."> <paragraph num="A."> <text>The Board may:</text> <paragraph num="(1)"> <text>Enter and inspect a temporary dental clinic in order to carry out a duty under Health Occupations Article, Title 4, Annotated Code of Maryland, or this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct an investigation of:</text> <paragraph num="(a)"> <text>A temporary dental clinic;</text> </paragraph> <paragraph num="(b)"> <text>A holder of a temporary volunteer dentist’s license providing services at a temporary dental clinic;</text> </paragraph> <paragraph num="(c)"> <text>A holder of a temporary volunteer dental hygienist’s license providing services at a temporary dental clinic;</text> </paragraph> <paragraph num="(d)"> <text>A holder of a general license to practice dentistry providing services at a temporary dental clinic; or</text> </paragraph> <paragraph num="(e)"> <text>A holder of a general license to practice dental hygiene providing services at a temporary dental clinic.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>This regulation may not be construed to limit the authority of the Board to conduct investigations under Health Occupations Article, Title 4, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-101, 4-304, 4-306, and 4-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 12, 2011 (38:25 Md. R. 1582)</annotation> </annotations> </chapter> <chapter num="34" heading="Inspections—Compliance with Centers for Disease Control and Prevention Guidelines"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The purpose of this chapter is to prescribe procedures for unannounced inspections of a dental office to determine compliance at that office with the Centers for Disease Control and Prevention's guidelines on universal precautions in accordance with the Health Occupations Article, §4-205(a)(6), Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Inspections."> <paragraph num="A."> <text>On receipt of a written and signed complaint, including a referral from the Commissioner of Labor and Industry, alleging potential non-compliance with the Centers for Disease Control and Prevention's guidelines on universal precautions, the Board may conduct an unannounced inspection of the dental office.</text> </paragraph> <paragraph num="B."> <text>A Board inspector or designee shall inspect the dental office in accordance with the Centers for Disease Control and Prevention's guidelines on universal precautions and shall produce an inspection report.</text> </paragraph> <paragraph num="C."> <text>The Board shall review the inspection report and make a determination as to whether any violations exist.</text> </paragraph> <paragraph num="D."> <text>Within 2 weeks of the inspection, the Board shall notify the appropriate licensee or licensees of the results of the inspection in writing. If the inspection found violations, the notification shall include a notice of those violations and the specified time to correct those violations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Correction of Violations."> <paragraph num="A."> <text>Except as provided in §§C and D of this regulation, if the Board’s inspection indicated violations, the appropriate licensee or licensees within the dental office shall correct violations within 30 days after receipt of the Board’s written notification.</text> </paragraph> <paragraph num="B."> <text>The Board may require less than 30 days to correct a violation if the Board considers the correction necessary to the interest of public health.</text> </paragraph> <paragraph num="C."> <text>A licensee may request an extension of time for correction of violations.</text> </paragraph> <paragraph num="D."> <text>The Board may approve or deny an extension of time for correction of violations.</text> </paragraph> <paragraph num="E."> <text>Upon completion of correction of all violations, the licensee shall notify the Board in writing within 1 week of the corrections with adequate documentation of all corrections.</text> </paragraph> <paragraph num="F."> <text>Upon notification of the corrections, the Board or its designee shall re-inspect the dental office.</text> </paragraph> <paragraph num="G."> <text>The Board shall notify the appropriate licensee or licensees in writing of the results of the re-inspection within 1 week of the re-inspection.</text> </paragraph> <paragraph num="H."> <text>If re-inspection reveals additional violations not cited in the first inspection report, the appropriate licensee or licensees shall correct those violations in the time period specified unless an extension of time is requested by a licensee and approved by the Board in accordance with §§C and D of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Penalties."> <paragraph num="A."> <text>Failure to allow an inspection of a dental office may result in disciplinary action against a licensee in accordance with COMAR 10.44.07, subject to the hearing requirements set forth in Health Occupations Article, §4-318, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Failure to comply with a notice to correct violations within a 30-day period, or any extension granted by the Board under Regulation .03 of this chapter, may result in disciplinary action against a licensee in accordance with COMAR 10.44.07, subject to the hearing requirements set forth in Health Occupations Article, §4-318, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Nothing in this chapter precludes the Board from taking concurrent or subsequent disciplinary action, including summary action, against a licensee found to have violated applicable Centers for Disease Control and Prevention guidelines, subject to the Administrative Procedure Act, the notice and hearing requirements set forth in Health Occupations Article, §4-318, Annotated Code of Maryland, and Board regulations.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-205(c)(1) and 4-205(a)(6), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 18, 2025 (52:16 Md. R. 847)</annotation> </annotations> </chapter> <chapter num="35" heading="Limited Dental Drug Dispensing Permits"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter covers the issuance by the State Board of Dental Examiners of a limited dental drug dispensing permit for dentists who wish to dispense only prescription strength:</text> <paragraph num="(1)"> <text>Home fluoride products;</text> </paragraph> <paragraph num="(2)"> <text>Dentin/enamel remineralizing products; or</text> </paragraph> <paragraph num="(3)"> <text>Antimicrobial rinses.</text> </paragraph> </paragraph> <paragraph num="B."> <text>This chapter does not apply to a dentist who dispenses prescription drugs in the course of treating a patient at a:</text> <paragraph num="(1)"> <text>Medical facility or clinic that is operated on a nonprofit basis;</text> </paragraph> <paragraph num="(2)"> <text>Health center that operates on a campus of an institution of higher learning;</text> </paragraph> <paragraph num="(3)"> <text>Public health facility;</text> </paragraph> <paragraph num="(4)"> <text>Medical facility under contract with the State or local health department: or</text> </paragraph> <paragraph num="(5)"> <text>Facility funded with public funds.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A dentist who dispenses a full course of antibiotics to a patient for infection control is not required to obtain a drug dispensing permit if the dispensing meets the requirements of Regulation .05A of this chapter.</text> </paragraph> <paragraph num="D."> <text>A dentist who wishes to dispense prescription drugs other than those covered in this chapter is required to obtain a drug dispensing permit as required by COMAR 10.13.01.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administer” means the direct introduction of a single dosage of a drug at a given time, whether by injection or other means, and whether in liquid, tablet, capsule, or other form.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland State Board of Dental Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Dentist” means an individual who holds a current license to practice dentistry in Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Limited dental drug dispensing permit” means a drug dispensing permit for dentists who wish to dispense only prescription strength:</text> <paragraph num="(a)"> <text>Home fluoride products;</text> </paragraph> <paragraph num="(b)"> <text>Dentin/enamel remineralizing products; or</text> </paragraph> <paragraph num="(c)"> <text>Antimicrobial rinses.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Starter dosage” means an amount of a drug sufficient to begin therapy:</text> <paragraph num="(a)"> <text>Of short duration of 72 hours or less; or</text> </paragraph> <paragraph num="(b)"> <text>Before obtaining a large quantity of the drug to complete the therapy.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Permit Required."> <text>Subject to the exception contained in Regulation .05 of this chapter, a dentist may not dispense home fluoride products, dentin/remineralizing products or antimicrobial rinses unless the dentist holds a limited drug dispensing permit issued by the Board.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Issuance and Renewal of Permit."> <paragraph num="A."> <text>A permit expires on October 1 of the 5th year following the effective date of the permit.</text> </paragraph> <paragraph num="B."> <text>To obtain a permit, a dentist shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on a form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pay the fee set by the Board in COMAR 10.44.20.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall mail a renewal application to each dentist holding a limited dental drug dispensing permit at least 90 days before the expiration of the permit.</text> </paragraph> <paragraph num="D."> <text>Before the permit expires, an applicant may apply to renew the permit for an additional 5-year term if the applicant:</text> <paragraph num="(1)"> <text>Submits to the Board a renewal application on a form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pays the renewal fee set by the Board in COMAR 10.44.20.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Exceptions."> <paragraph num="A."> <text>Drug Samples. A dentist is not required to have a limited dental drug dispensing permit to dispense drug samples if:</text> <paragraph num="(1)"> <text>The sample complies with the labeling requirements contained in Health Occupations Article, §12-505, Annotated Code of Maryland, except that the labeling requirements may not apply if the dentist dispenses the drug:</text> <paragraph num="(a)"> <text>In an emergency situation; or</text> </paragraph> <paragraph num="(b)"> <text>As a sample dispensed in the regular course of the dentist’s practice;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>No charge is made for the sample; and</text> </paragraph> <paragraph num="(3)"> <text>The dentist enters an appropriate record in the patient’s chart.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Starter Dosages. A dentist is not required to have a limited dental drug dispensing permit to dispense starter dosages if:</text> <paragraph num="(1)"> <text>The starter dosage complies with the labeling requirements contained in Health Occupations Article, §12-505, Annotated Code of Maryland, except that the labeling requirements may not apply if the dentist dispenses the drug:</text> <paragraph num="(a)"> <text>In an emergency situation; or</text> </paragraph> <paragraph num="(b)"> <text>As a starter dosage dispensed in the regular course of the dentist’s practice;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>No charge is made for the starter dosage; and</text> </paragraph> <paragraph num="(3)"> <text>The dentist enters an appropriate record in the patient’s chart.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Course of Treating a Patient. A dentist is not required to have a limited drug dispensing permit to administer a prescription drug in the course of treating a patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Violations."> <paragraph num="A."> <text>After an opportunity for a hearing, the Board may revoke or suspend a limited permit or take disciplinary action under Health Occupations Article, §4-315(a) or (b), Annotated Code of Maryland, if the Board finds that the holder of the permit violates any provision of this chapter.</text> </paragraph> <paragraph num="B."> <text>Failure to comply with the provisions of this chapter constitutes unprofessional conduct and may constitute other violations of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a Permit."> <paragraph num="A."> <text>The Board may order the summary suspension of a permit if the Board:</text> <paragraph num="(1)"> <text>Finds that the public health, safety, or welfare imperatively requires emergency action; and</text> </paragraph> <paragraph num="(2)"> <text>Promptly gives the licensee:</text> <paragraph num="(a)"> <text>Written notice of the suspension, the finding, and the reasons that support the finding; and</text> </paragraph> <paragraph num="(b)"> <text>An opportunity to be heard.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Service of the notice of the suspension, the finding, the reasons that support the finding, and the notice of the opportunity to be heard may be effected upon the holder of a permit by:</text> <paragraph num="(1)"> <text>Personal service; or</text> </paragraph> <paragraph num="(2)"> <text>Written notice sent by certified mail and regular mail to the permit holder’s address on file with the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Service made pursuant to §B(2) of this regulation shall be effective upon mailing.</text> </paragraph> <paragraph num="D."> <text>The methods of service provided in this regulation are in addition to and not exclusive of any other means of service that are reasonably calculated to provide notice.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §4-207(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 20, 2015 (42:14 Md. R. 880)</annotation> </annotations> </chapter> <chapter num="36" heading="Private Dental Offices—Infection Control"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“CDC Guidelines” means the Centers for Disease Control and Prevention Guidelines for Infection Control in Dental Health-Care Settings—2003.</text> </paragraph> <paragraph num="(2)"> <text>“Practice dentistry” has the meaning stated in Health Occupations Article, §4-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Private dental office” has the meaning stated in Health Occupations Article, §4-308, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Standard and transmission based precautions” means the minimum infection control prevention practices that apply to all patient care, regardless of suspected or confirmed infection status of the patient, in any setting where health care is delivered.</text> </paragraph> <paragraph num="(5)"> <text>“Supervising dentist” means a dentist licensed in the State, including a solo practitioner, who is responsible for all infection control activities within a private dental office as set forth in this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporation by Reference."> <text>Guidelines for Infection Control in Dental Health-Care Settings—2003 (Morbidity and Mortality Weekly Report (MMWR): Recommendations and Reports, 2003; v. 52; no. 17, Centers for Disease Control and Prevention (CDC, Atlanta, GA)) is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Supervising Dentist—Board Registration."> <paragraph num="A."> <text>Each owner of a private dental office shall designate a licensed dentist to be the supervising dentist for the private dental office.</text> </paragraph> <paragraph num="B."> <text>A supervising dentist designated under §A of this regulation shall:</text> <paragraph num="(1)"> <text>Complete the registration required by the Board on a form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Be responsible for all infection control activities within the private dental office.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a supervising dentist for a private dental office relinquishes the supervising dentist’s responsibilities under §B(2) of this regulation, for any reason, the owner of the private dental office shall immediately designate an interim supervising dentist who shall be responsible for all infection control within the private dental office until a new supervising dentist for the private dental office registers with the Board.</text> </paragraph> <paragraph num="D."> <text>An interim supervising dentist may remain an interim supervising dentist for no more than 45 calendar days prior to the registration of a subsequent supervising dentist.</text> </paragraph> <paragraph num="E."> <text>The responsibilities of a supervising dentist set forth in this regulation is not considered the practice of dentistry.</text> </paragraph> <paragraph num="F."> <text>This regulation may not be construed to prevent an unlicensed individual from assisting with regulatory compliance consistent with Health Occupations Article, §4-103(e)(12), Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>The Board may charge a fee not to exceed the fee set forth in COMAR 10.44.20 for the registration and any subsequent registrations of supervising dentists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Display of Registration."> <text>The owner of a private dental office shall display the name of the supervising dentist and the name of the interim supervising dentist, if applicable, conspicuously in the office on the form provided by the Board.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Supervising Dentist—Infection Control Activities."> <paragraph num="A."> <text>The supervising dentist in a private dental office shall be responsible for the following infection control activities:</text> <paragraph num="(1)"> <text>Adherence to the CDC Guidelines in their individual capacity as described in Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The provision and accessibility of sufficient and appropriate:</text> <paragraph num="(a)"> <text>Personal protective equipment including but not limited to:</text> <paragraph num="(i)"> <text>Gloves;</text> </paragraph> <paragraph num="(ii)"> <text>Masks;</text> </paragraph> <paragraph num="(iii)"> <text>Eyewear; and</text> </paragraph> <paragraph num="(iv)"> <text>Gowns;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Hand soaps and hand scrubs;</text> </paragraph> <paragraph num="(c)"> <text>Puncture-resistant sharps containers located in close proximity to where they are to be used;</text> </paragraph> <paragraph num="(d)"> <text>Products for cleaning and disinfecting environmental surfaces that are approved by the Environmental Protection Agency or its successor;</text> </paragraph> <paragraph num="(e)"> <text>Periodic water quality testing to ensure that water meets Environmental Protection Agency regulatory standards for drinking water;</text> </paragraph> <paragraph num="(f)"> <text>Sterilization monitoring of reusable dental equipment and instruments in accordance with the manufacturer’s instructions for use, including:</text> <paragraph num="(i)"> <text>Biological spore testing;</text> </paragraph> <paragraph num="(ii)"> <text>Chemical monitoring; and</text> </paragraph> <paragraph num="(iii)"> <text>Mechanical monitoring;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Maintenance of a biohazard waste removal contract for the office; and</text> </paragraph> <paragraph num="(h)"> <text>Signage for patient waiting areas for those exhibiting symptoms of respiratory infection.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the activities set forth in §A of this regulation, a supervising dentist shall be responsible for the training of clinical staff upon hire and before engaging in clinical duties, and at minimum, annually.</text> </paragraph> <paragraph num="C."> <text>The training of clinical staff shall include training regarding:</text> <paragraph num="(1)"> <text>Standard and transmission based precautions;</text> </paragraph> <paragraph num="(2)"> <text>Hand hygiene;</text> </paragraph> <paragraph num="(3)"> <text>Personal protective equipment;</text> </paragraph> <paragraph num="(4)"> <text>Respiratory hygiene/cough etiquette;</text> </paragraph> <paragraph num="(5)"> <text>Sharps safety;</text> </paragraph> <paragraph num="(6)"> <text>Safe injection practices;</text> </paragraph> <paragraph num="(7)"> <text>Sterilizing and disinfecting clinical contact and housekeeping surfaces;</text> </paragraph> <paragraph num="(8)"> <text>Spore testing;</text> </paragraph> <paragraph num="(9)"> <text>Water quality testing; and</text> </paragraph> <paragraph num="(10)"> <text>The Occupational Safety and Health Administration Bloodborne Pathogens Standard as set forth in 29 C.F.R. §1910.1030.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervising dentist shall ensure that evidence-based written policies and procedures, based upon current CDC Guidelines, regulatory requirements, and other relevant guidance documents, are developed, maintained, and readily available for review by the office’s clinical staff.</text> </paragraph> <paragraph num="E."> <text>The policies and procedures referred to in §D of this regulation shall be updated either annually or more often if appropriate, to reflect new evidence, guidelines, or regulatory requirements.</text> </paragraph> <paragraph num="F."> <text>A supervising dentist shall maintain adequate written records of the activities set forth in §§A—E of this regulation in each office for which the records apply.</text> </paragraph> <paragraph num="G."> <text>A supervising dentist who practices clinical dentistry shall, for their own practice of dentistry, be responsible for all infection control activities in the dental office including those activities that are not considered structural infection control or those that do not impact the entirety of the private dental office.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Individual Dentist Responsibilities."> <text>Notwithstanding the responsibilities of a supervising dentist set forth in Regulation .05 of this chapter, an individual dentist who is not a supervising dentist shall be responsible for infection control activities in the control of the individual dentist including:</text> <paragraph num="A."> <text>Use of adequate personal protective equipment; and</text> </paragraph> <paragraph num="B."> <text>Sterilization of instruments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Violations."> <text>Violations of this chapter constitutes unprofessional conduct and may result in disciplinary action against a dentist as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§4-104 and 4-205(c)(1)(v), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 19, 2026 (53:1 Md. R. 23))</annotation> </annotations> </chapter> </subtitle> <subtitle num="45" heading="Maryland Community Health Resources Commission"> <chapter num="01" heading="Purpose and Definitions"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <paragraph num="A."> <text>The purpose of the Commission is, through community health resources, to:</text> <paragraph num="(1)"> <text>Increase access to health care services;</text> </paragraph> <paragraph num="(2)"> <text>Redirect nonemergency emergency room use to community health resources;</text> </paragraph> <paragraph num="(3)"> <text>Develop coordinated, integrated systems of community-based care; and</text> </paragraph> <paragraph num="(4)"> <text>Assist patients in establishing a medical home with a community health resource.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A key objective of the Commission is to reduce health disparities in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a person that submits to the Commission, within the time period specified by the Commission:</text> <paragraph num="(a)"> <text>A letter of intent to submit a grant application under this subtitle; or</text> </paragraph> <paragraph num="(b)"> <text>A grant application under this subtitle.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Application” means a document:</text> <paragraph num="(a)"> <text>Prepared by an applicant in response to the Commission's call for proposals; and</text> </paragraph> <paragraph num="(b)"> <text>That includes the elements specified in COMAR 10.45.06.03.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Call for proposals” means a document issued by the Commission that:</text> <paragraph num="(a)"> <text>Invites members of the public to develop and submit proposals for projects and programs for which grant funding under this subtitle is sought;</text> </paragraph> <paragraph num="(b)"> <text>Specifies the required content of a grant application and proposal; and</text> </paragraph> <paragraph num="(c)"> <text>Identifies selection criteria and funding priorities to be applied by the Commission in determining which proposals will be funded.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Commission” means the Maryland Community Health Resources Commission.</text> </paragraph> <paragraph num="(5)"> <text>“Commissioner” means a member of the Commission.</text> </paragraph> <paragraph num="(6)"> <text>“Community health center” means a community-based health center that serves underserved populations and is grant-funded under §330(e) of the Public Health Service Act.</text> </paragraph> <paragraph num="(7)"> <text>“Community health resource” means a person determined by the Commission to satisfy the criteria set forth in COMAR 10.45.05.02, .03, or .04.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Developmental Disabilities Administration (DDA) licensee” has the meaning stated in COMAR 10.22.01.01B(36).</text> </paragraph> <paragraph num="(10)"> <text>“Federal poverty guidelines” means the poverty measure that is:</text> <paragraph num="(a)"> <text>Issued annually in the Federal Register by the U. S. Department of Health and Human Services; and</text> </paragraph> <paragraph num="(b)"> <text>Used to determine eligibility for government programs.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Federally qualified health center” has the meaning stated in Health-General Article, §24-1301(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Federally qualified health center 'look-alike'” means a community-based health center that:</text> <paragraph num="(a)"> <text>Is authorized under §1905(l)(2)(B)(iii) of the Social Security Act; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the eligibility requirements for a grant under §330 of the Public Health Service Act (42 U.S.C. 254b), but is not a grantee.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Fiscal year (FY)” has the meaning stated in COMAR 10.09.62.01B.</text> </paragraph> <paragraph num="(14)"> <text>“Health care program for the homeless” means a community-based health center that:</text> <paragraph num="(a)"> <text>Serves homeless adults and children; and</text> </paragraph> <paragraph num="(b)"> <text>Is grant-funded under §330(h) of the Public Health Service Act (42 U.S.C. 254b(h)).</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Health center controlled operating network” means an entity funded or otherwise charged by the federal Health Resources and Services Administration (HRSA) to develop, operate, or enhance safety net provider networks so as to:</text> <paragraph num="(a)"> <text>Improve health care access for the medically underserved;</text> </paragraph> <paragraph num="(b)"> <text>Develop and operate safety net provider networks; and</text> </paragraph> <paragraph num="(c)"> <text>Increase health centers' efficiency, revenue, and overall productivity.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Historic Maryland primary care provider” means a person that provided primary care services through the Maryland PrimaryCare Program.</text> </paragraph> <paragraph num="(17)"> <text>“Local health department” has the meaning stated in COMAR 10.09.40.01.</text> </paragraph> <paragraph num="(18)"> <text>“Local nonprofit and community-owned health care program” means a collaboration of local public or private nonprofit health care programs, or both, to provide or coordinate free or reduced-cost health care services for low-income or uninsured individuals, such as:</text> <paragraph num="(a)"> <text>County community action agencies established under the Economic Opportunity Act of 1964;</text> </paragraph> <paragraph num="(b)"> <text>Partnerships of public or private nonprofit health care providers or programs providing case management or other care coordination services;</text> </paragraph> <paragraph num="(c)"> <text>Private nonprofit programs that provide administrative, support, and coordination services to facilitate the provision of primary and specialty care services by volunteer practitioners; and</text> </paragraph> <paragraph num="(d)"> <text>Community outreach programs sponsored by a local health department.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Maryland PrimaryCare Program” means the State-funded initiative, governed by COMAR 10.51.01 — .11, providing office-based primary care to qualifying low-income adults.</text> </paragraph> <paragraph num="(20)"> <text>“Migrant health center” means a community-based health center that:</text> <paragraph num="(a)"> <text>Is grant-funded under §330(g) of the Public Health Service Act (42 U.S.C. 254b(g)); and</text> </paragraph> <paragraph num="(b)"> <text>Serves migratory and seasonal farm workers and their families in the State.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Outpatient mental health clinic” has the meaning stated in COMAR 10.21.17.02.</text> </paragraph> <paragraph num="(22)"> <text>“Person” has the meaning stated in Health-General Article, §1-101(h), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Practitioner” has the meaning stated in COMAR 10.09.62.01B.</text> </paragraph> <paragraph num="(24)"> <text>“Presiding officer” means:</text> <paragraph num="(a)"> <text>The chair of the Commission; or</text> </paragraph> <paragraph num="(b)"> <text>In the chair's absence, the chair's designee.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Primary care program for a public housing project” means a community-based health center that:</text> <paragraph num="(a)"> <text>Provides comprehensive primary care services to public housing residents; and</text> </paragraph> <paragraph num="(b)"> <text>Is grant-funded under §330(i) of the Public Health Service Act (42 U.S.C. 254b(i)).</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“School-based health center” means a provider located on school grounds that the Secretary has designated a school-based health center as specified in COMAR 10.09.68.02.</text> </paragraph> <paragraph num="(28)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(29)"> <text>“State” means the State of Maryland.</text> </paragraph> <paragraph num="(30)"> <text>“Substance abuse treatment provider” means a provider of substance abuse treatment services that is:</text> <paragraph num="(a)"> <text>Located in the State; and</text> </paragraph> <paragraph num="(b)"> <text>Certified in accordance with Health-General Article, §8-404, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Teaching clinic” means a provider in the State that is staffed in part by practitioners participating in accredited clinical training programs for health professionals, including, but not limited to:</text> <paragraph num="(a)"> <text>Physicians;</text> </paragraph> <paragraph num="(b)"> <text>Nurses; and</text> </paragraph> <paragraph num="(c)"> <text>Dentists.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Wellmobile” means a mobile health clinic in the Governor's Wellmobile Program, established under the Health-General Article, §§13-1301 — 13-1303, Annotated Code of Maryland, within the University of Maryland School of Nursing, that:</text> <paragraph num="(a)"> <text>Delivers primary and preventive health care services to geographically underserved communities and uninsured individuals in the State; and</text> </paragraph> <paragraph num="(b)"> <text>Provides principal training sites for the University of Maryland School of Nursing to expand student learning opportunities.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .02 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 23, 2012 (39:14 Md. R. 838)</annotation> </annotations> </chapter> <chapter num="02" heading="Officers and Staff"> <regulation prefix="Regulation" num=".01" heading="Commission Chair."> <paragraph num="A."> <text>The chair is appointed by the Governor.</text> </paragraph> <paragraph num="B."> <text>Duties. The chair shall:</text> <paragraph num="(1)"> <text>Except as provided in §B(6)(b) of this regulation, convene and preside over the meetings of the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Call meetings of the Commission as necessary to accomplish the Commission's purpose;</text> </paragraph> <paragraph num="(3)"> <text>Appoint the Commission's vice chair;</text> </paragraph> <paragraph num="(4)"> <text>Appoint the chairs of the Commission's standing and ad hoc committees;</text> </paragraph> <paragraph num="(5)"> <text>Appoint the members of the Commission's committees; and</text> </paragraph> <paragraph num="(6)"> <text>At meetings of the Commission, either:</text> <paragraph num="(a)"> <text>Serve as the presiding officer; or</text> </paragraph> <paragraph num="(b)"> <text>Designate the vice chair or other commissioner to preside over any Commission meeting the chair is unable to attend.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Commissioners."> <text>The Commission consists of 11 members, appointed by the Governor, with the advice and consent of the Senate, in accordance with Health-General Article, §19-2103, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Executive Director and Staff."> <paragraph num="A."> <text>Executive Director. The Executive Director of the Commission:</text> <paragraph num="(1)"> <text>Is the chief administrative officer of the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Is appointed by the Commission with the approval of the Governor;</text> </paragraph> <paragraph num="(3)"> <text>Serves at the pleasure of the Commission; and</text> </paragraph> <paragraph num="(4)"> <text>Shall, under the direction of the Commission, perform any duty or function that the Commission requires, consistent with Health-General Article, §§19-2101 — 2201, Annotated Code of Maryland, and this subtitle.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Staff.</text> <paragraph num="(1)"> <text>The Commission may employ a staff in accordance with the State budget.</text> </paragraph> <paragraph num="(2)"> <text>The Commission, in consultation with the Secretary, shall determine appropriate job classifications and grades for all staff.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §19-2107, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="03" heading="Committees"> <regulation prefix="Regulation" num=".01" heading="Standing Committees."> <paragraph num="A."> <text>The four standing committees of the Commission are:</text> <paragraph num="(1)"> <text>The Committee on Capital and Operational Funding;</text> </paragraph> <paragraph num="(2)"> <text>The Committee on Hospital and Community Health Resources Relations;</text> </paragraph> <paragraph num="(3)"> <text>The Committee on School-Based Community Health Clinic Center Expansion; and</text> </paragraph> <paragraph num="(4)"> <text>The Committee on Data Information Systems.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Committee Appointment. The chair shall appoint commissioners to serve on the standing committees annually, at the first regularly scheduled Commission meeting of each fiscal year.</text> </paragraph> <paragraph num="C."> <text>Vacancies. The chair may appoint commissioners to fill vacancies on the committees at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Ad Hoc Committees."> <paragraph num="A."> <text>The Commission may establish one or more ad hoc committees to assist in performing duties of the Commission.</text> </paragraph> <paragraph num="B."> <text>An ad hoc committee established pursuant to §A of this regulation shall:</text> <paragraph num="(1)"> <text>Limit its activities to the purpose for which it was formed; and</text> </paragraph> <paragraph num="(2)"> <text>Be dissolved when the purpose for which it was formed has been satisfied or abandoned by the Commission.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107 and 19-2110, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="04" heading="Meetings"> <regulation prefix="Regulation" num=".01" heading="Meetings; Procedure."> <paragraph num="A."> <text>Meetings of the Commission and meetings of the standing committees specified in COMAR 10.45.03.01 shall be governed in accordance with:</text> <paragraph num="(1)"> <text>Maryland's Open Meetings Act; and</text> </paragraph> <paragraph num="(2)"> <text>Commonly accepted rules of parliamentary procedure as determined by the chair.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the full authorized membership of the Commission is a quorum.</text> </paragraph> <paragraph num="(2)"> <text>A quorum need not be present in order for the Commission to hold a meeting.</text> </paragraph> <paragraph num="(3)"> <text>If less than a quorum is present at any meeting, the presiding officer shall defer matters submitted for a vote until a quorum is present.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Voting.</text> <paragraph num="(1)"> <text>Each commissioner shall be entitled to one vote on each matter submitted to a vote at the meeting.</text> </paragraph> <paragraph num="(2)"> <text>Voting shall be in person or by proxy.</text> </paragraph> <paragraph num="(3)"> <text>The Commission may not act on any matter unless at least six members in attendance concur.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Minutes. The Commission shall ensure that minutes of its public meetings are:</text> <paragraph num="(1)"> <text>Recorded;</text> </paragraph> <paragraph num="(2)"> <text>Presented to the Commission for approval; and</text> </paragraph> <paragraph num="(3)"> <text>Made available for public inspection at the offices of the Commission during ordinary business hours.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Frequency of Meetings."> <paragraph num="A."> <text>Subject to §B of this regulation, public meetings of the Commission may be held for any authorized purpose, at a time and location determined by the Commission.</text> </paragraph> <paragraph num="B."> <text>The Commission shall meet at least six times per year.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2106 and 19-2107, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="05" heading="Community Health Resources"> <regulation prefix="Regulation" num=".01" heading="Qualification as Community Health Resource."> <paragraph num="A."> <text>To qualify as a community health resource, a person shall demonstrate that the person meets the criteria set forth in Regulation .02, .03, or .04 of this chapter.</text> </paragraph> <paragraph num="B."> <text>Regardless of the community health resource category for which an applicant submits evidence of qualification, the Commission may determine that the applicant meets the criteria to qualify as a community health resource under either Regulation 02, .03, or .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualification under Health-General Article, §19-2101(c)(1), Annotated Code of Maryland — Primary Health Care Services."> <paragraph num="A."> <text>Criteria. To qualify as a community health resource pursuant to this regulation and Health-General Article, §19-2101(c)(1), Annotated Code of Maryland, a person shall demonstrate that the person:</text> <paragraph num="(1)"> <text>Is a nonprofit or for-profit health care center or program;</text> </paragraph> <paragraph num="(2)"> <text>Provides primary health care services:</text> <paragraph num="(a)"> <text>In accordance with a sliding scale fee schedule payment policy that is consistent with the guidelines set forth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Without regard to an individual's ability to pay; and</text> </paragraph> <paragraph num="(c)"> <text>Primarily to Maryland residents from service sites located within the State; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provides medical care to address a patient's general health needs, including:</text> <paragraph num="(a)"> <text>Promotion and maintenance of the patient's health;</text> </paragraph> <paragraph num="(b)"> <text>Treatment of illness;</text> </paragraph> <paragraph num="(c)"> <text>Prevention of disease;</text> </paragraph> <paragraph num="(d)"> <text>Maintenance of the patient's health records; and</text> </paragraph> <paragraph num="(e)"> <text>Making referrals for medically necessary and appropriate specialty care services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Submission Requirements. To demonstrate qualification as a community health resource under this regulation, a person shall submit, on or before the date and time specified by the Commission, the information and documentation that the person meets the criteria set forth in §A of this regulation, including:</text> <paragraph num="(1)"> <text>A written statement that includes the applicant's name, the addresses of all its service locations, and a description of how the applicant meets the requirements of §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the applicant's written procedures for consistent application of the applicant's policies concerning:</text> <paragraph num="(a)"> <text>Uncompensated care;</text> </paragraph> <paragraph num="(b)"> <text>Its sliding scale fee schedule, consistent with the requirements of Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Provision of services regardless of a patient's ability to pay;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A list of services offered by the applicant;</text> </paragraph> <paragraph num="(4)"> <text>A calculation of the proportion of patients served by the applicant who are Maryland residents;</text> </paragraph> <paragraph num="(5)"> <text>An explanation of how the services offered by the applicant are provided, specifying practitioners' licensure categories, such as physician, nurse-practitioner, or other; and</text> </paragraph> <paragraph num="(6)"> <text>Upon the Commission's request, any additional information the Commission requires to complete its determination.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission shall determine that a person does not qualify as a community health resource pursuant to this regulation if:</text> <paragraph num="(1)"> <text>Unless COMAR 10.45.08.01G applies, the person does not submit to the Commission, on or before the date and time specified by the Commission, the documentation required by §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The Commission requests additional information or materials pursuant to COMAR 10.45.08.01G, and:</text> <paragraph num="(a)"> <text>The person does not submit the information or materials requested by the Commission within the time allowed; or</text> </paragraph> <paragraph num="(b)"> <text>The additional information and material submitted by the person do not establish the person's qualification as a community health resource; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission determines that the person does not meet the qualification criteria specified in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualification under Health-General Article, §19-2101(c)(2), Annotated Code of Maryland — Access Services."> <paragraph num="A."> <text>To qualify as a community health resource pursuant to this regulation and Health-General Article, §19-2101(c)(2), Annotated Code of Maryland, a person shall demonstrate that the person:</text> <paragraph num="(1)"> <text>Is a nonprofit or for-profit health care center or program;</text> </paragraph> <paragraph num="(2)"> <text>Offers access services that:</text> <paragraph num="(a)"> <text>Directly assist low-income, uninsured, or underinsured individuals to gain access to reduced-price clinical health care services; and</text> </paragraph> <paragraph num="(b)"> <text>May include, but are not limited to:</text> <paragraph num="(i)"> <text>Coordination of patients' health care;</text> </paragraph> <paragraph num="(ii)"> <text>Case management services; and</text> </paragraph> <paragraph num="(iii)"> <text>Transportation of patients to and from medical appointments; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Offers access services, as described in §A(2) of this regulation:</text> <paragraph num="(a)"> <text>Without regard to an individual's ability to pay;</text> </paragraph> <paragraph num="(b)"> <text>In accordance with a sliding scale fee schedule that is consistent with the guidelines set forth in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Primarily to Maryland residents from service sites located within the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Nonqualifying Services.</text> <paragraph num="(1)"> <text>Services not directly assisting patients to access clinical health care services are not access services and do not establish a person's qualification as a community health resource pursuant to this regulation and Health-General Article, §19-2101(c)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Examples of services that do not qualify as access services include, but are not limited to:</text> <paragraph num="(a)"> <text>Transportation to health fairs or wellness lectures;</text> </paragraph> <paragraph num="(b)"> <text>Mass mailings of health educational materials; or</text> </paragraph> <paragraph num="(c)"> <text>Promotional activities sponsored by health care providers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To demonstrate qualification as a provider of access services, a person shall submit, on or before the date and time specified by the Commission, the information and documentation that the person meets the criteria set forth in §A of this regulation, including:</text> <paragraph num="(1)"> <text>A written statement that includes the applicant's name, the addresses of all its service locations, and a description of how the applicant meets the requirements of §A of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the applicant's written procedures for consistent application of the applicant's policies concerning its:</text> <paragraph num="(a)"> <text>Sliding scale fee schedule; and</text> </paragraph> <paragraph num="(b)"> <text>Provision of services regardless of a patient's ability to pay;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A list of services offered by the applicant;</text> </paragraph> <paragraph num="(4)"> <text>A calculation of the proportion of patients served by the applicant who are Maryland residents; and</text> </paragraph> <paragraph num="(5)"> <text>Upon the Commission's request, any additional information the Commission requires to complete its determination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Commission shall determine that a person does not qualify as a community health resource under this regulation if:</text> <paragraph num="(1)"> <text>Except when the Commission requests additional information or materials pursuant to COMAR 10.45.08.01G, the person does not submit to the Commission, on or before the date and time specified by the Commission, the documentation required by §C of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The Commission requests additional information or materials pursuant to COMAR 10.45.08.01G, and:</text> <paragraph num="(a)"> <text>The person does not submit the information or materials requested by the Commission within the time allowed; or</text> </paragraph> <paragraph num="(b)"> <text>The additional information and material submitted by the person do not establish the person's qualification as a community health resource; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission determines that the person does not meet the qualification criteria specified in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualification under Health-General Article, §19-2101(c)(2), Annotated Code of Maryland — Designee Services."> <paragraph num="A."> <text>To qualify as a community health resource designated pursuant to this regulation and Health-General Article, §19-2101(c)(2), Annotated Code of Maryland, a person shall establish that the person meets the definition in COMAR 10.45.01.02 of a:</text> <paragraph num="(1)"> <text>Federally qualified health center;</text> </paragraph> <paragraph num="(2)"> <text>Federally qualified health center “look-alike”;</text> </paragraph> <paragraph num="(3)"> <text>Community health center;</text> </paragraph> <paragraph num="(4)"> <text>Migrant health center;</text> </paragraph> <paragraph num="(5)"> <text>Health care program for the homeless;</text> </paragraph> <paragraph num="(6)"> <text>Primary care program for a public housing project;</text> </paragraph> <paragraph num="(7)"> <text>Local nonprofit and community-owned health care program;</text> </paragraph> <paragraph num="(8)"> <text>School-based health center;</text> </paragraph> <paragraph num="(9)"> <text>Teaching clinic;</text> </paragraph> <paragraph num="(10)"> <text>Wellmobile;</text> </paragraph> <paragraph num="(11)"> <text>Health-center controlled operating network;</text> </paragraph> <paragraph num="(12)"> <text>Historic Maryland primary care provider;</text> </paragraph> <paragraph num="(13)"> <text>Outpatient mental health clinic;</text> </paragraph> <paragraph num="(14)"> <text>Local health department;</text> </paragraph> <paragraph num="(15)"> <text>Substance abuse treatment provider; or</text> </paragraph> <paragraph num="(16)"> <text>DDA licensee for FY 2012 and FY 2013.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To demonstrate that a person is a community health resource under this regulation, the person shall submit, on or before the date and time specified by the Commission, documentation establishing that the person meets the definitional criteria specified in COMAR 10.45.01.02 for a community health resource listed in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>Except as provided in §D of this regulation, a person listed in §A of this regulation qualifies as a community health resource without regard to the sliding scale fee schedule requirements specified in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Commission shall determine that a person does not qualify as a community health resource under Regulation .04 of this chapter if:</text> <paragraph num="(1)"> <text>Except when the Commission requests additional information or materials to aid in making a determination pursuant to COMAR 10.45.08.01G, the person does not submit to the Commission, on or before the date and time specified by the Commission, the documentation required by §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>The Commission requests additional information or materials pursuant to COMAR 10.45.08.01G, and:</text> <paragraph num="(a)"> <text>The person does not submit the information or materials requested by the Commission within the time allowed; or</text> </paragraph> <paragraph num="(b)"> <text>The additional information and material submitted by the person do not establish the person's qualification as a community health resource; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission determines that the person does not meet the definition, as specified in COMAR 10.45.01.02, of a provider category listed in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Sliding Scale Fee Schedule Guidelines."> <paragraph num="A."> <text>Applicability. The Commission shall apply the sliding scale fee schedule criteria set forth in §B of this regulation to determine whether:</text> <paragraph num="(1)"> <text>An applicant meets the sliding scale fee schedule criterion to qualify as a community health resource under Regulation .02A(2) or .03A(3) of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An application submitted by a community health resource addresses the selection criterion specified in COMAR 10.45.07.01I.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A community health resource shall offer primary health care services or access services to individuals whose annual family income is:</text> <paragraph num="(1)"> <text>Below 100 percent of the federal poverty guidelines:</text> <paragraph num="(a)"> <text>Free of charge; or</text> </paragraph> <paragraph num="(b)"> <text>For no more than a nominal fee; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 100 percent of the federal poverty guidelines but less than 200 percent of the federal poverty guidelines:</text> <paragraph num="(a)"> <text>Free of charge; or</text> </paragraph> <paragraph num="(b)"> <text>At a reduced price.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A community health resource qualifying under Regulation .02 or .03 of this chapter may not require individuals with annual family income of less than 200 percent of the federal poverty guidelines to pay any charges for primary health care services or access services in addition to those specified in §B(1) or (2) of this regulation, as applicable.</text> </paragraph> <paragraph num="D."> <text>Notice and Documentation. At each of its care sites in the State, a community health resource qualifying under Regulation .02 or .03 of this chapter shall:</text> <paragraph num="(1)"> <text>Provide notice to the public of its sliding scale fee schedule, including the display of a prominently posted sign indicating that free or reduced-price care is available; and</text> </paragraph> <paragraph num="(2)"> <text>Collect documentation of income from individuals applying for reduced-price care pursuant to the community health resource's sliding scale fee schedule.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 23, 2012 (39:14 Md. R. 838)</annotation> </annotations> </chapter> <chapter num="06" heading="Community Health Resource Grants"> <regulation prefix="Regulation" num=".01" heading="Call for Proposals."> <text>Beginning in FY 2007, the Commission shall issue to the public, at least once per year, and as budgeted resources permit, a call for proposals, which may include:</text> <paragraph num="A."> <text>An explanation of the grants program;</text> </paragraph> <paragraph num="B."> <text>A statement of the Commission's authority to make grant awards pursuant to Health-General Article, §19-2201(e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>An indication of whether the object of the solicitation is to award:</text> <paragraph num="(1)"> <text>Operating grants to qualifying community health resources; or</text> </paragraph> <paragraph num="(2)"> <text>Funding for development, support, and monitoring of a unified data information system among primary and specialty care providers, hospitals, and other providers of services to community health resource members;</text> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the statement under §C of this regulation, a specific indication of the types of programs the Commission expects to fund and the amount of grant funds to be awarded;</text> </paragraph> <paragraph num="E."> <text>Requirements relating to submission of community health resources qualifications, including a requirement that the materials necessary to establish an applicant's qualification as a community health resource pursuant to COMAR 10.45.05.02, .03, or .04 be submitted:</text> <paragraph num="(1)"> <text>As part of an applicant's letter of intent, pursuant to COMAR 10.45.06.02; or</text> </paragraph> <paragraph num="(2)"> <text>As part of an applicant's grant application, pursuant to COMAR 10.45.06.03;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Requirements applicable to letters of intent, if required, and grant applications, including:</text> <paragraph num="(1)"> <text>The content required for letters of intent under Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The content required for grant applications under Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Formatting guidelines; and</text> </paragraph> <paragraph num="(4)"> <text>The date and time for submission, the address to which letters of intent or grant applications shall be directed, and a specification of acceptable means of transmission;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Guidelines for preparing grant proposals, including requirements as to:</text> <paragraph num="(1)"> <text>The content of the proposal, consistent with Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The proposal's structure and organization;</text> </paragraph> <paragraph num="(3)"> <text>Questions to be addressed in the proposal; and</text> </paragraph> <paragraph num="(4)"> <text>Formatting and page limit requirements;</text> </paragraph> </paragraph> <paragraph num="H."> <text>An explanation of how grantees may use grant funds, consistent with COMAR 10.45.08.04;</text> </paragraph> <paragraph num="I."> <text>Budget guidelines; and</text> </paragraph> <paragraph num="J."> <text>To guide the applicant's preparation of the evaluation plan required by Regulation .04G of this chapter, an explanation of program monitoring and evaluation requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Letter of Intent."> <paragraph num="A."> <text>The Commission may require that, as a condition of submitting a grant application, a person first respond to the Commission's call for proposals by submitting a letter of intent to the address and by the date and time specified in the call for proposals.</text> </paragraph> <paragraph num="B."> <text>The Commission may, in its sole discretion, require that a letter of intent include information and documentation sufficient to establish a person's qualification as a community health resource as specified in COMAR 10.45.05.02, .03, or .04.</text> </paragraph> <paragraph num="C."> <text>If the Commission requires a letter of intent pursuant to §A of this regulation, an applicant shall include in the applicant's letter of intent, in addition to any content that may be required by the Commission pursuant to §B of this regulation:</text> <paragraph num="(1)"> <text>An identification of the type of grant, of those specified in the call for proposals pursuant to Regulation .01C of this chapter, for which the applicant intends to apply;</text> </paragraph> <paragraph num="(2)"> <text>A succinct description, no more than 250 words in length, of the proposed project;</text> </paragraph> <paragraph num="(3)"> <text>The estimated cost of the project and its expected duration;</text> </paragraph> <paragraph num="(4)"> <text>The name and location of the applicant;</text> </paragraph> <paragraph num="(5)"> <text>The name, title, address, telephone number, and email address of the proposed project director; and</text> </paragraph> <paragraph num="(6)"> <text>The name, affiliation, and email address of the applicant's contact person or persons.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>An application for a grant under this subtitle shall be submitted to the place and by the date and time specified in the call for proposals.</text> </paragraph> <paragraph num="B."> <text>As specified in the call for proposals, an application for a grant under this subtitle may be required to include the following elements:</text> <paragraph num="(1)"> <text>A transmittal letter:</text> <paragraph num="(a)"> <text>Specifying:</text> <paragraph num="(i)"> <text>The title of the proposal;</text> </paragraph> <paragraph num="(ii)"> <text>The name of the applicant;</text> </paragraph> <paragraph num="(iii)"> <text>The name of the project director; and</text> </paragraph> <paragraph num="(iv)"> <text>A statement that the applicant agrees that submission of a proposal constitutes the applicant's acceptance of the terms of the grant program; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Signed by an individual responsible for conducting the affairs of the applicant and legally authorized to execute contracts on behalf of the applicant;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A grant application cover sheet, on a form provided by the Commission and signed by:</text> <paragraph num="(a)"> <text>The project director; and</text> </paragraph> <paragraph num="(b)"> <text>An individual responsible for conducting the affairs of the applicant and legally authorized to execute contracts on behalf of the applicant;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A statement of the applicant's contractual obligations, assurances, and certifications on a form provided by the Commission and signed by an individual legally authorized to execute contracts on behalf of the applicant;</text> </paragraph> <paragraph num="(4)"> <text>The applicant's proposal, which includes the elements specified in Regulation .04 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Any other information or documentation the Commission may require.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Proposal Guidelines."> <text>An applicant for a grant under this subtitle shall prepare and submit to the Commission a proposal that is consistent with the instructions and requirements specified in the call for proposals, which may include:</text> <paragraph num="A."> <text>Information about the applicant, including:</text> <paragraph num="(1)"> <text>The applicant's mission, programs, and service area;</text> </paragraph> <paragraph num="(2)"> <text>The applicant's organizational strengths and challenges;</text> </paragraph> <paragraph num="(3)"> <text>The applicant's organizational structure, including:</text> <paragraph num="(a)"> <text>An indication of the applicant's for-profit or nonprofit status; and</text> </paragraph> <paragraph num="(b)"> <text>If applicable, a copy of the applicant's IRS determination letter indicating tax-exempt status under 26 U.S.C. §501(c)(3) and a statement signed by an authorized official of the organization that this ruling remains in full force and effect;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An identification of the applicant's provider type;</text> </paragraph> <paragraph num="(5)"> <text>The applicant's governance structure, including a list of the applicant's officers and governing body; and</text> </paragraph> <paragraph num="(6)"> <text>A description of the applicant's staffing pattern and a copy of its organizational chart;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A project summary;</text> </paragraph> <paragraph num="C."> <text>A project description, including a specification of the payment policies proposed by the applicant;</text> </paragraph> <paragraph num="D."> <text>A description of the target population;</text> </paragraph> <paragraph num="E."> <text>A specification of the proposed service area of the project;</text> </paragraph> <paragraph num="F."> <text>A discussion of the expected benefits of the project's success;</text> </paragraph> <paragraph num="G."> <text>An evaluation plan; and</text> </paragraph> <paragraph num="H."> <text>A work plan.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="07" heading="Selection Criteria and Funding Priorities"> <regulation prefix="Regulation" num=".01" heading="Selection Criteria."> <text>The Commission's criteria for selecting community health resources grant proposals for funding under this subtitle are as follows:</text> <paragraph num="A."> <text>Prospects for success of the proposed project, based on:</text> <paragraph num="(1)"> <text>Clear, feasible, and achievable goals and objectives;</text> </paragraph> <paragraph num="(2)"> <text>Reasonableness of work plan and budget; and</text> </paragraph> <paragraph num="(3)"> <text>Adequacy of:</text> <paragraph num="(a)"> <text>The project team's skills, competencies, commitment, and capacity to carry out the proposed work; and</text> </paragraph> <paragraph num="(b)"> <text>Organizational and community support;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Potential impact of the proposed project, based on the likelihood of the project leading to:</text> <paragraph num="(1)"> <text>Improved access to health care and health outcomes for the target population by expanding:</text> <paragraph num="(a)"> <text>Existing services to make them available to a new population not previously served by the applicant; or</text> </paragraph> <paragraph num="(b)"> <text>The types of services offered to the applicant's established population;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Expansion or replication within the community, in neighboring areas, or more broadly across the State; or</text> </paragraph> <paragraph num="(3)"> <text>Both;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Community need for the proposed project, based on the:</text> <paragraph num="(1)"> <text>Clarity and reliability of the proposal's quantitative and geographic identification and definition of the target population;</text> </paragraph> <paragraph num="(2)"> <text>Adequacy of the proposal's documentation of the target population's needs through qualitative and quantitative data such as demographics, insurance coverage rates, and service utilization statistics;</text> </paragraph> <paragraph num="(3)"> <text>Depth of the applicant's understanding of the community to be served; and</text> </paragraph> <paragraph num="(4)"> <text>Relevance of the proposed project to the community's identified needs;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Sustainability of the proposed project, based on the likelihood that the project will continue to provide benefits to the target population and the community beyond the duration of the proposed grant;</text> </paragraph> <paragraph num="E."> <text>Active engagement in the project by key participants, including relevant stakeholders, appropriate agencies and organizations, and community partners, based on their:</text> <paragraph num="(1)"> <text>Participation in the project's planning and implementation process;</text> </paragraph> <paragraph num="(2)"> <text>Allocation of dedicated staff and other resources to the project; and</text> </paragraph> <paragraph num="(3)"> <text>Contributions of facilities and equipment;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Data collection in connection with the proposed project, based on the Commission's assessment of the project team's ability to:</text> <paragraph num="(1)"> <text>Both at baseline and as the project proceeds, measure and report progress in achieving project goals and objectives through quantitative measures, such as the number, demographics, characteristics, and service utilization of the target population; and</text> </paragraph> <paragraph num="(2)"> <text>Comply with the evaluation and monitoring requirements established by the Commission;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Organizational commitment, based on the applicant's:</text> <paragraph num="(1)"> <text>Commitment to improving access to care for the target population; and</text> </paragraph> <paragraph num="(2)"> <text>Ability to demonstrate that the proposed project will significantly contribute to this goal;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Financial viability and accountability, based on the:</text> <paragraph num="(1)"> <text>Applicant's financial soundness;</text> </paragraph> <paragraph num="(2)"> <text>Adequacy of the applicant's financial management systems; and</text> </paragraph> <paragraph num="(3)"> <text>Applicant's capacity to manage grant funds; and</text> </paragraph> </paragraph> <paragraph num="I."> <text>The extent to which the applicant demonstrates use of a sliding scale fee schedule effectively to increase access to care for low-income uninsured and underinsured individuals in Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Funding Priorities."> <text>In selecting community health resources proposals to be funded under this subtitle, the Commission shall:</text> <paragraph num="A."> <text>Consider geographic balance; and</text> </paragraph> <paragraph num="B."> <text>Give priority to community health resources that:</text> <paragraph num="(1)"> <text>In addition to normal business hours, operate during evening and weekend hours;</text> </paragraph> <paragraph num="(2)"> <text>Have partnered with a hospital to establish a reverse referral program at the hospital;</text> </paragraph> <paragraph num="(3)"> <text>Reduce the use of the hospital emergency department for nonemergency services;</text> </paragraph> <paragraph num="(4)"> <text>Assist patients in establishing a medical home with a community health resource;</text> </paragraph> <paragraph num="(5)"> <text>Coordinate and integrate the delivery of primary and specialty care services;</text> </paragraph> <paragraph num="(6)"> <text>Promote the integration of mental and somatic health with federally qualified health centers or other somatic care providers;</text> </paragraph> <paragraph num="(7)"> <text>Fund medication management or therapy services for uninsured individuals:</text> <paragraph num="(a)"> <text>Whose income is up to 200 percent of the federal poverty guidelines;</text> </paragraph> <paragraph num="(b)"> <text>Who meet medical necessity criteria; and</text> </paragraph> <paragraph num="(c)"> <text>Who are ineligible for the public mental health system;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Provide a clinical home for individuals who access hospital emergency departments for mental health services, substance abuse services, or both; and</text> </paragraph> <paragraph num="(9)"> <text>Support the implementation of evidence-based clinical practices.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="08" heading="Selection Process"> <regulation prefix="Regulation" num=".01" heading="Letters of Intent — Commission Review."> <paragraph num="A."> <text>The Commission may direct staff to review letters of intent and report to:</text> <paragraph num="(1)"> <text>The Committee on Capital and Operational Funding;</text> </paragraph> <paragraph num="(2)"> <text>The Commission; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a letter of intent is submitted after the submission deadline specified in the call for proposals, the Commission shall:</text> <paragraph num="(1)"> <text>Refuse delivery of the letter of intent; or</text> </paragraph> <paragraph num="(2)"> <text>Return the letter of intent to the sender without review.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Commission shall review letters of intent properly submitted before the deadline specified in the call for proposals to:</text> <paragraph num="(1)"> <text>Ensure that identifying information submitted by an applicant is complete; and</text> </paragraph> <paragraph num="(2)"> <text>Determine the number and distribution of proposals likely to be submitted for each type of grant specified in the call for proposals.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If, pursuant to COMAR 10.45.06.02B, the call for proposals requires an applicant to submit evidence of qualification as a community health resource with the applicant's letter of intent, the Commission shall determine, consistent with the criteria set forth in COMAR 10.45.05.02, .03, and .04, whether or not the applicant qualifies as a community health resource.</text> </paragraph> <paragraph num="E."> <text>The Commission shall notify an applicant determined to be a qualified community health resource:</text> <paragraph num="(1)"> <text>Of the result of the Commission's review; and</text> </paragraph> <paragraph num="(2)"> <text>That the applicant is eligible to submit a grant application in accordance with the requirements of the call for proposals.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Except as provided in §G of this regulation, the Commission shall notify each unsuccessful applicant for qualification as a community health resource that the:</text> <paragraph num="(1)"> <text>Commission has determined that the applicant does not qualify as a community health resource; and</text> </paragraph> <paragraph num="(2)"> <text>Applicant is not eligible to submit a grant application in response to the call for proposals.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the Commission is unable to determine from its review of qualification materials submitted by the applicant whether or not the applicant qualifies as a community health resource, the Commission may:</text> <paragraph num="(1)"> <text>Request that the applicant submit additional materials supporting the application for qualification as a community health resource;</text> </paragraph> <paragraph num="(2)"> <text>Review the applicant's supplemental submission;</text> </paragraph> <paragraph num="(3)"> <text>Determine whether or not the applicant qualifies as a community health resource; and</text> </paragraph> <paragraph num="(4)"> <text>Provide notice of the Commission's decision to the applicant, in accordance with §E or F of this regulation, as appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application Review and Selection of Grantees."> <paragraph num="A."> <text>If a grant application is submitted after the submission deadline specified in the call for proposals, the Commission shall:</text> <paragraph num="(1)"> <text>Refuse delivery of the application; or</text> </paragraph> <paragraph num="(2)"> <text>Return the application to the sender without review.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Commission shall review grant applications that were properly submitted prior to the deadline specified in the call for proposals in accordance with §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>Review Procedures.</text> <paragraph num="(1)"> <text>The Commission may direct staff to:</text> <paragraph num="(a)"> <text>Initially review application materials;</text> </paragraph> <paragraph num="(b)"> <text>Conduct negotiations with successful applicants regarding program specifications and grant conditions;</text> </paragraph> <paragraph num="(c)"> <text>Report the results of staff's efforts performing the tasks assigned by the Commission pursuant to §C(1)(a) or (b) of this regulation to the:</text> <paragraph num="(i)"> <text>Commission; or</text> </paragraph> <paragraph num="(ii)"> <text>Committee on Capital and Operational Funding; or</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Perform each of the tasks identified in §C(1)(a) — (c) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Commission may consider, in connection with its evaluation of grant proposals:</text> <paragraph num="(a)"> <text>Reports by:</text> <paragraph num="(i)"> <text>The Committee on Capital and Operational Funding;</text> </paragraph> <paragraph num="(ii)"> <text>Staff; or</text> </paragraph> <paragraph num="(iii)"> <text>Both; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any application materials the Commission reviews directly.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Commission shall consider, in connection with its evaluation of grant proposals, the degree to which a proposal:</text> <paragraph num="(a)"> <text>Effectively responds to the call for proposals;</text> </paragraph> <paragraph num="(b)"> <text>Meets the selection criteria specified in COMAR 10.45.07.01; and</text> </paragraph> <paragraph num="(c)"> <text>Addresses the funding priorities specified in COMAR 10.45.07.02.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Commission determines that none of the proposals received has sufficient merit to justify award of a grant under this subtitle, the Commission shall notify all applicants of the decision not to award any grants in the present round of grant-making.</text> </paragraph> <paragraph num="(5)"> <text>If the Commission determines, consistent with the criteria and priorities set forth in COMAR 10.45.07.01 and .02, that one or more of the proposals reviewed merits a grant award, the Commission shall:</text> <paragraph num="(a)"> <text>To the extent adequate funding is available, select one or more applicant or applicants to receive funding pursuant to Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Notify all applicants with applications pending before the Commission of the Commission's decision; and</text> </paragraph> <paragraph num="(c)"> <text>With respect to applicants selected pursuant to §C(5)(a) of this regulation, include with the notice required by §C(5)(b) of this regulation:</text> <paragraph num="(i)"> <text>A specification of the amount or range of amounts the Commission expects to award to the grantee; and</text> </paragraph> <paragraph num="(ii)"> <text>An explanation of the negotiation process described in Regulation .03 of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Negotiation and Award."> <paragraph num="A."> <text>An applicant approved by the Commission for a grant award pursuant to Regulation .02 of this chapter shall, in collaboration with the Commission, develop grant specifications concerning:</text> <paragraph num="(1)"> <text>Performance milestones;</text> </paragraph> <paragraph num="(2)"> <text>Deliverables;</text> </paragraph> <paragraph num="(3)"> <text>A grant disbursement schedule;</text> </paragraph> <paragraph num="(4)"> <text>Monitoring and evaluation requirements;</text> </paragraph> <paragraph num="(5)"> <text>Data requirements; and</text> </paragraph> <paragraph num="(6)"> <text>The project's final budget.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon its approval of grant specifications proposed by the applicant pursuant to §A of this regulation, the Commission shall perfect the grant award according to the terms of the successful proposal, as modified by the specifications negotiated pursuant to §A of this regulation and agreed to by the Commission and the grantee.</text> </paragraph> <paragraph num="C."> <text>In the event the Commission and an applicant selected pursuant to Regulation .02C(5) of this chapter are unable to agree on the specifications listed in §A of this regulation, either the Commission or the applicant may withdraw.</text> </paragraph> <paragraph num="D."> <text>In the event of a withdrawal from negotiations pursuant to §C of this regulation, the Commission may, in its sole discretion, make an additional selection or selections, pursuant to Regulation .02C(5)(a) of this chapter, from applicants who submitted high-scoring proposals that were not chosen in the Commission's original selection pursuant to Regulation .02C(5)(a) of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Use of Grant Funds."> <paragraph num="A."> <text>A grantee under this subtitle may use grant funds for:</text> <paragraph num="(1)"> <text>Salaries and employment benefits for project staff;</text> </paragraph> <paragraph num="(2)"> <text>Subcontracting and consultant fees;</text> </paragraph> <paragraph num="(3)"> <text>Data collection and analysis;</text> </paragraph> <paragraph num="(4)"> <text>Project-related travel, conference calls, and meetings;</text> </paragraph> <paragraph num="(5)"> <text>Office supplies, expenses, and other indirect costs as approved by the Commission; and</text> </paragraph> <paragraph num="(6)"> <text>A limited amount of essential equipment and minor infrastructure improvements required by the project.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Funds from operating grants awarded under this subtitle may not be used for:</text> <paragraph num="(1)"> <text>The purchase or lease of major equipment;</text> </paragraph> <paragraph num="(2)"> <text>Construction projects;</text> </paragraph> <paragraph num="(3)"> <text>Support of clinical trials;</text> </paragraph> <paragraph num="(4)"> <text>Medical devices or drugs that have not received approval from the appropriate federal agency; or</text> </paragraph> <paragraph num="(5)"> <text>Lobbying or political activity.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Funds may not be used in contravention of the Department's Standard Grant Agreement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Formula for Disbursing Grants."> <paragraph num="A."> <text>The Commission shall disburse grant funds to grantees in accordance with the following formula:</text> <paragraph num="(1)"> <text>Unless the Commission finds that special circumstances apply and the grant award so specifies, the Commission shall make an initial payment to a grantee of up to 20 percent of the total grant award;</text> </paragraph> <paragraph num="(2)"> <text>The Commission shall make progress payments to a grantee in accordance with a schedule of milestones:</text> <paragraph num="(a)"> <text>To which the Commission and the grantee have agreed; and</text> </paragraph> <paragraph num="(b)"> <text>That provides that, by the time the grant period expires, the total disbursement of grant funds shall equal 100 percent of the amount awarded under this subtitle; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Unless the Commission finds that special circumstances apply and the grant award so specifies, a single progress payment may not exceed 50 percent of the total funds awarded the grantee under this subtitle.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the grantee fails to achieve any milestone, or fails to abide by the terms of the grant, the Commission may cancel the grant and withhold any or all funds not yet disbursed.</text> </paragraph> <paragraph num="C."> <text>The Commission may:</text> <paragraph num="(1)"> <text>By written agreement entered into with a grantee after the award of a grant under this subtitle, modify any milestone or schedule of milestones;</text> </paragraph> <paragraph num="(2)"> <text>Conduct audits or otherwise inspect the records, premises, and operations of the grantee to determine whether grant funds are being administered:</text> <paragraph num="(a)"> <text>In a financially responsible manner;</text> </paragraph> <paragraph num="(b)"> <text>In accordance with the terms of the grant award; and</text> </paragraph> <paragraph num="(c)"> <text>In accordance with the requirements of Regulation .04 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Establish in the grant documents such other terms and conditions relating to grant funds as the Commission considers reasonable and necessary.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .05 adopted as an emergency provision effective October 31, 2006 (33:24 Md. R. 1905); adopted permanently effective February 12, 2007 (34:3 Md. R. 299)</annotation> </annotations> </chapter> <chapter num="09" heading="Emergency Grant Funding"> <regulation prefix="Regulation" num=".01" heading="Purpose and Limitations."> <paragraph num="A."> <text>In addition to the Commission's statutory authority pursuant to Health-General Article, §19-2201(e), Annotated Code of Maryland, to award operating grants to qualifying community health resources, the Commission may award temporary emergency grants to an applicant that meets the criteria set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>Temporary emergency grants may be awarded by the Commission only if:</text> <paragraph num="(1)"> <text>The community health resource has encountered an unforeseeable lapse or cessation in otherwise stable funding that threatens an essential service or program serving low-income, uninsured, or underinsured residents within the State; and</text> </paragraph> <paragraph num="(2)"> <text>A temporary emergency grant can provide assistance sufficient to briefly sustain the service or program until stable funding is restored or alternative funding is secured.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The amount of funding available for a temporary emergency grant may not exceed $250,000.</text> </paragraph> <paragraph num="D."> <text>Temporary emergency funding obtained by a successful applicant shall make the applicant ineligible to apply for emergency funds for a 3-year period following the date of award of the temporary emergency grant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Letter of Request."> <paragraph num="A."> <text>An applicant for temporary emergency funding shall submit to the Commission a letter of request outlining the need for temporary emergency funding.</text> </paragraph> <paragraph num="B."> <text>A letter of request shall include the following elements:</text> <paragraph num="(1)"> <text>Information and documentation sufficient to establish the applicant's qualification as a community health resource as specified in COMAR 10.45.05.02, .03, or .04;</text> </paragraph> <paragraph num="(2)"> <text>A brief description of the applicant's mission, programs, and service area;</text> </paragraph> <paragraph num="(3)"> <text>The name, address, and location of the applicant, including the:</text> <paragraph num="(a)"> <text>Name, title, address, telephone number, and email address of the director; and</text> </paragraph> <paragraph num="(b)"> <text>Name and email address of the applicant's contact person;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The signature of an individual responsible for conducting the affairs of the applicant and legally authorized to execute contracts on the applicant's behalf;</text> </paragraph> <paragraph num="(5)"> <text>A brief account of the organizational and financial structure of the applicant, including the applicant's:</text> <paragraph num="(a)"> <text>For-profit or not-for-profit status; and</text> </paragraph> <paragraph num="(b)"> <text>Financial stability over the 3-year period prior to the date of application; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The nature of the program or service whose existence or funding is threatened, including:</text> <paragraph num="(a)"> <text>The significance of the program or service to its target group and to the geographic area in which it operates;</text> </paragraph> <paragraph num="(b)"> <text>The customary and usual amount of funds needed to provide the service or operate the program on a monthly, quarterly, or annual basis;</text> </paragraph> <paragraph num="(c)"> <text>The normal or usual funding source or sources for the program or service;</text> </paragraph> <paragraph num="(d)"> <text>The number and area of residence of low income, underinsured, or uninsured persons served by the program or service on a monthly, quarterly, or annual basis;</text> </paragraph> <paragraph num="(e)"> <text>A concise explanation of why the temporary emergency for which funding is sought could not have been anticipated;</text> </paragraph> <paragraph num="(f)"> <text>A concise account of any and all emergency funding requests by the applicant over the past 3 years and the results of those requests;</text> </paragraph> <paragraph num="(g)"> <text>The specific amount of funding requested and the amount of time over which the funding will be expended;</text> </paragraph> <paragraph num="(h)"> <text>A list of all other potential sources of funding, both internal and external, that have been approached by the applicant for this temporary emergency and their responses;</text> </paragraph> <paragraph num="(i)"> <text>A clear explanation of how the requested funds will enable the applicant to stabilize the threatened service or program; and</text> </paragraph> <paragraph num="(j)"> <text>Any other information that the Commission may require on the emergency grant application form.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Selection Process."> <paragraph num="A."> <text>Letters of Request — Commission Review. The Commission may direct staff to review a letter of request and report to:</text> <paragraph num="(1)"> <text>The Committee on Capital and Operational Funding (Committee);</text> </paragraph> <paragraph num="(2)"> <text>The Commission; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Temporary emergency funding requests shall be reviewed on a timely basis as follows:</text> <paragraph num="(1)"> <text>Temporary emergency funding requests submitted from the 1st through 15th of any month shall be preliminarily reviewed by staff prior to the end of the month and forwarded to the Commission, the Committee, or both, within 10 days; or</text> </paragraph> <paragraph num="(2)"> <text>Temporary emergency funding requests submitted from the 16th through the last day of the month shall be preliminarily reviewed by staff prior to the 15th of the succeeding month and forwarded to the Commission, the Committee, or both, within 10 days.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staff Determinations.</text> <paragraph num="(1)"> <text>Staff shall review a request for emergency funding to preliminarily ascertain that:</text> <paragraph num="(a)"> <text>Sufficient information has been provided to determine a community health resource's status; and</text> </paragraph> <paragraph num="(b)"> <text>Sufficient information has been provided concerning the threatened service or program for which funding is being requested.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Staff shall alert the applicant to perceived preliminary deficiencies, if any, in the submission and request supplementation as necessary.</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the information required as preliminarily determined by staff, the letter of request shall be forwarded to the Committee, the Commission, or both, at the discretion of the Commission chairperson.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Selection Criteria for Temporary Emergency Funding."> <text>The Commission's criteria for awarding an emergency grant to a community health resource are as follows:</text> <paragraph num="A."> <text>The nature of the temporary emergency situation, including an evaluation of the applicant's inability to anticipate the emergency situation;</text> </paragraph> <paragraph num="B."> <text>The essential nature of the threatened program or service to the population served and as part of the provision of essential health care services to the relevant low-income population;</text> </paragraph> <paragraph num="C."> <text>The reasonable likelihood of resolution of the temporary emergency situation as a direct result of the requested emergency funds;</text> </paragraph> <paragraph num="D."> <text>The reasonable likelihood of the sustainability of the threatened program or service upon the cessation of temporary emergency funding; and</text> </paragraph> <paragraph num="E."> <text>The number of emergencies, as that term is described in Regulation .01B of this chapter, for which funding was sought by the applicant in the last 3 years, and the number of instances in which funding was obtained.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Review by Committee on Capital and Operational Funding."> <paragraph num="A."> <text>The Committee on Capital and Operational Funding shall review letters of request in a timely manner to:</text> <paragraph num="(1)"> <text>Ensure that all information as to community health resource status specified in COMAR 10.45.05 has been provided and, if not, request that specific supplements be provided; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that all information required in the letter of request under Regulation .02B of this chapter has been provided and, if not, request that specific supplements be provided.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Following receipt of all necessary information, the Committee shall:</text> <paragraph num="(1)"> <text>Make an initial determination as to whether the applicant qualifies as a community health resource pursuant to the criteria specified in COMAR 10.45.05;</text> </paragraph> <paragraph num="(2)"> <text>Make an initial determination as to whether temporary emergency funds should be provided to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Make an initial determination as to the amount of temporary emergency funds to be awarded to the applicant; and</text> </paragraph> <paragraph num="(4)"> <text>Forward to the Commission for review:</text> <paragraph num="(a)"> <text>The Committee's recommendation on each of the determinations required by §B(1) — (3) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The community health resource's letter of request; and</text> </paragraph> <paragraph num="(c)"> <text>Any supplementary documents.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Review by the Commission."> <paragraph num="A."> <text>Upon receipt of a recommendation on a request for emergency funding from the Committee on Capital and Operational Funding, or on its own initiative, the Commission shall:</text> <paragraph num="(1)"> <text>Determine whether all necessary information has been made available and, if not, request supplementary information; and</text> </paragraph> <paragraph num="(2)"> <text>Determine whether the applicant qualifies as a community health resource pursuant to COMAR 10.45.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Commission determines that the applicant is not a community health resource, the Commission shall notify the applicant that the applicant is not eligible to receive emergency funding from the Commission.</text> </paragraph> <paragraph num="C."> <text>If the Commission determines that the applicant is a community health resource, the Commission shall consider whether the applicant:</text> <paragraph num="(1)"> <text>Has provided information documenting an unforeseeable temporary emergency situation threatening an essential service or program; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the selection criteria specified in Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Commission determines, consistent with the criteria set forth in §A of this regulation, that the applicant's request does not meet the criteria for award of a temporary emergency grant under this subtitle, the Commission shall notify the applicant of the Commission's decision not to make temporary emergency funds available.</text> </paragraph> <paragraph num="E."> <text>If the Commission determines, consistent with the criteria set forth in §A of this regulation, that the applicant's request should receive funding, the Commission shall:</text> <paragraph num="(1)"> <text>To the extent adequate funding is available, determine the:</text> <paragraph num="(a)"> <text>Amount of emergency funds that will be offered to the applicant; and</text> </paragraph> <paragraph num="(b)"> <text>Conditions under which funds will be made available;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Direct staff to conduct negotiations with the applicant regarding the specified grant conditions; and</text> </paragraph> <paragraph num="(3)"> <text>Notify the successful applicant of the fact that temporary emergency funds will be made available conditioned on the applicant's acceptance of the terms of the emergency grant agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Negotiation and Award."> <paragraph num="A."> <text>An applicant approved by the Commission for a temporary emergency grant pursuant to Regulation .06 of this chapter shall, in collaboration with the Commission, develop grant specifications concerning:</text> <paragraph num="(1)"> <text>A grant disbursement schedule;</text> </paragraph> <paragraph num="(2)"> <text>Monitoring and evaluation requirements;</text> </paragraph> <paragraph num="(3)"> <text>Data requirements; and</text> </paragraph> <paragraph num="(4)"> <text>The budget that will be impacted by the emergency grant funds.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon the Commission's approval of grant specifications proposed by the applicant pursuant to §A of this regulation, the Commission shall perfect the temporary emergency grant award according to the terms of the successful letter of request, as modified by the specifications negotiated pursuant to §A of this regulation and agreed to by the Commission and the grantee.</text> </paragraph> <paragraph num="C."> <text>In the event the Commission and an applicant are unable to agree on the specifications listed in §A of this regulation, either the Commission or the applicant may withdraw.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Use of Grant Funds."> <paragraph num="A."> <text>A grantee under this chapter may use grant funds only for the purposes outlined in the applicant's letter of request unless a change in those conditions has been previously agreed to by the Commission and the applicant in writing.</text> </paragraph> <paragraph num="B."> <text>If a grantee fails to abide by the terms of a grant agreement, the Commission may cancel the grant and withhold any or all funds not yet disbursed.</text> </paragraph> <paragraph num="C."> <text>The Commission may:</text> <paragraph num="(1)"> <text>By written agreement entered into with an emergency grantee after the award of an emergency grant under this subtitle, modify the terms of the grant agreement; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct audits or otherwise inspect the records, premises, and operations of the grantee to determine whether grant funds are being administered:</text> <paragraph num="(a)"> <text>In a financially responsible manner; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with the terms of the grant award.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The successful grantee, based on being awarded an emergency grant from the Commission, shall sign an agreement not to seek emergency funding from the Commission for a period of 3 years following the date of notification of the grant award.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§19-2107, 19-2109, and 19-2201, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 — .08 adopted as an emergency provision effective June 1, 2007 (34:13 Md. R. 1149); adopted permanently effective November 5, 2007 (34:22 Md. R. 1977)</annotation> </annotations> </chapter> </subtitle> <subtitle num="46" heading="Board of Occupational Therapy Practice"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Aide” means any individual who is not licensed by the Board to perform occupational therapy or limited occupational therapy and who provides supportive services to the occupational therapist or occupational therapy assistant under direct supervision.</text> </paragraph> <paragraph num="(2)"> <text>“AOTA” means the American Occupational Therapy Association, formerly the American Occupational Therapy Certification Board (AOTCB).</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the State Board of Occupational Therapy Practice.</text> </paragraph> <paragraph num="(4)"> <text>“Case resolution conference (CRC)” means a voluntary, informal, and confidential proceeding to explore the possibility of a consent order resolution of a disciplinary matter.</text> </paragraph> <paragraph num="(5)"> <text>“Client” means a consumer, patient, or recipient of occupational therapy services.</text> </paragraph> <paragraph num="(6)"> <text>“Competence” means an individual's capacity for performance in occupational therapy principles and procedures.</text> </paragraph> <paragraph num="(7)"> <text>Competency.</text> <paragraph num="(a)"> <text>“Competency” means the demonstration of the pertinent knowledge of and performance skills in occupational therapy principles and procedures within the practice of occupational therapy and limited occupational therapy.</text> </paragraph> <paragraph num="(b)"> <text>“Competency” includes satisfactory completion of educational programs or experiences, specialty certification, continuing education, or all of these.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Direct supervision” means supervision provided on a face-to-face basis by a supervisor who is a licensed occupational therapist or occupational therapy assistant, during the performance of delegated client-related tasks.</text> </paragraph> <paragraph num="(9)"> <text>“Elective nonrenewal” means choosing to render one's license inactive.</text> </paragraph> <paragraph num="(10)"> <text>“Evaluation” means the ongoing process of:</text> <paragraph num="(a)"> <text>Data collection by a licensed occupational therapist or an occupational therapy assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Interpretation of the data by a licensed occupational therapist for purposes including, but not limited to:</text> <paragraph num="(i)"> <text>The need for treatment; and</text> </paragraph> <paragraph num="(ii)"> <text>Plans for discharge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Expired license” means an individual’s authority to practice occupational therapy or limited occupational therapy which has not been renewed through the process of renewal or elective nonrenewal and is invalid.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed” means formally authorized by the Board to practice occupational therapy or limited occupational therapy.</text> </paragraph> <paragraph num="(13)"> <text>“Licensee” means an individual who is a licensed occupational therapist or a licensed occupational therapy assistant.</text> </paragraph> <paragraph num="(14)"> <text>Limited Occupational Therapy.</text> <paragraph num="(a)"> <text>“Limited occupational therapy” means the therapeutic use of purposeful and meaningful goal-directed activities in collaboration with an occupational therapy assistant and an occupational therapist during the treatment of individuals that:</text> <paragraph num="(i)"> <text>Have a disease or disorder, impairment, activity limitation, or participation restriction that interferes with their ability to function independently in daily life roles; or</text> </paragraph> <paragraph num="(ii)"> <text>Benefit from the prevention of impairments and activity limitations.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Limited occupational therapy” means that the collaboration of the occupational therapy assistant occurs under the periodic supervision of a licensed occupational therapist.</text> </paragraph> <paragraph num="(c)"> <text>“Limited occupational therapy” means that the occupational therapy assistant is authorized to:</text> <paragraph num="(i)"> <text>Conduct an initial screening;</text> </paragraph> <paragraph num="(ii)"> <text>Collect data for an evaluation that applies the principles and procedures of occupational therapy; and</text> </paragraph> <paragraph num="(iii)"> <text>Participate in a treatment program that applies the principles and procedures of occupational therapy.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>“Limited occupational therapy” does not include:</text> <paragraph num="(i)"> <text>Initiation or interpretation of evaluation data; and</text> </paragraph> <paragraph num="(ii)"> <text>Initiation of a treatment program before the client has been evaluated and a licensed occupational therapist has rendered a treatment plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“NBCOT” means the National Board for Certification in Occupational Therapy, formerly the American Occupational Therapy Certification Board (AOTCB).</text> </paragraph> <paragraph num="(16)"> <text>“Occupational therapist” means, unless the context requires otherwise, an occupational therapist that is licensed by the Board to practice occupational therapy.</text> </paragraph> <paragraph num="(17)"> <text>“Occupational therapy” means the therapeutic use of purposeful and meaningful goal-directed activities to evaluate, consult, and treat individuals that:</text> <paragraph num="(a)"> <text>Have a disease or disorder, impairment, activity limitation, or participation restriction that interferes with their ability to function independently in daily life roles; or</text> </paragraph> <paragraph num="(b)"> <text>Benefit from the prevention of impairments and activity limitations.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Occupational therapy assistant” means, unless the context requires otherwise, an occupational therapy assistant who is licensed by the Board to practice limited occupational therapy.</text> </paragraph> <paragraph num="(19)"> <text>“On-site supervision” means supervision provided by a supervisor who is:</text> <paragraph num="(a)"> <text>A licensed occupational therapist or occupational therapy assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Immediately available on the premises to provide direct supervision, if needed, when client-related procedures are performed or as otherwise necessary.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Periodic Supervision.</text> <paragraph num="(a)"> <text>“Periodic supervision” means supervision provided by a supervisor who is a licensed occupational therapist on a face-to-face basis, for each client who is being treated by the licensed occupational therapy assistant supervisee, occurring the earlier of at least:</text> <paragraph num="(i)"> <text>Once every 10 therapy visits; or</text> </paragraph> <paragraph num="(ii)"> <text>Once every 30 calendar days.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Periodic supervision” includes:</text> <paragraph num="(i)"> <text>Chart review; and</text> </paragraph> <paragraph num="(ii)"> <text>Meetings to discuss client treatment plans, client response to treatment, or observation of treatment, as indicated to ensure the competent and safe provision of occupational therapy services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Reevaluation” means:</text> <paragraph num="(a)"> <text>The data collection by a licensed occupational therapist or an occupational therapy assistant; and</text> </paragraph> <paragraph num="(b)"> <text>Interpretation of the reevaluation data by a licensed occupational therapist after the initial evaluation, for the purpose of determining:</text> <paragraph num="(i)"> <text>A client's response to treatment;</text> </paragraph> <paragraph num="(ii)"> <text>Changes in the client's status;</text> </paragraph> <paragraph num="(iii)"> <text>The need for treatment modification; and</text> </paragraph> <paragraph num="(iv)"> <text>Plans for discharge.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Reactivation” means revalidating a license previously rendered invalid by the process of elective nonrenewal.</text> </paragraph> <paragraph num="(23)"> <text>“Reinstatement” means revalidating a license previously rendered invalid.</text> </paragraph> <paragraph num="(24)"> <text>“Renewal” means validating an active license for an additional term.</text> </paragraph> <paragraph num="(25)"> <text>Screening.</text> <paragraph num="(a)"> <text>“Screening” means a cursory determination by an occupational therapist or occupational therapy assistant of the need for more comprehensive evaluation and treatment.</text> </paragraph> <paragraph num="(b)"> <text>“Screening” does not mean a substitute for the evaluation.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Supervision” means the provision of clinical aid, direction, and instruction, by either a licensed occupational therapist or an occupational therapy assistant, to ensure the competent delivery of occupational therapy services.</text> </paragraph> <paragraph num="(27)"> <text>“Supervisor” means an occupational therapist or occupational therapy assistant, excluding temporary licensees, who is licensed by the Board and has the responsibility of clinically supervising the provision of occupational therapy treatment services.</text> </paragraph> <paragraph num="(28)"> <text>“Temporary occupational therapy assistant licensee” means an individual licensed by the Board on a temporary basis, who:</text> <paragraph num="(a)"> <text>Except for completing the required certification examination, has met all other licensure requirements of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed to practice under the on-site supervision of a licensed occupational therapist or occupational therapy assistant.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Temporary occupational therapist licensee” means an individual licensed by the Board on a temporary basis, who:</text> <paragraph num="(a)"> <text>Except for completing the required certification examination, has met all other licensure requirements of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is licensed to practice under the on-site supervision of a licensed occupational therapist.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Treatment program” means a therapeutic intervention plan designed by a licensed occupational therapist that outlines the selected approaches and types of intervention to be used to enable the client to reach identified targeted outcomes or treatment goals.</text> </paragraph> <paragraph num="(31)"> <text>“Verification” means proof of licensure, certification, registration, or continuing education:</text> <paragraph num="(a)"> <text>Confirmable by the Board based on documentation provided by the applicant;</text> </paragraph> <paragraph num="(b)"> <text>Obtained from a verification service provider approved by the issuing entity and accepted by the Board at its discretion; or</text> </paragraph> <paragraph num="(c)"> <text>Obtained from the entity by which the applicant is licensed, certified, registered, or educated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Licensure."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, an individual shall be licensed by the Board before the individual may practice occupational therapy or limited occupational therapy.</text> </paragraph> <paragraph num="B."> <text>Term and Renewal of License.</text> <paragraph num="(1)"> <text>An initial license is issued after successfully completing the application process and is valid for 2-1/2 years or less.</text> </paragraph> <paragraph num="(2)"> <text>At least 30 days before the expiration date of the license, the Board shall send a notice of renewal by electronic means or first-class mail to the last known electronic or physical address of each active licensee, and each licensee who is inactive by elective nonrenewal, who is eligible for renewal.</text> </paragraph> <paragraph num="(3)"> <text>In order to renew a license, the licensee shall submit to the Board a completed renewal application by the deadline for renewal.</text> </paragraph> <paragraph num="(4)"> <text>The licensee shall submit an electronic payment, money order, or check in the amount of the renewal fee established by the Board in COMAR 10.46.05.01.</text> </paragraph> <paragraph num="(5)"> <text>Incomplete applications will not be accepted.</text> </paragraph> <paragraph num="(6)"> <text>If a completed renewal application is submitted after the deadline but before the expiration, the Board shall assess a late fee as specified in COMAR 10.46.05.01.</text> </paragraph> <paragraph num="(7)"> <text>A completed renewal application received with an on-line licensure confirmation or postmark dated after the expiration date of June 30 will not be accepted.</text> </paragraph> <paragraph num="(8)"> <text>At the time of licensure renewal, a licensee who has completed the continuing competency requirement shall attest to the:</text> <paragraph num="(a)"> <text>Maintenance of Current Certification with the National Board of Certification in Occupational Therapy (NBCOT); or</text> </paragraph> <paragraph num="(b)"> <text>Completion of continuing competency activities, as specified in COMAR 10.46.04.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>At the time of licensure renewal, a licensee shall indicate a desire to:</text> <paragraph num="(a)"> <text>Carry over contact hours from one continuing competency time frame to another; or</text> </paragraph> <paragraph num="(b)"> <text>Utilize contact hours carried over from the previous renewal period.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A licensee who is audited regarding continuing competency requirements, as specified in COMAR 10.46.04:</text> <paragraph num="(a)"> <text>Shall successfully complete the requirements of the audit; or</text> </paragraph> <paragraph num="(b)"> <text>May be subject to disciplinary action by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Time Frames for Application Materials. The applicant shall submit all materials required by the Board in accordance with this regulation within a specified time frame from the date the application was initiated until the date the application is completed as follows:</text> <paragraph num="(1)"> <text>Licensure documentation not to exceed 6 months;</text> </paragraph> <paragraph num="(2)"> <text>Temporary licensure documentation, with no changes in data originally submitted, not to exceed 6 months; and</text> </paragraph> <paragraph num="(3)"> <text>Second temporary licensure documentation, with no changes in data originally submitted, not to exceed 6 months.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>An application is not complete until all required material, including the required fee and supporting documentation, is received by the Board;</text> </paragraph> <paragraph num="(2)"> <text>If an applicant for licensure, reinstatement, or reactivation fails to provide the required documentation within 6 months of receipt of the initial receipt, the Board may administratively close the application.</text> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is administratively closed may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 10, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Application Procedures for Licensure. To apply for a license, an applicant shall submit the following documentation to the Board:</text> <paragraph num="(1)"> <text>An application completed in accordance with the directions provided;</text> </paragraph> <paragraph num="(2)"> <text>Verification of:</text> <paragraph num="(a)"> <text>Initial certification or examination from the NBCOT; or</text> </paragraph> <paragraph num="(b)"> <text>Examination score from the testing agency within 60 days of examination;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Proof of fingerprinting for completion of a criminal history records check;</text> </paragraph> <paragraph num="(4)"> <text>An approved form of payment in the amount of the application fee established by the Board in COMAR 10.46.05.01;</text> </paragraph> <paragraph num="(5)"> <text>If currently, or previously, authorized to practice in any other state or country, or both, verification of:</text> <paragraph num="(a)"> <text>Licensure;</text> </paragraph> <paragraph num="(b)"> <text>Registration; or</text> </paragraph> <paragraph num="(c)"> <text>Certification;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Verification of successful completion of the Maryland Board of Occupational Therapy Jurisprudence Examination;</text> </paragraph> <paragraph num="(7)"> <text>Documentation certifying:</text> <paragraph num="(a)"> <text>Maintenance of Current Certification with the National Board of Certification in Occupational Therapy (NBCOT); or</text> </paragraph> <paragraph num="(b)"> <text>Completion of continuing competency activities, as specified in COMAR 10.46.04; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Additional requirements as specified in COMAR 10.46.04 for applicants with 3 or more years lapse in practice.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Application Procedures for Temporary Licensure.</text> <paragraph num="(1)"> <text>A temporary license may be issued to an applicant who, except for completing the required certification examination, has met all other licensure requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>To apply for a temporary license, an applicant shall submit the following documentation to the Board:</text> <paragraph num="(a)"> <text>An application completed in accordance with the directions provided;</text> </paragraph> <paragraph num="(b)"> <text>Verification confirming the applicant’s eligibility and registration to take the certification examination within the eligibility activation period;</text> </paragraph> <paragraph num="(c)"> <text>Proof of fingerprinting completed for a criminal history records check;</text> </paragraph> <paragraph num="(d)"> <text>An approved form of payment in the amount of the application fee established by the Board in COMAR 10.46.05.01;</text> </paragraph> <paragraph num="(e)"> <text>If currently, or previously, authorized to practice in any other state or country, or both, verification of:</text> <paragraph num="(i)"> <text>Licensure;</text> </paragraph> <paragraph num="(ii)"> <text>Registration; or</text> </paragraph> <paragraph num="(iii)"> <text>Certification;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Verification of the successful completion of the Maryland Board of Occupational Therapy Jurisprudence Examination; and</text> </paragraph> <paragraph num="(g)"> <text>Documentation certifying completion of continuing competency activities, as specified in COMAR 10.46.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Application Procedures for a Second Temporary License.</text> <paragraph num="(1)"> <text>A second temporary license may be issued to an applicant:</text> <paragraph num="(a)"> <text>Whose initial temporary license expired; and</text> </paragraph> <paragraph num="(b)"> <text>Who, except for completing the required certification examination, has met all other licensure requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To apply for a second temporary license, an applicant shall submit the following documentation to the Board:</text> <paragraph num="(a)"> <text>Verification confirming the applicant’s eligibility and registration to take the certification examination within the eligibility activation period;</text> </paragraph> <paragraph num="(b)"> <text>An approved form of payment in the amount of the temporary license fee established by the Board in COMAR 10.46.05.01; and</text> </paragraph> <paragraph num="(c)"> <text>Updated versions of any application documents previously submitted which have expired.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Application Procedures for Nonrenewal of License.</text> <paragraph num="(1)"> <text>Elective Nonrenewal.</text> <paragraph num="(a)"> <text>A licensee wishing to render a license inactive for a specified renewal term may electively nonrenew the license for that term.</text> </paragraph> <paragraph num="(b)"> <text>For each specific renewal term for which inactive status is requested, the licensee shall apply for elective nonrenewal.</text> </paragraph> <paragraph num="(c)"> <text>The Board shall send a notice of renewal by electronic means or first-class mail to the last known electronic or physical address of each inactive licensee who is eligible for renewal or elective nonrenewal.</text> </paragraph> <paragraph num="(d)"> <text>In order to electively nonrenew a license, the licensee shall submit to the Board a completed application, by the expiration date of June 30.</text> </paragraph> <paragraph num="(e)"> <text>A completed application for elective nonrenewal received with an online application confirmation or postmark dated after the expiration date will not be accepted.</text> </paragraph> <paragraph num="(f)"> <text>The licensee shall submit a money order, check, or electronic payment in the amount of the elective nonrenewal fee established by the Board in COMAR 10.46.05.01.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Expiration. A license that has not been renewed through the process of renewal or elective nonrenewal is expired and invalid.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Application Procedures for Reactivation or Reinstatement of License.</text> <paragraph num="(1)"> <text>To apply for reactivation after elective nonrenewal or reinstatement after expiration, an applicant shall submit the following documentation to the Board within the timeframe specified on the application:</text> <paragraph num="(a)"> <text>An application completed in accordance with the directions provided;</text> </paragraph> <paragraph num="(b)"> <text>Verification of initial certification or examination from the NBCOT;</text> </paragraph> <paragraph num="(c)"> <text>Proof of fingerprinting completed for a criminal history records check;</text> </paragraph> <paragraph num="(d)"> <text>An approved form of payment in the amount of the applicable fee established by the Board in COMAR 10.46.05.01;</text> </paragraph> <paragraph num="(e)"> <text>If currently, or previously, authorized to practice in any other state or country, or both, verification of:</text> <paragraph num="(i)"> <text>Licensure;</text> </paragraph> <paragraph num="(ii)"> <text>Registration; or</text> </paragraph> <paragraph num="(iii)"> <text>Certification;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Verification of successful completion of the Maryland Board of Occupational Therapy Jurisprudence Examination; and</text> </paragraph> <paragraph num="(g)"> <text>Documentation certifying:</text> <paragraph num="(i)"> <text>Maintenance of current certification with the National Board of Certification in Occupational Therapy (NBCOT); or</text> </paragraph> <paragraph num="(ii)"> <text>Completion of continuing competency activities as specified in COMAR 10.46.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Additional requirements may apply for applicants with 3 or more years lapse in practice as specified in COMAR 10.46.04.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Address Change.</text> <paragraph num="(1)"> <text>An applicant or licensee shall report a change of electronic mail address or postal address, in writing, within 30 days of the change.</text> </paragraph> <paragraph num="(2)"> <text>Failure to comply may result in assessment of a fee as specified in COMAR 10.46.05.01.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Name Change.</text> <paragraph num="(1)"> <text>An applicant or licensee shall report a change of name, in writing, within 30 days of the change;</text> </paragraph> <paragraph num="(2)"> <text>The report of a change in name shall include documentation substantiating the name change.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Verification of Maryland License.</text> <paragraph num="(1)"> <text>Electronic Verification. An individual may independently obtain information on the licensure status of licensees in the following ways:</text> <paragraph num="(a)"> <text>Upon accessing the Board’s website, an individual may view and print a licensee’s status;</text> </paragraph> <paragraph num="(b)"> <text>Upon accessing the Board’s mobile software application, an individual may view a licensee’s status; or</text> </paragraph> <paragraph num="(c)"> <text>Upon phoning the Board office, an individual may receive verbal verification of a licensee’s status.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Board-Provided Verification.</text> <paragraph num="(a)"> <text>Upon request, the Board shall provide written documentation certifying licensure status and disciplinary history in Maryland.</text> </paragraph> <paragraph num="(b)"> <text>The request for Board verification shall include:</text> <paragraph num="(i)"> <text>The name of the licensee to be verified;</text> </paragraph> <paragraph num="(ii)"> <text>The address where the completed verification is to be forwarded; and</text> </paragraph> <paragraph num="(iii)"> <text>An approved form of payment in the amount of the verification of licensure fee established by the Board in COMAR 10.46.05.01.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Practice."> <paragraph num="A."> <text>Occupational Therapist.</text> <paragraph num="(1)"> <text>An occupational therapist shall exercise sound judgment and provide adequate care in the performance of duties as provided in nationally recognized standards of practice.</text> </paragraph> <paragraph num="(2)"> <text>An occupational therapist shall document client information as follows:</text> <paragraph num="(a)"> <text>Evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Treatment program;</text> </paragraph> <paragraph num="(c)"> <text>Progress reports;</text> </paragraph> <paragraph num="(d)"> <text>Reevaluations; and</text> </paragraph> <paragraph num="(e)"> <text>Discharge summaries, verbal orders, and clarification orders in accordance with facility policies and procedures.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An occupational therapist shall immediately discontinue any treatment procedure that appears harmful to the client.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Occupational Therapy Assistant.</text> <paragraph num="(1)"> <text>An occupational therapy assistant shall exercise sound judgment and provide adequate care in the performance of duties as provided in nationally recognized standards of practice.</text> </paragraph> <paragraph num="(2)"> <text>An occupational therapy assistant shall document client information as follows:</text> <paragraph num="(a)"> <text>Progress reports;</text> </paragraph> <paragraph num="(b)"> <text>Reevaluations; and</text> </paragraph> <paragraph num="(c)"> <text>Discharge summaries, verbal orders, and clarification orders in accordance with facility policies and procedures.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An occupational therapy assistant may begin a treatment program after the occupational therapist has:</text> <paragraph num="(a)"> <text>Evaluated the client;</text> </paragraph> <paragraph num="(b)"> <text>Established an initial treatment program; and</text> </paragraph> <paragraph num="(c)"> <text>Engaged in verbal, written, or electronic communication with the occupational therapy assistant.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An occupational therapy assistant may not analyze or interpret evaluation data.</text> </paragraph> <paragraph num="(5)"> <text>An occupational therapy assistant may assist and participate in the screening, evaluation, reevaluation, and discharge planning process by:</text> <paragraph num="(a)"> <text>Collecting data, such as records;</text> </paragraph> <paragraph num="(b)"> <text>General observation;</text> </paragraph> <paragraph num="(c)"> <text>Conducting a general interview;</text> </paragraph> <paragraph num="(d)"> <text>Using assessment tools; or</text> </paragraph> <paragraph num="(e)"> <text>All of §B(5)(a)—(d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An occupational therapy assistant shall communicate to the occupational therapist verbally, in writing, or electronically, the information gathered.</text> </paragraph> <paragraph num="(7)"> <text>An occupational therapy assistant shall track and report changes in the client's status that might warrant the need for reevaluation.</text> </paragraph> <paragraph num="(8)"> <text>An occupational therapy assistant shall immediately discontinue any treatment procedure that appears harmful to the client and shall notify the supervising occupational therapist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Supervision Requirements."> <paragraph num="A."> <text>Occupational Therapist.</text> <paragraph num="(1)"> <text>A licensed occupational therapist may supervise the clinical practice of the following:</text> <paragraph num="(a)"> <text>Occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>Occupational therapy assistant;</text> </paragraph> <paragraph num="(c)"> <text>Temporary occupational therapist;</text> </paragraph> <paragraph num="(d)"> <text>Temporary occupational therapy assistant;</text> </paragraph> <paragraph num="(e)"> <text>Aide; and</text> </paragraph> <paragraph num="(f)"> <text>Occupational therapy student or occupational therapy assistant student.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless otherwise stated, a supervisor need not be physically present on the premises at all times, but may be available by telephone or by other electronic communication means.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Occupational Therapy Assistant.</text> <paragraph num="(1)"> <text>Subject to the requirements of this section, an occupational therapy assistant may practice limited occupational therapy under the supervision of an occupational therapist provided it is at least periodic supervision.</text> </paragraph> <paragraph num="(2)"> <text>The supervising occupational therapist working with the occupational therapy assistant shall determine the appropriate amount and type of supervision necessary, taking into consideration:</text> <paragraph num="(a)"> <text>Skills, experience, and education of the occupational therapy assistant and the occupational therapist;</text> </paragraph> <paragraph num="(b)"> <text>Change in a client's status;</text> </paragraph> <paragraph num="(c)"> <text>Complexity of the treatment program; and</text> </paragraph> <paragraph num="(d)"> <text>Type and requirements of practice setting.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to the other requirements specified by this section, supervision requires that, before the initiation of the treatment program and before a planned discharge, the supervising occupational therapist shall provide direction to the occupational therapy assistant by verbal, written, or electronic communication.</text> </paragraph> <paragraph num="(4)"> <text>An occupational therapy assistant, under the direction of the occupational therapist, is permitted to be the primary clinical supervisor for the following:</text> <paragraph num="(a)"> <text>Aide;</text> </paragraph> <paragraph num="(b)"> <text>Temporary occupational therapy assistant;</text> </paragraph> <paragraph num="(c)"> <text>Level I fieldwork occupational therapy student; and</text> </paragraph> <paragraph num="(d)"> <text>Level I and Level II fieldwork occupational therapy assistant student.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The occupational therapy assistant may be utilized to facilitate occupational therapy student and occupational therapy assistant student learning experiences in both Level I and Level II fieldwork under the direction of the occupational therapist.</text> </paragraph> <paragraph num="(6)"> <text>The supervising occupational therapist and the occupational therapy assistant are jointly responsible for maintaining formal documentation of periodic supervision as set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Temporary License to Practice Occupational Therapy.</text> <paragraph num="(1)"> <text>A temporary license to practice occupational therapy authorizes the licensee to practice occupational therapy with on-site supervision.</text> </paragraph> <paragraph num="(2)"> <text>The supervising occupational therapist and the temporary occupational therapist are jointly responsible for maintaining documentation of supervision as set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Temporary License to Practice Limited Occupational Therapy.</text> <paragraph num="(1)"> <text>A temporary license to practice limited occupational therapy authorizes the licensee to practice limited occupational therapy with on-site supervision.</text> </paragraph> <paragraph num="(2)"> <text>The supervising occupational therapist or the supervising occupational therapy assistant and the temporary occupational therapy assistant are jointly responsible for maintaining documentation of supervision as set forth in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Aide.</text> <paragraph num="(1)"> <text>A supervising occupational therapist or occupational therapy assistant working with an aide shall provide direct supervision to the aide when the aide is performing tasks within the occupational therapy treatment program.</text> </paragraph> <paragraph num="(2)"> <text>The supervising occupational therapist or occupational therapy assistant shall assign to an aide only those tasks that do not require education or training in occupational therapy and that the aide can perform competently.</text> </paragraph> <paragraph num="(3)"> <text>The supervising occupational therapist or occupational therapy assistant is responsible for ensuring that the aide delivers service in a safe and competent manner.</text> </paragraph> <paragraph num="(4)"> <text>Prescribed tasks within the treatment program that may be performed by an aide under the direct supervision of an occupational therapist include, but are not limited to:</text> <paragraph num="(a)"> <text>Guarding;</text> </paragraph> <paragraph num="(b)"> <text>Positioning;</text> </paragraph> <paragraph num="(c)"> <text>Holding body parts for splinting or bracing; and</text> </paragraph> <paragraph num="(d)"> <text>Assisting with group and community reentry activities.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Prescribed tasks within the treatment program that may be performed by an aide under the direct supervision of an occupational therapist or occupational therapy assistant include:</text> <paragraph num="(a)"> <text>Transfer practice;</text> </paragraph> <paragraph num="(b)"> <text>Assisting in routine:</text> <paragraph num="(i)"> <text>Functional activity;</text> </paragraph> <paragraph num="(ii)"> <text>Functional exercise; and</text> </paragraph> <paragraph num="(iii)"> <text>Activities of daily living (ADL) program;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Applying assistive devices;</text> </paragraph> <paragraph num="(d)"> <text>Applying adaptive devices;</text> </paragraph> <paragraph num="(e)"> <text>Assisting the client with the use of assistive equipment;</text> </paragraph> <paragraph num="(f)"> <text>Assisting the client with the use of adaptive equipment; and</text> </paragraph> <paragraph num="(g)"> <text>Reality orientation for the confused client.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Nontreatment activities that may be performed by an aide under the direction of an occupational therapist or occupational therapy assistant include:</text> <paragraph num="(a)"> <text>Clerical;</text> </paragraph> <paragraph num="(b)"> <text>Secretarial;</text> </paragraph> <paragraph num="(c)"> <text>Housekeeping;</text> </paragraph> <paragraph num="(d)"> <text>Supply maintenance;</text> </paragraph> <paragraph num="(e)"> <text>Equipment maintenance;</text> </paragraph> <paragraph num="(f)"> <text>Fabrication of straps for splinting and bracing;</text> </paragraph> <paragraph num="(g)"> <text>Fabrication of assistive devices that are not worn directly by a client;</text> </paragraph> <paragraph num="(h)"> <text>Routine transfers for transporting clients;</text> </paragraph> <paragraph num="(i)"> <text>Transporting clients; and</text> </paragraph> <paragraph num="(j)"> <text>Activities ancillary to group and individual activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Occupational Therapy Students. An occupational therapist or occupational therapy assistant supervising a Level I or Level II fieldwork student shall have a minimum of 1 year of experience as a licensed occupational therapist or occupational therapy assistant, excluding temporary licensure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Documentation Requirements for Supervision."> <paragraph num="A."> <text>Occupational Therapy Assistant. Documentation for supervision of an occupational therapy assistant shall include, but is not limited to:</text> <paragraph num="(1)"> <text>Reports or summaries documenting compliance with periodic supervision that are written and signed with credentials by the occupational therapy assistant and cosigned by the supervising occupational therapist;</text> </paragraph> <paragraph num="(2)"> <text>Documentation for planned discharges from the occupational therapy treatment program that are written and signed with credentials by the occupational therapy assistant and cosigned by the supervising occupational therapist; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of demonstrated competency in the use of specific procedures, activities, modalities, and techniques.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Temporary License to Practice Occupational Therapy. Documentation for supervision of an occupational therapist with a temporary license shall include, but is not limited to:</text> <paragraph num="(1)"> <text>Evaluations cosigned by the supervising occupational therapist;</text> </paragraph> <paragraph num="(2)"> <text>Reports or summaries documenting compliance with on-site supervision that are written and signed with credentials by the temporary occupational therapist and cosigned by the supervising occupational therapist;</text> </paragraph> <paragraph num="(3)"> <text>Cosigned revised treatment programs designed in response to changes in a client's status; and</text> </paragraph> <paragraph num="(4)"> <text>Documentation for planned discharges from the occupational therapy treatment program that are written and signed with credentials by the temporary occupational therapist and cosigned by the supervising occupational therapist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Temporary License to Practice Limited Occupational Therapy. Documentation for supervision of an occupational therapy assistant with a temporary license shall include:</text> <paragraph num="(1)"> <text>All client records cosigned by the supervisor;</text> </paragraph> <paragraph num="(2)"> <text>Reports or summaries documenting compliance with on-site supervision that are written and signed with credentials by the temporary occupational therapy assistant and cosigned by the supervising occupational therapist or occupational therapy assistant; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation for planned discharges from the occupational therapy treatment program that are written and signed with credentials by the temporary occupational therapy assistant and cosigned by the supervising occupational therapist.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Aides. The supervising occupational therapist or occupational therapy assistant shall:</text> <paragraph num="(1)"> <text>Be responsible for the safe and competent performance of tasks assigned to the aide; and</text> </paragraph> <paragraph num="(2)"> <text>Document evidence of unsafe or incompetent performance.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Occupational Therapy and Occupational Therapy Assistant Students Level I and Level II Fieldwork. Documentation for supervision of a Level I or Level II fieldwork occupational therapy or occupational therapy assistant student shall include:</text> <paragraph num="(1)"> <text>All client records cosigned by the supervisor;</text> </paragraph> <paragraph num="(2)"> <text>Reports or summaries documenting compliance with on-site supervision that are written and signed by the Level I or Level II fieldwork occupational therapy or occupational therapy assistant student and cosigned by the supervising occupational therapist or occupational therapy assistant; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation for planned discharges from the occupational therapy treatment program that are written and signed with credentials by the Level I or Level II fieldwork occupational therapy or occupational therapy assistant student and cosigned by the supervising occupational therapist.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Signature and Cosignature. Acceptable methods of authentication include a written signature or electronic signature that includes the signer's credentials.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Authority to Practice."> <text>It is unlawful for an individual who has a revoked, suspended, electively nonrenewed, or expired license status for any reason to:</text> <paragraph num="A."> <text>Practice occupational therapy in the State; or</text> </paragraph> <paragraph num="B."> <text>Use licensing credentials as specified in Regulation .07 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensure Status Representation."> <text>Individuals authorized to practice occupational therapy by the Board, and only those individuals, shall use the following credentials to represent licensure status to the public:</text> <paragraph num="A."> <text>Licensed occupational therapist (OT/L);</text> </paragraph> <paragraph num="B."> <text>Licensed occupational therapy assistant (OTA/L);</text> </paragraph> <paragraph num="C."> <text>Temporary occupational therapy licensee (OT/LT); and</text> </paragraph> <paragraph num="D."> <text>Temporary occupational therapy assistant licensee (OTA/LT).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Disclosure for Compelling Public Purpose."> <paragraph num="A."> <text>The Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, and may disclose the information under the following circumstances:</text> <paragraph num="(1)"> <text>The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="(2)"> <text>The information concerns a possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="(3)"> <text>The information concerns conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Other Disclosures. This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333(c); Health Occupations Article, §§10-101, 10-205, 10-301,10-302, 10-304, 10-311—10-313, 10-402, and 10-403; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 31, 1983 (10:2 Md. R. 109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 3, 1995 (22:13 Md. R. 968)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 3, 1995 (22:13 Md. R. 968)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed effective July 20, 1992 (19:14 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective July 3, 1995 (22:13 Md. R. 968)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective July 3, 1995 (22:13 Md. R. 968)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed and new Regulation .01—.06 adopted as an emergency provision effective October 1, 2000 (27:21 Md. R. 1973); emergency status extended at 28:7 Md. R. 687; emergency status extended at 28:9 Md. R. 884; adopted permanently effective April 30, 2001 (28:8 Md. R. 761)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 10, 2001 (28:24 Md. R. 2129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 10, 2001 (28:24 Md. R. 2129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective December 10, 2001 (28:24 Md. R. 2129)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 17, 2010 (37:10 Md. R. 722); September 14, 2015 (42:18 Md. R. 1174); October 23, 2017 (44:21 Md. R. 984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 17, 2010 (37:10 Md. R. 722); September 14, 2015 (42:18 Md. R. 1174); October 23, 2017 (44:21 Md. R. 984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective September 14, 2015 (42:18 Md. R. 1174)</annotation> </annotations> </chapter> <chapter num="02" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="General Conduct."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Provide appropriate services for clients without regard to age, race, creed, ethnicity, gender, lifestyle choices, impairment, disability, diagnosis, spirituality, or religious affiliation;</text> </paragraph> <paragraph num="(2)"> <text>Provide the highest quality services to the client;</text> </paragraph> <paragraph num="(3)"> <text>Show respect for the client's rights, including the right to refuse treatment;</text> </paragraph> <paragraph num="(4)"> <text>Follow all applicable laws regarding the client's privacy;</text> </paragraph> <paragraph num="(5)"> <text>Inform the client if the licensee determines that additional occupational therapy services would be beneficial;</text> </paragraph> <paragraph num="(6)"> <text>Recommend termination of services as appropriate to client needs, goals, and circumstances;</text> </paragraph> <paragraph num="(7)"> <text>Represent accurately the licensee's skills;</text> </paragraph> <paragraph num="(8)"> <text>Seek a consultation with or refer the client to an appropriate health care professional if the licensee determines that the licensee cannot effectively manage the client's needs;</text> </paragraph> <paragraph num="(9)"> <text>Exercise sound professional judgment in the use of evaluation and treatment procedures;</text> </paragraph> <paragraph num="(10)"> <text>Discontinue immediately a procedure which appears to be harmful to the client;</text> </paragraph> <paragraph num="(11)"> <text>Function with discretion and integrity in relations with other health professionals;</text> </paragraph> <paragraph num="(12)"> <text>Report to the Board a concern with the quality of the service provided by other health professionals;</text> </paragraph> <paragraph num="(13)"> <text>Ascertain whether all occupational therapy personnel within the facility are licensed if the licensee practices within a facility;</text> </paragraph> <paragraph num="(14)"> <text>Report to the Board a person whom the licensee believes to be performing or aiding and abetting the illegal practice of occupational therapy;</text> </paragraph> <paragraph num="(15)"> <text>Comply with all applicable laws dealing with occupational therapy practice;</text> </paragraph> <paragraph num="(16)"> <text>Accurately record and report all information related to continuing competency requirements as specified in COMAR 10.46.04;</text> </paragraph> <paragraph num="(17)"> <text>Provide information about fees upon request by a client;</text> </paragraph> <paragraph num="(18)"> <text>Notify the referring professional and the client if the licensee declines to carry out evaluation and treatment that has been ordered but that the licensee believes to be contraindicated or unjustified; and</text> </paragraph> <paragraph num="(19)"> <text>Comply with a lawful investigation conducted by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee may:</text> <paragraph num="(1)"> <text>Inform the patient's referring health professional if additional occupational therapy services would be beneficial to the patient; and</text> </paragraph> <paragraph num="(2)"> <text>Decline to carry out evaluation and treatment that has been requested but that the licensee believes is contraindicated or unjustified.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensee may not:</text> <paragraph num="(1)"> <text>Engage in a cruel, inhumane, or degrading practice in the treatment of the client;</text> </paragraph> <paragraph num="(2)"> <text>Allow financial gain to be paramount to the delivery of service to the client;</text> </paragraph> <paragraph num="(3)"> <text>Provide a service or instruction, either for pay or gratuitously, that is not within the licensee's demonstrated competencies; or</text> </paragraph> <paragraph num="(4)"> <text>Use, or participate in the use of, a form of communication that contains or implies a:</text> <paragraph num="(a)"> <text>Guarantee of satisfaction, except the guarantee to return a fee if the client is not satisfied with the treatment rendered, or</text> </paragraph> <paragraph num="(b)"> <text>False, fraudulent, misleading, deceptive, or unfair statement or claim.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Sexual Misconduct."> <paragraph num="A."> <text>The licensee shall avoid a relationship or an activity with the client that interferes with professional judgment and objectivity.</text> </paragraph> <paragraph num="B."> <text>The licensee may not:</text> <paragraph num="(1)"> <text>Exploit the client sexually, physically, emotionally, socially, or in another manner; or</text> </paragraph> <paragraph num="(2)"> <text>Engage in sexual misconduct which includes, but is not limited to, sexual behavior with the client or patient:</text> <paragraph num="(a)"> <text>Regardless of whether the behavior occurs in the context of a professional evaluation, treatment, procedure, or other service to the client or patient, or</text> </paragraph> <paragraph num="(b)"> <text>Under the pretense of diagnostic or therapeutic intent or benefit.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Professional Competence."> <text>An occupational therapist and occupational therapy assistant shall:</text> <paragraph num="A."> <text>Limit practice to the areas of competency by which proficiency has been gained through education, training, and experience;</text> </paragraph> <paragraph num="B."> <text>Acquire the education and training needed to address the cultural differences of diverse populations;</text> </paragraph> <paragraph num="C."> <text>Avoid unfair discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, sexual orientation, or other basis proscribed by law;</text> </paragraph> <paragraph num="D."> <text>Use treatment only when the occupational therapist or occupational therapy assistant knows that the circumstances are appropriate;</text> </paragraph> <paragraph num="E."> <text>Maintain competence by meeting the requirements of continuing education in accordance with COMAR 10.46.04;</text> </paragraph> <paragraph num="F."> <text>Engage in ongoing consultation with other occupational therapists and occupational therapy assistants or relevant professionals and seek appropriate education, training, and experience when developing competence in a new service or technique; and</text> </paragraph> <paragraph num="G."> <text>Document and maintain appropriate records of all relevant work and training used to gain competence in new techniques or services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Penalties."> <text>Violation of Regulation .01 or .02 of this chapter may result in the Board taking action to reprimand the licensee or place the licensee on probation, or to suspend or revoke the licensee's license.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 10-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 31, 1983 (10:2 Md. R. 109)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.03 adopted effective August 7, 2000 (27:15 Md. R. 1401)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective April 21, 2008 (35:8 Md. R. 805); April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 recodified to be Regulation .04 and new Regulation .03 adopted effective April 2, 2012 (39:6 Md. R. 409)</annotation> </annotations> </chapter> <chapter num="03" heading="Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all formal hearings before the Board of Occupational Therapy Practice. They do not apply to informal investigations, meetings, or proceedings when no formal ruling or decision is made.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the date, time, and place of the hearing. It shall also state the issues or charges involved in the proceeding.</text> </paragraph> <paragraph num="B."> <text>If, by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issues is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> <paragraph num="C."> <text>Service upon a party shall be delivery of the charging document and a copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>All parties appearing at formal hearings shall have the right to appear in proper person, or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Procedures."> <paragraph num="A."> <text>Prehearing Conferences. The Board may set a prehearing conference as it deems appropriate.</text> </paragraph> <paragraph num="B."> <text>Case Resolution Conference (CRC) Committee.</text> <paragraph num="(1)"> <text>One or more Board members comprise a committee which makes recommendations to the Board with regard to proposed disposition of matters before hearing.</text> </paragraph> <paragraph num="(2)"> <text>After service of charges or the response to the notice of intent to deny, the Board shall offer the respondent a case resolution conference (CRC).</text> </paragraph> <paragraph num="(3)"> <text>If there is no basis for an agreement between the respondent and the administrative prosecutor, the matter proceeds to hearing.</text> </paragraph> <paragraph num="(4)"> <text>Generally, one or two Board members compose the CRC committee.</text> </paragraph> <paragraph num="(5)"> <text>Except for consideration of a proposed resolution of a case achieved through the CRC, the Board may not make later use of any commentary, admissions, facts revealed, or positions taken, unless the subject matter is available from other sources or is otherwise discovered.</text> </paragraph> <paragraph num="(6)"> <text>Participation in a CRC is not ordinarily a basis for recusal of a Board member from further proceedings in the case.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Filing of Motions and Response. All motions shall be accompanied by a memorandum of points and authorities, and shall be filed with the Board at least 15 working days before the hearing. A copy shall be served on the opposing party. Any response shall be filed with the Board at least 10 working days before the hearing and copy served on the opposing party.</text> </paragraph> <paragraph num="D."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §C(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party, not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will be testifying at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Parties are not entitled to discovery of items other than as listed in §§C and D of this regulation.</text> </paragraph> <paragraph num="G."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="H."> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="J."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Board Majority. Except as provided in §B of this regulation, each hearing shall be held before a majority of the Board.</text> </paragraph> <paragraph num="B."> <text>Delegation. The Board may delegate the authority to conduct the hearing to a committee in accordance with Health Occupations Article, §10-316, Annotated Code of Maryland, or to an administrative law judge in accordance with State Government Article, §10-205, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The chairperson, or a member designated by the chairperson, shall be the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Admit evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence;</text> </paragraph> <paragraph num="(e)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer has discretion to set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall be responsible for decorum in a hearing and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board.</text> </paragraph> <paragraph num="(2)"> <text>Counsel presenting the case on behalf of the Board shall have the same rights with regard to the submission of evidence, examination, cross-examination of witnesses, presentation of summation and argument, and filing of objections, exceptions, and motions as does counsel for any party.</text> </paragraph> <paragraph num="(3)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Order of Procedure. The case on behalf of the Board shall be presented first. The respondent shall then present his case. After that, rebuttal shall be permitted.</text> </paragraph> <paragraph num="F."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Every party has the right to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine every witness called on behalf of the Board or other party;</text> </paragraph> <paragraph num="(c)"> <text>Present summation and argument, and file objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel.</text> </paragraph> <paragraph num="(4)"> <text>Witnesses.</text> <paragraph num="(a)"> <text>The presiding officer, or any person designated by him for that purpose, may examine any witness called to testify.</text> </paragraph> <paragraph num="(b)"> <text>The presiding officer may call as a witness any person in attendance at the hearing.</text> </paragraph> <paragraph num="(c)"> <text>Any member of the Board may examine any witness called to testify.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcripts."> <paragraph num="A."> <text>The Board shall prepare an official record which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceedings, or part of them, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <text>Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or his attorney of record.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>Any party aggrieved by the decision and order may apply for rehearing within 10 days after service of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it shall stay the enforcement of the order, or excuse the persons affected by it for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>On rehearing, the Board shall only consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§10-205 and 10-316; State Government Article, §§10-205 and 10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 31, 1983 (10:2 Md. R. 109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 1, 2000 (27:17 Md. R. 1620); April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 1, 2000 (27:17 Md. R. 1620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective January 30, 1995 (22:2 Md. R. 77); April 21, 2008 (35:8 Md. R. 805)</annotation> </annotations> </chapter> <chapter num="04" heading="Continuing Competency Requirement"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to all occupational therapists and occupational therapy assistants seeking to obtain, renew, reactivate, or reinstate licensure in Maryland.</text> </paragraph> <paragraph num="B."> <text>The objectives of this chapter are to establish guidelines in order to:</text> <paragraph num="(1)"> <text>Maintain professional competency, or improve professional competency, or both; and</text> </paragraph> <paragraph num="(2)"> <text>Assure completion of continuing competency requirements for:</text> <paragraph num="(a)"> <text>Licensure;</text> </paragraph> <paragraph num="(b)"> <text>Renewal;</text> </paragraph> <paragraph num="(c)"> <text>Reactivation; or</text> </paragraph> <paragraph num="(d)"> <text>Reinstatement.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Competence” means an individual's capacity for performance in occupational therapy principles and procedures.</text> </paragraph> <paragraph num="(2)"> <text>Competency.</text> <paragraph num="(a)"> <text>“Competency” means the demonstration of the pertinent knowledge of and performance skills in occupational therapy principles and procedures within the practice of occupational therapy and limited occupational therapy.</text> </paragraph> <paragraph num="(b)"> <text>“Competency” includes satisfactory completion of an educational program or experience, specialty certification, continuing education, or all of these.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Contact Hour.</text> <paragraph num="(a)"> <text>“Contact hour” means 1 hour spent in a continuing competency activity that meets the requirements of the Board and is approved as set forth in this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Contact hour” does not include orientations, introductions, refreshment breaks, receptions, other social gatherings, and meals which do not include an acceptable educational activity.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Contact hour approval request” means a form provided by the Board for the purpose of obtaining Board approval of contact hours.</text> </paragraph> <paragraph num="(5)"> <text>“Continuing competency committee” means a committee established and appointed by the Board to evaluate continuing competency programs and activities.</text> </paragraph> <paragraph num="(6)"> <text>“Continuing competency requirement compliance report” means a form provided by the Board for the purpose of summarizing completion of continuing competency requirements.</text> </paragraph> <paragraph num="(7)"> <text>“Occupational therapy principles” means:</text> <paragraph num="(a)"> <text>The use of therapeutic activities that promote independence in daily life roles;</text> </paragraph> <paragraph num="(b)"> <text>Remediation or restoration of performance abilities that are limited due to impairment in biological, physiological, psychological, or neurological processes;</text> </paragraph> <paragraph num="(c)"> <text>In order to enhance performance, the adaptation of task, process, or the environment, or the teaching of compensatory techniques;</text> </paragraph> <paragraph num="(d)"> <text>Methods and techniques for preventing disability that facilitate the development of the safe application of performance skills;</text> </paragraph> <paragraph num="(e)"> <text>Health promotion strategies and practices that enhance performance abilities; and</text> </paragraph> <paragraph num="(f)"> <text>Education, instruction, and research in the practice of occupational therapy.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Occupational Therapy Procedures.</text> <paragraph num="(a)"> <text>“Occupational therapy procedures” means:</text> <paragraph num="(i)"> <text>Developing, improving, sustaining, or restoring skills in activities of daily living, work, or productive activities, including instrumental activities of daily living and play and leisure activities;</text> </paragraph> <paragraph num="(ii)"> <text>Developing, remediating, or restoring sensorimotor, perceptual, cognitive, or psychological components of performance;</text> </paragraph> <paragraph num="(iii)"> <text>Designing, fabricating, applying, or training in the use of assistive technology, splinting, or orthotic devices, including training in the use of prosthetic devices;</text> </paragraph> <paragraph num="(iv)"> <text>Adapting environments and processes, including the application of ergonomic principles to enhance performance and safety in daily life roles;</text> </paragraph> <paragraph num="(v)"> <text>Applying physical agent modalities as adjuncts to or in preparation for purposeful activity with appropriate training, as specified;</text> </paragraph> <paragraph num="(vi)"> <text>Promoting safe, functional mobility in daily life tasks;</text> </paragraph> <paragraph num="(vii)"> <text>Providing intervention in collaboration with the client, the client's family, the client's caregiver, or others;</text> </paragraph> <paragraph num="(viii)"> <text>Educating the client, the client's family, the client's caregiver, or others in carrying out appropriate nonskilled interventions; and</text> </paragraph> <paragraph num="(ix)"> <text>Consulting with groups, programs, organizations, and communities to provide population-based services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Occupational therapy procedures” do not include the adjustment or manipulation of any of the osseous structures of the body or spine.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Occupational Therapy Role-Related Activities.</text> <paragraph num="(a)"> <text>“Occupational therapy role-related activities” means activities which are relevant to and that augment a licensee's professional, job-related duties and responsibilities.</text> </paragraph> <paragraph num="(b)"> <text>“Occupational therapy role-related activities” may include inservices, course work, or workshops relative to:</text> <paragraph num="(i)"> <text>Health care administration, management, or leadership;</text> </paragraph> <paragraph num="(ii)"> <text>Other disciplines' clinical practices that relate to occupational therapy principles and procedures;</text> </paragraph> <paragraph num="(iii)"> <text>Billing and regulatory issues;</text> </paragraph> <paragraph num="(iv)"> <text>Health care computer programs that provide information to benefit clients or client education; or</text> </paragraph> <paragraph num="(v)"> <text>Cultural competency.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Occupational therapy role-related activities” do not include:</text> <paragraph num="(i)"> <text>Preparation for national or regional standardized tests, such as the Graduate Record Examination;</text> </paragraph> <paragraph num="(ii)"> <text>Cardiopulmonary resuscitation (CPR);</text> </paragraph> <paragraph num="(iii)"> <text>Job or facility orientation activities;</text> </paragraph> <paragraph num="(iv)"> <text>Certificate or degree programs in unrelated fields; or</text> </paragraph> <paragraph num="(v)"> <text>Foreign language classes for personal use.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Provider” means a college, university, institution, organization, association, or individual that offers workshops, seminars, conferences, college-level courses, graduate-level courses, telecommunication network courses, or video-taped presentations that maintain or improve professional competency.</text> </paragraph> <paragraph num="(11)"> <text>“Verification” means proof of licensure, certification, registration, or continuing education:</text> <paragraph num="(a)"> <text>Confirmable by the Board based on documentation provided by the applicant.</text> </paragraph> <paragraph num="(b)"> <text>Obtained from a verification service provider approved by the issuing entity and accepted by the Board at its discretion; or</text> </paragraph> <paragraph num="(c)"> <text>Obtained from the entity by which the applicant is licensed, certified, registered, or educated.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Maintaining Records of Contact Hours."> <paragraph num="A."> <text>A licensee shall retain supporting documents relative to continuing competency requirements for a period of 4 years after the date of renewal for inspection by the Board. These documents may be audited by the Board at any time.</text> </paragraph> <paragraph num="B."> <text>A licensee shall retain physical agent modality documentation for the duration of the licensee's professional career in occupational therapy, in accordance with COMAR 10.46.06.</text> </paragraph> <paragraph num="C."> <text>At the time of licensure, renewal, reactivation, or reinstatement, a licensee shall attest to completion of the required contact hours during the specified time frame.</text> </paragraph> <paragraph num="D."> <text>A licensee's submission of any false statement regarding continuing competency requirements shall result in formal disciplinary action by the Board.</text> </paragraph> <paragraph num="E."> <text>A licensee's failure to substantiate contact hours upon request of the Board shall result in formal disciplinary action by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure and Contact Hour Requirements."> <paragraph num="A."> <text>Time Frame.</text> <paragraph num="(1)"> <text>Licensure Time Frame.</text> <paragraph num="(a)"> <text>The Board shall stagger the terms of licenses.</text> </paragraph> <paragraph num="(b)"> <text>A license is valid for a 2-year term and expires as follows:</text> <paragraph num="(i)"> <text>Licensees originally licensed in even-numbered years are issued a license that expires on June 30 of even-numbered years; and</text> </paragraph> <paragraph num="(ii)"> <text>Licensees originally licensed in odd-numbered years are issued a license that expires on June 30 of odd-numbered years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Continuing Competency Time Frame. Continuing competency requirements shall be completed within the applicable licensure time frame.</text> </paragraph> <paragraph num="(3)"> <text>The licensee may not carry over contact hours from one continuing competency time frame to another without written consent from the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Requirements Regarding Contact Hours.</text> <paragraph num="(1)"> <text>The occupational therapist or occupational therapy assistant shall certify a minimum of 24 contact hours of competency activities obtained within the 2-year period preceding the application for licensure, reactivation, or reinstatement.</text> </paragraph> <paragraph num="(2)"> <text>The 24 contact hours referred to in §B(1) of this regulation shall consist of:</text> <paragraph num="(a)"> <text>A minimum of 16 contact hours related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(b)"> <text>A maximum of 8 contact hours through occupational therapy role-related activities.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The occupational therapist or occupational therapy assistant shall provide the necessary documentation to the Board upon request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Exceptions.</text> <paragraph num="(1)"> <text>Maintenance of Current Certification with the National Board of Certification in Occupational Therapy (NBCOT).</text> <paragraph num="(a)"> <text>The Board recognizes the maintenance of current NBCOT certification as fulfilling the requirements of §B(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>Documentation. The licensee shall provide verification of maintenance of current NBCOT certification.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Licensed Less Than 1 Year. An occupational therapist or occupational therapist assistant who has had a license less than 1 year before renewal is exempt from continuing competency requirements for the first renewal period.</text> </paragraph> <paragraph num="(3)"> <text>Requesting Licensure with 3 or More Years Lapse in Practice.</text> <paragraph num="(a)"> <text>When an applicant applies for licensure, renewal, reactivation, or reinstatement, and meets all requirements for licensure, renewal, reactivation, or reinstatement, but has not graduated from an accredited occupational therapy program or practiced occupational therapy within the past 3 years or more, the Board shall require verification of the applicant's efforts toward maintaining and updating occupational therapy clinical competency.</text> </paragraph> <paragraph num="(b)"> <text>If an individual has been out of practice for between 3 and 8 years, the individual shall:</text> <paragraph num="(i)"> <text>Complete a Board-approved self-assessment;</text> </paragraph> <paragraph num="(ii)"> <text>Complete a Board-approved professional development plan;</text> </paragraph> <paragraph num="(iii)"> <text>Attend a minimum of 24 contact hours related to occupational therapy principles and procedures within the 24 months preceding application for licensure, renewal, reactivation, or reinstatement;</text> </paragraph> <paragraph num="(iv)"> <text>Provide verification of a minimum of 30 hours of observation of service delivery, receipt of mentoring, or a combination of both with an actively licensed occupational therapist within the 24 months preceding application for licensure, renewal, reactivation, or reinstatement; and</text> </paragraph> <paragraph num="(v)"> <text>Document completion of established goals and activities in occupational therapy with an actively licensed occupational therapist within the 24 months preceding application for licensure renewal, reactivation, or reinstatement.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If an individual has been out of practice for longer than 8 years, the individual shall:</text> <paragraph num="(i)"> <text>Complete the requirements in §C(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide verification of 6 additional contact hours related to occupational therapy principles and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Before the deadline to complete continuing competency, a licensee may request an extension to the specified time frame for completing continuing competency requirements by submitting:</text> <paragraph num="(a)"> <text>A letter of request;</text> </paragraph> <paragraph num="(b)"> <text>Documentation substantiating the basis of the request, for example, medical documentation; and</text> </paragraph> <paragraph num="(c)"> <text>A plan for completing the requirement.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Approval of Contact Hour Programs."> <paragraph num="A."> <text>The Board preapproves contact hours provided by:</text> <paragraph num="(1)"> <text>The American Occupational Therapy Association (AOTA);</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Occupational Therapy Association (MOTA);</text> </paragraph> <paragraph num="(3)"> <text>AOTA-approved providers; and</text> </paragraph> <paragraph num="(4)"> <text>The National Board for Certification in Occupational Therapy (NBCOT).</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provider Procedures for Board Approval. A provider offering a program related to occupational therapy principles and procedures who wishes to obtain Board review of contact hours being offered to participants in the provider's programs shall submit to the Board at least 60 days in advance of the program:</text> <paragraph num="(1)"> <text>A contact hour approval request;</text> </paragraph> <paragraph num="(2)"> <text>An hour-by-hour agenda of the course;</text> </paragraph> <paragraph num="(3)"> <text>A course description;</text> </paragraph> <paragraph num="(4)"> <text>A description of the qualifications of the presenter or speaker, or both;</text> </paragraph> <paragraph num="(5)"> <text>A sample of the certificate of completion that will be provided to course participants; and</text> </paragraph> <paragraph num="(6)"> <text>A money order, check, or electronic payment in the amount of the course review fee established by the Board in COMAR 10.46.05.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Upon review of the completed application, the Board shall notify the provider as to whether or not the program has been approved, and, if approved, the number of contact hours awarded.</text> </paragraph> <paragraph num="D."> <text>A provider shall furnish a certificate of completion to all participants, specifying the following information:</text> <paragraph num="(1)"> <text>Name of the participant;</text> </paragraph> <paragraph num="(2)"> <text>Name of the provider;</text> </paragraph> <paragraph num="(3)"> <text>Dates of the course and completion;</text> </paragraph> <paragraph num="(4)"> <text>Title and location of the course;</text> </paragraph> <paragraph num="(5)"> <text>Number of contact hours awarded by the Board; and</text> </paragraph> <paragraph num="(6)"> <text>Signature of the provider or representative.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Licensee Procedures for Board Approval. A licensee participating in a program related to occupational therapy principles and procedures who wishes to obtain Board approval of contact hours not previously reviewed shall submit to the Board the following materials:</text> <paragraph num="(1)"> <text>A contact hour approval request;</text> </paragraph> <paragraph num="(2)"> <text>An hour-by-hour agenda of the course;</text> </paragraph> <paragraph num="(3)"> <text>A course description;</text> </paragraph> <paragraph num="(4)"> <text>A description of the presenter's qualifications; and</text> </paragraph> <paragraph num="(5)"> <text>A sample of the certificate of completion that will be provided to course participants.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Upon review of the completed application, the Board shall notify the licensee as to whether or not the course has been approved, and, if approved, the number of contact hours awarded.</text> </paragraph> <paragraph num="G."> <text>The Board may not review occupational therapy role-related activities for pre-approval.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Continuing Competency Activities."> <paragraph num="A."> <text>A licensee may accrue contact hours by being involved in a broad variety of programs and activities to maintain professional competency.</text> </paragraph> <paragraph num="B."> <text>A minimum of 16 hours is required to be earned through continuing competencies related to occupational therapy principles and procedures.</text> </paragraph> <paragraph num="C."> <text>A maximum of 8 hours may be earned through occupational therapy role-related activities.</text> </paragraph> <paragraph num="D."> <text>Continuing competency activities that are approved by the Board include activities described in §E of this regulation in which the licensee may participate, present, or complete independently.</text> </paragraph> <paragraph num="E."> <text>Continuing Competency Activities — Specific Requirements.</text> <paragraph num="(1)"> <text>Workshops, Seminars, Conferences.</text> <paragraph num="(a)"> <text>A licensee may attend workshops, seminars, lectures, or professional conferences and receive 1 contact hour per 1 hour of attendance.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>24 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A certificate of completion.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Additional Documentation. In addition to the requirements of §E(1)(c) of this regulation, for courses not preapproved, a licensee shall include the following additional documentation:</text> <paragraph num="(i)"> <text>The date, location, and hour-by-hour agenda of the course;</text> </paragraph> <paragraph num="(ii)"> <text>A course description;</text> </paragraph> <paragraph num="(iii)"> <text>A description of the presenter's qualifications; and</text> </paragraph> <paragraph num="(iv)"> <text>A certificate of completion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>University, College, Adult Education Courses.</text> <paragraph num="(a)"> <text>A licensee may attend formal academic courses in occupational therapy or related topics at a university or college and receive 8 contact hours per credit hour earned.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>24 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>An original, official transcript indicating successful completion of the course; and</text> </paragraph> <paragraph num="(iii)"> <text>A description of the course from the school catalogue or course syllabus.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Fellowship Training.</text> <paragraph num="(a)"> <text>A licensee may attend fellowship training in a specific area and receive 24 contact hours (a minimum of 12 full-time weeks).</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>24 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>A certificate awarded from the accredited organization;</text> </paragraph> <paragraph num="(iii)"> <text>The dates of attendance; and</text> </paragraph> <paragraph num="(iv)"> <text>A description of the training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Specialty Certification.</text> <paragraph num="(a)"> <text>A licensee may attain a specialty certification (for example, certified hand therapist) and receive 1 contact hour per 1 hour of education.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>20 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A certificate of completion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Physical Agent Modalities (PAMS).</text> <paragraph num="(a)"> <text>A licensee may participate by following the requirements for applying PAMS as set forth in COMAR 10.46.06.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>24 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>A certificate of completion;</text> </paragraph> <paragraph num="(iii)"> <text>An official grade report or transcript;</text> </paragraph> <paragraph num="(iv)"> <text>A course syllabus; and</text> </paragraph> <paragraph num="(v)"> <text>Written verification from the educator of five patient treatments.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Auditing.</text> <paragraph num="(a)"> <text>A licensee may audit formal occupational therapy academic course work and receive 4 contact hours per credit hour.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>A letter from the instructor regarding the time spent in the classroom/lab from an accredited college/university; and</text> </paragraph> <paragraph num="(iii)"> <text>A report by the licensee on the learning objectives accomplished.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Internet Learning.</text> <paragraph num="(a)"> <text>A licensee may participate in on-line courses and receive 1 contact hour per 1 hour of education.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>An abstract of the content; and</text> </paragraph> <paragraph num="(iii)"> <text>Verification of course completion from the course provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Informal Self-Study.</text> <paragraph num="(a)"> <text>A licensee may participate through journal articles, or other reading opportunities with assessment, text books, video and audio tape, television, electronic media, seminars, workshops, and presentations and receive 1 contact hour per 1 hour of education.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>An abstract of content from the provider; or</text> </paragraph> <paragraph num="(iii)"> <text>Verification of completion from the course provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(9)"> <text>In-Service Training.</text> <paragraph num="(a)"> <text>A licensee may attend an employer-provided occupational therapy in-service training program on principles, procedures, or occupational therapy related continuing education and receive 1 contact hour per 1 hour of education.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>The date, location, and hour-by-hour outline or abstract of content from the in-service provider;</text> </paragraph> <paragraph num="(iii)"> <text>The course description;</text> </paragraph> <paragraph num="(iv)"> <text>The presenter's qualifications; and</text> </paragraph> <paragraph num="(v)"> <text>Verification of participation from the in-service provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>Mentoring.</text> <paragraph num="(a)"> <text>A licensee may receive 1 contact hour per 4 hours of:</text> <paragraph num="(i)"> <text>Mentoring an occupational therapy colleague to improve the skills of the protege, including the role as disciplinary monitor;</text> </paragraph> <paragraph num="(ii)"> <text>Mentoring licensed occupational therapy professionals to improve their clinical skills;</text> </paragraph> <paragraph num="(iii)"> <text>Mentoring other health care professionals to improve staff clinical skills;</text> </paragraph> <paragraph num="(iv)"> <text>Mentoring management/administrative/academic skills as an occupational therapy professional; or</text> </paragraph> <paragraph num="(v)"> <text>Being mentored in a formally structured independent, concentrated, didactic or applied learning experience overseen by a mentor.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>8 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>The goals, objectives, and analysis of performance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>Presentations by Licensee of Occupational Therapy Education Programs, Workshops, Seminars, and In-Services.</text> <paragraph num="(a)"> <text>A licensee may:</text> <paragraph num="(i)"> <text>Make presentations for local organizations, associations, or groups on an occupational therapy related topic;</text> </paragraph> <paragraph num="(ii)"> <text>Make professional presentations at state, national, or international workshops, seminars, or conferences; or</text> </paragraph> <paragraph num="(iii)"> <text>Provide professional in-service training or instruction for occupational therapists, occupational therapy assistants, or related professionals.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Contact hours are earned at twice the amount of the actual presentation time.</text> </paragraph> <paragraph num="(c)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>An hour-by-hour schedule of the presentation; and</text> </paragraph> <paragraph num="(iii)"> <text>An announcement of the meeting, or letter of acknowledgement from the professional sponsoring the event, or both.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Presentations of the content are credited only once per renewal cycle.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Development of Instructional Materials.</text> <paragraph num="(a)"> <text>A licensee may develop instructional materials using alternative media such as video, audio, or software programs to advance professional skills of others (not for proprietary use) and receive 1 contact hour per 3 hours of work.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the program; and</text> </paragraph> <paragraph num="(iii)"> <text>Media or software materials.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>Poster Presentations.</text> <paragraph num="(a)"> <text>A licensee may present posters for state, national, or international workshops, seminars, or conferences and receive contact hours at twice the amount of the actual presentation time.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A copy of the presentation or program listing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Presentations of the content are credited only once per renewal cycle.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Academic Guest Lecturer.</text> <paragraph num="(a)"> <text>If it is not a licensee's primary role, a licensee may teach one occupational therapy related academic course per semester and receive twice the contact hours per credit hour taught.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>The date and lecture or academic course title;</text> </paragraph> <paragraph num="(iii)"> <text>The name of the institution;</text> </paragraph> <paragraph num="(iv)"> <text>A letter from the instructor regarding the time spent in the classroom;</text> </paragraph> <paragraph num="(v)"> <text>Course or lecture goals and objectives; and</text> </paragraph> <paragraph num="(vi)"> <text>Number of hours actually taught.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Presentations of the content are credited only once per renewal cycle.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Fieldwork Supervision.</text> <paragraph num="(a)"> <text>If it is not a licensee's primary role, a licensee may directly supervise the fieldwork of Level I or Level II occupational therapy students and receive 2 contact hours per Level I occupational therapy student or 8 contact hours per Level II occupational therapy student.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>Verification from each student's college.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(16)"> <text>Text Book or Articles Published or Accepted for Publication.</text> <paragraph num="(a)"> <text>A licensee may participate through:</text> <paragraph num="(i)"> <text>Publication of an occupational therapy or related professional textbook;</text> </paragraph> <paragraph num="(ii)"> <text>Professional manuscript published or reviewed (edited) for textbooks;</text> </paragraph> <paragraph num="(iii)"> <text>Publication of chapter or chapters in an occupational therapy or related professional textbook;</text> </paragraph> <paragraph num="(iv)"> <text>Publication of an occupational therapy article in a peer-reviewed publication; or</text> </paragraph> <paragraph num="(v)"> <text>Publication of an occupational therapy article in a nonpeer-reviewed publication.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>20 contact hours from authorship, editorship, coauthorship, coeditorship, or all of these, of a book for occupational therapists or relating to occupational therapy;</text> </paragraph> <paragraph num="(ii)"> <text>10 contact hours for authorship or editorship of a chapter of a publication;</text> </paragraph> <paragraph num="(iii)"> <text>8 contact hours for authorship or editorship of an occupational therapy article or abstract in a peer-reviewed publication; or</text> </paragraph> <paragraph num="(iv)"> <text>4 contact hours for authorship or editorship of an occupational therapy-related article or abstract in a nonpeer-reviewed publication.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A copy of the published work.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(17)"> <text>Research Projects.</text> <paragraph num="(a)"> <text>A licensee may participate through extensive scholarly research activities or extensive outcome studies (defined as research associated with, for example, grants, postgraduate studies, or peer-reviewed journals).</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>10 contact hours per research project as approved by the Board toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>Copies of research proposals and final results of the research to the continuing competency committee for approval and determination of the number of contact hours earned.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>Evaluator.</text> <paragraph num="(a)"> <text>A licensee may participate through quality assurance or program evaluation studies completed and published in a journal or newsletter.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>4 contact hours per study for quality assurance or program evaluation studies completed and published toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A copy of the evaluation study to the continuing competency committee for approval and determination of the number of contact hours earned.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>Reviewer/Editor.</text> <paragraph num="(a)"> <text>A licensee may review professional journal articles, papers, textbook chapters, or professional association conference presentations and receive 1/2 contact hour for each paper or proposal reviewed.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 contact hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>Confirmation from the sponsoring journal, publisher, or organization, including the number of reviews completed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>Professional Study Group.</text> <paragraph num="(a)"> <text>A licensee may participate through professional study groups or online study groups designed to advance knowledge through active participation and receive 1 contact hour per 3 hours of study.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>12 contact hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>Group attendance records;</text> </paragraph> <paragraph num="(iii)"> <text>Study group goals; and</text> </paragraph> <paragraph num="(iv)"> <text>Analysis of goal attainment and learning.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>Jurisprudence Examination.</text> <paragraph num="(a)"> <text>A licensee may participate by successfully completing the Board's Jurisprudence Examination and receive 1 contact hour.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of 1 contact hours toward the continuing competency requirement related to occupational therapy principles and procedures.</text> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A certificate of completion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(22)"> <text>Volunteer Services.</text> <paragraph num="(a)"> <text>A licensee may volunteer occupational therapy services in areas of the licensee's expertise to community organizations, individuals, and populations, or volunteer on occupational therapy professional and related boards, associations, and committees for setting standards and the promotion of occupational therapy, and receive 1 contact hour per 1 hour of volunteering.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>8 contact hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report;</text> </paragraph> <paragraph num="(ii)"> <text>A verification letter from the organization to which services were volunteered; and</text> </paragraph> <paragraph num="(iii)"> <text>A letter describing outcomes of the volunteer service provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>Formal Self-Study.</text> <paragraph num="(a)"> <text>A licensee may participate in formal self-study activities through an independent, concentrated didactic, or applied learning experience, or both. The copyright on the materials used for study may not precede the submission date by more than 5 years.</text> </paragraph> <paragraph num="(b)"> <text>Every 2 years, a licensee may apply a maximum of:</text> <paragraph num="(i)"> <text>16 contact hours toward the continuing competency requirement related to occupational therapy principles and procedures; and</text> </paragraph> <paragraph num="(ii)"> <text>8 hours toward the continuing competency option for role-related activities.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Documentation. The licensee shall provide:</text> <paragraph num="(i)"> <text>A continuing competency requirement compliance report; and</text> </paragraph> <paragraph num="(ii)"> <text>A certificate of completion or provider-signed summary to include subject area, credentials of supervisor, didactic resources, clinical experience, time frame, and relevance to licensee's professional practice.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Audit of Continuing Competency."> <paragraph num="A."> <text>At the Board's discretion, the Board shall audit the continuing competency documentation of a number of randomly selected licensees.</text> </paragraph> <paragraph num="B."> <text>The Board shall send notification of audit to audited licensees.</text> </paragraph> <paragraph num="C."> <text>A licensee is subject to an audit of the licensee’s continuing competency documentation by the Board as a condition of renewal of licensure.</text> </paragraph> <paragraph num="D."> <text>An audited licensee shall successfully complete the requirement of the audit by the specified deadline.</text> </paragraph> <paragraph num="E."> <text>The Board may take formal disciplinary action against the licensee if a licensee:</text> <paragraph num="(1)"> <text>Fails to cooperate with an audit or a request from the Board regarding continuing competency documentation; or</text> </paragraph> <paragraph num="(2)"> <text>Submits a false statement regarding continuing competency.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§10-205 and 10-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 29, 1985 (12:15 Md. R. 1520)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective March 27, 1995 (22:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 27, 1995 (22:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04—.07 repealed and new Regulations .04—.07 adopted effective March 27, 1995 (22:6 Md. R. 474)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 repealed and new Regulations .01—.08 adopted effective October 2, 2000 (27:19 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective February 21, 2011 (38:4 Md. R. 264); February 29, 2016 (43:4 Md. R. 332); October 23, 2017 (44:21 Md. R. 984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 21, 2011 (38:4 Md. R. 264); February 29, 2016 (43:4 Md. R. 332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 23, 2017 (44:21 Md. R. 984)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective May 27, 2013 (40:10 Md. R. 917)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 21, 2011 (38:4 Md. R. 264)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 29, 2016 (43:4 Md. R. 332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 21, 2011 (38:4 Md. R. 264); February 29, 2016 (43:4 Md. R. 332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective February 29, 2016 (43:4 Md. R. 332)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E adopted effective October 23, 2017 (44:21 Md. R. 984)</annotation> </annotations> </chapter> <chapter num="05" heading="Collection of Fees"> <regulation prefix="Regulation" num=".01" heading="Fees."> <text>The fees established by the Board are as follows:</text> <paragraph num="A."> <text>Address change, failure to notify the Board — $50;</text> </paragraph> <paragraph num="B."> <text>Application for initial licensure (includes first temporary license and is nonrefundable) — $200;</text> </paragraph> <paragraph num="C."> <text>Application for second temporary license — $50;</text> </paragraph> <paragraph num="D."> <text>Continuing Competency Provider Contact Hour review — $30;</text> </paragraph> <paragraph num="E."> <text>Insufficient Funds — $35;</text> </paragraph> <paragraph num="F."> <text>Reactivation of license after elective nonrenewal — $245;</text> </paragraph> <paragraph num="G."> <text>Reinstatement — $450;</text> </paragraph> <paragraph num="H."> <text>Elective nonrenewal — $25;</text> </paragraph> <paragraph num="I."> <text>Renewal, late fee (applicable to renewal made after the renewal deadline) — $100;</text> </paragraph> <paragraph num="J."> <text>Renewal, occupational therapist license — $270;</text> </paragraph> <paragraph num="K."> <text>Renewal, occupational therapy assistant license —$210;</text> </paragraph> <paragraph num="L."> <text>Verification of licensure — $20;</text> </paragraph> <paragraph num="M."> <text>Interstate occupational therapy licensure compact fee — $125.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Assessment for Health Care Professionals."> <text>At the time of license renewal an occupational therapist shall pay a fee for health care professionals assessed by the Maryland Health Care Commission (MHCC), as specified in COMAR 10.25.02.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§10-205 and 10-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 20, 1992 (19:14 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective October 1, 1993 (20:20 Md. R. 1566); amended permanently effective April 2, 1994 (20:22 Md. R. 1708)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 3, 1997 (24:22 Md. R. 1552); August 21, 2000 (27:16 Md. R. 1526)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended and Regulation .02 adopted as an emergency provision effective August 31, 2001 (28:19 Md. R. 1681); adopted permanently effective December 10, 2001 (28:24 Md. R. 2129)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 15, 2004 (31:5 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01M adopted effective October 27, 2025 (52:21 Md. R. 1024)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective April 21, 2008 (35:8 Md. R. 805)</annotation> </annotations> </chapter> <chapter num="06" heading="Competency Requirements for Physical Agent Modalities"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter sets forth the requirements for licensed occupational therapists and licensed occupational therapy assistants to apply and use electrical and superficial physical agent modalities as related to, or in preparation for, purposeful activity, with appropriate education to ensure the safe and competent provision of occupational therapy services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Exceptions."> <text>A licensee who is credentialed as a certified hand therapist is exempt from the requirements set forth in this chapter.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Didactic education” means an educational activity:</text> <paragraph num="(a)"> <text>That includes a method of evaluating and testing the knowledge of the licensee relative to electrical physical agent modalities; and</text> </paragraph> <paragraph num="(b)"> <text>Relevant to the practice of electrical physical agent modalities in occupational therapy including:</text> <paragraph num="(i)"> <text>In-service education;</text> </paragraph> <paragraph num="(ii)"> <text>Conferences;</text> </paragraph> <paragraph num="(iii)"> <text>Workshops;</text> </paragraph> <paragraph num="(iv)"> <text>Seminars;</text> </paragraph> <paragraph num="(v)"> <text>Formal graduate academic education; or</text> </paragraph> <paragraph num="(vi)"> <text>Formal undergraduate academic education.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Direct clinical education” means supervised instruction provided on a face-to-face basis by the educator during the application of electrical physical agent modalities to a client.</text> </paragraph> <paragraph num="(3)"> <text>“Educator” means an individual who has successfully met the competency requirements as set forth in this chapter and provides didactic or direct clinical education, or both, but does not need to be an occupational therapist or occupational therapy assistant.</text> </paragraph> <paragraph num="(4)"> <text>Electrical Physical Agent Modalities.</text> <paragraph num="(a)"> <text>“Electrical physical agent modalities” means therapeutic modalities which induce heat or electrical current beneath the skin.</text> </paragraph> <paragraph num="(b)"> <text>“Electrical physical agent modalities” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Therapeutic ultrasound;</text> </paragraph> <paragraph num="(ii)"> <text>Phonophoresis;</text> </paragraph> <paragraph num="(iii)"> <text>Iontophoresis; and</text> </paragraph> <paragraph num="(iv)"> <text>Electromuscular stimulation (FES), including biofeedback, transcutaneous electrical nerve stimulation (TENS) and laser light therapy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Superficial physical agent modalities” means therapeutic modalities including, but not limited to:</text> <paragraph num="(a)"> <text>Hot packs;</text> </paragraph> <paragraph num="(b)"> <text>Cold packs;</text> </paragraph> <paragraph num="(c)"> <text>Paraffin;</text> </paragraph> <paragraph num="(d)"> <text>Fluidotherapy; and</text> </paragraph> <paragraph num="(e)"> <text>Icing.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Competence for Electrical Modalities."> <paragraph num="A."> <text>An occupational therapist, or occupational therapy assistant under the periodic supervision of an occupational therapist, who wishes to use occupational therapy procedures involving electrical physical agent modalities shall maintain, for the duration of the licensee's professional career, verification of didactic education and clinical requirements.</text> </paragraph> <paragraph num="B."> <text>Didactic Education. For each electrical physical agent modality, didactic education shall include:</text> <paragraph num="(1)"> <text>Principles of physics related to specific properties of light, water, temperature, sound, and electricity;</text> </paragraph> <paragraph num="(2)"> <text>Physiological, neurophysiological, and electrophysiological changes which occur as a result of the application of the selected modality;</text> </paragraph> <paragraph num="(3)"> <text>The response of normal and abnormal tissue to the application of the modality;</text> </paragraph> <paragraph num="(4)"> <text>Indications and contraindications related to the selection and application of the modality;</text> </paragraph> <paragraph num="(5)"> <text>The guidelines for treatment or administration of the modality within the philosophical framework of occupational therapy;</text> </paragraph> <paragraph num="(6)"> <text>The guidelines for educating the patient, including instructing the patient about the process and possible outcomes of treatment, including its risks and benefits;</text> </paragraph> <paragraph num="(7)"> <text>Safety rules and precautions related to the selected modality;</text> </paragraph> <paragraph num="(8)"> <text>Methods of documenting the effectiveness of immediate and long-term effects of treatment;</text> </paragraph> <paragraph num="(9)"> <text>Characteristics of equipment including safe operation, adjustment, and care of the equipment; and</text> </paragraph> <paragraph num="(10)"> <text>Application and storage of patient specific pharmacological agents.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical Requirements. Before applying physical agent modalities to a client under this chapter, a licensee shall:</text> <paragraph num="(1)"> <text>Complete 15 contact hours of continuing education relative to electrical physical agent modalities which includes a minimum of:</text> <paragraph num="(a)"> <text>5 contact hours specific to ultrasound; and</text> </paragraph> <paragraph num="(b)"> <text>5 contact hours specific to electromuscular stimulation; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>After completing all 15 contact hours of education, a licensee shall apply a minimum of five client treatments within the context of a therapeutic treatment program for each specific modality under the direct clinical education of an educator as defined in this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Treatment Plan Guidelines for Physical Agent Modalities."> <paragraph num="A."> <text>The occupational therapist does not need to meet the competency requirements as set forth in this chapter in order to develop a treatment plan which includes recommendations for use of physical agent modalities.</text> </paragraph> <paragraph num="B."> <text>The therapeutic parameters for physical agent modalities shall be established by the occupational therapist or occupational therapy assistant administering the modality.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Documentation of Education in Electrical Physical Agent Modalities."> <paragraph num="A."> <text>The occupational therapist or occupational therapy assistant is responsible for maintaining verification of education relative to electrical physical agent modalities.</text> </paragraph> <paragraph num="B."> <text>Verification shall include:</text> <paragraph num="(1)"> <text>Identification of the specific courses or training where the therapist learned content related to each subject area as specified in Regulation .04B of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Proof of 15 contact hours of didactic education by virtue of a certificate of completion or proof of education, if applicable;</text> </paragraph> <paragraph num="(3)"> <text>An official grade report or official transcript to verify academic education;</text> </paragraph> <paragraph num="(4)"> <text>Written verification from an educator that five client treatments have been completed under direct clinical education for each specific modality; and</text> </paragraph> <paragraph num="(5)"> <text>Additional verification requested by the Board as deemed necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Maintaining Records of Education Documentation."> <paragraph num="A."> <text>A licensee shall retain verification documentation and direct clinical education relative to electrical physical agent modalities for the duration of the licensee's professional career in occupational therapy.</text> </paragraph> <paragraph num="B."> <text>A licensee's submission of any false statement regarding physical agent modality competency requirements shall result in formal disciplinary action by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Superficial Physical Agent Modalities."> <text>A licensee may apply superficial physical agent modalities including, but not limited to, hot packs, cold packs, paraffin, fluidotherapy, and icing.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Audit of Physical Agent Modalities Documentation."> <paragraph num="A."> <text>At the Board's discretion, the Board may audit a number of randomly selected licensees.</text> </paragraph> <paragraph num="B."> <text>The Board shall send notification of audit to audited licensees.</text> </paragraph> <paragraph num="C."> <text>A licensee is subject to an audit of the licensee's physical agent modalities documentation by the Board before renewal of licensure.</text> </paragraph> <paragraph num="D."> <text>An audited licensee shall successfully complete the requirement of the audit by the specified deadline.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §10-101, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective June 1, 2001 (28:12 Md. R. 1102); adopted permanently effective September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 21, 2008 (35:8 Md. R. 805)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 17, 2010 (37:10 Md. R. 722)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 14, 2015 (42:18 Md. R. 1174)</annotation> </annotations> </chapter> <chapter num="07" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter shall be used by the Board and the Maryland Office of Administrative Hearings as a framework for imposing discipline.</text> </paragraph> <paragraph num="B."> <text>The Board and the Maryland Office of Administrative Hearings shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation.</text> </paragraph> <paragraph num="C."> <text>The Board is aware that there may be conduct by a licensee that does not fall squarely within a particular grid contained in Regulation .06 of this chapter. In that event the Board will use its best judgment to determine the appropriate sanction.</text> </paragraph> <paragraph num="D."> <text>The Board and the Maryland Office of Administrative Hearings shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Occupational Therapy Practice.</text> </paragraph> <paragraph num="(2)"> <text>“Conditions” means requirements in a public or non-public order that a licensee is required to satisfy which include but are not limited to:</text> <paragraph num="(a)"> <text>Treatment and counseling for an emotional or physical illness;</text> </paragraph> <paragraph num="(b)"> <text>Submission to drug and alcohol testing;</text> </paragraph> <paragraph num="(c)"> <text>Abstinence from specified drugs;</text> </paragraph> <paragraph num="(d)"> <text>Abstinence from alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Remedial training;</text> </paragraph> <paragraph num="(f)"> <text>Inspection;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring;</text> </paragraph> <paragraph num="(h)"> <text>Evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(j)"> <text>Testing of clinical skills;</text> </paragraph> <paragraph num="(k)"> <text>Submission of written reports;</text> </paragraph> <paragraph num="(l)"> <text>A demonstration of knowledge or competency;</text> </paragraph> <paragraph num="(m)"> <text>Limitation of practice;</text> </paragraph> <paragraph num="(n)"> <text>Limitation on the administration of specified drugs to patients;</text> </paragraph> <paragraph num="(o)"> <text>The provision of pro bono occupational therapy to the poor, elderly, or disabled;</text> </paragraph> <paragraph num="(p)"> <text>Obeyance of Maryland Occupational Therapy Practice Act, federal, state, and local laws; and</text> </paragraph> <paragraph num="(q)"> <text>The payment of a civil penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Conduct” means behavior or action or a failure to behave or act that results in a violation of the Maryland Occupational Therapy Practice Act or the regulations adopted by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees in formal and informal actions and proceedings.</text> </paragraph> <paragraph num="B."> <text>Except as provided in Regulation .05 of this chapter, the Board shall impose a sanction not less severe than the minimum listed in Regulation .06 of this chapter, nor more severe than the maximum listed in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>When conduct results in multiple violations of the Maryland Occupational Therapy Practice Act and the regulations adopted by the Board, the Board shall consider sanctions that are greater than those imposed for a single violation.</text> </paragraph> <paragraph num="D."> <text>This chapter is not applicable to disciplinary matters reviewed by the Board that are initially closed.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise indicated, the period of a suspension may be stayed in whole or in part.</text> </paragraph> <paragraph num="F."> <text>A respondent placed on suspension or probation shall have conditions attached to the suspension or probation which focus on the conduct and steps needed to assure public protection.</text> </paragraph> <paragraph num="G."> <text>Consent orders shall:</text> <paragraph num="(1)"> <text>Include an acknowledgement of the violation or violations; and</text> </paragraph> <paragraph num="(2)"> <text>Indicate that the respondent accepts personal responsibility for the respondent's behavior.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the conduct is not described in Regulation .06 of this chapter, the Board shall use its judgment to determine appropriate sanctions.</text> </paragraph> <paragraph num="I."> <text>A departure from the sanctioning guidelines alone may not be grounds for any hearing or appeal of any Board action before the Board or the Maryland Office of Administrative Hearings.</text> </paragraph> <paragraph num="J."> <text>The sanctioning guidelines are not applicable to:</text> <paragraph num="(1)"> <text>Individuals seeking an initial license; or</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a license under State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Notwithstanding the sanctioning guidelines, a respondent may surrender a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Aggravating and Mitigating Factors."> <paragraph num="A."> <text>Sanctions in a particular case may fall outside the range of the sanctioning guidelines established by the Board.</text> </paragraph> <paragraph num="B."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of the sanctioning guidelines:</text> <paragraph num="(1)"> <text>Aggravating factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative discipline history;</text> </paragraph> <paragraph num="(b)"> <text>Whether the offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>Whether the offense has the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>Whether the offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>Whether the respondent pursued the respondent's financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was especially vulnerable;</text> </paragraph> <paragraph num="(g)"> <text>Whether the respondent attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(h)"> <text>Whether the respondent:</text> <paragraph num="(i)"> <text>Concealed, falsified, or destroyed evidence; or</text> </paragraph> <paragraph num="(ii)"> <text>Presented false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Whether the respondent willfully and without legal justification failed to cooperate with a lawful investigation conducted by the Board; and</text> </paragraph> <paragraph num="(j)"> <text>Whether previous attempts to rehabilitate the respondent were unsuccessful; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mitigating factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The passage of time since any prior offenses;</text> </paragraph> <paragraph num="(c)"> <text>Whether the respondent self-reported to the Board;</text> </paragraph> <paragraph num="(d)"> <text>Cooperation with the Board’s investigation;</text> </paragraph> <paragraph num="(e)"> <text>Full disclosure to the Board;</text> </paragraph> <paragraph num="(f)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(g)"> <text>Timely good-faith efforts to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(i)"> <text>Absence of premeditation to commit the offense;</text> </paragraph> <paragraph num="(j)"> <text>Absence of potential harm to the public;</text> </paragraph> <paragraph num="(k)"> <text>Absence of adverse impact;</text> </paragraph> <paragraph num="(l)"> <text>Whether the offense was an isolated incident and not likely to recur;</text> </paragraph> <paragraph num="(m)"> <text>How and when the respondent has been involved in community service and the value of the community service to the community; and</text> </paragraph> <paragraph num="(n)"> <text>Voluntary admissions of misconduct.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disciplinary Guidelines."> <text>The following guidelines shall be used by the Board as a guide for sanctioning licensees in formal and informal actions and proceedings:</text> <paragraph num="A."> <text>Abuse — Physical and Emotional.</text> </paragraph> <paragraph num="B."> <text>Criminal Convictions or Plea of Nolo Contendere.</text> </paragraph> <paragraph num="C."> <text>Disciplined by Another Licensing or Disciplinary Authority.</text> </paragraph> <paragraph num="D."> <text>Diversion of Controlled Substances or Prescription Drugs.</text> </paragraph> <paragraph num="E."> <text>Failure to Renew a License When the Licensee Has Continued to Practice.</text> </paragraph> <paragraph num="F."> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="G."> <text>Incompetent Practice or Misconduct.</text> </paragraph> <paragraph num="H."> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="I."> <text>Substance Abuse.</text> </paragraph> <paragraph num="J."> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="K."> <text>Unethical Conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606 and 10-315, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 23, 2017 (44:21 Md. R. 984)</annotation> </annotations> </chapter> <chapter num="08" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of occupational therapy or limited occupational therapy using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Occupational Therapy Practice.</text> </paragraph> <paragraph num="(3)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means:</text> <paragraph num="(a)"> <text>A Maryland licensed occupational therapist or limited occupational therapist performing telehealth services within their respective scope of practice; or</text> </paragraph> <paragraph num="(b)"> <text>An occupational therapist or limited occupational therapist with a compact privilege in Maryland performing telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, §10-301, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland or hold a compact privilege when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before providing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license number and type or compact privilege number, if applicable; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of the recommended treatment plan;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the patient’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person occupational therapy practice appointments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>An occupational therapist who practices telehealth shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing a treatment plan through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient based solely on an online questionnaire Administrative History.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a telehealth practitioner who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 797)</annotation> </annotations> </chapter> <chapter num="09" heading="Dry Needling"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the provision of dry needling as an intervention performed by occupational therapists who are certified hand therapists (CHTs).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Occupational Therapy Practice.</text> </paragraph> <paragraph num="(2)"> <text>“Dry needling” means a physical agent modality as defined in COMAR 10.46.06.03, also known as intramuscular manual therapy, that:</text> <paragraph num="(a)"> <text>Involves the insertion of one or more solid needles, a mechanical device, into the muscle and related tissues to effect change in muscle and related tissues of the hand, wrist, elbow, and shoulder;</text> </paragraph> <paragraph num="(b)"> <text>Requires ongoing evaluation, assessment, and re-evaluation of the impairments;</text> </paragraph> <paragraph num="(c)"> <text>Is only utilized in parts of the body with neuromuscular or musculoskeletal links to the impairments; and</text> </paragraph> <paragraph num="(d)"> <text>Is not performed for:</text> <paragraph num="(i)"> <text>The purposes of acupuncture and East Asian medicine as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(ii)"> <text>Any purpose outside the scope of occupational therapy</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Minimum Education and Training Necessary to Perform Dry Needling."> <paragraph num="A."> <text>In order to perform dry needling, an occupational therapist shall be a certified hand therapist in good standing, in addition to having completed at least 52 total hours of further instruction, which includes:</text> <paragraph num="(1)"> <text>A total of at least 27 hours of instruction in the following dry-needling-specific course content areas:</text> <paragraph num="(a)"> <text>Theory and application of dry needling to the hand, wrist, elbow, and shoulder;</text> </paragraph> <paragraph num="(b)"> <text>Dry needling technique to the hand, wrist, elbow, and shoulder;</text> </paragraph> <paragraph num="(c)"> <text>Dry needling indications and contraindications;</text> </paragraph> <paragraph num="(d)"> <text>Infection control, the Occupational Safety and Health Administration’s Bloodborne Pathogen Protocol, and safe handling of needles;</text> </paragraph> <paragraph num="(e)"> <text>Emergency preparedness and response procedures related to complications associated with dry needling; and</text> </paragraph> <paragraph num="(f)"> <text>Appropriate documentation of dry needling; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least 25 hours of practical, hands-on instruction in the application and technique of dry needling, under the supervision of a licensed health care practitioner competent in dry needling procedures who has:</text> <paragraph num="(a)"> <text>Completed the requisite course work under §A(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Practiced dry needling for at least 5 years.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The instruction required under §A(1) of this regulation shall be provided by a continuing education course approved by the Board.</text> </paragraph> <paragraph num="C."> <text>All instruction required under this regulation shall include an assessment of competency.</text> </paragraph> <paragraph num="D."> <text>The instruction required under §A(1) of this regulation shall be offered:</text> <paragraph num="(1)"> <text>In person at a face-to-face session; or</text> </paragraph> <paragraph num="(2)"> <text>In real time through electronic means that allow for simultaneous interaction between the instructor and the participants.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An occupational therapist may not fulfill any portion of the practical, hands-on instruction required under §A(2) of this regulation with online or distance learning.</text> </paragraph> <paragraph num="F."> <text>An occupational therapist shall have practiced occupational therapy for at least 2 years, in addition to having been certified as a hand therapist, before performing dry needling in the State.</text> </paragraph> <paragraph num="G."> <text>Registration.</text> <paragraph num="(1)"> <text>An occupational therapist shall be registered with the Board as having the appropriate education and training required by this regulation to be approved to practice dry needling.</text> </paragraph> <paragraph num="(2)"> <text>In order to be registered to practice dry needling, an occupational therapist shall submit a completed application on a form supplied by the Board with proof of the hand therapist certification.</text> </paragraph> <paragraph num="(3)"> <text>In order to continue to practice dry needling, an approved occupational therapist shall submit proof of their certified hand therapy recertification.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An occupational therapist who practices dry needling without the education and training required by this regulation shall be subject to discipline pursuant to COMAR 10.46.07.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice in Performing Dry Needling."> <paragraph num="A."> <text>An occupational therapist shall:</text> <paragraph num="(1)"> <text>Fully explain dry needling to the patient in advance of treatment; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain written informed consent specific to dry needling that shall be included in the patient’s medical record.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An occupational therapist shall perform dry needling to the hand, wrist, elbow, and shoulder in a manner consistent with standards set forth in the Maryland Occupational Safety and Health Act, Labor and Employment Article, Title 5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>An occupational therapist shall document the provision of dry needling services in accordance with the documentation requirements set forth under COMAR 10.46.01.03.</text> </paragraph> <paragraph num="D."> <text>An occupational therapist who practices dry needling in a manner inconsistent with the standards of practice enumerated in this regulation shall be subject to discipline pursuant to COMAR 10.46.07.</text> </paragraph> <paragraph num="E."> <text>Dry needling is not within the scope of practice of limited occupational therapy and shall only be performed by a licensed occupational therapist with a hand therapy certification.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§10-101 and 10-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 16, 2024 (51:18 Md. R. 810)</annotation> </annotations> </chapter> </subtitle> <subtitle num="47" heading="Alcohol and Drug Abuse Administration"> <chapter num="01" heading="Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the requirements for certification of drug and alcohol treatment programs.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Addiction Severity Index” means a standardized method for the assessment of adults regarding addictions severity and patient need.</text> </paragraph> <paragraph num="(2)"> <text>“Administration” means the Alcohol and Drug Abuse Administration within the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Administrator” means the program director of an alcohol or drug abuse facility or a health care facility.</text> </paragraph> <paragraph num="(4)"> <text>“Admission” means the documented acceptance of an applicant into a program.</text> </paragraph> <paragraph num="(5)"> <text>“Adolescent” means an individual 12 — 17 years old.</text> </paragraph> <paragraph num="(6)"> <text>“Alcohol abuse” means a disease that is characterized by a pattern of pathological use of alcohol with repeated attempts to control its use, and with significant negative consequences in at least one of the following areas of life: medical, legal, financial, or psychosocial.</text> </paragraph> <paragraph num="(7)"> <text>“Alcohol dependence” means a disease characterized by:</text> <paragraph num="(a)"> <text>Alcohol abuse; and</text> </paragraph> <paragraph num="(b)"> <text>Physical symptoms of withdrawal or tolerance.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“American Society of Addiction Medicine Patient Placement Criteria” means an instrument designed to indicate patient placement guidelines for admission, continued stay, and discharge.</text> </paragraph> <paragraph num="(9)"> <text>“Assessment” means the process of ascertaining the treatment needs of the patient regarding addiction and other social issues.</text> </paragraph> <paragraph num="(10)"> <text>“Caseload” means the number of patients for whom a drug and alcohol counselor has the responsibility for providing clinical services and case management.</text> </paragraph> <paragraph num="(11)"> <text>“Case management” means the process of coordinating and monitoring the services provided to a patient both within the program and in conjunction with other providers.</text> </paragraph> <paragraph num="(12)"> <text>“Certification” means the approval issued to a program by the Administration to provide services under this subtitle.</text> </paragraph> <paragraph num="(13)"> <text>“Child” means an individual younger than 12 years old.</text> </paragraph> <paragraph num="(14)"> <text>“Clinical director” means the individual who is responsible for the therapeutic and rehabilitative aspects and direction of a program.</text> </paragraph> <paragraph num="(15)"> <text>“Clinical staff” means the individuals employed by or associated with a program who provide treatment, care, or rehabilitation to program patients or patients' families.</text> </paragraph> <paragraph num="(16)"> <text>“Clinical supervisor” means the individual responsible for providing supervision to alcohol and drug clinical staff as clinically appropriate.</text> </paragraph> <paragraph num="(17)"> <text>“Continuous quality review” means objective and systematic monitoring and evaluation of the quality and appropriateness of patient care, the purpose of which is the improvement of that care, prevention of problems, and resolution of problems.</text> </paragraph> <paragraph num="(18)"> <text>“Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I — V under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19)"> <text>Correctional Facility.</text> <paragraph num="(a)"> <text>“Correctional facility” means an institution overseen by the State or one of the 24 subdivisions where individuals are incarcerated.</text> </paragraph> <paragraph num="(b)"> <text>“Correctional facility” includes a jail, detention center, prison, or correctional halfway house.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Credentialing” means a process of review to determine the professional level at which an employee may practice.</text> </paragraph> <paragraph num="(21)"> <text>“Crisis intervention training” means training of staff to respond adequately to emergency situations, including:</text> <paragraph num="(a)"> <text>Medical emergencies;</text> </paragraph> <paragraph num="(b)"> <text>Emotional and psychological crises; and</text> </paragraph> <paragraph num="(c)"> <text>Emergencies arising from environmental circumstances such as fires, floods, terrorism, and other disasters.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>Critical Incident.</text> <paragraph num="(a)"> <text>“Critical incident” means a life, safety, or health threat involving the staff or patients participating in a program.</text> </paragraph> <paragraph num="(b)"> <text>“Critical incident” includes, but is not limited to, death or physical or sexual assault.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Critical incident report” means the documentation of a critical incident.</text> </paragraph> <paragraph num="(24)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(25)"> <text>“Detoxification” means the process of withdrawing addictive psychoactive substances from the body in a safe and effective manner.</text> </paragraph> <paragraph num="(26)"> <text>“Director” means the Director of the Administration.</text> </paragraph> <paragraph num="(27)"> <text>“Discharge plan” means a written description of specific goals and objectives to assist the patient upon leaving treatment.</text> </paragraph> <paragraph num="(28)"> <text>Dispense.</text> <paragraph num="(a)"> <text>“Dispense” means to deliver a controlled dangerous substance or other drug to the ultimate user by a practitioner pursuant to a lawful order of the practitioner.</text> </paragraph> <paragraph num="(b)"> <text>“Dispense” includes prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for delivery.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Documentation” means written or recorded information that is dated.</text> </paragraph> <paragraph num="(30)"> <text>“Drug” means:</text> <paragraph num="(a)"> <text>A controlled dangerous substance that is regulated under the Maryland Controlled Dangerous Substances Act;</text> </paragraph> <paragraph num="(b)"> <text>A prescription medication; or</text> </paragraph> <paragraph num="(c)"> <text>A chemical substance when used for unintended and harmful purposes.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Drug abuse” means a disease which is characterized by a pattern of pathological use of a drug with repeated attempts to control its use, and with significant negative consequences in at least one of the following areas of life: medical, legal, financial, or psychosocial.</text> </paragraph> <paragraph num="(32)"> <text>“Drug dependence” means a disease characterized by:</text> <paragraph num="(a)"> <text>Drug abuse; and</text> </paragraph> <paragraph num="(b)"> <text>Physical symptoms of withdrawal or tolerance.</text> </paragraph> </paragraph> <paragraph num="(33)"> <text>“Family” means an individual's immediate relatives or significant others.</text> </paragraph> <paragraph num="(34)"> <text>“Family counseling” means a distinct discipline that utilizes accepted family system theories and intervention techniques.</text> </paragraph> <paragraph num="(35)"> <text>“Governing body” means the organizational structure that is responsible for establishing policy, maintaining quality care, and providing management and planning for the program.</text> </paragraph> <paragraph num="(36)"> <text>“Individualized treatment plan” means a written plan of action that is developed and modified to address a patient's specific service needs.</text> </paragraph> <paragraph num="(37)"> <text>“Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting.</text> </paragraph> <paragraph num="(38)"> <text>“Maintenance” means medically supervised continuation of the administration of methadone, LAAM, or other drugs approved by the Administration.</text> </paragraph> <paragraph num="(39)"> <text>“Medical director” means a physician who oversees the medical practice of a program.</text> </paragraph> <paragraph num="(40)"> <text>“Methadone” means a synthetic opioid.</text> </paragraph> <paragraph num="(41)"> <text>“Nurse” means an individual who is licensed by the State Board of Nursing to practice registered nursing or licensed practical nursing as defined in Health Occupations Article, §8-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(42)"> <text>“Nurse practitioner” means a registered nurse who is certified as a nurse practitioner as defined in Health Occupations Article, §8-508, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(43)"> <text>“Office of Health Care Quality” means the office under the Department that oversees certification and inspection of programs for the Administration.</text> </paragraph> <paragraph num="(44)"> <text>“Patient” means an individual who is admitted into a program.</text> </paragraph> <paragraph num="(45)"> <text>“Physician” means any person authorized by law to practice medicine in this State under Health Occupations Article, §14-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(46)"> <text>“Physician assistant” means an individual licensed to act as an assistant to a licensed physician in Maryland, as defined in Health Occupations Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(47)"> <text>“Possess” means the exercise of actual or constructive dominion or control over a controlled dangerous substance.</text> </paragraph> <paragraph num="(48)"> <text>“Prevention program” means the Early Intervention Level 0.5 level of treatment as described in COMAR 10.47.02.03.</text> </paragraph> <paragraph num="(49)"> <text>“Privileging” means the process of review to determine the duties a volunteer or employee may perform.</text> </paragraph> <paragraph num="(50)"> <text>“Problem Oriented Screening Instrument for Teenagers” means a standardized method of screening to determine whether or not an adolescent may have alcohol or other drug abuse or dependence or both and will need further evaluation.</text> </paragraph> <paragraph num="(51)"> <text>Program.</text> <paragraph num="(a)"> <text>“Program” means any organization or individual that provides treatment, care, or rehabilitation for individuals who show the effects of drug abuse or alcohol abuse, and represents or advertises itself as an alcohol or other drug abuse treatment program.</text> </paragraph> <paragraph num="(b)"> <text>“Program” includes a:</text> <paragraph num="(i)"> <text>Program or facility that is owned or operated by the State or any of its political subdivisions; and</text> </paragraph> <paragraph num="(ii)"> <text>Detoxification facility as defined in Health-General Article, §8-101(g), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(52)"> <text>“Progress note” means an objective documentation of the patient's progress in relation to specific treatment goals and objectives.</text> </paragraph> <paragraph num="(53)"> <text>“Screening” means the utilization of a valid tool or instrument approved by the Administration to determine whether or not an individual may have alcohol or other drug abuse or dependence or both and will need further evaluation.</text> </paragraph> <paragraph num="(54)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(55)"> <text>“Self-help group” means a voluntary fellowship or group that supports patients in recovery from alcohol and other drug abuse or dependence.</text> </paragraph> <paragraph num="(56)"> <text>“Therapeutic agent” means an intervention that is used to effect positive change.</text> </paragraph> <paragraph num="(57)"> <text>“Treatment plan goal” means an intended resolution of a patient's clinical condition or problem that is completed within a specific amount of time and will contribute to the completion of treatment in a program.</text> </paragraph> <paragraph num="(58)"> <text>“Treatment plan objective” means a behaviorally measurable symptom or social, legal, or family change that results in a stepwise achievement of a treatment goal.</text> </paragraph> <paragraph num="(59)"> <text>“Utilization review” means a systematic assessment of the appropriateness of patient admissions, continuation in treatment, and referral to specific treatment services within a program.</text> </paragraph> <paragraph num="(60)"> <text>“Variance” means an alternate method of meeting the intent of a regulation under this subtitle.</text> </paragraph> <paragraph num="(61)"> <text>“Waiting list” means a list of individuals who are appropriate for services from a program but for whom a treatment slot is not available for 4 or more weeks for outpatient programs, or 2 or more weeks for residential programs.</text> </paragraph> <paragraph num="(62)"> <text>“Waiver” means the exemption from compliance with a regulation under this subtitle.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Governance."> <paragraph num="A."> <text>The program shall:</text> <paragraph num="(1)"> <text>Have a governing body legally responsible for overseeing the management and operation of the program and for ensuring compliance with applicable laws and regulations by:</text> <paragraph num="(a)"> <text>Approving the program's:</text> <paragraph num="(i)"> <text>Mission;</text> </paragraph> <paragraph num="(ii)"> <text>Goals;</text> </paragraph> <paragraph num="(iii)"> <text>Policies and procedures;</text> </paragraph> <paragraph num="(iv)"> <text>Budget; and</text> </paragraph> <paragraph num="(v)"> <text>Program service plan;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Adopting written bylaws;</text> </paragraph> <paragraph num="(c)"> <text>Overseeing the operation of the program, according to the stated purposes of the program;</text> </paragraph> <paragraph num="(d)"> <text>Ensuring proper management of the program by developing a job description for the administrator, and hiring, supervising, and providing for periodic performance evaluation of the administrator; and</text> </paragraph> <paragraph num="(e)"> <text>Ensuring sound fiscal operation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Implement fiscal policies and procedure which include:</text> <paragraph num="(a)"> <text>The maintenance of fiscal records according to generally accepted accounting principles in Article 19, §28A, Annotated Code of Maryland, and COMAR 10.02.01 and 10.04.04;</text> </paragraph> <paragraph num="(b)"> <text>Appropriate fire, casualty, liability, unemployment, and workers' compensation insurance;</text> </paragraph> <paragraph num="(c)"> <text>In the event of fiscal instability, immediately notifying the Office of Health Care Quality;</text> </paragraph> <paragraph num="(d)"> <text>Maintaining and posting a list of services and associated charges; and</text> </paragraph> <paragraph num="(e)"> <text>Maintaining an annual program budget reflecting anticipated expenditures and sources of income;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Implement personnel policies and procedures that include:</text> <paragraph num="(a)"> <text>Personnel policies and procedures that promote the objectives of the program;</text> </paragraph> <paragraph num="(b)"> <text>Personnel policies that include:</text> <paragraph num="(i)"> <text>The qualifications required for each position;</text> </paragraph> <paragraph num="(ii)"> <text>An employee assistance policy and procedure;</text> </paragraph> <paragraph num="(iii)"> <text>A policy to prevent discrimination prohibited by Article 49B, Annotated Code of Maryland, and federal law;</text> </paragraph> <paragraph num="(iv)"> <text>A policy designed to prevent sexual harassment of staff and patients and appropriately manage complaints of sexual harassment;</text> </paragraph> <paragraph num="(v)"> <text>A staff grievance procedure;</text> </paragraph> <paragraph num="(vi)"> <text>A mechanism for assuring annual employee tuberculosis testing;</text> </paragraph> <paragraph num="(vii)"> <text>Before employment, applying for national and State criminal history records checks;</text> </paragraph> <paragraph num="(viii)"> <text>As part of the employment or volunteer application process, requiring the applicant to complete and sign a sworn statement or written affirmation disclosing the existence of a criminal conviction, probation before judgment disposition, not criminally responsible disposition, or pending charges without a final disposition;</text> </paragraph> <paragraph num="(ix)"> <text>Requiring the employee to comply with §A(3)(b)(viii) of this regulation annually; and</text> </paragraph> <paragraph num="(x)"> <text>Providing information to the employee so the employee may determine whether he or she needs testing or vaccination or both for hepatitis;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintaining a personnel file, in accordance with State and federal confidentiality requirements, for each employee, contractual staff, intern, or volunteer, that includes the individual’s:</text> <paragraph num="(i)"> <text>Written application or resume including, name, home address, current telephone number, educational and training background, and employment history;</text> </paragraph> <paragraph num="(ii)"> <text>Emergency contact information;</text> </paragraph> <paragraph num="(iii)"> <text>Copies of required credentials;</text> </paragraph> <paragraph num="(iv)"> <text>Current job title and description;</text> </paragraph> <paragraph num="(v)"> <text>Current wage and salary information;</text> </paragraph> <paragraph num="(vi)"> <text>Annual performance evaluation;</text> </paragraph> <paragraph num="(vii)"> <text>Contracts, if applicable;</text> </paragraph> <paragraph num="(viii)"> <text>Results of a criminal background check;</text> </paragraph> <paragraph num="(ix)"> <text>Results of tuberculosis tests; and</text> </paragraph> <paragraph num="(x)"> <text>Documentation of attendance at continuing education courses or other training; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Not permitting any individual with a documented history of physical, mental, or sexual abuse or neglect of adolescents or children to work with children and adolescents;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Manage the program by:</text> <paragraph num="(a)"> <text>Implementing a policy and procedure manual that contains:</text> <paragraph num="(i)"> <text>An all hazards emergency protocol plan, approved by the Administration and updated at the time of recertification, that includes the name of the contact person for access to medical and clinical records, the written agreement or agreements with another facility to provide services in case of an emergency, notification procedures for the State Methadone Authority, program staff, and patients, a policy regarding patient access to emergency mental health services necessitated by a hazardous event, and a policy assuring that correctional levels of care comply with the institution’s all hazards emergency plan;</text> </paragraph> <paragraph num="(ii)"> <text>The program's mission and goals;</text> </paragraph> <paragraph num="(iii)"> <text>A description of the organizational structure of the program;</text> </paragraph> <paragraph num="(iv)"> <text>Identification of the duties of the administrator and, if applicable, the medical director or clinical director;</text> </paragraph> <paragraph num="(v)"> <text>Admission, transition, discharge, and termination procedures;</text> </paragraph> <paragraph num="(vi)"> <text>Procedures governing patient rights and grievances;</text> </paragraph> <paragraph num="(vii)"> <text>If applicable, a procedure for storing, handling, prescribing, dispensing, administering, and disposing of medications;</text> </paragraph> <paragraph num="(viii)"> <text>Procedures for assisting program enrollees with access to entitlements, insurance benefits, and reimbursements for which the individual is eligible, if the program provides case management services; and</text> </paragraph> <paragraph num="(ix)"> <text>Procedures for staff orientation, supervision, training, and education that include, but are not limited to, ethics and State and federal laws regarding confidentiality including, but not limited to, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, 42 CFR Part 2, The Health Insurance Portability Assurance and Accountability Act (HIPAA), and 45 CFR Parts 160 and 164; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Implementing a program service plan, approved by the Administration, that is based on the levels of treatment to be provided as defined in COMAR 10.47.02.03 — .11 and describes how the program shall comply with the regulatory requirements, is updated annually, and includes:</text> <paragraph num="(i)"> <text>A description of medical staff, if required by the level of treatment;</text> </paragraph> <paragraph num="(ii)"> <text>A description of the program's scope that includes target populations and other program characteristics;</text> </paragraph> <paragraph num="(iii)"> <text>Staff positions, their job descriptions, and educational and clinical training requirements, including an organizational chart detailing lines of authority and responsibility;</text> </paragraph> <paragraph num="(iv)"> <text>A list of services to be delivered, including the types of medication and controlled dangerous substances to be prescribed, the types of group sessions, including education, the types of individual sessions and a complete family services plan;</text> </paragraph> <paragraph num="(v)"> <text>Names of clinical supervisors and the number of alcohol and drug counselors supervised;</text> </paragraph> <paragraph num="(vi)"> <text>Types of services that are available by referral; and</text> </paragraph> <paragraph num="(vii)"> <text>Planning protocol for transfer or discharge of patients;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Implement a continuous quality review process that includes:</text> <paragraph num="(a)"> <text>Designated teams responsible for implementation;</text> </paragraph> <paragraph num="(b)"> <text>An ongoing procedure for utilization review;</text> </paragraph> <paragraph num="(c)"> <text>A plan to identify problems and initiate actions to correct deviations from the program’s established standards, which includes:</text> <paragraph num="(i)"> <text>Data collection;</text> </paragraph> <paragraph num="(ii)"> <text>Current information regarding efficient and effective service delivery;</text> </paragraph> <paragraph num="(iii)"> <text>Indicators relevant to the needs of the population served; and</text> </paragraph> <paragraph num="(iv)"> <text>Ongoing internal review of the program, including monitoring for effectiveness of changes incorporated; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>An opportunity for all staff to participate on the teams described in §E of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Report critical incidents to the Administration within 5 business days of the incident;</text> </paragraph> <paragraph num="(7)"> <text>Limit an individual’s role on the governing body to being a nonvoting member if the individual has an immediate family member who:</text> <paragraph num="(a)"> <text>Is employed by the program;</text> </paragraph> <paragraph num="(b)"> <text>Consults on behalf of the program;</text> </paragraph> <paragraph num="(c)"> <text>Owns the program; or</text> </paragraph> <paragraph num="(d)"> <text>Sits on an advisory committee for the program; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Refuse to allow an individual to serve on the program’s governing body if the individual receives any monetary benefit from the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program may not allow:</text> <paragraph num="(1)"> <text>An immediate family member of an employee of an organization to serve as a voting member of the governing body, board of directors, or advisory committee; or</text> </paragraph> <paragraph num="(2)"> <text>An individual who is compensated for providing goods or services to the program to serve on the governing body, board of directors, or advisory committee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Clinical Requirements."> <paragraph num="A."> <text>Admission. The program:</text> <paragraph num="(1)"> <text>Shall upon request for admission:</text> <paragraph num="(a)"> <text>Establish an interview date that falls within 10 working days of the individual's initial contact;</text> </paragraph> <paragraph num="(b)"> <text>Refer or recommend another program to the individual; or</text> </paragraph> <paragraph num="(c)"> <text>Place the individual on a waiting list;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall have a detailed description of patient placement criteria for admission to the program, including:</text> <paragraph num="(a)"> <text>Eligibility criteria, using guidelines such as the American Society of Addiction Medicine Patient Placement Criteria or other guidelines approved by the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Procedures for admission;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Shall include in its admission procedures:</text> <paragraph num="(a)"> <text>An intake process;</text> </paragraph> <paragraph num="(b)"> <text>An emergency intake process, including a procedure to refer individuals who are not suitable for its program to a more suitable program;</text> </paragraph> <paragraph num="(c)"> <text>A procedure for developing and maintaining a waiting list; and</text> </paragraph> <paragraph num="(d)"> <text>A fee schedule; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>May not admit a patient unless the individual meets the admission criteria of the American Society of Addiction Medicine Patient Placement Criteria or other guidelines approved by the Administration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Assessment.</text> <paragraph num="(1)"> <text>A program shall prepare a comprehensive assessment for each patient, unless the patient is being readmitted to the same program or admitted to a different program within 30 days of the patient's last discharge, or has received an assessment by a licensed or certified clinician or program within 30 days, in which case the program may update the prior assessment.</text> </paragraph> <paragraph num="(2)"> <text>The comprehensive assessment shall assess the following areas:</text> <paragraph num="(a)"> <text>Physical health;</text> </paragraph> <paragraph num="(b)"> <text>Employment or financial support;</text> </paragraph> <paragraph num="(c)"> <text>Drug and alcohol;</text> </paragraph> <paragraph num="(d)"> <text>Treatment history;</text> </paragraph> <paragraph num="(e)"> <text>Legal;</text> </paragraph> <paragraph num="(f)"> <text>Family and social;</text> </paragraph> <paragraph num="(g)"> <text>Educational; and</text> </paragraph> <paragraph num="(h)"> <text>Mental health.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Programs shall use the Addiction Severity Index as the standardized assessment instrument for adults, or an equivalent assessment instrument chosen by the Administration.</text> </paragraph> <paragraph num="(4)"> <text>Programs shall use the Problem Oriented Screening Instrument for Teenagers as the standardized screening instrument for adolescents, or an equivalent screening instrument chosen by the Administration.</text> </paragraph> <paragraph num="(5)"> <text>The initial physical health assessment shall meet the requirements of the appropriate level of treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Treatment Plans.</text> <paragraph num="(1)"> <text>A program shall develop a written treatment plan, with the participation of the patient, based on the comprehensive assessment and patient placement criteria, that shall set forth:</text> <paragraph num="(a)"> <text>The patient's individualized needs, including:</text> <paragraph num="(i)"> <text>Socialization;</text> </paragraph> <paragraph num="(ii)"> <text>Alcohol and drug abuse or dependence;</text> </paragraph> <paragraph num="(iii)"> <text>Psychological;</text> </paragraph> <paragraph num="(iv)"> <text>Vocational;</text> </paragraph> <paragraph num="(v)"> <text>Educational;</text> </paragraph> <paragraph num="(vi)"> <text>Physical health;</text> </paragraph> <paragraph num="(vii)"> <text>Legal; and</text> </paragraph> <paragraph num="(viii)"> <text>Family; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Individualized interventions, including:</text> <paragraph num="(i)"> <text>Long-range and short-range treatment plan goals and objectives;</text> </paragraph> <paragraph num="(ii)"> <text>Strategy for implementation of treatment plan goals and objectives;</text> </paragraph> <paragraph num="(iii)"> <text>Target dates for completion of treatment plan goals and objectives;</text> </paragraph> <paragraph num="(iv)"> <text>A schedule of clinical services including individual, group, and, if appropriate, family counseling;</text> </paragraph> <paragraph num="(v)"> <text>Criteria for successful completion of treatment;</text> </paragraph> <paragraph num="(vi)"> <text>Referrals to ancillary services, if needed; and</text> </paragraph> <paragraph num="(vii)"> <text>Referrals to self-help groups, if recommended.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the alcohol and other drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(a)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(b)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(c)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director's or clinical supervisor's documentation of the delay.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The length of stay in the program shall be based on the patient's level of illness severity and response to treatment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Infectious Disease Education. Within the first 30 days of treatment, a program shall ensure and document in the patient record that human immunodeficiency virus, hepatitis, sexually transmitted diseases, and tuberculosis education was completed, including:</text> <paragraph num="(1)"> <text>Risk assessment;</text> </paragraph> <paragraph num="(2)"> <text>Risk reduction; and</text> </paragraph> <paragraph num="(3)"> <text>If appropriate, referral for counseling and testing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Family Involvement and Utilization of Self-Help Groups.</text> <paragraph num="(1)"> <text>A program may provide education and support services to a patient's family directly or through referrals to appropriate community agencies.</text> </paragraph> <paragraph num="(2)"> <text>A program shall:</text> <paragraph num="(a)"> <text>Develop procedures for obtaining an assessment of the treatment needs of the patient's family;</text> </paragraph> <paragraph num="(b)"> <text>Provide access or referral to family counseling;</text> </paragraph> <paragraph num="(c)"> <text>Describe how family members are involved in the patient's recovery process; and</text> </paragraph> <paragraph num="(d)"> <text>Develop procedures to encourage ongoing active participation by the patient and the patient's family in self-help groups and support activities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Referrals. Referral documentation shall include the:</text> <paragraph num="(1)"> <text>Reason for referral;</text> </paragraph> <paragraph num="(2)"> <text>Name of the individual;</text> </paragraph> <paragraph num="(3)"> <text>Referring program;</text> </paragraph> <paragraph num="(4)"> <text>Receiving program; and</text> </paragraph> <paragraph num="(5)"> <text>Final disposition of referral.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Discharge.</text> <paragraph num="(1)"> <text>A program shall complete a written discharge summary.</text> </paragraph> <paragraph num="(2)"> <text>The discharge summary shall include:</text> <paragraph num="(a)"> <text>The reason for admission;</text> </paragraph> <paragraph num="(b)"> <text>The reason for discharge;</text> </paragraph> <paragraph num="(c)"> <text>The individual's address;</text> </paragraph> <paragraph num="(d)"> <text>A summary of services delivered, including frequency and duration of services, and progress made;</text> </paragraph> <paragraph num="(e)"> <text>If appropriate, the diagnosis and prognosis at the time of discharge;</text> </paragraph> <paragraph num="(f)"> <text>Current medications, if applicable;</text> </paragraph> <paragraph num="(g)"> <text>Continuing service recommendations and summary of transition process; and</text> </paragraph> <paragraph num="(h)"> <text>The extent of the individual's involvement in the discharge plan.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The discharge summary shall be completed within 30 days of the patient's discharge from the program.</text> </paragraph> <paragraph num="(4)"> <text>In the event of a patient's transfer from the program to another program, the discharging program shall complete a written transfer summary.</text> </paragraph> <paragraph num="(5)"> <text>The transfer summary shall include:</text> <paragraph num="(a)"> <text>The reason for admission;</text> </paragraph> <paragraph num="(b)"> <text>The reason for discharge;</text> </paragraph> <paragraph num="(c)"> <text>The individual's address;</text> </paragraph> <paragraph num="(d)"> <text>The diagnosis and prognosis at the time of discharge; and</text> </paragraph> <paragraph num="(e)"> <text>Current medications, if applicable.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The transfer summary shall be completed at the time of the patient's discharge from the program.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Child and Adolescent Services.</text> <paragraph num="(1)"> <text>A parent or guardian of a child or adolescent, with the child or adolescent's consent, may apply on behalf of the child or adolescent for admission to a certified program.</text> </paragraph> <paragraph num="(2)"> <text>A program exclusively for children and adolescents shall:</text> <paragraph num="(a)"> <text>Maintain written treatment protocols providing for the needs of adolescents and children, emphasizing the use of family interventions;</text> </paragraph> <paragraph num="(b)"> <text>Provide for the educational needs of adolescents in compliance with local, State, and federal laws and regulations;</text> </paragraph> <paragraph num="(c)"> <text>Comply with criminal background requirements for all staff; and</text> </paragraph> <paragraph num="(d)"> <text>Meet any other requirements requested by the Administration.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A program that admits children and adolescents:</text> <paragraph num="(a)"> <text>May not admit a child or adolescent into treatment unless the treatment plan indicates that the program is appropriate for the child or adolescent;</text> </paragraph> <paragraph num="(b)"> <text>Shall provide separate social, residential, dietary, and recreational activities for the child or adolescent, if appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Shall obtain informed consent from the child or adolescent, or the parents or guardians for the child or adolescent, to be admitted to the program;</text> </paragraph> <paragraph num="(d)"> <text>Shall comply with criminal background requirements for all staff; and</text> </paragraph> <paragraph num="(e)"> <text>Shall meet any other requirements requested by the Administration.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A program that does not admit children and adolescents shall:</text> <paragraph num="(a)"> <text>Identify in its program service plan the elements of the program that make treatment, care, and rehabilitation for children or adolescents contraindicated; and</text> </paragraph> <paragraph num="(b)"> <text>Meet any other requirements requested by the Administration.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Programs that provide services to adults and permit the adult's children or adolescents to be present at the program shall verify that the children and adolescents:</text> <paragraph num="(a)"> <text>Receive proper supervision;</text> </paragraph> <paragraph num="(b)"> <text>Are appropriately enrolled in education services; and</text> </paragraph> <paragraph num="(c)"> <text>Have access to appropriate health care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Medication Control and Staff Requirements.</text> <paragraph num="(1)"> <text>A program shall develop and implement a written policy and procedure governing the use of controlled dangerous substances and other drugs used by the program. The policies shall include:</text> <paragraph num="(a)"> <text>A list of controlled dangerous substances and other drugs administered, dispensed, or stored at the program;</text> </paragraph> <paragraph num="(b)"> <text>Procedures to account for and secure the drugs from time of order until dispensing;</text> </paragraph> <paragraph num="(c)"> <text>Computer security and accountability, if applicable;</text> </paragraph> <paragraph num="(d)"> <text>Other policy and procedures required by the Administration; and</text> </paragraph> <paragraph num="(e)"> <text>Procedures for all Level III programs to hold securely all take-home opioid therapy medication for patients who are on opioid maintenance therapy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program shall dispense medications to the patient according to the instructions, supervision, and directions of the licensed physician.</text> </paragraph> <paragraph num="(3)"> <text>If staff observes an adverse reaction to medication, the program immediately shall contact a licensed physician or emergency medical service to ensure the patient receives treatment.</text> </paragraph> <paragraph num="(4)"> <text>Medication Errors.</text> <paragraph num="(a)"> <text>For a medication error regarding administration, dispensing, documentation, inventory, or storage, an appropriate clinical staff person shall complete a report at the time of the incident.</text> </paragraph> <paragraph num="(b)"> <text>The report shall be filed and brought to the immediate attention of the:</text> <paragraph num="(i)"> <text>Administrator; and</text> </paragraph> <paragraph num="(ii)"> <text>Medical director, if a medical director is employed by the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Programs shall report the diversion of any controlled substance to the Administration as soon as the diversion is discovered.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Environmental Requirements."> <paragraph num="A."> <text>Life Safety Requirements. A program shall:</text> <paragraph num="(1)"> <text>Have a facility free from fire hazards and have:</text> <paragraph num="(a)"> <text>Adequate smoke detectors;</text> </paragraph> <paragraph num="(b)"> <text>Working and updated fire extinguishers;</text> </paragraph> <paragraph num="(c)"> <text>A written fire evacuation plan; and</text> </paragraph> <paragraph num="(d)"> <text>A current fire inspection certification;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Comply with applicable federal, State, and local sanitation, building, fire codes, and zoning requirements;</text> </paragraph> <paragraph num="(3)"> <text>Maintain documentation of legally required periodic evacuation drills, if applicable; and</text> </paragraph> <paragraph num="(4)"> <text>Within the first 30 days of employment, provide staff training in emergency evacuation procedures.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Special Accommodations. A program shall have protocols, which may include referral agreements with other programs, that provide for admission and treatment of individuals with:</text> <paragraph num="(1)"> <text>Limited English proficiency or hearing and speaking disabilities; and</text> </paragraph> <paragraph num="(2)"> <text>Physical and mental disabilities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Residential Treatment Programs. A program shall have:</text> <paragraph num="(1)"> <text>Nurses' stations, if appropriate;</text> </paragraph> <paragraph num="(2)"> <text>A dining room;</text> </paragraph> <paragraph num="(3)"> <text>Bathrooms;</text> </paragraph> <paragraph num="(4)"> <text>Telephones;</text> </paragraph> <paragraph num="(5)"> <text>A living room;</text> </paragraph> <paragraph num="(6)"> <text>Space for privacy for visits;</text> </paragraph> <paragraph num="(7)"> <text>Space for leisure time activities;</text> </paragraph> <paragraph num="(8)"> <text>Offices for both administrative and counseling personnel; and</text> </paragraph> <paragraph num="(9)"> <text>Sleeping quarters that:</text> <paragraph num="(a)"> <text>Do not allow for more than six patients to share the sleeping quarters, except for therapeutic communities that use dormitory style sleeping areas;</text> </paragraph> <paragraph num="(b)"> <text>Provide adolescents and adults with separate sleeping quarters;</text> </paragraph> <paragraph num="(c)"> <text>Provide privacy for patients;</text> </paragraph> <paragraph num="(d)"> <text>Provide beds that:</text> <paragraph num="(i)"> <text>Are at least 3 feet apart;</text> </paragraph> <paragraph num="(ii)"> <text>Are located more than 18 inches away from radiators and registers;</text> </paragraph> <paragraph num="(iii)"> <text>Are at least 36 inches wide, and not rollaway-type beds, cots, or folding beds;</text> </paragraph> <paragraph num="(iv)"> <text>Have mattresses that are clean, in good repair, and the same size as the bed frame; and</text> </paragraph> <paragraph num="(v)"> <text>Have at least two sets of sheets;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Have at least two dresser drawers and an enclosed space for hanging clothes; and</text> </paragraph> <paragraph num="(f)"> <text>Have a mirror and window coverings in good repair;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>A method for safely storing a patient's valuables; and</text> </paragraph> <paragraph num="(11)"> <text>A written plan for providing temporary shelter for patients if a facility becomes uninhabitable.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Dietary Services. If meals are provided, a program shall:</text> <paragraph num="(1)"> <text>Comply with applicable local, State, and federal laws;</text> </paragraph> <paragraph num="(2)"> <text>Have a written plan describing the organization and delivery of dietary services; and</text> </paragraph> <paragraph num="(3)"> <text>Require a dietitian licensed under the Health Occupations Article, §5-101, Annotated Code of Maryland, to develop and implement the dietary service plan.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Infection Control — Universal Precautions. A program shall observe universal precautions as required under COMAR 10.07.02.21-1.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Staff Requirements."> <paragraph num="A."> <text>Administrator.</text> <paragraph num="(1)"> <text>A program shall have an administrator.</text> </paragraph> <paragraph num="(2)"> <text>Qualifications. The administrator shall:</text> <paragraph num="(a)"> <text>Possess a working knowledge of all applicable State and federal laws;</text> </paragraph> <paragraph num="(b)"> <text>Possess a working knowledge of program management skills;</text> </paragraph> <paragraph num="(c)"> <text>Be employed as an administrator before October 1, 2002; or</text> </paragraph> <paragraph num="(d)"> <text>Have at a minimum:</text> <paragraph num="(i)"> <text>A bachelor's degree from an accredited educational institution; and</text> </paragraph> <paragraph num="(ii)"> <text>At least 5 years of documented experience in human services, 2 years of which include providing administrative or clinical supervision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Duties. The administrator shall ensure that the program complies with all applicable State and federal laws.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Clinical Director.</text> <paragraph num="(1)"> <text>A program may have a clinical director.</text> </paragraph> <paragraph num="(2)"> <text>The clinical director functions under the administrative supervision of the administrator.</text> </paragraph> <paragraph num="(3)"> <text>Qualifications. The clinical director shall have at a minimum:</text> <paragraph num="(a)"> <text>A master's degree in counseling or a related discipline regulated under the Health Occupations Article, Annotated Code of Maryland, and certification or licensure as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or</text> </paragraph> <paragraph num="(b)"> <text>Approval to supervise by the Board of Professional Counselors and Therapists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical Supervisor.</text> <paragraph num="(1)"> <text>A program shall have a clinical supervisor.</text> </paragraph> <paragraph num="(2)"> <text>Qualifications. The clinical supervisor shall:</text> <paragraph num="(a)"> <text>Be employed as a clinical supervisor before October 1, 2002; or</text> </paragraph> <paragraph num="(b)"> <text>Have at a minimum:</text> <paragraph num="(i)"> <text>A master's degree in counseling or a related discipline regulated under the Health Occupations Article, Annotated Code of Maryland, and certification or licensure as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or</text> </paragraph> <paragraph num="(ii)"> <text>Approval to supervise by the Board of Professional Counselors and Therapists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Duties. A clinical supervisor may carry a caseload at the discretion of the administrator.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Staff.</text> <paragraph num="(1)"> <text>Qualifications. All staff employed as alcohol and drug counselors shall, at a minimum be:</text> <paragraph num="(a)"> <text>Licensed or certified as an alcohol and drug counselors by the Board of Professional Counselors and Therapists;</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Board of Professional Counselors and Therapists; or</text> </paragraph> <paragraph num="(c)"> <text>Licensed, certified, or permitted under the Health Occupations Article, Annotated Code of Maryland to provide substance abuse treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Credentials. The administrator shall ensure that program staff, including students, interns, and volunteers, are credentialed and appropriately privileged.</text> </paragraph> <paragraph num="(3)"> <text>Policies and Procedures. All clinical staff, including the administrator, clinical director, and clinical supervisor, shall review the program's policies and procedures and shall sign a statement saying that they reviewed and understood the policies and procedures.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Patient Rights and Grievance Procedures."> <paragraph num="A."> <text>Patient Rights.</text> <paragraph num="(1)"> <text>A program shall:</text> <paragraph num="(a)"> <text>Treat each patient with consideration, respect, and full recognition of the patient's human dignity and individuality;</text> </paragraph> <paragraph num="(b)"> <text>Provide treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;</text> </paragraph> <paragraph num="(c)"> <text>Prevent physical or mental abuse by the program staff;</text> </paragraph> <paragraph num="(d)"> <text>Provide an atmosphere free from discrimination;</text> </paragraph> <paragraph num="(e)"> <text>Not allow use of any physical restraints;</text> </paragraph> <paragraph num="(f)"> <text>Ensure privacy and confidentiality; and</text> </paragraph> <paragraph num="(g)"> <text>Allow the patient the right to refuse participation in any experimental research unless the research complies with 45 CFR Part 46.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program shall post in a conspicuous area and provide to each patient a statement of patients' rights.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Grievance Procedures. A program shall:</text> <paragraph num="(1)"> <text>Have a grievance procedure approved by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Provide the patient upon admission a description of grievance policy and procedure that includes the:</text> <paragraph num="(a)"> <text>Patient's right to grieve program decisions including but not limited to:</text> <paragraph num="(i)"> <text>Discharge; and</text> </paragraph> <paragraph num="(ii)"> <text>Change in status;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Steps of the grievance process; and</text> </paragraph> <paragraph num="(c)"> <text>Levels to which the grievance may be taken;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Take no retaliation against a patient who presents a grievance; and</text> </paragraph> <paragraph num="(4)"> <text>Inform each patient if revisions are made to the grievance policy and the nature and extent of the revisions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nondiscrimination. A program may not discriminate in the provision of services on the basis of race, creed, color, age, gender, sexual orientation, national origin, marital status, disabilities, and any other classification prohibited under State or federal law including:</text> <paragraph num="(1)"> <text>Americans with Disabilities Act, 28 CFR 35; and</text> </paragraph> <paragraph num="(2)"> <text>Fair Housing Act, 42 U.S.C. §3604.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Records."> <paragraph num="A."> <text>Program Records.</text> <paragraph num="(1)"> <text>A program shall either manually or electronically maintain a record for each patient that includes, but is not limited to:</text> <paragraph num="(a)"> <text>A patient identifier, which may be a name, number, or an identifying code;</text> </paragraph> <paragraph num="(b)"> <text>Intake information, including the patient's name, date of admission, summary of medical examinations, allergies to medication, and laboratory reports;</text> </paragraph> <paragraph num="(c)"> <text>Assessments, individualized treatment plans, progress notes, and consent to disclose information if needed;</text> </paragraph> <paragraph num="(d)"> <text>Documentation of each program contact with the patient;</text> </paragraph> <paragraph num="(e)"> <text>Critical incident reports documented on the day of the incident; and</text> </paragraph> <paragraph num="(f)"> <text>A discharge summary.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program shall maintain Medicaid patient records for at least 6 years following discharge, and all other patient records for at least 3 years as required by Health-General Article, §4-403, Annotated Code of Maryland, and shall:</text> <paragraph num="(a)"> <text>Maintain, transfer, and destroy all records in a manner consistent with the medical records confidentiality and disclosure requirements of:</text> <paragraph num="(i)"> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health-General Article, §4-403, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>42 CFR Part 2;</text> </paragraph> <paragraph num="(iv)"> <text>The Health Insurance Portability and Accountability Act (HIPAA); and</text> </paragraph> <paragraph num="(v)"> <text>45 CFR Parts 160 and 164;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Locate all records so that they are convenient and available to designated staff; and</text> </paragraph> <paragraph num="(c)"> <text>Provide a designated staff member responsible for appropriate records control, including storage, security, and indexing records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Management Information System. The program shall:</text> <paragraph num="(1)"> <text>Participate in the Administration's management information system;</text> </paragraph> <paragraph num="(2)"> <text>Comply with reporting requirements as required by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Complete and submit the driving while intoxicated data collection form chosen by the Administration for those arrested for driving while intoxicated or driving under the influence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Electronic Records.</text> <paragraph num="(1)"> <text>Electronic records shall be maintained according to requirements set forth in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A companion hard copy file shall be maintained at the program and shall contain the following:</text> <paragraph num="(a)"> <text>Informed consent to treatment signed by the patient;</text> </paragraph> <paragraph num="(b)"> <text>Any requests for or releases of information shared with other entities signed by the patient;</text> </paragraph> <paragraph num="(c)"> <text>Any treatment plan or treatment plan update signed by the patient; and</text> </paragraph> <paragraph num="(d)"> <text>Any program agreements or patient/counselor behavioral contracts signed by the patient.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08-1" heading="Outcome Evaluation."> <paragraph num="A."> <text>The Administration shall annually evaluate all publicly funded substance abuse treatment programs certified under this subtitle, using federal outcomes measures or other subsequently adopted federal standards, to determine the extent that individuals who have received treatment under these programs have:</text> <paragraph num="(1)"> <text>Been successfully retained in the treatment program;</text> </paragraph> <paragraph num="(2)"> <text>Been successfully discharged from the treatment program;</text> </paragraph> <paragraph num="(3)"> <text>Reduced their substance use;</text> </paragraph> <paragraph num="(4)"> <text>Successfully attained, maintained, or increased their employment;</text> </paragraph> <paragraph num="(5)"> <text>Demonstrated a decrease in engaging in criminal activity; and</text> </paragraph> <paragraph num="(6)"> <text>Successfully established or maintained stable living arrangements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All publicly funded programs shall fully comply with the Administration’s reporting requirements completing all data fields required within the Administration’s management information system as directed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Referral Agreements and Program Cooperation."> <paragraph num="A."> <text>A program shall coordinate patient care with other community service providers to ensure that the widest range of appropriate services are available to patients.</text> </paragraph> <paragraph num="B."> <text>Referral Agreements.</text> <paragraph num="(1)"> <text>A program shall establish referral agreements with other human service agencies as required by COMAR 10.47.02.</text> </paragraph> <paragraph num="(2)"> <text>The program shall make the referral agreements available to the Administration for review.</text> </paragraph> <paragraph num="(3)"> <text>A program shall have referral agreements with other programs for individuals with disabilities whom the program may be unable to accommodate.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 8, 1985 (12:7 Md. R. 703)</annotation> <annotation type="History" subtype="Administrative History">Regulations .26H, .30L, and .31K amended effective June 17, 1985 (12:12 Md. R. 1165)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.33, Certification of Alcoholism and Alcohol Abuse Facilities, repealed and new Regulations .01—.09, Requirements, adopted effective June 10, 2002 (29:11 Md. R. 882)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08-1 adopted effective December 12, 2013 (40:24 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="02" heading="Specific Program Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth additional requirements that a program shall meet to be certified to offer a particular level of treatment. The program shall meet the requirements of COMAR 10.47.01 and 10.47.03.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.47.01.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Early Intervention Level 0.5."> <paragraph num="A."> <text>Prevention Program Description. The prevention program shall treat patients who are, for a known reason, at risk for developing alcohol or other drug abuse or dependence but for whom there is not yet sufficient information to document alcohol or other drug abuse or dependence.</text> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment shall meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level 0.5, or its equivalent as approved by the Administration.</text> </paragraph> <paragraph num="C."> <text>Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="D."> <text>Program services include:</text> <paragraph num="(1)"> <text>Assessments as described in COMAR 10.47.01.04 within 2 weeks of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04, completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days;</text> </paragraph> <paragraph num="(3)"> <text>Group or individual counseling, or both, as clinically indicated;</text> </paragraph> <paragraph num="(4)"> <text>Family counseling, as clinically indicated;</text> </paragraph> <paragraph num="(5)"> <text>Alcohol and drug education; and</text> </paragraph> <paragraph num="(6)"> <text>Referral for further assessment or to another level of treatment, as clinically indicated.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. The prevention program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Mental health services;</text> </paragraph> <paragraph num="(2)"> <text>Social services; and</text> </paragraph> <paragraph num="(3)"> <text>Substance abuse treatment programs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Outpatient Services Level I."> <paragraph num="A."> <text>Program Description. The program shall provide outpatient evaluation and treatment to patients who require services for less than 9 hours weekly for adults and 6 hours weekly for adolescents.</text> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level I, or its equivalent as approved by the Administration; and</text> </paragraph> <paragraph num="(2)"> <text>Have a physical and emotional status that allows them to function in their usual environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>The adult patient to alcohol and drug counselor ratio may not exceed 30 adult patients weekly to one full-time alcohol and drug counselor.</text> </paragraph> <paragraph num="(3)"> <text>The child and adolescent patient to alcohol and drug counselor ratio may not exceed 25 adolescent patients weekly to one full-time alcohol and drug counselor.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days;</text> </paragraph> <paragraph num="(3)"> <text>Case management services;</text> </paragraph> <paragraph num="(4)"> <text>Group or individual counseling sessions;</text> </paragraph> <paragraph num="(5)"> <text>Family services that shall include an assessment for family treatment needs and, as clinically appropriate:</text> <paragraph num="(a)"> <text>Alcohol and drug education; and</text> </paragraph> <paragraph num="(b)"> <text>Family counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Medical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Intensive Outpatient Services Level II.1 and Partial Hospitalization Services Level II.5."> <paragraph num="A."> <text>Program Description. A program shall provide structured outpatient evaluation and treatment to patients who require programming:</text> <paragraph num="(1)"> <text>From 9 to 20 hours weekly for adult intensive outpatient services;</text> </paragraph> <paragraph num="(2)"> <text>From 6 to 20 hours weekly for adolescent intensive outpatient services, based on the adolescents' developmental and clinical needs; and</text> </paragraph> <paragraph num="(3)"> <text>From 20 to 35 hours weekly for adult and adolescent partial hospitalization services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment shall meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for either Level II.1 or Level II.5, or its equivalent as approved by the Administration.</text> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 1 week of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 5 working days of the comprehensive assessment and updated every 30 days;</text> </paragraph> <paragraph num="(3)"> <text>Case management services;</text> </paragraph> <paragraph num="(4)"> <text>At least one group counseling session a week;</text> </paragraph> <paragraph num="(5)"> <text>At least one individual session every 2 weeks;</text> </paragraph> <paragraph num="(6)"> <text>Family services, which may include an assessment for family needs and, as clinically appropriate:</text> <paragraph num="(a)"> <text>Alcohol and drug education; and</text> </paragraph> <paragraph num="(b)"> <text>Family counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff person shall:</text> <paragraph num="(1)"> <text>Write a patient progress note at the end of each week that services are provided; and</text> </paragraph> <paragraph num="(2)"> <text>Place the progress note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Medical services with medical consultations available:</text> <paragraph num="(a)"> <text>Within 24 hours of a request for service by telephone for intensive outpatient services;</text> </paragraph> <paragraph num="(b)"> <text>Within 72 hours of a request for service in person for intensive outpatient services;</text> </paragraph> <paragraph num="(c)"> <text>Within 8 hours of a request for service by telephone for partial hospitalization services; and</text> </paragraph> <paragraph num="(d)"> <text>Within 48 hours of a request for service in person for partial hospitalization services;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services with psychiatric consultations available:</text> <paragraph num="(a)"> <text>Within 24 hours of a request for service by telephone for intensive outpatient services;</text> </paragraph> <paragraph num="(b)"> <text>Within 72 hours of a request for service in person for intensive outpatient services;</text> </paragraph> <paragraph num="(c)"> <text>Within 8 hours of a request for service by telephone for partial hospitalization services; and</text> </paragraph> <paragraph num="(d)"> <text>Within 48 hours of a request for service in person for partial hospitalization services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Residential Service — Clinically Managed Low Intensity Treatment Level III.1."> <paragraph num="A."> <text>Program Description. Clinically managed low intensity treatment programs shall offer treatment services at least 5 hours a week directed toward preventing relapse, applying recovery skills, promoting personal responsibility, and reintegration.</text> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.1, or its equivalent as approved by the Administration; and</text> </paragraph> <paragraph num="(2)"> <text>Be capable of self-care but not ready to return to family or independent living.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>A clinically managed low intensity treatment program shall employ:</text> <paragraph num="(a)"> <text>One individual as clinical supervisor who may also be the program's administrator;</text> </paragraph> <paragraph num="(b)"> <text>Another individual as house manager;</text> </paragraph> <paragraph num="(c)"> <text>At least one staff member to be on duty at all times; and</text> </paragraph> <paragraph num="(d)"> <text>At least one staff member who is certified in cardiopulmonary resuscitation, and who has been trained in crisis intervention to be on duty between 11 p.m. and 7 a.m.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor.</text> </paragraph> <paragraph num="(4)"> <text>Staff may not dispense medications.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A clinically managed low intensity treatment program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 60 days;</text> </paragraph> <paragraph num="(3)"> <text>Periodic group counseling that focuses on relapse prevention;</text> </paragraph> <paragraph num="(4)"> <text>Case management services;</text> </paragraph> <paragraph num="(5)"> <text>Individual counseling, at least monthly; and</text> </paragraph> <paragraph num="(6)"> <text>Leisure and recreational activities.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Physical examinations as determined by medical condition, within a reasonable time;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services, which shall include:</text> <paragraph num="(a)"> <text>Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and</text> </paragraph> <paragraph num="(b)"> <text>Services appropriate to the severity and urgency of the patient's mental condition;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Legal assistance;</text> </paragraph> <paragraph num="(6)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(7)"> <text>Social services;</text> </paragraph> <paragraph num="(8)"> <text>Family services; and</text> </paragraph> <paragraph num="(9)"> <text>Education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Residential Services — Clinically Managed Medium Intensity Treatment Level III.3."> <paragraph num="A."> <text>Program Description. A clinically managed medium intensity treatment program provides a structured environment in combination with medium intensity treatment and ancillary services to support and promote recovery.</text> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.3, or its equivalent as approved by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Are chronic alcohol or other drug dependent individuals;</text> </paragraph> <paragraph num="(3)"> <text>Do not need skilled nursing care;</text> </paragraph> <paragraph num="(4)"> <text>May have a history of multiple admissions to alcohol or drug abuse or dependence programs as defined in COMAR 10.47.01;</text> </paragraph> <paragraph num="(5)"> <text>May have physical and mental disabilities as a result of prolonged alcohol or other drug use; and</text> </paragraph> <paragraph num="(6)"> <text>Have been identified as individuals for whom a controlled environment and supportive therapy are necessary for an indefinite period of time.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor.</text> </paragraph> <paragraph num="(3)"> <text>At least one staff member certified in cardiopulmonary resuscitation and trained in crisis intervention shall be on duty between 11 p.m. and 7 a.m.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 1 week of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 3 working days of the comprehensive assessment and updated every 30 days;</text> </paragraph> <paragraph num="(3)"> <text>Alcohol and drug education;</text> </paragraph> <paragraph num="(4)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(5)"> <text>Leisure and recreation counseling; and</text> </paragraph> <paragraph num="(6)"> <text>Assistance with vocational issues.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff shall write a patient progress note at the end of each week services are provided and place the progress note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Physical examinations as determined by medical condition, within a reasonable time;</text> </paragraph> <paragraph num="(2)"> <text>Medical care;</text> </paragraph> <paragraph num="(3)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(4)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(5)"> <text>Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition:</text> <paragraph num="(a)"> <text>Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and</text> </paragraph> <paragraph num="(b)"> <text>At least one of the following services:</text> <paragraph num="(i)"> <text>Services available by telephone within 8 hours of a request; or</text> </paragraph> <paragraph num="(ii)"> <text>Services available onsite or closely coordinated off-site within 24 hours of a request;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(7)"> <text>Legal assistance;</text> </paragraph> <paragraph num="(8)"> <text>Family services; and</text> </paragraph> <paragraph num="(9)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Residential Services — Clinically Managed High Intensity Treatment Level III.5."> <paragraph num="A."> <text>Program Description. A clinically managed high intensity residential program shall:</text> <paragraph num="(1)"> <text>Provide a highly structured environment in combination with moderate to high intensity treatment and ancillary services to support and promote recovery; and</text> </paragraph> <paragraph num="(2)"> <text>Be characterized by its reliance on the treatment community as a therapeutic agent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.5, or its equivalent as approved by the Administration.</text> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>A program shall have sufficient physician, physician assistant, or nurse practitioner services to:</text> <paragraph num="(a)"> <text>Provide initial diagnostic work-up;</text> </paragraph> <paragraph num="(b)"> <text>Provide identification of medical and surgical problems for referral; and</text> </paragraph> <paragraph num="(c)"> <text>Handle medical emergencies when necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The patient to alcohol and drug counselor ratio may not exceed 15 patients for one full-time alcohol and drug counselor.</text> </paragraph> <paragraph num="(4)"> <text>At least one staff member certified in cardiopulmonary resuscitation and trained in crisis intervention shall be on duty between 11 p.m. and 7 a.m.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>A preliminary medical assessment within 36 hours of the patient's admission;</text> </paragraph> <paragraph num="(2)"> <text>A physical examination by a medical doctor, physician assistant, or nurse practitioner within the first week of the patient's admission;</text> </paragraph> <paragraph num="(3)"> <text>An assessment as described in COMAR 10.47.01.04 within 2 days of admission;</text> </paragraph> <paragraph num="(4)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 2 working days of the comprehensive assessment with a treatment plan update every 30 days;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring of medication, as necessary; and</text> </paragraph> <paragraph num="(6)"> <text>A minimum of 36 hours of therapeutic activities a week, including but not limited to:</text> <paragraph num="(a)"> <text>At least weekly individual counseling;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Alcohol and drug education;</text> </paragraph> <paragraph num="(d)"> <text>Career counseling;</text> </paragraph> <paragraph num="(e)"> <text>Nutrition education; and</text> </paragraph> <paragraph num="(f)"> <text>Family services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff shall write a patient progress note at the end of each week services are provided and place the progress note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Medical care;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition:</text> <paragraph num="(a)"> <text>Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and</text> </paragraph> <paragraph num="(b)"> <text>At least one of the following services:</text> <paragraph num="(i)"> <text>Services available by telephone within 8 hours of a request; or</text> </paragraph> <paragraph num="(ii)"> <text>Services available on-site or closely coordinated off-site within 24 hours of a request;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Residential Services — Medically Monitored Intensive Inpatient Treatment Level III.7."> <paragraph num="A."> <text>Program Description. A medically monitored intensive inpatient treatment program shall:</text> <paragraph num="(1)"> <text>Offer a planned regimen of 24-hour professionally directed evaluation, care, and treatment in an inpatient setting;</text> </paragraph> <paragraph num="(2)"> <text>Act as an Intermediate Care Facility Type C/D; and</text> </paragraph> <paragraph num="(3)"> <text>Meet the certification requirements for detoxification services as described in COMAR 10.47.02.10E.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Patients who are appropriate for this level of treatment:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.7, or its equivalent as approved by the Administration; and</text> </paragraph> <paragraph num="(2)"> <text>Require 24-hour monitoring and care for subacute biomedical and emotional or behavioral conditions severe enough to warrant inpatient treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing. A program shall have:</text> <paragraph num="(1)"> <text>Appropriately credentialed staff as described in COMAR 10.47.01.06;</text> </paragraph> <paragraph num="(2)"> <text>Staffing which allows for detoxification and can provide services necessary for treatment of coexisting medical, emotional, or behavioral problems that could interfere with recovery;</text> </paragraph> <paragraph num="(3)"> <text>A patient to alcohol and drug counselor ratio not exceeding eight patients for one full-time alcohol and drug counselor;</text> </paragraph> <paragraph num="(4)"> <text>On-site physician, physician assistant, or nurse practitioner coverage available to provide initial assessment and documented referral for care, and to monitor progress in treatment;</text> </paragraph> <paragraph num="(5)"> <text>A physician on call 24 hours a day;</text> </paragraph> <paragraph num="(6)"> <text>Nursing services, between 7 a.m. and 11 p.m., 7 days a week, including:</text> <paragraph num="(a)"> <text>8 hours a day, 5 days a week coverage by a registered nurse; and</text> </paragraph> <paragraph num="(b)"> <text>The remainder of coverage by a licensed practical nurse; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>At least two employees on duty between the hours of 11 p.m. and 7 a.m., 7 days a week, trained in crisis management and cardiopulmonary resuscitation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 2 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04C completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment with a treatment plan update completed every 7 days;</text> </paragraph> <paragraph num="(3)"> <text>A minimum of 36 hours of therapeutic activities a week including, but not limited to:</text> <paragraph num="(a)"> <text>A minimum of one weekly individual counseling session;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Alcohol and drug education;</text> </paragraph> <paragraph num="(d)"> <text>Nutrition education;</text> </paragraph> <paragraph num="(e)"> <text>Weekly family sessions; and</text> </paragraph> <paragraph num="(f)"> <text>Case management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Medically Monitored Services.</text> <paragraph num="(1)"> <text>Nursing Services. Services shall include:</text> <paragraph num="(a)"> <text>An assessment at the time of the patient's admission, including a mental health focused assessment:</text> <paragraph num="(i)"> <text>Approved by the registered nurse and program physician;</text> </paragraph> <paragraph num="(ii)"> <text>Completed by qualified staff; and</text> </paragraph> <paragraph num="(iii)"> <text>Overseen by a registered nurse for patients admitted with any prescribed medication; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Medication monitoring conducted by:</text> <paragraph num="(i)"> <text>The registered nurse or overseen by the registered nurse in conjunction with the program's physician; and</text> </paragraph> <paragraph num="(ii)"> <text>Qualified nursing staff for patients who are admitted on or are prescribed any medications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Physician, Physician Assistant, or Nurse Practitioner Services.</text> <paragraph num="(a)"> <text>A physician, physician assistant, or nurse practitioner shall:</text> <paragraph num="(i)"> <text>Assess a patient within 24 hours of admission; and</text> </paragraph> <paragraph num="(ii)"> <text>Continue to assess the patient as is medically necessary after the first 24 hours of admission.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A physician, physician assistant, or nurse practitioner shall conduct a physical examination of a patient within 96 hours of admission to the program.</text> </paragraph> <paragraph num="(c)"> <text>A physician or physician assistant shall assess a patient undergoing detoxification within 24 hours of admission or earlier if it is medically necessary to conduct the assessment in less than 24 hours.</text> </paragraph> <paragraph num="(d)"> <text>A physician or physician assistant shall provide on-site monitoring and further evaluation of patients undergoing detoxification on a daily basis, if medically necessary.</text> </paragraph> <paragraph num="(e)"> <text>A physician or physician assistant shall be available by telephone at all times to consult about patients undergoing detoxification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Documentation. A designated clinical staff shall write a patient progress note at the end of each day services are provided and place the progress note in the patient's record.</text> </paragraph> <paragraph num="G."> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(1)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(2)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(3)"> <text>Mental health services;</text> </paragraph> <paragraph num="(4)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(5)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(6)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Detoxification Services."> <paragraph num="A."> <text>Description of Services. A detoxification program shall provide services to an intoxicated patient by:</text> <paragraph num="(1)"> <text>Monitoring the decreasing amount of psychoactive substances in the body;</text> </paragraph> <paragraph num="(2)"> <text>Managing the withdrawal symptoms; and</text> </paragraph> <paragraph num="(3)"> <text>Motivating the individual to participate in an appropriate treatment program for alcohol or other drug dependence.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A detoxification program shall:</text> <paragraph num="(1)"> <text>Avoid potentially harmful consequences of withdrawal from alcohol and drug dependence as medically possible;</text> </paragraph> <paragraph num="(2)"> <text>Provide a space to house and observe patients suffering from withdrawal symptoms;</text> </paragraph> <paragraph num="(3)"> <text>Ease physical discomfort during the withdrawal process; and</text> </paragraph> <paragraph num="(4)"> <text>Facilitate transition to a treatment continuum of care which may include:</text> <paragraph num="(a)"> <text>Ongoing alcohol or drug treatment in a residential or outpatient treatment program;</text> </paragraph> <paragraph num="(b)"> <text>Referral to mental health treatment; and</text> </paragraph> <paragraph num="(c)"> <text>Referral to self-help recovery programming.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Level I-D Ambulatory Detoxification Without Extended On-Site Monitoring.</text> <paragraph num="(1)"> <text>Description of Services.</text> <paragraph num="(a)"> <text>Ambulatory detoxification without extended on-site monitoring services offers evaluation, detoxification, and referral under medical supervision to patients who require services in an office setting or healthcare, correctional, or addictions treatment facility.</text> </paragraph> <paragraph num="(b)"> <text>This program may be certified as a separate program or be combined with a Level I outpatient program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Alcohol and Drug Abuse Administration.</text> </paragraph> <paragraph num="(3)"> <text>Staffing.</text> <paragraph num="(a)"> <text>A program shall employ:</text> <paragraph num="(i)"> <text>Appropriately credentialed staff as described in COMAR 10.47.01.06;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed physician; and</text> </paragraph> <paragraph num="(iii)"> <text>A registered nurse.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>To perform the program's services, a program shall also employ sufficient licensed health care professionals, which may include:</text> <paragraph num="(i)"> <text>Physician assistants;</text> </paragraph> <paragraph num="(ii)"> <text>Nurse practitioners;</text> </paragraph> <paragraph num="(iii)"> <text>Registered nurses; or</text> </paragraph> <paragraph num="(iv)"> <text>Licensed practical nurses.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Services. Detoxification services shall include:</text> <paragraph num="(a)"> <text>A physical examination by a medical doctor, physician assistant, or nurse practitioner within a reasonable time frame;</text> </paragraph> <paragraph num="(b)"> <text>An assessment as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(c)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(d)"> <text>Administration and monitoring of medication, including administration and monitoring of psychotropic medication by qualified nursing staff, as necessary;</text> </paragraph> <paragraph num="(e)"> <text>Monitoring of vital signs;</text> </paragraph> <paragraph num="(f)"> <text>Discharge or transfer planning as described in COMAR 10.47.01.04; and</text> </paragraph> <paragraph num="(g)"> <text>A mental health focused assessment for patients taking or prescribed psychotropic medication:</text> <paragraph num="(i)"> <text>Approved by the registered nurse and the program physician; and</text> </paragraph> <paragraph num="(ii)"> <text>Overseen by the registered nurse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation. The clinical staff providing services shall:</text> <paragraph num="(a)"> <text>Write a patient progress note after each counseling session; and</text> </paragraph> <paragraph num="(b)"> <text>Place the note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(a)"> <text>Medical, psychological, and psychiatric consultation;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(c)"> <text>Transportation services; and</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse/dependence and mental health treatment programs.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Emergency Services.</text> <paragraph num="(a)"> <text>A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services.</text> </paragraph> <paragraph num="(b)"> <text>The agreement shall include:</text> <paragraph num="(i)"> <text>An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care;</text> </paragraph> <paragraph num="(ii)"> <text>Cooperative arrangements that specifically assign responsibility to provide transportation;</text> </paragraph> <paragraph num="(iii)"> <text>The manner in which hospital on-call coverage is provided;</text> </paragraph> <paragraph num="(iv)"> <text>A mechanism to provide psychiatric evaluation, if necessary;</text> </paragraph> <paragraph num="(v)"> <text>A prescreening protocol for patients referred to the ambulatory detoxification program from the hospital; and</text> </paragraph> <paragraph num="(vi)"> <text>A written protocol for the transfer of a patient to continued treatment.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Level II-D Ambulatory Detoxification with Extended On-Site Monitoring.</text> <paragraph num="(1)"> <text>Description of Services. An ambulatory detoxification with extended on-site monitoring services shall:</text> <paragraph num="(a)"> <text>Offer evaluation, detoxification, and referral under medical supervision to patients who require services in an office setting, healthcare, correctional, or addictions treatment facility; and</text> </paragraph> <paragraph num="(b)"> <text>Be certified as a separate program or be combined with intensive outpatient or partial hospitalization treatment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for either Level II.1 or Level II.5, or its equivalent as approved by the Administration.</text> </paragraph> <paragraph num="(3)"> <text>Staffing. A program shall employ:</text> <paragraph num="(a)"> <text>Appropriately credentialed staff as described in COMAR 10.47.01.06;</text> </paragraph> <paragraph num="(b)"> <text>A licensed physician, physician assistant, or a licensed nurse practitioner; and</text> </paragraph> <paragraph num="(c)"> <text>Additional medical staff which shall be a:</text> <paragraph num="(i)"> <text>Licensed physician's assistant;</text> </paragraph> <paragraph num="(ii)"> <text>Registered nurse; or</text> </paragraph> <paragraph num="(iii)"> <text>Licensed practical nurse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Services. Detoxification services shall include:</text> <paragraph num="(a)"> <text>A physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission;</text> </paragraph> <paragraph num="(b)"> <text>An assessment as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(c)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(d)"> <text>Administering and monitoring of medication, as necessary;</text> </paragraph> <paragraph num="(e)"> <text>Monitoring of vital signs; and</text> </paragraph> <paragraph num="(f)"> <text>Discharge or transfer planning as described in COMAR 10.47.01.04.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation. The clinical staff person providing the service shall:</text> <paragraph num="(a)"> <text>Write a patient progress note after each counseling session; and</text> </paragraph> <paragraph num="(b)"> <text>Place the note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Referral Services. The program shall offer or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(a)"> <text>Medical, psychological, and psychiatric consultation;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(c)"> <text>Transportation services; and</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse/dependence and mental health treatment programs.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Emergency Services. A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. This agreement shall include:</text> <paragraph num="(a)"> <text>An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care;</text> </paragraph> <paragraph num="(b)"> <text>Cooperative arrangements that specifically assign responsibility to provide transportation;</text> </paragraph> <paragraph num="(c)"> <text>The manner in which hospital on-call coverage is provided;</text> </paragraph> <paragraph num="(d)"> <text>A mechanism to provide psychiatric evaluation, if necessary;</text> </paragraph> <paragraph num="(e)"> <text>A prescreening protocol for patients referred to the ambulatory detoxification program from the hospital; and</text> </paragraph> <paragraph num="(f)"> <text>A written protocol for the transfer of a patient to continued treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Level III.2-D Clinically Managed Residential Detoxification.</text> <paragraph num="(1)"> <text>Description of Services. Clinically managed residential detoxification services are provided for patients whose intoxication or withdrawal signs and symptoms are sufficiently severe to require 24-hour structure and support and may be offered at Level III.3 or Level III.5 programs.</text> </paragraph> <paragraph num="(2)"> <text>Patients who are appropriate for this level of treatment:</text> <paragraph num="(a)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Are intoxicated, show moderate withdrawal signs and symptoms, or evidence that withdrawal is imminent.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staffing. A program:</text> <paragraph num="(a)"> <text>Shall employ appropriately credentialed staff as described in COMAR 10.47.01.06;</text> </paragraph> <paragraph num="(b)"> <text>May not have a patient to alcohol and drug counselor ratio that exceeds eight patients to one full-time alcohol and drug counselor if counseling services are available;</text> </paragraph> <paragraph num="(c)"> <text>Shall have a physician, physician assistant, or nurse practitioner available 24 hours a day;</text> </paragraph> <paragraph num="(d)"> <text>Shall provide licensed nursing services between 7 a.m. and 11 p.m. daily as follows:</text> <paragraph num="(i)"> <text>A registered nurse shall provide at least 8 hours of coverage a day 5 days a week; and</text> </paragraph> <paragraph num="(ii)"> <text>The remainder of coverage may be provided by either a licensed practical nurse or a registered nurse; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Shall have at least two employees trained in crisis management and cardiopulmonary resuscitation on duty between the hours of 11 p.m. and 7 a.m., 7 days a week.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(a)"> <text>Nursing assessment upon admission;</text> </paragraph> <paragraph num="(b)"> <text>Physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission if clinically indicated;</text> </paragraph> <paragraph num="(c)"> <text>Assessment as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(d)"> <text>Individualized treatment plan appropriate to a short term detoxification treatment regimen;</text> </paragraph> <paragraph num="(e)"> <text>Discharge or transfer planning as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(f)"> <text>Monitoring of vital signs as clinically indicated;</text> </paragraph> <paragraph num="(g)"> <text>Administering of medication, as necessary; and</text> </paragraph> <paragraph num="(h)"> <text>Adjunct services, which may include:</text> <paragraph num="(i)"> <text>Basic alcohol or other drug education;</text> </paragraph> <paragraph num="(ii)"> <text>Family services; and</text> </paragraph> <paragraph num="(iii)"> <text>Motivational counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation. Designated clinical staff shall:</text> <paragraph num="(a)"> <text>Write a patient progress note at the end of each day services are provided; and</text> </paragraph> <paragraph num="(b)"> <text>Place the progress note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:</text> <paragraph num="(a)"> <text>Medical, psychological, and psychiatric consultation;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(c)"> <text>Transportation services; and</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse or dependence and mental health treatment programs.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Emergency Services.</text> <paragraph num="(a)"> <text>A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services.</text> </paragraph> <paragraph num="(b)"> <text>The agreement shall include:</text> <paragraph num="(i)"> <text>An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care;</text> </paragraph> <paragraph num="(ii)"> <text>Cooperative arrangements that specifically assign responsibility to provide transportation;</text> </paragraph> <paragraph num="(iii)"> <text>The manner in which hospital on-call coverage is provided;</text> </paragraph> <paragraph num="(iv)"> <text>A mechanism to provide psychiatric evaluation, if necessary;</text> </paragraph> <paragraph num="(v)"> <text>A prescreening protocol for patients referred to the inpatient detoxification program from the hospital; and</text> </paragraph> <paragraph num="(vi)"> <text>A written protocol for the transfer of a patient to continued treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Patients Treated with Opioid Maintenance Medication.</text> <paragraph num="(a)"> <text>A detoxification facility is not limited in the number of admissions for detoxification of patients who are treated with opioid maintenance medication.</text> </paragraph> <paragraph num="(b)"> <text>A detoxification facility is not limited in the total number of doses of opioid maintenance medication that it will accept from patients who:</text> <paragraph num="(i)"> <text>Attend the detoxification program; and</text> </paragraph> <paragraph num="(ii)"> <text>Require opioid maintenance medication for opioid detoxification or detoxification for substances other than opioids.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Level III.7-D Medically Monitored Inpatient Detoxification.</text> <paragraph num="(1)"> <text>Description of Services.</text> <paragraph num="(a)"> <text>Medically monitored inpatient detoxification services offer 24-hour medically supervised evaluation and withdrawal management by medical professionals at an inpatient facility and may be offered with therapeutic community or medically monitored intensive inpatient treatment.</text> </paragraph> <paragraph num="(b)"> <text>This is an Intermediate Care Facility/C.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patients who are appropriate for this level of treatment:</text> <paragraph num="(a)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Administration, for this level of treatment; and</text> </paragraph> <paragraph num="(b)"> <text>Are intoxicated, show physical signs of withdrawal, or both.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staffing. A program:</text> <paragraph num="(a)"> <text>Shall employ appropriately credentialed staff as described in COMAR 10.47.01.06;</text> </paragraph> <paragraph num="(b)"> <text>May not have a patient to alcohol and drug counselor ratio that exceeds eight patients to one full-time alcohol and drug counselor if counseling services are available;</text> </paragraph> <paragraph num="(c)"> <text>Shall have on-site physician, physician assistant, or nurse practitioner coverage available to provide initial assessment and documented referral for care, and to monitor progress in treatment;</text> </paragraph> <paragraph num="(d)"> <text>Shall have a physician, physician assistant, or nurse practitioner on call 24 hours a day; and</text> </paragraph> <paragraph num="(e)"> <text>Shall have nursing services during all hours of service, including at least 8 hours of service provided by a licensed registered nurse.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(a)"> <text>Nursing assessment upon admission;</text> </paragraph> <paragraph num="(b)"> <text>Physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission;</text> </paragraph> <paragraph num="(c)"> <text>An assessment as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(d)"> <text>Individualized treatment plan appropriate to a short term detoxification treatment regimen;</text> </paragraph> <paragraph num="(e)"> <text>Discharge or transfer planning as described in COMAR 10.47.01.04;</text> </paragraph> <paragraph num="(f)"> <text>Monitoring of vital signs;</text> </paragraph> <paragraph num="(g)"> <text>Administering of medication, as necessary; and</text> </paragraph> <paragraph num="(h)"> <text>Adjunct services, which may include:</text> <paragraph num="(i)"> <text>Basic alcohol and drug education;</text> </paragraph> <paragraph num="(ii)"> <text>Family services; and</text> </paragraph> <paragraph num="(iii)"> <text>Motivational counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation. Designated clinical staff shall write a patient progress note at the end of each day services are provided and place the progress note in the patient's record.</text> </paragraph> <paragraph num="(6)"> <text>Referral Services. The program shall offer or have available through referral the following:</text> <paragraph num="(a)"> <text>Medical, psychological, and psychiatric consultation;</text> </paragraph> <paragraph num="(b)"> <text>Laboratory services;</text> </paragraph> <paragraph num="(c)"> <text>Transportation services; and</text> </paragraph> <paragraph num="(d)"> <text>Substance abuse or dependence and mental health treatment programs.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. This agreement shall include:</text> <paragraph num="(a)"> <text>An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care;</text> </paragraph> <paragraph num="(b)"> <text>Cooperative arrangements that specifically assign responsibility to provide transportation;</text> </paragraph> <paragraph num="(c)"> <text>The manner in which hospital on-call coverage is provided;</text> </paragraph> <paragraph num="(d)"> <text>A mechanism to provide psychiatric evaluation, if necessary;</text> </paragraph> <paragraph num="(e)"> <text>A prescreening protocol for patients referred to the inpatient detoxification program from the hospital; and</text> </paragraph> <paragraph num="(f)"> <text>A written protocol for the transfer of a patient to continued treatment.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Patients Treated with Opioid Maintenance Medication.</text> <paragraph num="(a)"> <text>A detoxification facility is not limited in the number of admissions for detoxification of patients who are treated with opioid maintenance medication.</text> </paragraph> <paragraph num="(b)"> <text>A detoxification facility is not limited in the total number of doses of opioid maintenance medication that it will accept from patients who:</text> <paragraph num="(i)"> <text>Attend the detoxification program; and</text> </paragraph> <paragraph num="(ii)"> <text>Require opioid maintenance medication for opioid detoxification or detoxification for substances other than opioids</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Opioid Maintenance Therapy."> <paragraph num="A."> <text>Program Description. Opioid maintenance therapy:</text> <paragraph num="(1)"> <text>Uses pharmacological interventions, including full and partial opiate agonist treatment medications, to provide treatment, support, and recovery to opioid-addicted patients;</text> </paragraph> <paragraph num="(2)"> <text>Is a separate service that is certified and offered by a program as described in COMAR 10.47.02.03 — .11;</text> </paragraph> <paragraph num="(3)"> <text>Complies with the requirements under this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Can be provided in correctional facility based programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program shall comply with federal regulation 42 CFR 8.</text> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>The patient to alcohol and drug counselor ratio may not exceed 50 patients to one full-time counselor.</text> </paragraph> <paragraph num="(2)"> <text>Medical Director. The program shall have a medical director who is a physician and who:</text> <paragraph num="(a)"> <text>Has 3 years documented experience providing services to persons who are addicted to alcohol or other drugs, including at least 1 year of experience in the treatment of opioid addiction with opioid maintenance therapy;</text> </paragraph> <paragraph num="(b)"> <text>Meets at least one of the following criteria:</text> <paragraph num="(i)"> <text>Has been continuously employed as the medical director for opioid maintenance therapy programs from or before August 1, 2002;</text> </paragraph> <paragraph num="(ii)"> <text>Is certified in addiction medicine by the American Society of Addiction Medicine;</text> </paragraph> <paragraph num="(iii)"> <text>Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.; or</text> </paragraph> <paragraph num="(iv)"> <text>Is certified in added qualifications in addiction medicine by the appropriate specialty boards of the American Osteopathic Association; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Takes an active part in interdisciplinary team meetings, not less than every 2 weeks.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A program unable to hire a medical director who meets the criteria set forth in §C(2) of this chapter may hire an interim medical director under the following conditions:</text> <paragraph num="(a)"> <text>The program shall submit a training plan for the interim medical director to the Administration for approval;</text> </paragraph> <paragraph num="(b)"> <text>The plan shall address a means for achieving minimal competencies and proficiencies until the interim medical director meets qualifications set forth in §C(1) of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>The interim medical director shall meet the qualifications within 48 months of being hired.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An opioid maintenance therapy program shall:</text> <paragraph num="(1)"> <text>Have hours that meet the needs of the patients;</text> </paragraph> <paragraph num="(2)"> <text>Establish an answering system when the program is closed which provides direct contact or call back by a staff member capable of addressing emergency patient issues; and</text> </paragraph> <paragraph num="(3)"> <text>Complete an individualized treatment plan which is described in COMAR 10.47.01.04 as follows:</text> <paragraph num="(a)"> <text>Completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment;</text> </paragraph> <paragraph num="(b)"> <text>Updated every 90 days for the first year of treatment; and</text> </paragraph> <paragraph num="(c)"> <text>After completion of 1 year of continuous treatment and if the patient meets the requirements for unsupervised or take home use set forth in CFR 42 §8.12(i), the individualized treatment plan may be updated every 180 days and signed by the alcohol and drug counselor and patient.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Random Drug Testing. The program shall:</text> <paragraph num="(1)"> <text>Conduct random drug testing on each patient at least monthly, in accordance with State law;</text> </paragraph> <paragraph num="(2)"> <text>Conduct random drug testing at a minimum for the following substances:</text> <paragraph num="(a)"> <text>Benzodiazepines;</text> </paragraph> <paragraph num="(b)"> <text>Marijuana;</text> </paragraph> <paragraph num="(c)"> <text>Cocaine;</text> </paragraph> <paragraph num="(d)"> <text>Opiates;</text> </paragraph> <paragraph num="(e)"> <text>Alcohol; and</text> </paragraph> <paragraph num="(f)"> <text>Methadone;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensure that positive screens are validated using federally approved, State-certified laboratories;</text> </paragraph> <paragraph num="(4)"> <text>If appropriate, use temperature sensitive cups in place of direct observation; and</text> </paragraph> <paragraph num="(5)"> <text>Develop procedures, approved by the Administration, that mandate clinical intervention if a patient's drug test result indicates substance use.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Dosage. The program shall:</text> <paragraph num="(1)"> <text>Maintain patients with a dose adequate to alleviate all withdrawal symptoms;</text> </paragraph> <paragraph num="(2)"> <text>Employ dose increases and behavior therapy before mandatory detoxification for patients continuing to use drugs;</text> </paragraph> <paragraph num="(3)"> <text>Establish patient dosing on an individual need;</text> </paragraph> <paragraph num="(4)"> <text>Provide flexible dosage tapering at patient request; and</text> </paragraph> <paragraph num="(5)"> <text>Develop a detoxification schedule at least 21 days long with daily dosage reductions less than 5 percent of the original total dose, regardless of the patient's ability to pay.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Opioid maintenance programs shall arrange for transportation of medication to and from the following levels of care:</text> <paragraph num="(1)"> <text>Residential treatment at Levels III.3, III.5, and III.7, as described in Regulations .07 — .09 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Detoxification services at Level III.2-D and III.7-D, as described in Regulation .10 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Residential treatment at Level III.1, when the patient cannot obtain or transport his or her own take-home opioid maintenance medication because of developmental or physical disabilities or because the patient does not have access to transportation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Opioid maintenance programs may transfer care of a patient to a closer opioid maintenance program when the patient is also being treated at a residential program or for detoxification services in a different county or jurisdiction.</text> </paragraph> <paragraph num="I."> <text>Programs may administratively detoxify or transfer a patient only if the:</text> <paragraph num="(1)"> <text>Patient's behavior on program premises is abusive, violent, or illegal;</text> </paragraph> <paragraph num="(2)"> <text>Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions including detoxification;</text> </paragraph> <paragraph num="(3)"> <text>Patient misses 3 consecutive medication days, and the program physician after a reevaluation has determined that administrative detoxification is warranted; or</text> </paragraph> <paragraph num="(4)"> <text>Clinical staff documents therapeutic reasons for detoxification, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Criteria for Take-Home Privileges. Before the patient may take home any dose the patient shall:</text> <paragraph num="(1)"> <text>Meet the criteria set within 42 CFR Part 8; and</text> </paragraph> <paragraph num="(2)"> <text>Provide the program with a working lock box for the take-home medication.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Referral Services. Programs shall:</text> <paragraph num="(1)"> <text>Provide referral services as required by the level of treatment under which the program is certified; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain a listing of agency referral agreements for the services.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 4, 1985 (12:22 Md. R. 2107)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11, DWI Program Protocols, repealed and new Regulations .01—.11, Specific Program Requirements, adopted effective June 10, 2002 (29:11 Md. R. 882)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="03" heading="Specific Program Requirements for Correctional Levels of Care"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter sets forth:</text> <paragraph num="(1)"> <text>Additional requirements that a program shall meet to be certified to offer the correctional levels of care; and</text> </paragraph> <paragraph num="(2)"> <text>Requirement exemptions for a program certified as a correctional level of care, which shall meet the requirements of COMAR 10.47.01 and 10.47.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Correctional levels are exempt from the following requirements of COMAR 10.47.01:</text> <paragraph num="(1)"> <text>COMAR 10.47.01.03C(2)(h), if the correctional facility's requirements are more stringent;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.47.01.04A(1)(a) and (b);</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.47.01.04E(2);</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.47.01.07A(1)(e); and</text> </paragraph> <paragraph num="(5)"> <text>COMAR 10.47.01.09.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings stated in COMAR 10.47.01.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Correctional Level I."> <paragraph num="A."> <text>Program Description.</text> <paragraph num="(1)"> <text>The program shall provide evaluation and treatment to patients who require services for less than 9 hours weekly in a correctional facility.</text> </paragraph> <paragraph num="(2)"> <text>Inmates receiving treatment may be housed throughout the correctional facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Inmates who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level I, or its equivalent as approved by the Administration, for the 30 days before incarceration; and</text> </paragraph> <paragraph num="(2)"> <text>Have a physical and emotional status that allows the inmate to function in the inmate's usual environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 30 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 90 days in accordance with the following:</text> <paragraph num="(a)"> <text>The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or</text> </paragraph> <paragraph num="(b)"> <text>If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(i)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(ii)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(iii)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director or clinical supervisor's documentation of the delay;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Case management services; and</text> </paragraph> <paragraph num="(4)"> <text>Group or individual counseling sessions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. The clinical staff person providing the service shall:</text> <paragraph num="(1)"> <text>Write a patient progress note after each counseling session; and</text> </paragraph> <paragraph num="(2)"> <text>Place the note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution:</text> <paragraph num="(1)"> <text>Medical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Correctional Level II.1."> <paragraph num="A."> <text>Program Description.</text> <paragraph num="(1)"> <text>A program shall provide structured evaluation and treatment to patients who require services from 9 to 20 hours weekly in a correctional facility.</text> </paragraph> <paragraph num="(2)"> <text>Inmates receiving treatment may be housed throughout the institution.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Inmates who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level II.1, or its equivalent as approved by the Administration, for the 30 days before incarceration; and</text> </paragraph> <paragraph num="(2)"> <text>Have a physical and emotional status that allows the inmate to function in the inmate's usual environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 30 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 30 days in accordance with the following:</text> <paragraph num="(a)"> <text>The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or</text> </paragraph> <paragraph num="(b)"> <text>If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(i)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(ii)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(iii)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 3 working days of the clinical director's or clinical supervisor's documentation of the delay;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Case management services;</text> </paragraph> <paragraph num="(4)"> <text>At least one group counseling session a week; and</text> </paragraph> <paragraph num="(5)"> <text>At least one individual session every 2 weeks.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff person shall:</text> <paragraph num="(1)"> <text>Write a patient progress note at the end of each week that services are provided; and</text> </paragraph> <paragraph num="(2)"> <text>Place the progress note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution:</text> <paragraph num="(1)"> <text>Medical services;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Correctional Level II.5."> <paragraph num="A."> <text>Program Description.</text> <paragraph num="(1)"> <text>A program shall provide structured evaluation and treatment to patients who require programming from 20 to 35 hours weekly in a correctional facility.</text> </paragraph> <paragraph num="(2)"> <text>Inmates receiving treatment may be housed together in a separate unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Inmates who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level II.5, or its equivalent as approved by the Administration, for the 30 days before incarceration; and</text> </paragraph> <paragraph num="(2)"> <text>Have a physical and emotional status that allows the inmate to function in the inmate's usual environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 30 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 30 days in accordance with the following:</text> <paragraph num="(a)"> <text>The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or</text> </paragraph> <paragraph num="(b)"> <text>If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(i)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(ii)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(iii)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 3 working days of the clinical director's or clinical supervisor's documentation of the delay;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Case management services;</text> </paragraph> <paragraph num="(4)"> <text>At least one group counseling session a week; and</text> </paragraph> <paragraph num="(5)"> <text>At least one individual session every 2 weeks.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff person shall:</text> <paragraph num="(1)"> <text>Write a patient progress note at the end of each week that services are provided; and</text> </paragraph> <paragraph num="(2)"> <text>Place the progress note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution:</text> <paragraph num="(1)"> <text>Medical services;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Correctional Level III.1."> <paragraph num="A."> <text>Program Description.</text> <paragraph num="(1)"> <text>A program shall offer treatment services at least 5 hours a week directed toward preventing relapse, applying recovery skills, promoting personal responsibility, and reintegration into the community.</text> </paragraph> <paragraph num="(2)"> <text>Inmates receiving this level of treatment shall be housed:</text> <paragraph num="(a)"> <text>Together in a prerelease center or a correctional halfway house; and</text> </paragraph> <paragraph num="(b)"> <text>Separately from inmates not receiving this level of treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Inmates who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.1, or its equivalent as approved by the Administration, for the 30 days before incarceration; and</text> </paragraph> <paragraph num="(2)"> <text>Be capable of self care but not ready to return to independent living.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>A correctional Level III.1 program shall employ:</text> <paragraph num="(a)"> <text>One individual as clinical supervisor, who may also be the program's administrator; and</text> </paragraph> <paragraph num="(b)"> <text>At least one staff member to be on duty at all times.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staff may not dispense medications.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A correctional Level III.1 program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 30 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 60 days in accordance with the following:</text> <paragraph num="(a)"> <text>The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or</text> </paragraph> <paragraph num="(b)"> <text>If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(i)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(ii)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(iii)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director's or clinical supervisor's documentation of the delay;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Periodic group counseling that focuses on relapse prevention;</text> </paragraph> <paragraph num="(4)"> <text>Case management services;</text> </paragraph> <paragraph num="(5)"> <text>Individual counseling, at least monthly; and</text> </paragraph> <paragraph num="(6)"> <text>Leisure and recreational activities.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. The clinical staff person providing the service shall:</text> <paragraph num="(1)"> <text>Write a patient progress note after each counseling session; and</text> </paragraph> <paragraph num="(2)"> <text>Place the note in the patient's record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution:</text> <paragraph num="(1)"> <text>Medical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Legal assistance;</text> </paragraph> <paragraph num="(6)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(7)"> <text>Social services; and</text> </paragraph> <paragraph num="(8)"> <text>Education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Correctional Level III.5."> <paragraph num="A."> <text>Program Description. A correctional Level III.5 program:</text> <paragraph num="(1)"> <text>Shall provide a highly structured environment in combination with moderate to high intensity treatment and ancillary services to support and promote recovery;</text> </paragraph> <paragraph num="(2)"> <text>Shall be characterized by its reliance on the treatment community as a therapeutic agent; and</text> </paragraph> <paragraph num="(3)"> <text>May not allow a structure whereby inmates have authority over one another.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Inmates who are appropriate for this level of treatment shall:</text> <paragraph num="(1)"> <text>Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.5, or its equivalent as approved by the Administration, for the 30 days before incarceration; and</text> </paragraph> <paragraph num="(2)"> <text>Be housed separately from inmates not receiving this level of treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Staffing.</text> <paragraph num="(1)"> <text>Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06.</text> </paragraph> <paragraph num="(2)"> <text>A program shall have sufficient medical services to:</text> <paragraph num="(a)"> <text>Provide initial diagnostic work-up;</text> </paragraph> <paragraph num="(b)"> <text>Provide identification of medical and surgical problems for referral; and</text> </paragraph> <paragraph num="(c)"> <text>Handle medical emergencies when necessary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Program Services. A program shall provide the following services:</text> <paragraph num="(1)"> <text>An assessment as described in COMAR 10.47.01.04 within 2 days of admission;</text> </paragraph> <paragraph num="(2)"> <text>An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update every 30 days in accordance with the following:</text> <paragraph num="(a)"> <text>The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or</text> </paragraph> <paragraph num="(b)"> <text>If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall:</text> <paragraph num="(i)"> <text>Determine the reason for a delay in development of a treatment plan;</text> </paragraph> <paragraph num="(ii)"> <text>Document the reason in the patient's record; and</text> </paragraph> <paragraph num="(iii)"> <text>Direct an appropriate clinical staff person to develop a treatment plan within 2 working days of the clinical director's or clinical supervisor's documentation of the delay; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A minimum of 36 hours of therapeutic activities a week, including but not limited to:</text> <paragraph num="(a)"> <text>One individual counseling session a week;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Alcohol and drug education;</text> </paragraph> <paragraph num="(d)"> <text>Career counseling; and</text> </paragraph> <paragraph num="(e)"> <text>Nutrition education.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation. A designated clinical staff person shall write a patient progress note at the end of each week that services are provided and place the progress note in the patient's record.</text> </paragraph> <paragraph num="F."> <text>Referral Services. At the time of the patient's release from the institution, the program shall have available through referral the following:</text> <paragraph num="(1)"> <text>Medical care;</text> </paragraph> <paragraph num="(2)"> <text>Services through the Division of Rehabilitation Services;</text> </paragraph> <paragraph num="(3)"> <text>Vocational assistance;</text> </paragraph> <paragraph num="(4)"> <text>Mental health services;</text> </paragraph> <paragraph num="(5)"> <text>Substance abuse treatment programs;</text> </paragraph> <paragraph num="(6)"> <text>Legal assistance; and</text> </paragraph> <paragraph num="(7)"> <text>Social services.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.47.03, Certification Requirements, recodified to be COMAR 10.47.04 and new chapter, Specific Program Requirements for Correctional Levels of Care, adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> </annotations> </chapter> <chapter num="04" heading="Certification Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth additional requirements that a program shall meet to be certified to offer a particular level of treatment. The program shall meet the requirements of COMAR 10.47.01 and this chapter.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, terms have the meanings stated in COMAR 10.47.01.02.</text> </paragraph> <paragraph num="B."> <text>In addition to terms referenced under §A of this regulation, in this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="C."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Deficiency” means a failure to meet a regulation or its intent.</text> </paragraph> <paragraph num="(2)"> <text>“Plan of correction” means the program's proposed response to findings of noncompliance identified by the Office of Health Care Quality or the Administration.</text> </paragraph> <paragraph num="(3)"> <text>“Sale” means the transfer of a majority interest of ownership.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Certification Required."> <paragraph num="A."> <text>All programs and prevention programs shall be certified by the Department before program services and prevention program services may be provided in the State.</text> </paragraph> <paragraph num="B."> <text>The following are exempt from certification under this chapter:</text> <paragraph num="(1)"> <text>A health professional licensed under the Health Occupations Article who is treating patients within the scope of the professional's practice and who does not advertise the practice as an alcohol abuse or drug abuse program;</text> </paragraph> <paragraph num="(2)"> <text>Alcoholics Anonymous, Narcotics Anonymous, transitional housing programs, or other similar organizations, if the organization holds meetings or provides support services to help individuals who show the effects of drug abuse or alcohol abuse;</text> </paragraph> <paragraph num="(3)"> <text>An employees' assistance program of a business entity; and</text> </paragraph> <paragraph num="(4)"> <text>A hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland, accredited by the Joint Commission on Accreditation of Health Care Organizations with a separately accredited alcohol and drug abuse program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All programs offering drug and alcohol treatment, care, and rehabilitation are required to be certified except as in §A of this regulation.</text> </paragraph> <paragraph num="D."> <text>Each level of service offered by a program requires a certification.</text> </paragraph> <paragraph num="E."> <text>A separate certification is required for each physical site regardless of the service.</text> </paragraph> <paragraph num="F."> <text>A certification is valid only for the program to which it is issued and is not subject to voluntary or involuntary sale, assignment, or transfer.</text> </paragraph> <paragraph num="G."> <text>Upon sale, transfer, assignment, lease, or relocation, the program shall obtain a new certification.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Type and Duration of Certification."> <paragraph num="A."> <text>Initial Certification.</text> <paragraph num="(1)"> <text>After receipt of the completed written or electronic application provided by the Administration and after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant an initial certification.</text> </paragraph> <paragraph num="(2)"> <text>The initial certification is valid for a period in the discretion of the Administration, not to exceed 6 months.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provisional Certification.</text> <paragraph num="(1)"> <text>After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, and, if there are deficiencies which are not life threatening, the Administration, with the program's consent, may grant a provisional certification to permit the program to correct its deficiencies as set forth in its plan of correction.</text> </paragraph> <paragraph num="(2)"> <text>If upon review of a written or electronic renewal application provided by the Administration, the Office of Health Care Quality finds deficiencies which are not life threatening, the Administration may grant a provisional certification to permit the program to correct the deficiencies as set forth in the plan of correction.</text> </paragraph> <paragraph num="(3)"> <text>A provisional certification is valid for a period in the discretion of the Administration, not to exceed 6 months, and may be issued once.</text> </paragraph> </paragraph> <paragraph num="C."> <text>General Certification.</text> <paragraph num="(1)"> <text>After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant the program a general certification.</text> </paragraph> <paragraph num="(2)"> <text>A general certification is valid for 2 years from date of issue.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Surrender of Certification. A program shall surrender its certificate to the Administration on:</text> <paragraph num="(1)"> <text>Revocation of the program's certification by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Sale of the program;</text> </paragraph> <paragraph num="(3)"> <text>Transfer of the program;</text> </paragraph> <paragraph num="(4)"> <text>Assignment of the program;</text> </paragraph> <paragraph num="(5)"> <text>Lease of the program;</text> </paragraph> <paragraph num="(6)"> <text>Relocation of the program; or</text> </paragraph> <paragraph num="(7)"> <text>Voluntary decision to close the program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Process and Evaluation."> <paragraph num="A."> <text>Application. An applicant for certification of a program or renewal of certification shall submit to the Office of Health Care Quality:</text> <paragraph num="(1)"> <text>A completed application on a written or electronic form approved by the Administration;</text> </paragraph> <paragraph num="(2)"> <text>Documentation of:</text> <paragraph num="(a)"> <text>The program service plan;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory fire, safety, and health inspection reports; and</text> </paragraph> <paragraph num="(c)"> <text>Compliance with COMAR 10.47.01 and the applicable specific program requirements under COMAR 10.47.02;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A request for a variance or a waiver of a regulation; and</text> </paragraph> <paragraph num="(4)"> <text>An application fee of $700 with initial application and at recertification, if the program provides opioid maintenance therapy as described in COMAR 10.47.02.11.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Incomplete Application or Information.</text> <paragraph num="(1)"> <text>After reviewing the application, if the Office of Health Care Quality or the Administration finds it needs more information, the Office of Health Care Quality or the Administration shall request the information in writing.</text> </paragraph> <paragraph num="(2)"> <text>The application shall remain open for 6 months after the information is requested. If the program does not provide the requested information, the Office of Health Care Quality shall close the application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Initial Site Visit and Written Report.</text> <paragraph num="(1)"> <text>On receipt of a completed application under this regulation and the required documentation, the Office of Health Care Quality shall conduct a site visit and issue a written report. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a written plan of correction within 15 working days.</text> </paragraph> <paragraph num="(2)"> <text>Deficiencies in a New Program. If a new program with deficiencies:</text> <paragraph num="(a)"> <text>Fails to submit a plan of correction, the Office of Health Care Quality shall considered the application withdrawn; or</text> </paragraph> <paragraph num="(b)"> <text>Submits a plan of correction that the Office of Health Care Quality believes:</text> <paragraph num="(i)"> <text>Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program initial certification; or</text> </paragraph> <paragraph num="(ii)"> <text>Does not correct the deficiencies, the Office of Health Care Quality may issue a denial or permit the program to submit an additional plan of correction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Deficiencies in a Program Being Renewed. If a renewal program with deficiencies:</text> <paragraph num="(a)"> <text>Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or</text> </paragraph> <paragraph num="(b)"> <text>Submits a plan of correction which the Office of Health Care Quality believes:</text> <paragraph num="(i)"> <text>Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification;</text> </paragraph> <paragraph num="(ii)"> <text>Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or</text> </paragraph> <paragraph num="(iii)"> <text>Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall:</text> <paragraph num="(a)"> <text>For new applicants, recommend an initial certification; and</text> </paragraph> <paragraph num="(b)"> <text>For renewal applicants, recommend general certification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Site Visit and Written Report After Issuing Initial or Provisional Certificate.</text> <paragraph num="(1)"> <text>Within 4 months after the issuance of an initial certification or provisional certification, the Office of Health Care Quality shall conduct a site visit and submit a written report.</text> </paragraph> <paragraph num="(2)"> <text>Deficiencies in a Program with Initial Certification. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a plan of correction within 15 days. If the program:</text> <paragraph num="(a)"> <text>Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or</text> </paragraph> <paragraph num="(b)"> <text>Submits a plan of correction which the Office of Health Care Quality believes:</text> <paragraph num="(i)"> <text>Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification;</text> </paragraph> <paragraph num="(ii)"> <text>Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or</text> </paragraph> <paragraph num="(iii)"> <text>Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Deficiencies in a Program with Provisional Certification. The Office of Health Care Quality shall:</text> <paragraph num="(a)"> <text>For good cause, permit the program to submit a plan of correction within 15 days and follow §C(1) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Recommend disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall recommend a general certification.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In considering a renewal application, the Administration may accept accreditation of the program by an accreditation organization approved in accordance with Health-General Article, §19-2302(a) and (b), Annotated Code of Maryland, in lieu of the site visit and written report by the Office of Health Care Quality that is otherwise required by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Waiver and Variances."> <paragraph num="A."> <text>Upon written request by the program, the Director shall issue a written decision which may:</text> <paragraph num="(1)"> <text>Grant a variance or waiver from a regulation if the:</text> <paragraph num="(a)"> <text>Variance or waiver would not endanger the life or safety of a patient in a program; or</text> </paragraph> <paragraph num="(b)"> <text>Intent of the regulation to which a variance or waiver is sought meets the alternative proposed by the program; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Deny the variance or waiver.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Director may grant a variance or waiver that:</text> <paragraph num="(1)"> <text>Remains in effect for as long as the program continues to comply with the conditions under which the variance or waiver is granted; or</text> </paragraph> <paragraph num="(2)"> <text>Is time limited.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program is responsible for maintaining a copy of the decision in its certification file.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Investigation or Inspection by the Administration or Office of Health Care Quality."> <paragraph num="A."> <text>A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Administration or its designees.</text> </paragraph> <paragraph num="B."> <text>A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Office of Health Care Quality.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Denial, Probation, Intermediate Sanctions, Suspension, or Revocation."> <paragraph num="A."> <text>If an applicant or program fails to comply with the applicable State and federal laws, rules, or regulations, the Director may:</text> <paragraph num="(1)"> <text>Deny approval to the applicant; or</text> </paragraph> <paragraph num="(2)"> <text>Take disciplinary action, such as:</text> <paragraph num="(a)"> <text>Placing the program on probation;</text> </paragraph> <paragraph num="(b)"> <text>Suspending or revoking the certification of the program; or</text> </paragraph> <paragraph num="(c)"> <text>Imposing intermediate sanctions on the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For purposes of §A of this regulation, intermediate sanctions include:</text> <paragraph num="(1)"> <text>A directed plan of correction, if the program is directed to take a specific action by a certain date;</text> </paragraph> <paragraph num="(2)"> <text>A mandatory staffing pattern that is stricter than that required under the appropriate level of care required under COMAR 10.47.02, if the Administration defines for the program the level of individual supervision;</text> </paragraph> <paragraph num="(3)"> <text>Mandatory training, if the Administration identifies deficient areas in which training is needed;</text> </paragraph> <paragraph num="(4)"> <text>Patient relocation, if the Administration reserves the right to relocate a patient to another program in order to protect the health and safety of the patient;</text> </paragraph> <paragraph num="(5)"> <text>Expansion ban, if the Administration retains the authority to prohibit the program from obtaining additional sites, admitting individuals, or providing additional services at the site;</text> </paragraph> <paragraph num="(6)"> <text>Imposition of an intensive monitoring protocol by the Administration; or</text> </paragraph> <paragraph num="(7)"> <text>Imposition of a temporary site monitor, if the Administration maintains an ongoing physical presence for the purpose of providing assistance and evaluating the extent of the program's corrective actions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Director proposes to deny approval to an applicant or to take disciplinary action against a program, the Director shall give written notice to the governing body or the health officer and the administrator of the program.</text> </paragraph> <paragraph num="D."> <text>In the written notice under §C of this regulation, the Director shall include:</text> <paragraph num="(1)"> <text>The statutory and regulatory authority upon which the proposed action is based;</text> </paragraph> <paragraph num="(2)"> <text>The facts supporting the alleged violation of law; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant's or program's right to a hearing before final action under §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Summary Suspension.</text> <paragraph num="(1)"> <text>Under the State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a predeprivation hearing, the Director may summarily order the suspension of a certification if the Administration finds that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="(2)"> <text>The Director shall notify the program in writing of the suspension, findings, and reasons that support the findings, and, if appropriate, the opportunity for a predeprivation hearing. The notice shall include:</text> <paragraph num="(a)"> <text>The proposed order for summary suspension which includes:</text> <paragraph num="(i)"> <text>The statutory and regulatory authority upon which the order is based;</text> </paragraph> <paragraph num="(ii)"> <text>The facts supporting the alleged violations of law;</text> </paragraph> <paragraph num="(iii)"> <text>The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals; and</text> </paragraph> <paragraph num="(iv)"> <text>The program's right to appeal the summary suspension, if executed by the Director; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A show cause notice providing an opportunity for the program to show cause as to why an order under §C(1) of this regulation should not be issued.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Director may suspend an approval without prior notice and the opportunity to be heard if:</text> <paragraph num="(a)"> <text>The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension;</text> </paragraph> <paragraph num="(b)"> <text>Notice of an opportunity to be heard before the action is not feasible; and</text> </paragraph> <paragraph num="(c)"> <text>The Administration provides the program with a post-deprivation hearing opportunity within 15 working days of the suspension.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Administration shall:</text> <paragraph num="(a)"> <text>Notify the individuals being served by the program and, if appropriate, their families or proponents, regarding the summary suspension; and</text> </paragraph> <paragraph num="(b)"> <text>Assist the individuals in finding alternative services if the approval is summarily suspended.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures for Hearings.</text> <paragraph num="(1)"> <text>If the Director proposes to deny an approval or take disciplinary action against a program, the Director shall give the program written notice according to §D of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 working days of receipt of the notice, the governing body or health officer may file a written request for a hearing with the Office of Administrative Hearings and send copies of the request to the:</text> <paragraph num="(a)"> <text>Director; and</text> </paragraph> <paragraph num="(b)"> <text>Administrative prosecutor.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the governing body or the health officer does not file a request for a hearing within 10 working days of receipt of the notification, the:</text> <paragraph num="(a)"> <text>Program waives its right to request a hearing; and</text> </paragraph> <paragraph num="(b)"> <text>Director may implement the proposed action.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a timely request for a hearing has been received, the Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Notify the Director, the governing body or health officer, and administrative prosecutor of the date, time, and location of the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Director shall issue a final decision and send notice to the governing body or the health officer.</text> </paragraph> <paragraph num="(6)"> <text>A program may appeal any final decision from a contested case by following the provisions of Health-General Article, §2-207, Annotated Code of Maryland, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>In addition to disposing of a case by a hearing, the Director may dispose of a contested case by:</text> <paragraph num="(a)"> <text>Stipulation;</text> </paragraph> <paragraph num="(b)"> <text>Settlement;</text> </paragraph> <paragraph num="(c)"> <text>Consent order;</text> </paragraph> <paragraph num="(d)"> <text>Default;</text> </paragraph> <paragraph num="(e)"> <text>Withdrawal;</text> </paragraph> <paragraph num="(f)"> <text>Summary disposition; or</text> </paragraph> <paragraph num="(g)"> <text>Dismissal.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-205, 8-401 — 8-405, and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 10, 2002 (29:11 Md. R. 882)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.47.03 to 10.47.04 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective November 24, 2014 (41:23 Md. R. 1374)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 recodified to be Regulation .08 and new Regulation .07 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> </annotations> </chapter> <chapter num="05" heading="Education Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth additional requirements that a program shall meet as a private or public education program for individuals convicted under Transportation Article, §21-902, Annotated Code of Maryland, and ordered to attend an education program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>In this chapter, terms have the meanings set forth in COMAR 10.47.01.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Process and Evaluation."> <paragraph num="A."> <text>The applicant shall complete an application on a form approved by the Administration and submit the application and documentation to indicate the applicant is in compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>After the Administration receives the application the Administration shall:</text> <paragraph num="(1)"> <text>Return the application if it is incomplete; or</text> </paragraph> <paragraph num="(2)"> <text>Arrange a site visit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After the site visit, the Administration shall</text> <paragraph num="(1)"> <text>Grant approval;</text> </paragraph> <paragraph num="(2)"> <text>Grant approval with conditions; or</text> </paragraph> <paragraph num="(3)"> <text>Deny approval.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Program Requirements."> <text>The program shall:</text> <paragraph num="A."> <text>Comply with COMAR 10.47.01 and 10.47.02.03;</text> </paragraph> <paragraph num="B."> <text>At minimum, offer six weekly 2-hour sessions for a total of 12 hours;</text> </paragraph> <paragraph num="C."> <text>Have instructors approved by the Administration who are:</text> <paragraph num="(1)"> <text>Instructors before October 1, 2002; or</text> </paragraph> <paragraph num="(2)"> <text>At a minimum, certified as a Certified Supervised Counselor-Alcohol and Drug, as defined by Health Occupations Article, Title 17, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ensure that staff is appropriately credentialed and privileged to teach the curriculum;</text> </paragraph> <paragraph num="E."> <text>Teach the Administration's curriculum or an equivalent curriculum approved by the Administration, which covers:</text> <paragraph num="(1)"> <text>Scope of drinking-driver problem;</text> </paragraph> <paragraph num="(2)"> <text>Drinking driver patterns and characteristics;</text> </paragraph> <paragraph num="(3)"> <text>The pharmacology of substance abuse;</text> </paragraph> <paragraph num="(4)"> <text>The process of addiction to drugs and alcohol;</text> </paragraph> <paragraph num="(5)"> <text>The relationship of substance use to crime, health, family, and other social problems; and</text> </paragraph> <paragraph num="(6)"> <text>Treatment resources; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Report to the court or probation agent as specified by the court order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial, Probation, Intermediate Sanctions, Suspension, or Revocation."> <paragraph num="A."> <text>If an applicant or Program fails to comply with the applicable State and federal laws, rules, or regulations, the Director may:</text> <paragraph num="(1)"> <text>Deny approval to the applicant; or</text> </paragraph> <paragraph num="(2)"> <text>Take disciplinary action, such as:</text> <paragraph num="(a)"> <text>Placing the program on probation;</text> </paragraph> <paragraph num="(b)"> <text>Suspending or revoking the certification of the program; or</text> </paragraph> <paragraph num="(c)"> <text>Imposing intermediate sanctions on the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For purposes of §A of this regulation, intermediate sanctions include:</text> <paragraph num="(1)"> <text>A directed plan of correction, if the program is directed to take a specific action by a certain date;</text> </paragraph> <paragraph num="(2)"> <text>A mandatory staffing pattern that is stricter than that required under the appropriate level of care in these regulations, if the Administration defines for the program the level of individual supervision;</text> </paragraph> <paragraph num="(3)"> <text>Mandatory training, if the Administration identifies deficient areas in which training is needed;</text> </paragraph> <paragraph num="(4)"> <text>Expansion ban, if the Administration retains the authority to prohibit the program from obtaining additional sites, admitting individuals, or providing additional services at the site;</text> </paragraph> <paragraph num="(5)"> <text>Imposition of an intensive monitoring protocol by the Administration; or</text> </paragraph> <paragraph num="(6)"> <text>Imposition of a temporary site monitor, if the Administration maintains an ongoing physical presence for the purpose of providing assistance and evaluating the extent of the program's corrective actions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Director proposes to deny approval to an applicant or to take disciplinary action against a program, the Director shall give written notice to the health officer or executive director of the program.</text> </paragraph> <paragraph num="D."> <text>In the written notice under §C of this regulation, the Director shall include:</text> <paragraph num="(1)"> <text>The statutory and regulatory authority upon which the proposed action is based;</text> </paragraph> <paragraph num="(2)"> <text>The facts supporting the alleged violation of law; and</text> </paragraph> <paragraph num="(3)"> <text>The applicant's or program's right to a hearing before final action under §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Summary Suspension.</text> <paragraph num="(1)"> <text>Under the State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a predeprivation hearing, the Director may summarily order the suspension of the approval if the Administration finds that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="(2)"> <text>The Director shall notify the program in writing of the suspension, findings, and reasons that support the findings, and, if appropriate, the opportunity for a predeprivation hearing. The notice shall include:</text> <paragraph num="(a)"> <text>The proposed order for summary suspension which includes:</text> <paragraph num="(i)"> <text>The statutory and regulatory authority upon which the order is based;</text> </paragraph> <paragraph num="(ii)"> <text>The facts supporting the alleged violations of law;</text> </paragraph> <paragraph num="(iii)"> <text>The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals; and</text> </paragraph> <paragraph num="(iv)"> <text>The program's right to appeal the summary suspension, if executed by the Director; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A show cause notice providing an opportunity for the program to show cause as to why the order may not be issued if the public health, safety, and welfare permits.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Director may suspend approval without prior notice and the opportunity to be heard if:</text> <paragraph num="(a)"> <text>The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension;</text> </paragraph> <paragraph num="(b)"> <text>Notice of an opportunity to be heard before the action is not feasible; and</text> </paragraph> <paragraph num="(c)"> <text>The Administration provides the program with a post-deprivation hearing opportunity within 15 working days of the suspension.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures for Hearings.</text> <paragraph num="(1)"> <text>If the Director proposes to deny an approval or take disciplinary action against a program, the Director shall give the program written notice according to §C of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Within 10 working days of receipt of the notice, the executive director or health officer may file a written request for a hearing with the Office of Administrative Hearings and send copies of the request to the:</text> <paragraph num="(a)"> <text>Director; and</text> </paragraph> <paragraph num="(b)"> <text>Administrative prosecutor.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the executive director or health officer does not file a request for a hearing within 10 working days of receipt of the notification, the:</text> <paragraph num="(a)"> <text>Program waives its right to request a hearing; and</text> </paragraph> <paragraph num="(b)"> <text>Director may implement the proposed action.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a timely request for a hearing has been received, the Office of Administrative Hearings shall:</text> <paragraph num="(a)"> <text>Notify the Director, the executive director or health officer, and administrative prosecutor of the date, time, and location of the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Director shall issue a final decision and send notice to the governing body or the health officer.</text> </paragraph> <paragraph num="(6)"> <text>A program may appeal any final decision from a contested case by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>In addition to disposing of a case by a hearing, the Director may dispose of a contested case by:</text> <paragraph num="(a)"> <text>Stipulation;</text> </paragraph> <paragraph num="(b)"> <text>Settlement;</text> </paragraph> <paragraph num="(c)"> <text>Consent order;</text> </paragraph> <paragraph num="(d)"> <text>Default;</text> </paragraph> <paragraph num="(e)"> <text>Withdrawal;</text> </paragraph> <paragraph num="(f)"> <text>Summary disposition; or</text> </paragraph> <paragraph num="(g)"> <text>Dismissal.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 10, 2002 (29:11 Md. R. 882)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.47.04 to 10.47.05 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> </annotations> </chapter> <chapter num="06" heading="Substance Abuse Treatment Outcomes Partnerships — (S.T.O.P.) Fund"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter specifies the requirements for applying for funding from the Substance Abuse Treatment Outcomes Partnership Fund. This chapter establishes time lines and procedures for requests for partnership funding, guidelines that require programs to bill third-party insurers, and fund management including, but not limited to, authorization of distribution of money.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Eligible functions” means:</text> <paragraph num="(a)"> <text>Transportation to and from treatment services;</text> </paragraph> <paragraph num="(b)"> <text>Treatment, prevention, or coordination staff;</text> </paragraph> <paragraph num="(c)"> <text>Data sharing services among counties and other appropriate treatment providers;</text> </paragraph> <paragraph num="(d)"> <text>Education or outreach programs and materials;</text> </paragraph> <paragraph num="(e)"> <text>In-community emergency behavioral health services or crisis stabilization units; or</text> </paragraph> <paragraph num="(f)"> <text>Behavioral health programs in schools.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Eligible population” means:</text> <paragraph num="(a)"> <text>Mothers of drug-addicted infants;</text> </paragraph> <paragraph num="(b)"> <text>Parents of children in need of assistance;</text> </paragraph> <paragraph num="(c)"> <text>Hospital emergency room admittees;</text> </paragraph> <paragraph num="(d)"> <text>Needy families receiving temporary cash assistance;</text> </paragraph> <paragraph num="(e)"> <text>Foster care children and parents;</text> </paragraph> <paragraph num="(f)"> <text>Children in after-school programs and their parents, including children and parents in programs supported by the Maryland After-School Opportunity Fund;</text> </paragraph> <paragraph num="(g)"> <text>Adolescents;</text> </paragraph> <paragraph num="(h)"> <text>Parents subject to arrearages in child support payments;</text> </paragraph> <paragraph num="(i)"> <text>Drug offenders under the supervision of the Division of Parole and Probation;</text> </paragraph> <paragraph num="(j)"> <text>Pretrial correctional inmates;</text> </paragraph> <paragraph num="(k)"> <text>Prerelease correctional inmates;</text> </paragraph> <paragraph num="(l)"> <text>The general inmate population within county-managed correctional facilities;</text> </paragraph> <paragraph num="(m)"> <text>Parents of children entering out-of-home placements or at risk of entering out-of-home placements; or</text> </paragraph> <paragraph num="(n)"> <text>Drug offenders under the supervision of the problem solving courts.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Jurisdiction” means Baltimore City or one of the 23 counties in Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Partnership funding” means money granted from the Substance Abuse Treatment Outcomes Partnership Fund.</text> </paragraph> <paragraph num="(6)"> <text>“Proposal” means a plan under this chapter to provide new or expanded substance abuse treatment services.</text> </paragraph> <paragraph num="(7)"> <text>“Request for partnership funding” means:</text> <paragraph num="(a)"> <text>A proposal, submitted by the governing bodies of one or more jurisdictions, to provide substance-related disorder treatment services to one or more eligible populations; or</text> </paragraph> <paragraph num="(b)"> <text>To provide funding for eligible functions within the requesting jurisdiction or jurisdictions.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Task Force” means the Task Force to Study Increasing the Availability of Substance Abuse Programs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requests for Partnership Funding and Criteria for Awarding Funding."> <paragraph num="A."> <text>Requests for partnership funding may be submitted to the Department by:</text> <paragraph num="(1)"> <text>The governing body of a jurisdiction or its designee; or</text> </paragraph> <paragraph num="(2)"> <text>The governing bodies of more than one jurisdiction or their designee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Proposals shall include the following:</text> <paragraph num="(1)"> <text>Identification of one or more eligible populations per jurisdiction;</text> </paragraph> <paragraph num="(2)"> <text>Eligible functions that will be funded under the plan;</text> </paragraph> <paragraph num="(3)"> <text>A description of the plan to provide substance-related disorder services;</text> </paragraph> <paragraph num="(4)"> <text>Identification of local providers able to provide these services;</text> </paragraph> <paragraph num="(5)"> <text>A plan to reach the eligible populations using relevant means of contact;</text> </paragraph> <paragraph num="(6)"> <text>Performance and outcome indicators to evaluate the program effectiveness including a description of the expected schedule and methods for measuring performance and outcome;</text> </paragraph> <paragraph num="(7)"> <text>A plan to bill third-party insurers;</text> </paragraph> <paragraph num="(8)"> <text>A prepared annual expenditure plan which reflects all anticipated income including partnership funding, local, third party, and cash revenue to the partnership program; and</text> </paragraph> <paragraph num="(9)"> <text>A statement of the local cash match or local in-kind match, including but not limited to provision of space, staff, or services, that the applicant intends to commit to the effort.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Time Line. Requests for partnership funding shall be received by the Department by April 1 for the following fiscal year.</text> </paragraph> <paragraph num="D."> <text>The Department shall consider the following:</text> <paragraph num="(1)"> <text>Performance and outcome indicators specified;</text> </paragraph> <paragraph num="(2)"> <text>The degree to which the proposal may reduce the need for other State or local public services or programs intended for the populations targeted by the proposal;</text> </paragraph> <paragraph num="(3)"> <text>The extent to which the proposal incorporates the use of excess or otherwise available medical-related facilities, including vacant hospital beds;</text> </paragraph> <paragraph num="(4)"> <text>How the proposal fits into a balanced approach to the State’s variety of substance-related disorder needs and populations that serve different geographic areas of the State with partnership funding;</text> </paragraph> <paragraph num="(5)"> <text>The extent to which the proposal is part of or consistent with a regional strategy for substance-related disorder treatment programs affecting adjoining jurisdictions; and</text> </paragraph> <paragraph num="(6)"> <text>Other factors consistent with Health-General Article, §8-6C-04, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may specify in a request for proposals the types of treatment services that are eligible for funding awards.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Fiscal Responsibility by Jurisdiction."> <paragraph num="A."> <text>The Department may award partnership funding that results in a county being responsible for less than 1/2 of the cost of the approved partnership funding after considering:</text> <paragraph num="(1)"> <text>The financial hardship of the participating county;</text> </paragraph> <paragraph num="(2)"> <text>Prior and current contributions of funds for substance abuse treatment programs made by the participating county; and</text> </paragraph> <paragraph num="(3)"> <text>Other relevant considerations considered appropriate by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participating jurisdiction shall use partnership funding only to supplement levels of spending by the participating jurisdiction on drug treatment programs.</text> </paragraph> <paragraph num="C."> <text>A participating jurisdiction may not use partnership funding to supplant spending by the participating jurisdiction on drug treatment programs.</text> </paragraph> <paragraph num="D."> <text>A participating jurisdiction may use partnership funding to continue or expand funding for eligible functions if the participating jurisdiction began spending funds on eligible functions after October 1, 2010.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-6C-01 — 8-6C-04, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective January 30, 2001 (28:3 Md. R. 203); adopted permanently effective April 30, 2001 (28:8 Md. R. 762)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.47.03 to 10.47.05 effective June 10, 2002 (29:11 Md. R. 882)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from 10.47.05 to 10.47.06 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 15, 2016 (43:16 Md. R. 901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 15, 2016 (43:16 Md. R. 901)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective August 15, 2016 (43:16 Md. R. 901)</annotation> </annotations> </chapter> <chapter num="07" heading="Prescription Drug Monitoring Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the requirements for monitoring the prescribing and dispensing of controlled dangerous substances under the Prescription Drug Monitoring Program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Authorized user” means a licensed prescriber, a prescriber delegate, a licensed pharmacist, a pharmacist delegate, or a licensed health care practitioner registered with another state’s prescription drug monitoring program.</text> </paragraph> <paragraph num="(2)"> <text>“Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> <paragraph num="(3)"> <text>“Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland, but does not include:</text> <paragraph num="(a)"> <text>Directly administering a monitored prescription drug to a patient; or</text> </paragraph> <paragraph num="(b)"> <text>Giving a patient prescription drug samples in accordance with Health Occupations Article, §12-102(d), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Dispenser.</text> <paragraph num="(a)"> <text>“Dispenser” means person authorized by law to dispense a monitored prescription drug to a patient or a patient’s agent in the State, including a nonresident pharmacy so authorized.</text> </paragraph> <paragraph num="(b)"> <text>“Dispenser” does not include:</text> <paragraph num="(i)"> <text>A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;</text> </paragraph> <paragraph num="(ii)"> <text>An opioid treatment services program;</text> </paragraph> <paragraph num="(iii)"> <text>A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;</text> </paragraph> <paragraph num="(iv)"> <text>A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; or</text> </paragraph> <paragraph num="(v)"> <text>A pharmacy issued a waiver from reporting dispensing of monitored prescription drugs to hospice inpatients under Regulation .03G of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Existing bona fide individual investigation” means an active and good faith investigation of an identified prescriber, dispenser, or patient for possible violations falling under the jurisdiction of the requesting governmental unit or agency.</text> </paragraph> <paragraph num="(6)"> <text>“Existing bona fide investigation” means an active and good faith investigation of identified prescribers, dispensers, or patients for possible violations falling under the jurisdiction of the requesting governmental unit or agency.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed health care practitioner” means an individual who is:</text> <paragraph num="(a)"> <text>Licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or the laws of the practitioner’s respective state, as appropriate, to provide health care services; and</text> </paragraph> <paragraph num="(b)"> <text>Authorized by a prescriber or pharmacist to access prescription monitoring data in connection with the medical care of a patient to whom the prescriber prescribes or the pharmacist dispenses a monitored prescription drug.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Licensing entity” means an entity authorized under Health Occupations Article, Annotated Code of Maryland, to license, regulate, or discipline a prescriber or pharmacist.</text> </paragraph> <paragraph num="(9)"> <text>“Medical director” means an individual who is:</text> <paragraph num="(a)"> <text>A prescriber; and</text> </paragraph> <paragraph num="(b)"> <text>Employed by or under contract with a health care facility and serves as that facility’s chief medical officer or in an equivalent role.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Monitored Prescription Drug.</text> <paragraph num="(a)"> <text>“Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Monitored prescription drug” does not include naloxone medication.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Naloxone medication” means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose.</text> </paragraph> <paragraph num="(12)"> <text>“Naloxone medication data” means the information required to be submitted to the Program when dispensing naloxone medication</text> </paragraph> <paragraph num="(13)"> <text>“Office” means the Office of Controlled Substances Administration in the Department.</text> </paragraph> <paragraph num="(14)"> <text>“Opioid treatment services program” means a program that:</text> <paragraph num="(a)"> <text>Is certified by the State under Health-General Article, §8-401, Annotated Code of Maryland or licensed by the State under Health-General Article, §7.5-401, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;</text> </paragraph> <paragraph num="(c)"> <text>Complies with:</text> <paragraph num="(i)"> <text>The Code of Federal Regulations 42, Part 8;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.47.02.11; and</text> </paragraph> <paragraph num="(iii)"> <text>Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the State Division of Drug Control; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the Federal Center for Substance Abuse Treatment.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Patient” means:</text> <paragraph num="(a)"> <text>An individual for whom a prescriber has prescribed or is considering prescribing a monitored prescription drug; or</text> </paragraph> <paragraph num="(b)"> <text>An individual for whom a pharmacist has dispensed or is considering dispensing a monitored prescription drug.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Pharmacist” means an individual who is licensed under Health-Occupations Article, Title 12, Annotated Code of Maryland, to dispense a monitored prescription drug.</text> </paragraph> <paragraph num="(17)"> <text>“Pharmacist delegate” means an individual who is:</text> <paragraph num="(a)"> <text>Authorized by a registered pharmacist to request or access prescription monitoring data; and</text> </paragraph> <paragraph num="(b)"> <text>Employed by or under contract with the same professional practice as the registered pharmacist.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Prescriber” means a practitioner:</text> <paragraph num="(a)"> <text>Lawfully authorized to prescribe a monitored prescription drug; or</text> </paragraph> <paragraph num="(b)"> <text>Legally authorized to prescribe a monitored prescription drug under an institutional DEA registration;</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Prescriber delegate” means an individual who is:</text> <paragraph num="(a)"> <text>Authorized by a registered prescriber to request or access prescription monitoring data; and</text> </paragraph> <paragraph num="(b)"> <text>Employed by or under contract with the same professional practice as the registered prescriber.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Prescription drug” has the meaning stated in Health-General Article, §21-201, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Prescription monitoring data” means the information submitted to the program for a monitored prescription drug.</text> </paragraph> <paragraph num="(22)"> <text>“Program” means the Prescription Drug Monitoring Program established under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(23)"> <text>“Registered” means a person registered with the Program to request or access prescription monitoring data for clinical use.</text> </paragraph> <paragraph num="(24)"> <text>“Rehabilitation program under a health occupations board” means a group, committee, or program recognized by a licensing entity that provides assistance to a licensed health care practitioner in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition.</text> </paragraph> <paragraph num="(25)"> <text>“Technical Advisory Committee” means the Technical Advisory Committee established by Health-General Article, §21-2A-07, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(26)"> <text>“Zero report” means an electronic report submitted by a dispenser to the Program to confirm that no monitored prescription drugs were dispensed during the reporting time frame.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Dispenser Reporting."> <paragraph num="A."> <text>For each monitored prescription drug and naloxone medication dispensed, the dispenser shall report data elements required by American Society for Automation in Pharmacy (ASAP) standards in addition to the following:</text> <paragraph num="(1)"> <text>Identifying information for the prescription issued and drug dispensed, including:</text> <paragraph num="(a)"> <text>Prescription number;</text> </paragraph> <paragraph num="(b)"> <text>Date prescription was issued;</text> </paragraph> <paragraph num="(c)"> <text>Date prescription was filled;</text> </paragraph> <paragraph num="(d)"> <text>Whether the prescription was new or a refill;</text> </paragraph> <paragraph num="(e)"> <text>Number of refills ordered;</text> </paragraph> <paragraph num="(f)"> <text>Sources of payment;</text> </paragraph> <paragraph num="(g)"> <text>National Drug Code for dispensed drug;</text> </paragraph> <paragraph num="(h)"> <text>Metric quantity of drug dispensed and units;</text> </paragraph> <paragraph num="(i)"> <text>Days’ supply of drug dispensed; and</text> </paragraph> <paragraph num="(j)"> <text>Date prescription was sold;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Identifying information for the patient or animal owner or handler, as appropriate, including:</text> <paragraph num="(a)"> <text>Last name;</text> </paragraph> <paragraph num="(b)"> <text>First name;</text> </paragraph> <paragraph num="(c)"> <text>Date of birth;</text> </paragraph> <paragraph num="(d)"> <text>Gender;</text> </paragraph> <paragraph num="(e)"> <text>(text unchanged)</text> </paragraph> <paragraph num="(f)"> <text>Address, including residential house or building number, apartment number, street name, state, and zip code;</text> </paragraph> <paragraph num="(g)"> <text>A patient identification number, which may include:</text> <paragraph num="(i)"> <text>A state-issued driver’s license or identification card number;</text> </paragraph> <paragraph num="(ii)"> <text>An insurance or third-party payer identification number;</text> </paragraph> <paragraph num="(iii)"> <text>A passport identification number;</text> </paragraph> <paragraph num="(iv)"> <text>An employer-issued identification card number;</text> </paragraph> <paragraph num="(v)"> <text>A student identification card number;</text> </paragraph> <paragraph num="(vi)"> <text>A United States Permanent Resident Card identification number; or</text> </paragraph> <paragraph num="(vii)"> <text>A patient or customer identification number generated by the dispenser’s record management system;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>ID qualifier; and</text> </paragraph> <paragraph num="(i)"> <text>Species indication;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>First and Last name for the prescriber, including:</text> <paragraph num="(a)"> <text>For prescription monitoring data, a valid Drug Enforcement Administration registration number; or</text> </paragraph> <paragraph num="(b)"> <text>For naloxone medication data, a valid National Provider Identifier;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Identifying information for the dispenser, including a valid Drug Enforcement Administration registration number; and</text> </paragraph> <paragraph num="(5)"> <text>Additional data elements consistent with the standards established by the ASAP.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Reporting Deadline.</text> <paragraph num="(1)"> <text>A dispenser shall report prescription monitoring data and naloxone medication data to the Department to include zero reports at least once every 24 hours and in accordance with procedures developed by the Department and approved by the Advisory Board on Prescription Drug Monitoring.</text> </paragraph> <paragraph num="(2)"> <text>A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report prescription monitoring data or naloxone medication data electronically shall:</text> <paragraph num="(a)"> <text>Notify the Department, by a communications method approved by the Department, within 24 hours of discovery of the technical failure; and</text> </paragraph> <paragraph num="(b)"> <text>Submit a report for each monitored prescription drug and naloxone medication dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Waiver from Reporting Deadline.</text> <paragraph num="(1)"> <text>At the Secretary’s discretion, a dispenser may be granted a waiver from §B of this regulation, provided that the dispenser’s waiver request:</text> <paragraph num="(a)"> <text>Is submitted on a form or in a method approved by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Is particular to a unique problem, incident or other issue that prevents the dispenser from meeting the reporting deadline; and</text> </paragraph> <paragraph num="(c)"> <text>Describes in detail and includes any available documentation of the specific circumstances that prevent the dispenser from meeting the reporting deadline.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A dispenser that receives a waiver shall comply with all the terms and conditions enumerated therein, including any new reporting deadline required.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Means of Data Submission and Data Format. Prescription monitoring data shall be transmitted to the Department or its agent:</text> <paragraph num="(1)"> <text>In accordance with any procedures and guidelines established or approved by the Department, including by use of an encrypted electronic transmission method or a secure electronic reporting form; and</text> </paragraph> <paragraph num="(2)"> <text>In a format or utilizing a data standard approved by the Department.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reporting of Incomplete or Inaccurate Data. Data not accepted by the Department or its agent due to inaccuracy or incompleteness shall be corrected and resubmitted to the Department no later than 3 business days after receiving notification from the Department of receipt of incomplete or inaccurate data.</text> </paragraph> <paragraph num="F."> <text>Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program:</text> <paragraph num="(1)"> <text>A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service program;</text> </paragraph> <paragraph num="(3)"> <text>A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;</text> </paragraph> <paragraph num="(4)"> <text>A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and</text> </paragraph> <paragraph num="(5)"> <text>Dispensing to hospice inpatients, provided that the dispensing pharmacy has applied for and been granted a waiver by the Department pursuant to §G of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Waiver for Dispensing to Hospice Inpatients.</text> <paragraph num="(1)"> <text>On a form or in a manner approved by the Department, a pharmacy may apply to the Department to be granted a waiver from reporting prescription monitoring data or naloxone medication data for dispensing of monitored prescription drugs to hospice inpatients, provided that:</text> <paragraph num="(a)"> <text>The pharmacy demonstrates, through written application, live demonstration, or any other method required by the Department, how it will distinguish dispensing to hospice inpatients from all other dispensing of monitored prescription drugs required to be reported to the Program; and</text> </paragraph> <paragraph num="(b)"> <text>The pharmacy agrees that it will be subject to unannounced, on-site inspections by the Department to verify its reporting of prescription monitoring data and naloxone medication data on customers that are not hospice inpatients.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A waiver granted to a pharmacy under this regulation shall remain in effect for 2 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Review of Prescription Monitoring Data."> <paragraph num="A."> <text>The Program shall review prescription monitoring data and naloxone medication data for indications of possible:</text> <paragraph num="(1)"> <text>Misuse or abuse of a monitored prescription drug; and</text> </paragraph> <paragraph num="(2)"> <text>Violations of law or possible breaches of professional standards by a prescriber or a dispenser.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether its review indicates a possible violation of law or possible breach of professional standards by a prescriber or dispenser, the Program shall take into account to the extent practicable the particular specialty, circumstances, patient type, and location of the prescriber or dispenser.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disclosure of Prescription Monitoring Data."> <paragraph num="A."> <text>Registration of a Prescriber, a Prescriber Delegate, a Pharmacist, a Pharmacist Delegate, or a Licensed Health Care Practitioner to Request Prescription Monitoring Data.</text> <paragraph num="(1)"> <text>A prescriber, a prescriber delegate, a pharmacist, a pharmacist delegate, or a licensed health care practitioner shall register with the Department or its agent, in a manner specified by the Department, in order to request disclosure of or otherwise access prescription monitoring data.</text> </paragraph> <paragraph num="(2)"> <text>The Department or its agent shall:</text> <paragraph num="(a)"> <text>Establish procedures to authenticate a prescriber, a dispenser, or an authorized licensed health care practitioner in accordance with Health-General Article, §21-2A-06(b)(1)—(2), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Issue credentials to a prescriber, a prescriber delegate, a pharmacist, or a pharmacist delegate that can be used to request disclosure of or otherwise access prescription monitoring data electronically.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the credentials issued to a registrant are lost, stolen, or otherwise compromised, the registrant shall notify the Department or its agent, by a method approved by the Department, as soon as reasonably possible.</text> </paragraph> <paragraph num="(4)"> <text>A prescriber or pharmacist who authorizes the registration of a licensed health care practitioner, prescriber delegate, or pharmacist delegate to request disclosure of or otherwise access prescription monitoring data shall:</text> <paragraph num="(a)"> <text>Make every reasonable effort, including regularly reviewing and auditing any available logs of system access and use, to ensure the prescriber delegate or pharmacist delegate is requesting disclosure of, redisclosing, or otherwise accessing prescription monitoring data in clear compliance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records;</text> </paragraph> <paragraph num="(b)"> <text>Immediately notify the Department or its agent, by a method approved by the Department, as well as the licensing entity responsible for licensing, certifying, or registering the prescriber delegate, or pharmacist delegate, if applicable, if the prescriber or pharmacist believes that the confidentiality of prescription monitoring data or the security of the Program has been compromised by that individual; and</text> </paragraph> <paragraph num="(c)"> <text>Immediately notify the Department or its agent, by a method approved by the Department, of any requested change in the registration status of a licensed health care practitioner, prescriber delegate, or pharmacist delegate, including if that individual is no longer employed by or practicing under the authority of the prescriber or pharmacist.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Disclosure of Prescription Monitoring Data to a Prescriber, a Prescriber Delegate, a Pharmacist, or a Pharmacist Delegate.</text> <paragraph num="(1)"> <text>Upon request from a prescriber or a licensed health care practitioner or a prescriber delegate authorized by a prescriber, the Program shall disclose patient-specific prescription monitoring data provided that the request is made solely for the purpose of the medical care or treatment of the patient about whom prescription monitoring data is being requested.</text> </paragraph> <paragraph num="(2)"> <text>Upon request from a prescriber, the Program may provide a report containing prescription monitoring data on all monitored prescription drugs dispensed pursuant to the prescriber’s prescriptions, provided that the request is submitted on a form or in a manner approved by the Department.</text> </paragraph> <paragraph num="(3)"> <text>Upon request from a pharmacist or a licensed health care practitioner or pharmacist delegate authorized by a pharmacist, the Program shall disclose patient-specific prescription monitoring data provided that the request is made pursuant to a pharmacist’s responsibility to perform due diligence and exercise professional judgment when presented with a prescription to dispense a monitored prescription drug for use by the patient about whom prescription monitoring data is being requested.</text> </paragraph> <paragraph num="(4)"> <text>The Department or its agent shall make available the electronic means by which a prescriber, a pharmacist, a prescriber delegate, or a pharmacist delegate may request disclosure of or otherwise access patient-specific prescription monitoring data.</text> </paragraph> <paragraph num="(5)"> <text>If the Program’s review of prescription monitoring data under Regulation .04 of this chapter indicates possible misuse or abuse of a monitored prescription drug, possible violation of law, or possible breach of professional standards by a prescriber or dispenser, the Program shall:</text> <paragraph num="(a)"> <text>Report the possible misuse or abuse, possible violation of law, or possible breach of professional standards to the prescriber or dispenser of the monitored prescription drug in a manner and form determined by the Program; and</text> </paragraph> <paragraph num="(b)"> <text>Provide education to the prescriber or dispenser.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Disclosure of Prescription Monitoring Data to a Federal, State, or Local Law Enforcement Agency. The Program shall disclose prescription monitoring data to a federal, State, or local law enforcement agency, for the purpose of furthering an existing bona fide individual investigation, on receipt of a subpoena that:</text> <paragraph num="(1)"> <text>Includes information sufficient to identify the unique prescriber, dispenser, or patient about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(2)"> <text>Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;</text> </paragraph> <paragraph num="(3)"> <text>Includes an agency case number or other identifier sufficient to identify an existing bona fide individual investigation; and</text> </paragraph> <paragraph num="(4)"> <text>Bears the name, title, and signature of the official under whose authority the subpoena is issued.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Disclosure of Prescription Monitoring Data to a Licensing Entity.</text> <paragraph num="(1)"> <text>The Program shall disclose prescription monitoring data to a licensing entity upon receipt of an administrative subpoena.</text> </paragraph> <paragraph num="(2)"> <text>The licensing entity shall include in the administrative subpoena:</text> <paragraph num="(a)"> <text>Information sufficient to identify the unique prescriber, dispenser, or patient about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(b)"> <text>The time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;</text> </paragraph> <paragraph num="(c)"> <text>A case number or other identifier sufficient to identify an existing bona fide individual investigation; and</text> </paragraph> <paragraph num="(d)"> <text>The name, title, and original signature of the official under whose authority the subpoena is issued.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Disclosure of Prescription Monitoring Data to a Rehabilitation Program under a Health Occupations Board. The Program shall disclose prescription monitoring data to a rehabilitation program under a health occupations board upon receipt of an administrative subpoena that:</text> <paragraph num="(1)"> <text>Includes information sufficient to identify the unique licensed health care practitioner about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(2)"> <text>Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; and</text> </paragraph> <paragraph num="(3)"> <text>Bears the name, title and original signature of the official under whose authority the subpoena is issued.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disclosure of Prescription Monitoring Data to a Patient or a Patient’s Authorized Representative.</text> <paragraph num="(1)"> <text>Upon request, the Program shall disclose to a patient 18 years old or older prescription monitoring data about the patient provided that the request is submitted to the Program:</text> <paragraph num="(a)"> <text>On a completed form approved by the Department that contains a notarized signature of the requester; or</text> </paragraph> <paragraph num="(b)"> <text>In any other manner approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon request, the Program shall disclose patient-specific prescription monitoring data to a patient’s authorized representative who is 18 years old or older, including the parent or legal guardian of a minor, an individual with power of attorney, the personal representative of a decedent’s estate, or any other person duly authorized by State law to request or otherwise access medical records on behalf of a patient, provided that the request shall be submitted to the Program:</text> <paragraph num="(a)"> <text>In person and accompanied by:</text> <paragraph num="(i)"> <text>A completed form approved by the Department;</text> </paragraph> <paragraph num="(ii)"> <text>Valid photo identification issued by a government agency of any jurisdiction of the United States verifying that the patient’s authorized representative is 18 years old or older; and</text> </paragraph> <paragraph num="(iii)"> <text>An original copy of any form or documentation required by State law or regulation to verify the authority of the representative to request or otherwise access the medical records of a patient on their behalf; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In any other manner approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a patient, a patient’s authorized representative, or a patient’s prescriber believes that prescription monitoring data relating to the patient’s prescription history is incorrect, the patient, authorized representative, or prescriber may request that the Program correct the data provided that the request:</text> <paragraph num="(a)"> <text>Is submitted to the Program in writing and on a form or in a manner approved by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Includes documentation, which may include but not be limited to, a copy of the original prescription and a signed, notarized statement from the prescriber or dispenser that demonstrates which of the specific data elements reported to the Program under Regulation .03A of this chapter are incorrect.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon determination by the Secretary that prescription monitoring data specific to a patient’s prescription history is incorrect, the Program shall issue a corrected prescription history report to the patient or the patient’s authorized representative.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Disclosure of Prescription Monitoring Data to the Office of the Attorney General. The Program shall disclose prescription monitoring data to the Office of the Attorney General, for the purpose of furthering an existing bona fide investigation, on receipt of a subpoena that:</text> <paragraph num="(1)"> <text>Includes information sufficient to identify the prescribers, dispensers, or patients about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(2)"> <text>Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;</text> </paragraph> <paragraph num="(3)"> <text>Includes an agency case number or other identifier sufficient to identify an existing bona fide investigation; and</text> </paragraph> <paragraph num="(4)"> <text>Bears the name, title, and signature of the official under whose authority the subpoena is issued.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Disclosure of Prescription Monitoring Data to an Authorized User of Another State’s Prescription Drug Monitoring Program or of any Other Authorized Agency.</text> <paragraph num="(1)"> <text>Upon request, the Program shall disclose prescription monitoring data to an authorized user of another state’s prescription drug monitoring program or an authorized user with any other authorized local, state, territorial, or federal agency in connection with the provision of medical care, provided that the request:</text> <paragraph num="(a)"> <text>Is submitted in a manner approved by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Is under the authority of the authorized administrator of that state’s program or authorized agency;</text> </paragraph> <paragraph num="(c)"> <text>Includes an attestation that prescription monitoring data will only be used or redisclosed in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .08D of this chapter; and</text> </paragraph> <paragraph num="(d)"> <text>Relates to a patient to whom the authorized user anticipates providing, is providing, or has provided medical care.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Program may develop and implement interoperability with another state’s prescription drug monitoring program or authorized agency to facilitate the automated exchange of prescription monitoring data provided that a written agreement has been established with the other state’s program or authorized agency specifying that the information technology employed will:</text> <paragraph num="(a)"> <text>Only disclose prescription monitoring data to authorized users in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Operate in accordance with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Disclosure of Prescription Monitoring Data to Units of the Department. Upon request, the Program may disclose prescription monitoring data to the Maryland Medical Assistance Program, the Office of the Inspector General of the Department, the Office of Health Care Quality, and the Office, provided that the request:</text> <paragraph num="(1)"> <text>Includes information sufficient to identify the unique individual about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(2)"> <text>Specifies the time frame for which prescription monitoring data is requested, including the day, month and year the report is to begin and end;</text> </paragraph> <paragraph num="(3)"> <text>Includes a case number or other identifier sufficient to identify an existing bona fide individual investigation; and</text> </paragraph> <paragraph num="(4)"> <text>Is approved by the Secretary.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Disclosure of Prescription Monitoring Data to a Medical Director of a Health Care Facility. The Program may disclose prescription monitoring data to the medical director of a health care facility, as defined in Health-General Article, §19-114, Annotated Code of Maryland, or the medical director’s designee for the purpose of providing health care practitioners employed or contractually employed at the health care facility access to the prescription monitoring data in connection with the provision of medical care or the dispensing of a monitored prescription drug to an individual who receives health care at the health care facility and on whom a medical record is maintained at the health care facility, provided that the health care facility:</text> <paragraph num="(1)"> <text>Is licensed by the Department of Health or is operated by the federal government or a federally recognized Indian tribe;</text> </paragraph> <paragraph num="(2)"> <text>Has an active participation agreement with the State’s Health Information Exchange;</text> </paragraph> <paragraph num="(3)"> <text>Operates in accordance with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; and</text> </paragraph> <paragraph num="(4)"> <text>Can provide an audit trail of the facility’s staff access to the prescription monitoring data to the Department upon request.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Disclosure of Prescription Monitoring Data to the Office of the Chief Medical Examiner.</text> <paragraph num="(1)"> <text>Upon request from the Office of Chief Medical Examiner, the Program shall disclose decedent-specific prescription monitoring data, provided that the request is made solely for the purpose of carrying out duties authorized under Health-General Article, §5-309, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall determine the electronic means by which the Office of the Chief Medical Examiner may request disclosure of or otherwise access decedent-specific prescription monitoring data.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Disclosure of Prescription Monitoring Data to Case Review Entities.</text> <paragraph num="(1)"> <text>Upon request, the Program may disclose prescription monitoring data to the following case review entities for the purposes of furthering an existing bona fide individual case review:</text> <paragraph num="(a)"> <text>The State Child Fatality Review Team or a local child fatality review team as defined in Health-General Article, §5-701, Annotated Code of Maryland, upon request from the chair of the State or local team;</text> </paragraph> <paragraph num="(b)"> <text>A local drug overdose fatality review team as described in Health-General Article, §5-902, Annotated Code of Maryland, upon request from the chair of the local team;</text> </paragraph> <paragraph num="(c)"> <text>The Maternal Mortality Review Program, as defined in Health-General Article, §13-1203, Annotated Code of Maryland, on request from the Program; and</text> </paragraph> <paragraph num="(d)"> <text>A medical review committee described in Health Occupations Article, §1-401(b)(3), Annotated Code of Maryland, upon request from the committee.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The request shall:</text> <paragraph num="(a)"> <text>Include information sufficient to identify the unique individual about whom prescription monitoring data is requested;</text> </paragraph> <paragraph num="(b)"> <text>Specify the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;</text> </paragraph> <paragraph num="(c)"> <text>Include a case number or other identifier sufficient to identify an existing bona fide individual case review; and</text> </paragraph> <paragraph num="(d)"> <text>Be approved by the Secretary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="M."> <text>Disclosure of Prescription Monitoring Data for Research, Analysis, Education, and Public Reporting.</text> <paragraph num="(1)"> <text>The Program may disclose prescription monitoring data for research, analysis, education, and public reporting:</text> <paragraph num="(a)"> <text>In response to requests determined by the Department to be consistent with institutional review board protocols and human subjects research protections;</text> </paragraph> <paragraph num="(b)"> <text>Upon approval by the Department of a written proposal or abstract explaining the purpose and scope of the research, analysis, education, and public reporting; and</text> </paragraph> <paragraph num="(c)"> <text>After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Secretary may waive the requirement of §M(1)(b) of this regulation for requests from units of the Department.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Technical Advisory Committee Review.</text> <paragraph num="(1)"> <text>Before the Program discloses prescription monitoring data under §§C—E, H, and I of this regulation, the Technical Advisory Committee may:</text> <paragraph num="(a)"> <text>Review the request for disclosure; and</text> </paragraph> <paragraph num="(b)"> <text>Within 10 business days of submission of the request to the Technical Advisory Committee for review, submit to the Program, in written form, clinical guidance and interpretation of the prescription monitoring data requested to:</text> <paragraph num="(i)"> <text>Assist the Secretary’s decision on how to respond to a judicial subpoena, administrative subpoena, or other request; and</text> </paragraph> <paragraph num="(ii)"> <text>Be made available for use by the recipient of prescription monitoring data should the request for disclosure be authorized.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notwithstanding §N(1) of this regulation, the Program may disclose prescription monitoring data to the authorized administrator of another state’s prescription drug monitoring program or authorized agency for disclosure to an authorized user in a manner consistent with §H of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Before the Program discloses prescription monitoring data to a prescriber or dispenser under §B(5) of this regulation, the Technical Advisory Committee:</text> <paragraph num="(a)"> <text>For indications of possible misuse or abuse, may provide clinical guidance and interpretation of the prescription monitoring data that indicates possible misuse or abuse; and</text> </paragraph> <paragraph num="(b)"> <text>For indications of possible violations of law or breach of professional standards, shall provide clinical guidance regarding the method used and advise whether the method identifies possible violations of law or breach of professional standards.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the Technical Advisory Committee has not provided clinical guidance and interpretation in accordance with §N(1) or (3) of this regulation within 10 business days of submission of the request or data to the Technical Advisory Committee for review, the Program may proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide regarding the request, data, or method at issue.</text> </paragraph> <paragraph num="(5)"> <text>Before making a referral to the Office in accordance with Regulation .05O of this chapter, the Program shall provide to the Technical Advisory Committee notice and an opportunity to make recommendations within 10 business days on the referral.</text> </paragraph> <paragraph num="(6)"> <text>If the Technical Advisory Committee has not provided recommendations within 10 business days under §N(5) of this regulation, the Program may proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide.</text> </paragraph> <paragraph num="(7)"> <text>The Department shall establish procedures, which may include but not be limited to secure electronic messaging, for the timely disclosure of prescription monitoring data to the Technical Advisory Committee and the receipt of responses from the Technical Advisory Committee to ensure that the review process is conducted with all possible expediency.</text> </paragraph> <paragraph num="(8)"> <text>For all purposes, including but not limited to confidentiality, security, redisclosure, and admissibility as evidence, Program reports based on evaluation of prescription monitoring data and that contain individual identifying information shall be considered as one and the same with the prescription monitoring data.</text> </paragraph> </paragraph> <paragraph num="O."> <text>Disclosure of Prescription Monitoring Data to the Office. The Program may disclose prescription monitoring data and make a referral to the Office about a possible violation of law or possible breach of professional standards by a prescriber or dispenser as identified under Regulation .04 of this chapter, if the Program:</text> <paragraph num="(1)"> <text>Determines the:</text> <paragraph num="(a)"> <text>Outreach and education provided was inadequate to address the possible breach or violation; or</text> </paragraph> <paragraph num="(b)"> <text>Outreach and education would be inadequate to address the possible violations of law or a possible breach of professional standards;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provides notice and an opportunity to the Technical Advisory Committee to make recommendations within 10 business days regarding interpretation of the prescription monitoring data;</text> </paragraph> <paragraph num="(3)"> <text>Provides the recommendations, if any, of the Technical Advisory Committee to the Office; and</text> </paragraph> <paragraph num="(4)"> <text>Notifies the prescriber or the dispenser that the prescription monitoring data will be provided to the Office for further investigation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Disclosure of Naloxone Medication Data."> <text>Disclosure of Naloxone Medication Data for Public Health Surveillance, Research, Analysis, Education, and Public Reporting.</text> <paragraph num="A."> <text>The Program shall disclose naloxone medication data for research, analysis, education, and public reporting:</text> <paragraph num="(1)"> <text>Upon approval by the Department of a written proposal or abstract explaining the purpose and scope of the research, analysis, education, and public reporting; and</text> </paragraph> <paragraph num="(2)"> <text>After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Secretary may waive the requirement of §A(1) of this regulation for requests from units of the Department.</text> </paragraph> <paragraph num="C."> <text>The Program may disclose de-identified naloxone medication data for public health surveillance purposes.</text> </paragraph> <paragraph num="D."> <text>The Program may not disclose identifiable naloxone medication data to any entity, including but not limited to prescribers or dispensers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Notice to Patients."> <paragraph num="A."> <text>Pharmacists.</text> <paragraph num="(1)"> <text>Any pharmacist who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public at the place where the prescription is delivered to the pharmacist.</text> </paragraph> <paragraph num="(2)"> <text>The sign shall disclose to the public that the pharmacist may access prescription monitoring data on a patient for whom a prescription for a monitored prescription drug is presented.</text> </paragraph> <paragraph num="(3)"> <text>In lieu of posting a sign, the pharmacist may provide such notice in written material provided to the patient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prescriber.</text> <paragraph num="(1)"> <text>Any prescriber who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public that discloses to the public that the prescriber may access prescription monitoring data on a patient.</text> </paragraph> <paragraph num="(2)"> <text>In lieu of posting a sign, the prescriber may provide such notice in written material provided to the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality."> <paragraph num="A."> <text>Prescription monitoring data and naloxone medication data are confidential, privileged, not subject to discovery, subpoena, or other means of legal compulsion in civil litigation, and are not public records.</text> </paragraph> <paragraph num="B."> <text>The Program shall ensure that confidential or privileged patient information be kept confidential and that records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter, does not disclose the identity of the person protected.</text> </paragraph> <paragraph num="C."> <text>The Program shall periodically conduct an audit review of prescription monitoring data and naloxone medication data and disclosure requests to ensure compliance with §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Penalties and Sanctions."> <paragraph num="A."> <text>Civil Penalties. A dispenser who knowingly fails to submit prescription monitoring data or naloxone medication data to the Program as required by Regulation .03 of this chapter shall be subject to a civil penalty not exceeding $500 for each failure to submit required information.</text> </paragraph> <paragraph num="B."> <text>Criminal Penalties. A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit prescription monitoring data or naloxone medication data in violation of in Health-General Article, §21-2A, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both.</text> </paragraph> <paragraph num="C."> <text>Administrative Sanctions. A prescriber or pharmacist who knowingly discloses or uses prescription monitoring data or naloxone medication data in violation of Health-General Article, §21-2A, Annotated Code of Maryland shall be subject to disciplinary action by the appropriate licensing entity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="General Provisions."> <paragraph num="A."> <text>The Program shall make available the information technology necessary for dispensers to report prescription monitoring data and naloxone medication data to the Program.</text> </paragraph> <paragraph num="B."> <text>The Program may not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program.</text> </paragraph> <paragraph num="C."> <text>A prescriber or pharmacist, when acting in good faith, is not subject to liability or disciplinary action arising solely from:</text> <paragraph num="(1)"> <text>Requesting or receiving prescription monitoring data from the Program; or</text> </paragraph> <paragraph num="(2)"> <text>Acting, or failing to act, on the basis of prescription monitoring data provided by the Program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Redisclosure of Prescription Monitoring Data.</text> <paragraph num="(1)"> <text>Prescription monitoring data received under Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .05 of this chapter may be redisclosed only:</text> <paragraph num="(a)"> <text>In a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §1320d et seq., as amended, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; or</text> </paragraph> <paragraph num="(b)"> <text>For entities to which the Program has disclosed data, in furtherance of an existing, bona fide, individual investigation to another agency cooperating with or providing support to the original data.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The release of prescription monitoring data by a prescriber or pharmacist to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Redisclosure of Naloxone Medication Data. Naloxone medication data received under Health-General Article, §21-2A-6.1, Annotated Code of Maryland, and Regulation .05-1 of this chapter may be redisclosed only in a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §1320d et seq., as amended, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records.</text> </paragraph> <paragraph num="F."> <text>The Program shall retain prescription monitoring data and naloxone medication data for 5 years from the date of receipt.</text> </paragraph> <paragraph num="G."> <text>A member of the Technical Advisory Committee:</text> <paragraph num="(1)"> <text>Shall serve for a term of 3 years from the date of appointment; and</text> </paragraph> <paragraph num="(2)"> <text>May be reappointed at the discretion of the Secretary.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 7, 2013 (39:26 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04H amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 8, 2015 (42:11 Md. R.725)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 8, 2018 (45:20 Md. R. 918); May 18, 2020 (47:10 Md. R. 519); July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, F amended effective October 8, 2018 (45:20 Md. R. 918)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 29, 2016 (43:4 Md. R. 332); October 8, 2018 (45:20 Md. R. 918); May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D, F amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective October 8, 2018 (45:20 Md. R. 918)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, C amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective October 8, 2018 (45:20 Md. R. 918)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective July 20, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C—E amended effective October 8, 2018 (45:20 Md. R. 918)</annotation> </annotations> </chapter> <chapter num="08" heading="Overdose Response Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the requirements for the Overdose Response Program administered by the Department for the purpose of providing a means of training individuals to administer naloxone to an individual experiencing, or believed to be experiencing, opioid overdose to help prevent a fatality when medical services are not immediately available.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(2)"> <text>“Education and training program” means educational instruction in opioid overdose recognition and response and the administration of naloxone.</text> </paragraph> <paragraph num="(3)"> <text>“Emergency medical services” means the Statewide comprehensive system of emergency medical care.</text> </paragraph> <paragraph num="(4)"> <text>“Health care provider” means an individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, or Education Article, §13-516, Annotated Code of Maryland, to provide health care services;</text> </paragraph> <paragraph num="(5)"> <text>“Naloxone” means an opioid antagonist medication used to counter the effects of an opioid overdose.</text> </paragraph> <paragraph num="(6)"> <text>“Pharmacist” means an individual licensed to practice pharmacy in Maryland under Health Occupations Article, Title 12, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Private or Public Entity” means a health care provider, local health department, community-based organization, substance use disorder treatment organization, or other person that addresses medical or social issues related to drug addiction.</text> </paragraph> <paragraph num="(8)"> <text>“Standing order” means a written instruction for the prescribing and dispensing of naloxone in accordance with Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Authorization of a Private or Public Entity."> <paragraph num="A."> <text>Application for Authorization. A private or public entity that seeks to conduct education and training programs under Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland, shall submit to the Department:</text> <paragraph num="(1)"> <text>A completed application form containing all identifying information for the private or public entity that is required by the Department, including:</text> <paragraph num="(a)"> <text>Entity name;</text> </paragraph> <paragraph num="(b)"> <text>Type of entity based on categories supplied by the Department;</text> </paragraph> <paragraph num="(c)"> <text>Entity address;</text> </paragraph> <paragraph num="(d)"> <text>Entity telephone number;</text> </paragraph> <paragraph num="(e)"> <text>Entity email address;</text> </paragraph> <paragraph num="(f)"> <text>Name of Entity Director;</text> </paragraph> <paragraph num="(g)"> <text>Name of Training Program Director; and</text> </paragraph> <paragraph num="(h)"> <text>Any additional information as requested by the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a public or private entity intending to provide naloxone:</text> <paragraph num="(a)"> <text>A copy of a written agreement between a health care provider with prescribing authority and the private or public entity for the prescribing and dispensing of naloxone;</text> </paragraph> <paragraph num="(b)"> <text>Identifying information for the health care provider with prescribing authority including:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Title;</text> </paragraph> <paragraph num="(iii)"> <text>Address;</text> </paragraph> <paragraph num="(iv)"> <text>Phone number;</text> </paragraph> <paragraph num="(v)"> <text>Email address; and</text> </paragraph> <paragraph num="(vi)"> <text>State license number; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If applicable, a copy of the entity’s dispensing protocols for naloxone;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A description of ancillary topics to be covered in addition to the core educational training curriculum provided by the Department pursuant to Regulation .04A(2) of this chapter, and copies of any training materials to be used during instruction;</text> </paragraph> <paragraph num="(4)"> <text>Any other information required by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Any fee required by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Approval of Applications. Upon approval of an application for authorization, the Department shall issue to the private or public entity a form that includes:</text> <paragraph num="(1)"> <text>The name of the private or public entity and its director;</text> </paragraph> <paragraph num="(2)"> <text>A statement that the private or public entity is authorized by the Department to conduct education and training programs;</text> </paragraph> <paragraph num="(3)"> <text>A serial number;</text> </paragraph> <paragraph num="(4)"> <text>The date of the approval of the authorization; and</text> </paragraph> <paragraph num="(5)"> <text>The date of the expiration of the authorization.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Term of Authorization. An authorization under this chapter shall be valid for 2 years.</text> </paragraph> <paragraph num="D."> <text>Notification of Significant Change of Information. An authorized private or public entity shall notify the Department in writing of any significant change in the information that was submitted in the application for authorization under §A(1)—(5) of this chapter within 30 days of such change.</text> </paragraph> <paragraph num="E."> <text>Authorization Renewal.</text> <paragraph num="(1)"> <text>An authorized private or public entity may apply to the Department for renewal of its authorization to conduct education and training programs.</text> </paragraph> <paragraph num="(2)"> <text>An authorized private or public entity shall submit to the Department a completed renewal application form, along with any fee required by the Department, on a schedule set by the Department.</text> </paragraph> <paragraph num="(3)"> <text>The Department may request additional information from the private or public entity as necessary to render a decision on the renewal application.</text> </paragraph> <paragraph num="(4)"> <text>If the Department finds, after review of the application for authorization renewal, that the private or public entity is in compliance with the requirements for initial authorization set forth in this chapter, the Department shall issue a renewal authorization form to the private or public entity that includes the information set forth in §B of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>An authorization renewal under this chapter shall be valid for 2 years.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Expiration without Renewal. The Department may require a private or public entity whose authorization has expired without renewal to reapply for initial authorization as required under §A of this regulation.</text> </paragraph> <paragraph num="G."> <text>Maintenance of Records. The Department shall maintain a record of each authorized private or public entity, including all information submitted by the private or public entity in the initial application for authorization and any additional information provided in an application for authorization renewal.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Education and Training Programs."> <paragraph num="A."> <text>A private or public entity authorized by the Department:</text> <paragraph num="(1)"> <text>Shall offer an education and training program on opioid overdose recognition and response; and</text> </paragraph> <paragraph num="(2)"> <text>May provide access to naloxone.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Education and training shall include a core curriculum provided by the Department. The core curriculum shall include:</text> <paragraph num="(1)"> <text>Education on recognizing the symptoms and signs of an opioid overdose;</text> </paragraph> <paragraph num="(2)"> <text>Training on responding to an opioid overdose;</text> </paragraph> <paragraph num="(3)"> <text>The proper use and administration of naloxone;</text> </paragraph> <paragraph num="(4)"> <text>Proper rescue breathing technique;</text> </paragraph> <paragraph num="(5)"> <text>The importance of contacting emergency medical services;</text> </paragraph> <paragraph num="(6)"> <text>The care of an individual after the administration of naloxone; and</text> </paragraph> <paragraph num="(7)"> <text>Any other topic required by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may approve multiple core curricula:</text> <paragraph num="(1)"> <text>For use in training specific populations;</text> </paragraph> <paragraph num="(2)"> <text>For delivery in specific settings; or</text> </paragraph> <paragraph num="(3)"> <text>Based on other relevant factors.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Education and training may include any other relevant topic at the discretion of the authorized private or public entity conducting the education and training.</text> </paragraph> <paragraph num="E."> <text>A private or public entity authorized by the Department under this chapter may offer a training program online.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Naloxone Use."> <paragraph num="A."> <text>An individual of any age may receive from any health care provider with prescribing authority a prescription for naloxone and the necessary supplies for the administration of naloxone.</text> </paragraph> <paragraph num="B."> <text>An individual for whom naloxone is prescribed and dispensed in accordance with this chapter may:</text> <paragraph num="(1)"> <text>Possess prescribed naloxone and the necessary supplies for the administration of naloxone; and</text> </paragraph> <paragraph num="(2)"> <text>In an emergency situation when medical services are not immediately available, administer naloxone to an individual experiencing or believed by the individual to be experiencing an opioid overdose.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual who, in accordance with Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland, and this regulation, is administering naloxone to an individual experiencing, or believed by the individual to be experiencing an opioid overdose, may not be considered to be practicing:</text> <paragraph num="(1)"> <text>Medicine for the purposes of Health Occupations Article, Title 14, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Registered nursing for the purposes of Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual may report information on the administration of naloxone by the individual, overdose reversals, and other program outcomes to:</text> <paragraph num="(1)"> <text>The private and public entity that provided training;</text> </paragraph> <paragraph num="(2)"> <text>The Maryland Poison Center;</text> </paragraph> <paragraph num="(3)"> <text>The Department; or</text> </paragraph> <paragraph num="(4)"> <text>Any other entity identified by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Naloxone Prescribing and Dispensing."> <paragraph num="A."> <text>A healthcare provider with prescribing authority may prescribe and dispense naloxone to an individual of any age who:</text> <paragraph num="(1)"> <text>Is believed by the health care provider to be at risk of experiencing an opioid overdose; or</text> </paragraph> <paragraph num="(2)"> <text>Is in a position to assist an individual at risk of experiencing an opioid overdose.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A health care provider with prescribing authority may prescribe and dispense naloxone by issuing a standing order if the health care provider:</text> <paragraph num="(1)"> <text>Is employed by the department or a local health department; or</text> </paragraph> <paragraph num="(2)"> <text>Has a written agreement with an authorized private or public entity under Health-General Article, §13-3104, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A health care provider with prescribing authority who issues a standing order may delegate the dispensing of naloxone to an employee or a volunteer of an authorized private or public entity in accordance with a written agreement under Health-General Article, §13-3104, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>A health care provider who has dispensing authority also may dispense naloxone to any individual of any age in accordance with a standing order issued by a health care provider in accordance with Health-General Article, §13-3106, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Denial, Suspension, and Revocation of Authorization of a Private or Public Entity."> <paragraph num="A."> <text>If the Department determines that a private or public entity has failed to comply with the requirements of this chapter, the Department may initiate one or more of the following actions against the private or public entity:</text> <paragraph num="(1)"> <text>Denial of an initial application for authorization;</text> </paragraph> <paragraph num="(2)"> <text>Denial of an application for authorization renewal;</text> </paragraph> <paragraph num="(3)"> <text>Suspension of the authorization of the private or public entity; or</text> </paragraph> <paragraph num="(4)"> <text>Revocation of authorization of the private or public entity.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notification to Applicant or Private or Public Entity.</text> <paragraph num="(1)"> <text>The Department shall notify an applicant or private or public entity in writing of the denial of initial application for authorization, denial of application for authorization renewal, suspension of authorization, or revocation of authorization.</text> </paragraph> <paragraph num="(2)"> <text>The written notice shall include:</text> <paragraph num="(a)"> <text>The reason for the action taken;</text> </paragraph> <paragraph num="(b)"> <text>The effective date of the action;</text> </paragraph> <paragraph num="(c)"> <text>The procedure for appeal of the decision to deny an initial application for, or to suspend, revoke, or not renew the authorization of, a private or public entity; and</text> </paragraph> <paragraph num="(d)"> <text>Notification that the private or public entity may file an appeal of the Department’s decision and that any such appeal shall be filed within 10 days of receipt of the notice.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Summary Suspension.</text> <paragraph num="(1)"> <text>Under State Government Article, §10-226(c), Annotated Code of Maryland, the Department may summarily suspend the authorization of a private or public entity if the Department finds that the public health, safety, or welfare imperatively requires emergency action.</text> </paragraph> <paragraph num="(2)"> <text>From the time of receipt of the notice of summary suspension, the private or public entity may not:</text> <paragraph num="(a)"> <text>Conduct an education and training program; or</text> </paragraph> <paragraph num="(b)"> <text>Provide access to naloxone.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement of Authorization after Suspension. The Department may lift the suspension and reinstate authorization of a private or public entity if:</text> <paragraph num="(1)"> <text>The private or public entity submits in writing to the Department a request for the reinstatement that documents how the conditions leading to the suspension have been remedied or corrected; and</text> </paragraph> <paragraph num="(2)"> <text>The Department verifies that the conditions leading to the suspension have been remedied or corrected.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Application after Revocation. After authorization of a private or public entity has been revoked for a period of 12 months, the former authorized entity may reapply for authorization approval pursuant to the process set forth in Regulation .03 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeals."> <text>A private or public entity may request a hearing on an action taken by the Department pursuant to Regulation .07 of this chapter as allowed by:</text> <paragraph num="A."> <text>COMAR 10.01.03;</text> </paragraph> <paragraph num="B."> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>Health-General Article, Title 2, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Record Maintenance and Reporting."> <paragraph num="A."> <text>The Department shall maintain the following records:</text> <paragraph num="(1)"> <text>Information on private or public entities authorized by the Department, including:</text> <paragraph num="(a)"> <text>Names of entities and directors;</text> </paragraph> <paragraph num="(b)"> <text>Addresses of entities;</text> </paragraph> <paragraph num="(c)"> <text>Serial numbers of the initial authorizations;</text> </paragraph> <paragraph num="(d)"> <text>Initial authorization dates; and</text> </paragraph> <paragraph num="(e)"> <text>Dates of authorization renewals; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Information on private or public entities whose authorization has been suspended or revoked, including:</text> <paragraph num="(a)"> <text>Names of entities and directors;</text> </paragraph> <paragraph num="(b)"> <text>Addresses of entities;</text> </paragraph> <paragraph num="(c)"> <text>Serial numbers of the initial authorizations;</text> </paragraph> <paragraph num="(d)"> <text>Effective dates of suspensions or revocations;</text> </paragraph> <paragraph num="(e)"> <text>Reasons for suspensions or revocations; and</text> </paragraph> <paragraph num="(f)"> <text>If applicable, dates on which the approvals for authorization were reinstated.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If providing naloxone, a private or public entity authorized by the Department shall maintain records for each individual who has been provided naloxone, including:</text> <paragraph num="(1)"> <text>Full name of individual;</text> </paragraph> <paragraph num="(2)"> <text>Name of prescriber;</text> </paragraph> <paragraph num="(3)"> <text>Name and address of dispenser;</text> </paragraph> <paragraph num="(4)"> <text>Date of dispensing; and</text> </paragraph> <paragraph num="(5)"> <text>Type and dosage of naloxone dispensed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Reporting Information to the Department. A private or public entity authorized by the Department shall report to the Department:</text> <paragraph num="(1)"> <text>Information on program operations, including:</text> <paragraph num="(a)"> <text>Number of individuals who have completed education and training programs;</text> </paragraph> <paragraph num="(b)"> <text>For private or public entities authorized by the Department that provide naloxone directly or by means of a voucher for redemption at a pharmacy:</text> <paragraph num="(i)"> <text>Form of naloxone dispensed;</text> </paragraph> <paragraph num="(ii)"> <text>Number of initial doses of naloxone dispensed; and</text> </paragraph> <paragraph num="(iii)"> <text>Number of naloxone refills dispensed; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Number and location of naloxone administrations and overdose reversals to the extent this information is reported to the private or public entity authorized by the Department;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Demographic information on individuals who participated in an education and training program, including aggregate number of individuals by:</text> <paragraph num="(a)"> <text>Sex;</text> </paragraph> <paragraph num="(b)"> <text>Ethnicity;</text> </paragraph> <paragraph num="(c)"> <text>Race;</text> </paragraph> <paragraph num="(d)"> <text>Age; and</text> </paragraph> <paragraph num="(e)"> <text>The specific reason to receive education and training; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Any other information required by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Information under §C of this regulation shall be reported by the private or public entity authorized by the Department on a monthly basis in a format specified by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="General Provisions."> <paragraph num="A."> <text>Waiver of Fees. The Department may waive any fee required under this chapter.</text> </paragraph> <paragraph num="B."> <text>Discipline of a Health Care Provider. A health care provider who prescribes or dispenses naloxone to an individual in good faith, may not be subject to any disciplinary action under Health Occupations Article, Annotated Code of Maryland, solely for the act of prescribing or dispensing naloxone to the individual.</text> </paragraph> <paragraph num="C."> <text>A cause of action may not arise against any health care provider with prescribing authority, or pharmacist for any act or omission when prescribing or dispensing naloxone and the necessary paraphernalia for the administration of naloxone to an individual in good faith under Health General Article, §13-3108, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>An individual who administers naloxone to an individual who is or in good faith is believed to be experiencing an opioid overdose shall have immunity from liability under Courts and Judicial Proceedings Article, §§5–603 and 5–629, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 3, 2014 (41:4 Md. R. 301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, D amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B, C amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D adopted effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 12, 2016 (43:18 Md. R. 1017)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 7, 2019 (46:20 Md. R. 845)</annotation> </annotations> </chapter> </subtitle> <subtitle num="48" heading="Child Abuse and Neglect Medical Reimbursement Program"> <chapter num="01" heading="Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Defines the emergency medical treatment and the limitations on this treatment paid for by the Department for the victims of child abuse and neglect;</text> </paragraph> <paragraph num="B."> <text>Defines provider license requirements and conditions for participation, payment, and reimbursement provisions; and</text> </paragraph> <paragraph num="C."> <text>Establishes appeal procedures.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abuse” means:</text> <paragraph num="(a)"> <text>The physical or mental injury of a child by any parent or other person who has permanent or temporary care or custody or responsibility for supervision of a child, or by any household or family member, under circumstances that indicate that the child's health or welfare is harmed or at substantial risk of being harmed; or</text> </paragraph> <paragraph num="(b)"> <text>Sexual abuse of a child, whether physical injuries are sustained or not.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Child” means any individual under 18 years old.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency medical treatment” means medical or surgical care rendered by a physician or health care institution to a child to relieve any urgent illness or life threatening health condition or to determine the nature or extent of any alleged injury or health condition. Emergency medical treatment does not include non-emergency outpatient treatment or periodic nonemergency health care.</text> </paragraph> <paragraph num="(5)"> <text>“Examination” means the medical evaluation of a child to determine the nature and extent of any physical neglect, physical injury, or physical abuse.</text> </paragraph> <paragraph num="(6)"> <text>“Local department of social services” means the Baltimore City or county social services department under the supervision of the Social Services Administration.</text> </paragraph> <paragraph num="(7)"> <text>“Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text> </paragraph> <paragraph num="(8)"> <text>“Mental injury” means the observable, identifiable, and substantial impairment of a child's mental or psychological ability to function.</text> </paragraph> <paragraph num="(9)"> <text>“Neglect” means the leaving of a child unattended or other failure to give proper care and attention to a child by any parent or other person who has permanent or temporary care or custody or responsibility for supervision of the child, under circumstances that indicate:</text> <paragraph num="(a)"> <text>That the child's health or welfare is harmed or placed at substantial risk of harm; or</text> </paragraph> <paragraph num="(b)"> <text>Mental injury to the child or a substantial risk of mental injury.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Physician” means an individual legally licensed to practice medicine in Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Program” means the Child Abuse and Neglect Medical Reimbursement Program.</text> </paragraph> <paragraph num="(12)"> <text>“Provider” means any physician or health care institution which renders medical care or services to a child who has been or is alleged to have been abused or neglected.</text> </paragraph> <paragraph num="(13)"> <text>“Sexual abuse” means any act that involves sexual molestation or exploitation of a child by a parent or other person who has permanent or temporary care or custody or responsibility for supervision of a child, or by any household or family member, and includes:</text> <paragraph num="(a)"> <text>Incest, rape, or sexual offense in any degree;</text> </paragraph> <paragraph num="(b)"> <text>Sodomy; and</text> </paragraph> <paragraph num="(c)"> <text>Unnatural or perverted sexual practices.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Requirements."> <paragraph num="A."> <text>A doctor of medicine shall be licensed and legally authorized to practice medicine and surgery in Maryland.</text> </paragraph> <paragraph num="B."> <text>A hospital shall be licensed by the Department as a hospital, pursuant to Hospital and Related Institutions subtitle, Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and shall obtain other licenses as may be required by applicable State and local laws.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conditions for Participation."> <paragraph num="A."> <text>To be reimbursed by the Program, the provider shall:</text> <paragraph num="(1)"> <text>Accept payment by the Program as payment in full for the services rendered to an eligible child and make no additional charge to any person for covered services;</text> </paragraph> <paragraph num="(2)"> <text>Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the child or child's parent or guardian;</text> </paragraph> <paragraph num="(3)"> <text>Provide services without regard to race, creed, color, sex, national origin, marital status, or physical or mental handicap;</text> </paragraph> <paragraph num="(4)"> <text>Maintain records for a minimum of 5 years which are sufficient in detail to support the invoices submitted for payment and make these records available, upon request, to the Department or its designee;</text> </paragraph> <paragraph num="(5)"> <text>Examine or treat any child to determine the nature and extent of any injury as a result of abuse or neglect to the child if the child is brought to the provider:</text> <paragraph num="(a)"> <text>In accordance with a court order;</text> </paragraph> <paragraph num="(b)"> <text>By a police officer who states that the police officer believes the child is an abused child; or</text> </paragraph> <paragraph num="(c)"> <text>By a representative of a local department of social services who states that the representative believes the child is an abused or neglected child.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The provider may not require the consent of the child's parent, guardian, or custodian as a condition of examination or emergency medical treatment.</text> </paragraph> <paragraph num="C."> <text>Immunity from Civil Liability.</text> <paragraph num="(1)"> <text>A physician who examines or treats a child under this chapter is immune from any civil liability that may result from the failure to obtain consent from the child's parents, guardian, or custodian for the examination or treatment of the child.</text> </paragraph> <paragraph num="(2)"> <text>The immunity extends to any:</text> <paragraph num="(a)"> <text>Health care institution with which the physician is affiliated, or to which the child is brought; and</text> </paragraph> <paragraph num="(b)"> <text>Individual working under the control or supervision of the physician or under the control or supervision of the health care institution.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Covered Services."> <text>The Program covers emergency medical treatment rendered to children who are alleged victims of abuse or neglect. This treatment includes:</text> <paragraph num="A."> <text>Medical or surgical care rendered by a physician or health care institution; and</text> </paragraph> <paragraph num="B."> <text>Diagnostic tests.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Limitations."> <text>The Program does not cover the following:</text> <paragraph num="A."> <text>Nonemergency outpatient treatment;</text> </paragraph> <paragraph num="B."> <text>Periodic nonemergency health care;</text> </paragraph> <paragraph num="C."> <text>Services which are investigational or experimental; or</text> </paragraph> <paragraph num="D."> <text>Services related to the assessment and treatment of mental injury.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment Procedures."> <paragraph num="A."> <text>The provider shall submit the request for payment on the appropriate Medical Assistance Program invoice form.</text> </paragraph> <paragraph num="B."> <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department.</text> </paragraph> <paragraph num="C."> <text>Providers shall charge the Program their usual and customary charge to the general public for similar services.</text> </paragraph> <paragraph num="D."> <text>The fee schedule for covered services except hospital services shall be the same as is contained in the Maryland Medical Assistance Program’s Professional Services Provider Manual and Fee Schedule which is incorporated by reference in COMAR 10.09.02.07D.</text> </paragraph> <paragraph num="E."> <text>The reimbursement rates for all covered hospital services shall be the Health Services Cost Review Commission approved rates less the discount allowed the Medical Assistance Program.</text> </paragraph> <paragraph num="F."> <text>For covered services, the Program shall pay the lower of:</text> <paragraph num="(1)"> <text>The provider's usual and customary charge to the general public for similar services; or</text> </paragraph> <paragraph num="(2)"> <text>The applicable rate described in §D or E of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Supplemental payment on Medicare claims shall be made by the Program subject to the following provisions:</text> <paragraph num="(1)"> <text>Deductible insurance shall be paid in full;</text> </paragraph> <paragraph num="(2)"> <text>Coinsurance shall be paid in full;</text> </paragraph> <paragraph num="(3)"> <text>Services not covered by Medicare are payable according to §F of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Payments on Medicare claims shall be authorized if:</text> <paragraph num="(1)"> <text>The provider accepts Medicare assignments;</text> </paragraph> <paragraph num="(2)"> <text>Medicare makes direct payment to the provider;</text> </paragraph> <paragraph num="(3)"> <text>Services are covered by the Program;</text> </paragraph> <paragraph num="(4)"> <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The provider may not bill the Program for:</text> <paragraph num="(1)"> <text>Completion of forms and reports;</text> </paragraph> <paragraph num="(2)"> <text>Professional services rendered by mail or telephone;</text> </paragraph> <paragraph num="(3)"> <text>Services which are provided at no charge to the general public.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Program shall make no direct payment to anyone except providers.</text> </paragraph> <paragraph num="K."> <text>The Program may not reimburse invoices received for payment by the local department of social services more than 90 days after the date of service.</text> </paragraph> <paragraph num="L."> <text>Providers shall bill the Program in the following manner:</text> <paragraph num="(1)"> <text>Claims shall be submitted on appropriate forms;</text> </paragraph> <paragraph num="(2)"> <text>Claims shall be submitted to the local department of social services and shall be received by that department within 90 days of the date of service;</text> </paragraph> <paragraph num="(3)"> <text>A claim which is rejected for payment due to improper completion or incomplete information shall be paid only if it is properly completed, resubmitted, and received by the Program within the original 90-day period or within 60 days of the rejection, whichever is later.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement."> <paragraph num="A."> <text>The child's parent or guardian is liable to the Maryland Department of Health for all payments made on behalf of the child by this Program.</text> </paragraph> <paragraph num="B."> <text>The child's parent or guardian shall take any steps necessary to secure health benefits available for the child from a public or private benefit program.</text> </paragraph> <paragraph num="C."> <text>Upon notification to the provider that the child has insurance or other coverage for services covered by this chapter, the provider shall seek payment from that source.</text> </paragraph> <paragraph num="D."> <text>If payment is made to a provider by both the Program and other insurance or other source, the provider shall refund the Program, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less.</text> </paragraph> <paragraph num="E."> <text>The provider shall reimburse the Program for any overpayments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal Procedures."> <paragraph num="A."> <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to State Government Article, Title 10, Subtitle 2, and Health-General Article, §§2-201—2-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Appeals shall be filed within 30 days of receipt of notice of administrative decisions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Funding Availability."> <text>Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Family Law Article, §§5-701—5-910, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 10, 1986 (13:5 Md. R. 546)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 20, 1997 (24:21 Md. R. 1450)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252)</annotation> </annotations> </chapter> </subtitle> <subtitle num="49" heading="State Anatomy Board"> <chapter num="01" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Anatomy Board.</text> </paragraph> <paragraph num="(2)"> <text>“Cadaveric specimens” means requested body parts, organs, or tissues taken from a cadaver.</text> </paragraph> <paragraph num="(3)"> <text>“In-State commercial programs” means uses of cadaveric specimens at in-State institutions for teaching, training or research using a company's medical products such as an instrument, implant, or other device.</text> </paragraph> <paragraph num="(4)"> <text>“In-State programs” means institutional or government funded, or continuing medical education accredited courses.</text> </paragraph> <paragraph num="(5)"> <text>“In-State study programs” means Maryland medical-dental study programs that use cadavers and cadaveric specimens to conduct:</text> <paragraph num="(a)"> <text>Anatomical disciplinary instruction;</text> </paragraph> <paragraph num="(b)"> <text>Resident surgical, clinical, or allied health training;</text> </paragraph> <paragraph num="(c)"> <text>Physician continuing education training courses and advanced study;</text> </paragraph> <paragraph num="(d)"> <text>Allied health, paramedic, and emergency medical training courses;</text> </paragraph> <paragraph num="(e)"> <text>Research study requiring cadavers or human cadaveric specimens; or</text> </paragraph> <paragraph num="(f)"> <text>Other educational, training, or research programs approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Member school programs” means departments of anatomy of medical-dental schools located in Maryland that use cadavers and cadaveric specimens to support teaching and research studies.</text> </paragraph> <paragraph num="(7)"> <text>“Member schools” means from the Departments of Anatomy of the medical schools in Maryland and the University of Maryland Dental College.</text> </paragraph> <paragraph num="(8)"> <text>“Out-of-State commercial” means uses of cadaveric specimens at out-of-State institutions for teaching, training, or research using a company's medical products such as an instrument, implant, or other device.</text> </paragraph> <paragraph num="(9)"> <text>“Out-of-State study programs” means out-of-State medical-dental study institutions that:</text> <paragraph num="(a)"> <text>Use cadavers and cadaveric specimens to conduct anatomy courses as specified in §B(5) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Are institutional or government funded, or continuing medical education accredited courses.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Reimbursement Claim Fees."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Release an unclaimed body under its control to a relative or friend; and</text> </paragraph> <paragraph num="(2)"> <text>Be reimbursed for expenses incurred for transportation, storage, preparation, cremation, and supplies and materials used.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may, at its discretion, waive the fee under §A(2) of this regulation, based on economic hardship.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Cadaver and Cadaveric Specimen Fees."> <paragraph num="A."> <text>The Board shall review costs of services provided to the State's medical-dental member school programs every 2 years.</text> </paragraph> <paragraph num="B."> <text>Cost Analysis. The Board shall:</text> <paragraph num="(1)"> <text>Perform a cost analysis of expenditures and experienced program services based on activities related to transportation, preparation, and disposition of bodies under its control; and</text> </paragraph> <paragraph num="(2)"> <text>Determine the total average cost per cadaver and cadaveric specimen, based on the cost analysis.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Fees.</text> <paragraph num="(1)"> <text>The fee for member school programs shall be set at a rate not less than 25 percent of the total average cost per cadaver.</text> </paragraph> <paragraph num="(2)"> <text>The fee for in-State study programs shall be set at a rate of not less than one and one-quarter or 125 percent of the average cost per cadaver.</text> </paragraph> <paragraph num="(3)"> <text>The fee for in-State commercial study programs shall be set at a rate of not less than two and one-half or 250 percent of the average cost per cadaver.</text> </paragraph> <paragraph num="(4)"> <text>The fee for out-of-State study programs shall be set at a rate not less than 4 times or 400 percent of the average cost per cadaver.</text> </paragraph> <paragraph num="(5)"> <text>The fee for out-of-State commercial programs shall be set at a rate of not less than 5 times or 500 percent of the average cost per cadaver.</text> </paragraph> <paragraph num="(6)"> <text>The fees for cadaveric specimens shall be set at a rate proportional to the average cost per cadaver in each category listed in §C(1) — (5) of this regulation.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §5-404.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 16, 2002 (29:18 Md. R. 1444)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective April 5, 2010 (37:7 Md. R. 572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective April 5, 2010 (37:7 Md. R. 572)</annotation> </annotations> </chapter> </subtitle> <subtitle num="50" heading="Tissue Banks"> <chapter num="01" heading="Tissue Banks"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The intent of this chapter is to protect the public and individual health by requiring that all tissue banks operating or providing services in Maryland operate under qualified supervision, reliable procedures, and appropriate quality assurance.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter does not apply to a tissue bank operated:</text> <paragraph num="A."> <text>By the federal government; or</text> </paragraph> <paragraph num="B."> <text>Solely for research and teaching purposes, if human tissue and tissue products from the research or teaching are not transplanted, transfused, or used within or upon a human.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adverse outcome” means an undesirable effect or untoward complication in a recipient as a result of or reasonably related to a transfusion or transplantation of cells, tissue, or both.</text> </paragraph> <paragraph num="(2)"> <text>“Allogeneic tissue” means tissue from a human donor intended for use within or upon the body of an individual other than the donor.</text> </paragraph> <paragraph num="(3)"> <text>“Allograft” means cells, tissue, or both intended for transplantation into another individual of the same species.</text> </paragraph> <paragraph num="(4)"> <text>“Approval of the removal plan” means that the OHCQ has determined that the tissue bank's removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.</text> </paragraph> <paragraph num="(5)"> <text>“Autogeneic tissue” means tissue from a human donor intended for use within or upon the body of that same donor.</text> </paragraph> <paragraph num="(6)"> <text>“Cardiovascular tissue” means:</text> <paragraph num="(a)"> <text>Human heart valves;</text> </paragraph> <paragraph num="(b)"> <text>Aorta and great vessels;</text> </paragraph> <paragraph num="(c)"> <text>Pericardium;</text> </paragraph> <paragraph num="(d)"> <text>Saphenous vein;</text> </paragraph> <paragraph num="(e)"> <text>Umbilical vein; or</text> </paragraph> <paragraph num="(f)"> <text>Other tissues of the cardiovascular system.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Collection.</text> <paragraph num="(a)"> <text>“Collection” means an activity involved in obtaining allogeneic or autogeneic tissue for the purpose of transplantation, transfusion, or transfer into or upon a human being.</text> </paragraph> <paragraph num="(b)"> <text>“Collection” includes the removal, acquisition, recovery, harvesting, or retrieval of donor tissue by any means, including:</text> <paragraph num="(i)"> <text>Phlebotomy;</text> </paragraph> <paragraph num="(ii)"> <text>Hemapheresis;</text> </paragraph> <paragraph num="(iii)"> <text>Surgical excision; and</text> </paragraph> <paragraph num="(iv)"> <text>Biopsy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Designated qualified employee” means an employee who has been delegated one or more responsibilities by the technical director or medical director and who possesses the training and experience to perform the delegated responsibility.</text> </paragraph> <paragraph num="(9)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(10)"> <text>“Distribution” means the removal of tissue or tissue products from the tissue bank originally collecting, storing, or processing the tissue for shipment to another person or facility for processing, storage, or a diagnostic, therapeutic, or prophylactic purpose.</text> </paragraph> <paragraph num="(11)"> <text>“Donor” means a human being, living or dead, who is the source of tissue for:</text> <paragraph num="(a)"> <text>Transplantation;</text> </paragraph> <paragraph num="(b)"> <text>Transfer;</text> </paragraph> <paragraph num="(c)"> <text>Transfusion; or</text> </paragraph> <paragraph num="(d)"> <text>Implantation.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Eye” means a human cornea or other ocular tissue.</text> </paragraph> <paragraph num="(13)"> <text>“Hematopoietic progenitor cells” means human precursor stem or progenitor hematopoietic cells derived from bone marrow, peripheral blood, or other tissue sources.</text> </paragraph> <paragraph num="(14)"> <text>“Immediate corrective action” means all actions the tissue bank has taken or will take to immediately address the noncompliance that resulted in or made serious harm or death likely.</text> </paragraph> <paragraph num="(15)"> <text>“Immediate jeopardy” means a situation in which immediate corrective action is necessary because the tissue bank's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious harm or death, to individuals served by the tissue bank or to the health or safety of the general public.</text> </paragraph> <paragraph num="(16)"> <text>“Informal dispute resolution (IDR)” means an informal process that provides a tissue bank the opportunity to dispute one or more deficiencies cited in a written statement of deficiencies issued by the Department or the Department’s designee related to a recent survey.</text> </paragraph> <paragraph num="(17)"> <text>Leukocyte.</text> <paragraph num="(a)"> <text>“Leukocyte” means a nucleated white blood cell or a colorless blood corpuscle that:</text> <paragraph num="(i)"> <text>Is found throughout the human body, including the blood, lymphatic system, and lymphoidal tissue;</text> </paragraph> <paragraph num="(ii)"> <text>Is produced and derived from hematopoietic progenitor cells in the bone marrow; and</text> </paragraph> <paragraph num="(iii)"> <text>Functions to protect the body against infectious microorganisms that cause disease by phagocytosis of the microorganisms and by producing antibodies.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Leukocyte” includes any of the various white blood cells classified as a granulocyte or agranulocyte that collectively make up the human immune system, including:</text> <paragraph num="(i)"> <text>Neutrophils, also known as polymorphonuclear leukocytes;</text> </paragraph> <paragraph num="(ii)"> <text>Eosinophils;</text> </paragraph> <paragraph num="(iii)"> <text>Basophils;</text> </paragraph> <paragraph num="(iv)"> <text>Monocytes;</text> </paragraph> <paragraph num="(v)"> <text>Lymphocytes; and</text> </paragraph> <paragraph num="(vi)"> <text>Thrombocytes, also known as platelets.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>Leukocyte-Poor Tissue.</text> <paragraph num="(a)"> <text>“Leukocyte-Poor tissue” means tissue that does not contain a significant or substantial number of potentially viable leukocytes.</text> </paragraph> <paragraph num="(b)"> <text>“Leukocyte-Poor tissue” includes but is not limited to:</text> <paragraph num="(i)"> <text>Corneas;</text> </paragraph> <paragraph num="(ii)"> <text>Sclera;</text> </paragraph> <paragraph num="(iii)"> <text>Skin;</text> </paragraph> <paragraph num="(iv)"> <text>Heart valves;</text> </paragraph> <paragraph num="(v)"> <text>Dura mater;</text> </paragraph> <paragraph num="(vi)"> <text>Oocytes; and</text> </paragraph> <paragraph num="(vii)"> <text>Musculoskeletal tissue, including bone, tendons, ligaments, and cartilage oocytes, if cleansed, washed, and rendered leukocyte-reduced.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>Leukocyte-Rich Tissue.</text> <paragraph num="(a)"> <text>“Leukocyte-Rich tissue” means tissue that may contain a significant or substantial number of potentially viable leukocytes.</text> </paragraph> <paragraph num="(b)"> <text>“Leukocyte-Rich tissue” includes but is not limited to:</text> <paragraph num="(i)"> <text>Blood, blood components, and products prepared after blood collection;</text> </paragraph> <paragraph num="(ii)"> <text>Hematopoietic progenitor cells, also known as stem cells;</text> </paragraph> <paragraph num="(iii)"> <text>Bone marrow;</text> </paragraph> <paragraph num="(iv)"> <text>Musculoskeletal tissue containing blood or marrow elements, including unprocessed, fresh or frozen, or whole or partial bone;</text> </paragraph> <paragraph num="(v)"> <text>Musculoskeletal tissue allografts in which the bone end and subchondral bone element have not been cleansed, washed, and rendered leukocyte-reduced; and</text> </paragraph> <paragraph num="(vi)"> <text>Semen.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Medical director” means a physician who:</text> <paragraph num="(a)"> <text>Meets the requirements set forth in Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Is responsible for all medical aspects of the tissue bank's operations, unless the technical director meets the qualifications stated in Regulation .10B of this chapter.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Milk” means human milk for ingestion by a child other than the milk donor's child.</text> </paragraph> <paragraph num="(22)"> <text>“Musculoskeletal tissue” means:</text> <paragraph num="(a)"> <text>Bone;</text> </paragraph> <paragraph num="(b)"> <text>Tendon;</text> </paragraph> <paragraph num="(c)"> <text>Ligament;</text> </paragraph> <paragraph num="(d)"> <text>Muscle;</text> </paragraph> <paragraph num="(e)"> <text>Fascia;</text> </paragraph> <paragraph num="(f)"> <text>Cartilage; or</text> </paragraph> <paragraph num="(g)"> <text>Other tissue in the musculoskeletal system.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Need for immediate corrective action” means immediate corrective action is necessary to remove the jeopardy.</text> </paragraph> <paragraph num="(24)"> <text>“Noncompliance” means the tissue bank is not compliant with one or more licensure requirements.</text> </paragraph> <paragraph num="(25)"> <text>“OHCQ” means the Office of Health Care Quality in the Department.</text> </paragraph> <paragraph num="(26)"> <text>“Owner” means a person with an ownership interest in a tissue bank.</text> </paragraph> <paragraph num="(27)"> <text>Permit.</text> <paragraph num="(a)"> <text>“Permit” means a license issued by the Secretary to:</text> <paragraph num="(i)"> <text>Operate a tissue bank in this State; or</text> </paragraph> <paragraph num="(ii)"> <text>Represent or service in this State a tissue bank that is in this State or outside this State.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Permit” includes a provisional permit, except as otherwise indicated in Regulation .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Plan of correction” means a written plan submitted by the tissue bank to the OHCQ which documents steps the tissue bank will take to come into compliance with the licensure requirements.</text> </paragraph> <paragraph num="(29)"> <text>“Processing” means an activity necessary to:</text> <paragraph num="(a)"> <text>Prepare or preserve a tissue for storage;</text> </paragraph> <paragraph num="(b)"> <text>Remove a tissue from storage; or</text> </paragraph> <paragraph num="(c)"> <text>Conduct testing to assure the potency, quality, or sterility of a tissue.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Recipient” means an individual who receives a tissue through:</text> <paragraph num="(a)"> <text>Transplantation;</text> </paragraph> <paragraph num="(b)"> <text>Transfusion;</text> </paragraph> <paragraph num="(c)"> <text>Transfer; or</text> </paragraph> <paragraph num="(d)"> <text>Implementation.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Removal plan” means the tissue bank's written plan that documents:</text> <paragraph num="(a)"> <text>The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;</text> </paragraph> <paragraph num="(b)"> <text>All actions to remove past, present, and future jeopardy; and</text> </paragraph> <paragraph num="(c)"> <text>The date by which the entity asserts the likelihood for serious harm to any recipient no longer exists.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Represent or service” means a mechanism, system, method, or activity that provides or offers to provide a tissue bank service to a person in the State.</text> </paragraph> <paragraph num="(33)"> <text>Reproductive Tissue.</text> <paragraph num="(a)"> <text>“Reproductive tissue” means tissue from the reproductive tract intended for use in artificial insemination or another assisted reproductive procedure.</text> </paragraph> <paragraph num="(b)"> <text>“Reproductive tissue” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Semen;</text> </paragraph> <paragraph num="(ii)"> <text>Oocytes;</text> </paragraph> <paragraph num="(iii)"> <text>Embryos;</text> </paragraph> <paragraph num="(iv)"> <text>Spermatozoa;</text> </paragraph> <paragraph num="(v)"> <text>Spermatids;</text> </paragraph> <paragraph num="(vi)"> <text>Ovarian tissue;</text> </paragraph> <paragraph num="(vii)"> <text>Testicular tissue;</text> </paragraph> <paragraph num="(viii)"> <text>Epididymal aspirates; and</text> </paragraph> <paragraph num="(ix)"> <text>Other tissue in the reproductive system.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(34)"> <text>Quality Control.</text> <paragraph num="(a)"> <text>“Quality control” means the daily analysis of procedures and materials to assure sterility, accuracy, and reproducibility of tissue and tissue bank products.</text> </paragraph> <paragraph num="(b)"> <text>“Quality control” includes a documented system to assure that instruments, equipment, reagents, and supplies function properly.</text> </paragraph> </paragraph> <paragraph num="(35)"> <text>“Secretary” means the Secretary of the Department.</text> </paragraph> <paragraph num="(36)"> <text>“Serious harm” means the situation has already caused, is causing, or is likely to cause, at any time, serious injury, serious impairment, or death, to individuals served by the tissue bank or to the health or safety of the general public.</text> </paragraph> <paragraph num="(37)"> <text>“Storage” means holding tissue for subsequent:</text> <paragraph num="(a)"> <text>Transplantation;</text> </paragraph> <paragraph num="(b)"> <text>Transfusion;</text> </paragraph> <paragraph num="(c)"> <text>Transfer; or</text> </paragraph> <paragraph num="(d)"> <text>Implantation.</text> </paragraph> </paragraph> <paragraph num="(38)"> <text>“Statement of Deficiencies” means the written notification that the OHCQ issues to the provider that contains a listing of deficiencies cited that require correction.</text> </paragraph> <paragraph num="(39)"> <text>“Technical director” means an individual who:</text> <paragraph num="(a)"> <text>Meets the requirements set forth in Regulation .10 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Will oversee and be responsible for all technical aspects of the tissue bank's operations..</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>Tissue.</text> <paragraph num="(a)"> <text>“Tissue” means a visceral or nonvisceral collection of human cells and their associated intracellular substances.</text> </paragraph> <paragraph num="(b)"> <text>“Tissue” includes, but is not limited to, human:</text> <paragraph num="(i)"> <text>Blood, blood components, and products prepared after collection;</text> </paragraph> <paragraph num="(ii)"> <text>Cardiovascular tissue;</text> </paragraph> <paragraph num="(iii)"> <text>Cornea and other ocular tissue;</text> </paragraph> <paragraph num="(iv)"> <text>Hematopoietic progenitor cells;</text> </paragraph> <paragraph num="(v)"> <text>Milk;</text> </paragraph> <paragraph num="(vi)"> <text>Musculoskeletal tissue;</text> </paragraph> <paragraph num="(vii)"> <text>Reproductive cells and tissue; and</text> </paragraph> <paragraph num="(viii)"> <text>Skin.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(41)"> <text>Tissue Bank.</text> <paragraph num="(a)"> <text>“Tissue bank” means an establishment that obtains, stores, processes, distributes, or sells human blood or other human tissue for use in the human body.</text> </paragraph> <paragraph num="(b)"> <text>“Tissue bank” includes a person or facility that provides or engages in one or more services involving tissue from living or cadaveric donors for:</text> <paragraph num="(i)"> <text>Transplantation;</text> </paragraph> <paragraph num="(ii)"> <text>Transfusion;</text> </paragraph> <paragraph num="(iii)"> <text>Transfer; or</text> </paragraph> <paragraph num="(iv)"> <text>Implementation purposes.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Tissue bank” includes, but is not limited to, the following classes:</text> <paragraph num="(i)"> <text>Blood bank;</text> </paragraph> <paragraph num="(ii)"> <text>Cardiovascular tissue bank;</text> </paragraph> <paragraph num="(iii)"> <text>Eye bank;</text> </paragraph> <paragraph num="(iv)"> <text>Hematopoietic progenitor cell bank;</text> </paragraph> <paragraph num="(v)"> <text>Human milk bank;</text> </paragraph> <paragraph num="(vi)"> <text>Musculoskeletal tissue bank;</text> </paragraph> <paragraph num="(vii)"> <text>Reproductive tissue bank; and</text> </paragraph> <paragraph num="(viii)"> <text>Skin bank.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(42)"> <text>Tissue Bank Service.</text> <paragraph num="(a)"> <text>“Tissue bank service” means an activity or pursuit that involves tissue intended for human:</text> <paragraph num="(i)"> <text>Transplantation;</text> </paragraph> <paragraph num="(ii)"> <text>Transfusion;</text> </paragraph> <paragraph num="(iii)"> <text>Transfer; or</text> </paragraph> <paragraph num="(iv)"> <text>Implementation.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Tissue bank service” includes, but is not limited to, an activity or means of donor selection or tissue:</text> <paragraph num="(i)"> <text>Collection;</text> </paragraph> <paragraph num="(ii)"> <text>Preparation;</text> </paragraph> <paragraph num="(iii)"> <text>Preservation;</text> </paragraph> <paragraph num="(iv)"> <text>Storage;</text> </paragraph> <paragraph num="(v)"> <text>Allocation;</text> </paragraph> <paragraph num="(vi)"> <text>Transportation; or</text> </paragraph> <paragraph num="(vii)"> <text>Distribution.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this chapter, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>Standards for Tissue Banking (American Association of Tissue Banks, 14th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only;</text> </paragraph> <paragraph num="(2)"> <text>Standards for Blood Banks and Transfusion Services [(American Association of Blood Banks, 29th Edition);] (Association for the Advancement of Blood & Biotherapies), 34th Edition;</text> </paragraph> <paragraph num="(3)"> <text>International Quality Plasma Program (IQPP) (Plasma Protein Therapeutics Association):</text> <paragraph num="(a)"> <text>Community-based Donor Standard V5 (2020);</text> </paragraph> <paragraph num="(b)"> <text>Cross Donation Management Standard V3 (2014);</text> </paragraph> <paragraph num="(c)"> <text>Recording Donor Adverse Events V2 (2018);</text> </paragraph> <paragraph num="(d)"> <text>Donor Education Standard V3 (2014);</text> </paragraph> <paragraph num="(e)"> <text>Donor Fluid Administration Standard V1 (2014);</text> </paragraph> <paragraph num="(f)"> <text>Use of National Donor Deferral Registry Standard V3 (2008);</text> </paragraph> <paragraph num="(g)"> <text>Qualified Donor Standard V5 (2020);</text> </paragraph> <paragraph num="(h)"> <text>Viral Marker Standard V5 (2022);</text> </paragraph> <paragraph num="(i)"> <text>Personnel Education and Training Standard V5 (2019);</text> </paragraph> <paragraph num="(j)"> <text>Plasma Collection Facility Standard V4 (2019);</text> </paragraph> <paragraph num="(k)"> <text>Quality Assurance Standard V5 (2020); and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>42 U.S.C. §§1320d et seq., as amended;</text> </paragraph> <paragraph num="(5)"> <text>42 U.S.C. §§17921 et seq., as amended; and</text> </paragraph> <paragraph num="(6)"> <text>45 CFR Parts 160, 162, and 164, as amended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of the OHCQ. — Repealed." /> <regulation prefix="Regulation" num=".06" heading="Permitting Procedure."> <paragraph num="A."> <text>Application. An application is not complete until the OHCQ has received the completed permit application and all required documents.</text> </paragraph> <paragraph num="B."> <text>Initial Inspection. The OHCQ shall inspect or have an inspection conducted by an accreditation organization for each tissue bank when an initial Maryland permit to operate is sought.</text> </paragraph> <paragraph num="C."> <text>Issuance of a Permit. The Secretary shall issue a permit to an applicant who meets the requirements of this chapter to:</text> <paragraph num="(1)"> <text>Operate a tissue bank in the State; or</text> </paragraph> <paragraph num="(2)"> <text>Represent for service in the State a tissue bank that is inside the State or outside the State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Issuance of a Permit and Provisional Permit.</text> <paragraph num="(1)"> <text>Permit and Provisional Permit Content. A permit and provisional permit shall state:</text> <paragraph num="(a)"> <text>The name of the tissue bank;</text> </paragraph> <paragraph num="(b)"> <text>The name of the tissue bank's medical director;</text> </paragraph> <paragraph num="(c)"> <text>The name of the tissue bank's owner or owners; and</text> </paragraph> <paragraph num="(d)"> <text>The class or classes of the tissue bank.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provisional Permit.</text> <paragraph num="(a)"> <text>The Secretary may issue a provisional permit before or after an initial inspection.</text> </paragraph> <paragraph num="(b)"> <text>A provisional permit:</text> <paragraph num="(i)"> <text>Is valid for 180 calendar days or a lesser period as determined by the Secretary;</text> </paragraph> <paragraph num="(ii)"> <text>May not be renewed; and</text> </paragraph> <paragraph num="(iii)"> <text>Shall automatically expire without notice upon the sooner of the date set for its expiration or upon issuance of a permit.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Permit Requirement. A person shall hold a permit issued by the Secretary before the person may:</text> <paragraph num="(1)"> <text>Operate a tissue bank in this State; or</text> </paragraph> <paragraph num="(2)"> <text>Represent or service in this State a tissue bank that is:</text> <paragraph num="(a)"> <text>In this State; or</text> </paragraph> <paragraph num="(b)"> <text>Outside this State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Operating Without a Permit.</text> <paragraph num="(1)"> <text>Unless a person has a permit issued by the Secretary to operate, represent, or service a tissue bank in this State, a person may not:</text> <paragraph num="(a)"> <text>Operate a tissue bank in this State; or</text> </paragraph> <paragraph num="(b)"> <text>Represent or service in this State a tissue bank that is in this State or outside this State.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A permit holder may not operate, represent, or service a tissue bank class other than that authorized in the permit.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Cessation of Operations. If a tissue bank ceases operation for 180 calendar days, then:</text> <paragraph num="(1)"> <text>The OHCQ will void the permit to operate a tissue bank in the State; and</text> </paragraph> <paragraph num="(2)"> <text>The tissue bank shall return the permit to the OHCQ.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Permit Application Administratively Closed.</text> <paragraph num="(1)"> <text>After 180 calendar days from the date of initial receipt, the OHCQ may deem an incomplete permit application inactive and administratively close the application.</text> </paragraph> <paragraph num="(2)"> <text>An applicant whose application is administratively closed may reapply for a permit by submitting a new application.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Change of Medical Director, Name, or Location of a Tissue Bank. A tissue bank undergoing a change in medical director, name, or location shall:</text> <paragraph num="(1)"> <text>Notify the OHCQ 10 calendar days before a change occurs; and</text> </paragraph> <paragraph num="(2)"> <text>Apply to the OHCQ for an amended permit or provisional permit within 30 calendar days after a change takes place.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Nontransferability. A permit or provisional permit may not be transferred from one owner of a tissue bank to another.</text> </paragraph> <paragraph num="K."> <text>Denial, Suspension, Revocation — Causes. The Secretary may deny, suspend, or revoke a permit or provisional permit if the tissue bank or the tissue bank's technical director, medical director, or both fail to meet requirements of this chapter, including, but not limited to:</text> <paragraph num="(1)"> <text>Failure within a specified time to correct a cited deficiency identified during an inspection;</text> </paragraph> <paragraph num="(2)"> <text>Repetitive or consistent errors;</text> </paragraph> <paragraph num="(3)"> <text>Deliberate falsehood; or</text> </paragraph> <paragraph num="(4)"> <text>Failure to apply for an amended permit or provisional permit within 30 calendar days after a tissue bank undergoes a change in tissue bank class, medical director, name, or location.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Denial, Suspension, and Revocation — Hearing Requirement.</text> <paragraph num="(1)"> <text>When the Secretary denies an application for a permit, the Secretary shall inform the permit applicant in writing:</text> <paragraph num="(a)"> <text>Of the date the denial takes effect;</text> </paragraph> <paragraph num="(b)"> <text>Of the reason for the denial; and</text> </paragraph> <paragraph num="(c)"> <text>That the permit applicant has an opportunity for a hearing on the matter in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the Secretary finds that a danger to public health, safety, or welfare summarily requires that emergency action be taken to correct a deficiency, the Secretary shall inform the permit holder or provisional permit holder, in writing:</text> <paragraph num="(a)"> <text>Of the date a suspension or revocation of the permit or provisional permit takes effect;</text> </paragraph> <paragraph num="(b)"> <text>Of the reason for the suspension or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>That the permit holder or provisional permit holder has an opportunity for a hearing on the matter before the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When a finding is made that the public health, safety, or welfare summarily requires that emergency or immediate corrective action be taken, the Secretary shall inform the permit holder or provisional permit holder in writing:</text> <paragraph num="(a)"> <text>Of the date a suspension or revocation of the permit or provisional permit takes effect;</text> </paragraph> <paragraph num="(b)"> <text>Of the reason for the suspension or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>That the permit holder or provisional permit holder has an opportunity for a hearing on the matter, after the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Reapplication After Revocation. A tissue bank that has had its permit or provisional permit revoked may apply for a new permit 30 calendar days after revocation and upon presentation to the Secretary of evidence of capability and intention to comply with the standards and requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="M."> <text>Return of Permit. If a tissue bank's permit is amended, suspended, or revoked, the original permit is void and the tissue bank's technical director shall return the permit to the OHCQ.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Accredited Tissue Bank and Accrediting Organization."> <paragraph num="A."> <text>Accredited Tissue Bank — Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the tissue bank accrediting organization are equivalent to those under this chapter.</text> </paragraph> <paragraph num="B."> <text>Accredited Tissue Bank — Requirements. In addition to meeting the requirements for accreditation, as set forth by a tissue bank's accrediting organization, an accredited tissue bank shall:</text> <paragraph num="(1)"> <text>Obtain and maintain a valid permit issued by the Secretary; and</text> </paragraph> <paragraph num="(2)"> <text>Be subject to inspection by the OHCQ to:</text> <paragraph num="(a)"> <text>Determine if the tissue bank is operating in a manner that does not constitute an imminent and serious risk to public health;</text> </paragraph> <paragraph num="(b)"> <text>Investigate complaints;</text> </paragraph> <paragraph num="(c)"> <text>Determine whether a permit holder is operating a tissue bank beyond the scope of the permit;</text> </paragraph> <paragraph num="(d)"> <text>Validate findings of a tissue bank's accrediting organization; and</text> </paragraph> <paragraph num="(e)"> <text>Verify compliance with licensure requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Accrediting Organization.</text> <paragraph num="(1)"> <text>A private, nonprofit tissue-bank accrediting organization may inspect and accredit tissue banks in the State for the purpose of a State permit only after applying for and receiving approval of the OHCQ.</text> </paragraph> <paragraph num="(2)"> <text>The OHCQ may approve a tissue bank accrediting organization based on a review of that organization, if the review includes (but need not be limited to) an evaluation of:</text> <paragraph num="(a)"> <text>Accreditation policies and standards;</text> </paragraph> <paragraph num="(b)"> <text>Copies of inspection forms and guidelines;</text> </paragraph> <paragraph num="(c)"> <text>Inspection and deficiency writing policies;</text> </paragraph> <paragraph num="(d)"> <text>Inspector qualifications; and</text> </paragraph> <paragraph num="(e)"> <text>Complaint investigation policies.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to other requirements set forth in this chapter, an accrediting organization shall provide to the OHCQ:</text> <paragraph num="(a)"> <text>Annually, an updated list containing the names, addresses, and accreditation expiration dates of all tissue banks in the State accredited by the accrediting organization;</text> </paragraph> <paragraph num="(b)"> <text>Within 30 days after conducting an inspection, a certified written or electronic copy of each inspection report covering each tissue bank applying for or maintaining accreditation in the State;</text> </paragraph> <paragraph num="(c)"> <text>At least 30 days before the effective date of the change, written notice of any proposed change to requirements for tissue bank accreditation;</text> </paragraph> <paragraph num="(d)"> <text>Within 30 days after a tissue bank's accreditation expires, written or electronic notice if the tissue bank does not renew its accreditation;</text> </paragraph> <paragraph num="(e)"> <text>Documentation of a complaint and complaint investigation; and</text> </paragraph> <paragraph num="(f)"> <text>On request, a copy of:</text> <paragraph num="(i)"> <text>Inspector qualifications; and</text> </paragraph> <paragraph num="(ii)"> <text>Other information the Secretary may require relating to the regulation of a tissue bank.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>When the Secretary denies accreditation to a tissue-bank accrediting organization, the Secretary shall inform the accrediting agency in writing that it has an opportunity for a hearing under State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Change in Accreditation Status. Tissue banks shall report all changes in accreditation status to the OHCQ within seven calendar days of becoming aware of the change.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inspection by OHCQ."> <paragraph num="A."> <text>Open for Inspection. A permit holder shall allow an on-site inspection by the OHCQ, or any designee by OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, conditions, and standards of this chapter.</text> </paragraph> <paragraph num="B."> <text>Content of Inspection. An inspection may include, but is not limited to, observation and examination of:</text> <paragraph num="(1)"> <text>Tissue bank facilities and physical security;</text> </paragraph> <paragraph num="(2)"> <text>Equipment;</text> </paragraph> <paragraph num="(3)"> <text>Quality assurance and quality control policies and records;</text> </paragraph> <paragraph num="(4)"> <text>Operating procedures, policies, and records;</text> </paragraph> <paragraph num="(5)"> <text>Personnel and personnel records;</text> </paragraph> <paragraph num="(6)"> <text>Donor documentation and records; and</text> </paragraph> <paragraph num="(7)"> <text>Other records and files pertinent to this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Access to Records. Tissue bank employees shall make data and records accessible within a reasonable time during an inspection by OHCQ or any designee by OHCQ.</text> </paragraph> <paragraph num="D."> <text>Permitted Tissue Bank. A permit holder operating a tissue bank under a provisional permit or a permit shall be subject to:</text> <paragraph num="(1)"> <text>An initial inspection conducted by the OHCQ;</text> </paragraph> <paragraph num="(2)"> <text>Periodic inspections by the OHCQ; and</text> </paragraph> <paragraph num="(3)"> <text>Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Accredited Tissue Bank. An accredited tissue bank is subject to:</text> <paragraph num="(1)"> <text>An initial inspection by an accreditation organization or the OHCQ;</text> </paragraph> <paragraph num="(2)"> <text>Periodic inspections by an accreditation organization or the OHCQ; and</text> </paragraph> <paragraph num="(3)"> <text>Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Notice of Deficiencies. If a survey identifies noncompliance with a requirement, the Department shall:</text> <paragraph num="(1)"> <text>Issue a written Statement of Deficiencies that cites each deficiency;</text> </paragraph> <paragraph num="(2)"> <text>Require the tissue bank to submit an acceptable plan of correction within 10 calendar days of receipt of the Statement of Deficiencies;</text> </paragraph> <paragraph num="(3)"> <text>Notify the tissue bank of any sanctions imposed or that failure to correct the violation may result in sanctions; and</text> </paragraph> <paragraph num="(4)"> <text>Offer the tissue bank the opportunity for informal dispute resolution (IDR).</text> </paragraph> </paragraph> <paragraph num="G."> <text>Plan of Correction.</text> <paragraph num="(1)"> <text>The tissue bank shall submit a written plan of correction to the OHCQ in response to a Statement of Deficiencies documenting the steps the permit holder will take to come into compliance, including:</text> <paragraph num="(a)"> <text>How the tissue bank will correct each deficiency;</text> </paragraph> <paragraph num="(b)"> <text>The date by which each deficient practice will be corrected;</text> </paragraph> <paragraph num="(c)"> <text>How the tissue bank will prevent the deficient practice from recurring; and</text> </paragraph> <paragraph num="(d)"> <text>Who will be responsible for ensuring the deficiency will not reoccur.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Failure of the tissue bank to return an acceptable plan of correction within 10 calendar days after receipt of a Statement of Deficiencies may result in a sanction.</text> </paragraph> <paragraph num="(3)"> <text>A tissue bank’s request for an IDR does not change the tissue bank's requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the Statement of Deficiencies.</text> </paragraph> <paragraph num="(4)"> <text>If an immediate jeopardy is identified during a survey, the tissue bank’s plan of correction shall completely correct all noncompliance associated with the immediate jeopardy.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Immediate Jeopardy.</text> <paragraph num="(1)"> <text>Declaration of Immediate Jeopardy.</text> <paragraph num="(a)"> <text>When the Department identifies a situation in which immediate corrective action is necessary because the tissue bank's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious harm or death, to individuals served by the tissue bank or to the health or safety of the general public, an immediate jeopardy will be declared.</text> </paragraph> <paragraph num="(b)"> <text>The Department shall provide the tissue bank a written notice that includes a description of the situation that constitutes an immediate jeopardy.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Removal Plan. The tissue bank shall submit a written removal plan to the Department that includes:</text> <paragraph num="(a)"> <text>The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;</text> </paragraph> <paragraph num="(b)"> <text>All actions to remove past, present, and future jeopardy; and</text> </paragraph> <paragraph num="(c)"> <text>The date by which the entity asserts the likelihood for serious harm to any recipient or the general public will no longer exist.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department’s Review of the Removal Plan.</text> <paragraph num="(a)"> <text>The OHCQ staff shall review the tissue bank's removal plan to determine if the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.</text> </paragraph> <paragraph num="(b)"> <text>The OHCQ shall verify that the tissue bank has implemented the removal plan.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department’s Approval of the Removal Plan. The Department shall approve the removal plan after verifying that all actions the tissue bank took were effective in removing the likelihood that serious harm or death would occur or recur.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Informal Dispute Resolution (IDR).</text> <paragraph num="(1)"> <text>A tissue bank may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.</text> </paragraph> <paragraph num="(2)"> <text>The tissue bank shall submit the request for an IDR to the OHCQ within 10 calendar days of receiving the Statement of Deficiencies.</text> </paragraph> <paragraph num="(3)"> <text>The written request for an IDR shall:</text> <paragraph num="(a)"> <text>Fully describe the disagreement with the Statement of Deficiencies; and</text> </paragraph> <paragraph num="(b)"> <text>Include all accompanying evidence for the OHCQ’s consideration.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>At the discretion of the OHCQ, the IDR may be held in person, by telephone, by video conference, or in writing.</text> </paragraph> <paragraph num="(5)"> <text>IDRs are informal in nature and may not be attended by legal counsel representing the tissue bank or the Department.</text> </paragraph> <paragraph num="(6)"> <text>The IDR process may not delay the effective date of any enforcement action.</text> </paragraph> <paragraph num="(7)"> <text>In the event a tissue bank requests an IDR for a Statement of Deficiencies written by a designee of the Department, the Department shall request the designee to participate in the IDR process.</text> </paragraph> <paragraph num="(8)"> <text>There is no appeal of the Department’s decision in an IDR.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Process of Filing a Complaint. The tissue bank shall have a written process that describes how donors and recipients of tissue bank services are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Tissue Bank Standards — General."> <paragraph num="A."> <text>Applicable Laws. A tissue bank shall comply with all requirements and standards in this chapter as well as with other applicable federal, State, and local laws, regulations, and rules.</text> </paragraph> <paragraph num="B."> <text>Governing Body. Unless provided by the institution of which it is a part, a tissue bank shall have a governing body consisting of individuals from various professions, that determines the scope of activities to be pursued by the tissue bank and is responsible for issues of:</text> <paragraph num="(1)"> <text>Liability;</text> </paragraph> <paragraph num="(2)"> <text>Ethical considerations;</text> </paragraph> <paragraph num="(3)"> <text>Fiduciary responsibility; and</text> </paragraph> <paragraph num="(4)"> <text>Compliance with the standards and requirements of this chapter and those of the tissue bank's standard operating procedure manual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Facilities.</text> <paragraph num="(1)"> <text>General. The physical facilities of a tissue bank shall meet all applicable federal, State, and local laws, including but not limited to:</text> <paragraph num="(a)"> <text>Engineering;</text> </paragraph> <paragraph num="(b)"> <text>Fire;</text> </paragraph> <paragraph num="(c)"> <text>Safety;</text> </paragraph> <paragraph num="(d)"> <text>Health; and</text> </paragraph> <paragraph num="(e)"> <text>Sanitation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Physical Plant. The physical plant of a tissue bank shall be designed or arranged to meet operational needs with plumbing, drainage, lighting, ventilation, space, and handwashing facilities for personnel and donors if applicable.</text> </paragraph> <paragraph num="(3)"> <text>Designated Space. Personnel of a tissue bank shall perform the following critical tissue bank procedures in designated areas:</text> <paragraph num="(a)"> <text>Processing;</text> </paragraph> <paragraph num="(b)"> <text>Quarantine storage of in-process materials;</text> </paragraph> <paragraph num="(c)"> <text>Other quarantining;</text> </paragraph> <paragraph num="(d)"> <text>Labeling;</text> </paragraph> <paragraph num="(e)"> <text>Storage of distributable inventory;</text> </paragraph> <paragraph num="(f)"> <text>Quality assurance and control functions;</text> </paragraph> <paragraph num="(g)"> <text>Receipt and storage of containers, supplies, and reagents;</text> </paragraph> <paragraph num="(h)"> <text>Storage of medical waste;</text> </paragraph> <paragraph num="(i)"> <text>Irradiation and other sterilization procedures; and</text> </paragraph> <paragraph num="(j)"> <text>Final product inspection and distribution activities.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Tissue Bank Standards — Personnel."> <paragraph num="A."> <text>General Requirements. A tissue bank shall employ a technical director, medical director, and sufficient staff to:</text> <paragraph num="(1)"> <text>Provide accurate and reliable services;</text> </paragraph> <paragraph num="(2)"> <text>Meet all operational needs; and</text> </paragraph> <paragraph num="(3)"> <text>Meet all statutory and regulatory requirements and standards.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Medical Director.</text> <paragraph num="(1)"> <text>Qualifications. The medical director:</text> <paragraph num="(a)"> <text>Shall be a physician licensed to practice medicine by the:</text> <paragraph num="(i)"> <text>Maryland Board of Physicians; or</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate agency in the state where the tissue bank is located; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Shall be qualified by training and experience in evaluating and determining donor suitability, particularly with regard to infectious diseases.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Serving as Technical Director. The medical director may serve also as the technical director if the medical director remains at the tissue bank site during the tissue bank's regular hours of operation.</text> </paragraph> <paragraph num="(3)"> <text>Responsibilities. The medical director shall be responsible for all medical aspects of the tissue bank's operations and shall retain overall responsibility when a task is delegated to a designated qualified employee. The medical director or the designated qualified employee shall:</text> <paragraph num="(a)"> <text>Establish donor suitability criteria;</text> </paragraph> <paragraph num="(b)"> <text>Evaluate and determine each donor's acceptability;</text> </paragraph> <paragraph num="(c)"> <text>Review and approve the standard operating procedures, quality assurance policies, and quality control records for medical efficacy;</text> </paragraph> <paragraph num="(d)"> <text>Approve exceptional or extraordinary releases of tissue as specified in the tissue bank's standard operating procedure manual;</text> </paragraph> <paragraph num="(e)"> <text>Establish policies and procedures regarding adverse outcomes that include requiring that all potential adverse outcomes are:</text> <paragraph num="(i)"> <text>Investigated;</text> </paragraph> <paragraph num="(ii)"> <text>Documented;</text> </paragraph> <paragraph num="(iii)"> <text>Reviewed; and</text> </paragraph> <paragraph num="(iv)"> <text>Reported as required by applicable federal, State, or local law;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Notify the living donor or, for a cadaveric donor, the cadaveric donor's physician for any legally allowed counseling of next of kin, of confirmed positive infectious disease test results;</text> </paragraph> <paragraph num="(g)"> <text>Notify the OHCQ in writing or electronically of each fatal adverse outcome related to:</text> <paragraph num="(i)"> <text>Transplantation;</text> </paragraph> <paragraph num="(ii)"> <text>Transfusion;</text> </paragraph> <paragraph num="(iii)"> <text>Transfer; or</text> </paragraph> <paragraph num="(iv)"> <text>Implementation of tissue; and</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Establish look back and recall procedures when tissue is determined to:</text> <paragraph num="(i)"> <text>Be defective; or</text> </paragraph> <paragraph num="(ii)"> <text>May potentially cause an adverse outcome.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Technical Director.</text> <paragraph num="(1)"> <text>Qualifications. The technical director shall be qualified by training and experience for the scope of activities being pursued and have:</text> <paragraph num="(a)"> <text>A bachelor's or higher degree in medical technology or a biological science from an accredited college or university and be qualified by training and experience for the scope of activities conducted by the tissue bank;</text> </paragraph> <paragraph num="(b)"> <text>A bachelor’s degree in a discipline other than medical technology or a biological science from an accredited college or university and have 5 years of experience overseeing all technical aspects of tissue bank operations under the supervision of a medical director; or</text> </paragraph> <paragraph num="(c)"> <text>Licensure as a registered nurse in the state that the tissue bank is operating.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Responsibilities. The technical director shall oversee and be responsible for all technical aspects of the tissue bank's operations and shall retain overall responsibility when a task is delegated to a designated qualified employee. The technical director or designated qualified employee shall:</text> <paragraph num="(a)"> <text>Provide on-site supervision of tissue bank operations and personnel during the tissue bank's regular hours of operation; and</text> </paragraph> <paragraph num="(b)"> <text>Participate in and actively supervise the tissue bank's:</text> <paragraph num="(i)"> <text>Planning;</text> </paragraph> <paragraph num="(ii)"> <text>Organization;</text> </paragraph> <paragraph num="(iii)"> <text>Staffing;</text> </paragraph> <paragraph num="(iv)"> <text>Training and continuing education;</text> </paragraph> <paragraph num="(v)"> <text>Staff competency;</text> </paragraph> <paragraph num="(vi)"> <text>Quality control and quality assurance;</text> </paragraph> <paragraph num="(vii)"> <text>Standard operating procedures (SOPs);</text> </paragraph> <paragraph num="(viii)"> <text>Facilities;</text> </paragraph> <paragraph num="(ix)"> <text>Donor selection;</text> </paragraph> <paragraph num="(x)"> <text>Equipment;</text> </paragraph> <paragraph num="(xi)"> <text>Products;</text> </paragraph> <paragraph num="(xii)"> <text>Records;</text> </paragraph> <paragraph num="(xiii)"> <text>Services; and</text> </paragraph> <paragraph num="(xiv)"> <text>Compliance with the requirements and standards of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Technical Staff.</text> <paragraph num="(1)"> <text>Qualifications.</text> <paragraph num="(a)"> <text>Technical staff shall possess the education, experience, and training necessary and sufficient to assure that assigned tasks are performed in accordance with the tissue bank's established procedures and the standards set forth in this chapter.</text> </paragraph> <paragraph num="(b)"> <text>The technical director or the designated qualified employee, and medical director or the designated qualified employee shall train individual staff to accurately and reliably:</text> <paragraph num="(i)"> <text>Perform tissue bank services such as collection, retrieval, processing, packaging, and cryopreservation; and</text> </paragraph> <paragraph num="(ii)"> <text>Document that training in the individual's employee training file.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Responsibilities.</text> <paragraph num="(a)"> <text>Technical staff shall implement, maintain, and follow the policies and procedures established by the medical director and technical directors.</text> </paragraph> <paragraph num="(b)"> <text>A technical director or the designated qualified employee shall list and describe the duties and responsibilities of technical staff in written job descriptions.</text> </paragraph> <paragraph num="(c)"> <text>Technical staff shall initially, and at least annually thereafter, demonstrate documented competency in the tasks to which the staff person is assigned.</text> </paragraph> <paragraph num="(d)"> <text>Technical staff shall participate in documented training and continuing education to maintain technical competency in the duties described in their written job descriptions.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Tissue Bank Standards — Testing to Minimize Disease Transmission."> <paragraph num="A."> <text>Required Testing.</text> <paragraph num="(1)"> <text>General — All Donors. A permit holder shall ensure that a prospective donor of tissue, including both leukocyte-rich and leukocyte-poor cell and tissue, intended to be used as an allograft is tested for biochemical, immunological, or serological evidence of:</text> <paragraph num="(a)"> <text>Hepatitis B virus (HBV);</text> </paragraph> <paragraph num="(b)"> <text>Hepatitis C virus (HCV);</text> </paragraph> <paragraph num="(c)"> <text>Human immunodeficiency virus type 1 (HIV-1);</text> </paragraph> <paragraph num="(d)"> <text>Human immunodeficiency virus type 2 (HIV-2); and</text> </paragraph> <paragraph num="(e)"> <text>Treponema pallidum (syphilis).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Specific — Donors of Specific Tissue or Cell Types.</text> <paragraph num="(a)"> <text>In addition to those tests set forth in §A(1) of this regulation, a permit holder shall ensure that a prospective donor of specific types of tissue are tested in accordance with the requirements set forth in §A(2)(b)—(c) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>Donors of Leukocyte-Rich Tissue. A permit holder shall ensure that a prospective donor of a leukocyte-rich tissue, as defined in Regulation .03B of this chapter, intended to be used as an allograft, is tested for biochemical, immunological, or serological evidence of:</text> <paragraph num="(i)"> <text>Human T-lymphotropic virus type I (HTLV-I);</text> </paragraph> <paragraph num="(ii)"> <text>Human T-lymphotropic virus type II (HTLV-II); and</text> </paragraph> <paragraph num="(iii)"> <text>Cytomegalovirus (CMV).</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Donors of Reproductive Tissue including Oocytes and Semen. In addition to those applicable tests set forth in §A(1) and (2)(a) of this regulation, a permit holder shall ensure that a prospective donor of reproductive tissue, as defined in Regulation .03B of this chapter, intended to be used as an allograft, is tested for biochemical, immunological, or serological evidence of:</text> <paragraph num="(i)"> <text>Chlamydia trachomatis; and</text> </paragraph> <paragraph num="(ii)"> <text>Neisseria gonorrhoeae.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Required Laboratory Licensure.</text> <paragraph num="(1)"> <text>In-House Testing Services. A tissue bank that conducts its own testing on human specimens shall possess a Maryland license to operate a medical laboratory and comply with all applicable standards as set forth in COMAR 10.10.01—10.10.08.</text> </paragraph> <paragraph num="(2)"> <text>Contractual Testing Services. A tissue bank that contracts for laboratory testing services shall obtain and maintain:</text> <paragraph num="(a)"> <text>The name and address of a contracted facility and documentation of the inclusive dates of the contract period; and</text> </paragraph> <paragraph num="(b)"> <text>Proof of the contracted facility's current:</text> <paragraph num="(i)"> <text>Federal certification;</text> </paragraph> <paragraph num="(ii)"> <text>Required State laboratory licensure; and</text> </paragraph> <paragraph num="(iii)"> <text>Accreditation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Other Testing Services. A tissue bank that obtains test results from a noncontracted laboratory, for example, another tissue bank or an organ retrieval organization, shall obtain and maintain the name, address, and licensing and accreditation information for each laboratory from which test results are obtained for the purpose of donor assessment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Confidentiality and Release of Test Results. A technical director of a tissue bank may release results of laboratory tests performed by the tissue bank holding a medical laboratory license or performed for the tissue bank by another licensed laboratory only:</text> <paragraph num="(1)"> <text>To:</text> <paragraph num="(a)"> <text>The medical director of the tissue bank;</text> </paragraph> <paragraph num="(b)"> <text>An authorized person who requested the test; or</text> </paragraph> <paragraph num="(c)"> <text>Another laboratory that requested the test as set forth under COMAR 10.10.06.04; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>As allowed under the:</text> <paragraph num="(a)"> <text>Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Federal:</text> <paragraph num="(i)"> <text>Health Insurance Portability and Accountability Act (HIPAA), 42 U.S.C. §§1320d et seq.;</text> </paragraph> <paragraph num="(ii)"> <text>Health Information Technology for Economic and Clinical Health (HITECH) Act, 42 U.S.C. §§17921 et seq.; and</text> </paragraph> <paragraph num="(iii)"> <text>Implementing rules and regulations for HIPAA and the HITECH Act set forth at 45 CFR Parts 160, 162, and 164.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Tissue Bank Standards — Technical."> <text>In addition to the requirements and standards in this chapter, a tissue bank shall meet and comply, where applicable, with the following technical requirements and standards:</text> <paragraph num="A."> <text>Records management, in the manner prescribed in Section C of Standards for Tissue Banking;</text> </paragraph> <paragraph num="B."> <text>Tissue acquisition, in the manner prescribed in Section D of Standards for Tissue Banking;</text> </paragraph> <paragraph num="C."> <text>Processing, preservation, quarantine, and storage, in the manner prescribed in Section E of Standards for Tissue Banking;</text> </paragraph> <paragraph num="D."> <text>Release and transfer of tissue, in the manner prescribed in Section F of Standards for Tissue Banking;</text> </paragraph> <paragraph num="E."> <text>Labeling, in the manner prescribed in Section G of Standards for Tissue Banking;</text> </paragraph> <paragraph num="F."> <text>Distribution and dispensing, in the manner prescribed in Section H of Standards for Tissue Banking;</text> </paragraph> <paragraph num="G."> <text>General operations, in the manner prescribed in Section J of Standards for Tissue Banking;</text> </paragraph> <paragraph num="H."> <text>Quality assurance, in the manner prescribed in Section K of Standards for Tissue Banking;</text> </paragraph> <paragraph num="I."> <text>Tissue dispensing services, in the manner prescribed in Section L of Standards for Tissue Banking;</text> </paragraph> <paragraph num="J."> <text>Tissue distribution intermediaries, in the manner prescribed in subsections M1-8 of Standards for Tissue Banking; and</text> </paragraph> <paragraph num="K."> <text>Standards for Blood Banks and Transfusion Services.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 1970</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and new Regulations .01—.06 adopted effective May 5, 1986 (13:9 Md. R. 1030)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective June 11, 1990 (17:11 Md. R. 1343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective March 20, 1989 (16:5 Md. R. 629); amended and recodified to Regulation .07 effective June 11, 1990 (17:11 Md. R. 1343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective March 20, 1989 (16:5 Md. R. 629); recodified to Regulation .06D effective June 11, 1990 (17:11 Md. R. 1343)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective June 11, 1990 (17:11 Md. R. 1343)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.10.02 recodified to COMAR 10.50.01 effective December 13, 1999 (26:25 Md. R. 1897)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed and new Regulations .01—.12 adopted effective March 15, 2004 (31:5 Md. R. 449)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 4, 2011 (38:7 Md. R. 432); September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 4, 2011 (38:7 Md. R. 432); August 15, 2016 (43:16 Md. R. 901); September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 25, 2013 (40:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D adopted effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 recodified to be Regulation .09 effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 recodified from Regulation .08 effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective January 9, 2012 (38:27 Md. R. 1764)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A, C amended effective April 4, 2011 (38:7 Md. R. 432)</annotation> </annotations> </chapter> </subtitle> <subtitle num="51" heading="Forensic Laboratories"> <chapter num="01" heading="General"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>The intent of this subtitle is to require a forensic laboratory to:</text> <paragraph num="A."> <text>Employ qualified employees; and</text> </paragraph> <paragraph num="B."> <text>Operate and perform forensic analyses under:</text> <paragraph num="(1)"> <text>Reliable procedures;</text> </paragraph> <paragraph num="(2)"> <text>Effective quality control and quality assurance programs; and</text> </paragraph> <paragraph num="(3)"> <text>Qualified supervision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <paragraph num="A."> <text>This subtitle contains the standards and requirements that a forensic laboratory shall meet to obtain and retain a license to perform or offer to perform forensic analyses.</text> </paragraph> <paragraph num="B."> <text>This subtitle does not apply to a:</text> <paragraph num="(1)"> <text>Forensic laboratory operated by the federal government; or</text> </paragraph> <paragraph num="(2)"> <text>Laboratory licensed or certified by the Maryland Department of Agriculture.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Forensic analysis does not include:</text> <paragraph num="(1)"> <text>A test of a specimen of breath or blood to determine alcohol concentration or controlled dangerous substance content;</text> </paragraph> <paragraph num="(2)"> <text>Forensic information technology;</text> </paragraph> <paragraph num="(3)"> <text>A presumptive test performed at a crime scene;</text> </paragraph> <paragraph num="(4)"> <text>A presumptive test performed for the purpose of determining compliance with a term or condition of community supervision or parole and conducted by or under contract with a county department of corrections or the Department of Public Safety and Correctional Services; or</text> </paragraph> <paragraph num="(5)"> <text>An expert examination or test conducted principally for the purpose of scientific research, medical practice, civil or administrative litigation, or any purpose other than determining the connection of physical evidence to a criminal act.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Accuracy.</text> <paragraph num="(a)"> <text>“Accuracy” means the degree of agreement between the determination of a quantity and the quantity’s true value.</text> </paragraph> <paragraph num="(b)"> <text>“Accuracy” includes the quality of a test result as it relates to the analytic phase of the testing process when the test result:</text> <paragraph num="(i)"> <text>Conforms exactly to a standard; or</text> </paragraph> <paragraph num="(ii)"> <text>Deviates only within established limits from a standard.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Administrative Documentation.</text> <paragraph num="(a)"> <text>“Administrative documentation” means a type of laboratory record.</text> </paragraph> <paragraph num="(b)"> <text>“Administrative documentation” includes but is not limited to:</text> <paragraph num="(i)"> <text>Case-related conversations and communications;</text> </paragraph> <paragraph num="(ii)"> <text>Evidence receipts;</text> </paragraph> <paragraph num="(iii)"> <text>Description of evidence packaging and seals;</text> </paragraph> <paragraph num="(iv)"> <text>Incident reports;</text> </paragraph> <paragraph num="(v)"> <text>Service request documentation;</text> </paragraph> <paragraph num="(vi)"> <text>Case-related correspondence including emails and letters;</text> </paragraph> <paragraph num="(vii)"> <text>Interim and preliminary reports;</text> </paragraph> <paragraph num="(viii)"> <text>Case-related database search documentation; and</text> </paragraph> <paragraph num="(ix)"> <text>Other pertinent information pertaining to a forensic analysis, a forensic analysis report, or an analyst’s conclusion.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Administrative review” means an evaluation of a report and supporting documentation for editorial correctness and consistency with laboratory policies.</text> </paragraph> <paragraph num="(4)"> <text>“Alternative sanction” means a sanction that is:</text> <paragraph num="(a)"> <text>Not a principal sanction; and</text> </paragraph> <paragraph num="(b)"> <text>Imposed by the Secretary against a forensic laboratory and includes a directed plan of correction or a limitation on testing services.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Analyst” means an individual who:</text> <paragraph num="(a)"> <text>Performs casework-related duties on items of evidence within the laboratory and issues reports containing opinions or interpretations concerning the resulting findings and observations; or</text> </paragraph> <paragraph num="(b)"> <text>Conducts or directs the analysis of forensic casework samples, interprets data, and reaches conclusions.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Analyte” means a substance or constituent for which a forensic laboratory conducts testing.</text> </paragraph> <paragraph num="(7)"> <text>“Approved proficiency test provider” means an external proficiency test provider who has been approved by the Department as set forth in COMAR 10.51.04.03.</text> </paragraph> <paragraph num="(8)"> <text>“Assessment” means a review of a laboratory’s activities to determine compliance with a set of requirements established by an accrediting organization.</text> </paragraph> <paragraph num="(9)"> <text>Audit.</text> <paragraph num="(a)"> <text>“Audit” means an on-site visit to or survey of a forensic laboratory by the Department to determine a forensic laboratory’s compliance with:</text> <paragraph num="(i)"> <text>Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>The applicable regulations of this subtitle.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Audit” includes but is not limited to:</text> <paragraph num="(i)"> <text>An inspection;</text> </paragraph> <paragraph num="(ii)"> <text>A follow-up inspection;</text> </paragraph> <paragraph num="(iii)"> <text>A complaint investigation; and</text> </paragraph> <paragraph num="(iv)"> <text>On-site monitoring.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Calibration” means the set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material and the corresponding known values of the material.</text> </paragraph> <paragraph num="(11)"> <text>“Calibrator” means a material having a known value or concentration that is traceable to the International System of Units standard, if available, as required by the:</text> <paragraph num="(a)"> <text>Manufacturer of the instrumentation; or</text> </paragraph> <paragraph num="(b)"> <text>Forensic laboratory’s quality assurance program.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Case file” means the part of the case record that is a file containing administrative and examination documentation generated or received by laboratory employees pertaining to a uniquely identified case.</text> </paragraph> <paragraph num="(13)"> <text>Case Notes.</text> <paragraph num="(a)"> <text>“Case notes” means the component of examination documents that is used to support an analyst’s conclusions.</text> </paragraph> <paragraph num="(b)"> <text>“Case notes” includes, but is not limited to, notes, charts, graphs, photographs, and other documents created for documenting the:</text> <paragraph num="(i)"> <text>Procedures, standards, controls, and instruments used for a forensic analysis;</text> </paragraph> <paragraph num="(ii)"> <text>Observations made for a forensic analysis or examination;</text> </paragraph> <paragraph num="(iii)"> <text>Basis or grounds for an analyst’s conclusions; and</text> </paragraph> <paragraph num="(iv)"> <text>Results of performed forensic analyses.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>Case Record.</text> <paragraph num="(a)"> <text>“Case record” means examination and administration documentation received or generated by the laboratory pertaining to a uniquely identified case.</text> </paragraph> <paragraph num="(b)"> <text>“Case record” includes a case file and other laboratory records that are pertinent to forensic analyses and conclusions of a particular case.</text> </paragraph> <paragraph num="(c)"> <text>“Case record” is not limited to a case file.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Case report” means a final, formal report that is signed by the analyst or examiner and issued by a forensic laboratory.</text> </paragraph> <paragraph num="(16)"> <text>“Casework” means the forensic analysis of evidence submitted to a forensic laboratory.</text> </paragraph> <paragraph num="(17)"> <text>“Chain of custody” means the documented movement and location, including the custody, control, and transfer, of physical evidence, from the time the evidence is received until the final disposition of the evidence by the forensic laboratory.</text> </paragraph> <paragraph num="(18)"> <text>“Comparative analyses” means the examination of two or more items to determine the commonality of physical or chemical characteristics of the items.</text> </paragraph> <paragraph num="(19)"> <text>Competency.</text> <paragraph num="(a)"> <text>“Competency” means the:</text> <paragraph num="(i)"> <text>Demonstrated and documented ability of an individual to perform assigned work in a discipline or subdiscipline, in accordance with a licensee’s technical procedures and training manuals, before the performance of independent casework under the authorization of a forensic laboratory director; and</text> </paragraph> <paragraph num="(ii)"> <text>State or quality of being qualified and having the ability to perform a specific task, job, or role.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Competency” includes:</text> <paragraph num="(i)"> <text>Possessing the requisite knowledge, skills, and abilities to perform a task, job, or role; and</text> </paragraph> <paragraph num="(ii)"> <text>Utilizing the requisite combination of knowledge, skill, and demonstration of knowledge necessary to produce satisfactory performance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Competency assessment” means a formal, standardized evaluation of an individual’s ability to perform a specific assigned task, job, or role.</text> </paragraph> <paragraph num="(21)"> <text>“Complaint investigation” means an investigation of a forensic laboratory, which may include an on-site audit conducted by the Department, based on a complaint or allegation of regulatory noncompliance.</text> </paragraph> <paragraph num="(22)"> <text>Contamination Record.</text> <paragraph num="(a)"> <text>“Contamination record” means a record of contamination as defined in the Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference.</text> </paragraph> <paragraph num="(b)"> <text>“Contamination record” includes:</text> <paragraph num="(i)"> <text>A unique case identifier;</text> </paragraph> <paragraph num="(ii)"> <text>Encoded sample identification;</text> </paragraph> <paragraph num="(iii)"> <text>A description of results; and</text> </paragraph> <paragraph num="(iv)"> <text>Identifiers that led to an incident report.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I through V as set forth in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“Customer” means a person authorized by statute, which includes a law enforcement agency, prosecutor, criminal suspect, defendant or defendant’s legal representative, or court, making a request for forensic laboratory services.</text> </paragraph> <paragraph num="(25)"> <text>“Data integrity” means the condition existing when data is unchanged from its source and has not been accidentally or maliciously modified, altered, or destroyed during any operation, such as transfer, storage, or retrieval.</text> </paragraph> <paragraph num="(26)"> <text>“Deficiency” means a finding of statutory or regulatory noncompliance.</text> </paragraph> <paragraph num="(27)"> <text>“Deficiency statement” means a report provided to a forensic laboratory subsequent to an audit conducted by:</text> <paragraph num="(a)"> <text>The forensic laboratory’s accrediting organization; or</text> </paragraph> <paragraph num="(b)"> <text>The Department.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(29)"> <text>“Department of Agriculture” means the Maryland Department of Agriculture.</text> </paragraph> <paragraph num="(30)"> <text>“Directed plan of correction” means a sanction that consists of a set of corrective actions stipulated by the Secretary for a forensic laboratory to implement to effect statutory or regulatory compliance.</text> </paragraph> <paragraph num="(31)"> <text>Discipline.</text> <paragraph num="(a)"> <text>“Discipline” means a major area of forensic science in which a forensic laboratory is licensed to perform or offers to perform forensic analyses.</text> </paragraph> <paragraph num="(b)"> <text>“Discipline” includes:</text> <paragraph num="(i)"> <text>Controlled dangerous substances, including the subdisciplines of pharmaceutical and illicit drugs and other controlled dangerous substances;</text> </paragraph> <paragraph num="(ii)"> <text>Toxicology, including the subdisciplines of forensic toxicology and postmortem toxicology;</text> </paragraph> <paragraph num="(iii)"> <text>Biology, including the subdisciplines of DNA analysis and serology;</text> </paragraph> <paragraph num="(iv)"> <text>Trace evidence, including but not limited to the subdisciplines of adhesives, analysis of unknowns, explosives and explosive debris, fuels, hairs, fibers and textiles, polymers, fire debris, glass, gunshot residue, metal and alloys, paint, and physical comparisons;</text> </paragraph> <paragraph num="(v)"> <text>Firearms and toolmarks, including all subdisciplines of firearms and toolmarks examinations;</text> </paragraph> <paragraph num="(vi)"> <text>Latent prints, including the subdisciplines of latent print processing, latent print comparison, and impressions;</text> </paragraph> <paragraph num="(vii)"> <text>Questioned documents, including the subdisciplines of handwriting, paper, and questioned documents;</text> </paragraph> <paragraph num="(viii)"> <text>Forensic pathology;</text> </paragraph> <paragraph num="(ix)"> <text>Forensic entomology; and</text> </paragraph> <paragraph num="(x)"> <text>Forensic odontology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Discrepancy logs” means a system used by a forensic laboratory to document administrative or processing errors related to evidence and tracked within a case record.</text> </paragraph> <paragraph num="(33)"> <text>Discriminate or Retaliate.</text> <paragraph num="(a)"> <text>“Discriminate or retaliate” means any adverse action taken by a licensee or a licensee’s employee against a forensic laboratory employee who in good faith reports a data integrity issue or unethical or fraudulent conduct, as set forth in this subtitle and Health-General Article, §17–2A–10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Discriminate or retaliate” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Failing to promote an individual or provide another employment-related benefit for which the individual would otherwise be eligible;</text> </paragraph> <paragraph num="(ii)"> <text>Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the individual; or</text> </paragraph> <paragraph num="(iii)"> <text>Taking a personnel action that is adverse to the individual concerned.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(34)"> <text>“DNA” means deoxyribonucleic acid.</text> </paragraph> <paragraph num="(35)"> <text>“Document” means a written, printed, or electronic format.</text> </paragraph> <paragraph num="(36)"> <text>Electronic Record.</text> <paragraph num="(a)"> <text>“Electronic record” means a record created, generated, sent, communicated, received, or stored by electronic means in a format that may be:</text> <paragraph num="(i)"> <text>Optical;</text> </paragraph> <paragraph num="(ii)"> <text>Magnetic; or</text> </paragraph> <paragraph num="(iii)"> <text>Digital.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Electronic record” includes any record that contains information readable by a computer or machine rather than an individual.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record.</text> </paragraph> <paragraph num="(38)"> <text>“Evidence” means a thing or component of a thing that:</text> <paragraph num="(a)"> <text>Is detectable by sensory, physical, chemical, optical, or electronic means; and</text> </paragraph> <paragraph num="(b)"> <text>Provides factual information related to a crime.</text> </paragraph> </paragraph> <paragraph num="(39)"> <text>“Examination” means an analysis of evidence, which may include a visual, physical, or chemical analysis.</text> </paragraph> <paragraph num="(40)"> <text>“Examination documentation” means notes, including a description of the evidence, reference to procedures followed, tests conducted, standards and controls used, diagrams, printouts, photographs, observations, and results of examinations.</text> </paragraph> <paragraph num="(41)"> <text>“Examiner” means an individual who:</text> <paragraph num="(a)"> <text>Performs casework-related duties on items of evidence within the laboratory and issues reports containing opinions or interpretations concerning the resulting findings and observations; or</text> </paragraph> <paragraph num="(b)"> <text>Conducts or directs the analysis of forensic casework samples, interprets data, and reaches conclusions.</text> </paragraph> </paragraph> <paragraph num="(42)"> <text>External Control.</text> <paragraph num="(a)"> <text>“External control” means a test or examination performed on an external test sample to demonstrate a procedure is working correctly.</text> </paragraph> <paragraph num="(b)"> <text>“External control” uses an external test sample that:</text> <paragraph num="(i)"> <text>Is not part of the analytical system;</text> </paragraph> <paragraph num="(ii)"> <text>Contains a known quantity of the analyte being tested;</text> </paragraph> <paragraph num="(iii)"> <text>Is similar in its physical characteristics and constituents to samples tested by the system; and</text> </paragraph> <paragraph num="(iv)"> <text>Reacts with all system components in the same way as a test sample.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(43)"> <text>“External proficiency test” means an analysis performed on a proficiency testing sample provided to a forensic laboratory by an approved proficiency testing provider external to the laboratory or laboratory system.</text> </paragraph> <paragraph num="(44)"> <text>Forensic Analysis.</text> <paragraph num="(a)"> <text>“Forensic analysis” means a medical, chemical, toxicological, firearms, or other expert examination or test performed on physical evidence, including DNA evidence, for the purpose of determining the connection of the evidence to a criminal act.</text> </paragraph> <paragraph num="(b)"> <text>“Forensic analysis” includes an examination or test required by a:</text> <paragraph num="(i)"> <text>Law enforcement agency;</text> </paragraph> <paragraph num="(ii)"> <text>Prosecutor;</text> </paragraph> <paragraph num="(iii)"> <text>Criminal suspect, defendant, or defendant’s legal representative; or</text> </paragraph> <paragraph num="(iv)"> <text>Court.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Forensic analysis” does not include:</text> <paragraph num="(i)"> <text>A test of a specimen of breath or blood to determine alcohol concentration or controlled dangerous substance content;</text> </paragraph> <paragraph num="(ii)"> <text>Forensic information technology;</text> </paragraph> <paragraph num="(iii)"> <text>A presumptive test performed at a crime scene;</text> </paragraph> <paragraph num="(iv)"> <text>A presumptive test performed for the purpose of determining compliance with a term or condition of community supervision or parole and conducted by or under contract with a county department of corrections or the Department of Public Safety and Correctional Services; or</text> </paragraph> <paragraph num="(v)"> <text>An expert examination or test conducted principally for the purpose of scientific research, medical practice, civil or administrative litigation, or any purpose other than determining the connection of physical evidence to a criminal act.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Forensic information technology” means digital or electronic evidence that is stored or transmitted electronically.</text> </paragraph> <paragraph num="(46)"> <text>Forensic Laboratory.</text> <paragraph num="(a)"> <text>“Forensic laboratory” means a facility, entity, or site that performs or offers to perform a forensic analysis.</text> </paragraph> <paragraph num="(b)"> <text>“Forensic laboratory” includes a laboratory owned or operated by the State, a county or municipal corporation in the State, or another governmental entity.</text> </paragraph> <paragraph num="(c)"> <text>“Forensic laboratory” does not include:</text> <paragraph num="(i)"> <text>A forensic laboratory operated by the federal government; or</text> </paragraph> <paragraph num="(ii)"> <text>A laboratory licensed or certified by the Maryland Department of Agriculture.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(47)"> <text>Incident Report.</text> <paragraph num="(a)"> <text>“Incident report” means a record used by a forensic laboratory to document procedural or policy noncompliance or unexpected outcomes.</text> </paragraph> <paragraph num="(b)"> <text>“Incident report” includes:</text> <paragraph num="(i)"> <text>Identification of the procedural or policy noncompliance or unexpected outcome;</text> </paragraph> <paragraph num="(ii)"> <text>Elimination steps taken, when applicable; and</text> </paragraph> <paragraph num="(iii)"> <text>Related documentation such as discrepancy logs and contamination records, when applicable.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(48)"> <text>“Internal audit” means a licensee’s self-inspection, based on standards defined by the laboratory’s director and quality assurance manager, to evaluate, confirm, or verify the forensic laboratory’s activities related to quality control.</text> </paragraph> <paragraph num="(49)"> <text>“Internal proficiency tests” means samples or specimens developed by the laboratory director or the director’s designee and administered to an analyst or examiner for analysis or examination as unknown samples or specimens.</text> </paragraph> <paragraph num="(50)"> <text>“Internal validation” means the in-house demonstration of the accuracy, reliability, and limitations of a technical procedure or analysis.</text> </paragraph> <paragraph num="(51)"> <text>“Laboratory designed tests” means test procedures developed and subjected to validation within the forensic laboratory.</text> </paragraph> <paragraph num="(52)"> <text>“Laboratory director” means an individual who:</text> <paragraph num="(a)"> <text>Meets the education and experience requirements set forth in this subtitle for a laboratory director; and</text> </paragraph> <paragraph num="(b)"> <text>Participates in and actively oversees the planning, direction, organization, and review of all forensic laboratory operations to the extent necessary to ensure compliance with this subtitle.</text> </paragraph> </paragraph> <paragraph num="(53)"> <text>“Laboratory system” is an organization having at least two physically separate forensic laboratory facilities that are independently managed under the direction of a single individual in the chain of command.</text> </paragraph> <paragraph num="(54)"> <text>“Letter of permit exception” means a letter granting limited authority to an individual not associated with a public or commercial laboratory, who reviews results or conclusions of the original forensic analysis performed by a licensed forensic laboratory solely for the purpose of assessing the original opinion, interpretation, or conclusion of the licensed forensic laboratory.</text> </paragraph> <paragraph num="(55)"> <text>“License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to a forensic laboratory to perform or offer to perform forensic analyses in the State.</text> </paragraph> <paragraph num="(56)"> <text>“Licensed forensic laboratory” means a forensic laboratory operating under a license issued by the Department.</text> </paragraph> <paragraph num="(57)"> <text>“Licensee” means a person who holds a license under this subtitle to maintain and operate a forensic laboratory.</text> </paragraph> <paragraph num="(58)"> <text>“Limited access” means employees are restricted from accessing or entering a specific area of the laboratory unless authorized by the laboratory director.</text> </paragraph> <paragraph num="(59)"> <text>“Limited forensic analysis” means performing a forensic laboratory test or analysis in a single discipline or subdiscipline.</text> </paragraph> <paragraph num="(60)"> <text>“Office of Health Care Quality” means the Office of Health Care Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(61)"> <text>“Owner” means a person who possesses a financial interest in a forensic laboratory.</text> </paragraph> <paragraph num="(62)"> <text>“Performance check” means an evaluation of a test system by assessing the functionality of system components in total, including but not limited to, assessment of the test system’s:</text> <paragraph num="(a)"> <text>Accuracy;</text> </paragraph> <paragraph num="(b)"> <text>Precision; and</text> </paragraph> <paragraph num="(c)"> <text>Reagents.</text> </paragraph> </paragraph> <paragraph num="(63)"> <text>“Permitted forensic laboratory” means a licensed forensic laboratory operating under a permit issued by the Department.</text> </paragraph> <paragraph num="(64)"> <text>“Physical evidence” means any object, thing, or substance relating to a criminal act.</text> </paragraph> <paragraph num="(65)"> <text>“Plan of correction” means a post-audit report created by a forensic laboratory in response to a deficiency statement received from:</text> <paragraph num="(a)"> <text>The forensic laboratory’s accrediting organization; or</text> </paragraph> <paragraph num="(b)"> <text>The Department.</text> </paragraph> </paragraph> <paragraph num="(66)"> <text>“Policy” means a written document that outlines a principle, plan, or course of action in regard to the operation of a forensic laboratory, including but not limited to:</text> <paragraph num="(a)"> <text>Quality assurance;</text> </paragraph> <paragraph num="(b)"> <text>Data integrity and ethics;</text> </paragraph> <paragraph num="(c)"> <text>Quality control;</text> </paragraph> <paragraph num="(d)"> <text>Safety; and</text> </paragraph> <paragraph num="(e)"> <text>Training.</text> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Precision” means the agreement of results among themselves when a specimen or sample is tested multiple times.</text> </paragraph> <paragraph num="(68)"> <text>“Presumptive test” means a test that does not provide a conclusive result, but is used to screen for the presence of a substance.</text> </paragraph> <paragraph num="(69)"> <text>“Principal sanction” means the denial, suspension, or revocation of a license.</text> </paragraph> <paragraph num="(70)"> <text>“Procedure” means a way of doing something that is set down in a written or electronic document that details the sequence of actions or step-by-step instructions to be followed to accomplish an administrative or technical task.</text> </paragraph> <paragraph num="(71)"> <text>“Proficiency testing” means determining the ability of an individual or a forensic laboratory to perform a forensic analysis to obtain a correct test result by:</text> <paragraph num="(a)"> <text>Performing a forensic analysis on a sample provided by a proficiency testing provider or laboratory director; and</text> </paragraph> <paragraph num="(b)"> <text>Reporting the results of the forensic analysis to the proficiency testing provider or laboratory director for evaluation.</text> </paragraph> </paragraph> <paragraph num="(72)"> <text>“Proficiency testing provider” means an entity external to the participating forensic laboratory that:</text> <paragraph num="(a)"> <text>Has one or more samples with values initially known only by the proficiency testing provider;</text> </paragraph> <paragraph num="(b)"> <text>Sends one or more samples to a participating forensic laboratory to perform forensic analyses; and</text> </paragraph> <paragraph num="(c)"> <text>Reports the results to the provider.</text> </paragraph> </paragraph> <paragraph num="(73)"> <text>“Qualitative” means relating to or involving comparisons based on the attributes or qualities of an item or thing.</text> </paragraph> <paragraph num="(74)"> <text>“Quality assurance” means a system of established policies and procedures designed to monitor, review, evaluate, and improve the ongoing and overall quality aspects of the forensic laboratory.</text> </paragraph> <paragraph num="(75)"> <text>“Quality assurance manager” means an individual designated by a director who is responsible for ensuring the requirements for a forensic laboratory’s quality assurance program are:</text> <paragraph num="(a)"> <text>Established;</text> </paragraph> <paragraph num="(b)"> <text>Implemented;</text> </paragraph> <paragraph num="(c)"> <text>Followed; and</text> </paragraph> <paragraph num="(d)"> <text>Maintained.</text> </paragraph> </paragraph> <paragraph num="(76)"> <text>Quality Control.</text> <paragraph num="(a)"> <text>“Quality control” means the established policies and procedures designed and used to ensure the quality of results obtained from the analytic phase of a testing process.</text> </paragraph> <paragraph num="(b)"> <text>“Quality control” includes, but is not limited to, activities that detect, monitor, review, and evaluate the:</text> <paragraph num="(i)"> <text>Accuracy, reliability, and precision of the analytic phase of a testing process;</text> </paragraph> <paragraph num="(ii)"> <text>Changes in the chemical, electronic, optical, or mechanical components of a test system;</text> </paragraph> <paragraph num="(iii)"> <text>Deterioration of reagents, materials, or supplies used in a testing process; and</text> </paragraph> <paragraph num="(iv)"> <text>Employee practices during the testing process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(77)"> <text>“Quality control testing” means analyses or examinations performed on quality control samples as part of the laboratory’s quality assurance program to demonstrate that a forensic analysis:</text> <paragraph num="(a)"> <text>Is performed correctly; and</text> </paragraph> <paragraph num="(b)"> <text>The test system is working properly to obtain a known result.</text> </paragraph> </paragraph> <paragraph num="(78)"> <text>“Quantitative” means expressible as a quantity or relating to measurement or a determination of the amounts and proportions of the chemical constituents of a substance or mixture.</text> </paragraph> <paragraph num="(79)"> <text>“Reagent” means a substance or mixture of substances used in a chemical or biological test to detect, measure, or examine physical evidence or produce other substances.</text> </paragraph> <paragraph num="(80)"> <text>“Records” means both examination and administrative documents.</text> </paragraph> <paragraph num="(81)"> <text>“Reference standard” means a material or sample with known properties that is acquired or prepared to:</text> <paragraph num="(a)"> <text>Calibrate analytical equipment; or</text> </paragraph> <paragraph num="(b)"> <text>Use as an external quality control.</text> </paragraph> </paragraph> <paragraph num="(82)"> <text>“Reliability” means the consistency of a measurement, that is, the degree to which an instrument or test system measures the same way each time it is used under the same set of conditions.</text> </paragraph> <paragraph num="(83)"> <text>“Reproducibility” means the ability of a test method or test system to produce consistent results if replicated by analysts or examiners working independent of one another.</text> </paragraph> <paragraph num="(84)"> <text>“Safeguard” means a person, procedure, or mechanism that protects and ensures the integrity of:</text> <paragraph num="(a)"> <text>Evidence;</text> </paragraph> <paragraph num="(b)"> <text>Test methods and test systems;</text> </paragraph> <paragraph num="(c)"> <text>Examinations; and</text> </paragraph> <paragraph num="(d)"> <text>Documents.</text> </paragraph> </paragraph> <paragraph num="(85)"> <text>“Safety program” means the policies and procedures that describe the various elements of a forensic laboratory’s safety system.</text> </paragraph> <paragraph num="(86)"> <text>Sanction.</text> <paragraph num="(a)"> <text>“Sanction” means an adverse action against a forensic laboratory that the Secretary may impose to effect statutory or regulatory compliance.</text> </paragraph> <paragraph num="(b)"> <text>“Sanction” includes both principal and alternative sanctions.</text> </paragraph> </paragraph> <paragraph num="(87)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee, including the Department.</text> </paragraph> <paragraph num="(88)"> <text>“Security” means the policies and procedures implemented and followed by a licensee to ensure the protection, integrity, and prevention of contamination of the forensic evidence, data, and case records.</text> </paragraph> <paragraph num="(89)"> <text>“SOPM” means a standard operating procedures manual.</text> </paragraph> <paragraph num="(90)"> <text>“Standard” means one or more specific technical, procedural, fiscal, or other regulatory requirements that a forensic laboratory or individual shall meet to comply with this subtitle.</text> </paragraph> <paragraph num="(91)"> <text>“Subcontractor” means a person contracted by a licensee to perform a specific forensic analysis or other task related to the operation of the forensic laboratory.</text> </paragraph> <paragraph num="(92)"> <text>“Subdiscipline” means a specific type of analysis or analyses within a discipline of forensic science as set forth in this regulation.</text> </paragraph> <paragraph num="(93)"> <text>“Technical leader” means an individual who is qualified by education and experience and is accountable for the technical operations of the forensic laboratory analyses in a specific discipline or subdiscipline of forensic science.</text> </paragraph> <paragraph num="(94)"> <text>“Technical procedure” means a set of directions or step-by-step instructions for performing a forensic analysis or examination.</text> </paragraph> <paragraph num="(95)"> <text>“Technical review” means an evaluation of reports, notes, data, and other documents to ensure there is an appropriate and sufficient basis for the reported scientific conclusions.</text> </paragraph> <paragraph num="(96)"> <text>“Technical reviewer” means an employee or other individual who performs a technical review of a report and is:</text> <paragraph num="(a)"> <text>A current or previously qualified analyst in the discipline, subdiscipline, or method being reviewed; and</text> </paragraph> <paragraph num="(b)"> <text>Not an author or co-author of the report being reviewed.</text> </paragraph> </paragraph> <paragraph num="(97)"> <text>“Technician” means an individual who performs analytical techniques on evidence samples under the supervision of a qualified forensic analyst or examiner and who does not issue a report for the work performed.</text> </paragraph> <paragraph num="(98)"> <text>“Traceable” or “traceability” means the property of a measurement result by which the measurement can be related to appropriate standards through an unbroken chain of comparisons.</text> </paragraph> <paragraph num="(99)"> <text>Validation.</text> <paragraph num="(a)"> <text>“Validation” means a process by which a forensic analysis method or procedure is evaluated to determine the accuracy, reliability, and limitations of the test method or procedure for forensic casework.</text> </paragraph> <paragraph num="(b)"> <text>“Validation” applies to both new and modified existing forensic analysis methods and procedures and includes:</text> <paragraph num="(i)"> <text>Developmental validation, which is the review of acquired test data and determination of conditions and limitations of a new or novel method or procedure for use on forensic samples; and</text> </paragraph> <paragraph num="(ii)"> <text>Internal validation, which is a review of accumulated test data within the laboratory to demonstrate that an established method or procedure performs as expected in the laboratory and to specify laboratory interpretation guidelines.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(100)"> <text>“Verification” means a documented check of a comparison made between known and questioned specimens or samples by a second qualified forensic examiner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Incorporation by Reference."> <text>In this subtitle, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>42 U.S.C. §14131, as amended; and</text> </paragraph> <paragraph num="B."> <text>Quality Assurance Standards for DNA Testing Laboratories, September 2011, Federal Bureau of Investigation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> </annotations> </chapter> <chapter num="02" heading="Responsibilities, Accreditations, and Audits"> <regulation prefix="Regulation" num=".01" heading="Responsibilities of the Department."> <paragraph num="A."> <text>The Department shall conduct audits, as set forth in this chapter, of forensic laboratories that obtain or retain a license.</text> </paragraph> <paragraph num="B."> <text>Audits. The Department shall:</text> <paragraph num="(1)"> <text>Conduct or oversee an announced or unannounced audit of a forensic laboratory, at any time during a forensic laboratory’s hours of operation, to assess compliance with applicable sections of Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, and this subtitle; and</text> </paragraph> <paragraph num="(2)"> <text>Examine, as part of an audit, a forensic laboratory’s facilities, equipment, quality assurance records and procedures, operating procedures, employees, employee records, proficiency testing, results and reports of forensic analyses, and other records and files pertinent and subject to this subtitle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Issuance of Licensing Documents. The Department shall:</text> <paragraph num="(1)"> <text>License a person to operate a forensic laboratory by issuing a license when the forensic laboratory is in compliance with the applicable standards set forth in this subtitle; and</text> </paragraph> <paragraph num="(2)"> <text>Issue a license that includes the:</text> <paragraph num="(a)"> <text>Name of the forensic laboratory;</text> </paragraph> <paragraph num="(b)"> <text>Name of the licensee or owner;</text> </paragraph> <paragraph num="(c)"> <text>Name of the forensic laboratory director;</text> </paragraph> <paragraph num="(d)"> <text>Expiration date of the license; and</text> </paragraph> <paragraph num="(e)"> <text>Forensic science disciplines and subdisciplines in which the forensic laboratory is authorized to perform forensic analyses.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Administration and Information Management. The Department shall:</text> <paragraph num="(1)"> <text>Maintain a list of licensed forensic laboratories;</text> </paragraph> <paragraph num="(2)"> <text>Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary;</text> </paragraph> <paragraph num="(3)"> <text>Monitor the proficiency testing performance of a forensic laboratory required to participate in proficiency testing;</text> </paragraph> <paragraph num="(4)"> <text>Impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a forensic laboratory under the appropriate provisions of this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Forensic Laboratory Advisory Committee.</text> <paragraph num="(1)"> <text>The Secretary shall provide staff for the Forensic Laboratory Advisory Committee established by the Governor pursuant to Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Forensic Laboratory Advisory Committee:</text> <paragraph num="(a)"> <text>Shall advise the Secretary on matters relating to forensic laboratories as set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>May make recommendations to the Secretary concerning the:</text> <paragraph num="(i)"> <text>Implementation of the requirements for forensic laboratories set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Regulations required by Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>Department’s oversight and licensing of forensic laboratories.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Accredited Forensic Laboratory and Accrediting Organization."> <paragraph num="A."> <text>Accredited Forensic Laboratory — Determination. The Secretary shall accept as meeting the audit requirements of this subtitle a forensic laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the Department determines that the standards of the forensic laboratory’s accreditation organization are equivalent to those under this subtitle.</text> </paragraph> <paragraph num="B."> <text>Accredited Forensic Laboratory — Requirements. In addition to meeting the requirements for obtaining and maintaining a certificate of accreditation, as set forth by the forensic laboratory’s accrediting organization, an accredited forensic laboratory shall:</text> <paragraph num="(1)"> <text>Obtain and maintain a valid license issued by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Be subject to audit by the Department as set forth in COMAR 10.51.02.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Accreditation Organization.</text> <paragraph num="(1)"> <text>A private, nonprofit forensic laboratory accreditation organization may inspect and accredit forensic laboratories in the State for the purpose of State licensure only after applying for and receiving approval of the Department, as the Secretary’s designee.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall base approval of a forensic laboratory accreditation organization on a review of information provided by that organization, including but not limited to:</text> <paragraph num="(a)"> <text>Data collection and data sharing and reporting policies;</text> </paragraph> <paragraph num="(b)"> <text>Accreditation policies, procedures, and standards;</text> </paragraph> <paragraph num="(c)"> <text>Assessment forms and guidelines;</text> </paragraph> <paragraph num="(d)"> <text>Assessment and deficiency writing policies and procedures;</text> </paragraph> <paragraph num="(e)"> <text>Assessor and technical expert qualifications;</text> </paragraph> <paragraph num="(f)"> <text>Complaint investigation policies and procedures;</text> </paragraph> <paragraph num="(g)"> <text>Proficiency test monitoring policies and procedures; and</text> </paragraph> <paragraph num="(h)"> <text>Procedures the accreditation organization will follow when notifying the Department that the accreditation organization:</text> <paragraph num="(i)"> <text>Is denying, withdrawing, suspending, revoking, or otherwise limiting a forensic laboratory’s accreditation;</text> </paragraph> <paragraph num="(ii)"> <text>Finds serious jeopardy to individual rights or identifies a hazard to public safety;</text> </paragraph> <paragraph num="(iii)"> <text>Accredits a new forensic laboratory;</text> </paragraph> <paragraph num="(iv)"> <text>Imposes an adverse or corrective action on a forensic laboratory; or</text> </paragraph> <paragraph num="(v)"> <text>Is initiating a complaint investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>In addition to requirements set forth elsewhere in this subtitle, an accreditation organization shall:</text> <paragraph num="(a)"> <text>Provide to the Department:</text> <paragraph num="(i)"> <text>Annually, an updated list containing the names, addresses, and accreditation expiration dates of forensic laboratories in the State that are accredited by the organization;</text> </paragraph> <paragraph num="(ii)"> <text>Within 30 days after conducting an assessment, a certified written or electronic copy of each assessment report covering each forensic laboratory applying for or maintaining accreditation in the State;</text> </paragraph> <paragraph num="(iii)"> <text>Written notice of any proposed change to requirements for forensic laboratory accreditation, at least 30 days before the effective date of the change;</text> </paragraph> <paragraph num="(iv)"> <text>Within 10 days after a forensic laboratory’s certificate of accreditation expires, written or electronic notice when the forensic laboratory does not renew an accreditation certificate; and</text> </paragraph> <paragraph num="(v)"> <text>Within 24 hours after taking an action, telephonic or electronic notice when an accredited forensic laboratory’s certificate of accreditation is suspended, revoked, surrendered, or otherwise limited;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evaluate compliance, when applicable, with State regulations pertaining to:</text> <paragraph num="(i)"> <text>Forensic analyses;</text> </paragraph> <paragraph num="(ii)"> <text>Reporting of forensic analysis results as required by law or regulation; and</text> </paragraph> <paragraph num="(iii)"> <text>Proficiency testing;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Evaluate compliance with State regulations by:</text> <paragraph num="(i)"> <text>Incorporating an evaluation of compliance with State regulatory requirements into the accreditation organization’s own assessment process; or</text> </paragraph> <paragraph num="(ii)"> <text>Demonstrating that the accreditation organization’s existing assessment process adequately evaluates compliance with State regulations; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>On request, provide to the Department a copy of:</text> <paragraph num="(i)"> <text>A complaint investigation;</text> </paragraph> <paragraph num="(ii)"> <text>Assessor qualifications;</text> </paragraph> <paragraph num="(iii)"> <text>A change in a forensic laboratory’s forensic disciplines or subdisciplines; or</text> </paragraph> <paragraph num="(iv)"> <text>Other information the Department may require relating to approval of a forensic laboratory accreditation organization.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Audits."> <paragraph num="A."> <text>General.</text> <paragraph num="(1)"> <text>A licensee shall allow an on-site audit by the Department and, when applicable, by the forensic laboratory’s accreditation organization, at any time during the forensic laboratory’s normal hours of operation, to evaluate the forensic laboratory’s compliance with the applicable requirements, conditions, and standards of this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>An audit may include but is not limited to observation and examination of:</text> <paragraph num="(a)"> <text>Laboratory facilities;</text> </paragraph> <paragraph num="(b)"> <text>Equipment;</text> </paragraph> <paragraph num="(c)"> <text>Quality assurance and quality control program records;</text> </paragraph> <paragraph num="(d)"> <text>Operating procedures;</text> </paragraph> <paragraph num="(e)"> <text>Employees;</text> </paragraph> <paragraph num="(f)"> <text>Employee records;</text> </paragraph> <paragraph num="(g)"> <text>Proficiency testing;</text> </paragraph> <paragraph num="(h)"> <text>Forensic analysis reports; and</text> </paragraph> <paragraph num="(i)"> <text>Other records and files pertinent to this subtitle.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Forensic laboratory employees shall make data and records accessible during an on-site audit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Permitted Forensic Laboratory. A licensee operating a forensic laboratory under a permit shall:</text> <paragraph num="(1)"> <text>Be subject to routine audits conducted by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Undergo a routine audit within 6 months after the forensic laboratory:</text> <paragraph num="(a)"> <text>Begins operating;</text> </paragraph> <paragraph num="(b)"> <text>Undergoes a change in ownership; or</text> </paragraph> <paragraph num="(c)"> <text>Has had a principal or alternative sanction imposed; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Undergo a routine triennial audit after meeting the audit requirements set forth in §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Accredited Forensic Laboratory. An accredited forensic laboratory is:</text> <paragraph num="(1)"> <text>Not subject to routine audits conducted by the Department as set forth in §B of this regulation if the accredited forensic laboratory is undergoing routine on-site assessment conducted by an accreditation organization approved by the Secretary, except as provided in §C(2) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to audits conducted by the Department to:</text> <paragraph num="(a)"> <text>Investigate a complaint;</text> </paragraph> <paragraph num="(b)"> <text>Determine regulatory compliance with any quality requirement;</text> </paragraph> <paragraph num="(c)"> <text>Follow up on any serious problem identified by an accreditation organization; or</text> </paragraph> <paragraph num="(d)"> <text>Validate an accreditation organization’s assessment of a forensic laboratory.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Public Record.</text> <paragraph num="(1)"> <text>A forensic laboratory shall make discrepancy logs, contamination records, test results, and final inspection reports, including deficiency statements and plans of correction, available to the public within 30 business days of a written request for these public documents.</text> </paragraph> <paragraph num="(2)"> <text>Except as identified in this section or as otherwise provided by law, the proceedings, records, and files of an organization or State agency responsible for assuring compliance with this subtitle shall be confidential and may not be discoverable or admissible as evidence in a civil or criminal action.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Internal Audits.</text> <paragraph num="(1)"> <text>A forensic laboratory shall conduct and document an annual audit of the overall operations of the forensic laboratory and generate a written audit report that identifies the finding and the corrective action taken to address the noncompliance.</text> </paragraph> <paragraph num="(2)"> <text>The forensic laboratory shall:</text> <paragraph num="(a)"> <text>Report the audit documentation to the Department within 4 months of the audit date;</text> </paragraph> <paragraph num="(b)"> <text>Make the audit documentation available on-site for inspection by the Department or its designee;</text> </paragraph> <paragraph num="(c)"> <text>Conduct an audit in each discipline in which the laboratory performs forensic analyses, using the quality assurance program policies, procedures, and protocols currently in use during the auditing cycle; and</text> </paragraph> <paragraph num="(d)"> <text>Conduct a comprehensive evaluation of the overall quality assurance program that includes both administrative and technical services.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="03" heading="Licenses"> <regulation prefix="Regulation" num=".01" heading="License — General."> <paragraph num="A."> <text>General Requirements.</text> <paragraph num="(1)"> <text>A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State.</text> </paragraph> <paragraph num="(2)"> <text>A person may not perform or offer to perform forensic analysis without first obtaining a forensic laboratory license from the Secretary.</text> </paragraph> <paragraph num="(3)"> <text>Letter of Permit Exception.</text> <paragraph num="(a)"> <text>The Secretary may grant an individual a letter of permit exception if:</text> <paragraph num="(i)"> <text>The individual is not affiliated with a public or commercial laboratory that performs forensic analyses;</text> </paragraph> <paragraph num="(ii)"> <text>The application for the letter of permit exception is limited to an individual performing limited forensic analysis in a discipline or subdiscipline; and</text> </paragraph> <paragraph num="(iii)"> <text>The individual applying for the letter of permit exception has documentation that demonstrates the individual’s competency and experience in the specific forensic discipline or subdiscipline in which the forensic analysis will be performed.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The individual who will perform the forensic analysis shall:</text> <paragraph num="(i)"> <text>Submit an application for a letter of permit exception to the Department for approval;</text> </paragraph> <paragraph num="(ii)"> <text>Renew a letter of permit exception every 3 years from the date of issuance, if renewal is desired;</text> </paragraph> <paragraph num="(iii)"> <text>Be subject to oversight by the Department; and</text> </paragraph> <paragraph num="(iv)"> <text>Be subject to the sanctions set forth in COMAR 10.51.07.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Waiver.</text> <paragraph num="(a)"> <text>The Secretary may grant to a forensic laboratory not located in this State, a waiver from the licensing requirements of this subtitle if:</text> <paragraph num="(i)"> <text>The forensic analysis or examination is not performed by a licensee;</text> </paragraph> <paragraph num="(ii)"> <text>The waiver is limited to a single case or related cases; and</text> </paragraph> <paragraph num="(iii)"> <text>The person requesting the waiver has documentation that demonstrates the forensic laboratory’s competency and quality.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A licensee, a party to a criminal case or related cases, or the forensic laboratory that has been requested to perform a forensic analysis shall:</text> <paragraph num="(i)"> <text>Submit a request for a waiver for approval by the Department; and</text> </paragraph> <paragraph num="(ii)"> <text>Make requests in accordance with the process established by the Department.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Department may require an out-of-State laboratory that has been waived for licensure to apply for licensure based on the number of waivers issued to that laboratory by the Department.</text> </paragraph> <paragraph num="(d)"> <text>The Department may deny a waiver if:</text> <paragraph num="(i)"> <text>The Department determines the laboratory has been the subject of frequent waiver requests and the laboratory has failed to apply for licensure; or</text> </paragraph> <paragraph num="(ii)"> <text>The laboratory’s license application was denied or its license was suspended or revoked by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Prohibited Analyses. The Secretary may impose principal and alternative sanctions as set forth in this subtitle if a person performs or offers to perform a forensic analysis or part of a forensic analysis, including the use of a reagent, supply, procedure, method, technique, kit, or equipment, that:</text> <paragraph num="(a)"> <text>Does not produce accurate or reliable forensic analysis results as evidenced by documented, independent scientific testing and evaluation; or</text> </paragraph> <paragraph num="(b)"> <text>Lacks proof of efficacy substantiated by independently conducted and documented scientifically based evidence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Limitation. A person may not operate a forensic laboratory in a forensic science discipline or subdiscipline other than what is listed on the license unless it is a discipline or subdiscipline listed under COMAR 10.51.01.02C .</text> </paragraph> <paragraph num="C."> <text>Application Eligibility. A person meeting the requirements and standards of this subtitle and the requirements set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, may apply for a forensic laboratory permit.</text> </paragraph> <paragraph num="D."> <text>Issuance.</text> <paragraph num="(1)"> <text>Permit. The Secretary may issue a permit that:</text> <paragraph num="(a)"> <text>Is valid for not more than 3 years from the date of issue; and</text> </paragraph> <paragraph num="(b)"> <text>Shall be renewed before the date of expiration if a person intends to operate the forensic laboratory in the succeeding permit period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Site License Required. A person shall obtain a separate license for each location at which the person maintains a site to perform forensic analyses.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="License — Requirements."> <paragraph num="A."> <text>Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall:</text> <paragraph num="(1)"> <text>Obtain, complete, and submit written or electronic permit applications as prescribed in this subtitle;</text> </paragraph> <paragraph num="(2)"> <text>Obtain a forensic laboratory license as required in this subtitle; and</text> </paragraph> <paragraph num="(3)"> <text>Renew a forensic laboratory license as required in this subtitle.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Regulatory Requirements. A person operating a forensic laboratory under a license shall comply with the:</text> <paragraph num="(1)"> <text>Audit requirements set forth in COMAR 10.51.02.03;</text> </paragraph> <paragraph num="(2)"> <text>Applicable proficiency testing requirements set forth in COMAR 10.51.04;</text> </paragraph> <paragraph num="(3)"> <text>Applicable ethics, data integrity, and non-retaliation requirements set forth in COMAR 10.51.05.16 and .17;</text> </paragraph> <paragraph num="(4)"> <text>Applicable quality systems, quality assurance, and quality control requirements set forth in COMAR 10.51.05;</text> </paragraph> <paragraph num="(5)"> <text>Applicable employee requirements set forth in COMAR 10.51.06; and</text> </paragraph> <paragraph num="(6)"> <text>Applicable federal, State, and local requirements regarding the operation of forensic laboratories.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License — Administrative Procedures."> <paragraph num="A."> <text>Application — Filing.</text> <paragraph num="(1)"> <text>A person shall:</text> <paragraph num="(a)"> <text>Apply for a license for each forensic laboratory location;</text> </paragraph> <paragraph num="(b)"> <text>File an application for a license using written or electronic forms provided by the Department; and</text> </paragraph> <paragraph num="(c)"> <text>Include in the application a description of forensic laboratory services, which includes but is not limited to:</text> <paragraph num="(i)"> <text>Types of forensic analyses performed or to be performed;</text> </paragraph> <paragraph num="(ii)"> <text>Total number of individuals who perform forensic analyses for each forensic science discipline; and</text> </paragraph> <paragraph num="(iii)"> <text>Qualifications of employees who direct, supervise, and perform forensic analyses.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The forensic laboratory director shall sign the application forms attesting that the:</text> <paragraph num="(a)"> <text>Information provided in the application is accurate; and</text> </paragraph> <paragraph num="(b)"> <text>Forensic laboratory is or will be operated in accordance with the requirements and standards set forth in this subtitle.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Application — Evaluation and Billing. The Department shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the:</text> <paragraph num="(1)"> <text>Application is complete; and</text> </paragraph> <paragraph num="(2)"> <text>Forensic laboratory is eligible for a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Application — Denial of License. If the Department determines that a forensic laboratory is not in compliance with the requirements of this subtitle and therefore cannot be issued a license, the Department shall provide to the forensic laboratory:</text> <paragraph num="(1)"> <text>A written statement of the grounds on which the denial is based; and</text> </paragraph> <paragraph num="(2)"> <text>The opportunity to:</text> <paragraph num="(a)"> <text>Amend and resubmit the application; or</text> </paragraph> <paragraph num="(b)"> <text>Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201 — 10-226, and Health-General Article, §17-2A-09, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notification Requirements. A licensee shall notify the Department within 30 days of a change in forensic laboratory:</text> <paragraph num="(1)"> <text>Ownership;</text> </paragraph> <paragraph num="(2)"> <text>Name;</text> </paragraph> <paragraph num="(3)"> <text>Location; or</text> </paragraph> <paragraph num="(4)"> <text>Director.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Amending a License. Except as prescribed in §D of this regulation, a licensee holding an unexpired license who wishes to have a permit amended shall:</text> <paragraph num="(1)"> <text>Submit a written request to amend the license to the Department;</text> </paragraph> <paragraph num="(2)"> <text>Remit to the Department a $50 relicensing fee; and</text> </paragraph> <paragraph num="(3)"> <text>Obtain written approval from the Department before implementing the change to the forensic laboratory’s operation or forensic analysis that is affected by the amendment.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Expiration and Renewal.</text> <paragraph num="(1)"> <text>A license expires on the date shown on the license.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall provide a renewal application to a forensic laboratory not less than 30 days before the expiration date shown on the license.</text> </paragraph> <paragraph num="(3)"> <text>In order to renew a license, a licensee shall file an application to renew the license using written or electronic forms provided by the Department and following the same procedures prescribed in §§A and B of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>A licensee who fails to submit a completed renewal application before the expiration date may not operate the forensic laboratory after the permit expiration date.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Non-Transferability. A license is not transferable.</text> </paragraph> <paragraph num="H."> <text>Addition of a New Discipline, Subdiscipline, or Forensic Analysis.</text> <paragraph num="(1)"> <text>A licensee shall:</text> <paragraph num="(a)"> <text>Apply for a provisional license for each new discipline, subdiscipline, or forensic analysis the licensee wishes to perform;</text> </paragraph> <paragraph num="(b)"> <text>File an application for a provisional license using forms provided by the Department;</text> </paragraph> <paragraph num="(c)"> <text>Include in the application a description of each new discipline, subdiscipline, or forensic analysis; and</text> </paragraph> <paragraph num="(d)"> <text>Make payment of any fees associated with each new addition.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee shall provide documentation of:</text> <paragraph num="(a)"> <text>Validation for the new discipline, subdiscipline, or forensic analysis; and</text> </paragraph> <paragraph num="(b)"> <text>Completion of training to include competency tests, and if applicable, proficiency tests of individuals who perform analyses within each new discipline, subdiscipline, or forensic analysis.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An accredited licensee shall be subject to review by the Department until the new discipline, subdiscipline, or forensic analysis is accredited.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Licenses and Fees renamed Licenses effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 29, 2016 (43:17 Md. R. 953)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, F amended effective March 13, 2017 (44:5 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed effective August 29, 2016 (43:17 Md. R. 953)</annotation> </annotations> </chapter> <chapter num="04" heading="Proficiency Testing"> <regulation prefix="Regulation" num=".01" heading="Proficiency Testing — General."> <paragraph num="A."> <text>Proficiency Testing. Each year a licensee shall participate in an external proficiency testing program for each forensic science discipline in which the laboratory performs forensic tests and examinations, including but not limited to:</text> <paragraph num="(1)"> <text>Firearms and toolmarks;</text> </paragraph> <paragraph num="(2)"> <text>Questioned documents;</text> </paragraph> <paragraph num="(3)"> <text>Latent prints;</text> </paragraph> <paragraph num="(4)"> <text>Trace evidence;</text> </paragraph> <paragraph num="(5)"> <text>Biology;</text> </paragraph> <paragraph num="(6)"> <text>Controlled dangerous substances; and</text> </paragraph> <paragraph num="(7)"> <text>Toxicology.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Proficiency Testing Performance and Participation Requirements.</text> <paragraph num="(1)"> <text>Annually, a forensic analyst shall:</text> <paragraph num="(a)"> <text>Participate in a proficiency test for each discipline for which the forensic analyst is qualified to perform tests or examinations for casework; and</text> </paragraph> <paragraph num="(b)"> <text>Perform the proficiency testing analysis using the same methods and procedures routinely used for performing the forensic analysis of casework.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For each subdiscipline for which a forensic analyst performs casework, the forensic analyst shall perform proficiency testing at least once in the 3-year license period or if applicable within the required time period outlined by the accreditation organization.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Proficiency Testing Performance, Participation Schedule, and Documentation. The quality assurance manager or technical leader, as designated by the director, shall:</text> <paragraph num="(1)"> <text>Establish a formal, written proficiency testing protocol covering both external and internal proficiency tests for each forensic science discipline and subdiscipline in which the laboratory performs tests and examinations; and</text> </paragraph> <paragraph num="(2)"> <text>Document and maintain all records of proficiency testing and results for each individual forensic analyst required to participate in proficiency testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Proficiency Testing — Forensic DNA Analysis."> <text>Regardless of whether the individual provides results or conclusions, an individual who provides technical support for DNA analysis, performs DNA analysis, or is designated by the technical leader as a participant in DNA casework, shall meet the proficiency testing requirements set forth in 42 U.S.C. §14131, which is incorporated by reference.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Proficiency Testing Provider Approval."> <paragraph num="A."> <text>Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a proficiency test in this State for use by a forensic laboratory without first obtaining proficiency testing approval from the Department.</text> </paragraph> <paragraph num="B."> <text>Approval Granted by the Secretary. The Department may approve a proficiency testing provider for a forensic science discipline or subdiscipline, if the proficiency testing provider:</text> <paragraph num="(1)"> <text>Provides reliable, documented evidence to the Department that the proficiency test is technically and administratively able to meet the applicable requirements of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Submits directly to the Department evaluations of all proficiency test results from each laboratory that holds a Maryland forensic laboratory permit.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> </annotations> </chapter> <chapter num="05" heading="Quality Assurance"> <regulation prefix="Regulation" num=".01" heading="Quality Assurance — General."> <text>To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory:</text> <paragraph num="A."> <text>Establishes and follows policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total examination and forensic analysis process;</text> </paragraph> <paragraph num="B."> <text>Maintains a quality assurance program that:</text> <paragraph num="(1)"> <text>Continually evaluates the effectiveness of the laboratory’s policies and procedures;</text> </paragraph> <paragraph num="(2)"> <text>Routinely revises policies and procedures based on the results of ongoing evaluation;</text> </paragraph> <paragraph num="(3)"> <text>Identifies and corrects problems;</text> </paragraph> <paragraph num="(4)"> <text>Assures:</text> <paragraph num="(a)"> <text>Accurate, complete, and reliable reporting of results of examinations and analyses;</text> </paragraph> <paragraph num="(b)"> <text>Technical procedures are validated and are accepted practice in the forensic discipline; and</text> </paragraph> <paragraph num="(c)"> <text>Adequate and competent employees;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Requires documentation of all quality assurance and quality control activities; and</text> </paragraph> <paragraph num="(6)"> <text>Includes policies and procedures for:</text> <paragraph num="(a)"> <text>Handling and preservation of evidence;</text> </paragraph> <paragraph num="(b)"> <text>Calibration and maintenance of equipment;</text> </paragraph> <paragraph num="(c)"> <text>Handling, maintaining, and securing laboratory records including case records and reports;</text> </paragraph> <paragraph num="(d)"> <text>Evaluation and approval of employees;</text> </paragraph> <paragraph num="(e)"> <text>Laboratory security;</text> </paragraph> <paragraph num="(f)"> <text>Identifying and implementing corrective actions;</text> </paragraph> <paragraph num="(g)"> <text>Documenting and investigating complaints;</text> </paragraph> <paragraph num="(h)"> <text>The operation of individual characteristic databases, where appropriate; and</text> </paragraph> <paragraph num="(i)"> <text>Data integrity and ethics;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Develops and maintains:</text> <paragraph num="(1)"> <text>An organizational chart of all employees;</text> </paragraph> <paragraph num="(2)"> <text>Job requirements and a job description for each contractor; and</text> </paragraph> <paragraph num="(3)"> <text>Employee records that include, but are not limited to:</text> <paragraph num="(a)"> <text>Job requirements and a job description for each employee;</text> </paragraph> <paragraph num="(b)"> <text>Educational background and qualifications;</text> </paragraph> <paragraph num="(c)"> <text>Curriculum vitae;</text> </paragraph> <paragraph num="(d)"> <text>Court testimony evaluations and a record that the evaluations are reviewed with each examiner and analyst;</text> </paragraph> <paragraph num="(e)"> <text>Documentation of successful completion of a training program set forth by the laboratory, including competency testing;</text> </paragraph> <paragraph num="(f)"> <text>Authorization to perform independent casework; and</text> </paragraph> <paragraph num="(g)"> <text>Performance evaluations;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Establishes and maintains a forensic laboratory safety program;</text> </paragraph> <paragraph num="E."> <text>Employs appropriately trained employees and possesses equipment to conduct the scope of forensic services offered;</text> </paragraph> <paragraph num="F."> <text>Maintains reference literature in physical or electronic form that covers all disciplines and subdisciplines for which services are offered;</text> </paragraph> <paragraph num="G."> <text>Designates an individual as the quality assurance manager;</text> </paragraph> <paragraph num="H."> <text>Defines and maintains a document retention policy;</text> </paragraph> <paragraph num="I."> <text>Maintains a facility that is designed to ensure the integrity of the forensic analyses and the evidence;</text> </paragraph> <paragraph num="J."> <text>Conducts:</text> <paragraph num="(1)"> <text>Administrative review of all cases and reports before issuing a report; and</text> </paragraph> <paragraph num="(2)"> <text>Technical review, of no less than 5 percent of cases as determined by the laboratory director or designee, to ensure conclusions and supporting data are within the constraints of scientific knowledge; and</text> </paragraph> </paragraph> <paragraph num="K."> <text>Establishes a mechanism to address unresolved discrepant conclusions between an analyst and the technical reviewer.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Quality Assurance — Specific."> <paragraph num="A."> <text>Policies and Procedure.</text> <paragraph num="(1)"> <text>A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained.</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence.</text> </paragraph> <paragraph num="(3)"> <text>Chain of Custody. The licensee shall:</text> <paragraph num="(a)"> <text>Maintain a record of chain of custody in written or electronic form in order to maintain accurate tracking of all evidence; and</text> </paragraph> <paragraph num="(b)"> <text>Document each transfer of evidence with the date of transfer and the signature of the person receiving the evidence at the time of transfer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Identifying and Handling Evidence. A licensee shall:</text> <paragraph num="(1)"> <text>Ensure that each item of evidence received by the forensic laboratory:</text> <paragraph num="(a)"> <text>Is permanently marked and includes a unique identifier either on the:</text> <paragraph num="(i)"> <text>Evidence itself; or</text> </paragraph> <paragraph num="(ii)"> <text>Proximal container of the evidence; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has a documented record that includes the:</text> <paragraph num="(i)"> <text>Identity of the evidence submitter;</text> </paragraph> <paragraph num="(ii)"> <text>Date the item of evidence was submitted; and</text> </paragraph> <paragraph num="(iii)"> <text>Description of the item of evidence submitted;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Establish and follow a procedure to identify evidence that cannot be marked or identified as set forth in §B(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Ensure all items produced during a forensic analysis or examination are:</text> <paragraph num="(a)"> <text>Marked with a unique identifier that can be traced back to the original evidence;</text> </paragraph> <paragraph num="(b)"> <text>Appropriately packaged;</text> </paragraph> <paragraph num="(c)"> <text>Documented in case notes, reports, and the evidence tracking system; and</text> </paragraph> <paragraph num="(d)"> <text>Packed with the original evidence when applicable or a disposition will be noted;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ensure documentation of the date of receipt of each test item and evidence;</text> </paragraph> <paragraph num="(5)"> <text>Establish, maintain, and follow a procedure to define proper packaging and sealing of evidence requiring that:</text> <paragraph num="(a)"> <text>Evidentiary seals:</text> <paragraph num="(i)"> <text>Are initialed or marked by the person sealing the evidence; and</text> </paragraph> <paragraph num="(ii)"> <text>Prevent the evidence from being removed, lost, altered, or contaminated; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Evidence is protected from:</text> <paragraph num="(i)"> <text>Loss;</text> </paragraph> <paragraph num="(ii)"> <text>Cross-contamination; and</text> </paragraph> <paragraph num="(iii)"> <text>Any harmful change; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Consider evidence containers properly sealed only if:</text> <paragraph num="(a)"> <text>The contents cannot readily escape; and</text> </paragraph> <paragraph num="(b)"> <text>Entering the container results in obvious damage or alteration to the container or the container’s seal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Deficiencies, Errors, and Corrective Actions. A licensee shall have:</text> <paragraph num="(1)"> <text>A procedure for corrective actions to be taken when a deficiency or error is identified with:</text> <paragraph num="(a)"> <text>A forensic analysis procedure or method; or</text> </paragraph> <paragraph num="(b)"> <text>The casework or proficiency testing of a forensic analyst or examiner; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The procedure and required documentation for the corrective actions include:</text> <paragraph num="(a)"> <text>A determination of the cause of the deficiency or error;</text> </paragraph> <paragraph num="(b)"> <text>An evaluation of the deficiency or error to determine if the deficiency or error causes or has caused an adverse effect on the quality of a forensic analysis;</text> </paragraph> <paragraph num="(c)"> <text>An indication of the individual responsible for corrective action;</text> </paragraph> <paragraph num="(d)"> <text>A timeline of corrective action or actions; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the corrective action was:</text> <paragraph num="(i)"> <text>Implemented; and</text> </paragraph> <paragraph num="(ii)"> <text>Monitored for effectiveness in correcting the deficiency or error.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee shall designate a quality assurance manager to oversee and ensure that the quality assurance program is implemented, maintained, and routinely evaluated.</text> </paragraph> <paragraph num="E."> <text>A licensee shall ensure that a change to an entry on an examination document, whether written or electronic, is:</text> <paragraph num="(1)"> <text>Trackable to the person who made the change; and</text> </paragraph> <paragraph num="(2)"> <text>Not erased, hidden, obscured, disguised, or obliterated.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A licensee shall establish and follow a procedure to document any:</text> <paragraph num="(1)"> <text>Evidence discrepancies;</text> </paragraph> <paragraph num="(2)"> <text>Compromise of evidence integrity; or</text> </paragraph> <paragraph num="(3)"> <text>Lost or misplaced evidence.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A licensee shall document all quality assurance and quality control activities as set forth in this subtitle.</text> </paragraph> <paragraph num="H."> <text>A licensee shall establish a procedure to:</text> <paragraph num="(1)"> <text>Investigate, resolve, and document a forensic analysis discrepancy; and</text> </paragraph> <paragraph num="(2)"> <text>Allow for a request and approval from the director or designee for a deviation from standard operating procedures.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Public Record.</text> <paragraph num="(1)"> <text>A licensee shall establish and follow a procedure to make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request.</text> </paragraph> <paragraph num="(2)"> <text>A contamination record shall include the following information:</text> <paragraph num="(a)"> <text>Unique case identifier;</text> </paragraph> <paragraph num="(b)"> <text>Encoded sample identification;</text> </paragraph> <paragraph num="(c)"> <text>Description of results; and</text> </paragraph> <paragraph num="(d)"> <text>Identifiers that led to an incident report.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Quality Assurance — Specific for Postmortem Forensic Toxicology."> <paragraph num="A."> <text>In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a:</text> <paragraph num="(1)"> <text>Procedure for responding to requests for the laboratory’s information and documentation; and</text> </paragraph> <paragraph num="(2)"> <text>Policy for:</text> <paragraph num="(a)"> <text>Retention and release of laboratory information;</text> </paragraph> <paragraph num="(b)"> <text>Addressing the confidentiality of laboratory data; and</text> </paragraph> <paragraph num="(c)"> <text>Identifying:</text> <paragraph num="(i)"> <text>The extent to which interpretations may be provided with test results; and</text> </paragraph> <paragraph num="(ii)"> <text>Who is authorized to provide interpretations.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Specimen Collection and Handling.</text> <paragraph num="(1)"> <text>A laboratory director shall develop and provide, to all agencies or parties that submit or request postmortem toxicology analyses, instructions that include the specific requirements for the:</text> <paragraph num="(a)"> <text>Type and minimum amount of specimen needed to perform the:</text> <paragraph num="(i)"> <text>Requested analysis; and</text> </paragraph> <paragraph num="(ii)"> <text>Subsequent interpretations;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Type and size of specimen container;</text> </paragraph> <paragraph num="(c)"> <text>Type and amount of preservative to be added to biological fluids, when applicable;</text> </paragraph> <paragraph num="(d)"> <text>Labeling of each individual specimen container;</text> </paragraph> <paragraph num="(e)"> <text>Packaging and transport of a specimen;</text> </paragraph> <paragraph num="(f)"> <text>Submission of relevant medical history on decedents who may carry a highly infectious disease, such as tuberculosis, hepatitis, or human immunodeficiency virus (HIV);</text> </paragraph> <paragraph num="(g)"> <text>Labeling of each specimen as to type and source, if applicable; and</text> </paragraph> <paragraph num="(h)"> <text>Proper sealing of containers to prevent:</text> <paragraph num="(i)"> <text>Leakage of the specimen container; and</text> </paragraph> <paragraph num="(ii)"> <text>Cross-contamination between specimens.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee shall ensure that a specimen submitted for postmortem toxicology testing includes documentation that provides pertinent case information, including the:</text> <paragraph num="(a)"> <text>Name of decedent;</text> </paragraph> <paragraph num="(b)"> <text>Date of specimen collection; and</text> </paragraph> <paragraph num="(c)"> <text>Pertinent history of the case.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a specimen received for postmortem toxicology testing, a laboratory shall maintain a written or electronic record documenting the:</text> <paragraph num="(a)"> <text>Condition of the specimen;</text> </paragraph> <paragraph num="(b)"> <text>Handwritten initials or electronic signature of the individual who received the specimen;</text> </paragraph> <paragraph num="(c)"> <text>Date the specimen was received;</text> </paragraph> <paragraph num="(d)"> <text>Name of the decedent;</text> </paragraph> <paragraph num="(e)"> <text>Unique identifier assigned to the specimen;</text> </paragraph> <paragraph num="(f)"> <text>Specimen type;</text> </paragraph> <paragraph num="(g)"> <text>Date the specimen was collected; and</text> </paragraph> <paragraph num="(h)"> <text>Identification of the individual who collected the specimen.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensee shall develop and follow a policy for the retention, release, and disposal of specimens submitted for postmortem toxicology testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Quality Control Program."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Develop, establish, maintain, implement, and follow quality control policies and procedures that ensure accurate and reliable:</text> <paragraph num="(a)"> <text>Forensic analysis results; and</text> </paragraph> <paragraph num="(b)"> <text>Case reports;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ensure that all quality control activities set forth in this chapter are documented;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that the quality control program is able to detect shifts and trends that could result in an adverse impact on the quality of forensic analysis results;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that quality control data are evaluated routinely and when found to be contaminated, out of range, incorrect, or otherwise unacceptable:</text> <paragraph num="(a)"> <text>Corrective actions are taken; and</text> </paragraph> <paragraph num="(b)"> <text>Incorrect results are not reported;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Ensure that quality control material and reference standards are specified in the SOPM and the results of quality control testing are documented in the case record;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that a reagent used for a forensic analysis:</text> <paragraph num="(a)"> <text>Is tested for reliability before being put into use;</text> </paragraph> <paragraph num="(b)"> <text>Is identified with the:</text> <paragraph num="(i)"> <text>Name of the reagent;</text> </paragraph> <paragraph num="(ii)"> <text>Lot number or date the reagent was prepared; and</text> </paragraph> <paragraph num="(iii)"> <text>Expiration date;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is checked for reliability on a cycle determined by the technical leader;</text> </paragraph> <paragraph num="(d)"> <text>Has a record documenting:</text> <paragraph num="(i)"> <text>Who prepared the reagent; and</text> </paragraph> <paragraph num="(ii)"> <text>Completion of a reliability check before use; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Has storage, safety, and handling requirements specified;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Ensure that a reagent that is not used for a forensic analysis on a regular basis is tested for reliability before each use;</text> </paragraph> <paragraph num="(8)"> <text>Discard a reagent, make a new reagent, and check the new reagent’s reliability before any casework being performed, if the reagent reliability is found to be compromised;</text> </paragraph> <paragraph num="(9)"> <text>Use reagents that are suitable for the forensic analysis methods employed;</text> </paragraph> <paragraph num="(10)"> <text>Have procedures for tracking the receipt and use of commercial reagents;</text> </paragraph> <paragraph num="(11)"> <text>Have procedures for the formulation of in-house reagents in the SOPM; and</text> </paragraph> <paragraph num="(12)"> <text>Test the forensic analysis method, before reporting a forensic analysis result, using:</text> <paragraph num="(a)"> <text>A positive and negative external control for a qualitative forensic analysis; and</text> </paragraph> <paragraph num="(b)"> <text>Known levels of external controls for each analyte in a quantitative forensic analysis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Postmortem Forensic Toxicology. In addition to applicable requirements of this regulation, a laboratory performing postmortem forensic toxicology shall meet the requirements of this section.</text> <paragraph num="(1)"> <text>Screening Tests. A licensee shall:</text> <paragraph num="(a)"> <text>Ensure a postmortem toxicology screening test is appropriate and validated for the type of biological specimen being analyzed; and</text> </paragraph> <paragraph num="(b)"> <text>Perform and document precision studies for a method that uses cut-off values for analyte concentrations.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Confirmatory Tests. A licensee shall:</text> <paragraph num="(a)"> <text>Confirm, if possible, the detection or initial identification of controlled dangerous substances or other toxicants by a second method based on a different chemical principle; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure the confirmatory test is more specific than the initial test for the target analyte, if possible.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Immunoassay. A laboratory shall:</text> <paragraph num="(a)"> <text>Be able to demonstrate sufficient separation in the response between a negative and positive specimen at the cut-off concentration of the immunoassay;</text> </paragraph> <paragraph num="(b)"> <text>Validate the use of an immunoassay method or procedure on a specimen if the method or procedure is not recommended by the manufacturer of the immunoassay; and</text> </paragraph> <paragraph num="(c)"> <text>Use matrix-matched quality control materials for each batch of specimens analyzed with the immunoassay.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Chromatography. A laboratory shall:</text> <paragraph num="(a)"> <text>Analyze calibrators or controls with each batch of specimens for qualitative and quantitative chromatography assays;</text> </paragraph> <paragraph num="(b)"> <text>Establish an acceptable range for each quantitative quality control material; and</text> </paragraph> <paragraph num="(c)"> <text>Use a suitable internal reference standard, when available.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Spectrophotometry. A laboratory shall maintain cuvettes used for spectrophotometry in good optical condition.</text> </paragraph> <paragraph num="(6)"> <text>Mass Spectrometry. A laboratory shall:</text> <paragraph num="(a)"> <text>Establish and adhere to criteria for acceptable mass spectrometric tune;</text> </paragraph> <paragraph num="(b)"> <text>Have written criteria for full scan mass spectrometric identification through library searching; and</text> </paragraph> <paragraph num="(c)"> <text>Compare ion ratios and retention times between reference standards, calibrators, quality control materials, and case specimens when using selected ion monitoring or selected reaction monitoring.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standard Operating Procedures Manual (SOPM)."> <paragraph num="A."> <text>Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are:</text> <paragraph num="(1)"> <text>Documented; and</text> </paragraph> <paragraph num="(2)"> <text>Communicated to, understood by, available to, and implemented by employees performing the activities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that:</text> <paragraph num="(1)"> <text>Documents issued to employees are reviewed and approved for use by authorized employees before issue;</text> </paragraph> <paragraph num="(2)"> <text>The current revision status and distribution of documents is established to preclude use of archived documents;</text> </paragraph> <paragraph num="(3)"> <text>Authorized documents are available at all locations where casework is performed;</text> </paragraph> <paragraph num="(4)"> <text>Archived documents are promptly removed from access or otherwise identified to ensure against unintended use;</text> </paragraph> <paragraph num="(5)"> <text>Documents are uniquely identified, including date of issue or version, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority;</text> </paragraph> <paragraph num="(6)"> <text>Changes to documents are approved by the same authority that issued the document and altered or new text is clearly identified; and</text> </paragraph> <paragraph num="(7)"> <text>Documents in computerized systems have equivalent procedures.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall develop, establish, maintain, implement, and require that technical procedures meet the following:</text> <paragraph num="(1)"> <text>The procedures included are:</text> <paragraph num="(a)"> <text>Generally accepted in the appropriate forensic field or supported by data gathered and recorded in a scientific manner;</text> </paragraph> <paragraph num="(b)"> <text>Available to all appropriate employees;</text> </paragraph> <paragraph num="(c)"> <text>Able to produce valid and accurate results; and</text> </paragraph> <paragraph num="(d)"> <text>Reviewed annually by the director or the director’s designee and this review shall be documented;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>All procedures include, at a minimum:</text> <paragraph num="(a)"> <text>Sample or specimen preparation, as needed for the method;</text> </paragraph> <paragraph num="(b)"> <text>Required quality control, standard, and reference material;</text> </paragraph> <paragraph num="(c)"> <text>Calibration requirements and instructions;</text> </paragraph> <paragraph num="(d)"> <text>Interfering substances and potential sources of error;</text> </paragraph> <paragraph num="(e)"> <text>Literature references;</text> </paragraph> <paragraph num="(f)"> <text>Special analytical and safety precautions;</text> </paragraph> <paragraph num="(g)"> <text>Step-by-step instructions; and</text> </paragraph> <paragraph num="(h)"> <text>Calculations, if required;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The laboratory has a document control procedure to determine when the technical procedure has been discontinued or retired.</text> </paragraph> <paragraph num="(4)"> <text>A laboratory procedure identifies which documents are to be maintained in the case file;</text> </paragraph> <paragraph num="(5)"> <text>All changes to a procedure are approved and signed by the director;</text> </paragraph> <paragraph num="(6)"> <text>The SOPM is available to all forensic analysts and examiners;</text> </paragraph> <paragraph num="(7)"> <text>A departure from the SOPM is:</text> <paragraph num="(a)"> <text>Approved by the laboratory director or qualified designee before implementation;</text> </paragraph> <paragraph num="(b)"> <text>Scientifically validated before implementation;</text> </paragraph> <paragraph num="(c)"> <text>Written; and</text> </paragraph> <paragraph num="(d)"> <text>Communicated to the quality assurance manager;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The laboratory has a procedure for determining the reasons, criteria, or conditions for when a report is not produced;</text> </paragraph> <paragraph num="(9)"> <text>The laboratory has a procedure or policy for technical review of reports that:</text> <paragraph num="(a)"> <text>Defines criteria for the technical review, for example, number or percent of case reports reviewed or corrective action protocol if discrepancies are found;</text> </paragraph> <paragraph num="(b)"> <text>Ensures that a review cannot be performed by the examiner or analyst who prepared the report; and</text> </paragraph> <paragraph num="(c)"> <text>Ensures that a technical review of a one-individual unit is performed at a review percentage determined by the laboratory director by an analyst or examiner of another licensed forensic laboratory, who is qualified within the same disciplines or subdisciplines; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The laboratory has a procedure for administrative review that:</text> <paragraph num="(a)"> <text>Requires that reviews be performed on all case reports;</text> </paragraph> <paragraph num="(b)"> <text>Specifies who may perform the administrative review;</text> </paragraph> <paragraph num="(c)"> <text>Clearly defines how the administrative review is documented; and</text> </paragraph> <paragraph num="(d)"> <text>Requires that reviews be performed before case reports are issued.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee shall ensure that the laboratory has a policy and procedure for the handling of written or oral complaints received from customers, laboratory employees, or other parties.</text> </paragraph> <paragraph num="E."> <text>Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall have:</text> <paragraph num="(1)"> <text>A record of sample signatures and initials of all employees handling specimens and performing analytical work; and</text> </paragraph> <paragraph num="(2)"> <text>A procedure:</text> <paragraph num="(a)"> <text>For periodically monitoring the purity of chemicals used as reference standards; and</text> </paragraph> <paragraph num="(b)"> <text>That defines which postmortem forensic toxicology tests are to be performed on each type of case.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Calibration — General."> <paragraph num="A."> <text>A licensee shall develop, establish, implement, maintain, and follow calibration procedures.</text> <paragraph num="(1)"> <text>If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that:</text> <paragraph num="(a)"> <text>Computer software is performance checked after updates occur or validated;</text> </paragraph> <paragraph num="(b)"> <text>Procedures are established, maintained, and followed to protect and secure the data; and</text> </paragraph> <paragraph num="(c)"> <text>Computers and automated equipment are maintained to ensure proper functioning.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensee shall ensure that:</text> <paragraph num="(a)"> <text>Reference standards are calibrated by an entity that can provide traceability;</text> </paragraph> <paragraph num="(b)"> <text>Measuring devices including rulers, weights, pipettes, balances, thermometers, and other devices that affect a forensic analysis result are calibrated against a reference standard traceable to the International System of Units, if available, as required by the manufacturer or forensic laboratory’s quality assurance program;</text> </paragraph> <paragraph num="(c)"> <text>Calibration, if applicable, is performed:</text> <paragraph num="(i)"> <text>Before initial use and before the recalibrated item is returned to service;</text> </paragraph> <paragraph num="(ii)"> <text>Following service or maintenance; and</text> </paragraph> <paragraph num="(iii)"> <text>At intervals specified by the manufacturer or more frequently as determined by the technical leader or quality assurance manager; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>All calibration activities are documented.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:</text> <paragraph num="(1)"> <text>Include in the method calibration:</text> <paragraph num="(a)"> <text>A sufficient number of calibrators and quality control samples in each batch that are consistent with the analysis being performed; and</text> </paragraph> <paragraph num="(b)"> <text>Analyses being performed on unusual specimens that:</text> <paragraph num="(i)"> <text>Use appropriate matrix-matched calibrators, when possible; and</text> </paragraph> <paragraph num="(ii)"> <text>Are prepared and tested concurrently with the specimen; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have a policy that defines a specimen that has a unique matrix.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Validation and Performance Checks."> <paragraph num="A."> <text>The licensee shall:</text> <paragraph num="(1)"> <text>Separately perform a validation or conduct a performance check on standard methods before use;</text> </paragraph> <paragraph num="(2)"> <text>Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain documentation of all method validation and performance check activities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that validation includes, but is not limited to:</text> <paragraph num="(1)"> <text>Literature references;</text> </paragraph> <paragraph num="(2)"> <text>Limitations of the method;</text> </paragraph> <paragraph num="(3)"> <text>Sources of error;</text> </paragraph> <paragraph num="(4)"> <text>Specificity;</text> </paragraph> <paragraph num="(5)"> <text>Sensitivity;</text> </paragraph> <paragraph num="(6)"> <text>Accuracy; and</text> </paragraph> <paragraph num="(7)"> <text>Reproducibility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall ensure that performance checks, if applicable, are performed:</text> <paragraph num="(1)"> <text>Before:</text> <paragraph num="(a)"> <text>Initial use of computers and automated equipment; and</text> </paragraph> <paragraph num="(b)"> <text>Computers or automated equipment are returned to use for casework;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Following servicing or maintenance;</text> </paragraph> <paragraph num="(3)"> <text>At intervals specified by the manufacturer; and</text> </paragraph> <paragraph num="(4)"> <text>As needed as determined by the laboratory director or the laboratory director’s designee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A technical leader and a laboratory director shall approve all testing methods before the testing methods are put into use.</text> </paragraph> <paragraph num="E."> <text>A licensee shall ensure that:</text> <paragraph num="(1)"> <text>Reference samples are used for method validation and performance checks;</text> </paragraph> <paragraph num="(2)"> <text>Validation and performance checks include a statement as to whether the method is fit for the intended use; and</text> </paragraph> <paragraph num="(3)"> <text>All new procedures and modifications of current procedures are validated and documented before being used in case work.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Examination and Analysis."> <paragraph num="A."> <text>A licensee shall develop, establish, maintain, implement, and follow examination and analysis procedures.</text> </paragraph> <paragraph num="B."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Ensure that all evidence is given a unique identifier;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that, when computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of examination or analysis data:</text> <paragraph num="(a)"> <text>Computer software is validated;</text> </paragraph> <paragraph num="(b)"> <text>Procedures are established and maintained to protect and secure the data; and</text> </paragraph> <paragraph num="(c)"> <text>Computers and automated equipment are maintained to ensure proper functioning;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have a policy for securing short-term and long-term storage of documents, evidence, and reports, which includes:</text> <paragraph num="(a)"> <text>Limited access; and</text> </paragraph> <paragraph num="(b)"> <text>Environmental controls;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ensure each individual sub-sample has a unique identifier, when evidentiary samples are subdivided;</text> </paragraph> <paragraph num="(5)"> <text>Ensure that all positive comparative analyses are verified by a second independent qualified examiner or analyst who has documented expertise in the examination that was performed, and the verification is documented; and</text> </paragraph> <paragraph num="(6)"> <text>Have a policy for securing evidence that is in the process of being examined or analyzed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Examinations and Analysis by Subcontractors.</text> <paragraph num="(1)"> <text>All subcontractors shall be licensed as a forensic laboratory in the State, regardless of location, unless a waiver has been obtained for a rare or unique test as required by COMAR 10.51.03.01A(4).</text> </paragraph> <paragraph num="(2)"> <text>A licensee shall ensure:</text> <paragraph num="(a)"> <text>The customer who ordered the analyses is notified of the laboratory’s intention to subcontract specific services for testing;</text> </paragraph> <paragraph num="(b)"> <text>All subcontractors issue reports only to the forensic laboratory that ordered the testing; and</text> </paragraph> <paragraph num="(c)"> <text>All remaining evidence is returned to the forensic laboratory by the subcontractor.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Test Reports — General."> <paragraph num="A."> <text>A licensee shall ensure that a test report includes but is not limited to the following:</text> <paragraph num="(1)"> <text>Name and physical address of the laboratory;</text> </paragraph> <paragraph num="(2)"> <text>A unique identifier on each page of the report;</text> </paragraph> <paragraph num="(3)"> <text>Identification of the forensic analysis method used;</text> </paragraph> <paragraph num="(4)"> <text>A clear identification of each item tested including a description of the item’s condition;</text> </paragraph> <paragraph num="(5)"> <text>The date each forensic analysis was completed;</text> </paragraph> <paragraph num="(6)"> <text>Units of measurement, if applicable;</text> </paragraph> <paragraph num="(7)"> <text>The name and written or electronic signature of the examiner or analyst responsible for:</text> <paragraph num="(a)"> <text>Performance of the forensic analysis;</text> </paragraph> <paragraph num="(b)"> <text>Interpretations of forensic analysis results; and</text> </paragraph> <paragraph num="(c)"> <text>Opinions;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Opinions and interpretations;</text> </paragraph> <paragraph num="(9)"> <text>When applicable, a statement of uncertainty of measurement if the uncertainty of measurement may affect the interpretation of the results of the forensic analysis;</text> </paragraph> <paragraph num="(10)"> <text>The date report was generated;</text> </paragraph> <paragraph num="(11)"> <text>The indication of the end of the report on the report’s last page; and</text> </paragraph> <paragraph num="(12)"> <text>If applicable, a statement that the analysis was performed by another laboratory and identifies the facility that actually performed the analysis.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that any information from §A(1)—(12) of this regulation that is not included in the test report is documented in the case record.</text> </paragraph> <paragraph num="C."> <text>A licensee shall ensure that test reports:</text> <paragraph num="(1)"> <text>Are produced when analytical testing is performed on evidence;</text> </paragraph> <paragraph num="(2)"> <text>Contain opinions and conclusions and the name of the report’s author;</text> </paragraph> <paragraph num="(3)"> <text>Report results accurately, clearly, unambiguously, and objectively; and</text> </paragraph> <paragraph num="(4)"> <text>Utilize a page numbering system that includes either the total number of pages or a mark to signify the end of the document.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee shall ensure that amended reports:</text> <paragraph num="(1)"> <text>Clearly state that the report has been amended;</text> </paragraph> <paragraph num="(2)"> <text>Reference the original report;</text> </paragraph> <paragraph num="(3)"> <text>Are placed or associated with the original report in the case file; and</text> </paragraph> <paragraph num="(4)"> <text>Are provided to the customers.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reports — Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:</text> <paragraph num="(1)"> <text>Have a procedure or policy for technical review of reports, which includes at a minimum:</text> <paragraph num="(a)"> <text>Chain of custody documentation;</text> </paragraph> <paragraph num="(b)"> <text>Validity of analytical data; and</text> </paragraph> <paragraph num="(c)"> <text>Quality control data;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Include on the test report the name of the submitting agency or individual;</text> </paragraph> <paragraph num="(3)"> <text>Indicate qualitative test results using the:</text> <paragraph num="(a)"> <text>Term “Positive” if the test result is positive for the presence of the substance tested; and</text> </paragraph> <paragraph num="(b)"> <text>Term “None detected” if the test result is negative for the presence of the substance tested;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have quantitative results identified using correct nomenclature;</text> </paragraph> <paragraph num="(5)"> <text>Have preliminary reports clearly indicate that the:</text> <paragraph num="(a)"> <text>Results are unconfirmed and subject to verification;</text> </paragraph> <paragraph num="(b)"> <text>Testing is incomplete; and</text> </paragraph> <paragraph num="(c)"> <text>Subsequent results, where appropriate, may affect the final report and interpretation of the report;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Clearly identify test results performed by a subcontractor;</text> </paragraph> <paragraph num="(7)"> <text>Clearly identify revised reports or addenda using the same identifying information as the original report, for reports that contain additional testing after the original test results were reported; and</text> </paragraph> <paragraph num="(8)"> <text>Indicate on the final report the name of the laboratory that actually performed the test if specimens were referred to another laboratory for analysis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Employee Training and Competency."> <paragraph num="A."> <text>A licensee shall develop, establish, maintain, implement, and follow a written training program for all technical skills in each discipline and subdiscipline for each new or untrained employee and employees who need remedial training.</text> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that available to all technical employees is a discipline-specific training program that includes:</text> <paragraph num="(1)"> <text>All aspects of the work being performed by the laboratory for each discipline and subdiscipline in which the laboratory performs case work;</text> </paragraph> <paragraph num="(2)"> <text>Ethics and data integrity;</text> </paragraph> <paragraph num="(3)"> <text>Criminal and civil law procedures;</text> </paragraph> <paragraph num="(4)"> <text>Criteria or requirements to demonstrate competence;</text> </paragraph> <paragraph num="(5)"> <text>Moot court training if court testimony may be required; and</text> </paragraph> <paragraph num="(6)"> <text>Expert witness training if expert witness testimony may be required.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall ensure that training records include at least:</text> <paragraph num="(1)"> <text>Competency assessments;</text> </paragraph> <paragraph num="(2)"> <text>Proficiency testing results;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of all training;</text> </paragraph> <paragraph num="(4)"> <text>Documentation of training that occurred at a previous job, if applicable;</text> </paragraph> <paragraph num="(5)"> <text>Written authorization by the laboratory director and technical leader to conduct independent casework in each type of testing assigned; and</text> </paragraph> <paragraph num="(6)"> <text>Documentation of all continuing education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Equipment Maintenance."> <paragraph num="A."> <text>General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy.</text> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory’s or manufacturer’s specifications, or both, as determined by the director.</text> </paragraph> <paragraph num="C."> <text>A licensee shall ensure that records are maintained on all items of equipment including at a minimum:</text> <paragraph num="(1)"> <text>Identity of the item of equipment and the equipment’s ancillary parts;</text> </paragraph> <paragraph num="(2)"> <text>Manufacturer’s name and serial number or other unique identifier;</text> </paragraph> <paragraph num="(3)"> <text>Performance checks ensuring the equipment complies with the manufacturer’s specifications;</text> </paragraph> <paragraph num="(4)"> <text>Current location, if applicable;</text> </paragraph> <paragraph num="(5)"> <text>Manufacturer’s instructions or operating manual;</text> </paragraph> <paragraph num="(6)"> <text>Dates and results of calibrations, adjustments, and service and date of next calibration;</text> </paragraph> <paragraph num="(7)"> <text>Documentation of all maintenance performed, including date and signature of the individual performing the maintenance; and</text> </paragraph> <paragraph num="(8)"> <text>Documentation of any damage, malfunction, modification, or repair to the equipment.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee shall ensure that any equipment that gives questionable results or is not functioning properly is immediately taken out of use and the equipment:</text> <paragraph num="(1)"> <text>Is clearly labeled as out of service;</text> </paragraph> <paragraph num="(2)"> <text>Is examined and repaired or retired;</text> </paragraph> <paragraph num="(3)"> <text>Is calibrated or shown to perform correctly before being put back into service; and</text> </paragraph> <paragraph num="(4)"> <text>Has forensic analysis results on previously examined evidence evaluated for accuracy back to the previous calibration.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee shall ensure that the equipment, including both hardware and software, is safeguarded from adjustments that invalidate or alter calibrations or test examinations and analyses.</text> </paragraph> <paragraph num="F."> <text>A licensee shall ensure that operator’s manuals for all equipment and instruments are available to all examiners and analysts who use the equipment or instruments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Case Records."> <paragraph num="A."> <text>A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by:</text> <paragraph num="(1)"> <text>Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;</text> </paragraph> <paragraph num="(2)"> <text>Using electronic signatures only if a security protocol is in place;</text> </paragraph> <paragraph num="(3)"> <text>Having a tracking policy and system for electronic record changes, when the electronic document is complete; and</text> </paragraph> <paragraph num="(4)"> <text>Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In regard to examination documents, a licensee shall ensure that:</text> <paragraph num="(1)"> <text>If information is recorded on both sides, each side of a page is considered a separate page;</text> </paragraph> <paragraph num="(2)"> <text>If examination documents consist of multiple pages, a page numbering system that includes either the total number of pages or a mark signifying the end of the document is used;</text> </paragraph> <paragraph num="(3)"> <text>In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data;</text> </paragraph> <paragraph num="(4)"> <text>An examination document:</text> <paragraph num="(a)"> <text>Includes details to support the conclusions and opinions reported by each examiner or analyst;</text> </paragraph> <paragraph num="(b)"> <text>Is free of erasures or obliterations;</text> </paragraph> <paragraph num="(c)"> <text>Is marked with a unique identifier and the examiner’s or analyst’s handwritten initials or electronic signature; and</text> </paragraph> <paragraph num="(d)"> <text>Includes each date casework or an analysis was performed;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If an individual in addition to the examiner or analyst interprets or reports the results, both individuals initial or electronically sign each page of the examination documents;</text> </paragraph> <paragraph num="(6)"> <text>Abbreviations and symbols are defined in the SOPM;</text> </paragraph> <paragraph num="(7)"> <text>Erroneous results, corrections, and amendments:</text> <paragraph num="(a)"> <text>Are crossed out with a single line, not erased, and not deleted or made illegible; and</text> </paragraph> <paragraph num="(b)"> <text>Have corrections entered beside the erroneous result;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>All corrections and amendments are initialed and dated;</text> </paragraph> <paragraph num="(9)"> <text>If electronically signed, measures are taken to ensure the signature is secure; and</text> </paragraph> <paragraph num="(10)"> <text>There is no loss or change of the original documents.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Complaints."> <paragraph num="A."> <text>A licensee shall retain all complaint records and documentation of the investigations and corrective actions taken by the laboratory.</text> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that complaint documents include at least the:</text> <paragraph num="(1)"> <text>Name and organization of complainant, if applicable;</text> </paragraph> <paragraph num="(2)"> <text>Date of complaint;</text> </paragraph> <paragraph num="(3)"> <text>Details of complaint;</text> </paragraph> <paragraph num="(4)"> <text>Corrective action and resolution; and</text> </paragraph> <paragraph num="(5)"> <text>Notification of the complainant as to the resolution of the complaint.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall forward all complaints to the laboratory director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Subcontractors."> <text>A licensee shall:</text> <paragraph num="A."> <text>Maintain a list of all subcontractors to which forensic analyses are referred;</text> </paragraph> <paragraph num="B."> <text>Be responsible for the subcontractor’s forensic analysis or examination;</text> </paragraph> <paragraph num="C."> <text>Ensure that forensic analysis results from the subcontractor are written or in a secured electronic form;</text> </paragraph> <paragraph num="D."> <text>Ensure that if alternative methods are used, the customer is notified before performing the examination or analysis;</text> </paragraph> <paragraph num="E."> <text>Establish and use appropriate review procedures to ensure the integrity of:</text> <paragraph num="(1)"> <text>Outsourced samples; and</text> </paragraph> <paragraph num="(2)"> <text>Data received from the subcontractor; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Establish and use appropriate review procedures to verify compliance with applicable State regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Facilities."> <paragraph num="A."> <text>Facility Administration. A licensee shall ensure that a laboratory:</text> <paragraph num="(1)"> <text>Is adequate for the testing services offered;</text> </paragraph> <paragraph num="(2)"> <text>Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and</text> </paragraph> <paragraph num="(3)"> <text>Has the required safety equipment as defined by the laboratory SOPM.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Security. A licensee shall:</text> <paragraph num="(1)"> <text>Control and limit access to areas of the laboratory to those persons who regularly work in an area or are designated by the laboratory director as having access to an area; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that:</text> <paragraph num="(a)"> <text>Entrances and exits have adequate security measures;</text> </paragraph> <paragraph num="(b)"> <text>Internal areas that are required to have controlled or limited access are protected by a locked system;</text> </paragraph> <paragraph num="(c)"> <text>The distribution of all keys, magnetic cards, and entry devices is documented and authorized by the director;</text> </paragraph> <paragraph num="(d)"> <text>The facility is secure; and</text> </paragraph> <paragraph num="(e)"> <text>All short-term and long-term storage areas have controlled or limited access and have a lock system in place.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Safety. A licensee shall:</text> <paragraph num="(1)"> <text>Have a safety policy and procedure, that is reviewed annually;</text> </paragraph> <paragraph num="(2)"> <text>Designate an employee as the safety officer with responsibilities defined by the licensee;</text> </paragraph> <paragraph num="(3)"> <text>Have appropriate safety policies and procedures;</text> </paragraph> <paragraph num="(4)"> <text>Demonstrate appropriate safety policies and procedures;</text> </paragraph> <paragraph num="(5)"> <text>Have appropriate safety devices and equipment available and in close proximity to the appropriate areas; and</text> </paragraph> <paragraph num="(6)"> <text>Be in compliance with all federal, State, and local regulations regarding the handling and disposal of infectious materials, chemicals, radioactive materials, sharps, and glassware.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Ethics and Data Integrity Policy — Requirement."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Establish and maintain a written ethics and data integrity policy to be followed by all forensic laboratory employees, which includes the items set forth in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Provide access to the information, training, and resources needed by all forensic laboratory employees to comply with applicable federal and State laws, including ethics laws and regulations and the ethics and data integrity policy required in §A(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Provide formal ethics and data integrity training:</text> <paragraph num="(a)"> <text>As part of new employee orientation; and</text> </paragraph> <paragraph num="(b)"> <text>On an annual basis for all current employees;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Develop and utilize an employee ethics and data integrity agreement, for each employee to sign annually after training, acknowledging, and certifying that the employee has read, understands, and will follow the forensic laboratory ethics and data integrity policy; and</text> </paragraph> <paragraph num="(5)"> <text>Provide a working environment in the forensic laboratory that:</text> <paragraph num="(a)"> <text>Prevents employees from being subject to inappropriate pressures, coercion, intimidation, unethical laboratory dilemmas, or bribery from internal or external sources; and</text> </paragraph> <paragraph num="(b)"> <text>Promotes and maintains effective bilateral communication through the chain-of-command, regarding concerns, inquiries, and allegations pertaining to:</text> <paragraph num="(i)"> <text>Suspected or actual unethical conduct;</text> </paragraph> <paragraph num="(ii)"> <text>Data integrity issues;</text> </paragraph> <paragraph num="(iii)"> <text>Questionable practices; or</text> </paragraph> <paragraph num="(iv)"> <text>Questions concerning forensic analysis procedures or results.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall ensure that a licensee’s ethics and data integrity policy includes at least the following topics, requirements, and procedures:</text> <paragraph num="(1)"> <text>An employee’s responsibility to report any activity or behavior by any other employee, subcontractor, or vendor that the employee has reason to believe violates applicable laws, rules, and regulations or the forensic laboratory’s ethics and data integrity policy;</text> </paragraph> <paragraph num="(2)"> <text>The disciplinary action an employee will be subject to if the employee:</text> <paragraph num="(a)"> <text>Makes or produces a report that the employee knows to be false or misleading;</text> </paragraph> <paragraph num="(b)"> <text>Is found falsifying, short-cutting, camouflaging, or misrepresenting any information or facts about forensic analysis procedure, result, reports, or data management; or</text> </paragraph> <paragraph num="(c)"> <text>Otherwise engages in conduct or behavior that violates the:</text> <paragraph num="(i)"> <text>Forensic laboratory’s ethics and data integrity policy; or</text> </paragraph> <paragraph num="(ii)"> <text>Established forensic laboratory practices;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Procedures for reporting, handling, and investigating complaints of unethical conduct and violations or suspected violations of the forensic laboratory’s ethics and data integrity policy;</text> </paragraph> <paragraph num="(4)"> <text>Requiring employees to:</text> <paragraph num="(a)"> <text>Act impartially and not give preferential treatment to any person;</text> </paragraph> <paragraph num="(b)"> <text>Exhibit exemplary conduct and use honest efforts in the performance of duties and responsibilities;</text> </paragraph> <paragraph num="(c)"> <text>Perform a forensic analysis in a manner that:</text> <paragraph num="(i)"> <text>Is independent of internal and external influences;</text> </paragraph> <paragraph num="(ii)"> <text>Is objective; and</text> </paragraph> <paragraph num="(iii)"> <text>Assures that results are accurate, precise, and of known and documented quality; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Understand the:</text> <paragraph num="(i)"> <text>Serious implications and consequences of unethical conduct, intent to defraud, or any impropriety in performing forensic analyses; and</text> </paragraph> <paragraph num="(ii)"> <text>Zero tolerance policy regarding an employee who engages in any form of conduct or behavior that is a violation of the ethics and data integrity policy required in §A of this regulation or any forensic laboratory practice that is not authorized by a licensee’s established procedures; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Prohibiting an employee from:</text> <paragraph num="(a)"> <text>Soliciting or accepting any gift of goods or services or other benefit of value from a person or entity:</text> <paragraph num="(i)"> <text>Seeking action from or doing business with the forensic laboratory; or</text> </paragraph> <paragraph num="(ii)"> <text>Whose interests may be substantially affected by the performance or nonperformance of the employee’s duties and responsibilities;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Holding a financial or personal interest that conflicts with the conscientious and ethical performance of duties and responsibilities;</text> </paragraph> <paragraph num="(c)"> <text>Engaging in a transaction allowing the improper use of confidential information to further a private interest;</text> </paragraph> <paragraph num="(d)"> <text>Conducting an action that violates the standards and requirements set forth in this subtitle or the licensee’s ethics and data integrity policy; and</text> </paragraph> <paragraph num="(e)"> <text>Engaging in outside employment or activities that conflict with the conscientious and ethical performance of duties and responsibilities.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Nonretaliation."> <paragraph num="A."> <text>A licensee shall establish, maintain, and follow a nonretaliation policy that ensures that an employee who in good faith reports to the Secretary or the Department an issue related to data integrity or unethical or fraudulent conduct will not be subject to any form of discrimination or retaliation.</text> </paragraph> <paragraph num="B."> <text>An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation or possible violation of a standard or requirement set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, including a standard or requirement related to data integrity or unethical or fraudulent conduct.</text> </paragraph> <paragraph num="C."> <text>A licensee shall post the document developed by the Secretary and approved by the Department informing employees of a forensic laboratory of the procedures to report instances of noncompliance or other violations of the standards and requirements set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The Department shall develop a forensic laboratory noncompliance document that:</text> <paragraph num="(1)"> <text>Has contact information for reporting violations of standards and requirements for forensic laboratories, including address, phone numbers, fax number, and website;</text> </paragraph> <paragraph num="(2)"> <text>Has a statement about nonretaliation and nondiscrimination against anyone reporting noncompliance or other violations for forensic laboratories; and</text> </paragraph> <paragraph num="(3)"> <text>Is signed by the director of the Office of Health Care Quality.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall distribute to each quality assurance manager of a forensic laboratory the document referenced in §D of this regulation.</text> </paragraph> <paragraph num="F."> <text>A licensee shall ensure that the document referenced in §D of this regulation is posted in a conspicuous place visible to all forensic laboratory employees.</text> </paragraph> <paragraph num="G."> <text>A licensee may not discriminate or retaliate against an employee of a forensic laboratory who:</text> <paragraph num="(1)"> <text>In good faith makes a report to the Secretary as set forth in this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Has agreed to cooperate with an investigation of the forensic laboratory.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A licensee may be subject to the sanctions set forth in this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, if the licensee discriminates or retaliates against an employee who in good faith makes a report to the Secretary as set forth in this regulation, including:</text> <paragraph num="(1)"> <text>Failing to promote the employee or provide an employment-related benefit for which the employee would otherwise be eligible;</text> </paragraph> <paragraph num="(2)"> <text>Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the employee; or</text> </paragraph> <paragraph num="(3)"> <text>Taking a personnel action that is retaliatory to the employee.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An employee of a forensic laboratory who has been discriminated or retaliated against in violation of this regulation or Health-General Article, §17–2A–10, Annotated Code of Maryland, may initiate an action within 2 years of the discrimination or retaliation that is the basis for the action, and, on prevailing, shall be entitled to:</text> <paragraph num="(1)"> <text>Reinstatement;</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement for lost wages;</text> </paragraph> <paragraph num="(3)"> <text>Work benefits lost as a result of the unlawful acts of the licensee; and</text> </paragraph> <paragraph num="(4)"> <text>Reasonable attorney’s fees and costs associated with pursuing the action.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880)</annotation> </annotations> </chapter> <chapter num="06" heading="Employees"> <regulation prefix="Regulation" num=".01" heading="Employees — Required."> <paragraph num="A."> <text>A licensee operating a forensic laboratory shall employ or otherwise engage the services of qualified employees, including:</text> <paragraph num="(1)"> <text>A director;</text> </paragraph> <paragraph num="(2)"> <text>A technical leader;</text> </paragraph> <paragraph num="(3)"> <text>A quality assurance manager; and</text> </paragraph> <paragraph num="(4)"> <text>Forensic analysts and examiners.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Based on the scope of forensic testing services or categories offered or performed by the forensic laboratory, a licensee:</text> <paragraph num="(1)"> <text>Shall employ a sufficient number of qualified forensic analysts and examiners to:</text> <paragraph num="(a)"> <text>Accomplish the forensic laboratory’s mission and goals as determined by the director;</text> </paragraph> <paragraph num="(b)"> <text>Meet the forensic laboratory’s established priority protocols for a forensic analysis; and</text> </paragraph> <paragraph num="(c)"> <text>Ensure that the quality of forensic testing services is not jeopardized; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May employ more than one technical leader.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The laboratory director may identify or designate an individual in an equivalent role, position, or title for an employee required in §A of this regulation if the individual:</text> <paragraph num="(1)"> <text>Meets the qualifications for the position; and</text> </paragraph> <paragraph num="(2)"> <text>Fulfills the responsibilities of the designated required employees as set forth in this subtitle.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual employed by a licensee may serve in one or more roles or positions of the employees required in §A of this regulation if the:</text> <paragraph num="(1)"> <text>Individual meets the qualifications for and fulfills the responsibilities of the required employees as set forth in this subtitle; and</text> </paragraph> <paragraph num="(2)"> <text>Duties and responsibilities are delegated in writing to the assigned individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Employees — Character and Education Verification."> <paragraph num="A."> <text>A licensee shall establish and follow written procedures for verifying the background and education of forensic laboratory employees.</text> </paragraph> <paragraph num="B."> <text>A licensee shall verify the background and education of an individual by a:</text> <paragraph num="(1)"> <text>Background investigation;</text> </paragraph> <paragraph num="(2)"> <text>Review of the individual’s grade transcript from the college or university that the individual attended, that is:</text> <paragraph num="(a)"> <text>The original record or transcript document; or</text> </paragraph> <paragraph num="(b)"> <text>An official certified copy of the transcript;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Test for abuse of controlled dangerous substances; and</text> </paragraph> <paragraph num="(4)"> <text>Polygraph examination, if available.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Employees — Qualification Effective Dates."> <paragraph num="A."> <text>Regardless of how an individual’s role, position, or title is identified by a licensee, on or after January 1, 2012, an individual who begins employment with a licensee in a forensic laboratory shall meet the appropriate employee qualifications and requirements as set forth in this subtitle for a:</text> <paragraph num="(1)"> <text>Director;</text> </paragraph> <paragraph num="(2)"> <text>Technical leader;</text> </paragraph> <paragraph num="(3)"> <text>Quality assurance manager;</text> </paragraph> <paragraph num="(4)"> <text>Forensic analyst or examiner; and</text> </paragraph> <paragraph num="(5)"> <text>Person in the chain of casework who could affect the forensic analysis results, including technicians.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee shall deem an individual who is performing the function of a forensic laboratory director, as set forth in this chapter, on or before December 31, 2011, as:</text> <paragraph num="(1)"> <text>Meeting the qualifications of a forensic laboratory director; and</text> </paragraph> <paragraph num="(2)"> <text>Fulfilling the duties and responsibilities of the director as set forth in this subtitle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee shall deem an individual, other than the director, who is performing the function of one or more of the required employees, as set forth in Regulation .01 of this chapter, on or before December 31, 2011, as:</text> <paragraph num="(1)"> <text>Meeting the qualifications for the designated role, position, or title if the individual is authorized in writing by the director; and</text> </paragraph> <paragraph num="(2)"> <text>Fulfilling the duties and responsibilities of the designated position as set forth in this subtitle.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Deemed Qualification.</text> <paragraph num="(1)"> <text>The deemed qualification for forensic laboratory employees as set forth in §§B and C of this regulation is limited to the specific role or function of an individual on or before December 31, 2011.</text> </paragraph> <paragraph num="(2)"> <text>The deemed qualification of an individual in a specific role or function as set forth in §§B and C of this regulation is permanent and portable.</text> </paragraph> <paragraph num="(3)"> <text>If the role of an individual employed by a licensee changes, the individual, before serving in the new role, shall:</text> <paragraph num="(a)"> <text>Meet the appropriate qualifications for the role as set forth in this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>From January 1, 2012, through December 31, 2018, meet the employee qualifications established by the laboratory director for a forensic non-Biology-DNA:</text> <paragraph num="(i)"> <text>Technical leader;</text> </paragraph> <paragraph num="(ii)"> <text>Quality assurance manager; or</text> </paragraph> <paragraph num="(iii)"> <text>Analyst or examiner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Sunset of Deemed Qualifications. The deemed qualification of an individual in a specific role or function as set forth in §D(3)(b) of this regulation:</text> <paragraph num="(a)"> <text>Is not permanent; and</text> </paragraph> <paragraph num="(b)"> <text>Expires on December 31, 2018.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Director — Requirement."> <text>A licensee shall employ a forensic laboratory director who:</text> <paragraph num="A."> <text>Meets the qualifications set forth in this chapter; and</text> </paragraph> <paragraph num="B."> <text>Is responsible for the overall operation and administration of the laboratory.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Director — Qualifications."> <text>A director of a forensic laboratory shall:</text> <paragraph num="A."> <text>Hold an earned master’s or doctoral degree from an accredited institution in:</text> <paragraph num="(1)"> <text>Forensic science;</text> </paragraph> <paragraph num="(2)"> <text>A natural science such as chemistry, physics, or biology; or</text> </paragraph> <paragraph num="(3)"> <text>A subspecialty of a natural science such as organic chemistry, biochemistry, or molecular biology; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have at least:</text> <paragraph num="(1)"> <text>3 years of documented forensic laboratory experience; and</text> </paragraph> <paragraph num="(2)"> <text>2 years of managerial or supervisory experience.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Director — General Duties and Responsibilities."> <paragraph num="A."> <text>A director of a forensic laboratory is responsible for the overall operation and administration of the forensic laboratory.</text> </paragraph> <paragraph num="B."> <text>A director of a forensic laboratory shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations, including but not limited to:</text> <paragraph num="(1)"> <text>Employing individuals who are competent to:</text> <paragraph num="(a)"> <text>Perform a forensic analysis; and</text> </paragraph> <paragraph num="(b)"> <text>Record and report a forensic analysis:</text> <paragraph num="(i)"> <text>Promptly within the priority protocols established by the director;</text> </paragraph> <paragraph num="(ii)"> <text>Accurately; and</text> </paragraph> <paragraph num="(iii)"> <text>Proficiently; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ensuring compliance with the requirements set forth in this subtitle.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A forensic laboratory director may:</text> <paragraph num="(1)"> <text>If qualified, perform the duties of a:</text> <paragraph num="(a)"> <text>Technical leader;</text> </paragraph> <paragraph num="(b)"> <text>Quality assurance manager; and</text> </paragraph> <paragraph num="(c)"> <text>Forensic analysis employee; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Delegate a duty or responsibility set forth in this subtitle to an employee who is qualified to carry out the delegated duty or responsibility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a forensic laboratory director delegates the performance of the director’s duties or responsibilities as set forth in this subtitle, the forensic laboratory director shall ensure that the delegated duties and responsibilities are properly performed as required by this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Director — Specific Duties and Responsibilities."> <text>A forensic laboratory director shall:</text> <paragraph num="A."> <text>Be accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation as needed;</text> </paragraph> <paragraph num="B."> <text>Ensure that:</text> <paragraph num="(1)"> <text>Forensic testing and examination systems developed and used for each forensic analysis performed in the laboratory provide quality laboratory services for all aspects of test and examination performance including the pre-analytic, analytic, and post-analytic phases of the forensic analysis;</text> </paragraph> <paragraph num="(2)"> <text>The physical plant and environmental conditions of the forensic laboratory are appropriate for the testing performed;</text> </paragraph> <paragraph num="(3)"> <text>Forensic laboratory employees are provided a safe work environment and are protected from physical, chemical, and biological hazards;</text> </paragraph> <paragraph num="(4)"> <text>A forensic analysis method selected for use in the laboratory has the capability of providing an accurate and reliable result with known or defined uncertainty;</text> </paragraph> <paragraph num="(5)"> <text>Verification procedures used are adequate to determine the accuracy, precision, uncertainty, and other pertinent performance characteristics of each forensic analysis method;</text> </paragraph> <paragraph num="(6)"> <text>Forensic analysis employees perform the forensic analysis methods as required by the laboratory’s established procedures to assure accurate and reliable results;</text> </paragraph> <paragraph num="(7)"> <text>The forensic laboratory participates in and uses a Department-approved proficiency testing provider as set forth in this subtitle, for each forensic analysis the laboratory performs or offers to perform;</text> </paragraph> <paragraph num="(8)"> <text>Received proficiency test reports are reviewed by the appropriate forensic analysis employees to:</text> <paragraph num="(a)"> <text>Evaluate the laboratory’s performance; and</text> </paragraph> <paragraph num="(b)"> <text>Identify any problems which require corrective action;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A corrective action plan is followed when a proficiency test result is found to be unacceptable or unsatisfactory;</text> </paragraph> <paragraph num="(10)"> <text>Quality control, quality assurance and assessment, and ethics and data integrity programs are established, maintained, and followed as set forth in this subtitle;</text> </paragraph> <paragraph num="(11)"> <text>A case file is maintained for a minimum of 10 years after the case is received;</text> </paragraph> <paragraph num="(12)"> <text>Acceptable levels of analytical performance for each forensic analysis are established and maintained;</text> </paragraph> <paragraph num="(13)"> <text>Remedial actions are taken and documented if a deviation from the forensic laboratory’s established performance characteristics is identified;</text> </paragraph> <paragraph num="(14)"> <text>Procedures and mechanisms are established, maintained, and followed to preserve evidentiary sample and specimen integrity and identity throughout the forensic analysis process;</text> </paragraph> <paragraph num="(15)"> <text>Forensic test and examination results are reported only when the forensic analysis system is functioning properly;</text> </paragraph> <paragraph num="(16)"> <text>Reports of forensic analysis results include pertinent information required for correct interpretation;</text> </paragraph> <paragraph num="(17)"> <text>Consultation is available to the forensic laboratory’s clients on matters relating to the quality of the reported forensic analysis results and interpretation;</text> </paragraph> <paragraph num="(18)"> <text>There is on-site supervision of forensic analyses and examinations being performed;</text> </paragraph> <paragraph num="(19)"> <text>An employee has sufficient education and experience related to the forensic analyses and examinations being performed, has completed the training for the type and complexity of tests and examinations performed, and has demonstrated reliable test performance and examination operations to provide and report accurate results;</text> </paragraph> <paragraph num="(20)"> <text>Before performing a forensic analysis on an evidentiary sample or specimen, an employee has demonstrated reliable and proficient analysis and the providing and reporting of accurate results;</text> </paragraph> <paragraph num="(21)"> <text>Policies and procedures are established for monitoring the performance of employees who conduct pre-analytical, analytical, and post-analytical phases of the forensic analysis process to assure that:</text> <paragraph num="(a)"> <text>Employees are competent and maintain competency to:</text> <paragraph num="(i)"> <text>Process samples and specimens;</text> </paragraph> <paragraph num="(ii)"> <text>Perform forensic tests and examinations; and</text> </paragraph> <paragraph num="(iii)"> <text>Report forensic analysis results promptly and proficiently; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Employee needs for remedial training or continuing education to improve skills are identified, when necessary; and</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>A procedure manual is available to and followed by all employees responsible for any aspect of the forensic analysis process;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Employ a sufficient number of forensic laboratory employees with the required education, experience, and training, and in accordance with the employee responsibilities set forth in this chapter to:</text> <paragraph num="(1)"> <text>Provide consultation and court testimony;</text> </paragraph> <paragraph num="(2)"> <text>Supervise the performance of forensic analyses;</text> </paragraph> <paragraph num="(3)"> <text>Collect, process, and store evidentiary samples and specimens;</text> </paragraph> <paragraph num="(4)"> <text>Perform forensic analysis procedures; and</text> </paragraph> <paragraph num="(5)"> <text>Report forensic analysis results promptly and proficiently;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Establish and specify, in writing, the duties and responsibilities of each:</text> <paragraph num="(1)"> <text>Consultant;</text> </paragraph> <paragraph num="(2)"> <text>Technical leader; and</text> </paragraph> <paragraph num="(3)"> <text>Individual engaged in the performance of the pre-analytic, analytic, and post-analytic phases of a forensic analysis;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Identify in the written duties and responsibilities required in §D of this regulation:</text> <paragraph num="(1)"> <text>What forensic tests, examinations, and procedures each individual is authorized to perform;</text> </paragraph> <paragraph num="(2)"> <text>The competencies required to perform each forensic test, examination, and procedure;</text> </paragraph> <paragraph num="(3)"> <text>Whether supervision is required for specimen and sample processing, forensic analysis performance, or result reporting; and</text> </paragraph> <paragraph num="(4)"> <text>If review by a technical leader or director is required before reporting a forensic analysis result; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Have the authority to initiate, suspend, and resume forensic analysis operations for:</text> <paragraph num="(1)"> <text>The laboratory; or</text> </paragraph> <paragraph num="(2)"> <text>An individual analyst or examiner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Quality Assurance Manager — Requirements."> <paragraph num="A."> <text>A director of a forensic laboratory shall designate a qualified individual as a quality assurance manager to be responsible for coordinating the activities required to ensure quality forensic analysis services.</text> </paragraph> <paragraph num="B."> <text>A quality assurance manager may be employed full-time or part-time as appropriate for the scope of forensic analysis services offered or performed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Quality Assurance Manager — Qualifications."> <text>A quality assurance manager of a forensic laboratory shall:</text> <paragraph num="A."> <text>Hold an earned baccalaureate or advanced degree from an accredited institution in:</text> <paragraph num="(1)"> <text>Forensic science;</text> </paragraph> <paragraph num="(2)"> <text>A natural science such as:</text> <paragraph num="(a)"> <text>Chemistry;</text> </paragraph> <paragraph num="(b)"> <text>Physics; or</text> </paragraph> <paragraph num="(c)"> <text>Biology; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A subspecialty of a natural science such as:</text> <paragraph num="(a)"> <text>Organic chemistry;</text> </paragraph> <paragraph num="(b)"> <text>Biochemistry; or</text> </paragraph> <paragraph num="(c)"> <text>Molecular biology; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Complete a training program as determined by the laboratory director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Assurance Manager — Duties and Responsibilities."> <paragraph num="A."> <text>Under the authority of the director, and operating independently of casework, a quality assurance manager shall be responsible for:</text> <paragraph num="(1)"> <text>Establishing:</text> <paragraph num="(a)"> <text>A comprehensive quality assessment system that includes quality control and quality assessment programs that cover the forensic analyses performed; and</text> </paragraph> <paragraph num="(b)"> <text>Parameters for necessary levels of performance for forensic analyses;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The overall maintenance and operation of the laboratory’s quality assurance program; and</text> </paragraph> <paragraph num="(3)"> <text>Maintaining pertinent documentation and records of quality assurance activities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The quality assurance manager shall:</text> <paragraph num="(1)"> <text>Oversee the:</text> <paragraph num="(a)"> <text>Participation and usage of an approved proficiency test provider commensurate with the licensed forensic analysis services;</text> </paragraph> <paragraph num="(b)"> <text>Administration of proficiency testing; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of proficiency test results;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain the forensic laboratory’s quality assurance:</text> <paragraph num="(a)"> <text>Program; and</text> </paragraph> <paragraph num="(b)"> <text>Program manual;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Evaluate instrument records for:</text> <paragraph num="(a)"> <text>Calibration;</text> </paragraph> <paragraph num="(b)"> <text>Validation; and</text> </paragraph> <paragraph num="(c)"> <text>Maintenance;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Review:</text> <paragraph num="(a)"> <text>Standard operating procedures;</text> </paragraph> <paragraph num="(b)"> <text>Internal audit records;</text> </paragraph> <paragraph num="(c)"> <text>Training records;</text> </paragraph> <paragraph num="(d)"> <text>Competency records;</text> </paragraph> <paragraph num="(e)"> <text>Proficiency tests;</text> </paragraph> <paragraph num="(f)"> <text>Management reviews; and</text> </paragraph> <paragraph num="(g)"> <text>Quality assurance documentation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Ensure all methods, including new methods and modifications to current methods, are validated;</text> </paragraph> <paragraph num="(6)"> <text>Select, train, and evaluate internal auditors;</text> </paragraph> <paragraph num="(7)"> <text>Investigate technical problems;</text> </paragraph> <paragraph num="(8)"> <text>Propose corrective or remedial actions;</text> </paragraph> <paragraph num="(9)"> <text>Verify that corrective or remedial actions:</text> <paragraph num="(a)"> <text>Are implemented; and</text> </paragraph> <paragraph num="(b)"> <text>Correct the identified problem;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Assess the adequacy of record review activities, including but not limited to:</text> <paragraph num="(a)"> <text>Reports; and</text> </paragraph> <paragraph num="(b)"> <text>Case records;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Document all corrective actions taken when forensic analysis systems and procedures deviate from the forensic laboratory’s established performance specifications; and</text> </paragraph> <paragraph num="(12)"> <text>Maintain records that demonstrate that proficiency testing samples are analyzed in the same manner as any other evidentiary specimen or sample received by the forensic laboratory for forensic analysis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Technical Leader — Requirements."> <paragraph num="A."> <text>If a licensee performs or offers to perform forensic analyses in the discipline of Biology-DNA analysis, a forensic laboratory shall have a technical leader who:</text> <paragraph num="(1)"> <text>Meets the qualifications set forth in this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Is responsible for the technical and scientific oversight of the section or unit in a forensic laboratory that performs forensic analyses for DNA.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Based on the scope of forensic analysis services, a licensee may employ one or more technical leaders who:</text> <paragraph num="(1)"> <text>Meet the qualifications of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Are responsible for the technical and scientific oversight of:</text> <paragraph num="(a)"> <text>The forensic laboratory; or</text> </paragraph> <paragraph num="(b)"> <text>A specific section or forensic science discipline in a forensic laboratory.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A technical leader:</text> <paragraph num="(1)"> <text>Is not required to be on-site in the forensic laboratory at all times forensic analyses are performed; and</text> </paragraph> <paragraph num="(2)"> <text>Shall be:</text> <paragraph num="(a)"> <text>Available to forensic laboratory employees as needed to provide technical and scientific oversight and assistance; and</text> </paragraph> <paragraph num="(b)"> <text>Accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Technical Leader — Qualifications."> <paragraph num="A."> <text>General. Except for the discipline of Biology-DNA analysis, a technical leader in a discipline or subdiscipline of a forensic laboratory shall:</text> <paragraph num="(1)"> <text>Hold an earned baccalaureate or advanced degree from an accredited institution in:</text> <paragraph num="(a)"> <text>Forensic science;</text> </paragraph> <paragraph num="(b)"> <text>A natural science such as:</text> <paragraph num="(i)"> <text>Chemistry;</text> </paragraph> <paragraph num="(ii)"> <text>Physics; or</text> </paragraph> <paragraph num="(iii)"> <text>Biology; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A subspecialty of a natural science such as:</text> <paragraph num="(i)"> <text>Organic chemistry;</text> </paragraph> <paragraph num="(ii)"> <text>Biochemistry; or</text> </paragraph> <paragraph num="(iii)"> <text>Molecular biology; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have documented post-degree experience in the forensic discipline or subdiscipline in which the individual will be a technical leader, as follows:</text> <paragraph num="(a)"> <text>4 years with a baccalaureate degree;</text> </paragraph> <paragraph num="(b)"> <text>3 years with a master’s degree; or</text> </paragraph> <paragraph num="(c)"> <text>2 years with a doctoral degree.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except for Biology-DNA analysis and forensic toxicology, a director may establish alternate qualifications for a technical leader in a discipline or subdiscipline of a forensic laboratory if the individual:</text> <paragraph num="(1)"> <text>Has 9 or more years of documented experience in the forensic discipline or subdiscipline in which the individual will be a technical leader; and</text> </paragraph> <paragraph num="(2)"> <text>Is able to demonstrate competency under the laboratory’s competency procedures in the forensic discipline or subdiscipline in which the individual will be a technical leader.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Forensic Toxicology. In addition to the requirements set forth in §A of this regulation, a technical leader in the discipline of forensic toxicology shall meet the requirements of and be certified under COMAR 10.10.09.</text> </paragraph> <paragraph num="D."> <text>Forensic Biology—DNA Analysis. If a forensic laboratory performs or offers to perform tests in the discipline of forensic DNA analysis, the technical leader shall meet the employee qualifications for a technical leader and be authorized by the licensee to carry out the duties and responsibilities of a technical leader, as set forth in Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Technical Leader — Responsibilities."> <paragraph num="A."> <text>Authority. A licensee may authorize a technical leader to initiate, suspend, and resume a forensic analysis or forensic analyses operations for:</text> <paragraph num="(1)"> <text>The laboratory, if assigned to the technical leader;</text> </paragraph> <paragraph num="(2)"> <text>The forensic analysis section or unit of the laboratory assigned to the technical leader; or</text> </paragraph> <paragraph num="(3)"> <text>An individual in the technical leader’s assigned forensic analysis section or unit of the laboratory.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A technical leader shall be responsible for:</text> <paragraph num="(1)"> <text>Selection of the test method, in concert with the laboratory director, that is appropriate, depending on the type of evidence, for forensic use and for reporting forensic analysis results;</text> </paragraph> <paragraph num="(2)"> <text>Validation of each forensic analysis procedure performed;</text> </paragraph> <paragraph num="(3)"> <text>Establishing the forensic laboratory’s forensic analysis performance specifications, including:</text> <paragraph num="(a)"> <text>Precision;</text> </paragraph> <paragraph num="(b)"> <text>Accuracy; and</text> </paragraph> <paragraph num="(c)"> <text>Uncertainty of measurement, where applicable;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Maintaining instrument records for:</text> <paragraph num="(a)"> <text>Calibration;</text> </paragraph> <paragraph num="(b)"> <text>Validation; and</text> </paragraph> <paragraph num="(c)"> <text>Maintenance;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Ensuring that:</text> <paragraph num="(a)"> <text>The performance levels established in §B of this regulation are maintained throughout the entire forensic analysis process:</text> <paragraph num="(i)"> <text>From initial receipt of the sample or specimen;</text> </paragraph> <paragraph num="(ii)"> <text>Through testing and examination; and</text> </paragraph> <paragraph num="(iii)"> <text>Through reporting of the forensic analysis results; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Forensic analysis results are not reported until all corrective actions have been taken and the forensic analysis system is functioning properly;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Resolving technical problems and ensuring that remedial actions are taken whenever a forensic analysis procedure or system deviates from the forensic laboratory’s established performance specifications; and</text> </paragraph> <paragraph num="(7)"> <text>Re-evaluating employee performance, before reporting forensic analysis results, to include the use of a new test method or instrumentation when a forensic analysis method or instrumentation changes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Forensic Analysis Employees — Requirement."> <text>A licensee shall ensure:</text> <paragraph num="A."> <text>The forensic laboratory has at least one individual who meets the employee qualification requirements of this chapter, to perform the functions set forth in this chapter, for the type of forensic tests and examinations performed in the laboratory; and</text> </paragraph> <paragraph num="B."> <text>Technical reviews of case files and reports are conducted as determined by the Director or applicable standards.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Forensic Analysis Employees — Qualifications."> <paragraph num="A."> <text>Forensic Analysis Employees — Qualifications for Toxicology and Trace Evidence Disciplines.</text> <paragraph num="(1)"> <text>A forensic analyst working in toxicology or trace evidence disciplines of a forensic laboratory shall:</text> <paragraph num="(a)"> <text>Possess a baccalaureate or advanced degree in a natural science, forensic science, or a closely related field of science; and</text> </paragraph> <paragraph num="(b)"> <text>Have successfully completed a training program in forensic toxicology or forensic analysis of trace evidence, as determined by the laboratory director.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual whose degree is in a field other than a natural science, forensic science, or a closely related field, may meet the educational requirements, as determined by the director and technical leader, if the individual has:</text> <paragraph num="(a)"> <text>Successfully completed 12 or more semester or credit hours of course work in biology, physics, or chemistry; and</text> </paragraph> <paragraph num="(b)"> <text>Successfully completed a training program in forensic toxicology, or forensic analysis of trace evidence, as determined by the laboratory director.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Forensic Analysis Employees — Qualifications for Controlled Dangerous Substances. An individual performing forensic laboratory analyses for controlled dangerous substances shall meet the pertinent employee qualifications and certification requirements set forth in COMAR 10.10.09.</text> </paragraph> <paragraph num="C."> <text>Forensic Analysis Employees — Qualifications for Biology Discipline of Forensic Science.</text> <paragraph num="(1)"> <text>A forensic analyst working in the biology discipline of forensic science shall:</text> <paragraph num="(a)"> <text>Possess a baccalaureate or advanced degree in a natural science, forensic science, or a closely related field of science; and</text> </paragraph> <paragraph num="(b)"> <text>Have successfully completed a training program in the biology discipline of forensic science, as determined by the laboratory director.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual whose degree is in a field other than a natural science, forensic science, or a closely related field, may meet the educational requirements, as determined by the director and technical leader, if the individual has:</text> <paragraph num="(a)"> <text>Taken 12 or more semester or credit hours of course work in biology, physics, or chemistry; and</text> </paragraph> <paragraph num="(b)"> <text>At least 2 years of training in the category of forensic analysis performed for the identification and evaluation of evidence in criminal matters.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Forensic Analysis Employees — Qualifications for Forensic DNA Analysis. A forensic analyst working in the forensic science discipline of biology who performs a DNA analysis shall meet the FBI standards for performing DNA analysis, as set forth in the Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference.</text> </paragraph> <paragraph num="E."> <text>Forensic Analysis Employees — Qualifications for Firearms and Toolmarks Examinations. An individual employed by a licensee to perform examinations of firearms and toolmarks evidence shall:</text> <paragraph num="(1)"> <text>Possess a baccalaureate degree in:</text> <paragraph num="(a)"> <text>A biological or physical science;</text> </paragraph> <paragraph num="(b)"> <text>Criminal justice;</text> </paragraph> <paragraph num="(c)"> <text>Law enforcement; or</text> </paragraph> <paragraph num="(d)"> <text>A related field; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a training program, as determined by the laboratory director and technical leader, in the fields of:</text> <paragraph num="(a)"> <text>Firearms;</text> </paragraph> <paragraph num="(b)"> <text>Processing or examination of forensic evidence; and</text> </paragraph> <paragraph num="(c)"> <text>Laboratory testing of materials.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Forensic Analysis Employees — Qualifications for Latent Examinations. An individual who classifies fingerprints or other friction-ridge prints or performs impression examinations shall:</text> <paragraph num="(1)"> <text>Possess a high school diploma or equivalent; and</text> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a training program, as determined by the laboratory director and technical leader, including:</text> <paragraph num="(a)"> <text>1 year performing duties related to:</text> <paragraph num="(i)"> <text>Law enforcement activities; or</text> </paragraph> <paragraph num="(ii)"> <text>Forensic laboratory services; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>1 year performing:</text> <paragraph num="(i)"> <text>Fingerprint classification; or</text> </paragraph> <paragraph num="(ii)"> <text>Latent examinations.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Forensic Analysis Employees — Qualifications for Forensic Document Examiner. An individual employed by a licensee to examine questioned documents or to be a forensic document examiner shall:</text> <paragraph num="(1)"> <text>Possess a baccalaureate degree or advanced degree in a natural science, forensic science, or a closely related field of science;</text> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a formal training program in the field of forensic document examination, as determined by the laboratory director; and</text> </paragraph> <paragraph num="(3)"> <text>Have at least 1 year of experience performing forensic analyses for the identification and evaluation of evidence in criminal matters.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Forensic Analysis Employee Responsibilities — General."> <text>A licensee shall ensure that:</text> <paragraph num="A."> <text>A forensic analysis employee is responsible for:</text> <paragraph num="(1)"> <text>Specimen and sample processing;</text> </paragraph> <paragraph num="(2)"> <text>Performing forensic analyses; and</text> </paragraph> <paragraph num="(3)"> <text>Reporting forensic analysis results; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual performs only those forensic analyses that:</text> <paragraph num="(1)"> <text>Are authorized by the forensic laboratory director for the individual to perform; and</text> </paragraph> <paragraph num="(2)"> <text>Require a degree of skill commensurate with the individual's education, training, experience, and technical abilities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Forensic Analysis Employee Responsibilities — Specific."> <text>Regardless of the forensic analysis category, an individual who performs a forensic analysis shall:</text> <paragraph num="A."> <text>Follow the forensic laboratory's approved procedures for:</text> <paragraph num="(1)"> <text>Specimen and sample handling and processing;</text> </paragraph> <paragraph num="(2)"> <text>Performing the forensic analysis; and</text> </paragraph> <paragraph num="(3)"> <text>Reporting and maintaining records of forensic analysis results;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Adhere to the forensic laboratory's policies and procedures for:</text> <paragraph num="(1)"> <text>Quality control;</text> </paragraph> <paragraph num="(2)"> <text>Quality assurance; and</text> </paragraph> <paragraph num="(3)"> <text>Ethics and data integrity;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Document all activities related to:</text> <paragraph num="(1)"> <text>Quality assurance;</text> </paragraph> <paragraph num="(2)"> <text>Quality control;</text> </paragraph> <paragraph num="(3)"> <text>Ethics and data integrity;</text> </paragraph> <paragraph num="(4)"> <text>Calibration of forensic analysis:</text> <paragraph num="(a)"> <text>Equipment;</text> </paragraph> <paragraph num="(b)"> <text>Instruments; and</text> </paragraph> <paragraph num="(c)"> <text>Procedures; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Performance of maintenance and repair of forensic:</text> <paragraph num="(a)"> <text>Equipment; and</text> </paragraph> <paragraph num="(b)"> <text>Instruments;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Follow the forensic laboratory's established policies and procedures if forensic analysis systems are not within the established specifications for acceptable performance; and</text> </paragraph> <paragraph num="E."> <text>Be capable of:</text> <paragraph num="(1)"> <text>Identifying a problem that may adversely affect performance of a forensic analysis or reporting of a forensic analysis result; and</text> </paragraph> <paragraph num="(2)"> <text>Following the laboratory policy and procedure for addressing nonconforming testing.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective July 20, 2015 (42:14 Md. R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective July 20, 2015 (42:14 Md. R. 880)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17E amended effective July 20, 2015 (42:14 Md. R. 880)</annotation> </annotations> </chapter> <chapter num="07" heading="Sanctions"> <regulation prefix="Regulation" num=".01" heading="Sanctions — General."> <paragraph num="A."> <text>Authority and Types.</text> <paragraph num="(1)"> <text>The Secretary may impose one or more principal or alternative sanctions if a forensic laboratory or the laboratory’s director or other employees fail to meet the standards of this subtitle and Health–General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Principal Sanctions. The Secretary may impose the following principal sanctions:</text> <paragraph num="(a)"> <text>Denial of a license;</text> </paragraph> <paragraph num="(b)"> <text>Suspension of a license; or</text> </paragraph> <paragraph num="(c)"> <text>Revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Alternative Sanctions. Instead of or in conjunction with withdrawing a principal sanction, the Secretary may impose one or more of the following alternative sanctions:</text> <paragraph num="(a)"> <text>A directed plan of correction;</text> </paragraph> <paragraph num="(b)"> <text>Limitation on forensic analyses; or</text> </paragraph> <paragraph num="(c)"> <text>Training and technical assistance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Reasons for Imposition. The Secretary may impose on a forensic laboratory one or more sanctions if the Secretary finds:</text> <paragraph num="(1)"> <text>A deficiency identified through:</text> <paragraph num="(a)"> <text>An on-site audit; or</text> </paragraph> <paragraph num="(b)"> <text>A review of materials submitted by a forensic laboratory that shows a problem with:</text> <paragraph num="(i)"> <text>Application data;</text> </paragraph> <paragraph num="(ii)"> <text>Employee qualification materials; or</text> </paragraph> <paragraph num="(iii)"> <text>Internal audits;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unsuccessful proficiency test performance;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrated incompetence, such as showing consistent or repetitive errors in:</text> <paragraph num="(a)"> <text>Operating forensic laboratory equipment; or</text> </paragraph> <paragraph num="(b)"> <text>Performing a forensic analysis;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>False statements made on an application, allegation of compliance, or other form submitted to the Department;</text> </paragraph> <paragraph num="(5)"> <text>Misrepresentation in obtaining a license or in operating a forensic laboratory;</text> </paragraph> <paragraph num="(6)"> <text>Submission of a sample or specimen by a forensic laboratory inside the State to another laboratory that does not possess a license or a waiver as set forth in this subtitle; or</text> </paragraph> <paragraph num="(7)"> <text>A violation of a law of the State pertaining to a forensic laboratory.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a forensic laboratory based on, but not limited to, the following:</text> <paragraph num="(1)"> <text>Whether a deficiency poses immediate jeopardy to public safety or individual rights;</text> </paragraph> <paragraph num="(2)"> <text>The nature, incidence, severity, and duration of the deficiency;</text> </paragraph> <paragraph num="(3)"> <text>Whether a deficiency has been identified repeatedly;</text> </paragraph> <paragraph num="(4)"> <text>Whether the Department can determine the laboratory’s compliance due to inaccurate record keeping or the licensee’s lack of documentation or laboratory records, including those required for quality assurance and quality control;</text> </paragraph> <paragraph num="(5)"> <text>Failure to make records available to the Department;</text> </paragraph> <paragraph num="(6)"> <text>The relationship of one deficiency or group of deficiencies to another deficiency;</text> </paragraph> <paragraph num="(7)"> <text>The overall compliance history of a forensic laboratory, including but not limited to any period of noncompliance that occurred between the Secretary’s determinations of compliance;</text> </paragraph> <paragraph num="(8)"> <text>The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and</text> </paragraph> <paragraph num="(9)"> <text>The progress a forensic laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Improper Referral of Proficiency Testing Samples. If the Department determines that a forensic laboratory has intentionally referred a proficiency testing sample to another laboratory for analysis, the Secretary:</text> <paragraph num="(1)"> <text>Shall revoke the forensic laboratory’s license for a period of 1 year; and</text> </paragraph> <paragraph num="(2)"> <text>May also impose one or more alternative sanctions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a forensic laboratory that has had the laboratory’s license revoked may not, within 1 year of the revocation, apply for a license for or own, operate, or direct a forensic laboratory.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Sanctions — Departmental Actions."> <paragraph num="A."> <text>Deficiency Posing Immediate Jeopardy.</text> <paragraph num="(1)"> <text>If a forensic laboratory’s deficiency poses immediate jeopardy to public safety or individual rights, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall:</text> <paragraph num="(a)"> <text>Require the forensic laboratory to take immediate action to remove the jeopardy; and</text> </paragraph> <paragraph num="(b)"> <text>Impose:</text> <paragraph num="(i)"> <text>A principal sanction after giving the forensic laboratory at least 24 hours’ notice; or</text> </paragraph> <paragraph num="(ii)"> <text>One or more alternative sanctions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Follow-up Actions. If the Department finds, in a follow-up audit of a forensic laboratory under an alternative sanction, that the forensic laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the forensic laboratory at least 24 hours’ notice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Deficiency Not Posing Immediate Jeopardy.</text> <paragraph num="(1)"> <text>If a forensic laboratory’s deficiency does not pose immediate jeopardy to personal or public safety, the Secretary may take one or more of the actions listed in §B(2)—(4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction.</text> </paragraph> <paragraph num="(3)"> <text>Unsuccessful Proficiency Testing Participation. If a forensic laboratory exhibits unsuccessful proficiency testing, as set forth in this subtitle, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction.</text> </paragraph> <paragraph num="(4)"> <text>Follow-up Actions. If the Department finds in a follow-up audit, that a forensic laboratory has not initiated a corrective action for a deficiency within 30 days after the deficiency was identified, the Secretary may:</text> <paragraph num="(a)"> <text>Impose, or continue if already imposed, one or more sanctions;</text> </paragraph> <paragraph num="(b)"> <text>Conduct one or more on-site audits to evaluate progress in the correction of a deficiency; and</text> </paragraph> <paragraph num="(c)"> <text>Conduct an additional follow-up on-site audit to determine whether all corrections have been made.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Duration of a Sanction. A sanction shall remain in force until:</text> <paragraph num="(1)"> <text>A forensic laboratory corrects the deficiency; or</text> </paragraph> <paragraph num="(2)"> <text>A forensic laboratory’s license is revoked.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Withdrawal of a Sanction.</text> <paragraph num="(1)"> <text>General. The Secretary may not withdraw a sanction until the Secretary verifies regulatory compliance with this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>Credible Allegation of Compliance. When a sanctioned forensic laboratory submits a credible allegation of compliance, the Secretary may determine compliance through one or more of the following ways:</text> <paragraph num="(a)"> <text>On the basis of the evidence submitted by the forensic laboratory in the allegation; or</text> </paragraph> <paragraph num="(b)"> <text>A follow-up audit to verify whether the forensic laboratory has achieved compliance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a forensic laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Principal Sanctions — Departmental Actions."> <paragraph num="A."> <text>Hearing Requirement.</text> <paragraph num="(1)"> <text>Except when the Secretary finds that a danger to public safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing:</text> <paragraph num="(a)"> <text>If a suspension or revocation of the licensee’s license takes effect;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the suspension or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>That the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Secretary finds a condition that imperatively requires emergency or immediate action to preserve public safety or individual rights, the Secretary shall inform the licensee in writing:</text> <paragraph num="(a)"> <text>When a suspension or revocation of the licensee’s license takes effect;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the suspension or revocation; and</text> </paragraph> <paragraph num="(c)"> <text>That the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, §10-226, Annotated Code of Maryland, after the suspension or revocation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice.</text> <paragraph num="(1)"> <text>Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the:</text> <paragraph num="(a)"> <text>Deficiency identified;</text> </paragraph> <paragraph num="(b)"> <text>Sanction proposed for imposition;</text> </paragraph> <paragraph num="(c)"> <text>Reason for the proposed sanction;</text> </paragraph> <paragraph num="(d)"> <text>Projected effective date and duration of the proposed sanction;</text> </paragraph> <paragraph num="(e)"> <text>Authority for the proposed sanction; and</text> </paragraph> <paragraph num="(f)"> <text>Time allowed for a forensic laboratory to respond to the notice.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Opportunity to Respond. During the time allowed and stated in the written notice, a forensic laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions.</text> </paragraph> <paragraph num="(3)"> <text>Notice Times.</text> <paragraph num="(a)"> <text>If a deficiency is found that imperatively requires emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of the sanction, unless conditions warrant immediate suspension.</text> </paragraph> <paragraph num="(b)"> <text>If a deficiency is found to warrant a principal sanction, but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>To preserve a right to a hearing, a licensee shall request a hearing within 10 days of the licensee’s receipt of the notice of the pending sanction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Enforcement Procedures — Proficiency Testing."> <paragraph num="A."> <text>Application. If a forensic laboratory’s performance in proficiency testing is unsatisfactory, as set forth in this subtitle, the Secretary may require the forensic laboratory to undertake the directed plan of correction of training the forensic laboratory employees or obtaining technical assistance, or both, in order to meet the proficiency testing requirements of this subtitle.</text> </paragraph> <paragraph num="B."> <text>Procedures. A forensic laboratory required to undertake training of employees or to obtain necessary technical assistance shall:</text> <paragraph num="(1)"> <text>Document the training or assistance, or both, using a form provided by the Department; and</text> </paragraph> <paragraph num="(2)"> <text>Submit the completed form to the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Departmental Action — Reporting Erroneous Test Results."> <paragraph num="A."> <text>If the Department determines that a licensee has reported an erroneous test result that threatens the safety or rights of an individual, the Secretary may order the licensee, within a specified period of time, to:</text> <paragraph num="(1)"> <text>Give prompt notice of the erroneous test result to:</text> <paragraph num="(a)"> <text>The person who ordered the forensic analysis be performed;</text> </paragraph> <paragraph num="(b)"> <text>Any other person to whom the forensic laboratory has previously sent a report that contained the erroneous test result;</text> </paragraph> <paragraph num="(c)"> <text>The Office of Public Defender or counsel of record; and</text> </paragraph> <paragraph num="(d)"> <text>The State’s Attorney;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide corrected reports to the persons notified in §A(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Maintain a duplicate copy of both the original report and the corrected report;</text> </paragraph> <paragraph num="(4)"> <text>Conduct a quality assessment of all phases of the testing or examination process to determine the cause of the erroneous forensic analysis test result;</text> </paragraph> <paragraph num="(5)"> <text>Take the necessary remedial or corrective action to prevent recurrence of the problem; and</text> </paragraph> <paragraph num="(6)"> <text>Take any additional measures necessary to reduce or eliminate the threat to public safety or individual rights.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Civil Money Penalty for Failure to Comply with Order.</text> <paragraph num="(1)"> <text>A forensic laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil money penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000.</text> </paragraph> <paragraph num="(2)"> <text>The Secretary may impose the civil money penalty instead of, or in addition to, any other sanction imposed under this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice and Hearing.</text> <paragraph num="(1)"> <text>Notice. Before the Secretary imposes a civil money penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to a licensee:</text> <paragraph num="(a)"> <text>Of the intent to impose a civil money penalty; and</text> </paragraph> <paragraph num="(b)"> <text>That the licensee has an opportunity for a hearing on the matter before the civil money penalty is imposed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Content. The Secretary shall give written notice to the licensee of the:</text> <paragraph num="(a)"> <text>Reason for the imposition of the civil money penalty;</text> </paragraph> <paragraph num="(b)"> <text>Amount of the civil money penalty;</text> </paragraph> <paragraph num="(c)"> <text>Effective date of the imposition of the civil money penalty;</text> </paragraph> <paragraph num="(d)"> <text>Time allowed for the licensee to respond to the notice; and</text> </paragraph> <paragraph num="(e)"> <text>Authority for imposing the civil money penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary’s intent to impose the civil money penalty.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil money penalty is appropriate, the Secretary shall consider the following factors in determining the amount of the penalty:</text> <paragraph num="(1)"> <text>The extent to which the licensee derived any financial or other benefit from reporting erroneous forensic analysis results;</text> </paragraph> <paragraph num="(2)"> <text>The willfulness on the part of the licensee to violate this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>The extent of actual or potential harm caused by the reporting of erroneous forensic analysis results;</text> </paragraph> <paragraph num="(4)"> <text>The cost of investigating and prosecuting the case against the licensee;</text> </paragraph> <paragraph num="(5)"> <text>The licensee’s history of previous failure to meet the standards of this subtitle; and</text> </paragraph> <paragraph num="(6)"> <text>The existence of mitigating factors.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 28, 2012 (39:10 Md. R. 660)</annotation> </annotations> </chapter> <chapter num="08" heading="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective January 19, 2004 (31:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151)</annotation> </annotations> </chapter> <chapter num="09" heading="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151)</annotation> </annotations> </chapter> <chapter num="10" heading="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, C amended effective January 19, 2004 (31:1 Md. R. 31)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151)</annotation> </annotations> </chapter> <chapter num="11" heading="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151)</annotation> </annotations> </chapter> </subtitle> <subtitle num="52" heading="Preventive Medicine"> <chapter num="01" heading="Opioid-Associated Disease Prevention and Outreach Programs"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Defines an opioid-associated disease prevention and outreach program; and</text> </paragraph> <paragraph num="B."> <text>Sets forth:</text> <paragraph num="(1)"> <text>The responsibilities of the Maryland Department of Health and local health departments in establishing opioid-associated disease prevention and outreach programs; and</text> </paragraph> <paragraph num="(2)"> <text>Requirements for:</text> <paragraph num="(a)"> <text>Monitoring and evaluating opioid-associated disease prevention and outreach programs; and</text> </paragraph> <paragraph num="(b)"> <text>Research conducted in collaboration with an opioid-associated disease prevention and outreach program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a local health department or community-based organization seeking to establish an opioid-associated disease prevention and outreach program.</text> </paragraph> <paragraph num="(2)"> <text>Body Fluid.</text> <paragraph num="(a)"> <text>“Body fluid” means any fluid containing visible blood, semen, or vaginal secretions.</text> </paragraph> <paragraph num="(b)"> <text>“Body fluid” does not include cerebrospinal fluid, synovial fluid, breast milk, amniotic fluid, saliva, stool, nasal secretions, sputum, tears, urine, or vomitus.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Community-based organization (CBO)” means a public or private organization that:</text> <paragraph num="(a)"> <text>Is representative of a community or significant segments of a community; and</text> </paragraph> <paragraph num="(b)"> <text>Provides educational, health, or social services to individuals in the community.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Harm reduction education” means education on practical strategies:</text> <paragraph num="(a)"> <text>To reduce negative consequences associated with drug use; and</text> </paragraph> <paragraph num="(b)"> <text>That reflect specific individual and community needs.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“HIV” means the human immunodeficiency virus that causes acquired immune deficiency syndrome (AIDS).</text> </paragraph> <paragraph num="(7)"> <text>“Infection control” means infection prevention and control measures that ensure the protection of individuals who are vulnerable to acquiring an infection both in the general community and while receiving health care services in a range of settings.</text> </paragraph> <paragraph num="(8)"> <text>“Injection supplies” means materials used to inject drugs including, but not limited to:</text> <paragraph num="(a)"> <text>Cookers;</text> </paragraph> <paragraph num="(b)"> <text>Water; and</text> </paragraph> <paragraph num="(c)"> <text>Cotton.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Naloxone” means an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression.</text> </paragraph> <paragraph num="(10)"> <text>“OADPO program” means an opioid-associated disease prevention and outreach program established by a local health department or community-based organization that provides services including:</text> <paragraph num="(a)"> <text>Dissemination of hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis;</text> </paragraph> <paragraph num="(b)"> <text>Overdose prevention education; and</text> </paragraph> <paragraph num="(c)"> <text>Harm reduction education.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Participant” means an individual who has registered with an OADPO program.</text> </paragraph> <paragraph num="(12)"> <text>“Sexually transmitted infection (STI)” means an infection passed from one person to another person through sexual contact.</text> </paragraph> <paragraph num="(13)"> <text>“Viral hepatitis” means inflammation of the liver caused by the hepatitis A, B, C, D, and E viruses.</text> </paragraph> <paragraph num="(14)"> <text>“Wound care” means treatment of the symptoms of infections that may result from using drugs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Program Establishment."> <paragraph num="A."> <text>Effective October 1, 2016, a local health department or CBO may establish an OADPO program with approval from the:</text> <paragraph num="(1)"> <text>Department; and</text> </paragraph> <paragraph num="(2)"> <text>Local health officer of the county in which OADPO program operations are proposed.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When proposing an OADPO program, a local health department may collaborate with:</text> <paragraph num="(1)"> <text>A CBO; or</text> </paragraph> <paragraph num="(2)"> <text>Another local health department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A CBO may operate an OADPO program in multiple counties if approved by the local health officer in each county where the OADPO program proposes to operate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Process."> <paragraph num="A."> <text>An applicant:</text> <paragraph num="(1)"> <text>Shall submit an application to establish an OADPO program to the Department that includes:</text> <paragraph num="(a)"> <text>Responses to all applicable questions; and</text> </paragraph> <paragraph num="(b)"> <text>Any supporting documentation indicated on the application;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May voluntarily withdraw an application at any time; and</text> </paragraph> <paragraph num="(3)"> <text>May submit a new application at any time.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Distribute the application to establish an OADPO program to the local health officer in each jurisdiction where the OADPO program proposes to operate;</text> </paragraph> <paragraph num="(2)"> <text>Request additional information or changes to the application if necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Respond in writing to the applicant within 60 calendar days indicating the disposition of the application and explanation of the decision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department and the local health officer in each jurisdiction where the OADPO program proposes to operate shall jointly:</text> <paragraph num="(1)"> <text>Review the application; and</text> </paragraph> <paragraph num="(2)"> <text>Either:</text> <paragraph num="(a)"> <text>Approve the application if the:</text> <paragraph num="(i)"> <text>Application is complete; and</text> </paragraph> <paragraph num="(ii)"> <text>OADPO program meets the requirements of Regulations .05 and .06 of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Disapprove the application if the:</text> <paragraph num="(i)"> <text>Application does not provide sufficient information or documentation on the OADPO program; or</text> </paragraph> <paragraph num="(ii)"> <text>OADPO program does not meet the requirements of Regulations .05 and .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant whose application is disapproved may appeal the decision to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of disapproval.</text> </paragraph> <paragraph num="E."> <text>If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:</text> <paragraph num="(1)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(2)"> <text>Respond in writing to the applicant:</text> <paragraph num="(a)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(b)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Program Design and Operation."> <paragraph num="A."> <text>The CBO or local health department approved to operate an OADPO program:</text> <paragraph num="(1)"> <text>Shall provide protocols for the safety and security of OADPO program locations, equipment, and staff in accordance with Regulation .06 of this chapter that:</text> <paragraph num="(a)"> <text>Control the dissemination of hypodermic needles and syringes; and</text> </paragraph> <paragraph num="(b)"> <text>Allow for a full accounting of the number of hypodermic needles and syringes managed by the program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall offer participants:</text> <paragraph num="(a)"> <text>Overdose prevention education;</text> </paragraph> <paragraph num="(b)"> <text>Access to or a referral to obtain naloxone; and</text> </paragraph> <paragraph num="(c)"> <text>Harm reduction education;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Shall ensure that all OADPO program staff have:</text> <paragraph num="(a)"> <text>Appropriate levels of expertise in working with individuals who inject drugs;</text> </paragraph> <paragraph num="(b)"> <text>Knowledge of harm reduction strategies; and</text> </paragraph> <paragraph num="(c)"> <text>Skills in implementing harm reduction strategies;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall ensure that all OADPO program staff receive training approved by the Department to work with injection drug users and to provide referrals to:</text> <paragraph num="(a)"> <text>Community services;</text> </paragraph> <paragraph num="(b)"> <text>Counseling; and</text> </paragraph> <paragraph num="(c)"> <text>Preventative education;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Shall ensure that all OADPO program staff demonstrate sensitivity to participant differences including:</text> <paragraph num="(a)"> <text>Cultural;</text> </paragraph> <paragraph num="(b)"> <text>Behavioral; and</text> </paragraph> <paragraph num="(c)"> <text>Values;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Shall ensure that information collected to identify OADPO program participants is kept confidential according to:</text> <paragraph num="(a)"> <text>Health-General Article, §24-906(b), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>42 CFR Part 2;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Shall ensure that there is a method of identification and authorization for OADPO program staff members who have access to:</text> <paragraph num="(a)"> <text>Hypodermic needles;</text> </paragraph> <paragraph num="(b)"> <text>Syringes; and</text> </paragraph> <paragraph num="(c)"> <text>OADPO program records;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Shall develop and provide a protocol for linking participants to:</text> <paragraph num="(a)"> <text>Substance abuse treatment services;</text> </paragraph> <paragraph num="(b)"> <text>Testing for:</text> <paragraph num="(i)"> <text>HIV;</text> </paragraph> <paragraph num="(ii)"> <text>Viral hepatitis; and</text> </paragraph> <paragraph num="(iii)"> <text>STIs;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Reproductive health services;</text> </paragraph> <paragraph num="(d)"> <text>Wound care; and</text> </paragraph> <paragraph num="(e)"> <text>Naloxone;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Shall disseminate hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis at no cost to participants, including but not limited to:</text> <paragraph num="(a)"> <text>Injection supplies; and</text> </paragraph> <paragraph num="(b)"> <text>Safer sex supplies; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>May not discriminate against participants based on factors including but not limited to:</text> <paragraph num="(a)"> <text>Culture;</text> </paragraph> <paragraph num="(b)"> <text>Language;</text> </paragraph> <paragraph num="(c)"> <text>Ability;</text> </paragraph> <paragraph num="(d)"> <text>Socioeconomic status;</text> </paragraph> <paragraph num="(e)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(f)"> <text>Gender identity;</text> </paragraph> <paragraph num="(g)"> <text>Age;</text> </paragraph> <paragraph num="(h)"> <text>Religion;</text> </paragraph> <paragraph num="(i)"> <text>Race; and</text> </paragraph> <paragraph num="(j)"> <text>Ethnicity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Identification Card. OADPO program staff shall:</text> <paragraph num="(1)"> <text>Give each participant an identification card that includes the participant’s OADPO program identification number;</text> </paragraph> <paragraph num="(2)"> <text>Advise participants to carry the identification card with them at all times; and</text> </paragraph> <paragraph num="(3)"> <text>If the identification card is lost by a participant, re-issue an identification card to the participant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The CBO or local health department approved to operate an OADPO program may offer other services to OADPO program participants, including:</text> <paragraph num="(1)"> <text>Testing for:</text> <paragraph num="(a)"> <text>HIV;</text> </paragraph> <paragraph num="(b)"> <text>Viral hepatitis; and</text> </paragraph> <paragraph num="(c)"> <text>STIs;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Wound care;</text> </paragraph> <paragraph num="(3)"> <text>Reproductive health services; and</text> </paragraph> <paragraph num="(4)"> <text>Substance abuse counseling, treatment, and recovery services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Program Security."> <paragraph num="A."> <text>An OADPO program shall implement protocols for the safety and security of program locations, equipment, and staff.</text> </paragraph> <paragraph num="B."> <text>OADPO program staff shall:</text> <paragraph num="(1)"> <text>Wear suitable clothing, including closed footwear, at all times;</text> </paragraph> <paragraph num="(2)"> <text>Treat all body fluids as potentially infectious and follow infection control protocols at all times including:</text> <paragraph num="(a)"> <text>Use of barriers including gloves;</text> </paragraph> <paragraph num="(b)"> <text>Immediate washing of hands and other skin surfaces after contact with body fluids; and</text> </paragraph> <paragraph num="(c)"> <text>Careful handling and disposal of sharp instruments during and after use;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When working off-site, have access to a communications system that allows staff to stay in contact with:</text> <paragraph num="(a)"> <text>Other staff; and</text> </paragraph> <paragraph num="(b)"> <text>Emergency support;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Obtain consent of the owner or occupier of private property to enter the property to dispense or collect syringes or hypodermic needles; and</text> </paragraph> <paragraph num="(5)"> <text>Transport biohazardous waste to the disposal facility using a method that does not put any individuals at risk.</text> </paragraph> </paragraph> <paragraph num="C."> <text>OADPO programs shall:</text> <paragraph num="(1)"> <text>Have a critical incident procedure that outlines processes and responsibilities of program staff for managing incidents including:</text> <paragraph num="(a)"> <text>Participant aggression;</text> </paragraph> <paragraph num="(b)"> <text>Threats of violence; and</text> </paragraph> <paragraph num="(c)"> <text>Other hazardous situations;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have available the following safety equipment during program operations:</text> <paragraph num="(a)"> <text>Puncture resistant utility gloves;</text> </paragraph> <paragraph num="(b)"> <text>Bleach; and</text> </paragraph> <paragraph num="(c)"> <text>Forceps or tongs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have facilities that:</text> <paragraph num="(a)"> <text>Have adequate lighting; and</text> </paragraph> <paragraph num="(b)"> <text>Are free from clutter; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have a:</text> <paragraph num="(a)"> <text>Contract with a licensed biohazardous waste disposal facility to receive biohazardous waste; or</text> </paragraph> <paragraph num="(b)"> <text>Written agreement that authorizes the OADPO program to drop off used syringes contained in a locked sharps container for safe disposal with a:</text> <paragraph num="(i)"> <text>Hospital;</text> </paragraph> <paragraph num="(ii)"> <text>Doctor’s office;</text> </paragraph> <paragraph num="(iii)"> <text>Pharmacy;</text> </paragraph> <paragraph num="(iv)"> <text>Medical testing facility; or</text> </paragraph> <paragraph num="(v)"> <text>Other facility that already receives and safely disposes of hazardous waste.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>To prevent needlestick injuries, OADPO program participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:</text> <paragraph num="(1)"> <text>Receive education on safety protocols for:</text> <paragraph num="(a)"> <text>Carrying and handling:</text> <paragraph num="(i)"> <text>Syringes;</text> </paragraph> <paragraph num="(ii)"> <text>Hypodermic needles; and</text> </paragraph> <paragraph num="(iii)"> <text>Other sharps;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The transport and disposal of biohazardous waste; and</text> </paragraph> <paragraph num="(c)"> <text>Infection control;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Refrain from touching, without safety equipment, used:</text> <paragraph num="(a)"> <text>Hypodermic needles;</text> </paragraph> <paragraph num="(b)"> <text>Syringes; and</text> </paragraph> <paragraph num="(c)"> <text>Injection supplies; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be encouraged to wear clothing at all times that provides protection against needlestick injuries including:</text> <paragraph num="(a)"> <text>Long pants; and</text> </paragraph> <paragraph num="(b)"> <text>Long-sleeved shirts.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Use of Sharps Containers.</text> <paragraph num="(1)"> <text>Used hypodermic needles, syringes, and injection supplies collected by the program from participants shall be placed in sharps containers.</text> </paragraph> <paragraph num="(2)"> <text>Sharps containers:</text> <paragraph num="(a)"> <text>Shall be leak proof;</text> </paragraph> <paragraph num="(b)"> <text>Shall be rigid;</text> </paragraph> <paragraph num="(c)"> <text>Shall be puncture resistant;</text> </paragraph> <paragraph num="(d)"> <text>Shall be labeled as containing sharps;</text> </paragraph> <paragraph num="(e)"> <text>Shall be placed on a level, secure surface that is a safe distance between participants and staff or volunteers during syringe exchange transactions; and</text> </paragraph> <paragraph num="(f)"> <text>May not be more than 75 percent full.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participants shall:</text> <paragraph num="(a)"> <text>Place into the sharps container all used:</text> <paragraph num="(i)"> <text>Hypodermic needles;</text> </paragraph> <paragraph num="(ii)"> <text>Syringes; and</text> </paragraph> <paragraph num="(iii)"> <text>Injection supplies;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When possible, retrieve supplies that fall outside of the sharps container, including:</text> <paragraph num="(i)"> <text>Hypodermic needles;</text> </paragraph> <paragraph num="(ii)"> <text>Syringes; and</text> </paragraph> <paragraph num="(iii)"> <text>Injection supplies; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>When possible, cover supplies used by the participant including:</text> <paragraph num="(i)"> <text>Hypodermic needles;</text> </paragraph> <paragraph num="(ii)"> <text>Syringes; and</text> </paragraph> <paragraph num="(iii)"> <text>Injection supplies.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Needlestick Injuries.</text> <paragraph num="(1)"> <text>OADPO programs shall implement protocols for handling needlestick injuries.</text> </paragraph> <paragraph num="(2)"> <text>OADPO programs shall designate at least one needlestick manager who shall:</text> <paragraph num="(a)"> <text>Assist injured individuals present at the facility including:</text> <paragraph num="(i)"> <text>Participants;</text> </paragraph> <paragraph num="(ii)"> <text>Staff;</text> </paragraph> <paragraph num="(iii)"> <text>Volunteers; and</text> </paragraph> <paragraph num="(iv)"> <text>Any other individuals present in an occupational capacity;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Follow established procedures for accident or incident reporting; and</text> </paragraph> <paragraph num="(c)"> <text>Immediately notify the ranking supervisor of any needlestick injuries.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:</text> <paragraph num="(a)"> <text>Report a needlestick injury to the on-site needlestick manager immediately; and</text> </paragraph> <paragraph num="(b)"> <text>Visit the emergency room or a private physician within 24 hours of the occurrence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Post-Exposure Management. OADPO programs shall implement protocols for post-exposure management including:</text> <paragraph num="(1)"> <text>Testing; and</text> </paragraph> <paragraph num="(2)"> <text>Post-exposure prophylaxis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Monitoring and Evaluation."> <paragraph num="A."> <text>OADPO programs shall:</text> <paragraph num="(1)"> <text>Submit all data for each reporting period on a quarterly basis as required by the Department, including:</text> <paragraph num="(a)"> <text>The number of:</text> <paragraph num="(i)"> <text>Participants served by the OADPO program;</text> </paragraph> <paragraph num="(ii)"> <text>New participants registered by the OADPO program;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Demographic data of participants served by the OADPO program, including:</text> <paragraph num="(i)"> <text>Age;</text> </paragraph> <paragraph num="(ii)"> <text>Gender identity;</text> </paragraph> <paragraph num="(iii)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(iv)"> <text>Race;</text> </paragraph> <paragraph num="(v)"> <text>Ethnicity;</text> </paragraph> <paragraph num="(vi)"> <text>Zip code; and</text> </paragraph> <paragraph num="(vii)"> <text>Types of drugs the participant reports using;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The number of hypodermic needles and syringes distributed and collected;</text> </paragraph> <paragraph num="(d)"> <text>Each location where hypodermic needles and syringes were distributed; and</text> </paragraph> <paragraph num="(e)"> <text>The number of referrals to services provided to participants listed in Health-General Article, §24-903(A)(6), Annotated Code of Maryland, and Regulation .05A(4) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Collect data using methods that will not deter participants from utilizing OADPO program services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may conduct site visits to monitor and evaluate an OADPO program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Research."> <paragraph num="A."> <text>An individual researcher or institution shall apply for and receive approval from the Department before starting research in collaboration with an OADPO program.</text> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review each request; and</text> </paragraph> <paragraph num="(2)"> <text>Approve or disapprove the proposed research based on whether the proposed research:</text> <paragraph num="(a)"> <text>Advances scientific knowledge or practice related to opioid-associated disease prevention and outreach;</text> </paragraph> <paragraph num="(b)"> <text>Has approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;</text> </paragraph> <paragraph num="(c)"> <text>Has one or more investigators who have training and experience with the approaches and methods;</text> </paragraph> <paragraph num="(d)"> <text>Will impede or interfere with the operations of the OADPO program;</text> </paragraph> <paragraph num="(e)"> <text>Is approved by the Department’s Institutional Review Board to ensure that the research will be conducted according to established ethical guidelines for research in the field of opioid-associated disease prevention and outreach; and</text> </paragraph> <paragraph num="(f)"> <text>Will keep any data used for the research confidential as required by:</text> <paragraph num="(i)"> <text>Health-General Article, §24-906(B), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>42 U.S.C. §290dd-2; and</text> </paragraph> <paragraph num="(iii)"> <text>42 CFR Part 2.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Revocation of Approval and Appeals."> <paragraph num="A."> <text>The Department and the local health officer may revoke the approval of an OADPO program if the OADPO program does not:</text> <paragraph num="(1)"> <text>Meet the requirements of Health-General Article, Title 24, Subtitle 9, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Operate in accordance with the requirements of Regulations .05 and .06 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Notify the OADPO program in writing of the revocation of approval; and</text> </paragraph> <paragraph num="(2)"> <text>Provide an explanation of the decision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An OADPO program may appeal the decision to revoke approval to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of revocation of approval.</text> </paragraph> <paragraph num="D."> <text>If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:</text> <paragraph num="(1)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(2)"> <text>Respond in writing to the applicant:</text> <paragraph num="(a)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(b)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§24-901—24-909, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 24, 2017 (44:8 Md. R. 404)</annotation> </annotations> </chapter> <chapter num="02" heading="High Blood Pressure Control Services"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 8, 1985 (12:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, B amended effective November 20, 1994 (21:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective October 5, 2020 (47:20 Md. R. 875)</annotation> </annotations> </chapter> <chapter num="03" heading="Health Education — General Regulations"> <regulation prefix="Regulation" num=".01" heading="Health Education Services Regulations."> <paragraph num="A."> <text>Type of Service to Be Provided. Services to be provided are health education services of a general nature for purposes of informing the public about various health issues, promoting health enhancing behaviors, and organizing groups to promote the health enhancing activities of others or to achieve societal and environmental changes conducive to health. These services include but are not limited to the following:</text> <paragraph num="(1)"> <text>Planning, conducting, and evaluating a media campaign or a component of a media campaign;</text> </paragraph> <paragraph num="(2)"> <text>Planning, conducting, and evaluating an employee or community intervention for a specified behavior change;</text> </paragraph> <paragraph num="(3)"> <text>Training health professionals to provide effective education to their clients;</text> </paragraph> <paragraph num="(4)"> <text>Distributing existing or newly developed health-related educational materials and resources;</text> </paragraph> <paragraph num="(5)"> <text>Organizing and leading a group to find goals and strategies to achieve a health end;</text> </paragraph> <paragraph num="(6)"> <text>Implementing population-based health education programs using evidence-based methods and strategies;</text> </paragraph> <paragraph num="(7)"> <text>Assessing and analyzing community needs and assets;</text> </paragraph> <paragraph num="(8)"> <text>Accessing, interpreting, and disseminating qualitative and quantitative data; and</text> </paragraph> <paragraph num="(9)"> <text>Planning, conducting, and evaluating health promotion and education interventions and initiatives.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Client Eligibility Standards. All permanent residents of Maryland are eligible to receive services subject to the funding available and limited by the jurisdiction or jurisdictions and target populations specified in a request for proposal.</text> </paragraph> <paragraph num="C."> <text>Licensing or Certification Requirements of Professional Service Providers and Facilities as Applicable.</text> <paragraph num="(1)"> <text>All organizations, public and private, which are permitted to engage in business in Maryland may be contractors for health education services.</text> </paragraph> <paragraph num="(2)"> <text>If candidates seeking health educator positions in State service have similar qualifications, the Maryland Department of Health shall give a hiring preference to those candidates who have Certified Health Education Specialist (CHES) credentials issued by the National Commission for Health Education Credentialing, Inc.</text> </paragraph> <paragraph num="(3)"> <text>Vendor requirements for specific programs, if any, will be specified in a request for proposal.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and 2-105(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 8, 1985 (12:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, C amended effective June 25, 2012 (39:12 Md. R. 745)</annotation> </annotations> </chapter> <chapter num="04" heading="Condom Vending Machines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to a condom offered for sale or sold by means of a vending machine or other automatic device, and to a vending machine or other automatic device used for selling condoms.</text> </paragraph> <paragraph num="B."> <text>This chapter does not apply to a condom sold person-to-person in a business establishment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Approved Condoms."> <text>A condom that is approved by the U.S. Food and Drug Administration (FDA) as a medical device may be sold or offered for sale by means of a vending machine or other automatic device.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Labeling of Product."> <text>A novelty device which resembles a condom but is not intended for prevention of sexually transmitted diseases or pregnancy and is not FDA approved as a medical device shall be clearly marked: “This item is not intended for prevention of sexually transmitted diseases or pregnancy.”</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Labeling of Vending Machine."> <text>A vending machine or other automatic device used for selling condoms shall be labeled with the name, address, and telephone number of the person or firm responsible for stocking the machine with condoms.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104 and 18-335; Criminal Law Article, §10-104; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 26, 1990 (17:23 Md. R. 2733)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 7, 2002 (28:26 Md. R. 2274)</annotation> </annotations> </chapter> <chapter num="05" heading="Pertussis and Pertussis Vaccine"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="B."> <text>“Health care provider” means any licensed health care professional, organization, or institution, whether public or private, under whose authority pertussis vaccine is administered.</text> </paragraph> <paragraph num="C."> <text>“Major adverse reaction” means any:</text> <paragraph num="(1)"> <text>Serious illness, disability, or impairment of mental, emotional, behavioral, or physical functioning or development, the first manifestation of which appears within 7 days after the date of administration of pertussis vaccine and for which there is reasonable scientific or medical evidence pertussis vaccine causes, or significantly contributes to, the effect; and</text> </paragraph> <paragraph num="(2)"> <text>Other reaction which the Department, after consultation with the Medical and Chirurgical Faculty of Maryland, determines is a basis for not continuing with pertussis vaccine administration.</text> </paragraph> </paragraph> <paragraph num="D."> <text>“Patient” means the individual to whom pertussis vaccine is being administered.</text> </paragraph> <paragraph num="E."> <text>“Pertussis vaccine” means any vaccine that contains materials intended to prevent the occurrence of pertussis, whether the materials are administered separately or in conjunction with other materials intended to prevent the occurrence of other diseases.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Health Care Providers."> <paragraph num="A."> <text>Before the administration of pertussis vaccine, the health care provider shall provide to the patient's parent or guardian written information addressing:</text> <paragraph num="(1)"> <text>The frequency, severity, and potential long-term effects of pertussis;</text> </paragraph> <paragraph num="(2)"> <text>Possible adverse reactions to pertussis vaccine, which, if they occur, should be brought to the immediate attention of the health care provider;</text> </paragraph> <paragraph num="(3)"> <text>A form that lists symptoms of possible pertussis vaccine adverse reactions to be monitored and which contains places where information can be recorded to assist in reporting to the health care provider, local health officer, and the Department;</text> </paragraph> <paragraph num="(4)"> <text>Measures parents should take to reduce the risk of, or to respond to, any major adverse reaction to pertussis vaccine;</text> </paragraph> <paragraph num="(5)"> <text>Early warning signs or symptoms to which parents should be alert as possible precursors to a major adverse reaction to pertussis vaccine;</text> </paragraph> <paragraph num="(6)"> <text>When and to whom parents should report any major adverse reactions to pertussis vaccine;</text> </paragraph> <paragraph num="(7)"> <text>A summary of the immunization requirements adopted under Education Article, §7-402(a), Annotated Code of Maryland, including those related to pertussis vaccine;</text> </paragraph> <paragraph num="(8)"> <text>The circumstances under which pertussis vaccine may not be administered;</text> </paragraph> <paragraph num="(9)"> <text>The circumstances under which administration of pertussis vaccine shall be delayed; and</text> </paragraph> <paragraph num="(10)"> <text>Categories of potential recipients who are significantly more vulnerable to major adverse reactions to pertussis vaccine than is the general population.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before the administration of pertussis vaccine, the health care provider shall, by appropriate inquiries, attempt to elicit the information necessary to determine, based on a physician's medical judgement whether:</text> <paragraph num="(1)"> <text>Pertussis vaccine should not be administered to the patient;</text> </paragraph> <paragraph num="(2)"> <text>Administration of pertussis vaccine should be delayed; or</text> </paragraph> <paragraph num="(3)"> <text>The risk to the potential recipient of the vaccine outweighs the benefits both to the potential recipient and to the public in administering the vaccine.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The circumstances under which the administration of pertussis vaccine shall be delayed or may not occur are established by the Immunization Practices Advisory Committee (ACIP) to the Public Health Service. The Department will notify all health care providers of these circumstances.</text> </paragraph> <paragraph num="D."> <text>A physician who determines, pursuant to §B, of this regulation, that the administration of the pertussis vaccine to a patient shall be delayed or may not occur shall submit to the local health officer the name, address, date of birth, and the basis for the determination for each patient.</text> </paragraph> <paragraph num="E."> <text>Pertussis vaccine should not be given if in the physician's medical judgment, taking into account any categories of potential recipients who are significantly more vulnerable to major adverse reactions than is the general population, as well as all other relevant information, the risk to the potential recipient outweighs the benefits both to the potential recipient and the public in administering the vaccine.</text> </paragraph> <paragraph num="F."> <text>At the time of administration of pertussis vaccine to a patient, the health care provider shall record in a permanent record to which the patient's parent or guardian shall have access upon request:</text> <paragraph num="(1)"> <text>The date each dose of pertussis vaccine is administered;</text> </paragraph> <paragraph num="(2)"> <text>The manufacturer and lot number of the vaccine used for each;</text> </paragraph> <paragraph num="(3)"> <text>Other identifying information on the vaccine used; and</text> </paragraph> <paragraph num="(4)"> <text>The name and title of the health care provider who authorized the vaccine to be administered and the one who administered it.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A health care provider who has administered the pertussis vaccine to a patient and who has been informed by the parent or guardian of the patient, or has reason to believe that the patient has had a major adverse reaction to pertussis vaccine, shall within 24 hours of receipt of that knowledge:</text> <paragraph num="(1)"> <text>Record to the extent of his knowledge all relevant information in the patient's permanent medical record; and</text> </paragraph> <paragraph num="(2)"> <text>Report information, including the manufacturer's name, date of administration, type and lot number of the vaccine, a brief description of the reaction, and other specified information on a morbidity report card, to the local health officer. These reports can also be made by telephone.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements of Local Health Officers."> <paragraph num="A."> <text>Upon receipt of notification of a major adverse reaction to a pertussis vaccine, the local health officer shall:</text> <paragraph num="(1)"> <text>Notify and forward the morbidity report card to the Department within 24 hours; and</text> </paragraph> <paragraph num="(2)"> <text>Assure that the necessary information to fill out a “Report of Adverse Event Following Immunization” is obtained.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At the time of completion, the report shall be submitted to the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements of the Department."> <paragraph num="A."> <text>Whenever a resident birth occurs, the Department shall promptly provide parents of the newborn child with information included in Regulation .02A(1)—(10) of this chapter.</text> </paragraph> <paragraph num="B."> <text>The Department shall prescribe the form and content of the information about immunizations provided to parents at times of birth and of administration of pertussis vaccine, according to Regulation .02A(1)—(10) of this chapter.</text> </paragraph> <paragraph num="C."> <text>Upon receipt of information regarding a major adverse reaction to a pertussis vaccine, the Department shall immediately notify the vaccine manufacturer of the following:</text> <paragraph num="(1)"> <text>Date of immunization;</text> </paragraph> <paragraph num="(2)"> <text>Lot number of vaccine; and</text> </paragraph> <paragraph num="(3)"> <text>Type of reaction.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department shall establish a system to collect data from local health officers, from public and private health care providers, and from parents, on the incidence of pertussis and major adverse reactions to pertussis vaccine. This system shall be organized so that periodic revisions and updates of information and guidelines may be made. In addition, the information collected shall be sufficient for any reports required by the Department on pertussis and major adverse reactions to pertussis vaccine.</text> </paragraph> <paragraph num="E."> <text>On the basis of the data collected and of any other information available, the Department shall periodically revise and update:</text> <paragraph num="(1)"> <text>The information provided to parents at the times of birth and of administration of pertussis vaccine;</text> </paragraph> <paragraph num="(2)"> <text>The information provided to health care providers regarding pertussis immunization deferral or exemption, and all other information otherwise regarding risks and benefits to the patient and to the public; and</text> </paragraph> <paragraph num="(3)"> <text>Other pertinent information on pertussis and pertussis vaccine</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Department shall report to the Centers for Disease Control (CDC) the incidence of pertussis and major adverse reactions to pertussis vaccine.</text> </paragraph> <paragraph num="G."> <text>The Department shall notify by mail or other means, or both, all health care providers of their responsibilities relevant to these regulations as well as other appropriate materials (for example, ACIP recommendations, parent information pamphlets, and morbidity report cards). Revisions of these and new materials shall also be distributed in the same manner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="General."> <text>Nothing in these regulations shall be construed to affect any emergency authority of the Secretary of Health and under any other provision of law to protect the public health.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b)(1) and 18-332, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 19, 1986 (13:10 Md. R. 1156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 10, 2009 (36:16 Md. R. 1251)</annotation> </annotations> </chapter> <chapter num="06" heading="Use of Tanning Devices by Minors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes regulations on the use of tanning devices by minors.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter preempts a county or municipal government from enacting and enforcing more stringent measures to regulate the use of tanning devices by minors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Customer” means a member of the public who is provided access to a tanning device in exchange for a fee, membership dues, or other compensation.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Health officer” means the health officer of each of the 23 counties in Maryland and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(4)"> <text>“Minor” means an individual younger than 18 years old.</text> </paragraph> <paragraph num="(5)"> <text>“Owner” means an individual or entity having an ownership interest in a tanning facility.</text> </paragraph> <paragraph num="(6)"> <text>“Person-in-charge” means an owner, operator, manager, employee, or other individual who controls, governs, or directs the activities of a tanning facility and is present on site.</text> </paragraph> <paragraph num="(7)"> <text>“Phototherapy device” means any equipment that emits ultraviolet radiation and is used in the diagnosis or treatment of disease or injury.</text> </paragraph> <paragraph num="(8)"> <text>“Radiation” means ultraviolet radiation.</text> </paragraph> <paragraph num="(9)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> <paragraph num="(10)"> <text>“Tanning device” means any equipment that emits radiation used for tanning of the skin, including sunlamps, tanning booths, or tanning beds.</text> </paragraph> <paragraph num="(11)"> <text>“Tanning facility” means any place where a tanning device is used for a fee, membership dues, or other compensation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Exclusions."> <text>This chapter does not apply to the use of any phototherapy device by a health care practitioner acting within the scope of the license of the health care practitioner or by order of a health care practitioner acting within the scope of the license of the health care practitioner.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Verification of Age."> <text>A person-in-charge may not allow a customer to use a tanning device at a tanning facility without confirmation, with a State or federal government-issued identification card, that the individual is not a minor.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Posting of Notices."> <paragraph num="A."> <text>A tanning facility shall display conspicuously a notice that conforms to the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>The notice shall state:</text> <paragraph num="(1)"> <text>That it is unlawful for a tanning facility owner, employee, or operator to allow a minor to use any tanning device;</text> </paragraph> <paragraph num="(2)"> <text>That a tanning facility owner, employee, or operator that violates one or more provisions of this section may be subject to a civil penalty;</text> </paragraph> <paragraph num="(3)"> <text>The health risks associated with tanning, including skin cancer, premature skin aging, injuries including burns, and adverse reactions when combined with certain medications, foods, and cosmetics; and</text> </paragraph> <paragraph num="(4)"> <text>That an individual may report a violation of one or more provisions of this chapter to the local law enforcement agency or local health department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice shall be:</text> <paragraph num="(1)"> <text>Readily visible and at least 18-point type font; and</text> </paragraph> <paragraph num="(2)"> <text>Made available to a tanning facility by the Department on the Department’s website.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The owner or person-in-charge shall ensure that the notice required under this regulation is conspicuously posted and in good condition.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Complaints and Investigations."> <paragraph num="A."> <text>A person or law enforcement officer may report a violation of this chapter to the health officer in the jurisdiction where the alleged violation took place.</text> </paragraph> <paragraph num="B."> <text>The Department shall make available a complaint form at the Department's website and at a local health department.</text> </paragraph> <paragraph num="C."> <text>Upon receipt of a complaint, the health officer shall investigate the complaint.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Enforcement."> <paragraph num="A."> <text>A health officer may investigate conditions relative to the enforcement of this chapter.</text> </paragraph> <paragraph num="B."> <text>The person-in-charge of a tanning facility shall permit a health officer to enter the tanning facility during business hours for the purpose of determining compliance with this chapter.</text> </paragraph> <paragraph num="C."> <text>If an investigation is made, the health officer shall:</text> <paragraph num="(1)"> <text>Document:</text> <paragraph num="(a)"> <text>The result of the investigation on a report form provided by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>A condition found that is in violation of a provision of this chapter;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Furnish one copy of the report form to the person-in-charge of the tanning facility; and</text> </paragraph> <paragraph num="(3)"> <text>Make the completed report form available for public disclosure in accordance with the Maryland Public Information Act, State Government Article, §§10-611—10-628, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Violations and Certification of Correction."> <paragraph num="A."> <text>The health officer shall provide the owner of a tanning facility found in violation of a provision of this chapter or Health-General Article, §20-106, Annotated Code of Maryland, with a written notice that contains:</text> <paragraph num="(1)"> <text>The specific finding and, if applicable, the penalty for the violation, as set forth in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>A specific date by which the owner shall correct the violation;</text> </paragraph> <paragraph num="(3)"> <text>A provision that, if the owner fails to correct the violation by the date specified or is in violation of another provision of Health-General Article, §20-106, Annotated Code of Maryland, at another time, the Secretary may impose a subsequent penalty, if applicable, as set forth in Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>A provision that the owner is entitled to request a hearing under Regulation .10 of this chapter on a violation with a penalty.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The owner of a tanning facility shall submit to the health officer a written certification of correction within a time frame provided by the local health department that states:</text> <paragraph num="(1)"> <text>The violation; and</text> </paragraph> <paragraph num="(2)"> <text>How the violation was corrected.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Penalties."> <text>The penalties for a violation of Regulation .04 or .05 of this chapter, or of Health-General Article, §20-106, Annotated Code of Maryland, are:</text> <paragraph num="A."> <text>A letter of reprimand for the first violation;</text> </paragraph> <paragraph num="B."> <text>A civil penalty of $250 for a second violation;</text> </paragraph> <paragraph num="C."> <text>A civil penalty of $500 for a third violation; and</text> </paragraph> <paragraph num="D."> <text>A civil penalty of $1,000 for each subsequent violation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Request for Hearing."> <paragraph num="A."> <text>A person who receives a notice of violation with a penalty for a violation of Regulation .04, .05C, D, or E, or .06 of this chapter, or of Health-General Article, §20-106, Annotated Code of Maryland, may request a hearing on the notice of violation with a penalty.</text> </paragraph> <paragraph num="B."> <text>In order to preserve a right to a hearing on a violation with a penalty under this chapter, if a hearing is desired, a person shall submit a written request to the Department’s Environmental Health Bureau under the Prevention and Health Promotion Administration for a hearing within 10 days of receipt of the notice of violation with a penalty.</text> </paragraph> <paragraph num="C."> <text>In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation with a penalty by referring the matter to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="D."> <text>The Office of Administrative Hearings shall:</text> <paragraph num="(1)"> <text>Schedule and conduct the hearing on the violation with a penalty; and</text> </paragraph> <paragraph num="(2)"> <text>Render a decision and notify the parties of the decision within 90 days after the hearing.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §20-106, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 29, 2009 (36:13 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 5, 2020 (47:20 Md. R. 875)</annotation> </annotations> </chapter> <chapter num="07" heading="State Advisory Council on Health and Wellness"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Chronic disease” means a noncommunicable condition that is a major cause of sickness or disability, including, but not limited to:</text> <paragraph num="(a)"> <text>Heart disease;</text> </paragraph> <paragraph num="(b)"> <text>Cancer;</text> </paragraph> <paragraph num="(c)"> <text>Arthritis; and</text> </paragraph> <paragraph num="(d)"> <text>Diabetes.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Council” means the State Advisory Council on Health and Wellness established by Health-General Article, §13-202, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Evidence-based program” means a program that:</text> <paragraph num="(a)"> <text>Engages the community in assessment and decision making;</text> </paragraph> <paragraph num="(b)"> <text>Uses data and information systems to inform program activities;</text> </paragraph> <paragraph num="(c)"> <text>Is based on peer-reviewed evidence;</text> </paragraph> <paragraph num="(d)"> <text>Uses program-planning frame works;</text> </paragraph> <paragraph num="(e)"> <text>Conducts evaluation; and</text> </paragraph> <paragraph num="(f)"> <text>Disseminates the results of the evaluation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Healthy lifestyle” means behaviors that promote wellness and prevent disease including, but not limited to:</text> <paragraph num="(a)"> <text>Maintaining a healthy weight;</text> </paragraph> <paragraph num="(b)"> <text>Engaging in regular physical activity;</text> </paragraph> <paragraph num="(c)"> <text>Refraining from smoking;</text> </paragraph> <paragraph num="(d)"> <text>Limiting consumption of alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Reducing stress; and</text> </paragraph> <paragraph num="(f)"> <text>Getting sufficient sleep.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Quorum” means a majority of the full membership of the Council or of a committee.</text> </paragraph> <paragraph num="(6)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Membership."> <paragraph num="A."> <text>The Council shall consist of 34 members appointed by the Secretary according to Health-General Article, §13-203, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A member shall:</text> <paragraph num="(1)"> <text>Be a Maryland resident; or</text> </paragraph> <paragraph num="(2)"> <text>If a qualified Maryland resident is not available to be appointed to a Council position, possess special knowledge or training required for the Council position to which they are appointed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A member that is subject to term limits:</text> <paragraph num="(1)"> <text>Shall serve a 4-year term;</text> </paragraph> <paragraph num="(2)"> <text>May serve two consecutive full terms;</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, shall continue to serve until a successor is appointed and qualifies;</text> </paragraph> <paragraph num="(4)"> <text>If appointed after a term has begun, shall only serve for the rest of the term and until a successor is appointed and qualifies; and</text> </paragraph> <paragraph num="(5)"> <text>May not be reappointed to the Council for 4 years after serving two consecutive full terms.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Members shall serve on at least one committee.</text> </paragraph> <paragraph num="E."> <text>The Council Chair shall:</text> <paragraph num="(1)"> <text>Be appointed by the Secretary;</text> </paragraph> <paragraph num="(2)"> <text>Serve a 2-year term;</text> </paragraph> <paragraph num="(3)"> <text>Be allowed to serve two consecutive terms; and</text> </paragraph> <paragraph num="(4)"> <text>Appoint the Chairs of the committees.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Committees."> <paragraph num="A."> <text>The Council shall have the following four committees:</text> <paragraph num="(1)"> <text>Arthritis;</text> </paragraph> <paragraph num="(2)"> <text>Diabetes;</text> </paragraph> <paragraph num="(3)"> <text>Heart Disease and Stroke; and</text> </paragraph> <paragraph num="(4)"> <text>Physical Fitness.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Council may create:</text> <paragraph num="(1)"> <text>Additional committees to organize the Council’s work; and</text> </paragraph> <paragraph num="(2)"> <text>Temporary ad hoc committees to accomplish a specific task.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except for the committees created according to §A of this regulation, the Council may dissolve a committee at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Council Duties."> <paragraph num="A."> <text>The Council shall:</text> <paragraph num="(1)"> <text>Provide guidance to the Secretary on Statewide chronic disease prevention and control;</text> </paragraph> <paragraph num="(2)"> <text>Direct the priorities and work of the committees; and</text> </paragraph> <paragraph num="(3)"> <text>Promote evidence-based programs for:</text> <paragraph num="(a)"> <text>Healthy lifestyles; and</text> </paragraph> <paragraph num="(b)"> <text>The prevention, early detection, and treatment of chronic disease.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Council shall submit a report of its activities to the Secretary on or before December 31, 2019 and every 2 years thereafter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Meetings and Procedures."> <paragraph num="A."> <text>Meeting Frequency.</text> <paragraph num="(1)"> <text>The Council shall meet at least two times per year.</text> </paragraph> <paragraph num="(2)"> <text>A committee created by Regulation .03A of this chapter shall meet at least four times per year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Quorum.</text> <paragraph num="(1)"> <text>A quorum shall be present to conduct a Council or committee vote.</text> </paragraph> <paragraph num="(2)"> <text>If a quorum is not present:</text> <paragraph num="(a)"> <text>A meeting may still be held; and</text> </paragraph> <paragraph num="(b)"> <text>An activity requiring a vote shall be deferred to the next meeting with a quorum present.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Voting.</text> <paragraph num="(1)"> <text>A member shall have one vote.</text> </paragraph> <paragraph num="(2)"> <text>Voting shall be:</text> <paragraph num="(a)"> <text>In person; or</text> </paragraph> <paragraph num="(b)"> <text>By phone.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Attendance.</text> <paragraph num="(1)"> <text>A member shall attend at least:</text> <paragraph num="(a)"> <text>50 percent of the Council meetings per year; and</text> </paragraph> <paragraph num="(b)"> <text>75 percent of the meetings of a committee on which the member serves per year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Council shall ensure that attendance is:</text> <paragraph num="(a)"> <text>Recorded in the meeting minutes; and</text> </paragraph> <paragraph num="(b)"> <text>Submitted to the Secretary at least once per year.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Secretary may remove a member for:</text> <paragraph num="(a)"> <text>Neglect of duty;</text> </paragraph> <paragraph num="(b)"> <text>Incompetence;</text> </paragraph> <paragraph num="(c)"> <text>Misconduct;</text> </paragraph> <paragraph num="(d)"> <text>Malfeasance;</text> </paragraph> <paragraph num="(e)"> <text>Misfeasance in office; or</text> </paragraph> <paragraph num="(f)"> <text>Failing to meet the requirements of §D(1) of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-201—13-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 29, 2018 (45:2 Md. R. 69)</annotation> </annotations> </chapter> <chapter num="08" heading="Maryland HIV Prevention Case Management Program"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <text>This chapter:</text> <paragraph num="A."> <text>Defines the Maryland AIDS Drug Assistance Program Fund;</text> </paragraph> <paragraph num="B."> <text>Sets forth the responsibilities of the Maryland Department of Health with respect to the Maryland AIDS Drug Assistance Program Fund; and</text> </paragraph> <paragraph num="C."> <text>Establishes eligibility criteria for receipt of HIV prevention and care services from the Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Fund” means the Maryland AIDS Assistance Program Fund.</text> </paragraph> <paragraph num="(4)"> <text>“Human immunodeficiency virus (HIV)” means the virus that causes AIDS.</text> </paragraph> <paragraph num="(5)"> <text>“Ryan White HIV/AIDS Program (RWHAP)” means the federal HIV/AIDS initiative administered by the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Maryland AIDS Drug Assistance Program Fund."> <paragraph num="A."> <text>The Maryland AIDS Drug Assistance Program Fund is a nonlapsing, special fund created by Health-General Article, §24-1801, Annotated Code of Maryland, for HIV treatment and care, which is generated from:</text> <paragraph num="(1)"> <text>The 340B Drug Pricing Program and any supplemental rebate dollars; and</text> </paragraph> <paragraph num="(2)"> <text>Interest earned on the balance of the Fund.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department may only expend funds in accordance with Title 26 of the Public Health Service Act governing the allowable uses of RWHAP funds or to meet State-identified HIV priorities.</text> </paragraph> <paragraph num="C."> <text>The Department may make grant awards under the Fund.</text> </paragraph> <paragraph num="D."> <text>Any unspent portions of the Fund shall remain in the Fund and may not revert to the General Fund of the State.</text> </paragraph> <paragraph num="E."> <text>Money expended from the Fund is additive to, and is not intended to take the place of, funding that would otherwise be appropriated to the Department for HIV:</text> <paragraph num="(1)"> <text>Surveillance;</text> </paragraph> <paragraph num="(2)"> <text>Prevention;</text> </paragraph> <paragraph num="(3)"> <text>Treatment; or</text> </paragraph> <paragraph num="(4)"> <text>Care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibilities of the Department."> <text>The Department:</text> <paragraph num="A."> <text>Shall administer the Fund; and</text> </paragraph> <paragraph num="B."> <text>May spend the Fund on statutorily permitted purposes under the RWHAP or State-identified HIV priorities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility Criteria."> <paragraph num="A."> <text>The Fund shall be the reasonable payor of last resort for receipt of HIV prevention and care services; and</text> </paragraph> <paragraph num="B."> <text>Eligible individuals shall have exhausted all other potential payors, including but not limited to:</text> <paragraph num="(1)"> <text>Third-party insurance;</text> </paragraph> <paragraph num="(2)"> <text>Medicaid; and</text> </paragraph> <paragraph num="(3)"> <text>Medicare.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">: Health-General Article, §24-1801, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.16 under Maryland HIV Prevention Case Management Program repealed and new Regulations .01—.05 under Maryland AIDS Drug Assistance Program Fund adopted effective December 25, 2023 (50:25 Md. R. 1088)</annotation> </annotations> </chapter> <chapter num="09" heading="HIV/CD4+ Lymphocyte Count Reporting by Unique Patient Identifying Number" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: June 1, 1994 (21:8 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective April 21, 1997 (24:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective April 21, 1997 (24:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 21, 1997 (24:8 Md. R. 616)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective June 16, 1998 (25:14 Md. R. 1128); amended permanently effective September 21, 1998 (25:19 Md. R. 1496)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective February 18, 2002 (29:3 Md. R. 220)</annotation> </annotations> </chapter> <chapter num="10" heading="HIV and Hepatitis C Testing of Persons Accused or Convicted, or Both, of Certain Crimes"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes procedures for HIV and hepatitis C testing ordered under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“County” means Baltimore City or a Maryland county.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>Exposure.</text> <paragraph num="(a)"> <text>“Exposure” means one of the following:</text> <paragraph num="(i)"> <text>Percutaneous contact of a victim with blood or body fluids of an offender;</text> </paragraph> <paragraph num="(ii)"> <text>Mucocutaneous contact of a victim with blood or body fluids of an offender;</text> </paragraph> <paragraph num="(iii)"> <text>Open wound, including dermatitis, exudative lesions, or chapped skin, contact of a victim with blood or body fluids of an offender for a prolonged period; or</text> </paragraph> <paragraph num="(iv)"> <text>Intact skin contact of a victim with large amounts of blood or body fluids of an offender for a prolonged period.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Exposure” includes a prohibited exposure as defined by Criminal Procedure Article, §11-107(e), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Health officer” means the Baltimore City Commissioner of Health or the health officer of a county.</text> </paragraph> <paragraph num="(5)"> <text>“HIV” means a human immunodeficiency virus that causes acquired immune deficiency syndrome.</text> </paragraph> <paragraph num="(6)"> <text>“Intact skin contact of a victim with large amounts of blood or body fluids of an offender for a prolonged period” means that a large volume of blood or bloody body fluid of an offender has been in direct contact with unbroken skin of a victim for at least 60 minutes.</text> </paragraph> <paragraph num="(7)"> <text>“Local health department” means the official public health agency in Baltimore City or a Maryland county.</text> </paragraph> <paragraph num="(8)"> <text>“Mucocutaneous contact of a victim with blood or body fluids of an offender” means that blood or bloody body fluid of an offender has splashed into the eye, mouth, or nose of a victim.</text> </paragraph> <paragraph num="(9)"> <text>“Offender” means one of the following:</text> <paragraph num="(a)"> <text>An individual convicted of an offense and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>An individual being granted probation before judgment and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>An individual charged with an offense and ordered by a court to furnish a sample to be tested for the presence of HIV or hepatitis C under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Offense” means any criminal offense or delinquent act the commission of which may have caused or resulted in an exposure.</text> </paragraph> <paragraph num="(11)"> <text>“Open wound contact of a victim with blood or body fluids of an offender for a prolonged period” means that blood or bloody body fluid of an offender has contacted an already existing open wound, sore, or chapped or non-intact skin of a victim for at least 5 minutes.</text> </paragraph> <paragraph num="(12)"> <text>“Percutaneous contact of a victim with blood or body fluids of an offender” means that a sharp object has penetrated the skin of a victim and allowed the blood or bloody body fluid of an offender to enter the victim's body.</text> </paragraph> <paragraph num="(13)"> <text>Residence.</text> <paragraph num="(a)"> <text>“Residence” means the location where an individual normally resides.</text> </paragraph> <paragraph num="(b)"> <text>“Residence” includes a facility where an offender is incarcerated, operated by the Department of Public Safety and Correctional Services or a Maryland county.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(15)"> <text>Victim.</text> <paragraph num="(a)"> <text>“Victim” means an individual, other than the offender, injured during the commission of an offense.</text> </paragraph> <paragraph num="(b)"> <text>“Victim” includes the:</text> <paragraph num="(i)"> <text>Parent of a victim who is a minor;</text> </paragraph> <paragraph num="(ii)"> <text>Legal guardian of a victim;</text> </paragraph> <paragraph num="(iii)"> <text>Individual authorized to give surrogate consent for the victim under Health-General Article, §5-605, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iv)"> <text>Victim as defined by Criminal Procedure Article, §11-107(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Notice."> <paragraph num="A."> <text>The health officer shall require receipt of a written notice and a copy of a court order for testing from a State’s Attorney before initiating the process of HIV or hepatitis C testing and notification described in this chapter.</text> </paragraph> <paragraph num="B."> <text>The State's Attorney shall include all of the following in the written notice:</text> <paragraph num="(1)"> <text>The name of the offender to be tested;</text> </paragraph> <paragraph num="(2)"> <text>The address of the offender's residence;</text> </paragraph> <paragraph num="(3)"> <text>The name of the victim who has requested information; and</text> </paragraph> <paragraph num="(4)"> <text>The address of the victim's residence.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the current residence of the offender is outside of the county or counties served by the health officer who receives the notification described in §A of this regulation, the health officer shall:</text> <paragraph num="(1)"> <text>Send a copy of the written notice and a copy of the court order for testing to the health officer of the county in which the offender resides; and</text> </paragraph> <paragraph num="(2)"> <text>Request the assistance of the health officer of the county in which the offender resides in carrying out the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the current residence of the victim is in Maryland but outside of the county or counties served by the health officer who receives the notification described in §A of this regulation, the health officer shall:</text> <paragraph num="(1)"> <text>Send a copy of the written notice and a copy of the court order for testing to the health officer of the county where the victim resides; and</text> </paragraph> <paragraph num="(2)"> <text>Request assistance with carrying out the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the current residence of the victim is outside of Maryland, the health officer who receives the notification described in §A of this regulation shall send a letter to:</text> <paragraph num="(1)"> <text>The state health department of the state in which the victim resides, requesting assistance with providing appropriate services to the victim; and</text> </paragraph> <paragraph num="(2)"> <text>The victim, explaining that the victim may do one of the following to obtain information about the offender’s HIV or hepatitis C test result:</text> <paragraph num="(a)"> <text>Contact the state health department in the state where the victim resides; or</text> </paragraph> <paragraph num="(b)"> <text>Contact the local health department notified under §A of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibility."> <paragraph num="A."> <text>The health officer of the county in which the offender currently resides shall assume responsibility for carrying out the activities described in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The health officer of the county in which the victim currently resides shall assume responsibility for carrying out the activities described in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>If the current residence of the victim is outside of Maryland, the health officer notified under Regulation .03A of this chapter shall assume responsibility for carrying out the activities described in Regulation .06 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Testing of Offender."> <paragraph num="A."> <text>HIV and Hepatitis C Testing.</text> <paragraph num="(1)"> <text>Specimen Collection.</text> <paragraph num="(a)"> <text>A specimen shall be collected from an offender following the methods described in the specifications for the blood or oral fluid test used.</text> </paragraph> <paragraph num="(b)"> <text>The local health department shall provide guidance on how specimens shall be collected.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the offender is incarcerated in a facility under the jurisdiction of the Department of Public Safety and Correctional Services, HIV and hepatitis C testing of the offender may be performed by an employee or contractor of either the:</text> <paragraph num="(a)"> <text>Local health department; or</text> </paragraph> <paragraph num="(b)"> <text>Department of Public Safety and Correctional Services.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the offender is incarcerated in a facility under the jurisdiction of the county, HIV and hepatitis C testing may be performed by an employee or contractor of either the:</text> <paragraph num="(a)"> <text>Local health department; or</text> </paragraph> <paragraph num="(b)"> <text>County.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the offender is not incarcerated, an employee or contractor of the local health department shall perform HIV and hepatitis C testing of the offender.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The health officer shall send a certified letter, accompanied by a copy of the court order for testing, to each offender who is not incarcerated, to notify the offender of all of the following:</text> <paragraph num="(1)"> <text>That the health officer has been instructed by the court to perform an HIV or hepatitis C test on the offender; and</text> </paragraph> <paragraph num="(2)"> <text>That the offender has been scheduled for a test at a specified date, time, and place.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The health officer or designee shall do all of the following:</text> <paragraph num="(1)"> <text>Conduct a face-to-face discussion with the offender before a sample is collected for an HIV or hepatitis C test;</text> </paragraph> <paragraph num="(2)"> <text>Include all of the topics described in COMAR 10.18.08.06 regarding the offender’s HIV test in the discussion; and</text> </paragraph> <paragraph num="(3)"> <text>Sign a form indicating that the health officer or designee offered information to the offender on the HIV or hepatitis C test.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Blood Drawing and Testing.</text> <paragraph num="(1)"> <text>The health officer may not use the result of a previous HIV or hepatitis C test instead of conducting an HIV or hepatitis C test required under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The health officer may not use a sample taken for another purpose instead of obtaining a sample in order to conduct an HIV or hepatitis C test required under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>The health officer or designee shall:</text> <paragraph num="(a)"> <text>Obtain a sample from the offender;</text> </paragraph> <paragraph num="(b)"> <text>Put the code “RP” on the blood sample and the test order; and</text> </paragraph> <paragraph num="(c)"> <text>Send the sample to the Laboratories Administration within the Department for an HIV or hepatitis C test.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Upon receipt of the test result of the offender, the health officer or designee shall:</text> <paragraph num="(1)"> <text>Discuss the result with the offender; or</text> </paragraph> <paragraph num="(2)"> <text>Transmit the test result to the individual designated by the health officer to provide post-test information, including the topics listed in COMAR 10.18.08 that are applicable to the HIV test result.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Charges. The local health department shall charge the offender for the expenses incurred in carrying out the responsibilities outlined in this regulation if the court has ordered the defendant to make restitution for expenses incurred by the Department under Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </paragraph> <paragraph num="G."> <text>State’s Attorney Notification. The health officer shall notify the State’s Attorney who transmitted the victim’s request for an HIV or hepatitis C test when one or more of the following actions occurs:</text> <paragraph num="(1)"> <text>HIV or hepatitis C testing of an offender, including pretest and post-test information, is completed;</text> </paragraph> <paragraph num="(2)"> <text>An offender refuses to allow a sample to be taken for testing;</text> </paragraph> <paragraph num="(3)"> <text>An offender ordered by the court to make restitution for expenses incurred by the Department refuses to pay the required amount; or</text> </paragraph> <paragraph num="(4)"> <text>An offender who is not incarcerated fails to appear for HIV or hepatitis C testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Information for the Victim."> <paragraph num="A."> <text>The health officer or designee shall provide the victim with information addressing all of the following:</text> <paragraph num="(1)"> <text>An explanation of HIV, AIDS, and hepatitis C;</text> </paragraph> <paragraph num="(2)"> <text>An explanation of the risks of HIV and hepatitis C transmission in the course of a sexual or other offense;</text> </paragraph> <paragraph num="(3)"> <text>The advisability of HIV and hepatitis C testing of the victim;</text> </paragraph> <paragraph num="(4)"> <text>The advisability of the victim taking precautions to prevent the spread of HIV and hepatitis C until it is certain that the victim is not infected;</text> </paragraph> <paragraph num="(5)"> <text>The advisability of the victim starting post-exposure prophylaxis prior to receiving test results; and</text> </paragraph> <paragraph num="(6)"> <text>The HIV and hepatitis C test result of the offender.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the HIV or hepatitis C test result of the offender is positive, the health officer or designee shall offer, provide, or arrange for appropriate HIV or hepatitis C services, including referral for appropriate health care and support services, for the victim.</text> </paragraph> <paragraph num="C."> <text>If the HIV test result of the offender is indeterminate, the health officer or designee of the health officer shall inform the victim about the advisability of requesting the court to order a second HIV test 8 to 12 weeks after the first test to determine whether the test result has changed.</text> </paragraph> <paragraph num="D."> <text>The health officer or designee shall inform the victim about the requirements for confidentiality of information relating to the HIV or hepatitis C test result of the offender, as specified in Regulation .07C and D of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Confidentiality."> <paragraph num="A."> <text>Local Health Department Records. The local health department shall maintain separate confidential records of information and test results given to an offender required under the provisions of Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Disclosure by Health Officer or Designee.</text> <paragraph num="(1)"> <text>Except as provided in Regulations .05E and .06A(6) of this chapter and as otherwise provided by law, the health officer or designee may not disclose the HIV or hepatitis C result of the offender.</text> </paragraph> <paragraph num="(2)"> <text>The health officer or designee may not place the HIV or hepatitis C test result of the offender in any record relating to the offender maintained within a facility in which the offender is incarcerated.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Disclosure by Victim. The victim may not disclose the offender's test result to any individual unless the disclosure is necessary to protect the health and safety of:</text> <paragraph num="(1)"> <text>The victim;</text> </paragraph> <paragraph num="(2)"> <text>The victim's sexual partner; or</text> </paragraph> <paragraph num="(3)"> <text>The victim's family.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Redisclosure. An individual notified of the result of an HIV or hepatitis C test performed under provisions of this chapter may not disclose the information except to protect the health and safety of:</text> <paragraph num="(1)"> <text>The victim;</text> </paragraph> <paragraph num="(2)"> <text>The victim's sexual partner; or</text> </paragraph> <paragraph num="(3)"> <text>The victim's family.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Criminal Procedure Article §§11-107—11-117, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 20, 1993 (20:25 Md. R. 1948)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, E amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 7, 2018 (45:9 Md. R. 462)</annotation> </annotations> </chapter> <chapter num="11" heading="Universal Infection Control Precautions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations apply to any of the following individuals when the individual is involved in patient care activities:</text> <paragraph num="(1)"> <text>Acupuncturist;</text> </paragraph> <paragraph num="(2)"> <text>Dental hygienist;</text> </paragraph> <paragraph num="(3)"> <text>Dentist;</text> </paragraph> <paragraph num="(4)"> <text>Electrologist;</text> </paragraph> <paragraph num="(5)"> <text>Employee of a health care facility;</text> </paragraph> <paragraph num="(6)"> <text>Employee of a health care professional;</text> </paragraph> <paragraph num="(7)"> <text>Mortician;</text> </paragraph> <paragraph num="(8)"> <text>Nurse;</text> </paragraph> <paragraph num="(9)"> <text>Physician;</text> </paragraph> <paragraph num="(10)"> <text>Physician assistant; and</text> </paragraph> <paragraph num="(11)"> <text>Podiatrist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>These regulations apply to any health care facility or private professional office where a health care worker is involved in patient care activities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assisted living facility” has the meaning for assisted living program stated in Health-General Article, §19-1801, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Day care center for adults” has the meaning stated in Health-General Article, §14-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Freestanding birthing center” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Freestanding medical facility” has the meaning stated in Health-General Article, §19-3A-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>Health Care Facility.</text> <paragraph num="(a)"> <text>“Health care facility” means a location where health care is provided, including:</text> <paragraph num="(i)"> <text>Assisted living facility;</text> </paragraph> <paragraph num="(ii)"> <text>Day care center for adults;</text> </paragraph> <paragraph num="(iii)"> <text>Freestanding birthing center;</text> </paragraph> <paragraph num="(iv)"> <text>Freestanding medical facility;</text> </paragraph> <paragraph num="(v)"> <text>Health maintenance organization;</text> </paragraph> <paragraph num="(vi)"> <text>Hospital;</text> </paragraph> <paragraph num="(vii)"> <text>Managed care organization;</text> </paragraph> <paragraph num="(viii)"> <text>Nursing home; and</text> </paragraph> <paragraph num="(ix)"> <text>Related institution.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care facility” does not include a private professional office.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Health care professional” means an individual who is licensed or certified under one or more of the following titles of Health Occupations Article, Annotated Code of Maryland:</text> <paragraph num="(a)"> <text>Title 4 Dentistry;</text> </paragraph> <paragraph num="(b)"> <text>Title 6 Electrologists;</text> </paragraph> <paragraph num="(c)"> <text>Title 7 Morticians;</text> </paragraph> <paragraph num="(d)"> <text>Title 8 Nurses;</text> </paragraph> <paragraph num="(e)"> <text>Title 14 Physicians;</text> </paragraph> <paragraph num="(f)"> <text>Title 15 Physician Assistants; and</text> </paragraph> <paragraph num="(g)"> <text>Title 16 Podiatrists.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Health care worker” means an individual who is:</text> <paragraph num="(a)"> <text>A health care professional;</text> </paragraph> <paragraph num="(b)"> <text>An employee of a health care professional; or</text> </paragraph> <paragraph num="(c)"> <text>An employee of a health care facility.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Managed care organization” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Nursing home” means either:</text> <paragraph num="(a)"> <text>A comprehensive care facility, as defined in COMAR 10.07.02.01B(6); or</text> </paragraph> <paragraph num="(b)"> <text>An extended care facility, as defined in COMAR 10.07.02.01B(12).</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Patient care activity” means an action performed by a health care worker for a patient which could result in one or more of the following:</text> <paragraph num="(a)"> <text>Blood or body fluids of the patient touching non-intact skin or mucous membrane of the health care worker;</text> </paragraph> <paragraph num="(b)"> <text>Blood or body fluids of the health care worker touching nonintact skin or mucous membrane of the patient;</text> </paragraph> <paragraph num="(c)"> <text>Percutaneous contact of the health care worker with the blood or body fluids of the patient; or</text> </paragraph> <paragraph num="(d)"> <text>Percutaneous contact of the patient with the blood or body fluids of the health care worker.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Private professional office” means a location which is not a part of a health care facility where a health care professional provides services to the public on a regular basis.</text> </paragraph> <paragraph num="(14)"> <text>“Related institution” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Compliance Requirements for an Individual."> <text>An individual who is performing patient care activities shall:</text> <paragraph num="A."> <text>Comply with the principles of universal precautions;</text> </paragraph> <paragraph num="B."> <text>If necessary, make an emergency exception to the use of universal precautions in a situation when failure to provide immediate care could result in serious harm to or death of a patient; and</text> </paragraph> <paragraph num="C."> <text>Comply with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures, including:</text> <paragraph num="(1)"> <text>Prohibiting the reuse of single use needles; and</text> </paragraph> <paragraph num="(2)"> <text>Properly disposing of needles and other sharps devices.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Compliance Requirements for a Health Care Facility."> <paragraph num="A."> <text>A health care facility shall:</text> <paragraph num="(1)"> <text>Adopt, implement, and enforce a policy that:</text> <paragraph num="(a)"> <text>Requires the use of universal precautions by medical staff and employees engaged in patient care activities,</text> </paragraph> <paragraph num="(b)"> <text>Permits an individual to make an emergency exception to the use of universal precautions, at the individual's discretion, in a situation where failure to provide immediate care could result in serious harm to or death of a patient, and</text> </paragraph> <paragraph num="(c)"> <text>Requires compliance with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Display the version of the notice “We Take Precautions for You” specified in Table A, shown in §B of this regulation, at the entrance to the health care facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Table A.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Compliance Requirements for Health Care Professional with Private Professional Office."> <paragraph num="A."> <text>A health care professional who practices in a private professional office shall:</text> <paragraph num="(1)"> <text>Ensure that an individual who performs patient care services in the professional's office:</text> <paragraph num="(a)"> <text>Complies with the principles of universal precautions,</text> </paragraph> <paragraph num="(b)"> <text>Is permitted to make an emergency exception to the use of universal precautions, at the individual's discretion, in a situation where failure to provide immediate care could result in serious harm to or death of a patient, and</text> </paragraph> <paragraph num="(c)"> <text>Complies with current professional standards of patient care with regard to disinfection and sterilization of reusable devices used in patient care procedures; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C of this regulation, display the version of the notice “We Take Precautions for You” specified in Table B shown in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Table B.</text> </paragraph> <paragraph num="C."> <text>A health care professional not listed in Table B is not required to post the notice “We Take Precautions for You”.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-102, 19-319(h), 19-3A-02(9) and (10), 19-705.3; Health Occupations Article, §§1-207, 4-313(d),4-315, 6-205, 6-312, 6-505, 7-205, 7-316, 8-205, 8-316, 8-506, 14-205, 14-404, 14-415, 14-506, 15-205, 15-314, 16-205, 16-312, and 16-404; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 14, 1994 (21:3 Md. R. 194)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 27, 2003 (30:21 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective October 27, 2003 (30:21 Md. R. 1529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective October 27, 2003 (30:21 Md. R. 1529)</annotation> </annotations> </chapter> <chapter num="12" heading="Newborn Screening"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter and COMAR 10.10.13 establish a coordinated Statewide system for:</text> <paragraph num="A."> <text>Laboratory screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development; and</text> </paragraph> <paragraph num="B."> <text>Follow-up services to those infants with abnormal screening results.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter identifies standards and requirements for the Department, birthing facilities, and persons participating in one or more aspects of Maryland's Newborn Screening Program for hereditary and congenital disorders.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Birthing Facility.</text> <paragraph num="(a)"> <text>“Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants.</text> </paragraph> <paragraph num="(b)"> <text>“Birthing facility” includes a:</text> <paragraph num="(i)"> <text>Birthing service that is licensed or accredited as a unit of a hospital; and</text> </paragraph> <paragraph num="(ii)"> <text>Freestanding birthing center as defined in COMAR 10.05.02.01B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Blood-Spot Specimen.</text> <paragraph num="(a)"> <text>“Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot specimen collection test requisition card for the purpose of performing screening tests.</text> </paragraph> <paragraph num="(b)"> <text>“Blood-spot specimen” includes:</text> <paragraph num="(i)"> <text>The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth;</text> </paragraph> <paragraph num="(ii)"> <text>The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and</text> </paragraph> <paragraph num="(iii)"> <text>A blood-spot specimen collected subsequent to a specimen specified in §B(2)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.10.13.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Congenital Disorder.</text> <paragraph num="(a)"> <text>“Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth.</text> </paragraph> <paragraph num="(b)"> <text>“Congenital disorder” does not include a condition that results from:</text> <paragraph num="(i)"> <text>An intrauterine infection; or</text> </paragraph> <paragraph num="(ii)"> <text>A birth injury.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Council” means the State Advisory Council on Hereditary and Congenital Disorders.</text> </paragraph> <paragraph num="(5)"> <text>“Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Diagnostic test” means a test that is used to establish or confirm the presence of a:</text> <paragraph num="(a)"> <text>Specific disease; or</text> </paragraph> <paragraph num="(b)"> <text>Hereditary or congenital disorder.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth.</text> </paragraph> <paragraph num="(9)"> <text>“First-tier test” means a blood test performed on a newborn infant's blood that:</text> <paragraph num="(a)"> <text>Indicates the probable presence or absence of a hereditary or congenital disorder; or</text> </paragraph> <paragraph num="(b)"> <text>Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>Hereditary Disorder.</text> <paragraph num="(a)"> <text>“Hereditary disorder” means a disorder that:</text> <paragraph num="(i)"> <text>Is transmissible through the genetic material deoxyribonucleic acid (DNA); or</text> </paragraph> <paragraph num="(ii)"> <text>Arises through the improper processing of information in the genetic material.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Hereditary disorder” includes:</text> <paragraph num="(i)"> <text>Hemoglobin disorders;</text> </paragraph> <paragraph num="(ii)"> <text>Metabolic disorders; and</text> </paragraph> <paragraph num="(iii)"> <text>Endocrine disorders.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility.</text> </paragraph> <paragraph num="(13)"> <text>“Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified to practice under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(12) of this regulation.</text> </paragraph> <paragraph num="(14)"> <text>“Metabolic disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by:</text> <paragraph num="(a)"> <text>Direct analysis of the enzyme, hormone, or protein; or</text> </paragraph> <paragraph num="(b)"> <text>Testing for a substance whose metabolism is altered as a result of the defect.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Milk feeding” means feedings received for 24 hours by:</text> <paragraph num="(a)"> <text>A healthy newborn infant on a diet of milk; and</text> </paragraph> <paragraph num="(b)"> <text>An ill or premature newborn infant on parenteral feedings providing a minimum of 1 gram of protein per kilogram of body weight per day and 75 kilocalories per kilogram of body weight per day.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Newborn” or “newborn infant” means an infant:</text> <paragraph num="(a)"> <text>Born in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Born on federal property within Maryland;</text> </paragraph> <paragraph num="(c)"> <text>Born outside of Maryland to parents whose residence is in Maryland;</text> </paragraph> <paragraph num="(d)"> <text>From whom a blood-spot specimen was collected and submitted to the State’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth;</text> </paragraph> <paragraph num="(e)"> <text>Who has a screening test requested by the Follow-Up Unit:</text> <paragraph num="(i)"> <text>For first-tier screening follow-up;</text> </paragraph> <paragraph num="(ii)"> <text>For confirmation of a previous screening test result; or</text> </paragraph> <paragraph num="(iii)"> <text>To assist with the infant's diagnosis, therapy, or follow-up care; or</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Who is in Maryland.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Newborn Screening or Screening.</text> <paragraph num="(a)"> <text>“Newborn screening” or “screening” means one or more first-tier tests.</text> </paragraph> <paragraph num="(b)"> <text>“Newborn screening” or “screening” includes:</text> <paragraph num="(i)"> <text>First-tier testing on a first, second, or subsequent blood-spot specimen; and</text> </paragraph> <paragraph num="(ii)"> <text>Supplemental first-tier testing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(18)"> <text>Newborn Screening Program.</text> <paragraph num="(a)"> <text>“Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that:</text> <paragraph num="(i)"> <text>Newborn infants are given the opportunity to be tested;</text> </paragraph> <paragraph num="(ii)"> <text>At risk newborn infants who are tested are identified and located;</text> </paragraph> <paragraph num="(iii)"> <text>Newborn infants are given access to necessary follow-up testing;</text> </paragraph> <paragraph num="(iv)"> <text>Diagnostic tests are available and the diagnosis is made or ruled out; and</text> </paragraph> <paragraph num="(v)"> <text>Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Newborn Screening Program” includes:</text> <paragraph num="(i)"> <text>The Department's public health laboratory as the sole screening laboratory;</text> </paragraph> <paragraph num="(ii)"> <text>Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a formal Departmental mutual aid agreement;</text> </paragraph> <paragraph num="(iii)"> <text>Supplemental and second-tier testing performed by a state public health laboratory or by a licensed commercial or research laboratory;</text> </paragraph> <paragraph num="(iv)"> <text>The Follow-Up Unit; and</text> </paragraph> <paragraph num="(v)"> <text>The State Advisory Council on Hereditary and Congenital Disorders.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal.</text> </paragraph> <paragraph num="(20)"> <text>Second-Tier Test.</text> <paragraph num="(a)"> <text>“Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result.</text> </paragraph> <paragraph num="(b)"> <text>“Second-tier test” includes a test that:</text> <paragraph num="(i)"> <text>Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder;</text> </paragraph> <paragraph num="(ii)"> <text>Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or</text> </paragraph> <paragraph num="(iii)"> <text>Is diagnostic because it confirms the presence of a hereditary or congenital disorder.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is:</text> <paragraph num="(a)"> <text>Used to detect a hereditary or congenital disorder not specified in Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.10.13.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in COMAR 10.10.13.21B and C.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibilities of the Department."> <paragraph num="A."> <text>Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.</text> </paragraph> <paragraph num="B."> <text>Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory oversight that includes surveys and proficiency testing as set forth in:</text> <paragraph num="(1)"> <text>COMAR 10.10.02; and</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.10.05.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notification. The Department shall notify the parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory may perform post screening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Selection of Disorders for Screening."> <paragraph num="A."> <text>The Department, with the advice of the Council, shall select the disorders for which screening is required by the Newborn Screening Program.</text> </paragraph> <paragraph num="B."> <text>The selected disorders are:</text> <paragraph num="(1)"> <text>Biotinidase deficiency;</text> </paragraph> <paragraph num="(2)"> <text>Congenital adrenal hyperplasia (CAH);</text> </paragraph> <paragraph num="(3)"> <text>Hypothyroidism;</text> </paragraph> <paragraph num="(4)"> <text>Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT);</text> </paragraph> <paragraph num="(5)"> <text>Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE);</text> </paragraph> <paragraph num="(6)"> <text>Galactokinase Galactosemia, galactokinase deficiency (GALK1);</text> </paragraph> <paragraph num="(7)"> <text>Sickle cell disease;</text> </paragraph> <paragraph num="(8)"> <text>Sickle cell disease: S beta-thalessemia;</text> </paragraph> <paragraph num="(9)"> <text>Sickle C disease: SC disease;</text> </paragraph> <paragraph num="(10)"> <text>Other hemoglobin variants;</text> </paragraph> <paragraph num="(11)"> <text>Phenylketonuria (PKU);</text> </paragraph> <paragraph num="(12)"> <text>Hyperphenylalaninemia (Hyper-PHE);</text> </paragraph> <paragraph num="(13)"> <text>Biopterin cofactor biosynthesis defects (BIOPT-BS);</text> </paragraph> <paragraph num="(14)"> <text>Biopterin cofactor regeneration defects (BIOPT-REG);</text> </paragraph> <paragraph num="(15)"> <text>Tyrosinemia, type I;</text> </paragraph> <paragraph num="(16)"> <text>Tyrosinemia, type II;</text> </paragraph> <paragraph num="(17)"> <text>Tyrosinemia, type III;</text> </paragraph> <paragraph num="(18)"> <text>Homocystinuria;</text> </paragraph> <paragraph num="(19)"> <text>Hypermethioninemia;</text> </paragraph> <paragraph num="(20)"> <text>Branched chain ketoaciduria (BCK), also called maple syrup urine disease (MSUD);</text> </paragraph> <paragraph num="(21)"> <text>Citrullinemia, type I;</text> </paragraph> <paragraph num="(22)"> <text>Citrullinemia, type II;</text> </paragraph> <paragraph num="(23)"> <text>Arginosuccinic aciduria;</text> </paragraph> <paragraph num="(24)"> <text>Argininemia;</text> </paragraph> <paragraph num="(25)"> <text>Methylmalonic acidemia, mutase deficiency (MMA);</text> </paragraph> <paragraph num="(26)"> <text>Methylmalonic acidemia, adenosylcobalamin synthesis defects A and B (Cbl A, B);</text> </paragraph> <paragraph num="(27)"> <text>Methylmalonic acidemia, adenosylcobalamin synthesis defects C and D (Cbl C, D);</text> </paragraph> <paragraph num="(28)"> <text>Propionic acidemia (PA);</text> </paragraph> <paragraph num="(29)"> <text>Isovaleric acidemia (IVA);</text> </paragraph> <paragraph num="(30)"> <text>Glutaric aciduria type I (GA I);</text> </paragraph> <paragraph num="(31)"> <text>3-Hydroxy-3-methylglutaryl-CoA (HMG) lysase deficiency;</text> </paragraph> <paragraph num="(32)"> <text>Isobutryl-CoA dehydrogenase (IBCD) deficiency;</text> </paragraph> <paragraph num="(33)"> <text>2-Methylbutyryl-CoA dehydrogenase deficiency (2MBG);</text> </paragraph> <paragraph num="(34)"> <text>3-Methlycrotonyl-CoA carboxylase deficiency (3MCC);</text> </paragraph> <paragraph num="(35)"> <text>3-Methlyglutaconyl-CoA hydratase deficiency (3MGA);</text> </paragraph> <paragraph num="(36)"> <text>2-Methyl-3-hydroxybutyrl-CoA dehydrogenase deficiency (2M3HBA);</text> </paragraph> <paragraph num="(37)"> <text>Mitochondrial acetoacetyl-CoA thiolase (3-ketothiolase) deficiency (BKT);</text> </paragraph> <paragraph num="(38)"> <text>Multiple carboxylase deficiency (MCD);</text> </paragraph> <paragraph num="(39)"> <text>Malonic acidemia (MAL);</text> </paragraph> <paragraph num="(40)"> <text>Medium chain acyl-CoA dehydrogenase deficiency (MCAD);</text> </paragraph> <paragraph num="(41)"> <text>Medium chain ketoacyl-CoA thiolase deficiency (MCKAT);</text> </paragraph> <paragraph num="(42)"> <text>Short chain acyl-CoA dehydrogenase deficiency (SCAD);</text> </paragraph> <paragraph num="(43)"> <text>Short chain 3-hydroxy acyl Co-A dehydrogenase deficiency (SCHAD);</text> </paragraph> <paragraph num="(44)"> <text>Very long chain acyl-CoA dehydrogenase deficiency (VLCAD)</text> </paragraph> <paragraph num="(45)"> <text>3-hydroxy long chain acyl-CoA dehydrogenase deficiency (LCHAD);</text> </paragraph> <paragraph num="(46)"> <text>Multiple acyl-CoA dehydrogenase (MAD) or glutaric acidemia type II deficiency (GA II);</text> </paragraph> <paragraph num="(47)"> <text>Carnitine/acylcarnitine translocase deficiency (translocase deficiency);</text> </paragraph> <paragraph num="(48)"> <text>Carnitine palmitoyl transferase type I deficiency (CPT I);</text> </paragraph> <paragraph num="(49)"> <text>Carnitine palmitoyl transferase type II deficiency (CPT II);</text> </paragraph> <paragraph num="(50)"> <text>Carnitine uptake disorder;</text> </paragraph> <paragraph num="(51)"> <text>Trifunctional protein deficiency (TFP);</text> </paragraph> <paragraph num="(52)"> <text>2,4-dienoyl-CoA reductase deficiency (DE RED);</text> </paragraph> <paragraph num="(53)"> <text>Cystic fibrosis;</text> </paragraph> <paragraph num="(54)"> <text>Severe combined immunodeficiency (SCID);</text> </paragraph> <paragraph num="(55)"> <text>Pompe disease;</text> </paragraph> <paragraph num="(56)"> <text>Fabry disease;</text> </paragraph> <paragraph num="(57)"> <text>Spinal muscular atrophy (SMA);</text> </paragraph> <paragraph num="(58)"> <text>Mucopolysaccharidosis type I (MPS I);</text> </paragraph> <paragraph num="(59)"> <text>Mucopolysaccharidosis Type II (MPS II);</text> </paragraph> <paragraph num="(60)"> <text>X-linked Adrenoleukodystrophy (X-ALD);</text> </paragraph> <paragraph num="(61)"> <text>Guanidinoacetate Methyltransferase Deficiency (GAMT); and</text> </paragraph> <paragraph num="(62)"> <text>Infantile Krabbe Disease.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Supplemental Tests. The State’s Newborn Screening Program may not request or perform a supplemental test until the public health laboratory has confirmed there is sufficient blood-spot specimen to test for the required panel of disorders set forth in §B of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Pre-Test Information."> <text>Before a blood-spot specimen is sent for newborn screening, a health care provider or the individual’s designated representative shall provide to the newborn infant’s parent or guardian an explanation of newborn screening that includes:</text> <paragraph num="A."> <text>Reasons for newborn screening, including the;</text> <paragraph num="(1)"> <text>Purpose of the testing; and</text> </paragraph> <paragraph num="(2)"> <text>Nature and consequences of being affected by a hereditary or congenital disorder or being a carrier of a hereditary or congenital disorder; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>A parent or guardian's right to object to having the testing performed, including:</text> <paragraph num="(1)"> <text>Stating that newborn screening is wholly voluntary;</text> </paragraph> <paragraph num="(2)"> <text>Explaining any risk involved in having newborn screening performed; and</text> </paragraph> <paragraph num="(3)"> <text>Providing a reasonable opportunity to object to screening.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Initial Screening."> <text>The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:</text> <paragraph num="A."> <text>If the parent or guardian of the newborn infant does not object to newborn screening:</text> <paragraph num="(1)"> <text>Collect a blood-spot specimen:</text> <paragraph num="(a)"> <text>As set forth in:</text> <paragraph num="(i)"> <text>Sections C and D of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.10.13.13; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Pursuant to the procedures established in COMAR 10.10.13.14A; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Submit the collected blood-spot specimen to the Department’s public health laboratory;</text> </paragraph> </paragraph> <paragraph num="B."> <text>When a parent or guardian objects to newborn screening:</text> <paragraph num="(1)"> <text>Have the parent or guardian sign a form that states the parent or guardian objects to newborn screening; and</text> </paragraph> <paragraph num="(2)"> <text>Inform the Follow-Up Unit by telephone, fax, or email of the objection within 12 hours after the objection;</text> </paragraph> </paragraph> <paragraph num="C."> <text>For full-term healthy newborn infants:</text> <paragraph num="(1)"> <text>Collect a blood-spot specimen to test for the disorders set forth in Regulation .05 of this chapter not sooner than 24 hours after the onset of milk feeding, regardless of whether the newborn is breast-fed or formula-fed; and</text> </paragraph> <paragraph num="(2)"> <text>If the newborn infant is discharged before 24 hours after the onset of milk feeding, collect the blood-spot specimen as late as practical before the newborn infant is discharged from the birthing facility; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>For a newborn infant born prematurely or expected to be ill for longer than 14 days, if the newborn infant’s medical condition permits, collect:</text> <paragraph num="(1)"> <text>A blood-spot specimen for the newborn screening test upon admission, before the administration of blood products or antibiotics;</text> </paragraph> <paragraph num="(2)"> <text>A subsequent blood-spot specimen 48 to 72 hours after birth, regardless of milk feeding status;</text> </paragraph> <paragraph num="(3)"> <text>A subsequent blood-spot specimen by 10 days of age when milk feeding is established or the infant has been receiving additional protein through intravenous fluids; and</text> </paragraph> <paragraph num="(4)"> <text>An additional subsequent blood-spot specimen at one month of age or at discharge, whichever comes first.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Second Screening."> <text>A health care provider shall have a blood-spot specimen collected for a second screening for the disorders set forth in Regulation .05 of this chapter when the newborn is between 10 and 14 days old.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Transport of Blood-Spot Specimens to a Licensed Laboratory."> <paragraph num="A."> <text>A birthing facility representative, physician, or other health care provider or, in the case when a birth occurs outside a birthing facility, the individual required to prepare and file the certificate of birth, shall send newborn screening blood-spot specimens only to the Department’s public health laboratory for the performance of newborn screening, as set forth in COMAR 10.10.13.14B.</text> </paragraph> <paragraph num="B."> <text>The individual responsible for collecting and submitting a blood-spot specimen for a newborn screening test shall ensure that blood-spot specimens are forwarded by courier to the Department’s public health laboratory within 24 hours after collection.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Results."> <paragraph num="A."> <text>Normal Screening Results.</text> <paragraph num="(1)"> <text>The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen within 3 business days after receipt of the blood-spot specimen.</text> </paragraph> <paragraph num="(2)"> <text>A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:</text> <paragraph num="(a)"> <text>Enter the results in the newborn infant's medical record; and</text> </paragraph> <paragraph num="(b)"> <text>Make the results available to the parent, guardian, or primary care providers upon request.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Abnormal Screening Results.</text> <paragraph num="(1)"> <text>The Department’s public health laboratory shall immediately report abnormal newborn screening test results to the Follow-Up Unit.</text> </paragraph> <paragraph num="(2)"> <text>The Department’s public health laboratory shall report to the Follow-Up Unit all known demographic and clinical data on the newborn infant in an electronic format compatible with the Department’s information system databases operated by the Department’s public health laboratory, as set forth at COMAR 10.10.13.25.</text> </paragraph> <paragraph num="(3)"> <text>The Follow-Up Unit shall enter results in the Department’s database and initiate follow-up procedures as specified in Regulation .12 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>The submitter of the blood-spot specimen shall:</text> <paragraph num="(a)"> <text>Enter the results in the newborn infant's medical record; and</text> </paragraph> <paragraph num="(b)"> <text>Make the abnormal results available immediately to the newborn's parent, guardian, or primary care providers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Referral Procedures."> <text>The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:</text> <paragraph num="A."> <text>Develop collection and transport procedures to ensure against collecting and submitting unsatisfactory blood-spot specimens for each of the categories of newborn infant listed in §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>Collect or otherwise have collected:</text> <paragraph num="(1)"> <text>An additional blood-spot specimen before the newborn is 7 days old for newborn infants discharged before 24 hours of milk feeding in addition to the blood-spot specimen collected before discharge, as set forth in Regulation .07C(2) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The blood-spot specimen before the newborn is 7 days old if a newborn infant is discharged from a birthing facility before a newborn screening blood-spot specimen is collected.</text> </paragraph> <paragraph num="(3)"> <text>An additional blood-spot specimen within 7 days after notification if the laboratory reports to a birthing facility or a home birth attendant that the initial blood-spot specimen was unsatisfactory.</text> </paragraph> <paragraph num="(4)"> <text>A blood-spot specimen to be tested for hemoglobins, biotinidase, and galastose -1 phosphate uridyl transferase (GALT) only, four months after the last transfusion if the initial blood-spot specimen was not collected until after the infant was transfused.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Follow-Up Procedures."> <paragraph num="A."> <text>Department's Responsibilities.</text> <paragraph num="(1)"> <text>The Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly regarding:</text> <paragraph num="(a)"> <text>Results of first-tier, supplemental, and second-tier tests;</text> </paragraph> <paragraph num="(b)"> <text>The importance of identifying and locating a newborn infant with test results indicative of increased risk for an hereditary or congenital disorder;</text> </paragraph> <paragraph num="(c)"> <text>The urgent need for follow-up; and</text> </paragraph> <paragraph num="(d)"> <text>The need to share newborn screening information between hospitals, healthcare providers, treatment centers, and laboratory personnel.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the parent or guardian fails to respond to the birthing facility, health care provider, or other responsible individual acting as set forth in §B(1) of this regulation, the individual in charge of the birthing facility or the individual’s designated representative, health care provider, or other responsible individual shall notify the Follow-Up Unit, which shall then try to notify the parent or guardian of the need for follow-up by using at least one of the following means, in the indicated order of priority:</text> <paragraph num="(a)"> <text>Telephone;</text> </paragraph> <paragraph num="(b)"> <text>Certified mail, if medically appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Public health nurse visit; or</text> </paragraph> <paragraph num="(d)"> <text>Law enforcement contact.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Follow-Up Unit shall provide recommendations to the responsible birthing facility, health care provider, and the parent or guardian, as appropriate, regarding the appropriate follow-up and diagnostic evaluation of the newborn infant.</text> </paragraph> <paragraph num="(4)"> <text>The Follow-Up Unit shall recommend:</text> <paragraph num="(a)"> <text>Sources of diagnostic evaluation, specialty care, and treatment; and</text> </paragraph> <paragraph num="(b)"> <text>That no treatment be administered to the newborn infant until the results of the follow-up evaluation have established that the infant has a hereditary or congenital disorder.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The Follow-Up Unit shall inform health care personnel and parents or guardians of:</text> <paragraph num="(a)"> <text>The nature, cost, benefits, and risks of any therapy; and</text> </paragraph> <paragraph num="(b)"> <text>The availability of any programs to assist individuals affected by a hereditary or congenital disorder.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Responsibilities of the Birthing Facility or Health Care Provider. The individual in charge of the birthing facility or individual’s designated representative or health care provider shall:</text> <paragraph num="(1)"> <text>Evaluate the infant for signs, symptoms, and biochemical evidence of a hereditary or congenital disorder;</text> </paragraph> <paragraph num="(2)"> <text>Refer the newborn infant for further evaluation:</text> <paragraph num="(a)"> <text>To the appropriate specialists; and</text> </paragraph> <paragraph num="(b)"> <text>For the appropriate diagnostic tests;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Collect and submit any required blood-spot specimens for repeat screening or diagnostic testing; and</text> </paragraph> <paragraph num="(4)"> <text>Report the results of diagnostic testing to the Follow-Up Unit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Records."> <paragraph num="A."> <text>The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.</text> </paragraph> <paragraph num="B."> <text>On request, a laboratory or health care provider shall make available to the Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Follow-Up Unit considers necessary to:</text> <paragraph num="(1)"> <text>Screen a newborn infant for hereditary and congenital disorders set forth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Carry out the State's Newborn Screening Program, including:</text> <paragraph num="(a)"> <text>Contacting the families and primary health care providers of newborn infants with newborn screening test results indicating a high risk of having a hereditary or congenital disorder;</text> </paragraph> <paragraph num="(b)"> <text>Providing recommendations regarding the appropriate follow-up and diagnostic evaluation of the newborn infant;</text> </paragraph> <paragraph num="(c)"> <text>Determining what follow-up evaluations and diagnostic tests were performed and on what date the evaluations and tests were performed;</text> </paragraph> <paragraph num="(d)"> <text>Determining if and on what date a diagnosis of a specific hereditary or congenital disorder in a newborn infant was made; and</text> </paragraph> <paragraph num="(e)"> <text>Determining if and on what date treatment and follow-up care have been initiated; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Ensure compliance with the pertinent regulations set forth in this chapter and in COMAR 10.10.13.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Information that the Department receives under this chapter is confidential and may only be used or disclosed:</text> <paragraph num="(1)"> <text>To provide services to the newborn infant and the infant's family;</text> </paragraph> <paragraph num="(2)"> <text>To study the relationships of the various factors determining the frequency and distribution of the disorders set forth in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>For State or federally mandated statistical reports; and</text> </paragraph> <paragraph num="(4)"> <text>To ensure that the information received by the Department is accurate and reliable.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-109, 13-111, and 13-601—13-605, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 24, 1975 (2:29 Md. R. 1738)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.39.01, Testing for Hereditary Metabolic Disorders in the Newborn Child, to COMAR 10.52.12, Screening for Treatable Disorders in the Newborn Child, effective November 20, 1994 (21:23 Md. R. 1934)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01— .12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations .01— .15, Newborn Screening, adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 24, 2017 (44:8 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454)</annotation> </annotations> </chapter> <chapter num="13" heading="Screening for Sickle-Cell Disease, Thalassemia, and Related Conditions" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: June 16, 1978 (5:12 Md. R. 968)</annotation> <annotation type="History" subtype="Administrative History">COMAR 10.39.02, Screening for Sickle Cell, Thalassemia, and Related Conditions, revised and recodified to COMAR 10.52.13, Screening for Sickle Cell Disease, Thalassemia, and Related Conditions, effective April 24, 1995 (22:8 Md. R. 596)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 repealed effective December 10, 2012 (39:24 Md. R. 1578)</annotation> </annotations> </chapter> <chapter num="14" heading="Screening for Neural Tube Defects in the Fetus" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1986 (13:25 Md. R. 2660)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.39.03 to COMAR 10.52.14 effective January 2, 1995 (21:26 Md. R. 2188)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed effective December 10, 2012 (39:24 Md. R. 1578)</annotation> </annotations> </chapter> <chapter num="15" heading="Screening for Critical Congenital Heart Disease (CCHD) in Newborns"> <regulation prefix="Regulation" num=".01" heading="Purpose and Scope."> <paragraph num="A."> <text>This chapter establishes Statewide screening protocols for critical congenital heart disease in newborn infants.</text> </paragraph> <paragraph num="B."> <text>This chapter identifies standards and requirements for the Department, birthing facilities, nurse midwives, and persons participating in newborn screening for critical congenital heart disease.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Attending clinician” means an individual who is:</text> <paragraph num="(a)"> <text>A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Responsible for the care of newborn infants, and is either:</text> <paragraph num="(i)"> <text>A certified nurse practitioner licensed by the Maryland Board of Nursing; or</text> </paragraph> <paragraph num="(ii)"> <text>A certified nurse midwife licensed by the Maryland Board of Nursing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Attending physician” means an individual who is:</text> <paragraph num="(a)"> <text>A health care provider as defined in Health-General Article, §5-601, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Responsible for the care of a newborn infant;</text> </paragraph> <paragraph num="(c)"> <text>Licensed to practice medicine in Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>Board-certified by a member board of the American Board of Medical Specialties or an approved specialty board of the American Osteopathic Association in a specialty that includes the care of newborn infants.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Authorized health care provider” means an individual:</text> <paragraph num="(a)"> <text>Who has received training in the screening protocol; and</text> </paragraph> <paragraph num="(b)"> <text>For whom the CCHD screening tests are within his or her professional scope of practice.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Birth Defects Reporting and Information System” means the mandated reporting, monitoring, and follow-up of infants with birth defects as described in Health General Article, §18-206, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>Birthing Facility.</text> <paragraph num="(a)"> <text>“Birthing facility” means a facility that provides care for women during labor and delivery, and their newborn infants.</text> </paragraph> <paragraph num="(b)"> <text>“Birthing facility” includes a:</text> <paragraph num="(i)"> <text>Unit of a hospital that is licensed and accredited to provide birthing services; or</text> </paragraph> <paragraph num="(ii)"> <text>Freestanding birthing center as defined in COMAR 10.05.02.01B.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“CCHD screening” means pulse oximetry testing.</text> </paragraph> <paragraph num="(7)"> <text>“Critical congenital heart disease (CCHD)” means a congenital heart defect that places an infant at significant risk of disability or death if not diagnosed soon after birth.</text> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Echocardiogram” means a test that uses ultrasound to provide an image of the heart.</text> </paragraph> <paragraph num="(10)"> <text>“Newborn infant” means an infant in the first 28 days of life who was born:</text> <paragraph num="(a)"> <text>In Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>On federal property within Maryland.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Newborn Screening Follow-Up Unit” means the unit in the Department that carries out the duties set forth in Regulation .07 of this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Web-based system” means the web-based database used by the Department to collect data for newborn infant screening follow-up.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Pre-Test Information and the Right to Refuse Screening."> <paragraph num="A."> <text>Before a newborn infant is screened for CCHD, a health care provider shall provide to the newborn infant's parent or guardian an explanation of CCHD screening that includes:</text> <paragraph num="(1)"> <text>Reasons for screening, including:</text> <paragraph num="(a)"> <text>The purpose and benefits of the screening; and</text> </paragraph> <paragraph num="(b)"> <text>The nature, risks, and consequences of not screening for CCHD.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A parent or guardian's right to refuse having the screening performed, including:</text> <paragraph num="(a)"> <text>Explaining any risk involved with the screening; and</text> </paragraph> <paragraph num="(b)"> <text>Providing a reasonable opportunity to refuse the screening.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Refusal of Screening.</text> <paragraph num="(1)"> <text>All newborn infants shall be screened for CCHD unless the parent or guardian refuses the screening.</text> </paragraph> <paragraph num="(2)"> <text>If a parent or guardian refuses screening, a provider may not perform CCHD screening on the infant.</text> </paragraph> <paragraph num="(3)"> <text>When a parent or guardian refuses screening, the birthing facility or nurse midwife shall:</text> <paragraph num="(a)"> <text>Document parent refusal in the medical record; and</text> </paragraph> <paragraph num="(b)"> <text>Enter this information into the web-based system in accordance with Regulation .05 in this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the parent or guardian of the newborn infant does not refuse the screening, the birthing facility or nurse midwife shall:</text> <paragraph num="(a)"> <text>Perform screening on the newborn infant; and</text> </paragraph> <paragraph num="(b)"> <text>Follow-up with results in accordance with Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Screening Procedures."> <paragraph num="A."> <text>An authorized health care provider shall perform the screening.</text> </paragraph> <paragraph num="B."> <text>Newborn Infants Receiving Routine Care.</text> <paragraph num="(1)"> <text>The birthing facility or nurse midwife shall:</text> <paragraph num="(a)"> <text>Perform screening on a newborn infant between 24 hours and 48 hours of life; or</text> </paragraph> <paragraph num="(b)"> <text>If unable to perform the screening, refer the infant to another authorized health care provider to perform the screening between 24 hours and 48 hours of life.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the newborn infant is discharged from a facility after 12 hours of life but before 24 hours of life, the birthing facility shall perform screening as late as is practical before the newborn infant is discharged from the birthing facility.</text> </paragraph> <paragraph num="(3)"> <text>If the newborn infant is discharged before 12 hours of life, the birthing facility shall refer the infant to another authorized health care provider to perform screening between 24 hours and 48 hours of life.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Newborn Infants in Special Care or Intensive Care. Birthing facilities shall develop protocols for screening infants in the special care or intensive care nurseries.</text> </paragraph> <paragraph num="D."> <text>Circumstances Where Screening Is Not Indicated. There may be instances where screening for CCHD is not indicated, including but not limited to instances where:</text> <paragraph num="(1)"> <text>The newborn infant’s clinical evaluation to date has included an echocardiogram which ruled out CCHD; or</text> </paragraph> <paragraph num="(2)"> <text>The newborn infant has confirmed CCHD based on prenatal or postnatal testing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Results."> <paragraph num="A."> <text>Recordation of Results.</text> <paragraph num="(1)"> <text>All screening results shall be recorded in the newborn infant’s medical record.</text> </paragraph> <paragraph num="(2)"> <text>All screening results shall be entered into the web-based system along with the following information:</text> <paragraph num="(a)"> <text>Newborn infant’s:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Date of birth;</text> </paragraph> <paragraph num="(iii)"> <text>Gender;</text> </paragraph> <paragraph num="(iv)"> <text>Place of birth; and</text> </paragraph> <paragraph num="(v)"> <text>Primary care physician after discharge; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Mother’s:</text> <paragraph num="(i)"> <text>Name; and</text> </paragraph> <paragraph num="(ii)"> <text>Date of birth.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Abnormal Screening Results.</text> <paragraph num="(1)"> <text>Abnormal screening results shall be reported by the authorized health care provider who conducted the screening to the attending physician or attending clinician immediately.</text> </paragraph> <paragraph num="(2)"> <text>A newborn infant shall be evaluated immediately by an attending physician in order to complete the recommended protocol.</text> </paragraph> <paragraph num="(3)"> <text>A newborn infant may not be discharged from care until:</text> <paragraph num="(a)"> <text>A cause for the abnormal screening result has been determined; or</text> </paragraph> <paragraph num="(b)"> <text>An echocardiogram has been performed, read, and determined not to indicate CCHD.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The birthing facility shall enter screening results into the web-based system as specified in §A(2) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>The birthing facility shall provide notification of abnormal results to the newborn infant’s:</text> <paragraph num="(a)"> <text>Parent or guardian; and</text> </paragraph> <paragraph num="(b)"> <text>Primary care provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Newborn Infants Not Screened.</text> <paragraph num="(1)"> <text>If a newborn infant is not screened secondary to discharge before 12 hours of life, the birthing facility or nurse midwife shall:</text> <paragraph num="(a)"> <text>Follow-up with the family to refer to an authorized health care provider for screening between 24 hours and 48 hours of life after:</text> <paragraph num="(i)"> <text>Discharge from the facility; or</text> </paragraph> <paragraph num="(ii)"> <text>A home birth; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Enter into the web-based system the:</text> <paragraph num="(i)"> <text>Identifying information specified in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Reason for not screening which shall be “early discharge”.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a newborn infant is not screened secondary to screening not being indicated, the birthing facility or nurse midwife shall enter into the web-based system:</text> <paragraph num="(a)"> <text>The identifying information specified in §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The reason for not screening which shall be “screening not indicated”; and</text> </paragraph> <paragraph num="(c)"> <text>A notation of the reason for the override.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a newborn infant is not screened secondary to parent or guardian refusal, the birthing facility or nurse midwife shall enter into the web-based system the:</text> <paragraph num="(a)"> <text>Information specified in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Reason for not screening which shall be entered as “parent refusal”.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Birthing Facility and Nurse Midwife Responsibilities."> <paragraph num="A."> <text>Birthing Facility Responsibilities. The birthing facility shall:</text> <paragraph num="(1)"> <text>Identify a clinical staff person as a contact for CCHD screening;</text> </paragraph> <paragraph num="(2)"> <text>Develop protocols to ensure that all newborn infants are offered screening;</text> </paragraph> <paragraph num="(3)"> <text>Develop protocols to ensure that all screening results are reported in accordance with Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that follow-up is performed for newborn infants not screened before hospital discharge; and</text> </paragraph> <paragraph num="(5)"> <text>Develop protocols that assure the timely evaluation and referral, if necessary, of newborn infants who have abnormal screening results including:</text> <paragraph num="(a)"> <text>Evaluation by the attending physician;</text> </paragraph> <paragraph num="(b)"> <text>Performance of an echocardiogram;</text> </paragraph> <paragraph num="(c)"> <text>Reading of the echocardiogram; and</text> </paragraph> <paragraph num="(d)"> <text>Referral of newborn infants for further evaluation when needed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Newborn Infants Born Outside a Birthing Facility. If the birth of a newborn infant occurs outside a birthing facility, the nurse midwife shall perform screening in accordance with Regulation .05 of this chapter or refer to an authorized health care provider for screening between 24 hours and 48 hours of life.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Department Responsibilities."> <text>The Newborn Screening Follow-Up Unit shall:</text> <paragraph num="A."> <text>Investigate each instance of abnormal screening results to determine the cause for the abnormal result;</text> </paragraph> <paragraph num="B."> <text>Enter newborn infants found to have CCHD into the Birth Defects Reporting and Information System;</text> </paragraph> <paragraph num="C."> <text>Provide condition-specific information and resources to the family; and</text> </paragraph> <paragraph num="D."> <text>Perform ongoing evaluation of CCHD screening in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Records."> <paragraph num="A."> <text>The screening of newborn infants pursuant to this chapter is a population-based public health surveillance program as defined under the Health Insurance Portability and Accountability Act of 1996.</text> </paragraph> <paragraph num="B."> <text>On request, a birthing facility or health care provider shall make available to the Newborn Screening Follow-Up Unit:</text> <paragraph num="(1)"> <text>Medical records;</text> </paragraph> <paragraph num="(2)"> <text>Records of laboratory tests; and</text> </paragraph> <paragraph num="(3)"> <text>Any other medical information the Newborn Screening Follow-Up Unit considers necessary to:</text> <paragraph num="(a)"> <text>Determine final outcomes of abnormal screening results; and</text> </paragraph> <paragraph num="(b)"> <text>Evaluate CCHD Screening activities in the State, including:</text> <paragraph num="(i)"> <text>Performance of follow-up evaluations and diagnostic tests;</text> </paragraph> <paragraph num="(ii)"> <text>Initiation of treatment when necessary; and</text> </paragraph> <paragraph num="(iii)"> <text>Surveillance of the accuracy and efficacy of the screening.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Information that the Department receives under this chapter is confidential and may only be used or disclosed:</text> <paragraph num="(1)"> <text>To provide services to the newborn infant and the infant's family;</text> </paragraph> <paragraph num="(2)"> <text>To study the relationships of the various factors determining the frequency and distribution of CCHD;</text> </paragraph> <paragraph num="(3)"> <text>For State or federally mandated statistical reports; and</text> </paragraph> <paragraph num="(4)"> <text>To ensure that the information received by the Department is accurate and reliable.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-109, 13-111, and 18-107(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective October 5, 2012 (39:22 Md. R. 1427); emergency status extended to June 1, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> </annotations> </chapter> <chapter num="16" heading="Insect Sting Emergency Treatment Program" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: January 16, 2001 (27:25 Md. R. 2282)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective December 8, 2016 (43:24 Md. R. 1350)</annotation> </annotations> </chapter> <chapter num="17" heading="Maryland Asthma Control Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>The purpose of this chapter is to facilitate the implementation of the Maryland Asthma Control Program, to the extent allowed by available funding, by providing guidelines for the administration of the Asthma Coalition in its advisory capacity to the Program.</text> </paragraph> <paragraph num="B."> <text>This chapter also authorizes the Maryland Asthma Control Program to obtain asthma-related data through an asthma data surveillance system.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asthma data surveillance” means the ongoing and systematic collection, analysis, and interpretation of asthma-related information for the purposes of planning, implementing, and evaluating public health interventions to:</text> <paragraph num="(a)"> <text>Prevent asthma;</text> </paragraph> <paragraph num="(b)"> <text>Improve asthma health outcomes, including rates of asthma-related emergency department admissions, hospital admissions, and mortality; and</text> </paragraph> <paragraph num="(c)"> <text>Decrease health disparities associated with asthma.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Coalition” means the Maryland Statewide Asthma Coalition established by the Director of the Asthma Control Program under Health-General Article, §13-1704, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Local asthma coalition” means an alliance of individuals representing personal or organizational interests whose purpose is to reduce asthma prevalence, severity, and health disparities within a particular region or jurisdiction in Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Maryland Asthma Plan” means a comprehensive strategy that provides cohesive direction, objectives, strategies, and action steps for the Coalition to use in addressing asthma in Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Program” means the Maryland Asthma Control Program, which is established under Health-General Article, §13-1702, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Establishment and Membership."> <paragraph num="A."> <text>The Maryland Statewide Asthma Coalition is established.</text> </paragraph> <paragraph num="B."> <text>The Coalition consists of members recruited by the Director of the Maryland Asthma Control Program from each of the following organizations:</text> <paragraph num="(1)"> <text>The Department;</text> </paragraph> <paragraph num="(2)"> <text>The American Lung Association of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>The Asthma and Allergy Foundation of America, Maryland-Greater Washington, D.C. Chapter;</text> </paragraph> <paragraph num="(4)"> <text>The Johns Hopkins Medical Institutions;</text> </paragraph> <paragraph num="(5)"> <text>The University of Maryland, School of Medicine;</text> </paragraph> <paragraph num="(6)"> <text>Representatives from local health departments or local asthma coalitions;</text> </paragraph> <paragraph num="(7)"> <text>Professional health care provider organizations;</text> </paragraph> <paragraph num="(8)"> <text>Other State agencies with expertise or an interest in asthma; and</text> </paragraph> <paragraph num="(9)"> <text>Any other interested professional and community groups with asthma expertise.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Quorum, Meetings, Compensation, and Staff."> <paragraph num="A."> <text>The members of the Coalition who are present at a meeting are a quorum to do business provided that at least eight members including one co-chair attend the meeting.</text> </paragraph> <paragraph num="B."> <text>The Coalition shall meet at least twice per year, at the times and places that a co-chair determines.</text> </paragraph> <paragraph num="C."> <text>A member of the Coalition:</text> <paragraph num="(1)"> <text>May not receive State-funded compensation; and</text> </paragraph> <paragraph num="(2)"> <text>Is not entitled to State-funded reimbursement for travel or other expenses related to serving as a Coalition member.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Coalition Co-Chairs.</text> <paragraph num="(1)"> <text>The Program Director or the Director's designee shall serve as a co-chair of the Coalition and designate the Program staff necessary to carry out this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The other co-chair shall be selected by a majority vote of a quorum of the Coalition.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Duties."> <text>The Coalition shall provide assistance to the Department in the development and implementation of the Program by:</text> <paragraph num="A."> <text>Advising the Department on asthma-related matters, including establishing priorities within the Maryland Asthma Plan, through maintaining and sharing expertise on asthma issues;</text> </paragraph> <paragraph num="B."> <text>Facilitating communication and networking opportunities, especially through local coalitions, groups with shared interest, and other State coalitions;</text> </paragraph> <paragraph num="C."> <text>Increasing asthma awareness throughout the State; and</text> </paragraph> <paragraph num="D."> <text>Monitoring progress in achieving the goals established within the Maryland Asthma Plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Asthma Data Surveillance System."> <paragraph num="A."> <text>The Program shall establish a State asthma data surveillance system that has the authority to access and request the submission of data related to asthma, including the submission of a uniform data set and any confidential, patient-identifying data, or information from the following sources:</text> <paragraph num="(1)"> <text>Vital Statistics Administration;</text> </paragraph> <paragraph num="(2)"> <text>Maryland Health Care Commission;</text> </paragraph> <paragraph num="(3)"> <text>Maryland Institute for Emergency Medical Services Systems (MIEMSS);</text> </paragraph> <paragraph num="(4)"> <text>Maryland Health Services Cost Review Commission;</text> </paragraph> <paragraph num="(5)"> <text>Maryland Medical Assistance Program; and</text> </paragraph> <paragraph num="(6)"> <text>Other data sources, as necessary.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A health care provider or facility shall release confidential patient-identifying data or information to the Program in accordance with this chapter.</text> </paragraph> <paragraph num="C."> <text>Any identifying data or information that the Program receives under §A or B of this regulation is confidential and may be used only for public health surveillance purposes.</text> </paragraph> <paragraph num="D."> <text>A health care provider or facility may not be held liable for releasing data or other information to the Program in accordance with this regulation.</text> </paragraph> <paragraph num="E."> <text>Except for confidential, patient-identifying medical information, the Program may publish and disseminate data or information that relates to the incidence, severity, or cost of asthma or related conditions if the Program considers the publication beneficial and in the public's interest. However, before the data or information relating to asthma is published or disseminated, the Program shall consult with any person or entity that is the source of the data the Program intends to use. The Program and the person or entity shall agree upon the manner in which the data is published or disseminated.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§13-1701—13-1706, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 31, 2006 (33:15 Md. R. 1281)</annotation> </annotations> </chapter> </subtitle> <subtitle num="53" heading="Board of Nursing — Electrology Practice Committee"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(2)"> <text>“CEU” means continuing education courses that have been approved by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Committee” means the Electrology Practice Committee of the Board.</text> </paragraph> <paragraph num="(4)"> <text>“CDC” means the Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="(5)"> <text>“Central Repository” means the Criminal Justice Information System (CJIS) Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(6)"> <text>“Clinical examination” means an examination approved by the Board and administered by the Electrology Practice Committee for testing the clinical competency of applicants for licensure.</text> </paragraph> <paragraph num="(7)"> <text>“Criminal history records check” means the performance of both a State criminal history check by the Central Repository and a national criminal history check by the Federal Bureau of Investigation (FBI).</text> </paragraph> <paragraph num="(8)"> <text>“Criminal history records information” means information provided by the criminal history records check regarding an applicant's criminal arrests, charges, and convictions and other dispositions of criminal charges.</text> </paragraph> <paragraph num="(9)"> <text>“MHEC” means the Maryland Higher Education Commission.</text> </paragraph> <paragraph num="(10)"> <text>“National theory exam” means an exam approved by the Board and the American Electrology Association.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, 8-303, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 43)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulations .01—.05 adopted effective June 26, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05, Standards of Practice, repealed and new Regulation .01 adopted under new chapter, Definitions, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 7, 2007 (34:9 Md. R. 825); July 2, 2018 (45:13 Md. R. 667); May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensure"> <regulation prefix="Regulation" num=".01" heading="General Provisions for Applications."> <paragraph num="A."> <text>An applicant shall submit:</text> <paragraph num="(1)"> <text>A completed application to the Board on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>To a criminal history records check (CHRC) in accordance with Health Occupations Article, §8–303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Written evidence satisfactory to the Board that the applicant has submitted to a CHRC as required under §A(2) of this regulation by submitting:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the FBI;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>Under §A(2) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>In an answer to a question on the Board’s application form; or</text> </paragraph> <paragraph num="(c)"> <text>From any other source; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under this section is incomplete or insufficient.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to complete the application and provide all information and documents required in §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board under §A of this regulation within 12 months from the date the application is received by the Board, then the application shall be considered abandoned and may be destroyed.</text> </paragraph> <paragraph num="D."> <text>Once an application is deemed abandoned under §C of this regulation, an individual seeking licensure shall submit a new application on the form required by the Board and meet all of the requirements for licensure and pay the required fees that are in effect at the time of re-application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Applicants for Licensure."> <paragraph num="A."> <text>An applicant for licensure in electrology shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Be a high school graduate or equivalent; and</text> </paragraph> <paragraph num="(4)"> <text>Have successfully completed an electrology program that is in:</text> <paragraph num="(a)"> <text>Maryland and approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>Another State, territory, or country that the Board determines is substantially equivalent to the program required by the Board in Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>To apply for a license, an applicant shall:</text> <paragraph num="(1)"> <text>Comply with all of the requirements under Regulation .01A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board:</text> <paragraph num="(a)"> <text>Evidence of compliance with §A of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Information required by Regulation .03 or .04 of this chapter as appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Any applicable fee as set by the Board in COMAR 10.53.12; and</text> </paragraph> <paragraph num="(d)"> <text>Any additional information required by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall issue a license to an applicant who meets the requirements for licensure.</text> </paragraph> <paragraph num="D."> <text>A license may not be issued until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure by Examination."> <paragraph num="A."> <text>An applicant for licensure by examination shall submit to the Board:</text> <paragraph num="(1)"> <text>A completed application;</text> </paragraph> <paragraph num="(2)"> <text>The fee for examination as set forth in COMAR 10.53.12 that includes the application and clinical exam fees;</text> </paragraph> <paragraph num="(3)"> <text>A certified copy of the applicant's birth certificate or other legal proof of age;</text> </paragraph> <paragraph num="(4)"> <text>A copy of:</text> <paragraph num="(a)"> <text>Proof of completion of high school or attainment of equivalent education; and</text> </paragraph> <paragraph num="(b)"> <text>A certificate of completion from each electrology instruction program attended, with verification of the number of hours completed in each theory and clinical training; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Written, verified evidence satisfactory to the Board that the applicant has completed the application for a criminal history records check by submitting the following:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the FBI.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant eligible for the clinical examination shall be given a timely appointment.</text> </paragraph> <paragraph num="C."> <text>An applicant eligible for the national theory exam will be notified by the Board as to when the applicant may schedule the theory exam.</text> </paragraph> <paragraph num="D."> <text>To be eligible for licensure, an applicant shall earn a score of:</text> <paragraph num="(1)"> <text>75 percent or higher on the theory examination; and</text> </paragraph> <paragraph num="(2)"> <text>75 percent or higher on the clinical examination.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A license may not be issued until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensure by Waiver."> <paragraph num="A."> <text>An applicant who is licensed in another state shall:</text> <paragraph num="(1)"> <text>Comply with all requirements under Regulation .01A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board:</text> <paragraph num="(a)"> <text>Verification of the license;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of successful examination in another state that was substantially equivalent to the examinations given in this State; and</text> </paragraph> <paragraph num="(c)"> <text>A certificate of completion from each electrology instruction program attended that was substantially equivalent to the program requirements in this State, with a transcript or verification of the number of hours completed in each theory and clinical training.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may waive the examinations if the applicant:</text> <paragraph num="(1)"> <text>Provides verified documentation that the applicant:</text> <paragraph num="(a)"> <text>Is licensed to practice electrology in another state after meeting requirements that are substantially equivalent to the requirements in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Became licensed in the other state after passing in that state, or any other state, examinations that are substantially equivalent to the examinations approved by the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Meets the qualifications otherwise set forth in Regulation .01 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in COMAR 10.53.12.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A license may not be issued until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Renewal of Licensure."> <paragraph num="A."> <text>A licensee otherwise entitled to be licensed shall renew a license for 2 years by submitting to the Board:</text> <paragraph num="(1)"> <text>A renewal application on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The applicable fee as set forth in COMAR 10.53.12; and</text> </paragraph> <paragraph num="(3)"> <text>Evidence acceptable to the Board of completion of the CEU requirement as set forth in COMAR 10.53.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On notification by the Board that a criminal history records check is required before renewal of licensure, a renewal applicant shall comply with all requirements under Regulation .01A of this chapter.</text> </paragraph> <paragraph num="C."> <text>After notification to the licensee at the address provided to the Board that a criminal history records check is required for renewal, the Board may not renew a license without written documentation that the applicant has submitted to a criminal history records check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place a license on inactive status if the licensee:</text> <paragraph num="(1)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A written request for inactive status; and</text> </paragraph> <paragraph num="(b)"> <text>The applicable one-time fee as set forth in COMAR 10.53.12; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fails to submit the number of CEUs required for renewal of licensure as set forth in COMAR 10.53.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall reactivate a license if:</text> <paragraph num="(1)"> <text>The license has been inactive for less than 5 years;</text> </paragraph> <paragraph num="(2)"> <text>The licensee is otherwise entitled to be licensed; and</text> </paragraph> <paragraph num="(3)"> <text>The licensee submits to the Board:</text> <paragraph num="(a)"> <text>A reactivation application on a form required by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of completion of 10 CEUs for each year before application;</text> </paragraph> <paragraph num="(c)"> <text>The renewal fee as set forth in COMAR 10.53.12; and</text> </paragraph> <paragraph num="(d)"> <text>Written, verified evidence that the applicant for reactivation of their license has completed an application for a criminal history records check by submitting the following:</text> <paragraph num="(i)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(ii)"> <text>All fees required by the Central Repository and the FBI.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A license may not be reactivated until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a license has been inactive for 5 years or more, the individual shall successfully take the Board-approved theory and clinical electrology examinations.</text> </paragraph> <paragraph num="E."> <text>While on inactive status an electrologist or electrology instructor is not authorized to practice or instruct and may not use the designation “Electrologist”, “Licensed Electrologist”, “Electrology Instructor”, “Licensed Electrology Instructor”, “L.E.”, or “L.E.I.”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Reinstatement of Licensure."> <paragraph num="A."> <text>The Board shall reinstate the license of an individual who has failed to renew licensure for less than 5 years for any reason if the individual:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed; and</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>An application for reinstatement on a form required by the Board within 5 years after the license expired;</text> </paragraph> <paragraph num="(b)"> <text>Evidence satisfactory to the Board of compliance with the CEU requirement; and</text> </paragraph> <paragraph num="(c)"> <text>Written, verified evidence that the renewal applicant has completed an application for a criminal history records check by submitting the following:</text> <paragraph num="(i)"> <text>Two sets of fingerprints, as required by the Central Repository and the FBI; and</text> </paragraph> <paragraph num="(ii)"> <text>All fees required by the Central Repository and the FBI.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A license may not be issued until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the criminal history records information; and</text> </paragraph> <paragraph num="(2)"> <text>Approved the application.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An electrology instructor license that has been inactive or lapsed may be reinstated if the electrologist is:</text> <paragraph num="(1)"> <text>Otherwise entitled to be licensed; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the requirements of Regulation .08B of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An electrologist or electrology instructor whose license has been expired for 5 years or more may become licensed if the individual meets the current requirements for initial licensure by examination.</text> </paragraph> <paragraph num="E."> <text>While the license is expired, the individual may not:</text> <paragraph num="(1)"> <text>Practice as an electrologist or electrology instructor; or</text> </paragraph> <paragraph num="(2)"> <text>Use the designation “Electrologist”, “Licensed Electrologist”, “Electrology Instructor”, “Licensed Electrology Instructor”, “L.E.”, or “L.E.I.”.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Licensure Exception."> <text>A license is not required for a student who is practicing electrology as part of an approved clinical electrology program.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Instructor Licensure."> <paragraph num="A."> <text>General Requirements. An electrologist applying for an electrology instructor's license shall:</text> <paragraph num="(1)"> <text>Be a licensed electrologist who has satisfied the requirements for licensure as set forth by this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Have practiced electrology actively for at least 5 years immediately before making application;</text> </paragraph> <paragraph num="(3)"> <text>Submit an application on a form required by the Board at least 6 weeks before the instructor's examination is administered;</text> </paragraph> <paragraph num="(4)"> <text>Pay an application fee as set forth in COMAR 10.53.12; and</text> </paragraph> <paragraph num="(5)"> <text>Pass an examination which consists of the following:</text> <paragraph num="(a)"> <text>Preparation of a unit plan;</text> </paragraph> <paragraph num="(b)"> <text>Preparation of two written lesson plans which shall:</text> <paragraph num="(i)"> <text>Be drawn from the unit plan; and</text> </paragraph> <paragraph num="(ii)"> <text>Emphasize, but not be limited to, clinical electrology; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Verbal presentation of one of the two written lesson plans submitted.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure Requirements. An electrologist applying for an electrology instructor’s license shall:</text> <paragraph num="(1)"> <text>Receive a score of 80 percent or higher on unit and lesson plans as determined by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Sit for the clinical examination at any time during the application process and demonstrate competency in all electrology modalities with a passing score of 80 percent or higher as determined by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An electrology instructor shall conspicuously display proof of licensure at the instructor’s site of instruction.</text> </paragraph> <paragraph num="D."> <text>An electrology instructor shall keep the Board informed of:</text> <paragraph num="(1)"> <text>The location of the site where instruction will be offered; and</text> </paragraph> <paragraph num="(2)"> <text>Any change in instruction site address.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, 8-303, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Chapter, Licensure, repealed effective August 30, 1993 (20:17 Md. R. 1346)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 under new chapter, Requirements for Licensure, adopted effective August 30, 1993 (20:17 Md. R. 1346)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05, Requirements for Licensure, repealed and new Regulations .01—.08 adopted under new chapter, Licensure, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D adopted effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D adopted effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C adopted effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 19, 2013 (40:16 Md. R. 1344)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 13, 2017 (44:3 Md. R. 189)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, C amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, C amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="03" heading="Electrology Examination"> <regulation prefix="Regulation" num=".01" heading="Theory and Clinical Examinations."> <paragraph num="A."> <text>The Board, upon the recommendation of the Electrology Practice Committee, shall approve an applicant to sit for the national theory Exam.</text> </paragraph> <paragraph num="B."> <text>The applicant, after being notified by the Board that they are eligible for the written national theory exam, shall schedule the time and date for taking the national theory Exam.</text> </paragraph> <paragraph num="C."> <text>The Board or the Board’s designee shall perform the clinical examination covering:</text> <paragraph num="(1)"> <text>Standard precautions;</text> </paragraph> <paragraph num="(2)"> <text>Sterilization;</text> </paragraph> <paragraph num="(3)"> <text>Electrology instruments and technique;</text> </paragraph> <paragraph num="(4)"> <text>General knowledge of electrology; and</text> </paragraph> <paragraph num="(5)"> <text>The Maryland Electrology Practice and Regulations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The passing score for the national theory and the clinical examinations is 75 percent.</text> </paragraph> <paragraph num="E."> <text>The Committee may make recommendations to the Board concerning the examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Reexamination."> <paragraph num="A."> <text>An applicant may retake a written examination or a failed section of a written examination after paying the reexamination fee established in COMAR 10.53.12.</text> </paragraph> <paragraph num="B."> <text>An applicant who fails the written examination two times may be re-examined if the applicant:</text> <paragraph num="(1)"> <text>Completes an education program in areas in which the applicant, as determined by the Board, has demonstrated insufficient knowledge;</text> </paragraph> <paragraph num="(2)"> <text>Retakes the theory examination and the clinical examination; and</text> </paragraph> <paragraph num="(3)"> <text>Pays the full examination fee as set forth in COMAR 10.53.12.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board or the Board’s designee may give reexaminations to applicants who fail the clinical examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examinations for Applicants with Special Needs."> <paragraph num="A."> <text>An applicant with a disability may request modifications in examination materials or procedures. The applicant shall:</text> <paragraph num="(1)"> <text>Make the request in writing at least 6 weeks before the examination date; and</text> </paragraph> <paragraph num="(2)"> <text>Include in the request:</text> <paragraph num="(a)"> <text>The applicant's name;</text> </paragraph> <paragraph num="(b)"> <text>The examination to be modified;</text> </paragraph> <paragraph num="(c)"> <text>A letter from the appropriate medical professional which:</text> <paragraph num="(i)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(ii)"> <text>Provides information describing the accommodations required; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A letter from the applicant's education program, indicating what modifications, if any, were granted by the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant may be required to attend a personal interview with the Committee for the purpose of clarification of information on the special accommodation application.</text> </paragraph> <paragraph num="C."> <text>The Board reserves the right to review each special accommodation application and evaluate each application on its individual merits.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Examination Misconduct."> <paragraph num="A."> <text>The Board may determine that an individual who subverts or attempts to subvert the licensing examinations has not passed the examinations.</text> </paragraph> <paragraph num="B."> <text>Conduct that subverts or attempts to subvert the licensing examinations includes, but is not limited to:</text> <paragraph num="(1)"> <text>Violating the security of the examination materials;</text> </paragraph> <paragraph num="(2)"> <text>Removing from the examination room any of the examination;</text> </paragraph> <paragraph num="(3)"> <text>Reproducing a portion of the licensing examination;</text> </paragraph> <paragraph num="(4)"> <text>Aiding in the reproduction of any portion of the licensing examination;</text> </paragraph> <paragraph num="(5)"> <text>Selling, distributing, buying, receiving, or having unauthorized possession of any portion of a future or current theory or clinical examination;</text> </paragraph> <paragraph num="(6)"> <text>Communicating with any other examinee during the administration of the theory or clinical examinations;</text> </paragraph> <paragraph num="(7)"> <text>Copying answers from another examinee or permitting one's answers to be copied by another examinee during the administration of the examination;</text> </paragraph> <paragraph num="(8)"> <text>Having in one’s possession during the administration of the theory or clinical examination any books, photographs, recording devices, notes, written or printed materials, or data of any kind other than the examination materials distributed; or</text> </paragraph> <paragraph num="(9)"> <text>Falsifying or misrepresenting education credentials or other information for admission to the theory or clinical examinations by impersonating an examinee.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Reinstatement of License, repealed and new Regulations .01—.04 adopted under new chapter, Electrology Examination, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 2, 2018 (45:13 Md. R. 667); May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="04" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Definition."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “One continuing education unit (CEU)” means 1 clock hour of participation in an organized continuing education experience that is:</text> <paragraph num="(1)"> <text>Related to the clinical practice of electrology;</text> </paragraph> <paragraph num="(2)"> <text>Obtained after original licensure is granted; and</text> </paragraph> <paragraph num="(3)"> <text>Approved by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Professional education eligible for continuing education credit shall be:</text> <paragraph num="(1)"> <text>Relevant to the clinical practice of electrology; and</text> </paragraph> <paragraph num="(2)"> <text>Directed to a professional audience.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall have final approval of the relevancy of the program to the practice of electrology.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Continuing Education Requirements."> <paragraph num="A."> <text>A licensed electrologist shall:</text> <paragraph num="(1)"> <text>Complete 10 clock hours of Board-approved CEUs by October 28 of each year of licensure; and</text> </paragraph> <paragraph num="(2)"> <text>Provide proof of completion to the Board upon renewal of licensure.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CEUs earned in one renewal period may not be carried over to the next license renewal period.</text> </paragraph> <paragraph num="C."> <text>An individual seeking reinstatement of a license expired for less than 5 years shall provide evidence of 10 clock hours of Board-approved CEUs for each year the license was expired.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Continuing Education Unit."> <paragraph num="A."> <text>One CEU is equivalent to 1 hour of education.</text> </paragraph> <paragraph num="B."> <text>More than one course may be taken to fulfill the CEU requirement.</text> </paragraph> <paragraph num="C."> <text>One semester credit hour at an approved university or college as required in Regulation .04 of this chapter taken for credit or audit is equivalent to 10 CEUs.</text> </paragraph> <paragraph num="D."> <text>The total number of CEUs required is prorated for an individual for whom one of the following actions takes place within a renewal period:</text> <paragraph num="(1)"> <text>Issuance of an original license;</text> </paragraph> <paragraph num="(2)"> <text>Reactivation of a license; or</text> </paragraph> <paragraph num="(3)"> <text>Reinstatement of a license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>CEUs may be obtained for the 2-year period, up to the maximum specified as follows:</text> <paragraph num="(1)"> <text>6 CEUs in business management;</text> </paragraph> <paragraph num="(2)"> <text>3 CEUs in CPR;</text> </paragraph> <paragraph num="(3)"> <text>3 CEUs in First Aid;</text> </paragraph> <paragraph num="(4)"> <text>6 CEUs by home study;</text> </paragraph> <paragraph num="(5)"> <text>8 CEUs for each preparation and delivery of a lecture or published article; and</text> </paragraph> <paragraph num="(6)"> <text>Any education earned under Regulation .04 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Approval of Courses."> <paragraph num="A."> <text>The Board shall approve a course, seminar, or speaker session if it is:</text> <paragraph num="(1)"> <text>Relevant to the practice of electrology; and</text> </paragraph> <paragraph num="(2)"> <text>Offered by a:</text> <paragraph num="(a)"> <text>College or university approved by MHEC;</text> </paragraph> <paragraph num="(b)"> <text>State or national professional electrology association;</text> </paragraph> <paragraph num="(c)"> <text>Board-approved electrology program;</text> </paragraph> <paragraph num="(d)"> <text>Health department or hospital;</text> </paragraph> <paragraph num="(e)"> <text>American Red Cross; or</text> </paragraph> <paragraph num="(f)"> <text>American Heart Association.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Requests for Approval.</text> <paragraph num="(1)"> <text>If a course is not listed in §A of this regulation, an electrologist may request that the Board approve the course by submitting, in writing, at least 2 months before the course registration date, the following information on an application provided by the Board:</text> <paragraph num="(a)"> <text>Title, location, and date of the course;</text> </paragraph> <paragraph num="(b)"> <text>Sponsors;</text> </paragraph> <paragraph num="(c)"> <text>Course objectives and contents;</text> </paragraph> <paragraph num="(d)"> <text>Hours of study;</text> </paragraph> <paragraph num="(e)"> <text>Name, qualifications, and curriculum vitae of each presenter; and</text> </paragraph> <paragraph num="(f)"> <text>The specific information that relates to the CEU.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEU Credit for Renewal.</text> <paragraph num="(a)"> <text>CEUs shall be completed within the renewal period for which they are submitted between October 29th of the previous renewal period and October 28th of the present renewal period.</text> </paragraph> <paragraph num="(b)"> <text>CEUs do not carry over to the next renewal period.</text> </paragraph> <paragraph num="(c)"> <text>Credit will not be given for any CEU under §B(1) of this regulation unless the Board approves the program before the licensee attends an event.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board shall notify the applicant of the Board's decision.</text> </paragraph> <paragraph num="(4)"> <text>An application for reapproval shall be made if there is a change of subject matter, length, or presenter of a course.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01G adopted effective March 14, 1994 (21:5 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Electrologists' Office, repealed and new Regulations .01—.04 adopted under new chapter, Continuing Education, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C, D adopted effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 19, 2013 (40:16 Md. R. 1344)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended as an emergency provision effective August 18, 2011 (38:19 Md. R. 1146); amended permanently effective October 17, 2011 (38:21 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective August 19, 2013 (40:16 Md. R. 1344)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective August 19, 2013 (40:16 Md. R. 1344)</annotation> </annotations> </chapter> <chapter num="05" heading="Standards of Practice and Conduct"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Electronic devices” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephones with recording and picture-taking ability</text> </paragraph> <paragraph num="(b)"> <text>Digital cameras or any other device that can record pictures and data;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machines, photocopiers, and scanners for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Recording devices.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Social media” means any form of electronic communication, including, but not limited to, communication by use of websites for social networking and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Standards of Practice."> <paragraph num="A."> <text>An electrologist shall be primarily concerned with the welfare of the patient.</text> </paragraph> <paragraph num="B."> <text>An electrologist shall seek professional treatment and refrain from the practice of electrology, if the electrologist suffers from a physical, mental, emotional, or chemical impairment which negatively impacts the electrologist's ability to practice electrology.</text> </paragraph> <paragraph num="C."> <text>An electrologist shall:</text> <paragraph num="(1)"> <text>Use professional discretion and integrity in relationships with other members of the health care community;</text> </paragraph> <paragraph num="(2)"> <text>Engage in professional conduct at all times, with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Remain free from conflicts of interest, fulfill the objectives, and maintain the integrity of the electrology profession;</text> </paragraph> <paragraph num="(4)"> <text>Provide accurate fee information to:</text> <paragraph num="(a)"> <text>Patients;</text> </paragraph> <paragraph num="(b)"> <text>Individuals responsible for payment for treatment; and</text> </paragraph> <paragraph num="(c)"> <text>Insurers;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Respect a patient's dignity, autonomy, and privacy; and</text> </paragraph> <paragraph num="(6)"> <text>Practice electrology only as defined in the scope of practice set forth in Health Occupations Article, Title 8, Annotated Code of Maryland, and remain in compliance with all federal, State, and local laws governing the practice of electrology.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Relationships with Patients. An electrologist shall:</text> <paragraph num="(1)"> <text>Use professional judgment in evaluation and treatment procedures;</text> </paragraph> <paragraph num="(2)"> <text>Make a full disclosure to each patient who cannot reasonably be expected to benefit from treatment;</text> </paragraph> <paragraph num="(3)"> <text>Terminate a professional relationship with a patient in an appropriate manner;</text> </paragraph> <paragraph num="(4)"> <text>Upon termination:</text> <paragraph num="(a)"> <text>Provide the patient with sufficient notice to permit the patient to obtain the services of another professional; and</text> </paragraph> <paragraph num="(b)"> <text>If appropriate, assist the patient by providing referrals;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintain written records of a patient under the electrologist's care for at least 7 years after termination of treatment;</text> </paragraph> <paragraph num="(6)"> <text>Make a patient's records available to the patient upon request, complying with applicable laws for disclosure of medical records;</text> </paragraph> <paragraph num="(7)"> <text>Arrange for another professional to provide for the needs of patients during anticipated absences when the electrologist would be unavailable to patients;</text> </paragraph> <paragraph num="(8)"> <text>Accurately inform patients, other health care professionals, and the public of the limitations of the practice of electrology;</text> </paragraph> <paragraph num="(9)"> <text>Adequately assess each patient before beginning treatment to determine if contraindications against treatment exist; and</text> </paragraph> <paragraph num="(10)"> <text>Exercise independent professional judgment in the treatment or evaluation, or both, of patients, regardless of whether the patient was referred by another health care provider.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Records, Confidentiality, and Informed Consent. An electrologist shall:</text> <paragraph num="(1)"> <text>Respect and maintain the privacy and confidentiality of each patient;</text> </paragraph> <paragraph num="(2)"> <text>Disclose patient records or information about a patient only with the patient's consent or as required by law;</text> </paragraph> <paragraph num="(3)"> <text>Adequately safeguard confidential patient information, and properly store and dispose of records;</text> </paragraph> <paragraph num="(4)"> <text>Provide sufficient information to a patient to allow the patient to make informed decisions regarding treatment, including:</text> <paragraph num="(a)"> <text>The purpose and nature of any evaluation or treatment regimen;</text> </paragraph> <paragraph num="(b)"> <text>Alternatives to treatment;</text> </paragraph> <paragraph num="(c)"> <text>Side effects and benefits of any treatment regimen proposed and alternatives to that treatment;</text> </paragraph> <paragraph num="(d)"> <text>The estimated cost of treatment;</text> </paragraph> <paragraph num="(e)"> <text>The right of the patient to withdraw from treatment at any time, as well as the risks associated with withdrawing from treatment;</text> </paragraph> <paragraph num="(f)"> <text>The patient's right to decline to participate in treatment if any aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in any educational or other program; and</text> </paragraph> <paragraph num="(g)"> <text>Participating in research programs only if the programs comply with federal and State laws and only under the following conditions:</text> <paragraph num="(i)"> <text>Informed consent of the patient is obtained;</text> </paragraph> <paragraph num="(ii)"> <text>There is no direct or implied penalty for the patient's refusal to participate; and</text> </paragraph> <paragraph num="(iii)"> <text>The patient's autonomy and dignity are respected.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Treatment.</text> <paragraph num="(1)"> <text>An electrologist may not perform treatments or provide services which:</text> <paragraph num="(a)"> <text>The electrologist is not qualified to perform; or</text> </paragraph> <paragraph num="(b)"> <text>Are beyond the scope of the electrologist's education, training, capabilities, experience, and scope of practice.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An electrologist shall obtain additional training, information, and supervision as needed:</text> <paragraph num="(a)"> <text>To perform a new electrology technique or service in a new specialty area; or</text> </paragraph> <paragraph num="(b)"> <text>To employ a new treatment modality.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An electrologist shall maintain current licensure to practice electrology and satisfy continuing education requirements established by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Unprofessional Conduct."> <paragraph num="A."> <text>It is unprofessional conduct to:</text> <paragraph num="(1)"> <text>Fail to cooperate with a lawful investigation of the Board by failing to:</text> <paragraph num="(a)"> <text>Furnish information requested;</text> </paragraph> <paragraph num="(b)"> <text>Comply with a subpoena;</text> </paragraph> <paragraph num="(c)"> <text>Respond to complaints at the request of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Provide meaningful and timely access to relevant patient records;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Misrepresent professional credentials, qualifications, education, or affiliations;</text> </paragraph> <paragraph num="(3)"> <text>Fail to attempt to correct others who misrepresent the electrologist's credentials, qualifications, education, or affiliations;</text> </paragraph> <paragraph num="(4)"> <text>Engage in or condone conduct in the practice of electrology, which:</text> <paragraph num="(a)"> <text>Is fraudulent;</text> </paragraph> <paragraph num="(b)"> <text>Is dishonest;</text> </paragraph> <paragraph num="(c)"> <text>Is deceitful; or</text> </paragraph> <paragraph num="(d)"> <text>Involves moral turpitude;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Engage in commercial activities which conflict with the electrologist's duties as an electrologist;</text> </paragraph> <paragraph num="(6)"> <text>Perform electrolysis on a patient if there is a contraindication against electrolysis treatment; and</text> </paragraph> <paragraph num="(7)"> <text>Discriminate against a patient or health care provider based on:</text> <paragraph num="(a)"> <text>Race;</text> </paragraph> <paragraph num="(b)"> <text>Religion;</text> </paragraph> <paragraph num="(c)"> <text>Age;</text> </paragraph> <paragraph num="(d)"> <text>Gender;</text> </paragraph> <paragraph num="(e)"> <text>Sexual orientation;</text> </paragraph> <paragraph num="(f)"> <text>National origin; or</text> </paragraph> <paragraph num="(g)"> <text>Human Immunodeficiency Virus (HIV) status.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An electrologist may not:</text> <paragraph num="(1)"> <text>Accept a patient for treatment, or continue treatment, if the patient cannot reasonably be expected to benefit from the treatment;</text> </paragraph> <paragraph num="(2)"> <text>Receive remuneration from or split a fee for either making or accepting referrals of the patient to another health care practitioner;</text> </paragraph> <paragraph num="(3)"> <text>Unless supported by scientific principles accepted by the profession, make guarantees or promises concerning the efficacy of:</text> <paragraph num="(a)"> <text>A particular treatment in general;</text> </paragraph> <paragraph num="(b)"> <text>The electrologist's practice in particular; or</text> </paragraph> <paragraph num="(c)"> <text>A prognosis;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Continue treatment unnecessarily; or</text> </paragraph> <paragraph num="(5)"> <text>Charge for services:</text> <paragraph num="(a)"> <text>Not provided; or</text> </paragraph> <paragraph num="(b)"> <text>Different from those actually provided.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Professional Boundaries.</text> <paragraph num="(1)"> <text>The electrologist has the ethical and professional obligation to maintain professional boundaries, even if the patient initiates crossing the boundaries of the professional relationship. The electrologist shall respect and maintain professional boundaries.</text> </paragraph> <paragraph num="(2)"> <text>The electrologist may not use a relationship with a patient for the electrologist's advantage, including but not limited to personal, sexual, romantic, and financial relationships.</text> </paragraph> <paragraph num="(3)"> <text>An electrologist may not engage in sexual or other inappropriate acts with a patient. Sexual misconduct includes, but is not limited to, sexual behavior with a patient in the context of a professional evaluation, treatment, procedure, or other service to the patient, regardless of the setting where the professional service is provided.</text> </paragraph> <paragraph num="(4)"> <text>If an electrologist and a patient mutually desire a personal relationship, the electrologist shall:</text> <paragraph num="(a)"> <text>Immediately terminate the professional relationship;</text> </paragraph> <paragraph num="(b)"> <text>Make an appropriate referral to another health care practitioner; and</text> </paragraph> <paragraph num="(c)"> <text>Wait an appropriate period of time before engaging in the relationship so that it is reasonably certain that the former professional relationship does not influence the personal relationship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Electronic devices including, but not limited to telephones, may not be used to take pictures or videos of clients without written client authorization.</text> </paragraph> <paragraph num="E."> <text>An electrologist:</text> <paragraph num="(1)"> <text>May not make use of electronic devices and social media to transmit or place any client information online; and</text> </paragraph> <paragraph num="(2)"> <text>Shall adhere to the following principles for the use of electronic devices and social media:</text> <paragraph num="(a)"> <text>Every electrologist has an obligation to understand the nature, benefits, and consequences of using electronic devices and participating in social media networking;</text> </paragraph> <paragraph num="(b)"> <text>An electrologist is bound to observe ethically prescribed client-electrologist boundaries when using electronic devices and social media as in any other setting;</text> </paragraph> <paragraph num="(c)"> <text>Client information shall be maintained in separate encrypted and secured files on personal computers and online; and</text> </paragraph> <paragraph num="(d)"> <text>The standards of professionalism are the same when using electronic devices and social media as in any other circumstance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>An electrologist may not engage in behavior that dishonors the profession whether or not acting in the capacity of a licensed electrologist, including, but not limited to:</text> <paragraph num="(1)"> <text>Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample;</text> </paragraph> <paragraph num="(2)"> <text>Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug; or</text> </paragraph> <paragraph num="(3)"> <text>Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Penalties."> <text>Violation of this chapter may result in disciplinary action pursuant to Health Occupations Article, §8-6B-18, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health General Article, §4-403; Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-01—8-6B-29; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01J, O, P amended and Y adopted effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01Y amended effective March 14, 1994 (21:5 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Instruments and Procedures, repealed and new Regulations .01—.03 adopted under new chapter, Standards of Practice and Conduct, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 11, 2014 (41:24 Md. R. 1428)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .0E amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="06" heading="Electrology Programs"> <regulation prefix="Regulation" num=".01" heading="Application for Approval."> <paragraph num="A."> <text>An institution shall be approved by the Board before initiating an electrology program.</text> </paragraph> <paragraph num="B."> <text>An institution seeking approval of an educational program shall submit to the Board:</text> <paragraph num="(1)"> <text>A completed application on a form required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the curriculum and course outline:</text> <paragraph num="(a)"> <text>Describing how the program meets the requirements of Regulations .04 and .05 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Providing for at least 600 hours of instruction;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A copy of the course catalog; and</text> </paragraph> <paragraph num="(4)"> <text>Evidence of approval by MHEC.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall notify the educational program of its decision within 60 days of the day a completed application is received by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Enrollment."> <text>At the time of enrollment, an institution shall:</text> <paragraph num="A."> <text>Provide each student with a copy of the Maryland Electrologists Act and the regulations under this subtitle;</text> </paragraph> <paragraph num="B."> <text>Provide each student with a copy of the course outline;</text> </paragraph> <paragraph num="C."> <text>Require the student to provide evidence of an eye examination and successful correction of any visual deficiency; and</text> </paragraph> <paragraph num="D."> <text>Have available a sufficient supply of approved textbooks.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Theory Program."> <paragraph num="A."> <text>A theory program shall:</text> <paragraph num="(1)"> <text>Be taught by a licensed electrology instructor;</text> </paragraph> <paragraph num="(2)"> <text>Consist of at least 200 hours; and</text> </paragraph> <paragraph num="(3)"> <text>Administer the theoretical study in not less than five sessions consisting of not more than 6 hours in each of the following subjects:</text> <paragraph num="(a)"> <text>Introduction, which shall include:</text> <paragraph num="(i)"> <text>The history and definition of electrology; and</text> </paragraph> <paragraph num="(ii)"> <text>State laws and regulations governing the practice of electrology and requirements for licensure;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Anatomy of skin and hair;</text> </paragraph> <paragraph num="(c)"> <text>Physiology of skin and hair;</text> </paragraph> <paragraph num="(d)"> <text>Bacteriology;</text> </paragraph> <paragraph num="(e)"> <text>Sanitation, disinfection, and sterilization procedures as described in COMAR 10.53.09;</text> </paragraph> <paragraph num="(f)"> <text>Dermatology;</text> </paragraph> <paragraph num="(g)"> <text>Neurology;</text> </paragraph> <paragraph num="(h)"> <text>Cardiovascular system;</text> </paragraph> <paragraph num="(i)"> <text>Endocrine system, with emphasis on adrenal glands and ovaries;</text> </paragraph> <paragraph num="(j)"> <text>Hirsutism, including causes, testing, and treatment;</text> </paragraph> <paragraph num="(k)"> <text>Alternative methods of hair removal;</text> </paragraph> <paragraph num="(l)"> <text>Contraindications for electrolysis treatments;</text> </paragraph> <paragraph num="(m)"> <text>Taking patient history; and</text> </paragraph> <paragraph num="(n)"> <text>Professional ethics as set forth in COMAR 10.53.05.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Members of the Committee shall be permitted to monitor the course at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Clinical Program."> <paragraph num="A."> <text>A clinical program shall:</text> <paragraph num="(1)"> <text>Be taught by a licensed electrology instructor;</text> </paragraph> <paragraph num="(2)"> <text>Consist of at least 400 hours;</text> </paragraph> <paragraph num="(3)"> <text>Administer the clinical training in a semester consisting of not less than 3 months; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that each day of clinical study consists of not more than:</text> <paragraph num="(a)"> <text>6 hours of training; or</text> </paragraph> <paragraph num="(b)"> <text>2 hours of training if on the same day as theory instruction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>There shall be at least one licensed instructor in attendance at all times for ten students or less. A student may not be assigned in any capacity to instruct another student.</text> </paragraph> <paragraph num="C."> <text>The curriculum shall include:</text> <paragraph num="(1)"> <text>Introduction, which shall include:</text> <paragraph num="(a)"> <text>The definition of electrology; and</text> </paragraph> <paragraph num="(b)"> <text>State laws and regulations governing the practice of electrology and requirements for licensure;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Professional ethics as set forth in COMAR 10.53.05;</text> </paragraph> <paragraph num="(3)"> <text>Case history and record keeping;</text> </paragraph> <paragraph num="(4)"> <text>Consultation;</text> </paragraph> <paragraph num="(5)"> <text>Electrolysis, thermolysis, and the blend;</text> </paragraph> <paragraph num="(6)"> <text>Electricity;</text> </paragraph> <paragraph num="(7)"> <text>Needle types and performance;</text> </paragraph> <paragraph num="(8)"> <text>Sanitation, disinfection, and sterilization procedures as described in COMAR 10.53.09;</text> </paragraph> <paragraph num="(9)"> <text>Structure and dynamics of hair;</text> </paragraph> <paragraph num="(10)"> <text>Regrowth;</text> </paragraph> <paragraph num="(11)"> <text>Interpretation of hair growth patterns;</text> </paragraph> <paragraph num="(12)"> <text>Evaluation of tissue before, during, and after treatment;</text> </paragraph> <paragraph num="(13)"> <text>Draping, positioning, and lighting;</text> </paragraph> <paragraph num="(14)"> <text>Post-treatment;</text> </paragraph> <paragraph num="(15)"> <text>Insertions and epilations;</text> </paragraph> <paragraph num="(16)"> <text>Adverse reactions and contraindications of all hair removal methods;</text> </paragraph> <paragraph num="(17)"> <text>Normal and abnormal healing;</text> </paragraph> <paragraph num="(18)"> <text>Scheduling of appropriate follow-up treatments;</text> </paragraph> <paragraph num="(19)"> <text>Developing a practice; and</text> </paragraph> <paragraph num="(20)"> <text>Review of theory and clinical studies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An electrology program shall be taught in a facility that complies with Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physical Facilities and Equipment."> <paragraph num="A."> <text>A program facility shall be sufficient to accommodate the student body, lecturers, and clinical demonstrations.</text> </paragraph> <paragraph num="B."> <text>A program facility shall be adequately lighted, well-ventilated, and in sanitary condition at all times.</text> </paragraph> <paragraph num="C."> <text>A sink with hot and cold running water shall be in or adjoining each treatment room for proper hand washing.</text> </paragraph> <paragraph num="D."> <text>Epilators (electrolysis, thermolysis, and the blend) shall be of the type approved by the FCC and registered with the FDA.</text> </paragraph> <paragraph num="E."> <text>A program facility shall provide modern professional equipment and provide and maintain the following for its students:</text> <paragraph num="(1)"> <text>One approved epilator for every four students;</text> </paragraph> <paragraph num="(2)"> <text>One professional table and adjustable stool for every four students;</text> </paragraph> <paragraph num="(3)"> <text>One professional lamp for every four students;</text> </paragraph> <paragraph num="(4)"> <text>One dry heat or autoclave unit for sterilization; and</text> </paragraph> <paragraph num="(5)"> <text>Adequate supplies.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A facility shall display in a conspicuous place a sign, consisting of at least 2-inch letters, that states “ALL ELECTROLOGY TREATMENTS PERFORMED IN THIS FACILITY ARE PERFORMED BY STUDENTS”.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Student Clinical Practice."> <paragraph num="A."> <text>Before a student renders treatment, a patient shall be required to sign an informed consent agreement.</text> </paragraph> <paragraph num="B."> <text>Clinical services may be performed by students only:</text> <paragraph num="(1)"> <text>Within the facility; and</text> </paragraph> <paragraph num="(2)"> <text>Under the direct supervision of a licensed instructor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A program facility may charge a fee for treatment rendered by a student to cover the cost of supplies only.</text> </paragraph> <paragraph num="D."> <text>Members of the Committee shall be permitted to inspect the program facility at any time or request the program to complete an Institutional review report at any time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Reporting."> <paragraph num="A."> <text>An educational program shall:</text> <paragraph num="(1)"> <text>Keep a record of each student’s:</text> <paragraph num="(a)"> <text>Application;</text> </paragraph> <paragraph num="(b)"> <text>Current address and telephone number;</text> </paragraph> <paragraph num="(c)"> <text>Date of enrollment;</text> </paragraph> <paragraph num="(d)"> <text>Attendance;</text> </paragraph> <paragraph num="(e)"> <text>Number of hours completed; and</text> </paragraph> <paragraph num="(f)"> <text>Grades achieved; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Make the record available to the Board at the Board's request.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A program shall submit to the Board for approval any changes made to an approved program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Violations."> <text>The Board may remove approval from an electrology program if the program:</text> <paragraph num="A."> <text>Is guilty of fraud or deceit in obtaining or attempting to obtain approval;</text> </paragraph> <paragraph num="B."> <text>Acts in a manner inconsistent with generally accepted standards for the practice of electrology;</text> </paragraph> <paragraph num="C."> <text>Advertises in a manner that the Board determines violates Health Occupations Article, §8-6B-23, Annotated Code of Maryland;</text> </paragraph> <paragraph num="D."> <text>Violates the standards set under Health Occupations Article, §8-6B-23, Annotated Code of Maryland, if the program:</text> <paragraph num="(1)"> <text>Receives a notice of deficiency; and</text> </paragraph> <paragraph num="(2)"> <text>Fails to correct a deficiency within a time period set by the notice of deficiency; or</text> </paragraph> </paragraph> <paragraph num="E."> <text>No longer operates a program that qualifies for approval under Health Occupations Article, §8-6B-16, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 44)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B—D amended and .01G—J adopted effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01K adopted effective March 14, 1994 (21:5 Md. R. 404)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Sterilization Procedures, repealed and new Regulations .01—.08 adopted under new chapter, Electrology Programs, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, D amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="07" heading="Electrologist's Office"> <regulation prefix="Regulation" num=".01" heading="Electrologist's Office."> <paragraph num="A."> <text>A licensee shall practice in an office that provides at minimum the following:</text> <paragraph num="(1)"> <text>Separate treatment and waiting room;</text> </paragraph> <paragraph num="(2)"> <text>Each treatment room at least 48 square feet;</text> </paragraph> <paragraph num="(3)"> <text>One sink with hot and cold running water in or adjoining each treatment room;</text> </paragraph> <paragraph num="(4)"> <text>Adequate lighting;</text> </paragraph> <paragraph num="(5)"> <text>Adequate ventilation;</text> </paragraph> <paragraph num="(6)"> <text>Sanitary conditions;</text> </paragraph> <paragraph num="(7)"> <text>Toilet facilities;</text> </paragraph> <paragraph num="(8)"> <text>Separate outside entrance leading directly to the waiting room if the office is within or adjacent to living quarters; and</text> </paragraph> <paragraph num="(9)"> <text>A completely separate and distinct office area from the living quarters.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Offices maintained in a home shall comply with all local zoning laws. A copy of the zoning approval shall be submitted to the Board 30 days before opening an office in a residence.</text> </paragraph> <paragraph num="C."> <text>Electrologists shall notify the Board by certified mail 30 days before opening an office or branch office.</text> </paragraph> <paragraph num="D."> <text>Electrologists shall notify the Board in writing of their business address or any change of business address.</text> </paragraph> <paragraph num="E."> <text>An office shall be made available for inspection within 4 hours notice, by members of the Board or its agents.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 45)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective September 3, 1990 (17:17 Md. R. 2081)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05, Advertising, repealed and new Regulation .01 adopted under new chapter, Electrologist's Office, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="08" heading="Instruments and Procedures"> <regulation prefix="Regulation" num=".01" heading="Equipment."> <paragraph num="A."> <text>Electrologists shall use only Board-approved modalities which are:</text> <paragraph num="(1)"> <text>Electrolysis;</text> </paragraph> <paragraph num="(2)"> <text>Thermolysis; or</text> </paragraph> <paragraph num="(3)"> <text>The blend.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Electronic tweezer or nonneedle methods are not defined as within the practice of electrology.</text> </paragraph> <paragraph num="C."> <text>Epilators shall be approved by the Federal Communications Commission (FCC) and conform to federal Food and Drug Administration (FDA) standards relating to these devices.</text> </paragraph> <paragraph num="D."> <text>Epilators shall be maintained in proper working condition.</text> </paragraph> <paragraph num="E."> <text>Optimum timing and intensity shall be used during treatment to effect proper epilation of hair and to avoid tweezing.</text> </paragraph> <paragraph num="F."> <text>A professional lamp and magnification shall be used to view area during treatment.</text> </paragraph> <paragraph num="G."> <text>A professional treatment table or chair shall be used to administer treatments.</text> </paragraph> <paragraph num="H."> <text>A clean head towel or drape sheet shall be used for each patient.</text> </paragraph> <paragraph num="I."> <text>Each office shall contain and use sterilization equipment according to COMAR 10.53.09.</text> </paragraph> <paragraph num="J."> <text>Fresh disposable paper drapes shall be used on the treatment table or chair for each patient. Paper drapes shall be stored in a closed cabinet. Soiled disposable items shall be discarded into a container lined with a plastic bag, securely fastened, and removed daily.</text> </paragraph> <paragraph num="K."> <text>Each treatment room shall have a covered trash container.</text> </paragraph> <paragraph num="L."> <text>Smoking is prohibited in the treatment room.</text> </paragraph> <paragraph num="M."> <text>A clean lab coat or uniform is acceptable attire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Explanation to Patient of Electrology Practices."> <text>The electrologist shall explain the following to the patient before treatment:</text> <paragraph num="A."> <text>The treatment procedure, including standard precautions;</text> </paragraph> <paragraph num="B."> <text>The modality used;</text> </paragraph> <paragraph num="C."> <text>Hair growth cycles;</text> </paragraph> <paragraph num="D."> <text>Regrowth;</text> </paragraph> <paragraph num="E."> <text>The importance of keeping the follow-up treatment schedule;</text> </paragraph> <paragraph num="F."> <text>Possible tissue reactions following treatment;</text> </paragraph> <paragraph num="G."> <text>The importance of after-treatment care; and</text> </paragraph> <paragraph num="H."> <text>The treatment fee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Health Assessment."> <paragraph num="A."> <text>A complete past and current health history shall be obtained from each patient before treatment.</text> </paragraph> <paragraph num="B."> <text>The assessment shall be updated and evaluated on a current basis, and shall include the following:</text> <paragraph num="(1)"> <text>Name, address, telephone number, and date of birth;</text> </paragraph> <paragraph num="(2)"> <text>Medical history and current update;</text> </paragraph> <paragraph num="(3)"> <text>Prior methods of controlling or removing hair;</text> </paragraph> <paragraph num="(4)"> <text>Condition of tissue before initial treatment and any subsequent change;</text> </paragraph> <paragraph num="(5)"> <text>Pattern and structure of hair growth initially presented and significant subsequent changes;</text> </paragraph> <paragraph num="(6)"> <text>Date of each treatment;</text> </paragraph> <paragraph num="(7)"> <text>Area of treatment;</text> </paragraph> <paragraph num="(8)"> <text>Duration of treatment; and</text> </paragraph> <paragraph num="(9)"> <text>Fee charged.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Hand Washing and Use of Gloves."> <paragraph num="A."> <text>Electrologists shall wash their hands using soap, warm water, and good mechanical action immediately before and after treating each patient.</text> </paragraph> <paragraph num="B."> <text>A fresh pair of nonsterile, disposable examination gloves shall be worn during the treatment of each patient and while cleaning instruments.</text> </paragraph> <paragraph num="C."> <text>Electrologists shall wash their hands before putting on gloves and immediately after removing gloves.</text> </paragraph> <paragraph num="D."> <text>The electrologist shall follow universal/standard precautions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Sterility."> <paragraph num="A."> <text>A sterile needle and sterile tweezer shall be used for each patient.</text> </paragraph> <paragraph num="B."> <text>A sterile instrument or sterile tweezer shall be used for each patient to release ingrown hairs.</text> </paragraph> <paragraph num="C."> <text>Treatment solutions shall be:</text> <paragraph num="(1)"> <text>Labeled as to contents; and</text> </paragraph> <paragraph num="(2)"> <text>Covered when not in use.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Treatment."> <paragraph num="A."> <text>Skin area to be treated shall first be cleansed thoroughly with 70 percent isopropyl alcohol.</text> </paragraph> <paragraph num="B."> <text>An electrologist may not treat any mucous membrane or the external auditory canal of the ear without written approval of a licensed physician.</text> </paragraph> <paragraph num="C."> <text>An electrologist may not treat an infected area or skin malignancy.</text> </paragraph> <paragraph num="D."> <text>Applications To Be Used After Treatment.</text> <paragraph num="(1)"> <text>One of the following applications shall be applied to the tissue after treatment:</text> <paragraph num="(a)"> <text>70 percent isopropyl alcohol;</text> </paragraph> <paragraph num="(b)"> <text>Witch hazel;</text> </paragraph> <paragraph num="(c)"> <text>Hydrogen peroxide; or</text> </paragraph> <paragraph num="(d)"> <text>Other approved antiseptic for the skin.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ice, healing cream, or healing lotion may be used at the electrologist's discretion.</text> </paragraph> <paragraph num="(3)"> <text>Specific home care instructions shall be given to each patient after treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Disinfection and Environmental Controls."> <paragraph num="A."> <text>Disposable or damaged instruments shall be placed in a container which is impervious to puncture. The instruments shall be disinfected with a freshly prepared solution of household bleach and water consisting of 1 part bleach and 9 parts water, and allowed to stand for at least 30 minutes. The solution shall then be poured off, and the container securely sealed and disposed of in compliance with State, federal, and local laws.</text> </paragraph> <paragraph num="B."> <text>Removable tips of epilator probe holders shall be removed after each treatment and cleaned with soap or detergent and water, rinsed, dried, and disinfected by submersion in 70 percent isopropyl alcohol for at least 10 minutes. The covered container used to hold alcohol shall be emptied at least daily or sooner if visibly contaminated, then cleaned, dried, and refilled with fresh alcohol.</text> </paragraph> <paragraph num="C."> <text>Nonremovable tips of epilator probe holders shall be wiped with a detergent-germicide after each treatment.</text> </paragraph> <paragraph num="D."> <text>Epilator probe cords that have been in direct contact with a patient or practitioner shall be wiped with a detergent-germicide after each treatment.</text> </paragraph> <paragraph num="E."> <text>The treatment lamp shall be wiped with a detergent-germicide after each treatment.</text> </paragraph> <paragraph num="F."> <text>After each use, patient eyeshields shall be cleaned with soap or detergent and water, then rinsed and dried.</text> </paragraph> <paragraph num="G."> <text>A hospital grade disinfectant-detergent registered by the Environmental Protection Agency (EPA) shall be used for cleaning environmental surfaces.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 45)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective February 3, 1992 (19:2 Md. R. 154)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective February 19, 1993 (20:5 Md. R. 511); amended permanently effective May 10, 1993 (20:9 Md. R. 779)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Fees, repealed and new Regulations .01—.07 adopted under new chapter, Instruments and Procedures, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="09" heading="Sterilization Procedures"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Critical Items.</text> <paragraph num="(a)"> <text>“Critical items” means the instruments or objects that come in direct contact with the bloodstream or other normally sterile areas of the body.</text> </paragraph> <paragraph num="(b)"> <text>“Critical items” includes tweezers and needles.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Transfer forceps” means a medical tool that is used for grasping or holding things.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Generally."> <paragraph num="A."> <text>Each electrologist office and institution teaching the clinical practice of electrology shall maintain and use sterilization equipment adequate in size to accommodate critical items, transfer forceps, and soaking receptacles.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C of this regulation, critical items, transfer forceps, and soaking receptacles that are dropped on the floor or otherwise contaminated may not be used until sterilized.</text> </paragraph> <paragraph num="C."> <text>All needles used in an electrologist office and institution teaching the clinical practice of electrology shall be purchased as pre-sterilized and disposable for one-time use only. The sterilization procedure outlined in Regulation .04 of this chapter is not applicable to needles. If a needle is dropped on the floor or otherwise contaminated, the needle shall be properly disposed of and may not be used.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Cleansing Procedures."> <text>Prior to sterilization as required in Regulation .03 of this chapter, tweezers and needle caps shall be:</text> <paragraph num="A."> <text>Mechanically precleaned as follows:</text> <paragraph num="(1)"> <text>Cleansed with a clean cotton ball or swab moistened with a low-residue detergent and cool water;</text> </paragraph> <paragraph num="(2)"> <text>Accumulated in a holding container by submersion in a low-residue detergent and cool water; and</text> </paragraph> <paragraph num="(3)"> <text>Then, thoroughly rinsed with warm water and drained;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Then, cleaned by soaking in a protein-dissolving detergent enzyme cleaner or in an ultrasound cleaning unit according to manufacturer's instructions; and</text> </paragraph> <paragraph num="C."> <text>Rinsed and dried.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sterilization."> <paragraph num="A."> <text>Except as provided in Regulation .02C of this chapter, critical items, transfer forceps, and soaking receptacles shall be placed on a steel tray or rack in the center of an autoclave or heat sterilizer, separating instruments and keeping them away from the walls of the unit, and shall be sterilized according to manufacturer specifications or by:</text> <paragraph num="(1)"> <text>Autoclave at the temperatures listed for the following minimum time periods after completing a heat-up period:</text> <paragraph num="(a)"> <text>15—20 minutes at 121°C (250°F), 15 psi (pounds per square inch) for unpackaged instruments; and</text> </paragraph> <paragraph num="(b)"> <text>30 minutes at 121°C (250°F), 15 psi (pounds per square inch) for packaged instruments; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Dry heat, at the temperatures listed for the following minimum time periods after completing a heat-up period:</text> <paragraph num="(a)"> <text>170°C (340°F) for 1 hour; and</text> </paragraph> <paragraph num="(b)"> <text>160°C (320°F) for 2 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Sterile critical items, transfer forceps, and soaking receptacles shall be stored in sterile covered containers until used.</text> </paragraph> <paragraph num="C."> <text>Transfer forceps and holding containers shall be cleaned and sterilized daily or more frequently if visibly contaminated.</text> </paragraph> <paragraph num="D."> <text>Unused instruments in containers and containers that have been opened shall be resterilized after a 24-hour period.</text> </paragraph> <paragraph num="E."> <text>Dry heat ovens and autoclaves shall be of a type registered with the federal Food and Drug Administration (FDA) and shall be cleaned, used, and maintained according to manufacturers' instructions.</text> </paragraph> <paragraph num="F."> <text>Sterilizers shall have visible temperature and time indicators.</text> </paragraph> <paragraph num="G."> <text>Chemical indicators using color change materials shall be used on or in each package to assure that each package or container has been processed through the sterilization cycle.</text> </paragraph> <paragraph num="H."> <text>Biological indicators shall be used no less than once a month according to manufacturers’ instructions to assure that the sterilizer is functioning properly.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 45)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 5, 1991 (18:15 Md. R. 1727)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Requirements for Instructor's License, repealed and new Regulations .01—.03 adopted under new chapter, Sterilization Procedures, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation.04A amended effective September 15, 2025 (52:18 Md. R. 923)</annotation> </annotations> </chapter> <chapter num="10" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Advertising Standards."> <paragraph num="A."> <text>An electrologist shall include one of the following qualifications in an advertisement:</text> <paragraph num="(1)"> <text>Licensed electrologist;</text> </paragraph> <paragraph num="(2)"> <text>Licensed electrology instructor; or</text> </paragraph> <paragraph num="(3)"> <text>Licensed by the Board of Nursing — Electrology Practice Committee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An electrologist shall include in any advertising the name and address of at least one licensed electrologist or licensed electrology instructor practicing at the location advertised.</text> </paragraph> <paragraph num="C."> <text>An electrologist may not, on behalf of the electrologist, a partner, an associate, or electrology affiliate, use or participate in the use of any form of public communication which contains a deceptive or misleading statement or claim. A deceptive or misleading statement or claim is one that:</text> <paragraph num="(1)"> <text>States or implies:</text> <paragraph num="(a)"> <text>That the electrologist is a certified or recognized specialist other than as licensed by the Board, unless the statement is true;</text> </paragraph> <paragraph num="(b)"> <text>That the electrologist has superior education or credentials that are different than any other licensed electrologist or licensed electrologist instructor, if they are not;</text> </paragraph> <paragraph num="(c)"> <text>An unwarranted claim of superior service;</text> </paragraph> <paragraph num="(d)"> <text>A material misrepresentation of fact or presentation of fact that is likely to cause an ordinary prudent individual to misunderstand or to be deceived; or</text> </paragraph> <paragraph num="(e)"> <text>An unreasonable claim likely to create unjustified expectations; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Fails to include any fact necessary to make a statement not misleading.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An electrologist may not use electronic media, including telephone, radio, internet, and motion pictures, in a manner that is unreasonable, misleading, or fraudulent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Licenses."> <text>Electrologists or electrology instructors advertising other services for which they are licensed within one advertisement shall:</text> <paragraph num="A."> <text>List each license held; and</text> </paragraph> <paragraph num="B."> <text>Clearly state each service offered under each license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Fees."> <text>A statement regarding fees shall be considered deceptive or misleading if the electrologist:</text> <paragraph num="A."> <text>Charges more than the fee advertised for a service rendered; or</text> </paragraph> <paragraph num="B."> <text>Fails to offer the service at the fee advertised for a reasonable period of time after the advertisement unless a specific time limit is included in the original advertisement.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Responsibility."> <text>An electrologist shall be responsible for an advertisement of service regardless of whether the advertising has been generated by the electrologist personally, by an employee, or by a proprietorship, partnership, corporation, union, clinic or institution, which uses the electrologist's services.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties."> <text>Violation of this chapter is a violation of Health Occupations Article, §§8-6B-23 and 8-6B-18(a)(10), Annotated Code of Maryland, and may result in disciplinary action pursuant to Health Occupations Article, §8-6B-18, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205 and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 45)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C, D amended effective July 20, 1992 (19:14 Md. R. 1284)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01, Requirements for Institutions Teaching the Theory or Clinical Practice of Electrology, repealed and new Regulations .01—.05 adopted under new chapter, Advertising, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> </annotations> </chapter> <chapter num="11" heading="Rehabilitation Committee" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: January 16, 1984 (11:1 Md. R. 45)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 16, 2000 (27:20 Md. R. 1839)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08, Procedure for Board Hearings, repealed and new Regulation .01 adopted under new chapter, Rehabilitation Committee, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 7, 2007 (34:9 Md. R. 825)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective July 2, 2018 (45:13 Md. R. 667)</annotation> </annotations> </chapter> <chapter num="12" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Fees."> <paragraph num="A."> <text>Fees are not refundable.</text> </paragraph> <paragraph num="B."> <text>The following fees are established by the Board:</text> <paragraph num="(1)"> <text>Application fee — $100;</text> </paragraph> <paragraph num="(2)"> <text>Initial Clinical examination — $100 (An initial exam applicant shall submit to the Board the application fee, initial clinical examination, and completed application.);</text> </paragraph> <paragraph num="(3)"> <text>Clinical reexamination — $100;</text> </paragraph> <paragraph num="(4)"> <text>Biennial renewal — $200;</text> </paragraph> <paragraph num="(5)"> <text>Inactive status (one-time fee) — $25 (no fee required if placed on inactive status by the Board for failure to submit required CEUs);</text> </paragraph> <paragraph num="(6)"> <text>Returned check — $25; and</text> </paragraph> <paragraph num="(7)"> <text>Verification of Maryland licensure to another state or jurisdiction — $25.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Fees for the theory examination shall be $100 or less as set by the Board-approved testing service.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-01—8-6B-29, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 30, 1991 (18:19 Md. R. 2102)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 20, 1994 (21:12 Md. R. 1061)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 20, 1994 (21:12 Md. R. 1061)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, Continuing Education, repealed and new Regulation .01 adopted under new chapter, Fees, effective June 20, 2005 (32:12 Md. R. 1047)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective August 18, 2011 (38:19 Md. R. 1146); amended permanently effective October 17, 2011 (38:21 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective August 19, 2013 (40:16 Md. R. 1344); May 20, 2019 (46:10 Md. R. 490)</annotation> </annotations> </chapter> <chapter num="13" heading="Examination for Special Needs Applicants" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 26, 1993 (20:8 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective June 20, 2005 (32:12 Md. R. 1047)</annotation> </annotations> </chapter> <chapter num="14" heading="Monetary Penalties" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1996 (22:26 Md. R. 2030)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective June 20, 2005 (32:12 Md. R. 1047)</annotation> </annotations> </chapter> </subtitle> <subtitle num="54" heading="Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)"> <chapter num="01" heading="Eligibility, Participation, and Benefits"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter specifies the eligibility policies and procedures and the benefits available under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program or Program) operated by the Maryland Department of Health, with funding substantially provided by the United States Department of Agriculture (USDA) under the Child Nutrition Act of 1966, §17, as amended.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose."> <paragraph num="A."> <text>The WIC Program provides supplemental foods and nutrition education, including breastfeeding promotion and support:</text> <paragraph num="(1)"> <text>Through local agencies at no cost to eligible individuals; and</text> </paragraph> <paragraph num="(2)"> <text>To pregnant women, postpartum women, breastfeeding women, infants, and children, who are from families with income below a certain established amount and who are determined by a competent professional authority or a competent paraprofessional authority to be at risk with respect to their physical and mental health by reason of inadequate nutrition or health care, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The WIC Program serves as an adjunct to good health care during critical times of growth and development in order to prevent health problems and improve the health status of participants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incorporations by Reference."> <text>In this chapter, the following are incorporated by reference:</text> <paragraph num="A."> <text>42 U.S.C. §1786, as amended;</text> </paragraph> <paragraph num="B."> <text>7 CFR 246, as amended; and</text> </paragraph> <paragraph num="C."> <text>7 CFR 15, 15a, and 15b, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means an individual who has requested or on whose behalf another person has requested WIC benefits in person, either orally or in writing, under the provisions of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Benefits” means the foods prescribed and services provided to a participant by the Program.</text> </paragraph> <paragraph num="(3)"> <text>“Breastfeeding woman” means a woman up to 1 year postpartum who is breastfeeding her infant.</text> </paragraph> <paragraph num="(4)"> <text>“Caretaker” means an individual who is responsible for the care and welfare of a participant.</text> </paragraph> <paragraph num="(5)"> <text>“Caseload” means the participation level that is assigned to a local agency by the State agency.</text> </paragraph> <paragraph num="(6)"> <text>“Certification” means the implementation of criteria and procedures to assess and document an applicant's eligibility for the Program.</text> </paragraph> <paragraph num="(7)"> <text>“Certification period” means the time period for which a participant has been authorized by a local agency as eligible for Program benefits.</text> </paragraph> <paragraph num="(8)"> <text>“Child” means an individual who is 1 year old or older but is younger than 5 years old.</text> </paragraph> <paragraph num="(9)"> <text>“Clinic” means a local agency facility where an applicant is certified.</text> </paragraph> <paragraph num="(10)"> <text>“Competent paraprofessional authority” means an individual who:</text> <paragraph num="(a)"> <text>Does not meet the definition of a competent professional authority;</text> </paragraph> <paragraph num="(b)"> <text>Successfully completes a WIC training program approved by the State agency; and</text> </paragraph> <paragraph num="(c)"> <text>Performs certifications under the supervision of a competent professional authority.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Competent Professional Authority.</text> <paragraph num="(a)"> <text>“Competent professional authority” means an individual who is a:</text> <paragraph num="(i)"> <text>Physician;</text> </paragraph> <paragraph num="(ii)"> <text>Nutritionist;</text> </paragraph> <paragraph num="(iii)"> <text>Dietitian;</text> </paragraph> <paragraph num="(iv)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(v)"> <text>Physician's assistant certified by the National Committee on Certification of Physician's Assistants or certified by the State Board of Physician Quality Assurance; or</text> </paragraph> <paragraph num="(vi)"> <text>State or local medically trained health official.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Competent professional authority” includes an individual who is:</text> <paragraph num="(i)"> <text>On the staff of the local agency and authorized by the State agency to serve as a competent professional authority; or</text> </paragraph> <paragraph num="(ii)"> <text>Not on the staff of the local agency, but who is qualified to provide data upon which a nutritional risk determination is made by a competent professional authority on the staff of the local agency.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Complementary feeding process” means a nutrition risk that applies to an infant or a child from 4 through 23 months old who has begun to or is expected to begin to:</text> <paragraph num="(a)"> <text>Consume foods or beverages complementary to breast feeding;</text> </paragraph> <paragraph num="(b)"> <text>Eat independently;</text> </paragraph> <paragraph num="(c)"> <text>Be weaned from breast milk or infant formula; or</text> </paragraph> <paragraph num="(d)"> <text>Transition from a diet specifically intended for infants or toddlers to one based on the Dietary Guidelines for Americans, as updated every 5 years by the United States Department of Agriculture with the United States Department of Health and Human Services under Title III of Public Law 101-445 of the National Nutrition Monitoring and Related Research Act of 1990.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Day” means a calendar day.</text> </paragraph> <paragraph num="(14)"> <text>“Disqualification” means the act of ending the Program participation of a participant, whether as a punitive sanction or for administrative reasons.</text> </paragraph> <paragraph num="(15)"> <text>“Dual participation” means an individual's simultaneous participation in the WIC Program in more than one state, local agency, or clinic, or participation in the WIC Program and in the Commodity Supplemental Food Program funded by the USDA during the same period of time.</text> </paragraph> <paragraph num="(16)"> <text>“Family” means a group of related or nonrelated individuals who are not residents of an institution but who are living together as one economic unit, except that residents of a homeless facility or an institution may not all be considered as members of a single family.</text> </paragraph> <paragraph num="(17)"> <text>“Food delivery system” means the method used by a local agency to provide supplemental foods to a participant.</text> </paragraph> <paragraph num="(18)"> <text>“Food instrument” means an electronic benefits transfer (EBT) card or other document that is used by a participant to obtain supplemental foods.</text> </paragraph> <paragraph num="(19)"> <text>“Health services” means ongoing, routine, pediatric, and obstetric care or referral for treatment.</text> </paragraph> <paragraph num="(20)"> <text>“HHS” means the United States Department of Health and Human Services.</text> </paragraph> <paragraph num="(21)"> <text>Income.</text> <paragraph num="(a)"> <text>“Income” means gross cash income before deductions for:</text> <paragraph num="(i)"> <text>Income taxes;</text> </paragraph> <paragraph num="(ii)"> <text>An employee's Social Security taxes;</text> </paragraph> <paragraph num="(iii)"> <text>Insurance premiums;</text> </paragraph> <paragraph num="(iv)"> <text>Bonds;</text> </paragraph> <paragraph num="(v)"> <text>Housing subsidy in the form of cash or stipend; or</text> </paragraph> <paragraph num="(vi)"> <text>Cash food subsidy.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Income” includes:</text> <paragraph num="(i)"> <text>Monetary compensation for services, including wages, salary, commissions, or fees;</text> </paragraph> <paragraph num="(ii)"> <text>Net income from farm and nonfarm self-employment;</text> </paragraph> <paragraph num="(iii)"> <text>Social Security benefits;</text> </paragraph> <paragraph num="(iv)"> <text>Dividends or interest on savings or bonds, income from estates or trusts, or net rental income;</text> </paragraph> <paragraph num="(v)"> <text>Public assistance or welfare payments;</text> </paragraph> <paragraph num="(vi)"> <text>Unemployment compensation;</text> </paragraph> <paragraph num="(vii)"> <text>Government civilian employee or military retirement pensions, or veterans' payments;</text> </paragraph> <paragraph num="(viii)"> <text>Private pensions or annuities;</text> </paragraph> <paragraph num="(ix)"> <text>Alimony or child support payments;</text> </paragraph> <paragraph num="(x)"> <text>Regular contributions from individuals not living in the household;</text> </paragraph> <paragraph num="(xi)"> <text>Net royalties;</text> </paragraph> <paragraph num="(xii)"> <text>Other cash income, which includes, but is not limited to, cash amounts received or withdrawn from any source including savings, investments, trust accounts, and other resources that are readily available to the applicant or the applicant's family; or</text> </paragraph> <paragraph num="(xiii)"> <text>Cash contributions from others residing in the same living quarters as the applicant.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Income” does not include payments or benefits excluded under 7 CFR §246.7(d)(2)(iv).</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Infant” means an individual younger than 1 year old.</text> </paragraph> <paragraph num="(23)"> <text>“Instream migrant” means a migrant farm worker or an individual accompanying a migrant farm worker who is traveling and currently employed or seeking employment in seasonal agricultural work that causes the migrant to move from the migrant's home.</text> </paragraph> <paragraph num="(24)"> <text>“Local agency” means a public or private, nonprofit health or human service agency that provides health services, either directly or through contract.</text> </paragraph> <paragraph num="(25)"> <text>“Migrant farm worker” means an individual:</text> <paragraph num="(a)"> <text>Whose principal employment is in agriculture on a seasonal basis;</text> </paragraph> <paragraph num="(b)"> <text>Who has been employed in agriculture on a seasonal basis within the last 24 months; and</text> </paragraph> <paragraph num="(c)"> <text>Who establishes, for the purpose of employment in agriculture on a seasonal basis, a temporary home.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Nutritional risk” means:</text> <paragraph num="(a)"> <text>Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements;</text> </paragraph> <paragraph num="(b)"> <text>Other documented nutritionally related medical conditions;</text> </paragraph> <paragraph num="(c)"> <text>Dietary deficiencies that impair or endanger health;</text> </paragraph> <paragraph num="(d)"> <text>Conditions that directly affect the nutritional health of an individual, including alcoholism or drug abuse; or</text> </paragraph> <paragraph num="(e)"> <text>Conditions that predispose individuals to inadequate nutritional patterns or nutritionally related medical conditions, including but not limited to homelessness and migrancy.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Nutrition education” means individual or group education sessions and the provision of information and educational materials designed to improve health status, achieve positive change in dietary and physical activity habits, and emphasize relationships between nutrition, physical activity, and health, all in keeping with the individual's personal and cultural preferences.</text> </paragraph> <paragraph num="(28)"> <text>“Nutritionist” means an individual licensed in Maryland who has a bachelor's or master's degree in nutritional sciences, community nutrition, clinical nutrition, dietetics, public health nutrition, or home economics with an emphasis in nutrition.</text> </paragraph> <paragraph num="(29)"> <text>“Participant” means a pregnant woman, breastfeeding woman, postpartum woman, infant, or child who is receiving benefits under the Program, and the breastfed infant of a breastfeeding woman participant.</text> </paragraph> <paragraph num="(30)"> <text>“Participation” means receiving benefits under the Program.</text> </paragraph> <paragraph num="(31)"> <text>“Participation data” means information concerning the number of:</text> <paragraph num="(a)"> <text>Individuals who received benefits during a reporting period;</text> </paragraph> <paragraph num="(b)"> <text>Infants who received no benefits during a reporting period, but who were breastfed by participant breastfeeding women; and</text> </paragraph> <paragraph num="(c)"> <text>Breastfeeding women who did not receive benefits but whose infant received benefits during the reporting period.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Postpartum woman” means a woman up to 6 months after the termination of her pregnancy.</text> </paragraph> <paragraph num="(33)"> <text>“Poverty income guidelines” means the poverty income guidelines prescribed and adjusted annually by HHS.</text> </paragraph> <paragraph num="(34)"> <text>“Pregnant woman” means a woman who is determined to have one or more embryos or fetuses in utero.</text> </paragraph> <paragraph num="(35)"> <text>“Program” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended.</text> </paragraph> <paragraph num="(36)"> <text>“Proxy” means an individual who is designated by a participant or a child or infant participant’s parent, guardian, or caretaker to receive food instruments and to redeem food benefits for the participant and whose name is on file at the local agency.</text> </paragraph> <paragraph num="(37)"> <text>“Special nutritional risk applicant” means a migrant farmworker or a migrant farmworker's family, a pregnant woman, or an infant.</text> </paragraph> <paragraph num="(38)"> <text>“State agency” means the Maryland Department of Health's WIC Program.</text> </paragraph> <paragraph num="(39)"> <text>“Supplemental foods" means those foods containing nutrients determined to be beneficial for a pregnant woman, breastfeeding woman, postpartum woman, infant, or child, as prescribed by the Secretary of the USDA under 7 CFR §246.10, which is incorporated by reference in Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(40)"> <text>“USDA” means the United States Department of Agriculture.</text> </paragraph> <paragraph num="(41)"> <text>“Verification of certification” means a document that provides proof of Program eligibility for the participant who is transferring from one WIC agency to another.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Eligibility Criteria."> <paragraph num="A."> <text>An applicant shall be certified as eligible before participating in the Program.</text> </paragraph> <paragraph num="B."> <text>To be certified as eligible for the Program, an infant, a child, or a pregnant, postpartum, or breastfeeding woman:</text> <paragraph num="(1)"> <text>Shall reside, without regard to the length of residency, within the jurisdiction of:</text> <paragraph num="(a)"> <text>Maryland, unless a reciprocal agreement has been established with another State agency; and</text> </paragraph> <paragraph num="(b)"> <text>The local agency as defined by the State agency;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall present documentation of identity for the application for benefits;</text> </paragraph> <paragraph num="(3)"> <text>Shall be determined by the local agency to be income eligible pursuant to the specifications set forth in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Shall be at nutritional risk pursuant to the specifications set forth in Regulation .08 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>May not engage in dual participation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Residency Eligibility Determination Process."> <paragraph num="A."> <text>In order to be eligible for WIC benefits, an applicant shall provide to a local agency documentation of Maryland residency, or residency in a state having a reciprocal residency agreement with Maryland.</text> </paragraph> <paragraph num="B."> <text>Documentation. In order to document residency, an applicant shall provide to the local agency one of the following:</text> <paragraph num="(1)"> <text>Dated correspondence documenting the applicant’s home address;</text> </paragraph> <paragraph num="(2)"> <text>Maryland driver's license or identification card;</text> </paragraph> <paragraph num="(3)"> <text>In the case of an applicant who was a prior participant, documentation that the applicant still resides at the same address that is on file with the WIC Program; or</text> </paragraph> <paragraph num="(4)"> <text>Another item that confirms the residency of the applicant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Recording of Residency Documentation. A local agency shall document proof of residency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Income Eligibility Determination Process."> <paragraph num="A."> <text>Determining Income.</text> <paragraph num="(1)"> <text>In order to determine whether an applicant is income-eligible for Program participation, a local agency shall determine the applicant's income, which is determined pursuant to family size as set forth in §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Subject to the provisions of this regulation, a local agency shall determine an applicant’s income by adding together the sources of income for an applicant and the applicant’s family.</text> </paragraph> <paragraph num="(3)"> <text>In determining an applicant’s family income, a local agency shall consider the family’s income to be the more accurate figure between the family’s income for the previous 12 months or the family’s current rate of income for the last 30 days.</text> </paragraph> <paragraph num="(4)"> <text>If an applicant meets the income eligibility guidelines, a local agency shall declare the applicant income-eligible for WIC benefits based on the applicant's family income.</text> </paragraph> <paragraph num="(5)"> <text>An applicant shall provide to the local agency documentation of the applicant's family income, as set forth in §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to determine whether an applicant is income-eligible for Program participation, a local agency shall determine the size of the applicant's family according to the following:</text> <paragraph num="(1)"> <text>In the case of a pregnant woman, the unborn child or children are counted only if this action allows the woman to meet income eligibility standards;</text> </paragraph> <paragraph num="(2)"> <text>An infant or child is counted in the family size of the parent, caretaker, or guardian with whom the infant or child resides;</text> </paragraph> <paragraph num="(3)"> <text>An infant, child, or other family member residing in a school or institution is counted in the family size of the parent, caretaker, or guardian who is providing economic support for that infant, child, or family member;</text> </paragraph> <paragraph num="(4)"> <text>An infant or child who is a foster child living with a family, but who remains the legal responsibility of a welfare or other agency, is counted as a family of one and payments made by the agency or other sources to the family for the care of that foster child are the income of that foster child; and</text> </paragraph> <paragraph num="(5)"> <text>An adopted child or individual for whom a family member has accepted legal responsibility is counted in the family size for that family with whom the individual resides.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Recording of Income Information.</text> <paragraph num="(1)"> <text>A local agency shall document proof of income.</text> </paragraph> <paragraph num="(2)"> <text>If an applicant claims to have no income, the applicant shall complete the form provided by the State agency declaring zero income.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Determining Income Eligibility.</text> <paragraph num="(1)"> <text>After a local agency has recorded the family size information of an applicant, the local agency shall determine whether the applicant is income-eligible for Program participation.</text> </paragraph> <paragraph num="(2)"> <text>To be considered eligible for the Program, an applicant and the applicant’s family shall have a gross income that is less than or equal to 185 percent of the poverty income guidelines issued by HHS, or shall provide documentation that the applicant is a recipient of:</text> <paragraph num="(a)"> <text>Food stamps under the Food Stamp Act of 1977;</text> </paragraph> <paragraph num="(b)"> <text>Benefits under Maryland's Temporary Cash Assistance program established under Part A of Title IV of the Social Security Act;</text> </paragraph> <paragraph num="(c)"> <text>Medical Assistance Program under Title XIX of the Social Security Act; or</text> </paragraph> <paragraph num="(d)"> <text>Another State-administered program that routinely requires documentation of income, if the program has income eligibility guidelines at or below the WIC Program's income guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A local agency shall determine an applicant to be automatically income-eligible for the WIC Program if a member of the applicant’s family is:</text> <paragraph num="(a)"> <text>Receiving benefits under Maryland's Temporary Cash Assistance program; or</text> </paragraph> <paragraph num="(b)"> <text>A pregnant woman or an infant currently participating in the Medical Assistance Program under Title XIX of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A local agency shall use the current poverty income guidelines issued by HHS and transmitted by the State agency in determining applicant eligibility.</text> </paragraph> <paragraph num="(5)"> <text>The State agency shall adjust the Program income eligibility guidelines annually at the time the State implements income eligibility guidelines under the Medical Assistance Program.</text> </paragraph> <paragraph num="(6)"> <text>Instream Migrant Farm Worker. A local agency shall consider that:</text> <paragraph num="(a)"> <text>An instream migrant farm worker applicant or the family of an instream migrant farm worker applicant with an expired verification of certification is income-eligible for Program certification if the instream migrant farm worker’s family income was determined at least once within the past 12 months; and</text> </paragraph> <paragraph num="(b)"> <text>A member of an instream migrant farm worker family is income-eligible for Program certification if the income criteria was met either in the migrant's home state before the migrant entered the stream for a particular agricultural season or in an instream area during the agricultural season.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation of Income.</text> <paragraph num="(1)"> <text>An applicant shall provide to the local agency documentation of the applicant's family income.</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §E(3) of this regulation, a local agency shall accept any of the following as documentation of income:</text> <paragraph num="(a)"> <text>Pay stubs;</text> </paragraph> <paragraph num="(b)"> <text>Income tax returns;</text> </paragraph> <paragraph num="(c)"> <text>W-2 forms;</text> </paragraph> <paragraph num="(d)"> <text>Forms showing eligibility or benefit levels; and</text> </paragraph> <paragraph num="(e)"> <text>Documents confirming participation in another State-administered program whose income eligibility guidelines are less than or equal to the WIC Program's income eligibility guidelines.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an applicant cannot provide a document cited in §E(2) of this regulation, a local agency may confirm the applicant's participation in another State-administered program by telephoning the appropriate staff person of that program and documenting the telephone contact in the applicant's record.</text> </paragraph> <paragraph num="(4)"> <text>A local agency shall deny Program participation to an applicant who fails to provide income documentation within 30 days of the date that the individual applied for Program benefits.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Nutritional Risk Determination Process."> <paragraph num="A."> <text>After an applicant is found to meet the Program’s income eligibility standards as specified in Regulation .07 of this chapter, in order for the applicant to receive WIC benefits, the applicant shall be found by the Program to be at nutritional risk.</text> </paragraph> <paragraph num="B."> <text>In order to determine whether an applicant is at nutritional risk, a competent professional authority or a competent paraprofessional authority on the staff of the local agency shall perform a nutritional assessment based on either information gathered by the local agency or information provided by a competent professional authority not on the staff of the local agency.</text> </paragraph> <paragraph num="C."> <text>A local agency may not compel an applicant to:</text> <paragraph num="(1)"> <text>Have the nutritional risk assessment completed by a specific medical provider; or</text> </paragraph> <paragraph num="(2)"> <text>Receive ongoing medical care under the local agency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In conducting a nutritional risk assessment, a local agency, competent professional authority, or competent paraprofessional authority shall assess each applicant’s height (or length) and weight measurements at the time of certification by:</text> <paragraph num="(1)"> <text>Performing the measurements on each applicant;</text> </paragraph> <paragraph num="(2)"> <text>Requiring documentation of each applicant's measurements from a health care provider; or</text> </paragraph> <paragraph num="(3)"> <text>In its discretion, both §D(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Hematological Tests.</text> <paragraph num="(1)"> <text>In addition to the assessments set forth in §D of this regulation, a local agency, competent professional authority, or competent paraprofessional authority shall:</text> <paragraph num="(a)"> <text>Perform a hematological test for anemia such as a hemoglobin or hematocrit;</text> </paragraph> <paragraph num="(b)"> <text>Require documentation of the test from a health care provider at the time of certification for applicants with no other nutritional risk factor present; or</text> </paragraph> <paragraph num="(c)"> <text>In its discretion, both §E(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For applicants with a qualifying nutritional risk factor present at certification, a local agency, competent professional authority, or competent paraprofessional authority shall within 90 days of the certification:</text> <paragraph num="(a)"> <text>Perform a hematological test;</text> </paragraph> <paragraph num="(b)"> <text>Require documentation of the test from a health care provider; or</text> </paragraph> <paragraph num="(c)"> <text>In its discretion, both §E(2)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The local agency, competent professional authority, or competent paraprofessional authority shall perform or require documentation of the hematological test as follows:</text> <paragraph num="(a)"> <text>For a pregnant woman, during pregnancy;</text> </paragraph> <paragraph num="(b)"> <text>For a breastfeeding or postpartum woman, after the termination of pregnancy;</text> </paragraph> <paragraph num="(c)"> <text>For a breastfeeding woman 6—12 months postpartum, if a test was not performed after the termination of pregnancy or whose test result after pregnancy was below normal range;</text> </paragraph> <paragraph num="(d)"> <text>For an infant, 9—12 months old;</text> </paragraph> <paragraph num="(e)"> <text>For a child 12—24 months old, any time during that period, but, if possible, at 6 months after the infant test;</text> </paragraph> <paragraph num="(f)"> <text>For a child 2 years old or older, whose test result at the child's last certification is within the normal range, at least once every 12 months; and</text> </paragraph> <paragraph num="(g)"> <text>For a child 2 years old or older whose test result at the child’s last certification is below normal range, at 6 month intervals until the result is within normal range.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The local agency, competent professional authority, or competent paraprofessional authority shall obtain a nutrition history for each applicant.</text> </paragraph> <paragraph num="G."> <text>Using the information gathered pursuant to §§D—F of this regulation, a competent professional authority or competent paraprofessional authority shall use the nutritional risk criteria found in Charts A and B in Regulation .11 of this chapter to determine if the applicant is at nutritional risk pursuant to the priority levels set forth in Regulation .09 of this chapter, and thus eligible for the Program.</text> </paragraph> <paragraph num="H."> <text>A local agency:</text> <paragraph num="(1)"> <text>May determine a breastfeeding woman to be at nutritional risk if her breastfed infant has been determined to be at nutritional risk;</text> </paragraph> <paragraph num="(2)"> <text>May certify a breastfed infant to be at nutritional risk if the infant's mother is determined to be at nutritional risk;</text> </paragraph> <paragraph num="(3)"> <text>Shall place a breastfeeding mother and her infant in the highest priority level for which either is qualified;</text> </paragraph> <paragraph num="(4)"> <text>Shall place an applicant exhibiting more than one risk factor in the highest applicable priority level; and</text> </paragraph> <paragraph num="(5)"> <text>May not place an individual in successive certification periods whose only identified risk factor is possibility of regression of nutritional status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Priority Levels of Nutritional Risk."> <paragraph num="A."> <text>A local agency shall classify applicants according to priority levels of nutritional risk.</text> </paragraph> <paragraph num="B."> <text>Priority Levels of Nutritional Risk.</text> <paragraph num="(1)"> <text>Priority I. Priority I is a pregnant woman, a breastfeeding woman, or an infant at nutritional risk because of:</text> <paragraph num="(a)"> <text>Detrimental or abnormal nutritional conditions detected by biochemical or anthropometric measurements;</text> </paragraph> <paragraph num="(b)"> <text>Other documented nutritionally related medical conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Conditions that directly affect the nutritional health of an individual, including depression, smoking, alcoholism, or drug abuse.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Priority II. Except for an infant who qualifies for Priority I, Priority II is:</text> <paragraph num="(a)"> <text>An infant younger than 6 months old born to a woman who was a Program participant during her pregnancy;</text> </paragraph> <paragraph num="(b)"> <text>An infant younger than 6 months old born to a woman who was not a Program participant during pregnancy but whose medical records document that the woman was at nutritional risk during the pregnancy due to nutrition conditions detectable by biochemical or anthropometric measurements or other documented, nutritionally related medical conditions that demonstrated the individual’s need for supplemental foods; or</text> </paragraph> <paragraph num="(c)"> <text>A breastfeeding mother of a breastfed infant who has been certified in the Program as Priority II.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Priority III. Priority III is a child or postpartum woman at nutritional risk because of:</text> <paragraph num="(a)"> <text>Detrimental or abnormal nutritional conditions detected by biochemical or anthropometric measurements;</text> </paragraph> <paragraph num="(b)"> <text>Other documented nutritionally related medical conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Conditions that directly affect the nutritional health of an individual, including depression, smoking, alcoholism, or drug abuse.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Priority IV. Priority IV is a:</text> <paragraph num="(a)"> <text>Pregnant woman, a breastfeeding woman, or an infant at nutritional risk because of:</text> <paragraph num="(i)"> <text>Dietary deficiencies that impair or endanger health; or</text> </paragraph> <paragraph num="(ii)"> <text>Conditions that predispose the individual to inadequate nutritional patterns, including homelessness or migrancy; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Breastfeeding woman or an infant at nutritional risk because of possibility of regression of nutritional status.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Priority V. Priority V is a child at nutritional risk because of:</text> <paragraph num="(a)"> <text>Dietary deficiencies that impair or endanger health;</text> </paragraph> <paragraph num="(b)"> <text>Conditions that predispose the child to inadequate nutritional patterns, including homelessness or migrancy; or</text> </paragraph> <paragraph num="(c)"> <text>Possibility of regression of nutritional status.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Priority VI. Priority VI is a postpartum woman at nutritional risk because of:</text> <paragraph num="(a)"> <text>Dietary deficiencies that impair or endanger health;</text> </paragraph> <paragraph num="(b)"> <text>Conditions that predispose the individual to inadequate nutritional patterns, including homelessness or migrancy; or</text> </paragraph> <paragraph num="(c)"> <text>Possibility of regression of nutritional status.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Priority Waiting List."> <paragraph num="A."> <text>When it is serving its maximum caseload, a local agency shall maintain a priority waiting list of individuals seeking Program benefits.</text> </paragraph> <paragraph num="B."> <text>In order to be placed on the priority waiting list, an individual shall be certified as eligible to participate in the Program.</text> </paragraph> <paragraph num="C."> <text>A local agency shall place an individual on a priority waiting list according to the priority levels set forth in Regulation .09 of this chapter, as follows:</text> <paragraph num="(1)"> <text>To be placed on the priority waiting list in Priority levels I—V, an individual shall seek certification and be successfully certified by the local agency as eligible for Program benefits; and</text> </paragraph> <paragraph num="(2)"> <text>To be placed on the priority waiting list in Priority level VI, an individual may request to be on the waiting list over the telephone, unless the individual's postpartum status is at issue, in which case the local agency shall place the individual on the waiting list only after the individual receives a personal assessment at the local agency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The State agency may advise the local agency that one or more priority levels may be excluded from consideration for the waiting list if it is not possible for those priority levels to be placed on the Program in the foreseeable future. However, if an applicant meets the requirements for one of the priority levels and requests placement on a priority waiting list, the applicant may not be denied inclusion.</text> </paragraph> <paragraph num="E."> <text>An individual on the waiting list shall be selected for Program participation as soon as services become available. An individual in the highest priority level of the waiting list shall receive services before an individual in the next highest priority level on the waiting list receives services. Within a priority group, an applicant shall receive services on a first-come, first-served basis.</text> </paragraph> <paragraph num="F."> <text>A local agency shall notify an individual of placement on the waiting list within 20 days of the date that the individual applies for Program benefits, or in the case of an infant or pregnant woman, within 10 days of the date that the application for benefits was made.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Nutritional Risk Factors."> <paragraph num="A."> <text>For purposes of the WIC Program, to be considered at nutritional risk:</text> <paragraph num="(1)"> <text>A woman shall exhibit one or, where specified, two of the nutritional risk factors listed in Chart A, as shown in §B of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>An infant or child shall exhibit one or, where specified, two of the nutritional risk factors listed in Chart B, as shown in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Explanation of Charts.</text> </paragraph> <paragraph num="C."> <text>Chart A.</text> </paragraph> <paragraph num="D."> <text>Chart B.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Application Processing Procedures."> <paragraph num="A."> <text>A local agency shall perform the certification process at no cost to the applicant.</text> </paragraph> <paragraph num="B."> <text>To lend administrative efficiency and participant convenience to the certification process, a local agency shall, whenever possible, use intake procedures for processing applications that are combined with intake procedures for other health programs or services administered by the local agency. These procedures may include:</text> <paragraph num="(1)"> <text>Verification procedures;</text> </paragraph> <paragraph num="(2)"> <text>Certification interviews; and</text> </paragraph> <paragraph num="(3)"> <text>Income computations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When a local agency is not serving its maximum case load, the local agency shall:</text> <paragraph num="(1)"> <text>Accept an application;</text> </paragraph> <paragraph num="(2)"> <text>Arrive at an eligibility determination;</text> </paragraph> <paragraph num="(3)"> <text>Notify the applicant of the decision made; and</text> </paragraph> <paragraph num="(4)"> <text>Issue food instruments pursuant to the terms set forth in §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To ensure that accurate records are kept of the date of an application, the local agency shall, at the time of each visit record the:</text> <paragraph num="(1)"> <text>Applicant's name;</text> </paragraph> <paragraph num="(2)"> <text>Applicant's address; and</text> </paragraph> <paragraph num="(3)"> <text>Date of the visit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Time Frames.</text> <paragraph num="(1)"> <text>A local agency shall notify a special nutritional risk applicant of an eligibility or ineligibility determination within 10 days of the date of the application for Program benefits, except that the State agency may provide an extension of the notification period to a maximum of 15 days for the local agency that makes a written request which includes a justification of the need for an extension; or</text> </paragraph> <paragraph num="(2)"> <text>A local agency shall notify other applicants of their eligibility or ineligibility within 20 days of the date of the application for Program benefits.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If, during a certification visit, a local agency determines that an applicant is ineligible for the Program, the local agency shall:</text> <paragraph num="(1)"> <text>Inform the special nutritional risk applicant within 10 days of the certification visit, and other applicants within 20 days of the certification visit, of the:</text> <paragraph num="(a)"> <text>Applicant's ineligibility;</text> </paragraph> <paragraph num="(b)"> <text>Reason for ineligibility; and</text> </paragraph> <paragraph num="(c)"> <text>Applicant's right to a fair hearing on the ineligibility determination;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Document the reasons for ineligibility; and</text> </paragraph> <paragraph num="(3)"> <text>Retain this information on file at the local agency.</text> </paragraph> </paragraph> <paragraph num="G."> <text>At the same time an applicant completes the certification process and the local agency determines the applicant to be eligible for Program benefits, the local agency shall issue benefits for up to 90 days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Certification Periods."> <paragraph num="A."> <text>A local agency shall certify an applicant for Program benefits for the following time periods:</text> <paragraph num="(1)"> <text>A pregnant woman for the duration of her pregnancy and up to the last day of the month in which the infant turns 6 weeks old or the pregnancy ends;</text> </paragraph> <paragraph num="(2)"> <text>A postpartum woman up to the last day of the 6th month after the infant is born or the pregnancy ends;</text> </paragraph> <paragraph num="(3)"> <text>A breastfeeding woman up to the last day of the month of the breastfed infant’s first birthday as long as the woman is breastfeeding;</text> </paragraph> <paragraph num="(4)"> <text>An infant younger than 6 months old up to the last day of the month of the infant’s first birthday;</text> </paragraph> <paragraph num="(5)"> <text>An infant from 6 months old to 1 year old up to the last day of the 6th month from the date of certification; and</text> </paragraph> <paragraph num="(6)"> <text>A child 1 year old or older up to the last day of the month 1 year from the date of the certification or the month in which the child turns 5 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When there is difficulty in appointment scheduling for participants referred to in §A(4)—(6) of this regulation, a local agency may shorten or extend the certification period by not more than 30 days on a case-by-case basis.</text> </paragraph> <paragraph num="C."> <text>A local agency may use anthropometric data for a nutrition risk determination that precedes the date of certification by up to 60 days and bloodwork data following U.S. Centers for Disease Control and Prevention recommendations with no reduction in the length of certification.</text> </paragraph> <paragraph num="D."> <text>Anthropometric data for an individual certified as a pregnant woman shall be collected during the pregnancy, and data for an individual certified as a postpartum or a breastfeeding woman shall be collected after the termination of the pregnancy.</text> </paragraph> <paragraph num="E."> <text>Not less than 15 days before the expiration of a certification period, the Program shall notify a participant, or a child or infant participant's parent, guardian, or caretaker that the participant's certification period for the Program is about to expire.</text> </paragraph> <paragraph num="F."> <text>A participant, or a child or infant participant's parent, guardian, or caretaker shall apply in person for benefits for the next certification period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Action Affecting Participation During a Certification Period."> <paragraph num="A."> <text>A local agency may disqualify a participant in the middle of a certification period for Program abuse, which includes but is not limited to:</text> <paragraph num="(1)"> <text>The sale or exchange of food instruments or food obtained with a food instrument;</text> </paragraph> <paragraph num="(2)"> <text>Dual participation;</text> </paragraph> <paragraph num="(3)"> <text>Making false or misleading statements or intentionally misrepresenting, concealing, or withholding information in order to obtain benefits;</text> </paragraph> <paragraph num="(4)"> <text>Verbal or physical abuse of or threat of physical abuse to Program or vendor staff;</text> </paragraph> <paragraph num="(5)"> <text>Receipt from food vendors of cash or credit toward the purchase of unauthorized food or other items of value instead of authorized supplemental foods; and</text> </paragraph> <paragraph num="(6)"> <text>Failure to pick up food benefits for 2 consecutive issue months.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Funding Shortages.</text> <paragraph num="(1)"> <text>If the State agency experiences funding shortages, it may discontinue Program benefits to participants, but only after exploring alternative actions.</text> </paragraph> <paragraph num="(2)"> <text>The State agency may discontinue benefits by:</text> <paragraph num="(a)"> <text>Disqualifying a priority level of participants; or</text> </paragraph> <paragraph num="(b)"> <text>Withholding benefits to a priority level with the expectation of providing benefits again when funds are available.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When the State agency elects to restrict benefits to a priority level of participants due to insufficient funds for a period of time:</text> <paragraph num="(a)"> <text>The State agency shall discontinue benefits for:</text> <paragraph num="(i)"> <text>The least possible number of participants;</text> </paragraph> <paragraph num="(ii)"> <text>Those participants whose nutritional and health status would be least impaired by the discontinuation of Program benefits; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A local agency may not enroll new participants in restricted priority levels during this period.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Ineligibility. A local agency shall disqualify a participant in the middle of a certification period if, on the basis of a reassessment of Program eligibility status, the individual is determined ineligible for Program benefits.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Dual Participation."> <paragraph num="A."> <text>A participant may not engage in dual participation.</text> </paragraph> <paragraph num="B."> <text>The State agency in conjunction with the local agency is responsible for the detection and prevention within its program of dual participation.</text> </paragraph> <paragraph num="C."> <text>The local agency shall take immediate actions to investigate and resolve all incidents of suspected Program abuse involving dual participation.</text> </paragraph> <paragraph num="D."> <text>In order to prevent possible dual participation by an applicant, at certification the local agency shall verify the identity of each applicant and shall use the following to establish the identity of the infant or child applicant:</text> <paragraph num="(1)"> <text>Immunization record;</text> </paragraph> <paragraph num="(2)"> <text>Birth certificate; or</text> </paragraph> <paragraph num="(3)"> <text>Other record that the local agency considers adequate to establish the identity of an infant or child applicant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Applicant and Participant Rights and Responsibilities in the Certification Process."> <paragraph num="A."> <text>At the time of certification, a local agency shall inform an applicant or the parent, guardian, or caretaker of a child or infant applicant, of the following:</text> <paragraph num="(1)"> <text>The applicant may not engage in dual participation;</text> </paragraph> <paragraph num="(2)"> <text>The Program violations and the sanctions applicable to a participant, a child or infant participant's parent, guardian, or caretaker, or proxy for committing those violations;</text> </paragraph> <paragraph num="(3)"> <text>The importance of regularly picking up food benefits and food;</text> </paragraph> <paragraph num="(4)"> <text>The disqualification policy for failure to pick up food benefits and the number of months of nonparticipation resulting from the disqualification;</text> </paragraph> <paragraph num="(5)"> <text>The policy of not providing notification of disqualification to the participant when the participant fails to pick up food benefits;</text> </paragraph> <paragraph num="(6)"> <text>The right to a fair hearing if the participant does not agree with the disqualification for failure to pick up food benefits;</text> </paragraph> <paragraph num="(7)"> <text>How the local agency food delivery system operates and a list of authorized stores where food benefits may be redeemed;</text> </paragraph> <paragraph num="(8)"> <text>The available health services, where they are located, how they may be obtained, and why they may be useful;</text> </paragraph> <paragraph num="(9)"> <text>A participant or a child or infant participant’s parent, guardian, or caretaker shall notify the local agency of any change in life circumstances that would have an impact on Program eligibility; and</text> </paragraph> <paragraph num="(10)"> <text>A participant or a child or infant participant’s parent, guardian, or caretaker shall advise any designated proxy of the proxy’s obligations under the Program, Program violations, participant and proxy sanctions, and the authorized food stores.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At the time of certification, the Program applicant or a child or infant applicant’s parent, guardian, or caretaker shall read, or the Program representative or a local agency staff person shall read to the individual, the following:</text> <paragraph num="(1)"> <text>“The rules for applying for WIC are the same for everyone;”</text> </paragraph> <paragraph num="(2)"> <text>“I can ask a WIC employee for a fair hearing if someone tells me I cannot be on WIC and I do not agree;” and</text> </paragraph> <paragraph num="(3)"> <text>“I will get information about healthy eating and active living. WIC will help and support me with breastfeeding. I will get information about immunizations and other services I might need.”</text> </paragraph> </paragraph> <paragraph num="C."> <text>After advising the applicant, or the child or infant applicant’s parent, guardian, or caretaker of the rights and responsibilities set forth in this regulation, the applicant or the child or infant applicant’s parent, guardian, or caretaker, shall read, or a Program representative shall read to the applicant, or the child or infant applicant’s parent, guardian, or caretaker, the following statements:</text> <paragraph num="(1)"> <text>“I understand what my rights and responsibilities are;”</text> </paragraph> <paragraph num="(2)"> <text>“I agree to follow the rules below. I will:(i) not sell, give away or trade my eWIC card, foods, or formula for money, credit, rain checks or other items. If I have WIC items I can’t use, I will return them to the clinic; (ii) not post WIC items for sale or trade on the internet; (iii) not swear, yell, harass, threaten, physically harm WIC or store staff, or damage WIC or store property; (iv) not enroll a child who is not in my legal or designated care; and (v) not enroll in WIC in more than one state or get benefits from more than one WIC clinic each month;”</text> </paragraph> <paragraph num="(3)"> <text>“The information I have provided for eligibility determination is correct, to the best of my knowledge;”</text> </paragraph> <paragraph num="(4)"> <text>“The information that I provide to the WIC Program is being submitted in connection with the receipt of federal assistance;”</text> </paragraph> <paragraph num="(5)"> <text>“Program officials may verify information provided to them;”</text> </paragraph> <paragraph num="(6)"> <text>“I understand and agree that intentionally making a false or misleading statement or misrepresenting, hiding, or withholding facts may result in my having to pay the WIC Program, in cash, the value of the food benefits improperly issued to me and may subject me to civil or criminal prosecution under State and federal law and disqualification from the WIC Program;” and</text> </paragraph> <paragraph num="(7)"> <text>“I agree to give true and complete information about changes in my life circumstances that would have an impact on my eligibility for WIC benefits (for example, I will notify WIC if I have changes in my income or family size or if I move).”</text> </paragraph> </paragraph> <paragraph num="D."> <text>The applicant or the child or infant applicant’s parent, guardian, or caretaker, shall acknowledge the reading of the statements enumerated in §C of this regulation by signing the Rights and Responsibilities form provided by the State agency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Transfer of Certification."> <paragraph num="A."> <text>A local agency shall:</text> <paragraph num="(1)"> <text>Issue a verification of certification to a participant who:</text> <paragraph num="(a)"> <text>Is a member of a family in which there is a migrant farm worker; or</text> </paragraph> <paragraph num="(b)"> <text>Advises the local agency that the participant's family is likely to be relocating outside of Maryland during the certification period;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Ensure that each verification of certification contains the following:</text> <paragraph num="(a)"> <text>Name of the participant;</text> </paragraph> <paragraph num="(b)"> <text>Date the certification was performed;</text> </paragraph> <paragraph num="(c)"> <text>Date the income eligibility was last determined;</text> </paragraph> <paragraph num="(d)"> <text>Nutritional risk condition of the participant;</text> </paragraph> <paragraph num="(e)"> <text>Date the certification expires;</text> </paragraph> <paragraph num="(f)"> <text>Signature and printed or typed name of the local agency official who issued the verification of certification;</text> </paragraph> <paragraph num="(g)"> <text>The name and address of the certifying local agency; and</text> </paragraph> <paragraph num="(h)"> <text>An identification number for the verification of certification or some other means of accountability;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Accept a valid verification of certification from a participant of a WIC Program whether within or outside of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Accept the verification of certification or the copy of the State-approved certification form as proof of eligibility for WIC Program benefits until the participant’s certification period expires.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A local agency may not:</text> <paragraph num="(1)"> <text>Issue a verification of certification to an individual placed on the waiting list; or</text> </paragraph> <paragraph num="(2)"> <text>Deny participation in the Maryland WIC Program to an individual with a valid verification of certification because of a difference between another state’s and Maryland’s eligibility criteria.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A local agency may use the verification of certification as verification of income eligibility for the family of a migrant farm worker if the migrant farm worker is currently away from the migrant farm worker’s home jurisdiction, and if the migrant farm worker’s family income has been determined within the last 12 months.</text> </paragraph> <paragraph num="D."> <text>A local agency having a waiting list for participation that receives a transferring participant shall place the transferring participant ahead of waiting applicants without regard to priority level.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Receipt of Benefits."> <paragraph num="A."> <text>Nutrition Benefits. A local agency shall:</text> <paragraph num="(1)"> <text>Ensure that nutrition education is offered every 3 months to the participant or the parent, proxy, guardian, or caretaker of an infant or child participant during each certification period;</text> </paragraph> <paragraph num="(2)"> <text>Provide a nutrition care plan to the participant, based on the need for this plan as determined by a competent professional authority, and to a participant, parent, proxy, guardian, or caretaker who requests a nutrition care plan;</text> </paragraph> <paragraph num="(3)"> <text>Ensure that a competent professional authority or competent paraprofessional authority determines the selection of the food package according to the category and nutritional need of the participant; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the food package is consistent with foods allowed under the provisions of 7 CFR §246.10, which is incorporated by reference in Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Proxies.</text> <paragraph num="(1)"> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker is unable to pick up or redeem WIC benefits, the participant or the child or infant participant’s parent, guardian, or caretaker may name a proxy to pick up benefits, redeem them, or both.</text> </paragraph> <paragraph num="(2)"> <text>A participant or a child or infant participant's parent, guardian, or caretaker shall register the name of the proxy with the local agency before the proxy may perform any WIC-related activity.</text> </paragraph> <paragraph num="(3)"> <text>The Program may remove an individual who violates Program standards from serving as a proxy.</text> </paragraph> <paragraph num="(4)"> <text>A participant or a child or infant participant's parent, guardian, or caretaker may replace a proxy with another individual.</text> </paragraph> <paragraph num="(5)"> <text>A participant or a child or infant participant's parent, guardian, or caretaker shall advise a proxy of the:</text> <paragraph num="(a)"> <text>Proxy's obligations under the Program;</text> </paragraph> <paragraph num="(b)"> <text>Program violations;</text> </paragraph> <paragraph num="(c)"> <text>Participant and proxy sanctions; and</text> </paragraph> <paragraph num="(d)"> <text>Authorized food stores.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Receipt of Food Benefits.</text> <paragraph num="(1)"> <text>Except as provided in §B(3) and (4) of this regulation, a participant or the participant’s proxy shall report to a designated site at designated times to receive food benefits prepared for that participant and to acknowledge receipt of the benefits.</text> </paragraph> <paragraph num="(2)"> <text>When distributing food benefits, a local agency shall check a participant’s identification.</text> </paragraph> <paragraph num="(3)"> <text>A local agency may mail or otherwise deliver food benefits to participants on a local agency-wide basis if the State agency approves this action on the basis of a hardship that may be encountered by the target population, such as seasonally inclement weather.</text> </paragraph> <paragraph num="(4)"> <text>A local agency may mail or otherwise deliver food benefits to the participant or the participant’s parent, guardian, or caretaker who in writing requests this delivery and explains why it is necessary if a participant and the participant’s proxy are unable to report to the designated site to receive food benefits due to a hardship, including, but not limited to:</text> <paragraph num="(a)"> <text>Illness;</text> </paragraph> <paragraph num="(b)"> <text>Handicap;</text> </paragraph> <paragraph num="(c)"> <text>Imminent childbirth; or</text> </paragraph> <paragraph num="(d)"> <text>Difficulty of access to the site.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the hardship cited in §C(4) of this regulation does not allow time for a written request to be made, a local agency may act on a verbal request for the upcoming benefit distribution period only and shall follow the procedure set forth in §C(4) of this regulation if the hardship continues.</text> </paragraph> <paragraph num="(6)"> <text>When the hardship is resolved, a local agency shall continue with normal benefit issuance procedure.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Receipt and Consumption of Food.</text> <paragraph num="(1)"> <text>To obtain WIC-authorized foods, a participant or proxy shall complete transactions at WIC-authorized vendors.</text> </paragraph> <paragraph num="(2)"> <text>Only the participant for whom the food package was prescribed shall consume food obtained with a WIC food instrument.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctions."> <paragraph num="A."> <text>The Program may sanction a participant or proxy in the Program, in addition to seeking criminal or civil sanctions or other remedies that may be applicable under federal, State, or local law.</text> </paragraph> <paragraph num="B."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, has deliberately misrepresented the participant’s income, residence, family size, health status, medical data, or date of birth, the:</text> <paragraph num="(1)"> <text>Program shall disqualify the participant from the program for 1 year; and</text> </paragraph> <paragraph num="(2)"> <text>Offending party shall pay to the State agency, in cash, the value of food benefits improperly received.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If a participant or a child or infant participant’s parent, guardian, caretaker, or proxy obtains or attempts to obtain food benefits to which the participant is not entitled, sanctions shall be applied according to the following:</text> <paragraph num="(1)"> <text>If the offending party is a participant or a child or infant participant's parent, guardian, or caretaker:</text> <paragraph num="(a)"> <text>For the first offense, the Program shall counsel the individual and issue a warning letter;</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, the Program shall disqualify the participant from the Program for:</text> <paragraph num="(i)"> <text>3 months; or</text> </paragraph> <paragraph num="(ii)"> <text>1 year if the State agency assesses a monetary claim of $100 or more; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In either case in §C(1)(a) and (b) of this regulation, the offending party shall pay to the State agency, in cash, the value of the food benefits obtained; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the offending party is a proxy, the:</text> <paragraph num="(a)"> <text>Program shall remove the proxy; and</text> </paragraph> <paragraph num="(b)"> <text>Proxy shall pay to the State agency, in cash, the value of the food benefits obtained.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If a participant engages in dual participation as defined in Regulation .04B of this chapter:</text> <paragraph num="(1)"> <text>The Program shall counsel the participant or a child or infant participant’s parent, guardian, or caretaker, and disqualify the participant for 1 year; and</text> </paragraph> <paragraph num="(2)"> <text>The offending party shall pay to the State agency, in cash, the monetary value of the items received.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If a participant or a child or infant participant’s parent, guardian or caretaker, or a proxy physically abuses or threatens abuse of WIC or vendor staff, the Program shall:</text> <paragraph num="(1)"> <text>Report the incident to the police;</text> </paragraph> <paragraph num="(2)"> <text>Disqualify the participant from the Program for 1 year if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; and</text> </paragraph> <paragraph num="(3)"> <text>Remove the proxy if the offending party is a proxy.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy verbally abuses or harasses WIC or vendor staff, or disrupts the peaceful and orderly conduct of business at a WIC or vendor facility, the Program shall:</text> <paragraph num="(1)"> <text>For the first offense, disqualify the participant from the Program for 6 months;</text> </paragraph> <paragraph num="(2)"> <text>Remove the proxy if the offending party is a proxy; and</text> </paragraph> <paragraph num="(3)"> <text>For a subsequent offense, disqualify the participant from the Program for 1 year.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy sells or exchanges supplemental food purchased with a food instrument or sells a food instrument to another individual or entity, the:</text> <paragraph num="(1)"> <text>Program shall:</text> <paragraph num="(a)"> <text>Disqualify the participant for 3 months if the offending party is a participant or a child or infant participant's parent, guardian, or caretaker; or</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, disqualify the participant from the Program for 6 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker;</text> </paragraph> <paragraph num="(c)"> <text>Disqualify the offending party for 1 year if the State agency assesses a monetary claim of $100 or more; or</text> </paragraph> <paragraph num="(d)"> <text>Remove the proxy if the offending party is a proxy; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Offending party shall pay to the State agency, in cash, the monetary value of food or food instruments sold or exchanged.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy attempts to redeem or redeems a food instrument for unauthorized foods or for quantities of food in excess of that indicated on the food instrument, if the offending party is a:</text> <paragraph num="(1)"> <text>Participant or a child or infant participant’s parent, guardian, or caretaker:</text> <paragraph num="(a)"> <text>For the first offense, the Program shall counsel the individual and issue a warning letter;</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, the Program shall disqualify:</text> <paragraph num="(i)"> <text>The participant from the Program for 3 months; or</text> </paragraph> <paragraph num="(ii)"> <text>The offending party from the Program for 1 year if the State agency assesses a monetary claim of $100 or more; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>In either case in §H(1)(a) and (b) of this regulation, the offending party shall pay to the State agency, in cash, the value of the food benefits obtained; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Proxy, the:</text> <paragraph num="(a)"> <text>Program shall remove the proxy; and</text> </paragraph> <paragraph num="(b)"> <text>Proxy shall pay to the State agency, in cash, the value of the food benefits obtained.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy receives cash or credit toward the purchase of unauthorized food or other items of value instead of or in addition to authorized supplemental foods or exchanges, or attempts to exchange or returns or attempts to return authorized WIC food to the vendor for cash or non-WIC items, the:</text> <paragraph num="(1)"> <text>Program shall:</text> <paragraph num="(a)"> <text>Disqualify the participant from the Program for 3 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker;</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, disqualify the participant from the Program for 6 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; or</text> </paragraph> <paragraph num="(c)"> <text>Disqualify the offending party for 1 year if the State agency assesses a monetary claim of $100 or more;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Program shall remove the proxy if the offending party is a proxy; and</text> </paragraph> <paragraph num="(3)"> <text>Offending party shall pay to the State agency, in cash, the amount indicated on the food instrument with which the items were initially obtained, if the items were obtained.</text> </paragraph> </paragraph> <paragraph num="J."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy allows an unauthorized individual to use the Maryland WIC participant identification folder, if the offending party is a:</text> <paragraph num="(1)"> <text>Participant or a child or infant participant’s parent, guardian, or caretaker:</text> <paragraph num="(a)"> <text>For the first offense, the Program shall counsel the individual and issue a warning letter; and</text> </paragraph> <paragraph num="(b)"> <text>For a subsequent offense, the Program shall disqualify the participant from the Program for 3 months; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Proxy, the Program shall remove the proxy.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy fails to pay a monetary penalty imposed by the Program for redeeming food benefits, if the offending party is a:</text> <paragraph num="(1)"> <text>Participant or a child or infant participant’s parent, guardian, or caretaker, the Program shall disqualify the participant from the Program for 1 year; or</text> </paragraph> <paragraph num="(2)"> <text>Proxy, the Program shall remove the proxy.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Failure to Return Breast Pump.</text> <paragraph num="(1)"> <text>If a participant fails to return a hospital grade breast pump, the Program shall issue a warning letter to the participant.</text> </paragraph> <paragraph num="(2)"> <text>If a participant fails to return a hospital grade breast pump after receipt of a warning letter, the participant shall pay to the State agency, in cash, the monetary value of the breast pump.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Local and State Agency Sanction Responsibilities."> <paragraph num="A."> <text>A local agency shall implement participant and proxy sanctions and notify the State agency of the action taken.</text> </paragraph> <paragraph num="B."> <text>The State agency may also initiate participant and proxy sanctions and other acts based on information available to the State agency.</text> </paragraph> <paragraph num="C."> <text>Except for a participant the State agency disqualifies for failure to pick up food benefits, the State agency shall, not less than 15 days before disqualification, advise the participant in writing of the reasons for the disqualification and of the right to a fair hearing on the disqualification.</text> </paragraph> <paragraph num="D."> <text>When the State agency pursues collection of a claim against a participant who has been improperly issued food benefits, it shall advise the participant in writing of:</text> <paragraph num="(1)"> <text>The reasons for the claim;</text> </paragraph> <paragraph num="(2)"> <text>The value of the improperly issued benefits to be repaid to the Program;</text> </paragraph> <paragraph num="(3)"> <text>That the participant shall pay to the State agency, in cash, the value of the improperly issued benefits; and</text> </paragraph> <paragraph num="(4)"> <text>The participant's right to a fair hearing on the claim.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Appeal Procedures."> <paragraph num="A."> <text>Applicants and participants may appeal certain State or local agency actions.</text> </paragraph> <paragraph num="B."> <text>An applicant or participant:</text> <paragraph num="(1)"> <text>May appeal a State or local agency action resulting in the individual's being:</text> <paragraph num="(a)"> <text>Denied participation in the WIC Program;</text> </paragraph> <paragraph num="(b)"> <text>Instructed to repay the cash value of improperly issued benefits; or</text> </paragraph> <paragraph num="(c)"> <text>Disqualified from the Program; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall appeal the action in accordance with COMAR 10.01.06.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Nondiscrimination."> <paragraph num="A."> <text>Civil Rights Requirements.</text> <paragraph num="(1)"> <text>To ensure that an individual may not, on the grounds of race, color, national origin, age, sex, or handicap, be excluded from participation in, be denied benefits of, or be otherwise subjected to discrimination under the Program, a local agency shall comply with the requirements of:</text> <paragraph num="(a)"> <text>Title VI of the Civil Rights Act of 1964 as incorporated by reference in Regulation .03C of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Title IX of the Education Amendments of 1972 as incorporated by reference in Regulation .03C of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>§504 of the Rehabilitation Act of 1973 as incorporated by reference in Regulation .03C of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>The Age Discrimination Act of 1975 as incorporated by reference in Regulation .03C of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>USDA Food and Nutrition Service instructions issued by the Program to the local agencies; and</text> </paragraph> <paragraph num="(f)"> <text>USDA regulations on nondiscrimination as incorporated by reference in Regulation .03C of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A local agency shall:</text> <paragraph num="(a)"> <text>Notify the public of the nondiscrimination policy and complaint rights of a participant and an applicant as set forth in §B of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Review and monitor its activities to ensure Program compliance with the nondiscrimination laws and regulations; and</text> </paragraph> <paragraph num="(c)"> <text>Collect and report racial and ethnic participation data as required by Title VI of the Civil Rights Act of 1964, which prohibits discrimination in federally assisted programs on the basis of race, color, or national origin.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Complaints.</text> <paragraph num="(1)"> <text>An individual may submit to a local agency a complaint that alleges an incident of discrimination pursuant to §A of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The local agency shall forward to the State agency, within 10 days, the complaint which alleges discrimination.</text> </paragraph> <paragraph num="(3)"> <text>The State agency shall refer the complaint, including a complaint based on sex or handicap, to the USDA for investigation and necessary action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Non-English Materials."> <paragraph num="A."> <text>The Program shall accommodate the non-English-speaking individuals in the population eligible to be served as set forth in this chapter.</text> </paragraph> <paragraph num="B."> <text>When the population eligible to be served needs services or information in a language other than English in order to be informed of or to participate in the Program, the local agency shall:</text> <paragraph num="(1)"> <text>Take reasonable steps to provide Program information in the appropriate language; and</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the rights and responsibilities listed on the certification form are read to the applicant in the appropriate language.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Conflict of Laws and Regulations."> <text>If the provisions of this chapter conflict with federal statutes and regulations, including the provisions incorporated by reference in Regulation .03 of this chapter, the federal statutes and regulations prevail.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §18-107(a), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective February 21, 1986 (13:6 Md. R. 670); emergency status expired May 31, 1986</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective June 4, 1986 (13:13 Md. R. 1477); adopted permanently effective October 20, 1986 (13:21 Md. R. 2321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C, E amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 19, 1990 (17:5 Md. R. 638)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 repealed and Regulations .01—.24 adopted effective March 25, 1996 (23:6 Md. R. 476)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 494); May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07D amended effective November 29, 1999 (26:24 Md. R. 1858)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, B amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A, G amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, B, C amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective March 31, 2014 (41:6 Md. R. 380); May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C, D amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> </annotations> </chapter> <chapter num="02" heading="Local Agency"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations are promulgated to specify the selection and the responsibilities of a local agency, and the rate of payment to a local agency in the administration of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program or Program), operated by the Maryland Department of Health with funding substantially provided by the U.S. Department of Agriculture under §17 of the Child Nutrition Act of 1966, 42 U.S.C. §1786.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <text>The terms defined in COMAR 10.54.01.04 also apply to this chapter.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Selection of a Local Agency."> <text>The State agency shall select a local agency in accordance with the following priorities:</text> <paragraph num="A."> <text>First consideration shall be given to a public or a private nonprofit health agency that will provide ongoing, routine pediatric and obstetric care and administrative services;</text> </paragraph> <paragraph num="B."> <text>Second consideration shall be given to a public or private nonprofit health or human service agency that will enter into a written agreement with another agency for either ongoing, routine pediatric and obstetric care or administrative services;</text> </paragraph> <paragraph num="C."> <text>Third consideration shall be given to a public or private nonprofit health agency that will enter into a written agreement with private physicians licensed by the State in order to provide ongoing, routine pediatric and obstetric care to a specific category of participants (women, infants, or children);</text> </paragraph> <paragraph num="D."> <text>Fourth consideration shall be given to a public or private nonprofit human service agency that will enter into a written agreement with private physicians licensed by the State to provide ongoing, routine pediatric and obstetric care; and</text> </paragraph> <paragraph num="E."> <text>Fifth consideration shall be given to a public or private nonprofit health or human service agency that will provide ongoing, routine pediatric and obstetric care through referral to a health care provider.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Duties and Responsibilities."> <text>To participate in the Program, a local agency shall:</text> <paragraph num="A."> <text>Comply with the fiscal and operational requirements prescribed by the State agency or the federal government in:</text> <paragraph num="(1)"> <text>This chapter;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.54.01;</text> </paragraph> <paragraph num="(3)"> <text>7 CFR Part 3015;</text> </paragraph> <paragraph num="(4)"> <text>7 CFR Part 3016; and</text> </paragraph> <paragraph num="(5)"> <text>7 CFR Part 246;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Maintain the caseload within the prescribed performance standards of the State-assigned level over a prescribed time period as specified in the written agreement between the State agency and the local agency;</text> </paragraph> <paragraph num="C."> <text>Inform the State agency on a timely basis of clinic sites and hours of operation;</text> </paragraph> <paragraph num="D."> <text>Make available, contract to make available, or provide by referral, appropriate health services to participants and inform applicants of the health services which are available;</text> </paragraph> <paragraph num="E."> <text>Devise and implement a plan to make health services available to participants at the clinic or through written agreements with health care providers when health services are provided through referral;</text> </paragraph> <paragraph num="F."> <text>Provide Program benefits to the participant at no cost;</text> </paragraph> <paragraph num="G."> <text>Perform the certification procedure at no cost to the applicant;</text> </paragraph> <paragraph num="H."> <text>Have on its staff a competent professional authority as defined at COMAR 10.54.01.04;</text> </paragraph> <paragraph num="I."> <text>Maintain on file and have available for review, audit, and evaluation all criteria used for certification, including information on the:</text> <paragraph num="(1)"> <text>Area served;</text> </paragraph> <paragraph num="(2)"> <text>Income standards used; and</text> </paragraph> <paragraph num="(3)"> <text>Specific criteria used to determine nutritional risk;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Provide nutrition education services to participants, in compliance with all State and federal statutes and regulations including:</text> <paragraph num="(1)"> <text>Regulation .06 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>7 CFR 246; and</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.54.01;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Implement and operate a food delivery system prescribed by the State agency pursuant to these regulations and approved by the Food and Nutrition Service of the U.S. Department of Agriculture;</text> </paragraph> <paragraph num="L."> <text>Maintain complete, accurate, documented, and current accounting of all Program funds received and expended;</text> </paragraph> <paragraph num="M."> <text>Establish an internal monitoring system to review local agency operations and its associated clinics or contractors;</text> </paragraph> <paragraph num="N."> <text>Provide orientation and ongoing in-service training for staff;</text> </paragraph> <paragraph num="O."> <text>Inform the State agency of the content and schedule of training activities;</text> </paragraph> <paragraph num="P."> <text>Make staff available to attend training sessions offered by the State agency; and</text> </paragraph> <paragraph num="Q."> <text>Compile data, maintain records, and submit reports as required to permit effective enforcement of nondiscrimination laws and regulations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Certification Process."> <text>A local agency shall:</text> <paragraph num="A."> <text>Certify an applicant as eligible for the Program according to the policies and procedures prescribed in COMAR 10.54.01;</text> </paragraph> <paragraph num="B."> <text>Inform an applicant or participant, or a parent or caretaker, of the participant’s rights and responsibilities and the Program benefits as prescribed in COMAR 10.54.01.16 and .18; and</text> </paragraph> <paragraph num="C."> <text>Maintain historical participant case files which shall include at least the following information obtained at each certification:</text> <paragraph num="(1)"> <text>Information regarding income documentation as required by COMAR 10.54.01.07;</text> </paragraph> <paragraph num="(2)"> <text>Anthropometric measurements of height and weight;</text> </paragraph> <paragraph num="(3)"> <text>A hematological test result as required by COMAR 10.54.01.08E;</text> </paragraph> <paragraph num="(4)"> <text>The local agency copy of the form developed by the Department outlining the rights and responsibilities of the applicant or participant and the form signed by the:</text> <paragraph num="(a)"> <text>Applicant;</text> </paragraph> <paragraph num="(b)"> <text>Parent; or</text> </paragraph> <paragraph num="(c)"> <text>Caretaker; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Documentation of the nutrition education contacts, including the:</text> <paragraph num="(a)"> <text>Date; and</text> </paragraph> <paragraph num="(b)"> <text>Nutrition education content.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Nutrition Education."> <paragraph num="A."> <text>A local agency shall provide nutrition education or a local agency shall enter into an agreement with another agency to provide nutrition education.</text> </paragraph> <paragraph num="B."> <text>If nutrition education is provided by another agency, then the local agency shall:</text> <paragraph num="(1)"> <text>Acknowledge the nutrition education agreement in the nutrition education plan to the State agency;</text> </paragraph> <paragraph num="(2)"> <text>Ensure proper training to the individual or individuals rendering the services; and</text> </paragraph> <paragraph num="(3)"> <text>Monitor the services rendered.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A local agency shall ensure that nutrition education is:</text> <paragraph num="(1)"> <text>Made available at no cost to the participant;</text> </paragraph> <paragraph num="(2)"> <text>Practical and relevant to the participant's individual needs; and</text> </paragraph> <paragraph num="(3)"> <text>Integrated into:</text> <paragraph num="(a)"> <text>Participant health care plans;</text> </paragraph> <paragraph num="(b)"> <text>The delivery of supplemental foods; and</text> </paragraph> <paragraph num="(c)"> <text>Other Program operations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>To carry out the nutrition education responsibilities, a local agency shall:</text> <paragraph num="(1)"> <text>Develop and submit for State agency approval an annual nutrition education plan;</text> </paragraph> <paragraph num="(2)"> <text>Make available at reasonable times and locations during each 1-year certification period at least four opportunities for nutrition education for the:</text> <paragraph num="(a)"> <text>Adult participant;</text> </paragraph> <paragraph num="(b)"> <text>Parent or caretaker of an infant or child participant; and</text> </paragraph> <paragraph num="(c)"> <text>Child participant whenever possible;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Document in each participant’s file, at the time of certification or recertification, all nutrition education sessions given to the participant, parent, caretaker, or child;</text> </paragraph> <paragraph num="(4)"> <text>Document the participant’s, parent’s, caretaker’s, or child’s refusal or inability to attend or participate in nutrition education for purposes of further education efforts and monitoring as specified by the State agency; and</text> </paragraph> <paragraph num="(5)"> <text>Provide an individual care plan for a participant when the need for a plan is determined by a competent professional authority or when a participant, parent, or caretaker requests an individual care plan.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Food Delivery."> <paragraph num="A."> <text>General Provisions. A local agency shall:</text> <paragraph num="(1)"> <text>Implement and operate a food delivery system according to the local agency's agreement with the State agency;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that the food delivery system's operation is compatible with the delivery of health and nutrition education services;</text> </paragraph> <paragraph num="(3)"> <text>Inform a participant or the parent or caretaker of an infant or child participant of the authorized vendors within the local agency service area;</text> </paragraph> <paragraph num="(4)"> <text>Issue food instruments to participants or the participant's parent, caretaker, or proxy in accordance with COMAR 10.54.01; and</text> </paragraph> <paragraph num="(5)"> <text>Ensure that a participant or the participant’s parent, caretaker, or proxy signs for receipt of food instruments.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Vendor Authorization. The State agency, in conjunction with a local agency, shall:</text> <paragraph num="(1)"> <text>Determine the appropriate number and distribution of vendors needed to serve the participants within the area served by the local agency; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct and provide documentation of on-site visits to an applicant vendor.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Vendor Agreements. A local agency shall abide by the vendor agreement or agreements authorized for use in the local agency by the State agency.</text> </paragraph> <paragraph num="D."> <text>Vendor Training. A local agency shall provide training to a vendor when required by the State agency.</text> </paragraph> <paragraph num="E."> <text>Vendor Monitoring. A local agency, in conjunction with the State agency, shall:</text> <paragraph num="(1)"> <text>Conduct on-site monitoring visits to at least 10 percent of the authorized vendors per year, selected on a representative basis, and submit to the State agency a summary of the results;</text> </paragraph> <paragraph num="(2)"> <text>Identify and monitor vendors who present the potential for abuse of the Program and submit to the State agency a summary of the results;</text> </paragraph> <paragraph num="(3)"> <text>Ensure investigation of suspected fraud and abuse and of complaints against participants as well as complaints by participants; and</text> </paragraph> <paragraph num="(4)"> <text>Recommend sanctioning of vendors as prescribed at COMAR 10.54.03.16.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Food Instruments Accountability. A local agency shall control and provide accountability for the receipt and issuance of food instruments.</text> </paragraph> <paragraph num="G."> <text>Conflict of Interest. A local agency shall notify the State agency if any conflict of interest appears to exist between the local agency or a member of its staff and a vendor within its jurisdiction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Financial Management System."> <text>A local agency shall:</text> <paragraph num="A."> <text>Maintain records that identify the source and use of funds expended for Program activities and which contain information pertaining to:</text> <paragraph num="(1)"> <text>Authorization;</text> </paragraph> <paragraph num="(2)"> <text>Receipt of funds;</text> </paragraph> <paragraph num="(3)"> <text>Obligations;</text> </paragraph> <paragraph num="(4)"> <text>Unobligated balances;</text> </paragraph> <paragraph num="(5)"> <text>Assets;</text> </paragraph> <paragraph num="(6)"> <text>Liabilities;</text> </paragraph> <paragraph num="(7)"> <text>Outlays; and</text> </paragraph> <paragraph num="(8)"> <text>Income; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Implement procedures which ensure prompt and accurate payment of allowable costs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Program Costs — General."> <text>A local agency may have the following administrative and program services costs:</text> <paragraph num="A."> <text>Direct costs, as allowed under 7 CFR Part 3016, which are identifiable costs incurred exclusively for the purpose of the Program; and</text> </paragraph> <paragraph num="B."> <text>Indirect costs, as allowed by 7 CFR Part 3016, which are those costs incurred for a common purpose benefitting more than one program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Allowable Administrative and Program Service Costs."> <paragraph num="A."> <text>Expenditures for Nutrition Education.</text> <paragraph num="(1)"> <text>During each federal fiscal year, a local agency shall use for nutrition education an amount equal to at least 20 percent of the administrative award set forth in §B of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>A local agency may not apply the cost of dietary assessments for purposes of certification and the cost of prescribing and issuing supplemental foods to the 20 percent minimum amount required to be spent on nutrition education.</text> </paragraph> <paragraph num="(3)"> <text>A local agency may apply the following to the 20 percent minimum amount required to be spent on nutrition education:</text> <paragraph num="(a)"> <text>Salary and other costs for time spent on nutrition education consultation, whether with an individual or group;</text> </paragraph> <paragraph num="(b)"> <text>The cost of procuring, producing, and distributing nutrition education materials including the cost of:</text> <paragraph num="(i)"> <text>Handouts;</text> </paragraph> <paragraph num="(ii)"> <text>Flip charts;</text> </paragraph> <paragraph num="(iii)"> <text>Videos;</text> </paragraph> <paragraph num="(iv)"> <text>Food models or other teaching aids; and</text> </paragraph> <paragraph num="(v)"> <text>Mailing nutrition education material to participants;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Salary and other costs incurred in developing the local agency's annual nutrition education plan; and</text> </paragraph> <paragraph num="(d)"> <text>Other costs that can be justified by the local agency to the State agency as related to nutrition education.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Expenditures for Administrative Costs. A local agency may incur costs for the following administrative services:</text> <paragraph num="(1)"> <text>Outreach;</text> </paragraph> <paragraph num="(2)"> <text>Interpreters;</text> </paragraph> <paragraph num="(3)"> <text>Translators; and</text> </paragraph> <paragraph num="(4)"> <text>Fair hearings including the cost of an independent medical assessment of an appellant, when ordered by an administrative law judge.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Cost of Program Certification Procedures. A local agency may incur the following program certification costs:</text> <paragraph num="(1)"> <text>Laboratory fees for tests conducted to determine whether an individual is at nutritional risk;</text> </paragraph> <paragraph num="(2)"> <text>The cost of expendable medical supplies necessary to determine whether an individual is at nutritional risk;</text> </paragraph> <paragraph num="(3)"> <text>The cost of medical equipment used in connection with a nutritional risk determination to take anthropometric measurements, such as scales, measuring boards, and medical equipment used for analysis to detect anemia; and</text> </paragraph> <paragraph num="(4)"> <text>Salary and other costs for time spent on certification.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prior Approved Costs. A local agency may incur the following allowable costs only with prior approval from the State agency:</text> <paragraph num="(1)"> <text>Data processing costs which are required by the local agency, except for those used in general management and payroll, including acquisition of automatic data processing hardware or software whether by outright purchase, retail purchase agreement, or other method of acquisition;</text> </paragraph> <paragraph num="(2)"> <text>Capital expenditures over $5,000, such as the cost of facilities, equipment, including medical equipment, other capital assets, and any repairs that materially increase the value or useful life of capital assets; and</text> </paragraph> <paragraph num="(3)"> <text>Management studies performed by an agency, or department other than the local agency, or those performed by an outside consultant under contract with the local agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Monitoring and Review."> <paragraph num="A."> <text>Management Evaluation and Reviews. Every 2 years the State agency shall conduct a monitoring review of each local agency, including an on-site review of a minimum of 20 percent of the clinics in a local agency or one clinic, whichever is greater. This review shall encompass, but not be limited to, the evaluation of:</text> <paragraph num="(1)"> <text>Management;</text> </paragraph> <paragraph num="(2)"> <text>Certification;</text> </paragraph> <paragraph num="(3)"> <text>Nutrition education;</text> </paragraph> <paragraph num="(4)"> <text>Civil rights compliance;</text> </paragraph> <paragraph num="(5)"> <text>Accountability;</text> </paragraph> <paragraph num="(6)"> <text>Financial management systems; and</text> </paragraph> <paragraph num="(7)"> <text>Food delivery systems.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Periodic Review of a Local Agency's Qualifications.</text> <paragraph num="(1)"> <text>The State agency may conduct periodic reviews of the qualifications of an authorized local agency.</text> </paragraph> <paragraph num="(2)"> <text>Based upon the results of the reviews in §B(1) of this regulation, the State agency may take appropriate action, including the disqualification of a local agency.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Investigations. The State agency shall investigate any allegation of a local agency's noncompliance with State and federal Program statutes and regulations.</text> </paragraph> <paragraph num="D."> <text>Local Agency Audits.</text> <paragraph num="(1)"> <text>The Department may arrange for an audit by an entity independent from the Department.</text> </paragraph> <paragraph num="(2)"> <text>The audit in §D(1) of this regulation may go beyond the management evaluation of the financial operation of a local agency.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Disqualification of a Local Agency."> <text>The State agency may disqualify a local agency when the:</text> <paragraph num="A."> <text>State agency determines a local agency's noncompliance with Program regulations;</text> </paragraph> <paragraph num="B."> <text>State's Program funds are insufficient to support the continued operation of the Program's existing local agencies at the agencies' current participation level; or</text> </paragraph> <paragraph num="C."> <text>State agency determines, following a review of local agency credentials in accordance with Regulation .11B of this chapter, that another local agency can operate the Program more effectively and efficiently.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Claims and Penalties."> <paragraph num="A."> <text>If the State agency determines through a review of a local agency's reports, program or financial analysis, monitoring, audit, or other means, that Program funds provided to a local agency for administrative and program services purposes were, through the local agency's negligence or fraud, misused or otherwise diverted from Program purposes, the State agency shall make a claim against the local agency.</text> </paragraph> <paragraph num="B."> <text>The local agency shall pay the State agency a sum equal to the amount of misused or diverted administrative and program services funds and the face value of food misused or diverted instruments, or both.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Records and Reports."> <paragraph num="A."> <text>A local agency shall:</text> <paragraph num="(1)"> <text>Maintain full and complete records concerning Program operations;</text> </paragraph> <paragraph num="(2)"> <text>Establish and maintain records concerning:</text> <paragraph num="(a)"> <text>Financial operations;</text> </paragraph> <paragraph num="(b)"> <text>Food delivery systems;</text> </paragraph> <paragraph num="(c)"> <text>Food instrument issuance;</text> </paragraph> <paragraph num="(d)"> <text>Equipment purchases;</text> </paragraph> <paragraph num="(e)"> <text>Inventory;</text> </paragraph> <paragraph num="(f)"> <text>Certification;</text> </paragraph> <paragraph num="(g)"> <text>Nutrition education;</text> </paragraph> <paragraph num="(h)"> <text>Civil rights;</text> </paragraph> <paragraph num="(i)"> <text>Fair hearing procedures; and</text> </paragraph> <paragraph num="(j)"> <text>Other information as specified by the State agency;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Retain all records for a minimum of 4 years following the date of submission of the final expenditure report for the period to which the report pertains;</text> </paragraph> <paragraph num="(4)"> <text>Except for medical case records of individual participants, unless they are the only source of certification data, make available for review, audit, or copying during normal business hours, records for:</text> <paragraph num="(a)"> <text>Representatives of the Comptroller General of the United States, U.S. Department of Agriculture's Office of the Inspector General, Food and Consumer Service (FCS) of the U.S. Department of Agriculture; and</text> </paragraph> <paragraph num="(b)"> <text>State-authorized personnel;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Submit a quarterly expenditure report on a form specified by the Department within 30 days after the end of the quarter being reported;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that, for the purposes of an audit, the quarterly expenditure report is documented so that it can be traced to its source; and</text> </paragraph> <paragraph num="(7)"> <text>Designate a person who shall certify the quarterly expenditure report as to its completeness and accuracy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A local agency may not divulge individual names in any report issued.</text> </paragraph> <paragraph num="C."> <text>The State agency or a local agency shall:</text> <paragraph num="(1)"> <text>Forward Program records to the Food and Nutrition Service of the U.S. Department of Agriculture whenever either agency is disposing of them, if the Food and Nutrition Service of the U.S. Department of Agriculture considers any of the records to be of historical interest; and</text> </paragraph> <paragraph num="(2)"> <text>Retain a record for nonexpendable property acquired in whole or in part with Program funds for 3 years after final disposition of the property.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If any litigation, claim, negotiation, audit, or other action involving the records specified in §A(2) of this regulation has been started before the end of the 3-year period, a local agency shall keep the records until all issues are resolved, or until the end of the regular 3-year period, whichever is later.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Appeal Procedures."> <text>A local agency filing an appeal from an administrative decision made in connection with these regulations shall do so in accordance with COMAR 10.01.06.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Conflict of State and Federal Law and Regulation."> <text>If a provision of this chapter conflicts with a federal statute or regulation, the federal statute or regulation prevails.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Program Information Disclosure."> <paragraph num="A."> <text>The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency reserve the right to use information obtained under the Program in a summary, statistical, or other form which does not identify an individual client.</text> </paragraph> <paragraph num="B."> <text>The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency may require the local agency to supply medical data and other information collected under the Program, in a form that does not identify individual clients, to enable the United States Department of Agriculture or the State agency to evaluate the effect of food intervention upon low income individuals determined to be at nutritional risk.</text> </paragraph> <paragraph num="C."> <text>A local agency shall protect the confidentiality of information obtained from a Program applicant or participant and shall disclose this information only to:</text> <paragraph num="(1)"> <text>An individual directly connected with the administration or enforcement of the Program, including an individual investigating or prosecuting violations in the WIC Program under federal, State, or local authority;</text> </paragraph> <paragraph num="(2)"> <text>A representative of a public organization with whom the State agency has executed a written agreement pursuant to 7 CFR §246.26; and</text> </paragraph> <paragraph num="(3)"> <text>The Comptroller General of the United States for audit and examination authorized by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Payment to a Local Agency."> <paragraph num="A."> <text>The funds awarded by the Department to a local agency are based on the caseload to be served and are subject to the availability of federal funds.</text> </paragraph> <paragraph num="B."> <text>Funding rates will be updated annually and available from the Department.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§18-107(a) and 18-108, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 30, 1992 (19:6 Md. R. 674)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); amended permanently effective January 9, 1994 (20:20 Md. R. 1572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04, .10, .14, .17, and .18 amended as an emergency provision effective June 29, 1996 (23:15 Md. R. 1083); amended permanently effective October 21, 1996 (23:21 Md. R. 1468)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B, C amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07F, .10A, .14A, and .18C amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1532)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, C amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11D amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective April 16, 2012 (39:7 Md. R. 494)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A, B amended effective May 18, 2020 (47:10 Md. R. 519)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 adopted as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); adopted permanently effective January 9, 1994 (20:20 Md. R. 1572)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective August 26, 1999 (26:19 Md. R. 1446); amended permanently effective November 15, 1999 (26:23 Md. R. 1777)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective November 13, 2000 (27:22 Md. R. 2060)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1685)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective July 1, 2010 (37:16 Md. R. 1058); amended permanently effective October 4, 2010 (37:20 Md. R. 1394)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective July 1, 2012 (39:17 Md. R. 1145); amended permanently effective October 15, 2012 (39:20 Md. R. 1306)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective July 19, 2013 (40:17 Md. R. 1418); emergency status extended to February 3, 2014 (41:2 Md. R. 89); amended permanently effective January 6, 2014 (40:26 Md. R. 2164)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended as an emergency provision effective August 28, 2014 (41:19 Md. R. 1075); amended permanently effective November 10, 2014 (41:22 Md. R. 1319); December 8, 2016 (43:24 Md. R. 1350)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective March 26, 2018 (45:6 Md. R. 321)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1380); amended permanently effective October 24, 1994 (21:21 Md. R. 1814)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B amended as an emergency provision effective July 1, 1997 (24:15 Md. R. 1060); amended permanently effective October 20, 1997 (24:21 Md. R. 1451)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1116); amended permanently effective October 9, 1995 (22:20 Md. R. 1543)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective December 22, 2003 (30:25 Md. R. 1848)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1252); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2005 (32:15 Md. R. 1314); amended permanently effective October 10, 2005 (32:20 Md. R. 1656)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1150); amended permanently effective August 27, 2007 (34:17 Md. R. 1509)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective June 26, 2008 (35:15 Md. R. 1345); amended permanently effective October 6, 2008 (35:20 Md. R. 1776)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2009 (36:15 Md. R. 1164); amended permanently effective September 7, 2009 (36:18 Md. R. 1382)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective July 1, 2011 (38:19 Md. R. 1146); amended permanently effective October 17, 2011 (38:21 Md. R. 1279)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, C amended as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); amended permanently effective October 26, 2015 (42:21 Md. R. 1302)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18E adopted as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); adopted permanently effective October 26, 2015 (42:21 Md. R. 1302)</annotation> </annotations> </chapter> <chapter num="03" heading="Retail Food and Pharmacy Vendors"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter specifies the policies and procedures for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to authorize vendors to redeem WIC food instruments and provide foods to WIC participants.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Incorporations by Reference."> <text>In this chapter, the following documents are incorporated by reference:</text> <paragraph num="A."> <text>42 U.S.C. §1786, as amended; and</text> </paragraph> <paragraph num="B."> <text>7 CFR 15-15b and 246, as amended.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Above 50 percent vendor” means a vendor that derives or will derive after commencement of business more than 50 percent of the vendor's annual eligible food sales revenue from WIC food instruments.</text> </paragraph> <paragraph num="(2)"> <text>“Accounting records” means:</text> <paragraph num="(a)"> <text>Legible records that show actual numbers of eligible food sales from the vendor and not an estimated number or percentage of eligible food sales; and</text> </paragraph> <paragraph num="(b)"> <text>Actual WIC sales for each individual day.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Approved foods” means the types and brands of foods:</text> <paragraph num="(a)"> <text>Approved by the State agency for use by Program participants;</text> </paragraph> <paragraph num="(b)"> <text>Included on the Maryland WIC Authorized Foods List; and</text> </paragraph> <paragraph num="(c)"> <text>Included in the Approved Product List (APL).</text> </paragraph> </paragraph> <paragraph num="(4-1)"> <text>“Approved Product List (APL)” means the electronic list of approved foods maintained by the State agency.</text> </paragraph> <paragraph num="(4-2)"> <text>“Authorization” means approval by the State agency for a food store, pharmacy only, food store/pharmacy combination, or a military commissary to redeem WIC food instruments as a vendor.</text> </paragraph> <paragraph num="(4-3)"> <text>“Benefits” means the foods prescribed and services provided to a participant by the Program.</text> </paragraph> <paragraph num="(5)"> <text>“Change in ownership” means the transfer of majority control or ownership of a store.</text> </paragraph> <paragraph num="(6)"> <text>“Compliance buy” means a covert, on-site investigation in which a representative of the Program:</text> <paragraph num="(a)"> <text>Poses as a:</text> <paragraph num="(i)"> <text>Participant;</text> </paragraph> <paragraph num="(ii)"> <text>Parent, guardian, or caretaker of an infant or child participant; or</text> </paragraph> <paragraph num="(iii)"> <text>Proxy;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Presents one or more food instruments to be redeemed for food; and</text> </paragraph> <paragraph num="(c)"> <text>Does not reveal during the visit that the individual is a Program representative.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Day” means a calendar day.</text> </paragraph> <paragraph num="(8)"> <text>“Disqualification” means revocation of a vendor's WIC authorization for a specified period of time as prescribed in Regulation .16 of this chapter.</text> </paragraph> <paragraph num="(9)"> <text>“Excess charges” means the amount above the maximum price payable for the food benefits charged by a vendor to the Program.</text> </paragraph> <paragraph num="(10)"> <text>“Exempt infant formulas” means those infant formulas available, which are not categorized as either contract or noncontract, standard infant formulas.</text> </paragraph> <paragraph num="(11)"> <text>“Food instrument” means an electronic benefits issuance card or other document that is used to obtain supplemental foods.</text> </paragraph> <paragraph num="(12)"> <text>“Food package” means a grouping of specified types and amounts of foods, as set forth in Regulation .06A of this chapter, used for the purpose of evaluating vendor prices.</text> </paragraph> <paragraph num="(13)"> <text>“Food sales” means sales of all SNAP eligible foods intended for home preparation and consumption, as set forth in 7 CFR §246.2.</text> </paragraph> <paragraph num="(14)"> <text>“Food store” means a grocery or supermarket licensed under COMAR 10.15.03 that ordinarily has, for sale to the public, authorized foods and does not have a pharmacy under the same ownership on its premises.</text> </paragraph> <paragraph num="(15)"> <text>“Food store/pharmacy combination” means a food store and a pharmacy under the same ownership on the same premises.</text> </paragraph> <paragraph num="(16)"> <text>“High risk” means a vendor has been determined by the State agency to have a high probability of violating program requirements.</text> </paragraph> <paragraph num="(17)"> <text>“Inventory audit” means an audit conducted over a specific period of time in order to determine whether a vendor’s claimed reimbursement for the sale of an amount of a specific food item exceeds the vendor’s documented inventory of that item.</text> </paragraph> <paragraph num="(18)"> <text>“Inventory invoices” mean sales receipts for WIC food purchased by the vendor for resale by the vendor, from a supplier which can be a wholesaler, distributor, manufacturer, or other retailer.</text> </paragraph> <paragraph num="(19)"> <text>“Maximum price payable” means the maximum amount of money the Program will pay a vendor for the WIC food items on the food instrument.</text> </paragraph> <paragraph num="(20)"> <text>“Medical foods” means WIC-eligible formula authorized for children and women with special dietary needs.</text> </paragraph> <paragraph num="(21)"> <text>“Minimum required stock” means the specific types and amounts of WIC-authorized foods that shall be in a vendor's store during business hours.</text> </paragraph> <paragraph num="(22)"> <text>“Monitoring” means assessing vendor compliance with program requirements.</text> </paragraph> <paragraph num="(23)"> <text>“Nonprofit entity” means a vendor applicant or vendor whose business has been granted a 26 U.S.C. §501(c)(3) federal income tax exemption by the United States Internal Revenue Service.</text> </paragraph> <paragraph num="(24)"> <text>“On-site review” means an inspection of a vendor applicant's premises by a Program representative to ensure that requirements for authorization are met.</text> </paragraph> <paragraph num="(25)"> <text>“Participant” means a pregnant woman, a breastfeeding woman, a postpartum woman, an infant, a breastfed infant of a participant breastfeeding woman, or a child receiving supplemental foods or food benefits from the Program.</text> </paragraph> <paragraph num="(26)"> <text>“Pattern” means two or more vendor violations of the same provision.</text> </paragraph> <paragraph num="(27)"> <text>“Peer group” means a grouping of stores with similar characteristics and business practices that correlate to food costs.</text> </paragraph> <paragraph num="(28)"> <text>“Peer group average” means the arithmetic mean of prices charged by vendors within a peer group for food items.</text> </paragraph> <paragraph num="(29)"> <text>“Pharmacy only” means an establishment that:</text> <paragraph num="(a)"> <text>Has been issued a permit to operate by the State Board of Pharmacy; and</text> </paragraph> <paragraph num="(b)"> <text>Does not have a food store under the same ownership on its premises.</text> </paragraph> </paragraph> <paragraph num="(29-1)"> <text>“PIN” means a personal identification number used to securely access benefits on the food instrument.</text> </paragraph> <paragraph num="(30)"> <text>“Program” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended, including the local, State, and federal entities that administer it.</text> </paragraph> <paragraph num="(31)"> <text>“Proxy” means an individual who is designated by a participant or a child, or infant participant’s parent, guardian, or caretaker to receive food instruments and to redeem food benefits for the participant and whose name is on file at a local agency.</text> </paragraph> <paragraph num="(32)"> <text>“Region” means a designated area of the State for administration of the WIC Program including vendor selection and peer group designation.</text> </paragraph> <paragraph num="(33)"> <text>“Standard infant formulas” means nutritionally complete infant formulas which do not require the addition of any ingredient other than water before being served in a liquid state and which supply at least 10 milligrams of iron per liter at standard dilution and approximately 20 kilocalories per fluid ounce at standard dilution.</text> </paragraph> <paragraph num="(34)"> <text>“State agency” means the Maryland Department of Health's WIC Program.</text> </paragraph> <paragraph num="(35)"> <text>“Store” means a food store, pharmacy, food store/pharmacy combination, or military commissary.</text> </paragraph> <paragraph num="(36)"> <text>“Supplemental Nutrition Assistance Program (SNAP)” means the federal program administered by the United States Department of Agriculture that provides financial assistance for purchasing food.</text> </paragraph> <paragraph num="(37)"> <text>“Traffic” means to buy or sell a food instrument or benefits for cash.</text> </paragraph> <paragraph num="(38)"> <text>“Universal Product Code (UPC)” means a unique barcode assigned to a trade item and used to track items for sale in stores, such as food.</text> </paragraph> <paragraph num="(39)"> <text>“USDA” means the United States Department of Agriculture.</text> </paragraph> <paragraph num="(40)"> <text>“Vendor” means a sole proprietorship, partnership, cooperative association, corporation, or other business entity operating one or more stores authorized by the State agency to provide authorized supplemental foods to participants under a retail food delivery system.</text> </paragraph> <paragraph num="(41)"> <text>“Vendor agreement” means a written agreement between the State agency and a vendor concerning the duties and responsibilities of the vendor and the State agency with respect to a vendor's participation in the WIC Program.</text> </paragraph> <paragraph num="(42)"> <text>“Vendor applicant” means a sole proprietorship, partnership, cooperative association, corporation, or other business entity operating one or more stores that has applied to the State agency for WIC authorization.</text> </paragraph> <paragraph num="(43)"> <text>“Vendor price list form” means the form used by the State agency to collect a vendor's shelf prices for WIC food items.</text> </paragraph> <paragraph num="(44)"> <text>“Vendor’s price” means the cost of a food package listed in Regulation .06A of this chapter as calculated from actual lowest shelf prices collected by the State agency during an on-site visit.</text> </paragraph> <paragraph num="(45)"> <text>“WIC” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) as authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended.</text> </paragraph> <paragraph num="(46)"> <text>“WIC-authorized foods list” means a list of foods authorized by the Maryland WIC program for purchase by Maryland WIC participants.</text> </paragraph> <paragraph num="(47)"> <text>“WIC Management Information System” means the WIC Program's software application, which provides:</text> <paragraph num="(a)"> <text>Client services;</text> </paragraph> <paragraph num="(b)"> <text>Financial management; and</text> </paragraph> <paragraph num="(c)"> <text>Vendor compliance oversight.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Authorization Requirements."> <paragraph num="A."> <text>A store shall obtain authorization to operate as a WIC vendor from the State agency before redeeming food benefits.</text> </paragraph> <paragraph num="B."> <text>A store:</text> <paragraph num="(1)"> <text>May not redeem WIC food benefits unless the store is authorized as a WIC vendor by the State agency;</text> </paragraph> <paragraph num="(2)"> <text>Constitutes a separate vendor and shall be authorized separately from other stores operated by the same business entity; and</text> </paragraph> <paragraph num="(3)"> <text>Shall have a single, fixed location.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In order to receive authorization from the State agency, a vendor shall:</text> <paragraph num="(1)"> <text>Submit a completed vendor application package as set forth in Regulation .07 of this chapter to the State agency;</text> </paragraph> <paragraph num="(2)"> <text>Have in its store from the time of application the minimum required stock as set forth in Regulation .14 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Post shelf prices for all WIC-approved foods at, on, or near the food items;</text> </paragraph> <paragraph num="(4)"> <text>Comply with applicable federal and State laws and regulations;</text> </paragraph> <paragraph num="(5)"> <text>Maintain the store premises in a sanitary condition with no evidence of:</text> <paragraph num="(a)"> <text>Excess trash;</text> </paragraph> <paragraph num="(b)"> <text>Vermin; or</text> </paragraph> <paragraph num="(c)"> <text>General lack of cleanliness;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Be accessible to persons with disabilities;</text> </paragraph> <paragraph num="(7)"> <text>Successfully complete an on-site review as set forth in Regulation .08 of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>Have a management representative attend a training session offered by the State agency;</text> </paragraph> <paragraph num="(9)"> <text>Be authorized by SNAP; and</text> </paragraph> <paragraph num="(10)"> <text>Be in good standing with SNAP and have not:</text> <paragraph num="(a)"> <text>Been disqualified;</text> </paragraph> <paragraph num="(b)"> <text>Been suspended;</text> </paragraph> <paragraph num="(c)"> <text>Been issued a charge or adverse action letter;</text> </paragraph> <paragraph num="(d)"> <text>Filed an appeal; or</text> </paragraph> <paragraph num="(e)"> <text>Been assessed a civil money penalty within the 24 months prior to the date of application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In order to receive authorization from the State agency, a vendor applicant may not:</text> <paragraph num="(1)"> <text>Have owners, officers, or managers that have been indicted for, convicted of, or have had a civil judgment entered against them for any activity indicating a lack of business integrity;</text> </paragraph> <paragraph num="(2)"> <text>Currently be under disqualification by the State agency;</text> </paragraph> <paragraph num="(3)"> <text>Owe money to the State agency; or</text> </paragraph> <paragraph num="(4)"> <text>Derive or derive after commencement of business more than 50 percent of the vendor’s or applicant’s annual eligible food sales revenue from food purchased with WIC food instruments, with the exception of:</text> <paragraph num="(a)"> <text>A nonprofit entity; or</text> </paragraph> <paragraph num="(b)"> <text>An above 50 percent vendor the State agency has authorized for participant access reasons.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Pursuant to Regulation .19 of this chapter, if the State agency determines that a participant hardship exists, where access to special infant formula and WIC-eligible medical foods are not available through a food/pharmacy combination store, the State agency, at its sole discretion, may authorize a pharmacy only vendor that shall:</text> <paragraph num="(1)"> <text>Adhere to the requirements set forth in §C(1) and (3)—(8) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Hold a current permit to operate as a pharmacy issued by the State Board of Pharmacy;</text> </paragraph> <paragraph num="(3)"> <text>Only accept WIC food instruments prescribing exempt infant formula and WIC-eligible medical foods; and</text> </paragraph> <paragraph num="(4)"> <text>Upon request by a participant, provide exempt infant formulas and WIC-eligible medical foods within 48 hours, excluding weekends and holidays.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Except for a pharmacy only or military commissary, a vendor applicant shall have actual lowest current shelf prices that are less than or equal to 125 percent of the peer group average in the vendor applicant’s region during the month of application, as determined by the State agency for each of the food packages set forth in Regulation .06A of this chapter.</text> </paragraph> <paragraph num="G."> <text>A vendor applicant may not apply for authorization in order to circumvent sanctions imposed by SNAP or the State agency on a previous vendor.</text> </paragraph> <paragraph num="H."> <text>The vendor applicant shall provide to the State agency documents that demonstrate the vendor applicant has submitted the application in good faith including but not limited to:</text> <paragraph num="(1)"> <text>A copy of the sales agreement including but not limited to the sales price;</text> </paragraph> <paragraph num="(2)"> <text>Names and addresses of the owners, directors, managers, and other decision makers of the store, including whether any of these people are related to the vendor who has been sanctioned; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the lease or deed for the store.</text> </paragraph> </paragraph> <paragraph num="I."> <text>In order to determine whether the vendor applicant seeks authorization in order to circumvent sanctions imposed on a vendor by the State agency, the State agency shall review the totality of the circumstances and may consider whether the:</text> <paragraph num="(1)"> <text>Vendor applicant is related to the former vendor;</text> </paragraph> <paragraph num="(2)"> <text>Former vendor or a relative of the former vendor is involved in the operation of the store;</text> </paragraph> <paragraph num="(3)"> <text>Former vendor or a relative of the former vendor is a director, officer, or otherwise part of the entity that will own the store; and</text> </paragraph> <paragraph num="(4)"> <text>Business was sold for fair market value.</text> </paragraph> </paragraph> <paragraph num="J."> <text>A store can be reassessed at any time during the authorization period to ensure that it meets the current vendor authorization requirements as set forth in this regulation.</text> </paragraph> <paragraph num="K."> <text>A vendor applicant denied authorization three times in a 12-month period may not reapply until after 12 months have passed since the last denial date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for Military Commissaries."> <paragraph num="A."> <text>The State agency shall authorize a military commissary vendor applicant that complies with the requirements of §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>To become an authorized WIC vendor, a military commissary shall complete and sign a vendor agreement based on the memorandum of understanding jointly prepared by the USDA and the United States Department of Defense, in place of the vendor agreement defined in Regulation .03B of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Food Packages for Peer Group Price Calculation."> <paragraph num="A."> <text>The State agency shall group the food items on the vendor price list form into the following food packages:</text> <paragraph num="(1)"> <text>Foods for an infant 4 months old or older but younger than 13 months old:</text> <paragraph num="(a)"> <text>31 13-fluid-ounce cans of concentrated liquid infant formula with iron as specified in the WIC infant formula rebate contract;</text> </paragraph> <paragraph num="(b)"> <text>24 ounces of dry infant cereal; and</text> </paragraph> <paragraph num="(c)"> <text>128 ounces of infant vegetables and fruit;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Foods for a child 1 year old or older but younger than 5 years old:</text> <paragraph num="(a)"> <text>3 gallons and 1 quart of fluid milk;</text> </paragraph> <paragraph num="(b)"> <text>1 dozen large eggs;</text> </paragraph> <paragraph num="(c)"> <text>36 ounces of dry cereal;</text> </paragraph> <paragraph num="(d)"> <text>128 fluid ounces of single-strength canned juice;</text> </paragraph> <paragraph num="(e)"> <text>18 ounces of peanut butter;</text> </paragraph> <paragraph num="(f)"> <text>1 pound of cheese; and</text> </paragraph> <paragraph num="(g)"> <text>2 pounds of whole wheat bread, brown rice, or soft corn tortillas;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Foods for a breastfeeding woman:</text> <paragraph num="(a)"> <text>5 gallons and 1 quart of fluid milk;</text> </paragraph> <paragraph num="(b)"> <text>2 dozen large eggs;</text> </paragraph> <paragraph num="(c)"> <text>36 ounces of dry cereal;</text> </paragraph> <paragraph num="(d)"> <text>36 ounces frozen juice concentrate;</text> </paragraph> <paragraph num="(e)"> <text>18 ounces of peanut butter;</text> </paragraph> <paragraph num="(f)"> <text>2 pounds of cheese;</text> </paragraph> <paragraph num="(g)"> <text>30 ounces of tuna, salmon, or sardines; and</text> </paragraph> <paragraph num="(h)"> <text>16 ounces of dried beans; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Foods for a nonbreastfeeding, postpartum woman:</text> <paragraph num="(a)"> <text>3 gallons and 1 quart of fluid milk;</text> </paragraph> <paragraph num="(b)"> <text>1 dozen large eggs;</text> </paragraph> <paragraph num="(c)"> <text>36 ounces of dry cereal;</text> </paragraph> <paragraph num="(d)"> <text>24 fluid ounces of single-strength frozen juice concentrate; and</text> </paragraph> <paragraph num="(e)"> <text>1 pound of cheese.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The State agency shall calculate monthly the peer group average in Peer Groups 1—18 for each food package set forth in §A of this regulation by adding together the average food instrument price and average cost of food items that make up a food package and dividing that sum by the total number of food store and food store/pharmacy combination vendors in the region.</text> </paragraph> <paragraph num="C."> <text>The State agency shall provide, upon request, the current peer group average in Peer Groups 1—19 for each food package in §A of this regulation.</text> </paragraph> <paragraph num="D."> <text>The State agency shall compile the peer group averages for the food packages in §A of this regulation based upon redemption data provided by the WIC Management Information System.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Vendor Application Package and Dates."> <paragraph num="A."> <text>The State agency shall provide an application package to a vendor that requests it.</text> </paragraph> <paragraph num="B."> <text>The application package shall consist of the following:</text> <paragraph num="(1)"> <text>An overview of the WIC Program;</text> </paragraph> <paragraph num="(2)"> <text>The minimum requirements for authorization;</text> </paragraph> <paragraph num="(3)"> <text>The WIC Authorized Foods List;</text> </paragraph> <paragraph num="(4)"> <text>The Minimum Required Stock List;</text> </paragraph> <paragraph num="(5)"> <text>The Application Checklist;</text> </paragraph> <paragraph num="(6)"> <text>The eWIC Readiness Assessment;</text> </paragraph> <paragraph num="(7)"> <text>The Vendor Application Price List;</text> </paragraph> <paragraph num="(8)"> <text>The Authorized Infant Formula and Medical Foods Supplier Directory;</text> </paragraph> <paragraph num="(9)"> <text>Instructions for completing the application for vendor authorization;</text> </paragraph> <paragraph num="(10)"> <text>An application for vendor authorization; and</text> </paragraph> <paragraph num="(11)"> <text>Two vendor agreements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="On-Site Review of Vendor Applicants."> <paragraph num="A."> <text>A military commissary is exempt from State on-site reviews.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §A of this regulation, the State agency shall conduct an unscheduled on-site review of a vendor applicant’s store within 60 days of receipt of an application to ensure that the store meets the requirements for authorization as set forth in Regulation .04C(1)—(6) and .04D of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Grant, Retention, and Denial of Authorization."> <paragraph num="A."> <text>The State agency shall grant or deny authorization to a vendor applicant within 60 days of receipt of an application.</text> </paragraph> <paragraph num="B."> <text>Authorization Granted. The State agency shall grant authorization if the vendor applicant's store meets the requirements for authorization as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Authorization Retained. A vendor retains its authorization until the:</text> <paragraph num="(1)"> <text>Vendor’s authorization is terminated as a sanction for a Program violation in accordance with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>State agency terminates the vendor's authorization in accordance with the provisions of the vendor agreement;</text> </paragraph> <paragraph num="(3)"> <text>Vendor notifies the State agency it wishes to cease operation as a WIC vendor;</text> </paragraph> <paragraph num="(4)"> <text>Authorization period as contained in the vendor agreement has expired; or</text> </paragraph> <paragraph num="(5)"> <text>Vendor is determined, in accordance with Regulation .10H of this chapter, to derive more than 50 percent of its eligible food sales from the redemption of WIC food benefits.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Authorization Denied.</text> <paragraph num="(1)"> <text>The State agency shall deny authorization if a vendor applicant's store does not meet the minimum requirements for authorization as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Upon denial of an application, the State agency shall notify a vendor applicant:</text> <paragraph num="(a)"> <text>In writing of the reason for denial of its application; and</text> </paragraph> <paragraph num="(b)"> <text>Of its right to request a hearing on the denial as set forth in Regulation .18 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Authorization Period.</text> <paragraph num="(1)"> <text>The State agency, in accordance with 7 CFR 246.12, may not authorize a vendor for a period exceeding 3 years.</text> </paragraph> <paragraph num="(2)"> <text>The State Agency, at its discretion, may authorize a vendor for a period less than 3 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09-1" heading="Price Determinations."> <paragraph num="A."> <text>The WIC Program shall calculate peer group averages according to the peer groups set forth in Regulation .03B(33)—(38) of this chapter.</text> </paragraph> <paragraph num="B."> <text>The WIC Program may implement price determinations that are applicable statewide, or to specific peer groups, provided that vendors receive 30 days notice of the intended determination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Food Package Prices After Authorization."> <paragraph num="A."> <text>After authorization, a vendor, other than a pharmacy only or military commissary, shall maintain prices for each of the food packages set forth in Regulation .06A of this chapter that are less than or equal to 125 percent of the peer group average for each food package.</text> </paragraph> <paragraph num="B."> <text>Upon request of the State agency, a vendor, other than a pharmacy or military commissary, shall submit on the vendor price list form its lowest shelf prices for WIC-authorized foods to the State agency.</text> </paragraph> <paragraph num="C."> <text>The State agency shall notify a vendor, other than a pharmacy only or a military commissary, that fails to submit its prices on the vendor price list form when requested to do so that, if the price list form is not received by the Program within 10 business days of the State agency’s request, the vendor’s authorization shall be terminated for 12 months from the date of disqualification.</text> </paragraph> <paragraph num="D."> <text>If a vendor, other than a military commissary, submits prices on the vendor price list form that make its food package price more than 125 percent of the peer group average for that food package, or the food package prices are determined by the WIC Management Information System calculation to exceed 125 percent of the peer group average, the State agency shall notify the vendor that:</text> <paragraph num="(1)"> <text>Its price submission or food package price calculation is unacceptable;</text> </paragraph> <paragraph num="(2)"> <text>It shall lower its actual lowest shelf prices for the WIC foods and resubmit the vendor price list form to the State agency within 10 days following the notification; and</text> </paragraph> <paragraph num="(3)"> <text>If the vendor’s resubmitted prices indicate that a food package will cost the Program more than 125 percent of the peer group average for that food package, the State agency may disqualify the vendor for 12 months from the date of disqualification.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If, at any time, a vendor, other than a military commissary, has actual lowest shelf prices that make any food package price more than 125 percent of the peer group average, the State agency shall notify the vendor that:</text> <paragraph num="(1)"> <text>The vendor shall lower its actual lowest shelf prices for the WIC foods within 10 days; and</text> </paragraph> <paragraph num="(2)"> <text>If the vendor’s prices remain so that a food package will cost the Program more than 125 percent of the peer group average, the vendor’s authorization shall be terminated for 12 months from the date of disqualification.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If, in 2 consecutive reporting months, a vendor, other than a pharmacy only or a military commissary, is determined by the WIC Management Information System calculation to have food package prices that exceed 125 percent of the peer group average, the vendor’s authorization shall be terminated for 12 months from the date of disqualification.</text> </paragraph> <paragraph num="G."> <text>The State agency may request that a vendor, other than a pharmacy only or a military commissary, submit semi-annual price lists at the State agency’s sole discretion and may use these price lists and the WIC Management Information System for calculation of excess charges if it is determined that excess charges have occurred.</text> </paragraph> <paragraph num="H."> <text>For the purpose of cost containment, the State agency shall assign to an above 50 percent vendor peer group a vendor that is determined by the State agency, through a comparison of the vendor's gross annual sales, SNAP eligible sales, and WIC redemptions, to derive more than 50 percent of the vendor's eligible food sales revenue from the redemption of WIC food instruments.</text> </paragraph> <paragraph num="I."> <text>A vendor that has been determined to derive more than 50 percent of its eligible food sales revenue from the redemption of WIC food instruments will only be paid at the statewide average of all other non-above 50 percent vendors.</text> </paragraph> <paragraph num="J."> <text>For the purpose of cost containment, the State agency:</text> <paragraph num="(1)"> <text>Shall use the methodology provided by the U.S. Department of Agriculture, Food Nutrition Service to ascertain whether or not the vendor derives more than 50 percent of the vendor’s eligible food sales revenue from the redemption of WIC food instruments; and</text> </paragraph> <paragraph num="(2)"> <text>May reject information submitted by a vendor to demonstrate that it does not derive more than 50 percent of the vendor’s eligible food sales revenue from the redemption of WIC food instruments.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Maximum Reimbursement to Vendors."> <paragraph num="A."> <text>Food Store, Food Store/Pharmacy Combination, and Pharmacy Only Vendors. The State agency shall establish a maximum price payable for each WIC-approved food item, which shall be calculated as follows:</text> <paragraph num="(1)"> <text>Based on the WIC Management Information System calculation, the State agency shall determine every month the peer group average for each WIC-approved food item; and</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C of this regulation, the maximum price payable for a food instrument prescribing infant formula shall be:</text> <paragraph num="(a)"> <text>Equal to 125 percent of the peer group averages as determined by the WIC Management Information System calculation for the individual food items on the food instrument; or</text> </paragraph> <paragraph num="(b)"> <text>Limited to an amount determined by the Program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Military Commissaries. The maximum price payable by the State agency for a food item redeemed by a military commissary is the price charged by the military commissary.</text> </paragraph> <paragraph num="C."> <text>The maximum price payable to vendors that are determined to derive more than 50 percent of their annual sales revenue from the redemption of WIC food benefits may not exceed the Statewide average price per food item paid to all other vendors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Recovery of Excess Charges."> <paragraph num="A."> <text>The State agency, through prepayment and post payment edit review of WIC redemptions, shall ensure that excess charges do not occur.</text> </paragraph> <paragraph num="B."> <text>If the State agency determines that excess charges have occurred as a result of software, bank, or other error, the State agency reserves the right to bill a vendor for excess charges.</text> </paragraph> <paragraph num="C."> <text>The State agency may not bill a vendor if the vendor's excess charges total $25 or less.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="WIC-Authorized Foods."> <paragraph num="A."> <text>The State agency shall:</text> <paragraph num="(1)"> <text>Maintain the WIC-authorized foods list;</text> </paragraph> <paragraph num="(2)"> <text>Make the list available to all participants and authorized WIC vendors; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain the APL.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A vendor shall keep a copy of the Program’s current WIC-authorized foods list:</text> <paragraph num="(1)"> <text>At each cash register where WIC transactions are handled; and</text> </paragraph> <paragraph num="(2)"> <text>On-site at the authorized vendor location along with the vendor manual.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The WIC-authorized foods list shall be used in conjunction with the APL to identify foods items that are eligible for purchase using WIC food instruments.</text> </paragraph> <paragraph num="D."> <text>Food instruments may require that program participants purchase specific manufacturers or brands that are not included in the WIC-authorized foods list.</text> </paragraph> <paragraph num="E."> <text>Authorized vendors shall sell WIC-approved brands for food categories identified in the WIC-authorized foods list and the APL.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Minimum Required Stock."> <paragraph num="A."> <text>A food store or food store/pharmacy combination vendor with four or more cash registers shall maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the following minimum required stock:</text> <paragraph num="(1)"> <text>Fluid milk:</text> <paragraph num="(a)"> <text>4 gallons whole; and</text> </paragraph> <paragraph num="(b)"> <text>6 gallons 1-percent or fat-free;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>6 dozen medium or large white or brown eggs;</text> </paragraph> <paragraph num="(3)"> <text>Domestic cheese:</text> <paragraph num="(a)"> <text>Four varieties;</text> </paragraph> <paragraph num="(b)"> <text>A total of 6 pounds;</text> </paragraph> <paragraph num="(c)"> <text>8 or 16-ounce packages only; and</text> </paragraph> <paragraph num="(d)"> <text>Block, shredded, stick, string, cubed, cracker cuts, or sliced;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Unsweetened 100-percent juice:</text> <paragraph num="(a)"> <text>Two varieties; and</text> </paragraph> <paragraph num="(b)"> <text>Six 64-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Frozen concentrate unsweetened 100-percent fruit juice:</text> <paragraph num="(a)"> <text>Two varieties; and</text> </paragraph> <paragraph num="(b)"> <text>Six 11.5—12-ounce cans or 48-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>32 total infant fruits and vegetables:</text> <paragraph num="(a)"> <text>Two varieties of each;</text> </paragraph> <paragraph num="(b)"> <text>16 4-ounce containers of each; and</text> </paragraph> <paragraph num="(c)"> <text>Plain, a combination of fruits, a combination of vegetables, or a combination of fruits and vegetables;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Infant meats:</text> <paragraph num="(a)"> <text>Six 2.5-ounce jars; and</text> </paragraph> <paragraph num="(b)"> <text>One variety of plain meat;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Dry cereal:</text> <paragraph num="(a)"> <text>Corn, wheat, oats, or rice:</text> <paragraph num="(i)"> <text>Six 12-ounce or larger containers; and</text> </paragraph> <paragraph num="(ii)"> <text>Two varieties;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Whole grain wheat or oats:</text> <paragraph num="(i)"> <text>Six 12-ounce or larger containers; and</text> </paragraph> <paragraph num="(ii)"> <text>Two varieties; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>At least one hot cereal in an 11.8-ounce container or larger;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Infant cereal:</text> <paragraph num="(a)"> <text>Six 8-ounce or 16-ounce containers dry;</text> </paragraph> <paragraph num="(b)"> <text>Two varieties; and</text> </paragraph> <paragraph num="(c)"> <text>At least one variety of rice;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Peanut butter:</text> <paragraph num="(a)"> <text>One brand; and</text> </paragraph> <paragraph num="(b)"> <text>Six 16—18-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Beans:</text> <paragraph num="(a)"> <text>Three 1-pound bags dry type in two varieties; and</text> </paragraph> <paragraph num="(b)"> <text>12 15—16-ounce packed in water cans in three varieties;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>Canned fish:</text> <paragraph num="(a)"> <text>30-ounces total and packed in water; and</text> </paragraph> <paragraph num="(b)"> <text>Two varieties of:</text> <paragraph num="(i)"> <text>Canned chunk light tuna in 5—6-ounce cans;</text> </paragraph> <paragraph num="(ii)"> <text>Pink salmon in 5—7.5-ounce or 14.75-ounce cans; and</text> </paragraph> <paragraph num="(iii)"> <text>Sardines in 3.75-ounce cans;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>Fruits and vegetables:</text> <paragraph num="(a)"> <text>A total value of $32;</text> </paragraph> <paragraph num="(b)"> <text>Two varieties of fruits, fresh, whole or cut, loose or prepackaged, frozen or canned; and</text> </paragraph> <paragraph num="(c)"> <text>Two varieties of vegetables, fresh, whole or cut, loose or prepackaged, frozen or canned;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Bread, rolls, tortillas, pasta, rice, and oats in two varieties and a total of 4 pounds:</text> <paragraph num="(a)"> <text>100 percent whole grain or whole wheat bread, 16-ounce packages;</text> </paragraph> <paragraph num="(b)"> <text>100 percent whole grain or whole wheat rolls, 15—16-ounce packages;</text> </paragraph> <paragraph num="(c)"> <text>Dry, plain brown rice, 16-ounce packages;</text> </paragraph> <paragraph num="(d)"> <text>Soft corn or whole wheat tortillas, 16-ounce packages;</text> </paragraph> <paragraph num="(e)"> <text>Whole grain or whole wheat pasta, 16-ounce packages; or</text> </paragraph> <paragraph num="(f)"> <text>100-percent oats, 16-ounce packages; and</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Infant formula:</text> <paragraph num="(a)"> <text>15 12.4-ounce containers, or containers of the currently authorized size, of powdered infant formula as specified by the WIC infant formula rebate contract; and</text> </paragraph> <paragraph num="(b)"> <text>Four 12.4-ounce containers, or containers of the currently authorized size, of soy-based powdered infant formula as specified by the WIC infant formula rebate contract.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A food store or food store/pharmacy combination vendor with one to three cash registers shall maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the following minimum required stock:</text> <paragraph num="(1)"> <text>Fluid milk:</text> <paragraph num="(a)"> <text>2 gallons whole; and</text> </paragraph> <paragraph num="(b)"> <text>3 gallons 1-percent or fat-free;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>6 dozen medium or large white or brown eggs;</text> </paragraph> <paragraph num="(3)"> <text>Domestic cheese:</text> <paragraph num="(a)"> <text>Two varieties;</text> </paragraph> <paragraph num="(b)"> <text>A total of 3 pounds;</text> </paragraph> <paragraph num="(c)"> <text>8 or 16-ounce packages only; and</text> </paragraph> <paragraph num="(d)"> <text>Block, shredded, stick, string, cubed, cracker cuts, or sliced;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Unsweetened 100-percent fruit juice:</text> <paragraph num="(a)"> <text>Two varieties; and</text> </paragraph> <paragraph num="(b)"> <text>Three 64-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Frozen concentrate unsweetened 100-percent juice:</text> <paragraph num="(a)"> <text>One variety; and</text> </paragraph> <paragraph num="(b)"> <text>Three 11.5—12-ounce cans or three 48-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>20 total infant fruits and vegetables:</text> <paragraph num="(a)"> <text>Two varieties of each;</text> </paragraph> <paragraph num="(b)"> <text>10 4-ounce containers of each; and</text> </paragraph> <paragraph num="(c)"> <text>Plain, a combination of fruits, a combination of vegetables, or a combination of fruits and vegetables;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Dry cereal:</text> <paragraph num="(a)"> <text>Corn, wheat, oats, or rice:</text> <paragraph num="(i)"> <text>Three 12-ounce or larger containers; and</text> </paragraph> <paragraph num="(ii)"> <text>One variety;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Whole grain wheat or oats:</text> <paragraph num="(i)"> <text>Three 12-ounce or larger containers; and</text> </paragraph> <paragraph num="(ii)"> <text>One variety;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>Infant cereal:</text> <paragraph num="(a)"> <text>Three 8-ounce or 16-ounce containers dry; and</text> </paragraph> <paragraph num="(b)"> <text>One variety;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Peanut butter:</text> <paragraph num="(a)"> <text>One brand; and</text> </paragraph> <paragraph num="(b)"> <text>Three 16—18-ounce containers;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Beans. Two varieties of five 15—16-ounce cans packed in water;</text> </paragraph> <paragraph num="(11)"> <text>Canned fish:</text> <paragraph num="(a)"> <text>15 ounces total and packed in water; and</text> </paragraph> <paragraph num="(b)"> <text>One variety of:</text> <paragraph num="(i)"> <text>Canned chunk light tuna in 5—6-ounce cans;</text> </paragraph> <paragraph num="(ii)"> <text>Pink salmon in 5—7.5-ounce or 14.75-ounce cans; and</text> </paragraph> <paragraph num="(iii)"> <text>Sardines in 3.75-ounce cans;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>Fruits and vegetables:</text> <paragraph num="(a)"> <text>A total value of $16;</text> </paragraph> <paragraph num="(b)"> <text>One variety of fruits, fresh, whole or cut, loose or prepackaged, frozen or canned; and</text> </paragraph> <paragraph num="(c)"> <text>One variety of vegetables, fresh, whole or cut, loose or prepackaged, frozen or canned;</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>Bread, rolls, tortillas, pasta, rice and oats in two varieties and a total of two pounds:</text> <paragraph num="(a)"> <text>100-percent whole grain or whole wheat bread, 16-ounce packages;</text> </paragraph> <paragraph num="(b)"> <text>100-percent whole grain or whole wheat rolls, 15—16-ounce packages;</text> </paragraph> <paragraph num="(c)"> <text>Dry, plain brown rice, 16-ounce packages;</text> </paragraph> <paragraph num="(d)"> <text>Soft corn or whole wheat tortillas, 16-ounce packages;</text> </paragraph> <paragraph num="(e)"> <text>Whole grain or whole wheat pasta, 16-ounce packages; or</text> </paragraph> <paragraph num="(f)"> <text>100-percent oats, 16-ounce packages; and</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Infant Formula. Seven 12.4-ounce containers, or containers of the currently authorized size, of powdered infant formula as specified by the WIC infant formula rebate contract.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A pharmacy only or food store/pharmacy combination vendor shall provide exempt formulas, or WIC-eligible medical foods within 48 hours, excluding weekends and holidays, for a request by a participant or the Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Required Vendor Practices."> <paragraph num="A."> <text>The State agency or its representative shall conduct inventory audits, compliance buys, and monitoring to ensure that authorized vendors comply with required vendor practices.</text> </paragraph> <paragraph num="B."> <text>General Requirements.</text> <paragraph num="(1)"> <text>A vendor shall:</text> <paragraph num="(a)"> <text>Maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the minimum required stock;</text> </paragraph> <paragraph num="(b)"> <text>Post the State agency’s WIC sign at the front of the store or in a conspicuous place on the store premises and use other materials provided or approved by the WIC program;</text> </paragraph> <paragraph num="(c)"> <text>Maintain the vendor premises in a sanitary condition with no evidence of:</text> <paragraph num="(i)"> <text>Excess trash;</text> </paragraph> <paragraph num="(ii)"> <text>Vermin; or</text> </paragraph> <paragraph num="(iii)"> <text>General lack of cleanliness;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Display a current food service facility license, issued by the local health department or department of environment, or if a pharmacy only or a food store/pharmacy combination, a pharmacy permit issued by the State Board of Pharmacy, in a location visible to Program representatives;</text> </paragraph> <paragraph num="(e)"> <text>Train vendor personnel in WIC policies and procedures;</text> </paragraph> <paragraph num="(f)"> <text>Display the shelf price of a WIC food at, on, or near the item;</text> </paragraph> <paragraph num="(g)"> <text>Treat individuals redeeming food instruments the same as other customers;</text> </paragraph> <paragraph num="(h)"> <text>Submit information requested by the State agency by the date requested;</text> </paragraph> <paragraph num="(i)"> <text>Attend a WIC training that has been required by the Program for a vendor with a high rate of:</text> <paragraph num="(i)"> <text>Errors;</text> </paragraph> <paragraph num="(ii)"> <text>Rejected transactions;</text> </paragraph> <paragraph num="(iii)"> <text>Complaints; or</text> </paragraph> <paragraph num="(iv)"> <text>Other minor violations;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Provide WIC foods in a store at a fixed location;</text> </paragraph> <paragraph num="(k)"> <text>If a pharmacy only or a food store/pharmacy combination:</text> <paragraph num="(i)"> <text>Upon request by a participant or the Program, provide infant formulas and medical foods within 48 hours, excluding weekends and holidays;</text> </paragraph> <paragraph num="(ii)"> <text>Only accept the food instrument after obtaining the requested formula; and</text> </paragraph> <paragraph num="(iii)"> <text>If a pharmacy only vendor, only accept food instruments prescribing infant formula and WIC-eligible medical foods;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Maintain accounting records that are relevant to the vendor’s performance under the vendor agreement for 3 years, for review at reasonable times by State agency representatives or other authorized State or federal officials;</text> </paragraph> <paragraph num="(m)"> <text>If a SNAP vendor, remain in good standing and not:</text> <paragraph num="(i)"> <text>Be disqualified;</text> </paragraph> <paragraph num="(ii)"> <text>Be suspended;</text> </paragraph> <paragraph num="(iii)"> <text>Have been issued a charge or adverse action letter;</text> </paragraph> <paragraph num="(iv)"> <text>Have filed an appeal; or</text> </paragraph> <paragraph num="(v)"> <text>Have been assessed a civil money penalty;</text> </paragraph> </paragraph> <paragraph num="(n)"> <text>Give 30 days notice to the State agency of the store's closing, relocation, or change in ownership;</text> </paragraph> <paragraph num="(o)"> <text>Pay, by the date due, money penalties imposed by the State agency and overcharges;</text> </paragraph> <paragraph num="(p)"> <text>Submit the vendor price list form when requested to do so by the State agency;</text> </paragraph> <paragraph num="(q)"> <text>For the food packages set forth in Regulation .06A of this chapter, maintain prices that are less than or equal to 125 percent of the peer group average as determined by the WIC Management Information System calculation for each food package;</text> </paragraph> <paragraph num="(r)"> <text>Have a representative attend and participate in an annual vendor training session once every 12 months, if the State agency:</text> <paragraph num="(i)"> <text>Gives the vendor 14 days notice of a scheduled training session; and</text> </paragraph> <paragraph num="(ii)"> <text>Holds the training session in the vendor’s region or offers the training session virtually;</text> </paragraph> </paragraph> <paragraph num="(s)"> <text>If more than 30 days are needed to reopen the vendor’s business in the same location, reapply for authorization and be approved as a WIC vendor in order to obtain authorization to operate as a WIC Vendor; and</text> </paragraph> <paragraph num="(t)"> <text>Maintain an active email account that is monitored no less than once a week.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A vendor may not:</text> <paragraph num="(a)"> <text>Charge WIC participants a higher price for food than other customers;</text> </paragraph> <paragraph num="(b)"> <text>Violate the nondiscrimination provisions of federal regulations in 7 CFR 15, 15a, and 15b, as incorporated by reference in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Provide false information to the Program;</text> </paragraph> <paragraph num="(d)"> <text>Except for a pharmacy or military commissary, process fewer than 25 WIC transactions in a consecutive 3-month period;</text> </paragraph> <paragraph num="(e)"> <text>Intentionally submit false prices on the vendor price list form;</text> </paragraph> <paragraph num="(f)"> <text>Use the WIC acronym or WIC logo, or close facsimiles, in the name of the vendor or in advertising or other promotional materials;</text> </paragraph> <paragraph num="(g)"> <text>Apply stickers, tags, or labels that have the WIC acronym or logo on WIC-approved foods;</text> </paragraph> <paragraph num="(h)"> <text>Use manufacturer supplied shelf tags, talkers, or labels that make unauthorized use of the WIC acronym or logo;</text> </paragraph> <paragraph num="(i)"> <text>Apply WIC-approved shelf tags to nonapproved foods; or</text> </paragraph> <paragraph num="(j)"> <text>Derive more than 50 percent of its annual SNAP eligible foods sales from WIC food benefits.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Accounting Records. Accounting records shall include, but are not limited to:</text> <paragraph num="(a)"> <text>Sales and use tax returns;</text> </paragraph> <paragraph num="(b)"> <text>U.S. individual or business tax returns;</text> </paragraph> <paragraph num="(c)"> <text>Daily sales journals or daily ledgers;</text> </paragraph> <paragraph num="(d)"> <text>Sales receipts or register tape;</text> </paragraph> <paragraph num="(e)"> <text>Inventory invoices; and</text> </paragraph> <paragraph num="(f)"> <text>A breakdown of sales between SNAP eligible foods and non-eligible foods.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Inventory Invoices.</text> <paragraph num="(a)"> <text>Inventory invoices shall include the:</text> <paragraph num="(i)"> <text>Name and address of the supplier;</text> </paragraph> <paragraph num="(ii)"> <text>Date of purchase;</text> </paragraph> <paragraph num="(iii)"> <text>Description of the exact food items purchased, including size, stock number, and UPC code if available;</text> </paragraph> <paragraph num="(iv)"> <text>Unit price of the food items;</text> </paragraph> <paragraph num="(v)"> <text>Total quantity purchased; and</text> </paragraph> <paragraph num="(vi)"> <text>If inventory invoices do not completely describe the actual food item, verifiable computer codes for the item.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Inventory invoices or purchase receipts for infant formula shall only be accepted from those wholesalers, distributors, and manufacturers listed on Maryland’s Authorized Infant Formula and Medical Foods Supplier Directory.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A vendor who violates the provisions set forth in this section is subject to the sanctions in Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Transactional Requirements.</text> <paragraph num="(1)"> <text>A vendor shall:</text> <paragraph num="(a)"> <text>Provide authorized foods to an individual redeeming food benefits only upon presentation of a valid food instrument;</text> </paragraph> <paragraph num="(b)"> <text>Accept the WIC food instrument with a valid PIN as identification without requiring another form of identification;</text> </paragraph> <paragraph num="(c)"> <text>At the time of purchase, give a participant a receipt indicating the store name, date of transaction, and total dollar amount for items purchased with a food instrument and that the sale was a WIC transaction;</text> </paragraph> <paragraph num="(d)"> <text>Provide the WIC participant with a shopping list of remaining benefits upon request;</text> </paragraph> <paragraph num="(e)"> <text>Accept a food instrument only for authorized food brands, quantities, and types and as prescribed on the food instrument;</text> </paragraph> <paragraph num="(f)"> <text>Accept cents-off coupons from an individual redeeming WIC food instruments for prescribed approved foods and deduct savings from the purchase price;</text> </paragraph> <paragraph num="(g)"> <text>Allow the use of bonus or club cards, buy one, get one free, and any other promotion offered to store customers that does not involve cash back;</text> </paragraph> <paragraph num="(h)"> <text>Accept a valid food instrument as payment in full for the prescribed WIC foods purchased;</text> </paragraph> <paragraph num="(i)"> <text>Allow participants and proxies authorized to redeem food benefits a choice of the WIC-approved foods in the participant’s benefits balance;</text> </paragraph> <paragraph num="(j)"> <text>Allow the purchase of the full amount or less than the full amount of food on a food instrument;</text> </paragraph> <paragraph num="(k)"> <text>Redeem valid food instruments presented by a participant or proxy;</text> </paragraph> <paragraph num="(l)"> <text>Scan the actual UPC code that is affixed to the item being purchased by the WIC participant;</text> </paragraph> <paragraph num="(m)"> <text>Allow the participant to pay the difference when a fruit and vegetable purchase exceeds the value of the cash value benefit; and</text> </paragraph> <paragraph num="(n)"> <text>Obtain infant formula only from manufacturers, distributors, and wholesalers listed on Maryland’s Authorized Infant Formula and Medical Foods Supplier Directory, as available on the Program’s website.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A vendor may not:</text> <paragraph num="(a)"> <text>Ask a participant or proxy for the PIN securing their food instrument;</text> </paragraph> <paragraph num="(b)"> <text>Redeem food benefits for spoiled or out-of-date food;</text> </paragraph> <paragraph num="(c)"> <text>Redeem food benefits in whole or in part for a non-food item or credit;</text> </paragraph> <paragraph num="(d)"> <text>Issue a rain check that would allow an individual redeeming a food benefit to get, at a later date, an item the vendor does not have at the time the food instrument is presented;</text> </paragraph> <paragraph num="(e)"> <text>Transfer cash in the form of change from the food benefit to an individual redeeming a food instrument;</text> </paragraph> <paragraph num="(f)"> <text>Collect sales tax on WIC food purchases;</text> </paragraph> <paragraph num="(g)"> <text>Traffic in WIC food instruments or benefits;</text> </paragraph> <paragraph num="(h)"> <text>Sell alcohol, alcoholic beverages, or tobacco products in exchange for a food instrument or benefits;</text> </paragraph> <paragraph num="(i)"> <text>Accept a food instrument or benefits in exchange for:</text> <paragraph num="(i)"> <text>Ammunition;</text> </paragraph> <paragraph num="(ii)"> <text>A firearm;</text> </paragraph> <paragraph num="(iii)"> <text>An explosive; or</text> </paragraph> <paragraph num="(iv)"> <text>A controlled substance as defined by 21 U.S.C. §802;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Manually key in a food instrument number without an actual food instrument being presented; or</text> </paragraph> <paragraph num="(k)"> <text>Scan UPC codes from:</text> <paragraph num="(i)"> <text>Codebooks;</text> </paragraph> <paragraph num="(ii)"> <text>Reference sheets; or</text> </paragraph> <paragraph num="(iii)"> <text>Lists.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>A vendor may not provide solely to participants incentive items or other free merchandise, including food.</text> </paragraph> <paragraph num="(4)"> <text>A vendor who violates the provisions of this section is subject to the sanctions in Regulation .16 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Post-Transactional Requirements.</text> <paragraph num="(1)"> <text>A vendor shall:</text> <paragraph num="(a)"> <text>Notify the Program of attempted or actual misuse of WIC food instruments by a participant or other individual;</text> </paragraph> <paragraph num="(b)"> <text>Receive reimbursement only for approved benefits redeemed at the vendor’s store;</text> </paragraph> <paragraph num="(c)"> <text>Charge the State agency only for approved food received by a participant;</text> </paragraph> <paragraph num="(d)"> <text>Reimburse the Program for the loss sustained by the Program due to theft, fraud, or improper handling of food instruments by vendor personnel or agents; and</text> </paragraph> <paragraph num="(e)"> <text>Surrender lost or stolen food instruments to WIC representatives upon request.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A vendor may not:</text> <paragraph num="(a)"> <text>Permit the return of food purchased with a food instrument in exchange for cash or another item;</text> </paragraph> <paragraph num="(b)"> <text>Claim reimbursement for the sale of an amount of a specific food item that exceeds the vendor’s documented inventory of that item for a specific period of time; or</text> </paragraph> <paragraph num="(c)"> <text>Claim reimbursement for vendor bank fees.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A vendor who violates the provisions of this section is subject to the sanctions in Regulation .16 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Vendor Sanctions."> <paragraph num="A."> <text>The Program may sanction a vendor that fails to comply with a required practice in Regulation .15B(1)(a)—(l), (n)—(q), and (t) and (2)(b) and (e)—(i), C(1)(a)—(n), (2)(a), (b), (d)—(f), (j), and (k), and (3), and D(1)(a) and (e) and (2)(a) and (c) of this chapter as follows:</text> <paragraph num="(1)"> <text>Written warning following each violation; and</text> </paragraph> <paragraph num="(2)"> <text>Disqualification for 1 year for a pattern of violations of the same provisions within a 12-month period.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(h) of this chapter by disqualifying the vendor for 3 years.</text> </paragraph> <paragraph num="C."> <text>The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(g) or(i) of this chapter by disqualifying the vendor for 6 years.</text> </paragraph> <paragraph num="D."> <text>The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(g) or(i) of this chapter by permanent disqualification if the vendor is convicted in a criminal court of charges stemming from those violations.</text> </paragraph> <paragraph num="E."> <text>The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15B(2)(a), C(2)(c) or (f), or D(1)(b) or (c) or (2)(b) of this chapter by:</text> <paragraph num="(1)"> <text>A written warning if one violation is detected in any 12-month period; or</text> </paragraph> <paragraph num="(2)"> <text>Disqualifying the vendor for 3 years for two or more violations of the same provision in any 12-month period.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When a vendor that has previously received a sanction for violation of the provisions of Regulation .15B(2)(a), C(2)(c) or (f), or D(1)(b) or (c) or (2)(b) of this chapter, the Program shall impose a 6-year disqualification for violation of the same provision.</text> </paragraph> <paragraph num="G."> <text>Disqualification.</text> <paragraph num="(1)"> <text>Except in circumstances described in §G(2) of this regulation, the Program shall disqualify a vendor that has been disqualified by SNAP in violation of Regulation .15B(1)(m) of this chapter for the same length of time as SNAP disqualification.</text> </paragraph> <paragraph num="(2)"> <text>If disqualification of the vendor will result in inadequate participant access in accordance with Regulation .19 of this chapter, the State agency shall impose a civil money penalty in lieu of disqualification.</text> </paragraph> <paragraph num="(3)"> <text>Except in circumstances described in §G(4) of this regulation, the Program shall disqualify a vendor that has been assessed a civil money penalty for hardship by SNAP instead of disqualification by SNAP in violation of Regulation .15B(1)(m) of this chapter, for the same period for which the vendor would otherwise have been disqualified by SNAP.</text> </paragraph> <paragraph num="(4)"> <text>If disqualification of a vendor that has been assessed a civil money penalty for hardship by SNAP instead of disqualification by SNAP would result in inadequate participant access in accordance with Regulation .19 of this chapter, the Department may not:</text> <paragraph num="(a)"> <text>Disqualify the vendor; or</text> </paragraph> <paragraph num="(b)"> <text>Impose a civil money penalty in lieu of disqualification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>The Program may not accept a vendor's voluntary cancellation of the vendor's authorization in lieu of a disqualification.</text> </paragraph> <paragraph num="I."> <text>The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15B(1)(r) or (s) or (2)(c), (d), or (j) or D(1)(d) of this chapter by terminating the vendor agreement.</text> </paragraph> <paragraph num="J."> <text>The State agency shall notify the USDA of a disqualification or money penalty:</text> <paragraph num="(1)"> <text>Within 15 days after the vendor's opportunity to request an administrative appeal has expired; or</text> </paragraph> <paragraph num="(2)"> <text>After the vendor's administrative appeals have been exhausted.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If a vendor is disqualified or has been assessed a money penalty because of multiple violations in a single investigation, the Program shall:</text> <paragraph num="(1)"> <text>Sanction the vendor for the single most serious violation; and</text> </paragraph> <paragraph num="(2)"> <text>Include the following in its notice to USDA:</text> <paragraph num="(a)"> <text>The vendor's:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address; and</text> </paragraph> <paragraph num="(iii)"> <text>Identification number;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The length of any disqualification;</text> </paragraph> <paragraph num="(c)"> <text>The specific violations charged; and</text> </paragraph> <paragraph num="(d)"> <text>The amount of any money penalty.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>Upon completion of the period of disqualification a vendor shall regain authorization after successfully completing the authorization process as set forth in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="M."> <text>Military Commissaries. The Program:</text> <paragraph num="(1)"> <text>May not sanction military commissaries for Program violations; and</text> </paragraph> <paragraph num="(2)"> <text>Shall report a sanctionable offense committed by a military commissary to the commanding officer of the installation and, if the commanding officer takes no action to ensure the violation does not recur, to the USDA.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Any adverse action taken by SNAP will be reciprocated by the Program to include disqualification and if applicable, imposing a civil money penalty.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Additional Penalties for Program Violations."> <text>In addition to the State agency sanctions set forth in Regulation .16 of this chapter, and pursuant to 7 CFR §§246.12(f)(xiv) and 246.23(d), a vendor that commits fraud and abuse of the Program may be liable to prosecution under federal, State, and local laws.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Vendor Appeals."> <paragraph num="A."> <text>Except as otherwise provided in this regulation, the procedures set forth in COMAR 10.01.03, and not the procedures set forth in COMAR 10.01.06, govern appeals by vendors and vendor applicants.</text> </paragraph> <paragraph num="B."> <text>Notice.</text> <paragraph num="(1)"> <text>Not less than 15 days in advance of the effective date of the proposed Program action, the Program shall provide notice to a vendor applicant, or vendor whose application is proposed to be denied or authorization is proposed to be disqualified, on the right to a hearing on the proposed denial or disqualification.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall provide notice that complies with the requirements set forth in COMAR 10.01.03.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Request for Hearing.</text> <paragraph num="(1)"> <text>A vendor or vendor applicant shall preserve the right to a hearing, if a hearing is desired, by filing a written request for a hearing with the Director of the Program within 10 days of the receipt of the notice of proposed disqualification or denial.</text> </paragraph> <paragraph num="(2)"> <text>The Program shall consider a request for a hearing filed on the earlier of the dates it is:</text> <paragraph num="(a)"> <text>Received by the Program; or</text> </paragraph> <paragraph num="(b)"> <text>Postmarked by the United States Postal Service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Hearings.</text> <paragraph num="(1)"> <text>The Office of Administrative Hearings shall have jurisdiction over the hearings provided in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>If a hearing is requested, the agency shall hold the hearing pursuant to:</text> <paragraph num="(a)"> <text>Health-General Article, §§18-107(a) and 18-108, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 10.01.03;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 28.02.01; and</text> </paragraph> <paragraph num="(e)"> <text>This chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A vendor may not appeal the following actions:</text> <paragraph num="(1)"> <text>Disqualification from WIC resulting from a violation of Regulation .15B(1)(m) of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>The State agency's decision as to whether a participant hardship exists;</text> </paragraph> <paragraph num="(3)"> <text>The expiration of a vendor agreement;</text> </paragraph> <paragraph num="(4)"> <text>The State agency's determination to include or exclude an infant formula manufacturer, wholesaler, distributor, or retailer from the required list of infant formula suppliers;</text> </paragraph> <paragraph num="(5)"> <text>The validity or appropriateness of the State agency’s prohibition of incentive items and the State agency’s denial of an above 50 percent vendor’s request to provide an incentive item;</text> </paragraph> <paragraph num="(6)"> <text>The State agency's determination whether to notify a vendor in writing when an investigation reveals an initial violation for which a pattern of violations must be established in order to impose a sanction;</text> </paragraph> <paragraph num="(7)"> <text>The validity or appropriateness of the State agency’s selection criteria for competitive price, including, but not limited to, vendor peer group criteria and the criteria used to identify vendors that are above 50 percent vendors or comparable to above 50 percent vendors;</text> </paragraph> <paragraph num="(8)"> <text>The State agency's determination whether a vendor had an effective policy and program in effect to prevent trafficking and that the ownership of the vendor was not aware of, did not approve of, and was not involved in the conduct of the violation;</text> </paragraph> <paragraph num="(9)"> <text>Disputes regarding payments and vendor claims, not including the opportunity to justify or correct a vendor overcharge or other error; or</text> </paragraph> <paragraph num="(10)"> <text>The validity or appropriateness of the State agency's vendor selection criteria.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Participant Hardship."> <paragraph num="A."> <text>Except for the sanction prescribed in Regulation .16D of this chapter, the State agency may determine that a participant hardship would exist if a vendor is disqualified and one of the following conditions would result:</text> <paragraph num="(1)"> <text>At least ten participants have to travel more than 2 miles to reach a vendor;</text> </paragraph> <paragraph num="(2)"> <text>A physical barrier or condition exists that would make normal travel to another vendor impossible; or</text> </paragraph> <paragraph num="(3)"> <text>Ten or more participants can only be served properly by a particular vendor because of a language barrier, religious dietary needs, access to exempt infant formula, or access to WIC-eligible medical foods.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the State agency determines that a participant hardship would exist if a vendor is disqualified, the State agency, in its sole discretion, may impose a money penalty instead of disqualification if the vendor:</text> <paragraph num="(1)"> <text>Provides to the State agency documentation that the violations that led to the sanction have been corrected; and</text> </paragraph> <paragraph num="(2)"> <text>Owes no payments to the State agency.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the State agency determines to impose a money penalty, the State agency shall calculate the amount of the money penalty for each violation by multiplying 10 percent of the vendor's average monthly food instrument redemptions by the number of months the disqualification would have been in effect.</text> </paragraph> <paragraph num="D."> <text>The State agency shall calculate the average monthly redemption by using:</text> <paragraph num="(1)"> <text>The 6 months immediately preceding notice to the vendor of the disqualification; or</text> </paragraph> <paragraph num="(2)"> <text>Up to 6 months' data if the vendor has not redeemed food instruments for a full 6 months before notice of the disqualification.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The maximum money penalty for each:</text> <paragraph num="(1)"> <text>Violation that would have resulted in a disqualification is $11,000; and</text> </paragraph> <paragraph num="(2)"> <text>Investigation that detected violations that would have resulted in disqualification is $49,000.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Vendor Money Payment.</text> <paragraph num="(1)"> <text>A vendor that owes a money penalty pursuant to §C of this regulation shall pay the money penalty either in a lump sum within 1 month from the date of billing by the State agency, or in installments.</text> </paragraph> <paragraph num="(2)"> <text>The State agency shall calculate the number of installment payments by dividing the amount due by 1/2 the number of months the disqualification would have been in effect.</text> </paragraph> <paragraph num="(3)"> <text>The vendor shall pay the:</text> <paragraph num="(a)"> <text>First installment not later than the date the disqualification would have been effective had there been no participant hardship; and</text> </paragraph> <paragraph num="(b)"> <text>Remaining payments on the first day of each succeeding month.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If a vendor fails to pay the money penalty in accordance with the payment schedule as provided in §F of this regulation, the State agency shall disqualify the vendor's authorization for the full period of the sanction and may not refund any partial payments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Conflict of Documents."> <text>If the provisions of this chapter conflict with the WIC State plan or other policies of the Program, the provisions of this chapter prevail.</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Conflict of Laws."> <text>If the provisions of this chapter conflict with federal statutes and regulations, including those incorporated by reference in Regulation .02 of this chapter, the federal statutes and regulations prevail.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 18-107(a), and 18-108, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.21 adopted as an emergency provision effective November 1, 1995 (22:22 Md. R. 1655 and 22:23 Md. R. 1796); emergency status expired May 1, 1996</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.21 adopted effective May 2, 1996 (23:6 Md. R. 476)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03, .04, .07, and .10—.16 amended as an emergency provision effective November 1, 1996 (23:24 Md. R. 1679); amended permanently effective February 24, 1997 (24:4 Md. R. 292)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended as an emergency provision effective July 1, 1998 (25:14 Md. R. 1128); amended permanently effective October 5, 1998 (25:20 Md. R. 1532)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 18, 2000 (27:18 Md. R. 1665)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.04, .06, .07, .09, .10—.13, .15, .16, .18, and .19 amended as an emergency provision effective October 1, 2002 (29:23 Md. R. 1807); amended permanently effective March 31, 2003 (30:6 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.04, .06, .07, .10, .11, and .14—.16 amended as an emergency provision effective December 15, 2006 (34:1 Md. R. 29); amended permanently effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B, .04C, F, .06, .10, .11, .13, .14A, .15, and .16G amended as an emergency provision effective December 22, 2004 (32:1 Md. R. 25); amended permanently effective March 14, 2005 (32:5 Md. R. 581)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03B, .04G, .09, .09-1, .10H, .11A, C, .13, .14A, and .15B, C amended as an emergency provision effective November 3, 2008 (35:24 Md. R. 2069); amended permanently effective February 9, 2009 (36:3 Md. R. 209)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, .09-1, .10, .13, .14A, .15B, C, .16A, B amended as an emergency provision effective October 5, 2011 (38:23 Md. R. 1416); amended permanently effective December 26, 2011 (38:26 Md. R. 1697)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulations .04, .09-1, .10, .11A, .13, .14A, .15B, C, .16, and .19E amended as an emergency provision effective October 1, 2012 (39:22 Md. R. 1427); amended permanently effective March 4, 2013 (40:4 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E, H amended effective April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulations .06A, .13, .14A, .15B, C, .16B, .18E, and .19E amended as an emergency provision effective September 16, 2009 (36:21 Md. R. 1587); amended permanently effective December 14, 2009 (36:25 Md. R. 1955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E adopted effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective March 13, 2017 (44:5 Md. R. 293)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09E adopted effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1 adopted as an emergency provision effective October 1, 2002 (29:23 Md. R. 1807); adopted permanently effective March 31, 2003 (30:6 Md. R. 421)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09-1A amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11A amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293);</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 repealed and new Regulation .12 adopted as an emergency provision effective December 22, 2004 (32:1 Md. R. 25); adopted permanently effective March 14, 2005 (32:5 Md. R. 581)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12A amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective May 12, 2014 (41:9 Md. R. 521); April 13, 2015 (42:7 Md. R. 570)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 repealed and new Regulation .13 adopted effective March 13, 2017 (44:5 Md. R. 293)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective March 13, 2017 (44:5 Md. R. 293); June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective May 12, 2014 (41:9 Md. R. 521); April 13, 2015 (42:7 Md. R. 570); October 5, 2020 (47:20 Md. October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective May 12, 2014 (41:9 Md. R. 521); June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18B, E amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18C, E amended effective March 13, 2017 (44:5 Md. R. 293)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18E amended effective October 5, 2020 (47:20 Md. R. 875)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective May 12, 2014 (41:9 Md. R. 521)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective March 13, 2017 (44:5 Md. R. 293); June 13, 2022 (49:12 Md. R. 640)</annotation> </annotations> </chapter> </subtitle> <subtitle num="55" heading="State Board of Spinal Cord Injury Research"> <chapter num="01" heading="Administration of Spinal Cord Injury Trust Fund" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: September 16, 2002 (29:18 Md. R. 1444)</annotation> <annotation type="History" subtype="Administrative History">Subtitle and Chapter repealed effective March 26, 2018 (45:6 Md. R. 321)</annotation> </annotations> </chapter> </subtitle> <subtitle num="56" heading="Board of Dietetic Practice"> <chapter num="01" heading="Licensure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>Except as provided in §B, of this regulation, these regulations apply to a person seeking to practice dietetics in the State.</text> </paragraph> <paragraph num="B."> <text>Exceptions. These regulations do not apply to a person who:</text> <paragraph num="(1)"> <text>Provides nonmedical nutrition services and information to the public while:</text> <paragraph num="(a)"> <text>Employed by or operating a health, weight loss, or fitness program,</text> </paragraph> <paragraph num="(b)"> <text>Employed by or operating a health food store,</text> </paragraph> <paragraph num="(c)"> <text>Employed by or operating a business that sells health products, including dietary supplements, foods, or food materials, or provides nonmedical nutritional information or distributes nutritional literature, or</text> </paragraph> <paragraph num="(d)"> <text>Conducting classes or disseminating information relative to nonmedical nutrition;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Distributes nutritional literature; or</text> </paragraph> <paragraph num="(3)"> <text>Provides services related only to the purchasing, preparation, and service of food to groups of people.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited institution” means a college or university accredited by a regional educational accrediting association through the Council for Higher Education Accreditation and the United States Department of Education.</text> </paragraph> <paragraph num="(2)"> <text>“Act” means the Maryland Licensed Dietitian-Nutritionists Act, Health Occupations Article, §§5-101—5-502, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2-1)"> <text>Aids in the Practice of Dietetics.</text> <paragraph num="(a)"> <text>“Aids in the practice of dietetics” means an individual directly or indirectly supervised by a licensed dietitian, licensed nutritionist, or licensed physician who assists in the practice of dietetics by following instructions in:</text> <paragraph num="(i)"> <text>Gathering and recording information for the purposes of assessing individual and community food practices and for assessing nutritional status using anthropometric, biochemical, clinical, dietary, and demographic data;</text> </paragraph> <paragraph num="(ii)"> <text>Providing nutrition information as part of preventive or restorative health care if the nutrition care plan, priorities, goals, and objectives for meeting nutrient needs were developed by a licensed practitioner; and</text> </paragraph> <paragraph num="(iii)"> <text>Applying standards for quality control in the areas of menu planning and procurement, food selection, production, assembly, distribution, and food safety and sanitation to ensure high quality nutritional care.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Aids in the practice of dietetics” does not include:</text> <paragraph num="(i)"> <text>Evaluation of nutritional status;</text> </paragraph> <paragraph num="(ii)"> <text>Formulation of nutrition standards;</text> </paragraph> <paragraph num="(iii)"> <text>Development or modification of diet instructions;</text> </paragraph> <paragraph num="(iv)"> <text>Evaluation of patient progress;</text> </paragraph> <paragraph num="(v)"> <text>Development of menu patterns for therapeutic diets; or</text> </paragraph> <paragraph num="(vi)"> <text>Establishing therapeutic diet production policies and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Applicant” means an individual who applies for licensure to practice dietetics in the State.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Dietetic Practice.</text> </paragraph> <paragraph num="(4-1)"> <text>“Certified nutrition specialist” means an individual certified by the Board for Certification of Nutrition Specialists.</text> </paragraph> <paragraph num="(5)"> <text>“Commission” means the Commission on Dietetic Registration of the American Dietetic Association.</text> </paragraph> <paragraph num="(6)"> <text>“Coordinated undergraduate program” means a dietetic program that combines didactic and clinical experience within a 4-year baccalaureate program.</text> </paragraph> <paragraph num="(7)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(8)"> <text>“Dietetic practice” means a practice through which the principles derived from integrating knowledge of food, biochemistry, physiology, management science, behavioral science, and social science to human nutrition are applied. Dietetic practice includes:</text> <paragraph num="(a)"> <text>Assessing individual and community food practices, and nutritional status for clinical, research, and program planning purposes using:</text> <paragraph num="(i)"> <text>Anthropometric data,</text> </paragraph> <paragraph num="(ii)"> <text>Biochemical data,</text> </paragraph> <paragraph num="(iii)"> <text>Clinical data,</text> </paragraph> <paragraph num="(iv)"> <text>Dietary data, and</text> </paragraph> <paragraph num="(v)"> <text>Demographic data;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Developing, establishing, and evaluating nutritional care plans that establish priorities, goals, and objectives for meeting nutrient needs for individuals or groups;</text> </paragraph> <paragraph num="(c)"> <text>Conducting nutrition counseling and education as a part of preventive or restorative health care throughout the life cycle;</text> </paragraph> <paragraph num="(d)"> <text>Determining, applying, and evaluating standards for food and nutrition services; and</text> </paragraph> <paragraph num="(e)"> <text>Applying scientific research to the role of food for the maintenance of health and the treatment of disease.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“License” means, unless the context requires otherwise, a license issued by the Board to practice dietetics.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed dietitian-nutritionist (LDN)” means an individual who is licensed by the Board to practice dietetics in the State.</text> </paragraph> <paragraph num="(11)"> <text>Medical Device.</text> <paragraph num="(a)"> <text>“Medical device” means a health care product used in the diagnosis, treatment, or prevention of disease.</text> </paragraph> <paragraph num="(b)"> <text>“Medical device” does not mean:</text> <paragraph num="(i)"> <text>A drug;</text> </paragraph> <paragraph num="(ii)"> <text>A surgical or dental instrument;</text> </paragraph> <paragraph num="(iii)"> <text>Physical therapy equipment;</text> </paragraph> <paragraph num="(iv)"> <text>X-ray apparatus; or</text> </paragraph> <paragraph num="(v)"> <text>A component part or accessory of any of the items listed in §B(11)(b) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Medical nutrition” means nutritional advice or counsel provided to an individual by a licensee, in the licensee's professional capacity, that is designed for an individual to alleviate a specific physiological complaint, condition, or symptom.</text> </paragraph> <paragraph num="(13)"> <text>“Nonmedical nutrition” means the application of basic principles of nutrition to food selection for the purpose of maintaining health.</text> </paragraph> <paragraph num="(14)"> <text>“Registered dietitian (RD)” means an individual registered by the Commission.</text> </paragraph> <paragraph num="(15)"> <text>“Supervision” means the management of an individual who aids in the practice of dietetics by a licensed dietitian-nutritionist who may or may not be on the premises.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Procedures."> <paragraph num="A."> <text>In order to obtain a license, the applicant shall:</text> <paragraph num="(1)"> <text>Submit to the Board an application on the form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay to the Board the application fee set forth in COMAR 10.56.02; and</text> </paragraph> <paragraph num="(3)"> <text>Submit evidence that the applicant:</text> <paragraph num="(a)"> <text>Is a registered dietitian, or</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements of Regulations .04, .05, and .07 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not consider an application completed until it has received all required materials.</text> </paragraph> <paragraph num="C."> <text>If the application is not complete with all required materials within 30 days after the Board receives the signed application form, the Board:</text> <paragraph num="(1)"> <text>Shall notify the applicant of the additional materials required; and</text> </paragraph> <paragraph num="(2)"> <text>May deny the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Academic Requirements."> <text>For initial licensure as a dietitian or nutritionist, an applicant shall submit proof of one of the following to the Board:</text> <paragraph num="A."> <text>Registration through the Commission on Dietetic Registration of the American Dietetic Association and receipt of, at a minimum, a degree from a college or university accredited by an educational accrediting association as required by the Commission on Dietetic Registration, including a minimum of 24 semester hours in:</text> <paragraph num="(1)"> <text>The field of human nutrition;</text> </paragraph> <paragraph num="(2)"> <text>Food and nutrition;</text> </paragraph> <paragraph num="(3)"> <text>Dietetics; or</text> </paragraph> <paragraph num="(4)"> <text>Food systems management with at least 3 semester hours from each of the following areas:</text> <paragraph num="(a)"> <text>Upper-division human nutrition related to disease;</text> </paragraph> <paragraph num="(b)"> <text>Upper-division food service systems management;</text> </paragraph> <paragraph num="(c)"> <text>Biochemistry or physiological chemistry, or advanced normal human nutrition; and</text> </paragraph> <paragraph num="(d)"> <text>Food science; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Certification by the Board for Certification of Nutrition Specialists and receipt of a master's or doctoral degree from a college or university accredited by an educational accrediting association as required by the Commission on Dietetic Registration in nutrition sciences with emphasis in:</text> <paragraph num="(1)"> <text>Human nutrition;</text> </paragraph> <paragraph num="(2)"> <text>Food and nutrition;</text> </paragraph> <paragraph num="(3)"> <text>Dietetics;</text> </paragraph> <paragraph num="(4)"> <text>Community nutrition;</text> </paragraph> <paragraph num="(5)"> <text>Public health nutrition; or</text> </paragraph> <paragraph num="(6)"> <text>Equivalent academic training such as nutrition education and food science.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Experience Requirements."> <paragraph num="A."> <text>Before licensure, an applicant shall have completed a preplanned professional experience program as described under Regulation .06 of this chapter.</text> </paragraph> <paragraph num="B."> <text>An applicant for licensure shall be considered to have met the experience requirements of this regulation if the applicant is a registered dietitian or a certified nutrition specialist at the time of application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="A Preplanned, Professional Experience Program."> <paragraph num="A."> <text>An applicant shall complete a Board-approved supervised, continuous, preplanned professional experience program. The applicant shall ensure that the experience program is accomplished within a span of 30 months and includes the following:</text> <paragraph num="(1)"> <text>A minimum of 100 hours shall be completed in each of the following areas:</text> <paragraph num="(a)"> <text>Assessing individual and community food practices and nutritional status using anthropometric, biochemical, clinical, dietary, and demographic data for clinical research and program planning purposes;</text> </paragraph> <paragraph num="(b)"> <text>Developing, establishing, and evaluating nutritional care plans that establish priorities, goals, and objectives for meeting nutrient needs for individuals or groups;</text> </paragraph> <paragraph num="(c)"> <text>Nutrition counseling and education as part of preventive or restorative health care throughout the life cycle;</text> </paragraph> <paragraph num="(d)"> <text>Determining, applying, and evaluating standards for food and nutrition services; and</text> </paragraph> <paragraph num="(e)"> <text>Applying scientific research to the role of food in the maintenance of health and the treatment of disease;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An additional 400 hours shall be completed within any combination of the five areas described in §A(1) of this regulation;</text> </paragraph> </paragraph> <paragraph num="A-1."> <text>The requirements of §A of this regulation may be satisfied in whole or in part by the clinical or research experience gained while completing a master's or doctoral degree if the experience:</text> <paragraph num="(1)"> <text>Is in human nutrition; and</text> </paragraph> <paragraph num="(2)"> <text>When combined with experience independently qualifying under §A(1) and (2) of this regulation, meets the overall 900-hour requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The preplanned professional experience program shall be under the supervision of:</text> <paragraph num="(1)"> <text>A licensed dietitian;</text> </paragraph> <paragraph num="(2)"> <text>A licensed nutritionist;</text> </paragraph> <paragraph num="(3)"> <text>A licensed physician;</text> </paragraph> <paragraph num="(4)"> <text>A registered dietitian;</text> </paragraph> <paragraph num="(5)"> <text>A certified nutrition specialist; or</text> </paragraph> <paragraph num="(6)"> <text>An individual with a doctoral degree with a major course of study in:</text> <paragraph num="(a)"> <text>Human nutrition;</text> </paragraph> <paragraph num="(b)"> <text>Nutrition education;</text> </paragraph> <paragraph num="(c)"> <text>Food and nutrition;</text> </paragraph> <paragraph num="(d)"> <text>Dietetics; or</text> </paragraph> <paragraph num="(e)"> <text>Food systems management that is conferred by a U.S. regionally accredited college or university.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Each supervisor shall:</text> <paragraph num="(1)"> <text>Plan all work assignments, instructions, and dietetic learning experiences to strengthen the competence of the applicant within the scope of practice as described in §A(1) and (2) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Keep a record of the applicant's:</text> <paragraph num="(a)"> <text>Activities;</text> </paragraph> <paragraph num="(b)"> <text>Program plan;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation instruments, including the number of hours spent fulfilling curriculum plans; and</text> </paragraph> <paragraph num="(d)"> <text>Transcript of the final evaluation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The applicant shall:</text> <paragraph num="(1)"> <text>Receive prior approval from the Board of the preplanned professional experience program or have the program approved by the Commission;</text> </paragraph> <paragraph num="(2)"> <text>Complete the program within 30 months after the applicant begins the program; and</text> </paragraph> <paragraph num="(3)"> <text>Submit documentation of the program on the documentation form provided by the Board.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may waive the requirement for prior approval and preplanning under §D(1) of this regulation if it determines that either or both could not reasonably have been obtained.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Examination Procedures."> <paragraph num="A."> <text>Unless waived by the Board as provided in §§B and C of this regulation, an applicant shall pass a Board-approved written examination before licensure.</text> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board may waive the examination requirement for an applicant who:</text> <paragraph num="(1)"> <text>Pays the application fee as provided in COMAR 10.56.02; and</text> </paragraph> <paragraph num="(2)"> <text>Is:</text> <paragraph num="(a)"> <text>A registered dietitian;</text> </paragraph> <paragraph num="(b)"> <text>A certified nutrition specialist; or</text> </paragraph> <paragraph num="(c)"> <text>Licensed in another state or country to practice dietetics and submits to the Board proof of current licensure which was obtained after passing an examination that the Board determines to be comparable to the examination for which the applicant is seeking waiver.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Types of Examination. To meet the examination requirements, an applicant shall successfully pass an examination approved by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Action on Application."> <paragraph num="A."> <text>The Board shall review all completed applications within 90 days of receipt of the completed application.</text> </paragraph> <paragraph num="B."> <text>The Board may delegate the initial review of applications to a committee of the Board.</text> </paragraph> <paragraph num="C."> <text>At the next regular meeting of the Board, the Board may approve or deny an application reviewed by the Board or its designee.</text> </paragraph> <paragraph num="D."> <text>Upon review of an application, the Board shall either:</text> <paragraph num="(1)"> <text>Approve the applicant for licensure; or</text> </paragraph> <paragraph num="(2)"> <text>Deny a license.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Ineligibility or Denial of Applications.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Determine an applicant is ineligible for a license if the applicant has:</text> <paragraph num="(i)"> <text>Not completed the academic requirements in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Not completed the experience requirements in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(iii)"> <text>Failed the examination requirements in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(iv)"> <text>Failed to remit a fee;</text> </paragraph> <paragraph num="(v)"> <text>Failed to properly complete the application form;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Deny a license if the applicant has:</text> <paragraph num="(i)"> <text>Violated the Act or any provision or these regulations; or</text> </paragraph> <paragraph num="(ii)"> <text>Been shown to have a lack of good moral character.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board denies a license under §E(1)(b) of this regulation, the Board or the Board's designee shall:</text> <paragraph num="(a)"> <text>Provide the applicant written notification of the Board's intent to deny and the basis for that denial; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the applicant's right to request a formal hearing to appeal the denial.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant who has been determined to be ineligible may reapply and shall submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>Board regulations; and</text> </paragraph> <paragraph num="(b)"> <text>The applicable provisions of the Act in effect at the time of the new application.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Issuance of License.</text> <paragraph num="(1)"> <text>If the Board approves an applicant for a license, the Board shall:</text> <paragraph num="(a)"> <text>Send the applicant a notice specifying that the applicant has qualified for a license; and</text> </paragraph> <paragraph num="(b)"> <text>Upon receipt of the license fee, issue a license to the applicant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall include on each license the:</text> <paragraph num="(a)"> <text>Full name of the licensee;</text> </paragraph> <paragraph num="(b)"> <text>Serial number assigned by the Board to the licensee; and</text> </paragraph> <paragraph num="(c)"> <text>Signature of the Chairman of the Board, under the seal of the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Unless the Board suspends or revokes the license of a licensed dietitian or licensed nutritionist, the license is effective for at least 2 years from the date issued and authorizes the person to practice dietetics while the license is effective.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Renewal."> <paragraph num="A."> <text>The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02.</text> </paragraph> <paragraph num="B."> <text>A licensee shall renew the license every 2 years.</text> </paragraph> <paragraph num="C."> <text>The Board shall send each licensee a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current license expires;</text> </paragraph> <paragraph num="(2)"> <text>Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee as specified in COMAR 10.56.02.</text> </paragraph> </paragraph> <paragraph num="D."> <text>At least 30 days before the current license or registration expires, the Board shall send the renewal notice by electronic means or first-class mail to the last known electronic or physical address of the licensee.</text> </paragraph> <paragraph num="E."> <text>The failure to receive a renewal notice does not excuse a licensee from complying with §B of this regulation.</text> </paragraph> <paragraph num="F."> <text>Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.56.05.</text> </paragraph> <paragraph num="G."> <text>Licensees applying for renewal are required to meet the current education requirements and be in good standing with:</text> <paragraph num="(1)"> <text>The Commission on Dietetic Registration; or</text> </paragraph> <paragraph num="(2)"> <text>The Board for Certification of Nutrition Specialists.</text> </paragraph> </paragraph> <paragraph num="H."> <text>After the expiration date of the license, the dietitian-nutritionist is no longer licensed to practice dietetics in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate an individual whose license has expired if the individual:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Meets the renewal requirements of this chapter and Health Occupations Article, §5-309, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Pays the license reinstatement and renewal fees as specified in COMAR 10.56.02;</text> </paragraph> <paragraph num="(4)"> <text>Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.56.05; and</text> </paragraph> <paragraph num="(5)"> <text>Applies to the Board for reinstatement of a license within 5 years of the license expiration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not reinstate the license of an individual who fails to apply for reinstatement within 5 years after the license expiration.</text> </paragraph> <paragraph num="C."> <text>An individual who fails to apply for reinstatement of a license within 5 years after expiration, may become licensed by meeting the requirements for obtaining an initial license under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Inactive Status."> <paragraph num="A."> <text>In accordance with Health Occupations Article, §5-309, Annotated Code of Maryland, a request by an active licensee to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(1)"> <text>Completed Board-approved inactive status application; and</text> </paragraph> <paragraph num="(2)"> <text>Payment of the required, non-refundable inactive status fee set forth in COMAR 10.56.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual:</text> <paragraph num="(1)"> <text>May apply for inactive status only if the individual’s license is still active and in good standing at the time the inactive status application request is made; and</text> </paragraph> <paragraph num="(2)"> <text>On inactive status is not authorized to and may not practice as a licensed dietitian-nutritionist.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An individual seeking to be reactivated shall be required, as a condition of reactivation, to submit:</text> <paragraph num="(1)"> <text>Proof of having completed the minimum continuing education requirements set forth under COMAR 10.56.05; and</text> </paragraph> <paragraph num="(2)"> <text>Payment of a reactivation fee set forth in COMAR 10.56.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Change of Mailing Address, Legal Name, or Email Address."> <paragraph num="A."> <text>A licensed dietitian-nutritionist shall give the Board written notice within 30 days of a change of:</text> <paragraph num="(1)"> <text>Mailing address;</text> </paragraph> <paragraph num="(2)"> <text>Legal name; or</text> </paragraph> <paragraph num="(3)"> <text>Email address if the licensee has previously submitted an email address to the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a $50 fee as set forth under COMAR 10.56.02.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§5-205, 5-301, 5-303, 5-306, and 5-308––5-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09, Licensure, adopted as an emergency provision effective February 9, 1988 (15:5 Md. R. 612); emergency status extended at 15:18 Md. R. 2144; emergency status expired December 31, 1988</annotation> <annotation type="History" subtype="Administrative History">Regulations .04 and .07 amended as an emergency provision effective August 8, 1988 (15:18 Md. R. 2144); emergency status expired December 31, 1988</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08, General Regulations, adopted effective February 20, 1989 (16:3 Md. R. 344)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 4, 1991 (18:2 Md. R. 150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 7, 1994 (21:22 Md. R. 1878); September 9, 1996 (23:18 Md. R. 1317); October 29, 2001 (28:21 Md. R. 1856); August 13, 2007 (34:16 Md. R. 1432); August 18, 2025 (52:16 Md. R.847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective November 7, 1994 (21:22 Md. R. 1878); October 29, 2001 (28:21 Md. R. 1856); August 18, 2025 (52:16 Md. R.847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 29, 2001 (28:21 Md. R. 1856); August 18, 2025 (52:16 Md. R.847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 4, 1991 (18:2 Md. R. 150); September 9, 1996 (23:18 Md. R. 1317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective February 4, 1991 (18:2 Md. R. 150); October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended as an emergency provision effective February 5, 1992 (19:4 Md. R. 469); emergency status expired August 7, 1992</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective August 8, 1992 (19:9 Md. R. 879); October 29, 2001 (28:21 Md. R. 1856); August 13, 2007 (34:16 Md. R. 1432); August 18, 2025 (52:16 Md. R. 847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, H, I amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended and Regulation .09 adopted as an emergency provision effective December 5, 1989 (16:26 Md. R. 2782); adopted permanently effective May 14, 1990 (17:9 Md. R. 1092); August 18, 2025 (52:16 Md. R. 847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08E amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C amended effective January 6, 1992 (18:26 Md. R. 2830); October 29, 2001 (28:21 Md. R. 1856)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 repealed and new Regulation .09 adopted effective August 18, 2025 (52:16 Md. R. 847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective August 18, 2025 (52:16 Md. R. 847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective August 18, 2025 (52:16 Md. R. 847 )</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 adopted effective August 18, 2025 (52:16 Md. R. 847)</annotation> </annotations> </chapter> <chapter num="02" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="General."> <text>The Board shall provide a copy of this chapter:</text> <paragraph num="A."> <text>Along with any application form or renewal form; and</text> </paragraph> <paragraph num="B."> <text>To any other person upon request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fee Schedule."> <text>The following fees are established by the Board for items and services provided under this subtitle:</text> <paragraph num="A."> <text>Application fee ... $75;</text> </paragraph> <paragraph num="B."> <text>License fee ... $225;</text> </paragraph> <paragraph num="C."> <text>License renewal fee due on or before October 31 of the renewal year ... $250;</text> </paragraph> <paragraph num="D."> <text>Duplicate license fee ... $25;</text> </paragraph> <paragraph num="E."> <text>License verification fee ... $50;</text> </paragraph> <paragraph num="F."> <text>Reinstatement fee due in addition to renewal fee submitted after October 31 of the renewal year ... $300;</text> </paragraph> <paragraph num="G."> <text>Returned check fee ... $25;</text> </paragraph> <paragraph num="H."> <text>Inactive status fee ... $75;</text> </paragraph> <paragraph num="I."> <text>Reactivation fee after inactive status ... $150;</text> </paragraph> <paragraph num="J."> <text>Late fee for failure to notify the Board within 30 days of change of address ... $50.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Change of Fees."> <text>Fees are subject to change by action of the Board of Dietetic Practice. Licensees and applicants shall be notified of the change.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Refunds."> <text>Fees are nonrefundable.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Assessment for Health Care Professionals."> <text>The Health Care Access and Cost Commission (HCACC) assesses a fee for health care professionals which the applicant shall pay at the time of license renewal as specified in COMAR 10.25.02.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§5-205, 5-206, 5-303, and 5-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 20, 1989 (16:3 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 7, 1998 (25:18 Md. R. 1435)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 3, 1992 (19:2 Md. R. 154); September 7, 1998 (25:18 Md. R. 1435)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 23, 1992 (19:16 Md. R. 1469); adopted permanently effective January 23, 1993 (19:21 Md. R. 1892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective April 24, 2001 (28:10 Md. R. 945); adopted permanently effective August 6, 2001 (28:15 Md. R. 1399)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 13, 2007 (34:16 Md. R. 1432); August 28, 2017 (44:17 Md. R. 836)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective July 28, 2008 (35:15 Md. R. 1349)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C, I amended as an emergency provision effective May 30, 2003 (30:12 Md. R. 785); amended permanently effective September 1, 2003 (30:17 Md. R. 1204)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02J adopted effective June 2, 1997 (24:11 Md. R. 794)</annotation> <annotation type="History" subtype="Administrative History">Regulation.03 adopted as an emergency provision effective July 23, 1992 (19:16 Md. R. 1469); adopted permanently effective January 23, 1993 (19:21 Md. R. 1892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective September 7, 1998 (25:18 Md. R. 1435)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective September 7, 1998 (25:18 Md. R. 1435)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethical Practices"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations govern any licensed dietitian (LD) or licensed nutritionist (LN) in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Public Protection."> <text>Each licensee accepts the obligation to protect the public by:</text> <paragraph num="A."> <text>Upholding the Code of Ethical Practices, as set forth in this chapter; and</text> </paragraph> <paragraph num="B."> <text>Reporting alleged violations of this chapter to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Code of Ethics."> <paragraph num="A."> <text>The primary concern of the licensee shall be the welfare of clients or patients.</text> </paragraph> <paragraph num="B."> <text>The licensee shall function with discretion and integrity in relationships with other licensees of the Board and other health professionals.</text> </paragraph> <paragraph num="C."> <text>The licensee shall practice dietetics or nutrition with honesty, integrity, self-respect, and fairness.</text> </paragraph> <paragraph num="D."> <text>The licensee may not:</text> <paragraph num="(1)"> <text>Knowingly participate in or condone behavior which is dishonest, fraudulent, or deceitful;</text> </paragraph> <paragraph num="(2)"> <text>Exploit relationships with clients or patients for personal advantage;</text> </paragraph> <paragraph num="(3)"> <text>Engage in sexual misconduct with clients or patients as set forth in Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Accept a client or patient for treatment or continue treatment unnecessarily, if benefit cannot reasonably be expected to accrue;</text> </paragraph> <paragraph num="(5)"> <text>Accept or receive, or both, remuneration for making or accepting referrals; or</text> </paragraph> <paragraph num="(6)"> <text>Suggest the ability to improperly influence any public body, official, person, or any individual on behalf of a client or patient.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Notify a referring professional if a decision is made not to accept or continue to treat a client, because benefit cannot reasonably be expected to accrue;</text> </paragraph> <paragraph num="(2)"> <text>Permit use of the licensee's name for the purpose of certifying that nutrition or dietetic services have been rendered, only if the licensee has provided or supervised the provision of those services;</text> </paragraph> <paragraph num="(3)"> <text>Cooperate with a lawful investigation conducted by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Remain free of conflicts of interest while fulfilling the objectives and maintaining the integrity of the dietetic or nutrition profession;</text> </paragraph> <paragraph num="(5)"> <text>Maintain confidentiality of information as follows:</text> <paragraph num="(a)"> <text>Safeguard information obtained in clinical or consulting relationships, including storage and disposal of written and electronic records;</text> </paragraph> <paragraph num="(b)"> <text>Reveal confidential information to others only with informed consent of the client or patient or the client's or patient's legal representative;</text> </paragraph> <paragraph num="(c)"> <text>Release health records only as permitted by Health-General Article, §§4-301—4-307, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>If supervising human research:</text> <paragraph num="(i)"> <text>Obtain voluntary and informed consent for participation, without any direct or implied deprivation or penalty for refusal to participate, and with due regard for a client's or patient's privacy and dignity; and</text> </paragraph> <paragraph num="(ii)"> <text>Comply with the Helsinki Declaration of 1975 as revised in 1983;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Practice nutrition or dietetics based on generally accepted scientific principles so as to minimize risk of harm to clients or patients;</text> </paragraph> <paragraph num="(7)"> <text>Exercise professional judgment within the limits of the licensee's qualifications, and seek counsel or make a referral when the client's or patient's needs are beyond the parameters of the licensee's education, capabilities, experience, or scope of practice;</text> </paragraph> <paragraph num="(8)"> <text>Obtain additional education, training, and supervision as needed to perform a new technique or service in a new specialty area;</text> </paragraph> <paragraph num="(9)"> <text>Use resources available, including referral to other specialists as needed, to maximize improvements in a client or patient;</text> </paragraph> <paragraph num="(10)"> <text>Exercise professional judgment in the use of evaluation and treatment procedures, and decline to carry out treatment if the licensee believes the treatment would be harmful, contraindicated, or unjustified, and notify the referring professional, if any, of such action;</text> </paragraph> <paragraph num="(11)"> <text>Terminate a professional relationship with a client or patient in an appropriate manner and offer to assist the client or patient in obtaining services from another professional if indicated;</text> </paragraph> <paragraph num="(12)"> <text>Make arrangements for another professional to address the needs of a client or patient as appropriate, during a period of anticipated absence from professional availability;</text> </paragraph> <paragraph num="(13)"> <text>Assume responsibility and accountability for personal competence in practice as follows:</text> <paragraph num="(a)"> <text>Keep written treatment records of any client or patient under the licensee's care, and for a period of not less than 5 years following termination of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Include in the records required by §E(13)(a) of this regulation a patient's or client's:</text> <paragraph num="(i)"> <text>Condition;</text> </paragraph> <paragraph num="(ii)"> <text>Assessment results;</text> </paragraph> <paragraph num="(iii)"> <text>Treatment modalities; and</text> </paragraph> <paragraph num="(iv)"> <text>Plan of care;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Meet the continuing education requirements as set forth in COMAR 10.56.05;</text> </paragraph> <paragraph num="(d)"> <text>Delegate responsibilities only to the extent set forth in COMAR 10.56.01;</text> </paragraph> <paragraph num="(e)"> <text>Provide supervision as required under COMAR 10.56.01; and</text> </paragraph> <paragraph num="(f)"> <text>Take corrective action if an individual supervised by the licensee performs nutritional services incorrectly;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>Provide sufficient information to enable a client or a patient to make informed decisions regarding treatment, including:</text> <paragraph num="(a)"> <text>The purpose and nature of any evaluation, treatment, educational, or training procedure;</text> </paragraph> <paragraph num="(b)"> <text>The estimated cost of each stage of a procedure or of the entire treatment;</text> </paragraph> <paragraph num="(c)"> <text>The reasonable expectations of the professional relationship;</text> </paragraph> <paragraph num="(d)"> <text>The right to withdraw from treatment at any time; and</text> </paragraph> <paragraph num="(e)"> <text>Notification that observation, electronic taping, recording, or filming procedures may not be used unless the client consents;</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Promote or endorse products or procedures, or both, only in a manner that is not false or misleading;</text> </paragraph> <paragraph num="(16)"> <text>Accurately present professional qualifications and credentials including educational, experience, and certification affiliations; and</text> </paragraph> <paragraph num="(17)"> <text>Attempt to correct others who misrepresent the licensee's qualifications or affiliation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Selling of nutritional products by a licensee is ethical only with the following written disclosures:</text> <paragraph num="(1)"> <text>That the product is sold as a convenience and the client or patient is not obligated to purchase the product;</text> </paragraph> <paragraph num="(2)"> <text>That the product may be purchased from another source; and</text> </paragraph> <paragraph num="(3)"> <text>That the price and amount of any profit gained for the product is made clear to the client or patient.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If a licensee experiences a substance-abuse problem that impairs professional practice, the licensee shall seek professional treatment and contact the Board's dietetic rehabilitation committee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sexual Misconduct."> <paragraph num="A."> <text>A licensed dietitian or licensed nutritionist may not engage in sexual misconduct in the practice of dietetics.</text> </paragraph> <paragraph num="B."> <text>Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client or patient in the context of a professional evaluation, treatment, procedure, or service to the client or patient, regardless of the setting in which the professional service is provided;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client or patient under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Requesting sexual favors of a client or patient;</text> </paragraph> <paragraph num="(4)"> <text>Inappropriate touching of a client or patient in a sexual manner;</text> </paragraph> <paragraph num="(5)"> <text>Therapeutically unnecessary discussion of sexual matters or other verbal conduct of a sexual nature while treating a client or patient;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs or video tapes of a client or patient for sexual purposes; or</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of staff or students.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties."> <text>Violation of Regulations .02—.04 of this chapter may result in the Board taking action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 5-102, and 5-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 20, 1989 (16:3 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 recodified to Regulation .04 effective July 24, 2000 (27:14 Md. R. 1342)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02 and .03 adopted effective July 24, 2000 (27:14 Md. R. 1342)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 16, 2001 (28:7 Md. R. 691)</annotation> </annotations> </chapter> <chapter num="04" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations apply to all formal hearings before the State Board of Dietetic Practice.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the:</text> <paragraph num="(1)"> <text>Date, time, and place of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>Issues or charges involved in the proceeding, provided, however, that if by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issues is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services upon a party shall be by delivery of the charging document and copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>Each party appearing at formal hearings shall have the right to appear in proper person or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Procedures."> <paragraph num="A."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §A(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than as listed in §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(a)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Prehearing Conferences. The Board may set prehearing conferences as it deems appropriate.</text> </paragraph> <paragraph num="C."> <text>Oaths and Subpoenas.</text> <paragraph num="(1)"> <text>The Board may issue subpoenas, administer oaths and compel the attendance of witnesses and the production of physical evidence before it from witnesses upon whom process is served anywhere within the State as in civil cases in the circuit court of the county or of Baltimore city, by subpoena issued over the signature of the Chairman or Secretary and the seal of the Board.</text> </paragraph> <paragraph num="(2)"> <text>If, without lawful excuse, an individual disobeys a subpoena from the Board, or an order by the Board to take any oath, testify, or answer a question, then, on petition of the Board, a court of competent jurisdiction may punish the individual for contempt of court.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Motions filed by a party shall be accompanied by a memorandum of points and authorities and shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party. Any response shall be filed with the Board at least 5 working days before the hearing and a copy shall be served on the opposing party.</text> </paragraph> <paragraph num="E."> <text>If after due notice the individual against whom the action is contemplated fails or refuses to appear, the Board may hear and determine the matter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Board Majority. Each hearing shall be held before not less than a quorum of the Board unless the hearing authority is delegated pursuant to State Government Article, §10-207, Annotated Code of Maryland. A delegation of authority shall be subject to the provisions of State Government Article, §10-212, Annotated Code of Maryland. Board action shall be by majority vote of those Board members present at the hearing.</text> </paragraph> <paragraph num="B."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The Chairman, or in the Chairman's absence a member designated by the Chairman, shall be the presiding officer, or if in a delegated hearing, a hearing examiner shall be the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Admit evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence; and</text> </paragraph> <paragraph num="(e)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall be responsible for decorum in hearings and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board.</text> </paragraph> <paragraph num="(2)"> <text>The member of the Office of the Attorney General presenting the case on behalf of the Board shall have all the following rights:</text> <paragraph num="(a)"> <text>The submission of evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>Filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Order of Procedure. The State shall present its case first. Then the respondent shall present his case. After this the State may present rebuttal.</text> </paragraph> <paragraph num="E."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Each party has the right to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine witnesses called by the Board or other party;</text> </paragraph> <paragraph num="(c)"> <text>Present summation and argument and file objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a party is represented by counsel, the submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by this counsel.</text> </paragraph> <paragraph num="(4)"> <text>Witnesses.</text> <paragraph num="(a)"> <text>The presiding officer, or any person designated by the presiding officer for the purpose, may examine any witness called to testify.</text> </paragraph> <paragraph num="(b)"> <text>The presiding officer may call as witness any person in attendance at the hearing.</text> </paragraph> <paragraph num="(c)"> <text>Any member of the Board may examine any witness called to testify.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimonies, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed unless requested by a party or by the Board. The cost of any typewritten transcripts of any proceedings or part of them shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <paragraph num="A."> <text>Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law.</text> </paragraph> <paragraph num="B."> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or attorney of record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>A party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on him of the decision and order.</text> </paragraph> <paragraph num="B."> <text>An order of the Board may not be stayed pending review.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeals."> <text>A person whose license has been revoked or suspended by the Board, or any person placed on probation or reprimand under the regulations in this chapter, may appeal the Board's decision as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§5-204, 5-205, 5-312, and 5-513; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 20, 1989 (16:3 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 2, 2000 (27:19 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 2, 2000 (27:19 Md. R. 1726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E adopted effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, B amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>These regulations establish continuing education requirements for licensed dietitians and licensed nutritionists in the State of Maryland.</text> </paragraph> <paragraph num="B."> <text>The objectives of these regulations are the:</text> <paragraph num="(1)"> <text>Maintenance of professional competency; and</text> </paragraph> <paragraph num="(2)"> <text>Improvement of professional skills.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Continuing education” means additional professional education by means of academic course work, seminars, lectures, journal clubs, skills development, professional reading, independent learning, study groups, publications, research, professional presentations, case presentations, exhibits, posters, advanced certifications, and professional leadership or other forms of continuing professional education approved by the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Continuing education unit” means a licensee's participation for 1 hour in an approved continuing education experience.</text> </paragraph> <paragraph num="(3)"> <text>“Renewal date” means the date upon which the license expires, as specified in the notice sent to the licensee by the Board in accordance with Health Occupations Article, §5-308(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Renewal period” means the 2-year period immediately before the renewal date.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Conditions of Licensure Renewal; Continuing Education Units Required."> <text>The Board shall renew a license for an additional 2-year period if the licensee:</text> <paragraph num="A."> <text>Otherwise is entitled to be licensed as set forth in COMAR 10.56.02;</text> </paragraph> <paragraph num="B."> <text>Pays to the Board the renewal fee as set forth in COMAR 10.56.02; and</text> </paragraph> <paragraph num="C."> <text>Submits to the Board:</text> <paragraph num="(1)"> <text>A renewal application on the form that the Board requires, and</text> </paragraph> <paragraph num="(2)"> <text>Satisfactory evidence of having completed, within the 2-year period before the renewal date, a minimum of 30 continuing education units approved by the Board or sponsored by, but not limited to, the following organizations:</text> <paragraph num="(a)"> <text>The Commission on Dietetic Registration, including approved Commission on Dietetic Registration Continuing Professional Education Providers;</text> </paragraph> <paragraph num="(b)"> <text>The Certification Board for Nutrition Specialists;</text> </paragraph> <paragraph num="(c)"> <text>The American College of Nutrition;</text> </paragraph> <paragraph num="(d)"> <text>American Society for Nutrition;</text> </paragraph> <paragraph num="(e)"> <text>The Accreditation Council for Continuing Medical Education;</text> </paragraph> <paragraph num="(f)"> <text>The Accreditation Council for Pharmaceutical Education;</text> </paragraph> <paragraph num="(g)"> <text>American Osteopathic Association;</text> </paragraph> <paragraph num="(h)"> <text>The Red Cross;</text> </paragraph> <paragraph num="(i)"> <text>United States Department of Agriculture, including, but not limited to, Agricultural Research Services;</text> </paragraph> <paragraph num="(j)"> <text>National Institutes of Health;</text> </paragraph> <paragraph num="(k)"> <text>Food and Drug Administration;</text> </paragraph> <paragraph num="(l)"> <text>Accredited colleges and universities;</text> </paragraph> <paragraph num="(m)"> <text>Accredited hospitals as defined in Health-General Article, §19-301, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(n)"> <text>The Maryland Department of Health.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifying Continuing Education."> <paragraph num="A."> <text>The licensee shall complete continuing education units relating to the practice of dietetics that foster improvement, advancement, and extension of the licensee's professional skill and knowledge relating to the practice of dietetics.</text> </paragraph> <paragraph num="B."> <text>Continuing education may include the categories listed in §§C—J of this regulation per each licensure renewal period.</text> </paragraph> <paragraph num="C."> <text>Category 1—Academic Course Work.</text> <paragraph num="(1)"> <text>In this category, continuing education may include:</text> <paragraph num="(a)"> <text>Graduate level academic course work from an accredited institution as defined in COMAR 10.56.01.02B(1) that will assist a licensee to carry out the licensee's professional responsibilities; and</text> </paragraph> <paragraph num="(b)"> <text>Not more than 15 hours of undergraduate course work that will assist a licensee to carry out the licensee's professional responsibilities, including but not limited to:</text> <paragraph num="(i)"> <text>Management courses;</text> </paragraph> <paragraph num="(ii)"> <text>Foreign language training for translators of relevant texts; or</text> </paragraph> <paragraph num="(iii)"> <text>Educational methodology for teachers of dietetic practice and nutrition.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>One semester hour of academic course work is equivalent to 15 continuing education units.</text> </paragraph> <paragraph num="(3)"> <text>One trimester hour is equivalent to 12 continuing education units.</text> </paragraph> <paragraph num="(4)"> <text>One quarter hour is equivalent to 10 continuing education units.</text> </paragraph> <paragraph num="(5)"> <text>The licensee shall submit documentation of a transcript indicating that the course was completed for credit.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Category 2—Seminars, Lectures, Journal Clubs.</text> <paragraph num="(1)"> <text>This category may include seminars, workshops, journal clubs, or a Board-approved similar program, which shall be verified by any documentation requested by the Board.</text> </paragraph> <paragraph num="(2)"> <text>One hour of attendance is equivalent to 1 continuing education unit.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Category 3—Skills Development. This category may not exceed more than 6 continuing education credits, including, but not limited to:</text> <paragraph num="(1)"> <text>Cardiopulmonary resuscitation certification;</text> </paragraph> <paragraph num="(2)"> <text>Culinary classes;</text> </paragraph> <paragraph num="(3)"> <text>Research methodology; and</text> </paragraph> <paragraph num="(4)"> <text>Anthropometry courses.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Category 4—Professional Reading, Independent Learning, Study Groups. This category includes formalized professional reading, independent learning, and study groups, which shall be verified by any documentation requested by the Board and may not exceed 20 hours of continuing education credit.</text> </paragraph> <paragraph num="G."> <text>Category 5—Publications, Research, Professional Presentations, Case Presentations. This category may not exceed 15 hours for writing or editing publications, research, professional presentations, and case presentations, including, but not limited to:</text> <paragraph num="(1)"> <text>Books;</text> </paragraph> <paragraph num="(2)"> <text>Booklets;</text> </paragraph> <paragraph num="(3)"> <text>An original paper based on a licensee's research published in a professional peer-reviewed journal;</text> </paragraph> <paragraph num="(4)"> <text>An original technical article published in a professional journal;</text> </paragraph> <paragraph num="(5)"> <text>An abstract or book review; and</text> </paragraph> <paragraph num="(6)"> <text>Poster presentations.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Category 6—Exhibits, Posters. This category may not exceed 12 hours of attending exhibits and viewing posters.</text> </paragraph> <paragraph num="I."> <text>Category 7—Initial Advanced Certifications.</text> <paragraph num="(1)"> <text>This category may include initial advanced certifications awarded during the first renewal as approved by the Commission on Dietetic Registration of the American Dietetic Association and the Certification Board for Nutrition Specialists.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall consider advanced recertification under Category 2 as described in §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Category 8—Professional Leadership. This category may not exceed 6 hours of professional leadership, including, but not limited to, participation at professional association and regulatory board meetings.</text> </paragraph> <paragraph num="K."> <text>Category 9—Pro Bono Work.</text> <paragraph num="(1)"> <text>This category may not exceed 5 hours of pro bono work related to dietetic practice.</text> </paragraph> <paragraph num="(2)"> <text>Continuing education units may be earned for pro bono work at the rate of 1 continuing education unit for 1 hour of Board-approved pro bono work.</text> </paragraph> <paragraph num="(3)"> <text>The licensee shall provide to the Board a written application for approval of pro bono work. The application shall include:</text> <paragraph num="(a)"> <text>The location of the pro bono work;</text> </paragraph> <paragraph num="(b)"> <text>The type of work related to dietetic practice to be provided;</text> </paragraph> <paragraph num="(c)"> <text>The number of hours of actual work to be provided for which the licensee desires continuing education hours;</text> </paragraph> <paragraph num="(d)"> <text>A statement guaranteeing that the work provided no financial benefit to the licensee; and</text> </paragraph> <paragraph num="(e)"> <text>A description of how the work will enhance the licensee's ongoing education.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon completion of the pro bono work, the licensee shall submit written documentation from the facility as evidence of completion of pro bono hours to the Board.</text> </paragraph> <paragraph num="(5)"> <text>Continuing education units may not be granted for work that did not receive prior approval from the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Obtaining Board Approval for Continuing Education Activities."> <paragraph num="A."> <text>To obtain approval by the Board of programs and activities qualifying for continuing education units, the program's sponsor or the licensee shall complete and submit the appropriate form, along with any required supporting documentation, to the Board at the appropriate time as provided in this chapter.</text> </paragraph> <paragraph num="B."> <text>The required supporting documentation in §A of this regulation includes the following:</text> <paragraph num="(1)"> <text>For a program attended, signed certification by a program leader or instructor of the licensee's credit hours of participation in the program by certificate, letter on letterhead stationery of the sponsoring agency, or official continuing education validation form of the sponsoring agency;</text> </paragraph> <paragraph num="(2)"> <text>For publications, a copy of the title page and table of contents of a book or monograph, or a copy of a journal article;</text> </paragraph> <paragraph num="(3)"> <text>For completion of academic course work from an accredited institution as defined in COMAR 10.56.01.02B(1), an official transcript indicating that the course was taken and completed; and</text> </paragraph> <paragraph num="(4)"> <text>For a presentation, a copy of the text of the presentation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Prior Approval Programs.</text> <paragraph num="(1)"> <text>To obtain prior approval of a qualifying program, the program's sponsor shall submit the request for prior approval of the program to the Board at least 6 weeks before the date the program will be given.</text> </paragraph> <paragraph num="(2)"> <text>To obtain continuing education units for attending a program that has received the Board's prior approval, either the sponsor or the licensee shall document the licensee's attendance of the program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subsequent Approval of Programs and Activities. When there has been no prior approval by the Board of the program or activity undertaken by the licensee for which the licensee seeks continuing education units, the licensee shall submit a request for approval of the program or activity to the Board, on the appropriate form, along with documentation which shows that the program meets the qualifications for continuing education credit and that the licensee attended the program.</text> </paragraph> <paragraph num="E."> <text>Extension of Time.</text> <paragraph num="(1)"> <text>A licensed dietitian-nutritionist shall file a request in writing with the Board for an extension of time within which to complete continuing education requirements before October 1 of the renewal year.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall consider and render a decision on the request within 60 days of receiving the written request.</text> </paragraph> <paragraph num="(3)"> <text>The Board may grant an extension until January 31 of the following year and conditionally renew a license if the Board determines that:</text> <paragraph num="(a)"> <text>Failure to fulfill the requirements is clearly a result of illness or other circumstances beyond the control of the licensed dietitian-nutritionist; and</text> </paragraph> <paragraph num="(b)"> <text>The licensed dietitian-nutritionist readily and appropriately attempted to meet the requirements.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Continuing education units earned after October 31 of the second year to fulfill the conditions of an extension may be credited only to the preceding 2-year period.</text> </paragraph> <paragraph num="(5)"> <text>The Board shall audit a licensed dietitian-nutritionist who has been granted an extension of time for the completion of continuing education requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Waiver of Documentation of Continuing Education Units."> <text>If the Board determines that an applicant for licensure could not reasonably have anticipated the need for documentation of continuing education units at the time the work was completed, the Board may, in its discretion, consider any evidence produced by the applicant to substantiate that he has satisfied the requirements of Regulation .03 of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place an active licensee on inactive status if the licensee:</text> <paragraph num="(1)"> <text>Submits to the Board an application for inactive status on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the inactive status fee set by the Board under COMAR 10.56.02.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall reactivate the license of an individual placed on inactive status if the individual:</text> <paragraph num="(1)"> <text>Demonstrates completion of 15 continuing education units for each year the license has lapsed; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a reactivation fee as provided in COMAR 10.56.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reinstatement."> <paragraph num="A."> <text>Within 1 Year of Failed Renewal.</text> <paragraph num="(1)"> <text>Within 1 calendar year after the renewal date, the Board shall reinstate the license of a dietitian or nutritionist whose license was not renewed due to failure to complete continuing education requirements, if the dietitian or nutritionist completes within that year all or the remaining balance of 30 continuing education units required during the prior renewal period.</text> </paragraph> <paragraph num="(2)"> <text>Continuing education units applied to reinstate are not counted again toward meeting the continuing education requirement of the renewal period in which the continuing education units are taken.</text> </paragraph> </paragraph> <paragraph num="B."> <text>After 1 Year of Failed Renewal.</text> <paragraph num="(1)"> <text>If a dietitian or nutritionist applies to reinstate the dietitian's or the nutritionist's license within 1 to 5 calendar years after the last renewal date, the dietitian or nutritionist shall demonstrate completion of 15 continuing education units for each year the license has lapsed.</text> </paragraph> <paragraph num="(2)"> <text>A dietitian or nutritionist who fails to apply for reinstatement of a license within 5 years after the expiration of the license may become licensed by meeting the requirements for obtaining an initial license as stated in COMAR 10.56.01.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§5-205, 5-308(d), and 5-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 4, 1991 (18:2 Md. R. 150)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 7, 1994 (21:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 26, 2000 (27:12 Md. R. 1141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 13, 2007 (34:16 Md. R. 1432); March 12, 2018 (45:5 Md. R. 286)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04K adopted effective October 19, 2009 (36:21 Md. R. 1592)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective October 19, 2009 (36:21 Md. R. 1592)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 recodified to be Regulation .08 and new Regulation .07 adopted effective August 13, 2007 (34:16 Md. R. 1432)</annotation> </annotations> </chapter> <chapter num="06" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter permits the Board of Dietetic Practice to disclose investigative information to other agencies, or other entities, or both, under certain circumstances.</text> </paragraph> <paragraph num="B."> <text>A custodian may disclosure information in a certification, licensing, or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Disclosure for Compelling Public Purpose."> <text>A custodian may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, whether or not there has been a request for the information, under the following circumstances:</text> <paragraph num="A."> <text>The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>The information concerns a possible regulatory violation and is disclosed to a federal, state, or local regulatory authority which has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to the possible regulatory violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>The information concerns conduct by an individual which the custodian reasonably believes may pose a risk to the public health, safety, or welfare and is disclosed to a law enforcement authority, administrative official, or agency which regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §5-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 29, 2001 (28:21 Md. R. 1856)</annotation> </annotations> </chapter> <chapter num="07" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs advertising by licensed dietitians and licensed nutritionists in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means using any medium to call to the attention of the public the services one has to offer.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Dietetic Practice.</text> </paragraph> <paragraph num="(3)"> <text>“Dietitian or nutritionist” means an individual who holds a current license to practice dietetics in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>A dietitian or nutritionist may advertise dietetic services under the provisions of this chapter.</text> </paragraph> <paragraph num="B."> <text>An advertisement shall include the following:</text> <paragraph num="(1)"> <text>Name of licensee;</text> </paragraph> <paragraph num="(2)"> <text>Address or telephone number of practicing location; and</text> </paragraph> <paragraph num="(3)"> <text>Type of license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An advertisement may not include a statement:</text> <paragraph num="(1)"> <text>Containing misrepresentation of facts;</text> </paragraph> <paragraph num="(2)"> <text>Likely to mislead or deceive because in context the statement makes only a partial disclosure of relevant facts;</text> </paragraph> <paragraph num="(3)"> <text>Intended to or likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(4)"> <text>Relating to fees without reasonable disclosure of all variables needed to make the statement clear and nondeceptive to a layperson;</text> </paragraph> <paragraph num="(5)"> <text>Conveying the impression that the dietitian or nutritionist can influence improperly any public body, official, corporation, or any person on behalf of a patient;</text> </paragraph> <paragraph num="(6)"> <text>Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent person to misunderstand or be deceived;</text> </paragraph> <paragraph num="(7)"> <text>Containing representations that the dietitian or nutritionist is willing to perform any procedure that is illegal under federal or State law or regulation;</text> </paragraph> <paragraph num="(8)"> <text>That fails to state the type of license; or</text> </paragraph> <paragraph num="(9)"> <text>That cannot be verified by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A dietitian or nutritionist shall be accountable under this chapter if the dietitian or nutritionist uses an agent, advertising service, employer, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <paragraph num="A."> <text>A dietitian or nutritionist may not engage in solicitation, including but not limited to, in-person, telephone, electronic media, or direct mail solicitation which:</text> <paragraph num="(1)"> <text>Is fraudulent, overreaching, intimidating, or exerts undue influence; or</text> </paragraph> <paragraph num="(2)"> <text>Contains statements which would be improper under Regulation .03C of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A dietitian or nutritionist shall be accountable under this chapter if the dietitian or nutritionist uses an agent, advertising service, employer, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Penalties for Violation."> <text>A violation of this chapter pertaining to the use of advertising shall constitute unprofessional conduct and may result in disciplinary action against the dietitian or nutritionist under Health Occupations Article, §5-311, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §5-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 14, 2002 (29:20 Md. R. 1589)</annotation> </annotations> </chapter> <chapter num="08" heading="Tax Compliance Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Board of Dietetic Practice.</text> </paragraph> <paragraph num="(2)"> <text>“Delinquent” means the failure by a licensee to pay all undisputed taxes and unemployment insurance contributions, as determined by the Office of the Comptroller or the Secretary of Labor, that are payable to the Office of the Comptroller or the Secretary of Labor, in a manner satisfactory to the unit of the State responsible for collection of the payment.</text> </paragraph> <paragraph num="(3)"> <text>“Renewal license” means any license granted by the Board for the period immediately after a period for which the individual previously possessed the same or a substantially similar license.</text> </paragraph> <paragraph num="(4)"> <text>“Verification” means a written or electronic notification created by the unit of the State responsible for collection of taxes or unemployment insurance contributions attesting that the renewal applicant is no longer delinquent.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Outstanding Taxes or Unemployment Insurance Contributions."> <paragraph num="A."> <text>When a renewal applicant has been identified as delinquent by the Office of the Comptroller or the Maryland Department of Labor, the Board shall issue a written notice to the renewal applicant stating that:</text> <paragraph num="(1)"> <text>The renewal applicant has been identified by the Office of the Comptroller or the Maryland Department of Labor, as delinquent in the payment of taxes or unemployment insurance contributions as applicable; and</text> </paragraph> <paragraph num="(2)"> <text>The renewal license will be withheld until verification is received by the Board from the unit of the State responsible for collection of taxes or unemployment insurance contributions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board does not receive a verification within 60 days after the expiration date of the current license, the licensee may be considered for reinstatement under Health Occupations Article, §5-309, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213 and 5-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 15, 2004 (31:5 Md. R. 450)</annotation> </annotations> </chapter> <chapter num="09" heading="Disciplinary Sanctions and Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the standards by which the Board may impose a disciplinary sanction, civil fine, or administrative monetary penalty, not to exceed:</text> <paragraph num="A."> <text>$5,000, on an individual licensed under Health Occupations Article, Title 5, Annotated Code of Maryland, for an act or omission prohibited under Health Occupations Article, §5-311, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>$50,000 on an individual who violates Health Occupations Article, §5-401 or 5-402, Annotated of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Dietetic Practice.</text> </paragraph> <paragraph num="(2)"> <text>“Civil fine” means a monetary fine imposed by the Board in accordance with Health Occupations Article, §5-403, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means an individual licensed by the Board to practice dietetics.</text> </paragraph> <paragraph num="(4)"> <text>“Penalty” means monetary penalty.</text> </paragraph> <paragraph num="(5)"> <text>“Sanction” means a disciplinary action reprimanding, restricting, suspending or revoking a licensee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty."> <paragraph num="A."> <text>After a hearing under Health Occupations Article, §5-312, Annotated Code of Maryland, and COMAR 10.56.04, and subject to the guidelines set forth in Regulation .05 of this chapter, the Board may discipline a licensee or impose an administrative monetary penalty of $5,000 or less on a licensee who is found to have committed a violation of Health Occupations Article, Title 5, Annotated Code of Maryland, and this subtitle.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a penalty under §A of this regulation:</text> <paragraph num="(1)"> <text>In addition to suspension or revocation of a license; or</text> </paragraph> <paragraph num="(2)"> <text>Instead of suspension of a license.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Mitigating and Aggravating Factors to be Considered in the Assessment of a Sanction or Penalty."> <text>Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following:</text> <paragraph num="A."> <text>Mitigating factors:</text> <paragraph num="(1)"> <text>The licensee’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The licensee self-reported the violation to the board;</text> </paragraph> <paragraph num="(3)"> <text>The licensee’s full and voluntary admissions of misconduct to the board and cooperation during board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>The licensee implemented remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee made timely good-faith effort to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm to public or adverse impact;</text> </paragraph> <paragraph num="(9)"> <text>The licensee’s conduct was an isolated incident and not likely to recur; and</text> </paragraph> <paragraph num="(10)"> <text>The licensee’s prior community service and present value to the community; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating factors:</text> <paragraph num="(1)"> <text>The licensee has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The licensee was motivated to perform the violation by his or her financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the patient or patients;</text> </paragraph> <paragraph num="(7)"> <text>The licensee attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(8)"> <text>The licensee concealed, falsified or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(9)"> <text>The licensee failed to cooperate with the investigation;</text> </paragraph> <paragraph num="(10)"> <text>Previous attempts at rehabilitation of the licensee were unsuccessful; and</text> </paragraph> <paragraph num="(11)"> <text>The licensee committed the violation under the guise of treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The existence of one or more of these factors does not impose on the Board or an administrative law judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this subtitle.</text> </paragraph> <paragraph num="D."> <text>Nothing in this regulation requires the Board or an administrative law judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Guidelines for Disciplinary Sanctions."> <paragraph num="A."> <text>Subject to the provisions of this section, the Board may impose the following sanctions and penalties for violations of the Maryland Licensed Dietitian-Nutritionists Act and its regulations according to the minimum and maximum sanctions and penalties set forth as follows:</text> </paragraph> <paragraph num="B."> <text>If a licensee is found in violation of more than one category enumerated in this chapter, the ranges with the maximum sanction and the range with the maximum penalty associated with those categories shall be applied.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Payment of Penalties."> <paragraph num="A."> <text>A licensee or unlicensed individual shall pay to the Board a penalty or civil fine imposed under this chapter by the date the Board’s order is issued, unless the Board’s order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §5-313, Annotated Code of Maryland, does not automatically stay payment of a penalty or civil fine imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter into the State's General Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Civil Fines."> <paragraph num="A."> <text>The Board may impose a civil fine of no less than $1,000 and no more than $50,000 against an individual who:</text> <paragraph num="(1)"> <text>Practices dietetics without a license in violation of Health Occupations Article, §5-401, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Misrepresents or implies to the public by use of the protected titles in violation of Health Occupations Article, §5-402, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Factors to be used in determining the amount of the fine may include, but are not be limited to, the following:</text> <paragraph num="(1)"> <text>The extent to which the individual derived any financial benefit from the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(2)"> <text>The willfulness of the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(3)"> <text>Actual or potential harm caused by the unauthorized practice or misrepresentation of title;</text> </paragraph> <paragraph num="(4)"> <text>The cost of the investigation; and</text> </paragraph> <paragraph num="(5)"> <text>The length of time in which the individual engaged in the unauthorized practice or misrepresentation of title.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 5-205, 5-206, 5-311, 5-311.1, and 5-403(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 13, 2007 (34:16 Md. R. 1432)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 16, 2012 (39:7 Md. R. 495)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 2, 2015 (42:4 Md. R. 434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 2, 2015 (42:4 Md. R. 434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective March 2, 2015 (42:4 Md. R. 434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective March 2, 2015 (42:4 Md. R. 434)</annotation> </annotations> </chapter> <chapter num="10" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of dietetics using telehealth as an adjunct to, or replacement for, in-person patient visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to the Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Dietetic Practice.</text> </paragraph> <paragraph num="(3)"> <text>“In-person” means within the physical presence of the patient.</text> </paragraph> <paragraph num="(4)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(5)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth practitioner” means a Maryland licensed dietician performing telehealth services within their respective scope of practice</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure."> <text>Subject to the provisions of Health Occupations Article, §5-301, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a patient located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before providing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the patient receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the patient’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license number and type; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of the recommended treatment plan;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a patient’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify patients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the patient’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the patient in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the patient is in Maryland and identify the specific practice setting in which the patient is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the patient’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person dietetic practice appointments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Evaluation."> <paragraph num="A."> <text>A dietician who practices telehealth shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing a treatment plan through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the patient, provide or refer a patient to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a patient based solely on an online questionnaire</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a telehealth practitioner who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1901—1903, 1-1001—1-1006, and 5-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 798)</annotation> </annotations> </chapter> </subtitle> <subtitle num="57" heading="Board for the Certification of Residential Child Care Program Professionals"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Acting program administrator” means an individual approved by the Board to practice as an interim residential child care program administrator for 180 days unless the time period is extended by the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Automatic sponsor” means an organization that is not required to apply to the Board for approval of sponsorship of continuing education.</text> </paragraph> <paragraph num="(3)"> <text>“Authorized sponsor” means an organization or individual that has been approved by the Board to provide continuing education programs.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board for the Certification of Residential Child Care Program Professionals.</text> </paragraph> <paragraph num="(5)"> <text>“Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </paragraph> <paragraph num="(6)"> <text>“Certificate” means a certificate issued by the Board to practice as a:</text> <paragraph num="(a)"> <text>Certified residential child care program administrator; or</text> </paragraph> <paragraph num="(b)"> <text>Certified residential child and youth care practitioner.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certified program administrator” means an individual who is:</text> <paragraph num="(a)"> <text>Certified by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Responsible for the day-to-day management and operation of a residential child care program and for assuring the care, treatment, safety, and protection of children.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Certified Residential Child and Youth Care Practitioner.</text> <paragraph num="(a)"> <text>“Certified residential child and youth care practitioner” means an individual who is:</text> <paragraph num="(i)"> <text>Certified by the Board; and</text> </paragraph> <paragraph num="(ii)"> <text>Assigned to perform the direct responsibilities related to activities of daily living, self-help, and socialization skills in a residential child care program under the direction of a certified program administrator.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Certified residential child and youth care practitioner” does not include an individual assigned to perform the direct responsibilities related to activities of daily living, self-help, and socialization skills in a residential child care program licensed by the Developmental Disabilities Administration.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Chief Administrator” means the individual, regardless of title, who is appointed by the governing body of a residential child care program as having the responsibility for the overall administration of the program.</text> </paragraph> <paragraph num="(10)"> <text>“Child protective services background clearance” means a search by a local department of social services of a central registry established under Family Law Article, Title 5, Subtitle 7, Annotated Code of Maryland, for information about child abuse and neglect investigations relating to an individual.</text> </paragraph> <paragraph num="(11)"> <text>“Client” means children and youth placed in the residential child care program.</text> </paragraph> <paragraph num="(12)"> <text>“Completed application” means an application submitted to the Board that contains sufficient information for the Board to make a decision on the application.</text> </paragraph> <paragraph num="(13)"> <text>“Continuing education” means additional professional education by means of undergraduate or postgraduate studies, institutes, seminars, lectures, conferences, workshops, or other forms of continuing professional education approved by the Board.</text> </paragraph> <paragraph num="(14)"> <text>“Continuing education unit” means a certified program administrator or certified residential child and youth care practitioner participation for 1 hour in an approved continuing education experience.</text> </paragraph> <paragraph num="(15)"> <text>“Day-to-day management and operation” means the overall responsibility for the operation of a residential child care program as described in COMAR 10.57.02.01C.</text> </paragraph> <paragraph num="(16)"> <text>“Delinquent” means the failure by a certificate holder to pay all undisputed taxes and unemployment insurance contributions, as determined by the Office of the Comptroller or the Secretary of Labor, that are payable to the Office of the Comptroller or the Secretary of Labor, in a manner satisfactory to the unit of the State responsible for collection of the payment.</text> </paragraph> <paragraph num="(17)"> <text>“Examination” means a written test given or approved by the Board.</text> </paragraph> <paragraph num="(18)"> <text>Human Service Field.</text> <paragraph num="(a)"> <text>“Human service field” means, in the context of certification as a program administrator, having experience:</text> <paragraph num="(i)"> <text>As a human service professional as defined in COMAR 14.31.06.03B;</text> </paragraph> <paragraph num="(ii)"> <text>Serving children detained, committed, or under the jurisdiction of the Department of Juvenile Services; or</text> </paragraph> <paragraph num="(iii)"> <text>Serving children in residential child care programs under the jurisdiction of the Department of Human Services or the Maryland Department of Health.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Human service field” means, in the context of certification as a residential child and youth care practitioner, having experience:</text> <paragraph num="(i)"> <text>As a human service professional defined in COMAR 14.31.06.03B; or</text> </paragraph> <paragraph num="(ii)"> <text>Performing the direct responsibilities related to activities of daily living, self-help and socialization skills for children in a residential child care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Human service portfolio” means evidence provided to the Board on a form required by the Board documenting human service experience and mastery of core competencies as described in COMAR 10.57.03.</text> </paragraph> <paragraph num="(20)"> <text>“Inappropriate sexual language” means:</text> <paragraph num="(a)"> <text>A sexualized harassing comment;</text> </paragraph> <paragraph num="(b)"> <text>An eroticized or sexually provocative comment not reasonably associated with a health care matter; or</text> </paragraph> <paragraph num="(c)"> <text>An inappropriate discussion of a sexually related matter.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Licensing authority” means the department of State government that issued the residential child care program's license to operate in the State.</text> </paragraph> <paragraph num="(22)"> <text>“Practice of residential child care administration” means the exercise of final authority of any act or the making of any decision involved in the planning, organizing, directing, or controlling of the day-to-day operation of a residential child care program.</text> </paragraph> <paragraph num="(23)"> <text>“Renewal certificate” means any certificate granted by the Board for the period immediately after a period for which the individual previously possessed the same or a substantially similar certificate.</text> </paragraph> <paragraph num="(24)"> <text>“Renewal date” means the date upon which the certificate expires, as specified in the notice sent to the certified program administrator by the Board in accordance with Health Occupations Article, §20-310(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(25)"> <text>“Renewal period” means the 2-year period immediately before the renewal date.</text> </paragraph> <paragraph num="(26)"> <text>Residential Child Care Program.</text> <paragraph num="(a)"> <text>“Residential child care program” means an entity that provides care for children 24 hours per day within a structured set of services and activities that:</text> <paragraph num="(i)"> <text>Are designed to achieve specific objectives relative to the needs of the children served; and</text> </paragraph> <paragraph num="(ii)"> <text>Include the provision of food, clothing, shelter, education, social services, health, mental health, recreation, or any combination of those services and activities.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Residential child care program” includes the residential child care programs identified in COMAR 14.31.06.02A and licensed by the:</text> <paragraph num="(i)"> <text>Department of Human Services;</text> </paragraph> <paragraph num="(ii)"> <text>Maryland Department of Health; and</text> </paragraph> <paragraph num="(iii)"> <text>Department of Juvenile Services.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Residential child care program” does not include the individuals or programs identified in COMAR 14.31.06.02C.</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Residential child care supervisor” means an individual:</text> <paragraph num="(a)"> <text>That provides supervision to a residential child care practitioner; and</text> </paragraph> <paragraph num="(b)"> <text>Who is certified as either a residential child care program administrator or residential child and youth care practitioner.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Sexual behavior” means:</text> <paragraph num="(a)"> <text>A sexual act as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Sexual contact as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Sexual exploitation” means a situation in which the certified individual takes advantage of the unequal relationship between the certified residential child care program administrator or residential child and youth care practitioner and client or supervisee to obtain sexual favors.</text> </paragraph> <paragraph num="(30)"> <text>“Sexual harassment” means deliberate or repeated comment, advance, gesture, solicitation, request, or physical contact of a sexual nature.</text> </paragraph> <paragraph num="(31)"> <text>“Supervisee” means the individual to whom the certified residential child care program administrator or residential child and youth care practitioner provides professional, educational, or administrative supervision or direction.</text> </paragraph> <paragraph num="(32)"> <text>“Supervisory or administrative capacity” means having the shared responsibility for implementing the operation of a program(s) and supervising at least 1 member of staff as described in COMAR 10.57.02.02B.</text> </paragraph> <paragraph num="(33)"> <text>“Therapeutic deception” means a representation by the certified individual that sexual contact or sexual activity by or with the client is consistent with or part of the client's treatment.</text> </paragraph> <paragraph num="(34)"> <text>“Tiered certification” means the Board’s process and the requirements that provide for an individual to become certified as a residential child and youth care practitioner.</text> </paragraph> <paragraph num="(35)"> <text>“Verification” means a written or electronic notification created by the unit of the State responsible for collection of taxes or unemployment insurance contributions attesting that the renewal applicant is no longer delinquent.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§20-101 and 20-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective April 19, 2010 (37:8 Md. R. 617); September 14, 2015 (42:18 Md. R. 1175); November 7, 2016 (43:22 Md. R. 1223)</annotation> </annotations> </chapter> <chapter num="02" heading="Certification — Residential Child Care Program Administrators"> <regulation prefix="Regulation" num=".01" heading="Application Procedures."> <paragraph num="A."> <text>In order to obtain a certificate as a residential child care program administrator, the applicant shall submit to the Board:</text> <paragraph num="(1)"> <text>An application on the form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The application fee set forth in COMAR 10.57.07;</text> </paragraph> <paragraph num="(3)"> <text>Independent written verification from the applicant’s employer or employers describing the nature and duration of the applicant’s experience in the human service field;</text> </paragraph> <paragraph num="(4)"> <text>A certified copy of a transcript with a school seal from an accredited college or university to document the receipt of a baccalaureate or master's degree; and</text> </paragraph> <paragraph num="(5)"> <text>Evidence that the applicant:</text> <paragraph num="(a)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(b)"> <text>Has completed a State and national criminal history records check;</text> </paragraph> <paragraph num="(c)"> <text>Unless waived in accordance with Health Occupations Article, §20–303(d), Annotated Code of Maryland, has submitted to a child protective services background clearance;</text> </paragraph> <paragraph num="(d)"> <text>Meets the requirements of Regulations .02 and .03 of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>Is 21 years old or older; and</text> </paragraph> <paragraph num="(f)"> <text>Is responsible for the day-to-day management and operation of a residential child care program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Experience Required in §A(3) of this Regulation.</text> <paragraph num="(1)"> <text>At least one employment verification under §A(3) of this regulation shall be provided by a present or former supervisor.</text> </paragraph> <paragraph num="(2)"> <text>For individuals who are in a leadership role of a residential child care program and do not have a supervisor, an employment verification from the program's Chief Administrator or other appropriate program authority is sufficient to meet this requirement.</text> </paragraph> <paragraph num="(3)"> <text>Employment verification shall be submitted to the Board:</text> <paragraph num="(a)"> <text>On the form provided by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>In a sealed envelope that is signed by the writer on the back of the envelope over the seal.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Day-to-day management and operation of a residential child care program required in §A(5)(f) of this regulation includes, but is not limited to:</text> <paragraph num="(1)"> <text>Administering, directing, or managing the residential child care program to ensure that the basic needs of the child are met;</text> </paragraph> <paragraph num="(2)"> <text>Recruiting, hiring, training, and supervising staff;</text> </paragraph> <paragraph num="(3)"> <text>Developing and implementing an appropriate staffing plan based upon the needs of the children in the residential child care program and in accordance with applicable laws and regulations;</text> </paragraph> <paragraph num="(4)"> <text>Coordinating, supervising, and implementing the services provided to ensure the child has access to appropriate medical, psychosocial and educational services as established in the child's service plan;</text> </paragraph> <paragraph num="(5)"> <text>Maintaining records in a manner that conforms to the requirements of this chapter and other applicable laws and regulations;</text> </paragraph> <paragraph num="(6)"> <text>Monitoring the quality of services provided by the residential child care program; and</text> </paragraph> <paragraph num="(7)"> <text>Ensuring that all requirements of this chapter and other applicable laws and regulations are met.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board may not consider an application completed until it has received all required materials.</text> </paragraph> <paragraph num="E."> <text>An applicant shall be responsible for the payment of any costs required to obtain supporting documentation for an application.</text> </paragraph> <paragraph num="F."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after the receipt of an incomplete application of the materials that are required.</text> </paragraph> <paragraph num="(2)"> <text>If the applicant fails to provide the required documentation within 120 days, the Board may:</text> <paragraph num="(a)"> <text>Administratively close the application; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the application, pursuant to Regulation .04E of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is administratively closed or denied may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 20, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant whose application has been denied shall disclose on future applications that the applicant had been denied certification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Academic and Experience Requirements."> <paragraph num="A."> <text>Degrees and Experience. For certification as a certified program administrator, an applicant shall submit proof of one of the following to the Board:</text> <paragraph num="(1)"> <text>Receipt of a baccalaureate degree from an accredited college or university and 4 years experience in the human service field with at least 3 years in a supervisory or administrative capacity; or</text> </paragraph> <paragraph num="(2)"> <text>Receipt of a master's degree from an accredited college or university and 2 years experience in the human service field with at least 1 year in a supervisory or administrative capacity.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervisory or Administrative Capacity Required in §A of this regulation.</text> <paragraph num="(1)"> <text>Supervisory or administrative capacity required under §A of this regulation includes the responsibility for hiring, assigning duties, disciplining and rewarding, approving leave requests, and formally evaluating.</text> </paragraph> <paragraph num="(2)"> <text>Experience within the following settings may not be considered supervisory or administrative capacity experience:</text> <paragraph num="(a)"> <text>Child placing agency;</text> </paragraph> <paragraph num="(b)"> <text>Child placing institutional experience;</text> </paragraph> <paragraph num="(c)"> <text>Foster parenting; and</text> </paragraph> <paragraph num="(d)"> <text>Serving as a caregiver in a foster home.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Experience shall be obtained within 10 years before the application date.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Review of Foreign Credentials. An applicant shall:</text> <paragraph num="(1)"> <text>Provide proof of equivalency of the applicant's educational credentials to a baccalaureate degree or master's degree awarded from an accredited college or university in the United States; and</text> </paragraph> <paragraph num="(2)"> <text>Submit their educational credentials at the applicant's expense to an educational evaluation agency approved by the Board with the request that the evaluation report be sent directly to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Examination Procedures."> <paragraph num="A."> <text>Unless waived by the Board as provided in §D of this regulation, an applicant shall pass a Board-approved written examination before certification.</text> </paragraph> <paragraph num="B."> <text>A minimum passing score of 75 percent is required on the examination.</text> </paragraph> <paragraph num="C."> <text>In order to qualify for certification, an applicant shall pass the examination within 3 years of the first time the applicant takes the examination.</text> </paragraph> <paragraph num="D."> <text>Waiver of Examination. The Board may waive the examination requirement for an applicant who:</text> <paragraph num="(1)"> <text>Pays the application fee as provided in COMAR 10.57.07;</text> </paragraph> <paragraph num="(2)"> <text>Is certified as a program administrator in any other state that the Board determines has a comparable certification process; and</text> </paragraph> <paragraph num="(3)"> <text>Provides adequate evidence that:</text> <paragraph num="(a)"> <text>At the time the applicant was certified in the other state, the applicant was qualified to take the examination that then was required by the laws of this State;</text> </paragraph> <paragraph num="(b)"> <text>The applicant qualified for a certificate in the other state by passing an examination given in that or any other state;</text> </paragraph> <paragraph num="(c)"> <text>The applicant has completed a State and national criminal history records check; and</text> </paragraph> <paragraph num="(d)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20–303(d), Annotated Code of Maryland, the applicant has submitted to a child protective services background clearance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Reexamination.</text> <paragraph num="(1)"> <text>An applicant who fails the examination:</text> <paragraph num="(a)"> <text>May retake the examination three times within the 12-month period after a failed examination; and</text> </paragraph> <paragraph num="(b)"> <text>May not retake the examination within 6-months of failing the examination for the third time.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before or on the day of the repeat examination, the applicant shall pay to the Board the examination fee as established in COMAR 10.57.07.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may request a waiver of the 6-month waiting period after failure of the third examination upon proof of exceptional circumstances.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Applicants Requiring Special Accommodation.</text> <paragraph num="(1)"> <text>An applicant with a disability may request modifications in examination materials or procedures.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall make the request for modification in writing and include in the request the following:</text> <paragraph num="(a)"> <text>The applicant's name;</text> </paragraph> <paragraph num="(b)"> <text>The date of the examination to be modified; and</text> </paragraph> <paragraph num="(c)"> <text>A letter from the appropriate licensed professional which:</text> <paragraph num="(i)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(ii)"> <text>Provides information describing the accommodations required.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Requests for modification and supporting documentation shall be received by the application deadline.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Action on Application."> <paragraph num="A."> <text>Criminal History Record Information.</text> <paragraph num="(1)"> <text>Upon receipt of an applicant’s criminal history records information in accordance with Health Occupations Article, §20-303, Annotated Code of Maryland, the Board shall consider the following factors in determining whether to grant a certificate:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the applicant poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not issue a certificate if the criminal history record information required under Health Occupations Article, §20-303, Annotated Code of Maryland, has not been received.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon review of a completed application, the Board shall:</text> <paragraph num="(1)"> <text>Notify the applicant that the applicant is:</text> <paragraph num="(a)"> <text>Approved for certification; and</text> </paragraph> <paragraph num="(b)"> <text>Qualified to take the examination; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Deny certification.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Denial of Applications.</text> <paragraph num="(1)"> <text>The Board may deny certification if the applicant has:</text> <paragraph num="(a)"> <text>Not completed the academic and experience requirements in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Failed the examination requirements in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Failed to remit a fee;</text> </paragraph> <paragraph num="(d)"> <text>Failed to properly complete the application form;</text> </paragraph> <paragraph num="(e)"> <text>Violated Health Occupations Article, Title 20, Annotated Code of Maryland, or any provision of this subtitle; or</text> </paragraph> <paragraph num="(f)"> <text>Been shown to have a lack of good moral character.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board denies certification under §E(1)(e) or (f) of this regulation, the Board or the Board's designee shall:</text> <paragraph num="(a)"> <text>Provide the applicant written notification of the Board's intent to deny and the basis for that denial; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the applicant's right to request a formal hearing to appeal the denial.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant whose certification has been denied may reapply and shall submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 20, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Issuance of Certificate.</text> <paragraph num="(1)"> <text>If the Board approves an applicant for certification and the applicant passes the State Standards Examination, the Board shall:</text> <paragraph num="(a)"> <text>Send the applicant a notice specifying that the applicant has qualified for a certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a certificate, available online, to the applicant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall include on each certificate the:</text> <paragraph num="(a)"> <text>Full name of the certificate holder; and</text> </paragraph> <paragraph num="(b)"> <text>Serial number assigned by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Expiration and Renewal."> <paragraph num="A."> <text>Unless the Board suspends or revokes the certificate, the certification is effective for up to 2 years from the date issued and authorizes the individual to administer a residential child care program.</text> </paragraph> <paragraph num="B."> <text>At least 1 month before the certificate expires, the Board shall send to the certified program administrator, by electronic means or first-class mail to the last known electronic or physical address, a renewal notice that states:</text> <paragraph num="(1)"> <text>The date on which the current certificate expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall renew the certificate of a certified program administrator who:</text> <paragraph num="(1)"> <text>Otherwise is entitled to obtain a certificate;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a renewal fee set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on a form that the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with any continuing education and other qualifications and requirements set by the Board.</text> </paragraph> <paragraph num="(c)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20-310(f), Annotated Code of Maryland, evidence of application for a child protective services background clearance; and</text> </paragraph> <paragraph num="(d)"> <text>Evidence of having submitted to a State and national criminal history records check conducted by the Central Repository.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Criminal History Record Information.</text> <paragraph num="(1)"> <text>Upon receipt of an applicant’s criminal history records information in accordance with Health Occupations Article, §20-303, Annotated Code of Maryland, the Board shall consider the following factors in determining whether to grant a certificate:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the applicant poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not issue a certificate if the criminal history record information required under Health Occupations Article, §20-303, Annotated Code of Maryland, has not been received.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate the certificate of a program administrator who has failed to renew the certificate for any reason, if the individual:</text> <paragraph num="(1)"> <text>Has not had the certificate suspended or revoked;</text> </paragraph> <paragraph num="(2)"> <text>Meets the renewal requirements in Regulation .05 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Board the reinstatement fee set by the Board;</text> </paragraph> <paragraph num="(4)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>40 continuing education units taken within the last 2 years;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of having submitted to a State and national criminal history records check conducted by the Central Repository; and</text> </paragraph> <paragraph num="(c)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20-311(c), Annotated Code of Maryland, evidence of application for a child protective services background clearance; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Applies to the Board for reinstatement of the certificate within 5 years after the certificate expires.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not reinstate the certificate of a program administrator who fails to apply for reinstatement of the certificate within 5 years after the certificate expires. However, the program administrator may be certified by meeting the current requirements for obtaining a new certificate under this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Duplicate or Corrected Certificate."> <text>The Board shall issue a duplicate certificate, electronically, to the certificate holder if:</text> <paragraph num="A."> <text>The certificate holder has a change of name and does the following:</text> <paragraph num="(1)"> <text>Makes the request to the Board in writing on the form provided by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Provides appropriate legal documentation of the change; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board, as a result of its error, issues an incorrect certificate and the certificate holder:</text> <paragraph num="(1)"> <text>Notifies the Board in writing within 6 weeks of discovery of the incorrect certificate; or</text> </paragraph> <paragraph num="(2)"> <text>Does not receive electronic verification of the certificate within 6 weeks of issuance and provides a statement to the Board attesting to the unavailability of the certificate online within 4 months of the date the certificate was issued by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Resignation, Removal, or Death of a Program Administrator."> <paragraph num="A."> <text>If a program administrator resigns or is removed from a position as a program administrator by death or for any other unexpected cause, the residential child care program's Chief Administrator or other appropriate program authority shall immediately designate a certified program administrator to serve in that capacity.</text> </paragraph> <paragraph num="B."> <text>In the event a certified program administrator is not available, the residential child care program's Chief Administrator or other appropriate program authority may appoint a noncertified individual to serve in the capacity of acting program administrator for a period not exceeding 90 days if the individual:</text> <paragraph num="(1)"> <text>Is approved by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the minimum qualifications for a program administrator as set forth in COMAR 10.57.02.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Approval of Noncertified Individual to Serve as Acting Program Administrator.</text> <paragraph num="(1)"> <text>In order to obtain approval from the Board for the approval of a noncertified individual to serve as the acting program administrator, the residential child care program's Chief Administrator or other appropriate program authority shall immediately submit to the Board:</text> <paragraph num="(a)"> <text>An application on the form provided by the Board;</text> </paragraph> <paragraph num="(b)"> <text>The application fee set forth in COMAR 10.57.07;</text> </paragraph> <paragraph num="(c)"> <text>Written justification clarifying the reason why acting capacity is necessary, that includes:</text> <paragraph num="(i)"> <text>The name and title of the individual requesting approval of a non-certified individual, including mailing address, phone, and email address;</text> </paragraph> <paragraph num="(ii)"> <text>The qualifications and credentials of the individual selected for acting capacity; and</text> </paragraph> <paragraph num="(iii)"> <text>A summary of the efforts made by the residential child care program to recruit a certified program administrator;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>A copy of the individual's resume or curriculum vitae; and</text> </paragraph> <paragraph num="(e)"> <text>The State and national criminal history records check.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall review all of the documentation provided to verify that individual appointed meets the minimum qualifications of a program administrator as set forth in COMAR 10.57.02.</text> </paragraph> <paragraph num="(3)"> <text>Upon review of the request, the Board may:</text> <paragraph num="(a)"> <text>Approve the request for acting capacity;</text> </paragraph> <paragraph num="(b)"> <text>Approve the request for acting capacity with conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Deny request for acting capacity.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The 90 day period begins on the date that the program administrator leaves or is removed from the position as a program administrator.</text> </paragraph> <paragraph num="(5)"> <text>The Board may extend the 90 day period for a further period of not more than 30 days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Display of Certificate and Renewal Certificates."> <text>An individual certified as a residential child care program administrator shall display an original certificate and certificate card, or certificate renewal card in a conspicuous place in the office or place of business or employment of the program administrator.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§20-205, 20-301, 20-302, 20-303, 20-305—20-307, 20-310, 20-311, and 20-404, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 7, 2016 (43:22 Md. R. 1223)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, D amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="03" heading="Certification — Residential Child and Youth Care Practitioners"> <regulation prefix="Regulation" num=".01" heading="Application Procedures."> <paragraph num="A."> <text>In order to obtain a certificate as a residential child and youth care practitioner, the applicant shall submit to the Board:</text> <paragraph num="(1)"> <text>An application on the form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>The application fee set forth in COMAR 10.57.07; and</text> </paragraph> <paragraph num="(3)"> <text>Evidence the applicant:</text> <paragraph num="(a)"> <text>Meets the academic and experience requirements set forth in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Is of good moral character;</text> </paragraph> <paragraph num="(c)"> <text>Has completed a State and national criminal history records check;</text> </paragraph> <paragraph num="(d)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20–303(d), Annotated Code of Maryland, has a child protective services background clearance; and</text> </paragraph> <paragraph num="(e)"> <text>Has completed the process for certification under one of the tiers outlined in Regulation .10 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Age Requirement. An individual seeking certification as a residential child and youth care practitioner shall be either:</text> <paragraph num="(1)"> <text>21 years old or older; or</text> </paragraph> <paragraph num="(2)"> <text>At least 18 years old and have earned at least an associate's or bachelor's degree from an accredited college or university.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not consider an application completed until it has received all required materials.</text> </paragraph> <paragraph num="D."> <text>An applicant shall be responsible for the payment of any costs required to obtain supporting documentation for an application.</text> </paragraph> <paragraph num="E."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>If an incomplete application is submitted to the Board, the Board shall notify the applicant within 30 days after the receipt of the incomplete application of the materials that are required.</text> </paragraph> <paragraph num="(2)"> <text>If the applicant fails to provide the required documentation within 120 days, the Board may:</text> <paragraph num="(a)"> <text>Administratively close the application; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the application, pursuant to Regulation .08E of this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant whose application is administratively closed or denied may reapply and submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 20, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant whose application has been denied shall disclose on future applications that the applicant had been denied certification.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Academic and Experience."> <paragraph num="A."> <text>Academic Experience. For certification as a certified residential child and youth care practitioner, an applicant shall submit the following documents to the Board:</text> <paragraph num="(1)"> <text>A copy of a high school diploma or equivalent;</text> </paragraph> <paragraph num="(2)"> <text>Evidence of at least 2 years experience in the health and human services field; and</text> </paragraph> <paragraph num="(3)"> <text>Either:</text> <paragraph num="(a)"> <text>Successful completion of an approved residential child and youth care practitioner training program; or</text> </paragraph> <paragraph num="(b)"> <text>Official transcripts of an associate’s or bachelor’s degree from an accredited college or university.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Review of Foreign Educational Credentials.</text> <paragraph num="(1)"> <text>An applicant shall provide proof of equivalency of the applicant's educational credentials to a high school, associate's degree or bachelor's degree awarded from an accredited college or university in the United States.</text> </paragraph> <paragraph num="(2)"> <text>An applicant shall submit the applicant's educational credentials at the applicant's expense to an educational evaluation agency approved by the Board with the request that the evaluation report be sent directly to the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Certification."> <paragraph num="A."> <text>In order to obtain certification as a residential child and youth care practitioner by completion of an approved residential child and youth care training program, the applicant shall:</text> <paragraph num="(1)"> <text>Meet the age requirement set forth in Health Occupations Article, §20-302.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Board:</text> <paragraph num="(a)"> <text>The application;</text> </paragraph> <paragraph num="(b)"> <text>The application fee;</text> </paragraph> <paragraph num="(c)"> <text>Evidence of completion of a State and national criminal history records check as required by Regulation .01 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Evidence of completion of a minimum of 10 hours of an on-site program orientation at a private provider site;</text> </paragraph> <paragraph num="(e)"> <text>Evidence of completion of a Board-approved provider residential child and youth care training program; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pass a comprehensive residential child and youth care practitioner exam.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall notify applicants who have been approved to take the required comprehensive examination of:</text> <paragraph num="(1)"> <text>The applicant’s approval to sit for the examination; and</text> </paragraph> <paragraph num="(2)"> <text>All testing dates and locations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may waive the training program requirement set forth in Health Occupations Article, §20-302.1(f), Annotated Code of Maryland, for an applicant holding an Associate’s or Bachelor’s degree if the applicant:</text> <paragraph num="(1)"> <text>Passes an examination; and</text> </paragraph> <paragraph num="(2)"> <text>Meets other requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant for whom the required education, experience, training, and examination is waived in accordance with Health Occupations Article, §20-302.1(h), Annotated Code of Maryland, shall submit the following to the Board to become certified:</text> <paragraph num="(1)"> <text>The completed application;</text> </paragraph> <paragraph num="(2)"> <text>The application fee as required by COMAR 10.57.07;</text> </paragraph> <paragraph num="(3)"> <text>Evidence of a completed criminal history records check as required by Regulation .01 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>Before October 1, 2015, satisfactory evidence that the applicant has worked in the State as a residential child and youth care practitioner for at least 2 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Examination Procedures."> <paragraph num="A."> <text>An applicant shall pass a Board-approved examination before certification.</text> </paragraph> <paragraph num="B."> <text>A minimum passing score of 75 percent is required on the examination.</text> </paragraph> <paragraph num="C."> <text>An applicant shall pass the examination within 180 days of hire.</text> </paragraph> <paragraph num="D."> <text>Reexamination. An applicant who fails an examination may take the next examination given by the Board.</text> </paragraph> <paragraph num="E."> <text>Applicants Requiring Special Accommodation.</text> <paragraph num="(1)"> <text>An applicant with a disability may request modifications in examination materials or procedures.</text> </paragraph> <paragraph num="(2)"> <text>The applicant shall make the request for modification in writing and include in the request the following:</text> <paragraph num="(a)"> <text>The applicant's name;</text> </paragraph> <paragraph num="(b)"> <text>The date of the examination to be modified; and</text> </paragraph> <paragraph num="(c)"> <text>A letter from the appropriate licensed professional which:</text> <paragraph num="(i)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(ii)"> <text>Provides information describing the accommodations required.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Requests for modification and supporting documentation shall be received by the application deadline.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Action on Application."> <paragraph num="A."> <text>Criminal History Record Information.</text> <paragraph num="(1)"> <text>Upon receipt of an applicant’s criminal history records information in accordance with Health Occupations Article, §20-303, Annotated Code of Maryland, the Board shall consider the following factors in determining whether to grant a certificate:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the applicant poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not issue a certificate if the criminal history record information required under Health Occupations Article, §20-303, Annotated Code of Maryland, has not been received.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon review of a completed application, the Board shall do one of the following:</text> <paragraph num="(1)"> <text>Deny certification; or</text> </paragraph> <paragraph num="(2)"> <text>Notify the applicant that the applicant is qualified to take the examination.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Denial of Applications.</text> <paragraph num="(1)"> <text>The Board may deny certification if the applicant has:</text> <paragraph num="(a)"> <text>Not completed the academic and experience requirements in Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Failed the examination requirements in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Failed to remit a fee;</text> </paragraph> <paragraph num="(d)"> <text>Failed to properly complete the application form;</text> </paragraph> <paragraph num="(e)"> <text>Violated Health Occupations Article, Title 20, Annotated Code of Maryland, or any provision of this subtitle; or</text> </paragraph> <paragraph num="(f)"> <text>Been shown to lack good moral character.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board denies certification under §B(1)(e) or (f) of this regulation, the Board or the Board's designee shall:</text> <paragraph num="(a)"> <text>Provide the applicant written notification of the Board's intent to deny and the basis for that denial; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the applicant's right to request a formal hearing to appeal the denial.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant whose certification has been denied may reapply and shall submit with the new application proof of compliance with:</text> <paragraph num="(a)"> <text>This subtitle; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 20, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Issuance of Certificate.</text> <paragraph num="(1)"> <text>If the Board approves an applicant for certification and the applicant passes the examination, the Board shall:</text> <paragraph num="(a)"> <text>Send the applicant a notice specifying that the applicant has qualified for a certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a certificate, available online, to the applicant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall include on each certificate the:</text> <paragraph num="(a)"> <text>Full name of the certificate holder; and</text> </paragraph> <paragraph num="(b)"> <text>Serial number assigned by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Expiration and Renewal."> <paragraph num="A."> <text>Unless the Board suspends or revokes the certificate, the certification:</text> <paragraph num="(1)"> <text>Is effective for 2 years from the date issued; and</text> </paragraph> <paragraph num="(2)"> <text>Authorizes the individual to perform direct responsibilities related to activities of daily living, self-help, and socialization skills in a residential child care program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At least 1 month before the certificate expires, the Board shall send to the certified residential child and youth care practitioner by electronic or first-class mail to the last known electronic or physical address a renewal notice that states:</text> <paragraph num="(1)"> <text>The date on which the current certificate expires;</text> </paragraph> <paragraph num="(2)"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued; and</text> </paragraph> <paragraph num="(3)"> <text>The amount of the renewal fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall renew the certificate of a certified residential child and youth care practitioner who:</text> <paragraph num="(1)"> <text>Otherwise is entitled to obtain a certificate;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a renewal fee set by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on a form that the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of compliance with any continuing education and other qualifications and requirements set by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20-310(f), Annotated Code of Maryland, evidence of application for a child protective services background clearance; and</text> </paragraph> <paragraph num="(d)"> <text>Evidence of having submitted to a State and national criminal history records check conducted by the Central Repository.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Criminal History Record Information.</text> <paragraph num="(1)"> <text>Upon receipt of an applicant’s criminal history records information in accordance with Health Occupations Article, §20-303, Annotated Code of Maryland, the Board shall consider the following factors in determining whether to grant a certificate:</text> <paragraph num="(a)"> <text>The age at which the crime was committed;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(d)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(e)"> <text>Employment and character references; and</text> </paragraph> <paragraph num="(f)"> <text>Other evidence that demonstrates whether the applicant poses a threat to the public health or safety.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not issue a certificate if the criminal history record information required under Health Occupations Article, §20-303, Annotated Code of Maryland, has not been received.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate the certificate of a residential child and youth care practitioner who has failed to renew the certificate for any reason, if the individual:</text> <paragraph num="(1)"> <text>Has not had the certificate suspended or revoked;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the reinstatement fee as established in COMAR 10.57.07;</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>Evidence of completion of 20 continuing education units within the last 2 years;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of having submitted to a State and national criminal history records check conducted by the Central Repository; and</text> </paragraph> <paragraph num="(c)"> <text>Unless waived by the Board in accordance with Health Occupations Article, §20-311(c), Annotated Code of Maryland, evidence of application for a child protective services background clearance; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Applies to the Board for reinstatement of the certificate within 5 years after the certificate expires.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not reinstate the certificate of residential child and youth care practitioner who fails to apply for reinstatement of the certificate within 5 years after the certificate expires. However, the residential child and youth care practitioner may be certified by meeting the current requirements for obtaining a new certificate under this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Duplicate or Corrected Certificate."> <text>The Board shall issue a duplicate certificate, electronically, to the certificate holder if:</text> <paragraph num="A."> <text>The certificate holder has a change of name and does the following:</text> <paragraph num="(1)"> <text>Makes the request to the Board in writing on the form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Provides appropriate legal documentation of the change; and</text> </paragraph> <paragraph num="(3)"> <text>Pays the fee as specified in COMAR 10.57.07; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board, as a result of its error, issues an incorrect certificate and the certificate holder:</text> <paragraph num="(1)"> <text>Notifies the Board in writing within 6 weeks of discovery of the incorrect certificate; or</text> </paragraph> <paragraph num="(2)"> <text>Does not receive electronic verification of the certificate within 6 weeks of issuance and the certificate holder provides a statement to the Board attesting to the unavailability of the certificate online within 4 months of the date the certificate was issued by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Initial and Renewal Certificates."> <paragraph num="A."> <text>A certified residential child care and youth care practitioner shall provide to the residential child care program where they are employed:</text> <paragraph num="(1)"> <text>The certificate card; or</text> </paragraph> <paragraph num="(2)"> <text>Written verification from the Board of their certification.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon renewal of certification, the certified residential child and youth care practitioner shall provide to the residential child care program where they are employed:</text> <paragraph num="(1)"> <text>The certificate renewal card; or</text> </paragraph> <paragraph num="(2)"> <text>Written verification from the Board of the renewal of their certification.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§20-205, 20-301, 20-302.1, 20-303, 20-305, 20-307, 20-310, and 20-311, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter, Continuing Education, recodified to COMAR 10.57.04 effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted under a new Chapter, COMAR 10.57.03, Certification — Residential Child and Youth Care Practitioners, effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective September 29, 2014 (41:19 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted effective September 29, 2014 (41:19 Md. R. 1080)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 14, 2015 (42:18 Md. R. 1175)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 27, 2021 (48:26 Md. R. 1112)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective November 7, 2016 (43:22 Md. R. 1223)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 7, 2016 (43:22 Md. R. 1223)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 29, 2018 (45:2 Md. R. 69)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 7, 2016 (43:22 Md. R. 1223); December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective October 13, 2025 (52:20 Md. R.1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, C amended effective November 7, 2016 (43:22 Md. R. 1223)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D adopted effective December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective November 7, 2016 (43:22 Md. R. 1223)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="04" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Conditions of Certification Renewal; Continuing Education Units Required."> <paragraph num="A."> <text>The Board shall renew a certificate for an additional 2-year period if the certified program administrator:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be certified as set forth in COMAR 10.57.02;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the renewal fee as set forth in COMAR 10.57.06; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of having completed:</text> <paragraph num="(i)"> <text>For a certificate holder who obtained initial certification 2 years to 18 months before the renewal date, 40 continuing education units approved by the Board;</text> </paragraph> <paragraph num="(ii)"> <text>For a certificate holder who obtained initial certification within 18 months to 1 year before the renewal date, 30 continuing education units approved by the Board;</text> </paragraph> <paragraph num="(iii)"> <text>For a certificate holder who obtained initial certification within 1 year to 6 months before the renewal date, 20 continuing education units approved by the Board; and</text> </paragraph> <paragraph num="(iv)"> <text>For a certificate holder who obtained initial certification within 6 months before the renewal date, 10 continuing education units approved by the Board.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall renew the certificate for an additional 2-year period if the certified residential child and youth care practitioner:</text> <paragraph num="(1)"> <text>Otherwise is entitled to be certified as set forth in COMAR 10.57.03;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the renewal fee as established in COMAR 10.57.07; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of having completed, within the 2-year period before the renewal date, a minimum of 20 continuing education units approved by the Board.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Qualifying Continuing Education."> <paragraph num="A."> <text>The certified program administrator or certified residential child and youth care practitioner shall complete continuing education units that foster improvement, advancement, and extension of the certified program administrator's or certified residential child and youth care practitioner professional skill and knowledge relating to residential child care programs.</text> </paragraph> <paragraph num="B."> <text>Continuing education may include:</text> <paragraph num="(1)"> <text>Academic course work which qualifies for credit toward an undergraduate or a graduate degree from an accredited institution with one semester hour of academic course work equivalent to 15 continuing education units and one quarter hour of academic course work equivalent to 3.75 continuing education units;</text> </paragraph> <paragraph num="(2)"> <text>Workshops, seminars, symposiums, conferences, institutes, audiovisual self-study, and similar programs with 1 hour of attendance equivalent to 1 continuing education unit unless otherwise noted by an automatic or authorized sponsor;</text> </paragraph> <paragraph num="(3)"> <text>Publications with 1 hour of authoring, editing, or review equal to 1 continuing education unit, up to a maximum of 12 continuing education units in a renewal period;</text> </paragraph> <paragraph num="(4)"> <text>Presentations or teaching up to a maximum of twice the number of continuing education units available to a participant in the program;</text> </paragraph> <paragraph num="(5)"> <text>Staff development, including but not limited to an educational program planned by an agency to assist employees in becoming knowledgeable and competent in fulfilling role expectations within that agency with 1 hour of attendance equivalent to 1 continuing education unit;</text> </paragraph> <paragraph num="(6)"> <text>Invited speaker sessions, in-house seminars, and case conferences which are specifically designed for training, teaching, or both, with 1 hour of attendance equivalent to 1 continuing education unit;</text> </paragraph> <paragraph num="(7)"> <text>Attendance or presentation of programs offered at professional meetings of local, state, regional or international professional organizations or societies;</text> </paragraph> <paragraph num="(8)"> <text>Home-study courses provided by automatic sponsors or approved sponsors with proof of satisfactory completion up to a maximum of 10 continuing education units in a renewal period; or</text> </paragraph> <paragraph num="(9)"> <text>Attendance at Board meetings with 1 hour of attendance equivalent to 1 continuing education unit up to a maximum of 2 continuing education units.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Of the required continuing education units in each 2-year period, a maximum of 5 continuing education units may have a content area focusing on behavior management.</text> </paragraph> <paragraph num="D."> <text>Continuing education may not include certification or recertification in CPR or first aid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Obtaining Board Approval for Continuing Education Activities."> <paragraph num="A."> <text>Authorization of Sponsors of Continuing Education.</text> <paragraph num="(1)"> <text>The following organizations are recognized by the Board as automatic sponsors, and may sponsor, or approve, or both, continuing education:</text> <paragraph num="(a)"> <text>State, regional, national, or international associations for:</text> <paragraph num="(i)"> <text>Child and family services;</text> </paragraph> <paragraph num="(ii)"> <text>Dietetics;</text> </paragraph> <paragraph num="(iii)"> <text>Education;</text> </paragraph> <paragraph num="(iv)"> <text>Medical or allied health professionals;</text> </paragraph> <paragraph num="(v)"> <text>Professional counseling or therapy;</text> </paragraph> <paragraph num="(vi)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(vii)"> <text>Psychology;</text> </paragraph> <paragraph num="(viii)"> <text>Nursing; and</text> </paragraph> <paragraph num="(ix)"> <text>Social work;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>National, regional, or State accredited academic institutions offering academic courses or programs that apply to the field of residential child care;</text> </paragraph> <paragraph num="(c)"> <text>Agencies, institutions, organizations, or individuals authorized as automatic sponsors or approved sponsors of continuing education by the State Board of Social Work Examiners under COMAR 10.42.06; and</text> </paragraph> <paragraph num="(d)"> <text>Agencies, institutions, organizations, or individuals approved by any State licensing or certification boards under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following may be authorized to sponsor continuing education on application and approval by the Board:</text> <paragraph num="(a)"> <text>Licensed health professionals;</text> </paragraph> <paragraph num="(b)"> <text>Individuals with documented expertise in an area related to the practice of residential child care; and</text> </paragraph> <paragraph num="(c)"> <text>Agencies, institutions, or organizations not entitled to automatic authorization, but which provide continuing education programs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Application for Authorization to Sponsor Continuing Education.</text> <paragraph num="(1)"> <text>Applicants meeting the requirements of this chapter, who are not automatically authorized to sponsor continuing education programs, may apply to the Board for authorization to sponsor programs.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall:</text> <paragraph num="(a)"> <text>Provide the applicant with an application form; and</text> </paragraph> <paragraph num="(b)"> <text>Charge a fee for processing the application to sponsor continuing education programs as provided in COMAR 10.57.07.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant for authorization to sponsor continuing education shall submit an application on the form provided by the Board for approval of the sponsor's credentials at least 45 days before conducting the sponsor's first program.</text> </paragraph> <paragraph num="(4)"> <text>The Board shall give notice to an applicant that the applicant has been approved or disapproved as a sponsor.</text> </paragraph> <paragraph num="(5)"> <text>If approved, the sponsor shall be placed on a provisional status until five continuing education programs have been submitted and approved as meeting the objectives of this chapter.</text> </paragraph> <paragraph num="(6)"> <text>Within 30 days after conducting each of the five programs required to become an authorized sponsor, a provisional sponsor shall submit:</text> <paragraph num="(a)"> <text>A summary of attendance including the number of participants grouped by profession; and</text> </paragraph> <paragraph num="(b)"> <text>A summarized report of the participant evaluations of the continuing education program.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The Board shall notify the provisional sponsor in writing after receiving documentation of completion of all of the requirements of this regulation, if the requirements to be an authorized sponsor have been satisfied.</text> </paragraph> <paragraph num="(8)"> <text>The Board may waive the fee charged for processing the application, if the sponsor applying for authorization has demonstrated a capacity to offer acceptable continuing education programs to residential child care program professionals for no cost or nominal cost.</text> </paragraph> <paragraph num="(9)"> <text>Provisional sponsors may not be described as authorized sponsors in course description literature or other information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Authorized Sponsor Requirements.</text> <paragraph num="(1)"> <text>Authorized sponsors shall include the following in the program descriptions:</text> <paragraph num="(a)"> <text>The number of continuing education units which will be certified by the sponsor in a certificate awarded to the residential child care program professional;</text> </paragraph> <paragraph num="(b)"> <text>A statement that the named sponsor is authorized by the Board; and</text> </paragraph> <paragraph num="(c)"> <text>A statement that the named sponsor maintains responsibility for the program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board shall maintain a roster of authorized sponsors.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall require a sponsor to maintain documentation of continuing education for 4 years which includes:</text> <paragraph num="(a)"> <text>Registration and attendance records;</text> </paragraph> <paragraph num="(b)"> <text>Stated purpose;</text> </paragraph> <paragraph num="(c)"> <text>Content of presentation;</text> </paragraph> <paragraph num="(d)"> <text>Time and length of activity; and</text> </paragraph> <paragraph num="(e)"> <text>Participant evaluations.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may audit authorized sponsors at any time.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Suspension or Revocation of Sponsorship Authorization.</text> <paragraph num="(1)"> <text>Authorization as a sponsor or status as a provisional sponsor may be suspended or revoked if the sponsor does not comply with the requirements of §C of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall provide an opportunity for a hearing on request for reconsideration of the Board's decision to suspend or revoke sponsorship authorization, if a written request for reconsideration and hearing is received by the Board within 30 days after the affected party has been notified of the Board's action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reporting, Documenting, and Auditing Compliance with Continuing Education Requirements."> <paragraph num="A."> <text>A certified program administrator or certified residential child and youth care practitioner who has completed the continuing education requirements shall attest to that on a form supplied by the Board as part of the application for certificate renewal.</text> </paragraph> <paragraph num="B."> <text>The Board shall audit a percentage of certified program administrators and certified residential child and youth care practitioners, to be determined by the Board, for each reporting period.</text> </paragraph> <paragraph num="C."> <text>On request by the Board, a certified program administrator or certified residential child and youth care practitioner shall provide full documentation of the credit hours completed in accordance with the requirements of this regulation.</text> </paragraph> <paragraph num="D."> <text>Documentation. A certified program administrator or certified residential child and youth care practitioner shall provide to the Board:</text> <paragraph num="(1)"> <text>An official transcript for credit hours earned in a course taken for credit;</text> </paragraph> <paragraph num="(2)"> <text>A certificate of completion;</text> </paragraph> <paragraph num="(3)"> <text>If a certificate of completion is not available:</text> <paragraph num="(a)"> <text>Dates on which the program was presented;</text> </paragraph> <paragraph num="(b)"> <text>Names of the presenters;</text> </paragraph> <paragraph num="(c)"> <text>Topics presented; and</text> </paragraph> <paragraph num="(d)"> <text>An outline of the presentation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a certificate of completion is not available for an audiovisual instruction program or a home study course, proof of completion of the program or course, such as post-test passing score or other satisfactory proof as determined by the Board;</text> </paragraph> <paragraph num="(5)"> <text>Proof of presentations made;</text> </paragraph> <paragraph num="(6)"> <text>Reprints of publications;</text> </paragraph> <paragraph num="(7)"> <text>Dates, times, and names of participants in journal clubs and organized learning experiences; or</text> </paragraph> <paragraph num="(8)"> <text>If credit is claimed for instruction of students, letters from educational institutions.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Record and Retention for Active or Lapsed Certificate.</text> <paragraph num="(1)"> <text>Active Certificates.</text> <paragraph num="(a)"> <text>A certified program administrator or certified residential child and youth care practitioner shall retain records documenting completion of continuing education requirements for 1 year after the certificate renewal date for which the report of continuing education was submitted to the Board.</text> </paragraph> <paragraph num="(b)"> <text>Documentation may be requested by the Board at any time within that 1-year period.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Lapsed Certificate. A certified program administrator or certified residential child and youth care practitioner with a lapsed license shall:</text> <paragraph num="(a)"> <text>Retain records documenting completion of continuing education requirements for each 2-year period that the license was lapsed, up to a maximum of 80 credit hours; and</text> </paragraph> <paragraph num="(b)"> <text>File with the Board documentation of completion of continuing education units at the time of reinstatement.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Waiver of Continuing Education Requirements."> <text>The Board, at its discretion, may waive all or part of the requirements of Regulation .01A(3)(b) or B(3)(b) of this chapter.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §20-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.57.03 effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective March 3, 2014 (41:4 Md. R. 302)</annotation> </annotations> </chapter> <chapter num="05" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all individuals licensed by the Board including:</text> <paragraph num="A."> <text>Certified residential child care program administrators; and</text> </paragraph> <paragraph num="B."> <text>Certified residential child and youth care practitioners.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Public Protection."> <text>The residential child care program administrator and the residential child and youth care practitioner accept the obligation to protect the public by:</text> <paragraph num="A."> <text>Upholding the Code of Ethics, as set forth in this chapter; and</text> </paragraph> <paragraph num="B."> <text>Reporting alleged violations of this chapter to the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General Conduct."> <paragraph num="A."> <text>The primary concern of the residential child care program administrator and the residential child and youth care practitioner shall be the welfare of children and youth placed in the residential child care program.</text> </paragraph> <paragraph num="B."> <text>The certified residential child and youth care practitioner shall:</text> <paragraph num="(1)"> <text>Function with discretion and integrity in relationships with other health professionals;</text> </paragraph> <paragraph num="(2)"> <text>Carry out all duties with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Maintain documentation in the client's record which:</text> <paragraph num="(a)"> <text>Is legible;</text> </paragraph> <paragraph num="(b)"> <text>Accurately reflects the services provided, including treatment plans, treatment goals, and progress notes;</text> </paragraph> <paragraph num="(c)"> <text>Indicates the time and date services were provided;</text> </paragraph> <paragraph num="(d)"> <text>Protects the client's privacy by including only information directly relevant to the delivery of services;</text> </paragraph> <paragraph num="(e)"> <text>Is sufficient and timely to facilitate the delivery and continuity of services to be delivered in the future; and</text> </paragraph> <paragraph num="(f)"> <text>Is reasonably accessible for the period required by law, after termination of services;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Inform the Board of unethical conduct by a certified residential child care program administrator or residential child and youth care practitioner; and</text> </paragraph> <paragraph num="(5)"> <text>Inform the Board about an individual who is not certified by the Board but who represents that the individual is a residential child care program administrator or residential child and youth care practitioner, or offering to practice residential child care administration.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In the capacity or identity as a certified residential child care program administrator or certified residential child and youth care practitioner may not:</text> <paragraph num="(1)"> <text>Participate in or condone dishonest behavior, fraudulent activities, deceitful practices, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Misrepresent professional qualifications, education, experience, or affiliation;</text> </paragraph> <paragraph num="(3)"> <text>Exploit a relationship with a client for personal advantage or satisfaction;</text> </paragraph> <paragraph num="(4)"> <text>Engage in solicitation which amounts to fraud, intimidation, or undue influence, including but not limited to in-person, telephone, or direct mail solicitation;</text> </paragraph> <paragraph num="(5)"> <text>Practice, condone, or facilitate discrimination, or collaborate to discriminate on the basis of race, color, sex, sexual orientation, age, religion, national origin, marital status, political belief, disability, or other preference or personal characteristic, condition, or status with an individual or group of individuals;</text> </paragraph> <paragraph num="(6)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(7)"> <text>Share with another individual a confidence revealed by a client without the client's consent, except if there is danger to self or another individual , or for a compelling professional reason; or</text> </paragraph> <paragraph num="(8)"> <text>Enter into a nonprofessional, social, or dual relationship with a client, or an individual with whom the client has a close personal relationship.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Sexual Misconduct."> <paragraph num="A."> <text>The certified residential child care program administrator or certified residential child and youth care practitioner may not engage in sexual misconduct with a client or supervisee. Sexual misconduct includes but is not limited to:</text> <paragraph num="(1)"> <text>Inappropriate sexual language;</text> </paragraph> <paragraph num="(2)"> <text>Sexual exploitation;</text> </paragraph> <paragraph num="(3)"> <text>Sexual harassment;</text> </paragraph> <paragraph num="(4)"> <text>Sexual behavior; and</text> </paragraph> <paragraph num="(5)"> <text>Deception in the practice of residential care administration.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Sexual Relationships. The certified residential child care program administrator or certified residential child and youth care practitioner may not engage in either consensual or forced sexual behavior with:</text> <paragraph num="(1)"> <text>A client;</text> </paragraph> <paragraph num="(2)"> <text>A supervisee over whom the certified residential child care program administrator or certified residential child and youth care practitioner exercises professional authority or with whom the licensee maintains direct supervision or education while the professional relationship continues or exist; or</text> </paragraph> <paragraph num="(3)"> <text>An individual with whom the client has a close personal relationship, including but not limited to a relative or a significant individual in the client's life if there is a risk of exploitation or potential harm to the client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Sexual Harassment.</text> <paragraph num="(1)"> <text>The certified program administrator or certified residential child and youth care practitioner may not sexually harass a client or supervisee.</text> </paragraph> <paragraph num="(2)"> <text>If sexually harassed by a client, the certified program administrator or certified residential child and youth care practitioner shall comply with the provider agency incident reporting process as required under COMAR 14.31.06.18A(2).</text> </paragraph> </paragraph> <paragraph num="D."> <text>Deceit When Providing Residential Child Care Administration. The certified residential child care program administrator or certified residential child and youth care practitioner may not:</text> <paragraph num="(1)"> <text>Engage in sexual activity with a client or an individual in a close personal relationship with the client, on the pretense of therapeutic intent or benefit;</text> </paragraph> <paragraph num="(2)"> <text>Represent to the client or individual in close personal contact with the client that sexual contact or activity by or with the certified residential child care program administrator or certified residential child and youth care practitioner is consistent with or part of the client's care; or</text> </paragraph> <paragraph num="(3)"> <text>Suggest, recommend, or encourage the client to engage in a sexually provocative act, including but not limited to:</text> <paragraph num="(a)"> <text>Sexual contact with the certified residential child care program administrator or certified residential child and youth care practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Genital stimulation by or of the client or certified residential child care program administrator or certified residential child and youth care practitioner;</text> </paragraph> <paragraph num="(c)"> <text>Undressing by or of the certified program administrator or certified residential child and youth care practitioner in the presence of the client, or of the client in the presence of the certified residential child program administrator or certified residential child and youth care practitioner; or</text> </paragraph> <paragraph num="(d)"> <text>Discussion or disclosure of a sexually provocative or erotic nature, not necessitated by residential child care administration protocol.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Physical Contact."> <text>The certified residential child care program administrator or certified residential child and youth care practitioner engaging in physical contact with a client as an accepted component of a professionally recognized, nontraditional treatment modality shall have documented in the client's record by a licensed or certified health care professional:</text> <paragraph num="A."> <text>An assessment of the client;</text> </paragraph> <paragraph num="B."> <text>A written rationale for the use of the treatment modality for the client; and</text> </paragraph> <paragraph num="C."> <text>A copy of the informed consent, signed and dated by the client and the licensed or certified health care professional, which addresses:</text> <paragraph num="(1)"> <text>The risks and benefits of the treatment modality;</text> </paragraph> <paragraph num="(2)"> <text>The objective or objectives and intended outcome or outcomes of the proposed treatment;</text> </paragraph> <paragraph num="(3)"> <text>Available alternative interventions; and</text> </paragraph> <paragraph num="(4)"> <text>A description of the physical contact which may be reasonably anticipated by the client in the course of the proposed treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions."> <paragraph num="A."> <text>A certified residential child care program administrator or certified residential child and youth care practitioner is subject to sanctions if the certified residential child care program administrator or certified residential child and youth care practitioner:</text> <paragraph num="(1)"> <text>Has engaged in sexual misconduct with a client or supervisee;</text> </paragraph> <paragraph num="(2)"> <text>Has engaged in sexual behavior that would be considered unethical or unprofessional according to the professional standards of conduct, including but not limited to:</text> <paragraph num="(a)"> <text>Sexual behavior or knowledge of sexual behavior with a client placed in the residential child care program;</text> </paragraph> <paragraph num="(b)"> <text>Solicitation of a sexual relationship with a client placed in the residential child care program;</text> </paragraph> <paragraph num="(c)"> <text>Sexual advances, requesting sexual favors, or both;</text> </paragraph> <paragraph num="(d)"> <text>A verbal comment of a sexual nature;</text> </paragraph> <paragraph num="(e)"> <text>Physical contact of a sexual nature with a client placed in the residential child care program;</text> </paragraph> <paragraph num="(f)"> <text>Discussion of unnecessary sexual matters with a client placed in the residential child care program;</text> </paragraph> <paragraph num="(g)"> <text>Direct or indirect observation of a client while the client is undressing or dressing;</text> </paragraph> <paragraph num="(h)"> <text>The taking of photographs of a client placed in the residential child care program for a sexual purpose;</text> </paragraph> <paragraph num="(i)"> <text>Sexual harassment of staff, students, or volunteers;</text> </paragraph> <paragraph num="(j)"> <text>Sexual contact with a client placed in the residential child care program; or</text> </paragraph> <paragraph num="(k)"> <text>Offering to provide services, such as drugs, in exchange for sexual favors;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Has violated any of the provisions of the:</text> <paragraph num="(a)"> <text>Law pertaining to the certification of residential child care program administrators or residential child and youth care practitioners; or</text> </paragraph> <paragraph num="(b)"> <text>Regulations of the Board pertaining to the certification of residential child care program administrators or residential child and youth care practitioners;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Has violated any of the provisions of the law or regulations of the certification, supervising authority, or agency of the State or political subdivision of the State having jurisdiction of the operation, licensure, or certification of residential child care programs;</text> </paragraph> <paragraph num="(5)"> <text>Is professionally, physically, or mentally incompetent to act as a residential child care program administrator or residential child and youth care practitioner;</text> </paragraph> <paragraph num="(6)"> <text>Has practiced fraud, deceit, or misrepresentation in the capacity as a residential child care program administrator or residential child and youth care practitioner;</text> </paragraph> <paragraph num="(7)"> <text>Has wrongfully transferred or surrendered possession, either temporarily or permanently, of their certificate card to any other individual;</text> </paragraph> <paragraph num="(8)"> <text>Has used fraudulent, misleading, or deceptive advertising;</text> </paragraph> <paragraph num="(9)"> <text>Has endangered or sanctioned the endangerment of the safety, health, and life of any client;</text> </paragraph> <paragraph num="(10)"> <text>Has willfully permitted unauthorized disclosure of information relating to a client's records;</text> </paragraph> <paragraph num="(11)"> <text>Has discriminated in respect to clients placed in the residential child care program, employees, or staff on account of race, religion, color, national origin, disability, gender, sexual orientation, or any other area that the Board deems inappropriate; or</text> </paragraph> <paragraph num="(12)"> <text>Has practiced as a residential child care program administrator or residential child and youth care practitioner without holding a certificate to practice in the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A sanction constitutes the minimum disciplinary measure and does not preclude the Board from imposing additional penalties as it deems appropriate to an individual case.</text> </paragraph> <paragraph num="C."> <text>The Board shall advise all applicable licensing authorities of the suspension or revocation of a certificate on the grounds of sexual misconduct.</text> </paragraph> <paragraph num="D."> <text>The certified residential child care program administrator or certified residential child and youth care practitioner may not prohibit the client from reporting sexual misconduct as a condition of settlement of a legal cause of action.</text> </paragraph> <paragraph num="E."> <text>The Board may deny certification to any applicant, suspend or revoke a certification of a residential child care program administrator or a residential child and youth care practitioner, or reprimand or otherwise discipline a residential child care program administrator or a residential child and youth care practitioner after due notice and an opportunity to be heard at a formal hearing, upon evidence that the applicant, child care program administrator, or residential child and youth care practitioner has violated this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rehearings."> <paragraph num="A."> <text>A party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on him of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it stays the enforcement of the order, or excuses the individual affected for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeals."> <text>An individual whose certificate has been revoked or suspended by the Board, or any individual placed on probation or reprimand under this chapter, may appeal the Board's decision as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 20-205, and 20-213, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.57.04 to COMAR 10.57.05 effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> </annotations> </chapter> <chapter num="06" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the:</text> <paragraph num="(1)"> <text>Date, time, and place of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Except as provided in §C of this regulation, issues or charges involved in the proceeding.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Service upon a party shall be by delivery of the charging document and copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> <paragraph num="C."> <text>If by reason of the nature of the proceeding the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issues is necessary, the issues or charges shall be fully stated as soon as practicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Representation of Parties."> <text>Each party appearing at formal hearings shall have the right to appear in proper person or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Prehearing Procedures."> <paragraph num="A."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §A(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than as listed in §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(a)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this chapter shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In the event of a conflict between this and COMAR 28.02.01, this chapter applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Prehearing Conferences. The Board may set prehearing conferences as it considers appropriate.</text> </paragraph> <paragraph num="C."> <text>Oaths and Subpoenas.</text> <paragraph num="(1)"> <text>The Board may administer oaths and compel the attendance of witnesses and the production of physical evidence before it from witnesses upon whom process is served anywhere within the State as in civil cases in the circuit court of the county or of Baltimore city, by subpoena issued over the signature of an officer or the executive secretary of the Board.</text> </paragraph> <paragraph num="(2)"> <text>Upon a request by a party and statement under oath that the testimony or evidence is necessary to the party's defense, the Board shall issue a subpoena on the party's behalf.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Motions.</text> <paragraph num="(1)"> <text>Motions filed by a party shall be:</text> <paragraph num="(a)"> <text>Accompanied by a memorandum of points and authorities; and</text> </paragraph> <paragraph num="(b)"> <text>Filed with the Board at least 10 working days before the hearing and a copy served on the opposing party.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any response shall be filed with the Board at least 5 working days before the hearing and a copy shall be served on the opposing party.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Board Majority. Each hearing shall be held before not less than a quorum of the Board unless the hearing authority is delegated pursuant to State Government Article, §10-207, Annotated Code of Maryland. A delegation of authority shall be subject to the provisions of State Government Article, §10-212, Annotated Code of Maryland. Board action shall be by majority vote of those Board members present at the hearing.</text> </paragraph> <paragraph num="B."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The Chairman, or in the Chairman's absence a member designated by the Chairman, shall be the presiding officer, or if in a delegated hearing, a hearing examiner shall be the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Admit evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence; and</text> </paragraph> <paragraph num="(e)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall be responsible for decorum in hearings and may suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board.</text> </paragraph> <paragraph num="(2)"> <text>The member of the Office of the Attorney General presenting the case on behalf of the Board shall have all of the following rights:</text> <paragraph num="(a)"> <text>The submission of evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>Filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Order of Procedure. The State shall present its case first. Then the respondent shall present the respondent's case. After this the State may present rebuttal.</text> </paragraph> <paragraph num="E."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Each party has the right to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine witnesses called by the Board or other party; and</text> </paragraph> <paragraph num="(c)"> <text>Present summation and argument and file objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a party is represented by counsel, the submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by this counsel.</text> </paragraph> <paragraph num="(4)"> <text>Witnesses.</text> <paragraph num="(a)"> <text>The presiding officer, or any individual designated by the presiding officer for the purpose, may examine any witness called to testify.</text> </paragraph> <paragraph num="(b)"> <text>The presiding officer may call as a witness any individual in attendance at the hearing.</text> </paragraph> <paragraph num="(c)"> <text>Any member of the Board may examine any witness called to testify.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimonies, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed unless requested by a party or by the Board. The cost of any typewritten transcripts of any proceedings or part of them shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Decision and Order."> <paragraph num="A."> <text>Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law.</text> </paragraph> <paragraph num="B."> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or attorney of record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Rehearings."> <paragraph num="A."> <text>A party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on him of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it stays the enforcement of the order, or excuses the individual affected for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeals."> <text>An individual whose certificate has been revoked or suspended by the Board, or any individual placed on probation or reprimand under this chapter, may appeal the Board's decision as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§20-205 and 20-314; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.57.05 to COMAR 10.57.06 effective April 19, 2010 (37:8 Md. R. 617)</annotation> </annotations> </chapter> <chapter num="07" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Fee Schedule."> <text>The following fees are established by the Board:</text> <paragraph num="A."> <text>Residential Child Care Program Administrators:</text> <paragraph num="(1)"> <text>The Board shall prorate the initial application fee for applicants who apply for initial certification in the following manner:</text> <paragraph num="(a)"> <text>Within 2 years to 18 months of the renewal date . . . $200;</text> </paragraph> <paragraph num="(b)"> <text>Within 18 months to 1 year of the renewal date . . . $150;</text> </paragraph> <paragraph num="(c)"> <text>Within 1 year to 6 months of the renewal date . . . $100; and</text> </paragraph> <paragraph num="(d)"> <text>Within 6 months of the renewal date . . . $50;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>State Comprehensive Examination (charged each time an applicant takes the examination) . . . $125;</text> </paragraph> <paragraph num="(3)"> <text>Biennial Certificate Renewal . . . $200;</text> </paragraph> <paragraph num="(4)"> <text>Reinstatement Fee . . . $200;</text> </paragraph> <paragraph num="(5)"> <text>Acting Capacity Approval—$75; and</text> </paragraph> <paragraph num="(6)"> <text>Authorization to serve as the residential child care program administrator for 2 individually licensed organizations—$100;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Residential Child and Youth Care Practitioner:</text> <paragraph num="(1)"> <text>Initial Application . . . $50;</text> </paragraph> <paragraph num="(2)"> <text>Biennial Certificate Renewal—$ 50; and</text> </paragraph> <paragraph num="(3)"> <text>Reinstatement Fee . . . $50;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Other Fees:</text> <paragraph num="(1)"> <text>Application for approval of a continuing education program of studies . . . $100;</text> </paragraph> <paragraph num="(2)"> <text>Fine for failure to notify the Board within 30 days of a change in the:</text> <paragraph num="(a)"> <text>Name of the certificate holder;</text> </paragraph> <paragraph num="(b)"> <text>Home address of the certificate holder;</text> </paragraph> <paragraph num="(c)"> <text>Electronic mail address of the certificate holder; or</text> </paragraph> <paragraph num="(d)"> <text>Name or address of employer or business connection of the certificate holder . . . $50;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Returned check fee . . . $25;</text> </paragraph> <paragraph num="(4)"> <text>Diskettes, Labels or Rosters of Certified Individuals. Persons may purchase diskettes, labels, or rosters of certified:</text> <paragraph num="(a)"> <text>Residential Child Care Program Administrators . . . $50; or</text> </paragraph> <paragraph num="(b)"> <text>Residential Child and Youth Care Practitioner . . . $100;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Written verification of certification . . . $15;</text> </paragraph> <paragraph num="(6)"> <text>Failure to appear at Standards Examination without justification . . . $15; and</text> </paragraph> <paragraph num="(7)"> <text>Missing documentation reprocessing fee . . . $5.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Refunds."> <text>Fees are nonrefundable and nontransferable.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §20-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised and recodified from COMAR 10.57.06 to COMAR 10.57.07 effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 13, 2025 (52:20 Md. R. 1002)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective March 3, 2014 (41:4 Md. R. 302)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A, B amended effective September 14, 2015 (42:18 Md. R. 1175)</annotation> </annotations> </chapter> <chapter num="08" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <paragraph num="A."> <text>A custodian may disclose information in a certification or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure.</text> </paragraph> <paragraph num="B."> <text>A custodian may find that a compelling public purpose warrants disclosure of information in a certification or investigative file, whether or not there has been a request for the information, under the following circumstances:</text> <paragraph num="(1)"> <text>The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="(2)"> <text>The information concerns a possible regulatory violation and is disclosed to a federal, state, or local regulatory authority which has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to the possible regulatory violation by that individual; or</text> </paragraph> <paragraph num="(3)"> <text>The information concerns conduct by an individual which the custodian reasonably believes may pose a risk to the public health, safety, or welfare and is disclosed to a law enforcement authority, administrative official, or agency which regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §20-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.57.07 to COMAR 10.57.08 effective April 19, 2010 (37:8 Md. R. 617)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective April 19, 2010 (37:8 Md. R. 617)</annotation> </annotations> </chapter> <chapter num="09" heading="Tax Compliance Regulations"> <regulation prefix="Regulation" num=".01" heading="Outstanding Taxes or Unemployment Insurance Contributions."> <paragraph num="A."> <text>When a renewal applicant has been identified as delinquent by the Office of the Comptroller or the Maryland Department of Labor, the Board shall issue a written notice to the renewal applicant stating that:</text> <paragraph num="(1)"> <text>The renewal applicant has been identified by the Office of the Comptroller or the Maryland Department of Labor, as delinquent in the payment of taxes or unemployment insurance contributions as applicable; and</text> </paragraph> <paragraph num="(2)"> <text>The renewal certificate will be withheld until verification is received by the Board from the unit of the State responsible for collection of taxes or unemployment insurance contributions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Board does not receive a verification within 60 days after the expiration date of the current certificate, the certificate holder may be considered for reinstatement under Health Occupations Article, §20-311, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-213 and 20-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective January 7, 2008 (35:9 Md. R. 894); adopted permanently effective April 7, 2008 (35:7 Md. R. 749)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.57.08 to COMAR 10.57.09 effective April 19, 2010 (37:8 Md. R. 617)</annotation> </annotations> </chapter> <chapter num="10" heading="Disciplinary Sanctions and Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of disciplinary sanctions, not exceeding the maximum provided pursuant to Health Occupations Article, §20-405, Annotate Code of Maryland, against any residential child care program administrator or residential child and youth care practitioner in the state if, after a hearing or by consent after the right to a hearing has been waived, the Board finds that there are grounds under Health Occupations Article, §20-313, Annotate Code of Maryland, to deny a certificate to any applicant, reprimand a certificate holder, place a certificate holder on probation, suspend or revoke a certificate, or impose a fine or a term of imprisonment against a certificate holder under Health Occupations Article, §20-405, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board for the Certification of Residential Child Care Program Professionals.</text> </paragraph> <paragraph num="(2)"> <text>“Certificate” means a certificate issued by the Board to practice as a residential child care program administrator or a residential child and youth care practitioner.</text> </paragraph> <paragraph num="(3)"> <text>“Sanction” means a formal disciplinary action reprimanding, restricting, suspending, or revoking a certificate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Imposition of a Penalty — General."> <paragraph num="A."> <text>Imposition of a Penalty After a Hearing. If, after a hearing under Health Occupations Article, §20-313, Annotated Code of Maryland, and subject to the guidelines set forth in this subtitle, the Board finds that there are grounds under Health Occupations Article, §20-313, Annotated Code of Maryland, to reprimand or suspend or revoke a certificate, the Board may impose a penalty as set forth in this chapter:</text> <paragraph num="(1)"> <text>Instead of, or in addition to, reprimanding the certificate holder; or</text> </paragraph> <paragraph num="(2)"> <text>In addition to revoking the certificate.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Imposition of a Penalty Without a Hearing. If, after disciplinary procedures have been brought against a certified residential child care program administrator or a certified residential child and youth care practitioner, the certified residential child care program administrator or certified residential child and youth care practitioner waives the right to a hearing required under State Government Article, Title 10, Annotated Code of Maryland, and subject to the guidelines set forth in this subtitle, if the Board finds that there are grounds under Health Occupations Article, §20-313, Annotated Code of Maryland, to reprimand the certified residential child care program administrator or certified residential child and youth care practitioner, place the certificate on probation, or suspend or revoke a certificate, the Board may impose a penalty for each violation in addition to reprimanding, placing the certificate on probation, or suspending or revoking the certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions or Imposition of a Penalty."> <paragraph num="A."> <text>Subject to the provisions of this section, the Board may impose the following sanctions and penalties for violations of the Maryland Certification of Residential Child Care Program Professionals Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories:</text> <paragraph num="(1)"> <text>Fraudulently or Deceptively Obtains, Attempts to Obtain a Certificate.</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or Deceptively Uses a Certificate.</text> </paragraph> <paragraph num="(3)"> <text>Criminal Convictions or Nolo Contendere.(whether or not any appeal or other proceeding is pending to have the conviction set aside).</text> </paragraph> <paragraph num="(4)"> <text>Impairment (mentally, physically, or through the use of drugs or alcohol).</text> </paragraph> <paragraph num="(5)"> <text>Reciprocal Discipline.</text> </paragraph> <paragraph num="(6)"> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="(7)"> <text>Willfully Makes or Files a False Report, Willfully Fails, Obstructs the Filing, or Induces Another to Fail to File or Record a Report as Required by Law.</text> </paragraph> <paragraph num="(8)"> <text>Unprofessional Conduct in Performing Duties.</text> </paragraph> <paragraph num="(9)"> <text>Discrimination.</text> </paragraph> <paragraph num="(10)"> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="(11)"> <text>Continuing Education Violations.</text> </paragraph> <paragraph num="(12)"> <text>Failure to Cooperate.</text> </paragraph> <paragraph num="(13)"> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="(14)"> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="(15)"> <text>Other Violations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a certified residential child care program administrator or residential child and youth care practitioner is found in violation of more than one category enumerated in this chapter, the category or categories containing the highest maximum sanction shall control.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors to be Considered in the Assessment of a Sanction."> <text>Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to:</text> <paragraph num="A."> <text>Mitigating Factors:</text> <paragraph num="(1)"> <text>The certified residential child care program administrator or residential child and youth care practitioner’s lack of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The certified residential child care program administrator or residential child and youth care practitioner’s self-report violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The certified residential child care program administrator or residential child and youth care practitioner’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of remedial measures to correct or mitigate harm arising from misconduct;</text> </paragraph> <paragraph num="(5)"> <text>Timely good-faith effort to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(6)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>Absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>Absence of potential harm to public or adverse impact; and,</text> </paragraph> <paragraph num="(9)"> <text>The certified residential child care program administrator or residential child and youth care practitioner’s conduct was an isolated incident and not likely to recur.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Aggravating Factors:</text> <paragraph num="(1)"> <text>The certified residential child care program administrator or residential child and youth care practitioner’s has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation has the potential for, or caused, serious client harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The certified residential child care program administrator or residential child and youth care practitioner was motivated to perform the violation by his or her financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the client or clients;</text> </paragraph> <paragraph num="(7)"> <text>The certified residential child care program administrator or residential child and youth care practitioner attempted to hide error or misconduct from clients or others;</text> </paragraph> <paragraph num="(8)"> <text>The certified residential child care program administrator or residential child and youth care practitioner concealed, falsified, or destroyed evidence or presented false testimony or evidence;</text> </paragraph> <paragraph num="(9)"> <text>The certified residential child care program administrator or residential child and youth care practitioner failed to cooperate with the investigation;</text> </paragraph> <paragraph num="(10)"> <text>Previous attempts at rehabilitation of the certified residential child care program administrator or residential child and youth care practitioner were unsuccessful; and</text> </paragraph> <paragraph num="(11)"> <text>The certified residential child care program administrator or residential child and youth care practitioner committed the violation under the guise of treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> </paragraph> <paragraph num="D."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 20-313, and 20-405, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 11, 2012 (39:11 Md. R. 688)</annotation> </annotations> </chapter> </subtitle> <subtitle num="58" heading="Board of Professional Counselors and Therapists"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Applies to graduate and clinical professional counselors, graduate and clinical marriage and family therapists, graduate and clinical art therapists, graduate, clinical, and certified alcohol and drug counselors, and alcohol and drug trainees in Maryland; and</text> </paragraph> <paragraph num="B."> <text>Does not supersede the regulations set forth under:</text> <paragraph num="(1)"> <text>COMAR 10.58.07;</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.58.08;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 10.58.12; and</text> </paragraph> <paragraph num="(4)"> <text>COMAR 10.58.17.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Certificate” means a certificate issued by the Board to practice:</text> <paragraph num="(a)"> <text>Certified associate counseling — alcohol and drug (CAC—AD);</text> </paragraph> <paragraph num="(b)"> <text>Certified professional counseling (CPC);</text> </paragraph> <paragraph num="(c)"> <text>Certified professional counseling — alcohol and drug (CPC—AD);</text> </paragraph> <paragraph num="(d)"> <text>Certified professional counseling — marriage and family therapy (CPC—MFT); or</text> </paragraph> <paragraph num="(e)"> <text>Certified supervised counseling — alcohol and drug (CSC—AD).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Credit hour” means attendance in class for a minimum of 12 hours per semester or 18 hours per quarter, resulting in a grade which is earned, not audited, from an accredited educational institution approved by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“License” means a license issued by the Board to practice:</text> <paragraph num="(a)"> <text>Clinical alcohol and drug counseling (LCADC);</text> </paragraph> <paragraph num="(b)"> <text>Clinical marriage and family therapy (LCMFT);</text> </paragraph> <paragraph num="(c)"> <text>Clinical professional counseling (LCPC);</text> </paragraph> <paragraph num="(d)"> <text>Clinical professional art therapy (LCPAT);</text> </paragraph> <paragraph num="(e)"> <text>Graduate alcohol and drug counseling (LGADC);</text> </paragraph> <paragraph num="(f)"> <text>Graduate marriage and family therapy counseling (LGMFT); [or]</text> </paragraph> <paragraph num="(g)"> <text>Graduate professional counseling (LGPC); or</text> </paragraph> <paragraph num="(h)"> <text>Graduate professional art therapy (LGPAT).</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="General."> <paragraph num="A."> <text>Unless certified, licensed, or granted trainee status by the Board, an individual may not use:</text> <paragraph num="(1)"> <text>The title alcohol and drug trainee (ADT); or</text> </paragraph> <paragraph num="(2)"> <text>Any other:</text> <paragraph num="(a)"> <text>Title;</text> </paragraph> <paragraph num="(b)"> <text>Initials;</text> </paragraph> <paragraph num="(c)"> <text>Abbreviations;</text> </paragraph> <paragraph num="(d)"> <text>Representation; or</text> </paragraph> <paragraph num="(e)"> <text>Description as specified under Health Occupations Article, §§17-601—17-603, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An individual who violates this regulation may be subject to sanctions pursuant to Health Occupations Article, §§17-513 and 17-604, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application Process."> <paragraph num="A."> <text>In order to obtain a certificate or license, an applicant shall:</text> <paragraph num="(1)"> <text>Complete and return the Board-approved application;</text> </paragraph> <paragraph num="(2)"> <text>Except for out-of-state Marriage and Family Therapist applicants, submit an official transcript from an accredited educational institution awarding the highest degree attained in counseling or a related field;</text> </paragraph> <paragraph num="(3)"> <text>Pay all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(4)"> <text>Provide at least three references from persons familiar with the work of the applicant;</text> </paragraph> <paragraph num="(5)"> <text>Submit to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(7)"> <text>Be at least 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applications shall be acted upon as follows:</text> <paragraph num="(1)"> <text>Within 30 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice, the applicant shall correct the deficiency within 90 days, or other period specified in the notice;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the Board determines that an applicant is eligible to take the required examinations, the Board shall send a notice of approval to the applicant;</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of the approval notice, the applicant shall have 1 year from the date of the notice to take the examinations; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant fails to take the examinations within 1 year from the date of the approval notice, the requirements set forth under §B(4) of this regulation shall apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reexamination."> <text>An applicant who fails an examination for certification or licensure:</text> <paragraph num="A."> <text>May retake the exam if:</text> <paragraph num="(1)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(2)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="B."> <text>Shall be required to:</text> <paragraph num="(1)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(2)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Certification and Licensure."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Issue a certificate or license number to an applicant who has met the requirements as set forth under this subtitle; and</text> </paragraph> <paragraph num="(2)"> <text>Provide licensure, certification, or trainee status verification:</text> <paragraph num="(a)"> <text>On the Board's website; and</text> </paragraph> <paragraph num="(b)"> <text>From the Board's office.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal — Certified Professional Counselor.</text> <paragraph num="(1)"> <text>To renew as a certified professional counselor, the applicant shall:</text> <paragraph num="(a)"> <text>Complete a Board-approved renewal application;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required application fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not:</text> <paragraph num="(a)"> <text>Renew the certification of any certified professional counselor who fails to complete all requirements for renewal before the expiration date of the current certification; or</text> </paragraph> <paragraph num="(b)"> <text>Reinstate the certification of a certified professional counselor who has failed to renew for any reason.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-101, 17-205, 17-301, 17-304, 17-307, 17-308, and 17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 10, 1989 (16:13 Md. R. 1422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 26, 1996 (23:17 Md. R. 1248); July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 26, 1996 (23:17 Md. R. 1248); September 22, 1997 (24:19 Md. R. 1340); July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 26, 1996 (23:17 Md. R. 1248); July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 26, 1996 (23:17 Md. R. 1248); July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation .05 adopted effective September 22, 1997 (24:19 Md. R. 1340)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 26, 1996 (23:17 Md. R. 1248); July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09C adopted effective August 26, 1996 (23:17 Md. R. 1248)</annotation> <annotation type="History" subtype="Administrative History">Regulations .10—.13 adopted effective July 26, 1999 (26:15 Md. R. 1155)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); revised permanently effective January 21, 2002 (29:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); amended permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 23, 2006 (33:23 Md. R. 1796)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1246)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); adopted permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 14, 2025 (52:23 Md. R. 1140)</annotation> </annotations> </chapter> <chapter num="02" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>A person shall pay a fee as set forth in Regulation .02, of this chapter, by certified check or money order.</text> </paragraph> <paragraph num="B."> <text>The Board shall provide a copy of this chapter:</text> <paragraph num="(1)"> <text>Along with any application form or renewal form; and</text> </paragraph> <paragraph num="(2)"> <text>To any other person upon request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not refund a fee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fee Schedule."> <text>The following fees are established by the Board for items or services provided under this subtitle:</text> <paragraph num="A."> <text>Application processing fee:</text> <paragraph num="(1)"> <text>For certificate and trainee status ... $150; or</text> </paragraph> <paragraph num="(2)"> <text>For licensure ... $250;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Subsequent application review fee ... $50;</text> </paragraph> <paragraph num="C."> <text>Preapplication credentials evaluation fee ... $50;</text> </paragraph> <paragraph num="D."> <text>Certification fee ... $100;</text> </paragraph> <paragraph num="E."> <text>Licensure fee ... $200;</text> </paragraph> <paragraph num="F."> <text>Certification and trainee renewal fee ... $200;</text> </paragraph> <paragraph num="G."> <text>Licensure renewal fee ... $275;</text> </paragraph> <paragraph num="H."> <text>Late renewal fee (in addition to §F or G of this regulation) ... $50;</text> </paragraph> <paragraph num="I."> <text>Certification and licensure verification ... $20;</text> </paragraph> <paragraph num="J."> <text>Duplicate or replacement certificate or license ... $15;</text> </paragraph> <paragraph num="K."> <text>Endorsement to another jurisdiction ... $10;</text> </paragraph> <paragraph num="L."> <text>Name or address change ... No fee;</text> </paragraph> <paragraph num="M."> <text>Inactive status (annual) ... $50;</text> </paragraph> <paragraph num="N."> <text>Reinstatement fee:</text> <paragraph num="(1)"> <text>For certificate ... $150;</text> </paragraph> <paragraph num="(2)"> <text>For license ... $200;</text> </paragraph> </paragraph> <paragraph num="O."> <text>2-year sponsorship of continuing education programs:</text> <paragraph num="(1)"> <text>For organization ... $750;</text> </paragraph> <paragraph num="(2)"> <text>For individual ... $300; or</text> </paragraph> <paragraph num="(3)"> <text>For an individual workshop ... $150;</text> </paragraph> </paragraph> <paragraph num="P."> <text>Review for non-preapproved CEUs for individuals (per occurrence) ... $15;</text> </paragraph> <paragraph num="Q."> <text>Drug and alcohol certification upgrade fee ... $25;</text> </paragraph> <paragraph num="R."> <text>Returned check fee ... $25;</text> </paragraph> <paragraph num="S."> <text>Failure to notify of change of address ... $25;</text> </paragraph> <paragraph num="T."> <text>Copy and scanning fee ... $2 per page; and</text> </paragraph> <paragraph num="U."> <text>Out-of-State application processing fee ... $250.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-205, 17-206, and 17-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 10, 1989 (16:13 Md. R. 1422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 8, 1992 (19:11 Md. R. 1016); April 3, 2000 (27:6 Md. R. 642); September 28, 2015 (42:19 Md. R. 1228)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective March 18, 1993 (19:21 Md. R. 1892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02M, N amended effective January 2, 1994 (20:26 Md. R. 2028)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, D, E amended effective March 14, 1994 (21:5 Md. R. 404)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to an individual certified or licensed by the Board of Professional Counselors and Therapists.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Professional Counselors and Therapists.</text> </paragraph> <paragraph num="(2)"> <text>Client.</text> <paragraph num="(a)"> <text>“Client” means an individual, couple, family, group, business, agency, school, organization, or association to whom a counselor is rendering professional service.</text> </paragraph> <paragraph num="(b)"> <text>“Client” includes the term and concept of “patient”.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Counselor” means a counselor or therapist either certified or licensed by the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Dual relationship” means a relationship in which a counselor is simultaneously involved in more than one type of relationship with a client.</text> </paragraph> <paragraph num="(5)"> <text>“Impaired counselor” means a counselor who cannot perform the counselor's job due to substance abuse, or psychological or physical illness.</text> </paragraph> <paragraph num="(6)"> <text>“Inappropriate sexual language” means:</text> <paragraph num="(a)"> <text>A sexualized harassing comment;</text> </paragraph> <paragraph num="(b)"> <text>An eroticized or sexually provocative comment not reasonably associated with a health care matter; or</text> </paragraph> <paragraph num="(c)"> <text>An inappropriate discussion of a sexually related matter.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Public statements” include, but are not limited to, communications or public announcements by a newspaper, magazine, book list, directory, television, radio, motion picture, advertisement, or any other electronic means.</text> </paragraph> <paragraph num="(8)"> <text>“Sexual behavior” means:</text> <paragraph num="(a)"> <text>A “sexual act” as defined in Criminal Law Article, §3-301, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>“Sexual contact” as defined in Criminal Law Article, §3-301, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>“Vaginal intercourse” as defined in Criminal Law Article, §3-301, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Sexual exploitation” means a counselor taking advantage of an unequal relationship between a counselor and a client, student, or supervisee, and not permitting the autonomy of a client, student, or supervisee.</text> </paragraph> <paragraph num="(10)"> <text>“Sexual harassment” means a deliberate or repeated comment, advance, gesture, solicitation, request, or physical contact of a sexual nature.</text> </paragraph> <paragraph num="(11)"> <text>“Supervisee” means an individual to whom a counselor provides professional, educational, or administrative supervision or direction.</text> </paragraph> <paragraph num="(12)"> <text>“Therapeutic deception” means a representation by a counselor that sexual contact or sexual activity by or with a client is consistent with or part of a client's treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Professional Competence."> <paragraph num="A."> <text>A counselor shall:</text> <paragraph num="(1)"> <text>Practice only within the boundaries of a counselor's competence, based on education, training, supervised experience, and professional credentials;</text> </paragraph> <paragraph num="(2)"> <text>When developing competence in a new service or technique, or both, engage in ongoing consultation with other counselors or relevant professionals and acquire appropriate additional education or training, or both, in the new area; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain qualifications to practice counseling, including meeting the continuing education requirements established by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An impaired counselor shall:</text> <paragraph num="(1)"> <text>Suspend, terminate, or limit professional activities if the counselor determines that he or she is unable to continue professional activities; or</text> </paragraph> <paragraph num="(2)"> <text>Seek competent professional assistance to determine whether to suspend, terminate, or limit the scope of professional or scientific activities if a counselor becomes or is made aware that personal problems interfere with providing or conducting counseling or therapy services.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Ethical Responsibility."> <paragraph num="A."> <text>A counselor shall:</text> <paragraph num="(1)"> <text>Consult with other counselors or other relevant professionals regarding questions related to ethical obligations or professional practice;</text> </paragraph> <paragraph num="(2)"> <text>Take credit only for professional work actually performed;</text> </paragraph> <paragraph num="(3)"> <text>Notify the Board if the counselor's license, or certificate, or both, has been limited, restricted, suspended, revoked, or subject to disciplinary action by any other state, federal agency, or the District of Columbia;</text> </paragraph> <paragraph num="(4)"> <text>Disclose, to all involved, conflicts of interest regarding confidentiality requirements;</text> </paragraph> <paragraph num="(5)"> <text>Receive appropriate written authorization to provide counseling services for minors or other clients unable to give informed consent;</text> </paragraph> <paragraph num="(6)"> <text>Protect the interests of minors or other clients unable to give informed consent;</text> </paragraph> <paragraph num="(7)"> <text>Maintain accurate records;</text> </paragraph> <paragraph num="(8)"> <text>Provide supervision to supervisees as required under COMAR 10.58.01, 10.58.07, and 10.58.08;</text> </paragraph> <paragraph num="(9)"> <text>Make arrangements for another appropriate professional to act in the event of an absence of the counselor;</text> </paragraph> <paragraph num="(10)"> <text>Provide lawfully requested treatment reports or evaluations, or both, to a client, insurance carriers, courts systems, institutions, or other authorized persons;</text> </paragraph> <paragraph num="(11)"> <text>Be familiar with and adhere to this chapter;</text> </paragraph> <paragraph num="(12)"> <text>Report suspected violations of Health Occupations Article, Title 17, Annotated Code of Maryland, to the Board;</text> </paragraph> <paragraph num="(13)"> <text>Cooperate with investigations, proceedings, and other requirements of the Board; and</text> </paragraph> <paragraph num="(14)"> <text>Take reasonable precautions to protect clients from physical or psychological trauma.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A counselor may not:</text> <paragraph num="(1)"> <text>Knowingly associate with, or permit the use of the professional counselor's name or firm name in a business venture by any person or firm which the professional counselor knows, or has reason to believe, is engaging in business or professional practices of a fraudulent or dishonest nature;</text> </paragraph> <paragraph num="(2)"> <text>Participate in dishonest, fraudulent, or deceitful activity in the capacity of a counselor; or</text> </paragraph> <paragraph num="(3)"> <text>Enter into relationships that could compromise a counselor's objectivity or create a conflict of interest.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A counselor involved in research shall:</text> <paragraph num="(1)"> <text>Respect and protect the dignity, privacy, and welfare of research subjects;</text> </paragraph> <paragraph num="(2)"> <text>Comply with existing federal and State laws and regulations concerning treatment of research subjects;</text> </paragraph> <paragraph num="(3)"> <text>Take responsibility for the ethical treatment of research participants by others directly and reasonably related to the research; and</text> </paragraph> <paragraph num="(4)"> <text>Clearly indicate to prospective recipients treatment given as part of a research study and obtain written permission in advance of treatment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="The Counseling Relationship."> <paragraph num="A."> <text>Client Welfare and Rights.</text> <paragraph num="(1)"> <text>A counselor shall:</text> <paragraph num="(a)"> <text>Inform clients of the purposes, goals, techniques, procedures, limitations, potential risks, and benefits of services to be performed;</text> </paragraph> <paragraph num="(b)"> <text>Explain to clients the implications of diagnosis, the intended use of tests and reports, fees, and billing arrangements;</text> </paragraph> <paragraph num="(c)"> <text>Document attempts to inform other professional persons concurrently providing mental health services to a client;</text> </paragraph> <paragraph num="(d)"> <text>Assist clients in making appropriate arrangements for the continuation of treatment due to interruptions including but not limited to vacations and extended illness; and</text> </paragraph> <paragraph num="(e)"> <text>Make appropriate referrals.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A counselor may not:</text> <paragraph num="(a)"> <text>Place or participate in placing clients in positions that may result in damaging the interests and the welfare of clients, employees, employers, or the public;</text> </paragraph> <paragraph num="(b)"> <text>Condone or engage in discrimination based on age, color, culture, disability, ethnic group, gender, race, religion, sexual orientation, marital status, or socioeconomic status;</text> </paragraph> <paragraph num="(c)"> <text>Abandon or neglect clients in counseling; or</text> </paragraph> <paragraph num="(d)"> <text>Foster dependent counseling relationships.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Dual Relationships.</text> <paragraph num="(1)"> <text>A counselor shall:</text> <paragraph num="(a)"> <text>Avoid dual relationships with clients; and</text> </paragraph> <paragraph num="(b)"> <text>Take appropriate measures, including but not limited to, informed consent, consultation, supervision, and documentation to ensure that judgment is not impaired and no exploitation occurs if a dual relationship cannot be avoided.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A counselor may not:</text> <paragraph num="(a)"> <text>Exploit trust and dependency in relationships with supervisees, employees, research participants, students, or volunteers; or</text> </paragraph> <paragraph num="(b)"> <text>Accept as clients superiors or subordinates with whom a counselor has administrative, supervisory, or evaluative relationships.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Multiple Clients.</text> <paragraph num="(1)"> <text>A counselor shall clarify the unit of treatment in a counselor's written records as:</text> <paragraph num="(a)"> <text>Individual;</text> </paragraph> <paragraph num="(b)"> <text>Couple;</text> </paragraph> <paragraph num="(c)"> <text>Family;</text> </paragraph> <paragraph num="(d)"> <text>Group; or</text> </paragraph> <paragraph num="(e)"> <text>Any combination of §C(1)(a)—(d) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A counselor shall identify in the written records individuals present in sessions, but not a part of the unit of treatment.</text> </paragraph> <paragraph num="(3)"> <text>A counselor shall communicate limitations on confidentiality to all clients.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Termination and Referral.</text> <paragraph num="(1)"> <text>Termination may occur if:</text> <paragraph num="(a)"> <text>Services are no longer requested by a client;</text> </paragraph> <paragraph num="(b)"> <text>Counseling no longer serves a client's needs or interests;</text> </paragraph> <paragraph num="(c)"> <text>A counselor is unable to competently and ethically perform duties;</text> </paragraph> <paragraph num="(d)"> <text>A client does not pay the fees charged; or</text> </paragraph> <paragraph num="(e)"> <text>Agency or institution limits do not allow further counseling services.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A counselor may terminate a counseling relationship only after:</text> <paragraph num="(a)"> <text>Securing a client's agreement; or</text> </paragraph> <paragraph num="(b)"> <text>If a client does not agree to termination, offering an appropriate referral.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Fees and Bartering."> <paragraph num="A."> <text>A counselor shall explain to a client, before entering the counseling relationship, all financial arrangements related to professional services including the use of collection agencies or legal measures for nonpayment.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §C of this regulation, a counselor may not accept goods or services instead of monetary payment.</text> </paragraph> <paragraph num="C."> <text>A counselor may accept goods or services instead of monetary payment only if:</text> <paragraph num="(1)"> <text>The relationship is not exploitative;</text> </paragraph> <paragraph num="(2)"> <text>The client requests it;</text> </paragraph> <paragraph num="(3)"> <text>A clear written contract is established; and</text> </paragraph> <paragraph num="(4)"> <text>The arrangements are an accepted practice among professionals in the community.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A counselor may not accept or give anything of value for receiving or making a referral.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Advertising, Public Statements, and Media Presentations."> <paragraph num="A."> <text>Advertising.</text> <paragraph num="(1)"> <text>A counselor may place advertisements with directories, newspapers, periodicals, radio or television stations, or on the internet.</text> </paragraph> <paragraph num="(2)"> <text>In placing advertisements or making other types of public statements, a counselor shall identify a counselor's credentials in a manner that is accurate and not false, misleading, deceptive, or fraudulent.</text> </paragraph> <paragraph num="(3)"> <text>A counselor may not place advertisements or make public statements that:</text> <paragraph num="(a)"> <text>Contain false, fraudulent, misleading, deceptive, or unfair statements or information;</text> </paragraph> <paragraph num="(b)"> <text>Contain partial disclosures of relevant facts that misrepresent, mislead, or deceive;</text> </paragraph> <paragraph num="(c)"> <text>Contain information or facts intended or likely to create false or unjustified expectations of favorable results;</text> </paragraph> <paragraph num="(d)"> <text>Misrepresent, either directly or by implication, a counselor's professional qualifications such as education, experience, or areas of competence;</text> </paragraph> <paragraph num="(e)"> <text>Misrepresent, either directly or by implication, a counselor's affiliations or the purposes or characteristics of institutions or organizations with which a counselor is affiliated;</text> </paragraph> <paragraph num="(f)"> <text>Contain representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or be deceived; or</text> </paragraph> <paragraph num="(g)"> <text>Contain representations that a counselor is willing to perform any procedure that is illegal under federal or State laws or regulations.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If advertising on the internet, a counselor shall ensure that the advertisement contains the counselor's name, credentials, and certificate or license number.</text> </paragraph> <paragraph num="(5)"> <text>In advertising products, workshops, or training events, a counselor shall:</text> <paragraph num="(a)"> <text>Comply with this section; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure that the information disclosed is adequate for consumers to make informed choices.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>A counselor holding a doctoral degree in a field other than counseling may not represent that doctoral degree as relating to status or practice as a counselor.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Public Statements.</text> <paragraph num="(1)"> <text>A counselor shall:</text> <paragraph num="(a)"> <text>Correct others who misrepresent a counselor's professional qualifications or affiliations;</text> </paragraph> <paragraph num="(b)"> <text>Abstain from soliciting testimonial endorsements from current clients or other persons who, because of particular circumstances, are vulnerable to undue influence;</text> </paragraph> <paragraph num="(c)"> <text>Abstain from engaging in uninvited, in-person solicitation of business from actual or potential clients or others who, because of particular circumstances, are vulnerable to undue influence; and</text> </paragraph> <paragraph num="(d)"> <text>In the capacity of teacher, ensure that statements in course outlines are accurate and not misleading, false, or deceptive, including statements regarding subject matter to be covered, the basis for evaluating progress, and the nature of the course experience.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A counselor may not:</text> <paragraph num="(a)"> <text>Use the counselor's place of employment or institutional affiliation to solicit or recruit clients, supervisees, or consultees for a counselor's private practice;</text> </paragraph> <paragraph num="(b)"> <text>Use counseling, teaching, training, or supervisory relationships:</text> <paragraph num="(i)"> <text>To promote a counselor's products or training events in a deceptive manner; or</text> </paragraph> <paragraph num="(ii)"> <text>On persons who, because of circumstances, may be vulnerable; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Claim organizational membership in a manner that suggests specialized competence, training, or qualifications that a counselor does not have.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Media Presentations. A counselor providing commentary or advice in a public lecture, presentation, demonstration, radio or television program, prerecorded electronic medium, printed article, mailed material, internet, or other medium, shall ensure that:</text> <paragraph num="(1)"> <text>Statements made are based on current and appropriate professional counseling literature and methodology;</text> </paragraph> <paragraph num="(2)"> <text>Recipients of the information are not mislead or encouraged to infer that a professional counseling relationship has been established; and</text> </paragraph> <paragraph num="(3)"> <text>Statements are in conformance with this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Records, Confidentiality, and Informed Consent."> <paragraph num="A."> <text>A counselor shall:</text> <paragraph num="(1)"> <text>Maintain the privacy and confidentiality of a client and a client's records;</text> </paragraph> <paragraph num="(2)"> <text>Release mental health records or information about a client only with a client's consent, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Release alcohol and substance abuse records or information about a client only with a client's consent, or as permitted by State and federal law;</text> </paragraph> <paragraph num="(4)"> <text>Dispose of records in accordance with Health-General Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Provide sufficient information to a client to allow a client to make an informed decision regarding treatment, including the following:</text> <paragraph num="(a)"> <text>The purpose and nature of an evaluation or treatment process;</text> </paragraph> <paragraph num="(b)"> <text>Additional options to the proposed treatment;</text> </paragraph> <paragraph num="(c)"> <text>Potential reactions to the proposed treatment;</text> </paragraph> <paragraph num="(d)"> <text>The estimated cost of treatment;</text> </paragraph> <paragraph num="(e)"> <text>The right of a client to withdraw from treatment at any time, including the possible risks that may be associated with withdrawal; and</text> </paragraph> <paragraph num="(f)"> <text>The right of a client to decline treatment, if part or all of the treatment is to be recorded for research or review by another person;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Obtain full informed consent of a client participating in a human research program; and</text> </paragraph> <paragraph num="(7)"> <text>Protect a client's autonomy and dignity to decide whether to participate in a human research program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A counselor may not imply that a penalty may result if a client refuses to participate in a human research program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Sexual Misconduct."> <paragraph num="A."> <text>A counselor may not engage in sexual misconduct with a client or supervisee. Sexual misconduct includes but is not limited to:</text> <paragraph num="(1)"> <text>Inappropriate sexual language;</text> </paragraph> <paragraph num="(2)"> <text>Sexual exploitation;</text> </paragraph> <paragraph num="(3)"> <text>Sexual harassment;</text> </paragraph> <paragraph num="(4)"> <text>Sexual behavior; and</text> </paragraph> <paragraph num="(5)"> <text>Therapeutic deception.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Concurrent Sexual Relationships. A counselor may not engage in either consensual or forced sexual behavior with:</text> <paragraph num="(1)"> <text>A client;</text> </paragraph> <paragraph num="(2)"> <text>A student or supervisee over whom the counselor exercises professional authority, or with whom the counselor maintains evaluative responsibility, supervision, or education, while the professional relationship continues to exist; or</text> </paragraph> <paragraph num="(3)"> <text>An individual with whom the client has a close personal relationship, including but not limited to a relative or significant individual in the client's life, if there is a risk of exploitation or potential harm to the client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Relationship with Former Clients.</text> <paragraph num="(1)"> <text>Except as set forth in §C(3) of this regulation, a counselor may not engage in sexual behavior with a former client.</text> </paragraph> <paragraph num="(2)"> <text>A counselor may not terminate professional services or a professional relationship with a client in order to enter into a nonprofessional, social, or sexual relationship with a client or an individual with whom a client has a close personal relationship.</text> </paragraph> <paragraph num="(3)"> <text>A counselor may enter into a relationship with an individual with whom a counselor's prior professional contact was brief, peripheral, consultative, or indirect, and did not constitute a therapeutic relationship.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prior Sexual Relationships. A counselor may not provide professional services to an individual with whom a counselor has previously engaged in sexual behavior.</text> </paragraph> <paragraph num="E."> <text>Sexual Harassment.</text> <paragraph num="(1)"> <text>A counselor may not sexually harass a:</text> <paragraph num="(a)"> <text>Client;</text> </paragraph> <paragraph num="(b)"> <text>Student;</text> </paragraph> <paragraph num="(c)"> <text>Supervisee; or</text> </paragraph> <paragraph num="(d)"> <text>Supervisor.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If sexually harassed by a client, a counselor shall:</text> <paragraph num="(a)"> <text>Seek professional consultation with another licensed health care professional;</text> </paragraph> <paragraph num="(b)"> <text>Redefine the professional plan of action in writing in a client's record, documenting all action taken in a client's treatment plan; and</text> </paragraph> <paragraph num="(c)"> <text>Terminate the relationship with the client and assist in a referral to another health care provider.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Therapeutic Deception. A counselor may not:</text> <paragraph num="(1)"> <text>Engage in sexual activity with a client or an individual in a close personal relationship with a client, on the pretense of therapeutic intent or benefit;</text> </paragraph> <paragraph num="(2)"> <text>Represent to a client or individual in close personal contact with a client that sexual contact or activity by or with a counselor is consistent with or part of a client's therapy; or</text> </paragraph> <paragraph num="(3)"> <text>Suggest, recommend, or encourage a client to engage in a sexually provocative act, including but not limited to:</text> <paragraph num="(a)"> <text>Sexual contact with a counselor;</text> </paragraph> <paragraph num="(b)"> <text>Genital stimulation by or of a client or counselor;</text> </paragraph> <paragraph num="(c)"> <text>Undressing, by or of a counselor in the presence of a client, or of a client in the presence of a counselor; and</text> </paragraph> <paragraph num="(d)"> <text>Discussion or disclosure of a sexually provocative or erotic nature, not necessitated by treatment or treatment protocol.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Physical Contact."> <paragraph num="A."> <text>A counselor engaging in nontraditional treatment modalities using physical contact with a client shall document in a client's record:</text> <paragraph num="(1)"> <text>An assessment of a client;</text> </paragraph> <paragraph num="(2)"> <text>A written rationale for the use of the physical contact treatment modality for a client; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the informed consent, signed and dated by the client and the counselor which addresses:</text> <paragraph num="(a)"> <text>The risks and benefits of the physical contact treatment modality;</text> </paragraph> <paragraph num="(b)"> <text>The objective or objectives and intended outcome or outcomes of the proposed treatment;</text> </paragraph> <paragraph num="(c)"> <text>Available alternative interventions; and</text> </paragraph> <paragraph num="(d)"> <text>A description of the physical contact which may be reasonably anticipated by a client in the course of the proposed treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A counselor may not engage in a treatment modality involving physical contact if the risk of psychological harm to a client, as a result of the physical contact, has been assessed by a counselor to outweigh the possible benefits of the treatment, independent of a client's wishes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Sanctions."> <paragraph num="A."> <text>A counselor who engages in sexual misconduct with a client or supervisee is subject to sanctions by the Board.</text> </paragraph> <paragraph num="B."> <text>A sanction constitutes the minimum disciplinary measure and does not preclude the Board from imposing additional penalties as it considers appropriate to an individual case.</text> </paragraph> <paragraph num="C."> <text>The Board shall advise professional associations of a reprimand, suspension, or revocation of a license or certificate on the grounds of sexual misconduct.</text> </paragraph> <paragraph num="D."> <text>A counselor may not prohibit a client from reporting sexual misconduct as a condition of settlement of a legal cause of action.</text> </paragraph> <paragraph num="E."> <text>A counselor who does not comply with this chapter shall be in violation of Health Occupations Article, §17-313, Annotated Code of Maryland, and subject to disciplinary actions.</text> </paragraph> <paragraph num="F."> <text>A lack of knowledge, or misunderstanding of an ethical responsibility, is not a defense against a charge of unethical conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212 and 17-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 10, 1989 (16:13 Md. R. 1422)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 3, 2000 (27:6 Md. R. 642)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 repealed and new Regulations .01—.11 adopted effective October 1, 2001 (28:19 Md. R. 1685)</annotation> </annotations> </chapter> <chapter num="04" heading="Hearing Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>These regulations apply to all formal hearings before the Board of Examiners of Professional Counselors.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the:</text> <paragraph num="(1)"> <text>Date, time, and place of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Issues or charges involved in the proceeding, provided, however, that if by reason of the nature of the proceeding, the issues cannot be stated in advance of the hearing, or if subsequent amendment of the issues is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Service upon a party shall be by delivery of the charging document and copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>Each party appearing at a formal hearing shall have the right to appear in proper person, or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Prehearing Procedures."> <paragraph num="A."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §A(1)(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board shall exclude from the hearing:</text> <paragraph num="(i)"> <text>The testimony of the expert; and</text> </paragraph> <paragraph num="(ii)"> <text>Any report of the expert.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The Board shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than as listed in §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(a)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Later than 15 days before the hearing if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prehearing Conferences. The Board may set prehearing conferences as it deems appropriate.</text> </paragraph> <paragraph num="C."> <text>Oaths and Subpoenas.</text> <paragraph num="(1)"> <text>The Board may administer oaths and compel the attendance of witnesses and the production of physical evidence before it from witnesses upon whom process is served anywhere within the State, as in civil cases in the circuit court of the county or of Baltimore City, by subpoena issued over the signature of the Chairman or Secretary and the seal of the Board.</text> </paragraph> <paragraph num="(2)"> <text>Upon a request by a party and statement under oath that the testimony or evidence is necessary to the party's defense, the Board shall issue a subpoena in the party's behalf.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Motions filed by a party shall be accompanied by a memorandum of points and authorities, and shall be filed with the Board at least 10 working days before the hearing, and a copy served on the opposing party. Any response shall be filed with the Board at least 5 working days before the hearing and a copy shall be served on the opposing party.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Board Majority. Each hearing shall be held before not less than a quorum of the Board unless the hearing authority is delegated pursuant to State Government Article, §10-207, Annotated Code of Maryland. A delegation of authority shall be subject to the provisions of State Government Article, §10-212. If hearing authority is not delegated, Board action shall be by a majority vote of those Board members then serving on the Board.</text> </paragraph> <paragraph num="B."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The Chairman, or in the Chairman's absence a member designated by the Chairman, shall be the presiding officer, or if in a delegated hearing, an administrative law judge under State Government Article, §§9-1601—9-1610, Annotated Code of Maryland, shall be the presiding officer.</text> </paragraph> <paragraph num="(2)"> <text>The presiding officer shall:</text> <paragraph num="(a)"> <text>Have complete charge of the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Permit the examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Admit evidence;</text> </paragraph> <paragraph num="(d)"> <text>Rule on the admissibility of evidence; and</text> </paragraph> <paragraph num="(e)"> <text>Adjourn or recess the hearing from time to time.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer may set reasonable time limits on arguments and presentation of evidence.</text> </paragraph> <paragraph num="(4)"> <text>The presiding officer shall be responsible for decorum in hearings and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The Board may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board.</text> </paragraph> <paragraph num="(2)"> <text>The member of the Office of the Attorney General presenting the case on behalf of the Board shall have all the following rights:</text> <paragraph num="(a)"> <text>The submission of evidence;</text> </paragraph> <paragraph num="(b)"> <text>Examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>Filing of objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Order of Procedure. The State shall present its case first. Then the respondent shall present his case. After this the State may present rebuttal.</text> </paragraph> <paragraph num="E."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Each party has the right to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine witnesses called by the Board or other party;</text> </paragraph> <paragraph num="(c)"> <text>Present summation and argument and file objections, exceptions, and motions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a party is represented by counsel, the submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel.</text> </paragraph> <paragraph num="(4)"> <text>Witnesses.</text> <paragraph num="(a)"> <text>The presiding officer, or any person designated by the presiding officer for the purpose, may examine any witness called to testify.</text> </paragraph> <paragraph num="(b)"> <text>The presiding officer may call as witness any person in attendance at the hearing.</text> </paragraph> <paragraph num="(c)"> <text>Any member of the Board may examine any witness called to testify.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If an accused or complainant fails to appear at a hearing after due notice, the Board or its designee may reschedule the hearing, or may proceed upon the available investigation, report, documents, witnesses, and records.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcript."> <paragraph num="A."> <text>The Board shall prepare an official record which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceedings, or part of them, shall be paid by the party requesting the transcript.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <paragraph num="A."> <text>Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law.</text> </paragraph> <paragraph num="B."> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or attorney of record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>A party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on the party of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it shall stay the enforcement of the order, or excuse the person affected for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeals."> <text>A person whose certificate has been revoked or suspended by the Board, or a person placed on probation or reprimand under the regulations in this chapter, may appeal the Board's decision as provided by the law.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Summary Suspension of a License or Certificate."> <paragraph num="A."> <text>Pursuant to State Government Article, §10- 226(c)(2), Annotated Code of Maryland, the Board may order the summary suspension of a license holder if the Board determines that there is substantial likelihood that a licensee or certificate holder poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of intent to summarily suspend a license or certificate; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license or certificate or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license or certificate shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact that the Board believes demonstrate a substantial likelihood that the licensee or certificate holder poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license or certificate not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license or certificate upon the respondent as described in §B(4)(b) of this regulation, the Board may nevertheless proceed to prosecute the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity to Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license or certificate, the respondent may request an opportunity to appear before the Board to show cause why the respondent’s license or certificate should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>Predeprivation Show Cause Hearing Before Board.</text> <paragraph num="(a)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not duly repetitious, if the presiding Board member believes that such documents or exhibits are necessary for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension Without Prior Notice or Hearing Opportunity.</text> <paragraph num="(1)"> <text>Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license or certificate without first issuing a notice of intent to summarily suspend a license or certificate or providing a respondent with an opportunity for a predeprivation hearing if the Board determines that:</text> <paragraph num="(a)"> <text>The public health, safety, and welfare require the immediate suspension of the license; and</text> </paragraph> <paragraph num="(b)"> <text>Prior notice and an opportunity to be heard are not feasible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Time — Service and Hearing.</text> <paragraph num="(a)"> <text>An order of summary suspension under section §D(1) of this regulation shall be served upon the respondent within 48 hours after its execution.</text> </paragraph> <paragraph num="(b)"> <text>The respondent may request a show cause hearing before the Board within 30 days after the effective date of the summary suspension. The request shall be made within 10 days of the date of the notice of sumary suspension.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall:</text> <paragraph num="(a)"> <text>Be conducted before the Board as provided in §D(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license or certificate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent’s license or certificate.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license or certificate before summarily suspending a license or certificate, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including an order providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind its order of summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including an order providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10–611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Postdeprivation Opportunity for Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license or certificate under §C or D of this regulation, the respondent may request an evidentiary hearing before the Board, or if the Board delegates the matter to the Office of Administrative hearings, before an administrative law judge.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after the respondent’s request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge shall issue a recommended decision to the Board with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a), (b), or (c) of this regulation, pursuant to the Board’s delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge’s determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exemptions to the recommended decision, as provided in State Government Article, §10–216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a post-deprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10–611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-205, 17-509, and 17-511; State Government Article, §§10-205, 10-206, 10-216, and 10-226(c)(2); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 2, 1990 (17:6 Md. R. 742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 20, 2000 (27:5 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective September 14, 2015 (42:18 Md. R. 1175)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all professional counselors and therapists who wish to renew or reinstate their licensure or certification in the State.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited institution of higher education” means a college or university accredited by a national or regional accrediting body recognized by the Council on Post-Secondary Accreditation.</text> </paragraph> <paragraph num="(2)"> <text>“Activity” means any program, publication, course, institute, seminar, lecture, conference, workshop, symposium, or professional meeting that meets the criteria and objectives of continuing education.</text> </paragraph> <paragraph num="(3)"> <text>“Approved program” means an activity that has been reviewed and approved by the Board for Category A credit.</text> </paragraph> <paragraph num="(4)"> <text>“Authorized sponsor” means an organization or individual reviewed and authorized by the Board, or automatically eligible, to present Category A programs.</text> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Board of Examiners of Professional Counselors and Therapists.</text> </paragraph> <paragraph num="(6)"> <text>“Committee” means the Advisory Committee for Continuing Education, appointed by the Board, consisting of at least one member of the Board.</text> </paragraph> <paragraph num="(7)"> <text>“Continuing education” means additional professional activities beyond that required for certification or licensure.</text> </paragraph> <paragraph num="(8)"> <text>“Continuing education unit (CEU)” means 60 minutes of activity that is approved by the Board to fulfill the continuing education requirements.</text> </paragraph> <paragraph num="(9)"> <text>“Course” means a series of meetings with defined content and systematic presentation with an instructor, as an expert, who imparts information to the participants.</text> </paragraph> <paragraph num="(10)"> <text>“Home study” means independent study that:</text> <paragraph num="(a)"> <text>Is not evaluated by a formal process documenting a minimum mastery of materials; and</text> </paragraph> <paragraph num="(b)"> <text>Does not issue a verification of program completion.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Renewal date” means the date upon which a certificate or license expires, as specified in the notice sent to the certified or licensed professional counselor by the Board in accordance with Health Occupations Article, §§17-309(b) and 17-3A-08(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Renewal period” means the 2-year period immediately before the renewal date.</text> </paragraph> <paragraph num="(13)"> <text>“Seminar” means a meeting or meetings of highly experienced participants or experts with an expert leader who conducts a discussion on a specific topic.</text> </paragraph> <paragraph num="(14)"> <text>“Symposium” means a presentation or presentations by two or more speakers with different views on a specific topic and with a discussant who summarizes the issues.</text> </paragraph> <paragraph num="(15)"> <text>“Workshop” means a meeting or meetings of general sessions and face-to-face groups with a leader, an expert in the defined content area, who imparts information to participants who have ample opportunity to interact.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements."> <paragraph num="A."> <text>CEU Requirements. The certificate or license holder shall complete a minimum of 40 CEUs in each renewal period, as follows:</text> <paragraph num="(1)"> <text>At least 30 CEUs shall be in Category A activities and not more than 10 CEUs may be in Category B activities; or</text> </paragraph> <paragraph num="(2)"> <text>All 40 CEUs may be in Category A activities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CEUs that are in excess of requirements may not be carried over to the next renewal period.</text> </paragraph> <paragraph num="C."> <text>A certificate or license holder who has a renewal period of less than 2 years shall complete a minimum of 20 Category A CEUs for that renewal period.</text> </paragraph> <paragraph num="D."> <text>Proof of Completion.</text> <paragraph num="(1)"> <text>A license or certificate holder shall attest to completion of required CEUs at the time of renewal or reinstatement, on a form supplied by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The license or certificate holder shall obtain the requisite documentation of CEU attendance and retain this documentation for the succeeding 4 years for possible inspection by the Board.</text> </paragraph> <paragraph num="(3)"> <text>Required Documentation of Category A and Category B Activities.</text> <paragraph num="(a)"> <text>The required documentation of Category A activities as defined in Regulations .04 and .05 of this chapter include:</text> <paragraph num="(i)"> <text>Certificates of participation;</text> </paragraph> <paragraph num="(ii)"> <text>Transcripts;</text> </paragraph> <paragraph num="(iii)"> <text>Reprints of publications;</text> </paragraph> <paragraph num="(iv)"> <text>Proof of presentations; or</text> </paragraph> <paragraph num="(v)"> <text>Any other information necessary to verify compliance with the requirements of Regulations .04 and .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The required documentation of Category B activities as defined in Regulations .04 and .06 of this chapter, include:</text> <paragraph num="(i)"> <text>Dates;</text> </paragraph> <paragraph num="(ii)"> <text>Names of presenters;</text> </paragraph> <paragraph num="(iii)"> <text>Outlines of presentations;</text> </paragraph> <paragraph num="(iv)"> <text>Topics of meetings; or</text> </paragraph> <paragraph num="(v)"> <text>Any other information necessary to verify compliance with the requirements of Regulations .04 and .06 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The license or certificate holder shall demonstrate that the CEU activity fell within the renewal period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Continuing Education Qualifications."> <paragraph num="A."> <text>To qualify for approval by the Board, continuing education activities shall employ didactic and experiential methods to meet one of the following objectives:</text> <paragraph num="(1)"> <text>Maintain professional competency;</text> </paragraph> <paragraph num="(2)"> <text>Increase professional skills and knowledge;</text> </paragraph> <paragraph num="(3)"> <text>Prepare for new roles or responsibilities in the practice of counseling or therapy; or</text> </paragraph> <paragraph num="(4)"> <text>Expand the science of counseling and therapy theory, method, or practice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following activities are specifically excluded from continuing education credit and do not meet any required objective:</text> <paragraph num="(1)"> <text>Business meetings, professional committee meetings, and meetings concerned with the management of a professional practice;</text> </paragraph> <paragraph num="(2)"> <text>Presentations and publications intended for a lay audience; and</text> </paragraph> <paragraph num="(3)"> <text>Home study.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Categories of Continuing Education — Category A."> <paragraph num="A."> <text>The Board may approve the following activities for CEUs in Category A:</text> <paragraph num="(1)"> <text>Attending formally organized Category A programs as follows:</text> <paragraph num="(a)"> <text>The programs shall meet the following criteria:</text> <paragraph num="(i)"> <text>The program is offered by a sponsor approved by the Board to present Category A programs,</text> </paragraph> <paragraph num="(ii)"> <text>The program is intended for a professional mental health audience,</text> </paragraph> <paragraph num="(iii)"> <text>The program has a stated purpose and defined content area,</text> </paragraph> <paragraph num="(iv)"> <text>Presenters are professionals qualified in the defined content area,</text> </paragraph> <paragraph num="(v)"> <text>The program's time period is clearly stated,</text> </paragraph> <paragraph num="(vi)"> <text>Registration and attendance is recorded by the program's sponsor,</text> </paragraph> <paragraph num="(vii)"> <text>Documentation of completion is provided, and</text> </paragraph> <paragraph num="(viii)"> <text>Participants are required to complete an evaluation of the program; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The program may be formally organized and classified as a course, workshop, seminar, or symposium;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Developing and presenting a Category A program which is credited as follows:</text> <paragraph num="(a)"> <text>Up to 3 hours of CEU credit may be claimed by the presenter for each hour of presentation of the program with a maximum of 20 CEUs;</text> </paragraph> <paragraph num="(b)"> <text>Up to 3 hours of CEU credit may be claimed for each hour of presentation, at a professional or scientific organization, of a professional or scientific paper prepared by the licensee or certificate holder, with a maximum of 6 CEUs per paper; and</text> </paragraph> <paragraph num="(c)"> <text>Each program may be credited only once in each renewal period; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Authoring, editing, or reviewing a juried publication with CEUs earned only in the year of publication, and only to the following extent:</text> <paragraph num="(a)"> <text>Author of a book—maximum of 40 CEUs;</text> </paragraph> <paragraph num="(b)"> <text>Author of a book chapter or journal article—maximum of 15 CEUs;</text> </paragraph> <paragraph num="(c)"> <text>Editor of a book—maximum of 30 CEUs;</text> </paragraph> <paragraph num="(d)"> <text>Editor of a scientific or professional journal recognized by the Board—maximum of 30 CEUs for each year of service; or</text> </paragraph> <paragraph num="(e)"> <text>Reviewer of a professional book, scientific journal, or professional journal recognized by the Board—maximum of 10 CEUs for each year of service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When a certificate holder or licensee, after meeting the education requirements for certification or licensure at the degree level at which the licensee or certificate holder became certified or licensed, completes for credit semester hours of qualifying graduate-level or undergraduate-level course work at an accredited institution of higher education, each semester hour is considered the equivalent of 15 hours of CEUs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Categories of Continuing Education — Category B."> <paragraph num="A."> <text>The Board may approve the following activities for CEUs in Category B:</text> <paragraph num="(1)"> <text>Attendance at or presentation of informal courses, in-house colloquia, invited speaker sessions, in-house seminars, and case conferences which are specifically designed for training, teaching, or both;</text> </paragraph> <paragraph num="(2)"> <text>Attendance at or presentation of informal non-publicized programs offered at professional or scientific meetings of local, state, regional, national, and international professional or scientific organizations; or</text> </paragraph> <paragraph num="(3)"> <text>Individualized learning, such as receiving formal professional supervision (except administrative supervision), participation in peer case conference or peer supervision groups, and participation in distance learning programs with evidence of appropriateness, minimum mastery of materials, and completion.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Programs that do not meet the criteria for Category A may be eligible for Category B if the programs meet the objectives of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Authorization of Sponsored Continuing Education Programs."> <paragraph num="A."> <text>Authorizing Sponsored Programs.</text> <paragraph num="(1)"> <text>The Board shall establish a committee to advise the Board on continuing education.</text> </paragraph> <paragraph num="(2)"> <text>The committee shall evaluate and the Board may authorize applicants to sponsor Category A programs.</text> </paragraph> <paragraph num="(3)"> <text>The committee may recommend Board approval of programs by authorized sponsors for Category A according to the objectives stated in Regulations .04A and .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Criteria for Program Eligibility.</text> <paragraph num="(1)"> <text>The Board shall evaluate each continuing education program submitted on the basis of the following criteria:</text> <paragraph num="(a)"> <text>Relevance of the subject matter to increase or support the development of skill and competence in counseling or therapy;</text> </paragraph> <paragraph num="(b)"> <text>Objectives of specific information or skill to be learned;</text> </paragraph> <paragraph num="(c)"> <text>Program content, educational methods, materials, and facilities used, including the frequency and duration of sessions and the adequacy to implement objectives; and</text> </paragraph> <paragraph num="(d)"> <text>Sponsorship and leadership of programs, including:</text> <paragraph num="(i)"> <text>The qualifications of the sponsoring individual or organization,</text> </paragraph> <paragraph num="(ii)"> <text>Program leaders if different from sponsors, and</text> </paragraph> <paragraph num="(iii)"> <text>The contact person if different from those in §B(1)(d)(i) or (ii) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program sponsored by the American Counseling Association, the National Board for Certified Counselors, the American Association for Marriage and Family Therapy, the National Association of Alcohol and Drug Abuse Counselors, the International Certification and Reciprocity Consortium/Alcohol and Other Drug Abuse, Inc., any other national or international organization, or their regional or state affiliates is automatically approved by the Board for Category A, unless otherwise excluded.</text> </paragraph> <paragraph num="(3)"> <text>A program sponsored by an accredited institution of higher education and state departments of health is automatically approved by the Board for Category A, unless otherwise excluded.</text> </paragraph> <paragraph num="(4)"> <text>The following may be authorized to sponsor Category A programs upon application and approval by the Board:</text> <paragraph num="(a)"> <text>National, state, or local professional, scientific, or mental health organizations;</text> </paragraph> <paragraph num="(b)"> <text>Those individuals certified or licensed by the Board; and</text> </paragraph> <paragraph num="(c)"> <text>Other agencies, institutions, or organizations providing continuing education programs in the interest of carrying out the intent of Health Occupations Article, §§17-309 and 17-3A-08, Annotated Code of Maryland, and Regulations .04 and .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Procedures for Pre-approval.</text> <paragraph num="(1)"> <text>An application, on a form provided by the Board, shall be made and fee submitted to the Board for authorization of programs of sponsoring agencies meeting the requirements of these regulations.</text> </paragraph> <paragraph num="(2)"> <text>The application shall be submitted to the committee at least 10 weeks before the scheduling of each continuing education program.</text> </paragraph> <paragraph num="(3)"> <text>Authorized sponsors shall state in the continuing education program description the following:</text> <paragraph num="(a)"> <text>“A certificate for (number of hours) CEUs of Category A will be awarded upon completion of this (type of program)”;</text> </paragraph> <paragraph num="(b)"> <text>“(Name of organization) has been approved by the Maryland State Board of Examiners as an authorized sponsor who may provide Category A CEUs for certified or licensed professional counselors, marriage and family therapists, and alcohol and drug counselors”; and</text> </paragraph> <paragraph num="(c)"> <text>“(Name of organization) maintains responsibility for the program”.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Authorized sponsors shall maintain documentation of registration and attendance records, stated purpose, content and presentation, time and length of the activity, and participant evaluations for a 4-year period following the program that may be audited by the Board.</text> </paragraph> <paragraph num="(5)"> <text>Approved sponsors' programs shall be approved for a 2-year period except as otherwise provided in §D of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>Certificate holders and licensees may request, upon payment of a fee, that the Board review programs that do not have pre-approval for awarding CEU units.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Withdrawal of Approval. Authorization may be withdrawn when, in the judgment of the Board, the intent of Health Occupations Article, §§17-309 and 17-3A-08, Annotated Code of Maryland, and Regulations .04, .05, and .06 of this chapter are no longer served.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Failure to Meet Continuing Education Requirements."> <paragraph num="A."> <text>Reporting Requirements.</text> <paragraph num="(1)"> <text>The certificate holder or licensee shall complete and submit a form attesting to satisfactory completion of the continuing education requirements for each renewal.</text> </paragraph> <paragraph num="(2)"> <text>The certificate holder or licensee who is audited shall provide full documentation of CEUs as set forth in Regulation .03D of this chapter on a completed form provided by the Board.</text> </paragraph> <paragraph num="(3)"> <text>The Board shall audit a percentage of certificate holders and licensees to be determined by the Board each renewal period.</text> </paragraph> <paragraph num="(4)"> <text>A certificate holder or licensee who fails to renew by the renewal date shall provide full documentation as set forth in Regulation .03D of this chapter on a completed form provided by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Extension of Time to Meet CEU Requirements.</text> <paragraph num="(1)"> <text>A written request for an extension of time in which to complete CEU requirements shall be submitted by the certificate holder's or licensee's renewal date.</text> </paragraph> <paragraph num="(2)"> <text>The Board may grant an extension and renew a certificate or license if the Board determines that:</text> <paragraph num="(a)"> <text>Failure to fulfill the requirements is clearly a result of a significant illness, a procedural or technical difficulty, or other circumstances beyond the control of the certificate holder or licensee; and</text> </paragraph> <paragraph num="(b)"> <text>The certificate holder or licensee readily and appropriately attempted to fulfill the CEU requirements.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may deny the request for an extension, deny renewal of the certificate or license, or issue any other order the Board finds appropriate.</text> </paragraph> <paragraph num="(4)"> <text>CEUs which are acquired in order to fulfill the conditions of an extension may be credited only for the previous renewal period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reinstatement."> <paragraph num="A."> <text>Within 1 calendar year after the certificate or license renewal date, the Board may reinstate the certificate or license of a certificate holder or licensee otherwise entitled to reinstatement under Health Occupations Article, §§17-310(b) and 17-3A-09(b), Annotated Code of Maryland, whose certificate or license was not renewed due to failure to complete continuing education requirements for renewal if the certificate holder or licensee:</text> <paragraph num="(1)"> <text>Completed within that year the minimum of 40 CEUs required during the prior renewal period as set forth in Regulation .03A of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a reinstatement fee set by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CEUs which are acquired in order to reinstate under §A(1) of this regulation may be credited only once and may not be credited for any future renewals.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Inactive Status."> <paragraph num="A."> <text>In accordance with Health Occupations Article, §§17-310 and 17-3A-09, Annotated Code of Maryland, a request to transfer a certificate or license to inactive status shall be granted on written request and payment of the fee set forth in COMAR 10.58.02.</text> </paragraph> <paragraph num="B."> <text>The procedure as shown in §A of this regulation may occur only if the certificate or license is still active at the time application for inactive status is made.</text> </paragraph> <paragraph num="C."> <text>A certificate holder or licensee on inactive status seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed:</text> <paragraph num="(1)"> <text>40 Category A CEUs for 2 or less years of inactive status; or</text> </paragraph> <paragraph num="(2)"> <text>80 Category A CEUs for 3 or more years of inactive status, at least 40 of which shall have been obtained within the 2-year period immediately preceding the application for reinstatement.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §17-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 13, 1991 (18:9 Md. R. 1009)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective August 3, 1992 (19:15 Md. R. 1391)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 repealed and new Regulations .01—.10 adopted effective September 4, 2000 (27:17 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07B amended effective July 8, 2002 (29:13 Md. R. 992)</annotation> </annotations> </chapter> <chapter num="06" heading="Teletherapy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of counseling and therapy services in Maryland pursuant to Health Occupations Article, Title 17, Annotated Code of Maryland, using teletherapy as an adjunct to, or replacement for, in-person client visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter changes, restricts, or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Professional Counselors and Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“Client” means the individual, couple, family, group, business, agency, school, organization, or association that the counselor or therapist provides, or has provided, with professional services.</text> </paragraph> <paragraph num="(4)"> <text>“Counselor or therapist” means an individual who is licensed or certified by the Board to practice:</text> <paragraph num="(a)"> <text>Certified associate alcohol and drug counseling;</text> </paragraph> <paragraph num="(b)"> <text>Certified professional counseling;</text> </paragraph> <paragraph num="(c)"> <text>Certified professional alcohol and drug counseling;</text> </paragraph> <paragraph num="(d)"> <text>Certified professional marriage and family therapy;</text> </paragraph> <paragraph num="(e)"> <text>Certified supervised alcohol and drug counseling;</text> </paragraph> <paragraph num="(f)"> <text>Clinical marriage and family therapy;</text> </paragraph> <paragraph num="(g)"> <text>Clinical professional alcohol and drug counseling;</text> </paragraph> <paragraph num="(h)"> <text>Clinical professional art therapy;</text> </paragraph> <paragraph num="(i)"> <text>Clinical professional counseling;</text> </paragraph> <paragraph num="(j)"> <text>Graduate alcohol and drug counseling;</text> </paragraph> <paragraph num="(k)"> <text>Graduate marriage and family therapy;</text> </paragraph> <paragraph num="(l)"> <text>Graduate professional art therapy; or</text> </paragraph> <paragraph num="(m)"> <text>Graduate professional counseling.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“In-person” means within the physical presence of the client.</text> </paragraph> <paragraph num="(6)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(7)"> <text>“Teletherapy” means telehealth as defined in Health Occupations Article, §1-901, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Teletherapy practitioner” means:</text> <paragraph num="(a)"> <text>A Maryland licensed individual authorized to provide counseling and therapy services pursuant to Health Occupations Article, Title 17, Annotated Code of Maryland, who performs teletherapy services within their respective scope of practice; or</text> </paragraph> <paragraph num="(b)"> <text>A professional counselor with a compact privilege in Maryland who performs telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure and Certification."> <text>Subject to the provisions of Health Occupations Article, Title 17, Subtitles 3 and 4, Annotated Code of Maryland, in order to practice teletherapy a teletherapy practitioner shall be licensed in Maryland or hold a compact privilege in Maryland when providing teletherapy services to a client located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Teletherapy."> <paragraph num="A."> <text>Before providing teletherapy services, a teletherapy practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the client receiving teletherapy services through the use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(c)"> <text>Documentation of the client’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial client-teletherapy practitioner encounter, disclose the teletherapy practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license or certificate number and type or compact privilege number, if applicable; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written informed consent from a client or a client’s parent or guardian if State law requires the consent of a parent or guardian, including informing clients of potential risks and benefits of services to be performed;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a client’s clinical data and self-reported medical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify clients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the teletherapy practitioner provides a secure and private communication modality and complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous teletherapy services, a teletherapy practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the client is in Maryland and identify the client’s specific location; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are permitted to hear the client’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A teletherapy practitioner shall be held to the same standards of practice and documentation as those applicable for in-person counseling and therapy sessions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Client Evaluation."> <paragraph num="A."> <text>A teletherapy practitioner shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical client evaluation that is appropriate for the client and the condition with which the client presents before providing treatment or services through teletherapy; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the client, provide or refer a client to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of teletherapy service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A teletherapy practitioner may not treat a client based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Teletherapy Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards in evaluating and investigating a complaint and disciplining an individual authorized to practice pursuant to Health Occupations Article, Title 17, Annotated Code of Maryland, who practices teletherapy as it would use for an individual authorized to practice pursuant to Health Occupations Article, Title 17, Annotated Code of Maryland, who does not use teletherapy technology in their counseling or therapy practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a teletherapy practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-141.2; Health Occupations Article, §§1-901—1-903 and 1-1001—1-1006; and Insurance Article; §15-139, Annotated Code of Maryland; Ch. 505, Acts of 2008</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted as an emergency provision effective December 14, 1998 (26:1 Md. R. 18); adopted permanently effective May 31, 1999 (26:11 Md. R. 855)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 18, 1999 (26:21 Md. R. 1630)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03, Licensure by Waiver, repealed and new Regulations .01—.06, Teletherapy, adopted effective June 17, 2019 (46:12 Md. R. 546)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective September 18, 2023 (50:18 Md. R. 798)</annotation> </annotations> </chapter> <chapter num="07" heading="Alcohol and Drug Counselors — Requirements for Certification and Licensure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to alcohol and drug counselors and alcohol and drug trainees in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means a Board-approved college or university that is accredited by a national or regional accrediting body recognized by the Council on Post-Secondary Accreditation or through one of the following bodies recognized by the U.S. Department of Education:</text> <paragraph num="(a)"> <text>The Middle States Association of Colleges and Schools — the Commission on Higher Education;</text> </paragraph> <paragraph num="(b)"> <text>The New England Association of Schools and Colleges;</text> </paragraph> <paragraph num="(c)"> <text>The North Central Association of Schools and Colleges;</text> </paragraph> <paragraph num="(d)"> <text>The Northwest Association of Schools and of Colleges and Universities;</text> </paragraph> <paragraph num="(e)"> <text>The Southern Association of Colleges and Schools; or</text> </paragraph> <paragraph num="(f)"> <text>The Western Association of Colleges and Schools.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Appraisal” means:</text> <paragraph num="(a)"> <text>Selecting, administering, scoring, and interpreting instruments designed to assess an individual’s aptitudes, attitudes, abilities, achievements, interests, and personal characteristics; and</text> </paragraph> <paragraph num="(b)"> <text>Using nonstandardized methods and techniques for understanding human behavior in relation to coping with, adapting to, or changing life situations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Approved alcohol and drug counselor supervisor” means a Board-approved:</text> <paragraph num="(a)"> <text>Licensed clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(b)"> <text>Health-care provider:</text> <paragraph num="(i)"> <text>Licensed under the Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>With 3 years of documented experience in alcohol and drug counseling;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Certified professional counselor-alcohol and drug;</text> </paragraph> <paragraph num="(d)"> <text>Certified associate counselor-alcohol and drug with 3 years of documented experience in alcohol and drug counseling;</text> </paragraph> <paragraph num="(e)"> <text>Licensed clinical professional counselor;</text> </paragraph> <paragraph num="(f)"> <text>Licensed clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(g)"> <text>Licensed clinical professional art therapist.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Biopsychosocial evaluation” means a comprehensive assessment of the patient addressing the following areas:</text> <paragraph num="(a)"> <text>Physical health;</text> </paragraph> <paragraph num="(b)"> <text>Employment or financial support;</text> </paragraph> <paragraph num="(c)"> <text>Drug and alcohol use;</text> </paragraph> <paragraph num="(d)"> <text>Treatment history;</text> </paragraph> <paragraph num="(e)"> <text>Legal history;</text> </paragraph> <paragraph num="(f)"> <text>Familial and social relationships;</text> </paragraph> <paragraph num="(g)"> <text>Educational background; and</text> </paragraph> <paragraph num="(h)"> <text>Mental health.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Case management” means the provision of services which assist participants in gaining access to:</text> <paragraph num="(a)"> <text>The full range of substance abuse services; or</text> </paragraph> <paragraph num="(b)"> <text>Any additional needed medical, social, financial assistance, counseling, educational, housing services.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Clinical supervision” means that the supervisor:</text> <paragraph num="(a)"> <text>Controls the supervisees’ work, and provides face-to-face or immediately available supervision;</text> </paragraph> <paragraph num="(b)"> <text>Evaluates completed work for technical soundness, appropriateness, and conformity to policy and requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Confirms that all diagnoses are clinically supported by appropriate criteria, as:</text> <paragraph num="(i)"> <text>Defined in the current editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the International Classification of Diseases and Related Health Problems (ICD); and</text> </paragraph> <paragraph num="(ii)"> <text>Documented by signature and credentials.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Close supervision” means that the supervisor:</text> <paragraph num="(a)"> <text>Closely controls the supervisees’ work, and provides direct, face-to-face, or on-site supervision;</text> </paragraph> <paragraph num="(b)"> <text>Maintains control through review of case management and progress notes, treatment plan reviews, and other documentation as appropriate;</text> </paragraph> <paragraph num="(c)"> <text>Evaluates completed work for accuracy, detail, and adherence to instructions and established procedures; and</text> </paragraph> <paragraph num="(d)"> <text>Reviews and approves content for all diagnostic impressions and new treatment plans, as documented by signature and credentials.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Co-occurring disorders (CODs)” means the occurrence in any individual, simultaneously or sequentially, of two or more somatic or behavioral health disorders which may imply an interaction between the disorders that affect the course and prognosis of each diagnosis.</text> </paragraph> <paragraph num="(9)"> <text>“Diagnosis” means the identification of psychological problems, emotional, or mental disorders by a licensed clinician, using specified terms and criteria identified in the current editions of the:</text> <paragraph num="(a)"> <text>Diagnostic and Statistical Manual of Mental Disorders (DSM); or</text> </paragraph> <paragraph num="(b)"> <text>International Classification of Diseases and Related Health Problems (ICD).</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Direct clinical counseling services” means the provision of face-to-face clinical professional counseling services to clients and their significant others that include, but are not limited to the following:</text> <paragraph num="(a)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Family counseling;</text> </paragraph> <paragraph num="(d)"> <text>Couples counseling;</text> </paragraph> <paragraph num="(e)"> <text>Evaluation;</text> </paragraph> <paragraph num="(f)"> <text>Intake or Assessment;</text> </paragraph> <paragraph num="(g)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(h)"> <text>Treatment planning with a client; and</text> </paragraph> <paragraph num="(i)"> <text>Crisis management or intervention.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Direct supervision” means supervision provided by a supervisor who is present on the premises where services are provided, and is available for consultation within the treatment area.</text> </paragraph> <paragraph num="(12)"> <text>Face-to-Face.</text> <paragraph num="(a)"> <text>“Face-to-face” means in the physical presence of an individual or using video conferencing which allows individuals to hear and see each other in synchronous points of time.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face” does not include:</text> <paragraph num="(i)"> <text>Telephone supervision; or</text> </paragraph> <paragraph num="(ii)"> <text>Internet communication that does not involve synchronous video conferencing, such as instant messaging services and social networking sites.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Health and human services counseling field” means a specific degree program with a counseling emphasis, including but not limited to the following areas:</text> <paragraph num="(a)"> <text>Addictions counseling, including:</text> <paragraph num="(i)"> <text>Alcohol and drug counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Substance abuse counseling; or</text> </paragraph> <paragraph num="(iii)"> <text>Chemical dependence counseling;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Counseling practiced under Health Occupations Article, Title 17, Annotated Code of Maryland, including:</text> <paragraph num="(i)"> <text>Professional counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Marriage and family therapy; or</text> </paragraph> <paragraph num="(iii)"> <text>Art therapy;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Practice areas of other mental health care providers, including, but not limited to:</text> <paragraph num="(i)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(ii)"> <text>Psychology;</text> </paragraph> <paragraph num="(iii)"> <text>Social work; or</text> </paragraph> <paragraph num="(iv)"> <text>Psychiatric nursing;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Other academic concentrations in the health and human services field, including, but not limited to:</text> <paragraph num="(i)"> <text>Human services;</text> </paragraph> <paragraph num="(ii)"> <text>Behavioral health or behavioral sciences;</text> </paragraph> <paragraph num="(iii)"> <text>Rehabilitation counseling;</text> </paragraph> <paragraph num="(iv)"> <text>Counselor education;</text> </paragraph> <paragraph num="(v)"> <text>Counseling psychology; or</text> </paragraph> <paragraph num="(vi)"> <text>Human development.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Immediately available supervision” means supervision provided by a supervisor who is instantly available:</text> <paragraph num="(a)"> <text>In person;</text> </paragraph> <paragraph num="(b)"> <text>By telephone or other electronic means; or</text> </paragraph> <paragraph num="(c)"> <text>By designation of one or more supervisors in the absence of the supervisor of record.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Indirect clinical counseling services” means all case management and professional development activities related to the provision of clinical professional counseling services to a client that include but are not limited to the following:</text> <paragraph num="(a)"> <text>Referral;</text> </paragraph> <paragraph num="(b)"> <text>Intake or assessment by telephone or other means when client is not face-to-face;</text> </paragraph> <paragraph num="(c)"> <text>Receiving individual and group supervision on-site or at a university;</text> </paragraph> <paragraph num="(d)"> <text>Consultation with other professionals;</text> </paragraph> <paragraph num="(e)"> <text>Treatment planning with other professionals;</text> </paragraph> <paragraph num="(f)"> <text>Case staffing;</text> </paragraph> <paragraph num="(g)"> <text>Staff meetings;</text> </paragraph> <paragraph num="(h)"> <text>Related trainings and seminars;</text> </paragraph> <paragraph num="(i)"> <text>Record keeping;</text> </paragraph> <paragraph num="(j)"> <text>Report writing;</text> </paragraph> <paragraph num="(k)"> <text>Case note taking;</text> </paragraph> <paragraph num="(l)"> <text>Providing clinical training;</text> </paragraph> <paragraph num="(m)"> <text>Telephone triage;</text> </paragraph> <paragraph num="(n)"> <text>Case management;</text> </paragraph> <paragraph num="(o)"> <text>Program development; and</text> </paragraph> <paragraph num="(p)"> <text>Other clinical professional counselor administrative duties as required by the setting in which the clinical hours are accrued.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Licensed graduate alcohol and drug counselor” means an individual approved by the Board to practice graduate alcohol and drug counseling under the supervision of an approved alcohol and drug counselor supervisor while fulfilling the supervised clinical experience for licensure under:</text> <paragraph num="(a)"> <text>Health Occupations Article, §17-302(e), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Moderate supervision” means that the supervisor:</text> <paragraph num="(a)"> <text>Controls the supervisee’s work and provides face-to-face or immediately available supervision;</text> </paragraph> <paragraph num="(b)"> <text>Ensures that completed work and methods used are technically accurate and in compliance with instructions or established procedures;</text> </paragraph> <paragraph num="(c)"> <text>Provides more intense review for difficult assignments, if the supervisee has not previously performed similar assignments; and</text> </paragraph> <paragraph num="(d)"> <text>Reviews and approves content for all diagnostic impressions and new treatment plans, as documented by signature and credentials.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>Ongoing Process of Supervision.</text> <paragraph num="(a)"> <text>“Ongoing process of supervision” means that the supervisor is available to provide support for the supervisee’s day-to-day practice of alcohol and drug counseling, throughout the course of the supervisee’s scheduled work hours;</text> </paragraph> <paragraph num="(b)"> <text>“Ongoing process of supervision” includes close, moderate, or clinical supervision of an individual or a group.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“On-site supervision” means supervision provided by a supervisor who is:</text> <paragraph num="(a)"> <text>Physically present in the facility where patient or client services are rendered; and</text> </paragraph> <paragraph num="(b)"> <text>Able to respond in person without delay.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Participating in the development of diagnostic impressions.</text> <paragraph num="(a)"> <text>“Participating in the development of diagnostic impressions” means gathering information to support a diagnosis through:</text> <paragraph num="(i)"> <text>Screening and assessment activities;</text> </paragraph> <paragraph num="(ii)"> <text>Observations of signs and symptoms;</text> </paragraph> <paragraph num="(iii)"> <text>Reports of behaviors;</text> </paragraph> <paragraph num="(iv)"> <text>Collateral information acquired with the appropriate release; and</text> </paragraph> <paragraph num="(v)"> <text>The identification of specific disorders to be ruled out by the diagnosing clinician.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Participating in the development of diagnostic impressions” does not include diagnosis.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Practice clinical alcohol and drug counseling” means to engage professionally and for compensation in alcohol and drug counseling and appraisal activities by providing services for individuals, couples, families and groups involving:</text> <paragraph num="(a)"> <text>The application of counseling principles; and</text> </paragraph> <paragraph num="(b)"> <text>Methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Psychotherapy” means providing clinical services which involve:</text> <paragraph num="(a)"> <text>The professional application of psychotherapy and counseling theories and methods, including but not limited to psychodynamic, cognitive, behavioral, humanistic, systems theories, or trauma informed care to assist the client in:</text> <paragraph num="(i)"> <text>Improving functioning;</text> </paragraph> <paragraph num="(ii)"> <text>Obtaining symptom relief;</text> </paragraph> <paragraph num="(iii)"> <text>Preventing psychosocial dysfunction;</text> </paragraph> <paragraph num="(iv)"> <text>Changing personality; or</text> </paragraph> <paragraph num="(v)"> <text>Maintaining improved functioning; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Situations in which the principal discourse involves, but is not limited to:</text> <paragraph num="(i)"> <text>Diagnosis of psychopathology based on standard diagnostic criteria;</text> </paragraph> <paragraph num="(ii)"> <text>Psychotherapeutic treatment of mental disorders, emotional disorders, and adjustment reactions utilizing clinically appropriate treatment modalities;</text> </paragraph> <paragraph num="(iii)"> <text>Childhood trauma and abuse;</text> </paragraph> <paragraph num="(iv)"> <text>Identifying and changing self-defeating patterns of behaving, thinking, feeling, believing, or interacting with others in systems;</text> </paragraph> <paragraph num="(v)"> <text>Developmental issues;</text> </paragraph> <paragraph num="(vi)"> <text>Personality development; or</text> </paragraph> <paragraph num="(vii)"> <text>Problems related to disorders of thinking, emotional suffering, addictions, behavior, or interpersonal dysfunctions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Relative” means an individual connected to another by:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Marriage;</text> </paragraph> <paragraph num="(c)"> <text>Guardianship; or</text> </paragraph> <paragraph num="(d)"> <text>Domestic partnership.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“SBIRT” means Screening, Brief Intervention, and Referral to Treatment, including the following practices:</text> <paragraph num="(a)"> <text>Screening which quickly assesses the severity of substance use and identifies the appropriate level of treatment;</text> </paragraph> <paragraph num="(b)"> <text>Brief intervention which focuses on increasing insight and awareness regarding substance use and motivation toward behavioral change; and</text> </paragraph> <paragraph num="(c)"> <text>Referral to treatment which provides individuals identified as needing more extensive treatment with access to specialty care.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Scope of competence” means that area within which the individual is proficient to practice based on:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training;</text> </paragraph> <paragraph num="(c)"> <text>Supervised clinical experience; and</text> </paragraph> <paragraph num="(d)"> <text>Professional credentials.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Substance use disorders (SUDs)” means any problematic pattern of substance use leading to clinically significant impairment or distress, which is diagnosed using specified terms and criteria identified in the current editions of the:</text> <paragraph num="(a)"> <text>Diagnostic and Statistical Manual of Mental Disorders (DSM); or</text> </paragraph> <paragraph num="(b)"> <text>International Classification of Diseases and Related Health Problems (ICD).</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Supervised clinical experience in alcohol and drug counseling” means alcohol and drug counseling services provided under the close or moderate supervision of an approved licensed or certified alcohol and drug counselor supervisor.</text> </paragraph> <paragraph num="(28)"> <text>“Supervisee” means any of the following who obtains the supervised clinical experience required by Health Occupations Article, §17-302, Annotated Code of Maryland:</text> <paragraph num="(a)"> <text>A licensed graduate alcohol and drug counselor;</text> </paragraph> <paragraph num="(b)"> <text>A certified associate counselor-alcohol and drug;</text> </paragraph> <paragraph num="(c)"> <text>A certified supervised counselor-alcohol and drug; or</text> </paragraph> <paragraph num="(d)"> <text>An alcohol and drug trainee.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>Supervision.</text> <paragraph num="(a)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee that involves:</text> <paragraph num="(i)"> <text>Directing, guiding, monitoring, instructing, and evaluating the supervisee’s alcohol and drug counseling practice throughout an ongoing process of supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>Utilizes close, moderate, or clinical levels of supervision.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Supervision” includes an acceptance of direct responsibility for the patient services rendered by the supervisee, including continuous availability to the supervisee:</text> <paragraph num="(i)"> <text>In person;</text> </paragraph> <paragraph num="(ii)"> <text>Through written instructions;</text> </paragraph> <paragraph num="(iii)"> <text>By telephone or other electronic means; or</text> </paragraph> <paragraph num="(iv)"> <text>By designation of one or more supervisors in the absence of the supervisor of record as defined in Regulations .13—.16 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Trauma informed care” means including in treatment an approach that:</text> <paragraph num="(a)"> <text>Engages people with histories of physical, sexual, emotional, or mental trauma in a manner that recognizes the:</text> <paragraph num="(i)"> <text>Presence of a trauma history;</text> </paragraph> <paragraph num="(ii)"> <text>Consequences of the trauma; and</text> </paragraph> <paragraph num="(iii)"> <text>Neurological, biological, psychological, and social effects of trauma for the affected individual; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Addresses the vulnerabilities or triggers for these individuals while minimizing any harm.</text> </paragraph> </paragraph> <paragraph num="(31)"> <text>“Under the supervision of an approved alcohol and drug counselor supervisor” means:</text> <paragraph num="(a)"> <text>Engaging in an ongoing process that includes direct, on-site, face-to-face individual or group meetings focused on quality of delivery of alcohol and drug counseling services;</text> </paragraph> <paragraph num="(b)"> <text>Monitoring the performance of a:</text> <paragraph num="(i)"> <text>Licensed graduate alcohol and drug counselor</text> </paragraph> <paragraph num="(ii)"> <text>Certified associate counselor-alcohol and drug;</text> </paragraph> <paragraph num="(iii)"> <text>Certified supervised counselor-alcohol and drug; or</text> </paragraph> <paragraph num="(iv)"> <text>Alcohol and drug trainee;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Providing documented and direct consultation, guidance, and instruction with respect to clinical skill and competency; and</text> </paragraph> <paragraph num="(d)"> <text>Improving counseling skills for a minimum of:</text> <paragraph num="(i)"> <text>1 documented hour for each 40-hour work week; or</text> </paragraph> <paragraph num="(ii)"> <text>Not less than 2 documented hours per month for less than a 40-hour work week.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Written contract for supervision” means a Board-approved agreement between the supervisee and approved alcohol and drug supervisor that is initiated before beginning supervision and that details the scope of supervision and includes at a minimum the following:</text> <paragraph num="(a)"> <text>Name and credentials of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(b)"> <text>Primary purpose, goals, and objectives of the supervision process;</text> </paragraph> <paragraph num="(c)"> <text>Details of provisions, including frequency, format, and case or chart review;</text> </paragraph> <paragraph num="(d)"> <text>Methods of documentation;</text> </paragraph> <paragraph num="(e)"> <text>Duties and responsibilities of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(f)"> <text>Procedural considerations in the case of the supervisor’s absence; and</text> </paragraph> <paragraph num="(g)"> <text>Information regarding the supervisor’s scope of competence.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Process for Certification, Licensure, and Trainee Status."> <paragraph num="A."> <text>In order to obtain a certificate or license or to be eligible for trainee status, an applicant shall:</text> <paragraph num="(1)"> <text>Complete and return the Board-approved application;</text> </paragraph> <paragraph num="(2)"> <text>Submit an official transcript from an accredited educational institution indicating the:</text> <paragraph num="(a)"> <text>Completion of the highest degree attained; and</text> </paragraph> <paragraph num="(b)"> <text>Course work required for:</text> <paragraph num="(i)"> <text>Licensure;</text> </paragraph> <paragraph num="(ii)"> <text>Certification; or</text> </paragraph> <paragraph num="(iii)"> <text>Trainee status;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pay all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(4)"> <text>Submit to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(6)"> <text>Be at least 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applications shall be acted upon as follows:</text> <paragraph num="(1)"> <text>Within 30 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice, the applicant shall correct the deficiency within 90 days, or other period specified in the notice;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the Board determines that an applicant is eligible to take the required examinations, the Board shall send a notice of approval to the applicant;</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of the approval notice, the applicant shall have 1 year from the date of the notice to take the examinations; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant fails to take the examinations within 1 year from the date of the approval notice, the requirements set forth under §B(4) of this regulation shall apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensed Graduate Alcohol and Drug Counselors."> <paragraph num="A."> <text>Scope of Practice. The scope of practice for a licensed graduate alcohol and drug counselor includes the following activities to be performed under the clinical supervision of an approved alcohol and drug counselor supervisor:</text> <paragraph num="(1)"> <text>Clinical evaluation, including screening, assessment, and diagnosis for mental health disorders;</text> </paragraph> <paragraph num="(2)"> <text>Treatment planning for mental health disorders, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention;</text> </paragraph> <paragraph num="(3)"> <text>Referral;</text> </paragraph> <paragraph num="(4)"> <text>Service coordination and case management;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, therapy, and trauma informed care with individuals, couples, families and groups;</text> </paragraph> <paragraph num="(6)"> <text>Client, family, and community education;</text> </paragraph> <paragraph num="(7)"> <text>Documentation; and</text> </paragraph> <paragraph num="(8)"> <text>Professional and ethical responsibilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure. To qualify for licensure as a graduate alcohol and drug counselor, an applicant shall have:</text> <paragraph num="(1)"> <text>Completed one of the following from an accredited educational institution:</text> <paragraph num="(a)"> <text>A master’s degree in a health and human services counseling field with:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>90 graduate quarter credit hours;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A doctoral degree in a health and human services counseling field with:</text> <paragraph num="(i)"> <text>A minimum of 90 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>135 graduate quarter credit hours; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A master’s degree and have completed a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 60 credit hours in counseling, including the required alcohol and drug course work for the license, as specified in §B(2) and (4) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 39 semester credit hours or 65 quarter credit hours in alcohol and drug counselor training from an accredited educational institution including:</text> <paragraph num="(a)"> <text>3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Pharmacology;</text> </paragraph> <paragraph num="(ii)"> <text>Group counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(iv)"> <text>Addictions treatment delivery;</text> </paragraph> <paragraph num="(v)"> <text>Ethics that include alcohol and drug counseling issues; and</text> </paragraph> <paragraph num="(vi)"> <text>Abnormal psychology; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any three of the following 3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Human development;</text> </paragraph> <paragraph num="(ii)"> <text>Theories of counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Treatment of co-occurring disorders;</text> </paragraph> <paragraph num="(iv)"> <text>Topics in substance-related and addictive disorders; or</text> </paragraph> <paragraph num="(v)"> <text>Family counseling;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completed one of the following:</text> <paragraph num="(a)"> <text>An internship in alcohol and drug counseling that totals 6 semester credit hours or 10 quarter credit hours; or</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 1,000 hours of alcohol and drug counseling work completed as a certified associate counselor-alcohol and drug, a certified supervised counselor-alcohol and drug, or an alcohol and drug trainee under and verified by an approved alcohol and drug counselor supervisor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Completed a minimum of 3 graduate semester credit hours or 5 quarter credit hours in each of the following course content areas:</text> <paragraph num="(a)"> <text>Diagnosis and psychopathology; and</text> </paragraph> <paragraph num="(b)"> <text>Psychotherapy and treatment of mental and emotional disorders;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Licensed graduate alcohol and drug counselors shall have available for inspection a professional disclosure statement, as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states that the counseling services are provided under supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name, title, and credentials of the supervisor of record, including the supervisor’s address and contact information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reexamination. An applicant who fails an examination for licensure:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="F."> <text>A licensed graduate alcohol and drug counselor may not:</text> <paragraph num="(1)"> <text>Practice independently; or</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Expiration and Extension.</text> <paragraph num="(1)"> <text>The graduate alcohol and drug counselor license expires 2 years after the date issued.</text> </paragraph> <paragraph num="(2)"> <text>If the graduate alcohol and drug counselor licensee is unable to accumulate the required clinical hours for licensure as a clinical alcohol and drug counselor in 2 years, the graduate alcohol and drug counselor may apply on a Board-approved form for a 2-year extension before the current license as a graduate alcohol and drug counselor expires, up to a maximum of 6 years, except as provided in §G(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>For the graduate alcohol and drug counselor who has been granted a 2-year extension, CEUs are not required for the first 2-year extension. Subsequent extensions approved by the Board shall be subject to the continuing education requirements in COMAR 10.58.05.</text> </paragraph> <paragraph num="(4)"> <text>A graduate alcohol and drug counselor shall submit a written request for an extension beyond the 6-year maximum, which the Board may grant in certain circumstances.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the license renewal date, the Board may reinstate the license of a licensed graduate alcohol and drug counselor otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes the required CEUs as set forth under COMAR 10.58.05;</text> </paragraph> <paragraph num="(b)"> <text>Meets the current licensure requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Pays the reinstatement fee as set forth under COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and .06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed graduate alcohol and drug counselor whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice clinical alcohol and drug counseling.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §17-505, Annotated Code of Maryland, a request to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(a)"> <text>Completed Board-approved application; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of all applicable fees set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual may apply for inactive status only if the individual’s license is still active at the time application for inactive status is made.</text> </paragraph> <paragraph num="(3)"> <text>An individual on inactive status is not authorized to practice graduate alcohol and drug counseling.</text> </paragraph> <paragraph num="(4)"> <text>Within 5 calendar years after being placed on inactive status, an individual on inactive status seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed the CEU requirements as set forth under COMAR 10.58.05.</text> </paragraph> <paragraph num="(5)"> <text>If an individual on inactive status seeks to be reinstated beyond the required 5-year period and the conditions set forth under §I(4) of this regulation, the individual shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application;</text> </paragraph> <paragraph num="(b)"> <text>Meet the current licensure requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensed Clinical Alcohol and Drug Counselors."> <paragraph num="A."> <text>Scope of Practice. The scope of practice of a licensed clinical alcohol and drug counselor includes the following activities:</text> <paragraph num="(1)"> <text>Clinical evaluation, including screening, assessment, and diagnosis for mental health disorders;</text> </paragraph> <paragraph num="(2)"> <text>Treatment planning for mental health and substance use disorders, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention;</text> </paragraph> <paragraph num="(3)"> <text>Referral;</text> </paragraph> <paragraph num="(4)"> <text>Service coordination and case management;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, therapy, and trauma-informed care with individuals, couples, families, and groups;</text> </paragraph> <paragraph num="(6)"> <text>Client, family, and community education;</text> </paragraph> <paragraph num="(7)"> <text>Documentation;</text> </paragraph> <paragraph num="(8)"> <text>Professional and ethical responsibilities; and</text> </paragraph> <paragraph num="(9)"> <text>Supervisory responsibilities for all categories of licensed and certified alcohol and drug counselors or trainees.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Licensure. To qualify for licensure as a clinical alcohol and drug counselor, the applicant shall have:</text> <paragraph num="(1)"> <text>Completed one of the following from an accredited educational institution:</text> <paragraph num="(a)"> <text>A master’s degree in a health and human services counseling field with:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>90 quarter credit hours;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A doctoral degree in a health and human services counseling field with:</text> <paragraph num="(i)"> <text>A minimum of 90 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>135 graduate quarter credit hours; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A master’s degree and have completed a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 60 credit hours in counseling, including the required alcohol and drug course work for the license, as specified in §B(2) and (4) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 39 semester credit hours or 65 quarter credit hours in alcohol and drug counselor training from an accredited educational institution with at least 3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(a)"> <text>Pharmacology;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(d)"> <text>Addictions treatment delivery;</text> </paragraph> <paragraph num="(e)"> <text>Ethics that include alcohol and drug counseling issues;</text> </paragraph> <paragraph num="(f)"> <text>Human development;</text> </paragraph> <paragraph num="(g)"> <text>Abnormal psychology;</text> </paragraph> <paragraph num="(h)"> <text>Theories of counseling;</text> </paragraph> <paragraph num="(i)"> <text>Treatment of co-occurring disorders;</text> </paragraph> <paragraph num="(j)"> <text>Topics in substance-related and addictive disorders; and</text> </paragraph> <paragraph num="(k)"> <text>Family counseling;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completed one of the following:</text> <paragraph num="(a)"> <text>An internship in alcohol and drug counseling that totals 6 semester credit hours or 10 quarter credit hours; or</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 1,000 hours of alcohol and drug counseling work completed as a licensed graduate alcohol and drug counselor, a certified associate counselor-alcohol and drug, a certified supervised counselor-alcohol and drug, or an alcohol and drug trainee under and verified by an approved alcohol and drug counselor supervisor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Completed a minimum of 3 graduate semester credit hours or 5 quarter credit hours in each of the following content areas:</text> <paragraph num="(a)"> <text>Diagnosis and psychopathology; and</text> </paragraph> <paragraph num="(b)"> <text>Psychotherapy and treatment of mental and emotional disorders;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Completed a minimum of 2 years and 2,000 hours of supervised clinical experience in alcohol and drug counseling:</text> <paragraph num="(a)"> <text>Obtained after the awarding of a master’s or doctoral degree;</text> </paragraph> <paragraph num="(b)"> <text>As a supervisee, as defined under Regulation .02B of this chapter, under an approved alcohol and drug counselor supervisor; and</text> </paragraph> <paragraph num="(c)"> <text>Of which a minimum of 1,500 hours shall be direct clinical counseling services, including 100 hours of clinical supervision, of which:</text> <paragraph num="(i)"> <text>A minimum of 50 hours shall be individual face-to-face clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>A maximum of 50 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew clinical alcohol and drug counselor licensure, the applicant, before the current license expiration, shall:</text> <paragraph num="(a)"> <text>Complete a Board-approved renewal application;</text> </paragraph> <paragraph num="(b)"> <text>Pay all applicable fees set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed clinical alcohol and drug counselor shall comply with the renewal requirements as provided in Health Occupations Article, §17–504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to renew licensure is not authorized to and may not practice clinical alcohol and drug counseling.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Reinstatement. The Board may reinstate the license of a licensed clinical alcohol and drug counselor as set forth under Regulation .04H of this chapter.</text> </paragraph> <paragraph num="E."> <text>Inactive Status. A licensed clinical alcohol and drug counselor may request inactive status as set forth under Regulation .04I of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Certified Professional Counselor-Alcohol and Drug."> <paragraph num="A."> <text>The scope of practice for a certified professional counselor-alcohol and drug consists of the following activities:</text> <paragraph num="(1)"> <text>Biopsychosocial evaluation, including screening, assessment, and participating in the development of diagnostic impressions for SUDs and CODs;</text> </paragraph> <paragraph num="(2)"> <text>Treatment planning for SUDs and CODs, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention;</text> </paragraph> <paragraph num="(3)"> <text>Referral;</text> </paragraph> <paragraph num="(4)"> <text>Service coordination and case management in the areas of SUDs and CODs;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, therapy, and trauma-informed care with individuals, families, and groups in the areas of SUDs and CODs;</text> </paragraph> <paragraph num="(6)"> <text>Client, family, and community education;</text> </paragraph> <paragraph num="(7)"> <text>Documentation;</text> </paragraph> <paragraph num="(8)"> <text>Professional and ethical responsibilities; and</text> </paragraph> <paragraph num="(9)"> <text>Supervisory responsibilities for all categories of certified alcohol and drug counselors or trainees in the certification track.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew certified professional counselor-alcohol and drug certification, the applicant, before the current certificate expiration, shall:</text> <paragraph num="(a)"> <text>Complete an application on a form approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required application fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not renew the certification of any certified professional counselor-alcohol and drug who fails to complete all requirements for renewal before the expiration date of the current certification.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not reinstate the certification of a certified professional counselor-alcohol and drug who has failed to renew for any reason.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Certified Associate Counselor-Alcohol and Drug."> <paragraph num="A."> <text>Scope of Practice. The scope of practice of a certified associate counselor-alcohol and drug consists of the following activities, performed in accordance with §B of this regulation:</text> <paragraph num="(1)"> <text>Biopsychosocial evaluation, including participating in the development of diagnostic impressions for SUDs or Screening, Brief Intervention, and Referral to Treatment (SBIRT);</text> </paragraph> <paragraph num="(2)"> <text>Treatment planning for SUDs and CODs, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention;</text> </paragraph> <paragraph num="(3)"> <text>Referral;</text> </paragraph> <paragraph num="(4)"> <text>Service coordination and case management for SUDs and CODs;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, therapy, and trauma informed care, with individuals, couples, families, and groups;</text> </paragraph> <paragraph num="(6)"> <text>Client, family, and community education;</text> </paragraph> <paragraph num="(7)"> <text>Documentation; and</text> </paragraph> <paragraph num="(8)"> <text>Complying with:</text> <paragraph num="(a)"> <text>Professional and ethical responsibilities; and</text> </paragraph> <paragraph num="(b)"> <text>Supervisory responsibilities for a certified associate counselor-alcohol and drug, certified supervised counselor-alcohol and drug, or a trainee seeking certification, provided that the certified associate counselor-alcohol and drug has been approved as a supervisor by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A certified associate counselor-alcohol and drug:</text> <paragraph num="(1)"> <text>Shall provide alcohol and drug counseling:</text> <paragraph num="(a)"> <text>As an employee of an agency or facility that is certified or licensed by the State; and</text> </paragraph> <paragraph num="(b)"> <text>Under the moderate supervision of an approved alcohol and drug counselor supervisor as specified in Health Occupations Article, §17–403, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>May provide supervision with approval by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>May not practice independently.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To qualify for certification as a certified associate counselor-alcohol and drug (CAC-AD) an applicant shall have:</text> <paragraph num="(1)"> <text>At a minimum:</text> <paragraph num="(a)"> <text>A bachelor’s degree from an accredited educational institution in a health and human services counseling field; or</text> </paragraph> <paragraph num="(b)"> <text>A bachelor’s degree and have completed a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 45 credit hours in counseling, including the required alcohol and drug course work for the level of certification sought, as specified in §C(2) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 33 semester credit hours or 50 quarter credit hours in alcohol and drug counselor training from an accredited educational institution including:</text> <paragraph num="(a)"> <text>3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Pharmacology;</text> </paragraph> <paragraph num="(ii)"> <text>Group counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(iv)"> <text>Addictions treatment delivery;</text> </paragraph> <paragraph num="(v)"> <text>Ethics that includes alcohol and drug counseling issues; and</text> </paragraph> <paragraph num="(vi)"> <text>Abnormal psychology; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any three of the following 3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Human development;</text> </paragraph> <paragraph num="(ii)"> <text>Theories of counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Treatment of co-occurring disorders;</text> </paragraph> <paragraph num="(iv)"> <text>Topics in substance-related and addictive disorders; and</text> </paragraph> <paragraph num="(v)"> <text>Family counseling;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completed one of the following:</text> <paragraph num="(a)"> <text>An internship in alcohol and drug counseling that totals 6 semester credit hours or 10 quarter credit hours; or</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 1,000 hours of alcohol and drug counseling work completed as a certified associate counselor-alcohol and drug, a certified supervised counselor-alcohol and drug, or an alcohol and drug trainee under and verified by an approved alcohol and drug counselor supervisor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Completed not less than 1 year with a minimum of 1,000 hours of clinically supervised experience in alcohol and drug counseling completed as a certified supervised counselor-alcohol and drug or an alcohol and drug trainee under and verified by an approved alcohol and drug counselor supervisor;</text> </paragraph> <paragraph num="(5)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination as approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Certified associate counselors-alcohol and drug shall have available for inspection a professional disclosure statement, as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states that the counseling services are provided under supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name, title, and credentials of the supervisor of record, including the supervisor’s address and contact information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reexamination. An applicant who fails an examination for certification:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to submit a new application and pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="G."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew the certification of a certified associate counselor-alcohol and drug, the applicant, before the current certificate expiration, shall:</text> <paragraph num="(a)"> <text>Complete a Board-approved renewal application;</text> </paragraph> <paragraph num="(b)"> <text>Pay all applicable fees set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may not renew the certification of any certified associate counselor — alcohol and drug who fails to complete all requirements for renewal before the expiration date of the current certification.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to renew certification is not authorized to and may not practice alcohol and drug counseling.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the certificate renewal date, the Board may reinstate the certificate of a certified associate counselor-alcohol and drug otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose certificate was not renewed for any reason, if the certificate holder:</text> <paragraph num="(a)"> <text>Completes the required CEUs as set forth under COMAR 10.58.05;</text> </paragraph> <paragraph num="(b)"> <text>Meets the current certification requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Pays the reinstatement fee as set forth under COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and .06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any certified associate counselor-alcohol and drug whose certificate has expired more than 5 calendar years before the request for reinstatement, a new application for certification shall be completed and the current certification requirements shall be met.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §17-505, Annotated Code of Maryland, a request to transfer a certificate to inactive status shall be granted upon receipt of the:</text> <paragraph num="(a)"> <text>Completed Board-approved application; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of all applicable fees set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual may apply for inactive status only if the individual’s certificate is active at the time application for inactive status is made.</text> </paragraph> <paragraph num="(3)"> <text>An individual on inactive status is not authorized to practice alcohol and drug counseling.</text> </paragraph> <paragraph num="(4)"> <text>Within 5 calendar years after being placed on inactive status, an individual on inactive status seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed the CEU requirements as set forth under COMAR 10.58.05.</text> </paragraph> <paragraph num="(5)"> <text>If an individual on inactive status seeks to be reinstated beyond the required 5-year period and conditions set forth under §I(4) of this regulation, the individual shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application;</text> </paragraph> <paragraph num="(b)"> <text>Meet the current certification requirements; and</text> </paragraph> <paragraph num="(c)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Certified Supervised Counselor-Alcohol and Drug."> <paragraph num="A."> <text>Scope of Practice. The scope of practice for a certified supervised counselor-alcohol and drug consists of the following activities, performed in accordance with §B of this regulation:</text> <paragraph num="(1)"> <text>Participating in the development of diagnostic impressions for SUDs and CODs, as:</text> <paragraph num="(a)"> <text>Confirmed by an approved alcohol and drug counselor supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>Documented by signature and credentials;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Biopsychosocial evaluation, as permitted by the Board-approved supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Screening, Brief Intervention, and Referral to Treatment (SBIRT);</text> </paragraph> <paragraph num="(4)"> <text>Treatment planning for SUDs and CODs, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention, as confirmed by:</text> <paragraph num="(a)"> <text>An approved alcohol and drug counselor supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation by signature and credentials;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Referral;</text> </paragraph> <paragraph num="(6)"> <text>Participating in service coordination, case coordination, and case management for SUDs and CODs;</text> </paragraph> <paragraph num="(7)"> <text>Counseling of individuals and groups for SUDs;</text> </paragraph> <paragraph num="(8)"> <text>Client, family, and community education for SUDs;</text> </paragraph> <paragraph num="(9)"> <text>Documentation; and</text> </paragraph> <paragraph num="(10)"> <text>Complying with the professional and ethical responsibilities set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A certified supervised counselor-alcohol and drug:</text> <paragraph num="(1)"> <text>Shall practice under the close supervision of an approved alcohol and drug counselor supervisor;</text> </paragraph> <paragraph num="(2)"> <text>Shall provide alcohol and drug counseling as an employee of an agency or facility that is certified or licensed by the State; and</text> </paragraph> <paragraph num="(3)"> <text>May not:</text> <paragraph num="(a)"> <text>Provide supervision; or</text> </paragraph> <paragraph num="(b)"> <text>Practice independently.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>To qualify for certification as a supervised counselor-alcohol and drug, an applicant shall have:</text> <paragraph num="(1)"> <text>At a minimum:</text> <paragraph num="(a)"> <text>An associate’s degree from an accredited educational institution in a health and human services counseling field; or</text> </paragraph> <paragraph num="(b)"> <text>An associate’s degree and have completed a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 30 credit hours in counseling, including the required alcohol and drug course work for the level of certification sought, as specified in §C of this regulation;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 24 semester credit hours or 37 quarter credit hours in alcohol and drug counselor training from an accredited educational institution including:</text> <paragraph num="(a)"> <text>3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Pharmacology;</text> </paragraph> <paragraph num="(ii)"> <text>Addictions treatment delivery; and</text> </paragraph> <paragraph num="(iii)"> <text>Ethics that includes alcohol and drug counseling issues; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Any three of the following 3 semester credit hours or 5 quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(i)"> <text>Human development;</text> </paragraph> <paragraph num="(ii)"> <text>Theories of counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Treatment of co-occurring disorders;</text> </paragraph> <paragraph num="(iv)"> <text>Family counseling;</text> </paragraph> <paragraph num="(v)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(vi)"> <text>Group counseling;</text> </paragraph> <paragraph num="(vii)"> <text>Abnormal psychology; and</text> </paragraph> <paragraph num="(viii)"> <text>Topics in substance-related and addictive disorders;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Completed one of the following:</text> <paragraph num="(a)"> <text>An internship in alcohol and drug counseling that totals 6 semester credit hours or 10 quarter credit hours; or</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 1,000 hours of alcohol and drug counseling work completed as an alcohol and drug trainee under and verified by an approved alcohol and drug counselor supervisor;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination as approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Certified supervised counselors-alcohol and drug shall have available for inspection a professional disclosure statement, as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states that the counseling services are provided under supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name, title, and credentials of the supervisor of record, including the supervisor’s address and contact information.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reexamination. An applicant who fails an examination for certification:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="G."> <text>Renewal. The Board may renew the certificate of a certified supervised counselor-alcohol and drug as set forth under Regulation .07G in this chapter.</text> </paragraph> <paragraph num="H."> <text>Reinstatement. The Board may reinstate the certificate of a certified supervised counselor-alcohol and drug as set forth under Regulation .07H in this chapter.</text> </paragraph> <paragraph num="I."> <text>Inactive Status. A certified supervised counselor-alcohol and drug may request inactive status as set forth under Regulation .07I of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Alcohol and Drug Trainees."> <paragraph num="A."> <text>Scope of Practice. The scope of practice of an alcohol and drug trainee shall be limited to the following activities under an approved alcohol and drug counselor supervisor:</text> <paragraph num="(1)"> <text>Biopsychosocial evaluation, including screening, assessment, and diagnostic impressions for SUDs and CODs;</text> </paragraph> <paragraph num="(2)"> <text>Treatment planning for SUDs and CODs, including initial, ongoing, continuity of care, discharge, and planning for relapse prevention;</text> </paragraph> <paragraph num="(3)"> <text>Referral;</text> </paragraph> <paragraph num="(4)"> <text>Service coordination and case management in the areas of SUDs and CODs;</text> </paragraph> <paragraph num="(5)"> <text>Counseling, therapy, and trauma informed care with individuals, couples, families and groups in the areas of SUDs and CODs;</text> </paragraph> <paragraph num="(6)"> <text>Client, family, group, and community education;</text> </paragraph> <paragraph num="(7)"> <text>Documentation; and</text> </paragraph> <paragraph num="(8)"> <text>Compliance with professional and ethical responsibilities.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A trainee may not perform supervision.</text> </paragraph> <paragraph num="C."> <text>Qualifications. To qualify as an alcohol and drug trainee, an applicant shall meet one of the following requirements:</text> <paragraph num="(1)"> <text>Hold an associate’s degree or higher from an accredited educational institution:</text> <paragraph num="(a)"> <text>In a health and human services counseling field; or</text> </paragraph> <paragraph num="(b)"> <text>Hold an associate’s degree and a completed program of studies determined by the Board to be substantially equivalent in subject matter, which includes 1 semester credit hour or 2 quarter credit hours in the ethics of alcohol and drug counseling; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have completed 15 semester credit hours or 25 quarter credit hours from among the topic areas specified in Regulation .05B of this chapter including:</text> <paragraph num="(a)"> <text>15 continuing education units (CEUs) in the ethics of alcohol and drug counseling; or</text> </paragraph> <paragraph num="(b)"> <text>1 semester credit hour or 2 quarter credit hours in the ethics of alcohol and drug counseling from an accredited educational institution.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>An alcohol and drug trainee shall:</text> <paragraph num="(1)"> <text>Practice under the supervision of a Board-approved alcohol and drug supervisor as specified under §§E—H of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Have available for inspection a professional disclosure statement, as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(a)"> <text>Clearly states that the counseling services are provided under supervision; and</text> </paragraph> <paragraph num="(b)"> <text>Provides the name, title, and credentials of the supervisor of record, including the supervisor’s address and contact information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>A trainee holding a master’s degree shall:</text> <paragraph num="(1)"> <text>Practice under the clinical supervision of an approved alcohol and drug counselor supervisor as defined under Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Provide alcohol and drug counseling as an employee of an agency or facility that is certified or licensed by the State; and</text> </paragraph> <paragraph num="(3)"> <text>Provide documentation satisfactory to the Board every 2 years of progress towards the fulfillment of the experiential and course of study requirements under Health Occupations Article, §17-302, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A trainee holding a bachelor’s degree shall:</text> <paragraph num="(1)"> <text>Practice under the moderate supervision of an approved alcohol and drug counselor supervisor;</text> </paragraph> <paragraph num="(2)"> <text>Provide alcohol and drug counseling as an employee of an agency or facility that is certified or licensed by the State; and</text> </paragraph> <paragraph num="(3)"> <text>Provide documentation satisfactory to the Board every 2 years of progress towards the fulfillment of the experiential and course of study requirements under Health Occupations Article, §17-403 or 17-404, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>A trainee holding an associate’s degree shall:</text> <paragraph num="(1)"> <text>Practice under the close supervision of an approved alcohol and drug counselor supervisor;</text> </paragraph> <paragraph num="(2)"> <text>Provide alcohol and drug counseling as an employee of an agency or facility that is certified or licensed by the State; and</text> </paragraph> <paragraph num="(3)"> <text>Provide documentation satisfactory to the Board every 2 years of progress towards the fulfillment of the experiential and course of study requirements under Health Occupations Article, §17-403 or 17-404, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="H."> <text>A trainee holding a high school diploma shall meet all guidelines set forth under §G of this regulation.</text> </paragraph> <paragraph num="I."> <text>Application Process.</text> <paragraph num="(1)"> <text>To qualify for alcohol and drug trainee status, an applicant shall:</text> <paragraph num="(a)"> <text>Complete and return the Board-approved application that includes:</text> <paragraph num="(i)"> <text>Information and supporting documentation regarding the applicant’s current educational level at the start of the trainee period; and</text> </paragraph> <paragraph num="(ii)"> <text>An attestation specifying the certification or licensure level being sought at the end of the trainee period;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Meet all of the requirements set forth under Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Provide the name and credentials of the applicant’s prospective supervisor before beginning practice; and</text> </paragraph> <paragraph num="(d)"> <text>Comply with:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The trainee shall notify the Board in writing within 30 days of any changes in employment and supervision.</text> </paragraph> <paragraph num="(3)"> <text>An individual licensed as a clinical mental healthcare provider under the Health Occupations Article, Title 17, Annotated Code of Maryland, may not apply as a trainee.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Trainee Practice of Alcohol and Drug Counseling.</text> <paragraph num="(1)"> <text>An individual may practice alcohol and drug counseling as a trainee for a maximum of 6 years.</text> </paragraph> <paragraph num="(2)"> <text>After fulfilling the experiential and course of study requirements under Regulations .04, .05, .07, or .08 of this chapter, the alcohol and drug trainee may be eligible to apply for:</text> <paragraph num="(a)"> <text>Licensed clinical alcohol and drug counselor (LCADC);</text> </paragraph> <paragraph num="(b)"> <text>Licensed graduate alcohol and drug counselor (LGADC);</text> </paragraph> <paragraph num="(c)"> <text>Certified associate counselor-alcohol and drug (CAC—AD); or</text> </paragraph> <paragraph num="(d)"> <text>Certified supervised counselor-alcohol and drug (CSC—AD).</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Renewal.</text> <paragraph num="(1)"> <text>The Board shall issue a letter to the individual authorizing the individual to practice alcohol and drug counseling as a trainee for 2 years, renewable in 2-year increments up to a total of 6 years.</text> </paragraph> <paragraph num="(2)"> <text>In each 2-year renewal application, before the expiration of the current trainee period, the trainee shall:</text> <paragraph num="(a)"> <text>Document progress made during the current 2-year period towards the stated educational and supervised clinical experience required for the licensure or certification sought at the end of the trainee period, including:</text> <paragraph num="(i)"> <text>A verification from the approved alcohol and drug supervisor documenting the number of hours of supervised clinical experience obtained during the 2-year period; and</text> </paragraph> <paragraph num="(ii)"> <text>A copy of an official transcript from an educational institution approved by the Board documenting progress made in completing the required education;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Submit a completed Board-approved trainee renewal application;</text> </paragraph> <paragraph num="(c)"> <text>Pay the required renewal fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(d)"> <text>Provide documentation, satisfactory to the Board, every 2 years of the applicant’s progress towards fulfilling the experiential and course of study requirements under Health Occupations Article, §17-403 or 17-404, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board may deny renewal if the applicant fails to document sufficient progress as determined by the Board.</text> </paragraph> <paragraph num="(4)"> <text>A trainee who fails to renew their trainee status is not authorized to practice alcohol and drug counseling.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Licensure Eligibility: Out-of-State Applicants."> <paragraph num="A."> <text>An applicant licensed as a clinical alcohol and drug counselor or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for licensure if the applicant:</text> <paragraph num="(1)"> <text>Provides:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Documentation or transcripts confirming completion of one of the following from an accredited educational institution:</text> <paragraph num="(i)"> <text>A master’s or doctoral degree in a health and human services counseling field; or</text> </paragraph> <paragraph num="(ii)"> <text>A master’s degree and confirmation of the completion of a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 60 credit hours in counseling, including the required alcohol and drug course work for the license, as specified in Regulation .04B of this chapter;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A copy of a current license from each state, territory, or jurisdiction in which the applicant has been licensed, registered, or otherwise authorized to practice alcohol and drug counseling;</text> </paragraph> <paragraph num="(d)"> <text>Documentation, satisfactory to the Board, that the applicant is currently licensed in good standing to practice alcohol and drug counseling in another state, territory, or jurisdiction; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the applicant has:</text> <paragraph num="(i)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a license to practice clinical alcohol and drug counseling; and</text> </paragraph> <paragraph num="(ii)"> <text>Not committed any act or omission that would be grounds for discipline or denial of licensure under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in the COMAR 10.58.02;</text> </paragraph> <paragraph num="(3)"> <text>Has achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Meets all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Complies with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board may waive any examination requirements for an applicant who satisfies the Board that the applicant:</text> <paragraph num="(1)"> <text>Obtained licensure in a state or country that grants a similar endorsement to license holders of this State;</text> </paragraph> <paragraph num="(2)"> <text>Became licensed in another state or country after passing an examination approved by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Meets the qualifications otherwise required by Health Occupations Article, Title 17, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Educational Requirements. The educational requirements for licensure in this State as a clinical alcohol and drug counselor shall be met:</text> <paragraph num="(1)"> <text>As established in Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>By providing documentation of the substitute educational and experience requirements outlined in §§D and E of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Waiver of Course Requirements. The Board may waive one or more course requirements specified in Regulation .04B of this chapter, except for documentation or transcripts showing completion of:</text> <paragraph num="(1)"> <text>3 graduate semester credit hours or 5 graduate quarter credit hours covering the following primary topics or content areas:</text> <paragraph num="(a)"> <text>Psychotherapy and treatment of mental and emotional disorders, as described in Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Diagnosis and psychopathology; and</text> </paragraph> <paragraph num="(c)"> <text>Professional, legal, and ethical responsibilities; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>3 undergraduate semester credit hours or 5 undergraduate quarter credit hours in:</text> <paragraph num="(a)"> <text>The ethics of alcohol and drug counseling; and</text> </paragraph> <paragraph num="(b)"> <text>Pharmacology.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Equivalent Experience Requirements.</text> <paragraph num="(1)"> <text>The applicant shall provide documentation, satisfactory to the Board, of one of the following for an applicant with:</text> <paragraph num="(a)"> <text>A master’s degree consisting of:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate credit hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Not less than 3 years, with a minimum of 2,000 hours, of supervised clinical experience in alcohol and drug counseling, 2 years of which shall be completed after the award of the master’s degree;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A master’s degree consisting of:</text> <paragraph num="(i)"> <text>Less than 60 graduate credit hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Not less than 3 years of experience practicing as a clinical alcohol and drug counselor, with a minimum of 2,000 hours of clinical alcohol and drug counseling experience; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A doctoral degree consisting of:</text> <paragraph num="(i)"> <text>Not less than 2 years practicing as a clinical alcohol and drug counselor; or</text> </paragraph> <paragraph num="(ii)"> <text>A minimum of 2,000 hours of clinical alcohol and drug counseling experience.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The applicant shall provide verification, on a Board-approved form, from employers, supervisors, or colleagues that the applicant has practiced clinical alcohol and drug counseling for the length of time stated in §E(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Certification Eligibility — CAC-AD — Out-of-State Applicants."> <paragraph num="A."> <text>An applicant certified as a certified associate counselor-alcohol and drug or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for certification if the applicant:</text> <paragraph num="(1)"> <text>Provides:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Documentation or transcripts confirming completion of one of the following from an accredited educational institution:</text> <paragraph num="(i)"> <text>A bachelor’s degree in a health and human services counseling field; or</text> </paragraph> <paragraph num="(ii)"> <text>A bachelor’s degree and confirmation of the completion of a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 45 credit hours in counseling, including the required alcohol and drug course work for the certificate, as specified in Regulations .07 and .08 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A copy of a current certification from each state, territory, or jurisdiction, in which the applicant has been certified or otherwise authorized to practice alcohol and drug counseling;</text> </paragraph> <paragraph num="(d)"> <text>Documentation, satisfactory to the Board, that the applicant is currently certified in good standing to practice alcohol and drug counseling in another state, territory, or jurisdiction; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the applicant has:</text> <paragraph num="(i)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a certificate to practice alcohol and drug counseling; and</text> </paragraph> <paragraph num="(ii)"> <text>Not committed any act or omission that would be grounds for discipline or denial of certification under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in the COMAR 10.58.02;</text> </paragraph> <paragraph num="(3)"> <text>Has achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Meets all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Complies with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board may waive any examination requirements for an applicant who satisfies the Board that the applicant:</text> <paragraph num="(1)"> <text>Obtained certification in a state or country that grants a similar endorsement to certificate holders of this State;</text> </paragraph> <paragraph num="(2)"> <text>Became certified in another state or country after passing an examination approved by the Board;</text> </paragraph> <paragraph num="(3)"> <text>Meets the qualifications otherwise required by Health Occupations Article, Title 17, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Educational Requirements. The educational requirements for certification in this State as a certified associate counselor-alcohol and drug shall be met:</text> <paragraph num="(1)"> <text>As established in Regulation .07 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>By providing documentation of the substitute educational and experience requirements outlined in §§D and E of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Waiver of Course Requirements. The Board may waive one or more course requirements specified in Regulations .04B and .05B of this chapter, except for documentation showing completion of:</text> <paragraph num="(1)"> <text>12 continuing education units (CEUs) in the ethics of alcohol and drug counseling; or</text> </paragraph> <paragraph num="(2)"> <text>1 semester credit hour or 2 quarter credit hours in the ethics of alcohol and drug counseling.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Equivalent Experience Requirements. The applicant shall provide:</text> <paragraph num="(1)"> <text>Documentation, satisfactory to the Board, of not less than 2 years of supervised clinical experience in alcohol and drug counseling with a minimum of 2,000 hours experience; and</text> </paragraph> <paragraph num="(2)"> <text>Verification, on a Board-approved form, from employers, supervisors, or colleagues that the applicant has practiced alcohol and drug counseling for the length of time stated in §E(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Certification Eligibility — CSC-AD — Out-of-State Applicants."> <paragraph num="A."> <text>An applicant certified as a certified supervised counselor-alcohol and drug or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for certification if the applicant:</text> <paragraph num="(1)"> <text>Provides:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Documentation or transcripts confirming completion of one of the following from an accredited educational institution:</text> <paragraph num="(i)"> <text>An associate’s degree in a health and human services counseling field; or</text> </paragraph> <paragraph num="(ii)"> <text>An associate’s degree and confirmation of the completion of a program of studies determined by the Board to be substantially equivalent in subject matter with a minimum of 30 credit hours in counseling, including the required alcohol and drug course work for the certificate, as specified in Regulations .07 and .08 of this chapter;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A copy of a current certification from each state, territory, or jurisdiction in which the applicant has been certified or otherwise authorized to practice alcohol and drug counseling;</text> </paragraph> <paragraph num="(d)"> <text>Documentation, satisfactory to the Board, that the applicant is currently certified in good standing to practice alcohol and drug counseling in another state, territory, or jurisdiction;</text> </paragraph> <paragraph num="(e)"> <text>Verification that the applicant has:</text> <paragraph num="(i)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a certificate to practice alcohol and drug counseling; and</text> </paragraph> <paragraph num="(ii)"> <text>Not committed any act or omission that would be grounds for discipline or denial of certification under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in the COMAR 10.58.02;</text> </paragraph> <paragraph num="(3)"> <text>Has achieved a passing score on:</text> <paragraph num="(a)"> <text>A national alcohol and drug counselor examination approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Meets all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Complies with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board may waive any examination requirements for an applicant as set forth under Regulation .11B of this chapter.</text> </paragraph> <paragraph num="C."> <text>Educational Requirements. The educational requirements for certification in this State as a certified supervised counselor-alcohol and drug shall be met:</text> <paragraph num="(1)"> <text>As established in Regulation .08 of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>By providing documentation of the substitute educational and experience requirements outlined in §§D and E of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Waiver of Course Requirements. The Board may waive one or more course requirements specified in Regulations .07C and .08C of this chapter, except for documentation from an accredited educational institution showing completion of:</text> <paragraph num="(1)"> <text>12 continuing education units (CEUs) in the ethics of alcohol and drug counseling; or</text> </paragraph> <paragraph num="(2)"> <text>1 semester credit hour or 2 quarter credit hours in the ethics of alcohol and drug counseling.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Equivalent Experience Requirements. The applicant shall provide:</text> <paragraph num="(1)"> <text>Documentation, satisfactory to the Board, of not less than 2 years of supervised clinical experience in alcohol and drug counseling with a minimum of 2,000 hours experience; and</text> </paragraph> <paragraph num="(2)"> <text>Verification, on a Board-approved form, from employers, supervisors, or colleagues that the applicant has practiced alcohol and drug counseling for the length of time stated in §E(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Standards for Supervision."> <paragraph num="A."> <text>Except as otherwise specified in this chapter, this chapter does not apply to personnel or management practices associated with contractual relationships or employment.</text> </paragraph> <paragraph num="B."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Supervise only in those areas within the supervisor’s competence, as determined by:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training; and</text> </paragraph> <paragraph num="(c)"> <text>Experience;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide supervision appropriate to the particular level of licensure or certification being applied for or maintained;</text> </paragraph> <paragraph num="(3)"> <text>Provide supervision in the general content areas established in Health Occupations Article, §§17-302, 17-403, 17-404, and 17-406, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>This subtitle, with special emphasis on the code of ethics chapter, COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §B of this regulation, the supervisor shall specifically instruct and provide guidance relating to:</text> <paragraph num="(1)"> <text>The supervisee’s scope of practice of:</text> <paragraph num="(a)"> <text>Clinical alcohol and drug counseling under Health Occupations Article, §17-101(s), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Alcohol and drug counseling under Health Occupations Article, §17-101(p), Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Activities specified under Regulations .04A, .07A, .08A, and .09A, of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Appropriate billing practices, if applicable to the practice site, including:</text> <paragraph num="(a)"> <text>Financial record keeping and disclosure; and</text> </paragraph> <paragraph num="(b)"> <text>Establishment and disclosure to clients of:</text> <paragraph num="(i)"> <text>Fees for services;</text> </paragraph> <paragraph num="(ii)"> <text>Payment arrangements;</text> </paragraph> <paragraph num="(iii)"> <text>Payment plans;</text> </paragraph> <paragraph num="(iv)"> <text>Financial services; and</text> </paragraph> <paragraph num="(v)"> <text>Terms and conditions of service;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Professional and ethical responsibilities, including a working knowledge of the Board’s code of ethics, as set forth in COMAR 10.58.03;</text> </paragraph> <paragraph num="(5)"> <text>The provision of services involving the application of counseling principles and methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions of individuals or groups, as required by Health Occupations Article, §17-308, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(6)"> <text>Appropriate maintenance and destruction of clinical and financial records.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The following supervisees shall practice alcohol and drug counseling under the supervision of an approved alcohol and drug counselor supervisor as defined under Regulation .02B of this chapter:</text> <paragraph num="(1)"> <text>A licensed graduate alcohol and drug counselor;</text> </paragraph> <paragraph num="(2)"> <text>A certified associate counselor-alcohol and drug;</text> </paragraph> <paragraph num="(3)"> <text>A certified supervised counselor-alcohol and drug; or</text> </paragraph> <paragraph num="(4)"> <text>An alcohol and drug trainee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Supervisor Qualifications."> <paragraph num="A."> <text>An individual providing supervision shall be Board-approved and:</text> <paragraph num="(1)"> <text>Licensed by the Board as a clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(2)"> <text>Licensed by the Board as:</text> <paragraph num="(a)"> <text>A clinical professional counselor;</text> </paragraph> <paragraph num="(b)"> <text>A clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(c)"> <text>A clinical professional art therapist;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A licensed mental health care provider as defined in Regulation .02B of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Certified by the Board as a certified professional counselor-alcohol and drug; or</text> </paragraph> <paragraph num="(5)"> <text>Certified by the Board as a certified associate counselor-alcohol and drug for at least 2 years.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Experience, Education, and Training.</text> <paragraph num="(1)"> <text>A supervisor licensed or certified by the Board, or any Board-approved mental health care provider licensed under Health Occupations Article, Annotated Code of Maryland, with 3 years of documented experience in alcohol and drug counseling, including 3,000 hours of direct client contact, shall complete any of the following options:</text> <paragraph num="(a)"> <text>For a certified professional counselor-alcohol and drug or a certified associate counselor-alcohol and drug, at least 3 semester credit hours or 5 quarter credit hours of undergraduate or graduate-level academic course work that includes counseling supervision;</text> </paragraph> <paragraph num="(b)"> <text>For a licensed clinical alcohol and drug counselor or other board-approved mental health care provider, at least 3 semester credit hours or 5 quarter credit hours of graduate-level academic course work that includes counseling supervision;</text> </paragraph> <paragraph num="(c)"> <text>A Board-approved continuing education program in counseling supervision that includes a minimum of 18 CEUs with a sponsor approved by the Board to provide Category A CEUs as defined under COMAR 10.58.05.05; or</text> </paragraph> <paragraph num="(d)"> <text>Hold the:</text> <paragraph num="(i)"> <text>National Association of Alcohol and Drug Abuse Counselors Approved Clinical Supervisor credential; or</text> </paragraph> <paragraph num="(ii)"> <text>International Certification and Reciprocity Consortium Clinical Supervisor credential.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supervision training required by §B(1) of this regulation may be obtained in a graduate or undergraduate course as provided in §B(1)(a) or (b) of this regulation, or continuing education as listed in §B(1)(c) of this regulation, and may include, but is not limited to, training in:</text> <paragraph num="(a)"> <text>The role and responsibilities of the supervisor;</text> </paragraph> <paragraph num="(b)"> <text>The needs of the supervisee, the supervisor, and the agency setting while:</text> </paragraph> <paragraph num="(c)"> <text>The role of the supervisor as gatekeeper to the profession;</text> </paragraph> <paragraph num="(d)"> <text>Methods for building effective and appropriate relationships with clients;</text> </paragraph> <paragraph num="(e)"> <text>Methods for group supervision; and</text> </paragraph> <paragraph num="(f)"> <text>Models and modalities for practice intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-Supervision Responsibilities of a Supervisor. In addition to meeting the requirements of this regulation, the supervisor shall:</text> <paragraph num="(1)"> <text>File with the Board the approved alcohol and drug supervisor application form;</text> </paragraph> <paragraph num="(2)"> <text>Provide each supervisee with a copy of the Board’s authorization of approved alcohol and drug supervisor status;</text> </paragraph> <paragraph num="(3)"> <text>Have a license or certification that is in good standing; and</text> </paragraph> <paragraph num="(4)"> <text>Be an approved alcohol and drug supervisor as defined under Regulation .02B of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Supervisor Responsibilities."> <text>A supervisor shall:</text> <paragraph num="A."> <text>Agree to and sign a written contract for supervision before initiating supervision;</text> </paragraph> <paragraph num="B."> <text>Ensure that the supervisee is practicing within the scope of the supervisee’s credentialing;</text> </paragraph> <paragraph num="C."> <text>Determine the skill level at which the supervisee may practice;</text> </paragraph> <paragraph num="D."> <text>Focus on primary data from the supervisee’s practice;</text> </paragraph> <paragraph num="E."> <text>Maintain documentation for at least 7 years of supervisory sessions, including:</text> <paragraph num="(1)"> <text>Dates;</text> </paragraph> <paragraph num="(2)"> <text>Duration; and</text> </paragraph> <paragraph num="(3)"> <text>Focus of the supervisory sessions;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>This subtitle, with special emphasis on the code of ethics chapter, COMAR 10.58.03;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Within a reasonable period of time before termination of supervision, provide the supervisee and employer with a written notice of termination to avoid or minimize any harmful effect on the supervisee’s clients or patients;</text> </paragraph> <paragraph num="H."> <text>Be responsible for the professional practices of supervisees;</text> </paragraph> <paragraph num="I."> <text>Provide:</text> <paragraph num="(1)"> <text>For emergency supervision of and direction to a supervisee by a Board-approved alcohol and drug supervisor;</text> </paragraph> <paragraph num="(2)"> <text>A written evaluation of progress to the supervisee on a regular basis or as needed; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the documentation required by §E of this regulation on request by the:</text> <paragraph num="(a)"> <text>Supervisee; or</text> </paragraph> <paragraph num="(b)"> <text>Board or its authorized agent; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Comply with a Board audit of a supervisor’s compliance with regard to the supervisory requirements and responsibilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Supervisee Responsibilities."> <paragraph num="A."> <text>A supervisee shall:</text> <paragraph num="(1)"> <text>Verify that the supervisor has been approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Agree to and sign a Board-approved contract before initiating supervision;</text> </paragraph> <paragraph num="(3)"> <text>Attend and participate in supervision as agreed to in the supervision contract;</text> </paragraph> <paragraph num="(4)"> <text>Prepare for supervision using case materials related to the supervisee’s alcohol and drug counseling practice;</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of supervisory sessions for at least 7 years, to be available for verification to the Board or its authorized agent, including:</text> <paragraph num="(a)"> <text>Dates;</text> </paragraph> <paragraph num="(b)"> <text>Duration; and</text> </paragraph> <paragraph num="(c)"> <text>Focus of the supervision; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Follow all terms of the written contract for supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisee may not engage in the practice of alcohol and drug counseling independently.</text> </paragraph> <paragraph num="C."> <text>A supervisee shall provide each client with a copy of the supervisee’s professional disclosure statement, as required by Health Occupations Article, §17-507, Annotated Code of Maryland, stating:</text> <paragraph num="(1)"> <text>That the supervisee’s alcohol and drug counseling services are provided under supervision; and</text> </paragraph> <paragraph num="(2)"> <text>The name of the supervisor, including the supervisor’s address and contact information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisee shall obtain from each client a signed informed consent for treatment form which indicates that the client:</text> <paragraph num="(1)"> <text>Is aware that counseling services are being provided under supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Consents to the recording of counseling sessions, and the sharing of client information, acknowledging that all of these materials may be shared with:</text> <paragraph num="(a)"> <text>The approved alcohol and drug supervisor of record; or</text> </paragraph> <paragraph num="(b)"> <text>The instructor supervising an education-related practicum.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-101, 17-102, 17-205, 17-301, 17-302, 17-305, 17-308, 17-309, 17-401(b), 17-403—17-407, and 17-501—17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); adopted permanently effective January 21, 2002 (29:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); amended permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 23, 2006 (33:23 Md. R. 1796)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07 and .08 adopted as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); amended as an emergency provision effective March 30, 2002 (29:7 Md. R. 617); adopted permanently effective June 24, 2002 (29:12 Md. R. 929)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective August 15, 2002 (29:18 Md. R. 1439); amended permanently effective November 25, 2002 (29:23 Md. R. 1811)</annotation> <annotation type="History" subtype="Administrative History">Regulations .09—.12 adopted as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); adopted permanently effective January 21, 2002 (29:1 Md. R. 23)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective November 23, 2006 (33:23 Md. R. 1796)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); adopted permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 22, 2013 (40:14 Md. R. 1176)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, D amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 31, 2018 (45:26 Md. R. 1247)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective June 28, 2021 (48:13 Md. R. 508)</annotation> </annotations> </chapter> <chapter num="08" heading="Marriage and Family Therapists — Requirements for Licensure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Establishes the requirements for an individual to practice clinical marriage and family therapy;</text> </paragraph> <paragraph num="B."> <text>Establishes standards of supervision and the responsibilities of supervisors and supervisees in the practice of clinical marriage and family therapy;</text> </paragraph> <paragraph num="C."> <text>Applies to licensees who:</text> <paragraph num="(1)"> <text>Practice clinical marriage and family therapy; or</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision for licensed graduate marriage and family therapists; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Applies to licensed graduate marriage and family therapists who are in the process of obtaining the supervised clinical experience required by Health Occupations Article, §17-303, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means a Board-approved college or university that is accredited by a national or regional accrediting body recognized by the Council on Post-Secondary Accreditation or through one of the following bodies recognized by the U.S. Department of Education:</text> <paragraph num="(a)"> <text>The Middle States Association of Colleges and Schools — the Commission on Higher Education;</text> </paragraph> <paragraph num="(b)"> <text>The New England Association of Schools and Colleges;</text> </paragraph> <paragraph num="(c)"> <text>The North Central Association of Schools and Colleges;</text> </paragraph> <paragraph num="(d)"> <text>The Northwest Association of Schools and of Colleges and Universities;</text> </paragraph> <paragraph num="(e)"> <text>The Southern Association of Colleges and Schools; and</text> </paragraph> <paragraph num="(f)"> <text>The Western Association of Colleges and Schools.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Appraisal” means:</text> <paragraph num="(a)"> <text>Selecting, administering, scoring, and interpreting instruments designed to assess an individual's aptitudes, attitudes, abilities, achievements, interests, and personal characteristics; and</text> </paragraph> <paragraph num="(b)"> <text>Using nonstandardized methods and techniques for understanding human behavior in relation to coping with, adapting to, or changing life situations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Board-approved marriage and family therapy supervisor” means:</text> <paragraph num="(a)"> <text>An American Association for Marriage and Family Therapy approved and Board-approved:</text> <paragraph num="(i)"> <text>Supervisor;</text> </paragraph> <paragraph num="(ii)"> <text>Supervisor in training; or</text> </paragraph> <paragraph num="(iii)"> <text>Supervisor candidate;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A licensed clinical marriage and family therapist who:</text> <paragraph num="(i)"> <text>Meets the requirements for licensure under this chapter; and</text> </paragraph> <paragraph num="(ii)"> <text>Has been approved by the Board;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A licensed clinical professional counselor, licensed clinical marriage and family therapist, licensed clinical professional art therapist, or licensed clinical alcohol and drug counselor who meets the requirements for licensure under Health Occupations Article, Title 17, Annotated Code of Maryland, and has been approved by the Board; or</text> </paragraph> <paragraph num="(d)"> <text>An individual who is authorized by law to practice a health occupation which includes the diagnosis, prevention, treatment, and amelioration of psychological problems and emotional or mental conditions of individuals or groups, and has been approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Client contact hour” means at least 45 minutes of direct session time with a client present.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical supervision hour” means at least 45 minutes of direct supervision time with the supervisee present.</text> </paragraph> <paragraph num="(6)"> <text>“Direct clinical marriage and family therapy services” means the provision of face-to-face clinical marriage and family therapy services to clients and their significant others that includes, but is not limited, to the following:</text> <paragraph num="(a)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Family counseling;</text> </paragraph> <paragraph num="(d)"> <text>Couples counseling;</text> </paragraph> <paragraph num="(e)"> <text>Evaluation;</text> </paragraph> <paragraph num="(f)"> <text>Intake or assessment;</text> </paragraph> <paragraph num="(g)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(h)"> <text>Treatment planning with a client; and</text> </paragraph> <paragraph num="(i)"> <text>Crisis management or intervention.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Face-to-Face.</text> <paragraph num="(a)"> <text>“Face-to-face” means in the physical presence of an individual or using video conferencing which allows individuals to hear and see each other in synchronous points of time.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face” does not include:</text> <paragraph num="(i)"> <text>Telephone communication; or</text> </paragraph> <paragraph num="(ii)"> <text>Internet communication that does not involve synchronous video conferencing, such as instant messaging services and social networking sites.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Indirect clinical marriage and family therapy services” means all case management and professional development activities related to the provision of clinical marriage and family therapy services to a client that include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>Referral;</text> </paragraph> <paragraph num="(b)"> <text>Intake or assessment by telephone or other means when the client is not face-to-face;</text> </paragraph> <paragraph num="(c)"> <text>Receiving individual and group supervision at site or at the university;</text> </paragraph> <paragraph num="(d)"> <text>Consultation with other professionals;</text> </paragraph> <paragraph num="(e)"> <text>Treatment planning with other professionals;</text> </paragraph> <paragraph num="(f)"> <text>Case staffing;</text> </paragraph> <paragraph num="(g)"> <text>Staff meetings;</text> </paragraph> <paragraph num="(h)"> <text>Related trainings and seminars;</text> </paragraph> <paragraph num="(i)"> <text>Record keeping;</text> </paragraph> <paragraph num="(j)"> <text>Report writing;</text> </paragraph> <paragraph num="(k)"> <text>Case notes;</text> </paragraph> <paragraph num="(l)"> <text>Providing clinical training;</text> </paragraph> <paragraph num="(m)"> <text>Telephone triage;</text> </paragraph> <paragraph num="(n)"> <text>Case management;</text> </paragraph> <paragraph num="(o)"> <text>Program development; and</text> </paragraph> <paragraph num="(p)"> <text>Other clinical marriage and family therapy administrative duties as required by the setting in which the clinical hours are accrued.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Licensed clinical marriage and family therapist” means an individual approved by the Board to practice clinical marriage and family therapy.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed graduate marriage and family therapist” means an individual approved by the Board to practice graduate marriage and family therapy under the supervision of a Board-approved marriage and family therapy supervisor while fulfilling the supervised clinical experience for licensure under Health Occupations Article, §§17-303 and 17-309, Annotated Code of Maryland, and Regulation .04B of this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Licensed mental health care provider” means a:</text> <paragraph num="(a)"> <text>Licensed clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed clinical professional counselor, licensed clinical alcohol and drug counselor, licensed clinical professional art therapist, licensed certified social worker-clinical, psychiatrist, psychologist, or psychiatric nurse practitioner who is authorized by law to practice a health occupation that includes the diagnosis, prevention, treatment, and amelioration of psychological problems and emotional or mental conditions of individuals or groups.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Marriage and family therapy field” means a specific degree program with a marriage and family therapy emphasis, including, but not limited to, the following areas:</text> <paragraph num="(a)"> <text>Marriage and family therapy, including:</text> <paragraph num="(i)"> <text>Marriage and family counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Couple and family therapy;</text> </paragraph> <paragraph num="(iii)"> <text>Couple and family counseling;</text> </paragraph> <paragraph num="(iv)"> <text>Family and systems therapy;</text> </paragraph> <paragraph num="(v)"> <text>Family therapy; or</text> </paragraph> <paragraph num="(vi)"> <text>Family counseling;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Counseling practice under Health Occupations Article, Title 17, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Practice areas of other mental health providers, including:</text> <paragraph num="(i)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(ii)"> <text>Psychology;</text> </paragraph> <paragraph num="(iii)"> <text>Social Work;</text> </paragraph> <paragraph num="(iv)"> <text>Psychiatric nursing; or</text> </paragraph> <paragraph num="(v)"> <text>Any other program of study approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Practice clinical marriage and family therapy” means:</text> <paragraph num="(a)"> <text>To engage professionally and for compensation in marriage and family therapy and appraisal activities by providing services involving the application of therapy principles and methods in the diagnosis, crisis management, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions of individuals or groups, including couples and families; and</text> </paragraph> <paragraph num="(b)"> <text>The use of instruments that require specialized psychological training for administration and interpretation as described in Health Occupations Article, §17-310, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Practice graduate marriage and family therapy” means to practice marriage and family therapy:</text> <paragraph num="(a)"> <text>Under the supervision of a Board-approved marriage and family therapy supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>While fulfilling the requirements for supervised experience under:</text> <paragraph num="(i)"> <text>Health Occupations Article, §17-303, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulation .04 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Psychotherapy” means providing clinical services that involve:</text> <paragraph num="(a)"> <text>The professional application of psychotherapy and counseling theories and methods, including, but not limited to, psychodynamic, cognitive, behavioral, humanistic, systems theories, or trauma informed care to assist the client in:</text> <paragraph num="(i)"> <text>Improving functioning;</text> </paragraph> <paragraph num="(ii)"> <text>Obtaining symptom relief;</text> </paragraph> <paragraph num="(iii)"> <text>Preventing psychosocial dysfunction;</text> </paragraph> <paragraph num="(iv)"> <text>Changing personality; or</text> </paragraph> <paragraph num="(v)"> <text>Maintaining improved functioning; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Situations in which the principal discourse involves, but is not limited to:</text> <paragraph num="(i)"> <text>Diagnosis of psychopathology based on standard diagnostic criteria;</text> </paragraph> <paragraph num="(ii)"> <text>Psychotherapeutic treatment of mental disorders, emotional disorders, and adjustment reactions utilizing clinically appropriate treatment modalities;</text> </paragraph> <paragraph num="(iii)"> <text>Childhood trauma and abuse;</text> </paragraph> <paragraph num="(iv)"> <text>Identifying and changing self-defeating patterns of behaving, thinking, feeling, believing, or interacting with others in systems;</text> </paragraph> <paragraph num="(v)"> <text>Developmental issues;</text> </paragraph> <paragraph num="(vi)"> <text>Personality development; or</text> </paragraph> <paragraph num="(vii)"> <text>Problems related to disorders of thinking, emotional suffering, addictions, behavior, or interpersonal dysfunctions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Related field” means a profession using counseling whose academic requirements include degree programs from an accredited college or university that has curricula in areas such as expressive therapy, gerontology, human services, marriage and family therapy, mental health, pastoral counseling, psychology, psychotherapy, social work, and other areas approved by the Board.</text> </paragraph> <paragraph num="(17)"> <text>“Relative” means an individual connected to another by:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Marriage;</text> </paragraph> <paragraph num="(c)"> <text>Guardianship; or</text> </paragraph> <paragraph num="(d)"> <text>Domestic partnership.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Scope of competence” means that area within which the individual is proficient to practice, based on education, training, supervised experience, and professional credentials.</text> </paragraph> <paragraph num="(19)"> <text>“Substantially equivalent” means:</text> <paragraph num="(a)"> <text>A degree in a program of studies determined by the Board to have:</text> <paragraph num="(i)"> <text>Substantial marriage and family therapy emphasis in the subject matter; and</text> </paragraph> <paragraph num="(ii)"> <text>The extent of training required for the specified level of licensure; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The applicant meets the relevant qualifications stated in Health Occupations Article, §17–303, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Supervised clinical experience in marriage and family therapy” means the provision of marriage and family therapy services conducted under the supervision of a Board-approved marriage and family therapy supervisor.</text> </paragraph> <paragraph num="(21)"> <text>“Supervisee” means a licensed graduate marriage and family therapist obtaining the supervised experience required by Health Occupations Article, §17-303, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee in which the supervisor directs, guides, monitors, instructs, and evaluates the supervisee’s clinical marriage and family therapy practice while promoting development of the supervisee’s knowledge, skills, and abilities to provide clinical marriage and family therapy services in an ethical and competent manner and includes an acceptance of direct responsibility for the client services rendered by the supervisee.</text> </paragraph> <paragraph num="(23)"> <text>Supervision Training.</text> <paragraph num="(a)"> <text>“Supervision training” means a course or program designed to provide information regarding the supervision process utilized by licensed clinical marriage and family therapists in a variety of settings.</text> </paragraph> <paragraph num="(b)"> <text>“Supervision training” includes training obtained through:</text> <paragraph num="(i)"> <text>Graduate-level course work;</text> </paragraph> <paragraph num="(ii)"> <text>Continuing education units (CEUs); or</text> </paragraph> <paragraph num="(iii)"> <text>Other training hours approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Under the supervision of a Board-approved marriage and family therapy supervisor” means engaging in an ongoing process of receiving direction from a Board-approved supervisor that includes:</text> <paragraph num="(a)"> <text>Monitoring the performance of a supervisee; and</text> </paragraph> <paragraph num="(b)"> <text>Providing documented and direct consultation, guidance, and instruction with respect to clinical skill and competency.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Written contract for supervision” means an agreement between the supervisee and Board-approved supervisor that is initiated before beginning supervision and that details the scope of supervision and includes at a minimum the following:</text> <paragraph num="(a)"> <text>Name and credentials of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(b)"> <text>Primary purpose, goals, and objectives of the supervision process;</text> </paragraph> <paragraph num="(c)"> <text>Details of provisions, including frequency, format, and case or chart review;</text> </paragraph> <paragraph num="(d)"> <text>Methods of documentation;</text> </paragraph> <paragraph num="(e)"> <text>Duties and responsibilities of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(f)"> <text>Procedural considerations in the case of the supervisor’s absence; and</text> </paragraph> <paragraph num="(g)"> <text>Information regarding the supervisor’s scope of competence.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Process for Licensure."> <paragraph num="A."> <text>In order to obtain a license, an applicant shall:</text> <paragraph num="(1)"> <text>Complete and return the Board-approved application;</text> </paragraph> <paragraph num="(2)"> <text>Submit an official transcript from an accredited educational institution awarding the highest degree attained in clinical marriage and family therapy or a related field;</text> </paragraph> <paragraph num="(3)"> <text>Pay all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(4)"> <text>Submit to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(6)"> <text>Be at least 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applications shall be acted upon as follows:</text> <paragraph num="(1)"> <text>Within 30 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice, the applicant shall correct the deficiency within 90 days, or other period specified in the notice;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the Board determines that an applicant is eligible to take the required examinations, the Board shall send a notice of approval to the applicant;</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of the approval notice, the applicant shall have 1 year from the date of the notice to take the examinations; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant fails to take the examinations within 1 year from the date of the approval notice, the requirements set forth under §B(4) of this regulation shall apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensed Graduate Marriage and Family Therapists."> <paragraph num="A."> <text>To qualify for licensure as a graduate marriage and family therapist, an applicant shall have:</text> <paragraph num="(1)"> <text>One of the following from an accredited educational institution approved by the Board:</text> <paragraph num="(a)"> <text>For an applicant holding a master’s degree in marriage and family therapy, or a substantially equivalent program, completed a minimum of 60 semester credit hours or 90 graduate quarter credit hours; or</text> </paragraph> <paragraph num="(b)"> <text>For an applicant holding a doctoral degree in marriage and family therapy, or a substantially equivalent program, completed a minimum of 90 graduate semester credit hours or 135 graduate quarter credit hours;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 45 graduate semester credit hours or 68 graduate quarter credit hours as required by Regulation .05B of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Of the graduate credit hours required by §A(1) and (2) of this regulation, completed a minimum of 45 credit hours in each of the following areas:</text> <paragraph num="(a)"> <text>A supervised clinical internship or practicum that includes at least 60 hours completed under the supervision of a Board-approved supervisor and 300 hours of direct client contact with couples, families, and individuals, at least 100 hours of which are relational therapy;</text> </paragraph> <paragraph num="(b)"> <text>Normal and abnormal personality development which includes individual development across the life span and the family life cycle;</text> </paragraph> <paragraph num="(c)"> <text>Psychopathology with emphasis on standard diagnostic manuals, as well as family systems models;</text> </paragraph> <paragraph num="(d)"> <text>Diagnosis and treatment of mental and emotional disorders in family systems;</text> </paragraph> <paragraph num="(e)"> <text>A comprehensive survey of the extant major models of family therapy;</text> </paragraph> <paragraph num="(f)"> <text>At least two courses which focus on a minimum of three marriage and family therapy models;</text> </paragraph> <paragraph num="(g)"> <text>A comprehensive survey of the extant, major models of couples therapy;</text> </paragraph> <paragraph num="(h)"> <text>An intensive study of at least three different models of couples therapy:</text> </paragraph> <paragraph num="(i)"> <text>One course covering gender and ethnicity as they relate to marriage and family theory and practice, or two separate courses with one focusing on gender issues and the other one on ethnicity as they relate to marriage and family therapy;</text> </paragraph> <paragraph num="(j)"> <text>Sexual issues in marriage and family therapy, including:</text> <paragraph num="(i)"> <text>Sexual normality;</text> </paragraph> <paragraph num="(ii)"> <text>Sexual dysfunction;</text> </paragraph> <paragraph num="(iii)"> <text>Sexual orientation; and</text> </paragraph> <paragraph num="(iv)"> <text>Sexual identity; and</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>Ethical, legal, and professional issues in marriage and family therapy;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="D."> <text>A licensed graduate marriage and family therapist shall practice clinical marriage and family therapy under the supervision of a Board-approved marriage and family therapy supervisor.</text> </paragraph> <paragraph num="E."> <text>A licensed graduate marriage and family therapist may not:</text> <paragraph num="(1)"> <text>Practice independent of supervision; or</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Expiration and Extension.</text> <paragraph num="(1)"> <text>The graduate marriage and family therapist license expires 2 years after the date issued.</text> </paragraph> <paragraph num="(2)"> <text>If a licensed graduate marriage and family therapist is unable to accumulate the required clinical hours for licensure as a clinical marriage and family therapist within 2 years, the licensed graduate marriage and family therapist may apply on a Board-approved form for a 2-year extension before the current license expires, up to a maximum of 6 years, except as provided in §F(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>For a licensed graduate marriage and family therapist who has been granted a 2-year extension, CEUs are not required for the first 2-year extension. Subsequent extensions approved by the Board shall be subject to the continuing education requirements in COMAR 10.58.05.</text> </paragraph> <paragraph num="(4)"> <text>If a licensed graduate marriage and family therapist notifies the Board in writing, the Board may grant, in certain circumstances, a license extension beyond the 6-year maximum as set forth in §F(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the license renewal date, the Board may reinstate the license of a licensed graduate marriage and family therapist otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes within that 5-year period the minimum of 20 CEUs required for each year; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the reinstatement fee set by the Board in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and .06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed graduate marriage and family therapist whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice graduate marriage and family therapy.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensed Clinical Marriage and Family Therapists."> <paragraph num="A."> <text>To qualify for licensure as a clinical marriage and family therapist, an applicant shall have:</text> <paragraph num="(1)"> <text>A graduate marriage and family therapist license or other credential approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Completed the course work requirements set forth under Regulation .04B of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Completed a minimum of 2 years and 2,000 hours of clinical experience in marriage and family therapy, of which:</text> <paragraph num="(a)"> <text>A minimum of the 1,000 hours shall be direct clinical therapy services;</text> </paragraph> <paragraph num="(b)"> <text>A maximum of 1,000 hours may consist of indirect clinical therapy services;</text> </paragraph> <paragraph num="(c)"> <text>A minimum of 2,000 hours of supervised clinical experience as a licensed graduate marriage and family therapist shall be completed after the awarding of the master's degree under a Board-approved supervisor;</text> </paragraph> <paragraph num="(d)"> <text>At least 80 percent of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under the supervision of a Board-approved marriage and family therapy supervisor who is a licensed clinical marriage and family therapist; and</text> </paragraph> <paragraph num="(e)"> <text>No more than 20 percent of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under the supervision of a Board-approved marriage and family therapy supervisor, as defined in Regulation .02B of this chapter, who is one of the following, provided the supervisor can document a minimum of 5 years’ experience delivering marriage and family therapy services:</text> <paragraph num="(i)"> <text>A licensed clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(ii)"> <text>A licensed clinical professional counselor;</text> </paragraph> <paragraph num="(iii)"> <text>A licensed clinical professional art therapist: or</text> </paragraph> <paragraph num="(iv)"> <text>Another licensed mental health care provider as defined under Regulation .02B of this chapter and approved by the Board; and</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>100 hours of face-to-face clinical supervision hours shall be completed within 2 years of the awarding of the master’s degree, including:</text> <paragraph num="(i)"> <text>A minimum of 50 hours shall be individual face-to-face clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>A maximum of 50 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board may include hours of clinical supervised experience obtained in another jurisdiction toward the total 2,000 required hours of supervised experience required for the licensed clinical marriage and family therapist, if the clinical experience hours:</text> <paragraph num="(1)"> <text>Were obtained in accordance with the rules and regulations of that jurisdiction; and</text> </paragraph> <paragraph num="(2)"> <text>Included the course work requirements set forth under Regulation .06D of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew a clinical marriage and family therapist license, the applicant shall:</text> <paragraph num="(a)"> <text>Submit a completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required application fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed clinical marriage and family therapist shall comply with the renewal requirements as provided in Health Occupations Article, §17–504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to renew licensure:</text> <paragraph num="(a)"> <text>Is not authorized to and may not practice clinical marriage and family therapy; and</text> </paragraph> <paragraph num="(b)"> <text>May be subject to sanctions pursuant to Health Occupations Article, §§17-513 and 17-604, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the license renewal date, the Board may reinstate the license of a licensed clinical marriage and family therapist otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes within that 5-year period the minimum of 20 CEUs required for each year; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the reinstatement fee set by the Board in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and.06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed clinical marriage and family therapist whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice clinical marriage and family therapy.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §17-505, Annotated Code of Maryland, a request to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(a)"> <text>Completed Board-approved application; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of the required, nonrefundable, annual fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual may apply for inactive status only if the individual’s license is still active at the time application for inactive status is made.</text> </paragraph> <paragraph num="(3)"> <text>An individual on inactive status is not authorized to and may not practice clinical marriage and family therapy.</text> </paragraph> <paragraph num="(4)"> <text>Within 5 calendar years after being placed on inactive status, an individual seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed 20 CEUs for each year of inactive status, at least 40 of which shall have been obtained within the 2-year period immediately preceding the application for reinstatement.</text> </paragraph> <paragraph num="(5)"> <text>If an individual on inactive status seeks to be reinstated beyond the required 5-year period and conditions set forth under §G(4) of this regulation, the individual shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Licensure Eligibility: Out-of-State Applicants."> <paragraph num="A."> <text>An applicant licensed as a clinical marriage and family therapist or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for licensure if the applicant:</text> <paragraph num="(1)"> <text>Provides:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>A copy of a current license from each state, territory, or jurisdiction in which the applicant has been licensed, registered, or otherwise authorized to practice clinical marriage and family therapy;</text> </paragraph> <paragraph num="(c)"> <text>Documentation, satisfactory to the Board, that the applicant is currently licensed in good standing to practice clinical marriage and family therapy in another state, territory, or jurisdiction; and</text> </paragraph> <paragraph num="(d)"> <text>Verification that the applicant has:</text> <paragraph num="(i)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a license to practice clinical marriage and family therapy; and</text> </paragraph> <paragraph num="(ii)"> <text>Not committed any act or omission that would be grounds for discipline or denial of licensure under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(3)"> <text>Has achieved a passing score on an examination of:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>This subtitle;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submits to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Is of good moral character; and</text> </paragraph> <paragraph num="(6)"> <text>Complies with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board shall waive the requirements for an applicant:</text> <paragraph num="(1)"> <text>To pass a national certification examination; and</text> </paragraph> <paragraph num="(2)"> <text>Who meets the qualifications otherwise required by Health Occupations Article, Title 17, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standards for Supervision."> <paragraph num="A."> <text>Except as otherwise specified in this chapter, this chapter does not apply to personnel or management practices associated with contractual relationships or employment.</text> </paragraph> <paragraph num="B."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Supervise only in those areas within the supervisor’s competence, as determined by:</text> <paragraph num="(a)"> <text>Education;</text> </paragraph> <paragraph num="(b)"> <text>Training; and</text> </paragraph> <paragraph num="(c)"> <text>Experience;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide supervision appropriate to the particular level of licensure being applied for or maintained;</text> </paragraph> <paragraph num="(3)"> <text>Provide supervision in the general content areas established in Health Occupations Article, §17-303, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland: and</text> </paragraph> <paragraph num="(b)"> <text>This subtitle, with special emphasis on the code of ethics under COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §B of this regulation, the supervisor shall specifically instruct and provide guidance relating to the supervisee’s scope of practice of clinical marriage and family therapy under Health Occupations Article, §17-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>The supervisor shall also instruct and provide guidance to supervisees in:</text> <paragraph num="(1)"> <text>Appropriate billing practices if applicable to the practice site, including:</text> <paragraph num="(a)"> <text>Financial record keeping and disclosure; and</text> </paragraph> <paragraph num="(b)"> <text>Establishment and disclosure to clients of:</text> <paragraph num="(i)"> <text>Fees for services;</text> </paragraph> <paragraph num="(ii)"> <text>Payment arrangements;</text> </paragraph> <paragraph num="(iii)"> <text>Payment plans;</text> </paragraph> <paragraph num="(iv)"> <text>Financial services; and</text> </paragraph> <paragraph num="(v)"> <text>Terms and conditions of service;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Providing services involving the application of therapy principles and methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions of individuals, families, couples, or groups, as stated in Health Occupations Article, §17-308, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Appropriate maintenance and destruction of clinical and financial records.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The following individuals may not provide clinical supervision for a licensed graduate marriage and family therapy supervisee:</text> <paragraph num="(1)"> <text>A relative;</text> </paragraph> <paragraph num="(2)"> <text>A licensed graduate marriage and family therapist, licensed graduate alcohol and drug counselor, a certified alcohol and drug counselor, licensed graduate professional counselor, licensed graduate professional art therapist, or any other graduate-level health care provider licensed under Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(3)"> <text>An individual with whom there could be a conflict of interest, including, but not limited to, an employee supervising their own employer or a student supervising their own teacher.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Supervisor Qualifications."> <paragraph num="A."> <text>Licensure. An individual providing supervision shall be:</text> <paragraph num="(1)"> <text>Licensed by the Board as a clinical:</text> <paragraph num="(a)"> <text>Marriage and family therapist;</text> </paragraph> <paragraph num="(b)"> <text>Professional counselor;</text> </paragraph> <paragraph num="(c)"> <text>Alcohol and drug counselor; or</text> </paragraph> <paragraph num="(d)"> <text>Professional art therapist; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed mental health care provider as defined in Regulation .02B of this chapter and approved by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Education, Training, or Supervision Experience.</text> <paragraph num="(1)"> <text>A Board-approved supervisor, or any licensed mental health care provider as defined in Regulation .02B of this chapter who is approved by the Board and has completed 3 years of documented experience in clinical marriage and family therapy shall complete at least one of the following education and training experiences:</text> <paragraph num="(a)"> <text>2 years of documented experience providing clinical supervision for marriage and family therapists working with families from a systemic perspective and conceptualizing family cases using a recognized family theoretical model;</text> </paragraph> <paragraph num="(b)"> <text>At least 3 graduate semester credit hours or 5 quarter credit hours of academic course work in clinical supervision;</text> </paragraph> <paragraph num="(c)"> <text>A graduate-level course in marriage and family therapy supervision;</text> </paragraph> <paragraph num="(d)"> <text>The American Association for Marriage and Family Therapy Approved Supervisor designation; or</text> </paragraph> <paragraph num="(e)"> <text>The American Association for Marriage and Family Therapy Supervisor in Training or Supervisor Candidate designation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition to the requirements of §B(1) of this regulation, a supervisor shall complete at least 6 semester credit hours or 10 quarter credit hours of graduate-level academic training in Theories of Couples and Family Therapy.</text> </paragraph> <paragraph num="(3)"> <text>Supervision training required by this section may be obtained in a graduate course as listed in §B(1) of this regulation and may include, but not be limited to:</text> <paragraph num="(a)"> <text>The role and responsibilities of the supervisor;</text> </paragraph> <paragraph num="(b)"> <text>The needs of the supervisee, supervisor, and the agency setting while maintaining a clear ethical perspective, including:</text> <paragraph num="(i)"> <text>The maintenance of appropriate boundaries; and</text> </paragraph> <paragraph num="(ii)"> <text>Making clinically appropriate diagnoses;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The role of the supervisor as gatekeeper to the profession;</text> </paragraph> <paragraph num="(d)"> <text>Methods for building effective and appropriate relationships with clients;</text> </paragraph> <paragraph num="(e)"> <text>Models for group supervision; and</text> </paragraph> <paragraph num="(f)"> <text>Models and modalities for practice intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-Supervision Responsibilities of a Supervisor. In addition to meeting the requirements of this regulation, before beginning supervision, the Board-approved supervisor shall:</text> <paragraph num="(1)"> <text>File the completed Board-approved supervisor application form;</text> </paragraph> <paragraph num="(2)"> <text>Provide the supervisee with a copy of the Board’s licensed clinical marriage and family therapy approved supervisor letter; and</text> </paragraph> <paragraph num="(3)"> <text>Have an active license that is without restrictions or conditions due to disciplinary action for the 2 years preceding an application for licensed clinical marriage and family therapy Board-approved supervisor status.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisor may be an:</text> <paragraph num="(1)"> <text>Agency-designated supervisor; or</text> </paragraph> <paragraph num="(2)"> <text>Independent supervisor in private practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supervisor Responsibilities."> <text>A supervisor shall:</text> <paragraph num="A."> <text>Agree to and sign a written contract for supervision before initiating supervision;</text> </paragraph> <paragraph num="B."> <text>Ensure that the supervisee is practicing within the scope of the supervisee’s license;</text> </paragraph> <paragraph num="C."> <text>Determine the skill level at which the supervisee may practice;</text> </paragraph> <paragraph num="D."> <text>Focus on primary data from the supervisee’s practice;</text> </paragraph> <paragraph num="E."> <text>Maintain documentation, for at least 7 years, of supervisory sessions, including:</text> <paragraph num="(1)"> <text>Dates;</text> </paragraph> <paragraph num="(2)"> <text>Duration; and</text> </paragraph> <paragraph num="(3)"> <text>Focus of the supervisory sessions;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>This subtitle with special emphasis on the code of ethics under COMAR 10.58.03;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Within a reasonable period of time before termination of supervision, provide the supervisee and employer with a written notice of termination to avoid or minimize any harmful effect on the supervisee’s clients or patients;</text> </paragraph> <paragraph num="H."> <text>Be responsible for the clinical marriage and family therapy practices of supervisees;</text> </paragraph> <paragraph num="I."> <text>Provide:</text> <paragraph num="(1)"> <text>For emergency supervision and direction to a supervisee by a Board-approved supervisor;</text> </paragraph> <paragraph num="(2)"> <text>A written evaluation of progress to the supervisee on a regular basis or as needed; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the documentation required by §E of this regulation on request by the:</text> <paragraph num="(a)"> <text>Supervisee; or</text> </paragraph> <paragraph num="(b)"> <text>Board or its authorized agent; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Comply with a Board audit of a Board-approved supervisor’s compliance with regard to the supervisory requirements and responsibilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Supervisee Responsibilities."> <paragraph num="A."> <text>A supervisee shall:</text> <paragraph num="(1)"> <text>Verify that the supervisee's supervisor has been approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Agree to and sign a written contract for supervision before initiating supervision;</text> </paragraph> <paragraph num="(3)"> <text>Attend and participate in supervision as agreed to in the supervision contract;</text> </paragraph> <paragraph num="(4)"> <text>Prepare for supervision using case materials related to the supervisee’s clinical marriage and family therapy practice;</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of supervisory sessions for at least 7 years, to be available for verification to the Board or its authorized agent, including:</text> <paragraph num="(a)"> <text>Dates;</text> </paragraph> <paragraph num="(b)"> <text>Duration; and</text> </paragraph> <paragraph num="(c)"> <text>Focus of the supervision; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Follow all terms of the written contract for supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisee may not engage in the practice of clinical marriage and family therapy independent of supervision.</text> </paragraph> <paragraph num="C."> <text>A supervisee shall provide the client with a copy of a professional disclosure statement as required under Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states the marriage and family therapy services are provided under clinical supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name of the supervisor with address and contact information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisee shall obtain a signed informed consent for treatment form from the client which indicates that the client:</text> <paragraph num="(1)"> <text>Is aware that marriage and family therapy services are being provided under clinical supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Consents to the recording of therapy sessions and the sharing of client information and, acknowledges that all these materials may be shared with:</text> <paragraph num="(a)"> <text>The Board-approved supervisor of record; or</text> </paragraph> <paragraph num="(b)"> <text>The instructor supervising an education-related practicum.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-101, 17-205, 17-301, 17-303, 17-306, 17-308, 17-309, 17-507, and 17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); adopted permanently effective January 21, 2002 (29:1 Md. R. 24)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); amended permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); adopted permanently effective March 3, 2003 (30:4 Md. R. 317)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective June 6, 2005 (32:11 Md. R. 983)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective May 17, 2010 (37:10 Md. R. 723)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 28, 2014 (41:8 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective April 4, 2022 (49:7 Md. R. 467)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective November 24, 2025 (52:23 Md. R. 1140)</annotation> </annotations> </chapter> <chapter num="09" heading="Disciplinary Sanctions and Monetary Penalties"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of disciplinary sanctions and monetary penalties for violations of the Maryland Professional Counselors and Therapists Act, Health Occupations Article, §17-509, Annotated Code of Maryland by any:</text> <paragraph num="A."> <text>Licensed clinical professional counselor;</text> </paragraph> <paragraph num="B."> <text>Licensed graduate professional counselor;</text> </paragraph> <paragraph num="C."> <text>Licensed clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="D."> <text>Licensed graduate alcohol and drug counselor;</text> </paragraph> <paragraph num="E."> <text>Licensed clinical marriage and family therapist;</text> </paragraph> <paragraph num="F."> <text>Licensed graduate marriage and family therapist;</text> </paragraph> <paragraph num="G."> <text>Licensed clinical art therapist;</text> </paragraph> <paragraph num="H."> <text>Licensed graduate art therapist;</text> </paragraph> <paragraph num="I."> <text>Certified professional counselor;</text> </paragraph> <paragraph num="J."> <text>Certified professional counselor-alcohol and drug;</text> </paragraph> <paragraph num="K."> <text>Certified professional counselor-marriage and family therapist;</text> </paragraph> <paragraph num="L."> <text>Certified associate counselor-alcohol and drug; or</text> </paragraph> <paragraph num="M."> <text>Certified supervised counselor-alcohol and drug.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Act” means the Maryland Professional Counselors and Therapists Act.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the State Board of Professional Counselors and Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“License” means one of eight types of licenses issued by the Board to practice as follows:</text> <paragraph num="(a)"> <text>Clinical professional counseling (LCPC);</text> </paragraph> <paragraph num="(b)"> <text>Clinical marriage and family therapy (LCMFT);</text> </paragraph> <paragraph num="(c)"> <text>Clinical alcohol and drug counseling (LCADC);</text> </paragraph> <paragraph num="(d)"> <text>Clinical professional art therapy (LCPAT);</text> </paragraph> <paragraph num="(e)"> <text>Graduate professional counseling (LGPC);</text> </paragraph> <paragraph num="(f)"> <text>Graduate marriage and family therapy (LGMFT);</text> </paragraph> <paragraph num="(g)"> <text>Graduate alcohol and drug counseling (LGADC); or</text> </paragraph> <paragraph num="(h)"> <text>Graduate professional art therapy (LGPAT).</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Licensee” means:</text> <paragraph num="(a)"> <text>A clinical or graduate professional counselor;</text> </paragraph> <paragraph num="(b)"> <text>A clinical or graduate marriage and family therapist;</text> </paragraph> <paragraph num="(c)"> <text>A clinical or graduate alcohol and drug counselor; or</text> </paragraph> <paragraph num="(d)"> <text>A clinical or graduate professional art therapist who is licensed by the Board to practice clinical counseling, clinical marriage and family therapy, clinical alcohol and drug counseling or clinical professional art therapy.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Certificate” means a certificate issued by the Board to practice as a:</text> <paragraph num="(a)"> <text>Certified professional counselor (CPC);</text> </paragraph> <paragraph num="(b)"> <text>Certified professional counselor-alcohol and drug (CPC-AD);</text> </paragraph> <paragraph num="(c)"> <text>Certified professional counselor-marriage and family therapy (CPC-MFT);</text> </paragraph> <paragraph num="(d)"> <text>Certified associate counselor-alcohol and drug (CAC-AD); or</text> </paragraph> <paragraph num="(e)"> <text>Certified supervised counselor-alcohol and drug (CSC-AD).</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Certificate holder” means a:</text> <paragraph num="(a)"> <text>Certified professional counselor;</text> </paragraph> <paragraph num="(b)"> <text>Certified alcohol and drug counselor;</text> </paragraph> <paragraph num="(c)"> <text>Certified supervised alcohol and drug counselor;</text> </paragraph> <paragraph num="(d)"> <text>Certified associate alcohol and drug counselor; or</text> </paragraph> <paragraph num="(e)"> <text>Certified professional counselor-marriage and family therapist.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Penalty” means a monetary penalty or fine.</text> </paragraph> <paragraph num="(8)"> <text>“Sanction” means a formal disciplinary action such as a reprimand, probation, suspension or revocation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Sanctioning and Imposition of Penalties."> <paragraph num="A."> <text>If, after a hearing or an opportunity for a hearing under Health Occupations Article, §17-511, Annotated Code of Maryland, the Board finds that there are grounds for discipline under Health Occupations Article, §17-509, Annotated Code of Maryland, the Board may place any licensee or certificate holder on probation, reprimand any licensee or certificate holder, or suspend or revoke a license or certificate.</text> </paragraph> <paragraph num="B."> <text>In addition to placing the licensee or certificate holder on probation, reprimanding the licensee or certificate holder, or suspending or revoking the license or certificate, the Board may impose a penalty as set forth in this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Guidelines for Disciplinary Sanctions and Penalties."> <paragraph num="A."> <text>General Application of Sanctioning Guidelines. Except as provided in Regulation .05 of this chapter, for violations of the Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines or more severe than the maximum listed in the guidelines for each offense.</text> </paragraph> <paragraph num="B."> <text>Ranking of Sanctions.</text> <paragraph num="(1)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Probation;</text> </paragraph> <paragraph num="(c)"> <text>Suspension; and</text> </paragraph> <paragraph num="(d)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(3)"> <text>A stayed suspension not meeting the criteria of §B(2) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(4)"> <text>A penalty listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction.</text> </paragraph> <paragraph num="(5)"> <text>The addition of a penalty does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may impose more than one sanction provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart.</text> </paragraph> <paragraph num="D."> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="E."> <text>If a licensee or certificate holder is found in violation of more than one ground for discipline as enumerated in this chapter, the sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction and the Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> <paragraph num="F."> <text>Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and licensee or certificate holder may agree to a surrender of license or certificate or to a consent order with terms, sanction, and penalty agreed to by the Board and the licensee or certificate holder.</text> </paragraph> <paragraph num="G."> <text>If the Board imposes a sanction that departs from the sanctioning guidelines set forth in this chapter, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Mitigating and Aggravating Factors."> <paragraph num="A."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines.</text> </paragraph> <paragraph num="B."> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="C."> <text>A departure from the guidelines set forth in this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="D."> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter.</text> <paragraph num="(1)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The offender self-reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The offender’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>The offender made timely good-faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(6)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>The absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>The absence of potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(9)"> <text>The offender’s conduct was an isolated incident and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mitigating factors may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(2)"> <text>The offender self-reported the violation to the Board;</text> </paragraph> <paragraph num="(3)"> <text>The offender’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(4)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(5)"> <text>The offender made timely good-faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(6)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(7)"> <text>The absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(8)"> <text>The absence of potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(9)"> <text>The offender’s conduct was an isolated incident and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(1)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(2)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(3)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(4)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(5)"> <text>The offender was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(6)"> <text>The vulnerability of the clients;</text> </paragraph> <paragraph num="(7)"> <text>The offender lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(8)"> <text>The offender committed the violation under the guise of treatment;</text> </paragraph> <paragraph num="(9)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(10)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(11)"> <text>Previous attempts at rehabilitation of the offender were unsuccessful.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>Subject to the provisions of Regulations .04 and .05 of this chapter, the Board may impose sanctions and penalties for violations of the Act and regulations according to the guidelines set forth in the following chart:</text> </paragraph> <paragraph num="B."> <text>Range of Sanctions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment of Penalty."> <paragraph num="A."> <text>A licensee or certificate holder shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="B."> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §17-512, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="C."> <text>If a licensee or certificate holder fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="D."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter into the State's General Fund.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 17-313.1, and 17-509—17-511, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 7, 2005 (32:22 Md. R. 1757)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective November 11, 2013 (40:22 Md. R. 1877)</annotation> </annotations> </chapter> <chapter num="10" heading="Compelling Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, and may disclose the information under the following circumstances:</text> <paragraph num="A."> <text>The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>The information concerns a possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>The information concerns conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §17-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 24, 2001 (28:25 Md. R. 2192)</annotation> </annotations> </chapter> <chapter num="11" heading="Advanced Assessment Activities"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter applies to licensees who practice clinical professional counseling, clinical marriage and family therapy, and clinical alcohol and drug counseling in this State.</text> </paragraph> <paragraph num="B."> <text>This chapter establishes standards for engaging in advanced assessment activities using instruments that require specialized psychological training for administration and interpretation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced assessment” means to use instruments that require specialized psychological training for administration and interpretation.</text> </paragraph> <paragraph num="(2)"> <text>Face-to-Face Supervision.</text> <paragraph num="(a)"> <text>“Face-to-face supervision” means in the physical presence of the individuals involved in the supervisory relationship during supervision.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face supervision” does not include:</text> <paragraph num="(i)"> <text>Telephone supervision; or</text> </paragraph> <paragraph num="(ii)"> <text>Video conferencing.</text> </paragraph> <paragraph num="(iii)"> <text>Internet communication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Supervisor who is proficient in the use of advanced assessment tests” means a licensed mental health professional approved by the Board, who:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, §§17-302, 17-303, and 17-304, Annotated Code of Maryland:</text> <paragraph num="(i)"> <text>Is qualified to practice clinical alcohol and drug counseling, clinical marriage and family therapy, or clinical professional counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Has completed the courses and supervised experience required by Health Occupations Article, §17-310(1) and (2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Has passed the National Counselors Examination (NCE) or another examination, as determined by the Board, that includes a comparable number of items assessing knowledge of advanced assessment procedures; and</text> </paragraph> <paragraph num="(iv)"> <text>Has 2 years experience practicing as a licensed clinical professional counselor, a licensed clinical marriage and family therapist, or a licensed clinical alcohol and drug counselor; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has 2 years of documented, professional experience in psychological testing or advanced assessment, as approved by the Board, using the modalities, principles, and procedures of advanced assessment, including, but not limited to:</text> <paragraph num="(i)"> <text>Teaching;</text> </paragraph> <paragraph num="(ii)"> <text>Counseling;</text> </paragraph> <paragraph num="(iii)"> <text>Clinical practice; and</text> </paragraph> <paragraph num="(iv)"> <text>Research modalities.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications."> <paragraph num="A."> <text>License. To engage in advanced assessment activities under this chapter, a licensee shall hold an active license in this State as a:</text> <paragraph num="(1)"> <text>Licensed clinical professional counselor;</text> </paragraph> <paragraph num="(2)"> <text>Licensed clinical marriage and family therapist;</text> </paragraph> <paragraph num="(3)"> <text>Licensed clinical alcohol and drug counselor; or</text> </paragraph> <paragraph num="(4)"> <text>Licensed clinical professional art therapist.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Education and Training.</text> <paragraph num="(1)"> <text>A licensee may engage in advanced assessment activities as defined in this chapter if the licensee has obtained a doctoral or master’s degree in counseling or a related field that includes a minimum of nine graduate courses of at least 3 semester hours or 5 quarter credit hours in each of the following courses listed in §B(2)—(10) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Psychopathology. Studies in this area shall include, but are not limited to, the scientific study of mental disorders and principles of abnormal psychology.</text> </paragraph> <paragraph num="(3)"> <text>Biological Bases of Behavior. Studies in this area shall include, but are not limited to, the biological, physiological, and neurological aspects of behavioral and mental disorders.</text> </paragraph> <paragraph num="(4)"> <text>Research Methods. Studies in this area shall include, but are not limited to, research methods for and principles of performing qualitative and quantitative research in the social sciences.</text> </paragraph> <paragraph num="(5)"> <text>Advanced Statistics. Studies in this area shall include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>Parametric and nonparametric statistics;</text> </paragraph> <paragraph num="(b)"> <text>Multivariate statistical methods, correlation, regression, factor analysis, and discriminate analysis; and</text> </paragraph> <paragraph num="(c)"> <text>Use of computers for data management and analysis.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Tests and Measures. Studies in this area shall include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>Test construction;</text> </paragraph> <paragraph num="(b)"> <text>Evaluation and documentation;</text> </paragraph> <paragraph num="(c)"> <text>Fairness in testing; and</text> </paragraph> <paragraph num="(d)"> <text>Testing applications.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Intellectual Assessment. Studies in this area shall include, but are not limited to, the construction, standardization, administration, scoring, and interpretation of intelligence tests.</text> </paragraph> <paragraph num="(8)"> <text>Personality Assessment. Studies in this area shall include, but are not limited to, the construction, standardization, scoring, and interpretation of personality tests.</text> </paragraph> <paragraph num="(9)"> <text>Ethics. Studies in this area shall include, but are not limited to the ethical, legal, and professional standards related to assessment and the practice of professional counseling or therapy.</text> </paragraph> <paragraph num="(10)"> <text>Practicum in Advanced Assessment. Studies in this area shall include, but are not limited to the following:</text> <paragraph num="(a)"> <text>Practice with clients in the use of advanced assessment tests;</text> </paragraph> <paragraph num="(b)"> <text>Practice in the scoring, interpretation, and reporting of results; and</text> </paragraph> <paragraph num="(c)"> <text>Practice in the integration of advanced assessment results with other sources of client information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Supervision. In order to engage in advanced assessment activities as defined in this chapter, a licensee shall also complete 500 hours of supervised, direct, client-related, advanced assessment testing that is fulfilled in not less than 2 years and after the award of the master’s degree, of which a minimum of 100 hours shall include face-to-face supervision by a supervisor who is proficient in the use of advanced assessment tests.</text> </paragraph> <paragraph num="D."> <text>Examination. In addition to meeting the requirements in §§A—C of this regulation, the licensee shall pass the National Counselors Examination (NCE) or another examination, as determined by the Board, that includes a comparable number of items assessing knowledge of advanced assessment procedures.</text> </paragraph> <paragraph num="E."> <text>Complaint. In the event the Board receives a complaint regarding a licensee’s engagement in the practice of advanced assessment or the use of instruments that require specialized psychological training for administration and interpretation, a licensee shall demonstrate compliance with the education, supervision, and examination requirements set forth in this chapter.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §17-310, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 15, 2010 (37:23 Md. R. 1611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 31, 2018 (45:26 Md. R. 1246)</annotation> </annotations> </chapter> <chapter num="12" heading="Licensed Clinical Professional Counselors — Requirements for Licensure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter:</text> <paragraph num="A."> <text>Establishes the requirements for an individual to practice clinical professional counseling;</text> </paragraph> <paragraph num="B."> <text>Establishes standards of supervision and the responsibilities of supervisors and supervisees in the practice of clinical professional counseling;</text> </paragraph> <paragraph num="C."> <text>Applies to licensees who:</text> <paragraph num="(1)"> <text>Practice clinical professional counseling; and</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision for licensed graduate professional counseling; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Applies to licensed graduate professional counselors who are in the process of obtaining the supervised clinical experience required by Health Occupations Article, §17-304.1, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means a Board-approved college or university accredited by a national or regional accrediting body recognized by the Council on Post-Secondary Accreditation or through one of the following bodies recognized by the U.S. Department of Education:</text> <paragraph num="(a)"> <text>The Middle States Association of Colleges and Schools — the Commission on Higher Education;</text> </paragraph> <paragraph num="(b)"> <text>The New England Association of Schools and Colleges;</text> </paragraph> <paragraph num="(c)"> <text>The North Central Association of Schools and Colleges;</text> </paragraph> <paragraph num="(d)"> <text>The Northwest Association of Schools and of Colleges and Universities;</text> </paragraph> <paragraph num="(e)"> <text>The Southern Association of Colleges and Schools; or</text> </paragraph> <paragraph num="(f)"> <text>The Western Association of Colleges and Schools.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Appraisal” means:</text> <paragraph num="(a)"> <text>Selecting, administering, scoring, and interpreting instruments designed to assess an individual's aptitudes, attitudes, abilities, achievements, interests, and personal characteristics; and</text> </paragraph> <paragraph num="(b)"> <text>Using nonstandardized methods and techniques for understanding human behavior in relation to coping with, adapting to, or changing life situations.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Board-approved supervisor” means:</text> <paragraph num="(a)"> <text>A licensed clinical professional counselor, licensed clinical marriage and family therapist, licensed clinical professional art therapist, or licensed clinical alcohol and drug counselor who meets the requirements for licensure under this chapter, and has been approved by the Board; or</text> </paragraph> <paragraph num="(b)"> <text>An individual who is authorized by law to practice a health occupation, which includes the diagnosis, prevention, treatment, and amelioration of psychological problems and emotional or mental conditions of individuals or groups, and has been approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Client contact hour” means at least 45 minutes of direct session time with a client present.</text> </paragraph> <paragraph num="(5)"> <text>“Clinical supervision hour” means at least 45 minutes of direct supervision time with the supervisee present.</text> </paragraph> <paragraph num="(6)"> <text>“Direct clinical counseling services” means the provision of face-to-face clinical professional counseling services to clients and their significant others that includes, but is not limited to the following:</text> <paragraph num="(a)"> <text>Individual counseling;</text> </paragraph> <paragraph num="(b)"> <text>Group counseling;</text> </paragraph> <paragraph num="(c)"> <text>Family counseling;</text> </paragraph> <paragraph num="(d)"> <text>Couples counseling;</text> </paragraph> <paragraph num="(e)"> <text>Evaluation;</text> </paragraph> <paragraph num="(f)"> <text>Intake or Assessment;</text> </paragraph> <paragraph num="(g)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(h)"> <text>Treatment planning with a client; and</text> </paragraph> <paragraph num="(i)"> <text>Crisis management or intervention.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Face-to-Face.</text> <paragraph num="(a)"> <text>“Face-to-face” means in the physical presence of an individual or using video conferencing which allows individuals to hear and see each other in synchronous points of time.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face” does not include:</text> <paragraph num="(i)"> <text>Telephone communication; or</text> </paragraph> <paragraph num="(ii)"> <text>Internet communication that does not involve synchronous video conferencing, such as instant messaging services and social networking sites.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Indirect clinical counseling services” means all case management and professional development activities related to the provision of clinical professional counseling services to a client that include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>Referral;</text> </paragraph> <paragraph num="(b)"> <text>Intake or assessment by telephone or other means when client is not face-to-face;</text> </paragraph> <paragraph num="(c)"> <text>Receiving individual and group supervision at site or at the university;</text> </paragraph> <paragraph num="(d)"> <text>Consultation with other professionals;</text> </paragraph> <paragraph num="(e)"> <text>Treatment planning with other professionals;</text> </paragraph> <paragraph num="(f)"> <text>Case staffing;</text> </paragraph> <paragraph num="(g)"> <text>Staff meetings;</text> </paragraph> <paragraph num="(h)"> <text>Related trainings and seminars;</text> </paragraph> <paragraph num="(i)"> <text>Record keeping;</text> </paragraph> <paragraph num="(j)"> <text>Report writing;</text> </paragraph> <paragraph num="(k)"> <text>Case note taking;</text> </paragraph> <paragraph num="(l)"> <text>Providing clinical training;</text> </paragraph> <paragraph num="(m)"> <text>Telephone triage;</text> </paragraph> <paragraph num="(n)"> <text>Case management;</text> </paragraph> <paragraph num="(o)"> <text>Program development; and</text> </paragraph> <paragraph num="(p)"> <text>Other clinical professional counselor administrative duties as required by the setting in which the clinical hours are accrued.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Licensed clinical professional counselor” means an individual approved by the Board to practice clinical professional counseling.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed graduate professional counselor” means an individual approved by the Board to practice graduate professional counseling:</text> <paragraph num="(a)"> <text>Under the supervision of a Board-approved supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>While fulfilling the supervised clinical experience for licensure under:</text> <paragraph num="(i)"> <text>Health Occupations Article, §17-304, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulation .04 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Practice clinical professional counseling” means:</text> <paragraph num="(a)"> <text>To engage professionally and for compensation in clinical professional counseling and appraisal activities by providing services involving the application of clinical professional counseling principles and methods in the diagnosis, crisis management, prevention, treatment, and amelioration of psychological problems, and emotional or mental conditions of individuals or groups; and</text> </paragraph> <paragraph num="(b)"> <text>The use of instruments that require specialized psychological training for administration and interpretation as described in Health Occupations Article, §17-310, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Practice graduate professional counseling” means to practice clinical professional counseling:</text> <paragraph num="(a)"> <text>Under the supervision of a Board-approved supervisor; and</text> </paragraph> <paragraph num="(b)"> <text>While fulfilling the requirements for supervised experience under:</text> <paragraph num="(i)"> <text>Health Occupations Article, §17-304, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>Regulation .04 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Psychotherapy” means providing clinical services which involve:</text> <paragraph num="(a)"> <text>The professional application of psychotherapy and counseling theories and methods, including but not limited to psychodynamic, cognitive, behavioral, humanistic, systems theories, or trauma informed care to assist the client in:</text> <paragraph num="(i)"> <text>Improving functioning;</text> </paragraph> <paragraph num="(ii)"> <text>Obtaining symptom relief;</text> </paragraph> <paragraph num="(iii)"> <text>Preventing psychosocial dysfunction;</text> </paragraph> <paragraph num="(iv)"> <text>Changing personality; or</text> </paragraph> <paragraph num="(v)"> <text>Maintaining improved functioning; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Situations in which the principal discourse involves, but is not limited to:</text> <paragraph num="(i)"> <text>Diagnosis of psychopathology based on standard diagnostic criteria;</text> </paragraph> <paragraph num="(ii)"> <text>Psychotherapeutic treatment of mental disorders, emotional disorders, and adjustment reactions utilizing clinically appropriate treatment modalities;</text> </paragraph> <paragraph num="(iii)"> <text>Childhood trauma and abuse;</text> </paragraph> <paragraph num="(iv)"> <text>Identifying and changing self-defeating patterns of behaving, thinking, feeling, believing, or interacting with others in systems;</text> </paragraph> <paragraph num="(v)"> <text>Developmental issues;</text> </paragraph> <paragraph num="(vi)"> <text>Personality development; or</text> </paragraph> <paragraph num="(vii)"> <text>Problems related to disorders of thinking, emotional suffering, addictions, behavior, or interpersonal dysfunctions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Related field” means a profession using counseling whose academic requirements include degree programs from an accredited college or university that has curricula in areas such as expressive therapy, gerontology, human services, marriage and family therapy, mental health, pastoral counseling, psychology, psychotherapy, social work, and other areas approved by the Board.</text> </paragraph> <paragraph num="(15)"> <text>“Relative” means an individual connected to another by:</text> <paragraph num="(a)"> <text>Blood;</text> </paragraph> <paragraph num="(b)"> <text>Marriage;</text> </paragraph> <paragraph num="(c)"> <text>Guardianship; or</text> </paragraph> <paragraph num="(d)"> <text>Domestic partnership.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Supervised clinical experience in clinical professional counseling” means counseling services conducted under the supervision of a Board-approved supervisor.</text> </paragraph> <paragraph num="(17)"> <text>“Supervisee” means a licensed graduate professional counselor obtaining the supervised experience required by Health Occupations Article, §17-304, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Supervision” means a formalized professional relationship between a supervisor and supervisee in which the supervisor directs, guides, monitors, instructs, and evaluates the supervisee’s clinical professional counseling practice while promoting development of the supervisee’s knowledge, skills, and abilities to provide clinical professional counseling services in an ethical and competent manner and includes an acceptance of direct responsibility for the client services rendered by the supervisee.</text> </paragraph> <paragraph num="(19)"> <text>Supervision Training.</text> <paragraph num="(a)"> <text>“Supervision training” means a course or program designed to provide information regarding the clinical supervision process utilized by licensed clinical professional counselors in a variety of settings.</text> </paragraph> <paragraph num="(b)"> <text>“Supervision training” includes training obtained through:</text> <paragraph num="(i)"> <text>Graduate-level course work;</text> </paragraph> <paragraph num="(ii)"> <text>Continuing education units (CEUs); or</text> </paragraph> <paragraph num="(iii)"> <text>Other training hours approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Under the supervision of a Board-approved supervisor” means engaging in an ongoing process of receiving direction from a Board-approved supervisor that includes:</text> <paragraph num="(a)"> <text>Monitoring the performance of a supervisee; and</text> </paragraph> <paragraph num="(b)"> <text>Documented and direct consultation, guidance, and instruction with respect to clinical skill and competency.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Written contract for supervision” means a Board-approved agreement between the supervisee and approved supervisor that is initiated before beginning supervision and that details the scope of supervision and includes at a minimum the following:</text> <paragraph num="(a)"> <text>Name and credentials of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(b)"> <text>Primary purpose, goals, and objectives of the supervision process;</text> </paragraph> <paragraph num="(c)"> <text>Details of provisions, including frequency, format, and case or chart review;</text> </paragraph> <paragraph num="(d)"> <text>Methods of documentation;</text> </paragraph> <paragraph num="(e)"> <text>Duties and responsibilities of the supervisor and the supervisee;</text> </paragraph> <paragraph num="(f)"> <text>Procedural considerations in the case of the supervisor’s absence; and</text> </paragraph> <paragraph num="(g)"> <text>Information regarding the supervisor’s scope of competence.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application Process for Licensure."> <paragraph num="A."> <text>In order to obtain a license, an applicant shall:</text> <paragraph num="(1)"> <text>Complete and return the Board-approved application;</text> </paragraph> <paragraph num="(2)"> <text>Submit an official transcript from an accredited educational institution awarding the highest degree attained in a clinical professional counseling or related field;</text> </paragraph> <paragraph num="(3)"> <text>Pay all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(4)"> <text>Submit to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Be of good moral character; and</text> </paragraph> <paragraph num="(6)"> <text>Be at least 18 years old.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Applications shall be acted upon as follows:</text> <paragraph num="(1)"> <text>Within 30 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of the notice, the applicant shall correct the deficiency within 90 days, or other period specified in the notice;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the Board determines that an applicant is eligible to take the required examinations, the Board shall send a notice of approval to the applicant;</text> </paragraph> <paragraph num="(6)"> <text>Upon receipt of the approval notice, the applicant shall have 1 year from the date of the notice to take the examinations; and</text> </paragraph> <paragraph num="(7)"> <text>If the applicant fails to take the examinations within 1 year from the date of the approval notice, the requirements set forth under §B(4) of this regulation shall apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensed Graduate Professional Counselors."> <paragraph num="A."> <text>To qualify for licensure as a graduate professional counselor, an applicant shall have:</text> <paragraph num="(1)"> <text>Completed one of the following from an accredited educational institution:</text> <paragraph num="(a)"> <text>A master's degree in a clinical professional counseling or related field with:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate semester credit hours, or, if the master’s program provides less than 60 graduate semester credit hours, requirements may be met by completing additional graduate courses as approved by the Board; or</text> </paragraph> <paragraph num="(ii)"> <text>90 graduate quarter credit hours; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A doctoral degree in a clinical professional counseling or related field with:</text> <paragraph num="(i)"> <text>A minimum of 90 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>135 graduate quarter credit hours;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 3 semester credit hours or the equivalent quarter credit hours of course work in each of the following course content areas:</text> <paragraph num="(a)"> <text>Human growth and personality development;</text> </paragraph> <paragraph num="(b)"> <text>Social and cultural foundations of counseling;</text> </paragraph> <paragraph num="(c)"> <text>Counseling theory;</text> </paragraph> <paragraph num="(d)"> <text>Counseling techniques;</text> </paragraph> <paragraph num="(e)"> <text>Group dynamics, processing, and counseling;</text> </paragraph> <paragraph num="(f)"> <text>Lifestyle and career development;</text> </paragraph> <paragraph num="(g)"> <text>Appraisal;</text> </paragraph> <paragraph num="(h)"> <text>Research and evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Professional, legal, and ethical responsibilities;</text> </paragraph> <paragraph num="(j)"> <text>Marriage and family therapy;</text> </paragraph> <paragraph num="(k)"> <text>Supervised field experience that includes a:</text> <paragraph num="(i)"> <text>Supervised clinical internship, externship, field experience, or practicum placement; and</text> </paragraph> <paragraph num="(ii)"> <text>Minimum of 125 direct clinical counseling service hours;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Alcohol and drug counseling;</text> </paragraph> <paragraph num="(m)"> <text>Psychopathology; and</text> </paragraph> <paragraph num="(n)"> <text>Diagnosis and treatment of mental and emotional disorders;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(5)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="D."> <text>A licensed graduate professional counselor shall practice clinical professional counseling under the supervision of a Board-approved supervisor.</text> </paragraph> <paragraph num="E."> <text>A licensed graduate professional counselor may not:</text> <paragraph num="(1)"> <text>Practice independent of supervision; or</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Expiration and Extension.</text> <paragraph num="(1)"> <text>The graduate professional counselor license expires 2 years after the date issued.</text> </paragraph> <paragraph num="(2)"> <text>If the graduate professional counselor licensee is unable to accumulate the required clinical hours for licensure as a clinical professional counselor in 2 years, the graduate professional counselor may apply on a Board-approved form for a 2-year extension before the current license expiration, up to a maximum of 6 years, except as provided in §F(4) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>For a graduate professional counselor who has been granted a 2-year extension, CEUs are not required for the first 2-year extension. Subsequent extensions approved by the Board shall be subject to the continuing education requirements in COMAR 10.58.05.</text> </paragraph> <paragraph num="(4)"> <text>A graduate professional counselor shall submit a written request for an extension beyond the 6-year maximum, which the Board may grant in certain circumstances.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the license renewal date, the Board may reinstate the license of a licensed graduate professional counselor otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes within that 5-year period the minimum of 20 CEUs required for each year; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the reinstatement fee set by the Board in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and.06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed graduate professional counselor whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice graduate professional counseling.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensed Clinical Professional Counselors."> <paragraph num="A."> <text>To qualify for licensure as a clinical professional counselor the applicant shall have:</text> <paragraph num="(1)"> <text>A graduate professional counselor license or other credential approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>For an applicant holding a master’s degree, completed a minimum of 3 years and 3,000 hours of experience in clinical professional counseling, of which:</text> <paragraph num="(a)"> <text>A minimum of the 1,500 hours shall be direct clinical counseling services;</text> </paragraph> <paragraph num="(b)"> <text>A maximum of 1,500 hours may consist of indirect clinical counseling services;</text> </paragraph> <paragraph num="(c)"> <text>A minimum of 2,000 hours of supervised clinical experience as a licensed graduate professional counselor shall be completed after the awarding of the master's degree under a Board-approved supervisor;</text> </paragraph> <paragraph num="(d)"> <text>A maximum of 1,000 hours of supervised clinical experience may be acquired as supervised field experience as defined under Regulation .04A(2)(k) of this chapter;</text> </paragraph> <paragraph num="(e)"> <text>At least half of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under the supervision of a Board-approved supervisor who is a licensed clinical professional counselor;</text> </paragraph> <paragraph num="(f)"> <text>No more than half of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under a Board-approved supervisor as defined in Regulation .02Bof this chapter; and</text> </paragraph> <paragraph num="(g)"> <text>100 hours of face-to-face clinical supervision hours shall be completed within 2 years of the awarding of the master’s degree, of which:</text> <paragraph num="(i)"> <text>A minimum of 50 hours shall be individual face-to-face clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>A maximum of 50 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>For an applicant holding a doctoral degree, completed a minimum of 2,000 hours of experience in clinical professional counseling, of which:</text> <paragraph num="(a)"> <text>A minimum of 1,000 hours shall be face-to-face direct clinical counseling services and a maximum of 1,000 hours may consist of indirect clinical counseling services;</text> </paragraph> <paragraph num="(b)"> <text>1,000 hours shall be acquired after the doctoral degree has been awarded;</text> </paragraph> <paragraph num="(c)"> <text>A maximum of 1,000 hours of clinical experience may be acquired before the awarding of the doctoral degree;</text> </paragraph> <paragraph num="(d)"> <text>At least half of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under the supervision of a Board-approved supervisor who is a licensed clinical professional counselor;</text> </paragraph> <paragraph num="(e)"> <text>No more than half of the requisite direct and indirect hours included as supervised clinical experience hours shall be completed under a Board-approved supervisor as defined in Regulation .02Bof this chapter; and</text> </paragraph> <paragraph num="(f)"> <text>50 hours of face-to-face clinical supervision hours shall be completed within 1 year of the awarding of the doctoral degree, including:</text> <paragraph num="(i)"> <text>25 hours shall be individual face-to-face clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>A maximum of 25 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Completed the required course work set forth under Regulation .04A(2) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>This subtitle;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Met all of the requirements set forth under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure:</text> <paragraph num="(1)"> <text>May retake the exam if:</text> <paragraph num="(a)"> <text>It is within the time frame set by the applicable testing authority; or</text> </paragraph> <paragraph num="(b)"> <text>A waiver is approved by the Board to extend the testing deadline upon proof of exceptional circumstances; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall act upon applications as set forth under Regulation .03B of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board may include hours of clinical supervised experience obtained in another jurisdiction toward the total 3,000 required hours of supervised experience required for the licensed clinical professional counselor, if the clinical experience hours:</text> <paragraph num="(1)"> <text>Were obtained in accordance with the rules and regulations of that jurisdiction; and</text> </paragraph> <paragraph num="(2)"> <text>Included the course work requirements set forth under Regulation .06D of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew a clinical professional counselor license, the applicant shall:</text> <paragraph num="(a)"> <text>Submit a completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required application fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed clinical professional counselor shall comply with the renewal requirements as provided in Health Occupations Article, §17–504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to renew licensure is not authorized to and may not practice clinical professional counseling.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the license renewal date, the Board may reinstate the license of a licensed clinical professional counselor otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes within that 5-year period the minimum of 20 CEUs required for each year; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the reinstatement fee set by the Board in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and .06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed clinical professional counselor whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice clinical professional counseling.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §17-505, Annotated Code of Maryland, a request to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(a)"> <text>Completed Board-approved application; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of the required, nonrefundable, annual fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual may apply for inactive status only if the individual’s license is still active at the time application for inactive status is made.</text> </paragraph> <paragraph num="(3)"> <text>An individual on inactive status is not authorized to and may not practice clinical professional counseling.</text> </paragraph> <paragraph num="(4)"> <text>Within 5 calendar years after being placed on inactive status, an individual seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed 20 CEUs for each year of inactive status, at least 40 of which shall have been obtained within the 2-year period immediately preceding the application for reinstatement.</text> </paragraph> <paragraph num="(5)"> <text>If an individual on inactive status seeks to be reinstated beyond the required 5-year period and conditions set forth under §G(4) of this regulation, the individual shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the nonrefundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Licensure Eligibility: Out-of-State Applicants."> <paragraph num="A."> <text>An applicant licensed as a clinical professional counselor or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for licensure if the applicant:</text> <paragraph num="(1)"> <text>Provides:</text> <paragraph num="(a)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>An official transcript from the educational institution which awarded the master’s or doctoral degree;</text> </paragraph> <paragraph num="(c)"> <text>A copy of a current license from each state, territory, or jurisdiction in which the applicant has been licensed, registered, or otherwise authorized to practice clinical professional counseling;</text> </paragraph> <paragraph num="(d)"> <text>Documentation, satisfactory to the Board, that the applicant is currently licensed in good standing to practice clinical professional counseling in another state, territory, or jurisdiction; and</text> </paragraph> <paragraph num="(e)"> <text>Verification that the applicant has:</text> <paragraph num="(i)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a license to practice clinical professional counseling; and</text> </paragraph> <paragraph num="(ii)"> <text>Not committed any act or omission that would be grounds for discipline or denial of licensure under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pays the application fee set forth in the COMAR 10.58.02;</text> </paragraph> <paragraph num="(3)"> <text>Has achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification examination approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submits to a criminal history background check in accordance with Health Occupations Article, §17-501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Meets the educational requirements for licensure in this State as a clinical professional counselor:</text> <paragraph num="(a)"> <text>As established in Regulation .05 of this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>By providing documentation of the substitute educational and experience requirements outlined in §§B—E of this regulation;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is of good moral character; and</text> </paragraph> <paragraph num="(7)"> <text>Complies with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver of Examination. The Board may waive any examination requirements for an applicant who satisfies the Board that the applicant:</text> <paragraph num="(1)"> <text>Obtained licensure in a state or country that grants a similar endorsement to licensees of this State;</text> </paragraph> <paragraph num="(2)"> <text>Became licensed in another state or country after passing an examination approved by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Meets the qualifications otherwise required by Health Occupations Article, Title 17, Annotated Code of Maryland, and this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Equivalent Educational Requirements. The applicant shall provide documentation or transcripts confirming completion of a master's or doctoral degree in a professional counseling field from an accredited educational institution.</text> </paragraph> <paragraph num="D."> <text>Waiver of Course Requirements. The Board may waive one or more course requirements specified in Regulation .04 of this chapter, except for documentation showing completion of a minimum of 3 graduate semester credit hours or the equivalent graduate quarter hours covering each of the following primary topics or content areas:</text> <paragraph num="(1)"> <text>Diagnosis and psychopathology;</text> </paragraph> <paragraph num="(2)"> <text>Psychotherapy and treatment of mental and emotional disorders, as described in Regulation .02Bof this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Professional, legal, and ethical responsibilities.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Equivalent Experience Requirements. The Board may waive the clinical experience requirements specified in Regulation .04 of this chapter as follows:</text> <paragraph num="(1)"> <text>The applicant shall provide documentation, satisfactory to the Board, of one of the following for an applicant with:</text> <paragraph num="(a)"> <text>A master's degree consisting of:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate credit hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Not less than 3 years, with a minimum of 3,000 hours, of supervised clinical experience in clinical professional counseling, 2 years of which shall be completed after the award of the master's degree;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A master's degree consisting of:</text> <paragraph num="(i)"> <text>Less than 60 graduate credit hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Not less than 3 years’ experience practicing as a licensed clinical professional counselor, with a minimum of 3,000 hours of clinical professional counseling experience; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A doctoral degree consisting of:</text> <paragraph num="(i)"> <text>Not less than 2 years practicing as a clinical professional counselor; or</text> </paragraph> <paragraph num="(ii)"> <text>A minimum of 2,000 hours of clinical professional counseling experience; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The applicant shall provide verification, on a Board-approved form, from employers, supervisors, or colleagues that the applicant has practiced clinical professional counseling for the length of time stated in §E(1) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standards for Supervision."> <paragraph num="A."> <text>Except as otherwise specified in this chapter, this chapter does not apply to personnel or management practices associated with contractual relationships or employment.</text> </paragraph> <paragraph num="B."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Supervise only in those areas within the supervisor’s competence as determined by education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision appropriate to the particular level of licensure being applied for or maintained;</text> </paragraph> <paragraph num="(3)"> <text>Provide supervision in the general content areas established in Health Occupations Article, §17-304, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>This subtitle, with special emphasis on the code of ethics under COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §B of this regulation, the supervisor shall specifically instruct and provide guidance:</text> <paragraph num="(1)"> <text>Relating to the supervisee’s scope of practice of clinical professional counseling under Health Occupations Article, §17-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>For services involving the application of therapy principles and methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions of individuals, families, couples or groups, as stated in Health Occupations Article, §17-308, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>To supervisees in appropriate billing practices, if applicable to the practice site, including:</text> <paragraph num="(a)"> <text>Record keeping;</text> </paragraph> <paragraph num="(b)"> <text>Disclosure of fees and financial arrangements; and</text> </paragraph> <paragraph num="(c)"> <text>Appropriate maintenance and destruction of clinical and financial records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>The following individuals may not provide clinical supervision for a licensed graduate professional counselor supervisee:</text> <paragraph num="(1)"> <text>A relative; or</text> </paragraph> <paragraph num="(2)"> <text>An individual with whom there could be a conflict of interest, including, but not limited to:</text> <paragraph num="(a)"> <text>An employee supervising their own employer; or</text> </paragraph> <paragraph num="(b)"> <text>A student supervising their own teacher.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Supervisor Qualifications."> <paragraph num="A."> <text>Licensure. An individual providing supervision shall be approved by the Board and licensed by the Board as a:</text> <paragraph num="(1)"> <text>Clinical professional counselor;</text> </paragraph> <paragraph num="(2)"> <text>Clinical professional art therapist;</text> </paragraph> <paragraph num="(3)"> <text>Clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(4)"> <text>Clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(5)"> <text>Mental health care provider as defined in Regulation .02B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Experience, Education, and Training.</text> <paragraph num="(1)"> <text>A Board-approved supervisor shall have completed 2 years of active clinical practice experience:</text> <paragraph num="(a)"> <text>In clinical professional counseling, marriage and family therapy, professional art therapy, or alcohol and drug counseling;</text> </paragraph> <paragraph num="(b)"> <text>As a clinical professional counselor, marriage and family therapist, professional art therapist, or alcohol and drug counselor licensed or certified in another state, territory or jurisdiction that has requirements that are equivalent to or exceed the requirements of Health Occupations Article, §§17-302—17-304.1, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>As another licensed mental health care provider as defined in Regulation .02Bof this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A Board-approved supervisor shall have completed one of the following education and training experiences:</text> <paragraph num="(a)"> <text>At least 3 graduate semester credit hours or the equivalent quarter credit hours of academic course work in clinical supervision;</text> </paragraph> <paragraph num="(b)"> <text>A Board-approved continuing education program that includes a minimum of 18 continuing education units (CEUs) in:</text> <paragraph num="(i)"> <text>Clinical professional counseling supervision; or</text> </paragraph> <paragraph num="(ii)"> <text>Another behavioral health profession that is authorized to diagnose and treat mental and emotional disorders;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The National Board of Certified Counselors (NBCC) Approved Clinical Supervisor (ACS) credential; or</text> </paragraph> <paragraph num="(d)"> <text>Supervision training as defined in Regulation .02Bof this chapter.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Supervision training required by this section may be obtained in a graduate course or a continuing education program as required under §B(2)(b) of this regulation that may include, but is not limited to:</text> <paragraph num="(a)"> <text>The role and responsibilities of the supervisor;</text> </paragraph> <paragraph num="(b)"> <text>The needs of the supervisee, supervisor, and the agency setting while maintaining a clear ethical perspective, including:</text> <paragraph num="(i)"> <text>The maintenance of appropriate boundaries; and</text> </paragraph> <paragraph num="(ii)"> <text>Making clinically appropriate diagnoses;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The role of the supervisor as gatekeeper to the profession;</text> </paragraph> <paragraph num="(d)"> <text>Methods for building effective and appropriate relationships with clients;</text> </paragraph> <paragraph num="(e)"> <text>Models for group supervision; and</text> </paragraph> <paragraph num="(f)"> <text>Models and modalities for practice intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-Supervision Responsibilities of a Supervisor. In addition to meeting the requirements of this regulation, the Board-approved supervisor shall:</text> <paragraph num="(1)"> <text>File the completed Board-approved supervisor application form;</text> </paragraph> <paragraph num="(2)"> <text>Provide the supervisee with a copy of the Board’s licensed clinical professional counselor supervisor letter; and</text> </paragraph> <paragraph num="(3)"> <text>Have an active license that is without restrictions or conditions due to disciplinary action for the 2 years preceding an application for Board-approved supervisor status.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisor may be:</text> <paragraph num="(1)"> <text>An agency-designated supervisor; or</text> </paragraph> <paragraph num="(2)"> <text>An independent supervisor in private practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supervisor Responsibilities."> <text>A supervisor shall:</text> <paragraph num="A."> <text>Agree to and sign a written contract for supervision before initiating supervision;</text> </paragraph> <paragraph num="B."> <text>Ensure that the supervisee is practicing within the scope of the supervisee’s license;</text> </paragraph> <paragraph num="C."> <text>Determine the skill level at which the supervisee may practice;</text> </paragraph> <paragraph num="D."> <text>Focus on primary data from the supervisee’s practice;</text> </paragraph> <paragraph num="E."> <text>Maintain documentation of supervisory sessions for at least 7 years, including:</text> <paragraph num="(1)"> <text>Dates;</text> </paragraph> <paragraph num="(2)"> <text>Duration; and</text> </paragraph> <paragraph num="(3)"> <text>Focus of the supervisory sessions;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>This subtitle with special emphasis on the code of ethics under COMAR 10.58.03;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Within a reasonable period of time before the conclusion of supervision, provide the supervisee and employer with a notice of termination to avoid or minimize any harmful effect on the supervisee’s clients or patients;</text> </paragraph> <paragraph num="H."> <text>Be responsible for the clinical professional practices of supervisees;</text> </paragraph> <paragraph num="I."> <text>Provide:</text> <paragraph num="(1)"> <text>For emergency supervision of and direction to a supervisee by a Board-approved supervisor;</text> </paragraph> <paragraph num="(2)"> <text>A written evaluation of progress to the supervisee on a regular basis or as needed; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the documentation required by §E of this regulation on request by the:</text> <paragraph num="(a)"> <text>Supervisee; or</text> </paragraph> <paragraph num="(b)"> <text>Board or its authorized agent; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Comply with a Board audit of a Board-approved supervisor’s compliance with regard to the supervisory requirements and responsibilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Supervisee Responsibilities."> <paragraph num="A."> <text>A supervisee shall:</text> <paragraph num="(1)"> <text>Verify that the supervisor has been approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Agree to and sign a Board-approved contract before initiating supervision;</text> </paragraph> <paragraph num="(3)"> <text>Attend and participate in supervision as agreed to in the supervision contract;</text> </paragraph> <paragraph num="(4)"> <text>Prepare for supervision using case materials related to the supervisee’s clinical professional counseling practice;</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of supervisory sessions for at least 7 years, to be available for verification to the Board or its authorized agent, including:</text> <paragraph num="(a)"> <text>Dates;</text> </paragraph> <paragraph num="(b)"> <text>Duration; and</text> </paragraph> <paragraph num="(c)"> <text>Focus of the supervision; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Follow all terms of the written contract for supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisee may not engage in the practice of clinical professional counseling independent of supervision.</text> </paragraph> <paragraph num="C."> <text>A supervisee shall give the client a copy of a professional disclosure statement as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states the counseling services are provided under clinical supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name of the supervisor with address and contact information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisee shall obtain from the client a signed:</text> <paragraph num="(1)"> <text>Release of information; and</text> </paragraph> <paragraph num="(2)"> <text>Informed consent for treatment which indicates that the client:</text> <paragraph num="(a)"> <text>Is aware that counseling services are being provided under clinical supervision;</text> </paragraph> <paragraph num="(b)"> <text>Consents to the recording of counseling sessions with the knowledge that the recording may only be shared with the supervisor; and</text> </paragraph> <paragraph num="(c)"> <text>Consents to the sharing of client information between the licensed graduate professional counselor and the named clinical supervisor.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-101 17-205, 17-301, 17-304, 17-307, and 17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 22, 2011 (38:17 Md. R. 1013)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 under Supervision Requirements repealed and new Regulations .01—.10 under Licensed Clinical Professional Counselors — Requirements for Licensure adopted effective June 28, 2021 (48:13 Md. R. 508)</annotation> </annotations> </chapter> <chapter num="13" heading="Supervision Requirements for Licensed Graduate Alcohol and Drug Counselors and Graduate-Level Trainees" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: November 11, 2013 (40:22 Md. R. 1877)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed effective June 28, 2021 (48:13 Md. R. 508)</annotation> </annotations> </chapter> <chapter num="14" heading="Supervision Requirements for Certified Alcohol and Drug Counselors and Trainees Pursuing Certification" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: November 11, 2013 (40:22 Md. R. 1878)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 repealed effective June 28, 2021 (48:13 Md. R. 508)</annotation> </annotations> </chapter> <chapter num="15" heading="Supervision Requirements for Licensed Clinical Marriage and Family Therapists and Licensed Graduate Marriage and Family Therapists" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 8, 2016 (43:24 Md. R. 1351)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 8, 2016 (43:24 Md. R. 1351)</annotation> <annotation type="History" subtype="Administrative History">Chapter repealed effective April 4, 2022 (49:7 Md. R. 467)</annotation> </annotations> </chapter> <chapter num="16" heading="Behavior Analyst Advisory Committee"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the practice of behavior analysis.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Professional Counselors and Therapists.</text> </paragraph> <paragraph num="(3)"> <text>“Board-certified assistant behavior analyst” means an individual who:</text> <paragraph num="(a)"> <text>Is credentialed by the Behavior Analyst Certification Board or a successor organization; and</text> </paragraph> <paragraph num="(b)"> <text>Practices under the supervision of a licensed behavior analyst in accordance with the Behavior Analyst Certification Board's description of the role and functions of a board-certified assistant behavior analyst and supervision requirements.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Board-certified behavior analyst” means an individual credentialed by the Behavior Analyst Certification Board or a successor organization.</text> </paragraph> <paragraph num="(5)"> <text>“Committee” means the Behavior Analyst Advisory Committee.</text> </paragraph> <paragraph num="(6)"> <text>“In-person” means within the physical presence of the individual receiving behavior analyst services or the individual’s caregiver.</text> </paragraph> <paragraph num="(7)"> <text>“License” means a license issued by the Board to practice behavior analysis.</text> </paragraph> <paragraph num="(8)"> <text>“Licensed behavior analyst” means a behavior analyst licensed by the Board to practice behavior analysis.</text> </paragraph> <paragraph num="(9)"> <text>“Paraprofessional” means an individual who:</text> <paragraph num="(a)"> <text>Practices behavior analysis under the supervision of a licensed behavior analyst in accordance with requirements set by the Behavior Analyst Certification Board; and</text> </paragraph> <paragraph num="(b)"> <text>Is not a board-certified assistant behavior analyst; and</text> </paragraph> <paragraph num="(c)"> <text>May be a registered behavior technician.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Practice Behavior Analysis.</text> <paragraph num="(a)"> <text>“Practice behavior analysis” means to design, implement, and evaluate systematic instructional and environmental modifications to produce socially significant improvements in human behavior.</text> </paragraph> <paragraph num="(b)"> <text>“Practice behavior analysis” includes:</text> <paragraph num="(i)"> <text>The empirical identification of functional relations between behavior and environmental factors, also known as functional assessment and analysis; and</text> </paragraph> <paragraph num="(ii)"> <text>Interventions based on scientific research and the direct observation and measurement of behavior and environment.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Practice behavior analysis” does not include:</text> <paragraph num="(i)"> <text>Psychological testing;</text> </paragraph> <paragraph num="(ii)"> <text>Diagnosis of a mental or physical disorder;</text> </paragraph> <paragraph num="(iii)"> <text>Neuropsychology;</text> </paragraph> <paragraph num="(iv)"> <text>Psychotherapy;</text> </paragraph> <paragraph num="(v)"> <text>Cognitive therapy;</text> </paragraph> <paragraph num="(vi)"> <text>Sex therapy;</text> </paragraph> <paragraph num="(vii)"> <text>Psychoanalysis or hypnotherapy; or</text> </paragraph> <paragraph num="(viii)"> <text>Counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Registered behavior technician” means an individual who:</text> <paragraph num="(a)"> <text>Is credentialed as a registered behavior technician by the Behavior Analyst Certification Board or a successor organization; and</text> </paragraph> <paragraph num="(b)"> <text>Practices behavior analysis under the close, ongoing supervision of a licensed behavior analyst in accordance with requirements set by the Behavior Analyst Certification Board.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Supervisee” means an individual who implements behavior analytic assessment or intervention procedures under the supervision of a licensed behavior analyst. Supervisees include, but are not limited to:</text> <paragraph num="(a)"> <text>Board-Certified Assistant Behavior Analysts;</text> </paragraph> <paragraph num="(b)"> <text>Paraprofessionals;</text> </paragraph> <paragraph num="(c)"> <text>Matriculated undergraduate or graduate students engaging in behavior analytic activities to fulfill requirements for coursework, practica, internships, theses, dissertations, graduate assistantships, or independent study; and</text> </paragraph> <paragraph num="(d)"> <text>Non-students who are completing the supervised experiential training eligibility requirement for certification by the Behavior Analyst Certification Board.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Supervision” means:</text> <paragraph num="(a)"> <text>The ongoing monitoring of implementation quality, the frequency of which should be based on the supervisee’s</text> <paragraph num="(i)"> <text>Training;</text> </paragraph> <paragraph num="(ii)"> <text>Competence; and</text> </paragraph> <paragraph num="(iii)"> <text>Experience;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The nature of the assessment or intervention procedures delegated to the supervisee; and</text> </paragraph> <paragraph num="(c)"> <text>Meeting the minimum supervision requirements of the Behavior Analyst Certification Board.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Supervisor” means a licensed behavior analyst who:</text> <paragraph num="(a)"> <text>Provides supervision to a supervisee; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the minimum supervision requirements of the Behavior Analyst Certification Board.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(16)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Telehealth practitioner” means an individual authorized to provide telehealth services in Maryland pursuant to Health Occupations Article, Title 17, Subtitle 6A, Annotated Code of Maryland, who performs telehealth services within their respective scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Behavior Analyst Advisory Committee."> <paragraph num="A."> <text>The Board shall appoint members of the committee as follows:</text> <paragraph num="(1)"> <text>On or before December 31, 2014, four behavior analysts who:</text> <paragraph num="(a)"> <text>Are credentialed by the Behavior Analyst Certification Board as board-certified behavior analysts or designated as board-certified behavior analysts-doctoral; and</text> </paragraph> <paragraph num="(b)"> <text>Have a minimum of 5 years of clinical experience; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>On or after January 1, 2015, four licensed behavior analysts who:</text> <paragraph num="(a)"> <text>Are credentialed by the Behavior Analyst Certification Board; and</text> </paragraph> <paragraph num="(b)"> <text>Have a minimum of 5 years of clinical experience; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One consumer member who:</text> <paragraph num="(a)"> <text>Is a member of the general public;</text> </paragraph> <paragraph num="(b)"> <text>Is receiving or has received applied behavior analysis services, or has a child who is receiving or has received applied behavior analysis services; and</text> </paragraph> <paragraph num="(c)"> <text>May not:</text> <paragraph num="(i)"> <text>Be or ever have been a behavior analyst or in training to become a behavior analyst;</text> </paragraph> <paragraph num="(ii)"> <text>Have a household member who is a behavior analyst or in training to become a behavior analyst;</text> </paragraph> <paragraph num="(iii)"> <text>Participate or ever have participated in a commercial or professional field related to behavior analysis;</text> </paragraph> <paragraph num="(iv)"> <text>Have a household member who participates in a commercial or professional field related to behavior analysis; and</text> </paragraph> <paragraph num="(v)"> <text>Have had within 2 years before appointment a substantial financial interest in a person regulated by the Board.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Terms.</text> <paragraph num="(1)"> <text>The term of a member is 4 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of members are staggered.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed and qualifies.</text> </paragraph> <paragraph num="(4)"> <text>An individual may be reappointed for a second 4-year term, but the individual may not serve more than two consecutive 4-year terms.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Vacancy.</text> <paragraph num="(1)"> <text>If a vacancy occurs, the Board shall appoint a new member to serve.</text> </paragraph> <paragraph num="(2)"> <text>The successor member shall only serve for the remainder of the term, unless reappointed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Officers. From among its members, the Committee shall elect a Chair and a Vice Chair, annually.</text> </paragraph> <paragraph num="E."> <text>Quorum.</text> <paragraph num="(1)"> <text>A majority of the members then serving on the Committee is a quorum.</text> </paragraph> <paragraph num="(2)"> <text>Business may not be conducted at a Committee meeting unless there is a quorum.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Develop and make recommendations to the Board in the following areas:</text> <paragraph num="(a)"> <text>Regulations governing the practice of behavior analysis;</text> </paragraph> <paragraph num="(b)"> <text>Code of ethics requirements for the practice of behavior analysis;</text> </paragraph> <paragraph num="(c)"> <text>Requirements for licensure as a behavior analyst, including:</text> <paragraph num="(i)"> <text>Criteria for educational and clinical training of licensed behavior analysts; and</text> </paragraph> <paragraph num="(ii)"> <text>Criteria for a professional competency examination and testing of applicants for licensure to practice behavior analysis; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Continuing education requirements for license renewal;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Investigate allegations of violations of this chapter and these regulations and make recommendations to the Board regarding disposition of such allegations;</text> </paragraph> <paragraph num="(3)"> <text>Report to the Board as required; and</text> </paragraph> <paragraph num="(4)"> <text>Keep a record of its proceedings.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Qualifications."> <paragraph num="A."> <text>To qualify for licensure as a licensed behavior analyst, an individual shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be at least 18 years of age;</text> </paragraph> <paragraph num="(3)"> <text>Have a current certification as a board-certified behavior analyst or board-certified behavior analyst - doctoral verified by the Board with the Behavior Analyst Certification Board or its successor organization;</text> </paragraph> <paragraph num="(4)"> <text>Have received a master’s degree or higher from a behavior analysis educational course sequence that is approved by the Behavior Analyst Certification Board or a successor organization; and</text> </paragraph> <paragraph num="(5)"> <text>Demonstrate oral and written competency in English as required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall waive the educational requirements in §A(4) of this regulation if an individual was certified by the Behavior Analyst Certification Board on or before December 31, 2014 and is in good standing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application Procedure."> <text>To apply for a license, an individual shall submit:</text> <paragraph num="A."> <text>A completed application form to the Board on a form that the Board requires and that is provided by the Committee;</text> </paragraph> <paragraph num="B."> <text>To a criminal history records check in accordance with Health Occupations Article, §17–501.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>The following documentation:</text> <paragraph num="(1)"> <text>An official transcript, demonstrating that the applicant has met the minimum degree requirement of the Behavior Analyst Certification Board, or its successor, at the time of certification; and</text> </paragraph> <paragraph num="(2)"> <text>A copy of the applicant’s Behavior Analyst Certification Board certificate, demonstrating that the applicant is currently certified in good standing as a board-certified behavior analyst by the Behavior Analyst Certification Board, or its successor.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Renewal."> <paragraph num="A."> <text>An individual who has been licensed by the Board as a behavior analyst may renew the license every 2 years on the date specified by the Board by:</text> <paragraph num="(1)"> <text>Completing a renewal application on a form supplied by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Submitting evidence of a current certification with the Behavior Analyst Certification Board;</text> </paragraph> <paragraph num="(3)"> <text>Having current certification verified with the Behavior Analyst Certification Board;</text> </paragraph> <paragraph num="(4)"> <text>Submitting to a criminal history records check in accordance with Health Occupations Article, §17–501.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(5)"> <text>Submitting satisfactory evidence of compliance with any continuing education requirements established by the Board under Health Occupations Article, §17–6A–15(d), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed behavior analyst who has not renewed his or her license or whose license has not been placed on inactive status by the Board may not practice behavior analysis.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Continuing Education."> <paragraph num="A."> <text>A licensed behavior analyst shall complete continuing education units in accordance with the requirements of the Behavior Analyst Certification Board or its successor organization.</text> </paragraph> <paragraph num="B."> <text>A licensed behavior analyst shall document completion of continuing education requirements and retain this documentation for the succeeding 4 years for possible inspection by the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place a license on inactive status if the licensed behavior analyst submits to the Board a completed application on a form required by the Board and provided by the Committee.</text> </paragraph> <paragraph num="B."> <text>A licensed behavior analyst whose license is inactive may not practice behavior analysis until the license has been reactivated in accordance with Regulation .09 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A licensed behavior analyst whose license is inactive shall renew the inactive status every year before it expires by completing the form required by the Board and provided by the Committee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reactivation."> <paragraph num="A."> <text>A license on inactive status may be reactivated by the Board by:</text> <paragraph num="(1)"> <text>Complying with the requirements for renewal that exist at the time the license changes from inactive to active status;</text> </paragraph> <paragraph num="(2)"> <text>Meeting any continuing education requirements established by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Verifying active and current certification with the Behavior Analyst Certification Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may reject an application for reactivation if the licensed behavior analyst is found to have violated any provision of Health Occupations Article, Title 17, Subtitle 6A, Annotated Code of Maryland or this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate the license of a behavior analyst who has not been put on inactive status and who has failed to renew the license for any reason if the behavior analyst:</text> <paragraph num="(1)"> <text>Meets the requirements set forth in Regulation .09 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Applies to the Board for reinstatement of the license within 5 years after the license expires.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may not reinstate the license of a behavior analyst who fails to apply for reinstatement of the license within 5 years after the license expires.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding the provisions of §B of this regulation, a behavior analyst may become licensed by meeting the current requirements for obtaining a new license under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Practice Responsibilities."> <paragraph num="A."> <text>Except where there is a consultative agreement, the licensed behavior analyst is ultimately responsible for the design and implementation of behavior analytic services that are in the best interest of the client, under the licensed behavior analyst’s supervision.</text> </paragraph> <paragraph num="B."> <text>Behavior analysis involves the design, implementation, and evaluation of systematic instructional and environmental modifications to produce socially significant improvements in human behavior.</text> </paragraph> <paragraph num="C."> <text>The responsibilities of a licensed behavior analyst are as follows:</text> <paragraph num="(1)"> <text>Objective measurement and description of specific levels of client behavior at baseline and throughout treatment;</text> </paragraph> <paragraph num="(2)"> <text>An emphasis on understanding the current function or functions and future importance of behaviors targeted for treatment;</text> </paragraph> <paragraph num="(3)"> <text>Efforts to design, establish, and manage treatment environments in order to minimize problem behaviors and maximize progress on treatment targets;</text> </paragraph> <paragraph num="(4)"> <text>Use of a carefully constructed, individualized, and detailed behavior analytic treatment plan that:</text> <paragraph num="(a)"> <text>Utilizes reinforcement and other scientifically validated behavior analytic procedures as opposed to procedures that lack scientific evidence of effectiveness;</text> </paragraph> <paragraph num="(b)"> <text>Is designed to establish small units of behavior and build toward larger, clinically important changes in behavior that result in improved client health and functioning;</text> </paragraph> <paragraph num="(c)"> <text>Includes ongoing, frequent, direct observation and objective measurement of treatment targets and analysis of the resulting data in order to adjust treatment procedures to maximize client progress; and</text> </paragraph> <paragraph num="(d)"> <text>Is implemented repeatedly, frequently, and consistently across multiple environments by the licensed behavior analysts’ supervisees, and the client’s caregivers who are trained and supervised by the licensed behavior analyst to implement specified components of the treatment plan; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Determination and supervision of tasks to be performed by a supervisee based on the supervisee’s training, experience, and competence, in accordance with the responsibilities for supervision described in Regulation .13 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Delivery of Service Model."> <paragraph num="A."> <text>The provision of behavior analytic services may take one of three forms:</text> <paragraph num="(1)"> <text>A tiered-service delivery model;</text> </paragraph> <paragraph num="(2)"> <text>A direct service model; or</text> </paragraph> <paragraph num="(3)"> <text>A consultative model.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Unless a consultation agreement described in §E of this regulation exists, a licensed behavior analyst shall be ultimately responsible for the design and implementation of behavior analytic services that are in the best interest of the client, under the licensed behavior analyst’s supervision.</text> </paragraph> <paragraph num="C."> <text>Tiered Service Delivery Model.</text> <paragraph num="(1)"> <text>A licensed behavior analyst may utilize the services of supervisees to deliver behavior analysis services to clients, provided the licensed behavior analyst does so in accordance with this regulation and requirements set by the Behavior Analyst Certification Board.</text> </paragraph> <paragraph num="(2)"> <text>Under a tiered delivery service model:</text> <paragraph num="(a)"> <text>A licensed behavior analyst and a supervisee shall comply with the supervision responsibilities specified in Regulation .13 of this chapter and requirements set by the Behavior Analyst Certification Board;</text> </paragraph> <paragraph num="(b)"> <text>A licensed behavior analyst shall be responsible for all aspects of clinical direction, supervision, and case management, including activities of supervisees;</text> </paragraph> <paragraph num="(c)"> <text>A supervisee shall deliver assessment and treatment protocols as directed by and under the close and ongoing supervision of a licensed behavior analyst; and</text> </paragraph> <paragraph num="(d)"> <text>The licensed behavior analyst may delegate responsibilities to supervisees only if, in the judgment of the licensed behavior analyst:</text> <paragraph num="(i)"> <text>The task or procedures can be properly and safely performed by the supervisee;</text> </paragraph> <paragraph num="(ii)"> <text>Delegation does not jeopardize the health or safety of the client; and</text> </paragraph> <paragraph num="(iii)"> <text>The delegation is in accordance with the current supervision requirements of the Behavior Analyst Certification Board or successor organization.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Direct Delivery Service Model. Under a direct service delivery model, a licensed behavior analyst shall be responsible for all aspects of case management and implementation of assessment and treatment protocols.</text> </paragraph> <paragraph num="E."> <text>Consultation Agreement. Under a consultation agreement, a licensed behavior analyst:</text> <paragraph num="(1)"> <text>Shall enter into a contract with the individual or entity for whom the licensed behavior analyst will be consulting that defines:</text> <paragraph num="(a)"> <text>The frequency of the consultation;</text> </paragraph> <paragraph num="(b)"> <text>The location of the consultation; and</text> </paragraph> <paragraph num="(c)"> <text>The expectations of both parties to the contract;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Shall act principally in the best interest of the individual or entity for which the licensed behavior analyst will be consulting, with appropriate consent, subject to other relevant considerations, including applicable law and contractual obligations;</text> </paragraph> <paragraph num="(3)"> <text>When indicated and professionally appropriate, shall cooperate with other professionals in a manner that is consistent with the philosophical assumptions and principles of behavior analysis, to effectively and appropriately serve their clients; and</text> </paragraph> <paragraph num="(4)"> <text>May be held responsible for the treatment of a client for whom a behavior analytic treatment plan was recommended.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Telehealth."> <paragraph num="A."> <text>Licensure. Subject to the provisions of Health Occupations Article, Title 17, Subtitle 6A, Annotated Code of Maryland, in order to practice telehealth a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a client located in the State.</text> </paragraph> <paragraph num="B."> <text>Standards of Practice.</text> <paragraph num="(1)"> <text>Before providing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(a)"> <text>Verify the identification of the client through the use of:</text> <paragraph num="(i)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(ii)"> <text>An insurance, Medicaid, or Medicare card; or</text> </paragraph> <paragraph num="(iii)"> <text>Documentation of the client’s date of birth and home address;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For an initial client-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Maryland license number; and</text> </paragraph> <paragraph num="(iii)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Obtain oral or written informed consent from a client or a client’s parent or guardian if State law requires the consent of a parent or guardian, including informing clients of potential risks and benefits of telehealth services to be performed;</text> </paragraph> <paragraph num="(d)"> <text>Securely collect and transmit a client’s clinical data and self-reported medical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(e)"> <text>Notify clients in the event of a data breach;</text> </paragraph> <paragraph num="(f)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality and complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(g)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(a)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure;</text> </paragraph> <paragraph num="(b)"> <text>Confirm whether the client is in Maryland and identify the client’s specific location; and</text> </paragraph> <paragraph num="(c)"> <text>Identify all individuals present at each location and confirm they are permitted to hear the client’s health information.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person sessions.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Client Evaluation.</text> <paragraph num="(1)"> <text>A telehealth practitioner shall:</text> <paragraph num="(a)"> <text>Perform a synchronous or asynchronous client evaluation that is appropriate for the client and the condition with which the client presents before providing services through telehealth; and</text> </paragraph> <paragraph num="(b)"> <text>If clinically appropriate for the client, provide or refer a client to:</text> <paragraph num="(i)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(ii)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A telehealth practitioner may not treat a client based solely on an online questionnaire.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Telehealth Practitioner Discipline.</text> <paragraph num="(1)"> <text>The Board shall use the same standards in evaluating and investigating a complaint and disciplining a telehealth practitioner who practices telehealth as it would use for a telehealth practitioner who does not use telehealth technology.</text> </paragraph> <paragraph num="(2)"> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Supervision."> <paragraph num="A."> <text>A licensee shall:</text> <paragraph num="(1)"> <text>Comply with the Behavior Analyst Certification Board requirements regarding supervision of supervisees; and</text> </paragraph> <paragraph num="(2)"> <text>Use appropriate clinical judgment in determining when and how often to conduct supervision.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision Process.</text> <paragraph num="(1)"> <text>The supervision shall occur for the duration of clinical service provision (e.g., beginning with assessment and through case closure).</text> </paragraph> <paragraph num="(2)"> <text>Supervision activities may involve direct contact with the client or activities related to case management, at the discretion of the licensed behavior analyst providing the supervision and as in accordance with the requirements set by the Behavior Analyst Certification Board.</text> </paragraph> <paragraph num="(3)"> <text>The licensed behavior analyst shall be ultimately responsible and accountable for the design and implementation of behavior analytic services that are in the best interest of the client and outcomes under her or his clinical supervision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless a consultation agreement exists, a licensed behavior analyst shall be ultimately responsible for the design and implementation of behavior analytic services that are in the best interest of the client, under the licensed behavior analyst’s supervision.</text> </paragraph> <paragraph num="D."> <text>Delegation shall only be made if, in the judgment of the licensed behavior analyst:</text> <paragraph num="(1)"> <text>The task or procedures can be properly and safely performed by an appropriately trained supervisee; and</text> </paragraph> <paragraph num="(2)"> <text>The delegation does not jeopardize the health or safety of the client.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Supervision activities by the licensed behavior analyst may include, but not be limited to:</text> <paragraph num="(1)"> <text>Direct training of supervisees in implementation of behavior analytic assessment or intervention procedures;</text> </paragraph> <paragraph num="(2)"> <text>Conducting real-time, live, and person-to-person observation of the supervisee implementing behavior analytic assessment and intervention procedures with clients in natural environments or training others to implement them, with feedback from the supervisor;</text> </paragraph> <paragraph num="(3)"> <text>Conducting one-to-one real-time, live, and person-to-person interactions between supervisor and supervisee to review and discuss:</text> <paragraph num="(a)"> <text>Assessment and treatment plans and procedures;</text> </paragraph> <paragraph num="(b)"> <text>Client assessment and progress data and reports;</text> </paragraph> <paragraph num="(c)"> <text>Published research;</text> </paragraph> <paragraph num="(d)"> <text>Ethical and professional standards and guidelines;</text> </paragraph> <paragraph num="(e)"> <text>Professional development needs and opportunities; and</text> </paragraph> <paragraph num="(f)"> <text>Relevant laws, regulations, and policies; or</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Conducting real-time, live, and person-to-person interactions between a supervisor and a group of supervisees to review and discuss:</text> <paragraph num="(a)"> <text>Assessment and treatment plans and procedures;</text> </paragraph> <paragraph num="(b)"> <text>Client assessment and progress data and reports;</text> </paragraph> <paragraph num="(c)"> <text>Published research;</text> </paragraph> <paragraph num="(d)"> <text>Ethical and professional standards and guidelines;</text> </paragraph> <paragraph num="(e)"> <text>Professional development needs and opportunities; and</text> </paragraph> <paragraph num="(f)"> <text>Relevant laws, regulations, and policies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>The frequency and nature of supervision interactions are determined by the individualized assessment or treatment plans of the clients served by the licensed behavior analyst and the supervisees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Code of Ethics."> <paragraph num="A."> <text>A licensed behavior analyst shall comply with the current professional disciplinary and ethical code established by the Behavior Analyst Certification Board or its successor organization.</text> </paragraph> <paragraph num="B."> <text>Familiarity with revisions to the Behavior Analyst Certification Board’s professional disciplinary and ethical code is the responsibility of the licensed behavior analyst.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Prohibited Conduct."> <text>Subject to the hearing provisions of Health Occupations Article, §17–6A–21, Annotated Code of Maryland, the Board may deny a license to any applicant, reprimand any licensed behavior analyst, place any licensed behavior analyst on probation, or suspend or revoke a license if the applicant or licensed behavior analyst:</text> <paragraph num="A."> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensed behavior analyst or for another;</text> </paragraph> <paragraph num="B."> <text>Fraudulently or deceptively uses a license;</text> </paragraph> <paragraph num="C."> <text>Is convicted of or pleads guilty or nolo contendere to a felony or a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="D."> <text>Aids or abets an unauthorized person in practicing behavior analysis or representing oneself to be a behavior analyst;</text> </paragraph> <paragraph num="E."> <text>Practices behavior analysis fraudulently or deceitfully;</text> </paragraph> <paragraph num="F."> <text>Violates the code of ethics adopted by the Board under Health Occupations Article, §17–6A–03, Annotated Code of Maryland;</text> </paragraph> <paragraph num="G."> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="H."> <text>Submits a false statement to collect a fee;</text> </paragraph> <paragraph num="I."> <text>Willfully makes or files a false report or record in the practice of behavior analysis;</text> </paragraph> <paragraph num="J."> <text>Is disciplined by a licensing or disciplinary authority of any state or country or convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the United States Veterans Administration for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </paragraph> <paragraph num="K."> <text>Violates any provision of:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Subtitle 6A, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>This chapter;</text> </paragraph> </paragraph> <paragraph num="L."> <text>Uses or promotes or causes the use of any misleading, deceiving, or untruthful advertising matter, promotional literature, or testimonial;</text> </paragraph> <paragraph num="M."> <text>Is professionally, physically, or mentally incompetent;</text> </paragraph> <paragraph num="N."> <text>Promotes the sale of devices, appliances, or goods to a patient so as to exploit the patient for financial gain;</text> </paragraph> <paragraph num="O."> <text>Behaves immorally in the practice of behavior analysis;</text> </paragraph> <paragraph num="P."> <text>Commits an act of unprofessional conduct in the practice of behavior analysis;</text> </paragraph> <paragraph num="Q."> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensed behavior analyst is licensed and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="R."> <text>Fails to cooperate with a lawful investigation conducted by the Board;</text> </paragraph> <paragraph num="S."> <text>Commits an act that is inconsistent with generally accepted professional standards in the practice of behavior analysis;</text> </paragraph> <paragraph num="T."> <text>Fails to submit to a criminal history records check in accordance with Health Occupations Article, §17–501.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="U."> <text>Habitually is intoxicated;</text> </paragraph> <paragraph num="V."> <text>Provides professional services while under the influence of alcohol or while using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5–101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; or</text> </paragraph> <paragraph num="W."> <text>Knowingly fails to report suspected child abuse in violation of Family Law Article, §5–704, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Investigations, Hearings, and Appeals."> <paragraph num="A."> <text>Complaints alleging prohibited conduct shall be referred to the Committee to be investigated and reported to the Board according to the Board’s procedures.</text> </paragraph> <paragraph num="B."> <text>A hearing on charges issued under Regulation .15 of this chapter or Health Occupations Article, §17–6A–19, Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §§17–511 and 17–6A–21, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Committee shall follow the hearing procedures in accordance with the hearing provisions of Health Occupations Article, §§17–511 and 17–6A–21, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §17–6A–22, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Fines and Penalties."> <paragraph num="A."> <text>An individual who violates any provision of Health Occupations Article, Title 17, Subtitle 6A, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $10,000, or imprisonment not exceeding 1 year, or both.</text> </paragraph> <paragraph num="B."> <text>The Board may impose a civil fine of not more than $50,000 on an individual who violates any provision of Health Occupations Article, §17–6A–27, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>The Board shall deposit a penalty collected under §B of this regulation into the State General Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Sanctioning Guidelines."> <paragraph num="A."> <text>If, after a hearing or an opportunity for a hearing under Health Occupations Article, §17–511, Annotated Code of Maryland, the Board finds that there are grounds for discipline under Health Occupations Article, §17–6A–19, Annotated Code of Maryland, the Board may place any licensee or certificate holder on probation, reprimand any licensee or certificate holder, or suspend or revoke a license or certificate.</text> </paragraph> <paragraph num="B."> <text>In addition to placing the licensee or certificate holder on probation, reprimanding the licensee or certificate holder, or suspending or revoking the license or certificate, the Board may impose a penalty as set forth in this regulation.</text> </paragraph> <paragraph num="C."> <text>General Application of Sanctioning Guidelines. Except as provided in §J of this regulation, for violations of the Maryland Behavior Analysts Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines or more severe than the maximum listed in the guidelines for each offense.</text> </paragraph> <paragraph num="D."> <text>Ranking of Sanctions.</text> <paragraph num="(1)"> <text>For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Probation;</text> </paragraph> <paragraph num="(c)"> <text>Suspension; and</text> </paragraph> <paragraph num="(d)"> <text>Revocation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation.</text> </paragraph> <paragraph num="(3)"> <text>A stayed suspension not meeting the criteria of §D(2) of this regulation is ranked as a reprimand.</text> </paragraph> <paragraph num="(4)"> <text>A penalty listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction.</text> </paragraph> <paragraph num="(5)"> <text>The addition of a penalty does not change the ranking of the severity of the sanction.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may impose more than one sanction provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted.</text> </paragraph> <paragraph num="F."> <text>Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction.</text> </paragraph> <paragraph num="G."> <text>If a licensee is found in violation of more than one ground for discipline as enumerated in this regulation, the sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction and the Board may impose concurrent sanctions based on other grounds violated.</text> </paragraph> <paragraph num="H."> <text>Notwithstanding the guidelines set forth in this regulation, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or to a consent order with terms, sanction, and penalty agreed to by the Board and the licensee.</text> </paragraph> <paragraph num="I."> <text>If the Board imposes a sanction that departs from the sanctioning guidelines set forth in this regulation, the Board shall state its reasons for doing so in its final decision and order.</text> </paragraph> <paragraph num="J."> <text>Aggravating and Mitigating Factors.</text> <paragraph num="(1)"> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines.</text> </paragraph> <paragraph num="(2)"> <text>Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors.</text> </paragraph> <paragraph num="(3)"> <text>A departure from the guidelines set forth in this chapter is not a ground for any hearing or appeal of a Board action.</text> </paragraph> <paragraph num="(4)"> <text>The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter:</text> <paragraph num="(a)"> <text>The absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The offender self-reported the violation to the Board;</text> </paragraph> <paragraph num="(c)"> <text>The offender’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings;</text> </paragraph> <paragraph num="(d)"> <text>The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender made timely good-faith efforts to make restitution or to rectify the consequences of the misconduct;</text> </paragraph> <paragraph num="(f)"> <text>The offender has been rehabilitated or exhibits rehabilitative potential;</text> </paragraph> <paragraph num="(g)"> <text>The absence of premeditation to commit the misconduct;</text> </paragraph> <paragraph num="(h)"> <text>The absence of potential harm to patients or the public or other adverse impact; or</text> </paragraph> <paragraph num="(i)"> <text>The offender’s conduct was an isolated incident and is not likely to recur.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Aggravating factors may include, but are not limited to, the following:</text> <paragraph num="(a)"> <text>The offender has a previous criminal or administrative disciplinary history;</text> </paragraph> <paragraph num="(b)"> <text>The violation was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>The violation had the potential for, or caused, serious patient or public harm;</text> </paragraph> <paragraph num="(d)"> <text>The violation was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>The offender was motivated to perform the violation for financial gain;</text> </paragraph> <paragraph num="(f)"> <text>The vulnerability of the clients;</text> </paragraph> <paragraph num="(g)"> <text>The offender lacked insight into the wrongfulness of the conduct;</text> </paragraph> <paragraph num="(h)"> <text>The offender committed the violation under the guise of treatment;</text> </paragraph> <paragraph num="(i)"> <text>The offender attempted to hide the error or misconduct from patients or others;</text> </paragraph> <paragraph num="(j)"> <text>The offender did not cooperate with the investigation; or</text> </paragraph> <paragraph num="(k)"> <text>Previous attempts at rehabilitation of the offender were unsuccessful.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>Payment of a Penalty.</text> <paragraph num="(1)"> <text>A licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise.</text> </paragraph> <paragraph num="(2)"> <text>Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §17-512, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this regulation.</text> </paragraph> <paragraph num="(3)"> <text>If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this regulation, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="(4)"> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="(5)"> <text>The Board shall pay all monies collected under this regulation into the State's General Fund.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §1-606, 1-1001—1-1006, and Title 17, Subtitle 6A, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 22, 2017 (44:10 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 18, 2023 (50:18 Md. R. 799)</annotation> <annotation type="History" subtype="Administrative History">New Regulation .13 adopted effective September 18, 2023 (50:18 Md. R. 799)</annotation> <annotation type="History" subtype="Administrative History">Regulations .13—18 recodified to be Regulations .14—.19 effective September 18, 2023 (50:18 Md. R. 799)</annotation> </annotations> </chapter> <chapter num="17" heading="Art Therapists"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter:</text> <paragraph num="(1)"> <text>Establishes the requirements for an individual to practice professional art therapy;</text> </paragraph> <paragraph num="(2)"> <text>Establishes standards of supervision and the responsibilities of supervisors and supervisees in the practice of clinical professional art therapy;</text> </paragraph> <paragraph num="(3)"> <text>Applies to licensees who:</text> <paragraph num="(a)"> <text>Practice clinical professional art therapy; and</text> </paragraph> <paragraph num="(b)"> <text>Provide supervision for licensed graduate professional art therapists;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Applies to licensed graduate professional art therapists who are in the process of obtaining the supervised clinical experience required by Health Occupations Article, §17-304.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(5)"> <text>Does not apply to personnel or management practices associated with contractual relationships or employment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On or after December 31, 2018, an approved art therapy supervisor shall follow the requirements set forth in Regulations .06—.08 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means a college or university that is:</text> <paragraph num="(a)"> <text>Accredited through a recognized body endorsed by the U.S. Department of Education; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Applicant” means an individual applying for licensure as a clinical or graduate professional art therapist.</text> </paragraph> <paragraph num="(3)"> <text>“Approved art therapy supervisor” means:</text> <paragraph num="(a)"> <text>An Art Therapy Credentials Board Certified Supervisor;</text> </paragraph> <paragraph num="(b)"> <text>An Art Therapy Credentials Board Registered Art Therapist or Board Certified Art Therapist;</text> </paragraph> <paragraph num="(c)"> <text>A licensed clinical professional art therapist; or</text> </paragraph> <paragraph num="(d)"> <text>Another mental health care provider approved by the Board and licensed under the Health Occupations Article, Title 17, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Equivalent” means a degree in a program of studies determined by the Board to have:</text> <paragraph num="(a)"> <text>Substantial art therapy emphasis in the subject matter; and</text> </paragraph> <paragraph num="(b)"> <text>The extent of training required for the specified level of licensure.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Face-to-Face.</text> <paragraph num="(a)"> <text>“Face-to-face” means in the physical presence of the individuals involved in the supervisory relationship during either individual or group supervision or using video conferencing which allows individuals to hear and see each other in actual points of time.</text> </paragraph> <paragraph num="(b)"> <text>“Face-to-face” does not include:</text> <paragraph num="(i)"> <text>Telephone supervision; or</text> </paragraph> <paragraph num="(ii)"> <text>Internet communication that does not involve actual or real time video conferencing, such as instant messaging services, emails, texting, and social networking sites.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Group supervision” means the provision of face-to-face supervision to more than one individual at a time.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed graduate professional art therapist” means an individual approved by the Board to practice graduate professional art therapy under the supervision of an approved supervisor while fulfilling the supervised clinical experience for licensure under:</text> <paragraph num="(a)"> <text>Health Occupations Article, §§17-304.1 and 17-309, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Regulation .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Licensed mental health care provider” means:</text> <paragraph num="(a)"> <text>A licensed clinical professional art therapist;</text> </paragraph> <paragraph num="(b)"> <text>Another mental health care provider approved by the Board and licensed under Health Occupations Article, Title 17, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>A licensed mental health care provider from a state, territory, or jurisdiction that authorizes the application of equivalent art therapy principles and methods as set forth in Health Occupations Article, §17-308, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Practice” means to engage professionally and for compensation in art therapy and appraisal activities by providing services for individuals, couples, families and groups involving:</text> <paragraph num="(a)"> <text>The application of therapy principles; and</text> </paragraph> <paragraph num="(b)"> <text>Methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Relative” means:</text> <paragraph num="(a)"> <text>Spouse, or domestic partner;</text> </paragraph> <paragraph num="(b)"> <text>Parent, stepparent or legal guardian;</text> </paragraph> <paragraph num="(c)"> <text>Sibling or stepsibling;</text> </paragraph> <paragraph num="(d)"> <text>Child, stepchild, foster child, or ward;</text> </paragraph> <paragraph num="(e)"> <text>Mother-in-law or father-in-law;</text> </paragraph> <paragraph num="(f)"> <text>Son-in-law or daughter-in-law;</text> </paragraph> <paragraph num="(g)"> <text>Grandparent or grandchild;</text> </paragraph> <paragraph num="(h)"> <text>Aunt or uncle; or</text> </paragraph> <paragraph num="(i)"> <text>Cousin.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Supervised clinical experience in professional art therapy” means therapy services conducted under the supervision of an approved art therapy supervisor that includes:</text> <paragraph num="(a)"> <text>Monitoring the performance of a supervisee; and</text> </paragraph> <paragraph num="(b)"> <text>Providing, with respect to clinical skill and competencies:</text> <paragraph num="(i)"> <text>Documented and direct consultation;</text> </paragraph> <paragraph num="(ii)"> <text>Guidance; and</text> </paragraph> <paragraph num="(iii)"> <text>Instruction.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Supervision training” means a course or program designed to provide information regarding the supervision process utilized by:</text> <paragraph num="(a)"> <text>Licensed clinical professional art therapists; or</text> </paragraph> <paragraph num="(b)"> <text>Licensed mental health providers.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensed Clinical Professional Art Therapist."> <paragraph num="A."> <text>To qualify for licensure as a clinical professional art therapist, an applicant shall have:</text> <paragraph num="(1)"> <text>Completed one of the following from an accredited educational institution:</text> <paragraph num="(a)"> <text>A master’s degree in an art therapy program approved by the Board with:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>90 graduate quarter credit hours;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A doctoral degree in an art therapy program approved by the Board with:</text> <paragraph num="(i)"> <text>A minimum of 90 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>135 graduate quarter credit hours; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A graduate level degree which:</text> <paragraph num="(i)"> <text>Includes the coursework listed in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Is approved by the Board;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed a minimum of 3 graduate semester credit hours in each of the following course content areas:</text> <paragraph num="(a)"> <text>Human growth and personality development;</text> </paragraph> <paragraph num="(b)"> <text>Social and cultural foundations of counseling;</text> </paragraph> <paragraph num="(c)"> <text>Theories of art therapy;</text> </paragraph> <paragraph num="(d)"> <text>Art therapy techniques:</text> </paragraph> <paragraph num="(e)"> <text>Group dynamics, processing, and counseling;</text> </paragraph> <paragraph num="(f)"> <text>Lifestyle and career development;</text> </paragraph> <paragraph num="(g)"> <text>Appraisal;</text> </paragraph> <paragraph num="(h)"> <text>Research and evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Professional, legal, and ethical responsibilities;</text> </paragraph> <paragraph num="(j)"> <text>Marriage and family therapy;</text> </paragraph> <paragraph num="(k)"> <text>Supervised field experience that includes:</text> <paragraph num="(i)"> <text>A supervised clinical internship, externship, field experience, or practicum placement; and</text> </paragraph> <paragraph num="(ii)"> <text>Direct client contact in art therapy with a minimum of 125 hours of face-to-face client therapy;</text> </paragraph> </paragraph> <paragraph num="(l)"> <text>Alcohol and drug counseling;</text> </paragraph> <paragraph num="(m)"> <text>Psychopathology; and</text> </paragraph> <paragraph num="(n)"> <text>Diagnosis and treatment of mental and emotional disorders;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For a master’s level applicant, completed supervised clinical experience in professional art therapy obtained under the supervision of an approved art therapy supervisor of not less than 3 years with a minimum of 3,000 hours, of which:</text> <paragraph num="(a)"> <text>1,500 hours shall be face-to-face client contact hours, including 100 face-to-face clinical supervision hours obtained after the awarding of a master’s degree, of which:</text> <paragraph num="(i)"> <text>At least 50 hours shall be face-to-face individual clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>50 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A maximum of 1 year and 1,000 hours of clinical experience may be acquired before the awarding of the master's degree; and</text> </paragraph> <paragraph num="(c)"> <text>Not less than 2 years and 2,000 hours shall be acquired after the master's degree has been awarded;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For a doctoral level applicant, completed supervised clinical experience in professional art therapy obtained under the supervision of an approved art therapy supervisor of not less than 2 years with a minimum of 2,000 hours, of which:</text> <paragraph num="(a)"> <text>1,000 hours shall be face-to-face client contact hours, including 50 face-to-face clinical supervision hours obtained after the awarding of a doctoral degree, of which:</text> <paragraph num="(i)"> <text>At least 25 hours shall be face-to-face individual clinical supervision; and</text> </paragraph> <paragraph num="(ii)"> <text>25 hours may be face-to-face group clinical supervision;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A maximum of 1 year and 1,000 hours of clinical experience may be acquired before the awarding of the doctoral degree; and</text> </paragraph> <paragraph num="(c)"> <text>Not less than 1 year and 1,000 hours shall be acquired after the doctoral degree has been awarded;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>Submitted a completed Board-approved application;</text> </paragraph> <paragraph num="(7)"> <text>Provided an official transcript from the educational institution which awarded the master’s or doctoral degree;</text> </paragraph> <paragraph num="(8)"> <text>Paid all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(9)"> <text>Submitted to a criminal background check;</text> </paragraph> <paragraph num="(10)"> <text>Good moral character; and</text> </paragraph> <paragraph num="(11)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure may retake the exam.</text> </paragraph> <paragraph num="C."> <text>The Board shall act upon applications within a 6-month period as follows:</text> <paragraph num="(1)"> <text>Within 90 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board or the Board’s designee shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of a notice, the applicant shall correct the deficiency within 90 days, or another period specified in the notice; and</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application shall lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the required non-refundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Renewal.</text> <paragraph num="(1)"> <text>To renew a clinical professional art therapist license, the applicant shall:</text> <paragraph num="(a)"> <text>Submit a completed Board-approved application;</text> </paragraph> <paragraph num="(b)"> <text>Pay the required application fee set forth in COMAR 10.58.02; and</text> </paragraph> <paragraph num="(c)"> <text>Attest to completion of continuing education activities as specified in COMAR 10.58.05.05 and .06.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed clinical professional art therapist shall comply with the renewal requirements as provided in Health Occupations Article, §17–504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>An individual who fails to renew licensure is not authorized to and may not practice clinical professional art therapy.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>Within 5 calendar years after the certificate renewal date, the Board may reinstate the license of a licensed clinical professional art therapist otherwise entitled to reinstatement under Health Occupations Article, §17-505(b), Annotated Code of Maryland, whose license was not renewed for any reason, if the licensee:</text> <paragraph num="(a)"> <text>Completes within that 5-year period the minimum of 20 CEUs required for each year; and</text> </paragraph> <paragraph num="(b)"> <text>Pays the reinstatement fee set by the Board in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>CEUs which are acquired in order to reinstate under COMAR 10.58.05.05 and.06 may be credited only once and may not be credited for any future renewals.</text> </paragraph> <paragraph num="(3)"> <text>For any licensed clinical professional art therapist whose license has expired more than 5 calendar years before the request for reinstatement, a new application for licensure shall be completed and the current licensure requirements shall be met.</text> </paragraph> <paragraph num="(4)"> <text>An individual who fails to reinstate licensure is not authorized to and may not practice clinical professional art therapy.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Inactive Status.</text> <paragraph num="(1)"> <text>In accordance with Health Occupations Article, §17-505, Annotated Code of Maryland, a request to transfer a license to inactive status shall be granted upon receipt of the:</text> <paragraph num="(a)"> <text>Completed Board-approved application; and</text> </paragraph> <paragraph num="(b)"> <text>Payment of the required, non-refundable, annual fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual may apply for inactive status only if the individual’s license is still active at the time application for inactive status is made.</text> </paragraph> <paragraph num="(3)"> <text>An individual on inactive status is not authorized to and may not practice clinical professional art therapy.</text> </paragraph> <paragraph num="(4)"> <text>An individual on inactive status seeking to be reinstated to active status shall be required, as a condition of reinstatement, to submit proof of having completed 20 CEU’s for each year of inactive status, at least 40 of which shall have been obtained within the 2-year period immediately preceding the application for reinstatement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Licensed Graduate Professional Art Therapist."> <paragraph num="A."> <text>To qualify for licensure as a graduate professional art therapist, an applicant shall have:</text> <paragraph num="(1)"> <text>Completed one of the following from an accredited educational institution approved by the Board:</text> <paragraph num="(a)"> <text>A master’s degree in an art therapy program approved by the Board with:</text> <paragraph num="(i)"> <text>A minimum of 60 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>90 graduate quarter credit hours;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A doctoral degree in an art therapy program approved by the Board with:</text> <paragraph num="(i)"> <text>A minimum of 90 graduate semester credit hours; or</text> </paragraph> <paragraph num="(ii)"> <text>135 graduate quarter credit hours; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A graduate level degree which:</text> <paragraph num="(i)"> <text>Includes the coursework listed in §A(2) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Is approved by the Board;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Completed the graduate coursework required as set forth in Regulation .03A(2) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Achieved a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Submitted a completed Board-approved application;</text> </paragraph> <paragraph num="(5)"> <text>Provided an official transcript from the educational institution which awarded the master’s or doctoral degree;</text> </paragraph> <paragraph num="(6)"> <text>Paid all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="(7)"> <text>Submitted to a criminal background check;</text> </paragraph> <paragraph num="(8)"> <text>Good moral character; and</text> </paragraph> <paragraph num="(9)"> <text>Complied with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who fails an examination for licensure may retake the exam.</text> </paragraph> <paragraph num="C."> <text>Composition of Supervised Clinical Experience.</text> <paragraph num="(1)"> <text>A licensed graduate professional art therapist shall complete at least half of the requisite supervised clinical experience in professional art therapy hours under the supervision of a licensed clinical professional art therapist who has been approved by the Board to provide art therapy supervision.</text> </paragraph> <paragraph num="(2)"> <text>A licensed graduate professional art therapist may complete the remainder of the supervised clinical experience in professional art therapy hours under the supervision of an approved art therapy supervisor as defined in Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall act upon applications within a 6-month period as follows:</text> <paragraph num="(1)"> <text>Within 90 days after receipt of an application, the Board shall determine whether the application is complete;</text> </paragraph> <paragraph num="(2)"> <text>If the Board determines that the application is not complete, the Board or the Board’s designee shall send a notice of deficiency to the applicant;</text> </paragraph> <paragraph num="(3)"> <text>Upon receipt of a notice, the applicant shall correct the deficiency within 90 days, or other period specified in the notice; and</text> </paragraph> <paragraph num="(4)"> <text>If the applicant fails to correct the deficiency within the required period, the application shall lapse and the applicant shall be required to:</text> <paragraph num="(a)"> <text>Submit a new application; and</text> </paragraph> <paragraph num="(b)"> <text>Pay the required non-refundable fee set forth in COMAR 10.58.02.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Expiration, Renewal, and Extension.</text> <paragraph num="(1)"> <text>The graduate professional art therapist license expires 2 years after the date issued.</text> </paragraph> <paragraph num="(2)"> <text>If a licensed graduate professional art therapist is unable to accumulate the required clinical hours of supervision for licensure within 2 years, the licensee may apply for a 2-year extension before the license expires, up to a maximum of 6 years.</text> </paragraph> <paragraph num="(3)"> <text>A licensed graduate professional art therapist who has applied for and received an extension as set forth in §D(2) of this regulation, shall comply with the renewal requirements as provided in Health Occupations Article, §17–504, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>If a licensed graduate professional art therapist notifies the Board in writing, the Board may consider a license extension beyond the 6-year maximum set forth in §D(2) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensure Eligibility: Out-of-State Applicants."> <text>An applicant licensed as an art therapist or its equivalent, as established by the Board, in another state, territory, or jurisdiction is eligible for licensure if the applicant:</text> <paragraph num="A."> <text>Provides:</text> <paragraph num="(1)"> <text>A completed Board-approved application;</text> </paragraph> <paragraph num="(2)"> <text>Verification that the applicant has:</text> <paragraph num="(a)"> <text>A copy of a current license from each state, territory, or jurisdiction in which the applicant has been licensed, registered, or otherwise authorized to practice art therapy;</text> </paragraph> <paragraph num="(b)"> <text>Documentation, satisfactory to the Board, that the applicant is currently licensed in good standing to practice art therapy in another state, territory, or jurisdiction;</text> </paragraph> <paragraph num="(c)"> <text>No history of disciplinary action, past or pending, in a state, territory, or jurisdiction in which the applicant holds a license to practice art therapy; and</text> </paragraph> <paragraph num="(d)"> <text>Not committed any act or omission that would be grounds for discipline or denial of licensure under Health Occupations Article, §17-509, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An official transcript from the educational institution which awarded the master’s or doctoral degree;</text> </paragraph> <paragraph num="(4)"> <text>Verification from employers, supervisors, or colleagues after the awarding of the graduate degree, that the applicant has practiced clinical professional art therapy for:</text> <paragraph num="(a)"> <text>Not less than 2 years; and</text> </paragraph> <paragraph num="(b)"> <text>A minimum of 2,000 hours; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For an applicant with a master’s degree consisting of less than 60 graduate semester credit hours:</text> <paragraph num="(a)"> <text>Documentation, satisfactory to the Board, of not less than 2 years and minimum of 2,000 hours after the awarding of the graduate degree; and</text> </paragraph> <paragraph num="(b)"> <text>Documentation showing completion of a minimum of 3 graduate semester credit hours covering each of the following primary topics or content areas:</text> <paragraph num="(i)"> <text>Diagnosis and treatment of mental and emotional disorders;</text> </paragraph> <paragraph num="(ii)"> <text>Appraisal;</text> </paragraph> <paragraph num="(iii)"> <text>Professional, legal, and ethical responsibilities; and</text> </paragraph> <paragraph num="(iv)"> <text>Current certification from a national accrediting body approved by the Board;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Pays all applicable fees set forth in COMAR 10.58.02;</text> </paragraph> <paragraph num="C."> <text>Achieves a passing score on:</text> <paragraph num="(a)"> <text>A national certification exam approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>An examination of:</text> <paragraph num="(i)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.58;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Submits to a criminal background check;</text> </paragraph> <paragraph num="E."> <text>Is of good moral character; and</text> </paragraph> <paragraph num="F."> <text>Complies with:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>The code of ethics as set forth in COMAR 10.58.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standards for Supervision."> <paragraph num="A."> <text>A supervisor shall:</text> <paragraph num="(1)"> <text>Supervise only in those areas within the supervisor’s competence as determined by education, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>Provide supervision appropriate to the particular level of licensure being applied for or maintained;</text> </paragraph> <paragraph num="(3)"> <text>Provide supervision in the general content areas established in Health Occupations Article, §17-304.1, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.58, with special emphasis on the Code of Ethics, COMAR 10.58.03.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, the supervisor shall specifically instruct and provide guidance:</text> <paragraph num="(1)"> <text>Relating to the supervisee’s scope of practice of clinical professional art therapy under Health Occupations Article, §17-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>To supervisees in appropriate billing practices if applicable to the practice site including:</text> <paragraph num="(a)"> <text>Providing services involving the application of therapy principles and methods in the diagnosis, prevention, treatment, and amelioration of psychological problems, emotional conditions, or mental conditions of individuals, families, couples or groups, as stated in Health Occupations Article, §17-308, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Record keeping;</text> </paragraph> <paragraph num="(c)"> <text>Disclosure of fees and financial arrangements; and</text> </paragraph> <paragraph num="(d)"> <text>Appropriate maintenance and destruction of clinical and financial records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The following individuals may not provide clinical supervision for a licensed graduate professional art therapy supervisee:</text> <paragraph num="(1)"> <text>A relative;</text> </paragraph> <paragraph num="(2)"> <text>A licensed graduate professional art therapist;</text> </paragraph> <paragraph num="(3)"> <text>A licensed graduate alcohol and drug counselor;</text> </paragraph> <paragraph num="(4)"> <text>A licensed graduate professional counselor;</text> </paragraph> <paragraph num="(5)"> <text>A licensed graduate marriage and family therapist;</text> </paragraph> <paragraph num="(6)"> <text>A certified alcohol and drug counselor;</text> </paragraph> <paragraph num="(7)"> <text>An individual with whom there could be a conflict of interest, including, but not limited to:</text> <paragraph num="(a)"> <text>An employee supervising their own employer; or</text> </paragraph> <paragraph num="(b)"> <text>A student supervising their own teacher; or</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Any other graduate level health care provider licensed under Health Occupations Article, Title 17, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Supervisor Qualifications."> <paragraph num="A."> <text>Licensure. An individual providing supervision shall be approved by the Board and licensed by the Board as a</text> <paragraph num="(1)"> <text>Clinical professional art therapist;</text> </paragraph> <paragraph num="(2)"> <text>Clinical professional counselor;</text> </paragraph> <paragraph num="(3)"> <text>Clinical alcohol and drug counselor;</text> </paragraph> <paragraph num="(4)"> <text>Clinical marriage and family therapist; or</text> </paragraph> <paragraph num="(5)"> <text>Mental health care provider as defined in Regulation .02B of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Supervision Experience, Education and Training.</text> <paragraph num="(1)"> <text>A supervisor or any mental health care provider, licensed by the Board under Health Occupations Article, Title 17, Annotated Code of Maryland, who is approved by the Board and has completed 3 years of documented experience in clinical counseling or psychotherapy, shall complete by December 31, 2019:</text> <paragraph num="(a)"> <text>2 years of documented experience providing art therapy supervision;</text> </paragraph> <paragraph num="(b)"> <text>At least 3 graduate semester credit hours or 5 quarter credit hours of academic coursework in art therapy supervision;</text> </paragraph> <paragraph num="(c)"> <text>At least 3 graduate semester credit hours or 5 quarter credit hours of academic coursework in counseling supervision; or</text> </paragraph> <paragraph num="(d)"> <text>A Board-approved continuing education program that includes a minimum of 18 continuing education units (CEUs) with a trainer or trainers in:</text> <paragraph num="(i)"> <text>Counseling;</text> </paragraph> <paragraph num="(ii)"> <text>Art therapy; or</text> </paragraph> <paragraph num="(iii)"> <text>Psychotherapy supervision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>A licensed individual who applied for and was granted Board-approved supervisor status before December 31, 2019 based on 2 years of documented experience providing art therapy supervision, may continue to provide art therapy supervision after that date.</text> </paragraph> <paragraph num="(3)"> <text>After December 31, 2019, an applicant for Board-approved supervisor status shall have:</text> <paragraph num="(a)"> <text>3 years documented experience in professional art therapy as approved by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Completed the requirements of §A or B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Supervision training required by this section may be obtained in a graduate course that may include, but is not limited to:</text> <paragraph num="(a)"> <text>The role and responsibilities of the supervisor;</text> </paragraph> <paragraph num="(b)"> <text>The needs of the supervisee, supervisor, and the agency setting while maintaining a clear ethical perspective, including:</text> <paragraph num="(i)"> <text>The maintenance of appropriate boundaries; and</text> </paragraph> <paragraph num="(ii)"> <text>Making clinically appropriate diagnoses;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The role of the supervisor as gatekeeper to the profession;</text> </paragraph> <paragraph num="(d)"> <text>Methods for building effective and appropriate relationships with clients;</text> </paragraph> <paragraph num="(e)"> <text>Models for group supervision; and</text> </paragraph> <paragraph num="(f)"> <text>Models and modalities for practice intervention.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-Supervision Responsibilities of a Supervisor. In addition to meeting the requirements of this regulation, the supervisor shall:</text> <paragraph num="(1)"> <text>File the completed Board-approved licensed professional art therapy supervisor application form;</text> </paragraph> <paragraph num="(2)"> <text>Provide the supervisee with a copy of the Board’s licensed clinical professional art therapy supervisor letter; and</text> </paragraph> <paragraph num="(3)"> <text>Have an active license that is without restrictions or conditions due to disciplinary action for the 2 years preceding an application for licensed clinical professional art therapy-approved supervisor status.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Supervisor Responsibilities."> <text>A supervisor shall:</text> <paragraph num="A."> <text>Agree to and sign a Board-approved contract before initiating supervision;</text> </paragraph> <paragraph num="B."> <text>Ensure that the supervisee is practicing within the scope of the supervisee’s license;</text> </paragraph> <paragraph num="C."> <text>Determine the skill level at which the supervisee may practice;</text> </paragraph> <paragraph num="D."> <text>Focus on primary data from the supervisee’s practice;</text> </paragraph> <paragraph num="E."> <text>Maintain documentation of supervisory sessions for at least 7 years, including:</text> <paragraph num="(1)"> <text>Dates;</text> </paragraph> <paragraph num="(2)"> <text>Duration; and</text> </paragraph> <paragraph num="(3)"> <text>Focus of the supervisory sessions;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Ensure that a supervisee has read and is knowledgeable about:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 17, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>COMAR 10.58 with special emphasis on the Code of Ethics, COMAR 10.58.03;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Within a reasonable period of time before the conclusion of supervision, provide the supervisee and employer with a notice of termination to avoid or minimize any harmful effect on the supervisee’s clients or patients;</text> </paragraph> <paragraph num="H."> <text>Be responsible for the clinical professional practices of supervisees;</text> </paragraph> <paragraph num="I."> <text>Provide:</text> <paragraph num="(1)"> <text>For emergency supervision and direction to a supervisee by a Board-approved supervisor;</text> </paragraph> <paragraph num="(2)"> <text>A written evaluation of progress to the supervisee on a regular basis or as needed; and</text> </paragraph> <paragraph num="(3)"> <text>A copy of the documentation required by §E of this regulation on request by the:</text> <paragraph num="(a)"> <text>Supervisee; or</text> </paragraph> <paragraph num="(b)"> <text>Board or its authorized agent; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Comply with a Board audit of a supervisor’s compliance with regard to the supervisory requirements and responsibilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Supervisee Responsibilities."> <paragraph num="A."> <text>A supervisee shall:</text> <paragraph num="(1)"> <text>Verify that the supervisor has been approved by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Agree to and sign a Board-approved contract before initiating supervision;</text> </paragraph> <paragraph num="(3)"> <text>Attend and participate in supervision as agreed to in the supervision contract;</text> </paragraph> <paragraph num="(4)"> <text>Prepare for supervision using case materials related to the supervisee’s clinical professional art therapy practice; and</text> </paragraph> <paragraph num="(5)"> <text>Maintain documentation of supervisory sessions for at least 7 years, to be available for verification to the Board or its authorized agent, including:</text> <paragraph num="(a)"> <text>Dates;</text> </paragraph> <paragraph num="(b)"> <text>Duration; and</text> </paragraph> <paragraph num="(c)"> <text>Focus of the supervision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A supervisee may not engage in the practice of clinical professional art therapy independent of supervision.</text> </paragraph> <paragraph num="C."> <text>A supervisee shall give the client a copy of a professional disclosure statement as described in Health Occupations Article, §17-507, Annotated Code of Maryland, that:</text> <paragraph num="(1)"> <text>Clearly states the art therapy services are provided under clinical supervision; and</text> </paragraph> <paragraph num="(2)"> <text>Provides the name of the supervisor with address and contact information.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A supervisee shall obtain from the client a signed:</text> <paragraph num="(1)"> <text>Release of information; and</text> </paragraph> <paragraph num="(2)"> <text>Informed consent for treatment which indicates that the client:</text> <paragraph num="(a)"> <text>Is aware that art therapy services are being provided under clinical supervision;</text> </paragraph> <paragraph num="(b)"> <text>Consents to the recording of art therapy sessions with the knowledge that the recording may only be shared with the supervisor; and</text> </paragraph> <paragraph num="(c)"> <text>Consents to the sharing of client information between the licensed graduate professional art therapist and the named clinical supervisor.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§17-101, 17-205, 17-301, 17-304.1, 17-304.2, 17-307, 17-307.1, 17-309,17-501.1, 17-502—17-505, 17-507, and 17-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 31, 2018 (45:26 Md. R. 1246)</annotation> </annotations> </chapter> </subtitle> <subtitle num="59" heading="Catastrophic Health Emergencies"> <chapter num="01" heading="Care of Individuals Isolated or Quarantined Due to a Deadly Agent"> <regulation prefix="Regulation" num=".01" heading="Incorporation By Reference."> <text>Guideline for Isolation Precautions in Hospitals; Julia S. Garner and the Hospital Infection Control Practices Advisory Committee; (American Journal of Infection Control), which has been incorporated by reference in COMAR 10.07.02.01-1, is incorporated by reference in this chapter.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Deadly agent” means:</text> <paragraph num="(a)"> <text>Anthrax, ebola, plague, smallpox, tularemia, or other bacterial, fungal, rickettsial, or viral agent, biological toxin, or other biological agent capable of causing extensive loss of life or serious disability;</text> </paragraph> <paragraph num="(b)"> <text>Mustard gas, nerve gas, or other chemical agent capable of causing extensive loss of life or serious disability; or</text> </paragraph> <paragraph num="(c)"> <text>Radiation at levels capable of causing extensive loss of life or serious disability.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Health care facility” has the meaning stated in Health-General Article, §19-114, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Health officer” means the health officer of each of the 23 counties and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both.</text> </paragraph> <paragraph num="(5)"> <text>“Isolation” means the separation or restriction of movement of an individual who is ill and has an infectious illness or who is ill and is suspected of having an infectious illness from those who are not ill or infected for the purpose of stopping the spread of the infectious illness.</text> </paragraph> <paragraph num="(6)"> <text>“Quarantine” means the separation or restriction of movement of an individual who, though not ill, has been or may have been exposed to an infectious agent, to prevent the spread of infectious illness that may be transmitted to other individuals before illness develops or is recognized.</text> </paragraph> <paragraph num="(7)"> <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards For Isolation and Quarantine."> <paragraph num="A."> <text>As set forth in Health-General Article, §18-905, Annotated Code of Maryland, in investigating actual or potential exposures to a deadly agent, the Secretary may order isolation or quarantine of an individual or a group of individuals, including those individuals who refuse to be vaccinated, medically examined, treated, or tested.</text> </paragraph> <paragraph num="B."> <text>An individual who does not comply with an isolation or quarantine order of the Secretary is guilty of a misdemeanor and on conviction is subject to a fine and imprisonment pursuant to Health-General Article, §18-907(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>If the Secretary issues an order in compliance with Health-General Article, §18-905(b), Annotated Code of Maryland, the Secretary may order an individual into isolation or quarantine at:</text> <paragraph num="(1)"> <text>A health care facility;</text> </paragraph> <paragraph num="(2)"> <text>The individual's home; or</text> </paragraph> <paragraph num="(3)"> <text>A nonhealth care facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Place of Quarantine or Isolation other than the Individual's Home.</text> <paragraph num="(1)"> <text>If the Secretary has determined that it is necessary to issue an isolation or quarantine order for an individual to a facility other than the individual's home, the health officer, in consultation with other public health professionals, shall recommend to the Secretary a suitable place for isolation or quarantine.</text> </paragraph> <paragraph num="(2)"> <text>The health officer shall base the recommendation for a place for isolation or quarantine on the following:</text> <paragraph num="(a)"> <text>The seriousness of the disease;</text> </paragraph> <paragraph num="(b)"> <text>The route or routes of transmission of the disease;</text> </paragraph> <paragraph num="(c)"> <text>The contagiousness of the disease;</text> </paragraph> <paragraph num="(d)"> <text>Precedents in the practice of public health;</text> </paragraph> <paragraph num="(e)"> <text>The behavior, neurological development and condition, and physical condition of the individual being isolated or quarantined; and</text> </paragraph> <paragraph num="(f)"> <text>The access to needed support services at the site.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The health officer, with assistance from local emergency management services, law enforcement personnel, or both, as needed, shall arrange for and provide, if needed, transportation for an individual to be isolated or quarantined.</text> </paragraph> <paragraph num="F."> <text>The health officer, with assistance from the local law enforcement agency as needed, shall monitor an isolated or quarantined individual by phone call, home visit, or other means, to ensure that the isolated or quarantined individual stays in the designated facility at all times during the period of isolation or quarantine, except in an emergency such as fire, natural disaster, or evacuation of the area by a county, State, or federal agency for any other reason.</text> </paragraph> <paragraph num="G."> <text>If evacuation from the site occurs in an emergency, an isolated or quarantined individual shall notify the health officer immediately by a phone call or any other means possible and follow instructions given by the health officer.</text> </paragraph> <paragraph num="H."> <text>Unless not available in the community due to a general state of emergency, the health officer, the administrator of a health care facility, or an individual in charge of an isolation or quarantine facility set forth in Regulation .07B of this chapter, with assistance from staff at local health care facilities, local law enforcement agencies, local social service agencies, local county agencies, or other agencies, shall ensure that an isolation or quarantine facility has, at a minimum:</text> <paragraph num="(1)"> <text>Electricity;</text> </paragraph> <paragraph num="(2)"> <text>Hot and cold potable (fit to drink) water;</text> </paragraph> <paragraph num="(3)"> <text>Hand-washing facilities;</text> </paragraph> <paragraph num="(4)"> <text>Toilets;</text> </paragraph> <paragraph num="(5)"> <text>Heat;</text> </paragraph> <paragraph num="(6)"> <text>Telephone access; and</text> </paragraph> <paragraph num="(7)"> <text>Means for discarding trash and waste.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If an isolated or quarantined individual is in a health care facility, the administrator of the health care facility, and otherwise the health officer, with assistance from staff at local health care facilities, local law enforcement agencies, local social service agencies, local county agencies, or other agencies, shall ensure that an individual in isolation or quarantine has access to, at a minimum:</text> <paragraph num="(1)"> <text>Food;</text> </paragraph> <paragraph num="(2)"> <text>Medical supplies;</text> </paragraph> <paragraph num="(3)"> <text>Medications; and</text> </paragraph> <paragraph num="(4)"> <text>Medical care, including psychological care.</text> </paragraph> </paragraph> <paragraph num="J."> <text>To the extent feasible, the health officer shall provide information to an isolated or quarantined individual, without compromising the health of the isolated or quarantined individual or the people caring for the isolated or quarantined individual, by:</text> <paragraph num="(1)"> <text>Assessing the language needs of the isolated or quarantined individual;</text> </paragraph> <paragraph num="(2)"> <text>Translating both oral and written communications and documentation; and</text> </paragraph> <paragraph num="(3)"> <text>Monitoring to assure that the isolated or quarantined individual is not treated in a discriminatory manner.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If an isolated or quarantined individual is in a health care facility, the administrator of the health care facility, and otherwise the health officer, shall, to the extent feasible:</text> <paragraph num="(1)"> <text>Determine whether the individual has any cultural or religious beliefs that would interfere with medical care during quarantine or isolation; and</text> </paragraph> <paragraph num="(2)"> <text>Make arrangements to accommodate these beliefs, without compromising the health of:</text> <paragraph num="(a)"> <text>The isolated or quarantined individual; or</text> </paragraph> <paragraph num="(b)"> <text>The people caring for the isolated or quarantined individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>An individual in isolation or quarantine shall:</text> <paragraph num="(1)"> <text>Follow all written and verbal instructions provided by the Department and the local health department;</text> </paragraph> <paragraph num="(2)"> <text>Notify and receive approval from the local health officer in advance of relocation to a new isolation or quarantine site, except in an emergency such as fire, natural disaster, or evacuation of the area by a county, State, or federal agency for any other reason; and</text> </paragraph> <paragraph num="(3)"> <text>Notify the health officer immediately upon relocation to a new location, in the event of an emergency such as fire, natural disaster, or evacuation of the area by a county, State, or federal agency for any other reason.</text> </paragraph> </paragraph> <paragraph num="M."> <text>An individual in isolation or quarantine may not leave the isolation or quarantine site without notification of the health officer, except in an emergency such as fire, natural disaster, or evacuation of the area by a county, State, or federal agency for any other reason.</text> </paragraph> <paragraph num="N."> <text>Parent or Guardian of an Isolated or Quarantined Minor.</text> <paragraph num="(1)"> <text>If the Secretary orders a minor into isolation or quarantine, the minor's parent or guardian may accompany the minor into isolation or quarantine.</text> </paragraph> <paragraph num="(2)"> <text>If the Secretary orders a minor into isolation or quarantine and the minor's parent or guardian is unavailable, the minor shall be isolated or quarantined in a facility where adequate care and supervision are available for the minor.</text> </paragraph> <paragraph num="(3)"> <text>The health officer shall follow the requirements of §I of this regulation in regard to the parent or guardian.</text> </paragraph> </paragraph> <paragraph num="O."> <text>The health officer, in consultation with local health care providers, shall:</text> <paragraph num="(1)"> <text>Recommend to the Secretary when an individual can be released from isolation or quarantine; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the individual who is isolated or quarantined of the date and time of release from isolation or quarantine, as decided by the Secretary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Isolation in a Health Care Facility."> <paragraph num="A."> <text>The administrator of a health care facility shall ensure that isolation of an individual is done using one or more of the following types of isolation precautions and procedures, as defined and prescribed in Guideline for Isolation Precautions in Hospitals:</text> <paragraph num="(1)"> <text>Standard precautions;</text> </paragraph> <paragraph num="(2)"> <text>Airborne precautions;</text> </paragraph> <paragraph num="(3)"> <text>Droplet precautions; or</text> </paragraph> <paragraph num="(4)"> <text>Contact precautions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The administrator of a health care facility shall, at a minimum:</text> <paragraph num="(1)"> <text>Ensure the adequacy of isolation capacity and isolation practices by following the health care facility's isolation procedures;</text> </paragraph> <paragraph num="(2)"> <text>Post a notice at the entrance of an area or a room to inform visitors and staff that the area or room in a health care facility is an isolation site; and</text> </paragraph> <paragraph num="(3)"> <text>Consult with and receive approval from the Secretary before transferring the patient to another site or discharging the patient from the health care facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quarantine in a Health Care Facility."> <paragraph num="A."> <text>The Secretary may quarantine an individual in a health care facility due to a preexisting medical condition of the individual being quarantined or if a health care facility is more appropriate than the individual's home because of medical conditions of family members residing in the individual's home.</text> </paragraph> <paragraph num="B."> <text>The administrator of a health care facility shall:</text> <paragraph num="(1)"> <text>Follow the health care facility's procedures and protocol for quarantine; and</text> </paragraph> <paragraph num="(2)"> <text>Consult with and receive approval from the Secretary before transferring the patient to another site or discharging the patient from the health care facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Isolation and Quarantine in an Individual's Home."> <paragraph num="A."> <text>The Secretary, with assistance from staff at a local health department, local health care facilities, local law enforcement agencies, local social service agencies, or any other local county agencies as needed, may isolate or quarantine in the individual's home an individual who does not require hospitalization or other highly skilled medical care.</text> </paragraph> <paragraph num="B."> <text>The health officer shall:</text> <paragraph num="(1)"> <text>Ensure that appropriate supplies, such as surgical masks, gloves, thermometers, and hand hygiene material, are available to an isolated or quarantined individual; and</text> </paragraph> <paragraph num="(2)"> <text>Depending on the kind of illness of an isolated individual or the suspected illness of a quarantined individual, recommend to the Secretary that the Secretary issue further quarantine orders to ensure that other members of the house are quarantined either at the house as set forth in this regulation or at a nonhealth care facility as set forth in Regulation .07 of this chapter and are provided, at a minimum, with the following:</text> <paragraph num="(a)"> <text>Written or oral information, or both, about the:</text> <paragraph num="(i)"> <text>Infection for which the individual is being isolated or quarantined; and</text> </paragraph> <paragraph num="(ii)"> <text>Precautionary measures the individuals living in the house should exercise while staying in the house where the individual is being isolated or quarantined;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Supplies, such as surgical masks, hand hygiene material, thermometers, and gloves, if appropriate;</text> </paragraph> <paragraph num="(c)"> <text>The local health department phone number; and</text> </paragraph> <paragraph num="(d)"> <text>Other information and supplies determined by the health officer as necessary.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The health officer, in collaboration with local health care practitioners, shall ensure the monitoring of the health of an isolated or quarantined individual, as needed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Isolation and Quarantine in Nonhealth Care Facilities Not Individuals' Homes."> <paragraph num="A."> <text>The Secretary may order an individual, who cannot be accommodated in either a health care facility or the individual's home, into isolation or quarantine in one of the sites listed under §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>A health officer may recommend to the Secretary the following sites for isolation and quarantine:</text> <paragraph num="(1)"> <text>A school;</text> </paragraph> <paragraph num="(2)"> <text>A hotel;</text> </paragraph> <paragraph num="(3)"> <text>A motel;</text> </paragraph> <paragraph num="(4)"> <text>A dormitory; or</text> </paragraph> <paragraph num="(5)"> <text>Another site determined to be appropriate by the local health officer because the site meets the minimum standards for isolation or quarantine as set forth in Regulation .03H of this chapter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health General Article, §§18-904—18-907, Annotated Code of Maryland;Ch. 1, Section 4, Acts of 2002</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 19, 2006 (33:12 Md. R. 998)</annotation> </annotations> </chapter> </subtitle> <subtitle num="60" heading="Board of Environmental Health Specialists"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accredited educational institution” means a college or university in the United States or an equivalent which has been accredited by an accrediting organization or agency that is recognized by the United States Department of Education.</text> </paragraph> <paragraph num="(2)"> <text>“Apprenticeship” means a program of training and experience under the supervision of a licensed environmental health specialist that is a requirement for a Board-approved baccalaureate degree from an accredited educational institution.</text> </paragraph> <paragraph num="(3)"> <text>“Approved experience” means experience which classifies as practice as an environmental health specialist.</text> </paragraph> <paragraph num="(4)"> <text>Approved Training.</text> <paragraph num="(a)"> <text>“Approved training” means Board-approved courses of study or programs of instruction, or courses or programs offered by a pre-approved provider, in an area of environmental health sciences and related subjects designed to improve, advance, or extend professional skill and knowledge relating to the practice of an environmental health specialist.</text> </paragraph> <paragraph num="(b)"> <text>“Approved training” includes, for licensees applying for renewal of a license for the first time, in-training or prior work experience as specified under COMAR 10.60.03.01C(7).</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Board” means the State Board of Environmental Health Specialists.</text> </paragraph> <paragraph num="(6)"> <text>“Board-approved baccalaureate degree” means a baccalaureate degree in science in:</text> <paragraph num="(a)"> <text>Biology;</text> </paragraph> <paragraph num="(b)"> <text>Chemistry;</text> </paragraph> <paragraph num="(c)"> <text>Environmental Science;</text> </paragraph> <paragraph num="(d)"> <text>Geology; or</text> </paragraph> <paragraph num="(e)"> <text>Any other area related to the practice of an environmental health specialist approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Certificate” means any of the following certificates issued by the Board:</text> <paragraph num="(a)"> <text>A certificate of eligibility for obtaining employment; and</text> </paragraph> <paragraph num="(b)"> <text>An environmental health specialist-in-training certificate.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Environmental health specialist-in-training” means an individual who:</text> <paragraph num="(a)"> <text>Meets the educational qualifications set forth in Regulation .03B of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Has a valid environmental health specialist-in-training certificate.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Environmental health specialist-in-training program” means a program which provides an environmental health specialist-in-training with approved experience under the supervision of an environmental health sponsor.</text> </paragraph> <paragraph num="(10)"> <text>Environmental Health Sponsor.</text> <paragraph num="(a)"> <text>“Environmental health sponsor” means an individual who is responsible for overseeing the implementation and progress of an applicant's environmental health specialist-in-training program.</text> </paragraph> <paragraph num="(b)"> <text>“Environmental health sponsor” includes:</text> <paragraph num="(i)"> <text>For public employees, an environmental health director, equivalent agency officer, or their designee; or</text> </paragraph> <paragraph num="(ii)"> <text>For private sector employees, an environmental professional, who, like an environmental health director or equivalent agency supervisor, makes discretionary decisions affecting food safety, water quality, air quality, sewage systems, and other aspects of the environment affecting the public health.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Environmental science degree” means a baccalaureate or master’s degree inclusive of sufficient course and lab work consistent with semester credits or equivalent in quarter credits in physical and biological sciences acceptable to the Board.</text> </paragraph> <paragraph num="(12)"> <text>“Full-time employment” means employment of at least 34 hours per week.</text> </paragraph> <paragraph num="(13)"> <text>“Hours of approved training” means the value given by the Board for participation in continuing education or experience.</text> </paragraph> <paragraph num="(14)"> <text>“Internship” means an environmental health specialist-in-training program that:</text> <paragraph num="(a)"> <text>Consists of 3 months of approved experience; and</text> </paragraph> <paragraph num="(b)"> <text>Has been completed by an individual who has graduated from an accredited educational institution with a master’s degree in public or environmental health.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Laboratory course” means a traditional on-site setting or virtual setting where an individual conducts practical experiments by either:</text> <paragraph num="(a)"> <text>Hands on; or</text> </paragraph> <paragraph num="(b)"> <text>Simulation relative to the subject area.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“License” means a license issued by the Board to practice as an environmental health specialist.</text> </paragraph> <paragraph num="(17)"> <text>“License renewal period” means the 24-month period immediately preceding the expiration date of the license.</text> </paragraph> <paragraph num="(18)"> <text>“Licensed environmental health specialist” means an individual who is licensed by the Board to practice as an environmental health specialist.</text> </paragraph> <paragraph num="(19)"> <text>Major Component of Employment.</text> <paragraph num="(a)"> <text>“Major component of employment” means a job duty or responsibility that:</text> <paragraph num="(i)"> <text>An individual may be reasonably expected to perform;</text> </paragraph> <paragraph num="(ii)"> <text>Is identified and listed separately on a position description form such as a Maryland State form MS-22; and</text> </paragraph> <paragraph num="(iii)"> <text>Entails significant decision-making responsibility and authority in the process of securing compliance with federal, State, or local health and environmental laws and regulations specifically relating to the control of the public health aspects of the environment.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Major component of employment” does not include a job duty or responsibility identified as miscellaneous or other duties as assigned.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Party.</text> <paragraph num="(a)"> <text>“Party” means a person or agency named or admitted as a party, or properly seeking and entitled to the right to be admitted as a party, in formal hearings.</text> </paragraph> <paragraph num="(b)"> <text>“Party” includes a person or agency admitted for limited purposes.</text> </paragraph> </paragraph> <paragraph num="(21)"> <text>“Permanent employee” means an individual who is:</text> <paragraph num="(a)"> <text>Employed to practice as an environmental health specialist; and</text> </paragraph> <paragraph num="(b)"> <text>Not a temporary employee.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Practice as an environmental health specialist” means, as a major component of employment, to apply academic principles, methods, and procedures of the environmental, physical, biological, and health sciences to the inspections and investigations necessary to collect and analyze data and to make decisions necessary to secure compliance with federal, State, and local health and environmental laws and regulations specifically relating to control of the public health aspects of the environment including:</text> <paragraph num="(a)"> <text>The manufacture, preparation, handling, distribution, or sale of food and milk;</text> </paragraph> <paragraph num="(b)"> <text>Water supply and treatment;</text> </paragraph> <paragraph num="(c)"> <text>Wastewater treatment and disposal;</text> </paragraph> <paragraph num="(d)"> <text>Solid waste management and disposal;</text> </paragraph> <paragraph num="(e)"> <text>Vector control;</text> </paragraph> <paragraph num="(f)"> <text>Insect and rodent control;</text> </paragraph> <paragraph num="(g)"> <text>Air quality;</text> </paragraph> <paragraph num="(h)"> <text>Noise control;</text> </paragraph> <paragraph num="(i)"> <text>Product safety;</text> </paragraph> <paragraph num="(j)"> <text>Recreational sanitation; and</text> </paragraph> <paragraph num="(k)"> <text>Institutional and residential sanitation.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Subject matter expert” means an individual with in-depth knowledge or expertise in performing a specialized job, duty or skill within an organization.</text> </paragraph> <paragraph num="(24)"> <text>“Temporary employee” means an individual who is:</text> <paragraph num="(a)"> <text>Employed to practice as an environmental health specialist on a temporary basis for a length of time not to exceed 6 consecutive months within a consecutive 12-month period; and</text> </paragraph> <paragraph num="(b)"> <text>Not required to complete the total months of experience in an environmental health specialist-in-training program under Regulation .03B of this chapter on a consecutive monthly basis.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Prohibitions."> <paragraph num="A."> <text>An individual may not practice as an environmental health specialist in the State unless the individual is:</text> <paragraph num="(1)"> <text>Licensed by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Employed under a valid environmental health specialist-in-training certificate issued by the Board; or</text> </paragraph> <paragraph num="(3)"> <text>Participating in an apprenticeship approved by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual may not practice as an environmental health specialist under an environmental health specialist-in-training certificate for more than a total of 3 years, unless approved by the Board in accordance with COMAR 10.60.02.05B.</text> </paragraph> <paragraph num="C."> <text>Pursuant to Health Occupations Article, §21–401, Annotated Code of Maryland, unless an individual is licensed under this chapter, an individual may not use the title “environmental health specialist” or “licensed environmental health specialist” or the initials “E.H.S.” or “L.E.H.S.” after the name of the individual or any other title with the intent to represent that the individual is licensed to practice as an environmental health specialist.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensing and Examination."> <paragraph num="A."> <text>The Board shall license an applicant if the applicant:</text> <paragraph num="(1)"> <text>Qualifies for examination as provided in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Takes and passes the examination;</text> </paragraph> <paragraph num="(3)"> <text>Has not committed an act which, under Health Occupation Article, §21-312, would subject the applicant to disciplinary action by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>Pays the necessary fees as specified in COMAR 10.60.06.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant is eligible to take the examination if the applicant has satisfied one of the following combinations of education and experience:</text> <paragraph num="(1)"> <text>Combination 1:</text> <paragraph num="(a)"> <text>Graduated from an accredited educational institution with a baccalaureate degree that includes:</text> <paragraph num="(i)"> <text>A minimum of 30 semester credit hours or the equivalent quarter [credits] credit hours of chemical, physical, biological, and environmental sciences acceptable to the Board;</text> </paragraph> <paragraph num="(ii)"> <text>A course in mathematics; and</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory coursework as required in §C of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has either:</text> <paragraph num="(i)"> <text>Obtained 12 months of experience in an environmental health specialist-in-training program approved by the Board; or</text> </paragraph> <paragraph num="(ii)"> <text>Completed an apprenticeship approved by the Board; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Combination 2:</text> <paragraph num="(a)"> <text>Graduated from an accredited educational institution with a master’s degree in public or environmental health science that includes:</text> <paragraph num="(i)"> <text>A minimum of 30 semester credit hours or 45 quarter credit hours of chemical, physical, biological, or environmental sciences acceptable to the Board;</text> </paragraph> <paragraph num="(ii)"> <text>A course in mathematics; and</text> </paragraph> <paragraph num="(iii)"> <text>Laboratory coursework as required in §C of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Completed an internship.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Laboratory Coursework.</text> <paragraph num="(1)"> <text>Except as provided in §C(2) of this regulation, laboratory coursework shall be in the following fields:</text> <paragraph num="(a)"> <text>Chemistry;</text> </paragraph> <paragraph num="(b)"> <text>Physics;</text> </paragraph> <paragraph num="(c)"> <text>Biology;</text> </paragraph> <paragraph num="(d)"> <text>Geographic information systems;</text> </paragraph> <paragraph num="(e)"> <text>Soil science; and</text> </paragraph> <paragraph num="(f)"> <text>Geological science.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may accept a health or environmental field not listed in §C(1) of this regulation if the Board determines that the field is sufficiently related to the practice of an environmental health specialist.</text> </paragraph> <paragraph num="(3)"> <text>An applicant shall have completed at least:</text> <paragraph num="(a)"> <text>One laboratory course in two of the fields listed in §C(1) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Four laboratory courses in one of the fields listed in §C(1) of this regulation; or</text> </paragraph> <paragraph num="(c)"> <text>Two laboratory courses in one or more of the fields accepted by the Board in accordance with §C(2) of this regulation.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Waivers."> <paragraph num="A."> <text>The Board may waive any examination requirement under this chapter if:</text> <paragraph num="(1)"> <text>The Board considers the applicant to be recognized as outstanding in the field of environmental health as stated in COMAR 10.60.02.04L; or</text> </paragraph> <paragraph num="(2)"> <text>The applicant has:</text> <paragraph num="(a)"> <text>Satisfied the education and experience requirements set forth in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Passed an examination as a condition of licensure or registration in another state;</text> </paragraph> <paragraph num="(c)"> <text>Been licensed or registered as an environmental health specialist or its equivalent in another state; and</text> </paragraph> <paragraph num="(d)"> <text>Performed at least 24 months of compensated work as an environmental health specialist or its equivalent in the other state.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant who satisfies §A of this regulation shall pay to the Board the application and license fees established by COMAR 10.60.06 before receiving a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Environmental Health Specialist-in-Training Program."> <paragraph num="A."> <text>The purpose of an environmental health specialist-in-training program shall be to prepare the environmental health specialist-in-training to:</text> <paragraph num="(1)"> <text>Perform in a competent manner assigned job duties and responsibilities which constitute practice as an environmental health specialist; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate proficiency in all areas of public and environmental health on a written examination required by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At a minimum, an environmental health specialist-in-training program shall:</text> <paragraph num="(1)"> <text>Provide the environmental health specialist-in-training with approved experience that is in accordance with §E of this regulation and which includes the following:</text> <paragraph num="(a)"> <text>Conducting inspections and investigations;</text> </paragraph> <paragraph num="(b)"> <text>Collecting and analyzing data;</text> </paragraph> <paragraph num="(c)"> <text>Making decisions necessary to secure compliance with federal, State, and local laws and regulations that relate to control of the public health aspects of the environment; and</text> </paragraph> <paragraph num="(d)"> <text>Reviewing and approving plans for compliance or process changes; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide the environmental health specialist-in-training with an opportunity for education and training in the:</text> <paragraph num="(a)"> <text>Areas identified in Regulation .01B(20) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Subject areas included in the recognized examination approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The environmental health sponsor of an environmental health specialist-in-training program shall:</text> <paragraph num="(1)"> <text>Ensure that the program complies with §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Provide in house training and opportunities for outside training events; and</text> </paragraph> <paragraph num="(3)"> <text>Define and track progress through the performance evaluation process.</text> </paragraph> </paragraph> <paragraph num="D."> <text>As part of the implementation of the in-training program, the environmental health specialist-in-training shall:</text> <paragraph num="(1)"> <text>Review recommended resource materials;</text> </paragraph> <paragraph num="(2)"> <text>Attend recommended training events to improve breadth and depth of knowledge;</text> </paragraph> <paragraph num="(3)"> <text>Receive satisfactory or above performance evaluation ratings for the entire in-training program; and</text> </paragraph> <paragraph num="(4)"> <text>With the sponsor’s input, establish a timeline for when to take the examination.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Experience Requirements.</text> <paragraph num="(1)"> <text>Experience obtained under the direction of the environmental health sponsor shall be credited toward the experience requirements of an environmental health specialist-in-training program.</text> </paragraph> <paragraph num="(2)"> <text>The amount of approved experience required for each environmental health specialist-in-training program shall be in accordance with Regulation .03B of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>The Board may approve and apply experience that was obtained from prior employment as part of an environmental health specialist-in-training program.</text> </paragraph> <paragraph num="(4)"> <text>Approved experience shall be credited to an environmental health specialist-in-training as follows:</text> <paragraph num="(a)"> <text>Each month of full time employment is credited as 1 month of experience;</text> </paragraph> <paragraph num="(b)"> <text>Each month of less than full-time employment is credited on a prorated basis; and</text> </paragraph> <paragraph num="(c)"> <text>No experience credit is given for any month during which the environmental health specialist-in-training's job performance is rated as unsatisfactory in writing by that individual’s supervisor.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Except for an internship approved by an environmental health sponsor, approved experience does not include experience obtained to satisfy the degree requirements of an academic institution.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Apprenticeships."> <paragraph num="A."> <text>The Board shall approve an apprenticeship if the apprenticeship provider:</text> <paragraph num="(1)"> <text>Submits an application for approval on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Submits satisfactory evidence that the training and experience provided to an apprenticeship participant meets the requirements of §§B—G of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An apprenticeship shall be under the supervision of an environmental health specialist actively licensed in the State.</text> </paragraph> <paragraph num="C."> <text>An apprenticeship shall be rendered as a part of a Board-approved baccalaureate degree from an accredited institution.</text> </paragraph> <paragraph num="D."> <text>Apprenticeship Written Plan. An apprenticeship shall be provided pursuant to a written plan that:</text> <paragraph num="(1)"> <text>Establishes any employment requirements for the apprenticeship participant; and</text> </paragraph> <paragraph num="(2)"> <text>Defines the methods for tracking and evaluating participant performance.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An apprenticeship shall prepare the participant to:</text> <paragraph num="(1)"> <text>Perform, in a competent manner, assigned job duties and responsibilities which constitute practice as an environmental health specialist; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate proficiency in all areas of public and environmental health on a written examination required by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Education and Training. An apprenticeship shall provide the participant with education and training in:</text> <paragraph num="(1)"> <text>The manufacture, preparation, handling, distribution, or sale of food and milk;</text> </paragraph> <paragraph num="(2)"> <text>Water supply and treatment;</text> </paragraph> <paragraph num="(3)"> <text>Wastewater treatment and disposal;</text> </paragraph> <paragraph num="(4)"> <text>Solid waste management and disposal;</text> </paragraph> <paragraph num="(5)"> <text>Vector control;</text> </paragraph> <paragraph num="(6)"> <text>Insect and rodent control;</text> </paragraph> <paragraph num="(7)"> <text>Air quality;</text> </paragraph> <paragraph num="(8)"> <text>Noise control;</text> </paragraph> <paragraph num="(9)"> <text>Product safety;</text> </paragraph> <paragraph num="(10)"> <text>Recreational sanitation;</text> </paragraph> <paragraph num="(11)"> <text>Institutional and residential sanitation; and</text> </paragraph> <paragraph num="(12)"> <text>Subject areas included in the recognized examination approved by the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Apprenticeship Experience Requirements. An apprenticeship shall provide the participant with experience in the following skills:</text> <paragraph num="(1)"> <text>Conducting inspections and investigations;</text> </paragraph> <paragraph num="(2)"> <text>Collecting and analyzing data;</text> </paragraph> <paragraph num="(3)"> <text>Making decisions necessary to secure compliance with federal, State, and local laws and regulations that relate to control of the public health aspects of the environment; and</text> </paragraph> <paragraph num="(4)"> <text>Reviewing and approving plans for compliance or process changes.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The minimum duration of an apprenticeship shall be 6 months.</text> </paragraph> <paragraph num="I."> <text>The maximum duration of an apprenticeship shall be 5 years.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§21-101—21-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective November 9, 2015 (42:22 Md. R. 1379); June 28, 2021 (48:13 Md. R. 508); May 1, 2023 (50:8 Md. R. 338); January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C adopted effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 9, 2015 (42:22 Md. R. 1379); March 13, 2017 (44:5 Md. R. 294); June 28, 2021 (48:13 Md. R. 508); August 5, 2024 (51:15 Md. R. 710); January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation ,03C adopted effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 9, 2015 (42:22 Md. R. 1379); March 13, 2017 (44:5 Md. R. 294); June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 9, 2015 (42:22 Md. R. 1379); March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective April 23, 2018 (45:8 Md. R. 422); August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective January 5, 2026 (52:26 Md. R. 1309)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensing Procedures"> <regulation prefix="Regulation" num=".01" heading="Application Procedure."> <paragraph num="A."> <text>An individual applying for a license or certificate of eligibility shall:</text> <paragraph num="(1)"> <text>Submit the appropriate application in writing on a form provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the application fee established by COMAR 10.60.06;</text> </paragraph> <paragraph num="(3)"> <text>Have official transcripts of all baccalaureate and post-baccalaureate studies submitted in accordance with §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Have verification of previous experience, if applicable, submitted in accordance with §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Transcripts.</text> <paragraph num="(1)"> <text>Official transcripts of all baccalaureate and post-baccalaureate studies shall be submitted directly to the Board from the appropriate educational institutions.</text> </paragraph> <paragraph num="(2)"> <text>If official transcripts are not available, the Board may accept other evidence certifying successful completion of course work considered equivalent by the Board.</text> </paragraph> <paragraph num="(3)"> <text>A graduate of a college or university that is not an accredited educational institution shall provide written documentation from an evaluation service, or other source acceptable to the Board, which:</text> <paragraph num="(a)"> <text>States that the institution’s program of study is substantially equivalent to that of accredited educational institutions; and</text> </paragraph> <paragraph num="(b)"> <text>Shows that the course work completed by the applicant satisfies the requirements of COMAR 10.60.01.03B.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For apprenticeship graduates, the educational institution shall, as part of the official transcript, submit documentation, such as a certificate of completion, that the applicant satisfactorily completed the apprenticeship.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for a license who claims experience as an environmental health specialist shall provide to the Board independent written verification from the applicant’s employer describing the nature and duration of the applicant’s experience.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Incomplete Application."> <paragraph num="A."> <text>The Board:</text> <paragraph num="(1)"> <text>May not take any action on an incomplete application; and</text> </paragraph> <paragraph num="(2)"> <text>Shall notify the applicant of the need for additional information within 45 days of receipt of the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An application is not complete until all required material, including the fee and supporting documentation, is received by the Board.</text> </paragraph> <paragraph num="C."> <text>An incomplete application shall be held for 1 year from the date of initial receipt, after which the application is invalid.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Action on an Application."> <paragraph num="A."> <text>The Board shall notify an applicant in writing that:</text> <paragraph num="(1)"> <text>The applicant qualifies for a license under COMAR 10.60.01.03 or .04;</text> </paragraph> <paragraph num="(2)"> <text>The applicant qualifies for:</text> <paragraph num="(a)"> <text>Examination under COMAR 10.60.01.03; or</text> </paragraph> <paragraph num="(b)"> <text>A certificate of eligibility under COMAR 10.60.02.05;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The applicant does not qualify to receive a license or a certificate of eligibility, or to take the examination, for one or more of the reasons set forth in §C of this regulation; or</text> </paragraph> <paragraph num="(4)"> <text>The application is incomplete, the reasons the application is incomplete, and that the application will be invalid in 1 year.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Payment of License Fee.</text> <paragraph num="(1)"> <text>Following notification of license approval, the applicant shall pay to the Board the licensing fee established in COMAR 10.60.06.</text> </paragraph> <paragraph num="(2)"> <text>The license may not be issued until the fee is paid to the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Denial of an Application.</text> <paragraph num="(1)"> <text>The Board shall deny an application if the Board determines that the applicant:</text> <paragraph num="(a)"> <text>Has failed to demonstrate that the applicant qualifies for licensure, examination, or issuance of a certificate in accordance with §A(1) or (2) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Has committed any act which, under Health Occupations Article, §21-312, Annotated Code of Maryland, would subject the licensee to disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board denies an application, the Board shall:</text> <paragraph num="(a)"> <text>Notify the applicant by first-class mail and electronic means of the reasons for denial;</text> </paragraph> <paragraph num="(b)"> <text>Advise the applicant of the procedures for reconsideration under §D of this regulation if the application was denied under §C(1)(a) of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Follow the procedures set forth in COMAR 10.60.04 if the application was denied under §C(1)(b) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Reconsideration.</text> <paragraph num="(1)"> <text>If the Board denies an application for licensure under Regulation .03C(1)(a) of this chapter, or denies an application to renew a license under Regulation .06 of this chapter, the applicant may request reconsideration of the denial by submitting new or additional information to the Board.</text> </paragraph> <paragraph num="(2)"> <text>Requests for reconsideration under §D(1) of this regulation shall be based on one or more of the following grounds:</text> <paragraph num="(a)"> <text>Clerical errors in the minutes, decisions, or other parts of the record related to the denial;</text> </paragraph> <paragraph num="(b)"> <text>Mistake of fact or law by the Board;</text> </paragraph> <paragraph num="(c)"> <text>Irregularity in the administrative proceedings related to, or in the consideration of, the application;</text> </paragraph> <paragraph num="(d)"> <text>Newly discovered or additional evidence that the applicant could not have discovered by due diligence in time to be considered as part of the initial denial.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Requests for reconsideration shall be submitted to the Board in writing by certified mail within 30 days of receipt of the denial under §C of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Examination."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Authorize a recognized examination agency to administer the examination on behalf of the Board; or</text> </paragraph> <paragraph num="(2)"> <text>Administer an examination prepared by a recognized examination agency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The examination shall be:</text> <paragraph num="(1)"> <text>Standardized and prepared by a recognized examination agency; and</text> </paragraph> <paragraph num="(2)"> <text>Held at least once a year.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall provide the:</text> <paragraph num="(1)"> <text>List of eligible applicants and their eligibility expiration date to an authorized examination agency;</text> </paragraph> <paragraph num="(2)"> <text>For applicants who have satisfied education and experience requirements set forth under COMAR 10.60.01.03, notice of eligibility to sit for the examination;</text> </paragraph> <paragraph num="(3)"> <text>Examination information for eligible applicants on the Board’s website;</text> </paragraph> <paragraph num="(4)"> <text>Results of the examination to the applicant; and</text> </paragraph> <paragraph num="(5)"> <text>For applicants who receive a passing score, instructions on securing a license.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The notice of eligibility to an applicant shall include the:</text> <paragraph num="(1)"> <text>Date the:</text> <paragraph num="(a)"> <text>Applicant is eligible to sit for the examination; and</text> </paragraph> <paragraph num="(b)"> <text>Eligibility to sit for the examination expires; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Procedure to:</text> <paragraph num="(a)"> <text>Register to sit for the examination;</text> </paragraph> <paragraph num="(b)"> <text>Pay the fee for examination; and</text> </paragraph> <paragraph num="(c)"> <text>Retake the examination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The authorized examination agency shall:</text> <paragraph num="(1)"> <text>Collect the examination fee from the applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Provide examination results to the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Passing Score. The passing score for the examination shall be determined by the recognized examination agency.</text> </paragraph> <paragraph num="G."> <text>An applicant who has not previously taken the written examination is permitted to sit for an examination if the applicant has:</text> <paragraph num="(1)"> <text>Received a notice of eligibility from the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Paid an examination fee as established by COMAR 10.60.06.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An applicant who fails the examination may retake the examination if the applicant:</text> <paragraph num="(1)"> <text>Submits an application on a form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>Pays any applicable examination fees.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Board may waive any examination requirement under this regulation if the Board considers the applicant to be recognized as outstanding in the field of environmental health.</text> </paragraph> <paragraph num="J."> <text>To be recognized as outstanding in the field of environmental health by the Board, an applicant shall:</text> <paragraph num="(1)"> <text>Meet the criteria set forth in COMAR 10.60.01.03 and 10.60.02.01 for an environmental health specialist-in-training;</text> </paragraph> <paragraph num="(2)"> <text>Be considered a subject matter expert by the Board in one or more of the following areas:</text> <paragraph num="(a)"> <text>The manufacture, preparation, handling, distribution, or sale of food and milk;</text> </paragraph> <paragraph num="(b)"> <text>Water supply and treatment;</text> </paragraph> <paragraph num="(c)"> <text>Wastewater treatment and disposal;</text> </paragraph> <paragraph num="(d)"> <text>Solid waste management and disposal;</text> </paragraph> <paragraph num="(e)"> <text>Vector control;</text> </paragraph> <paragraph num="(f)"> <text>Insect and rodent control;</text> </paragraph> <paragraph num="(g)"> <text>Air quality;</text> </paragraph> <paragraph num="(h)"> <text>Noise control;</text> </paragraph> <paragraph num="(i)"> <text>Product safety;</text> </paragraph> <paragraph num="(j)"> <text>Recreational sanitation; or</text> </paragraph> <paragraph num="(k)"> <text>Institutional and residential sanitation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Demonstrate at least one of the following career pathways with a minimum of 15 years of progressive responsibilities with:</text> <paragraph num="(a)"> <text>Technical knowledge and experience, including obtaining a master’s or doctoral degree in an environmental or public health-related area, wherein the time devoted to technical scientific research may be applied towards the minimum time criteria as follows:</text> <paragraph num="(i)"> <text>If obtaining a master’s degree, 1 year; or</text> </paragraph> <paragraph num="(ii)"> <text>If obtaining a doctoral degree, 2 years;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A managerial hierarchy similar to that of an environmental health specialist, such as:</text> <paragraph num="(i)"> <text>Health specialist in training;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed environmental health specialist;</text> </paragraph> <paragraph num="(iii)"> <text>Supervisor;</text> </paragraph> <paragraph num="(iv)"> <text>Program manager; or</text> </paragraph> <paragraph num="(v)"> <text>Director; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>A combination of §L(3)(a) or (b) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Demonstrate and document involvement in an area listed in §L(2) of this regulation, in at least one of the following activities:</text> <paragraph num="(a)"> <text>Research;</text> </paragraph> <paragraph num="(b)"> <text>Has been published in peer review publications;</text> </paragraph> <paragraph num="(c)"> <text>Has given court testimony or served as an expert witness qualified by a court system;</text> </paragraph> <paragraph num="(d)"> <text>Has teaching experience; or</text> </paragraph> <paragraph num="(e)"> <text>Where applicable, received a professional license through a Maryland or other recognized licensure body in the applicant’s field.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Certificates."> <paragraph num="A."> <text>Certificate of Eligibility for Obtaining Employment.</text> <paragraph num="(1)"> <text>The Board shall issue a certificate of eligibility for obtaining employment to an applicant who:</text> <paragraph num="(a)"> <text>Meets the educational requirements set forth in COMAR 10.60.01.03;</text> </paragraph> <paragraph num="(b)"> <text>Has submitted an application in accordance with Regulation .01 of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Is not currently practicing as an environmental health specialist in Maryland; and</text> </paragraph> <paragraph num="(d)"> <text>Has not previously completed an environmental health specialist-in-training program under an environmental health specialist-in-training certificate issued by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The certificate of eligibility for obtaining employment shall expire 12 months after the issuance date and may be renewed at 12-month increments if the certificate holder:</text> <paragraph num="(a)"> <text>Submits a request for renewal prior to expiration of the certificate on a form provided by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Forwards the form to the Board together with the renewal fee established by COMAR 10.60.06.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Environmental Health Specialist-In-Training Certificates.</text> <paragraph num="(1)"> <text>The Board shall issue an environmental health specialist-in-training certificate to an applicant who has been employed to practice as an environmental health specialist under a certificate of eligibility for obtaining employment issued by the Board if the applicant:</text> <paragraph num="(a)"> <text>Has returned a completed certificate of eligibility for obtaining employment to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Is participating in an environmental health specialist-in-training program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The environmental health specialist-in-training certificate shall expire 36 months after its effective date unless the expiration date has been extended in writing by the Board in accordance with §B(4) or (6) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Board may not renew an environmental health specialist-in-training certificate for which the expiration date has been extended.</text> </paragraph> <paragraph num="(4)"> <text>Upon a written request from the holder of an environmental health specialist-in-training certificate prior to the expiration date of the certificate, the Board may extend an environmental health specialist-in-training certificate for up to 6 months due to physical incapacitation of the environmental health specialist-in-training or for other reasons acceptable to the Board.</text> </paragraph> <paragraph num="(5)"> <text>The Board may place the environmental health specialist-in-training certificate on inactive status due to reasons acceptable to the Board upon a written request from the holder of an environmental health specialist-in-training certificate.</text> </paragraph> <paragraph num="(6)"> <text>The Board may reactivate the environmental health specialist-in-training certificate within the original 36 month period with an expiration date that reflects the balance of remaining time for training:</text> <paragraph num="(a)"> <text>Upon a written request from an individual whose environmental health specialist-in-training certificate is inactive; and</text> </paragraph> <paragraph num="(b)"> <text>Along with a letter of support from a sponsor.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the holder of an environmental health specialist-in-training certificate is a temporary employee as defined in COMAR 10.60.01.01, the Board, upon written request from the holder of the environmental health specialist-in-training certificate and upon receipt of the renewal fee as required by COMAR 10.60.06, may renew a valid certificate for a period of 24 months.</text> </paragraph> <paragraph num="(8)"> <text>If a temporary employee is hired as or otherwise converted to a permanent employee:</text> <paragraph num="(a)"> <text>The employee shall submit the employee’s current environmental health specialist-in-training certificate to the Board within 30 days;</text> </paragraph> <paragraph num="(b)"> <text>Upon receipt of the certificate referenced in §D(6)(a) of this regulation, the Board shall renew a new environmental health specialist-in-training certificate that is valid for 36 months; and</text> </paragraph> <paragraph num="(c)"> <text>The Board may reduce the required number of months of experience in an environmental health specialist-in-training program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Expiration and Renewal of Licenses."> <paragraph num="A."> <text>Expiration. After June 30, 2023, licenses shall expire pursuant to the following schedule:</text> <paragraph num="(1)"> <text>The license of a licensee with an even-numbered birth year shall expire on June 30 of an even-numbered year; and</text> </paragraph> <paragraph num="(2)"> <text>The license of a licensee with an odd-numbered birth year shall expire on June 30 of an odd-numbered year</text> </paragraph> </paragraph> <paragraph num="B."> <text>Conditions for License Renewal.</text> <paragraph num="(1)"> <text>Except as provided in §B(2) and (3) of this regulation, the Board shall renew a license for a 2-year period if the licensee has:</text> <paragraph num="(a)"> <text>Submitted an application for renewal to the Board before the expiration date of the license;</text> </paragraph> <paragraph num="(b)"> <text>Paid the renewal fee established by COMAR 10.60.06;</text> </paragraph> <paragraph num="(c)"> <text>Submitted satisfactory proof to the Board that the licensee has completed at least 20 clock hours of approved training during the license renewal period; and</text> </paragraph> <paragraph num="(d)"> <text>Not committed any act which, under Health Occupations Article, §21-312, Annotated Code of Maryland, would subject the licensee to disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For licenses expiring on June 30, 2023 only, the Board shall renew the license of a licensee with an even-numbered birth year for a 1-year period if the licensee meets the requirements set forth under §B(1) of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>For licenses expiring on June 30, 2024 only, the Board shall renew a license for a 2-year period if the licensee has:</text> <paragraph num="(a)"> <text>Submitted an application for renewal to the Board before the expiration date of the license;</text> </paragraph> <paragraph num="(b)"> <text>Paid the renewal fee established by COMAR 10.60.06;</text> </paragraph> <paragraph num="(c)"> <text>Submitted satisfactory proof to the Board that the licensee has completed at least 10 clock hours of approved training during the 1-year period immediately preceding the license expiration date; and</text> </paragraph> <paragraph num="(d)"> <text>Not committed any act which, under Health Occupations Article, §21-312, Annotated Code of Maryland, would subject the licensee to disciplinary action by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Board may deny the application to renew a license if the applicant has failed to satisfy the requirements of §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Renewal Notification.</text> <paragraph num="(1)"> <text>Before the expiration of a license, the Board shall notify the licensee of the need to renew the license.</text> </paragraph> <paragraph num="(2)"> <text>The failure of a licensee to receive a renewal notice does not:</text> <paragraph num="(a)"> <text>Relieve the licensee of the obligation to renew the license; and</text> </paragraph> <paragraph num="(b)"> <text>Affect the expiration of the license.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Duplicate License."> <text>A licensee may obtain a duplicate license to replace a license that has been lost, destroyed, or mutilated if the licensee:</text> <paragraph num="A."> <text>Makes a written request to the Board that states the reason for requesting a duplicate license; and</text> </paragraph> <paragraph num="B."> <text>Pays to the Board the duplicate license fee established by COMAR 10.60.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inactive Status."> <paragraph num="A."> <text>The Board shall place a licensed environmental health specialist on inactive status for a period not to exceed 4 years if the licensee:</text> <paragraph num="(1)"> <text>Submits to the Board a written application for inactive status on a form the board requires; and</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the inactive status fee set by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall provide to a licensed environmental health specialist who is placed on inactive status written notification of:</text> <paragraph num="(1)"> <text>The date the license has or will expire;</text> </paragraph> <paragraph num="(2)"> <text>The date the inactive status became effective;</text> </paragraph> <paragraph num="(3)"> <text>The date the inactive status expires; and</text> </paragraph> <paragraph num="(4)"> <text>The consequences of not reactivating the license before the inactive status expires.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in Regulation .10 of this chapter, the Board shall reactivate the license of a licensed environmental health specialist who is on inactive status if the licensee:</text> <paragraph num="(1)"> <text>Applies to the Board for reactivation of the license before the inactive status expires;</text> </paragraph> <paragraph num="(2)"> <text>Complies with the license renewal requirements that are in effect when the licensee applies for reactivation;</text> </paragraph> <paragraph num="(3)"> <text>Has completed 20 credit hours of approved continuing education in the past 24 month period; and</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Board the reactivation fee established by COMAR 10.60.06(7).</text> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant for reactivation of a license shall submit to the Board documentation of completion of approved training as set forth in COMAR 10.60.03.04E.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Non-Renewed Status."> <paragraph num="A."> <text>The Board shall place a licensed environmental health specialist on non-renewed status for a period not to exceed 4 years if the licensed environmental health specialist fails to renew the license for any reason.</text> </paragraph> <paragraph num="B."> <text>The Board shall provide to the licensee who is placed on nonrenewed status written notification of:</text> <paragraph num="(1)"> <text>The date the license expired;</text> </paragraph> <paragraph num="(2)"> <text>The date the non-renewed status became effective;</text> </paragraph> <paragraph num="(3)"> <text>The date the non-renewed status expires; and</text> </paragraph> <paragraph num="(4)"> <text>The consequences of not reactivating the license before the non-renewed status expires.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in Regulation .10 of this chapter, the Board shall reactivate the license of a licensed environmental health specialist who is on non-renewed status if the individual:</text> <paragraph num="(1)"> <text>Applies to the Board for reactivation of the license before the non-renewed status expires;</text> </paragraph> <paragraph num="(2)"> <text>Complies with the license renewal requirements that are in effect when the individual applies for reactivation;</text> </paragraph> <paragraph num="(3)"> <text>Has completed 20 credit hours of approved continuing education in the past 24 month period; and</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Board the reactivation fee established by COMAR 10.60.06.D. An applicant for reactivation of a license shall submit to the Board documentation of completion of approved training as set forth in COMAR 10.60.03.04E.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant for reactivation of a license shall submit to the Board documentation of completion of approved training as set forth in COMAR 10.60.03.04E.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reactivation."> <text>Notwithstanding Regulations .08 and .09 of this chapter, the Board shall reactivate the license of a licensed environmental health specialist who was placed on inactive or non-renewed status if the individual:</text> <paragraph num="A."> <text>Applies to the Board for reactivation after the inactive or non-renewed status expired;</text> </paragraph> <paragraph num="B."> <text>Pays to the Board the reactivation fee established by COMAR 10.60.06;</text> </paragraph> <paragraph num="C."> <text>Provides any documentation required by the Board; and</text> </paragraph> <paragraph num="D."> <text>Passes the examination that is required at time of reactivation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§21-101—21-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 28, 2021 (48:13 Md. R. 508); January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, E amended effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F, G adopted effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G amended effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04I, J amended effective January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective November 9, 2015 (42:22 Md. R. 1379); January 5, 2026 (52:26 Md. R. 1309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C repealed effective May 20, 2019 (46:10 Md. R. 490)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed and new Regulation .08 adopted effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D adopted as an emergency provision effective January 9, 2024 (51:3 Md. R. 153); emergency status expired effective July 7, 2024; adopted permanently effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective November 9, 2015 (42:22 Md. R. 1379)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 153); emergency status expired effective July 7, 2024; amended permanently effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09D adopted as an emergency provision effective January 9, 2024 (51:3 Md. R. 153); emergency status expired effective July 7, 2024; adopted permanently effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 adopted effective November 9, 2015 (42:22 Md. R. 1379)</annotation> </annotations> </chapter> <chapter num="03" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Approval of Training."> <paragraph num="A."> <text>The Board shall approve and credit training that meets the requirements of this regulation.</text> </paragraph> <paragraph num="B."> <text>Approved training shall be designed to improve, advance, or extend professional skill and knowledge relating to the practice of an environmental health specialist.</text> </paragraph> <paragraph num="C."> <text>Approved training may consist of participation in any of the following:</text> <paragraph num="(1)"> <text>College-level or post-graduate course work given by an accredited educational institution;</text> </paragraph> <paragraph num="(2)"> <text>Courses, seminars, workshops, or lectures;</text> </paragraph> <paragraph num="(3)"> <text>Extension studies, on-line courses, and correspondence courses, if there is satisfactory proof of completion, acceptable to the Board;</text> </paragraph> <paragraph num="(4)"> <text>In-service training, if there is satisfactory proof of completion;</text> </paragraph> <paragraph num="(5)"> <text>Authoring a paper published in a professional journal requiring peer review;</text> </paragraph> <paragraph num="(6)"> <text>Instruction of approved training courses; or</text> </paragraph> <paragraph num="(7)"> <text>For licensees applying for renewal for the first time:</text> <paragraph num="(a)"> <text>On-the-job training in an environmental health specialist-in-training program under the supervision of an environmental health sponsor; or</text> </paragraph> <paragraph num="(b)"> <text>Practice as an environmental health specialist or its equivalent in another state or territory of the United States, as approved by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Determination of Hours of Approved Training. The Board shall determine the hours of approved training as follows:</text> <paragraph num="(1)"> <text>For courses for which continuing education units (CEUs) have been assigned, 1 CEU is equivalent to 10 clock or classroom hours of approved training;</text> </paragraph> <paragraph num="(2)"> <text>For courses given in educational institutions, 1 hour of classroom training is equivalent to 1 hour of approved training;</text> </paragraph> <paragraph num="(3)"> <text>For training such as online courses, correspondence courses, extension studies, authored papers, and any other approved training, the Board shall determine the hours of approved training on a case-by-case basis;</text> </paragraph> <paragraph num="(4)"> <text>For instruction of an approved training course, the Board shall grant:</text> <paragraph num="(a)"> <text>1 hour of training for 1 hour of instruction;</text> </paragraph> <paragraph num="(b)"> <text>Up to 10 hours of training per license renewal period; and</text> </paragraph> <paragraph num="(c)"> <text>Hours as an instructor only once per license renewal period for each training course; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For licensees applying for renewal for the first time, the Board shall grant 5 hours of approved training for each full 6-month period that the licensee participated in training or work experience listed in §C(7) of this regulation within the license renewal period.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Assignment of Hours of Approved Training.</text> <paragraph num="(1)"> <text>The Board shall assign hours of approved training to a license renewal if the licensee completed the hours of training during the license renewal period, unless an extension has been granted pursuant to Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>For licensees applying for renewal for the first time, the Board shall assign hours of approved training to the license renewal if the licensee completed training set forth under:</text> <paragraph num="(a)"> <text>§C(1)—(6) of this regulation after the date the initial license is issued; or</text> </paragraph> <paragraph num="(b)"> <text>§C(7) of this regulation during the license renewal period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within the license renewal period, credit may not be received for training that is substantially similar to another training as determined by the Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures.</text> <paragraph num="(1)"> <text>The sponsor of a training course or licensee may request of the Board approval of training on a form provided by the Board.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall maintain a list of all approved providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Pre-Approved Providers and Courses."> <paragraph num="A."> <text>Pre-Approved Providers.</text> <paragraph num="(1)"> <text>Pre-approved providers shall offer continuing education programs that meet the objectives set forth in Regulations .01A and C of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The following are pre-approved providers:</text> <paragraph num="(a)"> <text>National, regional, or State accredited academic institutions offering academic courses or programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01.01B(20);</text> </paragraph> <paragraph num="(b)"> <text>State regional, national, or international, environmental health specialist associations offering educational programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01.01B(20); and</text> </paragraph> <paragraph num="(c)"> <text>State, regional, national, or international non-environmental health specialist associations offering educational programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01.01B(20).</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall maintain a list of pre-approved providers [and pre-approved continuing education courses] on its website.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Extension of Time."> <paragraph num="A."> <text>The Board may grant an extension and conditionally renew a license for 6 months if the Board determines that:</text> <paragraph num="(1)"> <text>Failure to fulfill the continuing education requirements is a result of:</text> <paragraph num="(a)"> <text>Functional impairment or prolonged illness that has been diagnosed by a health care practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Mandatory military service or deployment;</text> </paragraph> <paragraph num="(c)"> <text>A prolonged absence from the United States;</text> </paragraph> <paragraph num="(d)"> <text>An officially declared disaster; or</text> </paragraph> <paragraph num="(e)"> <text>Financial hardship; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensee attempted to meet the requirements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee’s failure to obtain the required continuing education units on or before the end of the 6-month extension shall result in the licensee’s inability to practice as an environmental health specialist in the State.</text> </paragraph> <paragraph num="C."> <text>If a licensee cannot obtain the required continuing education units on or before the end of the 6-month extension, the licensee may submit an application for inactive status.</text> </paragraph> <paragraph num="D."> <text>A licensee’s failure to obtain the required continuing education units within the 6-month extension period or to submit an inactive status application shall result in the license being placed on non-renewed status.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reporting, Documenting, and Auditing Compliance with Continuing Education Requirements."> <paragraph num="A."> <text>A licensee shall attest whether the licensee has completed the required number of hours of approved training on a form provided by the Board as part of the application for renewal.</text> </paragraph> <paragraph num="B."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Audit a percentage of its licensees, to be selected by the Board, for completion of approved training each renewal period; and</text> </paragraph> <paragraph num="(2)"> <text>Send a notice of audit to all licensees to be audited.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensee subject to an audit shall provide documentation of completion of all required approved training as specified in §D of this regulation within 30 days of the date of the notice of audit.</text> </paragraph> <paragraph num="D."> <text>Required Documentation.</text> <paragraph num="(1)"> <text>A licensee shall provide to the Board a:</text> <paragraph num="(a)"> <text>Transcript for courses taken at an accredited educational institution; and</text> </paragraph> <paragraph num="(b)"> <text>Certificate of completion for the approved training.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a certificate of completion is not available, the licensee shall provide other documentation determined by the Board to be adequate, in light of the nature of the training, to establish that training was actually received by the licensee.</text> </paragraph> <paragraph num="(3)"> <text>Other documentation adequate to establish that training was actually received may include:</text> <paragraph num="(a)"> <text>Date, location, and proof of attendance;</text> </paragraph> <paragraph num="(b)"> <text>Names and credentials of the presenters;</text> </paragraph> <paragraph num="(c)"> <text>Agenda, learning objectives, and topics presented;</text> </paragraph> <paragraph num="(d)"> <text>An outline of the presentation; and</text> </paragraph> <paragraph num="(e)"> <text>Proof of presentations made.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A licensee shall submit any additional information requested by the Board to evaluate completion of continuing education requirements.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Continuing Education Record Retention.</text> <paragraph num="(1)"> <text>A licensee with an active license shall retain records documenting completion of continuing education requirements for 2 years after the licensing renewal date for which the report of continuing education was submitted to the Board.</text> </paragraph> <paragraph num="(2)"> <text>The documentation required in §E(1) of this regulation may be requested by the Board at any time within that 2-year period.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Failure to Comply with Continuing Education Requirements."> <paragraph num="A."> <text>A license will not be renewed if the licensee:</text> <paragraph num="(1)"> <text>Fails to attest on the renewal application that the licensee has completed the required number of hours of approved training; and</text> </paragraph> <paragraph num="(2)"> <text>Was not granted an extension from the Board pursuant to Regulation .03 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board may take disciplinary action against any licensee who, during an audit:</text> <paragraph num="(1)"> <text>Fails to submit the required documentation in accordance with Regulation .04 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Fails to demonstrate completion of the required hours of approved training in accordance with this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Falsifies or misrepresents any information concerning continuing education on a renewal application.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§21-101—21-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and.02 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 28, 2021 (48:13 Md. R. 508); May 1, 2023 (50:8 Md. R. 338)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C, E amended effective November 9, 2015 (42:22 Md. R. 1379); April 23, 2018 (45:8 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 9, 2015 (42:22 Md. R. 1379); June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective June 28, 2021 (48:13 Md. R. 508)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective April 23, 2018 (45:8 Md. R. 422)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective January 9, 2024 (51:3 Md. R. 153); emergency status expired July 7, 2024; chapter revised permanently effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="04" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary matters and hearings before the State Board of Environmental Health Specialists.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, in addition to the definitions set forth in COMAR 10.60.01.01, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means the hearing officer assigned to preside over a hearing in a case the Board has delegated to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board.</text> </paragraph> <paragraph num="(3)"> <text>“Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Environmental Health Specialists.</text> </paragraph> <paragraph num="(5)"> <text>“Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.</text> </paragraph> <paragraph num="(6)"> <text>“Case resolution conference committee” means a committee composed of one or more members of the Board that makes recommendations to the Board regarding settlement of disciplinary matters.</text> </paragraph> <paragraph num="(7)"> <text>“Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering:</text> <paragraph num="(a)"> <text>A licensee to cease a specified activity; or</text> </paragraph> <paragraph num="(b)"> <text>An unlicensed individual to cease the unauthorized practice of an environmental health specialist.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Charging document” means a nonpublic record issued by the Board which:</text> <paragraph num="(a)"> <text>Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Environmental Health Specialists Act;</text> </paragraph> <paragraph num="(b)"> <text>Sets forth provisions of the Maryland Environmental Health Specialists Act that the Board believes were violated; and</text> </paragraph> <paragraph num="(c)"> <text>Provides notice to the licensee of disciplinary proceedings before the Board.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Complaint” means a written allegation received by the Board that a licensee may have violated the Maryland Environmental Health Specialists Act and which may be grounds for an investigation or disciplinary action by the Board.</text> </paragraph> <paragraph num="(10)"> <text>“Consent order” means a public record issued by the Board that is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter.</text> </paragraph> <paragraph num="(11)"> <text>“Contested case” means a proceeding conducted under the Administrative Procedure Act.</text> </paragraph> <paragraph num="(12)"> <text>“Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which:</text> <paragraph num="(a)"> <text>Denies a license;</text> </paragraph> <paragraph num="(b)"> <text>Sanctions by reprimand, probation, fine, or suspension or revocation of a license;</text> </paragraph> <paragraph num="(c)"> <text>Summarily suspends a license;</text> </paragraph> <paragraph num="(d)"> <text>Dismisses charges;</text> </paragraph> <paragraph num="(e)"> <text>Surrenders a license; or</text> </paragraph> <paragraph num="(f)"> <text>Takes any other action that the Board may do by law.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Informal action” means that the Board closes a case without taking formal disciplinary action or without issuing a final order, by imposing a disciplinary sanction consisting of a:</text> <paragraph num="(a)"> <text>Letter of education;</text> </paragraph> <paragraph num="(b)"> <text>Letter of admonishment;</text> </paragraph> <paragraph num="(c)"> <text>Cease and desist letter; or</text> </paragraph> <paragraph num="(d)"> <text>Consent agreement.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Investigation” means the gathering of information to assist the Board in determining if there is reasonable cause to charge a licensee with a violation of the Maryland Environmental Health Specialists Act.</text> </paragraph> <paragraph num="(15)"> <text>Letter of Admonishment.</text> <paragraph num="(a)"> <text>“Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing a case, if the Board believes a licensee has engaged in conduct that violates the Maryland Environmental Health Specialists Act, admonishing the licensee not to repeat the conduct.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of admonishment” may include an agreement that the licensee perform certain conditions instead of the Board taking formal disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Letter of education” means informal action consisting of a nonpublic letter to a licensee:</text> <paragraph num="(a)"> <text>Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Environmental Health Specialist Act; and</text> </paragraph> <paragraph num="(b)"> <text>In which the Board educates the licensee concerning the laws and standards of the practice of environmental health work.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>Letter of Surrender.</text> <paragraph num="(a)"> <text>“Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the license to practice environmental health work.</text> </paragraph> <paragraph num="(b)"> <text>“Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Licensee” means an individual holding:</text> <paragraph num="(a)"> <text>An active license;</text> </paragraph> <paragraph num="(b)"> <text>A non-renewed license; or</text> </paragraph> <paragraph num="(c)"> <text>An inactive license.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Licensure” means permission to engage in the practice of environmental health work which is evidenced by a license issued by the Board.</text> </paragraph> <paragraph num="(20)"> <text>“Maryland Environmental Health Specialists Act” means Health Occupations Article, Title21, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(21)"> <text>“Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny:</text> <paragraph num="(a)"> <text>A license;</text> </paragraph> <paragraph num="(b)"> <text>A change in licensure status; or</text> </paragraph> <paragraph num="(c)"> <text>Another benefit sought by the licensee.</text> </paragraph> </paragraph> <paragraph num="(22)"> <text>“Postdeprivation evidentiary hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension.</text> </paragraph> <paragraph num="(23)"> <text>“Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why it should not:</text> <paragraph num="(a)"> <text>Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>Take some other action that the Board may by law take.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Preliminary review” means the gathering of information to be used by the Board to determine if the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Environmental Health Specialists Act.</text> </paragraph> <paragraph num="(25)"> <text>“Probation” means a sanction imposed by the Board in a public final order in which the licensee is:</text> <paragraph num="(a)"> <text>Monitored by the Board for a period of time; and</text> </paragraph> <paragraph num="(b)"> <text>Required to comply with certain conditions to avoid further disciplinary action.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(27)"> <text>“Recommended decision” means a nonpublic record issued to the Board by an administrative law judge that sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of them.</text> </paragraph> <paragraph num="(28)"> <text>“Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in a case.</text> </paragraph> <paragraph num="(29)"> <text>“Respondent” means a licensee, subject to the jurisdiction of the Board, that has been:</text> <paragraph num="(a)"> <text>Given notice to answer allegations concerning violations of the Maryland Environmental Health Specialists Act;</text> </paragraph> <paragraph num="(b)"> <text>Notified as to a potential emergency suspension under State Government Article, §10-226(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Notified as to potential violation of Health Occupations Article, §21-401, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“Revocation” means the removal of an environmental health specialist license to practice environmental health.</text> </paragraph> <paragraph num="(31)"> <text>“Sanction” means an action by the Board, including a:</text> <paragraph num="(a)"> <text>Reprimand;</text> </paragraph> <paragraph num="(b)"> <text>Placement on probation;</text> </paragraph> <paragraph num="(c)"> <text>Fine; or</text> </paragraph> <paragraph num="(d)"> <text>Suspension or revocation of a license.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Show cause hearing” means a nonevidentiary hearing before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board may take.</text> </paragraph> <paragraph num="(33)"> <text>“Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions.</text> </paragraph> <paragraph num="(34)"> <text>“Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, taken if the Board believes the action is necessary to protect the public health, safety, or welfare.</text> </paragraph> <paragraph num="(35)"> <text>“Surrender” means the voluntary relinquishing of a license to practice environmental health specialist that may be subject to certain conditions set by the Board.</text> </paragraph> <paragraph num="(36)"> <text>“Suspension” means a temporary denial of the right to use a license and is usually defined by:</text> <paragraph num="(a)"> <text>A specific period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specific dates; or</text> </paragraph> <paragraph num="(c)"> <text>Specific conditions.</text> </paragraph> </paragraph> <paragraph num="(37)"> <text>“Violation” means an act or omission prohibited under Health Occupations Article, §21-312, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Proceedings."> <paragraph num="A."> <text>Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this regulation.</text> </paragraph> <paragraph num="B."> <text>The Office of Administrative Hearings' proceedings involving the adjudication of a Board-contested case and the administrative law judge's recommended decision are confidential. The respondent may not waive the confidentiality of the proceedings or of the clients whose medical records or care are reflected in the record of the proceedings.</text> </paragraph> <paragraph num="C."> <text>To the extent possible, even after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any clients referred to in the Board's order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Representation by Counsel."> <paragraph num="A."> <text>A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>If the matter goes to a hearing, the respondent shall be represented in proper person or by an attorney who has been admitted to the Maryland Bar or specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>In all proceedings, the Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Proceedings under Health Occupations Article, §21-312, Annotated Code of Maryland."> <paragraph num="A."> <text>Investigation of Complaints.</text> <paragraph num="(1)"> <text>The Board may:</text> <paragraph num="(a)"> <text>Make a preliminary review of each complaint; and</text> </paragraph> <paragraph num="(b)"> <text>Recommend that cases involving complaints over which the Board lacks jurisdiction be closed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee that is the subject of the complaint, to obtain a response to the allegations made in the complaint.</text> </paragraph> <paragraph num="(3)"> <text>Board subpoenas may be issued by the Board over the signature of an officer or the administrator.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prosecution of Complaint.</text> <paragraph num="(1)"> <text>After reviewing any completed investigative information or reports for each complaint, the Board shall:</text> <paragraph num="(a)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(b)"> <text>Close the case with informal action;</text> </paragraph> <paragraph num="(c)"> <text>Issue a cease and desist order;</text> </paragraph> <paragraph num="(d)"> <text>Refer the matter for further investigation;</text> </paragraph> <paragraph num="(e)"> <text>Refer the matter to an administrative prosecutor; or</text> </paragraph> <paragraph num="(f)"> <text>Vote to:</text> <paragraph num="(i)"> <text>Charge a licensee with a violation of Health Occupations Article, §21-312, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(iii)"> <text>Initially deny licensure or reinstatement of a license; or</text> </paragraph> <paragraph num="(iv)"> <text>Accept the surrender of a license subject to conditions acceptable to the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether it has voted to charge a licensee with violations of the Maryland Environmental Health Specialist Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Charges and Notice of Initial Denial.</text> <paragraph num="(1)"> <text>If the Board issues charges or a notice of initial denial, the document shall be:</text> <paragraph num="(a)"> <text>Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board;</text> </paragraph> <paragraph num="(b)"> <text>Hand-delivered in person; or</text> </paragraph> <paragraph num="(c)"> <text>Served by other means reasonable to effect service.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Charges or a notice of initial denial shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory basis for the charges or denial of licensure;</text> </paragraph> <paragraph num="(b)"> <text>Allege sufficient facts which the Board believes constitute either a basis for:</text> <paragraph num="(i)"> <text>Violation of the Maryland Environmental Health Specialists Act; or</text> </paragraph> <paragraph num="(ii)"> <text>Denial of licensure;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or failing to request a hearing; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation, the Board may nevertheless proceed in prosecuting the case.</text> </paragraph> <paragraph num="(4)"> <text>If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Discovery.</text> <paragraph num="(1)"> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(a)"> <text>A list of the witnesses to be called;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Both §D1(a) and (b) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mandatory Discovery.</text> <paragraph num="(a)"> <text>Each party shall provide to the other party, not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(i)"> <text>The name and curriculum vitae of any expert witness that will testify at the hearing; and</text> </paragraph> <paragraph num="(ii)"> <text>A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §D(2)(a) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.</text> </paragraph> <paragraph num="(c)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments on the sufficiency of the report:</text> <paragraph num="(i)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(ii)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §D(2)(a)(ii) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(4)"> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="(5)"> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after:</text> <paragraph num="(a)"> <text>The prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="(7)"> <text>Construction.</text> <paragraph num="(a)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(b)"> <text>In a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Case Resolution Conference.</text> <paragraph num="(1)"> <text>After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference.</text> </paragraph> <paragraph num="(2)"> <text>At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter.</text> </paragraph> <paragraph num="(3)"> <text>Except as provided in Regulation .05E(1) of this chapter, the Board may deny a respondent's request for a case resolution conference.</text> </paragraph> <paragraph num="(4)"> <text>Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source.</text> </paragraph> <paragraph num="(5)"> <text>Recommendations of the case resolution conference are not binding on the Board, which may:</text> <paragraph num="(a)"> <text>Modify a proposed settlement;</text> </paragraph> <paragraph num="(b)"> <text>Require additional conditions; or</text> </paragraph> <paragraph num="(c)"> <text>Reject the recommendation and require the respondent to proceed to a hearing.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial.</text> </paragraph> <paragraph num="(7)"> <text>If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.</text> </paragraph> <paragraph num="(8)"> <text>Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Sanctions, Hearings, and Final Order."> <paragraph num="A."> <text>Surrender of License.</text> <paragraph num="(1)"> <text>The Board may require conditions for surrender of a license, including:</text> <paragraph num="(a)"> <text>An admission of a violation of the Maryland Environmental Health Specialists Act;</text> </paragraph> <paragraph num="(b)"> <text>An admission of facts;</text> </paragraph> <paragraph num="(c)"> <text>A statement of the circumstances under which the surrender was offered or accepted;</text> </paragraph> <paragraph num="(d)"> <text>Restrictions on future licensure;</text> </paragraph> <paragraph num="(e)"> <text>Conditions for reinstatement of the license; or</text> </paragraph> <paragraph num="(f)"> <text>An agreement that the respondent may not apply for reinstatement of the license.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the Board determines that disclosure of the surrender is not in the public interest, a letter of surrender is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearings on Charges or Notice of Initial Denial.</text> <paragraph num="(1)"> <text>Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>Proceedings may not be open to the public.</text> </paragraph> <paragraph num="(4)"> <text>All records, including the recommended decision, shall be confidential and sealed.</text> </paragraph> <paragraph num="(5)"> <text>If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed sanction; or</text> </paragraph> <paragraph num="(d)"> <text>A combination of §B(5)(a)—(c) of this regulation pursuant to the Board's delegation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Burden of Proof.</text> <paragraph num="(1)"> <text>A licensee to whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied.</text> </paragraph> <paragraph num="(2)"> <text>The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Environmental Health Specialists Act.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions and Exceptions Hearing.</text> <paragraph num="(1)"> <text>If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision.</text> </paragraph> <paragraph num="(2)"> <text>Unless otherwise permitted by the Board, within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages, and shall state with particularity the finding of fact, conclusion of law, or other matter excepted to, and the relevant portions of the record supporting the party's exception.</text> </paragraph> <paragraph num="(4)"> <text>Unless otherwise permitted by the Board, within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions.</text> </paragraph> <paragraph num="(5)"> <text>Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response.</text> </paragraph> <paragraph num="(6)"> <text>Unless otherwise permitted, the Board may not consider a party's response to an answer to the exceptions.</text> </paragraph> <paragraph num="(7)"> <text>Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties' exceptions and any answer to exceptions.</text> </paragraph> <paragraph num="(8)"> <text>Exceptions Hearing.</text> <paragraph num="(a)"> <text>An exceptions hearing shall be held before the Board.</text> </paragraph> <paragraph num="(b)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions.</text> </paragraph> <paragraph num="(c)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(d)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient progress of the hearing.</text> </paragraph> <paragraph num="(e)"> <text>The respondent and the administrative prosecutor each may not exceed 30 minutes to present oral argument.</text> </paragraph> <paragraph num="(f)"> <text>The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in an answer to exceptions or in the hearing on exceptions, reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge.</text> </paragraph> <paragraph num="(10)"> <text>If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Board Final Decision and Order.</text> <paragraph num="(1)"> <text>After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed.</text> </paragraph> <paragraph num="(2)"> <text>Upon a finding that there has been a violation of the Maryland Environmental Health Specialists Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a License."> <paragraph num="A."> <text>Pursuant to its authority under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare.</text> </paragraph> <paragraph num="B."> <text>Notice of Intent to Summarily Suspend.</text> <paragraph num="(1)"> <text>Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:</text> <paragraph num="(a)"> <text>A notice of intent to summarily suspend a license; or</text> </paragraph> <paragraph num="(b)"> <text>An order of summary suspension.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board votes to issue a notice of intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.</text> </paragraph> <paragraph num="(3)"> <text>A notice of intent to summarily suspend a license shall include:</text> <paragraph num="(a)"> <text>A proposed order of summary suspension which is unexecuted by the Board and includes:</text> <paragraph num="(i)"> <text>The statutory authority on which the action has been taken;</text> </paragraph> <paragraph num="(ii)"> <text>Allegations of fact that the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and</text> </paragraph> <paragraph num="(iii)"> <text>Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Service.</text> <paragraph num="(a)"> <text>The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board.</text> </paragraph> <paragraph num="(b)"> <text>Service of the notice of intent to summarily suspend shall be made:</text> <paragraph num="(i)"> <text>Personally upon the respondent;</text> </paragraph> <paragraph num="(ii)"> <text>By certified mail to the address the respondent is required to maintain with the Board; or</text> </paragraph> <paragraph num="(iii)"> <text>By other reasonable means to effect service.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed to prosecute the case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Predeprivation Opportunity to Be Heard.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension.</text> </paragraph> <paragraph num="(2)"> <text>Predeprivation Show Cause Hearing Before the Board.</text> <paragraph num="(a)"> <text>The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.</text> </paragraph> <paragraph num="(b)"> <text>The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument.</text> </paragraph> <paragraph num="(c)"> <text>The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing.</text> </paragraph> <paragraph num="(d)"> <text>The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument.</text> </paragraph> <paragraph num="(e)"> <text>The respondent shall proceed first and may reserve part of the allotted time for rebuttal.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Board member who presides over the hearing:</text> <paragraph num="(a)"> <text>May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not duly repetitious, if the presiding Board member believes that such documents or exhibits are necessary for a fair hearing; and</text> </paragraph> <paragraph num="(b)"> <text>May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Summary Suspension Without Prior Notice or Hearing Opportunity.</text> <paragraph num="(1)"> <text>Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend license or providing a respondent with an opportunity for a predeprivation hearing if the Board determines that:</text> <paragraph num="(a)"> <text>The public health, safety, and welfare require the immediate suspension of the license; and</text> </paragraph> <paragraph num="(b)"> <text>Prior notice and an opportunity to be heard are not feasible.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Time—Service and Hearing.</text> <paragraph num="(a)"> <text>An order of summary suspension under §D(1) of this regulation shall be served upon the respondent within 24 hours after its execution.</text> </paragraph> <paragraph num="(b)"> <text>The respondent shall be provided an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall:</text> <paragraph num="(a)"> <text>Be conducted before the Board as provided in §D(2)(b) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Burdens of Production and Persuasion.</text> <paragraph num="(1)"> <text>In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk.</text> </paragraph> <paragraph num="(2)"> <text>The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Disposition.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to:</text> <paragraph num="(a)"> <text>Order a summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Deny the summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to:</text> <paragraph num="(a)"> <text>Affirm its order of summary suspension;</text> </paragraph> <paragraph num="(b)"> <text>Rescind the order for summary suspension;</text> </paragraph> <paragraph num="(c)"> <text>Issue an order agreed upon by the parties; or</text> </paragraph> <paragraph num="(d)"> <text>Issue an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Postdeprivation Opportunity for an Evidentiary Hearing.</text> <paragraph num="(1)"> <text>If the Board orders the summary suspension of a license under §C or D of this regulation, the respondent shall be provided with an opportunity for an evidentiary hearing before the Board, or if the Board delegates the matter to the Office of Administrative Hearings, before an administrative law judge.</text> </paragraph> <paragraph num="(2)"> <text>The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension.</text> </paragraph> <paragraph num="(3)"> <text>Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after respondent's request.</text> </paragraph> <paragraph num="(4)"> <text>An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension.</text> </paragraph> <paragraph num="(5)"> <text>An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>If the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge shall issue a recommended decision to the Board with:</text> <paragraph num="(a)"> <text>Proposed or final findings of fact;</text> </paragraph> <paragraph num="(b)"> <text>Proposed or final conclusions of law;</text> </paragraph> <paragraph num="(c)"> <text>A proposed disposition; or</text> </paragraph> <paragraph num="(d)"> <text>Any combination of §G(6)(a)—(c) of this regulation, pursuant to the Board's delegation of the matter to the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the hearing is one combined with charges, the administrative law judge's determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension.</text> </paragraph> <paragraph num="(8)"> <text>The parties may file exceptions to the recommended decision, as provided in the State Government Article, §10-216, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>An order issued by the Board after a postdeprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Probation and Violation of Probation Proceedings."> <paragraph num="A."> <text>If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board considers appropriate, including:</text> <paragraph num="(1)"> <text>Reeducation or completion of approved courses;</text> </paragraph> <paragraph num="(2)"> <text>Payment of a fine;</text> </paragraph> <paragraph num="(3)"> <text>Providing free environmental health specialist services in a Board-approved program;</text> </paragraph> <paragraph num="(4)"> <text>Practicing under supervision;</text> </paragraph> <paragraph num="(5)"> <text>Monitoring by the Board or by an individual or entity approved by the Board, with periodic reporting to the Board;</text> </paragraph> <paragraph num="(6)"> <text>Periodic review of a licensee's practices or billing;</text> </paragraph> <paragraph num="(7)"> <text>Periodic audits of a licensee's billing practices;</text> </paragraph> <paragraph num="(8)"> <text>An examination by a physician or other appropriate health care provider;</text> </paragraph> <paragraph num="(9)"> <text>Limitation of the licensee's practice;</text> </paragraph> <paragraph num="(10)"> <text>Obtaining a passing score on an appropriate examination; or</text> </paragraph> <paragraph num="(11)"> <text>Any other condition the Board considers appropriate for the rehabilitation or retraining of a licensee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee.</text> </paragraph> <paragraph num="C."> <text>A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when:</text> <paragraph num="(1)"> <text>The specific period of time has passed; or</text> </paragraph> <paragraph num="(2)"> <text>The licensee has successfully completed the conditions or acts required for termination.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall:</text> <paragraph num="(1)"> <text>Charge the licensee with a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Take any action the final order or consent order provides for a violation of probation, including suspension of the license;</text> </paragraph> <paragraph num="(3)"> <text>Consider a summary suspension of the license; or</text> </paragraph> <paragraph num="(4)"> <text>Take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Charges for Violation of Probation.</text> <paragraph num="(1)"> <text>If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The charging document for a violation of probation shall:</text> <paragraph num="(a)"> <text>Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated;</text> </paragraph> <paragraph num="(b)"> <text>Allege facts that constitute a basis for a violation of probation; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for those proceedings or failing to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .05E of this chapter.</text> </paragraph> <paragraph num="G."> <text>If the Board determines that a respondent has violated probation, the Board shall:</text> <paragraph num="(1)"> <text>Take any action the consent order or final order provides for a violation of probation;</text> </paragraph> <paragraph num="(2)"> <text>Impose additional conditions of probation; or</text> </paragraph> <paragraph num="(3)"> <text>Impose a sanction or take any other action the Board considers appropriate and may take by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Right of Appeal."> <paragraph num="A."> <text>An individual whose certificate has been revoked or suspended by the Board, or an individual placed on probation or reprimand under the regulations in this chapter, may appeal the Board’s decision as provided by the law.</text> </paragraph> <paragraph num="B."> <text>A licensee or certificate holder shall pay to the Board a penalty imposed under this chapter as of the date the Board’s order is issued, unless the Board’s order specifies otherwise.</text> </paragraph> <paragraph num="C."> <text>Filing an appeal under State Government Article, §10–222, Annotated Code of Maryland, or Health Occupations Article, §21–314, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter.</text> </paragraph> <paragraph num="D."> <text>If a licensee or certificate holder fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may, in its discretion, restore, reinstate, or renew a license until the penalty has been paid in full.</text> </paragraph> <paragraph num="E."> <text>In its discretion, the Board may refer all cases of delinquent payment to the Central Collections Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.</text> </paragraph> <paragraph num="F."> <text>The Board shall pay all monies collected under this chapter into the State’s General Fund.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Restoration of a License."> <paragraph num="A."> <text>Reinstatement.</text> <paragraph num="(1)"> <text>A licensee shall petition the Board for a termination of a suspension of a license or a reinstatement after revocation or surrender of a license.</text> </paragraph> <paragraph num="(2)"> <text>A licensee that petitions the Board for reinstatement under the terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board, shall apply for reinstatement only under those terms and conditions.</text> </paragraph> <paragraph num="(3)"> <text>A licensee whose license has been revoked or surrendered for 5 or more years before filing a petition for reinstatement is ineligible for reinstatement but may apply for initial licensure.</text> </paragraph> <paragraph num="(4)"> <text>In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall:</text> <paragraph num="(a)"> <text>File an application for reinstatement with the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Meet the requirements for reinstatement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Intent to Deny Reinstatement and Hearing Opportunity.</text> <paragraph num="(1)"> <text>If the Board issues a notice of intent to deny reinstatement, that notice shall be served as provided for in Regulation .05C(1) and (3) of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>A notice of intent to deny reinstatement shall:</text> <paragraph num="(a)"> <text>Inform the applicant of the legal basis for the Board's belief that the applicant is not qualified for reinstatement, including any applicable statutory provision;</text> </paragraph> <paragraph num="(b)"> <text>Allege any facts the Board believes support the Board's reasons for denying reinstatement; and</text> </paragraph> <paragraph num="(c)"> <text>Notify the respondent of:</text> <paragraph num="(i)"> <text>Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and</text> </paragraph> <paragraph num="(ii)"> <text>The consequences of failing to appear for scheduled proceedings or to request a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference as provided in Regulation .06A of this chapter, to discuss settlement of the matter.</text> </paragraph> <paragraph num="(4)"> <text>A hearing on the notice of denial of reinstatement shall be held before the Board or a delegated to an administrative law judge and conducted under the contested case provisions of the Administrative Procedure Act.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Board grants reinstatement of a license, it may impose any restrictions or conditions on the license or the licensee's practice that it considers appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Judicial Review."> <text>A final order of the Board is subject to judicial review as provided in Health Occupations Article, §21-314 and State Government Article, §10-222, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Fines."> <paragraph num="A."> <text>This regulation establishes the standards by which the Board may impose a fine not exceeding $5,000.</text> </paragraph> <paragraph num="B."> <text>After a hearing under Health Occupations Article, §21-313, Annotated Code of Maryland, and COMAR 10.60.04, the Board may impose a fine, in addition to, or instead of:</text> <paragraph num="(1)"> <text>Reprimanding a licensee;</text> </paragraph> <paragraph num="(2)"> <text>Placing a licensee on probation; or</text> </paragraph> <paragraph num="(3)"> <text>Suspending or revoking a license.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In determining whether to impose a fine and the amount of the fine, the Board shall consider the following factors:</text> <paragraph num="(1)"> <text>The cost of investigating and prosecuting the case against the individual;</text> </paragraph> <paragraph num="(2)"> <text>The extent of actual or potential public harm caused by the violation;</text> </paragraph> <paragraph num="(3)"> <text>The extent to which the individual derived a financial benefit from the violation;</text> </paragraph> <paragraph num="(4)"> <text>The history of a previous violation or violations;</text> </paragraph> <paragraph num="(5)"> <text>The willfulness of the improper conduct; and</text> </paragraph> <paragraph num="(6)"> <text>Mitigating factors as presented by the licensee.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An individual shall pay the fine to the Board under the terms of the Board's order.</text> </paragraph> <paragraph num="E."> <text>The Board shall pay all monies collected under this chapter to the General Fund of the State.</text> </paragraph> <paragraph num="F."> <text>Unless the Board's order provides otherwise, if an individual fails to pay, in whole or in part, a fine imposed by the Board, the Board may not restore, reinstate, or renew the license of the individual until the individual pays the fine in full.</text> </paragraph> <paragraph num="G."> <text>The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Cost Recovery."> <text>If after a hearing, a licensee is found to have violated any of the provisions of Health Occupations Article, §21-312, Annotated Code of Maryland, the Board shall be entitled to reimbursement of costs by the licensee including any or all of the following items:</text> <paragraph num="A."> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="B."> <text>Transcription of the hearing record by court reporters;</text> </paragraph> <paragraph num="C."> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="D."> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="E."> <text>Hearing-related per diems and expenses for Board members; and</text> </paragraph> <paragraph num="F."> <text>Other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§21-205, 21-312—21-315, and 21-401; State Government Article, §§10-201—10-226; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.12 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective March 13, 2017 (44:5 Md. R. 294)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 28, 2021 (48:13 Md. R. 508)</annotation> </annotations> </chapter> <chapter num="05" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>An applicant for a license as an environmental health specialist or a licensee shall:</text> <paragraph num="A."> <text>Protect and promote the health and safety of the public and the environment through the advancement of public and environmental health; and</text> </paragraph> <paragraph num="B."> <text>Promote environmental health and the related professions through experience and continuing education training.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Unethical Conduct."> <text>It is unethical for an applicant for a license as an environmental health specialist or a licensee to:</text> <paragraph num="A."> <text>Engage in conduct prohibited by Health Occupations Article, §§1-212 and 21-312, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Where applicable, engage in conduct prohibited by State Public Ethics Law, State Government Article, §§15-501 — 15-509, Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>Where applicable, engage in conduct prohibited by a county or municipal ethics law adopted pursuant to State Government Article, Title 15, Subtitle 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="D."> <text>Refuse a professional service based on race, creed, color, or national origin;</text> </paragraph> <paragraph num="E."> <text>Willfully disregard any observed, known, or continued violation of any federal, State, or local law or regulation regarding public or environmental health;</text> </paragraph> <paragraph num="F."> <text>Falsify or misrepresent any qualifications or information required to be set forth in any application for licensure or other submission to the board required under Health Occupations or Health General Articles, Annotated Code of Maryland;</text> </paragraph> <paragraph num="G."> <text>Knowingly become involved in an actual or perceived conflict of interest unless:</text> <paragraph num="(1)"> <text>The conflict can be legally waived; and</text> </paragraph> <paragraph num="(2)"> <text>Waiver is obtained in writing from all affected parties;</text> </paragraph> </paragraph> <paragraph num="H."> <text>If a conflict of interest arises, fail to disclose the conflict of interest to all affected parties;</text> </paragraph> <paragraph num="I."> <text>Accept gifts or gratuities in exchange for preferential regulatory treatment;</text> </paragraph> <paragraph num="J."> <text>Offer gifts or gratuities to a regulatory authority with expectation of preferential regulatory treatment; and</text> </paragraph> <paragraph num="K."> <text>Disclose confidences or other proprietary information.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 21-312, and 21-205, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and.02 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> </annotations> </chapter> <chapter num="06" heading="Fee Schedule"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs an individual licensed as Environmental Health Specialist in the State.</text> </paragraph> <paragraph num="B."> <text>All fees are nonrefundable.</text> </paragraph> <paragraph num="C."> <text>The examination fee is the cost as established by the examination service.</text> </paragraph> <paragraph num="D."> <text>The following fees apply:</text> <paragraph num="(1)"> <text>Application processing fee — $100;</text> </paragraph> <paragraph num="(2)"> <text>12-month renewal of certificate of eligibility for obtaining employment — $50;</text> </paragraph> <paragraph num="(3)"> <text>Initial license fee — $75;</text> </paragraph> <paragraph num="(4)"> <text>Biennial license renewal — $200;</text> </paragraph> <paragraph num="(5)"> <text>One-time renewal fee for licenses expiring on June 30, 2023 for licensees with an even-numbered birth year whose license will be renewed for 1 year — $100;</text> </paragraph> <paragraph num="(6)"> <text>Reactivation processing fee to change from inactive status to active status — $300;</text> </paragraph> <paragraph num="(7)"> <text>Reactivation processing fee to change from non-renewed status to active status — $500;</text> </paragraph> <paragraph num="(8)"> <text>Inactive status fee — $25;</text> </paragraph> <paragraph num="(9)"> <text>Returned check charge (plus bank charges) — $25;</text> </paragraph> <paragraph num="(10)"> <text>Replacement of license — $25;</text> </paragraph> <paragraph num="(11)"> <text>Copy of roster of current license holders — $25; and</text> </paragraph> <paragraph num="(12)"> <text>24-month renewal of certificate of in training for temporary employee — $25..</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§21-205, 21-206, and 21-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective November 9, 2015 (42:22 Md. R. 1379); March 13, 2017 (44:5 Md. R. 294), May 1, 2023 (50:8 Md. R. 338)</annotation> </annotations> </chapter> <chapter num="07" heading="Compelling Public Purpose Disclosure"> <regulation prefix="Regulation" num=".01" heading="Disclosure for Compelling Public Purpose."> <text>The custodian of the records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, and may disclose the information if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to that information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual which the custodian of the records reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Other Disclosures."> <text>This chapter does not prohibit or limit the ability of the Board to disclose general licensing information under General Provisions Article, §4-333, Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333; Health Occupations Article, §21-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 adopted as an emergency provision effective January 3, 2013 (40:6 Md. R. 469); adopted permanently effective April 15, 2013 (40:7 Md. R. 612)</annotation> </annotations> </chapter> </subtitle> <subtitle num="61" heading="Health Enterprise Zone Initiative"> <chapter num="01" heading="Health Enterprise Zone Tax Credits"> <regulation prefix="Regulation" num=".01" heading="Objective."> <text>The objective of the Health Enterprise Zone tax credits are to reduce health disparities, improve health outcomes, and reduce health care costs and hospital admissions and readmissions in traditionally underserved communities in the State by encouraging qualified licensed or certified health care practitioners to relocate or expand services in areas designated as Health Enterprise Zones under the Maryland Health Improvement and Disparities Reduction Act of 2012, Health-General Article, §20-1401, et seq., Annotated Code of Maryland, and Tax-General Article, §10-731, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Purpose."> <text>This chapter describes the procedures that will be used by the Secretary of Health to establish the requirements necessary to qualify for and receive the Health Enterprise Zone tax credits.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Credit year” means the taxable year for which a qualified Health Enterprise Zone practitioner claims a Health Enterprise Zone tax credit.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Health Enterprise Zone” has the meaning stated in Health-General Article, §20-1401(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Health Enterprise Zone employer” means a Health Enterprise Zone practitioner, a for-profit entity, or a nonprofit entity that employs qualified employees and provides health care services in a Health Enterprise Zone.</text> </paragraph> <paragraph num="(5)"> <text>“Health Enterprise Zone practitioner” means a health care practitioner who:</text> <paragraph num="(a)"> <text>Is licensed or certified under the Health Occupations Article; and</text> </paragraph> <paragraph num="(b)"> <text>Provides one or more of the following services in a Health Enterprise Zone:</text> <paragraph num="(i)"> <text>Primary care, including obstetrics, gynecological services, pediatric services, or geriatric services;</text> </paragraph> <paragraph num="(ii)"> <text>Behavioral health services, including mental health or alcohol and substance abuse services; or</text> </paragraph> <paragraph num="(iii)"> <text>Dental services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Hiring tax credit” means the Health Enterprise Zone tax credit set forth under Tax-General Article, §10-731(d)(2), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Income tax credit” means the Health Enterprise Zone tax credit set forth under Tax-General Article, §10-731(d)(1), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Qualified employee” means a Health Enterprise Zone practitioner, community health worker, or interpreter who:</text> <paragraph num="(a)"> <text>Provides direct support to a Health Enterprise Zone practitioner; and</text> </paragraph> <paragraph num="(b)"> <text>Expands access to services in a Health Enterprise Zone.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Qualified Position.</text> <paragraph num="(a)"> <text>“Qualified position” means a qualified employee position that:</text> <paragraph num="(i)"> <text>Pays at least 150 percent of the federal minimum wage;</text> </paragraph> <paragraph num="(ii)"> <text>Is full-time and of indefinite duration;</text> </paragraph> <paragraph num="(iii)"> <text>Is located in a Health Enterprise Zone;</text> </paragraph> <paragraph num="(iv)"> <text>Is newly created as a result of the establishment of, or expansion of services in, a Health Enterprise Zone; and</text> </paragraph> <paragraph num="(v)"> <text>Is filled.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Qualified position” does not include a position that is filled for a period of less than 12 months.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Income Tax Credits."> <paragraph num="A."> <text>The income tax credit is a nonrefundable credit against the State income tax and shall be in an amount equal to 100 percent of the amount of State income tax expected to be due from the Health Enterprise Zone practitioner from income derived from practice in the Health Enterprise Zone for the credit year.</text> </paragraph> <paragraph num="B."> <text>A Health Enterprise Zone practitioner who practices health care in a Health Enterprise Zone may be eligible for an income tax credit available under Tax-General Article, §10-731, Annotated Code of Maryland, if the individual:</text> <paragraph num="(1)"> <text>Demonstrates cultural and linguistic competency in the form and manner set by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates competence in health literacy in the form and manner set by the Department;</text> </paragraph> <paragraph num="(3)"> <text>Demonstrates that the practitioner accepts and provides care for patients enrolled in the Maryland Medical Assistance Program and for uninsured patients in the form and manner required by the Department;</text> </paragraph> <paragraph num="(4)"> <text>Demonstrates support from the Health Enterprise Zone in which the HEZ practitioner is practicing in the form and manner specified by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Meets any other criteria specified in applicable tax forms by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certification for Income Tax Credit.</text> <paragraph num="(1)"> <text>To be certified as preliminarily eligible to receive the income tax credit, a Health Enterprise Zone practitioner shall submit an application for preliminary certification to the Department on a form approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>To receive final certification of eligibility to receive the Health Enterprise Zone Income tax credit, a Health Enterprise Zone practitioner shall:</text> <paragraph num="(a)"> <text>Have received preliminary certification; and</text> </paragraph> <paragraph num="(b)"> <text>Submit an application for final certification to the Department on a form approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To claim the credit, the HEZ practitioner shall file an amended tax return for the year in which the income was earned and attach a copy of the Department’s certification to the amended income tax return to claim the income tax credit.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Verification and Audit of Income Tax Credits and Hiring Tax Credits."> <paragraph num="A."> <text>The Department may:</text> <paragraph num="(1)"> <text>Request from an HEZ practitioner or employer additional information to verify statements in preliminary and final applications for the income tax credit and the hiring tax credit; and</text> </paragraph> <paragraph num="(2)"> <text>Use independent verification to verify information reported on a preliminary or final application for an income tax credit or a hiring tax credit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Comptroller retains its audit authority under Tax-General Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Hiring Tax Credits."> <paragraph num="A."> <text>The hiring tax credit is a refundable credit of $10,000 against the State income tax for hiring for a qualified position in a Health Enterprise Zone by a Health Enterprise Zone employer.</text> </paragraph> <paragraph num="B."> <text>A Health Enterprise Zone employer may be eligible for a hiring tax credit available under Tax-General Article, §10-731, Annotated Code of Maryland, if the Health Enterprise Zone employer:</text> <paragraph num="(1)"> <text>Creates one or more qualified positions during any 24-month period;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates support from the Health Enterprise Zone in which the Health Enterprise Zone employer is operating in the form and manner specified by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>Meets any other criteria specified in applicable tax forms by the Department.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Certification for Hiring Tax Credit.</text> <paragraph num="(1)"> <text>To be certified as preliminarily eligible to receive the hiring tax credit, a Health Enterprise Zone employer shall submit an application for preliminary certification to the Department on a form approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>To receive final certification of eligibility to receive the hiring tax credit, a Health Enterprise Zone employer shall:</text> <paragraph num="(a)"> <text>Have received preliminary certification; and</text> </paragraph> <paragraph num="(b)"> <text>Submit an application for final certification to the Department on a form approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To claim the hiring tax credit, the Health Enterprise Zone employer shall:</text> <paragraph num="(a)"> <text>Claim the credit on an electronically filed original or amended Maryland income tax return;</text> </paragraph> <paragraph num="(b)"> <text>Include a copy of the final certification from the Department with the electronic return as a binary attachment; and</text> </paragraph> <paragraph num="(c)"> <text>Meet any other criteria specified in applicable tax forms by the Comptroller.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Conditions on Hiring Tax Credit.</text> <paragraph num="(1)"> <text>The hiring tax credit shall be taken over a 24-month period, with 1/2 for the credit amount allowed each year beginning with the first taxable year in which the credit is certified.</text> </paragraph> <paragraph num="(2)"> <text>If the qualified position is filled for a period of less than 24 months, the hiring tax credit shall be recaptured as set forth under Tax-General Article, §10-731(d)(2)(iv), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 20, Subtitle 14; Tax-General Article, §10-731; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision effective January 13, 2014 (41:3 Md. R. 200); adopted permanently effective April 28, 2014 (41:8 Md. R. 473)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 22, 2014 (41:25 Md. R. 1485)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective December 22, 2014 (41:25 Md. R. 1485)</annotation> </annotations> </chapter> </subtitle> <subtitle num="62" heading="Natalie M. Laprade Medical Cannabis Commission"> <chapter num="01—37" heading="" reason="Repealed effective July 22, 2024 (Md. R. 51:14 678)" /> </subtitle> <subtitle num="63" heading="Community-Based Behavioral Health Programs and Services"> <chapter num="01" heading="Requirements for All Licensed Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the definitions for this subtitle and the requirement that a program be licensed to provide community behavioral health treatment, care, or rehabilitation services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation” means the approval granted by an approved accreditation organization of a provider, or the process of obtaining the approval.</text> </paragraph> <paragraph num="(2)"> <text>“Accreditation-based license” means a license that, in accordance with COMAR 10.63.02, may be issued or received only if the provider is accredited by an approved accreditation organization.</text> </paragraph> <paragraph num="(3)"> <text>“Administration” means the Behavioral Health Administration within the Maryland Department of Health.</text> </paragraph> <paragraph num="(4)"> <text>“Administrative services organization (ASO)” means the entity under contract with the Department to provide administrative services for the public behavioral health system.</text> </paragraph> <paragraph num="(5)"> <text>“Agreement to cooperate” means a written agreement between the program and a core service agency, local addictions authority, or local behavioral health authority that provides for coordination and cooperation in carrying out behavioral health activities in a given jurisdiction.</text> </paragraph> <paragraph num="(6)"> <text>“American Society of Addiction Medicine (ASAM) Criteria” means an instrument designed to indicate placement guidelines for admission, continued stay, and discharge of individuals with a substance-related disorder.</text> </paragraph> <paragraph num="(7)"> <text>“Approval” means the authorization issued on behalf of the former Maryland Mental Hygiene Administration to mental health providers to receive State funding for their services.</text> </paragraph> <paragraph num="(8)"> <text>“Approved accreditation organization” means an entity approved by the Secretary or the Secretary’s designee, under Health-General Article, §19-2302, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.</text> </paragraph> <paragraph num="(10)"> <text>“Behavioral health program” means:</text> <paragraph num="(a)"> <text>A substance-related disorders program;</text> </paragraph> <paragraph num="(b)"> <text>A mental health disorders program;</text> </paragraph> <paragraph num="(c)"> <text>An addictive disorder program; or</text> </paragraph> <paragraph num="(d)"> <text>A program that consists of a combination of disorder programs listed above.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Board” means the executive authority and policy-making group that oversees the operation of a behavioral health program.</text> </paragraph> <paragraph num="(12)"> <text>“Case resolution conference” means an informal proceeding that may take place before an evidentiary hearing to determine if there are grounds for settlement of a contested case.</text> </paragraph> <paragraph num="(13)"> <text>“Certification” means, unless otherwise specifically stated, the approval issued by the former Maryland Alcohol and Drug Abuse Administration authorizing substance use disorder treatment programs to operate in Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Community-based” means the setting of a program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>“Completed application” means that:</text> <paragraph num="(a)"> <text>All questions on the application form are answered;</text> </paragraph> <paragraph num="(b)"> <text>All necessary documents are included; and</text> </paragraph> <paragraph num="(c)"> <text>The application form has been signed by the applicant.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Consultant” means a professional who:</text> <paragraph num="(a)"> <text>Is not a salaried employee of the program;</text> </paragraph> <paragraph num="(b)"> <text>Provides advice in the professional’s area of expertise; and</text> </paragraph> <paragraph num="(c)"> <text>Is a contractor if paid, and a volunteer if not paid.</text> </paragraph> </paragraph> <paragraph num="(17)"> <text>“Core service agency (CSA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded mental health services.</text> </paragraph> <paragraph num="(18)"> <text>Correctional Facility.</text> <paragraph num="(a)"> <text>“Correctional facility” means an institution overseen by the State or one of the 24 subdivisions where individuals are incarcerated.</text> </paragraph> <paragraph num="(b)"> <text>“Correctional facility” includes a:</text> <paragraph num="(i)"> <text>Jail;</text> </paragraph> <paragraph num="(ii)"> <text>Detention center;</text> </paragraph> <paragraph num="(iii)"> <text>Prison; or</text> </paragraph> <paragraph num="(iv)"> <text>Correctional halfway house.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Critical incident” means any of the following:</text> <paragraph num="(a)"> <text>Death of a program participant;</text> </paragraph> <paragraph num="(b)"> <text>Life threatening injury to a program participant;</text> </paragraph> <paragraph num="(c)"> <text>Non-consensual sexual activity, as prohibited in COMAR 10.01.18;</text> </paragraph> <paragraph num="(d)"> <text>Any sexual activity between a staff member and a program participant;</text> </paragraph> <paragraph num="(e)"> <text>Unexpected evacuation of a building under circumstances that threaten the life, health or safety of participants;</text> </paragraph> <paragraph num="(f)"> <text>Diversion of medication from the stock of a program providing opioid treatment services; or</text> </paragraph> <paragraph num="(g)"> <text>Any injury related to an opioid medication dispensed by a program providing opioid treatment services.</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>“Deficiency” means a failure to meet an accreditation standard, or a relevant federal, State, or local ordinance, law, regulation, or building code, as applicable.</text> </paragraph> <paragraph num="(21)"> <text>“Deemed status” means the procedure, pursuant to COMAR 10.21.16.10 or COMAR 10.47.04.05E under which programs with accreditation from an approved accreditation organization are permitted to operate in Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Demonstration project” means an experimental project that, if deemed successful, will be considered for future adoption.</text> </paragraph> <paragraph num="(23)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(24)"> <text>“Designated approval unit” means the office within the Department that is designated by the Secretary to:</text> <paragraph num="(a)"> <text>Evaluate applications for licenses to provide behavioral health and other health-related services in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Issue licenses to provide the services;</text> </paragraph> <paragraph num="(c)"> <text>Investigate allegations of deficient services; and</text> </paragraph> <paragraph num="(d)"> <text>Impose sanctions for deficiencies in service.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>“Directed plan of correction” means the program’s plan of correction, as defined in this subtitle that is mandated by the Department.</text> </paragraph> <paragraph num="(26)"> <text>“Discharge” means the release of a participant from a program.</text> </paragraph> <paragraph num="(27)"> <text>“Drug” means:</text> <paragraph num="(a)"> <text>A controlled dangerous substance that is regulated under the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101 — 5-1101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>A prescription medication; or</text> </paragraph> <paragraph num="(c)"> <text>A chemical substance when used for unintended and harmful purposes.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Exempt provider” means a provider that, under Health-General Article, §7.5-401, Annotated Code of Maryland, is not required to be licensed by the Secretary to provide services in Maryland.</text> </paragraph> <paragraph num="(29)"> <text>“Family” means an individual’s immediate relatives or significant others.</text> </paragraph> <paragraph num="(30)"> <text>“Family provided support services” means a set of non-clinical activities provided by family members of individuals with mental health or substance-related and addictive disorders to support individuals with the disorders or their families.</text> </paragraph> <paragraph num="(31)"> <text>Group Home.</text> <paragraph num="(a)"> <text>“Group home” means a residential program as defined in Health-General Article, §10-514, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(b)"> <text>“Group home” does not include:</text> <paragraph num="(i)"> <text>A foster home that is the domicile of the foster parent;</text> </paragraph> <paragraph num="(ii)"> <text>A facility that is owned or leased to the State or any public agency;</text> </paragraph> <paragraph num="(iii)"> <text>A facility that is regulated by the Department of Juvenile Services or the Developmental Disabilities Administration; or</text> </paragraph> <paragraph num="(iv)"> <text>Organized wholly or partially to make a profit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(32)"> <text>“Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(33)"> <text>“Jurisdiction” means Baltimore City or one of the 23 counties in Maryland.</text> </paragraph> <paragraph num="(34)"> <text>“License” means the approval issued by the Secretary or designee that permits a behavioral health provider to operate in Maryland.</text> </paragraph> <paragraph num="(35)"> <text>“Local addictions authority (LAA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded substance-related and addictive disorder services.</text> </paragraph> <paragraph num="(36)"> <text>“Local behavioral health authority (LBHA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded mental health, substance-related, and addictive disorder services.</text> </paragraph> <paragraph num="(37)"> <text>“Maintenance” means medically supervised continuation of the administration of methadone or other drugs approved by the Administration.</text> </paragraph> <paragraph num="(38)"> <text>“Medical director” means a physician who oversees the medical practice of a program.</text> </paragraph> <paragraph num="(39)"> <text>“Multidisciplinary” means a mix of representatives from at least three different mental health professions licensed in accordance with the Health Occupations Article, one of whom shall be:</text> <paragraph num="(a)"> <text>A psychiatrist;</text> </paragraph> <paragraph num="(b)"> <text>An advanced practice registered nurse-psychiatric mental health; or</text> </paragraph> <paragraph num="(c)"> <text>A certified registered nurse practitioner-psychiatric mental health.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>“Non-accreditation-based license” means a license that may be issued or received without the provider being accredited by an approved accreditation organization.</text> </paragraph> <paragraph num="(41)"> <text>“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health.</text> </paragraph> <paragraph num="(42)"> <text>“Patient” means an individual receiving care and treatment in a community behavioral health program.</text> </paragraph> <paragraph num="(43)"> <text>“Peer support services” means a set of non-clinical activities provided by individuals in recovery from mental health or substance-related and addictive disorders who use their personal, lived experiences and training to support other individuals with mental health or substance-related and addictive disorders.</text> </paragraph> <paragraph num="(44)"> <text>“Physician” means an individual who is licensed and legally authorized to practice medicine:</text> <paragraph num="(a)"> <text>Under Health Occupations Article, §14-101, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>In the state where the service is given.</text> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Pilot project” means an experimental project that, if deemed successful, will be adopted as a permanent policy or program.</text> </paragraph> <paragraph num="(46)"> <text>“Plan of correction” means the program’s proposed response to findings of deficiency identified by the Department’s designated approval unit or the Department.</text> </paragraph> <paragraph num="(47)"> <text>“Program” means an organization that provides or seeks a license to provide community-based behavioral health services.</text> </paragraph> <paragraph num="(48)"> <text>“Program director” means the individual who has over-all responsibility for the day-to-day activities of the program, including staff, records, policies, and procedures.</text> </paragraph> <paragraph num="(49)"> <text>“Provider” means a program that is approved, certified or licensed to provide community-based behavioral health services.</text> </paragraph> <paragraph num="(50)"> <text>“Psychiatrist” means a physician who:</text> <paragraph num="(a)"> <text>Is licensed by the Maryland Board of Physicians; and</text> </paragraph> <paragraph num="(b)"> <text>Is either:</text> <paragraph num="(i)"> <text>Certified in psychiatry by the American Board of Psychiatry and Neurology; or</text> </paragraph> <paragraph num="(ii)"> <text>Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(51)"> <text>“Recovery residence” means a service that provides alcohol-free and illicit drug-free housing to individuals with substance-related disorders or addictive disorders or co-occurring mental health and substance-related disorders or addictive disorders, and that does not include clinical treatment services.</text> </paragraph> <paragraph num="(52)"> <text>“Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.</text> </paragraph> <paragraph num="(53)"> <text>“Residence” means a housing unit leased or owned by a licensed residential rehabilitation program.</text> </paragraph> <paragraph num="(54)"> <text>“Resident” means an individual who resides in a community-based residential behavioral health program.</text> </paragraph> <paragraph num="(55)"> <text>“Secretary” means the Secretary of Health or the Secretary’s designee.</text> </paragraph> <paragraph num="(56)"> <text>“Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.</text> </paragraph> <paragraph num="(57)"> <text>“Variance” means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration.</text> </paragraph> <paragraph num="(58)"> <text>“Waiver” means the exemption from compliance with a regulation under this subtitle.</text> </paragraph> <paragraph num="(59)"> <text>“Withdrawal management” means direct or indirect services for an individual manifesting the symptoms that occur on cessation or reduction of use of a substance or medication, by:</text> <paragraph num="(a)"> <text>Monitoring the amount of alcohol and other toxic agents in the body of the individual;</text> </paragraph> <paragraph num="(b)"> <text>Managing withdrawal symptoms; and</text> </paragraph> <paragraph num="(c)"> <text>Motivating an individual to participate in the appropriate substance-related disorder programs.</text> </paragraph> </paragraph> <paragraph num="(60)"> <text>“Working day” means any day except Saturday, Sunday, or other day on which State offices are closed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <paragraph num="A."> <text>Except as provided in Regulation .04 of this chapter, an individual or entity shall have a valid and current license issued by the Department under this subtitle in order to provide community-based behavioral health services in Maryland.</text> </paragraph> <paragraph num="B."> <text>A license issued under this subtitle may not be transferred.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Exempt Providers."> <paragraph num="A."> <text>In accordance with Health-General Article, §7.5-401, Annotated Code of Maryland, the following providers are exempt from the requirements of, and are not required to be licensed under, this subtitle:</text> <paragraph num="(1)"> <text>Except as provided in §B of this regulation:</text> <paragraph num="(a)"> <text>A health professional, in either a solo practice or group practice, who is licensed under the Health Occupations Article; and</text> </paragraph> <paragraph num="(b)"> <text>Is providing services in accordance with the requirements of the appropriate professional board;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Alcoholics Anonymous;</text> </paragraph> <paragraph num="(3)"> <text>Narcotics Anonymous;</text> </paragraph> <paragraph num="(4)"> <text>Recovery residences;</text> </paragraph> <paragraph num="(5)"> <text>Peer support services;</text> </paragraph> <paragraph num="(6)"> <text>Family-provided support services;</text> </paragraph> <paragraph num="(7)"> <text>An employees’ assistance program of a business entity;</text> </paragraph> <paragraph num="(8)"> <text>Outpatient behavioral health treatment and rehabilitation services provided in regulated space of a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland, if the hospital is accredited by an approved accreditation organization under the accreditation organization’s behavioral health standards; and</text> </paragraph> <paragraph num="(9)"> <text>A therapeutic group home authorized under:</text> <paragraph num="(a)"> <text>Health-General Article, §§10-920 — 10-923, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 10.21.07; and</text> </paragraph> <paragraph num="(c)"> <text>COMAR 14.31.05 — 14.31.07;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notwithstanding the provisions of §A of this regulation, a provider shall have a valid and current license under this subtitle in order to provide the following services:</text> <paragraph num="(1)"> <text>DUI education programs as described in COMAR 10.63.05.05; and</text> </paragraph> <paragraph num="(2)"> <text>Substance-related disorder programs as described in COMAR 10.63.03.11 — .14.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may exempt a program from the requirements of this subtitle:</text> <paragraph num="(1)"> <text>If the program:</text> <paragraph num="(a)"> <text>Is a pilot project;</text> </paragraph> <paragraph num="(b)"> <text>Is a federal or State demonstration project; or</text> </paragraph> <paragraph num="(c)"> <text>Does not fall within any of the program descriptions set out in:</text> <paragraph num="(i)"> <text>COMAR 10.63.03;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 10.63.04; or</text> </paragraph> <paragraph num="(iii)"> <text>COMAR 10.63.05; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the program demonstrates to the satisfaction of the Department that it is subject to:</text> <paragraph num="(a)"> <text>Contractual provisions;</text> </paragraph> <paragraph num="(b)"> <text>Conditions of grant award; or</text> </paragraph> <paragraph num="(c)"> <text>Other requirements that are comparable to the regulations in this subtitle.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Requirements for Licensed Community-Based Behavioral Health Program."> <paragraph num="A."> <text>A program licensed under this subtitle to provide community-based behavioral health services in Maryland shall comply with the requirements listed in this regulation.</text> </paragraph> <paragraph num="B."> <text>Post-Licensing Inspections.</text> <paragraph num="(1)"> <text>The Department or its designees may make announced or unannounced visits to inspect a program to investigate a complaint.</text> </paragraph> <paragraph num="(2)"> <text>The Department or its designees may inspect and copy records, including, but not limited to:</text> <paragraph num="(a)"> <text>Financial records;</text> </paragraph> <paragraph num="(b)"> <text>Treatment records; and</text> </paragraph> <paragraph num="(c)"> <text>Service records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Criminal Background Investigation.</text> <paragraph num="(1)"> <text>To be licensed in accordance with this chapter, a program shall have and follow a written policy that complies with §C(2) of this regulation regarding the criminal history of the program’s employees, contractors, and volunteers.</text> </paragraph> <paragraph num="(2)"> <text>At a minimum, the program’s policy shall require that, when deciding whether the criminal history of an individual applying for employment, whether paid or volunteer, and a contractor disqualifies the individual from the employment, the program consider:</text> <paragraph num="(a)"> <text>The age at which the individual committed the crime;</text> </paragraph> <paragraph num="(b)"> <text>The circumstances surrounding the crime;</text> </paragraph> <paragraph num="(c)"> <text>Any punishment imposed for the crime, including any subsequent court actions regarding that punishment;</text> </paragraph> <paragraph num="(d)"> <text>The length of time that has passed since the crime;</text> </paragraph> <paragraph num="(e)"> <text>Subsequent work history;</text> </paragraph> <paragraph num="(f)"> <text>Employment and character references; and</text> </paragraph> <paragraph num="(g)"> <text>Other evidence that demonstrates whether the employee, contractor, or volunteer poses a threat to the health or safety of a program participant, program staff, or a member of the public.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The program may not hire an individual as an employee, contractor, or volunteer if the program does not receive and consider the criminal history record information required under this regulation.</text> </paragraph> <paragraph num="(4)"> <text>An individual may not be hired as an employee, contractor, or volunteer:</text> <paragraph num="(a)"> <text>For a program serving participants younger than 18 years old, if the individual has been convicted at any time of child abuse or child sexual abuse; or</text> </paragraph> <paragraph num="(b)"> <text>For a program serving participants 18 years old or older, if the individual has been convicted at any time of abuse or neglect of a vulnerable adult.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The criminal background investigation policy may be stricter than that required by this regulation, as appropriate, to protect program participants.</text> </paragraph> <paragraph num="(6)"> <text>A program shall:</text> <paragraph num="(a)"> <text>Document the programs’:</text> <paragraph num="(i)"> <text>Review of criminal history records of potential employees, contractors, and volunteers;</text> </paragraph> <paragraph num="(ii)"> <text>Decision regarding the impact of the criminal history on the employability of each applicant for employment and on each employee, contractor, and volunteer; and</text> </paragraph> <paragraph num="(iii)"> <text>Implementation of the policy required by §C(1) of this regulation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Maintain the documentation required by this regulation for 3 years after the individual either is not hired or leaves employment with the program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Applicable Laws. A program licensed in accordance with this chapter shall comply with all applicable federal and State laws and regulations, including the following:</text> <paragraph num="(1)"> <text>The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and regulations implementing the statute, as amended;</text> </paragraph> <paragraph num="(2)"> <text>Federal Regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2, as amended;</text> </paragraph> <paragraph num="(3)"> <text>State confidentiality statutes, including:</text> <paragraph num="(a)"> <text>Health-General Article, §4-301, et seq., Annotated Code of Maryland, as amended; and</text> </paragraph> <paragraph num="(b)"> <text>General Provisions Article, §4-101, et seq., as amended;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Current applicable State confidentiality regulations;</text> </paragraph> <paragraph num="(5)"> <text>The Americans With Disabilities Act, 42 U.S.C. §12101, et seq.; and</text> </paragraph> <paragraph num="(6)"> <text>The federal Fair Housing Act, 42 U.S.C. §3604.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Agreement to Cooperate.</text> <paragraph num="(1)"> <text>Before applying for licensure, a program shall enter into an agreement to cooperate with the CSA, LAA, or LBHA that operates in the relevant county or Baltimore City.</text> </paragraph> <paragraph num="(2)"> <text>The agreement to cooperate shall provide for coordination and cooperation between the parties in carrying out behavioral health activities in the jurisdiction, including but not limited to facilitating:</text> <paragraph num="(a)"> <text>A complaint investigation; and</text> </paragraph> <paragraph num="(b)"> <text>The transition of services if:</text> <paragraph num="(i)"> <text>The program closes; or</text> </paragraph> <paragraph num="(ii)"> <text>A program discontinues a service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The agreement to cooperate may not include a provision that authorizes the CSA, LAA, or LBHA to prohibit a program from offering services at any location.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Opioid Treatment Services—Non-Discrimination. A program may not exclude or discriminate against an individual on the basis of the individual receiving opioid treatment services.</text> </paragraph> <paragraph num="G."> <text>Critical Incident Reports. A licensed program shall report all critical incidents to the Department, or its designee, within 5 calendar days following the program receiving knowledge of the incident, on the form required by the Department.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> </annotations> </chapter> <chapter num="02" heading="Programs Required to Be Accredited in Order to Be Licensed to Provide Community-Based Behavioral Health Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter identifies those programs that are required to be accredited in order to receive a license to provide community-based behavioral health services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Covered Programs and Services."> <paragraph num="A."> <text>The following programs shall require an accreditation-based license under this chapter:</text> <paragraph num="(1)"> <text>Group Homes for Adults with Mental Illness programs;</text> </paragraph> <paragraph num="(2)"> <text>Integrated Behavioral Health programs;</text> </paragraph> <paragraph num="(3)"> <text>Intensive Outpatient Treatment Level 2.1 programs;</text> </paragraph> <paragraph num="(4)"> <text>Mobile Treatment Services (MTS) programs;</text> </paragraph> <paragraph num="(5)"> <text>Outpatient Mental Health Center (OMHC) programs;</text> </paragraph> <paragraph num="(6)"> <text>Outpatient Treatment Level 1 programs;</text> </paragraph> <paragraph num="(7)"> <text>Partial Hospitalization Treatment Level 2.5 programs;</text> </paragraph> <paragraph num="(8)"> <text>Psychiatric Day Treatment Program (PDTP) programs;</text> </paragraph> <paragraph num="(9)"> <text>Psychiatric Rehabilitation Program for Adults (PRP-A) programs;</text> </paragraph> <paragraph num="(10)"> <text>Psychiatric Rehabilitation Program for Minors (PRP-M) programs;</text> </paragraph> <paragraph num="(11)"> <text>Residential Crisis Services (RCS) programs;</text> </paragraph> <paragraph num="(12)"> <text>Residential: Low Intensity Level 3.1 programs;</text> </paragraph> <paragraph num="(13)"> <text>Residential: Medium Intensity Level 3.3 programs;</text> </paragraph> <paragraph num="(14)"> <text>Residential: High Intensity Level 3.5 programs;</text> </paragraph> <paragraph num="(15)"> <text>Residential: Intensive Level 3.7 programs;</text> </paragraph> <paragraph num="(16)"> <text>Residential Rehabilitation Program (RRP) programs;</text> </paragraph> <paragraph num="(17)"> <text>Respite Care Services (RPCS) programs;</text> </paragraph> <paragraph num="(18)"> <text>Supported Employment Program (SEP) programs;</text> </paragraph> <paragraph num="(19)"> <text>Mobile Crisis Team programs; and</text> </paragraph> <paragraph num="(20)"> <text>Behavioral Health Crisis Stabilization Center (BHCSC) programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Of the licensed community-based behavioral health services programs listed in §A of this regulation, the following may provide the services identified in §C of this regulation, so long as the program’s license specifically authorizes the service:</text> <paragraph num="(1)"> <text>Integrated Behavioral Health programs;</text> </paragraph> <paragraph num="(2)"> <text>Intensive Outpatient Treatment Level 2.1 programs;</text> </paragraph> <paragraph num="(3)"> <text>Outpatient Treatment Level 1 programs;</text> </paragraph> <paragraph num="(4)"> <text>Partial Hospitalization Treatment Level 2.5 programs;</text> </paragraph> <paragraph num="(5)"> <text>Residential: Low Intensity Level 3.1 programs;</text> </paragraph> <paragraph num="(6)"> <text>Residential: Medium intensity Level 3.3 programs;</text> </paragraph> <paragraph num="(7)"> <text>Residential: High intensity Level 3.5 programs; and</text> </paragraph> <paragraph num="(8)"> <text>Residential: Intensive Level 3.7 programs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Programs listed in §B of this regulation and licensed to provide community-based behavioral health services may provide the following services so long as the program’s license specifically authorizes the service:</text> <paragraph num="(1)"> <text>Withdrawal Management Service; and</text> </paragraph> <paragraph num="(2)"> <text>Opioid Treatment Service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements for a Program with an Accreditation-Based License."> <paragraph num="A."> <text>In addition to complying with the requirements for licensed community-based behavioral health programs specified in COMAR 10.63.01.05, a program with an accreditation-based license to provide community-based behavioral health services in Maryland shall comply with this regulation.</text> </paragraph> <paragraph num="B."> <text>A program with an accreditation-based license shall comply with the requirements and meet the standards of the accreditation organization by which it is accredited.</text> </paragraph> <paragraph num="C."> <text>The Department or its designee may enforce any requirement or standard of the accreditation organization by which a program is accredited.</text> </paragraph> <paragraph num="D."> <text>In addition to the post-licensing inspections provided for in COMAR 10.63.01.05B, a program with an accreditation-based license shall be subject to inspection by the Department or its designees in cases in which significant concerns have been raised regarding operation of the program or the organization that accredited the program, in order to:</text> <paragraph num="(1)"> <text>Determine compliance with a requirement under its accreditation;</text> </paragraph> <paragraph num="(2)"> <text>Follow-up on any problem identified by the accreditation organization that accredited the program; or</text> </paragraph> <paragraph num="(3)"> <text>Validate the findings of the accreditation organization that accredited the program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Halfway House and Group Home Sites."> <text>A licensed halfway house and group home shall ensure that its sites comply with Health-General Article, §§8-406 and 10-518, Annotated Code of Maryland, as follows:</text> <paragraph num="A."> <text>A small halfway house or private group home is considered conclusively a single-family dwelling for purposes of zoning, and may be located in all residential zones;</text> </paragraph> <paragraph num="B."> <text>A large halfway house or private group home is considered conclusively a multi-family dwelling for purposes of zoning and may be located in zones of similar density; and</text> </paragraph> <paragraph num="C."> <text>A halfway house or a private group home may not be made subject to any special exception, conditional use permit, or procedure that differs from that required for a single-family dwelling or a multi-family dwelling of similar density in the same zone.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 27, 2024 (51:10 Md. R. 526)</annotation> </annotations> </chapter> <chapter num="03" heading="Descriptions and Criteria for Programs and Services Required to Have an Accreditation-Based License"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the descriptions of and the criteria for the community behavioral health programs that are permitted to operate in Maryland, so long as they have valid and current accreditation-based licenses under this subtitle.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Integrated Behavioral Health Program."> <paragraph num="A."> <text>To be licensed under this subtitle, an integrated behavioral health program shall:</text> <paragraph num="(1)"> <text>Meet the requirements for an:</text> <paragraph num="(a)"> <text>Outpatient mental health center, as outlined in Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Outpatient treatment level 1 program, as outlined in Regulation .06 of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have the capacity to provide, as appropriate:</text> <paragraph num="(a)"> <text>Mental health evaluation and treatment services to individuals with mental health diagnoses;</text> </paragraph> <paragraph num="(b)"> <text>Substance-related disorder evaluation and treatment services to individuals with a substance-related disorder; and</text> </paragraph> <paragraph num="(c)"> <text>Integrated mental health and substance-related disorder evaluation and treatment services to individuals with both a substance use disorder and a mental health diagnosis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An integrated behavioral health program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Intensive Outpatient Treatment Level 2.1 Program."> <paragraph num="A."> <text>To be licensed under this subtitle, an intensive outpatient treatment level 2.1 program shall provide structured outpatient substance-related disorder treatment based on a comprehensive assessment, for:</text> <paragraph num="(1)"> <text>Individuals who meet the ASAM Criteria for level 2.1; and</text> </paragraph> <paragraph num="(2)"> <text>Adults, from 9 to 20 hours weekly, and individuals younger than 18 years old for 6 to 20 hours weekly.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An intensive outpatient treatment level 2.1 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Mobile Treatment Services Program."> <text>In order to be licensed under this subtitle, a mobile treatment services program shall:</text> <paragraph num="A."> <text>Provide intensive, assertive outpatient mental health treatment and support services by a multidisciplinary team to an individual who is homeless or is otherwise unable or unwilling to access traditional outpatient treatment services as follows:</text> <paragraph num="(1)"> <text>Flexibly in a community setting considered appropriate to the individual; and</text> </paragraph> <paragraph num="(2)"> <text>On an on-call basis, 24 hours per day, 7 days a week;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Be designed to enable the individual to remain in the community, thus reducing admissions to emergency rooms, inpatient facilities, or detention facilities; and</text> </paragraph> <paragraph num="C."> <text>Provide discharge services, including developing a transition plan and arranging to initiate authorized services before the planned discharge, in collaboration with the individual, the treatment team, family members, and significant others who are designated by the individual, the CSA, LBHA, ASO and the designated transition service providers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Outpatient Mental Health Center."> <text>In order to be licensed under this subtitle, an outpatient mental health center shall:</text> <paragraph num="A."> <text>Provide regularly-scheduled outpatient mental health treatment services in a community-based setting;</text> </paragraph> <paragraph num="B."> <text>Provide, at a minimum, individual, group, and family therapy and medication management;</text> </paragraph> <paragraph num="C."> <text>Employ a medical director, who:</text> <paragraph num="(1)"> <text>Is a psychiatrist;</text> </paragraph> <paragraph num="(2)"> <text>Has over-all responsibility for clinical services; and</text> </paragraph> <paragraph num="(3)"> <text>Is on-site at least 20 hours per week; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Employ multidisciplinary clinical treatment staff who is authorized to provide the services under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Outpatient Treatment Level 1 Program."> <paragraph num="A."> <text>In order to be licensed under this subtitle, an outpatient treatment level 1 program shall provide outpatient substance-related disorder treatment based on a comprehensive assessment:</text> <paragraph num="(1)"> <text>For individuals who:</text> <paragraph num="(a)"> <text>Meet the ASAM Criteria for level 1;</text> </paragraph> <paragraph num="(b)"> <text>Have a physical and emotional status that allows the individual to function in the individual’s usual environment; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For adults, require services for fewer than 9 hours weekly, or, for individuals younger than 18 years old, require services for fewer than 6 hours weekly.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An outpatient treatment level 1 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Partial Hospitalization Treatment Level 2.5 Program."> <paragraph num="A."> <text>A partial hospitalization treatment level 2.5 program shall provide structured outpatient substance-related disorder treatment based on a comprehensive assessment for:</text> <paragraph num="(1)"> <text>Individuals who meet the ASAM Criteria for level 2.5; and</text> </paragraph> <paragraph num="(2)"> <text>From 20 to 35 hours weekly.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A partial-hospitalization treatment-level 2.5 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Psychiatric Day Treatment Program (PDTP)."> <text>In order to be licensed under this subtitle, a psychiatric day treatment program (PDTP) shall:</text> <paragraph num="A."> <text>Provide short-term, intensive, day or evening mental health treatment and support services for individuals who do not require 24-hour care;</text> </paragraph> <paragraph num="B."> <text>Focus on the amelioration of an individual’s acute psychiatric symptoms; and</text> </paragraph> <paragraph num="C."> <text>Be medically supervised and staffed by a multidisciplinary treatment team that includes, at a minimum:</text> <paragraph num="(1)"> <text>A psychiatrist; and</text> </paragraph> <paragraph num="(2)"> <text>A registered nurse.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Psychiatric Rehabilitation Program for Adults (PRP-A)."> <text>In order to be licensed under this subtitle, a psychiatric rehabilitation program for adults (PRP-A) shall:</text> <paragraph num="A."> <text>Provide community-based comprehensive rehabilitation and recovery services and supports, including, but not limited to:</text> <paragraph num="(1)"> <text>Community living skills;</text> </paragraph> <paragraph num="(2)"> <text>Activities of daily living; and</text> </paragraph> <paragraph num="(3)"> <text>Family and peer support;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Promote successful community integration and use of community resources;</text> </paragraph> <paragraph num="C."> <text>Be under the direction of a rehabilitation specialist who is:</text> <paragraph num="(1)"> <text>A licensed mental health professional;</text> </paragraph> <paragraph num="(2)"> <text>Certified by the Commission on Rehabilitation Counselor Certification; or</text> </paragraph> <paragraph num="(3)"> <text>Certified by the Psychiatric Rehabilitation Association; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Employ the rehabilitation specialist in §C of this regulation:</text> <paragraph num="(1)"> <text>At least 20 hours per week when the program serves less than 30 individuals; or</text> </paragraph> <paragraph num="(2)"> <text>40 hours per week when the program serves 30 individuals or more.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Psychiatric Rehabilitation Program for Minors (PRP-M)."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a psychiatric rehabilitation program for minors (PRP-M) shall provide community-based comprehensive rehabilitation services and supports designed to:</text> <paragraph num="(1)"> <text>Promote resiliency; and</text> </paragraph> <paragraph num="(2)"> <text>Facilitate the development or restoration of appropriate skills in an individual younger than 18 years old including but not limited to:</text> <paragraph num="(a)"> <text>Self-care skills;</text> </paragraph> <paragraph num="(b)"> <text>Social, peer, family, and teacher interactions; and</text> </paragraph> <paragraph num="(c)"> <text>Semi-independent living skills; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Promote successful integration into the community and the use of community resources.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program shall be under the direction of a rehabilitation specialist who has a minimum of 2 years direct care experience working with youth with a serious emotional disorder and who is:</text> <paragraph num="(1)"> <text>A licensed mental health professional; or</text> </paragraph> <paragraph num="(2)"> <text>Certified by the Psychiatric Rehabilitation Association and has obtained the Psychiatric Rehabilitation Association Children’s Psychiatric Rehabilitation Certificate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The PRP-M shall employ the rehabilitation specialist in §B of this regulation for:</text> <paragraph num="(1)"> <text>At least 20 hours per week when the program serves less than 30 individuals; or</text> </paragraph> <paragraph num="(2)"> <text>At least 40 hours per week when the program serves 30 individuals or more.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Residential-Low Intensity Level 3.1 Program."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a residential-low intensity level 3.1 program shall provide clinically-managed, low intensity, substance-related disorder treatment in large and small halfway houses, as defined in Health-General Article, §8-101, Annotated Code of Maryland, to individuals who:</text> <paragraph num="(1)"> <text>Meet the ASAM Criteria for level 3.1; and</text> </paragraph> <paragraph num="(2)"> <text>Are capable of self-care but are not ready to return to family or independent living.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Services shall be:</text> <paragraph num="(1)"> <text>Provided for a minimum of 5 hours per week, and</text> </paragraph> <paragraph num="(2)"> <text>Directed toward:</text> <paragraph num="(a)"> <text>Preventing relapse;</text> </paragraph> <paragraph num="(b)"> <text>Applying recovery skills; and</text> </paragraph> <paragraph num="(c)"> <text>Reintegrating into the community.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A residential-low intensity level 3.1 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Residential-Medium Intensity Level 3.3 Program."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a residential-medium intensity level 3.3 program shall provide clinically-managed, medium intensity, substance-related disorder treatment based on a comprehensive assessment:</text> <paragraph num="(1)"> <text>In a structured environment in combination with medium-intensity treatment and ancillary services to support and promote recovery;</text> </paragraph> <paragraph num="(2)"> <text>From 20 to 35 hours weekly; and</text> </paragraph> <paragraph num="(3)"> <text>To individuals who:</text> <paragraph num="(a)"> <text>Meet the ASAM Criteria for level 3.3;</text> </paragraph> <paragraph num="(b)"> <text>Are chronic alcohol- or other drug-dependent;</text> </paragraph> <paragraph num="(c)"> <text>Do not need skilled nursing care;</text> </paragraph> <paragraph num="(d)"> <text>May have a history of multiple admissions to substance related disorder programs described in this chapter;</text> </paragraph> <paragraph num="(e)"> <text>May have physical or mental disabilities resulting from a prolonged substance-related disorder; and</text> </paragraph> <paragraph num="(f)"> <text>Have been identified as requiring a controlled environment and supportive therapy for an indefinite period of time.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A residential-medium intensity level 3.3 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Residential-High Intensity Level 3.5 Program."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a residential-high intensity level 3.5 program shall provide clinically-managed, high-intensity, substance-related disorder treatment services based on a comprehensive assessment:</text> <paragraph num="(1)"> <text>In a highly-structured environment, in combination with moderate- to high-intensity treatment and ancillary services to support and promote recovery;</text> </paragraph> <paragraph num="(2)"> <text>For a minimum of 36 hours of therapeutic activities a week;</text> </paragraph> <paragraph num="(3)"> <text>That are characterized by reliance on the treatment community as a therapeutic agent; and</text> </paragraph> <paragraph num="(4)"> <text>To individuals who meet the ASAM Criteria for level 3.5.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A residential-high intensity level 3.5 program may provide the following services if the program’s license specifically authorizes the services:</text> <paragraph num="(1)"> <text>A withdrawal management service as described in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>An opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Residential-Intensive Level 3.7 Program."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a residential-intensive level 3.7 program shall provide medically-monitored, intensive substance-related disorder treatment based on a comprehensive assessment:</text> <paragraph num="(1)"> <text>To individuals who meet the ASAM Criteria for level 3.7;</text> </paragraph> <paragraph num="(2)"> <text>For a minimum of 36 hours of therapeutic activities a week;</text> </paragraph> <paragraph num="(3)"> <text>On a planned regimen of 24-hour evaluation, care, and treatment in a residential setting;</text> </paragraph> <paragraph num="(4)"> <text>In an Intermediate Care Facility Type C/D; and</text> </paragraph> <paragraph num="(5)"> <text>While meeting the requirements for withdrawal management services as outlined in Regulation .18 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the program's license specifically authorizes the service, a residential-intensive level 3.7 program may provide an opioid treatment service as described in Regulation .19 of this chapter.</text> </paragraph> <paragraph num="C."> <text>A residential-intensive level 3.7 program shall employ a physician, nurse practitioner, or physician assistant who:</text> <paragraph num="(1)"> <text>Assesses each patient in person within 24 hours of admission or earlier, if medically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Assesses each patient thereafter, as medically necessary; and</text> </paragraph> <paragraph num="(3)"> <text>Is available to provide on-site monitoring of care and further evaluation on a daily basis.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Respite Care Services Program (RPCS)."> <text>In order to be licensed under this subtitle, a respite care services (RPCS) program:</text> <paragraph num="A."> <text>Shall provide short-term, in home or overnight temporary services to support an individual to remain in the individual’s home:</text> <paragraph num="(1)"> <text>Through enhanced support or a temporary alternate living arrangement; or</text> </paragraph> <paragraph num="(2)"> <text>By temporarily freeing the caregiver from the responsibility of caring for the individual; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>For individuals younger than 21 years old, may offer overnight respite in an appropriately licensed program or therapeutic foster care home.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Supported Employment Program (SEP)."> <text>In order to be licensed under this subtitle, a supported employment program (SEP) shall:</text> <paragraph num="A."> <text>Provide services designed to assist an individual to choose, obtain, and maintain competitive employment; and</text> </paragraph> <paragraph num="B."> <text>Assist an individual to obtain competitive employment in an integrated work environment that provides:</text> <paragraph num="(1)"> <text>Compensation of at least minimum wage;</text> </paragraph> <paragraph num="(2)"> <text>An individualized approach that establishes an hours-per-week employment goal to maximize an individual’s vocational potential; and</text> </paragraph> <paragraph num="(3)"> <text>Additional supports, as needed, delivered where appropriate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Substance-Related Disorder Treatment Program in Correctional Facilities."> <text>A substance-related disorder treatment program located in a State or local correctional facility requires a license under this chapter in order to operate.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Withdrawal Management Service."> <text>A withdrawal management service is one that:</text> <paragraph num="A."> <text>May be provided at one or more of the following ASAM levels:</text> <paragraph num="(1)"> <text>Level 1-WM, ambulatory withdrawal management without extended on-site monitoring;</text> </paragraph> <paragraph num="(2)"> <text>Level 2-WM, ambulatory withdrawal management with extended on-site monitoring;</text> </paragraph> <paragraph num="(3)"> <text>Level 3.2-WM, clinically-managed residential withdrawal management; or</text> </paragraph> <paragraph num="(4)"> <text>Level 3.7-WM, medically-monitored residential withdrawal management;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Monitors the decreasing amount of psychoactive substances in the body;</text> </paragraph> <paragraph num="C."> <text>Manages the withdrawal symptoms;</text> </paragraph> <paragraph num="D."> <text>Motivates the individual to participate in appropriate treatment programs for alcohol or other drug dependence;</text> </paragraph> <paragraph num="E."> <text>Provides additional referrals as necessary; and</text> </paragraph> <paragraph num="F."> <text>At Level I-WM, Level 2-WM, and Level 3.7-WM, employs a physician, nurse practitioner, or physician assistant who:</text> <paragraph num="(1)"> <text>Obtains a comprehensive medical history and physical examination of the patient at admission; and</text> </paragraph> <paragraph num="(2)"> <text>Medically monitors each patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Opioid Treatment Service."> <text>An opioid treatment service is one that:</text> <paragraph num="A."> <text>Complies with the requirements of 42 CFR §8;</text> </paragraph> <paragraph num="B."> <text>Is under the direction of a medical director who is a physician and:</text> <paragraph num="(1)"> <text>Has at least 3 years of documented experience providing services to persons with substance-related disorders and opioid use disorders, including at least 1 year of experience in the treatment of opioid use disorder with opioid maintenance therapy and is board-certified in addiction medicine or addiction psychiatry; or</text> </paragraph> <paragraph num="(2)"> <text>Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Uses pharmacological interventions, including dispensing of full and partial opiate agonist treatment medications as part of treatment, support, and recovery services to an individual with an opioid addiction;</text> </paragraph> <paragraph num="D."> <text>Provides clinical services to each patient at a frequency based on the patient’s clinical stability level, not to exceed an overall program average of 50:1 patient-to-counselor ratio;</text> </paragraph> <paragraph num="E."> <text>Arranges for any opioid maintenance medication dispensed to a patient to be transported to the following service sites:</text> <paragraph num="(1)"> <text>Residential programs at Levels 3.3, 3.5, and 3.7, as described in Regulations .12—.14 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Withdrawal management services at ASAM levels 3.2-WM and 3.7-WM as described in Regulation .18 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Residential programs at levels 3.1, when the patient, because of a developmental or physical disability, or lack of access to transportation, cannot obtain or transport the patient’s take-home opioid maintenance medication;</text> </paragraph> </paragraph> <paragraph num="F."> <text>In accordance with 21 CFR §1300, et seq., arranges transportation of opioid maintenance medication from the program sites identified in §E of this regulation or confirms the disposal of such medication when a patient leaves residential levels of care;</text> </paragraph> <paragraph num="G."> <text>Conducts random drug testing on each patient at least monthly, according to the provisions of COMAR 10.10.03.02;</text> </paragraph> <paragraph num="H."> <text>Conducts random drug testing, at a minimum, for the following substances:</text> <paragraph num="(1)"> <text>Benzodiazepines;</text> </paragraph> <paragraph num="(2)"> <text>Marijuana;</text> </paragraph> <paragraph num="(3)"> <text>Cocaine;</text> </paragraph> <paragraph num="(4)"> <text>Opiates;</text> </paragraph> <paragraph num="(5)"> <text>Alcohol;</text> </paragraph> <paragraph num="(6)"> <text>Methadone or buprenorphine, whichever is appropriate; and</text> </paragraph> <paragraph num="(7)"> <text>Oxycodone;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Develops a taper schedule at least 21 days long with daily dosage reductions less than 5 percent of the original total dose, regardless of the patient’s ability to pay;</text> </paragraph> <paragraph num="J."> <text>Nonvoluntarily tapers or transfers a patient only if the:</text> <paragraph num="(1)"> <text>Patient’s behavior on program premises is abusive, violent, or illegal;</text> </paragraph> <paragraph num="(2)"> <text>Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions, including taper;</text> </paragraph> <paragraph num="(3)"> <text>Patient misses 3 consecutive medication days, and the program physician, after reevaluation, has determined that nonvoluntary taper is warranted; or</text> </paragraph> <paragraph num="(4)"> <text>Clinical staff documents therapeutic reasons for taper, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Requires that a patient show evidence of the availability of locked storage before a patient may take home any dose of medication; and</text> </paragraph> <paragraph num="L."> <text>Provides clinical services addressing any substance-use disorders to each patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Mobile Crisis Team Programs."> <paragraph num="A."> <text>Definition.</text> <paragraph num="(1)"> <text>In this regulation, the following term has the meaning indicated.</text> </paragraph> <paragraph num="(2)"> <text>Term Defined. “Program” means the site and service combination which is recognized through licensure to offer an organized system of activities performed for the benefit of persons served.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In order to be licensed under this subtitle, a mobile crisis team within a mobile crisis team program shall:</text> <paragraph num="(1)"> <text>Meet the requirements of COMAR 10.63.01, 10.63.02, and 10.63.06 and this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Provide, 24 hours per day, 7 days per week, 365 days per year, professional intervention for children or adults whose behaviors are consistent with experiencing:</text> <paragraph num="(a)"> <text>A mental health crisis;</text> </paragraph> <paragraph num="(b)"> <text>A substance use disorder crisis; or</text> </paragraph> <paragraph num="(c)"> <text>Both §B(2)(a) and (b) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Meet the requirements defined in Health-General Article, Title 10, Subtitle 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Be pre-approved by the Department or its designee to participate in the public behavioral health system to receive funding through the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Respond to urgent symptoms or behaviors that are disrupting an individual’s behavioral health functioning.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Mobile crisis team response may also include engaging law-enforcement where the addition of a law enforcement presence provides additional safety measures, when indicated, for all individuals involved in the mobile crisis intervention.</text> </paragraph> <paragraph num="D."> <text>Mobile Crisis Team Program Services. A mobile crisis team program shall provide the following services:</text> <paragraph num="(1)"> <text>In-person, community-based professional and peer intervention services which shall:</text> <paragraph num="(a)"> <text>Be age and culturally appropriate, and explained in terms understandable to the individual;</text> </paragraph> <paragraph num="(b)"> <text>Be designed to:</text> <paragraph num="(i)"> <text>De-escalate an individual’s behavioral health crisis;</text> </paragraph> <paragraph num="(ii)"> <text>Evaluate the nature of the crisis;</text> </paragraph> <paragraph num="(iii)"> <text>Stabilize the individual to the pre-crisis level of functioning; and</text> </paragraph> <paragraph num="(iv)"> <text>Maintain continuity of care by coordinating access to various treatment and support services;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Be deployed to the location of an individual in crisis;</text> </paragraph> <paragraph num="(d)"> <text>Address immediate dynamics that may be contributing to the crisis;</text> </paragraph> <paragraph num="(e)"> <text>Include a response initiated by a mobile crisis team within an average of 60 to 120 minutes of determining an individual is in need of crisis intervention;</text> </paragraph> <paragraph num="(f)"> <text>Use evidence-based tools to screen, assess, stabilize, and refer persons, as clinically indicated;</text> </paragraph> <paragraph num="(g)"> <text>Be provided by a mobile crisis team that is nearest to the location of the individual in crisis; and</text> </paragraph> <paragraph num="(h)"> <text>Be provided under the documented supervision of a licensed mental health professional approved by the appropriate board to supervise.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Crisis Intervention Services. A mobile crisis team program shall provide medically necessary crisis intervention services, inclusive of the following:</text> <paragraph num="(a)"> <text>Triage and screening to determine the level of risk faced by the individual in crisis and assess the most appropriate response;</text> </paragraph> <paragraph num="(b)"> <text>An immediate assessment conducted by a licensed mental health professional to determine the services necessary to stabilize the crisis for the individual;</text> </paragraph> <paragraph num="(c)"> <text>A plan for de-escalation and resolution of the crisis, including in-person interventions for immediate de-escalation of presenting behavioral symptoms;</text> </paragraph> <paragraph num="(d)"> <text>Brief therapeutic and skill-building interventions and therapeutic counseling techniques specific to the crisis that aims to lower risks and resolve the crisis so that a higher level of care is not needed;</text> </paragraph> <paragraph num="(e)"> <text>Case management and care coordination services, which may include referrals to other services as well as follow-up contacts;</text> </paragraph> <paragraph num="(f)"> <text>Engaging peer and natural and family support when appropriate;</text> </paragraph> <paragraph num="(g)"> <text>A safety crisis plan, which shall aim to keep an individual in crisis and their environment safe and may include the distribution of opioid overdose reversal drugs, lethal means counseling, and other evidence-based interventions;</text> </paragraph> <paragraph num="(h)"> <text>Stabilization services to ensure the individual’s safety and connection to needed resources to reduce the behavioral symptoms leading to crisis; and</text> </paragraph> <paragraph num="(i)"> <text>Follow-up screening and assessment for ongoing risk when indicated by the needs of persons served, in-person, via phone, or via telehealth following the initial crisis intervention.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Follow-up services, provided in-person, via phone, or via telehealth, which shall include, but are not limited to:</text> <paragraph num="(a)"> <text>Referral and linkage with other service providers; and</text> </paragraph> <paragraph num="(b)"> <text>Ongoing coordination to meet identified resource needs.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Mobile Crisis Team Program Staffing. A mobile crisis team program shall include at least one licensed mental health professional available at all times, either via telehealth or face-to-face, who is:</text> <paragraph num="(1)"> <text>Licensed at the independent practice level;</text> </paragraph> <paragraph num="(2)"> <text>Eligible to oversee the staff of the team; and</text> </paragraph> <paragraph num="(3)"> <text>Eligible to complete an emergency petition.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A mobile crisis team:</text> <paragraph num="(1)"> <text>Shall include two staff members responding in-person;</text> </paragraph> <paragraph num="(2)"> <text>Shall include a licensed mental health professional face-to-face or via telehealth; and</text> </paragraph> <paragraph num="(3)"> <text>May not include law enforcement, if present, as part of the two-person response team.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Mobile Crisis Team Program Staff Training Requirements.</text> <paragraph num="(1)"> <text>All mobile crisis team program staff shall complete required trainings approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>A mobile crisis team program shall have a training and competency plan in place that:</text> <paragraph num="(a)"> <text>Is reviewed annually;</text> </paragraph> <paragraph num="(b)"> <text>Is consistent with:</text> <paragraph num="(i)"> <text>Accreditation requirements; and</text> </paragraph> <paragraph num="(ii)"> <text>Requirements published by the Department;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Defines the core competencies needed to provide reliable and high-quality care for each clinical discipline, within their scope of practice, as a staff member of a mobile crisis team; and</text> </paragraph> <paragraph num="(d)"> <text>Ensures that all staff receive competency verification following all initial and ongoing training.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All mobile crisis teams shall be trained in the mobile response and stabilization services (MRSS) model.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Mobile Crisis Team Program Reporting Requirements. A mobile crisis team program shall provide data on outcomes and social determinants of care to the State in the format and frequency required by the Department.</text> </paragraph> <paragraph num="I."> <text>A mobile crisis team program shall obtain pre-approval from the Department and LBHA or CSA to operate mobile crisis services in the PBHS to ensure services meet local community needs for behavioral health crisis services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Behavioral Health Crisis Stabilization Center (BHCSC) Program."> <paragraph num="A."> <text>Definition.</text> <paragraph num="(1)"> <text>In this regulation, the following term has the meaning indicated.</text> </paragraph> <paragraph num="(2)"> <text>Term Defined. “Program” means the site and service combination which:</text> <paragraph num="(a)"> <text>Is recognized through licensure to offer an organized system of activities to provide an alternative to emergency departments for behavioral health crisis care, emergency petition assessment, and avoidable inpatient or carceral engagement; and</text> </paragraph> <paragraph num="(b)"> <text>Serves as a critical access point for individuals experiencing a mental health, substance use disorder, substance use related, or combined crisis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>In order to be licensed under this subtitle, a BHCSC program shall:</text> <paragraph num="(1)"> <text>Meet the requirements of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Meet the requirements of Health-General Article, Title 10, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Meet the requirements of COMAR 10.63.01—10.63.06; and</text> </paragraph> <paragraph num="(4)"> <text>Be pre-approved by the Department or its designee to receive PBHS funding before participating in the PBHS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>BHCSC Program Services. The BHCSC program shall:</text> <paragraph num="(1)"> <text>Provide crisis response services as outlined in Health-General Article, Title 10, Subtitle 14, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Process involuntary admissions according to Health-General Article, §§10-613—10-621, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Provide BHCSC services 24 hours a day, 7 days a week, 365 days a year;</text> </paragraph> <paragraph num="(4)"> <text>Initiate triage upon patient arrival and deliver this service in a manner that aligns with best practice and makes reasonable efforts to minimize time on-site at the BHCSC for law enforcement or other first responders;</text> </paragraph> <paragraph num="(5)"> <text>Use evidence-based tools to screen, assess, stabilize, and refer persons, as clinically indicated;</text> </paragraph> <paragraph num="(6)"> <text>Provide medical screening at triage for the presence of any condition of sufficient severity to require transfer to an appropriate facility for immediate medical or surgical care;</text> </paragraph> <paragraph num="(7)"> <text>Provide active acute mental health and substance use disorder crisis intervention and stabilization services in a BHCSC setting that is not in the Health Services Cost Review Commission regulated space of a hospital, for children, adolescents, and adults whose behaviors are consistent with experiencing:</text> <paragraph num="(a)"> <text>A mental health crisis;</text> </paragraph> <paragraph num="(b)"> <text>A substance use disorder crisis; or</text> </paragraph> <paragraph num="(c)"> <text>Both §C(7)(a) and (b) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Provide assessment, counseling, de-escalation, and safety planning;</text> </paragraph> <paragraph num="(9)"> <text>Initiate, maintain, and prescribe psychotropic and somatic medications as appropriate, including:</text> <paragraph num="(a)"> <text>PRN intramuscular medication;</text> </paragraph> <paragraph num="(b)"> <text>Long-acting injectable antipsychotic medication;</text> </paragraph> <paragraph num="(c)"> <text>Medications used for withdrawal management; and</text> </paragraph> <paragraph num="(d)"> <text>Medications for Opioid Use Disorder;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Provide withdrawal management services for all substances; and</text> </paragraph> <paragraph num="(11)"> <text>Maintain compliance with the model program structure and facility standards designed by the Department, as required by Health-General Article, §10-621, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>BHCSC Staffing Requirements.</text> <paragraph num="(1)"> <text>A BHCSC program shall designate a program director who is a licensed mental health professional operating at the independent level of practice who shall be responsible for the overall management and operation of the BHCSC and whose qualifications and duties are defined in the individual’s job description. The job description shall ensure that other job responsibilities will not impede the operation and administration of the BHCSC.</text> </paragraph> <paragraph num="(2)"> <text>A BHCSC program shall have a nursing manager who is a registered nurse.</text> </paragraph> <paragraph num="(3)"> <text>A BHCSC program shall continuously employ an adequate number of staff and ensure an appropriate staff composition are on-site to:</text> <paragraph num="(a)"> <text>Carry out the BHCSC program’s services, goals, and objectives; and</text> </paragraph> <paragraph num="(b)"> <text>Ensure the continuous provision of sufficient supervision and monitoring of individuals receiving crisis stabilization services.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A BHCSC program shall employ a qualified prescriber or prescribers who are authorized to prescribe medications by the Maryland Board of Physicians or the Maryland Board of Nursing to provide general medical services and prescription of medications and treatment, and who shall:</text> <paragraph num="(a)"> <text>Be available 24 hours per day;</text> </paragraph> <paragraph num="(b)"> <text>Make daily rounds, including in-person reassessment, to any individual who has been emergency petitioned and remains in the BHCSC for more than 24 hours; and</text> </paragraph> <paragraph num="(c)"> <text>Be approved by the Department if the qualified prescriber is not a psychiatrist or a psychiatric nurse practitioner.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A physician shall be on call at all times for the provision of those BHCSC services that may only be provided by a physician.</text> </paragraph> <paragraph num="(6)"> <text>There shall be a minimum of one registered nurse on site at all times.</text> </paragraph> <paragraph num="(7)"> <text>There shall be additional staff, including mental health professionals, on-site at all times to provide active crisis intervention to ensure BHCSC services are provided by personnel within their scope of practice and with expertise appropriate to the service recipient's needs.</text> </paragraph> </paragraph> <paragraph num="E."> <text>BHCSC Staffing Plan.</text> <paragraph num="(1)"> <text>A BHCSC program shall develop and maintain a written staffing plan designed to ensure sufficient coverage, discipline mix, service quality, and safety and which shall:</text> <paragraph num="(a)"> <text>Outline the qualifications and duties of each staff position; and</text> </paragraph> <paragraph num="(b)"> <text>Be approved by the Department at the time of licensure.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A BHCSC program shall notify the Department of any changes in staffing composition, or an addition or reduction in staffing numbers that varies from the approved staffing plan by greater than 10 percent.</text> </paragraph> </paragraph> <paragraph num="F."> <text>BHCSC Program Quality Assurance and Reporting.</text> <paragraph num="(1)"> <text>A BHCSC program shall begin assessment and active treatment immediately upon a patient’s admission.</text> </paragraph> <paragraph num="(2)"> <text>A BHCSC program shall ensure that, within 60 minutes or less of the individual’s arrival, a registered nurse initiates an in-person nursing assessment and physical exam in collaboration with the approved physician or psychiatric nurse practitioner, and develops and implements an initial treatment plan for services in the BHCSC.</text> </paragraph> <paragraph num="(3)"> <text>A BHCSC mental health professional shall provide a crisis assessment at the earliest opportunity.</text> </paragraph> <paragraph num="(4)"> <text>For individuals in the BHCSC under an emergency petition with stays beyond 24 hours, BHCSC mental health professional staff shall perform, at a minimum, daily in-person reassessment.</text> </paragraph> <paragraph num="(5)"> <text>Crisis assessments shall be staffed with the approved physician or psychiatric nurse practitioner.</text> </paragraph> <paragraph num="(6)"> <text>An approved physician or psychiatric nurse practitioner shall review and sign off on every discharge plan for individuals receiving services in the BHCSC.</text> </paragraph> <paragraph num="(7)"> <text>An initial evaluation by an approved physician or psychiatric nurse practitioner shall be completed at the earliest reasonable opportunity, which shall be no later than 4 hours after admission, either in-person or via telehealth, and include the following:</text> <paragraph num="(a)"> <text>A medical evaluation;</text> </paragraph> <paragraph num="(b)"> <text>Assessment of suicide, homicide, violence, and other risk factors; and</text> </paragraph> <paragraph num="(c)"> <text>Review and authorization of the BHCSC initial crisis intervention care plans.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A BHCSC program shall maintain relationships with existing community behavioral health service providers who may receive referrals from the BHCSC, which shall include written referral agreements with the following:</text> <paragraph num="(a)"> <text>Outpatient community behavioral health providers;</text> </paragraph> <paragraph num="(b)"> <text>Hospital psychiatric units;</text> </paragraph> <paragraph num="(c)"> <text>Residential crisis programs;</text> </paragraph> <paragraph num="(d)"> <text>Respite programs;</text> </paragraph> <paragraph num="(e)"> <text>Residential substance use treatment programs; and</text> </paragraph> <paragraph num="(f)"> <text>Providers of medications for opioid use disorders.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A BHCSC program shall make documented attempts to contact and follow up with all individuals discharged to a community setting and, for individuals who received outpatient services and who initially presented or were later evaluated as a danger to self or others, follow up within 72 hours after discharge from the BHCSC.</text> </paragraph> <paragraph num="(10)"> <text>A BHCSC program shall have protocols, which may include referral agreements with other programs, that provide for admission and treatment of individuals with:</text> <paragraph num="(a)"> <text>Limited English proficiency;</text> </paragraph> <paragraph num="(b)"> <text>Hearing and speaking disabilities; and</text> </paragraph> <paragraph num="(c)"> <text>Physical, developmental, and intellectual disabilities.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>A BHCSC program shall develop and maintain written triage policies and procedures approved by the Department, including ability to accept and provide services to individuals under an emergency petition and individuals referred by 9-8-8 and other local crisis hotlines.</text> </paragraph> <paragraph num="(12)"> <text>A BHCSC program shall notify the Department and LBHA, in a form and manner determined by the Department, of the following:</text> <paragraph num="(a)"> <text>Initiation of diversion status for the BHCSC program; and</text> </paragraph> <paragraph num="(b)"> <text>Diversion of any individual on an emergency petition.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>A BHCSC program shall maintain a referral log that includes documentation and rationale for individuals not accepted for admission or transfer to the BHCSC, and make this available to the Department upon request.</text> </paragraph> <paragraph num="(14)"> <text>A BHCSC program shall develop, implement, and maintain written policies and procedures in place to ensure the safety of all individuals, regardless of age.</text> </paragraph> <paragraph num="(15)"> <text>A BHCSC program shall provide data to support quality assurance and improvement initiatives to the State in the format and frequency requested by the Department.</text> </paragraph> </paragraph> <paragraph num="G."> <text>BHCSC Program Staff Training Requirements.</text> <paragraph num="(1)"> <text>BHCSC program staff shall complete required trainings approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>A BHCSC program shall have a training and competency plan in place that:</text> <paragraph num="(a)"> <text>Is reviewed annually;</text> </paragraph> <paragraph num="(b)"> <text>Is consistent with:</text> <paragraph num="(i)"> <text>Accreditation requirements; and</text> </paragraph> <paragraph num="(ii)"> <text>Requirements published by the Department;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Defines the core competencies needed to provide reliable and high-quality care for each clinical discipline within their scope of practice as a part of the BHCSC program; and</text> </paragraph> <paragraph num="(d)"> <text>Ensures that all staff receive needed training and competency verification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Clinical Record Documentation. A BHCSC program shall maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, includes:</text> <paragraph num="(1)"> <text>The date or dates of service within the BHCSC, including triage and discharge times;</text> </paragraph> <paragraph num="(2)"> <text>The individual’s presenting problems or reason for the BHCSC admission;</text> </paragraph> <paragraph num="(3)"> <text>A brief description of services provided, including progress notes;</text> </paragraph> <paragraph num="(4)"> <text>An official e-Signature, or a legible signature, along with the printed or typed name, and appropriate title of each individual providing services;</text> </paragraph> <paragraph num="(5)"> <text>Documentation of risk assessments;</text> </paragraph> <paragraph num="(6)"> <text>Documentation of medication evaluation and management throughout the stabilization period;</text> </paragraph> <paragraph num="(7)"> <text>Crisis assessment or assessments by the mental health professional staff; and</text> </paragraph> <paragraph num="(8)"> <text>A crisis discharge plan for each individual, which shall indicate the referrals and other activities intended to maintain stabilization.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Seclusion and Restraint.</text> <paragraph num="(1)"> <text>A BHCSC program shall have the capacity for both seclusion and restraint. For purposes of this regulation:</text> <paragraph num="(a)"> <text>Seclusion has the meaning set forth in 42 CFR §482.13(e)(1)(ii); and</text> </paragraph> <paragraph num="(b)"> <text>Restraint has the meaning set forth in 42 CFR §482.13(e)(1)(i).</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A BHCSC program shall be compliant with State and federal seclusion and restraint regulations and laws, including 42 CFR §482.13 and Health-General Article, §10-701, Annotated Code of Maryland, and any successor laws and regulations.</text> </paragraph> <paragraph num="(3)"> <text>Application of seclusion or restraint within a BHCSC program requires:</text> <paragraph num="(a)"> <text>Use as a last resort, only after less restrictive interventions have been considered or tried, unless the emergency nature of the situation precludes the latter, and</text> </paragraph> <paragraph num="(b)"> <text>An order from an approved physician or other clinician permitted by law, with exceptions noted for an emergency as outlined in §I(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Seclusion and restraint may be initiated by a registered nurse, if a physician or other clinician permitted by law is not present and an emergency situation warrants immediate seclusion or restraint, in which case:</text> <paragraph num="(a)"> <text>BHCSC staff shall obtain an order as soon as possible, but no later than within 1 hour; and</text> </paragraph> <paragraph num="(b)"> <text>A clinical assessment by a psychiatrist or psychiatric nurse practitioner shall occur within 1 hour of initiation or renewal by a registered nurse.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An order for seclusion or restraint may not exceed 4 hours for adults, 2 hours for youth 9 years old or older, and 1 hour for children younger than 9 years old. Such an order does not require continuation of the seclusion or restraint for the entire time specified by the order. The seclusion or restraint shall be discontinued as soon as clinically indicated.</text> </paragraph> <paragraph num="(6)"> <text>An individual in seclusion or restraint shall be maintained on 1:1 observation the entire time the individual is secluded or restrained to protect them from harm.</text> </paragraph> <paragraph num="(7)"> <text>Restraint and seclusion shall never occur simultaneously for an individual.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Environmental/Life Safety Requirements.</text> <paragraph num="(1)"> <text>A BHCSC program shall:</text> <paragraph num="(a)"> <text>Provide a comfortable, furnished admission pre-triage waiting area for individuals who voluntarily present;</text> </paragraph> <paragraph num="(b)"> <text>Provide a locked and secure dedicated drop-off admission space, designed to accommodate those individuals who have been emergency petitioned;</text> </paragraph> <paragraph num="(c)"> <text>Provide a comfortable, furnished waiting area for individuals accompanying participants in the BHCSC program;</text> </paragraph> <paragraph num="(d)"> <text>Allow for continual visual observation and monitoring of individuals being served;</text> </paragraph> <paragraph num="(e)"> <text>Ensure a safe environment of care for a participant younger than 18 years old by having a separation from adults, with appropriate staff maintaining an adequate level of supervision;</text> </paragraph> <paragraph num="(f)"> <text>Ensure that the 23-hour crisis BHCSC shall have at least one locked door seclusion room, which:</text> <paragraph num="(i)"> <text>Shall be a minimum of 80 square feet;</text> </paragraph> <paragraph num="(ii)"> <text>Allows for continual visual observation and monitoring that allows for immediate emergency response; and</text> </paragraph> <paragraph num="(iii)"> <text>Uses a locking mechanism consistent with National Fire Protection Association (NFPA) standards for the facility; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Ensure that there is at least one quiet room that is separate from the seclusion room and remains unlocked whenever in use.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department may require the BHCSC program to add additional seclusion or quiet rooms, based on the intended capacity of the BHCSC Program.</text> </paragraph> <paragraph num="(3)"> <text>The BHCSC program facility shall be free from fire hazards and have:</text> <paragraph num="(a)"> <text>Adequate smoke detectors;</text> </paragraph> <paragraph num="(b)"> <text>Working and updated fire extinguishers;</text> </paragraph> <paragraph num="(c)"> <text>Fire sprinklers as required by law;</text> </paragraph> <paragraph num="(d)"> <text>A written fire evacuation plan; and</text> </paragraph> <paragraph num="(e)"> <text>A current fire inspection certification.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The BHCSC program shall conduct and document an annual environmental safety review and take actions to replace items that create an unnecessary risk of self-harm with safer items designed for behavioral health settings, including, but not limited to:</text> <paragraph num="(a)"> <text>Anchor points;</text> </paragraph> <paragraph num="(b)"> <text>Door handles;</text> </paragraph> <paragraph num="(c)"> <text>Curtains;</text> </paragraph> <paragraph num="(d)"> <text>Hooks; and</text> </paragraph> <paragraph num="(e)"> <text>Shower rods and curtains.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The BHCSC program shall comply with applicable federal, State, and local sanitation, building, fire codes, and zoning requirements.</text> </paragraph> <paragraph num="(6)"> <text>The BHCSC program shall maintain documentation of legally and accreditation required periodic evacuation drills.</text> </paragraph> <paragraph num="(7)"> <text>The BHCSC program shall have:</text> <paragraph num="(a)"> <text>Bathrooms;</text> </paragraph> <paragraph num="(b)"> <text>Telephones;</text> </paragraph> <paragraph num="(c)"> <text>An automated external defibrillator; and</text> </paragraph> <paragraph num="(d)"> <text>Confidential office space for treatment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="K."> <text>BHCSC Dietary Services. BHCSC program dietary services shall be as follows:</text> <paragraph num="(1)"> <text>At least three meals plus an evening snack provided daily with no more than 14 hours between any two meals;</text> </paragraph> <paragraph num="(2)"> <text>Dietary services shall comply with applicable local, State, and federal laws;</text> </paragraph> <paragraph num="(3)"> <text>A BHCSC program shall have a written plan describing the organization and delivery of dietary services; and</text> </paragraph> <paragraph num="(4)"> <text>A dietitian licensed under Health Occupations Article, §5-101, Annotated Code of Maryland, shall develop and implement the dietary service plan.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Infection Control — Universal Precautions. A BHCSC program shall observe universal precautions as required under COMAR 10.52.11 as applicable to health care facilities.</text> </paragraph> <paragraph num="M."> <text>Site Inspection. At a minimum, an annual site inspection of each BHCSC shall be conducted by the assigned LBHA.</text> </paragraph> <paragraph num="N."> <text>Required Management Staff. The required staff in a BHCSC program, as defined in subsection §D of this regulation and COMAR 10.63.01, and subject to the requirements for reporting of vacancies under COMAR 10.63.01.05, includes:</text> <paragraph num="(1)"> <text>Program director;</text> </paragraph> <paragraph num="(2)"> <text>Medical director;</text> </paragraph> <paragraph num="(3)"> <text>Nurse manager; and</text> </paragraph> <paragraph num="(4)"> <text>Mental health professionals in the event that the vacancy leads to an inability to meet the staffing requirements of the regulation.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, and 10-1402, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19J amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 adopted effective May 27, 2024 (51:10 Md. R. 526)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 adopted effective May 27, 2024 (51:10 Md. R. 526)</annotation> </annotations> </chapter> <chapter num="04" heading="Additional Requirements for Accreditation-Based Licenses for Specific Residential Community-Based Behavioral Health Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth descriptions of, criteria for, and licensing requirements for, three specific programs that provide residential community-based behavioral health services. These programs shall comply with COMAR 10.63.01—.02, 10.63.04, and 10.63.06. Residential Rehabilitation Programs shall also comply with COMAR 10.63.03.09.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Covered Programs."> <text>This chapter applies to the following programs:</text> <paragraph num="A."> <text>Group Homes for Adults with Mental Illness;</text> </paragraph> <paragraph num="B."> <text>Residential Crisis Services (RCS) program; and</text> </paragraph> <paragraph num="C."> <text>Residential Rehabilitation Program (RRP).</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Group Homes for Adults with Mental Illness."> <paragraph num="A."> <text>In order to be licensed under this subtitle, a group home for adults with mental illness shall:</text> <paragraph num="(1)"> <text>Meet the definition in Health-General Article, §10-514 (b), (d), and (e), Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Provide a home-like, supportive residential environment:</text> <paragraph num="(a)"> <text>In a small group home, which provides services for more than 3, but not more than 8 individuals with a mental health disorder; or</text> </paragraph> <paragraph num="(b)"> <text>In a large group home for more than 8, but not more than 16 individuals with a mental health disorder; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Meet the site requirements set out in Regulation .07 of this chapter verified through an annual site inspection conducted by the CSA or LBHA.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A group home for adults with mental illness may not provide services for individuals with a primary diagnosis of developmental disability, as defined in Health-General Article, §7-101, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Residential Crisis Services (RCS)."> <text>In order to be licensed under this subtitle, a residential crisis services program:</text> <paragraph num="A."> <text>Shall provide short-term mental health treatment and support services in a structured environment for individuals who require 24-hour supervision due to a psychiatric crisis;</text> </paragraph> <paragraph num="B."> <text>Shall be designed to:</text> <paragraph num="(1)"> <text>Prevent psychiatric inpatient admission;</text> </paragraph> <paragraph num="(2)"> <text>Shorten the length of inpatient stay;</text> </paragraph> <paragraph num="(3)"> <text>Effectively use general hospital emergency departments; and</text> </paragraph> <paragraph num="(4)"> <text>Provide an alternative to psychiatric inpatient admission;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Shall have staff who are on-site 24 hours per day, 7 days per week, whenever an individual is on-site receiving services;</text> </paragraph> <paragraph num="D."> <text>For adults, shall meet the site requirements set out in Regulation .07 of this chapter verified through an annual site inspection conducted by the CSA or LBHA; and</text> </paragraph> <paragraph num="E."> <text>For individuals younger than 21 years old, may offer services in an appropriately licensed therapeutic program, as appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Residential Rehabilitation Program (RRP)."> <text>In order to be licensed under this subtitle, a residential rehabilitation program (RRP) shall:</text> <paragraph num="A."> <text>Serve individuals with a mental disorder;</text> </paragraph> <paragraph num="B."> <text>Be operated by a licensed PRP-A;</text> </paragraph> <paragraph num="C."> <text>Lease or own the RRP sites;</text> </paragraph> <paragraph num="D."> <text>Be approved by BHA for RRP funding;</text> </paragraph> <paragraph num="E."> <text>Provide a home-like, supportive residential environment;</text> </paragraph> <paragraph num="F."> <text>Provide services for no more than 3 individuals per RRP site, unless also licensed as a group home as provided in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="G."> <text>Promote the individual’s ability to engage and participate in appropriate community activities;</text> </paragraph> <paragraph num="H."> <text>Enable the individual to develop the daily living skills needed for independent functioning;</text> </paragraph> <paragraph num="I."> <text>Have:</text> <paragraph num="(1)"> <text>On-site staffing, as needed to meet the needs of the individuals served; and</text> </paragraph> <paragraph num="(2)"> <text>Staff that are available on call, 24 hours per day, 7 days per week;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Meet the site requirements as set out in Regulation .07 of this chapter, verified through an annual site inspection conducted by the CSA or LBHA, as appropriate;</text> </paragraph> <paragraph num="K."> <text>Have a written policy regarding the development of and process for implementation of a managed intervention plan (MIP) for an individual receiving residential services who may be at risk of an unplanned discharge, which:</text> <paragraph num="(1)"> <text>Is developed in collaboration with the individual, treatment team members, and CSA or LBHA, as appropriate; and</text> </paragraph> <paragraph num="(2)"> <text>Includes a description of additional individualized services and supports that may be needed, and identification of temporary residential alternatives, if any; and</text> </paragraph> </paragraph> <paragraph num="L."> <text>If an MIP is executed, develop a transition plan that:</text> <paragraph num="(1)"> <text>Is created in collaboration with the individual, treatment team members, CSA or LBHA, as appropriate, and ASO; and</text> </paragraph> <paragraph num="(2)"> <text>Includes the elements outlined in §K(2) of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application Requirements for a Residence to be Operated by a Program."> <text>A program seeking a license under this subtitle for a residential site shall submit to the CSA or LBHA a completed application that:</text> <paragraph num="A."> <text>Is on the form required by the Administration with all required documents attached; and</text> </paragraph> <paragraph num="B."> <text>Includes documentation that the residence:</text> <paragraph num="(1)"> <text>Is owned or leased by the applicant; or</text> </paragraph> <paragraph num="(2)"> <text>Will be owned or leased by the applicant; and</text> </paragraph> <paragraph num="(3)"> <text>Is located in a building that will have continuous fire, liability, and hazard insurance coverage.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Residential Site Requirements."> <text>A program licensed to provide community-based behavioral health residential services under this chapter shall ensure that:</text> <paragraph num="A."> <text>All areas of a residence, including storage areas:</text> <paragraph num="(1)"> <text>Are safe;</text> </paragraph> <paragraph num="(2)"> <text>Clean; and</text> </paragraph> <paragraph num="(3)"> <text>Free of hazards and clutter;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A residence has:</text> <paragraph num="(1)"> <text>No housing code or zoning violations;</text> </paragraph> <paragraph num="(2)"> <text>Working smoke alarms or smoke detectors that meet local fire codes for residential dwellings;</text> </paragraph> <paragraph num="(3)"> <text>Hot and cold running water:</text> </paragraph> <paragraph num="(4)"> <text>Adequate light, heat, and ventilation; and</text> </paragraph> <paragraph num="(5)"> <text>Sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils comparable to those found in the residences of nondisabled individuals;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each resident:</text> <paragraph num="(1)"> <text>Has the resources to purchase or has access to food;</text> </paragraph> <paragraph num="(2)"> <text>Has the resources to acquire an adequate supply of soap, towels, and toilet tissue;</text> </paragraph> <paragraph num="(3)"> <text>Who self-administers medication, has access to a secure storage area for the resident’s medications;</text> </paragraph> <paragraph num="(4)"> <text>Has access to a secure storage area for funds and valuables;</text> </paragraph> <paragraph num="(5)"> <text>Has access to transportation;</text> </paragraph> <paragraph num="(6)"> <text>Has access to a telephone in the residence; and</text> </paragraph> <paragraph num="(7)"> <text>To the extent possible, may use personal possessions and preferences in furnishing and decorating the resident’s space.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The following emergency procedures are followed:</text> <paragraph num="(1)"> <text>Posted near the telephone are telephone numbers for the:</text> <paragraph num="(a)"> <text>Fire department, police, ambulance, and poison control center; and</text> </paragraph> <paragraph num="(b)"> <text>Program’s on-call staff; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An emergency evacuation procedure that is explained to and practiced by residents within 10 days after entering residence and, at a minimum, every 3 months after that;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Each bedroom has:</text> <paragraph num="(1)"> <text>A minimum of 70 square feet for a single bedroom and a minimum of 120 square feet for a double bedroom;</text> </paragraph> <paragraph num="(2)"> <text>An interior door, except for an efficiency apartment;</text> </paragraph> <paragraph num="(3)"> <text>Closet space in or convenient to each bedroom for each individual using the bedroom;</text> </paragraph> <paragraph num="(4)"> <text>Coverings for each window, for privacy;</text> </paragraph> <paragraph num="(5)"> <text>A bed with a clean mattress and pillow for each resident using the bedroom;</text> </paragraph> <paragraph num="(6)"> <text>At least two sets of bed linens per resident; and</text> </paragraph> <paragraph num="(7)"> <text>Not more than two residents using the bedroom;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Each toilet and bathing area has:</text> <paragraph num="(1)"> <text>A minimum of one full bathroom for every four residents; and</text> </paragraph> <paragraph num="(2)"> <text>At least one toilet, one basin, and one tub or shower connected to hot and cold water;</text> </paragraph> <paragraph num="(3)"> <text>Easy access and conveniently located, not more than one floor level from living, dining, and sleeping rooms; and</text> </paragraph> <paragraph num="(4)"> <text>Privacy for the individual using it; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>The program has a written relocation plan for each site that:</text> <paragraph num="(1)"> <text>Specifies where residents may live temporarily if the CSA or LBHA determines that conditions in the approved residence pose an imminent risk to the health, safety, or welfare of a resident;</text> </paragraph> <paragraph num="(2)"> <text>Is approved by the CSA or LBHA, as appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>Is updated annually.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 255)</annotation> </annotations> </chapter> <chapter num="05" heading="Descriptions and Criteria for Programs Requiring a Non-Accreditation-Based License"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the descriptions of, and the criteria for, community behavioral health programs that are permitted to operate in Maryland so long as they have valid and current non-accreditation-based licenses under this subtitle. The program shall also meet the requirements of COMAR 10.63.01, 10.63.05—10.63.06.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for Non-Accreditation Based Licenses."> <text>To operate in Maryland, the programs described in this chapter shall have a valid and current non-accreditation-based license to provide community-based behavioral health services.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Covered Programs."> <text>This chapter applies to the following programs:</text> <paragraph num="A."> <text>Substance-Related Disorder Assessment and Referral Program;</text> </paragraph> <paragraph num="B."> <text>DUI Education Program; and</text> </paragraph> <paragraph num="C."> <text>Early Intervention Level 0.5 programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Substance-Related Disorder Assessment and Referral Program."> <text>To be licensed under this subtitle, a substance-related disorder assessment and referral program shall:</text> <paragraph num="A."> <text>Be operated by a State or local government entity;</text> </paragraph> <paragraph num="B."> <text>Provide a comprehensive assessment of an individual’s current status and relevant history in the following areas:</text> <paragraph num="(1)"> <text>Alcohol, tobacco, and other drug use (ATOD);</text> </paragraph> <paragraph num="(2)"> <text>Employment or financial support;</text> </paragraph> <paragraph num="(3)"> <text>Gambling behavior;</text> </paragraph> <paragraph num="(4)"> <text>ATOD and gambling treatment history;</text> </paragraph> <paragraph num="(5)"> <text>Mental health;</text> </paragraph> <paragraph num="(6)"> <text>Legal involvement;</text> </paragraph> <paragraph num="(7)"> <text>Family and social systems;</text> </paragraph> <paragraph num="(8)"> <text>Educational involvement; and</text> </paragraph> <paragraph num="(9)"> <text>Somatic health, including a review of medication;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Diagnose behavioral health disorders;</text> </paragraph> <paragraph num="D."> <text>Determine type and intensity of services needed for behavioral health disorders;</text> </paragraph> <paragraph num="E."> <text>Refer to behavioral health services programs and other services as determined by assessment with appropriate follow-up; and</text> </paragraph> <paragraph num="F."> <text>Have clinical staff authorized under the Health Occupations Article to provide the service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="DUI Education Program."> <text>To be licensed under this subtitle, a DUI education program shall:</text> <paragraph num="A."> <text>Provide services to individuals convicted under Transportation Article, §21-902, Annotated Code of Maryland, and ordered under Criminal Procedure Article, §6-219, to attend an education program;</text> </paragraph> <paragraph num="B."> <text>Provide a comprehensive assessment, unless the participant has received an assessment by a licensed or certified clinician, or licensed program within the preceding 45 days, of a participant’s current status and relevant history in the following areas:</text> <paragraph num="(1)"> <text>Alcohol, tobacco, and other drug use (ATOD);</text> </paragraph> <paragraph num="(2)"> <text>Employment or financial support;</text> </paragraph> <paragraph num="(3)"> <text>Gambling behavior;</text> </paragraph> <paragraph num="(4)"> <text>ATOD and gambling treatment history;</text> </paragraph> <paragraph num="(5)"> <text>Mental health;</text> </paragraph> <paragraph num="(6)"> <text>Legal involvement;</text> </paragraph> <paragraph num="(7)"> <text>Family and social systems;</text> </paragraph> <paragraph num="(8)"> <text>Educational involvement; and</text> </paragraph> <paragraph num="(9)"> <text>Somatic health, including a review of medications;</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the assessment determines that referral to a treatment program or other indicated service is necessary, make the referral and notify the court of the results of the assessment;</text> </paragraph> <paragraph num="D."> <text>Require participants to successfully complete, at a minimum, six weekly, 2-hour sessions for a total of 12 hours;</text> </paragraph> <paragraph num="E."> <text>Have instructors who, at a minimum, are certified as a Certified Supervised Counselor—Alcohol and Drug, as defined by Health Occupations Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="F."> <text>Teach the Administration’s curriculum or an equivalent curriculum approved by the Department, which covers:</text> <paragraph num="(1)"> <text>Scope of the drinking-driver problem;</text> </paragraph> <paragraph num="(2)"> <text>Drinking driver patterns and characteristics;</text> </paragraph> <paragraph num="(3)"> <text>The pharmacology of drugs and alcohol;</text> </paragraph> <paragraph num="(4)"> <text>The process of addiction to drugs and alcohol;</text> </paragraph> <paragraph num="(5)"> <text>The relationship of substance use to criminal, health, family, and other social problems; and</text> </paragraph> <paragraph num="(6)"> <text>Treatment resources; and</text> </paragraph> </paragraph> <paragraph num="G."> <text>Report to the court or probation agent, as specified by the court order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Early Intervention Level 0.5 Program."> <text>To be licensed under this subtitle, an early intervention level 0.5 program shall:</text> <paragraph num="A."> <text>Provide services to individuals:</text> <paragraph num="(1)"> <text>Who meet the ASAM Criteria for level .05;</text> </paragraph> <paragraph num="(2)"> <text>For whom a diagnosable substance-related disorder is not documented; and</text> </paragraph> <paragraph num="(3)"> <text>Who are, for a known reason, at risk for developing a substance-related disorder;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide a comprehensive assessment, unless the participant has received an assessment by a licensed or certified clinician or licensed program within the preceding 45 days, of the participant’s current status and relevant history in the following areas:</text> <paragraph num="(1)"> <text>ATOD use;</text> </paragraph> <paragraph num="(2)"> <text>Employment or financial support;</text> </paragraph> <paragraph num="(3)"> <text>Gambling behavior;</text> </paragraph> <paragraph num="(4)"> <text>ATOD and gambling treatment history;</text> </paragraph> <paragraph num="(5)"> <text>Mental health;</text> </paragraph> <paragraph num="(6)"> <text>Legal involvement;</text> </paragraph> <paragraph num="(7)"> <text>Family and social systems;</text> </paragraph> <paragraph num="(8)"> <text>Educational involvement; and</text> </paragraph> <paragraph num="(9)"> <text>Somatic health, including a review of medications;</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the assessment determines that referral to a treatment program or other service is necessary, make a referral to a treatment program or other service as indicated; and</text> </paragraph> <paragraph num="D."> <text>Provide alcohol and drug education services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Requirements for Programs Requiring Non-Accreditation-Based Licenses."> <paragraph num="A."> <text>The provisions of this regulation apply to a program with a community-based behavioral health license that does not require accreditation.</text> </paragraph> <paragraph num="B."> <text>Participant Rights.</text> <paragraph num="(1)"> <text>A program shall:</text> <paragraph num="(a)"> <text>Treat each participant with consideration, respect, and full recognition of the participant’s human dignity and individuality;</text> </paragraph> <paragraph num="(b)"> <text>Provide care and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;</text> </paragraph> <paragraph num="(c)"> <text>Prohibit physical or mental abuse by the program staff;</text> </paragraph> <paragraph num="(d)"> <text>Provide an atmosphere free from discrimination;</text> </paragraph> <paragraph num="(e)"> <text>Prohibit use of any physical restraints;</text> </paragraph> <paragraph num="(f)"> <text>Ensure privacy and confidentiality; and</text> </paragraph> <paragraph num="(g)"> <text>Permit the participant to refuse to participate in any research.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A program shall post in a conspicuous area and provide to each participant a statement of participants’ rights.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Grievance Procedures. A program shall:</text> <paragraph num="(1)"> <text>Provide the participant on admission with a description of the program’s grievance policy and procedures, which shall include the:</text> <paragraph num="(a)"> <text>Participant’s right to grieve program decisions, including but not limited to:</text> <paragraph num="(i)"> <text>Discharge; and</text> </paragraph> <paragraph num="(ii)"> <text>Change in status or services;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Steps of the grievance process; and</text> </paragraph> <paragraph num="(c)"> <text>Levels to which the grievance may be taken;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Take no retaliation against a participant who presents a grievance; and</text> </paragraph> <paragraph num="(3)"> <text>Inform each participant if revisions are made to the grievance policy and the nature and extent of the revisions.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nondiscrimination. A program may not discriminate in the provision of services on the basis of race, creed, color, age, gender, sexual orientation, gender identity, national origin, marital status, disabilities, and any other classification prohibited under State or federal law, including:</text> <paragraph num="(1)"> <text>Americans with Disabilities Act, 42 U.S.C §12101 et seq.; and</text> </paragraph> <paragraph num="(2)"> <text>Fair Housing Act, 42 U.S.C. §3604.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> </annotations> </chapter> <chapter num="06" heading="Application and Licensure Process"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter sets forth the processes governing application for accreditation-based and non-accreditation-based licenses to provide community-based behavioral health services, issuance and parameters of the license, and sanctioning of licensees.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="License Application Process for All Community-Based Behavioral Health Programs."> <paragraph num="A."> <text>An applicant for a license, whether accreditation or non-accreditation-based, to provide community-based behavioral health services shall:</text> <paragraph num="(1)"> <text>Use the application form required by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Include the following information with the application:</text> <paragraph num="(a)"> <text>Verification that the program complies with the program descriptions and criteria set out in this subtitle;</text> </paragraph> <paragraph num="(b)"> <text>Attestation of compliance with relevant federal, State, or local ordinances, laws, regulations, and orders governing the program;</text> </paragraph> <paragraph num="(c)"> <text>Disclosure of the following:</text> <paragraph num="(i)"> <text>Any revocation of a license, certificate, or approval issued within the previous 10 years from any in-State or out-of-State provider previously or currently associated with the applicant, including deficiency reports and compliance records;</text> </paragraph> <paragraph num="(ii)"> <text>Whether the applicant, or a program, corporation, or provider previously or currently associated with the applicant, has surrendered or defaulted on its license, certificate, or approval for reasons related to disciplinary action, within the previous 10 years;</text> </paragraph> <paragraph num="(iii)"> <text>The identity of any individual who has served as a corporate officer for the provider who has had a license, certificate or approval revoked, or has surrendered or defaulted on an approval license, certificate or approval, for reasons related to disciplinary action, within the previous 10 years; and</text> </paragraph> <paragraph num="(iv)"> <text>Any criminal conviction of the applicant, or the owner, program director, or other staff of the applicant;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Include the following documents with the application:</text> <paragraph num="(a)"> <text>A copy of the agreement to cooperate between the program and the CSA, LAA, or LBHA, as appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Copies of all applicable permits required by local jurisdictions, including fire, safety, and health, for each proposed site, if the program will provide services at a site whose primary function is the delivery of behavioral health services; and</text> </paragraph> <paragraph num="(c)"> <text>All documentation supporting or demonstrating the information disclosed under §A(2)(c) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Include any other information considered necessary and requested by the Department; and</text> </paragraph> <paragraph num="(5)"> <text>Submit the completed application to the Department’s designated approval unit, identifying:</text> <paragraph num="(a)"> <text>The services that the applicant would provide if licensed; and</text> </paragraph> <paragraph num="(b)"> <text>The physical sites where the services would be provided;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the application submitted under §A of this regulation is incomplete or missing any of the documentation required by this regulation, the application shall be returned to the program to provide the missing information, and processing of the application shall stop until the information is provided.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Application Requirements for Licenses Requiring Accreditation."> <paragraph num="A."> <text>In addition to the application requirements for all community-based behavioral health services licenses, the provisions of this regulation apply to all applicants for licenses to provide community-based behavioral health services, if the license is required by this subtitle to be accreditation-based.</text> </paragraph> <paragraph num="B."> <text>A program applying for an accreditation-based license to provide community-based behavioral health services shall submit with the program’s application:</text> <paragraph num="(1)"> <text>The program’s most recent behavioral health accreditation survey report;</text> </paragraph> <paragraph num="(2)"> <text>Any corrective action plans required by the behavioral health accreditation organization survey report of the program; and</text> </paragraph> <paragraph num="(3)"> <text>The final letter or certificate issuing accreditation for the program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before determining whether a program requiring an accreditation-based license to provide community-based behavioral health services is eligible for licensure, the Department’s designated approval unit may conduct an on-site review in cases in which significant concerns have been raised regarding the operations of the program or the organization that accredited the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Additional Application Requirements for Licenses Not Requiring Accreditation."> <paragraph num="A."> <text>In addition to the application requirements for all community-based behavioral health services licenses, the provisions of this regulation apply to all applicants for licenses to provide community-based behavioral health services, if the license is permitted by this subtitle to be non-accreditation-based.</text> </paragraph> <paragraph num="B."> <text>A program applying for a non-accreditation-based license to provide community-based behavioral health services shall pass an inspection by the Department, or its designee, of all of the program’s sites before issuance of the license;</text> </paragraph> <paragraph num="C."> <text>The on-site inspection conducted under §B of this regulation shall include:</text> <paragraph num="(1)"> <text>A tour of the physical plant for safety and quality and compliance with regulations and codes;</text> </paragraph> <paragraph num="(2)"> <text>Interviews with the staff to verify training and competencies; and</text> </paragraph> <paragraph num="(3)"> <text>A review of emergency and disaster preparedness systems.</text> </paragraph> </paragraph> <paragraph num="D."> <text>During the on-site inspection, the Department shall ascertain whether the physical plant:</text> <paragraph num="(1)"> <text>Provides sufficient space for required services;</text> </paragraph> <paragraph num="(2)"> <text>Is appropriately furnished, well lit, adequately ventilated, and easily accessible;</text> </paragraph> <paragraph num="(3)"> <text>Is maintained in good repair, safe, clean and free of insects and rodents and hazards;</text> </paragraph> <paragraph num="(4)"> <text>Provides secure storage for participant records;</text> </paragraph> <paragraph num="(5)"> <text>Provides for the safe and sanitary disposal of trash; and</text> </paragraph> <paragraph num="(6)"> <text>Provides marked fire exits and the posting of evacuation routes.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Issuance and Duration of Accreditation-Based and Non-Accreditation-Based Licenses."> <paragraph num="A."> <text>If the Department’s designated approval unit determines that a program is eligible for a license to provide community-based behavioral health services, whether accreditation-based or non-accreditation-based, the Department’s designated approval unit shall issue a license to the program that specifies the:</text> <paragraph num="(1)"> <text>Programs that the applicant is licensed to provide, including the addresses of all sites where the services will be provided;</text> </paragraph> <paragraph num="(2)"> <text>Duration of the licensure period:</text> </paragraph> <paragraph num="(3)"> <text>Name of the accreditation organization, if applicable; and</text> </paragraph> <paragraph num="(4)"> <text>Date of issue.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The duration of the license:</text> <paragraph num="(1)"> <text>For an accreditation-based license, shall equal the accreditation period plus 3 months; and</text> </paragraph> <paragraph num="(2)"> <text>For a non-accreditation-based license, may not exceed 3 years.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department’s designated approval unit shall notify the following when a license has been issued for a program:</text> <paragraph num="(1)"> <text>The Administration;</text> </paragraph> <paragraph num="(2)"> <text>The CSA, LAA, or LBHA, as appropriate, of the jurisdiction in which the program is providing or will provide services;</text> </paragraph> <paragraph num="(3)"> <text>The Medical Assistance Program; and</text> </paragraph> <paragraph num="(4)"> <text>The ASO for MDH.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The program director shall ensure that the license:</text> <paragraph num="(1)"> <text>For non-residential programs, is posted in clear view during the regular hours of operation; or</text> </paragraph> <paragraph num="(2)"> <text>For residential programs, is available for review during regular hours of operation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In order to be approved, an application for renewal of a license and supporting documentation shall be received by the Department or its designee at least 60 days before the expiration of the program’s current license.</text> </paragraph> <paragraph num="F."> <text>If the program fails to submit the application and supporting documentation within the timeframe established in §E of this regulation, the program’s license shall be suspended from the license expiration date until the issuance of a new license for the program.</text> </paragraph> <paragraph num="G."> <text>If the Department’s designated approval unit suspends the program’s license in accordance with §F of this regulation, the program director shall immediately take the actions described in Regulation .11D of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Denial of License to Provide Community-Based Behavioral Health Services."> <paragraph num="A."> <text>The Department may deny a license to provide community-based behavioral health services to:</text> <paragraph num="(1)"> <text>An applicant, if the Department’s designated approval unit determines that the application does not meet the licensure requirements;</text> </paragraph> <paragraph num="(2)"> <text>An applicant that has had a license or approval revoked by the Department or other licensing agency, or has surrendered or defaulted on its license or other approval for reasons related to disciplinary action, within the previous 10 years;</text> </paragraph> <paragraph num="(3)"> <text>An applicant that has an officer who has served as an officer for a provider that has had a license revoked, or has surrendered or defaulted on its license or other approval for reasons related to disciplinary action, within the previous 10 years; or</text> </paragraph> <paragraph num="(4)"> <text>Any program that discontinues operations without complying with Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Department’s designated approval unit denies licensure to an applicant under this chapter, the Department’s designated approval unit shall give written notice of the proposed denial to the program.</text> </paragraph> <paragraph num="C."> <text>The notice of the proposed denial of an application for a license shall include:</text> <paragraph num="(1)"> <text>The facts that warrant the proposed denial of licensure; and</text> </paragraph> <paragraph num="(2)"> <text>Notice that the program has a right to a hearing in accordance with Regulation .19 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="License Modification."> <paragraph num="A."> <text>A program may not change its program sites by adding, closing, or moving locations without prior approval from the Department’s designated approval unit.</text> </paragraph> <paragraph num="B."> <text>To request a change in its program sites by adding, closing, or moving locations, a licensed program shall submit to the Department’s designated approval unit:</text> <paragraph num="(1)"> <text>An application modification on the form required by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Evidence that the program has notified the appropriate accreditation organization of the proposed program modification, if the program has an accreditation-based license;</text> </paragraph> <paragraph num="(3)"> <text>Evidence that the program has notified the appropriate CSA, LAA, or LBHA of the proposed program modification;</text> </paragraph> <paragraph num="(4)"> <text>Evidence that the program has notified the program participants of any proposed change in program site; and</text> </paragraph> <paragraph num="(5)"> <text>Copies of all applicable permits required by local jurisdictions, including fire, safety, and health, for each proposed site, if the program will provide services at a site whose primary function is the delivery of behavioral health services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>To request a change in its service array, a licensed program shall submit to the Department’s designated approval unit:</text> <paragraph num="(1)"> <text>If applicable, evidence that the program has received accreditation for the proposed additional program type; and</text> </paragraph> <paragraph num="(2)"> <text>Evidence that the program has notified the appropriate CSA, LAA, or LBHA of the proposed program modification.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Before being approved for any modification described in this regulation, the following programs shall pass an inspection of the sites by the Department or its designee:</text> <paragraph num="(1)"> <text>Programs with a non-accreditation-based license; and</text> </paragraph> <paragraph num="(2)"> <text>Residential sites described in COMAR 10.63.04.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the Department’s designated approval unit approves the application modification submitted under §B or C of this regulation, the existing program license shall extend to the additional program and additional site, as applicable.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Waivers and Variances."> <paragraph num="A."> <text>Waivers. The Administration may not grant waivers of:</text> <paragraph num="(1)"> <text>The requirements of any regulation adopted under this subtitle; or</text> </paragraph> <paragraph num="(2)"> <text>Any accreditation standard.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Variances.</text> <paragraph num="(1)"> <text>If a program is licensed under this chapter, the Administration may grant a variance for a regulation if the Administration:</text> <paragraph num="(a)"> <text>Receives a written request from a program on the form required by the Administration; and</text> </paragraph> <paragraph num="(b)"> <text>Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any variance granted by the Administration shall:</text> <paragraph num="(a)"> <text>Remain in effect for as long as the program continues to comply with the conditions under which the variance is granted; or</text> </paragraph> <paragraph num="(b)"> <text>Be time-limited.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Administration may not grant a variance:</text> <paragraph num="(a)"> <text>That would endanger the health or safety of the individuals served; or</text> </paragraph> <paragraph num="(b)"> <text>For any accreditation standard.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Administration shall:</text> <paragraph num="(a)"> <text>Issue a written decision on the request for a variance, including the reason or reasons for granting or not granting the variance;</text> </paragraph> <paragraph num="(b)"> <text>Send the decision to the:</text> <paragraph num="(i)"> <text>Program director;</text> </paragraph> <paragraph num="(ii)"> <text>CSA, LAA, or LBHA, as appropriate; and</text> </paragraph> <paragraph num="(iii)"> <text>Department’s designated approval unit; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Enter the decision in the records of the Administration.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Sale or Transfer of License to Provide Community-Based Behavioral Health Services."> <paragraph num="A."> <text>The license of a program to provide community-based behavioral health services shall be valid only for the program and address for which the license is issued.</text> </paragraph> <paragraph num="B."> <text>If the sale or transfer of a program causes a change in ownership, the program:</text> <paragraph num="(1)"> <text>May not sell, assign, or transfer its license; and</text> </paragraph> <paragraph num="(2)"> <text>Shall apply for and receive a new license to operate in Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Discontinuation of Program Operations."> <paragraph num="A."> <text>If a program licensed to provide community-based behavioral health services intends to discontinue operations, the program director shall, no less than 60 calendar days before the program intends to discontinue operations, submit to the Department’s licensure unit, the Administration, and the CSA, LAA, or LBHA, as appropriate, its written plan for:</text> <paragraph num="(1)"> <text>Cessation of operations, including relevant dates;</text> </paragraph> <paragraph num="(2)"> <text>Informing participants in the program or their guardians of the planned discontinuation and of other behavioral health service options;</text> </paragraph> <paragraph num="(3)"> <text>Transitioning participants in the program to other behavioral health services;</text> </paragraph> <paragraph num="(4)"> <text>Storing and protecting all records; and</text> </paragraph> <paragraph num="(5)"> <text>Notifying employees, contractors, consultants, and consumers of its cessation of operations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Within 30 days after receipt of the program’s request to discontinue operations, the Department’s designated approval unit shall:</text> <paragraph num="(1)"> <text>Notify the program in writing whether its plan is acceptable; and</text> </paragraph> <paragraph num="(2)"> <text>If the plan is unacceptable, meet with the program and the CSA, LAA, or LBHA as appropriate, to make a plan that protects the health, safety, and welfare of the individuals served by the program and program staff.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The program may not discontinue operations until the Department’s designated approval unit authorizes the discontinuation.</text> </paragraph> <paragraph num="D."> <text>Once the Department has approved the discontinuation plan, the program shall implement the plan.</text> </paragraph> <paragraph num="E."> <text>At all times during the discontinuation process, the program shall cooperate with the Administration, the Department’s designated approval unit, and the CSA, LAA, or LBHA, as appropriate.</text> </paragraph> <paragraph num="F."> <text>If a program that is discontinuing operation does not comply with §§A—E of this regulation, the Department may deny any future application for a license that the program, or principals of the program, may submit.</text> </paragraph> <paragraph num="G."> <text>If a program licensed to provide community-based behavioral health services intends to discontinue a service, the program director shall provide immediate notification to the:</text> <paragraph num="(1)"> <text>CSA;</text> </paragraph> <paragraph num="(2)"> <text>LAA;</text> </paragraph> <paragraph num="(3)"> <text>LBHA; or</text> </paragraph> <paragraph num="(4)"> <text>OHCQ.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Summary Suspension."> <paragraph num="A."> <text>Upon finding that a program licensed under this chapter has violated a regulation and that the public health, safety, or welfare imperatively requires emergency action, the Department may order the immediate suspension of the license of the program and the immediate cessation of the program’s operation.</text> </paragraph> <paragraph num="B."> <text>Following the summary suspension of the license of the program, and under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Department shall deliver a written notice to the program that includes:</text> <paragraph num="(1)"> <text>The facts supporting the finding that the public health, safety, or welfare imperatively require the emergency action; and</text> </paragraph> <paragraph num="(2)"> <text>Notice that the program may request a hearing under Regulation .19 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the program requests a hearing on the summary suspension, the Department shall provide an administrative hearing after the suspension, in accordance with Regulation .20 of this chapter.</text> </paragraph> <paragraph num="D."> <text>If the Department summarily suspends the license of a program, the program shall immediately:</text> <paragraph num="(1)"> <text>Stop providing services to individuals; and</text> </paragraph> <paragraph num="(2)"> <text>Develop and implement a written plan, approved by the Department, to:</text> <paragraph num="(a)"> <text>Notify individuals receiving services from the program, or the guardians of these individuals, of the suspension;</text> </paragraph> <paragraph num="(b)"> <text>Transition individuals receiving services from the program to an alternative program or make other arrangements to ensure continuity of services for the individuals;</text> </paragraph> <paragraph num="(c)"> <text>Store and protect all service and medical records, and transition the records to alternative program or to the individual; and</text> </paragraph> <paragraph num="(d)"> <text>Notify employees, contractors, consultants, and consumers of its cessation of operations.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Notice of Deficiencies."> <paragraph num="A."> <text>If the Department determines that a program licensed under this chapter has violated any provision of this chapter, but does not summarily suspend the program, the Department’s designated approval unit shall provide the program with a notice of deficiencies.</text> </paragraph> <paragraph num="B."> <text>In the notice of deficiencies, the Department’s designated approval unit shall list each failure to comply with a requirement, including identifying the requirement and the basis for the finding.</text> </paragraph> <paragraph num="C."> <text>Plan of Correction.</text> <paragraph num="(1)"> <text>The program shall submit a plan of correction to the Department’s designated approval unit within 10 working days of receipt of the notice of deficiencies, stating how and when each failure to comply shall be corrected.</text> </paragraph> <paragraph num="(2)"> <text>The Department’s designated approval unit may require that the POC be submitted sooner than 10 working days when the nature of the noncompliance warrants a more immediate response, as determined by the Department’s designated approval unit.</text> </paragraph> <paragraph num="(3)"> <text>The director of the Department’s designated approval unit may grant an extension of not more than 30 days for the submission of the POC.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If the Department issues a notice of deficiencies to a program under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, that the program has received a notice of deficiencies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="License Revocation."> <paragraph num="A."> <text>If the Department’s designated approval unit determines that a program licensed under this chapter has violated a requirement of this chapter, the Department may revoke the license.</text> </paragraph> <paragraph num="B."> <text>If the Department’s designated approval unit determines that the program has violated a requirement of a sanction imposed under Regulation .14 of this chapter, the Department may revoke the license.</text> </paragraph> <paragraph num="C."> <text>If the Department revokes a program’s license under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, of the revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Intermediate Sanctions."> <paragraph num="A."> <text>If the Department determines that a program licensed under this chapter has violated a requirement of this subtitle, the Department’s designated approval unit may take one or more of the following actions:</text> <paragraph num="(1)"> <text>Prohibit the program from serving any additional individuals;</text> </paragraph> <paragraph num="(2)"> <text>Require the program to reduce the number of individuals currently receiving services;</text> </paragraph> <paragraph num="(3)"> <text>Prohibit the program from providing specific services or restricting the program to providing only specified services;</text> </paragraph> <paragraph num="(4)"> <text>Require the program, and any of its staff, to receive mandatory training in identified areas;</text> </paragraph> <paragraph num="(5)"> <text>Require the program to use the services of a consultant approved in advance by the Department;</text> </paragraph> <paragraph num="(6)"> <text>Require the establishment of an escrow account;</text> </paragraph> <paragraph num="(7)"> <text>Impose a civil money penalty, in accordance with this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the Department imposes a sanction under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, of the sanction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Directed Plan of Correction."> <paragraph num="A."> <text>If the Department determines that a program licensed under this chapter has violated any requirement of this chapter, the Department’s designated approval unit may impose a directed plan of correction, in addition to any intermediate sanctions imposed in accordance with this chapter.</text> </paragraph> <paragraph num="B."> <text>The directed plan of correction may include any one or more of the following:</text> <paragraph num="(1)"> <text>Mandating staffing patterns, specifying the number of personnel, personnel qualifications, or both;</text> </paragraph> <paragraph num="(2)"> <text>Imposing a temporary site monitor, whereby the Department maintains an on-going physical presence for the purpose of providing assistance and evaluating the extent of the program’s progress in correcting violations;</text> </paragraph> <paragraph num="(3)"> <text>Requiring the program to submit periodic reports of the program’s progress in correcting violations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the Department issues a directed plan of correction to a program under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, that the program has received a directed plan of correction.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Settlement Agreement."> <paragraph num="A."> <text>The Department may enter into a settlement agreement with a program licensed under this chapter that has violated a requirement of this chapter, establishing specific conditions for continued operation, including time limits for compliance.</text> </paragraph> <paragraph num="B."> <text>A settlement agreement is a public document and may be disseminated under the State Government Article, §§10-611—10-630, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A copy of the settlement agreement shall be distributed to individuals served by the program or posted in a public location at the program’s physical site.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Initiation of Receivership."> <text>The Secretary or designee may take action to initiate receivership of a program licensed under this chapter, pursuant to Health-General Article, §§19-333—19-339, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Civil Money Penalties."> <paragraph num="A."> <text>Notwithstanding any penalty that may be imposed under the Civil False Claims Act, pursuant to Health-General Article, §2-611, Annotated Code of Maryland or other statute, the Department may impose a civil monetary penalty on a person for:</text> <paragraph num="(1)"> <text>Operating a community-based behavioral health services program without a license, if one is required by law or regulation;</text> </paragraph> <paragraph num="(2)"> <text>Any material and egregious violation of any provision of this subtitle; or</text> </paragraph> <paragraph num="(3)"> <text>Both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In determining whether a civil monetary penalty is to be imposed, the Department shall consider the following, among any other relevant factors:</text> <paragraph num="(1)"> <text>The nature, number, and seriousness of the deficiencies;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of an ongoing pattern;</text> </paragraph> <paragraph num="(3)"> <text>The degree of risk to the health, life, or safety of the individuals receiving services from the program;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by the program, and the ability of the program, to correct the deficiency or deficiencies; and</text> </paragraph> <paragraph num="(5)"> <text>The program’s prior history of compliance or non-compliance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In determining the amount of any civil money penalty to be imposed, the Department shall consider the factors listed in §B of this regulation, among any other relevant factors.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Program’s Right to a Hearing on Proposed Sanctions."> <paragraph num="A."> <text>A program licensed under this chapter that is aggrieved by the proposal of the Department’s designated approval unit to take any of the following actions may appeal the Department’s decision by filing a request for an administrative hearing in accordance with Regulation .20 of this chapter:</text> <paragraph num="(1)"> <text>The denial of an application for a license or for renewal of a license;</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a license, under Regulation .11 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>The denial of a request for modification of a license, under Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>The denial of a request to discontinue a program, under Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>A revocation of a license, under Regulation .13 of this chapter;</text> </paragraph> <paragraph num="(6)"> <text>The imposition of a sanction under Regulation .14, .16, or .18 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the program submits a request for a hearing on a proposed summary suspension, the hearing shall take place in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Hearing Procedures."> <paragraph num="A."> <text>If the Department’s designated approval unit proposes to take an action listed in Regulation .19 of this chapter, the Department shall deliver a written notice of the proposed action to the program director, in accordance with the provisions of COMAR 10.01.03.05.</text> </paragraph> <paragraph num="B."> <text>Within 10 working days after receipt of the notice of the proposed action, the program may submit to the Department, at the address identified in the notice, a written request for a hearing, with copies to the:</text> <paragraph num="(1)"> <text>Administration;</text> </paragraph> <paragraph num="(2)"> <text>CSA, LAA, or LBHA, as appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>Director of the Department’s designated approval unit.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the program does not submit to the Department a hearing request that is postmarked within 10 working days after the date on the notice:</text> <paragraph num="(1)"> <text>The program’s right to a hearing is waived; and</text> </paragraph> <paragraph num="(2)"> <text>The Department’s designated approval unit may implement the proposed action.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may offer the program the opportunity, when possible, for an informal case resolution conference, in which to attempt to resolve all or some of the deficiencies listed in the notice.</text> </paragraph> <paragraph num="E."> <text>The hearing shall comply with the provisions of COMAR 10.01.03.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Deadlines and Effective Dates of this Chapter."> <paragraph num="A."> <text>Accreditation-based Licenses. The following shall apply for programs that are required by law and this chapter to be accredited to be licensed:</text> <paragraph num="(1)"> <text>A program may not operate on or after April 1, 2018 without a license;</text> </paragraph> <paragraph num="(2)"> <text>To be licensed on or before April 1, 2018, a program shall submit a completed and accurate application to the Department’s designated approval unit before January 1, 2018;</text> </paragraph> <paragraph num="(3)"> <text>An accreditation-based license may be issued on or after, and not before, January 1, 2017;</text> </paragraph> <paragraph num="(4)"> <text>The Department’s designated approval unit shall begin accepting applications for accreditation-based licenses on October 1, 2016;</text> </paragraph> <paragraph num="(5)"> <text>As of October 1, 2016, applications for an accreditation-based license shall include evidence that the program is accredited by an approved accreditation organization;</text> </paragraph> <paragraph num="(6)"> <text>The Department’s designated approval unit may not accept an application for initial certification or approval under COMAR Title 10, Subtitles 21 or 47 after September 30, 2016;</text> </paragraph> <paragraph num="(7)"> <text>A program with a certification or approval under COMAR Title 10, Subtitles 21 or 47:</text> <paragraph num="(a)"> <text>May apply for renewal of the certification or approval before January 1, 2018;</text> </paragraph> <paragraph num="(b)"> <text>If eligible for renewal, shall receive a certification or approval, valid until April 1, 2018; and</text> </paragraph> <paragraph num="(c)"> <text>May not operate under the certification or approval after March 31, 2018.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A program that is certified or approved based on deemed status in accordance with COMAR 10.21.16.10 or COMAR 10.47.04.05 shall receive a license, which shall be effective during the current accreditation period; and</text> </paragraph> <paragraph num="(9)"> <text>If the Department’s designated approval unit cannot issue a license by April 1, 2018 for a program that submits a completed, accurate application for a license before January 1, 2018, the Department’s designated approval unit shall extend the expiration date of the existing approval or certification to complete the license application process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Non-Accreditation-Based Licenses. The following shall apply for programs that are not required by law and this chapter to be accredited to be licensed:</text> <paragraph num="(1)"> <text>A program may not operate on or after April 1, 2018 without a license;</text> </paragraph> <paragraph num="(2)"> <text>A program that is certified or approved under COMAR Title 10, Subtitles 21 or 47, may operate under those subtitles until the expiration of the term of its current certification or approval, but not after March 31, 2018;</text> </paragraph> <paragraph num="(3)"> <text>The Department’s designated approval unit may not accept an application for initial certification or approval under COMAR Title 10, Subtitles 21 or 47, after September 30, 2016;</text> </paragraph> <paragraph num="(4)"> <text>A program with a current certification or approval under COMAR Title 10, Subtitles 21 or 47:</text> <paragraph num="(a)"> <text>May apply for renewal of the certification or approval under COMAR Title 10, Subtitles 21 or 47, before January 1, 2018; and</text> </paragraph> <paragraph num="(b)"> <text>May not operate after March 31, 2018 without a license.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>To be licensed on or before April 1, 2018, a program shall submit a completed and accurate application to the Department’s designated approval unit before January 1, 2018;</text> </paragraph> <paragraph num="(6)"> <text>A license may be issued on or after, and not before, January 1, 2017; and</text> </paragraph> <paragraph num="(7)"> <text>If the Department’s designated approval unit cannot issue a license by April 1, 2018 for a program that submits a completed accurate application for licensure before January 1, 2018, the Department’s designated approval unit shall extend that expiration date of the existing approval or certification to complete the license application process.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Applicability Dates of Regulations. Current chapters of regulations under COMAR 10.21 and 10.47 shall remain in effect concurrently with the regulations in this chapter until April 1, 2018.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2016 (43:10 Md. R. 585)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10G adopted effective February 27, 2017 (44:4 Md. R. 255)</annotation> </annotations> </chapter> <chapter num="07" heading="Outpatient Civil Commitment (OCC) Pilot Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter establishes a pilot program for outpatient civil commitment (OCC) to allow for the release of individuals who are involuntarily committed for inpatient treatment under Health-General Article, §10-632, Annotated Code of Maryland, on the condition of admission to the OCC pilot program.</text> </paragraph> <paragraph num="B."> <text>This chapter is not intended to impose any exhaustion requirement on an individual as a prerequisite to the individual’s pursuing concurrently or in any order any legal remedy to obtain release from an inpatient facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administration” means the Behavioral Health Administration and its agents or designees.</text> </paragraph> <paragraph num="(2)"> <text>“Administrative law judge (ALJ)” means an individual in the Office of Administrative Hearings authorized under State Government Article, §9-1604, Annotated Code of Maryland, to conduct hearings under this chapter.</text> </paragraph> <paragraph num="(3)"> <text>“Application” means the application made by the inpatient facility to the Administration, which seeks the voluntary or involuntary outpatient admission of an individual to the outpatient civil commitment pilot program.</text> </paragraph> <paragraph num="(4)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(5)"> <text>“Discharge” means the removal or withdrawal of an individual from the outpatient civil commitment pilot program and the termination of the outpatient civil commitment order.</text> </paragraph> <paragraph num="(6)"> <text>“Eligible resident” means an individual who:</text> <paragraph num="(a)"> <text>Has a current residence in Baltimore City or a contiguous zip code; or</text> </paragraph> <paragraph num="(b)"> <text>Is willing to establish a residence in Baltimore City or a contiguous zip code.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Federal grant program funding” means the funding awarded pursuant to the Substance Abuse Mental Health Services Administrations Assisted Outpatient Treatment Grant Program for Individuals with Serious Mental Illness, established by the Protecting Access to Medicare Act of 2014, section 224.</text> </paragraph> <paragraph num="(8)"> <text>Inpatient Facility.</text> <paragraph num="(a)"> <text>“Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders.</text> </paragraph> <paragraph num="(b)"> <text>“Inpatient facility” includes a Veterans' Administration (VA) hospital.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Involuntary inpatient facility admissions” means that an individual has been admitted to an inpatient facility by an ALJ following an involuntary admission hearing pursuant to Health-General Article, §10-632, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Involuntary outpatient admission” means the admission of an individual into the outpatient civil commitment pilot program who shall be subject to conditions imposed by the Administration and ordered by an ALJ following a hearing as described in this chapter.</text> </paragraph> <paragraph num="(11)"> <text>“Legal service provider” means the entity that the Department designates to provide representation for an individual at the proceedings described in this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Licensed certified social worker-clinical” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Licensed clinical professional counselor” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 17, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(14)"> <text>“Licensed master social worker” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 19, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(15)"> <text>Mental Disorder.</text> <paragraph num="(a)"> <text>“Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder.</text> </paragraph> <paragraph num="(b)"> <text>“Mental disorder” includes a mental illness that substantially impairs the mental or emotional functioning of an individual as to make care or treatment necessary or advisable for the welfare of the individual or for the safety of the individual or property of another.</text> </paragraph> <paragraph num="(c)"> <text>“Mental disorder” does not include mental retardation or a primary diagnosis of alcohol or drug abuse.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Office of Administrative Hearings” means the office created under State Government Article, §9-1602, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(17)"> <text>“Order” means the formal written order issued by an Administrative Law Judge committing an individual into the outpatient civil commitment pilot program.</text> </paragraph> <paragraph num="(18)"> <text>“Outpatient civil commitment (OCC) pilot program” means the program established by the Behavioral Health Administration to provide community-based treatment and supports to:</text> <paragraph num="(a)"> <text>Individuals involuntarily ordered by an ALJ to participate in the OCC pilot program as a condition of release from inpatient admission; or</text> </paragraph> <paragraph num="(b)"> <text>Individuals who choose to participate in the OCC pilot program voluntarily after a settlement conference with the legal service provider and a representative of the inpatient facility.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Physician” means an individual licensed under Health Occupations Article, Title 14, Annotated Code of Maryland, to practice medicine in this State.</text> </paragraph> <paragraph num="(20)"> <text>“Program” means the outpatient civil commitment (OCC) pilot program.</text> </paragraph> <paragraph num="(21)"> <text>“Psychiatric nurse practitioner” means an individual licensed to practice registered nursing in this State and certified to practice as an advanced practice registered nurse/psychiatric mental health (APRN/PMH) under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(22)"> <text>“Psychiatrist” means a physician who:</text> <paragraph num="(a)"> <text>Is licensed by the Maryland Board of Physicians; and</text> </paragraph> <paragraph num="(b)"> <text>Is either:</text> <paragraph num="(i)"> <text>Certified in psychiatry by the American Board of Psychiatry and Neurology; or</text> </paragraph> <paragraph num="(ii)"> <text>Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Psychologist” means an individual who is:</text> <paragraph num="(a)"> <text>Licensed under Health Occupations Article, Title 18, Annotated Code of Maryland, to practice psychology; and</text> </paragraph> <paragraph num="(b)"> <text>Listed in the National Register of Health Service Providers in Psychology.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>“Release” means the authorization for an individual who is confined in an inpatient facility under Health-General Article, §10-632, Annotated Code of Maryland, to leave the inpatient facility on the condition of admission to the OCC pilot program.</text> </paragraph> <paragraph num="(25)"> <text>“Voluntary inpatient admission” means the admission of an individual to an inpatient facility on the basis of:</text> <paragraph num="(a)"> <text>A signed and endorsed formal application for voluntary admission pursuant to Health-General Article, §10-609 or 10-610, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>An informal request for admission pursuant to Health-General Article, §10-609, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>If the voluntary admission is to a VA hospital, the procedure established by the VA hospital.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“Voluntary outpatient admission” means the admission of an individual to the outpatient civil commitment pilot program described in this chapter voluntarily after a settlement conference with the legal service provider and a representative of the inpatient facility.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Pilot Program."> <paragraph num="A."> <text>The Department authorizes the Administration to create a program to provide community-based treatment to individuals with mental disorders who were:</text> <paragraph num="(1)"> <text>Admitted to an inpatient facility under Health-General Article, Title 10, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Released on condition of admission to the program pursuant to the requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program shall be funded with money received from a federal government grant to conduct an outpatient civil commitment program.</text> </paragraph> <paragraph num="C."> <text>The program shall be limited to eligible residents.</text> </paragraph> <paragraph num="D."> <text>Individuals shall be admitted to the program through voluntary outpatient admission or involuntary outpatient admission consistent with this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Length of Time of the Pilot Program."> <text>The program and the regulations under this chapter shall end on the expiration of the federal grant program funding.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Admission Criteria."> <paragraph num="A."> <text>To be involuntarily admitted to the program, an individual shall meet the following criteria:</text> <paragraph num="(1)"> <text>Have a mental disorder;</text> </paragraph> <paragraph num="(2)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(3)"> <text>Be an eligible resident;</text> </paragraph> <paragraph num="(4)"> <text>Have had two or more involuntary inpatient facility admissions in the preceding 12 months, including the most recent admission, before the application for admission into the program;</text> </paragraph> <paragraph num="(5)"> <text>Has a demonstrated history of refusing community treatment that has been a significant factor in contributing to the current involuntary inpatient admission;</text> </paragraph> <paragraph num="(6)"> <text>Has a treatment history and behavior that indicates the need for outpatient treatment to prevent deterioration after discharge and that is substantially likely to result in the individual becoming a danger to self or others in the community in the foreseeable future;</text> </paragraph> <paragraph num="(7)"> <text>Has been offered, and refused, the opportunity to accept voluntary outpatient admission into the program on discharge from the inpatient facility;</text> </paragraph> <paragraph num="(8)"> <text>Is substantially likely to benefit from the outpatient treatment;</text> </paragraph> <paragraph num="(9)"> <text>Would not be a danger to self or others in the community if released to the program; and</text> </paragraph> <paragraph num="(10)"> <text>For whom treatment in the program is the least restrictive alternative appropriate for the individual.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Involuntary Admission.</text> <paragraph num="(1)"> <text>To be voluntarily admitted to the program, an individual shall meet the following criteria:</text> <paragraph num="(a)"> <text>Have a mental disorder;</text> </paragraph> <paragraph num="(b)"> <text>Be 18 years old or older;</text> </paragraph> <paragraph num="(c)"> <text>Be an eligible resident who has had:</text> <paragraph num="(i)"> <text>A combination of two voluntary or involuntary inpatient facility admissions in the preceding 12 months, including the most recent admission before the application for admission into the program; or</text> </paragraph> <paragraph num="(ii)"> <text>One inpatient facility admission and three psychiatric emergency department visits in the preceding 12 months;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Have a demonstrated history of refusing community treatment that has been a significant factor in contributing to the current inpatient admission;</text> </paragraph> <paragraph num="(e)"> <text>Have a treatment history and behavior that indicates the need for outpatient treatment to prevent deterioration after discharge that is substantially likely to result in the individual becoming a danger to self or others in the community in the foreseeable future;</text> </paragraph> <paragraph num="(f)"> <text>Show that they are substantially likely to benefit from the outpatient treatment;</text> </paragraph> <paragraph num="(g)"> <text>Not be a danger to self or others in the community if released to the program;</text> </paragraph> <paragraph num="(h)"> <text>Be able to demonstrate that treatment in the program is the least restrictive alternative appropriate for the individual;</text> </paragraph> <paragraph num="(i)"> <text>Participate in a settlement conference with the legal service provider and a representative of the inpatient facility; and</text> </paragraph> <paragraph num="(j)"> <text>Enter into a settlement agreement whereby the individual agrees to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the individual is eligible, an immediate family member may request voluntary enrollment.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Admission."> <paragraph num="A."> <text>The administrative head of an inpatient facility may submit an application to the Administration for admission to the program of an individual who is committed to the inpatient facility under Health-General Article, §10-632, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Administration shall provide an application form that includes the following:</text> <paragraph num="(1)"> <text>The statutory authority for the application;</text> </paragraph> <paragraph num="(2)"> <text>The applicant’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Address; and</text> </paragraph> <paragraph num="(c)"> <text>Telephone number;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The name and address of the individual for whom the program is being requested;</text> </paragraph> <paragraph num="(4)"> <text>The criteria for admission into the program;</text> </paragraph> <paragraph num="(5)"> <text>The facts that support the applicant’s determination that the individual who is the subject of the application meets each criterion for admission to the program; and</text> </paragraph> <paragraph num="(6)"> <text>The signature and verification by a physician, psychiatrist, psychologist, psychiatric nurse practitioner, licensed certified social worker-clinical, licensed master social worker, or licensed clinical professional counselor on behalf of the inpatient facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the individual’s address is unknown, or the individual is homeless, the address of the inpatient facility may be used.</text> </paragraph> <paragraph num="D."> <text>If an application does not include the information required under §B of this regulation, the Administration may not consider the application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Application Approval and Development of Treatment Plan."> <paragraph num="A."> <text>Within 3 business days from receiving an application for admission, the Administration shall:</text> <paragraph num="(1)"> <text>Determine whether the individual meets the criteria for admission to the program;</text> </paragraph> <paragraph num="(2)"> <text>Determine whether the program is appropriate to meet the individual’s needs; and</text> </paragraph> <paragraph num="(3)"> <text>Provide written notice to the individual and to the administrative head of the inpatient facility of the Administration’s decision to approve or deny the application.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the application is approved, the Administration shall oversee the development of the proposed program treatment plan.</text> </paragraph> <paragraph num="C."> <text>If the application is denied, the individual may not be admitted into the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Schedule of Hearing, Notice of Hearing, and Rights."> <paragraph num="A."> <text>If the application for admission to the program has been approved, the inpatient facility staff shall:</text> <paragraph num="(1)"> <text>Schedule a hearing with the Office of Administrative Hearings;</text> </paragraph> <paragraph num="(2)"> <text>Notify the legal service provider that the hearing has been scheduled;</text> </paragraph> <paragraph num="(3)"> <text>Provide the individual with a copy of the application and proposed treatment plan; and</text> </paragraph> <paragraph num="(4)"> <text>Provide the individual with a copy of the Notice of Hearing and Rights.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The parent, guardian, or next of kin of an individual approved for admission to the program:</text> <paragraph num="(1)"> <text>Shall be given notice of the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>May offer evidence and testify at the hearing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The notice of hearing and rights shall be on the form provided by the Administration and shall include:</text> <paragraph num="(1)"> <text>The date, time, and place that the hearing will be held;</text> </paragraph> <paragraph num="(2)"> <text>The legal authority for and purpose of the hearing;</text> </paragraph> <paragraph num="(3)"> <text>A short statement explaining why the individual’s admission to the program is being sought;</text> </paragraph> <paragraph num="(4)"> <text>The criteria set forth in Regulation .06 of this chapter that govern whether the individual shall be admitted to the program;</text> </paragraph> <paragraph num="(5)"> <text>The individual’s right to consult with an attorney of the individual’s choice and, if the individual is unable to afford an attorney, the availability of representation at the hearing through the legal service provider; and</text> </paragraph> <paragraph num="(6)"> <text>The individual’s rights at the hearing as set forth in Regulation .09 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Hearing."> <paragraph num="A."> <text>Within 10 business days from the Administration’s approval of the program application, a hearing shall be held by the Office of Administrative Hearings to decide if the patient meets the program admission requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>The hearing may be postponed for good cause for not more than 10 business days from date of the postponed hearing.</text> </paragraph> <paragraph num="C."> <text>Burden of Proof. The Administration shall demonstrate by clear and convincing evidence that the individual meets each of the requirements set forth under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Rights of Parties.</text> <paragraph num="(1)"> <text>At a hearing, the parties have the right to:</text> <paragraph num="(a)"> <text>Be represented by counsel;</text> </paragraph> <paragraph num="(b)"> <text>Present witnesses;</text> </paragraph> <paragraph num="(c)"> <text>Cross-examine witnesses presented by the other party;</text> </paragraph> <paragraph num="(d)"> <text>Present documentary or other relevant evidence;</text> </paragraph> <paragraph num="(e)"> <text>Submit rebuttal evidence; and</text> </paragraph> <paragraph num="(f)"> <text>Present summation and argument.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In addition, an individual has the right to:</text> <paragraph num="(a)"> <text>Wear the individual’s choice of clothes; and</text> </paragraph> <paragraph num="(b)"> <text>Be present or waive the right to be present, if the waiver is:</text> <paragraph num="(i)"> <text>Knowingly and intelligently made; and</text> </paragraph> <paragraph num="(ii)"> <text>Witnessed by the individual’s counsel.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Findings and Conclusions. After the evidence and testimony are presented, and following summation and argument by the parties, the ALJ shall:</text> <paragraph num="(1)"> <text>Consider all evidence and testimony of record;</text> </paragraph> <paragraph num="(2)"> <text>Rule on issues raised by the individual that relate to the admission of the individual into the program;</text> </paragraph> <paragraph num="(3)"> <text>Order the individual released into the program if the inpatient facility has met its burden of proof establishing that the individual meets the program admission criteria under Regulation .05 of this chapter; and</text> </paragraph> <paragraph num="(4)"> <text>State on the record the:</text> <paragraph num="(a)"> <text>Findings, including whether the individual waived the right to attend the hearing;</text> </paragraph> <paragraph num="(b)"> <text>Conclusions of law on any issue presented; and</text> </paragraph> <paragraph num="(c)"> <text>Right of the individual to judicial review of the decision of the ALJ under State Government Article, §10-222, Annotated Code of Maryland, and the procedure for requesting judicial review.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Orders."> <paragraph num="A."> <text>An order shall:</text> <paragraph num="(1)"> <text>Specify that each of the admission criteria has been met;</text> </paragraph> <paragraph num="(2)"> <text>Order the individual to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual; and</text> </paragraph> <paragraph num="(3)"> <text>Specify the date on which the order shall expire.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An order issued under this chapter shall expire at the end of the 180-day period beginning with the individual’s initial inpatient commitment under Health-General Article, §10-632, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Settlement Conference."> <paragraph num="A."> <text>If the individual elects to participate in the program voluntarily, the individual shall participate in a settlement conference.</text> </paragraph> <paragraph num="B."> <text>The settlement conference shall include the individual, the legal service provider, and a representative of the inpatient facility.</text> </paragraph> <paragraph num="C."> <text>In order for the individual to be voluntarily admitted to the program, the individual shall sign the settlement agreement and agree to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Discharge from the Program."> <paragraph num="A."> <text>Before Discharge. Before the expiration of the program order, the Administration shall ensure that a transition plan is in place which provides the outpatient services necessary to support the individual in the community.</text> </paragraph> <paragraph num="B."> <text>Early Discharge. The Administration may discharge an individual from the program prior to the expiration of the program order upon finding that the individual is:</text> <paragraph num="(1)"> <text>Not likely a danger to self or others without the order; and</text> </paragraph> <paragraph num="(2)"> <text>Compliant with the treatment plan and is likely to remain compliant in the future without the order.</text> </paragraph> </paragraph> <paragraph num="C."> <text>After Discharge. Following the discharge of a patient from the program, the Administration shall monitor the transition of the individual from the program to voluntary community services for 60 days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Relation to Other Admission Provisions."> <paragraph num="A."> <text>Nothing in this chapter prevents the admission to a hospital pursuant Health-General Article, §10-601 et seq., Annotated Code of Maryland, of an individual participating in the Program.</text> </paragraph> <paragraph num="B."> <text>An individual’s participation in the program does not prohibit the individual’s evaluation and involuntary admission under Health-General Article, §10-601 et seq., Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Effective Date."> <text>This chapter is effective July 1, 2017.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-205 and §7.5-205.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 6, 2017 (44:22 Md. R. 1037)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 9, 2019 (46:18 Md. R. 774); February 3, 2025 (52:2 Md. R. 67)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective September 9, 2019 (46:18 Md. R. 774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective February 3, 2025 (52:2 Md. R. 67)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 3, 2025 (52:2 Md. R. 67)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective September 9, 2019 (46:18 Md. R. 774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective September 9, 2019 (46:18 Md. R. 774)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 3, 2025 (52:2 Md. R. 67)</annotation> </annotations> </chapter> <chapter num="08" heading="Civil Money Penalty"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for the imposition of civil money penalties against an organization or program determined to be in violation of this subtitle.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Material and Egregious Violation</text> <paragraph num="(1)"> <text>“Material violation” means any course of conduct, including a single incident, that may cause a program, individual, or organization to fail to comply with any statutory, regulatory, or contractual requirement.</text> </paragraph> <paragraph num="(2)"> <text>“Material and egregious violation” includes but is not limited to:</text> <paragraph num="(a)"> <text>Fraudulent or other behavior which influences or may influence the payment or receipt of money or other property;</text> </paragraph> <paragraph num="(b)"> <text>Practices which affect or may affect the health or safety of any individual; or</text> </paragraph> <paragraph num="(c)"> <text>Practices which violate or may violate participant rights.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Civil Money Penalty — Imposition."> <paragraph num="A."> <text>The Department may impose a civil money penalty against an organization for a material violation of a State or federal law or regulation in any of its programs.</text> </paragraph> <paragraph num="B."> <text>The Department may additionally cite violations of accreditation standards in support of an identified violation of law or regulation.</text> </paragraph> <paragraph num="C."> <text>A civil money penalty may be imposed regardless of whether any other civil, criminal, or administrative action is taken against the organization or program by any State, federal, or Departmental agency for the same covered period or violation.</text> </paragraph> <paragraph num="D."> <text>If a violation occurs at multiple site locations of an organization, each location will constitute a separate violation. If there are multiple services at a location and the violation occurs with multiple services, each service will constitute a separate violation.</text> </paragraph> <paragraph num="E."> <text>If the Department determines that a material deficiency, or continuing pattern of deficiencies which together amount to a material and egregious violation, exists, the Department shall notify the organization of the deficiency or deficiencies and may:</text> <paragraph num="(1)"> <text>Permit the organization the opportunity to correct the deficiencies by a specified date; or</text> </paragraph> <paragraph num="(2)"> <text>Impose a civil money penalty of up to $500 per day not to exceed $15,000 in one month until compliance is achieved.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the Department permits an organization the opportunity to correct the deficiencies by a specific date, and the organization fails to comply, the Department may impose a civil penalty of up to $500 for each day of violation until the organization has submitted sufficient documentation of correction of the deficiency not to exceed $15,000 in 1 month.</text> </paragraph> <paragraph num="G."> <text>In determining whether a civil money penalty is to be imposed and in setting the amount of the civil money penalty, the Department shall consider each of the following:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violation or violations;</text> </paragraph> <paragraph num="(2)"> <text>The extent to which the deficiency or deficiencies are part of an ongoing pattern;</text> </paragraph> <paragraph num="(3)"> <text>The organization’s history with the Department, including any prior history of compliance or any prior actions that would indicate whether the violation is an isolated occurrence or represents a pattern of behavior;</text> </paragraph> <paragraph num="(4)"> <text>The efforts made by the organization to correct the violations and any continuation of conduct after notification of possible violations;</text> </paragraph> <paragraph num="(5)"> <text>The organization’s level of cooperation with the Department or its agents as it relates to the review of the program;</text> </paragraph> <paragraph num="(6)"> <text>The degree of risk to the health, life, or safety of individuals as a result of the violations; and</text> </paragraph> <paragraph num="(7)"> <text>Any other reasonable mitigating factors.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Department shall give consideration to the extent to which the organization’s size, operations, or financial condition:</text> <paragraph num="(1)"> <text>May have contributed to the violations; and</text> </paragraph> <paragraph num="(2)"> <text>May affect the organization’s ability to provide care and continue program operations after payment of a civil money penalty.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the civil money penalty is imposed under this chapter, the Department shall issue a written notice to the organization operating the program that:</text> <paragraph num="(1)"> <text>States the total amount of the civil money penalties being imposed; and</text> </paragraph> <paragraph num="(2)"> <text>Includes the following information:</text> <paragraph num="(a)"> <text>Each regulation or statute violated;</text> </paragraph> <paragraph num="(b)"> <text>The amount of each civil money penalty imposed for each violation;</text> </paragraph> <paragraph num="(c)"> <text>The manner in which the amount of the civil money penalty was calculated; and</text> </paragraph> <paragraph num="(d)"> <text>The organization’s right to request a hearing in accordance with COMAR 10.63.06; and</text> </paragraph> <paragraph num="(e)"> <text>The organization’s appeal rights.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>The notice shall be sent to the organization, owner, resident agent, and Board of Directors, as appropriate, by certified mail.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Penalty for Unlicensed Operation."> <text>An organization that operates or purports to operate a service or site without a license that is required pursuant to this subtitle may be assessed a civil money penalty by the Department of $1,000 per day of operation per location site or service.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Civil Money Penalty — Appeal."> <paragraph num="A."> <text>An organization aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with COMAR 10.63.06.</text> </paragraph> <paragraph num="B."> <text>If the hearing affirms the imposition of the penalty, the Secretary shall issue a final order which shall state the basis on which the order is made, the amount of the civil money penalty imposed, and the manner in which the amount of the civil money penalty was calculated.</text> </paragraph> <paragraph num="C."> <text>After exhaustion of all appeals, an organization shall pay a civil money penalty to the Department within 10 days after the organization receives a final order that affirms the imposition of the civil money penalty.</text> </paragraph> <paragraph num="D."> <text>The Department, at its discretion, may agree to accept a repayment schedule, which may include a discount for timely payments.</text> </paragraph> <paragraph num="E."> <text>If an organization does not pay the civil money penalty to the Department after receiving the final order or according to a negotiated repayment schedule:</text> <paragraph num="(1)"> <text>The balance due shall be referred to the Central Collection Unit; and</text> </paragraph> <paragraph num="(2)"> <text>The organization and its programs may be subject to licensing action.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§7.5-205(b)(2)—(3), (d), 7.5-402(a)(6), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 14, 2025 (52:7 Md. R. 323)</annotation> </annotations> </chapter> </subtitle> <subtitle num="64" heading="Board of Nursing — Licensed Direct-Entry Midwives"> <chapter num="01" heading="Practice of Licensed Direct-Entry Midwives"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accompany the patient to the hospital” means, in the case of a transfer of care to a hospital, the direct-entry midwife:</text> <paragraph num="(a)"> <text>If possible, will ride in the ambulance with the patient; or</text> </paragraph> <paragraph num="(b)"> <text>Travel by other means to the hospital.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“ACME” means the Accreditation Commission for Midwifery Education or a successor organization that is:</text> <paragraph num="(a)"> <text>An accrediting agency for nurse-midwifery and direct-entry midwifery education programs; and</text> </paragraph> <paragraph num="(b)"> <text>Approved by the United States Department of Education.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“AIMM” means the Association of Independent Midwives of Maryland or a successor organization that is a professional organization representing independent midwives in the State.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the State Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>“Committee” means the Direct-Entry Midwifery Advisory Committee established under Health Occupations Article, §8-6C-11, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Electronic device” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephone;</text> </paragraph> <paragraph num="(b)"> <text>Telephone answering device;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machine, photocopier, and scanner for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Computer.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Health care practitioner” means an individual certified or licensed under Health Occupations Article, Annotated Code of Maryland as a:</text> <paragraph num="(a)"> <text>Nurse-midwife;</text> </paragraph> <paragraph num="(b)"> <text>Nurse practitioner; or</text> </paragraph> <paragraph num="(c)"> <text>Physician.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Health care provider” means a health care practitioner or a hospital and the agents or employees of a health care practitioner or a hospital.</text> </paragraph> <paragraph num="(9)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>Licensed Direct-Entry Midwife.</text> <paragraph num="(a)"> <text>“Licensed direct-entry midwife” means an individual who has been granted a license under Health Occupations Article, Title 8, Annotated Code of Maryland, to practice direct-entry midwifery.</text> </paragraph> <paragraph num="(b)"> <text>“Licensed direct-entry midwife” does not include a licensed registered nurse certified as a nurse-midwife under Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>“Low-risk pregnancy” means a pregnancy, labor, and delivery and postpartum, newborn, and interconceptional care that does not include a condition that requires a mandatory transfer under Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“MEAC” means the Midwifery Education and Accreditation Council or a successor organization that is a national accreditation agency for midwifery education approved by the United States Department of Education.</text> </paragraph> <paragraph num="(13)"> <text>“NARM” means the North American Registry of Midwives or a successor organization approved by the Board that is an international certification agency that establishes and administers certification for the certified professional midwife credential.</text> </paragraph> <paragraph num="(14)"> <text>“Patient” means:</text> <paragraph num="(a)"> <text>A woman for whom a licensed direct-entry midwife performs services: and</text> </paragraph> <paragraph num="(b)"> <text>A woman’s newborn for the purpose of perinatal or postpartum care.</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Postpartum period” means the first 6 weeks after delivery.</text> </paragraph> <paragraph num="(16)"> <text>“Practice direct-entry midwifery” means:</text> <paragraph num="(a)"> <text>Providing maternity care that is consistent with a midwife’s training, education, and experience;</text> </paragraph> <paragraph num="(b)"> <text>Identifying and referring patients who require medical care to an appropriate health care provider; and</text> </paragraph> <paragraph num="(c)"> <text>Includes the activities described in Regulation .02 of this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope of Practice."> <text>The practice of direct-entry midwifery includes:</text> <paragraph num="A."> <text>Providing the necessary supervision, care, and advice to a patient during a low-risk pregnancy, labor, delivery, and postpartum period;</text> </paragraph> <paragraph num="B."> <text>Newborn care authorized under Health Occupations Article, §8-6C-02, Annotated Code of Maryland, provided in a manner that is:</text> <paragraph num="(1)"> <text>Consistent with national direct-entry midwifery standards; and</text> </paragraph> <paragraph num="(2)"> <text>Based on the acquisition of clinical skills necessary for the care of pregnant women and newborns, including antepartum, intrapartum, and postpartum care;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Obtaining informed consent to provide services to the patient;</text> </paragraph> <paragraph num="D."> <text>Discussing:</text> <paragraph num="(1)"> <text>Any general risk factors associated with the services to be provided;</text> </paragraph> <paragraph num="(2)"> <text>Any specific risk factors pertaining to the health and circumstances of the individual patient;</text> </paragraph> <paragraph num="(3)"> <text>Conditions that preclude care by a licensed direct-entry midwife; and</text> </paragraph> <paragraph num="(4)"> <text>The conditions under which consultation, transfer of care, or transport of the patient must be implemented;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Obtaining a health history of the patient, including a travel history, and performing a physical examination;</text> </paragraph> <paragraph num="F."> <text>Developing a written plan of care specific to the patient, to ensure continuity of care throughout the antepartum, intrapartum, and postpartum periods that includes:</text> <paragraph num="(1)"> <text>A plan for the management of any specific risk factors pertaining to the individual health and circumstances of the individual patient; and</text> </paragraph> <paragraph num="(2)"> <text>A plan to be followed in the event of an emergency, including a plan for transportation;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Evaluating the results of patient care;</text> </paragraph> <paragraph num="H."> <text>Consulting and collaborating with a health care practitioner regarding the care of a patient, and referring and transferring care to a health care provider, as required;</text> </paragraph> <paragraph num="I."> <text>Referral of all patients, within 72 hours after delivery, to a pediatric health care practitioner for care of the newborn;</text> </paragraph> <paragraph num="J."> <text>As approved by the Board, in accordance with Regulation .08 of this chapter:</text> <paragraph num="(1)"> <text>Obtaining and administering medications; and</text> </paragraph> <paragraph num="(2)"> <text>Obtaining and using equipment and devices;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Obtaining appropriate screening and testing, including laboratory tests, urinalysis, and ultrasound;</text> </paragraph> <paragraph num="L."> <text>Providing prenatal care during the antepartum period, with consultation or referral as required;</text> </paragraph> <paragraph num="M."> <text>Providing care during the intrapartum period, including:</text> <paragraph num="(1)"> <text>Monitoring and evaluating the condition of the patient and fetus;</text> </paragraph> <paragraph num="(2)"> <text>At the onset of active labor notifying the pediatric health care practitioner, by any electronic device, that delivery is imminent;</text> </paragraph> <paragraph num="(3)"> <text>Performing emergency procedures, including:</text> <paragraph num="(a)"> <text>Administering approved medications;</text> </paragraph> <paragraph num="(b)"> <text>Administering intravenous fluids for stabilization;</text> </paragraph> <paragraph num="(c)"> <text>Performing an emergency episiotomy; and</text> </paragraph> <paragraph num="(d)"> <text>Providing care while on the way to a hospital under circumstances in which emergency medical services have not been activated;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Activating emergency medical services for an emergency; and</text> </paragraph> <paragraph num="(5)"> <text>Delivering in an out-of-hospital setting;</text> </paragraph> </paragraph> <paragraph num="N."> <text>Participating in peer review as required under Regulation .16 of this chapter;</text> </paragraph> <paragraph num="O."> <text>Providing care during the postpartum period, including:</text> <paragraph num="(1)"> <text>Suturing of first and second degree perineal or labial lacerations or suturing of an episiotomy with the administration of a local anesthetic; and</text> </paragraph> <paragraph num="(2)"> <text>Making further contact with the patient within 48 hours, within 2 weeks, and at 6 weeks after the delivery to assess for:</text> <paragraph num="(a)"> <text>Hemorrhage;</text> </paragraph> <paragraph num="(b)"> <text>Preeclampsia;</text> </paragraph> <paragraph num="(c)"> <text>Thrombo-embolism;</text> </paragraph> <paragraph num="(d)"> <text>Infection; and</text> </paragraph> <paragraph num="(e)"> <text>Emotional well-being;</text> </paragraph> </paragraph> </paragraph> <paragraph num="P."> <text>Providing routine care for the newborn for up to 72 hours after delivery, exclusive of administering immunizations, including:</text> <paragraph num="(1)"> <text>Immediate care at birth, including:</text> <paragraph num="(a)"> <text>Resuscitating as needed;</text> </paragraph> <paragraph num="(b)"> <text>Performing a newborn examination; and</text> </paragraph> <paragraph num="(c)"> <text>Administering intramuscular vitamin K and eye ointment for prevention of ophthalmia neonatorum;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assessing newborn feeding and hydration;</text> </paragraph> <paragraph num="(3)"> <text>Performing metabolic screening and reporting on the screening in accordance with COMAR 10.52.12;</text> </paragraph> <paragraph num="(4)"> <text>Performing critical congenital heart disease screening and reporting on the screening in accordance with COMAR 10.52.12;</text> </paragraph> <paragraph num="(5)"> <text>If unable to perform the screening required under §P(3) or (4) of this regulation, referring the newborn to a pediatric health care practitioner to perform the screening within 24 to 48 hours after delivery;</text> </paragraph> <paragraph num="(6)"> <text>Administering any other required newborn test, medication, or treatment required by the Department if authorized by the formulary in Regulation .07 of this chapter; and</text> </paragraph> <paragraph num="(7)"> <text>Referring the infant to an audiologist for a hearing screening in accordance with COMAR 10.52.12;</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Within 24 hours after delivery, notifying a pediatric health care practitioner, by any electronic device, of the delivery;</text> </paragraph> <paragraph num="R."> <text>Within 72 hours after delivery:</text> <paragraph num="(1)"> <text>Referring the newborn to a pediatric health care practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>Transferring health records to the pediatric health care practitioner, including documentation of the performance of the screenings required under this regulation;</text> </paragraph> </paragraph> <paragraph num="S."> <text>Providing the following care of the newborn beyond the first 72 hours after delivery:</text> <paragraph num="(1)"> <text>Weight checks and general observation of the newborn’s activity, with abnormal findings communicated to the newborn’s pediatric health care practitioner;</text> </paragraph> <paragraph num="(2)"> <text>Assessment of newborn feeding and hydration; and</text> </paragraph> <paragraph num="(3)"> <text>Breastfeeding support and counseling; and</text> </paragraph> </paragraph> <paragraph num="T."> <text>Providing limited services to the patient after the postpartum period, including:</text> <paragraph num="(1)"> <text>Breastfeeding support and counseling; and</text> </paragraph> <paragraph num="(2)"> <text>Counseling and referral for all family planning methods.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope of Practice — Prohibitions."> <paragraph num="A."> <text>The practice of direct-entry midwifery does not include:</text> <paragraph num="(1)"> <text>Pharmacological induction or augmentation of labor or artificial rupture of membranes before the onset of labor;</text> </paragraph> <paragraph num="(2)"> <text>Surgical delivery or any surgery except an emergency episiotomy;</text> </paragraph> <paragraph num="(3)"> <text>Use of forceps or vacuum extractor;</text> </paragraph> <paragraph num="(4)"> <text>Except for the administration of a local anesthetic, administration of an anesthetic;</text> </paragraph> <paragraph num="(5)"> <text>Administration of any kind of narcotic analgesic; or</text> </paragraph> <paragraph num="(6)"> <text>Administration of any prescription medication not authorized in accordance with Regulation .07 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed direct-entry midwife may not assume care or continue to take responsibility for a patient’s pregnancy and birth care if a finding of any of the disorders or situations listed under §C of this regulation is found to be present:</text> <paragraph num="(1)"> <text>At the initial interview;</text> </paragraph> <paragraph num="(2)"> <text>During an examination of the patient;</text> </paragraph> <paragraph num="(3)"> <text>While obtaining a patient history or at subsequent prenatal visits;</text> </paragraph> <paragraph num="(4)"> <text>As a result of a laboratory or other test; or</text> </paragraph> <paragraph num="(5)"> <text>After consultation with another health care practitioner.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If any of the following disorders or situations exist, the licensed direct-entry midwife shall arrange for the orderly transfer of care to a health care practitioner:</text> <paragraph num="(1)"> <text>Diabetes mellitus, including uncontrolled gestational diabetes;</text> </paragraph> <paragraph num="(2)"> <text>Hyperthyroidism treated with medication;</text> </paragraph> <paragraph num="(3)"> <text>Uncontrolled hypothyroidism;</text> </paragraph> <paragraph num="(4)"> <text>Epilepsy with seizures or antiepileptic drug use during the previous 12 months;</text> </paragraph> <paragraph num="(5)"> <text>Coagulation disorders;</text> </paragraph> <paragraph num="(6)"> <text>Chronic pulmonary disease;</text> </paragraph> <paragraph num="(7)"> <text>Heart disease in which there are arrhythmias or murmurs except when, after evaluation, it is the opinion of a physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland, or a licensed nurse certified as a nurse-midwife or a nurse practitioner under Health Occupations Article, Title 8, Annotated Code of Maryland, that midwifery care may proceed;</text> </paragraph> <paragraph num="(8)"> <text>Hypertension, including pregnancy-induced hypertension (PIH);</text> </paragraph> <paragraph num="(9)"> <text>Renal disease;</text> </paragraph> <paragraph num="(10)"> <text>Except as otherwise provided in Health Occupations Article, §8-6C-04(a)(11), Annotated Code of Maryland, Rh sensitization with positive antibody titer;</text> </paragraph> <paragraph num="(11)"> <text>Previous uterine surgery, including a cesarean section or myomectomy;</text> </paragraph> <paragraph num="(12)"> <text>Indications that the fetus has died in utero;</text> </paragraph> <paragraph num="(13)"> <text>Premature labor (gestation less than 37 weeks);</text> </paragraph> <paragraph num="(14)"> <text>Multiple gestation;</text> </paragraph> <paragraph num="(15)"> <text>Noncephalic presentation at or after 38 weeks;</text> </paragraph> <paragraph num="(16)"> <text>Placenta previa or abruption;</text> </paragraph> <paragraph num="(17)"> <text>Preeclampsia;</text> </paragraph> <paragraph num="(18)"> <text>Severe anemia, defined as hemoglobin less than 10 g/dL;</text> </paragraph> <paragraph num="(19)"> <text>Uncommon diseases and disorders, including:</text> <paragraph num="(a)"> <text>Addison’s disease;</text> </paragraph> <paragraph num="(b)"> <text>Cushing’s disease;</text> </paragraph> <paragraph num="(c)"> <text>Systemic lupus erythematosus;</text> </paragraph> <paragraph num="(d)"> <text>Antiphospholipid syndrome;</text> </paragraph> <paragraph num="(e)"> <text>Scleroderma;</text> </paragraph> <paragraph num="(f)"> <text>Rheumatoid arthritis;</text> </paragraph> <paragraph num="(g)"> <text>Periarteritis nodosa;</text> </paragraph> <paragraph num="(h)"> <text>Marfan’s syndrome; and</text> </paragraph> <paragraph num="(i)"> <text>Other systemic and rare diseases and disorders, as determined by the Department;</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>AIDS/HIV;</text> </paragraph> <paragraph num="(21)"> <text>Hepatitis A through G and non-A through G;</text> </paragraph> <paragraph num="(22)"> <text>Acute toxoplasmosis infection, if the patient is symptomatic;</text> </paragraph> <paragraph num="(23)"> <text>Acute Rubella infection during pregnancy;</text> </paragraph> <paragraph num="(24)"> <text>Acute cytomegalovirus infection, if the patient is symptomatic;</text> </paragraph> <paragraph num="(25)"> <text>Acute Parvovirus infection, if the patient is symptomatic;</text> </paragraph> <paragraph num="(26)"> <text>Alcohol abuse, substance abuse, or prescription abuse during pregnancy;</text> </paragraph> <paragraph num="(27)"> <text>Continued daily tobacco use into the second trimester;</text> </paragraph> <paragraph num="(28)"> <text>Thrombosis;</text> </paragraph> <paragraph num="(29)"> <text>Inflammatory bowel disease that is not in remission;</text> </paragraph> <paragraph num="(30)"> <text>Primary herpes simplex virus, genital infection during pregnancy, or any active genital lesions at the time of delivery;</text> </paragraph> <paragraph num="(31)"> <text>Significant fetal congenital anomaly;</text> </paragraph> <paragraph num="(32)"> <text>Ectopic pregnancy;</text> </paragraph> <paragraph num="(33)"> <text>Prepregnancy body mass index (BMI) of less than 18.5 or 35 or more; or</text> </paragraph> <paragraph num="(34)"> <text>Post term maturity (gestational age 42 0/7 weeks and beyond).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Required Consultation."> <paragraph num="A."> <text>A licensed direct-entry midwife shall consult with a health care practitioner and document:</text> <paragraph num="(1)"> <text>The consultation;</text> </paragraph> <paragraph num="(2)"> <text>The recommendations of the consultation; and</text> </paragraph> <paragraph num="(3)"> <text>The discussion of the consultation with the client if any of the following conditions are present during prenatal care:</text> <paragraph num="(a)"> <text>Significant mental disease, including depression, bipolar disorder, schizophrenia, and other conditions that impair the ability of the patient to participate effectively in the patient’s care or that require the use of psychotropic drugs to control the condition;</text> </paragraph> <paragraph num="(b)"> <text>Second or third trimester bleeding;</text> </paragraph> <paragraph num="(c)"> <text>Intermittent use of alcohol into the second trimester;</text> </paragraph> <paragraph num="(d)"> <text>Asthma;</text> </paragraph> <paragraph num="(e)"> <text>Diet-controlled gestational diabetes;</text> </paragraph> <paragraph num="(f)"> <text>History of genetic problems, intrauterine death after 20 weeks’ gestation, or stillbirth;</text> </paragraph> <paragraph num="(g)"> <text>Abnormal Pap smear;</text> </paragraph> <paragraph num="(h)"> <text>Possible ectopic pregnancy;</text> </paragraph> <paragraph num="(i)"> <text>Tuberculosis;</text> </paragraph> <paragraph num="(j)"> <text>Controlled hypothyroidism, being treated with thyroid replacement and euthyroid, and with thyroid test numbers in the normal range;</text> </paragraph> <paragraph num="(k)"> <text>Rh sensitization with positive antibody titer;</text> </paragraph> <paragraph num="(l)"> <text>Breech presentation between 35 and 38 weeks;</text> </paragraph> <paragraph num="(m)"> <text>Transverse lie or other abnormal presentation between 35 and 38 weeks;</text> </paragraph> <paragraph num="(n)"> <text>Premature rupture of membranes at 37 weeks or less;</text> </paragraph> <paragraph num="(o)"> <text>Small for gestational age or large for gestational age fetus;</text> </paragraph> <paragraph num="(p)"> <text>Polyhydramnios or oligohydramnios;</text> </paragraph> <paragraph num="(q)"> <text>Previous LEEP procedure or cone biopsy;</text> </paragraph> <paragraph num="(r)"> <text>Previous obstetrical problems, including uterine abnormalities, placental abruption, placenta accreta, obstetric hemorrhage, incompetent cervix, or preterm delivery for any reason;</text> </paragraph> <paragraph num="(s)"> <text>Post-term maturity (41 0/7 to 6/7 weeks gestational age);</text> </paragraph> <paragraph num="(t)"> <text>Inflammatory bowel disease, in remission; or</text> </paragraph> <paragraph num="(u)"> <text>Primary herpes simplex virus, infection or any active infection at time of delivery.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Any changes in the plan of care following a consultation in accordance with §A of this regulation shall be documented in the patient’s plan of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Required Transfer of Care."> <paragraph num="A."> <text>Except for §B of this regulation, a licensed direct-entry midwife shall arrange immediate emergency transfer to a hospital if:</text> <paragraph num="(1)"> <text>The patient requests transfer; or</text> </paragraph> <paragraph num="(2)"> <text>The patient or newborn is determined to have any of the following conditions during labor, delivery, or the immediate postpartum period:</text> <paragraph num="(a)"> <text>Unforeseen noncephalic presentation;</text> </paragraph> <paragraph num="(b)"> <text>Unforeseen multiple gestation;</text> </paragraph> <paragraph num="(c)"> <text>Nonreassuring fetal heart rate or pattern, including:</text> <paragraph num="(i)"> <text>Tachycardia</text> </paragraph> <paragraph num="(ii)"> <text>Bradycardia;</text> </paragraph> <paragraph num="(iii)"> <text>Significant change in baseline; or</text> </paragraph> <paragraph num="(iv)"> <text>Persistent late or severe variable decelerations;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Prolapsed cord;</text> </paragraph> <paragraph num="(e)"> <text>Unresolved maternal hemorrhage;</text> </paragraph> <paragraph num="(f)"> <text>Retained placenta;</text> </paragraph> <paragraph num="(g)"> <text>Signs of fetal or maternal infection;</text> </paragraph> <paragraph num="(h)"> <text>Patient with a third or fourth degree laceration or a laceration beyond the licensed direct-entry midwife’s ability to repair;</text> </paragraph> <paragraph num="(i)"> <text>Apgar of less than seven at 5 minutes;</text> </paragraph> <paragraph num="(j)"> <text>Obvious congenital anomalies;</text> </paragraph> <paragraph num="(k)"> <text>Need for chest compressions during neonatal resuscitation;</text> </paragraph> <paragraph num="(l)"> <text>Newborn with persistent central cyanosis;</text> </paragraph> <paragraph num="(m)"> <text>Newborn with persistent grunting and retractions;</text> </paragraph> <paragraph num="(n)"> <text>Newborn with abnormal vital signs;</text> </paragraph> <paragraph num="(o)"> <text>Gross or thick meconium staining, when discovered; or</text> </paragraph> <paragraph num="(p)"> <text>Newborn with excessive dehydration due to inability to feed.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If transfer is not possible because of imminent delivery, the licensed direct-entry midwife shall consult with a health care provider for guidance on further management of the patient and to determine when transfer may be safely arranged, if required.</text> </paragraph> <paragraph num="C."> <text>A licensed direct-entry midwife shall immediately transfer the care of a patient to a health care provider for the treatment of any significant postpartum morbidity, including:</text> <paragraph num="(1)"> <text>Uncontrolled postpartum hemorrhage;</text> </paragraph> <paragraph num="(2)"> <text>Preeclampsia;</text> </paragraph> <paragraph num="(3)"> <text>Thrombo-embolism;</text> </paragraph> <paragraph num="(4)"> <text>An infection; or</text> </paragraph> <paragraph num="(5)"> <text>A postpartum mental health disorder.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed direct-entry midwife who is required to transfer care of a patient under this regulation may continue other aspects of postpartum care in consultation with the treating health care practitioner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Assistant for Home Birth."> <text>At the time of delivery, a licensed direct-entry midwife shall be assisted by a second individual who has:</text> <paragraph num="A."> <text>Completed the American Academy of Pediatrics/American Heart Association Neonatal Resuscitation Program (NRP) within the previous 2 years; and</text> </paragraph> <paragraph num="B."> <text>The skills and equipment necessary to perform a full resuscitation of the newborn in accordance with the principles of NRP.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Licensed Direct-Entry Midwifery Formulary, Equipment, and Medical Devices."> <paragraph num="A."> <text>As approved by the Board, in accordance with Health Occupations Article §8-6C-02(b)(8), Annotated Code of Maryland, a licensed direct-entry midwife may:</text> <paragraph num="(1)"> <text>Obtain and administer medications; and</text> </paragraph> <paragraph num="(2)"> <text>Obtain and use equipment and devices for the practice of midwifery.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following medications are approved by the Board:</text> <paragraph num="(1)"> <text>Vitamin K1 (phylloquinone, phytonadione);</text> </paragraph> <paragraph num="(2)"> <text>Rho D immune globulin;</text> </paragraph> <paragraph num="(3)"> <text>Oxytocin (Pitocin);</text> </paragraph> <paragraph num="(4)"> <text>Methylergonovine (Methergine);</text> </paragraph> <paragraph num="(5)"> <text>Misoprostol (Cytotec);</text> </paragraph> <paragraph num="(6)"> <text>Erythromycin ophthalmic ointment USP (0.5%);</text> </paragraph> <paragraph num="(7)"> <text>Oxygen;</text> </paragraph> <paragraph num="(8)"> <text>Local anesthetics (lidocaine HCI, cetacaine, novacaine (procaine));</text> </paragraph> <paragraph num="(9)"> <text>Epinephrine;</text> </paragraph> <paragraph num="(10)"> <text>Penicillin;</text> </paragraph> <paragraph num="(11)"> <text>Cefazolin;</text> </paragraph> <paragraph num="(12)"> <text>Sterile H2O Papules; and</text> </paragraph> <paragraph num="(13)"> <text>Intravenous Fluids including Lactated Ringer’s and normal saline.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The following devices are approved by the Board:</text> <paragraph num="(1)"> <text>Fetal heart rate dopplers;</text> </paragraph> <paragraph num="(2)"> <text>Syringes;</text> </paragraph> <paragraph num="(3)"> <text>Needles;</text> </paragraph> <paragraph num="(4)"> <text>Phlebotomy equipment;</text> </paragraph> <paragraph num="(5)"> <text>Suture and suturing equipment or supplies;</text> </paragraph> <paragraph num="(6)"> <text>Urinary catheters;</text> </paragraph> <paragraph num="(7)"> <text>Intravenous equipment;</text> </paragraph> <paragraph num="(8)"> <text>Amnihooks;</text> </paragraph> <paragraph num="(9)"> <text>Airway suction devices;</text> </paragraph> <paragraph num="(10)"> <text>Electronic fetal monitoring equipment;</text> </paragraph> <paragraph num="(11)"> <text>Toco monitoring equipment;</text> </paragraph> <paragraph num="(12)"> <text>Neonatal and adult resuscitation equipment;</text> </paragraph> <paragraph num="(13)"> <text>Glucose monitoring equipment;</text> </paragraph> <paragraph num="(14)"> <text>Centrifuge;</text> </paragraph> <paragraph num="(15)"> <text>Hemoglobin/hematocrit monitoring equipment;</text> </paragraph> <paragraph num="(16)"> <text>Pulse oximeters, adult and neonatal;</text> </paragraph> <paragraph num="(17)"> <text>Birth supplies including medical grade birthing tubs and birthing stools;</text> </paragraph> <paragraph num="(18)"> <text>Blood pressure equipment;</text> </paragraph> <paragraph num="(19)"> <text>Urinalysis supplies;</text> </paragraph> <paragraph num="(20)"> <text>Stethoscopes, adult and neonatal;</text> </paragraph> <paragraph num="(21)"> <text>Sterile surgical instruments;</text> </paragraph> <paragraph num="(22)"> <text>Speculums;</text> </paragraph> <paragraph num="(23)"> <text>Eldon Cards;</text> </paragraph> <paragraph num="(24)"> <text>Nitrazine paper, amniswabs and other amniotic fluid detection equipment;</text> </paragraph> <paragraph num="(25)"> <text>Thermometers;</text> </paragraph> <paragraph num="(26)"> <text>Laboratory specimen collection equipment;</text> </paragraph> <paragraph num="(27)"> <text>Sterilization supplies and equipment;</text> </paragraph> <paragraph num="(28)"> <text>Equipment and devices for critical congenital heart screening;</text> </paragraph> <paragraph num="(29)"> <text>Equipment and devices for hearing screening;</text> </paragraph> <paragraph num="(30)"> <text>Supplies to collect newborn metabolic screening;</text> </paragraph> <paragraph num="(31)"> <text>Other equipment and devices as approved by the Board;</text> </paragraph> <paragraph num="(32)"> <text>Breast pumps;</text> </paragraph> <paragraph num="(33)"> <text>Compression stockings and belts;</text> </paragraph> <paragraph num="(34)"> <text>Maternity belts; and</text> </paragraph> <paragraph num="(35)"> <text>Diaphragms and cervical caps.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="License Required and Exceptions."> <paragraph num="A."> <text>An individual shall be licensed by the Board before the individual may practice direct-entry midwifery in the State.</text> </paragraph> <paragraph num="B."> <text>This regulation does not apply to:</text> <paragraph num="(1)"> <text>An individual who assists at a birth in an emergency;</text> </paragraph> <paragraph num="(2)"> <text>An individual who is licensed as a health care practitioner whose scope of practice allows the individual to practice direct-entry midwifery; or</text> </paragraph> <paragraph num="(3)"> <text>A student who is practicing direct-entry midwifery while engaged in a Board-approved clinical midwife educational experience under the supervision of a licensed direct-entry midwife.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Patient’s Refusal to Transfer Care."> <paragraph num="A."> <text>If a patient chooses to give birth at home in a situation prohibited by this chapter or in which a licensed direct-entry midwife recommends transfer, the licensed direct-entry midwife shall:</text> <paragraph num="(1)"> <text>Transfer care of the patient to a health care practitioner; and</text> </paragraph> <paragraph num="(2)"> <text>Complete the standard form developed under Regulation .10 of this chapter and:</text> <paragraph num="(a)"> <text>Submit the completed form to the accepting health care practitioner; and</text> </paragraph> <paragraph num="(b)"> <text>Cease to take responsibility for the patient’s pregnancy care within 1 week after the transfer.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If birth is imminent and the patient refuses to be transferred after the licensed direct-entry midwife determines that a transfer is necessary, the licensed direct-entry midwife shall:</text> <paragraph num="(1)"> <text>Call 9-1-1 and remain with the patient until emergency services personnel arrive; and</text> </paragraph> <paragraph num="(2)"> <text>Transfer care and give a verbal report of the care provided to the emergency medical services providers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Plan of Care."> <paragraph num="A."> <text>A licensed direct-entry midwife shall develop a general written plan for:</text> <paragraph num="(1)"> <text>Emergency transfer of a patient, a newborn, or both;</text> </paragraph> <paragraph num="(2)"> <text>Transport of a newborn to a newborn nursery or neonatal intensive care nursery; and</text> </paragraph> <paragraph num="(3)"> <text>Transport of a patient to an appropriate hospital with a labor and delivery unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Committee shall review and recommend approval to the Board of the plan required under §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>The plan required under §A of this regulation shall be provided to any hospital identified in the plan approved by the Committee.</text> </paragraph> <paragraph num="D."> <text>In addition to the general written plan required under §A of this regulation, a licensed direct-entry midwife shall prepare a plan that is specific to each patient and share the plan with the patient.</text> </paragraph> <paragraph num="E."> <text>The plan required under §D of this regulation shall:</text> <paragraph num="(1)"> <text>Include procedures and processes to be undertaken in the event of an emergency for the mother, the newborn, or both;</text> </paragraph> <paragraph num="(2)"> <text>Identify the hospital nearest to the address of the planned home birth that has a labor and delivery unit;</text> </paragraph> <paragraph num="(3)"> <text>Include a care plan for the newborn; and</text> </paragraph> <paragraph num="(4)"> <text>Identify the pediatric health care practitioner who will be notified after delivery in accordance with Regulation .02 of this chapter to receive the transfer of care of the newborn.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Each direct-entry midwife shall use the standard form approved by the Board for all cases in which a transfer occurs during prenatal care, labor, or postpartum.</text> </paragraph> <paragraph num="G."> <text>After a decision to transport a patient has been made, the licensed direct-entry midwife shall:</text> <paragraph num="(1)"> <text>Call the receiving health care provider;</text> </paragraph> <paragraph num="(2)"> <text>Inform the health care provider of the incoming patient;</text> </paragraph> <paragraph num="(3)"> <text>Accompany the patient to the hospital; and</text> </paragraph> <paragraph num="(4)"> <text>On arrival at the hospital, provide to the staff of the hospital;</text> <paragraph num="(a)"> <text>The standard form developed under §D of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>The complete medical records of the patient and newborn; and</text> </paragraph> <paragraph num="(c)"> <text>A verbal summary of the care provided to the patient and newborn by the licensed direct-entry midwife.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Informed Consent Agreements."> <paragraph num="A."> <text>Before initiating care, a licensed direct-entry midwife shall obtain a signed copy of the Board-approved standardized informed consent agreement.</text> </paragraph> <paragraph num="B."> <text>The agreement developed under §A of this regulation shall include acknowledgment by the patient of receipt, at a minimum, of the following:</text> <paragraph num="(1)"> <text>The licensed direct-entry midwife’s training and experience;</text> </paragraph> <paragraph num="(2)"> <text>Instructions for obtaining a copy of the regulations under this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Instructions for obtaining a copy of the NARM certification requirements;</text> </paragraph> <paragraph num="(4)"> <text>Instructions for filing a complaint with the Board;</text> </paragraph> <paragraph num="(5)"> <text>Notice of whether the licensed direct-entry midwife has professional liability insurance coverage;</text> </paragraph> <paragraph num="(6)"> <text>A description of the procedures, benefits, and risks of home births, including those conditions that may arise during delivery; and</text> </paragraph> <paragraph num="(7)"> <text>Any other information that the Board requires.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Required Reports."> <paragraph num="A."> <text>Annually, beginning October 1, 2016, a licensed direct-entry midwife shall submit a report to the Committee, in a form specified by the Board, of the following information regarding cases in which the licensed direct-entry midwife assisted during the previous fiscal year ending June 30, when the intended place of birth was an out-of-hospital setting:</text> <paragraph num="(1)"> <text>The total number of patients served as primary caregiver at the onset of care;</text> </paragraph> <paragraph num="(2)"> <text>The number, by county, of live births attended as primary caregiver;</text> </paragraph> <paragraph num="(3)"> <text>The number, by county, of cases of fetal demise, infant deaths, and maternal deaths attended as primary caregiver at the discovery of the demise or death;</text> </paragraph> <paragraph num="(4)"> <text>The number of women whose primary care was transferred to another health care practitioner during the antepartum period and the reason for the transfer;</text> </paragraph> <paragraph num="(5)"> <text>The number, reason for, and outcome of each nonemergency hospital transfer during the intrapartum or postpartum period;</text> </paragraph> <paragraph num="(6)"> <text>The number, reason for, and outcome of each urgent or emergency transport of an expectant mother in the antepartum period;</text> </paragraph> <paragraph num="(7)"> <text>The number, reason for, and outcome of each urgent or emergency transport of an infant or mother during the intrapartum or immediate postpartum period;</text> </paragraph> <paragraph num="(8)"> <text>The number of planned out-of-hospital births at the onset of labor and the number of births completed in an out-of-hospital setting;</text> </paragraph> <paragraph num="(9)"> <text>A brief description of any complications resulting in the morbidity or mortality of a mother or a neonate; and</text> </paragraph> <paragraph num="(10)"> <text>Any other information required by the Board in this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall send a written notice of noncompliance to a licensee who fails to meet the reporting requirements under §A of this regulation.</text> </paragraph> <paragraph num="C."> <text>A licensed direct-entry midwife who fails to comply with the reporting requirements under this regulation may not be allowed to renew their license until the information required under §A of this regulation is reported.</text> </paragraph> <paragraph num="D."> <text>The Committee shall maintain the confidentiality of any report submitted under §A of this regulation.</text> </paragraph> <paragraph num="E."> <text>In addition to the report required under this regulation, a licensed direct-entry midwife shall be subject to the same State reporting requirements as other health care practitioners who provide care to individuals in accordance with Health-General Article and Health Occupations Article, Annotated Code of Maryland, and COMAR.</text> </paragraph> <paragraph num="F."> <text>A licensed direct-entry midwife attending an out-of-hospital delivery shall:</text> <paragraph num="(1)"> <text>For any live birth, complete and submit a birth certificate in accordance with Health-General Article, §4-208, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>For any death, make all medical records available and communicate relevant circumstances of the death to the individual responsible for completing the certificate of death under Health-General Article, §§4-212 and 4-213, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Direct-Entry Midwifery Advisory Committee."> <paragraph num="A."> <text>There is a Direct-Entry Midwifery Advisory Committee within the Board.</text> </paragraph> <paragraph num="B."> <text>Committee Appointments.</text> <paragraph num="(1)"> <text>The Committee shall consist of seven members appointed by the Board, in accordance with the following.</text> <paragraph num="(a)"> <text>Three shall be licensed direct-entry midwives;</text> </paragraph> <paragraph num="(b)"> <text>Two shall be licensed registered nurses certified as nurse-midwives;</text> </paragraph> <paragraph num="(c)"> <text>One shall be a representative of the Maryland Hospital Association; and</text> </paragraph> <paragraph num="(d)"> <text>One shall be a consumer member who meets the requirements stated in Health Occupations Article, §8-6C-11, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>AIMM List.</text> <paragraph num="(a)"> <text>The Board shall appoint the licensed direct-entry midwife members of the Committee from a list of qualified individuals submitted to the Board by AIMM.</text> </paragraph> <paragraph num="(b)"> <text>The Board may request an additional list of qualified individuals from AIMM if the initial list is determined to be inadequate.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>General Requirement for Committee Membership. A member of the Committee shall be a:</text> <paragraph num="(1)"> <text>Citizen of the United States; and</text> </paragraph> <paragraph num="(2)"> <text>Resident of the State.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Additional Requirements for a Licensed Direct-Entry Midwife Member. A licensed direct-entry midwife member of the Committee:</text> <paragraph num="(1)"> <text>Shall meet the licensure requirements of Regulation .15 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>May not be a licensed registered nurse who is certified as a nurse-midwife.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Additional Requirements for the Consumer Member.</text> <paragraph num="(1)"> <text>The consumer member shall be a member of the general public.</text> </paragraph> <paragraph num="(2)"> <text>The consumer member may not be or ever have been;</text> <paragraph num="(a)"> <text>A licensed direct-entry midwife;</text> </paragraph> <paragraph num="(b)"> <text>A licensed registered nurse certified as a midwife;</text> </paragraph> <paragraph num="(c)"> <text>A health care practitioner who is directly involved with pregnancy or labor; or</text> </paragraph> <paragraph num="(d)"> <text>In training to be a:</text> <paragraph num="(i)"> <text>Licensed direct-entry midwife;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed registered nurse certified as a midwife; or</text> </paragraph> <paragraph num="(iii)"> <text>Health care practitioner who is directly involved with pregnancy or labor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The consumer member may not have a household member who is:</text> <paragraph num="(a)"> <text>A licensed direct-entry midwife:</text> </paragraph> <paragraph num="(b)"> <text>A licensed registered nurse who is certified as a nurse-midwife;</text> </paragraph> <paragraph num="(c)"> <text>A health care practitioner who is directly involved with pregnancy or labor; or</text> </paragraph> <paragraph num="(d)"> <text>In training to be a:</text> <paragraph num="(i)"> <text>Licensed direct-entry midwife;</text> </paragraph> <paragraph num="(ii)"> <text>Licensed nurse who is certified as a nurse-midwife; or</text> </paragraph> <paragraph num="(iii)"> <text>Health care practitioner who is directly involved with pregnancy or labor.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The consumer member may not:</text> <paragraph num="(a)"> <text>Participate or ever have participated in a commercial or professional field related to the practice of direct-entry midwifery;</text> </paragraph> <paragraph num="(b)"> <text>Have a household member who participates in a commercial or professional field related to the practice of direct-entry midwifery; or</text> </paragraph> <paragraph num="(c)"> <text>Have, or have had within 2 years before appointment, a substantial financial interest in a person who is regulated by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Committee Chair. The Committee shall elect a Chair from among its members to a 2-year term.</text> </paragraph> <paragraph num="G."> <text>Terms.</text> <paragraph num="(1)"> <text>The term of a Committee member is 4 years.</text> </paragraph> <paragraph num="(2)"> <text>The terms of the members are staggered as required by the terms provided for members of the Committee on October 1, 2015.</text> </paragraph> <paragraph num="(3)"> <text>At the end of a term, a member continues to serve until a successor is appointed and qualifies.</text> </paragraph> <paragraph num="(4)"> <text>A member who is appointed after a term has begun serves only for the rest of the term and until a successor is appointed and qualifies.</text> </paragraph> <paragraph num="(5)"> <text>A member may not serve more than two consecutive full terms.</text> </paragraph> <paragraph num="(6)"> <text>To the extent practicable, the Board shall fill any vacancy on the Committee within 60 days of the date of the vacancy.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Committee Meetings.</text> <paragraph num="(1)"> <text>A majority of the full authorized membership of the Committee is a quorum.</text> </paragraph> <paragraph num="(2)"> <text>In addition to any other meeting requirements of Health Occupations Article, §8-6C-11, Annotated Code of Maryland, the Committee shall meet:</text> <paragraph num="(a)"> <text>At the request of the Executive Director of the Board; and</text> </paragraph> <paragraph num="(b)"> <text>As necessary to conduct Board or Committee business.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>Member Compensation. In accordance with Health Occupations Article, §8-6C-11, Annotated Code of Maryland, each member of the Committee is entitled to:</text> <paragraph num="(1)"> <text>Compensation, at a rate determined by the Board, for each day, or part of a day, on which the member is engaged in the duties of the Committee; and</text> </paragraph> <paragraph num="(2)"> <text>Reimbursement for expenses under the Standard State Travel Regulations.</text> </paragraph> </paragraph> <paragraph num="J."> <text>Removal of a Committee Member. The Board may remove a member:</text> <paragraph num="(1)"> <text>For incompetence or misconduct; or</text> </paragraph> <paragraph num="(2)"> <text>Who is absent from two successive Committee meetings without adequate reason.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Committee Duties."> <paragraph num="A."> <text>The Committee shall:</text> <paragraph num="(1)"> <text>Review applications for licensure as a licensed direct-entry midwife and make recommendations to the Board regarding applicants;</text> </paragraph> <paragraph num="(2)"> <text>Maintain a list of all licensed direct-entry midwives;</text> </paragraph> <paragraph num="(3)"> <text>Make recommendations to the Board regarding continuing education requirements for licensed direct-entry midwives;</text> </paragraph> <paragraph num="(4)"> <text>Review advertising by licensed direct-entry midwives and by institutions that offer a direct-entry midwife program and make recommendations to the Board, as necessary;</text> </paragraph> <paragraph num="(5)"> <text>Advise the Board on matters relating to the practice of direct-entry midwifery;</text> </paragraph> <paragraph num="(6)"> <text>Collect the reports required to be submitted by each licensed direct-entry midwife under Regulation .12 of this chapter;</text> </paragraph> <paragraph num="(7)"> <text>Make recommendations to the Board regarding regulations relating to the practice of direct-entry midwifery that are necessary to carry out the provisions of this chapter;</text> </paragraph> <paragraph num="(8)"> <text>At the request of the Board, investigate complaints against licensed direct-entry midwives; and</text> </paragraph> <paragraph num="(9)"> <text>Keep a record of the Committee’s proceedings.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Annually, beginning November 1, 2016, the Committee shall submit to the Board a report, without any personal identifying information, that includes, but is not limited to:</text> <paragraph num="(1)"> <text>A summary of the information included in reports submitted to the Committee by licensed direct-entry midwives under Regulation .12 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Any other information identified by the Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Annually, beginning December 1, 2016, the Board shall submit to the Senate Education, Health, and Environmental Affairs Committee and the House Health and Government Operations Committee, in accordance with State Government Article, §2-1246, Annotated Code of Maryland, a report to include the following:</text> <paragraph num="(1)"> <text>The report submitted to the Board under §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Any Committee recommendations regarding the continuation and improvement of the licensure of licensed direct-entry midwives in the State;</text> </paragraph> <paragraph num="(3)"> <text>Any recommendations regarding expanding the scope of practice of licensed direct-entry midwives; and</text> </paragraph> <paragraph num="(4)"> <text>Any recommendations, including recommendations for legislation, regarding the scope of practice of licensed direct-entry midwives to include vaginal birth after cesarean delivery.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Qualifications of Applicants for Initial Licensure."> <paragraph num="A."> <text>An applicant shall:</text> <paragraph num="(1)"> <text>Be of good moral character;</text> </paragraph> <paragraph num="(2)"> <text>Be a high school graduate or have completed equivalent education;</text> </paragraph> <paragraph num="(3)"> <text>Be 21 years old or older;</text> </paragraph> <paragraph num="(4)"> <text>Hold a current cardiopulmonary resuscitation (CPR) certification issued by the American Red Cross or the American Heart Association;</text> </paragraph> <paragraph num="(5)"> <text>Have completed in the past 2 years the American Academy of Pediatrics or American Heart Association Neonatal Resuscitation Program (NRP);</text> </paragraph> <paragraph num="(6)"> <text>Hold a current valid Certified Professional Midwife credential granted by NARM; and</text> </paragraph> <paragraph num="(7)"> <text>Have completed a midwifery education program as describe in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Midwifery Education Program. The applicant shall:</text> <paragraph num="(1)"> <text>Have completed a midwifery education program that is accredited by MEAC or ACME;</text> </paragraph> <paragraph num="(2)"> <text>Have completed the NARM Midwifery Bridge Certificate Program; or</text> </paragraph> <paragraph num="(3)"> <text>If the applicant was certified by NARM as a certified professional midwife on or before January 15, 2017, through a non-MEAC accredited program, but otherwise qualifies for licensure, provide:</text> <paragraph num="(a)"> <text>Verification of completion of NARM-approved clinical requirements; and</text> </paragraph> <paragraph num="(b)"> <text>Evidence of completion, in the past 2 years, of an additional 50 hours of continuing education units approved by the Board and accredited by MEAC, the American College of Nurse Midwives, or the Accrediting Council for Continuing Medical Education, which included:</text> <paragraph num="(i)"> <text>14 hours of obstetric emergency skills training such as a Birth Emergency Skills Training (BEST) or an Advanced Life Saving in Obstetrics (ALSO) course; and</text> </paragraph> <paragraph num="(ii)"> <text>36 hours of pharmacology, lab interpretation of pregnancy, antepartum complications, intrapartum complications, postpartum complications, and neonatal care courses.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Applications for Licenses and Issuance of Licenses."> <paragraph num="A."> <text>To apply for a license to practice direct-entry midwifery an applicant shall submit:</text> <paragraph num="(1)"> <text>To a criminal history records check (CHRC) in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>A completed application to the Board on the form that the Board requires; and</text> </paragraph> <paragraph num="(3)"> <text>Written, verified evidence that the requirement submissions to a CHRC in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland, is being met;</text> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to:</text> <paragraph num="(a)"> <text>An official certified or true test court documents; and</text> </paragraph> <paragraph num="(b)"> <text>A signed and dated explanation, written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(i)"> <text>Under §A(1) of this regulation;</text> </paragraph> <paragraph num="(ii)"> <text>In an answer to a question on the Board’s application form;</text> </paragraph> <paragraph num="(iii)"> <text>Any other source; and</text> </paragraph> <paragraph num="(iv)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) of this regulation is incomplete or insufficient; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>The initial application fee specified in Regulation .18 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to:</text> <paragraph num="(1)"> <text>Complete the application; and</text> </paragraph> <paragraph num="(2)"> <text>Provide all information and documentation required in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board under §A of this regulation within 12 months from the date the application is received by the Board, the application shall be void and the Board will no longer consider the applicant for licensure.</text> </paragraph> <paragraph num="D."> <text>To pursue licensure after an application has become void under §C of this regulation, the applicant shall:</text> <paragraph num="(1)"> <text>Submit a new application on the form required by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Meet all of the requirements for licensure established in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Pay the required fees under Regulation .18 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A license may not be issued until the Board has:</text> <paragraph num="(1)"> <text>Received and reviewed the CHRC; and</text> </paragraph> <paragraph num="(2)"> <text>Has approved the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Term and Renewal of License and Reinstatement of License."> <paragraph num="A."> <text>A license issued under this regulation authorizes the licensee to practice direct-entry midwifery while the license is active.</text> </paragraph> <paragraph num="B."> <text>A license:</text> <paragraph num="(1)"> <text>Expires on October 28 of every odd-numbered year;</text> </paragraph> <paragraph num="(2)"> <text>Is valid for 2 years, except for an initial license issued before the next renewal date;</text> </paragraph> <paragraph num="(3)"> <text>Issued for less than the full 2-year period shall be renewed at the next annual renewal date; and</text> </paragraph> <paragraph num="(4)"> <text>May be renewed for an additional term if the applicant:</text> <paragraph num="(a)"> <text>Meets the renewal requirements under §B(4)(c) of this regulation:</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Board a renewal fee specified in Regulation 18 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>Submits to the Board:</text> <paragraph num="(i)"> <text>A renewal application on the form that the Board requires; and</text> </paragraph> <paragraph num="(ii)"> <text>Satisfactory evidence of compliance with any continuing education or other competency requirements for license renewal.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to all other qualifications and requirements established by the Board for license renewal, the renewal applicant shall submit proof of completion of:</text> <paragraph num="(1)"> <text>20 accredited and Board-approved continuing education units to be completed in the 2 years preceding the renewal date;</text> </paragraph> <paragraph num="(2)"> <text>4 hours of peer review in the 2 years before the renewal date in accordance with NARM standards for official peer review; and</text> </paragraph> <paragraph num="(3)"> <text>Submission of the annual reports required under Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Board shall renew the license of each licensee who meets the requirements of this regulation.</text> </paragraph> <paragraph num="E."> <text>A renewal applicant shall be placed on inactive status if the licensee:</text> <paragraph num="(1)"> <text>Fails to provide satisfactory evidence of compliance with any continuing education requirements under this regulation for license renewal; or</text> </paragraph> <paragraph num="(2)"> <text>Fails to submit the annual report required under Regulation .12 of this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If the renewal applicant fails to submit the required documents within 1 year of the renewal date, the status of the license shall be changed to nonrenewed.</text> </paragraph> <paragraph num="G."> <text>The Board shall place a licensee on inactive status at the request of the licensee if the licensee submits to the Board:</text> <paragraph num="(1)"> <text>A completed application for inactive status on the form required by the Board; and</text> </paragraph> <paragraph num="(2)"> <text>The fee for inactive status specified in Regulation .18 of this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The Board shall reactivate the license of a licensee who has requested inactive status if the licensee:</text> <paragraph num="(1)"> <text>Complies with any continuing education and data reporting requirements established by the Board for this purpose;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board a reactivation fee specified in Regulation .18 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Is otherwise entitled to be licensed in accordance with this regulation.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The Board shall reinstate the license of an individual who has failed to renew the license for any reason if the individual:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed in accordance with this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Complies with any continuing education and data reporting requirements established by the Board for this purpose;</text> </paragraph> <paragraph num="(3)"> <text>Submits a completed application for reinstatement to the Board;</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Board the fee for reinstatement;</text> </paragraph> <paragraph num="(5)"> <text>Completes a criminal history record check in accordance with Heath Occupations Article, §8-303, Annotated Code of Maryland, for a license that has expired or lapsed for more than 1 year; and</text> </paragraph> <paragraph num="(6)"> <text>Applies to the Board for reinstatement of the license within 5 years after the license expires.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The Board may not reinstate the license of a licensed direct-entry midwife who fails to apply for reinstatement of the license within 5 years after the license expires. The individual may become licensed by meeting the current requirements for obtaining a new license as set forth in:</text> <paragraph num="(1)"> <text>Health Occupations Article, §§8-6C-13 — 8-6C-16, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>This chapter.</text> </paragraph> </paragraph> <paragraph num="K."> <text>A licensee shall submit to an additional criminal history records check every 12 years. The Board may not renew a license if the criminal history record information required by this section has not been received.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Fees."> <paragraph num="A."> <text>The fees listed in this regulation are not refundable.</text> </paragraph> <paragraph num="B."> <text>An initial license shall only be valid until the next renewal period.</text> </paragraph> <paragraph num="C."> <text>The fees are as follows:</text> <paragraph num="(1)"> <text>Initial application fee — $900;</text> </paragraph> <paragraph num="(2)"> <text>Biennial renewal — $800;</text> </paragraph> <paragraph num="(3)"> <text>Reactivation fee — $800;</text> </paragraph> <paragraph num="(4)"> <text>Reinstatement Fee — $900; and</text> </paragraph> <paragraph num="(5)"> <text>Inactive Status Fee — $100.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Prohibited Acts."> <paragraph num="A."> <text>Unless authorized to practice direct-entry midwifery, an individual may not represent to the public by title, description of service, method, procedure, or otherwise, that the individual is authorized to practice direct-entry midwifery in the State.</text> </paragraph> <paragraph num="B."> <text>A licensee may not advertise in a manner that is unreasonable, misleading, or fraudulent.</text> </paragraph> <paragraph num="C."> <text>Unless authorized to practice direct-entry midwifery, an individual may not use the abbreviation “LDEM” or use the designation “licensed direct-entry midwife”.</text> </paragraph> <paragraph num="D."> <text>Unless authorized to practice direct-entry midwifery or certified as a registered nurse midwife under Health Occupations Article, Title 8, Annotated Code of Maryland, an individual may not use the designation “midwife”.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§8-205 and Title 8, Subtitle 6C, Annotated Code of Maryland;Ch. 383, Acts of 2015</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 19, 2016 (43:25 Md. R. 1385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective July 11, 2023 (50:15 Md. R. 680); adopted permanently effective October 16, 2023 (50:20 Md. R. 887)</annotation> </annotations> </chapter> <chapter num="02" heading="Code of Ethics for Licensed Direct-Entry Midwives"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Abandonment” means:</text> <paragraph num="(a)"> <text>The unilateral termination of the licensed direct-entry midwife-client relationship by the direct-entry midwife without reasonable notice;</text> </paragraph> <paragraph num="(b)"> <text>Failure of the licensed direct-entry midwife to:</text> <paragraph num="(i)"> <text>Provide the client with a referral to an appropriate health care professional; or</text> </paragraph> <paragraph num="(ii)"> <text>Make reasonable arrangements with an appropriate and qualified healthcare professional to assume care for the client; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Leaving a client in the intrapartum period without properly terminating care and ensuring adequate care for the mother and unborn child.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Client” means:</text> <paragraph num="(a)"> <text>An individual for whom a licensed direct-entry midwife performs services; and</text> </paragraph> <paragraph num="(b)"> <text>The individual’s newborn for the purpose of perinatal or postpartum care.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Electronic devices” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephones with recording and picture-taking ability;</text> </paragraph> <paragraph num="(b)"> <text>Digital cameras or any other device that can record pictures and data;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machines, photocopiers, and scanners for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Recording devices.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Licensee” means a holder of a license issued by the Board to practice direct-entry midwifery in Maryland in accordance with Health Occupations Article, §8-6C-01, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Social media” means any form of electronic communication, including, but not limited to, communication by use of websites for social networking and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Responsibilities."> <paragraph num="A."> <text>A licensed direct-entry midwife shall:</text> <paragraph num="(1)"> <text>Provide services with respect for human dignity and the uniqueness of a client unrestricted by consideration of social or economic status, religious affiliation, personal attributes, or the nature of health problems;</text> </paragraph> <paragraph num="(2)"> <text>Safeguard a client's right to privacy by maintaining confidentiality of information;</text> </paragraph> <paragraph num="(3)"> <text>Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any individual;</text> </paragraph> <paragraph num="(4)"> <text>Promptly report a breach of confidentiality or privacy;</text> </paragraph> <paragraph num="(5)"> <text>Assume responsibility and accountability for one’s judgments and actions while providing direct-entry midwifery services;</text> </paragraph> <paragraph num="(6)"> <text>Maintain competence in direct-entry midwifery;</text> </paragraph> <paragraph num="(7)"> <text>Exercise informed judgment and use individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and delegating direct-entry midwifery activities to others;</text> </paragraph> <paragraph num="(8)"> <text>Inform the Board regarding unethical conduct by another licensed direct-entry midwife;</text> </paragraph> <paragraph num="(9)"> <text>Provide information about fees upon request by a client;</text> </paragraph> <paragraph num="(10)"> <text>Notify the Board in writing within 30 days if any license, certificate, permit, or registration granted by another state or territory for the practice of direct-entry midwifery or certified professional midwifery is restricted, suspended, revoked, or subjected to other disciplinary action by a licensing or certifying authority; and</text> </paragraph> <paragraph num="(11)"> <text>Make a client’s record available to the client upon request, complying with all applicable State and federal laws and regulations governing disclosure of medical records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed direct-entry midwife may not, when acting in the capacity or identity of a licensed direct-entry midwife:</text> <paragraph num="(1)"> <text>Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(3)"> <text>Perform new techniques and procedures without adequate education and practice;</text> </paragraph> <paragraph num="(4)"> <text>Assume duties and responsibilities in the practice of direct-entry midwifery without adequate preparation or without maintaining competency;</text> </paragraph> <paragraph num="(5)"> <text>Practice direct-entry midwifery if unfit to perform procedures or make decisions because of a physical or mental impairment including, but not limited to, a substance use disorder or the effects of prescription drugs;</text> </paragraph> <paragraph num="(6)"> <text>If engaged in research, coerce or pressure a subject to participate or continue to participate in the research;</text> </paragraph> <paragraph num="(7)"> <text>Knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record or billing record or other information about a client to conceal the information from use as evidence in an administrative, civil, or criminal proceeding; or</text> </paragraph> <paragraph num="(8)"> <text>Abandon a client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensed direct-entry midwife may not engage in behavior that dishonors the profession, whether or not acting in the capacity or identity of a licensed direct-entry midwife, including, but not limited to:</text> <paragraph num="(1)"> <text>Verbal abuse, including use of racial or ethnic slurs, directed toward a client, client 's family member, coworker, employer, Board staff member, or third party;</text> </paragraph> <paragraph num="(2)"> <text>Physically abusing, threatening, or intimidating a client, client’s family member, coworker, employer, Board staff member, or third party;</text> </paragraph> <paragraph num="(3)"> <text>Deceiving, defrauding, or stealing from a client, client’s family member, coworker, employer, or third party;</text> </paragraph> <paragraph num="(4)"> <text>Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication;</text> </paragraph> <paragraph num="(5)"> <text>Performing acts beyond the authorized scope of practice for which the individual is licensed;</text> </paragraph> <paragraph num="(6)"> <text>Obtaining or copying any part of a client’s health record for purposes other than:</text> <paragraph num="(a)"> <text>Providing health care to the client;</text> </paragraph> <paragraph num="(b)"> <text>Conducting quality improvement activities;</text> </paragraph> <paragraph num="(c)"> <text>Complying with legal requirements such as a subpoena; or</text> </paragraph> <paragraph num="(d)"> <text>Allowing a direct-entry midwifery student to use records for educational purposes if client identification has been redacted or disguised;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid medical indication;</text> </paragraph> <paragraph num="(8)"> <text>Reporting to work under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample;</text> </paragraph> <paragraph num="(9)"> <text>Reporting to work under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug;</text> </paragraph> <paragraph num="(10)"> <text>Using the power, influence, or knowledge inherent in or obtained during the direct-entry midwife-client relationship for the direct-entry midwife's personal gratification or benefit;</text> </paragraph> <paragraph num="(11)"> <text>Engaging in unprofessional or immoral conduct;</text> </paragraph> <paragraph num="(12)"> <text>Misrepresenting or concealing a material fact in obtaining a license, renewing a license, or reinstating a license; or</text> </paragraph> <paragraph num="(13)"> <text>Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed direct-entry midwife may not engage in sexual misconduct. Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client;</text> </paragraph> <paragraph num="(4)"> <text>Sexual advances toward, or the request of sexual favors from, a coworker, student, employer, client, or client's family member;</text> </paragraph> <paragraph num="(5)"> <text>Discussion of nontherapeutic sexual matters while treating a client;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs of a client for a sexual purpose;</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of a coworker, student, employer, client, or client's family member;</text> </paragraph> <paragraph num="(8)"> <text>Sexual contact with an incompetent or unconscious client;</text> </paragraph> <paragraph num="(9)"> <text>Intentionally exposing any of the direct-entry midwife's sexual body parts; and</text> </paragraph> <paragraph num="(10)"> <text>Intentionally exposing any of the client's sexual body parts for a nontherapeutic purpose.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Electronic devices, including but not limited to telephones, may not be used to record medical records or take pictures or videos of clients for purposes not directly related to client care without written client authorization.</text> </paragraph> <paragraph num="F."> <text>A licensed direct-entry midwife:</text> <paragraph num="(1)"> <text>May not make use of electronic devices and social media to transmit or place any client information online for public viewing without written client authorization; and</text> </paragraph> <paragraph num="(2)"> <text>Shall adhere to the following principles for the use of electronic devices and social media:</text> <paragraph num="(a)"> <text>Every licensed direct-entry midwife has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking;</text> </paragraph> <paragraph num="(b)"> <text>Licensed direct-entry midwives are bound to observe ethically prescribed direct-entry midwife-client boundaries online as in any other setting;</text> </paragraph> <paragraph num="(c)"> <text>Client information in electronic format shall be maintained in secured files;</text> </paragraph> <paragraph num="(d)"> <text>A licensed direct-entry midwife has an obligation to report any electronically generated material that could harm a client's privacy rights; and</text> </paragraph> <paragraph num="(e)"> <text>The standards of professionalism are the same when using electronic devices and social media as in any other circumstance.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of this chapter may result in the Board taking disciplinary action against a licensee pursuant to Health Occupations Article, §8-6C-20, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§8-205(a)(1) and (2) and 8-6C-12(a)(7), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: November 15, 2021 (48:23 Md. R. 981)</annotation> </annotations> </chapter> </subtitle> <subtitle num="65" heading="Board of Massage Therapy Examiners"> <chapter num="01" heading="General Regulations"> <regulation prefix="Regulation" num=".01" heading="Rules of Order."> <text>All proceedings of the Board in regular session shall be governed by Robert’s Rules of Order.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Board Officers, Members, and Staff."> <paragraph num="A."> <text>The Board shall, as the appointing authority, direct the operation of the staff through the executive director.</text> </paragraph> <paragraph num="B."> <text>Board members may not have monetary, pecuniary, or other interest in the affairs of any:</text> <paragraph num="(1)"> <text>Staff member; or</text> </paragraph> <paragraph num="(2)"> <text>Organization engaged in business with the Board, including:</text> <paragraph num="(a)"> <text>Businesses;</text> </paragraph> <paragraph num="(b)"> <text>Enterprises; or</text> </paragraph> <paragraph num="(c)"> <text>Other for-profit organizations.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A Board member or Board staff may not serve for compensation as an instructor in a continuing education course or program under Board cognizance over which that Board member or staff member serves in an approval capacity.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Scope."> <text>Except as specifically provided in this chapter, this chapter does not limit the right of an individual to:</text> <paragraph num="A."> <text>Practice a health occupation that the individual is otherwise authorized to practice under the Health Occupations Article, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="B."> <text>Advertise an occupation that the individual is otherwise authorized to practice under the Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the State Board of Massage Therapy Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Custodian of records” means an individual designated by the Board who:</text> <paragraph num="(a)"> <text>Is responsible for the security, storage, dissemination, and destruction of records; and</text> </paragraph> <paragraph num="(b)"> <text>Complies with:</text> <paragraph num="(i)"> <text>General Provisions Article, Title 4, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(ii)"> <text>Health Occupations Article, Title 6, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(iii)"> <text>This subtitle.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Health care setting” has the meaning stated in Health-Occupations Article,§6101(c), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“License” means the document issued by the Board to an individual qualified to practice massage therapy.</text> </paragraph> <paragraph num="(5)"> <text>“Licensed massage therapist (LMT)” means an individual who is licensed by the Board to practice massage therapy.</text> </paragraph> <paragraph num="(6)"> <text>“Licensee” means, unless the context requires otherwise, a licensed massage therapist or a registered massage practitioner authorized by the Board to practice massage therapy.</text> </paragraph> <paragraph num="(7)"> <text>Massage Therapy.</text> <paragraph num="(a)"> <text>“Massage therapy” means the use of manual techniques on soft tissues of the human body including stroking, kneading, tapping, stretching, compression, vibration, and friction.</text> </paragraph> <paragraph num="(b)"> <text>“Massage therapy” includes massage, myotherapy, and synonyms or derivatives of these terms, with or without the aid of:</text> <paragraph num="(i)"> <text>Cold packs;</text> </paragraph> <paragraph num="(ii)"> <text>Nonlegend topical applications; or</text> </paragraph> <paragraph num="(iii)"> <text>Heat limited to hot packs and heating pads.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Massage therapy” does not include the:</text> <paragraph num="(i)"> <text>Diagnosis of illness, disease, or injury;</text> </paragraph> <paragraph num="(ii)"> <text>Adjustment, manipulation, or mobilization of any of the articulations of the osseous structures of the body or spine; or</text> </paragraph> <paragraph num="(iii)"> <text>Laying on of hands, consisting of pressure or movement, with the exception of such techniques described in §B(7)(a) of this regulation on a fully clothed individual to specifically affect the electromagnetic energy or energetic field of the human body.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Massage therapy education program” means a course of study that prepares individuals in subjects related to the knowledge, techniques, skills, and abilities used in the practice of massage therapy.</text> </paragraph> <paragraph num="(9)"> <text>“Practice massage therapy” means to engage professionally and for compensation in massage therapy.</text> </paragraph> <paragraph num="(10)"> <text>“Registered massage practitioner (RMP) or registrant” means an individual who is registered by the Board to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> <paragraph num="(11)"> <text>“Registration” means, unless the context requires otherwise, a document issued by the Board to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> <paragraph num="(12)"> <text>“Research” means a curriculum component that systematically investigates and validates massage therapy techniques based on sources and data to provide successful outcomes for clients.</text> </paragraph> <paragraph num="(13)"> <text>“State Board of Massage Therapy Examiners Jurisprudence Examination” means the test developed by the Board to assess an applicant’s knowledge of the statute and regulations governing massage therapy in the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Licensure or Registration Required; Exceptions."> <text>An individual shall be licensed by the Board in order to practice massage therapy, and shall be registered by the Board in order to practice massage therapy in a setting that is not a health care setting, except for the following:</text> <paragraph num="A."> <text>A student enrolled in an approved education program as determined by the Board while performing massage therapy in the program;</text> </paragraph> <paragraph num="B."> <text>An individual who:</text> <paragraph num="(1)"> <text>Practices massage therapy in a recognized jurisdiction with an active license or registration in good standing;</text> </paragraph> <paragraph num="(2)"> <text>Is seeking to practice in Maryland exclusively with a visiting organization for not more than 7 consecutive days and not to exceed 30 days per calendar year; and</text> </paragraph> <paragraph num="(3)"> <text>Submits a timely request for approval to participate in an event by application at least 10 days prior to the event in accordance with Board procedures;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A family member performing massage therapy on another family member;</text> </paragraph> <paragraph num="D."> <text>An athletic trainer while functioning in the scope of the athletic trainer's professional capacity;</text> </paragraph> <paragraph num="E."> <text>An individual employed by the federal government to practice massage therapy while practicing within the scope of the individual's employment; or</text> </paragraph> <paragraph num="F."> <text>A licensed cosmetologist or esthetician who:</text> <paragraph num="(1)"> <text>Operates a beauty salon;</text> </paragraph> <paragraph num="(2)"> <text>Has obtained a permit from the State Board of Cosmetology as required under Business Occupations and Professions Article, §5-501, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Limits their practice to:</text> <paragraph num="(a)"> <text>Being within the scope of a license issued by the State Board of Cosmetology; and</text> </paragraph> <paragraph num="(b)"> <text>The application and removal of skin products, not including massage therapy.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Application for Licensure or Registration."> <paragraph num="A."> <text>An applicant for a license to practice massage therapy shall:</text> <paragraph num="(1)"> <text>Complete the application provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the application fee as specified in COMAR 10.65.07;</text> </paragraph> <paragraph num="(3)"> <text>Submit one recent 2 inch by 2 inch passport type photograph on a solid white background of the applicant;</text> </paragraph> <paragraph num="(4)"> <text>Submit a completed criminal background check;</text> </paragraph> <paragraph num="(5)"> <text>Provide evidence that the applicant is:</text> <paragraph num="(a)"> <text>Of good moral character; and</text> </paragraph> <paragraph num="(b)"> <text>18 years old or older;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Pass the State Board of Massage Therapy Examiners Jurisprudence Examination, which is administered by the Board, with a score of at least 75 percent;</text> </paragraph> <paragraph num="(7)"> <text>Have sent directly to the Board by the administering authority proof of having passed a Board-approved examination;</text> </paragraph> <paragraph num="(8)"> <text>Have copies of official transcripts sent directly to the Board by an institution of postsecondary education, as defined in Education Article, §10-101, Annotated Code of Maryland, and approved by the Maryland Higher Education Commission, from which the applicant graduated that documents completion of a program of at least 750 contact hours of massage therapy education in a curriculum that is:</text> <paragraph num="(a)"> <text>Approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Endorsed by:</text> <paragraph num="(i)"> <text>The Commission on Massage Therapy Accreditation (COMTA); or</text> </paragraph> <paragraph num="(ii)"> <text>An equivalent entity that accredits both institutions of postsecondary education and programs offering instruction in massage therapy; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Accredited by an institutional accreditation agency recognized by the United States Department of Education;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Provide documentation of having satisfactorily completed the requirements listed in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Provide documentation of current certification of qualification in CPR, at a minimum at the Basic Life Support (BLS) level; and</text> </paragraph> <paragraph num="(11)"> <text>Have verification of status sent directly to the Board by the issuing state, if certified, licensed, or registered to practice massage therapy in another state.</text> </paragraph> </paragraph> <paragraph num="B."> <text>On or before September 30, 2024, to be a registered massage practitioner, an applicant shall:</text> <paragraph num="(1)"> <text>Complete the application provided by the Board;</text> </paragraph> <paragraph num="(2)"> <text>Pay the application fee as specified in COMAR 10.65.07; and</text> </paragraph> <paragraph num="(3)"> <text>Submit one recent 2 inch by 2 inch passport type photograph on a solid white background of the applicant;</text> </paragraph> <paragraph num="(4)"> <text>Submit a completed criminal background check;</text> </paragraph> <paragraph num="(5)"> <text>Provide evidence that the applicant is:</text> <paragraph num="(a)"> <text>Of good moral character; and</text> </paragraph> <paragraph num="(b)"> <text>18 years old or older;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Pass the State Board of Massage Therapy Examiners Jurisprudence Examination, which is administered by the Board, with a score of at least 75 percent;</text> </paragraph> <paragraph num="(7)"> <text>Have sent directly to the Board by the administering authority proof of having passed a Board-approved examination;</text> </paragraph> <paragraph num="(8)"> <text>Have copies of official transcripts sent directly to the Board by the school from which the applicant graduated that documents completion of a program of at least 600 classroom hours in massage therapy education that is:</text> <paragraph num="(a)"> <text>Approved by the Board;</text> </paragraph> <paragraph num="(b)"> <text>Endorsed by:</text> <paragraph num="(i)"> <text>The Commission on Massage Therapy Accreditation (COMTA); or</text> </paragraph> <paragraph num="(ii)"> <text>An equivalent entity that accredits both institutions of postsecondary education and programs offering instruction in massage therapy; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Accredited by an institutional accreditation agency recognized by the United States Department of Education;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Provide documentation of having satisfactorily completed the requirements listed in Regulation .07 of this chapter;</text> </paragraph> <paragraph num="(10)"> <text>Provide documentation of current certification of qualification in CPR, at a minimum at the Basic Life Support (BLS) level; and</text> </paragraph> <paragraph num="(11)"> <text>Have verification of status sent directly to the Board by the issuing state, if certified, licensed, or registered to practice massage therapy in another state.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board may not issue a license or registration if the criminal history record information required under Health Occupations Article, §6-303(b), Annotated Code of Maryland, has not been received.</text> </paragraph> <paragraph num="D."> <text>On or after October 1, 2024, the Board may not issue an initial registration to practice as a registered massage practitioner.</text> </paragraph> <paragraph num="E."> <text>On or before October 31, 2026, on a request made on an application approved by the Board, the Board shall convert the registration of an individual registered by the Board as a registered massage practitioner to a license to practice massage therapy if the individual complies with regulations under this subtitle.</text> </paragraph> <paragraph num="F."> <text>Conversion.</text> <paragraph num="(1)"> <text>In order for an individual to convert from a registered massage practitioner to a licensed massage therapist, a minimum of one of the following shall be met by the conversion applicant:</text> <paragraph num="(a)"> <text>Has held a registration continuously in good standing for a minimum of 10 years preceding the conversion request;</text> </paragraph> <paragraph num="(b)"> <text>Attest to the accumulation of 1,000 hours of hands-on experience within the practice of massage therapy over the previous 2 years between:</text> <paragraph num="(i)"> <text>Work hours; and</text> </paragraph> <paragraph num="(ii)"> <text>Board-approved continuing education hours; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide documentation verifying a total of 750 hours of massage therapy education which may include:</text> <paragraph num="(i)"> <text>Contact hours from a Board-approved program of study of massage therapy; or</text> </paragraph> <paragraph num="(ii)"> <text>Board-approved continuing education hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>It is the burden of the conversion applicant to demonstrate that the applicant is eligible for conversion.</text> </paragraph> <paragraph num="(3)"> <text>The Board:</text> <paragraph num="(a)"> <text>May request additional documentation from the conversion applicant to substantiate or clarify the applicant’s conversion application; and</text> </paragraph> <paragraph num="(b)"> <text>May not convert the registration of an applicant whose registration has been suspended or revoked.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Required Massage Therapy Education and Training."> <paragraph num="A."> <text>Classroom Training: LMTs.</text> <paragraph num="(1)"> <text>An applicant for a license to practice massage therapy shall provide documentation of having graduated with at least 750 hours of education in a Board-approved program for the study of massage therapy that includes the following areas of content:</text> <paragraph num="(a)"> <text>100 hours in anatomy, physiology, and kinesiology;</text> </paragraph> <paragraph num="(b)"> <text>200 hours in massage therapy theory;</text> </paragraph> <paragraph num="(c)"> <text>50 hours in contraindications to massage therapy and pathology;</text> </paragraph> <paragraph num="(d)"> <text>30 hours in professional ethics;</text> </paragraph> <paragraph num="(e)"> <text>5 hours in health and hygiene;</text> </paragraph> <paragraph num="(f)"> <text>5 hours in research;</text> </paragraph> <paragraph num="(g)"> <text>175 hours in supervised hands-on techniques;</text> </paragraph> <paragraph num="(h)"> <text>50 hours in clinical assessment and documentation;</text> </paragraph> <paragraph num="(i)"> <text>35 hours in professional standards and business practices; and</text> </paragraph> <paragraph num="(j)"> <text>100 hours in supervised clinical experience/practicum.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cardiopulmonary resuscitation (CPR) shall be included but does not count towards the 750-hour minimum.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may attend more than one training institution, if the applicant graduates from a school requiring satisfactory completion of a minimum of 750 classroom hours in massage therapy education.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Classroom Training: RMPs.</text> <paragraph num="(1)"> <text>An applicant for a registration to practice massage therapy shall provide documentation of graduation from a Board-approved program of at least 600 hours for the study of massage therapy that includes the following areas of content:</text> <paragraph num="(a)"> <text>Anatomy, physiology, and kinesiology;</text> </paragraph> <paragraph num="(b)"> <text>Massage therapy theory;</text> </paragraph> <paragraph num="(c)"> <text>Contraindications and pathology;</text> </paragraph> <paragraph num="(d)"> <text>Professional ethics;</text> </paragraph> <paragraph num="(e)"> <text>Health and hygiene;</text> </paragraph> <paragraph num="(f)"> <text>Research;</text> </paragraph> <paragraph num="(g)"> <text>Supervised hands-on techniques; and</text> </paragraph> <paragraph num="(h)"> <text>Clinical assessment and documentation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Cardiopulmonary resuscitation (CPR) shall be included but does not count towards the 600-hour minimum.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may attend more than one training institution, if the applicant graduates from a school requiring satisfactory completion of a minimum of 600 classroom hours in massage therapy education.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Education and Training in a Foreign Country.</text> <paragraph num="(1)"> <text>The Board may grant a license or registration to practice massage therapy to an applicant who completed an educational program in a foreign country if the applicant:</text> <paragraph num="(a)"> <text>Can demonstrate through a Board-approved certifying agency that the applicant's education and training were substantially equivalent to the requirements of §A of this regulation through a Board-approved certifying agency; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the examination and other requirements of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board may interview an applicant under this section to determine whether the applicant's education and training meet the requirements of this chapter.</text> </paragraph> <paragraph num="(3)"> <text>An applicant shall arrange and pay for the professional translation into English of all documentation required under this chapter if the documentation is in a language other than English.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Licensure."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Issue a license to an approved applicant that:</text> <paragraph num="(a)"> <text>Is not valid for more than 2 years, and</text> </paragraph> <paragraph num="(b)"> <text>Expires on the date set by the Board; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notify an applicant not approved for licensure by letter which specifies the reason or reasons for disapproval.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee shall notify the Board of any change in the legal name or address of the licensee, in writing, within 60 days after the change occurs.</text> </paragraph> <paragraph num="C."> <text>The Board may not issue a license if the criminal history records information required under Health Occupations Article, §6–303(b), Annotated Code of Maryland, has not been received.</text> </paragraph> <paragraph num="D."> <text>Display of License. A licensee shall display the license and any current renewal license conspicuously in the space where the licensee is engaged in practice, including in any temporary space or in any exhibit location.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Registration."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Issue an initial registration until September 30, 2024, to an approved applicant that:</text> <paragraph num="(a)"> <text>Is not valid for more than 2 years; and</text> </paragraph> <paragraph num="(b)"> <text>Expires on the date set by the Board; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Notify an applicant not approved for registration, by a letter which specifies the reason or reasons for disapproval.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The registrant shall notify the Board, in writing, of any change in the legal name or address of the registrant within 60 days after the change occurs.</text> </paragraph> <paragraph num="C."> <text>The Board may not issue a registration if the criminal history records information required under Health Occupations Article, §3–302.1, Annotated Code of Maryland, has not been received.</text> </paragraph> <paragraph num="D."> <text>Display of Registration. A registrant shall display the registration and any current renewal registration conspicuously in the space where the registrant is engaged in practice, including in any temporary space or in any exhibit location.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Renewals."> <paragraph num="A."> <text>The Board shall send each licensee a renewal notice that states the:</text> <paragraph num="(1)"> <text>Date on which the current license or registration expires;</text> </paragraph> <paragraph num="(2)"> <text>Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license or registration to be issued before the current license or registration expires; and</text> </paragraph> <paragraph num="(3)"> <text>Amount of the renewal fee as specified in COMAR 10.65.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At least 30 days before the current license or registration expires, the Board shall send the renewal notice by electronic means or first-class mail to the last known electronic or physical address of the licensee.</text> </paragraph> <paragraph num="C."> <text>Late Renewal. A late fee in addition to a renewal fee shall be applied as specified in COMAR 10.65.07, if the request is received by the Board within 30 days of the expiration date of the license or registration.</text> </paragraph> <paragraph num="D."> <text>Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.65.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Reinstatement."> <paragraph num="A."> <text>The Board shall reinstate an individual whose license or registration has expired if the individual:</text> <paragraph num="(1)"> <text>Meets the renewal requirements of this chapter and Health Occupations Article, §6-306, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Pays the late and reinstatement fees as specified in COMAR 10.65.07, if the request is received by the Board more than 30 days after the expiration date of the license or registration; and</text> </paragraph> <paragraph num="(3)"> <text>Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.65.05.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed massage therapist who fails to apply for licensure reinstatement within 5 years after the expiration date of the license shall meet the requirements in effect at the time of the request in order to be licensed to practice massage therapy.</text> </paragraph> <paragraph num="C."> <text>Except as otherwise provided in this chapter, a registered massage practitioner who fails to apply for registration reinstatement within 5 years after the expiration date of the registration shall meet the requirements in effect at the time of the request in order to be registered to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Inactive Status."> <paragraph num="A."> <text>In accordance with Health Occupations Article, §6-306, Annotated Code of Maryland, a request by an active licensee or registrant to transfer a license or registration to inactive status shall be granted upon receipt of the:</text> <paragraph num="(1)"> <text>Completed Board-approved inactive status application; and</text> </paragraph> <paragraph num="(2)"> <text>Payment of the required, non-refundable, biennial inactive status fee set forth in COMAR 10.65.07.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual:</text> <paragraph num="(1)"> <text>May apply for inactive status only if the individual’s license or registration is still active at the time the inactive status application request is made;</text> </paragraph> <paragraph num="(2)"> <text>Shall renew and pay the biennial inactive status fee during each renewal period; and</text> </paragraph> <paragraph num="(3)"> <text>On inactive status is not authorized to and may not practice massage therapy.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Within 5 calendar years after being placed on inactive status, an individual seeking to be reactivated shall be required, as a condition of reactivation, to submit:</text> <paragraph num="(1)"> <text>Proof of having completed the required CEUs of which shall have been obtained within the 2-year period immediately preceding the application for reactivation; and</text> </paragraph> <paragraph num="(2)"> <text>Documentation of current CPR requirements at the designated level.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If an individual on inactive status seeks to be reactivated beyond the required 5-year period and conditions set forth under §C of this regulation, the individual shall be required to:</text> <paragraph num="(1)"> <text>Submit a new application;</text> </paragraph> <paragraph num="(2)"> <text>Pay the non-refundable fee set forth in COMAR 10.65.07;</text> </paragraph> <paragraph num="(3)"> <text>Submit to a criminal history records check in accordance with Health Occupations Article, §6-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(4)"> <text>Pass the Jurisprudence Examination required by the Board with a score of at least 75 percent; and</text> </paragraph> <paragraph num="(5)"> <text>Possess documentation of current certification of qualification in CPR, at a minimum at the Basic Life Support (BLS) level.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Duplicate Licenses and Registrations."> <paragraph num="A."> <text>The Board shall issue a duplicate license or registration to a licensee if:</text> <paragraph num="(1)"> <text>The licensee has a change of name, loses or damages the original, or practices in multiple locations; and</text> <paragraph num="(a)"> <text>Makes the request to the Board in writing;</text> </paragraph> <paragraph num="(b)"> <text>Provides appropriate legal documentation of the change;</text> </paragraph> <paragraph num="(c)"> <text>Pays the fee as specified in COMAR 10.65.07; and</text> </paragraph> <paragraph num="(d)"> <text>Surrenders the current license or registration;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Board, as a result of its error, issues an incorrect license or registration and the licensee:</text> <paragraph num="(a)"> <text>Notifies the Board in writing within 6 weeks of receipt of the incorrect license or registration; and</text> </paragraph> <paragraph num="(b)"> <text>Surrenders the incorrect license or registration; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The licensee does not receive the license or registration within 2 weeks of issuance and the licensee provides a notarized statement to the Board attesting to the non-receipt of the license or registration within 30 days of the date the license or registration was issued by the Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The requirements in §A of this regulation do not apply if the non-receipt was due to the licensee’s failure to change the licensee’s address of record with the Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Penalties."> <text>If a licensee fails to notify the Board of a change of name or address within the time required in Regulations .08B and .09B of this chapter, subject to the hearing provisions of Health Occupations Article, §6–309, Annotated Code of Maryland, the Board may impose an administrative penalty of $100.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Compelling Public Purpose Disclosure."> <paragraph num="A."> <text>The custodian of records for the Board may find that a compelling public purpose warrants disclosure of information in an application, certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="(1)"> <text>Possible criminal activity and the disclosure is to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="(2)"> <text>A possible violation of law and the disclosure is to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or</text> </paragraph> <paragraph num="(3)"> <text>Conduct by an individual that the Board reasonably believes may pose a risk to the public health, safety, or welfare, and the disclosure is to:</text> <paragraph num="(a)"> <text>A law enforcement authority;</text> </paragraph> <paragraph num="(b)"> <text>An administrative official;</text> </paragraph> <paragraph num="(c)"> <text>An Agency that regulates the individual; or</text> </paragraph> <paragraph num="(d)"> <text>A hospital or other health care facility where the individual has privileges.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Other Disclosures. This regulation does not prohibit or limit the ability of the custodian of records for the Board to disclose:</text> <paragraph num="(1)"> <text>General licensing information as provided in General Provisions Article, §4-333(c), Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>Any information that the Board may otherwise disclose by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Board Approval of Educational Programs."> <paragraph num="A."> <text>The Board may approve any program of studies provided by an accredited State educational institution for:</text> <paragraph num="(1)"> <text>Licensed massage therapists; and</text> </paragraph> <paragraph num="(2)"> <text>Registered massage practitioners.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Maintain a list of educational institutions in this State that currently provide an approved licensed massage therapist or registered massage practitioner program;</text> </paragraph> <paragraph num="(2)"> <text>Set standards for approval of programs licensing massage therapists or registered massage practitioners at educational institutions in this State; and</text> </paragraph> <paragraph num="(3)"> <text>Survey approved massage therapy programs and schools as necessary.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-333(c); Health Occupations Article, §§6-101, 6-102, 6-201—6-206, 6-301—6-306, and 6-504; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 adopted effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .05, and .07 recodified from COMAR 10.43.17 to be Regulations .03, .07, and .09 effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02—.04, .06, and .08—.10, amended and recodified from COMAR 10.43.17 to be Regulations .04—.06, .08, and .10—.12 effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1247); December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective August 18, 2025 (52:16 Md. R. 847)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective December 31, 2018 (45:26 Md. R. 1247)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11 and .12 recodified from COMAR 10.43.17 to be Regulations .13 and .14 effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 adopted effective April 9, 2018 (45:7 Md. R. 345)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 adopted effective December 31, 2018 (45:26 Md. R. 1247)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 repealed effective December 25, 2023 (50:25 Md. R. 1088)</annotation> </annotations> </chapter> <chapter num="02" heading="Rules of Procedure for Board Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to all contested case hearings before the Board of Massage Therapy Examiners or before the Office of Administrative Hearings. It does not apply to conferences or other informal investigations or proceedings.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Notice of Hearing."> <paragraph num="A."> <text>Written notice of a hearing shall be sent by the Board to all interested parties at least 30 days before the hearing. The notice shall state the date, time, and place of the hearing. It shall also state the issues or charges involved in the proceeding, provided, however, that if by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issues is necessary, they shall be fully stated as soon as practicable.</text> </paragraph> <paragraph num="B."> <text>Service upon a party shall be by delivery of the charging document and a copy of the complaint to the party in person. Instead of personal service, the Board may serve the charging document and a copy of the complaint by registered or certified mail, restricted delivery, return receipt requested.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Representation of Parties."> <text>Every party appearing at formal hearings has the right to appear in proper person, or by or with counsel.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Pre-hearing Procedures."> <paragraph num="A."> <text>Pre-hearing Conferences. The Board may set a pre-hearing conference as it deems appropriate.</text> </paragraph> <paragraph num="B."> <text>Oaths and Subpoenas. The Board may administer oaths and compel the attendance of witnesses and the production of physical evidence before it from witnesses upon whom process is served anywhere within the State as in civil cases in the circuit court of the county or of Baltimore City, by subpoena issued over the signature of the President or Secretary and the seal of the Board. Upon a request by a party and statement under oath that the testimony or evidence is necessary to their defense, the Board shall issue a subpoena on their behalf.</text> </paragraph> <paragraph num="C."> <text>All motions filed by a party with the Board or the Office of Administrative Hearings, as appropriate, shall be accompanied by a memorandum of points and authorities and shall be filed at least 15 days before the hearing. A copy shall be served on the opposing party. Any response shall be filed with the Board or the Office of Administrative Hearings, as appropriate, at least 7 days before the hearing and a copy shall be served on the opposing party.</text> </paragraph> <paragraph num="D."> <text>Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:</text> <paragraph num="(1)"> <text>A list of witnesses to be called;</text> </paragraph> <paragraph num="(2)"> <text>Copies of documents intended to be produced at the hearing; or</text> </paragraph> <paragraph num="(3)"> <text>Both §A(1) and (2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Mandatory Discovery.</text> <paragraph num="(1)"> <text>Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:</text> <paragraph num="(a)"> <text>The name and curriculum vitae of any expert witness who will testify at the hearing; and</text> </paragraph> <paragraph num="(b)"> <text>A detailed written report summarizing the expert’s testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony and any report of the expert.</text> </paragraph> <paragraph num="(3)"> <text>The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:</text> <paragraph num="(a)"> <text>At the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>Immediately before the scheduled hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If an expert adopts a sufficiently specific charging document as the expert’s report, that adoption satisfies the requirements set forth in this section.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Parties are not entitled to discovery of items other than as listed in §§D and E of this regulation.</text> </paragraph> <paragraph num="G."> <text>Both parties have a continuing duty to supplement their disclosures of witnesses and documents.</text> </paragraph> <paragraph num="H."> <text>Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:</text> <paragraph num="(1)"> <text>After the prehearing conference, if scheduled; or</text> </paragraph> <paragraph num="(2)"> <text>Later than 15 days before the hearing, if no prehearing conference is scheduled.</text> </paragraph> </paragraph> <paragraph num="I."> <text>The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.</text> </paragraph> <paragraph num="J."> <text>Construction.</text> <paragraph num="(1)"> <text>In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.</text> </paragraph> <paragraph num="(2)"> <text>In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Conduct of the Hearing."> <paragraph num="A."> <text>Duties of Presiding Officer.</text> <paragraph num="(1)"> <text>The Board shall conduct hearings before a quorum of the Board.</text> </paragraph> <paragraph num="(2)"> <text>For purposes of a hearing under this chapter, four Board members present and entitled to vote shall constitute a quorum.</text> </paragraph> <paragraph num="(3)"> <text>Board action shall be by majority vote of all the members then serving.</text> </paragraph> <paragraph num="(4)"> <text>The President, or the President’s designee, shall be the presiding officer, and shall have complete charge of the hearing, permit the examination of witnesses, admit evidence, rule on the admissibility of evidence, and adjourn or recess the hearing from time to time.</text> </paragraph> <paragraph num="(5)"> <text>The presiding officer may set reasonable time limits in arguments and presentation of evidence.</text> </paragraph> <paragraph num="(6)"> <text>The presiding officer shall be responsible for decorum in hearings and can suspend the proceedings as necessary to maintain decorum.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Legal Advisor and Counsel for the Board.</text> <paragraph num="(1)"> <text>The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the Board, and, upon such a request, this counsel has all the rights with regard to the:</text> <paragraph num="(a)"> <text>Submission of evidence, examination and cross-examination of witnesses;</text> </paragraph> <paragraph num="(b)"> <text>Presentation of summation and argument; and</text> </paragraph> <paragraph num="(c)"> <text>Filing of objections, exceptions, and motions as counsel for any party.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board as to questions of evidence and law.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Order of Procedure. The State shall present its case first. Then the respondent shall present his case. After this the State may present rebuttal.</text> </paragraph> <paragraph num="D."> <text>Examination of Witnesses and Introduction of Evidence.</text> <paragraph num="(1)"> <text>The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>Every party has the right on every genuine issue to:</text> <paragraph num="(a)"> <text>Call witnesses and present evidence;</text> </paragraph> <paragraph num="(b)"> <text>Cross-examine every witness called by the agency, or other party;</text> </paragraph> <paragraph num="(c)"> <text>Submit rebuttal evidence, present summation and argument; and</text> </paragraph> <paragraph num="(d)"> <text>File objections, exceptions, and motions, except that when a party is represented by counsel, all the submissions of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by this counsel.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The presiding officer, or the presiding officer’s designee, may examine:</text> <paragraph num="(a)"> <text>A witness called by a party; and</text> </paragraph> <paragraph num="(b)"> <text>An individual in attendance at the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A member of the Board may examine a witness called by a party.</text> </paragraph> <paragraph num="(5)"> <text>The Board may submit evidence from an investigative file to other administrative and criminal investigative offices to assist in the investigation and prosecution of a case.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records and Transcripts."> <paragraph num="A."> <text>The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding.</text> </paragraph> <paragraph num="B."> <text>If after a hearing, a licensee is found to have violated any of the provisions of Health Occupations Article, §6-308, Annotated Code of Maryland, the Board shall be entitled to reimbursement of costs by the licensee including any or all of the following items:</text> <paragraph num="(1)"> <text>Services rendered by court reporters;</text> </paragraph> <paragraph num="(2)"> <text>Transcription of the hearing record by court reporters;</text> </paragraph> <paragraph num="(3)"> <text>Expenses related to witnesses appearing for the State;</text> </paragraph> <paragraph num="(4)"> <text>Obtaining or reproducing documents, exhibits, or other evidentiary items;</text> </paragraph> <paragraph num="(5)"> <text>Hearing-related per diems and expenses for Board members; and</text> </paragraph> <paragraph num="(6)"> <text>Other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Decision and Order."> <paragraph num="A."> <text>Every decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law.</text> </paragraph> <paragraph num="B."> <text>A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or attorney of record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehearings."> <paragraph num="A."> <text>Any party aggrieved by the decision and order rendered may apply for rehearing within 10 days after service on him of the decision and order. Action on an application shall lie in the discretion of the Board.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise ordered, neither the rehearing nor the application for it shall stay the enforcement of the order, or excuse the person affected by it for failure to comply with its terms.</text> </paragraph> <paragraph num="C."> <text>The Board may consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Appeal."> <text>Any person whose license or registration has been revoked or suspended by the Board, or any person placed on probation or reprimand under the regulations in this chapter, may appeal the Board’s decision as provided by law.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§6-206, 6-309, and 6-310; State Government Article, §10-206; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to licensed massage therapists and registered massage practitioners.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Licensee” means an individual who is licensed by the Board to practice massage therapy.</text> </paragraph> <paragraph num="(2)"> <text>“Non bona fide treatment” means when a licensee or registrant treats or examines a client in a way that involves sexual contact, but there is no therapeutic reason for the procedure, or the procedure falls outside of reasonable massage therapy.</text> </paragraph> <paragraph num="(3)"> <text>“Registrant” means an individual who is registered by the Board to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> <paragraph num="(4)"> <text>“Sexually exploitative relationship” means when sexual contact occurs in an existing therapeutic relationship between the massage therapist and the client or between the instructor and the student, or within a period of time after formal termination of the therapeutic or instructor-student relationship where the client or student may still be vulnerable to the power imbalance that exists in the relationship between the licensee or registrant and the client or student, even if the relationship may appear to be mutually consensual.</text> </paragraph> <paragraph num="(5)"> <text>“Therapeutic deception” means when a licensee or registrant misrepresents sexual conduct as a legitimate form of treatment or instruction to a client or a student.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards of Practice."> <paragraph num="A."> <text>The licensee or registrant shall be concerned primarily with the welfare of the client.</text> </paragraph> <paragraph num="B."> <text>A licensee or registrant who suffers from a physical, mental, or emotional impairment, including chemical abuse, which impacts the licensee’s or registrant’s ability to practice massage therapy, shall proactively seek professional treatment and shall refrain from the practice of massage therapy until such time as the impairment no longer exists or reasonable accommodations can be made.</text> </paragraph> <paragraph num="C."> <text>A licensee or registrant shall:</text> <paragraph num="(1)"> <text>Use professional discretion and integrity in relationships with members of the public and health care community;</text> </paragraph> <paragraph num="(2)"> <text>Engage in professional conduct at all times, with honesty, integrity, self-respect, and fairness;</text> </paragraph> <paragraph num="(3)"> <text>Remain free from conflict of interest while fulfilling the objectives and maintaining the integrity of the massage therapy profession;</text> </paragraph> <paragraph num="(4)"> <text>Provide accurate fee information to the client, the individual responsible for payment for treatment, and the insurer;</text> </paragraph> <paragraph num="(5)"> <text>At all times respect the client's dignity, autonomy, and privacy;</text> </paragraph> <paragraph num="(6)"> <text>Practice massage therapy only as defined in the scope of practice set out in Health Occupations Article, §6-101, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(7)"> <text>Cooperate with a lawful investigation conducted by the Board of Massage Therapy Examiners, including:</text> <paragraph num="(a)"> <text>Furnishing information requested;</text> </paragraph> <paragraph num="(b)"> <text>Complying with a subpoena;</text> </paragraph> <paragraph num="(c)"> <text>Responding to a complaint at the request of the Board; and</text> </paragraph> <paragraph num="(d)"> <text>Providing meaningful and timely access to relevant client records;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Report to the Board of Massage Therapy Examiners, or other appropriate authority, conduct in the practice of massage therapy that indicates a violation of:</text> <paragraph num="(a)"> <text>This chapter;</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 6, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(c)"> <text>Any other law, including but not limited to aiding or abetting the unauthorized practice of massage therapy; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Attempt to correct others who misrepresent the licensee’s or registrant’s credentials, qualifications, education, or affiliations.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensee or registrant may not:</text> <paragraph num="(1)"> <text>Misrepresent professional credentials, qualifications, education, or affiliations;</text> </paragraph> <paragraph num="(2)"> <text>Knowingly engage in or condone behavior that:</text> <paragraph num="(a)"> <text>Is fraudulent;</text> </paragraph> <paragraph num="(b)"> <text>Is dishonest;</text> </paragraph> <paragraph num="(c)"> <text>Is deceitful; or</text> </paragraph> <paragraph num="(d)"> <text>Involves moral turpitude;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Engage in a commercial activity that conflicts with the duties of a licensee or registrant;</text> </paragraph> <paragraph num="(4)"> <text>Perform massage therapy on a client if a contraindication against this treatment exists;</text> </paragraph> <paragraph num="(5)"> <text>Discriminate against a client or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability; or</text> </paragraph> <paragraph num="(6)"> <text>Aid or abet any individual violating or attempting to violate any provision of law or regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Relationship with Client."> <paragraph num="A."> <text>A licensee or registrant shall:</text> <paragraph num="(1)"> <text>Use professional judgment in the use of evaluation and treatment procedure;</text> </paragraph> <paragraph num="(2)"> <text>Decline to administer treatment when the treatment is contraindicated or unjustified;</text> </paragraph> <paragraph num="(3)"> <text>Terminate a professional relationship with a client in an appropriate manner, such as:</text> <paragraph num="(a)"> <text>Providing the client with sufficient notice to permit the client to obtain the services of another professional; or</text> </paragraph> <paragraph num="(b)"> <text>Assisting the client by providing referrals, if appropriate.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Maintain legible, organized written records of treatment of any client under the care of the licensee or registrant for at least 5 years after termination of treatment and as provided by applicable provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(5)"> <text>Make the written records available to the client upon request, in compliance with applicable laws for disclosure of medical records;</text> </paragraph> <paragraph num="(6)"> <text>Make referrals only to other qualified and duly licensed or certified health care providers or practitioners, or both;</text> </paragraph> <paragraph num="(7)"> <text>Accurately inform clients, other health care professionals, and the public of the limitations of massage therapy;</text> </paragraph> <paragraph num="(8)"> <text>Adequately assess the client to determine if contraindications against massage therapy exist and refer the client to an appropriate health care practitioner; and</text> </paragraph> <paragraph num="(9)"> <text>Exercise independent professional judgment in the treatment or evaluation, or both, of clients, regardless of whether the client was referred by another health care provider.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee or registrant may not:</text> <paragraph num="(1)"> <text>Accept a client for treatment, or continue unnecessary treatment, when the client cannot be reasonably expected to benefit from the treatment;</text> </paragraph> <paragraph num="(2)"> <text>Receive remuneration from, or provide remuneration to, or split a fee with another health care provider or individual, or both, for either making or accepting a referral of the client to the health care provider or individual, or both;</text> </paragraph> <paragraph num="(3)"> <text>Make a guarantee or promise about the efficacy of a particular treatment, the licensee’s or registrant’s practice, or the results of a treatment unless supported by scientific principles accepted by the profession as determined by the governing board; or</text> </paragraph> <paragraph num="(4)"> <text>Exploit the professional relationship by:</text> <paragraph num="(a)"> <text>Continuing treatment unnecessarily; or</text> </paragraph> <paragraph num="(b)"> <text>Charging for a service:</text> <paragraph num="(i)"> <text>Not provided; or</text> </paragraph> <paragraph num="(ii)"> <text>Different from those actually provided.</text> </paragraph> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Professional Boundaries."> <paragraph num="A."> <text>A licensee or registrant shall:</text> <paragraph num="(1)"> <text>Maintain professional boundaries, even when the client, staff member, or student initiates crossing the professional boundaries of the professional relationship; and</text> </paragraph> <paragraph num="(2)"> <text>Respect and maintain professional boundaries and respect the client's, staff member’s, or student’s reasonable expectation of professional conduct.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensee or registrant may not:</text> <paragraph num="(1)"> <text>Exploit a relationship with a client, staff member, or student for the licensee’s or registrant’s personal advantage, including, but not limited to, a personal, sexual, romantic, or financial relationship;</text> </paragraph> <paragraph num="(2)"> <text>Engage in a sexually intimate act with a client; or</text> </paragraph> <paragraph num="(3)"> <text>Engage in sexual misconduct that includes, but is not limited to:</text> <paragraph num="(a)"> <text>Therapeutic deception;</text> </paragraph> <paragraph num="(b)"> <text>Non bona fide treatment; or</text> </paragraph> <paragraph num="(c)"> <text>A sexually exploitative relationship.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Records, Confidentiality, and Informed Consent."> <text>A licensee or registrant shall:</text> <paragraph num="A."> <text>Respect and maintain the privacy and confidentiality of the client;</text> </paragraph> <paragraph num="B."> <text>Disclose the client's record or information about the client only with the client's consent or as required by law;</text> </paragraph> <paragraph num="C."> <text>Adequately safeguard confidential client information, including storage and disposal of records;</text> </paragraph> <paragraph num="D."> <text>Provide sufficient information to a client to allow the client to make an informed decision regarding treatment, including:</text> <paragraph num="(1)"> <text>The purpose or nature of an evaluation or treatment regimen;</text> </paragraph> <paragraph num="(2)"> <text>Alternatives to treatment;</text> </paragraph> <paragraph num="(3)"> <text>Side effects and benefits of a proposed treatment regimen and the alternatives to that treatment;</text> </paragraph> <paragraph num="(4)"> <text>The estimated cost of treatment and alternatives to treatment;</text> </paragraph> <paragraph num="(5)"> <text>The right of the client to withdraw from treatment at any time, including the risks associated with withdrawing from treatment; and</text> </paragraph> <paragraph num="(6)"> <text>The client's right to decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Obtain the full informed consent of a client participating in a human research program, without a direct or implied penalty for the client's refusal to participate in the program, and with due regard for the client's autonomy and dignity;</text> </paragraph> <paragraph num="F."> <text>Comply with applicable federal and State laws for human research programs; and</text> </paragraph> <paragraph num="G."> <text>Comply with applicable provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Education and Training."> <paragraph num="A."> <text>A licensee or registrant shall:</text> <paragraph num="(1)"> <text>Recognize the licensee’s or registrant’s limitations and qualifications and practice massage therapy within the limits of these limitations and qualifications;</text> </paragraph> <paragraph num="(2)"> <text>Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and</text> </paragraph> <paragraph num="(3)"> <text>Maintain a current license or registration to practice massage therapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensee or registrant may not perform a treatment or provide a service which:</text> <paragraph num="(1)"> <text>The licensee or registrant is not qualified to perform; or</text> </paragraph> <paragraph num="(2)"> <text>Is beyond the scope of the licensee’s or registrant’s education, training, capabilities, experience, and scope of practice.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Ethical, Legal, and Professional Responsibilities of Massage Therapist and Practitioners."> <text>A licensee or registrant may not construe a failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and as generally recognized in the profession.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Penalties."> <text>If a licensee or registrant violates a regulation in this chapter, the Board may take action pursuant to Health Occupations Article, §6–308, Annotated Code of Maryland. The Board may also impose a penalty not exceeding $5,000.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-212, 6-102, 6-206, and 6-308, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.18 to COMAR 10.65.03 under new Subtitle, Board of Massage Therapy Examiners, Code of Ethics, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective January 2, 2017 (43:26 Md. R. 1446); August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="04" heading="Advertising"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs advertising by licensees or registrants of the Board of Massage Therapy Examiners in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advertising” means calling to the attention of the public the services one has to offer.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Massage Therapy Examiners.</text> </paragraph> <paragraph num="(3)"> <text>“Licensee” means an individual who is licensed by the Board to practice massage therapy.</text> </paragraph> <paragraph num="(4)"> <text>“Registrant” means an individual who is registered by the Board to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Advertising."> <paragraph num="A."> <text>A licensee or registrant may advertise massage services subject to the provisions of this chapter.</text> </paragraph> <paragraph num="B."> <text>The licensee or registrant shall state in the advertisement that the:</text> <paragraph num="(1)"> <text>Licensee is a “State of Maryland licensed massage therapist”; or</text> </paragraph> <paragraph num="(2)"> <text>Registrant is a “State of Maryland registered massage practitioner”.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An advertisement shall state at a minimum the:</text> <paragraph num="(1)"> <text>Licensee’s or registrant’s practice or business name;</text> </paragraph> <paragraph num="(2)"> <text>Licensee’s or registrant’s name;</text> </paragraph> <paragraph num="(3)"> <text>Licensee’s or registrant’s status as a licensee or registrant; and</text> </paragraph> <paragraph num="(4)"> <text>Practice or business address and telephone number.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An advertisement may not include statements that:</text> <paragraph num="(1)"> <text>Contain misrepresentations of facts;</text> </paragraph> <paragraph num="(2)"> <text>Misrepresent any professional qualifications, education, experience, or affiliation; or</text> </paragraph> <paragraph num="(3)"> <text>Make representations or implications that the licensee or registrant is willing to provide services that are illegal under the laws or regulations of Maryland or the United States.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual who is a registrant or a business entity that employs or contracts with registrants may not advertise that the individual or business entity provides health-related therapeutic massage services.</text> </paragraph> <paragraph num="F."> <text>An individual may not advertise that the individual practices massage therapy in Maryland if:</text> <paragraph num="(1)"> <text>The individual is otherwise qualified to practice massage therapy in any other state or country that has substantially similar requirements for authorization to practice massage therapy and the individual is in this State for not more than 7 days;</text> </paragraph> <paragraph num="(2)"> <text>The individual's application for a license or registration is pending before the Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An individual whose license or registration has been suspended or revoked by the Board may not advertise or initiate any advertising during the period of suspension or revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Solicitation."> <text>A licensee or registrant may not engage in solicitation, including, but not limited to, in-person, telephone, electronic, or direct mail solicitation, that:</text> <paragraph num="A."> <text>Amounts to fraud, undue influence, intimidation, or over reaching; or</text> </paragraph> <paragraph num="B."> <text>Contains statements which would be improper under Regulation .03C of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Accountability."> <text>A licensee or registrant shall be accountable under this chapter if the licensee or registrant uses an agent, partnership, professional association, health maintenance organization, or any other entity or means to implement actions prohibited by this chapter.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Penalties for Violation."> <text>A violation of this chapter may result in disciplinary action against the licensee or registrant under Health Occupations Article, Title 6, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§6-101, 6-102, 6-206, and 6-401, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.19 to COMAR 10.65.04 under new Subtitle, Board of Massage Therapy Examiners, Advertising, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective January 2, 2017 (43:26 Md. R. 1446); August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective January 2, 2017 (43:26 Md. R. 1446); August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 2, 2017 (43:26 Md. R. 1446); August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 2, 2017 (43:26 Md. R. 1446); August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuing Education Requirements"> <regulation prefix="Regulation" num=".01" heading="Required Continuing Education Hours."> <paragraph num="A."> <text>By October 31 of each renewal year, licensees and registrants shall satisfactorily complete a minimum of 24 continuing education hours within the previous 24 months as follows:</text> <paragraph num="(1)"> <text>3 hours in professional ethics or jurisprudence;</text> </paragraph> <paragraph num="(2)"> <text>3 hours in communicable disease education;</text> </paragraph> <paragraph num="(3)"> <text>16 hours in massage-related courses as approved by the Board; and</text> </paragraph> <paragraph num="(4)"> <text>2 hours in diversity, cultural competency, or implicit bias training.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, at the time of renewal, a licensee or registrant shall possess documentation of current certification of qualification in CPR at, a minimum, the Basic Life Support (BLS) level.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Approval of Continuing Education Programs."> <paragraph num="A."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Base approval of continuing education programs solely on content;</text> </paragraph> <paragraph num="(2)"> <text>Ensure that continuing education programs are directed toward improvement, advancement, and extension of professional skill and knowledge related to massage therapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A course or program offered by a pre-approved provider is approved without further review and is exempted from the requirements of Regulation .04 this chapter, provided that the course or program pertains to the human anatomy and includes any of the following topics:</text> <paragraph num="(1)"> <text>Massage practice modalities, application, scope, and philosophy;</text> </paragraph> <paragraph num="(2)"> <text>Contraindications;</text> </paragraph> <paragraph num="(3)"> <text>Massage therapy theory, technique, studies, and research;</text> </paragraph> <paragraph num="(4)"> <text>Professional ethics, jurisprudence, and risk management;</text> </paragraph> <paragraph num="(5)"> <text>Recordkeeping and professional business practices;</text> </paragraph> <paragraph num="(6)"> <text>Diversity, communications, and cultural competency; and</text> </paragraph> <paragraph num="(7)"> <text>Any other topic determined by the Board to meet the professional and educational requirements of the licensees and registrants.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Pre-approved Providers. Unless the requirement of §B of this regulation are not met or accreditation status of the pre-approved provider, including all sub-providers, schools, courses, and programs approved or sanctioned by the pre-approved provider unless otherwise prohibited, is not retained, the following shall be considered pre-approved providers:</text> <paragraph num="(1)"> <text>FSMTB;</text> </paragraph> <paragraph num="(2)"> <text>ABMP;</text> </paragraph> <paragraph num="(3)"> <text>NCBTMB;</text> </paragraph> <paragraph num="(4)"> <text>AOBTA;</text> </paragraph> <paragraph num="(5)"> <text>AMTA;</text> </paragraph> <paragraph num="(6)"> <text>National and State massage therapy organizations accredited by the federal or state government or a Board recognized accreditation society;</text> </paragraph> <paragraph num="(7)"> <text>Accredited state schools and U.S. Military Commands; and</text> </paragraph> <paragraph num="(8)"> <text>Such other Board-approved providers.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Up to 12 credit hours may be achieved for formal, authorized representation at a national, regional, or local convention or meeting relating to any of the above-cited organizations.</text> </paragraph> <paragraph num="E."> <text>Courses may be completed in live, home study, or online format.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Exemptions."> <paragraph num="A."> <text>Individuals issued initial licensure or registration within 12 months of the renewal date are exempt from the continuing education requirements in Regulation .01 of this chapter for the first renewal cycle.</text> </paragraph> <paragraph num="B."> <text>Licensees or registrants with documented hardships, and seeking an exemption, waiver, or extension from the continuing education requirements in Regulation .01 of this chapter, shall petition the Board in writing at least 90 days before the renewal date.</text> </paragraph> <paragraph num="C."> <text>The Board shall review the petition for an exemption, waiver, or extension and respond in writing to the licensee or registrant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Board Procedures."> <paragraph num="A."> <text>A program or institution seeking Board approval shall submit the following in writing at least 60 days before the starting date of the program or course:</text> <paragraph num="(1)"> <text>Title, location, and date of program or course;</text> </paragraph> <paragraph num="(2)"> <text>If electronically administered, website, database, or system used;</text> </paragraph> <paragraph num="(3)"> <text>Credit hours requested;</text> </paragraph> <paragraph num="(4)"> <text>Names and professional and educational qualifications of instructors;</text> </paragraph> <paragraph num="(5)"> <text>Name of attendance certifying officer and method of certification;</text> </paragraph> <paragraph num="(6)"> <text>Required texts or course books used;</text> </paragraph> <paragraph num="(7)"> <text>Program or course syllabus; and</text> </paragraph> <paragraph num="(8)"> <text>List of any sponsor of the program or course.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Board shall notify the requestor in writing of the Board's decision to approve or disapprove a program or course.</text> </paragraph> <paragraph num="C."> <text>The Board shall conduct a biennial audit of continuing education and shall notify audited licensees and registrants by mail or electronic means that the audited licensees and registrants shall produce satisfactory evidence of completion of the continuing education requirements.</text> </paragraph> <paragraph num="D."> <text>Licensees and registrants shall maintain accurate records, including continuing education course certifications, and if audited, shall present this documentation upon request to the Board.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §6-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.20 to COMAR 10.65.05 under new Subtitle, Board of Massage Therapy Examiners, Continuing Education Requirements, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C, D amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="06" heading="Record Keeping"> <regulation prefix="Regulation" num=".01" heading="General Requirements."> <paragraph num="A."> <text>The licensee or registrant shall maintain accurate, legible, and organized client records for every client, regardless of the procedure or modality employed.</text> </paragraph> <paragraph num="B."> <text>Sufficient information to be obtained and recorded shall include, at a minimum:</text> <paragraph num="(1)"> <text>Name, address, and other appropriate contact information;</text> </paragraph> <paragraph num="(2)"> <text>Summarized client history;</text> </paragraph> <paragraph num="(3)"> <text>Summarized reason for appointment or referral, including referral documentation, including forwarded reports and correspondence, if applicable;</text> </paragraph> <paragraph num="(4)"> <text>Billing and insurance documentation, if applicable; and</text> </paragraph> <paragraph num="(5)"> <text>Massage session summary in standard SOAP format, or its equivalent, which includes, at a minimum:</text> <paragraph num="(a)"> <text>Initial client assessment, including contraindications noted;</text> </paragraph> <paragraph num="(b)"> <text>Summarized therapy plan; and</text> </paragraph> <paragraph num="(c)"> <text>Progress notes, reflecting: summary of techniques used and response to techniques.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Maintenance and Release of Records."> <paragraph num="A."> <text>The licensee or registrant shall keep all client files secure and confidential in accordance with the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Client files are the property of the:</text> <paragraph num="(1)"> <text>Licensee or registrant when working as a sole proprietor or independent contractor; or</text> </paragraph> <paragraph num="(2)"> <text>Practice owner if the practitioner is an employee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Client files shall be released in a timely manner when authorized by the client in writing or compelled by law or regulation.</text> </paragraph> <paragraph num="D."> <text>The licensee or registrant may assess fees for duplicating client records for the patient or for another health care provider in accordance with Health-General Article, §4-403, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §6-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.43.21 to COMAR 10.65.06 under new Subtitle, Board of Massage Therapy Examiners, Record Keeping, effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="07" heading="Fees"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs licensees or those who are applying for licensure or registration by the Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees for Massage Therapy Licensure and Registration."> <text>The following fees are established by the Board and are non-refundable:</text> <paragraph num="A."> <text>Application fee . . . $150;</text> </paragraph> <paragraph num="B."> <text>License fee . . . $200;</text> </paragraph> <paragraph num="C."> <text>State examination fee . . . $275;</text> </paragraph> <paragraph num="D."> <text>Reexamination fee . . . $300;</text> </paragraph> <paragraph num="E."> <text>Biennial renewal fee . . . $250;</text> </paragraph> <paragraph num="F."> <text>Conversion to license fee. . .$100</text> </paragraph> <paragraph num="G."> <text>Late renewal fee (within 30 days of license or registration expiration, in addition to renewal fee) . . . $200;</text> </paragraph> <paragraph num="H."> <text>Reinstatement fee (after 31 days of expiration of license or registration, inclusive of a reinstatement fee, renewal fee, and late fee) . . . $475;</text> </paragraph> <paragraph num="I."> <text>Inactive renewal fee . . . $50;</text> </paragraph> <paragraph num="J."> <text>Reactivation fee (inclusive of a reactivation fee and renewal fee) . . . $350;</text> </paragraph> <paragraph num="K."> <text>Duplicate license or registration fee . . . $40;</text> </paragraph> <paragraph num="L."> <text>Duplicate license or registration ordered at renewal . . . $20;</text> </paragraph> <paragraph num="M."> <text>Verification fee . . . $50;</text> </paragraph> <paragraph num="N."> <text>Penalty for returned checks . . . $50;</text> </paragraph> <paragraph num="O."> <text>Mailing labels or rosters . . . $200;</text> </paragraph> <paragraph num="P."> <text>Penalty for failure to maintain correct name or address with the Board . . . $100;</text> </paragraph> <paragraph num="Q."> <text>Continuing Education Course processing fee per submission . . . $40;</text> </paragraph> <paragraph num="R."> <text>Paper copy of laws and regulations . . . $40.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Assessment for Health Care Professionals."> <paragraph num="A."> <text>Fees are nonrefundable with the exception of the examination fee.</text> </paragraph> <paragraph num="B."> <text>The examination fee may be refunded at the discretion of the Board if the applicant’s written request is received by registered mail at least 14 days before the examination.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§6-206 and 6-207, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01, .03, .04 adopted effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 recodified from COMAR 10.43.06.03 effective January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 25, 2023 (50:25 Md. R. 1088)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and Regulation .04 recodified to be Regulation .03 effective December 25, 2023 (50:25 Md. R. 1088)</annotation> </annotations> </chapter> <chapter num="08" heading="Licensure and Registration Examination — Special Needs Applicants"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes the procedures to be followed by examination applicants who have special needs because of a handicap or religious convictions.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Eligibility Requirements."> <paragraph num="A."> <text>An applicant with a disability may request modifications in examination materials or procedures by making a written request to the Board that includes:</text> <paragraph num="(1)"> <text>The applicant’s name;</text> </paragraph> <paragraph num="(2)"> <text>The date of the examination to be modified;</text> </paragraph> <paragraph num="(3)"> <text>A letter from the appropriate medical professional that:</text> <paragraph num="(a)"> <text>Confirms the disability; and</text> </paragraph> <paragraph num="(b)"> <text>Provides information describing the accommodations required; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A letter from the applicant’s education program, indicating what modifications, if any, were granted by the program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The applicant shall send the request for modification and supporting documentation to the Board by the application deadline.</text> </paragraph> <paragraph num="C."> <text>The Board reserves the right to review each special needs application and evaluate each on its individual merit.</text> </paragraph> <paragraph num="D."> <text>The applicant may be required to bear the cost of special arrangements or procedures to accommodate the applicant’s special needs.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§6-206 and 6-302, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 2017 (43:26 Md. R. 1446)</annotation> </annotations> </chapter> <chapter num="09" heading="Sanctioning Guidelines"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter shall be used by the Board and the Maryland Office of Administrative Hearings as a framework for imposing discipline.</text> </paragraph> <paragraph num="B."> <text>The Board and the Maryland Office of Administrative Hearings shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation.</text> </paragraph> <paragraph num="C."> <text>The Board is aware that there may be conduct by a licensee or registrant that does not fall squarely within a particular guideline contained in Regulation .06 of this chapter. In that event, the Board will use its best judgment to determine the appropriate sanction.</text> </paragraph> <paragraph num="D."> <text>The Board and the Maryland Office of Administrative Hearings shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees and registrants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Board” means the Maryland State Board of Massage Therapy Examiners.</text> </paragraph> <paragraph num="(2)"> <text>“Conditions” means requirements in a public or nonpublic order that a licensee or registrant is required to satisfy which include but are not limited to:</text> <paragraph num="(a)"> <text>Treatment and counseling for an emotional or physical illness;</text> </paragraph> <paragraph num="(b)"> <text>Submission to drug and alcohol testing;</text> </paragraph> <paragraph num="(c)"> <text>Abstinence from specified drugs;</text> </paragraph> <paragraph num="(d)"> <text>Abstinence from alcohol;</text> </paragraph> <paragraph num="(e)"> <text>Remedial training;</text> </paragraph> <paragraph num="(f)"> <text>Inspection;</text> </paragraph> <paragraph num="(g)"> <text>Monitoring;</text> </paragraph> <paragraph num="(h)"> <text>Evaluation;</text> </paragraph> <paragraph num="(i)"> <text>Supervision;</text> </paragraph> <paragraph num="(j)"> <text>Testing of clinical skills;</text> </paragraph> <paragraph num="(k)"> <text>Submission of written reports;</text> </paragraph> <paragraph num="(l)"> <text>A demonstration of knowledge or competency;</text> </paragraph> <paragraph num="(m)"> <text>Limitation of practice;</text> </paragraph> <paragraph num="(n)"> <text>Limitation on the administration of specified drugs to patients;</text> </paragraph> <paragraph num="(o)"> <text>The provision of pro bono massage therapy to the poor, elderly, or disabled;</text> </paragraph> <paragraph num="(p)"> <text>Obeyance of Maryland Massage Therapy Act, federal, State, and local laws; and</text> </paragraph> <paragraph num="(q)"> <text>The payment of a civil penalty.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Conduct” means behavior or action or a failure to behave or act that results in a violation of the Maryland Massage Therapy Act or the regulations adopted by the Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application."> <paragraph num="A."> <text>This chapter shall be used by the Board as a guide for sanctioning licensees and registrants in formal and informal actions and proceedings.</text> </paragraph> <paragraph num="B."> <text>Except as provided in Regulation .05 of this chapter, the Board shall impose a sanction not less severe than the minimum listed in Regulation .06 of this chapter, nor more severe than the maximum listed in Regulation .06 of this chapter.</text> </paragraph> <paragraph num="C."> <text>When conduct results in multiple violations of the Maryland Massage Therapy Act and the regulations adopted by the Board, the Board shall consider sanctions that are greater than those imposed for a single violation.</text> </paragraph> <paragraph num="D."> <text>This chapter does not apply to disciplinary matters reviewed by the Board that are initially closed.</text> </paragraph> <paragraph num="E."> <text>Unless otherwise indicated, the period of a suspension may be stayed in whole or in part.</text> </paragraph> <paragraph num="F."> <text>A respondent placed on suspension or probation shall have conditions attached to the suspension or probation which focus on the conduct and steps needed to assure public protection.</text> </paragraph> <paragraph num="G."> <text>Consent orders shall:</text> <paragraph num="(1)"> <text>Include an acknowledgement of the violation or violations; and</text> </paragraph> <paragraph num="(2)"> <text>Indicate that the respondent accepts personal responsibility for the respondent’s behavior.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the conduct is not described in Regulation .06 of this chapter, the Board shall use its judgment to determine appropriate sanctions.</text> </paragraph> <paragraph num="I."> <text>A departure from the sanctioning guidelines alone may not be grounds for any hearing or appeal of any Board action before the Board or the Maryland Office of Administrative Hearings.</text> </paragraph> <paragraph num="J."> <text>The sanctioning guidelines are not applicable to:</text> <paragraph num="(1)"> <text>Individuals seeking an initial license; or</text> </paragraph> <paragraph num="(2)"> <text>The summary suspension of a license under State Government Article, §10-226, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Notwithstanding the sanctioning guidelines, a respondent may surrender a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Aggravating and Mitigating Factors."> <paragraph num="A."> <text>Sanctions in a particular case may fall outside the range of the sanctioning guidelines established by the Board.</text> </paragraph> <paragraph num="B."> <text>Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of the sanctioning guidelines:</text> <paragraph num="(1)"> <text>Aggravating Factors:</text> <paragraph num="(a)"> <text>Previous criminal or administrative discipline history;</text> </paragraph> <paragraph num="(b)"> <text>Whether the offense was committed deliberately or with gross negligence or recklessness;</text> </paragraph> <paragraph num="(c)"> <text>Whether the offense has the potential for, or caused, serious patient harm;</text> </paragraph> <paragraph num="(d)"> <text>Whether the offense was part of a pattern of detrimental conduct;</text> </paragraph> <paragraph num="(e)"> <text>Whether the respondent pursued the respondent’s financial gain over the patient’s welfare;</text> </paragraph> <paragraph num="(f)"> <text>Whether the patient was especially vulnerable;</text> </paragraph> <paragraph num="(g)"> <text>Whether the respondent attempted to hide error or misconduct from patients or others;</text> </paragraph> <paragraph num="(h)"> <text>Whether the respondent:</text> <paragraph num="(i)"> <text>Concealed, falsified, or destroyed evidence; or</text> </paragraph> <paragraph num="(ii)"> <text>Presented false testimony or evidence;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Whether the respondent willfully and without legal justification failed to cooperate with a lawful investigation conducted by the Board; and</text> </paragraph> <paragraph num="(j)"> <text>Whether previous attempts to rehabilitate the respondent were unsuccessful; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Mitigating Factors:</text> <paragraph num="(a)"> <text>Absence of a prior disciplinary record;</text> </paragraph> <paragraph num="(b)"> <text>The passage of time since any prior offenses;</text> </paragraph> <paragraph num="(c)"> <text>Whether the respondent self-reported to the Board;</text> </paragraph> <paragraph num="(d)"> <text>Cooperation with the Board’s investigation;</text> </paragraph> <paragraph num="(e)"> <text>Full disclosure to the Board;</text> </paragraph> <paragraph num="(f)"> <text>Implementation of remedial measures to correct or mitigate harm arising from the misconduct;</text> </paragraph> <paragraph num="(g)"> <text>Timely good-faith efforts to make restitution or to rectify consequences of misconduct;</text> </paragraph> <paragraph num="(h)"> <text>Evidence of rehabilitation or rehabilitative potential;</text> </paragraph> <paragraph num="(i)"> <text>Absence of premeditation to commit the offense;</text> </paragraph> <paragraph num="(j)"> <text>Absence of potential harm to the public;</text> </paragraph> <paragraph num="(k)"> <text>Absence of adverse impact;</text> </paragraph> <paragraph num="(l)"> <text>Whether the offense was an isolated incident and not likely to recur;</text> </paragraph> <paragraph num="(m)"> <text>How and when the respondent has been involved in community service and the value of the community service to the community; and</text> </paragraph> <paragraph num="(n)"> <text>Voluntary admissions of misconduct.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Disciplinary Guidelines."> <text>The following guidelines shall be used by the Board as a guide for sanctioning a licensee or registrant in formal and informal actions and proceedings:</text> <paragraph num="A."> <text>Abuse — Physical and Emotional.</text> </paragraph> <paragraph num="B."> <text>Criminal Convictions or Plea of Nolo Contendere.</text> </paragraph> <paragraph num="C."> <text>Disciplined by Another Licensing or Disciplinary Authority.</text> </paragraph> <paragraph num="D."> <text>Diversion of Controlled Substances or Prescription Drugs.</text> </paragraph> <paragraph num="E."> <text>Failure to Renew a License When the Licensee or Registrant Has Continued to Practice.</text> </paragraph> <paragraph num="F."> <text>Noncompliance with Board Orders.</text> </paragraph> <paragraph num="G."> <text>Incompetent Practice or Misconduct.</text> </paragraph> <paragraph num="H."> <text>Sexual Misconduct.</text> </paragraph> <paragraph num="I."> <text>Substance Abuse.</text> </paragraph> <paragraph num="J."> <text>Unauthorized Practice.</text> </paragraph> <paragraph num="K."> <text>Unethical Conduct.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-606, 6-308, and 6-309, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 2, 2017 (43:26 Md. R. 1446)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective August 5, 2024 (51:15 Md. R. 710)</annotation> </annotations> </chapter> <chapter num="10" heading="Telehealth"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the practice of massage therapy using telehealth as an adjunct to, or replacement for, in-person client visits.</text> </paragraph> <paragraph num="B."> <text>Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Asynchronous” means not occurring in real time.</text> </paragraph> <paragraph num="(2)"> <text>“Board” means the Maryland Board of Massage Therapy Examiners.</text> </paragraph> <paragraph num="(3)"> <text>Health Care Services.</text> <paragraph num="(a)"> <text>“Health care services” means to provide client instruction through telehealth using:</text> <paragraph num="(i)"> <text>Techniques that include, but are not limited to, stretching, movement, breathing, and self-massage; and</text> </paragraph> <paragraph num="(ii)"> <text>Applications, such as nonlegend topicals and hot and cold packs or pads.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Health care services” does not include:</text> <paragraph num="(i)"> <text>Mental health counseling; or</text> </paragraph> <paragraph num="(ii)"> <text>Nutritional counseling.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“In-person” means within the physical presence of the client.</text> </paragraph> <paragraph num="(5)"> <text>“Synchronous” means occurring in real time.</text> </paragraph> <paragraph num="(6)"> <text>“Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Telehealth practitioner” means a Maryland licensed massage therapist or a registered massage practitioner performing telehealth services within their respective scope of practice as defined under Health Occupations Article, §6-101, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Licensure and Registration."> <text>Subject to the provisions of Health Occupations Article, Title 6, Annotated Code of Maryland, a telehealth practitioner shall be licensed or registered in Maryland when providing telehealth services to a client located in the State.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Standards of Practice for Telehealth."> <paragraph num="A."> <text>Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to:</text> <paragraph num="(1)"> <text>Verify the identification of the client receiving telehealth services through use of:</text> <paragraph num="(a)"> <text>A government-issued photograph identification;</text> </paragraph> <paragraph num="(b)"> <text>Documentation of the client’s:</text> <paragraph num="(i)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(ii)"> <text>Home address; or</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Except for registered massage therapists, an insurance, Medicaid, or Medicare card;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For an initial client-telehealth practitioner encounter, disclose the telehealth practitioner’s:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Maryland license or registration number; and</text> </paragraph> <paragraph num="(c)"> <text>Contact information;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Obtain oral or written consent from a client or client’s parent or guardian if State law requires the consent of a parent or guardian, including informing clients of the risks, benefits, and side effects of the recommended health care services;</text> </paragraph> <paragraph num="(4)"> <text>Securely collect and transmit a client’s medical health information, clinical data, clinical images, laboratory results, and self-reported medical health and clinical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means;</text> </paragraph> <paragraph num="(5)"> <text>Notify clients in the event of a data breach;</text> </paragraph> <paragraph num="(6)"> <text>Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and</text> </paragraph> <paragraph num="(7)"> <text>Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Except when providing asynchronous telehealth services, a telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Obtain or confirm an alternative method of contacting the client in case of a technological failure;</text> </paragraph> <paragraph num="(2)"> <text>Confirm whether the client is in Maryland and identify the specific practice setting in which the client is located; and</text> </paragraph> <paragraph num="(3)"> <text>Identify all individuals present at each location and confirm they are allowed to hear the client’s health information.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person massage therapy practice appointments.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Client Evaluation."> <paragraph num="A."> <text>A telehealth practitioner shall:</text> <paragraph num="(1)"> <text>Perform a synchronous or asynchronous clinical client evaluation that is appropriate for the client and the condition with which the client presents before providing health care services through telehealth; and</text> </paragraph> <paragraph num="(2)"> <text>If clinically appropriate for the client, provide or refer a client to:</text> <paragraph num="(a)"> <text>In-person treatment; or</text> </paragraph> <paragraph num="(b)"> <text>Another type of telehealth service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A telehealth practitioner may not treat a client based solely on an online questionnaire.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Telehealth Practitioner Discipline."> <paragraph num="A."> <text>The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a telehealth practitioner who practices telehealth as it would use for a licensee or registrant who does not use telehealth technology in the licensee’s or registrant’s practice.</text> </paragraph> <paragraph num="B."> <text>The failure of a telehealth practitioner to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§1-1001—1-1006 and 6-206, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 18, 2023 (50:18 Md. R. 799)</annotation> </annotations> </chapter> <chapter num="11" heading="Curriculum Approval"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Approval” means the status granted to a massage therapy education program that is in compliance with the regulations of the Board.</text> </paragraph> <paragraph num="(2)"> <text>“Board-recognized massage therapy accreditation agency (BRMTA)” means an institutional accreditation agency recognized by the United States Department of Education (USDOE).</text> </paragraph> <paragraph num="(3)"> <text>“Clinical faculty” means a clinical faculty member of a program who is licensed or registered to practice massage therapy in the State of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>Clinical Learning Experience.</text> <paragraph num="(a)"> <text>“Clinical learning experience” means faculty planned and guided learning activities designed to assist students to:</text> <paragraph num="(i)"> <text>Meet course objectives; and</text> </paragraph> <paragraph num="(ii)"> <text>Apply massage therapy knowledge and skills in the direct care of clients.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Clinical learning experience” includes:</text> <paragraph num="(i)"> <text>Direct care of clients within the relevant practice setting; and</text> </paragraph> <paragraph num="(ii)"> <text>Clinical support activities such as student clinics.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Conditional approval” means a limited-time status that:</text> <paragraph num="(a)"> <text>Is imposed by the Board if the Board finds evidence that the curriculum has failed to meet or maintain the regulations or requirements, or both, set by the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Allows the curriculum to continue to operate subject to the curriculum conforming to the Board’s requirements and recommendations within a time period set by the Board.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Controlling institution” means an organization that offers a massage therapy education curriculum.</text> </paragraph> <paragraph num="(7)"> <text>“Cooperating clinical entity” means an entity that provides the facilities and clinical resources for clinical learning experiences in massage therapy, with the massage therapy faculty or the clinical massage therapy faculty of the program responsible for the planning, implementation, and evaluation of these experiences.</text> </paragraph> <paragraph num="(8)"> <text>“Endorsement” means having a curriculum approved by:</text> <paragraph num="(a)"> <text>COMTA; or</text> </paragraph> <paragraph num="(b)"> <text>An equivalent entity that accredits both institutions of higher education and programs offering instruction in massage therapy.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Initial approval” means the approval period from the first admission of massage therapy students to the program through the first full implementation of the curriculum and graduation.</text> </paragraph> <paragraph num="(10)"> <text>“Licensed massage therapist” means an individual who is licensed by the Board to practice massage therapy.</text> </paragraph> <paragraph num="(11)"> <text>“Massage therapy faculty” means an individual who is employed to teach the practice of massage therapy full-time or part-time in a massage therapy education program.</text> </paragraph> <paragraph num="(12)"> <text>“MBLEx” means the Massage and Bodywork Licensing Examination, a national entry-level licensure exam, governed and administered by the Federation of State Massage Therapy Boards (FSMTB).</text> </paragraph> <paragraph num="(13)"> <text>“MHEC” means Maryland Higher Education Commission.</text> </paragraph> <paragraph num="(14)"> <text>Program.</text> <paragraph num="(a)"> <text>“Program” means a massage therapy educational program.</text> </paragraph> <paragraph num="(b)"> <text>“Program” includes:</text> <paragraph num="(i)"> <text>A college; or</text> </paragraph> <paragraph num="(ii)"> <text>A school.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(15)"> <text>“Regional massage therapy education accrediting agency” means an accrediting agency that operates in a specific geographic region of the United States and accredits post-secondary institutions and primary and secondary schools.</text> </paragraph> <paragraph num="(16)"> <text>“Registered massage practitioner” means an individual who is registered by the Board to practice massage therapy in a setting that is not a health care setting.</text> </paragraph> <paragraph num="(17)"> <text>“USDOE” means the United States Department of Education.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Approval of Curriculum Accredited by a Board-Recognized Massage Therapy Accreditation Agency."> <paragraph num="A."> <text>The Board shall approve any massage therapy education curriculum in Maryland whose program has been granted accreditation by a BRMTA, provided the curriculum meets all requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>A program that has been accredited by a BRMTA shall submit to the Board within 30 days of that accreditation:</text> <paragraph num="(1)"> <text>Evidence of current accreditation and endorsement status;</text> </paragraph> <paragraph num="(2)"> <text>Accreditation reports; and</text> </paragraph> <paragraph num="(3)"> <text>Any correspondence related to the status of the curriculum’s accreditation and endorsement.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Board shall continue to grant approval to curricula in Maryland provided that there is evidence of continuing accreditation by a BRMTA, and endorsement, and that those curricula continue to meet all requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>The Board shall be notified in writing within 10 business days of any change in accreditation or endorsement status by the massage therapy program.</text> </paragraph> <paragraph num="E."> <text>Withdrawal of accreditation or endorsement, accreditation or endorsement with warning, or failure to meet the requirements of this chapter or the standard for performance on the licensing examination shall be cause for Board review of the curriculum in accordance with Regulations .07B and C and .08 of this chapter.</text> </paragraph> <paragraph num="F."> <text>A curriculum on which the Board has taken action under Regulations .07B and C and .08 of this chapter shall be reported to MHEC.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Massage Therapy Faculty and Clinical Massage Therapy Faculty."> <paragraph num="A."> <text>Qualifications of Massage Therapy Faculty.</text> <paragraph num="(1)"> <text>Unless otherwise provided in this chapter, massage therapy faculty shall:</text> <paragraph num="(a)"> <text>Be currently licensed or registered to practice massage therapy in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Be academically and professionally qualified;</text> </paragraph> <paragraph num="(c)"> <text>Maintain expertise appropriate to their teaching responsibilities;</text> </paragraph> <paragraph num="(d)"> <text>Have a minimum of 5 years of clinical experience as a licensed massage therapist or registered massage practitioner; and</text> </paragraph> <paragraph num="(e)"> <text>Have an unencumbered license or registration for the past 5 years.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Non-massage therapy faculty or a licensed massage therapist or a registered massage practitioner not meeting the requirements for massage therapy faculty may teach selected portions of the curriculum that:</text> <paragraph num="(a)"> <text>Are unrelated to the practice of massage therapy; and</text> </paragraph> <paragraph num="(b)"> <text>Relate to their areas of expertise.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Waiver.</text> <paragraph num="(1)"> <text>A program experiencing a faculty shortage or a demonstrable difficulty in hiring appropriate faculty may petition the Board for a waiver of any provision of this regulation in massage therapy.</text> </paragraph> <paragraph num="(2)"> <text>The petition for a waiver of any requirement in massage therapy faculty qualification shall include documentation that the institution has made good faith attempts to hire massage therapy faculty.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Qualifications of Clinical Massage Therapy Faculty. Unless otherwise provided in this chapter, a clinical massage therapy faculty member shall:</text> <paragraph num="(1)"> <text>Be currently licensed or registered to practice massage therapy in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have a minimum of 5 years of clinical experience practicing massage therapy;</text> </paragraph> <paragraph num="(3)"> <text>Have the clinical experience necessary to function effectively and safely in the clinical massage therapy area of responsibility; and</text> </paragraph> <paragraph num="(4)"> <text>Have an unencumbered license or registration for the past 5 years.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Resources, Facilities, and Services."> <paragraph num="A."> <text>All facilities used for clinical learning experiences shall comply with all applicable federal, state, and local requirements.</text> </paragraph> <paragraph num="B."> <text>Cooperating clinical entities shall have:</text> <paragraph num="(1)"> <text>Clinical massage therapy faculty on-site and physically available for consultation with massage therapy student; and</text> </paragraph> <paragraph num="(2)"> <text>A dedicated student area for training demonstrations.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Students participating in clinical learning experiences shall be clearly identified as students.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Curriculum."> <paragraph num="A."> <text>The curriculum shall meet criteria as stated under COMAR 10.65.01.07.</text> </paragraph> <paragraph num="B."> <text>Changes in course offerings that will alter the curriculum, objectives, outcomes, competencies, or conceptual framework of the program shall:</text> <paragraph num="(1)"> <text>Be reported to the Board in the annual report; and</text> </paragraph> <paragraph num="(2)"> <text>Include the following information:</text> <paragraph num="(a)"> <text>The rationale for changes; and</text> </paragraph> <paragraph num="(b)"> <text>The methods of evaluation to be used to determine the effect of the change.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Clinical learning experiences shall be sufficient in quantity and quality to provide opportunities for students to achieve the stated objectives, outcomes, or competencies.</text> </paragraph> <paragraph num="D."> <text>Students shall have sufficient opportunities to develop the knowledge, skills, and abilities essential for a safe and effective massage therapy practice.</text> </paragraph> <paragraph num="E."> <text>Evaluation methods and tools used for measuring students’ knowledge, skills, and abilities shall be developed and implemented in order to ensure satisfactory progression of students.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Curriculum Evaluation."> <paragraph num="A."> <text>The program shall develop and implement a Board-approved evaluation plan for evaluating the total massage therapy education program not less than every 5 years for curricula that are accredited by a BRMTA.</text> </paragraph> <paragraph num="B."> <text>The evaluation plan shall include:</text> <paragraph num="(1)"> <text>All components of the curriculum;</text> </paragraph> <paragraph num="(2)"> <text>Evaluation time intervals;</text> </paragraph> <paragraph num="(3)"> <text>Student, graduate, faculty, cooperating clinical entities, and administration participation;</text> </paragraph> <paragraph num="(4)"> <text>Instruments or methods used; and</text> </paragraph> <paragraph num="(5)"> <text>Evidence that prior recommendations from the Board have been acted upon.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The evaluation process shall provide evidence that the program is meeting its objectives or outcomes as well as the changing needs of massage therapy and society.</text> </paragraph> <paragraph num="D."> <text>The outcome of evaluation includes:</text> <paragraph num="(1)"> <text>Recommendations for necessary curriculum revisions; and</text> </paragraph> <paragraph num="(2)"> <text>Direction for future action.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Annual Review."> <paragraph num="A."> <text>A program shall submit the following to the Board no later than July 1 of each year:</text> <paragraph num="(1)"> <text>An annual report detailing the program;</text> </paragraph> <paragraph num="(2)"> <text>A program catalog;</text> </paragraph> <paragraph num="(3)"> <text>Any annual reports to the BRMTA;</text> </paragraph> <paragraph num="(4)"> <text>Any correspondence related to the status of the program’s accreditation;</text> </paragraph> <paragraph num="(5)"> <text>A summary of practices followed in safeguarding the health and well-being of students;</text> </paragraph> <paragraph num="(6)"> <text>Accurate and complete data including, but not limited to, number of enrollments, admissions, graduates, and faculty; and</text> </paragraph> <paragraph num="(7)"> <text>A report detailing:</text> <paragraph num="(a)"> <text>Annual pass rates for first-time candidates who have taken the MBLEx exam; and</text> </paragraph> <paragraph num="(b)"> <text>Student retention and program completion rates.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Annually the Board shall:</text> <paragraph num="(1)"> <text>Review each program’s annual report, supporting documentation, and the licensure examination performance of first-time candidates from each program; and</text> </paragraph> <paragraph num="(2)"> <text>If necessary, conduct a survey or site visit, issue recommendations, place a program on conditional approval, or issue a formal notice of violation and withdraw approval in accordance with Regulation .08 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Approval may be reduced to conditional status for the following reasons:</text> <paragraph num="(1)"> <text>Noncompliance with this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Failure to hire faculty who meet the qualifications as stated in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Failure to submit records and reports to the Board in a timely manner;</text> </paragraph> <paragraph num="(4)"> <text>Failure to implement the approved curriculum;</text> </paragraph> <paragraph num="(5)"> <text>In accordance with §D of this regulation, failure to maintain the required passing rate on the licensing examination by first-time candidates;</text> </paragraph> <paragraph num="(6)"> <text>Failure to annually document that all faculty have current licenses; and</text> </paragraph> <paragraph num="(7)"> <text>Other activities or situations, as determined by the Board, that indicate a program is in jeopardy of violating statutory and regulatory requirements and standards.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Below Standard Performance on Licensure Examination.</text> <paragraph num="(1)"> <text>A program shall maintain a minimum pass rate of 65 percent for first-time candidates.</text> </paragraph> <paragraph num="(2)"> <text>The Board shall issue a warning to a program when the pass rate of first-time candidates is below 65 percent.</text> </paragraph> <paragraph num="(3)"> <text>For the first year a program does not meet the 65 percent pass rate requirements of §D(1) of this regulation and following the warning in §D(2) of this regulation, the program shall, within 30 calendar days, provide to the Board:</text> <paragraph num="(a)"> <text>A report that identifies the factors believed to have contributed to the below standard performance; and</text> </paragraph> <paragraph num="(b)"> <text>An action plan to be approved by the Board.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Second Successive Year Not in Compliance.</text> <paragraph num="(a)"> <text>For the second successive year that a program is not in compliance with §D(1) of this regulation, the program shall:</text> <paragraph num="(i)"> <text>Be placed on conditional approval; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide the Board with a report analyzing all aspects of the educational program and identifying areas that may be contributing to the below standard performance.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The Board’s professional staff may conduct a survey visit to the school and provide a report to the Board.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If compliance with the minimum licensure examination performance standard for first-time candidates is not made by the program within 1 examination year from the date of conditional approval, approval may be withdrawn.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Withdrawal of Curriculum Approval."> <paragraph num="A."> <text>At least 30 days before issuing a formal notice of violation of regulations to a program, the Board shall notify the chief administrator of:</text> <paragraph num="(1)"> <text>The controlling institution, if applicable; and</text> </paragraph> <paragraph num="(2)"> <text>The massage therapy education program that the Board is considering issuing a formal notice of violation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>During the 30-day period, the Board shall provide the chief administrator of the controlling institution, if applicable, and the massage therapy education program with an opportunity to meet with representatives of the Board to discuss the Board’s proposed action against the program.</text> </paragraph> <paragraph num="C."> <text>The program shall notify the Board within the 30-day period if it is interested in meeting with the Board. If the program requests a meeting, the Board shall make the arrangements.</text> </paragraph> <paragraph num="D."> <text>At the meeting, the program shall submit to the Board a plan with a proposed timeframe for correcting the violations.</text> </paragraph> <paragraph num="E."> <text>The Board shall:</text> <paragraph num="(1)"> <text>Evaluate the plan;</text> </paragraph> <paragraph num="(2)"> <text>Approve or modify the plan; and</text> </paragraph> <paragraph num="(3)"> <text>Have discretion to make changes to the timeframes for correcting violations or other components of the plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The program shall correct the violations within the timeframes approved by the Board.</text> </paragraph> <paragraph num="G."> <text>Approval may be withdrawn for the following reasons:</text> <paragraph num="(1)"> <text>Noncompliance with any of the regulations in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Failure to:</text> <paragraph num="(a)"> <text>Hire faculty who meet the qualifications as stated in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Submit records and reports to the Board in a timely manner;</text> </paragraph> <paragraph num="(c)"> <text>Implement the approved curriculum;</text> </paragraph> <paragraph num="(d)"> <text>Comply with the Board’s requirements within the specified timeframes;</text> </paragraph> <paragraph num="(e)"> <text>Maintain the required passing rate on the MBLEx exam by first-time candidates; and</text> </paragraph> <paragraph num="(f)"> <text>Annually document that all faculty have current licenses; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Other activities or situations, as determined by the Board, that indicate a program is not meeting statutory and regulatory requirements and standards.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Withdrawal of Approval. If the program does not correct the violations within the approved timeframes, the Board shall begin proceedings to remove the program from its list of institutions that offer approved massage therapy education programs in Maryland pursuant to Health Occupations Article, §§6-308—6-310, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="New Programs and Continuing Approval Requirements."> <paragraph num="A."> <text>New Program Requirements. The Board shall cooperate with MHEC when approving and reviewing curricula.</text> </paragraph> <paragraph num="B."> <text>Approval.</text> <paragraph num="(1)"> <text>Upon review of an application for curriculum approval, the Board may:</text> <paragraph num="(a)"> <text>Grant approval;</text> </paragraph> <paragraph num="(b)"> <text>Place the curriculum on provisional approval;</text> </paragraph> <paragraph num="(c)"> <text>Request revisions of the curriculum to align with the Board’s statute and regulations; or</text> </paragraph> <paragraph num="(d)"> <text>Deny the application.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Approval:</text> <paragraph num="(a)"> <text>Is required before the admission of students; and</text> </paragraph> <paragraph num="(b)"> <text>Requires concurrence of the Maryland Higher Education Commission.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Provisional Approval. A program seeking accreditation or endorsement may be granted provisional approval to graduate students if the program submits:</text> <paragraph num="(1)"> <text>Proof of application status for accreditation or endorsement;</text> </paragraph> <paragraph num="(2)"> <text>An application for provisional curriculum approval; and</text> </paragraph> <paragraph num="(3)"> <text>Otherwise meets the requirements of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A program may not operate under provisional status for longer than 2 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Closure of Programs."> <paragraph num="A."> <text>Upon request, the Board shall provide consultation concerning closing of a program.</text> </paragraph> <paragraph num="B."> <text>Upon the decision by a program to close, and at least 90 days before closing, the program shall notify the Board of its intent, giving the following information:</text> <paragraph num="(1)"> <text>Date and reason for closing;</text> </paragraph> <paragraph num="(2)"> <text>Plans for phasing out the program, including a teach-out program;</text> </paragraph> <paragraph num="(3)"> <text>Disposition of the records of students, graduates, and faculty; and</text> </paragraph> <paragraph num="(4)"> <text>Title of the position of the individual to be responsible for the records and the name of the agency in which the records will be located.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §6-302(b)(3)(i) and (c)(3)(i), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 25, 2023 (50:25 Md. R. 1088)</annotation> </annotations> </chapter> </subtitle> <subtitle num="66" heading="Office of the Inspector General"> <chapter num="01" heading="Civil Money Remedy"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter establishes standards for civil money remedies against any provider of health care services or health care supplies or equipment if the Office of the Inspector General finds there are grounds under Health General Article, §2-504.1, Annotated Code of Maryland, to impose a civil money remedy.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>The following terms have the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Civil money remedy” means a monetary remedy authorized by Health-General Article, §2-504.1, Annotated Code of Maryland, and imposed for a violation of statute or regulation governing the conditions of payment for any service or item for which the provider submitted a claim for payment and received payment.</text> </paragraph> <paragraph num="(2)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Hearing” means a contested case hearing as defined by the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(4)"> <text>“Identified recovery” means the total dollar amount of claims identified by the OIG as paid to the provider for a service or item not provided in accordance with applicable statute and regulations.</text> </paragraph> <paragraph num="(5)"> <text>"Inspector General” means the Inspector General, or the designated Assistant Inspector General, within the Department of Health and Mental Hygiene.</text> </paragraph> <paragraph num="(6)"> <text>“Office of Administrative Hearings (OAH)” means the independent unit in the Executive Branch of State government authorized to conduct hearings in contested cases, pursuant to the Administrative Procedure Act and this chapter.</text> </paragraph> <paragraph num="(7)"> <text>“OIG” means the Office of the Inspector General within the Department of Health and Mental Hygiene.</text> </paragraph> <paragraph num="(8)"> <text>“Violation” means the provision of a service that does not comply with applicable statutes or regulations or both.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Civil Money Remedy — Imposition."> <paragraph num="A."> <text>A civil money remedy may be imposed against a provider for violation of a State or federal law governing the conditions of payment for any service or item for which the provider submitted a claim for payment and received payment.</text> </paragraph> <paragraph num="B."> <text>It is within the sole discretion of the Inspector General as to whether a civil money remedy is imposed.</text> </paragraph> <paragraph num="C."> <text>A civil money remedy may not be imposed if otherwise prohibited by State or federal law.</text> </paragraph> <paragraph num="D."> <text>A civil money remedy imposed under this chapter:</text> <paragraph num="(1)"> <text>Is in lieu of full payment or full adjustment of the paid claim and not in addition to repayment of the claim;</text> </paragraph> <paragraph num="(2)"> <text>May not be less than the federal financial participation share of the identified improper claim amount unless good cause is shown;</text> </paragraph> <paragraph num="(3)"> <text>May not exceed the amount of reimbursement that the provider received for the paid claim;</text> </paragraph> <paragraph num="(4)"> <text>Is only available if the provider has not been subjected to a:</text> <paragraph num="(a)"> <text>Repayment penalty or fine;</text> </paragraph> <paragraph num="(b)"> <text>Criminal action; or</text> </paragraph> <paragraph num="(c)"> <text>Civil false claims action under either federal or State law for the same claim; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>May not be imposed if the claim was included in the universe of claims under an extrapolation calculation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A claim may be made on the basis of more than one violation, but there shall be only one civil money remedy per claim, regardless of the number of violations on which the claim is based.</text> </paragraph> <paragraph num="F."> <text>In determining whether a civil money remedy is to be imposed and in setting the amount of the civil money remedy, the Inspector General shall consider:</text> <paragraph num="(1)"> <text>The number, nature, and seriousness of the violation or violations;</text> </paragraph> <paragraph num="(2)"> <text>The provider’s history of compliance;</text> </paragraph> <paragraph num="(3)"> <text>The efforts made by the provider to correct the violations and any continuation of conduct after notification of possible violations;</text> </paragraph> <paragraph num="(4)"> <text>The provider’s level of cooperation with the Department or Inspector General as it relates to the review of the claim;</text> </paragraph> <paragraph num="(5)"> <text>The degree of risk to the health, life, or safety of consumers as a result of the violations; and</text> </paragraph> <paragraph num="(6)"> <text>Any other reasonable factors as fairness may require.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Inspector General shall give special consideration to the extent to which the provider’s size, operations, or financial condition:</text> <paragraph num="(1)"> <text>May have contributed to the violations; and</text> </paragraph> <paragraph num="(2)"> <text>May affect the provider’s ability to provide care and continue operations after payment of a civil money remedy.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the civil money remedy is imposed under this chapter, the Inspector General shall issue a written notice and order to the provider that:</text> <paragraph num="(1)"> <text>States the total amount of the civil money remedies being imposed; and</text> </paragraph> <paragraph num="(2)"> <text>Includes the following information:</text> <paragraph num="(a)"> <text>The basis on which the order is made;</text> </paragraph> <paragraph num="(b)"> <text>Each regulation or statute violated;</text> </paragraph> <paragraph num="(c)"> <text>The amount of each civil money remedy imposed for each claim;</text> </paragraph> <paragraph num="(d)"> <text>The number of claims and total value of the claims identified with errors;</text> </paragraph> <paragraph num="(e)"> <text>The manner in which the amount of the civil money remedy was calculated; and</text> </paragraph> <paragraph num="(f)"> <text>The provider’s appeal rights.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>The notice and order shall be sent to the provider by certified mail.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Civil Money Remedy — Appeal."> <paragraph num="A."> <text>A provider aggrieved by the imposition of a civil money remedy may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The Inspector General has the burden of proof with respect to the basis for the imposition of the civil money remedy.</text> </paragraph> <paragraph num="C."> <text>The Office of Administrative Hearings shall render a final decision within 30 days of the hearing.</text> </paragraph> <paragraph num="D."> <text>An order that imposes a civil money remedy is final when the provider has exhausted all opportunities to contest the civil money remedy in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>After exhaustion of all appeals, a provider shall pay a civil money remedy to the Department within 10 days after the provider receives a final order that affirms the imposition of the civil money remedy unless the Inspector General negotiates and approves a repayment schedule.</text> </paragraph> <paragraph num="F."> <text>If a provider does not pay the civil money remedy to the Department after receiving the final order or according to a negotiated repayment schedule, the State may deduct the amount of the civil money remedy from any sum that is then or later owed by the State to the provider, pursuant to State Finance and Procurement Article, §7-222, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §2-504.1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 17, 2017 (44:14 Md. R. 655)</annotation> </annotations> </chapter> </subtitle> <subtitle num="67" heading="Maryland Healthchoice Program"> <chapter num="01" heading="Maryland Medicaid Managed Care Program: Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>Except as expressly limited, in COMAR 10.67.01.12 the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“ACOG guidelines” means the American College of Obstetricians and Gynecologists' Guidelines for Perinatal Care that specify the recommended periodicity and content of prenatal, perinatal, and postpartum care, and are incorporated by reference in COMAR 10.67.04.01.</text> </paragraph> <paragraph num="(2)"> <text>“Acquired immune deficiency syndrome (AIDS)” has the meaning stated in COMAR 10.52.06.01B.</text> </paragraph> <paragraph num="(3)"> <text>“Action” means:</text> <paragraph num="(a)"> <text>Denial or limited authorization of a requested service, including:</text> <paragraph num="(i)"> <text>The type or level of service;</text> </paragraph> <paragraph num="(ii)"> <text>Requirements for medical necessity;</text> </paragraph> <paragraph num="(iii)"> <text>Appropriateness;</text> </paragraph> <paragraph num="(iv)"> <text>Setting; or</text> </paragraph> <paragraph num="(v)"> <text>Effectiveness of a covered benefit.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Reduction, suspension, or termination of a previously authorized service;</text> </paragraph> <paragraph num="(c)"> <text>Denial, in whole or part, of payment for a service, except for administrative denials of unclean claims;</text> </paragraph> <paragraph num="(d)"> <text>Failure to provide services in a timely manner;</text> </paragraph> <paragraph num="(e)"> <text>Failure of an MCO to act within the required time frames; or</text> </paragraph> <paragraph num="(f)"> <text>The denial of an enrollee's request to dispute a financial liability, including:</text> <paragraph num="(i)"> <text>Cost sharing;</text> </paragraph> <paragraph num="(ii)"> <text>Copayments;</text> </paragraph> <paragraph num="(iii)"> <text>Premiums;</text> </paragraph> <paragraph num="(iv)"> <text>Deductibles;</text> </paragraph> <paragraph num="(v)"> <text>Coinsurance; or</text> </paragraph> <paragraph num="(vi)"> <text>Other enrollee financial liabilities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Activities of daily living” means, in the context of COMAR 10.09.69, bathing, feeding, toileting, dressing, and ambulation;</text> </paragraph> <paragraph num="(5)"> <text>“Adjusted clinical group (ACG)” means a method for categorizing individuals into a case mix category based on the diagnoses assigned by their clinicians over a predetermined period of time.</text> </paragraph> <paragraph num="(6)"> <text>Administrative Services Organization.</text> <paragraph num="(a)"> <text>“Administrative services organization (ASO)” means an organization with which the Department contracts to assist in the management of behavioral health services.</text> </paragraph> <paragraph num="(b)"> <text>“Administrative services organization” does not mean an organization that directly provides health care services to waiver-eligible individuals.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Advanced practice nurse” means a nurse practitioner, nurse midwife, nurse anesthetist, or nurse psychotherapist who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, and COMAR 10.27.01</text> </paragraph> <paragraph num="(8)"> <text>“Aged” has the meaning stated in COMAR 10.09.24.02B.</text> </paragraph> <paragraph num="(9)"> <text>“AIDS payment category” means one of the two payment categories represented as individual rate cells within the rate table set forth in COMAR 10.67.04.19B(4)(b) to which enrollees with AIDS are assigned pursuant to COMAR 10.67.04.19B(2)(c)(ii).</text> </paragraph> <paragraph num="(10)"> <text>“Alcohol abuse” has the meaning stated in Health-General Article, §8-101(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Ancillary services” means diagnostic and somatic therapeutic services, including but not limited to radiology, laboratory services, cardiac diagnostics, neurology diagnostics, occupational therapy, physical therapy, durable medical equipment, disposable medical supplies, audiology, speech therapy, and cardiac rehabilitation therapy.</text> </paragraph> <paragraph num="(12)"> <text>“Annual quality assurance (QA) audit” means a systems performance review and a clinical care review.</text> </paragraph> <paragraph num="(13)"> <text>“Appeal” means a request for review of an action.</text> </paragraph> <paragraph num="(14)"> <text>“Applicant” means an entity that seeks approval from the Department to operate as a managed care organization in the Maryland Medicaid Managed Care Program.</text> </paragraph> <paragraph num="(15)"> <text>“Benefits package” means a set of health care services to which an MCO's enrollees are entitled, when the services are medically necessary, and which the MCO delivers to its enrollees either through providers with which it has employment or contractual relationships, or through reimbursement for services provided to the MCO's enrollees.</text> </paragraph> <paragraph num="(16)"> <text>“Blind” means having a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of no greater than 20 degrees.</text> </paragraph> <paragraph num="(17)"> <text>“Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed.</text> </paragraph> <paragraph num="(18)"> <text>“Caller abandonment rates” means the percentage of calls terminated by callers without speaking to a live operator.</text> </paragraph> <paragraph num="(19)"> <text>“Caller average hold time” means an average amount of time a call is on hold after being answered.</text> </paragraph> <paragraph num="(20)"> <text>“Caller service level” means the speed of answering the telephone.</text> </paragraph> <paragraph num="(21)"> <text>“Capitation payment” means the sum of money paid in advance on a monthly per capita basis by the Department for a fixed benefit package.</text> </paragraph> <paragraph num="(22)"> <text>“CARF” means the Commission on Accreditation of Rehabilitation Facilities (also known as the Rehabilitation Accreditation Commission), which is an organization that:</text> <paragraph num="(a)"> <text>Establishes quality standards for rehabilitative services; and</text> </paragraph> <paragraph num="(b)"> <text>Determines, in the context of its accreditation process, the extent to which rehabilitative service providers are in compliance with CARF quality standards.</text> </paragraph> </paragraph> <paragraph num="(23)"> <text>“Case management” means, assessing, planning, coordinating, monitoring, and arranging the delivery of medically necessary health-related services.</text> </paragraph> <paragraph num="(24)"> <text>“Case management contractor” means, in the context of COMAR 10.09.69, the Department's designee, or a subcontractor of the designee, which provides case management to participants assigned to it by the Department.</text> </paragraph> <paragraph num="(25)"> <text>“Case manager” means, in the context of COMAR 10.09.69, the individual who:</text> <paragraph num="(a)"> <text>Is employed by the Department's designee or a case management contractor;</text> </paragraph> <paragraph num="(b)"> <text>Is assigned by a case management contractor to manage the care of some or all of the participants assigned to that case management contractor;</text> </paragraph> <paragraph num="(c)"> <text>Participates in the meetings of the interdisciplinary team;</text> </paragraph> <paragraph num="(d)"> <text>Is responsible for the development of an individual's case management plan by the interdisciplinary team;</text> </paragraph> <paragraph num="(e)"> <text>Is responsible for implementing the participant's case management plan; and</text> </paragraph> <paragraph num="(f)"> <text>Is responsible for modifying the case management plan when information regarding a change in the participant's condition or status is received.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“CDS license” means the State licensure authorizing a health care practitioner to prescribe controlled dangerous substances.</text> </paragraph> <paragraph num="(27)"> <text>“Certified nursing assistant” means, in the context of COMAR 10.09.69, an individual:</text> <paragraph num="(a)"> <text>Certified as a nursing assistant by the Maryland Board of Nursing; and</text> </paragraph> <paragraph num="(b)"> <text>Who performs nursing tasks delegated by a registered nurse or licensed practical nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Child in State-supervised care” means a waiver-eligible child who is in the care and custody of a State agency pursuant to a court order or a voluntary placement agreement, including, but not limited to, waiver-eligible children:</text> <paragraph num="(a)"> <text>Under the supervision of the Department of Juvenile Services;</text> </paragraph> <paragraph num="(b)"> <text>In kinship or foster care under the Department of Human Services; and</text> </paragraph> <paragraph num="(c)"> <text>In residential treatment centers or psychiatric hospitals for the first 30 days after admission.</text> </paragraph> </paragraph> <paragraph num="(29)"> <text>“Child with a special health care need” means an individual younger than 21 years old, regardless of marital status, suffering from a moderate to severe chronic health condition:</text> <paragraph num="(a)"> <text>With significant potential or actual impact on health and ability to function;</text> </paragraph> <paragraph num="(b)"> <text>Which requires special health care services; and</text> </paragraph> <paragraph num="(c)"> <text>Which is expected to last longer than 6 months.</text> </paragraph> </paragraph> <paragraph num="(29-1)"> <text>“CHIP Health Services Initiative” means services offered to improve the health of low-income children pursuant to 5 U.S.C. §2105(a)(1)(D)(ii) of the Social Security Act.</text> </paragraph> <paragraph num="(30)"> <text>“Chronic hospital” has the meaning stated in COMAR 10.09.06.01B(4).</text> </paragraph> <paragraph num="(31)"> <text>“Clinical care review” means a review of the quality of clinical health care delivered by an MCO, which is:</text> <paragraph num="(a)"> <text>Required by federal law; and</text> </paragraph> <paragraph num="(b)"> <text>A component of an annual quality assurance (QA) audit.</text> </paragraph> </paragraph> <paragraph num="(32)"> <text>“CMS” means Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(33)"> <text>“Cold call marketing” means any unsolicited personal contact by the MCO with a potential enrollee for the purpose of marketing.</text> </paragraph> <paragraph num="(33-1)"> <text>“Collaborative Care Model” means the Psychiatric Collaborative Care Model, a patient-centered, evidence-based approach for integrating physical and behavioral health services in primary care settings that includes:</text> <paragraph num="(a)"> <text>Care coordination and management;</text> </paragraph> <paragraph num="(b)"> <text>Regular, systematic monitoring and treatment using a validated clinical rating scale;</text> </paragraph> <paragraph num="(c)"> <text>Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and</text> </paragraph> <paragraph num="(d)"> <text>Regular, systematic consultation for patients who do not show clinical improvement.</text> </paragraph> </paragraph> <paragraph num="(34)"> <text>“Commissioner” means the Maryland Insurance Commissioner of the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(35)"> <text>“Community-based substance abuse program” means a program that:</text> <paragraph num="(a)"> <text>Is certified by the Office of Health Care Quality (OHCQ); and</text> </paragraph> <paragraph num="(b)"> <text>Provides services in community settings not regulated by the Health Services Cost Review Commission.</text> </paragraph> </paragraph> <paragraph num="(36)"> <text>“Complaint” means an expression of dissatisfaction that results in either an appeal or a grievance.</text> </paragraph> <paragraph num="(37)"> <text>“Contract year” means the period of time to which the Maryland Medicaid Managed Care Program agreement between the Department and an MCO applies.</text> </paragraph> <paragraph num="(38)"> <text>“Core service agency (CSA)” means, in the context of COMAR 10.67.08, the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services.</text> </paragraph> <paragraph num="(39)"> <text>“Corporation” means:</text> <paragraph num="(a)"> <text>An entity formed under and meeting the requirements of Corporations and Associations Article, §2-101 et seq., Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>A foreign corporation registered with the Maryland Department of Assessments and Taxation.</text> </paragraph> </paragraph> <paragraph num="(40)"> <text>“County” means a county of this State and, unless expressly provided otherwise, Baltimore City.</text> </paragraph> <paragraph num="(40-1)"> <text>“Credibility adjustment” means an adjustment to the MLR for a partially credible MCO to account for a difference between the actual and target MLRs that may be due to random statistical variation.</text> </paragraph> <paragraph num="(41)"> <text>“Days” means, unless otherwise expressly indicated, calendar days.</text> </paragraph> <paragraph num="(42)"> <text>“DEA license” means the federal license authorizing a health care practitioner to prescribe controlled substances.</text> </paragraph> <paragraph num="(42-1)"> <text>“Definitive drug test” means drug screening tests that include:</text> <paragraph num="(a)"> <text>The ability to identify individual drugs and distinguish between structural isomers, but not necessarily stereoisomers, using:</text> <paragraph num="(i)"> <text>Gas chromatography or mass spectrometry; and</text> </paragraph> <paragraph num="(ii)"> <text>Liquid chromatography or mass spectrometry;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Qualitative or quantitative results;</text> </paragraph> <paragraph num="(c)"> <text>All source types for specimen selection;</text> </paragraph> <paragraph num="(d)"> <text>Specimen validity testing, per day, 122 or more drug classes including metabolites, if performed.</text> </paragraph> </paragraph> <paragraph num="(43)"> <text>“Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department.</text> </paragraph> <paragraph num="(44)"> <text>“Diagnostic evaluation services (DES)” has the meaning stated in COMAR 10.09.32.01B, and includes the services described in COMAR 10.09.32.04A.</text> </paragraph> <paragraph num="(45)"> <text>Direct Medical Education Costs (DME Costs).</text> <paragraph num="(a)"> <text>“Direct medical education costs (DME costs)” means costs associated with providing graduate medical education that are measurable using accounting data.</text> </paragraph> <paragraph num="(b)"> <text>“Direct medical education costs (DME costs)” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Salaries;</text> </paragraph> <paragraph num="(ii)"> <text>Supervision costs; and</text> </paragraph> <paragraph num="(iii)"> <text>Allocated overhead.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(46)"> <text>“Disabled” has the meaning stated in COMAR 10.09.24.02B.</text> </paragraph> <paragraph num="(47)"> <text>“Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq. (1981), and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services.</text> </paragraph> <paragraph num="(48)"> <text>“Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing the patient's health, or with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions; or</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="(49)"> <text>“Emergency services” means those health care services that are provided in a hospital emergency facility after the sudden onset of a medical condition that manifests itself by symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in:</text> <paragraph num="(a)"> <text>Placing the patient's health, or with respect to a pregnant woman, the health of the woman, or her unborn child, in serious jeopardy;</text> </paragraph> <paragraph num="(b)"> <text>Serious impairment to bodily functions; or</text> </paragraph> <paragraph num="(c)"> <text>Serious dysfunction of any bodily organ or part.</text> </paragraph> </paragraph> <paragraph num="(50)"> <text>“Encounter data” means information documenting a service to an enrollee.</text> </paragraph> <paragraph num="(51)"> <text>“Enrollee” has the meaning indicated in Health-General Article, §15-101(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(52)"> <text>“EPSDT-certified provider” means a physician or nurse practitioner who is certified by the Department's EPSDT program to provide comprehensive well-child services according to the Department's periodicity schedule and program standards to enrollees younger than 21 years old.</text> </paragraph> <paragraph num="(53)"> <text>“EPSDT comprehensive well-child services” means:</text> <paragraph num="(a)"> <text>All the screening services provided by an EPSDT-certified provider that are required or recommended on the EPSDT periodicity schedule; and</text> </paragraph> <paragraph num="(b)"> <text>Health care services to diagnose, treat, or refer problems or conditions discovered during the comprehensive well-child service.</text> </paragraph> </paragraph> <paragraph num="(54)"> <text>“EPSDT partial or interperiodic well-child service” means:</text> <paragraph num="(a)"> <text>A well-child service provided at times different than those outlined in the EPSDT periodicity schedule; or</text> </paragraph> <paragraph num="(b)"> <text>Any encounter by a health care practitioner necessary to diagnose or identify a condition and recommend a course of treatment.</text> </paragraph> </paragraph> <paragraph num="(55)"> <text>“EPSDT periodicity schedule” means the Departmentally approved list of required or recommended preventive health care services which are to be performed at specified ages.</text> </paragraph> <paragraph num="(56)"> <text>“Evaluations” means, in the context of COMAR 10.09.69, a determination of the health status of a patient in a patient's home or any other appropriate setting by a licensed professional for the purpose of designing an individual plan of care which incorporates the modalities of treatment which will promote optimal functional ability and recuperation.</text> </paragraph> <paragraph num="(57)"> <text>“External quality review organization (EQRO)” means a utilization and quality control peer review entity or a private review agent meeting the requirements of §1902(a)(30) of the Social Security Act, 42 U.S.C. §1396a(a)(30), which performs an independent external review of health care services furnished under a contract under §1903(m) of the Social Security Act, 42 U.S.C. §1396b.</text> </paragraph> <paragraph num="(58)"> <text>“Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health.</text> </paragraph> <paragraph num="(59)"> <text>“Federally qualified health center (FQHC)” means a clinic which either:</text> <paragraph num="(a)"> <text>Receives a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c;</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements for a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c; or</text> </paragraph> <paragraph num="(c)"> <text>Qualifies as a FQHC pursuant to a waiver from the Secretary of the U.S. Department of Health and Human Services of one or more of the requirements for receiving a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c.</text> </paragraph> </paragraph> <paragraph num="(60)"> <text>“Fiscal year (FY)” means the time period beginning the preceding July 1 and ending on June 30 of the referenced year.</text> </paragraph> <paragraph num="(61)"> <text>“Free-standing birth center” means a free-standing facility not associated with a hospital that provides nurse midwife services under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(61-1)"> <text>“Full credibility” means a standard for which the experience of an MCO is determined to be sufficient for the calculation of an MLR with a minimal chance that the difference between the actual and target MLR is not statistically significant.</text> </paragraph> <paragraph num="(62)"> <text>“Graduate medical education (GME)” means the training of physician interns and residents after completion of a medical degree program.</text> </paragraph> <paragraph num="(63)"> <text>“Graduate medical education costs (GME costs)” means the amount it costs a hospital to train physician interns and residents after their completion of a medical degree program, including both direct medical education costs and indirect medical education costs.</text> </paragraph> <paragraph num="(64)"> <text>“Grievance” means an expression of dissatisfaction about any matter other than an action, including but not limited to:</text> <paragraph num="(a)"> <text>The quality of care or services provided, and aspects of interpersonal relationships such as rudeness of a provider or employee;</text> </paragraph> <paragraph num="(b)"> <text>Failure to respect the enrollee's rights regardless of whether remedial action is requested; or</text> </paragraph> <paragraph num="(c)"> <text>A dispute over an extension of time proposed by the MCO to make an authorized decision.</text> </paragraph> </paragraph> <paragraph num="(65)"> <text>“HCQIS” means the Health Care Quality Improvement System produced by the Centers for Medicare and Medicaid Services.</text> </paragraph> <paragraph num="(66)"> <text>“Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(67)"> <text>“HealthChoice Financial Monitoring Report (HFMR)” means an annual financial report of an MCO's MMMCP-related activities during a specified calendar year that:</text> <paragraph num="(a)"> <text>Is submitted to the Department by an MCO pursuant to COMAR 10.67.04.15;</text> </paragraph> <paragraph num="(b)"> <text>Serves as a supplemental schedule to an MCO's quarterly and annual reports to the Maryland Insurance Administration; and</text> </paragraph> <paragraph num="(c)"> <text>Includes a completed HFMR form provided by the Department and any supplemental schedules required by the Department.</text> </paragraph> </paragraph> <paragraph num="(68)"> <text>“Health home” means a provider designated to offer enhanced care coordination and management services to individuals affected by, or at risk for, chronic conditions.</text> </paragraph> <paragraph num="(69)"> <text>“Health maintenance organization (HMO)” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(70)"> <text>Health Service Needs Information.</text> <paragraph num="(a)"> <text>“Health service needs information” means an instrument to identify new Maryland Medicaid Managed Care Program enrollees who require immediate or specialized health care services.</text> </paragraph> <paragraph num="(b)"> <text>“Health service needs information” does not mean an initial health screen performed by an MCO.</text> </paragraph> </paragraph> <paragraph num="(71)"> <text>“HEDIS” means the Healthcare Effectiveness Data Information Set, a set of indicators of managed care plan performance developed by the National Committee for Quality Assurance.</text> </paragraph> <paragraph num="(72)"> <text>“Hepatitis C” means having one of the following as a primary, secondary, tertiary, or level 4 diagnosis:</text> <paragraph num="(a)"> <text>070.41 — Acute or Unspecified Hepatitis C with hepatic coma;</text> </paragraph> <paragraph num="(b)"> <text>070.44 — Chronic Hepatitis C with hepatic coma;</text> </paragraph> <paragraph num="(c)"> <text>070.51 — Acute or unspecified Hepatitis C without mention of hepatic coma; or</text> </paragraph> <paragraph num="(d)"> <text>070.54 — Chronic Hepatitis C without mention of hepatic coma.</text> </paragraph> </paragraph> <paragraph num="(73)"> <text>“Hepatitis C plan risk factor” means an MCO-specific risk adjustment factor reflecting the level of risk associated with the proportion of the MCO's HIV/AIDS enrollees who also have Hepatitis C.</text> </paragraph> <paragraph num="(74)"> <text>“HIPAA” means the Health Insurance Portability and Accountability Act, a federal law enacted on August 21, 1996, whose purpose is to improve the efficiency and effectiveness of the health care system by standardizing the electronic exchange of administrative and financial data, provide security requirements for transmitted information, and protect the privacy of identifiable health information.</text> </paragraph> <paragraph num="(75)"> <text>“Historical diagnostic period” means the time period under consideration for the cumulative chronological determination of an enrollee's Hepatitis C status and ending:</text> <paragraph num="(a)"> <text>For the initial rate adjustment period, on June 30 of the calendar year before the rate year; or</text> </paragraph> <paragraph num="(b)"> <text>For the mid-year rate adjustment period, on December 31 of the calendar year before the rate year.</text> </paragraph> </paragraph> <paragraph num="(76)"> <text>“HIV” means infection with the human immunodeficiency virus.</text> </paragraph> <paragraph num="(77)"> <text>“HIV/AIDS” means:</text> <paragraph num="(a)"> <text>Infection with the human immunodeficiency virus; or</text> </paragraph> <paragraph num="(b)"> <text>Acquired immune deficiency syndrome.</text> </paragraph> </paragraph> <paragraph num="(78)"> <text>“HIV/AIDS enrollee” means an enrollee who is infected with HIV or has AIDS and is assigned to an HIV or AIDS payment category.</text> </paragraph> <paragraph num="(79)"> <text>“HIV payment category” means one of the four payment categories represented as individual rate cells within the rate tables set forth in COMAR 10.67.04.19B(4)(a) and (b), to which enrollees with HIV are assigned pursuant to COMAR 10.67.04.19B(1)(c)(ii) or (2)(c)(i).</text> </paragraph> <paragraph num="(80)"> <text>“Home”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53.</text> </paragraph> <paragraph num="(81)"> <text>“Home health agency” means, in the context of COMAR 10.09.69, an agency licensed by the Department in accordance with COMAR 10.07.10.</text> </paragraph> <paragraph num="(82)"> <text>“Home health aide” means, in the context of COMAR 10.09.69, an individual who meets all the conditions of participation specified in:</text> <paragraph num="(a)"> <text>42 CFR §484.36; and</text> </paragraph> <paragraph num="(b)"> <text>Health Occupations Article, Title 8, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(83)"> <text>“Homeless person” means an individual who, as defined by §340 of the Public Health Services Act, lacks housing, without regard to whether an individual is a member of a family, including an individual:</text> <paragraph num="(a)"> <text>Who is a resident in transitional housing; or</text> </paragraph> <paragraph num="(b)"> <text>Whose primary residence during the night is a supervised public or private facility that provides temporary living accommodations.</text> </paragraph> </paragraph> <paragraph num="(84)"> <text>“Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(85)"> <text>“HSCRC” means the Health Services Cost Review Commission, an independent agency functioning in the Department with the powers and duties set forth in Health-General Article, §19-201 et seq., Annotated Code of Maryland.</text> </paragraph> <paragraph num="(86)"> <text>“Indirect medical education costs (IME costs)” means costs associated with providing graduate medical education that, although not measurable using accounting data, are subject to assessment by application of a regression analysis methodology that:</text> <paragraph num="(a)"> <text>Estimates teaching hospitals' extra costs attributable to factors including, but not necessarily limited to the:</text> <paragraph num="(i)"> <text>Lower productivity of inexperienced residents, and</text> </paragraph> <paragraph num="(ii)"> <text>Adoption of advanced technology; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Controls, where possible, for confounding variables such as differences in:</text> <paragraph num="(i)"> <text>Area labor costs,</text> </paragraph> <paragraph num="(ii)"> <text>Uncompensated care, and</text> </paragraph> <paragraph num="(iii)"> <text>Case mix.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(87)"> <text>“Individualized education program (IEP)” means a written description of special education and related services developed by a multidisciplinary team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.09.</text> </paragraph> <paragraph num="(88)"> <text>“Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.02B.</text> </paragraph> <paragraph num="(89)"> <text>“Individual with a developmental disability” means an individual who, as defined in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq., has a physical or mental impairment arising before the age of 22, except for the sole diagnosis of mental disorder, that substantially limits one or more major life activities, and which may include, but is not limited to, an intellectual disability, specific learning disabilities, head injury, epilepsy, and muscular dystrophy.</text> </paragraph> <paragraph num="(90)"> <text>“Individual with a physical disability” means an individual who, as defined in P.L. 101-330, the Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq., has a physical impairment, either sensory or motor, that substantially limits one or more major life activities, and which may include, but is not limited to, orthopedic impairment, vision, speech, or hearing impairment, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, HIV/AIDS, and tuberculosis.</text> </paragraph> <paragraph num="(91)"> <text>“Initial health screen” means the comprehensive evaluation performed by the PCP, that includes a comprehensive history and physical examination to determine the new enrollee's baseline health status and health needs.</text> </paragraph> <paragraph num="(92)"> <text>“Initial rate adjustment period” has the meaning stated in COMAR 10.67.04.19-3A.</text> </paragraph> <paragraph num="(93)"> <text>“Inmate” means an individual who is serving time for a criminal offense and is confined involuntarily in State or federal prisons, jail, detention centers, or other penal facilities or who has been placed on home detention.</text> </paragraph> <paragraph num="(94)"> <text>Institution for Mental Disease.</text> <paragraph num="(a)"> <text>“Institution for mental disease (IMD)” means a hospital, nursing facility, or other institution of more than 16 beds that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases or substance abuse problems, including medical attention, nursing care, and related health care services.</text> </paragraph> <paragraph num="(b)"> <text>“Institution for mental disease (IMD)” includes the following categories of facilities, if the particular facility has more than 16 beds:</text> <paragraph num="(i)"> <text>Psychiatric hospitals;</text> </paragraph> <paragraph num="(ii)"> <text>Residential treatment centers;</text> </paragraph> <paragraph num="(iii)"> <text>In the context of admissions of enrollees who are 21 years old or older, intermediate care facilities-alcoholic (ICF-A) facilities; and</text> </paragraph> <paragraph num="(iv)"> <text>Residential drug-free treatment programs.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>“Institution for mental disease” does not include intermediate care facilities-alcoholic (ICF-A) facilities, except in the context of admission of enrollees who are 21 years old or older.</text> </paragraph> </paragraph> <paragraph num="(95)"> <text>“Interdisciplinary team” means, in the context of COMAR 10.09.69, the group convened and conducted by the case manager, consisting of the case manager and relevant service providers, that established the case management plan under the overall direction and coordination of the case manager and in consultation with the participant and, when applicable, the participant's family.</text> </paragraph> <paragraph num="(96)"> <text>“Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID)” means a residential facility providing care and services for individuals with an intellectual disability or developmental disabilities, or both.</text> </paragraph> <paragraph num="(96-1)"> <text>“Limited English proficiency” means the special need status of potential enrollees and enrollees who do not speak English as their primary language and who have a limited ability to read, write, speak, or understand English, and are therefore eligible to receive language assistance for a particular type of service, benefit, or encounter.</text> </paragraph> <paragraph num="(97)"> <text>“Local access area” means the local geographical area, as identified by the zip code groupings in COMAR 10.67.05.06D, that is located within the relevant MCOs service area and in which the relevant enrollee resides.</text> </paragraph> <paragraph num="(98)"> <text>“Local transportation grantee agency” means the county entity, usually the local health department, that receives transportation grant funds pursuant to COMAR 10.09.19.</text> </paragraph> <paragraph num="(99)"> <text>“Long-term care facility” means a chronic hospital, a chronic rehabilitation hospital, a nursing facility, or a special pediatric hospital.</text> </paragraph> <paragraph num="(100)"> <text>Long-Term Care Services.</text> <paragraph num="(a)"> <text>“Long-term care services” means the medical and support services required by an individual who, due to chronic illness or mental or physical disability, requires long-term care facility services over an extended period of time.</text> </paragraph> <paragraph num="(b)"> <text>“Long-term care services” includes services provided to a patient in a long-term care facility after the 30th day of continuous care following the enrollee's admission to the facility.</text> </paragraph> <paragraph num="(c)"> <text>“Long-term care services” do not include services provided to an enrollee admitted to a long-term care facility for a stay of less than 31 days of continuous care following the enrollee's admission to the facility.</text> </paragraph> </paragraph> <paragraph num="(101)"> <text>“Loss ratio” means the ratio of an MCO's:</text> <paragraph num="(a)"> <text>Net medical expenses plus medical management expenses which:</text> <paragraph num="(i)"> <text>Are quantified according to COMAR 10.67.04.19-4;</text> </paragraph> <paragraph num="(ii)"> <text>Relate solely to the MCO's MMMCP line of business; and</text> </paragraph> <paragraph num="(iii)"> <text>Are incurred during a specified period; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Net revenues which:</text> <paragraph num="(i)"> <text>Relate solely to the MCO's MMMCP line of business; and</text> </paragraph> <paragraph num="(ii)"> <text>Are earned during the same specified period in which the expenses referenced in §B(98)(a) of this regulation are incurred.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(102)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(103)"> <text>“Marketing” means any communication, from an MCO to a Medicaid recipient who is not enrolled in that MCO, that can reasonably be interpreted as intended to influence the recipient:</text> <paragraph num="(a)"> <text>To enroll in that particular MCO; or</text> </paragraph> <paragraph num="(b)"> <text>To not enroll in or to disenroll from another MCO.</text> </paragraph> </paragraph> <paragraph num="(104)"> <text>“Marketing materials” means materials that are produced in any medium, by or on behalf of an MCO, that can reasonably be interpreted as intended to market to potential enrollees.</text> </paragraph> <paragraph num="(105)"> <text>“Maryland Children's Health Program” means the State program for uninsured, low-income children with federal matching funds provided under Title XXI of the Social Security Act.</text> </paragraph> <paragraph num="(106)"> <text>“Maryland Medicaid Managed Care Program (MMMCP)” means the Medicaid reform program established in this subtitle, as authorized by Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, and by a §1115 waiver issued by the federal government.</text> </paragraph> <paragraph num="(107)"> <text>“Medicaid” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(108)"> <text>“Medical Assistance” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(109)"> <text>“Medical day care for adults” means a program of medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, due to their degrees of impairment, need health maintenance and restorative services supportive to their community living.</text> </paragraph> <paragraph num="(110)"> <text>“Medical day care for children” means a program of medically supervised health-related services provided in an ambulatory setting to children with complex medical needs who do not require 24-hour inpatient care, but, due to their specialized medical needs, cannot be managed in a typical day care setting.</text> </paragraph> <paragraph num="(111)"> <text>“Medical expense” means costs incurred by an MCO in connection with providing health care services to its enrollees.</text> </paragraph> <paragraph num="(111-1)"> <text>“Medical loss ratio (MLR)” means a formula that measures the ratio of MCO spending on medical and related benefits compared to revenue, to ensure MCOs are spending a sufficient amount of their premium revenue on medical expenses and other high-impact initiatives.</text> </paragraph> <paragraph num="(112)"> <text>“Medically necessary” means that the service or benefit is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with current accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, the consumer's family, or the provider.</text> </paragraph> </paragraph> <paragraph num="(113)"> <text>“Medically needy” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(114)"> <text>“Medical management expense” means costs incurred by an MCO in connection with outreach and utilization management activities as specified in COMAR 10.67.04.19-4.</text> </paragraph> <paragraph num="(115)"> <text>“Medical necessity” means what is medically necessary.</text> </paragraph> <paragraph num="(115-1)"> <text>“Medically underserved area” means an area designated by the Health Resources and Services Administration (HRSA) as having shortages of primary care, dental care, or mental health providers.</text> </paragraph> <paragraph num="(116)"> <text>“Medicare” means the federal program that provides benefits to the aged and disabled under Title XVIII of the Social Security Act.</text> </paragraph> <paragraph num="(117)"> <text>“MIA” means the Maryland Insurance Administration.</text> </paragraph> <paragraph num="(118)"> <text>“Mid-year rate adjustment period” has the meaning stated in COMAR 10.67.04.19-4A.</text> </paragraph> <paragraph num="(119)"> <text>“MIEMSS” means the Maryland Institute for Emergency Medical Service Systems.</text> </paragraph> <paragraph num="(119-1)"> <text>“MLR reporting year” means a period of 12 months consistent with the rating period selected by the Department.</text> </paragraph> <paragraph num="(120)"> <text>“Model Waiver Program” means the Home Care for Disabled Children under a Model Waiver as established in COMAR 10.09.27.</text> </paragraph> <paragraph num="(120-1)"> <text>“National Diabetes Prevention Program” means an evidence-based diabetes prevention program established by the Centers for Disease Control and Prevention.</text> </paragraph> <paragraph num="(121)"> <text>“Net medical expenses” means an MCO's total medical expenses less reinsurance recoveries.</text> </paragraph> <paragraph num="(122)"> <text>“Net revenues” means an MCO's total revenues less reinsurance premiums.</text> </paragraph> <paragraph num="(123)"> <text>“Network” has the same meaning as “provider panel”, as specified in this regulation.</text> </paragraph> <paragraph num="(123-1)"> <text>“Network provider” means a provider that is a member of the MCOs provider panel.</text> </paragraph> <paragraph num="(123-2)"> <text>“No credibility” means a standard for which the experience of an MCO is determined to be insufficient for the calculation of an MLR.</text> </paragraph> <paragraph num="(123-3)"> <text>“Non-claims costs” means expenses for administrative services other than:</text> <paragraph num="(a)"> <text>Incurred claims;</text> </paragraph> <paragraph num="(b)"> <text>Expenditures on activities that improve health care quality;</text> </paragraph> <paragraph num="(c)"> <text>Licensing and regulatory fees; or</text> </paragraph> <paragraph num="(d)"> <text>Federal and State taxes.</text> </paragraph> </paragraph> <paragraph num="(124)"> <text>“Nursing facility” has the meaning stated in COMAR 10.09.10.01B.</text> </paragraph> <paragraph num="(125)"> <text>Nutritional Counseling.</text> <paragraph num="(a)"> <text>“Nutritional counseling” means, in the context of COMAR 10.09.69, the review of the patient's nutritional status and advice on its improvement when medically necessary.</text> </paragraph> <paragraph num="(b)"> <text>“Nutritional counseling” includes family education provided by either a licensed dietitian or licensed nutritionist.</text> </paragraph> </paragraph> <paragraph num="(126)"> <text>“Nutritional supplements” means, in the context of COMAR 10.09.69, enteral feeding which is either the sole source of nutrition or a supplement which enhances the physical well-being of the patient and is medically indicated.</text> </paragraph> <paragraph num="(127)"> <text>“Ombudsman or ombudsman program” has the meaning stated in Health-General Article, §15-101(g), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(128)"> <text>“Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body.</text> </paragraph> <paragraph num="(129)"> <text>“Out-of-plan provider” means a provider that is neither the employee nor the subcontractor of the enrollee's assigned MCO.</text> </paragraph> <paragraph num="(130)"> <text>“Outreach services” means efforts to contact enrollees and bring them into care, as described in COMAR 10.67.05.03.</text> </paragraph> <paragraph num="(131)"> <text>“Overpayment” means:</text> <paragraph num="(a)"> <text>Any payment made by the Program to a provider in excess of the correct Program payment amount for a service; or</text> </paragraph> <paragraph num="(b)"> <text>Any payment for services under COMAR 10.67.06 made by the Program or an MCO which at the time of payment, or at a subsequent date, is determined to be inappropriate, inaccurate or in excess of the correct amount of the procedural code billed, for reasons including but not limited to:</text> <paragraph num="(i)"> <text>Improper claiming;</text> </paragraph> <paragraph num="(ii)"> <text>Lack of medical necessity;</text> </paragraph> <paragraph num="(iii)"> <text>Unacceptable practices;</text> </paragraph> <paragraph num="(iv)"> <text>Fraud, waste, or abuse; or</text> </paragraph> <paragraph num="(v)"> <text>Provider mistake.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(131-1)"> <text>“Partial credibility” means a standard for which the experience of an MCO is determined to be sufficient for the calculation of an MLR but with a non-negligible chance that the difference between the actual and target medical loss ratios is statistically significant.</text> </paragraph> <paragraph num="(132)"> <text>“Peer review organization” means an organization qualified by the Centers for Medicare and Medicaid Services in accordance with 42 CFR 462 that reviews health care practitioners, and the health care services they order or furnish, utilizing other practitioners from the same field of practice.</text> </paragraph> <paragraph num="(133)"> <text>“Personal care” has the meaning stated in COMAR 10.09.20.01B.</text> </paragraph> <paragraph num="(134)"> <text>“Plan of care” means, in the context of COMAR 10.09.69, the document which governs a participant's care management, and which:</text> <paragraph num="(a)"> <text>Includes the:</text> <paragraph num="(i)"> <text>Case management assessment report;</text> </paragraph> <paragraph num="(ii)"> <text>Interdisciplinary plan of care; and</text> </paragraph> <paragraph num="(iii)"> <text>Case management plan;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Is composed of the participant's health status and needs for medical, health-related, housing, and social services including, but not limited to:</text> <paragraph num="(i)"> <text>All pertinent diagnoses;</text> </paragraph> <paragraph num="(ii)"> <text>Functional status;</text> </paragraph> <paragraph num="(iii)"> <text>Type, frequency, and duration of services;</text> </paragraph> <paragraph num="(iv)"> <text>Treatment goals for each type of service;</text> </paragraph> <paragraph num="(v)"> <text>Medication;</text> </paragraph> <paragraph num="(vi)"> <text>Social support structure;</text> </paragraph> <paragraph num="(vii)"> <text>Current service providers;</text> </paragraph> <paragraph num="(viii)"> <text>Assigned level of care;</text> </paragraph> <paragraph num="(ix)"> <text>Diet;</text> </paragraph> <paragraph num="(x)"> <text>Current living arrangement; and</text> </paragraph> <paragraph num="(xi)"> <text>Emergency plan, if appropriate; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Is established in consultation with the interdisciplinary team.</text> </paragraph> </paragraph> <paragraph num="(135)"> <text>“Postpartum” means within 2 months after delivery of a child.</text> </paragraph> <paragraph num="(136)"> <text>“Poststabilization care services” means covered services, related to an emergency medical condition, that are provided after an enrollee is stabilized in order to maintain the stabilized condition, or under the circumstances described in 42 CFR §438.114(e), as amended, to improve or resolve the enrollee's condition.</text> </paragraph> <paragraph num="(137)"> <text>“Potential enrollee” means a Medicaid recipient who is determined eligible for the HealthChoice program but is not yet an enrollee of a specific MCO.</text> </paragraph> <paragraph num="(138)"> <text>“Practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or a state contiguous to Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program.</text> </paragraph> <paragraph num="(139)"> <text>“Preauthorization”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53.</text> </paragraph> <paragraph num="(140)"> <text>“Pregnant” means the period beginning with conception and ending at delivery.</text> </paragraph> <paragraph num="(140-1)"> <text>“Presumptive drug tests” means drug screening tests that include:</text> <paragraph num="(a)"> <text>Any number of drug classes;</text> </paragraph> <paragraph num="(b)"> <text>Any number of devices;</text> </paragraph> <paragraph num="(c)"> <text>Sample validation; and</text> </paragraph> <paragraph num="(d)"> <text>The use of:</text> <paragraph num="(i)"> <text>Direct optical observation;</text> </paragraph> <paragraph num="(ii)"> <text>Instrument assisted direct optical observation; or</text> </paragraph> <paragraph num="(iii)"> <text>Instrumented chemistry analyzers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(141)"> <text>“Primary care” means medical care that addresses a patient's general health needs, including the coordination of the patient's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the enrollee's health records, and referral for medically necessary specialty care.</text> </paragraph> <paragraph num="(142)"> <text>“Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the enrollee, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.67.06.</text> </paragraph> <paragraph num="(143)"> <text>“Primary care residency slots” means, in the context of COMAR 10.67.11, positions in a teaching hospital's residency program occupied after completion of a medical degree program by physicians who have trained in family medicine, internal medicine, pediatrics, or obstetrics and gynecology.</text> </paragraph> <paragraph num="(144)"> <text>“Primary mental health services” means the clinical evaluation and assessment of mental health services needed by an individual and the provision of services or referral for additional services as deemed medically necessary by a primary care provider.</text> </paragraph> <paragraph num="(145)"> <text>“Private duty nursing” means, in the context of COMAR 10.09.69, skilled nursing services for recipients who require more individual and continuous care than is available under the Medicaid State Plan, and which are provided by a registered nurse or a licensed practical nurse, in a recipient's own home or another setting when normal life activities take the recipient outside his or her home.</text> </paragraph> <paragraph num="(146)"> <text>“Program”, unless the context indicates otherwise, has the meaning stated in COMAR 10.09.36.01B.</text> </paragraph> <paragraph num="(147)"> <text>“Progress note” means, in the context of COMAR 10.09.69, a signed and dated written notation by the home care nurse, home health aide, or certified nursing assistant which:</text> <paragraph num="(a)"> <text>Summarizes facts about the care given and the participant's response during a given period of time;</text> </paragraph> <paragraph num="(b)"> <text>Specifically addresses the established goals of treatment;</text> </paragraph> <paragraph num="(c)"> <text>Is consistent with the participant's case management plan; and</text> </paragraph> <paragraph num="(d)"> <text>Is written during the course of care.</text> </paragraph> </paragraph> <paragraph num="(148)"> <text>“Prosthetic device” means an artificial device to replace, in whole or in part, a leg, an arm, an eye, or breast, including surgical brassiere.</text> </paragraph> <paragraph num="(149)"> <text>“Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(150)"> <text>“Provider panel” means that group of providers employed by the MCO or with which the MCO contracts to provide services to the MCO's enrollees under the MCO's health benefit plan, which is at least equivalent to the benefits specified in COMAR 10.67.06.</text> </paragraph> <paragraph num="(151)"> <text>“Public institution” has the meaning stated in COMAR 10.09.24.02.</text> </paragraph> <paragraph num="(152)"> <text>“Quality assurance plan (QAP)” means a document or series of documents that set forth an MCO's strategy for systematically monitoring, evaluating, and improving all facets of MCO operations, including, but not limited to, clinical health care delivery, enrollee assistance and outreach services, and administrative services.</text> </paragraph> <paragraph num="(153)"> <text>“Rare and expensive case management” means the method of health care delivery provided to individuals with rare and expensive conditions.</text> </paragraph> <paragraph num="(154)"> <text>“Rare and expensive condition” means a medical diagnosis or condition identified in COMAR 10.09.69.</text> </paragraph> <paragraph num="(155)"> <text>“Rate adjustment period” has the meaning stated in COMAR 10.67.02.19-4A.</text> </paragraph> <paragraph num="(155-1)"> <text>“Rate year” has the meaning stated in COMAR 10.67.04.19-4A.</text> </paragraph> <paragraph num="(156)"> <text>“Readily accessible” means electronic information and services which comply with modern accessibility standards such as:</text> <paragraph num="(a)"> <text>Section 508 guidelines;</text> </paragraph> <paragraph num="(b)"> <text>Section 504 of the Rehabilitation Act; or</text> </paragraph> <paragraph num="(c)"> <text>W3C's Web Content Accessibility Guidelines (WCAG) 2.0 AA and successor versions.</text> </paragraph> </paragraph> <paragraph num="(157)"> <text>“Reasonable allowable costs” means costs that are related to the provision of covered Medicaid services and are determined to be allowable in accordance with Medicare principles of reasonable cost reimbursement in 42 CFR 413, subject to the limitations specified in COMAR 10.09.08.05C.</text> </paragraph> <paragraph num="(158)"> <text>“Recipient” or “Program recipient” means an individual who is certified as eligible to receive Medical Assistance benefits, as provided in COMAR 10.09.24.</text> </paragraph> <paragraph num="(159)"> <text>“REM optional services” means, in the context of COMAR 10.09.69, the services which meet the general requirements under Regulation .08 and are listed in Regulations .10 and .11 of that chapter.</text> </paragraph> <paragraph num="(160)"> <text>“School-based health center (SBHC)” means a provider located on school grounds that meets the requirements set forth in COMAR 10.09.76.</text> </paragraph> <paragraph num="(161)"> <text>“Secretary” means the Secretary of Health.</text> </paragraph> <paragraph num="(162)"> <text>“Self-referral services” are the health care services listed in COMAR 10.67.06.28 for which, under specified circumstances, the MCO is required to pay, without any requirement of referral by the PCP or MCO, when the enrollee accesses the service through a provider other than the enrollee's PCP.</text> </paragraph> <paragraph num="(162-1)"> <text>“Separate CHIP Program” means the program for targeted low-income children established under Title XXI of the Social Security Act.</text> </paragraph> <paragraph num="(163)"> <text>“Service area” means a geographical area, comprised of one or more of Maryland's counties, with each selected county included in its entirety.</text> </paragraph> <paragraph num="(164)"> <text>“Service year” in the context of COMAR 10.67.04.19-4, means the calendar year in which an MCO incurs the expenses reported pursuant to COMAR 10.67.04.15E(5)(c).</text> </paragraph> <paragraph num="(165)"> <text>“Somatic care” means medical care that addresses an individual's physical health care needs.</text> </paragraph> <paragraph num="(166)"> <text>“Special needs population” means a group of recipients who share a special health care need as specified in COMAR 10.67.04.04.</text> </paragraph> <paragraph num="(167)"> <text>“Special rehabilitation hospital” has the meaning stated in Health-General Article, §19-307(a)(iii), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(168)"> <text>“Specialty behavioral health services” means any behavioral health services other than primary behavioral health services.</text> </paragraph> <paragraph num="(169)"> <text>“Specialty care” means health care services that are either outside the PCP's scope of practice or, in the judgment of the PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in.</text> </paragraph> <paragraph num="(170)"> <text>“Specialty care residency slots” means, in the context of COMAR 10.67.11, positions in a teaching hospital's residency program occupied after completion of a medical degree program by physicians who have trained in specialties other than family medicine, internal medicine, pediatrics, or obstetrics and gynecology.</text> </paragraph> <paragraph num="(171)"> <text>“Spend down” means a procedure by which an individual applying for Medical Assistance who is otherwise ineligible due to excess income becomes eligible by deducting incurred medical expenses from excess income.</text> </paragraph> <paragraph num="(172)"> <text>“State fair hearing” means a hearing, conducted by the Office of Administrative Hearings, for the purpose of ensuring the right of recipients to be treated in a fair and unbiased manner in their efforts to resolve disputes with the Department or an MCO.</text> </paragraph> <paragraph num="(173)"> <text>“Subcontract” means a written agreement between an MCO and a third party, under which the third party performs any one or more of the MCO's obligations required by the Department.</text> </paragraph> <paragraph num="(174)"> <text>“Subcontractor” means an individual or entity that has a contract with an MCO that relates directly or indirectly to the performance of the MCOs obligations under its contract with the Department; provided, however, that a contract does not by itself cause an MCOs network provider to be a subcontractor.</text> </paragraph> <paragraph num="(175)"> <text>“Substantial minority” means an ethnic or linguistic group that comprises 5 percent or more of the Medicaid population in the county to be served.</text> </paragraph> <paragraph num="(176)"> <text>“Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq.</text> </paragraph> <paragraph num="(177)"> <text>“Systems performance review (SPR)” means an assessment, as a component of the quality assurance (QA) audit, of quality assurance operations taking place in the MCO.</text> </paragraph> <paragraph num="(178)"> <text>“Teaching hospital” means a hospital that:</text> <paragraph num="(a)"> <text>Had HSCRC-approved rates for FY 1995 that included an allowance for GME costs; and</text> </paragraph> <paragraph num="(b)"> <text>During the contract year, operates a graduate medical education program that is accredited by the Accreditation Council for Graduate Medical Education.</text> </paragraph> </paragraph> <paragraph num="(179)"> <text>“Temporary Cash Assistance (TCA)” means a form of cash assistance provided, pursuant to Article 88A, §44A et seq., Annotated Code of Maryland, to assistance units which are technically and financially eligible.</text> </paragraph> <paragraph num="(180)"> <text>“Tertiary care” means health care services provided by highly specialized health care providers which are usually diagnostic or therapeutic in nature and often require highly sophisticated technological and support facilities.</text> </paragraph> <paragraph num="(181)"> <text>“Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition.</text> </paragraph> <paragraph num="(182)"> <text>“Waiver-eligible” means an individual who qualifies for enrollment in the Maryland Medicaid Managed Care Program.</text> </paragraph> <paragraph num="(183)"> <text>“Whistleblower” means an individual who exposes any kind of information or activity that alleges any violation of regulation, statute, contract, policy, or unethical behavior that may be indicative of an individual or entity committing fraud, waste, or abuse against the Medicaid program.</text> </paragraph> <paragraph num="(184)"> <text>“Witness”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§15-101 and 15-103(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); amended permanently effective June 29, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1612); October 14, 2013 (40:20 Md. R. 1652); October 28, 2013 (40:21 Md. R. 1775); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); March 14, 2016 (43:5 Md. R. 385); August 29, 2016 (43:17 Md. R. 955); April 10, 2017 (44:7 Md. R. 355); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.62 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 13, 2022 (49:12 Md. R. 641); November 13, 2023 (50:22 Md. R. 974); August 5, 2024 (51:15 Md. R. 707); June 9, 2025 (52:11 Md. R 532)</annotation> </annotations> </chapter> <chapter num="02" heading="Maryland Medicaid Managed Care Program: Eligibility and Enrollment"> <regulation prefix="Regulation" num=".01" heading="Eligibility."> <paragraph num="A."> <text>Criteria. Except as provided in §B of this regulation, a Program participant shall be enrolled in the Maryland Medicaid Managed Care Program, described in this chapter, if the participant is eligible for receipt of Medical Assistance benefits by qualifying:</text> <paragraph num="(1)"> <text>As categorically needy or medically needy under COMAR 10.09.24, unless the participant is:</text> <paragraph num="(a)"> <text>65 years old or older;</text> </paragraph> <paragraph num="(b)"> <text>Newly eligible and 64 1/2 years old or older;</text> </paragraph> <paragraph num="(c)"> <text>Eligible to receive Medicare benefits;</text> </paragraph> <paragraph num="(d)"> <text>Determined medically needy under a spend down; or</text> </paragraph> <paragraph num="(e)"> <text>Otherwise certified for a period of less than 9 months;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For the Pregnant Women and Children's Program on or after January 1, 1997; or</text> </paragraph> <paragraph num="(3)"> <text>For the Maryland Children’s Health Program on or after July 1, 1998; or</text> </paragraph> <paragraph num="(4)"> <text>For the Separate CHIP Program and CHIP Health Services Initiative on or after July 1, 2023.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A participant is not eligible for the Maryland Medicaid Managed Care Program if the participant:</text> <paragraph num="(1)"> <text>Has been, or is expected to be, continuously institutionalized for more than:</text> <paragraph num="(a)"> <text>90 successive days in a long-term care facility; or</text> </paragraph> <paragraph num="(b)"> <text>30 successive days in an institution for mental disease (IMD);</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is institutionalized in an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID);</text> </paragraph> <paragraph num="(3)"> <text>Is enrolled in:</text> <paragraph num="(a)"> <text>Home Care for Disabled Children under a Model Waiver, pursuant to COMAR 10.09.27;</text> </paragraph> <paragraph num="(b)"> <text>The Family Planning Waiver Program pursuant to COMAR 10.09.58; or</text> </paragraph> <paragraph num="(c)"> <text>The Employed Individuals with Disabilities Program pursuant to COMAR 10.09.41;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Is a child receiving adoption subsidy who is covered under the parent's private insurance;</text> </paragraph> <paragraph num="(5)"> <text>Is a child under State supervision receiving adoption subsidy who lives outside of the State;</text> </paragraph> <paragraph num="(6)"> <text>Is a child in an out-of-State placement; or</text> </paragraph> <paragraph num="(7)"> <text>Is an inmate as defined in COMAR 10.67.01.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Enrollment."> <paragraph num="A."> <text>The Department shall make available through its website and upon request provide a paper copy of the following:</text> <paragraph num="(1)"> <text>Materials regarding each MCO providing services in the eligible individual’s county of residence including, but not limited to:</text> <paragraph num="(a)"> <text>Information about how to access the provider directory and drug formulary, with instructions for how to request paper copies if needed;</text> </paragraph> <paragraph num="(b)"> <text>A schedule of the benefits offered, including any benefits offered beyond the basic required package described in COMAR 10.67.06;</text> </paragraph> <paragraph num="(c)"> <text>Which, if any, benefits are provided directly by the Department;</text> </paragraph> <paragraph num="(d)"> <text>If applicable, a list of services that the MCO does not provide, reimburse for, or provide coverage of, because of moral or religious objections, and information about where and how to obtain these services;</text> </paragraph> <paragraph num="(e)"> <text>The requirements for each MCO to provide adequate access to covered services, including the network adequacy standards established in COMAR 10.67.05; and</text> </paragraph> <paragraph num="(f)"> <text>Quality and performance indicators for each MCO, including enrollee satisfaction; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Materials about the managed care program, including:</text> <paragraph num="(a)"> <text>The MCO enrollment and disenrollment process; and</text> </paragraph> <paragraph num="(b)"> <text>The basic features of managed care.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Any forms necessary to select an MCO; and</text> </paragraph> <paragraph num="(4)"> <text>The toll-free telephone number of the enrollment unit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Only the Department, or its designee, is authorized to enroll individuals into MCOs.</text> </paragraph> <paragraph num="C."> <text>A participant found eligible for Maryland Medicaid under 42 U.S.C §1902(a)(10)A(i) shall be assigned to:</text> <paragraph num="(1)"> <text>The MCO the participant chooses at the time of application; or</text> </paragraph> <paragraph num="(2)"> <text>If the participant does not choose, an MCO with available capacity that is accepting new participants in the participant’s service area.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Except for a participant found eligible as described in §C of this regulation, a participant, including a child in foster care or kinship care, shall:</text> <paragraph num="(1)"> <text>Have 28 days from the day the Department mails its eligibility notification in which to select an MCO; or</text> </paragraph> <paragraph num="(2)"> <text>Be assigned to an MCO with available capacity that is accepting new participants in the participant’s service area.</text> </paragraph> </paragraph> <paragraph num="E."> <text>All Managed Care Program eligible family members who live in the same household shall be assigned to the same MCO.</text> </paragraph> <paragraph num="F."> <text>Newborns.</text> <paragraph num="(1)"> <text>A newborn shall be automatically enrolled from birth in its biological mother’s MCO.</text> </paragraph> <paragraph num="(2)"> <text>The MCO is responsible for the newborn’s health care from birth until the newborn enrolls into another MCO.</text> </paragraph> <paragraph num="(3)"> <text>A newborn, automatically assigned to its biological mother’s MCO, is not eligible to change MCOs for family unity as described in COMAR 10.67.02.06A(1)(b) and (c) during the first 90 days of enrollment.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Effective Date of Enrollment. Enrollment in an MCO shall be effective at 12:01 a.m. on the 10th calendar day beginning with the day on which the Department notifies the MCO of the enrollment.</text> </paragraph> <paragraph num="H."> <text>Upon the approval of the Department and the MCO, a participant may select an MCO that does not serve the participant’s service area.</text> </paragraph> <paragraph num="I."> <text>The Department or its designee shall submit the enrollee's choice of PCP to the enrollee's selected MCO at the time of enrollment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Health Service Needs Information."> <paragraph num="A."> <text>The Department, MCO, or agents of the Department or MCO shall attempt to complete the health service needs information at the time of enrollment.</text> </paragraph> <paragraph num="B."> <text>The Department shall transmit any information obtained from health service needs information to the enrollee’s MCO within 5 business days.</text> </paragraph> <paragraph num="C."> <text>Upon its receipt and review of the health service needs information, an MCO shall take appropriate action to ensure that a new enrollee, who needs special or immediate health care services, as identified by the health service needs information, receives them in a timely manner.</text> </paragraph> <paragraph num="D."> <text>If the Department does not transmit health services needs information for an enrollee to the MCO within 10 days of enrollment, the MCO shall make at least two attempts to conduct an initial screening of the enrollee’s needs, within 90 days of the effective date of enrollment. At least one of these attempts shall be during non-working hours.</text> </paragraph> <paragraph num="E."> <text>The Department shall inform an enrollee identified in connection with the health service needs information as having a behavioral health problem that the individual may self-refer to the behavioral health ASO for services as described in COMAR 10.09.59 and 10.09.80.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Assignment to Primary Care Provider (PCP)."> <paragraph num="A."> <text>Within 10 days of the notification of enrollment of a new enrollee or within 10 days of any event that requires a change in an existing enrollee's PCP, an MCO shall notify the enrollee of the enrollee's PCP assignment.</text> </paragraph> <paragraph num="B."> <text>A Program recipient with no previous affiliation with any of the providers on the MCO's primary care provider panel who:</text> <paragraph num="(1)"> <text>Indicates a preference for a participating PCP during the enrollment process shall be assigned to that PCP unless the MCO documents in writing, for good cause, its inability to assign the enrollee to that PCP; or</text> </paragraph> <paragraph num="(2)"> <text>Fails to make known any preference for a PCP shall be assigned to a PCP whose location satisfies the access standards specified in COMAR 10.67.05.06E.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Before changing an enrollee’s PCP, the MCO shall obtain the Department’s approval at least 60 days before the reassignment is effective unless:</text> <paragraph num="(1)"> <text>The PCP has decided to stop practicing;</text> </paragraph> <paragraph num="(2)"> <text>The PCP has terminated the relationship with an enrollee due to the enrollee’s behavior;</text> </paragraph> <paragraph num="(3)"> <text>The change is requested by the enrollee; or</text> </paragraph> <paragraph num="(4)"> <text>The age limits of the PCP's practice no longer meet the needs of the enrollee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Reassignment."> <paragraph num="A."> <text>Once every 12 months, a Program recipient may elect to:</text> <paragraph num="(1)"> <text>Maintain enrollment with the recipient's current MCO;</text> </paragraph> <paragraph num="(2)"> <text>Enroll in another MCO in the recipient's local access area; or</text> </paragraph> <paragraph num="(3)"> <text>Enroll in an MCO outside the recipient’s local access area, upon the approval of the Department and the MCO.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall notify the enrollee no less than 60 days before the start of each new enrollment period.</text> </paragraph> <paragraph num="C."> <text>The Department shall reassign into the same MCO from which the recipient was last enrolled any recipient disenrolled from an MCO who, within 120 days of disenrollment, regains:</text> <paragraph num="(1)"> <text>Eligibility for Medicaid; or</text> </paragraph> <paragraph num="(2)"> <text>Maryland Medicaid Managed Care Program eligibility lost for any of the reasons listed in Regulation .06B of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The MCO shall assign the recipient to the primary care provider of record at the time of the recipient's disenrollment.</text> </paragraph> <paragraph num="E."> <text>A Program participant who has been disenrolled from an MCO because the Department terminated the MCO's contract shall be assigned to another MCO subject to Regulation .02D of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Disenrollment."> <paragraph num="A."> <text>Enrollee-Initiated Disenrollment for Cause.</text> <paragraph num="(1)"> <text>An enrollee may disenroll from an MCO and enroll into another MCO if:</text> <paragraph num="(a)"> <text>The enrollee moves to a county that is not served by the enrollee's present MCO;</text> </paragraph> <paragraph num="(b)"> <text>The family members are enrolled in different MCOs and the adult enrollee requests that other family members be enrolled in one of the MCOs in which another family member is currently enrolled;</text> </paragraph> <paragraph num="(c)"> <text>The enrollee requests enrollment into the MCO that contracts with the PCP of any other family member who is not a HealthChoice enrollee;</text> </paragraph> <paragraph num="(d)"> <text>The enrollee moves or becomes homeless, creating a transportation hardship that may be resolved by enrollment into another MCO serving the enrollee's new local access areas;</text> </paragraph> <paragraph num="(e)"> <text>The enrollee requests a change of MCO within 90 days after the termination of the enrollee's primary care provider's (PCP's) contract if the PCP's contract with the enrollee's MCO, MCO's medical management group, or its subcontractors is terminating for the following reasons:</text> <paragraph num="(i)"> <text>By the MCO for reasons other than the quality of care or the PCP's failure to comply with contractual requirements related to quality assurance activities; or</text> </paragraph> <paragraph num="(ii)"> <text>The MCO's reduction of PCP's reimbursement to the extent that the reduction in rate is greater than the actual change in capitation paid to the MCO by the Department, and the MCO and PCP's inability to negotiate a mutually acceptable rate;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>The enrollee is automatically assigned to an MCO or it is the enrollee's initial enrollment in an MCO as follows:</text> <paragraph num="(i)"> <text>Only one request during the first 90 days of automatic assignment or initial enrollment into an MCO; and</text> </paragraph> <paragraph num="(ii)"> <text>The enrollee is not hospitalized at the time of the request;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>The MCO terminates its contract with the Department in which case:</text> <paragraph num="(i)"> <text>The MCO shall provide written notice to the recipient at least 60 days before the date on which the MCO will exit the HealthChoice Program;</text> </paragraph> <paragraph num="(ii)"> <text>The MCO shall include in the notice the name and provider number of the PCP assigned to the recipient and the telephone number of the enrollment broker;</text> </paragraph> <paragraph num="(iii)"> <text>The Department shall send a notice to every enrollee of the MCO regarding the MCO's termination of its contract with the Department, at least 30 days before the effective date of the termination of the contract;</text> </paragraph> <paragraph num="(iv)"> <text>An enrollee shall have at least 30 days before the effective date of the MCO's contract termination with the Department to choose another MCO, or will be assigned to another MCO; and</text> </paragraph> <paragraph num="(v)"> <text>An enrollee may choose another MCO one additional time within at least 90 days after reenrollment into the new MCO;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>The MCO is acquired by another entity in which case:</text> <paragraph num="(i)"> <text>The MCO shall provide written notice to the recipient at least 60 days before the date on which the MCO will exit the HealthChoice Program;</text> </paragraph> <paragraph num="(ii)"> <text>The MCO shall include in the notice the name and provider number of the PCP assigned to the recipient and the telephone number of the enrollment broker;</text> </paragraph> <paragraph num="(iii)"> <text>The Department shall send a notice to every enrollee of the MCO regarding the change in ownership, 30 days before the effective date of the change of ownership;</text> </paragraph> <paragraph num="(iv)"> <text>An enrollee shall have 30 days before the change of ownership to disenroll from the MCO into another participating MCO;</text> </paragraph> <paragraph num="(v)"> <text>If an enrollee does not choose to disenroll in accordance with §A(1)(f)(ii) of this regulation, the enrollee will be reenrolled in the newly purchased MCO; and</text> </paragraph> <paragraph num="(vi)"> <text>An enrollee may choose another MCO one additional time within at least 90 days after reenrollment in the newly purchased MCO;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>The MCO does not, because of moral or religious objections, cover the service the enrollee seeks;</text> </paragraph> <paragraph num="(j)"> <text>All of the following apply:</text> <paragraph num="(i)"> <text>The enrollee needs related services to be performed at the same time;</text> </paragraph> <paragraph num="(ii)"> <text>Not all related services are available within the network; and</text> </paragraph> <paragraph num="(iii)"> <text>The enrollee's PCP or other provider determines that receiving the services separately would subject the enrollee to unnecessary risk; or</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>The Department imposes the intermediate sanction specified in 42 CFR §438.702(a) and (b), as amended.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall provide timely notification to the affected MCO of an enrollee's intention to disenroll under §A of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall allow disenrollments, subject to the Department's approval, for other reasons, including but not limited to:</text> <paragraph num="(a)"> <text>Poor quality of care;</text> </paragraph> <paragraph num="(b)"> <text>Lack of access to services covered under the contract; or</text> </paragraph> <paragraph num="(c)"> <text>Access to providers experienced in dealing with the enrollee's health care needs.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Enrollees shall make an oral or written request to the Department's enrollment agent for disenrollment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Department-Initiated Disenrollment. The Department shall disenroll from an MCO an enrollee:</text> <paragraph num="(1)"> <text>Subject to the MCO or long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary, who has been continuously institutionalized for a period of more than 90 successive days in a long-term care facility;</text> </paragraph> <paragraph num="(2)"> <text>Upon admission to an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID);</text> </paragraph> <paragraph num="(3)"> <text>Determined eligible for rare and expensive case management pursuant to COMAR 10.09.69;</text> </paragraph> <paragraph num="(4)"> <text>Who loses Medicaid eligibility or who changes to an assistance category not eligible for MCO enrollment, subject, however, to Regulation .01 of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Upon the termination of the contract between the enrollee's MCO and the Department;</text> </paragraph> <paragraph num="(6)"> <text>Who has died;</text> </paragraph> <paragraph num="(7)"> <text>Who has not been validly enrolled in the MCO;</text> </paragraph> <paragraph num="(8)"> <text>Who is 65 years old or older;</text> </paragraph> <paragraph num="(9)"> <text>Who is an inmate of a public institution, including a State operated institution or facility; or</text> </paragraph> <paragraph num="(10)"> <text>Who is eligible to receive Medicare benefits.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department may disenroll individuals from an MCO which the Maryland Insurance Administration has put into rehabilitation or liquidation pursuant to Health-General Article, §15-102.2, Annotated Code of Maryland.</text> </paragraph> <paragraph num="D."> <text>MCO Initiated Disenrollment.</text> <paragraph num="(1)"> <text>An MCO may request disenrollment of an enrollee who has:</text> <paragraph num="(a)"> <text>Moved outside of the MCO's service area; or</text> </paragraph> <paragraph num="(b)"> <text>Become ineligible for continued enrollment for one of the reasons specified in §B of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO may not request disenrollment as specified in 42 CFR §438.56(b)(2), as amended.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Effective Date of Disenrollment.</text> <paragraph num="(1)"> <text>Except as specified in §E(2)—(6) of this regulation, an enrollee's disenrollment is effective on the 10th calendar day after the enrollee selects a new MCO.</text> </paragraph> <paragraph num="(2)"> <text>An enrollee's disenrollment shall take effect:</text> <paragraph num="(a)"> <text>Immediately when the enrollee dies;</text> </paragraph> <paragraph num="(b)"> <text>From the first day of the month following the month that the enrollee lost Medicaid eligibility;</text> </paragraph> <paragraph num="(c)"> <text>On the first day of the month following the month in which the Department receives the required notification, when the enrollee permanently relocates outside of the State; or</text> </paragraph> <paragraph num="(d)"> <text>From the first day of the month following the month in which the Department verifies an enrollee is an inmate.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>When an enrollee becomes eligible for Medicare, the enrollee’s disenrollment from the MCO is effective on the:</text> <paragraph num="(a)"> <text>First day of the month following the month in which the Program receives notice of Medicare eligibility; or</text> </paragraph> <paragraph num="(b)"> <text>Last day of the month before the month in which the enrollee turns 65 years old.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Termination of enrollment resulting from termination of the contract between the Department and an MCO shall be effective on the date the Department terminates the contract.</text> </paragraph> <paragraph num="(5)"> <text>Termination of enrollment resulting from the MCO being placed into rehabilitation or liquidation by the Maryland Insurance Administration shall be effective on the date the Department notifies the MCO of the disenrollment.</text> </paragraph> <paragraph num="(6)"> <text>In the case of an enrollee's death, the Department has the right to recover any capitation payments made on behalf of an enrollee for the period beginning on the date of death.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An MCO shall:</text> <paragraph num="(1)"> <text>Make a good faith effort to give written notice to the Department when enrollees have the right to change MCOs under §A(1)(e) of this regulation 90 days before the effective date of the termination;</text> </paragraph> <paragraph num="(2)"> <text>Provide the Department with a list of the affected enrollees in a format specified by the Department; and</text> </paragraph> <paragraph num="(3)"> <text>If applicable, provide the termination survey required under COMAR 10.67.04.17B(4).</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department shall notify enrollees who may change MCOs under §A(1)(e) of this regulation.</text> </paragraph> <paragraph num="H."> <text>At the Department’s discretion, an MCO may be required to reimburse the Department for the costs associated with the mailing of the notifications in §G of this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730);adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective April 19, 2010 (37:8 Md. R. 615); March 14, 2016 (43:5 Md. R. 385); August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 18, 2002 (29:3 Md. R. 220); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1612); October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); May 22, 2017 (44:1 Md. R. 472)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C repealed effective December 20, 2004 (31:25 Md. R. 1790)</annotation> <annotation type="History" subtype="Administrative History">Regulation.02 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 18, 2002 (29:3 Md. R. 220); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective June 30, 2008 (35:13 Md. R. 1180); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D, E amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02H and .06F amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .02H amended effective February 9, 1998 (25:3 Md. R. 144); February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02I amended effective December 24, 2012 (39:25 Md. R. 1612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L adopted effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 28, 2013 (40:21 Md. R. 1775); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation.04 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation.04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 24, 2012 (39:25 Md. R. 1612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05 amended effective February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation.05B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05E amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation.05F, G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G, H adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G, H repealed effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 25, 2001 (28:12 Md. R. 1109); February 18, 2002 (29:3 Md. R. 220); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation.06A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, B amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A, D amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 6, 2012 (39:2 Md. R. 141); October 14, 2013 (40:20 Md. R. 1652); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, F amended as an emergency provision effective January 1, 2001 (28:4 Md. R. 414)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, F amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective April 9, 2007 (34:7 Md. R. 698); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06I adopted effective February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.63 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> </annotations> </chapter> <chapter num="03" heading="Maryland Medicaid Managed Care Program: MCO Application"> <regulation prefix="Regulation" num=".01" heading="Repealed." /> <regulation prefix="Regulation" num=".02" heading="Application."> <paragraph num="A."> <text>When applying for participation in the Maryland Medicaid Managed Care Program as an MCO, an applicant shall submit an application to the Secretary in the form that the Secretary requires.</text> </paragraph> <paragraph num="B."> <text>An applicant may omit from its application any information or documents that it has previously submitted to the Department, if:</text> <paragraph num="(1)"> <text>The information or documents are up to date; and</text> </paragraph> <paragraph num="(2)"> <text>The applicant identifies in its application the information and documents that it has omitted.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organization, Operations, and Financing."> <text>Except as provided in Regulation .02B of this chapter, an MCO applicant shall include the following information or descriptions in its application:</text> <paragraph num="A."> <text>An indication whether the applicant is an operating HMO with a certificate of authority from the Maryland Insurance Administration;</text> </paragraph> <paragraph num="B."> <text>A written legal history of the applicant, specific as to dates and parties involved, that includes, but is not limited to:</text> <paragraph num="(1)"> <text>Predecessor corporations;</text> </paragraph> <paragraph num="(2)"> <text>Mergers;</text> </paragraph> <paragraph num="(3)"> <text>Reorganizations; and</text> </paragraph> <paragraph num="(4)"> <text>Changes of ownership;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A copy of the articles of incorporation of the applicant, and any amendments to it, certified by the Maryland Department of Assessments and Taxation;</text> </paragraph> <paragraph num="D."> <text>A copy of the applicant's current bylaws, certified by the appropriate corporate officer;</text> </paragraph> <paragraph num="E."> <text>A written description providing a reason if the applicant has ever defaulted on a contract or otherwise had a contract terminated;</text> </paragraph> <paragraph num="F."> <text>If the applicant is an HMO, the most recent annual loss ratio report provided to the Maryland Insurance Administration pursuant to Insurance Article, §5-605, Annotated Code of Maryland;</text> </paragraph> <paragraph num="G."> <text>A copy of the applicant's business plan provided to the Maryland Insurance Administration pursuant to Insurance Article, §5-605, Annotated Code of Maryland.</text> </paragraph> <paragraph num="H."> <text>Evidence of compliance with Maryland Workers' Compensation Law, as follows:</text> <paragraph num="(1)"> <text>Except as provided in §H(2) of this regulation, the applicant shall submit:</text> <paragraph num="(a)"> <text>The policy number of its Workers' Compensation insurance coverage; and</text> </paragraph> <paragraph num="(b)"> <text>The name of its Workers' Compensation insurance carrier; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If self-insured, the applicant shall submit a certificate of compliance evidencing employee coverage under Workers' Compensation Law, as provided in Labor and Employment Article, Title 9, Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="I."> <text>The names, addresses, and official capacities of the managing employees or other individuals responsible for the conduct of the affairs of the applicant, including concise position descriptions and background, citing education, training, and experience, for, but not limited to, the applicant's:</text> <paragraph num="(1)"> <text>Chief Executive Officer;</text> </paragraph> <paragraph num="(2)"> <text>Chief Medical Officer;</text> </paragraph> <paragraph num="(3)"> <text>Chief Information Officer;</text> </paragraph> <paragraph num="(4)"> <text>Chief Financial Officer;</text> </paragraph> <paragraph num="(5)"> <text>Chief Quality Officer;</text> </paragraph> <paragraph num="(6)"> <text>Clinical Operations Manager;</text> </paragraph> <paragraph num="(7)"> <text>Chief Operating Officer;</text> </paragraph> <paragraph num="(8)"> <text>Marketing Director;</text> </paragraph> <paragraph num="(9)"> <text>Program Integrity Director;</text> </paragraph> <paragraph num="(10)"> <text>Health Equity Director;</text> </paragraph> <paragraph num="(11)"> <text>Chief Compliance Officer;</text> </paragraph> <paragraph num="(12)"> <text>Appeals and Grievances Manager;</text> </paragraph> <paragraph num="(13)"> <text>Provider Relations Manager;</text> </paragraph> <paragraph num="(14)"> <text>Special Needs Coordinator, as defined in COMAR 10.67.04.04; and</text> </paragraph> <paragraph num="(15)"> <text>Newborn Coordinator, as defined in COMAR 10.67.04.27;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A full disclosure of the extent and nature of any contracts or arrangements, including any possible conflicts of interest between the applicant and any individual specified in §I of this regulation;</text> </paragraph> <paragraph num="K."> <text>The name and address of each person with a 5 percent or more ownership or controlling interest in the applicant or in any subcontractor or supplier in which the applicant has direct or indirect ownership of 5 percent or more, including identifying whether any person named is related to any other named person as either spouse, parent, child, or sibling;</text> </paragraph> <paragraph num="L."> <text>A list of any subcontractors or suppliers owned by the applicant, indicating the percent of financial interest held;</text> </paragraph> <paragraph num="M."> <text>A history of any subcontractors with whom the applicant has had business transactions totaling more than $25,000 during the 12-month period ending on the date of application;</text> </paragraph> <paragraph num="N."> <text>A description of the applicant's corporate and organizational structure, and an organizational chart, with detailed lines of authority indicating the relationships among the board of directors, the administrative component, and the medical and health service delivery component of the applicant including, but not limited to, staff positions responsible for the plan's key management functions enumerated in §I of this regulation;</text> </paragraph> <paragraph num="O."> <text>A description of all current contractual relationships between the applicant and subcontractors for administrative/management, health, and marketing services, including the subcontractors' names;</text> </paragraph> <paragraph num="P."> <text>A description of any contracts the applicant intends to enter into before beginning operation as an MCO;</text> </paragraph> <paragraph num="Q."> <text>The name of any person or persons holding an ownership or controlling interest in excess of 5 percent in the applicant, or who is an agent or managing employee of the applicant, who has been subject to a conviction as defined at 42 U.S.C. §1320a-7(i), or a sanction for a Program-related offense;</text> </paragraph> <paragraph num="R."> <text>Copies of all standard subcontracts with service and administrative providers who are not salaried employees of the applicant, including identification of any provision in subcontracts which differ from the standard subcontract;</text> </paragraph> <paragraph num="S."> <text>A description of the method by which the applicant will accomplish cost avoidance or recovery in the case of third-party liability; and</text> </paragraph> <paragraph num="T."> <text>Copies of the applicant’s written Medicaid marketing plan including:</text> <paragraph num="(1)"> <text>A description of how the applicant plans to address the special access provisions in COMAR 10.67.05.01D; and</text> </paragraph> <paragraph num="(2)"> <text>Sample version of all material and communication the applicant would like to distribute to potential enrollees, including but not limited to:</text> <paragraph num="(a)"> <text>Brochures;</text> </paragraph> <paragraph num="(b)"> <text>Fact sheets; and</text> </paragraph> <paragraph num="(c)"> <text>Posters.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Financial Solvency."> <text>An applicant that is not a Maryland certified HMO shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>A table labeled “Insurance Coverage”, specifying the applicant's coverage in insurance types including, but not limited to, reinsurance, risk of insolvency, medical malpractice, general liability, and fidelity bond, and detailing the:</text> <paragraph num="(1)"> <text>Carrier;</text> </paragraph> <paragraph num="(2)"> <text>Entity covered;</text> </paragraph> <paragraph num="(3)"> <text>Description of coverage including deductibles, coinsurance, and minimum and maximum benefits;</text> </paragraph> <paragraph num="(4)"> <text>Premium in effect;</text> </paragraph> <paragraph num="(5)"> <text>Any additional policies to cover new risks associated with anticipated MCO functions; and</text> </paragraph> <paragraph num="(6)"> <text>Any other pertinent arrangements;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Evidence of the applicant's insurance for general liability and medical malpractice in the minimum amounts of $1,000,000 per loss and $3,000,000 in the aggregate;</text> </paragraph> <paragraph num="C."> <text>Evidence that the applicant has on hand sufficient liquid funds or a reasonably adequate cash flow to meet all organizational and administrative expenses incurred or expected to be incurred before commencing operations;</text> </paragraph> <paragraph num="D."> <text>An explanation detailing how the applicant would, if approved, protect itself from insolvency;</text> </paragraph> <paragraph num="E."> <text>A description of how the applicant would, if approved, limit its financial risk;</text> </paragraph> <paragraph num="F."> <text>Document that the applicant has deposited, in a trust account with the State treasury, $100,000 in cash or government securities of the type described in Insurance Article, §5-701(b), Annotated Code of Maryland;</text> </paragraph> <paragraph num="G."> <text>A financial statement audited by an independent certified public accountant of the financial condition of the applicant, including:</text> <paragraph num="(1)"> <text>Assets, liabilities, and minimum tangible net equity;</text> </paragraph> <paragraph num="(2)"> <text>A prospective budget and expected cash flow analysis of the applicant for the first 24 months of its anticipated operation demonstrating financial stability based on reasonable assumptions; and</text> </paragraph> <paragraph num="(3)"> <text>Any other financial information required by the Commissioner to adequately conduct financial examination of an applicant; and</text> </paragraph> </paragraph> <paragraph num="H."> <text>A power of attorney executed by the applicant appointing the Commissioner and the Commissioner's authorized deputies as the true and lawful attorney of the applicant in and for the State upon which may be served all lawful process in any action, proceeding, or cause of action arising in this State against the applicant regarding the solvency and financial condition of the applicant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Access and Capacity."> <paragraph num="A."> <text>An MCO applicant shall include in its application the following information or descriptions:</text> <paragraph num="(1)"> <text>A map or maps showing the county or counties in which the applicant proposes to provide health care services, and the service area boundaries.</text> </paragraph> <paragraph num="(2)"> <text>The name and address of each of the applicant's service delivery sites, and, if applicable, the type of facility licensure of each site, grouped by county;</text> </paragraph> <paragraph num="(3)"> <text>If the applicant is an HMO, the applicant's total prepaid enrollment or client population as of the date of application, with a breakdown by payment source, including Medicare, Medicaid, commercial group, commercial individual, and other enrollment;</text> </paragraph> <paragraph num="(4)"> <text>If the applicant is an HMO, the total of the applicant's current unduplicated fee-for-service patient count, with a breakdown by payment source, including Medicaid, Medicare, commercial group, commercial individual, and other patients (including self-pay);</text> </paragraph> <paragraph num="(5)"> <text>The name and address of each of the applicant's primary and specialty care providers, provided in a format specified by the Department, for distribution to recipients in enrollment packets;</text> </paragraph> <paragraph num="(6)"> <text>The following information, grouped by medical specialty and county, regarding each individual practitioner, including primary care providers and specialists, who will act as a health care provider for the applicant:</text> <paragraph num="(a)"> <text>Name, address, and practice location or locations, including a separate line for each location;</text> </paragraph> <paragraph num="(b)"> <text>State licensure number;</text> </paragraph> <paragraph num="(c)"> <text>Specialty, if applicable, indicating the type of services to be provided on behalf of the applicant;</text> </paragraph> <paragraph num="(d)"> <text>Whether the provider will be a primary care provider;</text> </paragraph> <paragraph num="(e)"> <text>A description of the practitioner's employment relationship to the applicant, including, but not limited to:</text> <paragraph num="(i)"> <text>A salaried employee;</text> </paragraph> <paragraph num="(ii)"> <text>A subcontractor;</text> </paragraph> <paragraph num="(iii)"> <text>An employee of a subcontractor; or</text> </paragraph> <paragraph num="(iv)"> <text>Any other form of contractual or employment relationship;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Any restrictions as to age of patients or numbers of enrollees the provider will serve;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>The procedures for assuring proper credentialing and recredentialing of providers;</text> </paragraph> <paragraph num="(8)"> <text>Documentation that the MCO applicant is able to meet the access standards set forth in COMAR 10.67.05 in each service area the MCO applicant plans to enter;</text> </paragraph> <paragraph num="(9)"> <text>Documentation of any reasons for which they are unable to meet the access requirements of COMAR 10.67.05 in any service area;</text> </paragraph> <paragraph num="(10)"> <text>For each primary care practice location, a specification of:</text> <paragraph num="(a)"> <text>The name, address, and hours of operation; and</text> </paragraph> <paragraph num="(b)"> <text>The staffing at each location, expressed in full-time equivalencies and grouped by medical specialty; and</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>Written protocols detailing how the applicant will provide 24-hour per day, 7-day per week coverage for emergency medical situations, including compliance with MIEMSS protocols and the federal Emergency Medical Treatment and Active Labor Act.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The service area in §A(1) of this regulation shall include at least two underserved counties as defined in §C of this regulation.</text> </paragraph> <paragraph num="C."> <text>An underserved county is a county in which less than three current MCOs are participating and accepting new enrollments.</text> </paragraph> <paragraph num="D."> <text>If there are no underserved counties, applications will not be accepted.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Access and Capacity: Benefits and Appointments."> <text>An MCO applicant shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>Written evidence of the applicant's preparedness to provide benefits equivalent to the benefit level mandated by the Maryland Medical Assistance Program as described in COMAR 10.67.05;</text> </paragraph> <paragraph num="B."> <text>A description of any benefits the applicant proposes to provide in addition to those required by the Maryland Medicaid Managed Care Program, including:</text> <paragraph num="(1)"> <text>Whether there are any limitations on these services; and</text> </paragraph> <paragraph num="(2)"> <text>The name, medical specialty, location, and employment status as enumerated in Regulation .05F(5) of this chapter, of any providers rendering additional services;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A copy of the written procedures specifying how an enrollee may select and change primary care providers;</text> </paragraph> <paragraph num="D."> <text>A written explanation of the applicant's plan to provide adequate case management and continuity of care, including its policies and procedures concerning:</text> <paragraph num="(1)"> <text>Case management;</text> </paragraph> <paragraph num="(2)"> <text>Making appointments;</text> </paragraph> <paragraph num="(3)"> <text>Appointment no-shows;</text> </paragraph> <paragraph num="(4)"> <text>Follow-up for appointment no-shows who are at-risk patients; and</text> </paragraph> <paragraph num="(5)"> <text>Referral claims and reimbursement for authorized noncontractual and out-of-plan provider services;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Documentation of the applicant's preparedness to collaborate with providers of self-referral services, and reimburse at the Department's established fee-for-service rate, for permissible self-referred services as defined in COMAR 10.67.06.28;</text> </paragraph> <paragraph num="F."> <text>Documentation of the applicant's preparedness to provide the full range of EPSDT services;</text> </paragraph> <paragraph num="G."> <text>Documentation of the applicant’s preparedness to work with the Department’s behavioral health ASO for coordination of somatic care, behavioral health care, and all appropriate drug utilization review.</text> </paragraph> <paragraph num="H."> <text>A written explanation of the prospective MCO's plan for providing monthly updates to primary care providers of the enrollees assigned to them;</text> </paragraph> <paragraph num="I."> <text>Documentation of the applicant's plan to satisfy statutory requirements that enrollees be notified of due dates for obtaining immunizations, examinations, and other wellness services;</text> </paragraph> <paragraph num="J."> <text>Documentation of how the applicant will provide timely access to health care services, including but not limited to:</text> <paragraph num="(1)"> <text>Waiting time for telephone calls to be answered;</text> </paragraph> <paragraph num="(2)"> <text>Obtaining appointments; and</text> </paragraph> <paragraph num="(3)"> <text>Waiting times in practitioners' offices;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Documentation of access provisions to address the needs of enrollees who:</text> <paragraph num="(1)"> <text>Do not speak English;</text> </paragraph> <paragraph num="(2)"> <text>Are deaf; or</text> </paragraph> <paragraph num="(3)"> <text>Have one or more physical, mental, or developmental disabilities;</text> </paragraph> </paragraph> <paragraph num="L."> <text>The applicant's proposed written utilization management program that specifies, at a minimum, policies and procedures for:</text> <paragraph num="(1)"> <text>Referral processes;</text> </paragraph> <paragraph num="(2)"> <text>Services requiring preauthorization, including mechanisms for ensuring consistent application and requesting provider consultation when appropriate;</text> </paragraph> <paragraph num="(3)"> <text>Criteria for determining medical necessity;</text> </paragraph> <paragraph num="(4)"> <text>Provider responsibilities for utilization management activities;</text> </paragraph> <paragraph num="(5)"> <text>Case management processes;</text> </paragraph> <paragraph num="(6)"> <text>Utilization tracking mechanisms and the determination of over-utilization and under-utilization of health care services;</text> </paragraph> <paragraph num="(7)"> <text>Integration of activities with quality improvement for provider profiling; and</text> </paragraph> <paragraph num="(8)"> <text>Appeals and grievance processes;</text> </paragraph> </paragraph> <paragraph num="M."> <text>The applicant's proposal to establish and utilize a consumer advisory board, including:</text> <paragraph num="(1)"> <text>The anticipated composition of the board;</text> </paragraph> <paragraph num="(2)"> <text>Identifying staff responsible for serving board needs; and</text> </paragraph> <paragraph num="(3)"> <text>Proposed mechanisms by which the board will furnish the MCO with regular enrollee input;</text> </paragraph> </paragraph> <paragraph num="N."> <text>A written description of the applicant's proposed member services unit, including a consumer services hotline, describing how the applicant will use this:</text> <paragraph num="(1)"> <text>As an information source for enrollees;</text> </paragraph> <paragraph num="(2)"> <text>To respond to enrollees' needs and requests in a timely manner; and</text> </paragraph> <paragraph num="(3)"> <text>To facilitate enrollees' access to needed health care services, including how the hotline will function as a point of entry for complaint resolution and internal grievance procedures;</text> </paragraph> </paragraph> <paragraph num="O."> <text>A written Enrollee Outreach Plan that:</text> <paragraph num="(1)"> <text>Describes how the MCO intends to comply with the outreach, quality assurance, and provision of health care services requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>To the extent that the materials are relevant to the requirements of §O(1) of this regulation, may incorporate by reference written materials provided by the applicant in response to other elements of its application; and</text> </paragraph> </paragraph> <paragraph num="P."> <text>Documentation of any service the MCO elects not to provide, reimburse for, or provide coverage of, because of a moral or religious objection, which shall:</text> <paragraph num="(1)"> <text>Be provided to the Department whenever an MCO adopts the policy during the term of the contract;</text> </paragraph> <paragraph num="(2)"> <text>Be consistent with the provisions of 42 CFR §438.10, as amended; and</text> </paragraph> <paragraph num="(3)"> <text>Be provided to enrollees within 90 days after adopting the policy with respect to any particular service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Access and Capacity: Contracts and Provider Applications."> <text>An MCO applicant shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>A description of the applicant's hiring and subcontracting policies, which shall correspond to the requirements of Insurance Article, §15-112, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>A blank copy of the provider application form;</text> </paragraph> <paragraph num="C."> <text>Documentary assurances that the applicant and its health care providers furnish access on a nondiscriminatory basis, in accordance with State and federal law, to all of their enrollees regardless of gender, race, age, religion, national origin, physical or mental disability, or type of illness or condition;</text> </paragraph> <paragraph num="D."> <text>If the applicant is an HMO that will require its panel providers to participate in the MCO, documentation of the mechanism the MCO will use to make an equitable distribution of enrollees among its panel providers so that no provider is assigned a disproportionate number of enrollees;</text> </paragraph> <paragraph num="E."> <text>Written evidence of the applicant's organizational capacity to provide special programs adequate to meet the individual needs of all enrollees, including:</text> <paragraph num="(1)"> <text>Outreach;</text> </paragraph> <paragraph num="(2)"> <text>Case management;</text> </paragraph> <paragraph num="(3)"> <text>Home visiting;</text> </paragraph> <paragraph num="(4)"> <text>Disease management;</text> </paragraph> <paragraph num="(5)"> <text>Prevention and wellness education; and</text> </paragraph> <paragraph num="(6)"> <text>All Medicaid-covered services required to comply with State statutes and regulations mandating health and behavioral health services for children in State-supervised care;</text> </paragraph> </paragraph> <paragraph num="F."> <text>A written explanation of the applicant's plan for ensuring that each primary and specialty care provider receives a copy of the MCO's Medicaid requirements manual, and any other information necessary to facilitate full compliance with all federal and State Medicaid requirements within 2 weeks after the provider has entered into a contract or has begun employment with the MCO, and updated as necessary thereafter; and</text> </paragraph> <paragraph num="G."> <text>A description of the applicant's plan to accommodate the cultural and ethnic diversity of the populations to be served.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="National Committee on Quality Assurance (NCQA) Accreditation."> <paragraph num="A."> <text>Effective July 1, 2012, an MCO applicant shall obtain NCQA health plan accreditation within 2 years of their effective date as an MCO.</text> </paragraph> <paragraph num="B."> <text>Effective January 1, 2025, an MCO shall obtain NCQA health equity accreditation within 2 years of their effective date as an MCO.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Quality Assurance System — General."> <text>An applicant shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>The applicant's proposed quality assurance plan, that contains, at a minimum, all elements specified by Health-General Article, §15-103(b)(9)(i), Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>A description of any written procedures or protocols regarding physician and nursing care practice the applicant intends to use;</text> </paragraph> <paragraph num="C."> <text>A description of the applicant's peer review committee structure and process;</text> </paragraph> <paragraph num="D."> <text>A copy of the applicant's case management plan;</text> </paragraph> <paragraph num="E."> <text>A description of all mechanisms to be used to ensure the quality of any services, including administrative and clinical, that the applicant intends to delegate to subcontractors;</text> </paragraph> <paragraph num="F."> <text>The name and a description of the published standards or guidelines for maintenance of medical records the applicant will follow;</text> </paragraph> <paragraph num="G."> <text>A description of how providers will be apprised of medical records, utilization review, and case management requirements;</text> </paragraph> <paragraph num="H."> <text>A description of the applicant's system for ensuring inclusion in the medical record of reports of health care services or diagnostic testing performed in a referral setting;</text> </paragraph> <paragraph num="I."> <text>A written description of the applicant's internal review system for the handling, monitoring, and resolution of provider complaints, grievances, and appeals;</text> </paragraph> <paragraph num="J."> <text>Evidence of an adequate system for medical record retention and retrieval that meets, at minimum, all requirements of Health-General Article, §15-103(b)(9)(xiv), Annotated Code of Maryland;</text> </paragraph> <paragraph num="K."> <text>Documentary evidence that the applicant requires school-based clinics to provide information concerning health care services provided to their enrollees;</text> </paragraph> <paragraph num="L."> <text>A copy of the applicant's practice guidelines used to assist practitioners in approaching health care issues in a systematic, appropriate manner;</text> </paragraph> <paragraph num="M."> <text>A copy of the applicant's health education plan;</text> </paragraph> <paragraph num="N."> <text>A written description of the applicant's complaint resolution protocol, which shall, at minimum:</text> <paragraph num="(1)"> <text>Include an internal grievance procedure by which an enrollee who is dissatisfied with the applicant or its providers may seek recourse within the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Specify what constitutes a grievance;</text> </paragraph> <paragraph num="(3)"> <text>Provide for prompt resolution of complaints;</text> </paragraph> <paragraph num="(4)"> <text>Require participation in the grievance process by individuals within the MCO who have the authority to require corrective action;</text> </paragraph> <paragraph num="(5)"> <text>Specify how the MCO will handle formal appeals by enrollees;</text> </paragraph> <paragraph num="(6)"> <text>Include a form that enrollees will use when filing a grievance, including foreign language versions for any substantial minorities in the applicant's proposed MCO service area;</text> </paragraph> <paragraph num="(7)"> <text>Identify the steps in the grievance process, and what personnel will be responsible for receiving, processing, monitoring, and responding to grievances;</text> </paragraph> <paragraph num="(8)"> <text>Specify how the enrollee will be informed that the enrollee's grievance is being investigated, and the protocols by which grievances will be resolved;</text> </paragraph> <paragraph num="(9)"> <text>Describe what methods will be used to inform enrollees about the operation of the grievance procedure; and</text> </paragraph> <paragraph num="(10)"> <text>Describe whether manual or automated processes will be used to track enrollees' complaints, determine any patterns of complaints, and report findings to the proposed MCO's quality assurance or quality improvement system; and</text> </paragraph> </paragraph> <paragraph num="O."> <text>A copy of the MCO's provider education plan.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Special Needs Populations."> <text>An MCO applicant shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>A narrative description of the clinical expertise and experience of the MCO's network for special needs populations in a format specified by the Department;</text> </paragraph> <paragraph num="B."> <text>Written evidence of the applicant's ability to comply with specific quality access, data, and performance measurements to satisfy the general requirements for all special needs populations specified in COMAR 10.67.04.04;</text> </paragraph> <paragraph num="C."> <text>Written evidence, including treatment protocols, of the applicant’s ability to provide the range of clinical and support services specified in COMAR 10.67.04.05—.10 and .13, to ensure appropriate and coordinated services to the following special populations:</text> <paragraph num="(1)"> <text>Children with special health care needs;</text> </paragraph> <paragraph num="(2)"> <text>Individuals with a physical disability;</text> </paragraph> <paragraph num="(3)"> <text>Individuals with a developmental disability;</text> </paragraph> <paragraph num="(4)"> <text>Pregnant and postpartum women;</text> </paragraph> <paragraph num="(5)"> <text>Individuals who are homeless; and</text> </paragraph> <paragraph num="(6)"> <text>Individuals with HIV/AIDS; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Referral protocols that demonstrate the conditions under which PCPs will make the arrangements for children with special health care needs to be referred to MCO specialty care networks and when appropriate the behavioral health ASO for services as described in COMAR 10.09.59 or 10.09.80.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Management Information System and Data Reporting."> <text>An MCO applicant shall include in its application the following information or descriptions:</text> <paragraph num="A."> <text>A description of the applicant's management information system, including, but not limited to:</text> <paragraph num="(1)"> <text>Capacities, including:</text> <paragraph num="(a)"> <text>The ability to generate and transmit electronic claims data consistent with the Medicaid Statistical Information System (MSIS) requirements or successor systems;</text> </paragraph> <paragraph num="(b)"> <text>The ability to collect and report data on enrollee and provider characteristics and on all services furnished to enrollees through an encounter data system;</text> </paragraph> <paragraph num="(c)"> <text>The ability to screen the data collected for completeness, logic, and consistency; and</text> </paragraph> <paragraph num="(d)"> <text>The ability to collect and report data from providers in standardized formats using secure information exchanges and technologies utilized for Medicaid quality improvement and care coordination efforts;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Software;</text> </paragraph> <paragraph num="(3)"> <text>Characteristics; and</text> </paragraph> <paragraph num="(4)"> <text>Ability to interface with other systems;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A description of the applicant's operational procedures for generating service-specific encounter data;</text> </paragraph> <paragraph num="C."> <text>Evidence of the applicant's ability to report, on a monthly basis, service-specific encounter data in UB04 or CMS1500 format;</text> </paragraph> <paragraph num="D."> <text>A description of the applicant's operational procedures for generating financial reports, including, but not limited to:</text> <paragraph num="(1)"> <text>Annual audits;</text> </paragraph> <paragraph num="(2)"> <text>Annual financial statements; and</text> </paragraph> <paragraph num="(3)"> <text>Quarterly unaudited financial statements;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Evidence of the applicant’s ability to collect and report all data necessary to derive indicators for Healthcare Effectiveness Data and Information Set (HEDIS); and</text> </paragraph> <paragraph num="F."> <text>A description of the applicant’s procedures for verifying the accuracy and timeliness of reported data, including data from network providers the MCO was compensating on the basis of capitation payments or other payment arrangements that are not fee-for-service.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article §§15-102 and 15-103, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C repealed effective April 16, 2012 (39:7 Md. R. 492)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F, G amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03H amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03T amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04F amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective December 27, 2010 (37:26 Md. R. 1787); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06G amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07E amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective December 24, 2012 (39:25 Md. R. 1612)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09G amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09K amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C, D amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.64 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I amended effective April 28, 2025 (52:8 Md. R. 359)</annotation> </annotations> </chapter> <chapter num="04" heading="Maryland Medicaid Managed Care Program: Managed Care Organizations"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference — Repealed" /> <regulation prefix="Regulation" num=".02" heading="Conditions for Participation."> <paragraph num="A."> <text>An MCO shall have sufficient provider capacity to provide health care services to Program recipients residing in a geographic region no smaller in size than one county or the City of Baltimore.</text> </paragraph> <paragraph num="B."> <text>An MCO shall comply with COMAR 10.09.36.</text> </paragraph> <paragraph num="C."> <text>An MCO shall enter a memorandum of understanding with each local health department (LHD) in its service area addressing the method by which the MCO and the LHD will collaborate and communicate on matters of mutual interest and concern, including but not limited to the responsibility of the LHD for contact tracing for sexually transmitted diseases and directly observed therapy for tuberculosis.</text> </paragraph> <paragraph num="D."> <text>Assurance Against Insolvency.</text> <paragraph num="(1)"> <text>An MCO shall be actuarially sound.</text> </paragraph> <paragraph num="(2)"> <text>An applicant shall possess an initial surplus in the amount of $1,500,000 as specified in Health-General Article, §15-102.4(a)(2)(ii), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>If the Commissioner determines and reports to the Secretary that the applicant has an initial surplus that is at least $1,250,000 but less than $1,500,000, before approval the Department shall designate funds in trust sufficient to provide an initial surplus of $1,500,000.</text> </paragraph> <paragraph num="(4)"> <text>If the Commissioner determines and reports to the Secretary that the applicant's initial surplus is less than $1,250,000 before approval the Department may, at its discretion, designate funds in trust in an amount equal to:</text> <paragraph num="(a)"> <text>The sum of the amounts due to the owners of the applicant from the Department for Medicaid services provided on a fee-for-service basis, so long as the owners of the applicant have waived in writing their right to receive Medicaid payments until such time as the Department is permitted to remove its funds from the trust account pursuant to §D(6) of this regulation; or</text> </paragraph> <paragraph num="(b)"> <text>If a financial guarantor with sufficient net worth and an adequate history of generating net income agrees to pay claims against the MCO in the case of insolvency, the difference between $1,250,000 and the applicant's initial surplus.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If, in accordance with §D(4) of this regulation, the Department designates funds sufficient to increase the applicants initial surplus to $1,250,000, the Department shall designate $250,000 in trust for the applicant.</text> </paragraph> <paragraph num="(6)"> <text>Funds designated by the Secretary pursuant to §D(3)(5) of this regulation shall remain in trust until such time as the Commissioner has determined that the MCO meets the minimum statutory surplus requirements based on the MCOs annual report submitted pursuant to Insurance Article, §5-605, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>Before approval of an applicant, the Secretary shall notify the Commissioner whether the Secretary has placed any money in trust under this section.</text> </paragraph> <paragraph num="(8)"> <text>In the event of insolvency, the MCO shall cover continuation of services to enrollees for the duration of the period for which capitation payment has been made.</text> </paragraph> <paragraph num="(9)"> <text>An MCO shall meet the solvency standards established by the State for private HMOs, or be licensed or certified by the State as a risk-bearing entity except if the MCO:</text> <paragraph num="(a)"> <text>Is a public entity; or</text> </paragraph> <paragraph num="(b)"> <text>Is, or is controlled by, one or more federally qualified health centers and meets the solvency standards established by the State for those centers;</text> </paragraph> <paragraph num="(c)"> <text>Has its solvency guaranteed by the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Health Care Delivery. An MCO shall:</text> <paragraph num="(1)"> <text>Provide the services set forth in COMAR 10.67.06 promptly and continuously, consistent with good medical practice and community professional standards;</text> </paragraph> <paragraph num="(2)"> <text>Conform with and fulfill the requirements of 42 CFR §422.128, as amended, and provide adult enrollees with written information on advance directives which shall:</text> <paragraph num="(a)"> <text>Include a description of applicable State law; and</text> </paragraph> <paragraph num="(b)"> <text>Reflect a change in State law as soon as possible, but not later than 90 days after the effective date of the change.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide each enrollee within 10 days of notification to the MCO of the enrollees enrollment with a distinctive, durable identification card, clearly indicating the bearer to be a member of the MCO and containing, at a minimum:</text> <paragraph num="(a)"> <text>The enrollee's Medicaid number;</text> </paragraph> <paragraph num="(b)"> <text>The MCO's consumer services hotline telephone number;</text> </paragraph> <paragraph num="(c)"> <text>The Department's enrollee hotline telephone number; and</text> </paragraph> <paragraph num="(d)"> <text>Enrollee's assigned primary care provider's name and telephone number;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Provide enrollees, within 30 days before the intended effective date, written notice when there is a significant change in the nature or location of services provided; and</text> </paragraph> <paragraph num="(5)"> <text>Provide on the card required in §E(3) of this regulation, on a separate prescription benefit card, or other technology, prescription billing information that:</text> <paragraph num="(a)"> <text>Complies with the standards set forth in the National Council for Prescription Drug Programs pharmacy ID card prescription benefit card implementation guide at the time of issuance of the card or other technology; or</text> </paragraph> <paragraph num="(b)"> <text>Includes, at a minimum, the following data elements:</text> <paragraph num="(i)"> <text>The name or identifying trademark of the MCO;</text> </paragraph> <paragraph num="(ii)"> <text>The name and identification number of the recipient;</text> </paragraph> <paragraph num="(iii)"> <text>The telephone number that providers may call for pharmacy benefit assistance; and</text> </paragraph> <paragraph num="(iv)"> <text>All electronic transaction routing information and other numbers required by the MCO or its benefit administrator to process a prescription claim electronically.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>An MCO:</text> <paragraph num="(1)"> <text>Shall comply with the standards in P.L. 101-336, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.;</text> </paragraph> <paragraph num="(2)"> <text>May not discriminate against an enrollee on any basis, including, but not limited to, age, sex, race, creed, color, marital status, sexual orientation, gender identity, national origin, physical or mental handicap, health status, or need for health care services;</text> </paragraph> <paragraph num="(3)"> <text>Shall prepare and make available all publications in a manner consistent with COMAR 10.67.05.01A, including, but not limited to:</text> <paragraph num="(a)"> <text>Provider directories;</text> </paragraph> <paragraph num="(b)"> <text>Enrollee handbooks;</text> </paragraph> <paragraph num="(c)"> <text>Health education materials; and</text> </paragraph> <paragraph num="(d)"> <text>Informational brochures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An MCO shall maintain enrollee medical records in compliance with Health-General Article, §4-301 et seq., Annotated Code of Maryland, and the utilization control requirement of 42 CFR Part 456, as amended.</text> </paragraph> <paragraph num="H."> <text>An MCO shall permit the enrollment of a waiver-eligible Program recipient who is enrolled by the Department or who selects the MCO, unless the MCO's enrollment meets or exceeds any enrollment limits mutually agreed to by the Department and the MCO.</text> </paragraph> <paragraph num="I."> <text>MCO Local Access Area Participation.</text> <paragraph num="(1)"> <text>Effective January 1, 2014, an MCO shall open in all local access areas located within the same county in which the MCO chooses to participate.</text> </paragraph> <paragraph num="(2)"> <text>The MCO shall provide written notification to the Department of the MCO's intent to participate and accept new enrollees in each of the counties by September 15 for the next calendar year.</text> </paragraph> <paragraph num="(3)"> <text>The MCO's decision to accept new enrollees is in effect from January 1 to December 31 unless the Department decides there is adequate justification to waive this requirement, which includes, but is not limited to, a rate cut or an MCO exit from the market.</text> </paragraph> <paragraph num="(4)"> <text>Unless the Department approves a shorter time frame, an MCO that exits the Program during the calendar year shall submit their exit transition plan to the Department 120 days prior to the effective date of the exit.</text> </paragraph> <paragraph num="(5)"> <text>If the MCO has not participated in a county for a period of 12 or more consecutive months, the MCO may participate and accept new enrollees in that county by notifying the Department at least 30 days before accepting new enrollees.</text> </paragraph> <paragraph num="(6)"> <text>An MCO that voluntarily freezes for new enrollments in a county shall remain frozen in that county for the remainder of the calendar year and the following calendar year.</text> </paragraph> <paragraph num="(7)"> <text>If system modifications require longer than 30 days to implement, the effective date may be extended.</text> </paragraph> <paragraph num="(8)"> <text>The MCO shall follow the access standards specified in COMAR 10.67.05.06 and .05-1.</text> </paragraph> </paragraph> <paragraph num="J."> <text>In counties where the MCO decides to stop accepting new enrollees, the MCO shall:</text> <paragraph num="(1)"> <text>Continue to accept enrollees who regain eligibility within 120 days of becoming ineligible for the Program;</text> </paragraph> <paragraph num="(2)"> <text>Accept newborns if the mother is an MCO member at the time of birth; and</text> </paragraph> <paragraph num="(3)"> <text>Accept the family members of enrollees enrolled with the MCO before the effective date that the MCO stopped accepting new enrollees.</text> </paragraph> </paragraph> <paragraph num="K."> <text>An HMO that is approved as an MCO and that requires its panel providers to participate in an MCO shall submit for review by the Secretary its plan to assure the equitable distribution of enrollees and to ensure that a provider is not assigned a disproportionate number of enrollees, as required by Health-General Article, §15-102.5, Annotated Code of Maryland.</text> </paragraph> <paragraph num="L."> <text>An MCO shall comply with the provisions of Insurance Article, §15-112, Annotated Code of Maryland when credentialing providers, and during the credentialing process the MCO:</text> <paragraph num="(1)"> <text>May not discriminate against particular providers that serve high-risk populations or specialize in conditions that require costly treatment;</text> </paragraph> <paragraph num="(2)"> <text>May not employ or contract with providers excluded from participation in federal health care programs under either §1128 or 1128A of the Social Security Act; and</text> </paragraph> <paragraph num="(3)"> <text>Shall give the affected providers written notice of the reason for its decision if the MCO declines to include the providers in its network.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The requirements of Regulation .17A(2) of this chapter, or §L(1) of this regulation, may not be construed to:</text> <paragraph num="(1)"> <text>Require an MCO to contract with providers beyond the number necessary to meet the needs of its enrollees;</text> </paragraph> <paragraph num="(2)"> <text>Preclude an MCO from using different reimbursement amounts:</text> <paragraph num="(a)"> <text>For different specialties; or</text> </paragraph> <paragraph num="(b)"> <text>For different practitioners in the same specialty; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Preclude an MCO from establishing measures that are designed to maintain quality of services and control costs, consistent with its responsibilities to enrollees.</text> </paragraph> </paragraph> <paragraph num="N."> <text>Disclosure of Provider Incentive Plans.</text> <paragraph num="(1)"> <text>An MCO shall disclose to the Department the information on its provider incentive plans listed in 42 CFR §417.479(h)(1):</text> <paragraph num="(a)"> <text>Prior to approval of its contract or agreement; and</text> </paragraph> <paragraph num="(b)"> <text>Upon the contract's or agreement's anniversary or renewal effective date.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO shall include in the disclosures required by §N(1) of this regulation information sufficient for the Department to determine whether the incentive plans meet the requirements of 42 CFR §417.479(d)(g) and, as applicable (i), when there exist compensation arrangements under which payment for designated health services furnished to an individual on the basis of a physician referral would otherwise be denied under §1903(a) of the Social Security Act.</text> </paragraph> </paragraph> <paragraph num="O."> <text>When making a referral, an MCO shall use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06.</text> </paragraph> <paragraph num="P."> <text>An MCO shall meet all other requirements of applicable State and federal law including but not limited to:</text> <paragraph num="(1)"> <text>Title VI of the Civil Rights Act of 1964;</text> </paragraph> <paragraph num="(2)"> <text>Title IX of the Education Amendments of 1972 regarding education programs and activities;</text> </paragraph> <paragraph num="(3)"> <text>The Age Discrimination Act of 1975;</text> </paragraph> <paragraph num="(4)"> <text>The Rehabilitation Act of 1973;</text> </paragraph> <paragraph num="(5)"> <text>Any laws regarding privacy and confidentiality;</text> </paragraph> <paragraph num="(6)"> <text>Any laws that pertain to enrollee rights;</text> </paragraph> <paragraph num="(7)"> <text>45 CFR Part 74, as amended, including particular attention to requirements at 45 CFR §§74.42, 74.43, 74.44, 74.48, and 74. 53(a) and (b), and Appendix A; and</text> </paragraph> <paragraph num="(8)"> <text>Section 1557 of the Affordable Care Act.</text> </paragraph> </paragraph> <paragraph num="Q."> <text>An MCO shall meet all program integrity requirements as set forth in COMAR 10.67.07.</text> </paragraph> <paragraph num="R."> <text>The following applies to the Department's Health Home Program as described in COMAR 10.09.33:</text> <paragraph num="(1)"> <text>The MCO may not provide services that duplicate the CMS reimbursed health home services for members participating in the State's Health Home Program;</text> </paragraph> <paragraph num="(2)"> <text>The State shall inform the MCO of members assigned to the State's Health Home Program so that the MCO can prepare to coordinate care with the health homes;</text> </paragraph> <paragraph num="(3)"> <text>The MCO shall provide a point of contact for the health homes to the State who shall share with all the enrolled health homes;</text> </paragraph> <paragraph num="(4)"> <text>The MCO shall make referrals to the health homes of members who meet the criteria for enrollment in the program;</text> </paragraph> <paragraph num="(5)"> <text>To facilitate this process, the State shall provide information to the MCO on all the enrolled health homes in the MCO's service areas; and</text> </paragraph> <paragraph num="(6)"> <text>The MCO shall assist the health homes as necessary in accessing somatic care services for health home recipients.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Quality Assessment and Improvement."> <paragraph num="A."> <text>An MCO shall have a continuous, systematic program designed to monitor, measure, evaluate, and improve the quality of health care services delivered to enrollees including individuals with special health care needs. At a minimum, the MCO shall:</text> <paragraph num="(1)"> <text>Comply with all applicable federal and State laws and regulations;</text> </paragraph> <paragraph num="(2)"> <text>Comply with all access and quality standards and levels of performance established by the Department including all standards for individuals with special health care needs in Regulations.04—.10 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Be able to provide the Department with timely accurate information in areas including but not limited to:</text> <paragraph num="(a)"> <text>Provider networks;</text> </paragraph> <paragraph num="(b)"> <text>Utilization of services; and</text> </paragraph> <paragraph num="(c)"> <text>Identification and management of individuals with special health care needs, including but not limited to:</text> <paragraph num="(i)"> <text>Enrollees with HIV;</text> </paragraph> <paragraph num="(ii)"> <text>Pregnant women;</text> </paragraph> <paragraph num="(iii)"> <text>Enrollees with disabilities;</text> </paragraph> <paragraph num="(iv)"> <text>Adult enrollees with diabetes;</text> </paragraph> <paragraph num="(v)"> <text>Pediatric enrollees with asthma; and</text> </paragraph> <paragraph num="(vi)"> <text>Children with special health care needs.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall participate in all quality assessment activities required by the Department to determine if the MCO is providing medically necessary enrollee health care. These activities include, but are not limited to:</text> <paragraph num="(1)"> <text>A Systems Performance Review (SPR) performed by an external quality review organization hired by the Department to assess an MCO’s structure and operations in order to determine its ability to provide health care to its enrollees as follows:</text> <paragraph num="(a)"> <text>The SPR shall include, but not be limited to:</text> <paragraph num="(i)"> <text>MCO's Quality Assessment and Improvement program;</text> </paragraph> <paragraph num="(ii)"> <text>Enrollee rights;</text> </paragraph> <paragraph num="(iii)"> <text>Access and availability of services;</text> </paragraph> <paragraph num="(iv)"> <text>Care management;</text> </paragraph> <paragraph num="(v)"> <text>Enrollee outreach;</text> </paragraph> <paragraph num="(vi)"> <text>Utilization management and review; and</text> </paragraph> <paragraph num="(vii)"> <text>MCO organization, operations, and financial management;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The results of the SPR shall be reported in draft to the MCOs for comment;</text> </paragraph> <paragraph num="(c)"> <text>MCO shall submit all comments and any required corrective action within 45 days of receipt of draft report; and</text> </paragraph> <paragraph num="(d)"> <text>The Department shall issue a final report of the SPR results;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The annual collection, validation, and evaluation of the latest approved version of the Healthcare Effectiveness Data and Information Set (HEDIS) in order to assess the access to and quality of services provided, in addition to any additional performance measures specified by the Department or CMS;</text> </paragraph> <paragraph num="(3)"> <text>The annual collection and evaluation of a set of performance measures with targets as determined by the Department as follows:</text> <paragraph num="(a)"> <text>The composition of the core performance measures is listed in §B(3)(d)—(f) of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Each year before the audit period begins, the Department shall identify and obtain public input on all measures to be collected as well as the target for each;</text> </paragraph> <paragraph num="(c)"> <text>In accordance with COMAR 10.67.10, MCOs may receive financial or other types of incentives or disincentives based on performance measure results;</text> </paragraph> <paragraph num="(d)"> <text>Effective January 1, 2017, the core performance measures are:</text> <paragraph num="(i)"> <text>Adolescent well care visits;</text> </paragraph> <paragraph num="(ii)"> <text>Adult Body Mass Index (BMI) assessment;</text> </paragraph> <paragraph num="(iii)"> <text>Ambulatory care for Supplemental Security Income (SSI) adults;</text> </paragraph> <paragraph num="(iv)"> <text>Ambulatory care for Supplemental Security Income (SSI) children;</text> </paragraph> <paragraph num="(v)"> <text>Breast cancer screening;</text> </paragraph> <paragraph num="(vi)"> <text>Childhood immunizations — Combo 3;</text> </paragraph> <paragraph num="(vii)"> <text>Comprehensive diabetes care — HbA1c testing;</text> </paragraph> <paragraph num="(viii)"> <text>Controlling high blood pressure;</text> </paragraph> <paragraph num="(ix)"> <text>Immunization for adolescents;</text> </paragraph> <paragraph num="(x)"> <text>Lead screening for children 12—23 months old;</text> </paragraph> <paragraph num="(xi)"> <text>Asthma medication ratio;</text> </paragraph> <paragraph num="(xii)"> <text>Postpartum care; and</text> </paragraph> <paragraph num="(xiii)"> <text>Well child visits, 3—6 years old;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Effective January 1, 2019, the core performance measures are:</text> <paragraph num="(i)"> <text>Adolescent well care visits;</text> </paragraph> <paragraph num="(ii)"> <text>Ambulatory care for SSI adults;</text> </paragraph> <paragraph num="(iii)"> <text>Ambulatory care for SSI children;</text> </paragraph> <paragraph num="(iv)"> <text>Asthma medication ratio;</text> </paragraph> <paragraph num="(v)"> <text>Breast cancer screening;</text> </paragraph> <paragraph num="(vi)"> <text>Comprehensive diabetes care — HbA1c control (<8.0%);</text> </paragraph> <paragraph num="(vii)"> <text>Controlling high blood pressure;</text> </paragraph> <paragraph num="(viii)"> <text>Lead screening for children 12 through 23 months old; and</text> </paragraph> <paragraph num="(ix)"> <text>Well child visits in the first 15 months of life;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Effective January 1, 2021, the core performance measures are:</text> <paragraph num="(i)"> <text>Adolescent well care visits;</text> </paragraph> <paragraph num="(ii)"> <text>Ambulatory care for SSI adults;</text> </paragraph> <paragraph num="(iii)"> <text>Ambulatory care for SSI children;</text> </paragraph> <paragraph num="(iv)"> <text>Asthma medication ratio;</text> </paragraph> <paragraph num="(v)"> <text>Breast cancer screening;</text> </paragraph> <paragraph num="(vi)"> <text>Comprehensive diabetes care — HbA1c control (<8.0%);</text> </paragraph> <paragraph num="(vii)"> <text>Controlling high blood pressure;</text> </paragraph> <paragraph num="(viii)"> <text>Lead screening for children 12 through 23 months old;</text> </paragraph> <paragraph num="(ix)"> <text>Postpartum care; and</text> </paragraph> <paragraph num="(x)"> <text>Well child visits in the first 15 months of life;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Starting with the 2019 performance measures, the Department shall implement the following methodology for imposing penalties and incentives:</text> <paragraph num="(i)"> <text>There shall be three levels of performance;</text> </paragraph> <paragraph num="(ii)"> <text>Performance shall be evaluated separately for each measure, and each measure shall have equal weight;</text> </paragraph> <paragraph num="(iii)"> <text>On any of the measures in §B(3)(f)(i)—(ix) of this regulation for which the MCO does not meet the minimum target, as determined by the Department, a penalty of 1/9 of 1 percent of the total capitation amount paid to the MCO during the measurement year shall be collected;</text> </paragraph> <paragraph num="(iv)"> <text>The total amount of the penalties as described in §B(3)(h)(iii) of this regulation may not exceed 1 percent of the total capitation amount paid to the MCO during the same measurement year;</text> </paragraph> <paragraph num="(v)"> <text>On any of the measures in §B(3)(f) of this regulation for which the MCO meets or exceeds the incentive target, as determined by the Department, the MCO shall be paid an incentive payment of up to 1/9 of 1 percent of the total capitation paid to the MCO during that measurement year;</text> </paragraph> <paragraph num="(vi)"> <text>The total amount of the incentive payments as described in §B(3)(h)(v) of this regulation paid to the MCOs each year may not exceed the total amount of the penalties as described in §B(3)(g)(iii) of this regulation collected from the MCOs in that same year, plus any additional funds allocated to the Department for a quality initiative; and</text> </paragraph> <paragraph num="(vii)"> <text>Any funds remaining after the payment of the incentives due under §B(3)(h)(v) of this regulation shall be distributed to the MCOs receiving the four highest normalized scores for Value Based Purchasing for all ten performance measures at a rate calculated by multiplying each MCO’s adjusted enrollment as of December 31 of the measurement year by a per enrollee amount;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Starting with the 2021 performance measures, the Department shall implement the following methodology for imposing penalties and incentives:</text> <paragraph num="(i)"> <text>There shall be three levels of performance;</text> </paragraph> <paragraph num="(ii)"> <text>Performance shall be evaluated separately for each measure, and each measure shall have equal weight;</text> </paragraph> <paragraph num="(iii)"> <text>On any of the measures in §B(3)(f) of this regulation for which the MCO does not meet the minimum target, as determined by the Department, a penalty of 1/10 of 1 percent of the total capitation amount paid to the MCO during the measurement year shall be collected if the conditions in §B(3)(h)(iv) of this regulation do not apply;</text> </paragraph> <paragraph num="(iv)"> <text>If the Department’s actuary determines that the MCO’s total capitation amount for the measurement year does not meet the actuarial soundness definition described in 42 CFR §438.4 after collection of the total penalty amount described in §B(3)(h)(iii) of this regulation, the Department’s actuary shall calculate the maximum penalty the Department shall apply that results in the MCO’s total capitation for the measurement year remaining actuarially sound;</text> </paragraph> <paragraph num="(v)"> <text>If the MCO’s penalty amount is reduced as described in §B(3)(h)(iv) of this regulation, the Department may impose any of the additional sanctions described in COMAR 10.67.10;</text> </paragraph> <paragraph num="(vi)"> <text>The total amount of the penalties as described in §B(3)(h)(iii) of this regulation may not exceed 1 percent of the total capitation amount paid to the MCO during the same measurement year;</text> </paragraph> <paragraph num="(vii)"> <text>On any of the measures in §B(3)(f) of this regulation for which the MCO meets or exceeds the incentive target, as determined by the Department, the MCO shall be paid an incentive payment of up to 1/10 of 1 percent of the total capitation paid to the MCO during that measurement year;</text> </paragraph> <paragraph num="(viii)"> <text>The total amount of the incentive payments as described in §B(3)(h)(vii) of this regulation shall be paid to the MCOs with total amount of the penalties as described in §B(3)(h)(iii) of this regulation collected from the MCOs in that same year, plus additional reserves in the HealthChoice Performance Incentive Fund if the total amount of the penalties collected is insufficient to pay the total amount of the incentive payments;</text> </paragraph> <paragraph num="(ix)"> <text>40 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be distributed to the MCOs earning net incentives with the four highest normalized scores, at a rate calculated by multiplying each MCO’s adjusted enrollment as of December 31 of the measurement year by a per-enrollee amount;</text> </paragraph> <paragraph num="(x)"> <text>MCOs earning net disincentives are ineligible to receive the funds described in §B(3)(h)(ix) of this regulation;</text> </paragraph> <paragraph num="(xi)"> <text>25 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be distributed to the MCOs that the Department determines have demonstrated performance improvement in the measurement year, provided that the MCOs use the funding to target performance improvement in areas defined by the Department;</text> </paragraph> <paragraph num="(xii)"> <text>25 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be retained for health improvement programs under the Maryland Medicaid Managed Care Program;</text> </paragraph> <paragraph num="(xiii)"> <text>10 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be used to establish a reserve in the HealthChoice Performance Incentive Fund, to be used in any calendar year when the amount of penalties collected is insufficient to pay incentives earned by MCOs; and</text> </paragraph> <paragraph num="(xiv)"> <text>If the amount in the HealthChoice Performance Incentive Fund exceeds $5,000,000, the Department shall equally allocate the remaining 10 percent of funds for use in §B(3)(h)(ix)—(xii);</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>The adjusted enrollment amount in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation shall be calculated by:</text> <paragraph num="(i)"> <text>Multiplying four times the enrollment of the MCO with the highest normalized score;</text> </paragraph> <paragraph num="(ii)"> <text>Multiplying three times the enrollment of the MCO with the second highest normalized score;</text> </paragraph> <paragraph num="(iii)"> <text>Multiplying two times the enrollment of the MCO with the third highest normalized score; and</text> </paragraph> <paragraph num="(iv)"> <text>Using the actual enrollment of the MCO with the fourth highest normalized score;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>The per enrollee amount in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation shall be calculated by dividing the sum of the calculations in §B(3)(i)(i)—(iv) of this regulation into the funds remaining as described in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation; and</text> </paragraph> <paragraph num="(k)"> <text>The methodology described in §B(3)(a)—(j) of this regulation shall remain in effect through December 31, 2021;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An annual enrollee satisfaction survey using the latest version of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey tool, conducted by an NCQA-certified CAHPS vendor;</text> </paragraph> <paragraph num="(5)"> <text>An annual Maryland Healthy Kids audit in order to determine the quality of the clinical care provided to all children younger than 21 years old enrolled in the HealthChoice Program as follows:</text> <paragraph num="(a)"> <text>The audit shall include a review of a sample of medical records from each provider reviewed during the calendar year to assess clinical care;</text> </paragraph> <paragraph num="(b)"> <text>The results of the audit that are below minimum EPSDT standards may result in corrective action required by both the provider and the MCO; and</text> </paragraph> <paragraph num="(c)"> <text>The Department shall issue a final report of the audit results;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Performance improvement projects to be conducted by the MCOs that focus on clinical or nonclinical areas as determined by the Department or CMS and include the following:</text> <paragraph num="(a)"> <text>Measurement of performance using objective quality indicators;</text> </paragraph> <paragraph num="(b)"> <text>Implementation of system interventions to achieve improvement in quality;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of effectiveness of interventions;</text> </paragraph> <paragraph num="(d)"> <text>Planning and initiation of activities to sustain improvement; and</text> </paragraph> <paragraph num="(e)"> <text>Reporting of results to the Department or CMS; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Validation and evaluation of MCO provider networks to ensure compliance with the network adequacy and access standards set forth in COMAR 10.67.05.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an MCO is assessed as deficient in accordance with federal and State standards, the MCO shall submit a plan of corrective action to the Department.</text> </paragraph> <paragraph num="D."> <text>An MCO shall provide the Department a copy of its most recent NCQA accreditation, including:</text> <paragraph num="(1)"> <text>Accreditation status, survey type, and level;</text> </paragraph> <paragraph num="(2)"> <text>Accreditation results, including:</text> <paragraph num="(a)"> <text>Recommended actions or improvements;</text> </paragraph> <paragraph num="(b)"> <text>Corrective action plans; and</text> </paragraph> <paragraph num="(c)"> <text>Summaries of findings; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Expiration date of the accreditation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="HealthChoice Health Equity Incentive Program."> <paragraph num="A."> <text>The Department shall award a defined amount of funding annually to MCOs based on the county of residence of their members and the socioeconomic disadvantage index described in this regulation.</text> </paragraph> <paragraph num="B."> <text>Socioeconomic Disadvantage Index.</text> <paragraph num="(1)"> <text>The Department shall calculate a ranking for each service area in Maryland in accordance with the following domains:</text> <paragraph num="(a)"> <text>Community safety;</text> </paragraph> <paragraph num="(b)"> <text>Food security;</text> </paragraph> <paragraph num="(c)"> <text>Housing security; and</text> </paragraph> <paragraph num="(d)"> <text>Transportation access.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall select component measures and calculate rankings that aggregate to the domains defined in §B of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>Rankings shall range from first to twenty-fourth, with first being the lowest ranking for socioeconomic disadvantage and twenty-fourth being the highest ranking for socioeconomic disadvantage.</text> </paragraph> <paragraph num="(4)"> <text>Each service area shall be assigned a single summary score by calculating the equal-weighted average across each service area’s domain rankings.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall award available equity funding to MCOs serving members in Maryland service areas based on the following criteria:</text> <paragraph num="(1)"> <text>Allocation of equity funding shall be made proportionally to the MCO’s membership in the service areas at the top quartile of the socioeconomic disadvantage index.</text> </paragraph> <paragraph num="(2)"> <text>Funding for each calendar year shall be determined based on available funding in the Department’s budget and specified in the annual HealthChoice Managed Care Organization Agreement.</text> </paragraph> <paragraph num="(3)"> <text>The annual allocation for HealthChoice Health Equity Incentive Program shall be funded outside of managed care capitation rates.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Incentive funds awarded under the HealthChoice Health Equity Incentive Program are not appealable under 10.67.10.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-2" heading="HealthChoice Population Health Incentive Program (PHIP)."> <paragraph num="A."> <text>Effective January 1, 2022, the Department shall establish the HealthChoice Population Health Incentive Program (PHIP).</text> </paragraph> <paragraph num="B."> <text>An MCO may be eligible for an incentive payment for the following performance measures:</text> <paragraph num="(1)"> <text>Ambulatory care visits for Supplemental Security Income (SSI) adults;</text> </paragraph> <paragraph num="(2)"> <text>Ambulatory care visits for Supplemental Security Income (SSI) children;</text> </paragraph> <paragraph num="(3)"> <text>HEDIS asthma medication ratio;</text> </paragraph> <paragraph num="(4)"> <text>Hemoglobin A1c control for patients with diabetes — poor control (>9.0%);</text> </paragraph> <paragraph num="(5)"> <text>Lead screening measures:</text> <paragraph num="(a)"> <text>Lead screening measure for children 1223 months old; and</text> </paragraph> <paragraph num="(b)"> <text>HEDIS lead screening in children;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>HEDIS postpartum care;</text> </paragraph> <paragraph num="(7)"> <text>HEDIS risk of continued opioid use >=31 days covered; and</text> </paragraph> <paragraph num="(8)"> <text>HEDIS timeliness of prenatal care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Each measure identified in §B of this regulation shall be valued equally at a proportional share of available incentive funds, except for measures §B(5)(a) and (b), which are each valued at half of the available incentive funds relative to one of the other measures.</text> </paragraph> <paragraph num="D."> <text>There shall be two rounds of potential incentive payments an MCO may earn.</text> </paragraph> <paragraph num="E."> <text>Subject to budget approval, total PHIP funding shall be determined prior to the measurement year and included in the MCO contract.</text> </paragraph> <paragraph num="F."> <text>All PHIP payments shall be funded independently from and outside of MCO capitation payments during a given calendar year.</text> </paragraph> <paragraph num="G."> <text>Each MCO shall be eligible for no more than 1 percent of the plan's measurement year capitation payments, excluding supplemental payments outside of capitation, as total payment from round one and round two.</text> </paragraph> <paragraph num="H."> <text>If the Department determines that the score for any measure identified in §B of this regulation may not be comparable to the previous year's score due to alterations in measure specifications or other factors, the Department may exclude the measure from the PHIP and adjust the incentive valuation in accordance with the remaining performance measures.</text> </paragraph> <paragraph num="I."> <text>Round One Incentives.</text> <paragraph num="(1)"> <text>An MCO may earn two types of incentives in round one:</text> <paragraph num="(a)"> <text>A performance incentive payment; and</text> </paragraph> <paragraph num="(b)"> <text>An improvement incentive payment.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If an MCO does not report a performance measure or an MCO has a performance score of 0 percent, then the MCO is awarded no performance or improvement incentive payments for this measure.</text> </paragraph> <paragraph num="(3)"> <text>Performance Incentive Payments for Round One.</text> <paragraph num="(a)"> <text>Performance incentive payments shall be based on the following categories for each performance measure:</text> <paragraph num="(i)"> <text>Superlative performance, meaning the performance measure's score is at or above the 90th percentile of HEDIS Medicaid performance nationwide during the measurement year, or estimated 90th percentile among Maryland HealthChoice MCO performance for non-HEDIS performance measures;</text> </paragraph> <paragraph num="(ii)"> <text>Very strong performance, meaning the performance measure's score is between the 75th and 89th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 75th and 89th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures; or</text> </paragraph> <paragraph num="(iii)"> <text>Strong performance, meaning the performance measure's score is between the 50th and 74th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 50th and 74th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Payments for round one performance incentives shall be allocated as follows:</text> <paragraph num="(i)"> <text>For superlative performance, an MCO may earn 100 percent of the incentive allocation for the performance measure;</text> </paragraph> <paragraph num="(ii)"> <text>For very strong performance, an MCO may earn 66.6 percent of the incentive allocation for the performance measure;</text> </paragraph> <paragraph num="(iii)"> <text>For strong performance, an MCO may earn 33.3 percent of the incentive allocation for the performance measure; and</text> </paragraph> <paragraph num="(iv)"> <text>Any MCO earning a performance measure score below the 50th percentile of HEDIS Medicaid performance nationwide during the measurement year on a HEDIS-based measure, or below the calculated 50th percentile among Maryland HealthChoice MCO performance for a non-HEDIS measure, shall be ineligible for a round one performance incentive payment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Round One Improvement Incentive Payments.</text> <paragraph num="(a)"> <text>An MCO may earn an improvement incentive payment of 33.3 percent of the incentive allocation for any performance measure if the following conditions are met:</text> <paragraph num="(i)"> <text>The MCO demonstrates improvement of at least 0.5 percentage points in the measure compared to the previous measurement year; and</text> </paragraph> <paragraph num="(ii)"> <text>The performance measure score is at or above the 50th percentile of HEDIS Medicaid performance nationwide on a HEDIS-based measure, or the 50th percentile of Maryland HealthChoice MCO performance for a non-HEDIS measure.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An MCO earning a superlative performance incentive payment for a performance measure is ineligible for an improvement incentive payment for the same measure.</text> </paragraph> <paragraph num="(c)"> <text>For any performance measures in which a lower score indicates stronger performance, year-over-year improvement is demonstrated by a reduction in the score for that measure.</text> </paragraph> <paragraph num="(d)"> <text>If an MCO is missing or zero-valued for a performance measure in the previous year, then no improvement incentive will be awarded in the measurement year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>Round Two Incentive Payments.</text> <paragraph num="(1)"> <text>An MCO may qualify for payments under round two if the following conditions are met:</text> <paragraph num="(a)"> <text>The MCO earned above 80 percent of possible round one incentives; and</text> </paragraph> <paragraph num="(b)"> <text>The MCO did not have penalties applied during the measurement year for failure to meet the HEDIS MCO Performance Monitoring Policy included in the MCO contract.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Any remaining funds that were unallocated during round one may be awarded to eligible MCOs in round two for a maximum incentive award of up to 1 percent of its total capitation payment during the PHIP measurement year, excluding supplemental payments outside of capitation.</text> </paragraph> <paragraph num="(3)"> <text>If any remaining funds that were unallocated during round one are not sufficient to settle all qualifying MCOs up to 1 percent of capitation in round two, then the leftover funds will be awarded proportionally among qualifying MCOs based on enrollment.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If additional funds remain after both round one and round two, the Department may, within its discretion, allocate the funding as follows:</text> <paragraph num="(1)"> <text>Make additional payments to MCOs that are below 1 percent of capitation based on improvement or performance; or</text> </paragraph> <paragraph num="(2)"> <text>Place remaining funds into a nonlapsing pool.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Effective measurement year 2025, an MCO with penalties under the HEDIS MCO Performance Monitoring Policy included in the HealthChoice MCO Agreement shall be excluded from all rounds of PHIP for that measurement year.</text> </paragraph> <paragraph num="M."> <text>Incentives awarded under this regulation and exclusion from PHIP participation are not appealable under COMAR 10.67.10..</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Special Needs Populations."> <paragraph num="A."> <text>An MCO shall provide health care services to enrollees who are members of special needs populations.</text> </paragraph> <paragraph num="B."> <text>Special needs populations consist of the following non-mutually exclusive populations:</text> <paragraph num="(1)"> <text>Children with special health care needs;</text> </paragraph> <paragraph num="(2)"> <text>Individuals with a physical disability;</text> </paragraph> <paragraph num="(3)"> <text>Individuals with a developmental disability;</text> </paragraph> <paragraph num="(4)"> <text>Pregnant and postpartum women;</text> </paragraph> <paragraph num="(5)"> <text>Individuals who are homeless;</text> </paragraph> <paragraph num="(6)"> <text>Individuals with HIV/AIDS; and</text> </paragraph> <paragraph num="(7)"> <text>Children in State-supervised care.</text> </paragraph> </paragraph> <paragraph num="C."> <text>General Requirements for Special Needs Populations.</text> <paragraph num="(1)"> <text>An MCO shall demonstrate that its pediatric and adult primary care providers (PCPs) and specialists are clinically qualified based upon generally accepted community standards to provide or arrange for the provision of appropriate health care services to individuals who are members of a special needs population. The MCO shall submit to the Department referral protocols that demonstrate the conditions under which PCPs will make the arrangements for referrals to specialty care networks.</text> </paragraph> <paragraph num="(2)"> <text>Clinical qualifications are to be determined through the MCO's credentialing and recredentialing processes, including a review of the provider's medical education, special training, and work history and experience.</text> </paragraph> <paragraph num="(3)"> <text>Specialty and subspecialty providers shall:</text> <paragraph num="(a)"> <text>Have experience in treating individuals within a special needs population;</text> </paragraph> <paragraph num="(b)"> <text>Have experience in interdisciplinary medical management; and</text> </paragraph> <paragraph num="(c)"> <text>Understand the relationship between somatic and behavioral health care issues and interventions.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The MCO shall demonstrate the use of a primary care system of care delivery which includes a comprehensive plan of care for an enrollee who is a member of a special needs population and which uses a coordinated and continuous case management approach, involving the enrollee and, as appropriate, the enrollee's family, guardian, or caregiver, in all aspects of care, including primary, acute, tertiary, and home care.</text> </paragraph> <paragraph num="(5)"> <text>To meet the commitment outlined in §C(4) of this regulation, an MCO shall:</text> <paragraph num="(a)"> <text>Provide case management services to adult and pediatric enrollees as appropriate;</text> </paragraph> <paragraph num="(b)"> <text>Have the capacity to perform home visits as part of the ongoing case management program and have the ability to respond to urgent care needs while in the enrollee's home;</text> </paragraph> <paragraph num="(c)"> <text>Ensure that, if warranted, a case manager is assigned to an enrollee at the time of the initial health screen by the MCO;</text> </paragraph> <paragraph num="(d)"> <text>Ensure that the PCP, who may also be the specialist, shall be the admitting or referring provider for all hospital admissions;</text> </paragraph> <paragraph num="(e)"> <text>Ensure that it will:</text> <paragraph num="(i)"> <text>Collaborate with inpatient facilities in facilitating preadmission and discharge planning, and</text> </paragraph> <paragraph num="(ii)"> <text>Communicate all post-discharge home and community arrangements to the enrollee, the PCP, and, as appropriate, the enrollee's family, guardian, and caregiver;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Document the plan of care and treatment modalities provided to enrollees in special populations, assuring that the plan of care:</text> <paragraph num="(i)"> <text>Is updated at least annually, when the enrollee’s circumstances or needs change significantly, or at the enrollee’s request; and</text> </paragraph> <paragraph num="(ii)"> <text>Involves the enrollee and, as appropriate, the enrollee's family, guardian, and caregiver in care decisions; and</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Be familiar with community and social support providers for the special populations.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An MCO shall make documented outreach efforts to contact and educate enrollees who fail to appear for appointments or who have been noncompliant with a regimen of care. These efforts may include, but may not be limited to, notification:</text> <paragraph num="(a)"> <text>By mail;</text> </paragraph> <paragraph num="(b)"> <text>By telephone;</text> </paragraph> <paragraph num="(c)"> <text>By email;</text> </paragraph> <paragraph num="(d)"> <text>By text messaging; and</text> </paragraph> <paragraph num="(e)"> <text>Through face-to-face contact.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Referral to Local Health Department.</text> <paragraph num="(a)"> <text>An MCO shall make a written referral, or ensure that the enrollee's provider makes a written referral, to the local health department (LHD) for the county in which an enrollee resides, for assistance in bringing into care an enrollee for whom the MCO has been unsuccessful in its documented out-reach efforts pursuant to §C(6) of this regulation, within 10 business days of whichever first occurs:</text> <paragraph num="(i)"> <text>The third consecutive missed appointment; or</text> </paragraph> <paragraph num="(ii)"> <text>The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The MCO may not include information about an enrollee's HIV status on the form used to refer an enrollee to the local health department.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>An MCO shall subject its decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested, for an enrollee who is a member of special needs population to utilization review that includes review by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease.</text> </paragraph> <paragraph num="(9)"> <text>An MCO shall identify a special needs coordinator, who shall:</text> <paragraph num="(a)"> <text>Serve as a point of contact for health care services information and referral for members of special needs populations;</text> </paragraph> <paragraph num="(b)"> <text>Be skilled in communications with, and sensitive to the unique needs of, members of special needs populations, their families, guardians, and caregivers;</text> </paragraph> <paragraph num="(c)"> <text>Participate on the MCO's consumer advisory board, pursuant to Regulation .12 of this chapter, as a representative of special needs populations;</text> </paragraph> <paragraph num="(d)"> <text>Serve as a resource to MCO providers and enrollees on the requirements of P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; and</text> </paragraph> <paragraph num="(e)"> <text>Maintain a log of each denial of treatment and the outcome of the utilization review conducted pursuant to §C(8) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>An MCO shall have mechanisms in place to allow enrollees with special health care needs to access a specialist directly as appropriate for the enrollee’s condition and identified needs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Special Needs Populations — Children with Special Health Care Needs."> <paragraph num="A."> <text>An MCO shall meet the standards set forth in this regulation for treating children with special health care needs.</text> </paragraph> <paragraph num="B."> <text>The Department shall maintain a record of the complaints received through the Department's enrollee and provider hotlines which involve the denial of care for children and review these complaint logs as part of its quality assurance system.</text> </paragraph> <paragraph num="C."> <text>An MCO shall demonstrate that its therapies provider network is adequate by demonstrating its:</text> <paragraph num="(1)"> <text>Providers' pediatric specialties;</text> </paragraph> <paragraph num="(2)"> <text>Collaboration with schools that provide IEP or IFSP services to its enrollees, where available; and</text> </paragraph> <paragraph num="(3)"> <text>Provision of family-focused services and development of family-focused plans of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO shall provide case management services to children with special health care needs as appropriate. For complex cases involving multiple medical interventions or social services, or both, a multidisciplinary team shall be used to review and develop the plan of care for special health care needs children.</text> </paragraph> <paragraph num="E."> <text>An MCO shall provide coordinated care for special health care needs children in State-supervised care.</text> </paragraph> <paragraph num="F."> <text>An MCO shall refer child victims of alleged abuse, neglect, or sexual offense to an appropriate provider capable of:</text> <paragraph num="(1)"> <text>Determining if the alleged abuse, neglect, or sexual offense occurred;</text> </paragraph> <paragraph num="(2)"> <text>Determining if medical intervention is needed; and</text> </paragraph> <paragraph num="(3)"> <text>Ensuring the preservation of evidence.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An MCO shall ensure coordination with the Department’s Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program.</text> </paragraph> <paragraph num="H."> <text>An MCO shall establish protocols for effecting medically necessary service referrals to specialty care providers for children with special health care needs.</text> </paragraph> <paragraph num="I."> <text>The service referrals referenced in §H of this regulation shall:</text> <paragraph num="(1)"> <text>Include services intended to improve or preserve the continuing health and quality of life for children with special health care needs, regardless of the ability of the services to effect permanent cure; and</text> </paragraph> <paragraph num="(2)"> <text>Be made when the child is:</text> <paragraph num="(a)"> <text>Identified as being at risk of a developmental delay by the developmental screen required by EPSDT;</text> </paragraph> <paragraph num="(b)"> <text>Experiencing a delay of 25 percent or more in any developmental area as measured by appropriate diagnostic instruments and procedures;</text> </paragraph> <paragraph num="(c)"> <text>Manifesting atypical development or behavior; or</text> </paragraph> <paragraph num="(d)"> <text>Diagnosed with a physical or mental condition that has a high probability of resulting in developmental delay.</text> </paragraph> </paragraph> </paragraph> <paragraph num="J."> <text>An MCO shall provide durable medical equipment to a special needs child in a timely manner.</text> </paragraph> <paragraph num="K."> <text>When a child, who is an MCO enrollee, is diagnosed with a special health care need requiring a plan of care which includes specialty services, and that health care need was undiagnosed at the time of enrollment, the parent or guardian of that child may request approval from the MCO for a specific out-of-network specialty provider to provide those services when the MCO does not have a local in-network specialty provider with the same professional training and expertise who is reasonably available and provides the same service and modality, subject to the following provisions:</text> <paragraph num="(1)"> <text>If the MCO denies the request for an out-of-network provider referral, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05;</text> </paragraph> <paragraph num="(2)"> <text>If at any time the MCO decides to terminate or reduce services provided by the approved out-of-network provider, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05;</text> </paragraph> <paragraph num="(3)"> <text>The MCO shall continue to cover the services of the out-of-network provider during the course of the appeal until such time as the Office of Administrative Hearings issues its decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Special Needs Populations — Individuals with a Physical Disability."> <paragraph num="A."> <text>An MCO shall meet the standards set forth in this regulation for treating an individual with a physical disability.</text> </paragraph> <paragraph num="B."> <text>An MCO shall demonstrate that its providers for durable medical equipment and assistive technology provide the appropriate services and are clinically qualified to provide these services to the individual with a physical disability.</text> </paragraph> <paragraph num="C."> <text>Before placement of an individual with a physical disability into an intermediate or long-term care facility, an MCO shall:</text> <paragraph num="(1)"> <text>Recommend that an individual with a physical disability be transferred to an intermediate or long-term care facility only after assessing the needs of the individual and the ability of the MCO to meet these needs in the community as supplemented by other Medicaid services;</text> </paragraph> <paragraph num="(2)"> <text>Conduct a second opinion review of the case, performed by the MCO's medical director, before a transfer to an intermediate care facility or a long-term care facility is implemented; and</text> </paragraph> <paragraph num="(3)"> <text>If the MCO's medical director determines that the transfer to an intermediate or long- term care facility is medically necessary and that the expected stay will be greater than 30 days, obtain approval from the Department before making the transfer.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with a physical disability.</text> </paragraph> <paragraph num="E."> <text>An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with physical disabilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Special Needs Populations — Individuals with a Developmental Disability."> <paragraph num="A."> <text>An MCO shall meet the standards set forth in this regulation for treating an individual with a developmental disability.</text> </paragraph> <paragraph num="B."> <text>An MCO shall ensure that its case managers have experience or training related to developmental disabilities.</text> </paragraph> <paragraph num="C."> <text>An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with developmental disabilities.</text> </paragraph> <paragraph num="D."> <text>An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with developmental disabilities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Special Needs Populations — Pregnant and Postpartum Women."> <paragraph num="A."> <text>An MCO shall meet the standards set forth in this regulation for treating pregnant and postpartum women.</text> </paragraph> <paragraph num="B."> <text>An MCO shall ensure access to prenatal care for pregnant women and postpartum care for postpartum women by:</text> <paragraph num="(1)"> <text>Scheduling an appointment for the first prenatal visit and seeing the woman within 10 days of request;</text> </paragraph> <paragraph num="(2)"> <text>Scheduling an appointment for a postpartum woman and seeing the woman within 10 days of request:</text> </paragraph> <paragraph num="(3)"> <text>Arranging for an adequate network of providers including obstetricians, gynecologists, perinatologists, neonatologists, anesthesiologists, and advanced practice nurses who are capable of addressing complex maternal and infant health issues; and</text> </paragraph> <paragraph num="(4)"> <text>Linking a pregnant woman with a pediatric provider before delivery.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall ensure that prenatal providers:</text> <paragraph num="(1)"> <text>Complete a prenatal risk assessment, using an instrument approved by the Department, at the first prenatal visit; and</text> </paragraph> <paragraph num="(2)"> <text>Within 10 days of completing the prenatal risk assessment, forward this instrument to the local health department in the jurisdiction in which the pregnant enrollee lives.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The Department may not include questions about a woman's HIV infection status on the prenatal risk assessment instrument.</text> </paragraph> <paragraph num="E."> <text>An MCO shall refer pregnant and postpartum women with a substance use disorder to the behavioral health ASO for substance use treatment within 24 hours of request.</text> </paragraph> <paragraph num="F."> <text>An MCO shall refer pregnant and postpartum women, infants, and children younger than 5 years old to the WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) Program, and shall provide to WIC necessary medical information to determine WIC nutritional eligibility.</text> </paragraph> <paragraph num="G."> <text>An MCO shall follow, at a minimum, the American College of Obstetricians and Gynecologists (ACOG) guidelines for pregnant and postpartum women.</text> </paragraph> <paragraph num="H."> <text>An MCO shall provide risk-related medical and nonmedical preventive treatment services, including nutrition counseling by licensed nutritionists or dietitians and smoking cessation education and treatment for pregnant and postpartum women.</text> </paragraph> <paragraph num="I."> <text>An MCO shall provide HIV counseling, including a risk assessment and information about possible transmission of HIV to the fetus.</text> </paragraph> <paragraph num="J."> <text>An MCO shall offer its pregnant and postpartum enrollees voluntary HIV counseling and testing following the requirements of COMAR 10.67.06.</text> </paragraph> <paragraph num="K."> <text>An MCO shall arrange for the appropriate emergency transfer of pregnant women, newborns, and infants to tertiary care centers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Special Needs Populations — Homeless Individuals."> <text>An MCO's initial health screen shall attempt to identify homeless individuals and link them to the appropriate provider of services.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Special Needs Populations — Individuals with HIV/AIDS."> <paragraph num="A."> <text>An MCO shall meet the standards set forth in this regulation for treating individuals with HIV/AIDS.</text> </paragraph> <paragraph num="B."> <text>HIV/AIDS Specialist.</text> <paragraph num="(1)"> <text>An MCO shall allow an enrollee with HIV/AIDS to choose an HIV/AIDS specialist for treatment and coordination of primary and specialty care.</text> </paragraph> <paragraph num="(2)"> <text>To qualify as an HIV/AIDS specialist, a health care provider shall be board certified in the field of infectious diseases by a member board of the American Board of Medical Specialties or:</text> <paragraph num="(a)"> <text>Hold a current, valid, unrevoked, and unsuspended Maryland license or certification as a:</text> <paragraph num="(i)"> <text>Doctor of medicine;</text> </paragraph> <paragraph num="(ii)"> <text>Doctor of osteopathy;</text> </paragraph> <paragraph num="(iii)"> <text>Nurse practitioner; or</text> </paragraph> <paragraph num="(iv)"> <text>Physician's assistant being supervised by a medical doctor;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Have provided direct, continuous, ongoing care for at least 20 patients with HIV over the past 2 years; and</text> </paragraph> <paragraph num="(c)"> <text>Have completed one of the following requirements:</text> <paragraph num="(i)"> <text>If a medical doctor, certified physician's assistant being supervised by a medical doctor, or doctor of osteopathy, at least 30 hours of HIV-related continuing medical education category I credits over the past 2 years;</text> </paragraph> <paragraph num="(ii)"> <text>If a nurse practitioner, at least 30 hours of HIV-related continuing education units over the past 2 years;</text> </paragraph> <paragraph num="(iii)"> <text>If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, an accredited training program over the past year; or</text> </paragraph> <paragraph num="(iv)"> <text>If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, has completed the American Academy of HIV Medicine (AAHIVM) credentialing examination.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>AIDS Case Management Services.</text> <paragraph num="(1)"> <text>An MCO shall ensure that an enrollee with HIV/AIDS receives case management services that:</text> <paragraph num="(a)"> <text>Link the enrollee with the full range of available benefits;</text> </paragraph> <paragraph num="(b)"> <text>Link the enrollee with any additional needed services including:</text> <paragraph num="(i)"> <text>Mental health services;</text> </paragraph> <paragraph num="(ii)"> <text>Substance abuse services;</text> </paragraph> <paragraph num="(iii)"> <text>Medical services;</text> </paragraph> <paragraph num="(iv)"> <text>Social services;</text> </paragraph> <paragraph num="(v)"> <text>Financial services;</text> </paragraph> <paragraph num="(vi)"> <text>Counseling services;</text> </paragraph> <paragraph num="(vii)"> <text>Educational services;</text> </paragraph> <paragraph num="(viii)"> <text>Housing services; and</text> </paragraph> <paragraph num="(ix)"> <text>Other required support services;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Ensure timely and coordinated access to medically necessary levels of care that support continuity of care across the continuum of service providers;</text> </paragraph> <paragraph num="(d)"> <text>Are performed by licensed physicians, physician assistants, advanced practice nurses, registered nurses, social workers, or other individuals who are appropriately trained, experienced, and supervised by a licensed practitioner; and</text> </paragraph> <paragraph num="(e)"> <text>Include, but are not limited to:</text> <paragraph num="(i)"> <text>Initial and ongoing assessment of the enrollee's needs and personal support systems, including the MCO offering an enrollee one face-to-face meeting during the initial assessment and documenting the enrollee's acceptance or declination of the face to face meeting;</text> </paragraph> <paragraph num="(ii)"> <text>Development of a comprehensive, individualized service plan, using a multidisciplinary approach;</text> </paragraph> <paragraph num="(iii)"> <text>Coordination of the services required to implement the plan;</text> </paragraph> <paragraph num="(iv)"> <text>Periodic reevaluation and adaptation of the plan as necessary over the life of the enrollee;</text> </paragraph> <paragraph num="(v)"> <text>Development of an outreach system for the enrollee and family by which the case manager and primary care provider track services received, clinical outcomes, and the need for additional follow-up; and</text> </paragraph> <paragraph num="(vi)"> <text>Serving as an effective enrollee advocate to resolve differences between the enrollee and providers of care pertaining to the course or content of therapeutic interventions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An enrollee diagnosed with HIV/AIDS shall be offered case management services by the MCO at any time after diagnosis. An enrollee who has previously refused these services may request case management from the MCO at any time.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Diagnostic Evaluation Service (DES) Assessment.</text> <paragraph num="(1)"> <text>An MCO shall offer a diagnostic evaluation service (DES) assessment annually and document the enrollee's acceptance or declination.</text> </paragraph> <paragraph num="(2)"> <text>The DES shall consist of a comprehensive medical and psychosocial assessment.</text> </paragraph> <paragraph num="(3)"> <text>A DES provider shall use assessment and care plan forms used by the Department for adult and pediatric assessments.</text> </paragraph> <paragraph num="(4)"> <text>An individual shall select a DES provider from an approved list of sites, and may select a DES provider which is not part of the individual's MCO if so desired.</text> </paragraph> <paragraph num="(5)"> <text>An MCO and other qualified institutions may become DES providers as provided in COMAR 10.09.32.03C.</text> </paragraph> </paragraph> <paragraph num="E."> <text>An individual with HIV/AIDS who has a substance use disorder shall be referred to the behavioral health ASO for substance abuse treatment within 24 hours of request.</text> </paragraph> <paragraph num="F."> <text>Clinical Trials.</text> <paragraph num="(1)"> <text>An MCO may refer enrollees who are individuals with HIV/AIDS to facilities or organizations that can provide the enrollees' access to clinical trials.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall provide enrollees with HIV/AIDS access to clinical trials in accordance with COMAR 10.67.06.26-1.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Special Needs Populations — Individuals in Need of Substance Abuse Treatment — Repealed" /> <regulation prefix="Regulation" num=".12" heading="Consumer Advisory Board."> <paragraph num="A."> <text>An MCO shall establish a consumer advisory board to facilitate the receipt of input from enrollees.</text> </paragraph> <paragraph num="B."> <text>The consumer advisory board membership shall:</text> <paragraph num="(1)"> <text>Consist of enrollees and enrollees' family members, guardians, or caregivers; and</text> </paragraph> <paragraph num="(2)"> <text>Be comprised of no less than one third representation from the MCO’s special needs populations, or their representatives and the MCO’s special needs coordinator.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The consumer advisory board shall meet at least 6 times a year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Children in State-Supervised Care."> <paragraph num="A."> <text>An MCO shall provide or arrange to provide all Medicaid-covered services required to comply with State statutes and regulations mandating health and mental health services for children in State-supervised care.</text> </paragraph> <paragraph num="B."> <text>An MCO shall ensure the continuity and coordination of care, provided locally to the extent the services are available, to an enrollee who is a child in State-supervised care.</text> </paragraph> <paragraph num="C."> <text>An enrollee who is a child in State-supervised care who moves shall be disenrolled from the recipient's MCO and enrolled in an alternative MCO if the recipient's current MCO does not serve the geographic region to which the child has been relocated.</text> </paragraph> <paragraph num="D."> <text>An MCO shall expedite a change of providers within its provider panel upon the move of an enrollee who is a child in State-supervised care to a new geographic area served by the MCO.</text> </paragraph> <paragraph num="E."> <text>On request of the responsible State or local agency, a child in State-supervised care may be disenrolled from the current MCO and enrolled in an MCO serving the group facility in which the child resides, members of the foster care family, or other children in foster care placement with the child.</text> </paragraph> <paragraph num="F."> <text>Enrollee Self-Referral. An MCO shall permit the self-referral of a child in State-supervised care to an EPSDT certified provider for an initial examination, including a mental health screen, and shall pay for all portions of the examination except for the mental health screen, which shall be paid for by the Specialty Mental Health System.</text> </paragraph> <paragraph num="G."> <text>Coordination with Responsible Agency. An MCO shall appoint a liaison to coordinate services to a child in State-supervised care with the responsible State or local agencies.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Referral to Behavioral Health ASO."> <paragraph num="A."> <text>An MCO is responsible for providing medically necessary primary behavioral health services to their enrollees.</text> </paragraph> <paragraph num="B."> <text>An enrollee may self-refer to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80.</text> </paragraph> <paragraph num="C."> <text>If an enrollee’s primary care physician determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the primary care physician shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80.</text> </paragraph> <paragraph num="D."> <text>If an MCO determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the MCO shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80.</text> </paragraph> <paragraph num="E."> <text>An MCO shall cooperate with the behavioral health ASO in developing referral procedures and protocols.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Data Collection and Reporting."> <paragraph num="A."> <text>An MCO shall notify the Department immediately when it has knowledge of an enrollee's death.</text> </paragraph> <paragraph num="B."> <text>Encounter Data.</text> <paragraph num="(1)"> <text>An MCO shall submit encounter data reflecting 100 percent of provider-enrollee encounters, in CMS1500 and UB04 format or an alternative format previously approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>An MCO may use alternative formats including:</text> <paragraph num="(a)"> <text>ASC X12N 837 and NCPDP formats; and</text> </paragraph> <paragraph num="(b)"> <text>ASC X12N 835 format, as appropriate.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An MCO shall submit encounter data that identifies the provider who delivers any items or services to enrollees at a frequency and level of detail to be specified by CMS and the Department, including, at a minimum:</text> <paragraph num="(a)"> <text>Enrollee and provider identifying information;</text> </paragraph> <paragraph num="(b)"> <text>Service, procedure, and diagnoses codes;</text> </paragraph> <paragraph num="(c)"> <text>Allowed, paid, enrollee responsibility, and third-party liability amounts; and</text> </paragraph> <paragraph num="(d)"> <text>Service, claims submission, adjudication, and payment dates.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An MCO shall report encounter data within 60 calendar days after receipt of the claim from the provider.</text> </paragraph> <paragraph num="(5)"> <text>An MCO shall submit encounter data utilizing a secure on-line data transfer system.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Monthly Reports.</text> <paragraph num="(1)"> <text>An MCO shall provide an updated list of the PCP's assigned enrollees to each PCP at least on a monthly basis.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall participate in the electronic enrollment reconciliation process to identify discrepancies in enrollment data between the Department and the MCO.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Quarterly Reports. An MCO shall submit to the Department:</text> <paragraph num="(1)"> <text>Within 30 calendar days of the close of each calendar quarter, quality assurance reports including, but not limited to:</text> <paragraph num="(a)"> <text>Quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; and</text> </paragraph> <paragraph num="(b)"> <text>An analysis of recipient appeal and grievance logs including significant trends or anomalies, what caused the trend or anomaly, and any actions taken to address the trend or anomaly;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Within 30 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all pre-service denials or reduction of services or benefits issued by the MCO or MCO subcontractors during the preceding quarter.</text> </paragraph> <paragraph num="(3)"> <text>Within 30 calendar days of the close of each calendar quarter, third-party liability collection activities as described in Regulation .18D of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>In a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter.</text> </paragraph> <paragraph num="(5)"> <text>Not later than 45 days after the end of each quarterly rebate period, drug utilization data necessary for the Department to bill manufacturers for rebates in accordance with §1927(b)(1)(A) of the Social Security Act, that:</text> <paragraph num="(a)"> <text>Include, at a minimum, the following information by National Drug Code of each covered outpatient drug dispensed or covered by the MCO:</text> <paragraph num="(i)"> <text>Total number of units of each dosage form;</text> </paragraph> <paragraph num="(ii)"> <text>Total number of units of each dosage strength; and</text> </paragraph> <paragraph num="(iii)"> <text>Total number of units of each dosage package size; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Distinguish utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Within 10 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all State fair hearing outcomes during the preceding quarter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Annual Reports. Except as provided in §E(5) of this regulation, an MCO shall submit to the Department annually, within 90 days after the end of the calendar year:</text> <paragraph num="(1)"> <text>A summary of the information contained in §D(1)(b) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>A report of the MCO's consumer advisory board outlining the board's activities and recommendations;</text> </paragraph> <paragraph num="(3)"> <text>A copy of the MCO's drug formulary;</text> </paragraph> <paragraph num="(4)"> <text>Any revisions to the MCOs quality assurance, utilization management, and case management plans;</text> </paragraph> <paragraph num="(5)"> <text>HealthChoice Financial Monitoring Reports (HFMRs), including any supplemental schedules required by the Department:</text> <paragraph num="(a)"> <text>In the format required by the Department;</text> </paragraph> <paragraph num="(b)"> <text>Prepared according to:</text> <paragraph num="(i)"> <text>The criteria, set forth in Regulation .19-5 of this chapter, for allocating MCO costs to HFMR expense categories; and</text> </paragraph> <paragraph num="(ii)"> <text>Reporting instructions provided by the Department for the HFMR form and any required supplemental schedules; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Submitted according to the following schedule:</text> <paragraph num="(i)"> <text>Services incurred from January 1 through December 31 of the prior year, reported through March 31 of the current year — due on May 15 of the current year; and</text> </paragraph> <paragraph num="(ii)"> <text>Services incurred January 1 through December 31 of the prior year, reported through June 30 of the current year — due on September 1 of the current year; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>A detailed description of its drug utilization program activities.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Unless the MCO is exempt for good cause, an MCO shall submit to the Department when requested the following reports for its enrollee/member services and provider/authorization/preauthorization lines:</text> <paragraph num="(1)"> <text>Caller abandonment rates;</text> </paragraph> <paragraph num="(2)"> <text>Caller service level rates; and</text> </paragraph> <paragraph num="(3)"> <text>Caller average hold time.</text> </paragraph> </paragraph> <paragraph num="G."> <text>If the MCO exits the HealthChoice Program for any reason, including those listed in COMAR 10.67.02.06A(1)(e) and (f):</text> <paragraph num="(1)"> <text>The MCO shall provide the Department with a list of enrollees and the name of each enrollee's PCP, at least 30 days before exiting the program; and</text> </paragraph> <paragraph num="(2)"> <text>On receiving the list provided by the MCO, the Department shall provide the list to:</text> <paragraph num="(a)"> <text>The health benefits exchange to assist and provide outreach to participants in selecting an MCO; and</text> </paragraph> <paragraph num="(b)"> <text>If permitted by State and federal law, the remaining MCOs for linking participants with a PCP.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Jurisdictional Reporting to Local Health Departments. The Department shall:</text> <paragraph num="(1)"> <text>Aggregate by jurisdiction the encounter data it receives from MCOs; and</text> </paragraph> <paragraph num="(2)"> <text>Provide to local health departments jurisdiction-specific information based on aggregated encounter data for public health monitoring and assessment.</text> </paragraph> </paragraph> <paragraph num="I."> <text>For the purposes of Maryland Medicaid Managed Care Program administration or monitoring MCO performance pursuant to this chapter, the MCO shall supply other information as the Department may from time to time request, given a reasonable period of notice.</text> </paragraph> <paragraph num="J."> <text>Nonfederally qualified MCOs shall report a description of certain transactions with parties of interest, as described in §1903(m)(4)(A) of the Social Security Act.</text> </paragraph> <paragraph num="K."> <text>Upon request, an MCO whose member has disenrolled shall transfer historical utilization data to the member's new MCO in the time frame and format specified by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Repealed." /> <regulation prefix="Regulation" num=".17" heading="Subcontractual Relationships."> <paragraph num="A."> <text>Subcontracting Permitted.</text> <paragraph num="(1)"> <text>Consistent with this regulation, an MCO may subcontract services that it is required to provide to its enrollees under COMAR 10.67.06 to a health care provider that is licensed, certified, or otherwise legally authorized to provide those services.</text> </paragraph> <paragraph num="(2)"> <text>An MCO may not discriminate for the participation, reimbursement, or indemnification of any provider who is acting within the scope of the provider's license or certification under applicable State law, solely on the basis of that license or certification.</text> </paragraph> <paragraph num="(3)"> <text>An MCO shall have written agreements with subcontractors that comply with 42 CFR §§438.214 and 455.105, as amended, and include at least the following:</text> <paragraph num="(a)"> <text>A provision that the subcontractor be subject to all of the requirements to which the MCO is subject under its contract with the Department and pursuant to the Department's regulations;</text> </paragraph> <paragraph num="(b)"> <text>A clear description of the services to be performed under the subcontract sufficient to definitively inform the Department which of the MCO's obligations have been subcontracted;</text> </paragraph> <paragraph num="(c)"> <text>A provision for the subcontractor's release to the MCO and to the Department, upon request, of any information necessary for the MCO to perform any of its contractual and regulatory obligations under its contract with the Department, including, but not limited to, its records, reporting, and quality assurance duties;</text> </paragraph> <paragraph num="(d)"> <text>A provision requiring that the subcontractor complies with all State and federal requirements regarding audit, inspection, and evaluation;</text> </paragraph> <paragraph num="(e)"> <text>A provision that copies of the subcontractor's medical records pertaining to the MCO's enrollees shall be furnished to the MCO upon request for transfer to a subsequent provider in the event of a termination of the subcontract;</text> </paragraph> <paragraph num="(f)"> <text>A provision to the effect that no termination of the subcontract shall be effective without prior written notice to the Department;</text> </paragraph> <paragraph num="(g)"> <text>An agreement that the subcontractor will look solely to the MCO for compensation for covered services provided to the MCO's enrollees under the subcontract;</text> </paragraph> <paragraph num="(h)"> <text>An assurance that evidence of the subcontractor's professional liability coverage will be submitted annually to the MCO;</text> </paragraph> <paragraph num="(i)"> <text>A provision that no assignment of the subcontract by the subcontractor is effective without prior written notice to the Department;</text> </paragraph> <paragraph num="(j)"> <text>If the subcontractor is authorized by the MCO to make referrals, a provision requiring the subcontractor to use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06;</text> </paragraph> <paragraph num="(k)"> <text>A provision to the effect that each provision of the subcontract that is required under this section supersede and be controlling over any conflicting terms that appear in the subcontract;</text> </paragraph> <paragraph num="(l)"> <text>A provision for revocation of the delegation of activities or obligations, or specifying other remedies in instances where the Department or the MCO determines that the subcontractor has not performed satisfactorily;</text> </paragraph> <paragraph num="(m)"> <text>A provision stating that the MCO has the right to audit the subcontractor pursuant to 42 CFR §438.230(c)(3)(i) for 10 years from the final date of the contract period or from the date of completion of any audit, whichever is later; and</text> </paragraph> <paragraph num="(n)"> <text>A provision to the effect that all providers and subcontractors are subject to a grievance and appeal system consistent with the requirements of COMAR 10.67.09.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An MCO may not subcontract for hospital services with a hospital or an entity related to a hospital unless that hospital is in compliance with COMAR 10.37.12 (fixed price contracting regulations).</text> </paragraph> <paragraph num="(5)"> <text>An MCO may not prohibit or otherwise restrict a health care professional, acting within the lawful scope of practice, from advising or advocating on behalf of an enrollee who is the provider's patient for:</text> <paragraph num="(a)"> <text>The enrollee's health status, medical care, or treatment options, including any alternative treatment that may be self-administered;</text> </paragraph> <paragraph num="(b)"> <text>Any information the enrollee needs in order to decide among all relevant treatment options;</text> </paragraph> <paragraph num="(c)"> <text>The risks, benefits, and consequences of treatment or nontreatment; or</text> </paragraph> <paragraph num="(d)"> <text>The enrollee's right to participate in decisions regarding the enrollee's own health care, including the right to refuse treatment, and to express preferences about future treatment decisions.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Subcontractual Relations Reporting Requirements.</text> <paragraph num="(1)"> <text>An MCO shall submit its standard subcontract to the Department for its approval at least 30 days in advance of the MCO entering into any subcontracts covered by this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall submit to the Department for its prior approval material modifications to, or deviations from, its approved standard subcontract.</text> </paragraph> <paragraph num="(3)"> <text>An MCO shall submit to the Department a specification of procedures to be followed when reallocating responsibility in the event of a change in obligations in its approved standard subcontract.</text> </paragraph> <paragraph num="(4)"> <text>Network Provider Termination.</text> <paragraph num="(a)"> <text>When an MCO and provider terminate their contract the MCO shall provide the Department with a written notice regarding the termination.</text> </paragraph> <paragraph num="(b)"> <text>If the MCO is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided at the later of:</text> <paragraph num="(i)"> <text>30 calendar days before the effective date of the termination; or</text> </paragraph> <paragraph num="(ii)"> <text>15 calendar days after receipt or issuance of the termination notice.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the provider is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided within 15 days after the MCO receives the notice from the terminating provider.</text> </paragraph> <paragraph num="(d)"> <text>If 50 to 99 enrollees are affected, the notice shall contain the:</text> <paragraph num="(i)"> <text>Date of termination;</text> </paragraph> <paragraph num="(ii)"> <text>Name or names of providers or subcontractors terminating;</text> </paragraph> <paragraph num="(iii)"> <text>Number of enrollees affected; and</text> </paragraph> <paragraph num="(iv)"> <text>MCO's plan for transitioning enrollees to other providers.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>If more than 99 enrollees are affected, the MCO shall provide the Department with a Department-approved termination survey.</text> </paragraph> <paragraph num="(f)"> <text>In determining the number of enrollees affected under §B(4)(d) and (e) of this regulation, the MCO shall consider:</text> <paragraph num="(i)"> <text>For PCPs, the number of enrollees assigned to the PCP; and</text> </paragraph> <paragraph num="(ii)"> <text>For all other providers, the number of enrollees who are in active treatment or who have had an encounter with the provider in the previous 12 months.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Subcontractor Termination.</text> <paragraph num="(a)"> <text>When an MCO terminates a subcontract impacting its operations, covered services, or enrollees, the MCO shall provide the Department with written notice regarding the termination that describes:</text> <paragraph num="(i)"> <text>The dollar amount of the subcontract;</text> </paragraph> <paragraph num="(ii)"> <text>The effect of the termination on MCO operations;</text> </paragraph> <paragraph num="(iii)"> <text>The effect of the termination on MCO covered services or enrollees; and</text> </paragraph> <paragraph num="(iv)"> <text>The MCO’s plan to replace the subcontractor, if applicable.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the termination of the subcontract impacts MCO operations, the notice required in §B(5)(a) of this regulation shall be provided at least 90 days before the effective date of the termination.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>By entering into a subcontract to provide health care services on behalf of an MCO, the subcontractor becomes subject to all the requirements concerning audits and inspections by the Department and other government agencies that are imposed upon the MCO by statute or regulation, or by its contract with the Department.</text> </paragraph> <paragraph num="D."> <text>An MCO shall monitor the performance of its subcontractors, including, but not limited to, the areas of enrollee and provider complaints, access issues, quality assurance activities, record keeping, and reporting requirements.</text> </paragraph> <paragraph num="E."> <text>An MCO shall report to the Department any material deviations from required procedures by its subcontractor which, in the MCO's judgment, can be expected to have a significant effect on quality of care, or on enrollees' ability to access care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Third-Party Liability."> <paragraph num="A."> <text>An MCO is responsible for the identification of, and collection of, moneys owing from responsible third parties liable for the cost of medical care furnished by the MCO to enrollees.</text> </paragraph> <paragraph num="B."> <text>Upon request from the Department or the U.S. Department of Health and Human Services, an MCO shall convey any information regarding third-party liability to the Department, to the U.S. Department of Health and Human Services, or to another MCO.</text> </paragraph> <paragraph num="C."> <text>The Department shall notify an MCO of any third-party liability identified during the course of eligibility determination.</text> </paragraph> <paragraph num="D."> <text>The MCO shall submit to the Department any new or changed third-party information in an automated format on a monthly basis.</text> </paragraph> <paragraph num="E."> <text>The Department shall provide the MCOs with any new or changed information on a monthly basis in an automated format.</text> </paragraph> <paragraph num="F."> <text>In order to facilitate the Department's and the U.S. Department of Health and Human Services' monitoring of its third-party liability collection activities, an MCO shall:</text> <paragraph num="(1)"> <text>Submit to the Department, on a monthly basis, reports on third-party collections and activities during the month, including but not limited to amounts the MCO has cost-avoided and recovered and current accounts receivable for all third-party liability cases;</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Department, on a quarterly basis and in a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter;</text> </paragraph> <paragraph num="(3)"> <text>Cooperate in site inspections by either the Department or the U.S. Department of Health and Human Services for monitoring purposes; and</text> </paragraph> <paragraph num="(4)"> <text>Submit a detailed report of third-party liability collection activities including, but not limited to, cost avoidance, recovered amounts, and current amounts receivable for cases selected by the Department.</text> </paragraph> </paragraph> <paragraph num="G."> <text>When both the Department and an MCO have a right of subrogation, they shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount.</text> </paragraph> <paragraph num="H."> <text>For insurance coverage identified by an MCO with a retroactive effective date, an MCO shall comply with Insurance Article, §15-1008, Annotated Code of Maryland.</text> </paragraph> <paragraph num="I."> <text>An MCO may not deny a provider’s request for a preauthorization solely because a recipient has, or is thought to have, third-party insurance.</text> </paragraph> <paragraph num="J."> <text>The requirement in §I of this regulation may not apply if an MCO has a process in place to ensure that a claim will not be denied for lack of preauthorization if the claim ultimately becomes the MCOs responsibility for one of the following reasons:</text> <paragraph num="(1)"> <text>The recipient does not have third-party insurance; or</text> </paragraph> <paragraph num="(2)"> <text>The service received is a noncovered service under the third-party insurance.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If an MCO identifies another party as being responsible for retroactive denial of reimbursement, the MCO shall:</text> <paragraph num="(1)"> <text>Obtain a written statement from the third-party that includes:</text> <paragraph num="(a)"> <text>The name and address of the third party; and</text> </paragraph> <paragraph num="(b)"> <text>Acknowledgment of responsibility for payment of the denied claim by the third party;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Send this written statement to the provider seeking reimbursement; and</text> </paragraph> <paragraph num="(3)"> <text>Provide this written statement or a summary report to the Department upon request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18-1" heading="MCO Reimbursement — GME Exclusion."> <paragraph num="A."> <text>Capitation Rate Setting Methodology — Extraction of Graduate Medical Education Costs.</text> <paragraph num="(1)"> <text>Percentage of Teaching Hospitals' Rates Representing GME Costs. The Department, in consultation with the HSCRC, shall:</text> <paragraph num="(a)"> <text>Determine the amount, expressed as a percentage, of payments by the Program that are attributable to GME, based on historic cost and discharge abstract data that:</text> <paragraph num="(i)"> <text>Are specific to each individual teaching hospital;</text> </paragraph> <paragraph num="(ii)"> <text>Are specific to Program recipients who would have been MCO-eligible if COMAR 10.67.01—.12 had been in effect at the time the activity reflected in the data occurred;</text> </paragraph> <paragraph num="(iii)"> <text>Reflect services that would be, if performed during the contract year to which calculations utilizing a teaching hospital's GME percentage amount relate, included in the mandatory MCO benefits package described in COMAR 10.67.06; and</text> </paragraph> <paragraph num="(iv)"> <text>Represent activity in FY 1995; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For any teaching hospital that is not in compliance with the primary care and innovation requirements of COMAR 10.10.67.11, reduce the Program's payments to the hospital deemed to be attributable to GME pursuant to §A(1)(a) of this regulation by the hospital's noncompliance penalty percentage derived in accordance with COMAR 10.67.11.03C.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>GME Percentage Start-Up Adjustment. To ameliorate the impact on MCOs that historically have experienced low utilization of teaching hospitals, the Department shall, during the first 3 years of separate GME funding, reduce the GME percentage determined in accordance with §A(1) of this regulation in the following amounts:</text> <paragraph num="(a)"> <text>FY 1999 ... 10 percent;</text> </paragraph> <paragraph num="(b)"> <text>FY 2000 ... 6.7 percent;</text> </paragraph> <paragraph num="(c)"> <text>FY 2001 ... 3.3 percent; and</text> </paragraph> <paragraph num="(d)"> <text>FY 2002 and thereafter ... 0 percent.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Modifying GME Percentage to Maintain Budget Neutrality.</text> <paragraph num="(a)"> <text>To maintain budget neutrality in the GME funding procedure established pursuant to this regulation and COMAR 10.67.11, the Department may modify the GME percentages established pursuant to §A(1) and (2) of this regulation.</text> </paragraph> <paragraph num="(b)"> <text>The Department may use the modified GME percentage authorized by §A(3)(a) of this regulation to calculate non-GME teaching hospital costs pursuant to §A(4) of this regulation, for the purpose of equalizing:</text> <paragraph num="(i)"> <text>The amount of GME costs to be excluded from capitation rates for the contract year pursuant to §A(4) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>The amount of GME allocation payments, determined pursuant to COMAR 10.67.11.03C.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Application of the GME percentage modification authorized in §A(3)(a) and (b) of this regulation does not affect the amount of the GME allocation payments made pursuant to COMAR 10.67.11.03C.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>GME Adjustment in Capitation Rate-Setting Methodology.</text> <paragraph num="(a)"> <text>Before determining the average historic costs assigned to the rate cells set forth in Regulation .19B of this chapter, the Department shall, consistent with §A(1)—(3) of this regulation, deduct, for each rate cell, the dollar amount allocatable to GME contained in the Department's base year payments to teaching hospitals.</text> </paragraph> <paragraph num="(b)"> <text>The deduction referenced in §A(4)(a) of this regulation is calculated as follows:</text> <paragraph num="(i)"> <text>For each payment included in the base year data made by the Program to a teaching hospital in the contract year, the amount of the payment is multiplied by the hospital-specific GME percentage, established pursuant to §A(1)—(3) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>The dollar amount attributable to GME that is included in the base year payments, as identified by the procedure described in §A(4)(b)(i) of this regulation, is subtracted from the total amount of the payment to yield the non-GME portion of the payment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Consistent with §A(4) of this regulation, the Department shall use the GME percentage rates calculated pursuant to §A(1)—(3) of this regulation for purposes of:</text> <paragraph num="(a)"> <text>Calculating each teaching hospital's GME allocation payment amounts pursuant to COMAR 10.67.11.03C;</text> </paragraph> <paragraph num="(b)"> <text>Determining the amount of each ACG's average non-GME historic costs for grouping ACGs to make risk adjustment category assignments of the ACGs pursuant to Regulation .19B of this chapter;</text> </paragraph> <paragraph num="(c)"> <text>Determining the amount of each demographic grouping's average non-GME historic costs; and</text> </paragraph> <paragraph num="(d)"> <text>Determining, for each risk adjustment category and demographic grouping, the capitation rates set forth in Regulation .19B of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall use, in calculating the capitation rates set forth in Regulation .19B of this chapter, a capitation rate-setting methodology that:</text> <paragraph num="(1)"> <text>Excludes the dollar amount allocatable to GME, consistent with the percentage of GME included in historic payments made by the Program to teaching hospitals that receive GME allocation payments in the contract year, based on calculations that:</text> <paragraph num="(a)"> <text>Are consistent with §A of this regulation;</text> </paragraph> <paragraph num="(b)"> <text>Reflect any modifications made pursuant to §A(2) and (3) of this regulation to the percentage of the Program's historic payments made to teaching hospitals allocable to GME; and</text> </paragraph> <paragraph num="(c)"> <text>Reflect the reduction of hospital-specific GME percentages, by operation of COMAR 10.67.11.03C and §A(1)(b) of this regulation, to decrease the amount of GME allocation payments made, pursuant to COMAR 10.67.11.03B, to teaching hospitals that are not in compliance with the primary care and innovation requirements of COMAR 10.67.11;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Reduces historic costs to reflect savings expected to result from a managed care delivery system;</text> </paragraph> <paragraph num="(3)"> <text>Includes a trend factor to account for cost differences between the base year and the contract year;</text> </paragraph> <paragraph num="(4)"> <text>Excludes the dollar amount of historic payments determined, based on an aggregation of individual inpatients' payment data for the base year, to be avoidable by an MCO pursuant to Regulation .22 of this chapter, had the services been furnished during the contract year; and</text> </paragraph> <paragraph num="(5)"> <text>Beginning in FY 2000, takes into account Maryland Medicaid Managed Care Program enrollment of the newly eligible population entering the Program pursuant to the Maryland Children's Health Program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="MCO Reimbursement."> <paragraph num="A."> <text>Generally.</text> <paragraph num="(1)"> <text>Payment to an MCO for each enrollee shall be at a fixed capitation rate, as specified in §B(4) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall be reimbursed at rates set forth in this regulation only for individuals enrolled under the Maryland Medicaid Managed Care Program.</text> </paragraph> <paragraph num="(3)"> <text>The capitation rate paid to an MCO by the Department shall be accepted as payment in full for all benefits provided by the MCO.</text> </paragraph> <paragraph num="(4)"> <text>An MCO shall conform to the Department's computer coding requirements.</text> </paragraph> <paragraph num="(5)"> <text>A capitation payment may not be made to an MCO on behalf of an enrollee for whom capitation payment for the same period has been made to any other MCO having an agreement with the Department.</text> </paragraph> <paragraph num="(6)"> <text>The Department may consider a retroactive capitation payment to an MCO, if the MCO notifies the Department within 9 months of the first missed capitation payment for an enrollee for whom the MCO has not received all appropriate capitation payments.</text> </paragraph> <paragraph num="(7)"> <text>Monies collected by an MCO for third party liability, as described in Regulation .18 of this chapter, are considered when calculating the capitation payments in §B(4) of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Capitation Rate-Setting Methodology.</text> <paragraph num="(1)"> <text>Families and Children. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through TCA or programs for medically needy families and children, including SOBRA children and Maryland Children's Health Program (MCHP), shall be established as follows:</text> <paragraph num="(a)"> <text>For enrollees eligible under COMAR 10.67.02.01A(1) or (3), and for children eligible under COMAR 10.67.02.01A(2) for whom the Department has sufficient clinical data, the Department shall:</text> <paragraph num="(i)"> <text>Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's past diagnostic record;</text> </paragraph> <paragraph num="(ii)"> <text>Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of relatively homogenous resource utilization by ACG assignment; and</text> </paragraph> <paragraph num="(iii)"> <text>Assign an enrollee to a risk adjustment category based upon the enrollee's ACG assignment;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Except as provided in §B(1)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's:</text> <paragraph num="(i)"> <text>Age, residence, and gender; and</text> </paragraph> <paragraph num="(ii)"> <text>Birth weight with respect to an enrollee born after December 31, 2004; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>On the basis of the enrollee's residence, the Department shall assign:</text> <paragraph num="(i)"> <text>All SOBRA mothers enrolled pursuant to COMAR 10.67.02.01A(2) to one of the two “SOBRA mother” payment categories set forth in §B(4)(a) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(a) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Disabled. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled shall be established as follows:</text> <paragraph num="(a)"> <text>Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has sufficient clinical data, the Department shall:</text> <paragraph num="(i)"> <text>Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's diagnostic record;</text> </paragraph> <paragraph num="(ii)"> <text>Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of nearly homogenous resource utilization by ACG assignment; and</text> </paragraph> <paragraph num="(iii)"> <text>Assign an enrollee to a risk adjustment category (RAC) based upon the enrollee's ACG assignment; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's age, residence, and gender; and</text> </paragraph> <paragraph num="(c)"> <text>On the basis of the enrollee's residence, the Department shall assign:</text> <paragraph num="(i)"> <text>Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(b) of this regulation; and</text> </paragraph> <paragraph num="(ii)"> <text>Enrollees with AIDS to one of the two AIDS payment categories set forth in §B(4)(b) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Supplemental Delivery/Newborn Payments.</text> <paragraph num="(a)"> <text>In addition to the monthly payment specified in §B(4)(a) or (b) of this regulation for an enrollee's payment category, the Department shall pay an MCO one supplemental payment per pregnancy in the amount specified in §B(4)(c) of this regulation, upon delivery of one or more infants without regard to method, timing, or place of delivery.</text> </paragraph> <paragraph num="(b)"> <text>An MCO shall have 12 months from the date of delivery to bill for the supplemental payment.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Except to the extent of adjustments required by §D of this regulation or by Regulations .19-1 through 19-3 of this chapter, the Department shall make payments monthly at the rates specified in the following tables:</text> <paragraph num="(a)"> <text>Rate Table for Families and Children Effective January 1, 2020—December 31, 2020.</text> </paragraph> <paragraph num="(b)"> <text>Rate Table for Disabled Individuals Effective January 1, 2020— December 31, 2020.</text> </paragraph> <paragraph num="(c)"> <text>Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2020 December 31, 2020.</text> </paragraph> <paragraph num="(d)"> <text>Rate Table for Childless Adult Population Effective January 1, 2020—December 31, 2020.</text> </paragraph> <paragraph num="(e)"> <text>Rate Table for Families and Children Effective January 1, 2021—December 31, 2021.</text> </paragraph> <paragraph num="(f)"> <text>Rate Table for Disabled Individuals Effective January 1, 2021—December 31, 2021.</text> </paragraph> <paragraph num="(g)"> <text>Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2021—December 31, 2021.</text> </paragraph> <paragraph num="(h)"> <text>Rate Table for Childless Adult Population Effective January 1, 2021—December 31, 2021.</text> </paragraph> <paragraph num="(i)"> <text>Interpretation of Rate Table for Families and Children. The table found at §B(4)(a) of this regulation shows capitation rates for individuals who are:</text> <paragraph num="(i)"> <text>Waiver eligible based on receipt of benefits through TCA or programs for medically needy families and children;</text> </paragraph> <paragraph num="(ii)"> <text>SOBRA children;</text> </paragraph> <paragraph num="(iii)"> <text>SOBRA mothers; and</text> </paragraph> <paragraph num="(iv)"> <text>The Maryland Children's Health Program.</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Interpretation of Rate Table for Disabled Individuals. The table found at §B(4)(b) of this regulation shows the capitation rates for individuals who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled.</text> </paragraph> <paragraph num="(k)"> <text>Interpretation of Rate Table for Supplemental Payment for Delivery/Newborn. The table found at §B(4)(c) of this regulation shows a supplemental payment made in connection with deliveries of MCO enrollees, regardless of the enrollee's payment category under COMAR 10.67.04.19B(4)(a) or (b).</text> </paragraph> <paragraph num="(l)"> <text>Interpretation of Rate Tables in §B(4) of this regulation. “PMPM” means the per member per month payment rate.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Consistent with the terms set forth in Regulation .19-4 of this chapter, the Department may, in consultation with the Commissioner, adjust the capitation payment of an MCO if it determines that the MCO's loss ratio, not including any rebate received by the MCO is less than 85 percent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall reimburse fee-for-service:</text> <paragraph num="(1)"> <text>The Departmental share for any enrollee participating in the Stop Loss Program pursuant to Regulation .22 of this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>The cost of those services specified in COMAR 10.09.69.06.13 provided to the participant that have been authorized by the participant's case manager in accordance with the participant's plan of care.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Interim Rates Adjustments.</text> <paragraph num="(1)"> <text>Under the circumstances described in §D(2) and (3) of this regulation, the Department shall adjust the capitation rates set forth in §B(4)(a), (b), (e), and (f) of this regulation to reflect changes in service costs during the contract year due to an occurrence listed in §D(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>The Department shall adjust the payment rates specified in §B(4)(a)(h) of this regulation to reflect service cost changes that qualify under §D(3) of this regulation and result from:</text> <paragraph num="(a)"> <text>An addition or deletion of services covered under the HealthChoice benefits package;</text> </paragraph> <paragraph num="(b)"> <text>An increase or decrease in Medicaid fee-for-service payment rates or copayments, if the MCOs are obligated to adjust their payment rates to providers as a result of those fee-for-service rate changes;</text> </paragraph> <paragraph num="(c)"> <text>An increase or decrease in the inpatient charge per case as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided; or</text> </paragraph> <paragraph num="(d)"> <text>An increase or decrease in the outpatient charge per visit as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department shall make an interim rates adjustment if the effect of an occurrence listed in §D(2) of this regulation is sufficient to result in program-wide overpayment or underpayment of at least 0.2 percent because of the difference between:</text> <paragraph num="(a)"> <text>Service cost projections used to develop the rates set forth in §B(4)(a), (b), (e), and (f) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Service costs for the same period, taking into account an occurrence that is listed in §D(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department shall make any interim rate adjustments required by this section in amounts that are proportionate to the overpayments or underpayments described in §D(3) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>Provider rate adjustments as specified in §D(2)(b) of this regulation may not require the MCOs to pay providers more than the Medicaid fee-for-service rate.</text> </paragraph> <paragraph num="(6)"> <text>The Department shall make supplemental payments to an MCO that reflect increases in MCO provider payments for trauma services described in COMAR 10.25.10.</text> </paragraph> <paragraph num="(7)"> <text>The Department shall make an interim rates adjustment in Calendar Years 2022, 2023, 2024, and 2025 to account for changes in acuity due to alterations in redetermination and enrollment processes related to COVID-19.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Interim Rate Adjustment for Calendar Year 2025.</text> <paragraph num="(1)"> <text>The Department shall re-open the capitation rates for interim rate adjustments in Calendar Year 2025 to revisit the following adjustments:</text> <paragraph num="(a)"> <text>Risk adjustment;</text> </paragraph> <paragraph num="(b)"> <text>Trend;</text> </paragraph> <paragraph num="(c)"> <text>Administration;</text> </paragraph> <paragraph num="(d)"> <text>Regional factors; and</text> </paragraph> <paragraph num="(e)"> <text>Relational modeling.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To assist with the assessment, MCOs shall provide additional information to the Department upon request, including detailed claims data as well as a year-to-date HealthChoice Financial Monitoring Report for the calendar year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19-1" heading="MCO-Specific Case Mix Adjustment for HIV and AIDS with Hepatitis C."> <paragraph num="A."> <text>To reflect the higher level of risk associated with providing covered health care services pursuant to COMAR 10.67.06 to HIV/AIDS enrollees who also have Hepatitis C, the Department shall, to the extent provided by this regulation, make MCO-specific adjustments to payments for enrollees in HIV and AIDS payment categories to reflect the proportion of an MCO's HIV/AIDS enrollees who also have Hepatitis C.</text> </paragraph> <paragraph num="B."> <text>Identification of HIV/AIDS Enrollees with Hepatitis C.</text> <paragraph num="(1)"> <text>For each MCO, the Department shall consider historical encounter and fee-for-service data for enrollees assigned to HIV and AIDS payment categories:</text> <paragraph num="(a)"> <text>For the initial assessment period, as of June of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(b)"> <text>For the mid-year assessment period, as of December of the calendar year before the rate year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For each MCO, the Department shall determine which of the HIV/AIDS enrollees meeting the criteria set forth in §B(1) of this regulation also have Hepatitis C.</text> </paragraph> <paragraph num="(3)"> <text>The Department shall use encounter and fee-for-service data documenting services provided to the HIV/AIDS enrollees identified in accordance with §B(1) of this regulation for the appropriate historical diagnostic period:</text> <paragraph num="(a)"> <text>For the initial assessment period, through June of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(b)"> <text>For the mid-year assessment period, through December of the calendar year before the rate year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Methodology for Determining MCO-specific HIV and AIDS Case Mix Measures. For each MCO, the Department shall:</text> <paragraph num="(1)"> <text>Based on encounter and fee-for-service data from the appropriate historical diagnostic period, classify the MCO's HIV/AIDS enrollees identified pursuant to §B of this regulation as either:</text> <paragraph num="(a)"> <text>Hepatitis C-infected; or</text> </paragraph> <paragraph num="(b)"> <text>Hepatitis C-uninfected.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Average relative value for HIV and AIDS payment categories are as follows:</text> <paragraph num="(a)"> <text>Apply weights reflecting costs associated with Hepatitis C-infected and Hepatitis C-uninfected enrollees in each HIV and AIDS payment category to the MCO-specific distribution of HIV/AIDS enrollees who are Hepatitis C-infected or Hepatitis C-uninfected, as determined pursuant to §C(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>For each MCO, use the results of the calculations specified in §C(2)(a) of this regulation to separately calculate an average relative value for each of the HIV and AIDS payment categories.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>To determine an MCO's relative case mix factors, each MCO's relative values determined pursuant to §C(2)(b) of this regulation are divided by the overall average relative value determined pursuant to §C(2)(a) of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Methodology for MCO-Specific Case Mix-Adjusted HIV and AIDS Rates. For each MCO, the Department shall:</text> <paragraph num="(1)"> <text>Calculate MCO-specific HIV and AIDS relative case mix factors for each HIV and AIDS payment group pursuant to §C(3) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Calculate MCO-specific HIV and AIDS rates for the rate adjustment period by multiplying the risk adjustment factor derived pursuant to §D(1) of this regulation by the value specified for each HIV and AIDS payment group for the rate year; and</text> </paragraph> <paragraph num="(3)"> <text>Apply a budget neutrality adjustment to the values derived pursuant to §D(2) of this regulation so that the aggregate of payments to all MCOs pursuant to this regulation are equivalent to the aggregate of all payments that would be due to all MCOs in the absence of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Case Mix Updates. The Department shall:</text> <paragraph num="(1)"> <text>Update current enrollees' region of residence and enrollment categories by repeating the calculations in §§B—D of this regulation every 6 months using residence and enrollment data as of the enrollment month specified below:</text> <paragraph num="(a)"> <text>For the initial assessment period of each rate year, June of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(b)"> <text>For the mid-year assessment period of each rate year, December of the calendar year before the rate year; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated Hepatitis C-infected and Hepatitis C-uninfected distribution to compute its risk adjusted HIV and AIDS payment rates for each rate adjustment period, as described in §D of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19-2" heading="MCO Supplemental Payment for Transitional Encounter Data Adjustment."> <paragraph num="A."> <text>The Department may grant an adjustment to those MCOs for whom the uniform encounter data adjustment results in completeness factors that are below the Statewide average.</text> </paragraph> <paragraph num="B."> <text>The encounter adjustment for each MCO shall be determined for the Family and Children RACs and for the Disabled RACs respectively.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19-3" heading="MCO-Specific Case Mix Adjustment."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this regulation, in addition to the definitions set forth in COMAR 10.67.01, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Demographic rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(b) and B(2)(b) of this chapter.</text> </paragraph> <paragraph num="(b)"> <text>“Initial rate adjustment period” means the 6-month period beginning January 1 of the rate year.</text> </paragraph> <paragraph num="(c)"> <text>“Mid-year rate adjustment period” means the 6-month period beginning July 1 of the rate year.</text> </paragraph> <paragraph num="(d)"> <text>“RAC rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(a) and (2)(a) of this chapter.</text> </paragraph> <paragraph num="(e)"> <text>“Rate adjustment period” means a 6-month period within the rate year that includes:</text> <paragraph num="(i)"> <text>The initial rate adjustment period beginning January 1 of the rate year; and</text> </paragraph> <paragraph num="(ii)"> <text>The mid-year rate adjustment period beginning July 1 of the rate year.</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>“Rate year” means the calendar year to which the rates calculated pursuant to this regulation apply.</text> </paragraph> <paragraph num="(g)"> <text>“Risk Adjustment Category (RAC)” means a grouping of adjusted clinical groups (ACGs), each of which is associated with a similar level of risk.</text> </paragraph> <paragraph num="(h)"> <text>“Risk assessment cohort” means each of the eight groupings of enrollees, assigned on the basis of their:</text> <paragraph num="(i)"> <text>Program eligibility category, either “families and children”, as specified in Regulation .19B(1) of this chapter, or “disabled”, as specified in Regulation .19B(2) of this chapter;</text> </paragraph> <paragraph num="(ii)"> <text>Region of residence category, either in “Baltimore City” or in the “rest of State”; and</text> </paragraph> <paragraph num="(iii)"> <text>Age category, either at least 1 year old but younger than 21 years old, or 21 years old or older.</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>“Risk assessment year” means the calendar year 2 years before the rate year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>For calculating an adjustment to MCO payment rates reflecting the relative level of risk of providing enrollees assigned to demographic rate cells covered health care services pursuant to COMAR 10.67.06, the Department shall, for each MCO, identify the enrollees to be considered as follows:</text> <paragraph num="(1)"> <text>For each rate adjustment period in the rate year, identify the current demographic enrollees for each MCO who:</text> <paragraph num="(a)"> <text>In the risk assessment year:</text> <paragraph num="(i)"> <text>Were certified eligible for the Program for at least 6 months;</text> </paragraph> <paragraph num="(ii)"> <text>Were assigned to a demographic rate cell; and</text> </paragraph> <paragraph num="(iii)"> <text>As of June 30, were 1 year old or older; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>In the calendar year before the rate year:</text> <paragraph num="(i)"> <text>For the initial rate adjustment period calculation for the rate year 2004, were enrolled in the MCO in March;</text> </paragraph> <paragraph num="(ii)"> <text>For the initial rate adjustment period calculation for rate years after 2004, were enrolled in the MCO in June; and</text> </paragraph> <paragraph num="(iii)"> <text>For the mid-year rate adjustment period calculation, were enrolled in the MCO in December;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assign each enrollee identified pursuant to §B(1) of this regulation into one of the eight risk assessment cohorts;</text> </paragraph> <paragraph num="(3)"> <text>Make the determinations necessary for the assignments required by §B(2) of this regulation consistent with the following time frames:</text> <paragraph num="(a)"> <text>For an initial rate adjustment period calculation for the rate year 2004:</text> <paragraph num="(i)"> <text>An enrollee's eligibility category and region of residence as of March of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(ii)"> <text>An enrollee's age category as of March 31 of the calendar year before the rate year;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For an initial rate adjustment period calculation for rate years after 2004:</text> <paragraph num="(i)"> <text>An enrollee's eligibility category and region of residence as of June of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(ii)"> <text>An enrollee's age category as of June 30 of the calendar year before the rate year; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For a mid-year rate adjustment period calculation:</text> <paragraph num="(i)"> <text>An enrollee's eligibility category and region of residence as of December of the calendar year before the rate year; and</text> </paragraph> <paragraph num="(ii)"> <text>An enrollee's age category as of December 31 of the calendar year before the rate year; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>For calculating an MCO's case mix adjustment pursuant to this regulation, disregard any risk assessment cohorts to which fewer than 50 of an MCO's enrollees are assigned pursuant to §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Methodology for Determining MCO-specific RAC Case Mix Measures. For each MCO, the Department shall:</text> <paragraph num="(1)"> <text>Based on encounter and fee-for-service data documenting services delivered during the risk assessment year, determine the diagnoses attributable to an MCO's enrollees identified pursuant to §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Based on diagnoses in the risk assessment year, assign each enrollee identified pursuant to §B of this regulation to the appropriate risk adjustment category (RAC), consistent with the protocol set forth in Regulation .19B(1)(a) and (2)(a) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Apply the RAC rates for the appropriate rate adjustment period to the RAC distribution determined pursuant to §C(2) of this regulation;</text> </paragraph> <paragraph num="(4)"> <text>Using the results of the calculations specified in §C(3) of this regulation, calculate an MCO's average RAC rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and</text> </paragraph> <paragraph num="(5)"> <text>To determine an MCO's relative RAC case mix factors, divide each of the MCO's average RAC rates determined in accordance with §C(4) of this regulation by each overall average RAC rate for all MCOs for the same risk assessment cohort.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Methodology for Determining MCO-specific Demographic Case Mix Measures. For each MCO, the Department shall:</text> <paragraph num="(1)"> <text>Determine the demographic distribution of its current enrollees as specified in §B of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Apply the appropriate demographic rates for the rate adjustment period to the demographic distribution as determined pursuant to §D(1) of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Using the results of the calculations specified in §D(2) of this regulation, calculate the MCO's average demographic rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and</text> </paragraph> <paragraph num="(4)"> <text>To determine an MCO's relative demographic case mix factors, divide each of the MCO's average demographic rates determined pursuant to §D(3) of this regulation by each of the overall average of demographic rates for all MCOs for the same risk assessment cohort.</text> </paragraph> </paragraph> <paragraph num="E."> <text>MCO-Specific Case Mix Adjusted Demographic Rates. The Department shall, for each MCO:</text> <paragraph num="(1)"> <text>Calculate MCO-specific risk adjustment factors by dividing, for each risk assessment cohort, the relative RAC case mix factor determined pursuant to §C of this regulation, by the relative demographic case mix factor determined pursuant to §D of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Modify the MCO-specific risk adjustment factor derived for each risk assessment cohort pursuant to §E(1) of this regulation as follows:</text> <paragraph num="(a)"> <text>Reduce each risk adjustment factor that is higher than 1.1 to 1.1; and</text> </paragraph> <paragraph num="(b)"> <text>Increase each risk adjustment factor that is lower than 0.9 to 0.9;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Subject to §E(4) of this regulation, calculate the MCO-specific demographic rates for the rate adjustment period by multiplying the risk adjustment factor for each risk assessment cohort, derived pursuant to §E(1) of this regulation, by the value specified in each demographic rate cell for the rate year; and</text> </paragraph> <paragraph num="(4)"> <text>Apply a budget neutrality adjustment to the values derived in §E(3) of this regulation so that aggregate payments to all MCOs pursuant to this regulation are equivalent to the aggregate payments that would be due to all MCOs in the absence of this regulation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Case Mix Updates. The Department shall:</text> <paragraph num="(1)"> <text>Repeat the calculations described in §§C—E of this regulation every 6 months to update current MCO enrollees' region of residence, age, and enrollment categories as of the calendar year before the rate year, as provided in §B(3) of this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>For the rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated RAC case mix measures and updated demographic case mix measures to compute its demographic rates for the rate adjustment period, as described in §E of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19-4" heading="MCO Medical Loss Ratio."> <paragraph num="A."> <text>By September 1 of the second calendar year following the MLR reporting year, each MCO shall provide to the Department a completed MLR Reporting Template, including the MCO attestation and any additional documentation supporting the MLR reporting template.</text> </paragraph> <paragraph num="B."> <text>The MLR experienced for each MCO in an MLR reporting year is the ratio of the numerator, as defined in §D of this regulation, to the denominator, as defined in §E of this regulation.</text> </paragraph> <paragraph num="C."> <text>An MLR may be increased by a credibility adjustment, in accordance with §G of this regulation.</text> </paragraph> <paragraph num="D."> <text>Components of MLR — Numerator.</text> <paragraph num="(1)"> <text>The numerator of an MCO's MLR for an MLR reporting year is the sum of the MCO's incurred claims, the MCO's expenditures for activities that improve health care quality, and fraud prevention activities.</text> </paragraph> <paragraph num="(2)"> <text>Incurred Claims. Incurred claims include the following:</text> <paragraph num="(a)"> <text>Direct claims that the MCO paid to providers, including under capitated contracts with network providers, for services or supplies covered under the contract and services meeting the requirements of 42 CFR §438.3(e) provided to enrollees;</text> </paragraph> <paragraph num="(b)"> <text>Unpaid claims liabilities for the MLR reporting year, including claims reported that are in the process of being adjusted or claims incurred but not reported;</text> </paragraph> <paragraph num="(c)"> <text>Withholds from payments made to network providers;</text> </paragraph> <paragraph num="(d)"> <text>Claims that are recoverable for anticipated coordination of benefits;</text> </paragraph> <paragraph num="(e)"> <text>Claims payments recoveries received because of subrogation;</text> </paragraph> <paragraph num="(f)"> <text>Incurred but not reported claims based on past experience, and modified to reflect current conditions, such as changes in exposure or claim frequency or severity;</text> </paragraph> <paragraph num="(g)"> <text>Changes in other claims-related reserves; and</text> </paragraph> <paragraph num="(h)"> <text>Reserves for contingent benefits and the medical claim portion of lawsuits.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An MCO shall deduct the following amounts from incurred claims:</text> <paragraph num="(a)"> <text>Overpayment recoveries received from network providers; and</text> </paragraph> <paragraph num="(b)"> <text>Prescription drug rebates received and accrued.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An MCO shall include the following expenditures in incurred claims:</text> <paragraph num="(a)"> <text>The amount of incentive and bonus payments made, or expected to be made, to network providers; and</text> </paragraph> <paragraph num="(b)"> <text>The amount of claims payments recovered through fraud reduction efforts, not to exceed the amount of fraud reduction expenses, and excluding activities specified in §D(3) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>An MCO may include or deduct the following amounts from incurred claims:</text> <paragraph num="(a)"> <text>Net payments; or</text> </paragraph> <paragraph num="(b)"> <text>Receipts related to State-mandated solvency funds;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>An MCO shall exclude the following amounts from incurred claims:</text> <paragraph num="(a)"> <text>Non-claims costs;</text> </paragraph> <paragraph num="(b)"> <text>Amounts paid to the State as remittance under §I of this regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Amounts paid to network providers under to 42 CFR §438.6(d).</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Non-claims costs as described in §D(6)(a) of this regulation include the following:</text> <paragraph num="(a)"> <text>Amounts paid to third-party vendors for secondary network savings;</text> </paragraph> <paragraph num="(b)"> <text>Amounts paid to third-party vendors for network development, administrative fees, claims processing, and utilization management;</text> </paragraph> <paragraph num="(c)"> <text>Amounts paid, including amounts paid to a provider, for professional or administrative services that do not represent compensation or reimbursement for State plan services or services meeting the definition in 42 CFR §438.3(e) and provided to an enrollee; and</text> </paragraph> <paragraph num="(d)"> <text>Fines and penalties assessed by regulatory authorities.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Incurred claims paid by one MCO that are later assumed by another MCO shall be reported by the assuming MCO for the entire MLR reporting year, and no incurred claims for that MLR reporting year may be reported by the ceding MCO.</text> </paragraph> <paragraph num="(9)"> <text>An MCO shall include activities that improve health care quality in one of the following categories:</text> <paragraph num="(a)"> <text>An MCO activity that meets the requirements of 45 CFR §158.150(b) and is not excluded under 45 CFR §158.150(c);</text> </paragraph> <paragraph num="(b)"> <text>An MCO activity related to any EQR-related activity as described in 42 CFR §438.358(b) and (c); and</text> </paragraph> <paragraph num="(c)"> <text>Any MCO expenditure that is related to Health Information Technology and meaningful use, meets the requirements placed on issuers found in 45 CFR §158.151, and is not considered incurred claims.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Excluding expenses for fraud reduction efforts in §D(4)(b) of this regulation, an MCO shall include expenditures on activities related to fraud prevention as adopted for the private market at 45 CFR part 158.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Components of MLR Denominator.</text> <paragraph num="(1)"> <text>The denominator of an MCO's MLR for an MLR reporting year shall equal the adjusted premium revenue. The adjusted premium revenue is the MCO's premium revenue minus the MCO's federal, State, and local taxes and licensing and regulatory fees and is aggregated in accordance with §F of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Premium revenue includes the following for the MLR reporting year:</text> <paragraph num="(a)"> <text>State capitation payments, developed in accordance with 42 CFR §438.4, to the MCO for all enrollees under a risk contract approved under 42 CFR §438.3(a), excluding payments made under 42 CFR §438.6(d);</text> </paragraph> <paragraph num="(b)"> <text>State-developed, one-time payments, for specific life events of enrollees;</text> </paragraph> <paragraph num="(c)"> <text>Other payments to the MCO approved under 42 CFR §438.6(b)(3);</text> </paragraph> <paragraph num="(d)"> <text>Unpaid cost-sharing amounts that the MCO could have collected from enrollees under the contract, except those amounts the MCO can show it made a reasonable, but unsuccessful, effort to collect;</text> </paragraph> <paragraph num="(e)"> <text>All changes to unearned premium reserves; and</text> </paragraph> <paragraph num="(f)"> <text>Net payments or receipts related to risk sharing mechanisms developed in accordance with 42 CFR §438.5 or 42 CFR §438.6.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Federal, State, and Local Taxes and Licensing and Regulatory Fees. Taxes and licensing and regulatory fees for the MLR reporting year include:</text> <paragraph num="(a)"> <text>Statutory assessments to defray the operating expenses of any State or federal department;</text> </paragraph> <paragraph num="(b)"> <text>Examination fees in lieu of premium taxes as specified by State law;</text> </paragraph> <paragraph num="(c)"> <text>Federal taxes and assessments allocated to MCOs excluding federal income taxes on investment income and capital gains and federal employment taxes;</text> </paragraph> <paragraph num="(d)"> <text>State and local taxes and assessments including:</text> <paragraph num="(i)"> <text>Any industrywide (or subset) assessments, other than surcharges on specific claims, paid to the State or locality directly;</text> </paragraph> <paragraph num="(ii)"> <text>Guaranty fund assessments;</text> </paragraph> <paragraph num="(iii)"> <text>Assessments of State or locality industrial boards or other boards for operating expenses or for benefits to sick employed persons in connection with disability benefit laws or similar taxes levied by states;</text> </paragraph> <paragraph num="(iv)"> <text>State or locality income, excise, and business taxes other than premium taxes and State employment and similar taxes and assessments; and</text> </paragraph> <paragraph num="(v)"> <text>State or locality premium taxes plus State or locality taxes based on reserves, if in lieu of premium taxes; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Payments made by an MCO that are otherwise exempt from federal income taxes, for community benefit expenditures as defined in 45 CFR §158.162(c), limited to the highest of either:</text> <paragraph num="(i)"> <text>3 percent of earned premium; or</text> </paragraph> <paragraph num="(ii)"> <text>The highest premium tax rate in the State for which the report is being submitted, multiplied by an MCO's earned premium in the State.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>The total amount of the denominator for an MCO, which is later assumed by another MCO, shall be reported by the assuming MCO for the entire MLR reporting year and no amount under this section for that year may be reported by the ceding MCO.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Allocation of Expense.</text> <paragraph num="(1)"> <text>Each expense shall be included under only one type of expense, unless a portion of the expense fits under the definition of, or criteria for, one type of expense and the remainder fits into a different type of expense, in which case the MCO shall prorate the expense between types of expenses.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall report on a pro-rata basis any expenditures that benefit multiple contracts or populations, or contracts other than those being reported.</text> </paragraph> <paragraph num="(3)"> <text>Methods Used to Allocate Expenses.</text> <paragraph num="(a)"> <text>An MCO shall base allocation to each category on a generally accepted accounting method that is expected to yield the most accurate results.</text> </paragraph> <paragraph num="(b)"> <text>An MCO shall apportion shared expenses, including expenses under the terms of a management contract, pro rata to the contract incurring the expense.</text> </paragraph> <paragraph num="(c)"> <text>The reporting entity shall bear any expenses that relate solely to its operation and may not apportion its operating expenses to other entities.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>Credibility Adjustment.</text> <paragraph num="(1)"> <text>An MCO may add a credibility adjustment to a calculated MLR if the MLR reporting year experience has partial credibility.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall add the credibility adjustment to the reported MLR calculation before calculating any remittances if required by the State as described in §I of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>An MCO may not add a credibility adjustment to a calculated MLR if the MLR reporting year experience has full credibility.</text> </paragraph> <paragraph num="(4)"> <text>If an MCO's experience has no credibility, it is presumed to meet or exceed the MLR calculation standards in this regulation.</text> </paragraph> <paragraph num="(5)"> <text>MCOs shall use the base credibility factors CMS publishes on an annual basis that are developed according to the methodology in 42 CFR §438.8(h)(4).</text> </paragraph> </paragraph> <paragraph num="H."> <text>Eligibility Groups.</text> <paragraph num="(1)"> <text>MCOs shall aggregate data for all Medicaid eligibility groups covered under the contract with the Department.</text> </paragraph> <paragraph num="(2)"> <text>MCOs shall report, and the Department shall calculate, an annual MLR as described in this regulation separately for the childless adult population.</text> </paragraph> <paragraph num="(3)"> <text>The Department may require separate reporting and a separate MLR calculation for additional populations.</text> </paragraph> </paragraph> <paragraph num="I."> <text>An MCO shall provide a remittance for an MLR reporting year if the MLR for that MLR reporting year does not meet the minimum MLR standard of 85 percent.</text> </paragraph> <paragraph num="J."> <text>Newly Contracted MCOs.</text> <paragraph num="(1)"> <text>The Department may exclude an MCO that is newly contracted with the State from the requirements in this section for the first year of the MCO's operation.</text> </paragraph> <paragraph num="(2)"> <text>Newly contracted MCOs shall comply with the requirements in this section during the next MLR reporting year in which the MCO is in business with the State, even if the first year was not a full 12 months.</text> </paragraph> </paragraph> <paragraph num="K."> <text>If the Department makes a retroactive change to the capitation payments for an MLR reporting year where the report has already been submitted to the Department, the MCO shall recalculate the MLR for all MLR reporting years affected by the change and submit a new report.</text> </paragraph> <paragraph num="L."> <text>MCOs shall attest to the accuracy of the calculation of the MLR in accordance with requirements of this section when submitting its report to the Department.</text> </paragraph> <paragraph num="M."> <text>MCOs shall report fraud prevention activities as required by 42 CFR §438.8.</text> </paragraph> <paragraph num="N."> <text>Notice and Appeal.</text> <paragraph num="(1)"> <text>Within 30 days of its receipt of the notice of a remittance being due to the Department, an MCO may appeal the remittance as a sanction pursuant to COMAR 10.67.10.02.</text> </paragraph> <paragraph num="(2)"> <text>An MCO's appeal does not stay the obligation of the MCO to remit the amount owed to the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="MCO Payment for Self-Referred, Emergency, Physician, and Hospital Services."> <paragraph num="A."> <text>MCO Payment for Self-Referred Services.</text> <paragraph num="(1)"> <text>For undisputed claims that are submitted to the MCO within 6 months of the date of service, an MCO shall reimburse out-of-plan providers within 30 days for eligible services performed upon an enrollee who has self-referred:</text> <paragraph num="(a)"> <text>To a school-based health clinic pursuant to COMAR 10.67.06.28B, for services described in COMAR 10.67.07;</text> </paragraph> <paragraph num="(b)"> <text>For family planning services, pursuant to COMAR 10.67.06.28A;</text> </paragraph> <paragraph num="(c)"> <text>For an initial medical examination for an enrollee who is a child in State-supervised care, pursuant to Regulation .13F of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>For one annual diagnostic and evaluation service visit for an enrollee diagnosed with human immunodeficiency virus or acquired immune deficiency syndrome (HIV/AIDS) pursuant to COMAR 10.67.06.28E;</text> </paragraph> <paragraph num="(e)"> <text>For obstetric and gynecologic care provided to a pregnant woman, under the circumstances described in COMAR 10.67.06.28C; and</text> </paragraph> <paragraph num="(f)"> <text>For an initial medical examination of a newborn when the:</text> <paragraph num="(i)"> <text>Examination is performed in a hospital by an on-call physician; and</text> </paragraph> <paragraph num="(ii)"> <text>MCO failed to provide for the service before the newborn's discharge from the hospital.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for school-based services as described in COMAR 10.67.07.03 and family planning services including office visits (CPT codes 9920199205 and 9921199215), preventive medicine office visits (CPT codes 9938399386 and 9939399396), and all FDA-approved contraceptive devices, methods and supplies, at the established Medicaid rates.</text> </paragraph> <paragraph num="(3)"> <text>An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for an initial examination for a child in State-supervised care utilizing the Medicaid payment schedule for the following procedure codes:</text> </paragraph> <paragraph num="(4)"> <text>An MCO shall reimburse out-of-plan providers rendering pregnancy-related services, as described in COMAR 10.67.06.28, at the Medicaid rate.</text> </paragraph> <paragraph num="(5)"> <text>An MCO shall reimburse out-of-plan providers performing the DES for HIV/AIDS at the Medicaid rate.</text> </paragraph> <paragraph num="(6)"> <text>An MCO may require enrollees to utilize in-plan providers for pharmacy and laboratory services ordered by out-of-plan providers of self-referral services, except as provided in §A(7) of this regulation.</text> </paragraph> <paragraph num="(7)"> <text>An MCO shall reimburse out-of-plan providers at the Medicaid rate for medically necessary pharmacy and laboratory services when the pharmacy or laboratory service is provided:</text> <paragraph num="(a)"> <text>In connection with a self-referred service specified in §A(1) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>On-site by the out-of-plan provider at the same location that the self-referred service specified in §A(1) of this regulation was delivered to the MCO's enrollee.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>An MCO shall reimburse out-of-plan providers for renal dialysis services in a Medicare-certified facility, at least the Medicaid rate, regardless of whether or not the MCO's preauthorization was secured.</text> </paragraph> <paragraph num="(9)"> <text>An MCO shall reimburse out-of-plan providers under the circumstances described in COMAR 10.67.06.28G at a rate not less than the fee-for-service Medicaid rate for an initial medical examination of a newborn when the mother's MCO fails to provide for the service before the newborn is discharged from the hospital.</text> </paragraph> <paragraph num="(10)"> <text>An MCO shall reimburse out-of-plan providers at the Medicaid fee-for-service rate for services performed in a free-standing birth center as described in COMAR 10.67.06.28.</text> </paragraph> <paragraph num="(11)"> <text>An MCO shall reimburse out-of-plan doulas at the Medicaid fee-for-service rate for services performed during the prenatal, labor and delivery, and postpartum periods of pregnancy as described in COMAR 10.67.06.28 through December 31, 2025.</text> </paragraph> </paragraph> <paragraph num="B."> <text>MCO Payment for Emergency Services Provided at a Hospital. An MCO shall reimburse a hospital emergency facility and provider, which is not required to obtain prior authorization or approval for payment from an MCO in order to obtain reimbursement under this regulation, for:</text> <paragraph num="(1)"> <text>Health care services that meet the definition of emergency services in Health-General Article, §19-701, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Medical screening services rendered to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act;</text> </paragraph> <paragraph num="(3)"> <text>Medically necessary services if the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility and the medically necessary services are related to the emergency condition; and</text> </paragraph> <paragraph num="(4)"> <text>Medically necessary services that relate to the condition presented and that are provided by the provider in the emergency facility to the enrollee if the MCO fails to provide 24-hour access to a physician.</text> </paragraph> </paragraph> <paragraph num="C."> <text>MCO Payment to an Out-of-Network Federally Qualified Health Center for Services Immediately Required Due to an Unforeseen Illness, Injury, or Condition.</text> <paragraph num="(1)"> <text>Effective October 1, 2010, an MCO shall reimburse an out-of-network federally qualified health center (FQHC) for services provided to an enrollee that are immediately required due to an unforeseen illness, injury, or condition if:</text> <paragraph num="(a)"> <text>The FQHC participates in the Medical Assistance Program;</text> </paragraph> <paragraph num="(b)"> <text>The FQHC does not have a contract with the MCO;</text> </paragraph> <paragraph num="(c)"> <text>The services are immediately required due to the enrollee's unforeseen illness, injury, or condition;</text> </paragraph> <paragraph num="(d)"> <text>The emergent services are provided on site at the FQHC; and</text> </paragraph> <paragraph num="(e)"> <text>The FQHC has, before rendering services, verified with the enrollee's primary care provider that the enrollee cannot be seen within a reasonable amount of time based on the severity of the enrollee's condition.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO may require that the FQHC provide documentation that the FQHC has obtained the verification required under §C(1)(e) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation.</text> </paragraph> <paragraph num="(3)"> <text>An MCO may require that the FQHC provide documentation that services were required for the reasons identified under §C(1)(c) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation.</text> </paragraph> <paragraph num="(4)"> <text>The rate at which the MCO shall reimburse an out-of-network FQHC for services provided under §C(1) of this regulation shall be the rate identified in COMAR 10.67.04.21.</text> </paragraph> <paragraph num="(5)"> <text>For any reimbursement paid by an MCO under §C of this regulation, the Program shall pay the MCO the difference between the rates identified in COMAR 10.67.04.21 and COMAR 10.09.08.05-1.</text> </paragraph> </paragraph> <paragraph num="D."> <text>MCO Payment for Provider Services.</text> <paragraph num="(1)"> <text>An MCO shall pass on to providers any MCO rate adjustment that is specified by the Department for a fee increase.</text> </paragraph> <paragraph num="(2)"> <text>For inpatient services performed in hospitals, an MCO shall pay all providers, regardless of the provider's contracting status, at least the Medicaid fee-for-service rate.</text> </paragraph> <paragraph num="(3)"> <text>The MCO may not be required to pay providers more than the Medicaid fee-for-service rate.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Payment for Hospital Services.</text> <paragraph num="(1)"> <text>An MCO shall reimburse Maryland hospital providers on the basis of rates approved by the Maryland Health Services Cost Review Commission (HSCRC).</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall reimburse hospital administrative days at the Medicaid fee-for-service rate.</text> </paragraph> <paragraph num="(3)"> <text>Upon the direction of the Department, an MCO shall reduce payments by 20 percent to a hospital located in a contiguous state or in the District of Columbia for services rendered to its enrollees, if the hospital has failed to supply appropriate discharge data to the Health Services Cost Review Commission.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Payments to Federally Qualified Health Centers (FQHC)."> <paragraph num="A."> <text>FQHC’s shall be reimbursed under the Alternative Payment System (APS).</text> <paragraph num="(1)"> <text>The Department shall:</text> <paragraph num="(a)"> <text>Pay the MCO a prospective payment based on encounter data; and</text> </paragraph> <paragraph num="(b)"> <text>Reconcile the prospective amount paid to the MCO with the MCO's actual expenditure amount, after receipt of MCO encounter data; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>MCOs shall reimburse any contracted FQHC, the FQHC’s rate established in accordance with COMAR 10.09.08.05-1A.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For self-referred services described in Regulation .20 of this chapter, the MCO shall pay the FQHC’s usual rate in accordance with §A of this regulation, regardless of the FQHC’s contracted status with the MCO.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Stop Loss Program."> <paragraph num="A."> <text>An MCO shall qualify for protection under the Stop Loss Program if:</text> <paragraph num="(1)"> <text>It was participating in HealthChoice as of April 1, 1999;</text> </paragraph> <paragraph num="(2)"> <text>It was unable to self-insure or obtain a contract with another entity for Stop Loss reinsurance after July 1, 1999; and</text> </paragraph> <paragraph num="(3)"> <text>By July 1, 1999, the MCO requested the Department to continue to provide Stop Loss Protection at a rate determined by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall notify the Department that the acute inpatient hospital costs of an enrollee are expected to exceed the Stop Loss limit as soon as it knows that this is likely to occur.</text> </paragraph> <paragraph num="C."> <text>Upon confirming eligibility for stop loss protection, the Department shall assume liability for reimbursement of 90 percent of accrued acute inpatient hospital charges according to established Medicaid fee-for-service rates for medically necessary acute inpatient treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year.</text> </paragraph> <paragraph num="D."> <text>An MCO shall remain financially liable for reimbursing 10 percent of accrued acute inpatient hospital charges for medically necessary treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year, and shall maintain full responsibility for the provision of health care services to the enrollee.</text> </paragraph> <paragraph num="E."> <text>At the beginning of the next calendar year, an MCO shall reassume full financial responsibility and full discretion for developing medical treatment plans for any enrollee who qualified for the Stop Loss Program.</text> </paragraph> <paragraph num="F."> <text>The Department's Extended Stop Loss Period.</text> <paragraph num="(1)"> <text>If an inpatient enrollee remains hospitalized at the end of a calendar year and incurs acute hospital costs that exceed the Stop Loss limit into the following calendar year without interruption, the Department's stop loss period shall be extended until the end of that hospitalization.</text> </paragraph> <paragraph num="(2)"> <text>The MCO shall remain financially liable for costs up to the Stop Loss limit for enrollees who remain hospitalized in an acute setting at the end of the calendar year as specified in §§A and D of this regulation until the enrollee is discharged.</text> </paragraph> </paragraph> <paragraph num="G."> <text>For calendar year 2001 and beyond, the MCO shall submit the MCO's Stop Loss Reinsurance Plan or Self-Insurance Plan to the Maryland Insurance Administration.</text> </paragraph> <paragraph num="H."> <text>If an MCO chooses to have the Department provide its Stop Loss coverage, an adjustment will be made to the capitation amount the MCO is paid.</text> </paragraph> <paragraph num="I."> <text>Upon the termination of the provider agreement between the enrollee's MCO and the Department, if an MCO has failed to fulfill its financial liability under this regulation, the Department shall assume responsibility only for costs that exceed the Stop Loss limit as specified in §C of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Marketing."> <paragraph num="A."> <text>An MCO may not have face-to-face or telephone contact with a recipient, or otherwise solicit a recipient who is not an enrollee of the MCO, unless authorized by the Department or the recipient initiates the contact.</text> </paragraph> <paragraph num="B."> <text>Subject to prior approval by the Department, an MCO may engage in marketing activities designed to make recipients aware of their availability, as well as any special services they offer. Unless they involve face-to-face solicitation, these marketing activities may involve campaigns using but not limited to:</text> <paragraph num="(1)"> <text>Television;</text> </paragraph> <paragraph num="(2)"> <text>Radio;</text> </paragraph> <paragraph num="(3)"> <text>Newspaper;</text> </paragraph> <paragraph num="(4)"> <text>Informational booths at public events;</text> </paragraph> <paragraph num="(5)"> <text>Billboards and other public displays;</text> </paragraph> <paragraph num="(6)"> <text>Addressee-blind informational mailings, but only when mailed to the MCO's entire service area;</text> </paragraph> <paragraph num="(7)"> <text>Magazines;</text> </paragraph> <paragraph num="(8)"> <text>Airborne marketing displays; or</text> </paragraph> <paragraph num="(9)"> <text>Public conveyances.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO may not engage in any cold call marketing, including activities using or involving any of the following mechanisms:</text> <paragraph num="(1)"> <text>Direct marketing;</text> </paragraph> <paragraph num="(2)"> <text>Telephone solicitation;</text> </paragraph> <paragraph num="(3)"> <text>Door to door flyers;</text> </paragraph> <paragraph num="(4)"> <text>Email;</text> </paragraph> <paragraph num="(5)"> <text>Texting;</text> </paragraph> <paragraph num="(6)"> <text>Material or financial incentives of any kind, with the exception of advertising trinkets such as balloons or pens that have an acquisition cost of $5 or less; or</text> </paragraph> <paragraph num="(7)"> <text>Influencing enrollment in conjunction with the sale or offer of private insurance.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Standards for Departmental Approval of MCO Advertising.</text> <paragraph num="(1)"> <text>MCO advertising shall:</text> <paragraph num="(a)"> <text>Be based on documented fact;</text> </paragraph> <paragraph num="(b)"> <text>Identify all telephone numbers used that do not belong to the MCOs;</text> </paragraph> <paragraph num="(c)"> <text>Include the statement, “'HealthChoice' is a program of the Maryland Department of Health”; and</text> </paragraph> <paragraph num="(d)"> <text>Be at a fifth grade reading level.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>MCO advertising may not:</text> <paragraph num="(a)"> <text>Be false or misleading;</text> </paragraph> <paragraph num="(b)"> <text>Ascribe to the MCO unique coverage or services that are otherwise required by State or federal law or regulation;</text> </paragraph> <paragraph num="(c)"> <text>Assert that a recipient shall enroll in the MCO in order to obtain benefits or in order not to lose benefits; or</text> </paragraph> <paragraph num="(d)"> <text>Assert that the MCO is endorsed by CMS, the federal or State government or similar entity.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Repealed." /> <regulation prefix="Regulation" num=".25" heading="Enrollee Outreach Plan."> <paragraph num="A."> <text>An MCO shall submit to the Department, on an annual basis, a written enrollee outreach plan that:</text> <paragraph num="(1)"> <text>Describes how the MCO intends to comply, in the upcoming year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Provides evidence of the MCO's compliance during the previous year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Submission Date.</text> <paragraph num="(1)"> <text>An MCO applicant shall submit its initial enrollee outreach plan, as part of its MCO application, as required by COMAR 10.09.64.06O.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall submit by December 1 an enrollee outreach plan, including the information specified in §A of this regulation, to be reviewed as part of the triennial audit performed by an external quality review organization (EQRO).</text> </paragraph> <paragraph num="(3)"> <text>For years in which the triennial EQRO audit is not performed, an MCO shall submit by April 30 any changes to the enrollee outreach plan, including the information specified in §A of this regulation.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".26" heading="Time Period for Termination of Provider Agreement."> <paragraph num="A."> <text>An MCO may terminate its provider agreement with the State as provided in §§B—D of this regulation.</text> </paragraph> <paragraph num="B."> <text>The MCO shall provide written notification to the Department of the MCO's intent to terminate the MCO's provider agreement with the State for any given calendar year by the previous October 1.</text> </paragraph> <paragraph num="C."> <text>An MCO that has previously terminated the provider agreement with the State and would like to sign a new agreement with the State, shall follow the application process as specified under COMAR 10.67.03.</text> </paragraph> <paragraph num="D."> <text>The Department may waive the requirement under §B of this regulation if the Department determines that the circumstances warrant, including but not limited to a reduction in rates outside the normal rate setting process or an MCO exit from the program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".27" heading="Newborn Coordinator."> <paragraph num="A."> <text>An MCO shall identify a newborn coordinator who shall be available to providers during the MCO's business hours as a contact for concerns related to eligibility and provision of services to newborns.</text> </paragraph> <paragraph num="B."> <text>The newborn coordinator shall provide services for a newborn:</text> <paragraph num="(1)"> <text>Whose mother is enrolled in the MCO on the date of the newborn's birth; and</text> </paragraph> <paragraph num="(2)"> <text>Who is enrolled or who is autoassigned to the MCO after birth.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The newborn coordinator shall:</text> <paragraph num="(1)"> <text>Research and confirm the assignment of an eligible newborn to a managed care organization;</text> </paragraph> <paragraph num="(2)"> <text>Interface with the enrollment agent, the Department, the newborn coordinators of other MCOs, and the provider to resolve any eligibility issues involving multiple MCOs;</text> </paragraph> <paragraph num="(3)"> <text>Facilitate and confirm the selection of a primary care provider for an eligible newborn;</text> </paragraph> <paragraph num="(4)"> <text>Request an MCO ID card for a newborn when necessary;</text> </paragraph> <paragraph num="(5)"> <text>Make retroactive PCP enrollments when necessary;</text> </paragraph> <paragraph num="(6)"> <text>Facilitate the resolution of claims for services provided to an eligible newborn;</text> </paragraph> <paragraph num="(7)"> <text>Provide general guidance to providers and their office staff on newborn-related issues;</text> </paragraph> <paragraph num="(8)"> <text>Coordinate with ancillary care providers to facilitate appropriate delivery of care and payment of claims; and</text> </paragraph> <paragraph num="(9)"> <text>Coordinate and authorize in-network care when the newborn does not yet appear in EVS or the MCO's system, or out-of-network care when the MCO cannot offer an appropriate in-network provider.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 15-101, 15-102.3, and 15-103; Insurance Article, §§15-112, 15-605, and 15-1008; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.23 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.23 adopted effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulations .02C, .04C, .08, .11, .15, .17A, .18, .20B, and .22C amended and Regulation .11-1 adopted as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144); November 1, 1999 (26:22 Md. R. 1692); February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G and H amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03T adopted effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. 1838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective February 18, 2002 (29:3 Md. R.220); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 and .11-2 adopted February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 and .11-2E amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulations .11-1 and .11-2 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 9, 1998 (25:3 Md. R. 144); December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D, E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective February 9, 1998 (25:3 Md. R. 144); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective February 18, 2002 (29:3 Md. R.220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1 amended effective December 25, 2000 (27:25 Md. R.2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18-1C adopted effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); emergency status extended at 26:1 Md. R. 17, 26:6 Md. R. 480, and 26:8 Md. R. 614; emergency status expired May 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective December 25, 2000 (27:25 Md. R.2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931 and 29:4 Md. R. 413</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1—.19-3 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1—.19-4 adopted effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-1 and .19-2 repealed and new Regulation .19-1 adopted effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-1 repealed as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); repealed permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-3 and .19-4 amended and recodified to be new Regulations .19-2 and .19-3 effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-4 adopted effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulations .19-5 and.19-6 adopted as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931; emergency status extended at 29:4 Md. R. 413</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective December 25, 2000 (27:25 Md. R. 2281); December 24, 2001 (28:25 Md. R. 2190); July 7, 2003 (30:13 Md. R. 854)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; adopted permanently effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22A amended and F—J adopted effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulations .24 and .25 adopted as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective December 25, 2000 (27:25 Md. R.2281); December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24-1 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G, J, X amended effective November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02O, S amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02V amended effective December 27, 2010 (37:26 Md. R. 1787)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02Z adopted effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02CC amended effective October 5, 2009 (36:20 Md. R. 1528); March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02DD adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02EE adopted effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02K, L amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02FF adopted effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 12, 2018 (45:3 Md. R. 156)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective December 19, 2005 (32:25 Md. R. 1941); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787); February 6, 2012 (39:2 Md. R. 141); December 24, 2012 (39:25 Md. R. 1613); December 12, 2013 (40:24 Md. R. 2017); August 29, 2016 (43:17 Md. R. 955); November 7, 2016 (43:22 Md. R. 1221); December 31, 2018 (45:26 Md. R. 1245)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective April 10, 2006 (33:7 Md. R. 668); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05I amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05G amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05K amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C, E amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08I amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08K amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08M repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10D amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10E amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10F amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11F amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11G amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-2 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12D repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15C amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15E amended effective December 19, 2005 (32:25 Md. R. 1941); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15F amended effective April 10, 2006 (33:7 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15L adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 repealed effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180); February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18H amended effective November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18I, J adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended as an emergency provision effective April 1, 2005 (32:9 Md. R. 847); amended permanently effective July 18, 2005 (32:14 Md. R. 1276)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 15, 2013 (40:7 Md. R. 611)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A, B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); amended permanently effective June 16, 2008 (35:12 Md. R. 1120)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19A amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective December 20, 2004 (31:25 Md. R.1790); December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 669)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective July 1, 2006 (33:20 Md. R. 1610); amended permanently effective October 23, 2006 (33:21 Md. R. 1675)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective January 1, 2007 (34:4 Md. R. 396); amended permanently effective April 9, 2007 (34:7 Md. R. 699)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended as an emergency provision effective September 14, 2007 (34:21 Md. R. 1911); amended permanently effective November 19, 2007 (34:23 Md. R. 2027)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B amended effective January 12, 2009 (36:1 Md. R. 21); July 27, 2009 (36:15 Md. R. 1166); January 25, 2010 (37:2 Md. R. 67); June 14, 2010 (37:12 Md. R. 800); December 27, 2010 (37:26 Md. R. 1788); April 4, 2011 (37:8 Md. R. 431); April 30, 2012 (39:8 Md. R. 534); December 10, 2012 (39:24 Md. R. 1577); July 7, 2014 (41:13 Md. R. 752); February 16, 2015 (42:3 Md. R. 316); October 26, 2015 (42:21 Md. R. 1301); May 9, 2016 (43:9 Md. R. 530); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 446); amended permanently effective May 24, 2004 (31:10 Md. R. 795)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended effective June 14, 2010 (37:12 Md. R. 800); October 26, 2015 (42:21 Md. R. 1301); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 amended effective June 19, 2006 (33:12 Md. R. 997); April 9, 2007 (34:7 Md. R. 698); June 14, 2010 (37:12 Md. R. 800); April 30, 2012 (39:8 Md. R. 534)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 repealed effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3A, B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3A, B amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3B amended effective December 24, 2012 (39:25 Md. R. 1613); February 3, 2014 (41:2 Md. R. 91)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3C amended effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-3C, D amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5 adopted effective December 19, 2005 (32:25 Md. R. 1941)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5 repealed and new Regulation .19-5 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5F amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5G amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-5H amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective August 8, 2011 (38:16 Md. R. 945); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective April 10, 2006 (33:7 Md. R. 668); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, B amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, D amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B, C amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20E adopted effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21 amended effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21B amended effective June 19, 2006 (33:12 Md. R. 997); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22C, D amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23C amended effective November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23D amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23D amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 repealed effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.65 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective April 19, 2021 (48:8 Md. R. 309)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25B amended effective May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27C amended effective May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 18, 2021 (48:21 Md. R. 889)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 repealed and new Regulation .03-1 adopted effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2B amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2L adopted effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2L repealed and new Regulation .03-2 adopted effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2M adopted effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15E amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17B amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18K adopted effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective April 4, 2022 (49:7 Md. R. 468)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19B, D amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19D amended effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19E adopted effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-4A amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19-4M, N amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A, C amended effective June 24, 2024 (51:12 Md. R. 618)</annotation> </annotations> </chapter> <chapter num="05" heading="Maryland Medicaid Managed Care Program: Access"> <regulation prefix="Regulation" num=".01" heading="Access Standards: Addressing Enrollees' Individualized Needs."> <paragraph num="A."> <text>An MCO shall provide access to health care services and information in a manner that addresses the individualized needs of its enrollees, regardless of gender, sexual orientation, or gender identity, including, but not limited to, the delivery of services and information to enrollees:</text> <paragraph num="(1)"> <text>In a culturally sensitive manner;</text> </paragraph> <paragraph num="(2)"> <text>At an appropriate reading comprehension level;</text> </paragraph> <paragraph num="(3)"> <text>In the prevalent non-English languages identified by the State; and</text> </paragraph> <paragraph num="(4)"> <text>In a manner that accommodates individuals with disabilities consistent with the requirements of the Americans with Disabilities Act of 1990, P.L. 101-330, 42 U.S.C. §12101 et seq., and regulations promulgated under it.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Special Access.</text> <paragraph num="(1)"> <text>An MCO shall notify enrollees of the following services and make them available free of charge to the enrollee:</text> <paragraph num="(a)"> <text>Written materials in the prevalent non-English languages identified by the State;</text> </paragraph> <paragraph num="(b)"> <text>Written materials in alternative formats;</text> </paragraph> <paragraph num="(c)"> <text>Oral interpretation services in all non-English languages; and</text> </paragraph> <paragraph num="(d)"> <text>Auxiliary aids and services, such as:</text> <paragraph num="(i)"> <text>Teletypewriter/Telecommunication Device for the Deaf (TTY/TDD); and</text> </paragraph> <paragraph num="(ii)"> <text>American Sign Language.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO shall include taglines in the prevalent non-English languages identified by the State with its written materials critical to obtaining services that:</text> <paragraph num="(a)"> <text>Explain the availability of written translation or oral interpretation to understand the information provided; and</text> </paragraph> <paragraph num="(b)"> <text>Provide the toll-free and TTY/TDD telephone number of the MCO’s customer service unit.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Written Materials. An MCO shall provide all its written materials in the following manner:</text> <paragraph num="(1)"> <text>Using language and a format that is easily understood;</text> </paragraph> <paragraph num="(2)"> <text>In a font size no smaller than 12 point;</text> </paragraph> <paragraph num="(3)"> <text>Available in alternative formats and through the provision of auxiliary aids and services; and</text> </paragraph> <paragraph num="(4)"> <text>Available in an appropriate manner that takes into consideration the special needs of enrollees or potential enrollees with disabilities or limited English proficiency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO may provide enrollee information electronically so long as all of the following requirements are met:</text> <paragraph num="(1)"> <text>The format is readily accessible;</text> </paragraph> <paragraph num="(2)"> <text>The information is placed in a location on the MCO’s website that is prominent and readily accessible;</text> </paragraph> <paragraph num="(3)"> <text>The information is provided in an electronic form which can be electronically retained and printed;</text> </paragraph> <paragraph num="(4)"> <text>The information is consistent with the content and language requirements of this section;</text> </paragraph> <paragraph num="(5)"> <text>The enrollee is informed that the information is available in paper form without charge upon request; and</text> </paragraph> <paragraph num="(6)"> <text>Should the enrollee request it, the MCO provides the information in paper form within 5 business days.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Access Standards: Enrollee Handbook and Provider Directory."> <paragraph num="A."> <text>An MCO shall inform and educate its enrollees about:</text> <paragraph num="(1)"> <text>Basic information about the MCO;</text> </paragraph> <paragraph num="(2)"> <text>The availability of health care services and how to access them;</text> </paragraph> <paragraph num="(3)"> <text>The definitions of managed care terminology in accordance with 42 CFR 438.10(c)(4)(i); and</text> </paragraph> <paragraph num="(4)"> <text>Enrollee's rights and responsibilities in the MCO, and that the exercise of those rights does not adversely affect the way the MCO, its providers, or the Department treats the enrollee.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall, at the time of enrollment, and anytime upon request, furnish each enrollee with a copy of the MCOs enrollee handbook that includes all language in the template provided by the Department and the following current information:</text> <paragraph num="(1)"> <text>The enrollee's rights and responsibilities in the MCO as described in 42 CFR §438.100(b)(1), as amended;</text> </paragraph> <paragraph num="(2)"> <text>Information on how to access urgent care and emergency care services, including:</text> <paragraph num="(a)"> <text>What constitutes an emergency medical condition and emergency services;</text> </paragraph> <paragraph num="(b)"> <text>The following facts:</text> <paragraph num="(i)"> <text>Prior authorization is not required for these services; and</text> </paragraph> <paragraph num="(ii)"> <text>The enrollee has a right to use any hospital or other setting for emergency care;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The services included in the MCO's benefits package, including optional benefits provided by the MCO;</text> </paragraph> <paragraph num="(4)"> <text>How and where to access any benefits provided by the State, including any cost sharing, and how transportation is provided;</text> </paragraph> <paragraph num="(5)"> <text>The amount, duration, and scope of benefits available in sufficient detail to ensure that enrollees understand the benefits to which they are entitled;</text> </paragraph> <paragraph num="(6)"> <text>The availability of behavioral health services that are not included in the MCOs benefits package, and how to access these services;</text> </paragraph> <paragraph num="(7)"> <text>Information on the availability of self-referral services as well as any restrictions on the enrollee's freedom of choice among network providers;</text> </paragraph> <paragraph num="(8)"> <text>Information about how enrollees may obtain benefits from out-of-network providers;</text> </paragraph> <paragraph num="(9)"> <text>Any policies and procedures necessary to facilitate accessing needed services in compliance with the Maryland Medicaid Managed Care Program, including any requirements for service authorizations or referrals for specialty care and for other benefits not furnished by the enrollee's primary care provider;</text> </paragraph> <paragraph num="(10)"> <text>Information about the availability of EPSDT, prenatal care, family planning, and other wellness services, including education programs;</text> </paragraph> <paragraph num="(11)"> <text>A statement that the MCO cannot require an enrollee to obtain a referral before choosing a family planning provider;</text> </paragraph> <paragraph num="(12)"> <text>The process of selecting and changing the enrollee's primary care provider;</text> </paragraph> <paragraph num="(13)"> <text>A description of any benefits the MCO offers in addition to those required by the Maryland Medicaid Managed Care Program, including applicable terms and conditions for accessing those benefits;</text> </paragraph> <paragraph num="(14)"> <text>Information on how to access auxiliary aids and services, including additional information in alternative formats or languages;</text> </paragraph> <paragraph num="(15)"> <text>The toll-free telephone number for member services, medical management, and any other unit providing services directly to enrollees, including:</text> <paragraph num="(a)"> <text>A description of each unit and number;</text> </paragraph> <paragraph num="(b)"> <text>An explanation of how the phone numbers can be used to obtain information and assistance; and</text> </paragraph> <paragraph num="(c)"> <text>An explanation of the MCOs internal grievance procedure.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>Information regarding the importance of scheduling and maintaining appointments for preventive services;</text> </paragraph> <paragraph num="(17)"> <text>If applicable, a list of services that are not covered by the MCO because of moral or religious objections, and a statement that informs the enrollee that the State will provide information on how and where to obtain these services;</text> </paragraph> <paragraph num="(18)"> <text>The rule pertaining to poststabilization care services, as set forth in Regulation .08G of this chapter;</text> </paragraph> <paragraph num="(19)"> <text>Appeal, grievance, and fair hearing procedures and time frames that include the following:</text> <paragraph num="(a)"> <text>The right to a State fair hearing, including the method for obtaining a hearing and the rules that govern representation at the hearing;</text> </paragraph> <paragraph num="(b)"> <text>The right to file appeals and grievances;</text> </paragraph> <paragraph num="(c)"> <text>The requirements and time frames for filing an appeal or grievance;</text> </paragraph> <paragraph num="(d)"> <text>The availability of assistance in the filing process;</text> </paragraph> <paragraph num="(e)"> <text>The toll-free numbers that the enrollee may use to file an appeal or grievance by phone;</text> </paragraph> <paragraph num="(f)"> <text>The fact that, if requested by the enrollee, the benefits will continue if the enrollee files an appeal or a request for a State fair hearing within the time frames specified for filing; and</text> </paragraph> <paragraph num="(g)"> <text>That the enrollee may be required to pay the cost of the services furnished while the appeal is pending, if the final decision is adverse to the enrollee;</text> </paragraph> </paragraph> <paragraph num="(20)"> <text>Any appeal rights the State chooses to make available to providers;</text> </paragraph> <paragraph num="(21)"> <text>Advanced directives as set forth in 42 CFR §438.3(j)(1), as amended;</text> </paragraph> <paragraph num="(22)"> <text>Information on how to report suspected fraud or abuse;</text> </paragraph> <paragraph num="(23)"> <text>Additional information that is available upon request, including the following:</text> <paragraph num="(a)"> <text>Information on the structure and operation of the MCO; and</text> </paragraph> <paragraph num="(b)"> <text>Physician incentive plans.</text> </paragraph> </paragraph> <paragraph num="(24)"> <text>Information on how to access or obtain the MCOs provider directory.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provider Directory.</text> <paragraph num="(1)"> <text>An MCO shall provide enrollees with information regarding their provider networks including:</text> <paragraph num="(a)"> <text>Its primary care service locations;</text> </paragraph> <paragraph num="(b)"> <text>A listing of the MCOs hospital providers, of both inpatient and outpatient services, in the enrollee's county, their addresses, and services provided;</text> </paragraph> <paragraph num="(c)"> <text>A listing of the MCOs pharmacy providers in the enrollee's county and their addresses; and</text> </paragraph> <paragraph num="(d)"> <text>A listing of the individual practitioners who are the MCOs primary and specialty care providers in the enrollee's county, grouped by medical specialty, giving:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Practice location or locations;</text> </paragraph> <paragraph num="(iv)"> <text>Telephone number or numbers;</text> </paragraph> <paragraph num="(v)"> <text>Website URL, as appropriate;</text> </paragraph> <paragraph num="(vi)"> <text>Any group affiliation, as appropriate;</text> </paragraph> <paragraph num="(vii)"> <text>Cultural and linguistic capabilities, including languages offered by the provider or a skilled medical interpreter at the provider’s offices, American Sign Language interpretation;</text> </paragraph> <paragraph num="(viii)"> <text>An indication of whether the provider's office or facility has accommodations for physical disabilities, including offices, exam room or rooms and equipment;</text> </paragraph> <paragraph num="(ix)"> <text>An indication of whether or not the provider is accepting new patients;</text> </paragraph> <paragraph num="(x)"> <text>An indication of the age range of patients accepted or whether there is no age limit; and</text> </paragraph> <paragraph num="(xi)"> <text>If applicable, how access to the provider is otherwise limited.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Upon request by an enrollee, an MCO shall furnish a paper copy of the provider directory.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO shall notify all enrollees of their right to request and obtain the information listed in §§B and C of this regulation at least once a year.</text> </paragraph> <paragraph num="E."> <text>The Department may consider the information listed in §§B and C of this regulation to be provided if the MCO:</text> <paragraph num="(1)"> <text>Mails a printed copy of the information to the enrollee's mailing address;</text> </paragraph> <paragraph num="(2)"> <text>Provides the information by email after obtaining the enrollee's agreement to receive the information by email;</text> </paragraph> <paragraph num="(3)"> <text>Posts the information on the MCOs website and advises the enrollee in paper or electronic form that the information is available on the internet and includes the applicable internet address, provided that enrollees with disabilities who cannot access this information online are provided auxiliary aids and services upon request at no cost; or</text> </paragraph> <paragraph num="(4)"> <text>Provides the information by any other method that can reasonably be expected to result in the enrollee receiving that information.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An MCO shall update its online provider directory no later than 30 days after the MCO receives updated provider information.</text> </paragraph> <paragraph num="G."> <text>An MCO shall update its paper directory:</text> <paragraph num="(1)"> <text>Monthly if the MCO does not have a mobile-enabled electronic directory; or</text> </paragraph> <paragraph num="(2)"> <text>Quarterly if the MCO has a mobile-enabled electronic directory.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An MCO shall make provider directories available on its website in a machine-readable file and format as specified by the Secretary for the U.S. Department of Health and Human Services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Access Standards: Outreach."> <paragraph num="A."> <text>An MCO is responsible for delivering needed health care services even when the enrollee is difficult to reach or misses appointments.</text> </paragraph> <paragraph num="B."> <text>The assistance of local health departments in contacting and bringing into care enrollees who are difficult to reach or miss appointments is available for the specific categories of enrollees identified in this regulation, but only after the MCO has made documented attempts to contact and bring into care an enrollee who is difficult to reach or misses appointments before seeking the assistance of the local health department.</text> </paragraph> <paragraph num="C."> <text>Adults.</text> <paragraph num="(1)"> <text>An MCO shall, before referring the enrollee to the local health department, make documented attempts to ensure that follow-up appointments are scheduled in accordance with the enrollee's treatment plan by attempting a variety of contact methods, which may include:</text> <paragraph num="(a)"> <text>Written correspondence;</text> </paragraph> <paragraph num="(b)"> <text>Telephone contact; and</text> </paragraph> <paragraph num="(c)"> <text>Face-to-face contact.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the enrollee, due to impaired cognitive ability or psychosocial problems such as homelessness or other conditions, can be expected to have difficulty understanding the importance of treatment instructions or difficulty navigating the health care system, the MCO shall, after exhausting its best efforts to contact and bring into care the enrollee in accordance with §C(1) of this regulation, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance within 10 business days of whichever first occurs:</text> <paragraph num="(a)"> <text>The third consecutive missed appointment; or</text> </paragraph> <paragraph num="(b)"> <text>The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Child Younger than 2 Years Old Needing EPSDT Screening Services.</text> <paragraph num="(1)"> <text>An MCO shall ensure that appointments are scheduled in accordance with the EPSDT periodicity schedule or within 30 days of the MCO's receipt of the health risk assessment, whichever is less.</text> </paragraph> <paragraph num="(2)"> <text>If the enrollee fails to keep the appointment, the MCO shall ensure that a second appointment is scheduled within 30 days.</text> </paragraph> <paragraph num="(3)"> <text>If the enrollee misses the second appointment, a third appointment shall be scheduled within 30 days.</text> </paragraph> <paragraph num="(4)"> <text>For each scheduled appointment, the MCO shall:</text> <paragraph num="(a)"> <text>Provide written notice to the enrollee's parent, guardian, or caretaker of the appointment dates; and</text> </paragraph> <paragraph num="(b)"> <text>Attempt to notify the enrollee's parent, guardian, or caretaker of the appointment dates by telephone.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the enrollee misses the second appointment in a row, after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care.</text> </paragraph> <paragraph num="(6)"> <text>After referral to the local health department, the MCO shall continue to work collaboratively with the local health department to bring the enrollee into care until the enrollee comes back into compliance with the EPSDT periodicity schedule.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Child Younger than 21 Years Old Needing Follow-up Treatment.</text> <paragraph num="(1)"> <text>An MCO shall ensure that an appointment for follow-up care is scheduled at a time interval appropriate to the enrollee's diagnosed condition.</text> </paragraph> <paragraph num="(2)"> <text>If the enrollee fails to keep the appointment, the MCO shall reschedule the appointment for the enrollee to be seen within 30 days.</text> </paragraph> <paragraph num="(3)"> <text>For each scheduled appointment, the MCO shall:</text> <paragraph num="(a)"> <text>Provide written notice to the enrollee, or to the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by mail; and</text> </paragraph> <paragraph num="(b)"> <text>Attempt to notify the enrollee, or the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by telephone.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If the enrollee misses the second consecutive follow-up appointment after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care.</text> </paragraph> <paragraph num="(5)"> <text>After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the enrollee into care.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Pregnant or Postpartum Woman Needing Prenatal or Postpartum Care.</text> <paragraph num="(1)"> <text>Initial Visit. An MCO shall schedule an initial visit for the pregnant or postpartum enrollee to be seen within 10 days of her request for an appointment. If she fails to appear for the appointment, the MCO shall reschedule in a timely manner appropriate to her medical condition.</text> </paragraph> <paragraph num="(2)"> <text>Follow-Up Appointments. After the enrollee has completed an initial visit that includes a comprehensive history, physical exam, and completion of the Maryland Prenatal Risk Assessment, the MCO shall ensure that appointments are scheduled for the enrollee in compliance with the periodicity schedule of the ACOG guidelines. If the enrollee fails to appear for a scheduled appointment, the MCO shall ensure that the appointment is rescheduled for the enrollee to be seen within 10 days.</text> </paragraph> <paragraph num="(3)"> <text>For each scheduled appointment, the MCO shall:</text> <paragraph num="(a)"> <text>Provide written notice to the enrollee of the appointment dates; and</text> </paragraph> <paragraph num="(b)"> <text>Attempt to notify the enrollee of the appointment dates by telephone.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>After making the attempts specified in §F(3) of this regulation, if the MCO is unable to bring the enrollee into care within 30 days of the first missed appointment, the MCO shall, within 10 days of the last missed appointment, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care.</text> </paragraph> <paragraph num="(5)"> <text>After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the patient into care, until the enrollee comes back in compliance with the ACOG periodicity schedule.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Access Standards: Information for Providers."> <paragraph num="A."> <text>An MCO shall develop and make available either electronically or by hard copy to all of its PCP and specialty care providers a Medicaid requirements manual, including periodic updates as appropriate, and shall:</text> <paragraph num="(1)"> <text>Before distribution, file a copy of its manual with the Department for review;</text> </paragraph> <paragraph num="(2)"> <text>Include in its manual the information necessary to facilitate the providers’ full compliance with federal and State Medicaid requirements, including information on:</text> <paragraph num="(a)"> <text>Medicaid statutes and regulations;</text> </paragraph> <paragraph num="(b)"> <text>The benefits package, including optional benefits;</text> </paragraph> <paragraph num="(c)"> <text>Access requirements, which, at a minimum, comply with the requirements of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Quality requirements, which shall, at a minimum, comply with the requirements of COMAR 10.67.04.03;</text> </paragraph> <paragraph num="(e)"> <text>Continuity of care requirements;</text> </paragraph> <paragraph num="(f)"> <text>Requirements for referral to specialist, ancillary, and other providers as necessary to provide the full range of medically necessary services that are covered by the Maryland Medicaid Managed Care Program; and</text> </paragraph> <paragraph num="(g)"> <text>The MCO’s practice guidelines as described in 42 CFR §438.236.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Inform the MCO’s primary and specialty care providers of their responsibility to provide or arrange for medically necessary accessible health care services that are continuous, comprehensive, and coordinated for each enrollee, including:</text> <paragraph num="(a)"> <text>Preventive health services;</text> </paragraph> <paragraph num="(b)"> <text>Primary acute medical care;</text> </paragraph> <paragraph num="(c)"> <text>Chronic medical care;</text> </paragraph> <paragraph num="(d)"> <text>Consultation, referral, and follow-up in areas including medical specialties and child dental care;</text> </paragraph> <paragraph num="(e)"> <text>Referral for ancillary and support-related services including but not limited to:</text> <paragraph num="(i)"> <text>Drug therapies;</text> </paragraph> <paragraph num="(ii)"> <text>Diagnostic tests;</text> </paragraph> <paragraph num="(iii)"> <text>Medical supplies;</text> </paragraph> <paragraph num="(iv)"> <text>Durable medical equipment; and</text> </paragraph> <paragraph num="(v)"> <text>Case management when appropriate for complex conditions;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>24-hour per day, 7-day per week provider coverage for medically necessary services;</text> </paragraph> <paragraph num="(g)"> <text>Maintenance of a medical record, including records of referral arrangements and outcomes of those referrals; and</text> </paragraph> <paragraph num="(h)"> <text>Detection of mental health problems or substance use disorder during routine or follow-up screening, to be treated either through the MCO or referred to the behavioral health ASO for services; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Inform the providers of the following enrollee appeal, grievance, and fair hearing procedures and time frames:</text> <paragraph num="(a)"> <text>The enrollee's right to a State fair hearing, how to obtain a hearing, and representation rules at a hearing;</text> </paragraph> <paragraph num="(b)"> <text>The enrollee's right to file appeals and grievances, and the enrollee's requirements and time frames for filing;</text> </paragraph> <paragraph num="(c)"> <text>The availability of assistance in filing;</text> </paragraph> <paragraph num="(d)"> <text>The toll-free numbers to file verbal appeals and grievances;</text> </paragraph> <paragraph num="(e)"> <text>The enrollee's right to request continuation of benefits during an appeal or State fair hearing filing, and that if the MCO action is upheld in a hearing, the enrollee may be liable for the cost of any continued benefits; and</text> </paragraph> <paragraph num="(f)"> <text>The provider's right to appeal, on the enrollee's behalf, the failure of the MCO to cover a service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall ensure that its PCP and specialty care providers receive adequate information regarding the Medicaid Program to facilitate full compliance with all federal and State Medicaid requirements. The MCO shall:</text> <paragraph num="(1)"> <text>Ensure that each PCP and specialty care provider receives, at the time they enter into a contract, a copy of the MCO's Medicaid requirements manual, and any other pertinent information; and</text> </paragraph> <paragraph num="(2)"> <text>Provide each PCP and specialty care provider, on an ongoing basis as appropriate, with periodic updates of the materials required to be provided under §B(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall provide to each PCP an updated list of the PCP’s assigned enrollees monthly.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Access Standards: PCPs and MCO's Provider Network."> <paragraph num="A."> <text>Primary Care Provider (PCP).</text> <paragraph num="(1)"> <text>An MCO shall assign each enrollee to a primary care provider who is:</text> <paragraph num="(a)"> <text>Chosen by the enrollee from the MCO's panel of qualified providers; or</text> </paragraph> <paragraph num="(b)"> <text>Chosen by the MCO from its panel of qualified providers if the enrollee has failed to choose a PCP.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An enrollee may request a change of PCP at any time if the PCP is within the recipient's current MCO's panel of providers.</text> </paragraph> <paragraph num="(3)"> <text>With respect to enrollees younger than 21 years old, an MCO shall assign the enrollee to a PCP who is certified by the EPSDT program, unless the enrollee or the enrollee's parent, guardian, or caretaker, as appropriate, specifically requests assignment to a PCP who is not EPSDT-certified.</text> </paragraph> <paragraph num="(4)"> <text>If the enrollee’s parent, guardian, or caretaker, as appropriate, chooses a non-EPSDT certified PCP in accordance to §A(3) of this regulation, within 30 days of enrollment, the MCO shall:</text> <paragraph num="(a)"> <text>Notify the parent, guardian, or caretaker, by letter, that a non-EPSDT certified PCP has been chosen; and</text> </paragraph> <paragraph num="(b)"> <text>Include in the notification an explanation of the:</text> <paragraph num="(i)"> <text>EPSDT preventive screening services to which an enrollee is entitled according to the EPSDT periodicity schedule;</text> </paragraph> <paragraph num="(ii)"> <text>Importance of accessing the EPSDT preventive screening services; and</text> </paragraph> <paragraph num="(iii)"> <text>Process for requesting a change to an EPSDT-certified PCP to obtain preventive screening services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>An MCO may include, as appropriate, any of the following practitioners to serve as the primary care provider for an enrollee:</text> <paragraph num="(a)"> <text>General practitioner;</text> </paragraph> <paragraph num="(b)"> <text>Family practitioner;</text> </paragraph> <paragraph num="(c)"> <text>Internist;</text> </paragraph> <paragraph num="(d)"> <text>Pediatrician;</text> </paragraph> <paragraph num="(e)"> <text>OB/GYN;</text> </paragraph> <paragraph num="(f)"> <text>Physician assistant;</text> </paragraph> <paragraph num="(g)"> <text>Certified nurse midwife;</text> </paragraph> <paragraph num="(h)"> <text>Nurse practitioner certified in any of the following areas of specialization:</text> <paragraph num="(i)"> <text>Adult;</text> </paragraph> <paragraph num="(ii)"> <text>Pediatric;</text> </paragraph> <paragraph num="(iii)"> <text>Geriatric;</text> </paragraph> <paragraph num="(iv)"> <text>OB/GYN;</text> </paragraph> <paragraph num="(v)"> <text>School nurse; or</text> </paragraph> <paragraph num="(vi)"> <text>Family; and</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>A physician practicing in a specialty area other than those enumerated in §A(5)(b)—(e) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>The enrollee's designated primary care provider (PCP) is the enrollee's primary coordinator of care.</text> </paragraph> <paragraph num="(7)"> <text>For female enrollees, if the enrollee's PCP is not a women's health specialist, the MCO shall provide direct access, without the need for a referral, to a women's health specialist within the MCO's network for covered services necessary to provide women's routine and preventive health care services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Adequacy of Provider Network.</text> <paragraph num="(1)"> <text>An MCO shall develop and maintain a complete network of adult and pediatric primary care, specialty care, ancillary service, vision, pharmacy, home health, and any other providers adequate to deliver the full scope of benefits as required by this chapter and COMAR 10.67.06.</text> </paragraph> <paragraph num="(2)"> <text>An MCO shall clearly define and specify referral requirements to specialty and other providers.</text> </paragraph> <paragraph num="(3)"> <text>An MCO shall require the PCP to maintain records of referral arrangements, and the feedback and outcomes of those referrals, within each enrollee's medical records.</text> </paragraph> <paragraph num="(4)"> <text>An MCO shall maintain a list of its proposed and existing subcontracts with health care providers who are necessary to fulfill the MCO's service delivery obligations.</text> </paragraph> <paragraph num="(5)"> <text>An MCO shall provide a list of its subcontractor providers to the Department.</text> </paragraph> <paragraph num="(6)"> <text>An MCO shall ensure services are delivered in a culturally competent manner to all enrollees, including enrollees:</text> <paragraph num="(a)"> <text>With limited English proficiency;</text> </paragraph> <paragraph num="(b)"> <text>With diverse cultural and ethnic backgrounds; and</text> </paragraph> <paragraph num="(c)"> <text>Of all genders, sexual orientations, and gender identities.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>For enrollees with physical or mental disabilities, an MCO shall ensure its network providers provide:</text> <paragraph num="(a)"> <text>Physical access;</text> </paragraph> <paragraph num="(b)"> <text>Reasonable accommodation; and</text> </paragraph> <paragraph num="(c)"> <text>Accessible equipment.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Capacity.</text> <paragraph num="(a)"> <text>MCOs shall ensure adequate capacity and services, in compliance with 42 CFR §438.206(b)(1)(i), as amended.</text> </paragraph> <paragraph num="(b)"> <text>The Department shall assess the MCO's provider network and determine its capacity to serve waiver-eligible recipients in each local access area in its service area.</text> </paragraph> <paragraph num="(c)"> <text>Unless the MCO can establish to the Department's satisfaction the adequacy of a higher ratio, the Department shall determine the MCO's capacity with respect to any local access area by assuming that in-plan individual practitioners, based on full-time equivalency, will be assigned no more than the number of enrollees that is consistent with a 200:1 ratio of enrollee to practitioner in the local access area.</text> </paragraph> <paragraph num="(d)"> <text>The Department may not approve an enrollee-to-PCP ratio that is higher than 2,000:1.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>To ensure compliance with the timely access requirements in Regulation .07 of this chapter, an MCO shall:</text> <paragraph num="(a)"> <text>Establish mechanisms to ensure that network providers comply with access requirements;</text> </paragraph> <paragraph num="(b)"> <text>Monitor regularly to determine compliance; and</text> </paragraph> <paragraph num="(c)"> <text>Take corrective action if there is a failure to comply.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05-1" heading="Access Standards: Specialty Provider Network."> <paragraph num="A."> <text>Standards and Regions.</text> <paragraph num="(1)"> <text>The Department shall review an MCOs specialty provider network for MCOs overall network as defined in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Overall Network Standards.</text> <paragraph num="(a)"> <text>An MCO shall meet either the time or distance standard set forth in Regulation .06A of this chapter for core, major, and pediatric specialties.</text> </paragraph> <paragraph num="(b)"> <text>The nine core specialties are:</text> <paragraph num="(i)"> <text>Cardiology;</text> </paragraph> <paragraph num="(ii)"> <text>Otolaryngology (ENT);</text> </paragraph> <paragraph num="(iii)"> <text>Gastroenterology;</text> </paragraph> <paragraph num="(iv)"> <text>Neurology;</text> </paragraph> <paragraph num="(v)"> <text>Oncology;</text> </paragraph> <paragraph num="(vi)"> <text>Ophthalmology;</text> </paragraph> <paragraph num="(vii)"> <text>Orthopedics;</text> </paragraph> <paragraph num="(viii)"> <text>Surgery; and</text> </paragraph> <paragraph num="(ix)"> <text>Urology.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The 6 major specialties are:</text> <paragraph num="(i)"> <text>Allergy and immunology;</text> </paragraph> <paragraph num="(ii)"> <text>Dermatology;</text> </paragraph> <paragraph num="(iii)"> <text>Endocrinology;</text> </paragraph> <paragraph num="(iv)"> <text>Infectious disease;</text> </paragraph> <paragraph num="(v)"> <text>Nephrology; and</text> </paragraph> <paragraph num="(vi)"> <text>Pulmonology.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The 4 pediatric subspecialties are:</text> <paragraph num="(i)"> <text>Cardiology;</text> </paragraph> <paragraph num="(ii)"> <text>Gastroenterology;</text> </paragraph> <paragraph num="(iii)"> <text>Neurology; and</text> </paragraph> <paragraph num="(iv)"> <text>Surgery.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If the Department determines that an MCO does not meet the requirements specified in §A(2)(b)(d) of this regulation, the MCO may provide additional information to support the adequacy of the MCO's specialty network before any action is taken by the Department.</text> </paragraph> <paragraph num="C."> <text>If an MCO fails to meet the requirements established by this regulation, the Department may suspend the automatic assignment to the MCO of recipients who live in the affected local access area.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Geographical Access."> <paragraph num="A."> <text>Except as provided in §C of this regulation, an MCO shall develop and maintain a provider network that meets the following time and distance standards:</text> <paragraph num="(1)"> <text>For adult and pediatric primary care, pharmacy, diagnostic laboratory and x-ray, and gynecology:</text> <paragraph num="(a)"> <text>In urban areas, within 15 minutes or 10 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 30 minutes or 20 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 40 minutes or 30 miles;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For prenatal care, as defined in §B of this regulation:</text> <paragraph num="(a)"> <text>In urban areas, within 15 minutes or 10 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 30 minutes or 20 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 90 minutes or 75 miles;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For acute inpatient hospitals:</text> <paragraph num="(a)"> <text>In urban areas, within 20 minutes or 10 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 45 minutes or 30 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 75 minutes or 60 miles;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>For core specialty types, as defined in Regulation .05-1A(2)(b) of this chapter:</text> <paragraph num="(a)"> <text>In urban areas, within 30 minutes or 15 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 60 minutes or 45 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 90 minutes or 75 miles;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For major specialty types, as defined in Regulation .05-1A(2)(c) of this chapter:</text> <paragraph num="(a)"> <text>In urban areas, within 30 minutes or 15 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 80 minutes or 60 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 110 minutes or 90 miles; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>For pediatric subspecialty types, as defined in Regulation .05-1A(2)(d) of this chapter:</text> <paragraph num="(a)"> <text>In urban areas, within 30 minutes or 15 miles;</text> </paragraph> <paragraph num="(b)"> <text>In suburban areas, within 80 minutes or 60 miles; and</text> </paragraph> <paragraph num="(c)"> <text>In rural areas, within 250 minutes or 200 miles.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Prenatal Care Providers. For the purposes of provider network adequacy, prenatal care providers may include, but are not limited to:</text> <paragraph num="(1)"> <text>Obstetricians;</text> </paragraph> <paragraph num="(2)"> <text>Certified nurse midwives; and</text> </paragraph> <paragraph num="(3)"> <text>Family practitioners who provide prenatal care and perform deliveries.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an MCO can otherwise demonstrate to the Department's satisfaction the adequacy of its provider network notwithstanding its inability to meet the requirements of §A of this regulation, the Department may, in its discretion, approve the network if special circumstances exist which, considered along with the overall strength of the MCO's network, establish that the Department's approval of the network will enhance recipients' overall access to quality health care services in the area to be served.</text> </paragraph> <paragraph num="D."> <text>Geographical Access: Local Access Areas.</text> </paragraph> <paragraph num="E."> <text>For purposes of this regulation:</text> <paragraph num="(1)"> <text>Urban enrollment area includes Baltimore City;</text> </paragraph> <paragraph num="(2)"> <text>Rural enrollment counties include:</text> <paragraph num="(a)"> <text>Allegany;</text> </paragraph> <paragraph num="(b)"> <text>Calvert;</text> </paragraph> <paragraph num="(c)"> <text>Caroline;</text> </paragraph> <paragraph num="(d)"> <text>Cecil;</text> </paragraph> <paragraph num="(e)"> <text>Charles;</text> </paragraph> <paragraph num="(f)"> <text>Dorchester;</text> </paragraph> <paragraph num="(g)"> <text>Frederick;</text> </paragraph> <paragraph num="(h)"> <text>Garrett;</text> </paragraph> <paragraph num="(i)"> <text>Kent;</text> </paragraph> <paragraph num="(j)"> <text>Queen Anne's;</text> </paragraph> <paragraph num="(k)"> <text>Saint Mary's;</text> </paragraph> <paragraph num="(l)"> <text>Somerset;</text> </paragraph> <paragraph num="(m)"> <text>Talbot;</text> </paragraph> <paragraph num="(n)"> <text>Washington;</text> </paragraph> <paragraph num="(o)"> <text>Wicomico; and</text> </paragraph> <paragraph num="(p)"> <text>Worcester; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Suburban enrollment counties include:</text> <paragraph num="(a)"> <text>Baltimore County;</text> </paragraph> <paragraph num="(b)"> <text>Anne Arundel;</text> </paragraph> <paragraph num="(c)"> <text>Carroll;</text> </paragraph> <paragraph num="(d)"> <text>Harford;</text> </paragraph> <paragraph num="(e)"> <text>Howard;</text> </paragraph> <paragraph num="(f)"> <text>Montgomery; and</text> </paragraph> <paragraph num="(g)"> <text>Prince George’s.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Access Standards: Clinical and Pharmacy Access."> <paragraph num="A."> <text>Appointments.</text> <paragraph num="(1)"> <text>New Enrollees: Initial Appointment.</text> <paragraph num="(a)"> <text>On its receipt and review of the health service needs information of a new enrollee, an MCO shall take appropriate action to ensure that the new enrollee who needs special or immediate health care services, as identified by the health service needs information, receives them in a timely manner.</text> </paragraph> <paragraph num="(b)"> <text>Unless the new enrollee is assigned to a PCP who was the enrollee’s established provider of care immediately before the enrollee’s enrollment, and, consistent with any applicable periodicity schedule, the PCP concludes that no immediate initial appointment is necessary:</text> <paragraph num="(i)"> <text>Unless a shorter time frame otherwise applies, the MCO shall ensure that a new enrollee's initial appointment is scheduled to occur within 90 days of the date of enrollment;</text> </paragraph> <paragraph num="(ii)"> <text>Unless the PCP confirms that the enrollee has elected to continue prenatal care with her established provider pursuant to COMAR 10.67.06.28C, the MCO shall ensure that an initial prenatal appointment is scheduled to occur within 10 days of the date that the MCO receives the enrollee's completed health risk assessment, or within 10 days of the enrollee's request for an appointment, whichever is sooner;</text> </paragraph> <paragraph num="(iii)"> <text>If the new enrollee is a person requesting family planning services, the MCO shall ensure that an initial appointment is scheduled to occur within 10 days of the date of the enrollee's request for an appointment; or</text> </paragraph> <paragraph num="(iv)"> <text>If the new enrollee is identified to be at high risk by the health service needs information form, the MCO shall ensure that an initial appointment is scheduled to occur within 15 business days of the MCO’s receipt of the enrollee’s completed health risk assessment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Required Notice to Enrollees of Wellness Services.</text> <paragraph num="(a)"> <text>An MCO shall notify its enrollees in writing of their due dates for obtaining wellness services, including but not limited to immunizations and examinations, in a timely manner.</text> </paragraph> <paragraph num="(b)"> <text>An MCO shall perform the notice required in §A(2)(a) of this regulation within 90 days of a new enrollee's enrollment.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Appointment Guidelines.</text> <paragraph num="(a)"> <text>An MCO shall develop specific guidelines that define how requests for appointments are arranged, which shall include a policy that:</text> <paragraph num="(i)"> <text>On request, all family members needing appointments will be given appointment times that are approximately concurrent or consecutive, whenever practicable, to facilitate the enrollees' transportation to and from their appointments; and</text> </paragraph> <paragraph num="(ii)"> <text>When needed, enrollees will be afforded assistance in securing transportation to and from appointments, which shall include, when appropriate, contacting the local transportation grantee agency on behalf of the enrollee for the purpose of securing the enrollee's access to these services.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An MCO shall have procedures that result in an interval between the enrollee's request for an appointment and the actual appointment time being consistent with the following standards:</text> <paragraph num="(i)"> <text>When §A(3)(b)(i) of this regulation does not apply, well-child assessments shall be scheduled to be completed within 30 days of the request for an appointment;</text> </paragraph> <paragraph num="(ii)"> <text>Initial assessments of pregnant and postpartum women and individuals requesting family planning services shall be scheduled to be completed within 10 business days of the request for an appointment;</text> </paragraph> <paragraph num="(iii)"> <text>Individuals requesting urgent care shall be scheduled to be seen within 48 hours of the request;</text> </paragraph> <paragraph num="(iv)"> <text>Requests for routine and preventative primary care appointments shall be scheduled to be performed within 30 days of the request;</text> </paragraph> <paragraph num="(v)"> <text>Requests for routine specialist follow-up appointments shall be scheduled to be performed within 30 days of the initial authorization from the enrollee's primary care provider, or sooner as deemed necessary by the primary care provider, whose office staff shall make the appointment directly with the specialist's office;</text> </paragraph> <paragraph num="(vi)"> <text>At the discretion of the newborn's PCP, the initial visit for newborns shall be scheduled to be performed within 14 days of discharge from the hospital if no home visit has occurred;</text> </paragraph> <paragraph num="(vii)"> <text>If a home visit has been provided, the initial visit for newborns shall be scheduled to be performed, at the discretion of the newborn's PCP, within 30 days of discharge from the hospital; and</text> </paragraph> <paragraph num="(viii)"> <text>Requests for regular optometry, lab, and X-ray appointments shall be scheduled to be performed within 30 days of the request, and within 48 hours of the request for urgent care.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall respond in a timely manner to its enrollees' needs and requests, as follows:</text> <paragraph num="(1)"> <text>If the enrollee arrives early or on time for a scheduled appointment, waiting time to be seen for a regular office visit may not exceed 1 hour after the scheduled appointment time;</text> </paragraph> <paragraph num="(2)"> <text>An MCO representative may not leave an enrollee's telephone call on hold for more than 10 minutes; and</text> </paragraph> <paragraph num="(3)"> <text>An MCO representative shall respond to patient inquiries as to whether or not to use emergency facilities within 30 minutes.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Hours of Access for Clinical Services.</text> <paragraph num="(1)"> <text>An MCO shall establish, or require its subcontractors to establish, a reasonable schedule of operating hours during which its service delivery sites are open to the MCO's enrollees as follows:</text> <paragraph num="(a)"> <text>For the MCO's employee and subcontractor providers who are individual practitioners, operating hours shall be at least 20 hours per week and at least 3 days per week;</text> </paragraph> <paragraph num="(b)"> <text>For subcontractors who have contracted with the MCO as a group practice or facility, the operating hours shall be at least 35 hours per week;</text> </paragraph> <paragraph num="(c)"> <text>The distribution of the hours of service shall be consistent with enrollee utilization patterns, but is otherwise at the discretion of the MCO or its subcontractor; and</text> </paragraph> <paragraph num="(d)"> <text>The operating hours may not be less than:</text> <paragraph num="(i)"> <text>The hours of operation offered to commercial enrollees; or</text> </paragraph> <paragraph num="(ii)"> <text>The hours of operation offered to Medicaid fee-for-service, if the provider serves only Medicaid enrollees.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Hours of Access for Pharmacy Services.</text> <paragraph num="(a)"> <text>An MCO shall establish reasonable hours of access to pharmacy services, including weekend and evening hours, which are equivalent to the hours pharmacy services are generally available in the local access area to the public at large.</text> </paragraph> <paragraph num="(b)"> <text>If the MCO determines that weekend and evening pharmacy hours are not generally available in the local access area, it may request approval from the Department to offer only limited pharmacy hours as specified in §C(2)(c) of this regulation.</text> </paragraph> <paragraph num="(c)"> <text>To seek approval to offer limited pharmacy hours, an MCO shall make its request for approval to the Department, and shall include the following:</text> <paragraph num="(i)"> <text>A specification of the geographical areas where the MCO intends to have limited pharmacy hours;</text> </paragraph> <paragraph num="(ii)"> <text>An explanation of why only limited pharmacy hours are available in these areas; and</text> </paragraph> <paragraph num="(iii)"> <text>An identification of where its enrollees would have to go to secure prescriptions in the evenings and on weekends.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Except as permitted in §C(2)(e) of this regulation, an MCO shall ensure that an enrollee receives at the time the prescription is dispensed to the enrollee any medically necessary disposable medical supplies or durable medical equipment needed by the enrollee to administer or monitor the enrollee's prescriptions.</text> </paragraph> <paragraph num="(e)"> <text>An MCO shall ensure that any disposable supplies or durable medical equipment necessary to administer or monitor an enrollee's prescriptions, if not available at the pharmacy at the time of the dispensing of the prescription, is received in a manner so as not to adversely affect the health of the enrollee, but not later than 24 hours.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical Access Outside the MCO's Service Area.</text> <paragraph num="(1)"> <text>Subject to §D(2) of this regulation, an MCO shall be financially responsible for medically necessary emergency services delivered to its enrollees outside of the MCO's service area.</text> </paragraph> <paragraph num="(2)"> <text>With the exception of emergency services, an MCO may require authorization before treatment for services delivered to its enrollees outside of the MCO's service area.</text> </paragraph> <paragraph num="(3)"> <text>If the MCO’s provider network is unable to provide necessary services, covered under the contract, to an enrollee, the MCO shall adequately and timely cover these services out of network for as long as the MCO’s provider network is unable to provide them.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may not impose any fines or other sanctions against an MCO for failure to comply with the waiting time standards in §B of this regulation unless there is evidence of a pattern of repeated violations by the MCO.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Emergency Services Access."> <paragraph num="A."> <text>An MCO shall develop and maintain policies and procedures for the adequate provision of emergency services for all its enrollees, including:</text> <paragraph num="(1)"> <text>Instituting and monitoring a system for responding to enrollees' emergency medical conditions, with provisions for immediate attention to and appropriate disposition of emergency calls; and</text> </paragraph> <paragraph num="(2)"> <text>Informing and educating its enrollees in the procedures to be followed in the event of an emergency, whether within or outside of the MCO's service area.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall provide medically necessary emergency services 24 hours per day, 7 days per week.</text> </paragraph> <paragraph num="C."> <text>An MCO shall maintain an emergency telephone service, with a physician on call, for the purpose of rendering medical advice and authorizing care at other facilities when use of the MCO's own facilities is impractical.</text> </paragraph> <paragraph num="D."> <text>An MCO may provide emergency services access through adequate and appropriate triage assessments performed by qualified medical professionals.</text> </paragraph> <paragraph num="E."> <text>An MCO shall utilize the trauma triage and transfer protocols established through the Maryland Institute for Emergency Medical Services Systems (MIEMSS) as the basis for directing the severely injured enrollee to the most appropriate level designated trauma center.</text> </paragraph> <paragraph num="F."> <text>An MCO shall reimburse, within 30 days of invoice, the undisputed claims of hospital emergency facilities and providers for the following services provided to the MCO's enrollees:</text> <paragraph num="(1)"> <text>Emergency services, as defined in COMAR 10.67.01.01B;</text> </paragraph> <paragraph num="(2)"> <text>Medical screening services based on the federal Emergency Medical Treatment and Active Labor Act (EMTALA);</text> </paragraph> <paragraph num="(3)"> <text>If the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility, medically necessary services that are related to the emergency condition, including poststabilization services; and</text> </paragraph> <paragraph num="(4)"> <text>If the MCO fails to provide 24 hour access to a physician, medically necessary services that relate to the condition presented and that are provided by the provider in an emergency facility to the enrollee.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Poststabilization Services. The MCO may not require preapproval of, and is financially responsible for, poststabilization services obtained in or outside of the MCO's network and administered to maintain, improve, or resolve the enrollee's stabilized condition if:</text> <paragraph num="(1)"> <text>The MCO does not respond to a request for a preapproval within 1 hour;</text> </paragraph> <paragraph num="(2)"> <text>The MCO cannot be contacted; or</text> </paragraph> <paragraph num="(3)"> <text>The MCO representative and the treating physician cannot reach an agreement concerning the enrollee's care, and an MCO physician is not available for consultation, in which case:</text> <paragraph num="(a)"> <text>The MCO shall give the treating physician the opportunity to consult with an MCO physician; and</text> </paragraph> <paragraph num="(b)"> <text>The treating physician may continue care of the patient until a plan is reached or one of the following criteria is met:</text> <paragraph num="(i)"> <text>An MCO physician with privileges at the treating hospital assumes responsibility for the enrollee's care;</text> </paragraph> <paragraph num="(ii)"> <text>An MCO physician assumes responsibility for the enrollee's care through transfer;</text> </paragraph> <paragraph num="(iii)"> <text>An MCO representative and the treating physician reach an agreement concerning the enrollee's care; or</text> </paragraph> <paragraph num="(iv)"> <text>The enrollee is discharged.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>An MCO may require that any continuing care be obtained from the MCO's providers or from providers approved by the MCO when the following conditions are satisfied:</text> <paragraph num="(1)"> <text>The enrollee's medical condition is appropriately stabilized and permits transferring responsibility for the enrollee's care, without medically harmful consequences, to these providers; and</text> </paragraph> <paragraph num="(2)"> <text>The transfer is consistent with the requirements of the federal Emergency Medical Treatment and Active Labor Act (EMTALA).</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Access: Hospitals."> <paragraph num="A."> <text>An MCO shall comply with the access standards specified in Regulation .06A of this chapter.</text> </paragraph> <paragraph num="B."> <text>If an MCO’s service area includes a county that is designated as a medically underserved area and there is only one hospital in the county, the MCO shall include the hospital in its network.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104, 15-102.1(b)(10), 15-102.3 and 15-103; Insurance Article §§15-112, 15-605, and 15-1008; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective February 18, 2002 (29:3 Md. R. 220); June 30, 2008 (35:13 Md. R. 1180); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulations .03 and .04 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective February 9, 1998 (25:3 Md. R. 144); February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 25, 2001 (28:12 Md. R. 1109)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141) August 29, 2016 (43:17 Md. R. 955); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 adopted effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1 amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective April 28, 2014 (41:8 Md. R. 471); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective February 2, 2004 (31:2 Md. R. 82); April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, D amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, D amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B, C amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, F amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 adopted effective March 14, 2016 (43:5 Md. R. 385)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.66 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1A amended effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05-1C amended effective October 18, 2021 (48:21 Md. R. 889); April 28, 2025 (52:8 Md. R. 359)</annotation> </annotations> </chapter> <chapter num="06" heading="Maryland Medicaid Managed Care Program: Benefits"> <regulation prefix="Regulation" num=".01" heading="Required Benefits Package — In General."> <paragraph num="A."> <text>Except for non-covered services set forth in Regulation .27 of this chapter and the non-capitated services described in COMAR 10.67.08, an MCO shall provide its enrollees with a benefits package that includes the covered services specified in this chapter when these services are deemed to be medically necessary including services covered under the Maryland Medicaid State Plan in the amount, duration, and scope set forth in the State Plan and in accordance with 42 CFR §440.230.</text> </paragraph> <paragraph num="B."> <text>An MCO shall ensure that the services provided are sufficient in amount, duration, or scope to reasonably achieve the purpose for which the services are furnished.</text> </paragraph> <paragraph num="C."> <text>An MCO is not required to provide non-covered services even when the service is medically necessary.</text> </paragraph> <paragraph num="D."> <text>Any limitations set forth in this chapter on covered services are not applicable to services required by enrollees who are younger than 21 years old when it is shown that the services are medically necessary to correct or lessen health problems detected or suspected by EPSDT screening services, as described in Regulation .20 of this chapter.</text> </paragraph> <paragraph num="E."> <text>An MCO may place appropriate limits on a service on the basis of criteria applied under the State plan, such as medical necessity.</text> </paragraph> <paragraph num="F."> <text>Cost Sharing and Prohibitions.</text> <paragraph num="(1)"> <text>Except for the following, an MCO may not charge its enrollees any copayments, premiums, or cost sharing:</text> <paragraph num="(a)"> <text>Up to a $3 copayment for brand-name drugs;</text> </paragraph> <paragraph num="(b)"> <text>Up to a $1 copayment for generic drugs;</text> </paragraph> <paragraph num="(c)"> <text>Any other charge up to fee-for-service limits as approved by the Department.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO may not:</text> <paragraph num="(a)"> <text>Deny services to an individual who is eligible for services because of the individual's inability to pay the cost sharing;</text> </paragraph> <paragraph num="(b)"> <text>Impose copayments for the following:</text> <paragraph num="(i)"> <text>Family planning services and supplies;</text> </paragraph> <paragraph num="(ii)"> <text>Individuals younger than 21 years old;</text> </paragraph> <paragraph num="(iii)"> <text>Pregnant women;</text> </paragraph> <paragraph num="(iv)"> <text>Institutionalized individuals who are inpatients in long-term care facilities or other institutions; and</text> </paragraph> <paragraph num="(v)"> <text>Emergency services.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the enrollee.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>An MCO shall ensure that all health care services provided under this chapter are performed, to the extent required by law, by an appropriate health care provider who is licensed, certified, or otherwise legally authorized to practice or deliver the services in the state in which the service is provided.</text> </paragraph> <paragraph num="H."> <text>An MCO shall provide for a second opinion from a qualified health care professional within the network, or, if necessary, arrange for the enrollee to obtain one outside the MCO network.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Benefits — Primary Care Services."> <text>An MCO shall provide to its enrollees medically necessary primary care services that are provided:</text> <paragraph num="A."> <text>By the enrollee's PCP;</text> </paragraph> <paragraph num="B."> <text>At the direction of the enrollee's PCP; or</text> </paragraph> <paragraph num="C."> <text>With respect to a primary care service that is self-referred pursuant to Regulation .28 of this chapter:</text> <paragraph num="(1)"> <text>By an appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience; or</text> </paragraph> <paragraph num="(2)"> <text>By a clinic that furnishes health care services by or under the direction of a physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Benefits — Physician and Advanced Practice Nurse Specialty Care Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary specialty care services that are outside of the enrollee's PCP's scope of practice, or, in the judgment of the enrollee's PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in and are provided by:</text> <paragraph num="(1)"> <text>A physician or an advanced practice nurse, acting within the scope of the individual's license or certification, training, and experience;</text> </paragraph> <paragraph num="(2)"> <text>A practitioner other than a physician or an advanced practice nurse when the practitioner is in a physician's employ, is under the physician's direct supervision, and performs the service within the scope of the practitioner's license, certification, or other legal authorization, for the purpose of assisting in the provision of the specialty care service;</text> </paragraph> <paragraph num="(3)"> <text>A clinic that furnishes health care services by or under the direction of a physician; or</text> </paragraph> <paragraph num="(4)"> <text>For enrollees who are younger than 21 years old, a doctor of dental medicine or dental surgery, if the services are surgical services that are also typically performed by physicians.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notwithstanding §A(2) of this regulation, specialty care services provided under Regulations .04—.25 of this chapter may include medically necessary diagnostic and treatment services provided by a physician or other appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Benefits — Pharmacy Services."> <paragraph num="A."> <text>An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act.</text> </paragraph> <paragraph num="B."> <text>An MCO shall provide to its enrollees all medically necessary pharmaceutical services and pharmaceutical counseling, including but not limited to:</text> <paragraph num="(1)"> <text>Legend drugs;</text> </paragraph> <paragraph num="(2)"> <text>Insulin;</text> </paragraph> <paragraph num="(3)"> <text>All FDA approved contraceptives;</text> </paragraph> <paragraph num="(4)"> <text>Hypodermic needles and syringes;</text> </paragraph> <paragraph num="(5)"> <text>Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home;</text> </paragraph> <paragraph num="(6)"> <text>Enteric coated aspirin prescribed for the treatment of arthritic conditions;</text> </paragraph> <paragraph num="(7)"> <text>Nonlegend ferrous sulfate oral preparations;</text> </paragraph> <paragraph num="(8)"> <text>Nonlegend chewable tablets of any ferrous salt when combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation when the enrollee is younger than 12 years old;</text> </paragraph> <paragraph num="(9)"> <text>Medical supplies used in the preparation of compounded prescriptions for home intravenous therapy;</text> </paragraph> <paragraph num="(10)"> <text>Medical supplies or equipment used in the administration or monitoring of medication prescribed or ordered for an enrollee by a qualifying provider as specified in §B of this regulation;</text> </paragraph> <paragraph num="(11)"> <text>Latex condoms;</text> </paragraph> <paragraph num="(12)"> <text>Nonlegend ergocalciferol liquid (Vitamin D); and</text> </paragraph> <paragraph num="(13)"> <text>Emergency contraceptives for female recipients.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by:</text> <paragraph num="(1)"> <text>An MCO provider;</text> </paragraph> <paragraph num="(2)"> <text>An out-of-plan provider, when the pharmacy services are ordered or prescribed in connection with medical care furnished by the provider to the MCO's enrollee:</text> <paragraph num="(a)"> <text>In response to the enrollee's emergency medical condition; or</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to the enrollee's self-referral to the provider, when the care delivered qualifies as a permissible self-referred service under Regulation .28 of this chapter; or</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A behavioral health provider for drugs not in the behavioral health formulary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO shall provide over-the-counter emergency contraceptives and latex condoms to enrollees without requiring an order from an authorized prescriber.</text> </paragraph> <paragraph num="E."> <text>An MCO shall provide coverage for the following when performed by a pharmacist:</text> <paragraph num="(1)"> <text>Contraceptive services, as follows:</text> <paragraph num="(a)"> <text>A patient assessment performed at the pharmacist’s practice location in order to determine:</text> <paragraph num="(i)"> <text>Whether to prescribe contraceptives; and</text> </paragraph> <paragraph num="(ii)"> <text>Which contraceptive options to prescribe; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If contraceptives are prescribed, a referral:</text> <paragraph num="(i)"> <text>To the participant’s primary care practitioner or reproductive health care practitioner; or</text> </paragraph> <paragraph num="(ii)"> <text>If the participant does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Administration of:</text> <paragraph num="(a)"> <text>Injectable medications for the treatment of sexually transmitted infection; and</text> </paragraph> <paragraph num="(b)"> <text>Maintenance injectables medications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Drug Formulary.</text> <paragraph num="(1)"> <text>An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program, and include at a minimum:</text> <paragraph num="(a)"> <text>Covered generic and name brand medications; and</text> </paragraph> <paragraph num="(b)"> <text>The tier each medication is on.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An MCO shall include in its formulary drugs that are appropriate for medical management, safe, and effective.</text> </paragraph> <paragraph num="(3)"> <text>An MCO shall expand its formulary, as needed, to include drugs that are equivalent to new drugs approved by the federal Food and Drug Administration, and which are deemed to be appropriate, safe, and efficacious in the medical management of the MCO's enrollees.</text> </paragraph> <paragraph num="(4)"> <text>An MCO shall include in its formulary the following drugs:</text> <paragraph num="(a)"> <text>Leuprolide acetate;</text> </paragraph> <paragraph num="(b)"> <text>Clonidine;</text> </paragraph> <paragraph num="(c)"> <text>Guanfacine;</text> </paragraph> <paragraph num="(d)"> <text>Medroxyprogesterone; and</text> </paragraph> <paragraph num="(e)"> <text>Liothyronine.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>To ensure that its formulary drugs are medically necessary, safe, and efficacious, an MCO shall:</text> <paragraph num="(a)"> <text>Subject its formulary to a review process that is:</text> <paragraph num="(i)"> <text>Established and conducted by the MCOs Pharmacy and Therapeutics Committee;</text> </paragraph> <paragraph num="(ii)"> <text>Approved by the Department; and</text> </paragraph> <paragraph num="(iii)"> <text>Coordinated with the formulary review process of the Specialty Mental Health Services delivery system; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Submit its formulary for the review and approval of the Department, based upon the standards set forth in this regulation.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Unless approved by the Department, an MCO may not require or utilize prior authorization or step therapy criteria for coverage of formulary drugs if such prior authorization or step therapy requires a recipient to use a drug that is included in the behavioral health formulary.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in §H of this regulation.</text> </paragraph> <paragraph num="H."> <text>In this regulation, the term specialty drug means:</text> <paragraph num="(1)"> <text>A prescription drug that:</text> <paragraph num="(a)"> <text>Is prescribed for an individual with a complex, chronic or rare medical condition;</text> </paragraph> <paragraph num="(b)"> <text>Costs $600 or more for up to a 30-day supply;</text> </paragraph> <paragraph num="(c)"> <text>Is not typically stocked at retail pharmacies; and</text> </paragraph> <paragraph num="(d)"> <text>Requires a difficult or unusual process of delivery to the patient in the preparation, handling storage, inventory or distribution of the drug; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug.</text> </paragraph> </paragraph> <paragraph num="I."> <text>. If an enrollee subsequently requests to use a retail pharmacy for specialty drugs the MCO may not limit the enrollee to the use of a mail order pharmacy.</text> </paragraph> <paragraph num="J."> <text>An MCO shall:</text> <paragraph num="(1)"> <text>Establish and maintain a drug utilization review program;</text> </paragraph> <paragraph num="(2)"> <text>Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components:</text> <paragraph num="(a)"> <text>Formulary management;</text> </paragraph> <paragraph num="(b)"> <text>Generic substitution;</text> </paragraph> <paragraph num="(c)"> <text>Therapeutic substitution;</text> </paragraph> <paragraph num="(d)"> <text>Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act;</text> </paragraph> <paragraph num="(e)"> <text>Drug use evaluation (DUE);</text> </paragraph> <paragraph num="(f)"> <text>Disease management; and</text> </paragraph> <paragraph num="(g)"> <text>Pharmacy and Therapeutic Committee;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and</text> </paragraph> <paragraph num="(4)"> <text>Provide to the Department a detailed description of its drug utilization review program activities on an annual basis.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The Department shall:</text> <paragraph num="(1)"> <text>Review each MCO’s drug utilization review program annually; and</text> </paragraph> <paragraph num="(2)"> <text>Notify an MCO annually if any of the standards established in §J(2) of this regulation have not been met.</text> </paragraph> </paragraph> <paragraph num="L."> <text>For any performance standard identified in §K(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.67.10.01A and B.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Benefits — Home Health Services."> <paragraph num="A."> <text>Subject to the conditions specified in §B of this regulation, an MCO shall provide to its enrollees medically necessary home health services, including:</text> <paragraph num="(1)"> <text>Skilled nursing services, including the supervisory visits required by §A(2) of this regulation;</text> </paragraph> <paragraph num="(2)"> <text>Home health aide services, including biweekly supervisory visits by a registered nurse in the recipient's home, every second visit of which includes observations of the delivery of services by the aide to the enrollee;</text> </paragraph> <paragraph num="(3)"> <text>Physical therapy services;</text> </paragraph> <paragraph num="(4)"> <text>Occupational therapy services;</text> </paragraph> <paragraph num="(5)"> <text>Speech pathology services; and</text> </paragraph> <paragraph num="(6)"> <text>Medical supplies that are used during a home health visit.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall provide the home health services specified in §A of this regulation that are:</text> <paragraph num="(1)"> <text>Certified by the enrollee's PCP or by the enrollee's attending physician to be required on a part-time, intermittent basis; and</text> </paragraph> <paragraph num="(2)"> <text>Rendered in the enrollee's home.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Benefits — Habilitation Services for Medicaid Expansion Populations"> <paragraph num="A."> <text>An MCO shall provide the following medically necessary habilitation services to enrollees eligible for Medical Assistance under §1902(a)(10)(A)(i)(VIII) of the Social Security Act:</text> <paragraph num="(1)"> <text>Physical therapy;</text> </paragraph> <paragraph num="(2)"> <text>Occupation therapy; and</text> </paragraph> <paragraph num="(3)"> <text>Speech therapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At a minimum, an MCO shall provide the services in hospital inpatient and outpatient departments and physical therapy in an outpatient community setting.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Benefits — Inpatient Hospital Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary inpatient hospital services as specified in this regulation.</text> </paragraph> <paragraph num="B."> <text>Admission to Long-Term Care Facility.</text> <paragraph num="(1)"> <text>An MCO shall provide to its enrollees medically necessary long-term care facility services for:</text> <paragraph num="(a)"> <text>The first 90 continuous days following the enrollee's admission; and</text> </paragraph> <paragraph num="(b)"> <text>Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department's determination that the admission is medically necessary as specified in §B(2) of this regulation.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary.</text> </paragraph> <paragraph num="(3)"> <text>The Department’s determination as described in §B(2) of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day.</text> </paragraph> <paragraph num="(4)"> <text>Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall render a determination with respect to the medical necessity of a stay in a long-term care facility as specified in §B of this regulation within 3 business days of receipt of a complete application from the MCO.</text> </paragraph> <paragraph num="D."> <text>Childbirth — Length of Stay and Home Visits.</text> <paragraph num="(1)"> <text>Except as provided in §D(2) and (3) of this regulation, the criteria and standards used by an MCO in performing utilization review of hospital services related to maternity and newborn care, including length of stay, shall be in accordance with the medical criteria outlined in the Guidelines for Perinatal Care, which is incorporated by reference in COMAR 10.67.04.01.</text> </paragraph> <paragraph num="(2)"> <text>Unless the enrollee decides, in consultation with her attending provider, that less time is needed for recovery, an MCO shall provide or reimburse the cost of hospitalization including at least the following length of stay for an enrollee recovering from childbirth:</text> <paragraph num="(a)"> <text>48 hours of inpatient hospitalization care following an uncomplicated vaginal delivery; or</text> </paragraph> <paragraph num="(b)"> <text>96 hours of inpatient hospitalization care following an uncomplicated cesarean section.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the enrollee elects to be discharged earlier than the length of stay specified in §D(2) of this regulation, the MCO is required to provide a home visit or visits pursuant to Regulation .21B—D of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the mother's length of stay required to be afforded by §D(2) of this regulation, whenever a mother is required to remain hospitalized after childbirth for medical reasons and she requests that her newborn remain in the hospital while she is hospitalized, the MCO shall afford the newborn additional hospitalization while the mother remains hospitalized, for up to 4 days.</text> </paragraph> <paragraph num="F."> <text>If an enrollee is in the hospital at the time of disenrollment from the MCO, and remains eligible for Medical Assistance, the MCO is responsible for covering the remainder of that hospital admission following disenrollment.</text> </paragraph> <paragraph num="G."> <text>An MCO shall provide for a private hospital room when:</text> <paragraph num="(1)"> <text>The enrollee's condition requires a need for isolation; or</text> </paragraph> <paragraph num="(2)"> <text>The enrollee requires admission and only private rooms are available.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Payment For Ancillary Services.</text> <paragraph num="(1)"> <text>Effective January 1, 2009, an MCO shall pay for all medically necessary ancillary services provided on inpatient hospital days including those days for which the inpatient hospitalization is otherwise appropriately denied.</text> </paragraph> <paragraph num="(2)"> <text>A denial of an inpatient ancillary service shall be based on the medical necessity of the specific ancillary service.</text> </paragraph> <paragraph num="(3)"> <text>An MCO is not required to pay for ancillary services if the entire hospitalization in §H(1) of this regulation is appropriately denied.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Transports between hospitals are covered by the MCO when:</text> <paragraph num="(1)"> <text>A medically necessary covered service is not available at the hospital where an enrollee is being treated; and</text> </paragraph> <paragraph num="(2)"> <text>The enrollee is not being discharged from the sending hospital.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Benefits — Outpatient Hospital Services."> <text>An MCO's benefits package shall include medically necessary outpatient hospital services.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Benefits — Transplants."> <text>An MCO shall provide to its enrollees medically necessary transplants.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Benefits — Substance Abuse Treatment Service — Repealed" /> <regulation prefix="Regulation" num=".11" heading="Benefits — Diagnostic and Laboratory Services."> <text>An MCO shall provide to its enrollees medically necessary:</text> <paragraph num="A."> <text>Diagnostic services; and</text> </paragraph> <paragraph num="B."> <text>Laboratory services, performed by a provider who:</text> <paragraph num="(1)"> <text>Is Clinical Laboratory Improvement Amendments (CLIA) certified; or</text> </paragraph> <paragraph num="(2)"> <text>Has a waiver of a certificate registration along with a CLIA identification number.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Benefits — Long-Term Care Facility Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary services in a chronic hospital, a chronic rehabilitation hospital, or a nursing facility for:</text> <paragraph num="(1)"> <text>The first 90 continuous days following the enrollee's admission; and</text> </paragraph> <paragraph num="(2)"> <text>Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department’s determination that the admission is medically necessary as specified in §C of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility.</text> </paragraph> <paragraph num="C."> <text>For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary.</text> </paragraph> <paragraph num="D."> <text>The Department’s determination as described in §C of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day.</text> </paragraph> <paragraph num="E."> <text>The Department shall render a determination with respect to the medical necessity of a stay in a nursing facility as specified in §C of this regulation within 3 business days of receipt of a complete application from the MCO.</text> </paragraph> <paragraph num="F."> <text>A determination by the Department that the admission is medically necessary does not relieve the MCO of the obligation to pay for the admission through the day on which the determination is made.</text> </paragraph> <paragraph num="G."> <text>An MCO shall use the Department’s criteria for determining medical necessity for the days described in §A(1) of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Benefits — Disposable Medical Supplies and Durable Medical Equipment."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary disposable medical supplies and durable medical equipment, including but not limited to:</text> <paragraph num="(1)"> <text>All supplies and equipment used in the administration or monitoring of prescriptions by the enrollees;</text> </paragraph> <paragraph num="(2)"> <text>Incontinency pants and disposable underpads for medical conditions associated with prolonged urinary or bowel incontinence if necessary to prevent institutionalization or infection;</text> </paragraph> <paragraph num="(3)"> <text>Orthotic devices when medically necessary for use in the MCO enrollee’s home, school, or place of employment;</text> </paragraph> <paragraph num="(4)"> <text>Prosthetic devices once annually when medically necessary:</text> <paragraph num="(a)"> <text>For use in the enrollee’s home, school, or place of employment; or</text> </paragraph> <paragraph num="(b)"> <text>For the purpose of performing physical activities, including running, biking, swimming, strength training, and other activities to maximize the whole-body health and lower or upper limb function of the enrollee;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Annual repairs to prosthetic devices covered under §A(4) of this regulation when:</text> <paragraph num="(a)"> <text>Medically necessary; and</text> </paragraph> <paragraph num="(b)"> <text>When the repair’s necessity is not due to misuse;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Replacement of prosthetic devices covered under §A(4)of this regulation when medically necessary as follows:</text> <paragraph num="(a)"> <text>Once annually for devices less than 3 years old if the replacement is necessary for the following reasons:</text> <paragraph num="(i)"> <text>Because of a change in the physiological condition of the patient;</text> </paragraph> <paragraph num="(ii)"> <text>Unless necessitated by misuse, because of an irreparable change in the condition of the prosthesis or the component of the prosthetic device; or</text> </paragraph> <paragraph num="(iii)"> <text>Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For devices more than 3 years old subject to §A(4) and (5) of this regulation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Except as required in §C(1), an MCO shall provide preauthorization within 72 hours for DMS/DME services and supplies that require preauthorization by the MCO.</text> </paragraph> <paragraph num="C."> <text>An MCO shall provide its enrollees the disposable medical supplies and durable medical equipment in a timely manner so as to not adversely affect the health of the enrollees, in accordance with the following:</text> <paragraph num="(1)"> <text>For medical equipment or supplies, or both, when there is an urgent medical need such as to facilitate hospital discharge or when a potential exists for worsening of enrollee's condition, the MCO shall provide needed items within 24 hours of request; and</text> </paragraph> <paragraph num="(2)"> <text>For all other requests for DMS/DME, the MCO shall provide these items within 7 days from the date of request unless the MCO can document to the Department that justification for additional time is necessary.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO is responsible for paying for any durable medical equipment authorized and ordered while the member is active with the MCO if:</text> <paragraph num="(1)"> <text>The delivery of the item occurs within 90 days after the member's termination date from the MCO; and</text> </paragraph> <paragraph num="(2)"> <text>The member remains a Medicaid recipient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Benefits — Vision Care Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary vision care services as specified in this regulation.</text> </paragraph> <paragraph num="B."> <text>For enrollees who are 21 years old or older, the MCO is responsible for providing at least one eye examination every 2 years.</text> </paragraph> <paragraph num="C."> <text>For its enrollees who are younger than 21 years old, the MCO is responsible for providing medically necessary vision services, including but not limited to:</text> <paragraph num="(1)"> <text>At least one eye examination every year in addition to any vision screen performed as part of an EPSDT screen;</text> </paragraph> <paragraph num="(2)"> <text>Eyeglasses, limited to one pair per year unless lost, stolen, broken, or no longer vision appropriate; and</text> </paragraph> <paragraph num="(3)"> <text>Contact lenses, if medically necessary and if eyeglasses are not efficacious for the condition.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Benefits — Podiatry Services."> <paragraph num="A."> <text>An MCO shall provide for its enrollees medically necessary podiatry services.</text> </paragraph> <paragraph num="B."> <text>In addition to the services described in §A of this regulation, an MCO shall provide:</text> <paragraph num="(1)"> <text>Diabetes care services specified in COMAR 10.67.06.24; and</text> </paragraph> <paragraph num="(2)"> <text>Routine foot care for enrollees, 21 years old or older with vascular disease affecting the lower extremities.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Benefits — Outpatient Rehabilitative Services."> <text>An MCO shall provide to its enrollees medically necessary outpatient rehabilitative services, including but not limited to physical therapy for adult enrollees.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Benefits — Oxygen and Related Respiratory Equipment."> <text>An MCO shall provide to its enrollees medically necessary oxygen and related respiratory equipment services.</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Benefits — Dialysis Services."> <text>An MCO shall provide to its enrollees medically necessary dialysis services.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Benefits — Family Planning Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees comprehensive family planning services, including but not limited to medically necessary office visits and laboratory tests, all FDA-approved contraceptive devices, methods, and supplies, and voluntary sterilizations.</text> </paragraph> <paragraph num="B."> <text>An MCO may place appropriate limits on family planning services for the purpose of utilization control, provided that the services are provided in a manner that protects and enables the enrollee’s freedom to choose the method of family planning to be used consistent with 42 CFR §441.20.</text> </paragraph> <paragraph num="C."> <text>An MCO may not apply a copayment or coinsurance requirement for contraceptive drugs or devices.</text> </paragraph> <paragraph num="D."> <text>An MCO shall provide coverage for a single dispensing of a supply of prescription contraceptives for a 12-month period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Benefits — EPSDT Services."> <paragraph num="A."> <text>An MCO shall provide, to enrollees younger than 21 years old, medically necessary Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) services, including:</text> <paragraph num="(1)"> <text>EPSDT comprehensive well-child services provided in accordance with the EPSDT periodicity schedule and performed by an EPSDT-certified provider, including:</text> <paragraph num="(a)"> <text>A comprehensive health and developmental history, including an evaluation of both physical and mental health development;</text> </paragraph> <paragraph num="(b)"> <text>A comprehensive unclothed physical exam;</text> </paragraph> <paragraph num="(c)"> <text>Immunizations appropriate to age and health history;</text> </paragraph> <paragraph num="(d)"> <text>Laboratory tests, including blood lead level assessment, as appropriate to age and risk;</text> </paragraph> <paragraph num="(e)"> <text>Health education, including anticipatory guidance; and</text> </paragraph> <paragraph num="(f)"> <text>Vision, hearing, and dental screening;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>EPSDT partial or interperiodic well-child services; and</text> </paragraph> <paragraph num="(3)"> <text>Health care services that are:</text> <paragraph num="(a)"> <text>Necessary to prevent, treat, or ameliorate physical, mental, or developmental problems or conditions identified by an EPSDT-certified provider or other health professional;</text> </paragraph> <paragraph num="(b)"> <text>Sufficient in amount, duration, and scope to treat the identified condition; and</text> </paragraph> <paragraph num="(c)"> <text>Subject to limitation only on the basis of medical necessity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The health care services described in §A(3) of this regulation shall include, at a minimum, all services described in this chapter, and the following:</text> <paragraph num="(1)"> <text>Chiropractic services;</text> </paragraph> <paragraph num="(2)"> <text>Nutrition counseling services;</text> </paragraph> <paragraph num="(3)"> <text>Private duty nursing services including:</text> <paragraph num="(a)"> <text>An initial assessment and development of a plan of care by a registered nurse; and</text> </paragraph> <paragraph num="(b)"> <text>On-going private duty nursing services delivered by a licensed practical nurse or a registered nurse; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Durable medical equipment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall provide referrals for services not covered by Medicaid, but which are furnished at little or no cost to recipients, including appropriate referrals to:</text> <paragraph num="(1)"> <text>The Head Start Program;</text> </paragraph> <paragraph num="(2)"> <text>The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC);</text> </paragraph> <paragraph num="(3)"> <text>School Health-Related Special Education Services;</text> </paragraph> <paragraph num="(4)"> <text>Vocational Rehabilitation; and</text> </paragraph> <paragraph num="(5)"> <text>Maternal and Child Health Services located at local health departments.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Benefits — Pregnancy-Related Services."> <paragraph num="A."> <text>An MCO shall provide to its pregnant and postpartum enrollees medically necessary pregnancy-related services, including:</text> <paragraph num="(1)"> <text>Comprehensive prenatal, perinatal, and postpartum care, including high-risk specialty care when appropriate;</text> </paragraph> <paragraph num="(2)"> <text>Prenatal risk assessment and development of an individualized plan of care that specifies the actions required to address each identified need and is appropriately modified during the course of care;</text> </paragraph> <paragraph num="(3)"> <text>Enriched maternity services, including:</text> <paragraph num="(a)"> <text>Prenatal and postpartum counseling and education;</text> </paragraph> <paragraph num="(b)"> <text>Basic nutritional education;</text> </paragraph> <paragraph num="(c)"> <text>Substance abuse treatment, as provided in Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(d)"> <text>Appropriate referrals to services that may improve the pregnancy outcome, including:</text> <paragraph num="(i)"> <text>Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and</text> </paragraph> <paragraph num="(ii)"> <text>Healthy Start services;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>High-risk nutrition counseling services for nutritionally high-risk pregnant women;</text> </paragraph> <paragraph num="(f)"> <text>Appropriate levels of inpatient care, including emergency transfer of pregnant women and newborns to tertiary care centers;</text> </paragraph> <paragraph num="(g)"> <text>Smoking cessation education and treatment;</text> </paragraph> <paragraph num="(h)"> <text>Doula services; and</text> </paragraph> <paragraph num="(i)"> <text>Home visiting services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When an enrollee recovering from childbirth elects to be discharged before 48 hours following a normal vaginal delivery or 96 hours following an uncomplicated cesarean section, the MCO is responsible for providing:</text> <paragraph num="(1)"> <text>One home visit scheduled to occur within 24 hours after discharge; and</text> </paragraph> <paragraph num="(2)"> <text>An additional home visit as may be prescribed by the attending provider.</text> </paragraph> </paragraph> <paragraph num="C."> <text>When an enrollee recovering from childbirth and her newborn enrollee remain in the hospital for at least as long as the period of time provided under §B of this regulation, the MCO shall provide a home visit as prescribed by the attending provider.</text> </paragraph> <paragraph num="D."> <text>An MCO shall provide for home visits required by §§B and C of this regulation to be performed by a registered nurse and in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child, including:</text> <paragraph num="(1)"> <text>An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant;</text> </paragraph> <paragraph num="(2)"> <text>An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse symptoms of the mother;</text> </paragraph> <paragraph num="(3)"> <text>Collection of a blood specimen for newborn screening if not previously completed;</text> </paragraph> <paragraph num="(4)"> <text>Referrals for any medically necessary continuing health care services; and</text> </paragraph> <paragraph num="(5)"> <text>Any other nursing services ordered by the referring provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Benefits — Case Management Services for HIV-Infected Individuals."> <text>An MCO shall provide medically necessary case management services to its qualifying enrollees, as specified in COMAR 10.67.04.10C.</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Benefits — Hospice Care Services."> <paragraph num="A."> <text>An MCO shall include in its benefits package medically necessary hospice care services to enrollees who are terminally ill.</text> </paragraph> <paragraph num="B."> <text>The Department shall allow an enrollee to disenroll from an MCO and choose a new MCO if:</text> <paragraph num="(1)"> <text>The enrollee was auto-assigned to the MCO; and</text> </paragraph> <paragraph num="(2)"> <text>The enrollee's hospice provider does not contract with the enrollee's assigned MCO.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an enrollee who is in a hospice that does not contract with the enrollee's MCO and the enrollee will not voluntarily choose a new MCO, the enrollee's current MCO:</text> <paragraph num="(1)"> <text>Shall authorize and pay the out-of-network hospice provider at the established Medicaid rate, to ensure continuity of care; and</text> </paragraph> <paragraph num="(2)"> <text>May not require the hospice care enrollee to change their out-of-network hospice provider to an in-network hospice provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Benefits — Diabetes Prevention and Care Services."> <paragraph num="A."> <text>An MCO shall provide to its qualifying enrollees medically necessary diabetes prevention and care services as specified in this regulation.</text> </paragraph> <paragraph num="B."> <text>National Diabetes Prevention Program.</text> <paragraph num="(1)"> <text>In addition to the services included in its usual benefits package, an MCO shall make available to its enrollees who meet the Centers for Disease Control and Prevention (CDC) eligibility criteria defined in §B(2) of this regulation the National Diabetes Prevention Program through a CDC-recognized lifestyle change organization.</text> </paragraph> <paragraph num="(2)"> <text>To be eligible for participation in the National Diabetes Prevention Program, a HealthChoice enrollee:</text> <paragraph num="(a)"> <text>Shall be 18 through 64 years old;</text> </paragraph> <paragraph num="(b)"> <text>Shall be overweight or obese;</text> </paragraph> <paragraph num="(c)"> <text>Shall have an elevated blood glucose level or a history of gestational diabetes mellitus;</text> </paragraph> <paragraph num="(d)"> <text>May not have a previous diagnosis of type 1 or type 2 diabetes prior to enrollment; and</text> </paragraph> <paragraph num="(e)"> <text>May not be currently pregnant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the services included in its usual benefits package, an MCO shall provide enrollees with a diabetes diagnosis the following medically necessary special diabetes-related services:</text> <paragraph num="(1)"> <text>Diabetes nutrition counseling, consisting of one initial one-on-one session and up to 4 subsequent sessions annually;</text> </paragraph> <paragraph num="(2)"> <text>Diabetes outpatient education;</text> </paragraph> <paragraph num="(3)"> <text>Diabetes-related durable medical equipment, disposable medical supplies, and therapeutic footwear and related services, when ordered as medically necessary, including:</text> <paragraph num="(a)"> <text>Therapeutic footwear, orthopedic shoes, arch supports, orthotic devices, in-shoe supports, elastic support, or examinations for prescription or fitting and related services to prevent or delay a foot amputation that would be highly probable in the absence of the specialized footwear;</text> </paragraph> <paragraph num="(b)"> <text>Blood glucose monitoring supplies;</text> </paragraph> <paragraph num="(c)"> <text>Diagnostic reagent strips and tablets used in testing for ketones and glucose in urine and glucose in blood;</text> </paragraph> <paragraph num="(d)"> <text>Finger-sticking devices used in obtaining blood samples for blood glucose testing; and</text> </paragraph> <paragraph num="(e)"> <text>Blood glucose reflectance meters for home use;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Routine foot care; and</text> </paragraph> <paragraph num="(5)"> <text>Vision care consisting of:</text> <paragraph num="(a)"> <text>One ophthalmologic examination per year; and</text> </paragraph> <paragraph num="(b)"> <text>One pair of eyeglasses per year.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".25" heading="Benefits — Blood and Blood Products."> <text>An MCO shall provide to its enrollees medically necessary blood, blood products, derivatives, components, biologics, and serums to include autologous services, whole blood, red blood cells, platelets, plasma, immunoglobulin, and albumin.</text> </regulation> <regulation prefix="Regulation" num=".26" heading="Benefits — Primary Mental Health Services."> <paragraph num="A."> <text>An MCO shall provide to its enrollees medically necessary primary mental health services, including appropriate referrals for service to the Department’s behavioral health ASO as described in COMAR 10.09.59.</text> </paragraph> <paragraph num="B."> <text>Effective October 1, 2023, MCOs shall provide their enrollees medically necessary primary mental health services, including the Collaborative Care Model, pursuant to COMAR 10.09.64.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-1" heading="Clinical Trial Items and Services — Coverage for Routine Costs."> <paragraph num="A."> <text>Subject to the conditions specified in §§B—F of this regulation, an MCO shall provide coverage for cost to an enrollee in an approved clinical trial for:</text> <paragraph num="(1)"> <text>Treatment provided for life-threatening conditions; or</text> </paragraph> <paragraph num="(2)"> <text>Prevention, early detection, and treatment studies on cancer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Clinical trials are deemed to be automatically approved if:</text> <paragraph num="(1)"> <text>The treatment is:</text> <paragraph num="(a)"> <text>Being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trials for cancer; or</text> </paragraph> <paragraph num="(b)"> <text>Being provided in Phase I, Phase II, Phase III, or Phase IV clinical trial for any other life-threatening condition;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The treatment is being provided in a clinical trial:</text> <paragraph num="(a)"> <text>Approved by:</text> <paragraph num="(i)"> <text>The National Institutes of Health (NIH);</text> </paragraph> <paragraph num="(ii)"> <text>An NIH cooperative group or an NIH center;</text> </paragraph> <paragraph num="(iii)"> <text>The Centers for Disease Control and Prevention;</text> </paragraph> <paragraph num="(iv)"> <text>The Agency for Healthcare Research and Quality;</text> </paragraph> <paragraph num="(v)"> <text>The Centers for Medicare and Medicaid Services (CMS);</text> </paragraph> <paragraph num="(vi)"> <text>The Department of Defense;</text> </paragraph> <paragraph num="(vii)"> <text>The Department of Veterans Affairs; or</text> </paragraph> <paragraph num="(viii)"> <text>An institutional review board of an institution in the State that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NIH; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Conducted:</text> <paragraph num="(i)"> <text>At National Cancer Institute Centers;</text> </paragraph> <paragraph num="(ii)"> <text>Under Investigational New Drug application (IND) reviewed by the Food and Drug Administration (FDA); or</text> </paragraph> <paragraph num="(iii)"> <text>As a clinical trial with deemed status through an exemption from having an IND under 21 CFR §312.2(b)(1);</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The facility and the personnel providing the treatment are capable of doing so by virtue of the facility and the personnel's experience, training, and volume of patients treated to maintain expertise;</text> </paragraph> <paragraph num="(4)"> <text>There is no clearly superior, non-investigational treatment alternative; and</text> </paragraph> <paragraph num="(5)"> <text>The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Enrollee cost includes the following:</text> <paragraph num="(1)"> <text>The cost of all medically necessary items and services that are otherwise available to Medicaid beneficiaries such as hospital services, physician services, or diagnostic tests; and</text> </paragraph> <paragraph num="(2)"> <text>The cost of medically necessary items or services required solely for the provision of the following:</text> <paragraph num="(a)"> <text>Investigational item or service such as administration of a noncovered chemotherapeutic agent;</text> </paragraph> <paragraph num="(b)"> <text>The clinically appropriate monitoring of the effects of the item or service; or</text> </paragraph> <paragraph num="(c)"> <text>The prevention, diagnosis, and treatment of complications.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Enrollee cost does not include the following:</text> <paragraph num="(1)"> <text>The cost of the investigational item or service itself;</text> </paragraph> <paragraph num="(2)"> <text>The cost of items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the enrollee;</text> </paragraph> <paragraph num="(3)"> <text>The cost of items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; and</text> </paragraph> <paragraph num="(4)"> <text>The cost of non-health care services that an enrollee may be required to receive as a result of the treatment being provided for purposes of the clinical trial.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If the enrollee has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the enrollee for, services covered by this regulation, the provider shall seek payment from that source first.</text> </paragraph> <paragraph num="F."> <text>The MCO shall authorize the request for participation in an approved clinical trial within 72 hours of the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-2" heading="Plastic and Restorative Surgery."> <text>An MCO shall provide to an enrollee medically necessary surgery to correct a deformity from disease, trauma, congenital or developmental anomalies, or to restore body functions.</text> </regulation> <regulation prefix="Regulation" num=".26-3" heading="Gender- Affirming Treatment."> <paragraph num="A."> <text>An MCO shall provide medically necessary gender-affirming treatment services which include but are not limited to the following:</text> <paragraph num="(1)"> <text>Hormone therapy, hormone blockers, and puberty blockers;</text> </paragraph> <paragraph num="(2)"> <text>Hair alteration for the purposes of altering secondary sex characteristics and surgical site preparation;</text> </paragraph> <paragraph num="(3)"> <text>Alterations to voice, voice therapy, and voice lessons;</text> </paragraph> <paragraph num="(4)"> <text>Alterations to abdomen, chest, trunk, and buttocks;</text> </paragraph> <paragraph num="(5)"> <text>Alterations to the face and neck;</text> </paragraph> <paragraph num="(6)"> <text>Alterations to the genitals and gonads;</text> </paragraph> <paragraph num="(7)"> <text>Laser treatment for scars from gender-affirming treatment;</text> </paragraph> <paragraph num="(8)"> <text>Standard fertility preservation procedures as set forth in Insurance Article, §15-810.1, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(9)"> <text>Revisions to previous treatments and reversal of treatments;</text> </paragraph> <paragraph num="(10)"> <text>Combinations of gender-affirming procedures; and</text> </paragraph> <paragraph num="(11)"> <text>Other treatments as prescribed to suppress the development of endogenous secondary sex characteristics, align the individual’s appearance of physical body with gender identity, and alleviate symptoms of clinically significant distress resulting from gender dysphoria.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO may not issue an adverse benefit determination denying or limiting access to gender-affirming treatment unless a health care provider with experience prescribing or delivering gender-affirming treatment has reviewed and confirmed the appropriateness of the adverse benefit determination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-4" heading="Audiology."> <text>An MCO shall provide enrollees medically necessary audiology services as described in COMAR 10.09.51, including:</text> <paragraph num="A."> <text>Hearing aids;</text> </paragraph> <paragraph num="B."> <text>Cochlear implants;</text> </paragraph> <paragraph num="C."> <text>Auditory osseointegrated devices; and</text> </paragraph> <paragraph num="D."> <text>Related services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".26-5" heading="Remote Patient Monitoring."> <text>An MCO shall provide its enrollees medically necessary remote patient monitoring services as described in COMAR 10.09.96.</text> </regulation> <regulation prefix="Regulation" num=".26-6" heading="Mobile Integrated Health Services."> <text>An MCO shall provide its enrollees medically necessary mobile integrated health services as described in COMAR 10.09.31.</text> </regulation> <regulation prefix="Regulation" num=".26-7" heading="Social Determinants of Health."> <text>Subject to COMAR 10.09.63, an MCO shall provide coverage for community violence prevention.</text> </regulation> <regulation prefix="Regulation" num=".27" heading="Benefits — Limitations."> <paragraph num="A."> <text>The benefits or services not required to be provided by an MCO are as follows:</text> <paragraph num="(1)"> <text>Experimental or investigational services, including organ transplants determined by Medicare to be experimental, except when an enrollee is participating in an authorized clinical trial as specified in Regulation .26-1 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Any service or treatment that is not medically necessary;</text> </paragraph> <paragraph num="(3)"> <text>Services performed or prescribed under the direction of a person who is not a health care practitioner;</text> </paragraph> <paragraph num="(4)"> <text>Services that are beyond the scope of practice of the health care practitioner performing the service;</text> </paragraph> <paragraph num="(5)"> <text>Transportation services provided through grants to local governments pursuant to COMAR 10.09.19, other than assisting enrollees to access nonemergency transportation services through their local transportation grantee agency;</text> </paragraph> <paragraph num="(6)"> <text>Health-related services and targeted case management services provided to children when the services are:</text> <paragraph num="(a)"> <text>Specified in the enrollee's individualized family service plan (IFSP), or an individualized education program (IEP); and</text> </paragraph> <paragraph num="(b)"> <text>Delivered in the schools or through Children's Medical Services community-based providers;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Autopsies;</text> </paragraph> <paragraph num="(8)"> <text>Immunizations required for travel outside the continental United States;</text> </paragraph> <paragraph num="(9)"> <text>Services received while the enrollee is outside the United States;</text> </paragraph> <paragraph num="(10)"> <text>Abortions;</text> </paragraph> <paragraph num="(11)"> <text>Diet and exercise programs for the loss of weight;</text> </paragraph> <paragraph num="(12)"> <text>Prescriptions or injections for central nervous system stimulants and anorectic agents when used for controlling weight;</text> </paragraph> <paragraph num="(13)"> <text>In vitro fertilization, ovum transplants and gamete intrafallopian tube transfer, zygote intrafallopian transfer, or other techniques used in these or similar procedures;</text> </paragraph> <paragraph num="(14)"> <text>Services to reverse a voluntary sterilization procedure;</text> </paragraph> <paragraph num="(15)"> <text>Lifestyle improvements, including smoking cessation, nutrition counseling, or physical fitness programs, unless specifically included as a covered service;</text> </paragraph> <paragraph num="(16)"> <text>Nonmedical ancillary services such as vocational rehabilitation, employment counseling, or educational therapy;</text> </paragraph> <paragraph num="(17)"> <text>Private duty nursing for adults 21 years old and older;</text> </paragraph> <paragraph num="(18)"> <text>Services incurred before the effective date of coverage for an enrollee;</text> </paragraph> <paragraph num="(19)"> <text>Dental or orthodontic care;</text> </paragraph> <paragraph num="(20)"> <text>Piped-in oxygen or oxygen prescribed for standby purposes or on an as-needed basis; and</text> </paragraph> <paragraph num="(21)"> <text>Cosmetic surgery when performed solely to maintain normal physical appearance or enhance beyond average level toward an aesthetic ideal.</text> </paragraph> <paragraph num="(22)"> <text>Enteral nutritional and supplemental vitamins and mineral products when administered orally.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO is not required to provide any of the benefits or services which are reimbursed directly by the Department as described in COMAR 10.67.08.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".28" heading="Benefits — Self-Referral Services."> <paragraph num="A."> <text>An MCO shall be financially responsible for reimbursing, in accordance with COMAR 10.67.04.20, an out-of-plan provider chosen by the participant for the following services:</text> <paragraph num="(1)"> <text>Family planning services specified in COMAR 10.67.04.20A(2), (6), and (7);</text> </paragraph> <paragraph num="(2)"> <text>Services performed by school-based health centers (SBHCs), as provided in COMAR 10.09.76;</text> </paragraph> <paragraph num="(3)"> <text>Pregnancy-related services for women who are pregnant and, at the time of initial enrollment, have received prenatal care during their current pregnancy from an out-of-plan provider, and this pre-enrollment care consists of at least the following:</text> <paragraph num="(a)"> <text>A full prenatal examination;</text> </paragraph> <paragraph num="(b)"> <text>A risk assessment; and</text> </paragraph> <paragraph num="(c)"> <text>Appropriate laboratory services;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Initial medical examination for children in State custody when performed by an EPSDT certified provider;</text> </paragraph> <paragraph num="(5)"> <text>One annual diagnostic and evaluation service (DES) visit for any enrollee diagnosed with HIV/AIDS, which the MCO is responsible for facilitating on the enrollee's behalf;</text> </paragraph> <paragraph num="(6)"> <text>Renal dialysis services performed in a Medicare-certified facility;</text> </paragraph> <paragraph num="(7)"> <text>Initial medical examination of a newborn when the:</text> <paragraph num="(a)"> <text>Examination is performed in a hospital by an on-call physician; and</text> </paragraph> <paragraph num="(b)"> <text>MCO failed to provide for the service before the newborn's discharge from the hospital;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Emergency services as described in COMAR 10.67.05.08B;</text> </paragraph> <paragraph num="(9)"> <text>Prenatal, intrapartum, and postpartum services performed at a free-standing birth center located in Maryland or a contiguous state; and</text> </paragraph> <paragraph num="(10)"> <text>Doula services, through December 31, 2025.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall pay undisputed claims of the SBHC for services provided to its participants within 30 days of the MCO's receipt of the invoice.</text> </paragraph> <paragraph num="C."> <text>An MCO shall provide SBHCs in its service area with the current information needed to facilitate communication between the SBHC, PCP, and the MCO regarding care provided to the MCO's participant, and to effect reimbursement by the MCO, including:</text> <paragraph num="(1)"> <text>Information concerning the MCO's policies and procedures regarding the provision of pharmacy and laboratory services;</text> </paragraph> <paragraph num="(2)"> <text>Instructions for submitting claims; and</text> </paragraph> <paragraph num="(3)"> <text>Contact information, including names and phone numbers of the following individuals:</text> <paragraph num="(a)"> <text>The MCO representative who serves as an SBHC's contact person for coordination of care; and</text> </paragraph> <paragraph num="(b)"> <text>The student-participant's PCP.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".29" heading="Optional Services."> <paragraph num="A."> <text>An MCO may provide its enrollees with additional health care services that are not required by this chapter.</text> </paragraph> <paragraph num="B."> <text>Optional health care services that an applicant intends to include in its benefits package shall be specified, including the terms and conditions for, and limitations to the provision of these services, in the applicant's initial application to the Department, as well as for periodic Departmental review.</text> </paragraph> <paragraph num="C."> <text>An MCO's provision of optional services that it has represented to be available to its enrollees is subject to monitoring of complaints and consumer satisfaction surveys, and to random audits.</text> </paragraph> <paragraph num="D."> <text>An MCO's provision of additional services that are not required by this regulation may not be taken into account when setting the MCO's capitation rate.</text> </paragraph> <paragraph num="E."> <text>Effective January 1, 2015, any changes to the health care services being offered by the MCO under §A of this regulation, including reducing or waiving pharmacy co-pays, shall be effective for an entire calendar year.</text> </paragraph> <paragraph num="F."> <text>An MCO shall notify the Department of any changes to their optional services by September 15 for the following calendar year.</text> </paragraph> <paragraph num="G."> <text>The Department may waive the requirement under §E of this regulation if the Department determines that the circumstance warrant, including but not limited to a reduction in rates outside the normal rate setting process.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".30" heading="Fertility Preservation."> <paragraph num="A."> <text>An MCO shall provide medically necessary fertility preservation services for the following individuals:</text> <paragraph num="(1)"> <text>Individuals who have iatrogenic infertility;</text> </paragraph> <paragraph num="(2)"> <text>Individuals who are receiving medical treatment that may directly or indirectly cause iatrogenic infertility; or</text> </paragraph> <paragraph num="(3)"> <text>Individuals who are receiving gender-affirming treatment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Fertility preservation services include sperm and oocyte cryopreservation and evaluations, laboratory assessments, medications, and treatments associated with sperm and oocyte cryopreservation.</text> </paragraph> <paragraph num="C."> <text>Fertility preservation services do not include the storage of sperm or oocytes.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".31" heading="Benefits — Telemedicine Services."> <text>An MCO shall provide to its enrollees medically necessary telemedicine services as described in COMAR 10.09.49.</text> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790)</annotation> <annotation type="History" subtype="Administrative History">Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.67 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .21A amended effective February 21, 2022 (49:4 Md. R. 300)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26 amended effective August 5, 2024 (51:15 Md. R, 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-1 amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-3 amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-6 adopted effective May 1, 2023 (50:8 Md. R. 337)</annotation> <annotation type="History" subtype="Administrative History">Regulation .26-7 adopted effective November 13, 2023 (50:22 Md. R. 974)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27 amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .27A amended effective April 28, 2025 (52:8 Md. R. 359)</annotation> <annotation type="History" subtype="Administrative History">Regulation .28A amended effective June 24, 2024 (51:12 Md. R. 618)</annotation> <annotation type="History" subtype="Administrative History">Regulation .30 adopted effective June 24, 2024 (51:12 Md. R. 620)</annotation> </annotations> </chapter> <chapter num="07" heading="Maryland Medicaid Managed Care Program: Program Integrity"> <regulation prefix="Regulation" num=".01" heading="Requirements to Detect and Prevent Fraud, Waste, and Abuse."> <paragraph num="A."> <text>An MCO or its responsible subcontractor shall implement and maintain arrangements or procedures that are designed to detect and prevent fraud, waste, and abuse, which includes a compliance program that has, at a minimum, the following elements:</text> <paragraph num="(1)"> <text>Written policies, procedures, and standards of conduct that include the MCO’s commitment to comply with all applicable:</text> <paragraph num="(a)"> <text>Requirements and standards under the contract; and</text> </paragraph> <paragraph num="(b)"> <text>Federal and State requirements including:</text> <paragraph num="(i)"> <text>Written policies for all employees and those of any contractor or agent that provide detailed information about the False Claims Act and other Federal and State laws described in §1902(a)(68) of the Social Security Act; and</text> </paragraph> <paragraph num="(ii)"> <text>Information about rights of employees to be protected as whistleblowers.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The designation of a compliance officer, who reports directly to the chief executive officer and the board of directors and is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements of the contract, and at minimum the following staff members:</text> <paragraph num="(a)"> <text>An investigator who is responsible for fraud, waste, and abuse investigations;</text> </paragraph> <paragraph num="(b)"> <text>An auditor who is responsible for identifying potential fraud, waste, and abuse through analysis of claims and related information; and</text> </paragraph> <paragraph num="(c)"> <text>An analyst capable of reviewing data and codes who is responsible for reviewing and researching evidence of potential fraud, waste, and abuse.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Staffing and resources located in Maryland to identify and investigate potential fraud, waste, and abuse, which shall be based on criteria determined by the Department that may include but are not limited to:</text> <paragraph num="(a)"> <text>Number of enrollees;</text> </paragraph> <paragraph num="(b)"> <text>Number of claims received on an annual basis;</text> </paragraph> <paragraph num="(c)"> <text>Volume of suspected fraudulent and abusive claims currently being detected;</text> </paragraph> <paragraph num="(d)"> <text>Other factors relating to the vulnerability of the MCO to fraud and abuse; and</text> </paragraph> <paragraph num="(e)"> <text>An assessment of optimal caseload which can be handled by an investigator on an annual basis.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The establishment of a regulatory compliance committee, which reports to the board of directors and to the MCO’s senior management level and is charged with overseeing the organization’s compliance program and its compliance with the requirements under the contract;</text> </paragraph> <paragraph num="(5)"> <text>A system for training and educating the compliance officer, the organization’s senior management, and the organization’s employees regarding the federal and State standards and requirements under the contract;</text> </paragraph> <paragraph num="(6)"> <text>Effective lines of communication between the compliance officer and the organization’s employees;</text> </paragraph> <paragraph num="(7)"> <text>Enforcement of standards through well-publicized disciplinary guidelines;</text> </paragraph> <paragraph num="(8)"> <text>Establishment and implementation of procedures and a system with dedicated staff for:</text> <paragraph num="(a)"> <text>Routine internal monitoring and auditing of compliance risks;</text> </paragraph> <paragraph num="(b)"> <text>Prompt response to compliance issues as they are raised;</text> </paragraph> <paragraph num="(c)"> <text>Investigation of potential compliance problems as identified in the course of self-evaluation and audits;</text> </paragraph> <paragraph num="(d)"> <text>Correction of problems, identified under §A(7)(c) of this regulation, promptly and thoroughly, or coordination of suspected criminal acts with law enforcement agencies, to reduce the potential for recurrence; and</text> </paragraph> <paragraph num="(e)"> <text>Ongoing compliance with the requirements under the contract.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall ensure that a subcontractor is legally qualified to furnish the services provided for in the subcontract.</text> </paragraph> <paragraph num="C."> <text>An MCO may not contract with the State unless conflict of interest safeguards at least equal to federal safeguards under section 27 of 41 U.S.C. §423, as amended, are in place.</text> </paragraph> <paragraph num="D."> <text>An MCO may not knowingly have a relationship of the type described in §E of this regulation with the following:</text> <paragraph num="(1)"> <text>An individual or entity that is debarred, suspended, or otherwise excluded from:</text> <paragraph num="(a)"> <text>Participating in procurement activities under the Federal Acquisition Regulation; or</text> </paragraph> <paragraph num="(b)"> <text>Participating in non-procurement activities under Executive Order Number 12549, 3 CFR 189 (1986); or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An individual or entity who is an affiliate, as defined in 48 CFR §2.101, of a person described in §D(1) of this regulation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The relationships described in §D of this Regulation, are as follows:</text> <paragraph num="(1)"> <text>A director, officer, or partner of the MCO;</text> </paragraph> <paragraph num="(2)"> <text>A subcontractor of the MCO;</text> </paragraph> <paragraph num="(3)"> <text>A person with beneficial ownership of 5 percent or more of the MCO’s equity; or</text> </paragraph> <paragraph num="(4)"> <text>A network provider or person with an employment, consulting or other arrangement with the MCO for the provision of items and services that is significant and material to the MCO’s obligations under its contract with the Department.</text> </paragraph> </paragraph> <paragraph num="F."> <text>An MCO may not have a relationship with an individual or entity that is excluded from participation in any Federal health care program under §1128 or 1128A of the Social Security Act.</text> </paragraph> <paragraph num="G."> <text>An MCO shall monitor the Department’s correspondence and any database publicizing Department-initiated terminations of providers from the Program.</text> </paragraph> <paragraph num="H."> <text>An MCO shall terminate the contract of, or refrain from contracting with, providers terminated or excluded from participation in the Program.</text> </paragraph> <paragraph num="I."> <text>An MCO shall suspend payments to a network provider for which the Department has determined that there is a credible allegation of fraud in accordance with 42 CFR §455.23.</text> </paragraph> <paragraph num="J."> <text>An MCO shall establish a system to verify, by sampling or other methods, whether services that have been represented to have been delivered by network providers were received by enrollees and shall apply such verification processes at least annually.</text> </paragraph> <paragraph num="K."> <text>An MCO shall require and have a mechanism for a network provider to report to the MCO when it has received an overpayment and to:</text> <paragraph num="(1)"> <text>Return the overpayment to the MCO within 60 calendar days after the date on which the overpayment was identified; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the MCO in writing of the reason for the overpayment.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Overpayments to Providers and Subcontractors.</text> <paragraph num="(1)"> <text>Overpayments recovered by an MCO, including those recovered due to waste, fraud and abuse, may be retained by the MCO, so long as it is reported to the Department.</text> </paragraph> <paragraph num="(2)"> <text>If the Department, Federal government, or its agents identified the potential fraud, waste, or abuse that leads to recovery of funds paid to an MCO provider, and the MCO did not previously identify and report the provider for potential overpayments, the State shall have the right to recover from the MCO the entire amount of the overpayment.</text> </paragraph> <paragraph num="(3)"> <text>The State shall have the sole right of recovery of an overpayment when the MCO has identified the overpayment and the MCO has not initiated recovery within 90 days after the completion of the MCO’s investigation.</text> </paragraph> <paragraph num="(4)"> <text>The MCO shall have the right to appeal, pursuant to COMAR 10.67.10.02, the Department’s recovery of an overpayment.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The Department has the authority to recover any overpayments made to MCOs.</text> </paragraph> <paragraph num="N."> <text>An MCO shall ensure that all of its network providers are screened, enrolled, and revalidated by the State as Medicaid providers, in accordance with 42 CFR part 455, subparts B and E.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Access to Information."> <paragraph num="A."> <text>An MCO, its subcontractors, and its subcontractor’s subcontractors shall permit the following organizations or their designees to inspect, evaluate, or audit books, records, contracts, computer or other electronic systems, premises, and facilities that pertain to the MCO’s Medicaid enrollees, and any aspect of services and activities performed, or determination of amounts payable under, the MCO’s contract with the Department:</text> <paragraph num="(1)"> <text>The Department and its agents;</text> </paragraph> <paragraph num="(2)"> <text>The Medicaid Fraud Control Unit of the Office of the Attorney General;</text> </paragraph> <paragraph num="(3)"> <text>The Insurance Fraud Division of the Maryland Insurance Administration;</text> </paragraph> <paragraph num="(4)"> <text>The Centers for Medicare and Medicaid Services;</text> </paragraph> <paragraph num="(5)"> <text>The Inspector General of the Department of Health and Human Services;</text> </paragraph> <paragraph num="(6)"> <text>The Comptroller General; and</text> </paragraph> <paragraph num="(7)"> <text>Other authorized State or federal agencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The right to inspect, audit, and evaluate shall exist for 10 years from the final date of the contract period or from the completion of any audit, whichever is later, except, if the Department, Centers for Medicare and Medicaid Services, or the Department of Health and Human Services Inspector General determines that there is a reasonable possibility of fraud, or similar risk, those agencies may inspect, audit, and evaluate at any time.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding §B of this regulation, the Department has the right to inspect the accuracy, truthfulness, and completeness of the encounter data submitted by, or on behalf of, the MCO.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Reporting."> <paragraph num="A."> <text>An MCO shall submit to the Department the following:</text> <paragraph num="(1)"> <text>Encounter data in the form and manner described in COMAR 10.67.04.15B, 42 CFR §438.242(c), and 42 CFR §438.818.</text> </paragraph> <paragraph num="(2)"> <text>Data required by the Department in order to certify the actuarial soundness of capitation rates to an MCO, under 42 CFR §438.3, including base data described in 42 CFR §438.5(c) that is generated by the MCO.</text> </paragraph> <paragraph num="(3)"> <text>Data required by the Department to determine compliance of the MCO with the medical loss ratio requirement described in 42 CFR §438.8.</text> </paragraph> <paragraph num="(4)"> <text>Data required by the Department and the Maryland Insurance Administration to determine that the MCO has made adequate provision against the risk of insolvency as required under 42 CFR §438.116.</text> </paragraph> <paragraph num="(5)"> <text>Documentation described in 42 CFR §438.207(b) on which the Department bases its certification that the MCO has complied with the State’s requirements for availability and accessibility of services, including the adequacy of the provider network, as set forth in 42 CFR §438.206.</text> </paragraph> <paragraph num="(6)"> <text>In accordance with §F of this regulation, information on ownership and control described in 42 CFR §455.104 from an MCO and its subcontractors, as governed by 42 CFR §438.230.</text> </paragraph> <paragraph num="(7)"> <text>An annual report of overpayment recoveries as required in 42 CFR §438.608(d)(3).</text> </paragraph> <paragraph num="(8)"> <text>Any other data, documentation, or information relating to the performance of the entity’s obligations under its contract with the Department, or required by the Department or the Secretary of the Department of Health and Human Services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall report to the Department any identified inaccuracies in the encounter data reported by the MCO or its subcontractors within 30 days of the date discovered regardless of the effect which the inaccuracy has upon MCO reimbursement.</text> </paragraph> <paragraph num="C."> <text>An MCO shall promptly report to the Department’s Office of Inspector General (OIG) any potential fraud, waste, abuse, or information it has received from whistleblowers relating to the integrity of the MCO, its network providers, or its subcontractors.</text> </paragraph> <paragraph num="D."> <text>An MCO shall report any potential fraud directly to the Medicaid Fraud Control Unit and the Department’s OIG, including fraud by providers, employees and subcontractors of the MCO, enrollment agents, and enrollees.</text> </paragraph> <paragraph num="E."> <text>After reporting any potential fraud, waste, or abuse to the Department’s OIG and to the Medicaid Fraud Control Unit, the MCO may not take the following actions without prior written approval from the State:</text> <paragraph num="(1)"> <text>Contact the subject of the investigation about any matter related to the investigation;</text> </paragraph> <paragraph num="(2)"> <text>Enter into or attempt to negotiate any settlement or agreement regarding the incident; or</text> </paragraph> <paragraph num="(3)"> <text>Accept any monetary or other type of consideration offered by the subject of the investigation in connection with the incident.</text> </paragraph> </paragraph> <paragraph num="F."> <text>For complaints of provider fraud and abuse that warrant a preliminary investigation, the MCO’s reports required in §§C and D of this regulation shall include:</text> <paragraph num="(1)"> <text>The number of complaints;</text> </paragraph> <paragraph num="(2)"> <text>The name and identification number of the provider being investigated;</text> </paragraph> <paragraph num="(3)"> <text>The source of the complaint;</text> </paragraph> <paragraph num="(4)"> <text>The type of provider;</text> </paragraph> <paragraph num="(5)"> <text>The nature of the complaint;</text> </paragraph> <paragraph num="(6)"> <text>The approximate dollar amount involved;</text> </paragraph> <paragraph num="(7)"> <text>The legal and administrative disposition of the case; and</text> </paragraph> <paragraph num="(8)"> <text>The method by which the MCO verified that the services being investigated were actually provided to the enrollee.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An MCO shall provide to the Department written disclosure of any affiliation prohibited under 42 CFR §438.610 and take action as directed by the Department.</text> </paragraph> <paragraph num="H."> <text>An MCO shall provide to the Department written disclosures of information on ownership and control required under 42 CFR §455.104, including:</text> <paragraph num="(1)"> <text>The following information for any individual or corporation with an ownership or control interest in the MCO:</text> <paragraph num="(a)"> <text>For individuals:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Address;</text> </paragraph> <paragraph num="(iii)"> <text>Date of birth; and</text> </paragraph> <paragraph num="(iv)"> <text>Social Security number; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For corporate entities:</text> <paragraph num="(i)"> <text>Name;</text> </paragraph> <paragraph num="(ii)"> <text>Applicable primary business address;</text> </paragraph> <paragraph num="(iii)"> <text>Every business location and applicable P.O. Box address; and</text> </paragraph> <paragraph num="(iv)"> <text>Other tax identification number or any subcontractor in which the MCO has a 5 percent or more interest;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Whether the individual or corporation with an ownership or control interest in the MCO:</text> <paragraph num="(a)"> <text>Is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling; or</text> </paragraph> <paragraph num="(b)"> <text>Whether the individual or corporation with an ownership or control interest in any subcontractor in which the MCO has a 5 percent or more interest is related to another person with ownership or control interest in the MCO as a spouse, parent, child, or sibling;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The name of any other MCO in which an owner of the MCO has an ownership or control interest;</text> </paragraph> <paragraph num="(4)"> <text>The name, address, date of birth, and Social Security number of any managing employee or agent of the MCO;</text> </paragraph> <paragraph num="(5)"> <text>Disclosures of ownership and control information from MCOs are due at the following times:</text> <paragraph num="(a)"> <text>Upon application;</text> </paragraph> <paragraph num="(b)"> <text>Upon the managed care entity executing the contract with the State;</text> </paragraph> <paragraph num="(c)"> <text>Upon renewal or extension of the contract; and</text> </paragraph> <paragraph num="(d)"> <text>Within 35 days after any change in ownership of the managed care entity.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>An MCO shall report to the Department all overpayments identified and recovered, specifying the overpayments due to fraud.</text> </paragraph> <paragraph num="J."> <text>An MCO shall report third-party liability collection activities as described in COMAR 10.67.04.18.</text> </paragraph> <paragraph num="K."> <text>An MCO shall report to the Department the amounts the MCO has cost-avoided and the number of third-party liability cases the MCO has handled.</text> </paragraph> <paragraph num="L."> <text>An MCO shall notify the Department promptly when it has knowledge of an enrollee’s change of residence or death.</text> </paragraph> <paragraph num="M."> <text>An MCO shall notify the Department promptly when the MCO receives information about a change in a network provider’s circumstances that may affect the network provider’s eligibility to participate in the Program, including the termination of the provider agreement with the MCO.</text> </paragraph> <paragraph num="N."> <text>An MCO shall submit all required data, documentation and information in the format specified by the Department.</text> </paragraph> <paragraph num="O."> <text>An MCO’s chief executive officer, chief financial officer, or directly-reporting authorized employee shall certify to the best of that individual’s information, knowledge, and belief, that any records, data, or other documents requested under regulations are accurate, complete and truthful.</text> </paragraph> <paragraph num="P."> <text>As directed by the Department’s OIG, the MCO shall submit written reports documenting its Program Integrity efforts, including but not limited to:</text> <paragraph num="(1)"> <text>The dollar amount of losses and recoveries attributable to overpayment, abuse, and fraud; and</text> </paragraph> <paragraph num="(2)"> <text>The number of referrals to the Department’s OIG during the prior State fiscal year.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.68 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="08" heading="Maryland Medicaid Managed Care Program: Non-Capitated Covered Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter describes the services that are not the responsibility of the MCOs but are covered by the Department on a fee-for-service basis.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Behavioral Health Non-Capitated Covered Services."> <paragraph num="A."> <text>An MCO is not responsible for reimbursing for the following substance use disorder services, regardless of diagnosis:</text> <paragraph num="(1)"> <text>Services delivered by a community-based provider as described in COMAR 10.09.80 with the following procedure codes:</text> </paragraph> <paragraph num="(2)"> <text>Substance use disorder services provided to children in an ICF-A with the revenue code 0100, Residential Services, child and adolescent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO is not responsible for reimbursing for the following services performed by free-standing laboratories, regardless of diagnosis:</text> <paragraph num="(1)"> <text>Presumptive drug tests; and</text> </paragraph> <paragraph num="(2)"> <text>Definitive drug tests.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO is not responsible for reimbursing for the laboratory services described in §B of this regulation unless billed by a:</text> <paragraph num="(1)"> <text>Primary care provider; or</text> </paragraph> <paragraph num="(2)"> <text>Other somatic care provider.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An MCO is not responsible for reimbursing for the following substance use disorder services if the MCO is billed with a primary diagnosis listed in §M of this regulation:</text> <paragraph num="(1)"> <text>Services delivered by an inpatient hospital with the following revenue codes:</text> </paragraph> <paragraph num="(2)"> <text>Services delivered by an outpatient hospital with the following revenue codes:</text> </paragraph> <paragraph num="(3)"> <text>Services delivered by an emergency department with the following revenue codes:</text> </paragraph> </paragraph> <paragraph num="E."> <text>An MCO is not responsible for reimbursing for mental health services with a primary diagnosis listed in §N of this regulation when the services are provided by a hospital and the services are the result of the treatment of mental health diagnosis.</text> </paragraph> <paragraph num="F."> <text>An MCO shall be responsible for reimbursing for behavioral health services delivered by the participant’s primary care provider.</text> </paragraph> <paragraph num="G."> <text>An MCO shall be responsible for reimbursing for somatic services related to gender identity disorder, including gender reassignment surgery.</text> </paragraph> <paragraph num="H."> <text>An MCO is not responsible for reimbursing the behavioral poisoning diagnoses listed in §P of this regulation in an emergency department setting.</text> </paragraph> <paragraph num="I."> <text>An MCO is not responsible for services billed by specialty mental health providers listed in COMAR 10.09.59 when the bill includes the specialty behavioral health diagnoses listed in §M or N in the primary diagnosis field.</text> </paragraph> <paragraph num="J."> <text>An MCO is not responsible for reimbursement of behavioral health crisis services as described in COMAR 10.09.16.</text> </paragraph> <paragraph num="K."> <text>An MCO is not responsible for behavioral health medications.</text> </paragraph> <paragraph num="L."> <text>An MCO is not responsible for reimbursing for services billed by a physician related to prescribing buprenorphine or Vivitrol when the following conditions are met:</text> <paragraph num="(1)"> <text>The physician delivering buprenorphine has a DATA 2000 waiver;</text> </paragraph> <paragraph num="(2)"> <text>The physician is not the participant’s primary care provider;</text> </paragraph> <paragraph num="(3)"> <text>The primary diagnosis is substance use disorder;</text> </paragraph> <paragraph num="(4)"> <text>The primary reason for the visit is substance use disorder treatment; and</text> </paragraph> <paragraph num="(5)"> <text>The procedure code listed on the claims is one of the following:</text> </paragraph> </paragraph> <paragraph num="M."> <text>Table of substance use disorder diagnoses, for dates of service on or after October 1, 2015:</text> </paragraph> <paragraph num="N."> <text>Table of mental health diagnoses, for dates of service on or after October 1, 2015:</text> </paragraph> <paragraph num="O."> <text>An MCO is not responsible for services billed by a psychiatrist when the claim includes one of the following primary diagnoses:</text> </paragraph> <paragraph num="P."> <text>Table of poisoning diagnoses, for dates of service on or after July 1, 2016:</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Nonbehavioral Health Fee-For-Service Benefits."> <text>An MCO may not be required to provide any of the following benefits or services that are reimbursed directly by the Department:</text> <paragraph num="A."> <text>The remaining days of a hospital admission following enrollment in the MCO if the recipient was admitted to the hospital before the date of the recipient's enrollment;</text> </paragraph> <paragraph num="B."> <text>Long-term care services except for those outlined in COMAR 10.67.06.07B and COMAR 10.67.06.12A;</text> </paragraph> <paragraph num="C."> <text>Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID) services;</text> </paragraph> <paragraph num="D."> <text>Personal care services pursuant to COMAR 10.09.20;</text> </paragraph> <paragraph num="E."> <text>Medical day care services, for adults and children;</text> </paragraph> <paragraph num="F."> <text>The following HIV/AIDS services:</text> <paragraph num="(1)"> <text>Genotypic, phenotypic, or other HIV/AIDS drug resistance testing used in the treatment of HIV/AIDS, if the service is:</text> <paragraph num="(a)"> <text>Rendered by a Department-approved provider; and</text> </paragraph> <paragraph num="(b)"> <text>Medically necessary; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Viral load testing used in treatment of HIV/AIDS.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Physical therapy, speech therapy, and occupational therapy services when:</text> <paragraph num="(1)"> <text>The enrollee is younger than 21 years old; and</text> </paragraph> <paragraph num="(2)"> <text>The services are not part of home health services or an inpatient hospital stay;</text> </paragraph> </paragraph> <paragraph num="H."> <text>Augmentative communication devices;</text> </paragraph> <paragraph num="I."> <text>All dental services including but not limited to outpatient surgery fees for the facility and general anesthesia.</text> </paragraph> <paragraph num="J."> <text>Except when a woman has been determined eligible for Medical Assistance benefits under COMAR 10.09.11, an abortion pursuant to COMAR 10.09.02.04G;</text> </paragraph> <paragraph num="K."> <text>Emergency transportation;</text> </paragraph> <paragraph num="L."> <text>Transportation services provided through grants to local governments pursuant to COMAR 10.09.19;</text> </paragraph> <paragraph num="M."> <text>Services provided to members participating in the State's Health Home Program as described in COMAR 10.09.33;</text> </paragraph> <paragraph num="N."> <text>Applied behavioral analysis (ABA) services as described in COMAR 10.09.28; and</text> </paragraph> <paragraph num="O."> <text>Abortions performed in accordance with Health-General Article, § 15-103, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.70 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1112); November 13, 2023 (50:23 Md. R. 1005)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I amended effective June 24, 2024 (51:12 Md. R. 620)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03M, N amended effective March 31, 2025 (52:6 Md. R. 267)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03O adopted effective March 31, 2025 (52:6 Md. R. 267)</annotation> </annotations> </chapter> <chapter num="09" heading="Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures"> <regulation prefix="Regulation" num=".01" heading="MCO Enrollee Services."> <text>An MCO shall:</text> <paragraph num="A."> <text>Maintain a member services unit that operates an enrollee services line at least during normal business hours;</text> </paragraph> <paragraph num="B."> <text>Operate its enrollee services line as a triage device to handle or properly refer enrollees' questions or complaints; and</text> </paragraph> <paragraph num="C."> <text>Provide information in the member handbook about how to use the MCO enrollee services line to obtain information and assistance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="MCO Enrollee Complaint Process."> <paragraph num="A."> <text>An MCO shall have written complaint procedures by which an enrollee who is dissatisfied with the MCO or its network providers, or decisions made by the MCO or a provider, may seek recourse verbally or in writing within the MCO at any time.</text> </paragraph> <paragraph num="B."> <text>An MCO shall:</text> <paragraph num="(1)"> <text>Submit its written internal complaint procedures to the Department for its approval;</text> </paragraph> <paragraph num="(2)"> <text>Give enrollees any reasonable assistance in completing forms and taking other procedural steps related to a grievance or appeal in a manner consistent with COMAR 10.67.05.01A;</text> </paragraph> <paragraph num="(3)"> <text>Prepare the document describing the MCO’s internal complaint process:</text> <paragraph num="(a)"> <text>In a culturally sensitive manner;</text> </paragraph> <paragraph num="(b)"> <text>At an appropriate reading comprehension level; and</text> </paragraph> <paragraph num="(c)"> <text>In the prevalent non-English languages, identified by the State;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Deliver a copy of the MCO’s complaint procedures to each enrollee:</text> <paragraph num="(a)"> <text>With the MCO’s initial contact with a new enrollee; and</text> </paragraph> <paragraph num="(b)"> <text>At any time upon an enrollee’s request;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Maintain an accurate and accessible record of grievances and appeals for monitoring by the State and CMS, which includes, at a minimum:</text> <paragraph num="(a)"> <text>A general description of the reason for the appeal or grievance;</text> </paragraph> <paragraph num="(b)"> <text>The date received;</text> </paragraph> <paragraph num="(c)"> <text>The date of each review or, if applicable, review meeting;</text> </paragraph> <paragraph num="(d)"> <text>Resolution at each level of the appeal or grievance, if applicable;</text> </paragraph> <paragraph num="(e)"> <text>Date of resolution at each level, if applicable; and</text> </paragraph> <paragraph num="(f)"> <text>Name of the enrollee for whom the appeal or grievance was filed; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provide in its written procedures that an enrollee may file appeals and grievances orally or in writing.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall submit for Department approval an internal complaint process detailing the procedures for registering and responding to appeals and grievances in a timely fashion, which:</text> <paragraph num="(1)"> <text>Includes a specific standard for grievance decisions, monitored by the MCO for compliance, directing that:</text> <paragraph num="(a)"> <text>The decision time for emergency medically related grievances may not exceed 24 hours;</text> </paragraph> <paragraph num="(b)"> <text>The decision time for nonemergency medically related grievances may not exceed 5 days; and</text> </paragraph> <paragraph num="(c)"> <text>For administrative grievances, the decision time may not exceed 30 days;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Includes participation by the provider, if appropriate;</text> </paragraph> <paragraph num="(3)"> <text>Allows participation by the ombudsman, if appropriate;</text> </paragraph> <paragraph num="(4)"> <text>Ensures the participation of individuals within the MCO who have the authority to require corrective action;</text> </paragraph> <paragraph num="(5)"> <text>Requires documentation of the substance of the grievances and steps taken;</text> </paragraph> <paragraph num="(6)"> <text>Includes a procedure for the aggregation and analysis of appeals and grievance data and use of the data for quality improvement;</text> </paragraph> <paragraph num="(7)"> <text>Includes a documented procedure for reporting:</text> <paragraph num="(a)"> <text>Appeals and grievances received by the MCO to:</text> <paragraph num="(i)"> <text>The provider involved;</text> </paragraph> <paragraph num="(ii)"> <text>Appropriate quality assurance committees and departments within the MCO;</text> </paragraph> <paragraph num="(iii)"> <text>The MCO's consumer advisory board; and</text> </paragraph> <paragraph num="(iv)"> <text>The Department as requested; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The quarterly appeal and grievance analysis performed by the MCO as specified in COMAR 10.67.04.15D(1)(b);</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Includes a documented procedure for written notification of the MCO's determination:</text> <paragraph num="(a)"> <text>To the enrollee who filed the grievance; and</text> </paragraph> <paragraph num="(b)"> <text>To those individuals and entities required to be notified of the grievance pursuant to §C(7) of this regulation;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Ensures that decision makers on appeals and grievances:</text> <paragraph num="(a)"> <text>Were not involved in previous levels of decision-making;</text> </paragraph> <paragraph num="(b)"> <text>Are not subordinates of people involved in previous levels of decision-making;</text> </paragraph> <paragraph num="(c)"> <text>Are healthcare professionals with clinical expertise in treating the enrollee’s condition or disease, if any of the following apply:</text> <paragraph num="(i)"> <text>The appeal is a denial based on lack of medical necessity;</text> </paragraph> <paragraph num="(ii)"> <text>The grievance is regarding denial of expedited resolution of an appeal; or</text> </paragraph> <paragraph num="(iii)"> <text>The appeal or grievance involves clinical issues; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Take into account all comments, documents, records, and other information submitted by the enrollee or their representative, without regard to whether such information was submitted or considered in the initial action.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02-1" heading="Member Complaints — Time Frames for MCOs to Respond to the Department."> <text>An MCO shall:</text> <paragraph num="A."> <text>Acknowledge an enrollee appeal or grievance reported to it by the Department’s complaint resolution unit within 1 business day;</text> </paragraph> <paragraph num="B."> <text>Respond to the Department’s request for information regarding disputed nonemergency medical care actions within 3 business days;</text> </paragraph> <paragraph num="C."> <text>Provide updates in a time frame specified by the Department;</text> </paragraph> <paragraph num="D."> <text>Provide medical records within 5 days of the request; and</text> </paragraph> <paragraph num="E."> <text>Provide a corrective action plan upon request and within the time frame specified, but not later than 10 days from the date of the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="MCO Provider Complaint Process."> <paragraph num="A."> <text>An MCO shall have a complaint procedure for providers that is:</text> <paragraph num="(1)"> <text>Documented in writing;</text> </paragraph> <paragraph num="(2)"> <text>Disseminated in writing to all of the MCO's providers at the time they join the MCO's provider panel, and furnished to a provider at any time, upon request; and</text> </paragraph> <paragraph num="(3)"> <text>Linked to the MCO's internal quality assurance program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An MCO shall include in its provider complaint process at least the following elements:</text> <paragraph num="(1)"> <text>Procedures for registering and responding to provider grievances in a timely fashion, including standards for timeliness that recognize the need for expedited determinations in situations that are time-sensitive, that is, when an enrollee's treatment outcome may be significantly affected by the promptness of treatment, as set forth in Regulation .02C(1)(a) and (b) of this chapter apply;</text> </paragraph> <paragraph num="(2)"> <text>Notification to the provider of an MCO's determination that affects the provider or that provider's patient, which includes a description of how to file an internal appeal with the MCO;</text> </paragraph> <paragraph num="(3)"> <text>Documentation of the substance of complaints and steps taken;</text> </paragraph> <paragraph num="(4)"> <text>Procedures to ensure the timely resolution of the complaint and response by the MCO to the provider;</text> </paragraph> <paragraph num="(5)"> <text>Procedures for the termination or withdrawal of a provider from the MCO's provider panel, including:</text> <paragraph num="(a)"> <text>At least 90 days prior notice to the primary care providers in the MCO's provider panel of the MCO's termination of a specialty services provider when the reason for the termination is unrelated to fraud, patient abuse, incompetency, or loss of licensure status;</text> </paragraph> <paragraph num="(b)"> <text>If possible, at least 90 days prior notice to the primary care providers in the MCO's provider panel of a specialty services provider's withdrawal from the MCO's provider panel; and</text> </paragraph> <paragraph num="(c)"> <text>Notices to primary care providers informing them of the enrollee’s right to change MCOs as described in COMAR 10.67.02.06A(1)(e).</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Mechanisms to aggregate and analyze appeal and grievance data and to use the data for quality improvement;</text> </paragraph> <paragraph num="(7)"> <text>An appeal process which:</text> <paragraph num="(a)"> <text>Is available when the provider's appeal or grievance is not resolved to the provider's satisfaction, or when the MCO acts to reduce, suspend, or terminate provider's privileges with the MCO;</text> </paragraph> <paragraph num="(b)"> <text>Acknowledges receipt of provider appeals within 5 business days of receipt by the MCO;</text> </paragraph> <paragraph num="(c)"> <text>Allows providers 90 business days from the date of a denial to file an initial appeal;</text> </paragraph> <paragraph num="(d)"> <text>Allows providers at least 15 business days from the date of denial to file each subsequent level of appeal;</text> </paragraph> <paragraph num="(e)"> <text>Resolves appeals, regardless of the number of appeal levels allowed by the MCO, within 90 business days of receipt of the initial appeal by the MCO;</text> </paragraph> <paragraph num="(f)"> <text>Pays claim within 30 days of the appeal decision when a claim denial is overturned;</text> </paragraph> <paragraph num="(g)"> <text>Provides at its final level an opportunity for the provider to be heard by the MCO's chief executive officer, or the chief executive officer's designee;</text> </paragraph> <paragraph num="(h)"> <text>Provides timely written notice to the provider of the results of the internal appeal; and</text> </paragraph> <paragraph num="(i)"> <text>Provides for written notice of the substance of the dispute and the result of the internal appeal to appropriate quality assurance committees and departments within the MCO; and</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A protocol for transmitting provider appeal and grievance reports and aggregate provider grievance and appeal data to the Department when requested.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO may not take any punitive action against a provider for utilizing the MCO provider complaint process, for supporting an enrollee's appeal, or for requesting expedited resolution for an enrollee's appeal.</text> </paragraph> <paragraph num="D."> <text>An MCO or its pharmacy benefits manager shall resolve pharmacy appeals concerning drug pricing within 21 days of the receipt of a request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03-1" heading="Independent Review Organization (IRO)."> <text>For provider disputes involving medical necessity, an MCO shall participate in the IRO process as specified in COMAR 10.67.13.</text> </regulation> <regulation prefix="Regulation" num=".03-2" heading="Provider Complaints — Time Frames for MCOs to Respond to the Department."> <text>An MCO shall:</text> <paragraph num="A."> <text>Acknowledge provider grievances within 3 business days;</text> </paragraph> <paragraph num="B."> <text>Provide findings to the Department within 5 days; and</text> </paragraph> <paragraph num="C."> <text>Provide a corrective action plan to the Department within 10 days from the date of the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="MCO Actions and Decisions."> <paragraph num="A."> <text>For certain services to enrollees that require preauthorization the following conditions apply:</text> <paragraph num="(1)"> <text>For standard authorization decisions, the MCO shall make a determination within 2 business days of receipt of necessary clinical information, but not later than 14 calendar days from the date of the initial request so as not to adversely affect the health of the enrollee;</text> </paragraph> <paragraph num="(2)"> <text>For expedited authorization decisions, the MCO shall make a determination and provide notice no later than 72 hours after receipt of the request for service if the provider indicates or the MCO determines that the standard time frame stated in §A(1) of this regulation could jeopardize:</text> <paragraph num="(a)"> <text>The enrollee’s life;</text> </paragraph> <paragraph num="(b)"> <text>The enrollee’s health; or</text> </paragraph> <paragraph num="(c)"> <text>The enrollee’s ability to attain, maintain, or regain maximum function;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For all covered outpatient drug authorization decisions, the MCO shall provide notice by telephone or other telecommunication device within 24 hours of a preauthorization request in accordance with section 1927(d)(5)(A) of the Social Security Act;</text> </paragraph> <paragraph num="(4)"> <text>Standard and expedited authorization decisions may be extended up to 14 calendar days, if the following conditions are met:</text> <paragraph num="(a)"> <text>The enrollee or the provider requests an extension; or</text> </paragraph> <paragraph num="(b)"> <text>The MCO justifies to the Department, upon request, a need for additional information and how the extension is in the enrollee’s interest; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the MCO successfully justifies extending the standard service authorization decision time frame, the MCO shall:</text> <paragraph num="(a)"> <text>Give the enrollee written notice of the reason for the decision to extend the time frame;</text> </paragraph> <paragraph num="(b)"> <text>Inform the enrollee of the right to file a grievance if he or she disagrees with the extension decision; and</text> </paragraph> <paragraph num="(c)"> <text>Issue and carry out the MCO’s determination as expeditiously as the enrollee’s health condition requires but not later than the date the extension expires.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested:</text> <paragraph num="(1)"> <text>Shall be made by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease; and</text> </paragraph> <paragraph num="(2)"> <text>May not be based solely on diagnosis, type of illness, or condition.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO shall ensure that compensation to individuals or entities that conduct utilization management activities is not structured to provide incentives for the individual or entity to deny, limit, or discontinue medically necessary services to any enrollee.</text> </paragraph> <paragraph num="D."> <text>Notices of a decision to deny a standard authorization shall be provided to the enrollee and the requesting provider within 72 hours from the date of determination.</text> </paragraph> <paragraph num="E."> <text>An MCO shall give an enrollee written notice of any action within the following time frames:</text> <paragraph num="(1)"> <text>At least 10 days before the action for termination, suspension, or reduction of a previously authorized covered service;</text> </paragraph> <paragraph num="(2)"> <text>The notice period is reduced to 5 days if probable enrollee fraud has been verified;</text> </paragraph> <paragraph num="(3)"> <text>By the date of the action for the following:</text> <paragraph num="(a)"> <text>The MCO has factual information confirming the death of an enrollee;</text> </paragraph> <paragraph num="(b)"> <text>A signed written enrollee statement requesting service termination or giving information requiring termination or reduction of services, where the enrollee understands that this is the result of supplying that information;</text> </paragraph> <paragraph num="(c)"> <text>The enrollee's admission to an institution where they are ineligible for further services;</text> </paragraph> <paragraph num="(d)"> <text>The enrollee's address is unknown and mail directed to the enrollee has no forwarding address;</text> </paragraph> <paragraph num="(e)"> <text>The enrollee has been accepted for Medicaid services by another jurisdiction;</text> </paragraph> <paragraph num="(f)"> <text>The enrollee's physician prescribes a change in the level of medical care; or</text> </paragraph> <paragraph num="(g)"> <text>An adverse determination made with regard to the preadmission screening requirements for nursing facility admissions; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>As soon as practicable for nursing facility transfers or discharges when:</text> <paragraph num="(a)"> <text>The safety or health of individuals in the facility would be endangered;</text> </paragraph> <paragraph num="(b)"> <text>The enrollee’s health improves sufficiently to allow a more immediate transfer or discharge; or</text> </paragraph> <paragraph num="(c)"> <text>An immediate transfer or discharge is required by the enrollee’s urgent medical needs; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For denial of payment, at the time of any action affecting the claim.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A notice of adverse action shall:</text> <paragraph num="(1)"> <text>Be in writing;</text> </paragraph> <paragraph num="(2)"> <text>Meet the following requirements:</text> <paragraph num="(a)"> <text>Be translated for enrollees who speak prevalent non-English languages;</text> </paragraph> <paragraph num="(b)"> <text>Include language clarifying that oral interpretation is available for all languages and how to access it;</text> </paragraph> <paragraph num="(c)"> <text>Be written in an easily understood language and format that takes into consideration enrollees with special needs;</text> </paragraph> <paragraph num="(d)"> <text>Be available in alternative formats; and</text> </paragraph> <paragraph num="(e)"> <text>Inform enrollees that information is available in alternative formats and how to access those formats; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Contain the following information:</text> <paragraph num="(a)"> <text>The action the MCO has made or intends to make;</text> </paragraph> <paragraph num="(b)"> <text>The reasons for the action, including the right for the enrollee to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the MCO’s action, including:</text> <paragraph num="(i)"> <text>Medical necessity criteria; and</text> </paragraph> <paragraph num="(ii)"> <text>Any processes, strategies, or evidentiary standards used in setting coverage limits;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The enrollee’s right to request an appeal of the MCO’s action, including information on:</text> <paragraph num="(i)"> <text>Exhausting the MCO’s one level of appeal; and</text> </paragraph> <paragraph num="(ii)"> <text>The right to request a State fair hearing;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The procedures for exercising the rights described;</text> </paragraph> <paragraph num="(e)"> <text>The circumstances under which an appeal process can be expedited and how to request it;</text> </paragraph> <paragraph num="(f)"> <text>The enrollee’s right to have benefits continue pending resolution of the appeal;</text> </paragraph> <paragraph num="(g)"> <text>How to request that benefits be continued; and</text> </paragraph> <paragraph num="(h)"> <text>The circumstances under which the enrollee may be required to pay the costs of the services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>If an MCO does not make an authorization decision within the times specified in §A of this regulation, the untimely decision is considered a denial and thus an adverse action subject to the notice requirements in §§C and E of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="MCO Appeal Process for Enrollees."> <paragraph num="A."> <text>An MCO's appeal process shall:</text> <paragraph num="(1)"> <text>Require that an enrollee, or a provider acting on the enrollee’s behalf, file an appeal within 60 days from the date on the MCO’s notice of action;</text> </paragraph> <paragraph num="(2)"> <text>Include procedures for acknowledging receipt of appeals within 5 business days;</text> </paragraph> <paragraph num="(3)"> <text>Permit an enrollee to request an appeal either orally or in writing;</text> </paragraph> <paragraph num="(4)"> <text>Provide that oral requests for appeal are considered the initiation of the appeal to establish the earliest possible filing date;</text> </paragraph> <paragraph num="(5)"> <text>Provide reasonable opportunity to present evidence and allegations of fact or law, in person as well as in writing, and in the case of expedited appeals, the MCO shall inform the enrollee of the limited time available for the enrollee to present this evidence;</text> </paragraph> <paragraph num="(6)"> <text>Provide the case file upon request to the enrollee and the enrollee's representative, free of charge and sufficiently in advance of the resolution time frame for appeals, which includes:</text> <paragraph num="(a)"> <text>Medical records;</text> </paragraph> <paragraph num="(b)"> <text>Other documents and records; and</text> </paragraph> <paragraph num="(c)"> <text>Any new or additional evidence considered, relied upon, or generated by the MCO in connection with the action.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Allow a provider or authorized representative acting on behalf of an enrollee to file an appeal with the enrollee’s written consent;</text> </paragraph> <paragraph num="(8)"> <text>Consider the enrollee, the enrollee's representative, or the estate representative of a deceased enrollee as parties to the appeal;</text> </paragraph> <paragraph num="(9)"> <text>Establish and maintain an expedited review process, when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize the enrollee’s life, physical or mental health, or ability to attain, maintain, or regain maximum function; and</text> </paragraph> <paragraph num="(10)"> <text>Ensure that punitive action is not taken against a provider who requests an expedited resolution or supports an enrollee’s appeal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Resolution.</text> <paragraph num="(1)"> <text>Except for expedited appeals as described in §C, an MCO shall resolve each appeal and provide notice of resolution, as expeditiously as the enrollee’s health condition requires, and unless extended pursuant to §B(2) of this regulation, within 30 days from the day the MCO receives the appeal.</text> </paragraph> <paragraph num="(2)"> <text>The time frames in §B(1) of this regulation may be extended up to 14 calendar days if:</text> <paragraph num="(a)"> <text>The enrollee requests the extension; or</text> </paragraph> <paragraph num="(b)"> <text>The MCO shows, upon the Department's request, that there is a need for additional information and how the delay is in the enrollee's interest.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>For any extension not requested by the enrollee, the MCO shall:</text> <paragraph num="(a)"> <text>Give the enrollee written notice; and</text> </paragraph> <paragraph num="(b)"> <text>Make reasonable efforts to give the enrollee verbal notice of the reason for the delay.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Continuation of Benefits. The MCO shall continue the enrollee’s benefits pending the outcome of the appeal if all of the following occur:</text> <paragraph num="(a)"> <text>The enrollee timely files for continuation of benefits;</text> </paragraph> <paragraph num="(b)"> <text>The appeal is filed timely, meaning on or before the later of the following:</text> <paragraph num="(i)"> <text>Within 10 days of the MCO mailing the notice of action; or</text> </paragraph> <paragraph num="(ii)"> <text>The intended effective date of the MCO's proposed action;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The appeal involves the termination, suspension, or reduction of a previously authorized service;</text> </paragraph> <paragraph num="(d)"> <text>The services were ordered by an authorized provider; and</text> </paragraph> <paragraph num="(e)"> <text>The authorization period has not expired.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>If the MCO continues or reinstates the enrollee's benefits while the appeal is pending, the benefits shall continue until one of the following occurs:</text> <paragraph num="(a)"> <text>The enrollee withdraws the appeal;</text> </paragraph> <paragraph num="(b)"> <text>The enrollee fails to request a State fair hearing and continuation of benefits within 10 days after the MCO sends the notice of an adverse resolution to the enrollee’s appeal; or</text> </paragraph> <paragraph num="(c)"> <text>A State fair hearing decision adverse to the enrollee is made.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>If the MCO or State fair hearing officer reverses a decision to deny, limit, or delay services, the MCO shall authorize or provide the disputed services promptly and as expeditiously as the enrollee’s health condition requires but no later than 72 hours of the date the MCO receives the reversal.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Expedited Appeals.</text> <paragraph num="(1)"> <text>An expedited resolution may be approved when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize:</text> <paragraph num="(a)"> <text>The enrollee’s life;</text> </paragraph> <paragraph num="(b)"> <text>The enrollee’s physical or mental health; or</text> </paragraph> <paragraph num="(c)"> <text>The enrollee’s ability to attain, maintain, or regain maximum function.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Expedited appeals shall be resolved as expeditiously as the enrollee’s health condition requires but no later than 72 hours after the MCO receives the appeal.</text> </paragraph> <paragraph num="(3)"> <text>If the MCO denies a request for expedited resolution of an appeal, the MCO shall:</text> <paragraph num="(a)"> <text>Transfer the appeal to the standard time frame of not longer than 30 days from the day the MCO receives the appeal with a possible 14-day extension as described in §B(2) of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Make reasonable efforts to give the enrollee prompt verbal notice of the denial of expedited resolution and provide a written notice within 2 calendar days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Notification.</text> <paragraph num="(1)"> <text>The MCO shall provide written notice of resolution which includes:</text> <paragraph num="(a)"> <text>The results and date of the appeal resolution;</text> </paragraph> <paragraph num="(b)"> <text>The reasons for the action;</text> </paragraph> <paragraph num="(c)"> <text>For decisions not wholly in the enrollee’s favor:</text> <paragraph num="(i)"> <text>The right to request a State fair hearing;</text> </paragraph> <paragraph num="(ii)"> <text>How to request a State fair hearing;</text> </paragraph> <paragraph num="(iii)"> <text>The right to continue to receive benefits pending a hearing;</text> </paragraph> <paragraph num="(iv)"> <text>How to request the continuation of benefits; and</text> </paragraph> <paragraph num="(v)"> <text>A statement that the enrollee may be liable for the cost of any continued benefits if the MCO's action is upheld in a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For notice of an expedited resolution, in addition to requirements listed in §D(1) of this regulation, the MCO shall also make reasonable efforts to provide oral notice of the decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If an MCO fails to adhere to the notice and timing requirements, as described in §§A—D of this regulation, the enrollee is deemed to have exhausted the MCO’s appeals process and may initiate a State fair hearing.</text> </paragraph> <paragraph num="F."> <text>State Fair Hearing.</text> <paragraph num="(1)"> <text>An enrollee may exercise State fair hearing rights pursuant to the Department’s regulations and State Government Article, §10-201 et seq., Annotated Code of Maryland, subject to the requirements of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>An enrollee may request a State fair hearing for an MCO appeal resolution after first exhausting the MCO’s appeal process by appealing to the Office of Administrative Hearings using the process specified in COMAR 10.01.04.</text> </paragraph> <paragraph num="(3)"> <text>An enrollee shall file for a State fair hearing within 120 days from the date the MCO provides on the written notice of appeal resolution.</text> </paragraph> <paragraph num="(4)"> <text>The parties to an appeal to the Office of Administrative Hearings under this section are the:</text> <paragraph num="(a)"> <text>MCO;</text> </paragraph> <paragraph num="(b)"> <text>Enrollee; and</text> </paragraph> <paragraph num="(c)"> <text>Enrollee’s representative or the personal representative of a deceased enrollee’s estate.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The MCO shall provide documentation regarding medical determinations to enrollees and the Office of Administrative Hearings as required by COMAR 10.01.04 and other applicable law.</text> </paragraph> <paragraph num="(6)"> <text>The MCO shall continue the enrollee’s benefits pending the outcome of the State fair hearing if all of the following occur:</text> <paragraph num="(a)"> <text>The enrollee files for continuation of benefits within 10 days of the MCO upholding its action;</text> </paragraph> <paragraph num="(b)"> <text>The State fair hearing request is filed timely, meaning on or before the later of the following:</text> <paragraph num="(i)"> <text>10 days from the date on the MCO’s notice of appeal resolution; or</text> </paragraph> <paragraph num="(ii)"> <text>The intended effective date of the MCO's proposed action;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>The State fair hearing involves the termination, suspension, or reduction of a previously authorized service;</text> </paragraph> <paragraph num="(d)"> <text>The services were ordered by an authorized provider; and</text> </paragraph> <paragraph num="(e)"> <text>The authorization period has not expired.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>If the MCO continues or reinstates the enrollee's benefits while the State fair hearing is pending, the benefits shall continue until one of the following occurs:</text> <paragraph num="(a)"> <text>The enrollee withdraws the State fair hearing; or</text> </paragraph> <paragraph num="(b)"> <text>A State fair hearing decision adverse to the enrollee is issued by the Office of Administrative Hearings.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The final decision of the Office of Administrative Hearings is appealable to the circuit court, and is governed by State Government Article, §10-201 et seq., Annotated Code of Maryland, and the Maryland Rules.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The Department may order an MCO to provide a benefit or service based on its evaluation of the MCO’s action.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-103(b)(9)(i)(4), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.71 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D adopted effective May 18, 2020 (47:10 Md. R. 515)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, D amended effective November 18, 2019 (46:23 Md. R. 1065)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective June 13, 2022 (49:12 Md. R. 641)</annotation> </annotations> </chapter> <chapter num="10" heading="Maryland Medicaid Managed Care Program: Sanctions"> <regulation prefix="Regulation" num=".01" heading="Sanction by the Department."> <paragraph num="A."> <text>If the Department determines, after a sufficient investigation, that an MCO or any agent or employee of the MCO, or any person with an ownership interest in an MCO, or related party of the MCO, has failed to comply with any applicable law, regulation, or contract term, or for other good cause shown, the Department may impose sanctions on the MCO, including but not limited to:</text> <paragraph num="(1)"> <text>Fines;</text> </paragraph> <paragraph num="(2)"> <text>Suspension of further enrollment;</text> </paragraph> <paragraph num="(3)"> <text>Withholding all or part of the capitation payment;</text> </paragraph> <paragraph num="(4)"> <text>Termination of the current HealthChoice Managed Care Organization Agreement;</text> </paragraph> <paragraph num="(5)"> <text>Disqualification from future participation in the Maryland Medicaid Managed Care Program;</text> </paragraph> <paragraph num="(6)"> <text>Orders to provide a benefit or service to enrollees; and</text> </paragraph> <paragraph num="(7)"> <text>Those outlined in 42 CFR §§438.700—438.708, as amended.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Corrective Action.</text> <paragraph num="(1)"> <text>Subject to §B(2) of this regulation, before imposing a sanction pursuant to §A of this regulation, the Department may permit an MCO an opportunity to take corrective action in accordance with a plan approved by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The MCO shall submit a corrective action plan within a time frame specified by the Department.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".01-1" heading="Sanction by Center for Medicare and Medicaid Services (CMS)."> <text>The Department shall comply with notification requirements of CMS at 42 CFR §438.730 for sanction determinations as specified in 42 CFR §438.700(b)(1)—(b)(6).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Appeal."> <paragraph num="A."> <text>From the decisions set forth in §B(1)—(8) of this regulation, an MCO may exercise the appeal rights set forth in §C of this regulation.</text> </paragraph> <paragraph num="B."> <text>The following Department decisions are appealable by the MCO or MCO applicant:</text> <paragraph num="(1)"> <text>Denial of an entity’s completed application to become an MCO;</text> </paragraph> <paragraph num="(2)"> <text>Decision to terminate the MCO's participation in the Maryland Medicaid Managed Care Program;</text> </paragraph> <paragraph num="(3)"> <text>Decision to impose a fine valued at $50,000 or more on the MCO as described in Regulation .01 of this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Order that the MCO is impaired or in “hazardous financial condition”;</text> </paragraph> <paragraph num="(5)"> <text>An adverse decision by the IRO as described in COMAR 10.67.13.08;</text> </paragraph> <paragraph num="(6)"> <text>The denial of a hepatitis C payment as described in COMAR 10.67.04.19;</text> </paragraph> <paragraph num="(7)"> <text>Overpayments recovered by the Department as described in COMAR 10.67.07.01; and</text> </paragraph> <paragraph num="(8)"> <text>Remittances to the Department as described in COMAR 10.67.04.19-5.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An MCO may appeal a decision listed in §B of this regulation to the Office of Administrative Hearings as specified in COMAR 10.01.03 and COMAR 10.09.36.09.</text> </paragraph> <paragraph num="D."> <text>The parties to an appeal to the Office of Administrative Hearings under §C of this regulation are the Department and the MCO. The enrollee is not a party at this hearing.</text> </paragraph> <paragraph num="E."> <text>The following sanctions shall take effect immediately and are not subject to stay during the pendency of an appeal:</text> <paragraph num="(1)"> <text>Any fines imposed;</text> </paragraph> <paragraph num="(2)"> <text>Any full or partial withhold of the capitation payment;</text> </paragraph> <paragraph num="(3)"> <text>Any remittances to the Department as described in COMAR 10.67.04.19-5; or</text> </paragraph> <paragraph num="(4)"> <text>Any overpayments recovered by the Department as described in COMAR 10.67.07.01.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Incentives."> <paragraph num="A."> <text>All monies collected from the MCOs as a result of the imposition of a financial sanction shall be deposited in the HealthChoice Performance Incentive Fund.</text> </paragraph> <paragraph num="B."> <text>This nonlapsing fund shall include all sanctions imposed on the MCOs starting in calendar year 1999.</text> </paragraph> <paragraph num="C."> <text>The fund shall be used to provide financial incentive awards to the MCOs that meet or exceed specific performance targets as established by the Department, unless otherwise directed by law.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-103(b)(9), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.73 effective November 1, 2019 (46:22 Md. R. 977)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective April 28, 2025 (52:8 Md. R. 359)</annotation> </annotations> </chapter> <chapter num="11" heading="Maryland Medicaid Managed Care Program: Contribution to Graduate Medical Education Costs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter applies to teaching hospitals that provide health care services to recipients enrolled in Maryland Medicaid Managed Care Program MCOs.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="GME Allocation Payment."> <paragraph num="A."> <text>Purpose. GME allocation payments to teaching hospitals are intended to:</text> <paragraph num="(1)"> <text>Reaffirm the Program's historic commitment to preserving graduate medical education at each of the State's teaching hospitals, by maintaining Program payments supporting graduate medical education at levels equivalent to inflation-adjusted FY 1995 expenditures;</text> </paragraph> <paragraph num="(2)"> <text>Promote the training of primary care practitioners;</text> </paragraph> <paragraph num="(3)"> <text>Promote the development of innovative approaches to improve the Program population's access to health care services; and</text> </paragraph> <paragraph num="(4)"> <text>Ameliorate the new funding procedure's impact on MCOs that historically have experienced low utilization of teaching hospitals, by adopting an initial moderate reduction, pursuant to §B(4) of this regulation and COMAR 10.67.05.15, of the amount of GME-allocatable dollars included in teaching hospitals' GME allocation payments during the first 3 years of separate GME funding.</text> </paragraph> </paragraph> <paragraph num="B."> <text>GME Allocation Payments to Teaching Hospitals. Beginning in FY 1999, the Department shall, on a quarterly basis, pay each teaching hospital a GME allocation payment, calculated as follows:</text> <paragraph num="(1)"> <text>The Department shall calculate the combined dollar amount of payments made by the Program to teaching hospitals during FY 1995, including only those payments attributable to utilization:</text> <paragraph num="(a)"> <text>Of services that, if delivered during the fiscal year during which the GME allocation payment is made, would be included in the Maryland Medicaid Managed Care Program mandatory benefits package established by COMAR 10.67.06; and</text> </paragraph> <paragraph num="(b)"> <text>By recipients who, if the utilization had occurred during the fiscal year in which the GME allocation payment is made:</text> <paragraph num="(i)"> <text>Would have met the eligibility criteria for the Maryland Medicaid Managed Care Program, pursuant to COMAR 10.67.02.01; and</text> </paragraph> <paragraph num="(ii)"> <text>Would not have met the eligibility criteria for the rare and expensive case management program, pursuant to COMAR 10.09.69.03;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>The amount resulting from the calculation described in §B(1) of this regulation is reduced by the dollar amount of included payments for inpatient hospital services that, if they had been incurred during the fiscal year of the GME allocation payment, would have been subject to avoidance by an MCO pursuant to the stop-loss provisions of COMAR 10.67.04.22;</text> </paragraph> <paragraph num="(3)"> <text>The amount resulting from the calculation described in §B(2) of this regulation is trended forward to adjust for the time differential between the base year (FY 1995) and the contract year;</text> </paragraph> <paragraph num="(4)"> <text>The amount resulting from the calculation described in §B(3) of this regulation is reduced to reflect the managed care discount incorporated into capitation rates pursuant to COMAR 10.67.04.18-1B(2);</text> </paragraph> <paragraph num="(5)"> <text>The amount resulting from the calculation described in §B(4) of this regulation is multiplied by the percentage of Program payments considered, pursuant to COMAR 10.67.04.18-1A(1)—(3), to be attributable to GME; and</text> </paragraph> <paragraph num="(6)"> <text>The amount resulting from the calculation described in §B(5) of this regulation is multiplied by 0.25, to reflect the GME allocation's quarterly payment schedule.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §15-103(b)(18), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective December 24, 2001 (28:25 Md. R. 2190)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.74 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="12" heading="Maryland Medicaid Managed Care Program: Corrective Managed Care"> <regulation prefix="Regulation" num=".01" heading="General."> <paragraph num="A."> <text>An MCO shall establish a corrective managed care plan that, at minimum, provides for:</text> <paragraph num="(1)"> <text>The identification of an enrollee that has abused MCO pharmacy benefits; and</text> </paragraph> <paragraph num="(2)"> <text>The enrollment of an enrollee that has been determined to have abused MCO pharmacy benefits in the MCO’s corrective managed care plan.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Enrollee abuse exists when an enrollee:</text> <paragraph num="(1)"> <text>Has engaged in behaviors identified in COMAR 10.09.24.14-1; or</text> </paragraph> <paragraph num="(2)"> <text>Engages in Medicaid fraud as defined under COMAR 10.09.24.14.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Corrective Managed Care Plan."> <paragraph num="A."> <text>An MCO’s corrective managed care plan:</text> <paragraph num="(1)"> <text>Shall cover enrollee abuse of medical assistance pharmacy benefits; and</text> </paragraph> <paragraph num="(2)"> <text>May cover enrollee abuse of nonpharmacy medical assistance benefits.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For all benefit abuse covered by an MCO’s corrective managed care plan, the plan shall:</text> <paragraph num="(1)"> <text>Use the criteria as described in Regulation .01B of this regulation to determine if enrollees have abused benefits;</text> </paragraph> <paragraph num="(2)"> <text>Provide for a medical review of the alleged abuse consistent with §C of this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Provide that an enrollee found to have abused benefits will be enrolled in the program for 24 months;</text> </paragraph> <paragraph num="(4)"> <text>Provide that an enrollee who has been enrolled in a 24 month plan and is subsequently found to have abused MCO benefits shall be enrolled in the plan for an additional 36 months;</text> </paragraph> <paragraph num="(5)"> <text>Provide for the MCO to select any participating provider in the MCO that meets the requirements of COMAR 10.67.05.05A to serve as the enrollee’s primary care, specialty care, and pharmacy providers for enrollees in corrective managed care, as appropriate to the type of benefit the enrollee has been found to have abused;</text> </paragraph> <paragraph num="(6)"> <text>Require an enrollee to obtain prescribed drugs only from a single designated pharmacy provider, which may be any pharmacy or any single branch of a pharmacy chain that participates in the MCO and meets the requirements of COMAR 10.67.05.06B and .07C(2) unless the prescription is:</text> <paragraph num="(a)"> <text>Pursuant to an emergency department visit;</text> </paragraph> <paragraph num="(b)"> <text>Pursuant to hospital inpatient treatment; or</text> </paragraph> <paragraph num="(c)"> <text>A specialty drug as defined in COMAR 10.67.06.04;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Provide enrollees determined to have abused benefits the ability to suggest primary care, specialty care, or pharmacy providers;</text> </paragraph> <paragraph num="(8)"> <text>Require the MCO to accept the enrollee’s suggestion referenced in §B(7) of this regulation unless the MCO determines that the recipient’s choice of provider would not serve the enrollee’s best interest in achieving appropriate use of the health care systems and benefits available through the MCO;</text> </paragraph> <paragraph num="(9)"> <text>Provide an enrollee determined to have abused benefits 20 days from the date of the notice to present additional documentation to explain the facts that serve as the basis for the MCO’s determination of benefit abuse, consistent with §D of this regulation;</text> </paragraph> <paragraph num="(10)"> <text>Provide for the designation of a new primary care, specialty care, or pharmacy provider if the enrollee moves out of the service area of the current primary care or pharmacy provider;</text> </paragraph> <paragraph num="(11)"> <text>Provide for prompt reporting to the Department the name of any enrollee enrolled in the MCO’s program, the duration of enrollment, or any change in the duration of enrollment; and</text> </paragraph> <paragraph num="(12)"> <text>Be submitted to the Department for review and approval:</text> <paragraph num="(a)"> <text>Within 60 days of the effective date of this regulation; and</text> </paragraph> <paragraph num="(b)"> <text>Before the implementation of any modification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The medical review required in §B(2) of this regulation shall:</text> <paragraph num="(1)"> <text>Be performed by a medical reviewer who is a licensed health care professional;</text> </paragraph> <paragraph num="(2)"> <text>Consider all information that is relevant and available to the MCO, including but not limited to MCO payment records and information secured from any interviews conducted; and</text> </paragraph> <paragraph num="(3)"> <text>Where appropriate, consider records obtained from other sources, including:</text> <paragraph num="(a)"> <text>Providers of medical services;</text> </paragraph> <paragraph num="(b)"> <text>Statistical reports;</text> </paragraph> <paragraph num="(c)"> <text>Outside complaints;</text> </paragraph> <paragraph num="(d)"> <text>Referrals from other agencies; or</text> </paragraph> <paragraph num="(e)"> <text>Any other appropriate sources.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If an enrollee provides additional information pursuant to §B(9) of this regulation within 20 days:</text> <paragraph num="(1)"> <text>The effective date of the enrollment provided in the notice shall be tolled pending the MCO’s review of the additional information;</text> </paragraph> <paragraph num="(2)"> <text>The MCO shall consider whether the additional information changes the MCO’s determination regarding the appropriateness of the enrollee’s enrollment in corrective managed care;</text> </paragraph> <paragraph num="(3)"> <text>The MCO shall notify the enrollee of its decision whether the MCO is affirming or reversing its determination to enroll the enrollee in corrective managed care; and</text> </paragraph> <paragraph num="(4)"> <text>If the MCO confirms its determination to enroll the enrollee in corrective managed care, the notice shall:</text> <paragraph num="(a)"> <text>Identify the effective date and duration of that enrollment; and</text> </paragraph> <paragraph num="(b)"> <text>Include an explanation of the enrollee’s right to appeal the determination as described in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>An MCO’s corrective managed care plan may include a process for re-considering, at any interval of time, a decision to enroll an enrollee in the MCO’s corrective managed care plan, if the process entitles the enrollee to appeal the decision pursuant to Regulation .05 of this chapter at the same interval of time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Enrollee Notice."> <text>The MCO shall provide an enrollee determined to have abused MCO benefits a written notice that includes the following:</text> <paragraph num="A."> <text>An explanation of the reason or reasons for the determination that the enrollee abused benefits;</text> </paragraph> <paragraph num="B."> <text>A statement that the enrollee has 20 days to provide:</text> <paragraph num="(1)"> <text>Additional information for the MCO to consider before enrollment will become effective; and</text> </paragraph> <paragraph num="(2)"> <text>The address where the additional information shall be sent;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A statement that the enrollee will be enrolled in corrective managed care and the effective date and duration of that enrollment;</text> </paragraph> <paragraph num="D."> <text>An explanation that the effective date will be tolled pending the MCO's review of any additional information the enrollee provides pursuant to §B of this regulation;</text> </paragraph> <paragraph num="E."> <text>A statement that the enrollee may identify a preference for an assigned primary medical care provider, specialty care provider, or pharmacy; and</text> </paragraph> <paragraph num="F."> <text>An explanation of the enrollee’s right to appeal the MCO’s determination as described in Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Effective Date of Enrollment."> <paragraph num="A."> <text>Except as provided in §B of this regulation, the effective date of enrollment shall be 20 days from the date of the notice described in Regulation .03A and B of this chapter, whichever is later.</text> </paragraph> <paragraph num="B."> <text>If an enrollee determined to have abused benefits appeals the determination, the effective date of the enrollment shall be tolled pending the outcome of the appeal.</text> </paragraph> <paragraph num="C."> <text>The duration of an enrollee’s enrollment in a plan may not be altered because of changes in how the individual receives medical assistance, including but not limited to a change in the enrollee’s MCO enrollment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Enrollee Appeal."> <paragraph num="A."> <text>An enrollee shall have 20 days to appeal an MCO’s determination of benefit abuse.</text> </paragraph> <paragraph num="B."> <text>Except for the time frame specified in §A of this regulation, an appeal shall be handled as specified in COMAR 10.67.09.05.</text> </paragraph> <paragraph num="C."> <text>If the appeal results in a hearing, an MCO shall:</text> <paragraph num="(1)"> <text>Attend the hearing; and</text> </paragraph> <paragraph num="(2)"> <text>Provide justification for enrollment in the program.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§15-102.1(b)(9) and 15-103, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 2, 2004 (31:2 Md. R. 82)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.75 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> <chapter num="13" heading="Maryland Medicaid Managed Care Program: Independent Review Organization (IRO)"> <regulation prefix="Regulation" num=".01" heading="Scope and Purpose."> <text>This chapter provides for a complaint resolution process for disputes between managed care organizations (MCOs) and providers regarding adverse medical necessity decision made by MCOs. Pursuant to this chapter, providers that receive an adverse medical necessity decision on claims for reimbursement may submit the adverse decision for review by an Independent Review Organization (IRO) designated by the Department.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adverse decision” means a review determination by a managed care organization that a health care service for which a provider seeks reimbursement is not medically necessary.</text> </paragraph> <paragraph num="(2)"> <text>“Affiliate” means a person who, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with another person.</text> </paragraph> <paragraph num="(3)"> <text>“Case record” means documentation submitted to an independent review organization consisting of:</text> <paragraph num="(a)"> <text>A claim and only the supporting documentation, including medical records, originally submitted to a managed care organization by a provider prior to the managed care organization’s adverse decision on the claim;</text> </paragraph> <paragraph num="(b)"> <text>The managed care organization’s adverse decision; and</text> </paragraph> <paragraph num="(c)"> <text>The managed care organization’s written rationale for the adverse decision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Claim” means a clean claim as defined in COMAR 31.10.11.02.</text> </paragraph> <paragraph num="(5)"> <text>“Complaint” means an appeal of an adverse decision filed with the independent review organization.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Expert reviewer” means a physician or other appropriate health care provider who contracts with the independent review organization to conduct a review of a managed care organization’s adverse decision.</text> </paragraph> <paragraph num="(8)"> <text>“Health care service” means a health or medical care procedure or service rendered by a provider including:</text> <paragraph num="(a)"> <text>Testing, diagnosis, or treatment of a human disease or dysfunction;</text> </paragraph> <paragraph num="(b)"> <text>Dispensing of drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; or</text> </paragraph> <paragraph num="(c)"> <text>Any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well-being of human beings.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Independent review organization” means an entity that contracts with the Department to conduct independent review of managed care organizations’ adverse decisions.</text> </paragraph> <paragraph num="(10)"> <text>“Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Medicaid” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for persons.</text> </paragraph> <paragraph num="(12)"> <text>“Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Medically necessary” means a health care service that is:</text> <paragraph num="(a)"> <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text> </paragraph> <paragraph num="(b)"> <text>Consistent with currently accepted standards of good medical practice;</text> </paragraph> <paragraph num="(c)"> <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text> </paragraph> <paragraph num="(d)"> <text>Not primarily for the convenience of the consumer, the consumer's family, or the provider.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Provider” means any individual or entity that has a valid provider agreement with a Medicaid managed care organization or is a nonparticipating provider rendering covered Medicaid services to the managed care organization’s enrollees.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Use of Independent Review Organizations."> <paragraph num="A."> <text>The Department shall procure the services of an IRO to make determinations of medical necessity on provider complaints regarding adverse decisions.</text> </paragraph> <paragraph num="B."> <text>An IRO that contracts with the Department shall assure, in accordance with its contract with the Department, the:</text> <paragraph num="(1)"> <text>Timeliness and quality of the reviews;</text> </paragraph> <paragraph num="(2)"> <text>Qualifications and independence of the IRO and expert reviewers; and</text> </paragraph> <paragraph num="(3)"> <text>Confidentiality of medical records and review materials, consistent with federal and State laws.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An IRO designated by the Department shall have the authority to conduct the following functions:</text> <paragraph num="(1)"> <text>Obtaining all case information relative to the complaint from the MCO pursuant to time frames established by the Department;</text> </paragraph> <paragraph num="(2)"> <text>Assigning an expert reviewer for review of an adverse decision;</text> </paragraph> <paragraph num="(3)"> <text>Performing conflicts checks relative to the independent review organization and the expert reviewer assigned to review the adverse decision;</text> </paragraph> <paragraph num="(4)"> <text>Communicating procedural rules, as approved by the Department, and other information regarding appeals to the parties;</text> </paragraph> <paragraph num="(5)"> <text>Rendering a timely final decision in accordance with Regulation .06F of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Conflicts of Interest Standards for Independent Review Organizations and Expert Reviewers."> <paragraph num="A."> <text>An IRO or expert reviewer may not be an affiliate or have a financial, familial or professional relationship with any facility, provider, or organization that has filed a complaint.</text> </paragraph> <paragraph num="B."> <text>Upon request by the Department, the IRO shall provide to the Department information demonstrating compliance with the requirement in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Assignment of an Expert Reviewer."> <paragraph num="A."> <text>The IRO shall ensure that an expert reviewer:</text> <paragraph num="(1)"> <text>Has appropriate clinical expertise in the treatment of the specific medical condition being reviewed and holds a nonrestricted license as a health care provider in the United States; and</text> </paragraph> <paragraph num="(2)"> <text>Has no history of disciplinary investigations, actions, or sanctions, including loss of staff privileges or participation restrictions that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Upon request by the Department, the independent review organization shall provide to the Department information demonstrating compliance with the requirements in §A of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Independent Review."> <paragraph num="A."> <text>A provider shall exhaust an MCO’s provider appeal process before filing a complaint with the IRO.</text> </paragraph> <paragraph num="B."> <text>A provider shall file a complaint with the IRO in the form provided by the IRO not later than 30 calendar days following the date of an MCO’s adverse decision.</text> </paragraph> <paragraph num="C."> <text>A review of an adverse decision shall be based on the case record.</text> </paragraph> <paragraph num="D."> <text>The IRO shall, after reviewing the case record, issue a final decision as to whether the health care services that are the subject of the complaint were medically necessary.</text> </paragraph> <paragraph num="E."> <text>The final decision shall state in writing the factual bases for the decision of the expert reviewer and reference the criteria and standards on which the expert reviewer's decision was based.</text> </paragraph> <paragraph num="F."> <text>Final decisions shall be rendered within 45 days of submission of the case record, unless the time period is extended by the Department.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Payment of Fees and Sanctions."> <paragraph num="A."> <text>In the event that a provider’s complaint is unsuccessful, the provider is responsible for paying to the IRO the case review charge established by the Department.</text> </paragraph> <paragraph num="B."> <text>The case review charge established by the Department shall be based on the contract between the Department and the IRO arrived at through a competitive procurement process.</text> </paragraph> <paragraph num="C."> <text>An MCO that is determined by the IRO to have improperly denied, either in whole or in part, a provider’s claim on medical necessity grounds is subject to the following:</text> <paragraph num="(1)"> <text>Within 60 calendar days of the date of an adverse decision by an IRO, the MCO shall fully reimburse the provider for claims determined to be medically necessary by the IRO, including any interest owed under Health Insurance Article, §15-1005(f), Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Within 60 calendar days of the date of invoice by the IRO, the MCO shall reimburse the IRO the case review charge established by the Department.</text> </paragraph> </paragraph> <paragraph num="D."> <text>In the event that the unsuccessful party does not pay the IRO within 60 calendar days of the date of the invoice, the Department shall impose penalties as follows:</text> <paragraph num="(1)"> <text>First delinquency: 17 percent of the invoice amount;</text> </paragraph> <paragraph num="(2)"> <text>Second delinquency: 35 percent of the invoice amount; and</text> </paragraph> <paragraph num="(3)"> <text>Third delinquency: 50 percent of the invoice amount plus:</text> <paragraph num="(a)"> <text>For providers, suspension from using the independent case review services for 1 year; or</text> </paragraph> <paragraph num="(b)"> <text>For MCOs, any sanction set forth in COMAR 10.67.10.01A(1)—(5), as determined by the Department.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeal."> <paragraph num="A."> <text>As a prerequisite for participating in the IRO complaint adjudication process, a provider waives all other administrative and judicial appeal rights and accepts the IRO’s decision as final and binding.</text> </paragraph> <paragraph num="B."> <text>An MCO that receives an adverse decision from an independent review organization may file an appeal in accordance with COMAR 10.67.10.02.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §§2-104(b) and 15-103(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: April 28, 2014 (41:8 Md. R. 471)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244)</annotation> <annotation type="History" subtype="Administrative History">Chapter transferred from COMAR 10.09.86 effective November 1, 2019 (46:22 Md. R. 977)</annotation> </annotations> </chapter> </subtitle> <subtitle num="68" heading="Community Health Workers"> <chapter num="01" heading="Certification of Community Health Workers"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation” means the approval a community health worker certification training program receives when it has met all the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Accredited community health worker certification training program” means a community health worker certification training program that has been accredited by the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Applicant” means an individual who applies to the Maryland Department of Health to obtain a community health worker certificate.</text> </paragraph> <paragraph num="(4)"> <text>“Certificate” means a certificate issued by the Department to authorize an individual who meets the requirements of this chapter to represent to the public as a certified community health worker in the State.</text> </paragraph> <paragraph num="(5)"> <text>“Certified community health worker (CCHW)” means an individual who has successfully met the requirements stated in this chapter.</text> </paragraph> <paragraph num="(6)"> <text>“Community health worker (CHW)” has the meaning set forth in Health-General Article, §13-3701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Core competencies” means:</text> <paragraph num="(a)"> <text>Advocacy and community capacity building skills;</text> </paragraph> <paragraph num="(b)"> <text>Effective oral and written communication skills;</text> </paragraph> <paragraph num="(c)"> <text>Cultural competency;</text> </paragraph> <paragraph num="(d)"> <text>Understanding of ethics and confidentiality issues;</text> </paragraph> <paragraph num="(e)"> <text>Knowledge of local resources and system navigation;</text> </paragraph> <paragraph num="(f)"> <text>Care coordination support skills;</text> </paragraph> <paragraph num="(g)"> <text>Teaching skills to promote healthy behavior change;</text> </paragraph> <paragraph num="(h)"> <text>Outreach methods and strategies; and</text> </paragraph> <paragraph num="(i)"> <text>Understanding of public health concepts and health literacy.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(9)"> <text>“Professional development activities” means knowledge and skill building opportunities related to the core competencies of community health workers or health principles that may include:</text> <paragraph num="(a)"> <text>Courses;</text> </paragraph> <paragraph num="(b)"> <text>Webinars;</text> </paragraph> <paragraph num="(c)"> <text>Conferences;</text> </paragraph> <paragraph num="(d)"> <text>Workshops;</text> </paragraph> <paragraph num="(e)"> <text>Trainings; or</text> </paragraph> <paragraph num="(f)"> <text>Lectures.</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>“Secretary” means the Secretary of the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application Procedures."> <paragraph num="A."> <text>Qualified Community Health Worker Applicant. A qualified community health worker applicant is an individual who:</text> <paragraph num="(1)"> <text>Has successfully completed a CHW certification training program that is accredited by the Department; or</text> </paragraph> <paragraph num="(2)"> <text>Is eligible to be exempt from the training requirements as set forth in Regulation .03C of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To obtain a community health worker certification, the applicant shall submit to the Department:</text> <paragraph num="(1)"> <text>A completed application on a form provided by the Department;</text> </paragraph> <paragraph num="(2)"> <text>An initial application fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Documentation of training or training exemption requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>An application is not complete until the Department has received all the materials required under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If an incomplete application is submitted to the Department, the Department shall:</text> <paragraph num="(a)"> <text>Notify the applicant within 30 calendar days after receipt of the incomplete application; and</text> </paragraph> <paragraph num="(b)"> <text>Specify the materials required to be submitted to complete the application.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide the required documentation within 120 calendar days of notification, the Department may:</text> <paragraph num="(a)"> <text>Administratively close the application; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the application, pursuant to the requirements set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The Department may not refund a fee if an application is administratively closed or denied.</text> </paragraph> <paragraph num="(5)"> <text>An applicant whose application is administratively closed or denied may reapply and submit with the new application documentation in compliance with the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Applicant Age, Training, and Experience Requirements."> <paragraph num="A."> <text>Age Requirement. An individual seeking community health worker certification shall be 18 years old or older.</text> </paragraph> <paragraph num="B."> <text>Certification by Completion of a CHW Certification Training Program Accredited by the Department. An applicant for community health worker certification shall:</text> <paragraph num="(1)"> <text>Provide documentation of successful completion of an accredited CHW certification training program as set forth in this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Possess a high school diploma or GED equivalent.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Exemption from Training Program Requirements.</text> <paragraph num="(1)"> <text>The Department may exempt an individual occupied as a CHW on October 1, 2018, from the training program requirements set forth in this chapter if the applicant provides documentation of:</text> <paragraph num="(a)"> <text>The completion of a minimum of 2,000 hours of CHW paid or volunteer experience 5 years prior to:</text> <paragraph num="(i)"> <text>October 1, 2018; or</text> </paragraph> <paragraph num="(ii)"> <text>The application date;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A minimum of two letters of validation, on a form that the Department requires, from a current or former CHW employer, supervisor, or agency representative that recommend the individual for certification and validate the minimum of 2,000 hours of required experience; and</text> </paragraph> <paragraph num="(c)"> <text>Proficiency in core competencies to be detailed by the applicant and verified in writing by a CHW employer, supervisor, or agency representative.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The deadline for submission of an application for exemption from the training program requirements under this section is March 31, 2020.</text> </paragraph> <paragraph num="(3)"> <text>An applicant may request an extension to submit an application, not to exceed 60 days, if:</text> <paragraph num="(a)"> <text>The applicant submits documentation of good cause for an extension; and</text> </paragraph> <paragraph num="(b)"> <text>The Department determines that an extension is reasonable under the circumstances.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Action on Application."> <paragraph num="A."> <text>Upon review of a completed application, the Department shall:</text> <paragraph num="(1)"> <text>Approve the issuance of a certificate to the applicant if the applicant meets the requirements specified in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Request additional information to make a determination; or</text> </paragraph> <paragraph num="(3)"> <text>Deny the issuance of a certificate to the applicant.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Approval for Certification and Issuance of Certificate.</text> <paragraph num="(1)"> <text>If the Department approves the issuance of a certificate to an applicant, the Department shall:</text> <paragraph num="(a)"> <text>Send the applicant a written notice that the applicant is qualified for a certificate; and</text> </paragraph> <paragraph num="(b)"> <text>Issue a certificate to the applicant.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The Department shall include on each certificate:</text> <paragraph num="(a)"> <text>The full name of the certificate holder;</text> </paragraph> <paragraph num="(b)"> <text>The dates of issuance and expiration;</text> </paragraph> <paragraph num="(c)"> <text>A serial number; and</text> </paragraph> <paragraph num="(d)"> <text>The signature of the Department representative.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Denial of Issuance of Certificate.</text> <paragraph num="(1)"> <text>The Department may deny the issuance of a certificate if it determines the applicant has:</text> <paragraph num="(a)"> <text>Not met the age, training, or experience requirements as set forth in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Failed to remit a fee; or</text> </paragraph> <paragraph num="(c)"> <text>Failed to complete the application form.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department denies the issuance of a certificate, the Department shall:</text> <paragraph num="(a)"> <text>Send the applicant written notice of the Department’s denial of the issuance of a certificate, including specification of deficiencies; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the right to appeal the denial and to request a formal hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>An applicant who has been denied the issuance of a certificate by the Department may reapply and submit new application documentation in compliance with the requirements of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>Appealing a Decision to Deny Issuance of a Certificate. An applicant may appeal the decision to deny issuance of a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of denial of certification.</text> </paragraph> <paragraph num="(5)"> <text>If an applicant submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Sustain or reverse the decision on the application; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the decision on the application has been sustained or reversed; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>The Department may not refund a fee if the certification is denied.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s denial of the issuance of a certificate. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Certification Representation."> <text>An individual shall be certified by the Department before the individual may represent to the public that the individual is a certified community health worker.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Requirement to Update Contact Information."> <text>An individual certified by the Department shall inform the Department, within a reasonable time period, of any changes to the certificate holder’s name and contact information.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Expiration and Renewal."> <paragraph num="A."> <text>Unless the Department suspends or revokes the certificate, the certificate:</text> <paragraph num="(1)"> <text>Is effective for 2 years from the date issued; and</text> </paragraph> <paragraph num="(2)"> <text>Authorizes the individual to represent to the public that the individual is a certified community health worker.</text> </paragraph> </paragraph> <paragraph num="B."> <text>At least 90 calendar days before the certificate expires, the Department shall send to the certified community health worker, by electronic or first-class mail to the last known electronic or physical address, a renewal notice that states:</text> <paragraph num="(1)"> <text>The date on which the current certificate expires;</text> </paragraph> <paragraph num="(2)"> <text>Any required renewal submission requirements;</text> </paragraph> <paragraph num="(3)"> <text>The date by which the renewal application shall be received by the Department for the renewal to be issued; and</text> </paragraph> <paragraph num="(4)"> <text>The amount of a renewal fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The certificate holder shall notify the Department if a renewal notice is not received within 60 calendar days before the required renewal date.</text> </paragraph> <paragraph num="D."> <text>The Department shall renew the certificate of a certified community health worker who:</text> <paragraph num="(1)"> <text>Is eligible to obtain a certificate;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Department a renewal fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Department:</text> <paragraph num="(a)"> <text>A renewal application on the form required by the Department; and</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory documentation of completion of 20 hours of a broad range of professional development activities that include a written explanation of acquired knowledge and/or skill application of duties on a form that the Department requires.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Renewal applications shall be received 30 calendar days prior to the expiration date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Reinstatement of Certificate Due to Nonrenewal."> <paragraph num="A."> <text>The Department shall reinstate the certificate of a community health worker who has failed to renew the certificate, if the individual:</text> <paragraph num="(1)"> <text>Has not had the certificate suspended or revoked;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Department documentation of:</text> <paragraph num="(a)"> <text>Completion of 20 hours of a broad range of professional development activities; and</text> </paragraph> <paragraph num="(b)"> <text>A written explanation of acquired knowledge and/or skill application of duties within the 2-year period immediately preceding the date of renewal;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Applies to the Department for reinstatement of the certificate before 2 years after the certificate expires;</text> </paragraph> <paragraph num="(4)"> <text>Pays to the Department a renewal fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(5)"> <text>Meets the requirements for certification set forth by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a CHW is not eligible for reinstatement of a certificate under this chapter, the community health worker may be eligible for the issuance of a certificate by meeting the current requirements for obtaining a new certificate under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Suspension or Revocation of a Certificate."> <paragraph num="A."> <text>The Department may suspend or revoke the certificate of a community health worker who no longer meets the requirements established under this chapter.</text> </paragraph> <paragraph num="B."> <text>Subject to the hearing provisions of COMAR 10.01.03, the Department may suspend or revoke a certificate if the individual:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a certificate for a community health worker or for another individual;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a certificate;</text> </paragraph> <paragraph num="(3)"> <text>Otherwise fails to meet substantially the standards for certification adopted under this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Is convicted of or pleads guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(5)"> <text>Performs the duties of a community health worker while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5–101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state, territory, or country for an act that would be grounds for suspension or revocation action under this title;</text> </paragraph> <paragraph num="(7)"> <text>Performs the duties of a certified community health worker with an unauthorized person or supervises or aids an unauthorized person in performing the duties of a certified community health worker;</text> </paragraph> <paragraph num="(8)"> <text>Willfully makes or files a false report or record while performing the duties of a certified community health worker;</text> </paragraph> <paragraph num="(9)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="(10)"> <text>Commits an act of unprofessional conduct in performing the duties of a community health worker;</text> </paragraph> <paragraph num="(11)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the individual is certified and qualified to render because of the individual’s race, sex, creed, color, national origin, marital status, sexual orientation, age, gender identity, or disability; or</text> </paragraph> <paragraph num="(12)"> <text>Fails to maintain on file with the Department a current resident address or employment address or notify the Department when the residency or place of employment changes.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03.</text> </paragraph> <paragraph num="D."> <text>The Department shall send written notice of intent to suspend or revoke a certificate to the individual and identify the specific deficiencies.</text> </paragraph> <paragraph num="E."> <text>Within 30 calendar days after receipt of written notice, the individual may submit to the Department:</text> <paragraph num="(1)"> <text>A written plan by the individual to meet the applicable deficiencies; or</text> </paragraph> <paragraph num="(2)"> <text>A written response setting forth documentation that the individual is meeting and maintaining each of the applicable requirements as set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Based on deficiencies and the individual’s response, if any, the Department may suspend, revoke, or reinstate a certificate.</text> </paragraph> <paragraph num="G."> <text>Appealing the Decision to Suspend or Revoke a Certificate.</text> <paragraph num="(1)"> <text>An individual may appeal the decision to suspend or revoke a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of a certificate.</text> </paragraph> <paragraph num="(2)"> <text>If an individual submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Send individual written notice:</text> <paragraph num="(i)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department may not refund a fee if a certification is suspended or revoked.</text> </paragraph> </paragraph> <paragraph num="H."> <text>An individual may request a hearing within 10 calendar days after receipt of written notice.</text> </paragraph> <paragraph num="I."> <text>When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §13-3705, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 30, 2019 (46:26 Md. R. 1166)</annotation> </annotations> </chapter> <chapter num="02" heading="Community Health Worker Certification Training Programs"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation” means the approval a community health worker certification training program receives when it has met all the requirements of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>“Accredited community health worker certification training program” means a community health worker certification training program that has been accredited by the Maryland Department of Health.</text> </paragraph> <paragraph num="(3)"> <text>“Applicant” means a community health worker training program that applies to the Maryland Department of Health for accreditation.</text> </paragraph> <paragraph num="(4)"> <text>“Community health worker (CHW)” has the meaning set forth in Health-General Article, §13-3701, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Community health worker certification training program” means a training program that has been accredited by the Department.</text> </paragraph> <paragraph num="(6)"> <text>“Department” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(7)"> <text>“Review Committee” means the CHW Training Program Application Review Committee.</text> </paragraph> <paragraph num="(8)"> <text>“Secretary” means the Secretary of the Maryland Department of Health.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Application Procedures."> <paragraph num="A."> <text>Accreditation Requirements.</text> <paragraph num="(1)"> <text>All CHW certification training programs shall be accredited by the Department.</text> </paragraph> <paragraph num="(2)"> <text>The accreditation shall be issued before an organization may offer a CHW certification training program.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To obtain accreditation of a CHW certification training program, an organization shall:</text> <paragraph num="(1)"> <text>Obtain the CHW certification training program requirements and a program application from the Department;</text> </paragraph> <paragraph num="(2)"> <text>Submit to the Department an application; and</text> </paragraph> <paragraph num="(3)"> <text>Pay to the Department a fee set by the Department in regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A CHW certification training program that was in operation on or before October 1, 2018:</text> <paragraph num="(1)"> <text>Will be notified by the Department by certified mail, electronic mail, or MDH website posting of the training program requirements for accreditation set forth in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Shall comply with the accreditation requirements; and</text> </paragraph> <paragraph num="(3)"> <text>Shall complete an application for accreditation as set forth in this chapter by December 31, 2020.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A CHW certification training program that trained individuals from October 1, 2018, through December 31, 2020, will be eligible to apply for accreditation for that time period if the training program:</text> <paragraph num="(1)"> <text>Meets the CHW certified training program requirements as set forth in Regulation .03 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Submits to the Department an application;</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Department a fee set by the Department in regulation;</text> </paragraph> <paragraph num="(4)"> <text>Becomes an accredited training program; and</text> </paragraph> <paragraph num="(5)"> <text>Provides a list of students who successfully completed the training program during the stated time period.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department may provide technical assistance to CHW certification training programs to meet the requirements set forth in this chapter.</text> </paragraph> <paragraph num="F."> <text>Incomplete Applications.</text> <paragraph num="(1)"> <text>An application is not complete until the Department has received all the materials required under this chapter.</text> </paragraph> <paragraph num="(2)"> <text>If an incomplete application is submitted to the Department, the Department shall notify the applicant within 30 calendar days after receipt of the incomplete application of the materials that are required to be submitted to complete the application.</text> </paragraph> <paragraph num="(3)"> <text>If the applicant fails to provide the required documentation within 120 calendar days of notification, the Department may:</text> <paragraph num="(a)"> <text>Administratively close the application; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the application, pursuant to Regulation .04D of this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An applicant whose application is administratively closed or denied may reapply and submit with the new application documentation in compliance with the requirements of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Training Program Requirements."> <paragraph num="A."> <text>A CHW certification training program shall:</text> <paragraph num="(1)"> <text>Provide a minimum of 100 hours of instruction;</text> </paragraph> <paragraph num="(2)"> <text>Verify successful completion of an additional supervised 40-hour practicum by a student;</text> </paragraph> <paragraph num="(3)"> <text>Employ a curriculum framework that incorporates, at a minimum, the following core competencies:</text> <paragraph num="(a)"> <text>Advocacy and community capacity building skills;</text> </paragraph> <paragraph num="(b)"> <text>Effective oral and written communication skills;</text> </paragraph> <paragraph num="(c)"> <text>Cultural competency;</text> </paragraph> <paragraph num="(d)"> <text>Understanding of ethics and confidentiality issues;</text> </paragraph> <paragraph num="(e)"> <text>Knowledge of local resources and system navigation;</text> </paragraph> <paragraph num="(f)"> <text>Care coordination support skills;</text> </paragraph> <paragraph num="(g)"> <text>Teaching skills to promote healthy behavior change;</text> </paragraph> <paragraph num="(h)"> <text>Outreach methods and strategies; and</text> </paragraph> <paragraph num="(i)"> <text>Understanding of public health concepts and health literacy; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Include an objective knowledge assessment.</text> </paragraph> </paragraph> <paragraph num="B."> <text>To complete an accredited CHW certification training program, a student shall successfully meet all requirements of the program.</text> </paragraph> <paragraph num="C."> <text>Each accredited CHW certification training program shall submit to the Department, as requested, information on the program.</text> </paragraph> <paragraph num="D."> <text>Without the Department’s approval, an accredited CHW certification training program may not substantively modify an accredited curriculum in a way that results in the curriculum no longer satisfying the core competency requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Action on Application."> <paragraph num="A."> <text>Application Review. Upon receipt of a completed application, the Department shall:</text> <paragraph num="(1)"> <text>Accept and review applications for accreditation of a CHW certification training program in accordance with a schedule established by the Department and made publicly available;</text> </paragraph> <paragraph num="(2)"> <text>Acknowledge receipt of an application within 10 calendar days after receiving the application;</text> </paragraph> <paragraph num="(3)"> <text>Act on an application within 60 calendar days after the training program has met all the application requirements; and</text> </paragraph> <paragraph num="(4)"> <text>Make a decision regarding application accreditation within 120 calendar days.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Application Review Committee.</text> <paragraph num="(1)"> <text>Training program applications will be reviewed by a Community Health Worker Training Program Application Review Committee consisting of:</text> <paragraph num="(a)"> <text>A community health worker;</text> </paragraph> <paragraph num="(b)"> <text>A State Community Health Worker Advisory Committee member;</text> </paragraph> <paragraph num="(c)"> <text>A health professions educator with expertise in curriculum development;</text> </paragraph> <paragraph num="(d)"> <text>AN MDH CHW certification program staff member; and</text> </paragraph> <paragraph num="(e)"> <text>As deemed necessary by the Department, an MDH program staff member with subject matter expertise in specialty areas.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Individuals will be selected for the Training Program Application Review Committee by the Secretary after review of an application.</text> </paragraph> <paragraph num="(3)"> <text>The Review Committee shall review training program applications to determine whether a training program application meets the requirements set forth in this chapter.</text> </paragraph> <paragraph num="(4)"> <text>The Review Committee shall forward recommendations for accreditation of eligible training programs to the Secretary.</text> </paragraph> <paragraph num="(5)"> <text>The Secretary may approve and direct the Department to accredit a training program if the training program:</text> <paragraph num="(a)"> <text>Satisfies the requirements set forth in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Pays to the Department a fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(c)"> <text>Participates in an on-site visit, if deemed necessary by the Department.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Approval of Accreditation Application. If the Department accredits a training program, the Department shall send the applicant written notice that the program is accredited.</text> </paragraph> <paragraph num="D."> <text>Denial of Accreditation Application.</text> <paragraph num="(1)"> <text>The Department may deny accreditation if it determines that the training program has:</text> <paragraph num="(a)"> <text>Not complied fully with the applicable requirements described in this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Failed to remit a fee; or</text> </paragraph> <paragraph num="(c)"> <text>Failed to complete the application form.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If the Department denies accreditation, the Department shall:</text> <paragraph num="(a)"> <text>Send the applicant written notice of the Department’s denial of accreditation, including specific deficiencies; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the applicant of the right to appeal the denial and to request a formal hearing.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Within 30 calendar days after receipt of the denial, the training program may submit to the Department either:</text> <paragraph num="(a)"> <text>A written plan that sets forth the steps taken by the program to meet the applicable requirements described in this chapter; or</text> </paragraph> <paragraph num="(b)"> <text>A written response setting forth documentation that the program is meeting and maintaining each of the applicable requirements described in this chapter.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Based on the deficiencies and the program’s written response, if any, the Department may approve or deny the application.</text> </paragraph> <paragraph num="(5)"> <text>Appealing a Decision to Deny an Application for Accreditation. A CHW certification training program may appeal the decision to deny an application by submitting the request in writing to the Department within 30 calendar days of the date on the notice of denial of application.</text> </paragraph> <paragraph num="(6)"> <text>If a CHW certification training program submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Provide written notice to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>The Department may not refund a fee if an accreditation is denied.</text> </paragraph> <paragraph num="(8)"> <text>An applicant may request a hearing within 10 calendar days after receipt of written notice of the Department’s denial. After receiving the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Expiration and Renewal."> <paragraph num="A."> <text>Unless the Department suspends or revokes a CHW certification training program accreditation, the accreditation is effective for 3 years from the date issued.</text> </paragraph> <paragraph num="B."> <text>At least 90 calendar days before the accreditation expires, the Department shall send to the accredited CHW certification training program by electronic or first-class mail to the last known electronic or physical address a renewal notice that states:</text> <paragraph num="(1)"> <text>The date on which the current accreditation expires;</text> </paragraph> <paragraph num="(2)"> <text>Any required renewal submission requirements;</text> </paragraph> <paragraph num="(3)"> <text>The date by which the renewal application shall be received by the Department for the renewal to be issued; and</text> </paragraph> <paragraph num="(4)"> <text>The amount of a renewal fee.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The accredited CHW certification training program shall notify the Department if a renewal notice is not received within 60 calendar days of the renewal date.</text> </paragraph> <paragraph num="D."> <text>The Department shall renew the accredited CHW certification training program that:</text> <paragraph num="(1)"> <text>Is eligible to obtain accreditation;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Department a renewal fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Department a renewal application on a form that the Department requires.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Renewal applications received less than 30 calendar days before the expiration date may not be processed before the expiration date.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Reinstatement of Accreditation Due to Nonrenewal."> <paragraph num="A."> <text>The Department shall reinstate the accreditation of a CHW certification training program that has failed to renew their accreditation, if the program:</text> <paragraph num="(1)"> <text>Has not had the accreditation suspended or revoked;</text> </paragraph> <paragraph num="(2)"> <text>Applies to the Department for reinstatement of the accreditation before 2 years after the accreditation expires;</text> </paragraph> <paragraph num="(3)"> <text>Pays to the Department a renewal fee set by the Department in regulation; and</text> </paragraph> <paragraph num="(4)"> <text>Meets the requirements for accreditation set forth by the Department.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a CHW certification training program is not eligible for reinstatement of accreditation under this chapter, the program may be eligible for accreditation by meeting the current requirements for obtaining a new accreditation under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Suspension or Revocation of Accreditation of a Training Program."> <paragraph num="A."> <text>The Department may suspend or revoke the accreditation from any program which:</text> <paragraph num="(1)"> <text>No longer meets the requirements established under this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Fails to submit in a timely manner:</text> <paragraph num="(a)"> <text>Any information requested by the Department; or</text> </paragraph> <paragraph num="(b)"> <text>Notification of curriculum modification;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Falsifies training program information; or</text> </paragraph> <paragraph num="(4)"> <text>Fails to comply with applicable laws or regulations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03.</text> </paragraph> <paragraph num="C."> <text>The Department shall send written notice of the suspension or revocation of accreditation to the training program and identify the specific deficiencies.</text> </paragraph> <paragraph num="D."> <text>Within 30 calendar days after receipt of written notice, the CHW certification training program may submit to the Department:</text> <paragraph num="(1)"> <text>A written plan by the CHW certification training program to meet the applicable deficiencies; or</text> </paragraph> <paragraph num="(2)"> <text>A written response setting forth documentation that the program is meeting and maintaining each of the applicable requirements described in this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Based on deficiencies and the program’s response, if any, the Department may suspend, revoke or reinstate accreditation.</text> </paragraph> <paragraph num="F."> <text>Appealing a Decision to Suspend or Revoke Accreditation.</text> <paragraph num="(1)"> <text>A CHW certification training program may appeal the decision to suspend or revoke the accreditation by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of accreditation.</text> </paragraph> <paragraph num="(2)"> <text>If a CHW certification training program submits an appeal, the Department shall within 60 calendar days:</text> <paragraph num="(a)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Respond in writing to the applicant:</text> <paragraph num="(i)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department may not refund a fee if an accreditation is suspended or revoked.</text> </paragraph> </paragraph> <paragraph num="G."> <text>An applicant may request a hearing within 10 calendar days after receipt of written notice.</text> </paragraph> <paragraph num="H."> <text>After receiving the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Health-General Article, §13-3705, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 30, 2019 (46:26 Md. R. 1166)</annotation> </annotations> </chapter> </subtitle> <subtitle num="69" heading="Board of Nursing—Licensed Certified Midwives"> <chapter num="01" heading="Licensure of Licensed Certified Midwives"> <regulation prefix="Regulation" num=".01" heading="Exceptions."> <text>This chapter does not apply to an individual who:</text> <paragraph num="A."> <text>Assists at a birth in an emergency;</text> </paragraph> <paragraph num="B."> <text>Is licensed as a health care practitioner in accordance with the Health Occupations Article, Annotated Code of Maryland whose scope of practice allows the individual to practice certified midwifery; or</text> </paragraph> <paragraph num="C."> <text>Is a student practicing certified midwifery while engaged in an approved clinical midwifery education experience under the supervision of an individual licensed by the Board as a licensed certified midwife or a licensed nurse certified as a nurse midwife.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation Commission for Midwifery (ACME)” means the accrediting agency for midwifery education programs and institutions, or a successor organization, which is approved by the United States Department of Education.</text> </paragraph> <paragraph num="(2)"> <text>“American College of Nurse Midwives (ACNM)” means the national professional association, or a successor organization, that represents advanced practice midwives, including certified nurse-midwives and certified midwives in the United States</text> </paragraph> <paragraph num="(3)"> <text>“American Midwifery Certification Board (AMCB)” means the national certifying body for candidates in nurse-midwifery and midwifery, or a successor organization, which is approved by the National Commission for Certifying Agencies.</text> </paragraph> <paragraph num="(4)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(5)"> <text>“Central Repository” has the meaning stated in Health Occupations Article, §8-303(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Clinical practice guidelines” means written standards using guidelines established by:</text> <paragraph num="(a)"> <text>The ACNM in Standards for the Practice of Midwifery, as amended or supplemented; or</text> </paragraph> <paragraph num="(b)"> <text>Any other national certifying body recognized by the Board.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Licensed certified midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery.</text> </paragraph> <paragraph num="(8)"> <text>“Newborn” means an infant in the first 28 days after birth.</text> </paragraph> <paragraph num="(9)"> <text>“Practice certified midwifery” has the meaning stated in Health Occupations Article, §8-6D-01(h), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Physician” means an individual licensed to practice medicine in the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Qualifications for Applicants for Initial Licensure."> <text>An applicant for initial licensure as a certified midwife shall:</text> <paragraph num="A."> <text>Be of good moral character;</text> </paragraph> <paragraph num="B."> <text>Submit to a criminal history records check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="C."> <text>Hold a current, valid national certification as a certified midwife from the AMCB;</text> </paragraph> <paragraph num="D."> <text>Have graduated from a graduate-level midwifery education program accredited by the ACME; and</text> </paragraph> <paragraph num="E."> <text>Have passed the AMCB certification examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for Application for Initial Licensure."> <paragraph num="A."> <text>An applicant for initial licensure as a certified midwife shall submit to the Board:</text> <paragraph num="(1)"> <text>A completed application on the form that the Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Written, verified evidence that the applicant has met the requirements of Regulation .03C—E of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Written, verified evidence that the applicant has submitted to a criminal history records check as required by Regulation .03B of this chapter by submitting:</text> <paragraph num="(a)"> <text>Two sets of fingerprints, as required by the Central Repository and the Federal Bureau of Investigation; and</text> </paragraph> <paragraph num="(b)"> <text>All fees required by the Central Repository and the FBI;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board:</text> <paragraph num="(a)"> <text>In accordance with Health Occupations Article, §8-303, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>In an answer to a question on the Board’s application form; or</text> </paragraph> <paragraph num="(c)"> <text>From any other source;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) of this regulation is incomplete or insufficient; and</text> </paragraph> <paragraph num="(6)"> <text>A fee for initial licensure as specified under Regulation .13 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to:</text> <paragraph num="(1)"> <text>Complete the application; and</text> </paragraph> <paragraph num="(2)"> <text>Provide all information and documents required in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board in §A of this regulation within 12 months from the date the application is received by the Board, then the application:</text> <paragraph num="(1)"> <text>Shall be considered abandoned; and</text> </paragraph> <paragraph num="(2)"> <text>May be destroyed.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Once an application is deemed abandoned under §C of this regulation, an individual seeking licensure shall:</text> <paragraph num="(1)"> <text>Submit a new application;</text> </paragraph> <paragraph num="(2)"> <text>Meet all of the requirements for licensure; and</text> </paragraph> <paragraph num="(3)"> <text>Pay the required fees in accordance with Regulation .13 of this chapter in effect at the time of re-application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Practice Before Certification."> <paragraph num="A."> <text>An individual who has graduated from a graduate level accredited program for midwifery education program approved by the ACME and who has taken the AMCB national certification examination but is waiting for results may practice as a certified midwife graduate before certification if the:</text> <paragraph num="(1)"> <text>Practice is under the supervision of a licensed certified midwife or certified nurse midwife who shall be physically present at the location of service and available to the certified midwife graduate;</text> </paragraph> <paragraph num="(2)"> <text>Supervising midwife and certified midwife graduate execute a written supervision agreement on the form required by the Board; and</text> </paragraph> <paragraph num="(3)"> <text>Certified midwife graduate files with the Board a copy of the:</text> <paragraph num="(a)"> <text>Admission slip to the Board-approved certification examination; and</text> </paragraph> <paragraph num="(b)"> <text>Signed supervision agreement.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A certified midwife graduate who has entered into a supervision agreement under this regulation shall immediately notify the Board and the supervising midwife of the results of the AMCB certification examination.</text> </paragraph> <paragraph num="C."> <text>A certified midwife graduate may not continue to practice under a supervision agreement under this regulation for more than 1 year from the filing of all documents required under §A(3) of this regulation, or after the denial of AMCB certification, whichever occurs first.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Term and Renewal of License."> <paragraph num="A."> <text>A license issued under this regulation authorizes the licensee to practice licensed certified midwifery while the license is active.</text> </paragraph> <paragraph num="B."> <text>Unless renewed, a license expires on October 28 of every even-numbered year, except that an initial license shall not expire within 180 days of the date of issuance.</text> </paragraph> <paragraph num="C."> <text>Before a license expires, the licensed certified midwife may renew the license for an additional 2-year term if the licensed certified midwife:</text> <paragraph num="(1)"> <text>Is otherwise entitled to be licensed;</text> </paragraph> <paragraph num="(2)"> <text>Pays to the Board the renewal fee specified in Regulation .13 of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Submits to the Board:</text> <paragraph num="(a)"> <text>A renewal application on the form that the Board requires;</text> </paragraph> <paragraph num="(b)"> <text>Satisfactory evidence of current national certification as a certified midwife by AMCB; and</text> </paragraph> <paragraph num="(c)"> <text>If required to submit to a criminal history records check in accordance with § C of this regulation, evidence of submission to a criminal history records check as required by the Board.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed certified midwife shall submit to a criminal history records check in order to renew a license in accordance with the following schedule:</text> <paragraph num="(1)"> <text>In 2025—all applicants with an August or September birth month;</text> </paragraph> <paragraph num="(2)"> <text>In 2026—all applicants with a September or October birth month;</text> </paragraph> <paragraph num="(3)"> <text>In 2027—all applicants with an October or November birth month;</text> </paragraph> <paragraph num="(4)"> <text>In 2028— all applicants with a November or December birth month;</text> </paragraph> <paragraph num="(5)"> <text>In 2029—all applicants with a December or January birth month;</text> </paragraph> <paragraph num="(6)"> <text>In 2030—all applicants with a January or February birth month;</text> </paragraph> <paragraph num="(7)"> <text>In 2031—all applicants with a February or March birth month;</text> </paragraph> <paragraph num="(8)"> <text>In 2032—all applicants with a March or April birth month;</text> </paragraph> <paragraph num="(9)"> <text>In 2033—all applicants with an April or May birth month;</text> </paragraph> <paragraph num="(10)"> <text>In 2034—all applicants with a May or June birth month; and</text> </paragraph> <paragraph num="(11)"> <text>In 2035—all applicants with a June or July birth month.</text> </paragraph> <paragraph num="(12)"> <text>In 2036—all applicants with a July or August birth month;</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Board may grant a 30-day extension beyond a license’s expiration date so that the license may be renewed before it expires.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Change in Name or Address."> <text>A licensed certified midwife shall provide written notice to the Board, on the form required by the Board, within 60 days of a change of:</text> <paragraph num="A."> <text>Name, along with legal documentation of the change; or</text> </paragraph> <paragraph num="B."> <text>Address.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Required Documentation."> <paragraph num="A."> <text>A licensed certified midwife who provides clinical midwifery services across the reproductive lifespan in accordance with this subtitle shall:</text> <paragraph num="(1)"> <text>Maintain a health record for each client;</text> </paragraph> <paragraph num="(2)"> <text>In the case of a transfer of care to another provider or a facility, transfer the client’s health records with the client; and</text> </paragraph> <paragraph num="(3)"> <text>Comply with applicable State laws and regulations governing the creation and maintenance of health care records.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed certified midwife who provides clinical midwifery services shall have available at all times for examination by the Board, written clinical practice guidelines that cover all aspects of care, practice, and quality assurance, including but not limited to:</text> <paragraph num="(1)"> <text>A plan for emergency consultation;</text> </paragraph> <paragraph num="(2)"> <text>A plan for transfer of care; and</text> </paragraph> <paragraph num="(3)"> <text>A plan for admission of the client or newborn to a hospital within the client’s geographic area.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Scope of Practice."> <paragraph num="A."> <text>A licensed certified midwife may perform the following functions:</text> <paragraph num="(1)"> <text>Independent management of clients appropriate to the skill and educational preparation of the licensed certified midwife and the licensed certified midwife's clinical practice guidelines;</text> </paragraph> <paragraph num="(2)"> <text>Consultation or collaboration with a physician or other health care provider as needed; and</text> </paragraph> <paragraph num="(3)"> <text>Referral of clients with complications beyond the scope of practice of the licensed certified midwife to another licensed health care practitioner, including a licensed physician.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed certified midwife shall keep a record of all cases attended.</text> </paragraph> <paragraph num="C."> <text>A licensed certified midwife has the right and obligation to refuse to perform any delegated medical act, oral or written, if, in the licensed certified midwife’s judgment, it is unsafe or an invalidly prescribed medical act or beyond the competence of the licensed certified midwife, in which case the licensed certified midwife shall immediately notify the delegating physician.</text> </paragraph> <paragraph num="D."> <text>Subject to the hearing provisions of COMAR 10.01.03, the Department may suspend or revoke a certificate if the individual:</text> <paragraph num="(1)"> <text>Fraudulently or deceptively obtains or attempts to obtain a certificate for a community health worker or for another individual;</text> </paragraph> <paragraph num="(2)"> <text>Fraudulently or deceptively uses a certificate;</text> </paragraph> <paragraph num="(3)"> <text>Otherwise fails to meet substantially the standards for certification adopted under this chapter;</text> </paragraph> <paragraph num="(4)"> <text>Is convicted of or pleads guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </paragraph> <paragraph num="(5)"> <text>Performs the duties of a community health worker while:</text> <paragraph num="(a)"> <text>Under the influence of alcohol; or</text> </paragraph> <paragraph num="(b)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5–101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Is disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state, territory, or country for an act that would be grounds for suspension or revocation action under this title;</text> </paragraph> <paragraph num="(7)"> <text>Performs the duties of a certified community health worker with an unauthorized person or supervises or aids an unauthorized person in performing the duties of a certified community health worker;</text> </paragraph> <paragraph num="(8)"> <text>Willfully makes or files a false report or record while performing the duties of a certified community health worker;</text> </paragraph> <paragraph num="(9)"> <text>Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report;</text> </paragraph> <paragraph num="(10)"> <text>Commits an act of unprofessional conduct in performing the duties of a community health worker;</text> </paragraph> <paragraph num="(11)"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the individual is certified and qualified to render because of the individual’s race, sex, creed, color, national origin, marital status, sexual orientation, age, gender identity, or disability; or</text> </paragraph> <paragraph num="(12)"> <text>Fails to maintain on file with the Department a current resident address or employment address or notify the Department when the residency or place of employment changes.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03.</text> </paragraph> <paragraph num="F."> <text>The Department shall send written notice of intent to suspend or revoke a certificate to the individual and identify the specific deficiencies.</text> </paragraph> <paragraph num="G."> <text>Within 30 calendar days after receipt of written notice, the individual may submit to the Department:</text> <paragraph num="(1)"> <text>A written plan by the individual to meet the applicable deficiencies; or</text> </paragraph> <paragraph num="(2)"> <text>A written response setting forth documentation that the individual is meeting and maintaining each of the applicable requirements as set forth in this chapter.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Based on deficiencies and the individual’s response, if any, the Department may suspend, revoke, or reinstate a certificate.</text> </paragraph> <paragraph num="I."> <text>Appealing the Decision to Suspend or Revoke a Certificate.</text> <paragraph num="(1)"> <text>An individual may appeal the decision to suspend or revoke a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of a certificate.</text> </paragraph> <paragraph num="(2)"> <text>If an individual submits an appeal, the Department, within 60 calendar days, shall:</text> <paragraph num="(a)"> <text>Grant or deny the appeal; and</text> </paragraph> <paragraph num="(b)"> <text>Send individual written notice:</text> <paragraph num="(i)"> <text>Indicating whether the appeal has been granted or denied; and</text> </paragraph> <paragraph num="(ii)"> <text>Providing an explanation of the decision.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The Department may not refund a fee if a certification is suspended or revoked.</text> </paragraph> </paragraph> <paragraph num="J."> <text>An individual may request a hearing within 10 calendar days after receipt of written notice.</text> </paragraph> <paragraph num="K."> <text>When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Compliance."> <text>The certified midwife shall develop and comply with clinical practice guidelines as defined in Regulation .01B of this chapter.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Prescribing and Dispensing of Substances by a Licensed Certified Midwife."> <paragraph num="A."> <text>Pursuant to Health Occupations Article, §8-6D-01, Annotated Code of Maryland, a licensed certified midwife may:</text> <paragraph num="(1)"> <text>Prescribe substances commonly used in the practice of midwifery; and</text> </paragraph> <paragraph num="(2)"> <text>Prescribe controlled dangerous substances on Schedules II-V under Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland, commonly used in the practice of midwifery; and</text> </paragraph> <paragraph num="(3)"> <text>Dispense substances prescribed in accordance with §A(1)—(2)of this regulation in the course of treating a client at a:</text> <paragraph num="(a)"> <text>Nonprofit medical facility or clinic;</text> </paragraph> <paragraph num="(b)"> <text>Health center operating on the campus of an institution of higher education;</text> </paragraph> <paragraph num="(c)"> <text>Public health facility;</text> </paragraph> <paragraph num="(d)"> <text>Medical facility under contract with a State or local health department; or</text> </paragraph> <paragraph num="(e)"> <text>Facility funded with public funds.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed certified midwife who personally prepares and dispenses a drug in the course of treating a client as authorized under §A(3) of this regulation shall:</text> <paragraph num="(1)"> <text>Comply with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Record the dispensing of the prescription drug on the client's chart;</text> </paragraph> <paragraph num="(3)"> <text>Allow the Office of Controlled Substances Administration to enter and inspect the licensed certified midwife's office at all reasonable hours in accordance with Health Occupations Article, §8-508, Annotated Code of Maryland ; and</text> </paragraph> <paragraph num="(4)"> <text>Except for starter dosages or samples dispensed without charge:</text> <paragraph num="(a)"> <text>Provide the client with a written prescription;</text> </paragraph> <paragraph num="(b)"> <text>Maintain prescription files; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain a separate file for Schedule II prescriptions for a period of at least 7 years.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>A licensed certified midwife may personally prepare and dispense a starter dosage of any drug the licensed certified midwife is authorized to prescribe to a client if:</text> <paragraph num="(a)"> <text>The starter dosage complies with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(b)"> <text>No charge is made for the starter dosage; and</text> </paragraph> <paragraph num="(c)"> <text>The licensed certified midwife enters an appropriate record in the client’s medical record.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Unlawful Practices."> <text>Pursuant to Health Occupations Article, Title 8, Subtitle 6D, Annotated Code of Maryland, an individual may not:</text> <paragraph num="A."> <text>Practice licensed certified midwifery unless licensed under this subtitle or otherwise permitted by law to engage in those activities;</text> </paragraph> <paragraph num="B."> <text>Use the title “certified midwife” or the abbreviation “CM” unless licensed by the Board with the intent to represent that the individual practices licensed certified midwifery in the State;</text> </paragraph> <paragraph num="C."> <text>Represent to the public by title, description of service, method, procedure, or otherwise that the individual is authorized to practice licensed certified midwifery in this State unless licensed under this subtitle; or</text> </paragraph> <paragraph num="D."> <text>Advertise in a manner that is unreasonable, misleading, or fraudulent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Licensure Fees."> <paragraph num="A."> <text>The fees listed in this regulation are nonrefundable.</text> </paragraph> <paragraph num="B."> <text>The fees are as follows:</text> <paragraph num="(1)"> <text>Initial application fee—$150;</text> </paragraph> <paragraph num="(2)"> <text>Biennial renewal fee—$120;</text> </paragraph> <paragraph num="(3)"> <text>Biennial reinstatement fee—$70;</text> </paragraph> <paragraph num="(4)"> <text>Verification of licensure fee—$45; and</text> </paragraph> <paragraph num="(5)"> <text>Returned check fee—$30.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Health Care Practitioner User Fee.</text> <paragraph num="(1)"> <text>In addition to a license fee, each licensed certified midwife shall pay a non-refundable health care practitioner user fee assessed by the Maryland Health Care Commission in accordance with Health-General Article, §19-111(b)(4), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>The health care practitioner user fee shall be:</text> <paragraph num="(a)"> <text>In addition to the licensing fee paid to the Board; and</text> </paragraph> <paragraph num="(b)"> <text>Collected with the application for an initial or renewal license.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The amount of the assessed health care practitioner user fee shall be double the amount of the annual health care practitioner user fee for biennial licensure.</text> </paragraph> <paragraph num="(4)"> <text>The Board shall:</text> <paragraph num="(a)"> <text>Account for the health care practitioner user fees; and</text> </paragraph> <paragraph num="(b)"> <text>Transfer the health care practitioner user fees to the Maryland Health Care Commission on a quarterly basis.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 22, 2026 (52:17 Md. R. 875)</annotation> </annotations> </chapter> <chapter num="02" heading="Delegation of Technical Acts by a Licensed Certified Midwife"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter governs the delegation of other technical tasks by a licensed certified midwife to an assistant not otherwise authorized under Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>This chapter may not be construed:</text> <paragraph num="(1)"> <text>As establishing the licensure, certification, or registration of assistants by the Board;</text> </paragraph> <paragraph num="(2)"> <text>To apply to an individual who is licensed, certified, or registered by a health occupations regulatory board, or health occupation students, acting pursuant to Health Occupations Article, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>To mean that this chapter overrides, or is to be used in lieu of, more stringent regulations, policies, and procedures established by State licensure or certification requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Assistant” means an individual:</text> <paragraph num="(a)"> <text>To whom only routine technical tasks are delegated by a licensed certified midwife;</text> </paragraph> <paragraph num="(b)"> <text>Who is trained; and</text> </paragraph> <paragraph num="(c)"> <text>Who is not licensed, certified, registered, or otherwise authorized by law by the Board, or any other State health occupations board, to practice any health occupation in the State.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Asynchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001(b), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Board” means the Maryland Board of Nursing.</text> </paragraph> <paragraph num="(4)"> <text>“Delegating Licensed Certified Midwife (LCM)” means a licensed certified midwife who directs an assistant to perform technical tasks.</text> </paragraph> <paragraph num="(5)"> <text>“Direct supervision” means oversight exercised by a delegating licensed certified midwife who is:</text> <paragraph num="(a)"> <text>Personally treating the client; and</text> </paragraph> <paragraph num="(b)"> <text>In the physical presence of the client and the assistant.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Licensed Certified Midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery in accordance with COMAR 10.69.01.</text> </paragraph> <paragraph num="(7)"> <text>Mechanical Act.</text> <paragraph num="(a)"> <text>“Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion.</text> </paragraph> <paragraph num="(b)"> <text>“Mechanical act” does not include:</text> <paragraph num="(i)"> <text>Selecting a drug;</text> </paragraph> <paragraph num="(ii)"> <text>Labeling;</text> </paragraph> <paragraph num="(iii)"> <text>Measuring or calculating dosages;</text> </paragraph> <paragraph num="(iv)"> <text>Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug;</text> </paragraph> <paragraph num="(v)"> <text>Substituting one dosage form of a drug for another;</text> </paragraph> <paragraph num="(vi)"> <text>Altering the route of administration; or</text> </paragraph> <paragraph num="(vii)"> <text>Counseling client.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(8)"> <text>“On-site supervision” means oversight exercised by a delegating licensed certified midwife who is:</text> <paragraph num="(a)"> <text>Present at the same site as the assistant and the client; and</text> </paragraph> <paragraph num="(b)"> <text>Able to be immediately available in person during the assistant’s performance of a delegated act; or</text> </paragraph> <paragraph num="(c)"> <text>In the context of a synchronous telehealth interaction, able to be immediately available via secure telecommunications technology to the telehealth visit during the assistant’s performance of a delegated act; or</text> </paragraph> <paragraph num="(d)"> <text>In the context of an asynchronous telehealth interaction, is able to review the assistant’s work and interact with the assistant before communication with the client.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>“Site” means any facility or location, including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health services.</text> </paragraph> <paragraph num="(10)"> <text>“Synchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001(d), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Technical task” means a routine clinical act or task that does not require clinical or midwifery judgment and is performed with supervision as specified within this chapter.</text> </paragraph> <paragraph num="(12)"> <text>“Trained” means possessing the knowledge, skills, and abilities, as determined by the delegating licensed certified midwife, to perform delegated technical tasks.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standards for Delegation."> <paragraph num="A."> <text>A licensed certified midwife who delegates shall:</text> <paragraph num="(1)"> <text>Assess the risk to the client and the outcome of the delegated acts;</text> </paragraph> <paragraph num="(2)"> <text>Delegate only those technical tasks that are customary to the practice of a licensed certified midwife;</text> </paragraph> <paragraph num="(3)"> <text>Delegate only those technical tasks for which the assistant has been trained;</text> </paragraph> <paragraph num="(4)"> <text>Be responsible for the acts of the assistant;</text> </paragraph> <paragraph num="(5)"> <text>Supervise the assistant in accordance with this chapter; and</text> </paragraph> <paragraph num="(6)"> <text>If dispensing prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland, perform a final check of the prescription medication before it is provided to the client.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The responsibility for the delegated act cannot be transferred from the delegating licensed certified midwife to another licensed certified midwife, or to another licensed health care provider that is authorized to delegate clinical and technical tasks, without:</text> <paragraph num="(1)"> <text>The expressed consent of the other licensed certified midwife or licensed health care provider; and</text> </paragraph> <paragraph num="(2)"> <text>Informing the assistant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Scope of Delegation to an Assistant."> <paragraph num="A."> <text>A licensed certified midwife may not delegate technical tasks to an assistant which shall, by law or regulation, be performed only by an individual that is required to be licensed, certified, registered, or otherwise recognized pursuant to any State laws.</text> </paragraph> <paragraph num="B."> <text>A licensed certified midwife may delegate technical tasks, consistent with the approved policies and procedures of the site, in the following categories:</text> <paragraph num="(1)"> <text>Surgical technical tasks that the delegating licensed certified midwife directly orders while present and personally performing the surgery in the same surgical field; and</text> </paragraph> <paragraph num="(2)"> <text>Nonsurgical technical tasks while the assistant is under the delegating licensed certified midwife’s direct supervision or on-site supervision.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except as provided in §§B(1) and D of this regulation, a licensed certified midwife shall provide a minimum of on-site supervision when delegating technical tasks to an assistant, including, but not limited to, the following:</text> <paragraph num="(1)"> <text>Client preparation for physical examination;</text> </paragraph> <paragraph num="(2)"> <text>Client history interview;</text> </paragraph> <paragraph num="(3)"> <text>Collecting and processing specimens, such as performing phlebotomy, inoculating culture media, pregnancy tests; dipstick and microscopic urinalysis, and microbiology including rapid streptococcal testing and throat cultures;</text> </paragraph> <paragraph num="(4)"> <text>Preparing and performing laboratory tests under State and Clinical Laboratory Improvement Amendments regulations;</text> </paragraph> <paragraph num="(5)"> <text>Clinical tests;</text> </paragraph> <paragraph num="(6)"> <text>Transmitting prescriptions to a pharmacy;</text> </paragraph> <paragraph num="(7)"> <text>Preparing and administering oral drugs;</text> </paragraph> <paragraph num="(8)"> <text>Establishing a peripheral intravenous line; and</text> </paragraph> <paragraph num="(9)"> <text>Preparing and administering injections including small amounts of local anesthetics if provided either:</text> <paragraph num="(a)"> <text>Intradermal;</text> </paragraph> <paragraph num="(b)"> <text>Subcutaneous; or</text> </paragraph> <paragraph num="(c)"> <text>Intramuscular in the deltoid, gluteal, or vastus lateralis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>When delegating injecting intravenous drugs or contrast materials to an assistant, a licensed certified midwife shall provide direct supervision.</text> </paragraph> <paragraph num="E."> <text>A licensed certified midwife who is dispensing prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland may delegate only mechanical acts involved in dispensing a drug.</text> </paragraph> <paragraph num="F."> <text>A licensed certified midwife may not delegate to an assistant any act that requires the exercise of clinical judgment by a licensed certified midwife, including, but not limited to:</text> <paragraph num="(1)"> <text>Conducting physical examinations;</text> </paragraph> <paragraph num="(2)"> <text>Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics;</text> </paragraph> <paragraph num="(3)"> <text>Initiating independently any form of treatment, except for cardiopulmonary resuscitation, or other forms of emergency treatment authorized to be performed by non-clinicians under State law;</text> </paragraph> <paragraph num="(4)"> <text>Establishing a diagnosis or giving clinical advice; and</text> </paragraph> <paragraph num="(5)"> <text>Providing physical therapy.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Prohibited Conduct and Penalties."> <paragraph num="A."> <text>An assistant acting beyond the scope of this chapter may be:</text> <paragraph num="(1)"> <text>Considered to be engaged in the unlicensed practice of licensed certified midwifery or any other health occupation regulated by the State; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to all applicable fines and penalties in accordance with Health Occupations Article, §§8-701 et seq., Annotated Code of Maryland and applicable regulations, or any other applicable provision of Health Occupations Article, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A delegating licensed certified midwife, through either act or omission, facilitation, or otherwise enabling or forcing an assistant to practice beyond the scope of this chapter, may be subject to discipline as set forth in Health Occupations Article, §8-6D-10, Annotated Code of Maryland.</text> </paragraph> <paragraph num="C."> <text>A delegating licensed certified midwife may not:</text> <paragraph num="(1)"> <text>Require an assistant to perform a delegated technical task; or</text> </paragraph> <paragraph num="(2)"> <text>Permit an assistant to delegate any act to another individual.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Enforcement."> <text>The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland, and this chapter, and it may refer any complaint or investigation to any other appropriate licensing or regulatory authority in accordance with applicable laws and regulations.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 22, 2026 (52:17 Md. R. 875)</annotation> </annotations> </chapter> <chapter num="03" heading="Code of Ethics"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>Abandonment.</text> <paragraph num="(a)"> <text>“Abandonment” means failure to provide or make reasonable arrangements for the continuation of care for a client in need of immediate care or failure to provide reasonable notice to a facility or practice under circumstances that seriously impair the delivery of clinical care to clients.</text> </paragraph> <paragraph num="(b)"> <text>“Abandonment” does not include the declining by a licensed certified midwife of employer-stipulated mandatory overtime.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Board” means the Board of Nursing.</text> </paragraph> <paragraph num="(3)"> <text>“Client” means a patient, resident, or recipient of care.</text> </paragraph> <paragraph num="(4)"> <text>“Electronic devices” means, but is not limited to, any of the following:</text> <paragraph num="(a)"> <text>Telephones with recording and picture-taking ability;</text> </paragraph> <paragraph num="(b)"> <text>Digital cameras or any other device that can record pictures and data;</text> </paragraph> <paragraph num="(c)"> <text>Facsimile machines, photocopiers, and scanners for copying; and</text> </paragraph> <paragraph num="(d)"> <text>Recording devices.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Licensed certified midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery in accordance with COMAR 10.69.01.</text> </paragraph> <paragraph num="(6)"> <text>Social Media.</text> <paragraph num="(a)"> <text>“Social media” means any form of electronic communication.</text> </paragraph> <paragraph num="(b)"> <text>“Social media” includes but is not limited to communication by use of websites or other electronic applications for social networking, commentary, and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Ethical Responsibilities."> <paragraph num="A."> <text>A licensed certified midwife shall:</text> <paragraph num="(1)"> <text>Provide services with respect for human dignity and the uniqueness of a client unrestricted by consideration of social or economic status, religious affiliation, personal attributes, race, sexual orientation, gender identity, or the nature of health problems;</text> </paragraph> <paragraph num="(2)"> <text>Safeguard a client's right to privacy by maintaining confidentiality of information;</text> </paragraph> <paragraph num="(3)"> <text>Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any person;</text> </paragraph> <paragraph num="(4)"> <text>Promptly report a breach of confidentiality or privacy;</text> </paragraph> <paragraph num="(5)"> <text>Assume responsibility and accountability for individual clinical judgments and actions;</text> </paragraph> <paragraph num="(6)"> <text>Maintain competence in licensed certified midwifery;</text> </paragraph> <paragraph num="(7)"> <text>Exercise informed judgment and use individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and when delegating; and</text> </paragraph> <paragraph num="(8)"> <text>Inform the Board regarding unethical conduct by another licensed certified midwife.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed certified midwife may not, when acting in the capacity or identity of a licensed certified midwife:</text> <paragraph num="(1)"> <text>Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation;</text> </paragraph> <paragraph num="(2)"> <text>Engage or participate in an action that violates or diminishes the civil or legal rights of a client;</text> </paragraph> <paragraph num="(3)"> <text>Perform new techniques and procedures without adequate education and practice;</text> </paragraph> <paragraph num="(4)"> <text>Assume duties and responsibilities in the practice of licensed certified midwifery without adequate preparation or without maintaining competency;</text> </paragraph> <paragraph num="(5)"> <text>Practice clinically if unfit to perform procedures or make decisions because of physical or mental impairment, including, but not limited to, the effects of prescription drugs;</text> </paragraph> <paragraph num="(6)"> <text>If engaged in research, coerce or pressure a subject to participate or continue to participate in the research; or</text> </paragraph> <paragraph num="(7)"> <text>Abandon a client.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A licensed certified midwife may not engage in behavior that dishonors the profession whether or not they are acting in the capacity or identity of a licensed certified midwife, including, but not limited to:</text> <paragraph num="(1)"> <text>Verbal abuse, including use of racial or ethnic slurs, directed toward a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(2)"> <text>Physically abusing, threatening, or intimidating a coworker, employer, Board staff member, client, or client’s family member;</text> </paragraph> <paragraph num="(3)"> <text>Deceiving, defrauding, or stealing from a coworker, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(4)"> <text>Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication;</text> </paragraph> <paragraph num="(5)"> <text>Knowingly employ another person to practice, engage in, or attempt to practice, or engage in an occupation or profession licensed by the Board if the employee is not licensed to do so in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(6)"> <text>Performing acts beyond the authorized scope of the level of midwifery practice for which the individual is licensed;</text> </paragraph> <paragraph num="(7)"> <text>Obtaining or copying any part of a client’s health record for purposes other than:</text> <paragraph num="(a)"> <text>Providing health care to the client;</text> </paragraph> <paragraph num="(b)"> <text>Conducting quality improvement activities;</text> </paragraph> <paragraph num="(c)"> <text>Complying with legal requirements such as a subpoena; or</text> </paragraph> <paragraph num="(d)"> <text>Allowing a midwifery student to use records for educational purposes if client identification has been redacted or disguised;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid clinical indication;</text> </paragraph> <paragraph num="(9)"> <text>Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample;</text> </paragraph> <paragraph num="(10)"> <text>Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug;</text> </paragraph> <paragraph num="(11)"> <text>Using the power, influence, or knowledge, inherent in or obtained during the provider-client relationship, for the licensee’s personal gratification or benefit;</text> </paragraph> <paragraph num="(12)"> <text>Engaging in unprofessional or immoral conduct;</text> </paragraph> <paragraph num="(13)"> <text>Misrepresenting or concealing a material fact in obtaining a license, renewing a license, or reinstating a license; or</text> </paragraph> <paragraph num="(14)"> <text>Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed certified midwife may not engage in sexual misconduct. Sexual misconduct includes, but is not limited to:</text> <paragraph num="(1)"> <text>Sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered;</text> </paragraph> <paragraph num="(2)"> <text>Sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit;</text> </paragraph> <paragraph num="(3)"> <text>Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client;</text> </paragraph> <paragraph num="(4)"> <text>Sexual advances toward, or the request of sexual favors from, a coworker, student, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(5)"> <text>Discussion of nontherapeutic sexual matters while treating a client;</text> </paragraph> <paragraph num="(6)"> <text>Taking photographs of a client for a sexual purpose;</text> </paragraph> <paragraph num="(7)"> <text>Sexual harassment of a coworker, student, employer, client, or client’s family member;</text> </paragraph> <paragraph num="(8)"> <text>Sexual contact with an incompetent or unconscious client;</text> </paragraph> <paragraph num="(9)"> <text>Intentionally exposing any of the licensee's sexual body parts; and</text> </paragraph> <paragraph num="(10)"> <text>Intentionally exposing any of the client’s sexual body parts for a nontherapeutic purpose.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Electronic devices may not be used to record medical records and take pictures or videos of clients without written client authorization.</text> </paragraph> <paragraph num="F."> <text>A licensed certified midwife:</text> <paragraph num="(1)"> <text>May not make use of electronic devices and social media to transmit or place any client information online; and</text> </paragraph> <paragraph num="(2)"> <text>Shall adhere to the following principles for the use of electronic devices and social media:</text> <paragraph num="(a)"> <text>Every licensed certified midwife has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking;</text> </paragraph> <paragraph num="(b)"> <text>Licensed certified midwives are bound to observe ethically prescribed client-provider boundaries online as in any other setting;</text> </paragraph> <paragraph num="(c)"> <text>Client information shall be maintained in separate encrypted and secured files on personal computers and online;</text> </paragraph> <paragraph num="(d)"> <text>A licensed certified midwife has an obligation to report any electronically generated material that could harm a client’s privacy rights; and</text> </paragraph> <paragraph num="(e)"> <text>The standards of professionalism are the same when using electronic devices and social media as in any other circumstance.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Penalties."> <text>Violation of this chapter may result in the Board taking disciplinary action against a licensed certified midwife pursuant to Health Occupations Article, §8-6D-10, Annotated Code of Maryland.</text> </regulation> <annotations> <annotation type="Authority">Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: February 22, 2026 (52:17 Md. R. 875)</annotation> </annotations> </chapter> </subtitle>